Responsible use of organoids in precision medicine: the need for active participant involvement

Lensink, Michael A.; Jongsma, Karin; Boers, Sarah N.; Noordhoek, Jacquelien; Beekman, Jeffrey M.; Bredenoord, Annelien L.

doi:10.1242/dev.177972

Cited by 17 publications

(33 citation statements)

References 80 publications

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“…The governance of such organoid biobanks should be organized in a manner that suits the goals, stakeholders and values at stake. Several projects have been set up to include stakeholders of organoid biobanks in an early phase, in order to align the design and governance of these biobanks with researchers, patient organizations, private parties (biotech) and ethicists (see also 5 participatory design) [23]. One example to achieve ongoing involvement during the biobanking activities is for example working with 'consent for governance', that entails an initial consent procedure that provides donors with information on governance and shifts the ethical emphasis from initial consent to ongoing governance obligations, which include protection of donor privacy, participant engagement, benefit sharing and oversight [21].…”

Section: Ethics Parallel Research: 6 Ingredientsmentioning

confidence: 99%

Ethics parallel research: an approach for (early) ethical guidance of biomedical innovation

Jongsma

Bredenoord

2020

BMC Med Ethics

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Background: Our human societies and certainly also (bio) medicine are more and more permeated with technology. There seems to be an increasing awareness among bioethicists that an effective and comprehensive approach to ethically guide these emerging biomedical innovations into society is needed. Such an approach has not been spelled out yet for bioethics, while there are frequent calls for ethical guidance of biomedical innovation, also by biomedical researchers themselves. New and emerging biotechnologies require anticipation of possible effects and implications, meaning the scope is not evaluative after a technology has been fully developed or about hypothetical technologies, but real-time for a real biotechnology. Main text: In this paper we aim to substantiate and discuss six ingredients that we increasingly see adopted by ethicists and that together constitute "ethics parallel research". This approach allows to fulfil two aims: guiding the development process of technologies in biomedicine and providing input for the normative evaluation of such technologies. The six ingredients of ethics parallel research are: (1) disentangling wicked problems, (2) upstream or midstream ethical analysis, (3) ethics from within, (4) inclusion of empirical research, (5) public participation and (6) mapping societal impacts, including hard and soft impacts. We will draw on gene editing, organoid technology and artificial intelligence as examples to illustrate these six ingredients. Conclusion: Ethics parallel research brings together these ingredients to ethically analyse and proactively or parallel guide technological development. It widens the roles and judgements from the ethicist to a more anticipatory and constructively guiding role. Ethics parallel research is characterised by a constructive, rather than a purely critical perspective, it focusses on developing best-practices rather than outlining worst practice, and draws on insights from social sciences and philosophy of technology.

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Section: Ethics Parallel Research: 6 Ingredientsmentioning

confidence: 99%

Ethics parallel research: an approach for (early) ethical guidance of biomedical innovation

Jongsma

Bredenoord

2020

BMC Med Ethics

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“…When tissue is completely de-identified, it is felt that the interests and privacy of donors are adequately protected [ 60 ]. However, multiple articles in our sample argued that today, complete anonymity of human tissue is neither possible, nor desirable, due to the following three reasons [ 30 , 57 – 62 , 68 ]. Firstly, whether absolute anonymity of human tissue is possible in organoid research is considered questionable given the current developments in big data research and genomics.…”

Section: Resultsmentioning

confidence: 99%

“…Firstly, whether absolute anonymity of human tissue is possible in organoid research is considered questionable given the current developments in big data research and genomics. In the case of organoids, data (re)identification is especially relevant, because organoids could be made out of human tissues from donors with rare mutations and/or diseases, like cystic fibrosis (CF) [ 57 , 59 , 62 , 68 ]. Therefore, the anonymity of these donors cannot be guaranteed.…”

Section: Resultsmentioning

confidence: 99%

“…Secondly, complete de-identification is not desirable, because de-identification makes organoids scientifically and clinically less useful. For instance, when the coupling of organoids with personal and biological data is missing, organoids are unsuitable for precision medicine [ 30 , 59 , 62 , 67 , 68 ], as diagnoses, drug possibilities, or other relevant research results cannot be returned to donors. Not only will organoid research be less useful for patients, it will also not be possible, for instance, to validate prediction models based on data generated from organoids.…”

Section: Resultsmentioning

confidence: 99%

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Organoids: a systematic review of ethical issues

Jongh

Massey

Berishvili³

et al. 2022

Stem Cell Res Ther

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Organoids are 3D structures grown from pluripotent stem cells derived from human tissue and serve as in vitro miniature models of human organs. Organoids are expected to revolutionize biomedical research and clinical care. However, organoids are not seen as morally neutral. For instance, tissue donors may perceive enduring personal connections with their organoids, setting higher bars for informed consent and patient participation. Also, several organoid sub-types, e.g., brain organoids and human–animal chimeric organoids, have raised controversy. This systematic review provides an overview of ethical discussions as conducted in the scientific literature on organoids. The review covers both research and clinical applications of organoid technology and discusses the topics informed consent, commercialization, personalized medicine, transplantation, brain organoids, chimeras, and gastruloids. It shows that further ethical research is needed especially on organoid transplantation, to help ensure the responsible development and clinical implementation of this technology in this field.

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“…The consent procedure is and should remain a core element of any biobanking governance framework in order to ensure voluntary, well-informed participation. But there are additional interests at play within the context organoid biobanking aimed at precision medicine that we believe call for an emphasis shift in governance [25] . Several approaches have been proposed that envision such a shift, such as 'dynamic' consent or 'consent for governance' [ 15 , 47-50 ].…”

Section: Consent: More Than An Administrative Toolmentioning

confidence: 99%

Organoids for personalized treatment of Cystic Fibrosis: Professional perspectives on the ethics and governance of organoid biobanking

Lensink

Boers

Jongsma

et al. 2021

Journal of Cystic Fibrosis

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Background: Organoid technology is emerging rapidly as a valuable tool for precision medicine, particularly in the field of Cystic Fibrosis (CF). However, biobank storage and use of patient-derived organoids raises specific ethical and practical challenges that demand sound governance. We examined the perspectives of professionals affiliated with CF or organoids on the ethical aspects of organoid biobanking for CF precision medicine. By conducting this study parallel to the process of innovation and development of organoid biobanking, its findings are valuable for the design of responsible governance frameworks.Methods: To identify relevant themes and attitudes we conducted 21 semi-structured qualitative interviews with professionals in the field of organoid technology, biobanking, or CF research and care. Results:We identified three key challenges, as well as the suggestions of professionals on how to address them: (1) The challenges associated with commercial involvement, trust, and ownership, (2) Navigating the blurring boundary between research and clinical care, (3) Appropriate approaches to the informed consent procedure. Conclusion:Sound governance of organoid biobanks aimed at precision medicine requires coming to terms with the fact that its stakeholders no longer belong to separate domains. Responsible governance should be aimed at finding a sound, context-sensitive balance between integration of ongoing co-operation and mutual consideration of interests, and maintaining a feasible and sustainable research climate.

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Responsible use of organoids in precision medicine: the need for active participant involvement

Cited by 17 publications

References 80 publications

Ethics parallel research: an approach for (early) ethical guidance of biomedical innovation

Ethics parallel research: an approach for (early) ethical guidance of biomedical innovation

Organoids: a systematic review of ethical issues

Organoids for personalized treatment of Cystic Fibrosis: Professional perspectives on the ethics and governance of organoid biobanking

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