Florence’s Compliance POV on eConsent in the U.S.A

By Sara Saunders, Policy Manager at Florence Healthcare

Florence eConsent enables users to take the traditional wet-ink consent process electronically, opening the door to remote consent workflows and more. In the US, requirements for the general consent process are outlined in 21 CFR parts 50 and 56 for FDA regulated studies, along with HHS requirements set forth in 45 CFR part 46. When utilizing electronic informed consent, FDA’s 21 CFR Part 11 sits on top of these regulations, outlining additional requirements specifically for electronic records and electronic signatures.  In 2016, the FDA posted a Guidance on the Use of Electronic Informed Consent, providing recommendations on the use of electronic systems to obtain informed consent. 

 Florence eConsent is compliant with all technical requirements of 21 CFR Part 11;  is compatible with the requirements outlined in 21 CFR parts 50 and 56, and 45 CFR Part 46; and fully conforms with the FDA’s Guidance on the Use of Electronic Informed Consent, along with other guidance documents that FDA has in place surrounding Part 11. 

Florence eConsent enables users to upload consent forms directly into the system for ease of use, allowing participants to review consent forms at their own pace and ask questions prior to signing via a compliant signature.  

When routing a consent form, clinical staff are able to assign additional signers similar to paper consenting workflows. 

• Legally Authorized Representatives (LARs) can be assigned to study participants who cannot consent for themselves
• Parental permission may be obtained and documented for pediatric participants
• Interpreters may be assigned to support consenting non-English speaking subjects as confirmation that all information was provided in the participant’s language

If a participant signed a paper form during their visit, users can also upload a scanned version of the form to Florence eConsent and utilize the certified copy feature to document the copy has the same information as the original version, in alignment with requirements for certified copies. 

OHRP and FDA regulations allow the use of electronic and paper informed consent methods independently or in combination, allowing the flexibility to use the consent workflow that is best for the participant when their consent is being obtained. 

Florence’s 21 CFR Part 11 compliance controls ensure that all forms uploaded into the system can be considered trustworthy, reliable, and generally equivalent to paper records. Forms stored within Florence eConsent meet the fundamental principles of data quality as outlined in ALCOA-C and ALCOA++ standards. 

If an Electronic Record is changed or modified, appropriate version controls are in place to ensure the changes do not obscure previously recorded information.  Clinical staff are able to manage consent form versions within the clinical portal, and only active forms can be sent to participants.

Regulations require that the person signing the informed consent be given a copy of the informed consent form, which can be done through participant portal access in Florence eConsent, or by downloading the consent form and providing a paper copy. 

To enable compliant workflows if any or all of the consent process takes place remotely and is not personally witnessed by study personnel, Florence eConsent provides options for sites to configure how they will verify participant identity in order to ensure that the person electronically signing the informed consent is the participant or the approved additional signer. 

OHRP and FDA regulations permit the use of electronic signatures when written informed consent is required. When a consent form is signed electronically in Florence eConsent, the resulting electronic signature meets the technical requirements to be considered trustworthy, reliable, and generally equivalent to handwritten signatures as outlined in 21 CFR Part 11. Upon completion of a signature in Florence eConsent, the following information is present and associated with that signature: 

• Printed name of the signer; 
• Data and time of that signature;
• Meaning of that signature; and 
• Optionally, the job title of the signer, if required by the Customer or Non-Customer. 

To provide more control over when participants and additional signers can sign forms, Florence eConsent has a signing gate on the level of individual participants. Clinical staff can enable signing only when it’s confirmed that the participant is fully informed and aware of the risks and benefits of the trial, and ensure all signers sign the consent form in the predetermined order. 

Florence recognizes that there are times when consent needs to be completed on-site, while maintaining compliant electronic workflows. For those who would rather provide consent in person, sites can now explain the informed consent form to the participant; and then hand over a tablet to capture a stylus signature on an electronic form. With access controls built into Florence eConsent, the person obtaining consent can then attest to the informed consent process via a Part 11 compliant electronic signature. 

Stylus signatures are considered handwritten signatures under US FDA Part 11. Due to this, the signature itself is out of scope for Part 11 compliance, but it is completed in a Part 11 compliant system, with appropriate access controls, audit trails and validation procedures in place. When utilizing a stylus signature, signing gate must be enabled to ensure signatures are obtained sequentially. 

To ensure compliance, stylus signatures should only be utilized during the on-site consenting process. 

A secure, computer-generated, and time-stamped audit trail is automatically captured within Florence eConsent to record the date and time of user entries and actions that create, modify, or delete electronic records.

As a closed system, only authorized individuals can access Florence eConsent via the clinical or participant portal. Authority checks are in place to ensure that only authorized individuals can perform specific tasks within Florence eConsent. 

In case of a regulatory inspection, authorized individuals can grant the FDA or other inspectors access to records in Florence eConsent, enabling access to required electronic records.

Florence eConsent is systematically validated to ensure they are suitable for intended use. In addition to the extensive testing completed by Florence, we provide customers with a User Acceptance Testing template and Part 11 checklist to ensure the system is validated for intended use.

Florence eConsent offers a secure platform to process personal data and information and Florence encrypts data both in transit and at rest to ensure HIPAA requirements are met.

We hope this information was helpful to understand how Florence eConsent can be used to support your workflows!

If you have any questions regarding how Florence eConsent can be used in compliance with applicable regulations during the informed consent process, please reach out to info@florencehc.com. 

Note: This information is an overview from Florence’s compliance team and is not meant to serve as official guidance nor replace validation and review of appropriate regulations.