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In the American medical system, patients do not know the final price of treatment until long after the treatment is given, at which point it is too late to say "no." I argue that without price disclosure many, perhaps all, tokens of consent in clinical medicine fall below the standard of valid, informed consent. This is a sweeping and broad thesis. The reason for this thesis is surprisingly simple: medical services rarely have prices attached to them that are known to the patient prior to treatment. Yet, for many patients, knowledge of the price is relevant to whether they would give consent. If informed consent requires that patients know all information about their treatment that is relevant to their decision, then consent to a medical intervention in the absence of the price is not informed consent.

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Among various kinds of disclosures typically required in research as well as in clinical scenarios, risk information figures prominently. A key question is, what kinds of risk information would the reasonable person want to know? I will argue, however, that the reasonable person construct is and always has been incapable of settling this very question. After parsing the nebulous if not "contentless" character of the reasonable person, I will explain how Western courts have actually adjudicated cases of "negligent nondisclosure," that is, cases in which patient-plaintiffs allege that their informed consent rights were violated by the failure of their health providers to inform them of reasonably foreseeable risks that subsequently materialized. To support my argument, I will scrutinize the landmark decision by the United Kingdom's Supreme Court in Montgomery v. Lanarkshire Health Board and, in particular, Justice Brenda Hale's concurrence.

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In early March 2020, the March-April Hastings Center Report was very nearly assembled and contained nothing about Covid-19, which was still just beginning to make itself publicly known in the United States. Two weeks later, the editorial line-up was undergoing a remix, and essays that lay out sweeping agendas for the response to the worldwide crisis were in preparation. The central theme in the agenda that Lawrence O. Gostin and colleagues develop is that the pandemic requires a sharp break from usual ethical norms yet simultaneously demands a return to core ethical commitments. A similar theme is sounded by Mildred Z. Solomon and colleagues in a commentary calling for federal actions to keep the health care system functioning. Other essays in the issue take up an assortment of topical issues-including international patient dumping-that were simmering along prior to the pandemic, and the two articles take up foundational questions about the nature of moral reasoning.

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There is substantial published evidence showing that countless people enroll each year in ethically deficient clinical trials. Many of the trials are problematic because the quality of the science used to justify their launch may not be sufficiently vetted while many other trials may lack requisite social value. This poses the question: why do people volunteer for them? The answer resides in large part in the fact that informed consent practices have historically masked, rather than disclosed, the information that would alert research candidates to the ethically problematic nature of the trials. The "reasonable person" and "key information" provisions in the revised US Common Rule create the opportunity to correct this historical shortcoming. Two sources are employed to shed light on what the "key information" is that should be disclosed to a "reasonable person": the original disclosure aims of the Nuremberg Code, as well as an extensive body of meta-research evidence. Those sources jointly support a range of new disclosures in the informed consent process that would unmask the heretofore undisclosed information. The resulting proposed new disclosures pertain to the overall success prospects of clinical trials, the quality of the prior research that both forms the basis of clinical trials and informs assessment of their risks and benefits, the potential social value of clinical trials, and the commercial purposes of clinical trials.

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Laura Odwazny and Benjamin Berkman have raised several challenges regarding the new reasonable person standard in the revised Common Rule, which states that informed consent requires potential research subjects be provided with information a reasonable person would want to know to make an informed decision on whether to participate in a study. Our aim is to offer a response to the challenges Odwazny and Berkman raise, which include the need for a reasonable person standard that can be applied consistently across institutional review boards and that does not stigmatize marginal groups. In response, we argue that the standard ought to be based in an ordinary rather than ideal person conception of reasonable person and that the standard ought to employ what we call a liberal constraint: the reasonability standard must be malleable enough such that a wide variety of individuals with different, unique value systems would endorse it. We conclude by suggesting some of the likely consequences our view would have, if adopted.

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The law of informed consent to medical treatment has recently been extensively overhauled in England. The 2015 Montgomery judgment has done away with the long-held position that the information to be disclosed by doctors when obtaining valid consent from patients should be determined on the basis of what a reasonable body of medical opinion agree ought to be disclosed in the circumstances. The UK Supreme Court concluded that the information that is material to a patient's decision should instead be judged by reference to a new two-limbed test founded on the notions of the 'reasonable person' and the 'particular patient'. The rationale outlined in Montgomery for this new test of materiality, and academic comment on the ruling's significance, has focused on the central ethical importance that the law now (rightfully) accords to respect for patient autonomy in the process of obtaining consent from patients. In this paper, we dispute the claim that the new test of materiality articulated in Montgomery equates with respect for autonomy being given primacy in re-shaping the development of the law in this area. We also defend this position, arguing that our revised interpretation of Montgomery's significance does not equate with a failure by the courts to give due legal consideration to what is owed to patients as autonomous decision-makers in the consent process. Instead, Montgomery correctly implies that doctors are ethically (and legally) obliged to attend to a number of relevant ethical considerations in framing decisions about consent to treatment, which include subtle interpretations of the values of autonomy and well-being. Doctors should give appropriate consideration to how these values are fleshed out and balanced in context in order to specify precisely what information ought to be disclosed to a patient as a requirement of obtaining consent, and as a core component of shared decision-making within medical encounters more generally.

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The autonomy of patients participating in research means that a proper informed consent process must take place. This means that information must be given according to a reasonable person standard implying what legally and ethical a reasonable person participating in the research would want to know. The research must assure that the patient has understood all the information given and that a voluntary choice has been made. This means that no form of coercion must take place and that information must not be manipulated in such a way as to influence the participant. No undue pressure or persuasion must either occur. Particular attention must be paid to vulnerable groups and participants must be competent and have the capacity to consent. Where necessary the use of a proxy to act on behalf of a patient who does not have legal capacity must be used and the best interests of the patient must be asserted. In research consent must always include a signed consent form which again is duly explained and authorized by the research ethics committee.

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Algunos filósofos sostendrían que, si es cierto que tanto todo lo que hacemos como sus consecuencias dependen, en realidad, de la fuerza combinada de factores antecedentes y posteriores que no controlamos, podría no tener sentido que se nos responsabilice por las consecuencias de nuestras acciones. La responsabilidad jurídica, sin embargo, está a salvo de este ataque porque no pretende resolver esos problemas metafísicos: sólo tiene sentido si se la entiende como una construcción que refleja estándares de conducta razonable. El derecho presupone que podemos moderar nuestra conducta en función de los intereses de los demás en su seguridad y en su libertad y, por ello, presupone que es justo que se nos haga responsables por los costos que nuestras acciones les imponen.

Some philosophers would argue that, if it is true that, in fact, both our deeds and their consequences depend on the combined force of precedent and posterior factors that we do not control, it could make sense not to be blamed for the consequences of our deeds. Legal responsibility, however, is safe from this attack because it does not aim at resolving those metaphysical issues: it only makes sense if understood as a construction that reflects standards of reasonable behaviour. Law presupposes that we are able to moderate our conduct in light of the interests of others in their security and liberty and, therefore, it presupposes that it is fair to make us responsible of the costs that our deeds impose on them.

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