Userful Links

Regulations & Ethics

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 54 - Financial Disclosure by Clinical Investigators
• 21 CFR 56 - Institutional Review Boards
• 21 CFR 312 - Investigational New Drug Application
• 21 CFR 812 - Investigational Device Exemptions

National Institutes of Health (NIH)

• Public Law 110-85 - Mandatory ClinicalTrials.gov Registration

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 & Humans 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)

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.
• Applied Research Ethics National Association (ARENA)
  ARENA is a national membership organization for professionals concerned with issues relating to the protection of human subjects, the humane care and treatment of animals, scientific misconduct, ethical decision-making in healthcare, and other ethical issues pertaining to biomedical and behavioral research.

Other Sites of Interest

• University of Minnesota Center for Bioethics
• NIH Bioethics Resources on the Web
• Secretary's Advisory Committee on Human Research Protections (SACHRP)
  provides advice and recommendations on issues pertaining to or associated with the protection of human research subjects
• President's Council on Bioethics
• Bioethics.net
• Human Genome Project