United States Transplant Centers – Institutional Review Board (IRB) Approval
To be compliant with United States Federal Regulations for human research subject protection, transplant centers must obtain IRB-approved informed consent from recipients to allow data submitted to the Observational Database to be used for research studies. All transplant centers must have IRB approval for the Observational Database Research protocol. This includes all transplant centers participating as Transplant Essential Data (TED) only and Comprehensive Report Form (CRF) centers. All transplant centers that are NMDP member centers must also have IRB approval for the Biorepository protocol for unrelated recipients.
- The transplant centers participating in the Related Transplant Research Repository will submit research samples on related recipients and their donors in addition to the samples on unrelated donor recipients.
- Transplant centers that perform related donor HCTs and do not participate in the Related Transplant Research Repository will not submit research samples, and therefore do not need to obtain local IRB approval for the repository protocol.
NMDP and CIBMTR have written protocols and informed consent documents for the Observational Database and Biorepository. The current versions of the protocols and consent documents should be downloaded from the CIBMTR website. Prior to obtaining IRB approval for these consent documents, all centers must work with the CIBMTR study team(s) to review any revisions to the study consent documents. Participating centers may rely on their local IRB or the NMDP IRB. For any sites obtaining initial approval on the studies after January 20, 2020 reliance on the NMDP IRB through Single IRB is required. Upon obtaining IRB approval, the CIBMTR study team(s) must receive a copy of the IRB’s approval letter, approved protocol and informed consent documents. The CIBMTR study team(s) tracks the IRB approval for the Observational Database and Biorepository protocols at each participating center. Sites will receive a renewal reminder approximately two months in advance of the local continuing review date. CIBMTR clinical research coordinators (CRCs) also send notice of the IRB expiration date to the primary data manager with the center’s monthly CPI reports. Local IRB approval for these protocols must be current at all times. Failure to have current local IRB approval can impact a center’s ability to meet CPI requirements for data and sample submission.
CIBMTR Study teams can be reached DatabaseIRB@nmdp.org and RepositoryIRB@nmdp.org
If an allogeneic recipient does not consent to participate in the Observational Database, the transplant center will still be required to submit TED-level data on the recipient. CIBMTR will not use the recipient’s data for research studies. However, the data provided on the TED forms will be used for evaluation of the C.W. Bill Young Cell Transplantation Program, and federally required analyses such as center volumes and center-specific analysis This is mandated by CIBMTR’s contract to operate the Stem Cell Therapeutic Outcomes Database (SCTOD). This applies to recipients of allogeneic (related and unrelated) HCTs. For autologous recipients who do not consent to participate in research, CIBMTR requests the completion of the CRID Assignment Form 2804, the Indication for CIBMTR Data Reporting Form 2814, the Pre-Transplant Essential Data Form 2400, and the Pre-TED Disease Classification Form 2402, each indicating consent to research as ‘no’. This reporting will help ensure the epidemiological integrity of the database and that the recipient’s information will not be used in research.