Consent is a fundamental element of ethical research. In this case, the experiment will be carried out on children and therefore a number of challenges will arise as regards consent due to their incompetency in making decisions on their participation in the research. As a precondition to acquiring consent, an independent review of the associated potential risks and benefits will be necessary (Hickey, 2007). Following an independent review of risks and potential benefits with a positive outcome, consent of participants will be sort. Due to a lack of cognitive powers and experience that would enable a meaningful understanding of medical treatment on the part of children, parental or else guardian approval will be sort as per regulatory requirements (Spriggs, 2010). Sufficient time will be spent in preparing simple participatory resources to be utilized in the process for both the children and their parents/guardians. To ensure a full understanding of what is presented in the form and thus mitigate language barriers, readability will be increased through the use of simple yet comprehensive language (Spriggs, 2010).
Assumedly, parents may be more concerned about their children and will be expected to pose many questions. They may ask about the implications of the experiment for their children. According to Coney (2010), parents will want to know the risks that face their children due to participation. One of the underlying behaviors as has been found by various researches is that parents will tend to be protective of their children as regards participating in research (Hickey, 2007). Consequently, many questions are expected to be asked regarding the risks and benefits. Parents might also inquire about what their children will have said in the discussion held with the latter. Since the research will definitely come up with some results, parents are likely to ask if and when they may access such results. It is ethical that the results of the research be presented to the rational parent/guardian of the participating children because they are directly responsible for the welfare of their child and have the right to know the outcome on behalf of the children (Hickey, 2007).
Hickey (2007) noted that in many circumstances as this, it is ethically necessary to involve the participants (children) to some extent, even though their assent is not required. The children will thus be engaged in discussions that resonate with their level of understanding. In particular, the discussion will be driven towards obtaining their assent, which Spriggs defined as relating to positive agreement, which may come without understanding and is therefore not synonymous with consent (2007, p. 7). Despite this, the children’s objection will not hold although it will be taken into account and may help explain behavior during the experimentation period. Giving information to the children through such a discussion will have many benefits. The major benefits are that they will be in better conditions psychologically to participate in the experiment and will likely co-operate. The children’s trust in their parents and the researcher and also allows them to express their opinion as stated above (Coyne, 2010).
There arises conflict in this type of study from two stand points: on the one hand, the experiment involves risks of different probability while on the other hand, the research is expected to better the medical practices related to late-stage-leukemia. In such a scenario, the research may be carried out if the potential benefits outweigh the potential risks. Upon determining that the associated risks are reasonable relative to potential benefits, Hickey (2007) argued that the research may be carried out because in that case, it is expected to be of value. In this exercise, it is expected that on different occasions some requests might be turned down by parents and therefore substantial effort will be necessary to arrive at a desired sample size.
Coyne, I. (2010). Research with Children and Young People: The Issue of Parental (Proxy)
Consent. Children & Society, 24(3): 227-237. Retrieved from: http://onlinelibrary.wiley.com/doi/10.1111/j.1099-0860.2009.00216.x/pdf
Hickey, K. (2007). Minor’s Rights in Medical Decision Making. JONA’s Healthcare Law,
Ethics, and Regulation, 9(3): 100-104. Retrieved from: http://www.bhslr.edu/!userfiles/pdfs/course-materials/Minors%20Rights%20in%20Medical%20Decision%20Making.pdf
Spriggs, M. (2010). Understanding Consent in Research Involving Children: The Ethical Issues.
A Handbook for Human Research Ethics Committees and Researchers. The Royal Children’s Hospital in Melbourne. Retrieved from: http://www.mcri.edu.au/media/62539/handbook.pdf