Unconsented pelvic exams under anesthesia are assaults cloaked in defense of healthcare education. Preemptive linguistic qualifiers “presumed” or “implied” attempt to justify such violations with flippancy toward their oxymoronic implications: to suggest a priori that consent can be assumed undermines its otherwise standalone social, ethical, and medico-legal reverence. In this paper I conceptualize “medical sexual assault” and argue that presumed consent for intimate exams exemplifies its definition. By bluntly describing pelvic exams as “penetration,” this work aims (...) to reify the intimate reality of the clinical label “pelvic exam” and to call attention to cisheteronormative and androcentric assumptions involved in its practice. Additionally, this scholarship seeks to create a foundation toward broader work in conceptualizing clinical rape culture. Given recent national survey data indicating a surprising frequency of unconsented intimate exams, detailed language as to their problematics is necessary for ongoing legal and ethical efforts. Explicit consent for intimate exams must be the standard of care for conscious and unconscious patients. (shrink)

I argue that a policy of presumed consent for cadaveric organ procurement, which assumes that people do want to donate their organs for transplantation after their death, would be a moral improvement over the current American system, which assumes that people do not want to donate their organs. I address what I take to be the most important objection to presumed consent. The objection is that if we implement presumed consent we will end up (...) removing organs from the bodies of people who did not want their organs removed, and that this situation is morally unacceptable because it violates the principle of respect for autonomy that underlies our concept of informed consent. I argue that while removing organs from the bodies of people who did not want them removed is unfortunate, it is morally no worse that not removing organs from the bodies of people who did want them removed, and that a policy of presumed consent will produce fewer of these unfortunate results than the current system. (shrink)

In the wake of scandals about the unauthorised retention of organs following postmortem examination, the issue of valid consent has returned to the forefront. Emphasis is put on obtaining explicit authorisation from the patient or family prior to any medical intervention, including those involving the dead. Although the controversies in the UK arose from the retention of human material for education or research rather than therapy, concern has been expressed that public mistrust could also adversely affect organ donation for (...) transplantation. At the same time, however, the British Medical Association continues to call for a shift to a system of presumed consent for organ transplantation. This apparent inconsistency can be justified because valid distinctions exist between the reasons requiring explicit consent for retention and the acceptability of presumed consent for transplantation. This paper argues for introducing a system of presumed consent for organ donation, given the overwhelming expressions of public support for transplantation. Ongoing legislative review in the UK provides an ideal chance to alter the default position to one where potential donors can simply acquiesce or opt out of donation. Combined with consultation with their relatives, this could be a much better method of realising individuals’ wishes. It would also achieve a better balance between the duties owed to the deceased and those owed to people awaiting a transplant. (shrink)

Current methods of obtaining consent for emergency neonatal research are flawed. They risk aggravating the distress of parents of preterm and other sick neonates. This distress, and the inevitable time constraints, compromise understanding and voluntariness, essential components of adequately informed consent. Current practice may be unjust in over-representing babies of more vulnerable and deprived parents. The research findings may thus not be generalisable. Informing parents antenatally about the possible need for emergency neonatal research, with presumed consent (...) and scope for opting out, would address these problems. It would spare parents of sick neonates, already terrified by their baby's illness, further distress. Experience with opting out suggests that recruitment might increase, thus generating earlier results, without compromising parental understanding of the nature and purpose of the research. (shrink)

Hip fractures are common and serious injuries in the geriatric population. Obtaining informed consent for surgery in geriatric patients can be difficult due to the high prevalence of comorbid cognitive impairment. Given that virtually all patients with hip fractures eventually undergo surgery, and given that delays in surgery are associated with increased mortality, we argue that there are select instances in which it may be ethically permissible, and indeed clinically preferable, to initiate surgical treatment in cognitively impaired patients under (...) the doctrine of presumed consent. In this paper, we examine the boundaries of the license granted by presumed consent and use the example of geriatric hip fracture to build an ethical framework for understanding the doctrine of presumed consent. The license to act under presumed consent requires three factors: patient incapacity, clinical urgency and clarity on the correct course of action. All three can apply to geriatric hip fracture. The typical patient frequently lacks capacity. Delays in initiating surgical treatment are associated with markedly increased mortality rates. Last, there appears to be consensus that surgery is the preferred treatment. Nonetheless, because there is a window of safe delay during which treating physicians can stabilize the patient, address reversible causes of cognitive impairment and identify surrogate decision makers, presumed consent should be invoked only as a method of last resort. A medical situation need not be characterized by risk of imminent and certain death for presumed consent to be relevant. Rather, there are two distinct windows that must be considered: the time interval in which action may be delayed without danger, and the time interval needed to obtain a better form of consent. Presumed consent is appropriate only when the latter exceeds the former. (shrink)

