Here at the University of Manchester there are 5 possible routes of ethical review and approval:

1. Division/School Review: Low risk student projects only

2. Proportionate University Research Ethics Committee (UREC) Review: Low risk staff or student projects

3. Full University Research Ethics Committee (UREC) Review: High risk staff or student projects

4. Health Research Authority (HRA) Approval (including NHS REC)

5. Both HRA and UREC approval

Please click on the submenus below for additional information on each of these routes of ethical review and approval:

A limited number of Divisions/Schools/Departmemts across the University have the ability to provide ethical review of low/medium risk projects at Division/School/Department level, providing they adhere to a specified set of criteria. As this criteria varies between Divisions/Schools/Departments it is imperative that you take the time to read the guidance notes below if you wish to apply for ethical review at Division/School level. Please also ensure you discuss this with your supervisor as mistakes can result in substantial delays to the ethical review process. If you do not see your Division/School listed below then it does not currently have this avenue available and you will need to apply for ethical review via UREC. 

Please note this route of ethical approval is ONLY available to students. All UoM staff members must apply for either Proportionate or full UREC for their own projects.

Guidance Notes for Divisional/School Review

• Alliance Manchester Business School
  
• Arts, Languages and Cultures
• Computer Science
• Civil Engineering & Management 
• Environment, Education and Development
• Pharmacy
• Psychology Research (i.e. Division of Psychology, Communication and Human Neuroscience and Division of Psychology & Mental Health)
• Social Sciences

If you have any queries as to whether the specifics of your project meet the criteria listed in the guidance notes above, please first discuss these with your supervisor. If after doing this you still require additional assistance, please see table below for a list of useful contacts:

To see a flowchart of the steps for applying for Division/School review, please click here.

Proportionate University Research Ethics Committee (UREC) Review

Proportionate UREC review is available to those researchers (staff and students) conducting low risk projects which are defined as adhering to the Proportionate UREC criteria outlined below.

**Denotes mandatory criteria that must be met in order to qualify for Proportionate UREC review. If your study does not meet these mandatory criteria you will need to apply for full UREC review, where appropriate.

If your research involves an activity falling within one of the conditional criteria beginning with “If” then it must meet the requirements of that criterion or criteria to be considered for Proportionate UREC Review.

Participants and Consent

• **Involves only participants who are non-vulnerable adults able to give informed consent or, if children/ young people are involved, they must be in an educational setting/accredited organisation and have the opportunity to assent with parental/guardian opt-in consent also provided.

Data Collection and Experimental Procedures

• **Data collection does NOT involve a significantly coercive recruitment strategy, or a recruitment strategy that is likely to be experienced as coercive by participants, including where a power dynamic between the researcher/participants or the gatekeeper/participants would be present
• **Data collection does NOT involve activities that could be interpreted as or lead to the potential exploitation of participants
• **Does not involve physically invasive procedures (please note physically invasive refers to any test in which the skin of the participant is broken, or an implement is inserted into any opening of the human body, or involves the taking of body samples such as saliva, hair, urine, faeces, sputum, blood, skin, nails, or taking biopsies of any form for any purpose, or any form of scanning such as ultrasound scans or fMRI).
• **Does not involve activities that pose a significant risk of causing physical harm or more than mild discomfort.
• **Does not involve activities that pose a significant risk of causing psychological stress or anxiety.
• **Does not involve asking participants to take part in activities that pose a significant risk of having an adverse effect on their personal well-being (e.g. physical and psychological health), social well-being (e.g. social standing, social connectedness) or economic well-being (e.g. employment, employability, professional standing).

Important notes:

• Studies involving EEGs may be submitted for Proportionate UREC review as they are NOT classed as physically invasive. 
• The following standard audiology techniques are NOT classed as physically invasive however in order to qualify for Proportionate UREC review they must be performed only on healthy adult volunteers with the capacity to consent. If performed with other groups, e.g. children, full URECreview is required:
  • Collecting otoacoustic emissions (transient, distortion product and spontaneous). 
  • Measuring Acoustic reflex thresholds
  • Performing Otoscopy (looking in the ear to see if it is clear/occluded)
  • Tympanometry (checking the pressure of the outer ear)
  • Standard hearing tests
• Please note that studies involving medicines, drugs, placebos or foodstuffs containing common allergens (e.g. nuts) will require full UREC review.
• If your study involves confectionery or foodstuffs that are unlikely/unexpected to cause allergic reactions in participants then it may qualify for Proportionate UREC review. Similarly, studies involving the use of common substances purely to invoke a particular sensation of smell may qualify for Proportionate UREC review.

