1. Ethical Approval – where to start! October 2015 – February 2016 Lois Neal FMS Research & Innovation Office

2. Do I need ethical approval to do this? ?

3. You already have: … a clearly defined research question and a route to getting an answer You know what you’re actually going to do (a)an activity that will yield data (b)analyses that fit the data Altogether you have a project outline (or proposal)

4. Need anything else? The answer to… Will my proposed project actually work? You’ll get stopped in your tracks without an answer!

5. Will my proposed project actually work? Of course it will! Hopefully, it will It’ll be trial and error, I guess I’ve no idea, really! I’ll get it “peer reviewed” I’ll ask those with expertise and experience

6. Who does this “peer review”? Your peers! Project supervisor Programme Director Principal Investigator Head /staff of academic unit Experts from other HEIs

7. Now……….ethics! Give your proposal a preliminary ethical review (a preliminary assessment of the risks involved) Who is responsible? Who carries out this review? Who needs to know about it? Who is in a position to check it? Who keeps the record of it? You are in charge here!

8. Gate questions…………………… Answer “yes” or “no”

9. If “no”, skip to the next gate question…… If “yes”, stay and answer the sub-questions…… If these are ALL “no” nothing has been triggered Go on to the next gate question…… If ALL the gate questions are answered “no”….. Or if ALL the sub-questions are answered “no”….. You do not need any further ethical review You have ethical approval to proceed

10. Examples Further analysis of existing anonymous data Review of experiments carried out and reported by others Student feedback of teaching Market research Internal review of a process to improve it Randomised public opinion poll

11. If “no”, skip to the next gate question…… If “yes”, stay and answer the sub-questions…… If one or more is “yes”, then a risk has been triggered Watch out for the “gate keeper” question…..

12. When is there a “gate keeper”? When you need access via someone with undue influence Pupils in a class Employees in a company Students in your module group Members of a charity Owners of Council allotments Users of a service

13. If “no”, skip to the next gate question…… If “yes”, stay and answer the sub-questions…… If one or more of these is “yes”, then a risk has been triggered You will need to give further details (further questions will pop up) for further review and approval

14. Examples A survey of children or vulnerable adults One-to-one interviews about sensitive topics Reaction-time tests of people with Alzheimer's Disease Collecting diet or exercise diaries and determining BMIs Measuring TV watching in adolescents Targeted questionnaires delivered over the web

15. Further ethical review Where from? The appropriate “recognised authority” What are these “recognised authorities”? How do I ask for ethical review and approval?

16. NU - Animal Welfare Ethics Review Board Which Authority? NHS Research Ethics Committees (RECs) Social Care Research Ethics Committees (SCRECs)

17. NU - Animal Welfare Ethical Review Board Contact the CBC/Faculty Office

18. National Research Ethics Service (NRES) Social Care Research Ethics Committee (SCREC) 2015 - The submission and approval processes are moving to the Health Research Authority (HRA) NHS Research Ethics Committees (RECs) Social Care Research Ethics Committees (SCRECs)

19. http://www.hra.nhs.uk/

20. HRA provides: a new process comprises a review by a NHS REC AND assessment of regulatory compliance Introduction is phased!

21. From 10 August 2015 Studies that fit: (1)Health services research studies involving only NHS staff as participants. These must be studies that are identifying participants by virtue of their NHS employment and that do not require review by a NHS Research Ethics Committee (REC) (2)Studies that are taking place only in a primary care independent contractor setting in the NHS in England. This includes NHS GP practices, dental practices and community pharmacies. This would not include studies that are taking place in a secondary care or mental health setting in the NHS. And satisfy: Be taking place in England only. Not be solely undertaken for educational purposes. Be multi-site or single site (except where the single site is also sponsor)

23. The University via the Faculty’s Research Ethical Review Committee http://www.ncl.ac.uk/res/research/ethics_governance/ethics/index.htm Submission of application via FMSEthics@ncl.ac.uk

25. Notes for NHS REC Approval Best advice: Use the Web! and talk to someone with experience of the process

26. Newcastle focussed information

27. Our NJRO

29. “R&D Approval”

31. “R&D Approval” Check-list

32. National information (from NIHR)

34. Getting Ethical Review and Approval Submit documentation….. -NRES – the Committee will meet and consider, if invited please attend! (Proportionate Review also offered now) -AWERB/Home Office – Newcastle Committee will meet and consider -FMS Ethics – selected Reviewers comment (Virtual Committee) Almost always there will be issues or comments to address and respond to!

35. Once ALL issues are resolved: Letter to confirm ethical opinion, if favourable, then you have ethical approval Letter is for a specific project and period Subsequent changes/issues amendments MUST be notified adverse incidents MUST be reported And finally……..

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

38. Stage 2 – Full Ethical Review

40. Stage 2 Form

41. Putting an application together…… Hints and tips……… Perfect preparation prevents poor performance Give yourself enough time

42. More Hints and Tips Full explanations Easy to read Good standard of English Correct spellings Jargon free Reviewers are new to your proposal…… be kind to them lead them through what you want to do

43. What do I include? Aim of my study Summary of what I’m going to do Who I want to participate Number of participants I need How I’m going to invite them to participate How I’ve minimised the risks

44. What do I include? How I’m going to ensure informed consent Information sheet(s) How I’m going to ensure confidentiality How I’m going to ensure anonymity Consent form

45. When is opting out acceptable? I’m going for the easy option……….. Everyone’s included unless they say “No, thank you” Never ever for Newcastle research proposals

46. Giving information Would a picture help?

47. Does it look like a “clinical” procedure?

48. Is it on-line or face-to-face? Is it to be a focus group discussion?

49. How’s it be measured? A sample of what? How?

50. What do I include? How I’m going to store the data How I’m going to say “thank you” Debriefing sheet(s) How I’m going to sign post onward support Support contact details

51. Stage 2 Form

52. Information Consent Thank you Risk mitigation – 1 of 2

53. Risk mitigation – 2 of 2

54. Participant facing documents Check-list: Newcastle University logo/headed note-paper Name/logo of research funder Name & contact details of researcher Name & contact details of PI/Supervisor whether on paper or electronic

55. What else do I include? Questionnaires plus confirmation of viability or publication Pictures of equipment Advertisements Web- interface

56. One More Hint/Tip Allow enough time to put the application together to get it checked by supervisor to get it “sense checked” BEFORE it is submitted!! Be aware, once submitted – the review process will be iterative

57. Once ALL issues are resolved: Letter to confirm ethical opinion, if favourable, then you have ethical approval Letter is for a specific project and period Subsequent changes/issues amendments MUST be notified adverse incidents MUST be reported And finally……..

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

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