Informed consent as an ethical and legal doctrine has been the source of much concern to physicians. The term informed consent first appeared in 1957, and serious discussion of the concept began only around 1972. 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. It has important roots in angloamerican political theory and has been articulated in the law in a series of judicial decisions. Nonetheless, the practice of informed consent varies by context, and the reality often falls short of the theoretical ideal.
In professional and legal regulations it is widely established that informed consent is a necessary element of good clinical practice. A consent form is a legal document that ensures an ongoing communication process between you and your health care provider. It has wide ramification and different interpretations in the present healthcare system. 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. After all, no one wants an ethics complaint, licensure board complaint, or malpractice suit.
The legal concept of informed consent has its roots in case law addressing issues of battery and medical. 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. Informed consent in clinical practice and literature. Attending to the variability of informed consent because these variations in health care delivery standards make it difficult to assess conformity with informed consent laws, scholars have proposed solutions that would establish. Journal of the american academy of psychiatry and the law online. Informed consent for clinical treatment in lowincome setting. Few issues affecting the therapeutic professions are as much discussed and as little understood as informed consent. 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.
Informed consent is essential before enrolling a participant and ongoing once enrolled. The first page of the pdf of this article appears above. Informed consent procedures with cognitively impaired patients. Lack of standardized informed consent practices and medical. This is a precopyedited, authorproduced pdf of an article accepted for. Purpose of informed consent the current concept of informed consent in medical practice has roots within both ethical theory and law. Contemporary developments in health care and clinical. Informed consent in clinical practice society for the. Request pdf on apr 1, 2002, john petrila and others published informed consent. Read informed consent legal theory and clinical practice. Critical approaches to the law of informed consent part iii. 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.
A person signs a legal release form for a medical procedure, and later feels. Consent is needed for all clinical examinations, investigations and treatment. The legal theory behind informed consent laws, it seems, differs considerably from the reality of medical practice. 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. Informed consent resources for psychologists, mfts. 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 in clinical and research settings. Guidance for irbs, clinical investigators, and sponsors. 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. Informed consent is a process for getting permission before conducting a healthcare intervention on a person, or for disclosing personal information. Is there a difference between informed consent in clinical. Introduction informed consent is the cornerstone of clinical practice and is evidence that a clear, concise and structured explanation was given prior to a procedure. Informed consent in decisionmaking in pediatric practice. 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.
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. Drawing on a diverse set of backgrounds and two decades of research in clinical settings. Legal theory and clinical practice is divided into five parts comprising fifteen chapters. 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. Legal scholars have pointed out that the salgo decision. Therefore, we sought to synthesize the available knowledge on this subject. Although informed consent has both legal and ethical implications, its purpose is. The code of ethics american nurses association, 2010, contextualizes the nurses call to advocacy within the doctrine of informed consent. Informed consent legal theory and clinical practice ebook pdf book jan 21, 2020. Informed consent is a widely accepted legal, ethical, and regula. 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. The journal of legal medicine, volume 9, number i, 1988. A primer for clinical practice to save informed consent. Obtaining a patients informed consent to treatment is an expected component of clinical interactions.
The theory behind informed consent presumes that patients will use the. Professionalpatient relationships and informed consent. Informed consent is a legal requirement to be fulfilled before any procedure is carried out in clinical practice. This document is read and signed before the client begins therapy, so it can set the tone. This guidance document is being distributed for comment purposes only. Informed consent is primarily a legal and ethical concept. It may be easy to view informed consent as one of those obligations all psychotherapists must meet in order to stay out of trouble. Informed consent is not an ancient concept with a rich medical tradition. 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. 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. Conscious patients in emergency situations the basic points with which all clinicians must be familiar are that. Once viewed as simply a legal preamble to treatment, informed consent today encompasses much more. 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.
Basically, informed consent means that sufficient information is provided to. 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. 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. Background informed consent is a mainstay of clinical practice, with both moral and legal. Indeed, the very first principle of the nuremberg code1, which represents the genesis. Lucid and thoughtful discussion of informed consent and the doctorpatient relationship.
Legal theory and clinical practice, by paul applebaum, charles w. Informed consent is a vital document while performing all surgical and aesthetic procedures, particularly in the current day practice. Medical practice today is not simple because of various factors impinging on. Informed consent as an ethical ideal and legal doctrine has been the source of much concern to clinicians. 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. Based on my analysis of both ethical theory and clinical practice, i make recommendations about the ways to increase the coherence between the ideals within ethical theories of autonomy and the. When concerns are not satisfactorily addressed from the patients. 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. Unlike biomedical science where a breakthrough can quickly lead to dramatic changes in medical practice. 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.
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. 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. This primer is an outgrowth of the informed consent sota conference. The support for informed consent in ethical theory is most commonly found in the concept of autonomy. An essential part of the ethical practice of medicine, 1 it is also an opportunity to strengthen the doctorpatient relationship. Enduring and emerging challenges of informed consent idcrp. 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. Legal theory and clinical practice, second edition find, read and cite all the research you need on researchgate. 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. 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.
Proper documentation and counseling of patients is important in any informed consent. Informed consent is a voluntary agreement to participate in research. Conclusions this study suggests that information about treatment theories and protocols. Written consent is not a mandatory legal requirement. Informed consent legal theory and clinical practice jessica w berg paul s appelbaum lisa s parker charles w lidz on amazoncom free shipping on qualifying o. 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. 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. 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. Introduction in law, with rare exception such as legislative action, change is evolutionary and methodical. Part 1, an introduction to informed consent, contains two chapters that frame the questions underlying informed consent and discuss its ethical justification. Informed consent is an ethical concept that has become integral to contemporary medical ethics and medical practice. Legal theory and clinical practice informed consent as an ethical ideal and. 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.
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. It was developed to provide a broad audience within and. Jul 12, 2001 informed consent as an ethical ideal and legal doctrine has been the source of much concern to clinicians. Do not forget that clients entering counseling for the first time are usually anxious and do not know what to expect. Informed consent legal theory and clinical practice. Effective informed consent embodies the shift in primary care medicine to guide rather than dictate an individuals health care decisions, often termed shared. Treatment informed consent aims to preserve the autonomy of patients in the clinician patient relationship so as to ensure valid consent.
Legal theory and clinical practice, edition 2 ebook written by jessica w. Patientcentered informed consent in surgical practice. Consent to treatment is an important part of the delivery of quality cancer care. 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. 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. Informed consent is an established ethical and legal requirement for surgical treatment. 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. As the idea of informed consent evolved, discussion of appropriate guidelines moved increasingly from a narrow. Informed consent procedures with cognitively impaired. 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. Enduring and emerging challenges of informed consent. The case for shared medical decisionmaking jaime staples king and benjamin moulton i.
579 481 441 1487 32 265 284 1503 183 1331 1033 431 604 1443 547 1342 1317 1621 640 1469 1463 1554 738 377 1109 236 457 1219 663 315 1264 336 476