In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent (...) of parents for research is compromised in these two scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research-care context. (shrink)

This paper discusses how to apply a collective decision model of the principle of voluntary informed consent in African communitarian culture, in a culturally sensitive way, in order to protect research candidates from potential exploitations and abuses. Dismissing cultural and ethical skepticism surrounding the global application of the principle of voluntary informed consent, the paper ultimately concludes that international collaboration on diagnostic and therapeutic medical research in Africa, especially HIV vaccine trials, is a moral (...) imperative. (shrink)

Feminists have argued that oppressive socialization undermines the liberal model of autonomy. We contend that this argument can also be employed effectively as a challenge to the standard bioethical model of informed consent. We claim that the standard model is inadequate because it relies on presumptions of procedural autonomy and rational choice that overlook the problem of how agents are often socialized so that they adopt and internalize oppressive norms as part of their motivational structure. The argument that (...) oppressive socialization undermines liberalism’s view of autonomy is most relevant to what Beauchamp and Childress call the threshold elements of informed consent—competence and voluntariness. We show how these elements fail to account for morally relevant factors such as oppressive socialization. (shrink)

BackgroundInformed consent as stipulated in regulatory human research guidelines requires volunteers to be well-informed about what will happen to them in a trial. However, researchers may be faced with the challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. This study aimed to find out volunteers’ comprehension of informed consent and voluntary participation in Human Immunodeficiency Virus (HIV) clinical trials during the registration cohort.MethodsWe conducted (...) a qualitative study among volunteers who were enrolled in the registration cohort of HIV clinical trials in Dar es Salaam, Tanzania. A purposive sampling strategy was used to obtain twenty study participants. The data were collected between June and September 2020 using a semi-structured interview guide. In-depth interviews were used to collect the data to obtain deep insights of the individual study participants on the comprehension of informed consent and participation in the clinical trial. A thematic analysis approach was used to analyze the data. Themes and subthemes were supported by the quotes from the participants.ResultsVolunteers described comprehension of informed consent from different perspectives. They reported that various components of the informed consent such as study procedure, confidentiality, risk and benefits were grasped during engagement meetings. Furthermore, the volunteers’ decision to participate in the registration cohort was voluntary. However, trial aspects such as health insurance, free condoms, and medical checkups could have indirectly influenced their reluctance to withdraw from the study.ConclusionEngagement meetings may increase the comprehension of informed consent among potential participants for HIV clinical trials. However, trial incentives may influence participation, and thus future research should focus on the challenges of giving incentives in the study. This will ensure comprehension and voluntary participation in the context of HIV clinical trials. (shrink)

In an earlier article in this journal I argued that the question of whether heroin addicts can give voluntary consent to take part in research which involves giving them a choice of free heroin does not – in contrast with a common assumption in the bioethics literature – depend exclusively on whether or not they possess the capacity to resist their desire for heroin. In some cases, circumstances and beliefs might undermine the voluntariness of the choices a person (...) makes even if they do possess a capacity for self-control. Based on what I took to be a plausible definition of voluntariness, I argued that the circumstances and beliefs typical of many vulnerable heroin addicts are such that we have good reasons to suspect they cannot give voluntary consent to take part in such research, even assuming their desire for heroin is not irresistible. In a recent article in this journal, Uusitalo and Broers object to this on the grounds that I misdescribe heroin addicts' options set, that the definition of voluntariness on which I rely is unrealistic and too demanding, and, more generally, that my view of heroin addiction is flawed. I think their arguments derive from a misunderstanding of the view I expressed in my article. In what follows I hope therefore to clarify my position. (shrink)

Studies on informed consent to medical research conducted in low or middle-income settings have increased, including empirical investigations of consent to genetic research. We investigated voluntary participation and comprehension of informed consent among women involved in a genetic epidemiological study on breast cancer in an urban setting of Nigeria comparing women in the case and control groups.

Does addiction to heroin undermine the voluntariness of heroin addicts' consent to take part in research which involves giving them free and legal heroin? This question has been raised in connection with research into the effectiveness of heroin prescription as a way of treating dependent heroin users. Participants in such research are required to give their informed consent to take part. Louis C. Charland has argued that we should not presume that heroin addicts are competent to do (...) this since heroin addiction by nature involves a loss of ability to resist the desire for heroin. In this article, I argue that Charland is right that we should not presume that heroin addicts are competent to consent, but not for the reason he thinks. In fact, as Charland's critics correctly point out, there is plenty of evidence showing that heroin addicts can resist their desire for heroin. These critics are wrong, however, to conclude from this that we should presume that heroin addicts are competent to give their voluntary consent. There are, I shall argue, other conditions associated with heroin addiction that might constrain heroin addicts' choice in ways likely to undermine the voluntariness of their consent. In order to see this, we need to move beyond the focus on the addicts' desires for heroin and instead consider the wider social and psychological circumstances of heroin addiction, as well as the effects these circumstances may have on the addicts' beliefs about the nature of their options. (shrink)

