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Does your research require ethical approval?

To help determine whether your project requires formal ethical approval, please use the University’s Ethics Decision tool.

Important note: please use Firefox, Internet Explorer or Safari to access the tool, it is currently NOT working in Google Chrome.

If after using the tool you still have specific queries about your project, please contact your Ethics Signatory.

Please note, student projects refer to studies that are carried out as part of a University of Manchester degree programme (i.e. Undergraduate, Master’s, PhD, etc) and are supervised by a University of Manchester member of staff. Students are not permitted to seek ethical approval through the University of Manchester for research studies that are not a part of their coursework or programme requirements.

All studies must comply with the University of Manchester’s Research Governance policy and students must not conduct any unsupervised research.

Are you performing any of the following?

  • Evaluation (including course evaluation, service evaluation or teaching evaluation)
  • Market research

The University of Manchester does not normally require formal ethical review for these activities provided the following criteria are met:

  1. The data is completely anonymous with no personal information being collected (apart from their name, their publically available contact details and a record of consent)
  2. The data is not considered to be sensitive or confidential in nature
  3. The issues being researched are not likely to upset or disturb participants
  4. Vulnerable or dependant groups are not included
  5. There is no risk of possible disclosures or reporting obligations

Research Involving Interviews1 with Participants on Subjects Deemed to be within their Professional Competence

5. Items 1-5 above (note that item 1 can include an audio recorded conversation provided the transcript is fully anonymised and the recording then deleted)
6. The subject matter is limited to topics that are strictly within the professional competence of the participants

Audit of Data/Secondary data analysis

7. Items 1 and 2 above
8. You are able to provide explicit consent from the data controller to access the data
9. You are able to prove that the data will be used for a purpose which falls within the remit of the original consent provided by data subjects

IMPORTANT: Even if your study does not require formal ethical review, you must adhere to the following guidelines:

Ethical Review will be required in the following circumstances (unless classed as an exemption above)

  1. Research involving the collection or use of person-identifiable or special category data
  2. Research involving the collection or use of data which is classed as sensitive or confidential
  3. Research involving the use of audio/video recordings or photographs
  4. Research involving vulnerable groups, including children or adults with special needs
  5. Research involving the ingestion (by whatever means of delivery) of any substance by participants
  6. Research involving any invasive/semi-invasive procedure or the administration of drugs
  7. Research involving the physical testing of participants or the use of medical devices
  8. Research involving the use of psychological tests or interventions
  9. Research involving privileged access to clinical or personal records, or access to potential volunteers on the basis of their being or having been patients, or the invitation to volunteers to divulge facts about themselves which they would not wish the investigator to allow to become known to other persons
  10. Research involving any form of physical risk, distress, embarrassment, anxiety, stress, fatigue or inconvenience to the participant
  11. Research involving any form of adverse effect on the personal, social or economic well-being of the participant
  12. Research involving socially sensitive topics
  13. Research likely to uncover illegal or potentially harmful activities

Human Tissue Specific

The Policy on Compliance with the Human Tissue Act has recently been revised and updated. Please ensure you use the ethics decision tool to verify if your study requires UREC approval. If the tool indicates that ethical approval is required, Prop UREC should only be applied for where no donors will be recruited or new samples collected.

In all cases, it is a requirement that any researchers storing or using human tissue on UoM's premises register with the Research Governance, Ethics & Integrity Team. If you are storing tissue on the licensed premises of another organisation such as one of the Trust sites, please ensure you follow any local procedures to register your samples with the relevant DI. 

 

All of the above will require ethics approval from a Research Ethics Committee (UREC or NHS REC) but please note the list is not exhaustive.

In all cases of doubt, members of staff and students should contact their Ethics Signatory for additional guidance and support.

Additional resources available:

1: Please note that in this context the term 'interview' can also be replaced with the words 'focus group' or 'online questionnaire'.

Ethical Exemptions

Please note, if your study qualifies for an ethical exemption but you intend to publish the results of your research, you may still be asked for proof of ethical review from a journal or funder. Please ensure that you find out if this will be a requirement either by speaking with the journal/funder directly, seeking advice from your supervisor or asking colleagues who have previously published. If you are confident that this will be a requirement then please see below for additional advice.

We are able to offer formal letters of ethical exemption that can be submitted to journals or funders as proof of ethical consideration by this institution. If you would like to request a letter of ethical exemption for your research, please complete the below steps.

Please note, it may take up to 15 working days for letters to be generated so please ensure you submit your request in good time.

Please also note, letters CANNOT be granted retrospectively (once your research has started) so please ensure your submit your request before you begin recruitment or data collection.

