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Nursing assignment 806

 Children as Research Subjects  John Lantos summarizes the views of three specific researchers regarding the subject of child involvement in clinical research and the level of consent required to participate. Lantos describes that Beecher, a well-respected researcher in the 1960’s and 70’s, was torn on the idea of experimental trials involving minors. Beecher agreed that if the trial was to benefit the patient (even if they were a minor) and had minimal risk involved, that minors should be included in the subject population “as long as informed consent is obtained from the minor’s parents or guardian” (Lantos, p. 96). It was this debate, and many more regarding the conduct of clinical research, that brought about the rules and regulations we have today guiding our experiments and studies. Beecher did not believe in the multitude of codes set forth to dictate how research was conducted, including the strict guidelines on informed consent. He believed that informed consent was never truly accurate, as there are always unforeseeable risks and “no two situations are alike”. He also believed that research should be reviewed by a panel of individuals for ethicality, but these panels should consist of the researchers themselves. Beecher believed we should be able to trust the physicians to conduct trials at the highest standard by using “their own consciences and their experiences as their guide” (Lantos, p. 97). Lantos highlights the Willowbrook State school study over hepatitis as a prime example for children involved in research. he notes that Beecher disapproved of this trial because although consent was received from the parents, it is likely that these parents did not fully understand the risks involved and if they had, the study would probably not have been conducted as the parents wouldn’t have agreed to participate. Regarding child participation, Lantos brings to light the differing opinions of two other researchers, Ramsey and McCormick. Ramsey argued that even if consent is given, children should never be the subjects of clinical research, unless that research is guaranteed to benefit the child. McCormick argues the opposite side, stating that research in minors may be required if we want to make advances in medical treatment for minors. McCormick concedes that consent must be obtained from the parent or guardian, but does not believe that research cannot be done with children at all, as that poses a risk to our advancing medical knowledge which could lead to more harm than good for children (Lantos, p 99). Beecher posits that although consent may never cover all possible risks, as there are always unknowns when it comes to experimental treatment, it still must be required to conduct research on children. However, Beecher never assumed that there would be such strict guidelines regarding what must be involved in consent and how strictly the researcher would be watched when conducting his research (Lantos, 101-102).          In another article on research involving children as subjects, Ariella Binik notes that one of the biggest ethical questions on this topic is the issue of informed consent (Binik, p. 27). Depending on the age of the minor involved in research, they may not be able to provide consent for themselves at all (i.e., aren’t able to speak yet), and if they are of talking age, most do not have the capacity to fully understand the research being explained to them within the consent form, and therefore cannot provide true consent to participating. Another problem lies in the type of research conducted, and as stated in Binik and Lantos’ articles, Ramsey argued that non-therapeutic research, or research that will not give results that directly benefit the patient, involving children is absolutely unacceptable. Binik explores the idea of “benefit arguments” when justifying children as research participants (Binik, p. 28). Benefit arguments explain that research risks are justified by the benefits they can provide to the patient. This is true when it relates to direct benefits. However, when using these arguments to justify non-therapeutic research, the proponents argue that the benefits can be broader, non-direct, and sometimes not even medical, to justify the research risks (Binik, p. 30). Do these arguments truly discredit the idea that children cannot truly consent to participating in research? could these arguments go so far as to prove that informed consent for research involving children is not required? This is a scary thought. We cannot justify research and the risks it poses by coming up with intangible and unproven possible benefits. I agree with McCormick on the subject of children in research. how can we expect to further our knowledge of pediatric diseases and treatments if we do not study the population that they effect? I also agree that consent absolutely must be obtained and all known risks must be outlined prior to completing this research. It is clearly better to make subjects and their parents fully aware of what could possibly happen (even if it is not fully inclusive) then to not give them any information at all. As stated in his article, Lantos points out that Beecher “did not conclude from this that consent should not be sought. Instead, he thought of consents as an unattainable goal toward which we should nevertheless strive” (p 103). Much of the article also discusses the fact that there are such strict regulations guiding research conduct, where instead, we could just trust physicians to run clinical trials on their own and believe that they will lead us down the best path for our health. I strongly disagree with this. Not only has history proven this theory wrong, we also cannot blindly follow our clinician’s advice and assume they know best. Although they may be more trained and educated, without regulation, they may no longer have the patient best interest at heart. To agree with everything our doctor tells us and not have the right or capacity to disagree can lead to dangerous results. Beecher argued that when receiving treatment outside of clinical research, we “trust clinicians themselves to make the decisions about what therapies are appropriate…”, but when the word research is included, a panel of third party members must decide what is appropriate and fair to the subject (Lantos, p 103-104). The biggest part of this statement that stands out to me is that he is referencing non-experimental treatment when arguing that we trust the physician. We of course trust the physician completely when they are deciding a regular course of treatment that has been proven to work. However, when the treatment is experimental, there can be no harm in having a board of peers review the research to ensure that the patient is getting the respect they deserve. The rules and codes for research and consent forms is not showing distrust in the physician or his opinions and advice, but is instead giving the patient a voice in the situation and ensuring that basic human rights are present. Binik, A. (2018). Does benefit justify research with children?. Bioethics, 32(1), 27-35. doi:10.1111/bioe.12385 LANTOS, J. (2016). HENRY K. BEECHER AND THE OVERSIGHT OF RESEARCH IN CHILDREN. Perspectives In Biology & Medicine, 59(1), 95-106.

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