Each country is unique: An interview with Delia Wolf

by Avery Avrakotos, education and policy manager

This month, in honor of Member Appreciation Month, we will introduce you to a new member of the PRIM&R community each week. To start off this series, it is my pleasure to introduce you to PRIM&R member Delia Y. Wolf, MD, JD, MSCI.

Dr. Wolf serves as program director for Ethical Issues in Global Health Research: Blending Cultures, Building Capacity, and Bolstering Collaboration, a four-day course being offered at Harvard School of Public Health this June in Boston, MA. PRIM&R is a proud to offer members a discount on this educational opportunity, which strives to provide individuals involved with human subjects research with the ability to effectively conduct research outside of the United States. In advance of the course, I had an opportunity to connect with Dr. Wolf about her background in the field as well as some of the challenges presented by global health research.

AA: How and when did you first enter the field of human research protections?DW: I first stepped into the clinical research field as an investigator conducting FDA-regulated device trials in the late 1990s. As a diligent, yet regulatory naïve investigator, I spent a considerable amount of time addressing concerns and answering questions from the IRB. I felt my chance of getting IRB approval was hit-or-miss, so I decided to invest some time and energy in studying relevant regulations and their application. In 1999, I completed a master’s degree in clinical investigation, and became chair for one of the IRBs at Massachusetts General Hospital and Brigham and Women’s Hospital in Boston. Knowing what the IRB was looking for and why certain issues had to be addressed in the protocol and consent documents, alleviated my frustration with the IRB, and, in the meantime, I realized my passion for, and potential contribution to, human research protections. Later that year, I assumed a full-time position in research management at Partners Healthcare System in Boston. I was responsible for the design and implementation of a quality improvement program aimed not only at the protection of research participants, but also at assisting investigators and making compliance possible for them. To further my career, I completed a one-year fellowship in medical ethics in 2001 and received a JD in 2006. I joined Harvard School of Public Health in 2008 as the director of human research administration.

AA: Currently, you serve as the associate dean for regulatory affairs and research compliance at the Harvard School of Public Health. Within that role, what are your key goals and responsibilities? 
DW: In my current role, I serve as the institutional official for the Harvard School of Public Health and lead the Office of Regulatory Affairs and Research Compliance that oversees all human research conducted at Harvard’s Medical School, School of Dental Medicine, and School of Public Health. My ultimate goal, of course, is to protect human research participants. I would like to reach that goal by continuing to create a culture of compliance and by streamlining IRB review processes to facilitate and promote ethical conduct of research. 
AA: What skills are particularly helpful in a job like yours?
DW: Effective communication is certainly on the top of the list, but I have found that practical experience and a solid understanding of regulatory requirements are particularly helpful in this field. In my own case, the combination of my education in medicine, ethics, and law and professional experience as an investigator, IRB chair, compliance officer, and institutional official has enabled me to look at each issue from a different perspective and provide practical solutions. 
AA: In June, you will be serving as program director for Harvard’s Ethical Issues in Global Health Research course. Given your own experience in the field, what do you feel are some of the most pressing issues with respect to global health research? 
DW: I think it is critical that we consider how we apply regulations and ethical requirements in different cultures. When conducting research internationally, each country is unique, and applying regulatory requirements—especially US regulatory requirements—can impose unique challenges and create obstacles in conducting ethical research 
AA: Why did you agree to serve as the program director for the Ethical Issues in Global Health Research course?
DW: I actually inherited the course three years ago from two experts in the field: Richard Cash, MD, MPH, and Daniel Wikler, PhD. They ran the course for 11 years before I was asked to take over. In my time directing the course, I have revised the syllabus to focus more on the practical issues encountered in global health research. We have individuals with diverse backgrounds attend, and we strive to provide advice and tools that can be used by those responsible for reviewing, approving, conducting, and/or monitoring research. We’ve received positive feedback about our approach. 
AA: What is one recent article, book, or document that you would recommend to individuals interested in learning more about global health research?
DW: In the course, we rely on reading material from a number of different sources. Many of the case studies we use, however, come from Casebook on Ethical Issues in International Health Research, which was edited by Cash and Wikler, as well as Abha Saxena, MD, and Alexander Capron.
AA: What motivates you to maintain your commitment to advancing ethical research?
DW: I am motivated by the fact there is still much to be done – striking a balance between ensuring regulatory compliance and streamlining research review processes is just one of the continued goals. It is not an uncommon belief that stricter review processes result in better compliance, but that is not necessarily the case. “Less is more” is becoming a new approach to minimize regulatory burden and maximize compliance, but this shift in thought requires a great deal of expertise, education, and commitment.
AA: What advice do you have for young professionals interested in pursuing a career in human research protections?
DW: Be enthusiastic and knowledgeable. A solid understanding of the ethical and regulatory requirements for human research is essential, and keeping up with current developments is challenging. There is a difference between doing a job and pursuing a career. For example, an IRB reviewer may rely on existing tools (e.g., checklists) to do his/her job, but if you want to advance your career in the area of human research protections, the goal should be a clear understanding of what’s on the checklist, where the requirements came from, and how to apply those rules. Going above and beyond requires enthusiasm, dedication, and discipline, but it’s the shortcut leading towards proficiency, with which, you’ll be able to fully appreciate the excitement of our profession. 
Thank you for being part of the membership community and sharing your story, Delia!