30
May2014

by Megan Frame, membership coordinator

This month, in honor of Member Appreciation Month, I will introduce you to a new member of the PRIM&R community each week. We’ll learn about their professional experiences, personal interests, and, of course, what keeps them committed to advancing ethical research. This week, it is my pleasure to introduce you to Eva Pastor, CIP, IRB manager at Allina Health in Minneapolis, MN.


Megan Frame (MF): When and why did you join the field?
Eva Pastor (EP): I stumbled into IRB work; I had been working in clinical research for twelve years with roles in clinical operations, project management, and business development at a contract research organization. Through this work, I was exposed to IRB review processes and informed consent documents, and I was drawn to the whole concept of the IRB and its mission. In 1999, I was a single mom with two children under the age of four, and I was the assistant director of proposals and contracts for Covance Periapproval Services, which was a demanding position. I needed a change. Coincidentally, a position as manager of St. David’s Human Research Review Board (HRRB)—a “commercial” IRB managed by Covance—opened up, and I applied, was offered, and gladly accepted the position. That was the start of some of the most rewarding years of my professional career.

MF: What is your proudest professional achievement?
EP: Shortly after starting in my position as manager of St. David’s HRRB, we began serving as the IRB of record for a very large (3,500 sites) phase IV study. It quickly became apparent that our home-grown Microsoft Access database system, which was central to all IRB activities, wasn’t functioning properly. It wasn’t developed to handle that much data. The person who had developed the system had left the company years ago and had not left any documentation. Our wonderful IT staff did their best to remedy the issue, but, as I like to say, they were putting Band-Aids in one area, while the system was hemorrhaging in others. I made the decision to abandon the system and move to Microsoft Excel and Word. For seven years we used that rudimentary system to track all submissions, create agendas, meeting minutes, IRB correspondence, site-specific consent documents, and site status reports at the time of continuing review. It was not a fancy solution, but it worked!

MF: Can you name one or more articles, books, or documents that have influenced your professional life.
EP: I’ve developed a fascination with the history of human subjects protections and have amassed a small library on the subject. To name just a few:

Reading these books is a strong reminder of how without regulations and oversight, humans are capable of doing horrible things to each other.

MF: How has membership in PRIM&R’s community of research ethics professionals helped you to advance in your career?
EP: The PRIM&R community has been instrumental in my career. Attending the conferences has given me an opportunity to meet other IRB professionals and compare notes on how we do things. More specifically, PRIM&R’s Primer on the Advance Notice of Proposed Rulemaking was a valuable webinar that outlined key proposed changes and made it much easier for me to discuss the proposed regulations with colleagues and clients alike. Another webinar, Convergence of Biomedical and Social/Behavioral Research: Implications for IRBs and Investigators, laid the foundation for my eventual involvement with social/behavioral research.

MF: Is there anyone, living or dead, who has inspired you in your career and/or in life?
EP: The story of Jesse Gelsinger has been an inspiration to me. For a young man to enter a clinical trial for purely altruistic reasons is nothing short of inspirational. Discovering the issues surrounding his untimely death was shocking. His death really drives home the importance of full disclosure of conflicts of interest and prior study results.

MF: What is one thing you wish “the person on the street” knew about your work?
EP: Just the fact that IRBs exist, and the importance of the work we do.

Thank you for being part of the membership community and sharing your story, Eva. We appreciate your reminder of the story of Jesse Gelsinger, and others like him, who inspire our work.

If you’d like to learn more about becoming a member, please visit our website today.

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