>Here we have a spot on the IRB form for an exemption from full IRB review
>for the following reasons:
>
> (b,1) research involves "normal educational practices in an
> educational setting
> (b,2) research involves "the use of educational tests (cognitive,
> diagnostic, aptitude achievement(, survey procedures or
> observation on public behavior" and anonymity of participants
> is assured
> (b,4) data are publicly available
> (b,5) examines "public benefit or service programs"
>
>(At one point I assume there was a (b,3) but no one really knows what it
>was.) Anyway, the forms still have to be filled out if you claim an
>exemption but it does not have to go before the full IRB. Instead it is
>reviewed by an appointed IRB representative in the department. This person
>reads through the proposal...
>
>
>One thing I'm curious about is where these exemptions actually came from...
>... does someone have a fuller explanation of what qualifies for the above
>>exemptions?
>
>- Marc
Marc,
I believe your IRB form contains an abbreviated version of the "exempt from
review" criteria which actually come from the Office for Protection from
Research Risks (OPRR) of the National Institutes of Health. The full set of
criteria can be found at;
http://grants.nih.gov/grants/oprr/humansubjects/45cfr46.htm
and are identified in 45 CFR 46.101(b)(1)-(6). I also have an OPRR Report
update in my records (as our Institution's IRB chair) that came out in May
1995 to assist IRB Chairs in interpreting the term "Exempt" which includes
these criteria. It also indicates that "Institutions and IRBs may not
create new categories of exempt research under 45 CFR Part 46." and that
"Institutions should have a clear policy in place on who shall determine
what research is exempt under 46.101(b)." This report further states that "
OPRR advises that investigators should not have the authority to make an
independent determination that research involving human subjects is exempt
and should be cautioned to check with the IRB or other designated
authorities concerning the status of proposed research or changes in
ongoing research." We include the full text of exempt criteria on our IRB
forms and I am the individual at our institution (as IRB chair) that
determines exempt status.
Hope this helps.
George
George D. Goedel
Professor & Chairperson
Department of Psychology
Northern Kentucky University
Highland Hts., KY 41099-2000
(859) 572-5574
fax (859) 572-6085
[EMAIL PROTECTED]
