Cytes Biotechnologies, S.L. complies with all ethical standards and regulations applicable to the acquisition, handling, and supply of human and animal biological products for basic research. Therefore, we guarantee the activities related to the processing of tissue samples are managed by us or our direct collaborators, and ultimately are carried out in accordance with the mentioned standards and principles.
Human tissue acquisition and all associated processes are performed in Spain in accordance with Spanish and European legal requirements. Donor’s consent, quality, safety, and traceability of the generated material are Cytes Biotechnologies, S.L.’s priorities. Donors do not receive any economical compensation. Furthermore, our isolation processes are part of an approved project by the Bioethical Committee for Clinical Research of the University of Barcelona since October 9th, 2015.
All human products are in accordance with
these applicable laws and regulations:
· Spanish Legislation: Law on Biomedical Research 14/2007, Law on Data Protection and Guarantee of Digital Rights 13/2018, Royal Decree 1716/2011.
· European Legislation: 2004/23/EC, 2006/17/EC, 2006/8/EC.
· Ethical principles: Nüremberg Code (1946), Helsinki Declaration (2013), Belmont Report (1978) and Oviedo Convention (1997).
Our commitment to informed consent for human donors:
We pride ourselves on committing to the informed consent of our donors and ensure that they voluntarily confirm and are willing to participate in our particular research project. They also understand our objectives, potential risks and benefits, and the overall intended collection of biological samples for research purposes. Ultimately, our participants are provided with appropriate information and have the opportunity to resolve their concerns so that they can make an informed decision.
Animal tissue acquisition and all associated processes are performed in Germany with accordance to German and European legal requirements. There are ethical, scientific, legal and economic reasons to ensure the appropriate use of animals for research. For this reason, we follow the principle of the 3Rs (Reduce, Replace, Refine) through the development and distribution of its multiple in vitro research models.
All acquisition of animal tissue is performed
in accordance with these permits:
· 3902-046-2017 and DE 13 076 0001 21 from the Landkreis Ludwigslust-Parchim, Department of Veterinary- and Foodstuff Control in accordance with EU Regulation No. 1029/2009, Art. 17 and 23.
· Permit 7221.3-2-004/17 from the Ministry for Agriculture, Food Safety and Fishery of the State Mecklenburg-Pomerania in accordance with EU Regulation 2010/63/EU.
· TierSchG dated July 18, 2016 and TierSchVerV dated August 31, 2015 used for experimentation and other scientific purposes.