Academic
Publications
Study Title Is There a Correlation Between Human Subjects Research Training and Satisfaction with the IRB?

Study Title Is There a Correlation Between Human Subjects Research Training and Satisfaction with the IRB?,Ricardo Cruz,Jonathan Woodson

Study Title Is There a Correlation Between Human Subjects Research Training and Satisfaction with the IRB?  
BibTex | RIS | RefWorks Download
Methods: We conducted an anonymous online survey of BUMC researchers. We asked about researchers' roles/experience, treatment by the IRB, views on ethics training, and satisfaction with the IRB and its education. Sample size was determined based on feasibility and to allow as many researchers as possible to respond. Descriptive statistics were used to characterize the study population; differences were assessed using chi-square test or Fisher's exact test. Bivariate analyses of variance were used to evaluate differences in researcher views of IRB training and satisfaction. Two multivariate models were then developed to identify predictors of IRB satisfaction and education. This study was reviewed and approved by the BUMC IRB. Results: 357 individuals completed the survey (response rate: 10.8%). 43% were principal investigators (PIs); 20% co-investigators (CIs); 25% project managers (PMs); and 12% research assistants (RAs). Results showed greater dissatisfaction with the IRB among PIs/CIs compared to PMs/RAs (p=0.01). The most important predictors of IRB satisfaction at BUMC on multivariate analysis were: 1) IRB effectiveness in enforcing ethics/Federal regulations (p<0.0001); 2) Not perceiving the IRB as a hurdle (p<0.0001); 3) Considering investigator input on protocols (p<0.0001); and 4) Availability of the IRB staff (p<0.0001), Director and Chairs (p=0.001). Conclusions: While the IRB's role in ethical research was viewed favorably, PIs/CIs still perceive the IRB negatively. PIs/CIs may not fully understand the IRB's role in protecting human subjects. Limitations: These findings may be unique to BUMC and non-generalizable to other institutions and IRBs. In addition, while there may be reduced external validity due to self-selection of respondents we believe that there is little threat to internal validity due to selection bias. Next Steps: While useful to PMs and RAs, BUMC's current educational approaches may need revision to better meet the needs of PIs/CIs. This survey was also important in communicating with the research community and identifying areas for improvement . Abstract #
Cumulative Annual
View Publication
The following links allow you to view full publications. These links are maintained by other sources not affiliated with Microsoft Academic Search.