The significance of Virtue Theory in supporting Research Tissue Donation and Banking

1. The significance of Virtue Theory in supporting Research Tissue Donation and Banking Conor Brophy Chairperson, Human Research Ethics Committee Royal Brisbane & Women’s Hospital & Senior Lecturer, University of Queensland No other affiliations/interests

2. Contentions • Current research ethics principles and biobank guidance do not address all issues around banking tissue and data and biobank research. • Potential donors and communities have views which are not represented well in, and differ from those which dominate, current guidance. • The theory of Virtue Ethics provides a moral basis, and language, for addressing issues and thereby supporting biobanking and future studies.

3. Research Ethics • Five principles: • research is a good • if • research merit and integrity are sufficient • recruitment is fair & burden is balanced by benefit • benefit justifies harms which should be mitigated • participants varied interests are respected, particularly autonomy. • Respect for the individual may be over-ridden by benefit for collective others.

4. Research Ethics • Considered in context of a single research study • Tissue banking is a prelude to multiple studies spread over time, topics and communities. • Studies using banked samples and data are reviewed for research merit and integrity from the perspective of the broad community or target population. • Research merit & benefit are expected to be realised in the future. • Justice cannot be judged as future implications unknown.

5. Research Ethics • ‘Gifting’ and ‘de-identification’ are thought legitimately to disassociate sample and data from the donor, and limit risk. • Respect for autonomy over the long-term is considered to be addressed in capacity for sample withdrawal. • Respect for donor autonomy is limited as previously-obtained consent is either blanket or, if more specific, relative to understanding at the time of collection. • Consent processes cannot account for donor’s views on research in the context prevailing when samples and data used. • Is autonomy respected if donors are unaware of future proposals and results?

6. Research Ethics • Ethical review of sample and data collection is directed to research merit and integrity of initial researchers and the general purpose of the biobank. • Initial researchers and biobanks pass the baton of future compliance with the “ethically defensible plan”1 presented in the original review to multiple others. • Governance of samples and banks is subject to varied guidance and legislation in multiple countries, particularly around consent.2 • The focus of governance guidance is on effective storage and use of samples, and management of collected and research data to protect privacy. 1.National Statement on Ethical Conduct in Human Research NHMRC 2007;Sn3.5.1. 2. Biobanks Information Paper NHMRC 2010

7. Contention 1 Current research ethics principles and biobank guidance do not address all issues around banking tissue and data and biobank research. • Utilitarian-guided consideration of biobanking serves to devalue respect for the range of donor interests. • These interests extend beyond initial consent to the type of research that actually will be done, the context of the research, the nature of benefits, and who will benefit. • These issues are rarely accommodated at the time future studies are themselves reviewed.

8. Community Views • Studies3-7 give a range of motivations for potential and actual tissue donors agreeing to banking and future research. • Altruism is not the sole or primary motivator3-8. • Others are reciprocity3,4, social exchange5, revalorization of body rubbish4, and expectation of benefit for self or others3,6,7,8. • Concerns e.g. stigmatization and appropriate community benefit, may have a negative impact on tissue banking3,7. • Donation has a moral value which should be acknowledged9. 3. Hoeyer, K. Biotech & Gen Eng Rev 2008;25:429-452. 4. Morell, B. et al Qualitative Health Research 2011;21:75-84. 5. Axler, R. et al Pathobiology 2008;75:323–329. 6. Busby, H. Clinical Ethics 2010;5:22–27. 7. Ma, Y. et al 2012 PLoS ONE 7(4):e36050. 8. Soto, C. et al Arch Dis Child 2012;97:632-636. 9. Tomlinson, T. Hastings Center Report 2013;43(1):41-47.

9. Community Views • Important considerations for potential donors are trust in the individual approaching them about banking3,8, and that the institution will undertake worthwhile research, promote their interests, and return benefit3,5,6,7,8. • There is no consensus amongst researchers or the public around the type of consent, broad or specific, that should apply10 • Appropriate consultation and consent processes vary with context, circumstance, people and time11,12. 3-9 Ibid. 10. Master, Z. et al Nature Methods 2012;9(9):885-888. 11. Michalek, A & Wicher, C. J CancEdu 2011;26:212-214. 12. Mello, M. & Wolf, L. N Engl J Med 2010; 363(3):204-207.

10. Contention 2 Potential donors and communities have views which are not represented well in, and differ from those which dominate, current guidance.

11. Theory of Virtue Ethics • Emphasises character and virtues.13 • What should be done is what a virtuous person would do in the particular circumstance. • Have advantages over rule-based and consequentialist theories because • what should be done is often not clear. • relationships play an important part in deliberation • motivations for action are recognised as significant. • context can be accommodated in decisions • rules can also be incorporated. 13. Oakley, J. in A Companion to Bioethics 2009.

12. Theory of Virtue Ethics • Successful biobanking and future research is dependent on the expression of virtuous motivations and characteristics. • Donors: generosity, social engagement, benevolence, trust3-8. • Clinicians/researchers seeking samples: empathy, patience, honesty3,5,6,7,8. • Staff of Biobanks: integrity, respect, professionalism7. • Future researchers: respect, beneficence, reciprocity, integrity3,5,6,7,8,11,12. 3. Hoeyer, K. Biotech & Gen Eng Rev 2008;25:429-452. 4. Morell, B. et al Qualitative Health Research 2011;21:75-84. 5. Axler, R. et al Pathobiology 2008;75:323–329. 6. Busby, H. Clinical Ethics 2010;5:22–27. 7. Ma, Y. et al 2012 PLoS ONE 7(4):e36050. 8. Soto, C. et al Arch Dis Child 2012;97:632-636. 9. Tomlinson, T. Hastings Center Report 2013;43(1):41-47. 11. Michalek, A & Wicher, C. J CancEdu 2011;26:212-214. 12. Mello, M. & Wolf, L. N Engl J Med 2010; 363(3):204-207.

13. Theory of Virtue ethics • Studies show the perception by donors of virtuous character traits in researchers influence the likelihood of tissue donation. • Donors perceptions highlight that mutual relationships, trust, probity and respect for social contracts are important.

14. Theory of Virtue Ethics • Commentary and guidance on biobank governance2 • indicates lack of concordance in international guidance and legislation approaches to consent and use. • identifies complex interacting ethical considerations. • makes some, but limited, reference to character, acknowledging the importance of this for both donor and community interests. • National Statement “is ... oriented to something more fundamental than ethical ‘do’s’and ‘don’ts’ – namely, an ethos that should permeate the way those engaged in human research approach all that they do”.14 2 Biobanks Information Paper NHMRC 2010 14.National Statement on Ethical Conduct in Human Research NHMRC 2007;Preamble:3

15. Contention 3 The theory of Virtue Ethics provides a moral basis, and language, for addressing issues and thereby supporting biobanking and future studies.

16. Thank you