Required Contents of Written Consent Specified in DHHS Regulations

  1. Basic elements of informed 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 that 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 that 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 and that notes the possibility that the FDA may inspect the records

    6. For research involving more-than-minimal risk, an explanation as to whether any compensation and any medical treatments are available if injury occurs and, if so, of what they consist or where further information may be obtained

    7. An explanation of whom to contact for answers to pertinent questions about the research and the rights of the research subjects 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 involves 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

  2. Additional elements of informed consent: when appropriate, 1 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 the embryo or fetus, if the subject is pregnant or may become pregnant) that 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 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 that may relate to the subject's willingness to continue participation will be provided to the subject

    6. The approximate number of subjects involved in the study