Giving Back to the Human Community: An Interview with Carole Ehleben

By Nora Murphy, membership assistant

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. During May, Member Appreciation Month at PRIM&R, we are featuring a new member interview every week! Please read on to learn more about Carole Ehleben, EdD, senior partner at Consultants for Evaluation and Applied Research (CEAR).

Nora Murphy (NM): When and why did you join the field?
Carole Ehleben (CE): By way of background, I’m the senior partner and owner of Consultants for Evaluation and Applied Research (CEAR), a private consulting company. It’s through CEAR that I’ve been a part of the IRB world. I’ve helped establish several new IRBs and worked with existing ones to review standards of function and compliance. Among other roles, I’ve served as IRB administrator for both a public and a private hospital system since the 90s. I entered the field at a time when it was developing and expanding, and initially became involved because of my background in project development and clinical research—there weren’t actual job descriptions for IRB staff then.

NM: What’s one specific challenge that you have faced during your career, and how did you overcome it? 
CE: The most difficult part of establishing an IRB when I started was getting buy-in from the physician investigators. Up until that point, with the exception of large academic institutions, clinical research was largely unregulated in community hospitals and private practices. We achieved buy-in by involving the investigators in every part of the process— helping them develop their proposals and consent forms, having them present and participate in discussions at meetings, and providing training. We demonstrated that conducting ethical research not only protected subjects but the investigators as well, and could even improve the research being conducted.

NM: What is one thing you wish the general public knew about human subjects research?
CE: I wish the public understood that ethically and scientifically sound, well-conducted studies are the best way of establishing and advancing medical knowledge, which is in everyone’s best interest. Persons volunteering to be subjects are critical to this process and are giving back to the human community.

NM: What is something you know now that you wish someone had told you when you first entered this field?
CE: The best IRB members are volunteers—not conscripts.

The most engaged and involved volunteers are there because they understand the value of the role the IRB plays in the research enterprise and want to be a part of it. These willing participants bring a level of energy and commitment to their service that cannot be administratively mandated.

NM: What changes in the research field most concern you? 
CE: The trend towards centralized IRB review concerns me. There are several valid arguments for why such a process should be in place—consistency, elimination of redundancy, guaranteed expertise—but speed of review in the absence of demonstrated concern for subject safeguards is not one of them. Since the potential for harm is greatly expanded with a centralized process, the need for transparency and oversight becomes even more critical.

NM: What motivates you to maintain your commitment to advancing ethical research?
CE: It remains a field where I can make a difference in a very real and immediate way to all those volunteers who are helping advance clinical science.

NM: How has membership in PRIM&R’s community of research ethics professionals helped you to advance in your career or do your job better? 
CE: When I started, very few people knew much about what IRBs did and how they worked. PRIM&R was a community of people who became teachers, colleagues, resources, advocates, and friends; people working towards a common goal of improving research protections—not always agreeing, but providing a forum for ideas and practices to be discussed and tested. It was very exciting and motivating to be part of that. It still is.

Thank you for being part of the membership community, Carole! We are glad to hear that the PRIM&R community has been a benefit to you over the years.

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