MSU HRPP Manual Section 6-4-G
Electronic Consent
Electronic informed consent refers to the use of electronic systems and processes that may employ multiple electronic media, including text, graphics, audio, video, podcasts, passive and interactive Web sites, biological recognition devices, and card readers, to convey information related to the study and to obtain and document informed consent. Use of electronic consent must meet all the IRB requirements for informed consent in the protection of human subject regulations (e.g. 45 CFR 46, 21 CFR 50, 21 CFR 56). For studies regulated by the U.S. Food and Drug Administration (FDA), FDA’s requirements for electronic records / electronic signatures must also be met (e.g., 21 CFR 11). See HRPP Manual 6-4-H “Electronic Signature” for requirements regarding electronic signature.
An electronic consent must contain all elements of informed consent required by IRB regulations (e.g. 45 CFR 46.116 and 21 CFR 50.25). The information must be in language understandable to the potential subject or the subject’s legally authorized representative and conveyed in a manner that minimizes the possibility of coercion or undue influence regarding the subject’s decision to participate in a study (45 CFR 46.116 and 21 CFR 50.20). Understandable means that the information presented to subjects is in a language and at a level the subject can comprehend, including an explanation of scientific and medical terms. To ensure that the electronic informed consent is presented appropriately and that subjects will have enough time to dedicate to the electronic informed consent process, the subjects should be informed of approximately how long the process will take and what information will be presented to them.
The IRB must review and approve the electronic consent and any amendments to the electronic consent that the subject will receive and view. The IRBs must maintain and retain copies of materials that have been reviewed in accordance with 45 CFR 46.115 and 21 CFR 56.115.
MSU’s Office of the General Counsel will be consulted as needed if questions arise regarding legal requirements for electronic consent.
Materials Required for Review
When submitting an application to the IRB for review, the investigator must submit the electronic informed consent and any amendments to the electronic informed consent that the subject will receive and view. This includes all forms (electronic and paper) and informational materials, including any videos and web-based presentations, which the subject will receive and view during the electronic informed consent process.
The investigator should consider (as appropriate to the research):
- Whether assistance will be provided to subjects in using the electronic informed consent technology
- Use of any optional questions or methods used to gauge subject comprehension of key study elements
- Procedures to ensure that electronic documents can be archived appropriately and all versions of the IRB-approved electronic informed consent can be retrieved easily
IRB Considerations
While the investigator and/or study sponsor may request use of electronic consent technologies, the IRB will determine if the selected method is appropriate or if additional formats for consent may be needed. In the process of evaluating use of an electronic technology, the IRB considers and/or reviews the following:
- Whether electronic consent is appropriate for all subjects
- Whether the electronic informed consent provides sufficient opportunity for the subject to consider whether to participate
- Usability of the electronic informed consent materials to ensure that they are easy to navigate
- If the program uses hyperlinks to convey study-related information, the contents to which subjects are referred in order to determine if the study-related information that has been supplied is accurate and appropriate.
- If the study is regulated by the FDA:
- How the identity of the person who will be electronically signing will be verified
- If the study involves children, how the identity of the child will be verified
Because Web sites are often modified over time, IRBs must maintain the version of the Web site information that contains the study-related information that the IRB reviews and approves, either electronically or as a hard copy (see 45 CFR 46.115 and 21 CFR 56.115).
Some or All Subjects
Electronic informed consent may be used to either supplement or replace paper-based informed consent processes in order to best address the subject’s needs throughout the course of the study. For example, some subjects may prefer one method over another. Other subjects may have difficulty navigating or using electronic systems because of, for example, a lack of familiarity with electronic systems, poor eyesight, or impaired motor skills. In such cases, the electronic informed consent process may not be appropriate for these subjects. Therefore, subjects should have the option to use paper-based or electronic informed consent methods completely or partially throughout the informed consent process.
Opportunity to Consider Whether to Participate
Whether the electronic informed consent is obtained from the subject on-site or remotely, the electronic informed consent process must provide sufficient opportunity for the subject to consider whether to participate (see 45 CFR 46.116 and 21 CFR 50.20). The investigator should have methods in place to ensure that the electronic informed consent process allows subjects the opportunity to consider whether or not to participate and to ask questions about the study before signing consent as well as at any time during the subject’s involvement in the research. This may be accomplished by in-person discussions with study personnel or through a combination of electronic messaging, telephone calls, video conferencing, or a live chat with a remotely located investigator or study personnel. When live chat or video conferencing is used during the electronic informed consent process, investigators and study personnel should remind subjects to conduct the electronic informed consent discussion in a private location to help ensure privacy and confidentiality.
