*Purpose: A Manufactured Organ Research Facility (MORF) was created at our institution to provide a safe environment for testing xenograft organs in deceased brain dead humans (DBDs) as an intermediary step in advancing xenotransplantation to living human clinical trials. A key component of the MORF framework is organ procurement organization (OPO) collaboration.

*Methods: Research involving DBDs has been limited and falls outside of standard regulations. We collaborated with our local OPO to create a successful model to identify eligible DBDs, approach family members of the DBD, and obtain informed authorization for the DBD to enroll in the MORF study. Through planning, education, and simulation practice, the following authorization process was implemented: 1. Upon referral for potential organ or tissue donation, the OPO makes determination of the DBD’s medical candidacy for organ donation. If ruled out for organ donation, the Authorized Party (AP) is approached by the OPO to assess interest in a research study. 2. If the AP is interested, the OPO presents introductory language about the research, and the standard OPO authorization for organ donation and research is obtained. The OPO then facilitates an introduction of the Primary Investigator (PI) to the AP by phone. 3. The PI explains the specifics of the research project. If the AP decides to proceed, the Institution study team (ST) reviews the detailed Research Project Authorization Form, which contains: Authorization for Medical Research, Authorization for use of body, and Consent for Transfer. 4. The AP has an opportunity to ask questions throughout the process and makes the decision of whether or not to authorize the DBD to participate in the MORF research. 5. Authorization is documented by signature on a paper form, electronically in a RedCap database, or by recorded phone line if an electronic platform is not available to the AP. The OPO and the ST confirm by signature as well. Timing and training for an effective approach is rehearsed (role-playing), scripted, and includes a pre-huddle to understand family dynamics and background to personalize the approach. Special consideration is given to appropriate nomenclature and description of the procedure to balance science and the sensitive timing of the information.

*Results: Of 22 DBD’s approached between 11/2/20 and 10/31/21, 3 were enrolled in the MORF study.

*Conclusions: We demonstrated successful collaboration with our local OPO to establish a process for authorizing DBD subjects in MORF xenotransplantation studies.

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