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Re: Human Subjects question MDaniel@xxxxxx 20 Jan 1999 09:49 EST

Franci,

this question has come up in the IRB Discussion forum in the past, and
there
were several good responses regarding the issues to take into account. I
was
able to retrieve at least one discussion from the archives but was unable
to
reproduce it here in this message. I will try to summarize the issues:

The group emphasized the need for a consent form, even though the PI is
using a
sample of his/her own blood. (Keep in mind that the researcher in this case
would be a research subject, entitled to compensation per your
institution's
policy if there is an injury.) Other issues include who is drawing the
blood? Is
that person trained in using aseptic technique? Does the protocol call for
only
one blood draw? If more than one draw is contemplated, then how often can
the PI
be a subject for this purpose?

If you would like to consult the MCWIRB IRB Discussion Forum , start at the
 web
site http://www.mcw.edu/mcwirb/index.html and follow the instructions to
subscribe.

Hope this was helpful.

Molly Daniel
Grants Specialist
Planning Dept.
Sarah Bush Lincoln Health System
Mattoon, IL 61938-0372
email: xxxxxx@sblhs.org
voice: 217-258-2195
fax: 217-258-2288
===============

If a PI plans to use a sample of his own blood in a research project, is
that considered a "human subjects project" for which we need to check YES
on
the NIH cover page?
Frances Vinal Farnsworth
Coordinator of Sponsored Research
Munford House
MIDDLEBURY COLLEGE
Middlebury, VT 05753
Tel:  802-443-5889
Fax: 802-443-2081
email:  xxxxxx@middlebury.edu

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