1. Department of Microbiology
Ethical Issues on Storage/ Sharing/Management of Biological Samples (Biorepository) and Research Data
Said Aboud
Department of Microbiology
and Immunology, MUHAS. At the Scientific Integrity Research Workshop, 08/03/2017

2. Outline of presentation
Background
Biorepository
Ethical issues on storage, sharing, management of biological samples and research data
Challenges
Conclusion

3. Background – 1
Several studies/clinical trials supported by NIH, Sida, EU, EDCTP and others have been conducted here at MUHAS
Improving lab diagnosis and monitoring of HIV
PMTCT
Tb vaccine
HIV and nutrition
HIV drug resistance
Placental malaria
Phase I/II HIV vaccine
Several papers have been published from the data collected

4. Background – 2
NIH/NICHD HPTN 046 study, 5 U01 AI , CFDA : Phase III trial to determine the efficacy and safety of an extended regimen of nevirapine in infants born to HIV-infected women to prevent vertical transmission during breastfeeding, December 2008.

5. Background – 3
EDCTP-funded TaMoVac01 study, CT_2006_33111_007: Improved DNA priming and MVA boosting strategies in healthy volunteers and HIV vaccine trial capacity building in Tanzania, 2008.
TaMoVac II Project, IP : HIV vaccine trial capacity building in Tanzania and Mozambique by continued exploration of optimal DNA priming and MVA boosting strategies, 2014.

6. Biorepository – 1
Long tradition of collecting biological samples and clinical data
Biological samples
Real time testing
Stored for later testing in another lab
Stored for future studies
Clinical/Research data
Database
Case report forms (CRFs)

7. Biorepository – 2 Biorepository space
For storage of biological samples
Biorepository personnel
Trained on organization, archiving, data entry and shipment of samples (IATA certified)
17 Thermo Forma/Electron -86 C freezers

8. Thermo Forma/Electron -86 C freezers

9. 200 KVA Back-up generator

10. Liquid nitrogen containers

11. Liquid nitrogen plant

12. IATA certified shipper

13. Biorepository – 3 Daily temperature monitoring system
Manually
Data logger
Freezer maintenance
Monthly
Six monthly and annually
Freezer repairs
Refueling of the back-up generator

14. Biorepository – 4 Biological samples 501,525
Biorepository database of specimens archived in the freezers/liquid nitrogen containers
LDMS, Lab freeze

15. Biorepository – 5 Biological samples include: Plasma Sera PBMCs
Dried blood spots (DBS)
Breast milk
Cervical vaginal lavage (CVL)
Sputum
DNA
Placental tissue

16. Biorepository – 5 Biological samples include: Plasma Sera PBMCs
Dried blood spots (DBS)
Breast milk
Cervical vaginal lavage (CVL)
Sputum
DNA
Placental tissue

17. Ethical issues on storage of biological samples
Lack of written informed consent
Lack of ethical approval from IRB
Duration of storage of biological samples
HPTN 046
For life
HIVIS03/TMV 01/TMV 02
15 years

21. Ethical issues on sharing of biological samples
Lack of signed material transfer agreement (MTA)
MUHAS
NIMR

25. Ethical issues on management of biological samples
Institutional vs. individual projects

26. Ethical issues on research data
Lack of signed data transfer agreement (DTA)

30. Challenges and the way forward
Limited financial resources
Potentials for collaborations
Utilization of archived samples for secondary analysis
PNS samples
TOV3
HIVIS03, Mal1/2
Maintenance and sustainability
PMS contracts of the freezers, liquid nitrogen plant

34. Conclusion
Storage, sharing, management of biological samples and research data poses ethical challenges, however, they have potentials for collaborations and future research in a cost-efficient manner if regulations are followed

35. Thank you for your attention!