Translational research is a buzzword which dominates discussions about the quality, the utilization, and the benefits of medical research. Yet, although translational research has become a prominent topic, no commonly agreed definition of this terminology exists. Instead, experts from different contexts such as biomedical research, clinical practice or nursing discuss translational research in multiple ways depending on how they define the problem that translational research is supposed to be the solution to. In this paper, we do not seek to (...) find a ‘correct’ definition of translational research, but instead ask how actors using this terminology for describing their own research make sense of it. To do so, we asked three questions: Which actors are engaged in the debate about translational research? What kind of different meanings of translational research exist? And, which actors refer to which meaning of translational research when using the term? In answering these questions, we highlight the role this terminology plays in defining what medical science is about today. (shrink)

Zu den elementaren Rechtfertigungsbedingungen der medizinischen Forschung an und mit Menschen zählt die informierte Einwilligungserklärung („informed consent“) des Probanden/Patienten. Für die Gewährleistung eines „informed consent“ sind dem potenziellen Studienteilnehmer u. a. qualitativ hochwertige schriftliche Aufklärungsmaterialien zur Verfügung zu stellen. Wir entwickelten eine Liste von Prüfpunkten, um mit ihnen die Qualität schriftlicher Aufklärungsmaterialien zu bestimmen und zu bewerten. Mithilfe eines Kriterienkataloges bestehend aus über 100 Prüfpunkten wurde die Qualität von 128 zufällig ausgewählten schriftlichen Aufklärungsmaterialien zu Forschungsvorhaben beurteilt, die der Ethikkommission der (...) Universität zu Lübeck im Jahr 2006 vorgelegt worden waren. Jeder Prüfpunkt ist einem von sechs Qualitätsbereichen zugeordnet (z. B. Lesbarkeit und Verständlichkeit, Nutzen-/Schadenpotenziale). Die untersuchten Aufklärungsmaterialien erfüllten im Durchschnitt die Hälfte der 117 abgefragten Qualitätskriterien, die Spannweite reichte dabei von 20 % bis 76 %. Der höchste Qualitätsscore wurde für den Bereich „Einwilligungserklärung“ beobachtet (64 % der Kriterien erfüllt), am schlechtesten schnitt der Bereich „Nutzen- und Schadenpotenziale“ ab (35 % der Kriterien erfüllt). Aufklärungsmaterialien zu klinischen Prüfungen von Arzneimitteln zeigten dabei eine signifikant höhere Qualität als die Aufklärungsmaterialien zu anderen Studientypen. Nur 21 der 117 analysierten Qualitätskriterien wurden in mehr als 80 % der einschlägigen Aufklärungsmaterialien umgesetzt. Die vorliegende Arbeit zeigt deutliche Defizite in der Qualität der untersuchten Aufklärungsmaterialien auf. Forscherinnen und Forscher benötigen Hilfestellung bei der Erstellung von Materialien, die eine informierte Entscheidung für oder gegen eine Studienteilnahme ermöglichen. Der von uns eingesetzte Kriterienkatalog könnte u. a. im Rahmen von Doktorandenseminaren dazu genutzt werden, den Blick für die Vielfalt der Anforderungen zu schärfen. (shrink)

The return of individual research results and incidental findings from biobanking research is a much debated ethical issue globally but has extensive relevance in India where the burden of out of pocket health care expenses is high for the majority. The views of 21 ethics committee (EC) members and 22 researchers from Bengaluru, India, concerning the ethics of biobanking research were sought through in‐depth interviews using an unfolding case vignette with probes. A shared view among most was that individual (...) research results which are ‘actionable’ or have ‘clinical significance’ should be returned to the sample contributors through their treating physicians. This was seen as an ethical obligation and a moral duty on the side of the researcher to “give back” to the person who contributed to the research. The challenges foreseen were that of resources, both financial and personnel, for the time and counseling needed to accompany the disclosure of results. Perceptions of ‘ownership’ appear to influence the concept of benefit sharing. While benefit sharing in financial terms was considered ethically challenging, certain researchers and ethics committee members made a case for “two way altruism” where the researcher in return for the altruistic ‘valuable contribution’, shares with the contributor/ community, benefits of the research which could include research findings, improved patient care, and more affordable access to the new diagnostic tests or products arising from the research. This defines the emerging ethic of “giving back” which goes beyond individual rights and ensures reciprocity and distributive justice. (shrink)

In this discipline-redefining book, Elizabeth T. Hurren maps the post-mortem journeys of bodies, body-parts, organs, and brains, inside the secretive culture of modern British medical research after WWII as the bodies of the deceased were harvested as bio-commons. Often the human stories behind these bodies were dissected, discarded, or destroyed in death. Hidden Histories of the Dead recovers human faces and supply-lines in the archives that medical science neglected to acknowledge. It investigates the medical ethics of organ (...) donation, the legal ambiguities of a lack of fully-informed consent and the shifting boundaries of life and re-defining of medical death in a biotechnological era. Hurren reveals the implicit, explicit and missed body disputes that took second-place to the economics of the national and international commodification of human material in global medical sciences of the Genome era. This title is also available as Open Access. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Religion and the Body in Medical ResearchCourtney S. Campbell (bio)AbstractReligious discussion of human organs and tissues has concentrated largely on donation for therapeutic purposes. The retrieval and use of human tissue samples in diagnostic, research, and education contexts have, by contrast, received very little direct theological attention. Initially undertaken at the behest of the National Bioethics Advisory Commission, this essay seeks to explore the theological and religious questions (...) embedded in nontherapeutic use of human tissue. It finds that the “donation paradigm” typically invoked in religious discourse to justify uses of the body for therapeutic reasons is inadequate in the context of nontherapeutic research, while the “resource paradigm” implicit in scientific discourse presumes a reductionist account of the body that runs contrary to important religious values about embodiment. The essay proposes a “contribution paradigm” that provides a religious perspective within which research on human tissue can be both justified and limited.The retrieval and use of human tissue samples for diagnostic, therapeutic, research, and educational purposes represent further developments in scientific study of the human body as a source of medical information. Following the completion of its examination of the ethical and policy issues pertaining to human cloning in the spring of 1997, the National Bioethics Advisory Commission (NBAC) returned to the set of questions for which it had been originally constituted, including ethical issues that arise in human subjects research. One issue that proved controversial for the human genetics subcommittee of NBAC was the scientific, philosophical, and legal status of tissue and other body parts (usually surgical specimens) that had been retrieved from patients (not research subjects) who had given general consent to the use of their body materials for research and educational purposes. The subcommittee addressed questions about the adequacy of general versus specific [End Page 275] consent, the scientific merits of identifiable versus anonymous samples and claims about patient confidentiality, and the justification for patient refusals and requests that the materials be returned to the patient or discarded rather than made available for scientific research. In an effort to better understand the ramifications of research on human tissue, the subcommittee commissioned several background papers that examined these questions from ethical, legal, research, and religious perspectives. What follows is a modified version of the report on religious considerations originally presented to the genetics subcommittee of NBAC.The central question examined in this article is whether tissue banking for purposes of research presents distinctive theological issues or prompts objections from religious communities or scholars. Religious discussion of human organs and tissues has focused largely on donation for therapeutic purposes (what I describe as the “donation paradigm”); hence, there is very little direct consideration of nontherapeutic uses of such tissue. It is possible, however, to describe implications and suggest inferences by considering (1) religious attitudes to the human body and to organs, tissues, and cells removed from the body, and (2) religious discussions of modes of transfer of body parts, such as donations, offerings, sales, and abandonment. By and large, this discussion will reflect themes that emerge from the central Western religious traditions, with some attention given to Eastern and Native perspectives.The Body: Religious Holism, Scientific Reductionism, Private PropertyThe human body as an organic totality has long been the subject of theological reflection and a symbol for religious communities. However, much less attention has been devoted to the religious status of organs, tissues, cells, and DNA. The reflection of religious scholars and communities on the status of body parts has been prompted by the necessity to confront practical questions in personal and public health and in communal life, such as justifications for surgery, autopsies, organ donation, or burial. Scientific and research interest in parts of the body can sometimes conflict with religious values about bodily integrity. Indeed, E. Richard Gold cites the “disparate claims of scientific investigation and religious belief on the body” as the exemplary case of incommensurate values regarding the body. According to Gold (1996, p. 149), “The body, from a scientific viewpoint, is a source of knowledge of physical development, aging, and disease. From a religious perspective, the body is understood [End Page 276] as a sacred object, being created in the image... (shrink)

