institutions and teaching hospitals have to go through with consent forms to do anything with patient material interested in seeing your consent process these sali will look forward to you this afternoon. the other thing i will throw out not to distract is that genetic information ithe property of an indidual but the genetic information actually h@s can ship -- kinship your genome is related in some ways. but how far one of those with making one's genetic information available for democratization or

socialization, there is an ise ether you're close kin are being dragged into society without knowing it let alone consenting to it and i wonde whether anybody is thijking about that. .. first, greg's talk about the gao study from 2006. i think the field has evolved since then and would be nice if you guys could repeat the study in the current landscape here and i think some of the early companies that you have probably said he had ceased to exist. second comment with respect to e research endeavor, i think peop who join these kinds of research efforts are truly not reprentative of the underlying population. they're going to do well no

matter what. mean, we have done a clinical trial where we analyze people into receiving personalized information on the basis of their family history, versus receiving genetic public alth messages. and gues what? both groups did well by talking people alone, i think you cannot attrite, if people do well on the basis of being called that because they are not motivated enough and going to do more of the right things. and you can onlyttribute that to the intervention, which is the genome. it could be self-motivated and you need to subject these kinds of studies to the rigor of randomized clinical talk, which i hope and scerely hope that the business model of these companies would involve the. the third question directed to sandra, talked about, a i'm not an anthropologist. i playne otv but i am curious that a networking that is now clustering around genetic

>> can bridge the genetic cultural divide rather than create new types that are involved and forgetting that the factors and disease in general. i'm curious t see how the anthropology of the nature and nurture might evolve as we all cluster around the genic trades and we create new racial ethnic or other genome profiles. >> if you'd like to make a brief response. >> all right. so we're just starting some empirical work. i think your question about how genetic information can trump other sources of information. a of

genetic ancestry, in the sense that >> in the sense that peopde who may have lived their lives and identifying with a particular ethnic o racial group may see results and all of the sudden that challenges how they see themselves. i think it's important to do empirical work on how this is being taken up by individuals. >> i also think, the research hot button got to me as well. i think one of the isss that i see is whether there's going to be public or ivate fundi of research. t@is is what's happened to our clinical trials which is largely funded by pharmactical companies instead of by the governnt. the government doesn't have the resources to do that. we get trials that are direcd towards the question of the pharmaceutical company that wants answered as a major scientific question. and so on the back end when you are sring your specimens, that

going be peer reviewed and for the public good? again, the confusion for the altruistic volunteer is researching for us. whats the quality of that resear? rough there specimens being used for a cau gone through a peer review o says that the research is scientifically valid or if the benefits outweigh the harm. we have the experience with pharmacy data bases being sold with the electronic health record that couldn't have a viable financial model and instead gave the electronic records free to the doctorso use and on the back end sold the presigning practices of the doctor. i think it's not to sayhat you don't have good intentions but i think it's an issue of what kind of research are these specimens

going to be used for and what is the quality of the data. what will we be able to learn from that? >> yes, i'm going to go to the floor for the next two quesons. and ask each person who speaks if they would just briefly identify themselves. this is just fascinating material we are dealing with on the one hand the medical community is being cut out and unwilling potentially unwilling members of racial groups and families are being dragged in. there's a l of shifting and sifting going on. >> yeah, sandra, could you elaborate on your idea of create ing a common language of common knowledge that is formlating the concept and invade which has been transferred across the people. as you know we are still struggling wit the issue of two

cultures. and now we are faced with the idea of communicating between the biologist and genomeist. what are your practical ideas? what can we do to bridge that gap? >> i realize it's a big challenge. sot stanford we had a interdisciplinary dialogue. and so we had geneticist and other scholars in the se room trying to definehe concept of race. of course it was a heated discussion because there are different ways of approaching it. i think you can take this for many concepts that we now use in trying t translate genetic informatn. and i think, you know, one step is to have dialogue. but the next step is

transparency. revealing the kinds of assumptionshat different disciplines are bring to the table of the defining concepts. genetic ancestry maybe different than a person in the community. and it may mea iluding that pe of transparent language in the studies themselves in deciding how the are categoring and naming the research populations. that would be a first step, i think. >> i'm a genetic counselor. i teach genetics and social issues. i want to respond to what you just said. i understand why you feel the field has moved on since 2006. and i'm sure that list doesn't feel what she offs has anything in common with cats

claw. i think you have to realize that in fact legitimate information with legitate products haven't replaced more offerings of the internet. they coexist with them. and in fact if you want the general population to see the difference between the offering of cat's claw and the offering of more validated testing, then you're going to have to addss the exist of these things out there. they will taint the whole rest of the field. and i know the companies that were tested, many of them sti actually do exist, are offering the same products. and it haven't gone away. just other things have come in better and more interesting. the other thing that i think your presentation brought up for me is how easy it is to send in samples for other people as you did. now you said, oh, pain it would

