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• Published: 14 December 2022

Advancing ethics review practices in AI research

• Madhulika Srikumar   ORCID: orcid.org/0000-0002-6776-4684 1 ,
• Rebecca Finlay 1 ,
• Grace Abuhamad 2 ,
• Carolyn Ashurst 3 ,
• Rosie Campbell 4 ,
• Emily Campbell-Ratcliffe 5 ,
• Hudson Hongo 1 ,
• Sara R. Jordan 6 ,
• Joseph Lindley   ORCID: orcid.org/0000-0002-5527-3028 7 ,
• Aviv Ovadya   ORCID: orcid.org/0000-0002-8766-0137 8 &
• Joelle Pineau   ORCID: orcid.org/0000-0003-0747-7250 9 , 10  

Nature Machine Intelligence volume  4 ,  pages 1061–1064 ( 2022 ) Cite this article

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A Publisher Correction to this article was published on 11 January 2023

This article has been updated

The implementation of ethics review processes is an important first step for anticipating and mitigating the potential harms of AI research. Its long-term success, however, requires a coordinated community effort, to support experimentation with different ethics review processes, to study their effect, and to provide opportunities for diverse voices from the community to share insights and foster norms.

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As artificial intelligence (AI) and machine learning (ML) technologies continue to advance, awareness of the potential negative consequences on society of AI or ML research has grown. Anticipating and mitigating these consequences can only be accomplished with the help of the leading experts on this work: researchers themselves.

Several leading AI and ML organizations, conferences and journals have therefore started to implement governance mechanisms that require researchers to directly confront risks related to their work that can range from malicious use to unintended harms. Some have initiated new ethics review processes, integrated within peer review, which primarily facilitate a reflection on the potential risks and effects on society after the research is conducted (Box 1 ). This is distinct from other responsibilities that researchers undertake earlier in the research process, such as the protection of the welfare of human participants, which are governed by bodies such as institutional review boards (IRBs).

Box 1 Current ethics review practices

Current ethics review practices can be thought of as a sliding scale that varies according to how submitting authors must conduct an ethical analysis and document it in their contributions. Most conferences and journals are yet to initiate ethics review.

Key examples of different types of ethics review process are outlined below.

Impact statement

NeurIPS 2020 broader impact statements - all authors were required to include a statement of the potential broader impact of their work, such as its ethical aspects and future societal consequences of the research, including positive and negative effects. Organizers also specified additional evaluation criteria for paper reviewers to flag submissions with potential ethical issues.

Other examples include the NAACL 2021 and the EMNLP 2021 ethical considerations sections, which encourages authors and reviewers to consider ethical questions in their submitted papers.

Nature Machine Intelligence asks authors for ethical and societal impact statements in papers that involve the identification or detection of humans or groups of humans, including behavioural and socio-economic data.

NeurIPS 2021 paper checklist - a checklist to prompt authors to reflect on potential negative societal effects of their work during the paper writing process (as well as other criteria). Authors of accepted papers were encouraged to include the checklist as an appendix. Reviewers could flag papers that required additional ethics review by the appointed ethics committee.

Other examples include the ACL Rolling Review (ARR) Responsible NLP Research checklist, which is designed to encourage best practices for responsible research.

Code of ethics or guidelines

International Conference on Learning Representations (ICLR) code of ethics - ICLR required authors to review and acknowledge the conference’s code of ethics during the submission process. Authors were not expected to include discussion on ethical aspects in their submissions unless necessary. Reviewers were encouraged to flag papers that may violate the code of ethics.

Other examples include the ACM Code of Ethics and Professional Conduct, which considers ethical principles but through the wider lens of professional conduct.

Although these initiatives are commendable, they have yet to be widely adopted. They are being pursued largely without the benefit of community alignment. As researchers and practitioners from academia, industry and non-profit organizations in the field of AI and its governance, we believe that community coordination is needed to ensure that critical reflection is meaningfully integrated within AI research to mitigate its harmful downstream consequences. The pace of AI and ML research and its growing potential for misuse necessitates that this coordination happen today.

Writing in Nature Machine Intelligence , Prunkl et al. 1 argue that the AI research community needs to encourage public deliberation on the merits and future of impact statements and other self-governance mechanisms in conference submissions. We agree. Here, we build on this suggestion, and provide three recommendations to enable this effective community coordination, as more ethics review approaches begin to emerge across conferences and journals. We believe that a coordinated community effort will require: (1) more research on the effects of ethics review processes; (2) more experimentation with such processes themselves; and (3) the creation of venues in which diverse voices both within and beyond the AI or ML community can share insights and foster norms. Although many of the challenges we address have been previously highlighted 1 , 2 , 3 , 4 , 5 , 6 , this Comment takes a wider view, calling for collaboration between different conferences and journals by contextualizing this conversation against more recent studies 7 , 8 , 9 , 10 , 11 and developments.

Developments in AI research ethics

In the past, many applied scientific communities have contended with the potential harmful societal effects of their research. The infamous anthrax attacks in 2001, for example, catalysed the creation of the National Science Advisory Board for Biosecurity to prevent the misuse of biomedical research. Virology, in particular, has had long-running debates about the responsibility of individual researchers conducting gain-of-function research. Today, the field of AI research finds itself at a similar juncture 12 . Algorithmic systems are now being deployed for high-stakes applications such as law enforcement and automated decision-making, in which the tools have the potential to increase bias, injustice, misuse and other harms at scale. The recent adoption of ethics and impact statements and checklists at some AI conferences and journals signals a much-needed willingness to deal with these issues. However, these ethics review practices are still evolving and are experimental in nature. The developments acknowledge gaps in existing, well-established governance mechanisms, such as IRBs, which focus on risks to human participants rather than risks to society as a whole. This limited focus leaves ethical issues such as the welfare of data workers and non-participants, and the implications of data generated by or about people outside of their scope 6 . We acknowledge that such ethical reflection, beyond IRB mechanisms, may also be relevant to other academic disciplines, particularly those for whom large datasets created by or about people are increasingly common, but such a discussion is beyond the scope of this piece. The need to reflect on ethical concerns seems particularly pertinent within AI, because of its relative infancy as a field, the rapid development of its capabilities and outputs, and its increasing effects on society.

In 2020, the NeurIPS ML conference required all papers to carry a ‘broader impact’ statement examining the ethical and societal effects of the research. The conference updated its approach in 2021, asking authors to complete a checklist and to document potential downstream consequences of their work. In the same year, the Partnership on AI released a white paper calling for the field to expand peer review criteria to consider the potential effects of AI research on society, including accidents, unintended consequences, inappropriate applications and malicious uses 3 . In an editorial citing the white paper, Nature Machine Intelligence announced that it would ask submissions to carry an ethical statement when the research involves the identification of individuals and related sensitive data 13 , recognizing that mitigating downstream consequences of AI research cannot be completely disentangled from how the research itself is conducted. In another recent development, Stanford University’s Ethics and Society Review (ESR) requires AI researchers who apply for funding to identify if their research poses any risks to society and also explain how those risks will be mitigated through research design 14 .

Other developments include the rising popularity of interdisciplinary conferences examining the effects of AI, such as the ACM Conference on Fairness, Accountability, and Transparency (FAccT), and the emergence of ethical codes of conduct for professional associations in computer science, such as the Association for Computing Machinery (ACM). Other actors have focused on upstream initiatives such as the integration of ethics reflection into all levels of the computer science curriculum.

Reactions from the AI research community to the introduction of ethics review practices include fears that these processes could restrict open scientific inquiry 3 . Scholars also note the inherent difficulty of anticipating the consequences of research 1 , with some AI researchers expressing concern that they do not have the expertise to perform such evaluations 7 . Other challenges include concerns about the lack of transparency in review practices at corporate research labs (which increasingly contribute to the most highly cited papers at premier AI conferences such as NeurIPS and ICML 9 ) as well as academic research culture and incentives supporting the ‘publish or perish’ mentality that may not allow time for ethical reflection.

With the emergence of these new attempts to acknowledge and articulate unique ethical considerations in AI research and the resulting concerns from some researchers, the need for the AI research community to come together to experiment, share knowledge and establish shared best practices is all the more urgent. We recommend the following three steps.

Study community behaviour and share learnings

So far, there are limited studies that have explored the responses of ML researchers to the launch of experimental ethics review practices. To understand how behaviour is changing and how to align practice with intended effect, we need to study what is happening and share learnings iteratively to advance innovation. For example, in response to the NeurIPS 2020 requirement for broader impact statements, a paper found that most researchers surveyed spent fewer than two hours working on this process 7 , perhaps retroactively towards the end of their research, making it difficult to know whether this reflection influenced or shifted research directions or not. Surveyed researchers also expressed scepticism about the mandated reflection on societal impacts 7 . An analysis of preprints found that researchers assessed impact through the narrow lens of technical contributions (that is, describing their work in the context of how it contributes to the research space and not how it may affect society), thereby overlooking potential effects on vulnerable stakeholders 8 . A qualitative analysis of a larger sample 10 and a quantitative analysis of all submitted papers 11 found that engagement was highly variable, and that researchers tended to favour the discussion of positive effects over negative effects.

We need to understand what works. These findings, all drawn from studies examining the implementation of ethics review at NeurIPS 2020, point to a pressing need to review actual versus intended community behaviour more thoroughly and consistently to evaluate the effectiveness of ethics review practices. We recognize that other fields have considered ethics in research in different ways. To get started, we propose the following approach, building on and expanding the analysis of Prunkl et al. 1 .

First, clear articulation of the purposes behind impact statements and other ethics review requirements is needed to evaluate efficacy and motivate future iterations by the community. Publication venues that organize ethics review must communicate expectations of this process comprehensively both at the level of individual contribution and for the community at large. At the individual level, goals could include encouraging researchers to reflect on the anticipated effects on society. At the community level, goals could include creating a culture of shared responsibility among researchers and (in the longer run) identifying and mitigating harms.

Second, because the exercise of anticipating downstream effects can be abstract and risks being reduced to a box-ticking endeavour, we need more data to ascertain whether they effectively promote reflection. Similar to the studies above, conference organizers and journal editors must monitor community behaviour through surveys with researchers and reviewers, partner with information scientists to analyse the responses 15 , and share their findings with the larger community. Reviewing community attitudes more systematically can provide data both on the process and effect of reflecting on harms for individual researchers, the quality of exploration encountered by reviewers, and uncover systemic challenges to practicing thoughtful ethical reflection. Work to better understand how AI researchers view their responsibility about the effects of their work in light of changing social contexts is also crucial.

Evaluating whether AI or ML researchers are more explicit about the downsides of their research in their papers is a preliminary metric for measuring change in community behaviour at large 2 . An analysis of the potential negative consequences of AI research can consider the types of application the research can make possible, the potential uses of those applications, and the societal effects they can cause 4 .

Building on the efforts at NeurIPS 16 and NAACL 17 , we can openly share our learnings as conference organizers and ethics committee members to gain a better understanding of what does and does not work.

Community behaviour in response to ethics review at the publication stage must also be studied to evaluate how structural and cultural forces throughout the research process can be reshaped towards more responsible research. The inclusion of diverse researchers and ethics reviewers, as well as people who face existing and potential harm, is a prerequisite to conduct research responsibly and improve our ability to anticipate harms.

Expand experimentation of ethical review

The low uptake of ethics review practices, and the lack of experimentation with such processes, limits our ability to evaluate the effectiveness of different approaches. Experimentation cannot be limited to a few conferences that focus on some subdomains of ML and computing research — especially for subdomains that envision real-world applications such as in employment, policing and healthcare settings. For instance, NeurIPS, which is largely considered a methods and theoretical conference, began an ethics review process in 2020, whereas conferences closer to applications, such as top-tier conferences in computer vision, have yet to implement such practices.

Sustained experimentation across subfields of AI can help us to study actual community behaviour, including differences in researcher attitudes and the unique opportunities and challenges that come with each domain. In the absence of accepted best practices, implementing ethics review processes will require conference organizers and journal editors to act under uncertainty. For that reason, we recognize that it may be easier for publication venues to begin their ethics review process by making it voluntary for authors. This can provide researchers and reviewers with the opportunity to become familiar with ethical and societal reflection, remove incentives for researchers to ‘game’ the process, and help the organizers and wider community to get closer to identifying how they can best facilitate the reflection process.

Create venues for debate, alignment and collective action

This work requires considerable cultural and institutional change that goes beyond the submission of ethical statements or checklists at conferences.

Ethical codes in scientific research have proven to be insufficient in the absence of community-wide norms and discussion 1 . Venues for open exchange can provide opportunities for researchers to share their experiences and challenges with ethical reflection. Such venues can be conducive to reflect on values as they evolve in AI or ML research, such as topics chosen for research, how research is conducted, and what values best reflect societal needs.

The establishment of venues for dialogue where conference organizers and journal editors can regularly share experiences, monitor trends in attitudes, and exchange insights on actual community behaviour across domains, while considering the evolving research landscape and range of opinions, is crucial. These venues would bring together an international group of actors involved throughout the research process, from funders, research leaders, and publishers to interdisciplinary experts adopting a critical lens on AI impact, including social scientists, legal scholars, public interest advocates, and policymakers.

In addition, reflection and dialogue can have a powerful role in influencing the future trajectory of a technology. Historically, gatherings convened by scientists have had far-reaching effects — setting the norms that guide research, and also creating practices and institutions to anticipate risks and inform downstream innovation. The Asilomar Conference on Recombinant DNA in 1975 and the Bermuda Meetings on genomic data sharing in the 1990s are instructive examples of scientists and funders, respectively, creating spaces for consensus-building 18 , 19 .

Proposing a global forum for gene-editing, scholars Jasanoff and Hulburt argued that such a venue should promote reflection on “what questions should be asked, whose views must be heard, what imbalances of power should be made visible, and what diversity of views exist globally” 20 . A forum for global deliberation on ethical approaches to AI or ML research will also need to do this.

By focusing on building the AI research field’s capacity to measure behavioural change, exchange insights, and act together, we can amplify emerging ethical review and oversight efforts. Doing this will require coordination across the entire research community and, accordingly, will come with challenges that need to be considered by conference organizers and others in their funding strategies. That said, we believe that there are important incremental steps that can be taken today towards realizing this change. For example, hosting an annual workshop on ethics review at pre-eminent AI conferences, or holding public panels on this subject 21 , hosting a workshop to review ethics statements 22 , and bringing conference organizers together 23 . Recent initiatives undertaken by AI research teams at companies to implement ethics review processes 24 , better understand societal impacts 25 and share learnings 26 , 27 also show how industry practitioners can have a positive effect. The AI community recognizes that more needs to be done to mitigate this technology’s potential harms. Recent developments in ethics review in AI research demonstrate that we must take action together.

Change history

11 january 2023.

A Correction to this paper has been published: https://doi.org/10.1038/s42256-023-00608-6

Prunkl, C. E. A. et al. Nat. Mach. Intell. 3 , 104–110 (2021).

Article   Google Scholar  

Hecht, B. et al. Preprint at https://doi.org/10.48550/arXiv.2112.09544 (2021).

Partnership on AI. https://go.nature.com/3UUX0p3 (2021).

Ashurst, C. et al. https://go.nature.com/3gsQfvp (2020).

Hecht, B. https://go.nature.com/3AASZhf (2020).

Ashurst, C., Barocas, S., Campbell, R., Raji, D. in FAccT ‘22: 2022 ACM Conf. on Fairness, Accountability, and Transparency 2057–2068 (2022).

Abuhamad, G. et al. Preprint at https://arxiv.org/abs/2011.13032 (2020).

Boyarskaya, M. et al. Preprint at https://arxiv.org/abs/2011.13416 (2020).

Birhane, A. et al. in FAccT ‘ 22: 2022 ACM Conference on Fairness, Accountability, and Transparency 173–184 (2022).

Nanayakkara, P. et al. in AIES ‘ 21: Proc. 2021 AAAI/ACM Conference on AI, Ethics, and Society 795–806 (2021).

Ashurst, C., Hine, E., Sedille, P. & Carlier, A. in FAccT ‘22: 2022 ACM Conf. on Fairness, Accountability, and Transparency 2047–2056 (2022).

National Academies of Sciences, Engineering, and Medicine. https://go.nature.com/3UTKOEJ (date accessed 16 September 2022).

Nat. Mach. Intell . 3 , 367 (2021).

Bernstein, M. S. et al. Proc. Natl Acad. Sci. USA 118 , e2117261118 (2021).

Pineau, J. et al. J. Mach. Learn. Res. 22 , 7459–7478 (2021).

Google Scholar  

Benjio, S. et al. Neural Information Processing Systems. https://go.nature.com/3tQxGEO (2021).

Bender, E. M. & Fort, K. https://go.nature.com/3TWnbua (2021).

Gregorowius, D., Biller-Andorno, N. & Deplazes-Zemp, A. EMBO Rep. 18 , 355–358 (2017).

Jones, K. M., Ankeny, R. A. & Cook-Deegan, R. J. Hist. Biol. 51 , 693–805 (2018).

Jasanoff, S. & Hurlbut, J. B. Nature 555 , 435–437 (2018).

Partnership on AI. https://go.nature.com/3EpQwY4 (2021).

Sturdee, M. et al. in CHI Conf.Human Factors in Computing Systems Extended Abstracts (CHI ’21 Extended Abstracts) ; https://doi.org/10.1145/3411763.3441330 (2021).

Partnership on AI. https://go.nature.com/3AzdNFW (2022).

DeepMind. https://go.nature.com/3EQyUWT (2022).

Meta AI. https://go.nature.com/3i3PBVX (2022).

Munoz Ferrandis, C. OpenRAIL; https://huggingface.co/blog/open_rail (2022).

OpenAI. https://go.nature.com/3GyZPYk (2022).