This volume provides a comprehensive analysis of the history, development and other legal aspects relating to International Medical Law and covers issues arising from not only the physician-patient relationship, but also with many wider juridical relations involved in the broader field of medical care in the international arena.00After a general introduction, the book examines the evolution of medical law in different civilizations that existed all over the world. It systematically describes the sources of this law from conventions, (...) treaties along with discussing the important role played by the courts, international institutions and other bodies related to the medical field. The comprehensive coverage includes public health law, international spread and prevention of diseases. This volume covers medical ethics and clinical ethics; considerations to facets of the medical professionals and patients relationship such as rights and responsibilities of the physicians, beneficence, consent, privacy, rights of patients and risk management. Also covered are issues of international concern like medical criminal activities, human and drug trafficking, trade in human organs, human medical research, as well as matters dealing with bio-technology in relation to bio-safety, bio-security, bio-genetics, bio-ethics, and the role of medical personnel in armed conflicts. (shrink)

Researchers, scientists, and physicians in Uganda have become increasingly aware of the need to develop a systematic approach to reviewing bio-medical research conducted in their country. Much of this awareness and their concern stems from Uganda's high seroprevalence of human immunodeficiency virus and the consequent large influx of research monies and HIV researchers from developed countries, including the United States and Great Britain.We report on the proceedings of a five-day symposium on bioethical principles governing clinical trials, which (...) convened in Jinja, Uganda in September 1994. The thirteen male and female workshop participants included representatives from the Uganda Ministry of Health, Makerere University, the Uganda AIDS Commission, Uganda's National Council of Science and Technology, and the National Chemotherapeutic Laboratory. These representatives included ethicists, physicians, researchers, and pharmacists, all of whom have conducted research themselves. Initial workshop sessions focused on the history of human experimentation and the development of protections for human participants in medical research, both in the United States and internationally. (shrink)

There is a view, expressed by some research ethics committees and health care professionals, that research should not, under any circumstance, be performed on dying patients. This paper begins to explore current attitudes towards palliative care research, although it becomes clear that the issues discussed apply to all fields of bio-medical research. Indeed the underlying principles of autonomy, non-maleficence, beneficence and justice should apply to all groups of human subjects involved across all areas of research. The ethical principles should (...) apply equally to healthy individuals as well as to those suffering from ill health, whether this be inherited or acquired, curable or terminal. (shrink)

Today, new artistic practices incorporate scientific techniques linked to medical research that modify the body’s biological performance in vivo, transforming it into a singular laboratory object. In this way, some artists are making works of their bodies by subjecting them to various biotechnological procedures, often invasive. Augmented, the biological body of these performance artists becomes a site for experimentation. DIY (Do It Yourself) enthusiasts or accompanied by biologists and doctors, are these ‘bio-artists’ evidence of the changes brought about by (...) a new mechanisation of the human body, the complexity of which we are only just beginning to understand? Could there be, in the name of art, reasons that justify the creation of utopian bodies that are not eschatological, and that could make us believe in the worst or the best of all worlds? Based on performances by Stelarc, Yann Marussich, Marion Laval-Jeantet and the Quimera Rosa duo, our aim is to analyse what is at stake in this new fabrication of the body outside its biological limits. (shrink)

In order to maximize human performance, defence forces continue to explore, develop, and apply human performance enhancement (HPE) methods, ranging from pharmaceuticals to (bio)technological enhancement. This raises ethical, legal, and societal concerns and requires organizing a careful reflection and deliberation process, with relevant stakeholders. We discuss a range of ethical, legal, and societal aspects (ELSA), which people involved in the development and deployment of HPE can use for such reflection and deliberation. A realistic military scenario with proposed HPE application can (...) serve as a starting point for such an iterative and participatory process. Stakeholders can discuss this application, modify its features, and design appropriate processes around it – for instance, procedures for informed consent. We propose that organizing aspects into these three categories – ethical, legal, and societal – can help involve appropriate interlocutors at different moments: legal aspects with people in strategy or management roles, from the start of a project; ethical aspects with people in operations and medical roles, during development; and societal aspects with people in communication and personnel roles, during deployment. Notably, we developed and discussed this framework and the three aspects in close collaboration with personnel from the military. (shrink)

Bioethical and bio‐political questions are increasingly tackled by committees, councils, and other advisory boards that work on different and often interrelated levels. Research ethics committees work on an institutional or clinical level; local advisory boards deal with biomedical topics on the level of particular political regions; national and international political advisory boards try to answer questions about morally problematic political decisions in medical research and practice. In accordance with the increasing number and importance of committees, the quality of their (...) work and their functional status are being subjected to more and more scrutiny. Besides overall criticism regarding the quality of their work, particular committees giving political advice are often suspected of being incompatible with democratic values, such as respect for affected parties, representation of diverse values and transparency in the decision‐making processes. Based on the example of the German National Ethics Council, whose inauguration caused a still ongoing debate on the aims and scopes of committees in general, this paper discusses: (1) the requirements of modern democratic societies in dealing with complex scientific‐technical problems; (2) the composition and organisation of committees working as political advisory boards; and (3) the appointment procedures and roles of laymen and experts, and here in particular of ethicists, who may legitimately be taken on by a committee. I will argue that bioethics committees do not necessarily endanger democratic values, but can considerably improve their realisation in democratic decision‐making procedures – if, and only if, they do not act as substitutes for parliamentarian processes, but help prepare parliamentarian processes to be organised as rationally as possible. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Research Ethics after World War II: The Insular Culture of BiomedicineAllan M. Brandt (bio) and Lara Freidenfelds (bio)Human subjects research in the United States has only recently emerged as an important area of historical investigation. Over the last quarter century, scholars have begun the process of grounding within an historical context both the complex relationship between researchers and subjects and the processes by which biomedical knowledge is produced. (...) Their studies examine topics ranging from the impact of the anti-vivisectionist movement on human experimentation in the early twentieth century (Lederer 1995) to the development of the discipline of bioethics in the 1960s and 1970s (Rothman 1991) and the emergence of the legal concept of informed consent for human research (Katz, Glass, and Capron 1972). Many of the discussions focus on isolated incidents of scandal, such as the Tuskegee Syphilis Study (Jones 1993; Brandt 1978) and the Willowbrook School hepatitis study (Rothman and Rothman 1984). In doing so, they attempt to explain how such clearly unethical research could have been initiated and what consequences have resulted from public knowledge of such research.Nonetheless, the broader historical contexts and implications of human subjects research have yet to be fully delineated. This project will be of crucial importance, not only for historians, but also for those concerned with research policy and medical ethics. The historical examination of human subjects research will provide further insight into the details of research methods, the construction of protocols, and the historically specific interest in certain diseases. In addition, scholars will better understand the relationships of power and authority between researcher and subject, as well as the social and scientific mechanisms for the production of new biomedical knowledge. The process of enlisting research subjects illuminates the significance of class, gender, ethnicity, and race in science, in biomedicine, and in society. The fact that, historically, much research has employed research subjects from vulnerable populations, who participated in coercive contexts, has exposed powerful social assumptions embedded in the research enterprise. [End Page 239]The revelation of new documents indicating past abuses has sparked much of the investigation into human subjects research and the recent investigation of human radiation experiments during the Cold War era. One of the most important achievements of the Advisory Committee on Human Radiation Experiments was the uncovering of thousands of documents, a remarkable mine of archival data, that had been previously inaccessible to researchers. Jonathan Moreno and Susan Lederer’s article on the history of Cold War research ethics in this issue of the Kennedy Institute ofEthics Journal represents the first attempt since the publication of the Committee’s Final Report to analyze the Committee’s findings in a serious historical context.Historical accounts of the emergence of bioethics traditionally have left a great void in their discussions of human experimentation, generally ignoring the period between the writing of the Nuremberg Code in 1947 and the publication of Henry Beecher’s 1966 New England Journal ofMedicine article condemning systematic, unethical practices in human experimentation (Rothman 1991). The period from 1946 to 1966, however, was a time of vigorous research characterized by a fragmented community of medical researchers who applied inconsistent ethical standards and employed highly variable research practices. Both military and civilian medical researchers were intensely interested in radiation and thus conducted human subjects research along those lines, including examinations of the effects of plutonium injections and of total body irradiation, the use of trace radioisotopes to study various body processes, and observations of the effects of radiation intentionally released into the environment. The U.S. Government sponsored several thousand such studies (ACHRE 1995 [GPO, pp. 227–31; Oxford, pp. 135–38]), some of which were conducted on hospital patients, institutionalized children, military personnel, and prisoners. The Cold War scientific culture that produced this research must be examined from an historical ethical perspective.A central aspect of the culture of biomedical science after World War II was its insularity. Increasingly high standards of admission and challenging training had come to ensure that only a select group of individuals was admitted to the professions of medicine and research science. In this culture of experts, trustworthiness and ethical judgment were considered to be dependent upon expertise... (shrink)

