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

Clinical trials aim to minimise participant risk and generate new clinical knowledge for the wider population. Many military agencies are now investing efforts in pushing towards developing new treatments involving Brain-Computer Interfaces, Gene Therapy and Stem Cells interventions. These trials are targeting smaller disease groups, as such they give rise to novel participant risks of harms that are largely not accommodated by existing practice. This is of most concern with irreversible harms at early trial stages, where participants may forfeit any (...) future therapy, and in personalised medicine, where the individual participant assumes all of the trial risk. Given these new experimental interventions involve high risk of irreversible harms, how much risk should patients be exposed to when participating in experimental testing of innovative technologies? Designing clinical trials which better balance risk/benefit ratios for participants is crucial. The aim of this book chapter is to suggest a new stratified risk framework aimed at minimising the risk-benefit ratio to participants in clinical trials associated with high risk of irrevocable harms. We will argue it demands a higher-level of clinical data capture at earlier trial stages than predicated by current trial doctrine; it also requires publication of all trial data to minimise risk to participants of any future trial. (shrink)

Background In the wake of mandates for biomedical research to increase participation by members of historically underrepresented populations, community engagement (CE) has emerged as a key intervention to help achieve this goal.Methods Using interviews, observations, and document analysis, we examine how stakeholders in precision medicine research understand and seek to put into practice ideas about who to engage, how engagement should be conducted, and what engagement is for.Results We find that ad hoc, opportunistic, and instrumental approaches to (...) CE exacted significant consequences for the time and resources devoted to engagement and the ultimate impacts it has on research. Critical differences emerged when engagement and research decisionmaking were integrated with each other versus occurring in parallel, separate parts of the study organization, and whether community members had the ability to determine which issues would be brought to them for consideration or to revise or even veto proposals made upstream based on criteria that mattered to them. CE was understood to have a range of purposes, from instrumentally facilitating recruitment and data collection, to advancing community priorities and concerns, to furthering long-term investments in relationships with and changes in communities. These choices about who to engage, what engagement activities to support, how to solicit and integrate community input into the workflow of the study, and what CE was for were often conditioned upon preexisting perceptions and upstream decisions about study goals, competing priorities, and resource availability.Conclusions Upstream choices about CE and constraints of time and resources cascade into tradeoffs that often culminated in “pantomime community engagement.” This approach can create downstream costs when engagement is experienced as improvised and sporadic. Transformations are needed for CE to be seen as a necessary scientific investment and part of the scientific process. (shrink)

From an ethical standpoint, the goal of clinical research is to benefit patients. While individual investigations may not yield results that directly improve patients’ evaluation or treatment, the corpus of the research should lead in that direction. Without the goal of ultimate benefit to patients, such research fails as a moral enterprise. While this may seem obvious, the need to protect and benefit patients can get lost in the milieu of clinical research. Many advances in emergency (...) medicine have been based upon the results of research studies conducted both within the specialty and by others outside of the field. But has this research benefited patients? Has it followed the Hippocratic commitment “to do good or at least do no harm”? The answer is: yes, and no. This paper attempts to demonstrate this: first by citing advances from applied research that have benefited emergency department patients over the past three decades, and follows with some aspects of emergency medicine research that makes one question both its safety and its efficacy. While enormous gains have been made in patient care as a result of emergency medical research, ethical considerations complicate this rosy picture, and point to future areas of concern for researchers. (shrink)

With the growth of precision medicine research on health data and biospecimens, research institutions will need to build and maintain long-term, trusting relationships with patient-participants. While trust is important for all research relationships, the longitudinal nature of precision medicine research raises particular challenges for facilitating trust when the specifics of future studies are unknown. Based on focus groups with racially and ethnically diverse patients, we describe several factors that influence patient trust and potential institutional (...) approaches to building trustworthiness. Drawing on these findings, we suggest several considerations for research institutions seeking to cultivate long-term, trusting relationships with patients: Address the role of history and experience on trust, engage concerns about potential group harm, address cultural values and communication barriers, and integrate patient values and expectations into oversight and governance structures. (shrink)

