PRIM&R’s Abstract Spotlight

In this series of Ampersand posts, PRIM&R touches base with those who presented programmatic and research-based findings at past PRIM&R conferences.

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:

  1. What is the relationship between time to approve an application and researcher dissatisfaction with the IRB’s core service;
  2. What factors are associated with dissatisfaction with the IRB approval process;
  3. Are these correlations system-related, characteristics of researchers, or both; and
  4. 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:

  1. Investigators support the concept of ethical/regulatory review of research, but take exception with how IRBs “operationalize” it;
  2. 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.
The results suggest that reducing dissatisfaction with the IRB approval process will require recalibration of system-related features of HRPPs, above all reducing the time to approve applications. Repeated surveys will monitor system changes and their effect on key outcomes, including dissatisfaction with the IRB approval process. A national survey is planned.

PRIM&R Staff (PS): In the months since you presented this abstract at PRIM&R’s 2009 AER Conference, how has your research changed or evolved?
Steven Pennell, MBA, MA and Ronald Maio, DO, MS (SP and RM): IRBs rarely have direct relationships with human subjects participating in research and must rely on investigators and members of their research teams to implement safeguards to protect them from harm. The IRB-investigator fiduciary relationship can be facilitated by monitoring investigator experiences with the local regulatory environment.
Our initial survey identified time to approve research as a key correlate of investigator satisfaction with IRB services. While this relationship is intuitive, institutions can be more deliberate in their actions when they understand the tipping point between satisfaction and time to approve research. Since the initial University of Michigan survey, institutional efforts have been undertaken to streamline the approval process.
Subsequently, in late fall 2009 and early winter 2010, we conducted a follow-up survey to measure investigator satisfaction with IRB services. Those survey results will be available soon. Initial findings indicate that overall satisfaction with the IRB review and approval process has improved.

PS: What challenges have you faced in advancing your research?

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.

For questions or comments about this program, please contact Steven Pennell or Ronald Maio.
Interested in submitting an abstract to present at PRIM&R’s next animal or human research ethics conference? Please e-mail us for more information.