Journal of Medical Ethics

Consent and the opt-out scheme of organ donation

This journal has a long tradition of promoting reasoned debate on key questions in medical ethics. In this and future issues, we hope to continue this tradition by introducing a new type of article. Feature articles will provide a longer, in-depth discussion of an original ethical idea or argument, or of an important empirical finding. These articles will be accompanied by several short commentaries by leading experts in the area who will offer their critical perspective on the article, followed by a brief reply by the author.

Our first such debate is a lively exchange on organ donation. In his feature article, Ben Saunders offers a new argument for an ‘opt-out’ scheme for organ procurement (see page 69, Editor's choice). The idea of an opt-out scheme has of course been defended before. But Saunders claims that the common understanding...

This paper defends an ‘opt-out’ scheme for organ procurement, by distinguishing this system from ‘presumed consent’ (which the author regards as an erroneous justification of it). It, first, stresses the moral importance of increasing the supply of organs and argues that making donation easier need not conflict with altruism. It then goes on to explore one way that donation can be increased, namely by adopting an opt-out system, in which cadaveric organs are used unless the deceased (or their family) registered an objection. Such policies are often labelled ‘presumed consent’, but it is argued that critics are right to be sceptical of this idea—consent is shown to be an action, rather than a mental attitude, and thus not something that can be presumed. Either someone has consented or they have not, whatever their attitude to the use of their organs. Thankfully, an opt-out scheme need not rest on the presumption of consent. Actual consent can be given implicitly, by one's actions, so it is argued that the failure to register an objection (given certain background conditions) should itself be taken as sign of consent. Therefore, it is permissible to use the organs of someone who did not opt out, because they have—by their silence—actually consented.

In his latest defence of opt-out organ donation, Ben Saunders argues that opt-out does not depend on presuming consent but instead entails a donor tacitly consenting to making her organs available for transplantation.1 Consent is implied, not merely presumed, in the absence of a registered objection because consent is always an act—a purposeful action or inaction—not a mental attitude of approval.

Saunders' argument hinges on a strong interpretation of consent as a performative utterance in which the act is sufficient and the mental attitude is unnecessary. Once social conventions have established which (in)action constitutes consent, Saunders argues, a person who has performed the relevant act—whether expressly or tacitly—incurs the obligations pursuant to giving her consent. The fact that she may have performed this act without intending to consent is immaterial. This last point seems to take us a step too far. Instead of insisting that an act...

There is much to agree with in Ben Saunders' article.1 He is right to say that presumed consent is only one, shaky, justification for opt-out organ retrieval. I believe he is also right that the value of altruism is of relatively little importance in morally assessing organ procurement schemes.2 But I am not so sure about his opt-out proposal.

Saunders would, I think, describe his proposal as an improvement on the existing system in that it would increase the supply of organs while still securing adequate consent. (I should add that he does not, however, explicitly claim that the supply would increase.) This description invites two questions: (1) would the consent be adequate? and (2) would the supply of organs increase? Before saying a few things in answer to these questions, I want to make what I think is the most important point in trying...

In this reply to Wilkinson and De Wispelaere, I argue that an opt-out donation system can be regarded as tacit consent. I first separate the opt-in/opt-out issue from that of the role that the family ought to play. I then argue that what De Wispelaere calls minimal approval-tracking is not obviously necessary and that, even if it were, opt-out schemes can satisfy this requirement.

Background

Although medical ethicists and educators emphasise patient-centred decision-making, previous studies suggest that patients often prefer their doctors to make the clinical decisions.

Objective

To examine the associations between a preference for physician-directed decision-making and patient health status and sociodemographic characteristics.

Methods

Sociodemographic and clinical information from all consenting general internal medicine patients at the University of Chicago Medical Center were examined. The primary objectives were to (1) assess the extent to which patients prefer an active role in clinical decision-making, and (2) determine whether religious service attendance, the importance of religion, self-rated spirituality, Charlson Comorbidity Index, self-reported health, Vulnerable Elder Score and several demographic characteristics were associated with these preferences.

