COVID-19 Guidelines for human research on campus
Commencing or resuming on-campus research involving people
- Complete a COVID-19 risk assessment, including risk mitigation strategies (please take note of the risk assessment table below);
- Complete the Return to campus research risk assessment proforma;
- Submit modification request/new application to Human Ethics Committee with a justification why the face-to-face approach is required and cannot be conducted remotely. The above mentioned COVID-19 risk assessment and Return to campus research risk assessment proforma need to be provided as part of your modification request/new application;
- Once ethics modification/new ethics application approval is received, projects will require Head of School and APVCRIE approval as part of the priority research process. You will need to present your Campus research proforma, ethics approval and Return to campus research risk assessment proforma,
- LTU COVID safety protocols need to be communicated to the participants prior to entering campus and this information should form part of the Participant Information Statement.
Research modifications to accommodate COVID-19 requirements
- The Ethics Committee and Principal Investigators should be undertaking contingency planning to address the potential impact of COVID-19 on researchers and research participants.
- Review of your current projects should be considered, and if changes are required, are done so via a modification request.
- For new projects, ensure your projects contain contingencies during COVID-19 as well as post-COVID-19.
- Contingency planning should include:
- priority: assessment of the importance of and the risks associated with continuing the research study as designed or with necessary modifications. Responses could include continuing the research study in its present form, conducting the research in a modified form, postponing the research or closing the research.
- participation: assessment of the ability of participants to participate in the research study in accordance with protocol requirements and consideration of alternative models for participation that would not compromise the integrity of the research study.
- capacity: assessment of the resources available for continuing the research study, including research staff, research support staff, other support staff, space, equipment, supplies, etc. For health and medical research, a component of a capacity assessment will be consideration of the need to re-allocate research staff to clinical care and other areas of patient support.
- Contingency planning will need to be an ongoing process.
- Please also visit below intranet sites for additional resources:
| Risk | Mitigation Strategies |
|---|
| Participant has COVID19; could infect researcher | Prior to study visit - Prior to participants attending a study visit, researchers call the participants to explain the risks of COVID-19, and precautions that have been taken, and reinforce that participation remains voluntary and they are under no obligation to attend the student visit.
While attending the study visit - Test temperature of participant on arrival at campus – if febrile do not proceed and advise to have testing
- Participant to fill in a COVID19 screening form on arrival and, if any symptoms, do not proceed and advise to have testing
- Participants complete hand hygiene procedure on arrival and staff repeat this procedure at the same time
- Participants and staff wear gloves after hand hygiene procedure
- Cleaning of all apparatus and equipment before and after each participant attends laboratory
- If appropriate, participant and staff members wear PPE (including disposable eye protection) gowns and masks
- Maintain physical distancing by keeping at least 1.5 metres between self and others at all times.
|
Researcher may have undiagnosed COVID19; could infect participant | - Test temperature of staff on arrival at campus – if febrile do not proceed; advise to have testing and go home
- Staff complete hand hygiene procedure and wear gloves after hand hygiene procedure.
- If appropriate, wear PPE (including disposable eye protection) gowns and masks
- Maintain physical distancing by keeping at least 1.5 metres between self and others at all times.
|
| COVID19 virus in campus laboratory or on equipment | - Notify environmental services that this laboratory / area of campus will be visited by participants / patients from the community and will need daily cleaning.
- Researcher to additionally clean all equipment and sterilise all surfaces the participant comes into contact with before and after each use; use disposable testing products where possible.
|
Commencing or resuming community-based research involving people
- Check DHHS website to confirm if the setting you wish to conduct your research in has resumed for face-to-face visits;
- Complete a COVID-19 risk assessment, including risk mitigation strategies (please take note of the risk assessment table below);
- Submit modification request/new application to Human Ethics Committee with a justification why the face-to-face approach is required and cannot be conducted remotely. The COVID-19 risk assessment needs to be provided as part of your modification request/new application.
- Once ethics modification/new ethics application approval is received, projects will require Head of School and APVCRIE approval as part of the priority research process.
Research modifications to accommodate COVID-19 requirements
It may be necessary to make modifications to your approved ethics application or draft ethics application to accommodate COVID-19 requirements:
- The Principal Investigators, and where appropriate industry partners, should be undertaking contingency planning to address the potential impact of COVID-19 on projects and research participants.
