1. The ethics of data sharing and biobanking in health research: proposals on guidance and policy issues
A critical review of the current governance framework on research involving human biological specimens in Malawi
Wongani Nyangulu, Randy G. Mungwira, Nginache Nampota, Osward Nyirenda, Titus Divala

2. Malawi

3. Research governance structure in Malawi
Government of Malawi
National Health Sciences Research Committee (NHSRC)
College of Medicine Research and Ethics Committee (COMREC)
National Commission for Science and Technology (NCST)

4. Malawi policies and ethical guidelines
Science and Technology (2003) Act
Anatomy Act
The national health sciences research committee general guidelines on health research (2007)
National policy measures and requirements for the improvement of health research co-ordination in Malawi (2012)
Policy requirements, procedures and guidelines for the conduct and review of human genetic research in Malawi (2012)
National regulatory requirements on human samples - “What is the national regulatory requirement and position on accessing, collection, storage and use of human biological specimen for research in Malawi?” (2014)

5. The NHSRC general guidelines on health research (2007)
Researchers should not collect specimens not required to address the study objectives
Tests on specimens should only be as in approved proposal
Specimens collected for a particular purpose should not be used for other purposes

6. Policy requirements, procedures and guidelines for the conduct and review of human genetic research in Malawi (2012)
Non permissible – specimen collection for future unspecified genetic research/analyses
Non permissible – plans, attempts or requests to obtain specimen for future research
Permitted – specimen export (exceptional circumstances); MTA required
Local affiliation or collaboration required

7. National regulatory requirements on human samples (2014)
Collection of specimens for future unspecified research not permitted
Consenting of participants for collection of specimens for future use not permitted
Specimens collected can be stored for a period of up to 5 years
Approval required for extension of period
Analysis must be done locally unless otherwise impossible
MTA required for sample exportation
Remaining specimen to be safely discarded or destroyed
No provision for proof of specimen destruction

8. Social value and justice
Ethical analysis
Autonomy
Social value and justice
Denying right to consent
Denying right to autonomous decision-making
Undermines principle of respect for persons
Discarding specimens – wastage
Use valuable resources
Failure to maximize benefit
Diminishes value of specimen to researchers and communities which provide them

9. Recommendations and ethical justification

10. Research participants should be allowed to consent to future use of stored human specimen
Respects autonomy
Satisfies principle of respect for persons

11. Develop guidelines to protect those with diminished or no decision-making capacity
Informed consent guidelines for persons with diminished capacity or decision-making available
No reference to specimen collection for future unspecified research

12. Community engagement Collaborative effort
Assess views on specimen collection for future unspecified use
Develop guidelines
Ethically, socially, culturally and politically sensitive
Acceptable

13. Public Education
Superstition shows lack of public understanding of science

14. Revise Material Transfer Agreement
Include requirement for proof of specimen destruction
Minimize risk of misuse

15. Conclusion
Comprehensive governance framework for research on stored human specimen in place
Some ethical requirements – narrow, restrictive, may hinder research
Need for clearer guiding policy
Balance – fostering, promoting research vs oversight, regulation

16. Thank You! (Zikomo)