Here's what our IRB chair, Assoc Dean Dona Hickey says:
"If the protocol is already exempt from further IRB review because it is
low-risk, non-sensitive, etc., and because the student does not intend to
report results beyond the classroom, I don't see what the "punishment" would
be or how it is a serious enough offense to warrant the penalties list at
end of the message. In other words, the research conducted by the student
was confined to the classroom (not subject to federal guidelines) and no
participants were un-protected or at risk through the student's study.
The first responsible party would be the faculty supervisor of student
research. I would recommend a written reprimand copied to the chair of the
department. Another failure to instruct students about IRB guidelines and
process could mean suspension of research advising for a period of time.
There is no excuse for that kind of omission in training students to do
responsible, credible, sound research."
Diana Thompson Vincelli
Associate Director
Foundation, Corporate & Government Relations
G-14 Maryland Hall
University of Richmond, VA 23173
804.289.8005; fax 804.287.6491
xxxxxx@richmond.edu
oncampus.richmond.edu/academics/grants
-----Original Message-----
From: Barbara Gray [mailto:xxxxxx@COFC.EDU]
Sent: Thursday, June 12, 2003 2:14 PM
To: xxxxxx@HRINET.ORG
Subject: [RESADM-L] What would your IRB do?
How do you think your IRB would handle the following situation:
A student submits a Bachelor-s thesis protocol application to interview
church women about their thoughts and feelings about being women and
mothers as church members. (We required students doing Bachelor's
thesis and independent study research to adhere to IRB guidelines.) She
will tape the interviews, but no sensitive information is being sought.
She will verbally explain the study; participation in the interview is
assumed to be consent. Thus far, our determination is that the research
is exemptable. However, the student indicates that she may use the
tapes later for other researchpurposes. We advised her that, to do so,
she would have to get written consent from the participants and we would
do an expedited review instead. She opted not to use the tapes for
anything further. However, when she made this decision, she included
language that indicated the study had already been completed. When we
checked, we found that this was indeed the case--she was getting married
toward the end of the semester, completed theBachelor's thesis for which
the research was conducted, graduated in mid-May (with honors), and has
moved to Utah. So we have the case of research, albeit exemptable,
which occurred without IRB exemption or approval.
Both the student and the faculty advisor had access to all policies and
procedures on our website. Both completed the NIH tutorial which
clearly explains the role of the IRB. Our IRB does not do "after the
fact" approvals or exemptions. My guess is that neither the student nor
the faculty advisor realize the seriousness of the situation at this
point.
What would be the likely sanctions your IRB would enact for the student
(nothing, taking away credit for the course and negating graduation,
stripping "honors" designation, sending the matter to the student honor
board, etc.) and for the faculty member (nothing, oral reprimand,
written reprimand, copies of reprimand in permanent file, not allowing
student research advising for a period of time, etc.) On one hand, the
IRB and its policies need to be taken seriously, but, on the other hand,
we want to make sure that punishment fits the crime. Based on past
experience, our IRB is likely to be divided on the seriousness of the
sanctions required, so any input will be helpful.
Thanks.
Barbara
--
==================================================================
Barbara H. Gray, Director
Office of Research & Grants Administration
College of Charleston
66 George Street
Charleston, SC 29424
Campus Location: 407-G Bell Bldg.
Office: 843.953.5673 Desk: 843.953.5885 Fax: 843.953.6577
e-mail: xxxxxx@cofc.edu URL: http://www.orga.cofc.edu/
==================================================================
======================================================================
Instructions on how to use the RESADM-L Mailing List, including
subscription information and a web-searchable archive, are available
via our web site at http://www.hrinet.org (click on "Listserv Lists")
======================================================================
======================================================================
Instructions on how to use the RESADM-L Mailing List, including
subscription information and a web-searchable archive, are available
via our web site at http://www.hrinet.org (click on "Listserv Lists")
======================================================================
