Alexis Carrel’s and Keith Porter’s accomplishments at the Rockefeller Institute for Medical Research, 1910–1950, were fundamental to the creation of the field of tissue culture.

This article concerns itself with the reception of Rous' 1911 discovery of what later came to be known as the Rous Sarcoma Virus (RSV). Rous made his discovery at the Rockefeller Institute for Medical Research which had been primarily established to conduct research into infectious diseases. Rous' chance discovery of a chicken tumor led him to a series of conjectures about cancer causation and about whether cancer could have an extrinsic cause. Rous' finding was received (...) with some scepticism by the scientific community that held that cancer was not infectious and favored explanations which located the origins of cancer in the inner mechanism of the cell. After 4 years of unsuccessful effort to isolate and further determine the virus Rous felt compelled to discontinue his work on cancer viruses. When 55 years later, the significance of Rous's discovery was attested by the award of the Nobel Prize, it opened up debates about the issues of delayed recognition and scientific reputation. This article also considers why Rous' hypothesis of a viral origin of cancer could not be incorporated into the existing body of knowledge about cancer before the 1950s. (shrink)

The Hospital of the Rockefeller Institute for Medical Research in New York City was founded on the hypothesis that direct contact with illness is a strong force in igniting the curiosity and energy that can, from time to time, lead to great leaps in our understanding of human biology and disease. This was repeatedly proven at the Hospital, a special locale where the “prepared minds” of physicians uncovered new facts that often led to effective treatments. It (...) is neither a hospital nor a laboratory, but a hospital-laboratory, which celebrated its 100th birthday in 2010. Although this was a first for America, the idea had been in the minds of European and British physician-investigators from the late 19th .. (shrink)

Shortly after bacteriologist Paul de Kruif had been dismissed from a research position at the Rockefeller Institute for Medical Research, he started contributing to a novel in collaboration with the future Nobel laureate Sinclair Lewis. The novel, Arrowsmith, would become one of the most famous satires on medicine and science. Using de Kruif’s correspondence with his idol Jacques Loeb, this paper describes the many ways in which medical science is depicted in Arrowsmith. This article (...) compares the novel with de Kruif’s and Loeb’s biographies, and focuses on the struggles of the main character, Martin Arrowsmith, as an allegory of the institutionalisation of medical research in the US, shows that Sinclair’s purpose is to caricaturise scientific work in modern medical research institutions anywhere and shows that the novel depicts a reductionist philosophy of research that seems to contradict the “messiness” of medical practice. (shrink)

This article concerns itself with the reception of Rous’ 1911 discovery of what later came to be known as the Rous Sarcoma Virus. Rous made his discovery at the Rockefeller Institute for Medical Research which had been primarily established to conduct research into infectious diseases. Rous’ chance discovery of a chicken tumor led him to a series of conjectures about cancer causation and about whether cancer could have an extrinsic cause. Rous’ finding was received with (...) some scepticism by the scientific community that held that cancer was not infectious and favored explanations which located the origins of cancer in the inner mechanism of the cell. After 4 years of unsuccessful effort to isolate and further determine the virus Rous felt compelled to discontinue his work on cancer viruses. When 55 years later, the significance of Rous’s discovery was attested by the award of the Nobel Prize, it opened up debates about the issues of delayed recognition and scientific reputation. This article also considers why Rous’ hypothesis of a viral origin of cancer could not be incorporated into the existing body of knowledge about cancer before the 1950s. (shrink)

Tobacco mosaic virus has served as a model organism for pathbreaking work in plant pathology, virology, biochemistry and applied genetics for more than a century. We were intrigued by a photograph published in Phytopathology in 1934 showing that Tabasco pepper plants responded to TMV infection with localized necrotic lesions, followed by abscission of the inoculated leaves. This dramatic outcome of a biological response to infection observed by Francis O. Holmes, a virologist at the Rockefeller Institute for Medical (...) Research, was used to score plants for resistance to TMV infection. Our objective was to gain a better understanding of early to mid-twentieth century ideas of genetic resistance to viruses in crop plants. We investigated Holmes’ observation as a practical exercise in reworking an experiment, having been inspired by Pamela Smith’s innovative Making and Knowing Project. We had a great deal of difficulty replicating Holmes’ experiment, finding that biological materials and experimental customs change over time, in ways that ideas do not. Using complementary tools plus careful study and interpretation of the original text and figures, we were able to rework, yet only partially replicate, this experiment. Reading peer-reviewed manuscripts that cited Holmes’ 1934 report provided an additional level of insight into the interpretation and replication of this work in the decades that followed. From this, we touch on how experimental reworking can inform our strategies to address the reproducibility “crisis” in twenty-first century science. (shrink)

In the early twentieth century, viruses had yet to be defined in a material way. Instead, they were known better by what they were not – not bacteria, not culturable, and not visible with a light microscope. As with the ill-defined “gene” of genetics, viruses were microbes whose nature had not been revealed. Some clarity arrived in 1929 when Francis O. Holmes, a scientist at the Boyce Thompson Institute for Plant Research reported that Tobacco mosaic virus could produce (...) local necrotic lesions on tobacco plants and that these lesions were in proportion to dilutions of the inoculum. Holmes’ method, the local lesion assay, provided the first evidence that viruses were discrete infectious particles, thus setting the stage for physicochemical studies of plant viruses. In a field where there are few eponymous methods or diseases, Holmes’ assay continues to be a useful tool for the study of plant viruses. TMV was a success because the local lesion assay “made the virus visible” and standardized the work of virology towards determining the nature of the virus. (shrink)

