COVID-19 and research processes

*Please note that this information may be updated depending on the latest information and advice from the health service and/or Government.

COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors

Information is now available on NHMRC’s website and published in the Downloads section. It is also available on the Department of Health Website.

It provides general information and advice to institutions conducting or overseeing research, Human Research Ethics Committees (HRECs), researchers and sponsors in the context of the COVID-19 pandemic. It is directed towards those involved in clinical trial research and other relevant clinical research, but also may be of use to institutions, HRECs and researchers in other fields.

The advice represents current thinking and best practice at the government level and will be reviewed and updated regularly to reflect changes in government policy, public health advice and the needs of those conducting and participating in clinical research in Australia.

This advice is supported by CAHS.

Impact of COVID-19 on research

In accordance with COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors,COVID-19 represents an unprecedented challenge to the health and research sectors. Our response to this challenge should be in line with several key principles and considerations.
These are:
• The safety and well-being of patients, research participants and their families, and health care professionals, researchers and other staff involved in patient care and research are
paramount.
• It is critical that public health systems remain able to respond to the needs of the community, both those impacted by COVID-19 and in terms of regular workloads.
• The conduct of research related to COVID-19 is a significant priority; however, the initiation and continuation of other ongoing and proposed research may also be critical
for the well-being of patients, participants, communities and the research sector.
• Compliance with or adherence to regulations, guidelines, codes, policies and other standards remains necessary. However, interpretation of research responsibilities in the
context of a crisis such as COVID-19 should be informed by flexibility, consultation and good sense so as to retain the focus on the safety and well-being of those most at risk in
our institutions and communities.  

COVID-19 and research processes at CAHS

This web page has been set up with information specific to CAHS researchers and our research partners. All research activity should adhere to existing policies and guidelines set by the health service and State and Federal Governments for research, remote working arrangements and other COVID-19 response and management.

Refer to the The WA Health Covid-19 Framework for System Alert and Response(SAR).

For more specific information on COVID-19 research processes at CAHS, please refer to this document. 

In the first instance, please refer to the CPI/PI for specific advice related to the individual project. The CAHS Department of Research can provide additional support or advice if clarification or extra detail is required.

 

Flowchart: Research activity

 

What does this mean for your research project? 

Find out more under the various options below. New content will be added regularly.

 

There are many changes happening within the healthcare system that may impact a team’s ability to continue their research. This includes, but is not limited to, restrictions on elective surgery, availability of research outpatient facilities and an increased demand on clinical service delivery.

Researchers can adhere to GCP requirements (4.5.4) and the National Statement (5.5.6) in relation to their approved research projects and implement any required deviation or amendment to the approved protocol to manage an immediate safety risk to participants or staff. A qualified physician in consultation with the sponsor should make this decision in regards to the safety of participants (GCP 4.3.1). 

Due to the workload of the SASC and the current priority to review urgent research issues out of session there will be limited capacity to review new applications, unrelated to COVID 19, in the short term. Please check the website for any updates as they become available.

CAHS Research Ethics and Governance have collated information regarding updated processes that all researchers will need to consider.

Click here to find out the process for deviations or minor amendments to research projects.

Points to note

  • All research should be conducted in accordance with the protocol and the  conditions of HREC and site approval and the  NHMRC guidance with respect to the safety and well-being of patients, research participants and their families, as well as healthcare professionals, researchers and other staff involved in patient care and research https://www.nhmrc.gov.au/research-policy/COVID-19-impacts#download.
  • The ongoing voluntary nature of participation in research should be confirmed with the family and documented if they are continuing and/or resuming onsite visits at PCH.
  • Participants should be informed that their decision to continue or not in research will not affect their ongoing treatment or participation in future clinical trials. For full details please refer to  https://www.nhmrc.gov.au/research-policy/COVID-19-impacts#download.
  • Reporting that meets NHMRC requirements for HREC/RGO review  should be reported via RGS refer to https://www.nhmrc.gov.au/about-us/publications/safety-monitoring-and-reporting-clinical-trials-involving-therapeutic-goods.  And https://rgs.health.wa.gov.au/Pages/Research-Ethics.aspx.
  • In accordance with NHMRC direction, decisions to recruit new participants to ongoing trials should take into account the potential benefits and burdens on Australia’s health system and should depend on individual trial factors. The focus should remain on the safety and well-being of those most at risk in our institutions and communities. Any new recruitment should reflect the most current public health advice on social distancing. The CPI/PI or delegated medically responsible person should be making any decisions related to safety.
  • If your study has an investigational medicinal product as an intervention please ensure you have considered any additional safety oversight requirements in the event a participant has confirmation of COVID-19 and ensure there are appropriate study team contact and reporting procedures in place. This is the responsibility of the study team.
  • Any specific amendments to your research project should be managed via the standard review and approval process in RGS (including protocol amendments, relocation of research activity or additional support for equipment such as PPE). Help is available from the CAHS Department of Research team.

The Telethon Clinical Research Centre or Outpatient Clinic D- Research has capacity for research outpatient clinic appointments occurring in line with standard rules, guidelines and procedures based on current advice from CAHS and the WA Department of Health.  

