"The keeping is the problem": A qualitative study of IRB-member perspectives in Botswana on the collection, use, and storage of human biological samples for research.
BACKGROUND
Concurrent with efforts to establish national and regional biorepositories in Africa is widespread endorsement of ethics committees as stewards of the interests of individual donors and their communities. To date, ethics training programs for IRB members in Botswana have focused on ethical principles and international guidelines rather than on the ethical dimensions of specific medical technologies and research methodologies. Little is known about the knowledge and concerns of current and prospective IRB members in Botswana with respect to export, reuse, storage, and benefit-sharing of biospecimens.


METHODS
This qualitative study examined perspectives of IRB members in Botswana about the collection and use of biospecimens in research. Forty-one IRB members representing five committees in Botswana participated in discussions groups in March 2013. Transcriptions of audiotapes and field notes were analyzed to identify issues of concern that might be alleviated through education and capacity-building, and areas that required ongoing discussion or additional regulatory guidance.


RESULTS
Areas of concern included lack of understanding among patients and providers about the use of biospecimens in clinical care and research; reuse of biospecimens, particularly issues of consent, ownership and decision-making; export of specimens and loss of control over reuse and potential benefits; and felt need for regulatory guidance and IRB-member training. Local belief systems about bodily integrity and strong national identity in the construct of benefits may be at odds with initiatives that involve foreign biorepositories or consider such collections to be global public goods.


CONCLUSIONS
Education is needed to strengthen IRB-member capacity to review and monitor protocols calling for the collection and use of biospecimens, guided by clear national policy on priority-setting, partnerships, review, and oversight. Engagement with local stakeholders is needed to harmonize fundamentally different ways of understanding the human body and community identity with the aims of contemporary biomedicine.
Institute for Health, Health Care Policy, and Aging Research Rutgers, The State University of New Jersey, 112 Paterson Street, New Brunswick, NJ, 08901-1293, USA. francis.barchi@rutgers.edu.
Francis
F
Barchi
Faculty of Medicine, University of Botswana, Plot 4775, Notwane Road, Gaborone, Botswana. matlhagelak@mopipi.ub.bw.
Keikantse
K
Matlhagela
Botswana-UPenn Partnership, 244G - Room 103, University of Botswana Main Campus, Gaborone, Botswana. niks3012@gmail.com.
Nicola
N
Jones
Faculty of Medicine, University of Botswana, Plot 4775, Notwane Road, Gaborone, Botswana. poloko.kebaabetswe@mopipi.ub.bw.
Poloko M
PM
Kebaabetswe
Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 3401 Market Street, Suite 320, Philadelphia, PA, 19104-3319, USA. merz@upenn.edu.
Jon F
JF
Merz
D018070:Biological Specimen Banks / Q000941:ethics*; D035843:Biomedical Research / Q000941:ethics*; D001902:Botswana; D057191:Capacity Building; D003657:Decision Making / Q000941:ethics*; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D010067:Ownership / Q000941:ethics*; D036301:Qualitative Research