The action intends to explore the attitudes of the various stakeholders, including the research community, patients, donors and the public (taking into account gender aspects, where relevant), towards this type of research and innovation and its ethical implications. A comparative analysis of the perceived ethical implications with a similar group/family of technologies (for example bioelectronics) should be carried out.
The action should examine the impact of organoïd-based technologies, with a view to identifying the necessary elements that could best support the research community in integrating the ethics dimension into their research protocols.
A comparison within the EU and with other regions of the world, on the legal/regulatory and procedural framework (existing or under development) as well as on the level of societal awareness and acceptance, constitutes an important element of the work. Such an analysis should integrate the role of ethics committees and other advisory and regulatory structures.
The work undertaken is expected to produce (A) operational guidelines for the field. The guidelines should ensure “ethics by design” and be drafted to support the work of the research community, research ethics committees and integrity bodies. They should be in line with the new European code of conduct for research integrity[[European Code of Conduct for Research Integrity of ALLEA (All European Academies) http://ec.europa.eu/research/participants/data/ref/h2020/other/hi/h2020-ethics_code-of-conduct_en.pdf .]]. The guidelines should include clear guidance for informed consent processes as well as guidance for the clinical applications of such research. They must also cover the governance of organoid biobanks.
The action should also propose (B) a code of responsible conduct for researchers (in academia and industry), taking into account the expectations of the different stakeholders. This is best achieved by actively involving civil society organisations and panels of citizens from different socio-economic groups including vulnerable populations.
Considering the rapid scientific evolution of the field, ways to enhance the existing ethics and normative frameworks (C) should be proposed.
As regards the research integrity aspects per se, the need to complement the above mentioned European Code with specific guidelines should be assessed. If needed, a proposal for (D) a short document complementing the Code should be made.
The action should, via a dedicated horizontal coordination work package, be implemented in cooperation with the action funded further to the call SwafS-29-2020, on ""The Ethics of technologies with high socio-economic impact"" which aims at performing the same work with three or four other technologies with a view to developing a detailed ethics framework for new and emerging technologies.
The action should include relevant expertise on ethics and research integrity as well as scientific and technical expertise. Furthermore, in line with the strategy for EU international cooperation in research and innovation (COM(2012)497), international cooperation is encouraged.
Publicly available results from relevant other EU funded research projects (notably PANELFIT, SHERPA, EnTIRE, SIENNA, I-CONSENT, ENERI, PRINTEGER, and TRUST) should be taken into account.
The Commission considers that proposals requesting a contribution from the EU of the order of EUR 3.00 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.
Organoïds are considered to be key in the modelling and studying the development of organs as well as the progress of diseases. As a result, organoïds may hold the key to new breakthroughs in clinical research and to the development of new drugs and toxicology testing.
At the same time, organoïds are also a source of complex ethical questions. For example, clarification is needed on whether donors have property rights over them and whether they differ from cells and tissues with regard to their legal/moral status. Moreover, the storage of organoïds may create challenges for the governance of biobanks. Due to its nature, this research may not allow for complete de-identification of data and consequently questions of informed consent, privacy and return of results are at stake. An additional ethical concern regarding organoïds relates to their application in clinical care, in particular for the capacity to assess and handle the safety related issues.
Although these ethical dimensions have been explored in the past in the context of other types of biomedical research, the specific features of organoïd research and its potential for clinical application call for a re-evaluation of these aspects with a view to adapting, wherever necessary, the existing legal and ethics guidelines and policies.
This action will provide a comprehensive overview of the ethical and normative aspects stemming from organoïd and similar types of research. It should also enable an effective ethics governance of such research.
It will concretely provide support to the ethics committees, research integrity bodies and other organisations confronted with these issues and ultimately lead to reducing potential risks while providing an enabling framework for researchers and innovators.
Overall, the action will contribute to the establishment of an ethics framework for new technologies which, because of their fast growing impact on citizens' everyday life, is becoming a global societal priority.