Structuring Public Engagement for Effective Input in Policy Development on Human Tissue Biobanking

Abstract

We begin with the premise that human tissue biobanking is associated with ethical ambiguities and regulatory uncertainty, and that public engagement is at least one important element in addressing such challenges. One is then confronted with how to achieve public engagement that is both meaningful and effective. In particular, how can public engagement on the topic of biobanking be implemented so that (a) it is perceived broadly as legitimate and (b) the results of the engagement are relevant and useful to the institutional and regulatory context? In this paper we build on previous work that has addressed the former point and focus primarily on the latter. We argue that one way to increase the likelihood of results of public engagement being taken up in policy is through framing the issues that are deliberated by members of the public based in part on the practical policy questions for which input is sought. In this approach, we move discussion on the social and ethical implications of biobanking from abstract principles, to their consideration in the context of local biobanking practices. This is illustrated using a practical example involving a public engagement conducted to inform institutional policy for biobanking in British Columbia, Canada.

Citizens' perspectives on personalized medicine: a qualitative public deliberation study

“…This study also provides evidence of the public's ability to form coherent judgments and expectations about a new or future policy issue using structured, facilitated deliberative discussion that took place among a small group of citizens over several hours using recognized methods. [22][23][24][25] Although not intended to represent the views of the general population, the findings contribute novel and timely insights into the perceptions, values and concerns that a group of citizens and potential users hold toward personalized medicine. Importantly, the citizens' panel was concerned that personalized genomic tests might be used to ration care.…”

“…Collectively, these represent validated methods of deliberative processes, 21 which previous studies have shown to elicit in-depth views, emphasizing informed, values-based reasoning, with the goal of reaching common ground on complex, value-laden topics. [22][23][24][25][26] These deliberative methods are increasingly used to elicit public values on genomics policy issues. 17,24,25,27 The focus of this paper is on the panel's review and deliberations of GEP for early stage breast cancer, and the general topic of personalized medicine.…”

“…[22][23][24][25][26] These deliberative methods are increasingly used to elicit public values on genomics policy issues. 17,24,25,27 The focus of this paper is on the panel's review and deliberations of GEP for early stage breast cancer, and the general topic of personalized medicine. The panel was asked to deliberate on the ethical and societal questions raised by these technologies, based on a list of 'moral' questions developed by BjØrn Hofmann.…”

Engaging diverse populations about biospecimen donation for cancer research

“…Lastly, racial/ethnic minorities are already underrepresented in clinical trials (Chen et al 2014;Anderson 2004;Bruner et al 2006;Murthy et al 2004) that have been the principal conduits to cancer drug development, and unless these trends are reversed, health disparities will be even more magnified as treatments using personalized medicine technologies increase (Hall and Olopade 2006;Rebbeck et al 2006). To address these needs, institutions with biobank repositories have conducted deliberative engagement with participants to increase the community's knowledge of biobanking and inform institutional policies Lemke et al 2012;O'Doherty and Hawkins 2010). The findings from these studies suggest that such practices increase public support for biobanking, engender trust among participants, and translate public input into policy (O'Doherty et al 2012;Streicher et al 2011).…”

Biobanking: shifting the analogy from consent to surrogacy

“…Robust public engagement becomes akin to a surrogacy-advance directive conversation in responsible biobanking. [13][14][15] (Although some biobanks already conduct admirable community engagement processes, the surrogacy model articulates the underlying rationale that is obscured by the consent model. It is not clear why community engagement would be necessary if individual informed consent to donate were coherent.…”