Start of work on information notices and patient consent forms – principle of free and informed consent – for genetic testing in a health care setting (rare diseases and cancers)
The first task addressed by the working group was to provide professionals with operational documents in an ethical manner, necessary to start the first sequencing.
Indeed, two types of documents must be submitted to patients by the medical specialist before any diagnosis in the framework of the plan:
- The information notice provides, in written and accessible form, the scientific, technical, regulatory information required for the best possible understanding of the test proposed to the patient. This document is designed to accompany the patient in his/her care and should be proposed as early as possible. The physician is also available to the patient to answer any further questions.
- The consent form is signed by the patient during the consultation that precedes genetic sampling and analysis. It shows the patient’s choices in relation to a number of options subsequent to the tests, regarding amongst others information for family members (relatives) in the event of a positive result, or making the patient’s genetic data (anonymised) available for research.
The broad composition of the working group responsible for the creation of these two types of documents made it possible to take into account all the subjects identified.
The working group also sought support from the output from many forums.
The Parliamentary office for evaluating scientific and technological choices (OPESCT), professional and learned societies in genetics at national, European and international level, as well as the framework of several European projects made it possible to lay solid foundations for reflection.