IRB Member and Guidance Documents

• IRB Overview
• IRB Member Agreement
• Recusal Policy for IRB Members
• Policy and Procedures on Conflicts of Interest in Research

Protocol Review Guidance

• Reviewing a new IRB Protocol
• Reviewing a Consent Form
• Evaluation of Research Worksheet (Primary Reviewer Sheet)
• OHRP IRB Guidebook on Human Subject Protections
• FDA Guidance for IRBs and Clinical Investigators 
• Recruitment of Subjects
• Knowledge of Local Research Context
• DSMP Guidance for IRB Members

Ethical Principals

• The Belmont Report
• The Nuremberg Code
• Declaration of Helsinki

Regulations

• 45 CFR 46
• §46.101(b) [Exemption Categories] 
• 63 FR 60364-60367 [Expedite Categories] 
• FDA Regulations [Reference List]

FWA

• Federal-wide Assurance Information
• Federal-wide Assurance Compliance Letter

Related Articles

• UT Southwestern Compliance Notes – HIPAA and Research Subject Recruitment
• Research with Children and Minors
• Assent in Pediatric Research
• Variation in Standards of Research Compensation and Child Assent Practices
• The Conduct of Phase 1 Trials in Children – NCI Investigator’s Handbook
• Guidance on IRB Review of Clinical Trial Websites – DHHS Guidance 9/2005
• What Makes Clinical Research Ethical
• Research Compensation and the Monetarization of Medicine
• Managing Conflicts of Interest in the Conduct of Clinical Trials
• Heath Industry Practices That Create Conflict of Interest

Resources on the Web

• PRIM&R the premier organization for those committed to promoting the highest ethical standards in the conduct of research
• PRIM&R: Hot Topics for IRBs
• IRB Forum Member web site and e-mail list to promote the discussion of ethical, regulatory and policy concerns with human subjects research.
• BioEthics.net The American Journal of Bioethics provides a rapid, peer–reviewed collection of scholarship about emerging issues in bioethics.