Links
- Human Subjects Information Links
Resources: Lay Language for Consent Forms
- Glossary of Medical Lay Terms, Univ. of California at Davis
Clinical Trial Registration
- Clinical Trials. Gov
- ClinicalTrials.gov Protocol Registration System
A public registry option for trials that require registration by law or as a condition for publication.
To include a trial on this registry you will need to apply for an individual account. Use 'Penn State College of Medicine, Penn State Milton S. Hershey Medical Center’ when asked for your affiliate or facility.
- For Penn State Hershey registration steps see - Clinical Trials Registration (internal only)
- ClinicalTrials.gov Protocol Registration System
- International Committee of Medical Journal Editors (ICMJE)
For information on registration requirements for publication.
Ethical Principles of Human Subjects Protection
- The Belmont Report
Ethical Principles on which the U. S. system of human subjects protection is based. - The Nuremberg Code
Ethics code developed during the military war crimes trial. - Declaration of Helsinki
The World Medical Association's ethical principles for medical research involving human subjects. - Historical Article - Ethics & Clinical Research, H. Beecher, M.D.
Federal Agencies Guidelines and Regulations
- Office of Human Research Protections
- Office of Civil Rights
- Food & Drug Administration
- FDA Information Sheets: Guidance for IRBs and Clinical Investigators
- (21 CFR 50) Protection of Human Subjects
- (21 CFR 56) Institutional Review Boards
- (21 CFR 312) Investigational New Drug Application
- (21 CFR 600) Biological Products
- (21 CFR 812) Investigational Device Exemptions
- FDA Certificate of Confidentiality (COC) - COC for IND Studies Biologic IND Studies