Medical Research Ethics

كان يمشي في الأرض مرحًا، مُصعرًا خده للطبيعة، ومُنتشيًا برفاهيات حضاراته؛ أو يخطو فوق أديمها مهمومًا بضنك العيش، يعتصره ألم البحث عن قوت يومه، قبل أن يُفاجئه الفيروس التاجي ليقلب حياته رأسًا على عقب. إنه الإنسان، ذلك المجهول لنفسه، الجاهل بعلمه، المغرور بعقله، الضعيف بقوته، المتناقض مع ذاته، الفقير بثرواته الضخمة! فجأة باتت تعتمل بداخله مشاعر الحيرة والخوف والقلق، تؤرقه تساؤلات تسخر من عجزه الصارخ عن الإجابة عنها: ما أصل هذا الفيروس؟ هل هو نبتٌ طبيعي أم مؤامرة من بني جلدته؟ (...) ما هو أفضل علاج لمكافحته؟ لماذا يحصد الأرواح غير مًبالٍ؟ وكيف يمكن لكائن متناه في الصغر، غير مرئي، أن يشن حربًا ضد البشر بكل هذه القوة في القرن الحادي والعشرين، ورغم كل ما تحقق من تقدمٍ علمي وطبي مذهل؟ يعجز العلم عن الإجابة، ويعجز الساسة عن التبرير، ويعجز الدعاة عن المواساة، ويعجز العائل عن حماية رعيته، وينكفئ المرء على نفسه باحثًا عن الإجابات في منطقةٍ فكرية مُهملة: الفلسفة! أجل، فتساؤلات الجائحة تُشبه كثيرًا تلك المنطقة الحدودية التي حدثنا عنها الفيلسوف الألماني «كارل ياسبرز»، والتي لا يمكن أن نتجاوزها بالطرقة العلمية والتجريبية، عندها يُواجه المرء خيارين لا ثالث لهما: إما أن يستسلم لأمواج اليأس العاتية، أو يتوضأ من أنهار الحكمة التي تناساها ردحًا طويلاً من الزمن! لا شك أن ثمة نظريات عديدة عن أصل الفيروس: بعضهم يعتقد أنه مُنتج بشري تم تخليقه في المختبرات لاستخدامه كسلاح بيولوجي يُعزز الهيمنة، لكنه فرَّ من مخترعيه فأصابهم، سواء عن غير قصد، أو مع سبق الإصرار والترصد؛ وبعضهم يعتقد أنه مجرد أداة تحصنت بها الطبيعة ضد عبث الإنسان وإفساده اللامنقطع في البر والبحر ... لكن الفيروس في كل الأحوال يتحدانا بقوة، ويكشف لنا بوحشية عن مدى هشاشتنا، سواء كنا أفرادًا أو جماعات، ويدفعنا إلى إعادة تقييم لحظتنا الوجودية: مَن نحن؟ وما مكاننا في الكون؟ وهل ثمة ما يمكن أن يُهدد بقاءنا كنوعٍ في أي وقت؟! لقد أظهر لنا الفيروس مدى أهمية الحياة، ومدى غباء انخراطنا الدائم في الصراع بدلاً من البحث عن سُبلٍ للتفاهم والتعاون! وعندما ينسحب الجميع في معازلهم، سواء أكانت مختبرات ومشافي تموج بأشرس معارك العلم ضد الفيروس، أو منازل تتضخم فيها مخاوف القدرة على اجتياز الجائحة، تتحول معازل الفلاسفة إلى خلايا فكرية تبسط أشرعة المعنى والمغزى والهدف على الجميع. هذا ما نحاول تبيانه في هذا المقال؛ من عزاء الفلسفة للحيارى والقانطين والموجوعين؛ إلى حالة الطبيعة الهوبزية البادية في الأفق وشروط تجاوزها؛ إلى المعضلات الأخلاقية المنبثقة في غيابات التيه الفيروسية الجديدة؛ إلى معنى الوجود والبقاء والهوية؛ إلى العدو المُكتشف والمُنتظَر في عالم كورونا وما بعده: اللامساواة، والعبث بالاستقرار المُناخي! (shrink)

