--- Subject: clinical trials and genetic privacy Date: Fri, 6 Dec 2002 09:55:33 -0600 From: deleted To: <declanat_private> Declan: I don't know whether this would be something you would be willing to have addressed on Politech or not ... but I would appreciate it if you would post this. Here's the deal: I have several children, one of whom was recently diagnosed with a serious, life-long autoimmune disease with both genetic and environmental precursors. Which one isn't important, but suffice it to say that it is incurable, chronic, costly, and disruptive of the lives of those suffering from it, and that medical science doesn't know very much about the disease process. There have been several breakthroughs lately, however, in which scientists have identified some genetic markers that, when present, predispose those possessing them to eventually developing the condition. They are only predispositive, however, not a certainty; why some people possessing these alleles go on to develop the autoimmunity (and hence the disease) while others don't remains a mystery, although there are no shortage of plausible theories. Our family has been asked to participate in a clinical trial in which blood samples would be drawn from my wife and myself, as well as the children, for the purpose of detecting the presence of the predispositive genetic markers, as well as the auto-antibodies that are the proximate cause of the disease. Based on these results, each of us would then be assigned a number describing the statistical risk of eventually developing the disease. Participation in subsequent aspects of the trial would depend on these risk scores. To participate, we would have to sign a standard consent form, one part of which states that our blood samples would "be stored, coded to protect [our] identit[ies], and that [our] identit[ies] will not be disclosed to anyone without [our] permission, *except when required by law*" (emphasis added). My question is this: under what circumstances could disclosure be required by law? In other words, are we talking only in extraordinary circumstances, such as a lawsuit in which we could be represented by counsel and contest the disclosure? Or would interns at NIH (the funding organization) be able to look this stuff up and (in the worst-case scenario) post it on the internet? And who (or what entities or organizations) could force disclosure without our consent, and why? The main reason I can see for wanting to prevent such disclosure has to do with our ability to obtain health, disability, life, and long-term care insurance in the future. My wife and I want very much to do whatever we can to contribute to the fight against this awful disease, but not if it means we would be potentially sacrificing our, or our children's, future welfare. It is my hope that some of your readers with legal training might be able to answer these questions for me. For obvious reasons, I would prefer that you delete all identifying information from this letter if you decide to post it, and sign me A Concerned Father. ------------------------------------------------------------------------- POLITECH -- Declan McCullagh's politics and technology mailing list You may redistribute this message freely if you include this notice. To subscribe to Politech: http://www.politechbot.com/info/subscribe.html This message is archived at http://www.politechbot.com/ Declan McCullagh's photographs are at http://www.mccullagh.org/ ------------------------------------------------------------------------- Like Politech? Make a donation here: http://www.politechbot.com/donate/ Recent CNET News.com articles: http://news.search.com/search?q=declan -------------------------------------------------------------------------
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