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Re: Human Subjects Len Paplauskas 17 Feb 1995 07:18 EST

>I would be interested in knowing (respond to the list or me directly -- I'll
>tally and post to the list)
>        institution name

 UCONN Health Center

>        approximate number of human research (IRB) protocols reviewed annually
>        professional FTEs (positions) devoted to administering IRB matters
>(yes, I'm also looking at staffing loads)

 ~600 active protocols ($42M research pgm)
 ~250 new protocols/year
 1 prof FTE, .5 clerical fte

>        review as proposals or later (if later, when?)
>        if later, could you send me your Assurance or procedures describing
>how you handle it?

 We review at various stages in the cycle.  If federal/private research
 sponsor that requires a formal proposal, then we review at proposal
 stage.  Obviously PHS requires IRB approval within 90 days of proposal
 submission.  For others, like clinical trials, we often get IRB app
 almost at the time the study is ready to commence.

>        how do you deal with IRB approvals for subcontracts you issue or when
>you are a subcontractor yourself?

 We accept the IRB approval of a subcontractor (for the sub's piece
 of the work only), provided the sub has an approved MPA.  If no MPA
 we do the 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               |
                                                                   |
xxxxxx@sun.uchc.edu                                            |
xxxxxx@neuron.uchc.edu                                           |
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