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

This document is designed to give guidance on assessing researchers in bioethics/medical ethics. It is intended to assist members of selection, confirmation and promotion committees, who are required to assess those conducting bioethics research when they are not from a similar disciplinary background. It does not attempt to give guidance on the quality of bioethics research, as this is a matter for peer assessment. Rather it aims to give an indication of the type, scope and amount of (...) research that is the expected in this field. It does not cover the assessment of other activities such as teaching, policy work, clinical ethics consultation and so on, but these will be mentioned for additional context. Although it mentions the UK’s Research Excellence Framework, it is not intended to be a detailed analysis of the place of bioethics in the REF. (shrink)

This book is the result of a three-year study undertaken by a multidisciplinary working party of the Institute of Medical Ethic (UK). The group was chaired by a moral theologian, and its members included biological and ethological scientists, toxicologists, physicians, veterinary surgeons, an expert in alternatives to animal use, officers of animal welfare organizations, a Home Office Inspector, philosophers, and a lawyer. Coming from these different backgrounds, and holding a diversity of moral views, the members produced the agreed (...) report as a result of detailed and rigorous discussions. The book sets out facts about animal experiments and about animal abilities to experience pain, distress and anxiety. There is a detailed examination of the moral claims related to the benefits likely to accrue from animal research, and of strategies for weighing these benefits against the harm caused to animals, in order to decide whether particular research projects ought or ought not to proceed. This leads to consideration of the statutory and non-statutory controls which safeguard standards in such research. The final section explores a variety of philosophical arguments about the use of animals in research, and offers a philosophical justification for the Working Party's more practical conclusions. Written in clear, nontechnical language, this book is accessible to lay people as well as to scientists. It is the first such document to emerge from a meeting of people with such widely differing views on this highly controversial subject, and represents a major contribution towards informing and raising the quality of contemporary debate. The book is unique in drawing together material and ideas never before found in one volume. It will interest a broad spectrum of readers, from ethicists and animal rights advocates to scientific researchers and laboratory administrators, along with general readers concerned about this compelling issue. (shrink)

BackgroundAustralian health and medical research funders support substantial research efforts, and incentives within grant funding schemes influence researcher behaviour. We aimed to determine to what extent Australian health and medical funders incentivise responsible research practices.MethodsWe conducted an audit of instructions from research grant and fellowship schemes. Eight national research grants and fellowships were purposively sampled to select schemes that awarded the largest amount of funds. The funding scheme instructions were assessed against 9 criteria (...) to determine to what extent they incentivised these responsible research and reporting practices: publicly register study protocols before starting data collection, register analysis protocols before starting data analysis, make study data openly available, make analysis code openly available, make research materials openly available, discourage use of publication metrics, conduct quality research, collaborate with a statistician, and adhere to other responsible research practices. Each criterion was answered using one of the following responses: “Instructed”, “Encouraged”, or “No mention”.ResultsAcross the 8 schemes from 5 funders, applicants were instructed or encouraged to address a median of 4 of the 9 criteria. Three criteria received no mention in any scheme. Importantly, most incentives did not seem strong as applicants were only instructed to register study protocols, discourage use of publication metrics and conduct quality research. Other criteria were encouraged but were not required.ConclusionsFunders could strengthen the incentives for responsible research practices by requiring grant and fellowship applicants to implement these practices in their proposals. Administering institutions could be required to implement these practices to be eligible for funding. Strongly rewarding researchers for implementing robust research practices could lead to sustained improvements in the quality of health and medical research. (shrink)

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

The increase in the scope of international collaborative medical research involving human subjects is raising the problem of whether and how to maintain Western ethical standards when research is conducted in countries with very different social and ethical values. Existing international ethical guidelines for research largely reflect Western concepts of human rights, focusing on the bioethical principles of respect for persons, beneficence, and justice. However, in countries and societies where these values are understood differently or are (...) not expressed in local cultures and institutions, it may be impossible or of no practical value to insert them into the research setting.In the United States, individual informed consent is considered ethically imperative for research involving human subjects. However, this imperative may be difficult to instill in societies that define persons by their relations to others, and important decisions are commonly made by heads of households or group leaders rather than by individuals. The baseline economic and health care conditions in foreign communities may also create ethical conflicts. (shrink)

The increase in the scope of international collaborative medical research involving human subjects is raising the problem of whether and how to maintain Western ethical standards when research is conducted in countries with very different social and ethical values. Existing international ethical guidelines for research largely reflect Western concepts of human rights, focusing on the bioethical principles of respect for persons, beneficence, and justice. However, in countries and societies where these values are understood differently or are (...) not expressed in local cultures and institutions, it may be impossible or of no practical value to insert them into the research setting.In the United States, individual informed consent is considered ethically imperative for research involving human subjects. However, this imperative may be difficult to instill in societies that define persons by their relations to others, and important decisions are commonly made by heads of households or group leaders rather than by individuals. The baseline economic and health care conditions in foreign communities may also create ethical conflicts. (shrink)

