Historically the primary role of the Institutional Review Board (IRB) has been "to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in research" (U.S. FDA, 1996). However, there is much to suggest that IRBs have been unable to fulfil this mandate, particularly in regard to the matter of informed consent. Part of the problem in this regard is that the competing interests of (...) other stakeholders often undermine the IRB's capacity to serve the best interests of research subjects. This paper proposes an alternative view of the role of the IRB. It begins by treating the interests of other stakeholders as legitimate matters of concern for IRBs. Hence the process established to review and monitor human research should be treated as an exercise in social justice in which the interests of all legitimate stakeholders must be represented and considered. A variation of Rawls' (1971) heuristic "the veil of ignorance" is employed to explore the dynamic relationship between knowledge and interests that ensues when the role of the IRB is characterized in this manner. Inadequacies in the informed consent process are taken as illustrative of the inability of IRBs as they are presently construed to attend to the interests of research subjects. The major normative implication of the analysis offered here is that the role of the IRB must be expanded to include the granting of a provisional proxy consent on behalf of prospective research subjects. This provision is necessary, it is argued, if the interests of research subjects are to be fairly assessed by IRBs as a matter of social justice. It is necessary as well to ensure that an adequate standard of informed consent is attained. Somewhat paradoxically it is argued competing sets of interests the IRB must serve, rather than as the primary concern of the IRB. (shrink)

I discuss conditions for the validity of proxy consent to treatment on behalf of an incompetent person. I distinguish those incompetents who, when previously competent, expressed an opinion on the treatment in question from those who were never competent or who, though previously competent, never expressed an opinion on the proposed treatment. In the former case valid proxy consent usually requires respecting the stated wishes of the patient. The latter case is more difficult. I consider a (...) widely-held principle which appeals to the counterfactual wishes of the incompetent person. I argue that it is unacceptable and propose in its place a principle having to do with the best interests of the patient. Keywords: proxy consent, informed consent, competence, hypothetical wishes, substituted judgment, counterfactual wishes CiteULike Connotea Del.icio.us What's this? (shrink)

The prescription of practice guidelines for consent in neonatal care that are appropriate for all interventions faces substantial problems. Current practice varies widely. Consent in neonatal care is compromised by postnatal constraints on information sharing and decision-making. Empirical research shows marked individual and cultural variation in the degree to which parents want to contribute to decision-making on behalf of their infants. Conflict between the parents’ wishes and the infant’s best interests could arise if consent for a recommended (...) intervention were refused, and parental refusal of consent may have to be overridden. Consent to an appropriate package of care (such as special, intensive or palliative care) may be morally preferable to a universal requirement to seek consent for all individual interventions entailed by that package. (shrink)

People who are unable to make decisions about participating in research rely on proxies to make a decision based on their wishes and preferences. However, patients rarely discuss their preferences about research and proxies find it challenging to determine what their wishes would be. While the process of informed consent has traditionally been the focus of research to improve consent decisions, the more conceptually complex area of what constitutes ‘good’ proxy decision-making for research has remained unexplored. (...) Interventions are needed to improve and support proxy decision-making for research but are hampered by a lack of understanding about what constitutes decision quality in this context. A global increase in conditions associated with cognitive impairment such as dementia has led to an urgent need for more research into these conditions. The COVID-19 pandemic and subsequent necessity to conduct research with large numbers of critically ill patients has made this need even more pressing. Much of the empirical research centres on the desire to improve decision accuracy, despite growing evidence that authenticity is more reflective of the aim of proxy decisions and concerns about the methodological flaws in authenticity-focused studies. Such studies also fail to take account of the impact of decision-making on proxies, or the considerable body of research on improving the quality of healthcare decisions. This paper reports a concept synthesis of the literature that was conducted to develop the first conceptualisation of ‘good’ proxy decisions about research participation. Elements of decision quality were identified across three stages of decision-making: proxy preparedness for decision-making which includes knowledge and understanding, and values clarification and preference elicitation; the role of uncertainty, decisional conflict, satisfaction and regret in the decision-making process; and preference linked outcomes and their effect. This conceptualisation provides an essential first step towards the future development of interventions to enhance the quality of proxy decision-making and ensure proxy decisions represent patients’ values and preferences. (shrink)

Objective: To assess the knowledge of four groups of individuals regarding who is legally authorised to consent to health care or research involving older patients.Design: A provincewide postal survey.Setting: Province of Quebec, Canada.Participants: Three hundred older adults, 434 informal caregivers of cognitively impaired individuals, 98 researchers in aging and 136 members of research ethics boards .Measurements: Knowledge was assessed through a pretested postal questionnaire comprising five vignettes that describe hypothetical situations involving an older adult who requires medical care or (...) is solicited for research. The respondent had to identify the person who is legally authorised to provide consent.Results: Nearly 80% of all respondents provided the correct answer when the hypothetical scenario depicted a person who was competent to consent or incompetent but legally represented. Knowledge was worse for the scenario describing a research situation that involved an incompetent adult without a legal guardian.Conclusion: The observed lack of knowledge raises doubts about the ability of current legislation to truly protect the rights of older adults with diminished decision making capacity. It points to the need for educational programmes aimed at increasing public awareness of the legislation put in place for those requiring special protection. (shrink)

Informed consent is an essential requirement for the ethical conduct of research. It is also a necessary requirement for the lawful conduct of research. Informed consent provides a legal basis to enrol human subjects in clinical research. In paediatric research, where children do not generally enjoy a presumption of competence, a legal representative must authorise a child's enrolment. Determining who should act on behalf of the child is a matter of law, rather than ethical principle. But, (...) if national laws are lacking or do not reflect socio-cultural realities, legal uncertainty can arise, which can have implications for children's enrolment in clinical research. Using Thailand as its case study, this paper contemplates how international legal frameworks, such as the UN Convention on the Rights of the Child, could be leveraged to navigate legal uncertainty in the informed consent process, enabling more children to access and participate in paediatric clinical research. (shrink)

