The coordinator does that.

And yet, in my experience, remarkably few coordinators have been given a precise answer to a deceptively simple question: What, exactly, am I authorized to do during the consent process -- and where does my authority end?

The answer matters more than most practitioners realize. Not because the boundaries are arbitrary, but because they exist to protect two people simultaneously: the participant, who deserves clinical judgment from someone qualified to provide it, and the coordinator, who deserves clarity about where professional responsibility begins and ends. A coordinator who unknowingly exceeds the scope of delegation is not merely committing a procedural error -- they are assuming liability for decisions they were never qualified or authorized to make.

This lesson draws the map. We will examine what ICH E6(R3) Section 2.8.5 actually authorizes, identify the tasks that may and may not be delegated to coordinators, explore the documentation requirements for consent delegation, and -- perhaps most important -- build a practical framework for navigating the blurry moments that arise in real consent conversations when a participant asks something that sits right on the boundary.

The coordinator does that.

And yet, in my experience, remarkably few coordinators have been given a precise answer to a deceptively simple question: What, exactly, am I authorized to do during the consent process -- and where does my authority end?

The answer matters more than most practitioners realize. Not because the boundaries are arbitrary, but because they exist to protect two people simultaneously: the participant, who deserves clinical judgment from someone qualified to provide it, and the coordinator, who deserves clarity about where professional responsibility begins and ends. A coordinator who unknowingly exceeds the scope of delegation is not merely committing a procedural error -- they are assuming liability for decisions they were never qualified or authorized to make.

This lesson draws the map. We will examine what ICH E6(R3) Section 2.8.5 actually authorizes, identify the tasks that may and may not be delegated to coordinators, explore the documentation requirements for consent delegation, and -- perhaps most important -- build a practical framework for navigating the blurry moments that arise in real consent conversations when a participant asks something that sits right on the boundary.