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

Scientists and historians have often presumed that the divide between biochemistry and molecular biology is fundamentally epistemological.100 The historiography of molecular biology as promulgated by Max Delbrück's phage disciples similarly emphasizes inherent differences between the archaic tradition of biochemistry and the approach of phage geneticists, the ur molecular biologists. A historical analysis of the development of both disciplines at Berkeley mitigates against accepting predestined differences, and underscores the similarities between the postwar development of biochemistry and the emergence of molecular biology (...) as a university discipline. Stanley's image of postwar biochemistry, with its focus on viruses as key experimental systems, and its preference for following macromolecular structure over metabolism pathways, traced the outline of molecular biology in 1950.Changes in the postwar political economy of research universities enabled the proliferation of disciplines such as microbiology, biochemistry, biophysics, immunology, and molecular biology in universities rather than in medical schools and agricultural colleges. These disciplines were predominantly concerned with investigating life at the subcellular level-research that during the 1930s had often entailed collaboration with physicists and chemists. The interdisciplinary efforts of the 1930s (many fostered by the Rockefeller Foundation) yielded a host of new tools and reagents that were standardized and mass-produced for laboratories after World War II. This commercial infrastructure enabled “basic” researchers in biochemistry and molecular biology in the 1950s and 1960s to become more independent from physics and chemistry (although they were practicing a physicochemical biology), as well as from the agricultural and medical schools that had previously housed or sponsored such research. In turn, the disciplines increasingly required their practitioners to have specialized graduate training, rather than admitting interlopers from the physical sciences.These general transitions toward greater autonomy for biochemistry and allied disciplines should not mask the important particularities of these developments on each campus. At the University of Caliornia at Berkeley, agriculture had provided, with medicine, significant sponsorship for biochemistry. The proximity of Lawrence and his cyclotrons supported the early development of Berkeley as a center for the biological uses of radioisotopes, particularly in studies of metabolism and photosynthesis. Stanley arrived to establish his department and virus institute before large-scale federal funding of biomedical research was in place, and he courted the state of California for substantial backing by promising both national prominence in the life sciences and virus research pertinent to agriculture and public health. Stanley's venture benefited significantly from the expansion of California's economy after World War II, and his mobilization against viral diseases resonated with the concerns of the Cold War, which fueled the state's rapid growth. The scientific prominence of contemporary developments at Caltech and Stanford invites the historical examination of the significance of postwar biochemistry and molecular biology within the political and cultural economy of the Golden State.In 1950, Stanley presented a persuasive picture of the power of biochemistry to refurbish life science at Berkeley while answering fundamental questions about life and infection. In the words of one Rockefeller Foundation officer,There seems little doubt in [my] mind that as a personality Stanley will be well able to dominate the other personalities on the Berkeley campus and will be able to drive his dream through to completion, which, incidentally, leaves Dr. Hubert [sic] Evans and the whole ineffective Life Sciences building in the somewhat peculiar position of being by-passed by much of the truly modern biochemistry and biophysics research that will be carried out at Berkeley. Furthermore, it seems likely that Dr. S's show will throw Dr. John Lawrence's Biophysics Department strongly in the shade both figuratively and literally, but should make the University of California pre-eminent not only in physics but in biochemistry as well.101Stanley, Sproul, Weaver, and this officer (William Loomis) all testified to a perceptible postwar opportunity to capitalize on public support for biological research that relied on the technologies from physics and chemistry without being captive to them, and that addressed issues of medicine and agriculture without being institutionally subservient. What is striking, given the expectation by many that Stanley would ‘be able to drive his dream through to completion,” was that in fact he did not. Biochemists who had succeeded in making their expertise valued in specialized niches were resistant to giving up their affiliations to joint Stanley's “liberated” organization. Stanley's failure was not simply due to institutional factors: researchers as well as Rockefeller Foundation officers faulted him for his lack of scientific imagination, which made it difficult for him to gain credibility in leading the field. Moreover, many biochemists did not share Stanley's commitment to viruses as the key material for the “new biochemistry.”In the end, Stanley's free-standing department did become a first-rate department of biochemistry, but only after freeing itself from Stanley's leadership and his single-minded devotion to viruses. Nonetheless, the falling-out with the Berkeley biochemists was rapidly followed by the establishment of a Department of Molecular Biology, attesting to the unabating economic and institutional possibilities for an authoritative “general biology” (or two, for that matter) to take hold. In each case, following Stanley's dream sheds light on how the possible and the real shaped the (re)formation of biochemistry and molecular biology as postwar life sciences. (shrink)

This essay analyzes one of Germany's former premier research institutions for biomedical research, the Kaiser Wilhelm Institute for Anthropology, Human Heredity and Eugenics (KWIA) as a test case for the way in which politics and human heredity served as resources for each other during the Third Reich. Examining the KWIA from this perspective brings us a step closer to answering the questions at the heart of most recent scholarship concerning the biomedical community under the swastika: (1) How (...) do we explain why the vast majority of German human geneticists and eugenicists were willing to work for the National Socialist state and, at the very least, legitimized its exterminationist racial policy; and (2) what accounts for at least some of Germany's most renowned medically trained professionals' involvement in forms of morally compromised science that wholly transcend the bounds of normal scientific practice? Although a complete answer to this question must await an examination of other German biological research centers, the present study suggests that during the Nazi period the symbiotic relationship between human genetics and politics served to radicalize both. The dynamic between the science of human heredity and Nazi politics changed the research practice of some of the biomedical sciences housed at the KWIA. It also simultaneously made it easier for the Nazi state to carry out its barbaric racial program leading, finally, to the extermination of millions of so-called racial undesirables. (shrink)

