Ethics – where to start!

1. Ethics – where to start! October 2013 Lois Neal FMS Research & Innovation Office

2. Why is ethical review needed? • To ensure good practice in research • To deliver research with credibility • To safeguard the researcher & explain • to the world that the work is acceptable • To minimise risks

3. Where and how to start? • A good research proposal • Clearly defined question • An investigation that will answer the question • Suitable data collection • Appropriate analyses • A written protocol • Peer Review

4. AND early consideration of ethics: • Preliminary ethical assessment (Stage 1) • http://www.ncl.ac.uk/res/research/ethics_governance/ethics/procedures/staff_review.htm • Retain the form with your protocol!

6. Preliminary Ethical Assessment Stage 1 To find out: • Is formal ethical review needed? If needed, b) Which authority should it come from?

7. Which Authority? • Ethical Review Committee at the University • set up by the Home Office • Research Ethics Committees (RECs) set up to review clinical research through the National Research Ethics Service (NRES)

8. Social Care Research Ethics Committee (SCREC) part of NRES - set up to review social care research studies • University’s Governing Body discharged by the University Ethics Committee via the three Faculty Ethics Committees

9. How are they accessed? • Home Office Licence Contact the CBC/Faculty Office • National Research Ethics Service (NRES) • http://www.nres.nhs.uk Submission through the IRAS portal https://www.myresearchproject.org.uk/

10. Social Care Research Ethics Committee (SCREC) • http://www.screc.org.uk/ • University Faculty Research & Innovation Office http://www.ncl.ac.uk/res/research/ethics_governance/ethics/index.htm FMSEthics@ncl.ac.uk

19. Hints and Tips • Must have a clearly defined proposal – with academic/scientific review - check whether ethics is already in place! • Must have good documentation • Must carry out a risk assessment • Must allow enough time – the process will be iterative

20. Hints and Tips • Common documentation required: • Information sheet(s) • Consent form • Debriefing sheet(s) • Contact points • Questionnaires • Pictures of equipment • Advertisements • Web- interface

21. Good Documentation • Spelling and grammar • Consistent information • Accessible information • Jargon-free

22. Good documentation • Have spelling and grammatical problems been avoided? Particularly in the consent and/or participant information sheets • Is the information consistent across the whole application? Eg the consent sheet and application text • Will potential participants understand the aims and methods of the study? • Is unnecessary jargon and technical detail used? Or have they been explained?

23. R&D Approval • For clinical studies: • The NHS organisation will also require R&D Approval! • http://www.newcastle-hospitals.org.uk/about-us/staff-information_research-development.aspx • www.newcastlejro.org.uk

30. Getting Ethical Review • Submit documentation • -NRES – the Committee will meet and consider, if invited please attend! • -Home Office – the Newcastle Committee will meet and consider • -FMS Ethics – selects Reviewers to comment • Almost always there will be issues to address and respond to!

31. Once issues are resolved: • Letter to confirm ethical opinion – specific project and period • Subsequent changes/issues • amendments MUST be notified • adverse incidents MUST be reported

32. Help and advice? • Project supervisor • Research team • Faculty Research & Innovation Office (3rd floor Leech) • Joint Research Office (Governance Manager for clinical research) (Leazes Wing RVI by CRF) • The web

33. For further guidance ask: • Lois Neal, FMS Research & Innovation Office • lois.neal@ncl.ac.uk • University applications forms send to: • FMSethics@ncl.ac.uk