Donors as Research Subjects
These resources will help you understand when a donor is considered a research subject and how to initiate NMDP Institutional Review Board (IRB) review.
- Algorithm Analysis (DOC)
This algorithm can help you determine if an unrelated donor is a human research subject on a recipient research protocol, or is not a human research subject but is supporting research activities on a recipient research protocol.
- Transplant Center Procedures (PDF)
This procedure provides step-by-step instructions for testing transplant center research protocols against the Algorithm Analysis Worksheet (see above).
- Transplant Center IRB Memo (PDF)
This memo can be submitted to your local IRB along with the Algorithm Analysis Worksheet for recipient research protocols that involve unrelated donors.
- Donors as Research Subjects FAQs (PDF)
This document addresses frequently asked questions about donors as research subjects.
The Determining if Donors are Research Subjects training program is for transplant center staff who are responsible for submitting unrelated hematopoietic cell transplant research protocols to their local IRBs. The training program can be found in an online catalog through the NMDP/Be The Match Learning Center.
Please log in to the NMDP/Be The Match Learning Center.
- Returning users: Log on to the Learning Center
- New users: Create an account in the Learning Center using the link on page 1 of the User Guide for Network Members (PDF).
- NMDP/Be The Match Employees: Access the Learning Center.
This session will teach transplant center staff how to use an algorithm to help determine if recipient research protocols include activities that qualify the unrelated donor as a research subject.
After completing this lesson, participants will be able to:
- Discuss the basis for the algorithm
- Identify donor data that can be used on a research protocol without the need for NMDP IRB approval
- Use our algorithm to determine whether or not an unrelated donor is a human research subject
- Describe actions to take if a donor is determined to be a human research subject
- Review the process for requesting unrelated donors on research studies
After completing the training, you will be directed to an evaluation and brief post-assessment. If you score below 100%, please review the content and retake the assessment. Upon passing, print the report and keep it with your training records.