The purpose of this chapter is to offer an ethical investigation into whether researchers have a duty to share pre-published bio-medical data with the scientific community. The central questions of the chapter are the following: do researchers have a prima facie duty to share pre-published data? And if so, what stakes and aspects of a concrete situation need to be taken into consideration in order to assess whether and to what extent researchers’ prima facie duty to (...) share data applies? We will argue that based upon their basic duties to benefit society and to promote scientific knowledge, researchers have a prima facie duty to share data. We will also argue that in order to determine whether the prima facie duty applies in practice it is indispensable to take into account the stakes of the persons concerned as well as context dependent aspects. The chapter’s overall goal is to build an analytical and ethical framework that helps to assess with regard to concrete situations whether researchers’ duty to share data applies. To this end we analyse the concept of data sharing and clarify what data sharing might imply in practice. To offer an overview of the different stakeholders’ concerns we will analyse the normative-informational environment in which data producing researchers (to whom the prima facie duty to share data applies) are usually situated. In the last step we focus on the ethically relevant context dependent aspects and illustrate how they affect researchers’ prima facie duty to share data and stakeholders’ potentially conflicting stakes. (shrink)

Magnetic resonance imaging (MRI) is an imaging technique with a rapidly expanding application range. This methodology, which relies on quantum physics and substance magnetic properties, is now being routinely used in the clinics and medical research. With the advent of measuring functional brain activity with MRI (functional MRI), this methodology has reached a larger section of the neuroscience community (e.g. psychologists, neurobiologists). In the past, the use of MRI as a biomarker or as an assay to probe tissue pathophysiological (...) condition was limited. However, with the new applications of MRI: molecular imaging, contrast‐enhanced imaging and diffusion imaging, MRI is turning into a powerful tool for in vivo characterization of tissue pathophysiology. This review focuses on the diffusion MRI. Although it only measures the averaged Brownian translational motion of water molecules, using different analysis schemes, one can extract a wide range of quantitative indices that represent tissue morphology and compartmentalization. Statistical and visualization routines help to relate these indices to biologically relevant measures such as cell density, water content and size distribution. The aim of this review is to shed light on the potential of this methodology to be used in biological research. To that end, this review is intended for the non‐MRI specialists who wish to pursue biological research with this methodology. We will overview the current applications of diffusion MRI and its relation to cellular biology of brain tissue. BioEssays 30:1235–1245, 2008. © 2008 Wiley Periodicals, Inc. (shrink)

Une éthique de la bio-médecine s'élabore depuis plus de vingt ans dans des institutions hospitalières, professionnelles ou politiques. Elle vise à protéger les droits de la personne face aux progrès de la techno-science. Elle est pluridisciplinaire et mêle aux chercheurs des penseurs de diverses familles d'esprit. Une aide à la décision est proposée aux praticiens par plusieurs méthodes : les « conférences de consensus » entre experts, les « protocoles » de soins, les « arbres décisionnels » qui connectent toutes (...) les hypothèses possibles et leurs issues prévisibles, l'évaluation médico-économique des coûts et de l'utilité des soins. L'éthique clinique qui commence à être intégrée aux études médicales s'intéresse aux décisions prises, ou à prendre, au chevet du malade. Des méthodes d'analyse de ces cas ont été mises au point, pour tenir compte, notamment, de la situation singulière, physique, mentale, sociale du patient et des modalités de l'expression de sa volonté. Ces analyses et prospectives font appel, entre autres spécialistes, au concours d’«- éthiciens », représentants des diverses « valeurs » spirituelles reconnues dans la société, qui sont souvent interrogés sur le fondement des décisions éthiques, et c'est alors que la théologie a son mot à dire.A biomedical ethics bas been developing for over twenty years in hospitals, professional groups and political committies. It’s goal is to protect an individual’s rights in face of techno-scientific progress. It is pluri-disciplinary and mixes groups of different intellectual tendencies with those wbo do research. Help in making decisions is given to practitioners by many metbods : “consensus conferences”between experts, treatment “protoco1s”, “decision trees” that connect all possible hypotheses and their foreseeable results, medico economical evaluation of the costs and utility of the treatments. Clinical ethics, which is beginning to be integrated into medical studies, concerns decisions already made or to be made by the bedside of the patient. Analytical methods of these cases bave been perfected to take into account the patient's special physical, mental, and social conditions, as well as his metbods of expressing his will. These analyses and their trends call upon representatives of diverse spiritual “values” recognized in society, among other specialists, at the gatherings of “ethicians“ wbo are often questioned about the basis of ethical decisions. This is wben theology has something to say. (shrink)

This articles considers the larger, external and the micro, internal forces that impinge on the nature and impact of contemporary research-ethics codes. The larger forces that shape the impact of codes involve the increase in public and governmental concern with privacy protection, changes within disciplines, and the rise of research entrepreneurship. In terms of micro-level forces, the article explores the continuing problems associated with the bio-medical approach to research-ethics, on-going instability for some types of social research, slippages between REBs (...) and researchers, and variability of local interpretations of ethics codes. A number of ethics-review fads also produce instability in the ethics regime. (shrink)

In the last two decades we have witnessed considerable efforts directed towards making electronic healthcare records comparable and interoperable through advances in record architectures and (bio)medical terminologies and coding systems. Deep semantic issues in general, and ontology in particular, have received some interest from the research communities. However, with the exception of work on so-called ‘controlled vocabularies’, ontology has thus far played little role in work on standardization. The prime focus has been rather the rapid population of terminologies at (...) the level of fine detail. In this paper, we argue that more efforts are needed on the side of both research and standardization to ensure that the coding systems used in electronic healthcare records enjoy a semantics that is coherent with the semantics of the record. We propose realist ontology as a method to bring about this coherence by means of a robust system of top-level ontological categories. (shrink)

ABSTRACT:Psychedelics have again become a subject of widespread interest, owing to the reinvigoration of research into their traditional uses, possible medical applications, and social implications. As evidence for psychedelics' clinical potential mounts, the field has increasingly focused on searching for mechanisms to explain the effects of psychedelics and therapeutic efficacy of psychedelic-assisted therapy (PAT). This paper reviews three general frameworks that encompass several prominent models for understanding psychedelics' effects—specifically, neurobiological, psychological, and spiritual frameworks. Following our review, the implications of (...) each framework for ethics and professional competencies in the implementation of psychedelics as medicines are explored. We suggest that interdisciplinary education may be necessary to improve communication between researchers, develop models that effectively incorporate multiple levels of analysis, and facilitate collaboration between professionals with diverse backgrounds in the implementation of psychedelic medicines. We also address pitfalls associated with overemphasis on neuro-mechanisms, risks associated with instigating vulnerable states of consciousness, and hurdles associated with the integration of spiritual frameworks in medicine. Ultimately, as psychedelics push the boundaries of explanatory frameworks focused on one level of analysis, developing new and more useful models to reflect knowledge being produced in this field should be a central aim of psychedelic science going forward. (shrink)

