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[Informed consent form for biomedical research: a tutorial for redaction].

Yvette Hénin¹, Bénédicte de Boischevalier, Françoise Reboul-Salze

¹Inserm CIC BT505, Paris, France.

Therapie

|May 19, 2010

Summary

A new tutorial aids researchers in creating compliant informed consent forms for biomedical research participants in France. It addresses legal requirements and participant rights, ensuring ethical research practices.

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Area of Science:

Biomedical research ethics
Clinical trial regulations
Participant informed consent

Context:

Implementation of European Directive 2001/20/EC in France mandates written informed consent for research participants.
Lack of specific guidelines for drafting these essential research documents creates challenges for investigators.
Ensuring participant rights and data quality requires standardized, ethically sound consent forms.

Purpose:

To present a comprehensive tutorial for investigators on creating legally compliant and ethically sound informed consent forms.
To address the absence of clear guidelines for drafting participant information and consent documents in French biomedical research.
To support investigators in navigating the legal and ethical considerations of informed consent.

Summary:

A tutorial was developed by a French network of clinical investigation centers, coordinated by Inserm, to guide the creation of informed consent forms.
The development process involved literature review, surveys within clinical investigation centers, initial drafting, internal review, and external expert validation.
The tutorial integrates legal aspects, participant rights, and information quality to facilitate ethical research conduct.

Impact:

Aims to improve the quality and consistency of informed consent documents in French biomedical research.
Facilitates compliance with European and national regulations for clinical research.
Empowers investigators by providing a structured approach to a critical ethical and legal requirement.