[Code of Federal Regulations]

[Title 49, Volume 1]

[Revised as of October 1, 2005]

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

[CITE: 49CFR11.116]



[Page 106-108]

 

                        TITLE 49--TRANSPORTATION

 

          Subtitle A--Office of the Secretary of Transportation

 

PART 11_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

Sec. 11.116  General requirements for informed consent.



    Except as provided elsewhere in this policy, no investigator may 

involve a human being as a subject in research



[[Page 107]]



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;

    (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



[[Page 108]]



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]