Facilitating world-class research
University research support is largely still functioning in the online environment. Please do email your departmental research facilitator/support officer and/or Research Services grants contact to discuss your idea and plan for submission at the earliest opportunity, so we can plan your preparation and submission and alert the appropriate approvers.
Research Services remains operational, however please allow extra time ahead of the funder submission deadline, and ensure your head of department and/or head of administration and finance are available to approve. Most funders have an online submission portal, and departmental/faculty approval of budgets through X5 is also performed online. If your departmental approvers are not available, please contact your research facilitator/support officer, or your Research Services grants contact as soon as possible so we can assist.
Please contact your research facilitator/support officer and Research Services grants contact as soon as possible so that we can fast track your application through approval and submission processes.
Most funders are taking a pragmatic approach to dealing with the evolving situation, and we are aware that some deadlines have been extended. However, this is likely to be funder and/or scheme specific so please check the funder website for further information. We will also be keeping our information on this page as up to date as possible.
Arrangements are in place to try to ensure contracts are signed in a timely manner. However, we strongly urge you to contact your departmental administration team and Research Services contracts contact at the earliest opportunity if the contract is particularly urgent or is connected with a specific deadline.
We are aware some funders are delaying or postponing review panel decisions as a result of impact. Funders will notify applicants about the outcome of applications in due course.
Most funders are taking a pragmatic approach to dealing with the evolving situation. This is likely to be funder and/or scheme specific so please check the funder website for further information. We will also be keeping our information on this page as up to date as possible.
Online systems continue to be supported with staff working remotely.
Contact the X5 helpdesk as usual.
We are currently unable to deliver X5 training but are working on online alternatives for new users.
Please contact Julia Haynes or Sue Douglas as usual, by email rather than phone if possible.
Support arrangements are unchanged. Details can be found on the IRAMS page.
Research Services remains operational. Please liaise with your usual Research Services grants contact. If your acceptance requires a ‘wet’ signature we do have procedures in place to make this possible, and will work with you and the funder to ensure this is complete.
Where allowable within the funder’s terms and conditions (and with the exception of essential research relating to COVID-19) we would advise considering delaying the start of your project to ensure there is minimal impact on your research through any delays caused by COVID-19. Please contact your Research Services grants contact for advice where the funder is not clear.
Yes, however, please consider delaying the start if possible (see question above on delaying the start of new projects).
We are receiving confirmation from some funders that they fully support this direction and will provide no-cost and/or cost extensions to projects where staff have returned to clinical duties to support the coronavirus pandemic. There may be an expectation from some funders that the NHS will ultimately reimburse the project for associated salary costs incurred.
Presuming this is in line with the contract (for example the work has been completed, or advance payments were agreed), please ensure your subcontractor sends the invoice electronically to the email address in the agreement with all the relevant backing documentation and this will be paid.
No paper invoices, PRFs, expense claims, or advance requests should be sent to Research Accounts at Hythe Bridge Street. All documents should be handled electronically.
Please consult with your departmental administration. Payments are being prioritised by the University. Given the capacity of the payments process, please consider whether a subcontractor payment is urgent.
The Foreign and Commonwealth Office have a current notification (posted 17 March 2020) to avoid all non-essential travel, worldwide. We will be in contact with funders on alternative arrangements and possible no-cost extensions to grants where international travel is required, but cannot take place until a safer period.
The Association of British Insurers (ABI) has published information on the travel insurance implications of coronavirus.
Research staff and students are now required to pause or postpone ongoing or planned non-essential University research involving face-to-face interactions with human participants (unless arrangements can be made for the research to be conducted remotely or online).
Students will not be able to undertake fieldwork involving face-to-face interaction with participants that may have been planned for Trinity term. The same may apply to some other types of project, such as those that require access to materials that are only available in hard-copy archives. We recognise that some students may already have started a project that cannot now be completed, and that the scope will need to be dramatically altered.
