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)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- (...) cause the research involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

Research question and aimClinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020,...

Fifty years after the death of Edmund Husserl, the main founder of the phenomenological current of thought, we present to the public a four book collection showing in an unprecedented way how Husserl's aspiration to inspire the entire universe of knowledge and scholarship has now been realized. These volumes display for the first time the astounding expansion of phenomenological philosophy throughout the world and the enormous wealth and variety of ideas, insights, and approaches it has inspired. The basic commitment to (...) phenomenological concerns found in all this variety makes this collection a most signifi cant historical document. This second volume of the collection bears witness to a deliberate shift of attention from the earlier to the later phase of Husserl's reflections. We see how his issues - intersubjectivity, ethics, human encounter, the societal world, empathy, the sphere of the self, and the surpassing of dichotomies (bodylpsyche, etc.) - are now at the center of attention in the human sciences. Among the authors are H. Tellenbach, A. Rigobello, C. Balzer, C. Bjurvill, V. Molchanov, E. Syristova, O. Balaban, R. Boehm, M. Sancipriano, O. M. Anwar, Y. Okamoto, B. Holyst, T. Sodeika, and M. De Negri. The studies were gathered at the programs held by The World Institute for Advanced Phenomenological Research and Learning in the commemorative year 1988/1989, chiefly at the First World Congress of Phenomenology at Santiago de Compos tela, Spain, with the aim of assessing the current state of phenomenology. A-T. T. (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...

Name der Zeitschrift: Jahrbuch für Wissenschaft und Ethik Jahrgang: 20 Heft: 1 Seiten: 237-240.

This book is a comprehensive and unique text and reference in medical ethics. By far the most inclusive set of primary documents and articles in the field ever published, it contains over 100 selections. Virtually all pieces appear in their entirety, and a significant number would be difficult to obtain elsewhere. The volume draws upon the literature of history, medicine, philosophical and religious ethics, economics, and sociology. A wide range of topics and issues are covered, such as law (...) and medicine, truth-telling by the physician, research, population policy, genetics, abortion, dying, and individual rights in medical care. The selections span the centuries, beginning with material from the works of Hippocrates, continuing through Thomas Percival, John Stuart Mill, and Claude Bernard, down to modern commentators like Henry K. Beecher, Walsh McDermott, David L. Bazelon, Paul Freund, H. L. A. Hart, John Rawls, Paul Ramsey, Richard McCormick, Rashi Fein, and Bernard Barber. The text has eight major divisions, beginning with sections on the ethical dimensions of the physician-patient relationship in history; the moral bases of medical ethics; and regulation, compulsion, and protection of the consumer in clinical medicine and public health. Each of these sections includes key essays that appear for the first time. All of the book's major divisions contain primary documents: codes such as the Hippocratic Oath, Medieval Law for the Regulation of Medicine, and the first as well as the most recent code of the American Medical Association; court decisions, including those on Karen Quinlan and on abortion in the United States and West Germany; government documents such as the statement of the National Commission on the Protection of Human Subjects, the Tuskegee Syphilis Report, the British Parliamentary debate on euthanasia, and the Council of Europe on rights of the sick and dying; and various published guidelines such as the Harvard Medical School brain death criteria, the American Hospital Association on patient's rights, and Pope Pius XII on the prolongation of life. Cases that illustrate moral dilemmas are provided for discussion purposes. Each section is preceded by a succinct editor's introduction. The documents and essays are of practical value for practitioners and students in medicine, law, ethics, and counselling, and for individual patients and groups concerned with medical care. Through encompassing divergent viewpoints, the essays and primary documents were selected to encourage humane practices and deepen understanding of the multiple traditions that shaped and do shape the development of medicine. (shrink)

"The Bush administration and Congress are in concert on the goal of developing a fleet of unmanned aircraft that can reduce both defense costs and aircrew losses in combat by taking on at least the most dangerous combat missions. Unmanned combat aerial vehicles (UCAVs) will be neither inexpensive enough to be readily expendable nor-- at least in early development-- capable of performing every combat mission alongside or in lieu of manned sorties. Yet the tremendous potential of such systems is widely (...) recognized, and allies as well as potential adversaries are moving quickly to mount their own research and development programs. The United States is committed to fielding UCAV capabilities by 2010, principally for the missions of suppression of enemy air defense and deep strike, which are among the highest risk tasks for the Air Force and naval aviation."--Overview. (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.

