This narrative review summarizes the empirical literature on children's competence for consent and assent in research and treatment settings. Studies varied widely regarding methodology, particularly in the areas of participant sampling, situational context studied (e.g., psychological versus medical settings), procedures used (e.g., lab-based vs. real-world approaches), and measurement of competence. This review also identified several fundamental dilemmas underlying approaches to children's informed consent. These dilemmas, including autonomy versus best interests approaches, legal versus psychological or ethical approaches, child- versus family-based approaches, (...) and approaches that emphasize consent versus those that emphasize assent, have implications for the measurement of children's competence and interpretation of findings. Recommendations for future research in the area of children's informed consent include the use of diverse samples and control groups, development of multidimensional and standardized measures of competence, utilization of observational methods and longitudinal designs, examination of noncognitive aspects of children's competence, and comparison of children's competence for treatment and research decisions. (shrink)

Background There is longstanding consensus on the need to include pregnant women in research. The goal of clinical research is to find highly regulated, carefully controlled, morally responsible ways to generate evidence about how to effectively and safely prevent illness or treat sick people. This manuscripts present a conceptual analysis of the ethicality of clinical trials in 3 scenarios: where the pregnant is involved in clinical trials as a participant during pregnancy for data that addresses pregnancy complications, where the pregnant (...) woman consents to clinical trial participation for an unborn baby that has complications, to generate data on complications at this stage of life, and where the mother may consent for participation of their newborn child in clinical trials. Methods Conceptual analysis. Findings Investigators often choose to exclude pregnant women and newborns from research, even where there is possibility for them to benefit from the study intervention. Objections include vulnerability of pregnant women, altered pharmacokinetics and risk of adverse effects, with a need to balance potential maternal and fetal risks and benefits of research participation. While the objections may be valid, not performing research magnifies what should be a carefully controlled risk during research, pushing this risk into the clinical setting, and subsequently posing a challenge to clinicians who are faced with making treatment decisions for pregnant patients with limited evidence of efficacy and safety. The potential benefits of fair inclusion in clinical trials outweigh the potential risks. Conclusion Research involving pregnant women is necessary to provide women with effective treatment during pregnancy, to promote fetal safety, and to reduce avoidable harm from suboptimal care and to provide pregnant women, their fetuses and newborns. (shrink)

This paper provides an introduction to ethical issues arising in children's research that takes place in school-settings. It addresses three main areas of ethical concern: the informed consent process, confidentiality, and harm and benefit. Informed consent in school settings is characterized by the involvement of multiple stakeholders, including not just researchers, parents and individual children but also school principals, teachers and the children's peer group. The added complexity of the setting has implications for the management of the informed consent process, (...) including the decision at what point and in which manner each stakeholder group needs to be involved in the process. The presence and divergent roles of these multiple stakeholders in the school setting also have implications for addressing issues of confidentiality, especially due to the group setting in which participants take part in the research and role expectations within school settings. Harm and benefit in school-based research are of a non-physical nature; relevant areas of concern relate primarily to the potential for psychological and social harm, realistic presentation of likely benefits from research and the issue of rewards for research participation. (shrink)

Background There is longstanding consensus on the need to include pregnant women in research. The goal of clinical research is to find highly regulated, carefully controlled, morally responsible ways to generate evidence about how to effectively and safely prevent illness or treat sick people. This manuscripts present a conceptual analysis of the ethicality of clinical trials in 3 scenarios: where the pregnant is involved in clinical trials as a participant during pregnancy for data that addresses pregnancy complications, where the pregnant (...) woman consents to clinical trial participation for an unborn baby that has complications, to generate data on complications at this stage of life, and where the mother may consent for participation of their newborn child in clinical trials. Methods Conceptual analysis. Findings Investigators often choose to exclude pregnant women and newborns from research, even where there is possibility for them to benefit from the study intervention. Objections include vulnerability of pregnant women, altered pharmacokinetics and risk of adverse effects, with a need to balance potential maternal and fetal risks and benefits of research participation. While the objections may be valid, not performing research magnifies what should be a carefully controlled risk during research, pushing this risk into the clinical setting, and subsequently posing a challenge to clinicians who are faced with making treatment decisions for pregnant patients with limited evidence of efficacy and safety. The potential benefits of fair inclusion in clinical trials outweigh the potential risks. Conclusion Research involving pregnant women is necessary to provide women with effective treatment during pregnancy, to promote fetal safety, and to reduce avoidable harm from suboptimal care and to provide pregnant women, their fetuses and newborns. (shrink)

