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Guidance for research and ethical approval in light of the COVID-19 pandemic

Last updated: 27 March 2020     Contact: ethics@ucl.ac.uk

The following advice relates to both staff and student (non-clinical) research that involves human participants and/or their data. This only relates to current, ongoing research, not new applications for ethical approval.  The Decision Tree should assist you as a quick guide. You can also download the full guidance with links.   

Remote Research

Current UCL advice for staff and students who may have concerns and would like advice on the COVID-19 outbreak can be found on the coronavirus advice webpage.

Researchers are advised to consider carefully how best to proceed with their research, on a case by case basis, and where possible, make changes to the research design such that it can be conducted online, rather than face-to-face. You should adjust method, timings and/or responsibilities to enable progress to be maintained. Seek advice from colleagues in your department or faculty. As a reminder, any changes to the intended scope, milestones delivery and delivery date for the project need to be discussed and agreed with the relevant funder and parties. For further advice see the Covid-19 Impact on Research Funding webpage.

Researchers should only consider a postponement to research where absolutely necessary. Discuss this with colleagues before informing your HoD, UCL REC and Research Services should you wish to postpone. Depending on your research, it may also be necessary to inform the funding body of this change.

Masters student research

It is accepted that students undertaking research dissertation projects cannot necessarily postpone their projects and so, if not already done so, students are urgently advised to speak to their supervisor about how to proceed.  This will mean moving to purely online methods (see Guidance to moving to online methods below) or revising the projects to move to a desk-based project instead. Further guidance has been published on the Delivery of Postgraduate Taught and MRes dissertations, projects and placements webpage.

When changing your project, you will still need to consider if the new project requires ethical approval or if it is classed as exempt.  Guidance is available on the Exemptions webpage of the UCL Ethics Website.

Research conducted overseas

For projects that are conducted overseas where the data collection is being done (or will be done) by those already living there (non-UCL collaborators), these studies must follow the local guidance on COVID-19, which may mean postponing the research or revising to online methods.

 

Guidance on postponing research

Should you choose to postpone your research, you need to notify current participants of this. If your research is already underway, for instance, you have recruited participants and they are expecting to take part soon, then please contact them to let them know there may be a delay and/or postponement. If your data collection processes have already been completed, there is no immediate need to contact your participants to advise them of a delay/postponement.

For all research with current UCL ethical approval that is due to expire before 31 December 2020, the approval end date will automatically be extended by 12 months. If you choose to postpone your research, then you will automatically be granted a 12-month approval extension when your work resumes.  Please also advise the UCL Data Protection office that you have postponed your study. You do not need to receive anything back from the data protection office – it is sufficient to have informed them by email at data-protection@ucl.ac.uk.

Guidance on moving to online methods

There are a number of different options available to effectively support research being conducted online and the following provides advice, from a UCL perspective, on various options.  When choosing the most suitable option, you should think about what option may suit your methods best, including matters regarding functionality and stability. Most importantly, online data collection must also be secure.

Options for secure online data collection

The following sections cover getting access to several UCL services which can help you manage your data collection in a secure way.  Undoubtedly, there will also be cases which do not fit well with any of these options.  To obtain advice on any security related concerns, visit the UCL Information Security Group webpages.

Changing to online methods does not mean that you cannot conduct interviews or questionnaires as there are a variety of ways this can be accomplished online.  You will need to update your recruitment documentation so that it refers to the online methods instead. If your data collection is ongoing, contact your participants to advise them of the change and check they are happy to continue with the study. 

Online interviews or focus groups

This can be done via the telephone, or Microsoft Teams (which does allow for non-UCL users to be added), or by using sites such as Skype, WhatsApp or Google Hangouts which all have end to end encryption.  However, UCL’s preference is that you use Microsoft Teams. If you are intending to record the interviews, e.g. via Teams, you must consider how this will be done securely and that the data should remain either within the UK or the EEA. You will need to consult the Privacy Statements and/or Terms and Conditions of the online service you wish to use to ascertain if they are based in these locations or elsewhere.  You must also inform participants that you wish to record the interview – and how – and, as always, gain their consent to do so. When conducting telephone interviews in shared spaces within the home, please be aware of the potential risks to confidentiality this presents and ensure you take steps to reduce these.

If you are new to using Microsoft Teams, then on YouTube there is a comprehensive introductory video available (16 minutes in total).

Online surveys and questionnaires

You may wish to use UCL Opinio, or Microsoft Forms which is included in UCL’s subscription, entirely self-service and simple to use.  Microsoft instructions on how to create a form and do common tasks like attaching a picture or video can be found on the Microsoft Office website

There is also UCL REDcap which is a simple online tool that can also be used to collect data that needs to be stored in the UCL Data Safe Haven. Please be aware that there are two versions of REDCap: if you are working with special category data, you should only use the Data Safe Haven version. The ‘standard’ version is suitable for personal data that is not special category.

If you wish to use other options then you must review the terms and condition and check where the servers are based, and ensure the data is kept within the UK/EEA (see above).

The above options are preferable to using email, as email is not encrypted from end-to-end if sent to, or received from, someone outside UCL.  This makes it possible for someone to intercept, read and even alter email messages and therefore it should be the last choice for sharing anything sensitive. If you do need to use email (e.g. there is no other way of contacting the participant), you should look into whether you can use Microsoft OneDrive to transfer information, rather than by including attachments to the email. For example, you send an email which contains a OneDrive link to information forms, surveys etc.  Please note: This relates to contacting participants, see the guidance below about using OneDrive when sharing data.

