The document serves as an official notification regarding a project evaluated under 45 CFR 46.118, which pertains to research activities that currently lack immediate plans for the involvement of human subjects, their data, or their specimens. Although the referenced project is expected to include future human subjects research, its protocol is not yet fully developed. As a result, Institutional Review Board (IRB) approval is not required at present. However, within one year of the determination date, the Authorized Organizational Representative must either confirm that the project still does not involve human subjects or provide documentation demonstrating IRB approval to the relevant NSF Program Officer. No research activities involving human subjects, including recruitment, may proceed under this grant or protocol until IRB approval has been obtained. The document provides a point of contact for any related inquiries.
COGR has been working with NSF staff to develop
lacking definite plans for involvement of human subjects. The letter indicates that the grant or protocol meets the requirements of 45 CFR 46.118 and stipulates that “one year from the date identified above, the Authorized Organizational Representative is required to either verify that the project continues to lack immediate plans for the involvement of human subjects, their data, or their specimens; or provide documentation to the cognizant NSF Program Officer to demonstrate that IRB approval has been obtained.” Universities that utilize this notification letter will therefore track the expiration through their financial or IRB systems (or other mechanisms). These changes will be reflected in the next version of the NSF Proposal and Award Policies and Procedures Guide that is scheduled for release in October 2016 and a link provided to the letter which will be available on the NSF website.
