A cross-sectional analysis of ethical approval among studies using the Youth Risk Behavior Surveillance System (YRBSS)

Background: Atrocious violations of human rights have been committed in the name of research, specifically among children, which include the Willowbrook Hepatitis Studies— where children with mental disabilities were purposely infected with hepatitis A and B, and another study in which children were fed radioactive milk or iron supplements. These studies demonstrate the need for Institutional Review Boards (IRBs) and federal regulations to define human subjects research (HSR) and their rights. The Youth Risk Behavior Surveillance System (YRBSS) captures multiple behaviors of youth including physical and sexual violence, bullying, and illicit drug use; yet, data from these surveys is publicly available and is often used in public health research. However, since individually identifiable information is removed from the dataset, a requirement to be considered non-HSR, many universities have listed YRBSS datasets as approved and not requiring IRB submission. As IRBs vary on what is perceived to warrant ethics review, and to our knowledge, no study has investigated the use of YRBSS and IRB submission, our primary aim was to evaluate rates of IRB submission among cross-sectional studies of YRBSS and association among study characteristics.

Study Design: We searched PubMed for cross-sectional studies using YRBSS data published after 2012. Articles were then randomized and two authors screened articles until they independently retained 200 articles. Extracted data included IRB statements, the country of the primary author, and if the study was funded. Descriptive statistics were recorded and chi-square tests were used to measure associations between IBR submission, study characteristics, and publications occuring before and after the 2019 revisions to HHS45-CFR46, although no changes were made to the definition of non-HSR.

Results: Of the 203 studies, 67 (67/203; 33.0%) reported submission to an IRB or ethical review and 46 (46/203; 22.7%) declared the study was not submitted to an IRB or ethical review. Ninety (90/203; 44.3%) did not mention if the study was submitted for IRB or ethical approval. Of the 67 studies that were submitted for IRB approval, 45 (45/67; 67.2%) of the articles were published in journals that required a declaration of ethical determination from a review board. Statistically significant associations were found between IRB statements and studies originating within and outside of the US (X2= 9.3435, P = 0.009), and whether a study received funding (X2=22.8819, P = 0.000), but not among studies published before or after 2019 (X2= 2.39, P = .12).

Conclusions: Two-thirds of the studies in our sample declared that they were submitted to an IRB despite cross-sectional studies of YRBSS data being recognized as non-HSR by many federal institutions, likely to fulfill a journal requirement. Studies with funding and those originating in the US were more frequently submitted for an ethics determination. Standardized guidelines among journals and institutions regarding the secondary analysis of publicly available, federal datasets, would likely ease the burden of IRBs to oversee HSR studies as they were intended.