In Arizona, advancing translational research requires "collaboration" across the broad base of universities, non-profit research institutions, hospitals and medical centers. The concept of the retreat is that through education and dialogue Arizona's institutions involved in clinical and translational research can develop a common understanding, language and, hopefully, approaches for addressing key policy issues in clinical and translational research. The outcomes of the retreat is more than just workshop presentations and dialogue, but follow on efforts to create policy guidelines, template forms and training materials.

Activities to Date:

• "Tissue Issue: Ethical and Legal Issues in Biorepository Research" retreat was held on January 30, 2007. Biorepositories are a growing area of activity in biomedical research. However, many hospitals, physician practices, and research sites were uncertain of the legal and ethical issues involved in providing biospecimens to third party research repositories or in storing biospecimens in their own repositories. The Retreat involved national speakers from the National Cancer Institute (Dr. Anna Barker was the keynote speaker), Faster Cures, Cleveland Clinic, University of Michigan, Partners Healthcare, and others. The Retreat was a huge success with 129 Arizona participants. Subsequent survey of participants revealed very positive response to the retreat.
  • Click Here to View the 2007 Retreat Agenda
  • "General Guidelines for Non-Profit Institutional Human Specimen Data Transfer Policies," Dr. Manoja Lecamwasam
  • "Human Specimen Procurement Service (HSPS)," Shaperio
  • "Informed Choice for Tissue Research," Dr. Edward Goldman
  • "IRB Review of Biorepository Research," Dr. Pearl O'Rourke
  • "National Efforts to Encourage Biobanking," Greg Simon
  • "The Power of Biorepositories for Research," Dr. Anna Barker
  • "The Tissue Issue: Ethical and Legal Issues in Biorepository Research"
  • "What You Need To Know When You Negotiate MTAs and CTAs," Dr. Gerald Schaefer
  
  Click Here to View the Role of the Flinn Foundation and the ABRC
  
  Click Here to View Details of the House Bill Supporting the Development of Biorepositories Through ABRC

Ongoing Activities:

• Two policy development workgroups to advance policy guidelines and timetables on "Tissue Issue: Ethical and Legal Issues in Biorepository Research". First, an IRB Policy Workgroup is working to develop template policies and procedures, informed consent documents and HIPAA authorization forms to harmonize Arizona IRB approaches to biospecimen research. Second, a Business Work Group is developing template clinical trial agreement provisions, material transfer agreements, and policies on the business aspects of biorepository research. We expect that these template documents will be widely used across the state. Many of the major research institutions in Arizona are participating in these work groups to date, each with 12 members.
  
  To learn more about these work group activities, please contact: Pam Mitchell



• Planning is now underway for the second technical policy retreat to be held in early 2008 with patient registries as the focus.
  
  To learn more about this new retreat, please contact: Mitch Horowitz