National Healthcare Agency Consent and Research Ethical

National Healthcare Agency

Consent and research

Ethical standards that apply to experimentation and research

According to the Society for Research in Childhood Development (SRCD), several basic principles must be followed when research is being conducted on children. The first principle states that the procedures must be non-harmful: "The investigator should use no research procedure that may harm the child either physically or psychologically. The investigator is also obligated at all times to use the least stressful research procedure whenever possible" (Ethical Standards for Research, 2012, SRCD). However, no specific definition of what constitutes 'harm' is given.

There is also the principle of informed consent: consent of the child and the parent. "Before seeking consent or assent from the child, the investigator should inform the child of all features of the research that may affect his or her willingness to participate and should answer the child's questions in terms appropriate to the child's comprehension" while "the informed consent of parents, legal guardians or those who act in loco parentis (e.g., teachers, superintendents of institutions) similarly should be obtained, preferably in writing" and parents, like children should also be informed of the full particulars of the research" (Ethical Standards for Research, 2012, SRCD). If other adults such as teachers are also subjects or participants in the study, their consent must be obtained as well.

The SRCD guidelines are not intended to be comprehensive, but rather relate to a specific sub-topic of research, namely the ethical quandaries that arise when doing research on children. Because children may not fully understand the long-term implications of the research that is being conducted upon them, there is a serious question as to whether children can ever truly, knowingly consent to be subjects of research in a meaningful fashion (particularly younger children). Parents and other adults act as guardians of the child's interests. The parents and other adults involved the research are assumed to have the knowledge and are able to give guidance to the child for the best possible course of actions.

This assumption is, of course, somewhat problematic, given that the consequences of being in a research study may stay with the child for the rest of his or her life, thanks to the parents' possible misjudgment. Even when parents are loving and want to help their children, they may not have the capacity to fully understand the implications of the research from a layperson's perspective. But there has been a great deal of criticism about the lack of research conducted on children, thus resulting in the off-label and experimental use of certain drugs and treatments only tested on adults. For example, there have been no extensive drug trials on the use of antidepressants in young children, causing many psychiatrists to prescribe such drugs for off-label use to children. According to one recent study on the use of antidepressants on children in the field; "children less than 13?years old were less likely to have had an FDA-approved indication (5-10%). Most off-label prescribing had inconclusive to no evidence supporting efficacy. The lack of evidence was especially pronounced for younger children" (Czaja & Valuck 2012).