Consent in psychiatric biobanks for pharmacogenetic research

Abstract

In psychiatric practice, pharmacogenetics has the potential to identify patients with an increased risk of unsatisfactory drug responses. Genotype-guided treatment adjustments may increase benefits and reduce harm in these patients; however, pharmacogenetic testing is not (yet) common practice and more pharmacogenetic research in psychiatric patients is warranted. An important precondition for this type of research is the establishment of biobanks. In this paper, we argue that, for the storage of samples in psychiatric biobanks, waiving of consent is not ethically justifiable since the risks cannot be considered minimal and the argument of impracticability does not apply. An opt-out consent procedure is also not justifiable, since it presumes competence while the decisional competence of psychiatric patients needs to be carefully evaluated. We state that an enhanced opt-in consent procedure is ethically necessary, i.e. a procedure that supports the patients' decision-making at the time when the patient is most competent. Nevertheless, such a procedure is not the traditional exhaustive informed consent procedure, since this is not feasible in the case of biobanking.

Use of next generation sequencing technologies in research and beyond: are participants with mental health disorders fully protected?

“…Cognition impairment is linked to the effects of medication and the length of the euthymic phase at time of patient evaluation [23,25]. Owen et al [22] and van der Baan et al [26] examined the significance of patients’ diminished cognition and how it impacted both treatment decisions [22] and the capacity to give informed consent on sample biobanking for pharmacogenetic studies in psychiatric wards [26]. Decisions on treatment are an imperative in most clinical settings.…”

“…In many instances, this requirement may possibly be extended to an imminent decision to participate in pharmacogenetic studies when evaluation of drug response relies on genes and gene expression analyses that need baseline sampling or a potential treatment modification decision. The latter may coincide with the need to obtain consent for sample banking procedures [26]. In which case patients experiencing a highly diminished capacity to consent [26] could be asked to understand and decide on the implications of current genetic research technology.…”

“…The latter may coincide with the need to obtain consent for sample banking procedures [26]. In which case patients experiencing a highly diminished capacity to consent [26] could be asked to understand and decide on the implications of current genetic research technology.…”

“…Distinct protective measures should be put in place for any consent process involving NGS technologies and BD, as well as analogous ailments, because of patients’ and participants’ cognitive variability: measures such as educational activities [26,27], the presence of specially-trained personnel [26], and an increased availability of genetic counselling when explaining the purpose of the study and/or the return of genetic results. The extended use of genetic counselling, as reviewed by Bunnik et al [28], is justified by “The potentially greater psychological impact of genetic testing for psychiatric diseases…” when compared to somatic conditions [28].…”

“…As discussed by van der Baan et al [26], appropriate consent forms should be based on opt-in systems so as to safeguard individual autonomy and maintain the integrity of research projects.…”