The process for obtaining research ethics approval varies depending on whether the research is taking place at the Clerkenwell or Tooting Campus.
Clerkenwell Campus Research
How to apply for research ethics approval (Clerkenwell campus)
All research ethics applications based out of the Clerkenwell campus must to be submitted using the City St George’s Research Ethics Online application system. When you sign into the system you will be able to access the full user guide.
You are responsible for ensuring that you obtain the appropriate and required ethical approval before you begin your research and it is important that you consider the ethical implications of your research.
Ethical approval must be obtained before any research involving human participants, identifiable personal data and/or animals is undertaken. Failure to do so may result in disciplinary procedures being instigated and you will not be covered by City St George’s indemnity if you do not have an approval in place. It may also result in a degree not being awarded or the data not being eligible for publication in a peer reviewed journal.
Assessing risk
City Research Ethics Online will automatically establish the risk level of your application and route it to the correct Research Ethics Committee based on the risk. City has three levels of risk: low, medium and high. The applications are reviewed proportionately based on the level of risk of the project.
You should read the guidelines thoroughly in order to prevent unnecessary delay to the approval of your application. The guidelines will provide you with useful tools and processes to consider when you are completing the application form and to point out areas and issues that you should think about, and information you may need to include in the documentation.
This is so that you can plan your project as some Research Ethics Committees meet less frequently than other Committees (for instance Senate Research Ethics Committee). You can also contact the Chair of the Research Ethics Committee in your School/Department at the bottom of this page. For Senate Research Ethics Committee, please refer to the guidance further down this page.
Note that Research Ethics Committees may have different processes for dealing with applications, deadlines and timelines for responding to applications. Please contact the Chair or Secretary of the REC you are submitting to for information. Alternatively, you can see the Research Ethics Committee’s online guidance.
Low risk applications
Applications which are deemed low risk will be reviewed by a proportionate REC in your Department. There is some variation across the institution. Please refer to the guidance provided by your department on how this is dealt with by a local research ethics committee.
For students:
Note that when you submit your application on the system, it will first be sent to your supervisor for comment/review (you may share it with your supervisor before this for comment – to find out how please see the user guide for information).
You can find information of your local REC contact at the bottom of this page.
Medium risk applications
Applications deemed medium risk will be reviewed at a full research ethics committee meeting within the applicant’s Department/School. For submission deadlines, turnaround times and local procedures, please refer to the local research ethics committee guidance.
You can find information of your local REC contact at the bottom of this page.
High risk applications
Regardless of if the applicant is student or staff, or which School /Department the applicant is from, all applications which are deemed high risk will be submitted to Senate Research Ethics Committee. Senate Research Ethics Committee meets 6 times/year (see table to the right).
Applications must be received 10 working days before the meeting date.
Emails outlining the outcome of the applications are sent within 10 working days of the Committee meeting.
You can find information of your local REC contact at the bottom of this page.
More on research ethics approvals (Clerkenwell Campus)
Ethics approval from another institution
If you have obtained ethics approval from another institution, for example if you are transferring a project from a previous place of work/study, you will usually not be required to reapply for ethics approval, but a simpler process ratifying the approval from the other institution will take place. Please note that this is not the same as ethical approval – your response will not be submitted for additional review.
To have an approval from another institution ratified you will need to submit the following information:
- A copy of the approved application from the other institution.
- Evidence that the study has ethics approval (i.e. the approval letter).
- The approved participant information sheet and consent form (note that these may need to be updated to City branding/headed paper should City now be the sponsor of the study).
- You may also have to submit information about the committee that approved the study, especially if it has been approved by a non-UK institution.
You should normally submit your application to the Chair and/or Secretary of your local Research Ethics Committee. However, in cases of high risk/sensitive research where Senate Research Ethics Committee would normally be responsible for reviewing the application you should submit the documentation to researchethics@city.ac.uk.
Note that City does reserve the right not to accept an approval from another institution and you may be asked to submit a new application to one of City’s research ethics committees.
Registering an externally approved City St George's project
Depending on who your participants are and the setting of your research project, you may need to apply for ethics approval from an external research ethics committee. Below is some information about instances when City research ethics committees are unable to review your study.
If your research project does require external approval you will not need to get ethical approval from City. However, you are required to register your project on Research Ethics Online. The registration will also ensure that your study is covered by City’s insurance policy.
Note that only authorised signatories are able to sign off applications to external research ethics committees. Students should note that, in most instances, this does not include their supervisor.
The following are authorised to sign off applications on behalf of City:
- Heads of Departments
- Associate Deans for Research
- Deans of Schools.
