Our objective is to understand how parents and children perceive their roles in decision making about research participation. Forty-five children (ages 4-15 years) with or without a chronic condition and 21 parents were the participants. A semistructured interview assessed perceptions of up to 4 hypothetical research scenarios with varying levels of risk, benefit, and complexity. Children were also administered the Peabody Picture Vocabulary Test, Third Edition, to assess verbal ability, as a proxy for the child's cognitive development. The audiotaped interviews (...) were transcribed and analyzed for themes related to parent and child decision-making roles. Both parents and children varied in their perceptions of decision-making roles. Child perceptions of parental influence on decision making as knowledge-based increased with cognitive development, whereas perceptions of parental influence as power-based decreased. Both children and parents commented that they would collaborate with each other when making decisions. Collaborative decision making appeared to increase with cognitive development. These findings suggest that approaches to child assent and parent permission should consider the parent-child relationship and how children and families typically make decisions. Future research is necessary to explain variation in the process of research decision making across children and families, explore the role of collaboration on children's decision-making skills, and understand developmental trajectories and mechanisms related to research decision making. (shrink)

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)

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)

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)

Background Research in children is essential for them to benefit from the outcomes of research but involvement must be weighed against potential harms. In many countries and circumstances, medical research legally requires parental consent until the age of 18 years, with poorly defined recommendations for assent prior to this. However, there is little research exploring how these decisions are made by families and the ethical implications of this. Aim To explore key ethical debates in decision-making for participation of children and (...) adolescents in a human papillomavirus (HPV) vaccine trial. Methods Semi-structured interviews were undertaken with Tanzanian girls (aged 9–16 years) who had participated in an HPV vaccine trial (n = 13), their parents or guardians (n = 12), and girls together with their parents (in paired parent-child interviews) (n = 6). The interviews were analysed using thematic analysis. Interview data came from a qualitative acceptability study undertaken as part of the Dose Reduction Immunobridging and Safety Study of Two Human Papillomavirus (HPV) Vaccines in Tanzanian Girls (DoRIS) trial. Results Girls and parents desired collaborative decision-making, with parents ultimately making the decision to consent. However, girls wanted a larger part in decision-making. Decisions to consent involved many people, including extended social networks, the trial team, media outlets and healthcare professionals and this resulted in conflicts to be negotiated. Deciding where to place trust was central in participants and parents considering decisions to consent and overcoming rumours about trial involvement. Conclusions Existing models of decision-making help to understand dynamics between parents, adolescents and researchers but neglect the important wider social impacts and the fundamental nature of trust. Children’s roles in discussions can be evaluated using the principles of consent: autonomy, freedom and information. Concepts such as relational autonomy help to explain mechanisms families use to negotiate complex consent decisions. Whilst interviewees supported the maintenance of legal parental consent, researchers must design consent processes centring the child to ensure that whole family decision-making processes are supported. (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)

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)