Federal and State Regulations & Guidance Materials for Human Subjects Research

OHRP – Office for Human Research Protections

• 45 CFR 46 – Federal Regulations for the Protection of Human Subject – applies to ALL human subjects studies

NIH – National Institutes of Health

• Education Requirement – FAQs regarding the NIH Education Requirement
• Special Topics:
  • Certificates of Confidentiality
  • Data Sharing
  • Inclusion Policies for Research Involving Human Subjects
  • Single IRB

NSF – National Science Foundation

• Human Subjects – NSF Policy for human subjects research (HSR)
• Behavioral and Social Science Research – NSF interpretation of Common Rule and Behavioral and Social Science Research

FDA – Food and Drug Administration

Studies using investigational drugs, devices or biologics

• 21 CFR 50 – FDA Regulations for Protection of Human Subjects
• 21 CFR 56 – FDA Regulations for Institutional Review Boards
• Guidance for interpreting 21 CFR 50 and 56
• Comparison of FDA and HHS Human Subject Regulations

VHA – Veterans Health Administration

• ORO – Office of Research Oversight

HIPPA Regulations

• 45 CFR 160, 162 and 164

DoD – Department of Defense

• DoD Directives
• DoD Instruction

General

• The Belmont Report
• The Nuremberg Code
• Declaration of Helsinki (“The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects.”)
• The Common Rule – Federal Policy for the Protection of Human Subjects