French Public Health Code
In forcePrior to the performance of research involving the human person, information is provided to the person participating in the research by the investigator or by a doctor representing the investigator. Where the investigator is a qualified person, this information is provided by the investigator or by another qualified person representing the investigator. In particular, the information covers :
1° The objective, methodology and duration of the research ;
2° The expected benefits and, in the case of research mentioned in 1° or 2° of Article L. 1121-1, the foreseeable risks and constraints, including in the event of the research being terminated before completion;
3° In the case of research mentioned in 1° or 2° of Article L. 1121-1, any medical alternatives;
4° In the case of research mentioned in 1° or 2° of Article L. 1121-1, the medical care arrangements planned at the end of the research, if such care is necessary, in the event of premature termination of the research, and in the event of exclusion from the research;
5° The opinion of the committee referred to in Article L. 1123-1 and the authorisation of the competent authority referred to in Article L. 1123-12 ;
6° Where applicable, the prohibition on simultaneous participation in other research or the period of exclusion provided for in the protocol and his/her entry in the national file provided for in Article L. 1121-16;
6° bis In the case of research for commercial purposes, the arrangements for payment of compensation in addition to the additional costs associated with the research, where applicable, under the conditions laid down in Article L. 1121-16-1 ;
7° Where applicable, the need to process personal data in accordance with the provisions of article 69 of law no. 78-17 of 6 January 1978 relating to information technology, files and civil liberties.
The person whose participation is requested is informed of his or her right to have access, during or at the end of the research, to information concerning his or her health held by the investigator or, where applicable, the doctor or qualified person representing him or her.
The person whose participation is sought or, where applicable, the persons, bodies or authorities responsible for assisting, representing or authorising the research are informed of their right to refuse to participate in the research or to withdraw their consent or, where applicable, their authorisation at any time, without incurring any liability or prejudice as a result.
When the research involving the human person concerns the field of midwifery and meets the conditions laid down in the last paragraph of Article L. 1121-5, the investigator may entrust a midwife or doctor with the task of communicating the aforementioned information to the person undergoing the research and obtaining their consent.
When non-interventional research concerns compliance with a treatment and is carried out in response to a request from the Agence nationale de sécurité du médicament et des produits de santé, the Haute Autorité de santé or the European Medicines Agency, only brief prior information may be provided about the objective of the research, its methodology and its duration, provided that the research does not present any foreseeable serious risk. The project referred to in Article L. 1123-6 shall mention the nature of the prior information provided to the persons undergoing the research.
When the research involving the human person concerns the field of dentistry, the investigator may entrust a dental surgeon or a doctor with the task of communicating the aforementioned information to the person undergoing the research and obtaining their consent.
The objective of psychological research, as well as its methodology and duration, may be the subject of only brief prior information provided that the research does not present any foreseeable serious risk. At the end of the research, full information on the research is provided to the persons who have undergone it. The project referred to in Article L. 1123-6 mentions the nature of the prior information provided to the persons undergoing the research.
Exceptionally, when in the interest of a patient it has not been possible to reveal the diagnosis of his disease, the investigator may, in order to respect his trust, withhold certain information relating to this diagnosis. In this case, the research protocol must mention this possibility.
The information communicated is summarised in a written document given to the person whose consent is being sought. At the end of the research, the person who has given consent has the right to be informed of the overall results of the research, in accordance with the procedures specified in the information document.
