The traditional common consent argument for the existence of God has largely been abandoned—and rightly so. In this paper, I attempt to salvage the strongest version of the argument. Surprisingly,...

A popular introduction to common consent arguments for belief in God.

The common consent argument claims that widespread belief in God is good evidence for God’s existence. Though taken seriously throughout the history of philosophy, the argument died in the 1800s. Our philosophy of religion textbooks ignore it. In this paper, we hope to resuscitate it drawing upon the demographics of religious belief, the cognitive science of religion, and contemporary epistemology. We develop and defend two common consent arguments, which maintain that widespread belief in a High God (...) is good evidence for theism over metaphysical naturalism. (shrink)

In this paper, I will explain and motivate the common consent argument for theism. According to the common consent argument it is rational for you to believe that God exists because you know so many other people believe that God exists. Having motivated the argument, I will explain and motivate several pressing objections to the argument and evaluate their probative force. The paper will serve as both an accessible introduction to this argument as well as a (...) resource for continued research on the topic. (shrink)

various arguments for the existence of God have risen and fallen over the centuries, but the one that has perhaps fallen furthest is the argument from the universal consent of mankind. Put simply, the argument went as follows: near enough everyone, in near enough every nation, in near enough every historical era, has believed in God; therefore, God must exist. Or, as it was summarized in the strikingly Lincolnesque terms of Diderot’s Encyclopédie: “You can fool some of the people, (...) or fool all of them in certain places and certain times, but not all people in all places and in all ages.”1 Universal agreement in the truth of a certain proposition was taken by many as a sufficient demonstration of that truth. This.. (shrink)

The need to protect the public against the spread of communicable disease provides a good example of the need for a commonsense approach to the use of confidential data. Laboratories need to notify different professionals in order to trace the sources of outbreaks of infection and eradicate the cause. It is often not possible to obtain consent from individual patients, given the rapid time scale required. In doing so, however, laboratory staff and others would contravene the Data Protection Act (...) in passing on information without consent. Section 60 of the Health and Social Care Act was designed to overcome barriers to research relying on data accumulated in the past and this type of public health work. But this is proving a sluggish procedure. It is an awkward solution to the problem of data use without specific consent. This problem will be overcome only when the public can have sufficient trust in safeguards that are in place to protect their safety and confidentiality so that these important activities can be pursued without specific informed consent. (shrink)

Until recently, epistemology was largely caught in the grips of an epistemically unrealistic radical epistemological individualism on which the beliefs and testimony of others were of virtually no epistemic significance. Thankfully, epistemologists have bucked the individualist trend, acknowledging that one person's belief or testimony that P might offer another person prima facie epistemic reasons – or social evidence as I call it – to believe P. In this paper, I discuss the possibility and conditions under which beliefs and testimony act (...) as social evidence, in particular, beliefs and testimony regarding the existence of God. The epistemic egoist maintains that one must possess positive reasons in favor of other people's reliability or trustworthiness before their beliefs and testimony offer prima facie social evidence. The epistemic universalist, on the other hand, argues that the beliefs of all others are prima facie credible and should be treated accordingly. All this will set up subsequent discussion of the epistemic significance of common consent or widespread belief in God. I show how common consent arguments assume the epistemic universalist's account of the conditions under which the beliefs and testimony of others acquire reason-giving force as social evidence. (shrink)

Laura Odwazny and Benjamin Berkman have raised several challenges regarding the new reasonable person standard in the revised Common Rule, which states that in‐ formed consent requires potential research subjects be provided with information a reasonable person would want to know to make an informed decision on whether to participate in a study. Our aim is to offer a response to the challenges Odwazny and Berkman raise, which include the need for a reasonable person standard that can be (...) applied consistently across institutional review boards and that does not stigmatize marginal groups. In response, we argue that the standard ought to be based in an ordinary rather than ideal person conception of reasonable person and that the standard ought to employ what we call a liberal constraint: the reasonability standard must be malleable enough such that a wide variety of individuals with different, unique value systems would endorse it. We conclude by suggesting some of the likely consequences our view would have, if adopted. (shrink)

The institutionalization of systems of informed consent in market economies has exaggerated rather than minimized the meritocractic effect of such economies. In developing economies, it may help reduce both inherent economic gaps and effects of inherited wealth. In both cases, the highest paid people are those whose performances evidence the highest hierarchical complexity, and lowest paid people have the lowest stages of performance. Society is stratified according to stage of performance. Postformal thought is more likely to develop in graduate (...) level education. Higher education has the effect of further stratifying individuals by stage of performance, rather than equalizing opportunity. (shrink)

The principle of informed consent, codified in the Declaration of Helsinki, has been widely seen as fundamental to bio-medical and research ethics. The importance of informed consent is increasing in procedures regulating the acquisition, possession and use of personal information, including genetic and medical information. Informed consent, it is believed, ensures that patients and research subjects can decide autonomously whether to permit or refuse actions that affect them. In response to this assurance, there are numerous guidelines at (...) local, national and international levels that recognise the importance of informed consent, especially in research related to healthcare in developing countries. However, complications arise in applying these guidelines to a particular situation, especially under conditions that are prevalent in developing societies, for instance in India. This article discusses common forms of impediments or hindrances encountered while exercising the principles of informed consent in the context of genetic and genomics related research among the tribal and rural caste communities in India. These hindrances include: illiteracy, poverty, paternalistic attitudes, socio-cultural barriers, ineffective regulatory mechanism and procedural inconsistency among others. The data used in this article is based on an ethnographic study conducted between December 2006 and May 2007 using social-science qualitative research techniques. We observe that three areas require attention: first, the ways in which informed public debate on bioethical issues can be held, and how the application of genetics and genomics in Indian society can be discussed; second, the readiness with which researchers, IRB members and the state appreciate and wish to map the genetic diversity in Indian society; and, third, the risks associated with the application of bioethical principles at a micro-level. (shrink)

Cluster randomised trials are an increasingly important methodological tool in health research but they present challenges to the informed consent requirement. In the relatively limited literature on the ethics of cluster research there is not much clarity about the reasons for which seeking informed consent in cluster randomised trials may be morally challenging. In this paper, I distinguish between the cases where informed consent in cluster trials may be problematic due to the distinct features of ‘population-based’ interventions, (...) which have not been adequately discussed in the research ethics literature, and the cases where informed consent may be problematic for reasons that investigators also encounter in other research designs. I claim that informed consent requirements in cluster trials should be adjusted to the level of risk involved, arguing for a more comprehensive notion of research risk than that currently found in the research ethics guidelines, and the amount of freedom to be sacrificed in relation to a particular research aim. I conclude that these two factors are the most important to consider when assessing whether a cluster study should proceed when informed consent is infeasible or difficult to obtain. (shrink)

There is substantial published evidence showing that countless people enroll each year in ethically deficient clinical trials. Many of the trials are problematic because the quality of the science used to justify their launch may not be sufficiently vetted while many other trials may lack requisite social value. This poses the question: why do people volunteer for them? The answer resides in large part in the fact that informed consent practices have historically masked, rather than disclosed, the information that (...) would alert research candidates to the ethically problematic nature of the trials. The “reasonable person” and “key information” provisions in the revised US Common Rule create the opportunity to correct this historical shortcoming. Two sources are employed to shed light on what the “key information” is that should be disclosed to a “reasonable person”: the original disclosure aims of the Nuremberg Code, as well as an extensive body of meta-research evidence. Those sources jointly support a range of new disclosures in the informed consent process that would unmask the heretofore undisclosed information. The resulting proposed new disclosures pertain to the overall success prospects of clinical trials, the quality of the prior research that both forms the basis of clinical trials and informs assessment of their risks and benefits, the potential social value of clinical trials, and the commercial purposes of clinical trials. (shrink)

The revised Common Rule includes a new option for the conduct of secondary research with identifiable data and biospecimens: regulatory broad consent. Motivated by concerns regarding autonomy and trust in the research enterprise, regulators had initially proposed broad consent in a manner that would have rendered it the exclusive approach to secondary research with all biospecimens, regardless of identifiability. Based on public comments from both researchers and patients concerned that this approach would hinder important medical advances, however, (...) regulators decided to largely preserve the status quo approach to secondary research with biospecimens and data. The Final Rule therefore allows such research to proceed without specific informed consent in a number of circumstances, but it also offers regulatory broad consent as a new, optional pathway for secondary research with identifiable data and biospecimens. In this article, we describe the parameters of regulatory broad consent under the new rule, explain why researchers and research institutions are unlikely to utilize it, outline recommendations for regulatory broad consent issued by the Secretary's Advisory Committee on Human Research Protections, and sketch an empirical research agenda for the sorts of questions about regulatory broad consent that remain to be answered as the research community embarks on Final Rule implementation. (shrink)

The long-standing overarching policy governing research with human subjects conducted and supported by most federal agencies and departments in the United States, known as the Common Rule, has recently been revised, with most requirements slated to become effective in 2018. Although there are multiple alterations to the current regulations, some of the most significant changes aim to enhance consent for research. While some of the particular provisions in this regard will be easy to apply and promise to help (...) meet this goal, others may be more challenging to implement despite their intuitive appeal. In this article, I examine some of the provisions in the revised Common Rule that relate to consent: new required consent elements; the goal of comprehension in the consent process; consent forms; and broad consent. By raising issues about these provisions now and suggesting possible ways to overcome their potential shortfalls, the hope is that future efforts can be taken to help clarify and appropriately implement them. (shrink)

Bajo el rótulo de "contractualismo" se agrupan diversas teorías que sostienen que la obligatoriedad de las normas descansa en el consentimiento de quienes están vinculados por ellas. No obstante, esta caracterización general obvia diferencias cruciales entre las distintas teorías contractualistas. Se analizan diversas tipologías para iluminar dichas diferencias y alcanzar una caracterización más exacta del contractualismo. Se concluye que la distinción entre consentimiento hipotético e ideal, al que recurren algunas versiones, torna imposible la formulación de una definición unívoca de contractualismo. (...) "Contractualism" refers to the diverse theories that maintain that the obligatory nature of norms rests on the consent of those bound by them. However, this general characterization overlooks crucial differences among the different contractualist theories. The article analyzes diverse typologies in order to highlight these differences and reach a more precise characterization of contractualism. It concludes that the distinction between hypothetical and ideal consent made by some of these versions makes it impossible to formulate a univocal definition of contractualism. Sob o título de "contratualismo", agrupam-se diversas teorias que sustentam que a obrigatoriedade das normas descansa no consentimento dos que estão vinculados por elas. Contudo, essa caracterização geral torna óbvias diferenças cruciais entre as diferentes teorias contratualistas. Analisam-se diversas tipologias para iluminar essas diferenças e alcançar uma caracterização mais exata do contratualismo. Conclui-se que a diferença entre consentimento hipotético e ideal, à qual recorrem algumas versões, torna impossível a formulação de uma definição unívoca de contratualismo. (shrink)

Improving the informed consent process is a common theme in literature regarding biomedical human subjects research. Standards for appropriate language and required information have undergone scrutiny and evolved over time. One response to the call for improvement is the provision and use of informed consent templates to ensure that documents have a standardized format and quality of content. Little is known, however, about the prevalence of such ICTs or their effectiveness. This article discusses the rationale for creating (...) and using templates, describes the prevalence of and commonalities between templates, and identifies the need for an evaluation of their effectiveness in terms of their ethical and practical implications. The websites of 144 Association of American Medical Colleges -accredited institutions in the United States, 21 institutes in the National Institutes of Health, and the World Health Organization were searched for the presence of ICTs. A total of 105 medical schools, 3 NIH institutes, and the WHO had at least one ICT publicly available on their websites. The templates varied in format, length, style, language, and sections included. The prevalence of ICTs, variability in their content, and lack of published research regarding their effectiveness suggest that ICTs are available, but more research into their effectiveness and standardization of their development are needed. (shrink)

Informed consent in clinical research is widely regarded as broken, but essential nonetheless. The most recent attempt to reform it comes as part of the first revisions to the Common Rule since it became truly “common” in 1991. This change, the addition of a “key information” requirement for most consent forms, is intended to support and promote a reasoned decision-making process by potential subjects. The key information requirement is both promising and problematic. It is promising because (...) it encourages clarity and honesty about research participation, creativity in information disclosure, and mutual learning through the investigator-subject relationship. It is problematic because those goals — which have remained aspirational since the beginning — may be difficult to achieve in what has become an excessively compliance-oriented regulatory regime. (shrink)

People in extraordinary situations are vulnerable. As research participants, they are additionally threatened by abuse or exploitation and the possibility of harm through research. To protect people against these threats, informed consent as an instrument of self-determination has been introduced. Self-determination requires autonomous persons, who voluntarily make decisions based on their values and morals. However, in nursing research, this requirement cannot always be met. Advanced age, chronic illness, co-morbidity and frailty are reasons for dependencies. These in turn lead to (...) limited abilities or opportunities for decision-making and self-determination. Exclusion of vulnerable people from research projects would disadvantage them by not covering their needs, which would violate the ethical principles of justice and beneficence. Commonly, vulnerability is attributed to social groups. The consequence for individuals, attributed as belonging to such a vulnerable group, is that the principles of respect for autonomy, justice and beneficence are subordinated to the principle of non-maleficence, understood as avoiding the risk to cause more harm than good. In addition, group-specific attribution could lead to stigmatizing because labelling a person as deviation from a norm violates integrity. For clinical nursing research, the question arises how the protection of vulnerable people could be granted without compromising ethical principles. The concept of relational ethics provides a possible approach. It defines vulnerability as the relation between a person’s health status and the extent to which this person is dependent on the researcher and the research context. Vulnerability is not attributed solely to a person but to a situation, meaning the person is viewed in context. By combining vulnerability as a context-related and situational concept with existing approaches of informed consent, the different ethical principles can be balanced and preserved at every step of the research process. (shrink)

Our decision-making is often subject to framing effects: alternative but equally informative descriptions of the same options elicit different choices. When a decision-maker is vulnerable to framing, she may consent under one description of the act, which suggests that she has waived her right, yet be disposed to dissent under an equally informative description of the act, which suggests that she has not waived her right. I argue that in such a case the decision-maker’s consent is simply irrelevant (...) to the permissibility of proceeding. I then consider two alternative views. According to the first, people susceptible to framing are able to give valid consent so long as they are sufficiently informed. This suggestion, I argue, maintains an overly narrow focus on mere quantity of information to the exclusion of other choice-affecting factors. A second response, which appeals to hypothetical consent, is likewise of little use in resolving the moral problem posed by framing effects. I conclude that if susceptibility to framing undermines the validity of consent, we may have good reason to reconsider whether consent has the rights-waiving function commonly attributed to it. (shrink)

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons (...) for consent, the range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and tim.. (shrink)

In the United States, final amendments to the Federal Policy for the Protection of Human Subjects (“the Common Rule”) were published on January 19, 2017, and they will take effect on January 21, 2019. One of the most widely discussed provisions is that for the first time, federal regulations governing research with humans authorize the use of broad consent for future, unspecified research on individually identifiable biospecimens and associated data. Many questions have been raised about broad consent, (...) including what effect it will have on research and whether it adequately protects the interests of research participants.There are lessons to be learned for the U.S. and other countries by looking to countries that already have experience with broad consent for biobank collection and with the storage and subsequent use of the biospecimens and data. This article describes how broad consent works in five countries—Canada (in Quebec), Israel, Nigeria, Taiwan, and the United Kingdom—and with different types of biobanks: national biobanks, federated biobanks, and regional biobanks. Evaluating the provisions and challenges of the broad consent approaches in these countries can inform policies for this increasingly used approach to biobank regulation. (shrink)

Abstract:Vulnerability is an important criterion to assess the ethical justification of the inclusion of participants in research trials. Currently, vulnerability is often understood as an attribute inherent to a participant by nature of a diagnosed condition. Accordingly, a common ethical concern relates to the participant’s decisionmaking capacity and ability to provide free and informed consent. We propose an expanded view of vulnerability that moves beyond a focus on consent and the intrinsic attributes of participants. We offer specific (...) suggestions for how relational aspects and the dynamic features of vulnerability could be more fully captured in current discussions and research practices. (shrink)

