Updates to NIH Grants Policy re: Human Subjects (Oct 2021)
Below is information extracted from the Grants Policy that's specific to human subjects use in grant proposals. For more information, click on: https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4.1.15_human_subjects_protections.htm
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4.1.15 Human Subjects Protections
Following proposal submission, the NIH will review the materials submitted, including the Protection of Human Subjects attachment of PHS CT Form, to determine if the NIH can concur with the statement of exempt category research
Upon accepting an award that supports human subjects research, institutions assume responsibility for all research conducted under the award, including those from consortium sites. Recipient institutions assume responsibility that all institutions under the award engaged in non-exempt human subjects research have a current, approved FWA and must obtain certification from engaged institutions of approval by an IRB registered with OHRP.
Applications will be considered incomplete if they do not address the involvement of human subjects in the protection of human subjects in attachment of PHS HS CT Form. If human subjects research is anticipated within the period of the award but definite plans for involvement of human subjects cannot be described in the application, applicants must provide a detailed explanation of why it is not possible to develop definite plans and why such research is delayed.
The ORPC has a webpage page to request planning phase approval for NIH submissions if plans have yet been developed. Click on this link for more information.
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4.1.15.10 NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
NIH requires sites engaged in NIH-funded, multi-site research conducted at more than one domestic site to rely upon approval by a single Institutional Review Board (sIRB). NIH applicants whose research is subject to the sIRB requirements must provide the name of the sIRB during the Just-in-Time period, before the award is issued. If, in delayed-onset research, an sIRB has not yet been identified, the recipient will provide the name of the sIRB to the funding NIH Institute/Center (IC) prior to initiating the multi-site research study/project.
Recipients are responsible for ensuring that authorization agreements are in place. Copies of authorization agreements and other necessary documentation should be maintained to document compliance, as needed. As appropriate, recipients are responsible for ensuring that a mechanism for communication between the sIRB and participating sites is established.
The ORPC can assist investigators with creating reliance agreements. Click on this link for more information.
If you have any questions, please contact us at compliance@umbc.edu.
Posted: January 18, 2022, 12:18 PM