eConsent Clinical Trials: How eConsent Is Used For Informed Consent

What Is eConsent?  

eConsent, or electronic informed consent, is a process of obtaining informed consent from potential participants in a clinical trial using electronic systems and processes that employ multiple electronic media, including text, graphics, audio or other interactive digital tools to convey information related to the study. The eConsent process involves providing potential participants with the necessary information about the clinical trial, including the risks and benefits, and obtaining their informed consent in a digital format.

eConsent can offer several benefits over traditional paper-based consent forms, such as increased efficiency and convenience for both the participant and the research team. It can also facilitate the informed consent process by providing interactive tools and multimedia materials that can enhance the understanding of potential participants about the study.

However, the eConsent process should be designed to ensure that potential participants have access to all the information necessary to make an informed decision about participating in the study. It should also be easy to use and accessible to all potential participants, regardless of their technological literacy.

The Role of eConsent In Decentralized Clinical Trials

eConsent plays a significant role in decentralized clinical trials (DCTs) by providing a convenient and efficient method of obtaining informed consent from participants who are not physically present at a trial site. In DCTs, the use of digital technologies allows participants to complete the informed consent process remotely, such as from their home or another location, using online tools.

The use of eConsent in DCTs can improve participant recruitment, retention, and engagement, as it allows for greater flexibility and convenience. Participants can review the trial information at their own pace and in their preferred language, and have the ability to ask questions and seek clarification through the tool.

eConsent can also facilitate the use of remote monitoring technologies, such as wearables or mobile health apps, as it allows for the collection of consent and data in a seamless, digital process.

However, it is important to ensure that the eConsent process in DCTs meets the same ethical and legal standards as traditional informed consent methods, and that it effectively communicates the risks and benefits of the trial to participants. Additionally, eConsent in DCTs may require additional considerations, such as ensuring the security and privacy of participant data, and providing support for participants who may require additional assistance with the digital tools.

The Process of Using an eConsent Platform for Clinical Trial Informed Consent

The process of using eConsent platforms for clinical trial informed consent typically involves the following steps:

Selection of an eConsent Platform

The research team selects an eConsent platform that meets the study’s needs, such as the ability to create interactive multimedia content, support multiple languages, and comply with relevant regulatory requirements.

Development of the eConsent Content

The research team creates the eConsent content, including the trial information, risks and benefits, and the informed consent form. The content is typically designed to be interactive and engaging, using multimedia formats such as videos, graphics, and animations to enhance participant understanding.

Participant Enrollment

Potential participants are identified and invited to participate in the study. The eConsent process is provided to them through the selected eConsent platform, which may include a link to a secure website or a mobile application.

Completion of the eConsent Process

Participants are guided through the eConsent process, which typically involves reviewing the trial information and completing an electronic informed consent form. Participants can ask questions or seek clarification through digital communication channels.

Verification of Participant Identity

The eConsent platform may include features to verify participant identity, such as authentication through a secure login or Multifactor Authentication.

Secure Storage of eConsent Documents

The eConsent documents, including the electronic informed consent form, are securely stored according to regulatory requirements.

The process of using eConsent platforms for clinical trial informed consent aims to improve the efficiency and effectiveness of the informed consent process while maintaining the ethical and regulatory requirements for informed consent. The eConsent process should be designed to ensure that participants have access to all the necessary information and are able to make an informed decision about participating in the study.

eConsent Benefits for Sponsors 

eConsent can be helpful to clinical trial sponsors in several ways:

• Improved Efficiency: The use of eConsent can streamline the informed consent process, reducing the time and resources needed to obtain consent from potential participants. This can improve the overall efficiency of the clinical trial, enabling sponsors to complete the trial faster and with fewer resources.
• Increased Recruitment: eConsent can make the informed consent process more convenient and accessible for potential participants, which can lead to increased recruitment and retention rates. This can be particularly helpful in recruiting a more diverse pool of participants who may not be able to easily travel to a trial site.
• Enhanced Participant Engagement: eConsent can provide an engaging and interactive experience for potential participants, which can improve their understanding of the trial and increase their engagement in the study.
• Improved Data Quality: The use of eConsent can help ensure that all participants receive the same information and that their consent is properly documented, reducing the risk of errors or inconsistencies in the data collected.

The use of eConsent can help clinical trial sponsors to improve the efficiency and effectiveness of their trials, while ensuring that they are meeting the necessary ethical and regulatory requirements for informed consent.

Regulatory Requirements for Electronic Informed Consent

The U.S. Food and Drug Administration (FDA) has provided guidance for electronic informed consent (eConsent) in clinical trials which is titled “Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers” that includes the following requirements:

Ensuring the eConsent process is voluntary

The eConsent process should be designed to ensure that participants can make an informed decision about whether to participate in the study. This means providing clear and understandable information about the study, its risks and benefits, and the informed consent process.

Obtaining informed consent: The eConsent process should provide participants with all the information they need to make an informed decision about participating in the study. This includes information about the study’s purpose, procedures, risks and benefits, and other relevant details.

Protecting participant privacy: The eConsent process should include measures to protect participant privacy and confidentiality, such as the use of secure systems for collecting and storing participant data.

Ensuring security of electronic systems: The eConsent process should be designed to ensure the security of electronic systems, including measures to prevent unauthorized access or alteration of participant data.

Ensuring documentation of eConsent: The eConsent process should include documentation of the participant’s informed consent, which can be done through electronic signatures or other methods that comply with relevant regulations.

Providing access to eConsent documents: Participants should be provided with access to the eConsent documents, such as through a secure online portal, and should have the ability to download or print these documents if they wish.

This guidance emphasizes the importance of ensuring that eConsent processes meet the same ethical and regulatory requirements as traditional informed consent methods, and provides specific guidance for meeting these requirements in the context of electronic systems.

YPrime’s eConsent Clinical Trial Solutions

YPrime provides electronic data capture (EDC) and clinical trial management software solutions, including an eConsent platform. The YPrime eConsent platform is designed to simplify the informed consent process for clinical trial participants while meeting regulatory requirements for informed consent.

The YPrime eConsent platform includes features such as:

• Customizable Content
• Interactive Functionality
• Secure Data Storage
• Audit Trails
• Multi-language Support
• Compatibility with Mobile Devices

The YPrime eConsent platform is designed to improve the efficiency and effectiveness of the informed consent process, while ensuring compliance with regulatory requirements. By providing an engaging and interactive experience for participants, the platform can help increase recruitment and retention rates, and improve the quality of data collected in clinical trials