Equipoise is advocated as a means of achieving high scientific and ethical standards in randomised trials. As used in the context of research the word describes a state of uncertainty characterised by the belief that in a trial no arm is known to offer greater harm or benefit than any other arm. Clinicians who lack personal equipoise are advised to accept clinical or communal equipoise, based on current unresolved disagreement among the medical profession. Equipoise is mainly discussed in the literature (...) as an issue for senior doctors and research directors. Limitations of professional equipoise are reviewed, and data on the neglected topic of patients' equipoise are reported using the example of breast cancer trials. In theory, a patient who gives informed and voluntary consent to enter a randomised trial has achieved the equilibrium of equipoise. In practice, equipoise among patients ranges from personal to proxy acceptance. (shrink)

This paper considers the ethical issues raised by biobanking of material from children who are not mature enough to give ethically valid consent. The first part considers consent requirements for entry of such materials in the biobank, whereas the second part looks at the issues that arise when a competent child later wants to withdraw previously sored materials, and at the issues that arise when there is informational entanglement between information about a parent and information about a child. (...) The paper argues for three main conclusions:That it is in most cases acceptable for parents to give proxy consent to entry of material from their children ino biobanks, even though this is not strictly speaking in the best interest of the child;that a right to withdraw from the biobank is more important when material has been entered with proxy consent; andthat disputes about the withdrawal of entangled information, i.e. information that is both about a parent and a child, should be resolved in favour of the child. (shrink)

The legal basis of informed consent in Texas may on first examination suggest an unqualified affirmation of persons as the source of authority over themselves. This view of individuals in the practice of informed consent tends to present persons outside of any social context in general and outside of their families in particular. The actual functioning of law and medical practice in Texas, however, is far more complex. This study begins with a brief overview of the (...) roots of Texas law and public policy regarding informed consent. This surface account is then contrasted with examples drawn from the actual functioning of Texas law: Texas legislation regarding out-of-hospital do-not-resuscitate (DNR) orders. As a default approach to medical decision-making when patients lose decisional capacity and have failed to appoint a formal proxy or establish their wishes, this law establishes a defeasible presumption in favor of what the law characterizes as “qualified relatives” who can function as decision-makers for those terminal family members who lose decisional capacity. The study shows how, in the face of a general affirmation of the autonomy of individuals as if they were morally and socially isolated agents, space is nevertheless made for families to choose on behalf of their own members. The result is a multi-tier public morality, one affirming individuals as morally authoritative and the other recognizing the decisional standing of families. (shrink)

Background: Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment.Aim: To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials .Patients and methods: The study comprised two phases: the development of a questionnaire to assess the quality of informed consent and (...) a survey of patient subjects based on this questionnaire.Results: A total of 303 patient subjects or parent proxies were contacted and 279 questionnaires were analysed. The median age was 49.5 years, sex ratio was 1 and 61% of respondents were professionally active. Overall memorisation of the oral or written communication of informed consent was good , and satisfaction with the process was around 70%. Therapeutic misconception was present in 70% of respondents, who expected to receive better care and ignored the consequence of randomisation and treatment comparisons. This was positively associated with the acuteness and severity of the disease.Conclusion: The authors suggest that the risk of therapeutic misconception be specifically addressed in consent forms as an educational tool for both patients and investigators. (shrink)

To obtain reliable results, some psychological experiments need to involve the deception of human subjects. This contradicts the ethical principle of autonomy and the process of informed consent that is required to ensure the subjects’ autonomy. Some solutions to this dilemma have been proposed, but all of them have drawbacks. As solution I propose a procedure that combines proxy consent and prior consent.

The right to refuse medical intervention is well established, but it remains unclear how best to respect and exercise this right in life support. Contemporary ethical guidelines for critical care give ambiguous advice, largely because they focus on the moral equivalence of withdrawing and withholding care without confronting the very real differences regarding who is aware and informed of intervention options and how patient values are communicated and enacted. In withholding care, doctors typically withhold information about interventions judged too (...) futile to offer. They thus retain greater decision-making burden and face weaker obligations to secure consent from patients or proxies. In withdrawing care, there is a clearer imperative for the doctor to include patients in decisions, share information and secure consent, even when continued life support is deemed futile. How decisions to withhold and withdraw life support differ ethically in their implications for positive versus negative interpretations of patient autonomy, imperatives for consent, definitions of futility and the subjective evaluation of benefits and burdens of life support in critical care settings are explored. Professional reflection is required to respond to trends favouring a more positive interpretation of patient autonomy in the context of life support decisions in critical care. Both the bioethics and critical care communities should investigate the possibilities and limits of growing pressure for doctors to disclose their reasoning or seek patient consent when decisions to withhold life support are made. (shrink)

Background: Patients often are confronted with the choice to allow cardiopulmonary resuscitation (CPR) should cardiac arrest occur. Typically, informed consent for CPR does not also include detailed discussion about survival rates, possible consequences of survival, and/or potential impacts on functionality post-CPR. Objective: A lack of communication about these issues between providers and patients/families complicates CPR decision-making and highlights the ethical imperative of practice changes that educate patients and families in those deeper and more detailed ways. Design: This review (...) integrates disparate literature on the aftermath of CPR and the ethics implications of CPR decision-making as it relates to and is affected by informed consent and subsequent choices for code status by seriously ill patients and their surrogates/proxies within the hospital setting. Margaret Urban Walker’s moral philosophy provides a framework to view informed consent as a practice of responsibility. Ethical considerations: Given nurses’ communicative skills, ethos of care and advocacy, and expertise in therapeutic relationships, communication around DNAR decision-making might look quite different if institutional norms in education, healthcare, law, and public policy held nurses overtly responsible for informed consent in some greater measure. Findings: Analysis from this perspective shows where changes in informed consent practices are needed and where leverage might be exerted to create change in the direction of deeper and more detailed discussions about CPR survival rates and possible consequences of survival. (shrink)

