Section XI:

Informed Consent Process and Documentation

WPP #: XI-2

Title 2:

Informed Consent Documentation, Waiver of Documentation, and Required Signatures

Effective Date:

03-28-16

Revision History:

06-20-00; 09-20-01; 06-07-04; 06-21-06; 01-30-08; 1-30-08

Policy Statement

The VCU IRB may approve a consent procedure that waives the requirement to document informed consent. Unless a waiver of documentation of consent is granted, a documented informed consent process is required in accordance with 45 CFR 46.117. For information regarding the required elements of the informed consent form see IRB WPP XI-1 Informed Consent Process, Waiver, and Modification of Consent.

Description and Procedures

  1. Documentation of Informed Consent:

    A written document should be developed including all required (and applicable additional) elements of informed consent. This document is provided to the research participant. This written document may be either a (1) full written consent document or a (2) “short form” document and summary of an oral presentation of the informed consent process. At VCU, the short form process is not encouraged and would need to be justified.

    [NOTE: It is highly recommended that the VCU Office of Research Subjects Protections be consulted prior to the submission of a short form document.]

    NOTE: For all VCU consent documents (including FDA regulated research), the participant or representative must date the consent document in addition to signing it (in accordance with FDA regulations).

    45 CFR 46.117(b)
    (b) Except as provided in paragraph (c) of this section [see paragraph c quoted below], the consent form may be either of the following:

    A written consent document that embodies the elements of informed consent required by Sec. 46.116. This form may be read to the subject or the subject’s legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; OR

    • A short form written consent document stating that the elements of informed consent required by Sec. 46.116 have been presented orally to the subject or the subject’s legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.

    NOTE: In order to ensure that all subjects or LARs receive the same information sufficient to understanding the research study they are being asked to join, the VCU IRB does not permit use of a short written consent document as described in 45CFR46.117(b)2 above.

  2. Waiver of Documentation of Informed Consent:

    The VCU IRB cannot waive documentation of informed consent under 45 CFR 46.117(c)(1) for FDA-regulated research.

    A waiver of documentation of informed consent may be requested by the IRB under 2 (limited) circumstances, as provided below:

    45 CFR 46.117(c)
    (c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
    • That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; OR
    • That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

    In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

    NOTE: if all of the required elements of informed consent are waived by the IRB, then documentation of consent is also waived, and need not be requested by the PI. However, if only some elements of informed consent are waived, both the PI and IRB reviewer are to consider whether documentation of those remaining elements is indicated in order to protect subjects and/or to allow a formal expression of voluntary participation.

    IMPORTANT WAIVER NOTE: Limitations of waiver of documentation include the following:

    1. The VCU IRB cannot waive documentation of informed consent under 45 CFR 46.117(c)(1) for FDA-regulated research.
    2. The VCU IRB cannot waive documentation of informed consent under 45 CFR 46.117(c)(2) for FDA-regulated research.
    3. For Exception from Informed Consent in Emergency Research, see special VCU IRB requirements at VCU IRB WPP XVII-16.
    4. If a PI requests waiver of informed consent documentation, the VCU IRB will review a written summary document that the investigators will use to guide them through the informed consent discussion/process (and will serve as an information guide to participants).

    Additional Guidance Regarding Waiver of Documentation:

    1. If a waiver of documentation is granted, research participants do not necessarily retain any document related to the research to which they have consented. In order to allow for the participant to ask questions, report concerns and unanticipated problems, the VCU IRB recommends that the PI provide the participant with contact information on a card. This contact card may or may not reveal the identifying features of the study. However, the participant may wish to retain a copy of the approved informed consent document, even if he/she does not formally sign it.
    2. The PI and/or research staff will document the participant's consent, along with the date, any witnesses, and the name of the person conducting consent in the study files.
    3. Waiver of documentation need not apply to each and every participant in the study. In fact, even if a waiver of documentation has been approved by the VCU IRB for reasons of decreasing risk of participation, some participants may wish to sign and retain a copy of the informed consent document. They should be given the choice of doing so.
  3. Required Signatures

    VCU enforces the following requirements for all consent documents (beyond summary documents) unless waiver of all consent elements or waiver of documentation is approved:

    1. Subjects must sign and date the consent form, as required by the regulations.
    2. The Principal Investigator or equally qualified Sub-Investigator must sign and date consent forms approved by the IRB because it is the responsibility of the investigator to ensure that consent is obtained from each subject as required.
    3. The IRB also accepts the signature of a sub-investigator for the purpose of fulfilling this requirement. If a sub-investigator has signed the consent form, the investigator does not need to sign the form.
    4. The IRB recognizes that the investigator or sub-investigator is not always present when consent is obtained, and therefore does not expect that the date of the subject’s signature will be the same as the date of the investigator’s signature.
    5. In order to meet International Conference on Harmonization (ICH) guidelines, a dated signature line for the person conducting the informed consent discussion is required by the IRB.
    6. For signature considerations related to the involvement of children in research, see WPP XV-1 Permissible Categories (for Research with Children). In summary, the IRB must consider whether one or two parents/guardians must sign the parental permission form for Categories 404 and 405. The form should allow signature lines for 2 signatories even if only 1 parent/guardian must sign.

References

45 CFR 46.117
21 CFR 50.27
VCU IRB WPP XI-1 Consent Process, Elements, Waiver of Elements, and Modification
VCU IRB WPP XVII-16 Emergency Research Requirements (and Waiver of Consent)