Event ID: 616034
Event Started: 11/14/2006 8:24:45 AM ET
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Dinner last night, oh what a time you best. Week flew airplanes and played World War one and went to France and got lost. Sarah blocked the highway. People blew their horns. We hid under the front seat. God, you don't ever want to miss another one of those. We had a long and very productive day yesterday. It was, I think, a very good discussion and a number of areas, we have some very important work to do. Not only did we have great swathe pharmacogenomics, but the oversight was her intent. I think we came out with a plan that has a pretty good consensus. The amazing thing was your ability to be thoughtful that late in the day after having gone through all of that. It was amazing. Well, let's get right to it. By the way, if you haven't ordered Eurobonds you must do so by 10:00. So what you need to do is go out there and find Abbey, and that he will take care of you. But if you don't do it by 10:00 you don't eat. Everybody must fill out their survey which I always forget, but it is technical. And return that to Eddie. You will find it in your briefing book. So make sure you cross your t's and dot with your highs on all of your ethics stuff. Moon and and we also recognize that there are several of you who will be leaving at 3:00 during a break take it back to the west coast and even further west. So we will really rock and roll through our question -- sections. I don't think we have any real stuff near the end of the day. The agenda was thoughtfully designed by Sarah and team for that reality. Today's first session will focus on the report to the Secretary on a large project on jeans and disease in the U.S. senate. The time of our meeting in June the draft report had been braced for a 60 day public comment. The large task force carefully considered the comments and defies the Jeff report to incorporate this feedback. The final draft is at table seven of your briefing books. Let me also point out that I owe them as also provide each of us with a copy of the report and the [ indiscernible ] and the social environment and studies of teen environment attraction. So our work is clearly right centerpiece with a lot that is going on. Today we need to come to consensus. To gave me to come to consensus on the final draft report. And whether it is ready to be submitted to the Secretary. So we really do want to get this thing in front of the secretary. We were elected a full five hours for this important work, and I am so happy that I will turn this over to someone to lead us through five hours of discussion of changes that have been made to the draft report in light of the subsequent public comments received and the fact that the task force would like the full community to adopt as part of this report. So he will really take this and hunt and I have been to do this ourselves and the meeting. The outbreak clear about how this will go and it will be a very structured and specific conversation timed out to get us from here to there in time to finish. So if you guys just keep knowing that as you make your comments which we want you to do -- as you make them keep trying to find the plate to listen to your colleague and get to consensus perhaps the people may disagree on and we can move right. Get it done. With that -- hunt, you have to stop moving around.
You can't take that back. Okay. That you and good morning everyone. I apologize for missing yesterday, but once they chat occasionally gets in the way. And Terry's point of this being a five hour marathon to discuss this, I would point out what my students always tell me which is there is no penalty for finishing early. It's so if we reach a consensus so much the better and we can go on to other business. So what I would like to do -- here we go. I would like to give a little bit of background on where we are with the large population study report of the task force which hopefully will become the report of the community. For the benefit of some new members of the community and folks watching at home, quickly get to some of the subsidy changes that have been integrated into the report by the task force after what actually was a very extensive and useful process of getting public comments which we're dutifully collated and considered by the group. Was the yeoman's effort as this whole thing has been by staff, particularly Yvette Seger who has been tireless in pulling all of this together and keeping most of us on task. So let me move forward without any other delay. So for those who are new to this, the issue at hand is to examine issues relevant to the possible United States large population study which we define in this report as an approach to learning more about relationships among teens, the entire intent, and disease. And the goals of steady pulse was ongoing and once planned both in this country and elsewhere are to turn mechanisms underlying common complex diseases to inform treatment and prevention strategies and ultimately of course to improve health in this country and elsewhere. So the purpose of this session is to review the public thought process and the comets themselves and take go through the changes that have been introduced into the draft report as a result of those comments as well as a cue other changes. And hopefully by the end or shortly after lunch we can get to the point where me have reached a consensus among the community and we can finalize enough to prove a report for submission to the Secretary to early after the new year. Goals are good and hopefully we will achieve that. And I think we can. So what I wanted to is summarize the major revisions that have gone into the draft report since last week that, and then after I introduced all of those I will sit down and people be able to go through more on a point by point basis the different sections of the report, all to lead the recommendations that the task force has come up with and that this community has seen and draft form and a previous meeting and then address the question at the bottom of this slide in terms of the readiness of the report for submission to the secretary. Let me acknowledge the members of the task force. This list is more complete than the one you have in front of you. So you should look at the screen. There are some new members to SAC T H. As and thus to our task force. Others are all veterans his involvement in this task force and on the phone calls that I will describe and a moment was really a remarkable commitment to this process and trying to work with the public comments to take them seriously and integrate those comments into the report. On the right side of the slide these were also critical and really make is, I think, a broad based Task force. So because we brought all much younger when this process started it is word I think going to some of the historical events in history that led up to the report that we now have in front of us. We were first contacted Perry and a half years ago by NIH who invited the way in on the value of a possible large population study. Codes and with that our own party setting process we went through for a number of meetings for 2004 listed the issue of a large population culvert study art project as one of those issues that required in-depth consideration and us accordingly in October of 2004 the task force at I to describe was want. We had a session in 2005 but the March and team meeting and the traffic report was began in team to doesn't live under guidance from the NIH director that I will be more explicit about in a moment. We have more presentations at our October 2005 meeting. You all saw the first draft of the report at our March meeting and that was the draft that then was sent out for public comment in May, Jan and July of this current year. Those public comments were then collected by staff and considered by taskforce members in to the extensive -- quite extensive teleconference calls in September and October which the to us to today with a revised draft, hopefully the final draft report which we will consider today and hopefully approve with whatever modifications we decide we need in order to achieve consensus. So it is worth pointing out, I think, the specific address from the director the getting what our kind he was being asked to do and perhaps equally importantly what our community was being asked not to do. So we were asked to identify the key policy issues related to a potential but published a study and specifically does policy issues that should be addressed before undertaking such a project. We were asked to outline the approaches that could be used to address the issues that we're identified, but specifically we were urged not to address the issues themselves. Beaverton outlined the issues and to describe processes that the secretary might put in play in order to address those particular issues, but we weren't being asked as a group to address those issues ourselves. And lastly we were to recommend mechanisms that would best be used to address is identified it sees and this is very much in the spirit of the draft report have in front of you in order to keep with the request from doctors honey. What we weren't asked to do was to come to a conclusion about whether or not a large population project should move forward and the net the state. That, of course, is the 900-pound gorilla sitting in the corner. On the other hand we are essentially remaining silent on this issue, and I will describe that particular point a little more thoroughly as we are going to the draft report. So the final report that you have in front of you has the intent of appearing to be -- and you all will have to decide the extent to which we have exceeded it this appears to be entirely neutral. Simply to say that it is an open question of whether a large population study should go toward and in order for the Secretary and others to address that question there are a number of issues that ought to be tackled first and other issues that might only be tackled after such a decision has been reached. But here are those issues and here are some of the mechanisms that might be used in order to address those issues. This is the position we have tried to take at the task force and come up with the final draft you have in front of you in order to maintain that type of neutrality that I believe report urged to do. So but I'm going to do now is go into some of the public comments and the process as well as the specific comments themselves leading up to the draft -- final draft report that you have in front of him. And then I'll sit down and we can begin to roll up our sleeves and go to the specifics of those changes and the specific recommendations. So as I test said previously the draft report was released for a 60 day public comment. At the end of May of this year and that period ended at the end of July this past summer. The report was posted on the Web site and there was substantial targeted in now our reach to a variety of different groups. There was media outreach the head the NIH Office of communication that was posted in the federal registry and the guide for grants and contracts and then there was a colleague in now that was sent out to a whole variety of listeners. In total about 48,000 individuals were informed that the draft report was ready to be viewed and commented on, and I think we have every reason to the conference that anyone who was interested in it and then do about it, at least one if not multiple sources had an opportunity to offer their comments. From that list of 48,000 obviously many people were busy. Sixty-nine return, this, but those were as you will see in a moment very substantial and very useful. They're is a summary in tap seven of your briefing book and it goes through literally in summary form. And then you have sent to your home offices this public but some of the pot but many of you may not have which is a compendium of all of those comments and makes for enlightening reading if anyone is interested. And they're really work from Terri CNN comments and more important some more consistent comments that came through repeated the four very different kinds of groups. And those are the ones that I think we felt especially that we either were not there and our intent and the draft report or made us wish to provide more background information as I've described shortly. So the 69, is that we receive represent a number of different sectors that had received notice of the draft report. And the vast majority, about 60 percent of the comments came from three groups pilot on the slide. About 25% from academically based researchers as one might expect. 19 percent from professional societies that there was a typical Macintosh the PC handoff. That is the professional societies they should the box at the bottom, not the individual and the various government agencies provided 17%. So those three groups, an economic base researchers government and professional societies offered about 60 percent of the comments that came and and then a variety of other constituencies and factors make up the remaining portion. So even though there were only 69 individual comments and many of being quite comprehensive with a total of about 600 pounds that address specific issues summer and the draft report. The wonderful staffed develop a coding system which was developed to categorize the comments into the four major policy issue categories that we already decided on believe the Arizona traffic as well as public engagement. And those comments were then viewed within each of those kinds of categories. Various task force members, usually to if not three were assigned to each one of those bands of Commons in order to go through those and analyze them individually it in terms of whether they were particularly sensitive at the to address our with that they simply were requests for clarification or whether there were someone who just misread what we said or intended to say, in which case it little bit of work pricking was sufficient. But those task force members identified the major themes that came to this piles of college and decide on the comments to be incorporated as we discussed in faltering to teleconference calls in September and October of this year. And so it is those comments integrated and discussed as part of what probably was the other five hours worth of telephone conversations among a fairly but people to decide exactly which changes should be made and how we ought to make this change is and how we can best position the draft report's you have in front of him. So there were some major themes in the public comments that not want to go through because I think it gives you a sense of how the report might have shifted from the original draft report that you sought to the final draft report that you have had for the last week course up. One of the major comments was that the tone of the original draft report was decidedly not neutral. Most people read our draft to say that we were very much behind this and in fact to some people's reading it appeared that it was a foregone conclusion that this would go forward and we were simply providing guidance on how it might go for it. Accordingly then the role and charge that we received clearly had not been understood and that was our fault. We had left that out as clearly as it need to be. So they decided post tech clarify explicitly what our charge had been calling the similar kind of point I made a number of slides back in introducing these changes and then we went through carefully in order to examine the town of the report and make sure that we in PAC were being neutral and our language and making sure that we were covering all points of view that might be relevant to the secretary as he reaches a decision. Another major theme was that more information needed to be included on the already existing cohort studies of various sizes and shapes that were already being funded by groups both in this country and elsewhere and more affirmation need to be included on the types of interdisciplinary research at would be necessary to mount a large population study. And those changes have been made and people go to the details of those changes in a bit. The number of comments pointed out that we had not sufficiently addressed issues of socioeconomic status and economic factors that were relevant to how costly and what kinds of issues would be relevant to a but population study. And so sections on those have been introduced into the final draft you have in front of you. We were urged to expand our discussion of what is obviously a series of complex ethical privacy and care facility issues that we perhaps give short shrift in the original report. And that section has not been significantly expanded and will describe that in a moment. There were specific suggestions among the public comments at the task force that were quite good in terms of mechanisms for greater ethical and independent insights that would be necessary for a but population study or one to go forward. And then lastly we were urged to be clear on the extent to which public engagement was being emphasized. And so we may be significant rearrangements within the report, not so much the content, but a rearrangement in order to provide what we think is a more appropriate if this is on the airport of public engagement book before a decision is reached and after should such a large population study go forward. So that is in and not show the essence of the major changes and the processes that have gone on since last reviewed the draft report. I'll stop at this point if there are any questions specifically about what I have presented thus far, and if not then I will move back to my seat and as I sat will roll up our sleeves and began to go through some of the specific changes with an eye toward not word is the thing Perce because none of us will live long enough to get through it if we do that, but rather to reach a consensus that the changes that the task force made are appropriate or not appropriate and deal with major issues of language and text where there are some major issues, but none of our way through to reach a consensus on what the final report should look like and then go into the recommendations of that that the community saw last time and that the task force has in a few cases modified. So any point or questions at this point before we move on? Grade.
Okay. And since I'm sitting where I'm sitting if the people on the left-field seats, if you are waiting your arms and I don't see you to something it the less polite and waving your arms and we go from there. So throughout everything at present now I am referring to line numbers rather than page numbers since the draft report is organized and that way so you can follow along in your hand of if you want to as we go through this. So the major revisions in terms of the overall organization that I just alluded to word that previously there had been to different sections on public engagement and the importance of public engagement. One in the beginning and one in the end and in terms of the public, is that fail to provide the kind -- fail to convey the importance that we attach to this particular issue. So we have now indicated that into a single chapter within the report which hopefully improve the logical flow of the report and eliminates some redundancy and increases the emphasis for any leader including the secretary. So the content has changed a very much. It simply is emerging as two sections and putting them together so that it has more emphasis. The other major revisions in terms of the town of the report, we have made a significant effort to change the language to be more neutral and balance in response to the public comments. In the spirit of the request from the and I ate director to raise issues for exploration and not to other insurers were discouraged efforts to pursue a large population study we have attempted to go through this because of these public content change language, most of which has been relatively modest changes in the words simply to reflect this nature of perspective. The example here being that we would say such a study would do something as opposed to the study will do something which is the type of language we had before that many of the public, to respond to. So you will see for those of you who have read through it or to read through it on the fly, you will see many examples of that as we go through. So the introduction, the introduction has been significantly expanded, and I think clarified in response to the public comments. First of all more Bacharach has been added on the level and the specific charge related to this report. We provided more background information related to the design consideration the portion that has come not from in IA to principally from the in 8GARI led effort to examine design considerations. That is now summarized in an extensive section. And then there is an overview of the public comment process and the type of input we received from various stakeholders, all within that introductory section. So any comments on the introductory section okay. Seeing no living on a bus we will move from there. In the second section and second chapter is on the scientific background. As some of you will recall that began in a previous draft with an immediate description of the international map project what the glossing over of the human genome and the task force felt that even though the human genome project is an ancient history now it is not that much into history and so perhaps it wanted some discussion and we have included that now before a description of the international project. And then in response to public comments we expanded a section very substantially on already existing covert studies and the United States listing them and going through in a brief description of each of the ones that we are aware of that included. And that was a very consistent comment from a number of the public comments. And so we introduced that change as well. Any discussion on either of those two changes? Okay. Other the caffeine hasn't kicked in all we are unable. This is good. The third chapter, now we get into the meat of the various policy issues. In terms of over the changes we first expanded a section beginning at line 931 entitled capacity to conduct interdisciplinary science incorporating a number of concepts of were raised by the public, enters and then we specifically mentioned two of the existing cohort studies, the Women's Health Initiative and the National to the study as potential models of the kind of interdisciplinary Research that would be needed in a large population study. Been a little bit later there is an expanded section of the need for partnerships to address a recurring theme in the public comments about the wide range of stakeholders and the potential for a large number of different potential partners to the league this but population study were the decision made to go for it. And then there is an expanded section on access to data and materials beginning at line 1037, and encouraging concepts raised by the public comments that the task force members felt were important. And then lastly under research policy issues. Added a section recently announced, and I believe later this afternoon we will hear more information on this on the in IHL genome wide initiative studies. And then what I think a task force felt was an important addition to expand the discussion of what we meant or what people who considered large population studies mean by the work environment, previously this was a small footnote in the introduction and public Contras fought that was not providing suitable Ephesus to this. So that was pulled into the main text and we recorded significant feedback from public comments to ensure we had a broad and workable and operational definition of environment.
You have in your biological factors. Is that environment physiology, is that the innate physiology of the individuals? Is that really environment?
Now you are making me remember to end the task force has raised that issue. Yes, I think it relates to an infectious disease, for example, that the infectious agents are biological on the one hand.
Okay. So the way it is written it really implies that when you say physiology it implies the innate physiology of a person that is a reflection of their genetic makeup obviously.
But it is also a reflection of the environment.
Sure.
So the out what is the combination --
I've just sent you need me to explain it a little better in the way that you actually meant.
Okay. We will fight that and give a more extensive example the. Any of the points on this because this actually is an important change in terms of the balance report?
Yes Paris.
On the task force we actually had an extensive discussion of this set of issues visit to the environment. And one of the reasons why it is a little brought was it was a deliberate effort to leave it brought because a lot of the public comment, the specificity was leading in one direction, but besides that if he explain it more was also the point was made that we actually did not provide any kind of brought to the discussion. So that was one part and the other part was as was said before we want to be sure that we provided at least some examples that could actually be used in the decision making process that came along to. So it is being a little brought with actually delivering that if I remember correctly from my discussions because they were connected. And the other community members can chime in on that.
As the report says this actually is an issue which would presumably have to be discussed. So we our sense discussing that this lab or any other groups like in order to determine what in the context of a large population study is meant by Environment, we know what genes mean, but it is less clear what we mean by the environment.
I know, I does want to say I applaud the task force for looking at the bread. So I think it is very good to think broadly year, but I do agree with Michael that if you look at all the other factors that harken external and if you look at physiology and say there are genetic underpinnings of physiology it is a little bit different from the other.
We will force that out. Think full. That is useful.
I had two thoughts, one was under the second bullet about capturing diversity and adding geographic diversity to the record in strategy. And then under the social factors in the second to the bottom standard is not included there, and that was one comment from public comments that I think we might have missed. And I would add my own of cultural under Social.
Cultural and you think gender should be added as well as a social factor as opposed to sex which is obviously out environmental. You are making that distinction, am I reading that correctly? Okay. Other comments on this particular point to give a day. Thank you. So that is the Research logistics section and the changes that were made there. The third policy issue -- sorry, that was research policy and now we were onto Research resistance. That is the second area. And in this area we again change the definition of the Environment and pulled it up into the text port clarity and expanded the section on recruitment and enrollment at the information of that came from a report to buy it trawls to this community and added another section on socio-economic and lifestyle factors which was not in the previous one. Also under Research logistics' we added a section on multidisciplinary research teams repeating the theme that we also had on earlier. And then we added a section on coordination across multiple institutions and health care systems beginning at about 1355. Again that was in response to public comment. Any questions on this logistics'? The third area is regulatory and ethical issues. We significantly expanded the section on privacy and confidentiality and incorporated a number of comments which we received on the world privacy for as well as a number of other comments from some of the other, tears. And addressed specifically the need for the privacy of a severe blow to its consideration and the need of our privacy impact assessment and third party is up private records. So in essence the section is not going through a more detailed the kinds of issues that would fall under privacy and confidentiality which is both from a public standpoint as well as from staplers who might be involved in such a project and of these the critical ones. Also under regulatory and ethical issues and again and responses to a fame among the public, it's received about the need for ethical overset be added the suggestion of an independent ethics review committee that becomes the recommendation of the task force which we will describe as we go through all of the specific recommendations, but the text for this begins at 1760 the 1789, but that is the text and so it is worth a lot considering that. About said discussion or questions on any of the tennis on regulatory and ethical issues to Cuba by okay. Thank you. The fourth area which actually is an integration of what had been the fourth and hit areas is now entitled public, health, social and economic implications. Is a merger of what had been public health is a separately above. And we added to that end integration above but of the language on the potential economic impact of a large population study as well as of course as I said adding the word economic to the title of the section. About one relevant to the social been indications is adding, and he text box to emphasize our previous support -- previously announced support and continue support for the Senate nondiscrimination legislation was the secretary lose focus on that particular issue which we keep reminding him of. So that box reflects a gain both, in a sense that tobacco were want to consider going ahead with a large population study, the kind of legislation already proposed under the federal nondiscrimination Act would need to be in place where large population study to go forward. And if the task force of the would be unlikely there would be public support for such a study in the absence of nondiscrimination legislation. Upset that is now described in this section. Questions on that point or in this section? Kim?