be illegal now or whatever. i do some counseling for a genetic testing company. and routinely when i call up to the people and give them their results and we always do them for genetic counselors. routinely the person i'm tking to is the person who sent in the sample oh, it's my son or stepchd or my wife or whatever. and they are not trying to trick anybody. they don't really see that it's a problem. but i'm telling you it's very easy to do. i just wanted to bring that point up which i think you're talk raised sort of. >> thank you. i'd like to return to this what we were talking about before of the call of the innocent bystanders or third parties where the research project was

organized within a company or genetic networks occurred. it's the problem of w protects the third party? if you want to do it, okay. but i i also is in for me, i may be embarrassed by it. can we have a little bit of the attention to the discussion about the implications for others in the tribe or group with wm one is genetically affiliated? >> i just asked the question. i'm seeking help with -- i think we're seekingelp with all of the isss that we're raised. jonathan probably can deal with it. >> my son came back in third grade. this is back in the early

'90s. this was a player obvioly directed at his mother attending to the jewish women for the breast cancer trial. i thout that was interesting. that was the way i heard about that study was in his backpack. wish i had kept a picture of it now for my talks about it. so a few years later and many people know this sry. some of the data from those early studies ended up on anti-semitic web sites, i gather there a some increased risk for jewish women. is that true? so the point was y see they really are different. there really is something wrong with them. so i just take this as a comment on presentation. the groups stigmatization is

something we're going to have to think about. beyond the family to the way in which we think about who wre connected to in various ways. >> let me ask you group stigmatization is very important to mention. but turn it around. what about the power or right legitimate of a groups attempt to preclude an individual's participation in one of the exercises that sandra describes to me. that also is a possibility. >> it's a reality actually because there is a moratium on genetic testingn america indian tribes now because of just that. and so they obviously have different stus than other grps don terms of nation steps.

bqt i think, you know, your question is legitimate in the sense that should we have group cknsent? i mean we've kind of -- >> so let me describe that. you say there's a moratorium on to the testing in native american tribes. i am aware what if an individual in a tribe wants to participate and insists. do you know of any instance where the individual has insists and even gone as f as an individual saying it's their rit, whatever statutory or constitutional other basis to participant that that's one of their individual rights. have yo heard inny instances? or anyone? >> i haven't. >> i could speako that just a little bit. over the last ten years, and you'll hear a little bit this afternoon, data s up from 108,000 people throughout the

world. we've run into this problem a number of times. we doave a number of native americans that are in our data set. they have all been individually opted in, essentially. and in none of these cases has it been challenged. where we e looked to see whether t tribe would challenge it. they felt it was up to the individual to make that decision in these cases. >> but this is a much more general question than the genetic -- single genetic testing question. we do not have good oversight mechanisms for the benefit of thinking abo group harm of many research procts. and it's coming up in community-based participatory

research. we don't have good regulations or oversight o common rule doesn't address it. so this is something that i think we have to taken proactively as an issue well beyond the genetic. >> it's much broader than geneticoo. p any own area of wk, environmental law in part, the stigma attached to persons living who have drunk the water or breathed the air in your site for a generation or so and they feel like they have -- they are tainted by that community experience and resrchers and others wt to address their situations. and that leads you to the same problem. it has nothing to do with genetics. >> i do want to go back to one comment that you made, tim, in passes.

the uk is now protectg t ability of parents to enlist their children for genetic testing and that that should, one mu wait -- one must wait til they are at an age of consent. and that its heah is at the protection that i think we would do well to think about on this side on the atlantic. >> it's called a statutory requirement. it's a review, it's expressed. and the discussion about the way that other individuals might be affected by a particular genetic test we are not familiar with this sort of group aspect of it. but i think it's important to distinguish between the single gene disorders and the more the

y snips bitch is more what the testing companies are familiar with and arearrying out. so for single gene disorders, clearly if one individual in a family from a genetic counselors will attesto this and are familiar with it, i think they are dealing with it. if one family member in the context which is often quoted exple, is found to have or be a carrier of the diseased gene, then that has clear impact on the family members who may or may not want to know. and the protectiothat is afforded by genome or other legislive implements is very important for them. i think for the children for testing the single gene disorders, the view that i've heard clinical geneticist saying is if there is no treatment that is availability, then there is

no reason for the child to be tested until they have the ability to make that consent for themselves. i think that clinical yes nettist apply the same argument. now i view those two situation as being completely different. and i recall having to do that for a certain project for a gene expression microdatabase. and the riew board completely misunderstood what we were wanting to store information for. and they treated this information which was just gene expression data as being a serious and gorrying as the single gene disorder. i think there's a misunderstanding here. i think as far as theenetic tesping for direct consuming as the children are concerned, the recoendation is that children

