SUB-SAHARAN AFRICAN REGIONAL BIOSPECIMEN REPOSITORY (SSA RBR)
The United States National Cancer Institute (NCI) has supported the development of a Sub-Saharan African Regional Biospecimen Repository (SSA RBR) at Stellenbosch University and Tygerberg Hospital under the auspices of the AIDS Malignancy Clinical Trials Consortium (AMC) and the AIDS and Cancer Specimen Resource (ACSR). The SSA RBR constitutes a programme to support building capacity for research on HIV-associated malignancy in Africa. This initiative will contribute significantly towards promoting research based on high quality biospecimens and data sets that have been obtained with informed consent and managed according to best practices.
Biospecimens and pertinent data sets from consented HIV-positive and HIV-negative (control) donors, including participants in AMC clinical trials in Africa, will be collected, processed, and stored according to South African legal and ethics regulations. Standard operating procedures of the AMC and ACSR, representing both U.S. NCI and the International Society for Biological and Environmental Repositories (ISBER) best practices are followed.
The SSA RBR conforms and contributes to evolving policies on biobanking and biospecimen utilization in South Africa. Additionally, it promotes ethical and equitable biobanking policies for community and public education regarding biobanking and genomics for the health of African populations.
The aims of the SSA RBR include to:
- Establish a regional HIV-related malignancy biospecimen repository for Sub-Saharan Africa that will proactively obtain HIV-related malignant biospecimens and relevant data,
- Manage and process biospecimens from patients with HIV-associated malignancies enrolled in AMC clinical trials conducted in Africa,
- Offer training related to biobanking for African and other scientists, and
- Provide a community outreach portal.
The SSA RBR is located on the10th floor at the Tygerberg Academic Hospital in Parow, Cape Town and comprises approximately 50m2 laboratory space and 36m2 space for offices and storage. The facility offers 24/7 secure and controlled access, emergency electricity supply, air conditioning to ensure climate control, a recently upgraded fume extraction duct system and a biosafety level 2 hood.
The SSA RBR has the capacity and expertise to receive, process, store and dispatch whole blood specimens (plasma, PBMCs, serum); saliva (supernatant, pellet); fine needle aspirations; body fluids; paraffin embedded tissue blocks; snap frozen fresh tissue in liquid nitrogen; and specimens for PCR / molecular pathology including DNA and RNA extractions. Available cryogenic equipment includes a Thermo Scientific™Forma™ 88000 Series -86°C Upright Ultra-Low Temperature Freezers with CO2 back-up system and racks for 40000 2ml vial capacity, as well as a MVE819P-190 AF GB LN2 freezer and racks. The cryogenic equipment is under 24/7 temperature monitoring and equipped with an alarm system with 24/7 available response. A disaster plan and backup system are in place.
The SSA RBR has its own server with an Operating System and a Database Management System that have been designed and set up according to ACSR standards and with access to the AMC Global Trace System. Controlled access and data encryption are in place to ensure security and patient confidentiality. Back up servers are provided in the Faculty of Medicine and Health Sciences at Stellenbosch University, compliant with defined ACSR and SU requirements. The SSA RBR enjoys close collaboration with SU IT experts regarding continuous support.
The SSA RBR manager is a PhD scientist who enjoys support from a NHLS scientist (MSc). An assistant will be appointed soon. Training of staff include formal courses regarding IATA; SANAS (South African National Accreditation System); Best Clinical Laboratory Practices (GCLP); Bioethics; hands on training at ACSR RBR Washington DC and on site training at the SSA RBR by staff from ACSR RBR Washington. Staff joined the International Society for Biological and Environmental Repositories (ISBER) and the European, Middle Eastern and African Society for Biopreservation and Biobanking (ESBB).
The SSA RBR operates strictly according to the Standard Operating Procedures and Technical Processes of the AMC, the ACSR and the AMC Biorepository (GWU) representing both US NCI and (ISBER) best practices.
The SSA RBR will function under the auspices of the ACSR and the 2014 ACSR Manual of Operations and Bylaws and it will comply with the relevant South African safety regulations and legislation.
The SSA RBR has Institutional Review Board approval from the Health Research Ethics Committee at Stellenbosch University, as well as the Department of Health in the Western Cape Province to operate at Tygerberg Hospital. Staff members from the SSA RBR furthermore actively participate in national discussions and work groups on ethico-regulatory detail pertaining to biobanks in South Africa.
The SSA RBR promotes ethical and equitable policies for community and public education regarding biobanking to improve health of people on the African continent. The SSA RBR is in process to establish a Community Advisory Groups according to CAB Guidelines from NHREC SA (2012); AMC (revised 11 July 2014); and the recommendations for Community Engagement in HIV/AIDS Research Version 2.0 (2014).
Advantages of the SSA RBR for AMC clinical trials:
The SSA RBR serves as a hub site to receive, process, store, batch, and transport all AMC laboratory specimens from the African AMC site to core laboratories under quality controlled conditions and according to relevant AMC SOP’s.
African AMC clinical trial sites that require assistance, e.g. with collection or transportation of biospecimens, can contact the SSA RBR in their time zone, allowing specimen collection to occur in a timely manner. The SSA RBR can assure specimen integrity and that specimens are accounted for prior to the specimens being sent to core laboratories. The SSA RBR will collaborate with AMC core labs in the US through regular contact by email, Skype, and teleconference. The SSA RBR, in collaboration with Stellenbosch University authorities, can assist to obtain the required export permit(s) and Material Transfer Agreement(s) to ensure compliance with legal requirements.