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Research ethics

If you have a query that cannot be answered by the online guidance, please refer to the Contacts sub-menu below to see where to direct your query.

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COVID-19: National guidelines from 17th May - please see the updated FAQ for guidance on how this impacts research. 

The University has issued guidance in relation to re-starting research in the COVID environment. The guidance is available in both PDF and Word format. Please ensure you read the guidance carefully and submit any required amendments or applications for approval before beginning recruitment or data collection. Please note, requests to re-start research are subject to the current government guidance and those involving participant travel cannot be approved while travel restrictions are still in place.

Please click on the first two sub menus below for important updates related to COVID-19.

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IMPORTANT: As there are a limited number of full UREC meetings each academic year our office sets an annual deadline for full UREC applications to be received by the research ethics team in order to ensure they are allocated to a Committee before the end of the academic year.

The deadline this academic year will be Wednesday 2nd June by 5pm.

All full UREC applications must be submitted in the ERM online system and be pre-screened by the designated ethics signatory by this date/time in order to guarantee they are allocated to a UREC meeting this academic year. Full UREC applications received by the research ethics team after this date/time will be allocated to the first available Committee meeting but please note we are unable to provide guarantees in relation to timeframe. Depending on the date of submission and the volume of applications this may mean being allocated to a UREC meeting beginning in September 2021.

We would like to stress that we will continue to allocate applications to the first available meeting slot on a first come, first served basis.

Our Proportionate UREC review route will continue to review applications over the summer months and therefore no deadline for submission is necessary. We would strongly encourage applicants to read through the criteria to see if your project could be submitted for proportionate review.

Please ensure you allow sufficient time for the Signatory pre-screening process, which may take up to 10 working days in the first instance and will take longer if you are required to make revisions. Submitting a well prepared application with all necessary supporting documentation included and responding promptly to any feedback from your Signatory will help you progress more smoothly.  

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EU Exit - please see the main Research Governance website for more information.

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Research Ethics is a world-wide set of principles governing the way any research involving interaction between the researcher and other humans or human tissue or data relating to humans, is designed, managed and conducted. Those same principles apply to you the researcher, whether you are an untrained undergraduate or an internationally recognised scholar in your field. 

In order to support the University with regard to Research Ethics, we aim to:

'provide a timely and efficient service that ensures transparent, professional and proportionate ethical review of research, with consistent outcomes.  This is supported by clear, accessible guidance and training for applicants and committees'

For more information on Research Ethics, click on the link below for the appropriate sub-section:

COVID 19 - Important information for UREC studies

National guidelines from 5th January

Please see the updated FAQ for guidance on how this impacts research

COVID-19: Important Information in Relation to Research Ethics Approval of projects requiring UREC approval

For research to be conducted in the NHS, please see the item 'COVID-19 - Important information NHS / HRA studies' below.

An FAQ for general research queries, including guidance on the storage of personal data, can be found on the University's main COVID-19 site

Automatic extension of ’End Dates of Data Collection’ for University approved studies (i.e. those approved via UREC or through a Department/Division/School process)

All studies that have been approved through the ERM system with an ‘End Date of Data Collection’ listed as anytime between the 15th of March 2020 to 15th of March 2021 will automatically have their end date extended to the 30th of September 2021.

The ERM system will still generate Progress/End of Study Report notices according to the original date of ethical approval. If you are still collecting data when completing your Progress/End of Study Report, please indicate when data collection will end and that your study has been granted an automatic extension as outlined above.

Important note for students

This extension ONLY affects the ethical approval for data collection in your study. Submission deadlines for theses and dissertations etc. are set and managed by your study programme and are handled separately by the programme. We recommend that you seek additional clarification and advice from your Programme Director, Tutor or School Administrator if you are uncertain about your submission deadline.

Data Collection for Research

Please note, the position of the University continues to be that all data collection for research projects should be conducted digitally (i.e. Skype, Zoom, Teams, electronic surveys/questionnaires, etc) for the foreseeable future. 

If the nature of your project is such that it requires the use of face-to-face (in person) data collection, please ensure you read the guidance in relation to re-starting research in the COVID environment and submit any required amendments or applications for approval before beginning recruitment or data collection.

A word document version of this guidance is also available.

