Commentary Contributed by Mia Allen, Product Manager, Cambridge Cognition 

May 3, 2024 | Electronic consent, or eConsent, has emerged as a cornerstone in the decentralized clinical trials (DCTs) landscape. Central to this is the Food and Drug Administration’s (FDA) resounding endorsement of electronic methodologies for obtaining informed consent from clinical trial participants. This backing underscores the acceptability and potential advantages of leveraging electronic processes in clinical research, promising more streamlined approaches, enhancing participant comprehension of study protocols, and enabling broader participation and inclusivity among diverse populations.  

eConsent

Informed consent, as defined by the FDA, is the proof of providing a prospective research participant or their authorized representative with comprehensive information necessary for making an informed decision about joining a clinical investigation. This process includes ensuring the individual understands the provided information, offering ample opportunity for questions, providing appropriate time for consideration, and obtaining their voluntary agreement to participate. Additionally, it involves providing relevant information as an investigation progresses. 

eConsent uses different digital functionalities to simplify obtaining informed consent within clinical trials. These digital tools encompass various features, including tiered consent structures, comprehensive glossaries, interactive quizzes, video conferencing, and detailed reports. eConsent aims to ensure that trial participants thoroughly comprehend the specifics of a clinical trial, its procedures, potential risks, and benefits, empowering them to make well-informed choices.  

It should be acknowledged that there is no universally applicable eConsent model. Each clinical study, geographical location, research site, and participant may have unique requirements. The strength of eConsent lies in its flexibility, which allows for tailored customization to meet a wide range of needs.  

Comparison to Traditional Methods

Compared to traditional paper-based consent processes, eConsent offers easier access, efficiency, greater transparency, and standardized information about a study protocol and transforms how the industry supports participants in deciding to join a clinical trial. The advantages of eConsent extend to improving information conveyance through multimedia content, eliminating the need for travel for potential participants or research staff, and ultimately enhancing trial recruitment. This is particularly beneficial for increasing access to clinical trials for participants who live far from a research site, have reduced mobility, or lack reliable transportation. The burden of paperwork is also eliminated. With eConsent, little to no paperwork is required, dramatically reducing site overhead and offering better data security. eConsent solutions also directly connect patients with study staff during the consent process. However, amid its many benefits, specific considerations remain. Chief among these are the challenges of determining an individual’s capacity to consent and ensuring that the decision is truly informed and voluntary. Additionally, questions loom over potential vulnerabilities, including the risk of identity theft and pertinent data confidentiality issues. Careful navigation and safeguards are imperative to address these challenges and maximize eConsent’s potential. 

Regulatory Support 

The FDA’s proactive stance on eConsent has helped pave the way for its growing adoption. The agency’s Guidance on Informed Consent, unveiled in August 2023, endorses using electronic processes within clinical research to obtain informed consent. This directive highlights the multifaceted benefits, notably the capacity to transform the consent process through interactive interfaces, enhancing participant’s understanding and retention of crucial information. Moreover, it states that eConsent streamlines data entry, ensuring timely and accurate documentation within study databases while concurrently broadening the accessibility of clinical trials.  

The FDA offers comprehensive guidance to support these practices and addresses pertinent questions in its document: ‘Guidance for Institutional Review Boards, Investigators, and Sponsors, Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers.’ This resource is a crucial reference point for study sponsors, offering valuable insight and clarification on integrating eConsent.  

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) and the UK Health Research Authority (HRA) have also laid out expectations regarding the informed consent process, highlighting that if the principles of Good Clinical Practice (GCP) are upheld and the rights of participants safeguarded, the use of eConsent is acceptable. 

The European Forum for Good Clinical Practice (EFGCP) is also spearheading an influential eConsent initiative, a collaborative effort uniting multiple stakeholders, including pharmaceutical companies, vendors, academic institutes, patients, clinical trial sites, ethics committees, and health authorities. Several objectives are driving this non-profit endeavor. First, it aims to establish practical guidelines with standardized terminologies for the different facets of eConsent to ensure consistency and clarity across the board.  

The initiative also seeks to establish a global database that offers valuable insights into the acceptance and non-acceptance of various eConsent aspects at the country level, providing a more comprehensive understanding of regional preferences and practices. It also aspires to empower stakeholders, equipping each group with the resources to promote awareness and education within their communities.  

Lastly, a core focus lies on sustainability, laying the foundations for a sustainable maintenance model to ensure the perpetuity of the database and guidelines, thereby fostering continual progress in the realm of eConsent.  

Removing Barriers to eConsent

Integrating eConsent is a strategy for dismantling some of the barriers within DCTs, bringing many advantages to the clinical development landscape. Its emphasis on improving accessibility is helping to ensure that clinical trials become more universally accessible, transcending geographical constraints and temporal limitations. This marks a significant move forward in democratizing medical research, inviting more diverse participation. 

eConsent can bring greater clarity by presenting a consistent overview of a study protocol, eradicating ambiguities, and empowering participants to make informed decisions. A digital framework enhances the efficiency of delivering administrative tasks and can ensure better data accuracy, mitigating errors and aligning with stringent regulatory standards. The interactive features already mentioned also serve to not only amplify engagement but bolster comprehension during the consenting process. Crucially, eConsent’s real-time tracking capability enables the continual monitoring of participants’ understanding and consent, thereby making the research journey more transparent.  

Final Thought

The value of eConsent lies in its ability to streamline approaches, enhance participant comprehension, and foster broader inclusivity among diverse populations. By adopting digital functionalities to simplify the consenting process, eConsent ensures participants grasp the specifics of a trial, with the potential to test just how well they have understood the information provided and empower them to make informed decisions about their participation. Its flexibility, catering to unique study requirements, positions it as a versatile tool which can transform how the industry supports participants before enrolment and for the duration of a clinical trial.  

The integration of eConsent is helping to remove barriers that have long stood as a challenge in clinical research, ensuring accessibility, clarity, efficiency, and real-time transparency. With the FDA’s guidance and initiatives like the EFGCP continuing to drive the development and understanding of best practice approaches to eConsent, the future holds great possibilities for digital enablement of the consenting process, ultimately benefiting patients, research, and the ecosystem of clinical development.  

Mia Allen is Senior Product Manager at www.cambridgecognition.com, overseeing its clinical trial platform solution. She holds a Computer Science MSc from Queen Mary University of London. She can be reached at mia.allen@camcog.com.