Educational pelvic exams on anesthetized women: Why consent matters

It is argued here that the practice of medical students performing pelvic exams on women who are under anesthetic and have not consented is immoral and indefensible. This argument begins by laying out the ethical justification for the practice of informed consent, which can be found in autonomy and basic rights. Foregoing the process of consent within medicine can result in violations of both autonomy and basic rights, as well as trust, forming the basis of the wrong of unauthorized pelvic examinations. Several objections to this argument are considered, all of which stem from the idea that this practice constitutes an exception to the general requirement of informed consent. These objections suggest that nonconsensual pelvic examinations on women under anesthetic are ethically acceptable on utilitarian grounds, in that they offer benefits either to the patient or to society, or on the grounds of triviality, in that consent is already presumed, or the practice is insignificant. Each of these objections is rejected and the practice is deemed indefensible.     

The Ethics of Elective (Non-Therapeutic) Ventilation

Elective ventilation (EV) is ventilation applied, not in the interest of patients, but in order to secure transplantable organs. It carries with it a small risk that patients who would otherwise have died will survive in a persistent vegetative state. Is EV ever justifiable? We argue: (1) The only thing which can justify exposing patients to risk not taken for their benefit is their consent, and we cannot rely on implied consent or third party consent in the case of EV. Thus, absent explicit consent of patients, EV is not justifiable. (2) It is not clear that explicit consent should be sought, or where it is offered honoured, given the potential EV has for deterring organ donors and causing stress to staff and families.     

Ethical problems with the mental health evaluation standards of care for adult gender variant prospective patients

The World Professional Association for Transgender Health's "Standards of Care: The Hormonal and Surgical Sex Reassignment of Gender Dysphoric Persons" (SOC) set forth standards clinicians must meet to ensure ethical care of adequate quality. The SOC also set requirements gender variant prospective patients must meet to receive medical interventions to change their sexual characteristics to those more typical for the sex to which they were not assigned at birth. One such requirement is that mental health professionals must ascertain that prospective patients have met the SOC's eligibility and readiness criteria. This article raises two objections to this requirement: ethically obligatory considerations of the overall balance of potential harms and benefits tell against it, and it violates the principle of respect for autonomy. This requirement treats gender variant prospective patients who request medical intervention as different in kind, not merely degree, from other patient populations, as it constructs the very request as a phenomenon of incapacity. This is ethically indefensible in and of itself, but it is especially pernicious in a sociocultural and political context that already denies gender variant people full moral status.     

In vitro gametogenesis: The end of egg donation?

This paper explores whether egg donation could still be ethically justified if in vitro gametogenesis (IVG) became reliable and safe. In order to do this, issues and concerns that might inform a patient’s reasoning in choosing to use donor eggs instead of IVG are explored and assessed. It is concluded that egg donation would only be ethically justified in a narrow range of special cases given the (hypothetical) availability of IVG treatment and, further, that egg donation could itself be replaced by donation through IVG techniques. Two possible criticisms of this position are then considered: Ones based on respect for patient wishes, and on loss of donor benefit. It is concluded that whilst neither argument constitutes a strong enough reason to continue with programmes of egg donation, egg‐sharing programmes could still be permitted come the advent of IVG; these could then provide a morally acceptable source of “natural” donor eggs.     

Female genital mutilation and cosmetic surgery: regulating non-therapeutic body modification

In the UK, female genital mutilation is unlawful, not only when performed on minors, but also when performed on adult women. The aim of our paper is to examine several arguments which have been advanced in support of this ban and to assess whether they are sufficient to justify banning female genital mutilation for competent, consenting women. We proceed by comparing female genital mutilation, which is banned, with cosmetic surgery, towards which the law has taken a very permissive stance. We then examine the main arguments for the prohibition of the former, assessing in each case both (a) whether the argument succeeds in justifying the ban and, if so, (b) whether a parallel argument would not also support a ban on the latter. We focus on the following arguments. Female genital mutilation should be unlawful because: (1) no woman could validly consent to it; (2) it is an oppressive and sexist practice; (3) it involves the intentional infliction of injury; (4) it causes offence. Our view is that arguments (3) and (4) are unsound and that, although arguments (1) and (2) may be sound, they support not only a ban on female genital mutilation, but also one on (some types of) cosmetic surgery. Hence, we conclude that the present legal situation in the UK is ethically unsustainable in one of the following ways. Either the ban on female genital mutilation is unjustified because arguments (1) and (2) are not in fact successful; or the law's permissive attitude towards cosmetic surgery is unjustified because arguments (1) and (2) are in fact successful and apply equally to female genital mutilation and (certain forms of) cosmetic surgery. The people of the countries where female genital mutilation is practised resent references to 'barbaric practices imposed on women by male-dominated primitive societies', especially when they look at the Western world and see women undergoing their own feminization rites intended to increase sexual desirability: medically dangerous forms of cosmetic plastic surgery, for instance....     

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.     

Factors associated with consent for organ donation: a retrospective population-based study

Background:Optimizing the approach to and consent of potential organ donors maximizes patient autonomy and the availability of organs for transplants. We set out to identify modifiable factors associated with donation consent.Methods:We conducted a retrospective cohort study of consecutive adults (≥ 18 yr) referred for organ donation in Ontario between April 2013 and June 2019. We analyzed patient clinical data and demographics, data on substitute decision-makers and characteristics of the donation consent approach. Study outcomes were consent for organ donation and approach rate. We evaluated independent associations between consent and approach-and system-level factors.Results:We identified 34 837 referrals for organ donation, of which 6548 (18.8%) substitute decision-makers were approached for consent. Of these, 3927 (60.0% of approaches) consented for organ donation and 1883 (48.0% of consents) patients proceeded to be organ donors. The most common reason substitute decision-makers were not approached for consent in a case with donation potential was a late referral by the health care team (45.2%). Modifiable factors independently associated with consent included a telephone approach for consent (adjusted odds ratio [OR] 0.46, 95% confidence interval [CI] 0.35–0.58) and a collaborative approach by a physician and donation coordinator (adjusted OR 1.26, 95% CI 1.01–1.59).Interpretation:Consent for organ donation was associated with several modifiable factors. Organizations should target interventions to ensure timely referrals to organ donation organizations, increase in-person consent approaches and increase physician participation in the approach process.

Many people die on transplant waiting lists because the demand for organs outstrips supply. Almost 4500 people are on organ transplant waiting lists in Canada. Despite public support for organ donation across Canada,¹ donation rates vary between 8.8 and 21.2 donors per million population, ² and a substantial pool of potential donors is not being realized. ^2,3 The identification, referral and approach of potential donors can be facilitated by policy, legislation and best practices, ^3,4 although the efficacy of interventions is variable across jurisdictions.^5,6 Some comprehensive interventions to increase donor numbers have not changed consent rates,⁷ suggesting that the consent approach process may be a target for improvement.Substitute decision-makers play an important role in the organ donation process, even in jurisdictions with donation consent registries or opt-out consent systems. Substitute decision-makers are almost always asked permission for organ donation, even when there is a registered donation consent,⁸ and their consent rates vary widely.⁹ Substitute decision-makers faced with consent decisions often do so in emotionally charged circumstances, and many do not know the explicit wishes of the patient.¹⁰ Given this context, the process of obtaining consent and the supports provided may have a substantial impact on the decision. Practices have been identified that improve consent rates from substitute decision-makers,¹¹ and these are routinely performed by large, high-performing organ donation organizations. Several epidemiological studies have identified nonmodifiable factors associated with donation consent (e.g., race, age, socioeconomic status and education).^12–15 The persistent variability in consent rates suggests that other modifiable factors may influence a substitute decision-maker’s decision to consent.We aimed to identify modifiable approach-and system-level factors that were associated with positive consent for organ donation in Ontario, Canada.     

IS THE ADOPTION OF MORE EFFICIENT STRATEGIES OF ORGAN PROCUREMENT THE ANSWER TO PERSISTENT ORGAN SHORTAGE IN TRANSPLANTATION?

[I]s persistent organ shortage the major obstacle to the performance of more procedures as often popularly portrayed? Does the answer therefore lie in the adoption of more efficient strategies of organ procurement? While the measures taken to improve the efficiency of organ procurement may be inspired by the laudable motive of saving lives, they may ultimately prove to be myopic if the larger ethical issues raised by organ transplant programs for the allocation of national and organ resources are not given their due consideration. For any society that desires to include organ transplantation in its health delivery system, it must consider the social and ethical issues that transplant programs raise for the macroallocation of available national resources and the manner by which organ resources are procured, and distributed. The failure to resolve these issues in an ethically acceptable manner at any of these levels would render any transplant program ethically indefensible. This essay therefore argues that before a society decides on its policy of organ procurement it ought to make prior assessments of: a) its social priorities; b) the policies for ensuring fair access to organ resources; and c) the extent to which it is willing to support transplants.     

Opt‐in or opt‐out to increase organ donation in South Africa? Appraising proposed strategies using an empirical ethics analysis

Utilising empirical ethics analysis, we evaluate the merits of systems proposed to increase deceased organ donation in South Africa (SA). We conclude that SA should maintain its soft opt‐in policy, and enhance it with ‘required transplant referral’ in order to maximise donor numbers within an ethically and legally acceptable framework. In SA, as is the case worldwide, the demand for donor organs far exceeds the supply thereof. Currently utilising a soft opt‐in system, SA faces the challenge of how to increase donor numbers in a context which is imbued with inequalities in access to healthcare, multiplicitous personal beliefs and practices, distrust of organ transplant and varying levels of education and health literacy. We argue that a hard opt‐in, opt‐out or mandated consent system would be problematic, and we present empirical data from Gauteng Province illustrating barriers to ethically sound practice in soft consent systems. Ultimately, we argue that in spite of some limitations, a soft opt‐in system is most realistic for SA because its implementation does not require extensive public education campaigns at national level, and it does not threaten to further erode trust at a clinical level. However, to circumvent some of the clinical‐level barriers identified in our empirical study, we propose a contextually sensitive option for “enabling” soft opt‐in through “required transplant referral”. We argue that this system is legally defensible, enhances ethical practice and could also increase donor numbers as it has in many other countries.     

A direct advance on advance directives

Advance directives (ADs), which are also sometimes referred to as 'living wills', are statements made by a person that indicate what treatment she should not be given in the event that she is not competent to consent or refuse at the future moment in question. As such, ADs provide a way for patients to make decisions in advance about what treatments they do not want to receive, without doctors having to find proxy decision-makers or having recourse to the doctrine of necessity. While patients can request particular treatments in an AD, only refusals are binding. This paper will examine whether ADs safeguard the autonomy and best interests of the incompetent patient, and whether legislating for the use of ADs is justified, using the specific context of the legal situation in the United Kingdom to illustrate the debate. The issue of whether the law should permit ADs is itself dependent on the issue of whether ADs are ethically justified; thus we must answer a normative question in order to answer the legislative one. It emerges that ADs suffer from two major problems, one related to autonomy and one to consent. First, ADs' emphasis on precedent autonomy effectively sentences some people who want to live to death. Second, many ADs might not meet the standard criteria for informed refusal of treatment, because they fail on the crucial criterion of sufficient information. Ultimately, it transpires that ADs are typically only appropriate for patients who temporarily lose physical or mental capacity.     

Trust and the Duty of Organ Donation

Several recent publications in biomedical ethics argue that organ donation is generally morally obligatory and failure to do so is morally indefensible. Arguments for this moral conclusion tend to be of two kinds: arguments from fairness and arguments from easy rescue. While I agree that many of us have a duty to donate, in this article I criticize these arguments for a general duty of organ donation and their application to organ procurement policy. My concern is that these arguments neglect the role that trust plays in contemporary organ transplant policies and in differential rational attitudes toward donation. Recognizing donation as an achievement of trust, and acknowledging the warrant of many people's rational distrust or withheld trust in medicine, I argue, should have significant implications for the ethics of organ procurement.     

Organ Donation in Switzerland - An Analysis of Factors Associated with Consent Rate

Background and Aim

Switzerland has a low post mortem organ donation rate. Here we examine variables that are associated with the consent of the deceased’s next of kin (NOK) for organ donation, which is a prerequisite for donation in Switzerland.

Methods and Analysis

During one year, we registered information from NOK of all deceased patients in Swiss intensive care units, who were approached for consent to organ donation. We collected data on patient demographics, characteristics of NOK, factors related to the request process and to the clinical setting. We analyzed the association of collected predictors with consent rate using univariable logistic regression models; predictors with p-values <0.2 were selected for a multivariable logistic regression.

Results

Of 266 NOK approached for consent, consent was given in 137 (51.5%) cases. In multivariable analysis, we found associations of consent rates with Swiss nationality (OR 3.09, 95% CI: 1.46–6.54) and German language area (OR 0.31, 95% CI: 0.14–0.73). Consent rates tended to be higher if a parent was present during the request (OR 1.76, 95% CI: 0.93–3.33) and if the request was done before brain death was formally declared (OR 1.87, 95% CI: 0.90–3.87).

Conclusion

Establishing an atmosphere of trust between the medical staff putting forward a request and the NOK, allowing sufficient time for the NOK to consider donation, and respecting personal values and cultural differences, could be of importance for increasing donation rates. Additional measures are needed to address the pronounced differences in consent rates between language regions.     

Experiences and attitudes towards end-of-life decisions amongst Danish physicians

In this survey we have investigated the experiences and attitudes of Danish physicians regarding end-of-life decisions. Most respondents have made decisions that involve hastening the death of a patient, and almost all find it acceptable to do so. Such decisions are made more often, and considered ethically more acceptable, with the informed consent of the patient than without. But both non-resuscitation decisions, and decisions to provide pain relief in doses that will shorten the patient's life, have been made and found acceptable by at least 50% of the respondents, even when there is no informed consent. Furthermore, 12% have doubled morphine dosages with fixed intervals, thus providing doses substantially higher than that necessary to control pain, without the informed consent of the patient. Two per cent have helped in assisted suicide, and 5% have administered a lethal injection at the patient's request. Respectively 37% and 34% find these last two practices ethically acceptable. Amongst those that do not find them acceptable, the most important reasons to be opposed are, the doctrine of double effect, the doctrine of doing and allowing, and the view that human life is sacred. Amongst supporters, the most important reasons mentioned are, that the patient's right to self-determination should be respected, the view that a patient should not be forced to suffer, and the view that the patient has a right to be helped to a dignified death.     

Consenting to donation: an examination of current practices in informed consent for tissue donation in the US

Informed consent is the primary moral principle guiding the donation of human tissue for transplant purposes. When patients’ donation wishes are not known, family members making the decision about tissue donation should be provided with requisite information needed to make informed donation decisions. Using a unique dataset of 1,016 audiotaped requests for tissue obtained from 15 US tissue banking organizations, we examined whether the information provided to families considering tissue donation met current standards for informed consent. The results indicated that many elements of informed consent were missing from the donation discussions, including the timeframe for procurement, autopsy issues, the involvement of both for-profit and nonprofit organizations, and the processing, storage and distribution of donated tissue. A multiple linear regression analysis also revealed that nonwhites and family members of increased age received less information regarding tissue donation than did younger, white decision makers. Recommendations for improving the practice of obtaining consent to tissue donation are provided.     

The ethics of biobanking: Assessing the right to control problem for broad consent

The biobank consent debate is one with deeply held convictions on both the ‘broad’ and ‘specific’ side with little sign of resolution. Recently, Thomas Ploug and Soren Holm have developed an alternative to both specific and broad consent: a meta‐consent framework. The aim here is to consider whether meta‐consent provides a ‘solution’ to the biobank consent debate. We clarify what ‘meta‐consent’ actually is (arguing that the label is a misnomer and ‘consent à la carte’ is more accurate). We identify problems with Ploug and Holm's arguments, and some challenges for meta‐consent. We focus on whether there is any ethical obligation to provide consent à la carte. There may seem to be so, especially if we draw upon an unclear appeal to the ethical significance of ‘respect for autonomy’. Similarly, there might seem to be an intuitive inference from the fact that ethically legitimate research requires informed consent to the conclusion that it thereby requires consent à la carte. It is shown that this line of inference is mistaken.     

Informed Consent and Genetic Information

In the last 25 years writing in bioethics, particularly in medical ethics, has generally claimed that action is ethically acceptable only if it receives informed consent from those affected. However, informed consent provides only limited justification, and may provide even less as new information technologies are used to store and handle personal data, including personal genetic data. The central philosophical weakness of relying on informed consent procedures for ethical justification is that consent is a propositional attitude, so referentially opaque: consent is given to specific propositions describing limited aspects of a situation, and does not transfer even to closely related propositions. Assembling genetic data in databases creates additional difficulties for ethical justification. This is not because genetic information is intrinsically exceptional, but because the merger of genetic and information technologies make it possible to assemble massive quantities of complex information that defeat individuals' best efforts to grasp what is at stake, or to give or withhold informed consent. The future agenda for bioethics will need to take account of both these limitations of appeals to informed consent.     

The student and the ovum: The lack of autonomy and informed consent in trading genes for tuition

Rising tuition costs have forced university students to become creative in finding ways to fund their education. Some female university students have decided that ova donation may be an acceptable alternative in which to pay for their tuition. This alternative presents itself because of the insufficient number of ova available for assisted reproduction and emerging stem cell technologies. Young female university students are encouraged by Internet sources and respectable electronic and print media to donate their ova in the cause of assisted reproduction for monetary compensation. While university students generally exhibit autonomy, the constraining influence of their financial predicament compromises the elements of informed consent (voluntariness, competence, capacity, understanding, and disclosure) as to their making an autonomous decision in regard to egg donation. Thus, any moral possibility of giving informed consent is negated. Informed consent can only occur through autonomy. A female university student in need of financial resources to pay for her education cannot make an autonomous choice to trade her genes for tuition. Donated ova are not only needed for assisted reproduction, but for stem cell technologies. While the long-term health of women who donate their ova is of concern (a potential risk of cancer after long term use of ovulation induction), of equal concern is the possibility of a growth in the trade of ova targeting third world and Eastern European women where the precedence for autonomy and informed consent is not well established.     

