The links below provide useful resources on IRB and related issues.

Links at UNC-CH Related to Human Subjects Research

• Carolinas Collaborative Research Guidance Document
• Clinical Translational Research Center (CTRC) Orientation and Training
• Environment, Health and Safety
  • Radiation Safety and the Radiation Safety Committee
    • Five or fewer FDA approved or cleared scans/x-rays do not need Radiation Safety Committee approval
  • Biological Safety and the Institutional Biosafety Committee
• Oncology Protocol Review Committee
• Clinical Trials Office
• Registering an Investigator-Initiated Clinical Trial in a Public Registry
• Conflict of Interest:
  • Policy on Individual Conflicts of Interest and Commitment
  • Policy on Institutional Conflict of Interest
• UNC Data and Safety Monitoring Board (DSMB)
• Information for Researchers from Research at Carolina
• HIPAA Research Policy

Federal Office for Human Research Protections

• Office for Human Research Protections. Federal agency that regulates IRBs and human subjects research.
• The Code of Federal Regulations (45CFR46). Federal regulations governing protection of human subjects
• OHRP Guidance on Unanticipated Problems and Adverse Events
• OHRP’s Frequently Asked Questions
• Expedited Review Categories of Research
• IRB Guidebook
• OHRP Policy Guidance by Topic
• OHRP Guidance on Coded Private Information and Biological Specimens
• NIH Decision Chart on Applying OHRP Guidance on Coded Info/Specimens
• Engagement of Institutions in Research
• Links to reference documents, historical materials and Common Rule departments/agencies. A list maintained by OHRP.

Other Federal Agencies

• Centers for Disease Control and Prevention
• Department of Education
• Department of Health and Human Services
  • Office for Civil Rights – HIPAA
  • Office of Research Integrity
• Food and Drug Administration
  • 21CFR50. FDA regulations for protection of human subjects
  • 21CFR56. FDA regulations governing IRBs
  • Investigational Device Exemption (IDE)
  • Drug Approval Application Process
  • Information for Clinical Investigators
  • FAQs about Medical Devices
• National Institutes of Health
• Ethical Issues in Research Involving Human Participants
• National Cancer Institute
• National Human Genome Research Institute
• National Institutes of Environmental Health Sciences
• National Library of Medicine

Non-Governmental Organizations

• American Council on Science and Health
• Public Responsibility in Medicine and Research (PRIM&R)
• Association for the Accreditation of Human Research Protection Programs (AAHRPP)
• Association of American Medical Colleges
• Association of American Universities
• Harvard Program on Ethical Issues in International Health Research
• The Hastings Center
  • Ethics & Human Research
• Kennedy Institute of Ethics
• National Academy of Sciences
• Institute of Medicine