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From the Food and Drug Administration
December 2, 1998

Jurisdiction Over Cloning Technology to Create Human Beings

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JAMA. 1998;280(21):1817. doi:10.1001/jama.280.21.1817-JFD80011-4-1

The FDA has issued a letter for IRBs confirming that the agency has jurisdiction over clinical research using cloning technology to create a human being and informing IRBs about the FDA regulatory process that is required before any investigator can proceed with such a clinical investigation. The letter was issued because of reports in the media that scientists are contemplating this research.

Before any research using cloning technology to create a human being could begin, the sponsor of the research is required to submit to FDA an Investigational New Drug (IND) application describing the proposed research plan; to obtain authorization from a properly constituted and functioning IRB; and to obtain a commitment from the investigators to obtain informed consent from all human subjects of the research. Since FDA believes that there are major unresolved safety questions pertaining to the use of cloning technology to create a human being, until those questions are appropriately addressed in the IND, the FDA would not permit any such investigation to proceed. Further information is available in the October 26, 1998, letter, which is available on the Internet at http://www.fda.gov/oc/oha/irbletr.html.

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