Throughout much of the world, universities have driven towards industrial partnerships. This collaboration, which, in the biochemical field at least, has to continue if potential benefits for patients are to be realised, has brought with it a number of problems. These include the neglect of long-term research in favour of short-term projects, the curtailing of free dissemination of research information within university departments and the biasing of results of clinical trials by the financial interests of the investigators.It is (...) very important that governments, universities, and industry itself address these problems. Universities should monitor the amount of basic, curiosity-driven research that is being carried on, compared with that which is more short-term goal orientated. PhD students and post-doctoral fellows should be exposed to the principles of bioethics early on in their careers. Further work is necessary on the terms of research contracts to protect, on the one hand, the rights of individual scientists and, on the other, industry from rogue scientists. Where problems arise, procedures should be in place for independent reviews to be conducted by bodies such as the Medical Research Council in the UK or the National Institutes of Health in the USA. The conflict-of-interest rules recently introduced for publication in medical journals should be extended to all branches of science. (shrink)

This paper considers the often-expressed fear that medical research may use children merely as means, and not respect them as ends in themselves – especially insofar as they are deemed less able to consent than adults. The main focus is on large-scale genetic, socio-medical and epidemiological research. The theoretical starting point of the paper is that to be treated as an end in oneself is to be regarded as – and to act as – a participant (...) in cooperative endeavours. This participatory status is certainly connected with individual authority to consent and dissent; and there is no doubt that consent plays an important role when adults participate in many research projects. However, insofar as consent is located within structures of human cooperation, the authority to consent is not a straightforward privilege. Rather, consent is bound up with responsibility for one's choices and commitment to shared terms of cooperation. Given this understanding, it is argued that consent should not be our principal concern when we involve children in research. This is not because of children's (possible) incompetence to consent as such, but rather because children are still learning how to respect and assess the cooperative terms involved in our institutional lives. Instead, our leading concern should be with the terms regulating their involvement in research. Given suitable safeguards, research is one way in which children may learn what it is to bear responsibilities and to act as an end in oneself – that is, to cooperate with others on reasonable terms and for worthy ends. (shrink)

Context The conduct of medical research led by Northern countries in developing countries raises ethical questions. The assessment of research protocols has to be twofold, with a first reading in the country of origin and a second one in the country where the research takes place. This reading should benefit from an independent local ethical review of protocols. Consequently, ethics committees for medical research are evolving in Africa. Objective To investigate the process of establishing (...) ethics committees and their independence. Method Descriptive study of 25 African countries and two North American countries. Data were recorded by questionnaire and interviews. Two visits of ethics committee meetings were conducted on the ground: over a period of 3 months in Kigali (Rwanda) and 2 months in Washington DC (USA). Results 22 countries participated in this study, 20 from Africa and two from North America. The response rate was 80%. 75% of local African committees developed into national ethics committees. During the last 5 years, these national committees have grown on a structural level. The circumstances of creation and the general context of underdevelopment remain the major challenges in Africa. Their independence could not be ensured without continuous training and efficient funding mechanisms. Institutional ethics committees are well established in USA and in Canada, whereas ethics committees in North America are weakened by the institutional affiliation of their members. Conclusion The process of establishing ethics committees could affect their functioning and compromise their independence in some African countries and in North America. (shrink)

The data produced by the scientific community impacts on academia, clinicians, and the general public; therefore, the scientific community and other regulatory bodies have been focussing on ethical codes of conduct. Despite the measures taken by several research councils, unethical research, publishing and/or reviewing behaviours still take place. This exploratory study considers some of the current unethical practices and the reasons behind them and explores the ways to discourage these within research and other professional disciplinary bodies. These (...) interviews/discussions with PhD students, technicians, and academics/principal investigators were conducted mostly in European higher education institutions including UK, Italy, Ireland, Portugal, Czech Republic and Netherlands.Through collegiate discussions, sharing experiences and by examining previously published/reported information, authors have identified several less reported behaviours. Some of these practices are mainly influenced either by the undue institutional expectations of research esteem or by changes in the journal review process. These malpractices can be divided in two categories relating to methodological malpractices including data management, and those that contravene publishing ethics. The former is mostly related to “committed bias”, by which the author selectively uses the data to suit their own hypothesis, methodological malpractice relates to selection of out-dated protocols that are not suited to the intended work. Although these are usually unintentional, incidences of intentional manipulations have been reported to authors of this study. For example, carrying out investigations without positive controls; but including these from a previous study. Other methodological malpractices include unfair repetitions to gain statistical significance, or retrospective ethical approvals. In contrast, the publication related malpractices such as authorship malpractices, ethical clearance irregularities have also been reported. The findings also suggest a globalised approach with clear punitive measures for offenders is needed to tackle this problem. (shrink)

Revisiting the history of postwar LSD research illuminates how the work of a chemist at the Rockefeller Institute contributed to the development of a biochemical paradigm for mental functioning. Dilworth Wayne Woolley proposed one of the first theories of the biochemistry of mental illness based on empirical evidence. His research with LSD and serotonin had wide-ranging repercussions for pharmacology and fit neatly into the emerging medicalization of mental illness. Reevaluating Woolley’s ideas and the fruits of psychopharmacology (...) leads to possible new approaches toward mental health and illness when considered alongside lessons learned from past research with psychedelic substances, and exemplifies a broader paradigm shift in cultural studies toward a biopsychosocial model that acknowledges the intersections between biology and culture. (shrink)

