Re: What would your IRB do? Vincelli, Diana 13 Jun 2003 07:51 EST
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") ======================================================================