Ethical considerations cited in child health research published in leading nursing journals : 2015-2019
Y Wu, ML Howarth, C Zhou, L Yang, X Ye, R Wang, C Li, M Hu, W Cong
International Journal Of Nursing Practice, 24 August 2020
Abstract
Background: Child health research comprises complex ethical considerations. Understanding the extent to which the ethical process is reported in child health research is needed to improve reporting. Aims: To identify reportage of ethical considerations in child health research in leading nursing and paediatric journals. Methods: All child health research published between 2015 and 2019 in ten leading nursing journals and two paediatric journals were retrieved and critically appraised for the reportage of informed consent and ethical approval. Results: Eight hundred and fifty-one child health research papers were included. Whilst 544 (79.9%) of the prospective studies mentioned informed consent, only 300 (55.2%) reported that written informed consent was obtained from the participants. Overall, 748 (87.9%) of child health research papers noted obtaining research ethics committee approval. Articles that mentioned financial support were significantly more likely to report informed consent and ethical approval than unfunded studies (all P<0.001). Prospective studies showed higher rates of reportage of ethical approval compared to retrospective studies (P=0.027). Rates of child consent (assent) obtained in different age groups of children ranged from 29.6% to 66.3%. Conclusion: Despite improvements in the reportage of ethical review and approval processes in child health research, consistent and transparent reports are still lacking.

Opt-out consent in children’s emergency medicine research
T Long, A Rowland, S Cotterill, SR Woby
Comprehensive Child and Adolescent Nursing, 17 August 2020
Abstract
There is global acceptance that individuals should be allowed to decide whether or not to take part in research studies, and to do so after being informed about the nature of the research and the risk that might attach to participation. The process of providing detailed information before seeking consent (formalised by signatures) in advance of undertaking research procedures may not be possible in some circumstances, and sometimes an amended approach may be adopted. The use of opt-out consent has been recognised as a valid and ethical means of recruiting participants to studies particularly with large samples and where the risk to participants is small. However, it is sometimes misunderstood and can be a problematic factor in being accepted by research ethics committees and governing authorities. This may be due partly to differing expectations of the amount of information and support offered, together with the nature of the process that is adopted to ensure that a decision has been made rather than consent simply being assumed. In accordance with ongoing discussions with young people, and following consultation with parents, an opt-out consent strategy including varied means of providing information was employed in a large study of 44,501 cases of children attending emergency or urgent care departments. The study was conducted over more than 12 months in dissimilar emergency departments and an urgent care unit, and was designed to support better decision-making in paediatric emergency departments about whether children need to be admitted to hospital or can be discharged home safely. Robust analysis of the factors that exerted the greatest impact on predicting the need to admit or the safety of discharging children led to a revised version of a an existing tool. In this article we review approaches to consent in research, the nature and impact of opt-out consent, the factors that made this an effective strategy for this study, but also more recent concerns which may make opt-out consent no longer acceptable.

Informed consent approaches for clinical trial participation of infants with minor parents in sub-Saharan Africa: A systematic review
Research Article
Angela De Pretto-Lazarova, Domnita Oana Brancati-Badarau, Christian Burri
PLOS One, 4 August 2020
Abstract
Background
Regulations are vague regarding the appropriate decision-maker and authority to consent for children of minor parents participating in clinical trials. In countries with high rates of underage mothers, such as in sub-Saharan Africa, this lack of guidance may affect the rights of potential paediatric participants already bearing increased vulnerability. It can also influence the recruitment and generalizability of the research. We provide evidence and discuss informed consent management in such cases to inform best practice.
Materials and methods
We searched PubMed/MEDLINE, Embase, CINAHL, and Google Scholar for articles published up to March 2019. In total, 4382 articles were screened, of which 16 met our inclusion criteria. Studies addressing informed consent in clinical trials involving children with minor parents in sub-Saharan Africa were included. We performed descriptive and qualitative framework analyses. The review was registered in PROSPERO: CRD42018074220.
Results
Various informed consent approaches were reported. Articles supporting individual consent by minor parents based on emancipation or “mature minor” status lacked evidence in the context of research. National laws on medical care guided consent instead. When no laws or guidance existed an interpretation of the local decision-making culture, including community engagement and collaboration with local ethics committees, defined the informed consent approach.
Conclusions
The review emphasises that the implementation of informed consent for children with minor parents may be variable and hampered by absent or ambiguous clinical trial regulations, as well as divergent local realities. It may further be influenced by the research area and study-specific risks. Clear guidance is required to help address these challenges proactively in clinical trial planning. We provided a set of questions to be considered in the development of an ethically acceptable informed consent approach and proposed information that should be integrated into international clinical trial guidelines.

