By Ksenia Lyon, IRB Senior Research Protocol Analyst
When new acquaintances ask me about what I do for work, I initially respond with another question: “Have you ever heard of an ‘institutional review board’?” Most of the time, the answer is “no,” so I go on to explain it somewhat like this: an entity that conducts research with human subjects, such as Emory, is required to ensure the rights and welfare of research participants are protected; thus, proposed research projects must be reviewed by the IRB, whose expert members (scientists, non-scientists, and lay community members alike) must weight scientific and ethical considerations and determine whether studies can proceed.
Lest my conversation companion falls under the impression that I am some powerful individual who decides what research will be done, I go on to clarify that I am not an IRB member, and do not greenlight studies. The IRB functions with administrative staff, and my job is to conduct preliminary reviews and processing. As a research protocol analyst, I work with study teams to help them bring their submissions in line with regulatory and institutional requirements so that by the time the IRB members review them, any administrative issues and submission errors have been resolved.
While the above sums up my typical explanation of my job—and approaches the limit of most people’s capacity to follow along in a casual conversation—besides research protocol analysts like myself, there are different IRB staff roles who perform other functions toward the mission of protecting human research subjects.
The Education and Quality Assurance (QA) Team, led by Shara Karlebach, performs broad oversight functions, including processing reports of research noncompliance and adverse events (and working with IRB members to adjudicate mitigation plans when appropriate); reviewing conflict of interest management plans; and providing IRB education and outreach to the Emory research community and IRB staff and members, among others. The Education and QA Team is also responsible for tracking and managing internal IRB noncompliance, encouraging continual performance and process improvements. Carol Corkran has the important role of overseeing the IRB membership’s needs – our Committee of over 80 faculty, staff and community members needs frequent tending.
The Reliance Team, led by Julie Martin, is responsible for assisting Emory researchers with fulfilling the administrative requirements of collaborating with external personnel and institutions. Whenever study teams wish to add non-Emory personnel to work on their studies, an Emory investigator joins another institution’s research project, or a multi-site research project involves coordination with and review by a single IRB (whether Emory or an external IRB), the Reliance Team shepherds these processes so that investigators at Emory and beyond can work together on the important studies they are conducting.
Our IRB staff performs these important functions under the direction of our capable Leadership Team, who keep the IRB office running by overseeing our work and providing much-needed guidance to our staff. They also interact with other offices across ORA and represent the IRB to the broader Emory research community, ensuring that our staff are specialized but not siloed. Together, the roughly two dozen individuals at the IRB are proud to work together and within ORA as part of the well-oiled machine that enables Emory researchers conduct their groundbreaking work!