Case study 3: Quality management plan

Background: Embedding quality management into your IR proposal is not an optional step. Quality management is essential to ensuring research meets or exceeds scientific, ethical and regulatory standards. Since quality assurance is integral to all research activities, the quality management plan of the proposal should explicitly outline how the research team will ensure consistent quality of the research during the project life cycle. The table illustrates the quality control measures taken by a research team that assessed the knowledge and attitudes of key community members towards tuberculosis in Bangladesh. The measures adopted to selection of safeguard scientific integrity ensured appropriate study designs, sample size, sampling strategy and selection of study participants. To ensure that tools were standardized, specific elements were pre-tested and essential adjustments were made before actual data collection. Similarly, to minimize errors in the data collection processes, all data collectors and supervisors were briefed about the scope of the project and were trained in the use of the data collection tools. Furthermore, all data collectors were assigned supervisors who checked for consistency and completeness of the data collected. Focus group discussions (FGDs) and key informant interviews (KII) were recorded for reference. The ethical concerns of research participants were taken into consideration through the translation of the study tools into Bengali (the local language), seeking informed consent and observing confidentiality and privacy. Ethical clearance was sought from the relevant ethical review committee.

Table. Data quality management measures
Study phase Variable Quality control measure
Design Study design Mixed methods enabled the capture of both quantitative and qualitative aspects
Sample size Scientifically derived (i.e. based on prevalence, power of study, degree of error, design effect)
Study area Randomly selected
Sampling of participants Participants were selected through purposive sampling and convenient sampling of key informants
Study tools Structured questionnaires for quantitative methods
FGD guide and KI guide for qualitative methods
Data collection tools translated into Bengali
Ethical concerns Sought ethical approval from the Ethical Review Committee of James P. Grant School of Public Health
Pilot testing of the tools to ensure they were accurate and culturally sensitive
Data collection Data quality Training of data collectors
Field protocol with all the instructions, including skipping and probing
Supervision of the data collectors
Notes were taken during FGDs and IDIs
Recording of interviews and discussions done to avoid information loss
Ethical concerns Informed verbal consent, observation of confidentiality and privacy
Data Management Qualitative data Data was cleansed

Lessons: Quality processes should start right from the study design stage and continue throughout the project life cycle. These should be succinctly described and justified in every research proposal.

Source: Paul S. et al. Knowledge and attitude of key community members towards tuberculosis: mixed method study from BRAC TB control areas in Bangladesh. BMC public health. 2015; 15(1):1.