5.2.1.1 Overview
Phase One: data were collected through observation of patient recruitment for MGE research. The intention was to view individuals’ behaviours in their natural settings in order to determine the extent to which there was adherence to the current Saudi bioethics guidelines governing recruitment.
Phase Two: data were collected through semi-structured interviews with individuals who had recently donated blood for MGE research. The aim of the interviews was to explore how the interviewees experienced donation and recruitment for MGE research and the extent to which they understood what they were agreeing to in their consent interview.
Phase Three: data were collected using focus groups comprised of researchers (group 1) and bioethics policy-makers (group 2). The intention was to explore how the participants thought MGE research in SA was and should be governed, and to gain participants’ reactions to the practices and experiences encountered in phases one and two.
Having provided an overview of the methods chosen for data collection I will now describe and justify each phase in detail.
124 5.2.2 Phase One – Observations
A useful and pragmatic definition of observation as a research method is given by Marshall and Rossman (1989) as cited in Kawulich (2005): ‘the systematic description of events, behaviors, and artifacts in the social setting chosen for study’
(p79). Observation is associated with ethnography, as it enables ethnographers to observe phenomena in their natural context using their own five senses to provide what can be described as ‘written photograph[s]’ (Erlandson, 1993; Kawulich, 2005).
However, ‘it is important note that the two [participant observation and ethnography]
are not synonymous’ (Ives & Damery, 2014, p109). In other words, ethnography is not only participant observation and, most importantly, not every participant observation is ethnography (Ives & Damery, 2014).
There are two main methods of observation: direct observation (Kawulich);
(Bernard, 2011; Hull et al., 2001) and participant observation (when the researcher assumes an ‘insider’ role and becomes part of the observed setup) (Hull et al., 2001;
Kawulich, 2005). The main goal of observation in this phase was to directly view both those who were giving consent and those who were receiving it in MGE research recruiting sessions. Observation was used according to Mays & Pope (1995) account namely as ‘it can help to overcome the discrepancy between what people say and what they actually do.’ (p3) Passive observation, or what Bernard (2011) and Hull et al. (2001) called direct observation was chosen because of the risk of going
‘native’ which is described by Mays & Pope (1995) as ‘becoming so immersed in the group culture that the research agenda is lost, or that it becomes extremely difficult or emotionally draining to exit the field and conclude the data collection.’ (p3).
125 Observation enables non-verbal communication, including how the participants acted in the study situation, as well as how the recruiting process time was spent (Schmuck, 1997) to be recorded. Observation enables the uncovering the tacit aspects of values or culture that remain out of our awareness (DeWalt and DeWalt, 2010).
I was a passive observer and did not participate in the observed consenting procedure in any way (Robson, 2002). The observations were not video or audio recorded, but extensive field notes were taken. No identifying information was recorded in the field notes. Prior to the observations, I read the observed organisations specific clinical polices related to research consent interviews. This was to determine whether these conformed with the NCBE guidelines. This also enabled me to observe the extent to which the practices I observed conformed to the organisations own guidelines.
I, as a researcher, was aware of the challenges around observation as a qualitative research methodology. The most important two challenges were the observer effect and the robustness of the data collection. Observer effect usually refers the potential for changes in people’s behaviours when they are under the impression that they are being observed. To overcome this challenge, or at least minimise its effect, it is usually advisable to spend the time in the natural setting (i.e.
not to be perceived as a stranger by observed participants) (Hull et al., 2001).
I planned to minimise the observer effect by trying to habituate myself as much as possible with the research sites and clinics. However, I did not dismiss the
126 possibility of the observer effect therefore I planned to look sceptically at the data as it could be the best practice that would echo the regulation in details.
I resisted taking notes during the observed sessions in order not to disturb the normal flow of events in the recruitment. All the field notes were recorded immediately after the observed sessions ended. In order to ensure the robustness of the data, I planned to be as systemic as possible, i.e. by conducting each observation using the same routine and, immediately after each session, by writing up all the details that I could remember while they was still vivid in my memory (see Appendix 1: example of the field notes).
5.2.2.1 Recruitment and ethical considerations
The original intention of this phase was to observe both prospective donors and researchers in recruiting sessions for potential blood donors for MGE research in three major hospitals in Saudi Arabia. Although these hospitals were all in Riyadh, they can be regarded as representative of the whole kingdom because they all receive patients and referrals from across the country.
A poster (Appendix 2) was displayed in staff areas informing staff of my name, contact details, and the purpose of the study. When a consent interview was booked, relevant staff members were approached in person and in a private space, reminded about the study and asked if they were willing to be observed. All of the approached staff members verbally consented to participate. A similar poster (Appendix 3, translated into Arabic) was displayed in patient waiting areas. Patients were asked for permission for me to observe the researchers gaining their consent by the
127 researchers themselves, using a process of verbal consent as they entered the consultation room (Appendix 4) after checking that they had read the poster (Appendix 3), understood it, and had no objections to its content. I decided not gain the patients’ consent myself for the following reasons:
It was important to ensure that the observed researchers had the opportunity
to veto an observation if the patients were unwilling to agree. My presence may have made this more difficult as it was socially more comfortable not to invite me into the room than it would have been to ask me to leave.
Although the patients were part of the observation, the researchers were the
target participants as they were the ones responsible for adhering to the NCBE guidelines.
The poster that was displayed, before the observations, was designed to draw
the attention of the research team (who were observed) to verbally consent the patient.
I wanted to observe the process passively with no interaction whatsoever with
the patient during the recruiting process – gaining consent myself would have inserted me into the interaction and potentially influenced behaviour, which would be detrimental to the study.
Asking patients to provide written consent had the potential to confuse
patients about what they were consenting to (i.e. to my study and blood donation for MGE research). Accordingly, it seemed more ethical to downplay my research so as not to distract their attention away from the more serious decision about participating in the MGE research.
128 The researcher-participant was given the opportunity to withdraw within 48 hours of being observed.
5.2.2.2 Inclusion and Exclusion criteria
All consent interviews were planned to take place in the three-targeted hospitals that were recruiting adult blood donors for MGE research during the period from February 2013 to May 2013. As the age of consenting in Saudi Arabia is 18, being an adult was defined in this project as any person who is 18 years old or older.
Mental capacity was assumed when a participant appeared able to rationalise his or her decision to participate. All researchers were assumed to have mental capacity by virtue of their job. Those who did not wish to have their interview observed (researcher or patient) were excluded.
5.2.2.3 Sampling
Convenience sampling technique was employed. Convenience sampling was deemed to be the most suitable technique as it helps facilitate recruitment in a manner that matches the overall timeframe of the project. Observations were planned at three different institutes, all of which have active, busy research departments and multiple genetics studies involving international collaborators.
129 TABLE 5-1:THE THREE RESEARCH SITES
First hospital Second hospital Third Hospital Specialty Ophthalmic–specialised General-specialised General-specialised Reference Ministry of Health (MOH) Military hospital 5 The Royal Court
Capacity 400 beds 600 beds 500 beds
5.2.3 Phase Two – Interviews with patients who had been invited to donate