Improving the Efficiency of Protocol Reviews and Approvals

1. Improving the Efficiency of Protocol Reviews and Approvals Alison D. Pohl, MS, rLATg, CPIA Research Compliance Monitor / IACUC Administrator University of Connecticut Health Center Farmington, CT

2. What is “improving” protocol review? • From the PI’s perspective: • Only one review (e.g., no “back and forth” revisions) • Focus on the “important stuff”, not the small details • Make it as easy on me as possible • From the IACUC’s perspective: • Catch everything that is important (one review may not be enough) • Make it as easy as possible for the IACUC • Try to make it as easy as possible for the PI

3. What is “improving” approval efficiency? • From the PI’s perspective: • Get my approval as fast as possible (preferably yesterday) • From the IACUC’s perspective: • Get the approval done as fast as possible (though yesterday is probably not possible) Seems like there is a shared goal here??

4. What can the PI do to improve the efficiency of a review? • Submit a thoughtful and complete protocol that tells the whole story • Make sure all questions are answered • Make sure the answers to the questions are actually answers to the questions; in other words, don’t answer the question with incomplete or incorrect information • Submit protocols by established deadlines • Submit protocols for a pre-review if that activity is performed by an institution • When submitting revisions after IACUC review • Make sure all comments are addressed

5. What can the IACUC do to improve the efficiency of a review? • Perform pre-reviews • Can be done by the IACUC administrator to a great degree • Veterinary pre-review can be very important • Ensure IACUC members know what constitutes an appropriate review • Reviews should be consistent between protocols and IACUC members • Training, training, training! • Have the IACUC invested in the research of the institution • Complete reviews by an assigned deadline • Do your review as if you were the PI (be kind) • Utilize DMR when you can • One way to improve efficiency is….

6. Go Electronic • Can help you make the whole protocol review and approval process faster, more thorough, and more consistent • Does not mean just using an electronic protocol development and review system (either commercial or home-grown) • Electronic methodologies can mean more version control, less chance of losing vital information, and increased access to information for both the PI and the IACUC • And you have the added benefit of “being green”

7. Non-system electronic methods • Shared electronic drives (through your IT department) • All IACUC members can access all information • Information access is restricted to those members who have been “allowed” access • Typically backed up by the Institution so that data loss is unlikely • Electronic signatures (e.g., use of Adobe Acrobat) • Takes less time because you do not have to physically go to someone’s office for a signature • Accepted by most agencies (OLAW, USDA, NIH, etc.) • Web-based sign up services (e.g., Signupgenius.com) • Can be used for facility inspections and meetings

8. Non-system electronic methods • Programs for facility inspections (e.g., InvisoSystems) • There are programs out there that you can use with an iPad or smart phone to document real-time documentation of facility and laboratory inspections • They can allow for the automatic compilations of deficiencies into a report that can be emailed to the appropriate responsible individuals • Programs for documenting review changes (e.g., SharePoint, PleaseReview) • Though use of a shared drive can also get people to see the same documents, typically only one person can make changes at a time • There are programs which can automatically track changes which, at the end of the review period, can incorporate the changes into a nicely formatted document

9. Electronic protocol development and review systems • Can be commercial or home-grown • Advantages • Complete historical record of the submissions/reviews • PI can see where in the process his submission is • Version control • Electronic signatures • Auto-population of demographic information • Pull down menus with appropriate answers • Templates for common procedures

10. Electronic protocol development and review systems • Disadvantages • Change- and this can be a significant problem depending on your institution • More technical process that typically requires more training for everyone involved • More structure and less flexibility • More complex • Periodic upgrades can create lost data • Administration is typically more labor intensive (translation: MORE WORK FOR THE ADMINISTRATOR) • If your system is web-based, and you lose web access, all work can be lost permanently • Cost- system, maintenance, license(s), etc.

11. If you decide to go with an electronic system: • BE PREPARED. It is often a case of two steps forward, one step back • Establish a selection committee composed of IACUC administrator, member, PIs, safety, IT, etc. to represent various end users • Get references from current users. This can be difficult if your institution has strict criteria for references • Do not under-estimate the need for training by IACUC administrators, IACUC reviewers, and PIs

12. What we learned when implementing a commercial system: • Need a strong relationship with your vendor • Need a champion in senior management of your institution • Listen to your vendor’s recommendations, but realize that what they might be telling you might not be fully accurate (positive spin) • Negotiate your contract CAREFULLY • Patience really IS a virtue; glitches will happen and the process will take longer than you think • Expect lack of participation from key stakeholders • Lack of depth needs to be avoided • Resistance from end-users should be expected • Again, training is key for success

13. Acknowledgements I would like to gratefully acknowledge the following individuals for their help and expertise: Marcy Brown, MA, CPIARegulatory CompliancePfizer, Worldwide Research & Development Stacy Pritt, DVM, MBA, CPIA, DACAWDirector, IACUCUT Southwestern Medical Center