Browsing Indiana State University Electronic Theses and Dissertations by Subject "Adverse event."
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Reporting Problems in Human Subjects Research: a Comparative StudyThe purpose of this study was to discover whether differences exist among institutional review boards (IRBs) in categorizing and reporting problems in social science research to the Office for Human Research Protections (OHRP). IRBs were grouped by institutional size and type. The study also employed an experimental design to look for differences among those who reviewed a decision chart from OHRP (experimental group) and those who did not review the decision chart (control group). From a population of 474 IRB contacts at public, four-year institutions of higher education, 187 survey responses were received. Factorial ANOVA and independent measures t-tests were conducted to look for differences in responses among groups of IRBs. Statistically significant differences were found in how IRBs of different types categorized the incident presented in the survey. IRBs that review more biomedical protocols were less likely than social/behavioral IRBs to categorize an incident as an adverse event but more likely to categorize the incident as an unanticipated problem. Analysis revealed no significant differences among groups in the decision to report the incident to OHRP. The differences between IRB types suggest that IRB experience and institutional context affect IRB decisions. Recommendations are made for revising OHRP reporting guidance, IRB training, and board management.