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Research has long been used in the medical profession to gain information about the diagnosis, treatment, and prevention diseases. It is necessary to perform research on children as we have now recognized that biological responses to diseases and drugs differ at different stages of development (Burns, 2003). The use of human subjects in research is the source of may legal and ethical challenges. The challenges are increased when dealing with children. Children are an especially vulnerable population and deserve special protection to prevent exposure to undue risk (Lenk, Radenbach, Dahl & Wiesemann, 2004). This essay will discuss the ethical challenges faced by all of the stakeholders involved in performing research on children and will show how difficult it is, at every level, to make a decision to enrol a child in a research study. The main ethical theories involved with performing research on children are the autonomy of the child and the parent versus the benefits to society in general.
After World War II, medical research was formally scrutinized when a team of German doctors were tried before an American military tribunal. This brought light to the fact that to date there was no international law that distinguished between legal and illegal human experimentation. In August of 1947, this tribunal responded with a document entitled “Permissible Medical Experiment” that out lined ten “Directives for Human Experimentation”, now known as the Nuremberg Code. These ten principles called for consent to be freely given with capacity, with comprehension of the risks and benefits involved and it must be free of coercion. The participant must be free to withdraw consent for the study at anytime. It was also stated that researchers must provide a favourable risk to benefit ratio and minimize harm and risk by having the presence of qualified personnel using proper research techniques. If the statement on consent is taken literally, some suggest that the Nuremberg Code effectively excludes children from participating in any research studies due to the inability of children to fully comprehend all of the risks and benefits (Burns, 2003). The Nuremberg Code does not specify any rules or suggestions about using children in research studies. This lack of regulation was discussed at the by the World Medical Association (WMA) in 1964 and the Declaration Helsinki was formed and has been revised as recently as 2004. The WMA recognized that there was a need to protect vulnerable persons and did so by stating that research on vulnerable persons can be done; provided the information can not be obtain by research on another group and the research is necessary to promote the health of the population represented (WMA, 2004). The WMA also stated that in the case of a child assent must be obtained, if the child is able, and is as important as consent from an authorized representative. The Helsinki document was the first to declare that there are two types of research on humans that must have distinction: non-therapeutic clinical research and research that is combined with professional care that may have a therapeutic benefit for the participant (Burns, 2003). This essay will concentrate on non-therapeutic research on children and will exclude stage two and three drug trials. When research does not offer and prospect of direct benefit to the child the ethical legitimacy of the research is a subject of great debate even if the parent grants consent (Stevens & Pletsch, 2002).
Studies that are intended to gain knowledge, and not have any therapeutic benefit for the participant, can be approved if there is no more than minimal risk involved (Kopelman, 2002). There is a problem when defining minimal risk: minimal risk is defined as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (Ross, 2003). This definition of minimal risk doesn't state whose daily life you should take into consideration. If the day consideration is the daily life of a healthy child then less risks can be places on a child than if it is the daily life of a child with a condition. This can be interpreted that a child who is already sick and having many venepunctures and other invasive procedures done can have additional tests done for the purpose of research and a healthy child cannot participate. This definition does not take into consideration the psychological stresses that are placed on the child. A child who has been exposed to many needles and is in great distress every time should not be asked to participate in research.
In stage one drug trials, parents may perceive them to have therapeutic benefit for the child as a course of therapy rather than considering the intervention as research. This may cloud the evaluation of the dangers, discomforts, and inconveniences that follow if their child participates (Kopelman, 2002). In this situation, the parents are lead to believe that they are acting in the child's best interest. They wish to provide treatment for their child's disorder, but their desire for treatment may be blocking out the fact that this is research and there are no guaranties of the outcomes. In many cases the therapeutic benefit is not for the child at the present time but it would be for children in years to come with the same condition (Stevens & Pletsch, 2002).
The first stakeholder to consider is the research participant himself. Throughout history research has been preformed on children and other vulnerable individuals which demonstrate the exploitation that can take place; especially if each stakeholder is not evaluated individually prior to viewing the benefits that research my provide to society in general. Children are more vulnerable to harm because of their cognitive and emotional development, legal capacity, level of autonomy and dependence on family influence (Stevens & Pletsch, 2002). One study that led to a public debate was at the Hebrew Infant Asylum in New York City. Hess, the director of the institution, and his colleagues withheld orange juice for infants at the institution until they developed scurvy. This study was intended to study the early signs of scurvy and had no potential benefit for the population as the cause and prevention of scurvy was already known (Sharav, 2003). Examples such as the one previously mentioned do not help the medical community as a whole present that research is preformed to benefit society. Hopefully since the date of this study the researchers as a whole have learned that interests of the child must be first. The autonomy of the child should be taken into consideration. Participating in a research study may cause harm to the child that can take away his autonomy later in life or right away by causing the child to become sick and rely on the medical profession to make him well again. The autonomy of the child is also taken away as the parent doesn't really know if the child would like to participate in research.
The child, for the most part, in unable to provide informed consent to participate in research. This lack of capacity itself raises complex ethical issues. The child is to have an authorized decision maker who is to make decisions based purely on the best interests of the child. This decision maker is usually the parent and is the second stakeholder to consider. The parents have a tough decision in the case of non-therapeutic research, how do you make a decision for your child for something that will not be beneficial for them? It can be argued that due to our duty of beneficence it is our basic instinct to want to help others, thus any child would feel that they should participate in research. Given this duty it should not be difficult to decide for a child as to participation in research; provided that the research project is well designed and likely to lead to important knowledge that will help persons in the same population in the future. One can also state that we have benefited by past research and to fulfill our obligation for justice it is necessary to participate in research so that future generations have the similar benefits. By applying these theories to the child it is being said that the child always has the best interests of others. We know from psychology that ethical reasoning and judgement develop slowly over time and varies between individuals, thus proxy decision makers cannot judge what obligations a child feels at specific points in development thus it is unjust to make a decision that is not in the best interest, as far as well being, for the child (Harris & Holm, 2003). As mentioned earlier it is also possible that parents who are enrolling their children who are already ill in stage one drug trials believe that by doing this they are providing therapy for their child. Another possibility is that parents are enrolling children into research studies due to the financial benefit. A correlation has been done of the socio-economic status (SES) of research participant that shows that those with a lower SES are more willing to participate in research as well as have their children participate. By doing this, the parent is no longer taking the well being of the child into consideration (Tait, Voepel-Lewis, & Malviva, 2003).