CHAPTER FOUR RESULTS
4.1 RECIPROCATING, ENGAGING, BENEFITTING
‘…these people stand up and be counted…’
This master theme sets out the manner in which vaccine stakeholders made sense of researcher responsibilities to assist participants with their medical needs. It sets out how stakeholders framed obligations to help participants and how they characterized why ‘extra- scientific’ helping-based responses should be implemented for participants.
Firstly, stakeholders characterized reasons for helping as rooted in a response to participants’
contributions, especially in relation to HIV infection. Site-staff and network representatives saw participants as distinguishing themselves from other people, or from the general crowd, by making specific kinds of contributions. They saw participants as ‘stepping forward’ or
‘standing up’ - implying that many other persons hang back. These characterizations promote the idea that participants single themselves out for a certain kind of attention from researchers:
…people who seroconvert on a HIV prevention trial have basically said, ‘Ok, you know, I’m going to go on this regimen to see whether we can prevent HIV,’ and whether it’s a
microbicide or a vaccine or anything, you know, these people, you know, stand up and be counted. Much in the same way, we should make sure that if they do get HIV-infected that they have access to the best care that they can get in their region [p/HIV] [c4, site- staff, site B].
Site-staff and network representatives viewed participants as ‘bringing’, ‘giving’ or ‘putting in’
various things or making various contributions. Stakeholders did not share identical understandings of what has been contributed, and they variously characterized that participants bring their passion, time, effort, energy, commitment, and volunteerism.
Therefore, they saw participants as bringing valued, significant, non-trivial things to the table. As one site-staff representative put it:
…we’ve asked them to join the study and they’re really putting a lot of effort into vaccine trials. I don’t think I would be a good vaccine trial participant, they’re really putting a lot of effort and a lot of their time and energy to actually be a part of the trial that I think that from the site’s side it’s important that we try and make it as easy for them if they do become HIV infected and especially being there to support/ to be able support them [p/HIV] [c15, site-staff, site E].
Site staff and network representatives also held the view that participants take on many risks by agreeing to receive experimental HIV vaccines, including putting their bodies at risk by agreeing to take vaccine products. A key component of this view was that participants make the noteworthy and valuable contribution of willingness to assume risk.
Furthermore, these contributions were viewed as being made (in most instances) to science, to the research, or to the trial, or to the researchers. They perceived that it is the research(ers) that have solicited participants’ contributions, or requested participants to make these contributions – so it is to researchers that the participants bring their contributions. In fewer instances, they viewed the contributions as being made to a faceless group of future beneficiaries of the research (‘humanity’ as one interviewee put it). They characterized these contributions as unforced - they are ‘volunteered’, or willingly offered in response to requests.
These contributions were seen as being made in the face of highly uncertain personal benefit from the experimental HIV vaccine itself.
Site-staff and network representatives and even some REC members rooted responsibilities to participants with HIV needs in how participants ‘take it on the chin’ for the research(ers).
They saw that participants are owed something in return because participants make contributions - largely on the invitation of researchers. Responsibilities were viewed as responses to offerings received from participants. Site-staff, network representatives and RECs all invoked this central idea that participants contribute some valued thing and that necessitates that researchers give some kind of ‘return’, or make some kind of helping response. As one network representative stated:
…..the very nature of our clinical trials is trying to identify individuals who are at highest risk for acquiring this disease who then have you know sort of given their bodies to the clinical trial for an experiment that we don’t know will work or not, you know the inherent equipoise that we’re in and there being a willingness to do so for more the benefit of society and humanity than for individual bodies and I understand not all individuals are so/ are driven by…what’s the word? not philanthropic but are not necessarily driven by these humanitarian impulses. There’s an element to it I mean for everyone on some level and there’s an obligation to do the most we can for those who do become infected in these clinical trials and especially with the advances that we have, it’s really a payback you know that is a real, at the same time, obligation and honour to provide [p/HIV] [c14, network].
This first sub-theme (‘reciprocating for participants’ contributions’) captures the viewpoint that researchers are relating to participants in a way that is quite specific – researchers make an invitation, participants respond to the call, participants make significant contributions, and researchers need to respond appropriately by helping them, especially if they acquire HIV.
The helping is understood here – in this first sub-theme – as a kind of giving back. This conception of the relationship was most frequently invoked by stakeholder representatives.
Secondly, stakeholders rooted responsibilities to help participants with their HIV needs in respect for an on-going relationship with participants (‘staying involved with participants’).
