Ethical Consideration When Involving Children in Healthcare Research in the US

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Table of Contents

What Makes it an Ethical Issue
Case Examples
Conclusion
References

Healthcare research involving children is a moral duty based on various ethical principles. First, based on distributive justice, such forms of researchers are needed to ensure that children get high-quality healthcare services like all other individuals in society. Second, based on the principle of beneficence, children should receive evidence-based care. Similarly, the principle of non-maleficence holds that children should not be exposed to harmful therapies due to the lack of evidence or failure to extrapolate research findings from adult studies. Therefore, encouraging research involving children hinges on these principles and it would lead to improved healthcare.

However, the process of conducting research with children as subjects comes with different ethical challenges. Research works should take place under certain principles that should be observed all the time to protect the participants from being harmed in any way. For instance, the principle of respect requires individuals without decision-making capacity, either morally or legally, to get protection from the responsible parties. Children cannot make legally-binding decisions because they are minors, and thus they cannot give informed consent, which forms the backbone of any healthcare research. This paper addresses the various ethical challenges when involving children in healthcare research in the US by using various real-case examples that have been decided in courts.

What Makes it an Ethical Issue

Research works involving human beings of study are subject to certain moral, legal, and ethical principles. Specifically, study participants should give informed consent to voluntarily take part in the research. However, children, as minors, do not have the legal standing or the necessary mental competence to make such decisions. As such, children might not be in a position to understand comprehensively the various aspects of a given study to point out any underlying harms. The ethical challenges associated with having children subjects in healthcare research are based on the following principles.

Informed Consent

As aforementioned, children do not have the capacity, legally or morally, to make informed choices, and thus they cannot give informed consent in research. According to Manti and Licari (2018), informed consent is the process by which “a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate” (145). Based on this assertion, children cannot understand all aspects of the study, and thus even if they gave consent, it would not be based on comprehensive knowledge of the underlying issues. Consequently, such consent could not be termed as “informed.”

In other words, children lack the relevant autonomy and capacity to make informed decisions. Autonomy is the individual’s “independence in making ethical decisions and acting on them, whereas capacity is the ability to understand the information provided and the possible consequences of a decision, such as deciding whether to participate in a research study” (Kelly and MacKay-Lyons 2010, 340). Within the context of these definitions, children lack the relevant knowledge to exercise autonomy that underlies informed consent. The lack of capacity to give informed consent forms the basis of all other ethical challenges associated with involving minors in a research study. Researchers thus require the consent of an adult, either a parent or guardian, before enlisting children in any form of study.

Assent and Indications of Rejection

Information presented to participants in a given study should give a detailed explanation of what will happen during the study period, what the participants are required to do, and how the information gathered would be used including the results of the research (Moore, McArthur, and Noble-Car 2018). Additionally, there should be a provision for participants to withdraw from the study at any time on top of being informed about any underlying adverse consequences. These factors contribute centrally to the decision on whether to engage in the proposed study. However, to make the right decision, the participants should have the capacity to read and understand all the mentioned provisions. Therefore, given that children do not have the capacity to read and interpret such information correctly even when presented in simple language, it becomes an ethical challenge for the researcher because informed consent can only take place when the participant is fully informed.

Child Well-being and Protection

During a scientific study, a researcher could receive sensitive information that could jeopardize the well-being of the participating children. Under normal circumstances, adults could decide to withdraw from a study after careful analysis of how events are unfolding and concluding that their well-being is under threat (Biros 2018). However, in cases involving children, participants might lack the capacity to make the right judgment under such circumstances.

Researchers are thus tasked with the responsibility of assessing all the information emerging during a study to make the appropriate decisions. If the well-being of a child is threatened, the study should be suspended until such issues are addressed satisfactorily or terminated if there is no clear way of resolving the underlying problems. The major ethical challenge associated with this principle is the reliability of the researcher to use the presented information correctly and make the right decisions.

Minimizing the Risk of Harm

Ethical guidelines in research seek to minimize any possibility of exploitation by ensuring that the rights and welfare of the participants are observed. Consequently, when dealing with children, there is an overarching need to ensure their safety by protecting them from exposure to any form of harm that might arise during the process of conducting the research. However, some research works could be designed in a way that could harm children either physically or psychologically.