Precision medicine research is rapidly taking a lead role in the pursuit of new ways to improve health and prevent disease, but also presents new challenges for protecting human subjects. The extent to which the current “web” of legal protections, including technical data security measures, as well as measures to restrict access or prevent misuse of research data, will protect participants in this context remains largely unknown. Understanding the strength, usefulness, and limitations of this constellation of laws, (...) regulations, and procedures is critical to ensuring not only that participants are protected, but also that their participation decisions are accurately informed. To address these gaps, we conducted in-depth interviews with a diverse group of 60 thought-leaders to explore their perspectives on the protections associated with precision medicine research. (shrink)

Lee emphasizes the need to better understand the moral relationship between researchers and participants connoted by precision medicine, with the framework of “the gift” offering bioethics a...

Purpose: This review identifies the prominent topics in the literature pertaining to the ethical, legal, and social issues raised by research investigating personalized genomic medicine. Methods: The abstracts of 953 articles extracted from scholarly databases and published during a 5-year period were reviewed. A total of 299 articles met our research criteria and were organized thematically to assess the representation of ELSI issues for stakeholders, health specialties, journals, and empirical studies. Results: ELSI analyses were published in both (...) scientific and ethics journals. Investigational research comprised 45% of the literature reviewed and the remaining 55% comprised normative analyses. Traditional ELSI concerns dominated the discourse including discussions about disclosure of research results. In fact, there was a dramatic increase in the number of articles focused on the disclosure of research results and incidental findings to research participants. Few papers focused on particular disorders, the use of racial categories in research, international communities, or special populations. Conclusion: Considering that strategies in personalized medicine increasingly target individuals’ unique health conditions, environments, and ancestries, further analysis is needed on how ELSI scholarship can better serve the increasingly global, interdisciplinary, and diverse PGM research community. (shrink)

This article considers various approaches used in complementary and alternative medicine research, and discusses the challenges that reviewing such research poses for Human Research Ethics Committees. Drawing on our experience with the University of Technology Sydney HREC, we offer some suggestions about how ethical principles governing conventional medical research can be applied in the context of research in complementary and alternative medicine. We argue that effective HREC review requires members to gain familiarity with (...) such research, which helps ensure that such research is conducted rigorously and ethically. (shrink)

Background Over the last decade, the return of results (ROR) in precision medicine research (PMR) has become increasingly routine. Calls for individual rights to research results have extended the “duty to report” from clinically useful genetic information to traits and ancestry results. ROR has thus been reframed as inherently beneficial to research participants, without a needed focus on who benefits and how. This paper addresses this gap, particularly in the context of PMR aimed at increasing participant (...) diversity, by providing investigator and researcher perspectives on and questions about the assumed value of ROR in PMR.Methods Semi-structured interviews with a purposive sample of investigators and researchers across federally funded PMR studies in three national consortia, as well as observations of study activities, focused on how PM researchers conceptualize diversity and implement inclusive practices across research stages, including navigating ROR.Results Interviewees (1) validated the value of ROR as a benefit of PMR, while others (2) questioned the benefit of clinically actionable results to individuals in the absence of sufficient resources for translating findings into health care for diverse and disadvantaged populations; (3) expressed uncertainties in applying the presumed value of ROR as a benefit for non-clinical results; and (4) and debated when the promise of the value of ROR may undermine trust in PMR, and divert efforts to return value beyond ROR.Conclusions Conceptualizations of diversity and inclusion among PM researchers and investigators raise unique ethical questions where unexamined assumptions of the value of ROR inform study recruitment efforts to enroll minoritized and under-represented populations. A lack of consideration for resources and infrastructure necessary to translate ROR into actionable information may hinder trustworthy community-research relationships. Thus, we argue for a more intentional interrogation of ROR practices as an offer of benefit and for whom. (shrink)

In their target article, Galasso (2024) highlights the limitations of upstream inclusion in precision medicine research to produce downstream benefits to participants and proposes precision public...