This article explores the meaning and moral significance of presumed consent with particular reference to an opt-out policy for postmortem organ donation. It does so under two general categories: circumstances where we believe consent to have been given and those where we have no reason to believe that it has either been given or been refused. In the context of an opt-out policy, the first category would relate to the idea of tacit consent. It is argued (...) both that substituting the term ‘presumed consent’ would be misleading and that it is unlikely that the conditions for tacit consent would be met in practice. Regarding the second category, where the claim would be one regarding counterfactual consent, two main points are made: that claims about consent are unwarranted, and also that they are unnecessary to moral argument, given that the moral work is done by reasons other than any supposedly provided by a presumption of consent. (shrink)

Every day in the United States 17 people die waiting for an organ transplant. The waiting list for organs, which now contains the names of 82,000 people, has more than tripled in the last 10 years. The U.S. policy on who can donate an organ is based both on previous consent of the potential donor and on the consent of the donor's family. This foundation greatly limits the number of potential donors. Spain is the world's leader in providing (...) organs to its population, and the underlying principle of their policy on donors in presumed consent. That is, those people who have not expressly opposed donating their organs are considered eligible for donation. This policy, along with a plan of public education and a strong infrastructure for organ procurement, is what has enhanced their donor rates. Spain is not alone: other countries have seen the benefits of presumed consent and the limits of opt-in systems. The United States must put to use the experiences of these countries to stem the tide of organ shortage and give new life to those desperately awaiting organs. a. (shrink)

United Kingdom Transplant reported that, during 2007—2008, a total of 7655 people were awaiting a transplant; however, only 3235 organs were available via the current `opt in' approach. To address this shortfall, new UK legislation sought to increase the number of organs available for donation. The Chief Medical Officer for England and Wales supports the adoption of `presumed consent' legislation, that is, an `opt out' approach, as used in much of Europe. Little research, however, has explored the impact (...) on bereaved relatives, nurses and medical staff of introducing presumed consent legislation. Adopting a phenomenological approach, this study used responses to an initial questionnaire combined with selected interviews with health care professionals to capture their direct experience of presumed consent legislation in three European countries: Portugal, Norway and Belgium. (shrink)

“Opt-out” organ procurement policies based on presumed consent are typically advertised as being superior to “opt-in” policies based on explicit consent at securing organs for transplantation. However, Michael Gill has argued that presumed consent policies are also better than opt-in policies at respecting patient autonomy. According to Gill’s Fewer Mistakes Argument, we ought to implement the procurement policy that results in the fewest frustrated wishes regarding organ donation. Given that the majority of Americans wish to (...) donate their organs, it is plausible that a presumed consent policy would result in fewer frustrated wishes compared to the current opt-in policy. It follows that we ought to implement a policy of presumed consent. In this paper, I first consider and find wanting an objection to the Fewer Mistakes Argument developed recently by Douglas MacKay. I also consider an objection put forth by James Taylor but argue that there is a methodological reason to prefer my own argument to Taylor’s. Finally, I argue for two theses: first, that Gill’s major argument in favor of the crucial premise of the Fewer Mistakes Argument is flawed, and second, that the major premise of the Fewer Mistakes Argument is false. (shrink)

