Research studies and interventions sometimes offer potential benefits to subjects that compensate for the risks they face. Other studies and interventions, which I refer to as “nonbeneficial” research, do not offer subjects a compensating potential for benefit. These studies and interventions have the potential to exploit subjects for the benefit of others, a concern that is especially acute when investigators enroll individuals who are unable to give informed consent. US regulations for research with human subjects attempt to address this (...) concern by mandating strict protections for nonbeneficial research with subjects who cannot consent. Typically, humans who cannot consent, such as children, may be enrolled in nonbeneficial research only when it poses low risks and has the potential to gather information of sufficient value to justify the risks, an appropriate surrogate gives permission on the individual’s behalf and the individual agrees (assents). In contrast, US regulations for nonbeneficial research with nonhuman primates do not include these protections, even though it too involves subjects who cannot consent and who face risks for the benefit of others. Is this difference in regulatory protections justified? Or does the principle of fairness—treat like cases alike—imply that regulations for nonbeneficial research with nonhuman primates should include protections similar to those that apply to nonbeneficial research with humans who cannot consent? (shrink)

This discussion paper considers how seldom recognised theories influence clinical ethics committees. A companion paper examined four major theories in social science: positivism, interpretivism, critical theory and functionalism, which can encourage legalistic ethics theories or practical living bioethics, which aims for theory–practice congruence. This paper develops the legalistic or living bioethics themes by relating the four theories to clinical ethics committee members’ reported aims and practices and approaches towards efficiency, power, intimidation, justice, equality and children’s interests and rights. Different approaches (...) to framing ethical questions are also considered. Being aware of the four theories’ influence can help when seeking to understand and possibly change clinical ethics committee routines. The paper is not a research report but is informed by a recent study in two London paediatric cardiac units. Forty-five practitioners and related experts were interviewed, including eight members of ethics committees, about the work of informing, preparing and supporting families during the extended process of consent to children’s elective heart surgery. The mosaic of multidisciplinary teamwork is reported in a series of papers about each profession, including this one on bioethics and law and clinical ethics committees’ influence on clinical practice. The qualitative social research was funded by the British Heart Foundation, in order that more may be known about the perioperative views and needs of all concerned. Questions included how disputes can be avoided, how high ethical standards and respectful cooperation between staff and families can be encouraged, and how minors’ consent or refusal may be respected, with the support of clinical ethics committees. (shrink)

The escalating integration of Artificial Intelligence (AI) in clinical settings carries profound implications for the doctrine of informed consent, presenting challenges that necessitate immediate attention. China, in its advancement in the deployment of medical AI, is proactively engaging in the formulation of legal and ethical regulations. This paper takes China as an example to undertake a theoretical examination rooted in the principles of medical ethics and legal norms, analyzing informed consent and medical AI through relevant literature data. The (...) study reveals that medical AI poses fundamental challenges to the accuracy, adequacy, and objectivity of information disclosed by doctors, alongside impacting patient competency and willingness to give consent. To enhance adherence to informed consent rules in the context of medical AI, this paper advocates for a shift towards a patient‐centric information disclosure standard, the restructuring of medical liability rules, the augmentation of professional training, and the advancement of public understanding through educational initiatives. (shrink)

Unlike its friendly cousin the placebo effect, the nocebo effect (the effect of expecting a negative outcome) has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent (in clinical trials and clinical practice) has centred almost exclusively on the need to inform patients (...) about intervention risks with patients to preserve their autonomy. Researchers have failed to consider the harm caused by the way in which the information is conveyed. In this paper, I argue that the magnitude of nocebo effects must be measured using control groups consisting of untreated patients. And, because the nocebo effect can produce harm, the principle of non-maleficence must be taken into account alongside autonomy when obtaining (ethical) informed consent and communicating intervention risks with patients. (shrink)

It has come to our attention that in the original article [1] information regarding dates was omitted. The data in this study were obtained in Switzerland four years before the entering into force of the new Swiss Human Research Act in 2014, when the guidelines of the Swiss Academy of Medical Sciences ceased to apply. It is important for readers to know that at the time of the study there was no binding law in Switzerland, only the more open SAMS (...) guidelines that have a different legal status. We would expect to find less variation of opinions among research ethics committee members if the study were repeated after the federal law came into force. (shrink)

