COVID-19: CUREC guidance on research involving human participants

Research involving in-person interactions with research participants

The University has moved to Stage 0 of its Business Continuity Plan and is fully open for teaching and research. However, researchers should be mindful of the fact that some research participants may be reluctant to return to taking part in face-to-face research studies, and it may still be appropriate to offer other methods (online or remote). In-person studies involving research participants may proceed, either on University premises or elsewhere, provided that the research can be conducted in a COVID-secure way, is subject to appropriate risk assessment and all current local government and University Departmental guidance is followed.

 

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 related to the location of the research activity. The University's health guidance should also be followed. Researchers should continue to review and update their ethics applications and risk assessments so they are in line with local government and University guidance, including any Department-specific guidance.

Research staff and students should be mindful that there may be additional considerations for research involving in-person interaction with participants and consult: 

  • 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 from the Sponsorship group of the Research Governance, Ethics and Assurance team.

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    COVID-19 safe procedures for in-person human research conducted on hospital premises remain aligned with NHS procedures.  As such, separate COVID-19 risk assessments still must be submitted with applications for ethics approval that will be conducted at the following locations:

    •    NHS premises (including clinical settings within NDCN and Psychiatry)
    •    WIN/FMRIB/OHBA facilities
    •    Department of Experimental Psychology’s Old Rectory building
    •    Non-clinical settings if the research participants are vulnerable
     

    Researchers are required to complete the following before submitting their application for ethics review:

    1. 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.
    2. Complete any training as stipulated in departmental SOPs and RTOSW risk assessments.
    3. 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.
    1. Download the supplementary information sheet for study participants, and amend to suit the research.
    2. Submit the following for review:
    • completed signed risk assessment form
    • copy of the supplementary information sheet, adjusted for the study
    • CUREC form 
    • revised study documents (if applicable)

    Once ethics approval is granted, researchers need to obtain confirmation from the facility that research activity may commence. 

    During the research it is advisable that both researchers and participants either conduct a lateral flow test before attending each study session, or complete a symptom assessment form. For research in the Oxford University Hospitals, please use 'COVID-19 screening form A: OUH staff member'.

    Research on University premises

    In-person studies involving research participants may proceed on University premises, provided that the research can be conducted in a COVID-19 secure way, is subject to appropriate risk assessment and all current local government and University Departmental guidance is followed.  A separate COVID-19 risk assessment is not required, but any risks related to COVID-19 should be considered and included in the research risk assessment as appropriate.

    All members of the University are asked to take steps to reduce COVID-19 risks, and be considerate towards others.  This includes: 

    • Letting fresh air in when indoors
    • Respecting those who choose to wear a face covering and offering to wear one if not already doing so
    • Respecting other people’s space
    • Keeping up to date with COVID-19 vaccinations

    UK-based fieldwork (any research being conducted outside of University or Hospital premises)

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

    A risk assessment, including COVID-19 related risks, will need to be conducted for any in-person 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 travel and fieldwork webpage, or refer to the Safety Office's guidance or Risk assessment webpage for further guidance.

    Researchers must follow local government guidance for each Country/Territory where research will be conducted, keeping in mind that 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 revised guidance in the location of the research activity.

    In the first instance, you should contact your local unit or department for guidance and advice. If the local unit or department is satisfied that it is safe for research activity to be conducted, you should either notify the relevant CUREC subcommittee of your intention to resume research activity that had been paused, or submit a new application for review.

    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.  Note that a risk assessment will also be needed if local researchers are going to conduct research on behalf of University of Oxford researchers.

    The risk assessment must give:

    • details of current COVID-19 situation in the territory in which the study will be conducted
    • confirmation that conducting research activity is in line with local government or ministry of health guidance 
    • risk mitigation steps that you will be taking (for example use of PPE, social distancing, hand hygiene, enhanced cleaning, training of staff)
    • 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
    • progress of vaccination rollout in the location of the research

    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.

    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.

    Additional Information where a bespoke territory-specific insurance policy is required for the research (for applicants to OxTREC)

    Where you wish to resume a paused study you should notify the University’s Risk and Insurance team (research.insurance@admin.ox.ac.uk) of your intention to resume or start.

    If it becomes necessary to suspend research where additional territory-specific insurance is in place, 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.

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