How Phase I Trial Ethics Are Changing For Sponsors

Phase I was once about safety and dose selection, with direct benefit a rare outcome. That is shifting, and the change complicates informed consent, risk-benefit review, and decisions about continued access to investigational products.

Two IRB leaders from BRANY, Raffaella Hart (Senior Vice President) and Linda Reuter (Sr. IRB Director), examine how therapeutic misconception differs from reasonable optimism, why consent language must be revised as a study evolves, and what happens when animal models predict human response poorly. They also consider gene therapies with long-term follow-up needs and pediatric protocols that begin with limited safety data. The authors point to what sponsors can build into design before enrollment starts.

Read the article to see how IRBs are adjusting their approach.