The biopsychosocial (BPS) model has been of considerable utility to those researching health and illness. This has been particularly the case for critical realists and those with a systemic orientation to their work. Whilst the strengths of the model are conceded in this article, its limitations are also examined. These relate to its ontological sophistication being compromised by its proneness to epistemological naivety. It is a model to explain the emergence of disease and disability, not a reflexive theory applicable to (...) the whole field of health research. This tension is linked to the emergence of a re-orientation of medical knowledge away from bio-medical reductionism. From the outset the model was not about a general critique, or a grand theory, of health and illness. Instead it was a useful intervention, on the part of medical practitioners, like George Engel and Adolf Meyer, to create a reformed medical model on behalf of their profession. Case studies of the problematics of diagnosis and medicalization are offered to illuminate the limitations of the BPS model for health researchers. (shrink)

The principle of informed consent, codified in the Declaration of Helsinki, has been widely seen as fundamental to bio-medical and research ethics. The importance of informed consent is increasing in procedures regulating the acquisition, possession and use of personal information, including genetic and medical information. Informed consent, it is believed, ensures that patients and research subjects can decide autonomously whether to permit or refuse actions that affect them. In response to this assurance, there are numerous guidelines at local, (...) national and international levels that recognise the importance of informed consent, especially in research related to healthcare in developing countries. However, complications arise in applying these guidelines to a particular situation, especially under conditions that are prevalent in developing societies, for instance in India. This article discusses common forms of impediments or hindrances encountered while exercising the principles of informed consent in the context of genetic and genomics related research among the tribal and rural caste communities in India. These hindrances include: illiteracy, poverty, paternalistic attitudes, socio-cultural barriers, ineffective regulatory mechanism and procedural inconsistency among others. The data used in this article is based on an ethnographic study conducted between December 2006 and May 2007 using social-science qualitative research techniques. We observe that three areas require attention: first, the ways in which informed public debate on bioethical issues can be held, and how the application of genetics and genomics in Indian society can be discussed; second, the readiness with which researchers, IRB members and the state appreciate and wish to map the genetic diversity in Indian society; and, third, the risks associated with the application of bioethical principles at a micro-level. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:When Should “Riskier” Subjects Be Excluded from Research Participation?*Dave Wendler** (bio)AbstractThe exclusion of potential subjects based on increased risks is a common practice in human subjects research. However, there are no guidelines to ensure that this practice is conducted in a systematic and fair way. This gap in the literature and regulations is addressed by a specific account of a “condition on inclusion risks” (CIR), a condition under which (...) potential subjects should be excluded from research on the basis of increased risks. This account provides a general framework for assessing standard exclusions as well as more controversial ones such as the exclusion of pregnant women and women of childbearing potential from certain types of research.The exclusion of potential subjects on the basis of increased risks is a common and, in most instances, noncontroversial practice in human subjects research. Investigators routinely exclude potential subjects with reduced kidney function, bleeding disorders, and allergies to the drugs under investigation. Surprisingly, this use of exclusion criteria takes place in the absence of any explicit guidelines. In the present paper, I attempt to fill this gap in the literature and regulations by offering a specific account of the conditions under which potential subjects should be excluded from research on the basis of increased risk. This account serves two purposes.First, subjects who are excluded on the basis of increased risk are prevented from making their own enrollment decisions. Therefore, it is important to ensure, in spite of the broad range of potential subjects and the varied reasons for excluding them, that potential subjects are excluded in [End Page 307] a systematic and fair way. Second, certain instances of subject exclusion, most notably the exclusion of pregnant women and women of childbearing potential, raise more difficult issues. By providing a general framework for assessing the exclusion of potential subjects based on increased risks, the present analysis covers these cases as well and, thus, offers a solution to one of the thornier ethical dilemmas facing investigators and IRBs today.Briefly, I argue that standard exclusion practices suggest that whenever two groups of potential research subjects offer the same opportunity for scientific and individual benefit, but different levels of risk, the group that would introduce greater risks should be excluded. With this framework in place, I consider potential subjects, such as men and women of child-parenting potential, whose research participation introduces increased risks to third parties. I argue that the present approach is justified, not because it reduces harms to specific individuals, but because it reduces aggregate harms. Therefore, it should be applied to all riskier potential subjects regardless of who faces the risks in question. After defending this approach, I consider several objections.First, I argue that the present approach is not paternalistic; the exclusions it calls for are not justified by what is thought to be in the best interests of the individuals excluded. Rather, the argument is that these exclusions minimize the aggregate harm of human subjects research. In addition, the present approach does not violate the obligation of researchers to respect subject autonomy because it does not reduce the number of potential subjects who are given the opportunity to enroll in a particular protocol. Finally, the exclusions are consistent with reasonable side constraints on attaining the goals of research.“Riskier” SubjectsWhen it comes to evaluating risks, most guidelines on human subjects research stipulate simply that the risks entailed must be reasonable given the potential for benefit. The Australian National Health and Medical Research Council’s guidelines, for instance, require only that “the investigator... must be satisfied that the possible advantage to be gained from the work justifies any discomfort or risk involved” (ANMRC 1992, Clause 3). To determine whether the risks of a protocol are justified, one sums the risks of the various procedures in the protocol, whatever those procedures may be, and compares the result to the procedures’ potential for benefit. This evaluation of risks assumes that the aggregate risks of a [End Page 308] given protocol are fixed and thus will not help to determine whether and when the risks of particular protocols should be reduced by excluding riskier subjects. The United States Department of Health... (shrink)

Ethical issues are of foremost importance in modern bio-medical science. Ethical guidelines and socio-cultural public awareness exist for modern samples, whereas for ancient mummy studies both are de facto lacking. This is particularly striking considering the fact that examinations are done without informed consent or that the investigations are invasive due to technological aspects and that it affects personality traits. The aim of this study is to show the pro and contra arguments of ancient mummy research from an ethical (...) point of view with a particular focus on the various stakeholders involved in this research. Relevant stakeholders in addition to the examined individual are, for example, a particular researcher, and the science community in general, likely descendents of the mummy or any future generation. Our broad discussion of the moral dilemma of mummy research should help to extract relevant decision-making criteria for any such study in future. We specifically do not make any recommendations about how to rate these decision-factors, since this is highly dependent on temporal and cultural affiliations of the involved researcher. The sustainability of modern mummy research is dependent on ethical orientation, which can only be given and eventually settled in an interdisciplinary approach such as the one we attempt to present here. (shrink)

This article examines the human placenta not only as a scientific, medical and biological entity but as a consumer bio-product. In the emergent placenta economy, the human placenta is exchanged and gains potentiality as food, medicine and cosmetics. Drawing on empirical research from the United States, the United Kingdom, Denmark and Japan, the authors use feminist cultural analysis and consumer theories to discuss how the placenta is exchanged and gains commodity status as a medical supplement, smoothie, pill and (...) anti-ageing lotion. Placenta preparers and new mothers cite medical properties and spirituality as reasons for eating or encapsulating the placenta, reinstating ideas of the liberated good mother. Meanwhile, the cosmetics industry situates the placenta as an extract and hence a commodity, re-naturalizing it as an anti-ageing, rejuvenating and whitening bio-product. The authors conclude that, in the emergent bio-economy, the dichotomy between the inner and the outer body is deconstructed, while the placenta gains clinical and industrial as well as affective value. (shrink)