Sensitivity of Topic or Data

• **Does not involve collecting or revealing data that enables individuals, groups or organisations to be identified in such a way that they could experience negative effects on their personal, social or economic well-being.
• **Does not involve asking research participants to provide personal and sensitive information likely to lead to significant levels of distress (ie research must only involve topics that are either not contentious or sensitive at all, or where a reasonable person would agree the topic is of legitimate interest and may result in distress only in rare instances).
• If topics being researched are of a sensitive nature, they are not personal to the participants.
• If using video recording or other images captured by the researcher and/or research study participants, the researcher is able to guarantee controlled access to authorised viewing.
• If researching professional practice, participants are in professional roles and the research is conducted in their work setting. It would also be acceptable to conduct these interviews via telephone or Zoom/Teams as long as the content of the interviews is focused on professional practice and non-sensitive topics. Please note that in this instance, participants will be responsible for ensuring appropriate privacy arrangements.
• If conducting observations, they will be on ordinary, non-sensitive behaviours.

Location of Data Collection

• **Data collection does NOT involve travel to or travel within an international setting that is on the list of countries/regions that the Foreign and Commonwealth Office advises against 'all but essential' travel to.
  • Please note: it is the responsibility of the researcher to contact the Information Governance Office (information.governance@manchester.ac.uk) with any queries or concerns regarding the import or export of data from outside the UK.
• **Will be carried out within normal working hours or at a time convenient to participants.
• If research will involve going into the homes of participants, you must confirm one of the following¹:
  • Student projects: participants will be limited to family and friends.
  • Staff projects: participants may include members of the general public providing a completed and signed risk assessment has been attached in support of this application.

• If conducting observations they will be located in a public space or the clearly public areas of a building (e.g. the high street, the University campus, the entrance hall of a town hall).
• If research is limited to the secondary use of previously collected, identifiable data from outside of the EEA:
  • A material transfer agreement is in place between the data controller and the University of Manchester. A copy must be appended to the application or confirmation in writing that this is currently being drafted.
  • The researcher is able to attach proof that the analysis which will be performed falls within the consent of the data subjects (e.g. that the data can be used for future research).

Social Media Studies

• Please review the social media guidance to see if your study can be submitted for Prop UREC review or if it will require full UREC.

Human Tissue Specific Criteria (if applicable)

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.

1: Important note: performing research in the homes of participants raises specific ethical issues in terms of the privacy of participants as well as increased risks to the researcher. Therefore, the Proportionate UREC reserves the right to escalate any applications to the full UREC if it is felt that these pose too great a risk to the participants or researcher for the specific study submitted for review.

All applications to the Proportionate UREC Committee will still require a pre-screen check from a designated Ethics Signatory, a process which may take up to 10 working days. To apply for UREC Proportionate Review, researchers will need to create an application in the ERM online system and select the appropriate option in Section A. 

Studies submitted to the Prop UREC must be low risk with clearly described elements and meet all the required criteria for Prop UREC.  If your study involves multiple work packages, complex data collection techniques and or non-standard consenting procedures, please note that additional time may be required to complete the review process and additional UREC colleagues may be asked to contribute to the review of the project to ensure all ethical considerations have been appropriately mitigated. As with any study submitted to the Prop UREC, the Chair also reserves the right to require that the application is submitted to the full UREC if they feel that any of the criteria are not adequately met or that the study requires the consideration of the full panel as opposed to selected members.

If your application proceeds to Proportionate UREC Review you will not be required to attend a Committee meeting as all reviews are conducted electronically via the ERM system. After your Ethics Signatory has approved your application it will be sent out for review by the Proportionate Committee who will then communicate their decision to you within 16 working days. If revisions are required to your application or supporting documentation, these must be made within 5 working days of receiving them and resubmitted to the Committee for final approval.

If you have any queries regarding this process please contact your designated Ethics Signatory.

To see a flowchart of the steps in applying for Prop UREC review, please click here

Guidance on Applying for Full University Research Ethics Committee (UREC) Review

Who should apply?

