IRB Policies and Procedures

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

• IRB Approval of Consent Documents (DOC)
• S00038 (rev 11) NMDP IRB Materials Required for Review (PDF)
• S00048 (rev 8) Investigator Responsibilities (PDF)
• S00407 (rev 9) Unanticipated Problems Involving Risks to Participants or Others  (PDF)
• S00213 (rev 11) Managing and Reporting Non-Compliance with Human Research Protecting Programs Requirements  (PDF)
• S00399 (rev 7) Suspension, Termination, and Administrative Closure of Research (PDF)
• S00592 (rev 7) IRB Reliance Agreements and Coop IRB Reviews (PDF)
• S00693 (rev 4) Protocol Exceptions, Deviations, and Temporary Variances. (PDF)
• P00019 (rev 7) Activities Subject to IRB Jurisdiction (PDF)
• P00054 (rev 2) Advertisements for Recruiting Subjects (PDF)
• P00069 (rev 5) Applicable Federal State Laws Regarding HSR (PDF)
• S00035 (rev 10) IRB General Policy (PDF)
• S00036 (rev 9) NMDP IRB Orientation and Training (PDF)
• S00040 (rev 15) IRB Protocol Review (PDF)
• S00041 (rev 12) IRB Expedited Emergency Exempt (PDF)
• S00045 (rev 10) General Consenting Requirements (PDF)
  

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