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

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 detailsMake 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 IACUCTry to make it as easy as possible for the PI

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??

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

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….

Go ElectronicCan 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”

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” accessTypically 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 signatureAccepted by most agencies (OLAW, USDA, NIH, etc.)

Web-based sign up services (e.g., Signupgenius.com)Can be used for facility inspections and meetings

Non-system electronic methodsPrograms 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

Electronic protocol development and review systems

Can be commercial or home-grown

AdvantagesComplete historical record of the

submissions/reviewsPI can see where in the process his submission isVersion controlElectronic signaturesAuto-population of demographic informationPull down menus with appropriate answersTemplates for common procedures

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.

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

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

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