The paper looks in detail at patients that were treated at one of the most discussed companies operating in the field of untried stem cell treatments, Beike Biotech of Shenzhen, China. Our data show that patients who had been treated at Beike Biotech view themselves as proactively pursuing treatment choices that are not available in their home countries. These patients typically come from a broad variety of countries: China, the United Kingdom, the United States, South Africa and Australia. Among the (...) patients we interviewed there seemed to be both an awareness of the general risks involved in such experimental treatments and a readiness to accept those risks weighed against the possible benefits. We interpret this evidence as possibly reflecting the emergence of risk-taking patients as ‘consumers’ of medical options as well as the drive of patients to seek treatment options in the global arena, rather than being hindered by the ethical and regulatory constraints of their home countries. Further, we found that these patients tend to operate in more or less stable networks and groups in which they interact and cooperate closely and develop opinions and assessments of available treatment options for their ailments. These patients also perform a multiple role as patients, research subjects, and research funders because they are required to pay their way into treatment and research activities. This new social dynamics of patienthood has important implications for the ethical governance of stem cell treatments. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:When OPRR Comes Calling:Enforcing Federal Research RegulationsCharles R. Mccarthy (bio)In an update following this article, Ruth Macklin responds to the revelation that the controversial Hall-Stillman embryo-splitting experiment at George Washington University was conducted—contrary to federal regulations—without prior institutional review board (IRB) review. This revelation altered Dr. Macklin's view of the ethical status of the research. Undoubtedly such revelations also raise general questions for administrators and researchers in many (...) institutions, including, for example: How do allegations of noncompliance with federal regulations arise? When should allegations of infractions of the regulations be reported? Who has an obligation to report? To whom should reports be made? What sort of inquiry should take place? Who should conduct the inquiry? If a determination is made that infractions have occurred, what sanctions are appropriate? And, what publicity is given to the allegations, before, during, and after an evaluation?Some of these questions can be answered in a straightforward manner, while the answers to others depend on the circumstances of the case. This article provides some general answers to these questions.1BackgroundThe Department of Health and Human Services (DHHS) is the largest supporter of biomedical and behavioral research in the world. Somewhere between 25 and 33 percent of its medical research budget is devoted to the support of research involving human subjects. In accordance with the Public Health Service Act, DHHS has issued Regulations for the Protection of Human Subjects (45 CFR 46). The DHHS Secretary has delegated responsibility for promulgating and administering the regulations to the Office for Protection from Research Risks (OPRR), which is located within the National Institutes of Health.When an institution receives an award from a DHHS agency to carry out research involving human subjects, it is required to negotiate, or to have on file, an "assurance of compliance" document that provides detailed information [End Page 51] specifying how the institution plans to comply with the regulations for the protection of human subjects. Most major research institutions in the country have on file a "multiple project assurance" (MPA) document, which extends DHHS regulations to all human subjects research conducted or sponsored by that institution, irrespective of the source of funding. The regulations and the assurance of compliance require any research project involving human subjects to be reviewed and approved by an institutional review board (IRB) prior to initiation of the research. In addition, the project must be re-reviewed by the IRB at appropriate intervals—in no case, less than once a year. Institutional compliance with these and other requirements of the regulations has improved during the last 30 years and appears to be at a high level. However, from time to time, allegations of noncompliance arise, as they did in the George Washington University embryo-splitting experiment, and set in motion the review process described below.How do Allegations of Noncompliance Arise?Allegations or indications of noncompliance with federal regulations for the protection of human subjects may come from a variety of sources. Most commonly, the institution's IRB discovers that research involving humans is going forward without the required prior IRB review and approval, or that approved research is being conducted in a way that is contrary to the stipulations of the IRB. The Hall-Stillman case came to the attention of George Washington University's IRB because the research protocol was submitted to the IRB after the research had been carried out. In this case, there could be no doubt that an infraction had occurred.Information about possible noncompliance also frequently derives from a funding agency's Initial Review Group (IRG) (commonly called a Study Section) when it has reason to suspect noncompliance in a project it is reviewing for possible funding. An actual case that occurred some years ago involved a research application that proposed to perform brain biopsies on normal volunteers. The IRG that reviewed the application lost little time in questioning whether an IRB had approved the protocol. In this case, it was not enough for the IRG to recommend disapproval of the proposal for funding; it also was obliged to report the possible infraction to OPRR.Whistleblowers, including research subjects, nurses, students, members of the... (shrink)

This paper addresses the social, cultural, and ethical dynamics of research in regenerative medicine. The author turns to both science fiction and recent developments in regenerative medicine for clues about the future of the body and medical practice, suggesting that regenerative medicine uses the body as its own resource for the purposes of preserving life, and that by attempting to remove the body from the limitations of both mortality and contingency, regenerative medicine fundamentally alters the meaning of human.

It is nearly 20 years since Tony Hope wrote an editorial in this journal on Empirical Medical Ethics,1 arguing for both a recognition of the increasing amount of work being done in ‘empirical ethics’ and for its importance as a new direction for medical ethics research. Since then empirical ethics has flourished, with debates over the role of ‘empirical’ data in ethical reasoning producing a growing body of literature and the JME and other bioethics journals regularly publishing empirical (...) studies. While bio/medical ethics has grappled with ‘incorporating’ or using more empirical data in ethical analysis, with varying degrees of success, and some criticism, there has not been a corresponding willingness of more empirical disciplines to embrace ethical analysis. This is a particular lack for applied research areas that see their role as predominately influencing policy and practice, such as health services research. Health services research ‘is the integration of epidemiological, sociological, economic, and other analytic sciences in the study of health services.’ Whose ‘main goals … are to identify the most effective ways to organize, manage, finance, and deliver high quality care; reduce medical errors; and improve patient safety’.2 Health services research brings together a wide variety of disciplines and would seem ideally placed to include ethics. However, if you search health services research journals and conference programmes there is very little consideration of ethics as a substantive topic and often scant attention paid to the ethical issues that might be raised by an intervention or policy. Ethics and ethical issues are generally confined to discussions over priority setting, and occasionally health technology assessment, with other areas of health service research seldom engaging in ethical debate. In the Encyclopaedia of Health Services Research,3 ethics …. (shrink)

It is widely agreed that social factors are related to health outcomes: much research served to establish correlations between classes of social factors on the one hand and classes of disease on the other hand. However, why and how social factors are an active part in the aetiology of disease development is something that is gaining attention only recently in the health sciences and in the medical humanities. In this paper, we advance the view that, just as bio-markers help (...) trace the causal continuum from exposure to disease development at the biological level, socio-markers ought to be introduced and studied in order to trace the social continuum from exposure to disease development. We explain how socio-markers differ from social indicators and how they can be used in combination with bio-markers in order to reconstruct the mixed mechanisms of health and disease, namely mechanisms in which both biological and social factors have an active causal role. (shrink)

We have been studying cognition and learning in research laboratories in the field of biomedical engineering. Through our combining of ethnography and cognitive-historical analysis in studying these settings we have been led to understand these labs as comprising evolving distributed cognitive systems and as furnishing agentive learning environments. For this paper we develop the theme of 'models-in-action,' a variant of what Knorr Cetina has called 'knowledge-in-action.' Among the epistemically most salient objects in these labs are so called "model systems," which (...) are designs that blend engineering with the study and use of biological systems for purposes of simulative model-based reasoning. We portray the prevalent design-orientation in this engineering specialty and how the prevailing activity of cell-culturing in these labs transitions into a design activity for the bio-medical engineers, leading them to work with 'wet' devices. We discuss how devices, 'wet' and 'dry,' situate model-based understandings and how they participate in model systems in these labs. Models tend to come in clusters or configurations, and the model systems in these labs are epistemically salient junctures of interlocking models. Model systems in these labs evolve thereby consolidating what we want to call a 'fabric of interlocking models,' which functions as point of stability and departure in these labs. We convey a taste of such a 'fabric' for a tissue-engineering lab. We conjecture that through this 'fabric' extended developments in technology and methodology have a 'situated' presence in the workings of these labs. (shrink)