Ben Saunders claims that actual consent is not necessary for organ donation due to ‘normative consent’, a concept he borrows from David Estlund. Combining normative consent with Peter Singer's ‘greater moral evil principle’, Saunders argues that it is immoral for an individual to refuse consent to donate his or her organs. If a presumed consent policy were thus adopted, it would be morally legitimate to remove organs from individuals whose wishes concerning donation are not (...) known. This paper disputes Saunders' arguments. First, if death caused by the absence of organ transplant is the operational premise, then, there is nothing of comparable moral precedence under which a person is not obligated to donate. Saunders' use of Singer's principle produces a duty to donate in almost all circumstances. However, this premise is based on a flawed interpretation of cause and effect between organ availability and death. Second, given growing moral and scientific agreement that the organ donors in heart-beating and non-heart-beating procurement protocols are not dead when their organs are surgically removed, it is not at all clear that people have a duty to consent to their lives being taken for their organs. Third, Saunders' claim that there can be good reasons for refusing consent clashes with his claim that there is a moral obligation for everyone to donate their organs. Saunders' argument is more consistent with a conclusion of ‘mandatory consent’. Finally, it is argued that Saunders' policy, if put into place, would be totalitarian in scope and would therefore be inconsistent with the freedom required for a democratic society. (shrink)

Organ donation after cessation of circulation and respiration, both controlled and uncontrolled, has been proposed by the Institute of Medicine as a way to increase opportunities for organ procurement. Despite claims to the contrary, both forms of controlled and uncontrolled donation after cardiac death raise significant ethical and legal issues. Identified causes for concern include absence of agreement on criteria for the declaration of death, nonexistence of universal guidelines for duration before stopping resuscitation efforts and techniques, and assumption of (...) class='Hi'>presumed intent to donate for the purpose of initiating temporary organ-preservation interventions when no expressed consent to donate is present. From a legal point of view, not having scientifically valid criteria of cessation of circulation and respiration for declaring death could lead to a conclusion that organ procurement itself is the proximate cause of death. Although the revised Uniform Anatomical Gift Act of 2006 provides broad immunity to those involved in organ-procurement activities, courts have yet to provide an opinion on whether persons can be held liable for injuries arising from the determination of death itself. Preserving organs in uncontrolled donation after cardiac death requires the administration of life-support systems such as extracorporeal membrane oxygenation. These life-support systems can lead to return of signs of life that, in turn, have to be deliberately suppressed by the administration of pharmacological agents. Finally, allowing temporary organ-preservation interventions without expressed consent is inherently a violation of the principle of respect for a person's autonomy. Proponents of organ donation from uncontrolled donation after cardiac death, on the other hand, claim that these nonconsensual interventions enhance respect for autonomy by allowing people, through surrogate decision making, to execute their right to donate organs. However, the lack of transparency and the absence of protection of individual autonomy, for the sake of maximizing procurement opportunities, have placed the current organ-donation system of opting-in in great jeopardy. Equally as important, current policies enabling and enhancing organ procurement practices, pose challenges to the constitutional rights of individuals in a pluralistic society as these policies are founded on flawed medical standards for declaring death. (shrink)

Donating, distributing and ultimately transplantingorgans each has distinct ethical problems. In thispaper I suggest that the first ethical question is notwhat should be done but what is a fair way in whicheach of these problems can be addressed. Experts –whether these be transplant surgeons, policy analysts,political scientists or ethicists – can help guidebut cannot by themselves make such decisions. Inmaking these decisions the difference betweenidentified and non-identified lives is crucial. Isuggest that an approach in which reason is temperedby compassion (``compassionate (...) rationality'') whendealing with identified lives and in whichcompassion is controlled by reason (``rationalcompassion'') in dealing with unidentified lives mustserve us well. Ultimately decisions of this sort areprone to sturdy democratic process which is possibleonly when the preconditions of person, economic andeducational democracy are met. (shrink)

One of the most controversial aspects in uncontrolled donation of organs after circulatory death is the initiation of preservation measures before death. I argue that in so-called opting-out systems only under very stringent conditions we might presume consent to the instauration of those measures. Given its current legal framework, I claim that this is not the case of Spain, a well-known country in which consent is presumed—albeit only formally—and where uDCD is currently practiced.

