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Deceased Donor Intervention Research: A Survey of Transplant Surgeons, Organ Procurement Professionals, and
J R Rodrigue1,2, S Feng3, A C Johansson2,4
1Center for Transplant Outcomes and Quality Improvement, The Transplant Institute, Beth Israel Deaconess Medical Center, Boston, MA.
Abstract:
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.
Insights
Innovative strategies to improve deceased donor organs face regulatory and ethical confusion. Clarifying these requirements is crucial for advancing transplant research and increasing organ availability.
Area of Science:
- Transplantation research
- Organ procurement
- Medical ethics
Background:
- Deceased donor intervention strategies aim to enhance organ availability and quality for transplantation.
- Current practices face significant confusion regarding regulatory, legal, and ethical considerations.
Purpose of the Study:
- To investigate perceptions of regulatory, legal, and ethical requirements for deceased donor intervention research.
- To identify variations in understanding among key stakeholders involved in organ transplantation.
Main Methods:
- A survey was conducted among transplant surgeons (n=294), organ procurement organization (OPO) professionals (n=83), and institutional review board (IRB) members (n=317).
- Participants responded to scenarios assessing views on research classification, risk assessment, regulatory oversight, and informed consent.
Main Results:
- Significant variations were found in perceptions regarding research classification, risk assessment, and informed consent.
- IRB members were more inclined than surgeons and OPO professionals to mandate IRB review at multiple hospital levels.
Conclusions:
- There is a critical need to clarify ethical, legal, and regulatory frameworks for deceased donor intervention research.
- Standardized guidelines are essential to accelerate scientific discovery and increase organ transplantation rates.
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