1. Ethics Overview Policy & Information Team
Research & Enterprise Services
Duration 30 mins
Housekeeping
Questions throughout – however sessions will cover the basics
Session is a broad based intro

2. Session Overview Ethics at Newcastle Ethical review - Risk factors
Why ethics is important
Your role in the ethics process
Ethical review - Risk factors
Key Risks (People, Animals, other)
What you need to do
Process, Forms and Systems

3. Ethics at Newcastle What is ‘Ethics’ at Newcastle?
Open to interpretation.
Based around professional ethics.
Ensures activity is as beneficial as possible for all involved.
Why is ethics important?
Maximise the benefit and minimise any harm caused (example of bad practice – Parexel and TGN1412).
Who does ethics apply to?
Everybody! Staff, Students and others representing us.
What projects does it apply to?
Research.
Teaching & learning.
Consultancy.
Other external work.
Ethics is open to interpretation but it generally a set of moral principles.
Ethics at Newcastle focuses more on professional ethics.
Researchers have ethical responsibilities to your colleagues, to yourself (wellbeing and safety) as well as to participants
Acting unethically can have a detrimental effect on the participants, the researchers and the University.
TGN 1412 (trial autoimmune diseases drug) a phase 1 clinical trial conducted in 2006 by Parexel, an independent clinical trials unit based in London £2000 paid to healthy volunteers, who were given the drug within the span of 1 hr of each other. All ended up in hospital, 1 ended up in a coma and suffered multi-organ failure. Company failed to follow many rules that have since been made standard in Europe.
Funders require that the university ensure the ethics and governance if any work it sponsors. Misconduct a dismissible offence.

4. Ethical Review – Risk Areas
1. NHS Services
Using patients or facilities.
2. Animals
Capturing or observing protected animals.
3. Human Participation (Non-Clinical)
Issuing surveys, taking blood, administering drugs.
4. Data
Collecting sensitive data.
5. Environment
Harmful to the environment, damage to heritage site.
6. International
Working outside the European Economic Area (EEA).
Risk Hierarchy; anything NHS goes to NREC they will consider other risks. Same applies to Animals. Risk 3 – 6 will be considered by faculty.

5. Ethical Review - 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.

6. What you need to do - Process
Flagged as
NHS Project
Flagged as
NHS Project
Integrated Research Application Service
The purpose of the ethics process is to:
Ensure the project is undertaken and /or managed in line with the best scientific practice in the field
Identify any high risk projects
Minimise risk
Start point depends on the type of project: e.g. funded or unfunded (students)
All done through the online form and review process.

7. What you need to do – Forms & Systems (University Ethics Form)
Accessed via: Ethics Web Pages

8. What you need to do – Forms & Systems (MyProjects Proposals)
Risk Areas & Initial Qs
the same in
MyProjects Proposals & Ethics form

9. Ethical Review – Committee Review
NHS Resarch Ethics Committee (REC)
Submission through Health Research Authority (HRA) Portal (Integrated Research Application Service) HRA Process
Animal Welfare Ethics Review Board (AWERB)
AWERB serves all faculties and meets monthly.
Reviewed by whole committee signed off by Chair.
Applicants will generally receive a decision and / or recommendations within two weeks of the meeting.
Faculty
All committees meet virtually
Reviewed by one/two members and signed off by Chair
Applicants will generally receive a decision and/or recommendations within 20 working days

10. Ethical Review – Gatekeepers & Sponsors
Person or institution acting as intermediary between researcher and potential participants. May have power to grant access to potential participants
Examples: Health and Social Care professionals working with patients, children or elderly.
Sponsorship
Some projects with the NHS means the University takes responsibility for the overall governance, monitoring and management of the proposed research.
More information can be found here: Sponsorship
Researchers must describe their recruitment strategy within the research protocol and give full consideration as to whether there is a need for a gatekeeper or not.
May not be mandatory but good etiquette to use a gatekeeper
University Recruitment Pools
The University has two generic volunteer pools. These are made up of people (including members of the public and students)  who have expressed an interest in being research participants and to being contacted by researchers with participant opportunities. Although these pools are ‘gatekeepers’ in the strictest definition, because the participants can opt in or out of any project they are NOT CLASSED as gatekeepers for the purpose of the University ethics form. The two pools are:
School of Psychology Volunteer Pool
The School of Psychology volunteer pool consists of Undergraduate Psychology students and the participants have opted into being contacted by other psychology students for the purposes of their research projects.
Institute of Neuroscience Volunteer Pool
The Institute of Neuroscience volunteer pool consists of members of the public. These individuals are generally people who have been research participants in the past and who have agreed to be contacted with future participant opportunities.

11. Ethical Review – Key Points
Application forms
Answering “Yes” to initial questions does not necessarily mean full review.
You, as PI, are responsible for your ethics application.
All projects (funded or unfunded) need to go through the University’s ethics application form.*
Committee Review (High Risk projects)
Ethics committees will rarely so “no” outright.
Different committees have different timescales.
*Excludes NHS projects identified as high risk in MyProjects Proposals

12. Summary Consider ethical issues before submitting your application.
Know what’s expected from the University, your profession, your funder and the law.
Ethical approval needs to be in place before work begins.
Projects can change – changes may need new ethics.

13. Resources
Ethics Toolkit: Participants - Consent, Confidentiality and Culpability
Animals - 3 R-principles (Reduction, Refinement, Replacement)
Template documents - e.g. consent forms
Risk and safety
Funder guidance
Training and Support: Internal:
Policy & Information Team
Faculty Reps External:
European Network of Research Ethics Committees (EUREC)
Funding Bodies
Health Research Authority (HRA)

14. Contacts
Faculties FMS: Kimberley Sutherland SAgE: Rachel Collum HASS: Wendy Davison Animal Research AWERB: David Baird NHS Research NHS (at NUTH): Research Office Policy & Information Team:
Who can help

15. Questions ?