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FDA Jurisdiction over clinical
research using cloning technology to clone a human being
To
all ASRM Members:
The
purpose of this notice is to remind the ASRM 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 and 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 preformed 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/oha/irb/toc.html.
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,
Kathryn
C. Zoon, Ph.D.
Director
Center for Biologics Evaluation and
Research
Department of Health & Human Services
Food
and Drug Administration
Copyright 2000-2003 ASRM, All
Rights Reserved
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