should be able to make up their own minds. so, for example, if we view this as an adventurehich he suggested that we don't know where it's going to end, and the routine sequences might become the norm if it was available for the 1000 of g.i.n.a. and should that parents be allowed to genetically test them. i think i would subscri to the genecist vie they need to wait for the children to make up eir mind. >> i any one of the things that has made them unique is from day one, we @id not test minors. we felt very strongly against offering this type of testing to minors especially for all

adult-onset diseases. and theifferent types of conditions and ages of onset, i've had a number of parents and physicians say why can't i? i want to know about the risk and breast cancers and questions about ifferentype of risk factors about weight in different points of age. how do you start to think about a construct for rolling out genetic information across the life cycle? this is something that we're actively tnking about while maininin that you cannot test minors for the types of information we're currently testing for. we're starting to investigate some sort of ideally public, private collaboration to start to investigate at what point is a relevant and aropriate and what does it look like? is it an consent process?

i phink there are loot of complex questions around that that need to be addressed. but we don't proport to have figured out at this stage. the second thing is getting back to david's onlial question around when you have this information that it is genetic, it is inherently going to impact family members and groups. you ow, traditionally around any kind of monojettic -- monogenetic testing, while i think this is no different in the sense of how we inherent these different markersf talking about common comex disease markers, the real difference and struggle that we have is with the general consumer/client patient understanding of complex disease risk and trying to explain that because while we were -- and to them it's genetic. and si think it really is a

struggle to try to say, well we were talking about dozens of different workers. you c't really figure out the probability of what that means for your children. it really does become more of that individual needs to test themselves to understand the impact of that family informationnd having that discussion? >> going back to the question asked from the floor about genetics couelor about the sourcing of samples. i mean does your comny or other companies address the issue of what we lasyers called chain of custody issue? do you require a statement? is it sworn? what is the nature of the custodial chain between the dna submitted and the individual who submits it? is tre any constrain on my submitting anyoe's dna that i might want to? not just ascustomer, but your dna mightome from elsewhere?

>> in terms of the system that we have set up, an individual who consents is consents to have their own dna and they are representing themselves. i know not everybody approache it that way, that's how we have. >> suppose they are not. how do you know? >> you don't. and so that' part of your opting int essentially a legal agreement through terms and conditions and csent. but there really isn't a way to prove that. although, we don't believe that it has been such an iss to date. some people do test privately. there wouldn't be a way to check that anyway. >> can i ask one question and make one comment. the comment is akin to others that i've made. that my understanding of where the field is is that the importance of clinical phenotyping is deemed essential

to making sense of these variations. that's not atrivial thing. and it usually takes an intermediary who happens to be a health provirs who is able to do the kind of accurateetailed assessment with a patient at hand. when the company's talk about collecting the database and addhng all this information about the contributors of the dna, it seems to be a disconnect there between where the academic community sits on this and where the companies sit? that's the comment. the comment i had is fundamenta i just don't know the answer. professor aitman, is there any information at all about the frequency of which an array of

snips from me would be found in my kin that is the cosegregati is it or what is it? bu is it likely that the array for me would be entirely different from that of my for or brothe or children? >> if you have 1 million snips, it will be uniqu to you. the nnly other person would be an identical twin. and so it's more -- well, it's at least as perful as dna forensic fingerprinting. and if no one else had access to some of your snips, they aould identify you as being part of another pool or database. to so -- so it raises the

question that we have about another individual. you don't need to know someone's name in order to be able to identify them. i think it is a little risk proverse to take that view. you don't have their snips in the first place, but you couldn' identify them. if you have a small number of snips, you would be able to identify them from a large group of individuals. because ty are unique to you. >> the problem of identifying third parties isn't completely new in medicine. doctors have been hearing at other people taking a psychiatric history. there's nothing new under the son. this is technical. maybe w shouldn't mystify it. ere's a good case to be made that private companies do have an obligation, an affirmative obligation to do research given the fact that they are doing a lot of data committed by their

entitied. so i clearly -- we shouldn't go into the presumption that we shldn't. thers a good argument to be made that they should. >> we can't leave this session without knowing what's happened since 2006 to your report. it was presented presubly to the congress and then -- >> well, we certainly have gotten a lot of phone calls and a lot of interest from people that are in this field. and there's no documentary being done, i've been interviewed on these issues. we haven't done anything updated that's going to be published. just lots of interest on capitol hill. there was a fda, fdc consumer alert issued on the same day i testified on this before the aging committee warning consumers about this and educational information. that was really the result.

no other legislative initiatives at this point. >> what's illegal? >> which part? >> why don't you tell us which parts re illegal? >> we do illegal parts all the time. it's authorized illegal activity that you can make false statements. >> again we do referrals. we may have referred some of ese ases to law enforcement. these procts that were marketed to us,hey were multivitamins. and they were expensive. i'm not sure if it was illegal what gas being affiliated, but the marketing, on their part, and linking the vitamins to the profile implying that if you take these you reduce your risk of getting cancer and these othe types of conditions. >>