Informed consent is one of the foundational ethical and legal requirements of research with human subjects. The Nuremberg Code, the Helsinki Declaration, the Belmont Report, the Common Rule and many other laws and codes require that research subjects make a voluntary, informed choice to participate in research.12345 Informed consent is based on the moral principle of respect for autonomy, which holds that rational individuals have a right to make decisions and take actions that reflect their values and (...) preferences. 6 Whereas most guidelines and codes also require that informed consent be properly documented, informed consent is much more than signing a piece of paper: It is a continuous process of communication between the investigator and the research subject. 7 Because the body of knowledge impacting a study frequently changes, subjects should receive information from investigators after they have enrolled in a study, such as significant new findings that may affect their decision to participate in research or clinically useful tests results. 8910 In large studies, some investigators use newsletters to update subjects on the progress of research and other developments.11Most of the ongoing communications between investigators and subjects involve little more than information sharing, without revisiting the decision to participate in research or signing any additional documents. Sometimes, however, it may be necessary for subjects to reaffirm their decision to participate, to re-consent, or to sign or re-sign a document. 8 Re-consent can be defined as an action in which a subject makes the decision to participate in research once again. Re-consent is different from reaffirming a commitment to participate in a study, because in re-consent one actually reconsiders the information necessary to make decision, whereas in reaffirmation one simply expresses …. (shrink)

The two most commonly discussed and implemented rationales for acquiring organs for transplantation give consent a central role. I argue that such centrality is a mistake. The reason is that practices of consent serve only to respect patients as autonomous beings. The primary issue in acquiring organs for transplantation, however, is how it is appropriate to treat a newly non-autonomous being. Once autonomy and consent are dislodged from their central position, considerations of utility and fairness take a (...) more prominent position. On the basis of these values, a strongly suggestive moral case is presented for routinely harvesting organs for transplantation. (shrink)

Abstract:Vulnerability is an important criterion to assess the ethical justification of the inclusion of participants in research trials. Currently, vulnerability is often understood as an attribute inherent to a participant by nature of a diagnosed condition. Accordingly, a common ethical concern relates to the participant’s decisionmaking capacity and ability to provide free and informed consent. We propose an expanded view of vulnerability that moves beyond a focus on consent and the intrinsic attributes of participants. We offer specific (...) suggestions for how relational aspects and the dynamic features of vulnerability could be more fully captured in current discussions and research practices. (shrink)

Until 2008, if doctors followed the General Medical Council's (GMC's) guidance on providing information prior to obtaining a patient's consent to treatment, they would be going beyond what was technically required by the law. It was hoped that the common law would catch up with this guidance and encourage respect for patients' autonomy by facilitating informed decision-making. Regrettably, this has not occurred. For once, the law's inability to keep up with changing medical practice and standards is not the (...) problem. The authors argue that while the common law has moved forward and started to recognise the importance of patient autonomy and informed decision-making, the GMC has taken a step back in their 2008 guidance on consent. Indeed, doctors are now required to tell their patients less than they were in 1998 when the last guidance was produced. This is an unfortunate development and the authors urge the GMC to revisit their guidance. (shrink)

Informed consent has become the most obvious instantiation of patient autonomy in contemporary medicine, though as a practice it does not encompass all spheres of medicine. While diagnostic radiological procedures carry some risk due to the use of radiation, there is no standardized practice of informed consent in the United States. The authors describe the ethical justification of informed consent, the legal background surrounding it, and a brief history of radiology and radiological protection. They ultimately argue that (...) informed consent should become a common practice in computed tomography given the risks involved due to radiation exposure, especially considering the overuse of this technology, since it respects patient autonomy. (shrink)

It is commonly claimed that when X coerces Y into consenting to Z φ-ing, Y’s consent is invalid, and Z is only permitted to φ if this reduces harm or increases optionality for Y. This article demonstrates that Y’s consent in such cases is valid if Y is choosing between options that include all those Z has a duty to offer Y and no autonomy-reducing options Z has a duty to not offer Y. When these conditions are met, (...) Z acts permissibly in φ-ing even if φ-ing does not reduce harm for Y or increase Y’s optionality. (shrink)

Obtaining informed consent from patients prior to a medical or surgical procedure is a fundamental part of safe and ethical clinical practice. Currently, it is routine for a significant part of the consent process to be delegated to members of the clinical team not performing the procedure (eg, junior doctors). However, it is common for consent-taking delegates to lack sufficient time and clinical knowledge to adequately promote patient autonomy and informed decision-making. Such problems might be addressed (...) in a number of ways. One possible solution to this clinical dilemma is through the use of conversational artificial intelligence using large language models (LLMs). There is considerable interest in the potential benefits of such models in medicine. For delegated procedural consent, LLM could improve patients’ access to the relevant procedural information and therefore enhance informed decision-making.In this paper, we first outline a hypothetical example of delegation of consent to LLMs prior to surgery. We then discuss existing clinical guidelines for consent delegation and some of the ways in which current practice may fail to meet the ethical purposes of informed consent. We outline and discuss the ethical implications of delegating consent to LLMs in medicine concluding that at least in certain clinical situations, the benefits of LLMs potentially far outweigh those of current practices. (shrink)

