From consent to institutions: Designing adaptive governance for genomic biobanks
Highlights
► Many biobanks are not able to meet traditional informed consent requirements or guarantee privacy protection. ► A loosening of informed consent and privacy requirements should be matched by an increased emphasis on good governance. ► This paper suggests four principles that should be taken into account in constructing biobanks governance. ► Concrete implementation of the principles is illustrated using the example of a particular biobank, the BC Generations Project.
Introduction
In spite of much that has been written on the topic, existing ethical conventions remain inadequate to guide the collection and storage of samples and information held in biobanks (Caulfield et al., 2008, McGuire and Burke, 2008). Existing protections, such as review by research ethics committees, anonymization, and upfront consent, may fail to protect important participant interests, impede the operation of biobanks, and ultimately limit their societal value (Cambon-Thomsen, 2004). We currently have several failures: we cannot promise privacy, nor can we offer a meaningful consent process (Cambon-Thomsen et al., 2007, Ohm, 2009, Swede et al., 2007).
With regard to privacy, current regulations focussed on the protection of the individual can undermine the scientific value of biobanks as donor anonymity forecloses longitudinal data collection. Studies focussing on the relationship between genotype and environmental factors necessarily entail a higher risk of privacy infringement (Asslaber and Zatloukal, 2007, Oosterhuis et al., 2003). Moreover, DNA is, by its very nature, a unique identifier of individuals (Bjorn, 2008, Homer et al., 2008, Lowrance and Collins, 2007). The inadequacy of current privacy protections will only increase with advances in genomics and bioinformatics and increasing linkages with health databases around the world (Riegman, Morente, Betsou, de Blasio, & Geary, 2008).
On the issue of informed consent, individuals’ consent to participate in biobanks cannot be fully informed because the very nature of biobanks is to collect samples for future research uses that may not yet be formulated (Hansson, Dillner, Bartram, Carlson, & Helgesson, 2006). Strict adherence to bioethical protocols would thus require that research participants be re-consented for every individual use of their tissue sample or personal data, a process which has been argued to be prohibitive owing to financial and logistical reasons in many circumstances. While proposals to address this problem vary, one common point of agreement is that traditional informed consent requirements need to be loosened for recruiting research participants in biobanks. Lunshof, Chadwick, Vorhaus, and Church (2008), for instance, propose an ‘open consent’ model whereby research participants consent to the unrestricted use and disclosure of their health and genetic information, and where researchers make no promises of anonymity, privacy, or confidentiality. They argue that veracity (“telling the truth”) should be the guiding principle in biobanking, preceding autonomy (Lunshof et al., 2008, p. 409).
However, there are problems with proposed measures to broaden traditional informed consent requirements (Hofmann, Solbakk, & Holm, 2009). Veracity is an obvious value that should prevail in any kind of human research but, as the corner stone of ethics in biobanking, it accomplishes too little. Without additional measures, open consent neither ensures congruence between donors’ values and the use of their samples, nor does it provide accountability to donors. Other commentators thus stress the need for a more fine-tuned approach to meeting the expectations of participants. In a tiered consent approach, for instance, participants could be offered a menu of options pertaining to future research uses, request to re-consent, interest in returning results, or data sharing options (McGuire and Beskow, 2010, Mello and Wolf, 2010). The extent to which participants understand these options, or the researchers are able to uphold the promises made by diverse participant selections (both from a financial and data management perspective), remains to be seen (Lemke et al., 2010, Ormond et al., 2009).
While these are stimulating proposals to explore, we argue that fine-tuning consent is unlikely to resolve the ethical conundrums surrounding biobanking. Rather, more robust promise lies in institutional arrangements and qualities that can adapt to changing needs and circumstances in ways that are acceptable to multiple stakeholders. Indeed, there has been increasing attention to identifying solutions to the ethical, legal, and social challenges posed by biobanks on a level of governance (Kaye & Stranger, 2009). However, little scholarly literature has explored the common theoretical foundations upon which such governance mechanisms should rest. Our purpose in this paper is to provide a starting point for this debate. We propose a series of four normative principles that might form a foundation for the development of governance structures for particular biobanks. We ground our discussion of governance by considering how these principles might be operationalized in a particular example of a Canadian longitudinal cohort study: the British Columbia (BC) Generations Project.
Section snippets
Principles of biobank governance
Several recent contributions raise alternative conceptions of participant involvement in biobanking (Ludman et al., 2010, Solbakk et al., 2009, Trinidad et al., 2011). Significantly, Caulfield et al. (2008) state that the key to resolving the ethical problems inherent in biobanking lies in appropriate governance. But what should such governance look like? What should the guiding principles be, and how should they be incorporated into institutional structures? Here, we propose four ideas (or
Enacting the principles of adaptive governance: institutional structures and mechanisms
While the development of accepted principles underlying sustainable governance of biobanks is important, equally important is the design of specific mechanisms that allow their enactment in practice. Given our discussion of the final principle of fit, it is evident that stipulating one particular model of governance for all types of biobanks is neither feasible nor desirable. Nevertheless, it is important to bring a level of specificity to this discussion. The aim of this section is therefore
Adaptive governance
The institutional structures and mechanisms outlined above are intended to satisfy the four principles of biobanking governance described previously. In brief, the structural incorporation of participant interests into governance in the form of the participant bodies would constitute formal recognition of the collective status of participants (first principle). Second, by holding management accountable through existing mechanisms such as research ethics boards (institutional review boards), a
Conclusion
We have constructed a set of normative arguments beginning with the observation that biobanks constitute an attempt to structure a research resource or platform with the objective of multiple and sometimes population based benefits. This is different from recruiting to an individual research project in which reasonable risk is assessed against a single research objective and the analysis then described for participants’ informed consent. The unspecified nature of research that could be based on
Acknowledgements
We gratefully acknowledge funding from the BC Cancer Agency that supported this research. We would also like to thank three anonymous reviewers and the members of the “Making Connections” group for valuable discussion and feedback on the ideas presented in this paper.
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