Longtime IRB committee member and Mission Bay chair, Gordon Fung, MD, PhD, MPH, has taken on a role to lead a newly formed cardiology-focused panel that will support studies across a wide and growing range of cardiology sub-specialties.
Fung serves as a clinical professor of medicine, leads an active clinical practice in consultative general clinical cardiology, directs the nation's first UCSF Asian Heart & Vascular Center, and has extensive clinical research experience that has informed his long tenure on the IRB committee.
Along with a rich history at UCSF, which started in medical school, he also has a deep passion for advancing the institution’s clinical research and protecting its study patients.
We asked Gordon a few questions about his time on the IRB, the new cardiology-focused panel, and how recent IRB improvements are leading to faster and more effective clinical trial activation.
You have recently been selected as the chair of a new Cardiology-focused IRB panel. How would you describe the goal of this panel and the need it is filling for the research community?
The cardiology-focused IRB panel has been formed after years of growth in this focus area—with not only an increase in cardiology faculty but a growth in specialties within the focus area.
While the cardiology group was initially focused on advanced interventions and electrophysiology, there is a growing number of sub-specialties including adult congenital heart disease, cardio oncology, advanced heart failure, cardiomyopathies, pediatric cardiology and cardio obstetrics. As the cardiology group grew, the research interests grew as well, and so we've been doing a lot more studies that are much more complex.
Even as we tried to get more cardiologists involved with all the separate IRB committees, there just weren't enough of us to go around. By gathering cardiologists to serve on a focused IRB panel, while representing this variety of growing sub-specialties, we can better support this growing field of research at UCSF.
What are you most excited for regarding this new role?
It’s exciting to learn more about all the advances we are making across these cardiology sub-specialties. I am also enthusiastic about the improvements we can make to the research process, especially regarding clinical trial activation process and shortening the time it takes to get cardiology studies approved. I know this is an area that the IRB and Office of Research are working on through the Clinical Trial Excellence Campaign (CTEC) and I am excited to see how we can make study approval quicker and more seamless by engaging with investigators.
What have you found to be most fulfilling or impactful about your nearly two decades spent on the IRB?
One of the most important things is the evaluation of the risk when it comes to looking at it from a patient's standpoint, including how we present the information and how we try to minimize risks so that the patient is completely aware of what is going on.
So many of the terms that we use in consenting information are very complex. We used to have consent forms that were 10 pages long, and now they're like 30-40 pages routinely, and most of it is filled with risk information and other things aside from the studies, so it becomes quite a daunting task.
How we can explain that to patients so that they can understand this information is an entirely new area of managing patients in addition to collecting information to learn more about the disease itself. That's where I think we can be most impactful to make sure that the patients and everybody involved are aware of the risks, and that we're going in with eyes wide open.
The IRB can support researchers to think about the patient perspective as they navigate these risks. A recent major IRB effort resulted in the release of a Plain English Consent Form template that we developed specifically to better inform research participants of what will happen to them during the course of the study, and what risks they will be assuming by participation, in language that is much more participant friendly.
What would you like researchers to know about working with the IRB?
I know that working with the IRB committee can sometimes seem like a burden, but our main goal is to work collaboratively with the research team to ensure that the patient is adequately protected and that there’s no perception of conflict of interest.
We want to support the researcher and move things along as best as possible. I like working with the PI early in the process to address potential issues prior to the formal review and encourage engagement and discussion to think about the study from all various standpoints. We’re here to help PIs look through that patient-focused lens.
How would you describe the importance of the IRB within the UCSF community?
Because the UC is well known for its outstanding scientists and researchers, we need to do our best to ensure that everything is done ethically, at lowest risk, and without conflict. I think it’s important for the community at large to be aware that the IRB is involved in all aspects and types of research, and that if we continue to keep patient safety in mind, our research will continue to be of its highest caliber.
If you want to learn more about participating on the IRB, please contact [email protected].