Background: The high disease burden of Africa, the emergence of new diseases and efforts to address the 10/90 gap have led to an unprecedented increase in health research activities in Africa. Consequently, there is an increase in the volume and complexity of protocols that ethics review committees in Africa have to review. Methods: With a grant from the Bill and Melinda Gates Foundation, the African Malaria Network Trust (AMANET) undertook a survey of 31 ethics review committees (ERCs) across sub-Saharan Africa (...) as an initial step to a comprehensive capacity-strengthening programme. The number of members per committee ranged from 3 to 21, with an average of 11. Members of 10 institutional committees were all from the institution where the committees were based, raising prima facie questions as to whether independence and objectivity could be guaranteed in the review work of such committees. Results: The majority of the committees (92%) cited scientific design of clinical trials as the area needing the most attention in terms of training, followed by determination of risks and benefits and monitoring of research. The survey showed that 38% of the ERC members did not receive any form of training. In the light of the increasing complexity and numbers of health research studies being conducted in Africa, this deficit requires immediate attention. Outcome: The survey identified areas of weakness in the operations of ERCs in Africa. Consequently, AMANET is addressing the identified needs and weaknesses through a 4-year capacity-building project. (shrink)

BackgroundConcurrent 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.MethodsThis 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.ResultsAreas 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.ConclusionEducation 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. (shrink)

There are complex unresolved ethical, legal and social issues related to the use of human tissues obtained in the course of research or diagnostic procedures and retained for further use in research. The question of intellectual property rights over commercially viable products or procedures that are derived from these samples and the suitability or otherwise of participants relinquishing their rights to the samples needs urgent attention. The complexity of these matters lies in the fact that the relationship between intellectual property (...) rights and ownership or rights pertaining to the samples on which the intellectual property right is based may either be overlooked or taken for granted. What equally makes the matter complex is that samples may be obtained from participants in developing countries and exported to developed countries for analysis and research. It is important for research ethics committees to tread carefully when reviewing research protocols that raise such issues for purposes of ensuring that appropriate benefit sharing agreements, particularly with developing countries, are in place.This paper attempts to analyse the key questions related to ownership and intellectual property rights in commercially viable products derived from human tissue samples. Patent law is used as a point of reference as opposed to other forms of intellectual property rights such as industrial designs because it is the right that most inventors apply for in respect of human tissue-related inventions. The key questions are formulated following a systematic analysis of peer reviewed journal articles that have reported original investigations into relevant issues in this field. Most of the cases and reported studies that are referred to in this paper do not directly deal with HIV/AIDS research but the underlying principles are helpful in HIV/AIDS research as well. Pertinent questions, which members of ethics review committees should focus on in this regard are discussed and suggestions on appropriate approaches to the issues are proposed in the form of specific questions that an ethics review committee should consider. Specific recommendations regarding areas for further research and action are equally proposed. (shrink)

Human Biological Materials are an invaluable resource in biomedical research. Objective To determine if researchers and a Research Ethics Committee at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Study Design Ethically approved retrospective cross-sectional descriptive audit. Results Of the 1305 protocols audited, 151 fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors were from the USA . The principle investigators in all 151 protocols informed the REC (...) of their intent to store HBMs. Only 132 protocols informed research participants . In 148 protocols informed consent was obtained from research participants, 116 protocols solicited broad consent compared to specific consent [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC than the research participants that HBMs would be exported . Export permits and Material Transfer Agreements were not available in 109 and 143 protocols, respectively. Conclusions Researchers and the REC did not adequately address the inter-related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)

Research collaboration beyond national jurisdiction is one aspect of the globalisation of health research. It has potential to complement researchers in terms of research skills, equipment and lack of adequate numbers of potential research subjects. Collaboration at an equal level of partnership though desirable, may not be practicable. Sometimes, human research specimens must be transported from one country to other. Where this occurs, there should be clear understanding between the collaborating research institutions regarding issues of access and control of the (...) specimens as well as the duration of storage of specimens. The researchers have the duty to inform the research participants about specimen storage and transport across national boundaries. While obtaining informed consent from study subjects if specimens are to be stored beyond the life of the present study could be the ideal, there still remains significant challenges in a multi-cultural world. (shrink)