Results

Data were collected from 8308 of 11 620 possible participants. Ninety-seven per cent of respondents wanted doctors to offer them choices and to consider their opinions. However, two out of three (67%) preferred to leave medical decisions to the doctor. In multiple regression analyses, preferring to leave decisions to the doctor was associated with older age (per year, OR=1.019, 95% CI 1.003 to 1.036) and frequently attending religious services (OR=1.5, 95% CI 1.1 to 2.1, compared with never), and it was inversely associated with female sex (OR=0.6, 95% CI 0.5 to 0.8), university education (OR=0.6, 95% CI 0.4 to 0.9, compared with no high school diploma) and poor health (OR=0.6, 95% CI 0.3 to 0.9).

Conclusions

Almost all patients want doctors to offer them choices and to consider their opinions, but most prefer to leave medical decisions to the doctor. Patients who are male, less educated, more religious and healthier are more likely to want to leave decisions to their doctors, but effects are small.

To meet all physicians' needs for ethics consultation in Finland, a novel form of service, the Physicians' Ethics Forum, was founded in 2003. The Forum is a cost-efficient service based on electronic communication. In this paper, experiences throughout its first 6 years are described.

General practitioners (GPs) have to negotiate a range of challenges when they suspect child abuse or neglect. This article details findings from a Delphi exercise that was part of a larger study exploring the conflicts of interest that arise for UK GPs in safeguarding children. The specific objectives of the Delphi exercise were to understand how these conflicts of interest are seen from the perspectives of an expert panel, and to identify best practice for GPs. The Delphi exercise involved four iterative rounds with questionnaires completed by an expert panel. Results from each round were distilled and findings sent to panel members until consensus was reached. Panel members shared insights regarding their understanding of conflicts of interest in relation to GPs and safeguarding children and responses when conflicts of interests arise. Findings suggested a broader understanding of conflicts of interest (intrapersonal, interpersonal, interprofessional and interagency), the importance of professional judgement in uncertain situations when both action and inaction have potentially negative consequences and the importance of trust. The Delphi exercise was an effective means to bring together a wide range of professional and disciplinary perspectives on a complex topic. Findings caution against the oversimplification of the conceptual and practical issues, emphasise the importance of professional judgement, and support the development of open and trusting relationships with families and among professionals in health and social care agencies.

This article describes the findings of a mixed method literature review that examined the perceptions of elderly patients and residents of a good nurse in nursing homes, hospitals and home care. According to elderly patients and residents, good nurses are individuals who have the necessary technical and psychosocial skills to care for patients. They are at their disposal, promptly recognising the patients' needs. Good nurses like their job and are sincere and affectionate. They are understanding and caring. They do not hesitate to enter into a trust-based relationship with their patients. Knowing and understanding how elderly patients and nursing home residents perceive ‘the good nurse’ is crucial for providing quality care and for promoting better patient outcomes in geriatric care.

There is a tension between the preservation of academic freedom and the economic context in which the university currently finds itself. This tension embodies serious threats to global health as a result of three overlapping phenomena which impede the production and diffusion of valuable knowledge about health. These phenomena, the privatisation, commercialisation and instrumentalisation of knowledge are identified and examined in this paper in relation to human rights and international morality.

Background

Participants' understanding of clinical trials is important in informed consent. However, little is known about what information participants really want to know.

Aims

To demonstrate the existence of a discrepancy between participants' understanding and their desire to know.

Methods

The participants in clinical trials at Seoul National University Hospital were surveyed. The survey consisted of 11 statements based on the essential elements of informed consent. The participants gave two responses to each statement on a five-point Likert scale to rate their subjective understanding and desire to know, respectively. Information discrepancy was defined as the difference between these two ratings: if understanding exceeded desire to know for a particular item, it was defined as ‘over-informed’; if desire to know exceeded understanding for a particular item, it was defined as ‘under-informed’.