In recent years, to protect the rights and welfare of human subjects, institutions in the USA have begun to set up programmes to monitor ongoing medical research. These programmes provide routine, onsite oversight, and thus go beyond existing oversight such as investigating suspected misconduct or reviewing paperwork provided by investigators. However, because of a lack of guidelines and evidence, institutions have had little guidance in setting up their programmes. To help institutions make the right choices, we used interviews (...) and document analysis to study how and why 11 US institutions have set up their monitoring programmes. Although these programmes varied considerably, we were able to distinguish two general types. ‘Compliance’ programmes on the one hand were part of the institutional review board office and set up to ensure compliance with regulations. Investigators’ participation was mandatory. Monitors focused on documentation. Investigators could be disciplined, and could be obliged to take corrective actions. ‘Quality-improvement’ programmes on the other hand were part of a separate office. Investigators requested to be monitored. Monitors focused more on actual research conduct. Investigators and other parties received feedback on how to improve the research process. Although both types of programmes have their drawbacks and advantages, we argue that if institutions want to set up monitoring programmes, quality improvement is the better choice: it can help foster an atmosphere of trust between investigators and the institutional review board, and can help raise the standards for the protection of human subjects. (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)

Introduces the applications of repeated measures design processes with the popular IBM® SPSS® software Repeated Measures Design for Empirical Researchers presents comprehensive coverage of the formation of research questions and the analysis of repeated measures using IBM SPSS and also includes the solutions necessary for understanding situations where the designs can be used. In addition to explaining the computation involved in each design, the book presents a unique discussion on how to conceptualize research problems as well as identify (...) appropriate repeated measures designs for research purposes. Featuring practical examples from a multitude of domains including psychology, the social sciences, management, and sports science, the book helps readers better understand the associated theories and methodologies of repeated measures design processes. The book covers various fundamental concepts involved in the design of experiments, basic statistical designs, computational details, differentiating independent and repeated measures designs, and testing assumptions. Along with an introduction to IBM SPSS software, Repeated Measures Design for Empirical Researchers includes: A discussion of the popular repeated measures designs frequently used by researchers, such as one-way repeated measures ANOVA, two-way repeated measures design, two-way mixed design, and mixed design with two-way MANOVA Coverage of sample size determination for the successful implementation of designing and analyzing a repeated measures study A step-by-step guide to analyzing the data obtained with real-world examples throughout to illustrate the underlying advantages and assumptions A companion website with supplementary IBM SPSS data sets and programming solutions as well as additional case studies Repeated Measures Design for Empirical Researchers is a useful textbook for graduate- and PhD-level students majoring in biostatistics, the social sciences, psychology, medicine, management, sports, physical education, and health. The book is also an excellent reference for professionals interested in experimental designs and statistical sciences as well as statistical consultants and practitioners from other fields including biological, medical, agricultural, and horticultural sciences. J. P. Verma, PhD, is Professor of Statistics and Director of the Center for Advanced Studies at Lakshmibai National Institute of Physical Education, India. Professor Verma is an active researcher in sports modeling and data analysis and has conducted many workshops on research methodology, research designs, multivariate analysis, statistical modeling, and data analysis for students of management, physical education, social science, and economics. He is the author of Statistics for Exercise Science and Health with Microsoft® Office Excel®, also published by Wiley. (shrink)

Throughout much of the world, universities have driven towards industrial partnerships. This collaboration, which, in the biochemical field at least, has to continue if potential benefits for patients are to be realised, has brought with it a number of problems. These include the neglect of long-term research in favour of short-term projects, the curtailing of free dissemination of research information within university departments and the biasing of results of clinical trials by the financial interests of the investigators. It (...) is very important that governments, universities, and industry itself address these problems. Universities should monitor the amount of basic, curiosity-driven research that is being carried on, compared with that which is more short-term goal orientated. PhD students and post-doctoral fellows should be exposed to the principles of bioethics early on in their careers. Further work is necessary on the terms of research contracts to protect, on the one hand, the rights of individual scientists and, on the other, industry from rogue scientists. Where problems arise, procedures should be in place for independent reviews to be conducted by bodies such as the Medical Research Council in the UK or the National Institutes of Health in the USA. The conflict-of-interest rules recently introduced for publication in medical journals should be extended to all branches of science. (shrink)

Background Regardless of national contexts, the institutions responsible for research ethics, founded on international regulations, are all expected to be structured and to operate in a common way. Our experience with several countries on different continents, however, has raised questions in this regard. This article examines the differences and structural weaknesses of ethics committees in four countries where we have conducted the same socio-anthropological study in the field of reproductive health. Methods In addition to recording our observations during field (...) surveys for this study, we performed a documentary review and interviewed expert members of ethics committees, research participants, and researchers who had experience with requesting ethics approvals for research protocols in the field of social sciences and health. Results The results of this study showed that, despite having the same mandate, the committees functioned differently, while they all exhibited the same weaknesses. Thus, the universalization and standardization of institutional conditions for applying ethical standards in research still present problems that are, at the very least, relevant. Conclusion This study on ethics committees in four countries demonstrated the profound influence of context on the ways in which different institutions function and enforce regulations. In effect, in all social fields, every innovation is infused by its context. (shrink)

The consideration of racial differences in the biology of disease and treatment options is a hallmark of modern medicine. However, this time-honored medical tradition has no scientific basis, and the premise itself, that is, the existence of biological differences between the commonly known races, is false inasmuch as races are only sociocultural constructions. It is time to rid medical research of the highly damaging exercise of searching for supposed racial differences in the biological manifestations of disease. The (...) practice not only condoned but required by the National Institutes of Health of utilizing racial identification as a demographic characteristic with assumed biological implications is at best badly flawed, and at worst unintentionally contributes to perpetuating the fallacy of natural differences between persons of different skin color, which has been used in the past to advance the cause of racial discrimination. (shrink)

Conflicts of interest have been reduced to financial conflicts. The National Institutes of Health’s new rules for managing conflicts of interest in medical research, the first major change to the regulations in over 15 years, address only financial ties. Although several commentators urged that the regulations also cover non-financial interests, the Department of Health and Human Services declined to do so. Similarly, the Institute of Medicine’s influential 2009 Conflict of Interest Report focuses almost exclusively on financial conflicts. (...) Institutional policies at academic medical centers and guidance from professional bodies and medical journals also primarily emphasize financial ties. Even broadly worded rules are applied more readily to financial ties than non-financial interests, such as the regulations that restrict institutional review board members with conflicting interests from participating in protocol reviews. (shrink)

BackgroundThe SARS-CoV-2 pandemic has highlighted once more the great need for comprehensive access to, and uncomplicated use of, pre-existing patient data for medical research. Enabling secondary research-use of patient-data is a prerequisite for the efficient and sustainable promotion of translation and personalisation in medicine, and for the advancement of public-health. However, balancing the legitimate interests of scientists in broad and unrestricted data-access and the demand for individual autonomy, privacy and social justice is a great challenge for patient-based (...) medical research.MethodsWe therefore conducted two questionnaire-based surveys among North-German outpatients (n = 650) to determine their attitude towards data-donation for medical research, implemented as an opt-out-process.ResultsWe observed a high level of acceptance (75.0%), the most powerful predictor of a positive attitude towards data-donation was the conviction that every citizen has a duty to contribute to the improvement of medical research (> 80% of participants approving data-donation). Interestingly, patients distinguished sharply between research inside and outside the EU, despite a general awareness that universities and public research institutions cooperate with commercial companies, willingness to allow use of donated data by the latter was very low (7.1% to 29.1%, depending upon location of company). The most popular measures among interviewees to counteract reservations against commercial data-use were regulation by law (61.4%), stipulating in the process that data are not sold or resold (84.6%). A majority requested control of both the use (46.8%) and the protection (41.5%) of the data by independent bodies.ConclusionsIn conclusion, data-donation for medical research, implemented as a combination of legal entitlement and easy-to-exercise-right to opt-out, was found to be widely supported by German patients and therefore warrants further consideration for a transposition into national law. (shrink)

While many "benchtop-to-bedside" research pathways have been developed in "Type I" translational medicine, vehicles to facilitate "Type II" and "Type III" translation that convert scientific data into clinical and community interventions designed to improve the health of human populations remain elusive. Further, while a high percentage of physicians endorse the principle of citizen leadership, many have difficulty practicing it. This discrepancy has been attributed, in part, to lack of training and preparation for public advocacy, time limitation, and institutional resistance. (...) As translational medicine and physician-citizenship implicate social, political, economic and cultural factors, both enterprises require "integrative" research strategies that blend insights from multiple fields of study, as well as rhetorical acumen in adapting messages to reach multiple audiences. This article considers how argumentation theory's epistemological flexibility, audience attentiveness, and heuristic qualities, combined with concepts from classical rhetoric, such as rhetorical invention, the synecdoche, and ethos, yield tools to facilitate translational medicine and enable physician-citizenship. (shrink)

The Neuroscience Institute of Schizophrenia and Allied Disorders’s “Gift of Hope” Tissue Donor Program is a volunteer programme for people who wish to donate their brain when they die for neuroscience research into schizophrenia. Organ donation for purposes of research differs from transplant donation in a number of ways, most notably the absence of a single recipient. Within a particular community, however, the single recipient is replaced by a sense of shared experience and preventing suffering in others. (...) Donors have an investment in the research. (shrink)

The Research Excellence Framework of the Higher Education Funding Council for England is taking place in 2013, its three key elements being outputs, impact, and “quality of the research environment”. Impact will be assessed using case studies that “may include any social, economic or cultural impact or benefit beyond academia that has taken place during the assessment period.”1 Medical ethics in the UK still does not have its own cognate assessment panel—for example, bioethics or applied ethics—unlike in, (...) for example, Australia. Several researchers in medical ethics have reported to the Institute of Medical Ethics that during the internal preliminary stage of the Research Excellence Framework several medical schools have decided to include only research that entails empirical data gathering. Thus, conceptual papers and ethical analysis will be excluded. The arbitrary exclusion of reasoned discussion of medical ethics issues as a proper subject for medical research unless it is based on empirical data gathering is conceptually mistaken. “Empirical ethics” is, of course, a legitimate component of medical ethics research, but to act as though it is the only legitimate component suggests, at best, a partial understanding of the nature of ethics in general and medical ethics in particular. It also mistakenly places medicine firmly on only one side of the science/humanities “two cultures” divide instead of in its rightful place bridging the divide. Given the emphasis by the General Medical Council on medical ethics in properly preparing “tomorrow’s doctors,” we urge medical schools to find a way of using the upcoming Research Excellence Framework to highlight the expertise residing in their ethicist colleagues. We are confident that appropriate assessment will reveal work of high quality that can be shown to have social and cultural impact and benefit beyond academia, as required by the framework. (shrink)

