Notification of 45 CFR 46 118_Final

The document informs the principal investigator that their grant or protocol has been reviewed and determined to meet the requirements of 45 CFR 46.118. This regulation pertains to projects that currently lack immediate plans for the involvement of human subjects, their data, or their specimens, often because the research protocol is not yet fully developed. The notification outlines the responsibility of the Authorized Organizational Representative to, within one year, either confirm the project continues not to involve human subjects or submit proof of Institutional Review Board (IRB) approval if such involvement is planned. It clearly emphasizes that no research activities with human subjects, including recruitment, are permitted under this protocol or grant until IRB approval is formally secured. For any further information or clarification, the document directs inquiries to a specified contact individual.