CHAPTER TWO LITERATURE REVIEW
2.4 RECOMMENDATIONS IN ETHICAL GUIDELINES
2.4.2 GUIDANCE SPECIFIC TO SOUTH AFRICAN HIV VACCINE TRIALS
2.4.2.3 GUIDELINE RECOMMENDATIONS FOR ENGAGEMENT
Ethical guidelines also seem to agree on a series of engagement practices to ensure care for participants, volunteers and even participating communities. Ethical guidelines recommend assessing health services, more specifically that there should be a sound appreciation of existing health-care (SA MRC, 2003); that capacity to deliver HIV services should be explored (UNAIDS/WHO, 2007; 2012) and services for HIV and non-HIV care (and capacity) should be identified (UNAIDS/AVAC, 2011). Likewise, ethical guidelines agree on the need to build capacity of local systems (SA MRC, 2003; UNAIDS/WHO, 2007; 2012); more specifically to build capacity of trial-linked health care centres to deliver HIV services to the host community (SA MRC, 2003); and to strengthen local and national capacity to deliver the highest possible level of HIV services through strategic investment and development of trial-related resources (UNAIDS/WHO, 2007; 2012). Somewhat strangely, UNAIDS/AVAC (2011) no longer has a specific capacity building recommendation, unlike its predecessor (UNAIDS/AVAC, 2007).
Ethical guidelines agree on assessing conditions in the community, namely that researchers should have a good understanding of the health context of the community where the research will occur (SA MRC, 2003); and that vulnerability determinants should be analysed such as health conditions in participating communities (UNAIDS/WHO, 2007; 2012).
Ethical guidelines also agree that care is best implemented through partnerships between researchers and other key stakeholders. UNAIDS/WHO (2007) recommends that sponsor- investigators should collaborate with governments to strengthen HIV services to deliver the highest possible level of services, and that there should be agreements between partners regarding care (even while asserting that the local health-care system is primarily responsible for providing care services). UNAIDS/AVAC (2011) recommends that HIV care discussions clarify responsibilities between sponsor-investigators and health institutions regarding financing/ delivery of HIV services. SA MRC (2003) does not address partnership directly but
implies this approach in use of the term trial-linked centres. These recommendations reflect some consensus that – as treatment services become more scaled up in many countries–
researchers should enter into strategic collaborations with service-providers to ensure needs are addressed (Macklin, 2008; Macklin 2010; MacQueen & May, 2008; MacQueen et al., 2008). These recommendations also imply that the most common response to needs will be referral or assisted referral to national programs, however one guideline states that there could be direct provision of selected services to HIV-infected participants until they are eligible for national programs (UNAIDS/WHO, 2007; 2012).
There are also several recommendations that implicate review by RECs. One ethical guideline asserts that care and treatment issues should be reviewed, more specifically, that reviewers should consider support, care and treatment to participants and to the community (UNAIDS/WHO, 2007; 2012). Another recommends that protocols should spell out expected benefits, which include access to HIV care (SA MRC, 2003) while another recommends that protocols should specify the procedures and interventions required for the research, and associated benefits, plus other ancillary interventions, services and products, and associated benefits. Listed benefits include: a care and treatment package for HIV infection, reproductive health care and contact with health-care workers (UNAIDS/WHO, 2007; 2012).
UNAIDS/AVAC (2011) does not specify what should be in protocols with regard to care, only that teams/ stakeholders should discuss both HIV and non-HIV care during protocol development. These recommendations suggest some agreement that reviewers should have sight of the care steps that researchers plan to implement (cf. Participants, 2008) so that they can judge the adequacy of the proposed responses.
Ethical guidelines also make recommendations for consent materials and consent processes related to care. They assert that care for HIV infection should be in informed consent forms (UNAIDS/AVAC, 2011). They agree that participants must understand the care available to them if they get HIV infection (SA MRC, 2003; UNAIDS/WHO, 2007; 2012) and that stakeholders should discuss how to ensure awareness of HIV care-access (UNAIDS/AVAC, 2011). These recommendations suggest ethical guidelines agree that participants themselves should have a good understanding of care, even though the emphasis appears somewhat narrowly focussed on HIV care, and neglects to mention that participants should understand
fairly broadly how their needs will be addressed (cf. HPTN, 2009) especially as such issues are likely to be important to participants hoping to process the personal implications of trials (Lindegger & Richter, 2000; Lindegger et al., 2006).
