Consent or non-opposition of patients

The establishment of a biological collection is only permitted if the mandatory consent requirements are met.
Consent or non-opposition must relate to the purposes of collection, storage and future use of the samples. The patient may, at any time, revoke consent and object to the use of his or her samples for research. The patient may also request the destruction of his or her samples at any time.

For biological collections requiring genetic analysis (no distinction between constitutional and non-constitutional genetics), the regulations are very strict. It requires precise information on the nature and purpose of the use of the samples as well as written consent (Article 16-10 of the Civil Code).

In the case of deceased patients, it is possible to use the samples for research purposes, including genetic research, by derogation issued by a CPP (Article L1131-1-1 of the Public Health Code).

Declaration of preparation/storage of human biological samples for research purposes

Medical research requires the use of human biological samples, mostly from hospital care. With a view to this use, the law provides a framework for the preparation and conservation of these samples.

The Act provides for the possibility that an organization may carry out preparation or storage activities for the needs of its own research programs or for transfer to other organizations for their research use.

• Preparation or conservation activities for the needs of its own research programmes :

This activity is subject to declaration to the Ministry of Higher Education, Research and Innovation. All collections of biological samples are subject to this procedure. The activities of the Tumorotheque r have been declared since 2009 under the number DC-2009-965.

• Activities of preparation or conservation with a view to transfer to other bodies :

This activity is subject to authorisation from the Ministry of Higher Education, Research and Innovation. The activities of the Tumorotheque have been declared since 2009 under the number DC-2009-965.

Imports and exports of human biological samples for research purposes

The law also regulates the import (receiving biological samples on French territory) and export (sending biological samples from French territory to foreign countries) of biological samples for scientific purposes. These activities are subject to authorisation from the Ministry of Higher Education, Research and Innovation.

The authorisation file contains various information:

• The precise designation of the biological samples concerned;
• The address of the recipient of the samples;
• A description of the scientific programmes for which the import or export of biological samples is envisaged;
• A letter from the investigator certifying the consent or non-opposition of the source patients.

If you wish to obtain authorisation to export biological samples stored by the Biological Resources Platform, please contact the Tumorotheque team.