Students affected by this change should consult the course director in their department or faculty to postpone or agree an alternative project that can be completed from their desk (such as literature reviews, data analysis, conducting interviews by telephone or via teleconferencing, using online surveys or computer modelling).
If students have any questions about the above, please contact your college or department/faculty in the first instance.
If you are considering overseas travel, note that the FCO’s advice is against all but ‘essential’ travel. It is unlikely that research, teaching and other University business will be considered essential, although there may be exceptions such as travel connected with tackling the coronavirus outbreak.
For further advice about overseas travel and fieldwork (including advice about how the University’s insurance will operate), please see the University Safety Office’s COVID-19 guidance.
If you live in the UK and are currently travelling abroad, you are strongly advised to return now, where and while there are still commercial routes available.
The Foreign and Commonwealth Office guidance covers issues including visa arrangements, travel back to the UK, quarantine while you are abroad, and advice to follow if you cannot return to the UK.
For further advice about overseas travel and fieldwork (including advice about how the University’s insurance will operate), please see the University Safety Office’s COVID-19 guidance.
Please consult the University’s guidance on coronavirus for latest information on access to University buildings and facilities.
Funders are releasing guidance and many are confirming that no-cost extensions in such circumstances will be allowed. Overall we expect funders will be pragmatic when considering requests to extend projects, although some may wish consider such requests on a case-by-case basis. Please see the Guidance from research funders page.
This will vary dependent on the funder and the nature of cost. The University is actively engaging with our major funders and UK government to seek clarity and appropriate measures on this. Some funders (including the Wellcome Trust) have indicated some intention to provide additional funding, however the mechanisms and details for this have not yet been finalised.
We anticipate that funders will adopt a pragmatic approach on this, however it is likely to be variable, so please refer to the individual funder’s guidance.
Where travel plans have been cancelled upon government advice, the costs should be recovered from the travel supplier where possible. If you booked travel via Key Travel please contact them directly.
The Insurance team are experiencing an extremely high volume of queries at the moment and are therefore unable to comment on specific and/or hypothetical insurance related queries regarding cover.
Our advice remains the same for travellers who have taken out the University Travel Insurance. Please ensure that all FCO advice is followed and additionally any advice given by the insurance assistance provider – AON Protect Assistance. Disregarding advice will likely mean cover will not remain in place. Please follow advice and take reasonable and pragmatic decisions. Any subsequent claims will be looked at in the coming months.
Please note that AON Protect do not advise on insurance coverage and policy terms but will advise on travellers' individual circumstances and can assess on whether it is sensible to return and if this is in their best interest.
Please consult with your departmental administration team. Further University guidance around recruitment during the current period of disruption is expected.
Specific guidance on the Coronavirus Job Retention Scheme (CJRS) for research and research support staff can be found on the HR Support website. Guidance issued by funders on CJRS/furlough can be found under the Guidance from research funders page. The University is engaged urgently with funders and government around the issues of fixed term staff on externally funded projects.
Please refer to the University's guidance on coronavirus and to the further guidance for event managers.
If your research requires (or has already received) ethical review and approval by the Central University Research Ethics Committee (via one of its subcommittees), please see the guidance on research involving human participants
Support arrangements are unchanged, as detailed on our MARS webpage.
Support arrangements are unchanged. Please email email@example.com for user access set-up/changes/removal and email firstname.lastname@example.org for BI queries in the first instance.
Support is by email to the Oxford Researchfish Support Team at email@example.com
Support is by email to firstname.lastname@example.org.
Queries will be resolved on the same day if possible. More technical queries may take a little longer to resolve due to staff availability.
The COVID-19 pandemic demands an urgent and unprecedented response.
University research and expertise is critical to this effort, and Oxford University Innovation (OUI) is supporting a growing number of projects from Oxford University involving intellectual property and technology that could help address the
current pandemic. These include vaccines, rapid diagnostics, ventilators, therapeutics and remote monitoring technology.
