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)
- 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.
