[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

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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.

[61 FR 51528, Oct. 2, 1996]