[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2005]

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

[CITE: 45CFR46.116]



[Page 123-124]

 

                        TITLE 45--PUBLIC WELFARE

 

           SUBTITLE A--DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

PART 46_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

  Subpart A_Basic HHS Policy for Protection of Human Research Subjects

 

Sec. 46.116  General requirements for informed consent.



    Except as provided elsewhere in this policy, no investigator may 

involve a human being as a subject in research covered by this policy 

unless the investigator has obtained the legally effective informed 

consent of the subject or the subject's legally authorized 

representative. An investigator shall seek such consent only under 

circumstances that provide the prospective subject or the representative 

sufficient opportunity to consider whether or not to participate and 

that minimize the possibility of coercion or undue influence. The 

information that is given to the subject or the representative shall be 

in language understandable to the subject or the representative. No 

informed consent, whether oral or written, may include any exculpatory 

language through which the subject or the representative is made to 

waive or appear to waive any of the subject's legal rights, or releases 

or appears to release the investigator, the sponsor, the institution or 

its agents from liability for negligence.

    (a) Basic elements of informed consent. Except as provided in 

paragraph (c) or (d) of this section, in seeking informed consent the 

following information shall be provided to each subject:

    (1) A statement that the study involves research, an explanation of 

the purposes of the research and the expected duration of the subject's 

participation, a description of the procedures to be followed, and 

identification of any procedures which are experimental;

    (2) A description of any reasonably foreseeable risks or discomforts 

to the subject;

    (3) A description of any benefits to the subject or to others which 

may reasonably be expected from the research;

    (4) A disclosure of appropriate alternative procedures or courses of 

treatment, if any, that might be advantageous to the subject;



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    (5) A statement describing the extent, if any, to which 

confidentiality of records identifying the subject will be maintained;

    (6) For research involving more than minimal risk, an explanation as 

to whether any compensation and an explanation as to whether any medical 

treatments are available if injury occurs and, if so, what they consist 

of, or where further information may be obtained;

    (7) An explanation of whom to contact for answers to pertinent 

questions about the research and research subjects' rights, and whom to 

contact in the event of a research-related injury to the subject; and

    (8) A statement that participation is voluntary, refusal to 

participate will involve no penalty or loss of benefits to which the 

subject is otherwise entitled, and the subject may discontinue 

participation at any time without penalty or loss of benefits to which 

the subject is otherwise entitled.

    (b) Additional elements of informed consent. When appropriate, one 

or more of the following elements of information shall also be provided 

to each subject:

    (1) A statement that the particular treatment or procedure may 

involve risks to the subject (or to the embryo or fetus, if the subject 

is or may become pregnant) which are currently unforeseeable;

    (2) Anticipated circumstances under which the subject's 

participation may be terminated by the investigator without regard to 

the subject's consent;

    (3) Any additional costs to the subject that may result from 

participation in the research;

    (4) The consequences of a subject's decision to withdraw from the 

research and procedures for orderly termination of participation by the 

subject;

    (5) A statement that significant new findings developed during the 

course of the research which may relate to the subject's willingness to 

continue participation will be provided to the subject; and

    (6) The approximate number of subjects involved in the study.

    (c) An IRB may approve a consent procedure which does not include, 

or which alters, some or all of the elements of informed consent set 

forth above, or waive the requirement to obtain informed consent 

provided the IRB finds and documents that:

    (1) The research or demonstration project is to be conducted by or 

subject to the approval of state or local government officials and is 

designed to study, evaluate, or otherwise examine: (i) Public benefit of 

service programs; (ii) procedures for obtaining benefits or services 

under those programs; (iii) possible changes in or alternatives to those 

programs or procedures; or (iv) possible changes in methods or levels of 

payment for benefits or services under those programs; and

    (2) The research could not practicably be carried out without the 

waiver or alteration.

    (d) An IRB may approve a consent procedure which does not include, 

or which alters, some or all of the elements of informed consent set 

forth in this section, or waive the requirements to obtain informed 

consent provided the IRB finds and documents that:

    (1) The research involves no more than minimal risk to the subjects;

    (2) The waiver or alteration will not adversely affect the rights 

and welfare of the subjects;

    (3) The research could not practicably be carried out without the 

waiver or alteration; and

    (4) Whenever appropriate, the subjects will be provided with 

additional pertinent information after participation.

    (e) The informed consent requirements in this policy are not 

intended to preempt any applicable federal, state, or local laws which 

require additional information to be disclosed in order for informed 

consent to be legally effective.

    (f) Nothing in this policy is intended to limit the authority of a 

physician to provide emergency medical care, to the extent the physician 

is permitted to do so under applicable federal, state, or local law.



(Approved by the Office of Management and Budget under Control Number 

0990-0260)



[56 FR 28012, 28022, June 18, 1991, as amended at 70 FR 36328, June 23, 

2005]



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