Risks and benefits of e-consenting in clinical trials

One of the main benefits of e-consenting is improved efficiency and accuracy of the consent process. With e-consenting, potential participants can easily review the informed consent document and provide their electronic signature, reducing the need for in-person meetings and the potential for errors. E-consenting also allows for real-time tracking of consent forms, ensuring that all participants have provided their consent before enrolling in the trial.

Another benefit of e-consenting is the ability to collect electronic patient reported outcomes (ePRO) data. With ePRO, participants can easily provide real-time data on their symptoms and side effects, allowing for more accurate and timely data collection.

Despite these benefits, there are also potential risks associated with e-consenting. One of the main risks is the potential for misunderstandings or misunderstandings of the informed consent process. In a traditional in-person consent process, the study coordinator can provide explanations and answer any questions the potential participant may have. With e-consenting, the participant may not fully understand the implications of participating in the trial and may not have the opportunity to ask questions.

Another risk of e-consenting is the potential for technical issues. If the electronic consenting system is not functioning properly, it could cause delays in the trial and potentially compromise the validity of the collected data. It is important to have a plan in place to address any technical issues that may arise during the e-consenting process.

In addition, there are also potential privacy concerns with e-consenting. The electronic consent forms may contain sensitive personal information, and it is important to ensure that the appropriate security measures are in place to protect this information.

Overall, e-consenting offers many benefits, including improved efficiency and accuracy of the consent process and the ability to collect ePRO data. However, it is important to carefully evaluate the potential risks and implement appropriate safeguards to ensure the safety and integrity of the clinical trial.