Ethical approval and informed consent in mental health research: a scoping review

Ethical approval and informed consent in mental health research: a scoping review

Leona Cilar Budler, Gregor Stiglic

AI and Society, 1 May 2025

Abstract

Although there is a wide range of scientific papers introducing artificial intelligence techniques in the mental health field, there is a lack of literature assessing the reporting of ethical concerns in such studies. In addition, it is not yet known whether the authors seek ethical approval or informed consent while performing such research. This study aimed to investigate the extent to which studies in the mental health domain that utilize chatbots either ignore or incompletely disclose patient consent and ethical approval from the responsible review boards. A scoping literature search was performed in PsychARTICLES, PubMed, and Web of Science using both MeSH terms and free-text keywords. Following PRISMA-ScR guidelines, we also contacted study authors to verify missing information about ethical approval or informed consent, enhancing the transparency and rigor of our analysis. Among the 27 studies reviewed, 13 reported obtaining ethical approval, and 16 reported collecting informed consent. The remaining studies did not provide such information. These findings underscore the ethical complexities surrounding AI in mental health, especially regarding the collection, storage, and use of sensitive patient data. There is a correlation between sample size and the acquisition of ethical approval, particularly in studies published in journals with low-impact factors. Future research should investigate the role of journal policies in influencing ethical practices. In addition, training programs could be developed to educate researchers on the importance of ethics, particularly in studies with smaller sample sizes.