RESUMEN
THE INSTITUTIONAL REVIEW BOARD-RESEARCHER ASSESSMENT TOOL (IRB-RAT) was designed to assess the relative importance of various factors to the effective functioning of IRBs. We employed the IRB-RAT to gain insight into the ways in which our IRB is perceived to be deficient by those who routinely interact with our Office of Research Integrity and Protections. Respondents ranked qualities thought to be characteristic of an "ideal" IRB and then compared our IRB to that internal standard. We observed that the rate of study participation varied by role. The composite relative ranking of the 45 items that comprise the IRB-RAT differed significantly from the rank order reported by Keith-Spiegel et al. Our data furthermore suggest that role influences scoring of the IRB-RAT (e.g., investigators awarded our IRB significantly higher scores in several areas than did research coordinators). Additional research is warranted to determine if the observed role-dependent differences in the perceived quality of our IRB simply reflect the local research culture or if they are indicative of a more fundamental and generalizable difference in outlook between investigators and research coordinators.
RESUMEN
BACKGROUND: The objective of this study was to measure subject perspective and reaction to participation in the Personalized Medicine Research Project (PMRP) and to identify factors predicting understanding of the study elements. METHOD: Self-administered questionnaires were mailed to 1,593 subjects (10% sample). The questionnaire had three sections: section A consisted of 21 factual questions; section B consisted of 14 questions to assess the level of understanding about the PMRP concepts, and section C asked about the purpose of the PMRP. RESULTS: The mean age of the 924 survey respondents was 52 years (SD = 16.9), with a range of 18-95 years. The majority of participants were female (n = 561, 61%). The percent of total correct responses for section A was significantly higher for females compared with males (males: 58.4% and females: 60.4%, t test = -2.18, p = 0.03) and age was significantly inversely related to percent of correct responses (beta coefficient = -0.122, p < 0.001). More than one third of the participants indicated that the USD 20 greatly influenced their decision to participate in the project. In a multiple logistic regression model, people living outside of Marshfield were significantly more likely to indicate that the USD 20 greatly influenced their decision to participate (odds ratio = 1.40, 95% confidence limit = 1.06, 1.86) and age was inversely related to the monetary influence on decision to participate (odds ratio = 0.98, 95% confidence limit = 0.97, 0.98). CONCLUSION: Future community consultation efforts should highlight areas of lower understanding. In addition, research coordinators may need to take more time informing males and older individuals about project details so that they are making truly informed decisions about study participation.