"Appendix 1: Research methods--steps, techniques, and tools" [2020] ELECD 285; in Dove, S. Edward (ed), "Regulatory Stewardship of Health Research" (Edward Elgar Publishing, 2020) 189

Book Title: Regulatory Stewardship of Health Research

Editor(s): Dove, S. Edward

Publisher: Edward Elgar Publishing

Section Title: Appendix 1: Research methods—steps, techniques, and tools

Number of pages: 14

Extract:

Appendix 1: Research methods--steps,
techniques, and tools
In this appendix, I describe the research methods undertaken for my
empirical work and which define an anthropology of regulation, includ-
ing the justification for undertaking a `research trinity' of document
analysis, semi-structured interviews, and naturalistic observation.
Specifically, I link anthropology of regulation methodology with its
methods by discussing procedural aspects such as recruitment strategy,
interview topic design, data analysis, ethical considerations, and potential
limitations to my methods.

Data Sources, Types, and Forms

As regards the first arm of the research trinity, I undertook a literature
review that centred on qualitative document analysis of legal rules and
academic and grey literature from different disciplinary fields--primarily
law, anthropology, sociology, and biomedical science--as well as `human
subjects' research regulations. These texts were examined both for
substance and context through thematic analysis. This document analysis
was coupled with obtaining primary data in word and visual form
(through interviews and observations) from individuals and groups in
natural and semi-natural settings, as I explain below.
I observed REC meetings to gather data on actual behaviours and
practices and develop a detailed description of how RECs operate and
make decisions. By observing RECs, I aimed to witness what members
of these committees do in their natural settings.1 This meant that I
observed not only REC members, but also a fluctuating array of other
actors that form part of the ethics review system, for example, REC
Managers, REC Assistants, investigators, patient advocates, and others.
...