Decision Tool

Do I need ethical approval from a REC?

Does the following apply to your study?

Study involving humans as participants and/or their data/tissue?

Yes
If none of the above apply, please select no
No
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Do any of the following apply to your study?
Are you performing a service/practice evaluation?

For help understanding what UREC would consider to be a service/practice evaluation, please click here.

Yes
Are you performing an audit of a service/practice?

For help understanding what UREC would consider to be an audit of a service/practice, please click here.

Yes
Are you performing module/programme evaluation?

This is a normal part of academic activity and should be authorised by appropriate School/faculty authorities.

Yes
Are you performing market research or research into public opinion?

The activity of collecting and studying information about what people want, need and buy or people’s views, attitudes and beliefs about a particular topic. 

Yes
If none of the above apply, please select no
No
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Does the following apply to your study?
Are you auditing data/performing secondary data analysis?

Data audit is the processing of data which has previous been collected. A data audit refers to the auditing of data to assess its quality or utility for a specific purpose. Auditing data involves looking at key metrics, other than quantity, to create conclusions about the properties of a data set.

Secondary data analysis is the use of data collected for some other purpose. The data would have been collected for research purposes if new knowledge can be derived (e.g. from testing a hypothesis or identifying/exploring themes following established methodology). If collected for research purposes, if applicable, the research must have been ethically approved.

Yes
If none of the above apply, please select no
No
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Can you confirm that all of the following criteria are met?

  • The data is completely anonymous (can include an audio recorded conversation provided the recording device is appropriately secured and the transcript is fully anonymised) with no personal information being collected (apart from their name, their publically available contact details and a record of consent). For help understanding what LJMU would consider to be anonymous data please click here
  • It will not be possible to directly or indirectly identify participants in any resulting report
  • The study will not cause damage and distress. For help understanding what LJMU would consider to be damaging and distressful please click here.
  • Study data/information will not be collected from vulnerable or dependent groups.

If all of the above apply, please select yes
Yes
If none of the above apply, please select no
No
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Can you confirm that all of the following criteria are met?

  • The data is completely anonymous (can include an audio recorded conversation provided the recording device is appropriately secured and the transcript is fully anonymised) with no personal information being collected (apart from their name, their publically available contact details and a record of consent). For help understanding what LJMU would consider to be anonymous data please click here
  • It will not be possible to directly or indirectly identify participants in any resulting report
  • You will obtain explicit consent from the data controller to access the data/information.

If all of the above apply, please select yes
Yes
If none of the above apply, please select yes
No
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YOUR ANSWERS INDICATE THAT YOU NEED REC APPROVAL.

To apply for ethical approval please visit the LJMU Research Ethics and Governance webpages

Please note

  • Service evaluations and clinical audits conducted in the NHS require approval from the lead NHS trust.
  • Research undertaken in the NHS may require HRA approval as well as UREC or school/faculty REC approval. For more information click here
  • Research undertaken in the NHS or involving certain methods may require NHS REC approval instead of UREC or school/faculty REC approval. For more information click here


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YOUR ANSWERS INDICATE THAT YOU DO NOT NEED UREC APPROVAL.


YOUR ANSWERS INDICATE THAT YOU MAY NOT NEED SCHOOL/FACULTY REC APPROVAL – this depends on the REC. For more information please visit the Research Ethics & Governance webpages.  For further advice, please email UREC on researchethics@ljmu.ac.uk or the school/faculty REC

Whether ethical approval is required or not, studies that involve humans and/or their data must be conducted according to the principles of research ethics. Key principles:

  1. Consideration of the dignity, rights, safety and wellbeing of participants. All participants must be informed in advance about potential risks or harm. Harm must be minimised and the anticipated benefits must justify the risks incurred by participants.
  2. Process of informed and valid consent. This process normally requires participants to be provided with information on the purpose of research, potential risks, data collection, security of data, use of data, the right to withdraw and contact information. Please visit the LJMU Research Ethics & Governance webpages for the LJMU Participant Information Sheet template.
  3. A formal consent process, or adequate efforts to inform participants appropriate to the needs and context of the study.
  4. Anonymity: Participants should be informed if the data that you collect from them will be identifiable or fully/partially anonymous and participants should be provided with assurance as to how anonymity will be protected where appropriate.
  5. Data protection: You must ensure that data is appropriately handled and securely stored in accordance with the Data Protection Act (2018) and the General Data Protection Regulation (GDPR).
    • GDPR compliant participant information sheets and consent forms
    • LJMU data protection guidelines
    • Study advertisements, introductory letters/emails or other forms of recruitment
    • If applicable, provide gatekeeper information sheets and obtain written/recorded verbal consent or letters of permission from organisations or gatekeepers.
    • A signed and completed risk assessment may be needed

The key principles of research ethics are addressed in detail in the LJMU Research Ethics Training

Please note

  • Service evaluations and clinical audits conducted in the NHS require approval from the lead NHS trust.
  • Publishers should accept that activities that do not require ethical approval are exempt from ethical approval. If there is an intention to publish, investigators are advised to check with the publisher and submit an application for ethical approval if required. Ethical approval cannot be obtained once a study has started.

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Do I need formal ethical approval from a Research Ethics Committee (REC)?

Your answers indicate that you need REC approval.

Before you apply for ethical approval please complete the LJMU Research Ethics Training (which is mandatory for students)

To apply for ethical approval please visit the LJMU Research Ethics and Governance webpages

Please note

  • Service evaluations and clinical audits conducted in the NHS require approval from the lead NHS trust. 
  • Research undertaken in the NHS may require HRA approval as well as UREC or school/faculty REC approval. For more information click here 
  • Research undertaken in the NHS or involving certain methods may require NHS REC approval instead of UREC or school/faculty REC approval. For more information click here

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