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Overview of ethical review processes
NOTE: All staff and students whose projects require some form of ethical review must apply for and receive ethical approval before their research may commence
WHAT DO I NEED TO DO?
All staff and students applying for 5XÉçÇøÊÓƵ ethical review are required to complete the filter checklist in Section A of the 5XÉçÇøÊÓƵ's . This filter checklist determines whether the project is low risk or higher risk.
Responsibilities for Ethical Review of Research
| A1. Will your study involve participants who are particularly vulnerable or unable to give informed consent or in a dependent position (e.g. people under 18, people with learning difficulties, over-researched groups or people in care facilities)? |
| A2. Will participants be required to take part in the study without their consent or knowledge at the time (e.g. covert observation of people in non-public places), and / or will deception of any sort be used? Please refer to the for further information. |
| A3. Will it be possible to link personal data back to individual participants in any way? (this does not include identifying participants from signed consent forms or identity encryption spreadsheets that are stored securely separate from research data). |
| A4. Might the study induce psychological stress or anxiety, or produce humiliation or cause harm or negative consequences beyond the risks encountered in the everyday life of the participants? |
| A5. Will the study involve discussion of sensitive topics (e.g. sexual activity, drug use, ethnicity, political behaviour, potentially illegal activities)? |
| A6. Will any drugs, placebos or other substances (such as food substances or vitamins) be administered as part of this study and will any invasive or potentially harmful procedures of any kind will be used? |
| A7. Will your project involve working with any substances and / or equipment which may be considered hazardous? |
| A8. Will your study involve the taking and/or storage of human tissue that falls under the Human Tissue Act (HTA)? |
| A9. Will financial inducements (other than reasonable expenses, compensation for time or a lottery / draw ticket) be offered to participants? |
Low Risk Projects:
If you are able to answer 'No' to all nine questions in the checklist, then the project is assumed to be low risk. You will then be provided with SECTION B of the application form and you should submit this (along with supporting documents) for low-risk review:
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- UG and PGT students apply for LOW-RISK REVIEW through your School's ethical review process (SREO).
- Staff and PGR students apply for LOW-RISK REVIEW to your School's C-REC.
Higher Risk Projects:
If you are unable to answer 'No' to all nine questions in the checklist, then your project is regarded as being higher risk. The online application system will present you with SECTION C of the application form and you should submit this (along with supporting documents) to your School's C-REC for HIGHER RISK REVIEW.
See the Low Risk and Higher Risk Ethics Review Diagram [PDF 79.46KB] for an overview of the different review pathways.
NOTE: Exceptional Cases for Expedited Review: A.10: Risk Assessment, of the application form provides a section where you can make an exceptional case for your project to be considered through low-risk review, even if you have been unable to answer 'No' to all nine questions in SECTION A.
To help applicants plan their application, Word versions of the online ethical review application form are also available:
How do I apply for research ethics review? |
Full details about the online ethical review system, along with links to guidance and templates for supporting documents can be found in the section: How to apply for research ethics review.
APPEALS AGAINST DECISIONS OF A C-REC
The 5XÉçÇøÊÓƵ Research Governance Committee (URGC) has the responsibility to hear appeals against the ethical review decision of a C-REC in the event that all reasonable dialogue between the Committee and the researcher has failed to reach a suitable outcome. Please contact the Research Governance Officer for further information.
Appeals relating to the decisions of supervisors or School Research Ethics Officers (SREOs) should be dealt with in the relevant School of Study.
Research involving animals is reviewed by the Animal Welfare and Ethical Review Body (AWERB).
Research involving the NHS (patients, their tissure or data, staff or facilities) will require 5XÉçÇøÊÓƵ Sponsorship.
- Externally Funded Research Proposals
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In the case of externally funded research proposals, applications for ethical approval will normally be made once external funding has been approved, rather than at the point of application. However, as a matter of good practice, all bids for external funding should be subject to internal peer review prior to submission; this should include consideration of ethics.
- Social Care Research
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Ethical Review Guidelines for Social Care Research [PDF 92KB]
Social Care Research Flowchart [PDF 36KB]
- Research Ethics and Governance Standard Operating Procedures
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Standard Operating Procedures (SOPs) for the 5XÉçÇøÊÓƵ's Research Ethics Review Process
The SOPs for the 5XÉçÇøÊÓƵ's research ethics and research governance review process are set out in the Research Governance Standard Operating Procedures (last updated June 2017)