Use the University’s Ethics Decision Tool in order to verify that your study qualifies for an exemption.

  1. Verify the outcome of the tool with your Ethics Signatory and in the case of student projects, also your supervisor.
  2. Send the following documents to research.ethics@manchester.ac.uk and be sure to include ‘Request for Letter of Ethical Exemption’ in the subject heading:
    • Screenshot of the outcome of the Ethics Decision Tool
    • Written confirmation from your Ethics Signatory that they agree with the outcome of the tool
    • Details of what confirmation you have received that this letter will be a requirement for publication
    • A copy of your data collection tools (i.e. interview topic guide, focus group schedule, questionnaire, etc)
    • A brief description of your proposed methodology including details of your participants and how they will be recruited
    • If using audio/video/photographs, please include details as to how these will be anonymised and what you plan to do with the recordings

For secondary data* studies only:

Use the University’s Ethics Decision Tool in order to verify that your study qualifies for an exemption.

  1. Verify the outcome of the tool with your Ethics Signatory and in the case of student projects, also your supervisor.
  2. Send the following documents to research.ethics@manchester.ac.uk and be sure to include ‘Request for Letter of Ethical Exemption’ in the subject heading:
    • Screenshot of the outcome of the Ethics Decision Tool
    • Written confirmation from your Ethics Signatory that they agree with the outcome of the tool
    • Details of what confirmation you have received that this letter will be a requirement for publication
    • Written confirmation from the data controller granting permission for you to use the data
    • Evidence that the proposed use of the data falls within the original consent of the data subjects (usually provided by the data controller)

*If you are conducting research on social media data please ensure you have read the Guidelines on the use of Social Media as well as using the ethics decision tool. 

For human tissue studies only:

Use the University’s Ethics Decision Tool (and HRA Decision Tool if appropriate) in order to verify that your study qualifies for an exemption.

  1. Verify the outcome of the tool with your Ethics Signatory and in the case of student projects, also your supervisor.
  2. Send the following documents to research.ethics@manchester.ac.uk and be sure to include ‘Request for Letter of Ethical Exemption’ in the subject heading:
    • Screenshot of the outcome of the Ethics Decision Tool(s)
    • Written confirmation from your Ethics Signatory that they agree with the outcome of the tool
    • Details of what confirmation you have received that this letter will be a requirement for publication, or is a requirement of the tissue provider
    • A brief description of your proposed methodology and confirmation that no new samples will be collected
    • Evidence that your proposed use falls within the remit of original consent, including where applicable that consent exists for genetic analysis
    • If using samples where you were involved in the original donor recruitment and collection please include confirmation that you are using the samples for the same purposes as specified in the original approved application  
    • Confirmation that any third party supplied tissues are fully anonymised to the research team

o    Written confirmation from the data controller granting permission for you to use the data

 

Research training/coursework

When determining whether your research requires formal research ethics approval, it's important to first distinguish whether you are conducting research training/coursework or research as part of your dissertation/thesis/staff project.

  • Research training is an activity usually conducted as part of coursework in a taught programme in which you collect and analyse a small amount of data in order to gain experience in research methodology, the synthesising of ideas and scholarly report writing.
  • Research is primary data collection or secondary data analysis intended to lead to the advancement of knowledge or understanding in a given subject area. This type of activity in a taught programme is usually reserved for the final dissertation.

When using the University's Ethics Decision Tool, please keep in mind which of these categories your project falls into as it will help you to navigate through the tool successfully.

Please also note, if conducting research training as part of your coursework there are a number of requirements and expectations in relation to how you design your work. In addition to these, your Course Director, Programme Director or Unit Lead may have additional requirements so please ensure you speak with them directly if you have any queries.

In general, activities to be conducted as part of research training must be low risk and adhere to the following criteria:

Participant groups must be limited to one or more of the following

  • Adults who are able to give informed consent in a way that accords with accepted practice
  • Participants in professional roles who will be interviewed about their professional practice. Interviews will be conducted in their work setting.
  • Participant groups limited to peers, colleagues and family members

And all of the following additional criteria must be met

  • The research will not involve vulnerable or dependent groups.
  • The research will take place in public or private locations where the safety of the student can be protected and the privacy of participants can be guaranteed.
  • The research will be conducted with participants inside the EU or an international setting that is not on the list of countries/regions that the Foreign and Commonwealth Office advises against 'all but essential' travel to.
  • The research will not involve the collection of video/photographs of research participants.
  • The research will not require research participants to provide information likely to cause them significant levels of distress.