Published March 25, 2021 | Version v1
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Guidelines for Tailoring the Informed Consent Process in Clinical Studies

Creators

  • 1. Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
  • 2. Universidad Católica de Valencia (UCV)
  • 3. UNESCO Chair in Bioethics and Human Rights
  • 4. Libera Università Maria Ss. Assunta (LUMSA)
  • 5. GSK
  • 6. AND Consulting Group
  • 7. Meningitis Research Foundation (MRF)
  • 8. Ospedale Pediatrico Bambino Gesù (OPBG)

Description

These guidelines have been designed to provide information and evidence to assist with the development, or review of the consent process for use in clinical studies with human participants. These guidelines do not deal with 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 a European Union H2020 funded program that aims to improve the information that individuals receive when deciding whether or not to take part in clinical studies.

Files

Guidelines_for_tailoring_the_informed_consent_process_in_clinical_studies.pdf

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Additional details

Funding

I-CONSENT – Improving the guidelines for Informed Consent, including vulnerable populations, under a gender perspective 741856
European Commission