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Partnership on AI, San Francisco, CA, USA

Madhulika Srikumar, Rebecca Finlay & Hudson Hongo

ServiceNow, Santa Clara, CA, USA

Grace Abuhamad

The Alan Turing Institute, London, UK

Carolyn Ashurst

OpenAI, San Francisco, CA, USA

Rosie Campbell

Centre for Data Ethics and Innovation, London, UK

Emily Campbell-Ratcliffe

Future of Privacy Forum, Washington, DC, USA

Sara R. Jordan

Design Research Works, Lancaster University, Lancaster, UK

Joseph Lindley

Belfer Center for Science and International Affairs, Harvard Kennedy School, Cambridge, MA, USA

Aviv Ovadya

Meta AI, Menlo Park, CA, USA

Joelle Pineau

McGill University, Montreal, Canada

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Srikumar, M., Finlay, R., Abuhamad, G. et al. Advancing ethics review practices in AI research. Nat Mach Intell 4 , 1061–1064 (2022). https://doi.org/10.1038/s42256-022-00585-2

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Preparing ethical review systems for emergencies: next steps

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Ethical review systems need to build on their experiences of COVID-19 research to enhance their preparedness for future pandemics. Recommendations from representatives from over twenty countries include: improving relationships across the research ecosystem; demonstrating willingness to reform and adapt systems and processes; and making the case robustly for better resourcing.

Ethical preparedness and ethical review

There is a growing recognition that being ‘ethically prepared’ is an important part of emergency preparedness, by helping facilitate an effective and ethical research-led response to pandemics [ 1 , 2 ]. This includes preparedness of the ethical review system: at local, national, regional, and global level; and across multiple domains including the capacities of committee systems, staff and members. In recognition of the key role within research ecosystems played by ethical review systems during emergencies, in September 2022 the Health Ethics and Governance Unit of the World Health Organization (WHO) brought together representatives from over twenty countries at a pre-workshop to the Global Summit of National Ethics Committees in Lisbon, Portugal. Attendees took stock of their collective experiences of ethical review during COVID-19 and other epidemics, and explored how better to prepare for emergencies in the future. In this paper, we present the key findings and recommendations that resulted from that meeting. The discussion at the meeting was largely concerned with national-level policies and experiences without distinguishing between different forms of research. By implication, specific references to research generally related to clinical trials, although other kinds of research were briefly touched upon by some speakers, and the findings and recommendations should be read in that light. Further exploration is required to understand ethics committees’ experiences of diverse research approaches, and how these are integrated, both in emergency and non-emergency contexts.

Learning from past emergencies

In the years preceding the emergence of COVID-19, substantial progress was made in planning for flexible and effective ethical review of research during emergencies, building on experiences in previous outbreaks including SARS, H1N1 pandemic influenza, Ebola and Zika. Detailed guidance and recommendations were produced targeting both global [ 1 , 3 , 4 ] and regional [ 5 ] audiences; in many cases these were developed in partnership with those facing these ethical challenges on the ground including members of national ethics committees, the ALERRT clinical research network, and ethicists participating in the Zika Ethics Consultation initiated by the Pan American Health Organization (PAHO). Training materials addressing emergency contexts were produced to support capacity strengthening within individual research ethics committees [ 6 , 7 ], as were indicators to promote and support a more strategic approach to ethics systems at national level [ 8 ].

This work paid dividends in early 2020 as the nature and extent of the COVID-19 pandemic became clear. Leadership from WHO at both headquarters [ 9 ] and regional [ 10 ] level resulted in the rapid production of COVID-19-specific ethical guidance and materials, with the important role played by research ethics committees in emergency response also recognised by key regional bodies [ 11 ]. WHO’s own processes of ethical review at headquarters and regional level were also rapidly adapted to expedite the review of priority studies. Speakers at the meeting noted how Regional Offices played an important facilitative role behind the scenes, for example in helping tackle bottlenecks in systems, and promoting dialogue with other stakeholders in healthcare such as traditional medicine practitioners. In some countries, national research ethics bodies took a leading role in rapidly developing systems, guidance and support in response to their own countries’ needs.

What went well as a result of initiatives to promote ethical preparedness

Attendees at the Lisbon meeting shared examples of how these elements of ethical preparedness had helped support good practice in their own countries as they sought to respond to the unprecedented challenges of the COVID-19 pandemic (see Table 1 ). In addition to the development of flexible, responsive review procedures at the level of individual committees, contributors emphasised the importance of rapidly establishing national strategies to clarify the respective roles and responsibilities of different levels of committee and their relationship with other parts of the research oversight system [ 12 ].

Remaining challenges

Nevertheless, significant challenges remain: some arising directly out of the emergency context, and others illustrating how unresolved issues within ethical review (in particular how best to review multi-site and multi-country studies) arise in particularly acute form in emergencies. Common experiences from research ethics committees around the globe, shared at the Lisbon meeting, included:

Extraordinary pressure on both national and local-level research ethics committees , with very high numbers of applications to review, coupled with similarly high numbers of amendments to existing studies in order to comply with COVID-related public health restrictions. The intense nature of the working environment was compounded by competing professional commitments for those involved, social and researcher pressure to ‘do something’, and in some cases strong political pressures to approve studies regardless of ethical or scientific concerns. Such pressures lead to burn-out, particularly when sustained over an extended period.

Inadequate resourcing , over and above existing well-recognised limitations in many countries. The large increases in funding made available for research as part of the emergency response to COVID-19 did not trickle through to review processes, despite the enormous increase in the number of applications, and the expectations of rapid response.

Capacity challenges , particularly for committees with less experience of reviewing complex trial designs, innovative methodologies, and multi-country studies. Inevitably these challenges were particularly acute for committees that were already inadequately resourced and supported.

Difficulties in negotiating the opportunity costs inherent in prioritising COVID-19 related studies . While establishing a separate ad hoc committee for fast-track reviews could be helpful, identifying which studies should be expedited for review was not straightforward, especially given concerns as to how many registered clinical trials for COVID-19 interventions were inadequately powered to produce reliable results [ 13 , 14 ]. The scope for potential research waste raises difficult questions for research ethics committees, and highlights the responsibilities of other stakeholders to act earlier in the research process to prioritise and co-ordinate research proposals from a public health perspective.

The variable quality of studies , including data and tissue management plans that lacked clarity or detail because of pressure of time. It was reported that at times inadequate expert scientific scrutiny before studies were submitted for ethical review increased the burden of scrutiny on research ethics committees.

Co-ordinated review of multi-site studies in-country : while some countries reported how such studies were referred directly to a designated committee (including, for example, in Brazil, Panama, Barbados, Egypt, New Zealand), national strategies of this kind were far from universally in place and implemented. As already recommended by PAHO and widely implemented in Latin America [ 15 ], there is an urgent need for all countries to devise and implement a national (or subregional, or provincial, as relevant) strategy to organize ethics review in emergencies, and allocate responsibilities, in ways that minimise duplication and delay, particularly for multi-site studies. Such strategies also need to be able to account for how ethical issues specific to particular sites will be appropriately handled.

Co-ordinated review of multi-country studies : where multi-site studies also involve multiple countries, ensuring effective and timely review remains even more challenging, including also scope for tension between national and WHO-level review. The African Vaccine Regulatory Forum (AVAREF) has developed a model, whereby delegates from a number of participating countries come together in a joint meeting to discuss a protocol, with decisions then being delivered by the relevant committee in each country within an agreed timescale, informed by a shared understanding of the proposal [ 16 ]. Alternative possible models include exploration of circumstances in which mutual recognition by ethics committees of each other’s judgments could be acceptable. More ambitiously still, future consideration could be given to the creation of regional committees (or even a global committee) with a specific mandate to review protocols for research in emergencies on behalf of participating countries, coupled with the option of local review with respect to site-specific factors. In order to be successful, such an initiative would, however, require willingness to achieve any necessary legislative change at the level of national jurisdictions. Research on different models of research ethics cooperation is urgently needed in order to foster innovation and evaluate different models. Such approaches also need to be sensitive to the heterogeneity and diverse contexts of different ethics committees.

What is needed to improve preparedness for the next public health emergency?

Attendees identified four priorities to take forward a more ethically-prepared ethical review system (Table 2 ).

First, all agreed that ‘more guidance’ was not required at this point, other than in connection with specific issues such as novel study designs [ 17 ]. Rather, action is required by multiple stakeholders to translate existing guidance into practice. The recommendations produced in 2018 as a result of the meeting co-hosted by WHO and ALERRT [ 1 ], for example, proved to be highly relevant in responding to the challenges of COVID-19 alongside further regional-level guidance reiterating the importance of national strategies [ 8 ]. The rapid and flexible turnaround achieved by some committees confounds the myth that ethical review is necessarily a stumbling block to rapid research.

Nevertheless, much remains to be done on a global scale to consolidate existing guidance from diverse sources (as PAHO has already done for its stakeholders in the Americas [ 10 ]); to share the good practice and tools developed by many ethics committees; and to achieve the systems and structures necessary to act on those recommendations, with diverse stakeholders bearing responsibility for different aspects (see Table 3 below). In particular, all these stakeholders have a role to play in ensuring that countries have in place models of multi-country review that provide effective, responsive review, and meet each country’s needs for accountability and control, while minimising duplication of effort and delay.

Second, critical (internal) scrutiny is required of what the ethical review system offers, and how it fulfils its remit. Such scrutiny and action needs to take place during inter-pandemic periods, in order to support better emergency preparedness for the future. It was argued that there is an onus on everyone involved in ethical review to make the case for the value that the review process can bring in prompting explicit consideration of the values that should inform decision-making during the entire research process. Research ethics committees will be much better placed to achieve this outcome if they are perceived not as a negative, adversarial, hurdle in the research system, but rather as a contributor in the production of better, socially-valuable, research. This recognition that everyone concerned in research shares responsibilities for the ethical conduct of that research is particularly important in the testing circumstances of a public health emergency. Alongside building on the more flexible and responsive approaches developed during the pandemic, such a shift in perception will require:

Genuine willingness on the part of ethics committees to test themselves as to how they add value – including reviewing their own processes from the point of view of researchers, sponsors and others.

Recognizing the need for those involved in bioethics to take teaching research ethics seriously, so that researchers of the future have a better understanding of the ethical aspects of their work, and what value ethical review can bring. In addition to contributing to undergraduate teaching within health sciences curricula (medicine, pharmacy, dentistry, nursing, allied health sciences, etc.), this could involve taking part in initiatives such as roadshows to improve knowledge and understanding of ethical review, providing training materials, and using newsletters and social media platforms to raise the profile of ethical review.

Making the case proactively to researchers for how timely identification of ethical concerns actively benefits research outcomes – for example how making the case for equitable and inclusive recruitment practices may lead to tangible benefits such as greater confidence and trust in novel interventions when they are translated into practice [ 18 ].

Exploring the development of quality indicators to help cement trust between and within committees, researchers and other research stakeholders, and help identify, at the level of individual committees, where changes in practice would be beneficial. Such indicators could build on current work by WHO on benchmarking tools for ethics committees [ 19 ], and on a regional initiative by PAHO on indicators for core components of research ethics systems [ 20 ], to capture both substantive elements (the value added to the study as a result of ethical scrutiny) and valued performance elements such as flexibility and timeliness. Examples of initiatives in this area shared by meeting attendees included the development of performance indicators in Egypt; while in New Zealand, a new ‘decision analyses’ process will be used to identify what ethical issues most frequently lead to applications requiring revision, and then consider whether more training or guidance is required, or whether the standards themselves require review.

Seeking funding for research into research ethics: using applied research and quality improvement processes to identify and solve persistent problems in research ethics processes. Key questions for such research to address would include: substantive elements such as understanding of optimal consent and community engagement processes, particularly in connection with novel research approaches; procedural questions, such as optimal training and composition of committees; and perceptual/relational issues regarding how relationships between committees and researchers could be improved [ 21 ].

Third: action to support capacity, skills and confidence, particularly with reference to complex and innovative trial designs. The need to support mutual learning, at both local and international level, was strongly emphasised by attendees, with suggestions including the creation of a ‘learning research ethics committee system’ (echoing the concept of a learning healthcare system) and the development of a ‘community of practice’ for mutual learning among research ethics committee members. Such approaches highlight again the important role of effective networking between ethics committee members, and the scope for WHO at both regional and global level to support this.

Fourth: None of this can be achieved without adequate funding of ethical review infrastructure. Ethics committees need a permanent office, space, staff, infrastructure (including increasingly sophisticated online platforms and software) and budget to run their functions and contribute effectively to the shared aim of facilitating ethically-conducted research. Consideration must also be given to when and how it might be appropriate to compensate committee members, recognising that relying on unpaid labour to carry out a critical part of the research oversight system is not only unsustainable at these levels of pressure but also carries a message about how that labour, and the skills required to conduct it, are valued [ 12 ]. Recognising all these factors, attendees felt that it is time for research ethics infrastructure to receive a set percentage of research funding, levied at source, and allocated in such a way as to provide for a sustainable committee system that has the time, capacity and skills to contribute consistently to the improvement of research proposals.

Investment in ethical preparedness in the years preceding the emergence of the COVID-19 pandemic enabled research ethics committees in many parts of the world to contribute flexibly and promptly to the global research-led emergency response. Significant challenges, however, remain, in light of the extreme pressure placed on ethical review systems by factors including high numbers of emergency research proposals, testing timeframes, political exigencies, inadequate infrastructure and support, and the inherent complexities of multi-site, multi-country studies.

In order to be able to respond effectively in future emergencies, research ethics committees need to be better prepared, better resourced, and better connected, both with each other and with the rest of the research ecosystem. They need to be recognized as offering added value for researchers and funders, helping design better studies and improving respect for participants’ rights, instead of being perceived as an obstacle to innovation and research development. When research ethics committees are seen as an essential part of the whole research process then, as a society, we will be better prepared to face the next emergency.

Diverse stakeholders, including national governments, national and local research ethics bodies, WHO, research funders, and researchers themselves, all have their part to play in achieving such a transformation. In particular, as an ethics community, we need to be better at consolidating guidance and translating it into practice; we need to enhance our relationships with other parts of the research ecosystem, including the transparency with which we operate; we need to be willing to reform and adapt our systems and processes; and we need to make the case robustly that better resourcing is key.

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Saxena A, Horby P, Amuasi J, Aagaard N, Köhler J, Shamsi Gooshki E, et al. Ethics preparedness: facilitating ethics review during outbreaks - recommendations from an expert panel. BMC Med Ethics. 2019;20:29. https://doi.org/10.1186/s12910-019-0366-x .

Article   Google Scholar  

Saenz C. Zika virus: ethics preparedness for old and new challenges. Lancet Glob Health. 2016;4:e686. https://doi.org/10.1016/S2214-109X(16)30222-4 .

World Health Organization. Research ethics in international epidemic response. 2010. https://apps.who.int/iris/handle/10665/70739 .

World Health Organization. Guidance for managing ethical issues in infectious disease outbreaks. 2016. https://apps.who.int/iris/handle/10665/250580 .

Pan American Health Organization. Zika ethics consultation: ethics guidance on key issues raised by the outbreak. 2016. https://iris.paho.org/handle/10665.2/28425 .

World Health Organization. Ethics in epidemics, emergencies and disasters: Research, surveillance and patient care: training manual. 2015. https://www.who.int/publications/i/item/9789241549349 .

Global Health Training Centre in collaboration with Nuffield Council on Bioethics. Research in global health emergencies: ethical issues: specialist short course. 2020. https://globalhealthtrainingcentre.tghn.org/research-global-health-emergencies-ethical-issues/ .

Neil M, Saenz C. Advancing research ethics systems in Latin America and the Caribbean: a path for other LMICs? Lancet Glob Health. 2020;8:e23–4. https://doi.org/10.1016/S2214-109X(19)30441-3 .

World Health Organization: Ethics and COVID-19. https://www.who.int/teams/health-ethics-governance/diseases/covid-19 . Accessed 6 June 2023.

Pan American Health Organization. Catalyzing ethical research in emergencies. Ethics guidance, lessons learned from the COVID-19 pandemic, and pending agenda. https://www.paho.org/en/bioethics/catalyzing-ethical-research-emergencies-ethics-guidance-lessons-learned-covid-19-pandemic . Accessed 6 June 2023.

European Medicines Agency. Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic. 2022. https://health.ec.europa.eu/system/files/2022-02/guidanceclinicaltrials_covid19_en_1.pdf .

Pan America Health Organization. Catalyzing ethical research in emergencies. Ethics guidance, lessons learned from the COVID-19 pandemic, and pending agenda. 2022. https://iris.paho.org/handle/10665.2/56139 .

Bugin K, Woodcock J. Trends in COVID-19 therapeutic clinical trials. Nat Rev Drug Discov. 2021;20:254–5. https://doi.org/10.1038/d41573-021-00037-3 .

Carracedo S, Palmero A, Neil M, Hasan-Granier A, Saenz C, Reveiz L. The landscape of COVID-19 clinical trials in Latin America and the Caribbean: assessment and challenges. Rev Panam Salud Publica. 2020;44:177. https://doi.org/10.26633/RPSP.2020.177 .

Pan American Health Authority. Guidance and strategies to streamline ethics review and oversight of COVID-19-related research. 2020. https://iris.paho.org/handle/10665.2/52089 .

World Health Organization African Region. Overview: the AVAREF joint review process. https://www.afro.who.int/health-topics/immunization/avaref/joint-review-process . Accessed 6 June 2023.

World Health Organization. Ethical considerations in adaptive platform trials. https://www.who.int/teams/health-ethics-governance/emergencies-and-outbreaks/platform-trials . Accessed 31 Aug 2023.

Castellon-Lopez Y, Landovitz R, Ntkekume E, Porter C, Bross R, Hilder R, et al. A community-partnered approach for diversity in COVID-19 vaccine clinical trials. J Clin Transl Sci. 2023;7(1):e23. https://doi.org/10.1017/cts.2022.471 .

World Health Organization. WHO tool for benchmarking ethics oversight of health-related research with human participants: Draft version for piloting. October 2022. https://www.who.int/publications/m/item/who-tool-for-benchmarking-ethics-oversight-of-health-related-research-with-human-participants .

