Help - Preparing & submitting applications - Site specific information
Help
  • Using IRAS
  • Preparing & submitting applications
    • HRA ApprovalHRA Approval
    • NHS/HSC R&D PermissionsNHS/HSC R&D Permissions
    • Ethical review (REC)Ethical review (REC)
    • Confidentiality Advisory Group (CAG)Confidentiality Advisory Group (CAG)
    • ARSACARSAC
    • HMPPSHMPPS
    • MHRA MedicinesMHRA Medicines
    • Site specific informationSite specific information
    • MHRA DevicesMHRA Devices
    • Templates for supporting documentsTemplates for supporting documents
    • Radiation AssuranceRadiation Assurance
    • Radiation - defining research exposuresRadiation - defining research exposures
    • Pharmacy AssurancePharmacy Assurance
  • Maintaining your approvals
  • End of research
  • FAQs
  • Documentation
  • Reference
Site specific information

Site specific information



IRAS has the functionality to create three types of site level information form. These are: This page also provides information about Participant Identification Centres (PICs).



NHS/HSC Site Specific Information (SSI) Form

The NHS/HSC Site-Specific Information Form (SSI) Form is used as part of the NHS/HSC permission process for research at NHS/HSC local research sites in Northern Ireland and Scotland.

The NHS/HSC SSI Form should only be completed after Parts A–D of the integrated dataset in IRAS have been completed because elements of the NHS/HSC SSI Form are populated by these sections of the integrated dataset.

The Chief Investigator (CI) should transfer the NHS/HSC SSI Form to the Principal Investigator (PI) or Local Investigator at the site for completion.

Guidance on how to apply to conduct research in NHS/HSC organisations is provided in the NHS/HSC R&D Permissions page of IRAS Help.

Guidance on the submission requirements for your NHS/HSC SSI Form is set out below. Please refer to the section that relates to the location of the participating NHS/HSC organisation.

Quick links:
England / Wales
Northern Ireland
Scotland
Cross-border arrangements for provision of NHS/HSC local site-specific information for cross-border studies




  • England and/or Wales

  • NHS SSI forms are not used for NHS research sites in England and/or Wales. Researchers wishing to conduct research in the NHS in England and/or Wales apply through HRA and HCRW Approval. Please refer to the separate guidance for site level information for participating NHS organisations in England and Wales under HRA and HCRW Approval.



  • Northern Ireland

  • For further guidance on seeking HSC R&D Permission for participating HSC organisations in Northern Ireland please refer to HSC website.



  • Scotland

  • For further guidance on seeking NHS R&D Permission for participating NHS organisations in Scotland please refer to the NHS Research Scotland website 



  • Cross-border arrangements for provision of NHS/HSC local site-specific information for cross-border studies

  • Work is continuing in collaboration with colleagues from the 4 Nations to develop a UK-wide NHS/HSC Local Information Pack. Once agreed, the Local Information Pack will be incorporated into IRAS and will replace the current arrangements for sharing of local information across the UK.

    More details will be available in due course.

    Until further UK-wide guidance on local information can be agreed and issued, the interim position for management of local NHS/HSC site information is as follows:
    • NHS/HSC Site Specific Information (SSI) forms will continue to be used for setting up studies in Northern Ireland and Scotland.
    • NHS SSI forms will not be used for sites in England and Wales. Local information should be provided according to HRA and HCRW guidance
    • Research studies led from England and/or Wales with research sites in Northern Ireland and/or Scotland will continue to use NHS/HSC SSI forms for the NHS/HSC sites in Northern Ireland and Scotland only.
    • Research studies led from Northern Ireland or Scotland with NHS sites in England and/or Wales should provide local information in accordance with HRA and HCRW requirements. Sponsors (or authorised delegates) are advised to contact HRA or HCRW teams (please see linked page for contact information) at the earliest opportunity so that they can, for the English and/or Welsh NHS sites: facilitate the completion of information requirements; confirm with the sponsor that the information is correct; and facilitate the review of the research study for these sites.



