I recall several years ago getting ready to work on my first InfoEd implementation. I was hired to be this Regulatory Compliance /IT/Accreditation “Guy;” later affectionately dubbed the “InfoEd Guru.” It was my first time working with the software, yet I was eager and downright giddy. I was however, immediately introduced into an absolute “DMV” of a process. Literally, long waits, disgruntled customers and the feeling of nonsensical, governmental bureaucracy. Can you guess which office I was implementing for? (Insert guilty smile here.) Unfortunately nearly every IRB gets this wrap. No matter that since 2008 the numbers of FTE’s as well as budgets for IRBs have gone down while the number of active Protocols has continued to rise.1 Or, that just in the last 2 years IRBs have begun to play an ever larger role in the evolving world of Conflict of Interest. Not to mention standard gate-keeping issues like health record privacy, methodological soundness, and scientific merit. I digress.
So here we were as nervous as any intuitional office might be when rolling out a system, particularly when we weren’t the favorite son. The general consensus was that the backlash would be tremendous and the progress we were working towards would be cut short before we were even live. There was however a hold-out, a gentleman that saw our struggles differently. He’d later become my boss and mentor. He said to me “Phillip, this is the Opportunity to help one of our less admired program offices turn the corner.” He and I partnered up and our philosophy became simply, “if we can contribute to just one more award or one more discovery…” In our minds we were the quietly mentioned, unsung heroes…the faithful few. We would press this line of thought in everything we did and it would later become contagious!
At the time, what we were trying to do at our institution was unprecedented and we had no idea that we were on the precipice of something truly remarkable. Our focus became customer service. We allowed our research community to comment and rate the system that was being rolled out. When they had issues we walked to their offices and had in-person sit-downs to truly understand the breadth of their situation. They had our cell phone numbers and email addresses and knew that they could call us at any time for assistance. We built allies, we renewed trust and we were now partners. Success, however you wanted to define it, was a shared journey. The road started off lonely but eventually our efforts proved fruitful.
Our group introduced regular research community surveys, new avenues for research education and greater levels of IRB transparency. As new leadership came into the IRB we continued to push forward. Introducing a regular newsletter for the research community, research focus groups that spoke to IRB processes and finally many new reforms centered on strengthening our investigators as well as our HRPP. At this point the message was clear, along with facilitating the review process we were not only assisting our Investigators but also serving our research subjects, the end goal of any IRB.
Amazingly, this came out of the implementation of a new electronic IRB submission module. It would however turn into a fundamental shift that began four years ago and continues to this day. The nimble, evolving, quality-driven IRB was born. Our labors eventually saw gains in efficiency, an improved process, a focus on reducing risk and a realization for our research community that IRB Staff and Members are in fact colleagues with much experience and guidance to offer.
The idea of collaboration and the shear concept of allowing individuals to have a say, goes a long way to building bridges. Implementation turned out to be an excellent catalyst to drive a new alignment with our research community. For you the jumping off point might be AAHRPP Accreditation, an FDA audit or simply recognizing the fact that it’s time for a new business model. When we live in our own silos partitioned from the “real world” and conducting business in a vacuum we miss so much. Yes, IRBs have a mandated and regulated job to do but each institution determines the approach to achieving its required goals.
Customer service, communication and education driven by quality improvement can help to move an organization towards the kind of acceptance and relationship at an institution that pays dividends for years to come. The seemingly gail-force winds of change are ever-present, and although we might not be able to alter the direction of those winds; we can always adjust our sails and let the drafts of Opportunity push us towards something greater, something more meaningful.
Speers, M. A. (2012, December). IRBs Meet Today’s Research Challenges with Increased Efficiency, Emphasis on Quality. The Monitor, 26, 11-13