Yes, I was just wondering from the standpoint of economic impact and maybe elsewhere, discussions of the kind of balance with regard to the costs and economic impact on existing research endeavors, so this describes the economic stimulus that might address disease that may have concerns about --
Cost of the project?
Cost of the project an impact on research and for structure.
That is an earlier section I believe. They're is a section somewhere, Jim, and I'm trying to remember where it is where the cost of the project and it's impact on the rest of the it research enterprise is discussed. But I'd think we both like that and if nothing else in this second-half -- I during two different things here paid 66? We don't have a paid 66.
12007.
I have paid 25.
Okay. So it may be that it is worth -- because what was discussed in the beginning, the $3 billion figure which is in the paragraph that begins on line 913, that paragraph we might refer back to in the late resections so there is a balance of the to economic issues. Okay. Good point. Thank you, Jim. Any other points on this, Barbara?
Did we pass by line 894? I'm sorry, I'm a little slow.
1894?
Yes. I am still a little uncomfortable with that because I think most people when they think about a large population study deal that it would detract money from help disparity research which mostly is social and economic and environmental factors. And I think there is something to be said for the Research and this could contribute to that. Maybe some acknowledgement that there is that tension between the competition in the areas of health disparity issue might be addressed more directly, do you know what I mean?
Any other community members have an opinion on that point?
There is certainly no harm in putting out that kind of tension if it is widely perceived.
I agree with you, Barbara, and a sense. I think it will actually add to the amount of research that could come out of it. Is that what you are saying to keep you want to fly in here that this impact could be a the impetus for increasing the Social Research, right? Because we must look at the ramifications of the project and in doing so that should lead to additional research in that area?
I actually don't know, but I think most people, which is a dangerous beginning of a sentence, feel that genetic research and the genetics area polls money away from old-fashioned public health researchers looking at health disparities in terms of social determinants of health. Here we are to be to the battle of the argument by saying it will indeed increase our knowledge of social disparities and indeed it might, but I think there is a perception on the other side more strongly. So if we really feel it might contribute to health disparities, address that they little more directly because it is downplayed in here. And so it opens itself to criticism I think. Okay.
I think I and stand the point now. Soviet?
I don't know. The public comments that we are trying to respond to an evidence that we have, I don't think that is something that has been expressed in the public comments or in any evidence that we have received that they think that it might decrease funding in all areas of research because you are going to put a lot of funding into a large population study. So across the board they might decrease research. So I thought if we should add in something into a report where we don't have some evidence for it or we haven't received strong public comment on that issue.
Are their opinions on this point? Joseph?
I think I understand. This actually came up in our conversation about the general discussion regarding if this goes forward how it will affect looking at funding and similar types of various -- areas. My understanding was the wisdom of the task force was to highlight as much at diplomatically as possible the issue itself and knowing that it probably will come back to be reviewed -- it was the perception that what you are discussing and that your description is of face. It was just that it was looked at in the context of concern across the board of similar types of work -- work and where this type of Richard would play a role. So I think we are strongly putting forth that this whole section should be included to have a dialogue about some basis for discussion and decision making and leave it at that. I think we should push it below harder for more call but I think with the wisdom of the group we should leave it at this level. And I do have a comment, actually it is a correction.
Before we leave this point --
All come back to it.
I think what we could do, Barbara -- and I'll make this proposal to the community, is that in that paragraph on page 25 when we are discussing the impact of a large populatiopopulatio n study on the funding of other biomedical research, that we expand that to flesh out what we mean by biomedical research to the behavioral research, help the Spurs is researching such a and make it clear that we are not just barely talking about what we often mean by biomedical research.
Great. That makes sense.
Okay. Jesup, over to you.
Thank you. I have to corrections if I can. It is on-line 1914.
Yes.
It is just says socially defined and then on line 1921 at the end of the sentence it should say stick with vulnerable groups because you are mixing to cut you have the ethnic groups that if you look at the temples you're giving those are both social and other groups as well. So sticking with the hon. lips.
You may drop the word hysterical?
No, the second sentence where you say these include racial and ethnic groups and that list the number of groups and they actually are somewhat socially defined and some are not. But they are not ethnic ratio. All of them are not ethnic and racial groups. The second sentence.
Is, but I'm not reading that sense to suggest that the blind, gay and lesbians are social and ethnic.
I'm sorry, what? No, I'm saying that these Arbor well, we should -- racially ethnic and socially defined groups. What I'm saying that the way you can find groups is not correct.
I don't think we are defining them and that sentence. So what is the exact correction.
I would like to see the you stick with hon. because it better defines the group. That's on sang.
So you want to delete the second sentence?
No, what I'm saying is the sentence should read, you should include groups such as --
Keep going.
And keep the rest of the sentence as is.
The drop out the racial / ethnic, you want to delete that?
Yes, sir.
Okay.
Don't you have concerns that some others reading that would feel that there is a glaring omission?
Yes, I think whenever we have done this before and we have run this like this people have always said, there are other groups that would go here, a chapter. And it is mostly just if this is an example that you have it this way, but my experience is that we have had to put reports like this together. People always say something is left out or something is included that shouldn't be there.
If I'm calling you correctly you are proposing to leave out racially and ethnically defined groups.
Well -- all right. We would not want to lead out historical adorable groups.
Never mind. Forget I said it. Forget I said it.
Now, I realize now what is being said, and I was reading it slightly differently than that because I was trying to read it from another lens. But I'm kind with that part. But I will stick to my earlier comment.
Changing the word culturally to socially?
Yes. That seems appropriate from my vantage point.
Other points?
I just have a question. As you mentioned because of the public, as we are highlighting the genetic conservation legislation, but in the table of contents it is in flight, and I imagine there will be quite a few people, the first thing they will look for in the table of contents is where is that addressed. So is that intended to be in the table of contents somehow?
We can certainly accept.
Because I know some people will immediately get to that in no want to know where that is.
I'm taking this as a sign that we are pretty close to a consensus when we are worried about the table of content.
I like the discussion on the economic impacts, and clearly the paragraph highlights the importance of looking into the potential economic cost of this was published a study. Does the task force feel that there should be an actual recommendations to the Secretary that there should be some kind of independent body or something that provides estimates of how costly such a population study might be to provide some kind of basis for resource allocation to what will they make the decision?
Well, we certainly did make it sort recommendation to that point. I think when we go through the recommendations that we drafted the bill look for opportunities where that would be covered. Clearly someone has to come up with an estimate as part of any process to go forward, but we are not. So that is the intent. We didn't symbol that out as one particular recommendation and said put a price tag on this. But as we go through the recommendations, I think that is a point.
I was just going to comment that in the task force discussion actually the discussion of whether that discussion should be included in the report at all -- sorry, my comment was specifically in response to your question. In the task force discussion there was a great deal of debate about whether that discussion should even be included in the report. So there was certainly not overwhelming support for its inclusion at all. So the question of the recommendation then, I think is one that is what a great deal of discussion.
Other comments on this section before we --
It a point of order, if I can. The reason why I stopped the conversation on my point is I think it will take a little bit longer discussion and I was wondering if I could indulge your time to explain more and see whether it is relevant.
We are doing well, so please go ahead.
I don't want to take up the committee's time. Trust me, it is they little bit broader expansion and I want to ensure that when I make the recommendation the wording is correct. I don't have the wording right now.
I think our intent is to cut I think we all know what we want to say. It's want to make sure the birds are not subject to misinterpretation.
That's correct.
So clarity of language more than the actual intent.
Thank you. I appreciate your indulgence.
Anything else on public health and social and economic implications? Okay. The final chapters on public engagement which, as I said previously, barges what happened to separate sections in the original draft, specifically here and we have now added a section on one example of public engagements, the moderate focus groups and the National to the study. We added a section on public consultation initiative recently funded by an ATR I to describe that project. And then we added a section based on recent -- recent survey data based on the presentation that was made to this community. And that is all now in this section. Comments or questions about what this chapter is doing or section is doing? Okay. Said that takes care of the text. Now we have what I'm sure will be a little less easy and straightforward which is to actually look at the specific recommendations themselves. And as a preamble to this, let me say that what I think we are looking for is to achieve consensus on what the community would like to recommend and move to consideration of approval of that content. If there is specific language that some of the community feels needs to be improved or is unclear or is inappropriate or what have you caught this is the time for us to do that. Minor works within of changing this word to that word and this, here, that kind of thing we can deal with outside of the context of the community meeting and do that by sharing information by e-mail with the dead and Sarah. We do want to get on the intent of these recommendations. That is so we all go away with a sense of what it is we are all recommending. So there are now 18 recommendations in the report. These are what we're previously called options were the task force felt from the abysmal draft was sort of a week word and not particularly responsive to the NIH director's request that we actually make some accommodations. So we now have a recommendation is divided into the different sections as you see on the slide. And then when beginning over arching recommendation that the task force but was necessary in order to put into context to all the subsequent recommendations. At this table that is on the screen and you have in front of you is really important because it really makes two points. The first point is that the vast majority of what we are about to look at you have seen before. Best of these recommendations are essentially unchanged except for some minor wordsmith thing on a version which we all saw before and Leslie stood behind. There are three specific recommendations here that are either entirely new or substantially new wording, and thus will take a closer look at as we go through this. You have in your packets to documents that are relevant to this. One is called public comment contractor versus mile Drive changes and recommendations. And that sort of gives you the reader is digest version of the changes that have been describing. You also have another sheet that's called revised contract that replaces case 31 in the report. There was one recommendation that was left out one by Pierre clutch on our part. I will give it to you on the side as we go through. So I'm going to propose going through all 18 of these recommendations. We spend most of our time we look for three that are totally suggested and probably less time with the ones that we have all seen and supported before. I want to provide comment committees feel we should. So the first new recommendation is this overarching principle recommendation that needs to -- that the task force called the to be in place in order to put all of the subsequent back on this into context and to allow them to be presented with some clarity about what be attended. Some of these recommendations over all of vortices that the secretary would be to address prior to making a decision about a large population study. Other recommendations would need to be addressed at all unless there was a this is to go aboard with the large population study in this is intended to provide the context that would tie does to different types of recommendations into place. So let me read this -- not that you are not capable of reading it yourself, but let me read it anyway. As part of the process for determining whether to undertake such a large scale research process and prior to a decision being made the secretary should initiate a thorough consideration of the full range of policy issues outlined in this report. The secretary could.
-- should consult and to gauge the full range of partners during the decisionmaking process including the public at large and the full scientific community, a wide spectrum of government agencies and the power sector. So this recommendation as to intent or intends to make two points. Want, that this entire group of policy issues must be addressed prior to a decision being made and that it would be inconsistent subvert with the fact that these issues are being raised and that there are processes one would be to go through in order to address these issues to make a decision about a lot of business that the absent that for consideration of those issues. And then secondly there was in fact a very broad range of potential partners in the public and private sector and the test was felt was important to articulate that within this recommendation. Emily?
I just noticed if you went down to the public had on your response to recommendation number two that he states that you should also consult with Congress to get there by and basically. This is left out of this overarching recommendation.
I don't know if you want to think about putting them into this because they definitely would have to appropriate funding for it. And you would want to engage them early on as well.
So you are suggesting that the advice of the community would not be just as part of the appropriations package but as part of what to decide to go for are not?
I think if you don't have [ indiscernible ] and you want to get that by an early. Be at least want to educate them that this is coming, why it is coming call what the rationale is and keep them informed about this all pre decision process so that when the decision happens it is not a disk -- surprise to the gas you must write a check.
It without worrying about how we need to work that other members of the Committee have in opinion on that point?
Let's just at policy makers to the list and include state and local level.
I see a red light down there.
I thinking at the beginning of this overarching recommendation we should say as part of the process for determining whether to recommend that Congress undertake or recommend to Congress the attain -- undertaking of such a large project possibly to that effect that you put Congress and their and that the Secretary to all the other of reach in order to side with a to make that recommendation to congress. In order to do that you probably do want to get Congress to a ball that some point, but I think it does perhaps make sense to get Congress and that overarching representation at that point.
I want to be careful that I opened Pandora's box here. You did alluded earlier in your early comment about the tone and to keep Pete . This is a neutral statement. So there is no way that anyone can read it that I can see that shows the community has any particular interest in doing this. It's just reads that if you decide to go play in traffic, look both ways and don't get hit. That is as opposed to go play in traffic. I just want to make absolutely sure that we have no intention to be any more publishing as to lead this is actually a good idea to do with the appropriate caveat as we are by to describe in great detail.
Okay. That is an invitation to the committee to address that point. I think the sense of the task force that is until one had the answer on a number of those issues and knew what the answer was that we would want to necessarily recommend either for or against a large population study until we had all the data in.
Let me to ask it this way then. And I'm being careful here, extended care will, I hope, but what I'm saying is there must be some reason why you'd want to have all these things done. Because at the end of the day there is some potential that this might be a reasonable thing, like a good thing of all these cabinets were checked off. And so what I'm wondering again is that the subcommittee is saying it is hard to tell whether you are being dragged kicking and screaming into this recommendation to do all these things or this actually could be good and it is important to all this work or let's don't do this thing and I will show you a whole lot of work you have to do before you even think about it. Which way are we coming to give.
Kevin, I saw your --
Now I am completely confused. I thought we were on the same pace and I'm not sure now any more. The idea was to be completely if that is at all possible to be as natural on this. And I guess I am still not trying to see, are you saying that this isn't a neutral? Are you reading this has not neutral?
If I am a person from outside of this, I could read and any which direction I wanted. So if you want to be absolutely neutral this is as natural as you can be. You can determine whether you are interested -- I'm asking. I don't think he can determine whether you can determine that this kind of a large population study is actually a reasonable thing to try to aspire to if it meets certain, you know, tests. Or this isn't a great good thing, but if you will be so on wise as to pursue it then you need to meet these tests. Are you part of the group, I guess, that is saying is what population study is actually a good thing for the country under certain conditions or it is not. I just don't know how people will read it.
My feeling is it is all right. I like that natality and I think that for those people who are interested in looking at the more nuanced take, the report does lay out clearly I think in the pros that if certain conditions are met this could be a good thing. But there are caveat and I think to come across and the overarching recommendation in a partisan one is probably exceeding our mandate. I like that neutrality.
I'm just listening to this dialogue and I think what I'm hearing is does this community want to make a recommendation that at least the funding to explore whether this is a good thing should be coming toward? That is in terms of moving to the next level of decision making. Is that really what the community is interested in recommending? At least that much investment be made by the government to determine at this is a good thing to move forward.
Is that what the recommendation says. Says the secretary should initiate a full discussion element in this report. We can't do that for free.
The chair read the point it is not exactly neutral from that point of view because it is recommending at least to some extent an investment of government dollars in the exploration call Phase I or face zero whenever of the project.
I would argue that in fact that is what makes it natural because if you don't recommend the initiation of a thorough consideration you are in fact making the decision because without a throw consideration this doesn't go forward. And so the idea is in order to achieve that Fidelity you really have to understand what is involved in choosing either to do or not do this because there are consequences either way and you can't really know of those consequences unless you do this borough consideration. So I think this was built into our consideration of how one does receive neutral position on this because you have to say, we can't answer this question until we to make it consideration of it.
I have Allen.
If I understand correctly which I think I do I would agree with him. I would think that for instance we might put something in here that says because of potential benefits to health of such a study are great but the issues underline are so complex that there should be this kind of -- but I think for this group there has been a lot of time and expertise and community input to come out and just say absolutely nothing is not benefiting the American public to the degree of [ indiscernible ]. Unless we say there really is something here that may fall under certain bureaucratic reports that says there are 18 different ways of looking at this. I think earlier several meetings ago we had a hands up show around the table and there was a fair bit of excitement of the group for the potential his the other side there are many reasons why it should go for it but that it had real potential. I think some of that has been lost as we go through all of these changes. And I think over all the changes have been good. They have added debt and wants, but I think we still at some point me to say their is reason for picking about all of this.
Point heard although I do recall that the public comments were pushing us to be completely neutral. And so that is what we try to do. At the community can obviously decide differently.
Not all the public comments represented the best majority of the American people. I think that definitely we need to record the public, taken into consideration, but I think it is this community for getting its duty to adjust say, see lever happens to come across we will take into the general consensus of those comments. And just where those and make up the report.
Other comments?
Looking again at this baggage and prior to a decision being made at think that perhaps sully that helps reinforce the point reading is making that that sounds expert cautionary, almost. That language in there. And it almost looks a little condescending but you are saying to the Secretary -- you are already saying you should initiate this process but prior to a decision being made. I think that is a given that you would go through this process about making a decision. I wonder if that language comes across a little condescending.
I think the intent was not to be condescending. The intent was to anticipate that one perhaps reasonable response would be to go ahead and start a small scale first base of the project itself while simultaneously going through all these other issues and the task force felt that probably wasn't the right way to do it and the issues need to be addressed first before initiating or consider adding initiation of the project. If there is other way to work that -- it appears, listening to one person on the table chances are it appears condescending to the others.
I'm just wondering I think the overarching recommendation is good. You are saying go figure out whether it makes sense to do this and then afford. I wonder what the Senate does when they aren't ready to put money into it they create a statement of the sense of the senate. So it could be as a group put a statement in here somewhere in the preamble or introduction that says the sense of the community? Is that the proper it?
Will recall a slide that showed very early on which was that we were specifically asked not to say whether this is yes we should go forward or no we should not. We were asked to simply outlined the issues that were relevant to the proper people making that decision.
Will call me could be in a separate document. I'm hearing people say that this is something the community has shot at the door and says we should do it. Just an idea.
The community could reasonably decide it on a that was a pre are not.
I'm going back to the side that very specifically says that we were not asked to do. We were not asked to come to a conclusion about whether this should move toward. If I understand our charge right it would violate our mandate to do so and moreover I don't think were qualified to decide. I think this natural statement is three dead and I think that the new ones is applied with the rest of the report. And certainly it would change the tone to remove the hyphenated calls. This does indeed imply that would be done prior to the decision being made. To some degree board spending might be appropriate with this over arching ambition. I don't think it would be unreasonable to keep read up that if people find that somewhat insulting or condescending. I like the neutrality.
Okay. I have justice and -- disagreed and Kevin.
I think it is important in the rest of the keenly the order in which the overarching stairwell was written was one of the last things that was done after a full review of all the work. That is where it was, from. It was in light of what we cannot do. Given what we have already done. And I think it is important that those the are reading this, it came pretty much at the beginning of a very long arduous reprocess that took into account many things. I say this more for clarity. Because a sense of this -- and I guess in my neck of the was the call this the would factor. Did we are to be not was out of desperate I think it is critical for us to know that the community worked very hard to come to this point and it is important for people to realize that were this overarching, was was more of an introduction and taking a real good look at this set of recommendations to me will answer a lot of the questions that people are bringing up, a lot of the concerns to plopping it up. Won't answer everything, but I would suggest that, not to say move forward, but I do want to put it in perspective.
Kevin?
Again, I guess what I would like to make sure doesn't get lost as to as we wrestle with this is the sense that I don't think the task force or this community would recommend to the Secretary to initiate a thorough communication of something if we didn't think there was potential benefit. Why would one bothered. So obviously the more bragger one decides a topic is worth investigating obviously the greater potential that topic must tap. Otherwise why bother. So I think inherent in this from a perspective, one could read there is a great deal of interest. They're is a great deal of possibility for this sort of thing. I don't think we need to overstate that. That can understand one can overlook this from a riding a respected but that is the whole point of the openness of this statement. People calling from a variety of the agendas can read into it what they want. And also I'll see that it is either too optimistic or too pessimistic. And I think we would get that from this reading.
Read I am of pausing for skipping you before.
