Background. Previous studies have indicated that the failure to report ethics approval is common in health science articles. In social sciences, the occurrence is unknown. The Swedish Ethics Review Act applies to all human research and requests that personal data, as defined by the EU General Data Protection Regulation (GDPR), should undergo independent ethical review. We have explored the adherence to this regulation.
Methods. Using the Web of Science databases, we reviewed 600 consecutive articles from three domains (health sciences with and without somatic focus and the social sciences) based on identifiable personal data published in 2020.
Results. Information on ethical review was lacking in 12 of 200 health science articles with a somatic focus (6%), 21 of 200 health science articles with non-somatic focus (11%), and in 54 of 200 social science articles (27%; p<0.001 vs. both groups of health science articles). Failure to report on ethics approval was more common in (a) observational than in interventional studies (p<0.01), (b) articles with only 1-2 authors (p<0.001) and (c) health science articles from universities without a medical school (p<0.001). There was no significant association between journal impact factor and failure to report ethics approval.
Conclusions. We conclude that reporting of research ethics approval is reasonably good, but not strictly adhered to, in health science articles. Failure to report ethics approval is approximately three times more common in the social sciences. Adherence needs to be improved, particularly in observational studies, articles with few authors and social science research.