This study explores how qualitative health researchers navigate the demands of medical research ethics committees in Germany where qualitative research is subject to approval only when it is conducted in medical contexts. We present the results of a grounded theory study to investigate qualitative health researchers’ experiences with procedural ethics and the strategies they adopt to navigate its demands. Our analysis revealed six dimensions of experience and three strategies adopted by researchers to navigate the demands of (...) medical research ethics committees. All participants agreed that research ethics is of high importance in qualitative health research, but strategies to navigate the demands of medical research ethics committees ranged from avoiding, and adapting, to transforming the procedures of ethics review. Based on our findings, we provide recommendations for improving the ethics review of qualitative health research. (shrink)

“Wicked” problems are characterized by intractable complexity, uncertainty, and conflict between individuals or institutions, and they inhabit almost every corner of medical ethics. Despite wide acceptance of the same ethical principles, we nevertheless disagree about how to formulate such problems, how to solve them, what would _count_ as solving them, or even what the possible solutions _are_. That is, we don’t always know how best to implement ethical ideals in messy real-world contexts. I sketch an implementation framework for (...) class='Hi'>medical ethics that can help clarify wicked problems and organize further ethics research toward their resolutions. This framework describes the procedural variables that work alongside substantive ethical ideals to deliver ethical decisions in complex real-world situations. Using controversial GM mosquito research as an example, I illustrate how the generalizable relationships between the variables clarify emerging ethical guidelines of research governance and provide a pathway to extend these guidelines in a way consistent with our ethical intuitions across a wide range of research and public health ethics. (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)

In calling for the transformation of military medical education and training, the 2005 Base Realignment and Closure Commission recommended relocating basic and specialty enlisted medical training to a single site to take advantage of economies of scale and the opportunity for joint training. As a result, a joint medical education and training campus (METC) has been established at Fort Sam Houston, Texas. Two of METC's primary long-term goals are to become a high-performing learning organization and to seek (...) accreditation as a community college. Such goals require a clear model of organizational improvement with well-defined metrics for measuring its performance and using research and evaluation to assess and improve that performance. Lessons learned from a review of practices at institutions with similar missions -- such as community colleges, corporate universities, the UK's Defence Medical Education and Training Agency, and other federal agencies, such as the Veterans Health Administration -- establish a clear need for an office of institutional research to help METC attain its organizational goals. They also provide useful recommendations regarding the METC office's structure, scope, and governance. (shrink)

Statistical evidence is pervasive in medicine. In this chapter we will focus on the reliability of randomized clinical trials (RCTs) conducted to test the safety and efficacy of medical treatments. RCTs are scientific experiments and, as such, we expect them to be replicable: if we repeat the same experiment time and again, we should obtain the same outcome (Norton 2015). The statistical design of the test should guarantee that the observed outcome is not a random event, but rather a (...) real effect of the treatments administered. However, for more than a decade now, we have been discussing a replicability crisis across different experimental disciplines including medicine: the outcomes of trials published in very prestigious journals often disappear when the experiment is repeated (see, e.g., Lehrer 2010, Begley and Ellis 2012, Horton 2015). -/- There are different accounts of the reason for this replicability crisis, ranging from scientific fraud to lack of institutional incentives to double-check someone else’s results. In this chapter we will use the replicability crisis as a thread to introduce some central issues in the design of scientific experiments in medicine. First, in section 1, we will see how replicability and statistical significance are connected: we can only make sense of the p-value of a trial outcome within a series of replications of the test. But in order to conduct these replications properly, we need to agree on the proper design of the experiment we are going to repeat. In particular, we need to prevent the preferences of the experimenters from biasing the outcome of the experiment. If there is such a bias, when the experiment is replicated by a third party, the observed outcome will vanish. In section 2, we will argue that trialists need to agree on the debiasing procedures and the statistical quality controls that feature in the trial protocol, if they want the outcome to be replicable. In section 3, we will make two complementary points. On the one hand, replicability per se is not everything: we need trial outcomes that are not only statistically significant but also clinically relevant. On the other hand, trials are not everything: the experts analyzing the evidence can improve the reliability of statistical evidence, although they sometimes fail; we need to further study how they make their decisions. In section 4, we will use a controversy about the overprescription of statins to show how non-replicable effects are obtained in trials and how experts may fail at detecting such flaws, if the commercial interests are big enough. (shrink)

BackgroundResearch using data from medical care promises to advance medical science and improve healthcare. Academia is not the only sector that expects such research to be of great benefit. The research-based health industry is also interested in so-called ‘real-world’ health data to develop new drugs, medical technologies or data-based health applications. While access to medical data is handled very differently in different countries, and some empirical data suggest people are uncomfortable with the idea of (...) companies accessing health information, this paper aims to advance the ethical debate about secondary use of medical data generated in the public healthcare sector by for-profit companies for medical research (ReuseForPro).MethodsWe first clarify some basic concepts and our ethical-normative approach, then discuss and ethically evaluate potential claims and interests of relevant stakeholders: patients as data subjects in the public healthcare system, for-profit companies, the public, and physicians and their healthcare institutions. Finally, we address the tensions between legitimate claims of different stakeholders in order to suggest conditions that might ensure ethically sound ReuseForPro.ResultsWe conclude that there are good reasons to grant for-profit companies access to medical data if they meet certain conditions: among others they need to respect patients’ informational rights and their actions need to be compatible with the public’s interest in health benefit from ReuseForPro. (shrink)

