Guidance

Informed Consent Procedures Using Electronic Systems and Remote Use of Paper Documents

Mar 27, 2020 2:00 pm

Updated April 9, 2020

Electronic and remote informed consent procedures are permitted by IRBMED and must meet the same regulatory and institutional requirements of an in-person paper-based informed consent process. This guidance is intended for research studies that require signed informed consent.

Electronic informed consent (eIC) refers to the use of electronic processes and systems (i.e., information presented via computers, tablets, websites, smartphones) to convey study information and/or to document informed consent from a participant or Legally Authorized Representative (LAR). Research studies using eIC must comply with federal Health and Human Services (HHS) requirements at 45 CFR 46 and the University of Michigan Human Research Protection Program Operations Manual. Research projects that are subject to Food and Drug Administration (FDA) regulations must comply with FDA requirements at 21 CFR 11, 50, and 56. Research projects using or disclosing Protected Health Information (PHI) must comply with Health Insurance Portability and Accountability Act (HIPAA) requirements at 45 CFR 160 and 164.  The participants and the study team are not necessarily remote from each other.

Remote informed consent procedures (i.e., the participant and the study are physically separated from each other) may be still conducted with the use of paper informed consent materials when it is not possible to develop an eIC process due to time constraints or technological limitations.  The section titled “General Requirements and Considerations for Remotely Obtaining Informed Consent Using Paper Documents” provides guidance for these situations.

  • General Requirements and Considerations for Electronic Informed Consent (eIC)

    1. The eIC must contain all elements of informed consent required by HHS regulations at 45 CFR 46.116 (the IRBMED standard informed consent template addresses these HHS requirements).
      1. If a research study is FDA regulated, subject to HIPAA, or includes children, see additional guidance below.
    2. The electronic format should be easy to navigate for the targeted study population. Strategies that enhance comprehension of information are permitted, including but not limited to:
      1. Narration of text
      2. Hyperlinks to additional information
      3. Images, such as pictures and charts
      4. Videos
    3. All relevant information about study procedures should be presented in the eIC prior to the participant documenting their consent.
    4. There must be sufficient opportunity for participants to consider whether to participate. As such, the eIC should allow the opportunity for the participant to stop and continue later.
    5. The principal investigator and/or study team members designated to obtain informed consent are responsible for ensuring that a valid signature is obtained before the participant conducts study activities.
      1. The principal investigator and/or study team must assure that informed consent has been appropriately obtained, even if using an electronic system.
    6. The eIC process between a participant and the consenting study team member can take place either in-person or remotely, prior to having the participant sign the consent.
      1. If done in-person, the study team member(s) will verify the participant’s identification, review the eIC content, address questions, and witness signing of the eIC.
      2. If done remotely, there must be a method for participants to have discussions with the study team (e.g., messaging, telephone calls, video conference, chat) prior to documenting consent. If discussions are not in real time, participants should be informed of how they will receive responses to questions. Participants should be reminded to use a private location to help ensure privacy and confidentiality. Additionally, the electronic system must include a method to ensure that the participant or LAR electronically signed the form, and not another person.
    7. Electronic methods to capture the signature of the participant or LAR are permitted. The Office for Human Research Protections (OHRP) permits electronic signatures if such signatures are legally valid within the jurisdiction where the research is to be conducted.
      1. For studies conducted in the State of Michigan, the Michigan Uniform Electronic Transactions Act 305 of 2000 defines an “electronic signature” as “an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record.” (MCL 450.832)
    8. The person electronically signing the eIC must be given a copy of the eIC.
      1. The copy provided can be paper or electronic (email, text, photograph, other electronic format).
      2. If hyperlinks are included in the eIC, the links must be maintained through completion of the study.
      3. If a paper copy of the eIC is provided, any study-specific hyperlinked information should be provided on paper.
    9. eIC can be used either to supplement or replace paper-based informed consent. OHRP and FDA regulations permit the flexibility of using electronic and paper informed consent methods independently or in combination throughout the course of the study.
    10. Amendments to an existing eIC process are not required to be electronic. Depending on the circumstances of an amendment, it may be appropriate to use a paper-based method to convey new information to a participant, such as a mailed document.
  • Additional Requirements and Considerations for FDA-regulated Studies using Electronic Informed Consent (eIC)

    Updated April 9, 2020

    1. The eIC must contain all elements of informed consent required by FDA regulations at 21 CFR 50.25 (the IRBMED standard informed consent template addresses these FDA requirements).
    2. FDA regulations found at 21 CFR 11 set forth the criteria under which FDA considers electronic signatures to be valid and generally equivalent to a handwritten signature executed on paper.
      1. Specific FDA electronic signature requirements are found at 21 CFR 11.10: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=11.10
      2. FDA does not mandate or specify any particular methods for electronic signatures. Methods permitted by FDA includes but is not limited to:
        • Digital signatures
        • Computer-readable ID cards
        • Biometrics designed to ensure that they cannot be used by anyone other than the participant
        • Username and password combinations
    3. The electronic system used for eIC must capture and record the date that the participant or LAR provides consent.
    4. Participants should be provided a copy of the eIC. FDA regulations do not require that the participant’s copy include a signature, however, FDA recommends that a copy of the signed informed consent form that includes the date when the eIC was signed be provided to the participant or LAR.
    5. Prior to initiating research activities with a participant, the identity of an individual must be verified, as required by 21 CFR 11.100(b). Methods permitted by FDA include but are not limited to:
      1. Use of birth certificate
      2. Government-issued passport
      3. Driver’s license
      4. Use of security questions
    6. Study teams should obtain a statement from the vendor of the electronic system that describes how the signature is created and that the system meets the requirements of FDA regulations at 21 CFR 11.
      1. The electronic system must have restricted access and be secure. Additionally, the system should ensure confidentiality regarding participant’s identities, study participation, and other personal information.
      2. If SignNow is used, a vendor statement is not required.
    7. If an FDA-regulated study is subject to an FDA site inspection, the FDA must be granted access to all site-specific versions of the eIC (initial version and all amended versions) and all eICs signed by participants.
  • Additional Requirements and Considerations for Research with Children using Electronic Informed Consent (eIC)

