Guidelines for Tailoring the Informed Consent Process in Clinical Studies

What is this about?

These guidelines are designed to assist in the development or revision of the consent process for use in clinical trials involving human participants. These guidelines do not address issues related to informed consent in clinical practice.

The guidelines have been developed by the i-CONSENT consortium. i-CONSENT (H2020, Grant Agreement number 741856) is an EU-funded H2020 project that aims to improve the information that individuals receive when deciding whether or not to participate in clinical trials.

For whom is this important?

Clinical researchersAll stakeholders in researchClinical ethics consultantsEthics committee membersmedical researchersResearch subjectssponsorsPharma IndustryRegulators

Other information

Research Area

LS 07.11 - Medical ethics