December 22nd 2022
Published in Frontiers in Medicine: the COVID-19 pandemic hampered the sharing of information with and securing of consent from clinical study participants, but did not impact GDPR compliance

Published in Frontiers in Medicine: the COVID-19 pandemic hampered the sharing of information with and securing of consent from clinical study participants, but did not impact GDPR compliance

CARE partner KU Leuven (KUL, Belgium) conducted an online survey followed by semistructured interviews to gain insights into compliance with the General Data Protection Regulation (GDPR) for clinical studies and general aspects related to obtaining electronic Informed Consent (eIC) in Europe and the UK, before and during the pandemic. The survey targeted data protection officers or legal experts working in the pharmaceutical industry, academia, and academic biobanks involved in clinical research, investigators (physicians), and members of ethics committees.

The first part of the study empirically elucidated numerous key legal and ethical issues related to GDPR compliance in the context of (cross-border) clinical research (Lalova-Spinks et al.). First, the lack of legal harmonization remains the biggest challenge in the field, and that it is present not only at the level of the interplay of key EU legislative acts and national implementation of the GDPR, but also when it comes to interpretation at local, regional and institutional levels. Secondly, although the majority of respondents were opposed to Ethics Committee having a role in the determination of core choices that are under the responsibility of the controller, experts seemed to agree that it would be useful to clarify their role in data protection in an official manner. Finally, the pandemic did not bring additional legal challenges. Indeed, although practical challenges were high due to the globally enacted crisis measures, the key problematic issues on (cross-border) health research, interpretations of the legal texts and compliance strategies remained largely the same.

The second part of the study aimed to investigate stakeholders’ experiences with alternative consenting methods as well as their views on any regulatory or legal guidelines for eIC implementation in clinical research (De Sutter et al., 2022). The COVID-19 pandemic has impacted the clinical research activity in many countries, posing multiple challenges to ensure study continuation while minimizing the risk of infection for the participants as well as the research team. One of them was informing research participants about study-related information and obtaining their Informed Consent. The survey indicates that all stakeholder groups support the use of eIC during the COVID-19 pandemic and beyond. eIC indeed offers the opportunity to convey information interactively, by making use of multimedia or by offering information in a layered approach. Nevertheless, stakeholders had little practical experience with eIC and reported some challenges that hinder its deployement.
In addition, there is a varying understanding of the term “eIC” as well as limited European or country-specific support, from a regulatory and legal point of view, to facilitate implementation. Finally, the survey results showed that the COVID-19 pandemic resulted in some additional challenges to convey study-related information to participants and to obtain their consent.

These exploratory studies provide a snapshot into the real-life practices and beliefs in relation to the application of GDPR in clinical research as well as eIC. They underline a need for legal harmonization and a common multinational database that would support a GDPR and data protection compliant effort into global research. In addition, as alternative Informed Consent practices may be incorporated into common clinical practices, in the future a multi-stakeholder, multi-national guidance could contribute to a more harmonized eIC approach in clinical research.

To learn more, click here:
Challenges related to data protection in clinical research before and during the COVID-19 pandemic: an exploratory study.

Rethinking informed consent in the time of COVID-19: an exploratory survey.