a1 Department of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, The Netherlands
a2 Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute of Pharmaceutical Sciences, Utrecht University, The Netherlands
a3 Department of Medical Ethics, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, The Netherlands
a4 GGz Centraal, Ermelo, The Netherlands
a5 GGZ inGeest, Amsterdam, The Netherlands
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.
(Received November 16 2011)
(Reviewed March 04 2012)
(Revised March 31 2012)
(Accepted April 08 2012)
(Online publication May 21 2012)
c1 Address for correspondence: F. H. van der Baan, MSc, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Stratenum 6.131, P.O. Box 85500, 3508 GA Utrecht, The Netherlands. Tel.: +31 88 756 8002 Fax: +31 88 756 8099 Email: F.email@example.com
* These authors contributed equally to this work.