Bioethics for clinicians: 2. Disclosure.

In the context of patient consent, "disclosure" refers to the provision of relevant information by the clinician and its comprehension by the patient. Both elements are necessary for valid consent. Disclosure should inform the patient adequately about the treatment and its expected effects, relevant alternative options and their benefits and risks, and the consequences of declining or delaying treatment. The clinician''s goal is to disclose information that a reasonable person in the patient''s position would need in order to make an informed decision. Therefore, clinicians may need to consider how the proposed treatment (and other options) might affect the patient''s employment, finances, family life and other personal concerns. Clinicians may also need to be sensitive to cultural and religious beliefs that can affect disclosure.     

The Double Helix: Applying an Ethic of Care to the Duty to Warn Genetic Relatives of Genetic Information

Genetic testing reveals information about a patient's health status and predictions about the patient's future wellness, while also potentially disclosing health information relevant to other family members. With the increasing availability and affordability of genetic testing and the integration of genetics into mainstream medicine, the importance of clarifying the scope of confidentiality and the rules regarding disclosure of genetic findings to genetic relatives is prime. The United Nations International Declaration on Human Genetic Data urges an appreciation for principles of equality, justice, solidarity and responsibility in the context of genetic testing, including a commitment to honoring the privacy and security of the person tested. Considering this global mandate and recent professional statements in the context of a legal amendment to patient privacy policies in Australia, a fresh scrutiny of the legal history of a physician's duty to warn is warranted. This article inquiries whether there may be anything ethically or socially amiss with a potential future recommendation for health professionals or patients to universally disclose particular cancer predisposition genetic diagnosis to genetic family members. While much of the discussion remains applicable to all genetic diagnosis, the article focuses on the practice of disclosure within the context of BRCA1/2 diagnosis. An ‘ethic of care’ interpretation of legal tradition and current practice will serve to reconcile law and medical policy on the issue of physician disclosure of genetic results to family members without patient consent.     

Informed Consent in California: Latent Liability Without `Negligence'

Informed consent is a legal obligation due from a physician to his patient, an obligation which may not be met by the physician''s skillful treatment of his patient. It may only be met by the treating physician obtaining from his patient knowing authorization for carrying out the intended medical procedure. The physician is required to disclose whatever would be material to his patient''s decision, including the nature and purpose of the procedure, and the risks and alternatives. The disclosures should be made by the physician to his patient, and not through use of consent forms which are not particular to individual patients. To minimize any subsequent claim by the patient that there was a lack of adequate disclosures, the physician should record in the patient''s chart the circumstances of the patient''s consent, and should not rely on the patient''s unreliable ability to recall those circumstances.     

Informed consent and the disclosure of risks of treatment: the Supreme Court of Canada decides

Two 1980 decisions on informed consent by the Supreme Court of Canada are discussed. The court found the duty of disclosure of risks to be based in negligence and not battery. The physician's duty to disclose "material risks" was held to include some nonmedical elements related to the patient's questions and "reasonable" needs.     

Bioethics for clinicians: 8. Confidentiality

Physicians are obliged to keep information about their patients secret. The understanding that the physician will not disclose private information about the patient provides a foundation for trust in the therapeutic relationship. Respect for confidentiality is firmly established in codes of ethics and in law. It is sometimes necessary, however, for physicians to breach confidentiality. Physicians should familiarize themselves with legislation in their own province governing the disclosure of certain kinds of information without the patient''s authorization. Even when no specific legislation applies, the duty to warn sometimes overrides the duty to respect confidentiality. The physician should disclose only that information necessary to prevent harm, and should reveal this information only to those who need to know it in order to avert harm. Whenever possible any breach of confidentiality should be discussed with the patient beforehand.     

Informed consent and genomic incidental findings: IRB chair perspectives

It is unclear how genomic incidental finding (GIF) prospects should be addressed in informed consent processes. An exploratory study on this topic was conducted with 34 purposively sampled Chairs of institutional review boards (IRBs) at centers conducting genome-wide association studies. Most Chairs (96%) reported no knowledge of local IRB requirements regarding GIFs and informed consent. Chairs suggested consent processes should address the prospect of, and study disclosure policy on, GIFs; GIF management and follow-up; potential clinical significance of GIFs; potential risks of GIF disclosure; an opportunity for participants to opt out of GIF disclosure; and duration of the researcher's duty to disclose GIFs. Chairs were concerned about participant disclosure preferences changing over time; inherent limitations in determining the scope and accuracy of claims about GIFs; and making consent processes longer and more complex. IRB Chair and other stakeholder perspectives can help advance informed consent efforts to accommodate GIF prospects.     

'Hitting you over the head': oncologists' disclosure of prognosis to advanced cancer patients

The disclosure of prognosis to terminally ill patients has emerged as a recent concern given greater demands for patient involvement in medical decision-making in the United States. As part of the informed consent process, American physicians are legally and ethically obligated to provide information to such patients about the risks, benefits, and alternatives of all available treatment options including the use of experimental therapies. Although not legally required, the disclosure of a terminal prognosis is ethically justified because it upholds the principle of self-determination and enables patients to make treatment decisions consistent with their life goals. To understand oncologists' attitudes about disclosing prognostic information to cancer patients with advanced disease, we interviewed fourteen oncologists and conducted one focus group of medical fellows. Although oncologists reported to disclose prognosis in terms of cancer not being curable, they tend to avoid using percentages to convey prognosis. Oncologists' reported reluctance to disclosing prognosis was conveyed through the use of metaphors depicting the perceived violent impact of such information on patients. Oncologists' reluctance to disclose prognosis and preserve patient hope are held in check by their need to ensure that patients have 'realistic expectations' about therapy. We discuss these data in light of the cultural, ethical, and legal dimensions of prognosis disclosure, patient hope and the doctor–patient relationship, and recommend ways to enhance the communication process.     

Informed consent and nudging

In order to avoid patient abuse, under normal situations before performing a medical intervention on a patient, a physician must obtain informed consent from that patient, where to give genuine informed consent a patient must be competent, understand her condition, her options and their expected risks and benefits, and must expressly consent to one of those options. However, many patients refrain from the option that their physician believes to be best, and many physicians worry that their patients make irrational healthcare decisions, hindering their ability to provide efficient healthcare for their patients. Some philosophers have proposed a solution to this problem: they advocate that physicians nudge their patients to steer them towards their physician's preferred option. A nudge is any influence designed to predictably alter a person's behavior without limiting their options or giving them reasons to act. Proponents of nudging contend that nudges are consistent with obtaining informed consent. Here I argue that nudging is incompatible with genuine informed consent, as it violates a physician's obligation to tell their patients the truth, the whole truth, and nothing but the truth during adequate disclosure.     

Documenting wife abuse: a guide for physicians

An estimated 12% to 30% of women are assaulted by their male partners at least once during the relationship. Therefore, in their everyday practice, physicians are likely to encounter women who have suffered domestic abuse. The authors define wife abuse, outline epidemiologic aspects and discuss common signs and symptoms. In cases of suspected or confirmed abuse, it is very important for physicians to document the details of the injuries, the patient visit, any treatment and follow-up as well as to screen for associated conditions and ensure that any samples taken are not tampered with. When asked to disclose information by police or courts, physicians need to know when they are obliged to submit copies of their patients'' medical records, when patient consent is required, what information should be divulged and how to defend this information in court. The authors present information about the necessary, relevant and appropriate evidence to be collected and documented for both medical and legal purposes. They also discuss the criminal justice system and the role of physicians in legal proceedings concerning wife abuse.     

Disclosure of Huntington's disease to family members: the dilemma of known but unknowing parties

Predictive genetic testing presents unique issues in the legal and ethical debate concerning disclosure of information within the physician-patient relationship. A duty to disclose information to family members has been found when the disclosure is likely to result in the ability to mitigate the damaging effects of the disease. When evaluating the situation where a individual is at risk of Huntington's disease, the analysis must be different, as shown in this paper, and necessitates an ethical and legal examination of the consequences of receipt of the information on family members, those known but unknowing parties who are at risk of inheriting a genetic disease. This paper analyzes the potential legal duty of a physician to disclose or withhold genetic information from the family members of patients. Existing statutes governing genetic information do not directly address the interests of family members. Courts that have ruled on the duty to disclose medical or genetic information have analyzed these issues using traditional concepts of tort law. Yet the situation presented by Huntington's disease is unique and demands a different framework for analysis, given the late onset and lack of curative or ameliorative treatment. This paper also analyzes the ethical standards to be invoked when considering violating the privacy of a patient or a family member. The principles of autonomy and self-determination of family members are considered, versus the risk of harm and the privacy interest in not knowing potentially devastating information.     

Findings of negligence followed communication lapses in BC aneurysm case

Negligence is sometimes established on the basis of lapses in communication and patient care management that, in hindsight, could have been avoided. A recent BC court case concerned a patient who died because of a ruptured aneurysm. A Supreme Court judge found that some of the physicians involved had failed in their duty to diagnose the patient''s condition properly, or failed to communicate to one another significant signs of the patient''s illness, and failed to refer him in time to the medical specialists who could have diagnosed and treated his condition promptly.     

Managing familial risk in genetic testing

Increasing numbers of people are seeking genetic testing and uncovering information that directly concerns their biological relatives as well as themselves. This familial quality of genetic information raises ethical quandaries for physicians, particularly related to their duty of confidentiality. In this article, the American Medical Association's Council on Ethical and Judicial Affairs examines the informed consent process in the specific context of genetic testing, giving particular consideration to the handling of information that has consequences for biological relatives. Furthermore, it addresses the question of whether physicians' obligation to warn biological relatives ever should override the obligation to protect patient confidentiality.     

Physicians and the minefield surrounding informed consent.

Most of the legal cases that follow the informed-consent standard set in recent court cases have involved surgical procedures. However, issues concerning a pregnant British Columbia mother who contracted chicken pox and whose child was subsequently born with severe medical complications demonstrate the complexity of medical decision making and the inadequacy of established legal requirements, especially when consent has dimensions beyond technical considerations usually associated with medical procedures. The problem physicians face, says lawyer Karen Capen, is to find a way to balance a range of professional responsibilities and the overriding fiduciary obligation to patients in matters associated with informed decision making and consent.     

RESPECTING AUTONOMY WITHOUT DISCLOSING INFORMATION

There is widespread agreement that it would be both morally and legally wrong to treat a competent patient, or to carry out research with a competent participant, without the voluntary consent of that patient or research participant. Furthermore, in medical ethics it is generally taken that that consent must be informed. The most widely given reason for this has been that informed consent is needed to respect the patient's or research participant's autonomy. In this article I set out to challenge this claim by considering in detail each of the three most prominent ways in which ‘autonomy’ has been conceptualized in the medical ethics literature. I will argue that whilst these accounts support the claim that consent is needed if the treatment of competent patients, or research on competent individuals, is to respect their autonomy, they do not support the claim that informed consent is needed for this purpose.     

How Are the Interests of Incapacitated Research Participants Protected through Legislation? An Italian Study on Legal Agency for Dementia Patients

Background

Patients with dementia may have limited capacity to give informed consent to participate in clinical research. One possible way to safeguard the patients'' interests in research is the involvement of a proxy in the recruitment process. In Italy, the system of proxy is determined by the courts. In this study we evaluate the timing for appointment of a legal proxy in Italy and identify predictive variables of appointment.

Methodology/Principal Findings

Subjects were recruited among the outpatients seeking medical advice for cognitive complaints at the Centre for Research and Treatment of Cognitive Dysfunctions, University of Milan, “Luigi Sacco” Hospital.The Centre was participating to the AdCare Study, a no-profit randomised clinical trial coordinated by the Italian National Institute of Health. The requirement that informed consent be given by a legal representative dramatically slowed down the recruitment process in AdCare, which was prematurely interrupted. The Centre for Research and Treatment of Cognitive Dysfunctions collected data on the timing required to appoint the legal representatives. Patients diagnosed with dementia and their caregivers were provided information on the Italian law on legal agency (law 6/2004). At each scheduled check-up the caregiver was asked whether she/he had applied to appoint a legal proxy for the patient and the time interval between the presentation of the law, the registration of the application at the law court chancellery and the sentence of appointment was registered. The study involved 169 demented patients. Seventy-eight patients (46.2%) applied to appoint a legal proxy. These subjects were usually younger, had been suffering from dementia for a longer time, had less than two children and made more use of memantine. The mean interval time between the presentation of the law and the patients'' application to the law court chancellery was two months. The mean interval time between the patient''s application to the law court chancellery and the sentence of appointment was four months.

Conclusions/Significance

In Italy the requirement that legal representatives be appointed by the courts slows down subjects'' participation in research. Other procedures for legal agency of the incapacitated patients may be adopted, taking as examples other EU countries'' systems.     

Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer.

Methods of obtaining informed consent have evolved differently in Western countries without substantive information on the impact of these different practices on the patients. A randomised study was performed to compare two commonly adopted methods of seeking consent to randomised treatment: an individual approach at the discretion of each doctor and a uniform policy of total disclosure of all relevant information. The impact of both consent procedures on the patient''s understanding and anxiety levels and on the doctor-patient relationship was assessed by means of a questionnaire given soon after the consent interview. Fifty seven patients were assigned at random to two groups: to 29 patients an individual approach to seeking consent was adopted and to 28 patients all relevant information was given. Seven patients refused consent to randomised treatment, with slightly more refusals by patients in the total disclosure group (5 v 2, p = 0.25). The main effects of total disclosure of all information compared with an individual approach to seeking consent were: a better understanding of treatment and side effects and of research aspects of the treatments; less willingness to agree to randomised treatment; and increased anxiety. No significant differences were found in patients'' perceptions of the doctor-patient relationship. A repeat questionnaire given three to four weeks later no longer showed significant differences between the two groups.     

Bioethics for clinicians: 14. Ethics and genetics in medicine

Information about a patient''s inherited risk of disease has important ethical and legal implications in clinical practice. Because genetic information is by nature highly personal yet familial, issues of confidentiality arise. Counselling and informed consent before testing are important in view of the social and psychological risks that accompany testing, the complexity of information surrounding testing, and the fact that effective interventions are often not available. Follow-up counselling is also important to help patients integrate test results into their lives and the lives of their relatives. Genetic counselling should be provided by practitioners who have up-to-date knowledge of the genetics of and the tests available for specific diseases, are aware of the social and psychological risks associated with testing, and are able to provide appropriate clinical follow-up. Some physicians may elect to refer patients for genetic counselling and testing. However, it is inevitable that all physicians will be involved in long-term follow-up both by monitoring for disease and by supporting the integration of genetic information into patients'' lives.     

The ethics of learning from patients

Is it ethical for medicine to use patients as learning tools for medical students if these patients have not been given a chance to provide truly informed consent? Dr. Caroline Shooner raises this question in the following article, which claimed second prize in CMAJ''s 1996 Logie Medical Ethics Essay Contest. She considers the case of a patient whose trust was shaken when a medical student performed a chest-tube insertion. Shooner concludes that psychologic harm could have been avoided had the patient''s right to informed consent been respected. She also argues that few patients will turn down a chance to help students learn if the request is made properly and openly.     

Medical Ghostwriting and Informed Consent

Ghostwriting in its various forms has received critical scrutiny from medical ethicists, journal editors, and science studies scholars trying to explain where ghostwriting goes wrong and ascertain how to counter it. Recent analyses have characterized ghostwriting as plagiarism or fraud, and have urged that it be deterred through stricter compliance with journal submission requirements, conflict of interest disclosures, author‐institutional censure, legal remedies, and journals' refusal to publish commercially sponsored articles. As a supplement to such efforts, this paper offers a critical assessment of medical ghostwriting as contrary to good patient care, on the grounds that it contradicts established general principles guiding clinical ethics. Specifically, I argue that ghostwriting undermines trust relationships between authors and their readers, and between these readers and their trusting patients, and in so doing contradicts the duty of respect for patient autonomy by obstructing informed consent. For this reason, complicity in ghostwriting practices should be understood as a violation of the professional ethical duties of physicians and other healthcare workers.     

Should consent be required for organ procurement?

Must we obtain a patient's consent before posthumously removing her organs? According to the consent requirement, in order to permissibly remove organs from a deceased person, it is necessary that her prior consent be obtained. If the consent requirement is true, then this seems to rule out policies that do not seek and obtain a patient's prior consent to organ donation, while at the same time vindicating policies that do seek and obtain patient consent. In this paper, however, I argue that once we recognize the difference between consent, on the one hand, and wishing or desiring, on the other, we will see that obtaining consent before organ removal is neither necessary nor sufficient to respect patient autonomy in organ procurement.