Post on 17-Jan-2016
Ethical Approval – where to start!
October 2015 – February 2016
Lois Neal
FMS Research & Innovation Office
Do I need ethical approval to do this?
?
You already have:
… a clearly defined research questionand 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)
Need anything else?
The answer to…
Will my proposed project actually work?
You’ll get stopped in your tracks without an answer!
Will my proposed project actually work?
Of course it will!Hopefully, it will It’ll be trial and error, I guessI’ve no idea, really!
I’ll get it “peer reviewed”I’ll ask those with expertise and experience
Who does this “peer review”?
• Your peers!• Project supervisor• Programme Director• Principal Investigator• Head /staff of academic unit• Experts from other HEIs
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!
Gate questions……………………Answer “yes” or “no”
If “no”, skip to the next gate question……If “yes”, stay and answer the sub-questions……
If these are ALL “no” nothing has been triggeredGo 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 reviewYou have ethical approval to proceed
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
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…..
When is there a “gate keeper”?When you need access via someone with undue influence
Pupils in a class
Employees in a companyStudents in your module group
Members of a charity
Owners of Council allotments
Users of a service
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 reviewand approval
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
Further ethical review
Where from?The appropriate “recognised authority”
What are these “recognised authorities”?How do I ask for ethical review and approval?
NU - Animal Welfare Ethics Review Board
Which Authority?
NHS Research Ethics Committees (RECs)
Social Care Research Ethics Committees (SCRECs)
NU - Animal Welfare Ethical Review Board
Contact the CBC/Faculty Office
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)
HRA provides:
a new process comprises a review by a NHS RECANDassessment of regulatory compliance
Introduction is phased!
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)
The University via the Faculty’s Research Ethical Review Committeehttp://www.ncl.ac.uk/res/research/ethics_governance/ethics/index.htm
Submission of application via FMSEthics@ncl.ac.uk
Notes for NHS REC Approval
Best advice:
Use the Web!
and
talk to someone with experience of the process
Newcastle focussed information
Our NJRO
“R&D Approval”
“R&D Approval” Check-list
National information (from NIHR)
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!
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……..
For further guidance ask:
Lois Neal, FMS Research & Innovation Office
lois.neal@ncl.ac.uk
University applications forms send to:
FMSethics@ncl.ac.uk
Stage 2 – Full Ethical Review
Stage 2 Form
Putting an application together……
Hints and tips………
Perfect preparation prevents poor performance
Give yourself enough time
More Hints and Tips
Full explanationsEasy to readGood standard of EnglishCorrect spellingsJargon free
Reviewers are new to your proposal……
be kind to themlead them through what you want to do
What do I include?
Aim of my studySummary of what I’m going to doWho I want to participateNumber of participants I needHow I’m going to invite them to participate
How I’ve minimised the risks
What do I include?
How I’m going to ensure informed consent
• Information sheet(s)
How I’m going to ensure confidentialityHow I’m going to ensure anonymity
• Consent form
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
Giving information
Would a picture help?
Does it look like a “clinical” procedure?
Is it on-line or face-to-face?
Is it to be a focus group discussion?
How’s it be measured?
A sample of what? How?
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
Stage 2 Form
Information
Consent
Thank you
Risk mitigation – 1 of 2
Risk mitigation – 2 of 2
Participant facing documents
Check-list:
Newcastle University logo/headed note-paperName/logo of research funderName & contact details of researcherName & contact details of PI/Supervisor
whether on paper or electronic
What else do I include?
• Questionnairesplus confirmation of viability or publication
• Pictures of equipment • Advertisements• Web- interface
One More Hint/Tip
Allow enough time to put the application togetherto get it checked by supervisorto get it “sense checked”
BEFORE it is submitted!!
Be aware, once submitted– the review process will be iterative
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……..
Help and advice?
• The web• Project supervisor• Research team• Fellow students
• Faculty Research & Innovation Office (3rd floor Leech)
• Joint Research Office (Governance Manager for clinical research)
(Leazes Wing RVI by CRF)
For further guidance ask:
Lois Neal, FMS Research & Innovation Office
lois.neal@ncl.ac.uk
University applications forms send to:
FMSethics@ncl.ac.uk