Researchers increasingly rely on large data sets of health information, often linked with biological specimens. In recent years, the argument has been made that obtaining informed consent for conducting records-based research is unduly burdensome and results in ?consent bias.? As a type of selection bias, consent bias is said to exist when the group giving researchers access to their data differs from the group denying access. Therefore, to promote socially beneficial research, it is argued that consent (...) should be unnecessary. After analyzing the biostatistics evidence and bioethics arguments, the article concludes that (1) claims about the amount of consent bias are overstated; (2) commonly used statistical methods usually can account for consent bias; and (3) any residual effects of consent bias are below an acceptable level of imprecision and constitute a reasonable social cost for conducting ethically responsible research. (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)

Broad genome-wide testing is increasingly finding its way to the public through the online direct-to-consumer marketing of so-called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision-making with regard to the testing offer, we argue that (...) current practices of information provision are insufficient and that there is a place – and a need – for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings. (shrink)

A commonly accepted criticism of the social contract approach to justifying political authority targets the notion of hypothetical consent. Hypothetical contracts, it is argued, are not binding; therefore hypothetical consent cannot justify political authority. I argue that although hypothetical consent may not be capable of creating political obligation, it has the power to legitimate political arrangements.

BackgroundIn clinical research, obtaining informed consent from participants is an ethical and legal requirement. Conveying the information concerning the study can be done using multiple methods yet this step commonly relies exclusively on the informed consent form alone. While this is legal, it does not ensure the participant’s true comprehension. New effective methods of conveying consent information should be tested. In this study we compared the effect of different methods on the knowledge of caregivers of participants of (...) a clinical trial on Pemba Island, Tanzania.MethodsA total of 254 caregivers were assigned to receive a pamphlet, an oral information session or a pamphlet and an oral information session about the clinical trial procedures, their rights, benefits and potential risks. Their post-intervention knowledge was assessed using a questionnaire. One group of caregivers had not received any information when they were interviewed.ResultsIn contrast to the pamphlet, attending an information session significantly increased caregivers’ knowledge for some of the questions. Most of these questions were either related to the parasite or to the trial design.ConclusionsIn conclusion, within our trial on Pemba Island, a pamphlet was found to not be a good form of conveying clinical trial information while an oral information session improved knowledge. Not all caregivers attending an information session responded correctly to all questions; therefore, better forms of communicating information need to be found to achieve a truly informed consent. (shrink)

The dominant legal and regulatory approach to protecting information privacy is a form of mandated disclosure commonly known as “notice-and-consent.” Many have criticized this approach, arguing that privacy decisions are too complicated, and privacy disclosures too convoluted, for individuals to make meaningful consent decisions about privacy choices—decisions that often require us to waive important rights. While I agree with these criticisms, I argue that they only meaningfully call into question the “consent” part of notice-and-consent, and that (...) they say little about the value of notice. We ought to decouple notice from consent, and imagine notice serving other normative ends besides readying people to make informed consent decisions. (shrink)

Unrealistic therapeutic beliefs are very common—the majority of patient-subjects enrol in phase 1 trials seeking and expecting significant medical benefit, even though the likelihood of such benefit has historically proven very low. The high prevalence of therapeutic misestimation and unrealistic optimism in particular has stimulated debate about whether unrealistic therapeutic beliefs in early-phase clinical trials preclude adequate informed consent. We seek here to help resolve this controversy by showing that a crucial determination of when such therapeutic beliefs are (...) ethically problematic turns on whether they are causally linked and instrumental to the motivation to participate in the trial. Thus, in practice, it is ethically incumbent on researchers to determine which understanding and beliefs lead to the participant’s primary motivation for enrolling, not to simply assess understanding, beliefs and motivations independently. We further contend that assessing patient-subjects’ appreciation as a component of informed consent—it is already an established component of decision-making capacity assessments—can help elucidate the link between understanding-beliefs and motivation; appreciation refers to an individual’s understanding of the personal significance of both the medical facts and the experience of trial participation. Therefore, we recommend that: in addition to the usual question, ‘Why do you want to participate in this trial?’, all potential participants should be asked the question: ‘What are you giving up by participating in this trial?’ and researchers should consider the settings in which it may be possible and practical to obtain ‘two-point consent’. (shrink)

