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 fundamentally revolves around the ethical treatment and protection of human subjects involved in research. As such, it must include procedures that ensure subject protection in accordance with the Common Rule, which is a set of federal regulations aimed at safeguarding the rights and welfare of human subjects in research studies.

These procedures typically encompass informed consent processes, confidentiality measures, risk assessment, and protocols for minimizing potential harm to participants. This compliance is crucial in establishing trust and ensuring that research adheres to ethical standards set by regulatory bodies. Focus on these procedures reflects an institution's commitment to conducting ethical research that prioritizes the safety and rights of individuals participating in studies.

While aspects like funding distribution, expected research outcomes, and data analysis methods are important components of a research proposal or study design, they do not specifically pertain to the assurance of compliance concerning the ethical guidelines for human subjects defined by federal regulations.