Challenges encountered in conducting donor-based research: Lessons learned from the Donor Heart Study

Kiran K. Khush, Helen Luikart, Nikole Neidlinger, Ahmad Salehi, John Nguyen, P. J. Geraghty, John Belcher, Bruce Nicely, Martin Jendrisak, Thomas Pearson, R. Patrick Wood, Tahnee Groat, Brian Wayda, Jonathan G. Zaroff, Darren Malinoski

    Research output: Contribution to journalComment/debatepeer-review

    Abstract

    Solid organ transplantation continues to be constrained by a lack of suitable donor organs. Advances in donor management and evaluation are needed to address this shortage, but the performance of research studies in deceased donors is fraught with challenges. Here we discuss several of the major obstacles we faced in the conduct of the Donor Heart Study—a prospective, multi-site, observational study of donor management, evaluation, and acceptance for heart transplantation. These included recruitment and engagement of participating organ procurement organizations, ambiguities related to study oversight, obtaining authorization for donor research, logistical challenges encountered during donor management, sustaining study momentum, and challenges related to study data management. By highlighting these obstacles encountered, as well as the solutions implemented, we hope to stimulate further discussion and actions that will facilitate the design and execution of future donor research studies.

    Original languageEnglish (US)
    JournalAmerican Journal of Transplantation
    DOIs
    StateAccepted/In press - 2022

    Keywords

    • clinical research/practice
    • donor evaluation
    • donors and donation
    • editorial/personal viewpoint
    • ethics
    • heart transplantation/cardiology
    • organ procurement and allocation

    ASJC Scopus subject areas

    • Immunology and Allergy
    • Transplantation
    • Pharmacology (medical)

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