Research into COVID-19
Priority review will continue to be given to applications that are:
- required for research directly related to the COVID-19 response, or
- essential amendments to existing protocols that will minimise risk to animals.
For these priority submissions to be actioned appropriately, please email to alert the Ethics Team ahead of submission. Please include "Priority Submission" in the subject title.
The coronavirus pandemic may be seen as an opportunity to conduct new research related to COVID-19 and to expand the scope of existing research to incorporate new work related to COVID-19. Any COVID-19 elements that are not fundamentally aligned with the original application must be submitted as a new application.
Fieldwork during COVID-19
Fieldwork is a key component of humanities, arts and social sciences (HASS) research, and usually involves travel and /or face-to-face interaction. However, COVID-19 has had significant impact on field research activities. Restrictions on travel, as well as limited access to research locations and to social cohorts/communities, require researchers to approach fieldwork design and practice in new and innovative ways.
The ANU has developed a series of protocols and guides to assist ANU researchers and higher degree by research students who intend to conduct fieldwork while COVID-19 restrictions are in place.
The ANU will permit the re-commencement of fieldwork in all Australian states and territories subject to the following conditions:
- Required Research Fieldwork Protocols are met.
- A COVID-19 Fieldwork Plan has been approved.
- A WHS Risk Assessment has been completed and approved.
- A travel form and all supporting documentation have been approved in the ANU Travel System.
Details on these requirements are provided in the document: Research Fieldwork Protocol. This document contains the list of required ANU protocols for research involving fieldwork and a template for the COVID-19 Fieldwork Plan.
The process for having fieldwork approved can be found in the: Fieldwork Decision-making Flowchart.
In addition, the university has developed a Guide to Fieldwork Strategies in Response to COVID-19 to help inform researcher decisions with regards to Fieldwork.
The risks related to COVID-19 are dynamic, and restrictions and regulations are likely to remain in a state of flux over the life of the pandemic. This document will be reviewed quarterly by a sub-committee of the University Research Committee to assess the current COVID-19 environment and address any emerging issues.
All University staff, students and visitors are responsible for maintaining their own health and safety, and that of other individuals across the ANU campus. Staff, students and visitors must understand and comply with the University Guidelines when participating in ANU activities.
A set of guidelines and a checklist have been developed to assist with restarting animal based research effectively. The guidelines were developed in close consultation with animal facility managers and aim to ensure consideration has been given to maintaining high levels of animal welfare during the re-start period. Please note that you are not required to submit the checklist or other documentation related to the re-start to the Ethics Office - this will be managed via processes within your School.
In line with normal practice all projects must be undertaken with appropriate acknowledgement and management of the risks involved. Any new protocol or variation must clearly consider the risks associated with the work, including the likelihood that risks will escalate over the course of the work. Effective strategies must be developed to minimise harm to participants, and the research must be demonstrated to have realistic benefits that significantly outweigh any potential harms. Failure to acknowledge, address and manage the risks appropriately will result in your application being returned to you for modification. In turn, this delays the turnaround time for all applicants.
There is a real risk of psychological harm in asking participants questions related to COVID-19. Further, as the COVID-19 situation evolves rapidly, the risks associated with the research may escalate quickly and require researchers to invoke stronger mitigation strategies, including suspending the research if the risks become unmanageable.
Project leaders must be vigilant and prompt in monitoring and reporting on their research if adverse events occur. The Human Research Ethics Committee (and delegated committees) will hold both new protocols and variations to existing protocols to the usual high standard expected from the ANU.
Re-introduction of face-to-face research
As part of restarting face-to-face research, it is a requirement that all relevant COVID-19 related social distancing and hygiene practices are implemented.
With research activity increasing on campus, regulatory requirements must still be met in regards to ethics protocols, and any changes in government restrictions will immediately override any protocols in place around resumed research. Any new work proposed would need to provide a strong argument as to why face-to-face methods are integral to the research as opposed to other approaches, which would minimise in-person interactions.
All researchers looking to resume face-to-face research must develop contingency plans should restrictions tighten again. Careful consideration and planning is required to avoid placing participants at risk for little or no benefit - if the situation changes and data collection methods have to be modified partway through a project, this could potentially render early collection with differing methods unusable. Contingency plans should also allow for immunocompromised individuals to participate, and/or those potential participants who would be uncomfortable with face-to-face methods but would like to be involved.
Variations that cover more than one existing protocol
Consideration may be given to variations that can be applied to more than one existing protocol in a School or Centre.
This would require coordinated development of COVID protocols detailing the changed research processes, with a high level of support and oversight from local area Directors and other senior managers.
General guidance for Schools and Centres considering a blanket approach to variations is:
- the need for face-to-face contact would need to be justified - that is, if the research could be carried out using remote means like Zoom/Skype then that should be the first option given that this minimises risks to participants and research staff
- if face-to-face techniques are needed, strict protocols need to be developed by the local area that ensure restrictions around gatherings, distancing and hygiene are followed and researchers would need to sign on that these measures would be adopted
- all contact details must be retained in case of infection requiring contact tracing, participants must be informed and consent prior to attending in person, where consent cannot be obtained the face-to-face interaction cannot go ahead
- Research involving Aboriginal and Torres Strait Islander people will not be considered as part of any blanket arrangement; evidence of agreement from the participants that the change is wanted by them must be considered on a case by case basis
Applications from Masters, Honours and HDR students must be fully reviewed by the supervisor prior to submission and must be in line with University communications concerning that student group - an email from the supervisor indicating the review is complete should be uploaded to the documents section of the application in ARIES.
