Challenges faced by IRB Approved Studies due to Sample Size Shortfalls and Low Patient Accrual

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.

Name thesis:degree_name

M.S. (Master of Science)

Level thesis:degree_level

Masters

Discipline thesis:degree_discipline

Bioinformatics (UMKC)

Grantor

University of Missouri--Kansas City

Year dc:date.issued

2024

Author dc:creator

• Mahankali, Madhumitha

Advisor dc:contributor.advisor

• Simon, Steve (Professor of biomedical and health informatics)

Handle dc:identifier.uri

https://hdl.handle.net/10355/101821

OAI identifier oai:identifier

oai:mospace.umsystem.edu:10355/101821