Elizabeth Boyd, PhD, is Associate Vice Chancellor, Ethics & Compliance Officer at UCSF. In addition, she is the Director of CTSI’s Regulatory Knowledge & Support (RKS) program and director of RKS Consultations as part of CTSI’s Consultation Services program. In the Q&A below, Elizabeth shares her thoughts on her role as UCSF’s chief ethics officer, and sheds light on the challenges and joys of her work.
You received your postdoctoral training at UCSF’s Institute for Health Policy Studies, and served as adjunct faculty in the department of Clinical Pharmacy for five years. You returned to UCSF a year and a half ago after time at the University of Arizona. Do you have any thoughts on being back in San Francisco?
Having spent so much of my early career at UCSF, it was a great experience to spend time at another institution. The University of Arizona has a general undergraduate campus as well as a School of Medicine, Public Health, Nursing and Pharmacy so I feel like I was exposed to the whole range of issues facing universities. My colleagues were wonderful, and I learned a lot about compliance there, but my passion has always been the health sciences so it was a thrill and an honor to be able to return to UCSF.
Can you describe some of the things you’re working on in your role as UCSF’s Chief Ethics and Compliance Officer?
My first task was to reorganize the compliance units under one office – the Office of Ethics and Compliance. For many years, compliance activities at UCSF have been distributed across various units – the Office of Research, the School of Medicine, the Medical Center. My priority has been to unite and integrate these functions so that faculty, staff, and students can find the answers to their questions in one place. Integrating the compliance units also means that we can provide more efficient and effective support to investigators. I am always looking for better, more creative ways to support the research and clinical activities of our faculty.
What are some of the biggest challenges you face in that role?
By far, the biggest challenge we face is implementing the ever-increasing number of federal and state regulations on research and clinical care. New regulatory requirements are unfunded mandates – the challenge is figuring out how to meet our obligations without creating more and more work for faculty/investigators.
You’re also the director of CTSI’s RKS program, which helps researchers navigate regulatory and compliance issues required to conduct clinical & translational research, and works to advocate for improved efficiency of the regulatory approval process. Can you describe some of the issues you’re dealing with?
The exciting thing about being the RKS Program Director is having the opportunity to look critically at how we enable or support clinical and translational research at UCSF, and then ask, 'how can we do it better?' When we do things a certain way for years and years, we tend to forget that there are other ways of doing things. For instance, through UC BRAID – the five-campus consortium of CTSA’s in the UC system – we are able to think about leveraging system-wide resources and opportunities to improve our ability to do clinical and translational research. Things like the new IRB reliance MOU, which allows a single UC IRB to approve a multi-UC-site clinical study; developing a single approach to consent for biospecimen banking; a library of contract terms – all of these efforts are designed to facilitate and encourage research by easing some of the regulatory gridlock. We are also very proud of our Clinical Research Resource HUB, a comprehensive website that puts tools, templates, guidance, and advice in one place for investigators, coordinators, patients, and partners. This year, we are working on an International HUB to provide similar support for our global health researchers.
What do you like most, or what excites you, about your job…or jobs?
My job is to help our faculty do the best possible work they can – that is, enabling them to do work that is scientifically, technically, and ethically excellent. To be able to contribute in a small way to the advancement of science and health is truly exciting.
You’re also a medical sociologist and bioethicist. What originally attracted you to these fields of study?
As a sociologist, I am interested in how different social institutions are ordered and enacted through the actions of the participants. Early in my career, I became interested in clinical decision-making under managed care – how physicians made treatment decisions in a very new (at the time) social/political context. What we decide are ethical or unethical choices and practices are very much part of this same process.
What are some of the big ideas or issues that you see influencing your work at UCSF over the next five years?
Two closely related issues will shape ethics and compliance over the next few years: financial pressures and increased accountability. The federal government is increasingly holding recipients of federal funds accountable for the management of those funds – we see this in the federal RAC audits of Medicare claims, in the new Public Health Service conflict of interest regulations (requiring significant institutional oversight), and in contracts and grants reporting obligations. Because the University is also facing unprecedented financial pressures, we must find creative, efficient, cost-effective ways to fulfill our ethical and compliance obligations.
CTSI Spotlight is part of an ongoing series that offers an opportunity for faculty and staff to learn more about the wide range of people who make CTSI's work possible. See all featured faculty and staff