June 03, 2013

Human Research Protection: Three-Year Approval for Qualifying Minimal Risk Research

The Committee for Protection of Human Subjects (CPHS), in collaboration with the Office for the Protection of Human Subjects (OPHS) and the Vice Chancellor for Research, has announced the following change in policy. UC Berkeley will join UC Davis and UC San Francisco in utilizing flexibility available under our Federalwide Assurance (FWA) regarding certain study approval periods. Specifically, effective June 1, 2013, CPHS will begin issuing three (3) year approvals for research that qualifies for this extended approval period. To qualify, the research must:
  1. involve no more than minimal risk to participants (as defined by 45 CFR 46.102);
  2. not be supported by federal funds; and
  3. not be subject to federal oversight.
For more detailed information, e.g., about what to do if federal funding is received after initial approval, how to apply for Continuing Review of currently approved research, or what kind of studies are not eligible for this extended approval period, see Three-Year Approval FAQs.

The CPHS/OPHS decided to make this change after an in-depth analysis of the type of research conducted at UCB and what, if any, funding supports that research. We found that for many years, a large majority of the research conducted by UCB investigators has been determined to be no greater than minimal risk to the subjects (participants) of that research. Likewise, approximately two-thirds of the human research protocols reviewed by CPHS are not federally funded or subject to federal oversight (e.g., FDA). Therefore, CPHS/ OPHS felt that we could and should assist our investigators by using the flexibility in the terms of our FWA to grant three-year instead of one-year approval periods where appropriate. Of course, this will not change the ethical standards by which a protocol is evaluated. We hope that investigators will appreciate this reduction of their administrative burden, while we continue to work together to ensure the welfare of the people who participate as subjects in research.