Client preferences for informed consent information

Thirty-five current therapy clients, 47 former clients, and 42 college students with no therapy experience rated 27 items in terms of importance for inclusion in informed consent discussions. The current and former client samples rated information about inappropriate therapeutic techniques, confidentiality, and the risks of alternative treatments as most important, and information about the personal characteristics of the therapist and the therapist's degree as least important. The results of this study provide evidence for differential informed consent disclosure practices.     

Trial design and informed consent for a clinic-based study with a treatment as usual control arm

Employing the National Institute of Mental Health-funded Prevention of Suicide in Primary Care Elderly Collaborative Trial as a case study, we discuss 2 sets of ethical issues: obtaining informed consent for a clinic-based intervention study and using treatment as usual (TAU) as the control condition. We then address these ethical issues in the context of the debate about the quality improvement efforts of health care organizations. Our analysis reveals the tension between ethics and scientific integrity involved with using TAU as a control condition and the difficulty in designing high-quality research in a community-based setting.     

The elusive goal of informed consent by adolescents

While parents have traditionally provided proxy consent for minors to participate in research, this has proven inadequate for adolescents who are mentally and emotionally capable of making their own decisions. Research has proven that even young children, and certainly most adolescents, are developmentally prepared to make such decisions for themselves. The author challenges the assumption that both consent and assent are static concepts, and proposes that a sliding scale of competence be created to ascertain the adolescent's comprehension of the proposed research by shifting the burden of proof to those who believe a particular adolescent is unable to provide informed consent.     

The structure of informed consent in psychiatric research

The manner in which the informed consent process is structured was explored by means of intensive interviews with 17 experienced psychiatric researchers. Despite differing views on informed consent, investigators displayed a commonality of practice. Most investigators were themselves not usually involved in obtaining consents, relegating the process to lower-level assistants. They did not closely monitor the process and generally were unaware of problems that may have arisen. Most protocols called for repeat contact with patients so that a relationship would develop and information could be provided before obtaining a formal consent. The actual signing of a consent form often reflected a decision that had been made much earlier in the process. These findings have significance for both sides in the dispute over informed consent in research. Those who favor tighter controls over psychiatric research will have to consider the implications of monitoring, without destroying, a prolonged and complicated process. Those who argue for a reliance on investigators' integrity must deal with the apparent lack of involvement most investigators have in the consent process.     

The physician's influence on informed consent for bone marrow transplantation

The influence of physician judgment on the disclosure, competency, understanding, voluntariness, and decision aspects of informed consent for bone marrow transplantation are described. Ethical conflicts which arise from the amount and complexity of the information to be disclosed and from the barriers of limited time, patient anxiety and lack of prior relationship between patient and physician are discussed. The role of the referring physician in the decision-making is considered. Special ethical issues which arise with use of healthy related bone marrow donors are discussed, as is the physician's discretion in raising questions of competency. It is concluded that in this setting, regardless of the theoretical goals of the physician, patients appear to utilize informed consent discussions to assess their capacity to trust the physician rather than as a time to weigh the large amount of relevant data. The conscientious physician best serves the patient with recommendation of the best medical alternative rather than with attempts to remain neutral.     

Enhancing the informed consent process: a conceptual overview

Concern about limitations in the ability to give valid informed consent among certain groups of individuals has led to increased interest in defining, measuring, and enhancing consent-related decision-making. In this overview, we summarize issues related to the definition of decision-making capacity, discuss methods that have been used to assess decision-making abilities and other aspects of informed consent, and briefly describe studies that aim to understand variation in different elements of informed consent. We then review strategies that have been used with the intent of improving aspects of the informed consent process. Finally, we provide an outline of areas that are in need of future studies in order to reach the ultimate goal of preserving as much autonomy as possible in at-risk populations, while still achieving valuable research and treatment goals.     

The therapeutic misconception and our models of competency and informed consent

The doctrine of informed consent rests on empirical claims. This is true particularly of what commentators have characterized as the "strong" model of informed consent. This model assumes that if adequate information is given to a competent individual, understanding will result and, permitted to make a voluntary decision, the individual will make a rational decision. However, the "therapeutic misconception" posits that individuals may confuse the goals of research with those of treatment and may make decisions that do not rest on adequate understanding. This article reviews research suggesting that this may in fact be true, and concludes that, as a result, traditional notions of informed consent may not yield results consistent with the assumptions on which the doctrine of informed consent rests.     

Shading the truth in seeking informed consent for research purposes

I want to argue for two propositions. First, I suggest that what some researchers may take to be a simple trade-off between minor violations of the truth for the sake of access to far greater truths represents a profound miscalculation with far-reaching and cumulative reverberations. Second, I submit that today's research environment, as demanding, competitive, and sometimes bewildering as it is, offers genuine scope for what Murdoch calls truth-seeking, for imaging and questioning, and for relating to facts through both truth and truthfulness; but that, in so doing, it presents hard choices with respect to methods, and, in turn, to personal integrity--not only in particular research projects but also with respect to that fragile research environment in its own right.     

An ethics of expertise based on informed consent

Ethicists widely accept the notion that scientists have moral responsibilities to benefit society at large. The dissemination of scientific information to the public and its political representatives is central to many of the ways in which scientists serve society. Unfortunately, the task of providing information can often give rise to moral quandaries when scientific experts participate in politically charged debates over issues that are fraught with uncertainty. This paper develops a theoretical framework for an “ethics of expertise” (EOE) based on the notion that scientists have responsibilities to provide information in a way that promotes autonomous decision-making on the part of the public and its representatives. Moreover, insofar as the principle of informed consent has developed in biomedical ethics as a way for physicians to promote autonomous decision-making on the part of their patients, this paper suggests that the informed-consent concept may suggest a set of criteria and guidelines that can help scientists to fulfill their similar ethical responsibilities to the public. In order to illustrate how the resulting EOE could provide practical guidance for scientific experts, the paper examines a case study involving the dissemination of information about the low-dose biological effects of toxic chemicals and carcinogens.