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Deceased Donor Intervention Research: a Survey of Transplant Surgeons, Organ Procurement Professionals, and Institutional Review Board Members

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Deceased Donor Intervention Research: a Survey of Transplant Surgeons, Organ Procurement Professionals, and Institutional Review Board Members American Journal of Transplantation 2015; XX: 1–9 C Copyright 2015 The American Society of Transplantation Wiley Periodicals Inc. and the American Society of Transplant Surgeons doi: 10.1111/ajt.13482 Deceased Donor Intervention Research: A Survey of Transplant Surgeons, Organ Procurement Professionals, and Institutional Review Board Members J. R. Rodrigue1,2,*, S. Feng3, A. C. Johansson2,4, A. K. Glazier5 and P. L. Abt6 Received 22 May 2015, revised 09 August 2015 and accepted for publication 10 August 2015 1Center for Transplant Outcomes and Quality Improvement, The Transplant Institute, Beth Israel Deaconess Medical Center, Boston, MA Introduction 2Harvard Medical School, Boston, MA 3Department of Surgery, University of California San The number of deceased donor organs has not kept pace Francisco, San Francisco, CA with the growing demand for transplantation in the United 4Department of Medicine, Beth Israel Deaconess States (1), despite many novel efforts to expand the organ Medical Center, Boston, MA supply (2–5). Innovative donor intervention strategies focus 5New England Organ Bank, Waltham, MA on achieving and maintaining optimal circulatory, metabolic, 6Department of Surgery, University of Pennsylvania, and hemodynamic function to facilitate procurement of Philadelphia, PA Ã organs for transplantation. Together with technological Corresponding author: James R. Rodrigue, advances to better preserve organs and mitigate organ [email protected] injury, identifying effective donor intervention strategies has potential to increase the number and quality of transplantable organs from deceased donors (6–10). For Innovative deceased donor intervention strategies instance, some studies have demonstrated that improve- have the potential to increase the number and quality ment in organ quality and more transplantable organs per of transplantable organs. Yet there is confusion donor can be achieved with more aggressive donor over regulatory and legal requirements, as well as intervention (9,11,12). While findings from donor interven- ethical considerations. We surveyed transplant sur- tion research are encouraging, there is considerable geons (n ¼ 294), organ procurement organization (OPO) professionals (n ¼ 83), and institutional review opportunity for growth in this line of scientific investigation. board (IRB) members (n ¼ 317) and found wide variations in their perceptions about research classi- The design and implementation of prospective, randomized fication, risk assessment for donors and organ controlled donor intervention trials is complex and neces- transplant recipients, regulatory oversight require- sitates collaborative agreements among investigators, ments, and informed consent in the context of organ procurement organizations (OPOs), and transplant deceased donor intervention research. For instance, centers to efficiently assess the impact of such interven- when presented with different research scenarios, tions on organ quality, the number of organs recovered and IRB members were more likely than transplant transplanted, and organ recipient outcomes. Additionally, surgeons and OPO professionals to feel that study the myriad regulatory, legal, and ethical issues pertaining to review and oversight were necessary by the IRBs at the investigator, donor, and transplant center hospi- deceased donor intervention research introduce daunting tals. Survey findings underscore the need to clarify conceptual and logistical challenges (10,13,14). Many ethical, legal, and regulatory requirements and their questions have been raised that warrant further clarification application to deceased donor intervention research and discussion in the donation, transplantation, and to accelerate the pace of scientific discovery and research oversight communities: Who can or should facilitate more transplants. authorize donor intervention research? Should transplant candidates be informed of donor research and, if so, how Abbreviations: IRB, institutional review board; OPO, and when should this occur? What are the risks to organ procurement organization; OPTN, Organ Pro- transplant recipients of organs from donors who were curement and Transplantation Network; PHI, personal part of interventional studies? What regulatory bodies, if health information; UNOS, United Network for Organ any, should review and provide oversight of deceased Sharing donor intervention research (14–16)? 