After five and a half years in research administration, I felt it was time for a tune-up.
I have observed that the day-to-day grind of the job can be taxing and strain even the seasoned administrator. There is also a need to remain vigilant against the casual drift towards complacency in protecting human subjects. So, I was delighted to learn that PRIM&R’s IRB Administrator 201 was coming to a city near me.
In addition to getting a refresher on the regulations, I was eager to hear about some of the IRB methods, practices, and tools employed at other institutions. What strategies are most conducive to effective IRB administration? Which skills do I personally need to develop or hone to better perform my job in serving the needs of investigator, institution, sponsor, and the subjects we are charged with protecting? The regulations governing human subjects research apply to all institutions who receive federal funding, yet there are multiple and diverse routes to addressing them.
Fittingly, in the opening session, we were introduced to the KISS framework for analyzing the everyday IRB questions and issues encountered on the job. In each scenario, we must be knowledgeable about the issues, implement effective strategies for assisting our investigators and IRB members, and possess the appropriate skills. At my institution, we typically begin each review with a general application checklist to identify items that are missing or require attention. I am a huge fan of checklists; they were my go-to resource early on, as they helped fill critical knowledge gaps and avoid the obvious errors a new administrator might be prone to making. Representative of a much broader scheme, KISS forces me to more actively consider, utilize, and sharpen other competencies essential to IRB review, which ultimately results in a smoother and more comprehensive review process. Another topic covered during the session was attention to soft skills such as listening, patience, and interpersonal communication and the important role that these play in our work. Although these qualities are not widely touted, they are certainly critical to performing our jobs well.
In applying KISS, one sage piece of advice borrowed from Jeff Cooper of WIRB Copernicus Group is to ask the right questions in order to get the right answers. As IRB administrators, it is imperative that we ask relevant questions in order to receive the information that will accurately inform our assessment of the issue so that we can then provide the appropriate guidance. Certainly, even a well-informed administrator is ineffective if the knowledge is misapplied.
On a more micro level, we were encouraged to use the step-wise process to evaluate IRB requirements for a proposed activity. This very simple process requires that we consistently assess each activity in following order:
- Is it research?
- Are human subjects involved?
- Is it exempt from IRB review?
- Can it be expedited?
- Is full board review required?
By applying the step-wise process, I can avoid expending considerable time and effort on making a human subjects determination if in fact the activity does not qualify as research. As I reflect on my own experiences with premature assessments, this discussion served as a timely reminder (or warning) to take a more careful and methodical approach to my work.
As we know, the regulations are not always clear-cut and are sometimes misinterpreted, which can complicate the job of evaluating the research they govern. With such complexities, I appreciate the utility and simplicity of KISS and the step-wise process.
Finally, one practical and fun aspect of the course was the case study review, which allowed us to test our understanding and application of these approaches and receive real-time feedback from the course instructors. By the end of the session, I definitely felt recharged.
Mukesha Voltz is an IRB Administrator at the University of Alabama. She attended PRIM&R’s 2016 IRB Administrator Boot Camp in September as a member of the Blog Squad. This post is her follow-up on the event.