You will need to apply for full UREC review if:

• You are a student and your project DOES NOT meet the criteria for Division/School review (if this route is available to you) or Proportionate UREC review
• You are a member of staff and your project DOES NOT meet the criteria for Proportionate UREC review

      This may be due to the fact that your research involves:

• Vulnerable or dependant groups
• Invasive procedures
• Psychological tests for clinical purposes
• Activities which pose a significant risk of having an adverse effect on the personal, social or economic well-being of participants
• Topics which may cause a significant level of embarrassment, distress, anxiety or fatigue
• Topics which are socially or personally sensitive
• Topics which are likely to uncover illegal or potentially harmful activities
• Data collection involves travel to or travel within an international setting that is on the list of countries/regions that the Foreign and Commonwealth Office advises against 'all but essential' travel to.

Please note that the above list is not exhaustive and there may be other reasons why your research must be submitted for full UREC review. If you have any additional queries on the specifics of your project please contact your Ethics Signatory for advice.

To see a flowchart of the steps for applying for full UREC review please click here.

If you have not attended a University Research Ethics Committee before, or it is some time since your last application, we recommend reading our guidance on attending UREC meetings.

The Ethics Signatory is responsible for screening all applications for UREC review and can provide advice to staff and supervisors with research ethics queries, including guidance on the outcome of the ethics decision tool, that cannot be answered by the guidance found on the website, or by the local Ethics Chair (Humanities, MACE, Computer Science, Pharmacy, Psychology & Human Neuroscience Divisions only).

Please note that students should contact their supervisor in the first instance with any queries.

The Ethics Signatory can be contacted via research.ethics@manchester.ac.uk

If your query relates to data protection, data management, contractual or data sharing agreements, HRA/NHS REC, insurance, health & safety or safeguarding please see the Contacts section below. 

The Health Research Authority (HRA) has issued updated guidance (Sept 2021) on student project eligibility criteria. Please see https://www.hra.nhs.uk/planning-and-improving-research/research-planning/student-research/ for full details, including suggested alternatives to conducting research requiring ethics review. 

All information for studies that require NHS ethical approval or HRA Assessment (formally NHS R&D) can be found in the Faculty Research Governance Pack. Please ensure that you download the pack each time you begin a new study to ensure you are reviewing the most up to date information.

For all queries related to these types of studies please email FBMHethics@manchester.ac.uk

All information for studies that require NHS ethical approval or HRA Assessment (formally NHS R&D) can be found in the Faculty Research Governance Pack. Please ensure that you download the pack each time you begin a new study to ensure you are reviewing the most up to date information.

For all queries related to these types of studies please email FBMHethics@manchester.ac.uk

For studies requiring UREC Review* and HRA approval (HRA study wide assessment only or R&D approval outside of England) please complete the following steps: 

1.    Complete the UREC application form* (either Proportionate or full UREC) which will be submitted to your Ethics Signatory for a pre-screen check. Once checked it will be forwarded for allocation at the next available UREC* Committee meeting (or sent out to the digital Proportionate UREC Committee). 

2.    If required, please ensure you amend your application and supporting documentation in accordance with the feedback provided by the Committee and re-submit for final approval.

3.    Once you receive your UREC* approval letter you will need to generate an HRA application using IRAS. The Faculty Research Governance Pack contains relevant guidance and standard answers for the IRAS form and can be downloaded from: www.staffnet.manchester.ac.uk/bmh/research/ethics-and-regulatory-support/

4.    Use 9b Study Document Checklist_UREC_HRA from the pack and forward the checklist along with the supporting documents listed, and a pdf copy of the IRAS application form, to your University Sponsor representative who will aim to review your documentation within one working week. Please note that the following documents from the pack will be able to assist you in completion and should be used: 2. IRAS standard answers & Guidance, 3. UK local Information Pack, 4. Organisational Information Document guidance, 21. Quant-Qual Studies Helpsheet (if applicable to your study).

5.    Your sponsor representative will liaise with you directly regarding any clarifications to your documentation and will also generate your letters of insurance and indemnity. If required, please ensure you amend your IRAS form and supporting documentation in accordance with the feedback provided by the University Sponsor representative.

6.    Once the application is finalised, you will receive sponsor confirmation that the application is ready to be authorised and submitted to the HRA. Follow the instructions in IRAS to upload your study documents to the IRAS checklist and request electronic authorisations. Once all authorisations are in place, follow the instructions under the e-submission tab to book in and submit your application online.

7.    Once submitted to the HRA, your application will be reviewed by an HRA assessor. You may receive questions or requests for further information from the assessor. Most questions can be answered by the research team but, contact your sponsor representative if you need help.