Ethical guidelines all agree that stakeholders (including community representatives) should be involved in care decisions. More specifically, community representatives should make inputs into decisions regarding treatment and care linked to the research, such as helping researchers to work out how capacity should be built in local systems (SA MRC, 2003).
Furthermore, research teams should discuss with relevant stakeholders HIV care (numbers, package, national guidelines and laws, mechanisms) and clarify responsibilities on financing and delivery of services (UNAIDS/AVAC, 2011). Research teams should discuss non-HIV care, both protocol-required services and additional services that community stakeholders would like to see offered to participants by the site (as well as strategies and impact).
UNAIDS/AVAC (2011) asserts that negotiating the range of non-HIV related services will help ensure stakeholders understand available services. This reflects the understanding that there is an important role for community stakeholders in the care debate (MacQueen & May, 2008;
Vallely et al, 2009) even while ethical guidelines emphasize slightly different practices (discussing, seeking inputs, negotiating). SA MRC (2003) and UNAIDS/WHO (2007) appear to recommend consultation about HIV care, whereas UNAIDS/AVAC (2011) recommends discussion about HIV care and non-HIV care, reflecting some awareness that the debate has moved beyond care for the endpoint (HIV) alone to encompass care for other conditions (cf.
MacQueen et al., 2008; Participants, 2008).
UNAIDS/WHO (2007; 2012) states that there should be an on-going iterative consultative process to facilitate national decision-making about care and treatment (under a guidance point on benefits). It states that there should be a transparent, meaningful, participatory process that should involve all stakeholders before a trial starts to agree on the level, scope and duration of care and treatment (under a guidance point on treatment). It states that trials should not proceed unless all stakeholders have reached consensus on access to care and treatment (under the introduction). UNAIDS/AVAC (2011) does not have a consensus requirement, nor SA MRC (2003). Ethical guidelines recommend that approaches for access to HIV care be documented (UNAIDS/WHO, 2007; 2012) and that stakeholders discuss and
monitor these as well as document discussions (UNAIDS/AVAC, 2011). SA MRC (2003) does not address this issue. These recommendations reflect emerging awareness that stakeholders should be sufficiently engaged about care approaches to prevent misunderstandings and allegations of unethical conduct (Koen et al., 2012; McGrory, Irvin &
Heise, 2009). These recommendations recognise that the multiple stakeholders who will be impacted by care-implementation need to be engaged early (Tarantola et al., 2007) and that evaluating the merits of various strategies can help strengthen such efforts (McGrory et al., 2009).
It is worth noting that SA MRC (2003) has the caveat that ethical standards should be enhanced by community consultation, whereas UNAIDS/WHO (2007) does not specify how the consultation process should be conducted in such a way that outcomes still meet other substantive requirements for care, for example that it be high quality (cf. London & Zollman, 2010).
Ethical guidelines present readers with several ethical rationales for taking steps to address medical needs in trials. Ethical guidelines refer to compensation for harm reasoning namely the possibility that participants might experience risk compensation from believing they are protected from HIV or that participants who are vaccinated and subsequently HIV-exposed may be more susceptible to HIV infection (SA MRC, 2003). Ethical guidelines refer also to beneficence-based reasons such as the need to actively promote the welfare of participants by addressing their HIV-related needs (SA MRC, 2003, UNAIDS/WHO, 2007) and to contribute to their welfare by ensuring access to non-HIV care (UNAIDS/ AVAC, 2011). Ethical guidelines also allude to justice-based reasons for ensuring access to HIV-care, namely, the need to reduce inequities in health-care between participants in sponsor and host countries (SA MRC, 2003) or to treat like cases alike by ensuring participants in high and low income countries are treated equally regarding access to HIV treatment and care (UNAIDS/WHO, 2007; 2012). The principle of justice as reciprocity is also briefly invoked by ethical guidelines as relevant to HIV care - insofar as UNAIDS/WHO (2007) asserts that participants should receive something in return for their time, inconvenience or discomfort.
From the review above, it is clear that ethical guidelines invoke a range of rationales for why care-related needs should be addressed. They make a series of recommendations about the steps that researchers should take in relation to participants’ needs, and imply standards for researchers to strive for. They make recommendations about how various stakeholders should be engaged in care decision-making and implementation. Some have contended that the UNAIDS ethical considerations represent ‘an ideal’ (Macklin, 2010a, p. 202) and that
‘strict adherence’ may be hard to achieve in part because ‘ancillary medical care is often not readily available’ in resource-limited settings (Macklin, 2010a, p. 199).