{"id":3817,"date":"2017-01-20T12:26:21","date_gmt":"2017-01-20T12:26:21","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/JE_Biobanking_CPT_6_Dec_12-Ecuru.pdf"},"modified":"2017-01-20T12:26:21","modified_gmt":"2017-01-20T12:26:21","slug":"je_biobanking_cpt_6_dec_12-ecuru-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/fr\/je_biobanking_cpt_6_dec_12-ecuru-2\/","title":{"rendered":"JE_Biobanking_CPT_6_Dec_12-Ecuru"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

JE_Biobanking_CPT_6_Dec_12-Ecuru<\/a><\/p>\n

Biobanks with particular emphasis on
\nhuman research material
\nJulius Ecuru
\nAssistant Executive Secretary
\nUganda National Council for Science and Technology
\nPresented at the
\nExpert Conference on the Revision of the Declaration of Helsinki,
\nhosted by SA Medical Association from 5-7 December 2012 in
\nCape Town, South Africa
\nj.ecuru@uncst.go.ug
\nOutline
\n\u2022 Introduction
\n\u2022 DoH provisions on human material
\n\u2022 Key biobank issues
\n\u2022 Key biobank issues for developing countries:
\nUganda as example
\n\u2022 Conclusions
\nIntroduction
\n\u2022 Advances in molecular science
\nincreasingly provide remarkable
\ncapabilities of working with
\nhuman materials (HM) — blood,
\ntissue, saliva, hair, etc — to
\nunderstand disease, & find novel
\npreventive and therapeutic
\nremedies;
\n\u2022 What we can\u2019t do today may be
\npossible to do in future.
\nIntroduction\u2026
\n\u2022 Thus, HM are stored for possible uses in future
\nresearch (i.e. biobanked).
\n\u2022 As it helps to:
\n\u2022 Preserve valuable biological information;
\n\u2022 Save time and resources;
\n\u2022 Less burdensome to sample sources;
\n\u2022 HM are exchanged across the world in thousands;
\nmany from less developed to developed countries.
\nDeclaration of Helsinki (DoH) on HM
\n\u2022 The DoH intention to provide guidance on HM is
\nclear in para A.1 of the current version,
\n\u2013 \u201cThe WMA has developed the DoH as a statement of
\nethical principles for medical research involving human
\nsubjects, including research on identifiable human material
\nand data.\u201d
\nDoH on HM\u2026
\n\u2022 But the guidance is limited to consent only as stated
\nin para B.25,
\n\u2022 \u201cFor medical research using identifiable human material
\nor data, physicians must normally seek consent for the
\ncollection, analysis, storage and\/or reuse.\u201d
\n\u2022 And in situations where consent would be impossible
\nor impractical to obtain, research may proceed with
\napproval of a research ethics committee.
\nKey biobank issues
\n\u2022 Working with HM involves dealing with a
\nnumber of complex issues, most of which are not
\nsufficiently provided for in current international
\nresearch ethics guidelines;
\n\u2022 and it appears no single ethics guidelines (e.g.
\nDoH or CIOMS,) may be able to
\ncomprehensively address biobank issues.
\nKey biobank issues\u2026
\n\u2022 There\u2019s need to articulate the issues, but have
\nan integrated mechanism to address them:
\n\u2013 Scientific concerns
\n\u2013 Collection, transportation & storage to ensure quality and sustain
\nviability of samples over long periods of time;
\n\u2013 Ethical issues
\n\u2013 Demonstrate respect for persons by ensuring proper consent,
\nprivacy & confidentiality; addressing risks, avoiding harm, and
\nensuring responsible use of HM;
\n\u2013 Socio-economic considerations
\n\u2013 Provide for fair and equitable sharing of benefits arising from
\nutilization of HM.
\nKey biobank issues for developing
\ncountries: Uganda as example
\n\u2022 Concerns over continuous shipping of HM for storage
\nabroad;
\n\u2013 Reasons for shipping:
\n\u2013 Inadequate in-country\/local scientific capacity;
\n\u2013 Weak infrastructure: labs, power cuts, safety & QC measures;
\n\u2013 Quality assurance at Central lab\u2014 especially in multicentre studies;
\n\u2013 Ugandan citizens studying abroad carry HM with them for their
\nexperiments;
\n\u2013 Cheaper to work with HM in more advanced facilities with more
\nexperienced personnel abroad;
\n\u2022 Fear of losing control over HM and data:
\n\u2013 Common questions people seek answers for:
\n\u2022 Where are the HM\/data being stored?
\n\u2022 Who owns them?
\n\u2022 How are the HM being used, for what purpose and by whom?
\n\u2022 How do we benefit from results or products developed?
\n\u2022 Will our research partners ever need to come back for research now that
\nthey have the HM?
\nKey biobank issues for developing
\ncountries: Uganda as example\u2026
\nKey biobank issues for developing
\ncountries: Uganda as example\u2026
\n\u2022 Thus the debate:
\n\u2013 Prevent shipment of HM\/data for biobanking abroad, and
