Deceased Donor Intervention Research: A Survey of Transplant Surgeons, Organ Procurement Professionals, and Institutional Review Board Members.
Innovative deceased donor intervention strategies have the potential to increase the number and quality of transplantable organs. Yet there is confusion over regulatory and legal requirements, as well as ethical considerations. We surveyed transplant surgeons (n = 294), organ procurement organization (OPO) professionals (n = 83), and institutional review board (IRB) members (n = 317) and found wide variations in their perceptions about research classification, risk assessment for donors and organ transplant recipients, regulatory oversight requirements, and informed consent in the context of deceased donor intervention research. For instance, when presented with different research scenarios, IRB members were more likely than transplant surgeons and OPO professionals to feel that study review and oversight were necessary by the IRBs at the investigator, donor, and transplant center hospitals. Survey findings underscore the need to clarify ethical, legal, and regulatory requirements and their application to deceased donor intervention research to accelerate the pace of scientific discovery and facilitate more transplants.
Center for Transplant Outcomes and Quality Improvement, The Transplant Institute, Beth Israel Deaconess Medical Center, Boston, MA.|Harvard Medical School, Boston, MA.
J R
JR
Rodrigue
Department of Surgery, University of California San Francisco, San Francisco, CA.
S
S
Feng
Harvard Medical School, Boston, MA.|Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA.
A C
AC
Johansson
New England Organ Bank, Waltham, MA.
A K
AK
Glazier
Department of Surgery, University of Pennsylvania, Philadelphia, PA.
P L
PL
Abt
D035843:Biomedical Research / Q000941:ethics*; D002102:Cadaver; D028744:Ethics Committees, Research; D006801:Humans; D016377:Organ Transplantation / Q000941:ethics* / Q000331:legislation & jurisprudence; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D066231:Surgeons; D011795:Surveys and Questionnaires; D014019:Tissue Donors / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000600:supply & distribution*; D009927:Tissue and Organ Procurement / Q000941:ethics / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D017749:Total Quality Management
donors and donation; donors and donation: deceased; ethics; ethics and public policy; organ procurement and allocation; organ procurement organization; social sciences; survey