Ethical Approval – where to start!
February 2016
Niall O’Loughlin
University Research Office
Content
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Peer review
What are ethics and why they are important
Does my project need ethical approval?
What the key risk factors to look out for are
The Ethical review processes & Committees
- Faculty / School of Psychology
- NRES (NHS)
- AWERB (Animals)
• What you need to do
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)
(b)
an activity that will yield data
analyses that fit the data
Altogether you have a project outline (or proposal)
Peer Review
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!
Ask those with expertise and experience to evaluate it, get it
“peer reviewed”
Who? Fellow Student, Project Supervisors, Degree
Programme Directors, Academic staff (internal & external)
What are ethics (1)?
Everyday ethics – Morals
- Norms of behaviour / conduct
- Acceptable and unacceptable behaviours
Professional Context
• Rules, guidance (codes of good practice) and laws
(Law and ethics are not quite the same thing)
• Professional norms
• Personal ethics
You have ethical responsibilities to your colleagues, to yourself (wellbeing and
safety) as well as to participants.
Why are ethics important?
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Promote the aims of the research
Promote values essential to collaborative work
Accountability to the public
Public support for research
Ensure the potential benefits are worth the risks
Lead to better science through adoption of best
practice
Acting unethically can have a detrimental effect on
the participants, the researchers and the University.
Does my project need ethical approval?
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All proposals considered against a
series of triggers
Involving animals?
Involving NHS patients?
Carried out beyond the EU?
etc……
Key Risk Area 1 – Humans
• Ensuring peoples ongoing physical and mental wellbeing, and the
wellbeing of their significant others through protection of “rights, dignity,
safety and wellbeing”
- Includes living and dead
- Whole and part
- Corporeal and ethereal
- Clinical and non-clinical research
• Three principles
- Non-maleficence & Beneficence
- Autonomy
- Justice
Key Risk Areas 1 – Humans (2)
The NHS
- Does the study involve patients, their tissues or
their dependents?
- Use of NHS facilities (clinical or laboratory)
- Social care facilities or users and their families
- Anyone lacking capacity to give informed consent
- Clinical trails
High risk areas – go to NHS REC for approval
Key Risk Areas 1 – Humans (3)
Non-Clinical Setting
• Vulnerable adults, those in unequal relationships
• Those accessed through another person or organisation
• Studies involving misdirection or lack of consent
• Sensitive topics e.g. sexuality / drug use
• Involving administering drugs or other substances (food)
• Any invasive or harmful procedures
• Harm; Physical or psychological
• Significant financial inducement
High risk areas – go to Faculty Research Committee
Risk Area 2 – Animals
Animals: Defined as so under the Scientific Procedures Act
1986 i.e. live vertebrates (excluding man), including embryos
after half way through gestation, and cephalopods
Why?
- Capable of feeling pain
- Incapable of advocating for their own welfare
Includes:
- Observation, manipulation and capture as well as
experimentation.
