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COLLECTION OF BIOLOGICAL SAMPLES

Genoskin’s innovative human skin models use real human skin that is donated after surgery with the informed consent of every individual donor in full respect of the Declaration of Helsinki. Human skin tissue is considered a biological sample and its collection and use have to meet specific legal requirements. Genoskin has specific contracts with every hospital and clinic we work with to make sure the collection of our biological samples follows a very strict protocol. Our human skin models provide an innovative tool for dermatological testing and offer a new alternative to animal experiments.

Biological sample transfer contracts

On August 6th, 2004, France created Law on Bioethics 2004-800 , which was revised under 2011-814 on July 7th, 2011 in order to legally frame the scientific use of human body parts and biological samples. This law was completed by Decree 2007-1220 of August 10th, 2007, which defines the methods of sampling, preservation and preparation of human body parts for scientific use. This decree determines the policy hospital and clinic structures are legally required to follow to transfer human tissue to outside research structures.

Hospital and clinic tissue banks collect excised tissue and organs and can, under certain conditions, grant access to their biological samples to enable research on human tissue and organs that would otherwise be destroyed. In France, the following principles need to be respected:

the donor’s dignity as a civil person, which requires donor anonymity
the res extra commercium principle of the human body, which states that human bodies and body parts cannot be offered for sale, be it by the donor or a third party (French Civil Code, articles 16, 16-1 to 16-9)

Genoskin only works with French hospitals and clinics and has established Biological Sample Transfer contracts with each of them. These contracts fully respect all applicable ethical requirements and legal provisions. To ensure donor privacy while at the same time allowing us to conduct our research in all safety, hospitals and clinics provide the following information on the human skin samples we receive:

age of donor
gender, height & weight
any known skin diseases & conditions
use of corticoids, steroids, topical antibiotics, immunosuppressants or immunomodulators
results of safety tests with regards to Hepatitis B&C & HIV

Using human skin tissue for scientific purposes also requires the approval and authorization of the French Ethics Committee (Comité de Protection de Personnes or CPP) and the French Ministry of Research and Higher Education.