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in (...) the wrong direction. The aim of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

Researchers seeking to engage in projects related to Tribal communities and their citizens, lands, and non-human relatives are responsible for understanding and abiding by each Tribal nation’s research laws and review processes. Few studies, however, have described the many diverse forms of Tribal research review systems across the United States (US). This study provides one of the most comprehensive examinations of research review processes administered by Tribal Research Review Boards (TRRBs) in the US. Through a systematic (...) analysis, we consider TRRBs’ online presence, online documentation, and themes across documents, for five entity types: Tribal nations and Tribal consortiums, Tribal colleges and universities, Tribal health organizations, Indian Health Services, and other Tribal organizations. Results include an assessment of online presence for 98 potential TRRBs, identification of 118 publicly available online documents, and analysis of 41 themes across four document types: Tribal research codes and TRRBs’ guidelines, applications, and post-approval documents. Altogether, this research provides a macro-level analysis of the most common types of TRRBs in the US in an effort to increase researchers’ understanding of these important processes as they prepare to ethically engage Tribal communities in research. These results aim to empower Tribal decision makers as they align their TRRBs’ online visibility and documentation with community priorities and strengthen their protections for the rights and wellbeing of their citizens and community. Ultimately, by expanding our knowledge of TRRBs across the US, this contribution seeks to uphold Tribal sovereignty in research and promote ethical approaches to research with Indigenous communities. (shrink)

Research Ethics in Applied Economics Emphasizing the new challenges posed by the data science revolution, digital media, and changing standards, Research Ethics in Applied Economics examines the ethical issues faced by the applied economics researcher at each stage of the research process. The first section of the book considers project development, including issues of project management, selection bias in asking research questions, and political incentives in the development and funding of research ideas. The (...) second section addresses data collection and analysis, discussing concerns about participant rights, data falsification, data management, specification search, p-hacking, and replicability. The final section focuses on sharing results with academic audiences and beyond, with an emphasis on self-plagiarism, self-promotion, and the importance of achieving policy impact. The discussion and related recommendations highlight emergent issues in research ethics. Featuring case studies from experienced researchers on how they address ethical issues, this book provides practical guidance to both students and experienced practitioners seeking to navigate ethical issues in their applied economics research. (shrink)

The application of artificial intelligence and machine learning technologies in healthcare have immense potential to improve the care of patients. While there are some emerging practices surro...

Despite their clearly demonstrated safety and effectiveness, approved vaccines against COVID-19 are commonly mistrusted. Nations should find and implement effective ways to boost vaccine confidence. But the implications for ethical vaccine development are less straightforward than some have assumed. Opponents of COVID-19 vaccine challenge trials, in particular, made speculative or empirically implausible warnings on this matter, some of which, if applied consistently, would have ruled out most COVID-19 vaccine trials and many non-pharmaceutical responses.

The researcher : researching and developing ourselves -- The participant : responsibility, care and consideration -- Relational ethics : the relationship between the researcher and the participant -- Establishing trust : the fundamental ingredients -- Research dilemmas, decisions and details -- Research ethics committees : structures and procedures -- The social and political contexts of research and the ethics of dissemination.

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the (...) wrong direction. The aim of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

As the artificial intelligence (AI) ethics field is currently working towards its operationalisation, ethics review as carried out by research ethics committees (RECs) constitutes a powerful, but so far underdeveloped, framework to make AI ethics effective in practice at the research level. This article contributes to the elaboration of research ethics frameworks for research projects developing and/or using AI. It highlights that these frameworks are still in their infancy and in need (...) of a structure and criteria to ensure AI research projects advance in a way that respects norms and principles. This article proposes to draw from the European Union’s AI Act currently in development to shape these frameworks. Although, in the current form of the draft (as of August 2023), the obligations of the AI Act do not apply to scientific research, it is most likely that they will still have a strong impact on AI research considering the need to anticipate market placement or to test new tools in real world conditions. This article investigates what the risk-based approach in the AI Act implies for research ethics and highlights some AI Act obligations of particular value to implement for ethics review processes. (shrink)