Is the aim of medicine to avert death at all costs? Are doctors there to prescribe cough drops or to clamp wires on our heads? Should there be abortion on demand? What is medicine for? Vitally important decisions are today being left to an exclusive few- the Biocrats. Gerald Leach believes that there is a need now for wider discussion- informed, accurate and sensible discussion. Here he provides a survey, which has been specially updated for this Pelican edition, of such (...) fields as birth and population control, 'test-tube reproduction', eugenics and genetic engineering, mind drugs, transplants, life-propping machines.... all the fantastic realities made possible by modern bio-medicine. The author brings social, personal and legal considerations to his study and concludes by discussing which alternatives we can afford to pursue. (shrink)

Introduction. The increasing mediation of human life by medicine necessarily raises the question of philosophical understanding the phenomenon of culture medicalization, since today the vector of growing powerful influence of medicine on forming sociocultural processes has clearly emerged. Along with the positive phenomena of the medicalization of life, the volume of “excessive” phenomena of its medicalization is growing. The purpose of the article is to clarify the philo- sophical foundations of the progressive medicaliza- tion of modern culture. Methods. The methodological (...) basis of the study is presented by dialectical, epistemological, axiologi- cal, philosophical-anthropological, and socio-phil- osophical approaches. The study is based on E. Cassirer’s transcendental philosophy, the phenom- enological transcendentalism of E. Husserl; V.S. Stepin’s concept about the system of informational social codes; and P.D. Tishchenko’s concept on the transformation of bio-power in modern culture. Scientific novelty of the research. The author outlines fundamental foundations of modern cul- ture medicalization as a result of mutually similar processes of transforming bio-power and the progress of biomedical sciences. Results. Unfolding, culture compensated for the bodily weakness of a person with the power of his technical inventions, but today they have surpassed the intellectual capabilities of their creator - the individual has to permanently adapt to the grow- ing volume of mass technogenic innovations. The historically formed human need to master the world through its “humanization” is suppressed, and, as a result, the problem of a modern indi- vidual’s request for self-realization through the creative transformation of the social environment is actualized. In this regard, one of the philosophi- cal and anthropological foundations of modern culture can be recognized as a technogenically determined desire of a person to transform his own corporeality, aimed at expanding the capabili- ties of a natural person. Biomedical sciences, as a result of biotechnological progress, turned out to be exactly the social and scientific sphere, which, building up practical activities within the framework of healthcare, considers the person to be both the subject and the object of the biosocial transforma- tion demanded by cultural evolution. Conclusions. The process of medicalization of culture occurs on the basis of two reciprocal fundamental processes: first, the strengthening of the principles of bio-power as “care for all forms of life”; secondly, the progress and technologization of scientific medicine, which in practice provides a socio-cultural demand for a modern prosperous individual. (shrink)

The use of qualitative research in empirical bioethics is becoming increasingly popular, but its implementation comes with several challenges, such as difficulties in aligning moral epistemology and methods. In this paper, we describe some problems that empirical bioethics researchers may face; these problems are related to a tension between the different poles on the spectrum of scientific paradigms, namely a positivist and interpretive stance. We explore the ideas of narrative construction, ‘genres’ in medicine and dominant discourses in relation to (...) empirical research. We also reflect on the loss of depth and context that may occur with thematic or content analyses of interviews, and discuss the need for transparency about methodologies in empirical bioethics. Drawing on insights from narrative approaches in the social sciences and the clinical-educational discipline of Narrative Medicine, we further clarify these problems and suggest a narrative approach to qualitative interviewing in empirical bioethics that enables researchers to ‘listen (and read) in new ways’. We then show how this approach was applied in the first author’s research project about euthanasia decision-making. In addition, we stress the important ethical task of scrutinizing methodologies and meta-ethical standpoints, as they inevitably impact empirical outcomes and corresponding ethical judgments. Finally, we raise the question whether a ‘diagnostic’, rather than a ‘problem-solving’, mindset could and should be foregrounded in empirical ethics, albeit without losing a commitment to ethics’ normative task, and suggest further avenues for theorizing about listening and epistemic (in)justice in relation to empirical (bio)ethics. (shrink)

This article examines the global and worsening problem of research misconduct as it relates to bio-medico-legal education. While research misconduct has serious legal implications, few adequate legal remedies exist to deal with it. With respect to teaching, research ethics education should be mandatory for biomedical students and physicians. Although teaching alone will not prevent misconduct, it promotes integrity, accountability, and responsibility in research. Policies and law enforcement should send a clear message that researchers should adhere to the highest standards (...) of ethics in research. It is vital that researchers and physicians understand basic aspects of law and the legal system in order to develop understanding of the medico-legal issues not just in the legal context, but with a sound grounding in ethics, social and theoretical contexts so that they can practice good medicine. Routine and holistic research ethics education across the curriculum for medical students and resident physicians, and continuing medical education for practicing doctors, are probably the best ways to accomplish this goal. (shrink)

BackgroundThis paper discusses the contentious issue of reuse of stored biological samples and data obtained from research participants in past clinical research to answer future ethical and scientifically valid research questions. Many countries have regulations and guidelines that guide the use and exportation of stored biological samples and data. However, there are variations in regulations and guidelines governing the reuse of stored biological samples and data in Sub-Saharan Africa including Malawi.DiscussionThe current research ethics regulations and guidelines in Malawi do not (...) allow indefinite storage and reuse of biological samples and data for future unspecified research. This comes even though the country has managed to answer pertinent research questions using stored biological samples and data. We acknowledge the limited technical expertise and equipment unavailable in Malawi that necessitates exportation of biological samples and data and the genuine concern raised by the regulatory authorities about the possible exploitation of biological samples and data by researchers. We also acknowledge that Malawi does not have bio-banks for storing biological samples and data for future research purposes. This creates room for possible exploitation of biological samples and data collected from research participants in primary research projects in Malawi. However, research ethics committees require completion and approval of material transfer agreements and data transfer agreements for biological samples and data collected for research purposes respectively and this requirement may partly address the concern raised by the regulatory authorities. Our concern though is that there is no such requirement for biological samples and data collected from patients for clinical or diagnostic purposes.SummaryIn conclusion, we propose developing a medical data and material transfer agreement for biological samples and data collected from patients for clinical or diagnostic purposes in both public and private health facilities that may end up in research centers outside Malawi. We also propose revision of the current research ethics regulations and guidelines in Malawi in order to allow secondary use of biological samples and data collected from primary research projects as a way of maximizing the use of collected samples and data. Finally, we call for consultation of all stakeholders within the Malawi research community when regulatory authorities are developing policies that govern research in Malawi. (shrink)

