Doctrine Of Informed Consent Research Articles

A SYSTEMATIC REVIEW OF PATIENT PERSPECTIVE ON THE INFORMED CONSENT DOCTRINE: ETHICAL AND LEGAL REFLECTIONS

Informed consent is an ethical and legal doctrine of patients’ right of acquiescence to treatment and the disclosure of adequate information by the physician to facilitate patients’ medical decisions. The doctrine seeks to expand the scope of potential legal liabilities of medical practitioners and to promote patients’ rights to medical care. A breach of the informed consent doctrine could be actionable in battery or assault when there is bodily trespass without consent and the tort of clinical negligence when there are inadequate disclosures. This article is a desk-top systematic review of primary data from seven independent empirical studies on informed consent from the perspective of the patient in five common law African countries. The publications which were purposively searched and extracted from Google Scholar reveal that though majority of patients (at least 79 percent) granted consent for treatment, there was insufficient disclosure of material complications or risks, treatment alternatives or the right of patients to refuse medical treatment if they so wished. Disclosures on material risks were as low as 21.2 percent of patients. The physician’s competence in providing adequate information disclosure, demands continual medical training in the practice of the informed consent doctrine. The application of communication strategies that could enhance patients’ capacity to understand the informed consent process is recommended. Additionally, clear guidelines from relevant regulatory bodies are recommended to promote patient rights to informed consent and to protect medical practitioners from potential legal liabilities.

Traditional Health Care Practitioners' Perspectives on Applying Informed Consent During African Traditional Medical Practice in Akwa Ibom State, Nigeria: A Cross-Sectional Qualitative Study.

Introduction: This study explored the perspectives of traditional health care practitioners (THPs) practicing in the areas of herbalism, bone setting, and traditional birth attendance, from Akwa Ibom state, Nigeria, on the possibility and implications of applying informed consent (IC) during African traditional medicine (ATM) practice. Methods: Semistructured interviews were conducted with 11 THPs, consisting of 5 herbalists, 3 traditional bone setters (TBS), and 3 traditional birth attendants (TBAs), who represented the diverse groups that the study intended to cover. In-depth interviews were conducted using a semistructured guide and were recorded, transcribed, and analyzed using thematic analysis with the assistance of NVivo® qualitative analysis software. Results: Participants were seven males (64%) and four females (36%), 35-67 years of age, with 5-25 years of experience as THPs. Forty-six percent of participants were herbalists (27%), TBS, and TBAs (27%). Most participants (82%) were Annang, and (18%) were Ibibio first-language speakers. Three major themes emerged from the data analysis: (i) Existing ethical framework related to IC, (ii) knowledge of consent, and (iii) application of IC during traditional medical practice. These themes and relevant subthemes were explored. All (100%) THPs agreed that it was essential to communicate risks and benefits while allowing patients to ask questions before treatment. All participants (100%) stated that risk communication is essential in ATM, whereas 36% said they communicated all therapy benefits to their patients. Respondents believed patients could make an informed choice if they had complete information disclosure. However, THPs in this study had limited knowledge of formal IC rules and regulations. Conclusions: This study revealed that THPs in this setting disclose a diagnosis, risks, some benefits, and treatment options to patients. Consent/agreement was obtained verbally and voluntarily during ATM practice, consistent with IC doctrine. THPs had limited knowledge of the critical elements of IC. However, they suggested that a form of IC that does not conflict with traditional African norms could be applicable in ATM. IC could facilitate documentation and help reduce risks in ATM practice.

Workshop Proceedings: Informed Consent in Biobanking–from the Key Barriers, Challenges, and Perceptions to Digital Innovations

Workshop Proceedings: Informed Consent in Biobanking–from the Key Barriers, Challenges, and Perceptions to Digital Innovations

The Rise of the French Doctrine of Informed Consent: Criminal Responsibility for an Unauthorised Medical Experiment – The Case of the Antiquaille Hospital and Subsequent Notable Judgments

