SKIN DONORS & THE DECLARATION OF HELSINKI
Genoskin uses real human skin to create innovative human skin models for research and testing purposes. The human skin tissue we use is donated skin that is left over after a surgical intervention and would otherwise be destroyed. Even though we don’t conduct trials or studies in vivo, we still follow the principles of the Declaration of Helsinki. This Declaration outlines the ethical principles behind research on human subjects, which also includes the results on identifiable human material and data.
Ethical principles for medical research on human subjects
The Declaration of Helsinki is a statement of ethical principles on human research that was first adopted by the World Medical Association in 1964 and has been amended several times since.
The Declaration of Helsinki mainly addresses physicians but encourages other parties who conduct research on human subjects to follow the same principles. It recognizes the importance of research on human subjects while setting the ethical standards for the protection of the subjects’ health and rights in respect of ethical considerations as well as all applicable legal and regulatory requirements.
Before the start of the study, research protocols must be submitted to the Ethics Committee for approval. The functioning of the committee should be transparent, members should be duly qualified and be independent of the researcher, the sponsor and any other undue influences.
Individuals can participate in medical research on an entirely voluntary basis by signing an Informed Consent Form that lists aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions as well as any other relevant aspects of the study.
Informed Consent is equally required to collect, store or use material or data contained in biobanks or similar repositories. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research, in which case the research needs to be considered and approved by a research ethics committee. Genoskin has Biological Sample Transfer Contracts with hospitals and clinics with regard to the skin tissue we use for our human skin models.
The Declaration of Helsinki also sets the framework for the ethical and unbiased publication of results.
French Ministry of Research & Higher Education
Using human skin tissue for scientific purposes also requires the approval and authorization of the Ministry of Research and Higher Education. This French Ministry of Research and Higher Education defines the main guidelines and distributes funds according to specific criteria. It also oversees research organizations and providers of higher education.
Human skin models in full respect of all regulations
Genoskin’s high quality human skin models respect all applicable regulations. As they are created from real human skin that is donated and collected in France, our skin models hold all the characteristics and appendages of in vivo human skin. Our innovative human skin models provide an excellent tool for toxicity and safety testing.