This research focuses on how research ethics committee and integrity board members discuss and decide on solutions to case scenarios that involve a dimension of research ethics or integrity in collaborative settings. The cases involved issues around authorship, conflict of interest, disregard of good scientific practice and ethics review, and research with vulnerable populations (children and neonates). The cases were set in a university, a hospital, or a research institute. In the (...) class='Hi'>research, we used a deductive qualitative approach with thematic analysis. Twenty-seven research ethics committee and research integrity board members from 16 European countries and one country outside Europe participated. Participants represented natural and life sciences, social sciences, and humanities. They worked on cases involving ethical/integrity issues in six different constellations. Results show that experts apply key elements of ethical decision making, namely identification of ethical issues, stakeholders, guidelines, solutions, and own positionality, in dealing collaboratively with ethics/ integrity problems, and the nature of the application depends on the complexity of the case. Understanding how individuals knowledgeable in research ethics and integrity, in this case, individuals serving on research ethics committees and integrity boards, approach ethical/ moral issues can help to identify strategies that may be useful in the development of research ethics and integrity training for junior researchers who may benefit from learning professional strategies. (shrink)

While empirical studies of research ethics and integrity are increasingly common, few have aimed at national scope, and even fewer at current results from Central and Eastern Europe. This article introduces the results of the first national research integrity survey in Estonia, which included all research-performing organisations in Estonia, was inclusive of all disciplines and all levels of experience. A web-based survey was developed and carried out in Estonia with a call sent to all accredited Estonian (...) research institutions. The results indicate that the vast majority (89%) of respondents consider research ethics and integrity issues important and view falsification, fabrication, and plagiarism (FFPs) as the most severe forms of misconduct. Self-reporting of FFPs is generally comparable to levels published in other studies (6.2%). Gift authorship (41%) and hampering the work of a colleague (32%) were problematic practices most noticed among colleagues. At the same time, two of the noticed questionable research practices (QRPs) – salami-slicing and misuse of research funding – were seen as less severe, hinting at the existence of counter-norms that career advancement rules and structural factors like funding policies may encourage. The availability of research ethics and integrity guidelines was considered good. Ethical aspects of studying potentially stigmatising data in a very small research community are discussed in the article and results are analysed through counter-norms and normative dissonance frames. (shrink)

The Johns Hopkins‐Fogarty African Bioethics Training Program (FABTP) has offered a fully‐funded, one‐year, non‐degree training opportunity in research ethics to health professionals, ethics committee members, scholars, journalists and scientists from countries across sub‐Saharan Africa. In the first 9 years of operation, 28 trainees from 13 African countries have trained with FABTP. Any capacity building investment requires periodic critical evaluation of the impact that training dollars produce. In this paper we describe and evaluate FABTP and the efforts of (...) its trainees.Our data show that since 2001, the 28 former FABTP trainees have authored or co‐authored 105 new bioethics‐related publications; were awarded 33 bioethics‐related grants; played key roles on 78 bioethics‐related research studies; and participated in 198 bioethics workshops or conferences. Over the past nine years, trainees have collectively taught 48 separate courses related to bioethics and have given 170 presentations on various topics in the field. Many former trainees have pursued and completed doctoral degrees in bioethics; some have become editorial board members for bioethics journals. Female trainees were, on average, less experienced at matriculation and produced fewer post‐training outputs than their male counterparts. More comprehensive studies are needed to determine the relationships between age, sex, previous experience and training program outputs. (shrink)

This article talks about both clinical research ethics and public health research ethics. Clinical research ethics are defined as set of relevant ethics considered necessary for the conduct of clinical trials in field of the clinical research. While public health research ethics is mainly aimed at finding out what is best for the communities and the populations rather than the individuals. Research ethics is mainly focused on the protection (...) of individual participants and some of the research norms and accepted principles may be challenging when applying in some of the research contexts. (shrink)

