1. Establishment of the National Biorepository in Uganda: Some Regulatory and Ethical Uncertainties
Hellen Nansumba, Isaac Ssewanyana and Charles Kiyaga Central Public Health Laboratories

2. Over 1.1 million samples are received annually at the Centralized testing laboratory in Uganda
2/17/2019

3. National Sample and Results Transport Network (NSRTN)
100 functional HUBS
Each HUB serves a catchment area of 30-40km radius mapped around it
Serves between 20 to 30 Health facilities
Map of Uganda showing all 100 functional HUBS, reaching over 2800 health facilities
2/17/2019

4. What gap is the National Biorepository addressing?
Incorrect storage of biospecimens - leading to inaccessibility and difficult retrieval
Lack of Informed consent from patients to allow storage and utilization of biospecimens - ethical challenges
Unregulated biospecimen storage/Unmonitored Biorepositories in Uganda - Biosecurity concern
Absence of functional repository
Export of biospecimens
2/17/2019

5. Planning and development
Advocate for education in biobanking science and ethics in LMICs
Inadequate specialized biobanking science and ethics knowledge is a major cause of lack of guidelines
Regulatory bodies should generate biobanking policies and guidelines in consultation with stakeholders
REC Chairs and members
Lawmakers
Ethicists
Health Authorities
National and local policymakers
Biorepository managers
Institutional officials
Patients and Public advocates
Security organs
Resource mobilization and Infrastructure development
National Biorepository proposal and Standard Operating Procedures
Submission to Accredited RECs and Uganda National Council for Science and Technology
Approvals still pending
2/17/2019

6. Stakeholders’ consultation meeting
Research Ethics Committees
Government officers
UNCST
Ministry of Justice
Hospital Directors
University representatives and Students
Development Partners
Stakeholders’ consultation meeting
Objectives of the meeting:
How to obtain valid consent for storage and future use of samples
Role of RECs and UNCST in establishment of biobanks and biospecimen research
Networking with research institutions –promote biospecimen utilization
2/17/2019

7. Ongoing activities as resolved from the Stakeholders’ consultation meeting
Clinical and laboratory request forms should be modified to include broad consent for storage and future research use
UNCST was tasked to write biobank guidelines based on international standards
For remnant samples already in storage without consent, the National Biorepository should seek government advice through the Attorney General
UNCST was tasked to fast-track the compilation of biobank-specific policies and guidelines
2/17/2019

8. Informed consent
National guidelines for Research involving Human as Research participants state that “a specific informed consent form shall be used for samples that are collected with the intention of being stored and used for future studies” UNCST guidelines, 2011
Intended future uses of biospecimens and data are unknown at the time of diagnostic testing
Limitations
High workloads might affect effective specific informed consent
This model offers best protection for autonomy
Informed
Consent
Process
Having full knowledge and understanding
Decision to voluntarily accept/provide permission
Continuous/ongoing process
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9. Informed consent in Biobanking
‘Opt out’ principle
Should either be a regulation or a law
Obligatory information offered at Sample collection
Consent for including leftover material is presumed to be given
Can be actively withdrawn by the donor anytime
Broad consent
Obtained for unspecified future research in which case only general information regarding, or examples of, the possible future research uses is provided.
2/17/2019

10. Points for discussion
What type of informed consent is appropriate for a biobank that targets storage of remnant clinical bio-specimens
How best may we overcome the apparent obstacle of lack of prior informed consent for specimens that are already stored in the National Biorepository
Are there already models/best practices of informed consent templates for biobanking
2/17/2019

11. 2/17/2019