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UCL Research Ethics

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Applying to the UCL REC

The steps described below outline the process of applying to the UCL REC. Please read all of the steps carefully and ensure that you follow the requirements relevant for your project.

Click the headings to expand and read the guidance.

Step 1: Is your project classed as high or non-high risk?

If your research meets any of the criteria below 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.  There are 10 meetings a year and the application deadline and meeting dates can be found on the applications and meeting dates webpage.

Applications involving the following would be deemed to be high risk:

  • Vulnerable groups Intrusive interventions (including MRI)
  • Overseas clinical trials
  • Sensitive topics
  • 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 participant(s), where the participant(s) would otherwise have a reasonable expectation of privacy (applies both in person and online)

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

See Step 5 below for links to the application form and guidelines for each application route. 

Step 2: Data Protection (if required)

If you are proposing to collect personal data (i.e. data from which a living individual can be identified) you must apply for registration with the UCL Data Protection Officer before you submit your ethics application for review. If the Data Protection Officer advises you to make changes to the way in which you propose to collect and store the data this should be reflected in your ethics application form.

You can register for Data Protection on the UCL Legal Services website by downloading the ‘Research Registration Form’. The form should be completed and e-mailed to: data-protection@ucl.ac.uk. After revieiwng your applicaiton, the Data Protection Team will  issue you with a Data Protection Registration number for your research.  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 UCL Data Protection Office. Note: the Data Protection registration number is not the same as the ethics application number (see Step 3).

To Note: If the Data Protection registration process is taking longer than the advertised 10 days, please go ahead and submit your ethics application form marking the sections relating to Data Protection registration as ‘to follow’ or ‘registration in progress’ to show youhave submitted your application. Once it is available you can supply the ethics team with your DP registration number (together with any changes the Data Protection Office advised you to make to the way in which you propose to store and collect your data for example) so that we can tie up that information with your ethics application.

Remember - data collection cannot commence until you have received both ethical approval and Data Protection Registraiton (where this is required).

Step 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).

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.)

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

Step 4: 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 who should approve it. Please e-mail: safety@ucl.ac.uk if you require further advice.

Step 5: Complete application form and appendices

Complete the application form that is applicable to your research (high or non-high 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 infomation 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 ‘non-high’ risk application forms and application guidance documents for review purposes only. Please do not complete these versions - see Step 3 above.

High risk 

Non-high risk 

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: 

Step 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 (cc.d to ethics@ucl.ac.uk). On 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

A criminal record check will be required by law 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 is available at 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 certificate 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.  

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 (see → UCL JRO):

  • 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 → Travel on UCL business website.

Step 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 which 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 non-high risk. 

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

Step 8: Responsibilities after approval

The Principal Investigator must report any proposed changes, any adverse events and if required report progress on an annual basis.  See the responsibilities after approval webpage for more information.

 

Page last updated: November 2021