Resources: Lay Language for Consent Forms

• Glossary of Medical Lay Terms, Univ. of California at Davis
• Glossary (in Lay Terms) NYU School of Medicine

Clinical Trial Registration

• Clinical Trials Registration - Information about clinical trial registration requirements (internal only).

   

• ClinicalTrials.gov Protocol Registration System
  A public registry option for trials that require registration by law or as a condition for publication for ICMJE.

   

  • 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 affiliation or facility. 

   

• 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
  • (45 CFR 46) Code of Federal Regulations for Human Subject Protection 
• 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
    • Drug Application Form 1571and 1572
  • (21 CFR 600) Biological Products
  • (21 CFR 812) Investigational Device Exemptions
  • New Clinical Trial Registration Rule
  • FDA Centers
    • Device Advice
    • Center for Biologics Evaluation and Research (CBER)
    • Center for Drug Evaluation and Research (CDER)
  • Certificate of Confidentiality (COC) -  FDA's Certificates of Confidentiality Application Instructions.
• National Institutes of Health (NIH)
  • ONIH-NCI Tutorial - Human Participant Protections Education for Research Teams
  • Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications
  • NIH Certificate of Confidentiality Kiosk