CHAPTER TWO LITERATURE REVIEW
2.3 THE DEBATE ABOUT CARE IN HIV VACCINE TRIALS
2.3.4 MODELS OF ANCILLARY CARE
2.3.4.1 THE PARTIAL ENTRUSTMENT ACCOUNT OF ANCILLARY CARE
It has been argued that many of the previous arguments about sponsor-investigators’ care responsibilities that are based on ethical principles are somewhat unfocussed. For example, it has been argued that beneficence-based arguments are ‘undifferentiated’ (Richardson, 2008, p. 257). It has been asserted that duties of rescue applies to all persons (not just researchers) and apply when the need is dire and the needed intervention is comparatively simple, low- risk, or inexpensive to provide (Hawkins, 2008; Merritt, Taylor & Mullany, 2010; Richardson, 2008) - the so-called ‘easy fix’ (Merritt, 2011, p. 322). Some argued that researchers do not bear a special responsibility to remedy injustices that they did not cause (Dickert & Wendler, 2009). It has been noted that there has been inadequate justification for the obligations of researchers in particular to the health-care needs of participants (Participants, 2008) and inadequate justification for the claims that researchers in particular have a special obligation to address care needs (Richardson, 2008) – especially to provide more complex, lengthy or costly responses that go beyond what would be called for by duties of rescue (Richardson, 2009a; Richardson, 2012).
It has been argued that a sound justification for the obligations of researchers to address participants’ care needs lies in the relationship between researcher and participant, and from the transactions between them (Richardson, 2009b). Some commentators argued that the care debate has been characterised by extreme polar representations of researcher- participant relationship. On the one hand, researchers have been viewed as pure physicians (Richardson & Belsky, 2004) with a ‘therapeutic obligation’ (Miller & Brody, 2003, p. 24) where researchers’ care obligations are seen to extend very broadly to all aspects of participants’ health (Richardson, 2008). On the other hand, researchers have been viewed as pure scientists, where they are seen to have few care obligations (Richardson & Belsky, 2004) but rather obligations to implement the scientific protocol (Haire, 2012) or make decisions out of concern for the scientific design of the study (Rangel, 2010).
It has been argued that the most appropriate characterization of the relationship between researchers and participants lies somewhere in the middle, and is a relationship of partial entrustment (Richardson & Belsky, 2004). More specifically, that is, participants ‘entrust’ to
researchers a narrow subset of their health by granting express permissions for researchers to conduct specific trial procedures (for example, tests, blood draws) and that researchers come to accept responsibility to respond professionally to this specific medical information through their specialised skills and training (Richardson & Belsky, 2004).
Richardson (2008) set out that participants provide permission for researchers to do otherwise-impermissible things, such as to touch participants in certain ways, to collect tissue samples or bodily fluids, and to collect medical information about them that would otherwise be confidential. He argued that by soliciting these permissions, researchers implicitly agree to receive this private information and accordingly become entrusted with special responsibilities pertaining to this information, namely to respond appropriately and professionally (Richardson, 2008). That is, he argued that researchers have special responsibilities to research participants by virtue of their professional role (Richardson, 2008).
These entrustment-based obligations exist in addition to, or as a supplement to, or ‘over and above any more general positive obligations’ that are incumbent on any person (Richardson, 2008, p. 261; Richardson, 2012c). It was argued that this special responsibility is the core of researchers’ ancillary-care obligations (ibid).
On this account, researchers have special entrustment-based responsibilities to consider care for medical conditions identified by trial procedures (Richardson, 2007). Such conditions are considered to fall within ‘scope’ (Belsky & Richardson, 2004). These conditions may be of varying degrees of scientific importance to the study (more below) but on this account all conditions identified by modes of information-gathering in the research generate potential entrustment-based claims for care. One of this model’s distinct contributions is to move beyond considering care only for conditions that are important to the study, such as trial endpoints (Participants, 2008). On this account, given aspects of participants’ health are considered to be entrusted to the researchers - and so to be within the scope of entrustment- based obligations - if researchers needed permission to collect information about them in order to proceed with their study (Richardson, 2008) or had to secure a privacy waiver from participants to identify them (Merritt, 2011). Proponents of the entrustment model therefore recognise the distinction between needs identified via research-related interaction versus needs identified by mere casual observation (Taylor et al., 2011).