It is widely believed that informed consent must be obtained from a patient for it to be morally permissible to administer to him/her a medical intervention. The same has been argued for the use of neurointerventions administered to criminal offenders. Arguments in favour of a consent requirement for neurointerventions can take two forms. First, according to absolutist views, neurointerventions shouldneverbe administered without an offender’s informed consent. However, I argue that these views are ultimately unpersuasive. The second, and (...) more plausible, form defences of the consent requirement may take are more moderate in that they accept the use of neurointerventions in some cases, but not in others. Based on common rationales for consent in medical interventions, I discuss whether four moderate approaches in defence of the informed consent requirement for medical interventions succeed in establishing that informed consent must be obtained from offenders prior to administering neurointerventions to them. I offer novel critical perspectives on approaches that have already received some attention in the literature, and I critically discuss other approaches to defending informed consent in a medical context that have not yet received due attention. Ultimately, I argue that it is not obvious that any of these considerations support a requirement of offenders’ informed consent to neurointerventions. Lastly, however, I suggest that there is at least one overlooked fact as regards how courts currently employ mandatory neurointerventions, which may support such a requirement. (shrink)

Consent can only be voluntary, freely given and uncoerced. Can this legal adult standard also apply to children? High-risk surgery is seldom a wanted choice, but compared with the dangers of the un...

The ongoing legal and bioethics debates on consent requirements for collecting, storing, and utilizing human biological material for purposes of basic and applied research—that is, genomic research biobanking—have already managed to pass through three ostensibly dissimilar stages.

Background 300 million operations and procedures are performed annually across the world, all of which require a patient’s informed consent. No standardised measure of the consent process exists in current clinical practice. We aimed to define a core outcome set for informed consent for therapy. Methods The core outcome set was developed in accordance with a predefined research protocol and the Core OutcoMes in Effectiveness Trials methodology comprising systematic review, qualitative semi structured interviews, a modified Delphi process (...) and consensus webinars to ratify outcomes for inclusion in the final core outcome set.. Participants from all key stakeholder groups took part in the process, including patients and the public, healthcare practitioners and consent researchers. Results 36 outcome domains were synthesised through systematic review and organised into a consent taxonomy. 41 semi-structured interviews were performed with all consent stakeholders groups. 164 participants from all stakeholder groups across 8 countries completed Delphi Round 1 and 125 completed Round 2. 11 outcomes met the ‘consensus in’ criteria. 6 met ‘consensus in’ all stakeholder groups and were included directly in the final core outcome set. 5 remaining outcomes meeting ‘consensus in’ were ratified over two consensus webinars. 9 core outcomes were included in the final core outcome set: Satisfaction with the quality and amount of information, Patient feeling that there was a choice, Patient feeling that the decision to consent was their own, Confidence in the decision made, Satisfaction with communication, Trust in the clinician, Patient satisfaction with the consent process, Patient rated adequacy of time and opportunity to ask questions. Conclusion This international mixed-methods qualitative study is the first of its kind to define a core outcome set for informed consent for intervention. It defines what outcomes are of importance to key stakeholders in the consent process and is a forward step towards standardising future consent research. (shrink)

Objective: To evaluate moral development as an indicator of the capacity to consent among two groups of patients from the Hospital de Clínicas in Porto Alegre, RS, Brazil.Method: Fifty-nine adolescents and 60 patients over 60 years of age participated in a cross-sectional study to assess moral development using Loevinger’s model of ego stages.Results: Age and moral development showed no association, with most participants in the two groups being in the conscientious phase.Conclusions: Age is probably not an adequate variable to (...) measure decision-making capacity, because questions of medical consent relate to participants’ own personal health. Decision-making capacity should be viewed as a continuous function. While the age of the person whose consent is needed should be considered, age alone, from a moral perspective, is not the main determinant of this capacity. (shrink)

BackgroundObtaining informed consent for intravenous thrombolysis in acute ischemic stroke can be challenging, and little is known about if and how the informed consent procedure is performed by neurologists in clinical practice. This study examines the procedure of informed consent for intravenous thrombolysis in acute ischemic stroke in high-volume stroke centers in the Netherlands.MethodsIn four high volume stroke centers, neurology residents and attending neurologists received an online questionnaire concerning informed consent for thrombolysis with tissue-type plasminogen activator (...) (tPA). The respondents were asked to report their usual informed consent practice for tPA treatment and their considerations on whether informed consent should be obtained.ResultsFrom the 203 invited clinicians, 50% (n = 101) completed the questionnaire. One-third of the neurology residents (n = 21) and 21% of the neurologists (n = 8) reported that they always obtain informed consent for tPA treatment. If a patient is not capable of providing informed consent, 30% of the residents (n = 19) reported that they start tPA treatment without informed consent. In these circumstances, 53% of the neurologists (n = 20) reported that the resident under their supervision would start tPA treatment without informed consent. Most neurologists (n = 21; 55%) and neurology residents (n = 45; 72%) obtained informed consent within one minute. None of the respondents used more than five minutes for informed consent. Important themes regarding obtaining informed consent for treatment were patients’ capacity, and medical, ethical and legal considerations.ConclusionThe current practice of informed consent for thrombolysis in acute ischemic stroke varies among neurologists and neurology residents. If informed consent is obtained, most clinicians stated to obtain informed consent within one minute. In the future, a shortened information provision process may be applied, making a shift from informed consent to informed refusal, while still considering the patient’s capacity, stroke severity, and possible treatment delays. (shrink)