Subject Verification
OHRP recognizes that it may not be possible or necessary for all types of research covered by 45 CFR part 46 to verify that the person signing the informed consent is the subject or the subject’s legally authorized representative who will be participating in the research study. OHRP encourages investigators to apply a risk-based approach to the consideration of subject identity. For example, social behavioral minimal risk research will not typically warrant such verification. In addition, informed consent may be waived for minimal risk research meeting the requirements at 45 CFR 46.116(d).
FDA
If the study is regulated by the FDA, if any or all of the consent process takes place remotely and is not personally witnessed by study personnel, the electronic system must include a method to ensure that the person electronically signing the informed consent is the subject who will be participating in the research study or is the subject’s legally authorized representative (see 21 CFR 11.100(b)). Examples of various methods that could be used include verification of a state-issued identification or other identifying documents or use of personal questions, biometric methods, or visual methods.
Significant New Findings
When appropriate, the electronic informed consent must contain a statement that significant new findings developed during the course of the research that may affect the subject’s willingness to continue participation will be provided to the subject or the subject’s legally authorized representative (see 45 CFR 46.116(b)(5) and 21 CFR 50.25(b)(5)). If an update or amendment to an electronic informed consent is necessary and could affect the subject’s willingness to continue participation in the study, the electronic informed consent process must provide sufficient opportunity for the subject to consider whether to continue participation (see 45 CFR 46.116 and 21 CFR 50.20).
Revised Consent
The investigator must obtain IRB approval for any subsequent modifications to the study-related information, whether electronic or in hard copy. If the electronic informed consent is updated or amended, the subject should be given sufficient opportunity to ask questions about the amended contents. In such cases, the subject or the subject’s legally authorized representative must sign the amended electronic informed consent before the subject continues in the study (see 45 CFR 46.117(a) and 21 CFR 50.27). 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. Thus, amendments to the electronic informed consent do not need to be electronic in nature and can instead rely on more traditional means, such as paper-based amendments or postal mail, for conveying and transmitting the information to the subject.
Research Involving Children
When approving an electronic informed consent assent process, an IRB should consider whether the capability of a child to assent may be affected by the method used to obtain and/or document child assent. For example, if assent would otherwise be required, the method used to obtain electronic informed assent should not impede the child’s capability to provide assent. The language and presentation of information must be understandable to the child.
Record Retention
The electronic informed consent, the materials submitted to IRBs for review and approval, all amendments to the electronic informed consents, and all subject-specific signed electronic informed consents must be available for site visits and inspections. These should be available at the site either in electronic or paper form. The content of the electronic informed consent program or informed consent document and the corresponding informed consent of the subject or the subject’s legally authorized representative and the signature of a witness, where applicable, along with the date, where applicable, that the electronic informed consent was signed must be available for review. Any updates to the documentation should also be available for review.
FDA
FDA regulations do not specify a preferred method for archiving documents; however, the electronic informed consent process should incorporate procedures to ensure that electronic documents can be archived appropriately and that all versions of the IRB-approved electronic informed consent can be retrieved easily. All procedures must be in compliance with applicable FDA regulations for electronic records.
U.S. Health Insurance Portability and Accountability Act (HIPAA)
If the entity holding the subject’s personal information is a covered entity under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Public Law No.104-191) or acting as a business associate of a HIPAA-covered entity, the requirements in the HIPAA Privacy, Security, and Breach Notification Rules apply (see 45 CFR parts 160 and 164). For example, the subject’s information within an electronic system must be encrypted, unless the entity documents why encryption is not reasonable and appropriate in their specific circumstances and implements a reasonable and appropriate equivalent measure.
Use of IRB Approved Form
Investigators must use the electronic consent approved by the IRB. Typically, investigators must use a consent form that includes the IRB watermark to assure that the appropriate version of the consent form is being used. With electronic consent, it may not be possible to use a version of the consent that includes the IRB watermark. In such cases, the investigator is responsible for assuring that currently approved version of the electronic consent is used and may consider other methods to assure that the correct version is used (e.g., versioning, dating).
This policy and procedure supersedes those previously drafted.
Approved By: Vice President for Research and Innovation, 4-14-2023