If your health or social-care study involves any third-party organisations, you can provide them a Local Information Pack (LIP) once the HRA have acknowledged receipt of a valid application.
The LIP will be comprised of your study protocol; significant documents - e.g. PIS and ICF; a copy of your submitted IRAS form; and a formal agreement between parties. The process will be quicker if you are able to use a standard template agreement relevant to the nature of the site and study, see below, and if you have made informal contact with the organisation in advance.
If the study will involve any procedures conducted by NHS staff, or use of NHS resources, you will also be required to include a Schedule of Events Cost AttributionTool (SoECAT) (External). (If you are applying for NIHR funding, this will need to be completed as part of your funding application.)
Organisations at which study activity (recruitment, treatment, investigations etc.) will be conducted are referred to as Sites. Before any study activity can be conducted, there must be an agreement in place between parties. If you have multiple sites, there will generally be one common agreement for all - unless they are conducting different activities.
The agreement(s) will need to be submitted and approved in advance, as part of your IRAS application. Participating sites will also need to be listed in your IRAS application.
A summary of the expected study activity should be provided to the site in the form of an Organisation Information Document (OID). By returning a signed copy of this, the site confirm that they have Capacity and Capability to conduct the study activities.
For non-interventional studies, the OID can also form the collaboration agreement (Appendix 1). Appendices 2 - 6 can be used as an agreement for, respectively, Finance, Material Transfer, Data Sharing, Data Transfer and Intellectual Property.
For interventional studies, the OID is still used as confirmation of Capacity and Capability but the model Non-Commercial Agreement (mNCA) should be used as the contract - see below.
Non-NHS organisations may accept the OID as a collaboration agreement, if not an agreement will need to be negotiated by the Research Contracts Team.
A Participant Identification Centre (PIC) is an organisation whose only participation in the study will be to identify potential study participants and provide their contact details to the study team. PICs do not need to be listed in your IRAS form.
The standard NHS PIC agreement assumes that both parties are NHS organisations and is therefore not always appropriate for use by academic sponsors. As a result, we have drawn up the UoB PIC agreement, which should be used for any study in which the PIC are providing participant details directly to UoB staff.
If you think that collaborators in your study will be acting as PICs, please discuss with Research Governance - for confirmation and the template PIC agreement.
You can find more information about the mNCA on the IRAS help pages. The mNCA should form the agreement between parties for non-commercial interventional research, particularly CTIMPs and CIMDs. It should be used alongside the OID and SoECAT.
In addition to formal agreements, confirmation of capacity and capability is issued by NHS organisations in England and Wales that are participating in a research study, as part of the HRA and HCRW Approval process. This is usually issued along with a signed OID. For sites in Northern Ireland and Scotland, the R&D Permissions process is the equivalent of this.