8.   You will be notified by the HRA when you can start sending documentation to the sites as part of the site set-up process; this may be before you get the final outcome. Follow the guidance in the ‘Site specific information’ section of the IRAS help module to determine what should be included and how to send the information to the sites.

9.   When the final HRA approval is issued for your study, you should send a copy to the sponsor representative (if not copied to the HRA email). You must also submit a formal amendment in the ERM system to your approved UREC application. In this amendment request please attach a copy of the HRA approval as well as copies of any supporting documents that have been updated since UREC* approval was obtained. 

10. Once the amendment has been approved by the UREC*, forward a copy of the confirmation email to your University Sponsor representative who will then provide the sponsor green light (SGL) for your study. When the SGL is issued, you will be able to start the study at sites that have confirmed capacity and capability (C&C)/ approved your study.

For more information about the HRA Approvals Process, see the Faculty Research Governance website.

*Please note, if you are a student from a Department/Division/School with a low-risk approval route, you may also seek approval through that route for your study if it meets all of the required criteria. Department/Division/School approval is granted on delegated authority on behalf of UREC and therefore can be submitted to the HRA in order to obtain the required approvals.

For Human Tissue Studies

You will be required to store and use the samples under the University of Manchester's HTA License for Research as well as seek appropriate UREC approval. Please see our HTA Guidance for more information.

If you are planning an international collaborative project with multiple sites and at least one of those sites proposes to recruit NHS patients, you may require approval from both the NHS REC as well as UREC. NHS REC approval will be required for any study that involves NHS patients or their data and more details about these requirements can be found here.

Important notes:

•  You should include details of all sites (both UK and abroad) in your application to the NHS REC. The NHS REC will review an application that includes international sites but, the review is undertaken in the context of the UK’s legal and policy framework, it does not consider any issues that may be specific to conducting or managing the research outside of the UK. Where a study includes participants at other sites that are outside of the UK, UREC approval will also be required.

•  For your application to UREC, you should mention that the study includes at least one site in the UK which involves NHS patients and the details of that specific site as well as any associated data collection measures will be reviewed by the NHS REC. You should then ensure the details of your application focus primarily on the sites external to the UK that do not involve NHS patients and all associated data collection methods. Although the UREC will not comment or review the content associated with NHS patients, it is helpful to the Committee to understand the full scope of the study and any additional approvals that will be sought.

Researchers will need to check if the international sites require that local ethical approval is obtained and if so, whether this should be obtained before or after submitting to the NHS REC/UREC. Researchers may also need to work with other University teams to make sure there are appropriate arrangements in place for the study being conducted outside of the UK. For example, the Contracts Team to ensure that there are appropriate agreements in place with international sites/ collaborators; the Information Governance Office if data will processed outside the UK or shared between the UK and international sites; the Insurance Office if there are questions about the insurance/indemnity arrangements etc.

In order to assist researchers with navigating the NHS REC/ UREC approval process for such studies, please see below for specific advice regarding the steps that should be taken:

