Researching two different work settings, police work and hospice care, the authors experienced a strange sense of discomfort in their bodies during their fieldwork when investigating professional training and work situations, especially in encounters with citizens and patients. In some of those situations, the authors withdrew physically or mentally from the situation without wanting to do so, feeling emotionally affected by the uncertainty of the situations, not fully grasping the meaning of what was going on. In a strange way they (...) felt awkwardly detached from their research activities and their bodily involvement in their fieldwork. In this article, the authors seek to explore the meaning of awkwardness embedded in some kinds of ethical dilemma. Through a phenomenological analysis based on the concept of intentionality of the body and a model of inner dilemmas, they reach a renewed understanding on the phenomenon of awkwardness as a natural way for researchers to respond to challenging fieldwork situations. Finally, they propose and unfold mutual interviewing and cooperative analysis as methods of investigating researcher's subjectivity in facing such situations. (shrink)

Alzheimer’s disease is a very common, progressive and still incurable disease. Future possibilities for its cure lie in the promotion of research that will increase our knowledge of the disorder’s causes and lead to the discovery of effective remedies. Such research will necessarily involve individuals suffering from Alzheimer’s disease. This raises the controversial issue of whether patients with Alzheimer’s disease are competent to give their consent for research participation.

This paper addresses the growing concern over violation of research ethics in marketing, in particular rights of human subjects in fieldwork, notably the right to informed consent; right to privacy and confidentiality; and right not to be deceived or harmed as a result of participation in a research. The paper highlights the interaction of the three main parties involved in most marketing research: the sponsoring organization (client or user), researcher, and participant in the survey, focusing on researcher’s ethical responsibilities (...) in interacting with human subjects in surveys. The paper stresses the importance of ethical integrity in marketing research and emphasizes the need to establish a universal model for regulatory requirements and well institutionalized practice of ethical research. (shrink)

Purpose. With the consideration of anthropological tendencies in modern science, the purpose of the article is to analyze the problem of the subject of cognition, philosophical-psychological rationale for the need to complement it by the concept of "the researcher’s personality". Theoretical basis. The authors rely on post-non-classical methodological tools and basic principles of complexity theory, as well as theoretical provisions of epistemological constructivism, the results of theoretical and empirical psychological studies. In them, authors revealed psychological features of the potential (...) of self-realization of a person prone to innovation and research activities and transfessionalism, including the resources and reserves of the researcher’s personality. Originality. The concept of the subject of cognition is expanded by the concept of "researcher’s personality" and derivative concepts that describe the dynamics of self-harmonization of originative co-generative strengths and opportunities of self-realization of an enlightened person, reveal the degree of correlation in the cognition of the subjective and objective dimensions of his life. It is substantiated that further analysis of the problem of anthropologization of science requires appropriate onto-epistemological grounds that reveals the unity of cognition-education-skill as an essential characteristic of the maturity of the researcher’s personality of scientific knowledge. Conclusions. In the context of anthropological shifts in modern science, the philosophical-psychological analysis of the problem of the subject of cognition is actualized. The psychological research proves the advisability of using the "researcher’s personality" concept as a basic one for understanding the formation of an enlightened human-creator, capable of auto-eco-organization, self-transcendence, and syzygy with the Universe at different levels of innovational research activity. The self-realization of the researcher-personality is a way-search for the authenticity of the multiform unity of life, the personal meaning of scientific truth, and the self-harmonization of the originative co-generative co-determinative strengths in the knowledge of an enlightened person. Including the concept of the subject of cognition in the ontology of the unity of difference-multidimensional poly-essential autopoetic integrity, the anthropologization of science is intended to revive the ancient idea in the unity of truth, education and skill of a scientist, defining the ideal of a modern human-transfessional. (shrink)

As we aggressively pursue research to cure and prevent Alzheimer’s disease, we encounter important ethical challenges. None of these challenges, if handled thoughtfully, would pose insurmountable barriers to research. But if they are ignored, they could slow the research process, alienate potential study subjects and do damage to research recruits and others. These challenges are the necessity of very large cohorts of research subjects, recruited for lengthy studies, probably ending only in the subjects’ death; the creation of cohorts of ’study (...) ready' volunteers, many of whom will be competent to consent at the beginning of the process, but move into cognitive impairment later; reliance on adaptive trial design, creating challenges for informed consent, equipoise and justice; the use of biomarkers and predictive tests that describe risk rather than certainty, and that can threaten participants’ welfare if the information is obtained by insurance companies or long-term care providers; the use of study partners that creates unique risks of harm to the relationship of subject and study partner. We need greater attention, at all levels, to these complex ethical issues. Work on these issues should be included in research plans, from the federal to the local, and should be supported through NIH in the same way that it supported work on the ethical, legal and social implications of genetic research. (shrink)

