What must be included in an "assurance of compliance" with a U.S. federal agency?

An "assurance of compliance" with a U.S. federal agency is a formal commitment that outlines the ethical and regulatory standards that researchers must adhere to when conducting studies involving human subjects. This assurance is particularly focused on ensuring the protection of participants' rights and welfare as stipulated by the Common Rule, which is a set of federal regulations that govern Human Subjects Research.

Including procedures to ensure the protection of subjects is crucial because it demonstrates compliance with ethical guidelines, emphasizing informed consent, privacy, and risk minimization. This aspect of the assurance reflects the researcher's commitment to uphold the dignity and rights of individuals involved in the research.

While confirmations of funding availability, research timelines and milestones, and details of participant compensation are important elements in the context of a research proposal, they do not specifically pertain to the ethical protections required by federal regulations governing human research. Thus, the correct focus in an assurance of compliance is on the implementation of appropriate procedures to safeguard subjects as outlined in the Common Rule.