Abstract
BackgroundTo investigate the factors related to approval after review by an Institutional Review Board (IRB), the structure equation model was used to analyze the latent variables ‘investigators’, ‘vulnerability’ and ‘review process’ for 221 proposals submitted to our IRB.MethodsThe vulnerability factor included vulnerable cases, and studies that involved drug tests and genetic analyses. The principal investigator (PI) factor included the license level of the PI and whether they belonged to our institution. The review factor included administration time, total review time, and revision frequency. The revision frequency and total review time influenced the efficiency of review.ResultsThe latent variable of reviewing was the most important factor mediating the PIs and vulnerability to IRB review approval. The local PIs moderated with genetic study and revision frequency had an impact on the review process and mediated non-approval.ConclusionsBetter guidance of the investigators and reviewers might improve the efficiency with which IRBs function.
Highlights
To investigate the factors related to approval after review by an Institutional Review Board (IRB), the structure equation model was used to analyze the latent variables ‘investigators’, ‘vulnerability’ and ‘review process’ for 221 proposals submitted to our Institutional Review Boards (IRBs)
Proposals to improve the performance of IRBs include increasing the efficiency of the review process and reducing the amount of time devoted to administrative tasks prior to board review [1]
The study design met the requirements of the Helsinki Declaration and the design was approved by the IRB of the Armed Forces Kaohsiung General Hospital
Summary
To investigate the factors related to approval after review by an Institutional Review Board (IRB), the structure equation model was used to analyze the latent variables ‘investigators’, ‘vulnerability’ and ‘review process’ for 221 proposals submitted to our IRB. Institutional Review Boards (IRBs) assess research proposals to ensure that they adhere to research regulations, adequately protect the rights and welfare of study participants, and are ethically sound. Accreditation of an IRB by the National Health Institute ensures that human safety is not compromised during the conduct of approved medical research. An IRB should assess the adequacy of structural, procedural, and performance-related aspects of all studies brought before it. Principal investigators (PIs) complain that the problems of the review process conducted by IRBs include the inefficiency with which it identifies irrational decisions [6] and its inconsistency [7]. Proposals to improve the performance of IRBs include increasing the efficiency of the review process and reducing the amount of time devoted to administrative tasks prior to board review [1]
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