Research Sample Repository Protocol and Consent Forms
The National Marrow Donor Program® (NMDP) Research Sample Repository contains cell and serum samples collected from related and unrelated transplant donors, cord blood units and recipients.
Research goals
Recipient and donor participation
IRB requirements
CIBMTR approved protocol and consent forms
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 outcomes
- Study the distribution of HLA tissue types in different populations
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 submission of research samples from registered donors with rare tissue types. Complete eligibility requirements are outlined in the study protocol.
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 centers participate in the Research Sample Repository protocol, only select NMDP centers currently submit related recipient and donor samples. In the future, additional NMDP 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 local IRB approval for the Research Sample Repository protocol.
Upon obtaining local IRB approval, the NMDP IRB Office must receive a copy of the local IRB’s approval letter, approved protocol and informed consent documents. These documents should be sent to:
Christina Jobe, Program Specialist
National Marrow Donor Program
3001 Broadway Street N.E., Suite 110
Minneapolis, MN 55413
E-mail: cjobe@nmdp.org
Telephone: (612) 627-8164
Fax: (612) 627-5899
The NMDP IRB Office tracks the IRB approval for the Research Sample Repository at each participating center. Your center will receive a renewal reminder approximately two months in advance of the local continuing review date. Local IRB approval for this protocol must be current at all times. Failure to have current local IRB approval may affect your center’s ability to meet CPI requirements for sample submission.
CIBMTR approved protocol and consent forms
The CIBMTR, through the Medical College of Wisconsin (MCW) IRB and in conjunction with the NMDP IRB have approved the following protocol and consent forms. Your center must submit these documents to your local IRB for review and approval. CIBMTR and NMDP allow the consent forms to be formatted according to each site’s requirements, but requires the protocols to be submitted as written.
Repository protocol
Repository IRB approvals
Repository recipient consent forms
Allogeneic transplants
- Adult Allogeneic - Related/Unrelated Consent Form (DOC)
- Minor Allogeneic - Related/Unrelated Recipient Parent/Legal Guardian Permission Form & Minor Assent Forms (DOC)
Marrow toxic injury
- Adult Marrow Toxic Injury - Research Sample Consent Form (DOC)
- Minor Marrow Toxic Injury - Parent/Legal Guardian Permission Form & Minor Assent Forms (DOC)
Repository donor consent forms
Adult allogeneic related/unrelated donor consent form
The donor consent form is currently being translated, and will be posted when it becomes available. In the meantime, federal regulations allow for the use of a Short Form when a fully translated consent form is not available. If you need a Short Form, please contact Christina Jobe at 612-627-8164 or cjobe@nmdp.org.
Miscellaneous forms
- Minor Allogeneic Related - Parent/Legal Guardian Donor Permission Form & Minor Assent Forms (DOC)
- Rare HLA Consent Form (DOC)
- Match Algorithm Enhancement - Adult Registered Donor Consent Form (DOC)
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