COVID-19: CUREC guidance on research involving human participants

Research involving in-person interactions with research participants during national lockdown

In view of the latest national lockdown, departments should (i) review their portfolio of active research studies conducted in the UK which involve in-person interactions with research participants and (ii) establish whether such in-person research is crucial during this period. Crucial could be interpreted in terms of, for example, research importance, scientific priority, or direct clinical benefit. It should also be considered in the context of the importance of the in-person interaction to the delivery of the research project and the overall risk profile of participants.

Only such studies which are judged to be crucial should be permitted to proceed during this period and on condition that the research can be conducted in a COVID-secure way. Where possible, during the period of national lockdown, research involving human participants should be conducted online or remotely. If this is not possible and research has to be paused, there is no need to notify the ethics committee that approved the research.

Please note that Oxford University Hospitals (OUH) has now paused all new clinical research activities in order to reduce the number of hospital visits and clinical interactions between staff and research participants. OUH will continue to support COVID-19 research studies (including designated Urgent Public Health studies) and clinical studies that involve delivery of ongoing clinical care.

 

The health, welfare and safety of students and staff is the number one priority for the University. We also have a duty to protect members of the public who participate in our research, and research partners and collaborators outside the University. Research must be conducted in accordance with current government and local restrictions. The University's health guidance should also be followed. Researchers should continually review and update their ethics applications and risk assessments so they are in line with government and University guidance.

Research staff and students should also consult: 

  • the University's updates and guidance from their department 
  • the Safety Office’s guidance on UK and international fieldwork, and specific requirements for appropriate risk assessment (in particular the management of risk specifically related to the COVID-19 situation)

Separate guidance on UK-based clinical research is available on the COVID-19 guidance from Research Services page.

FAQs for research reviewed and approved by CUREC

Research reviewed by the Medical Sciences Interdivisional Research Ethics Committee (MS IDREC), the Social Sciences and Humanities Interdivisional Research Ethics Committee (SSH IDREC), the Oxford Tropical Research Ethics Committee (OxTREC) and departmental research ethics committees (DRECs)

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Researchers should continually review and update their ethics applications and risk assessments so they are in line with government and University guidance. 

Research staff and students should also consult: 

  • the University's updates and guidance from their department 
  • the Safety Office’s guidance on UK and international fieldwork, and specific requirements for appropriate risk assessment (in particular the management of risk specifically related to the COVID-19 situation)

For information about conducting research in departments that have reopened, please see question 6.

Separate guidance on clinical research is available on the COVID-19 guidance from Research Services page.

 

For research involving online surveys please read the CUREC Best practice guidance for internet-based research (BPG06). Researchers should adapt the template information sheet for surveys to prepare a survey introduction to provide participants with the information they need to make an informed decision about participating, rather than having separate information sheets and consent forms.

Please note that the University recommends use of JISC Online Surveys, Microsoft Forms (Nexus 365 version) or Qualtrics, which are compliant with UK data protection laws – see the IT help website for more information. Oxford University staff and students can get a free JISC Online Surveys account by emailing help@it.ox.ac.uk

JISC surveys are automatically set up not to track IP addresses (this needs to be turned off in Qualtrics by the researchers), which guarantees better anonymity to participants.

 

Consider whether you need to make any changes to your recruitment strategy, how you approach potential participants or to your process for obtaining informed consent. How will you record the participants’ consent? Guidance and templates are available on our Informed consent page. You may find it helpful to refer to CUREC’s Best practice guidance on conducting research interviews which includes guidance on conducting interviews remotely.

The procedures for obtaining the participants’ informed consent should be proportionate to the nature of participation and the risks involved. For example, audio-recorded verbal consent may be suitable if the project is deemed to be low risk. It is also important that consent should be documented in an auditable record and stored securely

Are there any risks associated with where the participants are located for the interviews? For example, are they in a safe place or could they be overheard? Who could be captured in the background if video is required? Consider any additional communication challenges. It might be harder to tell if a participant needs a break or is upset when conducting interviews remotely. 

If you will be making audio or video recordings or capturing images, familiarise yourself with the University’s research data management guidance and policies. Microsoft Teams is the University’s preferred platform for conducting interviews remotely. 

