Informed consent in research to improve the number and quality of deceased donor organs
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Updated: Jun 7, 2026
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Published on: March 15, 2024
Michael M Rey1, Lorraine B Ware, Michael A Matthay
1University of Pennsylvania School of Medicine, Philadelphia, PA, USA.
Abstract:
Improving the management of potential organ donors in the intensive care unit could meet an important public health goal by increasing the number and quality of transplantable organs. However, randomized clinical trials are needed to quantify the extent to which specific interventions might enhance organ recovery and outcomes among transplant recipients. Among several barriers to conducting such studies are the absence of guidelines for obtaining informed consent for such studies and the fact that deceased organ donors are not covered by extant federal regulations governing oversight of research with human subjects. This article explores the underexamined ethical issues that arise in the context of donor management studies and provides ethical guidelines and suggested regulatory oversight mechanisms to enable such studies to be conducted ethically. We conclude that both the respect that is traditionally accorded to the prior wishes of the dead and the possibility of postmortem harm support a role for surrogate consent of donors in such randomized controlled trials. Furthermore, although recipients will often be considered human subjects under federal regulations, several ethical arguments support waiving requirements for recipient consent in donor management randomized controlled trials. Finally, we suggest that new regulatory mechanisms, perhaps linked to existing regional and national organ donation and transplantation infrastructures, must be established to protect patients in donor management studies while limiting unnecessary barriers to the conduct of this important research.
Insights
Improving organ donor management in ICUs requires ethical guidelines for research. This study proposes surrogate consent for donors and waiving consent for recipients to enable crucial clinical trials for better organ transplantation outcomes.
Area of Science:
- Medical Ethics
- Intensive Care Medicine
- Organ Transplantation Research
Background:
- Enhancing organ donor management in intensive care units (ICUs) is vital for increasing organ availability and quality for transplantation.
- Conducting randomized clinical trials (RCTs) is essential to evaluate interventions for improving organ recovery and recipient outcomes.
- Significant ethical and regulatory barriers hinder research in this area, including informed consent and oversight for deceased donors.
Purpose of the Study:
- To explore underexamined ethical issues in donor management studies.
- To provide ethical guidelines and regulatory mechanisms for conducting ethical research in organ donor management.
- To facilitate crucial RCTs that can improve organ transplantation.
Main Methods:
- Ethical analysis of informed consent for deceased organ donors and living recipients in RCTs.
- Review of existing federal regulations regarding human subject research.
- Development of proposed ethical guidelines and regulatory oversight models.
Main Results:
- Respect for prior wishes and potential for postmortem harm support surrogate consent for donors in RCTs.
- Ethical arguments support waiving recipient consent requirements in donor management RCTs.
- Existing regulatory frameworks are insufficient for protecting participants and facilitating research.
Conclusions:
- Surrogate consent for organ donors and potential waiver of consent for recipients are ethically justifiable in specific research contexts.
- New regulatory mechanisms, integrated with organ donation infrastructures, are needed.
- Ethical frameworks and regulatory adaptations are crucial for advancing organ donor management research and improving transplantation success.
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