Actually on happy you did. Kevin, I was with you all the way Intel just when you jump off the bridge, but I was right there holding your hand. I think though that you were speaking very specifically to the Michaels legislative history point which I think is actually pretty right on target. First of all I think that this this such a contentious issue that we do, I think, deserve to be clear to people about where we are. I think the plus factor, Joe, is absolutely right there. It is not fair to the people participating in this debate to not be very clear. I think that the legislative intent that Cavan said it is right there. And it abroad agrees to that which is why would anyone ask the Secretary to spend money and all the trouble of going through this if this did not have the potential for a promise to do so in other words if he thought this was the dumbest idea not to man you would say, stop now, screw it and go do something else we're the. Because I need to understand your sentiment internal bodies. So I need to be really clear that I now have to speak for you. If that is what you are saying people need to adopt that through our community that we are saying that it has the potential and therefore to all of the caveat. And that is as far as we are prepared to go. But I must be real clear that is what you're saying. I will take off my moderator will and say as a member of the community I am putting a lot more than fair to submit to a consensus that that is and that what we are saying. I am urging some degree of clarity that says this is important enough to get at it and to get this thing out.
I got two people and the to, but let me remind people, this is simply a recommendation. This is not our and statement of final conclusion. This is simply a recommendation that one these in order to make sense of the other recommendations. There will be an executive summary and a conclusion that has even been written yet. So there is plenty of room for language if we want to say something similar to what Allen was addressing her lip which was that there seems to be enormous potential for a terrific things to come up with respect to both science and health. That is in the text itself and presumably there are ways of point that out an executive summary in conclusion without it being a recommendation like this which already is contorted the endless line it. I'm not sure I would want to make it any worse. I have Robyn and Sue Ann Allen.
I am just curious at the outset to find out the task force's thinking behind recommending that the Secretary undertake this extensive process as opposed to Saks serving in its advisory capacity. This is to actually collect the information from the various sources. I'm wondering what the mechanism is where the Secretary to go out and to get this wide public input as opposed to this being a continuing function of Saks.
I think tax force is responding to the doctor's charge which is specifically says identify the issues but don't make an effort to address those issues. That is what we were told to do. If the secretary wants to to see what other recommendations we agree on a comeback and say great that chapter to we want you guys to tackle the following five issues and give us some feedback, then that becomes the second round. But I think we were simply responding to what the doctor was requesting of us. At least that is my sense of where we were. Alan, you are next.
I want to put the associate myself with a been reached, and have comfort him and help prestige Cavan from his present job. I was not try to suggest that the community come to a conclusion that this study should go forward. I was just suggesting and I agree very much that we should not necessarily be here but should be some place. And my concern is I think what Cavan expressed that one can look at this now and see whatever you want to see. And I don't believe that the community having looked at it a lot and got a lot about it complete comes out and does that having been able to see whatever they want to see. They're is a lot of complexity. But some place in our Burbage we need to make that point.
So before moving on from this recommendation of want to specifically ask for a sense be running the phrase and prior to a decision being made. The fact that it is bolted in your original documents, the bowling has nothing to do with anything. But it has done suggested we could just as easily removed that phrase had not us with any of that than I think the community said make itself heard on that point so we can decide what the final should be. So maybe even just a straw vote kind of show of hands of how many would like that phrase removed.
That looks slightly more than 50%. Anybody feel strongly that it should or must be there? Okay. That is a good sense of the community. Thank you. So that is the overarching recommendation that sets the tone for all the others that, subsequently. So under research policy this is the first of the recommendations. It is essentially unchanged from what it was in the previous draft. The secretary should continue to promote and facilitate ongoing consultation with the public, and National Committee and public sector to explore of the charities were collaborations. This didn't seem pretentious last time. Would anyone like to -- it just seems like you left of the end of the sense that people give you recommendations and isolation. It should be up to these were cooperation of but population studies and it seems like you sort of left the sentence hanging.
Okay. That is a word is moving. In a sense you are right. There will be a list of recommendations read by some people have some text and even at some detectives all right. So each should stand alone. Right. So in what is being prodded to me is that in your text -- and this is why it may be difficult to few recommendations as stand allow text. The lead in to all recommendations under research policy -- the lead in is if a decision is made to move forward the following considerations should be addressed. Said this is a recommendation that has no bearing whatsoever if a decision is made to not bother to go forward. And now we could take that lead and phrase and have that be a starting price for each of these recommendations. The task force are of got tired for that and makes it obviously repetitive to have that in front of every single one of them, but that is obviously the intent.
We all know that what people read is recommendations and even though you are a Nobel laureate writer the people will focus on the recommendations. Having said that you will make everyone numb by doing that.
That this recommendation one. I've seen no particular objections. Recommendation to, we also have seen before and essentially unchanged I wish the agencies and appropriate congressional committees to ensure there is widespread support for sustaining a long-term stable investment in the large population study. So I'm going to change the last word given that we have always called it a lot Populism steady at about the project. So that work should be changed. But with that change -- I would love to deliver this point, but after the discussion about the neutrality and language I just wonder about the word shore. It jumps out to me and I wonder if we consider the word assess the set of a share the they has a different feel to it.
Should assess whether there is?
Yes.
I think the sense was there is no point in going forward with a large population study unless there is guaranteed to the extent that there is never any guarantee of funding for government programs that someone is at least realizing this is not just a day [ indiscernible ] this actually has ongoing support that is necessary in order to benefit from what might emerge from an lot population. So that is the sense of the task force and there might be other ways of raising it.
Could we just say to capture what Barbie is saying. Because I agree with her that the secretary should do all this to ensure the support prior to moving toward with a project and I realize we just have that we -- lead and discussion. I don't want to be redundant. This would dispel the point of the before moving toward making a decision he will look at everything and make sure there is this support. So it is not concluding that there definitely will be such a study, not how we were swept out so that we don't have all of these repetitive phrases into the dense and tell prices. I leave that to others. The value of this is the fall, will work with patients every four years or two days are whether the proposal might end up actually been. And therefore that means you need better funding that somebody is the he about stretching court for two decades. Helen?
I think that is right. These are both correct point. These are two different ones. You don't want to do this if there is not popular support. On the other hand once you have watched until it it would be a waste of money to do it halfway. And so that it is really going to be launched then that is necessary that leadership by other secretary can continue to support this to make sure it is done in a way that really gives results that are worth doing instead of going halfway and saying we are will people we can stop now. And it is a loss to the study after all. So what is this issue of the word in short versus assess whether? I'm lip reading the lead it as is.
I think we need to be it as is. This is a very key point. If the secretary is going to burn coal or there has to be enough funding. Because he cannot make an initial investment of millions of dollars and just a short at the end but we are starting to see some of the benefits. So it is here and I think the entire document we don't want to say if he decides to do this -- this has to be an overarching recommendation that whatever you decide. We cannot have each individual recommendation with the violence violence.
Okay. I think we have a consensus on that and it will take a little bit of word slipping back at the home office. The third recommendation, again when you have seen in a previous iteration. Given the trends disciplinary nature which is the third different way we have expressed that and else we're in the document enter or malty and now the strand. That me simply wants to harmonize. Given the chance disciplinary nature of this [ indiscernible ] and management and multiple at it to us and non HHS agencies and with others takeovers. The essence of this recommendation is the first half but just simply says made which to consider and establish a highly cooperative model as opposed to a project like the human genome project that was run essentially by T NIH and B of be in a joint partnership or something was done to us strictly by one body. Any point on this one?
Yes, I'm not sure where to bring this up. So tell me if this, it belongs or appellee someone else. But this is very broad and I think that at some point perhaps and the overt recommendations and perhaps in the text it is worth stressing certain things that have emerged during the deliberations that could really facilitate such a project. But I'm getting to is the collaborative model with the DA. There are models out there and I think that the a is probably the best one. They offer tremendous advantages to doing much of the work of something like this with electronic medical records and lack of fragmentation and really good representation of minorities -- minorities a chapter. I think that it is worth highlighting in some way and our recommendations. And I don't know if in the spirit broad ones is the right place. There are certain avenues toward getting something like this done that has great promise to overcome some of the difficulties inherent in our health-care system at present obstacles. So again am not sure exactly where that should go but I wanted to make sure to get that out there so it is summer.
Is it your sense that this is to be an and recommendation as opposed to the tax that leads up?
One could even consider going halfway and say that there are specific models. These provide the promise of ceramic some of the obstacles of such a thing. So I don't know how far you must go in the overall recommendations because I think these are appropriately intended to be rather broad with kind of a 30,000-foot level. But I test drove that out there for consideration because as we deliberate did it seems to me that there are huge and advantages to certain specific collaboration's and in my mind mostly that the a model.
Okay. Other points?
Very minor but I was still wondering if we were trying to be polite and we used the word a wish and didn't use that elsewhere. We don't need to be that plight. The we should just consider saying the secretary should consider establishing. But there is a reason why we are being polite I'm all for it. I just thought I would agree with that.
I don't think that language was chosen for any particular reason. So we can certainly -- we are nothing if not polite.
I'm just wondering whether we should be referring to a highly cooperative model of project involvement as opposed to project management if we will be seen as trying to micromanage how the secretary proposes to manage the project if you will and there might be something to set for somebody being in charge, somebody rather than ride the rest of it being too diffuse that Altman the somebody is taking the lead on it. There are many agencies involved that we want to collaborate with.
I think the language of this came from looking at other large population studies around the world and how they have constructed their overall governance of those large population studies. Many of them have built a scientific advisory board were scientific governance board. Most of some kind of public consultation governance board and a number of them also have an export. So it sort of speaks to the implications of the government's and not the responsibility. So if you were to think of the scientific advisory board the River try to say that board should just be geneticist but should have a prior representation in the governance of the project.
I am not objecting to that point. I think we certainly want to educate their is a very broad spectrum of people that needs to be involved. I think in terms of the secretaries management style and the administration in general that there is very strong emphasis on accountability. And somebody should ultimately be in charge and should be ultimately accountable for the management of the project even though there are many partners in the project. Somebody in particular needs to be a responsible alternative.
I don't think the task force would disagree with that. But the intent of this language was not to suggest it would be a committee of five who would sit there without somebody being in charge.
Just to readdress we actually have talked about this before. And we don't know who actually will be in charge of this. And the kind of just want to be did open to find out who actually is going to be doing that.
That was clearly the intent. Okay. That is recommendation number three. Recommendation number four, the secretary in consultation with relevant HHS agencies should ensure that there are opportunities available to the general scientific community to be informed about the potential for such a project and present views about the feasibility of such a project and to present its views on the command of resources to such as the effort including whether there are benefits to leveraging existing courts and to provide [ indiscernible ] to the project resources and the death and samples collected within it. This covers a lot but the recommendation is as open as possible and make sure people than all those in the scientific community who would be interested at every step. That is my the vernacular tradition of what you hear as recommendations. Comments on this? Okay. And the final recommendation under research policy, recommendation number five which we have seen before, the secretary should require there are clear intellectual property policies in place for discoveries made using the data and samples to ensure public benefit. That was a point of emphasis that we had before and some public comment came in on that as well. That is to make sure those policies are there. In the Commons on this one? What a community. This is great. That is research policy. Then we have four recommendations under Richard logistics'. The first of these, the secretary should encourage product leadership and the site of the county to develop clear consistent definition of parameters for the classification of the predicted sample population to ensure diversity in the proper representation and the population to be steady. I don't think this is controversial for anyone. As I said they have seen this before. Okay. Hearing no, it's we go on to a recommendation to. The secretary should seek input from the public as well as clinician's on identifying sub populaces for recruitment and on approaching, educating and bowling various sub populations. Project organizers could be [ indiscernible ]. Okay. This is number two.
I'd just wonder whether just to capture some of the test letter on that we get to end the public consultation with that this should say something like as part of their recruitment and an on the assessment and strategy so that it is not just seen as a strategic approach, but it really is truly an engagement portion as well. Assessment and an on the strategy.
At it. Anything else on this one? Okay. Recommendation number 300 Research logistics' allow the secretary in consultation with related agencies -- we should again harmonize how we say the same thing three or four different ways and how we refer to the Secretary and his agencies. We should refined methods for collecting and analyzing environmental this bill behavior and social factors influencing health and ensure that researchers are devoted to developing the tools to invalidate existing methods and to improve assessments of the environment. Michael?
I was looking to the section before and it talks about other government agencies. In this section here it talks about related agencies but really doesn't spell out which other agencies should be considered. I think EPA would be critical, OSHA, USDA, even this from a standpoint of working out standards for data collection. Just something to consider, I just think that is lacking in the document.
So not necessarily in the recommendation itself, but in the text you want us to be more explicit?
Perhaps even in the recommendation, but certainly in the text.
I think we have to be careful that we don't appear to be an all-inclusive list less we forget one particular group which could be the danger. The question is whether the secretary needs help and coming up with a list or whether that would --
And discernible.
Our intent was to be as open and expansive as possible rather than restricting him to say just did this with NIH were one other group or to groups or something of that sort. Other comments here?
Perhaps we just want to be clear that it is not limited to HHS. You should consult with non HHS agencies as well like the EPA.
Could point. We use that actual parenthetical on one of the other was referring to both HHS and not a digest. That is a good point. Other comments? Okay. That was number three. And number four, the secretary should encourage project leadership to consult with health-care providers and organized to develop uniform and perches for developing clinical information to be gathered of the course of the proper coding the use of electronic of markets.
I think this is a good one as well ahead well stated. I think that we may be able to with a slightly to take better advantage of the discussion that happened yesterday where we spent a the bit of energy on the secretary's initiative regarding the inner upper ability of health and condition technology advances. I to know with interest the body of the report does speak to it, but the way it goes the way we describe it was anyway -- anybody doing this work but to connect to the initiative and one of the things that we might want to say to the Secretary is that the people designing the system ought to be thinking about uses such as this is by the time we get to that point so much of the HI T in dropper ability around collecting this data we will have already been -- the trend we will have gone way down the tracks. So just as a matter of so the I am suggesting out in the recommendation but the body of the report somewhere where we urge the Secretary to have his people be thinking about these utilities as they design the health information and property.
Okay. Other points from anyone else? Okay. That is research and logistics. Real Tory and ethical considerations? The secretary should convene a working group ever presented from the Office of Human Resource protections. The FDA and other relevant agencies to develop a set of best practices and standard operating procedures including review boards that oversee the study. Public input on policies and procedures should be sought. This working group will be charged with insuring all research side [ indiscernible ]. And patient safety. Comments?
I apologize for these -- raising these 11th-hour concerns, but I do have a and a -- a number of the recommendations I would like to raise. The first recommendation really does get at the issues raised within the section about ensuring the privacy and confidentiality of the information as well as protection of individuals participating in the study. And clearly we want to highlight this call but in looking at this recommendation now in context but the public comment as well my -- I have two major concerns and will suggest some edits. One is that in terms of this working group to develop a set of recommended best practices and standard operating procedures the groups that are identified for this working group already have very clear boss and regulations that the agencies have promulgated in their respective areas. And to ask them then to develop standard operating procedures and recommended best practices sort of puts them in this was I regulatory review -- note that could be complex in terms of, number one, 40 to do this and number two crossing over a number of areas. And so what I would like to suggest there is rather than having this work group of HHS agencies actually develop standard operating procedures to characterize their role instead as to provide technical assistance and legal requirements regarding protection of research subjects. I would sub to help the commission for medical privacy and patient safety. So the rule is really one of technical assistance rather than actually promulgating a set of guidance or operating procedures that then could become binding and get us into a regulatory framework. My second major comment this with this last Centex -- this working group would be charged with ensuring that all research have all but a site by implementing the regulations established to protect research subjects, medical privacy and patient safety. I would like to recommend a more generic statement that just acknowledges that the individual 88S and other federal agencies would continue their enforcement and oversight responsibilities to ensure that all research sides involved in the project are implementing and then the rest of the sentence. Because I know these are pretty detailed suggested edits. I don't know whether we are at a breaking point and a might be good for me to type these up and people can see them on the screen.
Well, let's -- I'm less worried about the specific words the thing than the general comments have want to make sure the community has a sense of what you are suggesting and whether there is general agreement.
I think actually the task force is very to leverage in suggesting that the Department of Health and Human Services and the appropriate offices that have the regulatory and oversight responsibility for these functions sit down and create policy in a very deliberate way. And the reason the task force went in that direction is because many many many of the public comments were around a number of issues of privacy and confidentiality and protection of human subjects and ensuring that data and information would not be made available to other third parties in government or outside government. It was really in response to the concerns that until there was an assurance of protection and that that was well defined it would be difficult to put it broad public support for such a product. And sir really it was deliberate on the part of the task force to ask each HS to establish a very deliberate policy to address some of those questions. Interpreting an existing rag --
There are a couple of red lights down the line.
Just on the perspective of office of Hewitt resource projection I do share some of the concern that Rahman raised. I agree that best practices, as of piece, there might be different word for that like guidance and recommendations could be developed. We would be particularly concerned about the last. I don't think the less sense in terms of a charge of this work group is feasible to the implement. The work group will be relatively small and have representatives. They will be able to ensure that hundreds of Massachusetts are comply with the various regulations that would apply. Even more broadly the Office of Research protection, we are not capable to ensure that all tickets. We can facilitate and give guidance, but where insurance comes protectively that people will -- and is sure that would happen, that rests with the sponsors and is not focused on our regulatory agency. And we would propose significantly modify or even removing that last sentence.
That is very helpful. This is why be have a committee to get this kind of input. Some of that I don't think was the task force's intention to argue any differently than you did. So as inappropriate as it sounds we would say you come up with another word. So during the break -- and I don't think we are at the bridge yet, but during the break shari, Robyn, Sue and is that Michael? Get together and sort of craft better language that would meet the intent of the task force in considering the public comments and then also be agreeable to your agencies. An FDA as well. Other comments, but then my intent would be to table this recommendation and come back to it after the break. Martin down the line.
Just a point of that fourth line. Do you need to limit this just to HHS or should it to say in all relevant agencies. Perhaps you would want the Census Bureau to be part of that and maybe other agencies.
I'm sure we don't intend to limit the secretary so we could use or same language of HHS and not a to a desperate.
Are even just take out a change as a point to other Bell the agency so it is limited at least. But away.
Kevin?
Just a quick question for Michael. I think he raised a very good point. My question is when you say, the responsibility of something like this is what the sponsor, who is the sponsor? Who would you see as the sponsor for this sort of large population study? It is the government -- this is question. Who would you see then as the responsible group or a potential want to give.
The price possibility was that the authority to engage in research. So a secondary the possibility was that the sponsor. So if it is out-H Bruce passed the destiny of this they would have responsibility for ensuring the IRP reviews. They would also have some responsibility for insuring that.
Ahead. Anke. Anything else on this one? We will come back to it after the break once we have a few modifications to look at.
The next recommendation is a new one based on the public comments which is that an independent ethics committee should be established to serve in an advisory capacity to the IRB and capacity management. This probably does require some discussion and general consensus because it is brand-new based on public comments. Any comments?
The question would be independent of what?
Independence of -- that is actually independent of project management but in an advisory to project management. So it wouldn't be simply the product managers who would be doing this. You would have the air of independence as an ethics committee that would oversee --
So those of you that are familiar with NIH project now in terms of how you get into ethics, I'm not sure I have enough detailed knowledge to know, isn't there an independent ethics function that advises the conduct of these are there any ethics books to give?
They have councils, but there is no over ethics group.
And you guys in terms of -- what is the ethics thing to Kia for Genetics?
It looks like a cow. Does Elsie do this?
Speak. There we go. They're is a difference between what institutes have in place and what individual products have in place. And so the Institute has lots of different kinds of advisers including advisers with different sets over the years in different ways to our portfolio. But that is different than being advisers to a specific research endeavor. Set this is not calling for -- said this before I was concerned about this and should have it done in terms of my question, as this calling for a redundant level of bureaucracy and is it a statement that says an existing ethics activities is not sufficiently independent so this becomes a big slap in the face of existing infrastructure? And what I think I'm hearing here is that such a thing does not necessarily exist for A particular project which has not been created. So when you create the product you create an independent ethics activity for it and that is the normal way.
The intent is also to be independent of the IRB. There is an IRP that is charged with making those kinds of decisions in terms of the actual substance of the projects and how that will operate. But then this recommendation is that there is a group independent of that one which is looking down on top of the deliberations of the Harpy and making recommendations.