You will also need to include a letter from the Sponsor (City) with your application that confirms that City is willing to accept the responsibility of the study. The letter is automatically generated in REO when you register your project and will grant you provisional indemnity. When you have the ethics approval you will need to upload the approval letter. This will generate the final indemnity.
There may be some local variations on the processes outlined above, including authorised signatories.
Contact your local REC for further information.
Retrospective approval
Retrospective approval of research protocols cannot be given. If you collect data before you have gain approval, you will not be able to use that data. Additionally, you will not be covered by City’s indemnity insurance. Failure to obtain approval may also result in disciplinary procedures being instigated.
Other considerations (Clerkenwell Campus)
Conflict of interest
A personal or commercial interest may include, but not limited to:
- Financial gain
- Professional recognition
- Advancing the career or the education or the personal life of a family or friend member, or/and other members of staff or students.
Overall conflict of interest could arise if the researcher has commitment and obligations to another person or body that may appear to act as a potential influence over their independent conduct of research. A conflict of interest could be actual or perceived. They are both equally damaging to the outcome of a decision, therefore treated equal.
Conflict of interest must be declared before the researcher engages in any activity. If that is not possible, any potential conflict of interest must be declared as soon as the researcher becomes aware of such conflict. Applicants must declare any real or perceived conflicts of interest that are relevant to the research project on their application form.
Once the conflict of interest has been declared, each incident must be recorded including a description of how the researcher intends to manage the conflict of interest. The documents must be stored in the departmental shared drive where files can be encrypted with a password. Please note that the Research Ethics Committee may ask you to submit the documentation that shows how you plan to manage the conflict of interest.
A conflict of interest, openly declared and with an agreed process for managing the conflict, is unlikely to be a barrier to receiving ethical approval, provided that you have followed the conflict of interest policy.
Failure to declare a conflict of interest may lead to the refusal of ethical approval. If identified after approval has been given, the Committee must be notified as soon as possible; otherwise ethical approval will be withdrawn.
Please note that conflicts of interest should also be declared in any publications according to the journal’s and publisher’s policy.
Read City's policy on Conflict of Interest for Academic and Research Staff.
Recruiting staff and students for a research project
Projects which involve the recruitment of School staff and/or students require approval by the School you intend to recruit from. This ensures that the same group of staff or students are not repeatedly contacted to become involved in research projects.
Principal investigators should not contact students or staff directly. Approval should be sought from the relevant Dean(s) of School(s), Head(s) of Department(s) and/or Programme Director from which you are recruiting.
Your request should include a brief summary outlining which students or staff you wish to recruit, information of which REC has approved the study and why you are seeking to recruit this particular population, including details of the particular recruitment method.
Note that in some areas of City, permission to recruit staff/students is not needed. For information about the arrangements in your School/Department, please contact your local research ethics committee.
Participant recruitment
Learn how to appropriately recruit participants for a research project. Discover guidelines and templates for participant information forms.
After a research ethics application (Clerkenwell Campus)
Outcomes and appeals
Discover the possible outcomes of a research ethics application and how to begin the appeal process for a denied application.
Modifying an approved application
You will need to apply for an amendment approval if you wish to:
- Change or add a new category of participants;
- Change in the researchers involved in the project, including PI, adding someone on to the project or change of supervisor for student projects;
- Change to the sponsorship/collaboration;
- Add a new or change a territory for international studies;
- Request an extension to your current ethics approval (note that, unless otherwise specified, approval is given for a maximum 3 years, with the possibly to extend the approval for 1 year, twice).
- Change the procedures undertaken by participants, including any change relating to the safety or physical or mental integrity of research participants, or to the risk/benefit assessment for the study or collecting additional types of data from your research participants;
- Change the design and/or methodology of the study, including changing or adding a new research method and/or research instrument;
- Change study documentation such as protocol, participant information sheets, consent forms, questionnaires, letters of invitation, information sheets for relatives or carers;
- Change to the insurance or indemnity arrangements for the study;
- Temporary halt of a study to protect participants from harm or resulting from a concern or complaint made, and the planned restart of a study following a temporary halt (note that this may also require you to complete a Reporting Adverse Events form.
Should you wish to make an amendment to an approved study, you will need submit a completed an 'amendment to protocol' form on Research Ethics Online
The changes may not be initiated without prior review and approval, except where necessary to eliminate apparent immediate hazards to the participants.
Please note that major amendments that alter previous ethical consideration of your project may require submission of a new application to ensure full consideration of the ethical implications of your amendment.
