Policies, Regulations and Ethics

University Policy

• University Human Subjects Policy
• University Human Body Fluids Precaution Policy

Federal and State Regulations

• 45 CFR 46 - Protection of Human Subjects - Office for Human Research Protections
• 21 CFR 50 - Protection of Human Subjects - Food & Drug Administration
• Guidelines for Review of Human Subject Research - Massachusetts Department of Public Health

Federal Guidelines

• Office for Human Research Protections (OHRP)
  • Policy Guidance (by Topics)
  • Resources
• HIPAA - National Standards to Protect the Privacy of Personal Health Information
• Secretary's Advisory Committee on Human Research Protections (SACHRP)

Ethical Guidelines

• Belmont Report
• Declaration of Helsinki
• Council for International Organizations of Medical Sciences (CIOMS) - International Ethical Guidelines for Biomedical Research involving Human Subjects

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.

NIH Links

• Links for NIH Office of Human Subjects Research
• Links for NIH Office for Human Research Protections
• Frequently Asked Questions (from NIH)

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