Abstract
BackgroundPrevious studies have indicated that failure to report ethical approval is common in health science articles. In social sciences, the occurrence is unknown. The Swedish Ethics Review Act requests that sensitive personal data, in accordance with the EU General Data Protection Regulation (GDPR), should undergo independent ethical review, irrespective of academic discipline. We have explored the adherence to this regulation.MethodsUsing the Web of Science databases, we reviewed 600 consecutive articles from three domains (health sciences with and without somatic focus and social sciences) based on identifiable personal data published in 2020.ResultsInformation on ethical review was lacking in 12 of 200 health science articles with 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 ethical 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 ethical approval.ConclusionsWe conclude that reporting of research ethics approval is reasonably good, but not strict, in health science articles. Failure to report ethical approval is about three times more frequent in social sciences compared to health sciences. Improved adherence seems needed particularly in observational studies, in articles with few authors and in social science research.
Highlights
Previous studies have indicated that failure to report ethical approval is common in health science articles
Articles were included if they fulfilled the following criteria: (a) health or social sciences, (b) study with original data, (c) containing personal data according to General Data Protection Regulation (GDPR) [7]: racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health or data on sex life or sexual orientation, (d) personal data on crimes, convictions and certain other legal decisions as specified in the Ethical Review Act, and (e) personal data collected in Sweden; this latter criterion was used because, in multinational collaborations, information was usually not provided about in which country the analyses had been performed
In health science articles with somatic focus, the proportion lacking information on ethical approval was low in all subcategories: surgical focus (3 of 39; 8%), non-surgical focus (9 of 138; 7%), and laboratory focus (0 of 13)
Summary
Previous studies have indicated that failure to report ethical approval is common in health science articles. The Swedish Ethics Review Act requests that sensitive personal data, in accordance with the EU General Data Protection Regulation (GDPR), should undergo independent ethical review, irrespective of academic discipline. GDPR is implemented in the Swedish Ethical Review Act [8]. According to the Act, ethical review is mandatory for (a) research that involves personal data that in the Swedish Act are termed “sensitive”, identical to data defined in GDPR, article 9.1, as “special categories of personal data” [10, 11], (b) research that involves physical encroachment on an individual or uses a method that aims to affect the subject physically or psychologically, and (c) studies on biological material traceable to specific individuals. There may be pros and cons of strict regulation of research ethics reviews, including law-making, and the Act and its limitations has been debated in the law literature (e.g. [12, 13])
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