Clinical researchers should help respect the autonomy and promote the well-being of prospective study participants by helping them make voluntary, informed decisions about enrollment. However, participants often exhibit poor understanding of important information about clinical research. Bioethicists have given special attention to “misconceptions” about clinical research that can compromise participants’ decision-making, most notably the “therapeutic misconception.” These misconceptions typically involve false beliefs about a study’s purpose, or risks or potential benefits for participants. In this article, we describe a misconception involving (...) false beliefs about a study’s potential benefits for non-participants, or its expected social value. This social value misconception can compromise altruistically motivated participants’ decision-making, potentially threatening their autonomy and well-being. We show how the social value misconception raises ethical concerns for inherently low-value research, hyped research, and even ordinary research, and advocate for empirical and normative work to help understand and counteract this misconception’s potential negative impacts on participants. (shrink)

En este trabajo se comparan dos representaciones en competencia sobre el origen de la bioética para llamar la atención sobre un posible cambio de marco teórico dentro de la disciplina. Por un lado, una representación parroquiana del origen de la bioética, centrada en problemas tecnológicos locales, y fundamentada en tradiciones culturales particulares. Por otro lado, una representación universal y pluralista, que enfrenta problemas de justicia y salud globales y que intenta buscar el fundamento normativo del discurso de la bioética en (...) los derechos humanos. Luego de compararlas, desarrollo algunas razones para mostrar por qué las relaciones entre bioética y derechos humanos están sólidamente justificadas. Por último, planteo dos observaciones críticas que deberían tenerse en cuenta al pensar la relación entre bioética y derechos humanos. (shrink)

Assumptions about obesity—e.g., its connection to ill health, its causes, etc.—are still prevalent today, and they make up what I call the medical model of fatness. In this paper, I argue that the medical model was established on the basis of insufficient evidence and has nevertheless continued to be relied upon to justify methodological choices that further entrench the assumptions of the medical model. These choices are illegitimate in so far as they conflict with both the epistemic and social aims (...) of obesity research. I conclude the paper with a partial solution to these epistemic and social shortcomings. (shrink)

Unlike with randomized controlled trials (RCTs) in clinical research, little has been said about the ethical principles that should regulate the use of RCTs in experimental development economics. One well-known principle in clinical research ethics is the principle of clinical equipoise. Some recent commentators suggest that an analogue of clinical equipoise should play a role in experimental development economics. In this article, I first highlight some difficulties with importing the concept to experimental development economics. I then argue that MacKay’s (2018, (...) 2020) notion of policy equipoise avoids these difficulties and has a role to play in experimental development economics. (shrink)

Mainstream views of medical research tell us it should be a fact-based, value-free endeavor: what a scientist (or her funding source) wants or cares about should not influence her findings. At the same time, we also sometimes criticize medical research for failing to embody certain values, e.g. when we criticize pharmaceutical companies for largely ignoring the diseases that affect the global poor. This chapter seeks to reconcile these perspectives by distinguishing appropriate from inappropriate influences of values on medical research. It (...) divides this broad question into two narrower ones, the Role Question (at what points in the research process is value influence potentially acceptable?) and the Content Question (when value influence is potentially acceptable, what specific values should researchers use?), and then draws on the philosophical literature on values in science to explore answers to each of them. (shrink)

This article presents a quantitative way of modeling the interim decisions of clinical trials. While statistical approaches tend to focus on the epistemic aspects of statistical monitoring rules, often overlooking ethical considerations, ethical approaches tend to neglect key epistemic dimension. The proposal is a second-order decision theoretic framework. The framework provides means for retrospective assessment of interim decisions based on a clear and consistent set of criteria that combines both ethical and epistemic considerations. The framework is broadly Bayesian and addresses (...) a fundamental question behind many concerns about clinical trials: What does it take for an interim decision (e.g., whether to stop the trial, or continue) to be a good decision? I provide simulation illustrating the modeling of interim decisions counterfactually using the framework. (shrink)

