Rebecca B. Bacon writes:
>Would like to know if other institutions require a complete full Board
>review of previously approved research at set intervals. That is, a
>protocol is reviewed by full Board, has its annual review (at whatever
>interval is deemed appropriate) and this process goes on for "X" number
>of years. During this process, amendments are made and consents are
>revised. Do other IRB's require a re-review of the protocol and
>subsequent amendments at a set interval...for example every 5 years? I
>realize it's the Chairman's responsibility or his designee to ensure a
>review takes place during all the years the protocol is open. The
>question was raised at our IRB meeting today. Discussion took place because
>we have open protocols dating to the early 1980's. Does nayone have a firm
>policy pertaining to this issue?
If I'm not mistaken, this is precisely the topic of OPRR's Jan '95 guidance
memorandum. OPRR is stating that continuing reviews, even for projects that
have no mods or amends, must receive a "substantive annual review". What
exactly is meant by "substantive" is open to some question. Our IRB was about
to move toward the equivalent of a mini-full board review, but, as we thought
about it, annual review by a sub-committee w/ a report to the full board
and formal designation in the minutes, should qualify as "substantive". So
that is the direction we are heading. Mods and amends require full board
review if they are for projects that rec'd full board approval, AOT projects
that rec'd expedited review.
Len
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Leonard P. Paplauskas Assistant Vice President for Research |
203-679-3173 University of Connecticut Health Center |
FAX 679-2670 Farmington, CT 06030-5355 |
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