Informed Consent and Health Literacy
Informed Consent and Health Literacy

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2015-03-04

Total Pages: 228

ISBN-13: 0309317304

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Informed consent - the process of communication between a patient or research subject and a physician or researcher that results in the explicit agreement to undergo a specific medical intervention - is an ethical concept based on the principle that all patients and research subjects should understand and agree to the potential consequences of the clinical care they receive. Regulations that govern the attainment of informed consent for treatment and research are crucial to ensuring that medical care and research are conducted in an ethical manner and with the utmost respect for individual preferences and dignity. These regulations, however, often require - or are perceived to require - that informed consent documents and related materials contain language that is beyond the comprehension level of most patients and study participants. To explore what actions can be taken to help close the gap between what is required in the informed consent process and communicating it in a health-literate and meaningful manner to individuals, the Institute of Medicine's Roundtable on Health Literacy convened a one-day public workshop featuring presentations and discussions that examine the implications of health literacy for informed consent for both research involving human subjects and treatment of patients. Topics covered in this workshop included an overview of the ethical imperative to gain informed consent from patients and research participants, a review of the current state and best practices for informed consent in research and treatment, the connection between poor informed consent processes and minority underrepresentation in research, new approaches to informed consent that reflect principles of health literacy, and the future of informed consent in the treatment and research settings. Informed Consent and Health Literacy is the summary of the presentations and discussion of the workshop.

Informed Consent and Health
Informed Consent and Health

Author: Thierry Vansweevelt

Publisher: Edward Elgar Publishing

Published: 2020-04-24

Total Pages: 293

ISBN-13: 1788973429

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Informed consent is the legal instrument that purports to protect an individual’s autonomy and defends against medical arbitrariness. This illuminating book investigates our evolving understanding of informed consent from a range of comparative and international perspectives, demonstrating the diversity of its interpretations around the world. Chapters offer a nuanced analysis of the problems that impede the understanding and implementation of the concept of informed consent and explore the contemporary challenges that continue to hinder both the patient and the medical community.

Registries for Evaluating Patient Outcomes
Registries for Evaluating Patient Outcomes

Author: Agency for Healthcare Research and Quality/AHRQ

Publisher: Government Printing Office

Published: 2014-04-01

Total Pages: 385

ISBN-13: 1587634333

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This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Informed Consent
Informed Consent

Author: S. Wear

Publisher: Springer Science & Business Media

Published: 2012-12-06

Total Pages: 190

ISBN-13: 9401581223

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Substantial efforts have recently been made to reform the physician-patient relationship, particularly toward replacing the `silent world of doctor and patient' with informed patient participation in medical decision-making. This 'new ethos of patient autonomy' has especially insisted on the routine provision of informed consent for all medical interventions. Stronly supported by most bioethicists and the law, as well as more popular writings and expectations, it still seems clear that informed consent has, at best, been received in a lukewarm fashion by most clinicians, many simply rejecting what they commonly refer to as the `myth of informed consent'. The purpose of this book is to defuse this seemingly intractable controversy by offering an efficient and effective operational model of informed consent. This goal is pursued first by reviewing and evaluating, in detail, the agendas, arguments, and supporting materials of its proponents and detractors. A comprehensive review of empirical studies of informed consent is provided, as well as a detailed reflection on the common clinician experience with attempts at informed consent and the exercise of autonomy by patients. In the end, informed consent is recast as a management tool for pursuing clinically and ethically important goods and values that any clinician should see as meriting pursuit. Concurrently, the model incorporates a flexible, anticipatory approach that recognizes that no static, generic ritual can legitimately pursue the quite variable goods and values that may be at stake with different patients in different situations. Finally, efficiency of provision is addressed by not pursuing the unattainable and ancillary. Throughout, the traditional principle of beneficence is appealed to toward articulating an operational model of informed consent as an intervention that is likely to change outcomes at the bedside for the better.

Beyond the HIPAA Privacy Rule
Beyond the HIPAA Privacy Rule

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2009-03-24

Total Pages: 334

ISBN-13: 0309124999

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In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

Rethinking Informed Consent in Bioethics
Rethinking Informed Consent in Bioethics

Author: Neil C. Manson

Publisher: Cambridge University Press

Published: 2007-03-29

Total Pages: 15

ISBN-13: 1139463209

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Informed consent is a central topic in contemporary biomedical ethics. Yet attempts to set defensible and feasible standards for consenting have led to persistent difficulties. In Rethinking Informed Consent in Bioethics, first published in 2007, Neil Manson and Onora O'Neill set debates about informed consent in medicine and research in a fresh light. They show why informed consent cannot be fully specific or fully explicit, and why more specific consent is not always ethically better. They argue that consent needs distinctive communicative transactions, by which other obligations, prohibitions, and rights can be waived or set aside in controlled and specific ways. Their book offers a coherent, wide-ranging and practical account of the role of consent in biomedicine which will be valuable to readers working in a range of areas in bioethics, medicine and law.

Family-Oriented Informed Consent
Family-Oriented Informed Consent

Author: Ruiping Fan

Publisher: Springer

Published: 2015-03-05

Total Pages: 281

ISBN-13: 3319121200

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This volume addresses the proper character of patient informed consent to medical treatment and clinical research. The goal is critically to explore the current individually oriented approach to informed consent which grew out of the dominant bioethics movement that arose in the United States in the 1970s. In contrast to that individually oriented approach, this volume explores the importance of family-oriented approaches to informed consent for medical treatment and clinical research. It draws on both East Asian moral resources as well as a critical response to the ways in which the practice of informed consent has developed in the United States

Data Analytics in Medicine
Data Analytics in Medicine

Author: Information Resources Management Association

Publisher: Medical Information Science Reference

Published: 2019-11-18

Total Pages: 2250

ISBN-13: 9781799812043

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""This book examines practical applications of healthcare analytics for improved patient care, resource allocation, and medical performance, as well as for diagnosing, predicting, and identifying at-risk populations"--

Informed Consent to Psychoanalysis
Informed Consent to Psychoanalysis

Author: Elyn R. Saks

Publisher: Fordham Univ Press

Published: 2013-02-19

Total Pages: 87

ISBN-13: 0823249786

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The goal of this book is to shed psychoanalytic light on a concept—informed consent—that has transformed the delivery of health care in the United States. Examining the concept of informed consent in the context of psychoanalysis, the book first summarizes the law and literature on this topic. Is informed consent required as a matter of positive law? Apart from statutes and cases, what do the professional organizations say about this? Second, the book looks at informed consent as a theoretical matter. It addresses such questions as: What would be the elements of a robust informed consent in psychoanalysis? Is informed consent even possible here? Can patients really understand, say, transference or regression before they experience them, and is it too late once they have? Is informed consent therapeutic or countertherapeutic? Can a “process view” of informed consent make sense here? Third, the book reviews data on the topic. A lengthy questionnaire answered by sixty-two analysts reveals their practices in this regard. Do they obtain a statement of informed consent from their patients? What do they disclose? Why do they disclose it? Do they think it is possible to obtain informed consent in psychoanalysis at all? Do they think the practice is therapeutic or countertherapeutic, and in what ways? Do they think there should or should not be an informed consent requirement for psychoanalysis? The book should appeal above all to therapists interested in the ethical dimensions of their practice.