Institutional Review Board
IRB Policy, Guidance and Regulation

Resources
The following websites are resources for individuals who work with human subjects. These sites will provide you with an understanding of the Federal Regulations for Human Subjects Research as well as an ethical background for practicing research.

Belmont Report
Office for Human Research Protection (OHRP)
FDA Information Sheets
FDA Brochure for Clinical Investigators
45 CFR 46 (The Common Rule)

IRB Policies and Procedures

OHRP Guidance Documents

Research Ethics Consultation Program
The Program in Bioethics, Health, and Society of the WFU Translational Science Institute offers a Research Ethics Consultation Program (RECP) as a resource for investigators and others involved in all aspects of research.  RECP is a confidential, advisory-only service that responds to inquiries about ethical issues in the design and conduct of research and dissemination of research results.   The RECP team works with consultation requesters to address questions, provide advice and education, and facilitate discussion with the IRB and/or other oversight bodies.  RECP’s role is complementary to that of the IRB and not a substitute for consultation with the IRB.  The RECP team can be reached at RECP@wfubmc.edu.

Compensating Research Subjects
  Compensation for Research Participants
  Procedures for Selecting and Paying Human Study Participants (internal only)
  Research Subject Compensation Form

Database Security

WFUHS Investigator Guidance on Transfer of Data

WFUHS Guidance Document on Protocol Deviations

Clinical Trial Registration