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A is required when storing relevant material for both research and non-research purposes. Non-relevant material does not require a human tissue licence to store.

Relevant material is the phrase that refers to material other than gametes, which consists of human cells. This does not include embryos outside the human body, or hair or nails from the body of a living person. If a sample contains or has the potential to contain even a single cell that has come from a human body, even after processing, then the sample should be classified as relevant material. Please follow this link to a full list of relevant materials:

Storage of human tissue that is classed as relevant material under the Human Tissue Act (2004) can only take place on licenced premises. 快播视频 does not have a Human Tissue Licence. However, there are some exemptions that can be applied in some cases, to allow Human Tissue to be stored at 快播视频 for the duration of a specific project. One of the exemptions must apply to your project in order to store human tissue on campus.

Exemptions:

• Storage that is incidental to transportation to a HTA licence premises;
• very short term storage whilst awaiting processing to render acellular; or
• storage of samples that have been obtained from a research tissue bank that has generic ethical approval from a (more information can be found on this on the drop down below).

If none of the above apply, you are able to apply for project specific ethical approval from an NRES ethics committee such as NHS REC, even where your project is not taking place in the NHS. Project specific ethical approval from an NRES ethics committee allows researchers to store relevant material on non-licensed premises for the duration of your study. However, studies using this route can only retain tissue on campus for the duration of the study approvals. Tissue must be destroyed or returned to a licensed premises for storage.

Some specific research ethics committees (RECs) under the have been authorised to give broad ethics approval for research tissue banks which will then be required to work under NRES standard operating procedures.

These NRES REC approved biobanks are able to provide human tissue to researchers; and the recipients of the tissue are able to store this without a HTA licence during the period of the research project, subject to certain requirements. If the research can not be carried out in accordance with these requirements, a different exemption is required, such as obtaining specific project approval by a recognised NRES research ethics committee.

For projects that use biobank tissue that has been sourced from a biobank with generic NRES approval, whilst specific project NRES ethical approval is not required, faculty research ethics committee (FREC) approval will still be required prior to commencement of the project.

More information on research tissue bank generic NHS REC approval on their .

Human Tissue held under specific project NRES or NHS REC ethical approval must not be retained for future unspecified research after the expiry of project-specific ethical approval. However, an application for ethical approval for a new specific research project using the same tissue can be made. This should be done in good time to pre-empt the expiry of the original project-specific ethical approval.

When applying for an extension to an existing NRES or NHS REC ethical approval, please follow the amendment procedure on the university sponsorship webpage or contact the Clinical Research Governance Officer (sponsorship@lancaster.ac.uk) for assistance.

If an extension, or new project approval has not been sought before the end date of the original ethical approval, samples would need to be transferred to licensed premises until new ethical approval has been obtained.

For tissue obtain from a research tissue bank, you should ensure you return or manage the tissue in the manner agreed when the tissue was released to you.

Alternatively, the samples must be destroyed once the project has been completed. Human tissue is a valuable resource for research, and disposal should always be a last resort.

More specific details around the obtaining, use, storage, management and destruction can be found in the Human Tissue Authority (HTA) codes of practice. There is a specific code of practice for research, which we strongly advise any researchers dealing with human tissue read thoroughly before starting their research.

Non-research specific:

1. All projects that intend to store human tissue should be logged with the clinical research governance team for our records before the tissue is brought to campus. You can do this by emailing the sponsorship inbox. You can also contact us to check if any of the exemptions apply to your project or if you require project specific NRES ethics approval such as NHS REC;

2. Projects that are not required to obtain project specific NRES ethics approval (EG: NHS REC), should also submit an application via REAMs for ethical approval from the Faculty REC. If you are obtaining material from a generic biobank you should still obtain faculty ethics approval via REAMs.

3. Researchers making use of human tissue should also contact their Faculty Biological Safety Committee to check if they have any health and safety requirements.