Since children are considered incapable ofgiving informed consent to participate inresearch, regulations require that bothparental permission and the assent of thepotential child subject be obtained. Assent andpermission are uniquely bound together, eachserving a different purpose. Parentalpermission protects the child from assumingunreasonable risks. Assent demonstrates respectfor the child and his developing autonomy. Inorder to give meaningful assent, the child mustunderstand that procedures will be performed,voluntarily choose to undergo the procedures,and communicate this choice. Understanding theelements of informed consent (...) has been theparadigm for assessing capacity to give assent.This method leaves the youngest, leastcognitively mature children vulnerable towaiver of assent and forced researchparticipation. Voluntariness can also becompromised by the influence of authorityfigures who can exert undue influence andcoerce children to participate in research. This paper discusses factors that may influencethe decision to give assent/permission,potential parent-child conflict in theassent/permission process and how it isresolved, and potential parental undueinfluence on research participation. Theseissues are illustrated with quotations drawnfrom a larger qualitative study of parentalpermission and child assent (data notpresented). We suggest a developmentalapproach, viewing assent as a continuum rangingfrom mere affirmation in the youngest childrento the equivalent of the informed consentprocess in the mature adolescent. (shrink)

Guidelines around the world require children to provide assent for their participation in most research studies. Yet, little further guidance is provided on how review committees should implement this requirement, including which children are capable of providing assent and when the requirement for assent may be waived on the grounds that the research offers participating children the potential for important clinical benefit. The present paper argues that the assent requirement is supported by the importance of allowing (...) children who are capable to make their own decisions. This suggests children are capable of assent when they become able to understand the research in question. While development varies across individual children, existing data suggest most children develop this ability by approximately age 14. Until instruments are developed to assess the assent capacity of individual children, this age should be used as the threshold for assent. In addition, the importance of protecting children from harm suggests that the sustained dissent of all children, including those who are unable to provide assent, should be respected. While the assent requirement may be waived when research participation offers the potential for important medical benefit that is unavailable outside the research context, analysis suggests that children’s sustained dissent should be respected in all cases. (shrink)

Smajdor’s Reification and Assent in Research Involving Those Who lack Capacity claims, among other things, that ‘adults who cannot give informed consent may nevertheless have the ability to assent and dissent, and that these capacities are morally important in the context of research’.1 More pointedly, she suggests we can rely upon Gillick competence, or that ‘it is worth thinking about why the same trajectory [as children] has not been evident in the context of [adults with impairments of capacity (...) to give informed consent (AWIC)]’.1 I argue that her likening assent in AWIC to assent in children is problematic for at least two related reasons. First, direct comparisons between AWIC and children run the risk of perpetuating or reinforcing infantilising stereotypes against people with disabilities. Second, I argue that people with disabilities are vulnerable in ways that most children are not, and thus, are dissimilar in a morally relevant manner. The infantilising of people with disabilities is quite widely documented and thought to be deeply problematic.2 Not only are people with disabilities often thought to be infantile in regard to particular …. (shrink)

In her article Reification and assent in research involving those who lack capacity, Anna Smajdor shows how excluding adults with impairments of capacity (AWICs) to protect them from the risks of medical research has the paradoxical effect of harming them by reifying them.1 While the medical risks of excluding vulnerable populations in general from medical research are well known, the main risk being the creation of therapeutic orphans, the risk of reifying these populations is less discussed. Hence, we commend (...) Smajdor for introducing an essential nuance in the debate on inclusion of AWICs in medical research. We also agree with her on the importance of acquiring assent from those who cannot legally consent rather than automatically excluding them from research, as we already do in paediatric research. However, we believe that she fails to acknowledge some practical challenges already observed in paediatric research that hinder the retrieval of assent from AWICs and, consequently, their inclusion in medical research. In this commentary, we will first introduce the main challenge to using assent to include AWICs in research, that is, the fact that individuals might oscillate within the capacity spectrum. We will then provide other examples of practical obstacles to the inclusion of AWICs …. (shrink)