Galasso (2024) provides a strong critique of precision medicine research initiatives regarding their potential for the exclusion of populations based on upstream and downstream factors with “Genomi...

Galasso (2024) shares findings from narrative analyses of relevant constituting material of and interviews with leaders in two national precision medicine research (PMR) programs: 100KGP of Genomic...

This paper attempts to provide a broader view into the ethical issues surrounding the field of emergency medicine (EM) research. It starts from defining bioethically relevant features of EM and presents this field in the context of different models of health care provider–patient relationship. The paper also provides a short overview of the “post-Nuremberg” evolution of the main international research ethics guidelines relevant to EM research which demonstrates a tendency of liberalization of research on incapable (...) persons. This tendency culminates with the exceptions to informed consent for EM research which is supposed to be balanced by other research ethics principles, especially a careful rationing of risks and benefits. This finally brings us towards a critical analysis of the minimal risk standard which is one of the main fundamental safeguards in EM research. (shrink)

From its inception, genomics has been a speculative endeavor, fixated on a far-off horizon that would deliver on the promise of targeted diagnostics and individualized therapeutics (Fortun 2008). M...

Dr. Galasso’s (2024) insightful article expands the ongoing debate on the utility and equity of precision medicine in public and population health. The initiatives mentioned, Genomics England and t...

To accelerate the adoption of a new method with a high potential to replace or extend an existing, presumably less accurate, medical scoring system, evaluation should begin days after the new concept is presented publicly, not years or even decades later. Metaphorically speaking, as chameleons capable of quickly changing colors to help their bodies adjust to changes in temperature or light, health-care decision makers should be capable of more quickly evaluating new data-driven insights and tools and should integrate the highest (...) performing ones into national and international care systems. Doing so is essential, because it will truly save the lives of many individuals. (shrink)

As opposed to a ‘one size fits all’ approach, precision medicine uses relevant biological, medical, behavioural and environmental information about a person to further personalize their healthcare. This could mean better prediction of someone’s disease risk and more effective diagnosis and treatment if they have a condition. Big data allows for far more precision and tailoring than was ever before possible by linking together diverse datasets to reveal hitherto-unknown correlations and causal pathways. But it also raises ethical issues relating (...) to the balancing of interests, viability of anonymization, familial and group implications, as well as genetic discrimination. This article analyses these issues in light of the values of public benefit, justice, harm minimization, transparency, engagement and reflexivity and applies the deliberative balancing approach found in theEthical Framework for Big Data in Health and Research to a case study on clinical genomic data sharing. Please refer to that article for an explanation of how this framework is to be used, including a full explanation of the key values involved and the balancing approach used in the case study at the end. Our discussion is meant to be of use to those involved in the practice as well as governance and oversight of precision medicine to address ethical concerns that arise in a coherent and systematic manner. (shrink)

Increasing philosophical attention is being directed to the rapidly growing discipline of evidence-based medicine. Philosophical discussions of EBM, however, remain narrowly focused on randomization, mechanisms, and the sociology of EBM. Other aspects of EBM have been all but ignored, including the nature of clinical reasoning and the question of whether it can be standardized; the application of EBM principles to the logic, value, and ethics of diagnosis and prognosis; evidence synthesis ; and the nature and ethics of placebo controls. (...) Philosophical analysis in each of these areas has the potential to enhance the discussion of EBM methodology and practice. (shrink)

