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Ethics Overview

Ethics Overview. Policy & Information Team Research & Enterprise Services ( res.policy@ncl.ac.uk ). Session Overview. Ethics at Newcastle Why ethics is important Your role in the ethics process Ethical review - Risk factors Key Risks (People, Animals, other) What you need to do

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Ethics Overview

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

  2. Session Overview • Ethics at Newcastle • 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.

  4. Ethical Review – Risk Areas 1. NHS Services • Using patientsor 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).

  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

  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 Gatekeepers • 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

  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 beforework 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 RepsExternal: European Network of Research Ethics Committees (EUREC) Funding Bodies Health Research Authority (HRA)

  14. Contacts Faculties FMS: Kimberley Sutherland (kimberley.sutherland@ncl.ac.uk) (fmsethics@ncl.ac.uk) SAgE: Rachel Collum (rachel.collum@ncl.ac.uk) (sage.ethics@ncl.ac.uk) HASS: Wendy Davison (wendy.davison@ncl.ac.uk) Animal Research AWERB: David Baird (david.baird@ncl.ac.uk) NHS Research NHS (at NUTH): trust.r&d@nuth.nhs.uk Research Office Policy & Information Team: res.policy@ncl.ac.uk

  15. Questions ?

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