REGULATORY INFORMATION
Not just a duty: Strict adherence to regulation is a philosophy
REGULATORY INFORMATION
Not just a duty: Strict adherence to regulation is a philosophy
Never compromise
HUMAN CELL DESIGN
France has one of the most severe regulatory frameworks in Europe in terms of human sample access and use. Human Cell Design is fully committed to the French ethical and regulatory rules, but also complies with most international regulations. Even though we don’t conduct in vivo trials or studies, we strictly abide by the principles of the Declaration of Helsinki.
HUMAN SAMPLE ACCESS
According to Article L. 1245-2 of the French Code of Public Health modified by Law 2004-800 on August 6th, 2004, all the samples that we use are collected with informed consent signed by the donor
ALL RESEARCH APPLICATIONS INCLUDED
The informed consent form signed by the donor states that the patient’s tissue samples can be used for any research purpose
ETHICAL GUIDELINES
Human Cell Design collection process and double-blind informed consent form have been validated by the Committee for the Protection of Persons (Independent Ethical Committee) (CPP)
GENETIC MODIFICATIONS
Human Cell Design is authorized by the French Department of Research to use genetically modified organisms in confined spaces for research and development purposes. This approval was obtained with a favorable opinion of the Higher Council for Biotechnology (HCB) of the Ministry of Higher Education, Research and Innovation
BIO-BANKING & STORAGE
Human Cell Design is authorized to prepare and store human biological samples for its own research needs or for the purpose of transferring their research to other organizations for their own research programs
