Human Subjects: New Coverage has been added on 45 CFR 690.118, including new template. New award clause for projects involving human subjects: It is the grantee’s responsibility to ensure that any human subjects work conducted under this award has an Institutional Review Board (IRB) approval, where required, and that such approval remains valid at all times that human subjects work is conducted under this award. Failure to comply with this condition will result in suspension and/ or termination of the award. If the project lacks definite plans regarding use of human subjects, their data or their specimens, pursuant to 45 CFR 690.118, the proposer must check the box for "Human Subjects" on the Cover Sheet and enter “Pending” in the space provided for the approval date. If available at the time of proposal submission, the determination notice should be uploaded as an Other Supplementary Document in FastLane. If the determination notice is not available, and, the decision is made to fund the proposal, the organization must provide a signed copy of the determination notice to the cognizant program prior to award.