Preparing accessible and understandable clinical research participant information leaflets and consent forms: a set of guidelines from an expert consensus conference.

ABSTRACT:

Background

In line with Good Clinical Practice and the Declaration of Helsinki, it is the investigator's responsibility to ensure that research participants are sufficiently informed, to enable the provision of informed consent. The Participant Information Leaflet/Informed Consent Form is key to facilitating this communication process. Although studies have indicated that clinical research Participant Information Leaflets/Informed Consent Forms are not optimal in terms of accessibility, there is little or no specific guidance available. The aim of this research was to propose and agree a set of guidelines for academic researchers and sponsors for preparing accessible and understandable Participant Information Leaflets/Informed Consent Forms.

Methods

A literature review ident

SUBMITTER: Coleman E 

PROVIDER: S-EPMC8130271 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature