Child's assent in research : age threshold or personalisation?

BACKGROUND: Assent is an important ethical and legal requirement of paediatric research. Unfortunately, there are significant differences between the guidelines on the details of assent. DISCUSSION: What often remains unclear is the scope of the assent, the procedure for acquiring it, and the way in which children’s capacity to assent is determined. There is a general growing tendency that suggests that the process of assent should be personalised, that is, tailored to a particular child. This article supports the idea of personalisation. However, we also propose placing limits on personalisation by introducing a suggested requirement of assent starting at a school-age threshold. In some situations RECs/IRBs and researchers could reduce the suggested threshold. SUMMARY: A recommended age threshold is likely to serve the interests of children better than ambiguous and flexible criteria for personalised age determination

Pediatric assent for a study of antiretroviral therapy dosing for children in western Kenya: a case study in international research collaboration

Multinational collaborators in health research face particular ethical challenges when conducting studies involving vulnerable populations such as children. We use an example from our first attempt to implement pediatric assent in the context of a longstanding research and clinical partnership between Kenyan and American medical schools to highlight the ethical and procedural issues related to pediatric assent that must be considered for multinational, pediatric studies. We consider relevant domestic, professional, and international guidelines for assent in pediatric research subjects, and we discuss the particular ethical challenges related to pediatric assent in the Kenyan context. Finally, we propose a way forward for approaching pediatric assent within our collaborative research program in Kenya that may apply to other multinational research partnerships.Fogarty International Center at the National Institutes of Health [R25TW006070]; USAID-AMPATH Partnership, United States Agency for International Developmen

Berkeley on Assent and the 'Belief of Matter'

In PHK 73 Berkeley draws on the Lockean account of assent: our holding a proposition to be true is grounded in our “motives or reasons” for holding it to be true, and is proportioned to them. Berkeley applies this view of assent to our “belief of matter” (PHK 75; DHP II & III). Changing that belief - the main aim of PHK and DHP – supposes, first, that people become aware that their reasons for believing that a material substance exists are wrong, and secondly, that they have good reasons for believing that a spiritual substance exists. I wish to show that Berkeley makes use of a doctrine of assent at the meta-philosophical level, i. e. in order to account for our holding the immaterialist claim to be true. Philosophy itself is the object of assent. Does this entail that the status of immaterialism is similar to that of religion? Does Berkeley leave intact Locke's conception of the “grounds of probability”? Does he answer the old question whether assent is voluntary? Does he subscribe to Locke's claim that the object of assent is a proposition and to the related claim that having a proposition to which one may assent requires having the ideas of which the proposition is made up? My aim is to reconstruct the main lines of Berkeley's account of assent and to assess whether it is consistent with his philosophy of mind

Mutual Assent in the Corporate Contract: Forum Selection Bylaws

In recent years, frivolous and inefficient multijurisdictional stockholder litigation has become a costly burden on corporations in the United States. A popular solution among boards of directors has been to adopt bylaws with forum selection provisions (which require certain disputes to be litigated before one forum). Those who oppose this solution have challenged these provisions on the grounds that they were passed as bylaws—which are unilaterally adopted by boards without stockholder consent. These challengers argue that bylaws are like contracts, and, therefore, require the mutual assent of both stockholders and the corporation to be enforceable. This argument implicates a classic theory of corporate law—the contractarian theory—but vastly oversimplifies the relationship between a stockholder, her corporation and the board of directors. When the contractarian theory of corporate law is applied to the full legal and practical reality of that relationship, the mutual assent argument falls apart and the contractarian theory is shown to support the enforceability of bylaws

Brain lesion volume and capacity for consent in stroke trials: potential regulatory barriers to the use of surrogate markers

<p><b>Background and Purpose:</b> European directives and legislation in some countries forbid inclusion of subjects incapable of consent in research if recruitment of patients capable of consent will yield similar results. We compared brain lesion volumes in stroke patients deemed to have capacity to consent with those defined as incapacitated.</p> <p><b>Methods:</b> Data were obtained from 3 trials recruiting patients primarily with cortical stroke syndromes. Patients were recruited within 24 hours of onset and used MRI based selection or outcome criteria. Method of recruitment was recorded with stroke severity, age, and brain lesion volumes on Diffusion Weighted Imaging.</p> <p><b>Results:</b> Of the 56 subjects included, 38 (68%) were recruited by assent and 18 (32%) by consent. The assent group had a median lesion volume of 18.35 cubic centimetres (cc) (interquartile range [IQR] 8.27–110.31 cc), compared to 2.79 cc (IQR 1.31–12.33 cc) when patients consented (P=0.0004). Lesions were smaller than 5 cc in 7/38 (18%) in the assent group and 11/18 (61%) in the consent group (P=0.0024). There was good correlation between neurological deficit by NIH stroke scale score and lesion volume (r=0.584, P<0.0001). Logistic regression demonstrated NIHSS or lesion volume predicted capacity to consent.</p> <p><b>Conclusions:</b> Patients with acute stroke who retain capacity to consent have significantly smaller infarct volumes than those incapable of consent, and these are frequently below the limits where measurement error significantly compromises valid use of volumetric end points. Only a small proportion of patients with capacity to consent would be eligible for, and contribute usefully to, most acute stroke trial protocols.</p&gt

Assent Described: Exploring Perspectives From the Inside

Purpose- The purpose of this study was to describe the informed consent and assent experience for oncology research from the perspective of the participants: adolescents, their parents, and their physician providers. Design & Methods- This descriptive mixed-methods study included the pilot use of the Quality of Informed Consent Questionnaire (QuIC) with an adolescent population and semi-structured interviews with adolescents, their parents, and their physician providers within 48-72 hours of the informed consent and assent discussion for a pediatric oncology clinical trial and again 6-9 weeks later. Results: Adolescents and their parents scored considerably lower on part A of the QuIC than part B indicating a lower level of objective understanding of key elements of informed consent and assent. Qualitative interviews highlight participants\u27 self-reported poor memory or recollection of key details of the informed consent and assent discussion paralleling the QuIC findings for objective understanding. Conclusion- Findings from this pilot descriptive study suggest that adolescents and their parents feel more informed than they actually are. This dichotomy of experience seems to have been mitigated by a strong sense of trust in and connection with their physician provider. Practice Implications- Further exploration of adolescent and parent viewpoints regarding what they value as important in the content of the informed consent and assent and how that content is delivered is warranted. Additionally, understanding the origin of participants\u27 misunderstanding of the key elements of consent and assent may illuminate areas for future intervention-based research focused on improving the overall quality of informed consent and assent discussions