FC: Query from a father about genetic privacy and clinical trials

[Declan McCullagh <declan () well com>]

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Subject: clinical trials and genetic privacy
Date: Fri, 6 Dec 2002 09:55:33 -0600
From: deleted
To: <declan () well com>

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.




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