The question of how to become and remain an effective leader has been discussed for decades, and the answers that have been proposed have led to numerous theories and taxonomies of leadership behavior. By taking a critical approach to a contemporary integrative model of leadership behavior, this theoretical research proposes an alternative approach that can supplement both the integrative model and current leader–member exchange theory. Our approach is sensitive to both objective and subjective aspects of leadership behavior. We argue that (...) perceptions of leadership behavior are influenced by interpersonal relations and contextual variables in an organization. We further argue that multilevel aspects must be investigated to understand leadership behavior and that the perceptions thereof shape and are shaped by relations and contextual variables. A distinct methodological approach based on mixed methods is then proposed to better understand what influences perceptions of leadership behavior. The article discusses the conceptual, epistemological, and methodological consequences of studying leadership behavior and perceptions of such behavior. (shrink)

Drawing on accounts of the author's personal responses while undertaking a qualitative study on the norms governing the relationship between nurses and mothers, it is argued that such responses, rather than being seen as a source of bias, have the potential to be a source of insight and interpretation in the research. This paper tells the ‘inside’ story of previously published research that was ‘sanitized’ by the omission of any reference to die researcher's subjective responses. The recognition of such researcher (...) responses has implications for how research is supervised and presented. (shrink)

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

In the United Kingdom, there are moves to extend formal ethical review of research involving human subjects beyond the traditional oversight by NHS local or multi-centre research ethics committees of medical or clinical research, to also encompass all ‘non-clinical’ research involving human subjects. This paper describes and analyses the development and implementation of a model for ethical review within the university sector. At Cardiff University, a devolved or two-tiered system of ethics review has been created in which a top-level university (...) research ethics committee provides policy advice to and oversight of school-based research ethics committees that engage in formal ethics review of research conducted in their respective schools. We describe the system and reflect on the challenges and benefits of implementing such a coordinated and comprehensive university-wide system of ethics review. (shrink)

In his paper “Scientific research is a moral duty”, John Harris argues that individuals have a moral duty to participate in biomedical research by volunteering as research subjects. He supports his claim with reference to what he calls the principle of beneficence as embodied in the “rule of rescue” , and the principle of fairness embodied in the prohibition on “free riding” . His view that biomedical research is an important social good is agreed upon, but it is argued that (...) Harris succeeds only in showing that such participation and support is a moral good, among many other moral goods, while failing to show that there is a moral duty to participate in biomedical research in particular. The flaws in Harris’s arguments are detailed here, and it is shown that the principles of beneficence and fairness yield only a weaker discretionary or imperfect obligation to help others in need and to reciprocate for sacrifices that others have made for the public good. This obligation is discretionary in the sense that the individuals are free to choose when, where, and how to help others in need and reciprocate for earlier sacrifices. That Harris has not succeeded in claiming a special status for biomedical research among all other social goods is shown here. (shrink)

Dr. Henry Beecher, a renowned Harvard Medical School anesthesiologist, sent shock waves through the medical research community and the lay press when he described 22 examples of “unethical or questionably ethical studies” by reputable researchers at major institutions in his now well-known 1966 New England Journal of Medicine article. Beecher concluded this exposé by noting: “The ethical approach to experimentation in man has several components: two are more important than the others, the first being informed consent.... Secondly, there is the (...) more reliable safeguard provided by the presence of an intelligent, informed, conscientious, compassionate, responsible investigator”. Beecher’s... (shrink)

Researchers do not owe their subjects the same level of care that physicians owe patients, but they owe more than merely what the research protocol stipulates. In keeping with the dynamics of the relationship between researcher and subject, they have limited but substantive fiduciary obligations.