The biblical healings by Jesus and the primitive Church, the liturgical development of the Roman Rite of Exorcism, and the current practice of exorcists reflect a relationship between exorcism and the medical healing arts. Since mutuality characterizes all healer–sufferer interactions, informed consent is a central concept in physician–patient and exorcist–energumen relationships. Informed consent requires adequate information, decision-maker competence, and freedom from coercion. The determination of freedom from coercion is a particular challenge in exorcism, and guidelines for (...) its assess­ment are discussed. While proxy decision making in medical care is generally driven by concerns over competence, foreseeable periods of demonic coercion will necessitate establishing proxies in exorcism. This places a moral duty on the exorcist to establish a substitute decision maker even in cases where the energumen would be considered competent. Discussion of this need through the process of informed consent builds the trust necessary for mutual decision making. (shrink)

The first principle of the Nuremberg Code requires the informed consent of the subject. Proxy consent was not addressed until the Declaration of Helsinki. U.S. policies regarding consent for the participation of children in research would not be finalized for almost two more decades in subpart D of the federal regulations that govern the participation of subjects in research. In October 2000, the Children's Health Act was passed. Title X required the Secretary of the Department (...) of Health and Human Services to conduct a review of the regulations under subpart D and “to consider any modifications necessary to ensure the adequate and appropriate protection of children participating in research, and report the findings of the Secretary to Congress.” In this article, I provide a brief overview of the current informed consent requirements in pediatric research, which include requirements for parental permission and the child's assent. I then examine the moral bases for these requirements; whether the current policies are consistent with these moral foundations; and if not, how the policies ought to be modified. a. (shrink)

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)

There is always a debate around consent in the context of research. Given the expansion of different approaches to qualitative research within dementia care, there is increasing consideration around consent in this context; particularly in research concerning the experiences of living with dementia and the care of persons with dementia. Specifically there is a drive to directly involve persons with dementia as they offer specific expertise concerning living with dementia. Additionally, capacity legislation strengthens the case for ensuring that (...) persons with dementia are actively enabled to make their own decisions for as long as possible. This paper discusses an approach and method that can enable more persons who are living with dementia to participate in some types of research should they want to. Currently, most researchers rely on an extension of the traditional competency-based informed consent method and/or proxy consent or assent. However, related to the development of so-called person-centred and participatory research in dementia, there are now a number of academic publications on approaches and practical methods of ‘inclusionary’ consent. This paper considers the broader contextual influences on inclusionary consent and outlines the key aspects of such approaches based on the development of one specific method for including persons with dementia in consent processes. The method is based on the premise that, for persons with a dementia, informed consent becomes increasingly redundant and consequently exclusionary to them as persons. And even where capacity is said to no longer exist, persons with dementia are often able to make choices and make known their preferences about participating in research where the consent process is made specifically dementia-sensitive. Ethics committees can facilitate researchers both by supporting them when they need to and want to include persons with dementia in gerontological research and by challenging them to ensure that participation is genuine and starts with process consent. (shrink)

Informed consent is a vital part of ethical research. In emergency health care research environments such as ambulance services and emergency departments, it is sometimes necessary to conduct trial interventions or observations without patient consent. At times where treatment is time critical, it may be impossible or inappropriate to seek consent from next of kin. Emergency medicine is one of the few areas where the process of informed consent can be waived to allow research (...) to proceed without patient consent. This article will explore the ethics of informed consent in the prehospital emergency research context. This will include an overview of current Australian guidelines for ethical research, and recent changes in law internationally which have affected the conduct of international emergency health research. An overview of the ethical reasoning behind the waiver of informed consent in emergency research is presented, also addressing issues relating to emergency health research such as proxy consent, unconscious patients, and patient decision making capacity. The unusual circumstances encountered in the prehospital ambulance environment will also be discussed, including the dependent and coercive relationship between patients and ambulance professionals, and a lack of alternatives for care and transport for patients who refuse consent. The conflict arising from differences in medical culture and values between patients and health care professionals will also briefly be discussed. It will be argued that, while emergency care research should not require informed consent due to the restrictions of time and dependent nature of the relationship between patient and health professional, emergency health researchers still have a responsibility to consider the patients’ perspective when considering the ethical issues of an emergency research project, particularly in the prehospital environment. (shrink)

Functional MRI shows promise as a candidate prognostication method in acutely comatose patients following severe brain injury. However, further research is needed before this technique becomes appropriate for clinical practice. Drawing on a clinical case, we investigate the process of obtaining informed consent for this kind of research and identify four ethical issues. After describing each issue, we propose potential solutions which would make a patient’s participation in research compatible with her rights and interests. First, we defend the (...) need for traditional proxy consent against two alternative approaches. Second, we examine the impact of the intensive care unit environment on the informed consent process. Third, we discuss the therapeutic misconception and its potential influence on informed consent. Finally, we deal with issues of timing in recruiting participants and related factors which may affect the risks of participation. (shrink)

