INFORMED CONSENT OF HUMAN SKIN DONORS
According to Article L.1211-2 of the French Code of Public Health, which was modified by Law 2004-800 on August 6th 2004, no elements of the human body can be collected without prior consent of the donor, who can revoke his or her decision at any time. It is possible to use elements and products of the human body for medical or scientific purposes, other than the preliminary surgical intervention, except when the donor expresses his or her refusal. This regulation also applies to the use of human skin for testing purposes.
The informed consent form
The human skin tissue used in our human skin test models is obtained with the Informed Consent of every individual donor. An Informed Consent form is a document that is given to potential donors before they undergo surgery that involves taking away some skin tissue, such as plastic surgery in the abdominal region (the so-called tummy-tuck procedures), cosmetic surgery at the arms (brachioplasty), etc..
By signing the form, the donor agrees to donate the excised skin tissue to Genoskin instead of having it destroyed. This consent allows us to further develop our human skin models as an alternative to animal testing. Donors are also informed of the purpose of our human skin models.
It is also clearly stated that potential donors can always refuse to donate excised skin with no effect whatsoever on their surgical procedure or treatment. In our experience, however, most donors gladly accept to help science move forward by donating skin that would otherwise simply be destroyed.
The skin tissue used in Genoskin’s human skin models is obtained via French hospitals and clinics. Genoskin has specific Biological Sample Transfer Contracts with these institutions and complies with all applicable regulations.
Genoskin uses the donated skin to create human skin models that are the closest alternative currently available to in vivo clinical testing. Our human skin models are used to test chemical, cosmetic and pharmaceutical products in order to further their development while limiting potential risks.