Children cannot make the right choices given their limited knowledge and capacity to make informed decisions. Therefore, the involved parents or guardians should be in a position to identify such problems and make the right decision (Roth-Cline and Nelson 2013). However, under some circumstances, even the guardians and parents might not have the relevant knowledge to decide what is good for the minor. Researchers are thus required to step in and guide the process, but the ethical challenge arises due to the overreliance on the researcher to make the right decisions in the interest of the children participants.

Case Examples

Despite the robust framework and guidelines on how research studies involving children should be conducted, some researchers contravene the set principles and engage in unethical conduct when dealing with children as research participants. Such occurrences have led to litigation with the involved parties seeking legal redress for the perceived ethical violations. This section provides three real-life cases that have been decided in court to provide a detailed analysis of the underlying issues, the determinations made, and personal opinion agreeing or disagreeing with the courts’ decisions.

Case 1: Grimes v. Kennedy Krieger Institute case (366 Md. 29, 782 A.2d 807)

In 1993, the Kennedy Krieger Institute (KKI) designed a study to examine the effects of various lead abatement interventions that were available for use in Baltimore. The government wanted to find an affordable way of lead abatement because the existing full abatement was disproportionately higher in comparison with the properties’ worth. As such, landlords opted to abandon unprofitable houses instead of incurring the expensive mandatory full lead paint abatement requirements. In the research, participants were placed into five groups each with 25 homes. In group one, minimal repairs and maintenance were conducted on the 25 homes.

In group two homes, there were greater levels of repairs and maintenance as compared to group one. In group three, more aggressive interventions compared to groups one and two were undertaken. Group four homes had earlier received complete lead abatement without additional repairs. Finally, homes in group five were built after the 1980s and thus they were presumed to be free of lead paint. The recruited families had to have small children living in these houses as the objective of the study was to measure the extent to which lead contaminated healthy children’s blood.

Later on, two families, Ericka Grimes and Myron Higgins sued KKI by arguing that while the institution knew about the dangers of lead in the homes, it did not inform the families by including such information in the consent form, and thus the study placed children participants at risk of having elevated lead levels in their blood. Additionally, Grimes claimed that KKI took unnecessarily long to notify the parents about the rising lead levels in their children’s blood in the course of the study. The trial court dismissed the case by arguing that KKI did not owe a legal duty of care to the children involved in the study. However, upon appeal, the Maryland Court of Appeals ruled that the plaintiffs had presented enough evidence to proceed to trial because the researchers at KKI owed legal duty of care to the participants.

Lo and O’Connell (2005) state that the ruling “harshly criticized the design of the study and the research oversight process and raised legal and ethical issues related to the exploitation of vulnerable populations, institutional review, and oversight of research, and the informed consent process” (44). The appeals court further ruled against allowing research studies that risk harm for children participants.

I agree with the decision made by the appeals court for various reasons. First, I believe that researchers owe a legal duty of care to participants. At the very minimum, researchers should take reasonable actions to protect participants from foreseeable exposure to harms. As such, the KKI researchers should have disclosed the potential harm that lead causes to children in the informed consent form and ensure that the parents read and understand such details. Additionally, when the researchers started noting the increasing levels of lead in the children’s blood, they should have promptly informed the parents as part of the duty of care.

These parents trusted the researchers to make the right decisions, but they failed, which raises a major ethical challenge when dealing with human subjects, let alone children. I believe that the parents could not have consented to allow their children to take part in this study if they had enough information concerning the underlying dangers of this non-therapeutic exercise.

Case 2: The Pfizer Trovan Study in Nigeria

In 1996, Tudun Wada, a region in Kano State in Nigeria, Africa, experienced a widespread outbreak of cerebrospinal meningitis, which mostly affected children. The national government, in collaboration with international partners, such as Medecins Sans Frontieres (MSF), started mobilizing resources to address this problem. Pfizer released a team of researchers to carry out research on its untested quinolone antibiotic – Trovan. The researchers enlisted 200 children and divided them into two (Okonta 2014). Participants in one group (the test group) received Trovan administered orally, while the other (control) was given Ceftriaxone or Chloramphenicol, as the gold standard of meningitis treatment. However, the control group received an under dosage of the recommended antibiotic as Pfizer sought to favor the results of Trovan. Ultimately, six and five children in the control and test groups died.

Various court cases against Pfizer were filed in the US, but four were dismissed on procedural grounds holding that the cases should be heard and determined in Nigeria. However, in 2009, the US Court of Appeals ruled that the victims of this case could sue the company in the US under the Alien Tort Statute. Pfizer finally agreed to settle the case out of court and paid $75 million for the settlement (Okonta 2014). During the court proceedings, it was established that Pfizer did not obtain ethical clearance from the relevant authorities before starting the study or informed consent from the participants’ parents. Additionally, the researchers deliberately gave lower dosages of Ceftriaxone and Chloramphenicol to favor its brand of antibiotic (Okonta 2014).