If you wish to amend a project which has ethical approval from an NHS REC you can seek minor amendments from the Chair of the NHS REC that you submitted your application to. Major amendments are likely to require a resubmission. See the Health Research Authority's guidance.
Reporting adverse events or untoward incidents
You will need to submit a form on Research Ethics Online to report any adverse events or untoward incidents occurring during your study in the event of one of the following incidents:
(a) Adverse events
(b) Breaches of confidentiality and/or inappropriate disclosure of personal data under GDPR
(c) Safeguarding issues relating to children and vulnerable adults
(d) Incidents that affect the personal safety of a participant or researcher
Issue (a) should be reported as soon as possible and no later than 5 days after the event. Issues (b), (c) and (d) should be reported immediately.
Where appropriate the researcher should also report adverse events to other relevant institutions such as the police or social services.
Note that in cases of externally approved application (e.g. applications approved by an NHS REC) you are also required to complete and submit this report.
If the adverse effect involves the loss or inappropriate disclosure of personal data, please report immediately as a data breach to the Information Compliance Team via the Information Compliance section of the Service Catalogue.
Under the General Data Protection Regulation (GDPR), City has a statutory obligation to report data breaches to the Information Commissioner’s Office (ICO) within 72 hours.
Further information regarding data breaches is available on the Staff hub.
Senate Research Ethics Committee application process (Clerkenwell Campus)
For enquiries submissions to City St George’s School/Departmental Research Ethics Committees, please refer to the local Committee contact details below.
The Senate Research Ethics Committee (SREC) application process requires that proposals are submitted two weeks in advance of the relevant meeting via Research Ethics Online.
You may be requested to attend the SREC meeting, to explain any issues and answer questions. Please ensure that you keep the date of the meeting you are submitting to free to attend should you be asked to. You will be notified 7 days before the date of the meeting should that be the case. Emails outlining the outcome of the applications are sent within 10 working days of the Committee meeting. If it is a student application, both the student and the supervisor will receive the correspondence.
You are welcome to contact the Research Integrity Manager at least two weeks before the deadline to discuss your protocol/application.
In general research ethics applications are submitted to all members of SREC and considered at a formal meeting of the Committee. However, there are rare instances when an application can be considered virtually, by a sub-committee or by Chair’s action. Please contact researchethics@city.ac.uk should you wish to enquire about submitting an application outside a scheduled meeting. For information about when sub-committees to Senate Research Ethics Committee may consider Chair’s action, please see local procedures.
Chair's action cannot be taken on any research involving:
- children (those under 18)
- those unable to give informed consent
- minority groups
- vulnerable categories
- pregnant women or women in labour
- persons with a physical or mental disability.
For information about amending or extending an approved application see the guidance on Modifying an approved application on this page above.
Dates for SREC applications 2025-26 (Clerkenwell campus)
| Application deadline | Meeting date | Outcome notification |
|---|---|---|
| 01/10/2025 | 15/10/2025 | 29/10/2025 |
| 13/11/2025 | 27/11/2025 | 11/12/2025 |
| 20/01/2026 | 03/02/2026 | 17/02/2026 |
| 05/03/2025 | 18/03/2026 | 01/04/2026 |
| 23/04/2026 | 07/05/2026 | 21/05/2026 |
| 02/06/2026 | 16/06/2026 | 30/06/2026 |
Contacts for application advice (Clerkenwell campus)
In the first instance you will need to follow the guidelines and policies provided by your Department / School. Senate Research Ethics Committee (SREC) will only deal with applications from Schools without local Committees or instances where a local Committee refers an application to Senate Research Ethics Committee in accordance with agreed local policy and procedures.
Note that applications submitted to SREC for convenience (e.g. more suitable deadlines or missing a local deadline) will not be accepted.
Departmental/School Research Ethics Committees
| Committee | Contact(s) |
|---|---|
| Bayes Business School |
Secretary: Claire Molloy Chair: Dr Iqbal Owadally |
| Department of International Politics *see important info below | Dr Konstantin Voessing |
| Department of Journalism | Dr Lindsey Blumell |
| Department of Music | Dr Aaron Einbond |
| Department of Economics | Sotiris Georganas |
| Department of English | Chair: Ed Paleit Deputy: Minna Vuohelainen |
| Department of Sociology and Criminology | Chair: Dr Matt Barnes Deputy-Chair: Dr Ana Gaio |
| School of Health & Medical Sciences | Secretary: Alison Welton School Research Ethics Committee Chair: Dr Nick Drey Department of Health Service Research & Management Chair: Dr Jessie Cooper Department of Language & Communication Science Chair: Ms Lucy Henry Department of Maternal & Child Health Chair: Dr Susan Bradley Department of Optometry & Vision: Dr Michael Powner Department of Nursing: Dr Julie MacLaren Department of Psychology and Neuroscience: Dr Andreas Jarvstad & Dr Lucia Garrido |
| Professor Lorenzo Strigini Dr Martin Nyx Brain (Vice Chair) | |
| Departments of Engineering and Mathematics | Professor Caroline Li |
| Department of Learning Enhancement & Development | Professor Pam Parker |
| The City Law School | Dr Jesse Elvin |
| Senate Research Ethics Committee | Research ethics |
*Department of International Politics: you can submit your applications for ethics approval to the Department of International Politics at any time.
