Spotlight on an abstract from the 2009 Advancing Ethical Research Conference.
Title: Investigator Dissatisfaction with the IRB Approval Process
Authors: Steven Pennell, MBA, MA; Ronald Maio, DO, MS; James Lepkowski, PhD
Affiliation: University of Michigan
Abstract summary: Little empirical data, but much anecdotal information, characterizes researcher experience with the human subjects regulatory system. This research contributes to advancing knowledge about how researchers experience the human subjects regulatory system by asking:
- What is the relationship between time to approve an application and researcher dissatisfaction with the IRB’s core service;
- What factors are associated with dissatisfaction with the IRB approval process;
- Are these correlations system-related, characteristics of researchers, or both; and
- What is the strength of the relationship among these correlations and investigator dissatisfaction?
To answer these questions, the University of Michigan’s Institute for Social Research conducted an IRB approved scientific survey among 1,800 investigators. Results indicate several statistically significant outcomes:
- Investigators support the concept of ethical/regulatory review of research, but take exception with how IRBs “operationalize” it;
- Dissatisfaction with the IRB approval process is significantly associated with system-related outcomes and attitudes shaped by those outcomes. The time to approve applications is a key determinant of dissatisfaction: The odds ratio of dissatisfaction increases dramatically when approval times exceed four weeks when controlling for other covariates in the model. Other significant system-related correlates are unanswered investigator inquiries to the IRB, IRB-required application changes, and difficulty using the application system.
SP and RM: There is a dearth of empirical evidence to show whether IRBs, in general, monitor investigator experiences with the local regulatory environment and what actions, if any, are taken. The research conducted at the University of Michigan demonstrates that empirical evidence can lead to positive changes. Nevertheless, some changes require paradigm shifts that can be challenging for institutions to navigate: for example, cultivating customer-centric relationships and systems. A copy of the University of Michigan report is available here.