Human Subject Research Compliance
The Human Subject Research Compliance (HSRC) section of the Duke University Compliance Program is responsible for conducting routine and directed reviews of Institutional Review Board (IRB) approved human subject research protocols to:
- assess adherence to the IRB approved study protocol, good clinical practices (GCP) guidelines, and state and federal regulations;
- determine that the rights and welfare of human research subjects are being or have been adequately protected by the investigator and his/her research staff; and
- assess the integrity of the study data.
The HSRC section serves as an institutional liaison with the Food and Drug Administration and other regulatory agencies visiting the university for inspections.
- Process Flow
- Summary of Review Process for HSRC Human Subject Reviews
- What to do if you receive a notice of an FDA audit?
- Principal Investigators Questionnaire: As a part of the notice of intent to review study teams are asked to complete the following questionnaire and return it to HSRC@duke.edu or fax to 919.684.6105. 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 review.
- Faculty Arrival and Departure Flowchart and HR Termination Transfer Checklist
Clinical Trials Billing
The HSRC section performs billing reviews, participates in study initiations, and collaborates on special projects with the Duke Office of Clinical Research (DOCR), School of Medicine Finance Office, and the Patient Revenue Management Organization (PRMO). These reviews may be submitted to the IRB and other institutional officials. These reviews serve as a confidential quality assurance measure internal to the institution.
Campus Institutional Review Board
The Campus Human Subjects Protections Program works with investigators to protect the rights and welfare of research participants. Program staff will pre-review submissions to the Institutional Review Board for non-medical research, providing feedback, consultation, and interpretation of applicable regulations. Program staff also offer seminars about research ethics and the IRB review process for undergraduate and graduate students.
Duke Policy of the Academic Council - A statement of principles and a procedural section is included in this policy. It provides specific protections for student and Duke employees in order to avoid the potential for coercion, however unintended, of those subjects.
Human Subject Research Operational Oversight
Clinical Research Units (CRUs)
The Clinical Research Unit (CRU) is the operating business unit responsible for oversight including integrity, financial accountability, regulatory compliance, quality, and academic productivity of clinical research studies.
The School of Medicine CRUs are the organizational and functional structures that provide support for clinical research in which a Duke Health department, center or institute, CRU or school serves as the investigative sites for the research; or a Duke facility or staff member is responsible for a research activity that involves intervention or interaction with Duke patients, use of biological specimens from Duke patients or access to confidential, private information from Duke patients.
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:
- Clinical Research Units
- 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's firewall.
Medical Center Institutional Review Board (IRB – DUHS)
Human Research Protection Program (HRPP) Policies (link)
The Duke University Health System Institutional Review Board (DUHS IRB) has responsibility for the 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 DUHS IRB has oversight of 9 convened IRBs, 8 which meet monthly in Hock Plaza on the first, second, third and fourth Wednesday and Thursday afternoons of the month.
Their 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.
The Office of Regulatory Affairs and Quality (ORAQ) serves as a no-cost resource to the clinical research community at Duke University Medical Center. The Office offers regulatory and quality assurance support in all aspects of clinical research from preclinical requirements to first-in-human studies and beyond. The office is directed by Dr. Amanda Parrish, who is responsible for overseeing a variety of services designed to support investigators in determining the regulatory and quality requirements that apply to their research. These services include regulatory education, regulatory consultation, and support for regulatory submissions and GMP manufacturing.