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

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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/
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