Question 1: Consent status for submitting research data to CIBMTR
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.
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 FormsNet3SM 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).
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.
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.