Information sheet and informed consent in clinical research

Underestimated documents, major stakes

The information sheet and the informed consent form (ICF — Informed Consent Form) are among the documents most frequently sent back for revision by ethics committees (CPP). Yet they are often written last, in a rush, as an administrative formality.

These documents are not regulatory constraints: they are the operational expression of respect for the participant's autonomy. An ethics committee (CPP) that identifies overly technical language, incomplete information, or wording liable to mislead the patient will systematically send the file back for revision — regardless of the scientific quality of the protocol.

Information sheet and consent form: two distinct documents

These two documents serve different functions and must be clearly distinguished.

The information sheet explains the study to the participant: why it is being conducted, what it involves for them, and what their rights are. It is provided before any decision is made.

The consent form records the participant's agreement after they have had time to read the information sheet, ask questions, and reflect. It is signed by the participant (or their legal representative) and by the investigator.

The participant must be able to keep the information sheet after signing the form. Merging the two into a single document without a legible separation is a ground for revision by the CPP.

Structure of a compliant information sheet

1. Project identification

Study title, sponsor name, name of the principal investigator, version, and date of the document. The version and date are essential for traceability — an ethics committee (CPP) that receives a document without version control cannot verify compliance with the submitted protocol.

2. Presentation of the study and rationale

Explain in accessible language why the study is being carried out, what the current state of knowledge is, and what the study seeks to contribute. Avoid unexplained medical jargon.

Readability test: a patient with a high-school level of education should be able to understand the document without outside help.

3. Course of participation

Describe chronologically what the participant will be required to do: visits, sample collections, questionnaires, examinations. Specify the total duration of participation and the duration of each visit. This section must be perfectly consistent with the protocol — any discrepancy will be flagged by the CPP.

4. Benefits and risks

The expected direct benefits for the participant (if any) and the collective benefits. The risks and constraints associated with participation, even minimal ones. It is prohibited to downplay risks or to omit constraints in order to facilitate recruitment.

5. Voluntary nature and right to withdraw

Participation is voluntary. The participant may withdraw at any time without this affecting their care. This statement is mandatory and must be worded in an explicit and unambiguous manner.

6. Personal data and confidentiality

Explain how the data will be collected, stored, pseudonymized, and who will have access to it. Explicitly mention the right of access, rectification, and objection in accordance with the GDPR. Specify the data retention period.

7. Insurance and compensation

Mention the existence of sponsor insurance covering any harm related to participation (mandatory under RIPH 1 and 2).

8. Contacts

Contact details of the investigator or the referring physician for any questions during and after the study.

Mistakes that trigger a CPP rejection

Mistake	Ground for revision
Overly technical language	The CPP assesses comprehensibility by the patient — not by a physician
Discrepancy with the protocol (visits, volumes, duration)	Any documentary inconsistency is a ground for a request for clarification
Overstated benefits or downplayed risks	Wording liable to unduly influence the participant's decision
Missing version and date	Document not traceable within the submission process
Information sheet and form merged without legible separation	The participant must be able to keep the information sheet after signing

Adaptations according to the RIPH category

Category	Consent format	Time of collection
RIPH 1	Signed written consent — mandatory	Before any inclusion, after a sufficient reflection period
RIPH 2	Express consent — formalized in writing in practice	Before any inclusion
RIPH 3	Non-objection after information — no mandatory signed form	After the information sheet has been provided with a reasonable delay

In practice

The information sheet and the consent form are the documents that move the protocol from the methodological sphere to the participant's sphere. Writing them at the start of the project, in parallel with the protocol, avoids documentary debt and the CPP rejections that delay study setup by several weeks.