University guidance on platforms for conducting research remotely:

 

Research in the UK must comply with government guidance and should only be conducted in person if it is safe to do so.

Researchers need to be aware that UK and overseas rules and guidance will be subject to change. Any in-person research approved by a University ethics committee may need to be amended or paused to comply with amended guidance. 

Risks to health, welfare and safety of the research participants, researchers and other people involved in research involving fieldwork must be addressed before the research is carried out. Research staff and students should also consult the University's updates and follow guidance from their department. 

A risk assessment will need to be conducted for any in-person research (including for research involving fieldwork within the UK). A risk assessment proforma should be available from your department or faculty. If not, please use the form available from the Safety Office's Overseas travel and fieldwork webpage or refer to the Safety Office's guidance or Risk assessment webpage for further guidance. Any risk assessment will need to specify how risks related to COVID-19 will be managed. A risk assessment will also be needed if local researchers are going to conduct research on behalf of University of Oxford researchers.

It is important also to consider these risks in terms of the following:

  • type of participant (for example child, adult, those considered vulnerable to COVID-19, elderly)
  • location of research (for example country, University-owned space, schools, public spaces)
  • type of contact required with participants (for example whether social distancing is possible or if close contact is required, such as for fitting equipment for brain imaging procedures, or being in a confined space with inadequate ventilation)

Applications for ethics review of research involving in-person contact with human participants must be accompanied by an authorised risk assessment (see the Safety Office's guidance) and endorsement from the head of the relevant department or faculty.

The ethics application should also include details of how any risks to the researchers, research participants or other people involved in the research will be addressed. 

The extent of any in-person contact and the measures taken by the research team to reduce the risk of transmission of COVID-19 must be explained to participants in advance in order to inform decisions about participating. 

Please note the following requirement for research reviewed and approved by OxTREC, for studies where it was necessary to arrange additional territory-specific insurance. If it becomes necessary to suspend such research, please notify the University’s Risk and Insurance team (via research.insurance@admin.ox.ac.uk). This will enable them to liaise with the insurer to facilitate, where possible, an extension or temporary suspension of the bespoke insurance.

 

University staff and students who conduct research with human participants and personal data sometimes engage third party individuals or companies to provide research assistance. This assistance can take the form of, for example, providing interpreting, translation or transcription services or assistance with interviewing or surveying participants in fieldwork in the UK and overseas.

While the coronavirus pandemic is ongoing, careful consideration should be given as to what form of in-person third-party assistance is appropriate and reasonable.

Researchers and reviewers should consider:

  1. Is it necessary or appropriate to conduct the research in-person during the pandemic? Could the research be conducted remotely, online or postponed?
  2. What are the reasons for outsourcing the in-person interaction?
  3. What is the local COVID-19 situation (including current rates of transmission)? Is what is proposed in line with current local government guidance?
  4. Would it be safe for anyone to conduct the research? Will those conducting the in-person research be subject to risks that would be unacceptable for a University of Oxford researcher?
  5. Has a COVID-19 risk assessment been conducted for the in-person element? This needs to explain:
    1. the measures necessary to protect against COVID-19
    2. the support being provided to the local workers
      The researchers may find it helpful to seek advice from a safety officer.
  6. Is the research being conducted in accordance with CUREC’s Best Practice Guidance 01 on Researcher Safety (including providing training, ongoing support, appropriate remuneration, insurance and acknowledgement)?

 

It is essential that any on-site research work is considered by each department in relation to its overall assessment of risk. The guidance below currently applies only to departments within the Medical Sciences Division and where the research cannot be conducted remotely. 

