Article: Journey to Becoming a Certified IRB Professional (CIP)

Kimberly A. Hawkins, BA, CIP, Regulatory Associate
University of Texas Southwestern Medical Center (UTSW)

I was hired as an administrative assistant in UTSW’s IRB in 2010. While I had a strong background in administration, I was unfamiliar with the research world, including the IRB. However, it quickly became clear that this was not only a world I wanted to know more about, but that was also a place where I could see myself staying long-term. 

Since that time, I have moved from an administrative role to regulatory assistant, where I work with IRB chairs to process modifications. I have found that this type of submission allows me to become familiar with multiple types of research, whether minimal risk or more than minimal risk and many kinds of changes (e.g., protocols, consent forms, recruitment materials, etc.). While I was serving as a regulatory assistant, I experienced the IRB before, during, and after our institution’s conversion from paper to electronic submissions. I was grateful to witness the transition because it was such a dramatic shift in the way that reviews are conducted. I also started to manage the IRB training database, which has helped me understand that aspect of educational compliance. 

About a year and a half ago, I was promoted to regulatory associate. In that role, I now review new exempt and expedited studies and continuing reviews. I am finding that beyond the rote processing of paperwork lies the fascinating world of the Federal regulations and guidance, the Belmont Report, the Nuremberg Code, and institutional and IRB policies. With every new review comes the challenge of balancing ethics with applicable regulations, guidelines, and policies, so that the underlying goal of protecting the rights and welfare of human research subjects is achieved. I have also found that it is a challenge to conduct substantial reviews in a timely manner. To address this issue, I have been coordinating the development of detailed review checklists for expedited reviews and updating them as changes arise. 

Two years ago, I became interested in taking the CIP exam and purchased Institutional Review Board Management and Function: Second Edition, a book by Elizabeth A. Bankert and Robert J. Amdur, as well as the corresponding study guide. My manager helped pave the way for me to take the CIP exam, as he had our entire department study the book together. After that, three of my senior colleagues took and passed the exam. Seeing their success, as well as how their knowledge of the regulations helped answer difficult questions, I decided to commit to taking the spring 2015 exam. 

My manager once again helped by setting aside a one-hour tutorial session for anyone who wanted to study for the exam and for new employees that had not yet reviewed  the book. Additionally, one of my senior colleagues heard about Felix Gyi Memorial CIP Scholarship at PRIM&R’s annual AER conference. I decided to apply, and was honored to receive the scholarship, which enabled me to move one step closer to my goal of becoming a CIP. 

Looking back, the most helpful study methods for me were the in-house study sessions at my institution; an online Facebook group called, “Certified IRB Professionals (CIP) Study Group;” answering study questions from the study guide; and taking practice exams. The other thing that helped was using Dropbox to download as much information as I could onto my iPad, so that I could study whenever I had a spare moment. 

If I was going to offer advice to someone contemplating taking the exam, I would echo what I was told: that the exam is on the regulations, not on your institutional policies. It can be easy to get that confused, so it is important to remember and appreciate the differences. Also: study hard and answer as many practice questions as you can. In the end, this is work you do every day. You may not get every question right, but you don’t need to. Just do the best you can and don’t get too stressed. I think the thing that helped me the most in terms of stress was deciding to bring a cake to work when I got my results. If I passed, it was going to be a celebration cake, and if I didn’t, it was going to be a commiseration cake. Either way, I would have my team’s support. 

I have just joined PRIM&R’s Mentoring Program and will be speaking with my mentor soon. I am looking forward to learning from an experienced IRB coordinator and hope someday to return the favor and become a mentor to someone else. I am excited to see where the future will take me as a CIP.