1. Preamble

H3Africa Data and Biospecimen Access Committee
Guidelines
updated April 2020

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 theH3Africa Consortium will generate a range of biospecimen sample types, however they have beenrequired 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 informationaccompanies 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 orbiospecimen were collected and any other limitations stipulated by the submitting H3Africa
Investigators for each study.
The H3Africa DBAC’s secretariat 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.
2. Composition of the Committee
H3Africa's DBAC will be composed of 9 voting members with appropriate scientific, bioethics and dataexpertise, as well as 4 ex officio members. Since some requests to the committee will be for either data
(in the EGA) 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) adata expert, (iv) individuals knowledgeable in ethics of health research in Africa, (v) 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 H3Africa Steering Committee will consult broadly to identify appropriate
members of the H3Africa 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, theDBAC can call on external expertise for advice, and although H3Africa PIs cannot be involved in any
decisions of the DBAC, they may be consulted as appropriate.
Summary of DBAC composition:
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•
•
•
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Nine voting members in the categories shown in the table below.
Ex officio One PI
Ex officio One Independent Expert Committee member
Ex officio One representative from each of the major funders

Area of expertise

Number of Individuals

Scientist – relevant research
Biobanking expert
Data expert
Ethics expertise (genomic
studies in Africa)
Legal expertise
Patient advocate
Demographer/Epidemiologist
Total

2
1
1
2
1
1
1
9 membersa) Terms of Appointment
The Chair shall be elected by a majority vote of the DBAC members to a 3 year term which is renewableonce. The start date of the first 3 year term will be set by the DBAC.
Members will be appointed for a term of 3 years, with the possibility of serving a further three-year
term. Rotation of members will be staggered to allow for continuity of membership; at least threecommittee members should remain on the committee while others are replaced.
In considering the re-appointment of the Chair and the members, the H3Africa Steering Committee
shall take advice from the Secretariat.
b) The Secretariat
Support of the DBAC will be provided by the Wellcome Trust through AESA, NIH and the H3Africa
Coordinating Centre.
c) Accountability
The Committee is accountable to the H3Africa Steering Committee for acting within its remit andcarrying out its functions.

H3Africa Data and Biospecimen Access Committee2

3. Scope of Work
What the H3Africa DBAC will do:
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. The DBAC may request modifications to access requests before approval. If
necessary, the DBAC will delay a decision pending a request for additional information from thesubmitter.
The 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, orcommercial companies.
The H3Africa DBAC will only consider requests for access to data and/or biospecimens submitted using
the Data and Biospecimen Access Request Form.
Data
Submission of a Data Access Request (DAR) indicates that the Requesting Investigator (Requester) andhis/her institution have agreed to the terms and conditions for data use specified in the Data Access
Agreement (DAA) for the H3Africa Data Access Policy. This requires that Requesters, at a minimum,
agree to:
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Abide by the agreed upon research uses of the requested dataset,
Not seek to identify individuals within the dataset,
Not distribute the data in any form to any entity or individual other than his/her researchstaff or trainees or independent collaborating investigators listed in the DAR under"Research & Related Senior/Key Person Profile,"
Keep the data secure, andAcknowledge H3Africa as appropriate in publications and presentations.

Biospecimens
The DBAC will review new Biospecimen Access Requests (BARs) from qualified researchers submitted
through the Biospecimen Access Request (BAR) form and notify applicants of results within 30-60 daysof receipt.
The DBAC will only grant access to applicants outside the H3Africa Consortium who seek to use thesamples in collaboration with African researchers and who aim to build African research capacity andcapabilities.
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The DBAC will approve the specific terms of release based on the donor andrecipient’s study terms and the application details as contained in the Material Transfer Agreement(MTA).
The DBAC will take account of information from H3Africa Biorepositories, such as sample inventories
and drawdowns of limited and depletable collections, when considering new applications as well as
requests to extend use periods.
Donor PI information provided to the Biorepositories during shipping may be helpful when considering
requests to access sensitive collections involving vulnerable populations, limited quantities of material,
and/or local ethics or legal restrictions. However, the DBAC will consider this information in light of theneed to identify potential conflicts of interest and take steps to prevent any appearance of conflictfrom influencing access decisions.
If the DBAC contacts the PI about a request, the PI has 2 weeks to respond. No response within thistime frame will be considered a consent. If the PI changes institution or otherwise relinquishes
responsibility for the biospecimens, the DBAC secretariat must be notified within 30 days of transfer of
responsibility.
All BARs must include a plan for the disposal, return or transfer of unused biospecimens uponcompletion of the project.
The DBAC will mediate any disputes between biospecimen recipients, donating researchers, andparticipating Biorepositories, in matters related to quality control, access, appropriate use or otherissues specified in this policy.
Recipients must also agree to specific conditions, which at a minimum include:
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The disclosure of information regarding researcher background, intended use, timeline forcompletion of research, and ethics, technical, and publication aspects in the DAR or BAR
Adherence to H3Africa, institutional and ethics committees’ regulations as per the MTA, unlessa modification thereof is required, which would be evaluated on its own merit
Any remaining biospecimens cannot be used for other research unless a new request has been
submitted to the DBAC
Compliance with the rules that guide procedures for disposal of biospecimens following said
research, where applicable
Acknowledgement of the H3Africa consortium in publications arising from the acquired
biospecimens
New genomic data generated from the biospecimens should be submitted to the EGA under the
H3Africa project

