Cross-sectional Analysis of IRB Submission Prevalence Among Studies Using

Research output: Contribution to conferencePosterpeer-review


Background: In 1974, the National Research Act established institutional review boards (IRBs) to cease and prevent the unethical treatment of humans within medical research. It is the duty of researchers and IRBs to determine what research should be reviewed for ethical violations. For example, research not involving human subjects does not often require IRB review. With fewer constraints, non-human subjects research — such as cross-sectional analyses of ( — can be conducted with fewer resources and provide insight into trial outcomes, outcome reporting, and resource allocation. Owing to the proximity of these analyses with human subject data we sought to determine: (1) the rates of IRB submission; (2) associations of IRB approval and additional data inquiries with trial investigators; and (3) associations between IRB submission and extracted study characteristics.

Study Design: PubMed was queried for publications that included “” in the title or abstract published after 2011. We randomized then screened the first 700 articles. In a masked, duplicate fashion, we extracted the article’s title, whether it made correspondence for additional data, country of the primary author, IRB statement, and if the study was funded. Frequencies were calculated for all extracted characteristics and chi-square tests were conducted to measure associations between IRB submission and extracted study characteristics.

Results: Of 57 articles included, zero declared that they were submitted to an IRB or ethics review panel. Forty-two studies (of 57, 73.7%) did not include an IRB or ethical review statement while 16 (of 57, 28.1%) studies did include a statement of IRB exemption. Four (of 57, 7.0%) studies reported contacting the principal investigator to collect additional data. Two of these four studies included IRB statements. No significant associations were found between studies with IRB declarations and those with no mention of ethical approval among any study characteristics.

Conclusions: Nearly three-quarters of meta-research examining data from did not include a statement regarding IRB or ethical approval. These studies were likely determined exempt by the authors or the institutional IRBs under the Code of Federal Regulations — 45 CFR 46.101. The remaining quarter of studies in our sample explicitly declared exemption from the IRB. Four of the studies contacted trial investigators and under strict interpretation of regulation, these methods may constitute “interview” procedures involving human subjects research; however, current policy — 45 CFR 46.104(d)(2)(i) — states these studies are exempt if data do not include information that may identify subjects, and in these cases, are not the unit of analysis. Taken together, these findings suggest that ethical approval for meta-research of data regularly meet federal exemption criteria.

Original languageAmerican English
StatePublished - 22 Feb 2021
EventOklahoma State University Center for Health Sciences Research Days 2021: Poster presentation - Oklahoma State University Center for Health Sciences Campus, Tulsa, United States
Duration: 22 Feb 202126 Feb 2021


ConferenceOklahoma State University Center for Health Sciences Research Days 2021
Country/TerritoryUnited States


  • Cross-sectional Analysis
  • Human Ethics
  • IRB Submission


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