When a recipient consents to participate in research, their data are contained in the CIBMTR’s Observational Database. The database includes recipient baseline and outcome data for related and unrelated allogeneic transplants or other cellular therapy from any cell source, and for autologous transplants or other cellular therapy. Data are also collected on unrelated donors and their donation experiences.
The primary purpose of the Observational Database is to have a comprehensive source of data that can be used to study hematopoietic cell transplantation.
Studies in which these data may be used include:
- How well recipients recover from their transplants or cellular therapy
- How recovery after transplantation or cellular therapy can be improved
- Long-term outcomes after transplantation or cellular therapy
- How access to transplantation or cellular therapy for different groups of recipients can be improved, including studies designed to inform insurance/payer policy, such as U.S. Medicare policy
- How well donors recover from collection procedures
- The application and success of transplantation in the management of marrow-toxic injuries
Consenting Requirements for Participants Enrolling onto the CMS CED Sub-Studies
There are 2 consent forms that all CMS CED Sub-Study Participants are eligible to sign: the main Research Outcomes Database Recipient consent form and the CMS Sub-Study consent form. For participants to receive CMS coverage for their transplant, . Participants may choose to also sign the main Research Outcomes Database Recipient consent form.
If a CMS Sub-study Participant was only presented the Research Outcomes Database recipient consent form the following steps should be followed:
1. Approach identified patients that were not offered the opportunity to sign the CMS specific consent for CED participation:
- a. Offer these patients both the CMS Sub-study consent and the Main Research Database Consent form
- b. You site should explain to participant that they originally had consented to sharing their data with the observational database, but they should have had the option to share data solely for the purposes of the CMS CED sub studies.
2. Participant will accept or decline consent(s).
- a. If participant signs only the CMS sub study consent, this will reflect the participant’s decision to use data solely for CMS CED sub study and indicates the participant does not want to be included in the Observational Research Database Protocol. This will be entered in FN3 as a withdrawal from RDB Consent.
- b. If participants sign both the CMS sub study consent AND the Research Database Recipient consent, then the participant’s data may continue to be used in the larger observational database protocol.
3. Site will retain both the original and new consent documents.
4. Site will submit a Reportable Event to their IRB of record and provide a CAPA to avoid not offering the CMS consent to future patients.
5. For additional questions reach out to DatabaseIRB@nmdp.org