Tōjisha research is a methodology intended to help psychiatric patients through dialogue. It was introduced in the context of community care in Bethel House (Hokkaido, Japan) in the early 2000s and later spread to other parts of Japan as well as abroad because of its originality and apparent therapeutic success. It offers patients a framework to investigate their own problems, symptoms, and delusions and to build a discourse around them. In this paper, I present a short account of tōjisha (...) research and I put it in the context of current debates over the benefits and drawbacks of narrative medicine. I argue that there is an original conception of the self and of empowerment of patients in tōjisha research compared to other models of narrative medicine. Finally, I mobilize these original aspects to address some rebuttals of narrative medicine. (shrink)

In this article, I argue that distinguishing ‘evolutionary’ from ‘Darwinian’ medicine will help us assess the variety of roles that evolutionary explanations can play in a number of medical contexts. Because the boundaries of evolutionary and Darwinian medicine overlap to some extent, however, they are best described as distinct ‘research traditions’ rather than as competing paradigms. But while evolu- tionary medicine does not stand out as a new scientific field of its own, Darwinian medicine is (...) united by a number of distinctive theoretical and methodological claims. For example, evolutionary medicine and Darwinian medicine can be distinguished with respect to the styles of evolutionary explanations they employ. While the former primarily involves ‘forward looking’ explanations, the latter depends mostly on ‘backward looking’ explanations. A forward looking explanation tries to predict the effects of ongoing evolutionary processes on human health and disease in contem- porary environments (e.g., hospitals). In contrast, a backward looking explanation typically applies evolutionary principles from the vantage point of humans’ distant biological past in order to assess present states of health and disease. Both approaches, however, are concerned with the prevention and control of human diseases. In con- clusion, I raise some concerns about the claim that ‘nothing in medicine makes sense except in the light of evolution’. (shrink)

Society is failing in its moral obligation to improve the standard of healthcare provided to vulnerable populations, such as people who lack decision making capacity, by a misguided paternalism that seeks to protect them by excluding them from medical research. Uncertainties surround the basis on which decisions about research participation is made under dual regulatory regimes, which adds further complexity. Vulnerable individuals’ exclusion from research as a result of such regulation risks condemning such populations to poor quality (...) care as a result of ‘evidence biased’ medicine. This paper explores the research regulation provisions for proxy decision making for those unable to provide informed consent for themselves, and the subsequent legal and practical difficulties for decision-makers. There are two separate regulatory regimes governing research involving adults who lack capacity to consent in England and Wales. The Mental Capacity Act 2005 governs how incapacitated adults can be involved in research, however clinical trials of medicinal products are separately regulated by the Medicines for Human Use Regulations 2004. There are significant differences under these dual regimes in the provisions for those lacking capacity to participate in medical research. The level of risk permitted differs, with a greater requirement for justification for participation in a clinical trial than other types of research. Who acts as proxy decision maker, how much information is provided to the person lacking capacity, and whether they retain the power of veto also significantly differs. The development of two separate regulatory regimes has resulted in significant differences between the provisions for clinical trials and other forms of research, and from usual medical practice. The resulting uncertainty has reinforced the tendency of those approving and conducting research to exclude adults lacking capacity to avoid difficult decisions about seeking consent for their participation. Future developments, such as the incoming EU Regulations, may address some of these differences, however the justification and level of risk permitted requires review to ensure that requirements are appropriate and proportionate to the burdens and risks for the individual, and also to the benefits for the wider population represented. (shrink)

This timely Research Handbook offers significant insights into an understudied subject, bringing together a broad range of socio-legal studies of medicine to help answer complex and interdisciplinary questions about global health - a major challenge of our time. Interdisciplinary chapters explore both how the terrain of medicine can generate new questions about law, regulation and the state, and how the law intersects with health and medicine at every level. Bringing together leading international scholars, the Research (...) Handbook assembles concrete case studies to suggest avenues for further research on socio-legal inquiries, such as the construction of disorders by law, the reparation of injuries, and how race and gender impact justice. The Research Handbook for Socio-Legal Studies of Medicine and Health will be an inspiring read for researchers, academics and graduate students in the fields of health law, socio-legal studies, and gender and sexuality. (shrink)