In his précis, James Stacey Taylor sets out his full-blooded Epicureanism, which concludes that “death is not a harm to the person who dies and that persons can neither be harmed nor wronged by events that occur after their deaths.”1 He then considers various topics in bioethics in the light of his Epicureanism, one of which I consider here: presumed consent in the procurement of organs for transplantation. Although I do not accept Taylor's Epicureanism and although his examination (...) of presumed consent is flawed in various ways, I think we can learn something important from him.Taylor couches the problem in terms of what we are supposed to presume about people's consent or dissent and he thinks that the USA and UK have a system of ‘presumed refusal’ “whereby it is presumed that a person would refuse to have her transplantable organs removed from her postmortem unless she had explicitly indicated otherwise” . Taylor makes a common mistake. The USA and UK have never had such a presumption. In these countries, people who explicitly refuse may not have their organs taken, whereas people who do not explicitly consent may have their organs taken if, roughly speaking, their families consent. Thus non-consenters are not presumed to be refusers.Leaving aside the mistake about the status quo, …. (shrink)

The demand for donor organs for transplantation in the UK far exceeds the supply. A number of improvements in the infrastructure surrounding organ donation, as well as attempts to increase public awareness, have been made over recent years, but there remains a massive shortfall. It has been proposed that a system of presumed consent for organ donation, in which all individuals are considered to be potential organ donors after death unless they have previously opted out, may serve to (...) increase the supply of organs. Recently the Welsh Assembly passed a Bill introducing presumed consent by 2015, but the debates regarding legislative changes are still on-going in England, Scotland and Northern Ireland. The ethical implications of presumed consent legislation are at the centre of these discussions. When examined by a principlist approach, presumed consent may be deemed to be an ethically beneficial measure to increase organ donation rates. It is argued here that the system of presumed consent may actually be more respectful of the principle of autonomy than a system of explicit consent, on the basis that it goes against the wishes of the fewest number of people, and it has clear benefits in terms of beneficence and justice whilst also being compatible with the principle of nonmaleficence. Although there is some debate about the precise impact that presumed consent would have on donation rates, there is evidence to suggest that it would result in an increase in the donor organ supply, when combined with improvements in education and infrastructure. (shrink)

Organ procurement policy from the recently deceased recasts families into gatekeepers of a scarce medical resource. To the frustration of organ procurement teams, families do not always authorize organ donation. As a result, efforts to increase the number of organs available for transplantation often seek to limit the authority of families to refuse organ retrieval. For example, in some locales if a deceased family member has satisfied the legal conditions for first-person prior assent, a much looser and easier standard to (...) satisfy than informed consent, organ retrieval may proceed despite the family’s objections. Some countries have replaced voluntary consent to organ donation with forms of organ conscription. Often referred to under the misnomer “presumed consent,” such policies legalize the harvesting of organs at death, unless individuals exercise official options to opt out. As this article explores, however, there are good grounds for affirming the authority of the family to consent to or to deny organ donation on behalf of recently deceased family members, as well as to reject first-person assent and “presumed consent” policies of organ procurement. Insofar as individuals have failed clearly and competently to provide informed consent to organ donation, moral authorization for the use of the person and his body ought to be grounded on the foundational authority of the family, rather than the state’s supposed interests in obtaining organs for transplantation. (shrink)

The organ donor shortfall in the UK has prompted calls to introduce legislation to allow for presumed consent: if there is no explicit objection to donation of an organ, consent should be presumed. The current debate has not taken in account accepted meanings of presumption in law and science and the consequences for rights of ownership that would arise should presumed consent become law. In addition, arguments revolve around the rights of the competent autonomous (...) adult but do not always consider the more serious implications for children or the disabled. (shrink)

Background Posthumous organ procurement is hindered by the consenting process. Several consenting systems have been proposed. There is limited information on public relative attitudes towards various consenting systems, especially in Middle Eastern/Islamic countries. Methods We surveyed 698 Saudi Adults attending outpatient clinics at a tertiary care hospital. Preference and perception of norm regarding consenting options for posthumous organ donation were explored. Participants ranked (1, most agreeable) the following, randomly-presented, options from 1 to 11: no-organ-donation, presumed consent, informed (...) class='Hi'>consent by donor-only, informed consent by donor-or-surrogate, and mandatory choice; the last three options ± medical or financial incentive. Results Mean(SD) age was 32(9) year, 27% were males, 50% were patients’ companions, 60% had ≥ college education, and 20% and 32%, respectively, knew an organ donor or recipient. Mandated choice was among the top three choices for preference of 54% of respondents, with an overall median[25%,75%] ranking score of 3[2,6], and was preferred over donor-or-surrogate informed consent (4[2,7], p vs. 11[6,11], respectively, p = 0.002). Compared to females, males more perceived donor-or-surrogate informed consent as the norm (3[1,6] vs. 5[3,7], p vs. 8[4,9], p vs. 5[2,7], p Conclusions We conclude that: 1) most respondents were in favor of posthumous organ donation, 2) mandated choice system was the most preferred and presumed consent system was the least preferred, 3) there was no difference between preference and perception of norm in consenting systems ranking, and 4) financial (especially in females) and medical (especially in males) incentives reduced preference. (shrink)

The American Journal of Bioethics, Volume 12, Issue 2, Page 44-46, February 2012.

Erleichtert die Konzeptualisierung der Patientenverfügung als bloßes Indiz für den mutmaßlichen Willen die notwendige Einbeziehung eines relationalen Autonomieverständnisses in eine zunehmend kulturübergreifende Bioethik? Ich lege dar, dass die Berücksichtigung relationaler Autonomiekonzepte kein überzeugendes Argument für die Bestimmung der Patientenverfügung als bloßes Indiz für den mutmaßlichen Willen ist, sondern vielmehr – neben einer Reihe anderer Argumente – für die Patientenverfügung als verbindliche Willensbekundung spricht. Diese erweist sich als flexibel genug, um unterschiedlichen Formen von Autonomie gerecht zu werden.

Erleichtert die Konzeptualisierung der Patientenverfügung als bloßes Indiz für den mutmaßlichen Willen die notwendige Einbeziehung eines relationalen Autonomieverständnisses in eine zunehmend kulturübergreifende Bioethik? Ich lege dar, dass die Berücksichtigung relationaler Autonomiekonzepte kein überzeugendes Argument für die Bestimmung der Patientenverfügung als bloßes Indiz für den mutmaßlichen Willen ist, sondern vielmehr – neben einer Reihe anderer Argumente – für die Patientenverfügung als verbindliche Willensbekundung spricht. Diese erweist sich als flexibel genug, um unterschiedlichen Formen von Autonomie gerecht zu werden.

Opt-out systems of postmortal organ procurement are often referred to as ‘presumed consent’ systems. A presumption directs us, in a case in which no compelling evidence is available to hold that P, nevertheless to proceed as if P were true, unless there is sufficient evidence that it is false. It is recommended to presume consent in this case, because, in the absence of registered objections of the deceased, it is held to be more probable that she consented (...) than that she did not. Whether this suggestion makes sense, however, turns out to depend on the proper interpretation of the concept of ‘consent’. On a mental state conception of consent we are allowed to presume it if we have reason to suppose the deceased to have been in favour of donation. However, we should rather understand consent to be a public action of authorisation. On that view consent cannot be presumed, and the opt-out systems as we presently know them on the European continent and elsewhere do not satisfy the requirement that the deceased should have consented to the removal of his organs. (shrink)

Cet article propose une évaluation éthique des institutions qui organisent la transplantation avec donneurs décédés, au travers du rôle qu’elles accordent à la famille survivante. Son objectif est double. Il s’agit, premièrement, de montrer que la famille possède un pouvoir de décision considérable en matière de prélèvement posthume bien que les législations soient habituellement décrites comme fondées sur le consentement ou l’opposition des personnes concernées. Deuxièmement, il s’agit de montrer que les politiques qui octroient un tel pouvoir aux familles manquent (...) à un devoir d’équité, en négligeant les intérêts à la fois des personnes concernées et des malades en attente de greffe. (shrink)

In this paper I problematise quite a simple assertion: that the two major frameworks used in assessing consent to post-mortem organ donation, presumed consent and informed consent, are procedurally similar in that both are ‘default rules.’ Because of their procedural common characteristic, both rules do exclude marginalized groups from consent schemes. Yet this connection is often overlooked. Contract theory on default rules, better than bioethical arguments, can assist in choosing between these two rules. Applying contract (...) theory to the question of post-mortem organ donation suggests that the default rule should be one that goes against the wishes of the stronger party in consent decisions. (shrink)

