Barbara Handelin and Susan Katz 
Public Responsibility in Medicine and Research (PRIM&R), Boston, Massachusetts 
bhandelin@compuserve.com 

IRBs are under extreme stress to provide adequate review of all manner of protocols. A central assumption that underlies the IRB's charge to protect the rights and welfare of human subjects involved in research, is that each individual IRB will possess or develop the requisite expertise to accomplish this mission adequately. The increasingly complex ethical, regulatory and scientific issues presented to IRBs in reviewing genetic research protocols challenge the validity of this assumption. Individual IRBs have inadequate time and resources to develop the necessary genetics expertise and facility to deal with this new challenge. Thus, our project has been developed to solicit specific needs from IRBs so that specific working "tools" can be created to address those needs. We will report on our progress toward that end. But that is not all....as we are also addressing the concomitant increased pressure on biotech and genomics companies to conform to a standard of practice in conducting research studies and in developing marketing plans for gene based products and services. As such companies become engaged in clinical studies involving human subjects or tissues it has become apparent that they may need help in effecting quality, IRB-like review. In this project we are seeking to exploit the synergistic needs and expertise found in these two types of organizations: the ethics oversight capabilities and systems of IRBs and the genome expertise in industrial R&D shops. We will report on the dynamic interplay and relative perspectives that IRBs and the biotech communities have of one another and how we are proposing to weave common solutions to critical issues in the safe and ethical participation of human subjects in genetic research.