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Merck Manual

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Elements of Informed Consent Documents

Elements of Informed Consent Documents

  • Major Elements

    • A statement explaining the trial’s purpose, the procedures to be followed, the duration of participation, and any investigational treatments or procedures

    • A description of foreseeable risks and discomforts to participants

    • A description of benefits that the participant can reasonably expect

    • A disclosure of any alternative treatments or procedures that might be advantageous to participants

    • A statement about how participant confidentiality is maintained

    • An explanation of compensation and whether medical treatments are available if injury occurs

    • A list of contacts to answer trial-related questions and to help with research-related injuries

    • A statement that participation is voluntary and that there is no penalty and no loss of benefits for refusing to participate

  • Other Elements When Appropriate

    • A statement that there may be unforeseeable risks to the participant, embryo, or fetus—if the participant is or may become pregnant

    • A list of circumstances under which the investigator may terminate a participant’s enrollment

    • A description of additional costs to the participant

    • An explanation of the consequences and procedures if a participant decides to withdraw

    • A statement that participants will be informed of significant new findings that might affect their willingness to participate

    • The approximate number of participants enrolled in the trial

Adapted from The Food and Drug Administration, Code of Federal Regulations, Title 21, Section 50.25 (www.fda.gov).