International health-related research on human subjects entails unique ethical responsibilities and difficulties. Often, these difficulties are augmented by the lack of a local ethical review infrastructure. In a recent cross-national study conducted by us, three critical components of ethical regulation were identified—external oversight, local oversight and subject involvement—and integrated into the study design. These three concepts are outlined and established as an important aspect of ensuring ethical coherence in the local context, particularly when reviews by the local institutional review boards (...) cannot practically be obtained. The three levels of ethical oversight identified are suggested to be the framework within which future field studies on human subjects are developed and a standard for maintaining ethical rigorousness in research on humans. (shrink)

The article examines a number of methodological and conceptual features in the philosophical work of S.L. Rubinstein of the early (Marburg) period. It is assumed that the copies of Rubinstein’s doctoral inaugural dissertation available at the university of Marburg (Germany) and it the private archive of K.A. Abulkhanova represents two parts of one research, which understated expect in it’s first part (the text submitted for defense) an interpretation and criticism of Hegel’s absolute rationalism, and in the second part an exposition (...) of the author’s own concept. It is proved that Rubinstein overcomes the logical limitation the Hegelian philosophical absolutization – the opposition of being and consciousness, the author fuses object and subject in a single being as a domain of accommodation of both, the construction of the internal consistent picture of being as the actual being of a leaving subject. Acknowledgement of Sources. The author is sincerely grateful to the D. Sc. in Philosophy, Professor, Academician of the Russian Academy of Education K.A. Abulkhanova for the materials provided from her personal archive. (shrink)

This article addresses the complex reflections regarding gender relations expressed by women active in the contemporary Islamic revival movements in Europe (especially France and Germany). Much recent research conducted among these groups aims to counter the rather negative accounts prevailing in public discourses on gender and Islam. This literature notably argues that women's conscious turn to Islam is not necessarily a reaffirmation of male domination, but that it constitutes a possibility for agency and empowerment. However, when faced with certain ‘traditionalist’ (...) positions defended by these women, even this well-meaning literature seems precarious, left in a state of uncertainty. Taking this puzzlement as a point of departure, this contribution aims to think about the dilemmas involved in articulating a language for women's dignity and self-realization, which competes with dominant languages of equality, individual rights and autonomy. This project is rendered even more intricate by the fact that these pious Muslim women socialized in Europe have also been partly fashioned by the liberal discourses against which they want to position themselves. (shrink)

No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...) have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (shrink)

Much of the human research conducted in the United States or by U.S. researchers is regulated by the Common Rule. The Common Rule reflects the decision of 17 federal agencies, including the Department of Health and Human Services, to require that investigators follow the same rules for conducting human research., though there is significant overlap with the Common Rule.) Many of the obligations delineated in the Common Rule can be traced back to the work of the National Commission for the (...) Protection of Human Subjects of Biomedical and Behavioral Research. The National Commission was appointed in 1974 as part of the National Research Act in response to revelations about serious abuses involving human subjects, most notably the Tuskegee/United States Public Health Service Syphilis Study. (shrink)

BackgroundAn increasing number of studies utilize intracranial electrophysiology in human subjects to advance basic neuroscience knowledge. However, the use of neurosurgical patients as human research subjects raises important ethical considerations, particularly regarding informed consent and undue influence, as well as subjects’ motivations for participation. Yet a thorough empirical examination of these issues in a participant population has been lacking. The present study therefore aimed to empirically investigate ethical concerns regarding informed consent and voluntariness in Parkinson’s disease patients undergoing deep brain (...) stimulator (DBS) placement who participated in an intraoperative neuroscience study.MethodsTwo semi-structured 30-minute interviews were conducted preoperatively and postoperatively via telephone. Interviews assessed participants’ motivations for participation in the parent intraoperative study, recall of information presented during the informed consent process, and participants’ postoperative reflections on the research study.ResultsTwenty-two participants (mean age = 60.9) completed preoperative interviews at a mean of 7.8 days following informed consent and a mean of 5.2 days prior to DBS surgery. Twenty participants completed postoperative interviews at a mean of 5 weeks following surgery. All participants cited altruism or advancing medical science as “very important” or “important” in their decision to participate in the study. Only 22.7% (n = 5) correctly recalled one of the two risks of the study. Correct recall of other aspects of the informed consent was poor (36.4% for study purpose; 50.0% for study protocol; 36.4% for study benefits). All correctly understood that the study would not confer a direct therapeutic benefit to them.ConclusionEven though research coordinators were properly trained and the informed consent was administered according to protocol, participants demonstrated poor retention of study information. While intraoperative studies that aim to advance neuroscience knowledge represent a unique opportunity to gain fundamental scientific knowledge, improved standards for the informed consent process can help facilitate their ethical implementation. (shrink)

