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Research ethics

Please note as the University closes for Christmas on Monday 23rd December and reopens on Thursday 2nd January, any emails sent to the research ethics team during this time will not be answered until the New Year.

Please also note that replies to emails sent to the research ethics team between Thursday 19th December and Monday 6th January will be delayed due to the holiday period and limited staff availability.

If you are submitting a UREC application to your ethics signatory for pre-screening please be aware that no screening will take place during the closure period. Please also note that signatories may have limited availability either side of the closure period which will result in a delay to screenings and queries being answered. We recommend speaking with your ethics signatory directly should you have any queries regarding their availability prior to or after the closure period.

**

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:

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) Lynne Barlow Cheetham (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

Bev Haggis

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 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 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 EU/EEA, so the legal basis for collecting and processing data is different. Each country outside the 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 the EEA:
    • A material transfer agreement is in place between the data controller and the University of Manchester and a copy is appended to the application.
    • 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)

  • Research involving relevant material, limited to the secondary use of anonymised tissue samples, previously collected with consent for use in research. 
  • Research involving the analysis of DNA (or RNA), or using the results of DNA analysis from bodily materials, including extraction of DNA (RNA) from acellular materials where the samples have been anonymised, previously collected and with specific consent for DNA (or RNA) analysis in research.
  • Research involving the use of tissue samples that comprise existing holdings that were collected before September 2006.

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.

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.

 

List of Designated Ethics Signatories

 

Faculty

Division/School/Department

Signatory

Contact Email

Humanities

Arts, Language and Culture

Jenny Hughes, Camden Reeves

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

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

Emma Reilly

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

David Blundell, Ian Kinloch

materials.research-ethics@manchester.ac.uk

Science & Engineering

Mathematics

William Lionheart

 

Science & Engineering

Mechanical, Aerospace and Civil Engineering

Partha Mandal, 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

Michael Anderson, Adam Greenstein

CVSethics@manchester.ac.uk 

Biology, Medicine & Health

Cell Matrix Biology & Regenerative Medicine

Tony Freemont, Adam Reid

Email both signatories 

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

Neil Pendleton 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

Sarah Willis, 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, Claire Hargreaves, Sarah Rhodes

pophealthethics@manchester.ac.uk

Biology, Medicine & Health

Psychology & Mental Health

Gillian Haddock, Alison Wearden, Jenny Shaw Email all signatories 

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

Health Research Authority (HRA) Approval including NHS REC

In March 2016, the Health Research Authority (HRA) fully launched the HRA approval process. This streamlined process, which applies to research carried out in the NHS in England, brings together a new process of conducting governance and compliance checks on behalf of NHS organisations (HRA study-wide assessment) with independent NHS REC review (where required). HRA study-wide assessment is carried out by HRA assessors and replaces some of the checks that were previously carried out by individual Trusts as part of the old R&D approval process.

One of the benefits of the new system is that researchers only have to submit one application to the HRA. In most cases, this single application (which requires an IRAS form) will go through NHS REC review and HRA study-wide assessment in parallel. Once the REC approval is in place and all the HRA study-wide assessments have been completed, the study will be issued with HRA approval which means it can go ahead to within NHS sites in England (subject to local agreement).

However, there may be situations where studies only need to go through part of the process or bypass the HRA approval process completely:

  • Example 1 -a study is taking place in a community setting with individuals who are not patients but who do lack capacity to consent. As this study does not involve the NHS, HRA approval is not required but, it does involve adults that lack capacity to consent so there is a legal requirement NHS REC review. The researcher would submit an application to the NHS REC only.  
  • Example 2 - a study was taking place in a hospital but the participants are members of staff recruited within their professional capacity. This would be exempt from REC review (based on the Governance Arrangements for RECs) but would need to have HRA approval (HRA study-wide assessment only). The researcher would submit an application for HRA approval indicating it is exempt from REC review. 
  • Example 3 - a study is taking place in the NHS and involves patients but is being carried out in Wales. The study would require NHS REC review because of patient involvement but, as it is being conducted outside of England, it would not require HRA approval. The researcher would submit an application to the NHS RECs and also to the R&D office for the NHS site. 

