Developmental Stages and Patient Assent for Research Studies or Medical Treatment
Rachel Y. Moo
American Academy of Pediatrics Journal Blogs, 17 August 2022
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
Pediatrics Perspectives, 17 August 2022
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
Zoe Atsaidis, Ryan Antel, Elena Guadagno, Jeffrey Wiseman, Dan Poenaru
Journal of Pediatric Surgery, 11 August 2022
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.
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.
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.
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
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
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)
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
Flavia Andrade Nunes Fialho, Ieda Maria Ávila Vargas Dias, Marisa Palacios de Almeida Rego
Revista Bioética, April – June 2022; 30(2)
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.
Parental informed consent comprehension in childhood cancer clinical trials: Associations with social determinants of health
Paula Aristizabal, Shilpa Nataraj, Bianca Perdomo, Elena Martinez, Jesse Nodora, Courtney D Thornburg
Journal of Clinical Oncology, 1 June 2022 [2022 ASCO Annual Meeting]
Adequate informed consent (IC) comprehension is an ethical right prior to participation in clinical trials. Research investigating IC comprehension and associations with social determinants of health (SDoH) is lacking. We assessed whether SDoH and related contextual factors were associated with parental IC comprehension in therapeutic childhood cancer clinical trials.
We prospectively enrolled parents of children with newly-diagnosed cancer. Univariable and multivariable regression were used to assess whether objective IC comprehension and related domains (Purpose/Procedures/Randomization, Risks/Benefits, Alternatives, and Voluntariness) were associated with SDoH (ethnicity, marital status, language, education attainment, employment, insurance, socio-economic status, health literacy [HL]) and contextual factors (cancer type, voluntariness, satisfaction with IC).
Of 223 parents included, 112 (50%) were Hispanic and 38% of Hispanics were monolingual Spanish-speaking. In adjusted multivariable analyses, limited HL was significantly associated with lower overall IC comprehension (β = -7.22; 95% CI, -10.9 to -3.59; P < 0.001) and lower comprehension of Purpose/Procedures/Randomization (β = -7.53; 95% CI, -11.3 to -3.73; P < 0.001), Risks/Benefits (β = -8.14; 95% CI, -15.5 to -0.772; P = 0.031), and Alternatives (β = -17.0; 95% CI, -30.5 to -3.57; P = 0.013). Preferred Spanish language of written/verbal medical information was significantly associated with lower comprehension of Purpose/Procedures/Randomization (β = -8.50; 95% CI, -15.1 to -1.89; P = 0.012) and Voluntariness (β = -20.1; 95% CI, -34.9 to -5.33; P = 0.008). Lower satisfaction with informed consent (β = 0.988; 95% CI, 0.460 to 1.52; P < 0.001) and single marital status (β = -4.42; 95% CI, -7.81 to -1.02; P = 0.011) were significantly associated with lower IC comprehension.
Among parents of children with newly diagnosed cancer who provided consent for their child’s participation in a therapeutic clinical trial, limited HL was consistently associated with lower IC comprehension in all domains analyzed, except for Voluntariness. Spanish language preference for medical information was associated with lower comprehension of two domains; and lower satisfaction was associated with lower overall IC comprehension. These findings suggests that parents with limited HL, limited English-proficiency, and lower satisfaction may not fully comprehend the IC and thereby not truly make informed decisions. Our findings highlight the potential role of language-concordant interventions tailored to the participant’s HL level in order to ultimately improve IC comprehension and contribute to a reduction of disparities in clinical trial participation and promote equitable translation of discoveries and treatments to underserved groups.
Should Children Be Enrolled in Clinical Research in Conflict Zones?
Case and Commentary
Dónal O’Mathúna, Nawaraj Upadhaya
AMA Journal of Ethics, June 2022
This commentary examines 4 ethical issues in a case of clinicians considering conducting research on children in conflict zones: (1) whether any time or resources should be taken away from treating acute injuries in order to conduct research; (2) obtaining consent for children to participate in research, which is particularly challenging given that children can be separated from parents or guardians; (3) whether the research is feasible at the moment, since starting research that stands little chance of being completed is ethically questionable; and (4) maintaining neutrality, impartiality, and humanity. Research that puts participants and researchers at risk of additional harm must be considered carefully. Here, we propose that both research and clinical care might occur simultaneously when researchers engage humbly with involved communities as the research is being designed, conducted, and reported in order to understand and resolve ethical issues involved.
Relational ethics, informed consent, and informed assent in participatory research with children with complex communication needs
Leni Van Goidsenhoven, Elisabeth De Schauwer
Developmental Medicine & Child Neurology, 28 April 2022
There is a need for qualitative participatory research involving children with intellectual disability and complex communication needs (CCNs), but procedural ethics cannot always adequately respond to the associated realities. To tackle this challenge, procedural ethics can be expanded with relational ethics to engage with consent and assent practices in participatory research projects. By drawing on several key incidents of participatory research with children with CCNs, we explore the complex moral spaces and times of ambivalent and iterative (dis)engagements within research processes. We reconceptualize the consent/assent terrain as a relationally constituted process, more aligned with the overall epistemological frameworks of participatory research and ensuring (disabled) children’s ongoing and meaningful involvement in research.
Cultural considerations for informed consent in paediatric research in low/middle-income countries: a scoping review
Marcela Colom, Peter Rohloff
BMJ Paediatrics Open, 5 December 2018; 2
Conducting research with children in low/middle-income countries (LMIC) requires consideration of socioeconomic inequalities and cultural and linguistic differences. Our objective was to survey the literature on informed consent in paediatric LMIC research, assessing for practical guidance for culturally and linguistically appropriate procedures.
We conducted a scoping review on informed consent in paediatric LMIC research searching the PubMed, Web of Science and PsycINFO databases. Eligible articles were published in English, from any date range, of any study design or format.
The search identified 2027 references, of which 50 were included in the analysis following full-text review. Reviewed guidelines emphasised individual, informed and voluntary consent from parents and caregivers. Reviewed articles provided detailed practical guidance on adapting these guiding principles to LMIC settings, including considerations for community engagement, verbal or other alternative consent procedures for low-literacy settings or less commonly spoken languages and guarding against therapeutic misconception by caregivers. There was uncertainty, however, on how to best protect individual autonomy, especially when influenced by gender dynamics, leadership hierarchies or the social status of researchers themselves. There was, furthermore, limited research discussing the special case of research involving adolescents or of procedures for documenting assent by participating children.
A scoping review of paediatric research in LMICs revealed substantial guidance on several features of culturally appropriate informed consent. However, additional research and guidance is needed, especially in the areas of gender imbalances, research with adolescents and children’s own assent to participate in research.