Given that samples are a finite resource, all research projects seeking to use H3Africa biospecimensmust undergo scientific review at the recipient institution or other reputable organization and have aletter demonstrating institutional support. The DBAC will evaluate whether the scientific review was
adequate or additional review is necessary.
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In instances where an investigator wishes to refer to availability and use of H3Africa
biospecimen in research, prior to submission of a funding application, applicants may contact the
H3Africa Biorepository to obtain information about biospecimen availability and access procedures toinclude in their research proposals, however, this by no means guarantees approval or availability at
the time of eventual request The DBAC will only grant final approval for biospecimen release toappropriately reviewed funded applications. Applications will be judged in competition against existingand potential future applications and evaluated for the appropriateness of sample quantity versus
research proposed, in light of sample availability.
The H3Africa DBAC Secretariat will develop an annual report on the DBAC activities which will beavailable to the ethics committees involved in the original approval of H3Africa research projects uponrequest. The report will include information on approved and rejected applications.
4. Conflicts of Interest
Conflict of interest for DBAC members includes, but is not limited to:a. Collaboration on scientific publications with a Requester or a Co-Investigator listed on a data orbiospecimen access request within three years of the submission date of the Request. In cases
where the collaboration was on consortia-type publications, DBAC will critically evaluate eachcase on its own merit.
b. Supervisory relationship with a Requestor or a Co-Investigator listed on a data or biospecimen
access request
c. Being a Requester or a Co-Investigator on a data or biospecimen access request.
d. Business or financial connection to the requestor
DBAC members are expected to review data and biospecimen access requests in advance to identify
conflicts and communicate them to H3Africa Secretariat staff. DBAC members will recuse themselvesfrom discussion and voting on requests for which they are in conflict. All conflicts of interest will berecorded in the minutes.
5. Operations
Review schedulea. After submission of a DAR or BAR, H3Africa DBAC Secretariat staff will use a standardized
request review checklist (Appendix A) to determine whether applications are completeb. H3Africa DBAC Secretariat staff may ask for more information from the Requester and/or
her/his institution if necessary.
c. H3Africa DBAC Secretariat staff will post a summary of the request and completed checklist in aplace accessible to the DBAC only and ask members to review for Conflicts of Interest.
d. Once all actual and potential conflicts of interest are resolved, the full requests will be posted
for all DBAC members to review.
e. From an initial request, the H3Africa DBAC will aim to reach and communicate a decision in 3060 days depending on whether it is data, biospecimens or both.
H3Africa Data and Biospecimen Access Committee