This study in the context of short-stay surgery is based on a definition according to which informed consent consists of five elements: consent, voluntariness, disclosure of information, understanding and competence. The data were collected in four district hospitals in southern Finland by using a structured questionnaire. The population consisted of short-stay and one-day surgery patients (n = 107). Data analysis was based on statistical methods. The results indicated some problems in the realization of informed consent. (...) Most commonly, consent was expressed by voluntary admission. Most patients had indicated their voluntary consent by making their decision independently. There were also certain problems with information. The respondents were least well informed about the drawbacks of anaesthesia and about alternative forms of treatment. The patients had not understood all the information they had received; problems of understanding were greatest with information about the advantages and disadvantages of anaesthesia. Problems were also reported with competence. These patients had the most difficulty in assessing the advantages and drawbacks of different treatments and anaesthesia. (shrink)

Can heroin addicts give consent to research on trials in which heroin is prescribed to them? Analyses of addicts and informed consent have been objects of debate in several articles. Informed consent requires the agent not only to be competent but also to give consent voluntarily. This has been questioned because of alleged features of heroin addiction. Until recently the discussion has focused on heroin addicts' desires for heroin, whether these are irresistible and thus (...) pose a problem for giving consent. Still, in light of empirical evidence, there seems to be a consensus more or less that the problem is not whether the addicts can resist their desire for heroin. A recent article concentrates specifically on heroin addicts' false assumptions of options and voluntariness. We argue that the prevailing framing of the options in this discussion in terms of heroin and access to it is problematic. The way in which the options are typically laid out suggests an assumption that participation in the research is allegedly based on the addicts' views on using the drug. We argue that this way of presenting the options is, first, a mismatch to the studies carried out and, second, symptomatic of potential misconceptions about heroin addiction and addicts. Furthermore, we also suggest that the account of voluntariness needs to be realistic in order for subjects to be able to give consent voluntarily in actual situations, and for medical research to carry out studies on improving outcomes in addiction treatment in an ethical way. (shrink)

Introduction Informed consent is a body of shared decision-making process and voluntary authorization of patients to receive medical or surgical intervention. There are limited studies conducted so far to examine the practice of informed consent in Ethiopia. This study aimed to assess the practice of informed consent process for surgery and Anesthesia. Method A cross-sectional study was conducted from March to May 2019. The data were collected using interviewer-administered structured questionnaire and analyzed in (...) SPSS version 23. Results A total of 139 patients were interviewed in this study. Most 42(30.2%) of patients were in the age group of 29–38 years. Nearly half 68 (48.9%) of the patients were informed the benefits of the surgical procedure and 78(56.1%) of the patients were informed on the type of anesthesia to be administered while 65 (46.8%) were not informed on any complication related to the anesthesia. About 66 (47.5%) of patients were informed on alternatives to the surgery. Of these patients, 39(59%) were not informed of any benefits and possible risks associated with the alternative modes of treatment. About half (54%) of the patients were reported as they were understood the information provided during the pre-operative informed consent process. Conclusion This research revealed that patients were inadequately informed on the complications of proposed procedure, alternative forms of treatment, risks and benefits of the proposed procedure. Therefore, healthcare providers should provide adequate information regarding the proposed procedure and make sure whether patients understood the risks and benefits before the consent. (shrink)

Over the past several decades the ‘affective revolution’ in cognitive psychology has emphasized the critical role affect and emotion play in human decision-making. Drawing on this affective literature, various commentators have recently proposed strategies for managing therapeutic expectation that use contextual, symbolic, or emotive interventions in the consent process to convey information or enhance comprehension. In this paper, we examine whether affective consent interventions that target affect and emotion can be reconciled with widely accepted standards for autonomous action. (...) More specifically, the ethics of affective consent interventions is assessed in terms of key elements of autonomy, comprehension and voluntariness. While there may appear to be a moral obligation to manage the affective environment to ensure valid informed consent, in circumstances where volunteers may be prone to problematic therapeutic expectancy, this moral obligation needs to be weighed against the potential risks of human instrumentalization. At this point in time we do not have enough information to be able to justify clearly the programmatic manipulation of human subjects' affective states. The lack of knowledge about affective interventions requires corresponding caution in its ethical justification. (shrink)

The ‘no-suicide contract’ is a frequently utilized tool in both the assessment and dispersal of suicidal patients. However, little attention has been given to questioning whether suicidal persons are able to give informed consent to enter such a contract. This article utilizes both the existing literature on no-suicide contracts and the results of recent research into the effects of this tool, to examine whether its use is consistent with the legal and ethical doctrine of informed consent. (...) Particular attention is given to issues of competence, fullness of information, voluntariness and paternalistic intervention when no-suicide contracts are used. This analysis finds the tool to be problematic and suggests that individual patients’ ability to give informed consent about a no-suicide contract needs to be carefully considered by clinicians. (shrink)

