Human Subjects Research ~ Laws, Policies and Guidelines

Federal Regulations

Office for Human Research Protections (OHRP)

• 45 CFR 46: Protection of Human Subjects

U.S. Food and Drug Administration (FDA)

• 21 CFR 50: Protection of Human Subjects
• 21 CFR 56: Institutional Review Boards

Federal Guidelines

National Institutes of Health (NIH)

• 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 and Human Services (HHS) ~ Office for Civil Rights (OCR)

• HIPAA – National Standards to Protect the Privacy of Personal Health Information

Federal Advisory Committee on Human Subjects Research

• Secretary's Advisory Committee on Human Research Protections (SACHRP)

Office for Human Research Protections (OHRP)

• IRB Guidebook
• Human Subject Regulations Decision Charts

University of Mississippi Institutional Review Board (IRB)

• Federalwide Assurance (FWA) for the Protection of Human Subjects
• A Researcher's Guide to Human Subjects Protection
• UM Policy and Procedures for Waiver of IRB Application for Class Projects
• UM Policy on Mandatory Online Training
• UM Policy on Research in Schools and Other Organizations
• Oral History Guidance

Ethical Principles and Guidelines for Human Subjects Research

• Nuremberg Code (1949)
• Declaration of Helsinki (1964)
• Belmont Report (1997)