1. Research Ethics-Integrity-Governance

2. University Initiative:The Catalyst? ‘02 Good Research Practice Standards & Procedure to Investigate Potential Research Misconduct established Research Councils UK ‘04 Health care research governance procedures established Department of Health ‘05 Ethics Policy & Procedure for Human Participants established Wellcome Trust ‘06 Clinical trials of investigational medicinal products procedures EU Legislation ‘07 Social care research governance Local Authorities University of Sheffield Timeline Collect ively concerned with governance of research conduct

3. 17/06/2015© The University of Sheffield Research Governance of Health Care Research

4. The term research governance is from the Department of Health’s ‘Research Governance Framework for Health and Social Care’ which contains 20 Standards designed to: Protect Human participants in research Strengthen Scientific quality Clarify Accountabilities & responsibilities Governance of Health Care Research (HCR) 99% of the research affected by this is from the following academic departments and schools 99% of the research affected by this is from the following academic departments and schools: Medicine, ScHARR, Clinical Psychology, Clinical Dentistry, Nursing & Midwifery, Human Communication Sciences & Information Studies

5. 17/06/2015© The University of Sheffield Summary of the Research Governance Standards for Health Care Research - Ethics Review - Informed Consent - Data Protection - Awareness raising - Access to & dissemination of research -Scientific Review - Intellectual Property: Identifying, owning, & exploiting - Appropriate authorisation of research - Written agreements in place - Costing system - Financial probity - Health & safety - Honorary contracts - Monitoring - Adverse Events - Preventing Fraud & Misconduct

6. 17/06/2015© The University of Sheffield “ Nothing endures but change” Growing amount of regulation affecting health care research (HCR) But there’s been greater consolidation & streamlining over the years (smashing bureaucracy) – IRAS is one example of this The research governance process is a linear process with key hurdles (e.g. ethics review) BUT some stages can take place in parallelThe research governance process is a linear process with key hurdles (e.g. ethics review) BUT some stages can take place in parallel It covers project’s whole life (post & pre-award) HCR Governance

7. 17/06/2015© The University of Sheffield Pre-award steps in the process: 1. Q. Is it a health care research (HCR) project? 2. Q. Which organisation will be the Research Governance Sponsor? URMS 3. Register project with the University - on URMS (The University’s Research Management System) IRAS 4. Start filling out forms for NHS Trust registration & for other approvals via IRAS (Integrated Research Application System) 5. Independent scientific approval 6. Independent ethics approval 7. Governance Sponsor authorises project to start HCR Governance Process

8. 17/06/2015© The University of Sheffield What is Health Care Research? 1. What is Health Care Research? Definition: About protecting & promoting public health Undertaken in or by Dept. of Health & NHS Includes clinical & non-clinical research & research by NHS staff using NHS resources Includes research by universities within the health care system that might have an impact on the quality of those services Step 1:

9. 17/06/2015© The University of Sheffield 2. Research Governance Sponsor? This is an organisation (e.g. a university, an NHS Trust, a pharma. company) that takes on overall responsibility for a health care research project from start to final, including: i. the project initiation arrangements (scientific review, ethical review, insurance etc.); ii. the project’s management arrangements (maintaining a site file, ongoing monitoring, reporting adverse events etc.); iii. the project’s financing arrangements. It must satisfy itself that the project meets the Research Governance Framework’s standards & that arrangements are established & in place for management, monitoring, reporting & audit Step 2:

10. 17/06/2015© The University of Sheffield Where the buck stops! Research Governance Sponsor (RGSponsor) is

11. 17/06/2015© The University of Sheffield 2. How to decide which organisation is the RGSponsor? Will the project involve a single NHS Trust? normally YES – NHS Trust will normally be the RGSponsor Is the project multi-centre? YES - University will be the RGSponsor (unless project is a trial of an investigational medicinal product & involves the Sheffield Teaching Hospitals Trust) Will the project involve the NHS? NO - then the University will be the RGSponsor

12. 17/06/2015© The University of Sheffield 3. University Registration - URMS For help with URMS contact the URMS helpline Step 3:

13. 17/06/2015© The University of Sheffield 4. NHS Trust Registration Further info: www.shef.ac.uk/researchoffice/gov_ethics_grp/governance/rgp/rd.html Register for NHS Permission/R&D approval via IRAS (IRAS stands for Integrated Research Application System & is also the route to apply for NHS ethics approval) Step 4:

14. 17/06/2015© The University of Sheffield 5. Independent Scientific Review Route: External peer review - if externally-funded then the award letter constitutes evidence; or Internal peer review (follow expectations of project’s research governance sponsor) - UoS-sponsored: 2 independent reviewers (STH Trust has its own procedure) Step 5:

15. 17/06/2015© The University of Sheffield 6. Independent Ethics Review for research involving human participants [see final set of slides for guidance] Step 6:

16. 17/06/2015© The University of Sheffield 7. Sponsor Authorisation The University as RGSponsor always needs: evidence of URMS registration; and evidence of scientific approval; and evidence of ethics approval If University is not the RGSponsor it needs: written confirmation of sponsorship from the organisation that is the RGSponsor Step 7:

17. 17/06/2015© The University of Sheffield Site File * Set up & maintain a Site File * Adverse Events * Report Adverse Events should they occur * progress reports * Provide Head of Department with standard progress reports (after 3 months, annual, end) * significant developments * Establish arrangements to record, report & review significant developments (i.e. affecting participants, science, management) 7. Post Award Conditions:

18. 17/06/2015© The University of Sheffield Research Ethics

19. 17/06/2015© The University of Sheffield 3 6. - further information: 3 Complementary Ethics Review Procedures NHS University (UoS) Alternative Step 6:

20. 17/06/2015© The University of Sheffield UoS Ethics Review Procedure Remit:  Research project (investigation (to gain knowledge & understanding)  Is led by this University  Involves human participants  Does not involve the NHS  Takes place within the UK

21. 17/06/2015© The University of Sheffield NHS Procedure Remit:  Patients & users of the NHS (recruited due to past/present NHS treatment)  Relatives or carers of patients & users of NHS  Access to data, organs, other bodily material of past or present NHS patients  Fetal material & IVF involving NHS patients  Recently dead in NHS premises  Use of/potential access to premises  Staff (recruited due to professional role)

22. 17/06/2015© The University of Sheffield Alternative Procedure Remit:  Research project takes place in other country then robust procedure in country(ies) applies (robust? – i.e. compared against University procedure)  Research project led by other organisation then robust procedure in organisation applies

23. The Big Picture … - protecting human participants in research Its about: - protecting human participants in research - facilitating high quality research - clarifying accountabilities and responsibilities of individuals & organisations involved in research - ensuring that the public benefits from the research - managing risks - maintaining public confidence in research