This paper explores the dominant rational approach to informed consent and challenges the appropriateness of this approach to ethical decision‐making with people with dementia. In dementia care a dominant assumption exists that people are not autonomous because of their inability to make decisions and exercise freedom of choice. The rational understanding of autonomy being the capacity to exercise freedom of choice means that health and social care professionals feel justified in making decisions on behalf of the person with (...) dementia. If a person cannot consent to an intervention then a proxy is used to make the decision. This paper argues that such an approach reinforces the mind‐body dualism that dominates health and social care discourse. Whilst acknowledging the place of proxy decision‐making, it is argued that there is a need to hear the voice of the person with dementia that goes beyond rational understandings of what is heard and that does not reinforce separation of the mind and body. An understanding of the person through their ‘narrative identity’ is proposed and illustrated through a case example. Drawing on the philosophy of Ricoeur it is argued that an individual's narrative identity can be developed and used to underpin informed consent decisions. Using a case example it is argued that paying attention to an individual's narrative identity provides a way of respecting the autonomy of the individual with dementia in a way that is consistent with their overall life plan. (shrink)

Informed consent to breaking (or waiving) bad news is an important yet neglected topic. It is distinct from informed consent to diagnosis and to treatment, and may be logically and ethically sound, provided patients are competent and that no considerable harm may be caused to others by breaking or waiving bad news to patients. This requires a differential assessment procedure in order to balance patient autonomy, benefit and justice towards others, preferably exploring patients’ values, expectations and (...) needs with them, so that an acceptable decision can be made on whether to act on their consent to breaking or waiving bad news, or to ignore it and act on informed consent by proxy. Future study should attempt to provide a detailed characterization of procedures for attaining informed consent to breaking or waiving bad news, and to test their success in establishing ethically sound health care. (shrink)

The meaning of valid proxy consent for children has recently been the subject of an important debate between Richard McCormick and Paul Ramsey on the ethics of experimenting with children. Ramsey is willing to agree with McCormick that parental consent for a child to undergo some medical procedure is valid only if parents consider what the child would consent to if he could. But beyond this, Ramsey has a fundamentally different conception of the child from McCormick, (...) and therefore gives a very different interpretation to this standard for valid proxy consent. In Ramsey's view, McCormick's basic mistake is to think of the child as a small adult, thereby overlooking the child's peculiar vulnerabilities and needs. In particular, McCormick fails to attend to the child's needs for "preservation in life and healthful growth". In this paper, the author pursues Ramsey's suggestion that a correct analysis of valid proxy consent for children would replace the "language of consent" with the "language of need". He does this by sketching a theory of parenthood that rests on two central notions: that of primary goods, as found in the writing of John Rawls, and that of autonomy. (shrink)

Alzheimer’s disease is the most common form of dementia which is estimated to impact 350,000 people over 65 years of age in Canada. The lack of effective treatment and the growing number of people who are expected to be diagnosed with Alzheimer’s disease in the near future are compelling reasons why continued research is in this area is necessary. With additional research, there needs to be greater recognition of the complexity of seeking ongoing informed consent from those with (...) Alzheimer’s disease. This complexity is because the impairment of memory and cognitive ability does not diminish in a linear manner, but rather fluctuates between periods of impairment and relatively normal cognitive lucidness. There is limited discussion in the guidelines of those progressing from early stages of Alzheimer’s disease who have intermittent cognitive function. Guidelines to research and Research Ethics Boards require further development to facilitate researcher including those with Alzheimer’s disease while protecting this growing pool of potential participants. (shrink)

The use of cochlear implants in born-deaf infants addresses the issues of disability, proxy consent, and potential ethnocide of the Deaf culture. The ethical issues explored in this paper are: 1) the disability versus trait argument of deafness, 2) parents versus Deaf community in proxy consent, 3) justification for surgical intervention in a non-life threatening condition, and 4) justification for ethnocide. Decisions for non-competent individuals should be made to assure the child of an open future, with (...) rights that need to be protected now, so that the child can exercise them later as an adult. Cochlear implants provide the potential of an open future and are morally justified on that basis. (shrink)

This essay explores the plausibility of attempting to justify the imposition of risk on young children, in the course of therapeutic treatment or nontherapeutic research, by an appeal to proxy consent. In particular, Richard McCormick's reliance on this type of defense is examined and rejected, and an alternative basis for determining the justifiability of such treatment is partially sketched – one which avoids any attempt to ‘construct’ consent on the part of the child. CiteULike Connotea Del.icio.us What's (...) this? (shrink)

Informed consent, when given by proxy, has limitations: chiefly, it must be made in the interest of the patient. Here we critique the standard approach to parental consent, as present in Canada and the UK. Parents are often asked for consent, but are not given the authority to refuse medically beneficial treatment in many situations. This prompts the question of whether it is possible for someone to consent if they cannot refuse. We present two (...) alternative and philosophically more consistent frameworks for paediatric proxy consent. The first allows meaningful consent (parents may say ‘yes’ or ‘no’ to treatment), provided that parents are medically informed/competent and intend the health and well-being of their child. In the second solution, medical practitioners or the state consent for treatment, with parents only being consulted to help give insight to the child’s circumstances. While we contend that either of these two options is superior to the insincerity of the present paradigm, we suggest that the first solution is preferable. (shrink)

