The accelerating pace of development of new drugs and medical devices has created exciting new opportunities for health care providers, entrepreneurs, pharmaceutical companies and others. Along with these new opportunities come new challenges, as the law struggles to keep pace with science. In conjunction with the firm’s intellectual property practice and others, members of the health law department work with physicians, institutions, site management companies, research organizations, medical staffs and others to identify and resolve legal issues arising from the rising tide of medical research and biotechnology.

Representative projects include:

• Negotiating and drafting clinical trial agreements with sponsors, institutions, CROs and principal investigators;
  
• Representing physicians involved in post-graduate training programs and related research projects;
  
• Advising clients regarding compliance with institutional review boards (IRBs), the Food and Drug Administration (FDA) and the Office for Human Resource Protections (OHRP)requirements, including requirements relating to participant informed consent; adverse events; and conflicts of interest;
  
• Representing principal investigators in negotiations with sponsors and institutions;
  
• Advising medical staffs regarding the establishment of privileging criteria for new technology and new applications of existing technology;
  
• Assisting clients in the development of policies and procedures designed to minimize fraud and abuse liability in connection with billing practices in clinical trials;
  
• Representing providers accused of unprofessional conduct in connection with experimental treatment;
  
• Structuring research joint ventures between physicians and other health care providers; and
  
• Educating and advising clients regarding HIPAA compliance in the research setting.