The role of research ethics committees, and research ethics issues more broadly are often not viewed in the context of the development of scientific methods and the academic community. This topic piece seeks to redress this gap. I begin with a brief outline of the changes we experience within the social sciences before exploring in more detail their impact on research ethics and the practices of research ethics committees. I conclude with recommendations (...) for how the existing research ethics processes may be made more future-proof. (shrink)

Clinical research ethics consultation has emerged in the last 15 years as a service to those involved in the conduct of clinical research who face challenging issues for which more than one course of action may be justified. To respond to a growing field and need for opportunities to share knowledge and experience, the Clinical Research Ethics Consultation Collaborative, established in 2014, holds monthly webinars for its 90 members to present their most challenging cases to (...) each other and engage in substantive discussion. Every year, the group selects the four most interesting cases with accompanying commentaries for publication in the American Journal of Bioethics. This timely book brings together these cases and commentaries under a range of common themes for the first time, creating a permanent collection in book format that encourages and supports readers to gain a better understanding of the ethical challenges that they may face, and providing them with a convenient and reflective resource to reference in their own deliberations. Key Features- Comprehensive collection of cases and commentaries, chosen to reflect the range of issues faced by clinical researchers and oversight committees and illustrate the diversity of analysis that can arise. Supplemented by short introductions to each section. Focus on ethical rather than regulatory issues. Essential Reading for graduate students in bioethics and post-doctoral bioethics fellows, and useful for all participants in training grants that are funded by either NIH or NSF Presenting challenging cases to stimulate reflection, the book provides invaluable guidance to clinicians in training and in practice and to investigators, bioethics consultants, regulators, and oversight bodies. (shrink)

The Polish equivalents of Research Ethics Committees are Bioethics Committees (BCs). A questionnaire study has been undertaken to determine their situation. The BC is usually comprised of 13 members. Nine of these are doctors and four are non-doctors. In 2006 BCs assessed an average of 27.3 ± 31.7 (range: 0–131) projects of clinical trials and 71.1 ± 139.8 (range: 0–638) projects of other types of medical research. During one BC meeting an average of 10.3 ± 14.7 (range: (...) 0–71) projects of medical research were assessed (2006). The amendment of Polish laws according with Directive 2001/20/EC caused a percentage increase in BCs which assessed less than 20 projects per year (16% vs. 33% or 42% in 2003 vs. 2005 or 2006 respectively, p < 0,05). The results confirm the usefulness of the current practice of creating BCs by medical universities, medical institutes and regional chambers of physicians and dentists but rationalization of the workload for individual BCs is necessary. (shrink)

This chapter examines the explicit and implicit roles that the concept of beneficence plays in the guidelines that govern biomedical research involving humans. We suggest that the role beneficence is actually playing in the guidelines is more comprehensive than is commonly assumed. The broader conceptualisation of beneficence proposed here clarifies the relationship of beneficence to respect for autonomy. It does this by showing how respect for autonomy is at the service of beneficence rather than in tension with it.

The ethics review of qualitative health research poses various challenges that are due to a mismatch between the current practice of ethics review and the nature of qualitative methodology. The process of obtaining ethics approval for a study by a research ethics committee before the start of a research study has been described as “procedural ethics” and the identification and handling of ethical issues by researchers during the research process as “ (...) class='Hi'>ethics in practice.” While some authors dispute and other authors defend the use of procedural ethics in relation to qualitative health research, there is general agreement that it needs to be supplemented with ethics in practice. This article aims to provide an illustration of research ethics in practice by reflecting on the ways in which we identified and addressed ethical and methodological issues that arose in the context of an interview study with mental health service users and relatives. We describe the challenges we faced and the solutions we found in relation to the potential vulnerability of research participants, the voluntariness of consent, the increase of participant access and the heterogeneity of the sample, the protection of privacy and internal confidentiality, and the consideration of personal and contextual factors. (shrink)