The Swiss-born medical researcher Karl Friedrich Meyer is best known as a ‘microbe hunter’ who pioneered investigations into diseases at the intersection of animal and human health in California in the 1920s and 1930s. In particular, historians have singled out Meyer’s 1931 Ludwig Hektoen Lecture in which he described the animal kingdom as a ‘reservoir of disease’ as a forerunner of ‘one medicine’ approaches to emerging zoonoses. In so doing, however, historians risk overlooking Meyer’s other intellectual contributions. Developed in (...) a series of papers from the mid-1930s onwards, these were ordered around the concept of latent infections and sought to link microbial behavior to broader bio-ecological, environmental, and social factors that impact hostpathogen interactions. In this respect Meyer—like the comparative pathologist Theobald Smith and the immunologist Frank Macfarlane Burnet—can be seen as a pioneer of modern ideas of disease ecology. However, while Burnet’s and Smith’s contributions to this scientific field have been widely acknowledged, Meyer’s have been largely ignored. Drawing on Meyer’s published writings and private correspondence, this paper aims to correct that lacuna while contributing to a reorientation of the historiography of bacteriological epidemiology. In particular I trace Meyer’s intellectual exchanges with Smith, Burnet and the animal ecologist Charles Elton, over brucellosis, psittacosis and plague—exchanges that not only showed how environmental and ecological conditions could ‘tip the balance’ in favor of parasites but which transformed Meyer thinking about resistance to infection and disease. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Informed Consent and Clinical ResearchRuth Faden (bio)Informed consent is a powerful symbol of the commitment and impact of the new, interdisciplinary field of biomedical ethics that the Kennedy Institute has been so instrumental in developing. In the early years of biomedical ethics, there was considerable discussion about the nature of the doctor-patient relationship, about how it ought to be structured, and about how competing values within that relationship ought (...) to be accommodated. By the 1970s and 1980s, the answer was for all practical purposes in. Biomedical ethics was engaged in a clearly reformist project, in step with the values of the times, to right a wrongful imbalance of power and control between physicians and patients.The agenda was clear—to establish the moral authority of the patient to participate in medical decision making by placing respect for the autonomy of patients on the moral map of the medical community. The chief strategy that biomedical ethics adopted to accomplish this agenda was, of course, informed consent. Theories of autonomous action as well as informed consent were intentionally crafted to advance this reformist agenda.In this paper, I examine how the theory of informed consent has fared in one particular realm of “the clinic” where, arguably, there has been considerable success. This is the realm of clinical research; research at the bedside where the patient is also the subject.I rely heavily on the work of President Clinton’s Advisory Committee on Human Radiation Experiments, which I chaired. The Advisory Committee was established in response to exposés in the press about alleged secret experiments during World War II and the Cold War in which patients had been injected with plutonium without their apparent knowledge or consent. As part of its work, the Advisory Committee undertook an oral history project in which we interviewed eminent physicians about the norms and practices of human research in the 1940s and 1950s.Drawing on these interviews, I argue here for two seemingly inconsistent conclusions. First, that the ethical standards for clinical research have changed dramatically in the last 50 years—particularly with respect to informed consent. Second, that despite these important changes, the human dynamics of clinical research in many respects remain unchanged.How the World of Clinical Research Has ChangedDuring the forties and fifties, duties to obtain informed consent, whether for treatment or for research, were simply not part of the doctor-patient experience. [End Page 356]As one physician told us:In 1945, ‘50, the doctor... was king or queen. It never occurred to a doctor to ask for consent for anything. Doctors weren’t in the habit of telling the patients anything (either). They were in charge and nobody questioned their authority.(Advisory Committee on Human Radiation Experiments 1996, p. 83)This unquestioned authority extended to all decisions about the management of the patient, including whether patients were to receive experimental therapies or otherwise become the subjects of research or experimentation. Physicians were trained to be concerned with risk, and harm, and benefit, in keeping with the Hippocratic tradition. But in most institutions, the permission to try something new and to take unknown risks came, not from the patient, but from the chairman of the department.In part, this broad license reflected the very newness of scientifically grounded medical practice. In the forties and fifties, many potentially therapeutic interventions were newly discovered and in this sense considered experimental, or at least innovative. The level of uncertainty about whether a treatment would work was generally high, whether the treatment was part of a research project or not. Moreover, the formalizing of medical science at the bedside was itself still in its infancy—it was not until 1948 that the first modern clinical trial in which patients were randomized to different treatment and control groups was reported in the literature. Much of the research of this period was informal and unsystematic.Thus, it is not surprising that the physician’s authority to make treatment decisions extended to treatments that were innovative or experimental, regardless of whether these innovative treatments were the subject of formal scientific investigation. What is perhaps more surprising is that physicians often acted the same way—that... (shrink)

It is like an irony of the history of science that philosophy of chemistry emerged at a time when disciplinary research became increasingly replaced with transdisciplinary problem-orientated research. From bio-medical research via materials science to nanotechnology, chemists and chemical approaches are strongly involved in these areas. If the boundaries of the philosophies of science were to be defined by the boundaries of classical disciplines, we would not only get into demarcation troubles but also miss some of the most fascinating (...) recent research fields. One such field is the study of the dynamics of the stratosphere, which in the 1970s, by the calculations of two chemists, turned from marginality to the greatest importance to securing future conditions of life. (shrink)

The history of eugenics is getting tricky. Once regarded as an initially idealistic concept that degenerated into the monstrous Nazi race hygiene project or into an American sterilization assault against the disadvantaged and racially “inferior”, eugenics was deemed to have died after the Second World War, utterly discredited by better biological science and more enlightened social ideas. However recent research has shown that eugenics was more variegated than once thought — there were leftist and “reform” eugenists as well as “mainline” (...) or reactionary eugenists, with dedicated opposition coming more from liberal and religious quarters. Ingrained into contemporary structures and social issues such as demography, welfare, race and gender, eugenics proved more resilient and widespread than previously thought. Historians were slow to recognize its pervasive influence in Scandinavia, Latin America and Asia, where local variants evolved as adaptations to local culture and conditions. And it has persisted to the present day. In welfarist Scandinavia, eugenics has been repackaged as reproductive autonomy or “medical” measures.1 In Communist China it is alive and well in sterilization programmes and the one baby policy.2 More than this, critics allege, it has been resurrected in the “new genetics” of recent times. Geneticists have historically been strong supporters of eugenics as a way of scientifically improving the genetic quality of the human race. As I have argued in another place, during the inter-war period they failed properly to scrutinize methodologies and data used to support sterilization of mental defectives,3 and it is contendable that social and ideological factors have continued to play a role — alongside epistemic factors associated with the expansion of genetic knowledge — in. (shrink)

Definition of the problemFeminist approaches to medical ethics are well established in international discourses. By contrast, in the German-speaking medical ethical discourse, they still seem to be rather marginal. In this article, we analyze which feminist perspectives are prominent in German medical ethics and suggest new approaches.ArgumentsWe present our results from a systematized review of the literature, in which we identify existing feminist approaches within the German-speaking medical ethics discourse as well as research gaps. Based on (...) the review, our preliminary research and discussions in the working group “Feminist perspectives in bio and medical ethics”, we defend three hypotheses aimed at advancing the German feminist medical ethical discourse. We posit that (1) feminist medical ethics aim at (epistemic) justice, (2) feminist medical ethics are critical and context-sensitive, and (3) intersectional and postcolonial approaches within feminist medical ethics may contribute to epistemically just, critical, and context-sensitive medical ethics.ConclusionWe argue that feminist perspectives should be implemented as a fundamental perspective in medical ethics because they can bring together key dimensions such as epistemically just, critical, context-sensitive, intersectional, and postcolonial thinking. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Human Genome Research in an Interdependent WorldAlexander Morgan Capron (bio)This has been the year of agenda-setting conferences for the ambitious ELSI (ethical, legal and social issues) program of the Human Genome Project (HGP). But of the dozen or more major meetings of this sort held across the country, the one held at the National Institutes of Heakh (NIH) in Bethesda, MD, June 2-4, 1991, was distinctive in several respects.1As (...) its name implies, "Human Genome Research in an Interdependent World" was a global look at the issues raised by gene mapping and sequencing. Unlike previous conferences, however, this meeting looked beyond a comparative analysis of clinical and domestic legal issues, and concentrated on topics that may require responses on a truly international level if they are to be successfully resolved.The meeting's organizers gathered an impressive group of more than seventy participants from fifteen countries, including the first significant contingent of Soviet and Japanese scientists, physicians, and philosophers at an ELSI meeting. In addition to talks by the heads of the genome projects in the Soviet Union, Japan, and the United States, the meeting was keynoted by Dr. James Wyngaarden, director general of the Human Genome Organization (HUGO), and I had the honor of serving as its general chairman.The goal of the meeting was to consider an array of issues that scientists, philosophers, and lawyers from around the world suggested might have international significance, with an eye to deciding three things: (1) Does the issue deserve further attention? (2) Is the issue best addressed in an international or domestic context? and (3) Do structures exist to which the issue can be referred for resolution? In the final sessions, the entire group debated proposed resolutions on the various topics and narrowed the list needing further, intensive exploration.To provide an international framework for this process, the conference [End Page 247] established a Global Steering Committee on Ethical and Social Issues in Genome Research, which will coordinate the efforts of several task forces charged with refining the tentative resolutions adopted by the conference participants on June 4. The task forces are expected to be able to complete work on some topics by the time of the steering committee's first meeting, which was described by one participant as a "check point," probably within the coming year; on other topics, the task forces will provide interim reports and arrange to continue their analysis. Several topics—less complex or more embryonic—were referred directly to the steering committee. On all issues, a major objective will be to ascertain what existing or newly created structure or structures are capable of implementing the group's recommendations and then to monitor the issue to ensure that appropriate implementation is occurring.Issues to be Explored by Task ForcesInsurance and EmploymentWhile individuals may derive medically useful information from the expanded range of genetic tests that will flow from the HGP, they could also be harmed if test results become a basis for discrimination. An area of particular concern at the conference in Bethesda was whether genetic information should be used to decide eligibility for employment or the scope and cost of health and life insurance. The complexity of this issue is increased as barriers to worker migration fall (especially in Europe) and as more firms carry on business internationally. Furthermore, questions arise about the limits of required testing and whether individuals may decline to be informed of the results of tests.The task force will not only gather information on practices and legal standards throughout the world—especially in light of the differences among nations with regard to the linkage of employment and various forms of insurance—but will also examine international anti-discrimination laws as a possible means of supplementing domestic statutes and regulations. As a starting point, the Bethesda meeting agreed on a set of principles for the task force to refine.2ForensicsAlthough their legal status is not fully resolved, DNA tests are being used increasingly in judicial proceedings and civil and criminal investigations as a highly probative means to identify people. Most forensic uses of "DNA fingerprints" are domestic, but international cooperation among investigative bodies... (shrink)

