PI Role and Conflict of Interest

Stacey Berg, MD, Texas Children’s Cancer Center, Houston, Texas


Fellow summary authored by Rafi Winograd, MD, PhD

Dr. Berg of Texas Children’s Hospital gave a comprehensive review of the important considerations regarding conflicts of interest (COI) and how to manage these in the career of a translational oncologist. During clinical training and in the early years of a career, most investigators do not have any formal training on the nature of COIs or how to manage them, making this overview particularly salient for the STOFF invitees.

Dr. Berg contextualized COI within the roles and responsibilities of a translational investigator, highlighting how each of these components can be subject to biases that need to be kept in mind: designing the study, writing the protocol, achieving IRB approval, and obtaining informed consent. The role of the IRB to review protocols for any biases in patient selection and to ensure that risks to subjects are minimized was discussed; notably, Dr. Berg commented that “good science addresses most IRB concerns,” which I found to be an insightful observation on the importance of grounding our clinical research using the best available data.

Focusing on financial COI, Dr. Berg made sure to highlight that there is no inherent evil to having COI, and that in fact, these are in many cases bound to happen in the career of a successful translational investigator in oncology, due to the nature of our various interactions with the Pharmaceutical and Biotech companies that produce the agents we are evaluating in clinical trials. The various strategies utilized to manage financial COI were reviewed, with emphasis on the importance of disclosing these COI on manuscripts and presentations.

Overall, Dr. Berg’s presentation was a unique review of the multiple COI that are common in the career of a translational oncologist. As early career investigators, most attendees do not yet have personal experience with COI and how to manage these to best protect the research subjects, investigator, and institution. This overview of the various types of COI and the structures in place to help clinical investigators manage these was incredibly helpful to the STOFF attendees as we embark on our independent careers.