LICENCIAS DE CAMBIO DE REGIMEN DE PROPIEDAD Y URBANIZACIÓN

All research involving human subjects needs to be reviewed and approved by a research ethics committee, a professional or a regulatory body (Yonas et al., 2013) to make sure it is in accordance with best practice and that risks, potential harms and consequences are carefully accounted for.

The proposal for the empirical studies concerning this thesis, which involved various forms of data collection – but did not require direct patient involvement nor the handling of any sort of human samples – was submitted to representatives of the research governance body of Leicester Royal Infirmary, the environment in which the study took place. The proposal was analysed by the departments of Clinical Audit, and Research and Innovation, and was classified under the ‘service evaluation’ category.

That classification was further confirmed with the use of an online tool designed to

137 support decision-making regarding research ethics procedures within the NHS⁴⁷. Not all research conducted within the UK health system requires NHS clearance, including most research classed as ‘service evaluation’. Thus, the UTI study was, in lieu,

submitted, approved and filed by the Research Office at Loughborough University, in conformity with University regulations and requirements⁴⁸.

3.6.2 Additional Relevant Measures

Obtaining informed consent is a standard, formal procedure that, rather than a one-off tool used prior to involvement in specific activities, must be handled as an ongoing process (Austin, 2015). Consent forms aim to clarify the intentions, risks and benefits of research, and to direct participants, using accessible language which avoids

unnecessary jargons and technical terms (Guttmacher et al., 2010). The process of obtaining an informed consent from human subjects taking part in research is,

furthermore, a mechanism to protect individuals from being ‘coerced, or persuaded, or induced into research “against their will”’, while ensuring ‘that their participation should be based on voluntarism, and in a full understanding of the implications of participation’ (Green & Thorogood, 2014).

An informed consent form was devised and distributed to stakeholders taking part in interviews, workshop and focus groups activities, all of which involved the recording of audio data. The forms were accompanied by an adult participant information sheet and consent was obtained prior to initiating the activities. In total, seventeen participants signed an informed consent form. Other activities in which participants input or feedback was incorporated to the data – such as meetings and group discussions via email and WhatsApp – did not require formal consent, according to NHS regulation as explained above.

Another form of ‘unofficial’ consent was sought at the beginning of data collection. The first two workshops of the study – Workshop 01: Shared Understanding and Workshop 2: Behavioural Challenges – involved the use of unpublished findings from a set of

47 The on-line tool is based on guidance developed by the Central Office for Research Ethics Committees (COREC) and amended by the National Research Ethics Service (NRES) of the Health Research Authority (HRA), with support of the Medical Research Council (MRC): http://hra-decisiontools.org.uk/ethics/

48 All relevant documents submitted for ethical approval – including the study proposal, the participant’s information sheet and, a template for the informed consent form – are included as appendices to this thesis.

138 interviews conducted with LRI staff, carried out by a group of researchers from both LRI and the University of Leicester⁴⁹. These findings were voluntarily shared by the researchers themselves, who have generously allowed the use of their data in the development of the present study and written authorisation was provided via email exchange between the parties. Participants in that activity were notified that the data used in the workshop had been gathered and previously analysed by a group of researchers outside of the current research team.

Safeguarding Participants’ Rights, Privacy and Anonymity

Most professional codes of ethical conduct share attributes around participants’

confidentiality and the protection of individual rights and safety, in addition to emphasising the importance of obtaining informed consent (Guttmacher et al., 2010).

Assuring participants’ anonymity is also an important procedure aimed at not revealing or making accessible personal information that could be linked to individuals taking part in the research process (Guttmacher et al., 2010).

Participants’ privacy and anonymity was ensured by securing the storage of both physical and digital data, which involved redacting personal information from

documents, encrypting data stored digitally, and using alias or numbers instead of real names.

Because of the participatory nature of this research, preliminary outcomes and results from the activities were constantly being shared amongst many stakeholders

throughout the study. Whenever written information or files containing materials produced by participants were shared, names and other identifying elements were excluded from the material to avoid potential cross-identification of the sources by participants themselves. Considering that during the activities of this study participants developed close work relationships with each other, these measures aimed to further improve confidentiality and privacy. Simultaneously, these practices directly

contributed to avoiding confrontation or animosity between participants with conflicting or opposing views. This aspect was critical since some participants had hierarchical relationships with each other and these relationships could be impacted if their positions had been openly revealed against their will or without their knowledge and consent.

49 This study and its importance to this thesis will be further discussed in section 4.1.2.

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Research Quality and Accurate, Trustworthy Representation

Good quality research that involves the participation of human subjects needs to pay attention to ‘professional standards’, legal or statutory requirements and ethical principles’ (Green & Thorogood, 2014). Principally, these attributes need to be observed as they relate to the protection of participants, as researchers acknowledge that their work is both affected by, and an agent of, social and political influence (Green

& Thorogood, 2014). Diverging from positivist views that proclaim research can (or should) be a value-free pursuit for an objective truth, most qualitative research assumes that scientific investigation is oriented by distinguished worldviews, and is inescapably charged with personal, professional and disciplinary preconceptions that should be made evident instead of being denied (Hignett, 2005). In accordance with that perspective, to avoid, minimise or mitigate manipulation and misrepresentation, researchers need to be attentive to how the perspectives of stakeholders are

incorporated and articulated in relation to (and sometimes against) the objectives of the research project.

It is of primary importance in participatory research to ensure opportunities for stakeholders to partake in the sense-making of both preliminary findings and resulting conclusions stemming from the research; as well as to provide input into the research design and evaluation processes (Guttmacher et al., 2010). It is necessary to bear in mind that participatory research stages and activities are often not entirely defined from the onset (Austin, 2015) and, thus, dialogue with participants needs to be sustained dynamically, as the contours of the research are continually (re)defined.

A sustained practice of running information past stakeholders has governed this research project from the onset all the way through data analysis and reporting of findings. Initially, when tailoring the project’s structure, research questions, objectives and methods for fieldwork, a number of core partners at LRI were consulted (most research and/or clinical staff). Their input and suggestions were influential in

determining the final proposal for the empirical data collection. Subsequently, across the entire duration of the study and including all activities, frequent participation was sought concerning sense-making and interpretation of data collected and the outcomes produced by participants. This on-going exchange was mainly via email (resulting in approximately 150 pages of recorded message exchanges, involving more than thirty different people) but also during in-person sessions when results were recapped during group discussions.

140 Of central concern throughout this exchange process was the notion of transparency in the sense that stakeholders were constantly made aware of the ways in which their engagement was being sought, and purpose throughout the course of the research (Austin, 2015).

Finally, to maintain upfront ethical conduct, researchers needed to make sure that the

‘voices’ highlighted by the research – whenever participants’ discourse is appropriated to support claims or positions – is faithful to what was actually said. This entailed demonstrating the circumstances in which statements were made. Likewise, it was important to assure the trustworthiness of quotes utilised via a sound process of transcription and acknowledgement of authorship (granted anonymity is guaranteed) whenever research material is presented, shared or published (Yonas et al., 2013).

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CHAPTER 04

Changing UTI Practice in the Emergency