IRB Review Of Phase I Research: Balancing Ethics And Efficiency

By Luke Gelinas, PhD, IRB Chairperson

Phase I research is a crucial part of drug and therapy development. Because it differs in important ways from later phase research, Phase I studies raise unique challenges, in both their design and implementation as well as for the institutional review board (IRB). Proactive strategies for identifying and addressing these challenges can enable ethical IRB review and timely study implementation.