In controlled human infection studies (CHIs), participants are deliberately exposed to infectious agents in order to better understand the mechanism of infection or disease and test therapies or vaccines. While most CHIs have been conducted in high‐income countries, CHIs have recently been expanding into low‐ and middle‐income countries (LMICs). One potential ethical concern about this expansion is the challenge of obtaining the voluntary informed consent of participants, especially those who may not be literate or have limited education. (...) In some CHIs in LMICs, researchers have attempted to address this potential concern by limiting access to literate or educated populations. In this paper, we argue that this practice is unjustified, as it does not increase the chances of obtaining valid informed consent and therefore unfairly excludes illiterate populations and populations with lower education. Instead, we recommend that investigators improve the informed consent process by drawing on existing data on obtaining informed consent in these populations and interventions aimed at improving their understanding. Based on a literature review, we provide concrete suggestions for how to follow this recommendation and ensure that populations with lower literacy or education are given a fair opportunity to protect their rights and interests in the informed consent process. (shrink)

Informed consent is central to modern research ethics. Informed consent procedures have mainly been justified in terms of respect for autonomy, the core idea being that it should be every competent individual’s right to decide for herself whether or not to participate in scientific studies. A number of conditions are normally raised with regard to morally valid informed consent. These include that potential research subjects get adequate information, understand those aspects that are relevant to (...) them, and, based on that information, make a voluntary decision whether or not to participate. These conditions are meant to guarantee that participation is genuinely the individual’s own choice and is coherent with his or her authentic interests. (shrink)

Informed consent is the gateway to research participation. We report on the results of the formative evaluation that follows the electronic informed consent process for the All of Us Research Program. Of the nearly 250,000 participants included in this analysis, more than 95% could correctly answer questions distinguishing the program from medical care, the voluntary nature of participation, and the right to withdraw; comparatively, participants were less sure of privacy risk of the program. We also (...) report on a small mixed-methods study of the experience of persons of very low health literacy with All of Us informed consent materials. Of note, many of the words commonly employed in the consent process were unfamiliar to or differently defined by informants. In combination, these analyses may inform participant-centered development and highlight areas for refinement of informed consent materials for the All of Us Research Program and similar studies. (shrink)

Background: In Southeast Asia, the process of obtaining informed consent is influenced by both culture and policy at the hospital and national level. Both physicians and nurses play vital roles in this process, but physicians influence the roles of nurses. Objectives: Since the physicians and nurses often have different perspectives, it is important to investigate their views about the informed consent process and nurses’ roles therein and whether there is a difference between ideal and experienced practice (...) (reality), and whether this differs across hospitals. Methods: A questionnaire was developed and a survey was conducted among physicians and nurses. Using exploratory factor analysis a three factor structure was determined: ‘nurses’ roles’, ‘barriers in informed consent’, and ‘adequacy of information’. Non-parametric tests were applied to compare nurses and physicians, and hospital setting. Participants and research context: Responses were obtained from 129 physicians and 616 nurses from two Indonesian hospitals. Those hospitals differ in ownership, location, and size. Ethical consideration: The study was reviewed by the hospital ethical committee. Participation was voluntary and confidentiality was ensured by keeping the responses anonymous. Findings: Physicians and nurses differ significantly on all three factors. The scores reflecting disparity between ideal and reality regarding nurses’ roles varied across professions, while barriers in informed consent differed between hospitals. Discussion: The differences between ideal and reality indicated that improvement in the informed consent process and nurses’ roles therein is called for. Varying views between physicians and nurses on nurses’ roles may hinder collaboration. The differences between hospital settings showed interventions may have to be customized for different settings. Conclusion: Views on nurses’ roles vary across professions. Views on barriers in informed consent vary across hospitals. Therefore interprofessional education is needed to promote interprofessional collaboration and intervention to improve informed consent practice should be tailored to the hospital context. (shrink)

Whether intended or not, conceptions of informed consent are often rooted in archetypal notions of the researcher and prospective study participant. The former is assumed problematically to be a disinterested yet humanitarian individual who is well trained to conduct robust science. The latter is often characterized as being motivated by some altruistic notions about the contribution to science and society they are making even as they seek some personal benefit from the research. Cast in a dyad, the researcher (...) has the responsibility to inform the participant thoroughly about the purpose of the research, the risks and benefits of participation, and any alternatives to research available, as well as the .. (shrink)

This paper attempts to establish the epistemological import and limits of informed consent in clinical research. It points out that informed consent is a necessary requirement in clinical research because it ensures adequate participation of care receivers in issues relating to their health. Besides ensuring that care receivers have knowledge of whatever medical intervention they are consenting to, informed consent, as an ideal, provides assurance that care receivers and others are neither coerced nor deceived. (...) While the question of the value of informed consent in health care delivery is not so much controverted, in contest is the question of whether or not complete and wholly specifically informed consent can indeed be realized in medical intervention. Two orientations are identified in this debate. One insists that an individual will be able to make an informed decision and make reasonable choices amongst alternatives when fully informed. The other orientation sees as an epistemic illusion, achieving full informed consent, and rather opts for informed request. This paper examines this debate by clarifying the notion of informed consent, its components and its nexus with knowledge. The position of the paper is that informed consent is not only an ethical ideal in clinical research and health care; it is also an epistemic virtue that must be continuously strived towards. This paper establishes that health care receivers can only have an epistemic claim of their medical situation if all requirements of informed consent in health care delivery such as provision of adequate information, the risk and benefits of treatment, avoidance of vague/ambiguous statements, voluntariness, etc. are met. (shrink)

