Health Care Group Teleconference: Research Update: Summer 2005

June 28, 2005

Mark Barnes and Eve Brunts, partners in the Health Care Group at Ropes & Gray, will discuss the latest developments in research compliance, including:

  • the "crush" on IRBs of adverse events reporting and procedural alternatives for IRBs and research programs
  • recent developments in Medicare billing policy for services rendered in the course of clinical trials
  • federal grants "time and effort" enforcement activity
  • National Academies/Institute of Medicine report on stem cell research and implications for IVF programs
  • registration of clinical trials required by leading medical journals, and the need for registration of investigator-initiated studies
  • HIPAA and research guidance issued by NIH in May 2005