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    CInstitutional Review Board (IRB)
    Elements Of Consent

    THE REGULATIONS

    The general requirements for informed consent are federally mandated and appear at 45 CFR 46.116 and 21 CFR 50.116. Although every consent document must include the mandated information, an IRB may require additional information if it determines that potential subjects need it to make and informed decision about whether or not to take part or to protect subjects’ rights & welfare. The mandated elements of informed consent are as follows:

    THE EIGHT REQUIRED Elements Of Consent

    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. (If an FDA regulated product is used, the statement should also note that the FDA may inspect the records.)

    6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatment 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 subject’s rights and whom to contact in the event of a research-related injury to the subject.

    8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.


    THE ADDITIONAL OPTIONAL ELEMENTS OF CONSENT

    When appropriate, one or more 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. LThe 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 subjects’ willingness to continue participation will be provided to the subject.

    6. approximate number of subjects involved in the study.


    CALIFORNIA’S ADDITIONAL REQUIRED ELEMENTS

    1. If a placebo is to be administered or dispensed to a portion of the subjects involved in a medical experiment, all subjects of such experiment shall be informed of that fact.

    2. An estimate of the expected recovery time of the subject after the experiment.

    3. The name, institutional affiliation, if any, and address of the person or persons actually performing and primarily responsible for the conduct of the experiment.

    4. The name of the sponsor or funding source, if any, or manufacturer if the experiment involves a drug or device, and the organization, if any, under whose general aegis the experiment is being conducted.

    5. The name, address, and phone number of an impartial third party, not associated with the experiment, to whom the subject may address complaints about the experiment.

    6. Subjects must sign and be given a copy of the Experimental Subject’s Bill of Rights.



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