By Maeve Luthin, JD, professional development manager
Welcome to another installment of our featured member interviews where we introduce you to our members—individuals who work to advance ethical research on a daily basis. Over the course of the past few months we have been shining a spotlight on members of the Certified Institutional Review Board (IRB) Professional (CIP®) and Certified Professional IACUC Administrator (CPIA®) Councils. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind the scenes in their lives!
Today we’d like to introduce you to Lori Roesch, senior IRB administrator at the Milwaukee VA Medical Center.
Maeve Luthin (ML): When and why did you join the field?
Lori Roesch (LR): I unknowingly joined the field in September 1995, before the human subject protections profession was so well-defined. At that time I had been promoted from medical secretary to administrative assistant for the director of research, who also happened to be the IRB chair (which today would be considered a conflict of interest). I had experience coordinating our IACUC, which qualified me for the promotion. Without formal training or orientation, I “inherited” a 150 protocol IRB, to which 10 percent of my time was allotted. This IRB had undergone an FDA audit in February 1995 and was issued a “483” with three violations. One of my first duties was to send correspondence on behalf of our IRB chair to both OHRP and FDA—I had no idea what that meant! I didn’t realize it at the time, but this was an opportunity to join a growing and developing field. I became a member of a community of committed and engaged human subject protections professionals.
ML: How did you become involved with PRIM&R?
LR: I attended my first PRIM&R conference in 1999, which was incredibly eye-opening for me. Being relatively inexperienced, and having had absolutely no training, I had no idea what I didn’t know. This was also at a time of great uncertainty for human research protections programs (HRPPs), as OHRP was shutting down very prominent organizations. I attended a session presented by an individual from one of the institutions that had experienced a shut down. He gave a frank and open presentation on “what not to do” and provided suggestions to help other organizations avoid experiencing a similar situation. When I returned from the conference, I was able to identify many things we weren’t doing well either— we weren’t alone. That began my journey of “continuous quality improvement” and motivated me to help our organization pursue and achieve accreditation, first from the Partnership for Human Research Protection (PHRP) and later from the Association for the Accreditation of Human Research Protection Programs, Inc (AAHRPP).
ML: What prompted your interest in joining the CIP Council, and why did you agree to serve?
LR: Since I had seen the development and growth of the credential, and the CIP has meant so much to me, as one of my proudest professional accomplishments, I welcomed the opportunity to “give back” in support of its important mission to promote the field of human subject protections.
ML: How has the credential advanced your career?
LR: I’m one of the “Cinderella” stories of the IRB world—I was in a clerical position, responsible for IRB work, and then grew into a position responsible for the direction of the HRPP at our organization.
I took the first ever CIP exam, which was administered in October 2000 during the annual PRIM&R conference at Paradise Point Resort in San Diego , CA. I remember it like it was yesterday—I was in a room with approximately 80 other individuals, and I was so nervous. I was also nervous when I received my test results. I couldn’t open the envelope in front of anyone in case it was bad news—fortunately, it wasn’t!
Successfully passing the CIP exam helped illustrate for my organization that I have a strong knowledge base and gave them the confidence to promote me from administrative assistant to IRB manager. Today I am director of our program. Having the certification, I believe, has shown my organization and others that I have a working knowledge of complex human subject protection concepts. Of course, certification alone doesn’t guarantee that one can do the job well, but it’s an objective measurement.
ML: What skills are particularly helpful in a job like yours?
LR: Knowing how to research and find answers to the myriad of complex questions that come up on a daily basis is critical. Even those who hold the CIP credential do not always have the answers. The most knowledgeable IRB professionals I know admit they do not know everything, and do not trust their memory but rather go to appropriate sources for answers.
ML: Tell us about an article, book, or document that influenced your professional life. Or, tell us about a recent article, book, or document that you feel is particularly relevant to the field.
LR: Of course, the Amdur/Bankert Institutional Review Board: Management And Function. It was and remains extremely beneficial to anyone in our field. I remember the first year the book was published: I spent New Year’s Day reading it (yes, I’m one of those IRB people). For the first time I felt validated that I was moving our organization’s HRPP in the right direction.
ML: What advice have you found most helpful in your career?
LR: Don’t be afraid to ask dumb questions of knowledgeable sources, including the “feds.” Also, don’t just implement something because someone told you to do it, but rather be sure you understand the concept fundamentally so you can assess if the change is right for your program and you can implement the change appropriately.
ML: What is your proudest achievement?
LR: Professionally, in addition to attaining my CIP, my proudest achievements are helping our organization’s HRPP successfully achieve both PHRP and AAHRPP accreditations and becoming an AAHRPP accreditation site visitor.
ML: Is there anyone, living or dead, who has inspired you in your career or in life?
LR: Jeff Cooper, Scott Lipkin, and Marjorie Speers, who have always been so gracious and willing to answer my dumb questions and help me grow and learn (I aspire to one day be half as knowledgeable and accomplished in human subject protections as they are). Equally, our previous HRPP director/IRB chair, is both a personal and professional mentor who helped me work through both our local IRB’s ups and downs and our continuous quality improvement efforts between 1998 and 2011.