COVID-19 and Human Research Ethics

COVID-19 Impacts to research projects

Update at 16 November 2020

All research activities that can be conducted remotely should be enacted remotely from close of business on Wednesday 18th November. As was the case in March, on-campus research activities can continue where research continuity plans, risk assessments and appropriate physical distancing measures have been put in place. Requests for on campus research and for off campus field work—including by research degree students—should be signed off by the applicable Dean of Research and the DVC: Research & Enterprise.

Changes to existing or new projects due to COVID-19

The following information relates to changes to existing or new projects that might be required as a result of COVID-19. Please refresh and check this page regularly, as there may be new updates and/or modifications to the information provided.

Note that student researchers must discuss COVID-19 implications for their research projects and applications with their supervisors, regarding new applications or variations to existing projects.

If required, please contact a Research Ethics Advisor, or email humanethics@unisa.edu.au, for further guidance and discussion.

Further information on this page includes:

  • How to vary an existing approved project
  • Applications currently under review
  • New applications not submitted yet

HOW DO I VARY AN EXISTING APPROVED PROJECT?

Please note: if you originally received approval from a non-UniSA Human Research Ethics Committee (HREC), you must apply to that HREC for approval to vary your project, and then submit the variations and approval from the other HREC to UniSA’s HREC system for ratification.

If you need to modify your approved project for any reason, including COVID-19, you must submit a Project Variation Form in the usual way. Resources have been increased in order to manage these variations as efficiently as possible. Simple variations may only take a day or two for ethical review and approval, while more complex variations may take longer. Timeframes will also depend on the number of variations being reviewed at a particular time. If you have a critical timeline to meet, please state the timeline and reasons, so that this may be considered during review of your variation request.

As well as the Project Variation Form, you must submit any relevant modified documents at the same time, for ethical review and approval, e.g., recruitment material, Participant Information Sheets, Consent Forms, questionnaires, and other data collection / research tools, etc. These documents will need to include new or modified wording to cover the project variations, relating to, e.g., changes to methodology or data storage, additional consent requirements, etc.

Please also consider any other changes to your project and documentation that might now require variation, and therefore ethical review and approval.

And please consider any implications for insurance cover for your project.

As always, you must receive final approval for any variations before implementing them.

If your in-person research is not approved to proceed at this time, as described in the note at the top of this webpage, you may be able to change to audio- or video-based approaches, such as telephone, Zoom or Skype..

Participant Information Sheets can be provided to participants via email.

Consent forms can be returned by participants via email, or a participant’s verbal consent can be recorded by researchers at the start of an interview or focus group session.

Issues associated with access of participants to relevant technology will also need to be considered and addressed.

If there is a risk of participants becoming distressed during data collection you will need to consider how to adapt your Distress Protocol to a telephone or online environment.

If your project involves in-person contact with participants, and has been approved to proceed as described in the note at the top of this webpage, please consider the numbered points below.

Please also note: Researchers must comply with all relevant federal and state government requirements regarding COVID-19, and must also monitor these requirements for any additions or changes. Please refer to these webpages:

https://www.australia.gov.au/

https://www.health.gov.au/resources/collections/novel-coronavirus-2019-ncov-resources

https://www.sa.gov.au/covid-19/home

If in-person / face-to-face contact is absolutely necessary for your project AND you have the relevant University approvals to proceed (see above), please consider:

  1. If you still have permission to conduct your project in the same selected environment, e.g., a school, workplace, health centre, residential home, etc.; and
  2. How you will manage the safety of both participants and researchers. For example, please consider:
    1. Not including participants in particularly vulnerable groups, such as those over 60 years old, and those with impaired immune systems and other chronic health conditions (although please note that infected people at any age – possibly excluding those below 10 years old – can develop serious illness and die from this disease).
    2. Screening participants by asking questions regarding:
      • Any existing direction to self-isolate or self-quarantine
      • COVID-19 symptoms, e.g., fever, dry cough, fatigue, difficulty breathing
      • any contact they have had with people who have tested positive for the SARS-CoV-2 virus, the causative agent of COVID-19
      • recent trips overseas or interstate
      • You may wish to provide participants with government information regarding COVID-19; and any new questionnaire will require approval as part of your overall variation request.
    3. Social distancing measures, as directed by the government, e.g., all people involved to keep 1.5 to 2 metres distance from each other at all times, or 4 square metres per person indoors
    4. Regular handwashing, and disinfecting of surfaces
    5. The use of Personal Protective Equipment (PPE), such as masks and gloves.

