Assisted reproductive technologies: advances in medical practice or human subject research?

Although human subject research is regulated by federal agencies, the differences between research and innovative clinical practice are often blurred. Research and innovative practices share the similar goals of obtaining additional knowledge and improving medical treatment. Research, however, is more specifically defined as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Aprocedure consistent with this definition is subject to distinct federal regulations and other ethical procedural safeguards. When unregulated innovative practices, not neatly fitting within this definition of research, are first implemented, safeguards do not necessarily exist because use of these procedures is primarily guided by individual physician judgment. Recognizing that the application of innovative advancements in ART may very well benefit numerous prospective infertile patients and may initially appear to be safe and effective, these new and novel procedures may be associated with yet unknown long-term risks and safety concerns unless more formal scientific study is conducted to support efficacy and safety.