Context Opioid treatment agreements (OTAs) are documents that clinicians present to patients when prescribing opioids that describe the risks of opioids and specify requirements that patients must meet to receive their medication. Notwithstanding a lack of evidence that OTAs effectively mitigate opioids’ risks, professional organizations recommend that they be implemented, and jurisdictions increasingly require them. We sought to identify the jurisdictions that require OTAs, how OTAs might affect the outcomes of lawsuits that arise when things go wrong, and instances in (...) which the law permits flexibility for clinicians and health care institutions to adopt best practices. -/- Methods We surveyed the laws and regulations of all 50 states and the District of Columbia to identify which jurisdictions require the use of OTAs, the circumstances in which OTA use is mandatory, and the terms OTAs must include (if any). We also surveyed criminal and civil judicial decisions in which OTAs were discussed as evidence on which a court relied to make its decision to determine how OTA use influences litigation outcomes. -/- Findings Results show that a slight majority (27) of jurisdictions now require OTAs. With one exception, the jurisdictions’ requirements for OTA use are triggered at least in part by long-term prescribing. There is otherwise substantial variation and flexibility within OTA requirements. Results also show that even in jurisdictions where OTA use is not required by statute or regulation, OTA use can inform courts’ reasoning in lawsuits involving patients or clinicians. Sometimes, but not always, OTA use legally protects clinicians from liability. -/- Conclusions -/- Our results show that OTA use is entwined with legal obligations in various ways. Clinicians and health care institutions should identify ways for OTAs to enhance clinician–patient relationships and patient care within the bounds of relevant legal requirements and risks. (shrink)

Data Safety Monitoring Boards explores ethical issues confronted by data safety monitoring boards, or DSMBs, overseeing large randomized clinical trials. DSMBs meet on a regular basis to ensure that the expected benefits of a study continue to outweigh its risks and that side effects are monitored. They are empowered to recommend to study sponsors that studies be halted if ethical protections fail. -- from Publisher's Website -/- .

Volume 25, Issue 5, May 2025, Page 101-103.

This case study on the use of robotic and AI systems in care work contexts presents scenarios of the partial transfer of responsibility from (mostly non-professional) careworkers to machine entities. On the basis of a qualitative analysis of a non-representative sample of eight in-depth interviews with people nursing relatives at their homes, five scenarios are introduced that address different degrees of technologization in care ranging from purely human/manual care work to the integrated use of humanoid robots with AI support. The (...) interviewees provide complex answers that outline varying concepts of everyday ethics pertaining to the use of digital and robotic systems in curative and nursing contexts. The results point at ethical challenges for people providing care work and deepen debates on gradual diffusions of responsibility. (shrink)

The advancement of and prospects for stem cell research raise a number of specific ethical issues. While navigating the ethical landscape of stem cell research is often challenging for biology researchers and biotechnology innovators, it is also difficult for the public and other persons of concern (from ethicists to policy-makers) to grasp the technicalities of a burgeoning field that develops in many directions. Organoids are one of these new biotechnological constructs that are currently eliciting a rich debate in bioethics. In (...) this guide, we argue that different types of organoids have different emerging properties with different ethical implications. Going from general properties to particular ones, we propose a typology of organoid technology and other associated biotechnology from a philosophical and ethical perspective. We point to relevant ethical issues and try to convey the sense of uncertainty peculiar to ongoing research and emerging technological objects. (shrink)

Today scientists are expected to be more accountable and transparent than at any time in history. Globally the pursuit of knowledge creation enjoys a place of distinction, and the public expects to reap considerable benefit from the innovative contributions made by researchers. It is therefore more important than ever that ethics, transparency and professionalism explicitly guide research integrity. Despite the clear importance of acquiring a fundamental understanding of clinical trials in the context of health research and innovation, medical training generally (...) fails to cover clinical trial integrity in its curriculum, including it neither at undergraduate nor at postgraduate levels. This new book provides a curriculum to address this gap, offering best practice guidelines to improve the quality, openness and trustworthiness of clinical trials and filling a current void in the market. Key Features: The first book on clinical trial integrity. Provides clear guidance on how to ensure probity in peer review, appraisal of trials and investigation of complaints concerning misconduct in clinical trials. Trains and supports researchers globally in how to undertake trials with integrity. Ensures the increasing demand for public documentation of all aspects throughout the lifecycle of a clinical trial can be met. The book is essential reading for master and doctoral students undertaking courses in clinical trials, epidemiology and medical statistics and an invaluable reference for medical journal editors and peer reviewers, clinicians who recruit patients into trials, pharmaceutical industry professionals, patient and public representatives who engage in clinical trials, systematic reviewers, guideline writers, funders and regulators of clinical trials. (shrink)

