Changes in the institutional review board submission process for multicenter research over 6 years

Abstract

While collaborative research across sites is essential to increase the statistical power and generalizability of research findings, the need to undergo multiple IRB reviews is a challenge. The purposes of this paper are to describe changes in the IRB submission process in two 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. Keywords human subjects; Institutional review boards; research ethics; clinical researchOversight of human subjects research is an ethical as well as a legal imperative. Such oversight is generally delegated to local institutional review boards (IRBs), whose mandate is to assure that regulatory and ethical standards are upheld in research protocols.1 , 2 Although federal regulations regarding research are mandated only for protocols receiving federal funding, these same standards are generally applied to all research, regardless of whether a project receives external funding or is unfunded. Several recent reviews have reported wide variation and substantial challenges in how IRBs handle multisite studies.3 -5 To encourage standardization of human subject protections in research, IRBs or independent ethics committees must be registered through the Office of Human Research Protections (OHRP). There are currently thousands of such registered boards. In California alone, for example, there are >2,000 registered IRBs and in New York there are >1, 400. 6 In addition to OHRP oversight, the Health Information Portability and Accountability Act (HIPAA) Privacy Rule 7 enacted in 2003, has resulted in major changes in how personal health information is handled. The IRB is charged with the responsibility of monitoring © 2010 Mosby, Inc. All rights reserved. mp2422@columbia.edu . Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. adherence to HIPAA regulations as part of the approval process for research protocols. In order to better understand the current status of the review of human subjects research and the impact of HIPAA on the IRB process, we examined our experiences in two na...

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