CHAPTER TWO LITERATURE REVIEW
2.3 THE DEBATE ABOUT CARE IN HIV VACCINE TRIALS
2.3.5 COMMUNITY ENGAGEMENT
There has also been debate regarding the specific role that participating communities should play in care-related issues in HIV vaccine trials (MacQueen & Sugarman, 2003) even while endorsing more broadly that engaging community in care-related issues is critical (Heise et al., 2008; MacQueen & May, 2008; Participants, 2008). Some commentators have argued that the best foundation to ground the practice of providing treatment to those who acquire HIV-infection in prevention trials lies in moral negotiation with participating communities (Weijer & LeBlanc, 2006). They asserted that the basis of moral negotiation lies in the principle of respect for communities which they interpret as taking seriously community values and respecting decisions of ‘legitimate communal authorities’ (Weijer & LeBlanc, 2006, p. 805). Weijer and LeBlanc (2006) have argued that respect for communities can be specified in a number of ways, including consulting community members to ensure the research addresses local health needs and priorities.
identify benefits that are consistent with their own health-related priorities’ and are deemed valuable, including care (Weijer & LeBlanc, 2006, p. 804/805). On their recommendation, there should be a dialogue with communities about research benefits to ensure that benefits are ‘consistent with communal health-related priorities’ (p. 807). More specifically, communities and researchers should negotiate benefits associated with trial participation, allowing differing solutions to arise for different communities (Weijer & LeBlanc, 2006). They asserted that in a community without access to basic health care for it’s members (or even clean water), ART for infected trial participants may not be a high priority and the community may prefer help to establish a clinic to address general or basic needs of community members (or even a well for clean water). However, they allowed that, in another community, access to ART for participants may be deemed the highest priority by participating communities.
Other commentators have also proposed that, in order to define treatment responsibilities in vaccine trials, researchers should engage stakeholders, including community representatives, in a structured decision-making process, to allow agreement to be reached on core obligations regarding care (Tarantola et al., 2007). This approach has been termed the ‘good governance’ approach. These authors proposed that stakeholders must consider who gets care (screen-outs? trial participants? community members?) and for what (the target disease?
other conditions identified in the trial?). However this model offers little guidance on which substantive moral rationales will carry the day in working out these difficult questions, and merely proposed that stakeholders must consider important ethical norms in their deliberations.
It has also been recommended that a study’s package of ancillary care should be defined after a ‘locally-driven deliberative process among concerned stakeholders’ to elucidate their preferences (Hyder & Merritt, 2009, p. 430). Some commentators have recommended that communities should engage in a process of bargaining with, or negotiating with, researchers for a wide range of benefits, including care (Participants, 2004). This so-called ‘fair benefits’
approach aims to respect the autonomy of host communities, and facilitate free decision- making. This approach also aims to assist research stakeholders to reach outcomes that are fair, ensuring that participating communities are not exploited (London & Zollman, 2010).
Proponents of this approach argued that exploitation is best avoided by ensuring that people
who assume the research burdens receive fair benefits, more specifically that ‘benefits should correspond to burdens, benefits to others and relative contributions’ (London & Zollman, 2010, p. 37). One of the recommended criteria for fair benefits was the provision of collateral health services to participants or participating community - health services beyond those required for conduct of the research (Participants, 2004). Therefore on the fair benefits approach, access to ancillary care (care not required for science or safety) was considered to be one possible benefit that host communities could negotiate with researchers. Even accounts based on rectifying social inequalities between sponsor and host countries have recommended consultation with the community to identify the needs and care elements most important to the host population (Shapiro & Benatar, 2005).
Critics of the fair benefits approach have argued that it does not set out the relationship between a process of negotiation, on the one hand, and its claims about what constitutes fair benefits, on the other hand (London & Zollman, 2010). Critics have argued that sometimes the fair benefits approach sounds like a pure procedural approach where an outcome is regarded as fair when it is produced by a particular procedure and when outcomes that do not satisfy certain substantive conditions still count as fair as long as all parties accept them.
Critics argue that at other times it sounds like an imperfect procedural approach where there are some restrictions on the outcomes considered acceptable, and where outcomes are considered fair ‘according to some independent standard or criterion of fairness’ (London &
Zollman, 2010, p. 42).
Critics argued that if the fair benefits approach is an imperfect procedural approach, then fair-benefits proponents must provide an account of how host communities should negotiate with researchers so that resulting bargains satisfy certain substantive conditions of fairness (London & Zollman, 2010). It has been asserted that unless the fair benefits approach is better specified, then it is possible it results in a ‘race to the bottom’ (London & Zollman, 2010, p. 41) where communities compete against each other by trying to make themselves more appealing hosts by lowering their costs, and where investigators are tempted to locate their research projects in communities with the lowest costs. Others have questioned whether communities could ever have equal bargaining power with sponsor-investigators that would enable them to negotiate a fair amount of the benefits (Schϋklenk, 2010) and that
negotiations run the risk that outcomes are determined by the opinions of the majority or the most powerful or the loudest (Stobie & Slack, 2010).