External Resources for Researchers

Federal Policies and Guidelines

• IRB Guidebook
• Code of Federal Regulations - 45 CFR
• Office for Human Research Protections (OHRP) International Compilation of Human Research Standards
• Office for Human Research Protections/Department of Health and Human Services - Guidance on Reviewing and Reporting Unanticipated Problems and Adverse Events (PDF)
• Certificates of Confidentiality Kiosk - National Institutes of Health
• National Institutes of Health - FAQs regarding Human Participant Research

Food and Drug Administration

• Protection of Human Subjects
• Institutional Review Boards
• Investigational New Drug Application
• Biological Products
• Investigational Device Exemptions

FDA Centers

• Center for Biologics Evaluation and Research (CBER)
• Center for Drug Evaluation and Research (CDER)
• Center for Devices and Radiological Health (CDRH)

Data Safety and Monitoring

• Generic Monitoring Plan for Trials Requiring a Data Safety Monitoring Board
• NIH Policy for Data and Safety
• Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials

Ethics and Human Participants in Research

• Belmont Report
• Nuremberg Code
• Declaration of Helsinki
• American Psychological Associations Code of Ethics

Related Resources

• IRB Forum: Institutional Review Board - Discussion and News Forum
• PRIM&R: Public Responsibility in Medicine and Research
• Becoming a Research Volunteer
• Pediatrics
• Association for the Accreditation of Human Research Protection Programs (AAHRPP)
• National Human Research Protections Advisory Committee (NHRPAC)
• Secretary's Advisory Committee on Human Research Protections (SACHRP)