Government guidelines and reports

DHHS's Protection of Human Subjects - 45CFR46 Title 45--Public Welfare Subtitle A--Department of Human Services 46--Protection of Human Subjects.

Additional DHHS Protections for Children - 45 CFR46.401-409

FDA's Information Sheets -including Frequently Asked Questions

FDA's Investigational New Drug Application - 21CFR312 Title 21 PART 312--INVESTIGATIONAL NEW DRUG APPLICATION of the Code of Federal Regulations

NIH's Guidelines on Fetal Tissue Transplantation NIH - 4/29/94

NIH Guidelines on the Inclusion of Women & Minorities as Clinical Research Subjects

NIH's document on Research - Involving Individuals with Questionable Capacity to Consent

Human Subject Regulations - Decision Charts

Humanitarian Use Devices General Information

Government Agencies

• National Archives and Records Administration Code of Federal Regulations
• Office of Human Research Protections (OHRP)
• Clinical Trials-NIH
• U.S. Food and Drug Administration
• National Bioethics Advisory Commission
• National Institutes of Health