WMA-HDB-Seoul_DHAI

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Biobanks and Material Transfer Agreements:
Some Developing World Perspectives
Professor A Dhai
Director – Steve Biko Centre for Bioethics
Chairman – SAMA Human Rights, Law and Ethics Committee
WMA Expert Meeting on Health Databases and Biobanks : 01/ 2016
Human tissue
• Holds central place in history of medicine, medical research,
values, cultures, traditions
• Evokes strong but diverse emotional and spiritual responses
• Also necessary for remarkable advances on healthcare context
as major source of material for knowledge-based genomics
revolution.
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Biomedical Research
• Like the world economy – is in the era of globalization
• Increasingly being conducted in developing and emerging regions
of the world.
• Collaborations increasing – funders from better resourced regions
• Access to HBMs from research communities in developing
countries not without controversy.
Controversies
• accusations of fraud and theft
• violation of national guidelines
• cultural insensitivity
• inappropriate or lack of consent
• reluctance of international organisations to address the
concerns and recommendations of developing countries
• loss of foreign exchange due to uncontrolled export of HBMs
• inappropriate or lack of benefit-sharing
• paucity of authors from developing countries in scientific
publications from collaborations
• African scientists not seen as equal partners
• African institutions and researchers viewed as specimen
collection centres and collection technicians
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Empirical study of HBMs in collaborative research
Sathar A, Dhai A, Van De Linde S. Collaborative International Research: Ethical and Regulatory Issues
Pertaining to Human Biological Materials at a South African Institutional Research Ethics Committee.
Developing World Bioethics 2013.
Material Transfer Agreement
•Legal contract
•Governs transfer of materials between organisations
•Sets out:
–what will be done with material
–used in humans or not
–quality, terms and conditions of use
–any modifications
–third party transfers
–benefit sharing, intellectual property rights and any legal, regulatory
guidelines or policies.
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Risks of not having an MTA
•Materials may not be utilised for the agreed purpose
•Secondary uses may not be regulated
•Third party transfers may take place without the PI’s knowledge
•Donor dissatisfaction
• Biopiracy: includes theft, fraud, acquiring of exclusive monopoly control
through use of intellectual property and in particular patenting, lack of
prior informed consent from research participants.
Wits MTA Template
•Differs from traditional templates
– Includes Data
–Incorporates ethico-legal concepts
•HREC oversight
•Informed consent & secondary uses
•Benefit sharing
–Unique to developing country participants & researchers
• Benefit sharing:
– process or action of sharing in the benefits that derive from the research project
in a fair and equitable manner
– should be negotiated: sharing of information, royalties, acknowledgement of
the provider as the source of the material, publication, transferring of
technology or materials, capacity building
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Wits MTA – Signatories
1.PROVIDER (PRINCIPAL INVESTIGATOR)
2.RECIPIENT
3.HREC
MTA is subject to the suspensive condition and is of no force or
effect unless and until, the HREC has approved the study of
which the MTA forms a part of and approved the MTA.
MTA template:
http://www.wits.ac.za/academic/researchsupport/19110/ethics_
and_research_integrity.html
Co
Recommendation for Declaration
The terms of access for researchers to specimens and data
should be set out in a Material Transfer Agreement or other
agreement appropriate for that purpose
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Public Consultation
Consultation with the public and ensuring that they clearly understand the functioning of
and research conducted by the biobank : respect for communities – key
Public confidence and trust in biobanks research as being done for the common good must
be cultivated – maximize participant recruitment and retention of samples. Cultural
dynamics need to be understood
Become more knowledgeable about:
Vulnerabilities of groups, values, concerns, life experiences
Potential group harms & how to minimize harms
Potential group benefits & how to maximize them
Public Consultation
*Two thirds of respondents surveyed in Europe had not heard of
biobanks – Most respondents once aware of the concept were
generally supportive.
SA – Large scale survey not been conducted throughout country
as yet.
Meaningful conversations on biobanks between the public and
researchers are lacking.
* POST NOTE 473. Biobanks. 2014. Available from
http://researchbriefings.files.parliament.uk/documents/POST-PN-473/POSTPPN-473.PDF
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Recommendation for Declaration
Public Engagement and Trust
There must be consultation with the public to enable them to
understand their engagement in the process and to foster trust.
Ongoing dialogue between the public, researchers and biobank
managers is essential.
Intellectual Property – Current Draft
18. Special considerations should be given to the possible
exploitation of intellectual property. Protections for ownership of
materials, rights and privileges must be considered before collecting
and sharing the material.
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Recommendation for Declaration
Intellectual Property
18. Special considerations should be given to the possible
exploitation of intellectual property. Protections for ownership of
materials, rights and privileges must be considered before collecting
and sharing the material. Intellectual property rights should be
detailed in a clearly articulated policy which addresses the rights, if
any, of the database, biobank, researchers, sponsors, participants /
donors.
Recommendation for Declaration
Biobank / Database Closure
There should be a suitably detailed policy setting out the manner
in which the human biological materials and data that it holds
will be dealt with in the event of closure of the biobank or
database.
The biobank’s policy on the destruction and disposal of materials
and data should take into consideration the cultural and/or
religious beliefs of the participants / donors, and/or their
representative groups.
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Recommendation for Declaration
Lead-in to Governance :
Governance should be designed such that the rights and well-
being of participants / donors prevail over the research interests
of the data set or biobank operators and users.
Thank you