eConsent Ethics and Regulations in Clinical Trials
The US Food and Drug Administration (FDA) defines eConsent as “using electronic systems and processes that may employ multiple electronic media, including text, graphics, audio, video, podcasts, passive and interactive Web sites, biological recognition devices, and card readers, to convey information related to the study and to obtain and document informed consent”.
Sponsors and researchers are increasingly motivated to incorporate this into clinical trials. eConsent provides potential patients with the information needed to make a decision on participation via tablet, smartphones, and digital multimedia.
This serves as a powerful tool when combined with video calls. For example, patients are able to ask questions to researchers as they read the document. Thus, they gain a sense of autonomy and control as they proceed at their own pace.
This method is scalable and reduces time pressure on all individuals involved in the trial. Also, it allows for a diverse, interactive, integrated presentation of information.
One of the key ethical aims of the consent process is autonomy. Digitalization enhances this. For example, patients can explore the trial in greater detail and view more information. It can provide digital support for issues, as well as a critical means by which ethicists and stakeholders bridge ethical ideals with on-the-ground realities.
Once signed, eConsent offers the benefit of dynamic consent to patients. An individual consents at one moment in time, in a certain context, and under a certain understanding. But, situations can easily change. eConsent allows participants to withdraw consent after the initial signing. This is not ideal for researchers but is an ethical benefit of this technology.
Informed consent ethics and regulations differ between countries or states. Thus, clinical trials need to ensure that they get approval for their consent forms from the appropriate ethics authority.
eConsent For Clinical Trials Involving Children
In cases with children, parental consent is necessary. This goes for children under the age of 18. Experts believe that involving children in healthcare decision making is important. It is a crucial aspect in digital informed consent, with children being involved as much as their understanding permits.
Essentially, this is so they can express their feelings and needs. They are seen as equal partners in the decision making. This is called “child assent”.
It is rare for adolescents to not be a decision-maker in the face of such a choice. Exceptions to this are usually down to other factors that prevent them from making informed decisions.
If the child is over 16 and consents to investigation or treatment they usually cannot be overruled. Although this is dependent on whether the doctor feels they are mature enough to make such a decision.
eConsent forms targeting children are only just being developed. However, novel approaches to this include providing a framework to deliver components of the consent form within simple, digestible modules.
eConsent is still relatively new to the clinical trial market but appears to be paving the way. It is likely to enhance patient understanding. Therefore, it will increase retention – particularly with novel techniques to educate children.
Considering eConsent for your clinical trial? Reach out to our team to learn how you can effectively collect patient consent remotely