We thank Lucy Frith for her thought-provoking response1 to our paper, where we argued that it would be ethically acceptable to contact an anonymous egg donor to help facilitate diagnostic genetic testing for a donor-conceived child.2 While we read Frith’s commentary with interest, we still think that the egg donor should be contacted in the case that we describe. Frith raises concerns as to whether contact would constitute ‘ overriding consent ’, thus ’ potentially set a dangerous precedent ’ (...) for existing gamete donors and donor-conceived children. In contrast, we consider that contacting the egg donor would not override her consent, as her views on contact in the instance that has now arisen were never sought. Our view is that given we do not currently know what she might want, contacting her is a more legitimate way of respecting her autonomy than trying to anticipate her likely answer. We strongly agree with Frith’s suggestion that future consent discussions around gamete donation should make explicit ‘ the possibility of being contacted in the future if there is a relevant reason for doing so ’. Frith expresses a concern that contact would constitute ‘ overriding [the egg donor’s] consent ’, meaning that we have to ‘ justify contacting the egg donor against her previously stated wishes not to be contacted ’. However, our argument is that the egg donor was never asked whether or not she was happy to be contacted in the circumstances that have now arisen. Thus, there is no consent to be overridden, given that she never gave or withheld it in the first place. Frith rightly acknowledges that her arguments therefore ‘ [do] not fully address [our] main worry that the donor’s wishes are essentially unknown, as she was not asked about this specific situation and …. (shrink)

When children are too young to make their ownautonomous decisions, decisions have to be madefor them. In certain contexts we allow parentsand others to make these decisions, and do notinterfere unless the decision clearly violatesthe best interest of the child. In othercontexts we put a priori limits on whatkind of decisions parents can make, and/or whatkinds of considerations they have to take intoaccount. Consent to medical research currentlyfalls into the second group mentioned here. Wewant to consider and ultimately reject (...) one ofthe arguments put forward for putting medicalresearch into the second category. We willargue that some objections to children'sparticipation in research are either based onan implausibly restrictive conception of whatis in fact in the child's best interests orthat there is an implicit and false premisehidden in this argument; i.e., the premise thatour children have so deeply fallen into moralturpitude that we must assume that they wouldnot want to fulfill their moral obligations,or, that they will grow up to be morallydeficient and will then wish not to have actedwell while a child. (shrink)

The ethics of deceased organ procurement (OP) is supposedly based on individual consent to donate, either explicit (opt-in) or presumed (opt-out). However, in many cases, individuals fail to express any preference regarding donation after death. When this happens, the decision to remove or not to remove their organs depends on the policy’s default option or on family preferences. Several studies show that in most countries the family plays a significant and often decisive role in the process of decision-making (...) for OP. Depending on the country, the family may be allowed to take different kinds of actions in different situations, and this may be granted either by law or by clinical practice only. This adds much complexity to the usual classification of consent policies in two categories: opt-in and opt-out. Here we propose a novel and comprehensive taxonomy of the models of consent for OP according to three variables: (1) the deceased’s wishes, if any, (2) family wishes, if any, and (3) default policies. By analysing these models of consent, we show that they rely on at least three different concepts of autonomy: individual autonomy, relational autonomy, and family autonomy. In light of this analysis, we discuss the ethical debates surrounding two policy approaches: presumed consent and family veto. (shrink)

One way of increasing the supply of organs available for transplant would be to switch to an opt-out system of donor registration. This is typically assumed to operate on the basis of presumed consent, but this faces the objection that not all of those who fail to opt out would actually consent to the use of their cadaveric organs. This paper defuses this objection, arguing that people's actual, explicit or implicit, consent to use their organs is (...) not needed. It borrows David Estlund's notion of ‘normative consent’ from the justification of political authority and applies it to the case of organ donation. According to this idea, when it is wrong to withhold consent to something, the moral force of that lack of consent may be null and void. If it is wrong of a person to refuse to donate their cadaveric organs to others, then it may be that their actual consent is not needed. This supports an opt-out system, which provides protection for those who have genuine reasons to refuse donation, and spares the worries as to what the deceased would actually have wanted. (shrink)

Therapeutic misconception involves the failure of subjects either to understand or to incorporate into their own expectations the distinctions in nature and purpose of personally responsive therapeutic care, and the generic relationship between subject and investigator which is constrained by research protocols. Researchers cannot disregard this phenomenon if they are to ensure that subjects engage in research on the basis of genuine informed consent. However, our presumption of patient autonomy must be sustained unless we have compelling evidence of serious (...) misunderstanding. This article argues that the mere expression of aspects of therapeutic misconception should not necessarily displace the presumption of subject autonomy or undermine ethical inclusion in research for at least three reasons. First, some interpretations of the empirical data do not suggest misunderstanding. Second, assessment of misestimation and optimism are delicate and value-laden, and turn quickly from questions of autonomy to questions of judgment. Third, incomplete understanding may yet be sufficient to allow a subject to engage in a substantially autonomous decision-making process. Our point is not to dismiss the possibility of genuine therapeutic misconception, but to question its frequency and fatality to the consent process. (shrink)