Background Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet, approaching the parents of these infants at such a difficult time raises challenges to obtaining valid informed consent for such research. In this study, we asked, What light does the analytical literature cast on an ethically defensible approach to obtaining informed consent in perinatal clinical trials? -/- Methods In a systematic search, we (...) identified 30 studies. We began our analysis by applying philosophical frameworks, which were then refined as concepts emerged from the analytical studies, to present a coherent picture of a broad literature. -/- Results Between them, the studies addressed four themes. The first three were the ethical basis for parental informed consent for neonatal and/or perinatal research, the validity of parental consent in this context, and the range of possible options in methods for gaining consent. The last was the issue of risk and the possibility of a double-standard or asymmetry in the current approaches to the requirement for consent for research and consent for clinical treatment. -/- Conclusions In addressing these issues, the analysed studies showed that, whilst there are a variety of possible defences for seeking parental ‘consent’ to neonatal and/or perinatal clinical trials, these are all consistent with the strongly and widely held view that it is important that parents do give (or decline) consent for such research. So far as the method of obtaining consent is concerned, none of the existing consent processes reviewed by the research is satisfactory, and there are philosophical reasons for supposing that at least some parents will fail to give valid consent in a neonatal context. Furthermore, in giving parental ‘consent’ in a perinatal context, parents are authorising infant participation, not giving ‘proxy consent’. Finally, there are reasons for giving weight to both parental ‘consent’ and the infant’s best interests in both research and clinical treatment. However, there are also reasons to treat these factors differently in the two contexts, and this may be partly due to the differing relevance of risk in each case. A significant gap is the lack of any detailed discussion of a process of emergency and/or urgent ‘assent’, in which parents assent or refuse their baby’s participation as best they can during the emergency and later give full consent to continuing participation and follow-up. (shrink)

Six people were interviewed about the possibility of becoming posthumous body donors. Interview transcripts were analyzed using interpretative phenomenological analysis. Individual-level analysis suggested a common interest in Personhood Concerns and a common commitment to Enlightenment Values. Investigations of these possible themes across participants resulted in identification of two sample-level themes, each with two subthemes: Autonomy, with subthemes of agency and consent, and Rationality, with subthemes of knowledge/epistemology and materialism/ontology. This paper concentrates on the former. Consent for posthumous body (...) donation was felt to sometimes fall short of adequately identifying donors’ preferences about what happened after consent was given, even with respect to actions for which consent established permission. In turn, paucity of information about donors’ preferences limited others’ ability to act as proxy agents to facilitate donors’ posthumous autonomy. Thus, while consent may curtail violations of people’s autonomy by authorizing actions for which permission has been established, it may fall short of facilitating their autonomy in ways that might be possible with greater knowledge of those people’s desires. Alternative methods of establishing consent are explored that might better-determine people’s desires and thereby improve others’ ability to act as proxy agents for them to facilitate their subsequent (even posthumous) autonomy. (shrink)

Objectives: To investigate whether different methods of obtaining informed consent affected recruitment to a study of delirium in older, medically ill hospital inpatients.Design: Open randomised study.Setting: Acute medical service for older people in an inner city teaching hospital.Participants: Patients 70 years or older admitted to the unit within three days of hospital admission randomised into two groups.Intervention: Attempted recruitment of subjects to a study of the natural history of delirium. This was done by either a formal test of (...) capacity, followed by either a request for consent or an attempt at obtaining assent from a proxy, or a combined informal capacity/consent process.Main outcome measures: Prevalence and severity of delirium, and, as case mix measures, length of hospital stay and destination on discharge.Results: Recruitment of subjects through establishing formal capacity and then informed consent was less successful and, compared with those recruited through the usual combined capacity/consent approach, yielded a sample with less cognitive impairment, lower severity of delirium, lower probability of case note diagnosis of delirium and lower rate of entering a care home.Conclusions: Methods of obtaining informed consent may significantly influence the case mix of subjects recruited to a study of delirium. Stringent testing of capacity may exclude patients with delirium from studies, thus rendering findings less generalisable. A different method is necessary to achieve an ethical balance between respecting autonomy through obtaining adequate informed consent and avoiding sample bias. (shrink)

Surrogate (proxy) decision makers must make research decisions for people with dementia who lack decision-making capacity. Proxies’ decision-making processes are minimally understood. We randomly assigned 82 proxies of AD patients to informed consent for one of three hypothetical protocols with differing levels of risk and benefit. Proxies answered questions about potential benefits of the described research to the patient and society, as well as about whether they would enroll their relative and why or why not. Proxies interested (...) in enrolling their relative cited the potential for direct benefit to their relative, altruism, and trust in researchers. Those declining cited risks, inconvenience, and stage of illness. Proxies weighed numerous factors, incorporating both substituted judgment and best interests standards in their decision-making processes. Although further empirical work is needed to understand the influences on and adequacy of proxies’ decision making regarding research, these findings can help inform policy regarding surrogate consent. (shrink)

When patients are in vegetative states and their lives are maintained by medical devices, their surrogates might offer proxy consents on their behalf in order to terminate the use of the devices. The so-called ’substituted judgment thesis’ has been adopted by the courts regularly in order to determine the validity of such proxy consents. The thesis purports to evaluate proxy consents by appealing to putative counterfactual truths about what the patients would choose, were they to be competent. (...) The aim of this paper is to reveal a significant limitation of the thesis, which has hitherto been recognised only vaguely and intuitively. By appealing to the metaphysics of counterfactuals I explain how the thesis fails to determine the validity of proxy consents in a number of actual cases. (shrink)

Objectives: Efficient procedures for obtaining informed (proxy) consent may contribute to high influenza vaccination rates in nursing homes. Yet are such procedures justified? This study’s objective was to gain insight in informed consent policies in Dutch nursing homes; to assess how these may affect influenza vaccination rates and to answer the question whether deviating from standard informed consent procedures could be morally justified. Design: A survey among nursing home physicians. Setting & Participants: We (...) sent a questionnaire to all (356) nursing homes in the Netherlands, to be completed by one of the physicians. Results: We received 245 completed questionnaires. As 21 institutions appeared to be closed or merged into other institutions, the response was 73.1% (245/335). Of all respondents 81.9% reported a vaccination rate above 80%. Almost 50% reported a vaccination rate above 90%. Most respondents considered herd immunity to be an important consideration for institutional policy. Freedom of choice for residents was considered important by almost all. Nevertheless, 106 out of 245 respondents follow a tacit consent procedure, according to which vaccination will be administered unless the resident or her proxy refuses. These institutions show significantly higher vaccination rates (p < 0.03). Conclusions: In our discussion we focus on the question whether tacit consent procedures can be morally justifiable. Such procedures assume that vaccination is good for residents either as individuals or as a group. Even though this assumption may be true for most residents, there are good reasons for preferring express consent procedures. (shrink)