At the departmental level (which is the typical first step in an application), applications will be processed from September 2023 to 15 December 2023, from 8 January 2024 to 5 July 2024 and then again beginning on 2 September 2024.
Make sure to keep this in mind when applying. You should expect at least 4 weeks of processing time before a response from the departmental level.
This does not guarantee approval or a completion of the process. In some cases, approval at the level of the University and additional processing time will be required.
High risk research for students (Clerkenwell campus):
For non-Staff researchers that wish to undertake high risk research, students and their supervisors are advised to read the below policy ahead of submitting an application:
Policy for Undergraduate research projects document.
Tooting Campus Research
All research that is not being reviewed by a nationally recognised Research Ethics Committee (eg: NHS REC), and is being conducted by City St George’s University London students or staff (conducting research as part of their course or job) or research which involves City St George’s University London students, staff, or data, will require a favourable opinion from the St George’s Research Ethics Committee (SGREC) and governance approval by the Research Ethics and Integrity Officer, prior to commencing.
The ethical review process (Tooting campus)
The SGREC processing flowchart will help you to understand the process for gaining SGREC favourable opinion and SGUL sponsor governance approval.
The Research Ethics and Integrity Officer will determine what level of review is required, once the documents/forms have been assessed as acceptable.
How to apply for research ethics approval (Tooting campus)
Low risk applications
Low risk studies are studies, which do not involve any of the high risk elements listed in the SAFE or non-substantial Amendments (a change to the research team or start/end dates), are reviewed by the Research Ethics and Integrity Officer.
Medium risk applications
Proportionate Review is for Medium Risk studies Q3 to Q5 on the Self-assessment form (SAFE). These are reviewed by the Research Ethics and Integrity Officer, Chair and one other member of SGREC.
High risk applications
High Risk Studies are studies, which have been categorised as high risk at validation according to the SAFE risk categorisation checklist (Q6-Q13), will be reviewed by the full SGREC at a meeting to which you will be invited.
Applying for ethical review of your project
Complete the following forms:
If relevant, complete:
Submit all relevant additional documents such as questionnaires, interview schedules, advertisements, agreements with a gatekeeper or other organisation, draft emails for recruitment.
Once completed, submit the SAFE, research protocol and all relevant documents to St George's Research Ethics Committee.
The Research Ethics and Integrity Officer will then review your documents and determine what level of review is required or issue an ethics decision letter. The standard response time is within five - seven working days.
Following your initial submission of the SAFE, protocol and other documents you may be informed that a full ethics application is required for review at a SGREC review meeting (high risk studies).
The St George’s Research Ethics Committee will then review your application at a review meeting to which you will be invited and an ethics decision letter will be issued. The standard response time is within five working days of the meeting. Please note that there is one SGREC Review Meeting each month.
2025/2026 meeting dates
| Meeting Date | Application Submission Deadline |
|---|---|
| Monday 22 September 2025 | Monday 8 September 2025 |
| Thursday 23 October 2025 | Thursday 9 October 2025 |
| Monday 24 November 2025 | Monday 10 November 2025 |
| Thursday 18 December 2025 | Thursday 4 December 2025 |
| Monday 19 January 2026 | Monday 5 January 2026 |
| Thursday 19 February 2026 | Thursday 5 February 2026 |
| Monday 23 March 2026 | Monday 9 March 2026 |
| Thursday 23 April 2026 | Thursday 9 April 2026 |
| Monday 18 May 2026 | Monday 4 May 2026 |
| Thursday 25 June 2026 | Thursday 11 June 2026 |
| Monday 27 July 2026 | Monday 13 July 2026 |
If a favourable ethical opinion and governance approval is issued, you will be required to submit an end of study notification form when the study is finished.
Following approval, if you wish to make changes to your study, including (but not limited to) a change to the research team, study dates, participant documents or study design, you will need to submit an amendment application form for approval.
For the annual progress report, end of study notification and amendment application forms, please see below the section on Running and amending your project.
