Conor Brophy
Chairperson, Human Research Ethics Committee
Royal Brisbane & Women’s Hospital
& Senior Lecturer, University of Queensland
No other affiliations/interests
1.
Current research ethics principles and biobank
guidance do not address all issues around banking
tissue and data and biobank research.
2.
Potential donors and communities have views which
are not represented well in, and differ from those
which dominate, current guidance.
3.
The theory of Virtue Ethics provides a moral basis,
and language, for addressing issues and thereby
supporting biobanking and future studies.
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Five principles:
◦ research is a good
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if
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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.
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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.
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‘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?
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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
Current research ethics principles and biobank
guidance do not address all issues around banking
tissue and data and biobank research.
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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.
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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.
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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
Canc Edu 2011;26:212-214. 12. Mello, M. & Wolf, L. N Engl J Med 2010; 363(3):204-207.
Potential donors and communities have views
which are not represented well in, and differ from
those which dominate, current guidance.
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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.
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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 Canc Edu 2011;26:212-214. 12. Mello, M. & Wolf, L. N Engl J Med
2010; 363(3):204-207.
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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.
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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.
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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
The theory of Virtue Ethics provides a moral
basis, and language, for addressing issues and
thereby supporting biobanking and future
studies.
Thank you