ABSTRACT

Federal law governing research using cells and tissues from embryos predates the human embryonic stem cell controversy, and is embedded in policies governing research with human beings, as well as the national debate surrounding abortion. The core regulations governing research on human beings are codified in the Federal Policy for the Protection of Human Subjects, also known as the Common Rule, because these regulations have been adopted by most federal agencies that sponsor human research. The Common Rule comprises subpart A of the Health and Human Services regulations, and requires the establishment of Institutional Review Boards (IRBs) to approve all federally funded human subject research. The Common Rule explicitly outlines the membership of IRBs as well as the criteria for the approval of research. The potential to be born is present in any embryo left uninterrupted in a woman's womb. But the same potential exists long before fertilization, in any sperm or egg.