Background The use of lengthy, detailed, and complex informed consent forms is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to (...) participate in biomedical research. Methods This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 to 5. Results Of the 2484 questionnaires distributed, 2113 were returned. The majority of respondents considered most elements required in the ICF to be ‘moderately important’ to ‘very important’ for their decision making. Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF. Conclusions Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF. (shrink)

In this article, we seek to contribute to the debate on the requirement of disclosure in the context of informed consent for research. We defend the subjective standard of disclosure and describe ways to implement this standard in research practice. We claim that the researcher should make an effort to find out what kinds of information are likely to be relevant for those consenting to research. This invites researchers to take empirical survey information seriously, attempt to understand the (...) cultural context, talk to patients to be better able to understand what can be potentially different concerns and interests prevalent in the target population. The subjective standard of disclosure should be seen as a moral ideal that perhaps can never be perfectly implemented but still can and should be used as a normative ideal guiding research practice. In the light of these discussions, we call for more empirical research on what considerations are likely to be perceived as relevant by potential research participants recruited from different socio-economic and cultural groups. (shrink)

BackgroundConsent for data research in acute and critical care is complex as patients become at least temporarily incapacitated or die. Existing guidelines and regulations in the European Union are of limited help and there is a lack of literature about the use of data from this vulnerable group. To aid the creation of a patient-centred framework for responsible data research in the acute setting, we explored views of patients and next-of-kin about the collection, storage, sharing and use of genetic and (...) health-related data for observational research.MethodsWe conducted qualitative interviews (n = 19) with Dutch sudden cardiac arrest survivors who donated clinical and socio-economic data and genetic samples to research. We also interviewed their next-of-kin. Topics were informed by ethics literature and we used scenario-sketches to aid discussion of complex issues.ResultsSudden cardiac arrest survivors displayed limited awareness of their involvement in health data research and of the content of their given consent. We found that preferences regarding disclosure of clinically actionable genetic findings could change over time. When data collection and use were limited to the medical realm, patients trusted researchers to handle data responsibly without concern for privacy or other risks. There was no consensus as to whether deferred consent should be explicitly asked from survivors. If consent is asked, this would ideally be done a few months after the event when cognitive capacities have been regained. Views were divided about the need to obtain proxy consent for research with deceased patients’ data. However, there was general support for the disclosure of potentially relevant post-mortem genetic findings to relatives.ConclusionsSudden cardiac arrest patients’ donation of data for research was grounded in trust in medicine overall, blurring the boundary between research and care. Our findings also highlight questions about the acceptability of a one-time consent and about responsibilities of patients, researchers and ethics committees. Finally, further normative investigation is needed regarding the (continued) use of participants’ data after death, which is of particular importance in this setting. Our findings are thought to be of relevance for other acute and life-threatening illnesses as well. (shrink)

The paper clarifies the relative merits and proper roles of standards of review in the determination of proxy consent for those unable to make decisions concerning their own medical treatment. The "substituted judgment" standard asks which treatment the incompetent person would choose if competent, while the "best interests" test asks which treatment would benefit the patient. The tests are discussed in relation to the moral principles of autonomy and beneficence which provide their justification. I distinguish six types of (...) cases involving incompetent patients and argue that which standard is appropriate depends on the type of case involved. A "rational choice" standard, which asks "What would the incompetent patient choose if his or her choice were rational?", is proposed as a way of determining best interests. Keywords: proxy consent, nontreatment of incompetent persons, substituted judgment CiteULike Connotea Del.icio.us What's this? (shrink)

Objectives: To gather information about the practices and attitudes of providers of maternity care with respect to informed consent for newborn screening .Methods: A questionnaire concerning information provision and parental consent for NBS was sent to all 1036 registered lead maternity carers in New Zealand.Results: 93% of LMC in New Zealand report giving parents information concerning NBS, most frequently after delivery and in the third trimester . The majority of LMC currently obtain some form of consent (...) for NBS from parents and consider this to be the ideal approach . Despite this a significant minority of LMC reported considering that NBS should be mandatory. Of those in our survey who believed that NBS should be mandatory, paradoxically most still believed that some form of parental consent should be obtained; of those who believed testing should not be mandatory, only a small proportion would accept parental refusal without question.Conclusions: When the results of this survey are considered in conjunction with existing evidence there appears to be a consensus that good quality information in the prenatal period should be an integral part of any NBS programme. The issue of consent is more complex and there is less agreement on the preferred degree of parental involvement in decisions to allow babies to undergo NBS. A policy that both strongly recommends NBS but also allows parental choice appears to be most consistent with the views of LMC in this survey. (shrink)

BackgroundThis study aimed to determine the elements and the extent of information that child participants and their parents would like to read in an informed assent form /informed consent form of a pediatric drug trial.MethodsA descriptive survey was conducted to determine the perceived importance of each element of the ICF content from child participants and their parents who underwent informed assent/consent of a multi-center pediatric drug trial. The respondents were asked to indicate the level of (...) importance of each item in a questionnaire, by giving a rating scale from 1 to 5.ResultsA total of 22 families, 17 child participants with the diagnosis of hematology or oncology diseases and 27 parents, were enrolled. Among 30 items, risk–benefit aspects were perceived to be of most concerning items from both child participants’ and parents’ viewpoint. None of the items were considered ‘slightly important’ or lower by more than 20% of the respondents.ConclusionsFor pediatric drug trials, risk–benefit information should be made a salient feature of an IAF/icf. This empirical data could help related stakeholders arrange essential information in order of importance and tailor an IAF/icf to better suit child participants’ and parents’ needs, particularly for pediatric drug trials involving children with the diagnosis of hematology or oncology diseases. (shrink)

