Ethics Overview Policy & Information Team Research & Enterprise Services (res.policy@ncl.ac.uk)

Overview Ethics at Newcastle Ethical review - process and risk Why are they important? Your role Ethical review - process and risk Funded or unfunded? Key Risks (People, Animals, other) What you need to do Forms and Systems

Ethics at Newcastle What is ‘Ethics’ at Newcastle? Everyday and professional ethics Ensures activity is as beneficial as possible for all involved Why is it important? Maximise the benefit and minimise any harm caused by the University’s activities 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 Essentially ethics is a set of moral principals and there is a distinction between everyday and professional ethics. e.g. everyday – it is wrong to commit murder & professional - Hippocratic oath, codes of conduct (BMA) and concordat on research integrity Everyday ethics-Morals - Norms of behaviour / conduct - Acceptable and unacceptable behaviours You have ethical responsibilities to your colleagues, to yourself (wellbeing and safety) as well as to participants Professional Context Rules, guidance (codes of good practice) and laws Professional norms Personal ethics 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. Knowledge, Avoidance of error, Truth, Trust, Accountability, Respect (KATTAR) 1/3 of Universities income is directly funded by the public (through RCUK), more indirectly High quality research is value for that investment Animal testing; worth it for an anti cancer drug but maybe not for a better shampoo (banned in UK) Raising standards Funders require that the university ensure the ethics and governance if any work it sponsors. Misconduct a dismissible offence.

Ethical Review Processes - Overview

Ethical Review Process - Stage 1 - Unfunded Complete University Ethics Form: http://www.ncl.ac.uk/res/research/gov-ethics/ethics_procedures/ethical-review-process/index.htm Answering ‘Yes’ to initial question does not necessarily mean full review. Low Risk - No Further Action required (email notification). High Risk – Further review by relevant ethics committee (email notification). All details of submitted form sent to relevant contact

Ethical Review Processes - Important For identified high risk projects. 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. Projects to be reviewed by a Faculty Ethics Committee must complete the online form: http://www.ncl.ac.uk/res/research/gov-ethics/ethics_procedures/ethical-review-process/index.htm Rarely an outright No! Different committees have different timescales

Risk Area 1 – Humans (clinical) Covers anyone in the care of the NHS or Social Care System. Patients alive or recently deceased (including those treated under contracts with private sector providers; Patients Foetal material and in vitro fertilisation involving NHS patients; The recent dead in NHS premises (i.e. post mortem material); Access to and/or use of any records relating to past or present NHS patients; Human subjects including healthy volunteers where the research may harm their physical or mental health. Research on tissue samples derived from NHS patients or from participants in trials involving the NHS. (The latter is to cover healthy volunteer studies or controls within studies running through the NHS) High Risk on Ethics form? NHS REC approval

Risk Areas 2 – Humans (non-clinical) Questions: Will vulnerable groups be involved? Will gatekeepers be used? Will misdirection or lack of consent be utilised? Will sensitive topics (e.g. sexuality/drug use) be studied? Will drugs or other substances (food) be administered? Will any invasive or harmful procedures be use? Will harm (physical or psychological) be experienced? Will there be significant financial inducement? High Risk on Ethics form? Faculty Committee Approval

Risk Area 3 - Animals Animals Scientific Procedures Act (ASPA)1986 defines animals as: live vertebrates (excluding man), including embryos after half way through gestation, and cephalopods. - Capable of feeling pain and - Incapable of advocating for their own welfare University is committed to the 3Rs: Replacement - avoiding or replacing the use of animals Reduction - minimise the number of animals used Refinement - minimise suffering and improve animal welfare

Risk Area 3 - Animals Cont’d… Questions: Will you experiment on animals? Will you observe, manipulate or capture animals? High Risk on ethics form? AWERB

Risk Area 4 - Data Questions : Will you use, create or transfer of sensitive data? Will you collect sensitive personal data (DPA 1998)? Will you collect data governed by statute (OSA 1989)? Will the data relate to Commercial Contract (Licensing)? Will the data include convention (client confidentiality – non disclosure agreement)? Will the data be transferred outside EEA? High Risk on ethics form? Faculty Research Committee.

Risk Area 5 - Environment Questions: Will the research damage the environment? Will emissions be above the permissible UK levels? Will damage be caused by sampling or fieldwork? Will there be a detrimental effect on the landscape (including monuments, artefacts and cultural heritage)? Will research take place in a area of special scientific interest? High Risk on ethics form? Faculty Ethics Committee

Risk Area 6 - International Questions: Will research take place outside the European Economic Area (EU + Norway, Iceland and Liechtenstein)? Issues: Some funders (ESRC) consider this research increases risk Research carried out in Singapore and Malaysia can be classed as local for the purposes of Ethics. High Risk on Ethics form? Faculty Ethics Committee ESRC requirement “not intrinsically more risky” but more risk to researcher. Few interesting cases where UK norms clash with local custom / standards.

Other Risk 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

Risks and Review Committees - update Ethics Submitted 2015-2016 Risk Areas Outcome % NHS, Health & Social Care – high risk flags Full ethical review to be submitted through NHS (NHS REC) approval route 2 Humans in a non clinical setting, data, environment, international – high risk flags Full ethical review to be submitted to Faculty ethics committed 17 Animals – high risk flags Full ethical review to be submitted to Animal Welfare Ethical Review Board (AWERB) 3 No high risk flags No further ethical review needed 76 Already obtained

Ethics Overview Break Questions so far?

Full Ethical Review (NHS REC) Submission of application through HRA Portal (IRAS) 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

Full Ethical Review (AWERB) Complete all sections of the University Ethics Form. 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.

Full Ethical Review (Faculty) Complete all sections of the University Ethics Form 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

Summary Consider any potential ethical issues in your project before you start work. 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. Get ethical approval in place before you begin. Review: Projects change and so can ethical issues.

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

Contacts Faculty Ethics Committees - FMS: Kimberley Sutherland(lois.neal@ncl.ac.uk) - SAgE: Rachel Collum(louise.jones@ncl.ac.uk) - HASS: Lorna Taylor (lorna.taylor@ncl.ac.uk) AWERB: Paul Dearden (paul.dearden@ncl.ac.uk) NHS (at NUTH): trust.r&d@nuth.nhs.uk Central: res.policy@ncl.ac.uk

Questions ?