The regulation of stem cell research in the United States is comprised of a combination of decades-old federal human subjects protections plus a set of stem cell research–specific ethical standards voluntarily adopted by institutions since 2005. In this chapter I trace over the main contours of these two components, acknowledging along the way new questions that emerge concerning the limits of these approaches to overseeing the stem cell field.

From Belmont Principles to Federal Regulation

In the United States there is a close historical connection between the philosophical ethical principles outlined in the Belmont Report and the federal regulation of human subjects research. Widespread public revelations of exploitive scientific studies using vulnerable populations, such as the Tuskegee Syphilis Study and the Willowbrook State School hepatitis study, led the U.S. Senate to pass the National Research Act of 1974. This act achieved two very important results. First, it established the requirement that anyone applying for a federal grant to support research using human subjects must have their study proposals reviewed by an independent local committee known as an Institutional Review Board (IRB), which is responsible for protecting the rights and interests of human research subjects. The second major outcome of the act was the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, a group of scholars, physicians, and lawyers assembled to identify basic ethical principles underlying all human subjects research. The National Commission issued its report in 1979, widely referred to today as the Belmont Report. In this report the authors highlighted the importance of respect for persons, beneficence, and justice – as discussed in Chapter 3. The Belmont Report recommended that each of these basic moral principles could be practically applied to the conduct of research through the institutional regulatory requirements of informed consent, risk-benefit assessment, and fair subject selection.