High risk areas - go to AWERB (Animal Welfare Ethical Review
Board)
Risk Area 3 – Data
• Usage, creation or transfer of sensitive data
• Includes;
- Sensitive personal data (DPA 1998)
- Data governed by statute (OSA 1989)
- Commercial Contract
- Convention e.g. client confidentiality
- Data transferred outside EEA
High risk areas – go to Faculty Research Committee
Risk Area 4 – Environment
• Damage to the environment
• Includes;
- Emissions above the permissible UK levels
- Damage caused by sampling or fieldwork
- Detrimental effect on the landscape, includes
monuments, artefacts and cultural heritage
- Any work taking place in a area of special
scientific interest
High risk areas – go to Faculty Research Committee
Risk Area 5 – International
Work taking place outside the European
Economic Area (EU + Norway, Iceland and
Liechtenstein)
• Some funders (ESRC) consider this work to be
intrinsically more risky
High risk areas – go to Faculty Research Committee
Risk Area Six – Other Considerations
Researcher Safety
• Involves going into dangerous / unstable situations
• Involves the handling or manipulation of dangerous
substances
• Involves work outside of a researchers core
competence area
• Research funder
• Research aims are at odds with the University's ethos
Conflicts of Interest
• Funding, existing relationships
The University Process - Underlying
Principles
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Common approach across disciplines
Applies to ALL research (and other activities)
Takes place after discipline peer review
Supports approval from the right authority
• Based on the ESRC Framework for research ethics
http://www.ncl.ac.uk/res/research/ethics_governance/index.htm
http://www.ncl.ac.uk/res/research/ethics_governance/ethics_procedures/
ethical-review-process/index.htm
http://newcastle-ethics.limequery.com/index.php/survey/index/sid/865378/newtest/Y/lang/en
The University’s electronic form includes preliminary questions that relate to both
ethical review and governance matters. The sections are:
• Project Details
• Existing Ethics, Sponsorship & Responsibility
• Animals (I)
• NHS, Health & Social Care: Facilities, Staff & Patients (I)
• Human Participants in a Non-Clinical Setting (I)
• Data (I)
• Environment (I)
• International Projects (I)
If there are any non NHS “risks” then additional sections will pop up later in the form
The additional information standard sections include:
• Project Outline & Proposed Research Methods
• Permissions
• Risk Considerations & Insurance
All other sections are ‘risk’ dependent.
When is there a “gate keeper”?
When you need access via someone with undue influence
Users of a service
Members of a charity
Pupils in a class
Employees in a company
Students in your module group
Owners of Council allotments
Outcome
Already have approval or nothing triggered:
No further formal ethical review required
Something triggered:
Further formal ethical review is required (& except
for NHS risks) the form prompts for relevant further
information and sends this direct to the appropriate
committee for review.
Ethics Outcomes 2014/2015
Risk Areas
Outcome
University
FMS
NHS, Health & Social
Care
Full ethical review to be submitted
through NHS (NHS REC) approval
route
11%
21.5%
Humans in a non
clinical setting, data,
environment,
international
Full ethical review to be submitted
to Faculty ethics committed
14.5%
9%
Animals*
Full ethical review to be submitted
to Animal Welfare Ethical Review
Board (AWERB)
<0.5%
<1%
No high risk flags
No further ethical review needed
60.5%
43%
Already obtained*
No further ethical review needed
13.5%
25.5%
NHS Research Ethics Committees (RECs)
NU - Animal Welfare Ethics
Review Board
Which Authority?
Social Care Research Ethics
Committees (SCRECs)
NU - Animal Welfare Ethical
Review Board
The University
via the Faculty’s Research Ethical Review Committee
http://www.ncl.ac.uk/res/research/ethics_governance/ethics/index.htm
NHS Approvals & IRAS/
Integrated Research Application System. Run by HRA and includes NHS REC
review AND assessment of regulatory compliance
Getting Ethical Review and Approval
Submit documentation…..
• -NRES – the Committee will meet and consider, if
invited please attend!
• -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!
And finally……..
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
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amendments MUST be notified
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adverse incidents MUST be reported
Help & Advice
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The web
Project supervisor
Research team
Fellow students
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Faculty Research & Innovation Office (fmsethics@ncl.ac.uk)
University Research Office (res.policy@ncl.ac.uk)
Joint Research Office (trust.r&d@nuth.nhs.uk)
Frequently asked questions about applications to the
Faculty committee for human non-clinical research
How long does it take to get approval?
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
What information do I need to include in my
application?
How can I make the approval process go smoothly?
Some details of my protocol are not decided yet, or
may change. What should I do?
What proof of ethical approval can I send to journal
editors?
E-mail response:
SAVE this as a text document
Research Office can provide a letter as well if need be
My project did not trigger any flag questions. Can I now
do what I want?
When does thinking about ethics and care of
participants finish?
How should I deal with an adverse event or a
complaint?
The ethics committee is here to assure Newcastle
University’s integrity and reputation and help you do
successful research!