Background and objectives: There are few insights from sub-Saharan Africa on research participants’ experiences of the informed consent process, particularly in the context of randomised controlled trials, where issues of randomisation and the use of placebos may be confusing concepts for participants. This study investigated the knowledge and perceptions of the informed consent process among individuals participating in influenza vaccine trials in two disadvantaged communities in South Africa.Method: Four to 12 months after completion of the trials, (...) participants were contacted to return to participate in the informed consent study. The semistructured questionnaire administered to assess recall of trial procedures and the informed consent process covered key issues including: purpose of the study; awareness that the study was not part of routine treatment; voluntary nature of participation and freedom to withdraw; randomisation; placebos; and remuneration.Results: A total of 334 participants completed the questionnaire. Only 21% were able to recall that they were allocated randomly to the different treatment arms. Only 19% of those involved in the placebo controlled study had interpreted the concept of placebo as an inactive medication.Conclusion: Although a good general recall of trial concepts was demonstrated, only a small proportion of the participants correctly interpreted and recalled the concepts of randomisation and placebos. Informed consent in this and similarly disadvantaged communities may often be inadequate and new ways to improve understanding of the research process should be explored. (shrink)

Background. Informed consent (IC) is not only a regulatory but also an ethical requirement to participate in any clinical trial. It is essential to determine that research participants understand what they consent to. Studies that evaluate participants’ understanding of IC conclude that recall and understanding of IC is often low, and researchers recommend that interactive multimedia interventions should be implemented to optimise understanding. Objectives. To assess participants’ understanding of IC of the research trial that they agreed to (...) participate in.Methods. A descriptive survey design, within a quantitative research approach, was used to conduct the study at two government hospitals in the Eastern Cape Province. A semi-structured, self-administered questionnaire was used to collect information from 170 participants in research studies. Descriptive statistics were used to analyse the results.Results. Participants were recruited from among women who enrolled in any of the three studies that were ongoing at the two sites during the recruitment period. The study participants had a mean age of 25.9 years. Nearly one-third (30%) could not recall the purpose of the original trial that they consented to. The concept of randomisation was not understood by any of the participants.Conclusion. Regardless of extensive efforts to ensure that participants understood their participation, this study unveiled poor recall of essential information on IC. It is proposed that IC should be short and only address essential components such as purpose, procedure, possible risks or benefits, alternative options if not participating and explaining the concept of voluntary participation. (shrink)

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. (shrink)

How well can institutional guidelines help ensure the dignity, rights, safety and well being of research participants in an underdeveloped country? In this paper I describe the limits of informed consent as an instrument for the protection of participants in the context of the Philippines. I bring to this paper my experiences as an advocate of rights, a member of an ethics review board, a researcher on the ethics of research and as an observer of the dynamics of (...) clinical practice in an academic public teaching hospital of the University of the Philippines where I am professor. (shrink)

BackgroundThe conduct of research is critical to advancing human health. However, there are issues of ethical concern specific to the design and conduct of research in conflict settings. Conflict-affected countries often lack strong platform to support technical guidance and monitoring of research ethics, which may lead to the use of divergent ethical standards some of which are poorly elaborated and loosely enforced. Despite the growing concern about ethical issues in research, there is a dearth of information about ethical compliance in (...) conflict areas. Valid and ethically informed decision-making is a premier pact with research participants in settling possible ethical issues before commencing the research, which is ensured by gaining informed consent from prospective participants of the research.AimsThis research aimed to explore compliance with research ethics and consent validity in community-based epidemiological research conducted previously.MethodsResearch participants were recruited in the western part of Ethiopia in three districts subjected to conflicts. A community-based cross-sectional study design was utilized, and 338 residents were enrolled as study participants. All participants had previously been enrolled as research participants in epidemiological studies. Data was collected using a questionnaire that was pilot-tested before the commencement of the main data collection. The questionnaire focused on participants’ experiences of the informed consent process followed when they were recruited for an epidemiological study and covered themes such as essential information provided, level of comprehension, and voluntarism of consent.ResultsOver half of the study participants, 176 (52%), were not provided with essential information before consenting. And 135 (40%) of them did not comprehend the information provided to them. One hundred and ninety (56%) participants freely and voluntarily agreed to partake in one of these epidemiological studies, with over a quarter (97; 28.7%) of them reporting they were subjected to undue influence. Written consent was obtained from only 32 (9.4%) of the participants. (shrink)

ABSTRACT Persons generally must give their informed consent to participate in research. To provide informed consent persons must be given information regarding the study in simple, lay language. Consent must be voluntary, and persons giving consent must be legally competent to consent and possess the capacity to understand and appreciate the information provided. This paper examines the relationship between the obligation to disclose information regarding risks and the requirement that persons have the (...) capacity to understand and appreciate the information. There has been insufficient attention to the extent to which persons must be able to understand and appreciate study information in order to have their consent deemed valid when the information is provided in simple, lay language. This paper argues that (1) the capacity to understand and appreciate information that should be deemed necessary to give valid consent should be defined by the capacity of the typical, cognitively normal adult and (2) the capacity of the typical, cognitively normal adult to understand and appreciate the concept of risk is limited. Therefore, (3) all things being equal, potential subjects must possess a limited capacity to understand and appreciate risk to be deemed competent to consent to research participation. (4) In some cases investigators ought to require that persons possess a greater than typical capacity to understand and appreciate risk. (shrink)

Objective Some researchers claim that the quality of informed consent of clinical research participants in developing countries is worse than in developed countries. To evaluate this assumption, we reviewed the available data on the quality of consent in both settings. Methods We conducted a comprehensive PubMed search, examined bibliographies and literature reviews, and consulted with international experts on informed consent in order to identify studies published from 1966 to 2010 that used quantitative methods, surveyed participants (...) or parents of paediatric participants in actual trials, assessed comprehension and/or voluntariness, and did not involve testing particular consent interventions. Forty-seven studies met these criteria. We compared data about participant comprehension and voluntariness. The paucity of data and variation in study methodology limit comparison and preclude statistical aggregation of the data. Results and Discussion This review shows that the assertion that informed consent is worse in developing countries than in developed countries is a simplification of a complex picture. Despite the limitations of comparison, the data suggest that: (1) comprehension of study information varies among participants in both developed and developing countries, and comprehension of randomisation and placebo controlled designs is poorer than comprehension of other aspects of trials in both settings; and (2) participants in developing countries appear to be less likely than those in developed countries to say they can refuse participation in or withdraw from a trial, and are more likely to worry about the consequences of refusal or withdrawal. (shrink)

The aim of this study was to explore the relational aspects of the consent process for HPV vaccination as experienced by school nurses, based on the assumption that individuals have interests related to persons close to them, which is not necessarily to be apprehended as a restriction of autonomy; rather as a voluntary and emotionally preferred involvement of their close ones. Thirty Swedish school nurses were interviewed in five focus groups, before the school based vaccination program had started (...) in Sweden. The empirical results were discussed in light of theories on relational autonomy. The school nurses were convinced that parental consent was needed for HPV vaccination of 11-year-old girls, but problems identified were the difficulty to judge when a young person is to be regarded as autonomous and what to do when children and parents do not agree on the decision. A solution suggested was that obtaining informed consent in school nursing is to be seen as a deliberative process, including the child, the parents and the nurse. The nurses described how they were willing strive for a dialogue with the parents and negotiate with them in the consent process. Seeing autonomy as relational might allow for a more dialogical approach towards how consent is obtained in school based vaccination programs. Through such an approach, conflicts of interests can be made visible and become possible to deal with in a negotiating dialogue. If the school nurses do not focus exclusively on accepting the individual parent’s choice, but strive to engage in a process of communication and deliberation, the autonomy of the child might increase and power inequalities might be reduced. (shrink)

Since the Nuremberg trials (1947–1949), informed consent has become central for ethical practice in patient care and biomedical research. Codes of ethics emanating from the Nuremberg Code (1947) recognize the importance of protecting patients and research subjects from abuses, manipulation and deception. Informed consent empowers individuals to autonomously and voluntarily accept or reject participation in either clinical treatment or research. In some cases, however, the underlying mental or physical condition of the individual may alter his or (...) her cognitive abilities and compromise the informed consent process. This is particularly true in chronic psychiatric conditions such as Treatment-Resistant Depression (TRD), where individuals may fail to respond to traditional antidepressant treatments (e.g., psychotherapy, pharmacotherapy). Moreover, it may raise further concerns for an individual’s motivation to consent and the level of understanding of the treatment or research procedure. This paper focuses on the informed consent process for Vagus Nerve Stimulation (VNS) in the treatment of individuals diagnosed with TRD. Specifically, the paper addresses how depression may affect the decision-making capacity of an individual and the potential ethical and legal impact of failure to appreciate the seven elements of the consenting process (competence, voluntariness, disclosure, recommendation, understanding, decision, and authorization). To ensure the protection of vulnerable individuals with psychiatric disorders such as TRD and promote ethical behavior in biomedical research and patient care while avoiding potential legal pitfalls, we propose a paradigm that requires a stringent evaluation process of decision-making capacity for informed consent. (shrink)

BackgroundResearchers conducting community-based participatory action research (CBPAR) in highly collectivistic and socioeconomically disadvantaged community settings in sub-Saharan Africa are confronted with the distinctive challenge of balancing universal ethical standards with local standards, where traditional customs or beliefs may conflict with regulatory requirements and ethical guidelines underlying the informed consent (IC) process. The unique ethnic, socioeconomic, and cultural diversities in these settings have important implications for the IC process, such as individual decisional autonomy, beneficence, confidentiality, and signing the IC (...) document.Main textDrawing on insights and field observations from conducting CBPARs across several rural, highly communal, low literate, and low-income communities in Ghana, we discuss some theoretical, ethico-cultural, and methodological challenges associated with applying the universal, Western individualistic cultural value-laden IC process in sub-Saharan Africa. By citing field situations, we discuss how local cultural customs and the socioeconomic adversities prevalent in these settings can influence (and disrupt) the information disclosure process, individual decisional authority for consent, and voluntariness. We review the theoretical assumptions of the Declaration of Helsinki’s statement on IC and discuss its limitations as an ultimate guide for the conduct of social science research in the highly communal African context. We argue that the IC process in these settings should include strategies directed at preventing deception and coercion, in addition to ensuring respect for individual autonomy. We urge Universities, research institutions, and institutional review boards in Africa to design and promote the use of context-appropriate ethical IC guidelines that take into consideration both the local customs and traditional practices of the people as well as the scientific principles underpinning the universal IC standards.ConclusionWe recommend that, rather than adopt a universal one-size-fits-all IC approach, researchers working in the rural, highly collectivistic, low literate, socioeconomically disadvantaged settings of sub-Saharan Africa should deeply consider the roles and influence of cultural values and traditional practices on the IC and the research process. We encourage researchers to collaborate with target communities and stakeholders in the design and implementation of context-appropriate IC to prevent ethics dumping and safeguard the integrity of the research process. (shrink)

