Re[2]: College Students as Human Subjects Marsha Green 12 Feb 1998 13:21 EST

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From:     xxxxxx@CCMAIL.lbl.gov AT UNLV
Date:     02/12/98 05:59 PM
To:       "MCW Institutional Review Board Forum" <xxxxxx@post.its.mcw.edu>
 AT UNLV
Cc:
Subject:  Re[2]: College Students as Human Subjects

 Passing on.   mg

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Subject: Re[2]: College Students as Human Subjects
Author:  xxxxxx@CCMAIL.lbl.gov at UNLV
Date:    2/12/98 5:59 PM

 We share an IRB with the University of California at Berkeley.
 Our IRB policy is quite explicit:  if  UCB or LBNL students or
 staff are specifically identified as a recruitment pool, it
 must come through our IRB. (I.e., if the researchers advertise
 on campus or in the Daily Cal, they must have an IRB review; if
 they advertise for young men between 18 and 25 in the San
 Francisco Chronicle they would not ordinarily be subject to
 review.)
 A Student Health Services physician is always a member of the
 IRB, and is usually assigned as primary reviewer in studies
 involving students.
 A few years back a group of students were victims in a
 well-publicized incident.  More than one off-campus researcher
 immediately (and I do mean they flew in within hours) attempted
 to initiate post-traumatic stress studies.  Because the IRB
 found this to be a vulnerable population, did not find an
 acceptable risk:benefit ratio for the students, and questioned
 the method of recruitment, the study(ies) were not approved.
 In specific answer to your questions:
 1) The researcher must have IRB approval.  Approval of the Dean
 of Students may also be required in some cases.  (For example,
 if the IRB had approved the study described above, contacting
 the students would have had to have been arranged through the
 Dean)
 2) The IRB uses the same criteria for reviewing these studies
 as any other.
 3) See above.
 4) Only to the extent that minimal risk/non-minimal risk is
 always handled differently.
 5) Whether your IRB reviews the study or not, my guess would be
 that the institution would be 'liable' in the same way should
 something go wrong.
 6) Parental notification is handled on a protocol by protocol
 basis, just as for any other research.
 As an aside, the IRB is currently considering the implications
 of internet chat room research and our student body. Good luck
 hashing out your own policy.
 Chris Byrne
 IRB/IACUC Coordinator
 Berkeley Lab

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Subject: Re: College Students as Human Subjects
Author:  xxxxxx@post.its.mcw.edu at SMTPLINK-WKSG
Date:    2/12/98 8:10 AM

 Barbara,
 I'm going to forward your email to the MCWIRB Discussion List for
 their input also.  To subscribe to that list send the following
 message in the body (nothing in the subject line):
 subscribe MCWIRB Your Name
 to:  xxxxxx@its.mcw.edu
 It's a great discussion group on any area of protection of human
 subjects and very, very helpful.
 Marsha Green
 UNLV
 xxxxxx@ccmail.nevada.edu
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Subject: College Students as Human Subjects
Author:  Research Administration Discussion Group
<xxxxxx@health.state.ny.us>
at UNLV
Date:    2/12/98 12:02 AM

We periodically have requests from outside researchers to come to our
campus to recruit our students (usually through posters or informational
handouts) as study participants for both behavioral and clinical
studies.  These studies have already been approved by another
IRB--perhaps at a nearby institution, but sometimes by distant,
unfamiliar IRBs.  I would like to hear from other institutions about
procedures you have in place to handle these kinds of requests.
(1) Who gives permission to the outside researcher to recruit on your
campus?
(2) What criteria are used in making the decision to give or deny
permission?
(3) What role, if any, does your own institution's IRB play?
(4) Do you treat invasive and non-invasive studies the same or
differently?
(5) What is the liability of your own institution if you allow an
outsider to recruit on your campus and something goes wrong?
(6) If you allow this practice, do you have an obligation to inform
parents when students apply or are accepted to your institution?
We will be having a discussion about this at our February 19 IRB
meeting, so quick responses will be appreciated.  I expect that this
question will generate a fair amount of interest, so please share your
comments with the entire list.
Thanks!
Barbara
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Barbara H. Gray                                    Telephone:
803-953-5673
Director of Sponsored Programs       Fax: 803-953-6577
College of Charleston                          email:  xxxxxx@cofc.edu
Charleston, SC  29424                           http://www.cofc.edu/~osp
(Location:  407G Bell Building)
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