Please note that we will publish a summary of your research (taken from your application) in our annual report and in other reports that summarise the work of the St George’s Research Ethics Committee and will be publicly available.
For further help completing or submitting these documents please email the Research Ethics and Integrity Officer.
Complete HRA application (if necessary)
Some SGREC studies, such as studies where NHS staff are the participants, may require Health Research Authority (HRA) governance approval.
From 1 September 2021, HRA are introducing new eligibility criteria for student research. Health and social care research applications from students working at undergraduate level are no longer being accepted.
Master's level: Applicants should complete the student research toolkit to check eligibility.
Doctorate level: Applicants are eligible to complete health and social care research.
If you can apply for SGREC ethical review you will not need NHS REC as well. Please ensure that this is indicated on the IRAS form. (IRAS Q46 Does your study require REC Review? - You should reply NO)
Insurance
Example for Organisation Information Document Non-Commercial
Example for IRAS schedule of events
Sponsor details:
- Name: Georgia Bullock
- Telephone number: +442087255013
- Email Address: gbullock@citystgeorges.ac.uk
- Job title: Research Development and Governance Manager
- Organisation Name: Joint Research and Enterprise Services, City St George’s University of London and St George’s University Hospitals NHS Foundation Trust
Student projects also require electronic sign-off by the student’s supervisor.
Please send the PDF form of the IRAS application and the documents to the Research Ethics and Integrity Officer for checking before the submission to the HRA.
Running and amending your project
As part of the terms of your favourable ethics opinion and governance approval you will be required to submit:
- an end of study notification when the study is finished (end of study notification form)
- an amendment application (amendment application form) for any changes to your study, including (but not limited to) change of research team, study dates, participant documents or study design. Update your approved application with documents, using ‘track changes’. Formatting changes do not need to be tracked. The Research Ethics and Integrity Officer will then review your documents and determine what level of review is required or issue an ethics decision letter. The standard response time is within five working days. Please note that amendment applications must be approved before changes are implemented.
All documents need to be submitted by email to SGREC.
Please note that Annual Progress Reports no longer need to be submitted to the SGREC, in line with the updated requirements for NHS RECs.
Frequently asked questions
If you have any questions, please email the Research Ethics and Integrity Officer.
Read our frequently asked questions for further help and guidance with your application.
Must the SAFE be signed off my supervisor?
Yes, this is to ensure that your supervisor has oversight of your study and approves of your research proposal.
Supervisor sign-off is part of the SAFE approval process. You must submit your SAFE, protocol and all other relevant documents to the Research Ethics and Integrity Officer.
My research is being conducted on animals. Do I still need to gain favourable opinion from the SGREC?
No, SGREC does not consider animal-related research projects.
Our Biological Research Facility (BRF) is temporarily closed for refurbishment. When it reopens, it will once again be at the heart of our commitment to carry out animal research only to the highest possible welfare standards.
My project involves research overseas, do I need SGREC favourable ethics opinion and CSGUL governance approval?
If you are a University employee and you will be the Principal Investigator or the University will be the Sponsor of the project, you need to submit the application to SGREC. The Ethics Committee will consider the general ethical aspect of your project and it will review your safety, the insurance cover and reputational risk to the University.
Research projects must comply with the UK’s legal requirements and the University`s ethical requirements, as well as the laws and regulations of the country where the study is taking place or where the data will be collected. You must seek local ethics favourable opinion and sponsor governance approval from the organisation(s) where the research is taking place and any other local/national approvals required by that organisation and country. Evidence of these approvals must be provided to the SGREC.
If you are travelling abroad you should ensure travel insurance is in place.
If your research involves human tissue from overseas, you need to follow the Human Tissue Authority (HTA) regulation of the import/export of human tissue for research purposes. Even for countries that do not regulate human tissue research, as a minimum you will be expected to seek assurances from the host institute that the material is ethically sourced and check the consent if you will use identifiable samples.
If my research involves the use of ionising radiation can I apply for SGREC?
No. For UK studies which involve ionising radiation will need to go via the IRAS process. For more information about ethics review for ionising radiation
If my research involves the recruitment of participants who lack capacity can I apply for SGREC?
No. For UK studies which involve the recruitment of participants who lack capacity you will need to go via the IRAS process. For more information about ethics review for participants who lack capacity
My project will involve taking human tissue samples. What approvals do I require?
Ensure that your project/collection is informed and that both research ethics and the Human Tissue Act designated individual (DI), Dr Priya Madhou, or Person Designated (PD) Ash Sameja & Lara Painter.