Over the past decade, the number of clinical trials registered with the Food and Drug Administration has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board review, data monitoring, and informed consent forms. However, the protection of human (...) subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent, that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships that one can more fully define and understand the challenges of protecting subjects in research. (shrink)

Whenever the name Edmund Husserl appears in the context of nursing research, what correctly comes to mind is the phenomenological approach to qualitative methodology. Husserl is not only considered the founder of phenomenology, but his broad concept development also contributed to the demise of positivism and inspired fruitful approaches to the social sciences. In this spirit of inspiration, it must be expressed that Husserl's theory of wholes and parts, and particularly his differentiation of parts into ‘pieces’ and ‘moments’, is very (...) helpful in guiding the selection of research methods across the board in nursing science. The purpose of this paper is to highlight a frame of reference for nursing researchers to use in examining the essential nature of that which is being studied. This frame of reference is the Husserlian philosophy of ‘pieces’ and ‘moments’ in relation to the whole. ‘Pieces’ are independent parts of the whole that are subject to isolability in study, whereas ‘moments’ are nonindependent parts, which cannot be detached, presented, or studied apart from the whole. The intent is to propose this frame of reference as a philosophical base from which nursing researchers may better select among paradigms and methodological approaches in regard to the essential nature (‘pieces’ or ‘moments’) of that which they are researching. (shrink)

The philosopher Henry Richardson's short book is a defense of a position on a neglected topic in medical research ethics. Clinical research ethics has been a longstanding area of study, dating back to the aftermath of the Nazi death-camp doctors and the Tuskegee syphilis study. Most ethical regulations and institutions have developed in response to those past abuses, including the stress on obtaining informed consent from the subject. Richardson points out that that these ethical regulations do not address one of (...) the key dilemmas faced by medical researchers -- whether or not they have obligations towards subjects who need care not directly related to the purpose of the study, termed 'ancillary care obligation'. (shrink)

In both academic literature and the media, financial conflicts of interest in human subjects research have come center-stage. The cover of a recent edition of Time magazine features a research subject in a cage with the caption human guinea pigs, signifying perhaps that human research subjects are no more protected from research abuses than are laboratory animals. That magazine issue highlights three well-publicized cases of human subjects research violations that occurred at the University of Oklahoma, the University of Pennsylvania, and (...) Johns Hopkins University.At St. John Medical Center in Tulsa, Oklahoma, a study that was co-sponsored by the University of Oklahoma Health Sciences Center investigated an experimental vaccine for malignant melanoma. In that case, the chair of the university's institutional review board — the committee within each medical institution charged with ethics review of human research projects undertaken at that institution — and the dean of the University's College of Medicine allegedly concealed from both the IRB and the United States Food and Drug Administration a report by an outside consulting firm that had found severe deficiencies with the melanoma vaccine study being conducted at the medical center. (shrink)

Volume 20, Issue 2, February 2020, Page 38-41.

The capacity-building strategy used by a US-based research organisation, the Pacific Institute for Research and Evaluation , to strengthen the system for the protection of human research subjects and the infrastructure of its international collaborating partner, the University of Liberia, are discussed. To conduct the much-needed biomedical and social science-based research-related activities in the future, this partnership is expected by PIRE to gradually evolve over time to strengthen the capacity of the local investigators and administrators of the University of Liberia. (...) Accordingly, a unique opportunity to share technology and resources with a post-conflict, resource-constrained country is created by this partnership. This capacity-building model to strengthen the protection of human subjects in research can also be replicated in similar resource-constrained international settings and, accordingly, our experiences and limitations are shared in this paper. (shrink)

Denmark is a society that has already moved towards Big Data and a Learning Health Care System. Data from routine healthcare has been registered centrally for years, there is a nationwide tissue bank, and there are numerous other available registries about education, employment, housing, pollution, etcetera. This has allowed Danish researchers to study the link between exposures, genetics and diseases in a large population. This use of public registries for scientific research has been relatively uncontroversial and has been supported by (...) facilitative regulation that allows data to be used without the consent of data subjects. However, in the future much of the data will not be held by public authorities but by private companies. What are the implications of this shift for the governance of the research use of the data? This paper will argue that increased involvement of Research Ethics Committees and better training of researchers are necessary; and that some form of consent will have to be re-introduced. Four different consent models will be discussed: Opt-Out, Broad/Blanket consent, Dynamic consent, and Meta consent. It will be argued that a governance model including a possibility for citizens to make meta-choices strikes the best balance between individual and public interests. (shrink)

