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March 1, 2013
Dear Colleagues:
The Research Compliance Office is implementing a new procedure to streamline the review process and reduce administrative burden on researchers, while still affording protections to human subjects. Effective March 1, 2013, the IRBs will discontinue annual renewal of chart review protocols that involve minimal risk non-federally sponsored human subject research until the end of year three of ongoing research.
Rather than an annual renewal, chart review studies that qualify will be reviewed once every three years, as long as there are no:
- increase in risks
- unanticipated problems, or
- federal sponsor(s) added to the protocol.
Notices will be sent annually to researchers. No renewal application will be required until the end of year three, provided the study remains open and continues to qualify for triennial review. All VA studies are excluded from the Extended Approval Policy.
The Extended Approval Policy for medical chart review studies is part of our HRPP manual.
We appreciate hearing your comments and recommendations to enhance protections for research subjects while reducing burden for investigators. You can send further comments or recommendations to the IRB at streamline@stanford.edu .
Sincerely,
Ann M. Arvin, M.D.
Vice Provost and Dean of Research
David D. Oakes, M.D.
IRB Chair, Professor of Surgery, Emeritus