Aguilera B, Carracedo S, Saenz C. Research ethics systems in Latin America and the Caribbean: a systemic assessment using indicators. Lancet Glob Health. 2022;10(8):e1204-1208. https://doi.org/10.1016/S2214-109X(22)00128-0 .

Upshur REG. Ask not what your REB can do for you; ask what you can do for your REB. Can Fam Physician. 2011;57(10):1113–4.

Google Scholar  

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Acknowledgements

We gratefully acknowledge the input of all those who attended the pre-summit workshop in Lisbon on 14 th September 2022. In addition to the authors, attendees were: Ruhul Amin, National Research Ethics Committee, Bangladesh; Luisa Borgia, National Bioethics Committee, Republic of San Marino; Victor Chalwe, National Health Research Authority, Zambia; Michel Daher, Lebanese National Ethics Committee, Lebanon; Sunil De Alwis, Ministry of Health, Sri Lanka; Lotta Eriksson, Swedish National Council on Medical Ethics, Sweden; Dirceu Greco, CONEP, Brazil; Manju Rani, WHO SEARO; Patricio Santillan, National Bioethics Commission of Mexico; Voo Teck Chuan, Bioethics Advisory Committee and National Medical Ethics Committee, Singapore; Rita Trujillo National Committee of Bioethics in Research, Panama; Dalkh Tserendagva, Medical Ethics Committee, Mongolia.

The meeting from which this article was developed was supported by USDOS funding for WHO’s Global Response for COVID-19.

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Wright, K., Aagaard, N., Ali, A.Y. et al. Preparing ethical review systems for emergencies: next steps. BMC Med Ethics 24 , 92 (2023). https://doi.org/10.1186/s12910-023-00957-2

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Guest Essay

In Medicine, the Morally Unthinkable Too Easily Comes to Seem Normal

By Carl Elliott

Dr. Elliott teaches medical ethics at the University of Minnesota. He is the author of the forthcoming book “The Occasional Human Sacrifice: Medical Experimentation and the Price of Saying No,” from which this essay is adapted.

Here is the way I remember it: The year is 1985, and a few medical students are gathered around an operating table where an anesthetized woman has been prepared for surgery. The attending physician, a gynecologist, asks the group: “Has everyone felt a cervix? Here’s your chance.” One after another, we take turns inserting two gloved fingers into the unconscious woman’s vagina.

Had the woman consented to a pelvic exam? Did she understand that when the lights went dim she would be treated like a clinical practice dummy, her genitalia palpated by a succession of untrained hands? I don’t know. Like most medical students, I just did as I was told.

Last month the Department of Health and Human Services issued new guidance requiring written informed consent for pelvic exams and other intimate procedures performed under anesthesia. Much of the force behind the new requirement came from distressed medical students who saw these pelvic exams as wrong and summoned the courage to speak out.

Whether the guidance will actually change clinical practice I don’t know. Medical traditions are notoriously difficult to uproot, and academic medicine does not easily tolerate ethical dissent. I doubt the medical profession can be trusted to reform itself.

What is it that leads a rare individual to say no to practices that are deceptive, exploitative or harmful when everyone else thinks they are fine? For a long time I assumed that saying no was mainly an issue of moral courage. The relevant question was: If you are a witness to wrongdoing, will you be brave enough to speak out?

But then I started talking to insiders who had blown the whistle on abusive medical research. Soon I realized that I had overlooked the importance of moral perception. Before you decide to speak out about wrongdoing, you have to recognize it for what it is.

This is not as simple as it seems. Part of what makes medical training so unsettling is how often you are thrust into situations in which you don’t really know how to behave. Nothing in your life up to that point has prepared you to dissect a cadaver, perform a rectal exam or deliver a baby. Never before have you seen a psychotic patient involuntarily sedated and strapped to a bed or a brain-dead body wheeled out of a hospital room to have its organs harvested for transplantation. Your initial reaction is often a combination of revulsion, anxiety and self-consciousness.

To embark on a career in medicine is like moving to a foreign country where you do not understand the customs, rituals, manners or language. Your main concern on arrival is how to fit in and avoid causing offense. This is true even if the local customs seem backward or cruel. What’s more, this particular country has an authoritarian government and a rigid status hierarchy where dissent is not just discouraged but also punished. Living happily in this country requires convincing yourself that whatever discomfort you feel comes from your own ignorance and lack of experience. Over time, you learn how to assimilate. You may even come to laugh at how naïve you were when you first arrived.

A rare few people hang onto that discomfort and learn from it. When Michael Wilkins and William Bronston started working at the Willowbrook State School in Staten Island as young doctors in the early 1970s, they found thousands of mentally disabled children condemned to the most horrific conditions imaginable: naked children rocking and moaning on concrete floors in puddles of their own urine; an overpowering stench of illness and filth; a research unit where children were deliberately infected with hepatitis A and B.

“It was truly an American concentration camp,” Dr. Bronston told me. Yet when he and Dr. Wilkins tried to enlist Willowbrook doctors and nurses to reform the institution, they were met with indifference or hostility. It seemed as if no one else on the medical staff could see what they saw. It was only when Dr. Wilkins went to a reporter and showed the world what was happening behind the Willowbrook walls that anything began to change.

When I asked Dr. Bronston how it was possible for doctors and nurses to work at Willowbrook without seeing it as a crime scene, he told me it began with the way the institution was structured and organized. “Medically secured, medically managed, doctor-validated,” he said. Medical professionals just accommodated themselves to the status quo. “You get with the program because that’s what you’re being hired to do,” he said.

One of the great mysteries of human behavior is how institutions create social worlds where unthinkable practices come to seem normal. This is as true of academic medical centers as it is of prisons and military units. When we are told about a horrific medical research scandal, we assume that we would see it just as the whistle-blower Peter Buxtun saw the Tuskegee syphilis study : an abuse so shocking that only a sociopath could fail to perceive it.

Yet it rarely happens this way. It took Mr. Buxtun seven years to convince others to see the abuses for what they were. It has taken other whistle-blowers even longer. Even when the outside world condemns a practice, medical institutions typically insist that the outsiders don’t really understand.

According to Irving Janis, a Yale psychologist who popularized the notion of groupthink, the forces of social conformity are especially powerful in organizations that are driven by a deep sense of moral purpose. If the aims of the organization are righteous, its members feel, it is wrong to put barriers in the way.

This observation helps explain why academic medicine not only defends researchers accused of wrongdoing but also sometimes rewards them. Many of the researchers responsible for the most notorious abuses in recent medical history — the Tuskegee syphilis study, the Willowbrook hepatitis studies, the Cincinnati radiation studies , the Holmesburg prison studies — were celebrated with professional accolades even after the abuses were first called out.

The culture of medicine is notoriously resistant to change. During the 1970s, it was thought that the solution to medical misconduct was formal education in ethics. Major academic medical centers began establishing bioethics centers and programs throughout the 1980s and ’90s, and today virtually every medical school in the country requires ethics training.

Yet it is debatable whether that training has had any effect. Many of the most egregious ethical abuses in recent decades have taken place in medical centers with prominent bioethics programs, such as the University of Pennsylvania , Duke University , Columbia University and Johns Hopkins University , as well as my own institution, the University of Minnesota .

One could be forgiven for concluding that the only way the culture of medicine will change is if changes are forced on it from the outside — by oversight bodies, legislators or litigators. For example, many states have responded to the controversy over pelvic exams by passing laws banning the practice unless the patient has explicitly given consent.

You may find it hard to understand how pelvic exams on unconscious women without their consent could seem like anything but a terrible invasion. Yet a central aim of medical training is to transform your sensibility. You are taught to steel yourself against your natural emotional reactions to death and disfigurement; to set aside your customary views about privacy and shame; to see the human body as a thing to be examined, tested and studied.

One danger of this transformation is that you will see your colleagues and superiors do horrible things and be afraid to speak up. But the more subtle danger is that you will no longer see what they are doing as horrible. You will just think: This is the way it is done.

Carl Elliott ( @FearLoathingBTX ) teaches medical ethics at the University of Minnesota. He is the author of the forthcoming book “The Occasional Human Sacrifice: Medical Experimentation and the Price of Saying No,” from which this essay is adapted.

The Times is committed to publishing a diversity of letters to the editor. We’d like to hear what you think about this or any of our articles. Here are some tips . And here’s our email: [email protected] .

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Cultural Relativity and Acceptance of Embryonic Stem Cell Research

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There is a debate about the ethical implications of using human embryos in stem cell research, which can be influenced by cultural, moral, and social values. This paper argues for an adaptable framework to accommodate diverse cultural and religious perspectives. By using an adaptive ethics model, research protections can reflect various populations and foster growth in stem cell research possibilities.

INTRODUCTION

Stem cell research combines biology, medicine, and technology, promising to alter health care and the understanding of human development. Yet, ethical contention exists because of individuals’ perceptions of using human embryos based on their various cultural, moral, and social values. While these disagreements concerning policy, use, and general acceptance have prompted the development of an international ethics policy, such a uniform approach can overlook the nuanced ethical landscapes between cultures. With diverse viewpoints in public health, a single global policy, especially one reflecting Western ethics or the ethics prevalent in high-income countries, is impractical. This paper argues for a culturally sensitive, adaptable framework for the use of embryonic stem cells. Stem cell policy should accommodate varying ethical viewpoints and promote an effective global dialogue. With an extension of an ethics model that can adapt to various cultures, we recommend localized guidelines that reflect the moral views of the people those guidelines serve.

Stem cells, characterized by their unique ability to differentiate into various cell types, enable the repair or replacement of damaged tissues. Two primary types of stem cells are somatic stem cells (adult stem cells) and embryonic stem cells. Adult stem cells exist in developed tissues and maintain the body’s repair processes. [1] Embryonic stem cells (ESC) are remarkably pluripotent or versatile, making them valuable in research. [2] However, the use of ESCs has sparked ethics debates. Considering the potential of embryonic stem cells, research guidelines are essential. The International Society for Stem Cell Research (ISSCR) provides international stem cell research guidelines. They call for “public conversations touching on the scientific significance as well as the societal and ethical issues raised by ESC research.” [3] The ISSCR also publishes updates about culturing human embryos 14 days post fertilization, suggesting local policies and regulations should continue to evolve as ESC research develops. [4]  Like the ISSCR, which calls for local law and policy to adapt to developing stem cell research given cultural acceptance, this paper highlights the importance of local social factors such as religion and culture.

I.     Global Cultural Perspective of Embryonic Stem Cells

Views on ESCs vary throughout the world. Some countries readily embrace stem cell research and therapies, while others have stricter regulations due to ethical concerns surrounding embryonic stem cells and when an embryo becomes entitled to moral consideration. The philosophical issue of when the “someone” begins to be a human after fertilization, in the morally relevant sense, [5] impacts when an embryo becomes not just worthy of protection but morally entitled to it. The process of creating embryonic stem cell lines involves the destruction of the embryos for research. [6] Consequently, global engagement in ESC research depends on social-cultural acceptability.

a.     US and Rights-Based Cultures

In the United States, attitudes toward stem cell therapies are diverse. The ethics and social approaches, which value individualism, [7] trigger debates regarding the destruction of human embryos, creating a complex regulatory environment. For example, the 1996 Dickey-Wicker Amendment prohibited federal funding for the creation of embryos for research and the destruction of embryos for “more than allowed for research on fetuses in utero.” [8] Following suit, in 2001, the Bush Administration heavily restricted stem cell lines for research. However, the Stem Cell Research Enhancement Act of 2005 was proposed to help develop ESC research but was ultimately vetoed. [9] Under the Obama administration, in 2009, an executive order lifted restrictions allowing for more development in this field. [10] The flux of research capacity and funding parallels the different cultural perceptions of human dignity of the embryo and how it is socially presented within the country’s research culture. [11]

b.     Ubuntu and Collective Cultures

African bioethics differs from Western individualism because of the different traditions and values. African traditions, as described by individuals from South Africa and supported by some studies in other African countries, including Ghana and Kenya, follow the African moral philosophies of Ubuntu or Botho and Ukama , which “advocates for a form of wholeness that comes through one’s relationship and connectedness with other people in the society,” [12] making autonomy a socially collective concept. In this context, for the community to act autonomously, individuals would come together to decide what is best for the collective. Thus, stem cell research would require examining the value of the research to society as a whole and the use of the embryos as a collective societal resource. If society views the source as part of the collective whole, and opposes using stem cells, compromising the cultural values to pursue research may cause social detachment and stunt research growth. [13] Based on local culture and moral philosophy, the permissibility of stem cell research depends on how embryo, stem cell, and cell line therapies relate to the community as a whole. Ubuntu is the expression of humanness, with the person’s identity drawn from the “’I am because we are’” value. [14] The decision in a collectivistic culture becomes one born of cultural context, and individual decisions give deference to others in the society.

Consent differs in cultures where thought and moral philosophy are based on a collective paradigm. So, applying Western bioethical concepts is unrealistic. For one, Africa is a diverse continent with many countries with different belief systems, access to health care, and reliance on traditional or Western medicines. Where traditional medicine is the primary treatment, the “’restrictive focus on biomedically-related bioethics’” [is] problematic in African contexts because it neglects bioethical issues raised by traditional systems.” [15] No single approach applies in all areas or contexts. Rather than evaluating the permissibility of ESC research according to Western concepts such as the four principles approach, different ethics approaches should prevail.

Another consideration is the socio-economic standing of countries. In parts of South Africa, researchers have not focused heavily on contributing to the stem cell discourse, either because it is not considered health care or a health science priority or because resources are unavailable. [16] Each country’s priorities differ given different social, political, and economic factors. In South Africa, for instance, areas such as maternal mortality, non-communicable diseases, telemedicine, and the strength of health systems need improvement and require more focus [17] Stem cell research could benefit the population, but it also could divert resources from basic medical care. Researchers in South Africa adhere to the National Health Act and Medicines Control Act in South Africa and international guidelines; however, the Act is not strictly enforced, and there is no clear legislation for research conduct or ethical guidelines. [18]

Some parts of Africa condemn stem cell research. For example, 98.2 percent of the Tunisian population is Muslim. [19] Tunisia does not permit stem cell research because of moral conflict with a Fatwa. Religion heavily saturates the regulation and direction of research. [20] Stem cell use became permissible for reproductive purposes only recently, with tight restrictions preventing cells from being used in any research other than procedures concerning ART/IVF.  Their use is conditioned on consent, and available only to married couples. [21] The community's receptiveness to stem cell research depends on including communitarian African ethics.

c.     Asia

Some Asian countries also have a collective model of ethics and decision making. [22] In China, the ethics model promotes a sincere respect for life or human dignity, [23] based on protective medicine. This model, influenced by Traditional Chinese Medicine (TCM), [24] recognizes Qi as the vital energy delivered via the meridians of the body; it connects illness to body systems, the body’s entire constitution, and the universe for a holistic bond of nature, health, and quality of life. [25] Following a protective ethics model, and traditional customs of wholeness, investment in stem cell research is heavily desired for its applications in regenerative therapies, disease modeling, and protective medicines. In a survey of medical students and healthcare practitioners, 30.8 percent considered stem cell research morally unacceptable while 63.5 percent accepted medical research using human embryonic stem cells. Of these individuals, 89.9 percent supported increased funding for stem cell research. [26] The scientific community might not reflect the overall population. From 1997 to 2019, China spent a total of $576 million (USD) on stem cell research at 8,050 stem cell programs, increased published presence from 0.6 percent to 14.01 percent of total global stem cell publications as of 2014, and made significant strides in cell-based therapies for various medical conditions. [27] However, while China has made substantial investments in stem cell research and achieved notable progress in clinical applications, concerns linger regarding ethical oversight and transparency. [28] For example, the China Biosecurity Law, promoted by the National Health Commission and China Hospital Association, attempted to mitigate risks by introducing an institutional review board (IRB) in the regulatory bodies. 5800 IRBs registered with the Chinese Clinical Trial Registry since 2021. [29] However, issues still need to be addressed in implementing effective IRB review and approval procedures.

The substantial government funding and focus on scientific advancement have sometimes overshadowed considerations of regional cultures, ethnic minorities, and individual perspectives, particularly evident during the one-child policy era. As government policy adapts to promote public stability, such as the change from the one-child to the two-child policy, [30] research ethics should also adapt to ensure respect for the values of its represented peoples.