Following further consultation, the University has clarified the information relating to research with Indigenous participants.
In many cases, Indigenous communities are likely to be feeling the effects of the current crisis to a higher degree. To limit the spread of COVID-19, the University is advising researchers who are conducting engagement or approved research on-country and in remote communities to ensure that these communities are still willing to participate. From an ethical perspective the immediate needs of participants is paramount, and you must ensure that your participants are informed of the changing circumstances, and consent to the research/engagement continuing under the new circumstances as might apply in their own jurisdictions.
In terms of ongoing engagement or research that can be conducted remotely, the present situation may make research less of a priority for most participants and the University needs to anticipate, acknowledge and respect this. If participants remain willing, then the University is supportive of research activities conducted remotely, particularly research determined as beneficial by the communities themselves.
Researchers should consider a range of risk management processes for all research applications that have direct contact with Indigenous peoples, such as interviews and fieldwork. People living in rural and remote areas generally may not have conference call facilities of a similar capacity to those in urban areas to support 'remote' research arrangements. Further, we must respect the sensitivity and agency of these communities to determine how, when and to what extent they wish to engage with ANU, while we simultaneously ensure we mitigate risk of transmission. ANU staff and researchers must ensure that they are complying with all relevant laws and policies as they apply in the various States and Territories in which research is conducted, particularly as we, as a nation, manage the complex issues arising from the current pandemic.
Research with genetically modified organisms (GMOs)
The University Recombinant DNA Monitoring Committee is continuing to accept applications for dealings involving the use of GMOs, which are reviewed out of session. For submissions to be actioned appropriately, please ensure applications are sent via email to email@example.com a minimum of 6 weeks before the expiry of your existing dealing, or for new dealings, 8 weeks before the anticipated start of your work.
Information from the Office of the Gene Technology Regulator (OGTR)
This information applies to all research groups who have been approved by the Deputy Vice-Chancellor (Research and Innovation) to continue work involving GMOs. Relevant information is below and is also available on the OGTR website.
Please note that all GM work approved to continue must only be conducted by persons who have completed the required Biological Safety and Gene Technology Practices training. Undergraduate (non-Honours) students will not be able to continue working with GMOs, as they have not completed the training and the requirement of constant supervision will no longer be possible while maintaining social distancing practices.
Information for facility managers and those continuing work with GMOs in certified facilities
While some flexibility regarding time frames for annual PC2 inspections may be appropriate, inspections are considered by OGTR to be a critical risk-management tool. As such, full exemptions from this requirement must be submitted via the Ethics Office to OGTR and are unlikely to be granted.
If no GM work is currently happening, facility managers can contact firstname.lastname@example.org to apply to suspend certification until the inspection can be carried out.
Where supply shortages occur (for example, decontamination solutions, PPE and consumables), OGTR have stated that:
"Institutions may consider the use of alternative decontaminants. The TGA instructions for disinfectant testing may be helpful and provides guidance on the testing of the effectiveness of decontaminants. Please note that this guidance document uses 'disinfectant' whereas 'decontaminant' is used in guidelines that are issued by the OGTR. AS/NZS 2243.3:2010, Appendix F, is a recommended source of information when selecting and using chemical decontamination agents. Please be aware that work should not proceed where you cannot provide a decontaminant that is effective against the GMO being used in the lab."
When conducting experiments involving the use of GMOs under an approved dealing, research groups must have all the equipment, consumables, PPE and approved disinfectants and/or sanitisers to complete their experiments prior to the commencement of work. Information regarding possible supply chain interruptions is available from the Association of Biosafety for Australia and New Zealand.
If facility managers have any concerns regarding their ability to meet the conditions of PC2 certification, please email email@example.com as soon as possible.
Where there is an inability to test/calibrate decontamination or containment equipment, OGTR have indicated 'The Physical Containment Guidelines stipulate annual maintenance on a set of equipment to ensure it is functioning effectively. If this annual maintenance cannot be achieved, a risk assessment should be conducted and a risk management strategy sent [to firstname.lastname@example.org so that it can be submitted to OGTR as part of a Certification Variation request]. The risk management strategy could include considerations of alternative validation measures such as including spore tests in autoclave runs and storing the waste until it has been demonstrated that the kill was effective, or build in a safety margin by increasing time or temperature in autoclave runs.'
Please note that if any changes to testing or calibration are required, facilities should email email@example.com. No changes are to be made without prior approval.
Information for DNIR licence holders
The following is communication from the OGTR to DNIR licence holders, and is also available on the OGTR website:
"The OGTR appreciates that important work is being conducted under licences and that licence holders wish to continue this work. Licence conditions must be complied with even in these difficult times.
General Principles for licence holders:
- Your priority is to ensure that GMOs or viable GM material are not dispersed and that the work is being conducted safely.
- Consider alternative approaches to your standard work practices that still ensure that you meet licence conditions.
- You may wish to update your contingency plans and SOPs to ensure that licence conditions will continue to be met and risks are managed under a variety of circumstances. These include:
- effectiveness of current containment requirements
- impact of reduced workforce availability
- impact of restrictions on travel/transport of GMOs
- impact of travel restrictions on conducting inspections
- complying with reporting obligations."
ARC & NHMRC update
- 2021 Clinical Trials and Cohort Studies scheme has been delayed by several months. The new closing date will be 25 November 2020.
- 2021 Synergy Grants scheme has been cancelled.
- 2021 Investigator Grants scheme outcomes are expected soon.
- 2021 Targeted Call for Research into End of Life research and translation is delayed until further notice.