Developmental Stages and Patient Assent for Research Studies or Medical Treatment
Rachel Y. Moo
American Academy of Pediatrics Journal Blogs, 17 August 2022
Excerpt
    As a pediatrician and a clinical researcher, I am well aware of the requirements of when we need to obtain parental consent, and when a child needs to assent, meaning the child needs to agree.

In general, we talk about child assent for clinical studies, but there are times when medical treatment and enrollment in a clinical study are one and the same. For instance, most children with cancer are automatically enrolled in a clinical study, because we are still learning the best way to treat many of these cancers. And many children with cancer are alive today because of those before them who entered into these studies.

But what does it mean to get assent from a child?

This week, Pediatrics is early releasing a Pediatrics Perspectives by Gianna McMillan, a parent and bioethicist at Loyola Marymount University, entitled “The Parent’s Dilemma: Pediatric Assent in Research”.

Dr. McMillan helps us understand that assent means different things at different developmental stages. At some stages, the parent should make the decision, with or without the child’s input (again, depending on the child’s developmental stage). As the child becomes more developmentally mature, it may become appropriate for the child to make the decision, with parental agreement…

The Parent’s Dilemma: Pediatric Assent in Research
Gianna McMillan
Pediatrics Perspectives, 17 August 2022
Excerpt
Parents and their children rarely understand what it means “to consent” to participate in pediatric clinical research. This became clear during my 15 years as a patient advocate, when I facilitated hundreds of conversations about the implications of aggressive treatment of the very young and the existential crises faced by parents who made life-or death decisions for their children. In the United States, most children with cancer enter a clinical trial,1 and although parents understand enough of the scientific information to deliberate on the pros and cons of research, it is harder to grasp the subtleties of “consenting for” experimental studies, “giving permission to” the investigators, or “gaining assent from” the child. This lack of clarity leaves parents confused about the ethical weight and propriety of their decisions or unaware of any ethical significance at all…

Understanding the Effectiveness of Consent Processes and Conversations in Pediatric Surgery: A Systematic-Scoping Review
Review Article
Zoe Atsaidis, Ryan Antel, Elena Guadagno, Jeffrey Wiseman,  Dan Poenaru
Journal of Pediatric Surgery, 11 August 2022
Abstract
Background
The consent conversation in pediatric surgery is an essential part of pre-operative care which, when inadequate, can lead to significant adverse consequences for the child, parents, surgeon, other healthcare workers and the healthcare system. We reviewed the published literature on what key stakeholders perceive are the components of effective and ineffective consenting processes in pediatric surgery.
Methods
A medical librarian searched seven databases to retrieve articles looking at the informed consenting process in surgical care for the pediatric population. Two independent reviewers screened all publications and categorized them by stakeholder perspectives (patient/family, surgical team, other healthcare team, and hospital administration or policy maker). General study characteristics, interventions to improve consent and features of effective and ineffective consent conversations were extracted.
Results
5079 titles and abstracts were screened, resulting in 88 full-text studies and 43 articles included in the final review. Most publications (51%) discussed informed consent only from the patient/family perspective, while 21% added surgeon’s perspective. No study approached the consenting process from the perspective of all stakeholder groups. Effective consent components identified included use of multimedia, presence of multiple conversations prior to surgery, and individualized communication catered to unique family knowledge and needs. In contrast, ineffective conversations did not include a clear assessment of parental understanding, delivered too much information, and did not address parental anxiety.
Conclusions
The literature on the consenting process in pediatric surgery is narrow in stakeholder perspectives. Our findings highlight gaps in the literature and opportunities to improve the informed consent processes prior to pediatric surgery.

The Role of Formal Policy to Promote Informed Consent of Psychotropic Medications for Youth in Child Welfare Custody: A National Examination
Original Article
Thomas I. Mackie, Ana J. Schaefer, John S. Palatucci, Laurel K. Leslie, Stephen Crystal, Michael Gusmano, Hannah E. Karpman
Administration and Policy in Mental Health and Mental Health Services Research, 6 August 2022
Open Access
Abstract
Active participation of youth and surrogate decision-makers in providing informed consent and assent for mental health treatment is critical. However, the procedural elements of an informed consent process, particularly for youth in child welfare custody, are not well defined. Given calls for psychotropic medication oversight for youth in child welfare custody, this study proposes a taxonomy for the procedural elements of informed consent policies based upon formal and informal child welfare policies and then examines whether enacted state formal policies across the United States endorsed these elements. A sequential multi-method study design included: (1) semi-structured interviews with key informants (n = 58) primarily from state child welfare agencies to identify a taxonomy of procedural elements for informed consent of psychotropic medications and then (2) a legislative review of the 50 states and D.C. to characterize whether formal policies endorsed each procedural element through February 2022. Key informants reported five procedural elements in policy, including how to: (1) gather social and medical history, (2) prescribe the medication, (3) authorize its use through consent and youth assent, (4) notify relevant stakeholders, and (5) routinely review the consenting decision. Twenty-three states endorsed relevant legislation; however, only two states specified all five procedural elements. Additionally, the content of a procedural element, when included, varied substantively across policies. Further research and expert consensus are needed to set best practices and guide policymakers in setting policies to advance transparency and accountability for informed consent of mental health treatment among youth in child welfare custody.

Ethical issues concerning the use of commercially available wearables in children: Informed consent, living in the spotlight, and the right to an open future
Andrie G. Panayiotou, Evangelos D. Protopapadakis
European Journal of Bioethics, July 2022; 13(25)
Open Access
Summary
Wearable and mobile technology has advanced in leaps and bounds in the last decade with technological advances creating a role from enhancing healthy living to monitoring and treating disease. However, the discussion about the ethical use of such commercial technology in the community, especially in minors, is lacking behind. In this paper, we first summarize the major ethical concerns that arise from the usage of commercially available wearable technology in children, with a focus on smart watches, highlighting issues around the consent process, mitigation of risk and potential confidentiality and privacy issues, as well as the potential for therapeutic misconceptions when used without medical advice. Then through a relevant thought experiment we move on to outline some further ethical concerns that are connected to the use of wearables by minors, to wit the issue of informed consent in the case of minors, forcing them to live in the spotlight, and compromising their right to an open future. We conclude with the view that mitigating potential pitfalls and enhancing the benefits of wearable technology especially for minors requires brave and comprehensive moral debates.

Consent forms: the participation of children in research
Research
Flavia Andrade Nunes Fialho, Ieda Maria Ávila Vargas Dias, Marisa Palacios de Almeida Rego
Revista Bioética, April – June 2022; 30(2)
Abstract
The Resolution 466/2012 of the National Council of Health establishes the term of assent as compulsory for research carried out with children. However, the resolution presents the definition of assent without specifying the terms necessary for the document. This gap makes current and pertinent the approach of this topic by this study, which aims to discuss the participation of children in research. The results present a theoretical framework from which we can reflect on the ethics of Research with children, considering their vulnerability, which can lead to irreparable situations. We conclude that the theme must remain in the academic and professional debates since, on top of being a dynamic reality, this population segment has many specificities.

Editor’s note: This abstract refers to the National Council of Health in Brazil.