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Length of time needed for institutional review board approval or exemption of quality improvement projects among subset of U.S. training programs.


Conforti LN, Ross K, Hess BJ, Lynn LA, Holmboe ES. — American Board of Internal Medicine

Presented: Academy for Healthcare Improvement, IHI National Meeting, December 2008

Background: Graduate medical education trainees must demonstrate competency in practice-based learning and improvement and systems-based practice. The American Board of Internal Medicine developed Practice Improvement Modules, Web-based tools, to address these competencies. PIMs use chart abstraction, patient surveys, and a practice-system survey to assist data collection and quality improvement (QI) planning. A feasibility study in the training setting found the PIM was valuable and resulted in self-reported changes in clinical practice and increased confidence levels regarding resident QI skills. However, training programs face barriers with local Institutional Review Boards (IRBs), experiencing confusion with forms and processes that do not seem to fit goals of QI projects/studies.

Purpose of the Study: The purpose of this study was to calculate the length of time that elapsed from initiation of the IRB process to IRB approval or exemption among 46 residency training programs involved in a nationwide comparative trial.

Methods: Forty-six internal medicine and family medicine residency programs participated in the Improving Quality of Care for Elderly Patients in the Educational Setting Study investigating the effectiveness of ABIM’s Care of the Vulnerable Elderly (CoVE) PIM to improve teaching and quality of care for elderly patients. All programs received a completed IRB template and a draft consent form. On June 15, 2006, the study coordinator instructed participants to contact their local IRB to learn about requirements and inquire about exemption eligibility (no identified data would be leaving the practice site).

This study reports the mean, median and range length of time programs experienced from initiation to receipt of IRB approval/exemption.

Results: Of the 46 programs, four withdrew from the study (IRB approval pursuit unknown). Eight programs received expedited approval. Four IRBs found the study to be exempt. The remaining 30 programs required a full approval process. The time period to approval/exemption ranged from less than one week to 56.5 weeks (see chart); mean and median time was about 18 weeks, resulting in a number of programs unable to begin the study within the pre-specified time zero period. The study allotted four months for IRB approval; 22 programs (48%) did not start until after that time.

Conclusions and Implications: Length of time from initiation to approval/exemption and nature of the approval process was highly variable across institutions, impacting the overall national study, as opportunities to implement quality improvement initiatives were time-sensitive. Many participants believed IRB requirements were inappropriate for quality improvement and more fitting for biomedical research.

IRB barriers markedly changed the time zero for study implementation across the programs, making meaningful comparisons more difficult in a study that was funded over a fixed time interval. Large amounts of effort spent on difficult IRB processes can lead to reduced motivation and buy-in for the study interventions. Publishing results on QI initiatives and research is crucial to building a stronger body of knowledge about and dissemination of effective (and ineffective) interventions across residency programs. A standardized approach for IRB review of QI projects/studies could help inexperienced clinician-educators implement QI research projects.

See presentation (pdf)

For more information about this presentation, please contact Research@abim.org.