Research FAQs
Frequently asked questions about research.
Consent to use tissue in research is a novel concept introduced by the Human Tissue Act (HT Act)
This is not true. Asking for consent to use tissue in medical research is current and widespread good practice. It is underpinned by the Declaration of Helsinki and the current General Medical Council (as well as Medical Research Council and British Medical Association) guidelines for doctors on research.
Will the HT Act damage medical research?
No. There is no research that has been conducted in the past, or is currently being conducted, that would be prevented by the HT Act. It simply will require consent or – in the case of tissue from the living (including surplus tissue left over after diagnosis or surgery) – ethical approval by a research ethics authority and anonymisation. This is wholly in line with current good practice.
Will the HT Act mean that a licence will be needed to diagnose a patient or even carry out a blood transfusion?
No. The HT Act does not apply to tissue or cells from living people used for diagnosis or blood used for treatment. (So screening for cervical cancer for example is excluded; and an HTA licence is not needed for storage of blood for transfusion.)
Do I need a licence to store tissue or cells for a specific research project if it has ethical approval?
No. An HTA licence is not needed for storage of tissue for ethically approved research or a specific research project for which ethical approval is pending – the majority of research in the UK. It is required for material stored (e.g. in large biobanks) for which there is no ethical approval.
If I did not get consent for my research project and have archived tissue, including blocks and slides, will I have to get consent all over again? And will I need to have a licence?
The HT Act is not retrospective regarding consent. It is lawful to keep and use tissue samples without consent if they were held before 1 September 2006 – the date on which the requirement for consent comes into force, but a licence would be required if any sample is stored for a Scheduled Purpose (e.g. research).
Would patient consent be needed even to use a tiny bit of residual blood for research?
‘Residual’ blood or tissue from the living can be used without consent as long as the research is ethically approved and the researcher cannot link the blood or tissue to the patient. Consent is not needed to use surplus or residual tissue from living patients left over from diagnosis or surgery for the purposes of
- Public health monitoring
- Education and training (including training in research techniques)
- Clinical audit
- Performance assessment (e.g. testing medical devices)
- Quality assurance.
Consent is needed for any of the HT Act’s Scheduled Purposes where the tissue is from a deceased person.
Can consent from a patient be generic and enduring? If I have to seek repeat consent from patients won’t that be onerous?
Consent can be generic and enduring. The HT Act sets the baseline, saying simply that for storage and use of tissue for Scheduled Purposes to be lawful, consent must be obtained from the appropriate person. The scope of that consent is not limited by the HT Act. Consent can be whatever is agreed in different circumstances, and guidance for obtaining consent is provided in the HTA’s Codes of Practice and other guidance. Anticipating and explaining the purpose for which tissue could be used will avoid the need for seeking repeated consents – for example for research after the patient has had surgery.
Can clinicians do research using tissue from their own patients?
Yes. They are particularly well-placed to ask for their patients' consent. If they wish to do research without asking their patients' consent the research project will need to be ethically approved and they must arrange the research so that they do not have access to information identifying the person from whom the tissue came. This does not mean that the records and tissue must be permanently unlinked.
Do I need consent or a licence to store tissue, cells or DNA to carry out genetic testing?
Both consent and a licence are needed to store any tissue or cells for the purpose of genetic testing – to protect family members. A licence is not required to store DNA.
If my research takes place without consent, because I use anonymised tissue and have ethical approval, does it mean the information cannot be linked to clinical data?
No, it doesn’t. The linked data would need to be anonymised so that the researcher could not know the identity of the person whose tissue was involved. But it does not need to be permanently unlinked. A treating clinician should make arrangements for anonymisation or preferably get consent.
Will valuable research undertaken previously now be impossible without patients' consent, for example the discovery of the link between Helicobacter pylori bacteria and stomach ulcers coming from examination of archived ulcer samples? (Often cited as an example of what may be lost to UK science as a result of the HT Act, this groundbreaking research into the cause of ulcers actually took place in Australia.)