Data management and security

When moving to online methods it is essential that you use secure methods and that the data is managed in accordance with data protection law, including GDPR, and that the security arrangements are appropriate to the type of data you are collecting. If this also applies to data obtained under licence (NHS Digital, DfE etc.) you will also need to comply with any restrictions detailed in the data sharing agreement or contract.

Even in these unusual circumstances, information should be stored in a secure UCL location as soon as possible.  If it meets your requirements, Microsoft Teams is the recommended option given its self-service nature. Your S: or N: drive, SharePoint or OneDrive are also possible locations. The Data Safe Haven is an approved location for human participant data.  As with all storage options, you should ensure that only those that need to have access have this granted; e.g. setting up a specific S: drive for the project, or a new Teams channel where only the research team have access, etc.

When sharing data with collaborators, it is recommended that OneDrive is used as the last option, as it may also store a local copy on the machine you use to access OneDrive, which therefore can increase the risk of a breach of confidentiality.

Requesting a new S: drive or SharePoint

If you need a new shared S: drive to store research data, this can be created by raising a ticket via the service desk with Hybrid Infrastructure Services.  SharePoint requires raising a ticket on the Office365 team and as such the self-service alternative of a Teams site might be simpler, as it also allows for inviting non-UCL participants which may be essential for some groups (please see below). When setting up shared drives, please ensure you review access regularly to ensure this is revoked when team members leave.

To raise a service request for a new shared drive (S: drive), then:

  • go to the ISD Help and Support webpage and click on the link to the self-service portal; 
  • in the box self-service requests click on Shared Drive Administration; 
  • fill out the request, making sure to list everyone who will need access and submit the request.

To request a new SharePoint site go to the UCL SharePoint website, read the descriptions of the types of SharePoint sites UCL offers and click to request.  Plear bear in mine, neither the creation of a new S: drive or a new SharePoint is fully automated.  The information you provide is passed to the relevant team for action and this may take some time, especially if many new requests are coming in.

How to amend your ethical approval when moving studies online

For research ethically approved by the NHS, you must follow their guidance for how to amend your ethical approval on the Health Research Authority website.

If you are a new applicant that has submitted a high or low risk ethics application it is likely that you have already been contacted about your research and you should follow the advice provided.

For research that has already been ethically approved at UCL please follow one of the following options.

Option A

If the research involves any of the following, an amendment request should be submitted to demonstrate how any risks posed to participants will continue to be mitigated in an online study:

  1. Methods are intended to evoke behaviour that could be disturbing or cause lasting effects to the participant; 
  2. Methods require physical effort or strain, including the involvement of prolonged or repetitive testing; 
  3. Materials are offensive or distressing, which potentially could evoke difficult emotions (e.g., anxiety, distress or confusion). Note that this includes the use of scales such as the Beck Depression Inventory; 
  4. Materials are mildly emotive (e.g. graphic pictures) or sensitive (e.g., sexual activity, mild violence); 
  5. Includes vulnerable participants; 
  6. Includes participants under the age of 18;
  7. Your application was reviewed by the UCL REC as ‘high risk’.

Please submit your amendment and put ‘Amendment Option A for review’ in the subject of your email. These amendment requests will be reviewed promptly where possible. 

Option B

If the research does not involve any of the above and if the only change to the research is moving the research to online means, and there are no other changes to the research methods, recruitment, or ethical considerations, then provided the online methods adhere to the above guidance, these modifications will be approved. There is no need to seek, or await, any further approval.

Please simply send your answers to the following to your approving REC, i.e. UCL REC, IOE REC or other departmental/faculty ethics committee or representative (and put ‘Amendment Option B for note’ in the subject of the email)

  1. Confirm that this is the only change to the study; 
  2. Confirm that the online methods comply with the information set out in the ‘Guidance on moving to online methods’, and stating how it complies; what online tools are used and where the data is stored; 
  3. Include a copy of the updated information sheet and consent form to be used with participants.

Option C

If any other changes are also being made, submit a full modification request as usual, ensuring that you submit any changes to the application form and supporting documents. Such requests will be reviewed as normal business. Guidance on applying for a modification is available at the end of the Key responsibilities of the Principle Researcher following approval webpage.

Implications for Data Protection Registration when moving research online

A move to online methods as the only change (Options A and B)

For research that has already been registered with the Data Protection Office and where the only change concerned moving participant interactions from face-to-face to online methods an amendment IS NOT REQUIRED.  However, you must inform the data protection office (data-protection@ucl.ac.uk) of your change in order that we have a record.

Please note that such changes would normally require an amendment and will again when this situation has passed.

A substantial change to protocol (Option C)

If there is a substantial change to the protocol* then you must submit a revised form for re-registration or have the revision signed off by the Data Protection Officer.

*A substantial change to protocol might be a change that would alter the level of risk to the participant, i.e. if you are working with vulnerable participants, to do so remotely might remove the safeguard of the researcher being able to detect distress face-to-face and mitigate risk by referring to an appropriately trained person.

Further guidance

Guidance on funding implications is available on the Research Services website.

Guidance for postgraduate research students can be found on the Doctoral School website