They saw that the relationship should not be terminated merely because participants acquire HIV, that HIV-acquisition should not signal the end of the relationship, and they invoked images of not washing hands of participants, and of ‘not cutting off’, ‘not dumping’ or ‘not dropping’ participants. These images characterized not helping participants as a kind of ‘using and abandoning’. In similarity with the sub-theme above, reasons for helping were linked to a relationship with participants, but in contrast to the sub-theme above, reasons for helping were not linked to being in a reciprocal relationship with participants. As one CAB representative stated:
I mean, I think that is a success to say that (the site) has provided/ has planned for the people that ‘ok if you come to us, you’re not good just because you come with your status that says your negative, you’re not only good because you come to us with a negative status and then once something has happened to you, you seroconvert and then we like drop you like that’. No, they have a plan, where they counsel the person, the put the person in (follow-on study) and if that person comes to a state where they need treatment, and then they go to (X) which is the treatment wing. So ya, I believe that is care enough for the people. Cause if the site was only focusing on the negative people, then once you positive then you not their business, that was going to be painful
… [p/HIV] [z3, CAB, site B].
For these stakeholders there seemed to be something unacceptable about valuing participants only for their HIV-negative status, and they saw helping participants with their HIV infection as signaling awareness of the whole person involved in an encounter with researchers, as evidenced by the following quote:
…let the human being be treated holistically. You can’t zoom into a person to say ‘look here, I'm only interested in preventing HIV and AIDS’. You can’t divide somebody into segments, ya. So this is why I'm saying that it’s important to look at this person holistically. I think it’s only ethical and it’s only Ubuntu to say ‘you are a human being and therefore I'm interested in you. In as much as we are agreeing that you sign informed consent and agreeing that you are only doing HIV preventive trial participation, but still, I'm interested in your wellbeing …’ [p/HIV] [z3, CAB, site B].
Thirdly, site-staff viewed their responsibilities to help participants with their medical needs, by addressing them in a particular way such as providing onsite treatment, as rooted in benefitting or serving participants. They understood that if they adopted a certain approach (or implemented a certain response) they were conferring benefits on participants. For example, they characterized the onsite provision of medication for STIs or even other ailments as protecting participants from time-wasting or stigmatizing attitudes at off-site service-points. The strategy of onsite provision of hormonal contraception was viewed as benefitting participants by protecting them from inadequate counselling, poor toxicity tracking and time-wasting at public-sector referral sites (even while the response of ensuring contraception per se was clearly seen as rooted in safety). In this sub-theme, stakeholders did not explicitly anchor responsibilities in the reciprocal exchange, or in a non-using relationship, but they did see that some helping steps should be taken because participants would be assisted with their busy lives, their many non-trivial non-research based demands and their real service needs (‘benefitting and serving participants’). Interestingly, there were few characterizations that unequivocally grounded STI treatment in a HIV-prevention rationale.
Fourthly, and infrequently, site-staff acting as study clinicians anchored responsibilities to help participants with their medical needs in the clinician-patient relationship. They saw that participants should be helped because clinical staff have specialized training in the diagnosis and management of patients’ clinical conditions and should respond appropriately using their skills to address participants’ health problems (‘caring for patients’). As one site-staff member stated:
I think as a nurse or as a doctor you have been trained to screen people for medical conditions and definitely you should refer and if this participant is not already receiving care you should, it is your ethical duty to refer this patient to the appropriate place and make sure that they access care from somewhere (…) the fact that you did the blood pressure and you know, the mere fact that you did the blood pressure you now have an obligation to act on that you know. If you didn’t, if you weren’t doing the blood pressure its fine and you didn’t pick it up and you didn’t know the person was hypertensive but the fact that you did it means that you thereafter have an obligation to act on that
elevated blood pressure or at least ask them to come back in a week to re-check the blood pressure something. You have to do something… [p/other] [c2, site-staff, site A].
In summary, the findings captured under this master theme indicate that stakeholders made sense of researcher responsibilities to help participants in very particular ways. (The helping- based responses that researchers actually implemented are outlined in the next theme as well as the final theme). They tended to root responsibilities to help in accounts of the relationships that researchers establish with participants (‘reciprocating for participants’
contributions’, ‘staying involved with participants’, ‘benefitting and serving participants’, and
‘responding to patients’). More specifically, they invoked relationship-centered accounts of these responsibilities. They saw that researchers should help participants with their HIV needs because it represented a ‘return’ for participants’ significant contributions. They saw that researchers should help participants with their HIV and non-HIV needs because it represented relating respectfully in a non-using and non-abandoning way. They recognized providing services as way to add value to participants’ lives. They also (infrequently) volunteered the understanding that researchers should help participants because they were clinicians faced with patients. That is, in conceptualizing the duties of researchers to help participants with their medical needs, several relationship-centered ideas appeared to be at work – the first was that researchers were in a reciprocal relationship with participants, the second was that researchers were in a respectful relationship with participants, the third was that researchers were able to serve participants in seemingly modest but significant ways, and the last (and least frequent) was that select research staff were in a clinical relationship with patients.