No. Studies like this could take place in future without patients' consent if ethically approved and the tissue has been anonymised. Use of existing tissue holdings (a body of a deceased person, body parts or material from a body held before 1 September 2006) does not need consent. Again, services could also introduce procedures asking for (generic and enduring) consent to research at the time samples are taken.
Can I keep organs or tissue following Coroners’ autopsies for research, for example to check the prevalence of CJD in the population?
According to the HT Act, consent from the deceased person, a person nominated by them, or a ‘qualifying person’ (usually family members) will be needed to carry out any research or public health monitoring on tissue from the deceased. After Coroners have completed their work the body and tissue must either be
- Disposed of sensitively
- Returned to the family
- Consented for use for another Scheduled Purpose such as research, plus health monitoring.
Do I need a licence to store stem cells (including bone marrow stem cells) to treat patients?
Yes. A licence is needed if tissue or cells are stored for the intention of treatment as of 7 April 2006. This includes stem cells from adults and children. The HT Act does not apply to material created outside the body, so cell lines are currently excluded from the HT Act. When the EU Tissue and Cells Directive (EUTCD) is transposed into law it will be within the remit of the HTA to license establishments using cell lines for human application, however, a licence will not be needed for research on cell lines.
Do I need a licence to store tissue form living people?
An HTA licence is not required if human tissue is stored for a specific research project which has ethics committee approval or is pending approval.
If researchers wish to retain tissue for future, unspecified research, then a licence under the HT Act will be required. Application for a licence should be made in good time: we recommend at least three months before the current research project ends.
Alternatively, an application for ethical approval for the new research project should be made in good time to coincide with the end of the current research project.
The samples will need to be transferred to an existing licensed store until either a licence is granted or ethical approval has been obtained.
Human tissue is an invaluable resource for research, and disposal should be a last resort.
Most research institutions and NHS establishments have a licence from the HTA so researchers should be able to transfer human tissue to a licensed store in their own organisation.
List of research establishments licensed by the HTA
Do I need a licence to store tissue collected for diagnosis?
Whether the storage of tissue is licensable under the Human Tissue Act (HT Act) depends on the primary purpose for which the tissue is taken and stored.
- If the primary purpose for taking the tissue is for diagnostic purposes, then storage of that tissue is not licensable under the HT Act.
- If the primary purpose for taking and storing tissue is for research, then storage of the tissue is licensable under the HT Act. Tissue stored for research that does not have Research Ethics Commitee (REC) approval must be stored under a licence granted by the HTA.
Applying the policy
If tissue taken primarily for research is stored alongside other tissue that is stored for diagnostic purposes, the whole premises fall under the HT Act for licensing purposes.
Tissue held in a diagnostic archive (which, by applying the policy described above, is not licensable under the HT Act) may be used for a research project without changing the status of the diagnostic archive for the purposes of the HT Act. In other words, the primary purpose for taking and storing that tissue has not altered: it was taken and stored primarily for diagnostic purposes rather than research.
A research laboratory is, for the purposes of the HT Act and Regulations, an end-user and can hold tissue for that research project without a licence, providing it is approved by a Research Ethics Committee (REC).
Once the research is completed, tissue can be stored in the laboratory without a licence only if it is being kept for purposes, eg. audit, relating to the completed REC-approved project. Residual tissue cannot be stored for future unspecified research projects without a licence under the HT Act.
What constitutes ethical approval?
NRES (formerly COREC) has introduced a new system to allow tissue banks to seek ethical review. Tissue banks that receive ethical approval will still need an HTA licence as the approval is generic rather than a specific project approval.
The HTA regards ethical approval as approval gained from NRES research ethics committees (or the equivalent in devolved countries) or UKECA-recognised ethics committees. We have talked at length to NRES and held a joint workshop with the research community, so any forthcoming NRES guidelines should dovetail with the HTA’s Code of Practice on Consent, which gives clarity to practitioners on these issues.
Further information
A number of best practice documents concerning human tissue and medical research are available from the UK Clinical Research Collaboration’s website. These help researchers meet the requirements for research with human participants, their tissues or data.
These are available online (under heading 'human tissue').