What would be the -- so to, I'm sorry. So again I think all rational people would be in favor of having great ethical oversight. So that issue here is if you have an overarching Ethics Committee backing down on the IR be in an advisory capacity it sounds like it doesn't have to use. The real action is still in the IRT. So what would this group other than not cannot and look them --
Well, you might ask that of the ethics boards that sit in each hospital that help clinicians and management make decisions when bodies are in conflict about individual patient care. And this board was really seen once again in response to public comment without concern and particular about the informed consent process and the on going informed consent process. And what I mean by that, there were many many questions raised about how to back up and review informed consent. Informed consent is intended to be specific and to have knowledge about what it is you were consenting to, whether it is research were patient care. However, we know that over time additional research questions may be raised. These are very valid, accepting and the scientific community will want to pursue. One of the envisioned functions for the epic board is to be able to overtime assess those questions and determine whether the initial consent is a tremendous ability for the posted 52 projects or whether they be consent process may be required overtime. It is also envisioned that in the initial informed consent process that they develop a statement that explains how that is to be handled so that the principle of transparency is embodied in the decision making process for consent. There were also a lot of other issues outside of informed consent that touch on some of the other issues. This is how it would be eased but internally within the department and externally. So there are a number of issues in the design and ongoing oversight of the project that in response to public comments was felt that it was rate partly focused and problem based ethics board and should be employed to do with these issues. It is not a --
And you obviously don't believe and at the from what you just said that this would not weaken your normal function of the RB. It doesn't create a competitor to the IRT. It doesn't create a parent of the IRB.
What we find in the HA is that we have up exports in each of our hospitals. We have I Arby's that the majority of our hospitals as well. We also have other ethics functions. What we find is there is often a need when the issues cannot be resolved within those parties that they feel like additional input needs to be brought to bear. There is to be a place for those questions to go. And as a national office we manage those sorts of questions. It is similar ideas. There is nothing in there that says it has to be whenever. Maybe that such a board would be constructed and would meet our very rarely in only be called in to deal with specific questions. It is not intended to be, as you say, an additional layer of bureaucracy. It is an opportunity for to Lipper to discussion of competing values and issues.
I like that and. My concern is a have province tons of not having a redundant layers of bureaucracy that cost more money and gives work and takes away resources from doing science. Secondly my concern was that it not be in fact or appearance we can be legitimate, infrastructure of ethical scientific review. And you are saying that this would do not there and that it would be in place and be there to serve if needed and it was needed you would have to create a de novo on the fly. And I think that makes sense.
I think there were some initial design questions that this board would be helpful in informing the IRT initially and the governor's body. Then there is an ongoing function to have more of an on call basis as needed.
This recommendation is remarkable for its brevity, but as I'm sure you recall when you read the full document their is a long list of particular functions that this tax committee would undertake and I think they are different from what standard I RB would do, even a specific hour be designed for this project. Michael?
My question would be, is this scalable? In the event that the IRP -- if this is a two or 3 million person study there might be several I Arby's that are involved. And the way the product might be set up is that grants would be sent out to bury sponsors as Michael was talking about to read certain aspects of the research and each group would have its own I RP. Is this intended to be one ethics group that oversees all of those?
I don't think the task force -- that is a level of detail that one cannot address until one knows how a project is approved and how it is set up. Some have argued for a central I RB. So regardless of how many millions there would be a central I RB that would deal with it rather than dispersed by Arby's, but we are even discussing that particular question.
I just want to make sure it is something actually workable in case different scenarios occurred than what the researchers conduct.
I think it would be to have the secretary in his wisdom felt that we needed three independent ethics committees instead of one that wouldn't be inconsistent with this recommendation if it needed to be that because of added complexities. I don't think at least for me that it would be an issue. That is a decision for him and product management to make.
With these recommendations and the previous recommendations I have that issue with consistency. Here we talk about IRP. In the previous we have an eye out be with the as at the end. The FDA is that are be telling them they need to have only one eye of the versus in the previous ticket is to be consistent throughout the document where we have an open ended blind of the distance so I RB, but some think they need to decide.
That is useful. The key.
Maybe the word of ethics committee is a problem, but I don't have a better one in mind. And I think of this community at its ties it a lot and it is just an oversight committee, but it covers all of the else the kinds of issues. But I don't want to call that an else the community either. That just sounds wrong. In the text describes it more accurately than one of the test it does that is outside of the party is looking at issues like Doctor but to our attention yesterday. It is sort of more -- less policy type of issues with more social impact. And I would see this community as looking at the big picture of what is happening with the result of this study, our recruitment strategies recapturing people and not as following the eye of the requirements but the larger broader global issues that the public commentary is raising that this type of study has new issues addressed a large regular genetics.
I think there is an opportunity before to cut not that there is anything wrong with brevity, but this is to pre. And it could read and and the Ethics Committee should be established to and served as advisory. So actually give its function in a brief phrase that would take the previous page where it has gone through in some detail and to still get down to a phrase that is meaningful in the context of a recommendation to it that it isn't just said absent any clarity whatsoever. So I think we can --
They're is a group that has several institutions with their own I RB for one particular project, but they also have an overall musher I not be to think sure everybody follows the same will and then from that point on they have an ethics committee above that to kind of talk over. And when we first drafted this, that is why I had envisioned this is what would go on because this will be a large project with many many institutions. They will have their own I RB and they're own ethics board, but overall they need to come together with and even ground somewhere so that they can kind of work together and share samples and stuff like that.
Other points on this recommendation? So I'm hearing support for the general concept of this recommendation and perhaps some of the language can be improved and made consistent with the other recommendations, but I'm not hearing anyone argue against the need for such a community. Okay. Recommendation number three, under regulatory and ethical considerations pratique the ships of systematically and regularly seek the input of studies regarding consent and regulations for enhancing protection and ensuring that the proper projections are in place and are being consistently implemented. Comments? This is not a new one. We have seen this before in the previous draft. Again. And the final recommendation under regulatory and at considerations is project leadership should develop guidance on the use of data and samples to promote the ethical use of the epidemiological data. This data should be made available to subject.
One quick suggestion here, and that this to rather than use the word promote, use the word inshore given the critical aspect of ethical use, but also to the insert and ensure that legal and ethical use of clinical and epidemiological data and specimens.
I would actually argue against using the word guidance which has another meeting in another world and is not binding.
Do you have a substitute?
Maybe something like buhls, I don't know. Something that is a bit more binding. Guidance sounds like a suggestion.
One thing that we could do is just say protect the ship shall endure the legal and ethical use of data and samples.
Its policies on bread and guidance?
The Home Office can figure out a better word than guidance, but that is a good point. The key.
You may want to consider the protocol -- per call.
Other points on this recommendation to give.
Okay. Then public health social and economical applications, there are two recommendations here. The first one which is not. Apparently, the secretary and project leadership systematically and regularly into a project financed with other emerging data from other types of studies and regularly disseminate the committed knowledge base with clear descriptions of the possible clinical implications of the results and limitations of the debt that tries ability and public health implications. This information should be tailored to meet the information each of the public and health care providers and public of community to use it rate information for the benefit of the population's health. Project resources should be sufficient to the integration, dissemination and transmission a to these necessary to maximize the public health impact. That is a large overreaching recommendation that covers a number of things. That it is mostly to make sure that the information is disseminated and then used wisely and as broad as possible a way for the good of the public. That is the short version of what is here. Other comments?
The part about the possible clinical implications gives me some pause. There will be incredibly nascent an incredibly contentious and conflicting. I have some concerns about in a way requiring that aspect of it. Because of be are there by necessity with the preliminary nature they are released on a regular basis and I have some concerns about that.
Do you have an alternative way of phrasing that?
Yes, leaving it out. Seriously I think that dissemination and release of data is very important. I think that the clinical implications will be something that is picked apart immediately by ever on his receiving it. And I'm ticked not sure how feasible it is to have that. I'm throwing that out there. I understand the concern and the desire to highlight the clinical implications, but man, there will be contentious. Look at how contentious of become a complication that gets, it is.
Took a. Emily.
I would just urge you to think about it in the context of the Women's Health study and the interim results which were published and resulted in quite a substantial change in medical practice regarding hormone replacement therapy of heart disease. So I think there is an obligation, and ethical obligation to publish interim results at the point where you have something to say. And I think your issue is, do you publish interim result before you really have something --
Right. And I think you bring up an important point. I think that particular example illustrates one end of the spectrum. When results are so clinically compelling than they need to be highlighted said. So be saying something like descriptions of the clinical implications when they have reached in double that contributes to our clinical knowledge -- in other words you look at the human genome project. You have a lot of release of a lot of data, and that is a really good thing. That is going to go on and then every once in awhile there will be things with clinical applications that should be highlighted. So maybe some modifiers their that clinical occasions when the date that specifically addresses such disease or something like that.
First London and then Kevin.
Yes, I think that if you read further into the sentence you get to the point that the critical of petitions are going to be discussed. We know they are with everything that is found. The point of this is to look at the limitations of the data and to non stability and the cycle and help applications. Said the point is exactly that to be sure and look at the clinical implications in the context of what the data actually can show.
Maybe the word balance can be in there. Given? I was thinking since we do have to cut I just realized this now. The of clinical applications was there. We have the possible clinical implications of the piece of and the limitations of the data to cut the channelize the petitions. So maybe we can say and said something about pertinent or relevant clinical public health implications too attractive avoid what Tim was raising as a possibility of just to pick something out there. This just adds fuel to the fire and not necessarily in nine in England. Try and throw in some phrase that says pertinent or relevant or something like that.
We will come back to you. Scott, did I see your hand up?
In discernible.
You could the that the second critical and simply the public health implications that that would be fun. Because competition is strong so that the report will be given out. And one of the reasons we have that this that one of the public comments addressed that. They wanted to have it to disseminate out to the public. When get data is being released and the patient wants to know what is going on.
Elizabeth?
Maybe I am a minimalist, but I don't think we need to tell the Secretary exactly how to release the information. I think he could just say to cement the committees did not base in a manner to benefit the population's health. And be the best of it.
Some of the debate here will not be resolved by the study. Most of the findings we will have are not having testing. I think [ indiscernible ] specially designed to test for the about this is true or not. So people are always understanding the Celts of the study and applications. So there is almost time to be to direct it. The most approach is better. I agree prepared to answer some of that. We are back to you.
That is a great point. We want to avoid the inherent misleading that can result from of the original studies. I like the most.
That is called consensus building. The next recommendation of the Public Health with social and economic is a new one. They should establish an independent standing committee for the duration of the project to per radically assessed for assistance an emerging social and economic implications of this initiative with special attention to health disparities. The critics insist that consists of individuals the committees of expertise with passion and Community advocacy. The community would routinely seek public input on the implications of the product results and report its findings. A previous version of this was in the draft report. It is the addition of economic which is really new here and that is why that is highlighted on the screen. Comments on this one? Okay. We used it all up on the previous one. So that this -- we have two more to go. It is my intent with your forbearance were being a couple of minutes over the allotted break time. The will to the last two recommendations under public engagement. That is a good time for the break and it will come back and revisit the one recommendation we said we would revisit and then move on with for the discussion from there. So under public engagement there are two recommendations that the first one being desperate the publish one is to participate in a large publicity should be assessed before embarking on such an expensive endeavor. Willingness could be assessed her opinion polls our quest for comments posted on agency Web sites and other proven lesson. Such an assessment could be made in advance of a funding system. Comments? Elizabeth?
The first and last sentence is perhaps is a bit redundant.
As I was reading it that the did occur to me.
So combine those two?
I think the sense of the task force was in advance of funding and an advance of starting or perhaps to separable advance, but Bonn the less they could be merged to be sentenced to make it rich better. Other comments on this? Okay. And the second recommendation under public engagement, if a decision is made to proceed with a project it will be important to ensure public engagement occurs throughout all aspects of the research process from conceptualization through design planning and implementation of conduct and data analysis and reporting. Public engagement also will be important and apply the knowledge gained by the Research and then addressing its implications. The secretary should insure that sufficient credit resources are dedicated to consultation activities before and throughout the duration of the project. Michael?
What about following up after the project is over as far as how the recommendations or the changes or the data on our ongoing basis afterwards.
As part of public and does that were part of a separate question to keep.
Out, as part of public engagements from the standpoint of after the study is over and the reports are out, people were stunned to call her recommendations over the years. It is important to find out the actual metrics were some mentors of if this is really making an effect on people's lives. If they are actually using and intention.
So I'm seeing that as assessments of the value of the project, but I am last seen that as part of public engagement. That is actually an assessment on whether the incidence of diabetes is actually decrease some how or we have better management of diabetes because we have done this project. And unless I am missing your specific point -- and.
I think I have a sense of what is being asked. This is just party at the point. The whole idea when you do collaborative work and involved a small engagement is that every state of cooperation from the actual implementation to the follow-up which is what we discussed, you include that level -- you maintain that level of get in. So everyone else is involved in assessing things like efficacy and outcomes of that sort of thing. But also we are adding the element of those that are involved or being basically -- the whole principle that you are experienced and to what is involved in the decisionmaking process. You and the follow-up you also engaged. That is what -- if that is what the ballpark of you are asking to the.
Yes, and also the people and the study, it would be important to find out what impact it had on their lives, moving forward after the study is over with. We heard the lady talk about the issues of the cost jazzing Jewish population yesterday and it would be important to assess if this had any sort of negative or positive affect on the study participants.
I see the point. Jussive?
I think we are engaged to the point of where if this is done, that is where we are. But in terms of the other, as you said, second part to worsen and face thing, that this kind of what this would call but for the way I see it. We are at our point in saying that we should have participation of following it up to that point. But the decision is made from before, that this other thing. That is another level of consideration. So we just need baggage that expresses what we need but follow-up and for the two parts of this which should be easy enough for the home office to add. Elizabeth?
We will have a no most alternative here.
You think you just need to have a recommendation by have been other ones and you could do that with a little restructuring of the last of. I don't think we need the pieces, but a recommendation.
And you will help us with that?
Of course.
We paid by the word. Any other comments on this recommendation to? Okay. It's terrific. We have consensus on 17 with some suggestions for changing of language. And we have one that we can consider after the break and Mr. Chairman, back to you.
Well, let's see now. How long a brick do you want? Do you want 10 minutes or 15 minutes? Fifteen? All right. So 20 after the hour. So we will see you at 20 after. Thank you all.
I forgot to bring something to your attention. It is the greatest thing since sliced bread. When so here is the deal. You may have taken it for granted it was so good, but if you noticed in the report each one of them have something called [ indiscernible ]. Did you notice? If you didn't, you should have and I was supposed to tell in this in the beginning. It shows you everything. This is like copyrights by double stuff. You came up with this?
Let me clarify, this was in response to a specific request from Jim Adams.
But I didn't call them [ indiscernible ].
No, you didn't. That goes to bed.
Anyway, we will keep this format because I think it is really terrific. Gives you the key questions to consider. Effected a good job and the want to thank her. Would.
Okay. The key. So we have two things to deal with at this point quickly. First is the revised recommendation number one by this crackerjack legal team of Robyn, Sue, sherry and Michael. So this recommendation now reached the secretary should convene a working group of representatives from the Office of Human Resource Protection Food and Drug Administration and other relevant agencies to address issues and questions raised by the public and to provide technical assistance and guidance to research sites on legal requirements on protecting a research subjects, help information and public and private sector. Comments? So the best of both worlds, it creates the working group and allows them to provide input and guidance, but without stepping on the legal issues that were misstated last time.
[ indiscernible ]
I was just wondering about whether in the press to address questions raised by the public you might want to say describe the nature of the issues and questions that this group would address versus any other. I don't expect that they would address questions about the design of the study or the scientific goals and so forth. The questions that would be put to this working group from the public would be those pertaining to --
I read it at as to all those with all due respect there were three lawyers to write this. The phrase at the end regarding protection of research subjects, all information and public products Safety I read as modifying everything that appeared above which include issues and questions.
That was certainly the intent, but we will defer to the words with is to make that clear if need be.
Other comments? Kevin?
Just a question of clarification. Here is the focus seeming to be at the end they're on the requirements regarding protection. So I presume that is intentional and we don't want that at ethical and legal requirements because that would be outside the purview of this group? Okay. Just want to check.
Just for clarification, how does the committee in this in the mechanism of public input for this working group?
The initial public input was this public comment. A lot of the issues and questions that need to be addressed were raised during the public. The first task would be Ted sort through those, at and determine whether which of those are the questions that need to be injured. After that there are a variety of public and different mechanisms that the establishment could be drawn on to draw additional feedback and input. That the process of public engagements issues will continue to be raised that need to get somewhere for this kind of assessment.
Other you could imagine that the issues and questions could be raised from anyone, not just the public. They could be raised by project management and project participants as well as subject themselves. Other comments? Okay. Thank you very much to the team of three there. That was terrific. Another suggestion that came up during the break rooms at McLean and ask you to explain it better than I ever could.
I was stuck reading the public, and getting the feeling that there is a lot of concern from the public on behalf of ethical oversights and protection. And one of the things that I'm familiar with in some of the military research we do on protectors and hon. populations is appointing a button to speak for that group who may not be appealed to articulate their concerns were their position adequately. And there might be a role for that on some level, some of our our king of all dealing with particular hon. populations that this study will address. And I just thought that might be -- I wasn't sure how that would fit into what we have discussed so far. We have Ethics Committee's, and overarching at this community that might be independent. And I was just wondering what the talks were on the ombudsman type of element to this.
Comments or reactions?
It is an interesting question whether an individual needs to be appointed Perce or whether one of the two committees that have not been recommended the explicitly given that role because there is the Ethics Committee and then there is the committee that has been recommended for the social and economic issues. And whether in the consideration of the formation of either of us to to ensure that the functionality of an ombudsman person is involved -- explicitly described.
I think the ethics committee would have its primary allegiance to the Ethics and an ombudsman would have their primary allegiance -- and it may not be an individual, but maybe a group would have its primary allegiance to be a spokesperson for those research subjects. So I don't think it is a subtle difference. I think it is a real primaries differentiation.
Other comments or reactions, Barbara?
One place to put an end without an absolute certainty it would be a useful role, but one place to put it and would be in the description or text of that social and legal economic policy group. So this is to put in and consider such as the consider all of these pre put it as an example of one of the functions of that.
Put it in the text to keep.
In the text.
Is anyone opposing the inclusion of that as one of the possible roles this community could play? Of we are doing is providing examples of the kinds of functions. We are not trying to prescribe -- not that we could anyway, the action a secretary might take. Okay. Scott, thank you for raising that. So here are the recommendations, at this point there are a number of questions which were listed and are on the slide. I think we have touched on most of these as we have gone through. I think it is really the bottom two bullets on this. But there additional areas that must be addressed that somehow we have missed now that we have run the gamut of everything in the report? Have we missed something? And if yes let's address that now. If no, then we can move on. We can spend the time about what actually our conclusion is given all of this so that we can -- because that is a section of the report that am sure will be receiving more attention word for word than any of the other areas. So first are there areas that we have messed either from what people have read about the public comments were just in thinking this through? Okay. I think that is a reflection of the fact we have been mulling this over for the better part of a couple years now. Said then the question comes to the conclusion -- the one issue that I think to come back to the discussion we had at the beginning speaks to the town of the report. So I think as we discussed previously we do want to appear neutral. They want to actually be neutral and have the town and the language sounds that way. On the other hand as not a ticket back there certainly is an opportunity to a phrase that in such a way that says explicitly that we acknowledge that there as substantial potential benefit from such a study. This is for the improvement of health of the American public, and that therefore the following issues need to be addressed and tackled prior to deciding whether in fact such a project can be undertaken and and what way. The alternative is to be completely neutral even in the conclusion and simply to set it up to half a per hour and a talk sake of weaker told to suggest some issues. Here are some issues and here are some potential mechanisms and best of luck to you, Mr. Secretary. I'm going to open that wide open to the community. I think this remains the one issue that we have to sell as a committee in order to sell as a consensus on what the town at the conclusion should be so we can be of greatest help to the Secretary and yet what we have been doing for the better part of two years. Comments? Jussive?