Pragmatic clinical trials are a relatively new methodological approach to the execution of clinical research that can increase research efficiency and provide access to unique data. Some have suggested that the costs and delays associated with obtaining informed consent could make PCTs difficult or even impossible to execute. Alternative consent models have been proposed, some of which lower standards of disclosure, delay consent, or waive it altogether. We analyze the permissibility of changes to informed consent in (...) the context of Canadian research ethics policies, legislation, common law, professional codes of ethics, and professional standards of practice. We find that Canadian law and policy relating to informed consent clearly applies to any clinician who might be involved in a PCT. In addition, existing consent norms seem unable to accommodate alternative consent models for pragmatic research if such models would involve lowering the standard of disclosure. The strong emphasis on the primacy... (shrink)

The obligation to inform and obtain the consent of human subjects is axiomatic in social and medical research. Yet educational researchers are often reluctant to inform their subjects: class teachers and headteachers, for example, are often used as gatekeepers, and investigators sometimes do not so much seek consent as assume it. This chapter discusses the principle of informed consent, in particular that of children. It proposes guidelines for gatekeepers who may be called upon to authorise research and (...) to grant to investigators access to children in their care. (shrink)

In recent years a concern with the value of personal autonomy has come to dominate discussions in medical ethics. This emphasis on autonomy has naturally led to discussions of what criteria must be met for a person to be autonomous, or to be autonomous with respect to her decisions, her actions, or those of her desires that motivate her to make or to perform the decisions or the actions that she makes or does. It has also led to discussions of (...) whether autonomy is valuable in itself, instrumentally valuable, or whether its value is a combination of the two: that a person’s autonomy is valuable to her not merely as a means to securing something else that she finds valuable, but is valuable as its possession is part of what makes her life go well.Questions that concern the value of autonomy are necessarily linked to the prior question of the precise nature of autonomy. There are two main approaches to answering this question within the Western philosophical tradition. The first is Kantian .. (shrink)

Objectives The objectives of the study are to understand the current practice of informed consent in medical research in public hospitals in Shanghai, and to share our views with other countries, especially developing countries. Methods In the study, 145 consent forms (CFs) of the selected research projects in eight public hospitals with ethics committees in Shanghai were audited, and the principle investigators (PIs) of these research projects and 40 student subjects who had participated in clinical drug tests were (...) surveyed by questionnaires. Results The CFs of medical researches in public hospitals with ethics committees in Shanghai were generally acceptable. However, there were some defects in the CFs. Although most of the surveyed PIs had correct recognition of informed consent, some processes of informed consent were not in accordance with generally accepted requirements. A large number of the PIs considered the greatest difficulty with informal consent was lack of correct recognition of subjects or legally authorised representatives on medical research. Discussion Informed consent in medical research should consider the research ethics, the background of potential subjects, the local resources and culture of medical research. In addition, special protection is needed for student subjects in informed consent as well as efforts for building and restoring the public's trust in biomedical research. Conclusion The informed consent in Shanghai's public hospitals with ethics committees was generally acceptable and the achievement of adequate informed consent is influenced by many factors. (shrink)

For Alesha to give valid and sufficient consent to a COVID-19 vaccine, she must possess both capacity and competency. Let us consider each in turn.Does Alesha have capacity? Is she approaching her...

The following case was presented by a trainee general practitioner, working in inner London, to her release course for discussion. It is told, as it was presented, in the immediate aftermath of the events described. The names and some of the details have been altered.

While parents have traditionally provided proxy consent for minors to participate in research, this has proven inadequate for adolescents who are mentally and emotionally capable of making their own decisions. Research has proven that even young children, and certainly most adolescents, are developmentally prepared to make such decisions for themselves. The author challenges the assumption that both consent and assent are static concepts, and proposes that a sliding scale of competence be created to ascertain the adolescent's comprehension of (...) the proposed research by shifting the burden of proof to those who believe a particular adolescent is unable to provide informed consent. (shrink)