- Review of your current research should occur. If changes are required, please submit a modification request to the approving Ethics Committee (this may not always be La Trobe). Note: If the project is externally approved, the La Trobe Ethics Committee should be notified of the modification once approved by the external Ethics Committee.
- Please note, based on current government and/or organisational restrictions, sometimes the project may be delayed or postponed.
- To reduce the number of potential future modification requests it is recommended you outline contingency plans during COVID-19 and post COVID-19 (if applicable).
- Contingency planning outlined in modification requests and new ethics applications should include:
- Priority: Assessment of the benefits and risks associated with continuing the research either as designed or with necessary modifications.
- Participation: Assessment of the capability of participants to participate in the research and consideration of alternative models for participation that would not compromise the integrity of the research study.
- Capacity: Assessment of the resources available for continuing the research during COVID19, including research staff, research support staff, other support staff, space, equipment, supplies, etc.
Contingency planning will need to be an ongoing process, that complies with evolving national and state-specific COVID-19 measures (DHHS COVID-19 website)
| Risk | Mitigation Strategies |
|---|
| Participant may have undiagnosed COVID-19 and does not know; could infect researcher | Prior to study visit- Prior to participants attending a study visit, researchers contact the participants and/or relevant community organisations to explain the risks of COVID-19, and precautions that have been taken, and reinforce that participation remains voluntary, they are under no obligation to attend the study visit, and can withdraw at any time.
- Screening Questions: does participant have flu symptoms/ traveled interstate or overseas/ been in contact with confirmed COVID-19 cases…
While attending the study visit- Participants complete hand hygiene procedure on arrival and staff repeat this procedure at the same time.
- Cleaning of all apparatus and equipment before and after each participant uses the equipment.
- If appropriate, participant, researchers and/or staff members wear personal protective equipment (PPE), including disposable eye protection, gowns, gloves and/ or masks.
- Where possible, maintain physical distancing (at least 1.5 metres between self and others, including groups).
|
| Researcher may have undiagnosed COVID-19; could infect participant | Prior to attending the study visit- Researcher does not attend if they meet the testing criteria for COVID-19 and/or is awaiting test result
While attending the study visit- Participants complete hand hygiene procedure on arrival and staff repeat this procedure at the same time.
- Cleaning of all apparatus and equipment before and after each participant uses the equipment.
- If appropriate, participants, researchers and/or staff members wear personal protective equipment (PPE), including disposable eye protection, gowns, gloves and/ or masks.
- Where possible, maintain physical distancing (at least 1.5 metres between self and others, including groups).
|
| COVID-19 requirements at other organisations | - Check with the organisation if they have any specific COVID-19 requirements in addition to the ones listed above as well as guidelines in place in the relevant state and in the organisation where the state is located.
|
Research Specific Risks (list) | - Add mitigation strategies specific to the research
|
Zoom vs MS Teams for data collection
The advice from La Trobe Information Services is that Zoom can be used for non-confidential matters (including research). However, anything that is highly confidential should be conducted via Teams. Tips on how to increase security using Zoom can be found at on the La Trobe Information Services website.
To use Microsoft Teams the recipient must have an Office 365 account (this account doesn’t have to be a La Trobe Office 365 account for it to work). This means some research participants won’t be able to log in via Teams if they do not have a 365 account. The Ethics Committee should take this into consideration in addition to the highly confidential nature of the research interview when reviewing projects.
Cisco Webex is also another secure option. This can be used by people external to La Trobe without any signin, however your research participants will need to download the Cisco app.
eConsent
To replace paper Participant Information Statement and Consent Forms with Electronic informed consent (eConsent), eConsent must provide the same information, but in an electronic format. It is important to note that eConsent does not replace the important discussion between the participant and research team about the nature of the project and what the participant will be asked to do and why.
eConsent can be implemented by La Trobe research staff and students in the following ways (please note this advice was based on TransCelerate eConsent guidelines):
- Use of RedCap (contact redcap-admin@latrobe.edu.au) ; AND
- Telephone/Video Call; OR
- Use videos and/or Audio over your PICF (see TransCelerate eConsent guidelines)
Good clinical practice (GCP) training
GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting of clinical trials that involve human participants. It is recommended that anyone involved in the conduct of research involving human participants consider completing this training.
