• About IRB
• Federal Regulations
• Ethical Principles
• Policies & Guidelines
• NIH Online Training
• Submission Information
• Forms & Applications
• Post Approval Monitoring (Auditing)
• Meeting Schedule
• Meeting Minutes
• IRB Committee
• External Resources

 

IRB Institutional Official
Dr. Tom Eaves
Associate Provost
Clayton State University
2000 Clayton State Blvd.
Morrow, GA 30260
Phone: 678-466-4100
irb@clayton.edu
 

External Resources for Researchers

Federal Policies and Guidelines
Food and Drug Administration
Data Safety and Monitoring
Ethics and Human Participants in Research
Related Resources

Federal Policies and Guidelines

• IRB Guidebook
• Code of Federal Regulations - 45 CFR
• Office for Human Research Protections - OHRP | En Español
• Office for Human Research Protections (OHRP) 2007 International Compilation of Human Research Protections (PDF)
• Office for Human Research Protections/Department of Health and Human Services - Guidance on Reviewing and Reporting Unanticipated Problems and Adverse Events (PDF)
• Certificates of Confidentiality Kiosk - National Institutes of Health
• NIH Required Education in the Protection of Human Participants
• National Institutes of Health - FAQs regarding Human Participant Research

Food and Drug Administration

• Guidance for IRBs and Clinical Investigators
• Protection of Human Subjects
• Institutional Review Boards
• Investigational New Drug Application
  • Drug Application Form 1571
  • Drug Application Form 1572
• Biological Products
• Investigational Devise Exemptions
• FDA Centers
  • Center for Biologics Evaluation and Research (CBER)
  • Center for Drug Evaluation and Research (CDER)
  • Center for Devices and Radiological Health (CDRH)

Data Safety and Monitoring

• Generic Monitoring Plan for Trials Requiring a Data Safety Monitoring Board
• NIH Policy for Data and Safety
• Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials

Ethics and Human Participants in Research

• Belmont Report
• Nuremberg Code
• Declaration of Helsinki
• American Psychological Associations Code of Ethics

Related Resources

• IRB Forum: Institutional Review Board - Discussion and News Forum
• PRIM&R: Public Responsibility in Medicine and Research
• Get Research Smart (for potential research participants)
• Becoming a Research Volunteer
• Whittle, et. al. (2004). Institutional review board practices regarding assent in pediatric research. Pediatrics, 113(6).  Retrieved from: http://www.pediatrics.org/cgi/content/full/113/6/1747
• Association for the Accreditation of Human Research Protection Programs (AAHRPP)
• National Human Research Protections Advisory Committee (NHRPAC)
• Secretary's Advisory Committee on Human Research Protections (SACHRP)