IRB Member Resources

The following resources are available for IRB members.

General Information

• How to Review a New IRB Protocol (PDF)
• Criteria for IRB Approval of Human Research (PDF)
• Consent Elements (PDF)
• Documentation for Children as Research Participant (Word)
• Placebo Documentation (Word)
• Medical Device Documentation (Word)
• Genetic Testing Reviewer Checklist (Word)
• Expedited and Exempt Categories of Human Research (PDF)

Research Ethics, History and International Protections

• Nuremburg Code (PDF)
• The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Participants of Research
• The Declaration of Helsinki (PDF)
• OHRP International Compilation of Human Research Standards
• Presidential Commission for the Study of Bioethical Issues–IRB Primer: Incidental and Secondary Findings (PDF)

Government Agencies and Commissions

• Office for Human Research Protections
  • OHRP Policy and Guidance: Institutional Issues
  • OHRP Mini-Tutorials: Human Subjects Regulations and Policy 
  • OHRP Video: Research Use of Human Biological Specimens and Other Private Information
• Food and Drug Administration Website
  • FDA Clinical Trials Guidance Documents
  • Institutional Review Boards Frequently Asked Questions: FDA Information Sheet

Organizations

• Centerwatch Clinical Trials Network
• Public Responsibility in Medicine and Research (PRIM&R)