1. Purpose
This SOP describes the policy for protocol submissions requesting to use electronic
systems to obtain informed consent and electronic HIPAA Authorizations (when applicable).
2. Scope
- Research conducted under the auspices of West Virginia University.
- Research protocols for which WVU
IS the IRB of Record
- Federally funded and non-federally funded research.
- Research protocols requiring Informed Consent from prospective participants (Full
Board and Expedited)
- Electronic Informed Consent completed in person or remote (where the consenting
researcher and the prospective participant are not in the same location)
- Research protocols requiring a signed HIPAA Authorization from prospective participants
The scope does not include:
- The electronic processes and materials used for the recruitment of prospective
participants
- Research protocols for which WVU
IS NOT the IRB of Record.
3. Responsibility
The PI is responsible for:
- Research protocols for which WVU IS NOT the IRB of Record.
- Ensuring that approved software and transmission methods are used for electronic
delivery of consent materials and surveys.
- Determining if electronic Informed Consent (eIC) or electronic delivery of surveys
is appropriate for the targeted population.
- Ensuring that prospective participants can use the electronic systems and providing
paper-based consent if required
- Submitting the required materials for paper-based, in-person, and remote informed
consent to the IRB for review and approval.
- Designing the consent process to include adequate time for the prospective participant/legally
authorized representative review of consent materials before asking for a signature.
- More than Minimal Risk (MMR) Research - Verifying the identity of the person who
will sign the consent form and obtaining the signature of the authorized person
on the research team who consented the participant.
4. Overview
Participant Considerations
- The participants should be informed of approximately how long the process will
take and what information will be presented to them to ensure that the eIC is
presented appropriately and that participants will have enough time to dedicate
to the eIC process
- Electronic materials should be easy to navigate, allowing the user to proceed forward
or backward within the system and to stop and continue at a later time. Hyperlinks
may be provided where helpful. The eIC may also incorporate electronic strategies
to encourage participants to access all consent materials before documenting
their consent
- Electronic informed consent may either supplement or replace paper-based informed
consent processes to best address the participant’s needs throughout the study.
For example, some participants may prefer one method over another. Other participants
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 eIC process may not be appropriate for these participants.
Therefore, participants should have the option to use paper-based or electronic
informed consent methods completely or partially throughout the informed consent
process.
- Paper-based consent must be hand delivered or sent to the participant/legally authorized
representative (LAR) using postal mail. Emailing the materials is not permitted.
- In some circumstances, it may be appropriate for PIs or research personnel to assist
participants in using the eIC technology. For example, research personnel may
help the participant/LAR navigate the consent by clicking on links for the participan
Remote/Onsite
- The PI cannot delegate authority to the electronic system to obtain informed consent
to the electronic system to complete the informed consent process. Whether part
or all of the eIC process takes place onsite or remotely, the responsibility
for obtaining informed consent remains with the PI and the research personnel,
to which responsibility has been appropriately delegated.
- The consent process may occur at the study site when both the PI and participant
are at the same location, or it may occur remotely (e.g., at the participant’s
home or another convenient venue) where the participant reviews the consent document
in the participant's home absence of the PI. The eIC materials may be provided
for both onsite and remote access.
- If the entire process takes place at the study site, the study personnel can personally
verify the participant’s identification, review the eIC content, answer questions
about the material, have follow-up discussions, and witness the signing of the
eIC.
- 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 participant
who will be participating in the research study or is the participant’s LAR (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.
- Whether the eIC is obtained from the participant onsite or remotely, the eIC process
must provide sufficient opportunity for the participant to consider whether to
participate (see 45 CFR 46.116 and 21 CFR 50.20). The PI should have methods
in place to ensure that the eIC process allows participants the opportunity to
consider whether or not to participate and to ask questions. This may be accomplished
by in-person discussions with study personnel or through a combination of telephone
calls or video conferencing with a remotely located PI or study personnel.
Ensuring Participant Understanding
- When telephone calls and video conferencing are used during the eIC process, PIs
and research personnel should remind participants to conduct the eIC discussion
in a private location to help ensure privacy and confidentiality.
