RT Journal Article
SR Electronic
T1 International health research monitoring: exploring a scientific and a cooperative approach using participatory action research
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e004104
DO 10.1136/bmjopen-2013-004104
VO 4
IS 2
A1 Chantler, Tracey
A1 Cheah, Phaik Yeong
A1 Miiro, George
A1 Hantrakum, Viriya
A1 Nanvubya, Annet
A1 Ayuo, Elizabeth
A1 Kivaya, Esther
A1 Kidola, Jeremiah
A1 Kaleebu, Pontiano
A1 Parker, Michael
A1 Njuguna, Patricia
A1 Ashley, Elizabeth
A1 Guerin, Philippe J
A1 Lang, Trudie
YR 2014
UL http://bmjopen.bmj.com/content/4/2/e004104.abstract
AB Objectives To evaluate and determine the value of monitoring models developed by the Mahidol Oxford Tropical Research Unit and the East African Consortium for Clinical Research, consider how this can be measured and explore monitors’ and investigators’ experiences of and views about the nature, purpose and practice of monitoring. Research design A case study approach was used within the context of participatory action research because one of the aims was to guide and improve practice. 34 interviews, five focus groups and observations of monitoring practice were conducted. Setting and participants Fieldwork occurred in the places where the monitoring models are coordinated and applied in Thailand, Cambodia, Uganda and Kenya. Participants included those coordinating the monitoring schemes, monitors, senior investigators and research staff. Analysis Transcribed textual data from field notes, interviews and focus groups was imported into a qualitative data software program (NVIVO V. 10) and analysed inductively and thematically by a qualitative researcher. The initial coding framework was reviewed internally and two main categories emerged from the subsequent interrogation of the data. Results The categories that were identified related to the conceptual framing and nature of monitoring, and the practice of monitoring, including relational factors. Particular emphasis was given to the value of a scientific and cooperative style of monitoring as a means of enhancing data quality, trust and transparency. In terms of practice the primary purpose of monitoring was defined as improving the conduct of health research and increasing the capacity of researchers and trial sites. Conclusions The models studied utilise internal and network wide expertise to improve the ethics and quality of clinical research. They demonstrate how monitoring can be a scientific and constructive exercise rather than a threatening process. The value of cooperative relations needs to be given more emphasis in monitoring activities, which seek to ensure that research protects human rights and produces reliable data.