When considering research on site, researchers are required to complete the following before approaching CUREC:

  1. Where University space is required, ensure that the head of administration and finance (HAF) of the department has confirmed that the study may resume activity, with full consideration having been given to Safety, Estates, HR and IT support, and that the (re)opening of said study is consistent with the current return to on-site working status, including that the building is open.
  2. Read departmental return to on-site working (RTOSW) risk assessments relating to specific buildings or research procedures, and to the COVID-19 specific risk assessments supplementary to the approved procedures for MRI, EEG, MEG and brain stimulation.
  3. Complete any training as stipulated in departmental SOPs revised for use during the COVID-19 pandemic and RTOSW risk assessments.
  4. Complete a risk assessment form for every study, detailing how COVID-19-related risks will be managed for face-to-face research. This form must be signed by the head of department and/or head of administration and finance.
  5. Where there is any doubt in relation to points 1 and 2, the relevant head of administration and finance should contact the divisional registrar.
  6. Download the supplementary information sheet for study participants, and amend to suit the research. If this will be the only change to the study, an amendment form will not be required.
  7. Consider whether any additional amendments to the study procedures and/or documentation are required. If so, update all documents using the tracked changes function of Word, and complete an amendment form detailing what has changed.
  8. Submit the following to the Medical Sciences IDREC:
  • completed signed risk assessment form
  • copy of the supplementary information sheet, adjusted for the study
  • amendment form (if applicable)
  • revised CUREC form (if applicable)
  • revised study documents (if applicable)

 

CUREC will confirm continuing ethics approval on the understanding that any required methodological or document amendments have been identified by the researcher and submitted as an amendment for approval.

Researchers then need to obtain confirmation from the facility that research activity may (re)commence. 

During the research it is advisable that both researchers and participants complete a symptom assessment form before every session. For research in the Oxford University Hospitals, please use 'COVID-19 screening form A: OUH staff member'. For all other research, download this form:

A summary of how this process should operate in departments within the Medical Sciences Division is available:

My research study has been approved by OxTREC but has either been paused or has not yet started due to COVID-19. I now wish to resume or start my study. What should I do?

In the first instance, you should contact your local unit or department for guidance and advice. If your local unit or department is satisfied that it is safe for the study to resume or start, you should then notify the OxTREC secretariat (oxtrec@admin.ox.ac.uk) of your intention to resume or start, including: 

  • setting out the current COVID-19 situation in the territory in which the study will be conducted
  • confirming that resuming or starting is in line with local government or ministry of health guidance 
  • explaining any risk mitigation steps that you will be taking (for example use of PPE, social distancing, hand hygiene, enhanced cleaning, training of staff)
  • providing confirmation that your local unit or department and the local ethics committee are satisfied that it is safe for the study to resume or start

If you have revised any of your study documents as a result of the COVID-19 situation, these should also be submitted to OxTREC (with changes showing as tracked) along with the notification of intention to resume or start the study.

Please also note that, if a bespoke territory-specific insurance policy was in place for the study, you should notify the University’s Risk and Insurance team (research.insurance@admin.ox.ac.uk) of your intention to resume or start.

I wish to submit a new study involving in-person research to OxTREC for ethical review. What should I do?

You should submit your study to OxTREC for review in exactly the same way as usual (see the OxTREC application process page for details).

However, please ensure that, as part of your application, you include details of the current COVID-19 situation in the territory in which the study will be conducted, as well as setting out any risk mitigation steps that you will be taking (for example use of PPE, social distancing, hand hygiene, enhanced cleaning, training of staff).

You should also ensure that the participant-facing documents for the study clearly address any risks arising from COVID-19 and clearly set out the measures that the research team will take to mitigate those risks.

If you have any additional questions or require any further guidance/ advice, please contact the OxTREC secretariat (oxtrec@admin.ox.ac.uk). 
 

 

A signature or email endorsement is needed from the PI, the student (if student research) and the head of department or nominee. In lieu of signatures, an email endorsement can be provided.  

  • The PI (and student, where applicable) should copy and paste the text from the ‘Declarations and signatures of researchers’ section of the CUREC 1, 2 or 3 form, or section E1 of the CUREC 1A form into an email
  • The head of department (or deputy) should copy and paste the text from the ‘Acceptance by head of department/faculty or designated nominee’ section of the CUREC 1, 2 or 3 form, or section E2 of the CUREC 1A form

For all emails, insert an electronic signature if possible, and email this from a University address to the mailbox for the relevant ethics committee. Please include the name of the PI and the title of the research project in the email header to help us identify which application the email endorsement relates to.
 

 

Researchers are welcome to contact a member of the Research Ethics and Integrity team for advice. All team members are working from home but are still available via the usual telephone numbers and email addresses.