Semi-structured interviews were conducted with representatives of the coordinating network as well as Research Ethics Committees, Community Advisory Boards and research staff at five sites in the country implementing two HIV vaccine trial protocols. These master themes, and sub-themes, are discussed in terms of the assisted care literature.
CHAPTER ONE INTRODUCTION
BACKGROUND
The debate over researchers' additional care responsibilities in HIV vaccine trials has had many facets. Empirical data on additional care practices have been systematically collected for non-vaccine prevention trials (cf. Heise, Shapiro & West Slevin, 2008; MacQueen & May, 2008), but systematic exploration in HIV vaccine trials is limited (Macklin, 2009).
STUDY AIMS AND APPROACH
STUDY OUTLINE
CHAPTER TWO LITERATURE REVIEW
INTRODUCTION
- THE HIV EPIDEMIC AND RESPONSES INTERNATIONALLY
- THE HIV EPIDEMIC AND RESPONSES IN SOUTH AFRICA
- HEALTH RESEARCH WITH HUMAN PARTICIPANTS
- HEALTH RESEARCH WITH HUMAN PARTICIPANTS IN SOUTH AFRICA
South Africa bears a huge burden of HIV infection, even though the country has only a fraction of the world's population (Abdool Karim et al., 2009). Age-disparate partnerships and multiple simultaneous and sequential sexual relationships are among the main drivers behind the South African epidemic (Abdool Karim et al., 2009).
HIV VACCINE TRIALS
- AIMS, PHASES AND STAKEHOLDERS IN HIV VACCINE TRIALS
- HIV VACCINE TRIALS IN SOUTH AFRICA
In South Africa, eight trials of the HIV vaccine have been completed since 2003, and four more trials are ongoing (Emily Donaldson, personal communication, August 13, 2014). South Africa has also developed special guidelines for HIV vaccine trials (SA MRC, 2003) by adapting international ethical guidelines on the subject (UNAIDS, 2000b).
THE DEBATE ABOUT CARE IN HIV VACCINE TRIALS
- INTRODUCTION
- STANDARDS OF CARE
- ETHICAL PRINCIPLES
- MODELS OF ANCILLARY CARE
- THE PARTIAL ENTRUSTMENT ACCOUNT OF ANCILLARY CARE
- THE WHOLE PERSON ACCOUNT OF ANCILLARY CARE
- THE FOUR P’S ACCOUNT OF ANCILLARY CARE
- COMMUNITY ENGAGEMENT
- SUMMARY OF THE ACCESS TO CARE DEBATE
It was argued that this special responsibility is at the heart of researchers' ancillary care obligations (ibid). It has been argued that the partial trust account of ancillary care responsibilities is the most systematic account yet proposed (Dickert & Wendler, 2009).
RECOMMENDATIONS IN ETHICAL GUIDELINES
- GUIDANCE NOT SPECIFIC TO SOUTH AFRICAN HIV VACCINE TRIALS
- GUIDANCE SPECIFIC TO SOUTH AFRICAN HIV VACCINE TRIALS
- GUIDELINE RECOMMENDATIONS FOR PARTICIPANTS
- GUIDELINE RECOMMENDATIONS FOR NON-PARTICIPANTS
- GUIDELINE RECOMMENDATIONS FOR ENGAGEMENT
- SUMMARY OF ETHICAL GUIDELINES
UNAIDS/WHO (2007) recommends that research sponsors work with governments to strengthen HIV services to ensure the highest possible level of service and that there should be agreements between partners on care (although they argue that the local health system of care primarily responsible for providing care services). All ethical guidelines agree that stakeholders (including community representatives) should be involved in care decisions.
PRIOR EMPIRICAL EXPLORATIONS OF CARE
- SUMMARY OF EMPIRICAL EXPLORATIONS
They found that most sites used a combination of direct care (on-site insurance) and indirect care (referrals) to address participants' needs. The study found that many researchers felt called to provide ancillary care (not required to make the study scientifically valid, ensure safety, or remedy harm) (Philpott et al., 2010) and many sites implemented responses to help address the care needs of participants even. when this did not form any part of the research protocol. It was argued that sponsors should develop policies that facilitate the provision of supportive care to participants (ibid).
