Challenges faced by IRB Approved Studies due to Sample Size Shortfalls and Low Patient Accrual
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Abstract
Institutional Review Boards (IRBs) play a critical role in upholding ethical standards and safeguarding the welfare of research participants. However, continued issues with sample size short falls and low patient accruals remain some of the greatest challenges IRB-approved studies face. This thesis undertakes comprehensive evaluation of these challenges, examine their complexities and ethical implications. Drawing on a literature review, two pilot studies, and a detailed methodology, the research investigates the prevalence and impact of sample size discrepancies, explores factors influencing patient accrual rates, and evaluates the role of funding mechanisms and study sites. Findings reveal discrepancies between proposed and actual sample sizes and durations, shedding light on the complexities of study execution. Moreover, the study uncovers no significant differences in patient accrual rates based on funding sources or study sites. Through rigorous analysis, this thesis provides valuable insights into the ethical considerations and practical challenges faced by IRBs, offering recommendations to enhance research integrity and participant welfare.
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Introduction -- Review of literature -- Methodology -- Results -- Discussion
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M.S. (Master of Science)