Regulatory framework

LABORATORY

We are allowed to conduct the laboratory activity by the following:

CLINICAL SITE

In addition to research and clinical state institutions, ilaya Medical Company, which has the license of the Ministry of Health of Ukraine for medical practice and the accreditation certificate of the first category, constitutes the base for carrying out a part of clinical trials.

GUARANTEES

In addition, the Order of the Ministry of Health of Ukraine No. 630 “On Approval of the Procedure for Conducting Clinical Trials of Tissue and Cell Transplants and the Examination of Materials of Clinical Trials and the Modification of the Procedure for Conducting Clinical Trials of Medicinal Products and Examination of Materials of Clinical Trials” entered into force on October 10, 2007, allowing the use of cell and tissue materials for clinical trials. Control over the conduct and maintenance of clinical trials is carried out by the Coordination Center for the Transplantation of Organs, Tissues and Cells of the Ministry of Health of Ukraine, after providing relevant documentation and reports. And the research participant shall sign the informed consent of research participant and donor.

According to the Convention on the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, ilaya Medical Company and ilaya Science Project protect the dignity and identity of all people and guarantee to each individual, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.

The Helsinki Declaration of the World Medical Association “Ethical Principles of Human Researches Involving Human Subjects” states the ethical principles of medical research involving a human being as a research object, including studies on human material and data that can be identified.

Before conducting a research, a clinical trial specialist prepares a Research Protocol which researchers and all structural subdivisions of the project are obliged to keep to.