eConsent and IRB Alignment
Informed consent in clinical trials has often been mistakenly understood as a mere signature on a piece of paper. However, the reality is far more complex, as ethical committees, working in concert with regulatory bodies like institutional review boards (IRBs), emphasize an ongoing and comprehensive process that ensures participants fully comprehend the journey they are embarking upon.
Keep reading to learn more about the pivotal role of electronic consent platforms in revolutionizing the consent process and how eConsent benefits trials, aligns with IRB ethical commitments in the US and Canada, offers guidance on preparing a robust IRB submission for approval, and hints at the future influence of large language models on informed consent.
Informed consent, a multifaceted journey
Ethical committees, the custodians of research participants’ rights, privacy, and welfare, scrutinize informed consent processes. Their objective? To ensure patients possess a clear understanding of the advantages and risks associated with participating in a clinical trial. In the United States, these FDA-mandated guardians are known as IRBs.
The FDA’s definition for informed consent is composed of three crucial elements:
- Providing Comprehensive Information: Ensuring that patients receive all the necessary information to make an informed decision.
- Interactive Understanding: Allowing opportunities for patients to test their comprehension and ask questions.
- Continual Updates: Providing ongoing updates about the impacts of participation on their safety and well-being.
In essence, informed consent must be holistic, interactive, and continuous.
eConsent: Beyond Digital Documentation
The FDA endorses eConsent for its potential to enhance patient engagement with trial materials and to keep them informed throughout the process. When thoughtfully designed, eConsent offers participants alternative ways to access and digest informed consent material outside a clinical setting. It introduces innovative methods for assessing knowledge and addressing queries, all while providing updated information in a structured manner that appeases IRBs without perplexing participants.
The Benefits of Choosing eConsent
The advantages of eConsent go beyond saving trees and time, they include vastly improved recruitment and retention efforts and streamlined data flow: eConsent platforms extend beyond the consent process, often encompassing recruitment, screening, enrolment, and trial onboarding tools. Unlike traditional paper forms, electronic consent eliminates the need for researchers to painstakingly re-enter data into the trial database.
Large Language Models and eConsent
Large language models (LLMs) bring exciting possibilities to simplify the interactive aspects of informed consent for patients while streamlining workflows for investigators and IRBs. LLM-generated video content, once human-approved, can engage participants in the informed consent process. Incorporating LLM-powered chatbots in eConsent could provide real-time answers to patient queries, emulating the onsite experience at home, reducing patient travel, and site burden.
While the research community may not be fully prepared to integrate patient-facing tools powered by LLMs into the consent process, these models hold immediate potential to assist trial staff and IRBs by generating content for human review and simplifying processes.
Incorporating eConsent in Your IRB Submission
For those contemplating eConsent in their clinical trials, a critical step is to submit their plans to the IRB for approval. A well-documented submission detailing how eConsent supports participants’ decision-making processes and their journey throughout the trial is essential. Developing your eConsent strategy before submission can reduce the likelihood of IRB-requested modifications, ultimately saving valuable time and resources.
IRB members must engage with the same materials as participants to extend their impact. This entails providing access to all electronic materials used in the eConsent tool, not just the content. They will assess interface usability, material accuracy, suitability for participants, and the validity of hyperlinked information.
You should consider the following elements when preparing your submission include:
- Consent Workflow: Specify whether the consent discussion will be face-to-face, remote, or a combination. Non-face-to-face methods must effectively serve the goals of informed consent.
- Patient Comprehension Assessment: Clearly elucidate how researchers will ensure patients meet the criteria of informed consent. This may involve explaining the study, assessing understanding through methods like popup quizzes, and answering questions.
- eSignature Process: Electronic signatures (eSignatures) are integral to eConsent. Requirements for eSignatures can vary by country, impacting global eConsent adoption. Consider how the electronic signature will be created and proven legitimate.
- Special Circumstances: Address any unique needs related to eConsent for your trial, such as obtaining assent and parental permissions for minors, addressing translation for non-English speakers, and accommodating participants without access to the necessary technology.
ECLEVAR – CRO services that embrace eConsent for US and Canada Clinical Trials
eConsent holds immense potential for making informed consent more accessible for trial participants and more manageable for sponsors and investigators. It seamlessly aligns with IRB efforts to ensure participants have a profound understanding of their involvement in a trial.
If you’re considering eConsent for your clinical trial, it’s crucial to evaluate how its unique elements, including eSignatures and content delivery, align with IRB requirements. The best time to embark on this journey is before submitting your application to your IRB. Explore the possibilities of a modern clinical trial, contact us to learn more about the introduction of eConsent in your study.