There are currently two free options provided to all La Trobe staff and students:
1. Face-to-face GCP training (currently via Zoom) - this training is delivered by Human Ethics and focuses on the application of GCP principles relevant to the research that occurs at La Trobe. Below are the upcoming dates:
| Date | Time |
|---|
| Monday 27th July | 12pm - 12.30pm |
Please contact Human Ethics to book into a session. Due to the interactive nature of the training there is a limit of 8 attendees per date, this will allow discussion and questions during the training. The training generally takes about 3hrs however an extra 30 minutes has been allocated to allow for discussion if needed. Please suggest a couple of dates that would suit. Note: a minimum of 3 attendees will be required for a session to run.
Note: Additional dates will be added according to need.
2. Online GCP training (provided by Genesis Research Services) - this is a self-paced online training option with a focus on the application of the GCP principles in a global setting.
Participant Reimbursement
Do I need human research ethics approval?
All La Trobe staff and research students who conduct research projects will require human research ethics approval if they intend to conduct research or research activities involving the following:
- engagement with human participants;
- collection and/or use of previously collected biological material (e.g. obtained from person including tissue, blood, urine, sputum and any derivative from these including cell lines. This does not include non-human biological material such as micro-organisms that live on or in a person;
- artefacts or archival material;
- irrespective of the level of risk of the activity, researchers must have valid human research ethics approval in place prior to commencement of research (National Statement, Chapters 4 and 5) and Australian state-based Human Tissue Acts).
Types of activities that may not require ethics approval
Conducting quality assurance (QA) and evaluation activities does not required human research ethics approval even when such activities may utilise research methodologies. An activity where the primary purposes is to monitor or improve the quality of service delivered by an individual or an organisation (e.g. to improve the quality of a teaching program or instructional method) is a QA activity. Evaluation is used to make judgements, usually about the effectiveness, efficiency and/or appropriateness of an activity. In cases where a QA or evaluation activity forms part of or transforms into research, a human research ethics approval must be acquired. A useful rule of thumb is: if the findings are only to be disseminated 'in-house' then ethics approval is probably not necessary, but if they are to be presented to wider audiences via conferences, seminars or journals then ethics approval is almost certainly needed.
Regardless of whether an activity is research, QA or evaluation, all participants involved in the activity should receive optimal care and any potential risks, burden, inconvenience or possible breach of their privacy must be carefully considered and addressed.
If you are unsure whether or not ethics approval is needed, please contact Human Ethics.
How do I judge if my research project is negligible risk, low risk or above low risk?
La Trobe has streamlined its processes to use the same application form, project description, templates and closing dates for all projects, regardless of level of risk. This reduces paperwork in the event that your project risk level is re-classified and ensures your project is reviewed via the fastest routes to receive ethics approval. There are provisions within the National Statement (Chapter 4 and 5) that allow negligible and low risk research to be reviewed and approval by a body other than the Humans Research Ethics Committee. At La Trobe, both the negligible and low risk applications are reviewed by one of the College based Low-Risk Sub-Committees.
Risk is determined by reviewing the potential harm and the steps you have put in place to reduce its impact and ensure safety (we call this risk mitigation strategies) to the following people:
- Participants (e.g. risk of study procedures such as ionizing radiation, bio specimen collection, drugs/devices, psychological risk, cultural risks);
- Researchers (e.g. safety to researchers such as wearing personal protective wear, safety when conducting research activities at home or in public spaces) and;
- University (e.g. financial and reputational)
The level of risk of a research project should be outlined in the project description and can be gauged by taking into account (National Statement, Chapter 2.1):
- the kinds of harm, discomfort or inconvenience that may occur;
- the likelihood of these occurring; and
- the severity of any harm that may occur and your risk mitigation strategies to reduce the risk
The expression 'low risk research' describes research in which the only foreseeable risk is one of discomfort. Research in which the risk for participants is more serious than discomfort is not low risk.
The expression 'negligible risk research' describes research in which the only foreseeable risk is of harm or discomfort; and any foreseeable is no more than inconvenience.
Both negligible and low risk human ethics applications can be reviewed by the relevant College Low Risk Human Research Ethics Committee. The information provided in your application form and project description is used to judge the level of risk. Please Human Ethics if you would like advice regarding your project's level of risk.
