Skip Navigation LinksHome   |   Data Management   |   Protocols and Consent Forms   |   Observational Database
  • Print
  • Share

Observational Database Protocol and Consent Forms

When a donor or recipient consents to participate in the Observational Database, their data are contained in the CIBMTR’s Observational Database and used for research. The database includes recipient baseline and outcome data for related and unrelated allogeneic transplants from any cell source, and for autologous transplants. Data are also collected on unrelated donors and their donation experiences.

Research goals

The primary purpose of the Observational Database is to have a comprehensive source of data that can be used to study hematopoietic cell transplantation (HCT).

These data may be used in research to:

  • Determine and evaluate factors that affect HCT outcomes
  • Improve recipient recovery from transplant
  • Assess long-term outcomes after HCT
  • Determine how to improve access to HCT for different groups of patients
  • Assess donor recovery from collection procedures
  • Study the application and success of HCT in the management of marrow-toxic injuries

Return to top

Recipient and donor participation

Any recipient of an unrelated or related donor or autologous transplant in a CIBMTR-affiliated center may participate in the Observational Database. All volunteer donors registered on the National Marrow Donor Program’s Be The Match Registry® who have been requested to donate marrow or peripheral blood stem cells for a recipient may also participate. Complete eligibility requirements are outlined in the study protocol.

If the recipient of an allogeneic (related or unrelated) HCT does not consent to the use of his/her data for research, the transplant center will still be required to submit TED – level data on the recipient. In this case, the recipient’s data will only be used for federally required analyses, such as the center-specific analysis mandated by CIBMTR’s contract to operate the Stem Cell Therapeutic Outcomes Database (SCTOD). The recipient’s data will never be included in research studies.

TED-level data is used in research.  Therefore, if a transplant center only submits TED-level data to CIBMTR, the center must still approach all allogeneic HCT recipients for consent to the Observational Database.  If a recipient consents to the Observational Database, his/her TED-level data will be used in research.

For autologous recipients who do not consent to participate in research, CIBMTR requests that the following minimal data be submitted: year of birth, diagnosis, transplant type and date of transplant. This information will help ensure that the epidemiological integrity of the database is maintained, and does not require provision of any significant health information that could identify the recipient, nor will this information be used in any analysis.

Return to top

IRB requirements

U.S. transplant centers

To be compliant with United States Federal Regulations for human research subject protection, all transplant centers must obtain IRB-approved informed consent from recipients to allow data submitted to the Observational Database to be used for research studies, regardless of the level of data the center submits to CIBMTR. All U.S. transplant centers must have local IRB approval for the Observational Database Research protocol.

Upon obtaining local IRB approval, the NMDP IRB must receive a copy of the local IRB’s approval letter, approved protocol and informed consent documents. These documents should be sent to:

Christina Jobe, Program Specialist
National Marrow Donor Program
3001 Broadway Street N.E, Suite 110
Minneapolis, MN 55413
E-mail: cjobe@nmdp.org
Telephone: (612) 627-8164
Fax: (612) 627-5899

The NMDP IRB tracks the IRB approval for the Observational Database at each participating center. Centers will receive a renewal reminder approximately two months in advance of their local continuing review date. Local IRB approval for this protocol must be current at all times. Failure to have current local IRB approval may affect a center’s ability to meet CPI requirements for data submission.

International transplant centers

International transplant centers must follow their country’s laws and regulations governing human subjects and privacy protection. The transplant center is responsible for obtaining the necessary institutional review and approval for the Observational Database.

If the recipient does not consent to participate in the Observational Database according to the laws and regulations of their country, CIBMTR requests that the following minimal data be submitted: year of birth, diagnosis, transplant type and date of transplant. This information will help ensure that the epidemiological integrity of the database is maintained, and does not require provision of any significant health information that could identify the recipient, nor will this information be used in any analysis. This applies to recipients of allogeneic (related and unrelated) and autologous HCT.

Return to top

CIBMTR approved protocol and consent forms

CIBMTR, through the NMDP IRB, has approved the following protocol and consent forms. Your center must submit these documents to your local IRB for review and approval. CIBMTR and NMDP allow the consent forms to be formatted according to each site’s requirements, but requires the protocols to be submitted as written.

Database protocol

Database IRB approvals

Database recipient consent forms

Allogeneic transplants

Autologous transplants

Marrow toxic injury

Database donor consent forms

Adult allogeneic unrelated donor consent form

The donor consent form has been submitted for translation.  In the meantime, U.S. federal regulations allow for the use of a Short Form when a fully translated consent form is not available.  If you need the Short Form, please contact IRBStaff@nmdp.org.

 

 

Return to top


To view PDF documents you will need Adobe Reader.
Get Adobe Reader


Last Updated: 7/30/2014 7:54 AM