John. R. Searle’s account of perception is often called the intentionality theory of perception (ITP). ITP maintains direct realism. According to direct realism, physical objects are directly perceived. Searle denies Locke's representational theory of perception since the latter is an antithesis of direct realism. Searle's contention is that, first, according to the representational theory of perception, subjective ideas (mind-dependent entities) are the only object of perception, we do not perceive physical objects at all. Second, Searle says that on the face (...) of the resemblance thesis, the representational theory of perception is not secured because the former is insufficient to explain the latter. This paper is an attempt to reflect on these two charges raised by Searle. First, I will try to show how we can conceive physical objects are objects (indirect) of perception within Locke’s representational theory of perception. Then, it will be argued that Locke’s representationalist theory of perception can be upheld without the support of the resemblance thesis. (shrink)

Ravelingien et al1 argue that we should recategorise people in a permanent vegetative state as dead. Although the dilemma they describe is very real, their solution will not work. Other respondents to this paper have advanced several powerful arguments against the attempt to describe patients in a PVS as dead. Fortunately, the original argument contains sufficient resources for developing an alternative solution to this dilemma without having to radically change the current legal or social status of patients in a PVS. (...) In fact, patients in a PVS may be enrolled in xenotransplantation experiments, provided that their prior informed consent has been sought.The motivation for the original paper was to resolve an apparently intractable ethical conflict. On the one hand, there are powerful ethical and medical reasons for proceeding with research into the transplantation of non-human organs into human patients, whereas on the other, there are equally powerful ethical reasons for blocking whole-organ transplant experiments. These reasons are unusual in that special problems with xenotransplantation will block experiments that are permitted in other cases. In particular, the unquantifiable risk of a pandemic triggered by diseases such as porcine endogenous retrovirus crossing the species barrier will either block the research or expose subjects to the risk of indefinite quarantine . The authors also argue that the restrictions placed on transplant recipients and the possibility of long-term and intrusive monitoring, restrictions on sexual contacts and reproduction, and possible confinement represent excessive and ethically unjustifiable burdens. Over time, the recipients may wish to withdraw their consent, but the risks to public health would prevent them from doing so, thereby violating the basic principle that subjects of scientific and medical experiments should be able to revise or withdraw consent . …. (shrink)

This case explores the ethical landscape around recontacting a subject's relatives to return genetic research results when the informed consent form signed by the original cohort of subjects is silent on whether investigators may share new information with the research subject's family. As a result of rapid advances in genetic technology, methods to identify genetic markers can mature during the life course of a study. In this case, the investigators identified the genetic mutation responsible for the disorder after a number (...) of their original subjects had died. The researchers now have the ability to inform relatives of the subject about their risk of developing the same disease. Mark Rothstein, JD, from the University of Louisville School of Medicine, provides an overview of the medical/scientific, legal, and ethical issues underlying this case. Lauren Milner, PhD, and colleagues at Stanford University explore how the relationship between researcher and subject affect this debate. Seema Shah, JD, and colleagues at the National Institutes of Health and University of California, Los Angeles discuss whether and how requirements of the duty to warn are applicable in this case. (shrink)

Over the past decade, the number of clinical trials registered with the Food and Drug Administration has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board review, data monitoring, and informed consent forms. However, the protection of human (...) subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent, that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships that one can more fully define and understand the challenges of protecting subjects in research. (shrink)

In the 1960s, human experimentation and public funding of research increased significantly, and with the rise of the modern teaching hospital, the distinction between clinical care and experimentation became more and more blurred. Yet little in the way of meaningful government regulation existed in the United States prior to 1970. In 1966, Paul Freund, the president of the American Academy of Arts and Sciences, appointed an interdisciplinary working group to consult on the issues being raised by human experimentation. Contributions from (...) the group were published in a 1969 issue of Daedalus titled Ethical Aspects of Experimentation with Human Subjects. In the lead essay, Hans Jonas challenged then‐conventional understandings of the moral problems posed by research involving humans and argued for an alternative moral framework. To Jonas, it mattered whether the physician was trying to make the patient well rather than trying to find out how to improve the health of future patients. (shrink)