OUI has issued guidance for organisations seeking to license or otherwise access University of Oxford IP relevant to the COVID-19 pandemic:
Last updated on 14 October 2020: additional guidance on seeking early advice from the MHRA and how HRA decides which studies will be fast tracked. Further clarification that while a study or trial was on pause this does not extend the study or trial automatically.
As early as possible. If your research will involve OUH patients, staff and/or resources, you should contact email@example.com.
The OUH/OU COVID-19 Clinical Research Review Group chaired by the deputy head of the Medical Sciences Division for research and translation and with representation from the Joint Research Office and the major areas of activity (acute medicine/ITU, respiratory, immunology/inflammation), will triage all proposals for clinical research studies and trials at a very early stage in order to ensure that those that are prioritised can be given the fullest and quickest support by the respective Joint Research Office teams.
A template form will be provided and this form must be submitted for review prior to any funding applications being submitted. For further details please contact firstname.lastname@example.org.
The MHRA encourages early discussions about new clinical trials, and are now offering informal one-hour regulatory advice meetings. To arrange a meeting, you should email a list of questions and an outline of your proposal to CTU.email@example.com.
For COVID-19 related clinical trials, the MHRA now also provide an optional pre-assessment service, which can take place prior to the formal submission. To access this support, email firstname.lastname@example.org, including any documents that you would like them to review.
Yes. On CTRG advice, obtain an IRAS number. We will review new COVID-19 studies swiftly and will negotiate expedited review of the study by the appropriate regulatory bodies, who now have systems in place for this.
The MHRA is currently approving initial applications of COVID-19 trials with an average time of 9 days.
The HRA has published on their website how they decide which studies will be fast tracked. The HRA expect this request to come via CTRG.
If you need to make an urgent change to protect participants against any immediate hazard to their health or safety, these should be handled as an urgent safety measure (USM). Make the change, and then notify the REC & MHRA (if applicable) as soon as you can. The REC requires notification by telephone, and then in writing within 3 days. Notification by email is sufficient for the MHRA – a phone call is not necessary. CTRG should also be informed within 3 days of implementation of the measure.
A substantial amendment should subsequently be submitted to cover the changes made. Submission to the MHRA can be deferred for 28 days after the measure has been taken and written notification provided by email. Further extensions may be granted on a case by case basis.
This should be treated as an urgent safety measure, following the guidance in question 3. Consider using separate specific information sheets detailing the additional tests, rather than amending the existing participant information sheet.
This requires a substantial amendment which will receive expedited review by CTRG and relevant regulators.
When you submit to CTRG, please note in the subject header that the amendment is COVID-19 related. If the study will involve OUH, CTRG will advise whether the OUH/OU COVID-19 Clinical Research Review Group will need to review the amendment (see question 1). If the study is currently on hold at OUH, confirmation by the group will serve as an exemption, and the study will be able to restart when the amendment has relevant approvals.
Replacing face-to-face study visits with phone calls is acceptable where appropriate. Documentation of the phone call should be kept, as this will constitute source data. This is allowed on a temporary basis, for as long as the outbreak prevents face-to-face visits.
Participants should not be included in a trial unless you can confirm they meet the inclusion and exclusion criteria. Similarly, if the safety of a participant is at risk because they cannot complete key safety checks, you must consider whether to withdraw that participant. Where necessary, urgent safety measures may be implemented first followed by a subsequent substantial amendment, as outlined in question 3. You should also consider whether it is appropriate to temporarily halt recruitment (see question 15), or the study as a whole (see questions 16, 17, 18).
Handling changes to participant visit methods/frequency should be handled as follows.
Submit a non-substantial amendment to CTRG for authorisation. CTRG will process it as a Category C minor amendment not requiring HRA/HCRW approval (if relevant) and once authorised you can implement this and send it out immediately to all your sites.
This requires a substantial amendment, which will receive expedited review by CTRG and relevant regulators. When you submit to CTRG, please note in the subject header that the amendment is COVID-19 related.
