Resources

Federal Regulations for Protection of Research Subjects:

(45 CFR 46) Code of Federal Regulations for Human Subject Protection

(21 CFR 50) Protection of Human Subjects
(21 CFR 56) Institutional Review Boards

Cancer.net Video Library – Information About Clinical Trials
Video Library

National Cancer Institute:
How You Can Help Medical Research
Registries for Evaluating Patient Outcomes: A User's Guide, 2nd edition
Community-Based Participatory Research
CITI Program
HIPAA Privacy Rule and Its Impacts on Research
Office for Human Research Protections (OHRP)
International Committee of Medical Journal Editors
Food & Drug Administration

Resources: Lay Language for Consent Forms
Glossary (in Lay Terms): Stanford University
Glossary: University of Florida
Investigator AAHRPP Site Prep
NIH-SmartIRB-CommonRule.pdf

The Belmont Report
English

Webinars
Emergency Use and Compassionate Use of Unapproved Devices (approx. 20 minutes)
Expanded Access Training Webinar (materials only)
Humanitarian Use Devices (HUDs) (approx. 20 minutes)

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 
      (21 CFR 600) Biological Products
      (21 CFR 812) Investigational Device Exemptions  

      New Clinical Trial Registration Rule
     
FDA Centers Certificate of Confidentiality (COC)
           -  FDA's Certificates of Confidentiality Application Instructions

Should you have questions, please contact the AdventHealth IRB Orlando at 407-200-2677 or via email at FH.IRB.General@flhosp.org.