Policies, Regulations and Ethics

University Policy

• University Human Subjects Policy
• University Human Body Fluids Precaution Policy
• Conflict of Interest relating to Human Subjects Research (UMass President's Office)
• Conflict of Interest relating to Human Subjects Research (UMass Medical)
• Faculty Consulting and Outside Activities (T96-047)
• Roles & Responsibilities of Principal Investigators/Co-Investigators (Who Can be a PI?)

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.

NIH Links

• Links for NIH Office of Human Subjects Research
• Office for Human Research Protections (OHRP)