Meetings of the University Research Ethics Committees (UREC)

Meetings of the University Research Ethics Committees (UREC) will be held via Zoom until further notice. If you have already confirmed your attendance at a future UREC meeting, the Research Ethics team will be in touch with you to make the necessary arrangements for your attendance via Zoom. Please note that Zoom has both audio only and video options and more information on downloading a using Zoom can be found here.  

COVID-19 – Important Information for NHS / HRA studies

For research to be conducted in the NHS, please seek advice from the Faculty Research Governance team (email: FBMHethics@manchester.ac.uk).

 

The Health Research Authority (HRA) has confirmed that it will no longer be reviewing applications for individual UG students and MSc students until further notice. This means no new applications can be submitted for NHS REC, HRA and HCRW Approval (England and Wales) and R&D study-wide review (Scotland and Northern Ireland).

PhD studies will still continue to be accepted, as will projects where UG and MSc students will be contributing to elements of the study but the overall study is being led by an experienced course leader/supervisor with recent and significant experience of approval processes. However, such applications must include assurance in principle from the NHS Trust/CRN that the study is able to proceed.

HRA full guidance: https://www.hra.nhs.uk/planning-and-improving-research/research-planning/student-research/. Included in the guidance are some suggested alternatives to conducting research requiring ethics review.

Types of ethical review and approval

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:

Guidance on applying for Divisional/School review

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

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:

Division/School/Department

Name of Contact

Email Address

Alliance Manchester Business School

  Paul Mcgarry (MSc) Sandra Bundy-Palmer (PGR), Helen Derbyshire (UG)

ethics@mbs.ac.uk

Arts, Languages and Cultures

Jenny Hughes

salc.ethics@manchester.ac.uk

Computer Science

Markel Vigo

ethics@cs.manchester.ac.uk

Environment, Education and Development

Georgia Irving, Liam Grindell

PGR:PGR.ethics.seed@manchester.ac.uk

PGT/UG:Taught.ethics.seed@manchester.ac.uk

Mechanical, Aerospace and Civil Engineering

Clair Gough, William Collinge, Antonino Filippone

MACE.UREC@manchester.ac.uk

Pharmacy

Beckie Davies

pharmacy.ethics@manchester.ac.uk

Psychology Research: Human Communication, Development & Hearing

Jackie O'Brien

HCDHethics@manchester.ac.uk

Psychology Research: Neuroscience & Experimental Psychology

Beth Taylor

dnep.ethics@manchester.ac.uk

Psychology Research: Psychology & Mental Health

Clare Hamnett

Clare.Hamnett@manchester.ac.uk

Social Sciences

Bernadette O'Connor, Amanda Brereton, Amanda Bridgeman 

Soss-Student-EthicalApprovals@manchester.ac.uk

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

Guidance on Applying for Proportionate UREC Review

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

  • **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 require 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)
    • 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 require 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 Skype 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

  • **Will be conducted exclusively inside the UK, EU or in one of the 3 non-EU EEA member countries (Please note: if conducting interviews via telephone or Skype all research participants MUST be inside the UK or EEA or the application will need to be submitted for full UREC review).

Please note: the main reason for requiring full UREC review is that the EU Data Protection Regime does not extend outside the UK/EU/EEA, so the legal basis for collecting and processing data is different. Each country outside the UK/EU/EEA has its own specific data protection laws and regulations and as their requirements may be different, the way decisions are made about handling data can be complex. Other reasons include the specific ethical issues that are raised with overseas research as well as the potential risks to the researcher related to travelling to these destinations.

  • **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).

 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. Please note that the Proportionate UREC Committee or designated Ethics Signatory reserve the right to escalate an application to full UREC review should it be found to be high risk and not adhere to the criteria as outlined above.

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 10 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 UREC Review

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
  • Travelling to locations which are classed as high risk/dangerous either by the University’s Insurance Office or other organisations.

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.

