Guidance & Regulations Links

Federal Regulations

U.S. Department of Health & Human Services (HHS) 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 the Inclusion of Women and Minorities in research
• Inclusion of Children in Research
• Research Involving Individuals with Questionable Capacity to Consent

Office for Civil Rights (OCR

• HIPAA-Health Information Privacy for Research
• Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule

Ethical Codes

• Belmont Report
• World Medical Association Declaration of Helsinki

Organizations

• Public Responsibility in Medicine and Research (PRIM&R)
  PRIM&R is committed to the advancement of strong research programs and to the consistent application of ethical precepts in both medicine and research.

Sites of Interest

• NIH Bioethics Resources on the Web
• NIH National Human Genome Research Institute (NHGRI)
• President's Council on Bioethics

Guidance in Research

• "CABLES": Guidance on assessing risks in reseach.
• Principal Investigator Considerations for Student Research: Determining when IRB review and approval is needed for student research and what PIs should consider in the design and implementation of these projects.
• Frequently Asked Questions (FAQs) for International Research: This guidance document covers common issues in international research, including pitfalls and areas that can hold-up IRB review and approval.
• International Compilation of Human Research Protections: A comprehensive guide to laws, regulations, and guidelines that govern human subjects research in 101 countries.
• HHS: Expedited Review Categories: 9 Categories of Research that may be Reviewed by an IRB by Expedited Procedure
• ClinicalTrials.gov: A registry and results database of federally and privately supported clinical trials conducted in the United States and around the world.