Registration / Application for ethics opinion you need submit:
- Study protocol: what samples are collected or stored; where will the samples be stored; samples are anonymised or are identifiable; what research is planned; what will happen if any are left after the research; what HTA training the researcher has received
- Material Transfer Agreement (MTA) if applicable
- Favourable ethics opinion and study protocol (translated to English)
If research involves the use and storage of human tissue (relevant material), ethical approval and R&D registration must be obtained to ensure that your work complies with the Human Tissue Act 2004.
For information regarding the documentation process of human tissue at CSGUL please go to the relevant section.
Research on human samples requires ethical approval and requires the patient's consent.
Ethics opinion from NHS REC:
- Research involving volunteers who are NHS patients
- The collection of tissue from NHS patients
- The use of previously collected tissue from which past or present NHS patients could be identified
- To store or use the tissue of a living or deceased person for a research project on premises without a licence from the HTA
- To store or use tissue from the living for a research project without consent where the samples are anonymised to the researcher
- To analyse human DNA in material from the body of a living person (or using the results of DNA analysis) without consent, in circumstances where the researcher is unable to identify the tissue donor and not likely to be able to do so in the future
- To store or use tissue for a research project where consent is required and the tissue is from adults unable to consent for themselves
- To export tissue from the living and there is no consent in place for use in future research
Ethical opinion can be obtained from SGREC:
- Research involving volunteers who are not NHS patients
- The material has been transferred to CSGUL from outside of the organisation (UK or outside of UK) for the purposes of research without valid research ethics opinion
- Access to human tissue from a HTA-licensed Biobank without ethical approval for use in research
Any tissue approved for such studies must be stored in an HTA-licenced premises.
R &D registration:
- Research project with human tissue from an HTA-licensed Biobank with generic ethical approval for use of the tissue in research
- Research limited to secondary use of tissue samples previously collected, in the course of normal care, with consent for research and the patients or service users are not identifiable to the research team
All staff working with human tissue under the University's Research Licence and those who may wish to retain tissue at the end of an ethically approved research project must comply with:
- University policies and procedures for the management of human tissue samples for research
- Undertake the MRC human tissue e-learning training, once you are on the page choose Research and Human Tissue Legislation - updated.
How often are the SGREC meetings? When I should submit my application?
The Committee has scheduled meetings almost every month but will only meet if there are applications to review that month. All deadlines are at 4pm, and are usually a minimum of 2 weeks before the committee meeting date.
The dates below only apply to applications that require full committee review but we advise you submit all applications for ethical review well in advance of these deadlines. This will make sure your application can be reviewed in time to be included in the papers for the next meeting.
Do I need HRA approval if I want to recruit participants working for the NHS?
If you (SGUL/NHS Trust staff/student) will recruit participants (working for the NHS) through advertising on a professional organisation website you do not need HRA approval, but you still need SGREC favourable ethics opinion for your research project.
If you will recruit via their NHS working team e.g. a hospital ward then you do need to go through the HRA.
When will I need gatekeeper approval?
If you are conducting research outside the University it is good practice to obtain the written consent of any organisation that agrees to host your study. You need to submit an email or letter from the person who has research authority at the organisation. For NHS research you will need approval from the R&D Office of the NHS Trust involved.
When do I need to complete the notice of amendment form?
If you wish to amend your study after approval, you will need to submit an amendment form along with any updated/amended documents. Some examples of when you will need to submit an amendment are:
- a change to the study population
- a change to the research team
- a change to the recruitment strategy
- a change to the research methods / study design
- any changes to the study outcomes
- a change to any participant documents or the protocol
- a change to the end date of the study.
Please see the Running and Amending Your Project section for more information and contact the Research Ethics and Integrity Officer if you need advice on amending your study
Who can I contact if I have a query regarding the application form?
Please contact the Research Ethics and Integrity Officer to discuss any queries you have. Please consider the Drop-in sessions in the Library or onlime (Microsoft Teams).
If you would like to ask a question that is not addressed on this page, please contact the Research Ethics and Integrity Officer.
Advice and resources (Tooting campus)
Version control
The sponsor logo should be in the header and the study title, version number and date should be in the footer of the document. Please use the templates available.
You must exercise appropriate version control over your documents. The final version of the documents that you submit to the SGREC should be version 1 and must be dated.
If you do not include these details on your documents, the Research Ethics and Integrity Officer will return them to you and ask you to complete them.
If you are given provisional favourable ethics opinion by SGREC or otherwise asked to make changes to your documents, you must ensure that you update the version numbers and dates of those documents accordingly. After a change, this would become version 2.0, version 3.0 etc.
