Human Biological Samples

Human Biological Samples (HBS) and data derived from them play a vital role in the discovery, development, and delivery of new treatments to patients. HBS underpins our research and development from early discovery through to clinical development. 

What are Human Biological Samples?

Human Biological Samples (HBS) include any materials taken from a living or deceased person that contain human cells. Examples include:

• Blood, urine, and other body fluids
• Cells or tissues
• Organs
• Genetic material such as DNA or RNA
   

We treat all genetic material as HBS because information in DNA and RNA has potential to identify an individual.

Every sample represents a generous contribution from an individual who has chosen to share a part of themselves to help advance science. Their donation may help researchers develop new tests, medicines or treatments, to aid prevention, detection, improve or even cure health problems.

We have a responsibility to treat these contributions with respect and care – respecting informed consent, protecting donors’ privacy, honouring their wishes, and following all relevant laws and ethical standards. We use samples donated in our clinical studies, collected through collaborations, and obtained from trusted external partners and institutions. You can view our public policy on Human Biological Samples.

Human embryonic stem cells and fetal tissue

In rare circumstances we may use human fetal tissue and human embryonic stem cells in research because it can provide invaluable data to advance novel treatments for serious diseases. In these rare instances, the scientific validity of the research proposal will be reviewed and permission to use the tissue will be granted only when there is no other scientifically reasonable alternative available. We require our external partners and tissue suppliers to meet the same high ethical and quality standards. At the same time, we continually work to reduce the need for these materials by exploring new scientific and technological alternatives.

Ethical approval framework for use and re-use of HBS

All research carried out on HBS is subject to ethical consent in accordance with the informed consent and use outlined in the clinical trial/research protocol. Before any research is carried out using HBS, ethical approval must be in place and the research must align with the informed consent given by the donor at the time their sample was collected.

Key safeguards include:

• Any request to use samples – either now or in the future – must be reviewed and approved by a designated HBS Guardian at AstraZeneca.
• All research must match what the donor agreed to in the consent form and have a relevant active ethical approval in place from a Research Ethics Committee (REC)/Institutional Review Board (IRB).
• If required by local regulations, additional approval may be obtained from a REC/IRB.
   

When donors have given broad or future-use consent, further ethical review may or may not be needed for subsequent specific uses, depending on what the original approval covered and the rules in each country. In circumstances where additional review or approval is required, this will be sought as required in line with relevant regulations from:

• Original REC/IRB
• Country/Regional Ethics Committee or relevant Biobank Ethics (e.g. UK Research Tissue Bank approval)
• Independent ethics committee
• Institutional ethics/governance framework*
   

* For research that can be approved internally under our ethical framework – and still falls within the donor’s original consent – we maintain an internal list of approved projects.

Veeva ID: Z4-86178
Date of preparation: August 2026