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A New Paradigm for Informed Consent

A New Paradigm for Informed Consent PDF Author: Irene S. Switankowsky
Publisher: University Press of America
ISBN: 9780761810162
Category : Law
Languages : en
Pages : 164

Book Description
Presents a new paradigm for informed consent based on autonomous, reflective, rational, substantially understood medical treatments that are substantially disclosed to the patient. The author redefines the physician-patient relationship as an equal partnership between two individuals with the common goal of improving overall health and well-being. She argues that if this view is acknowledged and practiced by the medical community, it will lesson the burdens of achieving an effective informed consent which is based on an autonomously derived decision by the patient. Annotation copyrighted by Book News, Inc., Portland, OR

A New Paradigm for Informed Consent

A New Paradigm for Informed Consent PDF Author: Irene S. Switankowsky
Publisher: University Press of America
ISBN: 9780761810162
Category : Law
Languages : en
Pages : 164

Book Description
Presents a new paradigm for informed consent based on autonomous, reflective, rational, substantially understood medical treatments that are substantially disclosed to the patient. The author redefines the physician-patient relationship as an equal partnership between two individuals with the common goal of improving overall health and well-being. She argues that if this view is acknowledged and practiced by the medical community, it will lesson the burdens of achieving an effective informed consent which is based on an autonomously derived decision by the patient. Annotation copyrighted by Book News, Inc., Portland, OR

Informed Consent and Health Literacy

Informed Consent and Health Literacy PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309317304
Category : Medical
Languages : en
Pages : 228

Book Description
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.

Conducting Biosocial Surveys

Conducting Biosocial Surveys PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309157064
Category : Computers
Languages : en
Pages : 124

Book Description
Recent years have seen a growing tendency for social scientists to collect biological specimens such as blood, urine, and saliva as part of large-scale household surveys. By combining biological and social data, scientists are opening up new fields of inquiry and are able for the first time to address many new questions and connections. But including biospecimens in social surveys also adds a great deal of complexity and cost to the investigator's task. Along with the usual concerns about informed consent, privacy issues, and the best ways to collect, store, and share data, researchers now face a variety of issues that are much less familiar or that appear in a new light. In particular, collecting and storing human biological materials for use in social science research raises additional legal, ethical, and social issues, as well as practical issues related to the storage, retrieval, and sharing of data. For example, acquiring biological data and linking them to social science databases requires a more complex informed consent process, the development of a biorepository, the establishment of data sharing policies, and the creation of a process for deciding how the data are going to be shared and used for secondary analysis-all of which add cost to a survey and require additional time and attention from the investigators. These issues also are likely to be unfamiliar to social scientists who have not worked with biological specimens in the past. Adding to the attraction of collecting biospecimens but also to the complexity of sharing and protecting the data is the fact that this is an era of incredibly rapid gains in our understanding of complex biological and physiological phenomena. Thus the tradeoffs between the risks and opportunities of expanding access to research data are constantly changing. Conducting Biosocial Surveys offers findings and recommendations concerning the best approaches to the collection, storage, use, and sharing of biospecimens gathered in social science surveys and the digital representations of biological data derived therefrom. It is aimed at researchers interested in carrying out such surveys, their institutions, and their funding agencies.

Informed Consent

Informed Consent PDF Author: Jessica W. Berg
Publisher: Oxford University Press
ISBN: 0199747784
Category : Medical
Languages : en
Pages : 354

Book Description
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.

Returning Individual Research Results to Participants

Returning Individual Research Results to Participants PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309475201
Category : Medical
Languages : en
Pages : 399

Book Description
When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.

Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes PDF Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385

Book Description
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.

Changing Course

Changing Course PDF Author: Asian Development Bank
Publisher: Asian Development Bank
ISBN: 9292547186
Category : Transportation
Languages : en
Pages : 84

Book Description
Most Asian cities have grown more congested, more sprawling, and less livable in recent years; and statistics suggest that this trend will continue. Rather than mitigate the problems, transport policies have often exacerbated them. In this book, the Asian Development Bank outlines a new paradigm for sustainable urban transport that gives Asian cities a workable, step-by-step blueprint for reversing the trend and moving toward safer, cleaner, more sustainable cities, and a better quality of urban life.

Self-determination in Health Care

Self-determination in Health Care PDF Author: Leroy C. Edozien
Publisher: Routledge
ISBN: 1317057422
Category : Medical
Languages : en
Pages : 293

Book Description
It is generally accepted in legal and bioethical discourse that the patient has a right to self-determination. In practice though, this is often not the case. Paternalism is waning and it is increasingly recognised that there are values other than medical factors which determine the choices that patients make. Unfortunately, these developments have not resulted in huge advances for patient self-determination, which is largely because the consent model has fundamental flaws that constrain its effectiveness. This book sets out to offer an alternative model to consent. In the property model proposed here, the patient’s bodily integrity is protected from unauthorised invasion, and their legitimate expectation to be provided with the relevant information to make an informed decision is taken to be a proprietary right. It is argued that the property model potentially overcomes the limitations of the consent model, including the obstacle caused by the requirement to prove causation in consent cases. The author proposes that this model could in the future provide an alternative or complementary approach for the courts to consider when dealing with cases relating to self-determination in health care.

The Ethics of Consent

The Ethics of Consent PDF Author: Franklin Miller
Publisher: Oxford University Press
ISBN: 019971505X
Category : Medical
Languages : en
Pages : 431

Book Description
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.

Consent in Clinical Practice

Consent in Clinical Practice PDF Author: Margaret Mayberry
Publisher: CRC Press
ISBN: 1315344904
Category : Medical
Languages : en
Pages : 179

Book Description
This is a practical guide to successfully achieving a fully computerised system in primary care. It shows how to source a primary care clinical system that does what you need it to do and how to use it effectively. The book is easy to read with numerous examples and copies of useful documents throughout. Helpful features include charts to map progress at a glance icons to point out www links details of additional resources for further information and highlights cautions and key points are highlighted. The author has drawn together ten years' practical experience working with over 200 practices and incorporates the best national and international expertise. This is an essential guide for GPs practice nurses managers and all members of the primary care team. For downloadable resources accompanying this book click here