Japan is also relatively supportive of stem cell research and therapies. Japan has a more transparent regulatory framework, allowing for faster approval of regenerative medicine products, which has led to several advanced clinical trials and therapies. [31] South Korea is also actively engaged in stem cell research and has a history of breakthroughs in cloning and embryonic stem cells. [32] However, the field is controversial, and there are issues of scientific integrity. For example, the Korean FDA fast-tracked products for approval, [33] and in another instance, the oocyte source was unclear and possibly violated ethical standards. [34] Trust is important in research, as it builds collaborative foundations between colleagues, trial participant comfort, open-mindedness for complicated and sensitive discussions, and supports regulatory procedures for stakeholders. There is a need to respect the culture’s interest, engagement, and for research and clinical trials to be transparent and have ethical oversight to promote global research discourse and trust.

d.     Middle East

Countries in the Middle East have varying degrees of acceptance of or restrictions to policies related to using embryonic stem cells due to cultural and religious influences. Saudi Arabia has made significant contributions to stem cell research, and conducts research based on international guidelines for ethical conduct and under strict adherence to guidelines in accordance with Islamic principles. Specifically, the Saudi government and people require ESC research to adhere to Sharia law. In addition to umbilical and placental stem cells, [35] Saudi Arabia permits the use of embryonic stem cells as long as they come from miscarriages, therapeutic abortions permissible by Sharia law, or are left over from in vitro fertilization and donated to research. [36] Laws and ethical guidelines for stem cell research allow the development of research institutions such as the King Abdullah International Medical Research Center, which has a cord blood bank and a stem cell registry with nearly 10,000 donors. [37] Such volume and acceptance are due to the ethical ‘permissibility’ of the donor sources, which do not conflict with religious pillars. However, some researchers err on the side of caution, choosing not to use embryos or fetal tissue as they feel it is unethical to do so. [38]

Jordan has a positive research ethics culture. [39] However, there is a significant issue of lack of trust in researchers, with 45.23 percent (38.66 percent agreeing and 6.57 percent strongly agreeing) of Jordanians holding a low level of trust in researchers, compared to 81.34 percent of Jordanians agreeing that they feel safe to participate in a research trial. [40] Safety testifies to the feeling of confidence that adequate measures are in place to protect participants from harm, whereas trust in researchers could represent the confidence in researchers to act in the participants’ best interests, adhere to ethical guidelines, provide accurate information, and respect participants’ rights and dignity. One method to improve trust would be to address communication issues relevant to ESC. Legislation surrounding stem cell research has adopted specific language, especially concerning clarification “between ‘stem cells’ and ‘embryonic stem cells’” in translation. [41] Furthermore, legislation “mandates the creation of a national committee… laying out specific regulations for stem-cell banking in accordance with international standards.” [42] This broad regulation opens the door for future global engagement and maintains transparency. However, these regulations may also constrain the influence of research direction, pace, and accessibility of research outcomes.

e.     Europe

In the European Union (EU), ethics is also principle-based, but the principles of autonomy, dignity, integrity, and vulnerability are interconnected. [43] As such, the opportunity for cohesion and concessions between individuals’ thoughts and ideals allows for a more adaptable ethics model due to the flexible principles that relate to the human experience The EU has put forth a framework in its Convention for the Protection of Human Rights and Dignity of the Human Being allowing member states to take different approaches. Each European state applies these principles to its specific conventions, leading to or reflecting different acceptance levels of stem cell research. [44]

For example, in Germany, Lebenzusammenhang , or the coherence of life, references integrity in the unity of human culture. Namely, the personal sphere “should not be subject to external intervention.” [45]  Stem cell interventions could affect this concept of bodily completeness, leading to heavy restrictions. Under the Grundgesetz, human dignity and the right to life with physical integrity are paramount. [46] The Embryo Protection Act of 1991 made producing cell lines illegal. Cell lines can be imported if approved by the Central Ethics Commission for Stem Cell Research only if they were derived before May 2007. [47] Stem cell research respects the integrity of life for the embryo with heavy specifications and intense oversight. This is vastly different in Finland, where the regulatory bodies find research more permissible in IVF excess, but only up to 14 days after fertilization. [48] Spain’s approach differs still, with a comprehensive regulatory framework. [49] Thus, research regulation can be culture-specific due to variations in applied principles. Diverse cultures call for various approaches to ethical permissibility. [50] Only an adaptive-deliberative model can address the cultural constructions of self and achieve positive, culturally sensitive stem cell research practices. [51]

II.     Religious Perspectives on ESC

Embryonic stem cell sources are the main consideration within religious contexts. While individuals may not regard their own religious texts as authoritative or factual, religion can shape their foundations or perspectives.

The Qur'an states:

“And indeed We created man from a quintessence of clay. Then We placed within him a small quantity of nutfa (sperm to fertilize) in a safe place. Then We have fashioned the nutfa into an ‘alaqa (clinging clot or cell cluster), then We developed the ‘alaqa into mudgha (a lump of flesh), and We made mudgha into bones, and clothed the bones with flesh, then We brought it into being as a new creation. So Blessed is Allah, the Best of Creators.” [52]

Many scholars of Islam estimate the time of soul installment, marked by the angel breathing in the soul to bring the individual into creation, as 120 days from conception. [53] Personhood begins at this point, and the value of life would prohibit research or experimentation that could harm the individual. If the fetus is more than 120 days old, the time ensoulment is interpreted to occur according to Islamic law, abortion is no longer permissible. [54] There are a few opposing opinions about early embryos in Islamic traditions. According to some Islamic theologians, there is no ensoulment of the early embryo, which is the source of stem cells for ESC research. [55]

In Buddhism, the stance on stem cell research is not settled. The main tenets, the prohibition against harming or destroying others (ahimsa) and the pursuit of knowledge (prajña) and compassion (karuna), leave Buddhist scholars and communities divided. [56] Some scholars argue stem cell research is in accordance with the Buddhist tenet of seeking knowledge and ending human suffering. Others feel it violates the principle of not harming others. Finding the balance between these two points relies on the karmic burden of Buddhist morality. In trying to prevent ahimsa towards the embryo, Buddhist scholars suggest that to comply with Buddhist tenets, research cannot be done as the embryo has personhood at the moment of conception and would reincarnate immediately, harming the individual's ability to build their karmic burden. [57] On the other hand, the Bodhisattvas, those considered to be on the path to enlightenment or Nirvana, have given organs and flesh to others to help alleviate grieving and to benefit all. [58] Acceptance varies on applied beliefs and interpretations.

Catholicism does not support embryonic stem cell research, as it entails creation or destruction of human embryos. This destruction conflicts with the belief in the sanctity of life. For example, in the Old Testament, Genesis describes humanity as being created in God’s image and multiplying on the Earth, referencing the sacred rights to human conception and the purpose of development and life. In the Ten Commandments, the tenet that one should not kill has numerous interpretations where killing could mean murder or shedding of the sanctity of life, demonstrating the high value of human personhood. In other books, the theological conception of when life begins is interpreted as in utero, [59] highlighting the inviolability of life and its formation in vivo to make a religious point for accepting such research as relatively limited, if at all. [60] The Vatican has released ethical directives to help apply a theological basis to modern-day conflicts. The Magisterium of the Church states that “unless there is a moral certainty of not causing harm,” experimentation on fetuses, fertilized cells, stem cells, or embryos constitutes a crime. [61] Such procedures would not respect the human person who exists at these stages, according to Catholicism. Damages to the embryo are considered gravely immoral and illicit. [62] Although the Catholic Church officially opposes abortion, surveys demonstrate that many Catholic people hold pro-choice views, whether due to the context of conception, stage of pregnancy, threat to the mother’s life, or for other reasons, demonstrating that practicing members can also accept some but not all tenets. [63]

Some major Jewish denominations, such as the Reform, Conservative, and Reconstructionist movements, are open to supporting ESC use or research as long as it is for saving a life. [64] Within Judaism, the Talmud, or study, gives personhood to the child at birth and emphasizes that life does not begin at conception: [65]

“If she is found pregnant, until the fortieth day it is mere fluid,” [66]

Whereas most religions prioritize the status of human embryos, the Halakah (Jewish religious law) states that to save one life, most other religious laws can be ignored because it is in pursuit of preservation. [67] Stem cell research is accepted due to application of these religious laws.

We recognize that all religions contain subsets and sects. The variety of environmental and cultural differences within religious groups requires further analysis to respect the flexibility of religious thoughts and practices. We make no presumptions that all cultures require notions of autonomy or morality as under the common morality theory , which asserts a set of universal moral norms that all individuals share provides moral reasoning and guides ethical decisions. [68] We only wish to show that the interaction with morality varies between cultures and countries.

III.     A Flexible Ethical Approach

The plurality of different moral approaches described above demonstrates that there can be no universally acceptable uniform law for ESC on a global scale. Instead of developing one standard, flexible ethical applications must be continued. We recommend local guidelines that incorporate important cultural and ethical priorities.

While the Declaration of Helsinki is more relevant to people in clinical trials receiving ESC products, in keeping with the tradition of protections for research subjects, consent of the donor is an ethical requirement for ESC donation in many jurisdictions including the US, Canada, and Europe. [69] The Declaration of Helsinki provides a reference point for regulatory standards and could potentially be used as a universal baseline for obtaining consent prior to gamete or embryo donation.

For instance, in Columbia University’s egg donor program for stem cell research, donors followed standard screening protocols and “underwent counseling sessions that included information as to the purpose of oocyte donation for research, what the oocytes would be used for, the risks and benefits of donation, and process of oocyte stimulation” to ensure transparency for consent. [70] The program helped advance stem cell research and provided clear and safe research methods with paid participants. Though paid participation or covering costs of incidental expenses may not be socially acceptable in every culture or context, [71] and creating embryos for ESC research is illegal in many jurisdictions, Columbia’s program was effective because of the clear and honest communications with donors, IRBs, and related stakeholders.  This example demonstrates that cultural acceptance of scientific research and of the idea that an egg or embryo does not have personhood is likely behind societal acceptance of donating eggs for ESC research. As noted, many countries do not permit the creation of embryos for research.

Proper communication and education regarding the process and purpose of stem cell research may bolster comprehension and garner more acceptance. “Given the sensitive subject material, a complete consent process can support voluntary participation through trust, understanding, and ethical norms from the cultures and morals participants value. This can be hard for researchers entering countries of different socioeconomic stability, with different languages and different societal values. [72]

An adequate moral foundation in medical ethics is derived from the cultural and religious basis that informs knowledge and actions. [73] Understanding local cultural and religious values and their impact on research could help researchers develop humility and promote inclusion.

IV.     Concerns

Some may argue that if researchers all adhere to one ethics standard, protection will be satisfied across all borders, and the global public will trust researchers. However, defining what needs to be protected and how to define such research standards is very specific to the people to which standards are applied. We suggest that applying one uniform guide cannot accurately protect each individual because we all possess our own perceptions and interpretations of social values. [74] Therefore, the issue of not adjusting to the moral pluralism between peoples in applying one standard of ethics can be resolved by building out ethics models that can be adapted to different cultures and religions.

Other concerns include medical tourism, which may promote health inequities. [75] Some countries may develop and approve products derived from ESC research before others, compromising research ethics or drug approval processes. There are also concerns about the sale of unauthorized stem cell treatments, for example, those without FDA approval in the United States. Countries with robust research infrastructures may be tempted to attract medical tourists, and some customers will have false hopes based on aggressive publicity of unproven treatments. [76]

For example, in China, stem cell clinics can market to foreign clients who are not protected under the regulatory regimes. Companies employ a marketing strategy of “ethically friendly” therapies. Specifically, in the case of Beike, China’s leading stem cell tourism company and sprouting network, ethical oversight of administrators or health bureaus at one site has “the unintended consequence of shifting questionable activities to another node in Beike's diffuse network.” [77] In contrast, Jordan is aware of stem cell research’s potential abuse and its own status as a “health-care hub.” Jordan’s expanded regulations include preserving the interests of individuals in clinical trials and banning private companies from ESC research to preserve transparency and the integrity of research practices. [78]

The social priorities of the community are also a concern. The ISSCR explicitly states that guidelines “should be periodically revised to accommodate scientific advances, new challenges, and evolving social priorities.” [79] The adaptable ethics model extends this consideration further by addressing whether research is warranted given the varying degrees of socioeconomic conditions, political stability, and healthcare accessibilities and limitations. An ethical approach would require discussion about resource allocation and appropriate distribution of funds. [80]

While some religions emphasize the sanctity of life from conception, which may lead to public opposition to ESC research, others encourage ESC research due to its potential for healing and alleviating human pain. Many countries have special regulations that balance local views on embryonic personhood, the benefits of research as individual or societal goods, and the protection of human research subjects. To foster understanding and constructive dialogue, global policy frameworks should prioritize the protection of universal human rights, transparency, and informed consent. In addition to these foundational global policies, we recommend tailoring local guidelines to reflect the diverse cultural and religious perspectives of the populations they govern. Ethics models should be adapted to local populations to effectively establish research protections, growth, and possibilities of stem cell research.

For example, in countries with strong beliefs in the moral sanctity of embryos or heavy religious restrictions, an adaptive model can allow for discussion instead of immediate rejection. In countries with limited individual rights and voice in science policy, an adaptive model ensures cultural, moral, and religious views are taken into consideration, thereby building social inclusion. While this ethical consideration by the government may not give a complete voice to every individual, it will help balance policies and maintain the diverse perspectives of those it affects. Embracing an adaptive ethics model of ESC research promotes open-minded dialogue and respect for the importance of human belief and tradition. By actively engaging with cultural and religious values, researchers can better handle disagreements and promote ethical research practices that benefit each society.

This brief exploration of the religious and cultural differences that impact ESC research reveals the nuances of relative ethics and highlights a need for local policymakers to apply a more intense adaptive model.

[1] Poliwoda, S., Noor, N., Downs, E., Schaaf, A., Cantwell, A., Ganti, L., Kaye, A. D., Mosel, L. I., Carroll, C. B., Viswanath, O., & Urits, I. (2022). Stem cells: a comprehensive review of origins and emerging clinical roles in medical practice.  Orthopedic reviews ,  14 (3), 37498. https://doi.org/10.52965/001c.37498

[2] Poliwoda, S., Noor, N., Downs, E., Schaaf, A., Cantwell, A., Ganti, L., Kaye, A. D., Mosel, L. I., Carroll, C. B., Viswanath, O., & Urits, I. (2022). Stem cells: a comprehensive review of origins and emerging clinical roles in medical practice.  Orthopedic reviews ,  14 (3), 37498. https://doi.org/10.52965/001c.37498

[3] International Society for Stem Cell Research. (2023). Laboratory-based human embryonic stem cell research, embryo research, and related research activities . International Society for Stem Cell Research. https://www.isscr.org/guidelines/blog-post-title-one-ed2td-6fcdk ; Kimmelman, J., Hyun, I., Benvenisty, N.  et al.  Policy: Global standards for stem-cell research.  Nature   533 , 311–313 (2016). https://doi.org/10.1038/533311a

[4] International Society for Stem Cell Research. (2023). Laboratory-based human embryonic stem cell research, embryo research, and related research activities . International Society for Stem Cell Research. https://www.isscr.org/guidelines/blog-post-title-one-ed2td-6fcdk

[5] Concerning the moral philosophies of stem cell research, our paper does not posit a personal moral stance nor delve into the “when” of human life begins. To read further about the philosophical debate, consider the following sources:

Sandel M. J. (2004). Embryo ethics--the moral logic of stem-cell research.  The New England journal of medicine ,  351 (3), 207–209. https://doi.org/10.1056/NEJMp048145 ; George, R. P., & Lee, P. (2020, September 26). Acorns and Embryos . The New Atlantis. https://www.thenewatlantis.com/publications/acorns-and-embryos ; Sagan, A., & Singer, P. (2007). The moral status of stem cells. Metaphilosophy , 38 (2/3), 264–284. http://www.jstor.org/stable/24439776 ; McHugh P. R. (2004). Zygote and "clonote"--the ethical use of embryonic stem cells.  The New England journal of medicine ,  351 (3), 209–211. https://doi.org/10.1056/NEJMp048147 ; Kurjak, A., & Tripalo, A. (2004). The facts and doubts about beginning of the human life and personality.  Bosnian journal of basic medical sciences ,  4 (1), 5–14. https://doi.org/10.17305/bjbms.2004.3453

[6] Vazin, T., & Freed, W. J. (2010). Human embryonic stem cells: derivation, culture, and differentiation: a review.  Restorative neurology and neuroscience ,  28 (4), 589–603. https://doi.org/10.3233/RNN-2010-0543

[7] Socially, at its core, the Western approach to ethics is widely principle-based, autonomy being one of the key factors to ensure a fundamental respect for persons within research. For information regarding autonomy in research, see: Department of Health, Education, and Welfare, & National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978). The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research.; For a more in-depth review of autonomy within the US, see: Beauchamp, T. L., & Childress, J. F. (1994). Principles of Biomedical Ethics . Oxford University Press.

[8] Sherley v. Sebelius , 644 F.3d 388 (D.C. Cir. 2011), citing 45 C.F.R. 46.204(b) and [42 U.S.C. § 289g(b)]. https://www.cadc.uscourts.gov/internet/opinions.nsf/6c690438a9b43dd685257a64004ebf99/$file/11-5241-1391178.pdf

[9] Stem Cell Research Enhancement Act of 2005, H. R. 810, 109 th Cong. (2001). https://www.govtrack.us/congress/bills/109/hr810/text ; Bush, G. W. (2006, July 19). Message to the House of Representatives . National Archives and Records Administration. https://georgewbush-whitehouse.archives.gov/news/releases/2006/07/20060719-5.html

[10] National Archives and Records Administration. (2009, March 9). Executive order 13505 -- removing barriers to responsible scientific research involving human stem cells . National Archives and Records Administration. https://obamawhitehouse.archives.gov/the-press-office/removing-barriers-responsible-scientific-research-involving-human-stem-cells

[11] Hurlbut, W. B. (2006). Science, Religion, and the Politics of Stem Cells.  Social Research ,  73 (3), 819–834. http://www.jstor.org/stable/40971854

[12] Akpa-Inyang, Francis & Chima, Sylvester. (2021). South African traditional values and beliefs regarding informed consent and limitations of the principle of respect for autonomy in African communities: a cross-cultural qualitative study. BMC Medical Ethics . 22. 10.1186/s12910-021-00678-4.

[13] Source for further reading: Tangwa G. B. (2007). Moral status of embryonic stem cells: perspective of an African villager. Bioethics , 21(8), 449–457. https://doi.org/10.1111/j.1467-8519.2007.00582.x , see also Mnisi, F. M. (2020). An African analysis based on ethics of Ubuntu - are human embryonic stem cell patents morally justifiable? African Insight , 49 (4).

