If you are planning to create a research database or a research tissue bank (‘biobank’) then the following information may be helpful.
Research tissue banks
A research tissue bank or biobank is a collection of human tissue or other biological material, which is stored for potential research use beyond the life of a specific project with ethical approval or for which ethical approval is pending.
HRA Approval is not required for the establishment of research tissue banks (RTB), but organisations responsible for the management of RTBs anywhere in the UK may apply on a voluntary basis for ethical review of their arrangements for collection, storage, use and distribution of tissue.
Obtaining ethical approval for a tissue bank may offer benefits such as facilitating programmes of research without a need for individual project-based ethical approval.
Where voluntary application is made to a REC for ethical review of a research tissue bank, a favourable opinion is conditional on the following being in place:
- A licence from the Human Tissue Authority (if the research tissue bank is storing ‘relevant material’, as defined by the Human Tissue Act 2004)
- Registration of the resource in the UKCRC Tissue Directory
All NHS organisations are expected to have included management review in the process of establishing a research tissue bank and, where applicable, applying for licensing of a research tissue bank.
There are standard conditions which should be followed after a REC favourable opinion has been issued or for non REC studies after HRA Approval has been issued. For research tissue banks, the RTB Conditions of Approval should be used.
Tissue collection centres
HRA Approval is also not required by collaborators at tissue collection centres (TCCs) who provide tissue samples, other biological material and/or data under the terms of a supply agreement between the care organisation and the research tissue bank. TCCs are not research sites for the purposes of the UK Policy Framework for Health and Social Care Research.
If the TCC is storing relevant material as defined by the Human Tissue Act 2004, there are licensing implications to be considered. The TCC will require a HTA storage licence unless the relevant material is being stored: (i) incidental to transportation’ (the timeframe for this is up to one week); or (ii) pending processing to extract DNA or RNA, or other subcellular components that are not relevant material (the timeframe for this is also up to one week).
Further details on these licensing exemptions are given in the HTA’s Code of Practice and Standards on Research (Code E).
Studies using tissue from RTBs
HRA Approval may be needed for project-based studies that use research tissue from registered banks, depending on the activities in the NHS and the scope of the ethics favourable opinion for use of research tissue by the Bank.
Applying for ethical review of a RTB
When applying for ethical review the 'research tissue bank' option in IRAS should be used.
Further information and guidance can be found in section 12.20 of the Standard Operating Procedures for Research Ethics Committees.
An overview of the REC process can be found in the Approvals and amendments section of this site.
A research database is a structured collection of individual-level personal information, which is stored for potential research purposes beyond the life of a specific research project with defined endpoints. Research purposes in this context refers to analysis of data to answer research questions in multiple projects.
HRA Approval is not required for the establishment of research databases.
Organisations responsible for the management of research databases anywhere in the UK may apply on a voluntary basis for ethical review of their arrangements for collection, storage, use and distribution of data, including arrangements for release of non-identifiable data for analysis by external researchers. However, there is no general requirement for research databases to apply for ethical review under the UK Policy Framework for Health and Social Care Research.
Applications can be made for generic ethical approval for Research Databases, which has the advantage that specific research projects can be undertaken using the non-identifiable data without needing a separate ethics review each time. Where generic ethical approval has not been granted for the research database, a separate ethics review for any individual research projects conducted using the data would need to be applied for.
There are standard conditions that should be followed after a REC favourable opinion has been issued or for non-REC studies after HRA Approval has been issued. For research databases, the specific standard conditions of the REC favourable opinion for Research Databases should be applied.
Where the activities of a research database would include accessing or otherwise processing the identifiable data of patients or services users in England and Wales outside the normal care team without consent, a favourable ethical opinion from a Research Ethics Committee (REC) is required by law, and an application to the Confidentiality Advisory Group under Section 251 of the NHS Act 2006 should be made to set aside the common law duty of confidentiality owed by care professionals to their patients or clients.
Further information and guidance can be found in section 11 of the Standard Operating Procedures for Research Ethics Committees.
Data collection centres
HRA Approval is not required by collaborators at data collection centres (DCCs) who provide data under the terms of a supply agreement between the care organisation and the database. DCCs are not research sites for the purposes of the UK policy framework for Health and Social Care Research.