An agreement called an Assurance of Compliance with a U.S. federal agency must describe procedures to guarantee compliance with federal regulations, especially regarding the protection of human subjects in research. Key procedures that must be described include:

• Procedures for ensuring adherence to ethical principles, such as compliance with guidelines like the Declaration of Helsinki.
• Procedures for subject randomization in research studies.
• Procedures for protecting subjects, including the involvement of an independent committee or Institutional Review Board (IRB) to review research protocols.
• Procedures for prompt reporting of unanticipated problems involving risks to subjects or others.
• Procedures for reporting serious or continuing noncompliance with federal regulations or IRB requirements.
• Procedures for reporting suspension or termination of IRB approval.
• Overall compliance with laws, regulations, policies, and guidelines governing federally supported research.

Additionally, the institution must have established written procedures for timely notification to the IRB, institutional officials, federal agency heads, and regulatory bodies about any unanticipated problems, noncompliance issues, or IRB approval changes. The institution also pledges to provide copies of these procedures to the Office for Human Research Protections (OHRP) and relevant federal agencies upon request. These assurances provide a formal commitment that the institution will follow ethical and regulatory standards established for federally conducted or supported research activities, particularly involving human subjects.