I would just make the comment that I think it is important that the town itself be consistent with the overarching recommendation that we made which to me does set the town for the rest of the report, and secondly it be a very distinct. Let me just back up. What I mean by some to is that the concluding remarks themselves do not have to be extensive. They just should reflect or even summarize even briefly what we have there. But I do think importunate it -- the Sun should be consistent with the overarching recommendation because that was done after review of everything else. And I do not think it is inconsistent with what we have discussed or come up with so far. That is just a comment.
Other comments?
Just to try to climb back up on the bridge that Reed pushed me off and then said that jobs. Getting back to what the press to do in the three things we identified was outlined approaches that could be used and recommend mechanisms I don't it is inappropriate to say we see this process in and of itself of being of great benefit. I don't know how the process will eventually work out, but the process and an of itself is something. The process of doing what we did and then the secretary going forward and doing a brisk evaluation. So in other words, if there is a positive to really be emphasized here to say what we are doing is a good thing and what we ask the Secretary to do, we think is obviously a good thing. That is in and of itself without contesting that on any particular conclusion.
Is that better?
Can I state on the bridge now to give.
Other comments.
Eye test want to make sure the conclusion shows that we are really supportive of a careful public consideration of the participation and cost of this project in the overall scope of our current health care system and may be failing health care system so that it is very supportive of the Secretary meeting to do a lot more. This is so that it is not a for or against the project. It is for consultation foreshore.
Other comments? Alan, do you have a reaction that you wish to share with us?
I don't want to take up the committee's time by saying the same thing, but I would say the same thing I said before. And I think I just have to say it again yourself. I do think we ought to come to some kind of -- I agree with what other people are saying and with Kevin's point that even if there is the decision not to go forward that the process of looking into that in and of itself is worthwhile. This will say things that will be printed not just to a large population, but stuff that is printed to a lot of health research except for that is worthwhile for the contract at the highest level to be thinking about. So I actually agree with that. At the same time I do think in the conclusion we should have a brief statement that the potential benefits of this to the health of the American people are significant and unique. And that is what makes it worth spending the amount of time and money it would cost to do this kind of thought. So I guess I would like to -- a night to have a treasury of the community, but they may want to decide whether or not up and down it wants to have that in there.
Yes, because you are not saying that we are supporting the concept of a pot population study. It is simply that we are supporting an extensive and comprehensive analysis of the issues.
And the reason we do that is because we think it has potential and I would include potential and the. Potential significant benefit.
Okay. Barbara?
I don't disagree with that, but if I were to include that cause then I would have to attend to the other side at me that is feeling a bit sub test. The lessons we learned from the human genome diversity Project. And the history of other large databases and nationally that have had issues of confidentiality and privacy concerns relief rise to the top and put a reason for slimming down and being prepared careful about this. But then we get into this raises of there are benefits but risks. So that is why I keep coming down to the idea of neutral because I keep seeing them pretty neutral. I don't personally feel the uniqueness of this is so much bigger than the potential challenges of it. But luckily I am not the secretary and I don't have to make that decision.
I guess I would say I see this distinct and different from the diversity Project. Some issues may be the same, but this whole process the report is suggesting, is that process and many other countries for instance have lacked and is intended the recent they have gone to some of the -- I was going to say ethical less to say quite my that they have gone into. I think we are even [ indiscernible ].
Yes, I tend to agree with what Barbara said in the sense that I am agnostic about whether this is -- the benefits will of way --
Kathryn can help you with that.
Exactly.
But it will cost you.
Internally. I think that given our charge I think maintaining neutrality is highly inappropriate. I don't think that prohibits us from saying that it is possible this will reap great benefits, but I think if we say that we necessarily have to say on the other hand it could be a waste of a lot of money. So my tendency and is to avoid those if on one hand and the other by maintaining that neutrality that I think was very nicely summarized in the overarching statement.
Just to give an alternative you to that however, if we don't write the sentence that says it has great potential, but it also raises a number of issues that require exploration and therefore -- if we don't read that phrase someone else will write that for is. And therefore it is in our best interest to write what we really mean. If we really mean in terms of concessions from the committee that there are both significant potential benefits and a number of troubling issues that require in depth analysis, then that is what we believe. It can be written in a way that is balanced, but if we don't write that, my concern is a whole bunch of other people will be writing that and you have no idea how that will come out. That is the difficulty with appearing neutral and trying to be completely neutral, others will then decide how they want to describe what you are being. I think it can still be written and has balanced a way as possible because I do think there are nuances here and depending on how analysis of the issues comes out any one of us might then say, great. Fantastic project. Let's go do it or no way. Notwithstanding the great potential it is just not or these other issues, but that is point to take a fall in depth analysis that we help the secretary would support. So that is just a different point of view.
I suppose the -- complete support that. Again, I think Barbara summed it up like you to it, that if we avoid that plot neutral language and we have to put an --
I think that is --
Certainly doable.
Comments? I find it remarkable that there are no other comments. Mr. Chairman, what kind of a conclusion would you like us to articulate? This is report of the community and is a report of the community after two years of intensive work. Are you wishing a sort of the community reached five conclusions here they are or are you looking for a general statement of the conclusion according to the 18 recommendations?
I think at this point it is whether or not we are prepared for this to go out to the secretary. And so I think it really is -- the issue is, is the community satisfied that you have reviewed these issues enough that you understand the consensus in terms of any modifications we have made? And basically it is now time to put a bow on this and send this to the secretary. I would urge you, unless you have any particular major our readiness which did not come out at the end of reviewing that you authorized your subcommittee to present this in final typed nice form and it goes out to the Secretary for his review. And if you have any and readiness that you want to be concerned about that causes you not to be able to have that report go to the Secretary of speak up as to why that is.
Is there anyone who feels they are not ready to essentially vote on approval or non approval of the final report? And if so why? Joseph?
I'm sorry, I apologize this will be a little out of order, but my question is about the conclusion. Are you visiting that the conclusion will be written after this particular vote you are asking? To we need to see that conclusion?
This, the conclusion would come to the full committee. The whole file report will be, but you are not expecting to see enterprises and the first 60 pages but the conclusion page will be de Mello and you will see it for the first time and we will have to do that as part of the process of refinements an ultimate approval essentially buy him out. Okay. Thank you. But I think what read is calling for, what we will send call for is a statement that says, subject to that we are ready to say this report is done, essentially, with a few minor tweaks that the task force and the home office will take care of. And then you are prepared to see it as the final report.
So let's just make sure we are absolutely clear here. Ito is right on the money in terms of this. As far as we are concerned, you have approved a report that is going to the secretary. The thing you have not seen as this last little bit of conclusion language which staff is prepared home office forever known is prepared to turn around and the next couple of weeks. So the assumption -- and I need to be real clear in terms of the EPA this. Once that conclusion is done everyone gets a copy of this. It is not for been revoked, read anything. It is to look at it. I assume that somebody sees something overwhelmingly obnoxious that is completely different from your understanding of what we agree to end at a conclusion. You have the opportunity to call me or hot and we will job and get involved, but as far as we are concerned you are getting the courtesy of taking a look at the final. But you approve it at this meeting if you in fact do so in the next minute and it goes out the door. Said the secretary will get this report on or about Christmas. January. All right. So you have to make sure it is polished and looks nice and has no typos and somewhat. The secretary gets this report on about January 1 which means you don't get to have another meeting about this, not another giant conference call not mother died talk about nothing. That is where we are. A turn it back to you to bring this book to a closure -- I guess I have to do that.
That's your job.
You did such a good job. That the put a motion on the table for you. The motion for you to vote on -- who gets to vote on this?
Members.
Members. You started a lot yesterday, but not today. The members vote to accept the report and recommendations as described and discussed at this meeting. Let's stop there. I will get to plan to any minute. So you are voting now to accept the report as discussed and agreed last and consensus reached on each point at this meeting. All those in favor of that, accepting the report and the recommendations say I. Anybody opposed? Some. Good. Secondly, second is that we approve because Ford this report to the Secretary to include a conclusion that will be shown to you in the next two weeks, and if there is any major up sadness about something in that conclusion, you will modify Hunt, Willard or reject immediately. Otherwise the vote is that this is a concluded a report that is being transmitted to the Secretary on or before or about January 1. All in favor? Anybody engaged? You are terrific. Hunt he did a fantastic job. The community did a fan tested job.
Just a clarification, if that were to occur that somebody were to get ahold of you and I thought, what is the process at that point?
We will first of all look at it and agonize over it and decide whether or not it is deserving to go back and let people take a look. Of respect for the consensus process. Okay. We are now at the next stage where -- by the way, I am supposed to remind you all about what she, whenever it is. We will keep working for a minute because it is 12:00 now. A lot is at 12:30 p.m. Do we have the public people here? We have won public comment. Terrific. Where? Hi, man. David, come on up. I have to say this because it is official, and I have to sound scenarists when I do it. One of our critical functions is to serve as a public forum on the broad range of health and human issues brought. And no playing around, we do pretty by you the input we received from the public. It is very important to us and so we do set aside time each day to hear from members of the public and we welcome and appreciate the views they share with us. And so we are happy that David Angelo -- did I say that right?
Better than last, modulo.
I haven't got it right this hall meeting.
It was a CLA, and based on the discussions yesterday I'm sure you will have some very interesting comments to make today.
I hope so. Thank you very much.
Five minutes, but I'm pretty tough.
Thank you very much. I'm done with the American critical ever trust association. We represent local, regional and national hospital and independent clinical laboratories across the United States. All of our members to some degree perform to the testing. As we have a keen interest in these issues addressed by the community. We certainly share the goal to bring the full promise of genetic and Medicare Madison to the health care system by corporate and the highest quality digest testing. We applaud the committee on such an ambitious and strategic approach to the multiple complex issues on yesterday's and today's agenda. We wish to focus on one particular item that was discussed yesterday, and that has to do with the regulatory oversight of genetic testing. We are preparing our formal response to the FDA on there recently released guidance document. Set these comments should be considered preliminary. There was a key question raised during yesterday's discussion that was at, is there a gap in the regulatory oversight of genetic testing? And the community reached the conclusion that support for political validity and utility may be an area that needs further study. Let me speak to that question from a clear perspective. The laboratory directive of a high complexity laboratory which is the only laboratories that can perform a genetic testing is responsible to ensure that the test systems provide quality laboratory services for all aspects of test performance. That this subsection 493. Further and more importantly in the same subsection CLIA express their requires the never tried director to insure that -- and I quote the test methodologies selected have the capability of providing the quality of results required for patient care. We believe that implicit in that statement is the requirement for the responsibility of the lab director to select test methodologies that have the capability of providing quality laboratory services for infected patient care. We believe this service is in keeping with the work and physician interest and pension management and is consistent with clinical levity. CLIA also it was the league requires in subsection 493-1417 that the laboratory must have a chemical consultant to provide consultation regarding the appropriateness of the testing order and interpretation of test results. This is also a CLIA requirement component in our mind used to ensure clerical publicity. Our intent is not to dismiss the issue, but to raise it as a point of discussion. We heard from the it sees that there are some very colorful players that are performing tricks to consumer tests that have a question of political validity as was described in the recent GAO report and the congressional hearings. All laboratories that do human clinical testing must be CLIA certified. They provide test that address special care and be held responsible for false marketing and advertising claims. All members RCAP accredited and most are lessons to be York and thus are subject to the highest level of regulation and inspection and test validation and accreditation. As was stated yesterday certify percent of all said the testing is performed and labs which are licensed by the state of York. That's not let the minority Drive regulations for the well meaning majority. Continuing that thing the second point I wish to make has to do with the new FDA guidances on ITT MIAs. Multi various asset in this novel. Essentially this guidance defines a new category of leverage for develop tests that will be subject to FDA approval and we will essentially make Laboratories manufacturers. Again, because our comments are under developed and without taking the stance of a need for such regulation that me touch upon the impact this guidance may have or we will have on the laboratory developed tests and innovation. Clip regulate labs as we heard yesterday. FDA regulates tests. There are fundamental differences of redundancies between these regulatory approaches which will make simultaneous compliance with both sets of regulations difficult and practical and burdensome. What are some of the differences? FT eight required quality system regulations to produce this is essentially identical products from the first get to the last. This is because it ensures that each approved product will perform in multiple settings as expected. CLIA on the other hand activates as the? A key you see package as to be described so that each individual laboratory on a daily basis can responsibly perform thousands of tests, individual -- I'm sorry thousands of different laboratory tests with an assurance of quality. The new FDA guidance will include a package insert requirements consistent with that the troupe performed the tests by multiple laboratories. On the other hand laboratory developed tests are developed and their standard operating procedures can be quickly modified and validated in a particular laboratory consistent with clear quality concerns. [ indiscernible ]. But most importantly CLIA allows for the timely ability to modify test report the latest medical knowledge and enhancements. FDA as consistently stressed the importance of smart regulations and following the least burdensome approach. The future of genetic testing will include numerous IDD am I a test applications. Our concern with the ability of FDA resources to keep pace without only the initial approvals but with the ongoing approval of valuable test modifications that contribute to medical innovation and improved patient care. I probably don't have to tell this community as an example of how this works, but I'll use one. HIP T not typing was used as a laboratory developed test. Laboratories have the ability to modify the test and include the latest innovations and latest thinking and latest information that was provided. It really revolutionized the care of patients with HIV and has done wonders for that dreaded disease. As time went on as the test matured manufacturers now have produced cassettes for HIV teenine typing and there be. It is the natural evolution, but the point is that laboratories early on can be innovative and moved nimbly and quick to make these tests available to patients. We appreciate this committees but will deliberations on this at all the issues associated with the need for increased had testing, but not at the expense of innovation and time a patient access. We thank you for the opportunity to, and look for to working with the community and regulatory agencies.
Terrific. That is great. Last paragraph, page one. It sounds like what you are saying here is there is a rule that says that any clear up must have a smart person and provides consultation on the appropriateness of an interpretation that the test. So do you really believe that that sort of must have is reasonable enough to say to the public that the political validity of a test being done by that laboratory is to cut the valuation of that critical Loti is sufficient because Doctor Jones with a license says I'm hired by the lab and I am here and CLIA says I am supposed to certify it, therefore I do certified that this is a clinically valid test and the interpretation of this test by a doctor that them lead to a therapeutic intervention on this kid is absolutely a okay. Go back, I don't worry. Is that what you are saying?
You heard yesterday a couple of things. One of the things was that the College of American pathologists has actually introduced additional checklist questions into their inspection process that get at these issues of test validation, particularly for genetic and molecular testing. Celebratory director, these tests are done in highly sophisticated laboratories, the attic and micro testing of the highest complexity. And yes, there are Laboratory directors that have the expertise and knowledge and ability to make sure that these tests that are ordered by physicians and are integrated into patient management have clinical relevance and are effective for patient care. So yes.
So the ability to oversight that process and how well it worked, how well it works -- somebody is going out there and saying, okay, Doctor consultant jobs. Let's review every decision you have made, I want to see the criteria used for the liberty and I'm going to make sure this is cleared away because you may be a well meaning talk, but how do we know. So somebody is actually on the case reviewing that?
We believe --
And by the way somebody in government and Cleo would know whether or not the appropriateness criteria used by Doctor Jones is the same as doctors met, Henry and Johnson and four different places. That would all be completely consistent advocate get that from CLIA?
I think you are talking about the expertise of the inspection.
And the criteria.
The other thing you heard yesterday, he heard from G.D. at CN asked that they are enhancing the individuals in this area of much the genetic testing. Because of pelletize has always moved to have individuals who are highly expertise in this area when there are genetic unlike the testing performed as part of the lever trace routine testing they present experts to do that kind of credible inspection.
The second question from me and I will see what others say. I guess I am a little confused. You represent folks who go through -- you must jump through the cap who and the New York state to? That is what your people to?
We have a number plates and in order to be a member you have to be Siepi certified. And he York state as we heard yesterday is --
So what if you are taking to cut the sound like you are a responsible position on behalf of responsible laboratories to our more than prepared and willing to be subjected to the tough regulations of New York, why would you say it is okay that the other 25 percent not have to go through that to give what is your remedy?
We are not saying it is okay. What we are saying is that not right for the dollar 25. They're need to be changes -- yesterday the recommendation came out of this group and said a multi agency approach. I think the main message we are sending is let's make this multi agency and let's do it in a way that does --
What do you want us to do about the 25? What should we do about that?
Ahead a minimal they all should be clear certified because we heard from the GAO report --
No, no, you are terrific. At the time to mature. Current you are willing to play by the Super CLIA? That is CLIA on steroids. That is probably illegal. If you are willing to play in New York level CLIA are you saying that everybody else should play New York level CLIA?
Our members abide by the cause of American pathology commission process and your state licensure. It is not for us to make decisions about this 25 percent. I really think that is a government responsibility. He suggests they should get together. What is the issue? What is the concern? If there need to be some enhancements the agency should look at it.
You are responsible organization representing mature organizations and members and others. And you have the opportunity to advise us as to what we should say. What do you want us to say about the 25% to give if we make the assumption you are asking us to make at the 75% that go through cap plus New York, that combination, you are saying it is pretty damn good and don't pile on any more than that because it is sufficient for the help of the public. You are prepared to say that for you. What do you want us to do about the 25%.
All become members of the ACL they.
Any other people please? Please help out.
I think the issue here is that there has been changes in the process of the Clea inspection to the College of American pathologists. Most laboratories perform a genetic testing today are CLIA certified to the College of American pathology. Have significantly big strength to specifically address questions of critical validity of this testing. And actually we took the template that the FDA uses for their review and kind of translated within our capabilities to a bank checklist. So there is a number of issues that are still very similar to what the FDA reviewed. The issue is the need to add more agencies to this regulatory oversight. There is currently over such for this testing through CLIA. The issue is that the FDA now is introducing that multi index analogy's a new category of testing that will have to go through FDA clearance. So in here we have the FDA saying we have the authority. And then.
Says we have the authority over the laboratories and testing. So I'm sure I'm finding that there is a need to increase oversight. The idea that I had is in the me to strengthen and little bit this specific area toward creation of a specialty for example to assure that there is proficiency testing to strengthen the quality of testing that is being done in these countries.
Anybody want to ask any other clarifying questions?
Eye to want to ask you about the last sentence in your fourth paragraph which says you are talking about the role of the critical consultant and you say that this was a component used to ensure political validity. Yes today GE and I think we have always understood that clear it does not speak to the address critical validity. She made that very clear. This sounds a little bit -- it is confusing. Can you clarify that?
I tried to build the case using the CLIA language. We believe that there is a very specific language in CLIA that addresses the need for effective patient care, tests have to be effective for patient care. Is that the word critical validity? We think that there is clearly comparable intent associated with infected patient care and clinical validity. And so our opinion is that language leaves one to perform in a way that has the test with the clerical validity.
I don't think -- I just wonder whether CMS would agree that their ranks in sheer political validity.
I think that is a question for CMS.
I want to thank you. I do hope as you heard yesterday that we are going to -- we try to read something and refer this to the Secretary to be thinking about. One of the things that -- and about trying to -- not just making an observation, but one of the things that private-sector people often do when there is confusion as they will often think that it is in their interest to step up to the plate and actually try to form public-private partnership that gets at the solution to these things. I sincerely hope that you guys will use the time available in the next week's to try to get with the people and government and try to see if you can't decide to get the right people together across government and the private-sector and try to work this thing out about somebody having to beat you in the had to do it. This is just a zero small advisory community working in the would try to do the best we can day-by-day. And all we can do is advise and so forth and so on. But I think a lot of people will wind up paying attention to the transcript of this kind of discussion we have been through and I have a feeling it will get some people's attention. If I have anything to do with it it will. So I tell that you guys will jump up to the plate and say, you know what, we will take care of this. Wherever this loophole have a problem as we look to solve it and that way everyone can go home. That is on you. Listen, you are terrific. Thank you. Do we have and the audience gets -- yes, you are. Absolutely. Don't feel any anxiety.
