This book examines the ethical issues in pediatric medical research. It argues that policies and practices on the participation of children must focus primarily on minimizing risks. It offers specific recommendations to revise Subpart D of the federal regulations to provide greater protection where necessary and remove obstacles that do not provide additional protection but interfere with access. The book is divided into four sections. Section 1 focuses on the issue of access versus protection in pediatric research. (...) Section 2 deals with challenges to regulations. Section 3 discusses the strengths and limits of current regulations, while different case studies are examined in Section 4. (shrink)

A review of fraud in medical research in Britain, Europe, the USA and Australia. It includes a history of known cases of fraud since 1974 and discusses ways for detecting and dealing with fraud that have been devised by government agencies, pharmaceutical companies, academic institutions and scientific publications (especially medical journals).

Biomedical research, especially pharmaceutical research, has been criticised for engaging in practices that lead to over-estimations of the effectiveness of medical treatments. A central issue concerns the reporting of absolute and relative measures of medical effectiveness. In this paper we critically examine proposals made by Jacob Stegenga to (a) give priority to the reporting of absolute measures over relative measures, and (b) downgrade the measures of effectiveness (effect sizes) of the treatments tested in clinical trials (Stegenga, (...) 2015a). After exposing significant flaws in a central case study used by Stegenga to bolster his first proposal (a), we go on to argue that neither of these proposals is defensible (a or b). We defend the practice, in line with the New England Journal of Medicine, of reporting both absolute and relative measures whenever feasible. (shrink)

The Experiment Must Continue is a beautifully articulated ethnographic history of medical experimentation in East Africa from 1940 through 2014. In it, Melissa Graboyes combines her training in public health and in history to treat her subject with the dual sensitivities of a medical ethicist and a fine historian. She breathes life into the fascinating histories of research on human subjects, elucidating the hopes of the interventionists and the experiences of the putative beneficiaries. Historical case studies highlight (...) failed attempts to eliminate tropical diseases, while modern examples delve into ongoing malaria and HIV/AIDS research. Collectively, these show how East Africans have perceived research differently than researchers do and that the active participation of subjects led to the creation of a hybrid ethical form. By writing an ethnography of the past and a history of the present, Graboyes casts medical experimentation in a new light, and makes the resounding case that we must readjust our dominant ideas of consent, participation, and exploitation. With global implications, this lively book is as relevant for scholars as it is for anyone invested in the place of medicine in society. (shrink)

Medical research data is sensitive personal data that needs to be protected from unauthorized access and unintentional disclosure. In a research setting, sharing of data within the scientific community is necessary in order to make progress and maximize scientific benefits derived from valuable and costly data. At the same time, convincingly protecting the privacy of people participating in medical research is a prerequisite for maintaining trust and willingness to share. In this commentary, we will address (...) this issue and the pitfalls involved in the context of the PEP project1 that provides the infrastructure for the Personalized Parkinson’s Project,2 a large cohort study on Parkinson’s disease from Radboud University Medical Center, in cooperation with Verily life Sciences, an Alphabet subsidiary. (shrink)

We consider a particular attempt to justify medical research and the practice of medicine as moral imperatives; in doing this we are led into a comparison of consequential and deontological justifications of intention and action. We conclude that the justification of research and medicine is consequential.

In this article, I provide a new account of the basis of medical researchers' ancillary care obligations. Ancillary care in medical research, or medical care that research participants need but that is not required for the validity or safety of a study or to redress research injuries, is a topic that has drawn increasing attention in research ethics over the last ten years. My view, the relationship‐based approach, improves on the main existing theory, (...) Richardson and Belsky's ‘partial‐entrustment model’, by avoiding its problematic restriction on the scope of health needs for which researchers could be obligated to provide ancillary care. Instead, it grounds ancillary care obligations in a wide range of morally relevant features of the researcher‐participant relationship, including the level of engagement between researchers and participants, and weighs these factors against each other. I argue that the level of engagement, that is, the duration and intensity of interactions, between researchers and participants matters for ancillary care because of its connection to the meaningfulness of a relationship, and I suggest that other morally relevant features can be grounded in researchers' role obligations. (shrink)

Most people know precious little about the risks and benefits of participating in a clinical trial--a medical research study involving some innovative treatment for a medical problem. Yet millions of people each year participate anyway. Patients at Risk explains the reality: that our current system intentionally hides much of the information people need to make the right choice about whether to participate. Witness the following scenarios: -Hundreds of patients with colon cancer undergo a new form of keyhole (...) surgery at leading cancer centersnever -Tens of thousands of women at high risk of developing breast cancer are asked to participate in a major research study. They are told about the option of having both breasts surgically removed but not told about the option of taking a standard osteoporosis pill that might cut the risk of getting breast cancer by one-half or more. Patients at Risk written by two nationally prominent experts, is the first book to reveal the secrets that many in the research establishment have fought long and hard to keep from patients. It shows why options not commonly knownincluding getting a new treatment outside of a research studycan often be the best choice. It explains how patients can make good decisions even if there is only limited information about a treatments effect. And it does this through the eye-opening stories of what is happening daily to thousands of people. Day after day, we are learning how little we know about what really works. Headlines regularly announce that a previously unquestioned treatmenthormone replacement therapy, drugs such as Vioxx or Celebrexmay now be much riskier than we thought. The latest book in a surge of recent books criticizing the medical establishment (but the first to look at clinical trials specifically), Patients at Risk helps to empower patients to survive in a world of medical uncertainty, and makes positive recommendations for systemic reform. (shrink)

Medical research aims to achieve a better scientific understanding of health and disease. It is firstly undertaken for the improvement of medical care in general, not excluding a potential direct benefit for participants undergoing such research. There is a traditional conflict between the fundamental rights and the dignity of those participating individuals and the interests of science, researchers and even the society. The Convention of Human Rights and Biomedicine of the Council of Europe is a new (...) legally binding instrument for the solution of these conflicts. (shrink)

The UK’s Medical Research Council (MRC) introduced a specific policy and procedure for inquiring into allegations of scientific misconduct in December 1997; previously cases had been considered under normal disciplinary procedures. The policy formally covers staff employed in MRC units, but those in receipt of MRC grants in universities and elsewhere are expected to operate under similar policies. The MRC’s approach is stepwise: preliminary action; assessment to establish prima facie evidence of misconduct; formal investigation; sanctions; and appeal. Strict (...) time limits apply at all stages. The procedure will be evaluated after two years. The indications so far are that the procedure is robust, and its clarity and transparency have been an asset to all parties. The MRC is also convinced that it is equally important to achieve a working culture that fosters integrity. Thus education and training in good research practices are fundamental to the prevention of research misconduct. (shrink)

Introduction TEMPE (Teaching Ethics: Material for Practitioner Education) is a two-year research project (2000-2002) funded by the European Commission ...

This book provides a current review of Medical Research Ethics on a global basis. The book contains chapters that are historically and philosophically reflective and aimed to promote a discussion about controversial and foundational aspects in the field. An elaborate group of chapters concentrates on key areas of medical research where there are core ethical issues that arise both in theory and practice: genetics, neuroscience, surgery, palliative care, diagnostics, risk and prediction, security, pandemic threats, finances, technology, (...) and public policy.This book is suitable for use from the most basic introductory courses to the highest levels of expertise in multidisciplinary contexts. The insights and research by this group of top scholars in the field of bioethics is an indispensable read for medical students in bioethics seminars and courses as well as for philosophy of bioethics classes in departments of philosophy, nursing faculties, law schools where bioethics is linked to medical law, experts in comparative law and public health, international human rights, and is equally useful for policy planning in pharmaceutical companies. (shrink)

The use of genome-wide association studies in medical research and the increased ability to share data give a new twist to some of the perennial ethical issues associated with genomic research. GWAS create particular challenges because they produce fine, detailed, genotype information at high resolution, and the results of more focused studies can potentially be used to determine genetic variation for a wide range of conditions and traits. The information from a GWA scan is derived from DNA (...) that is a powerful personal identifier, and can provide information not just on the individual, but also on the individual's relatives, related groups, and populations. Furthermore, it creates large amounts of individual-specific digital information that is easy to share across international borders. This paper provides an overview of some of the key ethical issues around GWAS: consent, feedback of results, privacy, and the governance of research. Many of the questions that lie ahead of us in terms of the next generation sequencing methods will have been foreshadowed by GWAS and the debates around ethical and policy issues that these have created. (shrink)

ABSTRACT This paper reports on a multidisciplinary meeting held to discuss ethical issues in medical research in the developing world. Many studies, including clinical trials, are conducted in developing countries with a high burden of disease. Conditions under which this research is conducted vary because of differences in culture, public health, political, legal and social contexts specific to these countries. Research practices, including standards of care for participants, may vary as a result. It is therefore not (...) surprising that ethical issues emerge. This meeting sought to identify and discuss these issues from the perspectives of the many actors in such research, including community representatives, with a view to finding ethical and pragmatic solutions to these issues. Dialogue between these actors was also promoted, with a view to identifying the need to develop such dialogue in future. Drawing from the experiences of the speakers, the colloquium attempted to outline some answers to several key questions characterising the field today. Experiences related to epidemiologic research, vaccine trials, drug trials, diagnostic tests and to some fundamental ethical issues in health research. Speakers were from different countries, disciplines and professions. The meeting provided a forum for consultation and debate between different ethics actors. Both encouraging findings and challenges emerged. (shrink)

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard (...) view of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

This is a comprehensive and practical guide to the ethical issues raised by different kinds of medical research, and is the first such book to be written with the needs of the researcher in mind. Clearly structured and written in a plain and accessible style, the book covers every significant ethical issue likely to be faced by researchers and research ethics committees. The author outlines and clarifies official guidelines, gives practical advice on how to adhere to these, (...) and suggests procedures in areas where official recommendations are vague or absent. This invaluable handbook will help researchers identify and address the ethical issues at an early stage in the design of their studies, to avoid unnecessary delay and to safeguard the wellbeing of patients and healthy volunteers. It will also be extremely useful to members of research ethics committees. (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)

Regulation and governance of medical research is frequently criticised by researchers. In this paper, we draw on Everett Hughes’ concepts of professional licence and professional mandate, and on contemporary sociological theory on risk regulation, to explain the emergence of research governance and the kinds of criticism it receives. We offer explanations for researcher criticism of the rules and practices of research governance, suggesting that these are perceived as interference in their mandate. We argue that, in spite (...) of their complaints, researchers benefit from the institutions of governance and regulation, in particular by the ways in which regulation secures the social licence for research. While it is difficult to answer questions such as: “Is medical research over-regulated?” and “Does the regulation of medical research successfully protect patients or promote ethical conduct?”, a close analysis of the social functions of research governance and its relationship to risk, trust, and confidence permits us to pose these questions in a more illuminating way. (shrink)

Objective Analyze racial differences in comfort with medical research using an alternative to the traditional approach that treats white people as a raceless norm.Methods Quantitative analysis of survey responses (n = 1,570) from Black and white residents of the US to identify relationships between perceptions of research as a right or a risk, and comfort participating in medical research.Results A lower proportion of white respondents reported that medical experimentation occurred without patient consent (p < (...) 0.001) and a higher proportion of white respondents reported that it should be their right to participate in medical research (p = 0.02). Belief in one’s right to participate was significantly predictive of comfort (b = 0.37, p < 0.001). Belief in experimentation without consent was significantly predictive of comfort for white respondents but not for Black respondents in multivariable analysis.Conclusions A rights-based orientation and less concern about the risks of medical research among white respondents demonstrate comparative advantage. Efforts to diversify medical research may perpetuate structural racism if they do not (1) critically engage with whiteness and its role in comfort with participation, and (2) identify and respond specifically to the needs of Black patients. (shrink)

There is sufficient evidence that intellectual property rights are corrupting medical research. One could respond to this from a moral or from an epistemic point of view. I take the latter route. Often in the sciences factual discoveries lead to new methodological norms. Medical research is an example. Surprisingly, the methodological change required will involve political change. Instead of new regulations aimed at controlling the problem, the outright socialization of research seems called for, for the (...) sake of better science. I appeal to an analogy between socialized medicine and socialized research. †To contact the author, please write to: Department of Philosophy, University of Toronto, Toronto, Ontario M5R 2M8, Canada; e‐mail: [email protected]. (shrink)

BackgroundIt has been argued that ethics review committees—e.g., Research Ethics Committees, Institutional Review Boards, etc.— have weaknesses in reviewing big data and artificial intelligence research. For instance, they may, due to the novelty of the area, lack the relevant expertise for judging collective risks and benefits of such research, or they may exempt it from review in instances involving de-identified data.Main bodyFocusing on the example of medical research databases we highlight here ethical issues around de-identified (...) data sharing which motivate the need for review where oversight by ethics committees is weak. Though some argue for ethics committee reform to overcome these weaknesses, it is unclear whether or when that will happen. Hence, we argue that ethical review can be done by data access committees, since they have de facto purview of big data and artificial intelligence projects, relevant technical expertise and governance knowledge, and already take on some functions of ethical review. That said, like ethics committees, they may have functional weaknesses in their review capabilities. To strengthen that function, data access committees must think clearly about the kinds of ethical expertise, both professional and lay, that they draw upon to support their work.ConclusionData access committees can undertake ethical review of medical research databases provided they enhance that review function through professional and lay ethical expertise. (shrink)

Amending and Defending Critical Contextual Empiricism: Lessons from Medical Research In Science as Social Knowledge (1990) and The Fate of Knowledge (2002), Helen Longino develops a social epistemological theory known as Critical Contextual Empiricism (CCE). While Longino’s work has been generally well-received, there have been a number of criticisms of CCE raised in the philosophical literature in recent years. In this paper I outline the key elements of Longino’s theory and propose several modifications to the four norms offered (...) by the account. The revisions I propose are shaped by a number of developments in the medical context in recent years. The modified norms, which determined whether a particular community produces objective knowledge, are thus: 1. Avenues for Criticism – there must be recognized avenues for criticism, and these avenues must be publicly accessible and require transparent disclosure of all relevant information (including competing interests) from those who present their ideas. It must also be a community requirement that all members present their ideas for critical scrutiny if they wish them to be recognized as knowledge. 2. Responsiveness to Criticism – the community must be responsive to criticism. 3. Shared Public Standards – there must be some shared standards that determine community membership. Outsiders to a particular community are welcome to engage in critical debates as long as they share at least one of the community standards with the target community. 4. Cultivation of Diverse Perspectives – communities must cultivate diverse perspectives, that is, the perspectives of those who express strong dissent. The version of CCE I defend gives the principle of diversity a more central role than the original and provides greater specification of two of the other norms in light of challenges faced by medical researchers in recent years. The medical context provides us with a number of cautionary tales in which knowledge production that appears to meet the original four norms has been seriously compromised by particular social interests. The proposed modifications attempt to address these ‘loopholes’ in a way that is not ad hoc. I argue that the modifications I suggest are in line with the underlying assumptions and goals of CCE. The modified version of CCE also offers resources for defending CCE against the criticisms leveled against it by Miriam Solomon & Alan Richardson, Alvin Goldman and Philip Kitcher as well as one general concern arising out of a recent work by David Michaels. I provide responses to these criticisms in the final section of the paper. Throughout the paper I connect the theoretical work done in social epistemology to the real practice of knowledge-production as is occurs in the medical context. In light of the variety of social pressures influencing contemporary scientific research, and the role of science in shaping public policy, I argue that a rigorous social epistemology such as CCE is indispensable for understanding and assessing contemporary scientific practice. (shrink)

BackgroundIn recent years, some researchers have engaged in scientific misconduct such as fabrication, falsification, and plagiarism to achieve higher research performance. Considering their detrimental effects on individuals’ health status (e.g., patients, etc.) and extensive financial costs levied upon healthcare systems, such wrongdoings have even more salience in medical sciences. However, there has been little discussion on the possible influence of medical researchers’ existing creative performance on scientific misconduct, and the moral psychological mechanisms underlying those effects are still (...) poorly understood.MethodsWe build a moderated mediation model to test how medical researchers’ creative performance affects their scientific misconduct and explore the role of moral licensing and moral identity in this process. Based on situational experiments and projection techniques, 287 medical researchers in China participated in a survey.ResultsMedical researchers’ creative performance positively relates to scientific misconduct, and moral licensing plays a mediating role in the relationship between them. In addition, moral identity has a negative moderating effect on the mediating effect of moral licensing on creative performance and scientific misconduct.ConclusionMoral licensing plays a fully mediating role in the relationship between creative performance and scientific misconduct. And moral identity negatively moderates the indirect effect of creative performance on scientific misconduct through moral licensing. The findings provide theoretical and practical implications for the prevention of medical researchers’ scientific misconduct. (shrink)

Bowman-Smart et al. (2023) argue for a framework to examine the ethical issues associated with genetic screening for non-medical traits in the context of noninvasive prenatal testing (NIPT). Such s...