In the Name of Progress: The Dark Side of Medical Research is a comprehensive exploration of the dark side of medical progress, examining a series of unethical medical experiments conducted over the past century. This book delves into notorious cases like the Tuskegee Syphilis Study, the Guatemala Syphilis Experiment, and the Holmesburg Prison experiments, among others, to shed light on the ethical violations and exploitation that occurred under the guise of scientific advancement. Each chapter methodically uncovers the disturbing details of (...) these studies, analyzing the impact on the victims and the long-term effects on public trust and medical ethics. By providing a critical examination of the ethical breaches in historical medical research, this book emphasizes the importance of informed consent, the protection of vulnerable populations, and the need for stringent ethical standards in medical studies. It aims to educate and provoke thoughtful discussion on the balance between scientific discovery and ethical conduct, highlighting the necessity of safeguarding human rights in medical research and the importance of maintaining ethical integrity in the pursuit of scientific knowledge. (shrink)

This book offers guidance and the current scholarship surrounding institutional review boards policies and procedures, human research protections for researchers and principal investigators, data privacy, data ethics, and other areas of interest related to human subjects research.

Bioethics: 50 Puzzles, Problems, and Thought Experiments collects 50 cases—both real and imaginary—that have been, or should be, of special interest and importance to philosophical bioethics. Cases are collected together under topical headings in a natural order for an introductory course in bioethics. Each case is described in a few pages, which includes bioethical context, a concise narrative of the case itself, and a discussion of its importance, both for broader philosophical issues and for practical problems in clinical ethics and (...) health policy. Each entry also contains a brief, annotated, list of suggested readings. In addition to the classic cases in bioethics, the book contains discussion of cases that involve several emerging bioethical issues: especially, issues around disability, social justice, and the practice of medicine in a diverse and globalized world. (shrink)

Laspro et al. (2024) present an insightful survey of ethical issues emerging in first-in-human whole eye transplants (WET). Their discussion is applicable to a broad range of first-in-human surgica...

At the height of the Covid pandemic, there was much discussion in the literature about using human challenge trials (HCTs) to expedite the development of effective Covid-19 vaccines. Historically, reluctance to fully accept HCTs has largely been due to potential conflicts with the principle of nonmaleficence in bioethics. Only a few commentators have explored this topic in depth. In this paper, we claim that to address ethical concerns regarding HCTs, two types of ethical reasons should be identified and investigated: first-order (...) reasons that can be given to claim that a practice in itself is in direct conflict with the principles of bioethics; and second-order reasons that take into consideration how a practice is carried out and its consequences. We argue that understanding these ethical reasons is crucial for guiding the implementation of HCTs. We investigate a first-order reason against HCTs when the practice is in conflict with the principle of nonmaleficence, and when it is not. Following this argument and assuming there is no first-order reason based on nonmaleficence that hinders using HCTs, we argue there may be second-order reasons to guide implementation of this practice, such as difficulty in obtaining informed consent; protection of the weaker party; and trust in the scientific enterprise. (shrink)

This article presents a framework of ethical analysis for anticipatory evaluation of advanced biopreservation technologies and employs the framework illustratively in three domains. The framework features four clusters of general ethical considerations: (1) Producing Benefits, Minimizing Harms, Balancing Benefits, Risk, and Costs; (2) Justice, Fairness, Equity; (3) Respect for Autonomy; and (4) Transparency, Trustworthiness, and Public Trust.

The case (Dawson et al. 2024) describes an Institutional Review Board (IRB) chair who seeks consultation about waiving the requirement that investigators obtain prospective, informed consent for collection of microbiome samples by swabbing the perianal region of severely burned patients shortly after their admission to an intensive care unit (ICU). We argue that it is ethically permissible to waive informed consent requirements for the perianal swab and that the IRB should approve a waiver as permitted by regulations.

Afro-cultural research ethics is in a nascent phase within the field of research ethics as a whole and requires more attention and in-depth articulation. With specific case studies, this vital volume provides unique perspectives on topics such as social autonomy vis-a-vis interests of individuals.

Reprint of an article that first appeared in Theoretical Medicine and Bioethics (2017).

