CHAPTER FIVE DISCUSSION
5.3 PRIVILEGING
as part of an internal ancillary-care review, which is a point revisited under recommendations for practice in the next chapter.
to respond in the contributions that participants make, they did not always share an identical understanding of what response was owed.
These findings resonate with observations in the literature that, even when obligations are viewed as rooted in reciprocity, questions will still remain about the extent of the response (Millum, 201o). More specifically, Millum (2010) argued that the return, or reciprocal benefit, or what participants are owed (from those who have invited participation) should be appropriate to the contribution made by participants including costs incurred and extent of the benefit provided by the research. Merrit and Grady (2006) argued that the return from those who stand to benefit should be proportionate to the sacrifice made by participants.
Millum (2010) noted if the participants incur substantial costs or if the benefits generated by the research are great enough, then sponsor-investigators may have responsibilities to take demanding steps to address medical needs.
These findings suggests that stakeholders agree that participants should get some ‘special care’ (Richardson, 2012, p. 122) but there is some within-person and between-person conflict about precisely how much special care they should receive – what is a proportional response?
This finding shows that many stakeholders do not support ‘interpersonal equality’ between participants and non-participants (cf. Merrit, 2011, p. 330) but they still have some concerns about how much deviation from treatment-for-citizens is acceptable – how much better should the approach be for participants versus others? That is, these findings indicate that these stakeholders do not necessarily have discomfort about individual attention per se being paid to participants (Lo et al., 2007) but they have concerns about the degree of attention to be paid them. These findings suggest that stakeholders do have concerns about how people inside a trial and people outside a trial based in the local community are treated (Haire, Folayan, Hankins, Sugarman, McCormack & Warren, 2013). That is, stakeholders do have concerns about prioritizing the interests of participants in relation to non-participants (cf.
Merritt, 2011). They do not appear to reject it outright, but rather they question how much special treatment is acceptable, or they do not share the same understanding of how much special treatment is acceptable.
These findings suggests that ancillary-care guidance will not need to convince stakeholders about why it would be acceptable to treat participants partially (remember they invoked reasons under the first theme that would support this) but it should try to provide guidance on how much deviation from how everyone else is treated is acceptable (cf. Brownsword, 2007) or how much deviation from impartial treatment is allowable (cf. Merritt, 2011). This suggests that it would be especially helpful for vaccine stakeholders if guidance tries to help with establishing the ‘dosage’ of differential treatment. Guidance may need to better spell out the need to consider whether responses are proportional to the contribution being made by participants; or whether the benefit is appropriately sized. This point is revisited in the next chapter.
This complexity (within-person and between-person disagreement about the proportional response) suggests that a possible solution would be on-going reflection and consensus- building about what responses would constitute appropriate or proportionate responses to participants’ contributions. It is possible that the lack of agreement seen in this study about the precise response owed to participants (captured here under this third master theme) is linked to differing notions of what is contributed by participants (captured under the first master theme). This point is re-visited under recommendations for practices.
The findings also showed that site-staff actually recognized that participants are in fact somewhat privileged in relation to citizens (they understand participants as receiving a reciprocal return or getting a benefit that citizens do not) (‘recognizing some privileging of participants over citizens’). But site-staff appeared ambivalent about declaring these advantages in protocols and consent forms. Medical benefits reportedly associated with research procedures themselves (for example, serial monitoring that allows early referral for ART) and medical benefits reportedly associated with care strategies for identified conditions (for example, less time-wasting if STIs are treated onsite) were not stated in protocols or consent forms as potential benefits. That is, despite understanding that some advantages accrue to participant, such advantages were not readily declared in these written documents (Slack, 2014) (‘not declaring benefits in ICFs/ protocols’). It seems that not declaring benefits is not because researchers are lazy, or distracted but may be because they are uncertain about
proportional returns or appropriately sized benefits for participants (relative to non- participants). This is an issue worth further exploration as recommended in next chapter.
Site-staff and network representatives were also concerned that if participants were given too much special treatment then citizens might want to become participants too uncritically (‘worrying about the consequences of special treatment’). These stakeholders were concerned about the consequences of broadcasting special treatment, namely, that informing participants about the return or the benefit might make citizens make poor decisions about being in trials. Here concerns were that people would be inappropriately induced (or even
‘coerced’) into trial participation if they knew at the outset that they would be getting better care than non-participants, or if they knew how much better that care would be.
This concern resonates with theoretical debates about the impact of offers (and even threats) on voluntariness of participation (Appelbaum, Lidz & Klitzman, 2009) and consensus that participants should make decisions free from substantial controlling influences (Grady, 2002) or free from external, intentional and illegitimate influences (Appelbaum et al, 2009). The latter includes so-called undue inducements - defined as an excessive offer that distorts the processing of risks or causes the devaluation of risks (CIOMS, 2002; Emanuel, 2004; Slack et al., 2005). Concerns that ancillary care might lead participants to discount risks have long been registered (Dawson, Klingman & Matarazzo, 2014). Rebuttals include that undue inducement is minimized where offers are modest (Emanuel, 2004), where consent strategies are implemented to assist participants to carefully process risks (Slack et al., 2005) and where research risks are reduced to an acceptable level by competent ethical review (Emanuel, 2004). Also, efforts should be made to ensure that offers are well reasoned or well justified.