Although there is consensus on the fact that ionizing radiation used in radiological examinations can affect health, the stochastic nature of risk makes it difficult to anticipate and assess specific health implications for patients. The issue of radiation protection is peculiar as any dosage received in life is cumulative, the sensitivity to radiation is highly variable from one person to another, and between 20 % and 50 % of radiological examinations appear not to be necessary. In this context, one might (...) reasonably assume that information and patient consent would play an important role in regulating radiological practice. However, there is to date no clear consensus regarding the nature and content of—or even need for—consent by patients exposed to ionizing radiation. While law and ethics support the same principles for respecting the dignity of the person, in the context of radiology practice, they do not provide a consistent message to guide clinical decision-making. This article analyzes the issue of healthcare professionals’ duty to inform and obtain patient consent for radiological examinations. Considering that both law and ethics have as one of their aims to protect vulnerable populations, it is important that they begin to give greater attention to issues raised by the use of ionizing radiation in medicine. While the situation in Canada serves as a backdrop for a reflective analysis of the problem, the conclusions are pertinent for professional practice in other jurisdictions because the principles underlying health law and jurisprudence are fairly general. (shrink)

Abstractabstract:Recent clinical trials of psychedelic drugs aim to treat a range of psychiatric conditions in adults. MDMA and psilocybin administered with psychotherapy have received FDA designation as "breakthrough therapies" for post-traumatic stress disorder (PTSD) and treatment-resistant depression (TRD) respectively. Given the potential benefit for minors burdened with many of the same disorders, calls to expand experimentation to minors are inevitable. This essay examines psychedelic research conducted on children from 1959 to 1974, highlighting methodological and ethical flaws. It provides ethics and (...) policy recommendations for psychedelics research involving children and adolescents, including recognizing that the psychedelic experience is an ineffable one that makes informed proxy consent for parents, guardians, and others especially challenging. Psychedelic experiences are associated with novel benefits and risks, such as significant personality changes, shifts in fundamental values, and possible re-exposure to traumatic memories. These effects may alter the process of personality development in minors. Recommendations for ethically sound psychedelics research in minors include strict adherence to eligibility criteria, including a comprehensive family and individual psychiatric, substance use, and trauma history. An age-appropriate assent process that includes considerations related to the use of therapeutic touch should be developed. In addition, oversight by data safety monitoring boards and patient and family advocates, coupled with the adoption of pharmacoequity best practices, will help to ensure safety and fairness of psychedelics research in children. (shrink)

The Mental Capacity Act 2005 has provided unified scope in the British medical system for proxy consent with regard to medical decisions, in the form of a lasting power of attorney. While the intentions are to increase the autonomous decision making powers of those unable to consent, the author of this paper argues that the whole notion of proxy consent collapses into a paternalistic judgement regarding the other person’s best interests and that the new legislation (...) introduces only an advisor, not a proxy with the moral authority to make treatment decisions on behalf of another. The criticism is threefold. First, there is good empirical evidence that people are poor proxy decision makers as regards accurately representing other people’s desires and wishes, and this is therefore a pragmatically inadequate method of gaining consent. Second, philosophical theory explaining how we represent other people’s thought processes indicates that we are unlikely ever to achieve accurate simulations of others’ wishes in making a proxy decision. Third, even if we could accurately simulate other people’s beliefs and wishes, the current construction of proxy consent in the Mental Capacity Act means that it has no significant ethical authority to match that of autonomous decision making. Instead, it is governed by a professional, paternalistic, best-interests judgement that undermines the intended role of a proxy decision maker. The author argues in favour of clearly adopting the paternalistic best-interests option and viewing the proxy as solely an advisor to the professional medical team in helping make best-interests judgements. (shrink)

A literature search was conducted on studies of new drugs used with patients with schizophrenia reported by U.S. and non-U.S. researchers from 1966–1993, yielding 41 U.S., and a total of 24 other non-U.S. studies, among them 11 British studies. Results of the U.S. and non-U.S. studies were pooled separately and compared. Among several comparable conditions discussed, the lack of any data on suicides in the U.S. studies was observed. For a second statistical analysis of suicide rates ‘person-years’ were calculated to (...) adjust for differing washout durations. The results obtained include findings that the percentage of patients relapsing in U.S. studies was slightly lower than in non-U.S. studies ; the percentage of patients dropping out in U.S. studies was higher than in non-U.S. studies ; known location of dropout patients in U.S. studies was 1.7%, compared to 2.6% in non-U.S. studies. The most interesting finding was that no suicides were reported in U.S. studies, compared to 0.6% of patients reported in British studies. Some U.S. studies used ‘challenge doses’, such as amphetamines or L-dopa; no non-U.S. studies reported their use. Compared to U.S. studies, those by non-U.S., and particularly British, researchers appeared to report adverse events in their studies. ‘Challenge’ drugs were not used; suicides were reported. It is estimated that the probability that no patients suicided who participated in the U.S. is small—one in 500. (shrink)

The mission of the Indian Health Service affects what research is done and how It is reviewed and managed and in turn affects the forms and process used to obtain informed consent. Consent forms must be Informative and understandable to American Indian and Alaska Native potential volunteers; the process used to obtain informed consent must minimize any institutional pressure to participate. The IHS Institutional Review Boards developed seven research Model Volunteer Consent Forms.

