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.

Public Health Relevance

The purpose of this proposed investigation is to explore the phenomena of academic-industry relationships (AIRs) among members of academic IRBs. Also, this study is intended to document how AIRs among IRB members and chairs have changed in recent years. The results of this research will inform IRB, institutional and governmental policies regarding the AIRs among IRB members and IRB chairs.

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Research Project (R01)
Project #
5R01GM100026-03
Application #
8664895
Study Section
Special Emphasis Panel (ZRG1-SEIR-B (01))
Program Officer
Krasnewich, Donna M
Project Start
2012-09-01
Project End
2015-05-31
Budget Start
2014-06-01
Budget End
2015-05-31
Support Year
3
Fiscal Year
2014
Total Cost
$212,666
Indirect Cost
$90,444
Name
Massachusetts General Hospital
Department
Type
DUNS #
073130411
City
Boston
State
MA
Country
United States
Zip Code
02199