Assessing Parent Decisions About Child Participation in a Behavioral Health Intervention Study and Utility of Informed Consent Forms
Stephanie A. Kraft,  Kathryn M. Porter,  Devan M. Duenas,  Erin Sullivan,  Maya Rowland,  Brian E. Saelens,  Benjamin S. Wilfond, Seema K. Shah
JAMA, 31 July 2020
Open Access
Abstract
Importance  
Obtaining informed consent is an important ethical obligation for clinical research participation that is imperfectly implemented. Research on improving consent processes often focuses on consent forms, but little is known about consent forms’ influence on decision-making compared with other types of engagement.
Objective  
To evaluate whether parents decide whether to enroll their children in research before or after they receive the consent form.
Design, Setting, and Participants  
An online survey of 88 parents who enrolled or declined to enroll their child in a weight management intervention study between January 2, 2018, and June 24, 2019, was conducted; surveys were completed between February 2, 2018, and July 9, 2019. A 31-item survey asked about impressions of the study throughout the enrollment process, timing of enrollment decisions, and decision-making factors. Responses were summarized descriptively and subgroups were compared using the Fisher exact test or χ2 test.
Main Outcomes and Measures  
Self-reported timing of enrollment decision.
Results  
A total of 106 parents were approached and gave permission for their contact information to be shared with the study team; 22 additional parents declined to allow their information to be shared, and 24 lost contact with the partner study before they could be asked for permission. A total of 88 parents (67 enrollees, 21 decliners) completed the survey (83% participation rate); 79 of 88 reporting gender (instead of sex, as biological sex was not relevant to survey) information were women (91%), 66 participants (75%) were non-Hispanic White, and 63 participants (72%) had annual household incomes greater than or equal to $70 000. No significant differences in respondent characteristics between enrollees and decliners were identified. Fifty-nine parents (67%) responded that they decided whether to enroll in the weight management study before receiving the consent form. Only 17 of 69 parents (25%) who remembered receiving the consent form responded that it taught them new information.
Conclusions and Relevance  
The findings of this study suggest that interventions to improve informed consent forms may have limited influence on decision-making because many research decisions occur before review of the consent form. It appears that regulatory review and interventions to improve decision-making should focus more on early engagement (eg, recruitment materials). Future studies should test timing of decisions in other types of research with different populations and clinical settings.

Adolescent Barriers to HIV Prevention Research: Are Parental Consent Requirements the Biggest Obstacle?
Original Article
Seema K. Shah, Zaynab Essack, Katherine Byron, Catherine Slack, Daniel Reirden, Heidi van Rooyen, Nathan R. Jones, David S. Wendler
Journal of Adolescent Health, 5 July 2020
Abstract
Purpose
One third of people newly living with HIV/AIDS are adolescents. Research on adolescent HIV prevention is critical owing to differences between adolescents and adults. Parental permission requirements are often considered a barrier to adolescent enrollment in research, but whether adolescents view this barrier as the most important one is unclear
Methods
Adolescents were approached in schools in KwaZulu-Natal, South Africa, and at a sexually transmitted infection clinic at the Children’s Hospital of Aurora, Colorado. Surveys with a hypothetical vignette about participation in a pre-exposure prophylaxis trial were conducted on smartphones or tablets with 75 adolescents at each site. We calculated descriptive statistics for all variables, using 2-sample tests for equality of proportions with continuity correction. Statistical significance was calculated at p < 0.05. Multivariate analyses were also conducted.
Results
Most adolescents thought side effects (77%) and parental consent requirements (69%) were very important barriers to research participation. When asked to rank barriers, adolescents did not agree on a single barrier as most important, but the largest group of adolescents ranked parental consent requirements as most important (29.5%). Parental consent was seen as more of a barrier for adolescents in South Africa than in the United States. Concerns about being experimented on or researchers’ mandatory reporting to authorities were ranked much lower. Finally, most (71%, n = 106) adolescents said they would want to extra support from another adult if parental permission was not required.
Conclusion
Adolescents consider both parental permission requirements and side effects important barriers to their enrollment in HIV prevention research. Legal reform and better communication strategies may help address these barriers.

