Ethically Sourced Human Biological Materials

As a supplier of human biological material, Cardinal Biologicals understands that we have a crucial ethical duty, and we take that responsibility very seriously. We hold a high set of ethical principles, and we use those principles to guide us every day, in every action we take. All of the raw material supplied by Cardinal is collected with the utmost care and in accordance with strict legal and ethical standards.

Use in Research and Education

Cardinal Biologicals supplies human biological material that is non-transplantable, and is used for medical and pharmaceutical research, diagnostic testing, and education purposes only. We supply raw materials that researchers can further process for use in a direct clinical setting. Cardinal strictly condemns human cloning efforts.

Informed Consent from All Donors

At Cardinal Biologicals, we are firmly committed to patients’ rights. Per our IRB-approved programs, all of our donors give explicit, written permission for their biological material to be collected, and they consent to and understand the purposes for which it will be used. In accordance with HIPAA standards, all donations are de-identified before being supplied to researchers.

Proper Screening

Donors and biological materials are screened for viruses and infectious diseases (e.g., HIV, Hepatitis B and C, Syphilis, etc.), ensuring a high-quality sample. Additional serology testing can also be requested by researchers—all tests are performed in FDA-approved facilities. All results on disease screenings are strictly confidential and follow HIPAA regulations.

From Labor & Delivery Services

Cardinal has long-standing relationships with several regional hospitals who provide labor and delivery services. Through these relationships, we can ensure the safe collection and transport of birth tissue collected after healthy deliveries. The collection of these materials does not interfere with the health, safety, or convenience of mother or baby, and all donations are received with fully informed consent and cooperation from the parents. Mothers also consent to a blood test and brief questionnaire prior to delivery to ensure the disease-free status of the donated tissues.

Birth tissue collected includes placentas, umbilical cords, cord blood, and amniotic fluid, which would otherwise be discarded as medical waste. Through the birth tissue donation process, the amniotic membrane can be extracted and go on to be used in research that is yielding advances in eye surgery, wound care, dental surgery, treatment of spinal cord injuries, and much more. No tissue or samples are collected from sources that could yield potential human life, and we do not collect aborted fetal tissue. Cardinal does not support and strictly forbids supplying to researchers pursuing human cloning. In accordance with our ethical principles, Cardinal supplies birth tissue only to reputable organizations, including ones who are AATB certified.

Catholic Church’s Position on the Use of Birth Tissue in Research

The Catholic Church supports the donation of birth tissue like placentas and umbilical cords for research purposes. The Church directly addresses this in the Ethical and Religious Directives for Catholic Health Care Services, Sixth Edition, stating, “Medical research that will not harm the life or physical integrity of an unborn child is permitted with parental consent” (Part Four, Directive 51). All birth tissue sourced by Cardinal is collected with full informed consent from parents, and tissues are collected only after a healthy delivery, ensuring the mother and child are not harmed or inconvenienced in any way.

The full Ethical Directives document can be viewed via the United States Conference of Catholic Bishops’ website here.

“Medical research that will not harm the life or physical integrity of an unborn child is permitted with parental consent.”

Part Four, Directive 51
Ethical and Religious Directives for Catholic Health Care Services, Sixth Edition

Have Questions?

If you have any questions or concerns about Cardinal Biologicals’ ethical practices, policies, or procedures, please feel free to give us a call at 573-334-5359 or contact us online.