On April 4, 2014 we announced the start of a Lean process improvement project for Committee on Human Research’s (CHR) office to improve the application and approval process for new studies. Details about the project are available on the project website.

Over the coming months, the CHR office will implement a number of operational and business changes designed to improve the new Full Committee (greater than minimal risk studies) study submission and review process and reduce time to CHR approval. This bulletin includes details about changes being
implemented now:

• Minimum submission standards
• 3-week response deadline for corrections
• “Fast Track” pilot for well-prepared applications

Minimum Submission Standards to Improve Approval Times

We have discovered that poorly-prepared submissions negatively impact the review and approval times of well-prepared submissions by diverting disproportionate time and resources to a small fraction of poorly-prepared submissions. Instituting this new policy will enable CHR staff to focus on well-prepared applications, resulting in faster approvals overall.

Starting May 12, 2014, the CHR will return new study applications that are Incomplete or do not meet the Minimum Submission Standards. Studies that are returned will not be further processed by the CHR staff until the submission is received complete and meets minimum standards. Revised submissions will be processed in order of the date on which they were resubmitted to the CHR.

Instituting this new policy will enable CHR staff to focus on well-prepared applications and reward investigators who put adequate time and effort into ensuring that the applications they submit are ready for review. Full details on the criteria for returning studies unscreened are detailed online.

3-Week Response Deadline for Pre-Review Corrections

As part of a larger campus-wide initiative to speed new clinical trials to enrollment, the CHR has been tasked with reducing the overall time to approval for new full committee studies from 78 days to 42 days. Submission review data have shown that close to 50% of the total time-to-approval (an average of nearly 40 days) is outside of the CHR office’s control (e.g., waiting for the study team to respond to the CHR’s requests for corrections or changes).

New Full Committee Review submissions received on or after May 12, 2014 will be given a 3-week window to respond to pre-review corrections. New study submissions will be withdrawn if a response to request for corrections is not received within 21 days. Post-full Committee review changes will be due
within 45 days.

Receiving responses sooner will lead to faster study approvals.

“Fast Track” to CHR Review for Well-Prepared Applications

The CHR is pilot testing “Fast Tracking” a limited number of applications directly to the CHR committee agenda for review.

To qualify for “Fast Track,” the application must be well-prepared AND the PI must be available for questions by phone during the meeting. Enabling direct communication between the PI and the committee members about study concerns could save time and effort, particularly if issues can be resolved at the meeting in real-time, avoiding protracted back-and-forth electronic communication.

At present, “Fast Track” is a pilot initiative with one of the four committees. The impact on effort and review time will be evaluated at regular interviews to see whether it should be implemented across all the committees.

Future Initiatives

Stayed tuned for future announcements about other CHR efforts to reduce effort and improve efficiency. Some of the other projects include:

• Application Improvements –the CHR is planning to publish a new social and behavioral research specific application and a revised biomedical application later this year
• CHR Review Standards – the CHR is working on common approval standards and reducing variation between the review committees

Please contact the Liz Tioupine CHR at 415-502-3193 or [email protected] with feedback, questions, or concerns.