Embryonic stem cell research holds great promise for biomedical research, but involves the destruction of human embryos. Katrien Devolder explores the tension between the view that embryos should never be deliberately harmed, and the view that such research must go forward. She provides an in-depth analysis of major attempts to resolve the problem.

Since their initial authorization by Congress in 1985, the Bio‐medical Ethics Board and its advisory body, the Biomedical Ethics Advisory Committee, have led a precarious and often politically troubled existence. Today, they are poised to take up their mandate to examine “the ethical, social, and legal implications of advances in biomedical research and technology.”.

Genetic engineering, the latest offshoot of biotech, furnishes medical sciences with an ability to design and invent living organisms as well as to observe and analyze their function However, this genetic engineering leading to process of cloning, stem-cell research and reproduction innovations, which are being heralded as new age wonders in bio-medical technology need to be contemplated with an ethical-philosophic vision to ponder over the pertinent query, Whether we are crossing thresholds into improved existence of a long and (...) very healthy living or are we metaphorically opening Pandora’s box? In my paper, I have tried to raise a few concerns that need to be deliberated upon by lawyers, policy makers, scientist, researchers, common public and academics before new life forms and world view become an actual socio-cultural reality. The queries about values and virtues in the context of the quality and dignity of life and human relationship in relation to the continued research and advancement in bio- medical technology i.e., in genetic cloning form the integral part of this paper. (shrink)

This article investigates the origins of the experiences involved in the diagnostics (detection and normative evaluation) of biological entities in image-based medical praxis. Our specific research aim presupposes a vast discussion regarding the origins of knowledge in general, but is narrowed down to the alternatives of anthropomorphism and biomorphism. Accordingly, in the subsequent chapters we will make an attempt to investigate and illustrate what holds the diagnostic experiential situation together—biological regularities, manifestation via movement, conscious synthesis, causal categories, or something (...) else. We argue that as long as knowledge originates out of practices, a promising way forward is to oscillate between the prominent although controversial ideas of the history of philosophy and observations of concrete human practices, such as, in our chosen example, image-based medical diagnostics of biological pathologies. Although a number of thinkers are involved in the discussion, Aristotle and Husserl are most important here as the representatives of historical paradigms on the matter. The body in this research was not taken solely as the physical entity (Körper) but rather as a transcendental, constitutive structure where diagnostic and biological processes synchronize in teleological movement (Leib). However, philosophical speculations are illustrated by actual radiograms, the interpretation of which brings us back to the aforementioned question of primacy regarding cognition. (shrink)

Hospitals are traditional sites, not only of care, but of knowledge production. The word ‘hospital’ is derived from ‘hospitality’, and is also associated with ‘spital’, ‘hotel’ and ‘hospice’. In medieval society, the hospice was a place of rest, security and entertainment. The Knights Hospitallers were an order of military monks that took its historical origin from a hospital founded in Jerusalem in 1048. Before the rise of the modern research hospital, these spitals had a more general function as charitable institutions (...) for the care and maintenance of the aged, infirm and impoverished. Hospitals were important in the historical emergence of the university, but with the dominance of bio-medical sciences medical faculties have become increasingly separated geographically and administratively from other faculties. Medical research is dominated by private corporations and increasingly medical knowledge exists outside the conventional procedures and norms of scientific research. (shrink)

Introduction. A man of today inevitably acquires the status of a patient in the context of preventive medicine, even when he is healthy. But at the same time, he or she becomes an object of influence both from medicine itself and from numerous social institutions and commercial structures, in addition to health institutions, which proclaimed their mission to ensure human well-being. The purpose of the study is to comprehend the philosophical and anthropological aspects of the patient’s phenomenon and clarify basic (...) foundations of transforming a patient’s consciousness in the context of progressive life medicalization. Methods. The methodological basis of the research comprises sociocultural, hermeneutic, existentialphilosophical and phenomenological approaches. The research is based on M. Heidegger’s anthropological ontology, E. Giddens’ existential ontology; M. Foucault’s concept of life medicalization; P.D. Tishchenko’s concept of transforming bio-power in modern culture. Scientific novelty of the research. The author has developed a hypothesis for the principles of forming individual and mass patient consciousness, which determines a modern person’s way of being in the context of life medicalization. Results. Suffering from the fear of the existence finiteness becomes the existential foundation of the modern patient’s consciousness, while the existential and rational foundations of the patient consciousness of the modern enlightened individual are mutually mediated. The link in their mutual mediation is believing in the possibility of achieving the ideal health, formed in modern socio-cultural conditions. In the situation of total life medicalization, in which health is understood as a prosperous existence, a special way of human being is formed on the basis of the individual patient’s consciousness. The “effect” of the life medicalization is the emergence of a mass patient consciousness - the fear of losing health forms the ideology of a medicalized society in which every individual becomes a patient. Conclusions. The progress of biomedicine is able to determine the crisis of human identity. In this regard, it is important to clarify the philosophical concepts of health and illness in the context of the modern sociocultural situation, which allows to determine the possible ideal of health within the framework of medical interventions that are safe for the human essence and capable of providing “ontological safety” when healing an individual. (shrink)

BackgroundOur human societies and certainly also (bio) medicine are more and more permeated with technology. There seems to be an increasing awareness among bioethicists that an effective and comprehensive approach to ethically guide these emerging biomedical innovations into society is needed. Such an approach has not been spelled out yet for bioethics, while there are frequent calls for ethical guidance of biomedical innovation, also by biomedical researchers themselves. New and emerging biotechnologies require anticipation of possible effects and implications, meaning (...) the scope is not evaluative after a technology has been fully developed or about hypothetical technologies, but real-time for a real biotechnology.Main textIn this paper we aim to substantiate and discuss six ingredients that we increasingly see adopted by ethicists and that together constitute “ethics parallel research”. This approach allows to fulfil two aims: guiding the development process of technologies in biomedicine and providing input for the normative evaluation of such technologies. The six ingredients of ethics parallel research are: (1) disentangling wicked problems, (2) upstream or midstream ethical analysis, (3) ethics from within, (4) inclusion of empirical research, (5) public participation and (6) mapping societal impacts, including hard and soft impacts. We will draw on gene editing, organoid technology and artificial intelligence as examples to illustrate these six ingredients.ConclusionEthics parallel research brings together these ingredients to ethically analyse and proactively or parallel guide technological development. It widens the roles and judgements from the ethicist to a more anticipatory and constructively guiding role. Ethics parallel research is characterised by a constructive, rather than a purely critical perspective, it focusses on developing best-practices rather than outlining worst practice, and draws on insights from social sciences and philosophy of technology. (shrink)