All dissertations have ethical considerations and should follow best practice guidelines (such as using GDPR compliant participant information sheets, taking informed consent and following University of Manchester data protection guidelines).
As described in the Dissertation Guide, before starting recruitment or data collection for your research, you must first use the ethics decision tool to help you and your supervisor determine whether formal ethical approval of your research is required. Guidance on using the tool is included in the dissertation guide and below. Please ensure you have completed this step before beginning any further ethical approval process. The Faculty of Biology, Medicine and Health have a helpful guide on Research Ethics and it is recommended that you read this before attending any dissertation workshops so you can raise any queries.
The ethics decision tool is designed to help you and your dissertation supervisor determine whether your dissertation requires ethical review and if so, by which ethics review body: UREC or HRA (NHS REC). The ethics decision tool can be found here.
You are required to complete the online tool. This presents you with an initial outcome based upon the information you gave to the decision tool, which must be reviewed and verified by your supervisor. A copy of your outcome slide (screenshot) should be included in your dissertation proposal form and submitted to the Blackboard Dissertation Unit, as well as keeping a copy of the outcome slide for your own reference, by clicking the ‘Print’ button located on the final decision page, and use the option to save as a PDF.
Once your final outcome slide has been submitted and approved, if the outcome ethics tool identifies that you do not need ethical approval for your dissertation then no further action requiring ethics is needed. However, though you may not need ethical approval you still must adhere to all ethics best practice which is listed here.
Should you wish to publish your study in a peer-reviewed journal then you need to send the following items to email@example.com:
- An overview of the project including what data you are collecting from whom, in what format and where
- Screenshot of the outcome of the ethics decision tool
- Confirmation from the supervisor that the outcome of the tool is correct
- Confirmation from the Ethics Signatory that the outcome of the tool is correct
- The title of the project and the full name/title of the Principal Investigator (PI)
They would then be able to offer you a letter of ethical exemption. This letter may be required by a journal before they will publish. It is important that you do this at the start of your study. You cannot apply for this letter retrospectively.
If the ethics decision tool identifies that you need ethical approval then please refer to the guidance in the next section of this guide which fully describes how you, supported by your supervisor, will go about this process.
Important: If your study does need ethical approval you must not begin recruitment or data collection for your dissertation until you have received formal email confirmation (including a PDF letter) of a favourable ethical opinion.
Ethical approval cannot be given retrospectively and commencing work on a dissertation without confirmation of ethical approval is classed as an ethics breach and will be reported as such to the Head of Research Governance, Ethics and Integrity.
If applying for Proportionate UREC approval, your application can take up to eight weeks to receive formal ethical approval and if applying for full UREC approval, it can take up to twelve weeks. Therefore, students are advised to complete this element of their dissertation as soon as possible.
If ethical approval is required, you will have to determine whether you need NHS ethics committee review (NHS REC). For ethical approval in the NHS there is NHS REC for research or UREC for University research. It is possible that your study may also require Health Research Authority (HRA) assessment if you are planning to access Trust premises, equipment or staff. Therefore you may need NHS REC, UREC, HRA or a combination of these approvals. To check, first use the University’s Ethics Decision Tool, which will ask you if you are planning to undertake research involving the NHS. If you’re unsure, you can check this by using the HRA decision tool.
Important: If the outcome of the HRA decision tool is that approval by the NHS REC and/or HRA is not needed, you still must go back to the University’s Ethics Decision Tool to check if UREC approval will be required.
The ethics decision tool will ask you if you are doing work in the NHS. If you don’t know, it will tell you to use the HRA decision tool and if the answer is ‘no’ to that tool, to come back and check if UREC is needed.
If you believe that your research falls into this category you should seek further advice and discussion from the Faculty’s Research Governance team: FBMHethics@manchester.ac.uk.
Supported by your dissertation supervisor and any other relevant academics, you will be required to make the decision as to whether your research requires a full committee review or whether it would meet the criteria for a proportionate review. The most common criteria that is misread refers to studies being conducted outside of the European Economic Area (EEA). Therefore, it is imperative that you read the criteria carefully, refer to the university guidance and discuss with your supervisor.
Full details and guidance relating to University policy and on applying for ethical review can be found here.
If the HRA decision tool tells you that your research requires NHS REC review, you and your supervisor will need to complete an IRAS application which can be accessed here.
If the HRA decision tool tells you that NHS REC is not needed, you must still use the University’s Ethics Decision tool to see if UREC is needed. There are some cases where NHS REC is not needed but R&D permission is needed (e.g. to step foot on NHS premises). If R&D is needed, you must also check if UREC is needed.
If you obtain NHS REC then you do not need to obtain UREC approval (you can only get your ethics from one place, NHS REC or UREC but not both).
Prior to commencing this process you should visit the University’s ethical guidance at https://www.staffnet.manchester.ac.uk/rbe/ethics-integrity/ethics/. You should also contact the Faculty Research Governance Office (FBMHethics@manchester.ac.uk ) who can provide assistance with your IRAS application.
If approval from UREC is required, there are two different routes currently available: Proportionate UREC (for low risk projects) and full UREC (for high-risk projects).
Proportionate UREC review is available for low risk projects. Low risk projects are defined by the Proportionate UREC criteria, which can be found at: https://www.staffnet.manchester.ac.uk/rbe/ethics-integrity/ethics/
If the study doesn’t meet all of the mandatory criteria for the proportionate review, then the study must go through full UREC review. If you have any questions then you can contact the Ethics Signatories for the Division of Population Health, Health Services Research and Primary Care (Kelly Howells, or Christine Robinson) for further advice.