Charitable State-Controlled Foundation Human Tissue and Cell Research: Ethic and Legal Aspects in the Supply of Surgically Removed Human Tissue For Research in the Academic and Commercial Sector in Germany

Tissue engineering using human cells and tissue has one of the greatest scientific and economical potential in the coming years. There are public concerns during the ongoing discussion about future trends in life sciences and if ethic boundaries might be respected sufficiently in the course of striving for industrial profit and scientific knowledge. Until now, the legal situation of using human tissue material for research is not clear. Accordingly, transparency of action and patients' information are a central component when handling patient material inside and outside of the patient-specific treatment. Whereas in the field of therapeutic use of tissue (e.g. transplantation) there is an emergency situation by the shortage of organs with the risk of the premature death of the potential recipient, this cannot be claimed for tissue donation for research. The basis of every surgical operation is the treatment contract, which places the doctor under obligation to the careful exercise of medical treatment containing the patient's informed consent. This contract only covers the treatment that is intended to cure the patient and the medical measures that are necessary therefor. The further scientific use of body-substances, which are discarded after an operation, are not included. Therefore a personal and independent written enlightenment of the patient and a declaration of informed consent is necessary. Examples of guidelines for tissue supply, Patients information and consent were worked out by theologists, lawyers, scientists and physicians reflecting their practical experience in transplant surgery and liver cell research. As a consequence to cover the ethical and legal aspect of tissue donation in Germany a charitable state-controlled foundation Human Tissue and Cell Research (HTCR) was introduced and established.     

The Consequences of Vagueness in Consent to Organ Donation

In this article I argue that vagueness concerning consent to post‐mortem organ donation causes considerable harm in several ways. First, the information provided to most people registering as organ donors is very vague in terms of what is actually involved in donation. Second, the vagueness regarding consent to donation increases the distress of families of patients who are potential organ donors, both during and following the discussion about donation. Third, vagueness also increases the chances that the patient's intention to donate will not be fulfilled due to the family's distress. Fourth, the consequent reduction in the number of donated organs leads to avoidable deaths and increased suffering among potential recipients, and distresses them and their families. There are three strategies which could be used to reduce the harmful effects of this vagueness. First, recategorizing the reasons (commonly referred to as ‘overrules’ under the current system) given by families who refuse donation from registered donors would bring greater clarity to donation discussions. Second, people who wish to donate their organs should be encouraged to discuss their wishes in detail with their families, and to consider recording their wishes in other ways. Finally, the consent system for organ donation could be made more detailed, ensuring both that more information is provided to potential donors and that they have more flexibility in how their intentions are indicated; this last strategy, however, could have the disadvantage of discouraging some potential donors from registering.     

A multimedia tool for the informed consent of patients prior to gastric banding

Objective: Severe obesity is a clear indication for appropriate, effective weight loss therapy. One option is operative intervention, e.g., gastric banding. Risks of the operation and therapeutic alternatives need to be comprehensibly presented to the patient. The literature has shown that better informed consent is obtained using information presented in a multimedia/video‐based format. The current study developed and evaluated a multimedia program aimed at obtaining informed consent from obese patients before gastric banding. Research Methods and Procedure: An interactive multimedia program was developed with information about preoperative examinations, the operation itself, hospital stay, operative risks, alternative therapies, and the pathophysiology and health risks of obesity. Two groups (Group 1, n = 20, mean age 38 years, informed consent attained with conventional document information; Group 2, n = 20, mean age 37 years, informed consent attained with additional multimedia information) were interviewed regarding comprehensibility of the information presented, personal satisfaction, and anxiety levels during the informed consent process. Results: Group 2 showed significantly better (p < 0.05) understanding of the presented information and higher levels of satisfaction with the informed consent process. Anxiety levels did not significantly differ between the two groups. Discussion: Because patient satisfaction with the informed consent process and understanding of the presented information significantly improved, the multimedia program clearly benefits both surgeons and patients. Personal contact from the surgeon remains essential. High volumes of information presented in multimedia format do not alleviate patient anxiety, and personal contact may be beneficial.