Designing a Solution to Manage Electronic Consent for Children
Gary Leeming , Sarah Thew, John Ainsworth
Studies in health technology and informatics, 16 June 2020; 270 pp 1103-1107
Abstract
Electronic systems for managing consent do exist but are generally only able to record consent from the research subject directly. Consent for research is also challenging to integrate into many electronic patient record systems. The Born In Bradford study is a large, from birth cohort study in the North of England which requires consent to be recorded by the pregnant mother of a child who will be included in the study from birth. This creates a complex challenge for consent management that has previously been achieved through paper-based processes. As the study begins a new phase with the objective of inviting all new parents within the Bradford region to participate in the study the solution also needs to work with existing maternity systems. This paper considers the specific challenges of converting the often grey rules around consent of children into an electronic system that is transparent and supports the trust of both the family and the clinical and care teams recruiting research subjects into a large cohort study, and describes the user centred design and technical approach taken to resolve it.

Is consent causing confusion for clinicians? A survey of child and adolescent Mental health professional’s confidence in using Parental Consent, Gillick Competence and the Mental Capacity Act
Research Article
Clare Fenton
Clinical Child Psychology and Psychiatry, 6 June 2020
Abstract
All professionals engaged in clinical work should be competent to assess consent for the interventions they provide. This study assesses CAMHS clinicians confidence and knowledge in the various forms of consent and the number of minors admitted to mental health units in England under parental consent alone.

An online questionnaire using vignettes of possible scenarios was sent to child and adolescent mental health practitioners in Tees Esk and Wear Valleys Trust. A freedom of information request was used to determine the number of young people admitted through parental consent.

Thirteen of the 20 trusts contacted had no knowledge of the number of young people admitted under parental consent. A total of 93 participants completed the survey. Out of six vignettes, there were two where the majority of responses were discordant with current legal advice. Both of these vignettes considered the use of parental consent for admission to a mental health unit.

This study provides further evidence to indicate that the current consent processes in CAMHS causes confusion for clinicians. There continues to be very few safeguards for children admitted under parental consent, with most trusts in England and Wales having no centralised knowledge of whether this is occurring and the numbers involved if it is.