Thank you. I am not one to question the clinical -- from the George Washington your city. I am not questioning the validity of the test, but in the clinical setting usually there is a way to [ indiscernible ]. In this case their is test that is directly between the laboratory and the patient. It is 200 route that. We are telling him that in five or 10 years we can have a cancer. So how will we deal with this issue?
That sounds like a direct to a consumer issue and we actually use that in some ways as the example of what is now being considered this to about%. So we believe that those are the tests that certainly would require physician and the ball met. At a minimum they should be CLIA certified lab techs performing the test many there would be medical oversight and some acknowledgement that the test has to be effective for patient care and because of the position oversight we think there should be communication.
Usually this is done by mail. They send the results by about.
That was the whole issue of the GAO oversight hearing. Thank you for that. I think one of the things that our questionnaire reminds us again this that that is a big part of the complexity here and there is always a thing about what is so special about the genetics of. This is the predictive value, it's probably and production. That is what this is continuing to get at, this underbelly of concern around the clinical validity of these tests. It is not just your hemoglobin was up too low or high. So one of the things I want to make sure we think about going for it, is this sense of do we know? Do we know anything about the behavior of these certified consultant who are supposed to make sure in a CLIA lab at the clerical validity of these tests is actually intended to have addressed? Does anybody know anything about entered Richard reliability? Is there any set of standards in that regard?
CLIA has specific standards.
But the standards as far as who is a consultant. On questioning does anybody go back and look at the behavior of a consultant? Does anyone know what the consultants use as a yardstick to determine critical validity? Is there a standard format? In other words, could you go back and look at performance assessment criteria for a clinical laboratory consultant to make a decision on chemical validity? How do you know if they are any good?
In the process of inspections if you are using the CAP with a specific checklist your inspector will come and look at your clinical validity not only of what you have introduced in the last two years, but they go back to anything he had done the past.
Of the answer just to make sure we heard that -- and this is a very helpful comment. What we are hearing is that the cause of American pathologists guidance may be good enough and specific enough that you could use that as a performance assessment tool for the quality of the consultation from this particular person.
Just a question of some fact if you have that, at the end you mentioned or this first page you mentioned that in the GAO report certain maps were called very colorful players and some of those clubs are during direct to customer test as we have heard. How many of those labs -- I don't need a specific number or a thing. Are some of those labs in a CLA? Are any of those labs CLIA certified? Do we know? Okay. Thank you.
All right. Here is the deal. We have people that have to leave at 3:00 p.m. We will take our lunch break now and the actual what is available early. We will be back in this room ready to rock and roll at 1:10 p.m. Our guests that are coming at three were coming at 115. So we don't want so be it to miss anything. So you are going to come back at 1:10 p.m. and people -- minutes of business. One to 10:00 p.m. The presentation stars and we are out of here early. Thank you all. See you at 1:10 p.m.
Steve, are you here? We are very pleased to be able to welcome Steve croft, director of the MI8 of the sub rare diseases to provide us an update on the collaboration of a test translation of the CE T P program which promotes the [ indiscernible ] and also works actively to encourage clinical labs had research collaborations. Steve protest about CE T T in early 2005, and we are eager to hear how the program is progressing. See have the scene minutes of presentation and buy or so minutes of questions. You do your thing.
I will try to keep this moving. We will try to keep things moving. Which one? Sorry. Once we get through the adjusted to appear people get this moving. This has been a real unusual program in which we have had the opportunity to start something art from the beginning and fun as we go. And I have to say that we have met with a lot of very good comments from many people and the cooperation, this is program that was an idea that we really needed to do something to facilitate the transition of genetic testing from the research workers [ indiscernible ]. O I did hand out copies of the slide. I won't use all of them, but I try to reposition 10 or 11 of these that I will actually use. It was just a lot of background information be used to explain the program to others and I wanted to limit it to the ones I would talk about here. I will try to go forward. You see here the partners we have been involved with and I have made several presentations to the advisory committee in the past and we haven't changed partners. We solidified partnerships particularly with the CDC folks and the CMS people talking about genetic testing. And then in have come in very very much support of how we wanted to port in this program of transiting Research genetic testing into the clinic. And these are some of the program objectives, what we are really talking about, new genetic test that development and the transition of that from Research to practice. And we would like to increase and improve the education about the rare genetic disorders, and we also are thinking also about trying to find ways of collecting and storing the clinical and genetic information so that there can be summed Jeanette had phenotype correlation. Of course there are other programs going on in research and through the end at eight that people have been discussing at length. So we think we have a nice job on this aspect. So we have had several meetings focusing on genetic testing, and the first one really was to identify the issues and the meat, and that was focusing primarily on like the genetic testing. After we started the set program and working on that the biochemical to the testing is an area that we needed to have some emphasis I'm. So we were able to pull together a conference about six weeks ago on biochemical genetic testing. And the other two are for the reports from those meetings, and we are circulating the current report from this meeting. I would say within a couple weeks there should be a website and we will pass it on to Sarah for them to distribute on to you. So it is coming. We have a draft coming out and we want to pass it to all the participants to give them an opportunity to comment before we move forward. I just want to go over briefly some of the recommendations that came out of the meeting and then some of the programs that have been implemented as a result. The first one was that the program should be expanded and should include biochemical to the testing. And the other emphasis we found was that we really need to start looking at those tests that are only available in non U.S. a laboratories. We need to get a feel for what is going on and why tests aren't available here in the United States. We are working on an international collaboration and how to facilitate transfer of samples and quality assurance of the labs outside of the United States. So we will be looking this as well as we move forward. As we did with the molecular testing we had a laboratory volunteer to help get things started. And it has been very successful. We really began to initiate these activities of developing these genetic tests. Who would like to see a similar consortium the developed and biochemical genetics testing and we seem to have a group of individuals who are willing to bring themselves together and formed this consortium. And where we go in the future, we are really not sure. Of course so many things depend on the availability of bonds, but certainly this as a program has gained a great deal of the acceptance on the outside world. The laboratories and patient advocacy groups to have a need for having the genetic test developed and made available. But we are also getting a substance within the NIH structure. So we will gather resources to facilitate the transition of the test and development of tests. In fact we just had a coat on the project with the National Institute of Diabetes and kidney diseases to help fund the development of some genetic tests. I would just mention here in a few maps. So things have been drawing and moving very nicely. Again, as I mentioned to Linda Bradley before the presentation, I just can't believe the amount of support and cooperation that has come about in this area. So it has been a very rewarding to start a program that helps support and have it grow. Now of course our big problem is having enough money to sustain the growth and have it grow even further. They're is a great deal of concern about the training of laboratory and clinical personnel and biochemical genetics testing. I think that many of us -- not too many people here are as great as I am or happening here or of losing her. In biochemical genetic testing particularly the issue has been raised that really do need to find a way to increase the number of individuals who are willing to participate in this activity and, a practitioner and lab director in the future. Again, there was a feeling there would be some consolidation of some of the laboratory activities with the refinements in genetic testing and other things in the future. But at the present time their is need that we have to start to look at for increased training and sustaining the training sites. And I no there are people who have this concern as well that we really to me to look at. There was a mention that we need guidelines and they should be developed to insure the quality of testing results and to petition of diagnosis for inherited metabolic disorders and disease. This is something we are looking to the American College of Medical Genetics and Society of metabolic disorders and others to help develop some of the guidelines that will be useful to the commission's and the laboratory people as well to help them really get a better understanding and a appreciation of the test and what is needed. With Quality assurance the measures need to be enhanced for the various laboratory tests. We spent some time talking about that and these are several programs that the other individuals who worked on outside of government people rarely felt that society had a responsibility with the professionals to bring these ideas together. And we are noticing more and more in a national cooperation and a research effort. And this is going to just move right into this whole idea of quality assurance and transfer of samples across borders so that this cooperation of the collaboration will become even more important as they move into the future and particularly for the rare diseases we are finding more and more than the collaborative research efforts are extending beyond the borders and truly becoming international. We are finding more and more collaborations' being formed and they are working on all aspects of research. So this is another area that needs to be worked on. Again, as always use information resources and have a need to be enhanced to provide easy access to that user-friendly information on biochemical genetic testing. The availability of testing services and testing strategies is to be expanded and exposed to the public and other practitioners more extensively than what we have done in the past. And so the outcomes of the meeting is something that everyone has agreed to do. Our office, we are taking steps now to expand the set program to include by Chemical to lead testing by adding several advisers and the groups on the review team's to help review the biochemicals genetic tests when they come in for consideration for support for development. Gene tests that Bonnie pagan has primer's possibility for, we will be providing specific information and specific genetic testing either by expanding the current capacity or by setting up a companion side to subcontracting. And you see there the you see and is committed to developing testing guidelines for users and providers and cooperation with other professional organizations. Again, this is something -- this is she just needs the cooperation of everyone in order to make it work. And we want to get the best information out to the public and practitioners and researchers. Laboratory directors and staff, so many many things are starting to develop. CDC, they will prepare a report of the meeting and we will soon be posting that report on the Web site and will be making that available. And the steering committee will review the recommendations to refine the roles and responsibilities, and then to begin efforts to see what else is needed in the near future and we usually give ourselves about two or three months after the meeting and then start to think about where we have to go after this meeting and what needs to be done. And as you see we have been running about every year. So we are getting to follow up and review what has happened during the past year. Again, it is a good way to look at responsibility and see who is taking up the initiative and moving things forward. So we will continue to do so. Here are some of the tests that have been developed to the network. It is quite a few different ones, and you see there that the spread to various laboratories there are developing the test with a couple of commercial organizations that are helping out and a couple of different methodologies that are being used to develop the test. I would like to add one other thing, we have done also since we are involved and the patient advocacy groups extensively we have gotten a group of about six or eight individuals, leaders of patient advocacy groups that have come together and gone through a little bit of a training program , and they are now serving as a resource to other patient advocacy groups to explain the program and what all of this means and what the set program is and what the values of having this in the genetic test developed and made available. So they have come in with a great deal of enthusiasm and we have them breaking out into various groups. Some of the experiences we have at up to this point, again the need for templates of educational material so that people can understand what genetic tests really mean. What can they expect but before, after, before the test it administered and then looking at the results, what should they be aware of? So people will be working on these templates. And I guess we have to figure out better ways for the test results to be understandable by everyone. That is a major major issue. I think it is heartbreaking down there for information and sometimes all the scientific and medical language we are so used to using to make it barely understandable and useful. And I think I would just end it there. I have several slots on procedures and activities, but those who can look at and they are highlighted within the web site for you to look at at your leisure. I will try to answer questions.
First of all, banks allowed Steve.
Yes.
I was wondering if your group had thought about the issue of patents and how they affect what you're trying to do? Has that been an issue?
That this in this trial. We do more than [ indiscernible ]
My goodness. Yes, we have stayed away from the patent issue a little bit by try to pick up some of the tests that have no patent life on them. Just for now I think we want to gain some experience her first. We will see how this can all be done and then start to address the issue of parts and test with patents and rights.
So is it fair to say that your decision about what tests to develop an all has been want to sow dissent by weather patterns exist?
I would say yes. It is an area we are not really prepared to deal with yet. It is something we will get into as the gang war experience. And we didn't want to run into a lot of what chance here when it comes to developing the little circle as far as developing the test. We thought was just go ahead and get started and then some experience and use the Internet Express and keep growing and changing as we go on and we will begin to address the problem. It is a big issue.
And that has been with us for about the two and half past years.
If you can give us any help letter on we will be happy to have a form of this if you like. We would be happy to sponsor a workshop the part of a conference on this issue. Always open.
By the way Jim is all over this pattern thing.
Okay.
I really want to commend you and your attention to the biochemical testing. It is an area above static testing that is not receiving enough attention and we started to see that it is now being offered widely. So I commend you for taking these issues. The too, wish to make is one of the issues we have regularly in said testing is the ability of control. What are you working with the CTC and with the genetic testing quality-control materials program or do you have any interest but the NIH to deal with this issue?
I guess that is one of the nice thing. With the partners that we have everyone brings something different expertise and certainly people from CDC in the Quality Control area we are in close contact. We have the partners list that the people are working and really didn't reflect the attendance of those in different groups. We are keeping up to speed on quality control and recognize this as a problem.
They're is a continuous lack of organization and the support of genetic testing, not just rare disease and it seems like you are quite to the process, but I would strongly encourage you to work with the professional organizations in addition, to the ones you have, other ones that are going through some positive things and try to really understand how we interpret these results so patients can fully understand.
You are right. I think that is all that partnerships have to come in and have them put into what is going on because we need the professional societies and organizations and patient groups to really help us get the message correct when we are putting it out to the public. And then the health professionals that have to deal with working with the patients and families, that is why I think this coordinated and collaborative effort is really so important and it is a nice model to try and develop the information that is so badly need by so many people.
Me to my from what we have already gone through. The idea is not to reinvent the wheel. We have gone through this process already and we need to gain information.
It is quite a process. It sure you get the right message and the right timing of information.
I just was wondering if you could comment a little bit more about how the educational materials you are developing would get out to the people that need them when they need them?
Again, our plan is to put it up on the Web, but the is case of affirmation of the Web and interact with the professional societies that most likely would see the patients and the genetic counselors to would be counseling patience. It is a multi System multi it and approached to try to get that information out to people. So we are going to be using different resources to contact the professional societies, the to the counselors and the patient advocacy groups and then whenever physician groups -- core is most likely to see the patients, that is who we are looking for. We have one example which is the first one that to really get the market with educational materials. Again, it will be the first model we have of houses working and we have to go back and assess are we really reaching the audience is that should be reached with this message about the genetic tests and all the information.
Have you thought about linking teethirteen test?
There will be a change in view for each of these, and as we go round working on these as we go for and develop the genetic tests, I think 18 review will be made available. That is the one good thing about having them working with us. We can really make sure we are turned into everything going on there.
Give me one more.
You were right there.
Would you give us a sense of prioritizing the test?
It is really -- I'll go through a review and we have a review board with a team of reviewers who participate and looking at the information that is provided. Is the test ready for translation into? What is the current status? We look a little bit at the cost and can be afford that right now and where we are. So that is why we haven't had to turn anyone down because of the cost of developing the test, but we to look into a lot of this background and is a laboratory that is involved, have they completed the test in a research laboratory? Has it been useful? We are looking at the utility and a lot of other factors that come into play before the decision is made. And what I would suggest is if anyone has a test they are really thinking about to get in touch with and the faucet who is really the distributor of information and have him the view through or the people through what is needed and how we will move forward. So we have been very open and accessible about how to get a test translated. It is a decision process that the review team goes through and then they make recommendations to the steering committee and we try to find funds if we don't have them. This is where we have been turning to some of the Institute at NIH especially if they are in a research per call at the time to try to get funds to develop a test.
Great.
Banks rollout for the update. Just a quick question, is there a procedure that you are emplane or collaborating with somebody on how you are setting up to collect and store critical of genetic information?
I can't say that. I know they are looking at collecting that information on a database and installing -- trying to maintain the energy that is required, but I could not say for sure I don't know. I certainly can get the answer and get back to you people certainly are more knowledgeable about this than what is going on. Unfortunately I have been able to spend the time I would like to on this issue, but I'll get back to you.
All right. Scott?
I'd just want to mention that the biochemical aspect of teen testing has been needed for a long time, but do you think that availability of affirmation by increased the demand for biochemical genetics services to the extent that will become problematic? More so than it is already?
We have been confronted with a few of the flaps setting down and some other issues because of legal problems are rising. It is certainly something we don't want to look at, but the reality is that we need to have an emphasis on this to insure that the biochemical genetics test remain available at the want to say until such time as block the testing becomes available, but there are certain issues with biochemical and Senate testing that we have to address there are weaknesses that people have spread that we need to look at and make sure that it sure up enough that people have confidence and the results that are coming out. We are looking at a decreasing population of practitioners and the laboratory directors in the area , and these are all issues. And biochemical genetic testing is not going away because of molecular testing. So we must ensure that the services are still available the best we can. So we are looking for ways to increase the training aspect of this and that is hopefully what will take care of part of the situation. I hope I answered your question instead of dancing a little bit. It is the but problems we are trying to resolve and of course if we had unlimited funds we could do these things and have lots of training programs because the parties are interested. It is just a matter of putting things down on paper and getting them out and starting to work on them.
Thank you. In the last ones? Terrific.
Thank you so much.
At it back with you and we will now that down.
Since we will get together.
Thank you so much.
We are now very pleased to move to our update from and IH, the proposed policy on genome wide Association studies, G. W. A. yes. Susan Sherman this is the deputy director of the National Heart Institute is now with us and we appreciate it. That me just remind you that this is an important policy proposal from the NIH on whole genome Association research. And IH want everyone to be aware of the proposal which is generally referred to as the [ indiscernible ]. And we wanted to hear more about it because it raises some of the same policy issues as the topic we have spent most of today discussing. In IEH has a high priority because such research will be to a greater understanding of the common genetic factors that influence health and disease and possibly the better ways of predicting and preventing disease. This type of research is also important for the development of personalized Madison. God, am I good at filling time. The G to BAS proposal has an important component and at facilitating the Schering AG of clinical information that will be generated by the research including the creation of a central database. NIH will house the data. We cannot but away from data and databases and all kinds of stuff here. Such a proposal clearly raises important policy questions including some that we have identified in our large population studies report. They are currently seeking public comments on the proposal and the agency is working hard to broaden public awareness of it. Susan is a prime mover in the development of the proposal and so she is going to sort of chap with us about it. And once they get that computer deals were aware we will be able to --
You may just have to listen to me.
Well, that is fine too.
For some reason it is not protecting well.
The one thing I know is this because whenever I'm presenting and I have these troubles my anxiety level is very high and I get freaked out and tents and then everything goes straight to hack. So the main thing is just relax.
So now you're fine and don't have to worry because it is already up there. And would you also as you get into the presentation, which you sort of again help us to understand from early on sort of how UC -- are you doing this for information for us or is this something you want us to listen in to the four?