1. Check with the sites regarding the need for local approvals and if these are required, whether these should be sought now or after UK approvals are obtained
2. Generate an IRAS application using the Integrated Research Application System (IRAS): https://www.myresearchproject.org.uk/. The Faculty Research Governance Pack contains relevant guidance on how to set up your project and can be downloaded from: www.staffnet.manchester.ac.uk/bmh/research/ethics-and-regulatory-support/.
3. Complete the Study Document Checklist NHS REC_HRA document from the pack and send via email to your University Sponsor representative, along with all the supporting documents (including your protocol and draft IRAS form). Your University Sponsor representative will aim to review your documentation within 15 working days. Please note that the following documents from the pack will be able to assist you to complete the application and should be used, where applicable to the study: IRAS standard answers & Guidance, UK local Information Pack, Organisational Information Document guidance, Quant-Qual Studies Helpsheet, Data Helpsheet and Tissue Helpsheet.
4. Your sponsor representative will liaise with you directly regarding any clarifications to your documentation and will also generate your letters of insurance and sponsorship. If required, please ensure you amend your IRAS form and supporting documentation in accordance with the feedback provided by the University Sponsor representative.
5. Once the application is finalised, you will receive sponsor confirmation that the application is ready to be authorised and submitted to the HRA. Follow the instructions in IRAS to upload your study documents to the IRAS checklist and request electronic authorisations. Once all authorisations are in place, follow the instructions under the e-submission tab to book in and submit your application online.
6. Once submitted to the HRA, your application will be reviewed by the NHS REC and/or HRA assessor. You may receive questions or requests for further information from the REC/assessor. Most questions can be answered by the research team but, contact your sponsor representative if you need help.
7. You will be notified by the HRA when you can start sending documentation to the sites as part of the site set-up process; this may be before you get the final outcome. Follow the guidance in the ‘Site specific information’ section of the IRAS help module to determine what should be included and how to send the information to the sites.
8. When the final HRA approval is issued for your study, you should send a copy to the sponsor representative (if not copied to the HRA email).
9. Once you receive HRA approval, complete the Prop UREC application form, selecting the below options for the fast track route, which will be submitted to your Ethics Signatory for a pre-screen check. Once checked it will be forwarded to the digital Proportionate UREC Committee for light touch approval. 
   • Staff: in C1 select Patients both in the UK as well as internationally and requires approval by both the NHS REC as well as the UREC 
   • Students from an area with a local route of ethics review: in C2 select No, in C3 select Patients both in the UK as well as internationally and requires approval by both the NHS REC as well as the UREC 
   • Students from all other areas: in C3 select Patients both in the UK as well as internationally and requires approval by both the NHS REC as well as the UREC 
10. If required, please ensure you amend your application and supporting documentation in accordance with the feedback provided by the Committee and re-submit for final approval.
11. Once you receive UREC approval, forward a copy of the approval email to your University Sponsor representative who will then provide the sponsor green light (SGL) for your study. When the SGL is issued, you will be able to start the study at sites that have confirmed capacity and capability (C&C)/ approved your study.
12. For more information about the HRA Approvals Process, see the Faculty Research Governance website.

It’s important to note that additional routes of ethical review exist outside the University if the project is involving the NHS, Chester Zoo, prisoners, young offenders or military data.  If a project will require approval from one of these or other external organisations not listed here, researchers should contact their Ethics Signatory for additional advice and support.

MODREC

If your research will involve Ministry of Defence personnel or data or is funded/sponsored by the MOD you should first verify if ethical approval from the MOD’s Ethics Committee (MODREC) will be required. More information is available here: https://www.gov.uk/government/groups/ministry-of-defence-research-ethics-committees 

Please note if the study is sponsored by UoM a copy of the sponsors checklist and full application should be submitted to research.ethics@manchester.ac.uk once you have obtained Scientific Assessment Committee (SAC) approval. The sponsor checklist cannot be signed off by the PI. You should allow 10 working days for this to be completed.

UoM will accept MODREC approval in lieu of its own so no separate UREC approval is required, however a copy of the final approved application form, supporting documents and letter of approval should be submitted to research.ethics@manchester.ac.uk once obtained.

Chester Zoo

If the project is working in collaboration with Chester Zoo, UoM has a collaborative agreement in place for specific types of projects that allow ethical review to take place at either the University or at the Chester Zoo Ethics Committee.

HMPPS

If the project is planning on working with staff and/or offenders in prison establishments, the National Probation Service or within HMPPS Headquarters it will require dual approvals from HMPPS as well as UoM ethical approval. Approval from UoM should be obtained first before an application to HMPPS is submitted as the approval letter from UoM must be appended to the HMPPS application. 

It is important to note that approval at UoM does not guarantee approval from HMPPS.

If your research is health–related and involves offenders you will require HRA approval.

Confidential Advisory Group (CAG)

Approval from the Confidential Advisory Group (CAG) is needed for studies that require access to identifiable patient data by individuals outside of the direct care team without consent. CAG’s remit extends to England and Wales only. If you plan to access identifiable patient data in Scotland or Northern Ireland you will need to seek guidance from the relevant privacy committee. For all queries related to CAG please email FBMHethics@manchester.ac.uk 

Radioactive Substances

Approval from the Administration of Radioactive Substances Advisory Committee (ARSAC) is needed for studies involving the administration of radioactive substances to participants.

Medicines & Healthcare Products

For all studies relating to clinical trials of medicinal products and medical devices, please see https://www.staffnet.manchester.ac.uk/rbe/ethics-integrity/clinical-trials/

For those working in PS, the subject of ethics may lead you to question whether or not the activities you undertake require ethical review. For clarity, we have provided a list of common activities which do and do not require ethical review.Please note that this list is not comprehensive of all possible activities and when in doubt please first use the Ethics Decision Tool. If after using the tool you still have queries please contact research.ethics@manchester.ac.uk.

