Regulatory Requirements

OHRP 45 CFR 46 Regulations
FDA Regulations for Protection of Human Subjects

Regulatory Guidance

OHRP IRB Guidebook
Guidance on Coded Private Information or Biological Specimens
International Compilation of Human Research Protections
Engagement of Institutions in Research
Belmont Report Ethical Principles
Declaration of Helsinki Ethical Principles
The Nuremberg Code Ethical Principles

Informed Consent

OHRP Informed Consent Checklist
OHRP Informed Consent FAQ
OHRP Informed Consent Requirements (Video)
OHRP Informed Consent Tips

Vulnerable Populations

OHRP Prisoner Research Guidance
OHRP FAQs on Prisoner Research
OHRP Special Issues for Children
OHRP FAQs on Children Research
OHRP Guidance on the “407” Review Process for Children
OHRP Guidance on Certificates of Confidentiality
OHRP AIDS Research

FDA Regulatory Information

FDA Human Subject Guidelines
Frequently Asked Questions About Medical Devices
Significant Risk and Nonsignificant Risk Medical Device Studies