I have been at UCSF for my entire career, and I started in the field of cancer research when UCSF had a small oncology program. We now have nearly 100 faculty and 15 faculty in the GI Group which I lead.  Early on, I did general oncology, and at the time UCSF was looking to rejoin the National Cancer Institute cooperative groups. I was one of the faculty who got really involved in these cooperative groups many years ago.

Over the years, I have been involved in various aspects of cancer research, particularly focusing on gastrointestinal (GI) cancers.  I have had the opportunity to help design and lead studies mostly in colon and hepatobiliary cancers and I also chaired the GI Committee within the Alliance cooperative group, which afforded me the chance to work with investigators across the country.

Initially, my involvement with the IRB was somewhat reluctant. Like many researchers, I saw it as an additional bureaucratic task. However, I accepted the importance of representing my department and ensuring that research protocols were ethical and well-designed. Over time, I found the work surprisingly interesting and enjoyable. My interest in the IRB grew, leading me to chair a cancer-centric IRB committee. I have now been involved with the IRB for more than a decade, stepping down for a period but returning because I believe it is an area where I can make a contribution.

Complex study designs, particularly in fields like oncology, present unique challenges for the IRB. Our primary focus is on patient protection and ensuring that the risks of participation are outweighed by potential benefits. With studies involving treatments like CAR T-cell therapy, there are numerous considerations, such as patient understanding, risk mitigation, and ethical implications. We often spend considerable time understanding the nuances of these studies and ensuring that patients are fully informed before consenting to participate.

Balancing patient protection with research advancement is a delicate task. While we strive to facilitate research, our primary responsibility is to ensure that participants are not exposed to harm. This often means asking tough questions, challenging study designs, and advocating for participant rights. Ultimately, our goal is to enable ethical research that benefits both individuals and society.

Historically, the IRB was seen as a bureaucratic hurdle, hindering the progress of research. However, efforts have been made to increase transparency and streamline processes. Inviting principal investigators to IRB meetings, an improvement that is part of the Clinical Trial Excellence Campaign (CTEC), allows for direct communication, quicker resolution of issues, and faster approval times. While challenges remain, there is a shift towards recognizing the IRB's role in ensuring ethical research and protecting participants.

The IRB plays a crucial role in safeguarding the rights and welfare of research participants. Our decisions directly impact the safety and well-being of patients involved in clinical trials. By carefully reviewing study protocols, we ensure that risks are minimized, and potential benefits are maximized. The IRB's work not only contributes to the advancement of medical knowledge but also fosters trust between researchers and the community.

What keeps me committed to the IRB is the tangible impact we have on research outcomes and patient safety. Seeing studies progress from approval to publication, knowing that we have contributed to potentially life-saving treatments, is incredibly fulfilling. Our work ensures that the highest standards are maintained in scientific inquiry.

I also admire the dedication of everyone involved in the IRB process. From committee members to staff, we all work tirelessly to uphold ethical standards in research. Despite the challenges and complexities, we face, I am proud of the work we do and the impact it has. As research evolves, so does the role of the IRB, and I am honored to be part of this critical aspect of scientific progress.