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_gov ernance/ethics/procedures/staff_review.htm Retain the form with your protocol!

6. Preliminary Ethical Assessment Stage 1 To find out: a)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 Universitys 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_gove rnance/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 (3 rd 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