Compliance and Regulatory Affairs
The Compliance and Regulatory Affairs domain tests the regulatory perimeter around sponsored projects: human subjects, animal welfare, conflict of interest, export controls, responsible conduct of research, data security, biosafety, and audit or monitoring. Exam questions often ask which approval is needed, when it is needed, and what to do when a requirement changes.
Core rules and concepts
- Human subjects research is governed by 45 CFR 46 and institutional IRB policies. Obtain IRB approval before recruitment or enrollment, use approved consent, report unanticipated problems, and follow continuing-review requirements. HIPAA applies when protected health information is involved.
- Animal research requires IACUC approval under the PHS Policy and, for USDA-covered species, 9 CFR requirements.
- Conflict of interest: PHS-funded investigators disclose significant financial interests under 42 CFR 50 Subpart F; institutions manage, reduce, or eliminate conflicts. 2 CFR 200.112 also requires written COI policies.
- Export controls: ITAR and EAR can apply to technology, technical data, and deemed exports. Screen restricted parties and use a technology control plan when needed.
- Responsible conduct of research covers data management, authorship, plagiarism, animal and human subjects, and misconduct. Training may be required by NIH, NSF, or the institution.
- Protect data according to sponsor and institutional requirements, especially human-subjects data, controlled unclassified information, and data-sharing plans.
- Retain records for three years after the final financial report under 2 CFR 200.334 and support subrecipient monitoring and Single Audit.
Worked example
A PI wants to send human biospecimens to a foreign collaborator without an IRB amendment or material transfer agreement. Reasoning: biospecimens may be human-subjects data, and the consent and IRB approval must cover sharing. A material transfer agreement protects the institution and defines use. Export-control and country-specific restrictions may also apply, and the sponsor may require notification. The correct action is to stop the shipment, review the consent and IRB approval, execute the agreement, and obtain any required approvals before transfer.
Traps that cost marks
- Treating IRB approval as a one-time event and ignoring amendments or continuing review.
- Missing export-control issues in foreign collaborations or subawards.
- Assuming a conflict-of-interest disclosure is optional or can wait until after the award.