The purpose of the proposed research is to understand the nature, extent, consequences and changes in AIRs among IRB members and chairs. The specific aims of this study are: 1. To explore the frequency and predictors of AIRs among IRB members and IRB chairs and to compare these findings with the results from 2005 . 2. To explore the disclosure and management practices of AIRs among IRB members and IRB chairs and to compare these findings with the results from 2005. 3. To explore the interface between the IRB and the Institution with regards to the AIRs of clinical researchers. The proposed study will rely on qualitative and quantitative data. Qualitative data collection will consist of focus groups and personal interviews IRB members and chairs in research intensive medical schools and teaching hospitals. The quantitative data will involve a mailed survey of a random sample of 893 members and 316 chairs at 100 most medical schools nationally and 15 most research intensive hospitals. The sample for the survey will be constructed using publicly available data from the Office of Human Research Protections at the Department of Health and Human Services. The survey will be constructed using questions adapted from previous surveys as well as new items. The instrument will be pre-tested using cognitive interviews and a formal mailed pretest. The survey itself will collect information regarding the prevalence, nature, and extent of AIRs and IRB policies and practices in regard to AIRs from IRB members and chairs. Results will be disseminated through publications in peer-reviewed journals and presentations at scientific meetings.

R01GM100026

2012-09-01

2016-11-30