[14] Jecker, N. S., & Atuire, C. (2021). Bioethics in Africa: A contextually enlightened analysis of three cases. Developing World Bioethics , 22 (2), 112–122. https://doi.org/10.1111/dewb.12324

[15] Jecker, N. S., & Atuire, C. (2021). Bioethics in Africa: A contextually enlightened analysis of three cases. Developing World Bioethics, 22(2), 112–122. https://doi.org/10.1111/dewb.12324

[16] Jackson, C.S., Pepper, M.S. Opportunities and barriers to establishing a cell therapy programme in South Africa.  Stem Cell Res Ther   4 , 54 (2013). https://doi.org/10.1186/scrt204 ; Pew Research Center. (2014, May 1). Public health a major priority in African nations . Pew Research Center’s Global Attitudes Project. https://www.pewresearch.org/global/2014/05/01/public-health-a-major-priority-in-african-nations/

[17] Department of Health Republic of South Africa. (2021). Health Research Priorities (revised) for South Africa 2021-2024 . National Health Research Strategy. https://www.health.gov.za/wp-content/uploads/2022/05/National-Health-Research-Priorities-2021-2024.pdf

[18] Oosthuizen, H. (2013). Legal and Ethical Issues in Stem Cell Research in South Africa. In: Beran, R. (eds) Legal and Forensic Medicine. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-32338-6_80 , see also: Gaobotse G (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[19] United States Bureau of Citizenship and Immigration Services. (1998). Tunisia: Information on the status of Christian conversions in Tunisia . UNHCR Web Archive. https://webarchive.archive.unhcr.org/20230522142618/https://www.refworld.org/docid/3df0be9a2.html

[20] Gaobotse, G. (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[21] Kooli, C. Review of assisted reproduction techniques, laws, and regulations in Muslim countries.  Middle East Fertil Soc J   24 , 8 (2020). https://doi.org/10.1186/s43043-019-0011-0 ; Gaobotse, G. (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[22] Pang M. C. (1999). Protective truthfulness: the Chinese way of safeguarding patients in informed treatment decisions. Journal of medical ethics , 25(3), 247–253. https://doi.org/10.1136/jme.25.3.247

[23] Wang, L., Wang, F., & Zhang, W. (2021). Bioethics in China’s biosecurity law: Forms, effects, and unsettled issues. Journal of law and the biosciences , 8(1).  https://doi.org/10.1093/jlb/lsab019 https://academic.oup.com/jlb/article/8/1/lsab019/6299199

[24] Wang, Y., Xue, Y., & Guo, H. D. (2022). Intervention effects of traditional Chinese medicine on stem cell therapy of myocardial infarction.  Frontiers in pharmacology ,  13 , 1013740. https://doi.org/10.3389/fphar.2022.1013740

[25] Li, X.-T., & Zhao, J. (2012). Chapter 4: An Approach to the Nature of Qi in TCM- Qi and Bioenergy. In Recent Advances in Theories and Practice of Chinese Medicine (p. 79). InTech.

[26] Luo, D., Xu, Z., Wang, Z., & Ran, W. (2021). China's Stem Cell Research and Knowledge Levels of Medical Practitioners and Students.  Stem cells international ,  2021 , 6667743. https://doi.org/10.1155/2021/6667743

[27] Luo, D., Xu, Z., Wang, Z., & Ran, W. (2021). China's Stem Cell Research and Knowledge Levels of Medical Practitioners and Students.  Stem cells international ,  2021 , 6667743. https://doi.org/10.1155/2021/6667743

[28] Zhang, J. Y. (2017). Lost in translation? accountability and governance of Clinical Stem Cell Research in China. Regenerative Medicine , 12 (6), 647–656. https://doi.org/10.2217/rme-2017-0035

[29] Wang, L., Wang, F., & Zhang, W. (2021). Bioethics in China’s biosecurity law: Forms, effects, and unsettled issues. Journal of law and the biosciences , 8(1).  https://doi.org/10.1093/jlb/lsab019 https://academic.oup.com/jlb/article/8/1/lsab019/6299199

[30] Chen, H., Wei, T., Wang, H.  et al.  Association of China’s two-child policy with changes in number of births and birth defects rate, 2008–2017.  BMC Public Health   22 , 434 (2022). https://doi.org/10.1186/s12889-022-12839-0

[31] Azuma, K. Regulatory Landscape of Regenerative Medicine in Japan.  Curr Stem Cell Rep   1 , 118–128 (2015). https://doi.org/10.1007/s40778-015-0012-6

[32] Harris, R. (2005, May 19). Researchers Report Advance in Stem Cell Production . NPR. https://www.npr.org/2005/05/19/4658967/researchers-report-advance-in-stem-cell-production

[33] Park, S. (2012). South Korea steps up stem-cell work.  Nature . https://doi.org/10.1038/nature.2012.10565

[34] Resnik, D. B., Shamoo, A. E., & Krimsky, S. (2006). Fraudulent human embryonic stem cell research in South Korea: lessons learned.  Accountability in research ,  13 (1), 101–109. https://doi.org/10.1080/08989620600634193 .

[35] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6

[36] Association for the Advancement of Blood and Biotherapies.  https://www.aabb.org/regulatory-and-advocacy/regulatory-affairs/regulatory-for-cellular-therapies/international-competent-authorities/saudi-arabia

[37] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia.  BMC medical ethics ,  21 (1), 35. https://doi.org/10.1186/s12910-020-00482-6

[38] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia. BMC medical ethics , 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6

Culturally, autonomy practices follow a relational autonomy approach based on a paternalistic deontological health care model. The adherence to strict international research policies and religious pillars within the regulatory environment is a great foundation for research ethics. However, there is a need to develop locally targeted ethics approaches for research (as called for in Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6), this decision-making approach may help advise a research decision model. For more on the clinical cultural autonomy approaches, see: Alabdullah, Y. Y., Alzaid, E., Alsaad, S., Alamri, T., Alolayan, S. W., Bah, S., & Aljoudi, A. S. (2022). Autonomy and paternalism in Shared decision‐making in a Saudi Arabian tertiary hospital: A cross‐sectional study. Developing World Bioethics , 23 (3), 260–268. https://doi.org/10.1111/dewb.12355 ; Bukhari, A. A. (2017). Universal Principles of Bioethics and Patient Rights in Saudi Arabia (Doctoral dissertation, Duquesne University). https://dsc.duq.edu/etd/124; Ladha, S., Nakshawani, S. A., Alzaidy, A., & Tarab, B. (2023, October 26). Islam and Bioethics: What We All Need to Know . Columbia University School of Professional Studies. https://sps.columbia.edu/events/islam-and-bioethics-what-we-all-need-know

[39] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics.  Research Ethics ,  17 (2), 228-241.  https://doi.org/10.1177/1747016120966779

[40] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics.  Research Ethics ,  17 (2), 228-241.  https://doi.org/10.1177/1747016120966779

[41] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

[42] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

[43] The EU’s definition of autonomy relates to the capacity for creating ideas, moral insight, decisions, and actions without constraint, personal responsibility, and informed consent. However, the EU views autonomy as not completely able to protect individuals and depends on other principles, such as dignity, which “expresses the intrinsic worth and fundamental equality of all human beings.” Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3

[44] Council of Europe. Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No. 164) https://www.coe.int/en/web/conventions/full-list?module=treaty-detail&treatynum=164 (forbidding the creation of embryos for research purposes only, and suggests embryos in vitro have protections.); Also see Drabiak-Syed B. K. (2013). New President, New Human Embryonic Stem Cell Research Policy: Comparative International Perspectives and Embryonic Stem Cell Research Laws in France.  Biotechnology Law Report ,  32 (6), 349–356. https://doi.org/10.1089/blr.2013.9865

[45] Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3

[46] Tomuschat, C., Currie, D. P., Kommers, D. P., & Kerr, R. (Trans.). (1949, May 23). Basic law for the Federal Republic of Germany. https://www.btg-bestellservice.de/pdf/80201000.pdf

[47] Regulation of Stem Cell Research in Germany . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-germany

[48] Regulation of Stem Cell Research in Finland . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-finland

[49] Regulation of Stem Cell Research in Spain . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-spain

[50] Some sources to consider regarding ethics models or regulatory oversights of other cultures not covered:

Kara MA. Applicability of the principle of respect for autonomy: the perspective of Turkey. J Med Ethics. 2007 Nov;33(11):627-30. doi: 10.1136/jme.2006.017400. PMID: 17971462; PMCID: PMC2598110.

Ugarte, O. N., & Acioly, M. A. (2014). The principle of autonomy in Brazil: one needs to discuss it ...  Revista do Colegio Brasileiro de Cirurgioes ,  41 (5), 374–377. https://doi.org/10.1590/0100-69912014005013

Bharadwaj, A., & Glasner, P. E. (2012). Local cells, global science: The rise of embryonic stem cell research in India . Routledge.

For further research on specific European countries regarding ethical and regulatory framework, we recommend this database: Regulation of Stem Cell Research in Europe . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-europe   

[51] Klitzman, R. (2006). Complications of culture in obtaining informed consent. The American Journal of Bioethics, 6(1), 20–21. https://doi.org/10.1080/15265160500394671 see also: Ekmekci, P. E., & Arda, B. (2017). Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights.  Cultura (Iasi, Romania) ,  14 (2), 159–172.; For why trust is important in research, see also: Gray, B., Hilder, J., Macdonald, L., Tester, R., Dowell, A., & Stubbe, M. (2017). Are research ethics guidelines culturally competent?  Research Ethics ,  13 (1), 23-41.  https://doi.org/10.1177/1747016116650235

[52] The Qur'an  (M. Khattab, Trans.). (1965). Al-Mu’minun, 23: 12-14. https://quran.com/23

[53] Lenfest, Y. (2017, December 8). Islam and the beginning of human life . Bill of Health. https://blog.petrieflom.law.harvard.edu/2017/12/08/islam-and-the-beginning-of-human-life/

[54] Aksoy, S. (2005). Making regulations and drawing up legislation in Islamic countries under conditions of uncertainty, with special reference to embryonic stem cell research. Journal of Medical Ethics , 31: 399-403.; see also: Mahmoud, Azza. "Islamic Bioethics: National Regulations and Guidelines of Human Stem Cell Research in the Muslim World." Master's thesis, Chapman University, 2022. https://doi.org/10.36837/ chapman.000386

[55] Rashid, R. (2022). When does Ensoulment occur in the Human Foetus. Journal of the British Islamic Medical Association , 12 (4). ISSN 2634 8071. https://www.jbima.com/wp-content/uploads/2023/01/2-Ethics-3_-Ensoulment_Rafaqat.pdf.

[56] Sivaraman, M. & Noor, S. (2017). Ethics of embryonic stem cell research according to Buddhist, Hindu, Catholic, and Islamic religions: perspective from Malaysia. Asian Biomedicine,8(1) 43-52.  https://doi.org/10.5372/1905-7415.0801.260

[57] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[58] Lecso, P. A. (1991). The Bodhisattva Ideal and Organ Transplantation.  Journal of Religion and Health ,  30 (1), 35–41. http://www.jstor.org/stable/27510629 ; Bodhisattva, S. (n.d.). The Key of Becoming a Bodhisattva . A Guide to the Bodhisattva Way of Life. http://www.buddhism.org/Sutras/2/BodhisattvaWay.htm

[59] There is no explicit religious reference to when life begins or how to conduct research that interacts with the concept of life. However, these are relevant verses pertaining to how the fetus is viewed. (( King James Bible . (1999). Oxford University Press. (original work published 1769))

Jerimiah 1: 5 “Before I formed thee in the belly I knew thee; and before thou camest forth out of the womb I sanctified thee…”

In prophet Jerimiah’s insight, God set him apart as a person known before childbirth, a theme carried within the Psalm of David.

Psalm 139: 13-14 “…Thou hast covered me in my mother's womb. I will praise thee; for I am fearfully and wonderfully made…”

These verses demonstrate David’s respect for God as an entity that would know of all man’s thoughts and doings even before birth.

[60] It should be noted that abortion is not supported as well.

[61] The Vatican. (1987, February 22). Instruction on Respect for Human Life in Its Origin and on the Dignity of Procreation Replies to Certain Questions of the Day . Congregation For the Doctrine of the Faith. https://www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_19870222_respect-for-human-life_en.html

[62] The Vatican. (2000, August 25). Declaration On the Production and the Scientific and Therapeutic Use of Human Embryonic Stem Cells . Pontifical Academy for Life. https://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_20000824_cellule-staminali_en.html ; Ohara, N. (2003). Ethical Consideration of Experimentation Using Living Human Embryos: The Catholic Church’s Position on Human Embryonic Stem Cell Research and Human Cloning. Department of Obstetrics and Gynecology . Retrieved from https://article.imrpress.com/journal/CEOG/30/2-3/pii/2003018/77-81.pdf.

[63] Smith, G. A. (2022, May 23). Like Americans overall, Catholics vary in their abortion views, with regular mass attenders most opposed . Pew Research Center. https://www.pewresearch.org/short-reads/2022/05/23/like-americans-overall-catholics-vary-in-their-abortion-views-with-regular-mass-attenders-most-opposed/

[64] Rosner, F., & Reichman, E. (2002). Embryonic stem cell research in Jewish law. Journal of halacha and contemporary society , (43), 49–68.; Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[65] Schenker J. G. (2008). The beginning of human life: status of embryo. Perspectives in Halakha (Jewish Religious Law).  Journal of assisted reproduction and genetics ,  25 (6), 271–276. https://doi.org/10.1007/s10815-008-9221-6

[66] Ruttenberg, D. (2020, May 5). The Torah of Abortion Justice (annotated source sheet) . Sefaria. https://www.sefaria.org/sheets/234926.7?lang=bi&with=all&lang2=en

[67] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[68] Gert, B. (2007). Common morality: Deciding what to do . Oxford Univ. Press.

[69] World Medical Association (2013). World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA , 310(20), 2191–2194. https://doi.org/10.1001/jama.2013.281053 Declaration of Helsinki – WMA – The World Medical Association .; see also: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979).  The Belmont report: Ethical principles and guidelines for the protection of human subjects of research . U.S. Department of Health and Human Services.  https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

[70] Zakarin Safier, L., Gumer, A., Kline, M., Egli, D., & Sauer, M. V. (2018). Compensating human subjects providing oocytes for stem cell research: 9-year experience and outcomes.  Journal of assisted reproduction and genetics ,  35 (7), 1219–1225. https://doi.org/10.1007/s10815-018-1171-z https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6063839/ see also: Riordan, N. H., & Paz Rodríguez, J. (2021). Addressing concerns regarding associated costs, transparency, and integrity of research in recent stem cell trial. Stem Cells Translational Medicine , 10 (12), 1715–1716. https://doi.org/10.1002/sctm.21-0234

[71] Klitzman, R., & Sauer, M. V. (2009). Payment of egg donors in stem cell research in the USA.  Reproductive biomedicine online ,  18 (5), 603–608. https://doi.org/10.1016/s1472-6483(10)60002-8

[72] Krosin, M. T., Klitzman, R., Levin, B., Cheng, J., & Ranney, M. L. (2006). Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa.  Clinical trials (London, England) ,  3 (3), 306–313. https://doi.org/10.1191/1740774506cn150oa

[73] Veatch, Robert M.  Hippocratic, Religious, and Secular Medical Ethics: The Points of Conflict . Georgetown University Press, 2012.

[74] Msoroka, M. S., & Amundsen, D. (2018). One size fits not quite all: Universal research ethics with diversity.  Research Ethics ,  14 (3), 1-17.  https://doi.org/10.1177/1747016117739939

[75] Pirzada, N. (2022). The Expansion of Turkey’s Medical Tourism Industry.  Voices in Bioethics ,  8 . https://doi.org/10.52214/vib.v8i.9894

[76] Stem Cell Tourism: False Hope for Real Money . Harvard Stem Cell Institute (HSCI). (2023). https://hsci.harvard.edu/stem-cell-tourism , See also: Bissassar, M. (2017). Transnational Stem Cell Tourism: An ethical analysis.  Voices in Bioethics ,  3 . https://doi.org/10.7916/vib.v3i.6027

[77] Song, P. (2011) The proliferation of stem cell therapies in post-Mao China: problematizing ethical regulation,  New Genetics and Society , 30:2, 141-153, DOI:  10.1080/14636778.2011.574375

[78] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

[79] International Society for Stem Cell Research. (2024). Standards in stem cell research . International Society for Stem Cell Research. https://www.isscr.org/guidelines/5-standards-in-stem-cell-research

[80] Benjamin, R. (2013). People’s science bodies and rights on the Stem Cell Frontier . Stanford University Press.

Olivia Bowers

MS Bioethics Columbia University (Disclosure: affiliated with Voices in Bioethics)

Mifrah Hayath

SM Candidate Harvard Medical School, MS Biotechnology Johns Hopkins University

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What’s the Matter with Business Ethics?

• Andrew Stark

It’s not that managers dislike the idea of doing the right thing …

With the recent boom in business ethics comes a curious irony: the more entrenched the discipline becomes in business schools, the more bewildering—and even off-putting—it appears to actual managers.

• AS Andrew Stark is assistant professor in the Faculty of Management at the University of Toronto and research associate at the university’s Centre for Corporate Social Performance and Ethics.

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• Open access
• Published: 16 May 2024

Refusal of patients: care for people without health insurance in German emergency departments

• Matthias Zimmer   ORCID: orcid.org/0000-0002-6148-5748 1  

BMC Medical Ethics volume  25 , Article number:  56 ( 2024 ) Cite this article

Metrics details

In case of an emergency, health insurance in Germany provides easy access to medical care in emergency departments. Over 100,000 people do not have health insurance for various reasons. They are repeatedly refused treatment in emergency rooms as their right to care outside of regular insurance is often unknown or ignored.

Peer Review reports

German social law prescribes that every resident of the German state must have a health insurance. [Insurance Contract Act]. This insurance, which is provided either through statutory health insurance or private health insurance, offers general access to the healthcare system. This also includes the treatment of emergencies such as life-threatening illnesses, major injuries or severe pain. Emergency patients should be treated in emergency departments, which are used by 19 million patients every year [ 1 ]. In addition to critically ill patients, patients who are less seriously ill are also treated in the emergency departments [ 1 ]. Less seriously ill patients should be cared by the general practitioners, but many patients don’t want to accept this [ 2 ]. Due to acute emergency presentations, workload compression, and working hours, emergency department staff may experience stress regarding their mental and somatic health [ 2 ]. In this area of conflict, people without health insurance pose a particular challenge because familiar administrative procedures and medical matters are questioned.

According to the 2019 Microcensus, 61,000 people in Germany were reported to have no health insurance [ 3 ]. The number of unreported cases is probably much higher, estimated minimum 100,000 [ 4 , 5 ], as the microcensus is a sample-based survey aimed at people with a permanent residence and a regular registration address [ 6 , 7 ]. German language skills are also required to answer the questions. As a result, many people such as the homeless, migrants, people in precarious living situations etc. are not or not sufficiently covered. People of all ages are uninsured, tending to be younger than 50 years and have reduced health literacy [ 8 , 9 , 10 ]. Patients without health insurance cannot fulfill their obligation to have insurance because, among other things, they lack the financial means, their living situation is not described by the law, they are employed illegally or there are delays in the allocation of health insurance or equivalent state benefits. Anyone who does not have health insurance in Germany must pay for all medical services and use their own personal financial resources. But people without health insurance do not have the financial resources to pay for medical services, otherwise they would be able to afford health insurance [ 5 , 8 ]. As a result, the need to maintain or restore one’s own health is not fulfilled.

In a few cities, people without health insurance can consult a charitable institution for medical care (Malteser Medizin für Menschen ohne Krankenversicherung, Ärzte der Welt, MediNetz). These alternative doctors’ offices don’t provide round-the-clock care and can’t take care of life-threatening emergencies. In principle, equipment at charitable institutions can rarely be compared with regular doctors’ offices. In emergency situations, uninsured or apparently uninsured patients find themselves in a dilemma. After all, alternative doctors’ offices are unable to care for them and, at the same time, charitable institutions report that these patients repeatedly experience refusals in emergency rooms.

This article results of intensive literature research based on the author’s professional experience as the director of an emergency department. The area of conflict between the economic and legal aspects of providing care to people without health insurance is highlighted. From this, possibilities are developed to find ways out of current dilemma.

Economic aspects

In the German healthcare system, hospitals are managed similarly to commercial companies.

They are owned by the public sector (28.5%), non-profit companies (31.6%) and private companies (39.9%) such as limited companies, Societas Europaea or joint-stock companies [ 10 ]. In contrast to state or non-profit hospitals, private hospitals are highly profit-oriented companies. Returns can be up to 15% [ 11 ] Insured patients receive free health care in all hospitals, because health insurance cover medical costs. Patients with statutory health insurance have an insurance card with a smart card that identifies them as insured. Privately insured patients either have an insurance card or must provide their insurance details verbally to hospital administration.

In any case of medical care, uninsured patients generate the risk of a doubtful or irrecoverable debt in the respective annual balance sheet for the hospital. These missing earnings are not taken into account in the existing reimbursement system of diagnosis-related groups (DRG) [ 12 ]. For the period from 2011 to 2014, Mylinus showed that the annual uncovered costs of caring for uninsured migrants amounted up to 1.100.000 euros per hospital [ 13 ]. The type of ownership did not play a role here. In this context an individual physician, who is an employee of a company, cannot escape the economic pressure that has arisen in the healthcare system [ 14 ].

Legal considerations

The Basic Law of the Federal Republic of Germany provides guidelines for social action under the Dictum of Human Dignity, Article 1 of the Basic Law [ 15 ]. The protection of dignity is also incumbent on physicians according to Sect. 7 of the Medical Professional Code [ 16 ]. To respect this and physical integrity [Article 2 of the Basic Law], it is an indispensable medical task to provide an indication for diagnosis or therapy [ 15 ]. The prerogative to make such decisions is based on a social contract [ 17 ], which places a high level of responsibility on the medical profession [ 16 ]. The advised curative intervention itself requires appropriate information derived from Section 630e of the German Civil Code [ 16 , 18 ].

Legal framework requires direct contact between physicians and patients in Germany. Physicians are not the first contact for patients in emergency departments for organizational reasons, but rather administrative staff or nursing staff [ 19 ]. They could already refuse uninsured patients and not let them see a physician. The charitable organization Malteser Medizin für Menschen ohne Krankenversicherung (Malteser Medicine for People without Health Insurance) has gained corresponding experience with refused patients (Management meeting Malteser Medizin für Menschen ohne Krankenversicherung 01–02 June 2023, personal communication). A refusal without a physician’s involvement seems problematic from a legal point of view.

Physicians may refuse to treat a patient if there is no medical emergency (Sect. 7, Subsection 2 of the Professional Code of Conduct) [ 16 ]. In addition a physician can refuse treatment if there is no danger to life or severe pain and the patient is unable to pay for treatment [ 16 ].

However, in case of refusal by physicians further legal pitfalls must be considered. Hospital laws of the German federal states of Hesse [ 20 ] and Schleswig-Holstein [ 21 ] also stipulate that medically indicated treatment must be carried out regardless of the patient’s financial ability. Furthermore, requirements for failure to render assistance (Section 323c, German Criminal Code) should not be met [ 22 ]. This means not providing assistance in an emergency, even though it is necessary and can reasonably be expected [ 22 ]. The absence of an emergency is essential. However, bodily harm and manslaughter could also occur in conjunction with the legal concept of acting by omission if treatment is refused (Sects. 13, 212 and 223, German Criminal Code) [ 22 ]. As early as 1966, the German Federal Supreme Court ruled in a similar direction, holding physicians responsible for providing the best possible assistance within the scope of their abilities [ 23 ].

From a legal perspective, the refusal of a patient is associated with high hurdles and must be well justified. Only absence or apparent absence of health insurance is not a sufficient reason for a refusal.

Legal situation of apparently uninsured patients

Patients who are apparently not covered by health insurance form a heterogeneous group consisting of homeless people, EU citizens, non-EU citizens, asylum seekers, war refugees and people with illegal residence status. Their legal rights differ significantly.

Homeless German citizens

According to Social Code XII, social assistance offices (Sect. 3, Subsection 1, Twelfth Social Code) have to pay for healthcare (Sects. 47 to 52, Twelfth Social Code) for homeless people [ 24 ]. Depending on whether short-term help or longer-term help is required, the social assistance offices either cover the medical costs directly or indirectly via a health insurance fund as an intermediary (Sect. 98, Subsections 1 and 2, Twelfth Social Code) [ 24 ]. Physicians should have no concerns when treating homeless Germans, as medical costs are covered by social assistance offices.

European union [EU]/ European economic community citizens [EEC]

For uninsured EU citizens and citizens of the EEC states regulations apply, in accordance with the Freedom of Movement Act/EU [ 25 ]. The European Court of Justice recently took the German government to task on this point [ 26 ] to provide assistance in case of illness, pregnancy, and maternity to non-German citizens who were actually residing in Germany (cf. Section 23, Twelfth Social Code) [ 24 ]. Again, responsible authorities are the social assistance offices. Social assistance is subordinate to other sources of benefits under Subsection 1 of Sect. 2, Twelfth Social Code [ 24 ], thus patients or hospitals must provide relevant evidence. The benefits are also not to be granted if the non-German citizens are not employees/self-employed persons, are in the first three months of their stay, are primarily looking for work, do not have a residence permit, have entered only for the purpose of receiving social assistance or are family members of the abovementioned individuals. According to Sect. 23, Subsection 3, Twelfth Social Code, people who do not have the right of residence in Germany can be granted a bridging allowance until they leave the country, at the longest for one month within two years [ 24 ]. This was recently confirmed by the 8th Senate of the Federal Social Court in summer 2023 [ 27 ]. Physicians in German emergency rooms should receive regular legal updates in addition to continuing medical education, as insurance law is constantly changing.

Non-EU citizens

Non-EU citizens with a residence permit, according to the Residence Act [ 28 ], but without health insurance, come under the purview of Sect. 23, Twelfth Social Code in the same way as EU citizens [ 24 ]. According to Sect. 23 Twelfth Social Code, local social assistance offices must provide bridging assistance [ 24 ]. However, proof must be provided that no other sources of benefits exist in the sense of the subordination of social assistance pursuant to Sect. 2, Subsection 1, Twelfth Social Code [ 24 ]. It is difficult to imagine that hospitals have the capability to check sources of benefits of their patients. The implementation of state-financed clearing houses would be one way of relieving hospitals. Only very few clearing houses currently exist in Germany.

Asylum seekers

People receiving benefits under the Asylum Seekers Benefits Act receive care for acute illness, pain conditions, and pregnancy, under Sect. 4 of the Residence Act [ 28 , 29 ]. Even in the case of deportation healthcare is made possible within the framework of bridging benefits under Sect. 1, Subsection 4 of the Residence Act [ 28 ]. Depending on the federal state, the people concerned receive a health insurance card or apply for a treatment voucher from the concerned social assistance offices for each medical consultation. In the case of an acute emergency treatment certificate can also be applied for subsequently. Asylum seekers who have been in Germany for more than 18 months receive benefits under Sect. 2 of the Residence Act, analogous to those received by assistance recipients under Sects. 47–52 of the Twelfth Social Code [ 24 , 28 ] Physicians should know that asylum seeker status could provide coverage for medical costs.

War refugees

War refugees who arrive in the EU and, subsequently, in Germany as a result of a mass influx identified by the Council of the EU are granted a temporary right of residence [ 30 ]. Local social welfare authorities primarily assume the costs and subsequently pass them on to the federal government under Sect. 24, Residence Act [ 28 ]. The so-called “friction certificate,” which is issued by the local immigration authorities serves as proof. However, the temporary right of residence begins with the fulfillment of the criterion of seeking protection. The request for healthcare is already such a request for protection.

People with illegal residence status

People who have crossed the German borders without an official residence permit (illegal residence status) can’t work legally and can’t take out health insurance. In the case of legal employment, registration with a health insurance is required. Again, health insurances are obliged to report their knowledge of a missing residence permit to immigration authorities. As a result, people with illegal residence would receive a fine or prison sentence and be deported from Germany [ 28 ]. If people with illegal residence and without health insurance come to an emergency department, it is possible that physicians refuse patients. Some physicians believe that they are liable to prosecution if they provide medical care to people with illegal residence status [ 31 ]. This assessment is clearly wrong according to §§ 95 and 96 of the Residence Act [ 28 ]. The German Federal Ministry of the Interior confirmed this in 2007 [ 32 ].

In principle, people living illegally can also receive emergency health benefits under Sect. 4 of the Asylum Seekers Benefits Act in conjunction with Sect. 48 of the Twelfth Social Code [ 24 , 29 ]. However, because of the subordination of social assistance [Sect. 2, Subsection 1, Twelfth Social Code], it is difficult for the people concerned or the hospital to prove that they are in need [ 24 ]. Given the lack of documents in most cases of people living illegally, the required proof is difficult to maintain and is considered laborious by the hospital administrations [ 31 ]. In addition, major uncertainties exist regarding the transfer of data from hospitals to social assistance offices. This is because according to Sect. 87, Subsection 2 number 2a, Residence Act, public authorities have to inform immigration authorities if they become aware of people without a valid residence permit [ 28 ]. However, in the case of data originating from the doctor-patient relationship [see Sect. 203, Subsection 1 numbers 1, 2, 4, and 6, and Subsection 3, German Criminal Code], this should be prevented by the so-called “extended protection of secrets” [ 22 , 33 ]. As this is only an administrative regulation and not a law, federal states interpret the regulations differently in some cases [ 31 ]. Therefore, any application for assistance could lead to a report to the immigration authorities. Emergency department staff should know what special protection applies to people with illegal residence status when it comes to health care. And they should know that the costs of emergency care are covered by the social assistance office.

Hurdles in the administrative law

If a hospital wants to be paid for services rendered in retrospect (based on Sect. 4, Asylum Seekers’ Benefits Act in conjunction with Sect. 48, Twelfth Social Code) in the absence of a voucher for treatment, substantial entitlements are imposed on it [ 24 , 29 ]. The hospital must immediately ask the social welfare agency by application whether the costs can be covered. If the authority cannot be reached, for example at night, the application must be submitted immediately on the next working day. Otherwise, the hospital’s claims expire.

Medical ethos

The current multidimensional demands on physicians are enormous. Physicians should decide wisely [ 34 ]. The health of their patients should be the highest priority of their actions [ 35 ]. And they should work to safeguard or restore patient rights if these are violated [ 36 ].

In light of the economic pressure on the German healthcare system, physicians’ behavior should not be subordinated to optimizing the economic benefit of the hospital [ 37 ]. Simultaneously, physicians must bow to government-mandated business requirements. In sum, physicians also have expectations from themselves and their profession. Conflicting goals such as ethos versus framework conditions reduce physicians’ intrinsic motivation and, thus, their enjoyment of their work [ 38 , 39 ]. Especially young physicians do not want to support primary monetary subordination of their actions [ 40 ]. If individual physicians try to combine all the abovementioned points as much as possible in their thinking and actions, they will carry a heavy burden due to high expectations. If hospital administrators rely on the rejection of patients when they are unable to pay for their treatment, physicians will face an ethical dilemma in conjunction with an enormous conflict of loyalty. This dilemma is exacerbated by the fact that younger physicians in the emergency departments are bound by instructions.

Conclusions

The issue of people without health insurance comprises highly complex legal aspects. In some cases, there is only an apparent lack of health insurance and people really have various claims for cost coverage by the social assistance office. However, the actual insurance status can hardly be clarified ad hoc.

From a legal point of view, in Germany it is up to the physicians to decide whether the hospital may refuse a patient or not. A refusal must be made in accordance with the applicable law and should also include ethical considerations. In any case, a vital threat and consequential damage to the patient must be ruled out. Continuous legal training for physicians appears to make sense. Physicians receive rarely any legal teaching during their studies and specialist training, although their work is accompanied by numerous legal regulations. This creates uncertainty in decision-making. Directors of emergency departments and hospital administrations should define processes in accordance with medical ethics and legal situation in order to care for uninsured patients and clarify their true insurance status. This also includes the fact that the rejection of patients is a purely medical task that cannot be delegated to non-medical staff.

At the same time, legal hurdles should be reduced to make it easier to enforce existing legal entitlements to health care. Time requirements for hospitals to claim reimbursement should be made more flexible. In addition, defined reporting channels to the authorities would also be helpful in order to avoid delays in processing and loss of information. Implementation of state-financed clearing houses to clarify insurance claims could be helpful for apparently uninsured patients. Treatment funds could also be set up by the federal states to provide unbureaucratic health care in emergency situations. However, a reform of general hospital funding could also ensure that the financial pressure on physicians in their decision-making is reduced. All of these points can only be realized through social debate and political decision-making in parliaments.

Data availability

No datasets were generated or analysed during the current study.

Regierungskommission für eine moderne und bedarfsgerechte Krankenhausversorgung. Vierte Stellungnahme Und Empfehlung: Reform Der Notfall- Und Akutversorgung in Deutschland Integrierte Notfallzentren Und Integrierte Leitstellen. Berlin: Federal Ministry of Health; 2023.

Google Scholar  

Shanafelt TD, Boone S, Tan L, Dyrbye LN, Sotile W, Satele D, et al. Burnout and satisfaction with work-life balance among US physicians relative to the general US population. Arch Intern Med. 2012. https://doi.org/10.1001/archinternmed.2012.3199 .

Article   Google Scholar  

Statistisches Bundesamt. Fachserie 13 Reihe 1.1 Sozialleistungen: Angaben Zur Krankenversicherung [Ergebnisse Des Mikrozensus] 2019. Wiesbaden: German Federal Statistical Office; 2020. p. 42.

Greß S, Walendzik A, Wasem J. Auswirkungen Der Regelungen Des GKV-Wettbewerbsstärkungsgesetzes auf Nichtversicherung Im Deutschen Krankenversicherungssystem. Essen/Fulda: Hans-Böckler-Stiftung; 2008.

Sahm A, Zimmer M. Gute Versorgung Älterer parallel Zur Klinik? Strukturelle Hürden in Der Versorgung Von Menschen Ohne Krankenversicherung. In: Fewer A, Klotz S, Müller S, Sahm A, editors. Jahrbuch Ethik in Der Klinik 2022. Erlangen: Königshausen & Neumann; 2022. pp. 179–204.

Bundesamt S. Qualitätsbericht. Wiesbaden: German Federal Statistical Office; 2019. p. 7.

Neupert I. Menschen Ohne Krankenversicherung Im Gesundheitswesen: explorative studie zur Prävalenz Und Zur Rückführung. Die sozialen Sicherungssysteme durch den Sozialdienst am Beispiel Des Universitätsklinikums Essen. Essen: Universität Duisburg-Essen; 2018. pp. 30–6.

Fietzek M. Patienten Ohne Krankenversicherungsschutz in Deutschland – Bericht Aus Der Sprechstunde Der Malteser Migranten Medizin [MMM] in Stuttgart. Z Med Eth. 2018. https://doi.org/10.14623/zfme.2018.1.65-72 .

Schaeffer D, Berens EM, Gille S, Griese L, Klinger J, de Sombre S, Vogt D. Hurrelmann. Gesundheitskompetenz Der Bevölkerung in Deutschland Vor Und während Der Corona Pandemie: Ergebnisse Des HLS-GER 2. Bielefeld: Universität Bielefeld; 2021.

Statistisches Bundesamt. https://www.destatis.de/DE/Themen/Gesellschaft-Umwelt/Gesundheit/Krankenhaeuser/Tabellen/eckzahlen-krankenhaeuser.html . Accessed 26 Dec 2023.

Stüwe H. Private Klinikträger: die Großen Erzielen Gute Gewinne. Dtsch Arztebl. 2015;23:A–1056.

Gesetz zur wirtschaftlichen. Sicherung der Krankenhäuser und zur Regelung der Krankenhauspflegesätze 1972, last modified 2023.

Mylius M. Krankenhausaufenthalte Von Migrantinnen und Migranten Ohne Krankenversicherung: Eine explorative Studie Zur stationären Versorgung in Niedersachsen. Berlin Und Hamburg Gesundheitswesen. 2016;78:203–8. https://doi.org/10.1055/s-0042-102342 .

Central Ethics Comittee of Federal Medical Association. Versorgung Von Nicht regulär krankenversicherten Patienten Mit Migrationshintergrund. Dtsch Arztebl. 2013;18:899–903.

Basic Law of. the Federal Republic of Germany 1949, last modified 2022.