I agree with the court ruling that Pfizer violated the basic ethical principles that govern scientific research. The researchers flouted almost every guideline that should be observed during such cases. For instance, Pfizer did not obtain informed consent from the participants’ parents, which contravened the very basic principles of conducting research using human subjects. Additionally, the company did not seek approval from the relevant authorities. From an ethical perspective, it suffices to argue that Pfizer capitalized on poor research subjects for monetary gains. The fact that the involved participants were vulnerable children suffering from a treatable condition but eleven of them died from the company’s unethical conduct raises serious questions concerning how such groups of participants should be protected from such researchers in the future.

Case 3: Liu v. Janssen Research & Dev., LLC

According to Liu v. Janssen Research & Dev., LLC, Augustine Liu II, the son of Marion Liu, started treatment for mental illness in 2000 when he was aged 17 years before being diagnosed with schizophrenia in 2004. In 2008, his psychiatrist, Madeleine Valencerina sought approval from the FDA to test the efficacy of Risperidone – a long-acting antipsychotic drug administered through injection. Valencerina sought informed consent from Augustine to become a subject in this study.

Augustine provided all the relevant documents and signed the informed consent form. On Feb. 22, 2009, Augustine was admitted to a psychiatric facility scheduled to start the study. However, after being injected with 1 milligram of the test drug, a series of complications arose leading to his death on February 26, 2009. His mother, Marion Liu, sued Janssen Research & Development, LLC for negligence and awarded non-economic damages of $5.6 million. However, in 2018, a California appellate panel overturned this ruling.

I agree with the decision to overturn the court ruling because Valencerina observed all the requirements needed for such a study. First, she obtained approval from FDA and got informed consent from Augustine, the study participant. Additionally, the researcher undertook the duty of care during the study by ensuring the participant’s health and safety. However, I believe that the duty of care on the part of the researcher did not extend to protecting Augustine from unpredictable medical conditions, such as heart attack due to undiagnosed underlying health problems. Before being given the study drug, Augustine was thoroughly screened for potential health problems and it was established he was healthy enough to take the drug. Therefore, I believe that the researcher acted ethically in this case.

Conclusion

Healthcare research involving children is a delicate issue that should be addressed objectively. On the one hand, such kinds of studies are necessary to ensure that children continue getting the best care under the principle of distributive justice. On the other hand, study participants should give informed consent before taking part in any such research. However, children lack the requisite autonomy to make informed choices.

As such, they are likely to engage in studies without understanding the underlying risk factors associated with the study. Therefore, parents and guardians are expected to make the right decisions for minors by giving informed consent on their behalf. However, despite the stringent regulatory frameworks detailing how children should be handled, this paper has shown that researchers could easily flout the guidelines and engage in unethical practices. Therefore, policymakers should continue engaging the research community to progressively address this problem in the quest to protect children when they engage in healthcare studies.

References

Biros, Michelle. 2018. “Capacity, Vulnerability, and Informed Consent for Research.” The Journal of Law, Medicine & Ethics 46 (1): 72–78.

Kelly, Barbara, and Marilyn MacKay-Lyons. 2010. “Ethics of Involving Children in Health-Related Research: Applying a Decision-Making Framework to a Clinical Trial.” Physiotherapy Canada 62 (4): 338-346.

Liu v. Janssen Research & Dev., LLC | B266368 | Cal. Ct. App.

Lo, Bernard, and Mary E. O’Connell. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington: National Academies Press.

Manti, Sara, and Amelia Licari. 2018. “How to Obtain Informed Consent for Research.” Breathe 14 (2): 145-152.

Moore, Tim, Morag McArthur, and Debbie Noble-Carr. 2018. “More a Marathon than a Hurdle: Towards Children’s Informed Consent in a Study on Safety.” Qualitative Research 18 (1): 88–107.

Okonta, Patrick. 2014. “Ethics of Clinical Trials in Nigeria.” Nigerian Medical Journal 55 (3): 188-194.

Roth-Cline, Michelle, and Robert Nelson. 2013. “Parental Permission and Child Assent in Research on Children.” The Yale Journal of Biology and Medicine 86 (3): 291-301.

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