The ethics of psychopharmacological research in legal minors

Abstract

Research in psychopharmacology for children and adolescents is fraught with ethical problems and tensions. This has practical consequences as it leads to a paucity of the research that is essential to support the treatment of this vulnerable group. In this article, we will discuss some of the ethical issues which are relevant to such research, and explore their implications for both research and standard care. We suggest that finding a way forward requires a willingness to acknowledge and discuss the inherent conflicts between the ethical principles involved. Furthermore, in order to facilitate more, ethically sound psychopharmacology research in children and adolescents, we suggest more ethical analysis, empirical ethics research and ethics input built into psychopharmacological research design.

Out of the Black Box: Treatment of Resistant Depression in Adolescents and the Antidepressant Controversy

“…Unfortunately, conducting clinical trials in the pediatric population has challenges. Since children are a vulnerable population, ethical issues are foremost in the conduct of treatment studies (Field and Behrman 2004;Tan and Koelch 2008). Parents should make an informed decision to consent for their children to participate in a treatment study.…”

Ethics in child and adolescent psychiatric care: An international perspective

“…Providing the best care for vulnerable populations seems a promise everyone would support. But the reality of care may be different from those promises; for example, the best evidence for the treatment strategies used is not always available for patients in child and adolescent psychiatry and not all medication approved for adults is approved for children too (Koelch, Schnoor, & Fegert, 2008;Tan & Koelch, 2008). Several authors have discussed ethics principles in child and adolescent psychiatry with respect to treatment, psychotherapeutic settings, psychopharmacotherapy and research (Belitz & Bailey, 2009;Frank, Novick, & Kupfer, 2003;Koelch et al, 2008;Koocher, 2003;Kumra, Ashtari, Anderson, 2006;Malhotra & Subodh, 2009;Nelson & Quintana, 2005;Riddle, Walkup, & Vitiello, 2008;Sondheimer, 2008;Vitiello, 2003).…”

“…The promise of provision of best evidence treatment to children is limited by the fact that evidence for the efficacy of treatments can best be obtained through research (Tan & Koelch, 2008). But research on children has to be conducted within special limits -minimal harm and burden, no involvement of children in research projects against their will, and the necessity of obtaining both the informed consent of caregivers and the assent of the child or the adolescent (Hoop, Smyth, & Roberts, 2008;Tan & Koelch, 2008).…”

“…The treating psychiatrist must navigate a path between these differing wishes and respect both the rights of the child and the need for guardianship of the child who is not a fully competent or legally competent subject. Just as in research, so too in routine care, factors such as informed consent or assent and the privacy of health care information are subject to good ethical practice requirements (Ascherman & Rubin, 2008;Koelch et al, 2008;Tan & Koelch, 2008).…”

Pediatric Psychopharmacological Research in the Post EU Regulation 1901/2006 Era

“…The major reasons for slow progress in the field prior to 2007 were twofold. First, as discussed by Tan and Kölch (2008), this research targets a doubly-vulnerable population from an ethical viewpoint, as these individuals are both (1) legal minors and (2) psychiatrically ill. Ironically, the reluctance to involve this population in research led to a situation where few pediatric clinical trials of psychotropic medication were being performed in Europe, making only scant data concerning short and longterm efficacy, tolerability, and safety available.…”