Gametes, tissue, and organs can be taken from the dying or dead for reproduction, transplantation, and research. Whole bodies as well as parts can be used for teaching anatomy. While these uses are diverse, they have an ethical consideration in common: the claims of the people whose bodies are used. Is some use permissible only when people have consented to the use, actually wanted the use, would have wanted the use, not opposed the use, or what? The aim of (...) this article is to make progress in answering these questions. Initially I assume knowledge of people’s desires in order to test whether consent is directly required by their rights without worrying about mistaken uses against their wishes. I claim consent is not directly required by people’s rights. If we know people wanted or would want a use, their rights permit the use, but if we know they wanted or would want not to be used, their rights do not permit the use. The knowledge assumption is then dropped and the question becomes how to decide what to do when the wishes of rightholders are not known. I suggest working out what to do when wishes are known and then adjusting, on the basis of whatever evidence there is, for probability and strength of desire. There are other considerations too, for instance about default rules. The key general comment here is that, in setting rules, the costs to rightholders in not getting what they want needs to be taken into account. The final section tries to show that, in setting these rules, mistaken uses are not to be taken as worse than mistaken failure to use. (shrink)

A very common but untested assumption is that potential children would consent to be exposed to the harms of existence in order to experience its benefits. And so, would-be parents might appeal to the following view: Procreation is all-things-considered permissible, as it is morally acceptable for one to knowingly harm an unconsenting patient if one has good reasons for assuming her hypothetical consent—and procreators can indeed reasonably rely on some notion of hypothetical consent. I argue that (...) this view is in error. My argument appeals to a consent-based version of anti-natalism advanced by Seana Valentine Shiffrin. Anti-natalism is the view that it is always wrong to bring people into existence. While, like Shiffrin, I stop short of advocating a thoroughgoing anti-natalism, I nevertheless argue that procreators cannot appeal to hypothetical consent to justify exposing children to the harms of existence. I end by suggesting a more promising route by which this justification might be achieved. (shrink)

'Tacit consent' has long interested historians of political thought and political philosophers, but its nuances nevertheless remain unappreciated. It has its roots in the Roman law concept of a 'tacit declaration of will'. Explicating this concept allows a new conception of tacit consent to be proposed, which I term the 'tacit declaration of consent'. The tacit declaration of consent avoids both the triviality of common sense views and a weakness in Hobbes' account. Unlike other contemporary (...) philosophical accounts, it avoids fictions and meets the condition of intentionality. Furthermore, it also advances understanding of the sorts of claim offered by proponents of a tacit consent-based theory of political obligation, whilst facilitating a more radical critique. The tacit consent-based theory of political obligation is not simply limited in application, but indefensible. It unwarrantedly transposes onto tacit consent the potentially fictional character of declarations of will. (shrink)

The U.S. Department of Health and Human Services has proposed substantial changes to the current regulatory system governing human subjects research in its Advanced Notice of Proposed Rulemaking, entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” Some of the most significant proposed changes concern the use of biospecimens in research. Because research involving biological materials begins with an initial interaction with an individual, such research falls squarely within the human subjects (...) research regulatory framework known as the “Common Rule,” which applies to research conducted or funded by the HHS and the other signatory agencies and departments. However, as described in detail below, much biospecimen research may fall within exemptions and exceptions under the Common Rule and, thus, may be conducted without consent. The ANPRM proposes requiring written consent for research use of biospecimens, even if the biospecimens were initially collected for a purpose other than research or have been stripped of identifiers. (shrink)