You will require HRA approval if:

  • Your research involves the NHS in England

You will require NHS REC approval if your research will involve any of the following:

  • NHS patients, their data or tissues
  • NHS staff where the research is not limited to non-sensitive questions about their personal role
  • Participants who are users of any services for which UK Health Departments are responsible. This includes adult social care in England under certain circumstances; a full list of circumstances that require approval by the National Social Care Research Ethics Committee can be found here
  • Prisoners in the custody of the National Offender Management Service, the Scottish Prison Service or the Northern Ireland Prison Service, where the research is health-related
  • Adult participants who, under the Mental Capacity Act, may lack the capacity to provide informed consent
  • A non-CE marked medical device
  • Exposure to ionising radiation
  • Processing of disclosable protected information on the Register of the Human Fertilisation and Embryology Authority by researchers without consent
  • A clinical trial involving the participation of practicing midwives
  • Participants who are being identified due to their past use of NHS services

Please visit their website for more information on the NHS REC or HRA review/approval process and the additional specific instances in which either NHS REC or HRA approval will be required.

If you are unsure as to whether your research will require approval via the NHS REC or the HRA, please use the HRA Decision Tool. The answer to this tool is definitive and it is strongly recommended that you save a copy of the result for your records.

If you have any additional queries about the specifics of your research project, please use the following contact:

Application Steps

If you have determined that your research requires ethical review and you have determined that this is via the HRA approval process, you will need to submit an IRAS online application to the Health Research Authority (HRA) by completing the following steps:

  • You will first need to create an IRAS account (if you do not have one already) by visiting the IRAS website.
  • Complete the application form for HRA Assessment and Review: one form for all types of review has replaced the older versions of the NHS REC and NHS R&D forms.
  • Submit a copy of the completed application form (unlocked) along with all supporting documentation (research protocol, faculty research approval form/PanMan form and Insurance Assessmentform) to your University Sponsor's Representative:
  • The sponsor will aim to review your application within 10 working days and will liaise with you directly for any suggested clarifications to your documents and will also inform you if UREC approval will be required.
  • The sponsor will then generate your letters of indemnity and insurance that are required attachments to your IRAS application
  • Once all of your documents have been updated and uploaded to the IRAS website, send an electronic authorisation request to your sponsor via the IRAS website.
  • Your sponsor will electronically sign your IRAS form, which can then be submitted via the IRAS portal to request assessment by a HRA Advisor.
  • The HRA Advisor will then be in touch to discuss the progression of your application and any required actions.
  • After assessment, documents are passed directly to the REC for review and approval (if applicable). Additional, if required, the documents must be sent by the CI to the NHS sites for the capacity and capability assessment.
  • Researchers will be given two approval letters: one from the HRA (main approval) and one from the REC. Please ensure sponsors receive a copy of both letters for their records.
  • NHS sites are able to provide confirmation that a study can be undertaken via a capacity and capability assessment, but will not have the authority to provide approval.
  • New required documents include a Statement of Activties and Schedule of Events which will replace the Site Specific Information (to be dissolved in future).
  • For more information about the HRA Approvals Process, see their website.

Useful Documents

The following documents are required when they are being used:

  • Participant information sheet
  • Consent forms
  • Letters to participants/ clinicians/ GPs
  • Adverts/flyers/posters
  • Questionnaires
  • A schedule (i.e. a list of topics) to be discussed at any interview or focus group
  • Ground rules for any meetings or focus groups
  • Distress policy (see here for example)

Reporting the Outcome of an NHS REC Ethical Review

Once you have received final ethical approval from an NHS REC you must submit a copy of the approved documents to FBMHethics@manchester.ac.uk.

NHS Applications - Standard Answers

When completing the IRAS application form, please ensure that you answer the filter questions carefully, as this can result in an incomplete form. 

IRAS e-learning Module

An online module has been added to IRAS to guide new users through IRAS. The module, which is free, explains how IRAS is structured and guides users through how to prepare and make applications using IRAS.  

Questions

A2           Chief Investigator

For student research this should be the supervisor unless it is a PhD student.

A4           Who is the contact on behalf of the Sponsor?

