Summary -- Human Subjects Review Celia Walker 22 Feb 1995 18:38 EST
Response summary re Human Subjects campus practices -- 18 responses. __________________________________________ Applicable Federal regulations appear at 45 CFR 46 for PHS and the equivalent sections for the 17 agencies under the Common Rule, and we know what NIH allows -- the question was, how is YOUR CAMPUS implementing that for all projects? ___________________________________________ Colorado State University: 1.0 professional FTE, 1.0 clerical, 323 human, 520 animal, 144 biosafety protocols/year, student and faculty research. Policy is to review all at proposal stage. Typically review here regardless of subcontracting, but case-by- case may accept sub's or prime's IRB. Evidence of approval from another IRB required. U of Vermont: review as proposal Princeton: .15 FTE "secretary of IRB", .3 FTE assistant. Subcontractors provide approvals and local IRB reviews Mississippi State: over 300 protocols/year, no exemptions, student and faculty research. Reviewed as proposals if the sponsor requires, otherwise at the time of award notification with no account numbers issued until IRB approval obtained. IRB approvals for subcontracts are "individual basis;" comply with prime's requirements if MSU is subcontractor. Middlebury: 1 federal submission needing IRB approval in 6 years. No MPA. Have relied on prime's IRB for a few subcontracts. U of Wisconsin-Milwaukee: 120/year, 0.5 FTE coordinator, 0.5 clerical, uses former IRB coordinator as "complaint person" 1 hr/week. Review as proposals. UWM IRB reviews all protocols, regardless of subcontract status. College of Charleston, SC: $2.5 volume, 30-40/year, 1.0 FTE professional handling all compliance, pre-award and some post- award. Review at proposal. Review if subcontractor; expect subs to review theirs, but suspects C of C's IRB would want to be informed. Cooper Hospital/University Medical Center, Camden NJ: 200 new /year, 400 active, $17M total research, 1.0 FTE professional. Review at proposal. Review if subcontractor; expect subs to review theirs. U of Arkansas, Fayetteville: Review as proposals. U of Connecticut Health Center: 200 new/year, 600 active. 1.0 FTE professional, .5 clerical. If federal/private sponsor requires formal proposal, reviewed at proposal. Others, like clinical trials, might be later but before commencement. Expect subs to review if sub has approved MPA; if no MPA, UCONN reviews. U of Georgia: 1000/year (15% exempt, 5-10 full review, rest expedites). 1.0 Chairperson of IRB, 1 senior administrative secretary, + board members. Review as proposals. If UGA researcher carries out research, UGA reviews, has sub submit approval for its portion of research. Middle Tennessee State University, Murfreesboro: Director of Sponsored Programs serves ex-officio for IRB and IACUC, but no FTE staff assigned. Review at proposal. Eastern Virginia Medical School: 326/yr, .25 Director of Office of Research, 1.0 admin assistant. Review as proposals unless sponsor allows later review (prior to award). Expect subs to review theirs. Northern Arizona University: Review as proposals. Subs expected to review theirs. NAU doesn't accept another institution's review in lieu of NAU's. Old Dominion University: 1-2 full, 30-40 expedited, 10-20 exempt/year. "Common practice is to have review within 60 days of proposal submission." "Sponsor makes the call as to whether one or both institutions review the protocol" in subcontract arrangements. U of Hawaii: 350-400/year. .5 FTE professional, 1.0 clerical. Review at proposal. Accept sub's IRB if it is at the location where human subjects will be studied and if it has an OPRR Assurance -- evidence of approval is required by UH. U of Minnesota: 5000 active projects from all campuses. 7.0 FTE professional, 1 temporary computer person. Review at proposal. IRB reviews all, regardless of source or routing of funding. Lehigh University: 70-80/year, rising to 100/year, .25 FTE professional, .25 clerical. No MPA. Review at proposal, but occasionally wait until just before award. Review on activity if subcontractor, expect sub to do the same. Case-by-case can accept another IRB's approval, especially if other institution more experienced. (Allegheny-Singer Research Institute responded but without institution-specific information.)