[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR50.24]



[Page 284-285]

 

                        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.  50.24  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 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;



[[Page 285]]



    (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 

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 Sec. Sec.  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]