For all correspondence relating to applications:

Lynne MacRae

FBMH Faculty Office

Carys Bannister Building 5.012

University of Manchester

M13 9PL

fbmhsethics@manchester.ac.uk

Tel 0161 275 5436

A36. Storage and use of personal data?

Once the appropriate box(s) have been selected, please also include the following information:      

 “Study data and material may be looked at by individuals from the University of Manchester, from regulatory authorities or from the NHS Trust, for monitoring and auditing purposes and this may well include access to personal information.”

For advice on encryption please view the University Guidance

A43.       How long will personal data be stored or accessed after the study has ended?

Please select 3+ years, and include the following statement:

“Consent forms will be retained as essential documents, but items such as contact details will be deleted as soon as they are no longer needed.”

 A44.       Storage of research data?

Data should be stored in a way that permits a complete retrospective audit if necessary. Unless ethical/professional/local or funding body guidance requires otherwise, research results should be archived in a durable form that is immune to subsequent tampering and falsification for a minimum period of 5 years after the date of any publication which is based upon it. It is recommended good practice that evidence for research based on clinical samples or relating to public health should be retained for 15 to 20 years. Further Information please read the University of Manchester Code of Good Research Conduct

A56.      How have the statistical aspects of the research been reviewed?

THE REC expects for all applications, except those involving qualitative methods only, has the applicant provided details of who has reviewed the statistical aspects of the research?

How does HRA approval fit with UREC approval?

For the majority of research involving human beings, their tissue or data which is carried out on behalf of the University, the University expects it to have gone through a process of ethical review. 

If your study has gone through NHS REC review as part of the HRA approval process or even outside of this process, you don’t need to apply for UREC review; the activities listed in the protocol and IRAS form will be covered by the NHS REC approval and this will satisfy the University’s requirements.

Where your study does not require NHS REC approval, it may need UREC approval to satisfy the University’s requirements. Unless the study was also exempt from UREC, you would need to make an application for UREC review.

If your study does require UREC review but also HRA approval i.e. it is being carried out in the NHS but exempt from NHS REC review, then you will need to the through both review processes. These review processes are independent and each requires a separate application form to be completed. The same core study documents (protocol, information sheets etc.) should be used for both review processes.

Applicants should first go through the UREC process to obtain University ethics approval. During this process, the UREC should be made aware that the application will also require approval from the HRA.

Once UREC approval has been obtained the IRAS HRA approval form should be completed and together with research protocol, UREC approval letter and other supporting documentation, emailed to the following:

    • fbmhethics@manchester.ac.uk for staff/students in the all Faculties

The application will then be reviewed for sponsor’s sign off and the Faculty Governance Office will guide applicants through the rest of the process. Once HRA approval has been successfully obtained, applicants must submit a formal amendment to their approved UREC application in the ERM system which provides the UREC with a copy of all final supporting documents (if these changed during the HRA assessment process) as well as a copy of the HRA approval letter. Once this amendment has been approved by the UREC, applicants must forward a copy of the approval to the sponsor before the green light can be given.

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 letter of ethical approval, complete an IRAS application.

4.    Forward your completed IRAS application form (unlocked), letter of ethical approval from UREC and all supporting documentation (including (research protocol, faculty research approval form/PanMan form, Insurance Assessment form, Statement of Activties and Schedule of Events) to your University Sponsor representative who will aim to review your documentation within one working week.

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 and re-submit for final sign off. 

6.    Once you receive confirmation of sponsor approval, submit for HRA approval via the IRAS system and ensure you send your sponsor representative an electronic authorisation request via IRAS to enable them to sign your form.

7.    Your application will then be sent to one of the HRA advisors for assessment and approval. 

8.    Once you receive confirmation of HRA approval, the documents must be sent by the CI to the NHS sites for the capacity and capability assessment. In addition, copies of the approval letter and confirmations of the capacity and capability assessment should be sent to the sponsor representative for their records. Please note: NHS sites are able to provide confirmation that a study can be undertaken via a capacity and capability assessment, but will not have the authority to provide approval.

9.    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 for your study.

For more information about the HRA Approvals Process, see their 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.

