Practical Approach for Collection Study of Human Biomaterials on Intractable Skin Diseases

Abstract

Our research project was to collect human biomaterials, as a part of the Research on Measures for Intractable Diseases of the Ministry of Health, Labour and Welfare, Japan, including human blood and skin tissue from the patients who are affected in 7 different intractable skin diseases. The seven diseases consisted of pemphigus, epidermolysis bullosa, congenital ichthyosiform erythroderma, generalized pustular psoriasis, neurofibromatosis（I・II），xeroderma pigmentosum, and tuberous sclerosis（Bourneville-Pringle diseases）．We are trying to develop bio bank for a continuous medical research for the intractable skin diseases. In order to carry out the study plan, we have the two major problems；first, who has the property for the corresponding human bio materials? Second, who has an official right based on patent law? To resolve the above problems, between patients including their family members and doctors, there should be fiducial qualities on thinking informed consent, based on freedom of choice from the patient side and fairness. Moreover some practical laws including material transfer agreement should be present in Japan.