SUMMARY OF THE LITERATURE REVIEW
To date, only one such study has been conducted for HIV vaccine trials (Ngongo et al., 2012). Additionally, many of these studies assessed the degree to which practices met ethical guidelines, and when discrepancies were identified, a number of useful and insightful recommendations were made to improve practices to bring practices more in line with ethical guidelines (Heise et al., 2008 ). Other studies have evaluated practices and where complexity has been reported by stakeholders, these authors have made many useful recommendations to improve practices to address complexity (MacQueen et al., 2008).
CHAPTER THREE
STUDY AIMS AND METHODOLOGY
STUDY AIMS
STUDY APPROACH
- A QUALITATIVE STUDY
- AN INTERPRETIVIST FRAMEWORK
(2002) stated that approaching problems from an interpretivist perspective means taking seriously the subjective insights of individuals and linking them to their actions and potential impact. Terre Blanche and Durrheim (2006) noted that the interpretivist perspective is most appropriate when the reality to be studied is people's experiences, when an attempt is made to explore and explain the meanings behind actions, and the researcher is concerned about the meanings that people attach to their actions. experiences. This study centrally focused on a detailed exploration of stakeholder perspectives and actions in the context of HIV vaccine trials. Therefore, this seemed a useful perspective to situate the research.
STUDY METHODOLOGY
- BACKGROUND AND REFLEXIVITY
- PREPARING THE GROUND AND ADDRESSING ETHICAL COMPONENTS
- DEVELOPING A SAMPLING STRATEGY FOR INTERVIEWEES
- ACCESSING INTERVIEWEES
- DESIGNING SEMI-STRUCTURED INTERVIEW SCHEDULE
- ENSURING INFORMED CONSENT
- CONDUCTING INTERVIEWS
- SAMPLE CHARACTERISTICS
- CODING AND ANALYSIS
Interviewees who had direct experience with the issue of adjunctive care in HIV vaccine trials were selected as they would be able to contribute their personal stories and subjective experiences of adjunctive care (cf. Smith & Osborn, 2008). There were questions about the potential impact of the study (representing an occasional misunderstanding of this study as a form of audit to determine compliance with ethical requirements). The researcher must provide a compelling account of the nature and quality of the participants' experience with the phenomenon under investigation (Willig, 2008).
STUDY QUALITY
- INCLUDING A REFLEXIVE ACCOUNT
- MAKING USE OF TRIANGULATION
- MAKING USE OF MORE THAN ONE RESEARCHER
- LEAVING AN AUDIT TRAIL
- AIMING FOR A RICH DETAILED ACCOUNT
- INCLUDING VERBATIM EXTRACTS
- LOOKING FOR DIS-CONFIRMATORY EVIDENCE
- SOLICITING MEMBER-REFLECTIONS
- CONSIDERING IMPLICATIONS BEYOND THE SAMPLE
It is recommended that the researcher provide some interpretation of what it means for participants to have the concerns they do (Reid et al., 2005). They should disclose their education, previous personal and professional experiences (Malterud, 2001), occupation (Tong et al., 2007) and relationships with participants (ibid). It is also argued that the researcher can discuss aspects of the story not only with the original informants, but also with representatives similar to them (Elliot et al., 1999).
STUDY LIMITATIONS
The previous section describes the methodology followed in some detail and sets out sample characteristics to help readers judge the account's ability to generate responses in other contexts (Kelly, 2006c), so that the results are seen as merely self-referential (Tredoux & Smith, 2006 ). Qualitative researchers may also consider theoretical generalizability, where connections are made between the study's findings and claims in the existing literature. In the results section of the thesis - which follows here - however, efforts are made to accommodate variations and at the same time illuminate what is shared (Collins & . Nicolson, 2002; Reid et al., 2005).
CHAPTER FOUR RESULTS
RECIPROCATING, ENGAGING, BENEFITTING
Second, stakeholders rooted responsibility for helping participants with their HIV needs in respect of an ongoing relationship with participants ('getting involved with participants'). They tended to anchor responsibility for helping in accounts of the relationships that researchers establish with participants ('reciprocating to participants'. They saw researchers as having to help participants with their HIV needs because this represented a 'return' for the significant contributions of the participants.
RECONCILING
In some cases, site staff felt that the steps they were taking for science actually had certain important co-benefits for participants ('understanding that steps for science also help'). Site staff also reported that they have taken steps to address participants' STD, contraceptive, and pregnancy needs, as well as more common conditions. That is, these findings show that researchers are taking many steps to meet participants' needs, which are not only intended to further the scientific goals of the study nor to keep participants safe; these are helpful practices.
