controverted issues

An issue discussed at an IRB meeting for which there is a disagreement between some IRB members, or there are opposing viewpoints among IRB members that are voiced during the IRB deliberations. Federal regulations require a summary of controverted issues and their resolution to be included in IRB meeting minutes.

This definition was provided through email correspondence between the 91̽»¨Institutional Official and the OHRP Director of the Division of Compliance Oversight (June 6, 2008).