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5.3 Use of a Telephone Consent Process

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for use of remote informed consent process. For the purpose of this policy remote consent includes telephone, video-conferencing, or use of desktop, mobile or web-based applications or similar technologies.

2.0 Policy

  • 2.1. It is the policy of the Organization that remote consent may be used in both clinical and non-clinical research, at the discretion of the convened IRB, or of a qualified expedited reviewer (if the research or change in protocol qualifies for expedited review), provided such communication satisfies requirements of HHS regulations at 45 CFR 46.116 and 45 CFR 46.117 and FDA regulations at 21 CFR 50.20 and 21 CFR 50.27, and satisfies the additional requirements in the policy.

    • 2.1.1. The convened IRB or a qualified expedited reviewer may authorize use of remote consent or documentation for new subjects if:

    • 2.1.2. Enrollment of new subjects provided the research constitutes no more than minimal risk, OR

    • 2.1.3. Screening of new subjects to determine eligibility for a greater than minimal risk study, provided the screening procedures are all minimal risk. In this case the subject must be re-consented in person before performance of any greater than minimal risk research interventions, or any additional screening procedures conducted within the Organization.

  • 2.2. It is the policy of the Organization that remote consent may be used in both clinical and non-clinical research, at the discretion of the convened IRB, or of a qualified expedited reviewer (if the research or change in protocol qualifies for expedited review), OR on a single subject basis, at the discretion of the IRB Executive Chair or designee, provided such communication satisfies requirements of HHS regulations at 45 CFR 46.116 and 45 CFR 46.117 and FDA regulations at 21 CFR 50.20 and 21 CFR 50.27, and satisfies the additional requirements in the policy.

    • 2.2.1. The convened IRB or a qualified expedited reviewer may authorize use of remote consent or documentation for new subjects, or the IRB Executive Chair or designee may authorize use of remote consent or documentation for a single subject if:

      • 2.2.1.1. Direct face-to-face contact with the research staff would place an unreasonable burden on the subject (for example, because of distance), OR

      • 2.2.1.2. Requirement for direct face-to-face contact would prohibit enrollment of a potential subject in research with the prospect of direct benefit, OR

      • 2.2.1.3. Provision of new information to the subject would be inappropriately delayed by requiring direct face-to-face contact with the research staff.

3.0 Process for Utilizing Remote Consent

  • 3.1. Enrollment of new subjects in clinical research

    • 3.1.1. The informed consent form (as well as all protocol related ancillary materials) and a copy of “The Rights of Research Subjects” and “What Do I Need to Know?” must be provided to the subject for review prior to the remote consent process. These items can be provided to the subject in paper form by mail or fax, in PDF or equivalent form electronically, or through RSS or another desktop, mobile or web-based application remotely.

    • 3.1.2. The process of consent will be conducted as per the requirements of HRPP policy 5.1 (Obtaining Informed Consent from Research Subjects), HHS regulations (45 CFR 46.116(a)) and FDA regulations (21 CFR 50.20).

    • 3.1.3. If the subject agrees to participate in the research or the screening:

      • 3.1.3.1. If the ICF is supplied in paper form the subject is instructed to sign and date the ICF and return the signed document to the investigator by mail, fax or a scanned copy via email.

      • 3.1.3.2. If the ICF is supplied in PDF or equivalent form the subject is instructed to print, sign and date the ICF and return the signed document to the investigator by mail, fax or a scanned copy via email.

      • 3.1.3.3. If the ICF is supplied remotely through RSS or another desktop, mobile or web-based application, the subject is instructed to sign through that application.

      • 3.1.3.4. If the signed ICF (noted in sections 3.1.3.1.or 3.1.3.2 above) cannot be collected by the investigator, the subject may supply a photograph of the ICF, OR a dated attestation by a witness who participated in the call and by the investigator that the subject confirmed that he/she agreed to participate in the study and signed the informed consent.

      • 3.1.3.5. In all cases, the investigator must verify the identity of the person signing the form or providing the electronic signature. Verification of identity and signature can be accomplished by direct (or video) observation of the process of signing, or by using information from some form of official identification, such as a birth certificate, a government-issued passport, or a driver’s license, or via security questions, or via a digital signature such (per FDA regulations at 21 CFR part 11, and OHRP guidance), or by the written attestation of a witness to the signature.

      • 3.1.3.6. No research interventions (including screening) can be conducted until a signed copy of the ICF has been received by the investigator by email, fax or mail except when specifically authorized by the IRB or by the Executive Chair or designee.

      • 3.1.3.7. The ICF must be signed and dated by the investigator upon receipt of the document with a note added on the form which explains the lapse in time between signatures (for example, “received in the mail 10/30/08”, “remote consent obtained 10/27/08”).

      • 3.1.3.8. A copy of the ICF signed by the investigator must be provided to the subject (unless the subject has the ability to print the signed ICF through the desktop, mobile or web-based application.

    • 3.1.4. If the research satisfies the requirement for waiver of documentation of informed consent under 45 CFR 46.117(c) the ICF does not need to be signed and returned by the subject to the investigator and research interventions may begin as soon as verbal consent is obtained. In addition, ICF does not need to be signed and dated by the investigator.

    • 3.1.5. The process of remote consent must be documented in the medical or individual study subject record, if applicable, or in a separate consent log. The documentation must include:

      • 3.1.5.1. The rationale for use of remote consent.

      • 3.1.5.2. The date and time of remote consent.

      • 3.1.5.3. Identification of all personnel involved in obtaining and documenting informed consent.

  • 3.2. Enrollment of new subjects in non-clinical research

    • 3.2.1. Remote Consent may be utilized for enrollment of new subjects provided the research constitutes no more than minimal risk OR the subjects are not required nor expected to come into personal contact with the researchers at any time during the conduct of the research.

    • 3.2.2. Procedure will be as per section 3.1 above.

    • 3.2.3. Some minimal risk survey only research may be eligible for waiver of the requirement for the investigator to obtain a signed informed consent form under 45 CFR 46.117(c)(1)(ii).

  • 3.3. Re-consent to disclose new information or protocol changes

    • 3.3.1. Remote Consent may be utilized for the purpose of disclosing new information which may relate to the subject’s willingness to continue participation in the research, or protocol changes that may affect the subject directly.

    • 3.3.2. Procedure will be as per sections 3.1 above.

    • 3.3.3. If new information requires immediate verbal transmission to the subject (for example, a serious adverse event, or significant change in protocol which is required immediately) the subject may be notified by phone prior to supplying the revised ICF. The phone conversation between the investigator and the subject should be witnessed by a member of the Organization not associated with the research. Written re-consent as per section 3.1 items B thru F should follow promptly.

  • 3.4. Enrollment of decisionally impaired subjects whose LAR is unavailable in person

    • 3.4.1. Remote Consent may be utilized for the purpose of enrolling decisionally impaired subjects whose LAR is unavailable in person, even if that research constitutes greater than minimal risk as long as there is the possibility of direct benefit.

    • 3.4.2. Procedure will be as per section 3.1 above.

    • 3.4.3. The phone conversation between the investigator and the LAR should be witnessed by a member of the Organization not associated with the research.

    • 3.4.4. Assent of the decisionally impaired person must be obtained as required in HRPP policy 4.6 (Research Involving Subjects with Impaired Decision-Making Capacity).

ADMINISTRATIVE APPROVAL:

BRUCE G. GORDON, MD

IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS

CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED JUNE 11,2020 (PREVIOUSLY TITLED POLICY: USE OF A TELEPHONE CONSENT PROCESS)

 REVISED JULY 27, 2018

 INITIAL JANUARY 12, 2016

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