In this essay I address the question, “What is the subject matter of phenomenological research?” I argue that in spite of the increasing popularity of phenomenology, the answers to this question have been brief and cursory. As a result, contemporary phenomenologists lack a clear framework within which to articulate the aims and results of their research, and cannot easily engage each other in constructive and critical discourse. Examining the literature on phenomenology’s identity, I show how the question of phenomenology’s subject (...) matter has been systematically neglected. It has been overshadowed by an unending concern with phenomenology’s methodological identity. However, an examination of recent contributions to this literature reveals that a concern with articulating phenomenology’s subject matter has gradually increased, although such articulations remain preliminary. In light of this, I delineate, define, and illustrate three layers of phenomenological research, which I term “existentials,” “modes,” and “prejudices.” While the delineation of these layers is drawn primarily from classical phenomenological texts, they are defined and illustrated through the use of more contemporary literature. Following the articulation of this subject matter, I briefly consider some of the debates—both foundational and applied—that can be facilitated by the adoption of this framework. (shrink)

Following promulgation of the Nuremberg code in 1947, the ethics of research on human subjects has been a challenging and often contentious topic of debate. Escalation in the use of research participants in low-income countries over recent decades , has intensified the debate on the ethics of international research and led to increasing attention both to exploitation of vulnerable subjects and to considerations of how the 10:90 gap in health and medical research could be narrowed. In 2000, prompted by the (...) discussions over several years that led to the US NIH launching a capacity building programme on research ethics for members of research ethics committees in developing countries, we advanced a ‘new look’ for the ethics of international research.1 Since then progress has been made on several fronts.First, our ideas—considered somewhat radical and impractical at the time—have been provocatively addressed by scholars who have either contested them or advanced similar conceptions of what obligations international researchers have to research participants and communities in low income countries before, during and after clinical trials. Second, those researchers who have been sympathetic to our ideas have either endeavoured to put these into practice or have investigated the feasibility of doing so. Third, the intractability of the 10/90 gap and the escalation of interest in global health have sensitised many to the need to amplify the uptake of these ideas in practice.Here, we briefly review the conceptual and practical developments in international research ethics. While much conceptual progress has been made (and the concepts are now appearing …. (shrink)

Research involving recently deceased humans that are physiologically maintained following declaration of death by neurologic criteria—or ‘research involving the recently deceased’—can fill a translational research gap while reducing harm to animals and living human subjects. It also creates new challenges for honouring the donor’s legacy, respecting the rights of donor loved ones, resource allocation and public health. As this research model gains traction, new empirical ethics questions must be answered to preserve public trust in all forms of tissue donation and (...) in the practice of medicine while respecting the legacy of the deceased and the rights of donor loved ones. This article suggests several topics for immediate investigation to understand the attitudes and experiences of researchers, clinical collaborators, donor loved ones and the public to ensure research involving the recently deceased advances ethically. (shrink)

Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. (...) Nanotherapeutics andin vivonanodiagnostics incorporate materials that are engineered at the nanoscale to express novel properties that are medicinally useful. These nanomedicine applications can also contain nanomaterials that are biologically active, producing interactions that depend on biological triggers. Examples include nanoscale formulations of insoluble drugs to improve bioavailability and pharmacokinetics, drugs encapsulated in hollow nanoparticles with the ability to target and cross cellular and tissue membranes and to release their payload at a specific time or location, imaging agents that demonstrate novel optical properties to aid in locating micrometastases, and antimicrobial and drug-eluting components or coatings of implantable medical devices such as stents. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Examining the Ethics of Human Subjects ResearchPaul S. Appelbaum (bio)The work of the Advisory Committee on Human Radiation Experiments confirms once again the value of combining empirical and normative approaches to problems in clinical and research ethics. The Committee, like its predecessor, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, spent relatively modest sums of money gathering targeted data to inform (...) its deliberations. The results of the Committee’s research, which are discussed by Nancy Kass and Jeremy Sugarman in this issue of the Kennedy Institute of Ethics Journal, enhance our understanding of the current ethical status of human subjects research, helping to focus attention on areas of particular concern, and lay the basis for future research and policy development.My comments here focus on the two major empirical studies conducted by the Committee—the Research Proposal Review Project and the Subject Interview Study. I will underscore just a few of the primary findings from these studies, consider their limitations, and explore their implications. Readers interested in the details of the studies should consult the Committee’s Final Report (ACHRE 1995), on which I rely in part and which provides additional information on the methodology and findings of the studies.Research Proposal Review ProjectWhat can be learned from the Committee’s review of 125 federally-funded human research studies? In answering that question, one cannot ignore the irony inherent in the Committee’s decision to review documents related to institutional review board (IRB) consideration of the selected protocols. The single most frequent complaint about the current system for protecting human subjects is that IRBs focus almost exclusively on review of consent forms and other research documents, as if they bore some close relationship to what actually transpires between investigators and potential research subjects. Only a small number of studies examine the research consent process. Nevertheless, existing data strongly [End Page 283] suggest that subject recruitment often involves an extended process of courtship, during which the information contained in consent forms is only a small part of the information passed between investigators and subjects (Benson, Roth, and Winslade 1985; Lidz et al. 1984).Indeed, the second of the Committee’s studies—the Subject Interview Study, which is discussed below—appears to confirm these findings. In-depth interviews with 99 individuals who reported that they were former or current research subjects suggest that “[f]or many, the decision to participate seemed to have been made before the consent form was given to them, and they signed it almost as a formality” (ACHRE 1995 [GPO, p. 742; Oxford, p. 471]). 1 Why, then, did the Committee focus its attention on documents that in many cases seem to play only a tangential role in the consent process? As is the case with IRBs around the country, the answer appears to be that consent forms and related documents are the only easily available window on consent transactions. In addition, under the current system, consent forms constitute the part of the process that IRBs can influence most easily. Consequently, it suits almost everyone’s needs—except perhaps those of the research subjects—to pretend that they reflect what actually transpires in the recruitment process. To the Committee’s credit, it was well aware of this dilemma. Nonetheless, it struggled to wring valid lessons from these limited data in its Final Report.Perhaps the most interesting finding from the Research Proposal Review Project is just how poor so many consent forms are. Given the disproportionate emphasis that many IRBs place on the content of the forms, one would expect that investigators by now would have learned to design documents that meet objective standards of adequacy, such as those applied by the Committee. Indeed, except in the most unusual circumstances, doing so would virtually guarantee that the IRB will ask no further questions about subject recruitment procedures. Although the data justify the inference that many investigators do not yet understand which information is essential to communicate to potential subjects, nor have learned how to do so effectively, they also force us to a still more radical conclusion. If the IRBs were doing their jobs, the Committee... (shrink)

In both academic literature and the media, financial conflicts of interest in human subjects research have come center-stage. The cover of a recent edition of Time magazine features a research subject in a cage with the caption human guinea pigs, signifying perhaps that human research subjects are no more protected from research abuses than are laboratory animals. That magazine issue highlights three well-publicized cases of human subjects research violations that occurred at the University of Oklahoma, the University of Pennsylvania, and (...) Johns Hopkins University.At St. John Medical Center in Tulsa, Oklahoma, a study that was co-sponsored by the University of Oklahoma Health Sciences Center investigated an experimental vaccine for malignant melanoma. In that case, the chair of the university's institutional review board — the committee within each medical institution charged with ethics review of human research projects undertaken at that institution — and the dean of the University's College of Medicine allegedly concealed from both the IRB and the United States Food and Drug Administration a report by an outside consulting firm that had found severe deficiencies with the melanoma vaccine study being conducted at the medical center. (shrink)

During a pandemic, where there is widespread human infection, various and varying measures are taken that are targeted at public health objectives. During the early stages of a pandemic, these objectives may focus on containing the disease and minimizing its spread, but they may switch to mitigation as the emergent infectious disease takes hold in a population. There has been considerable debate and elucidation of the ethical principles and framework for the various responses including the need to fast track research (...) and vaccine development. However, the measures imposed during a pandemic would have unintended and untoward effect on ongoing clinical research. For example, precautionary measures, such as social distancing, may hamper ongoing clinical research, because recruitment and participation of patients and healthy volunteers is a potential source of virus spread. In this paper, we argue that a framework is needed to ensure the continuity of such research. Such a framework that considers the pertinent issues would need the ‘buy in’ of the key stakeholders (policy makers, funding agencies, institutional authorities, researchers and subjects) to ensure that the issues that are ethically relevant to pandemic planning would not be neglected or overlooked. (shrink)

