October 26, 1998
The purpose of this letter is to confirm to institutional review boards (IRBs) that the Food and Drug Administration (FDA) has jurisdiction over clinical research using cloning technology to create a human being, and to inform IRBs of the FDA regulatory process that is required before any investigator can proceed with such a clinical investigation. This letter is being sent to IRBs at this time because of reports in the media that scientists are contemplating the use of cloning technology to create human beings. As described more fully below, the appropriate mechanism to pursue a clinical investigation using cloning technology is the submission of an investigational new drug application (IND) to FDA.
Clinical research using cloning technology to create a human being is subject to FDA regulation under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. Under these statutes and FDA's implementing regulations, before such research may begin, the sponsor of the research is required to submit to FDA an IND 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. Such research may proceed only when an IND is in effect. 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, FDA would not permit any such investigation to proceed.
FDA may prohibit a sponsor from conducting a study proposed in an IND application (often referred to as placing the study on "clinical hold") for a variety of reasons. If the Agency finds that "human subjects are or would be exposed to an unreasonable and significant risk of illness or injury," that would be sufficient reason to put a study on clinical hold. Other reasons listed in the regulations include "the IND does not contain sufficient information required ... to address the risks to subjects of the proposed studies," or "the clinical investigators ... are not qualified by reason of their scientific training and experience to conduct the investigation."
The procedures and requirements governing the use of investigational new drugs, including those for the submission and review of INDs, are set forth in Title 21 of the Code of Federal Regulations (CFR), Part 312. Additional responsibilities of the sponsor of an IND include: selecting qualified investigators and overseeing the conduct of the investigators; ensuring that the investigations are performed in accordance with the protocols of the IND; submitting adverse experience reports and annual reports; and other duties as outlined in the regulations. The responsibilities of an investigator include: ensuring that the study is conducted in accordance with the protocols; obtaining informed consent from study subjects; and ensuring that an IRB that complies with the requirements of 21 CFR Part 56 reviews and approves the proposed clinical study and the informed consent form and procedures for obtaining informed consent, among other requirements specified in the regulations. IRBs and clinical investigators may obtain a copy of the current "Information Sheets for IRBs and Clinical Investigators" by contacting FDA's Office of Health Affairs (301-827-1685), through the world wide web (http://www.fda.gov/oha/IRB/toc.html*) or through a Fax-on-demand system (1-800-993-0098).
We hope the above information is useful to you. Please feel free to share this information with others at your institution.
Stuart L. Nightingale, M.D.