Letter to Associations - Cloning Technology
Department of Health and Human Services Public Health
Service Food and Drug Administration 1401 Rockville
Pike Rockville, MD 20852-1448
March 28, 2001
Dear:
The purpose of this letter is to remind your organization and its
members that the Food and Drug Administration (FDA) has jurisdiction
over clinical research using cloning technology to clone a human
being, and to inform you of the FDA regulatory process that is
required. You are receiving this letter because of a number of
recent reports in the media describing the use of cloning technology
to clone human beings. As described more fully below, the
appropriate mechanism to pursue such clinical investigation using
cloning technology is the submission of an investigational new drug
application (IND) to FDA's Center for Biologics Evaluation and
Research (CBER). Please inform the members of your organization of
the information provided below.
Clinical research using cloning technology to clone 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; obtain authorization from a
properly constituted institutional review board (IRB); and 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 the FDA believes that there are
major unresolved safety questions pertaining to the use of cloning
technology to clone a human being, until those questions are
appropriately addressed in an 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
assess 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
participants; 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.
Clinical investigators are encouraged to obtain a copy of the
current "Information Sheets for IRBs and Clinical Investigators"
(which contains useful information regarding clinical
investigations) from CBER's Manufacturers Assistance and Technical
Training Branch at 1-800-835-4709. This document is also available
at: http://www.fda.gov/oc/ohrt/irbs/.
Additional information on how to submit an IND can be found on
CBER's website at: http://www.fda.gov/cber/ind/ind.htm.
Copies of the relevant sections of 21 CFR, including Parts 50
(Protection of Human Subjects), 56 (Institutional Review Boards),
and 312 (Investigational New Drug Application) can be found at:
http://www.gpo.gov/nara/cfr. Information on ways to communicate with
CBER is available for you or members of the association at: http://www.fda.gov/cber/pubinquire.htm.
We encourage your members to meet with the Agency prior to
submitting any IND application. Such a meeting would be arranged
through the Office of Therapeutics Research and Review of FDA's
Center for Biologics Evaluation and Research.
Sincerely yours,
--- signature ---
Kathryn C. Zoon, Ph.D. Director Center for Biologics
Evaluation And Research
Note: the link for the "Information Sheets for
IRBs and Clinical Investigators" has been changed to http://www.fda.gov/oc/ohrt/irbs/.
Last Updated:
12/27/2002
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