Anna Smajdor offers a fresh perspective on why assent is morally required in research practices involving people who (are considered to) lack the capacity to consent.1 Smajdor holds that seeking (and documenting) assent can be a mechanism to recognise those who (are considered to) lack the capacity to consent as participants ‘in our moral sphere’.1 Smajdor suggests that this approach can function as a counter to the ‘reifying’ attitudes (often) taken towards people who (are judged to) lack the (...) capacity to consent.1 Smajdor’s approach also offers novel resources to overcome what Giles Birchley characterise as ‘the problems of the binary approach to incapacity’.2 Particularly in the context of dementia research, Smajdor’s proposal can be seen as a promising direction for going beyond the conventional (primarily) ‘protective’ approach taken by research ethics committees.3 The conventional approach asks researchers to obtain autonomous authorisation from research participants and (at times, implicitly) relies on the assumption that the ability to give consent is the only autonomy-related ability or, in other words, the assumption that the inability to give consent indicates vulnerability due to non-autonomy/non-agency. But this assumption, as Smajdor notes, seems problematic. The ability to assent (or dissent) is also an autonomy-related ability. Many …. (shrink)

An informed consent and voluntary assent in biomedical research with adolescents is contingent on a variety of factors, including adolescent and parent perceptions of research risk, benefit, and decision-making autonomy. Thirty-seven adolescents with asthma and their parents evaluated a high or low aversion form of a pediatric asthma research vignette and provided an enrollment decision; their perceptions of family influence over the participation decision; and evaluations of risk, aversion, benefit, and burden of study procedures. Adolescents and their parents agreed (...) on research participation decisions 74% of the time, yet both claimed ultimate responsibility for the participation decision. Both rated most study procedures as significantly more aversive than risky. Parents were more likely to rate aspects of the hypothetical study as beneficial and to provide higher risk ratings for procedures. Disagreements concerning research participation decisions and decision-making autonomy have implications for the exercise of voluntary assent in biomedical research. (shrink)

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

Stoics and Sceptics distinguish belief (doxa) from a representationally and functionally similar but sub-doxastic state: passive yielding to appearance. Belief requires active assent to appearances, that is, affirmation of the appearances as true. I trace the roots of this view to Plato's accounts of doxa in the Republic and Theaetetus. In the Republic, eikasia and pistis (imaging and conviction) are distinguished by their objects, appearances versus ordinary objects; in the Theaetetus, perception and doxa are distinguished by their objects, proper (...) perceptibles versus ‘commons’, including being. But underlying these ontological distinctions is a psychological one: the lower mental states are confined to their lower objects because they are passive; the higher mental states have access to higher objects because they result from questioning appearances and making active affirmations about how things are. This doctrine of doxa anticipates both the Hellenistic one and modern accounts of belief as ‘aiming at truth’; it also shows Plato's views of doxa to have more in their favour philosophically and to cohere better with one another than generally thought. (shrink)

Several recent epistemologists have used understanding-assent links in theories of a priori knowledge and justification, but Williamson influentially argued against the existence of such links. Here I (1) clarify the nature of understanding-assent links and their role in epistemology; (2) clarify and clearly formulate Williamson’s arguments against their existence; (3) argue that Williamson has failed to successfully establish his conclusion; and (4) rebut Williamson’s claim that accepting understanding-assent links amounts to a form of dogmatism.

Assent is an important ethical and legal requirement of paediatric research. Unfortunately, there are significant differences between the guidelines on the details of assent.

Re-assent of adolescent females enrolled in clinical research through the onset of puberty is necessary to respect their rights to access sexual and reproductive health information, their rights under HIPAA as well as assuring compliance with the Common Rule.

In order to involve children in the decision-making process about participation in medical research it is widely recommended that the child’s assent be sought in addition to parental consent. However, the concept of assent is fraught with difficulties, resulting in confusion among researchers and ethics committees alike.

This article criticises existing solutions to the 'puzzle of imaginative resistance', reconstrues it, and offers a solution of its own. About the Book : Imagination, Philosophy and the Arts is the first comprehensive collection of papers by philosophers examining the nature of imagination and its role in understanding and making art. Imagination is a central concept in aesthetics with close ties to issues in the philosophy of mind and the philosophy of language, yet it has not received the kind of (...) sustained, critical attention it deserves. This collection of seventeen brand new essays critically examines just how and in what form the notion of imagination illuminates fundamental problems in the philosophy of art. (shrink)

We share Roberts and Buckloh's (this issue) concern about issues of assent and permission in research with children and agree that our research cannot conclude legitimately that (a) researchers failed to obtain permission/assent, (b) children were put at risk, or (c) failure to report permission/assent procedures was, in any way, unethical. We never made these conclusions. Rather, we argue that publishing assent and permission would enhance compliance with ethical standards, sensitize researchers and readers to its importance, (...) and shift publishing priorities in an appropriate direction. (shrink)

