Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies.

ABSTRACT:

Background

The H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders.

Methods

An adaptation of the RAND/UCLA Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting.

Results

Fifty-three recommendations were evaluated. A

SUBMITTER: Fons-Martinez J 

PROVIDER: S-EPMC8513381 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature