The power of new medical technologies, the cultural authority of physicians, and the gendered power dynamics of many patient-physician relationships can all inhibit women's reproductive freedom. Often these factors interfere with women's ability to trust themselves to choose and act in ways that are consistent with their own goals and values. In this book Carolyn McLeod introduces to the reproductive ethics literature the idea that in reproductive health care women's self-trust can be undermined in ways that threaten their autonomy. Understanding (...) the importance of self-trust for autonomy, McLeod argues, is crucial to understanding the limits on women's reproductive freedom. -/- McLeod brings feminist insights in philosophical moral psychology to reproductive ethics, and to health-care ethics more broadly. She identifies the social environments in which self-trust is formed and encouraged. She also shows how women's experiences of reproductive health care can enrich our understanding of self-trust and autonomy as philosophical concepts. The book's theoretical components are grounded in women's concrete experiences. The cases discussed, which involve miscarriage, infertility treatment, and prenatal diagnosis, show that what many women feel toward themselves in reproductive contexts is analogous to what we feel toward others when we trust or distrust them. -/- McLeod also discusses what health-care providers can do to minimize the barriers to women's self-trust in reproductive health care, and why they have a duty to do so as part of their larger duty to respect patient autonomy. (shrink)

A predominant ethical view holds that physician‐investigators should conduct their research with therapeutic intent. And since a physician offering a therapy wouldn't prescribe second‐rate treatments, the experimental intervention and the best proven therapy should appear equally effective. "Clinical equipoise" is necessary. But this perspective is flawed. The ethics of research and of therapy are fundamentally different, and clinical equipoise should be abandoned.

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in (...) the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges. (shrink)

This work examines the concept of trust in the light of virtue theory, and takes our responsibility to be trustworthy as central. Rather than thinking of trust as risk-taking, Potter views it as equally a matter of responsibility-taking. Her work illustrates that relations of trust are never independent from considerations of power, and that asking ourselves what we can do to be trustworthy allows us to move beyond adversarial trust relationships and toward a more democratic, just, and peaceful society.

: The "difference position" holds that clinical research and therapeutic medical practice are sufficiently distinct activities to require different ethical rules and principles. The "similarity position" holds instead that clinical investigators ought to be bound by the same fundamental principles that govern therapeutic medicine—specifically, a duty to provide the optimal therapeutic benefit to each patient or subject. Some defenders of the similarity position defend it because of the overlap between the role of attending physician and the role of investigator in (...) a research trial. This overlap is maximal when the same physician occupies both roles with respect to a particular patient-subject. We address the ethical tensions inherent in that role conflict and argue that the tensions are real but manageable. The difference position provides a sound ethical framework within which to manage those tensions, while the similarity position is unsatisfactory because it seeks to deny the existence of the tensions. (shrink)

It is widely assumed that informing prospective subjects about the risks and possible benefits of research not only protects their rights as autonomous decisionmakers, but also empowers them to protect their own interests. Yet interviews with patient‐subjects conducted under the auspices of the Advisory Committee on Human Radiation Experiments suggest this is not always the case. Patient‐subjects often trust their physician to guide them through decisions on research participation. Clinicians, investigators, and IRBs must assure that such trust is not misplaced.

The term “therapeutic misconception” was coined in 1982 by Paul Appelbaum, Loren Roth, and Charles Lidz. Appelbaum and his colleagues interviewed participants in several psychiatric studies, including a drug trial with a placebo control arm. Appelbaum's group found that many people were unaware of the differences between participating in a study and receiving treatment in the clinical setting. Rather than understanding these differences, study participants tended to believe that therapy and research were governed by the same primary goal: to advance (...) the individual patient's best interests. Appelbaum's group labeled this mistaken belief the therapeutic misconception. (shrink)

Commentators often claim that medical research subjects are coerced into participating in clinical studies. In recent years, such claims have appeared especially frequently in ethical discussions of research in developing countries. Medical research ethics is more important than ever as we move into the 21st century because worldwide the pharmaceutical industry has grown so much and shows no sign of slowing its growth. This means that more people are involved in medical research today than ever before, and in the future (...) even more will be involved. However, despite the pressing need for reflection on research ethics, it is important to carefully identify the concerns we have about research. Otherwise we run the risk that the moral language we use, and which we hear other people use, may do our moral thinking for us. We argue that many recent claims about the occurrence of coercion in medical research are misguided and misuse the word "coercion." We try to identify the real problems, and urge people to attend carefully to the implications of their descriptions of moral problems in research. (shrink)

Trust relations in medicine are argued to be a requisite response to the special vulnerability of persons as patients. Even so, the problem of motivating trust remains a vital concern. On this score, it is argued that a strong motivation can be found in recognizing that professional self-interest actually entails cultivation of patient trust as a means to maintain professional self-governance. And while the initial move to restore trust must be provoked from such narrow concerns, the process of sustaining trust (...) will require educational initiatives aimed at restoring attitudes and skills suggestive of Percival's concept of empathic care. By including such initiatives, future waves of medical professionals are apt to sustain trust with deepened commitments to character, care, and trust as constitutive properties of their professional mission. (shrink)

When may a physician enroll a patient in clinical research? An adequate answer to this question requires clarification of trust-based obligations of the state and the physician-researcher respectively to the patient-subject. The state relies on the voluntarism of patient-subjects to advance the public interest in science. Accordingly, it is obligated to protect the agent-neutral interests of patient-subjects through promulgating standards that secure these interests. Component analysis is the only comprehensive and systematic specification of regulatory standards for benefit-harm evaluation by research (...) ethics committees (RECs). Clinical equipoise, a standard in component analysis, ensures the treatment arms of a randomised control trial are consistent with competent medical care. It thus serves to protect agent-neutral welfare interests of the patient-subject. But REC review occurs prior to enrolment, highlighting the independent responsibility of the physician-researcher to protect the agent-relative welfare interests of the patient-subject. In a novel interpretation of the duty of care, we argue for a “clinical judgment principle” which requires the physician-researcher to exercise judgment in the interests of the patient-subject taking into account evidence on treatments and the patient-subject‘s circumstances. (shrink)

In this paper I argue that it is morally important for doctors to trust patients. Doctors' trust of patients lays the foundation for medical relationships which support the exercise of patient autonomy, and which lead to an enriched understanding of patients' interests. Despite the moral and practical desirability of trust, distrust may occur for reasons relating to the nature of medicine, and the social and cultural context within which medical care is provided. Whilst it may not be possible to trust (...) at will, the conscious adoption of a trusting stance is both possible and warranted as the burdens of misplaced trust fall more heavily upon patients than doctors. (shrink)

: This paper provides a simultaneously reflexive and analytical framework to think about obstacles to truly informed consent in social science and biomedical research. To do so, it argues that informed consent often goes awry due to procedural misconceptions built into the research context. The concept of procedural misconception is introduced to describe how individuals respond to what is familiar in research settings and overlook what is different. In the context of biomedical research, procedural misconceptions can be seen to function (...) as root causes of therapeutic misconceptions. (shrink)

We have recently reached a watershed in the research community’s consideration of the ethics of research. The way is now open for a more nuanced discussion than the one of the last decade in which attention to legal and quasi-legal procedures for handling misconduct dominated. The new discussion of ethical issues focused on trustworthiness takes us beyond consideration of conduct that is straightforwardly permitted, forbidden or required, to consideration of criteria for responsible behavior. This paper develops an overview of the (...) subject of trustworthiness among researchers. It illustrates and discusses various types of betrayal and defections in research conduct, and locates these in relation to many of the situations discussed elsewhere in this issue. (shrink)

Background: “Therapeutic misconception” arises when human subjects interpret a clinical trial as aimed primarily at therapy rather than producing knowledge. Therapeutic misconceptions may be more prevalent in trials enrolling gravely ill subjects or involving novel and well publicised investigational agents.Objective: To examine the extent to which investigators express therapeutic optimism in phase 1 human gene transfer consent documents, whether highly active gene transfer researchers are more prone to expressing therapeutic optimism, and whether consent forms have grown more optimistic in their (...) descriptions of personal benefit over the last decade.Design: Content analysis was performed on 277 consent documents to measure the number of sentences describing possibility of benefit, terminology used for experimental agents, the proportion of statements describing personal versus societal benefits, and whether investigators attempted to thwart therapeutic misconceptions.Results: Consent forms generally used therapeutic terminology to describe study agents, devoted more sentences to describing possible personal benefits than to describing benefits to society, and infrequently explained that a particular benefit was unlikely. Consent documents used by highly active gene transfer researchers tended to portray significantly greater optimism about personal benefit than less active investigators, though they were also significantly more cautious with agent terminology. Finally, therapeutic optimism expressed in consent forms has declined over the past decade.Conclusions: Consent documents used in phase 1 gene transfer trials, although increasingly attentive to possible therapeutic misconceptions, are inappropriately optimistic about direct benefits of trial participation. Such optimism is expressed more emphatically in trials involving highly active gene transfer researchers as principal investigators. (shrink)