Laws Related to the Protection of Human Subjects

[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR50.24]

[Page 287-289]

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. 50.24 Exception from informed consent requirements for emergency research.

[(a) The IRB responsible for the review, approval, and continuing
review of the clinical investigation described in this section may
approve that investigation without requiring that informed consent of
all research subjects be obtained if the IRB (with the concurrence of a
licensed physician who is

[[[Page 288]]

[a member of or consultant to the IRB and who is not otherwise
participating in the clinical investigation) finds and documents each of
the following:
(1) The human subjects are in a life-threatening situation,
available treatments are unproven or unsatisfactory, and the collection
of valid scientific evidence, which may include evidence obtained
through randomized placebo-controlled investigations, is necessary to
determine the safety and effectiveness of particular interventions.
(2) Obtaining informed consent is not feasible because:
(i) The subjects will not be able to give their informed consent as
a result of their medical condition;
(ii) The intervention under investigation must be administered
before consent from the subjects' legally authorized representatives is
feasible; and
(iii) There is no reasonable way to identify prospectively the
individuals likely to become eligible for participation in the clinical
investigation.
(3) Participation in the research holds out the prospect of direct
benefit to the subjects because:
(i) Subjects are facing a life-threatening situation that
necessitates intervention;
(ii) Appropriate animal and other preclinical studies have been
conducted, and the information derived from those studies and related
evidence support the potential for the intervention to provide a direct
benefit to the individual subjects; and
(iii) Risks associated with the investigation are reasonable in
relation to what is known about the medical condition of the potential
class of subjects, the risks and benefits of standard therapy, if any,
and what is known about the risks and benefits of the proposed
intervention or activity.
(4) The clinical investigation could not practicably be carried out
without the waiver.
(5) The proposed investigational plan defines the length of the
potential therapeutic window based on scientific evidence, and the
investigator has committed to attempting to contact a legally authorized
representative for each subject within that window of time and, if
feasible, to asking the legally authorized representative contacted for
consent within that window rather than proceeding without consent. The
investigator will summarize efforts made to contact legally authorized
representatives and make this information available to the IRB at the
time of continuing review.
(6) The IRB has reviewed and approved informed consent procedures
and an informed consent document consistent with Sec. 50.25. These
procedures and the informed consent document are to be used with
subjects or their legally authorized representatives in situations where
use of such procedures and documents is feasible. The IRB has reviewed
and approved procedures and information to be used when providing an
opportunity for a family member to object to a subject's participation
in the clinical investigation consistent with paragraph (a)(7)(v) of
this section.
(7) Additional protections of the rights and welfare of the subjects
will be provided, including, at least:
(i) Consultation (including, where appropriate, consultation carried
out by the IRB) with representatives of the communities in which the
clinical investigation will be conducted and from which the subjects
will be drawn;
(ii) Public disclosure to the communities in which the clinical
investigation will be conducted and from which the subjects will be
drawn, prior to initiation of the clinical investigation, of plans for
the investigation and its risks and expected benefits;
(iii) Public disclosure of sufficient information following
completion of the clinical investigation to apprise the community and
researchers of the study, including the demographic characteristics of
the research population, and its results;
(iv) Establishment of an independent data monitoring committee to
exercise oversight of the clinical investigation; and
(v) If obtaining informed consent is not feasible and a legally
authorized representative is not reasonably available, the investigator
has committed, if feasible, to attempting to contact within the
therapeutic window the subject's family member who is not a legally
authorized representative, and asking whether he or she objects to the

[[[Page 289]]

[subject's participation in the clinical investigation. The investigator
will summarize efforts made to contact family members and make this
information available to the IRB at the time of continuing review.
(b) The IRB is responsible for ensuring that procedures are in place
to inform, at the earliest feasible opportunity, each subject, or if the
subject remains incapacitated, a legally authorized representative of
the subject, or if such a representative is not reasonably available, a
family member, of the subject's inclusion in the clinical investigation,
the details of the investigation and other information contained in the
informed consent document. The IRB shall also ensure that there is a
procedure to inform the subject, or if the subject remains
incapacitated, a legally authorized representative of the subject, or if
such a representative is not reasonably available, a family member, that
he or she may discontinue the subject's participation at any time
without penalty or loss of benefits to which the subject is otherwise
entitled. If a legally authorized representative or family member is
told about the clinical investigation and the subject's condition
improves, the subject is also to be informed as soon as feasible. If a
subject is entered into a clinical investigation with waived consent and
the subject dies before a legally authorized representative or family
member can be contacted, information about the clinical investigation is
to be provided to the subject's legally authorized representative or
family member, if feasible.
(c) The IRB determinations required by paragraph (a) of this section
and the documentation required by paragraph (e) of this section are to
be retained by the IRB for at least 3 years after completion of the
clinical investigation, and the records shall be accessible for
inspection and copying by FDA in accordance with Sec. 56.115(b) of this
chapter.
(d) Protocols involving an exception to the informed consent
requirement under this section must be performed under a separate
investigational new drug application ( IND) or investigational device
exemption (IDE) that clearly identifies such protocols as protocols that
may include subjects who are unable to consent. The submission of those
protocols in a separate IND/IDE is required even if an IND for the same
drug product or an IDE for the same device already exists. Applications
for investigations under this section may not be submitted as amendments
under Secs. 312.30 or 812.35 of this chapter.
(e) If an IRB determines that it cannot approve a clinical
investigation because the investigation does not meet the criteria in
the exception provided under paragraph (a) of this section or because of
other relevant ethical concerns, the IRB must document its findings and
provide these findings promptly in writing to the clinical investigator
and to the sponsor of the clinical investigation. The sponsor of the
clinical investigation must promptly disclose this information to FDA
and to the sponsor's clinical investigators who are participating or are
asked to participate in this or a substantially equivalent clinical
investigation of the sponsor, and to other IRB's that have been, or are,
asked to review this or a substantially equivalent investigation by that
sponsor.

back to top