1 Rodrigue et al Optimizing deceased donor organ quality and quantity as possible at these 100 centers via search of online directories. Next, we through innovative donor research necessitates that stake- identified the executive team members of the 58 OPOs in the United States holders—scientists, donation professionals, transplant using available online resources. professionals, governmental agencies, experts in human research protections, and the general public—reach Between May and October 2014, we emailed a study invitation to all ¼ ¼ consensus on these complex issues. However, the transplant surgeons (n 538), IRB members (n 1229), and OPO profes- sionals (n ¼ 138) for whom we found valid email addresses, providing a perceptions of these stakeholders regarding donor inter- secure hyperlink to complete the survey online. Because we were unable to vention research are unknown. Understanding these locate the email addresses of all OPO executive team members, we asked perceptions may be helpful in developing a pathway to those for whom we had valid email addresses to forward the study invitation perform donor intervention trials that provides balance to other team members. Reminder emails were sent 2 and 6 weeks later. among all stakeholders, but yet is within the current legal Beth Israel Deaconess Medical Center’s Committee on Clinical Inves- and ethical framework of organ donation and human tigations certified the exempt status of the study. research protection, and maintains public trust in organ donation processes. Therefore, we surveyed transplant Survey responses were exported into PASW 17.0 (IBM, Inc., Chicago, IL) for surgeons, OPO professionals, and institutional review coding and statistical analysis. Data are expressed as the number and board (IRB) members about deceased donor intervention percentage of respondents with specific item responses. Chi-square tests research. Each constituency may see donor research examined for differences between transplant surgeons, OPO professionals, and IRB members, as well as for response differences by sociodemographic through a different lens. OPO professionals are generally characteristics. If cell sizes did not meet requirements for chi-square tests, nonscientists with expertise in the donation process Fisher’s exact test was used. Due to the high number of statistical tests including authorization, donor management, and procure- performed, statistical significance was set at p < 0.01. ment, but without any training in human subjects research. The primary mission for OPO professionals is increasing the availability of transplantable organs. Transplant surgeons Results have scientific expertise, with some level of instruction on human subject research, and seek organs that yield the Survey response rate best possible outcomes for their patients. IRB members We sent 1905 email invitations, although the number of may lack knowledge about donation and transplantation, OPO professionals who received forwarded emails is but have considerable expertise about federal regulations unknown. Ninety-five emails (5%) were undeliverable. pertaining to human subjects research. Similarities and We received 732 responses, of which 694 usable surveys differences in their perspectives may help to shape future were collected. The difference (n ¼ 38) were submissions dialogue about deceased donor intervention research. that did not contain any responses. The response rate was higher for transplant surgeons (n ¼ 294, 55%) than for IRB members (n ¼ 317, 26%) (p < 0.001). Surveys were re- Methods ceived from 83 OPO professionals. When respondents (n ¼ 21) indicated more than one role (e.g. transplant We designed an online survey (Qualtrics, Provo, UT) to assess views about surgeon and IRB member), we selected a primary role conducting deceased donor intervention research. Questions were devel- using the following priority classification: transplant sur- oped to reflect the regulatory, legal, and ethical issues described in the geon first, OPO professional second, IRB member third. literature summarizing this line of research (10,13–15). The initial survey was reviewed by transplant surgeons (n ¼ 2), OPO professionals (n ¼ 2), IRB members (n ¼ 2), and a public health expert (n ¼ 1) and, based on their Respondent characteristics feedback, modifications were made to improve readability/clarity and to All 11 United Network for Organ Sharing (UNOS) regions reduce duplication. The final survey included three brief research scenarios, were represented. The majority of transplant surgeons each followed by questions with forced-choice responses assessing and OPO professionals but only half of IRB members had views about research classification, perceived risk, regulatory requirements, >5 years experience. Few (13%) transplant surgeons had and informed consent. An opportunity for open-ended comments was been directly involved in deceased donor intervention provided at the end of the survey. The three research scenarios were research. In contrast, most (71%) OPO professionals had selected because they each introduce unique ethical and regulatory participated
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