Elements of Informed Consent

Basic Elements of Informed Consent

Basic elements of informed consent must be included in the information provided to participants unless elements are waived or and alteration is approved by the IRB under specific conditions. The basic elements are:

  • Include all of the following:

    • A statement that the study involves research;

    • An explanation of the purposes of the research;

    • The expected duration of the subject’s participation;

  • A description of the procedures to be followed and identification of any procedures that are experimental;

  • A description of any reasonably foreseeable risks or discomforts to the subject;

  • A description of any benefits to the subject or to others that may reasonably be expected from the research;

  • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

  • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

  • For FDA regulated research, a statement that notes the possibility that the Food and Drug Administration may inspect the records;

  • One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:

    • A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or

    • A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

  • 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;

  • An explanation of whom to contact:

    • For answers to pertinent questions about the research (researcher's name and phone/address, and that of faculty advisor if investigator is a student);

    • Regarding research subjects' rights (Research Compliance Services); and

    • In the event of a research-related injury to the subject (Research Compliance Services).

  • 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.

  • An indication that the subject may keep a copy of the consent form.

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Additional Elements of Informed Consent

Additional elements of informed consent must be included in the information provided to participants, when applicable. The additional elements are:

  • 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) that are currently unforeseeable;

  • Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s or the legally authorized representative’s consent;

  • Any additional costs to the subject that may result from participation in the research;

  • The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;

  • 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;

  • The approximate number of subjects involved in the study;

  • A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;

  • A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and

  • For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

  • For FDA regulated research, when seeking informed consent for applicable clinical trials, the following statement needs to be included: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results.  You can search this web site at any time.”

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