Best Practices for Using Electronic Informed Consent
Informed consent is the foundation of modern clinical research, with compliance being crucial to ensure patient safety and study transparency. In recent years, electronic informed consent (eIC) has become more widely adopted, with the potential to replace printed consent forms and improve the efficiency and effectiveness of the process.
For businesses looking for ways to demonstrate compliance and champion subject safety and transparency, e-consenting can help avoid breaches that may lead to a loss of confidence in company-sponsored studies. This in turn may affect participation and enrollment in clinical trials, which are key for product registration. Having a proactive plan and educating your potential subjects will help combat potential misconceptions and increase subject confidence.
Guidance from the FDA
The Food & Drug Administration's (FDA) guidance document on the use of electronic informed consent provides recommendations on the use of electronic systems and processes that may employ multiple electronic media to obtain informed consent for human subject research regulated by Health and Human Services (HHS) and clinical investigations of medical products, including human drug and biological products, medical devices regulated by the FDA, and combinations thereof.
For the purposes of the FDA guidance, eIC 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.
The guidance document was released to ensure the following:
- Continuing protection of the rights, safety and welfare of human subjects
- Facilitation of the subject's comprehension of the information presented during the eIC process
- That appropriate documentation of consent is obtained when electronic systems and processes that may employ multiple electronic media are used to obtain informed consent
- The quality and integrity of eIC data included in FDA applications and made available to FDA during inspections
To maintain the integrity of the informed consent form and its usage to educate potential participants about the research, a balance must satisfy the principles of consent:
- Autonomy (given voluntarily)
- Self-determination (given by an individual who has capacity)
- Affirmation of human rights and respect for human dignity (given by an individual who has been fully informed about the benefits, risks, issues and conflicts of interests)
The informed consent process must have the following elements:
- Use of understandable terms and detailed information
- Sufficient time to make a well-informed decision regarding participation
- Ability to ask questions and make comments to the principal investigator or designate
- Minimize undue influence or coercion - it must be clear to the subject that the receipt of care and health services will not change if they choose not to participate
- The Informed Consent Form must not use exculpatory language (it must not be written to waive rights of the patients or release the researchers and sponsors from liability due to negligence)
- It must be clear to the subject that participation is voluntary and they are entitled to withdraw without penalty or loss of benefit
Benefits of eIC
When used appropriately, eIC can increase participants' access to information, time to review and comprehension, while addressing conflicts of interest by having transparent information of the researcher/medical practitioner's business relationship to study sponsors and other funders.
Every eIC should be easy to navigate, allowing the user to proceed forward or backward within the system and to stop and continue later. Hyperlinks may be provided where helpful. The eIC may also incorporate electronic strategies to encourage subjects to access all the consent material before documenting their consent. The eIC must adhere to all these requirements:
- The information must be in language understandable to the potential subject or the subject's Legally Authorized Representative (LAR)
- Understandable means that the information presented to subjects is in a language and at a level the subject can comprehend
- To ensure that the eIC is presented appropriately and that subjects will have enough time to dedicate to the eIC process, the subjects should be informed of approximately how long the process will take and what information will be presented to them.
The eIC may use electronic signatures that comply with all applicable requirements. The electronic system must also capture and record the date that the subject or subject's LAR provides consent. The regulations permit a wide variety of methods to create electronic signatures, including using computer-readable ID cards, biometrics, digital signatures and user name and password combinations. FDA does not mandate or specify methods for electronic signatures, including any biometric method upon which an electronic signature may be based, as long as the system being used is secure and auditable.
All eIC documents, information and processes must be approved by an independent research ethics committee.
It is important to note that eIC may not be suitable for all subjects and that 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. Therefore, subjects should have the option to use paper-based or electronic informed consent methods completely or partially throughout the informed consent process. Subjects may need to be trained or assisted with the technology.
Employing eIC can significantly improve the subject's experience in the process. As clinical researchers, we must have a firm understanding of the regulations before deciding to implement an eIC process (or to supplement or replace paper-based process). Remember that each study and subject population is unique, so consider that when looking at how to use eIC. Lastly, consider the use of more than one technology to convey your message, to ensure inclusivity.