A central feature of experimental development economics is the use of randomized controlled trials (RCTs) to evaluate the effectiveness of prospective socioeconomic interventions. The use of RCTs in development economics raises a host of ethical issues which are just beginning to be explored. In this article, I address one ethical issue in particular: the routine use of the status quo as a control when designing and conducting a development RCT. Drawing on the literature on the principle of standard care in (...) medical research ethics, as well as considerations of distributive justice in non-ideal circumstances, I argue that the practice of using the status quo as a control is ethically justifiable. However, I add an important qualification based on the natural duty of rescue to address the concern that my account is overly permissive. (shrink)

Primarily, this article emphasises that while conducting research, especially one involving human subjects, researchers are expected to comply with applicable global and national ethical standards. Should a researcher fail to do so, he/she stands the risk of breaching research ethics, and this is capable of rendering his/her research unacceptable. Accordingly, this article, making reference to relevant ethical theories, critically examines and analyses the actions of a researcher who set out to investigate treatment recommendations for diarrhoea. Ultimately, a number of ethical (...) pitfalls in the stated research are x-rayed and some recommendations for subsequent studies are provided in this paper. (shrink)

This study explores how qualitative health researchers navigate the demands of medical research ethics committees in Germany where qualitative research is subject to approval only when it is conducted in medical contexts. We present the results of a grounded theory study to investigate qualitative health researchers’ experiences with procedural ethics and the strategies they adopt to navigate its demands. Our analysis revealed six dimensions of experience and three strategies adopted by researchers to navigate the demands of medical research ethics committees. (...) All participants agreed that research ethics is of high importance in qualitative health research, but strategies to navigate the demands of medical research ethics committees ranged from avoiding, and adapting, to transforming the procedures of ethics review. Based on our findings, we provide recommendations for improving the ethics review of qualitative health research. (shrink)

In a challenge trial, research subjects are purposefully exposed to some pathogen in a controlled setting, in order to test the efficacy of a vaccine or other experimental treatment. This is an example of medical effective altruism (MEA), where individuals volunteer to risk harms for the public good. Many bioethicists rejected challenge trials in the context of Covid‐19 vaccine research on ethical grounds. After considering various grounds of this objection, I conclude that the crucial question is how much harm research (...) subjects can permissibly risk. But we lack a satisfying way of making this judgment that does not appeal simply to the intuitions of doctors or bioethicists. I consider one recent and structurally plausible approach to critically evaluating the harm question. Alex London defends a social consistency test for research risks: we should compare the risks undertaken by research subjects to relevantly similar risks which are accepted in other spheres of society. I argue there is no good reason not to consider volunteer military service as a relevant social comparison. This implies there is essentially no cap on acceptable risks on the social consistency rationale. In short, if soldiers can be heroes, why can't research volunteers? (shrink)

Research regulations around the world do not impose any limits on the risks to which consenting adults may be exposed. Nonetheless, most review committees regard some risks as too high, even for consenting adults. To justify this practice, commentators have appealed to a range of considerations which are external to informed consent and the risks themselves. Most prominently, some argue that exposing consenting adults to very high risks has the potential to undermine public trust in research. This justification assumes that (...) it is not the magnitude of the risks themselves which raises concern, but the way in which the public might respond to them. This justification thus depends on the possibility that the public will find out about the risks and respond to them in the specified way. Like the other proposed external justifications, it thereby fails to offer a reason to think that exposing consenting adults to very high risks is problematic in itself. In the present paper, we describe and endorse a different justification. Rather than appealing to external factors, we argue that limits on risks for consenting adults trace to internal limits on informed consent, to limits on the things consent can and cannot make ethically permissible. In doing so, we aim to provide a firmer conceptual basis for the view that some research risks are unacceptably high, no matter how the research is conducted. (shrink)

A novel advantage of the use of machine learning (ML) systems in medicine is their potential to continue learning from new data after implementation in clinical practice. To date, considerations of the ethical questions raised by the design and use of adaptive machine learning systems in medicine have, for the most part, been confined to discussion of the so-called “update problem,” which concerns how regulators should approach systems whose performance and parameters continue to change even after they have received regulatory (...) approval. In this paper, we draw attention to a prior ethical question: whether the continuous learning that will occur in such systems after their initial deployment should be classified, and regulated, as medical research? We argue that there is a strong prima facie case that the use of continuous learning in medical ML systems should be categorized, and regulated, as research and that individuals whose treatment involves such systems should be treated as research subjects. (shrink)

Can we permissibly accelerate vaccine testing even if this increases risk to study participants? During the COVID-19 pandemic, researchers, policymakers, and bioethicists debated ways in which vaccine development could be expedited. One suggestion were human challenge trials which only started after safe and efficacious vaccine had already been developed. Was this hesitation justified? Can challenge trials play a role in future pandemics? I defend both a version of challenge trials – a low-dosage challenge trial – and a faster option for (...) post-challenge trial safety testing. My argument draws on a new framework for risks in biomedical research. The new framework, embedded in a broader approach to the ethics of risk, can justify seemingly risky research while remaining strongly protective of the rights and interests of research participants. My argument furthermore draws on considerations about the connection between the risks to study participants, the benefits to nonparticipants, and the number of participants involved. (shrink)

