The Research Compliance Assurance (RCA) section of the Duke University Compliance Program focuses on transactional outcomes testing across all aspects of human subject research. RCA reviews assess transaction-level performance against applicable federal rules and regulations and Duke policies. Reviews focus on promoting and maintaining research excellence, responsibility and integrity as well as sponsored programs administration, oversight and reporting.
In addition to performing for-cause reviews at the direction of Duke senior leadership, RCA serves as an institutional liaison with external regulatory agencies when visiting the university to perform for-cause inspections.
RCA performs human subject research compliance reviews as a component of the Human Research Protection Program (HRPP) and submits these review summaries to the Institutional Review Board (IRB) and other institutional officials. These compliance reviews serve as a confidential quality assurance measure internal to the institution.
- Process Flow
- Summary of Audit Process for RCA human subject reviews
- What to do if you receive a notice of an FDA audit
- Principal Investigators Questionnaire: As part of the notice of intent to review, study teams are asked to complete the following questionnaire and return it to OARC-RCA@duke.edu (link sends e-mail) or fax to 919.613.7631. We like to get information directly from the study team about their level of training and experience, as well as some specific information about the protocol being reviewed.
- Faculty Arrival and Departure Flowchart and HR Termination Transfer Checklist
Campus Institutional Review Board
The Campus Human Subjects Protections Program works with investigators to protect the rights and welfare of research participants. Program staff pre-review submissions to the IRB for non-medical research, providing feedback, consultation and interpretation of applicable regulations.
Duke Policy of the Academic Council - This policy includes a statement of principles and a procedural section. It provides specific protections for Duke students and employees to avoid the potential for coercion, however unintended, of those subjects.
Human Subject Research Operational Oversight
Clinical Research Units
Clinical Research Units (CRUs) are the operating business unit responsible for oversight including integrity, financial accountability, regulatory compliance, quality and academic productivity of clinical research studies.
Campus Oversight Organization
This is the operational home for campus investigators who need to utilize the DUHS IRB for protocol approval. This group has developed an oversight plan which delineates responsibilities to be performed by the Campus Oversight Organization as well as campus investigators. See the Campus Oversight Plan for DUHS IRB-approved protocols from campus-based researchers.
Human Subject Research Policies - Duke Office of Clinical Research
The Duke Office of Clinical Research (DOCR) supports the CRUs (including all faculty, staff and students) by developing the "navigation, tools, and training" for the conduct of clinical research in which Duke serves as an investigative site. DOCR has developed institutional policies for:
- Study start-up
- Ongoing study management
- Study close-out
- DOCR policy definitions (internal, requires employee login to open this PDF)
Note: The policies and definitions at the links above are behind the Duke firewall and require a NetID and password to access.
Duke Health Institutional Review Board
The Duke Health IRB (Duke IRB) has responsibility for review of research involving human subjects for the Duke University Schools of Medicine and Nursing, Duke Regional Hospital (formerly Durham Regional Hospital), Duke Raleigh Hospital and Duke Primary Care.
The Duke IRB's mission is to ensure the protection of human research subjects by conducting scientific and ethical review of research studies while providing leadership and education for the research community. See Human Research Protection Program Policies (link).
The Office of Regulatory Affairs and Quality (ORAQ) serves as a no-cost resource to the clinical research community at Duke. ORAQ offers regulatory and quality assurance support in all aspects of clinical research from preclinical requirements to first-in-human studies and beyond. This office oversees a variety of services including regulatory education, regulatory consultation, and support for regulatory submissions and Good Manufacturing Practice (GMP) manufacturing.