2.5 Ethical issues in international biomedical research
2.5.1 Collaborative partnership
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The current section has reviewed some of the literature critiquing mandatory ethics review. This section highlighted that while the importance of ethics review and protecting human participants is acknowledged, there are several complaints regarding mandatory ethics review of research, particularly by social scientists whom continue to debate the suitability and relevance of research ethics/and or ethics review to social science research (Mamotte & Wassenaar, 2009). The next section reviews literature on the ethical issues of international biomedical research (Emanuel et al. 2004, 2008; Lavery et al., 2007). For the purposes of this present study, that is, to facilitate clear discussion of the findings (see Chapter 7), these topics will be set out below as follows:
collaborative partnership, social value, informed consent, vulnerability, scientific validity, favourable risk/benefit ratio, payment of research participants, standards of care, ancillary care, post-trial access, compensation for research-related injury, post-approval monitoring of studies and dissemination of results.
2.5 Ethical issues in international biomedical research
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developing country are allowed to determine for themselves whether proposed research sponsored by developed countries and conducted with human participants in developing
countries is relevant and responsive to the host community’s health needs (Emanuel et al., 2004;
Lavery et al., 2007). This means that, first and foremost, there should be no exploitation of the research communities in less developing countries. That is, the host country in which research could be conducted ought to autonomously determine if the proposed research is acceptable and relevant to the health problems of the community (Emanuel et al. 2004; Lavery et al., 2007). This can be achieved through establishing meaningful partnerships and engagement with the research enterprise- including communities in assessing health problems to be solved, determining the significance of proposed research, as well as the actual planning and implementation of research, and incorporating results and products emanating from research into local healthcare system (Benatar & Singer, 2010; Emanuel et al., 2004; UNAIDS/AVAC, 2011).
Furthermore, collaborative partnership involves strengthening of local research stakeholder capacity to synthesise and disseminate evidence to be used for policy making and health care.
Furthermore, the local community’s values, culture, traditions, language as well as the social context, and differences thereof, should be respected (Dickert & Sugarman, 2005). Additionally, a collaborative partnership entails the sustainable development of local capacity so that there is equal and full partnership in order to circumvent pervasive inequalities between developed and less developed countries (Benatar & Singer, 2010).
Weijer and Emanuel (2000) argue that the ethical goal of community engagement in research is to ensure the protection if research participants and communities. Other commentators have also
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argued that the main goals for community engagement are to ensure protection, respect, empowerment and partnership building (Dickert & Sugarman, 2005; Participants in the community engagement and consent workshop, Kilifi, Kenya, 2013; Tindana et al., 2007).
Dickert and Sugarman (2005) proposed four ethical goals that provide a framework which can be used by various stakeholders (researchers, sponsors, RECs, and communities) to evaluate
community engagement processes. These include “(1) enhanced protection, (2) enhanced benefits, (3) legitimacy, and (4) shared responsibility”. First, community engagement processes must be designed and carried out in order to help identify risks for individual research
participants and communities as well as to identify additional measures for ensuring the
protection and safety of research participants. Furthermore, community engagement can enhance the protection of non-participants through the identification of potential risks for community members who are not enrolled in the research project.
Community engagement, for example through community advisory boards (CABs), should help to enhance benefits to individual research participants in accord with the principle of
beneficence. In addition, community engagement can also benefit local communities from which research participants are recruited. Third, by allowing various stakeholders to express their views and concerns, community engagement may help to “confer ethical and political legitimacy” on a particular research study. However, achieving this goal may encounter a
number of unresolved complex questions such as, what counts as a community? Who counts as a representative? What level of community support is needed to legitimize a particular study?
Fourth, community engagement enables shared responsibility between researchers and the
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community. For example, CABs may play an active role in assisting investigators to recruit participants and ensure that the informed consent process is conducted in a linguistically and culturally sensitive manner (Dickert & Sugarman, 2005).
King, Kolopacket, Merritt and Lavery (2014) propose an ethical framework for community engagement which seeks to clarify what kinds of community engagement strategies contributes to the ethical quality of research. The framework is premised on the view that relationships between health researchers and community stakeholders in international health research studies are the foundation of meaningful engagement. The authors argue that it is primarily through the researcher-community stakeholder relationships that investigators are able to address three core ethical responsibilities: “1) identifying and managing non-obvious risks; 2) extending respect beyond the individual to the stakeholder community; and building legitimacy for the research project” (p. 3). In their view, King et al (2014) maintain that these three ethical goals collectively characterize a logical and comprehensive framework that elucidates the important role of
community engagement in international health research, and may perhaps serve as a useful reference for the on-going debate about how to evaluate the quality and impact of community engagement.
While the concept of community engagement has received much attention (Lavery et al., 2010;
Marsh, Kamuya, Rowa, Gikonyo & Molyneux, 2008; Nakibinge et al., 2009; Newman, 2006;
Newman & Rubincam, 2014; Newman et al., 2015; Participants, 2011; Tindana et al., 2007), there is a lack of consensus on the metrics for systematically evaluating community engagement (MacQueen et al., 2015). Furthermore, there is less empirical research on the salient aspects of
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community engagement (Marsh et al., 2008, 2010) and there are unresolved questions about what makes a meaningful community engagement (King et al., 2014; MacQueen et al., 2015).
Several authors in African countries, particularly at the Kenya Medical Research Institute- Welcome Trust Programme have conducted empirical studies on community engagement. For instance, Marsh et al. (2008) reported a case study in which they attempted to initiate community engagement in Kilifi, Kenya. They report that one of the important components of their
community engagement strategy established through a series of consultative activities was the establishment of a representative local resident network in different geographic locations commonly involved in research, to supplement existing communication channels (Marsh et al., 2008).
A recent review of community engagement strategies used in research in three African countries (Botswana, South Africa, and Zimbabwe) found that there were various strategies used such as formative research activities, traditional or community leaders support, community stakeholder partnership, community sensitisation and education, community advisory mechanisms, and community empowerment (Musesengwa & Chimbari, 2016). Another review of the community engagement for biomedical and genomic research in Africa by Tindana et al. (2015) found that there was a lack of uniformity on how the concept of community engagement is defined in literature. The authors report found that there was the concept of community engagement was sometimes used interchangeably with community based participatory research to engage the target community and actively participating in the identification and planning of relevant
research and disseminating the findings. The review found that CABs were commonly used as a community engagement strategy (Tindana et al., 2015). For genomic research, the review also
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found that there was a range of strategies for community engagement such as the use of community representatives, CABs, and direct engagement with potential research participants and their communities (Tindana et al., 2015).
Several empirical studies have been conducted to investigate the role of African CABs in
community engagement (Morin, Maiorana, Koester, Sheon & Richards, 2003; Reddy, Buchanan, Sifunda, Shamagonam & Naidoo, 2010). One qualitative study conducted in South Africa aimed at investigating the views of investigators, CAB members, research staff and RECs found that there were differences in stakeholders’ views of the roles and responsibilities of CABs (Reddy et al., 2010). Another study by Morin et al. (2003) involving 6 research sites of the HIV Prevention Trials Network (HPTN) in US, Zimbabwe, Peru and Thailand found that there were two models, i.e. the “broad community” and “population-specific” models for the involvement of CABs in representing research participants in HIV prevention trials in these settings. Furthermore, the study found that CABs believed that their role was to act like a bridge between the researchers and trial participants. Additionally, the study found that CABs actively played a meaningful role in improving HIV prevention clinical trials by assisting in protocol development, recruitment, and retention, as well as involvement in identifying and resolving ethical issues in clinical trials (Morin et al., 2003).
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