ICF guidelines

The 'Guidelines for tailoring the informed consent process in clinical studies' are the main practical output of the EU H2020‑funded i‑CONSENT project, which focuses on improving how information is provided to people considering participation in clinical research. The document aims to make informed consent more understandable, inclusive and adapted to participants’ needs and circumstances, while remaining aligned with existing ethical and regulatory frameworks, including the EU Clinical Trials Regulation.

Scope and Content:

• Focuses on informed consent for clinical studies with human participants; consent in routine clinical practice is out of scope.
• Treats consent as an ongoing, bidirectional communication process from first contact to study completion.
• Promotes a participant‑centred, inclusive approach that considers gender, age, socio‑cultural and economic factors, health literacy and layered communication to support autonomous decisions.

Consent as a process 

• Re‑frames consent as a continuous ethical and communication process rather than a legal form.
• Outlines key phases: first contact, information provision, discussion, decision making, intervention and follow‑up, and study completion.
• Introduces the i‑CONSENT acronym (Information, Co‑creation, Ongoing process, New technologies, Self‑determination, Empowerment, Non‑standard inclusive and tailored, Trusted) and provides guidance on co‑design and tailoring for diverse groups, including minors, pregnant and breastfeeding women, culturally diverse and low‑income populations.

Checklist – step‑by‑step guide 

• Provides a concise checklist to design, document and review all stages of the consent process.
• Supports regulatory, funding and ethics committee requirements while keeping participant understanding, inclusiveness and autonomy central.

Fact sheets and tools 

• Fourteen fact sheets cover practical topics such as health literacy, presenting study information, advertising, consent discussions, investigator–participant relationship, assessing comprehension, decision aids, re‑consent, healthy volunteers, biological samples and data, placebo, and consent in COVID‑19 and other emergency situations.
• Six tools provide hands‑on support on communication skills, obtaining participant feedback, thank‑you letters, lay summaries of results, integrating participant perspectives and addressing fake news and source reliability.

List of scientific deliverables and publications 

• Summarises public project deliverables and publications on guidelines and standards, gender and age issues, ethical and legal analyses, socio‑cultural and behavioural aspects and patient perspectives, with links for further detail.