Results

Participants reported good understanding of ‘voluntariness’, ‘duration’, ‘study involves research’ and poor understanding of ‘confidentiality’, ‘compensation’, ‘benefits’, ‘procedures’ and ‘risks or discomforts’. For ‘risks or discomforts’, ‘who to contact’, ‘voluntariness’, ‘duration’ and ‘procedures’, participants reported high desire to know compared with ‘confidentiality’, ‘purpose’, ‘study involves research’ and ‘benefits’. The elements ‘study involves research’, ‘voluntariness’, ‘duration’, ‘purpose’ and ‘who to contact’ were over-informed, while ‘compensation’, ‘risks or discomforts’, ‘procedures’, ‘confidentiality’ and ‘benefits’ were under-informed. Participants over 50 years of age, those without a college education and those whose participation was less voluntary were relatively less informed about the clinical trials.

Conclusions

An information discrepancy was observed between the participants' understanding and their desire to know. By putting more emphasis on under-informed elements, the quality of informed consent could be improved.

Advances in neuromodulation and an improved understanding of the anatomy and circuitry of psychopathology have led to a resurgence of interest in surgery for psychiatric disease. Clinical trials exploring deep brain stimulation (DBS), a focally targeted, adjustable and reversible form of neurosurgery, are being developed to address the use of this technology in highly selected patient populations. Psychiatric patients deemed eligible for surgical intervention, such as DBS, typically meet stringent inclusion criteria, including demonstrated severity, chronicity and a failure of conventional therapy. Although a humanitarian device exemption by the US Food and Drug Administration exists for its use in obsessive-compulsive disorder, DBS remains a largely experimental treatment in the psychiatric context, with its use currently limited to clinical trials and investigative studies. The combination of a patient population at the limits of conventional therapy and a novel technology in a new indication poses interesting challenges to the informed consent process as it relates to clinical trial enrollment. These challenges can be divided into those that relate to the patient, their disease and the technology, with each illustrating how traditional conceptualisations of research consent may be inadequate in the surgical psychiatry context. With specific reference to risk analysis, patient autonomy, voluntariness and the duty of the clinician-researcher, this paper will discuss the unique challenges that clinical trials of surgery for refractory psychiatric disease present to the consent process. Recommendations are also made for an ethical approach to clinical trial consent acquisition in this unique patient population.

This study aimed to examine the thoughts and expectations of patients receiving healthcare from their physicians and evaluate the ethical aspects of these thoughts and expectations. To determine the ethical aspects of the thoughts and expectations of patients, an open-ended question was asked on the web page of the Turkish Armed Forces (TAF) Health Care Command, which is accessible to the users of the TAF intranet system (the internet system used within TAF institutions). The participants were asked to express their thoughts in their own words. A total of 804 participants answered the question by providing their input. The statements of the participants were classified separately by two public health specialists. The classification was made in accordance with the basic principles of patient rights, and they were collected under various headings including expectations about respect and care, good communication, informed consent, and fair and non-privileged distribution of healthcare services. The results show that patients tend to consider the physicians they see as solely responsible for all the negative issues that they encounter during their healthcare. This indicates that there is a need for extensive research on the underlying factors involved in the negative thoughts and feelings toward healthcare professionals in both TAF and Turkey in general.

The randomised controlled trial (RCT) constitutes a quantitative, comparative, controlled study of a particular treatment, and provides invaluable evidence regarding its pharmacotherapeutic efficacy. These studies are generally predicated upon the ethical principle of clinical equipoise. However, this may be insufficient to justify withholding treatment from a control group while assessing drug therapy in a potentially fatal disease. Thus, the criteria for randomisation, informed consent methodology and timing, and consideration of treatment options in such a scenario remain the province of medical ethics. This paper addresses the need for an RCT of ribavirin in the treatment of Crimean Congo haemorrhagic fever, and highlights underlying ethical concerns in light of the current medical, virological and ethical literature.