Evidence-based medicine frequently uses statistical hypothesis testing. In this paradigm, data can only disconfirm a research hypothesis’ competitors: One tests the negation of a statistical hypothesis that is supposed to correspond to the research hypothesis. In practice, these hypotheses are often misaligned. For instance, directional research hypotheses are often paired with non-directional statistical hypotheses. Prima facie, one cannot gain proper evidence for one’s research hypothesis employing a misaligned statistical hypothesis. This paper sheds lights on the (...) nature of and the reasons for such misalignments and it provides a thorough analysis of whether they pose a threat to evidence-based medicine. The upshots are that the misalignments are often hidden for clinicians and that although some cases of misalignments can be partially counterbalanced, the overall threat is non-negligible. The counterbalances either lead to methodological inadequacy, loss of statistical power, or involve a lack of information that could be crucial for decision making. This result casts doubt on various findings of medical studies in addition to issues associated with under-powered studies or the replication crisis. (shrink)

Philosophy of medicine encompasses a broad range of methodological approaches and theoretical perspectives—from the uses of statistical reasoning and probability theory in epidemiology and evidence-based medicine to questions about how to recognize the uniqueness of individual patients in medical humanities, person-centered care, and values-based practice; and from debates about causal ontology to questions of how to cultivate epistemic and moral virtue in practice. Apart from being different ways of thinking about medical practices, do these different philosophical approaches have (...) anything in common? Are they committed to incompatible assumptions about the nature of science and its relationship to experience, value, and the art of medicine, or are different approaches nonetheless complementary? The chapter examines the questions these different approaches and perspectives raise and considers why so many theorists of medicine seek to find a “base” or “center” for medicine—as though there is, or should be, some general conceptual thread linking the things we call “usual clinical practice” in the real world. It further considers whether there are alternative approaches to the philosophy of medicine, which do not embody this philosophical assumption; and it suggests that a key tool for evaluating approaches must be their ability to contribute something of genuine value to clinical medicine. (shrink)

The authors suggest creating a scheme that offers new incentives for research on diseases disproportionately affecting the poor, with the goal of making development of neglected disease vaccines a lucrative endeavor for pharmaceutical companies.

One of the most important developments in international medicine over the past two decades has been a turn to the market as a way of coping with rising costs and responding to calls for more freedom from government control. A full moral evaluation of the relationship of medicine and the market requires asking a wide range of questions bearing on the meaning and impact of market strategies on the economics of health care and on the clinical and public (...) health outcomes of those strategies. A number of the leading questions are presented and some provisional answers offered. (shrink)

Assisted reproduction , particularly that performed using donated gametes, increases the prospect of healthy babies being delivered to increasing numbers of people striving for parenthood. The psychosocial, ethical and legislative issues related both to the donation and receipt of gametes are perceived as extraordinarily complicated. In 2009, a research project aimed at mapping the issues was drawn up and implemented in the Czech Republic. The project should have provided material for consultation purposes, for the work of ethical and legislative (...) bodies, and for better interdisciplinary and international communication in reproductive medicine. Work on the project was affected by several unforeseen events, particularly by the drafting and adoption of a new law on ART . The article describes the dynamic and structural changes occurring within the project due to drafting of the bill as well as the changes and consequences resulting from other circumstances related to the topic researched. (shrink)

Philosophy of medicine encompasses a broad range of methodological approaches and theoretical perspectives—from the uses of statistical reasoning and probability theory in epidemiology and evidence-based medicine to questions about how to recognize the uniqueness of individual patients in medical humanities, person-centered care, and values-based practice; and from debates about causal ontology to questions of how to cultivate epistemic and moral virtue in practice. Apart from being different ways of thinking about medical practices, do these different philosophical approaches have (...) anything in common? Are they committed to incompatible assumptions about the nature of science and its relationship to experience, value, and the art of medicine, or are different approaches nonetheless complementary? The chapter examines the questions these different approaches and perspectives raise and considers why so many theorists of medicine seek to find a “base” or “center” for medicine—as though there is, or should be, some general conceptual thread linking the things we call “usual clinical practice” in the real world. It further considers whether there are alternative approaches to the philosophy of medicine, which do not embody this philosophical assumption; and it suggests that a key tool for evaluating approaches must be their ability to contribute something of genuine value to clinical medicine. (shrink)

