Should informed consent and information related to patient recruitment in clinical trials be available to the reader of scientific articles? A case study in dentistry

Ethical aspects in research should be transparently reported. This study aimed to investigate whether informed consent and information related to patient recruitment in clinical studies are well reported in the scientific literature. Randomized clinical trials (RCTs) on root coverage procedures published between November 2016 and November 2021 were selected from the PubMed database. Items/questions were used to guide the extraction of data related to patient recruitment, with a focus on the detailed report of informed consent used to clarify the research to the patient. Data were extracted from the published article and the respective research protocol published in a public registry. Information related to potential selective outcome reporting (SOR) was also extracted. In total, 187 documents were initially screened and 74 reports of RCTs were included. No informed consent was published in the article. Only one research protocol provided a link to the informed consent. Deviations from reporting in the research protocol and published article were found, suggesting SOR. Informed consent and information related to patient recruitment in RCTs on root covering procedures are severely underreported. The present findings may stimulate further discussion and debate on the need for making this information publicly available.

Automated summary

This study investigated the reporting of informed consent and patient recruitment information in clinical studies, particularly focusing on randomized clinical trials (RCTs) on root coverage procedures. The findings revealed a severe underreporting of informed consent and patient recruitment information in the published articles, suggesting a potential issue of selective outcome reporting.