 The Declaration of Helsinki (World Medical Organization 1996) allows individuals who cannot consent to be enrolled in clinical research based on the permission of the participant’s representative. The U.S. federal regulations governing clinical research take a similar approach. These regulations are not laws in the strict sense of being passed by Congress and applying to all research conducted on U.S. soil. Instead, the regulations represent administrative laws which effectively attach to clinical research at the beginning and the end. Research conducted using U.S. federal monies, for instance, research funded by the NIH, or research involving NIH researchers, must follow the U.S. regulations (Department of Health and Human Services 2005). Research that is included as part of an application for approval from the U.S. FDA also must have been conducted according to FDA regulations which, except for a few exceptions, are essentially the same. Although many countries now have their own national regulations (Brody 1998), the U.S. regulations continue to exert enormous influence around the world because so much clinical research is conducted using U.S. federal money and U.S. federal investigators, and the developers of medical treatments often want to obtain approval for the U.S. market.