How are we meant to behave? And how are we to defend whatever answer we give? Morals and Consent grounds our notion of morality in natural evolution, and from that basis, Malcolm Murray shows why contractarianism is a far more viable moral theory than is widely believed. The scope of Morals and Consent has two main parts: theory and application. In his discussion of theory, Murray defends contractarianism by appealing to evolutionary game theory and metaethical analyses. His main (...) argument is that we are not going to find morality as an objective fact in the world, and that instead, we can understand morality as a reciprocal cooperative trait. From this minimal moral architecture, Murray derives his innovative consent principle. The application of the theory, detailing what contractarians can – or ought to – say about moral matters, takes up the greater portion of the work. Murray offers a trenchant examination of what moral constraints we can claim concerning death, sex, beneficence, and liberty. By focusing on evolutionary contractarianism and the epistemic justification of our moral claims – or lack thereof – Malcolm Murray’s Morals and Consent is a serious advance in the field of applied ethics and fills an important void. (shrink)

Purpose: To determine the relative value that patients place on consent for procedures in the emergency department and to define a set of procedures that fall in the realm of implied consent. Methods: A questionnaire was administered to a convenience sample 134 of 174 patients who were seen in the ED of a Midwestern teaching hospital. The questionnaire asked how much time they believed was necessary to give consent for various procedures. Procedures ranged from simple to complex. (...) Results: Participants valued a simple blood draw at a low mean of 1.02 minutes of extra time and a lumbar puncture at a high mean of 7.78 minutes. Of all participants 52% and 48% noted a time-value of “0” time on blood draw and intravenous line starts, respectively, indicating that they desire no additional consent for these procedures. Conclusion: Defining a set of ED procedures covered under implied consent will be difficult because many patients value formal consent for even the simplest procedure. (shrink)

Background The principles of dynamic consent are based on the idea of safeguarding the autonomy of individuals by providing them with personalized options to choose from regarding the sharing and utilization of personal health data. To facilitate the widespread introduction of dynamic consent concepts in practice, individuals must perceive these procedures as useful and easy to use. This study examines the user experience of a dynamic consent-based application, in particular focusing on personalized options, and explores whether this (...) approach may be useful in terms of ensuring the autonomy of data subjects in personal health data usage. Methods This study investigated the user experience of MyHealthHub, a dynamic consent-based application, among adults aged 18 years or older living in South Korea. Eight tasks exploring the primary aspects of dynamic consent principles–including providing consent, monitoring consent history, and managing personalized options were provided to participants. Feedback on the experiences of testing MyHealthHub was gathered via multiple-choice and open-ended questionnaire items. Results A total of 30 participants provided dynamic consent through the MyHealthHub application. Most participants successfully completed all the provided tasks without assistance and regarded the personalized options favourably. Concerns about the security and reliability of the digital-based consent system were raised, in contrast to positive responses elicited in other aspects, such as perceived usefulness and ease of use. Conclusions Dynamic consent is an ethically advantageous approach for the sharing and utilization of personal health data. Personalized options have the potential to serve as pragmatic safeguards for the autonomy of individuals in the sharing and utilization of personal health data. Incorporating the principles of dynamic consent into real-world scenarios requires remaining issues, such as the need for powerful authentication mechanisms that bolster privacy and security, to be addressed. This would enhance the trustworthiness of dynamic consent-based applications while preserving their ethical advantages. (shrink)

Given the increase in research in less developed countries and the necessary reliance on informed consent guidelines, we should pay close attention to the extent to which these guidelines address important cross-cultural differences. I argue that the current underlying conception of autonomy that is reflected in informed consent guidelines fails to adequately address important cultural differences—namely differences in conceptions of the person. Since this conception directly influences one’s conception of autonomy, the narrowness of the current guidelines demands attention. (...) In examining a conception of the person that is popular in Africa—a less developed country in which much research is currently being conducted—I argue that the current foundation for informed consent should rest on strong relational autonomy in order to be more globally applicable. This revision, in turn, calls for changes to the policies for informed consent. (shrink)

Background To identify and to summarize challenges related to the informed consent process for research completed during humanitarian emergencies. Methods Using relevant search terms, a search of 5 databases was completed, without language, date, or study type restriction. Studies were screened for inclusion, with eligible studies being those that were relevant to the informed consent process for research studies completed in humanitarian emergencies. A Grounded Theory Analysis was completed to identify themes and subthemes. Results Review identified 30 relevant (...) studies. We identified 11 challenges (lack of trust, therapeutic misconception, reduced capacity, security and privacy concerns, harmful research, power differential, literacy, language/local and cultural context, researcher burden and re-evaluation of ongoing trials) and 7 strategies (engage local research communities, use alternative to standard written consent process, modify traditional process of research ethics board review, dynamic consent, training of research staff, mandating transparency of commercial interests, and mandating reporting of informed consent process in all publications) to confront the challenges. These challenges and strategies were unique to the informed consent process in research conducted during humanitarian emergencies. Conclusions This scoping review identified an evidence-based guide for researchers and research ethics boards to perform ethical informed consent procedures in humanitarian emergencies. Trial Registration This trial was not registered as scoping reviews can not be registered as per updated PROSPERO guidelines. (shrink)