Informing a European guidance framework on electronic informed consent in clinical research: a qualitative study.

ABSTRACT:

Background

Electronic informed consent (eIC) may offer various advantages compared to paper-based informed consent. However, the regulatory and legal landscape related to eIC provides a diffuse image. By drawing from the perspectives of key stakeholders in the field, this study aims to inform the creation of a European guidance framework on eIC in clinical research.

Methods

Focus group discussions and semi-structured interviews were conducted with 20 participants from six stakeholder groups. The stakeholder groups included representatives of ethics committees, data infrastructure organizations, patient organizations, and the pharmaceutical industry as well as investigators and regulators. All were involved in or knowledgeable about clinical research and were active in one of

SUBMITTER: De Sutter E 

PROVIDER: S-EPMC9942635 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature