JE_Biobanking_CPT_6_Dec_12-Ecuru

Biobanks with particular emphasis on
human research material
Julius Ecuru
Assistant Executive Secretary
Uganda National Council for Science and Technology
Presented at the
Expert Conference on the Revision of the Declaration of Helsinki,
hosted by SA Medical Association from 5-7 December 2012 in
Cape Town, South Africa
j.ecuru@uncst.go.ug
Outline
• Introduction
• DoH provisions on human material
• Key biobank issues
• Key biobank issues for developing countries:
Uganda as example
• Conclusions
Introduction
• Advances in molecular science
increasingly provide remarkable
capabilities of working with
human materials (HM) — blood,
tissue, saliva, hair, etc — to
understand disease, & find novel
preventive and therapeutic
remedies;
• What we can’t do today may be
possible to do in future.
Introduction…
• Thus, HM are stored for possible uses in future
research (i.e. biobanked).
• As it helps to:
• Preserve valuable biological information;
• Save time and resources;
• Less burdensome to sample sources;
• HM are exchanged across the world in thousands;
many from less developed to developed countries.
Declaration of Helsinki (DoH) on HM
• The DoH intention to provide guidance on HM is
clear in para A.1 of the current version,
– “The WMA has developed the DoH as a statement of
ethical principles for medical research involving human
subjects, including research on identifiable human material
and data.”
DoH on HM…
• But the guidance is limited to consent only as stated
in para B.25,
• “For medical research using identifiable human material
or data, physicians must normally seek consent for the
collection, analysis, storage and/or reuse.”
• And in situations where consent would be impossible
or impractical to obtain, research may proceed with
approval of a research ethics committee.
Key biobank issues
• Working with HM involves dealing with a
number of complex issues, most of which are not
sufficiently provided for in current international
research ethics guidelines;
• and it appears no single ethics guidelines (e.g.
DoH or CIOMS,) may be able to
comprehensively address biobank issues.
Key biobank issues…
• There’s need to articulate the issues, but have
an integrated mechanism to address them:
– Scientific concerns
– Collection, transportation & storage to ensure quality and sustain
viability of samples over long periods of time;
– Ethical issues
– Demonstrate respect for persons by ensuring proper consent,
privacy & confidentiality; addressing risks, avoiding harm, and
ensuring responsible use of HM;
– Socio-economic considerations
– Provide for fair and equitable sharing of benefits arising from
utilization of HM.
Key biobank issues for developing
countries: Uganda as example
• Concerns over continuous shipping of HM for storage
abroad;
– Reasons for shipping:
– Inadequate in-country/local scientific capacity;
– Weak infrastructure: labs, power cuts, safety & QC measures;
– Quality assurance at Central lab— especially in multicentre studies;
– Ugandan citizens studying abroad carry HM with them for their
experiments;
– Cheaper to work with HM in more advanced facilities with more
experienced personnel abroad;
• Fear of losing control over HM and data:
– Common questions people seek answers for:
• Where are the HM/data being stored?
• Who owns them?
• How are the HM being used, for what purpose and by whom?
• How do we benefit from results or products developed?
• Will our research partners ever need to come back for research now that
they have the HM?
Key biobank issues for developing
countries: Uganda as example…
Key biobank issues for developing
countries: Uganda as example…
• Thus the debate:
– Prevent shipment of HM/data for biobanking abroad, and
in stead build local biobanks?
Or
– Allow shipment of HM/data abroad but under certain terms
and conditions clearly stipulated in guidelines, policies, and
agreements?
Key biobank issues for developing
countries: Uganda as example…
• Lessons:
– Addressing issues of ownership;
– Employed a trusteeship model, i.e. where the providing
organization holds HM in trust on behalf of research
participants; but a bit complicated for private
organizations/biobanks.
– Benefit sharing
– Involving the provider organization in negotiating transfer
& storage; use of material transfer agreements or contracts
have so far been useful; ideally should include provisions
for longer term collaborative partnerships for research.
Key biobank issues for developing
countries: Uganda as example…
• Lessons…
– Rights of HM sources
• A separate consent process for HM storage, where
participant has the option to allow or refuse storage;
• Research participants having a right to withdraw samples,
if linked;
– Role of the Research Ethics Committees (RECs)
• RECs to review future studies on stored HM—may help
in monitoring use & promoting a culture of responsibility;
• Approve use of HM collected outside research setting;
Conclusions
• As consensus builds on some of the key biobank issues
discussed above, as always new ones will arise.
Continued dialogue is necessary.
• No current research ethics guidelines will singly address
all biobank issues; probably a separate more inclusive and
operational guidance document for biobanking in human
research activities may be needed especially for research
in countries with less developed human research
protection systems.
Conclusions…
• The next DoH version may, however, broaden
its scope of guidance on HM & data to take
into account other ethical and associated socio-
economic considerations involving biobank
activities.
Some reading material
1. Budimir, D., Polašek, O., Marušić, A., Kolčić, I., Zemunik, T., Boraska, V., Jerončić, A., et al. (2011). Ethical
aspects of human biobanks: a systematic review. Croatian Medical Journal, 52(3), 262–279.
doi:10.3325/cmj.2011.52.262
2. Emerson, C. I., Singer, P. a, & Upshur, R. E. G. (2011). Access and use of human tissues from the developing
world: ethical challenges and a way forward using a tissue trust. BMC medical ethics, 12(1), 2. doi:10.1186/1472-
6939-12-2
3. Hansson, M. G. (2011). The Need to Downregulate: A Minimal Ethical Framework for Biobank Research in
Methods in Biobanking. (J. Dillner, Ed.) (pp. 39–59). Humana Press, Springer Science+Business Media, LLC.
doi:10.1007/978-1-59745-423-0_2
4. Harris, J. R., Burton, P., Knoppers, B. M., Lindpaintner, K., Bledsoe, M., Brookes, A. J., Budin-Ljøsne, I., et al.
(2012). Toward a roadmap in global biobanking for health. European journal of human genetics : EJHG, 20(11),
1105–11. doi:10.1038/ejhg.2012.96
5. Hewitt, R., & Hainaut, P. (2011). Biobanking in a fast moving world: an international perspective. Journal of the
National Cancer Institute. Monographs, 2011(42), 50–1. doi:10.1093/jncimonographs/lgr005
6. Igbe, M. a, & Adebamowo, C. a. (2012). Qualitative study of knowledge and attitudes to biobanking among lay
persons in Nigeria. BMC medical ethics, 13(1), 27. doi:10.1186/1472-6939-13-27
7. Kiehntopf, M. & Krawczak, M. (2011). Biobanking and international interoperability: samples. Human Genetics:
2011, 130: 369-376, Spinger
8. Kumar Patra, P., & Sleeboom-Faulkner, M. (2012). Informed consent and benefit sharing in genetic research and
biobanking in India, 33, 237–256.
9. Nietfeld, J. J., Sugarman, J., & Litton, J. (2011). Author version The Bio-PIN : A concept to improve biobanking,
308, 303–308.
10. Rudan, I., Marušic, A., & Campbell, H. (2011). Developing biobanks in developing countries, 1(1), 2–4.
11. Vaught, J. & Lockhart, N.C. (2012). The evolution of biobanking best practices. Clinica Chimica Acta, 413(2012)
1569-1575. Elservier.