The Human Heredity and Health in Africa (H3Africa) Data and Biospecimen Access Committee (DBAC) will review and approve or reject all requests from the research community for access to biospecimens collected and data generated by the H3Africa Consortium. Data includes candidate gene association studies, genome‐wide association studies (GWAS), sequencing studies and other genotype‐phenotype studies (including sequencing and molecular diagnostic assays or phenotype data). The members of the H3Africa Consortium will generate a range of biospecimen sample types, however they have been required to deposit only DNA samples derived from their projects in the H3Africa Biorepositories. These DNA samples are accompanied by a minimum set of essential data, as the remaining information accompanies the data in the EGA which is derived from the sample. The Committee will evaluate whether the request conforms to H3Africa policies and procedures including consistency of the proposed research use with the informed consent under which the data or biospecimen were collected and any other limitations stipulated by the submitting H3Africa Investigators for each study. The H3Africa DBAC will maintain records of all researchers who have been given access to the H3Africa Consortium’s biospecimen and datasets for programmatic oversight and research purposes.

H3Africa’s DBAC will be composed of 9 voting members with appropriate scientific, bioethics and data expertise, as well as 4 ex officio members. Since some requests to the committee will be for either data or biospecimens, while others will be for both data and biospecimens, a range of expertise will be included on the committee. The committee members will include individuals who are: (i) scientists involved in research relevant to H3Africa, (ii) scientists with expertise in biobanking, (iii) a data expert, (iv) individuals knowledgeable in ethics of health research in Africa, (v) fraternity person with legal expertise and (vi) lay members (e.g. a community representative or member of advocacy groups). They should not be members of the H3Africa Consortium and should have no conflict of interest with any of the H3Africa projects. The Steering Committee will consult broadly to identify appropriate members of the DBAC. Selection of members will be done by the H3Africa Steering Committee together with Funders. The aim is that the majority of DBAC members are people residing in Africa. Four ex‐officio members who are either H3Africa project PIs, members of the Independent Expert Committee or Funders can be included in the Committee as non‐voting members. If necessary, the DBAC can call on external expertise for advice, and although H3Africa PIs cannot be involved in any decisions of the DBAC, they will be consulted as appropriate.

The H3Africa DBAC will review and approve or reject all requests from the research community (the “Research community” also includes members of commercial enterprises) for access to datasets and/or biospecimens. DBAC may request modifications to request before approval. If necessary, the DBAC will delay a decision pending a request for additional information from the submitter.

DBAC must ensure that all requests conform with H3Africa policies and procedures including compliance with the terms of informed consent and any limitations stipulated by the submitting institution/investigators for each study.

Researchers who qualify to submit a request are defined as scientists or medical professionals employed at, or legitimately affiliated with academic, non‐profit or government institutions, or commercial companies.

The H3Africa DBAC will only consider requests for access to data and/or biospecimens submitted using the Data and Biospecimen Access Request Form.

Download the H3Africa Data and Biospecimen Access Committee Guidelines here