Welcome to the latest installment in our series of featured member interviews. This series highlights individuals within our membership who are making an impact on the research ethics field through their work. This month, we hear from Heather Kim, a senior regulatory compliance auditor in Quality Management for Copernicus Group IRB.
Elise Davis (ED): When and why did you join the field?
Heather Kim (HK): I had just begun my Masters in Regulatory Affairs when we covered the IRB in a basic Part 50 and 56 overview. Around that time, I was looking for an internship opportunity to gain some experience in the regulatory field and I ran across a recruitment notice for Copernicus Group IRB. I thought that working at an IRB would give me a unique angle for whenever I applied for an industry regulatory affairs position. I began working there in 2011 and was surprised and intrigued to discover a whole new aspect of the research regulatory field.
ED: What is one tool you use every day that you could not do your job without?
HK: My Outlook calendar is my most useful tool because I put everything on it – from meeting prep reminders to answering email reminders to project status reminders. My calendar lets me prioritize, re-set notifications as needed, and gives me peace of mind knowing that I can forget about certain tasks until they pop up again on my task list.
ED: What is one thing you wish the general public knew about human subjects research?
HK: Something that is the introduction for any IRB101 discussion--I wish that people realized how new the regulations for human subjects protections actually are. We take safety and efficacy trial requirements and informed consent for granted, but the Kefauver-Harris amendments were promulgated in 1962 and the Common Rule was published in 1991. There have been tremendous advances in human subjects protections in just the last few decades.
ED: What changes in the research field most concern you? What changes are you encouraged by?
HK: Instead of changes, I would say that I have been concerned about the lack of change in regulations and guidances, which are outdated and do not adequately address current issues. However, that concern is somewhat tempered by a realization that laws and regulations are meant to be difficult to change. The whole process of checks and balances and bureaucratic delays seem wildly inefficient, but the process helps weed out some unfeasible and polarizing propositions to ensure that only the changes that truly can be accepted, even if just barely tolerated, by the majority get through.
The current Notice of Proposed Rulemaking (NPRM) is a great example. It is remarkable to think about the work that went in to drafting the NPRM--the numerous revisions and compromises that had to be approved by all 15 participating agencies before being published in the Federal Register. Even after this arduous process, the proposed changes are published and open to the public for further comments and considerations, which will result in further revisions.
I suppose you could say that although it can be frustrating to see the gap between regulations and current practices, I acknowledge that the agencies are working to update rules. I am encouraged by the pending proposed rule and excited to see how the regulations will take shape.
ED: What motivates you to maintain your commitment to advancing ethical research?
HK: Different aspects of working at CGIRB help me maintain my commitment to advancing ethical research. I know that the process is working when a sponsor pulls a drug in Phase 3 because of safety issues, and I am reassured knowing the rigorous safety and efficacy tests that were required when a new drug is approved.
ED: Have there been any PRIM&R events or talks that you have attended that have made a significant impact on your approach to your work? If so, what were they and how did they influence you?
HK: I attended PRIM&R’s 2013 Advancing Ethical Research (AER) Conference and enjoyed myself immensely. I still talk about some of the panels I participated in when someone mentions they’ll be going to the conference. The keynotes from Atul Gawande and George Demetri were both really interesting and thought-provoking. PRIM&R does a great job mixing topical issues and practical, general IRB subjects with their panels and breakout sessions.
ED: How has membership in PRIM&R’s community of research ethics professionals helped you to advance in your career or do your job better?
HK: PRIM&R’s membership includes leaders from all across the research sectors and from all around the world. With such a rich membership, I appreciate that PRIM&R makes this incredible body of knowledge accessible through discussion forums, webinars, conferences, At Your Doorstep classes, etc.
Additionally, PRIM&R’s Certified IRB Professional (CIP®) program is widely recognized in the IRB realm. The CIP indicates that the credential holder has demonstrated knowledge and practical understanding of the regulations. Earning the CIP was a significant accomplishment and I know being certified has validated my credentials and will be a mark of professional distinction as I advance in my career.
Thank you for your contributions both to the research ethics field and to the membership community at PRIM&R! We are pleased to hear that our resources have been a valuable part of your professional development.
If you’d like to learn more about becoming a member, please visit our website today.