Changes to visit methods and/or frequency should be risk assessed, notified to CTRG, and documented in the Trial Master File along with a record of any protocol deviations. In the current circumstances, a formal amendment is not required for CTIMPs to implement these changes, and they will not be considered a serious breach of the protocol.
This should be risk assessed and documented in the Study/Trial Master File, and a non-substantial amendment submitted to CTRG for authorisation.
CTRG will process it as a Category C minor amendment not requiring HRA/HCRW approval (if relevant), and once authorised you can implement this and send it out immediately to all your sites.
Verbal agreement that participants are happy with the arrangements should be documented in their notes.
A risk assessment should be undertaken to determine the impact of this, and CTRG should be contacted to further discuss the following possibilities (please note in the subject header that your email is COVID-19 related):
Please ensure that all assessments, correspondence, decisions and actions are documented in the Study/Trial Master File.
The changes should be risk assessed, and the impact on the study documented in the Study/Trial Master File. If it is appropriate to resort to remote monitoring, use alternative means of oversight such as teleconference or videoconferences where possible.
If confidential information will be handled in a manner that is not outlined in the participant information sheet, this will require a substantial amendment which will receive expedited review by CTRG and relevant regulators. When you submit to CTRG, please note in the subject header that the amendment is COVID-19 related.
Otherwise, submit a non-substantial amendment to CTRG for authorisation. CTRG will process it as a Category C minor amendment not requiring HRA/HCRW approval (if relevant), and once authorised you can implement this and send it out immediately to all your sites.
If it is proposed to access electronic health records (EHR) away from sites, please contact CTRG to further discuss. Your department may have developed policies and/or standard operating procedures to manage this.
If this is the case, you may consider the following:
If expectedness has been delegated to investigators at clinical sites and this places a burden on front line staff, determine whether this assessment can be made by the coordinating centre upon receipt of the SAE. This may be appropriate because expectedness is not a medical decision, rather it should be based on the approved reference safety information for the trial.
The MHRA expects regulatory timelines for safety reporting to continue to be met. However, to reduce administrative burden on sites, it is acceptable in the current situation for SAEs to be reported to the coordinating centre by phone or email, followed by a written report at a later date. Initial contact should include the minimum reportable information. The coordinating site should consider a process to record this initial information, and ensure that this process protects data integrity.
The above changes do not require prior authorisation by the MHRA, but they should be risk assessed and documented, and CTRG should be informed.
Other proposed changes to safety reporting procedures should first be discussed with CTRG for further advice, with an outline of the impact on the risk-benefit of the trial and strategies to mitigate any risks introduced by the changes.
Please include ‘COVID-19 safety recording/reporting’ in the subject header of emails relating to any of the above.
Consider alternative methods to demonstrate approval, for example email confirmation. You should document any deviations from your normal processes, but you do not need to submit an amendment to inform CTRG of such a change.
The MHRA have confirmed that electronic signatures are acceptable for requests for a clinical trial authorisation, and these can be scanned electronic signatures if necessary. Alternatively, if the person authorised to sign has an individual CESP user ID, this can be used in the ‘signature’ field of the application form.
Protocol waivers are not acceptable.
Ensure that any deviations from formal processes are recorded. An increase in deviations related to COVID-19 will not be considered a serious breach (unless participant safety is affected).
The MHRA acknowledge that reporting timelines for SAEs, DSURs and End of Trial notifications may be delayed due to capacity issues. Such temporary deviations from the reporting timelines stated in the protocol do not have to be notified as a substantial amendment. If your DSUR is delayed, please provide a rationale in the cover letter. Normal processes should resume as soon as possible once the capacity issues have been resolved.
You don’t need to seek any approvals for this, but you need to place a file-note in the Study/Trial Master File recording the temporary halt. Once the current emergency is over, you can restart recruitment.
Please notify CTRG of any halts to recruitment and also when recruitment is restarted. If you need to make changes to protect participant safety when restarting, this will need to be handled as a substantial amendment.
If you also need to make changes to procedures for existing participants, please refer to question 7.
