Patient engagement in healthcare is increasingly discussed in the literature, and initiatives engaging patients in quality improvement activities, organizational design, governance, and research are becoming more and more common and have even become mandatory for certain health institutions. Here we discuss a number of ethical challenges raised by this engagement from patients from the perspectives of research, organizational/quality improvement practices, and patient experiences, while offering preliminary recommendations as to how to address them. We identified three broad categories of ethical issues (...) that intersect between the different types of patient engagement: (1) establishing a shared vision about goals of patient engagement and respective roles; (2) the process and method of engaging with patients; and (3) practical aspects of patient engagement. To explain these issues, we build from our personal, professional, and academic experiences, as well as traditions such as pragmatism and hermeneutics that stress the importance of participation, empowerment, and engagement. Patient engagement can be highly valuable at numerous levels, but particular attention should be paid to the process of engaging with patients and related ethical issues. Some lessons from the literature on the ethics of participatory research can be translated to organizational and quality improvement practices. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of (...) this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

In this article, I present a contractualist conception of human-participant research ethics, arguing that the most appropriate source of the rights and responsibilities of researcher and participant is the contractual understanding between them. This conception appears to explain many of the more fundamental ethical incidents of human-participant research. I argue that a system of contractual rights and responsibilities would allow a great deal of research that has often been felt to be ethically problematic, such as research involving deception, concealed research, (...) and research on dependent populations. However, in defining the conditions under which such research should be permissible, my contractualist theory also makes it clear that there are limits-and explains what those limits are-to the propriety of such research. (shrink)

Problems with clinical research that create conflicts between doctors' therapeutic and research obligations may be fueled by a rigid view of science as determiner of truth, a heavy reliance on statistics, and certain features of randomized clinical trials. I suggest some creative, feminist approaches to such research and explore ways to provide choice for patients and to use values in directing both therapy and science - to enhance the effectiveness of each.

Well before patient-centered or patient-controlled research became trendy, and earlier than calls to preferentially refer to research subjects as participants, Bob Veatch wrote “The Patient as Partner” Veatch presciently argued that research patients should not be thought of as passive subjects nor material from which to obtain data, but rather as partners in discovery. In this manuscript, I will explore Veatch’s conception of patient as partner in research and how that idea has evolved and been implemented over time and consider (...) some of the remaining challenges. Complexities of patient partnership include: clarifying the types of research in which patient partnership is most appropriate, recognizing the various possible levels of patient engagement in each case, avoiding tokenism and striving for respectful partnership, and keeping in mind the appropriate implementation of protections and safeguards. Bob Veatch would be pleased with the progress that has been made in creating research partnerships with patients, while also undoubtedly pushing us to continue to do better. (shrink)

The involvement of children in non-beneficial clinical research is extremely important for improving pediatric care, but its ethical acceptability is still disputed. Therefore, various pro-research justifications have been proposed throughout the years. The present essay aims at contributing to the on-going discussion surrounding children’s participation in non-beneficial clinical research. Building on Wendler’s ‘contribution to a valuable project’ justification, but going beyond a risk/benefit analysis, it articulates a pro-research argument which appeals to a phenomenological view on the body and vulnerability. It (...) is claimed that children’s bodies are not mere physical objects, but body-subjects due to which children, as persons, can contribute to research that may hold no direct clinical benefit to them even before they can give informed consent. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim (...) of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

Discussions on the ethics and regulation of clinical research have a great deal to say about the responsibilities of investigators, sponsors, research institutions and institutional review boards, but very little about the responsibilities of research participants. In this article, we discuss the responsibilities of participants in clinical research. We argue that competent adult participants are responsible for complying with study requirements and fulfilling other obligations they undertake when they make an informed choice to enrol in a study. These responsibilities are (...) based on duties related to promise-keeping, avoiding harm to one's self or others, beneficence and reciprocity. Investigators and research staff should inform participants about their responsibilities during the consent process, and should stress the importance of fulfilling study requirements. They should address any impediments to compliance, and they may provide participants with financial incentives for meeting study requirements. In very rare cases, coercive measures may be justified to prevent immanent harm to others resulting from non-compliance with study requirements. (shrink)

A diverse group of scholars reflect on the scholarship of Robert M. Veatch, the breadth of which is unmatched in modern day bioethics. Essays were written by both philosophers and clinician-philosophers, by contemporaries and mentees. They span the breadth of Bob’s work and include analyses of his ideas about death, dying and organ transplantation, human experimentation and research ethics, disability, equality and justice, the doctor-patient relationship, the history of bioethics, as well as his pedagogical approach to teaching bioethics to clinicians (...) across the health care spectrum. Recognition of Bob’s influence in the modern field of bioethics and the challenges that persist are clearly identified. (shrink)

Like many trained in philosophy, we greatly value the work of those scholars with the courage to espouse contrarian views, particularly when the ideas in dispute lie at the very heart of entrenched...

Academic medical centers and drug manufacturers have traditionally occupied very distinct positions with regard to public trust. As collaborations among medical researchers and pharmaceutical companies expand, however, worries about the aggressive pursuit of profit that has tarnished the reputation of the pharmaceutical industry may be transferred to medical institutions and clinical investigators, suggesting to some that biomedical research is more about increasing profit than promoting public health. Consequently, when medical institutions forge research collaborations with industry they should be mindful of (...) the potential for these relationships to erode public confidence in the integrity of clinical research.Recent events have heightened concerns about the financing of clinical research. These include the widely publicized deaths of several research volunteers, scandals at the nation's largest funder of biomedical research, and evidence of fabricated research findings in prominent medical journals. These unfortunate events have prompted many to re-examine strategies for managing industry relationships and the financial conflicts of interest they may create. (shrink)

This essay analyzesexploitation in biomedical research in terms ofthree basic elements: harm, disrespect, orinjustice. There are also degrees ofexploitation, ranging from highly exploitationto minimally exploitation. Althoughexploitation is prima facie wrongful,some exploitative research studies are morallyjustified, all things considered. The reasonan exploitative study can still be ethical isthat other moral considerations, such as theautonomy of the research subject or the socialbenefits of research, may sometimes justifystudies that are minimally exploitative. Calling a research project exploitative doesnot end the debate about the merits (...) of thestudy but invites one to ask additionalquestions about how the study is exploitative,and whether the study is justifiablenevertheless. (shrink)