One of my favorite things to do when I worked in the IRB was reporting. Not simply the “How many Protocols do we have and sort that into Full, Expedited and Exempt categories” but the kinds of queries that told you who you really were as an IRB. I’m speaking to data that helps you perhaps interpret the consistency of your decision making between multiple boards on similar projects, or workload volume vs. workload distribution vs. available expertise.
These are simply a few examples of questions that might have previously seemed too technical or time consuming to approach or were possibly never considered to begin with. Today however, with proper planning, these are answers that you can have in mere minutes. Moreover, if you spend some additional time and drop the results into a program like Excel after InfoEd extraction, you can dress up your report. And what data couldn’t use a little lipstick?
Here are several additional illustrations of the types of powerful reports that an IRB using InfoEd could develop ad hoc to truly build a Smarter eIRB.
1.) Committee Member Statistics – There are instances when we have questions such as: “Who is reviewing more often and are reviews distributed appropriately to the greatest degree possible?” Maybe the question takes the form of “For non-convened reviews, how long is it taking after assignment for those members to turn around their reviews and on top of that I need the average of those results for the last year?” Or “How many times have we had to re-assign a review because the 1st reviewer took too long and who are our repeat offenders?” This is information that in the hands of someone like a Committee Chair, allows them to more effectively lead their respective boards and get the best out of their committee members.
2.) Departmental Submissions and Committee Representation – Let’s say you pose the question “Which Departments have a greater number of submissions to the IRB and does the IRB have participation/membership from that department in a way that reflects their submission rate and consequently is their adequate expertise for these types of studies?” For example, if it’s found that 40% of submissions in the last academic or calendar year are from OB-GYN; the case can be made and probably justified that an appropriate reflection of membership from that department should exist on the committee and furthermore, the professional knowledge contributed will benefit the review process as a whole. This is yet another way of using data that exists all around you to enhance your IRB.
3.) AAHRPP Metrics – If you’re AAHRPP Accredited you’re familiar with the “Review Times by Type of Review Report,” and if you’re not it’s still an interesting and worthwhile exercise. AAHRPP requests annually that institutions query information such as Submission Dates, Review Dates and Approval Dates; apply math and detail the Mean Number of Days for several indicators such as: “Time from Submission to Review by the Convened IRB,” “Time from Submission to Approval by the Convened Board,” “Time from Submission to Review by the Expedited Procedure,” “Time from Submission to Approval by the Expedited Procedure,” and “Time from Submission to Exempt Determination.” This was always an entertaining report for me to put together because it was more than just submitting some numbers as a requirement to an accrediting body. After you complete your report and see the national results you get to ask the question; “Why does my institution fall where it does in comparison to other institutions?” If your “Time to Approval” seems significantly higher, one’s first reply might be “Well nearly every protocol reviewed at a convened meeting gets Conditional Approval so it takes longer to finalize.” Well let’s look at that. How many of the Conditional Approvals are a result of research community training and understanding? Are you offering “in-person” Introductory, Advanced and Continuing Education/Training to your Investigators? Is it the clarity in the questions you’re asking your PI’s to answer in your forms? Are you giving enough examples of what you’re looking for? Are you getting the best information the first time an investigator steps up to the plate? Or maybe it’s simply a timing issue? Is the schedule of existing meeting dates and boards sufficient to allow for a quick and timely response? Can responses be Administratively Approved versus a Convened Meeting? There are many insightful details we find when we look at the data and ask the question, well why, and if so, how can we do better?
This approach also extends into things like IRB Office FTE Statistics or the potential to go external to the IRB and share information with Clinical Trial offices or Legal offices in addition to your general compliance reporting. The key is understanding that powerful information is being captured everywhere in the system and finding a way to realize its usefulness translated beyond the obvious.
Carly Fiorina, former Executive, President and Chair of Hewlett Packard said “The goal is to turn data into information, and information into insight.” There’s something to that. My belief is that the future of efficient and Smarter eIRB’s is not only to “be electronic” but to think boldly and leverage information to benefit your overall Human Research Protection Program.