1. Ethics Training Niall O’Loughlin Policy & Information Officer, RES (res.policy@ncl.ac.uk)res.policy@ncl.ac.uk

2. Content What are ethics and why they are important What the key risk factors to look out for are The ethical review processes and committees; - Faculty - NRES (NHS) - AWERB (Animals) What you need to do

3. 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 Professional norms Personal ethics You have ethical responsibilities to your colleagues, to yourself (wellbeing and safety) as well as to participants.

4. Why are ethics important? General 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.

5. Which Projects and for what purpose? All research projects Consultancy....and more! The purpose of the ethics process is to: 1.Identify any high risk projects 2.Ensure that any risks are minimised and /or managed in line with the best scientific practice in the field. All done through the online form and review process.

6. Risks and Review Committees Risk AreasOutcome% NHS, Health & Social Care – high risk flags Full ethical review to be submitted through NHS (NHS REC) approval route 10 Humans in a non clinical setting, data, environment, international – high risk flags Full ethical review to be submitted to Faculty ethics committed 16 Animals – high risk flagsFull ethical review to be submitted to Animal Welfare Ethical Review Board (AWERB) 3 No high risk flagsNo further ethical review needed55 Already obtainedNo further ethical review needed16

7. 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

8. 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

9. 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

10. 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)

11. 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

12. 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

13. 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

14. 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

15. Stage II – Full Ethical Review For any high risk projects without approval. -Funded projects: Full ethical review must be sought at award stage and be in place before any work can begin. -Unfunded projects: Full ethical review must be sought and in place before any work can begin. All projects going to a University Committee use the online form: http://www.ncl.ac.uk/res/research/gov- ethics/ethics_procedures/ethical-review-process/index.htmhttp://www.ncl.ac.uk/res/research/gov- ethics/ethics_procedures/ethical-review-process/index.htm

16. Stage II – Full Ethical Review (Faculty) Use the University standard form. Complete the relevant sections Provide key documents e.g. consent forms Each faculty has it’s own committee 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

17. Stage II – Full Ethical Review (AWERB) Use the University standard form Complete the relevant sections Provide key documents e.g. permissions 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

18. Stage II – Full Ethical Review (NHS REC) Submission of application through HRA Portal. All documents must be uploaded along with all relevant authorisations e.g. sponsor, Chief Investigator Once application complete, telephone central booking service (0207 104 8000) to book review. Offered first available slot and average review period is 30 days (maximum 60 days). If the application receives a review by a full committee you should attend in person. Link to HRA Application Process Flowchart

19. What you need to do Consider any potential ethical issues in your project before you start work (fill in the form) Know what’s expected: from the University, from your profession, from your funder and legally. Get ethical approval in place before you begin Review: Projects change and so can ethical issues Know what’s expected: from the University, from your profession, from your funder and legally. Know who’s responsible within the project teams / and across them in the case of collaborative projects.

20. Resources Ethics Toolkit: http://www.ncl.ac.uk/res/research/ethics_governance/eth ics_governance_toolkit/index.htm Sections on; working with participants (consent, confidentiality and culpability), animals, example consent forms, risk and safety, data, funders etc. http://www.ncl.ac.uk/res/research/ethics_governance/eth ics_governance_toolkit/index.htm Training and Support Internal: Is provided on request, either to groups or one on one. Requested through URO / Faculty. External: AREC, Clinical Research Networks (Trust Staff) etc.

21. Contacts Faculty Ethics Committees - FMS: Lois Neal (lois.neal@ncl.ac.uk)lois.neal@ncl.ac.uk - SAgE: Louise Jones (louise.jones@ncl.ac.uk)louise.jones@ncl.ac.uk - HASS: Lorna Taylor (lorna.taylor@ncl.ac.uk)lorna.taylor@ncl.ac.uk AWERB: Paul Dearden (paul.dearden@ncl.ac.uk)paul.dearden@ncl.ac.uk NHS (at NUTH): trust.r&d@nuth.nhs.uktrust.r&d@nuth.nhs.uk Central: Niall O’Loughlin (res.policy@ncl.ac.uk)res.policy@ncl.ac.uk

22. Questions ?