Camila Matheny
You asked, we answered: Is electronic ICF revision easier than paper?
One of the most common questions we’re asked about digital informed consent/eConsent is: What does the ICF amendment or revision process look like within a digital platform and is this harder or easier than traditional paper based approaches?
You asked, we answered: How long to plan for your first eConsent implementation
Implementing digital informed consent (or eConsent) in clinical trials can be challenging and complex, but it doesn’t have to be! One of the main reasons for this difficulty is the traditional mindset and habits of conducting clinical trials. Clinical trials have long relied on paper-based informed consent process, and making the switch to a digital solution requires a significant shift in mindset and approach. Additionally, different stakeholders, such as study sponsors, ethics committees, regulators, sites and patients, may have different expectations, perceptions and requirements for eConsent implementation, adding to the complexity of the process. Therefore, careful planning, communication, and a thoughtful execution are essential for the success of an eConsent implementation and adoption in studies.
You asked, we answered: How to expedite the eICF ethics review process
Obtaining approval of an electronic informed consent doesn’t have to be a complex and time-consuming process. While the review process involves multiple stakeholders, including sites, sponsors, Ethics Committees (ECs), Institutional Review Boards (IRBs), and Health Authorities (HAs). Researchers and study teams are constantly looking for ways to streamline their processes and improve efficiency.
While the paper consent review process has remained the same, we have seenmany layers of improvements and efficiencies around electronic informed consent forms (eICFs). eICFs have emerged as a solution to help participant understanding and engagement, trials accessibility, and improve data quality.
However many researchers still are hesitant to adopt due to concerns about the submission process, timelines, and regulatory compliance. In this blog, we will discuss how to overcome these obstacles and streamline the ethics review process by adopting eICFs.