Investigating Perceived Institutional Review Board Quality and Function Using the IRB Researcher Assessment Tool.

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.

Informed consent and subject motivation to participate in a large, population-based genomics study: the Marshfield Clinic Personalized Medicine Research Project.

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.