MSU HRPP Manual Section 1-1

Federal Wide Assurance

Revised Common Rule Requirements

“(a) Each institution engaged in research that is covered by this policy, with the exception of research eligible for exemption under §46.104, and that is conducted or supported by a Federal department or agency, shall provide written assurance satisfactory to the department or agency head that it will comply with the requirements of this policy. In lieu of requiring submission of an assurance, individual department or agency heads shall accept the existence of a current assurance, appropriate for the research in question, on file with the Office for Human Research Protections, HHS, or any successor office, and approved for Federal-wide use by that office. When the existence of an HHS-approved assurance is accepted in lieu of requiring submission of an assurance, reports (except certification) required by this policy to be made to department and agency heads shall also be made to the Office for Human Research Protections, HHS, or any successor office. Federal departments and agencies will conduct or support research covered by this policy only if the institution has provided an assurance that it will comply with the requirements of this policy, as provided in this section, and only if the institution has certified to the department or agency head that the research has been reviewed and approved by an IRB (if such certification is required by §46.103(d)).

(b) The assurance shall be executed by an individual authorized to act for the institution and to assume on behalf of the institution the obligations imposed by this policy and shall be filed in such form and manner as the department or agency head prescribes.” 45 CFR 46.103(2018 Requirements)

Pre-2018 Common Rule Requirements

“(a) Each institution engaged in research which is covered by this policy and which is conducted or supported by a federal department or agency shall provide written assurance satisfactory to the department or agency head that it will comply with the requirements set forth in this policy. In lieu of requiring submission of an assurance, individual department or agency heads shall accept the existence of a current assurance, appropriate for the research in question, on file with the Office for Human Research Protections, HHS, or any successor office, and approved for federalwide use by that office. When the existence of an HHS-approved assurance is accepted in lieu of requiring submission of an assurance, reports (except certification) required by this policy to be made to department and agency heads shall also be made to the Office for Human Research Protections, HHS, or any successor office.

(b) Departments and agencies will conduct or support research covered by this policy only if the institution has an assurance approved as provided in this section, and only if the institution has certified to the department or agency head that the research has been reviewed and approved by an IRB provided for in the assurance, and will be subject to continuing review by the IRB. Assurances applicable to federally supported or conducted research shall at a minimum include . . .” 45 CFR 46.103(Pre-2018 Requirements)

Michigan State University (MSU) has an approved Federalwide Assurance (FWA) with the Office for Human Research Protections (OHRP). Through the FWA, MSU assures it will comply with the terms of the FWA whenever MSU becomes engaged in human subjects research conducted or supported by any U.S. federal department or agency that has adopted the Common Rule, unless the research is otherwise exempt from the requirements of the Common Rule or a U.S. federal department or agency conducting or supporting the research determines that the research shall be conducted under a separate assurance. MSU also maintains active Institutional Review Board (IRB) registration with OHRP as required by the Common Rule in compliance with 45 CFR 46 Subpart E and the U.S. Food and Drug Administration (FDA) in compliance with 21 CFR 56.106.

MSU has two IRBs that have oversight for research conducted under its FWA #00004556:

  1. Michigan State University IRB #1 – Biomed & Health IRB – BIRB – IRB registration #00000297
  2. Michigan State University IRB #3 – Social Science / Behavioral / Educational IRB – SIRB – IRB registration #00005250

These IRBs provide oversight for research conducted under the assurance and for research that is subject to MSU HRPP oversight as defined in HRPP Manual 4-1 “Applicability.” With limited exceptions for research that is subject to a fully executed reliance agreement, no human subject research may be initiated by MSU employees, staff, students, or any other individuals to whom the MSU HRPP policies and procedures apply to prior to approval by one of the designated IRBs or an exempt determination. See HRPP Manual 4-1 “Applicability.”

The FWA Terms of Assurance establish additional requirements and responsibilities that apply to MSU and the designated IRBs. These requirements are incorporated in other policies and procedures in the HRPP Manual.

For descriptions of the types of human research each MSU IRB reviews, see HRPP Manual 4-1 “Applicability.”

Approved By

Vice President of Research and Graduate Studies, 3-3-05. Revision 1 approved by VP Research & Graduate Studies on 3-9-2008. Revision 2 approved by the VP Research & Graduate Studies on 7-21-2011. Revision 3 approved by Assistant VP Regulatory Affairs on 11-24-2015. Revision 4 approved by Senior VP for Research and Innovation on 1-18-2019.

This policy and procedure supersedes those previously drafted.

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