In accordance with ethical principles and standards, researchers conducting studies with children are expected to seek assent and respect their dissent from participation. Little attention has been given to assent and dissent in research with toddlers, who have limited cognitive and emotional capabilities. We discuss research with toddlers in the context of assent and dissent and propose guidelines to ensure that research with toddlers still adheres to ethical principles. These guidelines include designing engaging studies, monitoring refusal and (...) distress, and partnering with parents. Research with toddlers requires flexibility and creativity to respect toddlers in the context of their developmental capabilities. (shrink)

More than 20 years ago, the pioneering pediatric ethicist William Bartholome wrote a fiery letter to the editor of this journal because he thought a recently published statement on pediatric assent, from the Committee on Bioethics of the American Academy of Pediatrics (AAP), showed insufficient respect for children. That AAP statement, like its 2016 update, asserts that pediatric assent should be solicited only when a child’s dissent will be honored. Bartholome objected that pediatricians should always solicit children’s (...) class='Hi'>assent and that they should acknowledge and apologize when they treat children over their objections even when they must do so to promote children’s best interests. We think Bartholome was right. In this brief commentary, we elaborate on his perspective about the moral value of pediatric assent, and we suggest improvements to the corresponding clinical guidance. (shrink)

La crisi dello strutturalismo e i confini della semiotica in un volume importante della produzione di Eco. Un libro che trova la sua continuazione ideale in 'Lector in fabula'.

My paper on assent and reification in research involving adults with impairments of capacity and/or communication (AWIC)1 drew many thoughtful and insightful responses. I am grateful to all who submitted commentaries. Most agreed in principle that AWIC could be better represented in medical research. However, several commentators felt that further clarification was needed in terms of what assent is and how it should be obtained and operationalised.2 I fully agree that if increased representation of AWIC is to come (...) about through an assent-based approach, further clarificatory work is needed, and am glad to think my paper may function as a stimulus for this. Some commentators worry that an assent-based approach will impose heavy demands on researchers and entail higher costs.2 I acknowledge this, but would argue that if better inclusion of AWIC is a worthwhile goal, we should be willing to accept some costs. The move from an exclusionary to an inclusive approach will become less demanding once it is accepted as the default. And as I argue in my paper, we have resources on which to draw, including materials designed to facilitate comprehension and communication with AWIC that have been developed in other spheres,3 as well as existing protocols and structures that facilitate …. (shrink)

Pediatric biobanking is considered important for generating biomedical knowledge and improving health care. However, the inclusion of children’s samples in biobanks involves specific ethical issues. One of the main concerns is how to appropriately engage children in the consent procedure. We suggest that children should be involved through a personalized assent procedure, which means that both the content and the process of assent are adjusted to the individual child. In this paper we provide guidance on how to put (...) personalized assent into pediatric biobanking practice and consider both the content and process of personalized assent. In the discussion we argue that the assent procedure itself is formative. Investing in the procedure should be a requirement for pediatric biobank research. Although personalized assent will require certain efforts, the pediatric community must be aware of its importance. The investment and trust earned can result in ongoing engagement, important longitudinal information, and stability in/for the research infrastructure, as well as increased knowledge among its participants about research activity. Implementing personalized assent will both respect the child and support biobank research. (shrink)

Randomized Clinical Trials in the medical community are generally lasting longer due to a number of factors, including an increase in the total volume of biomedical research, expanded federal regulatory requirements, and a rise in patient interest in participating as research subjects. Leading national and international initiatives promote clinical research in children. The primary impetus for these initiatives is the need for adequate data for clinical application of new products and treatment approaches in the pediatric population. Clinical investigations must maintain (...) ethical conduct as an essential component of pediatric research.Ethical issues associated with clinical research in general have received prominent public and scientific attention. Of particular interest is informed consent, or assent, as applied to pediatrics. There is little practical guidance concerning pediatric assent from legal and ethical disciplines; the law has played only a small role in few cases. (shrink)