The most basic question any medical researcher should ask oneself is: Why ought I engage in medical research? Like any ethical question, there are valid and invalid answers to it. These answers are the reasons why one should engage in this enterprise. There seem to be three such reasons. (1) Since the subjects of medical research are fellow human beings and it is for their sake medical research is to be conducted, one’s first (...) valid reason for engaging in medical research is that this research is primarily for their good, both individually and collectively. Using human subjects for any purpose other than their good is an immoral practice, hence any reason for it is ethically invalid. (2) Since medical research is science, one’s second valid reason for engaging in medical research is the pursuit of truth. Falsification of data or drawing deceitful conclusions from data is an immoral practice, hence any reason for it is ethically invalid. In order for one’s scientific research to be trusted as true, we have to be convinced that the researchers sharing it with us are truthful. (3) Since medical researchers are members of a scientific community already operating before they entered it, their research is their participation in a public discourse where the questions to which their research is a response have already been raised. As such, medical researchers are responsible for the common good of the scientific community by sharing their research with the community that has enabled researchers to supply answers to common scientific questions through their own research. This is the third valid reason for engaging in medical research. Taking the content of one’s research as one’s private property to be done with however one pleases is an immoral practice, hence any reason for it is ethically invalid. This chapter will explore these three questions more fully and, it is hoped, will supply some ethically convincing arguments for what is outlined above. (shrink)

Despite the prominence of healthcare-relatedconcerns in public debate, the ground remainsinfertile for the idea of conscripting citizensinto medical research. Reluctance to entertainthe thought of a system where nearly everyonecould be selected for service might reflectuncertainty about what the project wouldinvolve. There might also be a fear that themore crucial issue is how to protect researchsubjects within current, voluntary systems. Nodoubt reluctance to explore a system ofuniversal service results from the common hopethat each of us might avoid research (...) in anycapacity besides researcher. A system of fullcivic participation might, however, avoid manyof the usual objections. Ethics regulations,including informed-consent guidelines, couldfor the most part remain in force. Though thesystem would compel people to serve, it couldremain responsive to principles of autonomy andjustice if it centered on broad publiceducation, community representation, and alottery-type selection process. The systemcould draw from the largest possiblecross-section of society, and offer conscriptsthe widest possible range of service. In thisway, a compulsory system might reconcile theexpectations about healthcare with researchneeds. (shrink)

An axiom of medical research ethics is that a protocol is moral only if it has a “favorable risk-benefit ratio”. This axiom is usually interpreted in the following way: a medical research protocol is moral only if it has a positive expected value -- that is, if it is likely to do more good (to both subjects and society) than harm. I argue that, thus interpreted, the axiom has two problems. First, it is unusable, because it (...) requires us to know more about the potential outcomes of research than we ever could. Second, it is false, because it conflicts with the so-called “soft paternalist” principles of liberal democracy. In place of this flawed rule I propose a new way of making risk-benefit assessments, one that does comport with the principles of liberalism. I argue that a protocol is moral only if it would be entered into by competent subjects who are informed about the protocol. The new rule this eschews all pseudo-utilitarian calculation about the protocol’s likely harms and benefits. (shrink)

Over the last few decades, there has been a push towards evidence-based medicine, with the medical fraternity recognising and embracing the improved outcomes brought about by this approach. Central to this is the ability of healthcare professionals across all levels to be able to understand and undertake scientifically sound efforts to gather and learn from this evidence. This can be on a local level, for example departmental audits, or on a national or international level, as is the case with (...) large randomised controlled trials. Unfortunately, although academic medicine topics such as research and teaching are often discussed and taught at medical schools - many of which are at the forefront of international research efforts - medical students and junior doctors rarely get the chance to participate in any real-world studies, or indeed critique any practice changing studies in a meaningful way for themselves. The situation in regard to teaching is similar. Peer to peer teaching opportunities may be limited to self-arranged sessions with little to no guidance or formal training in how to do this key task, which will be crucial for the rest of one's career. This is despite these activities being recognised as essential by undergraduate and post-graduate educators. In fact, they are a key part of selection for postgraduate employment. Candidates that demonstrate awareness of and proficiency with research and other academic activities such as teaching are highly sought after. However, many candidates, particularly those who don't take time out of their undergraduate programmes or pursue a higher degree, tend not to have had the exposure and opportunities to engage with these academic activities as students and junior healthcare professionals. Many will have never undertaken any formal research or teaching during this time. Furthermore, we have found that many students with an interest in medical research don't have the skills and experience required to get started, and may lack mentors and senior colleagues with the time, interest or experience to help them. (shrink)