ethics – where to start!
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Ethics – where to start!. October 2012 Lois Neal FMS Research & Innovation Office. 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. - PowerPoint PPT PresentationTRANSCRIPT
Ethics – where to start!
October 2012
Lois Neal
FMS Research & Innovation Office
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
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
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!
Preliminary Ethical Assessment Stage 1
To find out:
a) Is formal ethical review needed?
If needed,
b) Which authority should it come from?
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)
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
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/
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
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
Hints and Tips
Common documentation required:
Information sheet(s)
Consent form
Debriefing sheet(s)
Contact points
Questionnaires
Pictures of equipment
Advertisements
Web- interface
Good Documentation
Spelling and grammar
Consistent information
Accessible information
Jargon-free
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?
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
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!
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
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
Lois Neal
FMS Research & Innovation Office
Patrick Oliver
Secretary to FMS Ethics Committee