Respect - Article 10

Article 10

Changes to the process of seeking informed consent must not compromise understanding for potential participants. This includes ensuring that research participants do not mistake research for treatment (‘therapeutic misconception’) when healthcare staff rather than researchers collect consent during crises.

Research has shown that the process of obtaining informed consent changed considerably during the COVID-19 pandemic. In particular remote consent and the involvement of legally authorized representatives increased significantly. In addition, healthcare staff often obtained consent rather than researchers. Such changes can have an impact on understanding and when understanding is compromised, the consent process is undermined. It is crucial that measures are taken to ensure that procedural changes do not impact negatively on the consent process.

Relevant research:

Informed consent: Old and new challenges in the context of the COVID-19 pandemic

Key ethical issues encountered during COVID-19 research