Ethical Approval – where to start! February 2016 Niall O’Loughlin University Research Office

Content 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)an activity that will yield data (b)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? 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? ?

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 Hi gh 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 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

ethical-review-process/index.htm

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 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

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 AreasOutcomeUniversityFMS 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 flagsNo further ethical review needed60.5%43% Already obtained*No further ethical review needed13.5%25.5%

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

The University via the Faculty’s Research Ethical Review Committee

NHS Approvals & IRAS/ Integrated Research Application System. Run by HRA and includes NHS REC review AND assessment of regulatory compliance

Our NJRO

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!

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 & Advice The web Project supervisor Research team Fellow students Faculty Research & Innovation Office University Research Office Joint Research Office

Frequently asked questions about applications to the Faculty committee for human non-clinical research

How long does it take to get approval?

What information do I need to include in my application? 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

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?

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!