Regulations as a Floor or a Ceiling: Group Interaction

About this session

Examining extra-regulatory policies and their value. This session would explore the potential value extra-regulatory policies and practices and the value vs. the burden that these present for the research community and the institution. As an example, many IRBs prior to 2007 guidance from OHRP required all adverse events to be submitted for review; many have changed their practices to only unanticipated problems (as per regulations) but many have also maintained reporting requirements beyond what the regulations require. This session would explore, via group discussion, the potential value of these policies and/or practices and propose a valuing system by which an institution may analyze existing policies for their impact.

Speaker

• JF

  Joshua Fedewa

  Director of Research Consulting · Advarra

  Facilitator