    1. An eIC process can be used to obtain parental permission from parents and guardians of child participants.
      1. The electronic parental permission process should follow the same requirements and considerations of informed consent outlined in the sections above.
    2. Assent of children can be obtained using a process consistent with eIC. If appropriate, the study team can also request a waiver of assent or provide justification that assent is not necessary due to the age or status of child participants.
      1. Any assent process conducted electronically should use electronic means that are age-appropriate and does not impede the capability of children to provide assent.
      2. Language and presentation of electronic assent should be understandable to children in the targeted age population.
      3. Age-appropriate means of documenting assent must be used, or justification for why documentation of assent is unnecessary should be provided.
    3. If the research with children is FDA-regulated, child participants may lack documentation to verify identity (e.g., driver’s license, passport, etc.). It may be reasonable for parents or guardians to initially document the child’s assent, which can then be verified during the first study visit.
  • Requirements for Obtaining Electronic Informed Consent (eIC) for Use or Disclosure of Protected Health Information (PHI)

    Updated April 9, 2020

    1. If the research study will use or disclose PHI, the eIC used for the informed consent process must comply with HIPAA Privacy, Security, and Breach Notification Rules at 45 CFR 160 and 164.
      1. Safeguards of the electronic system used for eIC with should include either:
        • Encryption of participants’ information, or
        • Documentation of measures equivalent to encryption with justification for why encryption is not possible.
    2. HIPAA authorization to use or disclose PHI is permitted to be obtained electronically, if the electronic signature is a valid signature under applicable laws and regulations.
    3. Participants or LARs must be provided with a copy of the signed eIC.
    4. Study teams should obtain a statement from the vendor of the electronic system used for eIC that indicates compliance with HIPAA Privacy, Security, and Breach Notification Rules.
      1. If SignNow is used, a vendor statement is not required.​
  • General Requirements and Considerations for Remotely Obtaining Informed Consent Using Paper Documents

    1. There may be situations where a study team does not have an eIC process that complies with all requirements outlined above, but they still need to conduct the informed consent process remotely or with limited contact with participants (e.g., COVID-19 patients). In these situations, a study team must develop a process that includes the following:
      1. Method used to provide an informed consent document to a participant or LAR. Methods permitted include, but is not limited to:
        • Mailing a paper informed consent document to a participant or LAR
        • Having clinical staff (in lieu of the study team) give a paper informed consent document to a participant or LAR
      2. Method used to address questions from a participant or LAR prior to signing the informed consent document. Methods permitted include, but is not limited to:
        • A conversation via telephone
        • A conversation via telehealth or other secure video technology
        • Use of chat technology
      3. Description of how a participant or LAR will send back a signed informed consent form. Methods permitted include, but is not limited to:
        • A participant or LAR signs a paper informed consent document, takes a picture of the signature page via a smartphone or camera, and sends the picture of the signature back to the study team
        • A participant or LAR scans a signed informed consent document and electronically returns to the study team
        • A participant or LAR faxes a signed informed consent document back to the study team
      4. Method for a study team member to document that informed consent was obtained from the participant or LAR, including how the study team member will sign the informed consent document.
  • IRBMED Submission Requirements

    Updated April 9, 2020

    1. IRBMED requires submission of all study-specific informed consent information, including when study teams propose the use of remote informed consent or the use of eIC.
    2. The following should be provided to IRBMED for eIC review:
      1. Copies of all electronic eIC or electronic assent forms (such as print versions of forms)
      2. Copies of any study-specific information linked to in the electronic forms
      3. Any supplemental information used in the eIC process, such as videos and images. A list of acceptable file types can be found here: https://documentation.its.umich.edu/node/1082
      4. If the study is FDA-regulated, study teams should provide a statement from the vendor of the electronic system that describes how the signature is created and that the system meets the requirements of 21 CFR 11.
      5. For studies using or disclosing PHI, study teams should also obtain a statement from the vendor of the electronic system used for eIC with HIPAA authorization that indicates compliance with HIPAA Privacy, Security, and Breach Notification Rules.
        • If SignNow is used, a vendor statement is not required.
        • If a study team is unable to obtain a statement that the electronic system is HIPAA compliant, the IRBMED submission should describe how the participant or LAR will be informed that the eIC system does not comply with HIPAA regulations and how the participant or LAR will be asked to affirm their intention to proceed with the eIC process.
    3. The following should be provided to IRBMED for remote consent using paper informed consent documents (see “General Requirements and Considerations for Remote Informed Consent Using Paper Documents” above):
      1. Method used to provide an informed document to a participant or LAR.
      2. Method used to address questions from a participant or LAR prior to signing the informed consent document.
      3. Description of how a participant or LAR will send back a signed informed consent form (e.g., by mail, fax, or as an electronic image).
      4. Describe the method for a study team member to document that informed consent was obtained from the participant or LAR, including how the study team member will sign the informed consent document.
Questions?

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Edited By: bpsea@umich.edu
Last Updated: April 9, 2020 10:00 AM