Recent work on incidental fndings, concentrating on the difcult problems posed by the ambiguous results often generated by high-tech medicine, has proceeded largely independently from recent work on medical researchers' ancillary-care obligations, the obligations that researchers have to deal with diseases or conditions besides the one(s) under study. This paper contends that the two topics are morally linked, and specifcally that a sound understanding of ancillary-care obligations will center them on incidental fndings. The paper sets out and defends an understanding (...) of ancillary-care obligations, which is based on the idea that when participants signed up for a study they may — independently of their beliefs and expectations and of those of the researchers — be taken to have partially entrusted certain aspects of their health into the researchers' hands. This partial-entrustment model of ancillary-care obligations, in turn, has substantive implications for how to deal ethically with incidental fndings; for instance, it suggests that researchers have no moral obligation to hunt for incidental fndings. (shrink)

This paper explores the convergence of two recent and growing streams of bioethical work and concern. Each has originated independently, but each arises from the fact that the Common Rule that has shaped medical research ethics, as institutionalized in the United States and also abroad, is largely silent about what needs to be done in response to researchers’ positive obligations. One stream concerns what to do about the sometimes vast range of findings that may arise incidentally to performing research procedures. (...) The other asks whether medical researchers owe their study participants any “ancillary care” — that is, medical care that their study participants need but that goes beyond what is required to do the science safely. (shrink)

Previous edition, 1st, published in 1971.

Clinicians and administrators have a professional obligation to contribute to improvement of healthcare quality. At the same time, participation in embedded research poses risks to healthcare institutions. Disclosure of an institution’s sensitive information could endanger relationships with patients and undermine its reputation. The existing ethical framework for learning healthcare systems does not address the conflict between the OTC and institutional interests. Ethical guidance and policy regulation are needed to create a safe environment for embedded research. In this article we analyse (...) the EF for LHSs and the concept of professionalism. We suggest that the EF should be supplemented with an obligation to protect provider’s legitimate interests. We define legitimate interests as those that enable providers to discharge their primary duties. We argue that both the OTC and the obligation to protect legitimate interests are grounded in the concept of medical professionalism and can be understood as a matter of contract between a democratic society and medical professionals. The proposed supplemented EF can be implemented into a regulatory system in three different ways: the self-regulating: where providers decide themselves how to balance the ethical claims, the centralised: where a governmental institution decides the right balance between providers’ interests and interests of a health system; and the mediating: where medical professionals, the state and patients negotiate their interests. Our article contributes to the discussion on ethical relevance of providers’ interests and the regulatory model for weighing opposite interests in LHSs. (shrink)

Classic statements of research ethics advise against permitting physician-investigators to obtain consent for research participation from patients with whom they have preexisting treatment relationships. Reluctance about “dual-role” consent reflects the view that distinct normative commitments govern physician–patient and investigator–participant relationships, and that blurring the research–care boundary could lead to ethical transgressions. However, several features of contemporary research demand reconsideration of the ethics of dual-role consent. Here, we examine three arguments advanced against dual-role consent: that it creates role conflict for the (...) physician-investigator; that it can compromise the voluntariness of the patient-participant’s consent; and that it promotes therapeutic misconceptions. Although these concerns have merit in some circumstances, they are not dispositive in all cases. Rather, their force—and the ethical acceptability of dual-role consent—varies with features of the particular study. As research participation more closely approximates usual care, it becomes increasingly acceptable, or even preferable, for physicians to seek consent for research from their own patients. It is time for a more nuanced approach to dual-role consent. (shrink)

Research that is integrated into ongoing clinical activities holds the potential to accelerate the generation of knowledge to improve the health of individuals and populations. Yet integrating research into clinical care presents difficult ethical and regulatory challenges, including how or whether to obtain informed consent. Multiple empirical studies have explored patients' and the public's attitudes toward approaches to consent for pragmatic research. Questions remain, however, about how to use the resulting empirical data in resolving normative and policy debates and what (...) kind of data warrants the most consideration. We recommend prioritizing data about what people consider acceptable with respect to consent for pragmatic research and data about people's informed, rather than initial, preferences on this subject. In addition, we advise caution regarding the weight given to majority viewpoints and identify circumstances when empirical data can be overridden. We argue that empirical data bolster normative arguments that alterations of consent should be the default in pragmatic research; waivers are appropriate only when the pragmatic research would otherwise be impracticable and has sufficiently high social value. (shrink)

