Summary -- Human Subjects Review Celia Walker 22 Feb 1995 18:38 EST

Response summary re Human Subjects campus practices -- 18
responses.
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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?
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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.)