NMDP Data Collection and Research Sample Repository Protocols
To be compliant with Federal Regulations for human research subject protection, sites must obtain IRB-approved informed consent from recipients and donors to allow data submitted to the Stem Cell Therapeutics Outcomes Database (SCTOD) to be used for research. Informed consent must also be obtained from recipients and donors prior to submitting blood samples to the Research Sample Repository. The NMDP/CIMBTR has written protocols and informed consent documents for the Research Database and Research Sample Repository. All centers must have local IRB approval for the Research Database protocol. All centers that are NMDP member centers must also have local IRB approval for the Research Sample Repository protocol. Centers performing only related donor transplants and/or autologous transplants will not be submitting research samples and do not need to obtain local IRB approval for the repository protocol. The NMDP and Medical College of Wisconsin (MCW) IRBs have approved these protocols and consent forms and the documents are provided to participating sites to include with their local IRB submissions.
Under new federal legislation, U.S. centers are required to submit outcomes data on all allogeneic transplants, related and unrelated. Data submitted without informed consent from the recipient will only be used for federally required research such as the center-specific outcomes analysis.
Research Database
The Research Database includes submission of recipient baseline and outcome data for allogeneic transplants, related and unrelated from any cell source, and autologous transplants. In addition, the protocol also includes submission of unrelated donor outcomes data and data on individuals with a marrow toxic injury.
- Protocol (PDF)
- Record of Revisions (PDF)
- IRB Approval
See Also: Donor Consent Forms, Recipient Consent Forms
Research Sample Repository
The Research Repository includes submission of research blood samples for allogeneic unrelated recipients and donors. Additionally, allogeneic related recipients and donors will participate at select sites. The protocol also allows for submission of research samples from registered donors with rare tissue types.
- Protocol (PDF)
- Record of Revisions (PDF)
- IRB Approval
See Also: Donor Consent Forms, Recipient Consent Forms
These documents should be downloaded and submitted to your local IRB for review and approval. The NMDP/CIBMTR allows the consent forms to be formatted according to each site's requirements, but requires the protocols to be submitted as written. Upon obtaining local IRB approval, the NMDP IRB Office must receive a copy of the local IRB approval letter, approved protocol and informed consent documents. Send these documents to:
Becky Draxler, IRB Specialist
National Marrow Donor Program
3001 Broadway Street N.E, Suite 500
Minneapolis, MN 55413
E-mail: rdraxler@nmdp.org
Telephone: (612) 884-8469
Fax: (612) 627-5899
The NMDP IRB Office tracks the IRB approval for the Research Database and Research Repository protocols at each participating center. Sites will receive a renewal reminder approximately two months in advance of the local continuing review date. Local IRB approval for these protocols must be current at all times. Failure to have current local IRB approval may impact a center's ability to meet CPI requirements for data and sample submission.
We greatly appreciate your cooperation in ensuring that the NMDP/CIBMTR Research Program is compliant with all federal regulations. Please contact Roberta King, Director, NMDP Research Operations with questions or concerns about this process.
Telephone: (612) 627-5807
E-mail: rking@nmdp.org
Fax: (612) 627-5899
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