Submit a non-substantial amendment to CTRG for authorisation. CTRG will process it as a Category C minor amendment not requiring HRA/HCRW approval (if relevant), and once authorised you can implement this and send it out immediately to all your sites.
If the halt will have a direct effect on participant safety, this will require a substantial amendment which will receive expedited review by CTRG and relevant regulators. When you submit to CTRG, please note in the subject header that the amendment is COVID-19 related.
This only requires a substantial amendment if it will have a direct effect on participant safety. In this case, it will receive expedited review by CTRG and relevant regulators. When you submit to CTRG, please note in subject header that the amendment is COVID-19 related.
Otherwise, you just need to place a file-note in the Trial Master File recording the temporary halt, and notify CTRG of the halt and also when the trial restarts. If you need to make changes to protect participant safety when restarting, this will need to be handled as a substantial amendment.
If you decide not to recommence a halted trial, you will need to submit an End of Trial declaration to the MHRA and CTRG within 15 days of the decision.
You should contact the MHRA directly, by phone or email, as they can escalate this to the DHSC. Please also notify CTRG if this situation arises. Submission of an amendment is not required in this instance
You should submit an End of Study declaration to the REC, MHRA (if appropriate) and to CTRG. You need to follow this up with your final report within one year.
This will require a substantial amendment if the post-study care will be different to that set out in the participant information sheet and thus will differ from what participants have consented to. You will need to discuss with CTRG whether expedited review of this amendment will be required.
Considerations for restarting studies that have been paused due to COVID-19 are outlined in the NIHR ‘Framework for restart’.
Although this framework has been written specifically for NIHR research activity, the principles are applicable for all clinical research and should be consulted when you are preparing to restart.
Participant safety remains paramount, and any risks to participants should be assessed. If you need to make changes to protect participant safety when restarting, this will need to be handled as a substantial amendment.
You should also consider evaluating and confirming the ability of each site to recommence, as well as whether any staff retraining or revalidations are needed.
Remember to document all assessments, communications, actions and regulatory approvals.
It is important to ensure that any plans to restart or resume studies that involve University staff or facilities are consistent with the University’s current position, in addition to any host organisation requirements.
Divisions and departments are currently reviewing all the measures that need to be in place for research to restart or resume within University buildings. Work on studies needs to be considered within the portfolio of risk under review by a department.
In order for a study to restart or resume activities, at the request of the Medical Sciences Division, CTRG requires confirmation from the departmental head of administration and finance (HAF) that full consideration has been given to safety, estates, HR and IT support. This includes confirmation that activities related to this study are not considered to be in conflict with any of the department’s research priorities and are consistent with the current return to onsite working status, including that the building is open, and the risk assessment has included sign-off from the head of department.
CTRG does not require an additional risk assessment document, as this is dealt with at departmental level.
Please contact CTRG by emailing email@example.com for a HAF confirmation email template.
The same applies for new studies.
If the pause was communicated to CTRG as a non-substantial amendment, submit a non-substantial amendment to CTRG for authorisation. CTRG will process it as a Category C minor amendment not requiring HRA or HCRW approval (if relevant) and once it is authorised you can implement it and send it out immediately to all your sites.
If restarting requires substantial changes, for example to protect participant safety or data integrity, then you will need to submit a substantial amendment in order for it to restart.
If the study returns to pre-COVID-19 arrangements that were previously approved, this does not need to be approved when reinstated. If some arrangements revert to previously approved arrangements and other elements remain for an interim or long-term period, this also does not require HRA or HCRW approval but this should be risk-assessed.
A pause to the study does not extend the study duration automatically. If the study is approaching its end date, submit a non-substantial amendment to CTRG for authorisation (for insurance purposes CTRG do need to know if the study is ongoing).
Any assessments and decisions should be documented in the Study Master File.
If a substantial amendment has been approved to halt the trial, then you will need to submit another substantial amendment in order for it to restart.
