- Human Subjects Information Links
Clinical Trial Registration
- Clinical Trials. Gov: Public registry for trials requiring registration by law or as a condition of publication.
For individual accounts, list 'Penn State College of Medicine, Penn State Milton S. Hershey Medical Center' as the affiliate/facility.
For more details contact the Research Quality Assurance Office.
- International Committee of Medical Journal Editors (ICMJE): Registration requirements for publication
Ethical Principles of Human Subjects Protection
- The Belmont Report: Ethical foundation for the U.S. system of protection for human subjects of research
- The Nuremberg Code: Ethical code created during military war crimes tribunal
- Declaration of Helsinki: World Medical Association ethical principles
- Ethics and Clinical Research historical article by Henry K. Beecher, M.D.
Federal Agencies Guidelines and Regulations
- Federal regulations for the protection of human subjects of research
- OHRP - (45 CFR 46) Code of Federal Regulations for Human Subject Protection
- FDA - (21 CFR 50) Protection of Human Subjects and (21 CFR 56) Institutional Review Boards
- Office of Human Research Protections
- Food & Drug Administration
- (21 CFR 312) Investigational New Drug Application IND Form 1571 and 1572
- (21 CFR 600) Biological Products
- (21 CFR 812) Investigational Device Exemptions
- FDA Certificate of Confidentiality (COC) - FDACOC Instr COC for IND Studies COC Biologic IND Studies
- FDA Information Sheets: Guidance for IRBs and Clinical Investigators
- National Institutes of Health (NIH)
- Certificate of Confidentiality - NIH Certificate of Confidentiality Kiosk
- NIH-NCI Tutorial - Human Participant Protections Education for Research Teams
- NIH Policy - Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications
- Office of Civil Rights - Health Information Privacy rules