Where should institutions seek guidance on compliance with the Common Rule?

Institutions should seek guidance on compliance with the Common Rule from the department or agency conducting or supporting the research because it is the primary source of information regarding the regulations that govern human subjects research federally. These departments and agencies, such as the Department of Health and Human Services (HHS) or the National Institutes of Health (NIH), provide clarity on the specific requirements, protocols, and interpretations of the Common Rule that apply to the research being conducted. They offer resources, guidance, and oversight mechanisms to ensure that research adheres to ethical standards and regulatory compliance.

Additionally, these departments are responsible for monitoring compliance and can provide support to institutions in navigating the complexities of federal regulations and the specific nuances of the Common Rule. By consulting with the relevant department or agency, institutions can ensure they are aligned with the latest policies and practices, thereby enhancing the ethical conduct of their research involving human subjects.