General Information

• OHRE Home
• What's New
  (updated 21-July-2009)
• About OHRE
• Regulatory Documents
• Contact OHRE/IRBs

For Investigators

• Guide to IRB Process
• IRB Forms
• Required Human Research Ethics Training
• Dates & Deadlines
• Check IRB Status at My Research at Carolina
• Links

For Research Participants and the Public

• For Participants
• For Students
• For Kids

Links

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

Other Links at UNC-CH Related to Human Subjects Research

• IRB Review Fee for Industry-Sponsored Studies
• Clinical Translational Research Center (CTRC) Guidance and Forms
• Environment, Health and Safety
  • Radiation Safety and the Radiation Safety Committee
  • Biological Safety and the Institutional Biosafety Committee
• Oncology Protocol Review Committee
• Investigational Drug Service (IDS) Note: This web site is on an intranet, and access may not be possible from some locations.
• Office of Clinical Trials
• Registering an Investigator-Initiated Clinical Trial in a Public Registry
• Conflict of Interest Policy
• UNC-CH NC TraCS Institute DSMB
• Information for Researchers from Research at Carolina

Ethical Basis, Historical Documents, International Protections

• Nuremberg Code
• The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research
• The Declaration of Helsinki (the World Medical Association)
• Federal Office for Human Research Protections' International Compilation of Human Subject Research Protections, a listing of the laws, regulations, and guidelines that govern human subjects research in many countries around the world.
• Reports from national bioethics commissions (1974-present)

Federal Office for Human Research Protections

• Office for Human Research Protections. Federal agency that regulates IRBs and human subjects research. Spanish version of key parts of OHRP web.
• 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
  • FDA Information Sheets: Guidance for IRBs, and Clinical Investigators and Sponsors
  • FDA Guidance on Adverse Event Reporting to IRBs
  • Investigational Device Exemption (IDE)
  • Drug Approval Application Process
  • Expedited Review List
  • Frequently Requested ORA Documents under FOIA
  • Index of Categories of Documents for Electronic Reading Room
  • Information for Clinical Investigators
  • Regulatory Guidance
• National Institutes of Health
• IRBs and HIPAA Privacy Rule
• Ethical Issues in Research Involving Human Participants
• Office of Biotechnology Activities
• National Cancer Institute
• National Human Genome Research Institute
• National Institutes of Environmental Health Sciences
• National Library of Medicine
• Information about the Certificate of Confidentiality

Non-Governmental Organizations

• American Council on Science and Health
• Applied Research Ethics National Association (ARENA) and Public Responsibility in Medicine and Research (PRIM&R)
• Association for the Accreditation of Human Research Protection Programs (AAHRPP)
• "Reaching Beyond Regulations: The Pursuit of Accreditation for Human Research Protection Programs." Lynn E. Smith, JC. CIM, CIP. Monitor, June 2008, 67-70.
• Association of American Medical Colleges
• Association of American Universities
• Children's Hospital Boston's Interactive Parents' Guide to Medical Research
• Family Health International. See their Research Ethics Training Curriculum
• Harvard Program on Ethical Issues in International Health Research
• The Hastings Center
• Kennedy Institute of Ethics
• National Academy of Sciences
• Institute of Medicine
• National Research Council
• Poynter Center for the Study of Ethics and American Institutions, Indiana University
• Prisoners as Subjects--A Reference Guide for Clinical Researchers, University of Louisville School of Medicine

Newsletters and Additional Materials

• Clinical Trials Administrator
• Human Research Report
• IRB Advisor
• IRB: Ethics and Human Research. From the Hastings Institute
• The IRB Forum. Discussion and news forum for IRB members, staff and others
• Resources for IRB "Community" Members from the U.S. Department of Energy

Other

• Glossary. Primarily medical terminology--may be useful in writing consent forms with less jargon
• Glossary of Terms. General IRB-related terminology explained. From the IRB Guidebook by the Office for Human Research Protections (OHRP)
• Language Translation Services

Updated Thursday, November 12, 2009.
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