Human biological samples

The use of human tissue and biological samples in research can contribute to a better understanding of human health and disease. Researchers working with human biological material should be aware of the legal and ethical issues arising from their use.

The following policies and principles outline UKRI’s expectations for UKRI-funded researchers whose research involves human biological samples.

Key principles

Samples should be treated as donations and research involving samples should be conducted with respect and transparency

The human body and its parts should be treated with respect. Before approaching potential donors, researchers should be aware there may be individual, cultural or religious differences in the meaning and significance attached to the body or specific parts of it. Researchers should aim to achieve an environment of trust and respect with participants. A high level of transparency should be maintained, for example, from seeking consent for the potential future use of samples, to making research results available.

Potential benefits from the research should outweigh any risks to the donors

The physical risks in donating samples for research will usually be minimal, but the risk that information from laboratory tests or linked data of a sample might harm the donor or their interests must not be overlooked.

Maximise the use of samples to benefit science and society.

Wherever possible, researchers should make use of existing resources in an ethical manner with respect and transparency for the donors, rather than collecting new samples. New and existing collections can be made more useful through choice of sample preparation and storage techniques.

Decide whether and how to feedback any health-related findings

Researchers must decide at the outset what their strategy will be regarding feedback of health-related findings to individual donors. Detailed guidance is available in the Wellcome Trust/MRC Framework.

The human body and its parts shall not, as a rule, give rise to direct financial gain

Researchers may not sell for profit samples they have collected as part of UKRI-funded research, and research participants should never be offered any financial inducement to donate samples. Payment of reasonable expenses or costs is acceptable, however.

Information provided to potential donors should be understandable and helpful

When seeking consent, the potential donor (or an appropriate person on their behalf) must be informed and competent to make the decision to participate or not. When obtaining consent, you should consider the value of those samples for future research and, if possible, seek broad and enduring consent to include storage and use for future research.

Patients should be informed when material left over following diagnosis or treatment might be used for research

Samples collected during routine diagnostic procedures are a valuable resource for researchers. The use of diagnostic samples without consent is legally permitted in certain circumstances (by the Human Tissue Act 2004 and Human Tissue (Scotland) Act 2006).

Research involving human biological material should undergo independent ethical review, with very limited exceptions

This safeguards the rights, safety, dignity and well-being of research participants and ensures, where applicable, that legal requirements in tissue legislation are met. This review is normally carried out by a research ethics committee (REC) within the NHS or a university.

There are certain low-risk situations where REC review may not be legally or ethically necessary. For example, when samples are being used within the terms of consent, there are processes in place to ensure this, and the research team are not able to identify donors.

Researchers should treat as confidential all personal and medical information

The value of human biological material can be maximised by maintaining links with personal or clinical data relating to the donor. People who donate samples for research must be told what data about them will be used in the research, who it might be shared with, and what safeguards are protecting their confidentiality.

The ethical and legal principles are detailed in the MRC Regulatory Support Centre’s information on using data about people in research.

Researchers should keep up to date with all ethical, legislative, regulatory and governance requirements

This includes working with teams and individuals within relevant organisations who have a corporate responsibility to ensure that these requirements are met.

Guidance on legislation

You can find guidance on the legal and ethical requirements in the MRC Regulatory Support Centre’s information on using human samples in research.

UKRI policies and guidance

Human tissue and biological samples for use in research

Provides guidance on the ethical use of human biological samples in research.

Framework on the feedback of health-related findings in research

A framework to help you develop a strategy for individual health related findings. This includes considering whether any individual findings should be fed back, and if so, how this might be done.

Code of practice for the use of human stem cell lines

Good practice guidance for research involving human stem cell lines, including requirements for human embryonic stem cell lines.

External guidance

The guidance below has not been developed directly by UKRI, but may be a useful resource. Where this advice conflicts with UKRI-produced policies and guidance, UKRI policies and guidance should be followed.

Nuffield Council on Bioethics

Learn about the work of Nuffield Council, such as recent work on the ethical issues of stem cell therapy and past publications such as ‘Human Bodies: Donation for medicine and research’.

UKCRC Tissue Directory and Coordination Centre

You can search UKCRC’s tissue directory to discover human biological samples available for use in research.

NC3Rs resource hub: increasing human tissue use

For guidance on using human tissue models, to help reduce the reliance on animals in research.

This is the integrated website of the seven research councils, Research England and Innovate UK.
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