Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Clinical Trial

Abstract

Abstract.Multicenter clinical trials require approval by multiple local institutional review boards (IRBs). The Multicenter Airway Research Collaboration mailed a clinical trial protocol to its U.S. investigators and 44 IRBs ultimately reviewed it. Objective: To describe IRB responses to one standard protocol and thereby gain insight into the advantages and disadvantages of local IRB review. Methods: Two surveys were mailed to participants, with telephone follow-up of nonrespondents. Survey 1 was mailed to 82 investigators across North America. Survey 2 was mailed to investigators from 44 medical centers in 17 U.S. states. Survey 1 asked about each investigator's local IRB (e.g., frequency of meetings, membership), whereas survey 2 asked about IRB queries and concerns related to the submitted clinical trial. Results: Both surveys had 100% response rate. Investigators submitted applications a median of 58 days (interquartile range [IQR], 40-83) after receipt of the pro-

Institutional Variability in a Minimal Risk, Population‐Based Study: Recognizing Policy Barriers to Health Services Research

“…The potential for selection bias in minimal risk, observational research requiring informed consent (Tu et al 2004) and variability in IRB review (Bennett et al 2001;Silverman, Hull, and Sugarman 2001;Stair et al 2001;Hirshon et al 2002) have been previously described. However, there has not been previous research assessing the potential impact of federal research policy (i.e., the Privacy Rule and need for federalwide assurances) on health services research.…”

Ethics application protocols for multicentre clinical studies in Canada: A paediatric rheumatology experience

“…Ultimately, all sites gave approval but not without considerable time and effort by both investigators and institutional review board members. Eight studies reported differences in the approach to consent, similar to our experience with the BBOP study (7). In particular, with juvenile subjects, research ethics committees focused on the children's status as vulnerable and expressed concerns about consenting procedures as well as emphasizing the need for children to be protected in research (8).…”

Protocol-writing support conferences for investigator-initiated clinical trials

“…In addition, a single site might bias the results because IRBs show extreme variability in their initial responses to standard protocols. 26 We need more trials that cover all types of trials planned regardless of time (eg, all early protocols) and locations (eg, university, general hospital, research institute). Second, participants were not randomized; hence, we could not simply compare early and rejected protocols.…”