Although there is extensive information about why people participate in clinical trials, studies are largely based on quantitative evidence and typically focus on single conditions. Over the last decade investigations into why people volunteer for health research have become increasingly prominent across diverse research settings, offering variable based explanations of participation patterns driven primarily by recruitment concerns. Therapeutic misconception and altruism have emerged as predominant themes in this literature on motivations to participate in health research. This paper contributes to more (...) recent qualitative approaches to understanding how and why people come to participate in various types of health research. We focus on the experience of participating and the meanings research participation has for people within the context of their lives and their health and illness biographies. (shrink)

Some have characterized patients living with intractable pain as a vulnerable population in both clinical and research settings. Labeling the population as vulnerable, however, does not provide clarity regarding the potential risks that they face when they participate in research. Instead, research vulnerability for patients in pain is a function of an interaction between their pain conditions and elements of the research enterprise. Therefore, the identification of potential risks requires consideration not only of characteristics of patients with chronic pain, but (...) also consideration of features of researchers, the quality of institutional oversight, and the medical/social environment within which the research is conducted. This paper provides an analysis of those risks and provides some suggestions as to how the risks might be better managed. (shrink)

In recent years, there has been a particular emphasis placed on conducting randomized controlled trials (RCTs) that compare the relative efficacy of psychosocial and pharmacological interventions. This article addresses relevant ethical considerations in the conduct of these treatment trials, with a focus on RCTs with children. Ethical concerns, including therapeutic misconception, treatment preference, therapeutic equipoise, structure of treatments, and balancing risks versus benefits, are introduced through a clinical scenario and discussed as they relate to psychotherapy versus medication RCTs. In each (...) case, suggestions are made for researchers seeking to minimize the impact of these ethical concerns on research participants. (shrink)

The effects of research ethics training on medical students' attitudes about clinical research are examined. A preliminary randomized controlled trial evaluated 2 didactic approaches to ethics training compared to a no-intervention control. The participant-oriented intervention emphasized subjective experiences of research participants. The criteria-oriented intervention emphasized specific ethical criteria for analyzing protocols. Compared to controls, those in the participant-oriented intervention group exhibited greater attunement to research participants' attitudes related to altruism, trust, quality of relationships with researchers, desire for information, hopes about (...) participation and possible therapeutic misconception, importance of consent forms, and deciding quickly about participation. The participant-oriented group also agreed more strongly that seriously ill people are capable of making their own research participation decisions. The criteria-oriented intervention did not affect learners' attitudes about clinical research, ethical duties of investigators, or research participants' decision making. An empathy-focused approach affected medical students' attunement to research volunteer perspectives, preferences, and attributes, but an analytically oriented approach had no influence. These findings underscore the need to further examine the differential effects of empathy-versus analytic-focused approaches to the teaching of ethics. (shrink)

Randomised controlled trials (RCTs) sometimes recruit participants who are desperate to receive the experimental treatment. This paper defends the practice against three arguements that suggest it is unethical first, desperate volunteers are not in equipoise. Second clinicians, entering patients onto trials are disavowing their therapeutic obligation to deliver the best treatment; they are following trial protocols rather than delivering individualised care. Research is not treatment; its ethical justification is different. Consent is crucial. Third, desperate volunteers do not give proper consent: (...) effectively, they are coerced. This paper responds by advocating a notion of equipoise based on expert knowledge and widely shared values. Where such collective, expert equipoise exists there is a prima facie case for an RCT. Next the paper argues that trial entry does not involve clinicians disavowing their therapeutic obligation; individualised care based on insufficient evidence is not in patients best interest. Finally, it argues that where equipoise exists it is acceptable to limit access to experimental agents; desperate volunteers are not coerced because their desperation does not translate into a right to receive what they desire. (shrink)