Among the "hard cases" of captive animal research is the continued use of chimpanzees in harmful experimental science. In a recent article I contend that contemporary animal welfare science and chimpanzee behavioral studies permit, if not require, a reappraisal of the moral significance of chimpanzee dissent from participation in certain experiments. In what follows, I outline my earlier argument, provide a brief survey of some central concepts in pediatric research ethics, and use these to enrich an understanding of chimpanzee dissent (...) useful for research ethics. (shrink)

BackgroundCurrent guidelines do not clearly outline when assent should be attained from paediatric research participants, nor do they detail the necessary elements of the assent process. This stems from the fact that the fundamental justification behind the concept of assent is misunderstood. In this paper, we critically assess three widespread ethical arguments used for assent: children’s rights, the best interests of the child, and respect for a child’s developing autonomy. We then outline a newly-developed two-fold justification for the assent process: (...) respect for the parent’s pedagogical role in teaching their child to become an autonomous being and respect for the child’s moral worth.DiscussionWe argue that the ethical grounding for the involvement of young children in medical decision-making does not stem from children’s rights, the principle of best interests, or respect for developing autonomy. An alternative strategy is to examine the original motivation to engage with the child. In paediatric settings there are two obligations on the researcher: an obligation to the parents who are responsible for determining when and under what circumstances the child develops his capacity for autonomy and reasoning, and an obligation to the child himself. There is an important distinction between respecting a decision and encouraging a decision. This paper illustrates that the process of assent is an important way in which respect for the child as an individual can be demonstrated, however, the value lies not in the child’s response but the fact that his views were solicited in the first place.SummaryThis paper demonstrates that the common justifications for the process of assent are incomplete. Assent should be understood as playing a pedagogical role for the child, helping to teach him how specific decisions are made and therefore helping him to become a better decision-maker. How the researcher engages with the child supports his obligation to the child’s parents, yet why the researcher engages with the child stems from the child’s moral worth. Treating a child as having moral worth need not mean doing what they say but it may mean listening, considering, engaging or involving them in the decision. (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)

Background In Canadian jurisdictions without specific legislation pertaining to research consent, the onus is placed on researchers to determine whether a child is capable of independently consenting to participate in a research study. Little, however, is known about how child health researchers are approaching consent and capacity assessment in practice. The aim of this study was to explore and describe researchers' current practices. Methods The study used a qualitative descriptive design consisting of 14 face-to-face interviews with child health researchers and (...) research assistants in Southern Ontario. Transcribed interviews were analysed for common themes. Results Procedures for assessing capacity varied considerably from the use of age cutoffs to in-depth engagement with each child. Three key issues emerged from the accounts: (1) requirements that consent be provided by a single person thwarted researchers' abilities to support family decision-making; (2) little practical distinction was made between assessing if a child was capable, versus determining if study information had been adequately explained by the researcher; and (3) participants' perceived that review boards' requirements may conflict with what they considered ethical consent practices. Conclusion The results suggest that researchers' consent and capacity knowledge and skills vary considerably. Perceived discrepancies between ethical practice and ethics boards' requirements suggest the need for dialogue, education and possibly ethics board reforms. Furthermore we propose, where appropriate, a ‘family decision-making’ model that allows parents and their children to consent together, thereby shifting the focus from separate assent and consent procedures to approaches that appropriately engage the child and family. (shrink)