Ethics Diagnostic Tool

Introduction

Northumbria University seeks to ensure that ethical standards are maintained in research by and throughout the University. Faculties, on behalf of the University, are responsible for ensuring all students and staff conducting research, and all research involving University staff, students, and premises is in accordance with the University’s ethical standards.

In order to help you determine the level of ethical scrutiny and risk for your research projects, we have devised a question and answer self-evaluation form to help your assessment and subsequently inform you about the level of ethical review required.

There are 3 levels of ethical and risk scrutiny:

RED
High risk; requires high level of scrutiny
AMBER
Medium risk; requires internal review
GREEN
Low risk; may not require internal review if compliant with Faculty governance procedures

Please refer to the Glossary of Terms if required.

Self-assessment: ethical scrutiny and risk level for your research projects

Does your research specifically involve one of the following?

  • Medicinal products
  • Clinical trial
  • Animal subjects
  • Children or vulnerable adults
  • NHS staff, patients, premises or equipment
  • Concerns around safety or discomfort for the participants or researchers
  • Sensitive subjects such as trauma
  • Data which comes under the Official Secrets Act

If YES, follow guidance for REDresult

If NO, does your research involve any of these?

  • Non-vulnerable adults
  • Personal data (i.e. primary data collected from people) referring to a living individual
  • Environmental issues
  • Commercially sensitive information
  • Pharmacologically active substance

If YES, follow guidance for AMBER result

If NO, is your research

  • completely based on secondary data which has been previously published

and/or

  • desk or lab-based and does not involve people in data collection
  • Not about a subject which may be considered sensitive?

If YES, follow guidance for GREEN result

GUIDANCE

RED
High risk; Approval must be conditional andrequires high level of scrutiny. Review internally and externally
Other considerations: indemnity arrangement, external legislations and sponsorship

What happens next?

Your project proposal will require a high level of ethical scrutiny and possible external peer review. There may also be legislative requirements to comply with eg MHRA, NHS REC, Human Tissue Act and EudraCT. Indemnity arrangements may also need to be reviewed in light of the additional risk involved.

If your Faculty Research Ethics Committee is unable to resolve the issue, the proposal should be reviewed by the University Research Ethics Committee.

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AMBER
Medium risk; Approval should be conditional. Review internally by one independent reviewer, not Faculty Research Ethics Committee
Other considerations: Informed consent and confidentiality

What happens next?

Your project proposal has some ethical implications and will be reviewed by the Faculty Research Ethics Committee. Some factors to be considered include considering obtaining informed consent forms from organisations or people involved as well as confidentiality/anonymity issues.

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GREEN
Low risk; Projects may be approved unconditionally by supervisor or equivalent, not Faculty Research Ethics Committee. May not require internal review if compliant with Faculty governance procedures
Other considerations: none

What happens next?

Your project proposal will still need to be reviewed by your Faculty Research Ethics Committee. You need to be ethically aware and ensure that you have not breached plagiarism or copyright regulations and have adequately referenced your material.

It is recommended that you refer to Northumbria University Research Ethics Policy.

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Sept 2014/RBS