Guidance

Telephonic Consent

IRBMED
Jun 5, 2017 11:00 am

In most cases, a potential research subject (or subject's representative) must be given an explanation of the protocol, including its risks, benefits, and alternatives. The subject's voluntary and un-coerced choice to participate must usually be documented by the subject's signature on the approved consent form. The Department of Health and Human Services has, however, developed special rules permitting an IRB to approve, under limited circumstances, alternative forms of consent or waiver of documentation of consent.

Note: Waiver of documentation means that informed consent must still be obtained from the study subjects.  This consent does not, however, need to be documented through a written instrument.  For more information, click here.

  • Waiver of Standard Documentation Requirements: Special Rules for "Telephonic" Consent

    CONSENT PROVIDED BY THE SUBJECT

    In order to approve such a waiver of documentation, the proposed research project must meet one of the following two situations.

    1.  For non-FDA regulated projects, the IRB must find either:

    The research presents no more than minimal risk of harm to subjects and that the research involves no procedures for which written consent is normally required outside of the research context.

    OR

    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.  In this case, each subject must be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes must govern.

     

    2.  For FDA regulated projects, the IRB must find:

    The research presents no more than minimal risk of harm to subjects and that the research involves no procedures for which written consent is normally required outside of the research context.

    When the consent documentation requirement is waived, the IRB may require the investigator to provide the research subject with a written statement concerning the research.  When making a request to use telephonic consent, the telephone script (the planned text to be used by the researcher making a call) must be included in the application for IRBMED approval.

     

    In order to obtain valid telephonic consent, an investigator will need to follow these steps:

    • Obtain a waiver of documentation of consent.
    • Read the informed consent script over the phone.
    • Discuss questions with the subject.
    • Research may begin only after the subject consents.

    CONSENT PROVIDED BY THE SUBJECT’S REPRESENTATIVE

    The IRB may also approve a telephonic consent procedure where the consent is provided by the subject's legally authorized representative (LAR).  Typically, this process will involve the investigator doing the following:

    • Mail, fax, or email the informed consent document to the LAR.
    • Conduct a consent interview by phone while the LAR has the document in hand.
    • Have the LAR sign and return the signed document to the investigator by mail, fax, or email before the subject is enrolled in the study.

    In cases where the subject’s representative is used, a non-interested, third-party witness who is not connected to the study (such as a hospital clinical operator) should monitor the consent process.  The name of the witness and the time and date of the consent conversation should be recorded in the study record.

    Note: Waiver of Documentation is not necessary for obtaining telephonic consent by a subject’s representative.

    STUDIES WITH PROTECTED HEALTH INFORMATION (PHI)

    For studies involving PHI, IRBMED will additionally need to make the following determinations:

    • There is no more than minimal risk to the privacy of individuals.
    • The research could not practicably be conducted without the waiver of consent or waiver of documentation of consent.
    • The research could not practicably be conducted without the requested use or disclosure of PHI.

    Note: If you receive either a Waiver of Informed Consent or a Waiver of Documentation of Informed Consent, you will also need to obtain a Waiver of HIPAA Authorization.  For more information regarding Waiver of HIPAA Authorization, click here.

  • ADDITIONAL INFORMATION

    For more details on the criteria that must be met in order for the IRB to approve a telephonic consent process, please review the Waiver or Alteration of Written Informed Consent under OHRP, FDA, and HIPAA Regulations.

     

  • TELEPHONIC CONSENT TERMS

    Representative

    The subject's legally authorized representative ("LAR"); a person recognized by law because of a spousal or familial relationship or by legal documentation (such as a “Power of Attorney”) to make decisions for another patient and/or subject.  Please consult with the Health System Legal Office for guidance regarding who may serve as an LAR.

    Practicably

    Federal regulations do not define the word 'practicably'.  Black's Law Dictionary, on which courts sometimes rely in interpreting legislative or administrative agency intent, defines the term as, "reasonably capable of being accomplished; feasible".

    Minimal risk to the subjects

    The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

    Minimal risk to the privacy of individuals

    Under HIPAA, investigators must take steps to minimize not just risks to subjects but risks to their privacy considered separately.

    Protected Health Information (PHI)

    Protected Health Information (PHI) - Includes information that:

    • is sent or stored in any form;
    • identifies the patient or can be used to identify the patient;
    • is created or received by a covered entity (e.g. hospital, doctor, dentist, health plan);
    • relates to a patient's past, present and/or future treatment and payment of services.

    USE - generally refers to how PHI is handled (internally)

    DISCLOSURE - generally refers to how PHI is shared externally.

     

    Approved by the IRBMED Chairs and Director on 3-29-2011
    Updated on Website on 6/5/2017

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: sophiach@umich.edu
Last Updated: May 30, 2018 10:00 AM