Genome Sequencing - II: Presidential Commission for the Study of Bioethical Issues Meeting 8, February 2, 2012

Meeting 8 Session 2  Privacy I: Privacy and the public good

Transcript 

George J. Annas, J.D., M.P.H.

George Annas, J.D., M.P.H., Chair, Health Law, Bioethics & Human Rights, William Fairfield Warren Distinguished Professor, Boston University School of Public Health likened the present state of genomic medicine to two movies: "One is Bill Murray's "Groundhog Day", [that] took an insight, a values insight, for him to get out of that day, and the other is his movie "Lost in Translation", which I think it's fair to say, without getting carried away, a lot of genetics is."

G.J. Annas presentation slide

He drew a parallel between genetic privacy and privacy on social networks -- the latter as described in Lori Andrews' book, "I Know Who You Are and I Saw What You Did."  He noted that many people are not concerned about signing releases for the collection and use of their genomic data by others -- as long as it is described as their "medical record,"  and yet object if what they are asked to release is "their genome."  And of course, very little is known about how that data might be used in the future. 

Mark A. Rothstein, J.D.

Mark A. Rothstein, J.D., Herbert F. Boehl Chair of Law and Medicine, University of Louisville School of Medicine was the second speaker of the session. Areas of concern he delineated were as follows:

• Genomic information in electronic health records may be accessed by healthcare providers without a need to know
• What to do in the research uses of the information

• De-identify it (public surveys have shown great unhappiness with this practice)
• Provision for opting out (many don't exercise that option -- but if you ask, often people are happy to consent)
• Opt-in provision (which researchers find burdensome to implement)
• Non-medical uses of genomic information, without consent or authorization (as required for public health for example - victims of abuse, neglect or domestic violence)
• Compelled authorizations by third parties (as a condition of employment for example)

In follow-up questions, the Personal Genomes Project in Boston was mentioned as an example of present work. The PGP is recruiting several hundred-thousand individuals, whose biobanked genome sequence one day will be made publicly available -- with all of them having consented to that. The question was raised as to whether there ought to be simply consent by individuals or also "social consent" to, or state control of such projects.

By way of exploring social consent in genome research, the National Human Genome Research Institute is sponsoring a clinical trial entitled Informed Consent for Whole Genome Sequencing: Ideals and Norms Referenced by Early Participants. 

In the detailed description, it is stated: "This proposed study approaches both informed consent and genomic medicine as iterative constructs shaped by civic values and social norms."

Understanding the civic and social contexts where informed consent takes place is crucial in order to adapt it to new realities in genomic research."

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Meeting 8 Session 3 Privacy II – Control, Access and Human Genome Sequence Data

Transcript

Jane Kaye, D.Phil., L.L.B.

Jane Kaye, D.Phil., L.L.B., Director of the Centre for Law, Health and Emerging Technologies (HeLEX), Oxford University spoke on biobanking and privacy.

While traditionally consent is seen as a one-time, individual transaction between the subject and the researcher, Dr. Kaye countered "...what has been suggested and what is used within bio-banking is a broad consent..." 

She went on to say "The second plank of medical research ethics, which is actually challenged by global data sharing is that participants should be able to withdraw from research at any time, and withdrawal cannot be promised when data and samples are shared widely."

J.Kaye presentation slide

She summed up the problem: "...as my colleague Eric Meslin said, it's a bit like Hotel California, you can check out you any time you like, but you can never leave."

Dr. Kaye concluded by suggesting a change in thinking to see it as a process of forming partnerships with tissue donors. In her view attempting to anonymize donor data is not as important as paying attention to the public preference to be asked about any uses of their data.

John Wilbanks

John Wilbanks, Founder of Consent to Research and Senior Fellow, Kauffman Foundation, among other positions, spoke on the question of privacy from a Web perspective.  He frames it as “…more a debate about agency, which is the right to decide what is done with my data and the right to see a copy of what people know about me.”  He pointed out that communities on the Web like PatientsLikeMe.org, with over 100,000 people, are generating studies with no connection to IRBs, such as one being done by ALS patients looking at the use of lithium.

He mentioned more ‘do-it-yourself’ Web projects, such as OpenSNP  -- pronounced Open Snip... a website, that would let anyone upload their 23andMe file and let people start attaching papers and annotations to the Snips.  It has zero connection to bioethics in the professional sense.”

J.Wilbanks presentation slide

He also spoke of a project he is involved in, Sage Bionetworks,  which is an attempt to create a “commons” for genome sequences that would help to build “predictive computational disease models” which do not involve patenting.  

The question of consent for the use of individuals’ data has arisen here and through his work with Consent to Research and Sage Bionetworks he is now seeking to develop a web model of consent that would be acceptable to IRBs and thus would encourage researchers to take advantage of a large number of personal DNA genome profiles. He calls it the Portable Legal Consent for Genomics Research, the about-to-be-launched project is described by Erica Check Hayden in Nature News.

A lengthy discussion ensued, with Commission members and members of the public exploring the contrast between the socially-cooperative nature of Web-based genomics projects and the fear of losing control of one’s own personal data – which it was pointed out, is not intellectual property in a legal sense, but rather, as John Wilbanks suggested, a kind of individual "trade secret."

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