Complete the following forms:
If relevant, complete:
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.
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.