Above low risk human ethics applications, that is, research in which the risk for participants is more serious than discomfort, must be reviewed by the University Human Research Ethics Committee.
What are the review pathways for negligible risk, low risk and abow low risk human research?
In accordance with the National Statement (sections 5.1.18 - 5.1.21), La Trobe has established two review pathways, one for negligible low risk, the other for above low risks research. Closing dates, applications forms, project documentation (e.g. advertisement, Participant Information & Consent forms, study tools) and level of detail remain the same. The only difference between the pathways is the committee who review the application. At time of submission, you can indicate which pathway you think is most appropriate, however the level of risk will be judged by the Human Research Ethics Office, alongside the Chair of the committee, and downgraded/upgraded as deemed appropriate in accordance with the National Statement. At all stages, we will communicate with you which committee will be reviewing your application and the date you can expect to hear an outcome.
The pathways and committees review are as follows:
How long do I have to wait to receive ethics approval?
We will aim for all projects to obtain ethics approval within 30 business days of the closing date. Business days are calculated as the number of days between the advertised closing date to the day the Principal Investigator (PI) is sent the letter detailing the outcome of the ethics review. The outcome may be that revisions are needed. the clos starts again when the PI submits their response to the letter of outcome.
When can I commence my research?
You cannot start recruitment or data collection until you have received written approval from the Human Research Ethics Committee (HREC) or one of its Low Risk Sub-Committee (SHE or ASSC).
Consultations and literature reviews to determine the scope of your project should occur prior to applying for ethics approval.
If your project requires approval from another jurisdiction (e.g. hospital, school, department of defence etc) please following the information under 'I have received ethics approval from another external organisation do I still need La Trobe ethics approval?'.
If your project involves overseas fieldwork, researchers must obtain ethics from La Trobe university and demonstrate they they comply with any of the following:
I have received ethics approval from an external organisation. Do I still need La Trobe ethics approval?
La Trobe has adopted the recommendation of the National Statement (Chapter 5.3) to minimise the duplication of ethical review and therefore recognises approval issued by other NH&MRC-registered HRECs and their delegated negligible and/or low-risk review bodies. This means that La Trobe staff and students undertaking research do not need to seek ethical review by the La Trobe HRECs or its Low Risk Sub-Committees if their project has been approved by another NH&MRC-registered HREC or their delegated negligible and/or low-risk review bodies. However, to maintain insurance coverage, any projects involving La Trobe staff and research students must be registered via the externally approved projects pathway.
In some cases, you may need to seek multiple approvals from HRECs. An example includes conducting research in Schools in Victoria and New South Wales. Ethics approval must be given by the Department of Education in each state, and depending on the state, sometimes they will ask La Trobe to issue approval first. For these instances please contact Human Ethics or call +61 3 9479 1443 to discuss.
Can I receive retrospective approval?
La Trobe HREC and its Low Risk Sub-Committees do not provide retrospective approval for any research conducted without ethics approval or under an expired ethics project.
What is the approval period?
The HREC and its Low Risk Sub-Committees can provide approval for up to five years.
Can I extend my approval period?
The Principal Investigator can apply for an extension before the end date of an approved project. A project modification form must be completed to request an extension of ethics approval. Please note that:
- Requests for extension can only be granted during the approval period for which the project already has approval.
- Retrospective extensions will not be granted.
- The modification requestioned must remain within the scope of work of the original approved research project.
Extension up to 12 months
A 12 month extension submitted on a modification request form can be granted to complete recruitment and data collection. Please note that:
- Additional extensions cannot be requested once an extension has been approved.
- Projects with a high number of modifications submitted during the initial approval period may be advised to provide a new application.
- Requests for extensions can only be granted if all annual reporting and approval conditions have been met.
Extensions exceeding 12 months
In general, extension for periods of longer than 12 months should be submitted as a new application. Special circumstances (e.g. project paused due to unforeseen reasons) may be considered by the HREC/Sub-Committee on the condition that appropriate reason or justification is provided. The approving HREC/Sub-Committee may be grant a 3-month extension to allow the researcher additional time to generate a new application for ethical review.
If you need any assistance, please contact Human Ethics.
If you have any additional questions please contact Human Ethics or call +61 3 9479 1443
