What must a compliance assurance agreement describe?

A compliance assurance agreement is essential in research involving human subjects, as it lays out the procedures that will be followed to ensure the protection of these subjects according to the Common Rule. This is crucial because the Common Rule establishes the ethical standards and guidelines for conducting research involving human participants, ensuring their rights and welfare are safeguarded.

The agreement needs to encompass how the research will adhere to regulations regarding informed consent, risk assessment, and the safeguarding of participant data. By clearly identifying these procedures, the agreement serves as a commitment to ethical research practices, which is a fundamental aspect of compliance in research funded or conducted in settings governed by institutions that adhere to the Common Rule.

While the other options may be relevant to aspects of research, they do not specifically capture the essence of what a compliance assurance agreement must outline in terms of subject protection protocols as mandated by ethical regulations.