Policy
Guidance
- Advertisements [pdf]
- Deception and Incomplete Disclosure [pdf]
- Obtaining Informed Consent [pdf]
- Protocol Deviation [pdf]
- Quality Improvement Projects [pdf]
- Unanticipated Problem and Adverse Event Reporting [pdf]
Ethical Principles
- Nuremburg Code [pdf]: Directives for Human Experimentation
- World Medical Association: Declaration of Helsinki
- The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
Federal Regulations - Protection of Human Subjects
- 45 CFR 46: Protection of Human Subjects
- Subpart A: (The Common Rule) Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for Protection on Human Research Subjects)
- Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
- Subpart C: Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
- Subpart D: Additional DHHS Protections for Children Involved as Subjects in Research
- 21 CFR 50: Protection of Human Subjects
Federal Laws and Regulations Related to Human Subjects Research
- Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
- FERPA: Family Educational Rights & Privacy Act
- Certificates of Confidentiality
- Research Involving Coded Information or Biological Samples