Whilst research activity on campus has been reduced, regulatory requirements must still be met in regards to ethics protocols. As part of your research planning and re-scoping, consideration must be given to the overall ethics position, regardless of whether the activity is continuing - remotely or on campus - or has been paused. Of course, the ethics team can provide advice if you have any uncertainty around the ethics requirements of your project.
All of the cCommittees are functioning remotely and seek to remain fully operational. However, it can be challenging to maintain the same level of responsiveness during these remote working arrangements. Please remember that the Committees are all serving the institution as volunteers, including non-technical or specialist members who form an integral part of the committees, in line with regulations. The issues that these Committees normally consider are currently compounded by the present challenges, and often require more deliberation. Research Services Division is working tirelessly to support the committees, and maintain operations. Please be mindful that a lack of consideration and preparedness when interacting with the team can cause unreasonable pressure on all involved.
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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.
The ANU Animal Experimentation Ethics Committee (AEEC) is working hard with the Research Ethics Team to recommence application review cycles based on the usual submission deadlines.
Due to current restrictions and the ever-changing nature of the COVID-19 situation, there may be delays in the review of your application. We request that applicants are respectful and patient during the submission and review process; please keep in mind that all Committee members are volunteers and a number are your fellow colleagues. Every effort will be made to communicate delays directly with applicants.
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 firstname.lastname@example.org 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.
We encourage those with protocols due for renewal to submit their replacement protocol even if work is suspended under the current restrictions. We hope this will minimise a bottleneck in reviews once restrictions are lifted. Protocol start dates can be moved back so that approval time is not lost, please discuss this with the Research Ethics Team.
Where protocols have not been granted an extension previously and are due to expire in the suspension period, the AEEC can consider requests for a one-off three month extension. These must be considered and approved by the AEEC before the current expiry date (as per the usual process). The Research Ethics Team can assist research groups with submissions for three month extensions, please email requests to email@example.com and include the protocol number and expiry date.
The ANU Human Research Ethics Committee (and delegated committees) will be working hard with the Research Ethics Team to re-commence application review cycles, based on the usual submission deadlines (https://services.anu.edu.au/research-support/ethics-integrity/human-ethics-committees-dates).
Please keep in mind that not all Committees are running at full capacity. We request that applicants are polite and patient during the submission and review process - committee members are your fellow colleagues.
Due to the ever-changing nature of the current situation and the increased risk environment for research participants, the review of applications is taking longer and there may be delays in the review of your application. Every effort will be made to communicate delays directly with applicants
Priority will continue to be given to applications/variations that:
Are required for research directly related to COVID, or
Are essential variations to existing protocols that will minimise risk/distress to participants.
For these priority submissions to be actioned appropriately, please email firstname.lastname@example.org to alert the Ethics Team ahead of submission, and include "Priority Submission" in the subject line.
The current 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; variations will not be accepted.
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.
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.
The current pandemic situation is highly stressful for everyone, and in Australia this comes after an unprecedented bushfire season.
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.
This information applies to all research groups who have been approved by the Deputy Vice-Chancellor (Research and Innovation) to continue work involving Genetically Modified Organisms (GMOs). Relevant information is below and is also available on the OGTR website.
Please note that all work with GMOs that has been 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.
Information for facility managers and those continuing work with GMOs in certified facilities
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"
The closing date for applications to the following schemes have been extended. The new closing dates are:
- 2021 Linkage Infrastructure, Equipment and Facilities (LIEF) 29 April 2020.
- Special Research Initiative (SRI) for Australian Society, History and Culture 6 May 2020.
Please note that these new dates apply to all applications, administering institutions do not need to submit extension requests.
- 2021 Clinical Trials and Cohort Studies scheme has been delayed by several months. The new closing date will be 25 November 2020.
- 2021 Ideas Grant scheme has been delayed by five weeks. The new closing date will be 10 June 2020. The applications will be assessed with a streamlined peer review process. NHMRC has asked that if your Ideas Grant application is already close to being finalised, wherever possible please don't wait until the extended deadline to submit.
- 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.
- 2020 Partnership Projects scheme Peer Review Cycle 1 has been delayed. The scheme will now open on 1 April 2020.
- The new Special Initiative in Mental Health scheme will close 15 July 2020.