We argue that there are neither scientific nor social reasons to require gathering ethno-racial data, as defined in the US legal regulations if researchers have no prior hypotheses as to how to connect this type of categorisation of human participants of clinical trials with any mechanisms that could explain alleged interracial health differences and guide treatment choice. Although we agree with the normative perspective embedded in the calls for the fair selection of participants for biomedical research, we demonstrate that current (...) attempts to provide and elucidate the criteria for the fair selection of participants, in particular, taking into account ethno-racial categories, overlook important epistemic and normative challenges to implement the results of such race-sorting requirements. We discuss existing arguments for and against gathering ethno-racial statistics for biomedical research and present a new one that refers to the assumption that prediction is epistemically superior to accommodation. We also underline the importance of closer interaction between research ethics and the methodology of biomedicine in the case of population stratifications for medical research, which requires weighing non-epistemic values with methodological constraints. (shrink)

Targeted modifications of the human epigenome, epigenome editing (EE), are around the corner. For EE, techniques similar to genome editing (GE) techniques are used. While in GE the genetic information is changed by directly modifying DNA, intervening in the epigenome requires modifying the configuration of DNA, for example, how it is folded. This does not come with alterations in the base sequence (‘genetic code’). To date, there is almost no ethical debate about EE, whereas the discussions about GE are voluminous. (...) Our article introduces EE into bioethics by translating knowledge from science to ethics and by comparing the risks of EE with those of GE. We, first (I), make the case that a broader ethical debate on EE is due, provide scientific background on EE, compile potential use-cases and recap previous debates. We then (II) compare EE and GE and suggest that the severity of risks of novel gene technologies depends on three factors: (i) the choice of an ex vivo versus an in vivo editing approach, (ii) the time of intervention and intervention windows and (iii) the targeted diseases. Moreover, we show why germline EE is not effective and reject the position of strong epigenetic determinism. We conclude that EE is not always ethically preferable to GE in terms of risks, and end with suggestions for next steps in the current ethical debate on EE by briefly introducing ethical challenges of new areas of preventive applications of EE (III). (shrink)

The case describes researchers who are seeking ethics guidance on communicating with participants in a phase-1 COVD-19 vaccine trial about FDA-authorized COVID-19 vaccines (Wilfond, Duenas, and Johnson 2023). The researchers want help choosing among three options they have identified for encouraging participants to obtain one of the authorized vaccines. We argue that research ethics consultants should consider going beyond this question to address another ethics concern the researchers might have overlooked.

Smajdor argues that “recognition” is the solution to the “reifying attitude” that results from “the urge to protect ‘vulnerable’ people through exclusion from research”. Drawing on theories of reification, we argue that it is the concepts of autonomy and vulnerability themselves that have been reified, resulting in the impoverishment of approaches to autonomy at law and in research ethics. Overcoming such reification demands a deeper consideration of the grounds on which vulnerable individuals are owed recognition and thereby the forms such (...) recognition should take. Smajdor argues for a recognition that appeals to autonomy and that manifests in providing vulnerable individuals with the opportunity to assent. The problem is that this kind of recognition is dependent on a more fundamental kind. It is this second form of recognition that would need to do the heavy lifting for assent-based frameworks to avoid the same problems we find with consent. (shrink)

Translation failure occurs when a treatment shown to be safe and effective in one type of population does not produce the same result in another. We are currently in a crisis involving the translatability of preclinical studies to human populations. Animal trials are no better than a coin toss at predicting the safety and efficacy of drugs in human trials, and the high failure rate of drugs entering human trials suggests that most of the suffering of laboratory animals is futile, (...) creating no commensurate benefit for human patients. Here, I argue that animal ethics committees have a role to play in getting us out of this crisis. Inadequate representation is a known contributor to translation failures and is a matter of both scientific and ethical concern. Ethical review committees have the authority to address it by reprioritising the values already enshrined in their guiding principles. (shrink)

In this issue, Morain and Largent (2023) raise a pressing issue arising in the context of embedded research—the nature and extent of investigator duties to patient-participants when the line betwee...