Please be aware that the changes to the federal regulations that govern human subjects research go into effect on January 21st, 2019. Please see our Standard Operating Procedures for this transition to see how these changes will affect your research.
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)