[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR50.23]
[Page 282-285]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 50 PROTECTION OF HUMAN SUBJECTS--Table of Contents
Subpart B Informed Consent of Human Subjects
Sec. 50.23 Exception from general requirements.
(a) The obtaining of informed consent shall be deemed feasible
unless, before use of the test article (except as provided in paragraph
(b) of this section), both the investigator and a physician who is not
otherwise participating in the clinical investigation certify in writing
all of the following:
(1) The human subject is confronted by a life-threatening situation
necessitating the use of the test article.
(2) Informed consent cannot be obtained from the subject because of
an inability to communicate with, or obtain legally effective consent
from, the subject.
(3) Time is not sufficient to obtain consent from the subject's
legal representative.
(4) There is available no alternative method of approved or
generally recognized therapy that provides an equal or greater
likelihood of saving the life of the subject.
(b) If immediate use of the test article is, in the investigator's
opinion, required to preserve the life of the subject, and time is not
sufficient to obtain the independent determination required in paragraph
(a) of this section in advance of using the test article, the
determinations of the clinical investigator shall be made and, within 5
working days after the use of the article, be reviewed and evaluated in
writing by a physician who is not participating in the clinical
investigation.
(c) The documentation required in paragraph (a) or (b) of this
section shall be submitted to the IRB within 5 working days after the
use of the test article.
(d)(1) Under 10 U.S.C. 1107(f) the President may waive the prior
consent requirement for the administration of an investigational new
drug to a member of the armed forces in connection with the member's
participation in a particular military operation. The statute specifies
that only the President may waive informed consent in this connection
and the President may grant such a waiver only if the President
determines in writing that obtaining consent: Is not feasible; is
contrary to the best interests of the military member; or is not in the
interests of national security. The statute further provides that in
making a determination to waive prior informed consent on the ground
that it is not feasible or the ground that it is contrary to the best
interests of the military members involved, the President shall apply
the standards and criteria that are set forth in the relevant FDA
regulations for a waiver of the prior informed consent requirements of
section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(i)(4)). Before such a
[[Page 283]]
determination may be made that obtaining informed consent from military
personnel prior to the use of an investigational drug (including an
antibiotic or biological product) in a specific protocol under an
investigational new drug application (IND) sponsored by the Department
of Defense (DOD) and limited to specific military personnel involved in
a particular military operation is not feasible or is contrary to the
best interests of the military members involved the Secretary of Defense
must first request such a determination from the President, and certify
and document to the President that the following standards and criteria
contained in paragraphs (d)(1) through (d)(4) of this section have been
met.
(i) The extent and strength of evidence of the safety and
effectiveness of the investigational new drug in relation to the medical
risk that could be encountered during the military operation supports
the drug's administration under an IND.
(ii) The military operation presents a substantial risk that
military personnel may be subject to a chemical, biological, nuclear, or
other exposure likely to produce death or serious or life-threatening
injury or illness.
(iii) There is no available satisfactory alternative therapeutic or
preventive treatment in relation to the intended use of the
investigational new drug.
(iv) Conditioning use of the investigational new drug on the
voluntary participation of each member could significantly risk the
safety and health of any individual member who would decline its use,
the safety of other military personnel, and the accomplishment of the
military mission.
(v) A duly constituted institutional review board (IRB) established
and operated in accordance with the requirements of paragraphs (d)(2)
and (d)(3) of this section, responsible for review of the study, has
reviewed and approved the investigational new drug protocol and the
administration of the investigational new drug without informed consent.
DOD's request is to include the documentation required by Sec.
56.115(a)(2) of this chapter.
(vi) DOD has explained:
(A) The context in which the investigational drug will be
administered, e.g., the setting or whether it will be self-administered
or it will be administered by a health professional;
(B) The nature of the disease or condition for which the preventive
or therapeutic treatment is intended; and
(C) To the extent there are existing data or information available,
information on conditions that could alter the effects of the
investigational drug.
(vii) DOD's recordkeeping system is capable of tracking and will be
used to track the proposed treatment from supplier to the individual
recipient.
(viii) Each member involved in the military operation will be given,
prior to the administration of the investigational new drug, a specific
written information sheet (including information required by 10 U.S.C.
1107(d)) concerning the investigational new drug, the risks and benefits
of its use, potential side effects, and other pertinent information
about the appropriate use of the product.
(ix) Medical records of members involved in the military operation
will accurately document the receipt by members of the notification
required by paragraph (d)(1)(viii) of this section.
(x) Medical records of members involved in the military operation
will accurately document the receipt by members of any investigational
new drugs in accordance with FDA regulations including part 312 of this
chapter.
(xi) DOD will provide adequate followup to assess whether there are
beneficial or adverse health consequences that result from the use of
the investigational product.
(xii) DOD is pursuing drug development, including a time line, and
marketing approval with due diligence.
(xiii) FDA has concluded that the investigational new drug protocol
may proceed subject to a decision by the President on the informed
consent waiver request.
(xiv) DOD will provide training to the appropriate medical personnel
and potential recipients on the specific investigational new drug to be
administered prior to its use.