BackgroundFor many decades, the debate on children’s competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children’s competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally children of 11.2 (...) years and above were decision-making competent, while children of 9.6 years and younger were not. Age was pointed out to be the key determining factor in children’s competence. In this article we reflect on policy implications of these findings, considering legal, ethical, developmental and clinical perspectives.DiscussionAlthough assessment of children’s competence has a normative character, ethics, law and clinical practice can benefit from research data. The findings may help to do justice to the capacities children possess and challenges they may face when deciding about treatment and research options. We discuss advantages and drawbacks of standardized competence assessment in children on a case-by-case basis compared to application of a fixed age limit, and conclude that a selective implementation of case-by-case competence assessment in specific populations is preferable. We recommend the implementation of age limits based on empirical evidence. Furthermore, we elaborate on a suitable model for informed consent involving children and parents that would do justice to developmental aspects of children and the specific characteristics of the parent-child dyad.SummaryPrevious research outcomes showed that children’s medical decision-making capacities could be operationalized into a standardized assessment instrument. Recommendations for policies include a dual consent procedure, including both child as well as parents, for children from the age of 12 until they reach majority. For children between 10 and 12 years of age, and in case of children older than 12 years in special research populations of mentally compromised patients, we suggest a case-by-case assessment of children’s competence to consent. Since such a dual consent procedure is fundamentally different from a procedure of parental permission and child assent, and would imply a considerable shift regarding some current legislations, practical implications are elaborated. (shrink)

ALTHOUGH STOIC THOUGHT HAS SHAPED THE CHRISTIAN TRADITION IN decisive ways, Christian ethicists largely overlook the insights Stoicism offers for contemporary Christian discussion of virtue. This essay expands and elaborates our retrieval of ancient ethics of virtue by exploring Stoic "assent" and its possible intersections with Christian ethics. Rather than being tragically fatalistic, Stoic assent functions as a response to divine providence that is compatible with theological commitments that find particular expression in historical Protestant traditions: the claim that (...) salvation occurs by faith alone and a conviction that humans are both morally accountable and utterly dependent upon God. Stoic moral thought offers a framework for developing a morally rich account of the virtues that takes seriously these Christian beliefs. (shrink)

The enrolment of children and adolescents in health research requires that attention to be paid to specific assent and consent requirements such as the age range for seeking assent; conditions for parental consent (and waivers); the age group required to provide written assent; content of assent forms; if separate assent and parental consent forms should be used, consent from emancipated young adults; reconsent at the age of adulthood when a waiver of assent requirements may (...) be appropriate and the conditions for waiving assent requirements. There is however very little available information for researchers and ethics committees on how to navigate these different issues. To provide guidance to research initiatives, the SickleInAfrica consortium conducted a thematic analysis of a sample of research ethics guidelines and procedures in African countries, to identify guidance for assent requirements in health research. The thematic analysis revealed that 12 of 24 African countries specified the age group for which assent is required. The minimum age for written assent varied across the countries. Five countries, Algeria, Botswana, Cameroon, Nigeria and The Democratic Republic of Congo require consent from both parents/family council in certain circumstances. Botswana, Nigeria, South Africa and Uganda have specific assent/consent requirements for research with emancipated minors. South Africa and Algeria requires re-consent at onset of adulthood. Five countries (Botswana, Cameroon, Nigeria, South Africa and Tanzania) specified conditions for waiving assent requirements. The CIOMS and the ICH-GCP guidelines had the most comprehensive information on assent requirements compared to other international guidelines. An interactive map with assent requirements for different African countries is provided. The results show a major gap in national regulations for the inclusion of minors in health research. The SickleInAfrica experience in setting up a multi-country SCD registry in Africa highlights the need for developing and harmonising national and international guidelines on assent and consent requirements for research involving minors. Harmonisation of assent requirements will help facilitate collaborative research across countries. (shrink)

It is commonly held that there are internal links between understanding and assent such that being semantically competent with an expression requires accepting certain sentences as true. The paper discusses a recent challenge to this conception of semantic competence, posed by Timothy Williamson (2007). According to Williamson there are no understanding-assent links of the suggested sort, no internal connection between semantic competence and belief. I suggest that Williamson is quite right to question the claim that being semantically competent (...) with an expression e requires accepting a certain sentence S as true. However, Williamson does not merely wish to reject this version of the understanding-assent view, but the very idea that the connection with belief provides constitutive constraints on linguistic understanding and concept possession. This further move, I argue, is very problematic. Giving a plausible account of semantic competence requires accepting that there are constitutive links between understanding and assent, although these links should be construed holistically rather than atomistically. (shrink)

In applied ethics, and in medical treatment and research, the question of how we should treat others is a central problem. In this paper, I address the ethical role of assent in research involving human beings who lack capacity. I start by thinking about why consent is ethically important, and consider what happens when consent is not possible. Drawing on the work of the German philosopher Honneth, I discuss the concept of reification—a phenomenon that manifests itself when we fail (...) to observe or respond to our fellow humans’ need for recognition. I suggest that assent is a way of responding to this moral need for recognition, which exists independently of cognitive capacity. I will look at the circumstances in which consent cannot be obtained from human beings, and ask whether some of the same ethically important considerations that underpin the need for consent might be achieved through seeking assent. I discuss the ways in which this might be beneficial for researchers, for prospective research participants and for society at large. (shrink)

Kant identifies knowledge [Wissen], belief [Glaube], and opinion [Meinung] as our three primary modes of “holding-to-be-true” [Fürwahrhalten]. He also identifies opinion as making up the greatest part of our cognition. After a preliminary sketch of Kant’s system of propositional attitudes, this paper will explore what he says about the norms governing opinion and empirical hypotheses. The final section will turn to what, in the Critique of Pure Reason and elsewhere, Kant refers to as “General Applied Logic”. It concerns the “contingent (...) conditions of the subject, which can hinder or promote” good inquiry; and, though rarely mentioned in the secondary literature, it offers Kant’s methodological alternative to the traditional epistemological goal of finding “a sufficient and at the same time general criterion of truth”. (shrink)

How is it possible for David Hume to be both withering skeptic and constructive theorist? I recommend an answer like the Pyrrhonian answer to the question how it is possible to suspend all judgment yet engage in active daily life. Sextus Empiricus distinguishes two kinds of assent: one suspended across the board and one involved with daily living. The first is an act of will based on appreciation of reasons; the second is a causal effect of appearances. Hume makes (...) the same distinction, only he extends the sort of assent involved in daily life to theoretical matters as well. He is a skeptic both in finding no reason to grant the first sort of assent and in being subject to the second. (shrink)

Background Seeking assent from children for participation in medical research is an ethical imperative of numerous institutions globally. However, none of these organizations provide specific guidance on the criteria or process to be used when obtaining assent. The primary objective of this scoping review was to determine the descriptions of assent discussed in the literature and the reported criteria used for seeking assent for research participation in pre-adolescent children. Methods Medline and Embase databases were searched until (...) November 2020 using the term “assent” in the title or abstract. Inclusion criteria were (1) studies enrolling children which specifically described operationalization of the assent process and (2) studies of the assent process which provided a description of assent. Data collected included participant information, patient criteria for seeking assent, guidelines referenced, description of assent reported, how assent was obtained and assent information presented, and reported assent rate. For qualitative articles focusing on the assent process, important themes were identified. Results A total of 116 articles were included of which 79 (68.9%) operationalized assent and 57 studies (%) described the assent process. The most commonly reported criterion used to determine the ability of a child to assent was age (35.4%, 28/79). The reported minimal age for obtaining pediatric assent varied considerably across and within jurisdictions (5–13 years; median 7.5 years, IQR 7.0, 9.75). Cognitive ability was reported as a criterion for obtaining assent in 5.1% (4/79) of studies. Assent rates were only reported in 17.7% (14/79) of citations and ranged from 32.0 to 100%. Analysis of the 57 studies describing the assent process identified several themes, including age thresholds, assessment of capacity, variable knowledge of pediatric assent and parental roles. Conclusion We found significant variation in criteria used for assessment of patient capacity, delivery of information used to obtain assent and documentation of the assent process. While we acknowledge that individual children, settings and jurisdictions may require different approaches to obtaining assent, there should be agreement on important principles to be followed with resulting common guidance on assessing capacity, delivering information and documentation of the assent process for publication. (shrink)

I discuss Ruth Marcus' conception of beliefs as dispositional states related to possible states of affaires. While I agree with Marcus that this conception accounts for the necessary distinction between belief and linguistic assent, I argue that the relationship between dispositional beliefs and our assent attitudes is more complex, and should include other mental states, such as acceptances, which, although they contain voluntary elements, are further layers of dispositional doxastic attitudes.

These ten essays on Cicero's _Academic Books_ deal with various aspects of Academic scepticism, ancient epistemology, and the history of the Academy. The tradition from Socrates through to Galen is covered, with special emphasis on Carneades, Antiochus and, of course, Cicero himself.