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...

American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recommendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium's Pediatrics Working Group compared these recommendations, focusing on operational and ethical issues specific to decision making for children. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locus of decision making, as well as the risks and benefits of testing, and (2) whether the guidelines (...) conflict or come to different but compatible conclusions because they consider different testing scenarios. These statements differ in ethically significant ways. AAP/ACMG analyzes risks and benefits using best interests of the child and recommends that, absent ameliorative interventions available during childhood, clinicians should generally decline to order testing. Parents authorize focused tests. ACMG analyzes risks and benefits using the interests of the child and other family members and recommends that sequencing results be examined for additional variants that can lead to ameliorative interventions, regardless of age, which laboratories should report to clinicians who should contextualize the results. Parents must accept additional analysis. The ethical arguments in these statements appear to be in tension with each other. (shrink)

The rapidly changing field of genetics affects society through advances in health-care and through implications of genetic research. This study addresses the impacts of new genetic discoveries and technologies on different segments of today's society. The book begins with a chapter on genetic complexity, and subsequent chapters discuss moral and ethical questions arising from today's genetics from the perspectives of health care professionals, the media, the general public, special interest groups and commercial interests.

Medicine's crucial concern with health is perennial, but its reflection, concepts, means change with the advance of science and social life. We present here a fascinating panorama of current medical discussions with their philosophical underpinnings, and queries as they have evolved from the past. The role of Tymieniecka's phenomenology of life is brought forth as the system of philosophical reference.

The main varieties of scientific misconduct are fabrication, falsification, misquoting and plagiarism. Considering the "improvement" of fraudulent skills, scientists, editors, and authorities must jointly combat the misconduct. Also, it is important that whistleblowers must be protected from revenge. The response to scientific misconduct requires national and international bodies to provide leadership and guidelines. Whistleblowers need a safe, confidential place to report misconduct. The quality of research and hidden conflicts of interest should be taken into account deciding which studies are (...) to be included into reviews. Forged publications and speculative theories have been used for promotion of drugs, dietary supplements and treatments without proven effectiveness. Marketing of placebos in the guise of evidence-based medications seems to be on the increase. Patients can be misinformed not only by the advertising but also by publications supposed to be scientific. Furthermore, it has become usual practice to disregard published criticism in spite of personal communications and debates at conferences. Some scientists seem to make use of critical comments without citing them, or just continue publications ignoring the criticism. The same scientists continue working sometimes in cooperation with renowned researchers; and it is possible that some later articles are more reliable than earlier ones. However, it is insufficient to hope that reliable publications would be shortly confirmed while forgeries would fall into oblivion. Fake papers are misleading for research and practice, cost time and money. Wrong concepts are persisting and reappearing, which may result in useless experimentation and application of invasive methods without sufficient indications. An international cooperation of bona fide scientists, editors and authorities is needed to eradicate the scientific misconduct and fraude in medicine. The book contains an overview of misconduct in medical research and practice mainly from the former Soviet Union. Ample documentary evidence is provided as illustrations. (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)

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)

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)

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)

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 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)

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.

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)

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)

BackgroundIn Morocco, medical research ethics training was integrated into the medical curriculum during the 2015 reform. In the same year, a law on medical research ethics was enacted to protect individuals participating in medical research. These improvements, whether in the reform or in the enactment of the law, could positively impact the knowledge of these researchers and, consequently, their attitudes and practices regarding medical research ethics. The main objective of this work (...) is to assess Moroccan physicians’ knowledge, attitudes, and practices at the beginning of their careers (interns and residents) in medical research ethics.Patients and methodsThis is a multicenter cross-sectional study conducted in 2021 among Moroccan physicians. Three scores were created and validated to assess physicians’ level of knowledge, attitudes, and practices regarding research ethics. A descriptive analysis was carried out, followed by a univariate analysis and a multivariate analysis using multivariate binary logistic regression to study the factors associated with the different calculated scores.ResultsA total of 924 physicians were included in the study, with an average age of 27.8 ± 2.2 years. 40.7% had a high medical research ethics knowledge score, and 68.8% had good attitudes. These two scores were positively associated with age and were statistically higher in residents and in physicians who had received training in medical research ethics during their medical curriculum. Only 29,9% of physicians who had participated in research studies had adequate practices with medical research ethics. This score was statistically higher in residents and in physicians who had heard about research ethics.ConclusionA genuine introduction to ethics in the medical curriculum is essential to enhance researchers’ knowledge, attitudes, and practices. This, in turn, can lead to an increase in both the quantity and quality of research conducted in Morocco. (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)

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).

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)

For today, the medical association came to common opinion, that a doctor-scientist cannot be higher than the universal values. At a decision-making, equally with the scientific interests, which, undoubtedly, will bring to development of the theoretical and practical medicine, a doctor must take into account moral values. The doctrine of the informed consent of patient that is examined as a necessary condition of any medical interference became ethic basis of experiment with participation of human. An observance of confidentiality (...) of the results of the studies is also very important. The present development of the biomedical knowledge supposes realization of human research in a good cause, after the conducted tests on the animals and the other models. A clinical test on human must take place only then, when the risk does not exceed the benefit. Carrying out of the biomedical studies is considered as illegal, unconscionable, amoral and even criminal action. If the regulations and the norms of the law are not observed, it entails penal offence. This article provides the basic foundations of medical activities rather moral standards of medical and research activity, which in the different periods underwent the changes dictated by moral requirements of an era and society are analyzed. (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)

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)