Background Genetic databases are becoming increasingly common as a means of determining the relationship between lifestyle, environmental exposures and genetic diseases. These databases rely on large numbers of research subjects contributing their genetic material to successfully explore the genetic basis of disease. However, as all possible research questions that can be posed of the data are unknown, an unresolved ethical issue is the status of informed consent for future research uses of genetic material. Discussion In this paper, we discuss (...) the difficulties of an informed consent model for future ineffable uses of genetic data. We argue that variations on consent, such as presumed consent, blanket consent or constructed consent fail to meet the standards required by current informed consent doctrine and are distortions of the original concept. In this paper, we propose the concept of an authorization model whereby participants in genetic data banks are able to exercise a certain amount of control over future uses of genetic data. We argue this preserves the autonomy of individuals at the same time as allowing them to give permission and discretion to researchers for certain types of research. Summary The authorization model represents a step forward in the debate about informed consent in genetic databases. The move towards an authorization model would require changes in the regulatory and legislative environments. Additionally, empirical support of the utility and acceptability of authorization is required. (shrink)

ABSTRACT A major moral problem in relation to the deCODE genetics database project in Iceland is that the heavy emphasis placed on technical security of healthcare information has precluded discussion about the issue of consent for participation in the database. On the other hand, critics who have emphasised the issue of consent have most often demanded that informed consent for participation in research be obtained. While I think that individual consent is of major significance, I argue (...) that this demand for informed consent is neither suitable nor desirable in this case. I distinguish between three aspects of the database and show that different types of consent are appropriate for each. In particular, I describe the idea of a written authorisation based on general information about the database as an alternative to informed consent and presumed consent in database research. (shrink)

Opt-out systems of postmortem organ procurement are often supposed to be justifiable by presumed consent, but this justification turns out to depend on a mistaken mental state conception of consent. A promising alternative justification appeals to the analogical situation that occurs when an emergency decision has to be made about medical treatment for a patient who is unable to give or withhold his consent. In such cases, the decision should be made in the best interests of (...) the patient. The analogous suggestion to be considered, then, is, if the potential donor has not registered either his willingness or his refusal to donate, the probabilities that he would or would not have preferred the removal of his organs need to be weighed. And in some actual cases the probability of the first alternative may be greater. This article considers whether the analogy to which this argument appeals is cogent, and concludes that there are important differences between the emergency and the organ removal cases, both as regards the nature of the interests involved and the nature of the right not to be treated without one’s consent. Rather, if opt-out systems are to be justified, the needs of patients with organ failure and/or the possibility of tacit consent should be considered. (shrink)

ABSTRACT A major moral problem in relation to the deCODE genetics database project in Iceland is that the heavy emphasis placed on technical security of healthcare information has precluded discussion about the issue of consent for participation in the database. On the other hand, critics who have emphasised the issue of consent have most often demanded that informed consent for participation in research be obtained. While I think that individual consent is of major significance, I argue (...) that this demand for informed consent is neither suitable nor desirable in this case. I distinguish between three aspects of the database and show that different types of consent are appropriate for each. In particular, I describe the idea of a written authorisation based on general information about the database as an alternative to informed consent and presumed consent in database research. (shrink)

The debate over whether germ-line genetic engineering is justified on the basis of the consent or presumed consent of future generations is mired in philosophical confusion. Because of this, the principle of informed consent fails to provide a reason to restrict germ-line genetic engineering. Most recent bioethicists ground the consent requirement on individual autonomy. While conceptually coherent, the notion of individual autonomy also fails to provide a reason for prohibiting germ-line genetic engineering. Moreover, it offers (...) little in the way of useful guidance for regulating genetic engineering. I argue, however, that respect for autonomy in the sense of moral agency – the ability to reflect on moral considerations and conform one’s behavior to those reflections – provides a principle that can be used for a nuanced evaluation of proposals for genetic engineering. (shrink)

