If you are establishing a new collection of human samples, then it is important to seek consent that is both broad in scope and duration to allow for storage and future use.
Two phase consent, where donors are asked about the initial project, and for storage and future use in other research projects, is recommended. Consent arrangements should be reviewed by a Research Ethics Committee (REC).
If you intend to access an existing collection of human samples for your research, for example from a biobank or a collaborator, you should work with them to determine what is required in terms of ethical approval.
You should also speak to your local research office for their policy on human samples and ethical review, as well as how to manage any transfer of samples. If parties agree that appropriate consent is in place, and your project does not pose any ethical issues, you may not require REC review.
You can search the UK Clinical Research Collaboration (UKCRC) tissue directory to discover human samples available for use in research.
Regarding arrangements for storage, you should speak to relevant local contacts to discuss storage arrangements and ensure that these can be provided.
Exactly who you should speak to will depend on how human samples are managed within your research organisation, but this is likely to be your:
- local lab manager
- health and safety contact
- designated individual (if you have one).
If you are based in England, Wales or Northern Ireland, your lab may operate under a Human Tissue Authority research licence (supervised by a designated individual).
If you are based in England, Wales or Northern Ireland and your lab is not covered by a licence, you will need to meet the licensing requirement of the Human Tissue Act 2004 if you intend to ‘store’ relevant material for your research.
The most common way to meet the licensing requirement on unlicensed premises is with NHS or Health and Social Care REC approval (as this provides a legal exemption for licensing).
If you are accessing relevant material from a UK-based biobank that has generic ethical approval, then their approval can extend to you and provide you with a legal exemption for licensing.
If you need a legal exemption for licensing, please check whether the biobank provides such ethical approval, as well as any other conditions placed on your use of their samples.
There are other licensing exemptions. You can find more in using human samples in research.
You should attach a ‘letter of support’ or equivalent if you are accessing samples from a biobank that confirms that your request is feasible and has been adequately costed. If additional storage is required for your research (for example, a new freezer or off-site storage), this can be costed into your grant.
5.7.1 Using human embryos, admixed embryos, embryonic stem cells or lines
If your research involves embryos or the derivation of embryonic stem cells or lines, then it may be regulated by the Human Fertilisation and Embryology Authority (HFEA).
You can read about the HFEA’s requirements for research in section 22 of their Code of Practice. The Code of Practice details clear limits on the use of embryos in research as well as requirements for consent and licensing (‘Licences for research’ details when you need an HFEA research licence).
Learn more about applying for an HFEA research licence.
5.7.2 Xenotransplantation
If your proposal includes the use of animals containing human material, you must follow the Home Office guidance on the use of human material in animals.
5.7.3 Developing cell and tissue-based therapies
If your research will develop a cell or tissue-based therapy, then human application requirements apply pre-trial stage. You can learn more about these requirements (procurement, testing, processing, storage, distribution, import and export of tissues and cells) in the Human Tissue Authority’s guidance on human application.
For guidance on the trial stage, please also see clinical trials of investigational medicinal products, including advanced therapies.