The French doctrine regarding a patient’s informed consent has a long and very rich history, dating back at least to the mid-nineteenth century. Medical malpractice had become a frequent subject of criminal trials and civil litigation against physicians and surgeons in the nineteenth and early twentieth centuries, resulting in French medical case law and its academic scholarship becoming one of the most prominent throughout all the civil law jurisdictions. Simultaneously, medical malpractice lawsuits were not rare in civil or common law jurisdictions. The uniqueness of French jurisprudence lies in the development of a robust body of case law, which formed the basis for patients’ rights, and specifically informed consent and the right to medical data confidentiality. The right to informed consent is a reflection of the patient’s right to their own bodily integrity, which may not be violated for the purpose of treatment, except in an emergency. Moreover, the rule of consent is even stricter if physicians are administering experimental treatment (which is not generally banned, as it may benefit the patient), or conducting certain methods of treatment for purely scientific purposes – as was in the case of the Antiquaille Hospital in Lyon, where a dangerous and experimental method of treatment was used to treat a ten-year-old minor suffering from dermatophytosis, which was not authorised by his guardians. The case, which was adjudicated by the criminal court of Lyon, is historically one of the first legal cases to deal with unconsented treatment conducted for the purpose of a scientific experiment. Over the twentieth century, similar legal cases became more frequent in France. Keywords: informed consent, medical experiments, patient autonomy, right to bodily integrity, medical law, French law.

Clinical discussion of Medical Aid-in-Dying: minimizing harms and ensuring informed choice

ObjectiveThe implementation of medical aid-in-dying (MAID) poses new challenges for clinical communication and counseling. Among these, health care providers must consider whether to initiate a discussion of MAID with eligible patients who do not directly ask about it. Norms and policies concerning this issue vary tremendously across jurisdictions where MAID is legally authorized, reflecting divergent assumptions about patients’ rights to information about end-of-life options and the purpose and potential harms of clinical disclosure. MethodThis discussion forum essay draws on informed consent doctrine to analyze two policies concerning clinical communication about MAID: the legal prohibition against provider-initiated discussions of MAID in Victoria, Australia, and the Canadian Association of MAID Assessors and Providers (CAMAP) position that providers have an ethical and professional responsibility to inform eligible patients about MAID. ConclusionsInformed consent requires that clinicians strike a balance between minimizing potential harms to patients caused by initiating discussions of MAID and the imperative to inform and counsel patients about all of their legally available medical options. Practice implicationsClinicians should be aware of both the importance of communication as a tool to inform patients and the potential for clinical language to cause harm to or to unduly influence patients.

Autonomy Challenges in Epigenetic Risk-Stratified Cancer Screening: How Can Patient Decision Aids Support Informed Consent?

Information of an individual’s epigenome can be useful in cancer screening to enable personalised decision making on participation, treatment options and further screening strategies. However, adding this information might result in complex risk predictions on multiple diseases, unsolicited findings and information on (past) environmental exposure and behaviour. This complicates informed consent procedures and may impede autonomous decision-making. In this article we investigate and identify the specific features of epigenetic risk-stratified cancer screening that challenge the current informed consent doctrine. Subsequently we describe current and new informed consent models and the principle of respect for autonomy and argue for a specific informed consent model for epigenetic risk-stratified screening programmes. Next, we propose a framework that guides the development of Patient Decision Aids (PDAs) to support informed consent and promote autonomous choices in the specific context of epigenetic cancer screening programmes.

Recent insights into decision-making and their implications for informed consent

Research from behavioural sciences shows that people reach decisions in a much less rational and well-considered way than was often assumed. The doctrine of informed consent, which is an important...

Where Did Informed Consent for Research Come From?

To understand the future of informed consent, we should pay attention to two ethical-legal sources in addition to the revised Common Rule. Physicians acting as investigators and patients serving as research subjects bring to that relationship a long history regarding consent to treatment, and everyone dealing with research ethics needs to be aware of the Nuremberg Code and other human-rights documents. These three streams make separate and distinctly different contributions to informed consent doctrine.

手術とインフォームド・コンセント法理 : 外科医の立場から(第8回日本生命倫理学会年次大会シンポジウム「インフォームド・コンセントの功罪」)

手術とインフォームド・コンセント法理 : 外科医の立場から(第8回日本生命倫理学会年次大会シンポジウム「インフォームド・コンセントの功罪」)

Coming to Grips with the Ethical Challenges for Capital Post-Conviction Representation Posed by Martinez v. Ryan

In its groundbreaking decision in Martinez v. Ryan, 556 U.S. 1 (2012), the Supreme Court of the United States held that inadequate assistance of post-conviction counsel could be sufficient “cause” to excuse a procedural default thus allowing a federal court in habeas corpus proceedings to reach the merits of an otherwise barred claim that an inmate was deprived of his Sixth Amendment right to the effective assistance of counsel at trial. The upshot of Martinez is that, if state post-conviction counsel unreasonably (and prejudicially) fails to raise a viable claim of ineffective assistance of trial counsel, then there is “cause” (and likely also prejudice), and thus a gateway to merits’ review of the claim in federal habeas corpus proceedings. This is potentially a good thing for many habeas petitioners, but creates a serious and as-yet unappreciated ethical problem for federal habeas counsel who also served as state post-conviction counsel. In capital post-conviction cases, the pre-Martinez preference and practice was for continuity of counsel from state to federal court. Now that ineffective representation in state post-conviction proceedings can serve as a basis for review of otherwise defaulted claims, however, a lawyer may be materially limited in her ability to provide ongoing representation by the client’s interest in asserting an ineffectiveness claim.Lawyers who practice in the area of civil litigation or transactional representation are familiar with these “prior work” conflicts and the solution to them, which is to obtain the informed consent of the affected client after full disclosure of the facts giving rise to the conflict and the available alternatives. In the capital habeas context, however, the usual apparatus of professional responsibility law, including the informed consent doctrine and the potential of malpractice liability for mis-handling a conflict, are ill-suited to dealing with the problem thrust upon petitioners’ counsel by Martinez. Ironically, even though the tort doctrine of malpractice and the rules of professional conduct are both intended to protect clients, the rules allow the possibly negligent lawyer to decide whether client protection requires disclosure and consent, or possibly withdrawal from representation. Given the significance of ineffective assistance of counsel in capital cases, however, this kind of self-monitoring would be intolerable. Hence, the puzzle presented by Martinez, which recognizes the inability of lawyers to self-monitor, but fails to provide a mechanism for ensuring that the client’s rights are adequately protected.We suggest, therefore, that petitioners’ counsel cannot bear the sole responsibility for solving the Martinez dilemma. The other systemic and repeat players – States’ attorneys and judges – also have to do their part. After all, it is the invocation of procedural defenses in an effort to preclude merits’ review of the habeas petitioner’s federal constitutional claims that creates the procedural morass we have described. This in turn leads to both inefficient litigation and unjust results. Thus, in most instances, if attorneys for the state agreed – either on their own or after being “leaned on” by the court – waived procedural default and allowed the court to proceed to the merits, litigation would proceed expeditiously and without the ethical taint of potential and actual conflicts of interest. If the claims are not bona fide, they will be rejected. On the other hand, if the issues not previously raised are in fact meritorious, then there are no true “losers” unless you are of the view that death sentences resulting from a trial infected with prejudicial constitutional error should be carried out. Without some cooperative solution, courts will be faced with motions for substitution of counsel or the appointment of independent counsel to evaluate the performance of state post-conviction counsel; state attorneys general will have to deal with the possibility of further delay while the conflict issue is adjudicated. Thus, our tentatively hopeful conclusion to this exploration of the conundrum of Martinez is that the institutional actors with a stake in procedures and outcomes will work together to create an avenue for credible claims of inadequate state post-conviction representation to be investigated competently, for clients to be fully informed and involved in the decision-making process, and ultimately the client’s wishes respected.

Resisting Commensurability: Against Informed Consent as an Anthropological Virtue

In this article, I examine anthropology's embrace of the informed consent doctrine at the end of the 1990s. Although acknowledging its utility in resolving the tensions between disciplinary ideals of openness in field research and the diverse array of contexts in which anthropologists now work, I argue that it has not been in our best interest to co-opt the concept. Bringing together the prior critiques of the informed consent doctrine's application to ethnography, I criticize the tendency of some ethnographers to characterize ethnographic practice as “insuperably flawed,” pointing instead to the problems with the doctrine itself. I tease out underlying assumptions about the nature of research (and researchers and research subjects) that it presumes, and I conclude by suggesting the need for anthropology take a principled stance against the informed consent doctrine.

Finland on a Road towards a Modern Legal Biobanking Infrastructure

Finland has enacted a Biobank Act that will come into force on 1 September 2013. Finland is regarded as a highly successful environment for medical research using population samples and data for many reasons. One of the rationales behind the new legislation was to solve the problems due to the overly strict informed consent doctrine hindering access to old samples and data and asking for multi-purpose consents. Yet although consent is the primary justification to use biobank samples and data, the Biobank Act allows asking for a consent for several unspecified future research purposes. The guiding principles of the Biobank Act are promotion of trust, equal access to data and samples, protection of privacy, acceleration of innovation activities, and bringing biobank activities under public scrutiny. To the author's knowledge, this is the first "all purpose" Biobank Act in Europe applied to all biobanks in one country.

Intersexuality and the Law: Why Sex Matters. By Julie A. Greenberg. New York: New York University Press, 2012. 169 pp. $32.00 cloth.

Intersexuality and the Law: Why Sex Matters. By Julie A. Greenberg. New York: New York University Press, 2012. 169 pp. $32.00 cloth.For nearly fifteen years, Julie Greenberg's scholarship has illuminated the complex legal and social issues faced by individuals. Her new book, Intersexuality and the Law, synthesizes and develops upon her previous scholarship. It not only provides a comprehensive review of the law's past and present treatment of intersexuality, but also offers strategic suggestions for the future and, perhaps most importantly, democratizes the debate by making it accessible to those without legal training. Greenberg uses (and I have used) the term intersex to refer to individuals a congenital condition whose sex chromosomes, gonads, or internal or external sexual anatomy do not fit clearly into the binary male/ female norm (p. 1). She, however, acknowledges and discusses the fact that some have advocated replacing the term intersex with disorders of sex development (DSD).The book is divided into three parts. Part I describes the historical perception of individuals as 'freaks' (p. 11), as well as the historical treatment of infants through genitalnormalizing surgeries. Greenberg's descriptions illustrate the stereotyping inherent in doctors' sex-selection processes: For infants with XY chromosomes, the size of the penis was generally determinative, whereas for infants with XX chromosomes, the focus was on reproductive capacity. While practices have improved and the feminization of XY infants is now less common, Greenberg reports that many doctors continue to perform surgeries, without regard for the possibility that they may be destroying the ability to experience sexual satisfaction. Recognizing that individuals are not monolithic in their views of the surgeries, Greenberg carefully assesses the circumstances under which doctors should legally be able to operate. She explains that informed consent doctrine is designed to protect patient autonomy, but that when minors are involved parents often have substantial latitude to make decisions. After exploring the competing rights and potentially conflicting interests of infants and their parents, Greenberg makes two recommendations: first, that judicial approval be required prior to any surgery that will result in sterility and, second, that some type of safeguard be implemented prior to other surgeries.Part II assesses the legal mechanisms for sex determination in three contexts: marriage, official documentation, and housing and bathroom use. Beginning with marriage, Greenberg situates the issues faced by individuals within the broader context of social opposition to same-sex marriage-which, she explains, is the driving force behind the law's strict adherence to sex-based distinctions. …

Three arguments against prescription requirements

In this essay, I argue that prescription drug laws violate patients' rights to self-medication. Patients have rights to self-medication for the same reasons they have rights to refuse medical treatment...

Cardiac Imaging Modalities With Ionizing Radiation: The Role of Informed Consent

Informed consent ideally results in patient autonomy and rational health care decisions. Frequently, patients face complex medical decisions that require a delicate balancing of anticipated benefits and potential risks, which is the concept of informed consent. This balancing process requires an understanding of available medical evidence and alternative medical options, and input from experienced physicians. The informed consent doctrine places a positive obligation on physicians to partner with patients as they try to make the best decision for their specific medical situation. The high prevalence and mortality related to heart disease in our society has led to increased cardiac imaging with modalities that use ionizing radiation. This paper reviews how physicians can meet the ideals of informed consent when considering cardiac imaging with ionizing radiation, given the limited evidence for risks and benefits. The goal is an informed patient making rational choices based on available medical information.

Evolving Medicolegal Concepts: Editorial Comment

Evolving Medicolegal Concepts: Editorial Comment

What to disclose? Revisiting informed consent.

The requirement of obtaining informed consent before medical procedures is well established. With patients having greater access to information through information technology and owing to other factors, disclosure that goes beyond the traditional elements of the risks, benefits, and alternatives to an intervention is demanded from physicians. We asked if modern informed consent doctrine encompasses such physician-specific variables like professional experience, health, disability, training, qualifications, disciplinary history, FDA-regulatory status pertaining to a medical device, physician research and financial interests, and statistics related to medical outcomes. We searched two major legal databases and identified court opinions and legal reviews that have examined the scope of physician disclosure while obtaining informed consent. From this information, we summarized the prevailing state of informed consent law. Despite the expansion of information available to patients, courts have been hesitant to expand the informed consent doctrine to encompass physician-specific variables. Exceptions involve cases in which such variables directly impacted medical care and the patient could demonstrate their relevance in the informed consent process. Judicial decisions have subtly expanded the doctrine of informed consent beyond its traditional limits, at least in some cases. As informed consent law continues to develop, physicians should ask if information would be material to a reasonable patient while making medical decisions; if so, such information should be disclosed.

Personalized Disclosure by Information-on-Demand: Attending to Patients' Needs in the Informed Consent Process

Obtaining informed consent has typically become a stylized ritual of presenting and signing a form, in which physicians are acting defensively and patients lack control over the content and flow of information. This leaves patients at risk both for being under-informed relative to their decisional needs and of receiving more information than they need or desire. By personalizing the process of seeking and receiving information and allowing patients to specify their desire for information in a prospective manner, we aim to shift genuine control over the informational process to patients. A new paradigm of Information on Demand, such as we suggest, would also enhance legal certainty, achieve greater congruence between the information patients want and the information they receive, and promote more meaningful patient-physician interactions, a desirable outcome that has been difficult to achieve by other means.

Reproductive Choices and Informed Consent: Fetal Interests, Women's Identity, and Relational Autonomy

In this Article, I describe and examine the severe shortcomings in women's autonomy in the context of reproductive choices in the medical arena. The reproductive choices I explore are those choices that involve gestation: abortion, fertility treatments, and interventions during pregnancy. Due to state and medical interests in the fetus, I describe how information conveyed to patients making reproductive choices is biased towards fetal interests, relies on female stereotypes, and is still conveyed with the objective authority of the medical profession. Moreover, reproductive choices implicate women's values and identity interests that reach beyond medical concerns, which are not part of the informed consent doctrine at all. The narrow, individualistic informed consent torts doctrine intended to protect patient autonomy does not do enough in this context to balance bias nor does it mandate discussion of important identity interests and values. Accordingly, I argue that when faced with reproductive choices, women are not provided the balanced and comprehensive information needed to promote their autonomy. In response to the breakdown in patient autonomy I describe, instead of leaving women alone to make choices or regulating in order to protect them from their choices, a broader framework for supporting reproductive choices should be established. In light of the interdependence of woman and fetus, as well as the broader social context shaping these decisions, I argue that a more contextual, relational perspective of autonomy should be the goal of informed consent in the context of reproductive choices. I suggest a number of reforms that aim to optimize patient autonomy from a relational perspective. I suggest a broad, deliberative doctor-patient consultation and legal reforms that create more balance between the pull towards intervention and fetal protection on the one hand, and non-intervention and protection of women's personal identity interests on the other.

A Brief Historical and Theoretical Perspective on Patient Autonomy and Medical Decision Making: Part II: The Autonomy Model

As part of a larger series addressing the intersection of law and medicine, this essay is the second of two introductory pieces. Beginning with the Hippocratic tradition and lasting for the next 2,400 years, the physician-patient relationship remained relatively unchanged under the beneficence model, a paternalistic framework characterized by the authoritative physician being afforded maximum discretion by the trusting, obedient patient. Over the last 100 years or so, in response to certain changes taking place in both research and clinical practice, the bioethics movement ushered in the autonomy model, and with it, a profoundly different way of approaching decision making in medicine. The shift from the beneficence model to the autonomy model is governed legally by the informed consent doctrine, which emphasizes disclosure to patients of information sufficient to permit them to make intelligent choices regarding treatment alternatives. As this legal doctrine became established, philosophers identified an inherent value in respecting patients as autonomous agents, even where patient choice seems to conflict with the physician's duty to act in the patient's best interests. Whereas the beneficence model presumed that the physician knew what was in the patient's best interests, the autonomy model starts from the premise that the patient knows what treatment decision is in line with his or her true sense of well-being, even where that decision is the refusal of treatment and the result is the patient's death.