Severe Traumatic Brain Injury (TBI) remains a major cause of death and disability afflicting mostly young adult males and elderly people, resulting in high economic costs to society. Therapeutic approaches focus on reducing the risk on secondary brain injury. Specific ethical issues pertaining in clinical testing of pharmacological neuroprotective agents in TBI include the emergency nature of the research, the incapacity of the patients to informed consent before inclusion, short therapeutic time windows, and a risk-benefit ratio based on (...) concept that in relation to the severity of the trauma, significant adverse side effects may be acceptable for possible beneficial treatments. Randomized controlled phase III trials investigating the safety and efficacy of agents in TBI with promising benefit, conducted in acute emergency situations with short therapeutic time windows, should allow randomization under deferred consent or waiver of consent. Making progress in knowledge of treatment in acute neurological and other intensive care conditions is only possible if national regulations and legislations allow waiver of consent or deferred consent for clinical trials. (shrink)

Informed consent is medico-legal orthodoxy and the principal means by which research encounters with the body are regulated in the UK. However, biomedical advancements increasingly frustrate the degree to which informed consent can be practiced, whilst introducing ambiguity into its legal significance. What is more, feminist theory fundamentally disrupts the ideologically liberal foundations of informed consent, exposing it as a potentially inadequate mode of bioethical regulation. This paper explores these critiques by reference to a (...) case study—embryo donation to health research, following fertility treatment, as regulated by the HFEA 1990—and contends that informed consent cannot adequately respond to the material realities of this research encounter. Thereafter, by drawing on feminist theories of vulnerability, this paper proffers an alternative bioethical approach, which calls for structural reform in recognition of the fundamentally bilateral constitution of self and society and a renewed appreciation for the affective/dispositional tenor of lived experience. (shrink)

BackgroundUse of modified texture diets—thickening of liquids and modifying the texture of foods—in the hope of preventing aspiration, pneumonia and choking, has become central to the current management of dysphagia. The effectiveness of this intervention has been questioned. We examine requirements for a valid informed consent process for this approach and whether the need for informed consent for this treatment is always understood or applied by practitioners.Main textValid informed consent requires provision of accurate and (...) balanced information, and that agreement is given freely by someone who knows they have a choice. Current evidence, including surveys of practitioners and patients in different settings, suggests that practice in this area is often inadequate. This may be due to patients’ communication difficulties but also poor communication—and no real attempt to obtain consent—by practitioners before people are ‘put on’ modified texture diets. Even where discussion occurs, recommendations may be influenced by professional misconceptions about the efficacy of this treatment, which in turn may poison the well for the informed consent process. Patients cannot make appropriate decisions for themselves if the information provided is flawed and unbalanced. The voluntariness of patients’ decisions is also questionable if they are told ‘you must’, when ‘you might consider’ is more appropriate. Where the decision-making capacity of patients is in question, inappropriate judgements and recommendations may be made by substitute decision makers and courts unless based on accurate information.ConclusionResearch is required to examine the informed consent processes in different settings, but there is ample reason to suggest that current practice in this area is suboptimal. Staff need to reflect on their current practice regarding use of modified texture diets with an awareness of the current evidence and through the ‘lens’ of informed consent. Education is required for staff to clarify the importance of, and requirements for, valid informed consent and for decision making that reflects people’s preferences and values. (shrink)

Emergency medicine research requires the enrollment of subjects with varying decision-making capacities, including capable adults, adults incapacitated by illness or injury, and children. These different categories of subjects are protected by multiple federal regulations. These include the federal Common Rule, the Department of Health and Human Services (DHHS) regulations for pediatric research, and the Food and Drug Administration's (FDA) Final Rule for the Exception from the Requirements of Informed Consent in Emergency Situations. Investigators should be familiar with the (...) relevant federal research regulations to optimally protect vulnerable research subjects, and to facilitate the institutional review board (IRB) review process. IRB members face particular challenges in reviewing emergency research. No regulations exist for research enrolling incapacitated subjects using proxy consent. The wording of the Final Rule may not optimally protect vulnerable subjects. It is also difficult to apply conflicting regulations to a single study that enrolls subjects with differing decision-making capacities. This article is intended as a guide for emergency researchers and IRB members who review emergency research. It reviews the elements of Federal Regulations that apply to consent, subject selection, privacy protection, and the analysis of risks and benefits in all emergency research. It explores the challenges for IRB review listed above, and offers potential solutions to these problems. (shrink)

The number of admissions to hospitals of patients without a proxy decision maker is rising. Very often these patients need fairly immediate medical intervention for which informed consent—or informed refusal—is required. Many have recommended that there be a process in place to make these decisions, and that it include a variety of perspectives. People are particularly wary of relying solely on medical staff to make these decisions. The University Hospitals Case Medical Center recruits community members from (...) its Ethics Committee to serve on a subcommittee, the Patients Without Proxies (PWP) Committee, which works with medical staff during the decision-making process for these patients. Generally, the community members go to the bedside to observe patients. This article looks at how those unused to observing hospitalized patients who are sick and/or dying are affected, comparing them to mock jurors in a research study who are exposed to graphic photographs related to a fabricated crime scene. Judgments made by the mock jurors are affected by viewing such images. The personal experience of witnessing unfamiliar and shocking scenes affects their subsequent judgments. While it may be difficult to tease out whether observing patients causes PWP members to be benefited or harmed, they are affected by what they see. If a variety of perspectives is desirable to reduce possible bias or error, this article argues that at least one community member should refrain from seeing the patient in order to add a different and valuable voice to the decision-making process. Members of the subcommittee base their judgments on the various kinds of information available. Sometimes the things they see, hear, or feel may affect them particularly deeply, and affect their judgments as well. In this article I explore the idea that something like this may be happening in a particular kind of clinical ethics case consultation. (shrink)