March 11, 1999
TO: Chair of Departments which submit protocols
FROM: John Attinasi, Chair of IRB
RE: Institutional Review Board for the Protection of Human Subjects
Last semester the IRB directed me to write you regarding mandatory disclosure and possible subpoena of information gathered as data in research projects. This semester, the IRB asks you to consider an internal matter related to the submission of research protocols.
We frequently find in protocols, that a researcher will propose a type of question, a procedure or other investigative strategy that may be customary and usual in a given field or sub-field, but is unfamiliar to members of the Board. The IRB deliberates at length, and may even delay approval, trying to determine if a research strategy will pose an unusual risk to human subjects. Often we consult with the sponsor or other colleagues to determine if a proposed design is usual or extreme for its discipline. We often find that advance clarification would have avoided significant delays.
To facilitate the resolution of such uncertainties, we have modified the Faculty Supervisor Form, with space for a brief comment recommending the research between the title of the project and signature. We expect the sponsor's statement to anticipate and clarify sensitivities, in order to illuminate areas that may be unfamiliar to the Board.
The sponsor's statement should provide a brief context for the research. If the research is part of a larger study, a typical approach, or has a particular significance, it would speed up the process to have that information on the signature page. If a line of questioning, the use of a substance, or the provision of follow-up counseling is customary, or is specifically incorporated in the research, the faculty sponsor should mention it. It is not necessary to provide a full theoretical rationale for the research. A brief statement [25-50 words] of advocacy is expected along with the adviser's signature on the sponsor's page.
Thank you, in advance, for disseminating this memo to your faculty and keeping copies along with the protocol in your department files.
Modification to the Sponsor form to appear between the Title of Thesis or Project and Signature:
Sponsor's comment regarding the research, data or use of human subjects: