Clinicians cannot obtain valid consent to treatment because they cannot guess which treatment option will serve a particular patient's best interests. These guesses could be made more accurately if patients were paired with providers who share their deep values.

Many accounts of informed consent in medical ethics claim that it is valuable because it supports individual autonomy. Unfortunately there are many distinct conceptions of individual autonomy, and their ethical importance varies. A better reason for taking informed consent seriously is that it provides assurance that patients and others are neither deceived nor coerced. Present debates about the relative importance of generic and specific consent do not address this issue squarely. Consent is a propositional attitude, so intransitive: complete, wholly specific (...) consent is an illusion. Since the point of consent procedures is to limit deception and coercion, they should be designed to give patients and others control over the amount of information they receive and opportunity to rescind consent already given. (shrink)

: Managed care per se is a morally neutral concept; however, as practiced today, it raises serious ethical issues at the clinical, managerial, and social levels. This essay focuses on the ethical issues that arise at the bedside, looking first at the ethical conflicts faced by the physician who is charged with responsibility for care of the patient and then turning to the way in which managed care exacts costs that are measured not in dollars but in compromises in the (...) caring dimensions of the patient-physician relationship. (shrink)

Introduction US data reveal a Caesarean rate discrepancy between insured and uninsured patients, with the C-section rate highest among the privately insured. The data have prompted concern that financial incentives associated with insurance status might influence American physicians' decisions to perform Caesarean deliveries. Objective To determine whether differences in medical risk factors account for the apparent Caesarean rate discrepancy between Medicaid and privately insured patients in Michigan, USA. Method A retrospective review was performed of 617 269 live birth deliveries in (...) Michigan hospitals during 2004–8. All live birth records that were able to be linked to their mothers' hospital discharge records were utilised. Diagnosis-related group codes from the hospitalisation records were used to identify Caesarean deliveries. Regression models determined Caesarean probability for the time period under study, adjusted for insurance type, maternal age, race, maternal medical conditions, multiple births, prematurity and birth weight. Results From 2004 to 2008, Caesarean rates were 33% for privately insured patients and 29% for Medicaid patients. The probability of Caesarean delivery was significantly greater for privately insured than Medicaid patients on univariate analysis (OR 1.2, 95% CI 1.19 to 1.22) but not on multivariate analysis (adjusted OR 1.01, 95% CI 0.99 to 1.02). Conclusion No significant disparity was found in the odds of Caesarean delivery between privately insured and Medicaid patients in Michigan after adjusting for other Caesarean risk factors. A positive disparity would have provided de facto evidence that financial incentives play a role in physician decision-making regarding Caesarean delivery. (shrink)

: The way patients make health care decisions is much more complicated than is often recognized. Patient autonomy allows both that patients will sometimes defer to clinicians and that they should sometimes be active inquirers, ready to question their clinicians and do some independent research. At the same time, patients' active inquiry requires clinicians' support.

Conflicts of interest can lead experts to give biased and corrupt advice. Although disclosure is often proposed as a potential solution to these problems, we show that it can have perverse effects. First, people generally do not discount advice from biased advisors as much as they should, even when advisors’ conflicts of interest are disclosed. Second, disclosure can increase the bias in advice because it leads advisors to feel morally licensed and strategically encouraged to exaggerate their advice even further. As (...) a result, disclosure may fail to solve the problems created by conflicts of interest and may sometimes even make matters worse. (shrink)

The nocebo effect, the mirror-phenomenon to the placebo effect, is when the expectation of a negative outcome precipitates the corresponding symptom or leads to its exacerbation. One of the basic ethical duties in health care is to obtain informed consent from patients before treatment; however, the disclosure of information regarding potential complications or side effects that this involves may precipitate a nocebo effect. While dilemmas between the principles of respect for patient autonomy and of nonmaleficence are recognized in medical ethics, (...) there has not yet been an ethical discussion focused on the potential dilemma raised by the nocebo effect of informed consent. This dilemma is especially pernicious, since it involves a direct causality of harm by the caregiver that is unparalleled by other potential harmful effects of information disclosure. This paper articulates the dilemma of the NEIC and offers a seminal ethical analysis. (shrink)

Empirical research has proven the influence exerted by the medical industry on physicians’ decision-making. Physicians are the gatekeepers who determine how money is spent within the healthcare system. Hence, they are the target group of powerful lobbies in the field, i.e. the manufacturers of medical devices and the pharmaceutical industry. As clinical research lies in the hands of physicians, they play an exclusive and central role in launching new medical products. There are many ethical problems involved here: physicians may develop (...) a mindset of entitlement; biased decisions may put patients at risk; academic interests and research activities will no longer be free if they are influenced considerably by financial incentives; fair resource allocation may be restricted. An aspect that has been neglected so far is the administrators’ involvement as they not rarely expect physicians to acquire external financial resources from industry as benefits often lie with the institutions. To “protect” physicians from undue sway may be in the best interest of patients in order to guarantee a fair allocation of resources and to prevent the application of technologies (and medications) that would not have been used according to current standards of care. The latter may and obviously does put patients at risk. On the other hand, medico–industrial relations are of great importance. A considerable part of medical progress is driven by private industry. Yet, any co-operation between those who care for patients and industry ultimately has to serve the patient. Hence, strong policies to guide conduct are sorely needed. The following points are held to be pivotal in order to secure ethical conduct: (1) professional codes of ethics; (2) a stronger academic attitude amongst medical staff, (3) rules of transparency for medico−industrial relations including online disclosure and limiting scale of payments, (4) establishing rules (and laws) that ban unethical conduct and mandate vigorous surveillance of adherence to guidelines. (shrink)

: Arguments for efficiency in health care delivery have been used to support some level of withholding of information about available treatment options from patients in managed care systems. To the extent that such arguments prevail, they may necessitate changes in the established understanding of and commitment to informed consent and the disclosure of information to patients.

Much attention has been focused in recent years on the ethical acceptability of physicians receiving gifts from drug companies. Professional guidelines recognize industry gifts as a conflict of interest and establish thresholds prohibiting the exchange of large gifts while expressly allowing for the exchange of small gifts such as pens, note pads, and coffee. Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize. (...) Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated. (shrink)

Concerns over conflicts of interest in academic research and medical practice continue to provoke a great deal of discussion. What is most obvious in this discourse is that when COIs are declared, or perceived to exist in others, there is a focus on both the descriptive question of whether there is a COI and, subsequently, the normative question of whether it is good, bad or neutral. We contend, however, that in addition to the descriptive and normative, COI declarations and accusations (...) can be understood as performatives. In this article, we apply J.L. Austin’s performative speech-act theory to COI discourses and illustrate how this works using a contemporary case study of COI in biomedical publishing. We argue that using Austin’s theory of performative speech-acts serves to highlight the social arrangements and role of authorities in COI discourse and so provides a rich framework to examine declarations, accusations and judgements of COI that often arise in the context of biomedical research and practice. (shrink)

Informed consent is increasingly heralded as an ethical panacea, a tool to counter autocratic and paternalistic medical practices. Debate about the implementation of informed consent is constricted and polarised, centring on the right of individuals to be fully informed and to freely choose versus an autocratic, paternalistic practice that negates individual choice. A bioethical framework, based on a principle-led form of reductive/deductive reasoning, dominates the current model of informed consent. Such a model tends to abstract the process of consent from (...) its clinical and social setting. By fleshing out the social process involved when patients and healthy volunteer subjects consent to take part in clinical drug trials, this paper attempts to address the problem arising from the current ‘empty ethics’ model. My arguments are substantiated by qualitative interview data drawn from a study I conducted on the process of consent as experienced by participants in clinical drug trials. (shrink)

Much attention has been focused in recent years on the ethical acceptability of physicians receiving gifts from drug companies. Professional guidelines recognize industry gifts as a conflict of interest and establish thresholds prohibiting the exchange of large gifts while expressly allowing for the exchange of small gifts such as pens, note pads, and coffee. Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize. (...) Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated. (shrink)

Financial and nonfinancial conflicts of interest in medicine and surgery are troubling because they have the capacity to skew decision making in ways that might be detrimental to patient care and well-being. The recent case of the Articular Surface Replacement (ASR) hip provides a vivid illustration of the harmful effects of conflicts of interest in surgery.

In this paper we propose a theoretical framework for analysing the history and function of ethics as a form of regulation. Ethics in the form of codes, rules and declarations, constitutes regulatory policies, and we wish to suggest analysing such policies from an organizational perspective. In many instances ethics policies are reactions to particular events involving harm of patients or research participants. As such they seem to come forward as solutions to specific problems. However, not all such events that instigate (...) the making of new policies, and policies often have other effects and are used for other purposes than what we might expect from the events preceding them: when ethics takes on the form of policy making, the relationship between problems and solutions is more complex. We suggest that an organizational perspective on ethics codes, rules and declarations can deliver a relevant framework for future studies of the implications of wanting to address ethical problems through policy making. (shrink)