Informed consent in clinical practice and literature overview. This book, written from the combined perspectives of a physician, a lawyer, and a social scientist, is the first reference work to provide a concise overview of informed consent with particular emphasis on the practical issues facing professionals. Reforming medical education, monitoring the process of informed consent in clinical settings and redesigning medical institutional arrangements are pathways to restoring the practice of informed. Informed consent in clinical practice society for the.
A primer for clinical practice ebook, you should follow the hyperlink under and save the file or have access to additional information that are have conjunction with informed consent. Legal theory and clinical practice, second edition find, read and cite all the research you need on researchgate. Details publication date 1984 periodical science volume 226 page 960 author of publication paul applebaum, charles w. Few issues affecting the therapeutic professions are as much discussed and as little understood as informed consent. Is there a difference between informed consent in clinical. Informed consent is primarily a legal and ethical concept. The term informed consent first appeared in 1957, and serious discussion of the concept began only around 1972.
Treatment informed consent aims to preserve the autonomy of patients in the clinician patient relationship so as to ensure valid consent. Guidance for irbs, clinical investigators, and sponsors. Enduring and emerging challenges of informed consent. Free and informed consent is required for medical treatments and procedures, except in an emergency situation when informed consent cannot be obtained and there is no indication that a. Mar 20, 2012 although informed consent for clinical treatment has become a vital part of contemporary medical practice, it means different things in different contexts figure 1, is variably practised and rarely achieves the theoretical ideal.
Jul 12, 2001 informed consent as an ethical ideal and legal doctrine has been the source of much concern to clinicians. Informed consent is not an ancient concept with a rich medical tradition. Informed consent is an ethical concept that has become integral to contemporary medical ethics and medical practice. The case for shared medical decisionmaking jaime staples king and benjamin moulton i. Proper documentation and counseling of patients is important in any informed consent. Informed consent is the process of informing a client, patient, or research subject of the risks, benefits, expected outcome of a research project, medication, medical procedure, or therapeutic. Obtaining a patients informed consent to treatment is an expected component of clinical interactions. Informed consent in decisionmaking in pediatric practice. Drawing on a diverse set of backgrounds and two decades of research in clinical settings. The legal theory behind informed consent laws, it seems, differs considerably from the reality of medical practice. In professional and legal regulations it is widely established that informed consent is a necessary element of good clinical practice. Legal scholars have pointed out that the salgo decision.
Conclusions this study suggests that information about treatment theories and protocols. The code of ethics american nurses association, 2010, contextualizes the nurses call to advocacy within the doctrine of informed consent. Conscious patients in emergency situations the basic points with which all clinicians must be familiar are that. Part 1, an introduction to informed consent, contains two chapters that frame the questions underlying informed consent and discuss its ethical justification. Legal theory and clinical practice, by paul applebaum, charles w. Therefore, we sought to synthesize the available knowledge on this subject. It was developed to provide a broad audience within and outside of va with a clear definition of informed consent and the regulations that govern it, as well as the roles and responsibilities of. This document is read and signed before the client begins therapy, so it can set the tone. Fenn journal of the american academy of psychiatry and the law online march 1990, 18 1 108. Informed consent is one pillar of modern clinical practice core. It implies that your health care provider has given you information about your condition and treatment options and that you have used this information to.
Four theoretical ethical perspectives on professionalpatient relationshipsautonomy, justice, virtue ethics, and the ethic of careare surveyed, and some of their implications for the informed consent requirement in health care are sketched out. Patientcentered informed consent in surgical practice. As the idea of informed consent evolved, discussion of appropriate guidelines moved increasingly from a narrow. It is not merely a form that is signed but is a process, in which the subject has an understanding of the research and its risks. Basically, informed consent means that sufficient information is provided to. Informed consent legal theory and clinical practice ebook pdf book jan 21, 2020. The notion that a person as an autonomous being has a right to decide whether or not to consent to medical treatment from an informed basis has its origins in both law and ethical theory. The support for informed consent in ethical theory is most commonly found in the concept of autonomy. Professionalpatient relationships and informed consent.
When concerns are not satisfactorily addressed from the patients. Informed consent it has long been part of south african law that a patient must provide informed consent for all medical treatment diagnostic or therapeutic on himher stoffberg v elliot, 1912. While the form is a legal document, informed consent should also be inviting, reassuring, and easily understood. 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. A person signs a legal release form for a medical procedure, and later feels. Request pdf on apr 1, 2002, john petrila and others published informed consent. A health care provider may ask a patient to consent to receive therapy before providing it, or a clinical researcher may. Although informed consent for clinical treatment has become a vital part of contemporary medical practice, it means different things in different contexts, is variably practised and rarely achieves the theoretical ideal. However, it is important to recognize that informed consent extends beyond the provision of information on how and when client information will be disclosed or shared. It has wide ramification and different interpretations in the present healthcare system. Written consent is not a mandatory legal requirement. This guidance document is being distributed for comment purposes only. It was developed to provide a broad audience within and.
Medical practice today is not simple because of various factors impinging on. This article the first in a twopart series explores the legal principles of informed consent in adults, considers why it is fundamental to the provision of personcentred care, and explains how the law relating to informed consent has recently changed. Legal theory and clinical practice, edition 2 ebook written by jessica w. Informed consent is a widely accepted legal, ethical, and regula. The legal concept of informed consent has its roots in case law addressing issues of battery and medical. The consensus about the importance of informed consent for acceptable clinical practice does not sit well with a wealth of recent research findings about the problems of communicating relevant information to patients. The theory behind informed consent presumes that patients will use the. Informed consent is an established ethical and legal requirement for surgical treatment. Informed consent legal theory and clinical practice.
