Current policies related to the Duke Health IRB and Human Research Protection Program (HRPP) are located here. View the complete list of policies.The policies are below, and you can search for policies in the following categories:
Research Involving Drugs or Biologics
The policy describes how the IRB confirms and documents the presence of an IND for research involving the use of drugs or biologics (other than the use of a FDA approved, marketed drug/biologic in the course of medical practice). IND exemption criteria are outlined.
Retention of Records
This policy explains the retention of IRB records and other documents.
Scientific Validity of a Research Protocol
This policy describes how the IRB, CRU, and other HRPP review committees assess the scientific or scholarly validity of a research protocol.
Significant Risk vs Non-Significant Risk Device Studies
This policy provides definitions for significant risk (SR) device and non-significant risk (NSR) device, and discusses major differences between SR and NSR device studies. The policy explains IRB responsibilities and Investigator/Sponsor responsibilities in making a risk determination for a device study.
Specialty Committee Review Forms
The Duke University Health System Institutional Review Board (DUHS IRB) works in coordination with other University Committees and external review resources to protect the safety and welfare of research participants. This policy describes the different specialty committees, and explains the investigator's responsibilities relating to specialty committee reviews.
State Law for Research
The policy discusses state of North Carolina law terms and principles applicable to human subjects research, including: legally authorized representative, child, and guardian.
Subject Problems, Complaints, Concerns and Questions
This policy defines the process by which problems, complaints, concerns, suggestions, or comments from research participants or research personnel are received, reviewed and processed in the Duke University Health System (DUHS) Institutional Review Board (IRB) Office.
Translation Policy
The policy describes requirements related to the informed consent process in research involving participants who speaks a language other than English. The policy discusses translation requirements, documents needed for IRB review, and use of the short and long form consents.
Unanticipated Problems
This policy describes the events that require prompt reporting to the IRB, and sets out timelines for reporting. The policy offers many examples of problems or events requiring prompt reporting to the IRB.
Undue Influence Upon the IRB
It is the policy of the DUHS IRB that IRB review activities, and the implementation of DUHS IRB policies and procedures, are to be conducted objectively and without undue influence over deliberations or processes.