Systematic reviews, which were developed to improve policy-making and clinical decision-making, answer an empirical question based on a minimally biased appraisal of all the relevant empirical studies. A model is presented here for writing systematic reviews of argument-based literature: literature that uses arguments to address conceptual questions, such as whether abortion is morally permissible or whether research participants should be legally entitled to compensation for sustaining research-related injury. Such reviews aim to improve ethically relevant decisions in healthcare, research or policy. They are better tools than informal reviews or samples of literature with respect to the identification of the reasons relevant to a conceptual question, and they enable the setting of agendas for conceptual and empirical research necessary for sound policy-making. This model comprises prescriptions for writing the systematic review's review question and eligibility criteria, the identification of the relevant literature, the type of data to extract on reasons and publications, and the derivation and presentation of results. This paper explains how to adapt the model to the review question, literature reviewed and intended readers, who may be decision-makers or academics. Obstacles to the model's application are described and addressed, and limitations of the model are identified.

Respecting and protecting the confidentiality of data and the privacy of individuals regarding the information that they have given as participants in a research project is a cornerstone of complying with accepted research standards. However, in longitudinal studies, establishing and maintaining privacy is often challenging because of the necessity of repeated contact with participants. A novel internet-based solution is introduced here, which maintains privacy while at the same time ensures linkage of data to individual participants in a repeated measures design. With the use of the anonymous repeated measurements via email (ARME) procedure, two separate one-way communication systems are established through ad hoc email accounts and a secure study website. Strengths and limitations of the approach are discussed.

Backround

Education in ethics and professionalism should reflect the realities medical students encounter in the hospital and clinic.

Method

We performed content analyses on Case Observation and Assessments (COAs) written by third-year medical students about ethical and professional issues encountered during their internal medicine and paediatrics clinical clerkships.

Results

A cohort of 141 third-year medical students wrote 272 COAs. Content analyses identified 35 subcategories of ethical and professional issues within 7 major domains: decisions regarding treatment (31.4%), communication (21.4%), professional duties (18.4%), justice (9.8%), student-specific issues (5.4%), quality of care (3.8%), and miscellaneous (9.8%).

Conclusions

Students encountered a wide variety of ethical and professional issues that can be used to guide pre-clinical and clinical education. Comparison of our findings with results from similar studies suggests that the wording of an assignment (specifying "ethical" issues, "professional" issues, or both) may influence the kinds of issues students identify in their experience-based clinical narratives.

Conscientious objection

Do doctors have the right to refuse to perform certain procedures on their patients on moral or religious grounds, or does their duty to their patients override their personal moral objections? Several papers in this issue explore this perennial ethical dilemma.

Paediatrician Giles Birchley (see page 13) seeks to defend the role of the doctor's conscience in all medical decision-making, not only the cases where treatment is declined by the clinician. He observes that the role of conscience has been systematically reduced in medical practice, with a small number of controversial exceptions involving late-term abortions and stem-cell research. Birchley argues that this trend ought to be reversed, so that the clinician's conscience can serve as a kind of interface between everyday moral values and the peculiar, special-case moral frameworks that are employed in the practice of healthcare. He also suggests that allowing the physician to...

In an article published in the Archives of Disease in Childhood, paediatric intensivist Paul Baines criticises the conceptual and ethical basis for an assent requirement in paediatric research.1 Existing international research guidelines stipulate that children who cannot competently consent to research should ‘assent’ to their participation. However, Baines finds existing descriptions of assent both inadequate and contradictory. The guidelines also fail to provide a clear rationale for why children should assent to participation in research. Baines provides several arguments why assent in research may be harmful: it is confusing, it is not required for medical treatment, it may introduce tensions into the child's family (where the child and parents disagree) and it may be misused—either where assent is obtained instead of informed consent (eg, in a teenager with capacity), or to allow risks to be imposed on a child that are inappropriate for paediatric research.

Baines is...

A recent article from Archives of Disease in Childhood outlined problems with the act of gaining child assent for research participation. However the arguments used in the article are incomplete or misguided. Rather than being harmful, assent should be seen as an ethically-appropriate way in which we can engage with the child about his participation in research. While additional clarification of the concept of assent is needed, the child's family context can provide us with a valuable guide to the way we involve him in the decision-making process.