Scientific Integrity in Biomedical Research: a European Perspective

The issues of research integrity and misconduct feature regularly in academic journals and the press. Misconduct within biomedical research is harmful because it threatens the excellence and progression of biomedical research. It can lead for example to wrong medication and damages trust, both the public’s trust in biomedical research and the mutual trust of biomedical researchers. Biomedical research is increasingly interdisciplinary and international. Therefore a breach in trust has a huge impact.

Throughout this PhD thesis, we focused on three research objectives:  

* What is the situation concerning the research integrity guidance documents of the countries of the European Union (EU) and European Free Trade Association (EFTA)?

* What is the empirical situation concerning research integrity and misconduct within biomedical research in Belgium, both within universities and industry?

* What are the concluding ethical implications concerning the elaboration of aresearch integrity policy?

We opted for an empirical ethics approach. Therefore, the project consists of three phases. In the first phase, a review is made of the official guidance documents on research integrity to map the different policies and strategies towards research integrity guidance within the European economic area. Secondly, both a qualitative and a quantitative study are conducted among biomedical researchers and research managers active within academia and industry. These empirical studies aimed to gauge their perspectives, knowledge and attitudes towards the issues of research integrity and misconduct. Finally, we brought the two previous phases together in a reflection about the concluding ethical implications concerning the elaboration of a research integrity policy.

Our research provided several novel findings. There was heterogeneity between the research integrity guidance documents in Europe concerning various elements, including how research misconduct ought to be defined. Within Europe, various systems were implemented. In northern Europe, it was common to have a national commission to deal with research misconduct allegations. Whereas in southern Europe, no such national commissions existed. In addition, it was often challenging to access the research integrity guidance documents.

Research misconduct occurred to a substantial degree in both universities and industry. Industry and universities upheld different strategies towards research integrity and misconduct. Our analysis revealed several relations with various factors concerning issues of research integrity and misconduct, and the abstract concept of “research integrity” gained a realistic, empirically-based meaning. The ethical evaluation towards research misconduct differed between biomedical research and research managers on the one hand, and research integrity guidance documents in the other hand. The reported frequency of research misconduct related with research integrity training and the ethical evaluation of the listed items of research misconduct.

Based on our research findings, we formulated several recommendations in order to stimulate an agreed upon research integrity policy. We aim to achieve an agreed upon research integrity policy by creating and maintaining a continuous and cyclic interaction between empirical data and research integrity guidance documents. When evaluating a research integrity policy, the perspectives and challenges of biomedical researchers and research managers need to be taken into consideration, within the framework of foundational research integrity principles.