In When Clinical Trials Compete: Prioritizing Study Recruitment, Gelinas et al tackle an important issue—study non-completion—and draw conclusions with which we largely agree. Most importantly, we accept that setting priorities among competing research studies is necessary and should be informed by ethical analysis. We disagree with the conclusion of Gelinas et al that this priority setting should take place at the level of the individual research institution. At a minimum, they should consider other actors who might be better (...) suited for this role instead of—or alongside—the institutions that host research. Our view is motivated by three main considerations. First, research institutions have significant latitude to promote their own interests, and there is reason to suspect that their interests do not closely align with the interests of the public. Thus, asking research institutions to set research priorities may result in the selection of studies with suboptimal social value. Second, a large proportion of clinical trials recruits participants at multiple institutions.1 If each institution sets its own priorities, we can expect discrepancies between the priorities set by partner institutions. These discrepancies may delay and discourage collaborative research projects. Finally, we suspect that a great deal of recruitment competition occurs between, rather than within, research institutions. Setting priorities only at …. (shrink)

BackgroundLarge-scale, centralized data repositories are playing a critical and unprecedented role in fostering innovative health research, leading to new opportunities as well as dilemmas for the medical sciences. Uncovering the reasons as to why citizens do or do not contribute to such repositories, for example, to population-based biobanks, is therefore crucial. We investigated and compared the views of existing participants and non-participants on contributing to large-scale, centralized health research data repositories with those of ex-participants regarding the decision (...) to end their participation. This comparison could yield new insights into motives of participation and non-participation, in particular the behavioural change of withdrawal.MethodsWe conducted 36 in-depth interviews with ex-participants, participants, and non-participants of a three-generation, population-based biobank in the Netherlands. The interviews focused on the respondents’ decision-making processes relating to their participation in a large-scale, centralized repository for health research data.ResultsThe decision of participants and non-participants to contribute to the biobank was motivated by a desire to help others. Whereas participants perceived only benefits relating to their participation and were unconcerned about potential risks, non-participants and ex-participants raised concerns about the threat of large-scale, centralized public data repositories and public institutes, such as social exclusion or commercialization. Our analysis of ex-participants’ perceptions suggests that intrapersonal characteristics, such as levels of trust in society, participation conceived as a social norm, and basic societal values account for differences between participants and non-participants.ConclusionsOur findings indicate the fluidity of motives centring on helping others in decisions to participate in large-scale, centralized health research data repositories. Efforts to improve participation should focus on enhancing the trustworthiness of such data repositories and developing layered strategies for communication with participants and with the public. Accordingly, personalized approaches for recruiting participants and transmitting information along with appropriate regulatory frameworks are required, which have important implications for current data management and informed consent procedures. (shrink)

Research ethics training during post-graduate education is necessary to improve ethical standards in the design and conduct of biomedical research. We studied quality and quantity of research ethics training in the curricula of post-graduate programs in the medical science in I.R. Iran. We evaluated curricula of 125 post-graduate programs in medical sciences in I.R. Iran. We qualitatively studied the curricula by education level, including the Master and PhD degrees and analyzed the contents and the amount (...) of teaching allocated for ethics training in each curriculum. We found no research ethics training in 72 of the programs. Among the 53 programs that considered research ethics training, only 17 programs had specific courses for research ethics and eight of them had detailed topics on their courses. The research ethics training was optional in 25% and mandatory in 76% of the programs. Post-graduate studies that were approved in the more recent years had more attention to the research ethics training. Research ethics training was neglected in most of the medical post-graduate programs. We suggest including sufficient amount of mandatory research ethics training in Master and PhD programs in I.R. Iran. Further research about quality of research ethics training and implementation of curricula in the biomedical institutions is warranted. (shrink)

BackgroundAs moral case deliberations (MCDs) have increasingly been implemented in health care institutions as a form of ethics support, it is relevant to know whether and how MCDs actually contribute to positive changes in care. Insight is needed on what actually happens in daily care practice following MCD sessions. This study aimed at investigating the impact of MCD and exploring how ‘impact of MCD’ should be conceptualized for future research.MethodsA multiple-case study was conducted in a care organization for people (...) with intellectual disabilities and/or acquired brain injury, by observing MCD sessions as ‘cases’, followed by interviews with health care professionals concerning the follow-up to these cases, and a focus group with involved MCD facilitators. A conceptual scheme concerning the possible impact formed the basis for analysis: (1) individual moral awareness; (2) the actions of health care professionals; (3) collaboration among health care professionals; (4) the concrete situation of the client; (5) the client’s quality of care and life; (6) the organizational and policy level.ResultsAccording to interviewees, their moral awareness and their collaboration, both among colleagues and with clients’ relatives, improved after MCD. Perceived impact on client situation, quality of care/life and the organizational level varied among interviewees or was difficult to define or link to MCD. Three aspects were added to the conceptual scheme concerning the impact of MCD: (a) preparations and expectations prior to the MCD session; (b) a translational step between the conclusions of the MCD session and practical events in the following period, and (c) collaboration with clients’ relatives. A negative impact of MCD was also found on misunderstandings among participants and disappointment about lack of follow-up.ConclusionsConcretizing and conceptualizing the ‘impact’ of MCD is complicated as many factors play a role either before or during the transition from MCD to practice. It is important to consider ‘impact’ in a broad sense and to relate it to the goals and context of the MCD in question. Future studies in this field should pay additional attention to the preparations, content and process involved in ethics support, including clients’ and relatives’ experiences. (shrink)

The case study presented by Winch and Sinnott (2011) shows not only how difficult it is for clinicians and researchers to identify conflicts of interest (COI), but also how damaging it can be when there are unin- formed and uncoordinated policy responses by senior administrators.