Pragmatic clinical trials offer important benefits, such as generating evidence that is suited to inform real-world health care decisions and increasing research efficiency. However, PCTs also present ethical challenges. One such challenge involves the management of information that emerges in a PCT that is unrelated to the primary research question, yet may have implications for the individual patients, clinicians, or health care systems from whom or within which research data were collected. We term these findings as?pragmatic clinical trial collateral findings,? (...) or?PCT-CFs?. In this article, we explore the ethical considerations associated with the identification, assessment, and management of PCT-CFs, and how these considerations may vary based upon the attributes of a specific PCT. Our purpose is to map the terrain of PCT-CFs to serve as a foundation for future scholarship as well as policy-making and to facilitate careful deliberation about actual cases as they occur in practice. (shrink)

Medical ethics assumes a clear boundary between clinical research and clinical medicine: one produces knowledge for the benefit of future patients, while the other provides optimal care to individuals right now. It also assumes that the two cannot be integrated without sacrificing the needs of the current patient to those of future patients. But integration could allow us to provide better care to everyone, now and in the future.

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

Biomedical research is so important that there is a positive moral obligation to pursue it and to participate in itScience is under attack. In Europe, America, and Australasia in particular, scientists are objects of suspicion and are on the defensive.i“Frankenstein science”5–8 is a phrase never far from the lips of those who take exception to some aspect of science or indeed some supposed abuse by scientists. We should not, however, forget the powerful obligation there is to undertake, support, and participate (...) in scientific research, particularly biomedical research, and the powerful moral imperative that underpins these obligations. Now it is more imperative than ever to articulate and explain these obligations and to do so is the subject and the object of this paper.Let me present the question in its starkest form: is there a moral obligation to undertake, support and even to participate in serious scientific research? If there is, does that obligation require not only that beneficial research be undertaken but also that “we”, as individuals and “we” as societies be willing to support and even participate in research where necessary?Thus far the overwhelming answer given to this question has been “no”, and research has almost universally been treated with suspicion and even hostility by the vast majority of all those concerned with the ethics and regulation of research. The so called “precautionary approach”9 sums up this attitude, requiring dangers to be considered more likely and more serious than benefits, and assuming that no sane person would or should participate in research unless they had a pressing personal reason for so doing, or unless they were motivated by a totally impersonal altruism. International agreements and protocols—for example, the Declaration of Helsinki10 and the CIOMS Guidelines11—have been directed principally at …. (shrink)

In a recent article in this journal, Savulescu and Schuklenk defend and extend their earlier arguments against a right to medical conscientious objection in response to criticisms raised by Cowley. I argue that while it would be preferable to be less accommodating of medical conscientious than many countries currently are, Savulescu and Schuklenk's argument that conscientious objection is ‘simply unprofessional’ is mistaken. The professional duties of doctors should be defined in relation to the interests of patients and society, and for (...) reasons set out in this article, these may support limited accommodation of conscientious objection on condition that it does not impede access to services. Moreover, the fact that conscientious objection appears to involve unjustifiable compromise from the objector's point of view is not a reason for society not to offer that compromise. Arguing for robust enforcement of the no-impediment condition, rather than opposing conscientious objection in principle, may be a more effective way of addressing the harms resulting from an over-permissive conscientious objection policy. (shrink)

The Moral Habitat offers a new and systematic interpretation of Kant's moral and political philosophy. Herman introduces the idea of a moral habitat to examines the dynamic system of duties that exists between individuals and civic institutions.

