Update for studies

NHS Projects

Fast track review for COVID-19 studies:

The HRA will fast track REC review of COVID 19 studies, and for more information visit the HRA COVID-19 webpages

The RGIT will also fast track sponsorship review of these projects, but please ensure that you contact the RGIT before any fast track review is booked via the HRA. Please ensure that sites are able to support the study and that you leave enough time for the RGIT to review any project prior to booking your REC meeting. RGIT review and sign off must be in place for all research projects prior to submission to REC. 

The situation with COVID-19 is rapidly changing.

Some NHS trial sites are introducing their own measures and advice about potential halting of patient recruitment into clinical trials. You should take note if you receive such advice and if you have any questions or concerns relating to ethics or regulatory oversight, please raise them with Ruth Nicholson or Lynne Cox.

 

For interventional trials:

 In the event that a trial cannot continue then the usual process should be followed regarding:

  • protocol deviations and safety oversight.
  • Missed trial visits due to a lock down situation or a participant being unable to attend the site would be protocol deviations.
  • If the trial cannot continue to run safely, for example due to lack of trial staff, or restrictions on visits/travel and ability to perform safety assessments then it is expected that appropriate action would be taken which could include Urgent Safety Measures.
  • Safety of trial subjects should always remain the priority, and if halting the trial is the only way to ensure this, then this would be expected.

We would therefore ask that you monitor the situation. Mitigation measures should be considered in advance where possible, for example if any amendments would be required, reduced research team numbers, including delegation log review and also delegation of who to contact if the PI is unavailable. Monitors having access to sites will also need to be considered if relevant, or remote monitoring. Risk assessment should be considered in all cases.

Temporary halts to studies will still require reporting as per regulatory guidelines. It should be considered if funders will also need to be informed.

In any case where an Urgent Safety Measure is required it should be ensured that all reporting requirements to ethics and regulatory authorities are met throughout the trial. If a local site PI puts in place a USM then this needs to be communicated to the study team and Sponsor immediately.

Visit the MHRA guidance page for more information on USMs,  the trials unit helpline should be called within 24 hours of measures being taken, and no more than 3 days from the date that measures are taken.

It is likely that study sites will request information from study teams, or they could potentially suspend recruitment or implement other safety measures. It is therefore advisable that a risk assessment of the study is considered, and in-particular if the target population of the study present with flu like symptoms. Studies that involve hospital areas that could come under additional pressure should also consider if this will cause issues with recruitment or the ongoing running or safety of the study.

 

For studies that would normally require CAG approval that are using COVID data will need to go via the fast track ethics process, email the COVID-19 data sharing team instead of applying to CAG. This will not remove the need for a Data Protection Impact Assessment (DPIA) at the College. This is covered until 20 Sep 2020 currently, under a notice from the Secretary of State of Health and Social care. Therefore if you get a study like this then please ensure you have checked any dates for how long data collection will take place.

 

Reminder- Any temporary suspensions, recruitment halts or other interruptions to clinical trials and studies need to be reported to the Sponsor. For Imperial College London and Imperial College Healthcare NHS studies, please contact Ruth Nicholson.

 

Re-starting studies:

Re-opening studies or sites that have been paused

Where individual sites are able to re-open after being paused, arrangements should be risk assessed and agreed with the site. For CTIMP studies this risk assessment should be agreed with the RGIT CTIMP team. 

If recruitment has been paused the a file note in the site file/TMF should be put in place regarding the study opening. The RGIT should give the ago ahead for this as sponsor in all cases. 

Where a study as a whole wishes to re-open, it is expected that this will have been discussed and capacity confirmed with sites before re-opening. Where the pause was communicated to sites in a non-substantial amendment, any re-opening can also be communicated to sites in a non-substantial amendment. This does not require HRA/HCRW Approval but does require sign off via the RGIT. 

Reverting arrangements put in place during COVID-19

Any return to arrangements previously approved prior to COVID-19 needs to be approved by the RGIT, but will not need approval from HRA/REC.

Similarly, if some arrangements revert back to previously approved arrangements and other elements remain for an interim or long-term period, for example retaining the option for phone calls or postal questionnaires, these do not need HRA Approval but will need notification and approval from the RGIT. 

Clear communication to sites should be provided and clarity given about the versions of documents that should be followed. A list of current documents with version and dates should be submitted to the RGIT along with all changed documents. If a protocol addendum or other have been used then it should be clarified when no longer in use.

New amendments to the study required for the study to re-open will need to be reviewed and should follow standard HRA guidance on COVID amendments. 

 

For Masters and Undergraduate projects:

The HRA have decided stop reviewing applications for individual undergraduate and master’s student projects from now until further notice.

Please see this new guidance which relates to health and social care research projects conducted by undergraduate and master’s students: 

 

For further advice please see the following guidance from the HRA and MHRA:

ICREC-SETREC studies

In light of the situation current situation and the potential impact of Coronavirus on research studies, the research office would like to issue the following guidance. Some sites, ethics committees and regulatory authorities abroad may be issuing their own guidance and measures. Please take note of such advice and if you have any questions or concerns ethics or regulatory oversight, please raise them with Ruth Nicholson  or Lynne Cox.

For studies running in the UK that involve healthy volunteers or College staff and students, please be aware of any continuing government or College guidance which may affect study recruitment or study procedures. Studies abroad should consider the current situation in each country where the study is running. 

If you are running a clinical trial abroad then please take be aware of the following guidance:

  • In the event that a trial cannot continue then the usual process should be followed regarding protocol deviations and safety oversight.
  • Missed trial visits due to a lock down situation or a participant being unable to attend the site would be protocol deviations.
  • If the trial cannot continue to run safely, for example due to lack of trial staff, or restrictions on visits/travel and ability to perform safety assessments then it is expected that appropriate action would be taken which could include Urgent Safety Measures.
  • Safety of trial subjects should always remain the priority, and if halting the trial is the only way to ensure this, then this would be expected.

The above should take into account regulatory requirements of the country where the study is running.

We would therefore ask that you monitor the situation. Mitigation measures should be considered in advance where possible, for example if any amendments would be required, reduced research team numbers, including delegation log review and also delegation of who to contact if the PI is unavailable. Monitors having access to sites will also need to be considered if relevant, or remote monitoring. Risk assessment should be considered in all cases.

Temporary halts to studies will still require reporting as per regulatory guidelines. It should be considered if funders will also need to be informed.