Q1-10: Consent Information

Question 1: Consent status for submitting research data to CIBMTR

!To be compliant with Federal Regulation for human research protection, centers must obtain IRB-approved informed consent from recipients and donors (if applicable, for the related donor sample repository) to allow data submitted to the CIBMTR to be used for observational research. Informed consent must also be obtained from the recipients and donors prior to submitting blood samples to the Research Sample Repository. The NMDP / CIBMTR has written protocol and informed consent documents for the Observational Database and Research Sample Repository. All centers must have local IRB approval for the Observational Database protocol. All centers that are NMDP member centers must also have local IRB approval for the Research Sample Repository protocol. With the exception of some selected sites (participating in the related sample repository), centers performing only related donor transplants and / or autologous transplants will not be submitting research samples and do not need to obtain local IRB approval for the repository protocol. The NMDP IRB has approved these protocol and consent forms, and the documents are provided to participating sites to include with their local IRB submissions.
International Centers must obtain consent of each patient participating in the Observational Database in a manner consistent with the laws and regulations of that country.
Under federal legislation, U.S. centers are required to submit outcomes data on all allogeneic transplants, related and unrelated. Data submitted without informed consent from the recipient should be reported on the TED Forms and will only be used for federally required research such as the center-specific outcomes analysis.

When a 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.

The primary purpose of the Observational Database is to have a comprehensive source of data that can be used to study hematopoietic cellular transplantation. Studies using these data include:

• How well recipients recover from their transplants
• How recovery after transplantation can be improved
• The long-term outcomes after transplantation
• How access to transplantation for different groups of recipients can be improved
• How well donors recover from collection procedures
• The application and success of transplantation in the management of marrow toxic injuries
  

Indicate if the recipient has signed an IRB-approved consent form to participate in the Observational Database. If Yes (provided permission and signed), continue with question 2. If No (declined, withdrew, or no response), continue with question 4. If Not approached, continue with question 5. If Reconsent Pending, continue with question 3.

*When to use the “Not approached” option for the Research Database Consent
CIBMTR expects all transplant centers to approach all patients for the Research Database consent. The Not approached option should only be used in the rare event when the physician feels it would be in the best interest of the patient not to be consented.

Note that if a center is required to approach a recipient for consent after the initial consent, the Not approached option will be disabled. If it is necessary that a subsequent consent be reported as Not approached please submit a ticket to CIBMTR center support, and CIBMTR staff will review the specific details for the recipient and ensure that the correct consent status is added to FormsNet3^SM if necessary.

Question 2: Consented to be contacted for future research

Indicate Yes (provided permission and signed), No (declined, withdrew, or no response), or Not approached (Institution not currently participating or local IRB does not allow collection of data), if the recipient has given permission to be directly contacted by the NMDP/CIBMTR for future research as documented on the research database consent form.

If Yes (provided permission and signed) is selected, the Recipient Contact Information (2820) form will also need to be completed.

Below is an example of this permission found in the NMDP/CIBMTR Research Database for Hematopoietic Cell Transplantation and Cellular Therapy Consent Form (Version 10.0).

*VIII. PERMISSION TO CONTACT FOR FUTURE CIBMTR RESEARCH STUDIES
Do you agree to give CIBMTR permission to contact you in the future to tell you about research studies for which you are eligible? These studies are different from the studies that use your medical data. These studies would involve you directly, for example, asking you to complete a survey. You may decide if you want to participate in a specific study when you are contacted. By checking the “AGREE” box below, you are only agreeing that CIBMTR can contact you to tell you about the study.
Due to the need to follow up with you after your transplant, please tell your transplant center if your contact information changes. If the contact information on file is no longer valid, it might be necessary to use an internet-based search service to find you. By agreeing to be contacted for future studies, you authorize CIBMTR to use such a service to search public and non-public information only for the purpose of trying to locate you. ☐ I AGREE to allow CIBMTR to contact me about future studies. ☐ I DO NOT want CIBMTR to contact me about future studies.

Question 3: Date consent signed

Report the date the CIBMTR research database consent form was signed by the recipient. Do not report the date that the witness or health care professional signed the consent form.

Question 4: Date approached

If No (declined, withdrew, or no response), was reported in question 1, report the date the recipient was originally approached with the CIBMTR research database consent form.

Question 5: Reason not approached

If Not approached, was reported in question 1, report the reason and/or details as to why the recipient could not be approached with the CIBMTR research database consent form. Choose from the options in the drop-down box:

• Consent form pending IRB approval / renewal: At the time of consent for the Research Database, a valid consent form is not available at the center.
• Consent form unavailable in patient’s language: At the time of consent for the Research Database, a consent form / short form is not available in the recipient’s language and an interpreter was not available.
• Patient died before consent obtained: The recipient passed away prior to consenting to the Research Database.
• Patient incarcerated: At the time of consent for the Research Database, the recipient is incarcerated.
• Patient too ill: At the time of consent for the Research Database, the recipient is too ill to consent.
• Other reason: Select this option if the recipient is not approached for the Research Database for any other reason not listed above.

!It has been determined that a recipient lacking mental capacity to consent to the Research Database is not considered a valid option. Adult recipients with diminished capacity should have an assigned representative who works with the recipient on the consent process. CIBMTR will query the Other reason option if the reason is reported as ‘lacking mental capacity’ in the the specify other reason data field.

Question 6-7: Indicate language preference

If consent form unavailable in patient’s language was reported in question 5, select the recipient’s language preference from the drop-down menu. If the language is not present in the list, select ‘other’ and then specify other language preference in question 7.

Question 8: Specify other reason not approached

If Not approached was reported in question 1 and other reason was reported in question 5, report the other reason not approached.

Question 9-10: Reason consent status changed

If a change is made to the consent status in an existing consent row or an additional consent row is added, report the reason that the consent status changed in question 9. If the reason for changing consent is not listed, select Other, and specify the reason in question 10.

Question 9 will always be required when editing a consent row or adding subsequent consent after the initial consent.

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CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.