If your clinical research or clinical trial has been approved to proceed as described in the note at the top of this webpage, please download and consider this detailed guidance document from the NHMRC:

https://www.nhmrc.gov.au/research-policy/COVID-19-impacts#download

If you are changing the way you involve participants and collect data, and/or you are adding time and questions for COVID-19 screening, you will need to complete a Project Variation Form.

If you are changing your data collection method, please consider:

  • Variations to seek approval for audio- or video-based discussions and recording
  • Potential third-party transcription of audio or video recording, and associated confidentiality agreements
  • Data security
  • Data confidentiality while stored on a third party software platform
  • Data access for approved co-researchers

If your project / recruitment / data collection is delayed, you do not need to inform the ethics office of this delay; it can just be noted in your annual or final progress report.

However, if you require an extension to your current ethics approval period for any reason, please follow the guidance on this webpage.

If you have obtained ethical approval for your research project but it will not now commence or proceed due to COVID-19, or for any other reason, please submit an Annual Report-Extension-Project Completion form, available from this webpage, and ensure that you complete Section 3 as well as other relevant sections of this form. Please send the completed form to humanethics@unisa.edu.au for processing and record-keeping.

APPLICATIONS CURRENTLY UNDER REVIEW

You should review your application to determine if you need to modify the application because of COVID-19, to address Government and University requirements, and/or the types of variations described above.

Student researchers should discuss COVID-19 implications for their research with their supervisors.

NOTE: if you need to make modifications, this will not cause delays with the processing/approval times but will assist the ethics team and reviewers in making the process more efficient.

If your application has been submitted and is:

Being reviewed by your Supervisor, the RIS Human Research Ethics team or the HREC Ethics Review Group

During the review process, the reviewers will ‘screen’ for these issues. However, if you are already aware that there are issues to be addressed (but you are currently unable to ‘edit’ the application form), please contact the human ethics team (humanethics@unisa.edu.au) to request that the application be reverted to allow you to make any modifications.

The specific research design and methodology questions that should be reviewed are here.

Being updated by you after review (by your Supervisor, the RIS Human Research Ethics team or the HREC Ethics Review Group)

The application has been reverted back to you so you should be able to ‘edit’ the application form accordingly.

The specific research design and methodology questions that should be reviewed are here.

Planned research design and methodology

  • If your planned research design and methodology requires physical proximity with participants AND IS approved as described in the note at the top of this webpage:
    • Question 71.1 – select “yes” as there are infection risks for participants and researchers. A plan to manage this risk and comply with government requirements must be developed and stated clearly in an attachment to your application
  • If your planned research design and methodology requires physical proximity with participants BUT IS NOT approved as described in the note at the top of this webpage, you can still progress with the ethics review but will need to clearly indicate in your application that you will only conduct this research at a future time when the current restrictions are no longer in place
  • If you wish to modify your planned research design and methodology to incorporate online methods of data collection:
    • Question 14.22 – tick ‘Other’ box. Details of online data collection methods should be entered in the text box that will appear. In addition, the same data collection methods should be stated in response to questions 5.5 and 15.3.1 of the online form.

Please contact humanethics@unisa.edu.au for guidance and support.

NEW APPLICATIONS, NOT YET SUBMITTED

If your ethics application is still under development, please consider if you need to modify it because of COVID-19, to address Government and University requirements, and/or the types of variations described above.

Student researchers should discuss COVID-19 implications for their research with their supervisors.

The specific research design and methodology questions that should be reviewed are:

  • If your planned research design and methodology requires physical proximity with participants AND IS approved as described in the note at the top of this webpage:
    • Question 71.1 – select “yes” as there are infection risks for participants and researchers. A plan to manage this risk and comply with government requirements must be developed and stated clearly in an attachment to your application
  • If your planned research design and methodology requires physical proximity with participants BUT IS NOT approved as described in the note at the top of this webpage, you can still progress with the ethics review but will need to clearly indicate in your application that you will only conduct this research at a future time when the current restrictions are no longer in place
  • If you wish to modify your planned research design and methodology to incorporate online methods of data collection:
    • Question 14.22 – tick ‘Other’ box. Details of online data collection methods should be entered in the text box that will appear. In addition, the same data collection methods should be stated in response to questions 5.5 and 15.3.1 of the online form.

Please contact humanethics@unisa.edu.au for guidance and support.