Excessive Risk Disclosure: The Effects of the Law on Medical Practice

2005 ◽  
Vol 7 (2) ◽  
pp. 93-112
Author(s):  
Rob Heywood
Keyword(s):  
Informed Consent ◽  
Medical Practice ◽  
Detrimental Effect ◽  
Self Determination ◽  
Consent Process ◽  
Risk Disclosure ◽  
Medical Practitioners ◽  
The Law ◽  
Excessive Risk ◽  
The Way

This article examines the debate surrounding the challenging concept of informed consent. It argues whilst the English courts have effectively excluded the use of the tort of battery as an appropriate mechanism for protecting a patient's right to self-determination, they have left the law in a state of flux due to the uncertainties associated with categorising similar claims within negligence where the onus is on risk disclosure. This confusion may stem firstly from the fact that medical practitioners are unsure exactly which risks to disclose, and secondly, from the way in which both doctors and patients perceive the consent process. The paper suggests this disorder may be having a detrimental effect on medical practice as medical practitioners are taking it upon themselves to disclose excessive information, which patient's may not want or need. A suggestion is also made that in these situations, in order that the law truly respects self-determination, consideration must be given to the patient's desire to waive their right to informed consent. ‘while all are agreed that “doctor knows best” is no longer acceptable, for some “doctor knows better” is just as outdated and paternalistic. The assumption that the doctor's knowledge is deployed to ends that are of benefit to patients is treated with suspicion.’ 1

scholarly journals Adequacy of measures of informed consent in medical practice: A systematic review

PLoS ONE ◽  
2021 ◽  
Vol 16 (5) ◽  
pp. e0251485
Author(s):  
Kerry A. Sherman ◽  
Christopher Jon Kilby ◽  
Melissa Pehlivan ◽  
Brittany Smith
Keyword(s):  
Systematic Review ◽  
Informed Consent ◽  
Medical Practice ◽  
Information Provision ◽  
Self Report ◽  
Consent Process ◽  
Medical Practitioners ◽  
Voluntary Consent ◽  
User Acceptability ◽  
Information Comprehension

As a critical component of medical practice, it is alarming that patient informed consent does not always reflect (1) adequate information provision, (2) comprehension of provided information, and (3) a voluntary decision. Consequences of poor informed consent include low patient satisfaction, compromised treatment adherence, and litigation against medical practitioners. To ensure a well-informed, well-comprehended, and voluntary consent process, the objective and replicable measurement of these domains via psychometrically sound self-report measures is critical. This systematic review aimed to evaluate the adequacy of existing measures in terms of the extent to which they assess the three domains of informed consent, are psychometrically sound and acceptable for use by patients. Extensive searching of multiple databases (PsychINFO, PubMed, Sociological Abstracts, CINAHL, AMED) yielded 10,000 potential studies, with 16 relevant scales identified. No existing scale was found to measure all three consent domains, with most only narrowly assessing aspects of any one domain. Information provision was the most frequently assessed domain, followed by comprehension, and then voluntariness. None of the identified scales were found to have adequate evidence for either high quality psychometric properties or patient user acceptability. No existing scale is fit for purpose in comprehensively assessing all domains of informed consent. In the absence of any existing measure meeting the necessary criteria relating to information, comprehension and voluntariness, there is an urgent need for a new measure of medical consent to be developed that is psychometrically sound, spans all three domains and is acceptable to patients and clinicians alike. These findings provide the impetus and justification for the redesign of the informed consent process, with the aim to provide a robust, reliable and replicable process that will in turn improve the quality of the patient experience and care provided.

Contract as Promise: Lessons Learned

2019 ◽  
Vol 20 (2) ◽  
pp. 367-379
Author(s):  
Charles Fried
Keyword(s):  
Twentieth Century ◽  
Contract Theory ◽  
Choice Theory ◽  
Contract Law ◽  
Lessons Learned ◽  
Self Determination ◽  
Theory Approach ◽  
The Law ◽  
The Way

