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
- http://www.pediatrics.org/cgi/content/full/113/6/1747
- 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)