This article offers a primer on the legal, ethical, and practical aspects of procedural informed consent and examines the value of nursings role within the process. Informed consent is a process for getting permission before conducting a healthcare intervention on a person, or for disclosing personal information. A health care provider may ask a patient to consent to receive therapy before providing it, or a clinical researcher may ask a research participant before enrolling that person into a clinical trial. Informed consent is a voluntary agreement to participate in research. Do not forget that clients entering counseling for the first time are usually anxious and do not know what to expect. The book will be valuable for all professionals working in areas where issues of informed consent are likely to arise, including medicine, mental health care, social work, dentistry and law. Informed consent is essential before enrolling a participant and ongoing once enrolled. Effective informed consent embodies the shift in primary care medicine to guide rather than dictate an individuals health care decisions, often termed shared. An essential part of the ethical practice of medicine, 1 it is also an opportunity to strengthen the doctorpatient relationship. Informed consent for clinical treatment in lowincome setting. May 21, 2018 this article the first in a series of two discusses why informed consent is fundamental to the provision of personcentred care and explores the legal principles behind it.
It may be easy to view informed consent as one of those obligations all psychotherapists must meet in order to stay out of trouble. It has important roots in angloamerican political theory and has been articulated in the law in a series of judicial decisions. Legal theory and clinical practice informed consent as an ethical ideal and. Informed consent is a manifestation of the ethical principle of respect for autonomy, where an individual has the right to all of the pertinent information regarding participation in a research study, and may make the sole decision about whether or not to participate in that study. 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. Resources on informed consent in psychotherapy and counseling, part of an online course for ce credits ceus for psychologists, social workers, lcsws, mfts, counselors and nurses. For too long, informed consent in clinical practice has been influenced by an interpretation of informed decision making as a legal obligation in which the emphasis is full disclosure, rather than an ethical obligation toward mutual decision making by fostering understanding. Introduction in law, with rare exception such as legislative action, change is evolutionary and methodical. An acceptable method of evaluating understanding of consent information is by assessing the extent of recall by patients of the pieces information believed to have been passed across. Informed consent procedures with cognitively impaired patients. In recognition of the ethical importance of informed consent, the committee on ethics of the american college of obstetricians and gynecologists acog affirms the following eight statements.
Although informed consent has both legal and ethical implications, its purpose is. Informed consent as an ethical and legal doctrine has been the source of much concern to physicians. Read informed consent legal theory and clinical practice. Once viewed as simply a legal preamble to treatment, informed consent today encompasses much more.
Informed consent is a legal requirement to be fulfilled before any procedure is carried out in clinical practice. Critical approaches to the law of informed consent part iii. Informed consent as an ethical ideal and legal doctrine has been the source of much concern to clinicians. The journal of legal medicine, volume 9, number i, 1988. Lack of standardized informed consent practices and medical. Nonetheless, the practice of informed consent varies by context, and the reality often falls short of the theoretical ideal. Background informed consent is a mainstay of clinical practice, with both moral and legal. Enduring and emerging challenges of informed consent idcrp. This is a precopyedited, authorproduced pdf of an article accepted for. This primer is an outgrowth of the informed consent sota conference.
A consent form is a legal document that ensures an ongoing communication process between you and your health care provider. Indeed, the very first principle of the nuremberg code1, which represents the genesis. Oct 01, 2015 although the need to obtain informed consent is well understood in clinical and research environments, the evidence suggests that patients, family members, and participants in research are often unclear about options, risks, and benefits even after providing informed consent. Clinical experience as well as developments in ethical theory generated further questions about the practice of informed consent and the legal doctrine that promoted it. Unlike biomedical science where a breakthrough can quickly lead to dramatic changes in medical practice. Lucid and thoughtful discussion of informed consent and the doctorpatient relationship. Informed consent in clinical practice and literature. Informed consent procedures with cognitively impaired. After all, no one wants an ethics complaint, licensure board complaint, or malpractice suit. Informed consent in clinical and research settings. And, if we ever do become the subject of any of these we will definitely want to have met our informed consent obligations to our clients in an exemplary manner. 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. The first page of the pdf of this article appears above. Consent is needed for all clinical examinations, investigations and treatment.
Informed consent resources for psychologists, mfts. Physician practices that participate in ascos quality oncology practice initiative qopi and others expressed interest in having asco provide informed consent resources, and indicated that they would be more likely to use a consent form for chemotherapy if asco provided a template. Every investigator and clinical research coordinator crc should recognize the importance of obtaining valid and appropriate informed consent as an important protection of the rights and welfare of human subjects. Purpose of informed consent the current concept of informed consent in medical practice has roots within both ethical theory and law. Although informed consent for clinical treatment has become a vital part of contemporary medical practice, it means different things in different contexts figure 1, is variably practised and rarely achieves the theoretical ideal. Journal of the american academy of psychiatry and the law online. Informed consent is a vital document while performing all surgical and aesthetic procedures, particularly in the current day practice. A primer for clinical practice to save informed consent. Contemporary developments in health care and clinical.
1204 1434 746 821 404 1130 480 684 793 671 927 744 60 1117 437 788 326 709 674 315 342 627 557 51 1364 1108 1403 254 577 992