\nin stead build local biobanks?
\nOr
\n\u2013 Allow shipment of HM\/data abroad but under certain terms
\nand conditions clearly stipulated in guidelines, policies, and
\nagreements?
\nKey biobank issues for developing
\ncountries: Uganda as example\u2026
\n\u2022 Lessons:
\n\u2013 Addressing issues of ownership;
\n\u2013 Employed a trusteeship model, i.e. where the providing
\norganization holds HM in trust on behalf of research
\nparticipants; but a bit complicated for private
\norganizations\/biobanks.
\n\u2013 Benefit sharing
\n\u2013 Involving the provider organization in negotiating transfer
\n& storage; use of material transfer agreements or contracts
\nhave so far been useful; ideally should include provisions
\nfor longer term collaborative partnerships for research.
\nKey biobank issues for developing
\ncountries: Uganda as example\u2026
\n\u2022 Lessons\u2026
\n\u2013 Rights of HM sources
\n\u2022 A separate consent process for HM storage, where
\nparticipant has the option to allow or refuse storage;
\n\u2022 Research participants having a right to withdraw samples,
\nif linked;
\n\u2013 Role of the Research Ethics Committees (RECs)
\n\u2022 RECs to review future studies on stored HM\u2014may help
\nin monitoring use & promoting a culture of responsibility;
\n\u2022 Approve use of HM collected outside research setting;
\nConclusions
\n\u2022 As consensus builds on some of the key biobank issues
\ndiscussed above, as always new ones will arise.
\nContinued dialogue is necessary.
\n\u2022 No current research ethics guidelines will singly address
\nall biobank issues; probably a separate more inclusive and
\noperational guidance document for biobanking in human
\nresearch activities may be needed especially for research
\nin countries with less developed human research
\nprotection systems.
\nConclusions\u2026
\n\u2022 The next DoH version may, however, broaden
\nits scope of guidance on HM & data to take
\ninto account other ethical and associated socio-
\neconomic considerations involving biobank
\nactivities.
\nSome reading material
\n1. Budimir, D., Pola\u0161ek, O., Maru\u0161i\u0107, A., Kol\u010di\u0107, I., Zemunik, T., Boraska, V., Jeron\u010di\u0107, A., et al. (2011). Ethical
\naspects of human biobanks: a systematic review. Croatian Medical Journal, 52(3), 262\u2013279.
\ndoi:10.3325\/cmj.2011.52.262
\n2. Emerson, C. I., Singer, P. a, & Upshur, R. E. G. (2011). Access and use of human tissues from the developing
\nworld: ethical challenges and a way forward using a tissue trust. BMC medical ethics, 12(1), 2. doi:10.1186\/1472-
\n6939-12-2
\n3. Hansson, M. G. (2011). The Need to Downregulate: A Minimal Ethical Framework for Biobank Research in
\nMethods in Biobanking. (J. Dillner, Ed.) (pp. 39\u201359). Humana Press, Springer Science+Business Media, LLC.
\ndoi:10.1007\/978-1-59745-423-0_2
\n4. Harris, J. R., Burton, P., Knoppers, B. M., Lindpaintner, K., Bledsoe, M., Brookes, A. J., Budin-Lj\u00f8sne, I., et al.
\n(2012). Toward a roadmap in global biobanking for health. European journal of human genetics\u202f: EJHG, 20(11),
\n1105\u201311. doi:10.1038\/ejhg.2012.96
\n5. Hewitt, R., & Hainaut, P. (2011). Biobanking in a fast moving world: an international perspective. Journal of the
\nNational Cancer Institute. Monographs, 2011(42), 50\u20131. doi:10.1093\/jncimonographs\/lgr005
\n6. Igbe, M. a, & Adebamowo, C. a. (2012). Qualitative study of knowledge and attitudes to biobanking among lay
\npersons in Nigeria. BMC medical ethics, 13(1), 27. doi:10.1186\/1472-6939-13-27
\n7. Kiehntopf, M. & Krawczak, M. (2011). Biobanking and international interoperability: samples. Human Genetics:
\n2011, 130: 369-376, Spinger
\n8. Kumar Patra, P., & Sleeboom-Faulkner, M. (2012). Informed consent and benefit sharing in genetic research and
\nbiobanking in India, 33, 237\u2013256.
\n9. Nietfeld, J. J., Sugarman, J., & Litton, J. (2011). Author version The Bio-PIN\u202f: A concept to improve biobanking,
\n308, 303\u2013308.
\n10. Rudan, I., Maru\u0161ic, A., & Campbell, H. (2011). Developing biobanks in developing countries, 1(1), 2\u20134.
\n11. Vaught, J. & Lockhart, N.C. (2012). The evolution of biobanking best practices. Clinica Chimica Acta, 413(2012)
\n1569-1575. Elservier.<\/p>\n"},"caption":{"rendered":"

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 \u2022 Introduction \u2022 DoH provisions […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{},"post":null,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/JE_Biobanking_CPT_6_Dec_12-Ecuru.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media\/3817"}],"collection":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/comments?post=3817"}]}}