Informed Consent

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Thomas G. Gutheil - One of the best experts on this subject based on the ideXlab platform.

  • Informed Consent in psychotherapy.
    The American journal of psychiatry, 2001
    Co-Authors: John O. Beahrs, Thomas G. Gutheil
    Abstract:

    OBJECTIVE: The authors sought a rational approach to implementing Informed Consent within the practice of psychotherapy. METHOD: The history of Informed Consent in psychotherapy was reviewed to define a common synthesis that maximizes the potential benefits and minimizes the potential hazards. RESULTS: The benefits of Informed Consent in psychotherapy include fostering a positive treatment outcome through enhancing patient autonomy, responsibility, and self-therapeutic activity; lessening the risks of regressive effects and therapist liability; and helping the practice of psychotherapy extend beyond particular parochialisms by providing checks and balances on therapist judgments. The hazards include the unpredictability of interactional outcomes and the possibilities of replacing positive expectancy with negative suggestion, replacing a therapeutic alliance with a legalistic stance, and misimplying that patients are passive recipients. CONCLUSIONS: Practical implementation of Informed Consent in psychothe...

Dilip V Jeste - One of the best experts on this subject based on the ideXlab platform.

  • Enhancing Informed Consent for Research and Treatment
    Neuropsychopharmacology, 2001
    Co-Authors: Laura B Dunn, Dilip V Jeste
    Abstract:

    Increased scrutiny of Informed Consent calls for further research into decision making by patients who may be at risk for impairments. We review interventions designed to improve patient understanding of Informed Consent. A number of studies, within as well as outside psychiatry, have evaluated the effectiveness of specific interventions, as well as possible “predictors” of understanding of Consent, such as subject characteristics, psychiatric symptoms, and cognitive impairment. Deficits in patients’ understanding of Informed Consent may be partially related to poorly conceived, written, or organized Informed Consent materials; these deficits may be remediable with educational interventions. We find that effective interventions include corrected feedback, multiple learning trials, and more organized or simplified Consent forms. Educational levels of patients generally correlate with levels of understanding. Even among individuals with psychiatric illness or cognitive impairment, deficits in understanding can be remedied with certain educational interventions. A variety of interventions can enhance understanding of Informed Consent.

John O. Beahrs - One of the best experts on this subject based on the ideXlab platform.

  • Informed Consent in psychotherapy.
    The American journal of psychiatry, 2001
    Co-Authors: John O. Beahrs, Thomas G. Gutheil
    Abstract:

    OBJECTIVE: The authors sought a rational approach to implementing Informed Consent within the practice of psychotherapy. METHOD: The history of Informed Consent in psychotherapy was reviewed to define a common synthesis that maximizes the potential benefits and minimizes the potential hazards. RESULTS: The benefits of Informed Consent in psychotherapy include fostering a positive treatment outcome through enhancing patient autonomy, responsibility, and self-therapeutic activity; lessening the risks of regressive effects and therapist liability; and helping the practice of psychotherapy extend beyond particular parochialisms by providing checks and balances on therapist judgments. The hazards include the unpredictability of interactional outcomes and the possibilities of replacing positive expectancy with negative suggestion, replacing a therapeutic alliance with a legalistic stance, and misimplying that patients are passive recipients. CONCLUSIONS: Practical implementation of Informed Consent in psychothe...

Gideon Koren - One of the best experts on this subject based on the ideXlab platform.

  • Informed Consent in Pediatric Research
    Pediatric Drugs, 2015
    Co-Authors: Tom Leibson, Gideon Koren
    Abstract:

    Pediatric drug research is gradually becoming more and more accepted as the norm for assessing whether a drug is safe and efficacious for infants and children. The process of Informed Consent and assent for these trials presents a major challenge. The aim of this review is to map historical, ethical and legal aspects relevant to the challenges of Informed Consent in the setting of pediatric drug research. The impact of age, level of maturity and life circumstances on the process of obtaining Informed Consent as well as the relations between Consent and assent are discussed. There appears to be a lack of regulatory clarity in the area of pediatric clinical trials; while numerous statements have been made regarding children’s rights to autonomy and their ability to care for themselves and for younger ones, the ever changing status of adolescence is still difficult to translate to Informed Consent. This may delay scientific and clinical advancement for children who are at the very junction of being independent and not needing parental permission. Obtaining Consent and assent for pediatric clinical trials is a delicate matter, as both parent and child need to agree to participate. The appropriate transfer of information to guardians and the children, especially concerning potential risks and benefits, is at the heart of Informed Consent, as it serves to protect both patient and physician. As many adults lack health literacy, one must ensure that guardians receive relevant information at a level and in forms they can understand regarding the trials their children are asked to participate in.

