Although I have never heard of this procedure before, I think it raises an
interesting issue worth discussion. I repeatedly instill in my students, as
they complete IRB research protocols, that failing to respond to a letter
does not imply consent. As an example, is it proper for a researcher to
send a letter to a parent "informing them that they would like their child
to participate in a study," and to conclude the letter with a statement
saying "please contact me if you do not want your child to participate"?
>From my perspective it is entirely inappropriate to make such an assumption
(regardless of the addition issues of including minors), and I don't see
much of a difference between this and "communicating to the community." I
suppose one can begin to make arguments about the right of the relative to
withdraw the person from the study, but I would be very concerned about this
procedure, especially if there is not a very clear and very high level of
benefit with corresponding low levels of risk.
Rob Flint
-------------------------------------------------------------
Robert W. Flint, Jr., Ph.D.
The College of Saint Rose
Department of Psychology
432 Western Avenue
Albany, NY 12203-1490
Office: 518-458-5379
Lab: 518-454-2102
Fax: 518-458-5446
Behavioral Neuroscience Homepage:
http://academic.strose.edu/academic/flintr/
Department of Psychology Homepage:
http://academic.strose.edu/academic/psychology/index.htm
> -----Original Message-----
> From: Paul Smith [mailto:[EMAIL PROTECTED]]
> Sent: Wednesday, February 28, 2001 3:37 PM
> To: '[EMAIL PROTECTED]'
> Subject: RE: Its up to the Individual IRB
>
>
> In a related area...
>
> Last Thursday's NYTimes carried an article about a study of the
> effectiveness of chilling the body on treatment of head trauma
> cases. About
> half of the article was about the special form of consent used in
> the study.
> Because it was not possible to get consent in advance (not
> knowing who would
> suffer head trauma) nor from relatives quickly enough after the
> trauma to be
> of help to the study, consent followed a new rule that has apparently been
> in place for several years. The rule allows assumption of consent
> (my words,
> not theirs...) on two conditions. First, the nature of the study and the
> assumption of consent must be communicated to "the community", and second,
> the relatives must be permitted to withdraw the subject from the study
> immediately once they've learned of the participation. The article noted
> that only happened in one case.
>
> I'd never heard of this before (it wasn't discussed on TIPS and I
> just deleted my way right past it, I hope...), and neither had several
> others with whom I talked at MIToP last weekend. Most were
> curious about how
> you'd go about "informing the community" (a point that was raised in the
> article as well). Sure enough, Sunday evening a doctor appeared
> on one of my
> local television stations to "inform the community" about a study of heart
> attack victims that will take place in my area.
>
> Has this been common, and I'm only just now noticing it?
>
> Paul Smith
> Alverno College
> Milwaukee
>
