Ethics

Before carrying out any research with human samples, it is necessary for the project to have received Ethical Approval from an appropriate body. In most cases, approval from the Study Sponsor is also required. For UCL sponsorship, contact the UCL/UCLH Joint Research Office.

Ethical approval for your research

Principal Investigator's responsibility:
Ensure that all research performed under PI direction has received ethical approval, and that those performing the work have had appropriate training in 'working with human tissue', health and safety issues, and Information Governance. All researchers involved in a project must be listed as investigators on the project delegation log. The name must be removed when a researcher terminates their research.

Researcher's responsibility:
Ensure that the project on which they are working has received ethical approval.

Use and storage of human tissue

If research involves the use and storage of human tissue in a cellular form, that is any material consisting of human cells other than gametes and immortalised cell lines, in a form where cells are still recognizable, ethical approval and R&D approval must be obtained to ensure that your work complies with the Human Tissue Act 2004. R&D approval should be obtained from the UCL/UCLH Joint Research Office. Details of the human tissue legislation can be found at www.hta.gov.uk/guidance-professionals.

1. In most cases undertaking research on human samples requires ethical approval and requires the patient's consent. However, in some cases where samples, collected as part of clinical care, are surplus to clinical requirement, and can be anonymised so that the researcher cannot identify the donor, the samples may be studied without consent from a patient. However, ethical approval is required for this.

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

Ethical approval is always required before tissue and / or data can be accessed for research purposes. Once the Health Research Authority has approved an application for undertaking research, there is no requirement for tissue to be held on HTA-licensed premises although those undertaking the researcher must work to HTA standards.

There are a number of Human Tissue Authority-Licensed Biobanks at UCL. The HTA-licensed premises in the UK are available at www.hta.gov.uk/establishments. The type of HTA licence required must permit the storage of human tissue samples for the scheduled purpose of research.

Ethical Approval for research on human tissue and or clinical information is given by the Health Research Authority (HRA), formerly known as the National Research Ethics Service (NRES) although the Health Research Authority can authorise a local Biobank Ethics Committee to grant ethical approval.

Approval for research on human tissue and or clinical information may be obtained via the following routes:

A1. Ethical approval to access human tissue stored within a Human Tissue Authority-Licensed Biobank for research purposes can be obtained from a Local Ethics Committee which has been authorized by the Health Research Authority to give ethical approval. However, most biobanks within or external to UCL are not regulated by a local ethics committee but one such biobank is the UCL/UCLH Biobank for studying Health and Disease.

A2. Ethical approval for access to human tissue from a HTA-licensed Biobank which is not authorised by the Health Research Authority to grant ethical approval for research projects, can be obtained by applying to the Health Research Authority. Once Health Research Authority ethical approval has been granted, tissue does not have to be held on a HTA-licensed premises although those undertaking the researchers must still work to Human Tissue Authority Standards.

B. Ethical approval for using human tissue which is not stored in a HTA-licensed Biobank is obtained by applying directly to the Health Research Authority for a project-specific ethics approval (www.hra.nhs.uk). Such applications are required to specify what samples are to be collected, stored and what research is planned to be undertaken. These samples do not need to be held on HTA-licensed premises although those undertaking the researchers must still work to Human Tissue Authority standards.

C. The UCL Ethics Committee provides ethical approval for research involving volunteers who may not be NHS patients; for example cohorts who answer questionnaires, give blood samples to be used as control material. Any tissue approved for such studies must be used for research purposes within 7 days or stored on a HTA-licenced premises. For further information, please refer to ethics.grad.ucl.ac.uk