Operationalization of assent for research participation in pre-adolescent children: a scoping review
Research
Florence Cayouette, Katie O’Hearn, Shira Gertsman, Kusum Menon
BMC Medical Ethics, 3 November 2022; 23(106)
Open Access
Abstract
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 term “assent” in the title or abstract. Inclusion criteria were (1) studies enrolling children which specifically described operationalization of the assent process and (2) studies of the assent process which provided a description of assent. Data collected included participant information, patient criteria for seeking assent, guidelines referenced, description of assent reported, how assent was obtained and assent information presented, and reported assent rate. For qualitative articles focusing on the assent process, important themes were identified.
Results
A total of 116 articles were included of which 79 (68.9%) operationalized assent and 57 studies (%) described the assent process. The most commonly reported criterion used to determine the ability of a child to assent was age (35.4%, 28/79). The reported minimal age for obtaining pediatric assent varied considerably across and within jurisdictions (5–13 years; median 7.5 years, IQR 7.0, 9.75). Cognitive ability was reported as a criterion for obtaining assent in 5.1% (4/79) of studies. Assent rates were only reported in 17.7% (14/79) of citations and ranged from 32.0 to 100%. Analysis of the 57 studies describing the assent process identified several themes, including age thresholds, assessment of capacity, variable knowledge of pediatric assent and parental roles.
Conclusion
We found significant variation in criteria used for assessment of patient capacity, delivery of information used to obtain assent and documentation of the assent process. While we acknowledge that individual children, settings and jurisdictions may require different approaches to obtaining assent, there should be agreement on important principles to be followed with resulting common guidance on assessing capacity, delivering information and documentation of the assent process for publication.

Parental Preferences Surrounding Timing and Content of Consent Conversations for Clinical Germline Genetic Testing Following a Child’s New Cancer Diagnosis
Original Reports
Belinda N. Mandrell, Liza Marie Johnson, Mary Caples, Jami Gattuso, Jamie L. Maciaszek, Roya Mostafavi, Katianne M. Howard Sharp, Kim E. Nichols
JCO Precision Oncology, 20 October 2022
Abstract
Purpose
Clinical genomic testing is increasingly being used to direct pediatric cancer care. Many centers are interested in offering testing of tumors and paired germline tissues at or near the time of cancer diagnosis. We conducted this study to better understand parent preferences surrounding timing and content of consent conversations for clinical germline genetic testing of their children with cancer as a part of real-time cancer care.
Patients and Methods
A seven-question survey developed by the Division of Cancer Predisposition and collaborators at St Jude Children’s Research Hospital (St Jude) was distributed to members of the St Jude Patient Family Advisory Council, which included parents of childhood cancer survivors and bereaved parents whose children with cancer had died. Parents were asked to provide free text comments after each question. Qualitative methods were used to derive codes from parent comments, and survey results were depicted using descriptive statistics.
Results
The survey was completed by 172 parents. Ninety-three (54%) endorsed an approach for consent conversations ≥ 1 month after cancer diagnosis, whereas 58 (34%) endorsed an approach at 1-2 weeks and 21 (12%) at 1-2 days. Needing time to adjust to a new or relapsed cancer diagnosis and feeling overwhelmed were frequent themes; however, parents acknowledged the urgency and importance of testing. Parents desired testing of as many cancer-related genes as possible, with clinical utility the most important factor for proceeding with testing. Most parents (75%) desired germline results to be disclosed in person, preferably by a genetic counselor.
Conclusion
Parents described urgency and benefits associated with germline testing, but desired flexibility in timing to allow for initial adjustment after their child’s cancer diagnosis.

Editor’s note: JCO is an American Society of Clinical Oncology Journal.

Children’s understanding and consent to heart surgery: Multidisciplinary teamwork and moral experiences
Priscilla Alderson, Hannah Bellsham-Revell, Nathalie Dedieu, Liz King, Rosa Mendizabal, Katy Sutcliffe
Journal of Child Health Care, 27 September 2022
Abstract
Mainstream law and ethics literature on consent to children’s surgery contrasts with moral experiences of children and adults observed in two heart surgery centres. Research interviews were conducted with 45 practitioners and related experts, and with 16 families of children aged 6 to 15, admitted for non-urgent surgery, as well as an online survey. Thematic data analysis was informed by critical realism and childhood studies.Impersonal adult-centric mainstream literature assumes young children cannot consent. It is based on dichotomies: adult/child, competent/incompetent, respect or protect children, inform or distract them, use time swiftly or flexibly, verbal/non-verbal communication, respect or control children and reason/emotion.Through their moral experiences, adults and children resolve these seeming dichotomies. Through understanding young children’s reasoning and emotions about complex distressing decisions related to heart surgery, adults share knowledge, control, trust and respect with them. They see children’s consent or refusal before non-urgent surgery as a shared personal moral experience within the child’s life course, beyond mere legal compliance. Adults help children to understand and ‘want’ the surgery that offers things they value: better health or to ‘be more like their friends’. If children are not convinced, sometimes surgery is postponed or occasionally cancelled.

Readability and comprehension of paediatric informed consent and assent forms from a single institution in South Africa
Mwanaidi Kafuye, Mariana Kruger
Tanzania Journal of Health Research, 2022; 23 pp 39-39
Abstract
Background
Informed consent and assent forms are fundamental prerequisites in the conduct of ethical paediatric health research. For paediatric research, parents or the legal caretaker of a child should provide informed consent along with the child or adolescent. Readability and comprehension of consent and assent forms in both therapeutic and non-therapeutic studies play a critical role during the informed decision-making process of study participants.
Objectives
To assess the readability scores and to determine the school grade level of informed consent forms (ICFs), and informed assent forms (IAFs) also to assess accuracy and completeness of elements of ICFs and IAFs.
Methods
We used web-based readability score calculator to determine scores of Flesch Kincaid Reading Ease (FRE), Flesch-Kincaid Grade Level (FKGL) and length (word count) of the assent and consent forms, respectively. We also assessed inclusion of essential elements in the ICFs and IAFs using consent form guidance available in the South African Department of Health: Ethics in Health Research Guidelines (2015) as standard.
Results
The mean Flesch Kincaid readability ease score for 28 ICFs was 57 while that of the23 IAFs was 68. Furthermore, the higher the Flesch Kincaid Reading Ease scores the lower was the Flesch-Kincaid Grade Level score (p < 0.001). The therapeutic ICF and IAF forms were substantially longer than the non-therapeutic ICF and assent forms (p < 0.001). Most ICFs and IAFs provided accurate and complete elements of ICF with regards to research information with adherence to the Ethics guideline of the South African Department of Health.
Conclusion and recommendations
There were higher word counts in both ICFs and IAFs for therapeutic studies versus non-therapeutic studies. The study concludes that both ICFs and IAFs were difficult to comprehend with significantly higher Flesch Kincaid reading grade levels than the NIH/AMA/USDHHS recommended reading grade level 6.

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, 19 August 2022; 13(1)
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 lagging 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.

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.