Empowering Voices: Implementing Ethical Practices for Young Children’s Assent in Digital Research

Amanda M. Mirabella, Ilene R. Berson, Michael J. Berson

Education Sciences, 3 May 2025

Open Access

Abstract

This article examines how young children express informed assent in research settings that incorporate digital tools, participatory methods, and play-based approaches. Drawing on data from three studies involving kindergarten and first-grade children (ages 5 to 7) in the southeastern United States, this cross-case analysis explores how children navigated their participation using multimodal and relational strategies. Conceptual play theory, social semiotics, and participatory research frameworks guided the analysis, emphasizing assent as an evolving, co-constructed process rather than a singular verbal agreement. Through video recordings, field notes, and action-oriented transcripts, we investigated how children expressed comfort, curiosity, and agency across diverse contexts—including virtual reality storytelling, video-cued reflection, and interactive eBooks. Findings illustrate that assent was negotiated through gesture, movement, silence, humor, and peer interaction, often extending beyond adult-defined research routines. Children reinterpreted their roles, shaped the pace of sessions, and co-constructed meaning through play and dialogue. This retrospective synthesis of three previously conducted studies offers practical and ethical insights for researchers working with young children, including the importance of ongoing assent checkpoints, developmentally appropriate explanations, and flexible research environments. We argue that ethical research with children must prioritize multimodal communication, child-led pacing, and relational trust to support authentic and meaningful participation. By reframing assent as a dynamic and multimodal process, this research contributes to emerging conversations about ethical responsiveness, agency, and inclusive practices in early childhood research.

Consensus on Adolescent and Young Adult HIV Research Consent in Low- and Middle-Income Countries

Consensus Statement

Suzanne Day,  Sonam J. Shah, Ujunwa F. Onyeama, Lauren Fidelak, Ucheoma Nwaozuru, Stuart Rennie, Abdulhammed Opeyemi Babatunde, Weiming Tang, Elzette Rousseau, Chisom Obiezu-Umeh, Kelechi Prince Chima, Nadia A. Sam-Agudu,  Erin C. Wilson, Seema K. Shah, Susan Nkengasong, Titilola Gbaja-Biamila, Bill G. Kapogiannis, Linda-Gail Bekker, Juliet Iwelunmor, Oliver Ezechi, Joseph D. Tucker

JAMA Network Open, 29 April 2025; 8(4)

Open Access

Key Points

Question 

What are practical strategies to improve informed consent processes for adolescents and young adults (AYAs; aged 10-24 years) in HIV research studies in low- and middle-income countries?

Findings 

This consensus statement addresses critical questions about empowering AYAs, involving parents in the research process, and developing policies to increase AYA inclusion in research based on data from a comprehensive scoping review, a crowdsourcing open call, and a diverse global group of people.

Meaning 

This consensus statement provides a framework to enhance inclusion of AYAs in HIV studies in low- and middle-income countries.

Abstract

Importance 

Many adolescents and young adults (AYAs) in low- and middle-income countries (LMICs) are excluded from HIV research because of challenges with informed consent for study participation, which makes it difficult to understand and improve the lives of AYAs living with HIV and AIDS in a wide variety of settings.

Objective 

To help increase the inclusion of AYAs in HIV research, we developed a consensus statement on practical strategies for improving AYA consent in HIV research in LMICs.

Evidence Review 

The VOICE (HIV Youth Informed Consent & Ethics in Research) Working Group included AYAs, researchers, community organizers, advocates, research ethics committee members, parents of AYAs, and bioethicists who drafted initial statement items using data from a global open call and scoping review. An adapted Delphi process was then used to develop consensus statement items. The process involved 3 rounds of online Likert-scale questionnaires and a hybrid (online and in-person) consensus summit in Lagos, Nigeria, in 2022, with the total study period lasting from August 23, 2021, to February 10, 2023.

Findings 

Thirty-five people participated in the final round of the Delphi process, including 14 individuals younger than 35 years (40.0%), 25 HIV researchers (71.4%), and 32 people who worked in an LMIC (91.4%). Twenty-five items reached a predefined threshold for consensus (≥80% agreement). Strong consensus emerged for formal mechanisms (eg, cocreation, crowdsourcing, or youth advisory boards) for AYA engagement in and education about research as well as for strategies to enhance parental and guardian involvement in HIV research when safe and appropriate. Capacity strengthening can allow AYAs to review research protocols, join ethical review committees, and advocate for regulatory change. Two items in the statement (alternatives to parental consent and raising awareness among research ethics committees about AYA-independent consent) required further refinement to reach the agreement threshold for inclusion.

Conclusions and Relevance 

Greater engagement of both AYAs and parents may help to enhance consent processes and increase the inclusion of AYAs in LMIC HIV research studies. The resulting consensus statement provides practical strategies for implementing improved consent processes for AYA research participation at the organizational, community, and policy levels, which may help foster greater inclusion of AYAs in HIV research and address existing data gaps.

