Obtaining and Documenting Informed Consent

This policy describes how the UW-Madison IRBs evaluate the adequacy of informed consent documents and process in human participants research.

  1. To approve research that is not determined to be exempt, UW-Madison IRBs must determine that informed consent will be sought from each prospective participant or the participant’s legally authorized representative in accordance with the requirements of federal regulations, state law and institutional policies and procedures, or that a waiver or alteration of informed consent is appropriate.

  2. Unless a waiver of informed consent has been approved by the IRB, no investigator may involve a human being as a participant in research without obtaining the legally effective informed consent of the participant or the participant’s legally authorized representative.

    1. UW-Madison IRBs consider the informed consent process to begin when a potential research participant is first contacted.

    2. The nature and circumstances of the informed consent process and the consent documentation described in the protocol must:

      1. Provide sufficient opportunity for potential participants and representatives to consider whether to participate in the research.

      2. Minimize the possibility of coercion or undue influence of potential participants and representatives.

      3. Use language understandable to each potential participant or representative.

      4. Contain no exculpatory language through which the potential participant or their representative is made to waive or appear to waive any of the participant’s legal rights or release or appears to release the investigator, sponsor, institution or its agents from liability for negligence.

    3. Investigators should be sensitive, throughout the conduct of the research, to participants' understanding of the project and willingness to participate.

    4. New findings or changes made during the course of a research study may require the re-consenting of study participants.

  3. IRB Review of the Consent Process

    1. UW-Madison IRBs systematically evaluate the following factors when determining whether informed consent will be sought from each prospective participant or the participant’s legally authorized representative in accordance with the requirements of applicable federal regulations, state law and institutional policies and procedures:

      1. The nature and circumstances of the consent process in addition to the consent document.

      2. The qualifications and training of those who will conduct the consent interview.

      3. The timing of obtaining informed consent and of any waiting period (between informing the participant and obtaining the consent) that will be observed.

      4. Where the consent process will take place.

      5. Whether the consent form or script is worded so that potential participants can understand it. The language should be adjusted to an appropriate level for the particular participant population.

    2. When a potential participant’s understanding of the research may be impaired due to any of the above factors, the IRB will require modifications in the consent process.

  4. IRB Review of Consent Documentation

    1. When reviewing research, UW-Madison IRBs systematically evaluate whether the informed consent will be documented as required by the federal, local and state law, University policies, and, if applicable, FDA regulations.

    2. UW-Madison IRBs require informed consent be documented by the use of a written consent form approved by the IRB and signed by the participant or the participant’s legally authorized representative, unless the IRB has approved a waiver of documented consent in accordance with Section IV.F of this policy.

    3. When documentation of informed consent is required, all participants must sign and date the most current IRB-approved consent document. IRB approval and consent form version will be documented by a stamp on the first page of the consent form.

    4. The consent form or script should be worded so that potential participants can understand it. The language should be adjusted to an appropriate level for the particular participant population.

    5. Consent must be documented in one of the two following ways:

      1. IRB-approved written consent document that embodies the elements of informed consent required in 45 CFR 46.116(a)(1-8) and 21 CFR 50.25(a)(1-8).

        1. Before the consent document is signed, the investigator, or designee, must discuss the critical information that needs to be shared with the potential participant or legally authorized representative.

        2. The investigator, or designee, must give the potential participant or legally authorized representative adequate time to read the consent document and ask questions before it is signed (and dated if it is FDA-regulated research).

        3. A copy of the consent form must be given to the person signing the form.

      2. An IRB-approved “short form” written consent document stating that the elements of informed consent required by 45 CFR 46.116(a)(1-8) and 21 CFR 50.25(a)(1-8) have been presented orally to the participant or the participant’s legally authorized representative. This is generally allowed only in the case of illiterate subjects, blind subjects or subjects with limited capacity to understand English. Use of the short form requires the following:

        1. witness to the oral presentation;

        2. An IRB-approved written summary of what is to be said to the participant or the representative;

        3. The participant or the representative must sign the short form (and date the form if the research is FDA-regulated);

        4. The witness must sign the short form and a copy of the summary;

        5. The person obtaining consent must sign a copy of the summary; and

        6. A copy of the summary and a copy of the short form must be given to the participant or the representative.

      3. Signatures on the consent forms should be placed immediately below the text of the form.

      4. Each participant must be given a complete copy of the consent form.

      5. Investigators must keep a copy of the signed consent form on file for seven years following the completion of the research.

  5. Withdrawal of Consent for Research Subject to FDA Regulations

    1. When a subject withdraws from a study any data collected on the subject, up to the time of withdrawal, remains part of the study database and may not be removed. The consent document cannot give the subject the option of having data removed.

