STUDY AIMS AND METHODOLOGY
3.3 STUDY METHODOLOGY
3.3.1 BACKGROUND AND REFLEXIVITY
At the time of conducting this study, I had been working for more than a decade (since 2000) as the Project Coordinator for a research and resource-development group focused on ethico-legal complexities in HIV vaccine trials, namely HAVEG based at the University of
KwaZulu-Natal (UKZN), South Africa. Our group was funded by SAAVI to conduct research into core complexities and implement capacity-building initiatives for stakeholders in HIV vaccine trials. I was originally trained as a clinical psychologist, and had conducted my Master’s dissertation in ethical dilemmas of professional practice.
An early professional experience – with regard to the subject matter of this study - occurred in late 2002 where I was involved in hosting a HAVEG consultation (with key South African stakeholders) about various ethical complexities in HIV vaccine trials, including the issue of participants’ access to ART should they get infected during a trial. At this consultation it became apparent that certain REC representatives and certain investigators did not have the same understanding of the precise approach to be adopted should participants acquire HIV and need ART (at that time not available in the South African public health system), and did not share the same understanding of what the REC had approved in this regard. This led the REC to suspend enrolment of trial participants in the current HIV vaccine trial pending agreement on the approach and a commitment to ART-access for participants (cf. Altenroxel, 2002). I felt quite responsible for creating the meeting space in which this confusion had been identified, while realizing I had little control over the particular response subsequently implemented.
Thereafter, I was involved in a national consultation in early 2003 convened by South Africa’s Interim National Health Research Ethics Council to develop agreement about an interim measure to enable access to ART for HIV-infected participants, prior to roll-out of ART in the public health care system. As a result of these experiences, I assumed that stakeholders would likely have strong views about what was owed to participants with HIV (and possibly other health problems), that their viewpoints were unlikely to be identical, and that a complete consensus about the approach to be implemented in any one trial was likely difficult to achieve.
At around this time (2002), our group was also involved in adapting the international guidelines developed by UNAIDS for HIV vaccine trials (UNAIDS, 2000b) on behalf of the South African Medical Research Council that wished to add a booklet to their existing series of guidance booklets in South Africa (the others dealing for example with general
considerations, or animal ethics). One of the guidance points about which HAVEG received the most inputs from stakeholders was the guidance point addressing treatment access for HIV acquired during the conduct of these trials. We used outcomes from the consultations and inputs in South Africa (as well as existing norms) to inform the guidance that appears in that ethical guideline on the issue of treatment access for HIV infection (SA MRC, 2003).
From this series of professional experiences, I became very interested in the degree to which familiar ethical principles could be used to ground justifications for sponsor-investigators to ensure access to treatment. I partnered with a colleague with a background in philosophy (and other HAVEG members) to explore this issue, publishing a paper on it in early 2005 (Slack et al., 2005). The paper was subsequently rebutted (Schϋklenk & Ashcroft, 2008) and countered (Stobie & Slack, 2008; Stobie & Slack, 2010). This set of writing experiences lead me to believe that - while it was important to contribute to the normative debate – HAVEG did not have any empirical data on this issue and that empirical data might be helpful in strengthening approaches to this issue. At around this time, I was also a member of the African AIDS Vaccine Program’s Ethics Law and Human Rights Working Group, where in 2004 I had been involved in an questionnaire-based review of ethical complexities reported by RECs in Africa (Milford, Wassenaar & Slack, 2006), including the issue of access to treatment, therefore I assumed that the issue posed a challenge to review bodies, but did not know exactly how the substantive details might manifest.
Over this period, I had also been involved in attending several training workshops and consultations where this issue was discussed including a workshop convened the National Institutes of Health Department of Clinical Bioethics on 2003 and a consultation convened by WHO/UNAIDS in 2003 (WHO/UNAIDS, 2004) as well as a consultation convened by the Global Campaign for Microbicides in 2004 (GCM, 2005) and one convened by WHO/UNAIDS in 2007, where I acted as rapporteur (WHO/UNAIDS, 2007). I was sensitized to many of the theoretical complexities at these consultations as well as interacted with some of the leading writers on the issue including but not limited to Henry Richardson, Ruth Macklin, and Kate MacQueen. At many of these consultations the recommendation was emerging that sponsor- investigators certainly had some responsibilities with regard to HIV needs, and that it was not acceptable to do nothing, but these experiences impressed on me that the justification being
favoured (the ‘why’) strongly influenced perspectives about what needs should be attended to, what parties should be attended to, and what steps should be implemented (the ‘what’
‘who’ and ‘how’).
In 2009, as part of HAVEG, I was involved in securing a grant from the Wellcome Trust Biomedical Ethics Program to conduct an empirical exploration of ancillary care, as well as access to prevention modalities. The two-part nature of the exploration funded by the grant meant that I would be working closely with another researcher who was responsible for the exploration of prevention modalities, or so-called ‘standard of prevention’ activities related to HIV vaccine trials in South Africa. As a part of a review of studies (to secure the grant) I became aware that many conduct-type studies had been conducted to map the steps investigators were implementing to address medical needs in related studies, but that few studies had investigated in detail the viewpoints of stakeholders, and their perceived complexities but rather had tended to foreground practices, or actions or behaviours.
As part of the activities of the grant, I was involved in researching the reported conduct of key stakeholders in order to make comparisons with current ethical requirements (Slack, 2014). I was motivated to complement that exploration with an additional exploration that would illuminate in a more nuanced way the complexity of these stakeholder experiences. After the grant was awarded, I sought approval from the study sponsors to register for a PhD that would allow just this. This meant that my data collection, coding and analysis had a dual focus (to achieve the aims of the study grant as well as to achieve the ends of the PhD) and I had a ‘dual role’ (as a project researcher as well as a PhD student). In some instances, this dual focus impacted in a complicated way on my coding, as set out in the section on coding and analysis that follows later.
From my prior experiences, I was aware that people had different and varied views about the principles that best grounded care responsibilities, which impacted their understanding of who and what should be responded to. I was primed to search for accounts of why it was important to address such needs and expected to find such accounts and understandings, but I was not clear about the precise form these justifications would take. I was of the view that sponsor-investigators should take steps to address HIV needs (at the least to actively refer
people to reliable sources) and I expected to find these practice accounts for HIV, but I had fewer expectations about approaches for other needs. I also did not have a sense of the detailed micro-steps that could be implemented to help participants address their medical needs. I also anticipated that stakeholders would experience many challenges related to ancillary care, but was not sure of their precise manifestation.