An Urban Bioethics Approach to Parental Informed Consent for Pediatric Clinical Research [DISSERTATION]
Flanagan, Ellen
Cecelia Temple University, December 2018
Abstract  
In the current healthcare landscape, parents generally make decisions regarding whether or not their children are allowed to take part in clinical research, with the general assumption being that parents know what is best for children. Investigations have been conducted regarding what is likely to lead parents to consent or not consent to their child’s participation in a trial, but research plans seldom incorporate the consideration that not all parents come into the consent process with equal social, academic, and economic footing. Since the burden of the ultimate decision lies primarily on the parents, it is supremely important that they are capable of making a well-informed and thoughtful choice. Bioethical understanding of the influence of parental decisions in clinical research must consider demographic variables and how they may affect parents’ decisions to allow or disallow their child to participate in a clinical trial. Those differences could affect the consent process and have ramifications for the research findings, as research results are affected in numerous ways by which children do, and do not, participate in studies. This paper looks specifically at parents in the process of informed consent for pediatric research, taking into account several social determinants of health and how they affect who participates in research and how that affects research as a whole.

The complexities and contradictions in participatory research with vulnerable children and young people: A qualitative systematic review
Caroline Bradbury-Jones, Louise Isham, Julie Taylor
Social Science & Medicine, October 2018; 214 pp 1-214
Abstract
Participatory research carried out by or with children, has become a well-established and valuable part of the research landscape investigating children’s lives, views and needs. So too has a critical agenda about its ethical implications and methodological complexities. One criticism is that the involvement of children who may be considered ‘vulnerable’ or ‘marginalised’ has been slower to take root within mainstream participatory practice. This means that there has been less focus on how groups such as disabled children or children affected by abuse or neglect can shape and challenge adult-dominated types of knowledge and decision-making that are likely to affect them. This article reports on the findings of a qualitative systematic literature review of thirteen contemporary papers. The review was undertaken by a UK team in 2017. The included articles explored some core ethical and methodological issues involved in carrying out participatory research with vulnerable children and young people. It reports on three themes: 1) The extent to which participatory spaces could recalibrate opportunities and attention given to marginalised and silenced groups; 2) The ways in which these children and young people could develop skills and exercise political and moral agency through participatory activity, and, 3) How to facilitate meaningful engagement with individuals and groups and reconcile this with a critical appreciation of the important but limited nature of research as means of political and social change. The review provides a unique, contemporary analysis of participatory research with vulnerable children, illuminating in particular its conceptual complexities and contradictions, particularly regarding power, empowerment and voice. Its overall utility and interest is augmented by the disciplinary and geographical breadth of the included articles, rendering it relevant to many contexts and countries.

Improving the informed consent process among HIV‐infected undisclosed minors participating in a biomedical research: insights from the multicentre nutritional SNACS study in Senegal
Fabienne Hejoaka, Marie Varloteaux, Caroline Desclaux‐Sall, Sidy Mokhtar Ndiaye, Karim Diop, Aminata Diack, Fatou Niasse, Cécile Cames
Tropical Medicine & International Health, 9 January 2019
Abstract
Objectives
Providing research information in a manner accessible to minors participating in biomedical research is a major challenge. Guidance is dramatically lacking regarding best practices for seeking informed consent among undisclosed minors enrolled in HIV‐related research. We implemented an improved informed consent process (IICP) and identified factors associated with understanding of the information presented to HIV‐infected minors prior to their enrolment in a study.
Methods
We enrolled study participants attending 12 paediatric HIV clinics in Senegal. Children ≥7 years were provided with standardised research information using the IICP, which involves viewing a video and taking part in extended group discussions. Understanding was assessed by seven basic questions scored 1 or 2 points, with a maximum score of 11 points. A score of 9 or more points was defined as satisfactory understanding. Factors associated with understanding were identified using a stepwise logistic regression model.
Results
Overall, 112 children, with a median age of 12.9 years (IQR: 10.2–15.0), participated in the IICP, of whom 37% were HIV disclosed. 71% achieved a satisfactory understanding score and all gave consent to participate in the research. HIV‐disclosed children were more likely to demonstrate satisfactory understanding than undisclosed children (aOR = 3.2, 95% CI: 1.1–9.6). Age, study setting and education level were not associated with satisfactory understanding.
Conclusion
These findings provide practical guidance for the development of improved and friendly informed consent processes in research involving minors. The implementation of the paediatric HIV research agenda will require a standardised and operational definition of informed consent, integrating the issue of HIV disclosure.

Ethical complexities in child co-research
Merle Spriggs, Lynn Gillam
Research Ethics, January 2019; 15(1) pp 1–16
Abstract
Child co-research has become popular in social research involving children. This is attributed to the emphasis on children’s rights and is seen as a way to promote children’s agency and voice. It is a way of putting into practice the philosophy, common amongst childhood researchers, that children are experts on childhood. In this article, we discuss ethical complexities of involving children as co-researchers, beginning with an analysis of the literature, then drawing on data from interviews with researchers who conduct child co-research. We identify six ethical complexities, some of which are new findings which have not been mentioned before in this context. In light of these possible ethical complexities, a key finding is for researchers to be reflexive – to reflect on how the research may affect child co-researchers and participants before the research starts. A separate overriding message that came out in responses from the researchers we interviewed was the need for support and training for child co-researchers. We conclude by providing a list of questions for reflexive researchers to ask of themselves when they use child co-research methodology. We also provide important questions for human research ethics committees to ask when they review projects using child co-research.

Who Speaks for Me?: Addressing Variability in Informed Consent Practices for Minimal Risk Research Involving Foster Youth
MV Greiner, SJ Beal, A Allen, V Patel, J Meinzen-Derr, AH Matheny Antommaria
Journal of Health Disparities Research and Practice, Winter 2018; 11(4) pp 111-131
Abstract
Background
Youth in protective custody (i.e., foster care) are at higher risk for poorer physical and mental health outcomes compared with those who are not in custody. These differences may be due in part to the lack of research on the population to create evidence-based recommendations for health care delivery. A potential contributor to this lack of research is difficulties in obtaining informed consent for empirical studies in this population. The objective of this study was to describe the approaches to obtaining informed consent in minimal risk studies of foster youth and provide recommendations for future requirements.
Methods
We conducted a systematic review of the literature to characterize the informed consent approaches in published minimal risk research involving youth in foster care. We searched PubMed, CINAHL, PsychINFO, Embase, ERIC, Scopus, and EBMR. Inclusion criteria were: studies conducted in the United States, included current foster youth, minimal risk, peer reviewed, and published in English. Full text was reviewed, and individuals required to consent and assent were extracted.
Results
Forty-nine publications from 33 studies were identified. Studies required 0 to 3 individuals to consent. Individuals required to give consent included case workers (16, 48%), foster caregivers (12, 36%), biological parents (7, 21%), judges (5, 15%), and guardian ad litems (2, 6%). Twenty-nine (88%) studies required the youth’s assent. The studies used 14 different combinations of individuals. One (3%) study utilized a waiver of consent.
Conclusions
There is no consistent approach for obtaining informed consent for foster youth to participate in minimal risk research. Consent should ideally involve individuals with legal authority and knowledge of the individual youth’s interests and should not be burdensome. Consensus regarding consent requirements may facilitate research involving foster youth.