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 local IRB approval for the Observational Database Research protocol. This includes all transplant centers participating as TED only and Comprehensive Report Form centers. All transplant centers that are NMDP member centers must also have local IRB approval for the Research Sample Repository 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.
The NMDP and CIBMTR have written protocols and informed consent documents for the Observational Database and Research Sample Repository. The protocols and consent documents should be downloaded from the CIBMTR website and submitted to the transplant center’s local IRB for review and approval. The protocols and consent forms must be submitted to the local IRB as written by the NMDP and CIBMTR; however, the documents may be formatted according to each site’s requirements. The Observational Database and Research Sample Repository protocols and consent forms can be obtained from the CIBMTR website – click here.
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. The NMDP IRB Office tracks the IRB approval for the Observational 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. The 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.
If the 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. The 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 analysis such as center volumes and center-specific analysis, mandated by CIBMTR’s contract to operate the Stem Cell Therapeutic Outcomes Database (SCTOD). This applies to recipients of allogeneic (related and unrelated) HCT. For autologous recipients who do not consent to participate in research, the CIBMTR requests the completion of CRID Assignment Form 2804, the Indication for CRID Assignment 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 that the epidemiological integrity of the database is maintained, and the recipient’s information will not be used in research.
Submit IRB approval documents to the CIBMTR Research Administration designee. For contact information, contact your CIBMTR CRC.