Changes in the institutional review board submission process for multicenter research over 6 years.
Although collaborative research across sites is essential to increase the statistical power and generalizability of research findings, the need to undergo multiple institutional review board (IRB) reviews is a challenge. The purposes of this paper are to describe changes in the IRB submission process in 2 national multisite studies before and after the implementation of the Health Information Portability and Accountability Act (HIPAA) Privacy rule (2002 and 2008) and to discuss implications for policy and practice related to human subjects research. In the second study, there was a shorter mean approval time and reduced variability in the decision about the level of review, the mean number of pages per application doubled, and an increased proportion of IRBs required conflict of interest and data use agreements. Possible approaches to further enhance the efficiency and streamlining of the research review process are suggested.
Pogorzelska
Monika
M
Columbia University School of Nursing, Columbia University, New York, NY 10032, USA. mp2422@columbia.edu
Stone
Patricia W
PW
Cohn
Elizabeth Gross
EG
Larson
Elaine
E
D000704:Analysis of Variance; D016009:Chi-Square Distribution; D016265:Conflict of Interest / Q000331:legislation & jurisprudence; D003625:Data Collection / Q000941:ethics / Q000331:legislation & jurisprudence; D003627:Data Interpretation, Statistical; D017598:Efficiency, Organizational; D028744:Ethics Committees, Research / Q000458:organization & administration*; D033161:Government Regulation; D020408:Health Insurance Portability and Accountability Act / Q000458:organization & administration*; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D015337:Multicenter Studies as Topic / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards; D015399:Nursing Research / Q000941:ethics / Q000458:organization & administration*; D009936:Organizational Innovation; D009937:Organizational Objectives; D012107:Research Design / Q000331:legislation & jurisprudence; D013997:Time Factors; D014481:United States; D018172:United States Office of Research Integrity / Q000458:organization & administration