Ethical commentators have also argued that offers of improved medical care can never constitute coercion because offers are not direct threats that will leave participants worse off than they were before the interaction with researchers (Emanuel, Currie & Hermans, 2005;
Hawkins & Emanuel, 2005). Ethical guidelines also take this issue head-on by stating that undue inducement concerns are often inappropriate (cf. UNAIDS/WHO, 2007; 2012).
Despite this scholarship and guidance, this data suggests that impact-on-decision-making is
guidance should address the issue of undue inducement and coercion in some detail, with more explication of strategies to offset such concerns, including consent processes to ensure good decision-making in the face of ancillary-care benefits.
It is worth noting that no vaccine stakeholder here spontaneously raised the concern that upfront disclosure of potential trial-associated benefits (either benefits from research procedures or benefits associated with ancillary care) would cause a ‘therapeutic misconception’ in participants (cf. Appelbaum et al., 1987). Concerns about the therapeutic misconception are that patient-participants may misconceive the intentions of researchers and research (and research procedures) as therapeutic (Litton & Miller, 2005) or may have the false belief that the study as a whole and specific study procedures in particular ‘are designed to provide personal medical benefit’ (Miller et al., 2008, p. 271) or have an unreasonable appraisal of the medical benefits associated with participation due to misperception of the nature of research (Richardson, 2012c). It is possible that research stakeholders do in fact have some misgivings about disclosures of benefits grounded in worries about the therapeutic misconception but these were never spontaneously volunteered, and this should be explored in further research (a point returned to later). Regardless, it would appear that concerns about the therapeutic misconception could be offset by careful consent strategies (cf. HPTN, 2009) or by clear communication about the distinctions between research versus care components (Presidential Commission, 2013) and therefore such concerns would not provide good grounds to strip out all benefits associated with implementing ancillary-care responses.
It is important for ancillary-care guidance to address both concerns (both about how much advantaging is acceptable and about the consequences of advantaging) because until this is achieved stakeholders are likely to resist instructions to include fuller descriptions of benefits in written materials. The quick-fix solution would be to instruct site-staff to do better written disclosure about benefits, but the underlying worries would remain unaddressed. Not detailing potential benefits does have consequences. When anticipated benefits are not declared in protocols then reviewers cannot judge their appropriateness, which is considered to be a key task in ethical review (UNAIDS/WHO, 2007; 2012). Furthermore when anticipated benefits are not declared in consent-related material then it may undermine participants’
comprehension of the personal implications of their participation (Lindegger & Richter, 2000;
Lindegger et al., 2006) or the ‘research ‘impact’, including ‘additional potential for clinical benefit’ (Wendler & Grady, 2008, p. 207). Participants’ understanding – including of potential benefits - should be facilitated by providing them with appropriate written material (Woodsong & Abdool Karim, 2005) and by regular verbal discussions with site-staff (cf. Flory
& Emanuel, 2004).
Some commentators have asserted that far more attention should be paid to considering whether potential benefits to participants ‘can reasonably be claimed’ and if so how they should be described in the consent form and process (King, 2000, p. 332). King (2000) argued that claims of potential benefit should be supported by actual evidence and then consent material should contain carefully crafted, detailed statements about potential benefits. The findings here (that consent materials say little about the benefits that are believed to accrue to participants from research procedures or ancillary-care responses) suggest that written materials are relatively silent on what King (2000) terms collateral benefits to participants arising from design features such as physical examinations, monitoring, tests but also including so-called free care or other extras. These collateral benefits are considered distinct from direct benefit to participants arising from the experimental intervention and distinct from aspirational benefit to future persons and society arising from the research results. The findings here suggest that relative silence on collateral benefits may be linked to concerns about the impact of inducements on participants’ decision-making. This is despite recognition in the literature that participants’ motivations for research may well stem from the hope of collateral benefits, and not only from the desire for aspirational benefit to society (altruism) or the chance of benefit from the experimental intervention (King, 2000).
The findings here do indicate that stakeholders had two distinct sets of concerns about privileging participants in relation to citizens – they have concerns about how much to do it, and they have concerns about declaring it. These imply different solutions. The former problem needs better guidance for how much privileging is acceptable (and needs to be convincing about how much of a return or benefit participants deserve in relation to citizens or the most appropriately dosed response) and the latter problem needs better guidance about why privileging might not necessarily undermine decision-making. Taken together
(and a point I will return to in in recommendations for ethical guidance), these findings show that stakeholders need some help establishing the appropriate degree of benefit for participants related to ancillary care. Additional research could explore the discomfort around benefits more fully (see recommendations for future research).