Background: Concern has been expressed about the process of consent to clinical trials, particularly in phase I “first-in-man” trials. Trial participant information sheets are often lengthy and technical. Content-based readability testing of sheets, which is often required to obtain research ethics approval for trials in the USA, is limited and cannot indicate how information will perform. Methods: An independent-groups design was used to study the user-testing performance of the participant information sheet from the phase I TGN1412 trial. Members (...) of the public were asked to read it, then find and demonstrate understanding of 21 key aspects of the trial. The participant information sheet was then rewritten, redesigned and tested on 20 members of the public, using the same 21-item questionnaire. Results: On the original TGN1412 participant information sheet, participants could not find answers and some of the found information was not understood. Six of 21 questions, including those relating to placebo, follow-up visits and the emergency phone number, were found by eight or fewer of 10 participants. The revised information sheet performed better, with the answers to 17 of 21 questions found and understood by all 20 participants. Conclusions: Tests showed that the TGN1412 participant information sheet may not inform participants adequately for consent. Revising its content and design led to significant improvements. Writers of materials for trial participants should take account of good practice in information design. Performance-based user testing may be a useful method to indicate strengths and weaknesses in trial materials. (shrink)

Research ethics is an integral part of research, especially that involving human subjects. However, concerns have been expressed that research ethics has come to be seen as a procedural concern focused on a few well-established ethical issues that researchers need to address to obtain ethical approval to begin their research. While such prospective review of research is important, we argue that it is not sufficient to address all aspects of research ethics. (...) We propose retrospective review as an important complement to prospective review. We offer two arguments to support our claim that prospective review is insufficient. First, as currently practiced, research ethics has become for some a ‘tick box’ exercise to get over the ‘hurdle’ of ethics approval. This fails to capture much of what is important in ethics and does not promote careful reflection on the ethical issues involved. Second, the current approach tends to be rules-based and we argue that research ethics should go beyond this to develop people’s capacity to be sensitive to the relevant moral features of their research, their ethical decision-making skills and their integrity. Retrospective review of a project’s ethical issues, and how they were addressed, could help to achieve those aims better. We believe that a broad range of stakeholders should be involved in such retrospective review, including representatives of ethics committees, participating communities and those involved in the research. All stakeholders could then learn from others’ perspectives and experiences. An open and transparent assessment of research could help to promote trust and understanding between stakeholders, as well as identifying areas of agreement and disagreement and how these can be built upon or addressed. Retrospective review also has the potential to promote critical reflection on ethics and help to develop ethical sensitivity and integrity within the research team. Demonstrating this would take empirical evidence and we suggest that any such initiatives should be accompanied by research into their effectiveness. Our article concludes with a discussion of some possible objections to our proposal, and an invitation to further debate and discussion. (shrink)

Hofmann and Holm’s recent survey on issues of research misconduct with PhD graduates culminated with a notable conclusion by the authors: ‘ Scientific misconduct seems to be an environmental issue as much as a matter of personal integrity’. Here, we re-emphasise the usefulness of an education-based countermeasure against toxic research environments or cultures that promote unethical practices amongst the younger researchers. We posit that an adequately conducted course in research ethics and integrity, with a good dose (...) of case studies and analyses, can function in a manner that is metaphorically akin to vaccination. The training would cultivate the ability to analyse and build confidence in young researchers in making decisions with sound moral reasoning as well as in speaking up or arguing against pressure and coercions into unacceptable behaviour. A sufficiently large number of young researchers exposed to research ethics trainings would essentially provide a research community some degree of lasting herd immunity at its broadest base. Beyond passive immunity, a crop of research ethics-savvy young researchers could also play active and influential roles as role models for others at their level and perhaps even help correct the wayward attitudes of some senior researchers and initiate prompt action from institutional policy makers in a bottom-up manner. (shrink)

With the recent Clinical Trials Directive, a degree of harmonisation into research ethics committees across Europe, including the time taken to assess a trial proposal and the kinds of issues a committee should take into account, has been introduced by the European Union . How four different member states—Hungary, Portugal, Sweden and the UK—have chosen to implement the directive is shown. Although this has resulted in four very different ways of structuring RECs, similar themes are present in all (...) four cases, such as centralisation of control over RECs within member states, harmonisation of REC procedures across the EU and increased role of political decision making with regard to such committees. (shrink)