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Human Tissue Act

Are you working with human tissue or blood?

Human cancer cells

1. If you plan to carry out any research with human samples your work MUST have received Ethical Approval from an appropriate body BEFORE you start. In most cases, you also need to obtain approval from the Sponsor of the study. For UCL sponsorship, contact the UCL/UCLH Joint Research Office.

It is the Principal Investigator’s responsibility to ensure that all work performed under their direction has received ethical approval, and that they are aware of all those involved in executing the work, and all such persons are listed as investigators of the ethically approved research project. It is also each researcher’s responsibility to ensure that the project on which they are working has received ethical approval

2. If your work involves storing human tissue in cellular form (i.e. any material consisting of human cells other than gametes and immortal cell lines, in a form where cells are still recognisably present), ethical approval and sponsor approval must be obtained to ensure that your work complies with the Human Tissue Act 2004. Details of this legislation can be found at http://www.hta.gov.uk/legislationpoliciesandcodesofpractice.cfm

3. In most cases using human samples, ethical approval requires the patient’s consent. However, in some cases where samples, collected as part of routine clinical care, are surplus to clinical requirement, and are anonymised so that the researcher cannot identify the donor, the samples may be analysed without patient consent provided ethical approval is given.

4. All ethical approvals are time limited, and project restricted. When approval expires you will need to apply to the relevant ethics committee to extend the study.

Obtaining Ethical Approval. Approval for your study may be obtained via two routes:

a. If human tissue is to be stored within a UCL Biobank, or an external biobank licensed by the Human Tissue Authority, you must obtain ethical approval from that Biobank ethics committee. Biobank ethics committees must be approved by the National Research Ethics Service. There are a number of Human Tissue Authority Licenced biobanks at UCL which have National Research Ethics Committee approval. Information about these UCL HTA Licenced biobanks can be found at HTA Biobanks page. The Designated Individual for each licence can provide details on their Research Tissue Bank approvals and criteria for access.

b. For research studies which are not covered by HTA licenced biobanks, ethical approval for your project will need to be obtained directly from a Research Ethics Committee authorised by the National Research Ethics Service (NRES) – see http://www.nres.nhs.uk/

Students must provide evidence in their log book that they have undertaken training in the requirements of the Human Tissue Act, if they are undertaking research involving human samples. The MRC provides an e-learning course, http://www.byglearning.co.uk/mrcrsc-lms/course/category.php?id=1. The names of students must be added to the list of investigators involved in ethically approved research projects.

Further information about the Human Tissue Act and UCL designated individuals and license holders can be found on the UCL HTA-licensed Biobanks page.