Too Many Cooks in the Kitchen? The Legal Challenges Presented by Multijurisdictional Stem Cell Research Collaborations

Human embryonic stem cell research has attracted a lot of official attention.  Its promises and dangers have prompted responses in many forms and from all directions - federal restrictions, differing state legislation, ethical guidance from numerous organizations, citizens' groups litigation, and independent funding bodies' regulations - with each representative group claiming some form of jurisdiction over, or expertise regarding, human embryonic stem cell-related research.  With so many cooks in the kitchen, research institutions and IVF providers face a confusing array of requirements that present compliance challenges. In this teleconference, Nancy Forbes of Ropes & Gray aims to cut through the confusion. Which of the numerous, recently enacted directives apply?  Where and when? Which have the force of law? What are the conflicts and inconsistencies among these various statements of law and policy?  How should legal counsel proceed in advising their clients, whether they are research institutions, medical centers, medical schools  or biotech companies? Special attention will be paid to the uncertainties such variations  pose to interstate and international stem cell research collaborations.

Specific issues that will be considered are:

• Recognizing divergences in laws and understanding their consequences with a specific focus on:

°          The purview and scope of IRB and ESCRO reviews;

°          Informed consent requirements;

°          Compensation of egg donors;

°          Standards for oocyte procurement, and

°          Reporting requirements.

• Distinguishing legal requirements from ethical guidelines.
  
• Determining applicable law in multijurisdictional stem cell research collaborations and when transferring human embryos or human embryonic stem cell lines across state lines.