The Oak Life Journal
Jan | Feb 2023
By Aarin Talbot
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4 minute read
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Understanding what health and wellness is within orphan care requires a balanced approach, where the concept is divided into four equal parts: spirit, mind, body and emotions. However, to fully understand these categories also requires an appreciation for the surrounding legal regulations and ethical standards. These guidelines ensure that the pathway to health is safe and effective for all types of vulnerable populations, including children in alternative care.
For example, research for behavioral or biomedical breakthroughs involves a prior discussion around the issue of consent. This essential act of autonomy was established as a result of the second World War, where men, women, and children were used for heinous clinical procedures against their will under Hitler. In 1990, an international conference convened to institute a set of guidelines for the assurance of individual consent and other ethical practices during research with humans.
Examining this through the lens of a potential study in orphan care, because consent is expected, the children do not become a mere tool for research. They would not be considered lower individuals, where someone with an agenda could force the children to take part in an HIV vaccine or behavioral study without approval. That is why this practice is considered a vital ethical measure.
In children, however, consent is referred to as “assent,” because their level of comprehension has not yet fully developed to reach true consent. Parents are then asked to give their full, legal consent for the child to participate in a clinical trial. Once a child offers their assent, and the parent completes that with their consent, then the procedure or medication is approved for use.
But this process is complicated when the parents are not available to offer consent. Without them, it is simply another hindrance to autonomy and justice for children in an already long list of challenges. According to Kipnis (2003), all children are at risk for coercion and misuse in trails for several reasons, including but not limited to: 1.) Their developmental level often means an inability to make advanced decisions. 2.) They are subject to the authority of adults. 3.) They might hide their dissent for the approval of others. 4.) Their desires and rights may be socially overlooked.
It then begs the question, what measures are used to ensure the safety of children during research? Especially those children that have been placed in alternative care settings?
The answer to each question begins with the overall measure of limiting biomedical and behavioral trials to only those that will benefit these vulnerable children specifically. If a less vulnerable population is capable of handling the burden of research, or if the research does not provide solutions for their distinct problems, then the risks do not justify the benefits.
A suitable advocate can then be chosen for each child to ensure that the process of assent and consent are performed. In addition to providing their own consent, this advocate should try to remove social pressure from the child so that assent is given without coercion. According to Federal Regulations in the United States, an advocate is described as “An individual who has the background and experience to act in, and agrees to act in, the best interest of the child for the duration of the child’s participation in the clinical investigation.”
Moreover, education of child advocates, orphanage directors, and children participating in the study is critical. In clinical research, a more common term to use is informed consent, because it is hard to make a decision on something unknown. A good list of things to understand may include: purpose of the study, possible risks, possible benefits, what would be expected of the children, how to withdraw from the study if needed, who to call for questions during the course of the study, and if there are any alternatives already available. Although this is not an exhaustive list, it may serve as a good place to start for asking the right questions.
In conclusion, directors of orphanages should feel empowered to voice a child’s needs over research investigations. When consent, child advocates, and education are set in place, directors stand in the gap that’s often left by careless and preoccupied governmental agencies.
References:
Kelley et. al (2016) Ethical challenges in research with orphans and vulnerable children: a qualitative study of researcher experiences, 8(3), p. 187-96 https://academic.oup.com/inthealth/article/8/3/187/2458893
Thompson, R. T. et. al (2015) The Vulnerabilities of Orphaned Children Participating in Research: A Critical Review and Factors for Consideration for Participation in Biomedical and Behavioral Research, J Empir Res Hum Res Ethics, 7(4), p. 56-66. https://journals.sagepub.com/doi/10.1525/jer.2012.7.4.56
FDA (2001) 21 CFR Part 50 Subpart D: Additional Safeguards for Children in Clinical Investigations, p. 1 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50#subpart-D
1 thought on “The Issue of Consent in Alternative Care Research”
I think the general day to day care of a child can be viewed equivalent of a parent and child. Donig what is viewed best .
Minor medications , a trip to the doctor. What happens in the case where the parents believe in a local healer, and you disagree, desiring for a more qualified approach.