International normative perspectives on the return of individual research results and incidental findings in genomic biobanks

Abstract

Managers of genomic biobanks constantly face ethical and legal challenges ranging from issues associated with the informed consent process to procedural concerns related to access by researchers. Yet, with the availability of next-generation sequencing technologies, one topic is emerging as the focus of ongoing debate: the return of individual research results and incidental findings to participants. This article examines this topic from an international perspective, where policies and guidelines discussing the matter in the context of genomic biobanks and genomic research are analyzed and commented. This approach aims to highlight the shortcomings of these international norms, mainly the danger arising from both the therapeutic misconception and the conflation of research results with incidental findings. This article suggests some elements to consider in order to complement available guidance at the international level. 2012:14(4):484-489 Genet Med

Rethinking Therapeutic Misconception in Biobanking – Ambivalence Between Research and Treatment

“…Zawati and Knoppers (2012) have suggested that international norms ought to be set up to guide the return of individual research results and incidental fi ndings based on biobank research as one way of ameliorating some of these problems arising from this misconception. We argue, however, that attempts to set up international norms and guidelines fail to address the fundamental change that is going on in medical research.…”

“…A number of recent studies have identifi ed inconsistencies between international norms and guidelines on the return of IRR and IF, and the practices associated with biobanking. The studies note that there is no international consensus on the ways in which information from biobanking research should be returned to individuals (Wolf, 2013;Zawati & Knoppers, 2012;Bledsoe et al, 2013;Forsberg et al, 2009). Many of these studies have called for international guidelines regarding the return of IRR and IF (Zawati & Knoppers, 2012).…”

“…The studies note that there is no international consensus on the ways in which information from biobanking research should be returned to individuals (Wolf, 2013;Zawati & Knoppers, 2012;Bledsoe et al, 2013;Forsberg et al, 2009). Many of these studies have called for international guidelines regarding the return of IRR and IF (Zawati & Knoppers, 2012). The ambiguities associated with whether or not information ought to be shared with research participants highlights the tenuous relationship that biobanking is producing in relation to its research population in general.…”

“…The patchwork of practices related to reporting has contributed, we would argue, to an ambiguity in which the delineation between research and clinical practice is often diffi cult to ascertain. Zawati & Knoppers (2012) have recently noted that "it is important to encourage endeavours that aim to provide a clear set of defi nitions related to the return of IRRs and IFs at the international level. " This, according to them, will allow for much needed consistency in international norms and will reduce ambiguity and contradictions. "…”

“…A number of recent commentators have noted that in biobank research participants may be guided by what is called therapeutic misconception, whereby participants attribute therapeutic intent to research procedures (Zawati & Knoppers, 2012;Forsberg et al 2009;Appelbaum et al, 1982).…”