    2. An investigator may ask a subject who is withdrawing whether the subject wishes to provide continued follow-up and further data collection subsequent to their withdrawal from the interventional portion of the study. Under this circumstance, the discussion with the subject distinguishes between study-related interventions and continued follow-up of associated clinical outcome information, such as medical course or laboratory results obtained through non-invasive chart review, and address the maintenance of privacy and confidentiality of the subject's information.

    3. The investigator must obtain the subject’s consent for this limited participation in the study (assuming such a situation was not described in the original consent document). The IRB must approve the consent document.

    4. If a subject withdraws from the interventional portion of a study and does not consent to continued follow-up of associated clinical outcome information, the investigator must not access for purposes related to the study the subject's medical record or other confidential records requiring the subject's consent. However, an investigator may review study data related to the subject collected prior to the subject's withdrawal from the study, and may consult public records, such as those establishing survival status.

  6. Waiver of the Requirement to Obtain Informed Consent

    1. IRBs may grant a waiver of informed consent under 45 CFR 46.116 (or, if applicable, 38 CFR 16.116(d)) only when the IRB finds that research is not subject to FDA regulations and meets either of the following:

      1. The required conditions stated in 45 CFR 46.116(c) (or, if applicable, 38 CFR 16.116(d)):

        1. The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and

        2. The research could not practicably be carried out without the waiver or alteration.

      2. The required conditions stated in 45 CFR 46.116(d) or, if applicable, 38 CFR 16.116(d):

        1. The research involves no more than minimal risk to the subjects;

        2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;

        3. The research could not practicably be carried out without the waiver or alteration; and

        4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

    2. A waiver of informed consent will not be granted solely for the convenience of the investigator.

    3. For research subject to FDA regulations, a waiver of informed consent will be allowed only if research meets the criteria specified in 21 CFR 50.23, emergency use of a test article, or 21 CFR 50.24, planned emergency research.

    4. For research subject to the Family Educational Rights and Privacy Act (FERPA)

      1. waiver of informed consent to access personally identifiable information from student education records will be allowed only under the following circumstances:

        1. The information is student “directory information,” as defined in 34 CFR 99.3, or

        2. The information is not student “directory information,” as defined in 34 CFR 99.3, but the request meets the requirements of 34 CFR 99.31(a)(6)(i), in that the disclosure is to organizations conducting studies for, or on behalf of, educational agencies or institutions to: (A) develop, validate or administer predictive tests; (B) administer student aid programs; or (C) improve instruction.

        3. The disclosure of student education records must be to authorized representatives of the Secretary of the Department of Education or of State and local educational authorities in connection with an audit or evaluation of Federal or State supported education programs, as required by 34 CFR 99.31(a)(3).

  7. Alterations to the Required Elements of Consent

    1. UW-Madison IRBs may only approve an alteration of the required elements of consent when the IRB finds that research is not subject to FDA regulations and meets the required conditions stated in 45 CFR 46.116(c) or 45 CFR 46.116(d) (or, if applicable, 38 CFR 16.116(c) or 38 CFR 16.116(d)):

    2. An alteration of the required elements of informed consent will not be granted solely for the convenience of the investigator.

  8. Waiver of the Requirement to Obtain Documentation of Informed Consent.

    1. UW-Madison IRBs may only grant a waiver of documentation of informed consent under 45 CFR 46.117 (or, if applicable, 38 CFR 16.117) when the IRB finds that the research is not subject to FDA regulations and meets either of the following conditions:

      1. 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.

      2. 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.

    2. For research that is subject to FDA regulations, a waiver of documentation of informed consent will be approved only when the research meets either of the required conditions:

      1. The IRB may, for some or all subjects, waive the requirement that the subject, or the subject's legally authorized representative, sign a written consent form if it finds 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 the research context; or

      2. The IRB may, for some or all subjects, find that the requirements in 50.24 of this chapter for an exception from informed consent for emergency research are met.

    3. A waiver of the requirement for documentation of informed consent will not be granted solely for the convenience of the investigator.

    4. In cases in which the informed consent documentation requirement is waived, the IRB will determine whether written information regarding the research should be given to participants and, if so, will review the written information before it is given to the participants.

Adopted By: All Campus IRB Adoption Date: November 10, 2005
Revised: January 22, 2009
Revised By: Cross-Campus Human Research Protection Program Committee
Revision Date: November 11, 2015

Copyright © 2015 University of Wisconsin System Board of Regents

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Keywords:informed consent documentation   Doc ID:29762
Owner:Ryan M.Group:VCRGE and Graduate School
Created:2013-04-19 15:19 CDTUpdated:2015-12-10 13:50 CDT
Sites:VCRGE and Graduate School
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