List of Designated Ethics Signatories

Faculty Division/School/Department Signatory Contact Email
Humanities Arts, Language and Culture Jenny Hughes salc.ethics@manchester.ac.uk 
Humanities Environment, Education and Development Graeme Hutcheson, Cecilia Wong, Kate Rowlands, Chris Rees UREC.ethics.seed@manchester.ac.uk
Humanities Alliance Manchester Business School Nadia Papamichail, Julie Froud ethics@mbs.ac.uk
Humanities Social Sciences Claire Alexander (for staff applications), Sophie Woodward (PGR), Mario Pezzino (PGT/UG) soss-research-ethics@manchester.ac.uk 
Science & Engineering Science & Engineering Education Research and Innovation Hub Danielle George  
Science & Engineering Chemical Engineering and Analytical Science Krishna Persuad  
Science & Engineering Chemistry Lucy Valentine chemistryethics@manchester.ac.uk
Science & Engineering Computer Sciences Markel Vigo ethics@cs.manchester.ac.uk 
Science & Engineering Earth and Environmental Sciences David Polya, Clare Robinson, Christopher Knight  
Science & Engineering Electrical and Electronic Engineering David Foster Ethics_Appl_EEE@manchester.ac.uk
Science & Engineering Materials Simeon Gill, Olga Tsigkou, David Blundell, Ian Kinloch materials.research-ethics@manchester.ac.uk
Science & Engineering Mathematics William Lionheart  
Science & Engineering Mechanical, Aerospace and Civil Engineering Bill Collinge, Clair Gough, Antonino Filippone MACE.UREC@manchester.ac.uk
Science & Engineering Physics and Astronomy Sean Freeman, Mark Dickinson PhysEthics@manchester.ac.uk 
Biology, Medicine & Health Cardiovascular Sciences Adam Greenstein CVSethics@manchester.ac.uk 
Biology, Medicine & Health Cell Matrix Biology & Regenerative Medicine Adam Reid  
Biology, Medicine & Health Dentistry Omolade Femi-Ajao, Juliette Kendall dentistryethics@manchester.ac.uk
Biology, Medicine & Health Developmental Biology & Medicine Ian Crocker, Ed Johnstone  
Biology, Medicine & Health Diabetes, Endocrinology & Gastroenterology  John Mclaughlin, Shaheen Hamdy  
Biology, Medicine & Health Evolution & Genomic Sciences Jonathan Codd, Tara Clancy Email both signatories 
Biology, Medicine & Health Human Communication, Development & Hearing Chris Plack, Rebecca Millman, Antje Heinrich   HCDHethics@manchester.ac.uk
Biology, Medicine & Health Infection, Immunity & Respiratory Medicine Rebecca Dearman, Dominik Ruckerl  IIRDethics@manchester.ac.uk
Biology, Medicine & Health Informatics, Imaging & Data Sciences Neil Thacker  
Biology, Medicine & Health Medical Eduction Doug Corfield, Jo Hart Email both signatories
Biology, Medicine & Health Molecular & Cellular Function Contact Head of School of Operations alison.howorth@manchester.ac.uk  
Biology, Medicine & Health Molecular & Clinical Cancer Sciences Mairead Mcnamara, Martin Mccabe  
Biology, Medicine & Health Musculoskeletal & Dermatological Sciences Deborah Symmons, Ian Evans Email both signatories
Biology, Medicine & Health Neuroscience & Experimental Psychology Luca Ticini dnep.ethics@manchester.ac.uk
Biology, Medicine & Health Nursing, Midwifery & Social Work Ann Wakefield, Susan Kirk  nmswethics@manchester.ac.uk
Biology, Medicine & Health Pharmacy & Optometry Ruth Ledder, Denham Phipps (Pharmacy), Philip Morgan, Christine Dickinson (Optometry) Pharmacy: email all signatories, Optometry: email Christine Dickinson
Biology, Medicine & Health Population Health, Health Services Research & Primary Care Christine Greenhalgh, Martie Van Tongeren, Kelly Howells, Sarah Rhodes Email all signatories
Biology, Medicine & Health Psychology & Mental Health Gillian Haddock, Jenny Shaw Email all signatories 
CRUK-MI Cancer Research UK Manchester Institute Caroline Wilkinson  

 

 

 Queries - If you have any queries related to the UREC process please email your Ethics Signatory

Health Research Authority (HRA) Approval including NHS REC

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

How does HRA approval fit with UREC approval?

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.

*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.