Richardson (2007) asserted that a condition may be centrally within scope – that is it is very important to the research (for example, it constitutes the study endpoints) or clearly within scope, that is, it is a condition that is important to the study design but is not an endpoint or minimally within scope (that is, it is not important to the study). The model’s proponents have been careful to point out that all entrusted conditions generate potential claims to care and the endpoint is not necessarily privileged (cf. Participants, 2008). However, it has been implied that when a condition falls centrally in scope (and is important to the research) then this impacts on the strictness of the obligation to address it (cf. Richardson, 2007). For example, the obligation to ‘provide’ care for HIV in an HIV vaccine trial was seen to rest in part on the notion that HIV status is central to the research and that HIV acquisitions are scientifically important to the research (Richardson, 2007, p. 1960). On this account, however, the responsibilities of sponsor-researchers are not restricted to, or centered on, addressing target conditions (Participants, 2008, p. 0709). It is recognised that many needs will be encountered through study procedures (Participants, 2008). This model’s dissemination has coincided with increasing recognition that participants in HIV prevention trials present with multiple health threats – unintended pregnancies, STIs or other health needs (MacQueen &
May, 2008) including anemia, hypertension and others (Ramjee et al., 2010).
On this account, when a condition is identified by a trial procedure (or falls within scope) it means that participants have a potential claim that researchers should address their care need. Researchers need to consider a series of moral factors (discussed below) to assess the strength of this claim (Belsky & Richardson, 2004) and establish the strength of researcher responsibilities to address the ancillary care needs they identify (Participants, 2008). When the strength of these factors is considered ‘high’, then there is a strong claim that researchers must respond to the care need (Richardson, 2008) and ‘see to it that the person receives adequate care addressing that need’ (Richardson, 2008, p. 260). On this account, a test of strength must be satisfied, and if it can, the researchers who generated the finding have some obligation to see to it that the research participant gets appropriate care (Richardson, 2008, italics mine). It has been observed that the ‘appropriate moral response’ might ‘look quite different’ depending on the context (Richardson, 2008, p. 260) and that a wide range of responses is possible (Richardson, 2012c). But first, it would help to consider the factors
considered relevant to working out the strength of a participant’s claim that researchers address their need – including, gratitude, engagement and vulnerability (Richardson, 2007).
More specifically, the factor of gratitude is assessed by considering the uncompensated risks and burdens assumed by participants (Belsky & Richardson, 2004) or their undergoing of procedures that may be risky, painful or inconvenient (Richardson, 2008). The factor of engagement is assessed by considering the depth of the relationship between researcher and participant based on the length (Belsky & Richardson, 2004) and intensity (Richardson, 2007;
Richardson, 2008) and extensiveness of the proposed interactions between researchers and study participants (Participants, 2008) that can be expected on the basis of the protocol (Richardson, 2007; 2008). Engagement or depth can be minimal (for example, screening protocols where persons undergo some procedures to establish their eligibility); low (for example, studies where there a few brief interactions); medium (for example, studies where there are many interactions over a number of years; and high (for example, studies with many follow up visits and intensive monitoring) (Richardson, 2007). It is asserted that when the relationship is deeper, researchers have a stronger moral responsibility to engage with participants’ needs (Belsky & Richardson, 2004). The factor of vulnerability is assessed by considering how badly off participants would be if they did not receive help (Richardson, 2007), how much difference getting care would make to their health and welfare (Richardson 2008) or how severe/ acute the need is and what would be the consequences were the need to go unmet (Participants, 2008).