- To assist the participant in understanding the material, the eIC may use interactive
electronic-based technology, including diagrams, images, graphics, videos, and
narration. The eIC should be appropriate for the intended audience, considering
the participant’s age, language, and comprehension level. The eIC may contain
various methods to help a PI assess the participant’s understanding of the information
presented during the eIC process. For example, the eIC may include optional questions
at any time during the eIC discussion that can be used to help educate the participant
about the information presented, as well as assess the participant’s understanding
of the informed consent materials. Such optional questions and other methods
may be used to gauge participant comprehension of key study elements and highlight
areas where the participant might need further explanation and discussion before
signing the informed consent to enter the study.
- WVU maintains an approved list of technology for interacting with participants/LARs.
Use of personal devices is not permitted, and texting messaging and chat are
not approved unless the capability is available within the approved technology
Electronic Signatures
- The procedure for eIC may include an electronic method to capture the signature
of the participant or the participant’s LAR. Federal OHRP and FDA regulations
permit the use of electronic signatures when written informed consent is required.
Federal OHRP permits electronic signatures if such signatures are legally valid
within the jurisdiction where the research is to be conducted.
- WVU General Counsel has approved the electronic signature capability for the approved
electronic consent systems.
Verification of Identity
- Compliance with the requirements in Part 11 is meant in part to prevent fraudulent
use. Therefore, the regulations found at 21 CFR part 11 require that an organization
verify an individual's identity before it establishes, assigns, certifies, or
otherwise sanctions an individual’s electronic signature or any element of such
electronic signature (see 21 CFR 11.100(b)). FDA regulations do not specify any
particular method for verifying an individual's identity and accepts many different
methods. For example, verifying someone’s identity can be done by using information
from some form of official identification, such as a birth certificate, government-issued
passport, or a driver’s license. In addition, the use of security questions to
confirm an individual’s identity can also be considered.
- Only the approved electronic systems may be used for eIC at WVU. The approved system
includes the capability for security questions for the participant to answer
and enter before accessing the informed consent form
Assent
- The eIC process can be used to obtain assent from pediatric participants (when
required) and parental permission from their parent(s) or guardian. The general
requirements for informed consent, found in 45 CFR 46.116 and 46.117 and 21 CFR
50.20, 50.25, and 50.27, (see also SOP 016: Documentation of the Informed Consent
Process) apply to parental permission, in addition to the requirements for permission
by parents or guardians and for assent by children found at 45 CFR 46.408 and
21 CFR 50.55.13 (see also SOP 015: Assent and Parental Permission). Therefore,
parental permission may be obtained and documented using the same eIC procedures
as would be used for informed consent.
- When approving an eIC 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 eIC assent should not impede the child’s capability to provide
assent. The language and presentation of information must be understandable to
the child. In addition, when the IRB determines that assent is required, it must
also determine whether and how assent must be documented (see 45 CFR 46.408(e)
and 21 CFR 50.55(g)). (See SOP 015: Assent and Parental Permission.)
- Depending on the method of identity verification used to satisfy the regulations
in 21 CFR part 11 for electronic signatures in FDA-regulated clinical investigations,
a child may lack the documentation necessary to verify their identity to prevent
fraudulent use of electronic signatures (e.g., driver’s license) (see Q7). Depending
on the clinical investigation, it may be reasonable for the parent to initially
document the child’s assent, which can then be verified when the PI first sees
the child.
Providing a Copy of the Consent Document
- HHS and FDA regulations require that the person signing the informed consent (i.e.,
the participant or the participant’s LAR or the parents or guardians of participants
who are children) be given a copy of the written informed consent form (45 CFR
46.117(a) and 21 CFR 50.27(a)) unless the requirement for documentation of informed
consent has been waived under 45 CFR 46.117(c) and 21 CFR 56.109(c)). Although
FDA regulations do not require that the participant’s copy include a signature,
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. The copy provided
to the participant can be paper or electronic and may be provided on an electronic
storage device or via email. If the copy provided includes one or more hyperlinks
to information on the Internet, the hyperlinks should be maintained, and information
should be accessible until study completion. Note that if the eIC uses hyperlinks
or other Web sites or podcasts to convey information specifically related to
the research, the information in these hyperlinks should be included in any printed
paper copy, if one is provided.
