IRB Expedited & Exempt Review Metrics and Submission Tips
The Association for the Accreditation of Human Research Protection Programs (AAHRPP) released data collected from its group of 196 accredited organizations in June 2010. The metrics were released to help research organizations and researchers identify and support high-performing practices for human research protection programs (HRPP). The data ranges from types of research and conformance with regulations and guidance to financial and personnel resources and IRB review times. The University of Minnesota’s HRPP took these metrics, compared them to their own, and has since implemented some initiatives to improve its service.
The University placed in the top tier of research institutions in protocols overseen, as 2,053 protocols were approved by its IRB office in 2009 and the office maintains 5,076 active protocols. This volume placed the University above the mean number of protocols overseen (851), and well above the median number (306).
The data from the survey showed that the University has less staff with 20 full-time employees (FTE) than comparable accredited organizations, which average 30 FTE. This correlates to 70 more protocols processed per FTE at the University.
One of the highlights of the survey was data on review time for accredited organizations. The institution has always strived to turn around submissions as efficiently as possible, but determining what is a reasonable amount of time has not previously been defined.
Further Comparative Analysis
Regarding exempt reviews, the University was on par with accredited organization averages in 2009, and has made progress reducing the number of days required for review through the first quarter of 2010.
The department has applied some of the lessons used in reducing review time in exempts towards expedited review, and has reduced the review time nearly in line with averages for accredited organizations. To exceed those averages staff have identified common issues that are simple to fix, yet may cause delays in processing research submissions unless they are addressed.
IRB Submission Tips
For Medical Record Chart Review:
- When a link to protected health information (e.g., the patient names or medical record numbers) is maintained separately from the data, it should be noted that the IRB still considers a link to exist
- The Medical Record Chart Review application allows the researchers to select the level of review appropriate for the research. If the Principal Investigator thinks their research will qualify for expedited review, initially selecting the most accurate category of review will assist in a more expedient approval (e.g., “Research including a retrospective and prospective chart review” is considered expedited).
For All Projects:
- Electronic applications need to be sent to email@example.com using an official University of Minnesota email account; email providers such as Gmail, Hotmail, or Yahoo! cannot be accepted
- Remember to cc your advisor and any co-Investigators associated with the research application using their official University of Minnesota email account
- Submit any surveys, questionnaires, recruitment materials, supporting documents, and consent forms with the application
- Indicate completion of Human Research Subjects’ Protection training in the appropriate portion of the application.