IRB Applications and Forms

Use the appropriate form below to submit a study to the NMDP Institutional Review Board (IRB), request NMDP IRB approval for a change to a study, close an IRB-approved study, or report potential unanticipated problems or potential non-compliance to the NMDP IRB.

Additional resources and forms for sites using the NMDP IRB as a single IRB are also found below.

• Application for Initial Review: Bio-Medical Studies - Transplant Center Sponsored Research  (DOC)
  Complete this application for bio-medical study protocols that are initiated/sponsored by a transplant center and require initial NMDP IRB review.  This application should be used for studies when the only reason for submitting the study to the NMDP IRB is because unrelated donors are considered human research subjects on the protocol.  This application does not need to be completed if the study does not involve unrelated donors as human subjects, or if the protocol includes the use of data from the NMDP/CIBMTR Research Database or samples from the NMDP/CIBMTR Research Sample Repository.
• Guidance for Completing Initial Application for Bio-Medical Studies - Transplant Center Sponsored Research (DOC)
  Use this guide to help you complete the NMDP Application for Initial Review: Bio-Medical Studies - Transplant Center Sponsored Research.
• Application for Initial Review: Bio-Medical Studies (DOC)
  Complete this application for bio-medical study protocols that require initial NMDP IRB review and are not initiated/sponsored by a transplant center.  For example, this application should be completed for multi-site studies sponsored by BMT CTN or the CIBMTR RCI BMT program.
• Application for Initial Review: Social & Behavioral Studies (DOC) 
  Complete this application for all social and behavioral study protocols requiring initial NMDP IRB review.
  
• Study Amendment Request (DOC) 
  Complete this form for changes in research previously approved by the NMDP IRB that need to be approved and implemented prior to the next NMDP IRB continuing review.
• IRB StudyClosure Notification (DOC) 
  Complete this form when a study meets the criteria to be closed with the NMDP IRB. 
• NMDP IRB Reportable Event Form (DOC) 
  If your site is relying on the NMDP IRB as your IRB of Record for a study, use this form to report a potential unanticipated problem or potential serious or continuing non-compliance to the NMDP IRB.
• NMDP IRB Major Protocol Exception Request Form (DOC)
  Use this form to request approval from the NMDP IRB for a major protocol exception prior to implementation of the exception.
• Protocol Exceptions and Deviations Log TEMPLATE
  Use this template log to keep track of your major protocol exceptions, minor protocol exceptions, and protocol deviations that need to be reported to the NMDP IRB at the time of continuing review.

Participating as a Study Site Using the NMDP Single IRB 

Institutions participating in Blood and Marrow Transplant Clinical Trials Network^® (BMT CTN) research are required to use the NMDP IRB as their IRB of record for BMT CTN studies.  Institutions participating in studies through the Center for International Blood and Marrow Transplant Research^® (CIBMTR^®) Resource for Clinical Investigation in Blood and Marrow Transplantation (RCI BMT) program may also be required to use the NMDP IRB as their IRB of record, depending on the study.

Below are resources and forms for institutions using the NMDP IRB as a Single IRB (sIRB).  For questions regarding the NMDP Single IRB process, contact NMDPSIRB@nmdp.org. 

• NMDP Single IRB Manual for Local Institutions (PDF)
  This manual provides information for institutions enrolling in and using the NMDP Single IRB.
• IRB Authorization Agreement – All BMT CTN Studies (DOC)
  This IRB Authorization Agreement authorizes a Signatory Institution to rely on the NMDP IRB for all BMT CTN studies.  The document also describes the division of responsibilities between the Signatory Institution and the NMDP IRB.
• IRB Authorization Agreement Template -- 16-NTCD v1.0 (DOC)
  This IRB Authorization Agreement authorizes a Signatory Institution to rely on the NMDP IRB for the RCI BMT 16-NTCD study.  The document also describes the division of responsibilities between the Signatory Institution and the NMDP IRB for this specific study.
•  IRB Authorization Agreement Template RCI BMT 17 e-PRO v1.0 (DOC) 
  This IRB Authorization Agreement authorizes a Signatory Institution to rely on the NMDP IRB for the RCI BMT 17-ePRO study. The document also describes the division of responsibilities between the Signatory Institution and the NMDP IRB for this specific study.
• IRB Authorization Agreement Template -- RCI BMT 17-SIBS v1.1 (DOC)
  This IRB Authorization Agreement authorizes a Signatory Institution to rely on the NMDP IRB for the RCI BMT 17-SIBS study. The document also describes the division of responsibilities between the Signatory Institution and the NMDP IRB for this specific study.
• NMDP Single IRB Signatory Institution Enrollment Form (DOC)
  Use this form to enroll as a Signatory Institution with the NMDP Single IRB.  
• NMDP Single IRB Signatory Institution Local Context Worksheet (DOC)
  Use this form to identify and report to the NMDP IRB local context considerations for the Signatory Institution, such as state and local laws, boilerplate consent language, etc.
• NMDP Single IRB Study-Specific Local Context Worksheet (DOC)
  Use this form to identify and report to the NMDP IRB local context considerations specific to the Principal Investigator or the study, such as subject recruitment, available resources, etc.  This form should be submitted for each study.  
• NMDP Single IRB Study Site Closure Form (DOC)
  Use this form when a study meets the criteria to be closed with the NMDP IRB at your institution.