PRIVILEGING
Some site staff felt that participants deserve something from researchers that citizens do not, but they seemed uneasy about how much special treatment participants should receive. Some site staff and CAB representatives were concerned that ensuring special treatment for participants could result in citizens being too willing to 'transition' to become participants. In terms of STD needs, site staff at most sites recognized the benefits of on-site treatment for participants (less time wasted and less stigmatizing attitudes than public sector settings).
LINE-DRAWING
In terms of addressing needs, site staff and network representatives saw themselves as being oriented by a central 'mandate', 'work; 'business', 'purpose' or 'mission', characterized as. Furthermore, site staff and network representatives used the notion of potential harm to the overall research mission to help them decide whether certain aid-based responses were reasonable. They understood costing the research initiative too much as an important way to set limits.
PARTNERING
In terms of relationships between site staff and local service providers, site staff reported engaging local providers in a range of practices aimed at addressing participants' care needs. In terms of relationships between site staff and the network, network representatives reported a range of practices for engaging site representatives in a relationship that addressed participant concerns. In terms of relationships between site staff and CABs, site staff and network representatives reported a range of practices for involving CAB representatives in care.
SUMMARY OF RESULTS
In summary, the findings reported under this key theme show that many stakeholders recognized that it was essential that different role players were involved in the care of participants, and that no single stakeholder would be able to address the needs of all participants on their own. to provide. These findings show that the relationships were mainly seen as partnerships, with the partner's contribution generally strongly recognised, as well as their capabilities and commitment. The findings (under 'Partnering') show that many stakeholders felt it was essential to involve different role players to secure care for participants, and that no single stakeholder could meet the needs of all participants alone.
CHAPTER FIVE DISCUSSION
RECIPROCATING, ENGAGING, BENEFITTING
He argued that recognition of the importance of participants' contributions is relatively poorly developed in research ethics. This suggests that there may be many ways to respond to participants' contributions (e.g. by giving them post-trial access to an intervention that has proven effective in the trial) and that reciprocity does not necessarily have to take the form of helping of participants with their medical needs. Another subtheme (“Staying Engaged with Participants”) stated that vaccine stakeholders volunteered the understanding that researchers should assist participants with their medical needs because this amounts to respectfully interacting with them in a non-using manner and an unwavering manner .
RECONCILING
Miller et al., 2008) or the middle path (Dickert et al., 2007), which combines respect for the scientific endeavor with concern for participants. This is worth noting because it has been argued that it is problematic for researchers to view research from a purely therapeutic perspective (Litton, 2006; Miller et al., 1998). They appeared to recognize that therapeutic benefits may arise from research procedures as part of the research context, but not as the primary purpose of the research (Miller et al., 1998).
PRIVILEGING
Participants' understanding – including of potential benefits – should be promoted by providing them with appropriate written material (Woodsong & Abdool Karim, 2005) and by regular oral discussions with site staff (cf. the results here suggest that relative silence about safety benefits may be linked to concerns about the impact of incentives on participants' decision-making.Site staff also implemented different strategies to meet participants' needs, which indicated that participants at some sites were likely to be privileged over participants at other sites (e.g., on-site treatment for STIs or other conditions, preventing time wastage, whereas other sites did not; and one site referred participants to private practitioners for some general ailments, whereas no other site did; and sites referred to off-site facilities of varying quality ).
LINE-DRAWING
Although some ethical commentators question the relevance of the connection of participants' needs to the research question when making decisions about additional care (Dicker & Wendler, 2009), these findings suggest that these stakeholders see this too. Many commentators on supportive care refer to the so-called costs of supportive care measures (Brownsword, 2007; Merritt, 2011; Richardson, 2007). This suggests that stakeholders might embrace narratives of supportive care, requiring them to move beyond simple solutions to more demanding responses – and both partial entrustment and whole person accounts would fit here (as would others).
PARTNERING
- SITE-STAFF AND PARTICIPANT INTERACTIONS
- SITE-STAFF AND SERVICE-PROVIDER INTERACTIONS
- SITE-STAFF AND NETWORK INTERACTIONS
- SITE-STAFF AND COMMUNITY REPRESENTATIVE INTERACTIONS
- SITE-STAFF AND REC INTERACTIONS
This suggests that stakeholders do not expect researchers to shoulder the entire burden of supportive care for participants. Proponents of palliative care have alluded to the role of the community in providing palliative care. These data suggest that efforts to engage CABs to improve supportive care decision-making and implementation should be sustained and even intensified (Slack, 2014).
