The document serves as a draft notice of “Preliminary Approval” from an Institutional Review Board (IRB) for National Science Foundation (NSF) projects that are in the early stages of development and do not yet involve human subjects, their data, or biological specimens. It outlines that the IRB has conducted an expedited review and granted preliminary approval under federal regulation 45 CFR 46.118, which applies to projects for which the protocols involving human subjects have not been fully developed. The notice specifies the relevant dates for the initial approval, the current approval period, and the expiration date, and references the appropriate OHRP IRB registration numbers.
Importantly, the preliminary approval acknowledges the proposed scope of the study but explicitly prohibits any initiation of work with human subjects, including recruitment, until further review and full IRB approval are secured. Investigators are required to submit either an amendment or a new IRB application before the expiration date to obtain the necessary approval for engaging human subjects in research activities. This notice ensures regulatory compliance and ethical oversight for projects pending further development of human subjects research protocols.
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.