Racial/ethnic, language, and health literacy disparities on perception of voluntariness during informed consent for pediatric cancer clinical trials
Paula Aristizabal, Arissa MA, Bianca Perdomo, Jesse Nodora, Maria E. Martinez
Eleventh AACR Conference on The Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, 2-5 November 2018; New Orleans, LA
Open Access
Abstract
Background
Valid consent for research requires that the decision for participation be both fully informed and voluntary. Previous studies on informed consent have shown that when presented with a clinical trial for their child, parents often do not understand the many components of informed consent, including voluntariness of participation. In addition, individuals with limited English proficiency have reported lower understanding and satisfaction during informed consent. There is limited research on factors associated with perception of voluntariness during participation in pediatric cancer clinical trials. Our aim was to examine contextual factors associated to perception of voluntariness in parents who had consented to participation of their child in a clinical trial for cancer treatment, focused on characterizing differences between non-Hispanics and Hispanics, as the latter is the fastest-growing ethnic group in the U.S.
Methods
Parents (n=97) of children aged 0-17 years with newly diagnosed cancer, who had consented to participation of their child in a clinical trial for treatment at Rady Children’s Hospital-San Diego, were prospectively recruited. Participants completed questionnaires assessing sociodemographics, health literacy, perception of voluntariness, decisional regret, satisfaction, and acculturation level, if Hispanic. Outcomes and their correlates were analyzed using logistic regression.
Results
Fifty participants (51.5%) were Hispanic and 47 (48.5%) non-Hispanic. We found that parents who were Hispanic compared to non-Hispanics (p<0.001), Spanish-speaking compared to English-speaking (p=0.048), and those with lower health literacy (p<0.001) had lower perception of voluntariness. Decisional regret was overall low and satisfaction was overall high across all subgroups and neither measure was significantly impacted by sociodemographics, health literacy or acculturation.
Conclusions
In this study, with equivalent numbers of Hispanics and non-Hispanics, we found that Hispanic parents of children with newly diagnosed cancer, and particularly Spanish-speakers and those with low health literacy, had inadequate perception of voluntariness. To our knowledge, this is the first study to associate lower health literacy with lower perception of voluntariness in parents of children with newly diagnosed cancer despite overall high rates of satisfaction with the informed consent process for pediatric cancer clinical trials. True voluntariness of participation is essential to the ethical practice of informed consent, and our study suggests that many participants with low health literacy, particularly Hispanics and Spanish-speaking individuals, are not making truly informed decisions. Tailored interventions can improve decision-making, reduce clinical trial participation inequities and, ultimately, eliminate survival disparities by effectively and equally translating discoveries and treatment benefits to diverse populations.

The Importance of Engaging Children in Research Decision‐Making: A Preliminary Mixed‐Methods Study
Erin Talati Paquette, Hannah Palac, Elizabeth Bair, Blake Schultz, Nicole Stenquist, Steven Joffe, Avani Shukla
Ethics & Human Research, 18 May 2020
Abstract
Studies demonstrate deficiencies in parents’ and children’s comprehension of research and lack of child engagement in research decision‐making. We conducted a cross‐sectional and interview‐based study of 31 parent‐child dyads to describe decision‐making preferences, experiences, and comprehension of parents and children participating in research. Parents and children reported that parents played a greater role in decisions about research participation than either parents or children preferred. The likelihood of child participation was associated with the extent of input the parent permitted the child to have in the decision‐making process, the child’s comprehension, whether the study team asked the child about participation, whether the child read study‐related materials, the parent’s marital status, and the child’s race. Children had lower comprehension than adults. Comprehension was related to age, education, verbal intelligence, and reading of study‐related information. Parent understanding was associated with prospect for benefit and illness severity. Child participation may be improved by increasing parent‐child communication, emphasizing important relational roles between parent and child, respecting the developing autonomy of the child, increasing engagement with the study team, providing appropriate reading materials, and assessing comprehension.

‘It’s never okay to say no to teachers’: children’s research consent and dissent in conforming schools contexts
Perpetua Kirby
British Educational Research Journal, 5 May 2020
Abstract
This paper examines the limits to children giving research consent in everyday school contexts that emphasises their conformity to comply with adult expectations, and highlights children’s competence and agency in navigating this conformity through different practices of dissent. It draws on research into children’s agency, using a multimodal ethnography of Year One classrooms in two English primary schools. The paper includes a reflexive methodological focus, exploring the extent to which I counter the schools’ emphasis on conformity. This includes creating visuals for children to practice consent; positioning myself as the researcher in a non-teacher role, as ‘least adult’, and the one who ‘least knows’; and designing interview spaces markedly different from classrooms. The paper examines how children navigate conforming discourses by finding different ways to dissent in the research. Firstly, children demonstrate a sophisticated awareness of the cultural norms of indicating refusals beyond saying the word ‘No’. Secondly, children achieve unnoticeablity, by which they absent themselves from the ‘on-task’ classroom culture, and by extension, the research process. Thirdly, they engage in playful dissent demonstrating their political knowingness of the classroom social order. The paper discusses the implications for educational research when the values of consent are in conflict with a schooling focused on conformity. This includes emphasising the limits of consent procedures, paying closer attention to how researchers recognise and respond ethically to children’s multiple practices of dissent, and using research to disrupt problematic power structures in education settings that limit possibilities for children’s consent.