Abstract In The Choice Theory of Contracts, Hanoch Dagan and Michael Heller state that by arguing “that autonomy matters centrally to contract,” Contract as Promise makes an “enduring contribution . . . but [its] specific arguments faltered because [they] missed the role of diverse contract types and because [it] grounded contractual freedom in a flawed rights-based view. . .. We can now say all rights-based arguments for contractual autonomy have failed.” The authors conclude that their proposed choice theory “approach returns analysis to the mainstream of twentieth-century liberalism – a tradition concerned with enhancing self-determination that is mostly absent in contract theory today.” Perhaps the signal flaw in Contract as Promise they sought to address was the homogenization of all contract types under a single paradigm. In this Article, I defend the promise principle as the appropriate paradigm for the regime of contract law. Along the way I defend the Kantian account of this subject, while acknowledging that state enforcement necessarily introduces elements — both normative and institutional — for which that paradigm fails adequately to account. Of particular interest and validity is Dagan and Heller’s discussion of contract types, to which the law has always and inevitably recurred. They show how this apparent constraint on contractual freedom actually enhances freedom to contract. I discuss what I have learned from their discussion: that choice like languages, is “lumpy,” so that realistically choices must be made between and framed within available types, off the rack, as it were, and not bespoke on each occasion. I do ask as well how these types come into being mutate, and can be deliberately adapted to changing circumstances.

Effectiveness of consenting in Otorhinolaryngology

Open Medicine ◽  
2012 ◽  
Vol 7 (2) ◽  
pp. 198-202
Author(s):  
Nnaemeka Okpala ◽  
Amala Okpala ◽  
Gareth John ◽  
Hugh Cox
Keyword(s):  
Informed Consent ◽  
Therapeutic Alliance ◽  
Medical Practice ◽  
Consent Form ◽  
Consent Process ◽  
Pharyngeal Pouch ◽  
Consent Forms ◽  
Ethical Component ◽  
At Home

AbstractInformed consent in today’s medical practice has become a cornerstone and a routine ethical component playing a major role in forming a therapeutic alliance with the patient. The present study sought to analyse the effectiveness of the consent forms and the consenting process in Otorhinolaryngology. This three month questionnaire-based study covered varying operations which ranged from tonsillectomies, grommet insertions to pharyngeal pouch stapling. Twenty-nine percent of consent forms were signed on the day of the operation. Of the patients who received leaflets (51%) during the process of informed consent, a majority (88%) found it useful. The respondents were satisfied with the explanation of the procedure, benefits and complications (70–74%). Majority kept their consent forms at home (60%) and did not bother engaging in further search with regards to the information in the consent form (81%). Majority of the patients agreed that they had enough time to make an informed consent. Patients were satisfied with the consent process but more can be done to improve the consenting process.

scholarly journals Fears and fallacies: Doctors’ perceptions of the barriers to medical innovation

2019 ◽  
Vol 14 (4) ◽  
pp. 155-164
Author(s):  
Tracey Elliott ◽  
Jose Miola ◽  
Ash Samanta ◽  
Jo Samanta
Keyword(s):  
Cancer Patients ◽  
Medical Practice ◽  
Diagnostic Tests ◽  
Medical Innovation ◽  
Negative Effects ◽  
Medical Specialties ◽  
Medical Practitioners ◽  
Medical Opinion ◽  
The Law ◽  
The Uk

In 2014, Lord Saatchi launched his ultimately unsuccessful Medical Innovation Bill in the UK. Its laudable aim was to free doctors from the shackles that prevented them from providing responsible innovative treatment. Lord Saatchi’s principal contention was that current law was the unsurmountable barrier that prevented clinicians from delivering innovative treatments to cancer patients when conventional options had failed. This was because doctors feared that they might be sued or tried and convicted of gross negligence manslaughter if they deviated from standard practice. Concerns about fear of the law and potential negative effects on medical practice are not new. Fear of litigation has been suggested as the reason for doctors practising “defensive medicine,” by opting for treatments regarded as “grievance-resistant,” rather than clinically indicated, for example, by ordering diagnostic tests or performing certain procedures, which are not strictly medically necessary. Whilst this claim is plausible and apparently accepted by the courts, there is limited empirical evidence in support of it so far as practitioners in the UK are concerned. In this paper, we report on our empirical research which provides a snapshot of medical opinion to begin to rectify this gap. We ran focus groups of different medical specialties, asking what these medical practitioners thought the barriers to medical innovation to be. We found that fear of the law was not the principal barrier to be lowered, and that the answer was far more multifaceted.

“There is no evidence to suggest …”: Changing The Way We Judge Information For Disclosure in the Informed Consent Process

Hypatia ◽  
1997 ◽  
Vol 12 (2) ◽  
pp. 165-184
Author(s):  
Leslie Cannold
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Informed Consent Process ◽  
Consent Process ◽  
Central Importance ◽  
Medical Researchers ◽  
Patient Participant ◽  
The Way

Feminist health activists and medical researchers frequently disagree on the adequacy of the informed consent processes in clinical trials. I argue for an informed consent process that reflects the central importance of patient-participant autonomy. Such a standard may raise concerns for medical researchers about their capacity to control the quantity and quality of the information they disclose to potential participants. These difficulties might be addressed by presenting potential participants with differently sized disclosure packages.

scholarly journals Rethinking Informed Consent: The Case for Shared Medical Decision-Making

2006 ◽  
Vol 32 (4) ◽  
pp. 429-501 ◽  
Author(s):  
Jaime Staples King ◽  
Benjamin W. Moulton
Keyword(s):  
Informed Consent ◽  
Health Services Research ◽  
Health Services ◽  
Medical Practice ◽  
Medical Decision ◽  
Biomedical Science ◽  
Legislative Process ◽  
Services Research ◽  
Legal Standards ◽  
The Law

In law, with rare exception such as legislative action, change is evolutionary and methodical. Unlike biomedical science where a breakthrough can quickly lead to dramatic changes in medical practice, legal precedent is more adherent and must evolve either through the legislative process or on a court by court basis in case law. Nevertheless, compelling evidence will pave the road to change within the law. Health care research conducted over the last three decades has produced a body of empirical evidence that suggests an overhaul of our current legal standards of informed consent is overdue.This article uses health services research to examine the fundamental assumptions of our current informed consent laws and propose legal reform. Much has been written on how to bring the law to bear on medical practice in order to improve patient rights and protect physicians, but far less has been done to bring the practice of medicine to inform our legal standards. Prior legal scholarship on informed consent has made arguments regarding reform from both ethical and legal perspectives; however, only a small few have incorporated clinical and health services research as well as ethical and legal principles to analyze informed consent.

Privileging the medical norm: liberalism, self-determination and refusal of treatment

Legal Studies ◽  
1996 ◽  
Vol 16 (3) ◽  
pp. 348-367 ◽  
Author(s):  
John A Harrington
Keyword(s):  
Informed Consent ◽  
Medical Treatment ◽  
Medical Profession ◽  
Self Determination ◽  
Medical Law ◽  
Refusal Of Treatment ◽  
Medical Context ◽  
Legal Thinking ◽  
The Law

In the last twenty-five years consent has emerged as central to ethical and legal thinking on medical treatment. The meaning of consent and its importance and applicability in the medical context has been tested by scholars and judges in most western jurisdictions. This essay seeks to re-examine the role of consent in medical law in England having regard to a recent series of cases concerning the refusal of treatment. By linking the law, as it has emerged from these decisions, with that developed in the 1980s concerning the doctrine of informed consent it should be possible to draw some conclusions regarding the role of law and the courts in medicine. Throughout we shall be contrasting the supposedly traditional and outdated paternalism of the medical profession with the liberal, pro-autonomy strategies of (mainly) academic commentators.

The doctrine of informed consent: does it exist and has it crossed the Atlantic?

Legal Studies ◽  
2004 ◽  
Vol 24 (3) ◽  
pp. 386-413 ◽  
Author(s):  
Alasdair R Maclean
Keyword(s):  
Informed Consent ◽  
Medical Law ◽  
Legal Concept ◽  
England And Wales ◽  
Us States ◽  
Legal Context ◽  
The Law ◽  
The Way

Use of the term ‘informed consent’ is commonplace in both bioethics and medical law. In the legal context the term may be referred to as ‘the doctrine of informed consent’ but the way that this latter term is used raises doubt as to its value as a legal concept. In this paper I explore the concept of the ‘doctrine of informed consent’ and suggest that it may be useful, but only if limited to the autonomy-driven duty to disclose rather than as a more general referent. Having established the nature of the concept I then consider whether the doctrine - which is applied in a minority of US states, Canada and Australia - has crossed the Atlantic and become part of the law in England and Wales. In particular, I analyse Lord Woolf MR's judgment in Pearce v United Bristol Healthcare NHS Trust and suggest that the law has moved towards the doctrine but that it still falls short of the disclosure required by the reasonable patient standard.

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