The model’s proponents asserted that the appropriate response will depend on the context (Richardson, 2008) and that gradations of responses are possible (Richardson, 2007). Merritt (2011) acknowledges that the possible range of responses extends from doing nothing to address the need, on the one hand, to making it one’s most urgent priority, on the other hand. She asserts that the core issue is identifying – from all the options – those actions researchers must take (Merritt, 2011). On the partial entrustment account, researchers must assess the context, namely what alternatives are available such as the existing health-care system or other health-care opportunities and whether the identified need can be met by these alternatives bearing in mind possible constraints on infrastructure and personnel.
Where participants have a strong claim to care based on gratitude, engagement and
vulnerability, then even fairly demanding responses (such as direct provision of care) must be entertained (Joseph Millum, personal communication, June 2011). However, the model acknowledges that there must be limits on potential responses – a so-called ‘threshold of costliness’ (Richardson, 2012, p. 407) to prevent them from becoming ‘relentlessly demanding’ (Merritt, 2011, p. 321).
More specifically, decision-makers must assess the ‘costs’ of the response which can be considered low (negligible), serious or heavy in relation to the overall budget (Richardson, 2012c). Costs in terms of financial resources (money) as well as costs of human resources (personnel) in terms of diverting study staff must also be considered. Costs related to confounding study results (Belsky & Richardson, 2004), undermining study power (Richardson, 2007), or interfering with the study’s scientific aims must also be considered. On this account it appears that where the response will not overwhelm the study (Merritt, 2011) nor overwhelm the study activities (Richardson, 2012) nor seriously distract researchers from their core work (Richardson, 2009b) nor confound the science then the response should be implemented. Merritt (2011) acknowledged that it is a matter of judgment to determine whether the costs of various responses will be acceptable or inordinate, and to establish a
‘principled cut-off’ between acceptable and excessive costs (p. 342).
This account does recognise however that responsibilities to implement extra-scientific responses, or ancillary-care responses are not unbounded and this account respects the central goal of research (generating generalizable knowledge) as a valuable one (Rangel, 2010). This account allows, therefore, that responsibilities to their scientific mission (and benefitting a future collective) may legitimately limit researchers’ ancillary-care responses to participants (Richardson, 2009b). As such, ancillary-care responses do not necessarily comprise ‘unrestrained obligations’ (Richards & Helmchen, 2012, p. 2).
This framework has been expressly applied to the issue of HIV vaccine trial participants needing ART in a context where it is not accessible in the community (Richardson, 2007).
Richardson (2008) observed that HIV vaccine trials introduced a difficult ethical question, namely: ‘do the researchers or their sponsors have any obligation to help secure ART for trial participants who become HIV-positive during the course of the trial?’ (p. 257). Richardson
(2008) noted that such treatment for HIV vaccine trial participants falls into the definition of ancillary care because it is care that participants need, but is not covered by a previous rationale such as safety or promise, or compensation and providing ART does not contribute to the scientific aims of the trial.
Richardson (2007) applied this framework to HIV vaccine trials to provide a way to work out the comparative strictness of researchers’ obligations to provide ART (viewed as a type of ancillary care) while acknowledging the range of potential responses (Richardson, 2007). It was noted that HIV falls into the scope of investigators’ moral concern because HIV is explicitly diagnosed in such trials from a special authorization granted by participants (Richardson, 2007) and furthermore that HIV falls centrally within scope because tracking participants’ HIV status is central to the study (Richardson, 2008). It was argued that the strength of the investigators’ entrustment-based obligation to provide ART would be heightened by the fairly long interaction required by phase III HIV vaccine trials (engagement); the number of risks and burdens assumed by participants (gratitude); the suffering should HIV go untreated (vulnerability); and the few reasons against providing care in this case because the costs of providing ART in phase III trials were judged to form a low proportion of the overall trial budget (Richardson, 2007). It has been claimed that all the factors impacting researchers’ care responsibilities can be examined at the early stage of protocol review on the basis of the study design (Richardson, 2008) and that RECs are a natural venue for consideration of such issues (Richardson, 2009b).