CHAPTER FIVE DISCUSSION
5.5 PARTNERING
5.5.4 SITE-STAFF AND COMMUNITY REPRESENTATIVE INTERACTIONS
Proponents of ancillary-care have alluded to the role of community in ensuring ancillary care.
For example proponents of the ‘Four Ps’ approach have asserted that ancillary care plans should be developed in ‘dialogue and partnership with the host community, in ways that maintain respectful interaction (…) and represent the population of potential participants, Community Advisory Boards and the local medical community’ (Participants, 2008, p. 0712).
Hyder and Merritt (2009) have argued that a study’s package of ancillary care should be defined after a ‘locally-driven deliberative process among concerned stakeholders’ to elucidate their preferences (p. 430).
Practices described by site and network representatives to involve community representatives in protocol development, to involve site-level CAB members in protocol or materials review, to discuss with CABs the sites’ approach to care, to respond to their ad hoc questions about care, and to seek CAB inputs on how to implement care approaches corresponded with recommendations to dialogue with host-community representatives about ancillary care (Participants, 2008). Site-staff practices reflected some effort to integrate community perspectives at various stages of trial design and implementation (Heise et al., 2008) as well as to hear suggestions for how care could be improved or delivered (Vallely et al., 2009). Reported practices did not include bargaining or negotiating with CAB representatives about additional substantive benefits as found in previous empirical explorations (MacQueen et al., 2008) or as recommended by some ethics commentators, namely that researchers should negotiate or bargain with participating communities to allow them to identify ‘valuable’ health-related benefits including ancillary care (Participants, 2004;
Weijer & LeBlanc, 2006, p. 805/6). In future research into strategies for engaging community, perspectives about ‘negotiating’ with communities should be more fully explored, which is a point made again under recommendations for additional research.
Previous research has pointed to CAB presence and activity as a central feature of contemporary HIV prevention trials (MacQueen & May, 2008; MacQueen et al., 2008) although clearly engagement strategies should be more diverse and multi-faceted than CABs alone (MacQueen et al., 2012; UNAIDS/AVAC 2011; West Slevin, Ukpong & Heise, 2008). This study did not identify major concerns about insufficient practices to engage CABs in care decisions and implementation as found by Heise et al. (2008) but did identify subtle tensions and complexities with site-staff-community partnerships, detailed below.
Firstly, CAB members at some sites questioned not being allowed direct access to trial participants to explore participant experiences and respond to participant concerns. They questioned whether site-staff could be doing more to enable their access to participants.
Proponents of ancillary care have recommended that the experiences of participants be actively gauged (Participants, 2008; Richardson, 2012c) and one helpful strategy may be to get CAB members to canvas such views – for example to explore the quality of the ancillary care approach. Direct access to participants by CAB members should only occur where
participants give permission for their identity as participants to be made known in this way, given need to respect confidentiality preferences (Emanuel et al., 2000; UNAIDS/WHO, 2007;
2012). Direct access to participants by CAB members should also only occur when CAB members are sufficiently familiar with HIV vaccine trials, and sufficiently trained to protect confidentiality, and more generally capacitated in accordance with recommendations for resourcing CABs (UNAIDS/AVAC, 2007; 2011; UNAIDS/WHO, 2007; 2012). Where the above cannot be guaranteed, presumably there are other strategies available to assess whether participants are in reality receiving the planned ancillary-care, such as monitoring by site-staff of whether participants take up direct and indirect care, and assessing the quality of their care experiences. Even where direct access by CAB members to participants is not permitted, CAB members can increase their visibility to participants through posters and contact details on consent forms. This tension does suggest that guidance on ancillary care should help stakeholders identify helpful strategies to get participants’ feedback on their ancillary care experiences.
Secondly, site staff questioned the soundness of some community viewpoints, for example, requests for non-evidence-based care, and questioned whether such views should be
‘allowed’. This empirically-identified complexity suggests that ancillary-care guidance should help stakeholders manage inputs solicited via consultation that might be inconsistent with sound ancillary care for participants. This concern supplements concerns about CABs already identified in the literature, namely that CABs can become co-opted by the research process (UNAIDS/WHO, 2006), can become dominated by political or other agendas, are financially dependent on researchers, have competing priorities in resource-limited settings (West Slevin et al., 2008) may lack representative and accountable members (Hankins, 2006) and may lack negotiating power (Haire et al., 2012). As set out in Slack (2014) this issue also appears inadequately addressed in current ethical guidelines which are generally silent about what should be done when solicited views conflict with other substantive norms, for example, to provide optimal care (UNAIDS/WHO, 2007; 2012; UNAIDS/AVAC, 2011). SA MRC (2003) gestures at this issue, setting out that community participation should enhance the ‘ethical soundness’ of an HIV vaccine trial, suggesting that inputs undermining ‘ethical soundness’
might be legitimately rejected. Ethical guidelines should take a stand about about how to proceed when inputs solicited in a consultation process conflict with substantive recommendations for ancillary care, as this might encourage even more active solicitation of
community views (Slack, 2014) which is a point made again in the next chapter. It is also possible that concerns about unreasonable inputs might explain the few ‘negotiating’ or
‘bargaining’ practices reported here.
This data suggests that efforts to engage CABs to improve ancillary-care decision-making and implementation should be continuous and even intensified (Slack, 2014). On several accounts of ancillary-care, researchers are encouraged to have a good understanding of the available care facilities and alternatives (Participants, 2008; Richardson, 2012c) and community consultation may provide researchers with a deepened understanding of the quality of these care facilities, which in turn will help them work out the precise response they should implement (for example, refer to such facilities or provide services onsite).
Furthermore, on accounts of ancillary care that value reciprocating for participants’ risks and burdens (such as partial entrustment and whole person accounts), it is possible that consulting community representatives may assist researchers to better understand risks and burdens assumed by participants from their perspective, for example, there could be risks, like stigma, that are culturally informed and hidden from researchers (cf. Dickert &
Sugarman, 2005). On accounts of ancillary care (like partial entrustment and whole person accounts) that value concepts of engagement between researcher-participant, community consultation could enhance such assessments, for example there could be cultural factors influencing the intensity of the interaction between participants and researchers. Therefore, consultation with community representatives might make the analysis of key factors in ancillary-care accounts more precise, and influence the precise responses that researchers implement.
This data suggests that sites should create a space for critical reflection about policies for CAB/participant interaction (such as direct access to participants), and for formal review of ancillary-care approaches. The latter may be assisted by the better preparation of written materials about the site’s approach (especially for non-HIV needs) to ancillary care – for example, a document entitled ‘Our site-specific approach to helping participants get care for their medical problems identified in trials’ setting out in clear terms the proposed strategies.
Formal space and time for reflection on the care approach with community representatives will go some way to achieve the openness about arrangements recommended by Richardson
(2012c). It would also go some way to discuss expectations, incorporate opinions and address concerns about ancillary care recommended by AVAC (2012) and will enable even more impact by community representatives on ancillary-care planning and implementation. It is also likely to consolidate trust theorized to underpin solid engagement (MacQueen et al., 2012). Network/ site representatives should also collate and distribute to affected CABs the care-related concerns identified by community representative in protocol-development in network and site-level discussions, and how they were addressed (Slack, 2014). These are points that will be returned to in the final chapter where recommendations for stakeholder practices are made.