Federal Medical Association. [Muster-]Berufsordnung für die in Deutschland tätigen Ärztinnen Und Ärzte: MBO-Ä 1997 in Der Fassung Des Beschlusses Des 124. Deutschen Ärztetages Vom 5. Mai 2021 in Berlin. Berlin: Bundesärztekammer; 2021.

Williams JR. Handbuch Der ärztlichen Ethik. Frankreich, the World Medical Association, Ethics Unit. Axbridge, World Health Communication Associates; 2005.

German C. Code 1896, last modified 2023.

Schellein O, Ludwig-Pistor F, Bremerich DH. Manchester triage system. Process optimization in the interdisciplinary emergency department. Anaesthesist. 2009;2:163–70.

Zweites. Gesetz zur Weiterentwicklung des Krankenhauswesens in Hessen 2011.

Krankenhausgesetz für das Land Schleswig-Holstein.

German C. Code 1871, last modified 2023.

Alois H. Aus L. v Landgericht Landshut [1966] 1 StR 567/65 [Bundesgerichtshof].

Twelfth Social Code. 2003, last modified 2023.

Freedom of Movement Act/EU. 2004, last modified 2023.

Jobcenter Krefeld – Widerspruchsstelle v JD [2020] Az. C-181/19 [Court of Justice of the European Union].

Universitätsklinikum. Aachen v Stadt Aachen [2023] B 8 SO 11/22 R [Bundessozialgericht].

Residence A. 2008, last modified 2023.

Asylum Seekers. Benefits Act 1997, last modified 2022.

Council Directive 2001/55/EC of 20. July 2001 on minimum standards for giving temporary protection in the event of a mass influx of displaced persons and on measures promoting a balance of efforts between Member States in receiving such persons and bearing the consequences thereof OJ L 212 [2001].

Fallsammlung der Bundesarbeitsgruppe Gesundheit/Illegalität. Krank und ohne Papiere. Berlin: Diakonie Deutschland; 2018. pp. 3–15.

Bundesministerium des Innern. Illegal aufhältige Migranten in Deutschland. Datenlage, Rechtslage, Handlungsoptionen. Bericht Zum Prüfauftrag „Illegalität Aus Der Koalitionsvereinbarung Vom 11. November 2005, Kapitel VIII 1.2. Berlin: Bundesministerium des Innern; 2007.

Allgemeine. Verwaltungsvorschrift zum Aufenthaltsgesetz [2009].

Deutsche Gesellschaft für Innere Medizin e. V. Sammelband 2021. Berlin: Deutscher Ärzte; 2021. WEISE ENTSCHEIDEN.

World Medical Association. Declaration of Geneva: adopted by the 2nd General Assembly of the World Medical Association, last and amended by the 68th WMA General Assembly. World Medical Association; 2017.

World Medical Association. Declaration of Lisbon on the Rights of the Patient: adopted by the 34th World Medical Assembly, last reaffirmed by the 200th WMA Council Session. 2015.

Deutsche Gesellschaft für Innere Medizin e. V. Rückhalt für ärztliches Handeln. Dtsch Arztebl. 2017;49:2338–40.

Kehr HM, Strasser M. Motivierende Mitarbeiterführung - Gezielt motivieren mit dem 3K-Modell. In: Haering K, Litzke S, editors. Führungskompetenz lerne. Stuttgart: Schaeffer-Poeschel; 2013. pp. 267–87.

Sokolowski K, Kehr HM. Zum Differentiellen Einfluß Von Motiven auf die Wirkung Von Führungstrainings. ZDDP. 1999;20:192–202.

Junge Ärztinnen und Ärzte wollen sich nicht der Macht des Geldes unterordnen. 2023. https://www.aerzteblatt.de/nachrichten/134455/Junge-Aerztinnen-und-Aerzte-wollen-sich-nicht-der-Macht-des-Geldes-unterordnen . Accessed 08 Aug 2023.

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The author thanks Malteser Medicine for People without Health Insurance, Germany for their reports of experience and insight into their work.

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Ethics review finds probable cause that Rep. Troy Nehls misused campaign funds

FILE - Rep. Troy Nehls, R-Texas, is pictured during a news conference on Capitol Hill, Feb. 1, 2023, in Washington. The independent office that reviews allegations against House members has found probable cause that Nehls converted campaign funds to personal use. The finding and a 6-0 recommendation to investigate further was contained in a new disclosure revealed Friday, May 10, 2024, to meet public disclosure requirements. But leaders of the committee emphasized that the disclosure does not itself indicate that any violation has occurred, and the investigation is ongoing. (AP Photo/Jess Rapfogel, File)

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WASHINGTON (AP) — The independent office that reviews allegations against House members found probable cause that Rep. Troy Nehls of Texas converted campaign funds to personal use, triggering an investigation by the House Ethics Committee, a new disclosure revealed Friday.

The recommendation and the full report from the Office of Congressional Ethics were both released Friday, as required under the law. The leaders of the House Ethics Committee emphasized that the disclosure does not itself mean that a violation has occurred and stressed that the investigation into Nehls is ongoing. Nehls’ lawyer told the committee the lawmaker did not profit from the arrangement that had raised red flags with the ethics office.

Nehls, a second-term Republican lawmaker, was a county sheriff for eight years before serving in the House. He’s a staunch Donald Trump supporter who attended this year’s State of the Union address wearing a T-shirt decorated with Trump’s mugshot.

The Office of Congressional Ethics recommended the committee investigation in December by a vote of 6-0.

The office sought to determine whether Nehls’ campaign paid a company registered to the congressman for reasons other than legitimate campaign purposes.

The ethics office said Nehls’ campaign committee made more than $25,000 in rental payments since late 2019 to an entity known as Liberty 1776, LLC, and that a review of state records shows that he was the registered agent for the company.

The report notes that campaigns cannot spend money for “personal use,” and that prohibition includes the purchase or lease of services from the member himself. The office said Nehls declined to cooperate with its investigation and due to that lack of cooperation, no witnesses could confirm that the payments made to Liberty 1776 were for legitimate campaign purposes.

The report also stated that Nehls did not disclose any income derived from Liberty 1776 on his financial disclosure forms required for members and candidates.

An attorney representing Nehls disputed the lack of cooperation with the Office of Congressional Ethics. Rather, counsel objected to ambiguously worded requests for information. And the Office of Congressional Ethics never responded to clarify the review’s scope, he said.

Further, the attorney, Jared Najvar, said that Nehls and several other candidates agreed they should pursue a particular property in Richmond, Texas, as a location for a campaign headquarters and associated activities. He said there was an oral contract in which Liberty 1776 would pay rent and make certain improvements to the property. He said Liberty 1776 took in about $52,872 and expended that amount on the property.

“The various rent payments by Nehls for Congress to Liberty 1776 from 2019 through 2022 were, therefore, legitimate rent payments for campaign office use,” Najvar wrote to the Ethics Committee in a January letter.

The attorney also said Nehls’ financial disclosure form would be amended to include his affiliation with Liberty 1776 and that failure to include it was an oversight brought to the congressman’s attention by the OCE’s referral.

The Office of Congressional Ethics is often the first to review alleged violations of the law or House rules, but it’s the 10 lawmakers on the House Ethics Committee that make a final determination of whether violations occurred. Nehls has said he will cooperate with the House panel’s investigation.

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Ethics Committees: Structure, Roles, and Issues

Pankti mehta.

1 Department of Clinical Immunology and Rheumatology, King George’s Medical University, Lucknow, India.

Olena Zimba

2 Department of Clinical Rheumatology and Immunology, University Hospital in Krakow, Krakow, Poland.

3 National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland.

4 Department of Internal Medicine N2, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.

Armen Yuri Gasparyan

5 Departments of Rheumatology and Research and Development, Dudley Group NHS Foundation Trust (Teaching Trust of the University of Birmingham, UK), Russells Hall Hospital, Dudley, UK.

Birzhan Seiil

6 Department of Biology and Biochemistry, South Kazakhstan Medical Academy, Shymkent, Kazakhstan.

Marlen Yessirkepov

An Ethics Committee (EC) is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects based on six basic principles of autonomy, justice, beneficence, nonmaleficence, confidentiality, and honesty. MEDLINE, Scopus, and Directory of Open Access Journals were searched for studies relevant to this topic. This review is focused on the types of research articles that need EC approval, the submission process, and exemptions. It further highlights the constitution of ECs, their duties, the review process, and the assessment of the risk-benefit of the proposed research including privacy issues. It’s pertinent for academicians and researchers to abide by the rules and regulations put forth by ECs for upholding of human rights and protecting research subjects primarily, as well as avoiding other issues like retraction of publications. Despite various issues of cost, backlogs, lack of expertise, lesser representation of laypersons, need for multiple approvals for multisite projects, conflicts of interest, and monitoring of ongoing research for the continued safety of participants, the ECs form the central force in regulating research and participant safety. Data safety and monitoring boards complement the ECs for carrying out continuous monitoring for better protection of research subjects. The establishment of ECs has ensured safe study designs, the safety of human subjects along with the protection of researchers from before the initiation until the completion of a study.

Graphical Abstract

INTRODUCTION

The journey of the role of ethics in biomedical research began with “The Doctor’s Trial” post-World War II in which 23 doctors and administrators were tried for war crimes, crimes against humanity, and conducting research without informed consent. This judgment, known as the “Nuremberg Code” was one of the first international ethical standards which gave a ten-point rule with respect to the protection of human research participants. The core principle was the requirement of voluntary consent of human subjects and respecting human autonomy. 1 , 2

However, some researchers continued to ignore the code and violations like the Willow Brook Hepatitis Study (1956), Jewish Chronic Disease Study (1963), and 22 others were highlighted by Beecher in 1966. 3 , 4 This led to the composition of the Declaration of Helsinki by the World Medical Association in Finland in 1964 with revisions at regular intervals. 5 This affirmed the principles highlighted in the Nuremberg Code stating that research should be conducted upholding the interests and rights of the human subjects. It proposed for the first time, the submission of a research protocol to an ethics committee (EC) before the initiation of the study ( Fig. 1 ). 6

EC refers to “Committees established by professional societies, health facilities, or other institutions to consider decisions that have bioethical implications. The role of these committees may include consultation, education, mediation, and/or review of policies and practices.” Committees that consider the ethical dimensions of patient care are Clinical ECs whereas committees established to protect the welfare of research subjects are Research ECs. 7 In this review, we will be using the terms ECs and Research ECs interchangeably.

It was in the 1960s that most nations developed guidelines regarding the formation of ECs with the main task of protection of human subjects. 8 EC is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects. ECs can be of two types—Institutional Review Boards (IRBs) or Institutional ECs (IECs) (referred to IRB or IEC by different countries) that are formally constituted by an institution to review research projects for that institute. An independent EC is an autonomous EC that is not part of any institute and performs the same functions independently. It is helpful for institutes that don’t have an IRB.

Despite these regulations, the unethical standards of the Tuskegee Syphilis study emerged in 1972 in which treatment was denied to the participants in order to study the natural course of the disease. This was followed by the conversion of the National Research Act in the USA into law (1974) and the setting up of the national commission of ‘International Ethical Guidelines for Biomedical Research Involving Human Subjects’ that submitted the Belmont report in 1979. The Belmont report described the role of assessment of risk-benefit of research involving human subjects, appropriate guidelines for selection of human subjects, and definition of informed consent. It was based on the three pillars of ethics- respect, beneficence, and justice. 9 , 10 It stressed the need for the approval of studies by an EC in accordance with the 1975 revision of the World Medical Association in Tokyo. Subsequently, countries like China, India, and South Korea adopted and legalized the need for submission of protocols to ECs from the 1980s onwards. 11 , 12 , 13 , 14

ECs function on six basic principles 15 :

• 1. Autonomy: respect the patient’s right to act on his/her own value and choice.
• 2. Justice: fair treatment of the research subjects.
• 3. Beneficence: work for the benefit of the patient.
• 4. Nonmaleficence: primum non-nocere or first do no harm to the patient.
• 5. Confidentiality: privacy protection.
• 6. Honesty: truthfulness in terms of the study.

Ethics approval is required for most research studies to uphold the above-mentioned principles, and protect the participants as well as the researcher. 16

In this narrative review, we aim to study the structure and function of ECs or IRBs with a focus on the composition, role, violations, and development perspectives of ECs.

Searches through MEDLINE (PubMed) and Scopus were performed in line with previously published recommendations. 17

Articles published till March 15, 2023 were reviewed using the following keywords: ("Ethics Committees, Clinical/classification"[Mesh] OR "Ethics Committees, Clinical/economics"[Mesh] OR "Ethics Committees, Clinical/ethics"[Mesh] OR "Ethics Committees, Clinical/history"[Mesh] OR "Ethics Committees, Clinical/legislation and jurisprudence"[Mesh] OR "Ethics Committees, Clinical/organization AND administration"[Mesh] OR "Ethics Committees, Clinical/standards"[Mesh] OR "Ethics Committees, Clinical/statistics and numerical data"[Mesh] OR "Ethics Committees, Clinical/trends"[Mesh]). Additional searches about subtopics were also carried out (“Data Safety Monitoring Boards” OR “Independent Data Review Committees”, “Institutional Review Boards” OR “Ethics Committees” and “Problems” OR “Issues”).

Articles in languages other than English, and reviews, conference proceedings, and editorials were excluded. Relevant articles searchable at the Directory of Open Access Journals and references of included articles were also processed for eligibility and inclusion for this narrative review. 18 , 19 , 20 , 21

RESEARCH, SUBMISSION PROCESS, AND EXEMPTIONS

IRB approval is required for most research to protect human rights and assess the scientific soundness of the research. For this, we first need to understand what research is. Research is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” ( Table 1 ). 8

IRB = Institutional Review Board.

An EC approval is required for studies with more than minimal risk to the subjects where the intention is to publish findings or contribute to the scientific knowledge, studies involving the compilation or analysis of data containing patient identifying information, studies with any risk of physical or mental discomfort to participants or their families, and studies on vulnerable groups. 22 Minimal risk refers to the probability of discomfort posed by the research is not greater than that ordinarily encountered in routine daily life activities of an average healthy individual. 5 , 8 , 22

Thus, even surveys and archived data that contain patient identifying information (name, age, address) and sensitive information (illicit drug use, comorbidities, communicable diseases, e.g., HIV AIDS) need ethical approval to uphold the privacy and anonymity of the participants as well as protection the possibility of psychological discomfort to them. 10 , 23 , 24 , 25

Some studies may be exempted from ethical approval including most educational research, case reports on one to three patients (without any hypothesis testing), those that pose no risk to the participants, involve information freely available in the open domain for the community, analysis of open-source datasets or anonymized datasets obtained from other researchers with due informed consent taken at the time of primary data collection, research evaluating the public health programs or government public schemes. 26 , 27 However, a formal exemption is to be decided by the IRB and not the investigator. 8 , 28

For projects requiring an EC approval, the type of reviews includes expedited and a full board review. Expedited review is for research involving no more than minimal risk to the subjects, minor revisions of an already approved study, and is usually conducted by an experienced person or the chair of the IRB. A full board review on the other hand is for research with greater than minimal risk to the subjects or those involving vulnerable populations. This is reviewed extensively by a full IRB meeting.

The documents usually required for a full ethics review include the name of the applicant with designation, approval of the head of the department, research/trial protocol, ethical issues if any, and plans to address them, written informed consent form (and assent forms) in the language the participant understands, data collection tools, patient information sheet, regulatory clearances (e.g., Drug Controller General of India in India for drug trials), finance and funding details, Insurance, statement of conflicts of interest, information about payment or compensation to the subjects, scientific or departmental review board permission, Curriculum Vitae of the investigators, declaration of interests and any other relevant information. 29 , 30 Waivers of consent may be provided for no more than minimal risk to the subjects when the waiver will not endanger the rights and welfare of the subjects like retrospective studies, secondary analysis of data wherein consent had been taken previously, use of open access databases with anonymized data, and emergency research as seen fit by the EC. 31 , 32 In emergencies like the coronavirus disease 2019 pandemic, waivers may be provided if the patient is incapacitated or in life-threatening situations where there is no time for informed consent. Pandemics like these may even call for common documents for risk disclosure and audio/video/electronic consent. 33 , 34

EC PERSONNEL, THEIR EXPERIENCE, AND DUTIES

ECs have the primary responsibility of reviewing research and its alignment with the Good Clinical Practice (GCP) guidelines. 35 The research design must be scientifically sound and conducted in an ethical way to include human subjects with voluntary informed consent.

The composition of ECs varies depending on the country, center, volume, and nature of the research reviewed. However, there are some basic recommendations laid down by national authorities and GCP. 30

• a) Most countries in Europe, the USA, and South Korea have a requirement of at least five members whereas recommendations in China and India need a minimum of seven members and a maximum of 12–15 members. 14 , 36 , 37 , 38 , 39
• b) At least one member who is autonomous, independent of the institution or trial site. It is mandatory that the chairperson of the EC is not part of the institution where the research is to be conducted.

Others include a member secretary from within the institution and members from the scientific field. The composition should have an adequate gender and age representation with a blend of basic scientists, clinician scientists, one legal expert, one social scientist, one philosopher, and one layperson. Review of research involving vulnerable populations like children, pregnant women, handicapped, prisoners, etc., must involve one member with expertise in dealing with that population. 40 , 41 It is also desirable to have a member or expert advisor for special areas of research who has proficiency in that field.