Lisa S. Parker - One of the best experts on this subject based on the ideXlab platform.

  • Informed Consent - The Limits of Informed Consent
    Informed Consent, 2001
    Co-Authors: Jessica Wilen Berg, Paul S. Appelbaum, Charles W. Lidz, Lisa S. Parker
    Abstract:

    It will come as no surprise to anyone who has read this far to know that we are enthusiastic supporters of Informed Consent. We believe that entitlement to adequate information and the right to make choices about one’s medical treatment are fundamental ethical rights that are every bit as important in the healthcare arena as, for example, free speech and due process of law are in the wider society. Moreover, Informed Consent does not merely have deontological value. We have argued that, if done correctly, Informed Consent can often lead to better doctor-patient relationships, better patient adherence to treatment plans, and a fuller understanding of the disease process on the part of the healthcare provider. Yet it is also important to understand the limits of Informed Consent so we do not try to make it do what it cannot do. For example, although Informed Consent may help in managing treatment, by itself it does not cure illness. The claims that have been made for Informed Consent, however, are sometimes almost that extravagant. Informed Consent has been suggested as the means to protect patients from poor care (1-3), including involuntary care (4), and as a means to improve the outcomes of care (5,6). It has been proposed as the solution to the problems of nursing homes (7) and as a device for compensating patients who are harmed by poor medical treatment (8). None of these are entirely specious ideas. Several of them, indeed, may be correct in part, but it is important for us to understand what Informed Consent cannot do as well as what it can. Just as free speech does not guarantee good government and due process of law does not guarantee justice, so too Informed Consent cannot solve all of the problems of the healthcare system. In this chapter we explore some of the limitations of Informed Consent. Specifically, we want to suggest four propositions. First, Informed Consent is a mechanism for improving communication and decision making among healthcare providers and patients.

  • Informed Consent - The Concept and Ethical Justification of Informed Consent
    Informed Consent, 2001
    Co-Authors: Jessica Wilen Berg, Paul S. Appelbaum, Charles W. Lidz, Lisa S. Parker
    Abstract:

    The values underlying Informed Consent—autonomy and concern for individual well-being—are deeply embedded in American culture, in our religious traditions, and in Western moral philosophy. It is not surprising that Informed Consent is a cornerstone doctrine of contemporary medical ethics and health law in the United States. There is widespread agreement about the importance of the concept, goals, and practice of Informed Consent. Even when there are differences of opinion about the best way to implement Informed Consent in clinical practice, or when there is debate about the core meaning of the concept, the attention paid to these controversies only reinforces recognition of the importance of Informed Consent in contemporary health care and medical research. The concept of Informed Consent has multiple meanings and draws its ethical justification from several sources. Some consider Informed Consent to be synonymous with the ideal of shared decision making between physician and patient, or at least to embody this ideal (1). Others emphasize that Informed Consent is a particular sort of decision made by a particular sort of decision maker (2). Still others focus on Informed Consent as a norm-governed social practice that is embedded in social institutions, specifically law and medicine. This chapter discusses these different but often overlapping conceptions of Informed Consent. From a patient’s perspective, Informed Consent appears to be a right, while from the physician’s viewpoint, it is a duty or obligation. In fact, Informed Consent imposes responsibilities on both patient and physician. The relationship between ethical rights and duties, as well as the possibility of conflict between them, form another topic of this chapter. In this chapter we also discuss the ethical values and goals that underlie Informed Consent. Informed Consent is grounded in some of the ethical values most prized in American society and Western ethical thought, especially autonomy— auto from the Greek word for self, and nomos from the Greek for rule—literally “self-rule.” It is interesting to observe how the fundamental goals of Informed Consent usually coincide, but sometimes conflict, both in theory and as manifest in particular cases.

