Copernicus Group IRB’s Veit, Higgins speak at PRIM&R conference
Two members of the Copernicus Group IRB team spoke at the 2011 Advancing Ethical Research Conference in National Harbor, Md., on Dec. 4.
CGIRB Chairperson Glenn Veit, JD, CIP, spoke on “Sponsor Responsibilities in Unanticipated Problems and Adverse Event Reporting.” His presentation reviewed new FDA regulations on adverse event reporting in Investigational New Drug (IND) trials, which went into effect in March.
CGIRB Quality Management Director Yvonne Higgins, CIP, spoke on IRB operations and management, as well as research team oversight and education. She also participated in an open discussion with other HRPP and IRB experts, and served as co-chairperson for the conference’s workshop and didactic subcommittee.
The conference was presented by Public Responsibility in Medicine and Research (PRIM&R), an organization dedicated to advancing the highest ethical standards in the conduct of research.