The Research Sample Repository contains cell and serum samples collected from related and unrelated transplant donors, cord blood units and recipients.

Research goals

The primary objective of the Research Sample Repository is to make these samples available for research studies related to histocompatibility and hematopoietic cell transplantation (HCT).

These data may be used in research to:

• Improve the understanding of tissue matching for HCT donors and recipients
• Determine and evaluate the factors that affect HCT and cellular therapy outcomes
• Study the distribution of HLA tissue types in different populations

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Recipient and donor participation

The Research Sample Repository includes cell and serum samples from allogeneic related and unrelated donors and recipients. The protocol also allows for the submission of research samples from registered donors with rare tissue types. Complete eligibility requirements are outlined in the study protocol.

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IRB requirements

U.S. transplant centers

To be compliant with United States Federal Regulations for human research subject protection, U.S. transplant centers must obtain IRB-approved informed consent from recipients before submitting samples to the Research Sample Repository.

Although all NMDP/Be The Match centers participate in the Research Sample Repository protocol, only select NMDP/Be The Match centers currently submit related recipient and donor samples. In the future, additional NMDP/Be The Match centers may be invited to submit related recipient and donor samples.

If your center only performs related donor HCT and/or autologous HCT, you will not submit research samples, and therefore do not need to obtain IRB approval for your center for the Research Sample Repository protocol.

Upon obtaining center IRB approval, the CIBMTR Protocol Coordinator must receive a copy of the center's IRB approval letter, approved protocol and informed consent documents. These documents should be sent via email to:

RepositoryIRB@nmdp.org

CIBMTR tracks the IRB approval for the Research Sample Repository at each participating center. The center's IRB approval for this protocol must be current at all times. Failure to have current IRB approval may affect your center's ability to meet CPI requirements for sample submission.

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CIBMTR approved protocol and consent forms

The CIBMTR, through the NMDP/Be The Match IRB, has approved the following protocol and consent form templates. Your center must have IRB approval for the protocol and consent forms relevant to your center. The protocol must be submitted as written for center IRB approval.

Repository protocol

• Protocol (PDF)
  
• Record of Revisions (PDF)
  
• Protocol - Redline (PDF)
  

Repository IRB approvals

• NMDP / Be the Match IRB Approval (PDF)
  

Certificate of Confidentiality

• Certificate of Confidentiality (PDF)
  

Repository recipient consent forms

• Adult Consent and Parent/Legal Guardian Permission Related/Unrelated (DOC)
  
• Recipient Minor Assent Form Ages 7-11 (DOC)
  
• Recipient Minor Assent Form Ages 12-17 (DOC)
  

Marrow toxic injury

• Marrow Toxic Injury Adult Consent and Parent / Legal Guardian Permission Form (DOC)
  
• Marrow Toxic Injury Minor Assent Form Ages 7-11 (DOC)
  
• Marrow Toxic Injury Minor Assent Form Ages 12-17 (DOC)
  

Secondary Primary Malignancy (forms required only if center has been directly notified by CIBMTR)

• Secondary Primary Malignancy Adult Consent and Parent / Legal Guardian Permission Form (DOC)
  
• Secondary Primary Malignancy Minor Assent Form Ages 7-11 (DOC)
  
• Secondary Primary Malignancy Minor Assent Form Ages 12-17 (DOC)
  

Repository donor consent forms

Adult allogeneic related/unrelated donor consent form

• English (PDF)
• Chinese (PDF)
  
• German (PDF)
  
• Korean (PDF)
  
• Portuguese (PDF)
  
• Spanish (PDF)
  
• Vietnamese (PDF)