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Central Ethics Committee for Stem Cell Research

Members of the Central Ethics Committee for Stem Cell Research. Source: © RKI

The Central Ethics Committee for Stem Cell Research (Zentrale Ethik-Kommission für Stammzellenforschung, ZES) was established in 2002 as part of the German Stem Cell Act. The committee is an independent and interdisciplinary expert body whose activities are governed by this law, the act ensuring the protection of embryos in conjunction with the import and use of human embryonic stem cells (Stem Cell Act – StZG) dated 28 June 2002 and by the regulation concerning the Central Ethics Committee for Stem Cell Research and the competent authority pursuant to the Stem Cell Act (ZES Regulation – ZESV) dated 18 July 2002.

The commission, which performs its duties on a voluntary basis, comprises 18 members and deputy members appointed by the Federal Government for a term of three years. The members represent the fields of biology, medicine and philosophical, medical and theological ethics.

The committee’s remit is to review and assess applications for the import and use of human embryonic stem cells (hESCs). For every application submitted, the committee issues an opinion which is then sent to the Robert Koch Institute (RKI), the competent authority under the Stem Cell Act. The committee reviews the ethical acceptability of the applications according to the requirements stipulated in the Stem Cell Act. An application must demonstrate in a scientifically substantiated manner (a) that the research project pursues objectives of outstanding interest for the advance of scientific knowledge, (b) that the scientific issues have already been addressed in preliminary studies using other systems such as embryonic stem cells from animals, and (c) that the targeted increase in scientific knowledge actually requires the use of hESCs. Based on the results of voting on the different scientific and ethical aspects, the commission summarises the outcome of the assessment in a written opinion.

The commission holds 5 to 7 meetings per year at which the applications for the import and use of hESCs as well as the assessments are discussed. Annual reports are submitted to the Federal Ministry of Health (BMG) and can be accessed via the websites of the BMG and the RKI. The executive secretariat of the ZES is located at the RKI as a staff unit of the president’s office. The office of the ZES organises and supports the meetings of the ZES, assists and supports the members and deputy members of the committee in the assessment of applications according to the Stem Cell Act and coordinates the collaboration between the ZES and the RKI, the competent authority.

Date: 14.06.2016