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.