  • Informed Consent - Informed Consent: Framing the Questions
    Informed Consent, 2001
    Co-Authors: Jessica Wilen Berg, Paul S. Appelbaum, Charles W. Lidz, Lisa S. Parker
    Abstract:

    What is Informed Consent? The answer may seem self-evident only to those who have yet to explore the many meanings of the term. Informed Consent refers to legal rules that prescribe behaviors for physicians and other healthcare professionals in their interactions with patients and provide for penalties, under given circumstances, if physicians deviate from those expectations; to an ethical doctrine, rooted in our society’s cherished value of autonomy, that promotes patients’ right of self-determination regarding medical treatment; and to an interpersonal process whereby these parties interact with each other to select an appropriate course of medical care. Informed Consent is each of these things, yet none of them alone. As a theory based on ethical principles, given effect by legal rulings and implemented by clinicians, it has been haunted by its complex lineage. When legal principles and ethical values conflict, which should take precedence? When clinical interests appear to be served by neither legal nor ethical concerns, which interests should be compromised and to what degree? The vast literature on Informed Consent, found in journals and books of medicine, law, bioethics, philosophy, and public policy, has been stimulated by the need to create a workable doctrine that can accommodate values that to many observers are in an irremediable state of conflict. The conflicts in theory and the need to resolve them in practice are the subjects of this book. Theory is the focus of the first half of the volume; practice is the topic of the second. Seeking to understand the fascinating theoretical problems requires us to grapple with some of the most difficult ethical and policy issues facing our society today. But let us state at the outset our belief that the clinician on the front lines need not be paralyzed by differences of opinion among legal and ethical theorists. Through the vaguely translucent wall of expertise behind which the discussion about the proper shape of the Informed Consent doctrine has taken place, a reasonable approach to Informed Consent in the clinician-patient relationship can be discerned. Our most important and challenging task in this book is to make that approach evident.

  • Informed Consent - Critical Approaches to the Law of Informed Consent
    Informed Consent, 2001
    Co-Authors: Jessica Wilen Berg, Paul S. Appelbaum, Charles W. Lidz, Lisa S. Parker
    Abstract:

    A number of goals have been posited for the legal doctrine of Informed Consent. One author, for example, highlights four goals: “1) an ethical goal, in which the law promotes patient autonomy; 2) a decision making goal, in which the law promotes the ability of patients to make medical decisions; 3) a regulatory goal, in which the law attempts to control physicians’ disclosure practices; and 4) a compensatory goal, in which the common law functions as a mechanism to provide monetary compensation for injuries” (1). Another author posits six goals: “1) promoting individual autonomy; 2) respecting human dignity; 3) encouraging professional self-scrutiny; 4) promoting rational decisionmaking; 5) avoiding deceit and coercion; and 6) educating the public” (2). According to critics, the result has been a doctrine and a set of practices that compromise all values and satisfy none in their entirety (1). But commentators who have analyzed the law and practice of Informed Consent have each generally represented one point of view to the exclusion of others. The resulting debate over Informed Consent among healthcare practitioners, legal experts, and ethicists should come as no surprise. As long as one relies on a single perspective, it is remarkably easy to find critical things to say about Informed Consent. Those who would elevate any single value above all others, and steadfastly resist compromise, usually can offer a powerful, even devastating, analysis of the current state of affairs. In this chapter we focus on three critiques—a perspective concerned with promoting individual autonomy, an approach that emphasizes the value of health, and a perspective that places primary emphasis on encouraging discourse and interaction between caregivers and patients—and assess their validity from a perspective that recognizes that the doctrine of Informed Consent must accommodate a number of competing interests and values. The most trenchant criticism of the state of Informed Consent law today focuses on the discrepancies between the goals highlighted by the ethical theories of Informed Consent—primarily, the enhancement of individual autonomy in making medical decisions—and the practical effects of the current system.