The CIBMTR works with the NMDP/Be The Match maintained comprehensive Human Research Protection Program (HRPP) to ensure that the rights and welfare of participants in its research are protected and to ensure compliance with all pertinent US federal regulations. In December 2014, the NMDP/Be The Match HRPP was fully accredited by the Association for the
Accreditation of Human Research Protection Programs (AAHRP).
Since 2011, under an IRB Authorization Agreement between the Medical College of Wisconsin and the National Marrow Donor Program (NMDP)/Be The Match, the NMDP IRB serves as the IRB of record for all research conducted by the CIBMTR. The NMDP IRB has the authority to approve, require modifications in, or disapprove all research activities within its jurisdiction as specified by both federal and state regulations and NMDP/Be The Match policies and
procedures. Although the NMDP IRB also reviews protocols from individual transplant centers where the NMDP/Be The Match unrelated donor is considered a research subject by virtue of the research their recipient is participating in, only CIBMTR sponsored research is addressed in this chapter. As part of the CIBMTR human subject protection program, all CIBMTR staff members are required to complete initial and continuing education and training in the protection of human subjects through the Collaborative Institutional Training Initiative (www.citiprogram.org).
12.1 PROGRAM OVERSIGHT AND STAFF
Day-to-day operational activities of the NMDP IRB are overseen by an IRB Administrator, two Sr. Human Research Protection Specialists, Human Research Program Specialist, and
Administration Specialist, as shown in Figure 12.1.
Figure 12.1: NMDP IRB Organizational Structure
NMDP/Be The Match Chief Executive Officer Institutional Official
IRB Administrator
Sr. HRPP Specialists (2) HRPP Specialist Administrative Specialist
These are the Office of Human Research Protection (OHRP) common rule regulations (45 CFR Part 46) and the
CIBMTR Manual of Operations Chapter 12: HRPP
Members of the NMDP IRB are appointed based on their capacity to participate fully in the NMDP IRB process and are qualified through education and experience to assure a
comprehensive review of the research. There are nine primary members of the NMDP IRB, including three stem cell physicians, a blood bank physician, two ethicists, a donor advocate, an epidemiologist, and a cord blood donor. There are no term limits for NMDP IRB members.
12.2 KEY ACTIVITIES
The NMDP IRB reviews all human subject research involving CIBMTR staff. The CIBMTR research activity subject to this oversight includes all research efforts within its major Programs which are described in detail in Chapters 6 through 9. These include:
Observational Studies (projects implemented within the structure of its Working Committees);
Immunobiology Research Program;
Clinical Trials Support (i.e., RCI BMT specifically, including all Survey Research projects or in BMT CTN studies involving unrelated donors as research subjects;
HSR Program;
Observational studies implemented through the Scientific Working Committee Structure that utilize data from the Research Database or specimens from the Repository are conducted under the Research Database protocol (http://www.cibmtr.org/DataManagement/ProtocolConsent/) and / or Research Sample Repository protocol (http://www.cibmtr.org/DataManagement/ ProtocolConsent/ResearchSamples/pages/index.aspx). All CIBMTR transplant centers and NMDP/Be The Match donor centers are required to maintain local IRB approval for the
Database and Repository protocols and seek consent from patients and donors for use of their data or samples in CIBMTR research. Clinical outcomes studies approved by a Scientific Working Committee are submitted by CIBMTR Coordinating Center staff to the NMDP IRB for
administrative approval under one or both of these two protocols. PIs of observational studies do not need to submit the observational study to their own local IRB for review and approval. Studies conducted through CIBMTR’s RCI BMT or HSR Programs are also subject to oversight by the NMDP IRB. Protocols conducted through these Programs must be approved by the NMDP IRB prior to implementation. Once the NMDP IRB has approved the study, it is released to participating sites for approval by their local IRBs. PIs of these studies seek approval from their local IRB at the same time as the participating sites.
12.2.1 Monitoring Center IRB Compliance
As noted above, to be compliant with US federal regulations for human research subject protection, all transplant centers and donor centers participating in a CIBMTR sponsored
research protocol must obtain local IRB approval for the study. The local IRB approval letter and approved consent forms for the Research Database and Research Sample Repository protocols must be submitted to the NMDP IRB Office. Local IRB approval letters and consent forms for all other CIBMTR sponsored research must be submitted to the CIBMTR staff designated for the specific study.
Depending on the protocol, the NMDP IRB Office or designated CIBMTR staff track the IRB approval at each participating center. Sites receive a renewal reminder approximately two
months in advance of the local continuing review date. Local IRB approval for CIBMTR protocols must be current for continued participation in the protocol.
12.2.2 Investigator Support for Completing NMDP IRB Application
CIBMTR staff members involved in RCI BMT or HSR assist PIs of CIBMTR sponsored research in completing the NMDP IRB initial and continuing review applications. In addition, IRB staff members assist in the NMDP IRB application process by reviewing all submissions prior to NMDP IRB review to ensure the application is complete. Investigators with current NMDP IRB- approved studies are sent the NMDP IRB continuing review application approximately two months prior to the scheduled continuing review of the study.
CIBMTR Manual of Operations Chapter 13: Data – Access and Release