If the trial was halted without the need for a substantial amendment, but restarting requires substantial changes, for example to protect participant safety or data integrity, then you will need to submit a substantial amendment in order for it to restart.
If the restart of the trial does not involve any substantial changes to the clinical trial authorisation, a substantial amendment is not required. CTRG still needs to confirm support for the trial activity to restart.
A pause to the trial does not extend trial duration automatically. If the trial is approaching its end date submit a non-substantial amendment to CTRG for authorisation (for insurance purposes CTRG do need to know if the study is ongoing).
If you decide not to recommence a halted trial, you will need to submit an end of trial declaration to the MHRA and CTRG within 15 days of the decision.
During the current situation, the MHRA is allowing some flexibility for use of CE-marked devices for a different purpose where there is limited change to its intended use, without the requirement of a prior clinical investigation.
If you feel the change is minor (for example, using the device in a different setting) you should perform a risk assessment and contact your notified body for advice. If the outcome is that a clinical investigation is required, please contact CTRG to discuss further, noting in the subject header that the investigation is COVID-19 related.
Yes, in this exceptional situation the MHRA may authorise the supply a non-CE marked device in the interest of the protection of health.
You will need to apply to the MHRA by emailing firstname.lastname@example.org, providing the information outlined in the government guidance. The MHRA will advise on exemption from the Devices regulations. They will prioritise applications based on the needs of healthcare providers to increase the supply of critical devices and tests.
CTRG does not need to be informed of your application to the MHRA for exemption, unless the outcome is that the Devices regulations will apply. In this case, please contact CTRG to further discuss.
Amendments need to be authorised by CTRG and the relevant regulators as normal, but those that are due to the impact of COVID-19 will receive expedited review. When you submit to CTRG, please note in the subject header if the amendment is COVID-19 related.
Note that the MHRA requires information on any changes made to:
• the device under investigation
• study documentation, including the clinical investigation plan
• investigators or investigating institutions
• changes requested by an ethics committee
You need to notify the MHRA, by emailing email@example.com, and CTRG, as soon as possible.
Before you restart, both bodies will need to be provided with a summary of the actions taken and whether there was any impact on participant safety. It is important that you keep a record of all your actions and correspondence.
You should ensure that any deviations from formal processes are recorded. CTRG and the MHRA do not need to be notified of deviations related to COVID-19, unless participant safety is affected.
Contact the MHRA as soon as possible at firstname.lastname@example.org. They will review and advise on a case-by-case basis. It would be helpful to note in the subject header that the investigation is COVID-19 related. Please include CTRG in your correspondence with the MHRA.
Carefully document all actions and risk assessments you take in response to COVID-19 to determine the impact. Your main focus should be on the safety of participants in your clinical investigation. Please contact CTRG and/or the MHRA if you need further advice.
Contact the Human Tissue Governance Team at email@example.com and put 'COVID' in the subject heading.
If you plan to import material from Scotland or abroad, download the International Collaboration Checklist from the Oxford Global Research website and see section 'I'.
General FAQs about Human Tissue Authority licensing can be found on the Human tissue governance FAQs page.
The REF funding bodies have confirmed a revised submission deadline of noon on 31 March 2021.
The exercise is scheduled to resume on 31 July 2020. As previously advised the staff census date of 31 July 2020 remains unchanged.
In recognition of ongoing uncertainty about the effects of COVID-19, the funding bodies have set a review date in November 2020.
They have also confirmed an extension to the assessment period for impact to 31 December 2020.
REF project managers are all currently able to work from home, so will be able to support you as usual (albeit remotely).
If you are not sure who your usual divisional contact is, or if you need support from Research Services, please email firstname.lastname@example.org.
Yes, you can still seek feedback on a decision or appeal a decision in the way outlined on our REF webpages.
If you are unable to deposit a research output because of major disruption to your usual work due to illness, caring responsibilities, or clinical duties, we should be able to apply one of the exceptions to the Open Access policy.
Please deposit into Symplectic Elements when you can and the Open Access team will work on the output as usual.