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Address | 37 2nd Circular Road Cantonments, Accra, Ghana

Address |Mainland Hospital, 1 Mainland Hospital Drive,
Yaba, Lagos, Nigeria
Email | secretariat@getafrica.org
Website | www.getafrica.org

11 January 2016

Key biobanking governance issues

This document is compiled from a presentation made by the Global Emerging Pathogens
Treatment Consortium to the 2nd WHO consultation on biobanking, held 6-7 August 2015 in
Freetown, Sierra Leone.

What is a biobank?
A biobank is a facility that actively engages with research projects and national initiatives:
• To plan the receipt of samples for processing and storage;
• Has capacity to add value to biological samples;
• Disseminates material as required for multiple research purposes; and
• Is on the cutting edge of analytical developments and enquiry.

A biobank is comprised of:

• Sample receipt platforms;
• Processing and QA facilities;
• Cryogenic infrastructure with back up (Freezers or Liquid Nitrogen, room temperature
storage, etc.);
• Inventory software and dispatch facilities (LIMS); and
• Added value service

Determining access to samples

In general, the following evaluation criteria should determine whether a request for a sample
should be granted:
• Scientific merit of the request, including originality and innovative use of materials, valid
design and methodology capable of answering proposed research question, consideration of
alternative resources;
• Institutional and researcher capacity, including researcher qualifications, adequate
funding, ability to complete study within a defined time period; and
• Potential for research to be published, lead to patents or aid in discovery and development
of new therapies.

In the specific context of samples from the West Africa EVD epidemic, priority might be given
to (in decreasing order of priority):
• Affected countries;
• Other Africans countries;
• Africans abroad;
• International scientists with African collaborators; and
• Emphasis on building capacity within Africa.

A Biospecimen Data Access Committee (BDAC) should be convened to determine who can
access samples.
 Biospecimen Data Access Committee
The BDAC makes decisions about how Biobank samples and information are used. It will
approve the specific terms of release and tailor any Material Transfer Agreement (MTA)
accordingly.

The BDAC membership should include senior representatives from various fields with no
conflict of interest, wherever possible form within Africa, including:
• Translational researchers;
• Genomics Scientists;
• Biobank specialists – i.e. operations;
• Human Research Ethics specialists;
• Legal experts; and
• Community representatives.

Governance documents
In adition to the BDAC, a number of other documents are needed for the effective operation of
the biobank, including:
• Consent Guidelines;
• Community and stakeholder engagement policy;
• MTA guidelines;
• Data sets to accompany biospecimen;
• Biospecimen Submission policy;
• Biospecimen Release Policy; and
• Data Release Policy.

Ethical considerations
Ethical governance must address:
• Storage of samples into posterity;
• Conversion of samples into cell lines;
• Movement of samples out of bank to unknown sites globally for secondary use;
• Data access;
• Commercialization;
• Return of results; and
• Beneficiation.

Key ethical questions to be answered include:

• Can the paradigms of Helsinki declaration keep up with changing landscape of R&D?
• What are the micro- and macro-ethical issues that must be taken into consideration?
• How can the perspectives of the community be included how can they be actively engaged
and their participation promoted? and
• What roles are there for Community Advisory Boards?

Community outreach advocacy is important. Unlike community engagement, advocacy

outreach is aimed at facilitating the vision and goals of the biobank through multiple tiers of

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 influence in the community. It is important in ensuring community and national ownership
and high level buy into the biobank project. Community outreach advocacy should include
both life sciences academics and social scientists. Top down, bottom up and combined
approaches should be considered.

Biobanking in a national, regional and international context

A biobank can include activities governed by a number of national laws, including the:
• Health Act;
• IP Act;
• National Health Ethics Committee;
• Health Council;
• Legal Department Material Transfer Agreement; and
• Data protection Act.

It will be important to communicate details of the biobank to national and continental and
international stakeholders, including:
• Communities affected by the disease;
• Africa Union/NEPAD;
• WAHO;
• WHO/UN;
• National Ministries of Health, Science and Technology;
• Tertiary Academic Institutions;
• Research institutions; and
• Local funding organisations.

Sustainability and costs

Establishing and running a biobank is expensive. The first year start-up costs for even a small
biorepository storing non-infectious material (e.g. planning to store 50, 000 biospecimens per
year) can easily cost $3 million. There will be additional costs for information systems.
Operating costs are estimated at about $1 million per year. When considering biobanking
samples that could include Category A pathogens, costs will be higher because of the need for
appropriate biosafety and biosecurity provisions, additional staff training, and collaboration
with national security infrastructure.

The sustainability of the biobank should be addressed from the outset. The biobank will need a
business model, and should draw upon the governance and legal structures or a University or
Ministry of Health. Services that can be provided by the biobank should be clearly identified,
including those for affected communities, the research world, university and biomediucal
institutes, as well as for personalized medicine. Potential clients might include: governments;
the pharmaceutical industry; research organizations; disease monitoring facilities; and
international partners. Potential revenue streams include: charges for the banking service;
charges for the provision of key demographic information; consultancy fees; the development
of franchise scalable models; and self, or private biobanking.

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