The University of Bristol (United Kingdom) has devised a novel a quality assurance framework for life sciences which spans every stage of the research process.
The “Reproducibility by Design” programme incorporates the concept of “Quality by Design”, a key principle of pharmaceutical research and development. Quality by Design is an approach based on gaining a deep understanding of a process where quality is critical to the output and is intrinsically linked to quality risk management and the application of controls in a risk-proportionate manner.
The University of Bristol’s Reproducibility by Design framework applies a systematic approach to the design, conduct, analysis, publication and retention of research.
It has basic components which underpin all aspects of research and are common to the majority of life science disciplines, such as data management planning and bias minimisation. These are supported by more detailed discipline-specific guidance, training and tools.
To facilitate ongoing improvement processes, the design is modular, allowing for the evaluation and enhancement of content as necessary.
Three key principles of the framework
Research data should conform to the high possible standards of data integrity.
Quality by Design principles will be applied to ensure that research is designed to the highest possible standard, incorporating open science principles from the outset wherever possible.
Quality risk management will be applied proportionately to identify and minimise risks to the integrity of data, the ethical conduct of research and to participants and the environment.
To enable continuous improvement processes to be applied to ensure that the content can be evaluated and improved as needed.