As the debate over an English opt-out policy for organ procurement intensifies, assessing existing experiences becomes even more important. The Welsh introduction of opt-out legislation provides one important point of reference. With the introduction of deemed consent in December 2015, Wales became the first part of the UK to introduce an opt-out system in organ procurement. My article ‘Deemed consent: assessing the new opt-out approach to organ procurement in Wales’ conducted an early assessment of this.1 Taking its starting (...) point in important concerns often raised in discussion over opt-out legislation, it identified four key parameters to assess the effects. These are living donor rates, deceased donor rates, donor registrations and family refusals. My article compares these indicators before and after the enactment of the Welsh legislation employing a different-in-different design. In his reply to my article ‘Deemed consent: assessing the new opt-out approach to organ procurement in Wales’, Jordan Alexander Parsons offers two interesting critiques. The first pertains to the choice of indicators. Parsons prefer a narrower focus on the effect on deceased donor rates. The second pertains to the choice of data, Parsons preferring a time series of Wales to my different-in-different design. Parsons refers mainly to the official Welsh evaluation,2 a report I also cited in supplement to the NHS Activity Report data I employed. …. (shrink)

Some opponents of reproductive human cloning have argued that, because of its experimental nature, any attempt to create a child by way of cloning would risk serious birth defects or genetic abnormalities and would therefore be immoral. Some versions of this argument appeal to the consent of the person to be conceived in this way. In particular, they assume that if an experimental reproductive technology has not yet been shown to be safe, then, before we use it, we are (...) morally obligated to get either the actual consent or the presumed consent of the person to be conceived. In this article, I attempt to explain the appeal of such consent-based arguments as deriving from a mistaken view of personal identity. I then argue that since this view is false, such arguments are unsound. Finally, I argue that even if reproductive cloning is unsafe, it may still be morally permissible in some circumstances. (shrink)

This issue considers the ethics of a healthcare provider intervening into a patient’s genitalia, whether by means of cutting or surgery or by ‘mere’ touching/examination. Authors argue that the permissibility of such actions in the absence of a relevant medical emergency does not primarily turn on third-party judgments of expected levels of physical harm versus benefit, or on related notions such as extensiveness or invasiveness; rather, it turns on the patient’s own consent. To bolster this argument, attention is drawn (...) to the status of the genitals as ‘intimate’ anatomy—a status that is not fully erased by being in a medical context. In this editorial, we draw on the work of Talia Mae Bettcher on ‘intimate agency’ to explore why unconsented interventions into the genitalia may constitute a distinctive sort of personal violation compared to unconsented contact with various other parts of the human body. In their feature article, Marit van der Pijl and colleagues1 argue it is unethical for healthcare providers to perform unconsented episiotomies on persons in labour. In particular, they suggest that, outside of certain rare emergencies in which, for example, the person giving birth is incapacitated1 and the procedure cannot be delayed until consent becomes possible without introducing a significant risk of serious harm (call these ‘medically necessary’2 procedures), ‘presumed consent’ is the incorrect standard to apply. Instead, they stress that, especially when a proposed intervention involves a person’s genital, sexual or reproductive organs, the need to obtain their explicit consent in advance of proceeding must be honoured. As the authors note, the broader social significance of our genitalia—widely regarded as ‘private’ anatomy—is not erased by being in a medical context (see also 2–4). Boundaries must still be observed. Ethically, this ‘leaves a very small margin for error because invasion of these body parts …. (shrink)

There are few moral principles less controversial than “don’t touch people’s private parts without consent.” Though the principle doesn’t make explicit that there are exceptions, there clearly are some. Parents must wipe their infants. If an unconscious patient is admitted to the emergency room with a profusely bleeding laceration on their genitals, a doctor must give them stitches. The researchers who proposed the study in question, which would look for a connection between burn patients’ microbiomes and their clinical outcomes, (...) presumably believed they had identified an additional exception to the aforementioned principle. I argue that they did not. Rather, because of their tremendous inherent risks, we ought only to perform intimate procedures on those who can’t consent when the procedure is for their own good. -/- Intimate violations have been overlooked in both philosophy and medicine. Because of this, we have lacked an adequate conceptual framework for identifying certain kinds of harms research can inflict. When we understand these special risks, we see that the IRB was right to deny a waiver of consent. (shrink)