COGR has recently engaged in conversations with Jean Feldman, Head, Policy Office, and Jeff Mantz, Human Subjects Research Protection Officer, National Science Foundation, regarding applications and proposals lacking definite plans for involvement of human subjects. Per 45 CFR 690.118, applications lacking definite plans, such as “projects in which human subjects’ involvement will depend upon completion of instruments, prior animal studies, or purification of compounds,” need not be reviewed by an IRB before an award is made. NSF has indicated that for studies that meet these criteria, IRBs may use a “Preliminary Approval” notice for NSF projects (see "Read More" below) and that this approval is consistent with the Proposal and Award Policies and Procedures Guide.
The letter was drafted by Cindy Shindledecker and Lois Brako of the University of Michigan who have been working with Jeff and others on this for some time and we appreciate all of the work that they have done. The draft letter provides a limited approval period and indicates that the investigator must submit an amendment or new IRB application for full IRB approval of the project prior to the expiration date. It also emphasizes that no work with human subjects, including recruitment, may be conducted under the determination. Establishing a time limit, whether it is 3 or 6 months, requires investigators to return to the IRB and establishes accountability. Please contact Lisa Nichols if you have questions or concerns about the use of this draft letter.
