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Dear Colleagues:
The Nonmedical IRB is embarking on a new pilot project to streamline the review process and lessen administrative burden on researchers, while still affording protections to human subjects. Effective October 1, 2011, the Nonmedical IRB will discontinue annual review of minimal risk non-federally supported human subject research until the third year of ongoing research.
Rather than requiring the submission of an annual review, reminders will be sent annually to researchers to assess if they qualify for triennial review. Researchers must be able to answer “NO” to the questions below to continue qualifying for triennial review.
Has your study experienced any of the following:
- substantive changes (e.g., study design, consent form)?
- increase in risks?
- unanticipated problems? or
- federal funding added to the protocol?
If the answers to the above questions are all “NO”, researchers will have no requirement to follow up with the IRB or file an application. At the end of year three if the study remains open, a Continuing Review application will be required at that time.
We welcome hearing from you with continued comments and recommendations to enhance protections for research subjects while reducing burden for investigators.
Sincerely,
Ann M. Arvin, M.D.
Vice Provost and Dean of Research
Penelope Eckert, Ph.D.
Chair, Nonmedical IRB 2