Email list hosting service & mailing list manager


Re: IRB Policy question Dawn Dowling 15 Feb 2006 16:26 EST

Dear Deborah,

We do not treat undergrad research different than any other research.
NIH describes research as a systematic investigation, including research
development, testing and evaluation, designed to develop or contribute
to generalizable knowledge. If undergraduates are doing research - not
work for a class grade - the IRB would review the IRB protocol. The
application would be triaged and the level of review would be
determined. I would assume that undergrad research would probably be
less than minimal risk to the participant (although not always).  We
have an expedited review process that isn't too cumbersome and would ask
for a faculty advisor to be listed on the application. Our IRB expedited
reviews are done continuously throughout the month. Usually these types
of students come to my office and we talk about their study and what
they need to do (training, completing the forms, and the review process
- sometimes helping them remember to minimize the risks and increase the
benefits).

Bottom line is that the undergraduate research would be reviewed the
same as any other research (regardless of funding) - this is according
to our FWA as well as CFR 45 Part 46
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

I wouldn't treat the research different from other research unless you
have described it in your FWA.

Regards,
Dawn

--
Dawn Dowling, CIP
Regulatory Compliance Administration
Carnegie Mellon University
5000 Forbes Avenue
Warner Hall, Room 414
Pittsburgh, PA 15213
Voice: 412-268-1901
Fax: 412-268-6279
xxxxxx@cmu.edu
http://www.cmu.edu/provost/spon-res/compliance/compliance.htm

Deborah Hofer wrote:

 > Esteemed colleagues,
 > Quick questions.
 >
 > I am the grants administrator in a PUI who works the pre-award side
 > and administers both the IRB and IACUC.
 >
 > Our current IRB policy is to review undergraduate student research
 > protocols (primarily in the behavioral and social sciences) if the
 > results will be presented in a public forum, i.e., capstone
 > presentations to which the community is invited. This is low
 > risk, primarily survey based intervention and typically not supported
 > by federal grant funds. I'd like to get a feel for how other
 > institutions deal with this.
 >
 > Do you review undergrad research?
 > Do you have a separate process or policy governing this type of
 > research? Any experience or recommendations you can share?
 >
 > Many thanks.
 >
 >
 > Deborah d'Este Hofer MM
 > Grants Administrator
 > Southern Oregon University
 > 541.552.8662
 > fax 541.552.6115
 > xxxxxx@sou.edu <mailto:xxxxxx@sou.edu>
 >
 > "Only those who respect others can be of real use to them." Albert
 > Schweitzer
 >

======================================================================
 Instructions on how to use the RESADM-L Mailing List, including
 subscription information and a web-searchable archive, are available
 via our web site at http://www.hrinet.org (click on "Listserv Lists")
======================================================================