COVID-19 and research

Impact of COVID-19 on research

Research projects and clinical trials conducted at WA hospitals and health services are likely to be impacted by COVID throughout 2022, particularly after the WA border opens. Some existing projects will be able to continue while others may have to be delayed or temporarily halt recruitment. At the same time, there may be opportunities for new research into COVID-19, its treatment and impact on services.

This information is provided to help EMHS researchers and clinical trial teams, together with our research partners and sponsors, to anticipate and prepare for potential disruptions - and opportunities - related to the pandemic.

Projects may be impacted by:

• Staff shortages - clinical trial teams
• Staff shortages - support departments (e.g., Pharmacy, Pathology, Imaging and Medical Records)
• Cancellation, re-organisation or re-prioritisation of clinical services affecting project feasibility
• Possible hospital access restrictions for external researchers and clinical trial monitors
• Supply chain issues affecting supply of trial materials

These factors may lead to:

• Project feasibility and start up being delayed or put on hold
• Slower recruitment for existing projects and trials
• Temporary suspension of recruitment

Researchers and clinical trials teams are encouraged to plan for potential disruptions to existing and new projects early and to keep an eye on original source links below for updated WA government and WA Health advice.

National and WA Health advice on research and the pandemic

The NHMRC maintains a COVID-19 webpage that provides general advice to institutions, Human Research Ethics Committees (HRECs), researchers and sponsors about managing their work and functions during the pandemic. The advice is particularly relevant to those conducting sponsored clinical trials and other clinical research.

The WA Department of Health COVID-19 information for health professionals includes information on clinical guidelines, PPE use within WA Health, infection prevention in hospitals and testing advice and criteria.

Urgent Project Amendments

EMHS supports the NHMRC’s guidance for prioritising and expediting approval and variations for COVID-19 research and other clinical trials (See: https://www.nhmrc.gov.au/research-policy/COVID-19-impacts).

COVID-related amendments should be submitted as soon as possible. This particularly relates to amendments to study visits (e.g., shifting to phone or web-based follow-up visits) or other changes that are required to ensure continuity of clinical trial visits or trial treatments.

If an urgent amendment is needed for a project, please contact the Research Hub (see Contact Us).

While amendments will still need to be submitted via the RGS and reviewed in the standard way, we will triage those that are COVID-related and expediate their review.

New research projects

We understand that EMHS staff might develop new COVID-related research projects or join multi-site projects and these will likely require expedited review to meet recruitment targets and align with the pandemic’s timeline.

Staff planning to submit for approval a new COVID-related project should contact the EMHS Research Manager at the earliest opportunity (See Contact Us)

Hospital Access

Patients

Patients are permitted on public healthcare sites regardless of vaccination status.

While under new State Government rules that take effect from January 31 (see link below), visitors over the age of 16 years will be required to provide proof of double vaccination to enter any EMHS hospital a visitor, this requirement will not apply to patients or their carers or guardians, though they will be required to wear a mask at all times on hospital premises.

Researcher Access

External research personnel, such as from Universities or clinical trial sponsors/contract research organisations, should liaise with their EMHS researcher and trial team contacts when planning to access EMHS sites for research activities.

Requirements to access WA hospitals, including proof of vaccination requirements, from 31 January 2022 are available at the following site: https://www.wa.gov.au/government/announcements/proof-of-covid-19-vaccination-expand-state-wide-monday-31-january

WA restrictions may change so it is essential to check the updated requirements here:

EMHS may also need to limit access for some non-essential purposes throughout 2022. It is essential that all external researchers and sponsor representatives confirm requirements with their EMHS research contacts prior to planning site visits.

Clinical Trial Site Visits

Remote monitoring is strongly encouraged. Please see EMHS Remote Monitoring for Clinical Trials for information about how remote monitoring should be conducted at EMHS sites.

After the WA border re-opens, on-site initiation and monitoring visits may be possible. However, noting the general access advice above, sponsor representatives should liaise with EMHS clinical trial teams to discuss the best approach to conducting site initiation and monitoring visits before arranging on-site visits, especially by interstate-based representatives.

On-site visits must be:

• Supported by the EMHS trial team
• Planned with contingencies in the event of sudden additional access or border restrictions and site capacity limitations that may lead to cancellation of the visit.

General information about how WA is managing COVID and the WA border controls is available at: https://www.wa.gov.au/government/covid-19-coronavirus