Which Projects need Ethical Review?
Newcastle University requires that the online ethics form is submitted for all projects before any work begins. This includes research, consultancy and teaching projects, whether the principal investigator is a student or staff member, and whether the project is funded or unfunded.
Projects that are considered as high risk by Newcastle University will require formal ethics review by a Research Ethics Committee.
The procedure is as follows:
Step 1: the principal investigator completes Newcastle University's online ethics form. The form is made up of a series of questions, which aim to help the principal investigator identify whether the project is 'high risk' and requires further formal ethical review by a Research Ethics Committee.
Step 2: once the form is completed and submitted, the principal investigator will receive a notification that either:
- based on the answers provided, the University is satisfied that the project meets the University's ethical expectations and grants the project ethical approval
- based on the answers provided, the project requires further review by a Research Ethics Committee before any research can begin
The online ethics form must be completed as accurately as possible, but acts only as a guide to facilitate the ethics management process. Ultimately, the principal investigator is responsible for ensuring their research satisfies Newcastle University's ethical expectations, and has been subject to the appropriate level of ethical review. If the principal investigator thinks that the form has incorrectly identified their project as low risk, they should contact res.policy@ncl.ac.uk, before commencing any project work.
What is considered high risk?
Newcastle University considers high risk research to be research that poses (or has the potential to pose) more than minimal risk.
In particular, research involving any of the following is considered high risk:
- protected animals (as defined by ASPA)
- NHS/Health and Social Care users and/or facilities
- human participants and
- vulnerable groups including, for example, children
- the use of a gatekeeper
- participant deception
- administration of drugs, placebos or other substances
- invasive, intrusive or potentially harmful procedures
- pain or more than mild discomfort
- psychological stress, anxiety, harm or negative consequences beyond that encountered in normal life
- prolonged or repetitive testing
- financial inducements
- relevant material including, for example, blood
- sensitive data and/or the collection/use of personal data without consent
- (potential) harm to the environment
- work undertaken outside of the European Economic Area (EEA)
Other factors
Sometimes a project is high risk due to other factors including, for example:
- conflicts of interest
- the origin of the research funding
- non-standard experimental design
- societal impacts
- benefits/risks are not clear
The principal investigator is responsible for ensuring their research satisfies Newcastle University's ethical expectations and has been subject to the appropriate level of ethical review. Where a project involves additional factors that could cause the project to pose more than minimal risk (such as those listed above), the researcher must ensure their project undergoes formal ethical review from a Research Ethics Committee. Please contact res.policy@ncl.ac.uk for guidance.
External ethical approval
Newcastle University may accept ethical approvals granted by external reviewers, if all of the following are met:
- the external review meets Newcastle University's ethics and governance standards
- the scope of the external review is consistent with Newcastle University's ethics policy
- the Faculty Ethics Representative agrees to accept the existing approval in lieu of a new Newcastle University ethics application
Please see Ethics Toolkit - External Ethical Approval for more information.
Note, where the project has received approval from an NHS/HSC Research Ethics Committee, Newcastle University will accept the approval and there is no need for the researcher to contact their Faculty Ethics Representative.
Proportion of projects for each ethics outcome
| Risk areas | Outcome | % |
|---|---|---|
| NHS, Health & Social Care | Ethical review by NHS/HSC Research Ethics Committee required | 1 |
| Human participants, data, environment, international – high risk research | Ethical review by a University Faculty Ethics Committee required | 16 |
| Protected animals | Ethical review by the Animal Welfare Ethical Review Board (AWERB) required | 4 |
| Not high risk | No further ethical review required | 72 |
| Ethical approval already acquired | No further ethical review required | 7 |