Maternal-fetal research and human research protections policy.

It may be that the current system of formal definitions, ethical theories, and voluntary professional guidelines to protect patients from unwittingly becoming subjects of research is inadequate to meet the challenge of surgical innovation. Important questions, such as when surgical innovation becomes research involving human subjects or how to distinguish between variations on an existing technique and true innovations, are key. These questions also apply to MFS as an innovative surgical therapy. Now that MFS has been recognized as experimental and formal clinical trials will be conducted, it is important to ensure adequate protection of the pregnant women and fetuses involved as human research subjects. This issue is even more pertinent in light of the new regulations regarding fetuses as research subjects. Those responsible for reviewing study protocols will have to be especially careful when examining the new version of DHHS regulations as they apply to future studies in the field of MFS.