FAQs 1. I am applying for a grant for my study, who in R&D can help me with this? It is important that you cost your research study effectively, to ensure that adequate funds are requested for the lifetime of the study. Contact ACCORD about your intention to apply for funding as early as possible and well in advance of the application deadline. ACCORD Research Governance, Edinburgh Research Office and NHS Lothian Finance Teams work closely together to provide help, ensuring you capture the correct funding, identify NHS costs and establish which organisation will administer your grant. Contact the Edinburgh Research Office and ensure that your draft application is also sent to ACCORD and NHS Lothian Finance. 2. Is my study research, service evaluation or audit? The Health Research Authority (HRA) ‘Is my study research’ decision tool and ‘Defining Research’ table can provide guidance on this. If you are still unsure, send your study outline or protocol to ACCORD for advice. 3. How do I get sponsorship approval? ACCORD SOP GS003 Sponsorship Approval covers what is required by the ACCORD Research Governance team to start a sponsorship review. ACCORD SOP CR007 Study Documents provides useful document templates for e.g. protocols, Participant Information Sheets, Consent Forms etc, that you should use to prepare your study documents prior to submitting for sponsorship review. Send your draft research study specific documents, including a draft IRAS form, to the team. 4. Does my research study need a favourable opinion from an NHS Research Ethics Committee (REC)? If the research study involves NHS patients (including their data and/or their tissue), it is likely that a favourable opinion from an NHS REC will be required. If research participants are not NHS patients, a favourable opinion from a University of Edinburgh REC will be required if you are a University of Edinburgh employee or student. If your study is locally sponsored (by University of Edinburgh and/or NHS Lothian), your assigned sponsor representative will provide guidance during sponsorship review of the study on which approvals are needed. Refer to ACCORD Standard Operating Procedure (SOP) GS003 Sponsorship Approval. 5. Does my research study need NHS R&D management approval? If the study involves undertaking the research on the premises of a NHS organisation, with NHS patients or with NHS staff, R&D permission/management approval will be required. The process for seeking NHS R&D permission can be found on the Integrated Research Application System (IRAS). 6. I do not know the process for seeking REC/R&D approval, can you help? If your study is locally sponsored (by the University of Edinburgh and/or NHS Lothian), your assigned sponsor representative will provide further guidance on seeking the required approvals for the study. You can also obtain further guidance under the ‘Help’ function on the Integrated Research Application System (IRAS). 7. Do I need REC/R&D approval for my service evaluation or audit project? No, service evaluation and audit projects do not require a favourable opinion from an NHS REC or R&D management approval. In addition, sponsorship is not required. These studies do need to be registered with the local NHS Quality Improvement Team (QIT) in the Boards/Trusts participating in the study, and guidance should be sought from the local QIT to check if Information Governance and/or local Caldicott approval is required. 8. Does my research database need a favourable opinion from an NHS REC and/or R&D management approval? There is no requirement for research databases to apply for ethical review under the UK Policy Framework for Health and Social Care Research. However, 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. Where a research project requires researchers to undertake additional procedures involving subjects, other than data collection arrangements described in the database application, this is not covered by generic approval for the database. Additional research procedures should have further ethical review, either as a substantial amendment to the terms of generic approval for the database, or as a separate application for ethical review of a specific project. A research database does not require sponsorship. A study accessing a research database does require sponsorship and must be conducted in accordance with a favourable opinion from a REC. If the research database has a favourable opinion, such a study could be conducted in accordance with that opinion, depending on the scope of the opinion. R&D management approval is not required for the establishment of a database. However, researchers wishing to access NHS patient data from research databases in order to answer specific research questions, must seek study specific R&D management approval. Further reading: HRA guidance on research tissue banks and research databases. 9. Does my research tissue bank (‘biobank’) need a favourable opinion from an NHS REC and/or R&D management approval? R&D management 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. Further reading: HRA guidance on research tissue banks and research databases. Please contact the NHS Lothian Tissue Governance team to seek further guidance. An RTB does not require sponsorship. A study accessing an RTB does require sponsorship and must be conducted in accordance with a favourable opinion from a REC. If the RTB has a favourable opinion, such a study could be conducted in accordance with that opinion, depending on the scope of the opinion. 10. Does my study need Caldicott approval? If your study is locally sponsored (by the University of Edinburgh and/or NHS Lothian), your assigned sponsor representative will provide further guidance during sponsorship review of the study on which approvals are needed. The NHS Lothian Caldicott Guardian oversees the arrangements for the use and sharing of patient identifiable information, including for the purposes of research. This oversight is required where patient specific consent is not possible or practical. The approval is subject to the research study meeting the 7 Caldicott Principles. The process for seeking NHS Lothian Caldicott approval for research can be found in ACCORD SOP GS008 Personal Identifiable Information: Caldicott Approval and Information Governance Review. Note that NHS Lothian policies dictate that Caldicott approval is required under certain circumstances even when explicit consent is in place e.g. for the use of a mobile device that will store personal data. 11. Does my study need to be reviewed by NHS Lothian Information Governance/IT Security? When reviewing a research study, prior to issuing R&D permission, a check of IT systems/software or other methods used to process NHS Lothian personal data is required e.g. where personal data is being transferred to a non-NHS organisation or a web-based system is being used to capture personal data. This decision is made by ACCORD when reviewing study documents, and in consultation with NHS Lothian Information Governance & IT Security, where required (see ACCORD SOP GS008 Personal Identifiable Information: Caldicott Approval and Information Governance Review. More information on NHS Lothian IG/IT procedures is available here. If you are aware that your study will need an NHS Lothian IG/IT review, we recommend that you engage with the R&D IT Information Project Manager in advance of the study undergoing R&D review, to initiate the process. 12. How do I get a research passport? You can find detailed guidance on the Research Passport application system under the ‘HR Good Practice Resource Pack’ on the Integrated Research Application System (IRAS). NHS Lothian R&D will issue honorary research contracts or letters of access to researchers where required in accordance with ACCORD SOP GS006 Research Passports.