External Approvals

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 prisoners, young offenders or HMPPS personnel it will require dual approvals from HMPPS as well as full UREC. Full UREC approval should be obtained before an application to HMPPS as the UREC approval letter must be appended to the HMPPS application.  It is important to note that approval at UREC 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/

Advice for Professional Support Staff

For those working in PSS, 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 your Ethics Signatory.

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

Should you find that your project requires ethical review, please see below for a list of signatories for each area of PSS who will be able to assist you in the UREC process:

Directorate/Office Confirmed Signatory
Compliance and Risk David Barker
Estates and Facilities Jon Ashley
Finance Jonathan Winter
Human Resources Jonathan Winter
IT Services Chris Sharples
Research and Business Engagement  April Lockyer
Student Experience Louise Walmsley
Communications and Marketing Janice Ellis
Development and Alumni Relations Alex Gribbin
Social Responsibility Julian Skyrme
Planning Support  
Libraries  
Manchester Museum Henry Mcghie
Whitworth Art Gallery Esme Ward
Jodrell Bank Teresa Anderson
Teaching and Learning Support Unit Louise Walmsley

Patient and Public Involvement and Engagement (PPIE)

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:

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

Amendments to Ethics Applications

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 Prior to the Launch of ERM (the new online system for ethical review):

  • Log into the ERM system: https://submission-ethicalreview.manchester.ac.uk
  • Complete a historical project form as detailed in the PDF Training Guide or Video
  • Complete an amendment request (for the historical project form) as detailed in the PDF Training Guide or Video, being sure to include ANY updated supporting documentation (consent form, PIS, protocol, etc)
  • The Research Office 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 within ERM (the new online system for ethical review):

  • Log into the ERM system: https://submission-ethicalreview.manchester.ac.uk
  • Complete an amendment request as detailed in the PDF Training Guide or Video, being sure to include ANY updated supporting documentation (consent form, PIS, protocol, etc)
  • The Research Office 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

 

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.

Please also consult the HRA website for information regarding submission of substantial amendments to the REC, including definitions of what constitutes a substantial and non-substantial amendment. 

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 and your sponsor representative at the same time by following the steps as outlined above.
  • Once UREC approval is received and the amendment has been signed off by the sponsor's representative, submit the amendment to the HRA by following the steps as outlined above.
  • 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.

Breaches and Adverse Events

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.

Contacts

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.

Query Contact
Queries on the outcome of the ethics decision tool

Ethics Signatory or School/Division Chair

(see “List of Designated Ethics Signatories” or “Guidance on applying for Division/School review” above)

Progress of a Division/School application

School/Division Administrator

(see “Guidance on applying for Division/School review” above)

Progress of a UREC application

  • If you have not been assigned to Committee: Ethics Signatory
  • If you have been assigned to Committee : UREC Secretary 
Queries relating to the Data Management Plan (DMP), DMPOnline system or data storage researchdata@manchester.ac.uk
Queries relating to data protection, UK GDPR, international data transfer, terms and conditions of websites and acceptability of survey platforms

Information Governance Office information.governance@manchester.ac.uk

Queries relating to contractual arrangements, MTAs, data sharing agreements Contracts Team
Queries relating to HRA approval / NHS REC

Faculty Governance Team FBMHethics@manchester.ac.uk

Technical assistance with ERM that cannot be resolved with the FAQ or user guides

research.ethics@manchester.ac.uk (Please include the project reference number)

Complex queries that cannot be answered by the Ethics Signatory

research.ethics@manchester.ac.uk

Full UREC Meeting Timetable 2020/2021

2020/21

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.

UREC1 Oct 08 Nov 12 Dec 10 Jan 21 Feb 11 Mat 18 Apr 29 Jun 03 Jul 01 Jul 29
UREC2 Sept 07 Oct 19 Nov 16 Jan 18 Feb 22 Mar 22 Apr 12 May 10 Jun 14 Jul 05
UREC3 Sept 16 Oct 28 Nov 25 Jan 13 Feb 03 Mar 03 Mar 24 May 05 Jun 09 Jul 14
UREC5 Sept 28 Nov 09 Dec 07 Jan 11 Feb 01 Mar 15 Apr 19 May 24 Jun 28 Jul 26

The next available full UREC Meeting for submitted application consideration is: 14th June 2021