Abstract
How much can we rely on whether what was reported in a study was actually done? Systematic and independent examination of records, documents and processes through audits are a central element of quality management systems. In the context of current concerns about the robustness and reproducibility of experimental biomedical research audits have been suggested as a remedy a number of times. However, audits are resource intense and time consuming, and due to their very nature may be perceived as inquisition. Consequently, there is very little experience or literature on auditing and assessments in the complex preclinical biomedical research environment. To gain some insight into which audit approaches might best suit biomedical research in academia, in this study we have applied a number of them in a typical academic neuroscience environment consisting of twelve research groups with about 100 researchers, students and technicians, utilizing the full gamut of state-of-the-art methodology. Several types of assessments and internal as well as external audits (including the novel format of a peer audit) were systematically explored by a team of quality management specialists. An experimental design template was developed (and is provided here) that takes into account and mitigates difficulties, risks and systematic errors that may occur during the course of a study. All audits were performed according to a pre-defined workflow developed by us. Outcomes were assessed qualitatively. We asked for feedback from participating employees in every final discussion of an audit and documented this in the audit reports. Based on these reports follow-up audits were improved. We conclude that several realistic options for auditing exist which have the potential to improve preclinical biomedical research in academia, and have listed specific recommendations regarding their benefits and provided practical resources for their implementation (e.g. study design and audit templates, audit workflow).
Highlights
We will first review which forms of audits we considered suitable for academic preclinical biomedical research and were tested at our department over a time period of several years
Audits were considered successful if they were accepted by the employees, conducted in a clear and non-aversive language, and if the scope and objectives of the audit were clearly defined and if the measures resulting from the audits proved to be effective
Acceptance we defined as agreement of the employees with the objective, focus and manner in which the audit was carried out
Summary
An audit is a systematic and independent examination of records, documents and processes of an organization (e.g. university, department, research group) to ensure compliance to pre-specified requirements or criteria. An assessment is a demonstration that specified requirements relating to a product, process, system, person or body are fulfilled as defined in ISO 17000 [23]. A member of another working group, and expert on the described method, examined and questioned the specific implementation, discussed the results and made suggestions for improvement if necessary. In this way, SOPs were checked for deviations or gaps. Processes: A specially developed, detailed experimental/ project-planning tool, available as a template in the electronic laboratory notebook, was tested and validated on two projects
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