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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 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.
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 - as an ethical ideal and legal doctrine - has been the source of much concern to clinicians. Drawing on a diverse set of backgrounds and two decades of research in clinical settings, the authors - a lawyer, a physician, a social scientist, and a philosopher - help clinicians understand and cope with their legal obligations and show how the proper handling of informed consent can improve , rather than impede, patient care. Following a concise review of the ethical and legal foundations of informed consent, they provide detailed, practical suggestions for incorporating informed consent into clinical practice. This completely revised and updated edition discusses how to handle informed consent in all phases of the doctor-patient relationship, use of consent forms, patients' refusals of treatment, and consent to research. It comments on recent laws and national policy, and addresses cutting edge issues, such as fulfilling physician obligations under managed care. This clear and succinct book contains a wealth of information that will not only help clinicians meet the legal requirements of informed consent and understand its ethical underpinnings, but also enhance their ability to deal with their patients more effectively. It will be of value to all those working in areas where issues of informed consent are likely to arise, including medicine, biomedical research, mental health care, nursing, dentistry, biomedical ethics, and law.
In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.
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
Consent is a basic component of the ethics of human relations, making permissible a wide range of conduct that would otherwise be wrongful. Consent marks the difference between slavery and employment, permissible sexual relations and rape, borrowing or selling and theft, medical treatment and battery, participation in research and being a human guinea pig. This book assembles the contributions of a distinguished group of scholars concerning the ethics of consent in theory and practice. Part One addresses theoretical perspectives on the nature and moral force of consent, and its relationship to key ethical concepts, such as autonomy and paternalism. Part Two examines consent in a broad range of contexts, including sexual relations, contracts, selling organs, political legitimacy, medicine, and research.
Alasdair Maclean analyses the ethical basis for consent to medical treatment, providing both an extensive reconsideration of the ethical issues and a detailed examination of English law. Importantly, the analysis is given a context by situating consent at the centre of the healthcare professional-patient relationship. This allows the development of a relational model that balances the agency of the two parties with their obligations that arise from that relationship. That relational model is then used to critique the current legal regulation of consent. To conclude, Alasdair Maclean considers the future development of the law and contrasts the model of relational consent with Neil Manson and Onora O'Neill's recent proposal for a model of genuine consent.
The MacArthur Competence Assessment Tool for Treatment (MacCAT-T) is the product of an 8-year study of patients' capacities to make treatment decisions. It is a semi-structured interview that assists clinicians in assessing a patient's competence to consent to treatment. The process provides a patient with information about their medical/psychiatric condition, the type of treatment being recommended, its risks and benefits, as well as other possible treatments and their probable consequences. During this process, the MacCAT-T prompts the clinician to ask questions that assess the patient's understanding, appreciation, and reasoning regarding treatment decisions.The MacCAT-T Manual is a large-format, examiner-friendly field manual for conducting actual competency assessments. The MacCAT-T Record Form is well designed for recording, rating, and summarizing patient responses. The training videotape, Administering the MacCAT-T, demonstrates an actual administration of the test with discussion, comments, and annotations by Drs. Grisso and Appelbaum.The book, Assessing Competence to Consent to Treatment, describes the place of competence in the doctrine of informed consent, analyzes the elements of decision making, and shows how assessments of competence to consent to treatment can be conducted within varied general medical and psychiatric treatment settings. Includes numerous case studies.