Interventions in medicine require multicenter clinical trialson a large rather than limited number of subjects from various genetic and cultural backgrounds. International guidelines to protect the rights and well-being of human subjects involved in clinical trialsarecriticizedforthe priority they place on Western cultural values. These discussions become manifest especially with regard to the content and methodology of the informed consent procedure. The ethical dilemma emerges from the argument that there are fundamental differences about the concept of respect for the (...) autonomy of individuals in different cultures and religions. Some communities prioritize the consent of community leaders or the head of family –usually men – over the voluntary and free consent of the individual. The aim of this work is to discuss this ethical dilemma to determine a base for a consensus that satisfies the sensibilities of different cultures without damaging the rights and autonomy of human subjects. (shrink)

Debates over research ethics have until recently revolved around two related questions: the voluntary, informed consent of subjects, and the appropriate relationship between risk and benefit to subjects in the experiment. Recently more attention has been paid to issues of justice in research studies, especially in the international arena, and to issues of the scientific and financial probity of researchers. Yet these new foci augment rather than supplant the traditional focus on consent, since arguably “the rights (...) and wellbeing of the subject take precedence over the interests of science and society”, as the Declaration of Helsinki (still) puts it. Clinically the difficulties of obtaining the informed consent of subjects to participation in research remain one of the more difficult barriers to research. Recently this issue has become more fraught in non-clinical research also, with complex debates over consent to the use and reuse of clinical …. (shrink)

Our primary focus is on analysis of the concept of voluntariness, with a secondary focus on the implications of our analysis for the concept and the requirements of voluntary informed consent. We propose that two necessary and jointly sufficient conditions must be satisfied for an action to be voluntary: intentionality, and substantial freedom from controlling influences. We reject authenticity as a necessary condition of voluntary action, and we note that constraining situations may or may not (...) undermine voluntariness, depending on the circumstances and the psychological capacities of agents. We compare and evaluate several accounts of voluntariness and argue that our view, unlike other treatments in bioethics, is not a value-laden theory. We also discuss the empirical assessment of individuals? perceptions of the degrees of noncontrol and self-control. We propose use of a particular Decision Making Control Instrument. Empirical research using this instrument can provide data that will help establish appropriate policies and procedures for obtaining voluntary consent to research. (shrink)

BackgroundAn increasing number of studies utilize intracranial electrophysiology in human subjects to advance basic neuroscience knowledge. However, the use of neurosurgical patients as human research subjects raises important ethical considerations, particularly regarding informed consent and undue influence, as well as subjects’ motivations for participation. Yet a thorough empirical examination of these issues in a participant population has been lacking. The present study therefore aimed to empirically investigate ethical concerns regarding informed consent and voluntariness in Parkinson’s disease (...) patients undergoing deep brain stimulator (DBS) placement who participated in an intraoperative neuroscience study.MethodsTwo semi-structured 30-minute interviews were conducted preoperatively and postoperatively via telephone. Interviews assessed participants’ motivations for participation in the parent intraoperative study, recall of information presented during the informed consent process, and participants’ postoperative reflections on the research study.ResultsTwenty-two participants (mean age = 60.9) completed preoperative interviews at a mean of 7.8 days following informed consent and a mean of 5.2 days prior to DBS surgery. Twenty participants completed postoperative interviews at a mean of 5 weeks following surgery. All participants cited altruism or advancing medical science as “very important” or “important” in their decision to participate in the study. Only 22.7% (n = 5) correctly recalled one of the two risks of the study. Correct recall of other aspects of the informed consent was poor (36.4% for study purpose; 50.0% for study protocol; 36.4% for study benefits). All correctly understood that the study would not confer a direct therapeutic benefit to them.ConclusionEven though research coordinators were properly trained and the informed consent was administered according to protocol, participants demonstrated poor retention of study information. While intraoperative studies that aim to advance neuroscience knowledge represent a unique opportunity to gain fundamental scientific knowledge, improved standards for the informed consent process can help facilitate their ethical implementation. (shrink)