Site-staff implemented some responses to assist volunteers being screened for trials with their medical needs, and to assist general community members with their medical needs, perhaps to offset some discomfort about privileging participants. Previous empirical explorations also found that site-staff undertook various practices to help non-participants get their medical needs addressed (Heise et al., 2008; MacQueen & May, 2008). Practices found in this study tended to exceed what ethical guidelines require for volunteers and underscore that ethical guidelines are a little ‘thin’ on actual direction for volunteers (cf.
Slack, 2014). Ethical models such as partial entrustment and whole person would allow that less is owed to volunteers screened out than is owed to participants actually enrolled (because there would be less indebtedness for risk and burdens, and less engagement, in brief screening protocols than in actual HIV vaccine trials) and they would allow that more is owed to volunteers enrolled in screening protocols than citizens enrolled in no protocols – which is an approach consistent with the actual conduct of researchers in this study.
Site-staff also implemented various strategies to address participants’ needs that indicated that participants at some sites were likely privileged over participants at other sites (for example, some sites offered onsite treatment for STIs or other ailments, preventing timewasting, whereas other sites did not; and one site referred participants to private-sector practitioners for some general ailments whereas no other site did so; and sites referred to off- site facilities of varying quality). These stakeholders expressed little conflict about between- participant differences and in fact variable strategies for meeting participants’ needs were endorsed if not downright valued.
Prior explorations have identified that sites address needs via a combination of direct or indirect (referral) strategies (Heise et al., 2008; MacQueen et al., 2008). As set out in Slack (2014), some commentators have called for a standard ‘approach’ to care services (Ngongo et al., 2012, p.2). Others have asserted that there is no single solution to addressing participants’
care needs (MacQueen et al., 2008) even while voicing concerns about comparability of care across sites (MacQueen et al., 2004). While sites can aspire to similar strategies (for example, onsite provision of treatment for STIs with associated advantages) it may be constraining to mandate this because it disregards the unique context and situation of different sites.
Instead, site-staff should be alert to quality problems with all strategies, as part of an ongoing commitment to reflect regularly on their ancillary-care approach, which is a point made in recommendations for practices. Calls for ‘standardization’ of care approaches (cf. Ngongo et al., 2010) need critical engagement, because findings here show that various strategies and referral sites are utilized (that is, the ‘seeing-to-it’ of participants needs differs across sites within the same country) with embedded quality differences for participants across sites, but that flexibility is endorsed and valued. These findings suggest that guidance on ancillary care should address whether (or how much) inter-site differences are acceptable. That is, comprehensive ancillary-care guidance will need to offer good reasons for why it is acceptable to depart from a more impartial, uniform approach to participants across all sites, and treat participants at different sites differently. Some commentators have already noted that more thought should be given to whether the needs of participants in a single study but across different sites should be treated differently (Richardson, 2012c) and this data underscores this observation, especially because site-staff appear to value the freedom to implement different responses at different sites, based on site characteristics and surrounding context.
Current ethical guidelines offer very little direction on across-site, within-country differences.
Previous guidelines asserted that trial sponsors should ensure that ‘core elements of the package’ of care are consistent (UNAIDS/ AVAC, 2007, p. 29). This appears to miss the issue here – that participants access the same elements of care, but the strategy or the referral-site characteristics introduces modest but non-trivial quality differences between participants at various sites (Slack, 2014). More explicit direction on this issue is recommended. Current ethical guidelines speak to differences between countries, tending to argue that researchers reach for equivalent standards across country settings (UNAIDS/WHO, 2007; 2012). One might infer that the same is called for across ‘micro’ settings such as sites, however, an explicit stance on the issue would be helpful. This is a point returned to in the final chapter under recommendations for ethical guidance.
As set out under the results, no stakeholder here appeared concerned that special treatment of participants might set citizens back (by for example queue-jumping), but rather they appeared concerned that citizens may be excluded from benefits that participants get.
Furthermore, steps taken for participants would not appear to demonstrably set non- participants back (Merritt, 2011). For example, representatives from all sites described assisted-referral steps for HIV (such as checking participants’ referral preferences, securing participants’ permission to share medical information about HIV, developing plans for referral) and some sites reported additional practices (such as booking appointments, alerting referral sites, accompanying participants, and intervening at referral sites). There is little reason to believe that such practices would take much away from non-participants.
Because participants were serially monitored and referred promptly for ART (with their evaluation results) such monitoring does not have to be provided by public-sector facilities which potentially frees up finite resources to be used for non-participants (cf. MacQueen et al., 2006; 2008). This suggests that steps for participants do not divert or displace resources away from non-participants (Richardson, 2012c) leaving non-participants worse off than they were before but rather that the interests of citizens are not advanced as much as participants.
These findings do not suggest that vaccine stakeholders need clearer reasons for why researchers should prioritize participants over non-participants (the reader will remember most stakeholders invoke reasons that would support this view - such as reciprocating for participants’ contributions, staying involved with participants, conferring benefits on participants). However these findings do suggest that stakeholders need help with the proportionality of responses, and extent of benefits, as well as the consequences of privileging for decision-making and therefore that ethical guidance should assist with these concerns.