- The approved electronic consent systems at WVU provide the capability for the participant
to receive a copy of the consent form electronically. Depending on the system
used, the copy will be a participant downloaded PDF copy of the consent form
and a separate downloaded PDF of the electronic signature (participant/LAR only)
or a securely emailed copy of the consent form and signatures (participant/LAR
and consenting researcher) in one PDF file.
- When using eIC onsite (participant/LAR and researcher are in the same location),
consideration should be given to how the copy will be provided. If the system
requires a download and an institutional device is used, the PI should make arrangements
for paper copies to be provided after eConsent is completed.
Safeguarding Participant Information
- For FDA-regulated clinical research, the electronic system that supports the eIC
must be secure with restricted access (see 21 CFR 11.10 and 11.30) and should
include methods to ensure the participant’s identity, participation, and personal
information are secure and protected after informed consent has been obtained.
- If the entity holding the participant’s personal information is a covered entity
under the Health Insurance Portability and Accountability Act of 1996 (HIPAA)
(Public Law No. 104-191)15 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 participant’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.
- The electronic systems in use for informed consent are HIPAA compliant, and one
system is compliant with FDA access requirements and HIPAA requirements.
- WVU requires participants/LARs to agree to the use of email for the transmission
of the consent information from within the approved systems.
Transmission of eConsent Materials
- The transmission of all eConsent materials must occur using the approved systems.
The PDF of the approved Informed Consent document is uploaded into a WVU IRB
approved eTemplate and transmitted to the participant/LAR or the contents of
the document can be entered into the electronic system as text. Approval to waive
the watermark from the WVU IRB is required.
- WVU does not permit consent information to be transmitted using employee or personal
email accounts. Transmission may only occur from within the approved systems.
Electronic HIPAA Authorizations
- HIPAA authorizations may be obtained electronically, provided that the participant's
signature (or the participant’s personal representative) is a valid electronic
signature under applicable laws and regulations. The Electronic Signatures in
Global and National Commerce Act (ESign Act) (Public Law 106-229) addresses what
constitutes a valid electronic signature and provides that a signature may not
be denied legal effect because it is in electronic form. The HIPAA Privacy Rule
requires that when a covered entity seeks an authorization from a participant
(or a participant’s personal representative), the covered entity must provide
the individual with a copy of the signed authorization; this requirement also
applies where a HIPAA authorization is obtained electronically.
- WVU General Counsel has approved the electronic signature capability for the approved
electronic consent systems
- WVU provides the capability to send HIPAA Authorizations as standalone document
or within an Informed Consent Document
Protocol Submision
- The PI should submit copies and links of all forms (electronic and paper forms)
and informational materials, including any videos and Web-based presentations,
which the participant will receive and view during the eIC process with the protocol
application.
- The PI must obtain IRB approval for any subsequent modifications to the information,
whether electronic or in hard copy.
- It is recommended that the PI discuss plans for using unapproved products and methods
for eIC with WVU OHRP before finalizing development of the eIC to ensure that
the IRB agrees that such a format may be used for the applicable research for
obtaining informed consent
- eIC Worksheets are required to provide the IRB with adequate information regarding
the proposed eConsent process
5. References
WVU Policies:
SOP 012: Informed Consent
WV CTSI COE SOP #110-00 Informed Consent Process
WVU #1.11.3.3 Sensitive Data Policy
WVU #1.11.3.6 HIPAA Hybrid Entity Designation Policy
Informed Consent Form Templates (Word)
REDCap eTempaltes (REDCap Library)
Qualtrics eTemplates
Federal Regulations:
21 CFR Part 11
45 CFR 46.116, 46.117
45 CFR Part 160, Part 164 (subparts A and C) – Electronic HIPAA Authorizations
21 CFR 50.25
HIPAA Security Rule
E-Sign Act (Public Law 106-229) - Electronic HIPAA Authorizations
UETA - Electronic HIPAA Authorizations
AAHRPP:
Element II.3.F
Element II.3.G