Review and Approval Process for Proportionate or full UREC Review

To Apply for Proportionate or Full University Research Ethics Committee (UREC) Review and Approval

If you have determined that your research requires ethical review (you can verify this using the Ethics Decision Tool)

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

Also if you have determined that this is via UREC then you will need to submit an application by completing the following steps:

  • Log into the Ethical Review Manager (ERM system) and complete a new ethics application. For guidance on ERM system please read our Frequently Asked Questions guide.
  • Ensure you SHARE the ethics application with your supervisor or colleagues to enable them to review the content.
  • Run the completeness checker to ensure all questions on the form are answered.
  • Sign the application form or request the signature of your supervisor or the PI of the project.
  • IMPORTANT: Please ensure you remain logged into the system for at least 60 seconds once you have signed the form to ensure the system recognises the signature. Failure to do this may result in your form not being automatically submitted.
  • Once all signatures have been obtained, the form will automatically submit in the ERM system and you will receive an email confirmation of this.
  • If you have NOT received an email confirmation within 24 hours of signing the form, please contact research.ethics@manchester.ac.uk
  • Your application will be sent to your designated Ethics Sigatory for review (please see the appropriate sub menu for a list of designated Ethics Signatories) and note that this process can take 10 working days and you should plan accordingly for this timeframe.
  • Your signatory may make suggested revisions to your documents that they feel would strengthen your proposal and if this is the case you will be notified via email.
  • Once finalised, your signatory will sign off on your application and submit it to the Research Governance Office for allocation to either the Proportionate Review Committee or the next available UREC committee meeting.

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

For flowcharts of the review and approval processes for UREC, please click on the links below:

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 Support Services April Lockyer
Student Experience Louise Walmsley
Communications and Marketing Janice Ellis
Development and Alumni Relations Alex Gribbin
Social Responsibility Julian Skyrme
Planning Support Helen Barton
Libraries Jan Wilkinson
Manchester Museum Henry Mcghie
Whitworth Art Gallery Esme Ward
Jodrell Bank Teresa Anderson
Teaching and Learning Support Unit Louise Walmsley

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 complete the following steps:

  • Please 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. 
  • Before submitting a substantial amendment to the REC, it must be reviewed by the sponor in order to confirm support of the amendment.
  • Please complete the Notice of Substantial Amendment (NoSA) in IRAS via your original application, providing details of the amendment in the 'summary of changes' section of the form and referencing any relevant sections of the original IRAS form. Please note: you DO NOT need to amend the original application, you simply need to reference the relevant sections in your summary for review by the sponsor and REC
  • Please ensure that any amended documentation has the changes clearly highlighted or in tracked changes. You may wish to include both your original documentation as well as the updated version if there have been a large number of changes. If this is the case, please include a list of all the changes in a separate document for reference and list all attachments under the 'List of enclosed documents' on the NoSA form.
  • After completion, please email the NoSA form to your sponsor for approval.
  • After sponsor approval, the NoSA and updated documentation must be submitted to the REC via the IRAS portal. The REC co-ordinator will be in touch within 5 working days to confirm if the NoSA is deemed to be valid. You should expect a final decision by the REC regarding approval of your requested amendment to take place within 35 days. 
  • All non-substantial amendments must be sent to the Trust R&D for information as well as to the research team for auditing purposes. If your non-substantial amendment is with regard to contact details of the sponsor or sponsors' representative, chief or principal investigator or other study staff, then you must also notify the REC for information purposes. 

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.

UREC Meeting Timetable 2019/2020

ommittee:           

1

Oct 10

Nov 14

Dec 12

Jan 30

Mar 5

May 7

June 11

July 16

 

 

Thursdays at 09.00am

2

Sept 9

Nov 4

Dec 9

Feb 3

Mar 9

April 6

May 11

June 15

 

 

Mondays at 11.00am

3

Sept 18

Oct 23

Nov 27

Feb 12

Mar 18 

May 20

July 1

July 29

 

 

Wednesdays at 12.00pm

4

Sept 25

Oct 30

Dec 4

 

 

 

 

 

 

 

Wednesdays at 12.00pm

5

Sep 30

Nov 18

Jan 20

Feb 24

Mar 30

Apr 27

Jun 1

Jul 6

 

 

Mondays at 12.00pm

 

The next available UREC Meeting for submitted application consideration is: 12th December 2019

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