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CSO guidance on clinical research in response to additional lockdown measures

CSO guidance on clinical research in response to additional lockdown measures

12th January 2021

Research, development and innovation are crucial in the response to the COVID-19 pandemic and are a core component of NHS Scotland’s role as a person-centred, evidence-based healthcare system.

On January 4th, additional lockdown measures were put in place by the Scottish Government to safeguard health, save lives and protect the NHS in the context of a steep rise in Coronavirus (COVID-19) infections.

The Chief Scientist Office recognises that many NHS Scotland sites are facing greatly increased pressure due to the rise in COVID-19 hospital admissions. It is critical under these very challenging circumstances that NHS Scotland continues to recruit patients into Urgent Public Health (UPH) studies. This research activity is essential to develop approaches that will reduce transmission, reduce the number of patients that require hospitalisation and guide the treatment and care of patients, now and in the future. CSO can therefore confirm that the current levels of prioritisation for research studies still apply, namely:

  • Level 1a (Top Priority) - COVID-19 UPH vaccine and prophylactic studies (as prioritised by the Vaccines Task Force) and platform therapeutics trials (currently RECOVERY/RECOVERY+; PRINCIPLE; REMAP CAP; SIREN; ISARIC)
  • Level 1b - Other COVID-19 UPH studies
  • Level 2 - Studies where the research protocol includes an urgent treatment or intervention without which patients could come to harm. These might be studies that provide access to potentially life-preserving or life-extending treatment not otherwise available to the patient
  • Level 3 - All other studies (including COVID-19 studies not in Level 1a or 1b)

We are also writing to confirm that:

  • the deployment of staff funded through NHS Research Scotland to front line duties should only occur in exceptional circumstances so that UPH-badged studies (including vaccines studies) and wider non-COVID-19 portfolio research activity can be maintained
  • the deployment of Clinical Academic staff (both medical and non-medical) should be undertaken within the guidelines issued by the UK Clinical Academic Training Forum working group and the Conference of Postgraduate Medical Deans of the UK

An integral part of Clinical Research is the work carried out in University facilities. Scottish Government guidance remains that only essential work should take place in Laboratories and Research Facilities, subject to robust and ongoing risk assessments with full input from trade union or workforce representatives.

Critical and essential work is defined as an activity that

  • cannot be delayed until the protection level for the area has been lowered;
  • cannot be carried out at home or outdoors;
  • is safe for the people involved (based on risk assessment);

and any activity, in any discipline, that is directly or indirectly related to any of the following:

  • medicine
  • human health and wellbeing
  • public health
  • health and safety
  • healthcare, social care or self-care
  • any activity needed to enable or support any of the above

A comprehensive list of essential research is available at Coronavirus (COVID-19): guidance for laboratories and research facilities.

The approach to restarting and building resilience into the NHS Research Scotland portfolio in the face of the COVID-19 pandemic is guided by the Restart Framework developed by the National Institute for Health Research (NIHR) in consultation with the Devolved Administrations.

As indicated by the Restart Framework, currently we need to continue to prioritise our support for the most urgent COVID-19 research as part of the response to tackle the pandemic. At the same time, we need to ensure we continue to try and maintain support to deliver non-COVID studies currently open on the NHS Research Scotland portfolio, particularly those within Level 2.

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