Improving quality of preclinical academic research through auditing: A feasibility study

PLoS One. 2020 Oct 15;15(10):e0240719. doi: 10.1371/journal.pone.0240719. eCollection 2020.

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).

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biomedical Research / standards*
  • Feasibility Studies
  • Humans
  • Medical Audit / standards*
  • Neurology
  • Self-Assessment

Grant support

The Volkswagen Stiftung (Hannover, Germany) support the development of the PREMIER Quality System. The described audits in the manusscript are a Quality tool in that QM System. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.