TERMS OF THE FEDERALWIDE ASSURANCE FOR THE PROTECTION OF HUMAN SUBJECTS

U. S. Department of Health and Human Services Office for Human Research Protections

This document delineates the terms of the U.S. Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP) Federalwide Assurance (FWA) for the protection of human subjects.

1. Applicability

These terms apply whenever the institution 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.

For information on the meaning of “engaged,” see OHRP’s guidance: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html

For the purposes of the FWA, federally supported research generally refers to research for which the U.S. Government is providing funding or other material support. For assistance in determining whether a particular research project is "supported," please consult with the federal department or agency involved in the research.

For a list of U.S. federal departments and agencies that have adopted or otherwise follow the Common Rule, see Appendix.

2. Compliance with Laws, Regulations, and Guidelines

(a) U.S. Institutions:

When a U.S. institution becomes engaged in research to which the FWA applies, the institution and the institutional review boards (IRBs) upon which it relies for review of such research will comply with the Federal Policy for the Protection of Human Subjects, also known as the Common Rule. The reference in the U.S. Code of Federal Regulations (CFR) is shown in the Appendix for each U.S. federal department and agency which has adopted the Common Rule.

(b) Non-U.S. Institutions:

When a non-U.S. institution becomes engaged in research to which the FWA applies, the institution and the IRBs upon which it relies for review of such research will comply with the Common Rule. The reference in the U.S. CFR is shown in the Appendix for each U.S. federal department and agency which has adopted the Common Rule. If a U.S. federal department or agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided by the Common Rule, the department or agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in the Common Rule, consistent with the requirements of 45 CFR 46.101(h).

(c) U.S. and non-U.S. Institutions:

For any research to which the FWA applies, the institution also will comply with any additional applicable human subjects regulations of the U.S. federal department or agency that conducts or supports the research.

When an institution is engaged in nonexempt human subjects research conducted or supported by HHS, the institution will comply with the requirements of these subparts of 45 CFR part 46:

• Subpart A – Basic HHS Policy for Protection of Human Research Subjects
• Subpart B – Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
• Subpart C – Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
• Subpart D – Additional Protections for Children Involved as Subjects in Research
• Subpart E – Registration of Institutional Review Boards

IRBs upon which the institution relies for review of research conducted or supported by HHS to which the FWA applies must be registered with OHRP.

Human subjects research conducted or supported by each U.S. federal department or agency listed (see Appendix) will be governed by the regulations as implemented by the respective department or agency. The head of the U.S. federal department or agency retains final judgment as to whether a particular activity conducted or supported by the respective department or agency is covered by the Common Rule. If an institution needs guidance regarding implementation of the Common Rule or other applicable U.S. federal regulations, the institution should contact appropriate officials at the U.S. federal department or agency conducting or supporting the research.

For U.S. federally conducted or supported research covered by the FWA, the U.S. federal department or agency that conducts or supports the research retains final authority for determining whether the institution complies with the Terms of Assurance. If HHS receives an allegation or indication of noncompliance related to research to which the FWA applies and that is conducted or supported solely by a U.S. federal department or agency other than HHS, HHS will refer the matter to the other U.S. federal department or agency for review and action as appropriate.

3. Reliance on IRBs Unaffiliated with an Institution Holding an FWA

Whenever an institution relies upon an IRB operated by another institution or organization for review of research to which the FWA applies, the institution and the organization operating the IRB must document the reliance and the responsibilities that each entity will undertake to ensure compliance with the requirements of the Common Rule. This documentation can occur, for example, through a written agreement between the relying institution and the reviewing IRB, by implementation of an institution-wide policy that identifies the reliance and the respective responsibilities of each party, or through a description of the reliance and respective responsibilities of the relying institution and reviewing IRB that is included in a research protocol. This documentation must be kept on file at both institutions or organizations and must be made available upon request to OHRP or any U.S. federal department or agency conducting or supporting research to which the FWA applies.

4. Renewal or Update of the Assurance

In order to maintain a satisfactory written assurance, OHRP requires that an institution renew its FWA every 5 years, even if no changes have occurred.

OHRP also requires that an institution update its FWA within 90 days after changes occur regarding the legal name of the Institution, the Human Protections Administrator, or the Signatory Official.

Any renewal or update that is submitted to, and accepted by, OHRP begins a new 5-year effective period.

Failure to renew or update an FWA while continuing to engage in research subject to the Common Rule may constitute noncompliance.

Appendix: Common Rule Federal Departments or Agencies