Using online surveys / questionnaire tools
For studies taking place on the internet (eg an electronic survey) the Participant Information Sheet could be combined with the consent form (Survey template).
The information provided prior to the consent statement should include details:
- Introduction of you
- What is the research about?
- What will happen to me if I take part?
- Why have I been asked to participate?
- What data will be collected?
- What are the possible benefits of taking part?
- Are there any risks involved?
- What will happen to the data which will be collected?
- Do I have to take part?
- Can I change my mind?
- Where can I get more information?
Most online survey software have an option to allow participants to continue with the survey only if they tick a box to indicate their consent. This tick box should be every page of the survey.
Survey Tools:
- Microsoft Forms
You can access Microsoft Forms via the CSGUL O365 Portal by going to and clicking on the Forms icon.
Help and tips on how to create a survey using Microsoft Forms. For further help please email.
Please make sure you refer to any other relevant guidance before setting up your survey, for example in terms of either data protection or research ethics requirements. Please use the Data protection and managment guidance.
- JISC Online Surveys
Where Microsoft Forms does not provide the necessary functionality for your needs, it may be possible to use JISC Online Surveys instead. For further information and to request access to Online Surveys please email the Learning & Development Manager
Audio recordings of interviews
You should state clearly on the Participant Information Sheet (PIS) and Consent form if you intend to use an audio or video recorder on the interview. You should make it clear whether the recordings are optional or required for participation. Audio / visual recordings should be held on a password-protected recording device or in an encrypted University file until the transcription has been completed. After transcription, the recording should be destroyed, and the transcript stored in a password-protected University file. After the anonymisation of the transcripts, the participant will not able to withdraw their data. You need to indicate in the PIS the time limit for withdrawal of data (Please use the PIS template (Word). The transcript should be made available to the participant at their request.
Recommended tools for interview are MS Team.
MS Teams as the best option for remote interviews moving forward. It keeps the organisational advice about systems consistent. Our website contains Training guides on MS Teams.
There is advice for students about the use of Teams in the Learning Technology Quick Guide for Students on Canvas
Webcams can be turned off to prevent recording of video. You must make it clear to the interviewee what the process is, before the recording part starts.
City St George’s has implemented Microsoft Office 365 Message Encryption (OME), which allows City St George's, University of London staff and students to send encrypted email messages both to colleagues within the University and to recipients outside the organisation. Microsoft OME is available in both the Outlook Web-based Application (OWA) and the Outlook Desktop Client.
Microsoft OME can be used to protect personal data when sending it via email, and includes options to restrict what the recipient can do with that email, e. g. prevent them from forwarding it to anyone else. It will also protect email attachments where the files have been created using Microsoft Office applications, e. g. Word, Excel, PowerPoint.
Files containing sensitive personal data (also known as special category data) should always have additional protection applied before they are sent as attachments to email. 7-Zip can be used to encrypt and password protect documents containing sensitive personal data or files in non-Microsoft Office formats, such as PDFs or image files. Passwords to open protected files should never be shared in the same email used to send the file.
Training for using Microsoft OME, including definitions of the different levels of encryption, can be booked from the Library's training pages.
For further help with using encryption or queries regarding access to 7-Zip please email the IT team.
Please note that if audio recordings are being sent to a third party transcriber, the transcriber preferably UK-based to comply with data protection law in the UK. The format of the data (such as the data will be anonymised, encrypted) should be clearly stated in the study protocol and PIS.
Data management for undergraduate & MSc students
Details on data storage must be included in the study protocol and Participant Information Sheet (PIS).
You have access to two data storage areas:
- OneDrive for Business on CSGUL's Office 365
- Personal SGUL H: drive
Whilst you are working on or with their projects/data, they can use these two areas to save work – this should give them the freedom to work on their data on personal laptops. The H: drive is accessible remotely via VPN, and ensures data is secure both from a confidentiality and loss perspective. You can access OneDrive directly from their student mailboxes by clicking ‘Office 365' on the top left of the screen. You have 1TB of cloud storage available on OneDrive.
You need to ensure that their research data/files are saved on their H: drive or OneDrive for Business accounts and NOT on personal laptops, removable hard drives or other portable media, or personal cloud-based services (e.g. smartphones back-up etc.). The CSGUL H: drive that every SGUL student is given is backed up to a server every night so data is recoverable. Any files containing personal data must be encrypted/password-protected.
Information on OneDrive/Office 365 is automatically saved and backed up. OneDrive for Business is better for anonymised data and collaboration.
The only people able to access files on OneDrive for Business are the owner of the account or named members of their research team they choose to share files with. It is important that data is anonymised before it can be put on OneDrive. No sensitive personal data or patient information should be kept on the university's 365 cloud, including OneDrive for Business, at any time.
