Informed Consent: Framing the Questions

Author(s):  
Jessica W. Berg ◽  
Paul S. Appelbaum ◽  
Charles W. Lidz ◽  
Lisa S. Parker

What is informed consent? The answer may seem self-evident only to those who have yet to explore the many meanings of the term. Informed consent refers to legal rules that prescribe behaviors for physicians and other healthcare professionals in their interactions with patients and provide for penalties, under given circumstances, if physicians deviate from those expectations; to an ethical doctrine, rooted in our society’s cherished value of autonomy, that promotes patients’ right of self-determination regarding medical treatment; and to an interpersonal process whereby these parties interact with each other to select an appropriate course of medical care. Informed consent is each of these things, yet none of them alone. As a theory based on ethical principles, given effect by legal rulings and implemented by clinicians, it has been haunted by its complex lineage. When legal principles and ethical values conflict, which should take precedence? When clinical interests appear to be served by neither legal nor ethical concerns, which interests should be compromised and to what degree? The vast literature on informed consent, found in journals and books of medicine, law, bioethics, philosophy, and public policy, has been stimulated by the need to create a workable doctrine that can accommodate values that to many observers are in an irremediable state of conflict. The conflicts in theory and the need to resolve them in practice are the subjects of this book. Theory is the focus of the first half of the volume; practice is the topic of the second. Seeking to understand the fascinating theoretical problems requires us to grapple with some of the most difficult ethical and policy issues facing our society today. But let us state at the outset our belief that the clinician on the front lines need not be paralyzed by differences of opinion among legal and ethical theorists. Through the vaguely translucent wall of expertise behind which the discussion about the proper shape of the informed consent doctrine has taken place, a reasonable approach to informed consent in the clinician-patient relationship can be discerned. Our most important and challenging task in this book is to make that approach evident.

2019 ◽  
Vol 32 (1) ◽  
pp. 53
Author(s):  
Luís Guilherme Casimiro ◽  
Sara Marisa Pereira ◽  
Sofia Cardoso Pires ◽  
Joana Mourão

Introduction: Informed consent is an active process of the doctor-patient relationship, based on ethical and legal principles. The anesthetic act has inherent risks, which should be subject of specific consent. The aim of this study was to evaluate the degree of implementation of written specific informed consent for anesthesia in the context of elective surgery.Material and Methods: An observational prospective study, at a tertiary university hospital, in 230 patients aged 60 years or older, undergoing elective surgery between May and July 2017. Eligible patients who consented to participate were interviewed clinically on the day before surgery. In the postoperative period, the anesthetic technique and the existence of the written informed consent for the anesthetic and surgical procedures were assessed. Patients who were unable to give informed consent or those admitted in the Intensive Care Unit after surgery were excluded. Results: Written informed consent for the surgical procedure was obtained for 225 (97.8%), while it was obtained in just 96 (41.7%) patients for the anesthetic act. There was a higher prevalence of stroke, anemia, and higher Charlson and physical American Society of Anesthesiologists scores in patients without written informed consent for the anesthetic act.Discussion: We identified a low implementation of written informed consent for anesthesia. This situation may have important implications in the context of disciplinary, civil or criminal liability.Conclusion: Despite its importance, the practice of written informed consent for anesthesia in this institution is not yet implemented on a regular basis.


2021 ◽  
Vol 2 (1) ◽  
pp. 31-39
Author(s):  
Inensa Khoirul Harap

Awareness of risks may be interpreted as a patient's approval in the context of submitting the doctor's schedule with the necessary details for making an appointment or an informed refuse. Prior to signing the consent document, the agreement, the prospective student already confirmed that she understood the terms and conditions. to let the patient understand anything before doing it, and when making the judgment, the patient should make the most of any of an exhaustive information (informed decision). The kinds of studies found in this paper are what lawyers refer to as "normative" studies. The nature of this analysis is informative, and is research that outlines, discusses, illustrates, and analyzes legal rules pertaining to the role of consent in the doctor and patient's relationship. Patients are given the right to know regarding the medical activities, outlined in Regulation Minister of Health (Per) No. 290 on Approval of Medical Actions, prior to accessing treatment. As seen from the standpoint of the idea of unauthorized consent (considered given), the patient-doctor partnership becomes complicated. This issue revolves around the concept of informed consent, which is essentially an assumption that the patient has already agreed to carry out medical procedures with the doctor prior to seeking medical treatment.


1987 ◽  
Vol 12 (1) ◽  
pp. 55-97 ◽  
Author(s):  
Fran Carnerie

AbstractMany individuals develop a temporary state of cognitive and emotional impairment after being diagnosed with catastrophic illness. Thus, when crucial decisions about medical treatment are required, they are unable to assimilate information; or worse, the legal need to be informed can rival a psychological desire to not be informed. The Canadian informed consent doctrine is unresponsive to crisis and clinically impracticable, and so paradoxically compromises the integrity and autonomy it was designed to protect. Many aspects of the physician-patient relationship and clinical setting also undermine the philosophical values enshrined in this doctrine. This further jeopardizes the individual's integrity. The Article explores proposals for change such as delaying the informing and consenting, improving the concept of consent, and improving the role of the physician.


2018 ◽  
Vol 38 (05) ◽  
pp. 539-547 ◽  
Author(s):  
Neil Vaishnav ◽  
Winston Chiong

AbstractThe doctrine of informed consent sits at the intersection of law, ethics, and neuroscience, posing unique challenges for human subject research involving neurological patients. These challenges are compounded by the variegated nature of both neurological injury and the law governing research consent. This article provides a framework for investigators likely to encounter subjects with some degree of neurological impairment, whose capacity to consent requires scrupulous assessment prior to enrollment in research trials. We consider several researches and disease contexts—from emergency epilepsy research to long-term dementia research—and clarify the ethical and legal principles governing consent for participation in each. We additionally explore empirical research on consent capacity and survey several areas of emerging ethical import that will require the attention of investigators in decades to come.


Author(s):  
Brian Lee Jones

This chapter presents the unique case of deviantART.com – a popular social networking and image-sharing platform for artists. The chapter introduces and describes the platform, its history, and some of the features the platform offers. It forwards a brief summation of current research, outlines issues emerging from that research, explores the strength and weaknesses of that research, and discusses some of the many difficulties related to researching the platform and its members. The chapter includes a discussion of “creativity” and the economically centric rhetoric and misconceptions latent in hyped popular discourse surrounding the rise of a “creative economy.” A discussion of educational issues from an art education perspective is also included in the chapter, which concludes with a presentation of larger social and policy issues related to deviantART.com.


Author(s):  
Jessica W. Berg ◽  
Paul S. Appelbaum ◽  
Charles W. Lidz ◽  
Lisa S. Parker

This chapter deals with the legal theory and procedural framework under which patients can obtain redress for their injuries resulting from treatment administered in the absence of informed consent. The evolution of the legal doctrine was driven by the demands of patients for redress for injuries, and more attention has been given by courts and legislatures to the questions of when and how compensation might be obtained than to providing guidance for clinicians. In some important respects, the distinction between the law as it applies to the physician engaged in medical decision making with a patient and the law as it applies to that same patient who later seeks compensation in the courts is an artificial one. Insofar as the spirit of informed consent is not embraced voluntarily by the medical profession, but is adhered to in large part to avoid the likely consequences of failure to observe the legal rules, physician behavior will be shaped not only by the rules themselves but also by the way they are enforced. If, for example, the rules governing the means of redress were complex, time-consuming, and unlikely to yield the desired compensation, few injured patients would pursue a judicial remedy. As a result, physicians would eventually realize that adverse consequences were unlikely to follow from a failure to observe the relevant rules and, except to the extent that they had accepted the ethical theory of informed consent, their adherence to the doctrine would crumble. Some critics of the present system contend that this has already happened (see Chapter 7). On the other hand, rules that make recovery easier and more certain would be likely to encourage compliance with the requirements for informed consent. Differential emphasis by the courts on particular kinds of lapses by clinicians might also shape their actions accordingly. For example, the courts’ focus on risk information has led many physicians to tailor disclosure to emphasize risks. Thus, the issues addressed in this chapter, although framed in legal terminology, are important (some would argue crucial) determinants of the ultimate impact of informed consent.


2018 ◽  
Vol 94 (1113) ◽  
pp. 411-414
Author(s):  
Zachary R Paterick ◽  
Nachiket J Patel ◽  
Timothy Edward Paterick

On-call physicians encounter a diverse aggregate of interfaces with sundry persons concerning patient care that may surface potential legal peril. The duties and obligations of an on-call physician, who must act as a fiduciary to all patients, create a myriad of circumstances where there is a risk of falling prey to legal ambiguities. The understanding of the doctor–patient relationship, the obligations of physicians under the Emergency Medical Treatment and Labor Act, the meaning of medical informed consent and the elements of negligence will help physicians avoid the legal risk associated with the various encounters of being on call. After introducing the legal concepts, we will explore the interactions that may put physicians at legal risk and outline how to mitigate that risk. Being on call is time consuming and arduous. While on call, physicians have a duty to act morally and ethically in the best interest of the patients.


Author(s):  
C. H. Alexandrowicz

This chapter examines some of the legal problems resulting from the entry of the ‘new’ states (mainly the Afro–Asian countries) into the family of nations. The orthodox view is that such states have no choice as to the law which shall apply to them since they are born into the existing international order and must accept its tenets. However, the practice of the ‘new’ states does not supply sufficient evidence of such a fait accompli. There are legal rules that they tend to reject as well as rules they wish to have included. Among the existing principles that ‘new’ states refuse to accept or that they accepted with far-reaching reservations are the legal principles relating to economic relations. Other branches of international law that are under revisionist pressure from the ‘new’ states are the law of state succession and the law of the sea.


2020 ◽  
Vol 15 (2) ◽  
Author(s):  
Shady Nashaat Garas ◽  
Luke Witherspoon ◽  
Nikolija Lukich ◽  
Hamid Abdi ◽  
Rodney H. Breau

2020 ◽  
Vol 20 (3) ◽  
pp. 256-283
Author(s):  
Himani Bhakuni

There is a well-established common law doctrine for ascertaining information disclosure in informed consent claims within the treatment context that governs the doctor–patient relationship. But there is no such doctrine in clinical research governing the researcher–participant relationship in India. India, however, is not exceptional in this regard. Common law countries like the United States and Canada at most have sparse, non-systematised, criteria for such cases; arguably, a doctrine for research is at its nascent stage. But the adequacy of the existing criteria for settling informed consent claims in research has hardly ever been discussed. Furthermore, a specific discussion on the applicability of this ‘nascent doctrine’ to India is non-existent. This article discusses both. The article examines case law from India and other common law jurisdictions that hint at developments in this area. It suggests that Indian courts need to move abreast with other jurisdictions to better protect India’s patients and research participants.


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