by Megan Frame, membership coordinator
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. 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 Brenda Ruotolo, who recently began a new position as executive director of the Human Research Protection Office at Columbia University in New York, NY.
Megan Frame (MF): When and why did you join the field of human subjects protections?
Brenda Ruotolo (BR): As the first of our six children started to reach their teens and endless semesters of college tuition suddenly loomed very large, my husband and I decided that we needed more stability than a personally owned small business could provide and sought outside employment. To test the unknown waters of a 9-to-5 routine, I signed up with a temporary staffing agency and was immediately placed in the institutional review board (IRB) office at Robert Wood Johnson Medical School. They were preparing for a Food and Drug Administration (FDA) inspection and were looking for extra help. I was subsequently hired as a regular employee, and remained there for four and a half years, assisting the IRB director and managing the institutional animal care and use committee. I spent the next three years at Rutgers University as the sponsored projects administrator, overseeing the IRB. While at Rutgers, I had to very quickly expand my thinking about the application of the regulations to social science and behavioral research. Early in 2003, Columbia University offered me a role as manager of a new IRB they were starting, and I was promoted to associate director of the IRB office in 2004. Throughout this process, my knowledge of the regulations and their application to an increasingly broad range of research has expanded, and I am grateful for each of the opportunities that have brought me to my current position.
MF: You were appointed as executive director of the Human Research Protection Office at Columbia. Within this new role, what are your key goals and responsibilities?
BR: My primary goal is always to maximize the protection that our researchers provide to everyone who is a participant in or subject of research. To accomplish that goal, it is my responsibility to ensure that the staff of our office are knowledgeable and invested in their work of providing support to researchers, the members of our six IRBs, and everyone else who is involved in human research protections at Columbia. We need to stay abreast of changes in regulations, official guidance, and interpretations and trends, and work as efficiently as possible to ensure that we are doing all that we can to protect research volunteers and private information about subjects. We are continually evaluating our metrics, then revamping our processes, policies, or office structure as warranted. Knowing and involving our researchers in our efforts, because we are collaborators in the research enterprise, has also facilitated a strong program. Immediately, my main objective is to fill vacant and new positions in our office, so that we can operate with maximum efficiency. Then I will consider how we may most effectively address the challenges that new technology, such as personalized medicine, and emerging trends, particularly central IRB arrangements, present for our IRBs and office.
MF: What skills are particularly helpful in a job like yours?
BR: Multi-tasking (raising six kids while managing a business has helped), being organized, knowing how to handle stress, networking, hiring the right people, and delegating.
MF: Tell us about one article, book, or document that you would recommend to individuals interested in learning more about the field.
BR: My primary go-to documents are the federal regulations at 45 CFR 46 and 21 CFR 50, 56, 312, 600, and 812. Despite being in the field for 19 years, I access these documents fairly frequently, and consult other supporting documents as necessary to help with interpretation or application.
MF: What is your proudest achievement?
BR: My children. As for my career, the fact that I was able to enter a totally new field midstream, immerse myself in learning what it was all about, and become successful at it. The fact that my efforts may contribute significantly to the safety of others is a tremendous plus.
MF: What advice would you give to young professionals who are interested in pursuing a career in human subjects protections?
BR: You can learn regulations, laws, and policies. First, however, you need to learn how to be a professional: Observe successful people, no matter what their career, to see how they manage their time, handle crises, make sound decisions, and interact with others, particularly those who are subordinate to them. Then learn about research and ethics–-volunteer, work as a research assistant or coordinator for a while, participate in or attend ethics committee meetings, presentations, or classes in ethics or disciplines in which human research is crucial. With good professional skills, knowledge about research, and a lot of energy, a career in human subjects protection will be a success.
Thank you for being part of our membership community and sharing your story, Brenda. Congratulations on your new role at Columbia University. We look forward to continuing to work with you!
If you’d like to learn more about becoming a member, please visit our website today.