Human tissue and cell line related applications

If your research involves human tissue, samples or cell lines you may require ethical approval. Whether or not ethical approval is required, and if so what approval, depends on the type of tissue being used.

When research involves the use of tissue outside of Scotland, researchers must make themselves aware of and act in accordance with any applicable legislation.

Researchers should bear in mind that transfer of tissues between organisations, including a research site and the University, requires that they contact Research Business Development and Contracts to put in place a material transfer agreement.

Research involving the NHS

NHS approvals must be obtained first and then ratified by a School ethics committee. Get in contact with researchgovernance@st-andrews.ac.uk to check whether you will need any NHS approvals and, if so, which approvals you will need and how to obtain them. Get in contact as early as possible as acquiring NHS approvals may take months. When applying for NHS ethical approval, researchers are still required to use the University's template documents.

Definition of tissue

Tissue is defined as material that has come from a human body and consists of, or includes, human cells.

This includes a wide range of tissue types such as skin, blood, saliva, hair and nails.

This does not include cells manufactured outside of the human body (for example, established cell lines) or extracted cellular components in which no whole cells remain (for example, extracted DNA and RNA).

Tissue acquired directly from subjects

Projects acquiring tissue from living subjects require ethical approval and, if collected from NHS patients or on NHS property, ethical approval from the NHS.

Tissue acquired from licensed tissue banks

Projects using tissue acquired from a licensed NHS tissue bank require a letter of approval from the tissue bank. The letter of approval plus a copy of the application made to the tissue bank must be submitted to the School ethics committee (SEC) with the first page and signature pages of the ethical review application form (Word).

Cell lines

Ethical approval is only required for:

• projects involving primary cell lines, i.e. the cultivation of cells from tissue acquired during the project
• EU-funded projects involving embryo-derived cell lines.

External resources

The Medical Research Council (MRC) has a 'Regulatory Support Centre' with links to legislation relating to human tissue, applicable for Scotland, updated in 2016.