Rethinking informed consent in the time of COVID-19: the digital transformation

The impact of the COVID-19 pandemic on the conduct of clinical trials has been immense.

To promote the safety of the research participants and the research team, alternative methods were recommended, for example by the European Medicines Agency, to inform the participants about the clinical trial and to obtain their consent. Electronic informed consent (eIC), referring to the use of digital media to convey information and to obtain informed consent, is one of the alternative methods that have been implemented during the COVID-19 pandemic. The effect of the pandemic on the conduct of clinical trials has been immense and may result in new insights to improve the informed consent process. Therefore, this study aims to investigate the perspectives of different stakeholders involved in clinical research on various consenting methods such as eIC. In addition, it provides an understanding into stakeholders' views on the legal acceptance of eIC in the countries where they operate.

To this end, an online survey was distributed to relevant stakeholder groups, involved in clinical research, across European Member States and the United Kingdom. These stakeholders include legal teams and data protection officers at research organizations and pharmaceutical companies as well as physician-investigators and ethics committee members. The survey was disseminated via social media and by international organizations such as the European Network of Research Ethics Committees and the Innovative Medicines Initiative: Corona accelerated R&D in Europe. Responses were analyzed descriptively via Microsoft Excel. The online survey was completed by 190 respondents, of whom the majority were physician-investigators. Respondents were active in 25 out of the 27 European Member States and the United Kingdom. Data analysis is currently ongoing. Preliminary results suggest that stakeholders' experiences with eIC is low. Nevertheless, these results indicate that all stakeholder groups support the use of eIC to inform trial participants, including COVID-19 patients, and to obtain their consent, during the COVID-19 pandemic and beyond. In addition, it seems that the legal acceptance of eIC in clinical research varies across European Member States and the United Kingdom.

Authors

Evelien De Sutter (1), Teodora Lalova (1,2), Isabelle Huys (1)

Organisations

Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium (1), Center for IT & IP law (CiTiP), KU Leuven, Leuven, Belgium (2)

Presenting author

Evelien De Sutter, PhD researcher, KU Leuven
evelien.desutter@kuleuven.be
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