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)
Please see the following resources that pertain to the Revised Common Rule, which went into effect on 01/21/2019: