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)

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)

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)

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)

Different ethical principles conflict in research conducted in emergency research. Clinical care and its development should be based on research. Patients in critical clinical condition are in the greatest need of better medicines. The critical condition of the patient and the absence of a patient representative at the critical time period make it difficult and sometimes impossible to request an informed consent before the beginning of the trial. In an emergency, care decisions must be made in a short period of (...) time, and the more time is wasted, the more the risk of death or severe tissue damage and incapacity increases. Consent requests take time, and so the time period before treatment might put the patient’s life in jeopardy. Not requesting consent before a trial is also contradictory. A person should not be forced to participate in a trial against his or her will. Due to the dark history of medical research previously, international declarations and conventions have set up ethical principles for medical research. They emphasize the autonomy of the research participant—or his or her legal representative—to give a free and informed consent prior to the initiation of research. In the case of a critical emergency, the unconscious state of the patient, the emotional stress of family members or the lack of time to start life-sustaining measures may often restrict the possibilities of communicating with the patient or his/her representative. Therefore, written informed consent is difficult to achieve, and its voluntariness in emergency situations is, at best, open to question. The mortality of patients is high without clinical interventions in emergency research. Random selection of patients is difficult and requires extra work from personnel in the emergency rooms. Recruitment, information and asking for consent may also take time, postpone the initiation of treatment and increase the risk of death and irreversible tissue and organ damage, and therefore be risky for the patient. It is therefore essential that the health care professionals recruiting suitable research participants are well motivated and well trained. Medical research in an emergency setting should always be regarded as an exceptional situation requiring special provisions. Only such research should be done as cannot be done in other conditions. An independent body must approve the research protocol and the ways in which the consent of the participant or proxy are to be sought. In addition, the trial must be expected to result in direct and significant benefit for the research participants. If research without prior consent is not approved, the development of emergency care is threatened. On the other hand, if prior consent is not required, a person could be recruited into a clinical trial against his or her will. Doing good and avoiding harm, and respecting the autonomy of the patient are in conflict in the context of emergency medical research. To develop better medicines for patients experiencing acute medical emergencies, research into such conditions should be allowed. Research participants should have the possibility to participate or refuse to participate in research that may benefit them and other patients. The risk of irreversible damage occurring as the consequence of time delays for seeking consent is unacceptable. A prior wish about participation in clinical trials should be respected, if known. The conditions under which medical research in emergencies can be considered acceptable can be determined and agreed upon nationally and internationally. (shrink)

Clinical emergencies necessitate immediate action to avert the danger to the patient's life or health. Emergency patients might be in greatest need of novel therapies, and even presumed willing to assume some risk, but research into emergency conditions should be conducted under commonly accepted principles that fulfil the scientific, ethical, and legal criteria. Such criteria already exist in the US, but are still under development in Europe.This article introduces criteria upon which trials in emergency settings may be ethically and legally (...) justified in Europe. Based on both legal texts and professional guidelines, the author has established seven conditions for emergency research, of which informed consent and its substitutes, as well as the conditions of direct benefit requirement and necessity, are considered most problematic and therefore analysed more closely. Other conditions include absence of alternative methods, scientific validity, and approval by an ethics committee. (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)

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).

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)

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)

Awareness of the morally significant distinction between research and innovative therapy reveals serious gaps in the legal provision for compensation in the UK for injured subjects of medical research. Major problems are limitations inherent in negligence actions and a culture that emphasises indemnifying researchers before compensating victims. Medical research morally requires compensation on a no-fault basis even where there is proper consent on the part of the research subject. In particular, for drug research, there is insufficient provision (...) in the current patient guidelines of the Association of the British Pharmaceutical Industry, since they make "no legal commitment" to paying compensation for injury to patient subjects. There is a need for the provision of both adequate insurance and contractual arrangements for making payments. The solution is for Local Research Ethics Committees (LRECs) to make use of their power to withhold approval of medical research where compensation is not legally enforceable. (shrink)

As do all forms of science, medical theories have a factual as well as a logical basis. New information is presented in medical research articles. These papers have three separate arguments: the argument of the hypothesis, the argument of the experimental protocol, and the argument of the hypothesis's judgment. These arguments may be examples of the hypothetico-deductive or confirmational model of scientific inference. The logical form of these arguments are informal and inductive rather than formal and deductive. Understanding (...) the nature of the logic of the medical research article may help avoid erroneous conclusions. (shrink)

This article reinvigorates a key question in publication ethics: Is there research that it is permissible to conduct but that ought not to be published? The article raises the question in relation to two recent medical studies. It is argued that the publication of these studies may cause significant harm to individuals, that editors of medical journals have a moral responsibility for such harm, that denial of publication is inadequate as an instrument to fulfil this moral responsibility and (...) that internationally acknowledged publication ethics codes should incorporate this aspect of editors’ moral responsibility. (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)

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)

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 review system on research with human participants in the Netherlands is characterised as a decentralised controlled and integrated peer review system. It consists of an independent governmental body, the Central Committee on Research Involving Human Subjects (or Central Committee), which regulates the review of research proposals by accredited Medical Research Ethics Committees (MRECs). The legal basis was founded in 1999 with the Medical Research Involving Human Subjects Act. The review system is a decentralised arrangement since most research (...) proposal are reviewed by the 30 accredited MRECs in the country. It is a controlled system in which the Central Committee is responsible for the accreditation and oversight of the MRECs and can make legally binding directives for these committees. The assessment of research proposals is an integrated peer review process in which all documents of the research file are reviewed by experts in one committee only. A small number of research proposals are assessed by the Central Committee and not by accredited MRECs. These proposals are on specific research categories such as gene therapy, cell therapy and embryo research. The review of research with surplus human embryos is regulated separately in the Embryos Act. The Central Committee provides support to the accredited MRECs and to researchers and sponsors. It is currently developing an internet portal to reduce the bureaucracy and make the review process more efficient and transparent. The Central Committee stimulates confidence on medical research in society by providing a public trial registry with core data on reviewed research proposals. (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)

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)

The UK Medical Research Council, in order to further its mission of maintaining and improving human health, supports a substantial number of clinical trials on a wide variety of medical questions; some of these trials involve the use of placebos as controls or to maintain blinding. Before providing support, proposed trials are carefully reviewed to assess scientific quality, and to determine whether a placebo is required and is ethical — in addition to ethics review by independent Research Ethics (...) Committees. Some questions such as the choice of placebos in trials in developing countries, in surgical trials and those involving alternative medicine require consideration of additional, specific issues. Involvement of consumers in MRC work has been increasing and includes the establishment of a Consumer Liaison Group; members of this group comment on patient information leaflets for clinical trials, helping to improve patient understanding of trials and ensuring topics like placebo use are explained clearly. Views differ on the value of placebos in clinical care and on their mechanism of action; continuing research is helping to clarify the issues. (shrink)

In medical research, it is not unusual that risks are ruled out without any specification the exact risk that was ruled out. This makes it difficult to balance expected health benefits and risk of harm when choosing between alternative treatment options. International guidelines for reporting medical research results are sufficiently specific when it comes to establishing health benefits. However, there is a lack of standards for reporting on ruling out risks. We argue that transparency is needed, as in (...) the case of non-inferiority trials. The Consolidated Standards of Reporting Trials and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statements should be revised accordingly. (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...

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)

Ethical conduct is an essential component in research, especially in medical research. Statistical methods for design and analysis are powerful research tools if used properly. Abuse of these principles and methods are just as unethical as other laboratory or clinical misconduct. Inadequate research design can produce worthless results and thus wastes effort and valuable resources. For clinical research, patient resources are wasted. Inappropriate analysis of data can also produce misleading results and conclusions. For clinical research, inferior therapy might be (...) given to patients as a consequence. These ethical concerns can have implications for and affect the individuals responsible for the statistical design and analysis. Examples are provided which illustrate some possible abuses and inappropriate pressures. (shrink)

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 article examines the process of niche standardization in medical research as an example of democratizing strategies implemented in industry-funded science. I argue that niche standardization can lead to undesirable epistemic and ethical consequences, if the various goals of research are not properly aligned. I examine two examples: the case of Sarafem, approved for the treatment of premenstrual dysphoric disorder in women, and the case of BiDil, approved for exclusive use in African Americans for the treatment of congestive heart (...) failure. I conclude by cautioning against the unqualified support of democratizing strategies in industry-funded research. (shrink)

In response to the COVID-19 pandemic, there has been a rapid growth in research focused on developing vaccines and therapies. In this context, the need for speed is taken for granted, and the scientific process has adapted to accommodate this. On the surface, attempts to speed up the research enterprise appear to be a good thing. It is, however, important to consider what, if anything, might be lost when biomedical innovation is sped up. In this article we use the case (...) of a study recently retracted from the Lancet to illustrate the potential risks and harms associated with speeding up science. We then argue that, with appropriate governance mechanisms in place, it should be quite possible to both speed up science and remain attentive to scientific quality and integrity. (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)

When children are too young to make their ownautonomous decisions, decisions have to be madefor them. In certain contexts we allow parentsand others to make these decisions, and do notinterfere unless the decision clearly violatesthe best interest of the child. In othercontexts we put a priori limits on whatkind of decisions parents can make, and/or whatkinds of considerations they have to take intoaccount. Consent to medical research currentlyfalls into the second group mentioned here. Wewant to consider and ultimately reject (...) one ofthe arguments put forward for putting medicalresearch into the second category. We willargue that some objections to children'sparticipation in research are either based onan implausibly restrictive conception of whatis in fact in the child's best interests orthat there is an implicit and false premisehidden in this argument; i.e., the premise thatour children have so deeply fallen into moralturpitude that we must assume that they wouldnot want to fulfill their moral obligations,or, that they will grow up to be morallydeficient and will then wish not to have actedwell while a child. (shrink)

Race and ethnicity are commonly reported variables in biomedical research, but how they were initially determined is often not described and the rationale for analyzing them is often not provided. JAMA improved the reporting of these factors by implementing a policy and procedure for doing so. However, still lacking are careful consideration of what is actually being measured when race/ethnicity is described, consistent terminology, hypothesis-driven justification for analyzing race/ethnicity, and a consistent and generalizable measurement of socioeconomic status. Furthermore, some studies (...) continue to use race/ethnicity as a proxy for genetics. Research into appropriate measures of race/ethnicity and socioeconomic factors, as well as education of researchers regarding issues of race/ethnicity, is necessary to clarify the meaning of race/ethnicity in the biomedical literature. (shrink)

The Medical Research Council National Survey of Health and Development (NSHD) is Britain’s longest-running birth cohort study. From their birth in 1946 until the present day, its research participants, or study members, have filled out questionnaires and completed cognitive or physical examinations every few years. Among other outcomes, the findings of these studies have framed how we understand health inequalities. Throughout the decades and multiple follow-up studies, each year the study members have received a birthday card from the survey (...) staff. Although the birthday cards were originally produced in 1962 as a method to record changes of address at a time when the adolescent study members were potentially leaving school and home, they have become more than that with time. The cards mark, and have helped create, an ongoing evolving relationship between the NSHD and the surveyed study members, eventually coming to represent a relationship between the study members themselves. This article uses the birthday cards alongside archival material from the NSHD and oral history interviews with survey staff to trace the history of the growing awareness of importance of emotion within British social science research communities over the course of the 20th and early 21st centuries. It documents changing attitudes to science’s dependence on research participants, their well-being, and the collaborative nature of scientific research. The article deploys an intertextual approach to reading these texts alongside an attention to emotional communities drawing on the work of Barbara Rosenwein. (shrink)