This paper evaluates four recent randomized clinical trials in which the informed consent of participants was either not sought at all, or else was conducted with critical information missing from the consent documents. As these studies have been taking place, various proposals to conduct randomized clinical trials without consent have been appearing in the medical literature. Some of the explanations offered for why it is appropriate to bypass consent or disclosure requirements appear to represent a fundamental (...) misunderstanding of applicable government regulations and even the research enterprise. Others are the result of conceptual disagreements about the importance and application of traditional research ethics norms to ‘comparative effectiveness research’ and modern research environments. Common among these explanations, however, is a failure to appreciate when a research intervention, rather than merely an observation or review of data, is taking place. Review committees and investigators are failing to see, or choosing to ignore, interventions in the lives of research subjects. When these studies have come to light, government agencies with oversight authority have done little or backed down. Prestigious medical journals have published research results knowing that the required consent was not obtained, or they have stood by the published studies even after the inadequacy of consent is discovered. This article critically examines this erosion of consent in theory and practice and calls for restoring the requirement of informed consent to its proper place as a priority in human subjects research. (shrink)

An episiotomy is ‘an intrapartum procedure that involves an incision to enlarge the vaginal orifice,’1 and is primarily justified as a way to prevent higher degrees of perineal trauma or to facilitate a faster birth in cases of suspected fetal distress. Yet the effectiveness of episiotomies is controversial, and many professional bodies recommend against the routine use of episiotomies. In any case, unconsented episiotomies are alarmingly common, and some care providers in obstetric settings often fail to see consent (...) as necessary in context. In their article, ‘The ethics of consent during labour and birth: episiotomies,’ van der Pijl et al reiterate that consent is necessary for episiotomies. They specify, further, that the antenatal period is crucial for exchanging information, establishing trust between the birthing subject and provider, and exploring the birthing subject’s—rather than the care provider’s—values and preferences regarding episiotomies. They recommend an individualised approach, which would enable birthing subjects to choose how and when they want to give consent. I applaud van der Pijl et al on their practicable recommendations regarding consent for episiotomies. This is certainly a step in the right direction where respect for birthing subjects’ bodily autonomy and integrity is concerned. Still, we must be reminded that consent alone is not coextensive with autonomy. The conditions for securing informed consent in healthcare does not guarantee that one’s decision is truly reflective of their values. After all, even valid consent does not rule out ‘normatively significant external influence’.2 Consent acquisition for obstetric procedures present no …. (shrink)

Substantial efforts have recently been made to reform the physician-patient relationship, particularly toward replacing the `silent world of doctor and patient' with informed patient participation in medical decision-making. This 'new ethos of patient autonomy' has especially insisted on the routine provision of informed consent for all medical interventions. Stronly supported by most bioethicists and the law, as well as more popular writings and expectations, it still seems clear that informed consent has, at best, been received in a lukewarm (...) fashion by most clinicians, many simply rejecting what they commonly refer to as the `myth of informed consent'. The purpose of this book is to defuse this seemingly intractable controversy by offering an efficient and effective operational model of informed consent. This goal is pursued first by reviewing and evaluating, in detail, the agendas, arguments, and supporting materials of its proponents and detractors. A comprehensive review of empirical studies of informed consent is provided, as well as a detailed reflection on the common clinician experience with attempts at informed consent and the exercise of autonomy by patients. In the end, informed consent is recast as a management tool for pursuing clinically and ethically important goods and values that any clinician should see as meriting pursuit. Concurrently, the model incorporates a flexible, anticipatory approach that recognizes that no static, generic ritual can legitimately pursue the quite variable goods and values that may be at stake with different patients in different situations. Finally, efficiency of provision is addressed by not pursuing the unattainable and ancillary. Throughout, the traditional principle of beneficence is appealed to toward articulating an operational model of informed consent as an intervention that is likely to change outcomes at the bedside for the better. (shrink)

Recent years have seen a proliferation of philosophical work on consent. Within this body of work, philosophers often appeal to an account of the interests, values, or functions that underpin the power of consent. By far the most commonly cited value realized by the power of consent is the promotion and protection of the power-holder’s autonomy. This focus on autonomy yields what I call the Gate Opener Model of consent, according to which the central valuable function (...) of consent is to give the power-holder control over whether other people can act in certain ways. In this article, I argue that the Gate Opener Model of consent is inadequate. I then defend an alternative Relational Model of consent, according to which a central valuable function of consent is to enable a non-instrumentally valuable form of interaction between people. (shrink)