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
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