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Understand the steps you need to take when applying to Ïã¸ÛÁùºÏ²Ê's Research Ethics Committees for ethical approval.

You can submit research ethics applications for review through Ïã¸ÛÁùºÏ²Ê's high and low-risk routes:

• All high-risk research ethics applications must be submitted to the Ïã¸ÛÁùºÏ²Ê Research Ethics Service for review by either the Humanities, Arts and Sciences Research Ethics Committee (HAS REC)Ìýor the Life and Medical Sciences Research Ethics Committee (LMS REC). For further details on our updated governance structure, visit our About the Ïã¸ÛÁùºÏ²ÊÌýResearch Ethics Committee ±è²¹²µ±ð.Ìý
• Low-risk applications canÌýbe submitted to aÌýLocal Research Ethics CommitteeÌý(LREC) orÌýthe Ïã¸ÛÁùºÏ²Ê Research Ethics Service if your department or faculty does not have an LREC.

Guidance on low and high-risk classificationÌýis provided below under Step 1.

This webpage explains how to submit high and low-risk applications to the Ïã¸ÛÁùºÏ²Ê Research Ethics Service. If your department or faculty has established an LREC to review low-risk applications, the application process will differ. Please check localÌýarrangements for submission and review before starting an application.Ìý

When submitting research ethics applications to the Ïã¸ÛÁùºÏ²Ê Research Ethics Service, please provide your application form and supporting documentation as a single pdf document. Your completed application form must include the electronic signatures of the Principal Investigator and Head of Department/Departmental Ethics Lead.

Application process

1. Is your project classed as high or low-risk?

High-risk projects
Applications involving the following would be deemed to be high-risk:

• Vulnerable groups
• Intrusive interventions (including MRI)
• Overseas clinical trials
• Sensitive topics
• A real risk of harm to either participants or researchers
• Scraping data
• Deception, involving actively misinforming or purposefully not fully informing participants about what their participation entails or the true purpose of the research
• Covert methods; actively hiding the observation of, or other data collection from participants, where the participant(s) would otherwise have a reasonable expectation of privacy (applies both in person and online).

If your research meets any of the above criteria it will be classed as high-risk. You will need to complete the high-risk application form and your application will be submitted to a research ethics reviewing committee meeting. The ethics committees meet 10 times a year. The application deadline and meeting dates can be found below.

Low-risk projects
Applications for research projects which do not involve any of the above high-risk elements can be reviewed as 'low-risk'. Please complete theÌýlow-risk application form.Ìý

Low-risk applications submitted to the Ïã¸ÛÁùºÏ²Ê Research Ethics Service are reviewed on a rollingÌýbasis and there are no fixed submissionÌýdeadlines.Ìý

Several departments and faculties have established Local Research Ethics Committees which can review and approve low-risk applications. Please check the arrangements for review within your area before submitting an ethics application.

2. Register with the Ïã¸ÛÁùºÏ²Ê Data Protection OfficeÌý(if required)

If you intend to process any personal data during the course of your research (i.e., information that relates to a directly or indirectly identifiableÌýindividual),Ìýyou must apply for registration with the Ïã¸ÛÁùºÏ²Ê Data Protection Office (DPO) before you submit your ethics application for review. If the DPO advises you to make changes to your data collection and storage arrangements, this should be updated in your ethics application form.
Ìý
Ïã¸ÛÁùºÏ²Ê staff and students can register their research with Data Protection using theÌýÌýon the DPO website. If you are having issues accessing or using this form, please notifyÌý. After reviewing your application, the DPO will issue aÌýdata protection registration numberÌýthat you should include in yourÌýethics application.
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Remember to quote your data protection registration numberÌýin the appropriate section of your ethics application form as evidence that the project has been registered with the DPO. The data protection registration number is not the same as the ethics application number (see Step 3).
Ìý
If the Data Protection registration process is taking longer than the advertised 10 days, pleaseÌýsubmit your ethics application form, marking the sections relating to data protection registration as ‘to follow’ or ‘registration in progress’. Once available, pleaseÌýsupply the Research Ethics ServiceÌýwith yourÌýdata protection registration numberÌýalongsideÌýany changes the DPO advised you to make to data collection and storage arrangements.
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Remember:Ìýdata collection must notÌýcommence until you have received both ethical approval and data protection registration (where this is required).

3. Register within the Ethics database and download an ethicsÌýapplication form

New users
If this is your first application you will need to register your personal details on the Registration Form and a personal account will be established for you. You will need to use your Ïã¸ÛÁùºÏ²Ê email address and set up a separate password for this database. After you have done this, follow the steps for existing users below.

Existing users
Log into your account using your email address and ethics password and add a ‘new project’ to your account.ÌýA unique Project ID for your proposal will be issued immediately which you should make a note of. The finance department will require this Project ID in order to process grant applications based on this research.

Once you have entered your personal and project details, a zip folder will appear containing a ‘low-risk’ and ‘high’ risk application form together with supporting guidelines for you to download to your computer.Ìý

4. Carry out a risk assessment

In order to determine whether there are any risks associated with your research, i.e., risks to yourself as the researcher and to those you are researching, it is important to carry out a risk assessment.

It is a legal requirement that all research is assessed for risk. You should refer to your Departmental arrangements for risk assessment proceduresÌýin the first place.

Alternatively, please refer toÌýÏã¸ÛÁùºÏ²Ê Safety Services guidanceÌýon how to carry out a risk assessment. The guidance includes how to record the assessment and who should approve it.

Please e-mail Ïã¸ÛÁùºÏ²Ê Safety Services atÌýsafety@ucl.ac.ukÌýif you require further advice.

5. Complete theÌýapplication form and appendices

Complete the application form that is applicable to your research (high or low-risk), ensuring that you have read the guidelines and included all appendices and other documents to support your application.

It isÌýstrongly advisedÌýthat you review your application form for any missing information or inconsistencies, particularly in the recruitment documentation, before submission to ensure that all relevant information has been provided, as incomplete applications will be returned for resubmission.ÌýThis can also help to avoid additional delays to the review of your application as it ensures that reviewers have sufficient information to be able to review the applicationÌýand assess the ethical risks and implications of the research.

Please noteÌýthat for student projects, your supervisor should be identified as the PI, asÌýstudents cannot be the PI for ethics purposes.

Below are sample copies of our ‘high’ and 'low’ risk application forms and application guidance documents for review purposes only. Please do notÌýcomplete these versions. To download the relevant application form see step 3 above.

High-riskÌý

• Ìý(Word)
• Ìý(Word)

Low-riskÌý

• (Word)
• Ìý(Word)

Recruitment documents for participants
All studies that involve the recruitment of participants will use recruitment documents such as information sheets and consent forms. See our ‘annotated’ template example forms:Ìý

• Ìý(Word)
• Template Patient Information LeafletÌý(Word)
• Advice on Formulating Participant Information Sheets

6. Related processes

Formal Sponsorship Review for Clinical Trials Conducted in Developing Countries
If your project is an interventional study in a developing country, i.e., a drug, device, or surgery trial then you will need to register your study within the new by completing an Entry Questionnaire (EQ) and emailing a copy to ucl.trials.portal@ucl.ac.uk (copying in ethics@ucl.ac.uk).

Upon receipt of your EQ, the ICTM Portal Review Group, who administer the portal,Ìýwill discuss your EQ and an email response will be sent to you with information on the next steps in the process. General queries/questions regarding the Portal should be directed toÌýucl.trials.portal@ucl.ac.uk.

Disclosure and Barring Service (DBS) Checks
For research conducted in England and Wales, aÌýcriminal record check will be required by law in England and Wales if the research includes working in 'Regulated' activity with vulnerable groups as defined by the Safeguarding Vulnerable Groups Act 2006 or in a position of trust as defined by the Rehabilitation of Offenders Act Exception Order 1975. Further information and advice are available onÌýthe .

It is imperative that researchers to whom this appliesÌýtake action promptly. It can take a month or more to arrange and complete the check, but it is important that researchers have received their clearance before entering a position of trust. Please quote your DBS Disclosure Number in section A2 of the application form.

Current students or those who have applied for a place on a programme at Ïã¸ÛÁùºÏ²Ê which needs DBS clearance must visit the to have their DBS form checked and authorised, and should email studentrecords@ucl.ac.uk for information about this in the first instance.

