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Switch to: References
Citations of:
Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children’s competence to consent to clinical research
Irma M. Hein, Martine C. De Vries, Pieter W. Troost, Gerben Meynen, Johannes B. Van Goudoever & Ramón J. L. Lindauer
BMC Medical Ethics 16 (1):1-7 (2015)
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Key legislations in many countries emphasize the importance of involving children in decisions regarding their own health at a level commensurate with their age and capacities. Research is engaged in developing tools to assess capacity in children in order to facilitate their responsible involvement. These instruments, however, are usually based on the cognitive criteria for capacity assessment as defined by Appelbaum and Grisso and thus ill adapted to address the life-situation of children. The aim of this paper is to revisit (...) |
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This pilot randomized controlled trial explored the feasibility, acceptability, and potential utility of an intervention to improve the decisional capacity (DC) for research consent/assent among youth living with HIV (YLWH). We randomly assigned 30 YLWH aged 13–24 to a control (paper-based) or intervention (multimedia) consent/assent condition. Using a between- and within-subjects design, participants completed a demographic questionnaire and measures of DC, acceptability/feasibility, and voluntary self-consent perceptions after undergoing a hypothetical consent/assent process for a biomedical HIV study. Findings suggest participants found (...) |
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Adolescence, defined in the US as 11–21 years of age, is a critical period for prevention, as it marks the onset of risk behaviors. Minor (<18 years) self-consent and inclusion in biomedical resear... |
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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 (...) |
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BackgroundThe research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent may be used to assess the research subject’s comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby adhering to the beneficence and nonmaleficence (...) |
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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 (...) |
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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 (...) |
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Background Decision-making competence is a complex concept in the care for transgender and gender diverse adolescents, since this type of care concerns one’s developing gender identity and involves treatment options that often lack international consensus. Even despite competence assessments, moral challenges arise in the decision-making process. Here, traditional forms of clinical ethics support such as moral case deliberation might not fit as these do not provide thematic guidance. This study therefore aimed to develop a practice-oriented ethics support tool to assist (...) |
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BackgroundWhile fertility preservation is recommended practice for paediatric oncology patients, it is increasingly being considered for transgender children and young people in paediatric care. This raises ethical issues for clinicians, particularly around consent and shared decision-making in this new area of healthcare.MethodsA systematic review of normative literature was conducted across four databases in June 2020 to capture ethical considerations related to fertility counselling and preservation in paediatric transgender healthcare. The text of included publications was analysed inductively, guided by the Qualitative (...) |
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According to a standard account of patient decision-making capacity, patients can provide ethically valid consent or refusal only if they are able to understand and appreciate their medical c... |
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BackgroundThe EU’s 2006 Paediatric Regulation aims to support authorisation of medicine for children, thus effectively increasing paediatric research. It is ethically imperative to simultaneously establish procedures that protect children’s rights.MethodThis study endeavours (a) to evaluate whether a template consent form designed by the Standing Working Group of the German-Research-Ethics-Committees (AKEK) adequately informs adolescents about research participation, and (b) to investigate associated phenomena like therapeutic misconception and motives for research participation. In March 2016 a questionnaire study was conducted among 279 pupils (...) |
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Child assent is recommended in addition to parental consent when enrolling children in clinical research; however, appreciation and relevance ascribed to these concepts vary in different contexts, and information on attitudes towards storage of biological samples for future research is limited, especially in developing countries. We assessed caregivers’ understanding and appreciation of consent and assent procedures, and their attitudes towards use of stored blood samples for future research prior to enrolling a child in clinical research. A total of 17 in-depth (...) |
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International research guidance has shifted towards an increasingly proactive inclusion of children and adolescents in health research in recognition of the need for more evidence-based treatment. Strong calls have been made for the active involvement of children and adolescents in developing research proposals and policies, including in decision-making about research participation. Much evidence and debate on this topic has focused on high-income settings, while the greatest health burdens and research gaps occur in low-middle income countries, highlighting the need to take (...) |
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Children’s preferences about medical treatment—like the preferences of other patients—hold moral weight in decision-making that is independent of considerations of autonomy or best interests. In light of this understanding of the moral value of patient preferences, the American Academy of Pediatrics could strengthen the ethical foundation for its formal guidance on pediatric assent. |
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Application of either the harm principle or the best interest standard to medical decision making conflicts with some types of pediatric research that pose elevated risk without the reasonable prob... |
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Human immunodeficiency virus and other sexually transmitted infections significantly burden youth 13–24 years of age in the United States. Directly engaging youth in sexual health research is a public health priority and urgently needed to develop targeted, youth-friendly, and culturally relevant HIV/sti prevention interventions. Controversies arise, however, regarding informed assent and consent, parental permission or consent, and the definition of “child”/“minor” as it relates to medical, legal, and ethical issues. In this article, we describe challenges in the human subjects review (...) |
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There is currently no consensus from the relevant stakeholders regarding the operational and construct definitions of child assent for research. As such, the requirements for assent are often construed in different ways, institutionally disparate, and often conflated with those of parental consent. Development of a standardized operational definition of assent would thus be important to ensure that investigators, institutional review boards, and policy makers consider the assent process in the same way. To this end, we describe a Delphi study that (...) |
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