    Back to the top



    Non-NHS Site Specific Information Form

    Site-specific assessment (SSA) is an assessment of the suitability of the local research site and investigator to conduct the research. SSA for non-NHS sites is only required as part of the ethical review for some types of research – refer to Section 5 of the UK Health Departments’ Research Ethics Service Standard Operating Procedures for more information and guidance on SSA procedures. For other types of research taking place at non-NHS sites, application for SSA is not required. All sites listed in the application to the REC, and any other sites added during the course of the study, will be deemed to be ethically approved as part of a favourable opinion from the REC. Management permission is still required from the organisation responsible for hosting the research before it commences at any site.

    Where SSA is required for non-NHS site(s), you will need to create non-NHS Site Specific Information (SSI) Form(s) and electronically submit the form and supporting documentation, as indicated on the Checklist tab. Please refer to the E-submission tab for the non-NHS SSI form for guidance and instructions on how to submit the application.

    Back to the top



    ARSAC Research Certificate Application (RCA) Forms

    On 6 February 2018, the Administration of Radioactive Substances Advisory Committee (ARSAC) changed the way it grants approvals for research. As of this date, site specific ARSAC Research Certificate Applications (RCA) Forms are no longer used and therefore do not need to be completed in IRAS. The project level Preliminary Research Assessment (PRA) form is still used. Please refer to the Administration of Radioactive Substances Advisory Committee (ARSAC) website for information on how and when to submit research applications to ARSAC, including what site level arrangements you will be expected to have in place.

    Further guidance may also be sought from the ARSAC Support Unit.

    Back to the top



    Participant Identification Centres (PICs)

    What is a PIC?
    A PIC is where an organisation:
    • Identifies participants, largely (but not exclusively) through patient records, for possible participation in studies
    • Provides information about / or informs patients directly about a study, e.g. a clinician speaks directly to a patient
    • Advertises the opportunities to participate in a specific study, e.g. via posters in waiting rooms
    and
    • Where the research is taking place elsewhere.


    An organisation is not acting as a PIC when it is responsible for:
    • Any protocol-specified assessment to determine participant eligibility for a study, e.g. a screening blood test or x-ray
    • The recruitment (informed consent) of participants into a research study
    • The delivery of research procedures specified in the research protocol


    How do I apply?
    To enable NHS/HSC organisations to operate proportionate approaches to NHS/HSC permissions, researchers are recommended to:
    1. Consider the use of PICs at the study design/feasibility stage
    2. Approach relevant NHS/HSC organisations to discuss their in-principle support to act as a PIC
    3. All activities/ resource requirements proposed for PIC organisations must be detailed within the IRAS Form. You will need to answer YES to A73 to reveal the secondary PIC questions and include the contact details and activities of PICs associated with research sites (except where the activity is limited to displaying leaflets or posters only). Details of PICs should be entered in Part C of the form.
    PIC activity for NHS organisations in England and/or Wales may only commence once HRA and HCRW Approval has been issued and the instructions regarding the necessity or otherwise of the organisation acting as a PIC and the research site to confirm their capacity and capability to take part has been followed.

    PIC activity for organisations in Northern Ireland and/or Scotland may only commence once NHS/HSC permission is granted by both the research site and the organisation acting as a PIC.

    What will be reviewed by the PIC?
    Organisations that are considering whether to act as a PIC will primarily rely on the completed study-wide governance review. The local governance review at the organisation acting as a PIC will only consider:
    • The resource implications for the PIC site
    • If the patient information is clear about who is hosting the research and who will provide compensation for clinical negligence


    Back to the top



    Page last updated: 1 July 2018



     
    IRAS Integrated Research Application System, version 5.11, 19/02/2019, IRAS Dataset version 3.5.
    The Health Research Authority (HRA) acknowledges the Integrated Research Application System (IRAS) partners in developing IRAS content. © Health Research Authority 2019.
    Copyright and other intellectual property rights in the content of the Integrated Research Application System (IRAS) belong to the HRA and all rights are reserved. Terms & Conditions, Privacy Policy.