Please only conduct research in approved research clinic locations - not in other clinic areas.

Making Research Clinic bookings

If you are still undertaking research that is approved for ongoing clinical appointments, the booking system is via the standard process. Approved researchers receive specific information about the booking process and requirements for managing research clinic appointments during local area orientation. Adherence to these procedures allows the research department team to continue to support you and provide oversight to the clinical space designated for research appointments. Please follow these procedures as normal, plus any additional guidelines during COVID-19 management.

You can find out details about the current research clinic set up here.

Please discuss any individual circumstances or requirements with Rachel West, CAHS Clinical Nurse Manager - Research. 

PCH Visitor Guidelines

  • Check the full PCH visitor guidelines which includes information regarding entrances to use and visitor requirements. 
  • Please follow the current guidelines around the conduct of research outpatient clinic appointments. 

Additional information and relevant guidelines 

Some initial issues to consider, noting that some links are only accessible on HealthPoint for those with staff viewing access:

  • The use of remote contact as much as possible is encouraged. Consider options to reduce the time of face to face contact such as discussing issues to do with the PICF or appointment expectations via phone in advance of the onsite visit.
  • Visit the WA Department of Health COVID-19 information for health professionals page. It contains a range of information on clinical guidelines, PPE, infection prevention and control in hospitals and testing advice.
  • Visit the CAHS Coronavirus Update (for WA Health user access only) for additional information about the latest Clinical Care Guidelines, Staff Health and Infection Prevention and Control. This provides site specific as well as WA Health information.
  • Research clinic bookings and cancellations made via the usual process. For any clarification or further information, please Rachel West. 
  • In line with usual booking processes please ensure that a CAHS clinician is available onsite for participant review if required.
  • Any incidents associated with the attendance at a clinic (or other relevant context) of a participant known, or later discovered, to be symptomatic should be promptly reported as an adverse event or safety issue.
  • Reporting can be completed via use of the form available for institutional reporting on the website titled CAHS Adverse Event/Serious Adverse Event Notification Form (WA health staff access only). 

Unscheduled Respiratory Tract Infection (RTI) Visits

As per current Outpatient Department guidelines, participants with any acute respiratory symptoms (cough and/or sore throat and/or shortness of breath) cannot attend research clinic at PCH. For studies that require unscheduled visits for the surveillance of respiratory symptoms alternative locations should be considered as per HREC approval e.g. home visits, COVID clinic.

For parents and families 

For parents and families visiting the Research Outpatient Clinic, further information is available that may be of interest:

Medical Records

If medical records are required for review outside a booked outpatient appointment, take into consideration that with the reconfiguration of research clinic we have limited storage space. Please request in smaller bundles via Research Reception as per usual process. When you are notified of their arrival please make it a priority to come and review the same day.
 

Please adhere to the CAHS guidelines and The WA Health Covid-19 Framework for System Alert and Response (SAR).

PPE cannot be provided by the Research Department at this time. 

The WA Health Translation Network (WAHTN) is working to assist in communicating and helping collaboration among their members to minimise the health consequences of COVID-19, capture data and relevant specimens prospectively and initiate trials to help mitigate the effects of the virus. 

With this in mind they have created a webpage to better capture coordination and allow communication between WA researchers. They will be providing access to relevant documents, times of meetings, useful resources and links. Visit WA COVID-19 Research Coordination.

It will be possible for some research to continue during the pandemic response, however there must be appropriate measures to ensure the safety of any active research participants and study team members. 

If you need assistance or advice regarding your research at CAHS please contact the team or specifically CAHS Research Ethics and CAHS Research Governance if needed. 

If your project is an interventional clinical trial and you have not already discussed it with the CAHS Research Ethics and Governance office, please contact the team immediately. 

Ongoing support is available for other research activity however it will be prioritised around COVID-19 related issues and projects. Find out more under For Researchers. There is also capacity within the team for broader research support for aspects such as applications and grants or communications activities. The Research Education Program is also available as an online resource, so take advantage of any available time to upskill or complete mandatory and additional training and education.

 
Many research projects may have shifted to remote work arrangements. In these instances, the existing guidelines for patient safety, data access and management, confidentiality and previously approved protocols still apply. For example, the relocating of patient files to a home is not deemed acceptable.
If in doubt, contact the CAHS Research Support team for advice.

This CAHS Research Support team is still operating and available to provide assistance for new and existing research projects. Priority will be given to COVID-19 related projects and urgent support for ongoing research projects.

Find other information on the For Researchers section of the CAHS website.
 
Email the team  
General Enquiries: CAHS.ResearchAdmin@health.wa.gov.au
Research Ethics: CAHS.Ethics@health.wa.gov.au  
Research Governance: CAHS.RGO@health.wa.gov.au 
Research Grants: CAHSResearchGrantsOfficer@health.wa.gov.au  


Biostatistics support is still available

Researchers are still able to access the Telethon Kids Institute’s process and data management tool REDCap.  

You can register your attendance for a REDCap workshop. 
You can also make bookings for project specific data management support.

 

 
Last Updated: 30/03/2023