MIT, Quaker & Informed Consent

[David Scherer <scherer@uiuc.edu>]

Radsafers:

There seems to be some confusion about the concept of informed consent in
human research.  This is not a new requirement, as some have suggested.  It
had its genesis in the Nuremburgh Trials after the second world war.
Basically, anyone who is the subject of human experiments must be informed
what will will be done to them and what the likely consequences are.  This
information must be given in terms that the subject can understand (i.e. no
jargon) and they must be given an opportunity to ask questions.  They may
consent to participate in the research only after they have been so
informed and they may terminate participation at any time.  Informed
consent is required whether there is a grave health risk or not.  I believe
it is required even for purely observational studies (e.g., watching
someone sleep) involving no risk at all.  Some institutions apply it to
retrospective studies of a patient's medical record!

As Juan and Ruth have observed, things have  changed since the 50's.  Now
the requirement for informed consent is now applied to medical care as well
as research.  If the risks are grave (whatever that means) the consent must
be in writing.  As Peter mentioned, in research essentially all informed
consent must be in writing (regardless of the level of risk).  There are a
few recognized exceptions that could warrant a waiver, though (e.g.
obtaining consent would alter the results, no added risk).  These must be
granted prosepectively by the Institutional Review Board.

In the MIT/Quaker case, it does not matter that the tracers were used to
study digestion, not radiation effects.  The subjects (or in this case,
their parents) had a right to know and choose freely whether to
participate.  Informed consent is a specific, technical requirement for
human research and medical care.  It does not apply to anything you might
discover in the course of life (e.g. radon).  However, it might be worth
the effort to disclose what you know about your water to those who supply it

Regards,
Dave Scherer
scherer@uiuc.edu