Saving the Therapeutic Orphan: A Discussion about Pediatric Clinical Research Ethics

Performing medical research on any person requires careful ethical deliberation, but children are a particularly vulnerable group that requires additional attention and protection. Past cases of unethical research practices on children reveal the potential for tragedy. The Hepatitis experiments performed in the 1950’s at Willowbrook State School in Staten Island, NY are one example. In that instance, children (with developmental disabilities) who were living at the school were deliberately infected with hepatitis A. This experiment served as a wakeup call to the medical research community and highlighted the fact that children need additional protections if they are to be involved in research studies.

While some believe children should be completely excluded from medical research, others are open to the involvement of children as research subjects, as long as appropriate protections are in place.

First and foremost, one must consider the issue of informed consent. The Nuremberg Code, a set of ethical research principles written in response to the Nuremberg Trials, states that “the voluntary consent of the human subject is absolutely essential”. This assertion, of course, relies on the assumption that each human subject is aware and capable of understanding all potential risks and benefits of the research study in which they would be participating. Children are not necessarily capable of understanding the implications of a research study and what it would mean for them. Therefore, children are not always able to give informed consent alone. Parents and other appropriate surrogate decision makers are often included in the consent process for children.

While excluding children from research may seem like the safest and easiest way to protect them from potential risks, doing so would also unjustly deny them the potential benefits of research, and is therefore not an acceptable solution. At the same time, assumptions that research on adult populations can simply be translated to children are dangerous. Children are not ‘mini-adults’ and cannot be treated as such.

In his book, “Ethics and Research on Children: A Case-Based Approach”, Eric Koddish emphasizes the need for pediatric research and laments previous reservations about conducting such research. He states that sick children are “therapeutic orphans who have been denied access to the benefits of research.” But Koddish also understands the complexities of involving children in research. He writes, “The development for lifesaving cures for lethal childhood diseases depends on advances in pediatric research, yet child-subjects are at harm even when intentions are good.” In order to ensure that children can justly benefit from the positive aspects of medical research, precautions must be taken at all levels– through federal regulations, hospital-specific or research institute-specific policies, and clinical practice standards.

As a clinical research associate in a pediatric setting, implementing ethical standards for the children who participate in our research studies means meticulously following guidelines that ensure each family understands the potential risks and benefits of the study in which their child is an enrolled subject. This work requires training, patience, and caution but is necessary and worthwhile to ensure that families are given access to potential research benefits for their children.
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Kelly Walters is a Clinical Research Associate at Seattle Children’s in Seattle, WA, and a former intern at the Montefiore-Einstein Center for Bioethics. She graduated from Wellesley College in 2012 with a B.A. in Mathematics.


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