Conclusions [taken from the full statement]

In this consensus statement study of strategies to improve AYA consent processes for HIV research in LMICs, we identified a set of 25 practical approaches by which consent processes might be improved. Improving consent processes is the first (albeit not the only) step toward improving inclusion of AYAs in HIV research, which is essential to ensure the collection of data for informing treatment and prevention strategies that are effective and safe for AYAs. The strategies proposed in this consensus statement may be relevant to a wide range of other research topics beyond HIV, with potential to inform and improve research practices in other areas involving AYAs, such as mental health, sexual and reproductive health, and beyond. Further collaboration will be needed to assess the utility of this guidance in diverse LMIC settings.

The finalized consensus statement, including the preamble, glossary of terms, and open-access resources, are available in the eResults in the Supplement.

Ethical Considerations in Pediatric Surgery: Discussing Informed Consent, Parental Rights, and Decision-Making in Complex Cases
Sahir Prasenjit Telang
Journal of New Century Innovations, 12 April 2025
Abstract
Ethical aspects in pediatric surgery represent a special area of medical practice where the interests of the child, parents, and medical professionals intersect. The purpose of this study is to analyze modern approaches to informed consent, parental rights, and decision-making in complex clinical situations. The study involved 450 pediatric surgeons and 320 parents from five multidisciplinary hospitals in Europe and Central Asia. The obtained data showed that only 37% of doctors involve children over 12 in the decision-making process, despite the recommendations of international organizations. In 64% of cases, doctors encountered disagreements from parents, and 17% of such situations required intervention from the ethics committee or judicial authorities. Significant cultural differences were also identified: in Central Asia, parental opinion dominance was noted in 83% of cases, compared to 51% in European clinics (p<0.01). The results highlight the need to develop unified protocols, improve the effectiveness of ethics committees, and implement medical ethics programs in the educational process. Strengthening the role of joint decision-making, taking into account the child’s opinion, can improve the ethical stability and quality of medical care in pediatric surgery.

Editor’s note: The Journal of New Century Innovations is published in Uzebekistan.

Pediatric Acute Appendicitis as a Model for Shared Decision-Making
Book Chapter
Lindsay A. Gil, Loren Berman, Peter C. Minneci
Difficult Decisions in Pediatric Surgery, 28 March 2025 [Springer]
Abstract
Shared Decision-Making (SDM) in pediatric surgery is challenging given that the treatment decision typically involves three parties (surgeon, caregiver, and patient), and at least one of the treatment choices usually involves an operative intervention. There has been mounting evidence to support the safety and efficacy of non-operative management of pediatric uncomplicated acute appendicitis with antibiotics alone, making SDM an essential and valuable tool for pediatric surgeons. This chapter highlights both the importance and challenges of applying SDM in pediatric surgery by exemplifying its application to the treatment choice between non-operative and operative management of pediatric uncomplicated acute appendicitis. The appendicitis example is one of several in which SDM has the potential to reduce healthcare resource utilization and costs by increasing uptake of non-operative conservative treatments.

Ethical Considerations in the Surgical Care of Children: Balancing the Interests of the Child, the Family, and the Surgeon
Book Chapter
Johnathan Kent, Miranda Ortega, Manish Tushar Raiji
Difficult Decisions in Pediatric Surgery, 28 March 2025 [Springer]
Abstract
Pediatric surgeons take part in the care of children across a wide spectrum of development and maturity. The relationships between patients, their families, and their surgeons can form an inclusive and supportive team to help children navigate complex health concerns. However, these relationships can also form the basis of complex ethical challenges. The care of children involves an understanding of the development of a child’s maturity and subsequent ability to participate in medical decision making. Under specific circumstances, adolescents can become fully independent to make medical decisions. But in the vast majority of instances, children and adolescents require surrogate decision makers to choose for them. This chapter explores several of the tensions that may arise when considering medical and surgical care for children.

Editor’s note: We note  the authors’ assertion that “…in the vast majority of instances, children and adolescents require surrogate decision makers…” We express concern about the imprecision and underlying assumptions of this assertion and continue to examine issues around assent, capacity and children’s rights in our Center for Informed Consent Integrity work.

Navigating consent and dissent in early childhood research: An Australian perspective
Katie Fielding, Karen Murcia, Madeleine Dobson, Geoffrey Lowe
Issues in Educational Research, March 2025; 35(1)
Open Access
Abstract
Notions of consent, including assent and dissent, are paramount ethical considerations in human research, but have different connotations in research involving young children (aged 3 to 8). While discussion surrounding consent in the early childhood literature has progressed from paternalistic views surrounding the need to protect the child, to recognising their capacity to make decisions in line with their rights, needs and interests, some studies suggest that the application of this change may still be problematic in practice. Many researchers still grapple with notions of who provides consent, what consent may look like, and how it is applied both before and during research. This article reports on the practical application of consent, framed by the hierarchy of Children’s Participation Rights (Mayne et al., 2018), within a study into young children’s demonstration of creative thinking behaviours when using digital technologies. It provides a brief overview of contemporary views of children’s rights and consent for context before outlining the study itself and how consent was applied throughout, informed by the Mayne et al. (2018) framework. It presents a series of vignettes describing elements of consent as they arose in practice and discusses them in relation to the literature. The article concludes by considering rights-based consent in contemporary early childhood research in terms of study design for future researchers to consider.

