Research ethics consultation services as a strategy for dealing with return of secondary findings of genetic research

Dr Lisa Eckstein1

1 Faculty of Law, University of Tasmania, Private Bag 89, Hobart TAS 7001, lisa.eckstein@utas.edu.au

Research ethics consultation (REC) is ‘an advisory activity available throughout the lifecycle of a study’ involving ‘interaction between researchers or other stakeholders in the research enterprise and one or more individuals knowledgeable about the ethical considerations in research’.[1] The purpose of REC is to identify and analyse ethical issues, and make non-binding recommendations about a course of action.[2] Services operate independently to the regulatory review conducted by Human Research Ethics Committees (HRECs) and equivalent international bodies. Although REC services have been established in a number of United States institutions, they remain in their infancy in Australia. Ethical issues arising from emerging technologies, such as the return of secondary findings from next-generation genomic sequencing, provide an opportunity to consider an expanded role for REC in Australia.

Several features of the return of secondary genetic research findings make REC especially attractive. First, disclosure decisions implicate a broad range of ethical principles and values. Which principle or value is prioritised can lead to vastly different criteria for return. Non-binding, expert advice allows researchers to deliberate on the ethical principles most relevant to their research in the very early stages of development. This provides an informed platform from which researchers can draft the ‘ethically defensible plan (EDP)’ required for compliance with the National Statement on Ethical Conduct in Human Research.[3] Considerable time and expertise is also necessary to apply an EDP to specific secondary findings that emerge during the course of research. For example, how should we interpret criteria that results with ‘clinical value’ should be returned in the context of a sex chromosome abnormality like klinefelter syndrome? Should a determination take into account any harms of return, such as a potential non-paternity discovery should a man with children learn that his genotype is associated with infertility? These kinds of deliberations fall outside the current role and capacity of most HRECs.

This presentation will advocate for the introduction of an REC service in Australia; in particular, to deal with ethical issues raised by emerging technologies such as next-generation genetic sequencing. It will go on to canvass the potential operation of such a service and associated financial and practical costs.

[1] Laura M Beskow et al, ‘Points to Consider: The Research Ethics Consultation Service and the IRB’ (2009) 31 IRB 1.

[2] Ibid.

[3] Australian Government National Health and Medical Research Council, ‘National Statement on Ethical Conduct in Human Research’ (2007) 3.5.1.


Biography

Lisa received undergraduate degrees in law and genetics from the University of New South Wales in 2003. After receiving her Masters of Health Law from the University of Sydney, Lisa completed a Doctor of Juridical Science at Georgetown University Law Center and a post-doctoral fellowship in the Department of Bioethics at the National Institutes of Health. Lisa’s research focuses on the ethical and legal implications of genetic and other medical research. Particular interests include strategies for gaining and assessing participant consent, the disclosure of genetic research findings, clinical trial monitoring, and racially targeted biomedical research.