Seeking Approvals: Which approvals are needed?

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Introduction

This station will help you establish which approvals are required in particular circumstances. For more detailed information and the process for submission, please see the relevant stations further along this Route Map.

Ethical Approval
– It is a requirement of the UK policy framework for health and social care research that ethical review by an NHS Research Ethics Committee (NHS REC) is conducted on all research involving NHS patients or social/community care (see Ethical approval). It is also good research practice for all studies involving people as participants to be ethically reviewed, either by an NHS REC or other committee. In certain circumstances NHS REC review will be a legal requirement, for example when ethics approval will be used as an exemption to the need for an HTA licence, or to conduct research involving adults who lack capacity to consent (see Adults unable to give consent for further guidance). Further guidance on determining whether NHS REC review is required can be found in the 1st resource below.  Applications for NHS REC approval should be made using IRAS (see 2nd resource below). In England NHS REC review is part of HRA Approval, see below.

R&D management permissions - In England NHS Research & Development (R&D) Management permission has been superseded by HRA Approval (see below). Individual NHS organisations in England will make an assessment of their capacity and capability to deliver the study. In the devolved administrations NHS management permission is required from all NHS organisations hosting research projects that involve NHS patients (including their data and/or tissues) or NHS resources (see R&D Management Permissions). Individual sites in the devolved administrations also require Site Specific Information (SSI) Forms. This can include access to diagnostic archives held within Pathology (specific approval from Pathology is also required, see Approval for access to existing collections below).

Employing universities or research units should be notified of all research activities that involve their staff or premises. Some may need to approve such projects before they can begin, particularly if they are being asked to sponsor the project. More information is available in Discuss sponsorship and agreements and Confirm sponsor(s).

Applications for HRA Approval or NHS R&D management permission, including SSI Forms, should be made using IRAS (see 2nd resource below).

HRA Approval – HRA Approval is required for all project-based research in the NHS led from England (including portfolio, non-portfolio, commercial and non-commercial, those requiring review by an NHS REC and also those not requiring NHS REC review). It combines NHS research ethics committee review (where needed) with the legal and governance checks that NHS organisations used to perform.  HRA Approval does not apply to Research Tissue Banks, Research Databases and studies taking place only in non-NHS sites.  With HRA Approval investigators’ correspondence with individual NHS sites will be about their capacity and capability to deliver the study. Please see HRA Approval – What you need to know  for more information including what to do when a study has sites in England and a devolved administration(s).

Section 251 Approval – this is required for research studies that propose to access or use identifiable NHS patient information without consent in England or Wales.  Please see the 3rd resource below or the station: Section 251 approval for more information.  In the other nations of the UK, approval from Caldicott Guardians in Scotland, and Medical Directors in Northern Ireland should be obtained.

IRAS (Integrated Research Application System)
IRAS is a single system for applying for the permissions and approvals for health and social/community care research in the UK. It streamlines the process for seeking relevant approvals as you do not need to enter all of the details for a single project separately into each of the relevant application forms. For more information, please visit the IRAS website (2nd resource below).

HTA licence – The Human Tissue Authority licenses a number of activities relating to human tissue, e.g. the storage of relevant material for a scheduled purpose such as research (England, Wales and Northern Ireland), or human application (all of the UK). Licences are issued per premises, not on a per project basis. There are a number of licensing exemptions, which are further outlined in HTA licence.

HFEA licence – The Human Fertilisation and Embryology Authority regulates the creation, storage and use of embryos in research throughout the UK. Licences are issued on a per project basis (for more detail see HFEA licence).

Approval for access to existing collections – If proposing to use an existing collection of data or tissues, such as a diagnostic Pathology archive for example, it is likely that an application to the database or tissue custodian will be required. The requirements and processes will differ depending on the custodian and advice should be sought from the data, tissue bank or Pathology archive in question. See Approval for access to existing collections

NHS Digital (formerly Health and Social Care Information Centre (HSCIC))– Applications for access to Registration, Cancer and GP Administration data and Hospital Episode Statistics (HES) are reviewed by the NHS Digital Data Access Request Service. For more detail see Central NHS and Government Data and the 4th resource below.

Public Benefit and Privacy Panel  - NHS National Services Scotland Privacy Advisory Committee was merged with the Community Health Index Advisory Group (CHIAG) and National Caldicott Guardians to form the Public Benefit and Privacy Panel for Health and Social Care. This panel advises on requests to access patient information from more than one NHS board in Scotland. To access patient information held within one NHS board in Scotland, advice should be sought from the individual Caldicott Guardian. For more information, see Privacy Advisory Committees.

Privacy Advisory Committee (PAC) - Northern Ireland has a Privacy Advisory Committee (PAC) that was established to oversee the implementation of recommendations agreed by the Ministers on Protecting Personal Information. For more information, see Privacy Advisory Committees.

Resources

  • 1. HRA / MRC Decision Tool: Do I need NHS REC approval?

    This decision tree, developed by the Medical Research Council (MRC) Regulatory Support Centre on behalf of the Health Research Authority (HRA) will help you determine if your study requires NHS REC approval.

    Legal requirement for specific research projects Date added: 28 May 2013
  • 2. IRAS: Integrated Research Application System

    Link to the new Integrated Research Application System for research in the Health Service.

    Standard process for all research Date added: 14 December 2007
  • 3. HRA CAG Section 251 approval

    Guidance for applications to the Confidentiality Advisory Group (CAG) of the Health Research Authority (HRA) who are responsible for providing section 251 approval under the NHS Act 2006.

    Legal requirement for data Date added: 20 August 2010
  • 4. NHS Digital Data Access Request Service

    NHS Digital provides health information to support medical researchers.

    Standard process for data Date added: 26 September 2008