ACCORD UPDATE EVENTS 2019 Sponsorship and R&D
R&D review – why? If your research involves NHS patients, data, tissue, facilities, your research cannot proceed without formal approval from the Research & Development Office(s) at each of the NHS Boards/Trusts in which your research is to take place. R&D approval ensures that the legal obligations of the board are met provides indemnity for research projects under the Clinical Negligence and Other Risks Indemnity Scheme (CNORIS) is a condition of ethical favourable opinion
R&D review – how busy are we? In 2018 297 studies given R&D approval 719 amendments received, 695 amendments approved
R&D review – the process Sponsorship OR Site selection Joint submission to Ethics and R&D via IRAS, picked up by NRSPCC IRAS form Protocol Information sheets and consent forms Site Agreement 3. Site Specific Information Form (SSI) accord@nhslothian.scot.nhs.uk CVs and GCP certificates
SPONSORSHIP APPROVAL IS NOT R&D MANAGEMENT APPROVAL R&D review – the process 4. The R&D review* National governance checks (Generic Review – 10 days) Lothian specific checks (Local Review – 15 days) Head of service oversight Service department support Caldicott Letter of access/honorary contract 5. Management approval SPONSORSHIP APPROVAL IS NOT R&D MANAGEMENT APPROVAL
R&D review – the process Are the submitted study documents validated and signed? Is the proposed work legal? Does the study have a favourable ethical opinion (from an appropriate REC)? Does the study conform to NHSL policies? Are the appropriate regulatory authorisations in place? Are there any Caldicott issues to be addressed? Are there any Information Governance issues to be addressed? Does the study have support of the service departments? Is there adequate insurance/indemnity cover? Budget/contract negotiation? Are the researchers adequately qualified (CV, GCP)? Do the researchers hold substantive or honorary NHS contracts? Has the study been appropriately registered?
R&D review – devolved nations England and Wales – Health Research Authority (HRA HCRW Approval) Confirmation of capacity and capability Northern Ireland – Application Gateway (HSC management permission) R&D/Management approval
R&D review – amendments UK process – 35 calendar day review/default approval Category A, B, or C Category C amendments implemented (with regulatory approval) Applies to both substantial and non-substantial The 35 calendar day period starts on receipt of a full amendment submission
R&D review – amendments CATEGORY A CATEGORY B CATEGORY C Impacts or affects ALL participating NHS organisations Needs to be considered and may need change control actions Impacts or affects SPECIFIC participating NHS organisations Only at these organisations does it need to be considered and take any change control actions required No impact on NHS organisations Does not require management or oversight. R&D do not need to be notified of such amendments, however will have access to all documents within their national IT system.
Questions? For general enquiries please email enquiries@accord.scot Documents specific for R&D Management Approval should be submitted to accord@nhslothian.scot.nhs.uk Main Office: 0131 242 3330