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

Malawi

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)

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)

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

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

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

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

Recommendations and ethical justification

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

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

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

Public Education Superstition shows lack of public understanding of science

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

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

Thank You! (Zikomo)