_Philosophy of Molecular Medicine: Foundational Issues in Theory and Practice_ aims at a systematic investigation of a number of foundational issues in the field of molecular medicine. The volume is organized around four broad modules focusing, respectively, on the following key aspects: What are the nature, scope, and limits of molecular medicine? How does it provide explanations? How does it represent and model phenomena of interest? How does it infer new knowledge from data and experiments? The essays (...) collected here, authored by prominent scientists and philosophers of science, focus on a handful of mainstream topics in the philosophical literature, such as _causation_, _explanation_, _modeling_, and _scientific inference_. These previously unpublished contributions shed new light on these traditional topics by integrating them with problems, methods, and results from three prominent areas of contemporary biomedical science: _basic research_, _translational_ and _clinical research_, and _clinical practice_. (shrink)

Since its inception as an international requirement to protect patients and healthy volunteers taking part in medical research, informed consent has become the primary consideration in research ethics. Despite the ubiquity of consent, however, scholars have begun to question its adequacy for contemporary biomedical research. This book explores this issue, reviewing the application of consent to genetic research, clinical trials, and research involving vulnerable populations. For example, in genetic research, information obtained from an autonomous (...) research participant may have significant bearing on the interests of family members who have not consented to the study. This casts doubt on the adequacy of consent for such studies. This book also questions the assumptions that informed consent is essential and that it satisfactorily protects the principle of individual autonomy. It reviews recent empirical studies that challenge the possibility of truly informed consent and highlights the extent to which consent is governed by social norms and expectations. It also investigates how consent might be of secondary importance in some circumstances, for example when a research project appears to protect a public or community interest. (shrink)

Mit Beitragen von: Wolfgang U. Eckart, Christian Bonah, Wolfgang U. Eckart / Andreas Reuland, Alexander Neumann, Peter Steinkamp, Volker Roelcke, Anne ...

Innovative practice occurs when a clinician provides something new, untested, or nonstandard to a patient in the course of clinical care, rather than as part of a research study. Commentators have noted that patients engaged in innovative practice are at significant risk of suffering harm, exploitation, or autonomy violations. By creating a pathway for harmful or nonbeneficial interventions to spread within medical practice without being subjected to rigorous scientific evaluation, innovative practice poses similar risks to the wider community of (...) patients and society as a whole. Given these concerns, how should we control and oversee innovative practice, and in particular, how should we coordinate innovative practice and clinical research? In this article, I argue that an ethical approach to overseeing innovative practice must encourage the early transition to rigorous clinical research without delaying or deferring the development of beneficial innovations or violating the autonomy rights of clinicians and their patients. (shrink)

In this paper, the author argues that the requirement to conduct randomised clinical trials to inform policy in cases where one wants to identify a cheaper alternative to known effective but expensive interventions raises an important ethical issue. This situation will eventually arise whenever there are resource constraints, and a policy decision has been made not to fund an intervention on cost effectiveness grounds. It has been thought that this is an issue only in extremely resource poor settings. This paper (...) gives an example from the United Kingdom illustrating that this is also a problem faced by richer countries. (shrink)

Arguments in favor of greater research-practice integration in medicine have tended to be ethical, political, or pragmatic. There are good epistemic reasons to pursue greater integration, and it is important to think through these reasons in order to avoid inadvertently designing new systems in ways that replicate the epistemic elitism common within current systems. Meaningful transformation within health care is possible with close attention to all reasons in favor of greater research-practice integration, including epistemic reasons.