The Office of

Human Research Ethics

General Information

For Investigators

For Research Participants and the Public

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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
General Clinical Research Center (GCRC) 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 School of Medicine DSMB
A page of additional links to UNC-CH sites relevant to the researcher
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Ethical Basis, Historical Documents, International Protections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
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
- Guidance for IRBs and Clinical Investigators
- FDA Guidance on Unanticipated Problems and Adverse Events
- 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

Non-Governmental Organizations

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