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Institutional Review Board

  • IRB Meeting Schedule
  • Policies and Procedures
  • Donors as Research Subjects
  • IRBManager Info
  • Relying on the NMDP sIRB
  • Study-Level Submissions
  • Decision Charts

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We can help you with questions or concerns.


IRBstaff@nmdp.org
  1. Research
  2. Institutional Review Board
  3. Policies and Procedures

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
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