BackgroundStudies have shown that research participants fail to appreciate the difference between research and medical care, labeling such phenomenon as a "therapeutic misconception" (TM). Since research activity involving human participants is increasing in the Middle East, qualitative research investigating aspects of TM is warranted. Our objective was to assess for the existence of therapeutic misconception amongst Egyptians.MethodsStudy Tool: We developed a semi-structured interview guide to elicit the knowledge, attitudes, and perspectives of Egyptians regarding medical research.Setting: We recruited individuals from the (...) outpatient settings (public and private) at Ain Shams University in Cairo, Egypt.Analysis: Interviews were taped, transcribed, and translated. We analyzed the content of the transcribed text to identify the presence of a TM, defined in one of two ways: TM1 = inaccurate beliefs about how individualized care can be compromised by the procedures in the research and TM2 = inaccurate appraisal of benefit obtained from the research study.ResultsOur findings showed that a majority of participants (11/15) expressed inaccurate beliefs regarding the degree with which individualized care will be maintained in the research setting (TM1) and a smaller number of participants (5/15) manifested an unreasonable belief in the likelihood of benefits to be obtained from a research study (TM2). A total of 12 of the 15 participants were judged to have expressed a TM on either one of these bases.ConclusionThe presence of TM is not uncommon amongst Egyptian individuals. We recommend further qualitative studies investigating aspects of TM involving a larger sample size distinguished by different types of illnesses and socio-economic variables, as well as those who have and have not participated in clinical research. (shrink)

In his article “The Real Problem of Equipoise,” Chiong (2006) advances arguments that culminate in an assertion that the equipoise requirement “must be given uP′ if international clinical research...

The therapeutic misconception has been seen as presenting an ethical problem because failure to distinguish the aims of research participation from those receiving ordinary treatment may seriously undermine the informed consent of research subjects. Hence, most theoretical and empirical work on the problems of the therapeutic misconception has been directed to evaluate whether, and to what degree, this confusion invalidates the consent of subjects. We argue here that this focus on the understanding component of informed consent, while important, might be (...) too narrow to capture the ethical complexity of the therapeutic misconception. We show that concerns about misplaced trust and exploitation of such trust are also relevant, and ought to be taken into account, when considering why the therapeutic misconception matters ethically. (shrink)

To date, ethics discussions about stem cell research overwhelmingly have centered on the morality and acceptability of using human embryonic stem cells. Governments in many jurisdictions have now answered these “first-level questions” and many have now begun to address ethical issues related to the donation of cells, gametes, or embryos for research. In this commentary, we move beyond these ethical concerns to discuss new themes that scientists on the forefront of NRM development anticipate, providing a preliminary framework for further discussion (...) between scientists and ethicists. Fostering strong partnerships between neuroscientists and ethicists that operate and collaborate within this evolving framework will maximize the translation of NRM discoveries on the brain into cures that are safe and address the needs of science and society. (shrink)

Twenty-five years after the term "therapeutic misconception’ (TM) first entered the literature, most commentators agree that it remains widespread. However, the majority of scholarly attention has focused on the reasons why a patient cum human subject might confuse the goals of research with the goals of therapy. Although this paper addresses the social and cultural factors that seem to animate the TM among subjects, it also fills a niche in the literature by examining why investigators too might operate under a (...) similar confusion. In framing these issues, the paper expressly adopts a Wittgensteinian approach to evaluating the TM, suggesting that interlocutors do not need any analytic definition of the TM to use the term meaningfully in thinking about the moral implications of the TM in practice. (shrink)

The medical profession contains five “spheres of morality”: clinical care, clinical research, scientific knowledge, population health, and the market. These distinct sets of normative commitments require physicians to act in different ways depending on the ends of the activity in question. For example, a physician-scientist emphasizes patients’ well-being in clinic, prioritizes the scientific method in lab, and seeks to maximize shareholder returns as a board member of a pharmaceutical firm. Physicians increasingly occupy multiple roles in healthcare and move between them (...) frequently, creating the possibility of conflict between the ethical obligations of their various roles. This paper examines the entire moral landscape of medicine through the lens of role morality. It develops a novel framework that helps physicians recognize how their moral commitments depend on the nature and context of the situation, clarifies ethical conflicts that physicians face, and concludes with ideas for resolving these conflicts. (shrink)