Het PLATFORM-COVID trial research, in which several COVID-19 medicines are being investigated, is coordinated by Maastricht UMC+. For a national study, the possibility of recruiting participants via digital consent offers many advantages. The decision to make use of the option whereby patients give digital consent for participation has been reviewed by the Medical Ethics Committee (METC) of Maastricht UMC+.
Digital consent speeds up research
Normally, patients who are invited for medical-scientific research must physically sign a form. Processing those forms, sometimes by mail, can take several days. For patients who need immediate treatment, this often means that the GP does not choose to treat the patient in question within a study. Because patients can now grant consent digitally, delays are no longer an issue.
Digital consent is also an outcome for research into COVID-19 medicines. This is pre-eminently a disease in which the treatment of patients must be started quickly. In addition, research into medication for COVID-19 is still very important. After all, it is still a relatively new and serious disease.
PLATFORM-COVID study
That is one of the main reasons why it was decided within the PLATFORM-COVID study to opt for eConsent for a number of medicines studies. Patients who are eligible for one of these studies are contacted by the Maastricht researchers via video calls no more than 24 hours after their visit to the GP. During that conversation, they will receive an explanation about the research and, if they want to participate, they can grant permission digitally. The researchers then ensure that the patient receives the correct medicine at home the next day.
GPs can start registering patients for the PLATFORM-COVID study from May. Because the research is being carried out under the banner of the General Practice Research Consortium, this is the first Dutch study to be conducted in all general practices.
App for patient interaction
To ensure the safety and reliability of the technology behind eConsent, the researchers collaborated with the Clinical Trial Center Maastricht (CTCM) and Your Research. For interaction with the patients participating in the study, support has been chosen through an app that has been developed with Your Research’s technology.
This app offers patient information, eConsent, video call appointments and data collection. This enables the research team to easily coordinate the process from a very user-friendly environment and to easily follow the research process.
Electronic Consent
The possibility of digitally granting permission for participation in Medical Scientific Research is part of the amended WMO introduced in July 2022. This amendment stipulates that written consent can be given not only by paper means, but also by electronic means, subject to certain conditions.
The most important conditions are that electronic consent is appropriate for the research and that the process for granting consent electronically is sufficiently reliable and confidential. The procedure for granting electronic consent should be described in the research protocol.