03 april 2023 – 20:55
For the first time, patients can give digital consent to participate in research
For the first time, participants in drug research can give digital approval for their participation. This will be done in the first study that will take place in all Dutch general practices, coordinated by researchers from Maastricht UMC +. This study (PLATFORM-COVID trial) investigates multiple drugs against COVID-19
Giving digital approval for participation in research – also known as eConsent – has been possible since mid-2022 due to new legislation. But for the first time it is now actually being used in a study, after approval from the Medical Ethics Committee (METC) of Maastricht UMC +. The METC is an independent committee that tests whether medical research involving humans meets all the conditions.
Why eConsent?
Traditionally, participants in medical-scientific research have to give their consent by means of a paper form with a ‘wet’ signature. But if this form has to be sent by post, it will cause a delay. This makes national research in acutely ill patients difficult. Suppose someone visits the doctor with a serious illness. In this case, GP and patient will not choose to treat that disease within a study, because it will then take several days before the treatment can start. With the digital agreement, also called eConsent, this delay has been considerably reduced.
PLATFORM-COVID
Likewise with COVID-19. If a patient with complaints visits a general practitioner, prompt treatment with medication is desirable. At the same time, research into medicines against this relatively new condition is very important. It was therefore obvious to apply eConsent within the PLATFORM-COVID study of a number of these medicines. Now, the patient will be contacted via video calls with the Maastricht researchers for an explanation for a maximum of 24 hours after the GP visit. During this conversation, the patient can give consent via a digital system. The researchers then ensure that the patient receives the correct medicine at home the next day.
First nationwide study
All Dutch general practitioners can register patients for the PLATFORM-COVID study from May. This makes it the first Dutch study that takes place in all general practices, because it is carried out under the flag of the Consortium Research General Practice takes place, a national initiative to enable large-scale research within general practice in the Netherlands.
Suitable, reliable and safe
The technology behind eConsent must be reliable, secure and appropriate for the research. The researchers of the PLATFORM-COVID trial worked together with the Clinical Trial Center Maastricht (CTCM) and Your Research. Your Research’s technology plays an important role in this research, as it supports the entire research process for patient interactions via an app. 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.
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The PLATFORM-COVID study is a collaboration between Maastricht University, UMC Utrecht and Amsterdam UMC. The research takes place under the banner of the Consortium Research General Practicea national initiative to enable large-scale research within general practice in the Netherlands.
It Clinical Trial Center Maastricht (CTCM) is the trial office of Maastricht UMC+ and knowledge center for human-related research. CTCM supports researchers in the design, implementation and conclusion of research, so that the research is carried out in accordance with the applicable laws and regulations and the quality is guaranteed. In addition, CTCM offers various clinical trial services and personnel support.
Your Research is a company that provides technological solutions to make the preparation and conduct of clinical research more efficient, improve interaction with and involvement of participants with the aim of collecting high-quality data to improve healthcare. The company was founded by researchers and develops in close consultation with researchers.
Maastricht UMC+
The Maastricht University Medical Center+ distinguishes itself nationally and internationally through its focus on prevention. So not only health recovery, but also health maintenance and health promotion. In addition to top clinical and top referral patient care, core tasks are scientific research and education/training. Maastricht UMC+ is characterized by its multidisciplinary and problem-driven approach. The Maastricht university hospital has approximately 7500 employees and 5000 students. Maastricht UMC+ is affiliated with the NFU, the Dutch Federation of University Medical Centers (see also: www.nfu.nl). More information on www.mumc.nl, www.mumc.tv, www.brightlands.com, www.maastrichtuniversity.nl
Health Foundation Limburg is the foundation that raises funds for scientific research at Maastricht UMC+: www.hfl.nl
Source: Maastricht UMC+
Editorial Medicalfacts/ Janine Budding
I studied physiotherapy and Health Care business administration. I am also a registered independent client support worker and informal care broker. I have a lot of experience in various positions in healthcare, the social domain and the medical, pharmaceutical industry, nationally and internationally. And have broad medical knowledge of most healthcare specialties. And of the care laws from which the care is regulated and financed. Every year I attend most of the leading medical conferences in Europe and America to keep my knowledge up-to-date and to keep up with the latest developments and innovations. Currently I am doing a Masters in Applied Psychology.
My posts on this blog do not reflect the strategy, policy or direction of any employer, nor are they work by or for any client or employer.
