Apply to the UCL Research Ethics Committee

Understand the steps you need to take when applying to the UCL Research Ethics Committee (UCL REC) for ethical approval.

Depending on whether your project is classed as high or low risk, ethics applications can be submitted for full committee review (high-risk) or for review by the Chair of the Committee (low-risk).

Regardless of which application route you are applying to, all applications are submitted electronically. Your application will need to be submitted as a single pdf document with the electronic signatures of both the Principal Investigator and Head of Department and including any supporting documentation.

Application process

The steps below outline the process of applying to the UCL REC to ensure you follow the requirements relevant to your research project.

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 what their participation entails or the true purpose of the research
• Cover 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 meeting of the UCL REC. The UCL REC meets 10 times a year. The application deadline and meeting dates can be found below.

Low-risk projects
For all other applicants, you should complete the low-risk application form and your application will be reviewed by one or more of our ethics reviewers. Low-risk applications are reviewed on an ongoing basis and so there are no application deadlines for these applications.

2. Register with the UCL Data Protection Office (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 identifiable individual), you must apply for registration with the UCL 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.
 
UCL staff and students can register their research with Data Protection using the online registration form on the DPO website. If you are having issues accessing or using this form, please notify data-protection@ucl.ac.uk. After reviewing your application, the DPO will issue a data protection registration number that you should include in your ethics application.
 
Remember to quote your data protection registration number in 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).
 
If the Data Protection registration process is taking longer than the advertised 10 days, please submit your ethics application form, marking the sections relating to data protection registration as ‘to follow’ or ‘registration in progress’. Once available, please supply the Research Ethics Service with your data protection registration number alongside any changes the DPO advised you to make to data collection and storage arrangements.
 
Remember: data collection must not commence until you have received both ethical approval and data protection registration (where this is required).

3. Register within the Ethics database and download an ethics application 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 UCL email address and set up a separate password for this database. After you have done this, follow the steps for existing users below.

• Ethics database: New User

Existing users
Log into your account using your email address and ethics password and add a ‘new project’ to your account. A 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.

• Ethics Database: Existing Users 

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. 

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 procedures in the first place.

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

Please e-mail UCL Safety Services at safety@ucl.ac.uk if you require further advice.

5. Complete the application form and appendices

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

It is strongly advised that 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. This 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 application and assess the ethical risks and implications of the research.

Please note that for student projects, your supervisor should be identified as the PI, as students 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 not complete these versions. To download the relevant application form see step 3 above.

High-risk 

• High-risk application form (Word)
• Guidelines for completing the high-risk application form (Word)

Low-risk 

• Low-risk application form (Word)
• Guidelines for completing the low-risk application form (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: 

• Template Consent Form (Word)
• Template Participant Information Sheet (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 UCL Interventional Clinical Trials Portal 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, will 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 to ucl.trials.portal@ucl.ac.uk.

Disclosure and Barring Service (DBS) Checks
For research conducted in England and Wales, a criminal 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 on the Disclosure and Barring Service (DBS) Checks website.

It is imperative that researchers to whom this applies take 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 UCL which needs DBS clearance must visit the Student Centre 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 UCL DBS Checks and Criminal Convictions Policy, ‘UCL will accept portability of DBS checks, which individuals may have from previous employers, as proof of satisfactory clearance' under certain conditions. See Section 3.15 of the Policy for details on these conditions. 

For research conducted outside England and Wales, a DBS check would not be applicable if a student is conducting research overseas or in Scotland/Northern Ireland. If a student is conducting research outside of England 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.

• GOV.UK website Criminal records checks for overseas applicants
• Scotland Criminal Records Checks
• Northern Ireland Criminal Records Checks

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.  

Insurance
The insurance for all UCL 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 UCLH/UCL 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 prophylaxis 
• All clinical intervention studies where an inclusion criteria is pregnancy
• All intervention or clinical research studies conducted in the USA and Canada.  

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 the Travel on UCL 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 UCL 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 UCL Ethics Committee if alterations are deemed necessary and desirable to expedite ethics approval
• Departmental endorsement also offers the department the opportunity to recommend to the UCL Ethics Committee that an application be considered as low-risk. 

After you obtain the departmental endorsement and sign off, please submit an authorised electronic copy of your application to ethics@ucl.ac.uk.

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 page for more information.

Application deadlines and meeting dates

Upcoming UCL REC application deadlines and meeting dates:

Deadlines for low-risk reviews

There are no set deadlines for low-risk reviews and so applications can be submitted at any stage. As applications are submitted on a rolling basis it is not possible to provide an estimated response time for the review. It is strongly advised that you submit your application as early as possible to allow sufficient time for the review and any potential revisions required.