Ethical Review Process

Complete the following forms:

• self-assessment form: ethics (SAFE) (Word)

• research protocol template (Word)

If relevant, complete:

• Participant information sheet template (Word)

• Participant consent form (Word)

• Survey (Word)

• 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. For meeting dates and submission deadlines please see our webpage About the St George’s Research Ethics Committee.

If ethics favourable opinion and governance approval is issued, you will be required to submit an annual progress report form (Word) every year the study runs and an end of study notification form (Word) 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 (Word) for approval.

For the annual progress report, end of study notification and amendment application forms, please see below the section of 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.

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 ethics review you don`t 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)

• Application form (IRAS) 

• Study Documentation 

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@sgul.ac.uk

• Job title: Research Development and Governance Manager

• Organisation Name: Joint Research and Enterprise Services, 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. 

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 annual progress report every year the study runs (annual progress report form)
•  and 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.

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.

You should contact Rob Bond in the Biological Research Facility in the first instance, as your project will need to be reviewed by St George's Animal Welfare Ethics Review Body (AWERB).

My project involves research overseas, do I need SGREC favourable ethics opinion and SGUL 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 Penny Lympany.

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 SGUL 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 SGUL 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:

-       HTA Codes of Practice 

-       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.

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.

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 SGUL 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.

•  Survey Monkey

Survey Monkey is a very popular online tool but we do not recommend its use due to data protection concerns.  For staff with a subscription to Survey Monkey it can be used during the academic year 2020/1 as we transition to Jisc Online Surveys as the preferred tool for 2021/2.

•  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

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. This link will take you to the SGUL website that has 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.

St George’s has implemented Microsoft Office 365 Message Encryption (OME), which allows 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.

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 SGUL'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 SGUL 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 SGUL 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:

1. Students can email documents or spreadsheets to each other

2. 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.

3. 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.

The active digital data (ie data that is still being processed) should be stored on a 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 SGUL 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 SGUL Research Data Management Service please contact the Research Data Management Service they will be happy to help you. 

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.

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. St George’s University of London Student Handling NHS Data Policy (pdf)