Staff who need the DBS check as part of their work (for a research project, for example) should contact the Employment Contracts Administration of Human Resources at HR.ECA@ucl.ac.uk for a form to complete to decide what level of certification is required. Once they have seen your completed form and made their decision, you will need to go to HR in person to collect the DBS form itself.

As stated in the Ïã¸ÛÁùºÏ²Ê DBS Checks and Criminal Convictions Policy, ‘Ïã¸ÛÁùºÏ²Ê will accept portability of DBS checks, which individuals may have from previous employers, as proof of satisfactory clearance' under certain conditions.ÌýSee Section 3.15 of the Policy for details on these conditions.Ìý

For research conducted outside England and Wales, aÌýDBS check would not be applicable if a student is conducting research overseas or in Scotland/Northern Ireland. If a student is conducting research outside ofÌýEngland and Wales, they should investigate obtaining a police check for the relevant country.

On the GOV.UK website there is a full list of how to obtain different police checks. It is not always possible for some countries, but it is best practice for students to make every effort to obtain them. There is more information about Scottish police checks on mygov.scot and Northern Irish police checks on nidirect.gov.

If you would like advice on whether you require a DBS, student researchers should email srs-compliance@ucl.ac.uk. For enquiries from staff researchers, please email hr-services@ucl.ac.uk. Ìý

Insurance
The insurance for all Ïã¸ÛÁùºÏ²Ê studies is provided by a commercial insurer. For the majority of studies, the cover is automatic. However, staff or students undertaking the following types of studies will need to complete an insurance form (visit the Ïã¸ÛÁùºÏ²ÊH/Ïã¸ÛÁùºÏ²Ê Joint Research Office website for more information):

• Intervention studies which enrol over 5,000 subjects
• All clinical intervention studies which enrol children aged 5 years and under where the aim is prophylaxisÌý
• All clinical intervention studies where an inclusion criteria is pregnancy
• All intervention or clinical research studies conducted in the USA and Canada. Ìý

Travel Insurance arrangements for students conducting research overseas
An application form will need to be completed so that an insurance cover note can be issued. For further information and guidance please visit theÌýTravel on Ïã¸ÛÁùºÏ²Ê business website.

7. Submit the application

Before you submit your application for review you must ensure that the Principle Investigator and Head of Department (or Departmental Ethics Chair/Lead) have both read and agreed the application and signed the form.

It is important that your application is submitted as a single pdf document that contains the electronic signatures of both the Principal Investigator and Head of Department/Departmental Ethics Lead and includes any supporting documentation, all in one file. Please do not provide a scanned physically signed version as this creates a large pdf document.

Ethical clearance at Ïã¸ÛÁùºÏ²Ê involves a two-stage process
Your completed application should first be submitted for departmental endorsement. Departmental endorsement can be via a departmental Ethics Committe or Ethics Lead or via the Head of Department. Departmental endorsement ensures:

• Awareness by the department of proposals being put forward by departmental staff and students
• Compliance with the Data Protection Act
• Completion of a formal signed Risk Assessment Form
• An opportunity for modification of the ethics application before it reaches the Ïã¸ÛÁùºÏ²Ê Ethics Committee if alterations are deemed necessary
• Departmental endorsement also offers the department the opportunity to recommend to the Ïã¸ÛÁùºÏ²Ê Ethics Committee that an application be considered as low-risk.Ìý

After you obtain the departmental endorsement and sign off, please submit an authorised electronic copy of your application toÌýethics@ucl.ac.uk.ÌýIf you are submitting a high-risk application, please specify in the subject line or body of the email whether it is intended for the LMS or HAS REC.

8. Responsibilities after approval

The Principal Investigator must report any proposed changes, any adverse events and if required report progress on an annual basis. Visit our responsibilities after approval pageÌýfor more information.

Application deadlines and meeting dates

There are no research ethics committee meetings in December or August.ÌýPlease keep this in mind when planning your research; new high risk applications received after the November and July meeting deadlines will not be reviewed untilÌýJanuary/ September.

Summer 2024 update: New low-risk applications received from mid-July to the end ofÌýAugust may have an extended turnaround time for review feedback due to reduced reviewer availability.

2023/24 and 2024/25 Ïã¸ÛÁùºÏ²Ê LMS and HAS REC application deadlines and meeting dates