Compliance with research participant protection guidelines by Nigerian medical journals.

Abstract

Background: Stakeholders in medical research have roles in ensuring that research participants are protected. Medical journals play gatekeeping roles in the responsible conduct of research. They help guard against the publication of findings of unethical research, such as those with compromised participant welfare. Nigerian medical journals are being created to support the growing number of research enterprises. In this study, we aimed to determine the compliance of Nigerian medical journals with guidelines on research participant protection.

Methods: This was a descriptive cross-sectional study of Nigerian medical journals and articles. We used a checklist to obtain information on journal characteristics and the presence of recommendations from the International Committee of Medical Journal Editors (ICMJE) on the protection of research participants in the journal instructions to authors and articles. The data were analysed via IBM SPSS version 23.

Results: We studied 40 journals and 350 journal articles. Thirty-one (77.5%) journals required ethical approval and the Declaration of Helsinki statement in their instructions to the authors, while informed consent was present in 26 (65.0%) journals; 6 (15.0%) journals had no participant protection guidelines. Forty-one (11.7%) articles complied with all three recommendations on research participant protection, whereas 60 (17.1%) articles did not. Ethical approval was most common in 268 (76.6%) articles, whereas it was least common in statements on the Declaration of Helsinki in 50 (14.3%) articles. The presence of participant protection recommendations in instructions to authors was not associated with compliance with these recommendations in published articles (p > 0.05).

Conclusion: Although there is fairly good compliance of Nigerian medical journals with research participant protection recommendations, there are still gaps, which highlight the need for remedial measures.