Ethical approval processes for research Andy Scally, FoHS April 2017 11 November, 2017 Ethical approval processes for research

Ethical approval processes for research Key decisions to make Am I doing ‘research’, ‘audit’ or ‘service evaluation’? Does my study require me to obtain primary data? Does my study involve recruitment of patients accessed through the NHS? Yes: IRAS application, but processed through UoB approval process before submission – save copy of completed IRAS form and submit to UoB for approval before continuing IRAS submission. No: UoB ethics approval process only (even if audit or service evaluation!). However, you may still need NHS R&D approval if you are using NHS resources. 11 November, 2017 Ethical approval processes for research

NHS organisations and systems IRAS: ‘Integrated Research Application System’ Web portal for electronic submission of applications for relevant approvals HRA: ‘Health Research Authority’ Overarching body responsible for the regulation of research in the NHS – assesses governance and legal compliance. Remit is for England only. Compatible systems elsewhere in the UK. RES: ‘Research Ethics Service’ Formerly NRES, now part of HRA. Governs the ethical approval processes for research involving patients REC: ‘Research Ethics Committee’ Constituted under HRA/RES. Comprises a panel that considers ethical issues in submissions and grants ethical approval. Panels throughout geographical regions of England/Wales. Scotland/Northern Ireland have similar processes. R&D: ‘Research and Development’ governance office NHS organisation department regulating research in that organisation. NHS Trusts/CCG’s/Primary Care organisations. 11 November, 2017 Ethical approval processes for research

UoB organisations and systems CER: ‘Committee for Ethics in Research’ University body with oversight of university ethical approval processes REP: ‘Research Ethics Panel’ Humanities, Social Sciences and Health Studies Research Ethics Panel Biomedical, Natural, Physical Sciences and Health Studies Research Ethics Panel IRAS Application Review Panel Explanation of UoB processes found at: http://www.bradford.ac.uk/rkts/research-support/ethics/processes/ 11 November, 2017 Ethical approval processes for research

When is NHS ethical approval required? When it is research involving patients How do I know if it’s ‘research’? Make your own judgement … Then seek advice from Academic supervisor Research Ethics Committee office/Chair Local NHS R&D office Use HRA decision tool - http://www.hra-decisiontools.org.uk/research/ For audit and service evaluation there will often still be ethical issues that need to be addressed, but you will not need formal NHS ethical approval; however, you will need UoB approval

Is it research, is it audit or is it service evaluation? Not always an easy answer! Research Generation of new (generalisable) knowledge Audit Evaluation of local practice, possibly against a reference standard Service evaluation Evaluation of the degree to which a local service meets user needs I’ve seen several local instances of audit and service evaluation mutating into research! See http://www.hra.nhs.uk/research-community/before-you-apply/determine-whether-your-study-is-research/ for further advice

Applying for NHS research ethics approval Only necessary if it is ‘research’ and involves the active recruitment of patients or involves individually identifiable patient data or tissue If using ‘anonymised’ patient data, seek further advice Go to IRAS website, create an account and carefully go through the tutorial on the website Complete the application process and upload all supporting documentation (consent forms, PIS, letters of invitation, CV for Chief Investigator, Statement of Activities and Schedule of Events forms, insurance/indemnity certificates, etc.) Send pdf to UoB research ethics office for our internal approval process Once UoB approval is received, complete the application process, ensuring correct contact details for UoB as sponsor. Telephone HRA immediately prior to submission. If the application is all in order, HRA will assign the application to a REC 11 November, 2017 Ethical approval processes for research

Applying for NHS research ethics approval You will be invited to the committee meeting to answer questions relating to your application REC decision can be a) ‘approved’, b) ‘conditional approval’, c) ‘provisional approval’ or d) ‘not approved’ If b), minor amendments will be required; if c) a little more work will be required; if d) then a lot more work will be required followed by a new submission. In parallel with the HRA application, the study needs to be registered with the relevant NHS R&D governance office(s), who need to sign off the ‘Statement of Activities’ and ‘Schedule of Events’ forms. The R&D office needs to ensure the Trust/organisation has capacity to support the project. 11 November, 2017 Ethical approval processes for research

Applying for UoB ethics approval Required for all student and staff projects, even if they don’t fit the HRA definition of ‘research’. All checklists and full applications must be signed off by the academic supervisor. If HRA approval is also required, follow the procedure previously outlined If HRA approval is not required, follow the UoB procedure outlined here: http://www.bradford.ac.uk/rkts/research-support/ethics/ All studies require a ‘checklist’ to be completed If the ethical issues relating to your project are very minor, this may be all that is required Checklist is ‘signed off’ by the relevant REP Chair 11 November, 2017 Ethical approval processes for research

Applying for UoB ethics approval Continued … If there are more than minor ethical issues, then a full application will be required The application will be sent to two reviewers, who may: a) ‘approve’, b) ‘require minor amendments’, c) ‘require major amendments’ or d) ’reject’ If response from both reviewers is a) or b), then the reviews will be sent to the applicants for a response (if required); if the response is satisfactory, then the application will be approved by the appropriate Panel Chair If response from either reviewer is c) or d), then the application will be sent to the full Panel for review; a report will then be sent to the applicant for response. 11 November, 2017 Ethical approval processes for research

Ethical approval processes for research Summary Ethical approval processes can seem very complex and off-putting, but … They are essential to protect research participants, researchers and the integrity of the university You are not alone! Seek advice and support from your supervisor You and your supervisor will also have access to expertise within the university, the HRA and the NHS Please see the Ethics Training web pages for training opportunities to help you further http://www.bradford.ac.uk/rkts/research-support/ethics/training/ 11 November, 2017 Ethical approval processes for research

Ethical approval processes for research Thank you This section should contain any caveats or copyright information, or information and contact details or the author. Lorem ipsum dolor sit amet, consectetur adipisicing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. 11 November, 2017 Ethical approval processes for research