Removable media: these include audio recorders and USB devices. If you are collecting data in the field, you can store your data temporarily on removable storage as long as it is password-protected and encrypted. You need to use bit locker for the encryption to able to work on CSGUL systems. Data on audio recorders must be kept in a locked, safe place and should be password-protected if your device has this feature. Data should be stored in the device’s physical memory and not on the cloud. Saving identifiable or sensitive research data on the cloud is not permitted under any circumstance. Note that your data is still vulnerable if the removable device is lost or stolen. Ensure that you upload the information to your H: Drive or, if anonymised, OneDrive as soon as possible and delete all information held on the removable drive.
Students sharing data between each other:
- Students can email documents or spreadsheets to each other
- If the document/spreadsheet contains any personal data, the document will need to be password-protected and then sent, with the password for opening the file sent separately.
- If the document contains no personal/sensitive data you can share it directly on Office 365 using OneDrive's sharing and collaboration features.
Support/training with Office 365 is available from our IT Training Manager.
Signed consent forms and other hard data must be stored securely in a lockable cabinet. If the documents are scanned, the originals must be disposed of as confidential waste (blue bin at the University). The scanned copies must be saved in a secure, password-protected University file.
Data management for PhD students
The active digital data (ie data that is still being processed) should be stored on a City St George’s University of London network or shared drive, which you will be allocated by Computing Services. As your project develops, you might find you need more storage space. Email the IT/AV team to discuss your needs for more active data storage.
Information on OneDrive/Office 365 is automatically saved and backed up. All network drives, including the SGUL H: drive is backed up to hard disk and then cloned to tape storage server every night. Full backups of all the data are carried out monthly.
The data from the removable media (e. g. data collected from a field site) needs to be moved to City St George's servers for active/long term storage. Please see the SGUL Removable Media policy.
The physical/hard copy data should be stored in securely in locked cabinet (both in the field – if applicable – and for active and long-term storage).
Plans for the retention and/or preservation of the data also need to be specified in the study protocol. You need to identify the strategy for preserving the data during the retention period, including how long and where it will be stored and who will be responsible for the data during this period.
Any plans for data sharing should also be mentioned – with permission to share the data addressed in PIS and Consent form (this is already be included in the existing templates).
The research team should address data quality (identify their quality assurance procedures) and their data organisation and documentation strategy in the data management section of the study protocol. It is an online system that you can use to manage data management plans as part of grant applications.
For more general information/education on data storage you can check the UK Data Service guidance on storing data or SGUL-specific guidance
Data management advice for staff is provided by the City St George's Research Data Management Service please contact the Research Data Management Service they will be happy to help you.
Data retention
You need to give details on the retention of the following data in the study protocol (SP) and Participant Information Sheet (PIS):
- Personal data
- Participant`s contact details
- Signed consent form
- Transcripts
- Research data
Personal data, participant`s contact details
Personal data such as a participant`s contact details should be kept securely and for as short a period as possible. The data should be securely destroyed/deleted no later than at the point when you do not need to identify the participants anymore (e.g. after data has been cleaned/prepared for analysis and you don`t need to contact the participants anymore).
Consent form
Consent forms and other hard data must be stored in a lockable cabinet. If you scanned the documents, the originals must be destroyed as confidential waste (blue bin at the University). The student’s supervisor (not the student) is responsible for the storage for student projects. The consent forms should be kept as long as the research data.
Transcripts
Any audio recording should be destroyed as soon as it has been transcribed. The transcripts should be kept as long as the anonymised research data.
Research data
All research data should be securely held for minimum 5 years after the study has finished. The student’s supervisor (not the student) will hold the responsibility for the data retention and disposal for student projects during this time.
Student Research
The student research projects` data retention is the Supervisor responsibility.
NHS data management for audits/service evaluations
Audits/service evaluations conducted by students should only be conducted using anonymised patient data. Please complete the NHS Digital Data Security Awareness Level 1 training
According to the HRA regulation from 1 September 2021, undergraduate student cannot do research with NHS staff.
1.The HRA decision tool to determinate if the project is research or not
2. Registration by JRES (sgulREC@sgul.ac.uk):
- SAFE form
- Study protocol
It should state clearly from the beginning of the application this is a service evaluation or audit. What service will be evaluated? Audit – what standard will be compared?
3. The project will need approval from the clinical lead in the department and should also register with the clinical audit team/R&D at the Trust where there are accessing the data.
4. City St George’s University of London Student Handling NHS Data Policy