Background Informed consent is often cited as the “cornerstone” of research ethics. Its intent is that participants enter research voluntarily, with an understanding of what their participation entails. Despite agreement on the necessity to obtain informed consent in research, opinions vary on the threshold of disclosure necessary and the best method to obtain consent. We aimed to investigate Australian researchers’ views on, and their experiences with, obtaining informed consent. Methods Semi-structured interviews were conducted (...) with 23 researchers from NSW institutions, working in various fields of research. Interviews were analysed and coded to identify themes. Results Researchers reported that consent involved information disclosure, understanding and a voluntary decision. They emphasised the variability of consent interactions, which were dependent on potential participants’ abilities and interests, study complexity and context. All researchers reported providing written information to potential participants, yet questioned the readability and utility of this information. The majority reported using signed consent forms to ‘operationalise’ consent and reported little awareness of, and lack of support in implementing more dynamic informed consent procedures, such as verbal informed consent, that was fit for the purposes of their studies. Views on Human Research Ethics Committees varied. Some reported inconsistent, arduous inputs on the information form and consent process. Others expressed reliance on HRECs for guidance, viewing them as institutional safeguards. Conclusions This study highlights the importance of transparent relationships, both between researchers and participants, and between researchers and HRECs. Where the relationship with study participants was reported as more robust, researchers felt that they were better able to ensure participants made better, more informed decisions. Where the relationship with HRECs was reported as more robust, researchers were more likely to view them as institutional safeguards, rather than as bureaucratic hindrances. Conscientious and mindful researchers are paramount to ensuring the procedure accommodates individual requirements. This study advocates that when designing ethical informed consent practices, researchers should be integrated as autonomous players with a positive input on the process, rather than, in the worst case, predatory recruiters to be curtailed by information forms and oversight. (shrink)

Candidate evaluation for breast implantation presents a more important obstacle to the fulfillment of the normative requirements of informed consent than do the social roles of women or cultural norms governing female beauty. I argue that women's decisions to receive breast implants may indeed be informed, competently made, and substantially voluntary, but that the cultural construction of beauty may undermine women's autonomy by influencing the evaluation of surgical candidates and risk disclosure during informed consent.

The influence of physician judgment on the disclosure, competency, understanding, voluntariness, and decision aspects of informed consent for bone marrow transplantation are described. Ethical conflicts which arise from the amount and complexity of the information to be disclosed and from the barriers of limited time, patient anxiety and lack of prior relationship between patient and physician are discussed. The role of the referring physician in the decision-making is considered. Special ethical issues which arise with use of healthy related (...) bone marrow donors are discussed, as is the physician's discretion in raising questions of competency. It is concluded that in this setting, regardless of the theoretical goals of the physician, patients appear to utilize informed consent discussions to assess their capacity to trust the physician rather than as a time to weigh the large amount of relevant data. The conscientious physician best serves the patient with recommendation of the best medical alternative rather than with attempts to remain neutral. (shrink)

Voluntariness is a necessary condition of valid consent. But determining whether a person consented voluntarily can be difficult, especially when people are subjected to coercion or manipulation, placed in a situation with no acceptable alternative other than to consent to something, or find themselves in an abusive relationship. This book presents a novel view on the voluntariness of consent, especially medical consent, which the author calls Interpersonal Consenter-Consentee Justification (ICCJ). According to this view, consent is (...) voluntary if and only if the process by which it has been obtained aligns with principles of interpersonal justification. ICCJ is distinctive because it explains voluntary consent neither as a 'psychological' concept indicative of the inner states of a person's mind (e.g. willingness or reluctance) nor as a 'circumstantial' concept indicative of a person's set of options. Rather, ICCJ explains the voluntariness of consent as an 'interpersonal' concept requiring the absence of illegitimate control within the interaction between the person giving consent and the person receiving it. In so doing, ICCJ further develops the notion of interpersonal justification, known from contractualist theories in moral philosophy, and introduces it to the debate on consent. The author employs a top-down approach, defending ICCJ's key characteristics on the basis of general theoretical arguments, as well as a bottom-up approach, supporting ICCJ in its application to clinical challenges such as nudging and manipulation, living organ donation, and clinical trials. Voluntary Consent will appeal to researchers and advanced students in normative ethics, bioethics, philosophy of law, behavioural psychology, and medicine. (shrink)

This narrative symposium examines the relationship of bioethics practice to personal experiences of illness. A call for stories was developed by Tod Chambers, the symposium editor, and editorial staff and was sent to several commonly used bioethics listservs and posted on the Narrative Inquiry in Bioethics website. The call asked authors to relate a personal story of being ill or caring for a person who is ill, and to describe how this affected how they think about bioethical questions and the (...) practice of medicine. Eighteen individuals were invited to submit full stories based on review of their proposals. Twelve stories are published in this symposium, and six supplemental stories are published online only through Project MUSE. Authors explore themes of vulnerability, suffering, communication, voluntariness, cultural barriers, and flaws in local healthcare systems through stories about their own illnesses or about caring for children, partners, parents and grandparents. Commentary articles by Arthur Frank, Bradley Lewis, and Carol Taylor follow the collection of personal narratives. (shrink)

