Exemptions for Research Involving Human Subjects. Exemption determinations for human subject research to be conducted under this Award should only be made by authorized representatives of (1) an OHRP-registered IRB, or equivalent, or (2) the CAPO. Exemption determinations made by an OHRP- registered IRB, or equivalent, should be submitted to the CAPO for review and record-keeping. Program Officers, principal investigators, research staff, and other DHS or institutional personnel should not independently make exemption determinations in the absence of an IRB or CAPO review. DHS Program Officers (or institutions conducting human subjects’ research under this Award) seeking an exemption determination from the CAPO should submit a request to XXxxxxxxxxxxxxxxxxxxxx@xx.xxx.xxx that includes the following:
a. Research protocol or detailed description of planned activities to be conducted under this Award.
b. Identification of the exemption category that applies to the project(s) to be conducted under this Award and explanation of why the proposed research meets the requirements for that category of exemption. All documentation, as well as any questions or concerns regarding the requirements referenced above, should be submitted to the CAPO at XXxxxxxxxxxxxxxxxxxxxx@xx.xxx.xxx. The submitted documentation will be retained by the CAPO and used to conduct a regulatory compliance assessment. Additional documentation may be required in some cases to complete this assessment. The Recipient must provide this documentation upon request, and address in writing any compliance issues or concerns raised by the CAPO before a certification letter is issued and participant enrollment can begin under this Award. The CAPO will review all submitted materials and provide written confirmation to the Recipient once all documentation requirements have been met. The Recipient and any Recipient institution shall submit updated documentation regarding ongoing research involving human subjects, as available and prior to the expiration of previous approvals. Such documentation includes protocol modifications, IRB renewals for ongoing research protocols (“Continuing Reviews”), and notifications of study completion. The Recipient must promptly report the following to the CAPO, along with any corrective actions taken: (1) any serious or continuing noncompliance with human subjects research regulations and policies adopted by DHS (as referenced above); and (2) suspension, termination, or revocation of IRB approval of any human subjects resear...
Exemptions for Research Involving Human Subjects. Exemption determinations for human subject research to be conducted under this Award should only be made by authorized representatives of (1) an OHRP-registered IRB, or equivalent, or (2) the RCO. Exemption determinations made by an OHRP- registered IRB, or equivalent, should be submitted to the RCO for review and record-keeping. Program managers, principal investigators, research staff, and other DHS or institutional personnel should not independently make exemption determinations in the absence of an IRB or RCO review. DHS program managers (or institutions conducting human subjects’ research under this Award) seeking an exemption determination from the RCO should submit a request to XXxxxxxxxxxxxxxxxxxxxx@xx.xxx.xxx that includes the following: a. Research protocol or detailed description of planned activities to be conducted under this Award.
