Ethics & Quality
Ethics and Quality: Policy and Practices
Statement on Ethical Research
DV Biologics considers strong ethical principles to be a necessary and integral part of scientific research, especially when it comes to the use of donated biological materials. We only accept tissue that would otherwise be discarded as a byproduct of a medical procedure. Tissue donation has zero effect on the donor’s medical care. All biological material is obtained through informed consent, and donor privacy is protected and respected.
Each informed consent form is written to take into account the specific type of biological material being donated and to communicate the intended research uses to the potential donor. All forms are reviewed to protect the rights and privacy of all donors and to ensure that tissue is collected in accordance with scientific, ethical and regulatory guidelines.
Protecting the Privacy of Donors
We understand that the procurement, storage and use of human biological material are an essential part of research. DV Biologics is dedicated to protecting the privacy of individuals that act as donors to further these research efforts. We work intimately with a network of hospitals and physicians to protect donor privacy at all times and to make certain that all donations are given anonymously.
Statement of Quality
At DV Biologics, it is our mission to pursue ways to continuously improve the quality of our products and services. We comply with internal quality policy as well as with the international standards for Quality Management Systems as defined by the ISO 9001:2008. To that end, our Quality Management System was certified by IAPMO R&T in 2012, and certification has since been maintained with the most recent 2015 renewal effective through 2018. A copy of the certificate is available here.
Our work product is governed by a system of formal standard operating procedures (SOPs). SOPs govern the entire process from processing tissue through shipment to the customer. After meeting or exceeding internal requirements, each product is sold with a complete Certificate of Analysis that indicates test results for cell count and viability, sterility assurance and pathogen testing, and donor information.