Reimagining Assent: When Things Get Lost in Translation in International Pediatric Research
Original Article
Sarosh Saleem
Asian Bioethics Review, 28 February 2025
Abstract
The necessity of obtaining pediatric assent for research participation is well established within international ethical guidelines. However, the effective implementation of these guidelines poses significant challenges for research ethics committees in numerous developing countries, such as Pakistan, characterized by diverse cultural and socio-economic contexts. This paper critically examines the moral underpinnings of assent, rooted in the principle of respect for persons, which aims to empower, engage, and educate children involved in research processes. Through a case example, this paper reveals the unique obstacles faced by researchers and clinicians in Pakistan, which stem from socio-cultural norms and economic disparities. Such challenges endanger the ethical foundation of assent, creating a disconnect between its philosophical basis and practical execution. Although international guidelines permit contextual adaptation of assent procedures, such flexibility is not adequately articulated within the guidelines, nor is it typically prioritized in practice. This gap undermines the purpose of assent and inadvertently increases the risk of harm to child participants—not from the research itself but rather from a process designed to protect and empower them. This paper emphasizes greater awareness among stakeholders regarding these challenges, urging a reimagined assent process in diverse global contexts. By introducing a clear rationale within research guidelines, the intent is to ensure that researchers and Institutional Review Boards (IRBs) prioritize the contextual understanding of assent, transforming it from a mere procedural formality into a meaningful practice that mitigates potential risks to children and adolescents involved in research.

Editor’s note: We take special note of this article for both its treatment of assent and its application of various guidelines in different cultural contexts.

Consenting for themselves: A qualitative study exploring a Gillick Competence assessment to enable adolescents to self-consent to low-risk online research
Maria Loades, Lara Willis, Emma Wilson, Grace Perry, Melanie Luximon, Christy Chiu, Nina Higson-Sweeney
BMJ Open, 13 February 2025
Abstract
Background
Providing digital mental health interventions online could expand access to help for young people, but requiring parental consent may be a barrier to participation. We therefore need a method that enables young people <16 years old (i.e. presumed competent in the UK) to demonstrate Gillick Competence (understanding of purpose, process, potential benefits, and potential harms) to self-consent to online, anonymous, low-risk studies.
Aim
To explore whether a new method for assessing Gillick Competence to participate in low risk, anonymous online studies is acceptable to both young people and parents.
Method
We interviewed 15 13–15-year-olds and 12 parents of this age group in the UK. Using a qualitative approach, we explored the acceptability of a series of multiple-choice questions (MCQs) designed to assess understanding of a specific online self-help research study testing a self-kindness intervention.
Results
The MCQ answers that participants gave mostly corresponded with their narrative explanations of their understanding during interviews. Young people and parents thought that the process was empowering and could increase access to research whilst also promoting independence. However, they emphasised the importance of individual differences and different research contexts and highlighted the need for safeguards to be in place.
Conclusions
The MCQs were acceptable to both young people and parents, providing preliminary evidence for the potential of this process for allowing <16’s to self-consent to online, anonymous, low-risk mental health research. Further research is needed to validate the effectiveness of this process among a diverse range of populations and research contexts.

Between Protection and Participation: Informed Consent, Ethics and Play in Research With Children and Youth
Original Article
Maria V. Barbero
Children & Society, 11 February 2025
Abstract
While a robust scholarly dialogue has emerged in recent decades surrounding child and youth-centred research methods, less attention has been paid to how other elements of research design can better account for the needs, vulnerabilities, and perspectives of children and youth. In this article, I discuss challenges tied to informed consent processes and inflexible ethical guidelines in social science research with minors. Drawing from the child and youth studies literature as well as my past research experiences, I explore what it means to develop ethical approaches that are situated, responsive, and relational and which focus not only on the protection of minors but also their inclusion and full participation in research. In doing so, I develop the concept of “playful consent checkpoints” and argue that playful approaches can offer interesting and flexible possibilities for responding to ongoing ethical challenges in research with young people.

Ascribed Agency, Denied Influence: How Adult Narratives Shape and Constrain the Right of Children in the Justice System to be Heard
Mark Yin
The International Journal of Children’s Rights, 17 December 2024
Abstract
Following McMellon and Tisdall’s (2020) literature review on children’s participation rights, as embodied in the Convention on the Rights of the Child, Article 12, this narrative review considers how access to these rights is affected by children’s involvement in the criminal justice system. Based on 30 papers relating to youth participation in youth justice, it is argued that adult-driven narratives of criminalised children as “risky”, “self-interested” or “vulnerable” variously undermine their right to be heard, while children’s narratives about themselves are often neglected. This suggests that the “perennial” implementation solutions identified by McMellon and Tisdall belie more fundamental questions about the very idea of childhood – as exemplified by children in conflict with the law – which warrant their own analysis.