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A quorum is defined as 5 out of 9 of the H3Africa DBAC members.
If it is anticipated that a quorum will not be present for making decisions about requests at a DBAC
meeting, the meeting will be moved to a date such that a quorum is reached.
For quorum to be formed, at least one H3Africa DBAC member or alternate with (a) experience inbioethics or human research participant issues, (b) genetics or genomics research and (c) biobanking
must be present at the meetings. The latter is only required for biospecimen requests.
Applications that have specific issues not covered by expertise on the Committee can be deferred forfurther consultation.
Decisions about Data and Biospecimen Access Requests
Evaluation criteria
Applications from qualified researchers that maximize use of biospecimens for biomedical research inaccordance with participant consent, institutional and country regulations/guidelines, and without
identification of individuals, will be further evaluated to assess:• Scientific merit of the request, including originality and innovative use of materials, valid design
and methodology capable of answering proposed research question, consideration ofalternative resources;• Institutional and researcher capacity, including researcher qualifications, adequate funding,ability to complete study within a defined time period;• Potential for research to be published, lead to patents or aid in discovery and development of
new therapies.
• Requirement to collaborate with and train African investigators for biospecimen access• For biospecimens the proposed work should not duplicate existing research or methods
Requests will be reviewed by H3Africa DBAC members who can vote via e-mail or any other approvedmeans to approve, reject, or discuss the request. Voting responses will be tracked by the Secretariat. If
a quorum of H3Africa DBAC members vote by the stated deadline and the vote to approve or reject arequest is unanimous, the request can be approved/rejected without discussion at a DBAC meetingand the requestor will be informed of the outcome. If the vote is not unanimous, the Chair will go withthe consensus vote, and if there is no consensus then the majority vote should be accepted . The DBAC
will aim to hold regular meetings in person, or via telephone or video conferencing software. If there isa disagreement that relates to an ethical matter, this should be referred to external ethics experts, andif agreement is still not reached it can be deferred to the original ethics committee(s) for the project.
Other disagreements may be addressed by the project PI or the funder or by calling on external
experts.
If an H3Africa DBAC member is not able to attend a meeting at which a request will be discussed, themember can raise issues and vote via e-mail. If the H3Africa DBAC member votes by e-mail prior to themeeting and important issues are raised at the meeting that may affect the member's vote, as judged
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by the members attending the meeting, the member who voted by e-mail will be
informed of the discussion and given the opportunity to reconsider her/his vote and communicate thisin writing to the DBAC prior to a final decision. The DBAC Chair will tally the in-meeting and e-mailvotes, and this will constitute the final decision of the DBAC on the matter.
The decision-making process will be reviewed by the H3Africa DBAC members at least once a year todetermine whether changes need to be made.
Procedures for Checking Elements for Research Use
Authentication and Terms of Access
Applicants and their institutions are checked by the DBAC Secretariat staff. To successfully submit arequest, Requesters and their institutions must agree to the terms of access specified in the Data
Access Agreement (DAA). Thus, authenticating Requesters and confirming agreement to the DAA
require no further steps by the H3Africa DBAC.
Ethics approvals
Ethics approval or a letter of exemption will be required for access to data and/or biospecimens,
depending on the scope of the research. For example, ethics approval is expected for requests of data
sets with detailed phenotypic information linked to biospecimens, whereas data alone, or biospecimen
derivatives and products such as anonymized cell lines, may be exempt from approval according tolocal policies. By agreeing to the terms of access in the DBAC, Requesters and their institutions are
certifying that any applicable National; U.S. Federal, State, and Local laws are being followed and that,
if applicable, a Requester is in compliance with local human subjects’ protections. While the H3Africa
DBAC is not responsible for reviewing the ethics approval letter, it must be provided if required. If
required, the DBAC can seek the opinion of the original ethics committee that approved sample
collection.
Single institution application
The Principal Investigator (applicant) must be a faculty member or government/private sector
equivalent employed by the requesting institution.
The Principal Investigator of the request and all collaborators listed as part of the request may
be from the same institution. If they are not, then all participating institutions must be listed on
the request form and H3Africa DBAC staff will contact the Requester to explain to her/him thatcollaborators from different institutions will have to submit separate access agreements if
access is granted.
Compliance with any data use limitations identified by the institutions that submitted the dataset(s):The DBAC members will review the research use statement provided by the Requester and information
provided by the submitting institution, to determine whether the proposed research use is consistent
H3Africa Data and Biospecimen Access Committee7with any data or biospecimen use limitations identified by the institutions that
submitted the dataset(s).
Decision feedback
Decisions on requests for access to datasets registered with the European Genome-phenome Archive(EGA) and the European Nucleotide Archive (ENA) are relayed in an automated fashion through the
EGA mechanism. Any decision by the H3Africa DBAC not to grant access will be conveyed to theRequester with feedback on the reasoning behind the determination, for instance, a brief summary of
the points considered about the proposed use and how these were not consistent with the data use
parameters for the dataset in question. All approved requests will be listed on the H3Africa website.
Reconsideration of DBAC decisions
If a Requester wishes to contest the H3Africa DBAC’s decision regarding the appropriateness of his or
her access to data and/or biospecimens, the Requester may contact the H3Africa DBAC Chair to discuss
the issues or resubmit her/his request. The H3Africa DBAC Chair may approach the H3Africa Steering
Committee for their advice in problematic cases.
DBAC Annual Reports
Annual Reports summarizing DBAC activities will be generated by the H3Africa DBAC Chair and will be
due to the H3Africa Steering Committee.
Appendix A: Request Review Checklist
The H3Africa DBAC Secretariat will review requests for data and biospecimens prior to submission to
the DBAC to ensure that all documents are present and in order. They will check the following:••

Is the H3Africa Data and Biospecimen Access request form complete, correctly filled in and is
the data access agreement completed and signed?
Review available information for any current ban on research with human subjects involving
the Requesting Investigator or his/her institution.

Specifically for Biospecimen requests:••••

Check that requester has a collaboration with African researchers.
Check inventories of limited and depletable collections, to ensure the sample requested isavailable.
Check evidence of scientific review and letter demonstrating institutional support
Ensure that PI comments regarding future use or caveats are included, if so requested.

The H3Africa DBAC Secretariat will:•

Gather information on projects and their aims for the H3Africa website
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Using a standardized request review checklist, the H3Africa Secretariat staff
will review requests to determine whether applications are complete prior to sending the request
for a full H3Africa DBAC review.
All applications will be made to the secretariat who will firstly check that the request is complete
and eligible for applying, secondly, they will manage the process of communication with theapplicants on instruction from the DBAC
The secretariat will ensure the DBAC receive all the documents required for making a decision,
including:o Completed access request formo Ethics consent information for relevant projecto Any additional conditions from relevant projecto Information on timeline of any publication embargoo Availability of biospecimens being requested
Maintain a list of applications and a spreadsheet documenting the process (with deliverable dates
for each step of the process)
Maintain a list of granted access requests on the H3Africa website
Check publications from requesters to ensure acknowledgement is provided and relevant
H3Africa publications are cited.
Develop and circulate an annual report to the ethics committees involved in the original
approval of H3Africa research projects on applications made for sample access, upon request.
This will include both approved and rejected applications.

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