IRB Policies and Procedures

These resources will help you navigate the NMDP Institutional Review Board (IRB) policies and procedures.   

• NMDP IRB Materials Required for Review S00038 (PDF)
• Investigator Responsibilities S00048 (PDF)
• Unanticipated Problems Involving Risks to Participants or Others S00407 (PDF)
• Managing and Reporting Non-Compliance with Human Research Protecting Programs Requirements S00213 (PDF)
• Suspension, Termination, and Administrative Closure of Research S00399 (PDF)
• IRB Reliance Agreements and Coop IRB Reviews S00592 (PDF)
• NMDP IRB Protocol Exceptions and Deviations S00693
  

DHHS, OHRP, and FDA Federal Regulations and Guidance

• DHHS regulations on the Protection of Human Subjects (45 CFR 46) 
• OHRP guidance documents
• FDA regulations on the Protection of Human Subjects (21 CFR 50)
• FDA regulations on Institutional Review Boards (21 CFR 56)
• FDA guidance documents