Barbara,

You should have a look at our institutions policies and regulations
applicable to students and graduation.

I would suggest that the IRB should not try to impose sanctions on its own,
but refer the matter to the proper academic authorities, with explication as
to the gravity of the "offense", damage caused, etc...

You could use this incident as a learning opportunity since its seems that
many people in the institution may have failed to act in a timely fashion,
and allowed this situation to arise. The system for the protection of human
subjects need to involve many actors, not only the IRB and the investigators
!!

Regards,

Luc Simon

Le 12/06/03 14:13, « Barbara Gray » <xxxxxx@COFC.EDU> a écrit :

> 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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=========
Luc Simon

Conseiller en gestion de la recherche
Vice-rectorat a la recherche
Université Laval
Telephone: (418) 656-2131 - poste 5301
Telecopieur: (418) 656-2506
Email: xxxxxx@vrr.ulaval.ca

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