Abstract

The risks to groups posed by research involving human beings—including genetics research—should be conceived of as a species of third-party risks. The important task of protecting third parties from the risks posed by the conduct and the findings of research should not be assigned to IRBs because they are not designed or equipped to handle such a broad responsibility. The serious problems raised by third-party risks require an integration of policy-making and regulation that is beyond the scope and competence of IRBs