Background: Informed consent is regarded as a contract between autonomous and equal parties and requires the elements of information disclosure, understanding, voluntariness and consent. The validity of informed consent for critically ill patients has been questioned. Little is known about how these patients experience the process of consent.Objective: The aim of this study was to explore critically ill patients’ experience with the principle of informed consent in a clinical trial and their ability (...) to give valid informed consent.Design: 11 stroke patients who had been informed about thrombolytic treatment and had been through the process of deciding whether or not to participate in a thrombolysis trial went through repeated qualitative semistructured interviews.Results: None of the patients had any clear understanding of the purpose of the trial. Neither did they understand the principles of randomisation and voluntariness. Reasons for giving or not giving consent were trust, conceptions of benefits and risks and altruism. Several patients found it immoral to involve patients in the consent procedure and argued that this was the doctors’ responsibility. Others argued that it is a duty to question patients and perceived it as a sign of being treated with respect and dignity. A majority of the patients found the consent process vague and ambiguous.Conclusions: The results indicate that the principle of informed consent from critically ill patients cannot be seen as a contract between equal and autonomous parties. Further studies are needed to explore critically ill patients’ experiences with the process of informed consent. (shrink)

Some are concerned about the possibility that offering money for research participation can constitute coercion or undue influence capable of distorting the judgment of potential research subjects and compromising the voluntariness of their informed consent. The author recognizes that more often than not there are multiple influences leading to decisions, including decisions about research participation. The concept of undue influence is explored, as well as the question of whether or not there is something uniquely distorting about money as (...) opposed to a chance for treatment or medical care. An amount of money that is not excessive and is calculated on the basis of time or contribution may, rather than constitute an undue inducement, be an indication of respect for the time and contribution that research subjects make. (shrink)

Criminal offenders may be offered to participate in voluntary rehabilitation programs aiming at correcting undesirable behaviour, as a condition of early release. Behavioural treatment may include direct intervention into the central nervous system (CNS). This article discusses under which circumstances voluntary rehabilitation by CNS intervention is justified. It is argued that although the context of voluntary rehabilitation is a coercive circumstance, consent may still be effective, in the sense that it can meet formal criteria for (...) class='Hi'>informed consent. Further, for a consent to be normatively valid (“take the wronging out of the act”) under a coercive circumstance, the subject to be treated must (1) have the sovereign authority to consent, and (2) the offer-giver must be in the right normative position to make the offer. While I argue that subjects do have the sovereign authority to consent to treatment, I also argue that inappropriate offers yield invalid consents. Considerations on inappropriate offers should therefore inform which kinds of CNS intervention-based rehabilitation schemes the state may propose as part of the criminal justice system. Yet as I conclude in this paper, while there are some intrinsic constraints on voluntary rehabilitation programs, the main constraints on voluntary rehabilitation are likely to be contingent overriders. However, CNS intervention is not ruled out as such in the context of voluntary rehabilitation. (shrink)

Informed consent is considered by many to be a moral imperative in medical research. However, it is increasingly acknowledged that in many actual instances of consent to participation in medical research, participants do not employ the provided information in their decision to consent, but rather consent based on the trust they hold in the researcher or research enterprise. In this article we explore whether trust-based consent is morally inferior to information-based consent. We analyse (...) the moral values essential to valid consent – autonomy, voluntariness, non-manipulation, and non-exploitation – and assess whether these values are less protected and promoted by consent based on trust than they are by consent based on information. We find that this is not the case, and thus conclude that trust-based consent if not morally inferior to information-based consent. (shrink)

I argue that valid informed consent is ethically required for organ donation from individuals declared dead using neurological criteria. Current policies in the U.S. do not require this and, not surprisingly, current practices inhibit the possibility of informed consent. Relevant information is withheld, opportunities to ensure understanding and appreciation are extremely limited, and the ability to make and communicate a free and voluntary decision is hindered by incomplete disclosure and other practices. Current practices should be (...) revised to facilitate valid informed consent for organ donation. (shrink)

BackgroundInformed consent is an ethical and legal requirement for research involving human participants. However, few studies have evaluated the process, particularly in Africa.Participants in a case control study designed to identify correlates of immune protection against tuberculosis (TB) in South Africa. This study was in turn nested in a large TB vaccine efficacy trial.The aim of the study was to evaluate the quality of consent in the case control study, and to identify factors that may influence the quality (...) of consent.Cross-sectional study conducted over a 4 month period.MethodsConsent was obtained from parents of trial participants. These parents were asked to complete a questionnaire that contained questions about the key elements of informed consent (voluntary participation, confidentiality, the main risks and benefits, etc.). The recall (success in selecting the correct answers) and understanding (correctness of interpretation of statements presented) were measured.ResultsThe majority of the 192 subjects interviewed obtained scores greater than 75% for both the recall and understanding sections. The median score for recall was 66%; interquartile range (IQR) = 55%–77% and for understanding 75% (IQR = 50%–87%). Most (79%) were aware of the risks and 64% knew that they participated voluntarily. Participants who had completed Grade 7 at school and higher were more likely (OR = 4.94; 95% CI = 1.57 – 15.55) to obtain scores greater than 75% for recall than those who did not. Participants who were consented by professional nurses who had worked for more than two years in research were also more likely (OR = 2.62; 95% CI = 1.35–5.07) to obtain such scores for recall than those who were not.ConclusionNotwithstanding the constraints in a developing country, in a population with low levels of literacy and education, the quality of informed consent found in this study could be considered as building blocks for establishing acceptable standards for public health research. Education level of respondents and experience of research staff taking the consent were associated with good quality informed consent. (shrink)