Research Consent Models Used in Prospective Studies of Neurologically Deceased Organ Donors: A Systematic Review

D’Aragon, Frédérick; Burns, Karen E. A.; Yaworski, Amanda; Lucas, Amanda; Arseneau, Erika; Belley‐Côté, Emilie P.; Dhanani, Sonny; Frenette, Anne-Julie; Lamontagne, François; Lauzier, François; Akhtar, Aemal; Oczkowski, Simon; Rochwerg, Bram; Meade, Maureen O.

doi:10.1177/1556264620904627

Cited by 5 publications

(8 citation statements)

References 27 publications

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“…A recent systematic review by D’Aragon et al discussed variability in practice relating to research consent models used in prospective studies in neurologically deceased organ donors. Due to this variability, they stress the need for clarity related to ethical standards as well as the need for further research into consent procedures, specifically into privacy laws, research governance, and cultural norms in organ donation (D’Aragon et al, 2020).…”

Section: Discussionmentioning

confidence: 99%

Transplant Recipient Preferences Regarding Organ Donor Research: Their Role in Consent and use of Their Data

Lucas

Strachan

D’Aragon

et al. 2023

Journal of Empirical Research on Human Research Ethics

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Research on deceased organ donors has been hindered by concerns related to seeking research consent from transplant recipients. We undertook this qualitative study to elucidate solid organ transplant recipients views on organ donor research, their role in the consent for such research, and their preferences related to providing their data. We conducted interviews with 18 participants and three themes emerged from the data. The first centered around participant research literacy. The second described practical preferences of participating in research, and the third related to the connection between donor and recipient. We concluded that previously held views about the requirement for transplant recipients to have a consenting role in donor research is not always suitable.

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Section: Discussionmentioning

confidence: 99%

Transplant Recipient Preferences Regarding Organ Donor Research: Their Role in Consent and use of Their Data

Lucas

Strachan

D’Aragon

et al. 2023

Journal of Empirical Research on Human Research Ethics

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“…Despite this recommendation, recent trends suggest that many deceased donor intervention studies are increasingly employing waived consent models, which waive the requirement for informed consent. 42 The most frequent justification for waived consent is that deceased donors are not research participants, and therefore, informed research consent is not required. 42 Although this may be true, it is nonetheless advisable to obtain first-person or surrogate consent for research to maintain public trust and demonstrate respect for the decisional autonomy of the previously living person and their surrogates.…”

Section: Consent and Ethical Frameworkmentioning

confidence: 99%

Research and Innovation in Organ Donation: Recommendations From an International Consensus Forum

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Issa

Cayouette

et al. 2023

Transplantation Direct

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Background. This report provides recommendations from the Research and Innovation domain as part of the International Donation and Transplantation Legislative and Policy Forum (hereafter the Forum) to provide expert guidance on the structure of an ideal organ and tissue donation and transplantation system. The recommendations focus on deceased donation research and are intended for clinicians, investigators, decision-makers, and patient, family, and donor (PFD) partners involved in the field. Methods. We identified topics impacting donation research through consensus using nominal group technique. Members performed narrative reviews and synthesized current knowledge on each topic, which included academic articles, policy documents, and gray literature. Using the nominal group technique, committee members discussed significant findings, which provided evidence for our recommendations. The Forum’s scientific committee then vetted recommendations. Results. We developed 16 recommendations in 3 key areas to provide stakeholders guidance in developing a robust deceased donor research framework. These include PFD and public involvement in research; donor, surrogate, and recipient consent within a research ethics framework; and data management. We highlight the importance of PFD and public partner involvement in research, we define the minimum ethical requirements for the protection of donors and recipients of both target and nontarget organ recipients, and we recommend the creation of a centrally administered donor research oversight committee, a single specialist institutional review board, and a research oversight body to facilitate coordination and ethical oversight of organ donor intervention research. Conclusions. Our recommendations provide a roadmap for developing and implementing an ethical deceased donation research framework that continually builds public trust. Although these recommendations can be applied to jurisdictions developing or reforming their organ and tissue donation and transplantation system, stakeholders are encouraged to collaborate and respond to their specific jurisdictional needs related to organ and tissue shortages.

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“…In some countries, only living persons are considered potential research participants, for example, in the USA [22]. While there is often an implicit or explicit assumption in donor intervention studies, for example, that formal human research ethics committee (HREC) review is not needed for the deceased, other studies recognize the need for HREC review and designate deceased donors as participants [5,23].…”

Section: Determining the Ethical Status Of Individuals Who May Be Involved In Researchmentioning

confidence: 99%

“…Despite clinical experience with these ethical aspects, researchers may also have difficulty engaging with them from the research perspective. Confusion regarding the ethical considerations of RDDT is evident in the uncertainty demonstrated by HRECs and researchers regarding the ethical status of individuals involved in research [5,26]. Such confusion risks undermining public confidence and trust not only in the research but also in donation and transplantation activities more broadly.…”

Section: Ethical Guidance Is Needed To Address Barriers To Rdttmentioning

confidence: 99%

“…New ethical challenges have also arisen with the expansion of organ donation following determination of death using circulatory criteria and the emergence of novel techniques and therapies for use in organ repair and replacement. Several authors have observed that ethical considerations and related logistical and regulatory factors may present potential barriers to clinically oriented, innovative research in donation and transplantation [2–5]. The success of continued work to increase the availability of organs for transplantation and to improve outcomes for transplant recipients depends on the ethical conduct of research in this field and on efforts to address ethical considerations that may pose a barrier to the research itself [6].…”

Section: Introductionmentioning

confidence: 99%

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Addressing ethical confusion in deceased donation and transplantation research: the need for dedicated guidance

Martin

Cronin

Ave

et al. 2021

Transplant International

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Summary Innovative research in deceased donation and transplantation often presents ethical challenges for researchers and those responsible for ethical governance of research. These challenges have been recognized as potential barriers to the conduct of research. We review the literature to identify and describe ethical considerations that may cause confusion or uncertainty in the context of research involving potential deceased donors or deceased donor transplantation. We normatively examine these considerations and discuss their implications for the ethical conduct of research. In addition to the complexities of research involving critically ill, dying or recently deceased individuals, uncertainty may arise regarding the ethical status of various individuals who may be involved in research aimed at improving availability and outcomes of organ transplantation. Consequently, routine ethical guidelines for clinical research may fail to provide clear guidance with regards to the design, conduct and governance of some deceased donation or transplantation studies. Ethical uncertainty may result in delays or barriers to research, or neglect of important ethical considerations. Specific ethical guidance is needed to support research in deceased donation and transplantation as the ethical considerations that arise in the design and conduct of such research may not be addressed in the existing guidelines for human research.

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Research Consent Models Used in Prospective Studies of Neurologically Deceased Organ Donors: A Systematic Review

Cited by 5 publications

References 27 publications

Transplant Recipient Preferences Regarding Organ Donor Research: Their Role in Consent and use of Their Data

Transplant Recipient Preferences Regarding Organ Donor Research: Their Role in Consent and use of Their Data

Research and Innovation in Organ Donation: Recommendations From an International Consensus Forum

Addressing ethical confusion in deceased donation and transplantation research: the need for dedicated guidance

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