These resources may be helpful in preparing protocol applications.
- Health and Human Services Regulations on Protection of Human Subjects
- Food and Drug Administration Regulations
- FDA Information Sheets (Guidance for Institutional Review Boards and Clinical Investigators)
- Federal Office for Human Research Protections/HHS
- Federal HIPAA regulations (Department of Health and Human Services National Standards to Protect the Privacy of Personal Health Information)
- NIH Clinical Trial Requirements (NIH Definition of clinical trial)
- NIH Single IRB Policy (Single IRB Policy for Multi-site Research)
- Public Responsibility in Medicine and Research (PRIM&R)
- Regulatory Affairs Professional Society (RAPS)
- The Belmont Report (Ethical principles and guidelines for the protection of human subjects of research)