Requirements for Research Involving Human Subjects. Each facility conducting work involving human subjects under this Award is required to have a project-specific Certification of Compliance letter issued by the RCO. Each Recipient must submit the following documentation to the RCO for compliance review and certification prior to initiating research involving human subjects under this Award:
a. Research protocol, as approved by an Institutional Review Board (IRB), for any human subjects research work to be conducted under this Award;
b. IRB approval letter or notification of exemption (see additional information below on exemption determinations), for any human subjects research work to be conducted under this Award;
c. IRB-approved informed consent document(s) (templates) or IRB waiver of informed consent for projects involving human subjects research under this Award; and
d. Federal-wide Assurance (FWA) number from the HHS Office for Human Research Protections (OHRP), or documentation of other relevant assurance, for all Recipient institutions (including Sub- recipients) involved in human subjects research under this Award.
Requirements for Research Involving Human Subjects. Each Center conducting research involving human subjects under this Award is required to have a project- specific Certification Letter, a determination memo, or a memo of concurrence with an IRB’s research or exemption determination issued by the CAPO. Each Recipient must submit the following documentation to the CAPO for compliance review and clearance prior to initiating research involving human subjects under this Award:
a. Research protocol, as approved by an Institutional Review Board (IRB), for any human subjects research work to be conducted under this Award;
b. IRB approval letter or notification of exemption (see additional information below on exemption determinations), for any human subjects research work to be conducted under this Award.
c. IRB-approved informed consent document(s) or IRB acknowledgement of a waiver or alteration of informed consent for projects involving human subjects research under this Award;
d. Any applicable IRB-approved surveys/questionnaires and recruitment materials;
e. Federal-wide Assurance (FWA) number from the Dept of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) for all Recipient institutions (including Sub-recipients) engaged in human subjects research under this Award;
f. IRB registry number for the IRB of Record (IRB0000XXXX) and the IRB Panel Number (if reviewed by the full board);
g. The DHS-approved Statement of Work (SOW) or workplan; and
h. DHS CAPO’s Cover Sheet and Document Checklist.
i. Research protocol or detailed description of planned activities to be conducted under this Award;
j. A complete CAPO Human Subjects Research Determination Request Form (HDRF);
k. The DHS-approved Statement of Work (SOW) or workplan;
l. Any applicable informed consent document(s);
m. Any applicable surveys/questionnaires and recruitment materials; and
n. 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 through the DHS Program Manager to the CAPO The submitted documentation will be retained by the CAPO and used to conduct a regulatory compliance assessment. Additional documentation and/or information may be required in some cases to complete this assessment. The Recipient must provide this documentation and information u...