The authors of the two main articles in this supplement recognize the enormous potential of learning health care systems. Their first article argues that the development of these systems calls into question existing guidelines and practices that treat clinical care and clinical research as distinct activities. Their second article proposes to replace this traditional approach with a new framework, one intended to promote two important goals: support the transformation to a learning health care system and help to ensure the ethical (...) appropriateness of the activities carried out within such a system. To promote these goals, the authors propose a framework consisting of seven obligations. The authors are aware that their framework does not provide much guidance for promoting their second goal. At first glance, the seven obligations also might appear to offer little in the way of promoting the first goal. In what way, then, is the proposed framework novel and transformative, as the authors claim? The answer appears to lie largely in how the authors interpret the sixth obligation in the framework—the obligation to conduct learning activities. (shrink)

Conscientious objection in health care is a form of compromise whereby health care practitioners can refuse to take part in safe, legal, and beneficial medical procedures to which they have a moral opposition (for instance abortion). Arguments in defense of conscientious objection in medicine are usually based on the value of respect for the moral integrity of practitioners. I will show that philosophical arguments in defense of conscientious objection based on respect for such moral integrity are extremely weak and, if (...) taken seriously, lead to consequences that we would not (and should not) accept. I then propose that the best philosophical argument that defenders of conscientious objection in medicine can consistently deploy is one that appeals to (some form of) either moral relativism or subjectivism. I suggest that, unless either moral relativism or subjectivism is a valid theory—which is exactly what many defenders of conscientious objection (as well as many others) do not think—the role of moral integrity and conscientious objection in health care should be significantly downplayed and left out of the range of ethically relevant considerations. (shrink)

The view that research with competent adults requires valid consent to be ethical perhaps finds its clearest expression in the Nuremberg Code, whose famous first principle asserts that “the voluntary consent of the human subject is absolutely essential.” In a similar vein, the United Nations International Covenant on Civil and Political Rights states that “no one shall be subjected without his free consent to medical or scientific experimentation.” Yet although some formulations of the consent principle allow no exceptions, others hold (...) that informed consent is not always strictly necessary for ethical research. The U.S. federal regulations known as the “Common Rule,” which govern research with human subjects, lists several conditions for waiving consent. However, neither guidance documents on the ethics of clinical research nor the literature in bioethics contains a general justification of research without consent. The purpose of this paper is to advance a justificatory framework that will explain why research without consent is permissible in paradigmatic cases and that can be useful in analyzing cases about which there is disagreement. We argue that research without consent can be justified on two grounds: if it stands to infringe no right of the participants and obtaining consent is impracticable, or if the gravity of the rights infringement is minor and outweighed by the expected social value of the research and obtaining consent is impracticable. (shrink)

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

BackgroundThe nature of the relationship between a clinical investigator and a research subject has generated considerable debate because the investigator occupies two distinct roles: clinician and scientist. As a clinician, the investigator has duties to provide the patient with optimal care and undivided loyalty. As a scientist, the investigator has duties to follow the rules, procedures and methods described in the protocol.Results and conclusionIn this article, I present a contextual approach to the investigator-subject relationship. The extent of the investigator's duty (...) to provide the patient/subject with clinical care can vary from one situation to the next, as a function of several factors, including: the research design, benefits and risks of the research; the subject's reasonable expectations, motivations, and vulnerabilities; the investigator's ability to benefit the subject; and the investigator's prior relationship with the subject. These and other factors need to be considered when determining the clinical investigator's obligations to provide clinical care to human research subjects. In some research contexts, the investigator has extensive clinical obligations to the patient/subject; in others, the investigator has minimal ones. (shrink)

Despite calls by some commentators for disclosing incidental fndings in genetics research, several factors weigh in favor of caution. The technology of genetics has the power to uncover a vast array of information. The most potent argument for restraint in disclosure is that much research is pursued without consent so that the individual participant may not know that research is being conducted at all. Often the work is done by investigators and at institutions with which the person has no prior (...) contact. Past practice is also relevant; genetics researchers historically have chosen not to disclose incidental fndings, of which misattributed paternity and pleiotropic alleles such as ApoE have been the most common. Many people choose not to have genetic tests when given a choice. It may be desirable to discuss the topic of incidental fndings when consent for research is obtained, but given the risk of unwanted surprise when there has been no prior discussion, the potential utility of incidental fndings should be very high before they are even ofered to individuals. (shrink)

