Trial Testing in Children
Chamberlain College of Nursing
NR 322: Pediatric Nursing
Trial Testing in Children
Our country is one where every day, new medical treatments and medicines are being discovered and being approved to help Americans battle all of the different diseases and conditions that affect us. In order for us to be able to get access to those medications and treatments, many people agree to become part of clinical trials, they are the first to receive the treatments, this helps to understand how the body will be affected and if the medication will be effective. People who are part of these clinical trials, go through extensive medical testing, and they must be of sound mind and fully understand what the clinical trial is about and everything it implies, and they must be the ones making the decision, no one should be forcing them to do it. So what happens when the effects of medication and treatments need to be tested on children, because like adults, children suffer from many diseases and conditions that need new treatments, do children really understand what clinical trials are?, do they understand the risks of the trials?, is it acceptable for parents to make the decision of children being part of these trials since they are the adults and the ones who understand?, where is the line drawn when it comes to children being part of clinical trials?, there are so many complicated questions and sometimes the answers are just as complex. Ethical Dilemma
Pediatric clinical trials have not been heard of until 1955, when Hepatitis studies were performed at Willowbrook School in New York. This school housed hundreds of mentally challenged children, the physician of this school and his staff deliberately infected children with hepatitis, with the purpose of being able to create a vaccine that would cure the disease (Laventhal, Tarini & Lantos, 2012). To this day, these events are unacceptable and many people still wonder why this was allowed and why nothing was done to protect those children. Many people argue that unacceptable things like Willowbrook studies are still happening to our children, things like clinical trials that involve pediatric patients.
In current times, children are not getting infected with diseases in order to find curative vaccines, but they are being made part of clinical trials for studies of genetic screening, the enrollment of healthy children in studies of sibling bone marrow donation, and the use of hypothermia for neonates with asphyxia (Laventhal, Tarini & Lantos, 2012). These trial studies have become ethical dilemmas in pediatrics for various reasons, people believe that there are not strong enough regulations for these trials and also that children are not given the opportunity to make their own decisions, most of the time, because children are underage, parents are the ones who make the decision of making their children part of these studies. Current regulations for pediatric clinical trials only require the consent of one parent, unless they are high level risk trials, in which case both parents needs to give approval and the child must also assent. The issue of children given assent for high risk trials is controversial because how do we know that the children really understand the risks that are associated with the trials, do they fully understand that they could possibly get hurt and sometimes their lives can be in danger. ANA Code of Ethics
Ethical principles are principles that are in accordance with the rules or standards for right conduct or practice. The two ethical principles that apply to my ethical dilemma are respect for persons/autonomy and nonmaleficence (American Nurses Association). Respect for persons/autonomy applies to the dilemma of pediatric research trial because many times children are not given the opportunity to give their opinion on whether or not they want to be part of the...
References: American Nurses Association. (2001). Code of ethics for nurses with interpretive statements.
Retrieved from http://www.nursingworld.org/ethics/code/protected_nwcoe303.html
American Nurses Association (n.d.) Short definitions of ethical principles and theories, familiar
words, what do they mean? Retrieved from http://www.nursingworld.org/MainMenuCategories/EthicsStandards/Resources/Ethics-Definitions.pdf
Laventhal, N., Tarini, B., & Lantos, J. (2012). Ethical Issues in Neonatal and Pediatric Clinical Trials. Pediatric Clinics of North America, 59(5), 1205–1220. doi:10.1016/j.pcl.2012.07.007
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