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 trials, their autonomy is being affected because they are not allowed to make their own decisions based on what they believe is best for them, they are often told what to do and they are not allowed to think about all of the options that they have. Nonmaleficence also applies to this ethical dilemma because even with all of the controversy surrounding pediatric clinical trials, researchers are always trying to not intentionally cause harm to the children, a lot of research goes into these trials and that is why there are different levels of risks for these trials and parents and participants need to be made aware of the risks.

The two ANA provisions that apply to this dilemma are provisions 1 and 3 (American Nurses Association, 2001). Provision 1 applies because pediatric nurses who are faced with this dilemma, need to make sure that they are keeping their professionalism and keep their own opinions and feelings out of the situation. Pediatric nurses need to make sure that they are taking care of the child and also the parents of the child, and this may mean that they need to explain to the parents or find someone who is capable of explaining to the parents what the clinical trials are and everything associated with them, this is so that they are able to make inform decisions, keeping their child and their own wellbeing in mind.

Provision 3 applies to this ethical dilemma because even though the nurse must take care of both the child and the parents of the child, if the child’s safety is ever jeopardize, the child must become the nurse’s first priority, regardless of what the parents may say or want, all nurses are responsible for the safety of all of their patients. If a nurse ever encounters a situation where a child is being forced or manipulated into being part of a clinical trial, they must speak up and take the appropriate actions to keep that child safe, not only physically but also emotionally.

Problem solving and dilemma outcome
In order for this ethical dilemma to come to a solution, the nurse and all of the parties involved would need to sit down, leave any personal feelings aside, and talk about the facts about the situation. The pros and the cons of the clinical trial need to be discussed, parents need to really think if the consequences are worth putting the child at risk, what will happen if the clinical trial causes additional health problems to the child?. Also if the child is old enough, the child’s opinions and desires need to be taken into consideration while trying to come up with a solution, we must not forget that even though they are children, they still have rights that need to be respected. I believe that in a situation like this, an ethics committee would be beneficial. A committee will be able to help parents to make an informed decision, and provide them with the necessary materials and resources to be able to do this, but the child will always be kept as the first priority. An ethics committee will make sure that what is best for the patient is done, and if that decision is not what the parents want or need, additional help will be provided to them. Conclusion

For many years, pediatric clinical research has been a topic of much discussion and argument. People believe that children should have a greater say in what happens to them and their bodies, and they should have the right to refuse to be in a clinical research, even if they are minors. When nurses are faced with this ethical dilemma, they should always remember that above anything else, they need to make sure that their patient is safe, both physically and emotionally. Pediatric clinical research, brings forth many complex questions, and sometimes the answers are not any easier to understand.

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​