Activities which DO NOT Require Ethical Review:

• Surveys or questionnaires which generate anonymous responses and do not contain any personal or sensitive data
• Surveys or questionnaires which generate non-anonymous responses (such as email addresses for follow-up information) but do not contain any other personal or sensitive data
• Service evaluations (i.e. software programmes or training) which generate anonymous responses and do not contain any personal or sensitive data

Activities which DO Require Ethical Review:

• Surveys or questionnaires which generate responses that contain personal or sensitive data
• Surveys or questionnaires which may potentially cause distress in participants
• Testing of products which have a potentially physical effect (i.e. testing of hand soap due to the possibility of allergic reaction

If you are conducting PPIE activity as part of a current or future research project or will be disseminating the result of such activity through an academic journal or publication please consult the Ethics Decision Tool to determine if ethical review is required.

The FBMH Social Responsibility Office can provide support with PPIE activity and have a suite of template documents available, including:

• Privacy notice for PPIE
• Template information sheet
• Template consent form

Please visit their website for more information or email the team at srbmh@manchester.ac.uk

UREC or Division/School Review

Should you need to request an amendment to a previously submitted UREC or Division/School application in which you received favourable ethical opinion, please first read the Guidance on Submitting Amendments

If you decide that your request can be submitted via an amendment (and not via a new application) please complete the following steps:

For projects approved within the ERM system:

• Log into the ERM system: https://submission-ethicalreview.manchester.ac.uk
• Complete an amendment request as detailed in the user guide or Video, being sure to include ALL updated supporting documentation (consent form, PIS, protocol, DMP etc)
• The Research Ethics Team will automatically forward your request to the relevant UREC Secretary or Division/School Chair for action
• You will receive an email with the details of who is handing your amendment request, please communicate with them directly should you have any queries
• You should receive a response within 10 working days of submitting your request

For projects approved outside of ERM

• If your project obtained reearch ethics approval from UoM outside of the ERM system as the project pre-dates the system's introduction, or because you transferred an active project when you joined UoM from another UK university, please contact research.ethics@manchester.ac.uk for advice.

HRA (Health Research Authority) or NHS REC

Should you need to request a substantial amendment to a previously submitted HRA application in which you received favourable ethical opinion, please consult the detailed information found on the Faculty Research Governance Team's website.

HRA (Health Research Authority) AND UREC

Should you need to request an amendment to a study that received approval by both the UREC and the HRA, please complete the following steps:

• Please submit your amendment request to the UREC prior to your amendment being sent to sponsor representative by following the steps as outlined above.
• Once UREC approval is received, forward your UREC approval confirmation, the amendment tool and any track changes documents (as applicable) or new documents (as applicable) to the sponsor's representative for review/authorisation. The amendment review from the sponsor’s representative will consist of checking the tool for any errors and documents for key features/GDPR compliance. Once any changes requested are made, the amendment will be approved for submission to the HRA.
• Once HRA approval is received, ensure that you submit a further UREC amendment if any changes were requested by either the sponsor's representative or the HRA.

Amendments to HRA Approval where a new application has been approved by UREC

In specific circumstances a new UREC approval can be associated with a current HRA approval. This is limited to where UREC have requested a new application is submitted due to the end date of an application passing, and an extension to a current approval is not as deemed viable/appropriate.

In this circumstance once UREC approval has been gained for the study, the study team should send the sponsor’s representative their new/updated documentation along with their amendment tool and UREC approval (updated documentation should include track changes). A cover letter should also be created to be submitted to the HRA to outline the submission and reasoning of any new version 1 documentation where this has replaced previous version 1 documentation.

The sponsor’s representative will review the amendment as a whole and either confirm if the amendment is appropriate to be submitted or confirm if a new HRA application will be required based on the changes, prior to issuing approval of the amendment in line with the process above.

Should you need to report any serious breaches or adverse events that occur during the duration of your study, please refer to the Incident SOP for guidance.

UREC Terms of Reference

Ethics Oversight Committee Terms of Reference 

To help determine if your project requires ethical approval please use the Ethics Decision Tool.

Answers to many common ethics queries can also be found in our FAQ document or in the ERM user guides.

2024/25

Please see below for the dates that the Full UREC Committees are due to meet. Applications are allocated on a first come, first served basis after pre-screening by your Ethics Signatory. For more information on the process of full UREC review, please refer to the relevant sub menu above.

For information on Prop UREC review, which meets throughout the academic year, please refer to the relevant sub menu above.

The next available full UREC Meeting for submitted application consideration is: 20^th November 2024