Inconsistent ethics reporting in individual participant data meta-analyses: a call for updating PRISMA and PRISMA-IPD.

Abstract

Background: Interest in performing individual participant (or patient) data meta-analysis (IPD-MA) from randomized controlled trials (RCTs) has increased in recent years. With our PubMed search approach which considered only the titles of the articles and was conducted in October 2025, the first IPD-MA was published in 1998, whereas 198 were published in the first 9 months of 2025. Researchers use PRISMA 2020 and, above all, PRISMA-IPD to report the results of these studies.

Main text: There are five ethics items─which are not included in either PRISMA 2020 or PRISMA-IPD─that are inconsistently included in the IPD-MA published in prominent medical journals, as shown in a sample of 19 IPD-MAs published in top general/internal medicine journals between January and September 2025. Two items refer to the RCTs included in the meta-analysis, i.e., whether approval from a research ethics committee (REC) was obtained, and whether participants of those trials provided informed consent. The other three items refer to the IPD-MA itself, i.e., whether it was approved by an REC, what the de-identification status was for the data (i.e. pseudonymized vs. anonymized), and whether the participants in all the trials included in the meta-analysis had given their consent or had not objected to the secondary use and sharing of their data with third parties.

Conclusions: Due to their relevance, readers should be informed about these five items in the text of the IPD-MA or, as an alternative in certain cases, in the disclosure section of the IPD-MA published report. Specifically, the two items of information concerning the trials included in the IPD-MA should be included in an updated PRISMA 2020. All five items should be included in the next update of the PRISMA-IPD.