IBRH3AU Governance Structure & Functions

With further development of the H3Africa Consortium as well as the Biorepository program it has become apparent that several management structures have already been put in place and that the objective of the biorepository within the consortium with current available funds are for DNA storage. It is thus prudent that a revised management plan is proposed. We propose to phase out the ELSI committee and replace it with the H3Africa Data and Biospecimen Access Committee. The IBAP will be replaced with NIH Biorepository program consultants. The External Oversight Committee is phased out and its functions will be taken over by the IBRH3AU Executive Committee now composed of the Senior four key personnel, coordinator, laboratory manager and administrator. We further propose to merge the risk management committee and quality assurance committee to create the QA & Risk Management Committee. The bioinformatics and data access committee is phased out as the H3Africa Data and Biospecimen Access Committee will handle its tasks while the Data (LIMS/BIMS) Management committee will be maintained.

The new management plan is summarized in the schema below

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H3Africa Consortium Governance Structures

Those directly related to the Biorepository governance and functioning include the H3Africa Biorepository program consultants. These will be utilized as follows: to ensure that IBRH3AU practices are in conformity with international standards; provide advice to the Scientific Director in terms of the strategic development; offer scientific oversight of the IBRH3AU; provide strategic and technical advice on development of new biospecimen collections and biobanking initiatives.

The H3Africa Data and Biospecimen committee: responsible for the review and approval of requests for biospecimen and review compliance with international ethical regulations.

IBRH3AU Executive Committee

Composed of the Scientific Director, all Key Personnel, Coordinator and Administrator is responsible for the coordination of the IBRH3AU activities, including managing the communication with stakeholders and collaborators, determining priority of each user application, formatting meetings, monitoring progress and communicating with user and the day-to-day running of the biorepository.

Their role is largely administrative - i.e. policies of the project were developed by this committee. This group will receive further intensive training in biorepository science and management. We shall hold continuous consultation on how to further strengthen the proposed administrative structures depending on international world class biorepository models.

The total number of core biorepository personnel has been scaled down to a staff of eight (Coordinator, Laboratory manager, Administrator, Database Officer and four technologists).

Biobank business consultant

At the start of UH3 scale up, we shall engage an international consultant with a track record in the science and management of biorepositories. The person will be responsible for developing business linkages between the biorepository and industry and research community. By marketing the utilization of IBRH3AU biorepository and expanding its scope, funds will become available towards the sustainable management of the resource.

QA & Risk management committee.

Composed of the Quality Officer, Coordinator, Lab Manager and Data Officer will be responsible for quality control/quality assurance processes as well as risk management, emergency response, and health and safety issues. The Quality and Safety Officer will lead this committee.

Data management committee

Consisting of the Data Manager, Data Officers, Quality Officer, Coordinator and Lab Manager. This committee will be led by the Database Officer and will be responsible for administration of the biorepository database (LIMS), coordinate sample entry and exit as well as monitor sample inventory

MakCHS Grants Office (Administration of Funds)

The NIH funds will be managed through the MakCHS Grants Office which is managed by three well trained and qualified personnel and will be responsible for the accountability of the funds. They have been previously trained in Grants Management by NIH staff and they do not require any further training.