There are countless variations on this theme. The call can come from one of your own physicians who was called by the investigator. Your physician may or may not be well informed on what the reported finding about Disease Y means or how to respond. DNA testing can reveal more than susceptibility to disease. People can learn that they do not have the biological connections — parentage or evidence of ethnic origin — that they thought they did.Colleagues who serve on (...) the Institutional Review Board in my institution tell me that they currently do not permit “cold calls” of the type portrayed in the opening paragraph. Such direct contacts have, however, occurred in the past, with or without the blessing of an IRB. Sharing findings with the individual’s physician, who is then supposed to serve as a learned and wise intermediary, is not without problems either, given that many physicians understand little about complex genetics. Yet the very existence of this project on managing incidental findings in research demonstrates that some people believe that some research findings ought to be available to participants. (shrink)

Moral injury emerged in the healthcare discussion quite recently because of the difficulties and challenges healthcare workers and healthcare systems face in the context of the COVID-19 pandemic. Moral injury involves a deep emotional wound and is unique to those who bear witness to intense human suffering and cruelty. This article aims to synthesise the very limited evidence from empirical studies on moral injury and to discuss a better understanding of the concept of moral injury, its importance in the healthcare (...) context and its relation to the well-known concept of moral distress. A scoping literature review design was used to support the discussion. Systematic literature searches conducted in April 2020 in two electronic databases, PubMed/Medline and PsychInfo, produced 2044 hits but only a handful of empirical papers, from which seven well-focused articles were identified. The concept of moral injury was considered under other concepts as well such as stress of conscience, regrets for ethical situation, moral distress and ethical suffering, guilt without fault, and existential suffering with inflicting pain. Nurses had witnessed these difficult ethical situations when faced with unnecessary patient suffering and a feeling of not doing enough. Some cases of moral distress may turn into moral residue and end in moral injury with time, and in certain circumstances and contexts. The association between these concepts needs further investigation and confirmation through empirical studies; in particular, where to draw the line as to when moral distress turns into moral injury, leading to severe consequences. Given the very limited research on moral injury, discussion of moral injury in the context of the duty to care, for example, in this pandemic settings and similar situations warrants some consideration. (shrink)

This new edition of Charles Fried's 'Medical Experimentation' includes a general introduction by Franklin Miller and the late Alan Wertheimer, a reprint of the 1974 text, an in-depth analysis by Harvard Law School scholars I. Glenn Cohen and D. James Greiner, and a new essay by Fried reflecting on the original text and how it applies to the contemporary landscape of medicine and medical experimentation.

The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research but largely (...) silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations of Research Ethics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promote research that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure that research is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connecting research to the goals of a just social order grounds a framework for assessing and managing research risk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceiving research ethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and international research. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (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)

The Right and the Good, a classic of twentieth-century philosophy by the great scholar Sir David Ross, is now presented in a new edition with a substantial introduction by Philip Stratton-Lake, a leading expert on Ross. Ross's book is the pinnacle of ethical intuitionism, which was the dominant moral theory in British philosophy for much of the nineteenth and early twentieth century. Intuitionism is now enjoying a considerable revival, and Stratton-Lake provides the context for a proper understanding of Ross's great (...) work today. (shrink)

The current prevailing view is that participation in biomedical research is above and beyond the call of duty. While some commentators have offered reasons against this, we propose a novel public goods argument for an obligation to participate in biomedical research. Biomedical knowledge is a public good, available to any individual even if that individual does not contribute to it. Participation in research is a critical way to support an important public good. Consequently, all have a duty to participate. The (...) current social norm is that individuals participate only if they have a good reason to do so. The public goods argument implies that individuals should participate unless they have a good reason not to. Such a shift would be of great aid to the progress of biomedical research, eventually making society significantly healthier and longer lived. (shrink)