Responsibilities

The chairperson has the primary responsibility of independent and smooth functioning of the EC, ensuring the participation of all members, seeking Conflict of Interests from all members, and handling complaints against the researchers and EC members. 39 It’s the responsibility of the member secretary to schedule EC meetings, handle documentation, organize an effective review of proposals, define and maintain adherence to standard operating procedures (SOPs), train EC members, and assess the need for expedited reviews/exemption from review. 39 The members of the scientific community have the primary responsibility of reviewing the research protocols and their scientific soundness. The non-scientist member is crucial to safeguard the human subjects and practical issues of the research. 40 , 41 However, studies have shown lesser participation by laypersons as compared to scientific members. A study conducted across 10 academic centers across the USA with 20 IRB meetings recorded noted that 29 community members were present in 17 of those meetings. They were primary reviewers in only two of the 93 submitted protocols due to refusal on grounds of lack of knowledge regarding medical research. Even as secondary and tertiary reviewers, they were less active and were more likely to focus on issues related to confidentiality. However, they played a greater role when they were not designated reviewers. 42

The EC or IRBs function to review and approve research protocols, monitor ongoing research involving human subjects with the aims of continual protection of human volunteers, advancement of research, and protecting the institute from litigation. Its main role is the protection of the human rights, autonomy, confidentiality, and welfare of the research subjects especially vulnerable populations. The GCP recommends the following for duties of the IRB ( Table 2 , Fig. 3 ) 35 :

e.g., An immunosuppressive drug “X” being evaluated for patients with Lupus Nephritis.

IRB = Institutional Review Board, SOC = standard of care, GCP = Good Clinical Practice, MMF = mycophenolate mofetil, CYC = cyclophosphamide, ICU = intensive care unit, SOP = standard operating procedure, RCT = randomized controlled trial.

• • The IRB should obtain and review all the necessary documents for the research/trial within a reasonable time and document its views following standardized operating procedures with clear identification of the dates for approval, modifications, disapproval, or termination of an ongoing trial that was initially approved in writing.
• • Qualification of the investigators should be considered for the proposed research.
• • Reviewing of ongoing research as appropriate to the risks involved (at least once a year).
• • Protocols indicating exemption of prior consent of the subject or their legally acceptable representative (e.g., emergency situations) should be assessed in detail for all the regulatory needs.
• • Review the sum and method of compensatory payment to subjects if required.
• • Functions should be performed as per written SOPs which should comply with the GCP guideline.

Most IRBs conduct meetings regularly (one–two per month depending on the number of protocols) and SOPs are followed as per the national governing authority.

An EC review is a continuous process and is needed before the initiation of research, before the extension of the approval period, prior to modifications to an already approved study, for monitoring of any adverse events, and until all the data collection and analysis is complete. 8 An oversight to the monitoring of trials (usually single center, early phase, less risky) is provided by the IRBs through annual reviews, adverse event monitoring, and reporting of undue events by the principal investigator (PI). However, complex clinical trials and/or multicenter, randomized controlled trials, interventional studies with pre-existing concerns about safety, or study participants who might need additional protection through an additional committee referred to as the Data Safety Monitoring Board (DSMB). 43 , 44

RISKS, BENEFITS, CONFIDENTIALITY, AND PRIVACY ISSUES IN RESEARCH PROTOCOLS

The role of the EC is not only to provide direct protection to human subjects from physical or mental harm but also to weigh the risks and benefits involved in the research. It must be assessed if the study is designed to add to the current scientific knowledge base and help society. 8

The research protocol is the document that includes the research question, aims and objectives, a critical literature review, methodology, and statistical plan. It is pertinent that the IRB reviews the protocol with respect to the clarity and focus of the research question; and whether the study design is suitable to answer the same. This is decided by the chair or a special departmental committee ( Table 2 , Fig. 3 ).

Privacy and confidentiality are a part and parcel of every physician-patient relationship. Needless to say, this must be maintained in a researcher-human subject relationship as well. It helps build trust, curbs participant anxiety, maintains their dignity, and above all their autonomy. 10 The International Committee of Medical Journal Editors recommends that authors must ensure that nonessential information like names, initials hospital record numbers, etc., are omitted during data collection, storage, and publication whenever possible. 45 However, there’s an extent to which this confidentiality can be maintained. Information required for scientific purposes (e.g., clinical photographs) or those with mandated legal reporting may breach participant privacy. This needs to be explained to the participant and recorded in written informed consent ( Table 2 ).

The role of the IRB with respect to privacy and confidentiality is to:

• • Review the consent document and assess the sensitivity of the information, the duration for which it will be held, the usefulness of the information, and the ability to protect it.
• • For multicenter projects, review the measures taken by the research team to maintain the privacy of the research subjects including the number of personnel with access to the information, data storage, and transfer.
• • An ongoing review of the research must include monitoring of confidentiality issues to check for maintenance of the same and the need for a revised privacy protection plan.
• • Educate researchers and IRB members regarding the data privacy and protection process. 46

Review of informed consent by IRBs is especially important in low-middle-income countries. There are various issues related to the lack of understanding of the information provided, maintaining privacy due to interference by family members, and the inability to assess risk and benefit by the research participant. IRBs have an additional responsibility to ensure that studies have minimal/no risk to the participant, the consent forms are clear and simple to understand and ensure the proper process of obtaining informed consent is being followed without undue pressure or coercion to participate in the study. 47

VIOLATIONS OF ETHICS APPROVAL RULES AND REGULATIONS

Violations of IRB approval rules like lack of approval, lack of approval of modifications to the protocol, and lack of informed consent can result in dire aftermaths for the authors. It can result in the withdrawal of the article if it’s still in press, retraction if it’s already published, and even removal if it has legal consequences. The number of papers retracted as searched on the retraction database 48 is steadily increasing by the decade from 474 in the 1990s to 6120 in the 2010s. The most common reason for retraction is plagiarism whereas violation of IRB rules accounts for 4–5% of all retractions. 49 , 50 When consultations for ethical inquiries to the Korean Association of Medical Journal Editor were analyzed, the most common reason was duplicate publications (12 of 80) with issues with IRB approval (5 of 80) and informed consent (6 of 80). 51 Some of the examples of types of studies and their reasons for retractions have been summarized in Table 3 .

Violations can be assessed before the studies are published for those with IRB approval. It is the responsibility of the IRBs to monitor whether ongoing studies are abiding by the ethical regulations and whether the approved protocol is being followed. A study conducted in India by an IRB at a tertiary care hospital in Mumbai monitored 12 clinical trials from 2011–2017. The most common violations were related to informed consent, followed by a lack of understanding of protocol and protocol deviations. This was corrected by re-taking of the informed consent and retraining in GCP by the IRB. 52 A similar study in Uganda done from 2007–2010 with monitoring of 40 research projects also found a similar frequency and reasons for violations. 53

Journal editors routinely check if a statement mentioning whether ethics approval was sought has been mentioned in the manuscript. Depending on the journal and type of article, further details of the EC approval can be sought by the journal editorial board. 54

ISSUES AND ONGOING DEVELOPMENTS

ECs were developed to provide ethical oversight to clinical research. But here are various issues associated with the functioning of IRBs.

• • Composition: Most studies indicate a skewed gender representation in the structure IRBs. Further, the participation of laypersons on the board is minimal. 14 , 42 , 55 , 56 , 57
• • Overburdened IRBs, delays, and operational costs: The IRB reviews have been associated with delays from over 4 to 7 months on average from surveys conducted across the USA. 58 , 59 A delay in biomedical research can translate into more than monetary loss as biomedical research saves lives and a delay in the approvals can result in greater loss of life. 60 An older survey conducted across 63 institutions (with 20 being low volume, 24 intermediate volume, and 19 being high volume centers) in the USA in 2005 reported the median amount spent by academic medical centers on IRB was $750,000/year with an average of $559 per review. The main costs are divided across staff salary, board salary, space, outsourcing of the reviews, travel, supplies, and equipment. 61 Over the years, there is a definite increase in the number of ongoing research projects thus increasing these costs further. Furthermore, documentation of Food and Drug Administration (FDA) warning letters to IRBs was predominantly related to paperwork stressing on documentation of reviews and meetings rather than ethical issues. 62 Increasing paperwork further results in delays and added costs. These deficiencies are more marked in developing nations like India and China dealing with issues like lack of regulation, informal ethics reviews, lack of supervision, and insufficient ethics review capacity. 63 , 64
• • Multi-site projects: With multicenter projects on the rise, a single protocol is often reviewed by multiple IRBs. In a review of 17 articles reported from UK, USA and Europe, which underwent multiple IRB reviews of the same protocol there were discrepancies in the judgment. Five of 26 reported rejection at some and acceptance by some IRBs. However, there were great differences in the protocol revisions, consent, patient information sheets, risk-benefit assessment, and compensation arrangements. 65 Keeping these issues in mind, the Common Rule in the USA was revised in 2017 with IRB approval required only from one center for multisite projects. 66 This may be extrapolated to other nations or consideration of an expedited review at other sites when fully reviewed at one IRB can be considered.
• • Independent EC and IEC: Independent ECs have inherent tissues of limitation of knowledge about the local community and use of these may promote IRB shopping. Whereas, local IRBs can have conflicts of interest as colleagues of investigators may be on the review board. Thus, a central IRB can alleviate some of these concerns by avoiding repetitive reviews, minimizing conflicts, and establishing a centralized adverse event reporting system. 67 , 68 , 69 A central IRB can be formed by experts on a particular subject or by a group of institutes like the National Cancer Institute’s Central IRB and the Biomedical Research Alliance of New York respectively. 70 , 71
• • Scientific expertise of the IRB reviewers: The IRB reviewers may lack the scientific expertise to review sophisticated research projects that may affect the quality of the research. 11 , 14 , 57 , 72 Regular training in research ethics and GCP along with adequate consultations with external experts is needed. This can be done at a national, regional, and international level. First, by identifying core issues and then solutions for them by focused training. 73 Training of EC members is conducted across Central Asia and Eastern Europe under the framework of Forum for Ethics Committees in the Confederation of Independent States and Strategic Initiative for Developing Capacity in Ethical Review program that train members regarding GCP, bioethics, the establishment of an EC, review processes and SOPs, choosing independent consultants, and confidentiality agreements. 74
• • Review of studies involving complementary and integrative medicine (CIM) is a challenge due to the lack of quality evidence to support the basis for their use. Moreover, most international regulatory bodies and research regulations do not address CIM, thus leaving the review process and decision-making to the IRBs. However, it is to be emphasized here studies irrespective of the type (modern or CIM) must be reviewed using the same principles of respect, beneficence, and justice. Well-designed studies on CIM are essential to ascertain the health and safety of patients. 75

DSMB is defined by the FDA, USA as “a group of individuals with pertinent scientific expertise that review research data of an ongoing trial on a regular basis, advises the sponsor/or researcher regarding the continuing safety of research subjects and those yet to be recruited into the research trial, and advises as to the continuing validity and scientific merit of the trial.” 76 It’s an autonomous entity independent of the researchers, sponsors, and the IRB so as to control data sharing and protect the authenticity of the clinical trial from unfavorable impact. 35 It was first developed in the USA in the 1960s as the NIH began sponsoring multicenter trials, the first trial was the Coronary Drug Project which used a DSMB for monitoring. 77 Over time, it became a common practice for the sponsors to have experienced scientific personnel serving on these committees. Although the FDA does not mandate DSMB for all trials, DSMBs are generally recommended for large, multi-site studies evaluating treatments that intend to reduce mortality and morbidity.

DSMBs are usually constituted for:

• • The study outcome is such that a highly encouraging or detrimental result is a possibility in an interim analysis that may require an early termination of the study on ethical grounds.
• • When the safety concerns are high, e.g., invasive therapy is administered.
• • Previous data suggesting serious toxicity with the study treatment.
• • Studies involving vulnerable populations.
• • Studies including subjects at an increased risk of death or serious outcomes.
• • Large, multisite, long-duration studies.

In India, it is recommended by the Indian GCP guidelines that the sponsor may establish a DSMB to assess the progress of the trial, and in 2006 Indian Council of Medical Research (ICMR) mandated a DSMB to review data emerging from research on interventions in the emergency setting. 39 These were updated in 2012 by the ICMR to include all stem cell research involving human subjects. The SOPs for the constitution and responsibilities of the DSMB are laid down by the World Health Organization and are similar across USA, Europe, and South Korea. 78 , 79

DSMBs are constituted by scientific members and are appointed by the funding agency, before the recruitment of the first subject in the trial. It can consist of as few as three members and is typically constituted of clinicians and at least one biostatistician. Others that may be included are medical ethicists, other scientists, etc. The most important requisite is that the members should be independent of the sponsors, investigators IRBs, regulatory authorities, and site or study staff. They should have no conflicts of interest with the sponsors, researchers, or study staff.

The functions of the DSMB are:

• • To uphold participant safety.
• • Ensure credibility and integrity of the trial for future subjects.
• • Ensure the timely conclusion of the study so that the results can be disseminated.
• • Identify protocol violations if any.
• • Identify unexpectedly high dropouts and evaluate for the same.
• • Ensure the validity of the results.

The above functions are carried out by an initial organizational meeting to understand the protocol and safety monitoring plan followed by an early safety review meeting to review early safety information. Continuing periodic reviews to assess safety, efficacy, and the progress of the trial are then carried out with reporting of serious adverse events. 44 A final meeting is to be held at the termination of a study. DSMBs function independently of the IRBS but the PIs must submit DSMB reports or minutes to the IRB.

Dramatic instances in which trials have been stopped prematurely on the recommendation of the DSMB include the withdrawal of rofecoxib and celecoxib in two trials on the prevention of colonic polyps due to increased cardiovascular events. 80 , 81

We have come a long way from the horrific ethical compromises in clinical studies in history to establishing adequate safety for the human subjects participating in clinical research today. The establishment of the IRB or EC has ensured safe study designs and the safety of human subjects right from before the study initiation until its completion. This is further supplanted by additional boards like DSMBs. However, we still need studies assessing the outcomes of the ECs on a global basis and addressing various issues that are still pertinent to the working of the ECs. 82

Disclosures: The authors have no potential conflicts of interest to disclose.

Author Contributions:

• Conceptualization: Mehta P, Zimba O, Gasparyan AY, Seiil B, Yessirkepov M.
• Data curation: Mehta P.
• Writing - original draft: Mehta P.
• Writing - review & editing: Mehta P, Zimba O, Gasparyan AY, Seiil B, Yessirkepov M.

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Georgia appeals court will review decision that allowed Fani Willis to stay on Trump's Fulton County case

By Melissa Quinn

Updated on: May 8, 2024 / 10:46 AM EDT / CBS News

Washington — The Georgia Court of Appeals on Wednesday agreed to review a decision by a Fulton County Superior Court judge who declined to disqualify District Attorney Fani Willis and her office from the 2020 election case against former President Donald Trump because of a personal relationship Willis had with a prosecutor.

Steve Sadow, Trump's lawyer in the Fulton County case, said on social media that the court granted Trump's appeal of Judge Scott McAfee's decision to allow Willis to continue leading the prosecution.  McAfee's ruling, though, required Nathan Wade, then a special prosecutor who was romantically involved with Willis, to withdraw from the case. Wade resigned in the wake of McAfee's decision.

The Georgia Court of Appeals issued a brief order granting Trump's request that it take up his appeal. It's unclear when arguments will be held.

"President Trump looks forward to presenting interlocutory arguments to the Georgia Court of Appeals as to why the case should be dismissed and Fulton County DA Willis should be disqualified for her misconduct in this unjustified, unwarranted political persecution," Sadow said in a statement.

The district attorney's office declined to comment.

The Fulton County case

Trump and more than a dozen of his allies were charged in a sprawling racketeering case brought by Willis last year, which accuses them of engaging in an unlawful scheme to overturn the results of the 2020 election in Georgia. The former president and the 18 co-defendants charged alongside him all pleaded not guilty. Four later accepted plea deals .

The case was derailed after one of those co-defendants, Michael Roman, accused Willis and Wade in January of having an improper romantic relationship that began before Wade was hired to work on the election case in November 2021. Roman, a longtime GOP operative, claimed that Willis financially benefited from the relationship, since Wade allegedly paid for trips, hotel rooms and travel expenses using money he received through his work as a special prosecutor.

Trump, Roman and seven others sought to have Willis and her office removed from the case and the charges against them dismissed.

Wade and Willis both acknowledged they were romantically involved, but disputed claims that their relationship began before Wade's hiring. Both took the stand during an evidentiary hearing in February, where Willis forcefully defended herself from allegations of wrongdoing. The two testified that they split the costs associated with their travels, and Willis said she often reimbursed Wade in cash for her share. 

McAfee issued a highly anticipated ruling in March that rejected the effort to have Willis and her office kicked off the case as long as Wade stepped aside, which allowed the prosecution to move forward. But the judge was scathing in his decision and chastised Willis for what he said was a "tremendous lapse in judgement." 

McAfee said that while he could not conclusively establish when Wade and Willis' relationship became romantic, "an odor of mendacity remains." Following his decision, the judge allowed Trump and the eight others to seek review of his ruling from the Georgia Court of Appeals. But McAfee said then that he intended to continue addressing unrelated pretrial matters.

The defendants  submitted a formal application to appeal McAfee's decision in March, and the appeals court had 45 days to decide whether to take up the matter. Trump could ask the Georgia Court of Appeals to pause proceedings while it considers the disqualification issue.

The court's decision to grant Trump's appeal will likely delay the start of any trial, though no date has been set for it to begin. The case in Fulton County is one of four Trump is facing as he mounts a third bid for the White House. His first  criminal trial is currently underway in Manhattan, where local prosecutors charged him with 34 counts of falsifying business records. He pleaded not guilty to those charges.

Two other cases were brought by special counsel Jack Smith in federal courts in Washington, D.C., and South Florida. The D.C. case involves an alleged effort to subvert the transfer of presidential power after the 2020 election, and the Florida case involves Trump's alleged mishandling of sensitive government records after leaving the White House.

The former president pleaded not guilty to the federal charges he faces, and trials in each of those cases have been indefinitely postponed .  

The developments in Fulton County mean it's increasingly unlikely that the three outstanding trials will be held before the November presidential election. Trump, the presumptive Republican presidential nominee, is set to face-off against President Biden in a rematch of the 2020 contest.

Jared Eggleston and Nikole Killion contributed to this report

Melissa Quinn is a politics reporter for CBSNews.com. She has written for outlets including the Washington Examiner, Daily Signal and Alexandria Times. Melissa covers U.S. politics, with a focus on the Supreme Court and federal courts.

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