Well, okay. I'm going to start out with that. First of all, it is information, but the other issue is we are in the middle of a public commentary. Right now and we are. Eager to hear people's input and advice and I want to give you an overview of what we are doing and why we are doing it and how we see these extremely complex issues. As we are trying to balance a number of different issues in terms of potential benefits and risks to the numerous groups. And they are not easy solutions. And so it is going to be a matter of figuring out how to make things really work. My name is Susan Sharon and I am the deputy director of the National Heart lung and blood institute. I'd spent 30 years as faculty at case Western Reserve. I ran a laboratory and have been heavily involved in clinical research of multiple types. And so my background actually is not from the standpoint of NIH administration, but from having been out in the trenches during these kind of work and scanning -- spanning a period of time of tremendous advances in pediatric hematology and oncology. Website is rather different than what it was some years ago when I entered the fields. I can't promise you the slides will be credible, but I can probably interpret them for you. I don't want to spend a lot of time about this. We haven't come up with a better name for it. I think maybe when we are done with the public commentary. We will have a contest to name these things, but what we are talking about this -- this is really great. But we are talking about is a group of studies in which we are looking at scan's across the entire genome. We are getting 375 -- hundred thousand symbol nucleotide polymorphisms which are then month to the phenotype which this [ indiscernible ]. And so we have bought control groups and patient groups. And the idea is to help us better understand the geology and background of diseases which often have a genetic component, but may also have environmental components and behavioral components and may have lots of different components and to try to sort some of these things out. And to be able to come up with better ways of predicting risk of implementing preventive therapies and preventing the development of progression of disease and developing new diagnostic and their peaks. One of the big issues that we look at from the standpoint of NIH is that and I it really represents the public -- our job is the stewardship of the public investment in the biomedical research arena. We are really trying ultimately to improve the public health. And we really have to be able to try to the -- if we are going to stored these resources will we want to get the maximum benefit as we make progress. We have for a very long time encouraged the wide sharing of data. We have encouraged people to put papers on the Web and forms which are widely accessible to not only investigators, but to the public. The work that we share, we are eager to have widely available to people. And one of the things that we are encountering right now -- and as was venture their is bit of that information glut. It is now a different order of magnitude, but it has ever been before. Basically we are doing studies now and I'm sure many of you have seen these with the steps and you have thousands of hundreds of thousands of pieces of the formation. We are now generating far more data than any investigator or any single group of investigators who will ever be able to analyze. And many of the studies that we are doing and we are supporting our very resource intensive. First of all, they cost a lot of money, but it really is more than that they cost money. Many of these studies are unique studies done on very limited groups of patients. The ability to get ready well defined phenotype data and to link it to be keen to pick information to compare it with people who are not affected with similar sort of diseases is going to be very -- is very limited and you don't want to be particularly during this multiple times. If we are really going to benefit the subject to are participating in our research we want to make sure that that investment is maximized. So rather than having the same study done over and over again we would rather have the data were people could use it and analyze it in a number of different ways to be able to come up with new beneficial interventions, both diagnostic and therapeutic. It is very important that the participants in our trials have their privacy protected. So that is a huge issue. What we are talking about largely is balancing the me -- maximizing the benefits to the public health with the investment we are making and the support of research and trying to ensure that the privacy and safety of the participants in these studies are protected. They're is a huge intellectual property issue and they heard a little bit of this discussion before because one of the things that has happened is that as we are coming up if we come up with new therapeutics if they will be developed people have to be able to to protect their intellectual property or they won't actually developed things. On the other hand it to -- the things are planted to early they make type of data which then won't actually be available for publication. So what happens to this -- really is about the beginning of 2006. As we are looking at our room grant portfolio, but we are finding is that we are receiving exponentially increasing number and double exponentially increasing cost of applications to do genome what Association studies. This is on persons and our assistance with heart long and blood disorders. And [ indiscernible ] is the director and Doctor Collins is the genome where we are discussing a number of these things. And we felt that it was going to be important that we develop some policies that would enable us to ensure that investigators share their data vary widely as long as that is consistent with the consensus provided by the subject. And so we started in the discussion between our two institutes and put out a request for information from our investigative community and give us some idea of what they thought and using that information we started belting a policy. And had a discussion with the other institutes and center directors and said we would be doing this, would you like to get them. And it rapidly progressed to the point where everyone said it is not a good idea for us to have different policies across the NIH. It is confusing to the investigative community and confusing to the participants and studies. We really need to develop some kind of coherent policy. Now you understand this represents millions and millions and millions of dollars in research applications. We are bad in a chubby guy doing genome what a suspicion studies on a number of the coverts of patients that we studied some for many decades. We are doing genome wide associations and the studies started in 1948 and now include three generations of subjects. One of the things I want to be sure you understand is that wide sharing of this data is already taking place and has been taking place for a very substantial period of time. What we are looking at doing is to try Todt develop a coherent approach to those to try to change the culture and investigative communities so that instead of having a total proprietary sense of their days that they are able and willing to put it out there and let other people look at it. This is in order to maximize the benefit. And it also becomes clear that if we are really going to be able to provide optimal protection for privacy and intellectual property issues to standardize the phenotype and information we are getting and to standardize the oversight and really protect folks, it is very helpful to have a single portal of entry. Now we may have different ways in which you get in there. There may be different standards that apply to how you access did that depending upon what is in the data. But we would like to develop something that is reasonably coherent. So that is actually what we have been working on. It is very easy for you to find a lot of the genome why this decision Data available right now. Project at the NCI looks out across state breast cancer. We just posted a vast amount of data that Tino Motta association. Among other things you can go in and try to manipulate and see that you actually do need to know what you are doing if you make any sense out of it. It is not like it just sits there and says, this is me. It really doesn't. On the other hand we are talking about genetic data. So it is intrinsically potentially identify will. So our guiding principle is of the greatest public benefit being realized if the data is available under policies and procedures that are consistent with the informed consent provided by the participant in a timely manner to the largest number of investigators. This is what we are trying to accomplish. They're is a wonderful cartoon in The New Yorker a couple of months ago which had a couple of cavemen sitting in their cave and they were sitting over there fire sang, I don't get it. Here we are with lots of exercise. Fresh air and eat this high roughage healthy diet. How come we are all tying in our mid 30's. So this is the issue. If we are going to make advances we better learn to do something with them. So we broke it down to a number of elements. The first is did the management, how did the did to get into something that we are going to be sharing. How did it get out? Publication issues and the intellectual property issues. One of the things that happened is we were having this conversation and it became increasingly clear that it would be difficult to have either the kind of coherence that we felt we needed, particularly for such banks as the extent of which the to know it does that are traded and the extent to which the Finance to the data is defined unless we had a common repository for all of it. If we add a common repository for all we need to have it done in such a way that we can ensure that there is a long term long standing commitment to lead. And so we ended up with our proposal being for the depository be at the National Laboratory of Madison at the National Center for by the collapse of the in CBI. So the idea then -- and release are about this. The idea is that it is going to improve the public health and actually maximize the investment and return on investment. So what is this about to give what we are looking at if I can actually make this work so the genome wide association data, but phenotype and teenine type would come in under peer review process at the NIH, and what we are proposing is that people who do this research with an IS support basically must fear the data. Again consistent with the consent to having it be shared. We will however as we are creating the repository be happy to receive data from non and I it supported investigators to meet the standards and are interested in sharing. I am going to come back to this in a minute because it is actually something that has quite a lot of interest among other things from industry who are remarkably interested in sharing.
And the submitting investigators and the institutions at which they work are responsible for submitting the data using a random code with no identifiers and note any limitations of the use. The contract with the participants happens here. The quota is maintained in the institution and the CPR and and I hate government have no way of knowing do anybody else. So then discarded like the genotype and phenotype data is put into this repository and there will be -- it will be possible to get access to data which our aggregate which one could you, obviously, access to any kind of information about any kind of individual. You won't see any of these single the Amittai polymorphism. If you want to gain access to any thing beyond that, particularly in a gang which might give you access to the blood patterns, you go through a controlled access process. And there will be pre computed data posted on the Web. This is designed among other things to make it so that the of this association is the meat available. This becomes obvious and palpable. And the things that would be patented would be things that were downstream from those because they would have to involve manipulations to the data that are done by the secondary investigators. As you can imagine we are putting a tremendous amount of time and energy into discussing the overset for each one of these. So the oversight is that a repository itself. The oversight of access. Much of the oversight of the excess is likely to happen at the level of The Institute and senders that support the regional studies. Does there will be in a better position to be more accountable and to be able to look at what is proposed. Anybody who wants to actually use this data then has to submit a request. It does have to be in I it on it. But it does have to be at an institution because we are going to let the institutions take responsibility for some oversight of to is actually getting access and what people do with it. So they don't have to tell us what they are planning to do. They have to agree not to identify any individuals. That will be easy, but if it is absolutely true that even now some of the potentially identify will have some of these technologies get the best and a lot of this is anticipated to change. This bank goes to the did excess community and they will have data set specific access rights to these data. Obviously there are really infant numbers of applications here. There are promising implications and patent applications and intellectual property implications and implications of what is actually done with this. This does create some burden for the institutions which first of all had to tell us that the debt that is coming in is compatible with the informed consent to stock of the by the participants Tarija and also for the institutions where the First and Second and is our they will be asked to help participants to have access. There are a number of -- a number of industry increase sub-par of people wanting to participate. What we have learned already is that most of the industry that is very actively involved as uses to limit data is interested not only confusing [ indiscernible ]. There is a this group of this study is called gain of the genetic [ indiscernible ].
This is the foundation and then money comes. It is a public-private partnership with NIH money. And in the game settees the investigators tell us what phenotype they did they have and if they are approved investigators send their samples and Pfizer actually does the teenine typing. The condition for the free to attack that that is that they have to be bowing to share with everybody else. So that is actually recently funded. We are just getting going on that and it does require a wider sharing. Said the investigators will permit this data and we will have to provide information about what they're doing [ indiscernible ]. And the investigators to request the data we will have to present a whole bunch of stuff as well including telling us the only what they planted to but also to tell us what they have done among other things to try to enhance the extent to which we can share the results of these studies with the participants. Now we will know and Italy who they are, but we can put it out so that people actually have access to it. So we met with 08RP to discuss what it is we are planning to do. We met with them to talk about secondary use of the debt which constitutes human subject research. It is removed from the original participants and secondary users have no contact or ability to have contact with the participants. It is stripped of identifiers. And under the discussion that we had with 0HRP they feel that this does not constitute human subject research. It is important and there may be pieces for which it does constitute human subject research. There are some studies such as the team environment interaction studies which are currently under way in which we may actually need to have some of the data which constitute a identifiers under have the or it want people. You are allowed to have anything that tells you anything smaller than the state that Simpson. Well, you may actually need to know what these zip code is in order to be able to make anything out of it. So their suggestion was that we customize the oversight whether it is an institutional review board or some other form of oversight to the situation. So what we are trying to do now is developing. We are not expecting this to be one-size-fits-all. We are expecting to have to do a certain amount of customization. Said the issues for participants I already mentioned. There are, of course a couple of things that are of very significant concern. One is the issue of genetic discrimination. We still don't have was that private genetic discrimination. [ indiscernible ]. We are embarking on to the typing many of the courtroom the studies and then we will be involving participants and the studies. We are involved in extensive conversations about all of the issues up protection of data and how we will to access and again this is not -- I can't give you a simple answer because it is a complex question. So we put out at the end of August an announcement in the NIH guide and in the Federal register with our draft policy. We worked very hard to keep it short because it is short and really focusing on policy other than on the implementation. Of course in many instances the devil is in the details and so the implementation makes a lot of difference. We were trying to do it so that people don't get lost. It is hard enough as it is a difficult to understand all of these implementations. You can see what happens is we have the each branch one usually has which has the to this effect of going along with a low rate of responses and as the come here you get a little plastic and responses. So we actually extended the deadline and I at the end of this month will be closing out the public commentary program. On the Web. And then that will be followed by a town hall which will be on December 14th which you are invited to. That will be web cast and you are invited to participate on line as well. We are asking really these questions, risk and benefits and additional protection of the proposals we have for putting this together. And then any specific resources investigators and the institutions might need to meet the goals of the proposed policy, we are eager not to have totally unfounded mandate on our already overwhelmed institutions. We have the public consultation. If you go to the main and I it would set go down to the Web site to research. The first one under that is a genetic [ indiscernible ]. Or if you go into global you will come up with our policy. And that will take you to it as well. Being so that is what we are doing. We are eager to have commentary. We expect there will not be unanimity. I see people come at things from different -- people will weigh the relative benefits and risks in different ways. And so we are putting a process in which we will be able to take these things into account and try to put in as many controls as we can. We cannot make any of this totally risk free. On the other hand the downside of not sharing the data is we don't get the benefits of the incredibly valuable sources at a point which we think would benefit us. I will be happy to take questions and comments.
Thanks a lot, Sharon. And I think that just over all you are able to be with us yesterday or the day earlier, but we put a lot of energy into this idea of the databases and how those things connect. And so one of the things that we hope, I would share from my office, from my seat at the chairmanship is that you would, just to make sure that the American Health and Russian efforts of which you are boss, the secretary is so involved is that you are connected to that activity. Can I just ask you, is there an explicit conversation going on between this kind of data collection and what is going on? Is that familiar to you?
I am aware of what is going on. We are looking at it purely from a research standpoint. We are looking at a slightly different aspect of the same picture, but I think we have a sense of the overall thing.
Bid. Emily to give.
Do you anticipate, was to create a database of a certain size that you will also entertain what I would call sort of purely bio and dramatic proposals from investigators?
Well, actually that is a huge piece of this because one of the things that is a limiting factor in our ability to use this data is we are not yet skilled enough in analyzing. So one of the major things we would like to do as a part of this -- and this comes into the overset piece that is over the repository is asking the secondary users to share their methods.
Okay. So there will be secondary users to can, and and never did a thing in the lab and never touched a patient but you can't just go in and analyze the data with new questions?
I think many of the folks who will be using this data are primarily statistical folks and buyer at a dramatic focus and you know not necessarily they are very likely not to be people have never actually seen this precooked and you will have a gatekeeper mechanism where you entertain specific proposals?
That's what it is all about.
The part of it is just anyone who is getting funding to to the but part of genome wide will have to deposit their debt?
Right. Correct.
[OVERLAPPING SPEAKERS]
Because the point at which people are getting the data that can be positive, they are in contact with participants. That is clearly a human subject Richard. The secondary users will not have such contact. It will be really totally separate oversight, yes.
Now I get the toilet of flipping the order. So Kevin gets to go.
Thank you very much for the presentation. I am fascinated of one hand because I think he did an excellent example of some of the attention if we are going to be getting. Because the very power of this database and $0.1 for the research and all also raises the issues on the other hand side, ethical and policy requirements. And I understand your current to try and anonymous everything, but I'm thinking about considering what is going to be in that database both genetic and in typical information. If something goes to a researcher who is involved with a particular the small patient pool, the possibilities of the identification just increase exponentially because there may be certain characteristics that allow for relatively easy edification in a burden identification.
That was exactly my point.
Right.
That was exactly my point, not only about cramming, but also the case for our other things.
You mentioned there are participants of Balkan the oversight and that brings me to the focus of my question. When you get to your informed consent procedure and as you mentioned this is not a totally risk free endeavor, how is this risk captured in your informed consent to give who decides what the rest is and how it is brand and how it is explained. How do you look ahead [ indiscernible ].
It is a very touchy question. That is one of the big issues that we have right now. We have a lot of data and specimen after which you have to look at, does that original consent that was obtained a patina or 20 years ago, is that compatible with data sharing. Regardless of what it says on paper did the folks who signed it have a clue that this was going to happen? Obviously not. So one of the big issues we're dealing with his we think we are going to have to be dealing with retrospective if she's had studies somewhat differently from prospective studies, and we will do the best the can in terms of assessing potential risk. We are not arrogant and not to think that we will be able to predict all of those risks. We think this is rapidly changing.
When you say you will do the best you can, do you have a sense of what that procedure will be?
A huge amount of it is going to be the issue of how the repository is handled whether or not folks can download the data and where it goes and a lot of that kind of thing. The other piece of course is what it takes to be able to identify somebody, which right now really requires a comparison specimen for first-degree relatives to be able to do that. But increasingly as we are able to analyze this data we will be able to sort of make predictor's about phenotype from the date itself and I think we are anticipating that is likely to happen. And I think we are going to have to sort of say we all make these kinds of risks -- risk assessments every time we crossed the street and use an ATM and buy from Amazon the outcome. So basically what happens is people who really aren't willing to assume any of that risk probably will not permit the digit to be shared. And again there will be a trade-off. We will try to be very honest with folks. We need them to trust that people to the best we can, but we also recognize that we are not all powerful and less. This data, whether we hold it at the in CBI or whether we contract with somebody else will be subject to flip because even if it is held by a contractor it is on our behalf. One of the things -- we are in a situation where we are in territory in which the science is way ahead of the lot. So we think a river piece to come out with that. And we think there are purchased to a number of these things. Certainly there are laws against gender discrimination and things. Because we are saying it is okay. We are completed identified and therefore we have this set of privacy issues and then you turn and say this is the ultimate identified. And the answer of course is it is both.
You keep saying we, we, we. Altman the I guess my question is, who will decide if what you have done is adequate? Is this an in house decision?
Well, we feel that we need to take responsibility because one of the biggest waste the get into trouble is if we don't have accountability. At a final level we will have to. This will be a process in which we not only take the current level of public commentary, but we also take on going public commentary as this goes for it. So we are listening hard. I really mean it when I say inviting me to comment. And we are indeed listening hard. That I think the big issue is if we get to a point where the responsibility is to defused then it becomes too easy to sort of say it wasn't my fault but there is a problem. And we do want accountability.
Hi I am wrong and from the Office for Civil rights. As always we offer our technical assistance but the privacy issues, but on another point you have mentioned ongoing public input and, at. And I know that when the press release came out at the end of August you talked about a public forum in early December.
That is correct. I just said that.
And where is that?
It is out in Bethesda.
We were hoping to gather the commentary that has come into us to sort of ran a big piece of that discussion.
That was payback for early.
I have two questions. One is the data that I understand would be identified, will it be at the five as individual level data or aggregate of all did the?
And so that's good to the second question about into the data. How often at that defined his really challenging and how one defines diabetes or hypertension or illustrative breast cancer. We will there be some sort of guidance or glossary from N.H. as to what would be the definition?
One of the things we are involved in now is establishing what the standards will be for the finish to the information. We actually will be accepted at that are in accord with the content of the information that get to the standards. And we anticipate that will take a significant amount of time. And the gang initiative for instance a huge piece of whether or not investigators -- whether a given project was funded had to do with the to the quality of the fat out of the dancer. It is actually much more difficult. The Fiat said piece of it is much more challenging than the tentative piece.
I strongly agree with you that the phenotype is a lot more difficult than the content. I am strongly to encourage to develop a clear stand it. My question actually is about intellectual property. These are deposited into a database and we already analyze data. One could start identifying patterns but different phenotypes. How is the policy going to deal with developing intellectual property.
We like people to develop patterns. We would like people to protect intellectual property as they move along and start to find targets but may be useful for diagnostic and therapeutic. Because they want it developed the most people do that. So I think it is important to understand we are not discouraging pounds over all. We are trying to ensure that what is patented at such an early stage is sort of like not putting 18 are not putting -- as banks get patent at a point at which you actually can't do anything with it and then it locks up a whole lot of other banks and doesn't achieve the goal.
How would you do that?
Party?
How would you achieve that people don't paten things. Early?
When we post the date we will post the first line through on the biostatistics our linkage this equilibrium. And a number of the simple associations we have identified, but those will be out there. And because they both be out there --
That data will be publicly available already?
Desperate that is what makes it obvious. Because we will put it out there. It then becomes and the public domain and is obvious and therefore not patentable we go.
I'm not following this, but the data or association -- the association says publicly available data.
Yes.
But that will be posted with the first pass through. That will be posted with the debt. And then the pieces that are subsequently -- the secondary users as they come up with big brains, and presumably we will be developing targets for diagnostics and therapeutics and we would like them to pound that because that will encourage them to develop the product. But that would be what would be called non obvious.
Is there anything talking about Richard Japan's?
You can do that.
Thank you. One last quick one. The, you might want to start making sure to what do you have fled to give we will give you a chance to fill.
They are already on their. Well, and you don't have to paddle. What slow. The Ethics consultation that he spent a lot of energy on and the first part of your presentation, where did you get that the Ethics infrastructure? Did I miss something? You talked about some of the ethical --
But where does the expertise come from? To you on that the employees that do the epics consultation, they part of your institute? To you have to go outside someplace to get it?
We haven't gone as side. We are dealing -- we haven't -- we looked at this as so inherent an intrinsic to the entire process that it is not something that is a separate process.
Just on that note and I think you again for explaining this in some detail. I certainly commend the desire to take accountability and responsibility for what you're doing. The thing that is absolutely imperative, but in that process it may actually require you to go outside and have some sort of oversights or ethics response from a group because you might need that perspective in order to be able to go to the public and say we have been accountable and are not just rely on ourselves.
This is part of the public consultation. We would like people to comment and our ethics people are involved in the oversight of various components of this as they are.
They are in most of our advisory bodies.
Again, is that the outside and this is?
It depends upon where they are. It depends upon which component.
All right. We had been having some earlier discussions about this idea of where do you go and how is it integrated. He looked like to have you looked at me like I was completely nuts.
Michael was that it would not be advisable as a separate activity.
All right. I'm sort of New going over the large pop activity where we sort of Hunt. We sort of thought about this issue of, do you have this activity above it that provides it. But that is fine. We will keep at it. Well, Linda, you are going to tell us something about I guess [ indiscernible ]. The -- he must have a role where you say either the first letter and the whole thing but you can't have combinations. The evaluation have to now make up the cases in practice. Your goal was to develop the cord and the process for evaluating to the test. In other getting indications that are in transition from pressures to critical and public health practice. Our first report on this was from William Torrey back in of five when the program was about a year old back in January of 05. We are very pleased that you are deeply involved in supporting the work and have agreed to provide an update on this important program. Thank you very much.
Thank you, and I want to think the community or in fighting as to come and provide an update on what is going on because a great deal has gone on since the last time I spoke with you. I feel like I should take off my hat and put on my guess at, but I am not as prepared. Just to give you a little bit of kaysix for those of you who aren't as familiar, it is a CTC funded pilot project that began on October of 2004. It is not a regulatory in its approach and is focused on an independent non federal multi disciplinary -- you have heard that word before today, working group. The goal is to integrate existing processes for evaluation and appraisal. We didn't want to start over. We want to take the balance budget to the task force and all of the other processes like the U.S. preventive Services Task Force and the community guide and see if we can come up with the methodology. Another important objective was to minimize conflicts of interest and essentially to develop and implement a edited and ultimately publicly accountable process. And this was the more updated version of the coal. That was our original planning goal you just read. It hasn't changed much, but to establish a systematic evidence based process for assessing genetic tests and other applications of to Numic technology in transition from Research to practice. It is important to throw the cost inside out, particularly where we are in debt methods are still under review and we are still in the process of development. We are starting to move into the product phase, but most of our products are not yet final. So what I'm doing here is prevented from CDC's perfected a perspective of their work in progress. The working group, as many of you know, was established in May of 2005 with 13 original members still there. I did put a list of the working group members and steering group members on the back of the hand out and was kind of horrified last night to notice that in the process of doing that I lost two of the working group members, and we don't like to lose them. So just to point out James and Carolyn Sue Richards are also very active members of this group. The group has met six times and we need for a day in a half in a form great much like the one you are sitting in. As I'm sure all of you can relate, they have had countless subcommittee teleconferences. They have three standing subcommittees' of topics methods and products. And in addition, to that each of the members sit on the topic specific groups that work on specific evidence reviews and some of them now are actually working on writing teams. Said they are very busy as I'm sure you can relate. The next meeting will be at the end of January into the seven. In terms of support we have relied Curry much in the first two years on an interagency agreement. That is so that their evidence based practice centers could connect five of the reviews that are part of this pilot project. In terms of staff and consultants the CBC national help to north I am located, we have a support staff there that works quite closely with the working group. We also have a number of technical consultants and contractors who work with us and our sisters were Janine account that is funded through CDC have also been very helpful in thinking about some of the stakeholder issues and talking with us about dissemination and translation of product. And in fact the University of Michigan center set up its takeover advisory group that started meeting a couple months ago. The steering committee and it is an inter agency many federal steering committee of the we have added some new members now was a group that was incredibly critical in the early development and was involved in many of the early planning discussions and certainly were totally important and involved in the selection of the working group members. We are now moving into sort of a next space. We went to a case where we went into reviews but hadn't have product.
I think we will be moving into the product face and are rejuvenating that group and have added some new members and replace some wonderful members to have rolled off the community. Allen was just a tremendous help in the beginning and Suzanne has since retired. But we are going to start meeting again quite intensively with this group to look at the review of where we are now and the processes and products. We want a lot of input on the evaluation phase which starts this spring. And really now that we have started to produce products and are getting a feel for this process we began to consider again how this becomes a sustainable process which any of you who know when Cory know that this is a very important part of this process. In terms of the scope of topics for the pilot Phase we decided not to try and take on the whole world of genetic testing but rather to try and focus a little bit and to begin with applications recognized as important or more. There are some examples there of test used in a clinical smell and screening tests but tests with a potential for a broader population application and therefore a broader public health impact. And also when they choose tasks they are also looking to maintain a portfolio of test that can challenge the methodologies they are trying to develop. So they have two main reasons for looking at them prior testing topics. The approach they are taking this early to start with the lessons from the this process -- and I use that acronym to mean a couple of things. Certainly from the task force on genetic testing which really laid out the analytic ability and clinical validity and ethical legal and social implications as components. And we are carrying on from the project which also did a formal assessment of analytical Quality and relevant ethical legal and social implications which is at least the analytical validity part has not really been a component of most evidence reduce up until this point. We are also still using questions to organized collection of information with a focus on attempting to synthesize the information and find out where the camps are. We are also integrating some existing evaluation processes. There are a number of I would say gold standards methods. And that is we started with reviews from evidence based practice centers because of their credibility and experience. We are using formal and the crane barge with key questions and express its strategies. We are assessing the quality of individual studies and the strength of evidence and providing recommendations with a clear linkage to the evidence which is really important for others to follow behind and see how they do the conclusions that the dead and obviously to identify the research agenda. I think they have tried to do some your things and that is because there is such pressure of these products and test building into clinical practice of quickly to attempt shorter-term produce that are targeted and practical and to focus on hard medical outcomes and morbidity and mortality but also to consider specific family or societal all comes were proper. Basically we look at these laws of modeling and have commissioned some modeling in a couple of the evidence reduce and it has become clearer and clearer as we move toward that will really be necessary to address cost effectiveness in a formal way as well. The products of the group are of the is the evidence reports that come from a chart to or from other contractors and some situations. They're is a peer review of the straps that is part of the process. When they are released they are posted on the map. The recommendation based on the evidence developed high being written by the working group. There will be peer review of the stress as well. We are planning publication and posting and what we are hoping for and situations whenever possible his concurrent publication of the in a summary one with the recommendations. And we have been talking with our friends at a genetic medicine who are very interested in working with us on this. Hubert be just to give you an idea of the topics in the pipeline right now and where the different topics are, there was an e PC evidence report released by 8RQA few weeks ago now. This particular topic was actually funded by CTC Division of Cancer Prevention and Control last for a partnership with the get to look at the results. It was more of a horizon's can I detesting for detection of over in cancer. And the working group is currently working on a draft recommendation working on tests. And that draft is an internal review. [ indiscernible ]. When draft reports testing for hereditary [ indiscernible ] cancer in a newly diagnosed for cancer patients and family members. This is a final de PC report in development. Their track review has been reviewed and has gone out for peer review and is now working on the final report. PTT one of one mutations in patients tended, this is a non each PC review that is quickly moving towards peer review as well. Topics recently selected, the impact of gene expression profiling tests on breast cancer out comes was awarded to the PC in late October and is under way. Screening for support for the polymorphisms to predict response to pain management with cutting, this is request for the proposal that is in development which will also be in the PC review. The use of profiling to assess risk for cardiovascular disease and identifying individual practice strategies is a review that is in planning currently. I think it is important to point out that the gap is not alone in this foreshore. It is one of the spectrum of non regulatory initiatives for translation and evaluation of to the test. And I think it is important to remember that all of these groups of money from the process is and all of this information really need to be collected and considered. Certainly the task force has done to reduce on genetic topics. PRC a testing and hereditary in the lab Telesis. There are a number of assistant groups working in the country. This is just to get in examples. The Blue Cross Blue shield Association Technical evaluation Center has done a couple of very nice piece. Intermountain Health Care is working on internal reviews using the rapid each format. You heard from this that program which is more of a translation program but certainly looks at some of the issues of translating and the quality of testing for these rare diseases. We had a very interesting meeting a few weeks ago on evidence based evaluation and decision processes for the it Library Committee and herbal disorders and to Ed sees in newborns and children. And I think there are a number of funded projects and I mentioned one I know about because it is CTC fund and which is genetic Alliance project on access to credible genetic resources network. I think the next steps are very much about maintaining momentum. It takes a lot of work to get a process like this started and to continue to use what we are learning from each review and will that into what we do for the next review. The working group is obviously spending a lot of time thinking about these issues. Publication of my the is and what has been learned of B.C. will be very important for the group to publish what their experience has been. Publication and dissemination of products, obviously we need to ensure that these evidence reports and recommendations are widely disseminated to professional organizations and health plans and a number of other groups. Initiating a project evaluation, we really need to know what is the value and the impact of these kinds of products and how they are being used and if they are reaching the folks we are trying to reach. So we are calling into an evaluation phase that will take a year and will adopt a lot of stakeholders. And then there is a step we feel is Curry important that I think will be very challenging, and that is the translation of the knowledge gained from the evidence report and recommendations into informational methods for a different target audiences and finding ways to appropriately get that information out. This is sort of a happy announcement. Working group is very comfortable with their relationship with the CDC, but has also made it very clear they want to emphasize their autonomy in terms of the decisions they are making for the recommendations. So one at the request the maid of CTC was an independent website. This turned out to be something more of a high hurdle than we anticipated, but we actually get formal ratification of the waiver of approval yesterday and said he should be able to get this contract would set up by the end of the year and got very excited about that because it will allow us to enhance attraction with stakeholders which has been more limited than we had hoped and will allow the working group to post topic lists and their methods and processes and evidence reports or likes to those reports as they come out of B.C. to post the recommendations and to post informational materials as they are developed. It will also allow the group to solicit feedback can to get input from sticklers on suggested topics for review. The web site will be coming Sen.
I think the real challenge that both the working group and the steering committee and CTC as well will be thinking about going into the next year is really how to build a sustainable process. Where do you go with it a process like this. Obviously we will on a lot about that is and what works and quality of information that exists and all of that. But I think there are other questions to be addressed and one certainly is the composition of the working group. Be have a very committed group for the pilot study and they have all stay with us. And this group was put together very much with a science book is the first year which was spent entirely thinking about methodology and approach is. And looking at a very dispassionate process that avoided pretty much any state of opposition from the embassy or criticism point of view. That as we move into a policy face their is need to think about the ball of consumers and industry and other folks in a group like this? Do we expand the scope of topic? Certainly the methods being developed could be used to look any kind of emerging technology. Right now we have been focused on the population based applications, but should that change? Should we go on and evaluate the Department of stakeholders who are focusing on health-care providers and Paris? Policy makers and consumers on this first round, should be moved out from that? And how do you support such a sustainable process? What is the will of the different health and human services agencies and public-private partnership. And then something we think is pretty important is the need for post market data collection process of some kind because we have pretty got to understand how these tests actually work out in the real world. So we think we have enough to do for awhile to keep this very busy scratching your head. And I can't tell you how many people it takes to do something like this. So I merely want to get a lot of appreciation to the working group. What a hard-working but they are. A wonderful partners, the people on the steering committee he had been great supporters. We test love them to death. And our centers or to damage and public health who really have also become very interested in this process. My wonderful stuff, we have a tremendous group of technical consultants. You can see there it includes the above Lynnette has done a tremendous amount of work for us and our technical contractors to we could not live without.
So now, so remember all the stuff we went through painfully about clinical validity? All right. So now you are -- show us how what you are doing relates to that activity and also does cap -- is capped the end users that you envision of the kind of stuff you are going to be producing? Because to me what you just presented is extremely optimistic making in my heart.
Mind to. I would like to point out we have a working member in the audience. Feel free to jump in. I think there are a couple of points that come to my mind relative to your question from what I have listened to for the last two days. One of them is that all of these groups, cap and a CMG and all the professional organizations and CLIA and FDA, everyone benefits from the information that is developed by a process like this. I did how they use it is going to be the interesting thing that we need to learn about. And how useful is the information? Are we getting to the right information and is it presented in ways that are useful? And we are really trying to take that practical approach. I know we spent a great deal of time talking about that. I think one of the things that -- and this is me talking now. The analytic validity is something that really seems to keep cropping up as this problem. And I think it is part of what every laboratory does, to do the basic foundation of the test. That it you think about the numbers that most of those labs are able to a generate and how wide the confidence intervals are and what they know about these tests, there is a need also for aggregate data, for someone to take a dispassionate look at cities from different groups and say, okay overall how well did these tests performed in practice? And then you get the critical liberty which is really the crux of the matter, are we getting to what we think we are getting to when we run these tests and how useful is that information and how will it impact management? And the and the outcomes for the patient and potentially in some cases their families. So I hope that we will -- they will be able to show where the gaps are with these different examples of we have chosen to test the methods. What does the data look like? What is the quality and how much it was out there? Where are the gaps? How they are they? Can they be easily resolved and are they really problematic? Those are the types of issues we are trying to get to.
Your other challenge will be scaled. That's just say this is wildly successful and at the end of the day how many of these but can you do and what are the economics? In is that be the legitimate role of government or are you proving a process that then gets reproduced? I think that will be really the --
Yes.
It is extremely important for you all to be widely successful. If you are successful think about all the hassle you take out of stuff moving from the to bedside and these kinds of things and speeding that up and giving analysis that everyone can use and you don't have to reproduce the wheel. Cut they could probably do like one a year.
Well, we have done for and 1 year. No, it is very challenging. I think something -- and job of it if you comment. One of the things that surprised me is there aren't as many topics were tests or new applications out there that are ready for review as you might think. And I think what we have to do is figure out how we prioritize this and then, to they all meet the same level of review? Do we need a comprehensive law on everything or can we do to review on seven counts of things that will be less apprehensive. These are questions we are looking at the town of the answers to.
Family? The king of the list of topics you are reviewing I imagine that but the process for some of these might say ready for prime time and some might say either not everyone to be ready, that your review basically concluded it was not suitable or that your review concluded there is not enough data yet to support it. And for that last category what do you envision as a review kind of thing? You say it is ready for prime time and at it by certain gaps, but then at some point you presumably would like to look at it again when some of those gaps have been filled.
I think that is one of the most challenging things we have talked about, how do we do that update process. Because while this group, I think -- and again job on me if I -- I'll take care. I think we are trying to the very practical and not just saying insufficient evidence and bring up their hands, but saying here is what we know right now and here is how that might be appropriately applied. Here are the gaps in here is potentially what could be done to resolve those gaps.
A la that this has been a learning experience and try to find the purchase of tests to the address and have a certain set of purges for this demonstration to try different methodologies and different types of tests. But going for what do we recommend from an ongoing process as to how to prioritize test and what to do about looking at things again as more information comes up. And we do think that one of the perhaps biggest thing we can contribute is to help but and but where the gaps are and how said the research agenda for around these issues. --
A guess and why to what read was testing. It you come up with not ready for prime time, but just needs more data, we really can't make a firm decision needs more data. At what point when there is hopefully more did it do you then turn around and read review that and say to FTA or whoever now this and allied use and this way is ready for prime time. It as a couple levity that is established. So anyone who wants to make it a sport that only has to be concerned about the illegal side of that rather than the clinical utility.
I think part of the process will have to include some mechanism either for continued review or some process by which a group could say, well, now this information has had some additional studies. Can you be look at it. I don't think there is going to be one process and the interval. It will vary from test test depending on what the information is needed.
I am just really encouraging you to try and when you put your Web set up think about how to give people guidance on that kind of a process as well. We are going to list five caps and at least three of them have been filtered studies we will look at it again to see if we are -- some kind of something for the things that are in the intermediate.
I am going to to a process to it. We will take one more question from Andrea and then I want to make a natural segue into balance that easily allow some of our members to exit. And we will have Sharon start to come up and talk about discrimination stuff. So those that are worried about having to flip out, don't worry. The chairman as of the ball. I got it. Miracle.
So much for being in control. I was just wondering how these topics I selected. You have this meeting and where you are having to come up with a different area our area. So you think the test must be ready for primetime. Again, the first set of topics that were selected were selected for either deliberately to test different methodologies and to fund clinical some areas. So it is not necessarily the method that would be going forward. We try to do initially a broad span from stakeholders as to what groups and individuals for what could be tests that are ready for prime time that would be useful to look at. We mix and match and give a number of different criteria including clinical some areas and how well developed the test was and how complicated the medical scenario was going to be and whether or not we thought there would be a lot of information rushes what you do when you have just it will bit of of commission and are there different kind of reviews. So we really tried to be thoughtful for the first topics to test different methodologies and different types of tests. Going forward I think that is a different issue as to how new test will need to be brought into the pipeline. As Reed says it is somewhat of a narrow pipe line.
I would strongly encourage you to seek public FIS from different sticklers and professional organizations. There might be something at the forefront might be more aware of.
We more likely to indicate over topics. Then the question that family had that maybe you can seek input with the specific metric maybe on when there is real data available for some of these things.
I have three minutes before the hour. By the way, that was terrific. That was a terrific way to do it. Three minutes and add to want to review, if we can get it on the screen by the way what you mess will be terrific but we can get it to you. With too much left what did we get down to a does want to repeat this caught up, Scott revise the report and recommendations based upon the input received on is to this session. Send revised recommendations for review prior to seeking public comment. London to seek input of 15 federal and not federal experts and State College on various issues. Seeking public comment on draft report and recommendations. Does this so far look like reality? Gene patenting and licensing practices, we will revise the city questions scope and timetable based on input received during this is section in a sheet review and public publication process. Does that seem like reality? Jim?
Jim your reality is on the board. You need to look real quick and make sure you don't disagree with those summaries as to what the tapes or gene patenting and licensing. The rise and come -- do you feel good?
Yes.
What is he going to say at this point? Oversight of gene test and testing laboratories in competition with new workers prepare a letter to the Secretary is pressing concerns about oversight. We will feature a case study illustrates rest to the public health due to current get some of it. They're is a work group which is appointed and will do that. We have consultations with private sector are in positions in New York state which we will work with and the interim. We have more guidance and folks may have some other things that will be flashing that out as we get to that meeting. Everybody seemed like it comport with reality? All right. Revise the report and recommendations based on input received during the morning session and develop conclusion an executive summary and circulate file report to Sese confirmation that the wording of the conclusion reflects today's issues and sense of the Committee for today's discussion, but the real deal that you voted for was to transmit the report to the secretary. So we will get it out the door no fooling around. Next? And lastly these are some of the areas that were being proposed for the March meeting. We have a large pop up to it. We have seen Spences and licensing practice session. Personalized a. We talked a lot about all that and to read an electronic data stuff and we will probably have something more formal on the next meeting. Oversight of informational session and? To be determined. We have the presentations again as we talked about and react. Also I think it must be involved in this discussion. Can we get a big drum roll? But was big. All right. Is the committee in the last 10 seconds comfortable? Are you all right? Do you feel like we got done what we need to get done and are you squared away for the interim? Terrific. For the three people only that are excused, the rest of you are not. This to give so everybody understands what is going on. We are going to be able to have for -- Joe, he's back in on this thing. Why are they all on that side? So thank you all very much. Now the least but not last or last but not least we do want to hear from share and carry on the status. You will have all kinds of insects because of the new Congress and your projections for kinds of new stock. After that we are done. This is a good way.
And this will take Route two minutes. So you don't have to worry. Of course as you all know things change with the November election. They were working toward getting the bill on the docket and on the bill before the November election. We do that because the chairman did put the bill fourth despite the fact that we are up to about 246 co-sponsors. So we have done a great job even though in other years we have to 60 which is mostly Democrats. But the change in the Congress comes a lot of changes over all with the bishop of the committees except for. We have what is called a lame-duck session. But had to predict how would say we had about a 10 percent chance of passing this bill during the session. So it is not put the dead. It is possible that Republicans what side they wanted to put this work are alive and well and very interested in being fairly conservative and a lot of business with insurance and that the future is not easy. So where I think some people may have naively thought that the house which leadership we would fell through, and I think we will still have a lot of work to do.
Other questions? This is terrific. Well, Sharon, keep at it. Don't get tired. I don't know whether to feel good or bad or nervous. We will just play it out. The floor is open for any last comments from the community?
I just want to say it is once again a pleasure to be here. And I encourage the secretary's staff to send all of the new Congress people coming to Washington and welcome to congress packet of the genetic discrimination pact that went to everyone else that was in Congress and the last session.
Well, so we have to ask the Secretary to do that, right? We can't do it. Okay. Actually, that is pretty cool. There are people here who can hear that. One of the things I do want to end up on -- is there anything else the community has? I too want to end up where we started. I wish you would take back again to HHS central into your colleagues at the secretary's office that we have duly noted on more than one occasion during the course of this meeting the interest on the part of HHS and the secretary's office that we haven't had before and we do hope that you all will continue to be attentive taking the ship and bringing our things back and given that so many of our interests are aligned, really alive right now. And I think the comment from the money was actually a pretty good one and a nice thing to do. So it would be a nice gesture to do that. So thank you. All right. Thank you all for a terrific two days. Appreciate it and see you next time. Thanks to the staff, my God. Terrific. Pop