It is imperative that both you and your supervisor read the information available on the Research Ethics web pages before deciding on which avenue of approval from UREC is needed, as ultimately, it is your responsibility to ensure that the correct ethical approval is sought and confirmation received.
Your supervisor is co-responsible for your dissertation and must be listed as the data custodian on your ethics application and, if applicable, data management plan.
For both routes of UREC approval, you and your supervisor will need to create and submit an application using the University Ethical Review Manager (ERM) system via the following link: https://submission-ethicalreview.manchester.ac.uk.
To login to the ERM system you will need your standard university username and password.
Guidance on using the ERM system is available here: https://www.staffnet.manchester.ac.uk/rbe/ethics-integrity/ethics/erm/
Please note that the UREC does not read protocols and nor should they be attached with the submission.
In the ERM system, the forms should be completed by you the student with guidance and input from your supervisor where required. To share the forms with your supervisor:
- Ensure that your supervisor’s details are listed in Section B of the form using the Search feature. If the supervisor is not listed in the drop down menu they have not activated their ERM account yet. They should to log into the ERM system and then log out again. The system will retain a copy of their details for future use and they will now appear in the Search feature
- You should then ‘share’ the application with your supervisor so they can review the content as appropriate
- When using the Share function you should ensure you tick all permissions in the pop up window
- Once the final version is ready, you should use the ‘request signature’ button to request the signature of your supervisor
- Supervisors should follow the specific instructions provided via email for signing the form in the ERM system which includes opening the application in the ERM system and looking on the left hand side of the screen for the Sign button with an icon of a pencil on it
- Once signed by both parties you will receive a green confirmation message at the top of the screen. Once this happens you need to remain in the system until the form automatically submits (usually an additional 10-15 seconds). If you don’t do this, the form won’t submit
- Once submitted a confirmation email will be sent to both yourself and your supervisor
- If you do not receive this email, you must liaise with your supervisor to ensure the form has been completed correctly
Once the form has been submitted:
- It will be sent to a designated ethics signatory within the Division of Population Health, Health Services Research & Primary Care for a pre-screen check. The designated ethics signatory may request changes to the application before forwarding to UREC for consideration (in which case the student and supervisor will be notified via email of the required changes)
- It can only be changed once the designated ethics signatory has returned it to the student/supervisor in the ERM system
- Once any changes have been made the form must be re-signed and submitted back to the ethics signatory for a final check
Once the designated ethics signatory has pre-screened the application and forwarded it for UREC review, you and your supervisor will be notified via email.
If applying for Proportionate UREC, the review process will take 10 working days in the first instance and will be performed by a digital committee. Any required changes will be communicated via email with the application being returned to you/your supervisor in the ERM system. Once any required changes have been made and the form has been re-signed and resubmitted, the revised documentation will be reviewed by the Chair and the final decision will be communicated via email with a copy of the formal letter of ethical approval (in PDF format) attached.
If applying for full UREC review, you/your supervisor will receive a formal invitation to attend a UREC committee meeting and should respond to this invitation by following the instructions as outlined in the email. The panel meetings will be exclusively online for the 22/23 academic year.
Attendance at the meeting is mandatory and therefore you and your supervisor should liaise with the Research Ethics team to ensure that the meeting time and date are suitable for your schedules. Your supervisor must also attend the UREC meeting (or send a suitably qualified member of staff in their absence). The UREC will not permit you to attend the meetings alone.
After attending the UREC meeting you/your supervisor will be informed of the outcome within 7 working days. The possible outcomes are as follows:
- provisional favourable subject to required revisions
In the case of a provisional favourable outcome, you/your supervisor will be provided with comments from the UREC and be required to make specific changes to the proposal, which will then be resubmitted for further consideration. In this case you/your supervisor should amend a copy of the feedback letter to include your responses to the points raised by the Committee and attach this to your revised application in the ERM system. The Committee is unable to accept revised applications unless this is attached.
In the case of an unfavourable outcome, essentially you have to return to the drawing board and start from scratch, preparing a new application that goes through the Ethics Signatory and is allocated to another UREC meeting.
For Prop (proportionate) UREC, unfavourable opinions usually mean the study has to go to full UREC review.
It is expected that your supervisor will fully engage with you during the ethics review process to assess which form of documentation is required and ensuring that disciplinary norms are adhered to in all instances. Your supervisor is responsible for assessing the level of ethical risk with you, reviewing all ethics documentation prior to submission (and offering suggested improvements if necessary) and signing off on the final application. Your supervisor is also required by the University to be the data custodian for the project and should be listed as such on the ethics documentation.
If applying for UREC ethical approval, the ERM system allows both you and your supervisor to add comments to the application using the speech bubbles located to the right hand side of the questions in the form. These comments are confidential between you and your supervisor and allow for an ongoing discussion regarding the content of the form.
All research studies seeking approval from a Division/School based Committee or UREC after the 25th of May 2018 must use the new GDPR compliant templates for participant information sheets and consent forms. You can find these here.
A number of templates are available which provide general guidance to most types of research studies as well as tailored guidance for studies using special category data and those which are medically focused. The required information in relation to GDPR can be found in all templates but is worded differently depending on the nature of the study. Therefore you should select the template which is best suited to the type of research you will be conducting.