by Avery Avrakotos, Education and Policy Manager

On Monday, October 14, Elyse I. Summers, JD, assumed the role of president and CEO of the Association for the Accreditation of Human Research Protections Programs, Inc. (AAHRPP). Ms. Summers has been a devoted member of the human subjects protections field for nearly 15 years, having served most recently as the director of the Division of Education and Development in the Office for Human Research Protections (OHRP). Ms. Summers has also contributed her talents to PRIM&R over the years as a dedicated member of our conference faculty and co-chair in 2012 and 2013 of the Workshop/Didactic Sub-Committee at the annual Advancing Ethical Research Conference. In the midst of her first week at AAHRPP, Elyse sat down with us to reflect on her new role and her commitment to the field of human subjects protections.

Avery Avrakotos (AA): When and why did you join the field of human subjects protections?
Elyse Summers (ES): My first professional job at the Association of American Universities, which represents leading research universities in the US and Canada, was my first exposure to the research enterprise broadly. During that experience and subsequent positions at the Food and Drug Administration (FDA) and a boutique FDA law firm, I ran into issues related to human subjects protections that I found fascinating. The goal of respecting and supporting the volunteers who make the research enterprise possible was very appealing to me on both an ethical and personal level. At the FDA, I also had the opportunity to participate in a group involved with rewriting the regulations at 45 CFR 46 Subpart B, which relate to the participation of pregnant women, human fetuses, and neonates in human subjects research. The whole topic of women’s participation in research, including the issue of respecting women’s autonomy and their ability to make decisions about research participation, was very appealing to me as well.

AA: What motivated you to become involved with AAHRPP?  
ES: That is a very timely question. While I really enjoyed my work at OHRP, I was starting to see some of the limitations with respect to what a person can achieve from within the government sector. I was ready to explore other avenues for bringing to bear some of my skills in the support of human subjects protections. More broadly, since as I speak today we are in the midst of the federal government shutdown, I am seeing and valuing even more the importance of organizations such as AAHRPP and PRIM&R working in parallel with—but independently from—the government to ensure that people are properly educated and committed to robust human research protection programs.

AA: What are your key goals as president and CEO of AAHRPP?
ES: I think of this as an opportunity to begin “AAHRPP 2.0” and to help bring AAHRPP well into the 21st century by expanding the body of organizations that understand that AAHRPP accreditation is an accessible but rigorous process that can bring value to all stakeholders in research. Another major goal is to really reconnect AAHRPP with its founding members—including, of course, PRIM&R, plus, the Association of American Medical Colleges, the Association of Public and Land-Grant Universities, the Consortium of Social Science Associations, the Federation of American Societies for Experimental Biology, the National Health Council, and the Association of American Universities. I think our strength as a non-profit, educational organization, and ultimately our strength in helping to protect human subjects, comes in part from close ties and collaborations with other organizations that worry about the same issues and take them very seriously.

AA: Can you tell me about an article, book, or document that has influenced your professional life?
ES: The Belmont Report has been very influential to my professional life. Fairly or unfairly, I think people tend to think of issuances from the federal government as documents that end up on a bookshelf collecting dust. However, The Belmont Report in its eloquence and relative brevity has stood the test of time in its articulation of the three principles of respect, beneficence, and justice. While The Belmont Report stands as an important foundational text, it also remains a very dynamic and living document. For instance, the notion of justice used to be thought of strictly in terms of protection from the costs and risks associated with research. Since the mid-80s and the emergence of the HIV/AIDS pandemic, members of advocacy groups have shifted their perspectives and have recognized that research might also be a source of hope and benefit. Thus, the notion of justice as embodied in The Belmont Report has been expanded to include weighing both the burdens and possible benefits of being a research subject when determining who should be recruited to participate.

AA: What motivates you to maintain your commitment to advancing ethical research?
ES: The issues that we grapple with everyday are interesting and compelling. I feel very fortunate to work in a field that has as its centerpiece such a laudable and noble goal, which is to protect the rights and welfare of people who volunteer their time and energy to, in turn, make the world better for others.

AA: What do you consider to be the most challenging ethical issues facing human research protections professionals today?
ES: With regard to human research protection professionals, one challenge that I think we all face is doing more with less. I think that as professionals in the field we can feel pressured to move things along or cut corners. However, I believe it is essential for us to remain steadfast and vigilant so as to not compromise our own convictions about what is right, as well as our understanding of what is right  in terms of our organizational roles and in terms of the ethical and regulatory principles that govern human subjects research.

AA: What advice do you have for young professionals interested in pursuing a career in research, research ethics, or a related field?
ES: I would advise people interested in the field to try to get a sense of the landscape and find a way in through a field or profession that is comfortable to them. One of the things that I love about our community is that it has attracted so many people with rich and diverse backgrounds. I am a lawyer by training—I always wanted to be a lawyer—and I am happy I became a lawyer because I think that type of study—in addition to the rigor and the analytical thinking necessary for it—was something that was comfortable and natural for me. I have been happy to be able to bring these skills to bear in my role as an educator, working in compliance, and now in this position as president and CEO of AAHRPP. There are so many different courses of study—whether it be ethics qua ethics, public health, medicine, law, social work, nursing, to name just a few—that can bring a person to human subjects research, and as a field, we are blessed to have organizations such as PRIM&R, with certification programs such as the Certified IRB Professional (CIP®) where, regardless of a person’s particular educational background or degree, they can learn and become a professional in human subjects protections.

Thank you for taking the time to speak with us, Ms. Summers. We look forward to working with you in your new capacity as president and CEO of AAHRPP!

If you are interested in learning more about Ms. Summers and her vision for the future at AAHRPP, we encourage you to read a recent interview with her from the AAHRPP Advance or follow her on Twitter @eiceoaahrpp.