(xv) DOD has stated and justified the time period for which the
waiver is needed, not to exceed one year, unless
[[Page 284]]
separately renewed under these standards and criteria.
(xvi) DOD shall have a continuing obligation to report to the FDA
and to the President any changed circumstances relating to these
standards and criteria (including the time period referred to in
paragraph (d)(1)(xv) of this section) or that otherwise might affect the
determination to use an investigational new drug without informed
consent.
(xvii) DOD is to provide public notice as soon as practicable and
consistent with classification requirements through notice in the
Federal Register describing each waiver of informed consent
determination, a summary of the most updated scientific information on
the products used, and other pertinent information.
(xviii) Use of the investigational drug without informed consent
otherwise conforms with applicable law.
(2) The duly constituted institutional review board, described in
paragraph (d)(1)(v) of this section, must include at least 3
nonaffiliated members who shall not be employees or officers of the
Federal Government (other than for purposes of membership on the IRB)
and shall be required to obtain any necessary security clearances. This
IRB shall review the proposed IND protocol at a convened meeting at
which a majority of the members are present including at least one
member whose primary concerns are in nonscientific areas and, if
feasible, including a majority of the nonaffiliated members. The
information required by Sec. 56.115(a)(2) of this chapter is to be
provided to the Secretary of Defense for further review.
(3) The duly constituted institutional review board, described in
paragraph (d)(1)(v) of this section, must review and approve:
(i) The required information sheet;
(ii) The adequacy of the plan to disseminate information, including
distribution of the information sheet to potential recipients, on the
investigational product (e.g., in forms other than written);
(iii) The adequacy of the information and plans for its
dissemination to health care providers, including potential side
effects, contraindications, potential interactions, and other pertinent
considerations; and
(iv) An informed consent form as required by part 50 of this
chapter, in those circumstances in which DOD determines that informed
consent may be obtained from some or all personnel involved.
(4) DOD is to submit to FDA summaries of institutional review board
meetings at which the proposed protocol has been reviewed.
(5) Nothing in these criteria or standards is intended to preempt or
limit FDA's and DOD's authority or obligations under applicable statutes
and regulations.
(e)(1) Obtaining informed consent for investigational in vitro
diagnostic devices used to identify chemical, biological, radiological,
or nuclear agents will be deemed feasible unless, before use of the test
article, both the investigator (e.g., clinical laboratory director or
other responsible individual) and a physician who is not otherwise
participating in the clinical investigation make the determinations and
later certify in writing all of the following:
(i) The human subject is confronted by a life-threatening situation
necessitating the use of the investigational in vitro diagnostic device
to identify a chemical, biological, radiological, or nuclear agent that
would suggest a terrorism event or other public health emergency.
(ii) Informed consent cannot be obtained from the subject because:
(A) There was no reasonable way for the person directing that the
specimen be collected to know, at the time the specimen was collected,
that there would be a need to use the investigational in vitro
diagnostic device on that subject's specimen; and
(B) Time is not sufficient to obtain consent from the subject
without risking the life of the subject.
(iii) Time is not sufficient to obtain consent from the subject's
legally authorized representative.
(iv) There is no cleared or approved available alternative method of
diagnosis, to identify the chemical, biological, radiological, or
nuclear agent that provides an equal or greater likelihood of saving the
life of the subject.
[[Page 285]]
(2) If use of the investigational device is, in the opinion of the
investigator (e.g., clinical laboratory director or other responsible
person), required to preserve the life of the subject, and time is not
sufficient to obtain the independent determination required in paragraph
(e)(1) of this section in advance of using the investigational device,
the determinations of the investigator shall be made and, within 5
working days after the use of the device, be reviewed and evaluated in
writing by a physician who is not participating in the clinical
investigation.
(3) The investigator must submit the documentation required in
paragraph (e)(1) or (e)(2) of this section to the IRB within 5 working
days after the use of the device.
(4) An investigator must disclose the investigational status of the
in vitro diagnostic device and what is known about the performance
characteristics of the device in the report to the subject's health care
provider and in any report to public health authorities. The
investigator must provide the IRB with the information required in Sec.
50.25 (except for the information described in Sec. 50.25(a)(8)) and
the procedures that will be used to provide this information to each
subject or the subject's legally authorized representative at the time
the test results are provided to the subject's health care provider and
public health authorities.
(5) The IRB is responsible for ensuring the adequacy of the
information required in section 50.25 (except for the information
described in Sec. 50.25(a)(8)) and for ensuring that procedures are in
place to provide this information to each subject or the subject's
legally authorized representative.
(6) No State or political subdivision of a State may establish or
continue in effect any law, rule, regulation or other requirement that
informed consent be obtained before an investigational in vitro
diagnostic device may be used to identify chemical, biological,
radiological, or nuclear agent in suspected terrorism events and other
potential public health emergencies that is different from, or in
addition to, the requirements of this regulation.
[46 FR 8951, Jan. 27, 1981, as amended at 55 FR 52817, Dec. 21, 1990; 64
FR 399, Jan. 5, 1999; 64 FR 54188, Oct. 5, 1999; 71 FR 32833, June 7,
2006]
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