Psychiatry is rapidly adopting digital phenotyping and artificial intelligence/machine learning tools to study mental illness based on tracking participants’ locations, online activity, phone and text message usage, heart rate, sleep, physical activity, and more. Existing ethical frameworks for return of individual research results (IRRs) are inadequate to guide researchers for when, if, and how to return this unprecedented number of potentially sensitive results about each participant’s real-world behavior. To address this gap, we convened an interdisciplinary expert working group, supported by (...) a National Institute of Mental Health grant. Building on established guidelines and the emerging norm of returning results in participant-centered research, we present a novel framework specific to the ethical, legal, and social implications of returning IRRs in digital phenotyping research. Our framework offers researchers, clinicians, and Institutional Review Boards (IRBs) urgently needed guidance, and the principles developed here in the context of psychiatry will be readily adaptable to other therapeutic areas. (shrink)

This paper argues that the reading of Althusser which finds a pronounced continuity in his conception of the relations among science, philosophy, and politics is the correct one, this essay will begin with an examination of Althusser’s “scientism.” The meaning of this term (one that differs slightly from contemporary usages) will be specified before showing how and in what way Althusser’s political philosophy between 1960 and 1980 can be described as “scientistic.” The next section details the important political role Althusser (...) assigned to the sciences and particularly to the science of historical materialism during this period. This accomplished, the arguments of interpreters who emphasize the apparent difference in Althusser’s attitude towards science before and after 1980 will be considered. Here, possible reasons for such a reading will be rehearsed. Next, with the support of recently published and archival documents, this essay will engage in a close and comparative reading of Althusser’s texts from the 1970s and 1980s that have as their subject the relations among philosophy, science, and politics. This survey will show the continuity in Althusser’s position vis-à-vis the sciences: namely, that if we want good (i.e. desired) socio-politico-economic changes to result from our political actions, then it is necessary to engage in social scientific research or, at the very least, to consult such research and to use this knowledge in our political decision making. All this serves to support the conclusion that Althusser’s “new” political philosophy from the 1980s is not really so new. On the contrary, his writings on the materialism of the encounter and aleatory materialism represent prolongations and elaborations of positions and ideas already developed in the 1960s and 1970s and that include a mostly consistent understanding of the relations between scientific knowledge and political action. This is true even if the rhetorical and philosophical style in which these ideas are put forth in the 1980s differs from the ways in which these ideas were introduced during the prior two decades. (shrink)

This article reflects on pivotal concepts of psychoanalytic practice and theory, applied to a single case study to create new meanings. Drawing from the concepts of transference, countertransference, and projective identification, the author presents the notion that the researcher's subjective reactions are created and induced by the subject of study precisely because this is one, and sometimes the only way available to the subject to communicate something that is out of its full awareness. In essence, some unconscious material can be (...) expressed nonverbally by the subject by means of provoking visceral and bodily reactions in the researcher, or in some cases, psychic imagery such as dreams or fantasies. The material can be meaningfully interpreted by the researcher by receiving, containing, and sorting through these inchoate emotional reactions within self. (shrink)

The COVID-19-pandemic brought massive changes in the provision of psychotherapy. To contain the pandemic, many therapists switched from face-to-face sessions in personal contact to remote settings. This study focused on psychodynamic therapists practicing Guided Affective Imagery, Hypnosis and Autogenous Relaxation and their subjective experiences with psychotherapy via telephone and videoconferencing during the first COVID-19 related lockdown period in March 2020 in Austria. An online survey completed by 161 therapists produced both quantitative and qualitative data with the latter being subject to (...) a qualitative content analysis. Our research suggests that telephone and videoconferencing are considered valuable treatment formats to deliver psychodynamic psychotherapy. However, therapists’ experiences with remote psychotherapy are multifaceted and ambiguous. In particular, the findings raise questions concerning the maintenance of the therapeutic alliance, the development of the analytic process, the sensitivity to unconscious communication, and the indication for certain types of patients that still need further investigation. Our research indicates that the long-standing reticence toward remote treatments offers among psychodynamic therapists is becoming more differentiated and partially dissolves as therapists gain experiences in their use. Attitudes are becoming more open. At the same time, the way is being prepared to take a closer look at the specific processes and dynamics of remote psychotherapy and to examine them critically in future studies. (shrink)