Regulatory Links Download HRPP SOPs Clinical Trials Find a Researcher Federal Regulations Office for Human Research Protections (OHRP) Protection of Human Subjects (45 CFR 46) U.S. Food and Drug Administration Protection of Human Subjects (21 CFR 50) Financial Disclosure by Clinical Investigators (21 CFR 54) Institutional Review Boards (21 CFR 56) Investigational New Drug Application (21 CFR 312) Investigational Device Exemptions (21 CFR 812) Federal Guidelines National Institutes of Health Guidelines on Women and Minorities Inclusion of Women and Minorities as Participants in Research Involving Human Subjects (Policy Implementation Page) Inclusion of Children Policy Implementation Research Involving Individuals with Questionable Capacity to Consent: Points to Consider U.S. Department of Health & Humans Services Office for Civil Rights (OCR) National Standards to Protect the Privacy of Personal Health Information (HIPAA) Secretary's Advisory Committee on Human Research Protections Informed Consent Posting Guidance (OHRP) CITI Final Rule Resources OHRP Revised Common Rule Educational Resources Ethical Codes Belmont Report