Innovations in Responsible Research with Health Data Research Ethics in FBMH Lynne MacRae Research Practice Governance Manager Faculty of Biology, Medicine and Health (FBMH)

Faculty Research Governance Team Based in FBMH but working across all faculties Support researchers conducting research in the NHS Act on behalf of University when Research Governance Sponsor Applications and amendments for NHS ethics and HRA approval Audit ongoing studies

When is ethical approval required? Projects conducted by University staff or students that involve human participants in a way that might harm, disturb or upset them (however slight the possibility) or where they can be deemed to be in a vulnerable or disadvantageous situation, must receive approval from a recognised research ethics committee (REC). Issues: Autonomy Confidentiality Individual risks and societal benefits Two routes to ethical approval: - NHS REC - University REC (UREC)

University of Manchester Ethics Decision tool http://www.training.itservices.manchester.ac.uk/uom/ERM/ethics_decision_tool/story.html Is this NHS Research? Yes No HRA Decision tools (external) University Research Does it require ethical approval? No Ethics 1. Is it research? No No Yes Yes Unsure 2. Does it require NHS REC review? No Ethics signatory Yes UREC or School/Division committee NHS REC

UK Policy Framework Research Definition For the purpose of this policy framework, research is defined as the attempt to derive generalisable or transferable10 new11 knowledge to answer or refine relevant questions with scientifically sound methods12. This excludes audits of practice and service evaluations. It includes activities that are carried out in preparation for or as a consequence of the interventional part13 of the research, such as screening potential participants for eligibility, obtaining participants’ consent and publishing results. It also includes non-interventional health and social care research (i.e. projects that do not involve any change in standard treatment, care or other services), projects that aim to generate hypotheses, methodological research and descriptive research. Projects whose primary purpose is educational to the researcher, either in obtaining an educational qualification or in otherwise acquiring research skills, but which also fall into the definition of research, are in scope of this policy framework. Activities that are not research according to this definition should not be presented as research and need not be conducted or managed in accordance with this framework. A decision tool that provides a definitive answer about whether a project counts as research under this policy framework is available at www.hra-decisiontools.org.uk/research.   10 NB This definition involves an attempt at generalisability or transferability, i.e. the project deliberately uses methods intended to achieve quantitative or qualitative findings that can be applied to settings or contexts other than those in which they were tested. The actual generalisability or transferability of some research findings may only become apparent once the project has been completed. 11 Including new knowledge about existing treatments or care. 12 Projects that are not designed well enough to meet this definition are not exempt from this policy framework – see paragraph 9.10.a. 13 This means the part of the research where a change in treatment, care or other services is made for the purpose of the research. It does not refer to other methodological ‘interventions’, e.g. issuing a postal survey. UK Policy Framework for Health and Social Care Research (2017), p.6 https://www.hra.nhs.uk/documents/1068/uk-policy-framework-health-social-care-research.pdf

Is it research or service evaluation/audit? Intention: Research aims to derive new knowledge, audit or service evaluation measure standards of care Treatment/service: neither service evaluation or audit use an intervention without firm basis of support Allocation: neither audit or service evaluation allocate treatment or service by protocol. Measures what is decided by clinician and patient Randomisation: if used, it is research Where to get help Health Research Authority (HRA) and Medical Research Council (MRC) have developed online tool to help determine if a study is research or service evaluation/audit: http://www.hra-decisiontools.org.uk/research/ HRA Defining Research table: http://www.hra-decisiontools.org.uk/research/docs/DefiningResearchTable_Oct2017-1.pdf - this is also linked to in the HRA decision tool referenced above. Research and Development Forum (2006) Categorising research within the Research Governance Framework for Health and Social Care https://warwick.ac.uk/services/ris/research_integrity/researchethicscommittees/biomed/guidance_on_categorising_research_audit_evalulation.pdf - this is an old document and so some of the terminology is out of date but, the principles are sound. HRA queries line: hra.queries@nhs.net Trust Research & Development (R&D) Offices: http://www.rdforum.nhs.uk/content/contact-details/

UREC School/Divisional approval NHS REC Ethics Required: Prospective collection or retrospective use (secondary analysis) of patient or service user data for research purposes. Exemption(s): Use of previously collected, anonymous data where there is no intention for use in research at the time of collection i.e. anonymous clinical data Secondary analysis of patient data collected for research purposes – in line with consent. UREC School/Divisional approval Ethics Required: Prospective collection of data for research Where certain conditions apply: Prospective collection of data for non-research activities Secondary analysis of previously collected data Exemption(s): Secondary analysis of data that is: Fully anonymous Data controller permission In line with consent Issues to consider: Consent – does re-use of data really align with original consent? Anonymisation – is the data anonymised or pseudonimysed? Could it be linked?

Section 251 Support Common law duty of confidentiality Section 251 of the National Health Service Act 2006 Allows individuals to access identifiable patient data without consent Applications assessed by the Confidentiality Advisory Group (CAG) NHS REC approval required Data stored in Data Safe Haven (DSH)

NHS Sites NHS organisations have responsibility for patients, staff their tissue and data Need to be aware and agree to research studies taking place at their site and/or involving patients or staff Includes studies limited to the use of anonymised data even if exempt from NHS REC review England and Wales: Health Research Authority (HRA) and Health and Care Research Wales (HCRW) approval Northern Ireland: http://www.research.hscni.net/approval-research-hsc Scotland: http://www.nhsresearchscotland.org.uk/services/permissions-co-ordinating-centre/permissions

Integrated Research Application System (IRAS) NHS REC If required HRA Assessment Governance checks carried out by the HRA on behalf of the NHS. HRA and HCRW Approval (England and Wales) Integrated Research Application System (IRAS) HRA Approval Other approvals Confidentiality Advisory Group (CAG) Medicines and Health Care Products Regulatory Agency (MHRA) Administration of Radioactive Substances Advisory Committee (ARSAC) Her Majesty’s Prisons and Probation Service (HMPPS)

Assurance for NHS organisations that HRA-approved Study Assurance for NHS organisations that The study has all approvals in place e.g. ethics approval It meets all legal and policy requirements There are appropriate agreements in place for the study Site 1 Do we have capacity and capability to host? Site 2 Do we have capacity and capability to host? Site 3 Do we have capacity and capability to host?

Sponsorship Review Review NHS REC/HRA approval before submission Prepare NHS REC/HRA and HCRW application Review NHS REC/HRA approval before submission IRAS form Study docs DMP Insurance assessment form Does it meet University requirements? Do other offices need to be involved? Can the University carry out sponsor responsibilities? Final draft application to Faculty governance team for sponsorship review Sponsorship review Changes required? 15 working days Clock stops when action is with research team No Yes UREC + HRA approval studies Apply for UREC first ‘Light touch’ sponsor review No DMP No insurance assessment form Changes made and re-submitted Final checks Confirmation of sponsorship authorise IRAS

University support Central Research Governance, Ethics and Integrity Team Develops and monitors University and provides guidance and support to researchers in the area of research governance, integrity and ethics. UREC (including ethics decision tool) Data Safe Haven and NHS IG Toolkit Clinical Trials/ Medical Devices Human Tissue Act http://www.staffnet.manchester.ac.uk/services/rbess/governance/ Faculty Research Governance Team (FBMHethics@manchester.ac.uk) University-sponsored research conducted under the UK Policy Framework for Health and Social Care Research All studies except clinical trials of investigational drugs and medical devices NHS Ethics HRA approval http://www.staffnet.manchester.ac.uk/bmh/research/ethics-and-regulatory-support/ If you are using IRAS, you need to speak to the RGT!