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 mus
t 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.