Human Research Ethics Applications

The exemptions process is currently under review and any queries should be forwarded to hrec@adelaide.edu.au

'Lower risk research' describes research which satisfies both of the following conditions:

• There is no foreseeable risk of any harm to participants and others; and any foreseeable risk is no more than discomfort. Discomfort can include, for example, minor side-effects of medication, the discomfort related to measuring blood pressure, and anxiety induced by an interview.  Where the risk, even if unlikely, is more serious than discomfort, the project will require full review.
• It is not included in the following categories:
  • the use without consent of personal information in medical research, or personal health information
  • interventions and therapies; including clinical and non-clinical trials and innovations
  • human genetics
  • human stem cells
  • women who are pregnant and the human fetus
  • children and young people (with some exceptions)
  • people highly dependent on medical care who may be unable to give consent
  • people with a cognitive impairment, an intellectual disability, or a mental illness 
  • people who may be involved in illegal activities
  • Aboriginal and Torres Strait Islander peoples
  • people in other countries (with some exceptions)

Lower risk research will be reviewed by a Lower Risk Human Research Ethics Committee (LRHREC). There are three LRHRECs that convene and review lower risk research projects for each Faculty:

• Faculty of Arts, Business, Law and Economics Lower Risk Human Research Ethics Committee (ABLE LRHREC);
• Faculty of Health and Medical Sciences Lower Risk Human Research Ethics Committee (HMS LRHREC); and
• Faculty of Science, Engineering and Technology Lower Risk Human Research Ethics Committee (SET LRHREC).

Applications for lower risk review must be submitted to the HREC according to its annual schedule of meeting deadlines.

Research timetables should allow for the possibility that a project submitted as a lower risk application may be deemed to involve more than low risk, or to raise other issues, therefore requiring full review. Researchers may be requested to provide additional information.

Research that requires full review, is research which satisfies any of the following conditions:

• it involves
  • the use without consent of personal information in medical research, or personal health information
  • interventions and therapies; including clinical and non-clinical trials and innovations
  • human genetics
  • human stem cells
  • women who are pregnant and the human fetus
  • children and young people (with some exceptions)
  • people highly dependent on medical care who may be unable to give consent
  • people with a cognitive impairment, an intellectual disability, or a mental illness
  • people who may be involved in illegal activities
  • Aboriginal and Torres Strait Islander peoples
  • people in other countries (with some exceptions)
• the level of risk to participants and others is more serious than discomfort i.e. harm. Harm includes physical, psychological, devaluation of personal worth, social, economic and legal harm
• it involves concealment or deception of any kind. Research where the true purpose, or the collection of data itself, is concealed or where participants are deceived, is not considered ethical unless compelling reasons are given for its use.

Applications for full review must be submitted to the HREC according to its annual schedule of meeting deadlines.

There is one application form covering both low-risk and full HREC review. An application for ethics approval must include the following documentation (see below for further information for each form):

• Application for ethics approval
• Participant Information Sheet (see below)
• Online Survey (see below)
• Drugs to be administered form

The HREC requires that all potential research participants must be provided with sufficient information to make an informed decision about participation. In most cases, this should be provided using the University's Participant Information Sheet template. The template should be modified to be relevant to the specific participants and the needs of the project; however, applicants that wish to use a different template will need to justify their approach.

Please note the following:

• The Participant Information Sheet is a means of clarifying information for participants to help them make informed decisions about their involvement in the research. It must not replace personal communication between the investigator and the potential participant, and does not in itself constitute to participate.
• The sheet must be translated if non-English speaking participants are to be recruited.
• Details in Participant Information Sheets should be tailored to the participant group and the nature of the research activity (e.g. age of participant, cultural sensitivities, English as a first language, etc). Please ensure the information is present in plain language and not complex or technical (year 8 reading level).
• Investigators should ensure that potential participants are given sufficient time to consider the verbal and written information provided, and to discuss it with other people, before being asked to give consent to involvement. 
• contact and independent complaints information is to be given to research participants. This can be via the Participant Information Sheet (see template for the standard paragraph). This information should provide participants with the appropriate contact details for seeking additional information on the project, for raising concern or for making a complaint. 
• Where research is being conducted overseas, it is recommended participants are provided with a local, 'independent' person as a contact for queries or complaints.
• Please refer to the complaints section of this site for further assistance.

Generally, written consent of participants to be part of a research project is required unless it can be justified in accordance with the National Statement on Ethical Conduct in Human Research 2023.

Approval for obtaining the oral consent of participants is given only in special circumstances and this will need to be justified in the ethics application.

In most cases, one of the University's three Consent Form templates should be used. Applicants that wish to use a different template will need to justify their approach. 

There are standard consent form templates depending on the nature of the research and/or the participants involved:

• Consent Form - for participants in a non health/medical research project
• Consent Form - for participants in a health/medical research project

• Consent Form - for University students

Where the research involves a person under 18 years, or a person with a cognitive impairment or a disability that may impact on their capacity to consent, or those in dependent relationships or comparable situations, it is also necessary to obtain the informed consent of the parent, legal guardian or authorised third party. There are two third party consent form templates:

• Consent Form - third party to participation in non health/medical research
• Consent Form - third party to participation in health/medical research

Please note that copies of the Participant Information Sheet and signed Consent Forms must always be provided to participants for their record.

Surveys should include a survey preamble that uses the same content within Participant Information Sheet template (as above) and the Consent Form template (as above). In the case of online surveys, this information should be embedded at the start of the survey with a checkbox or similar that participants can use to indicate consent (as they cannot physically sign the form).

The full survey with the preamble needs submission to the ethics committee with the same information that will be seeb by the participant.

Approved Survey Platforms:

• REDCap: Research Electronic Data Capture - REDCap | Information Technology and Digital Services | University of Adelaide
• Qualtrics: Qualtrics | Information Technology and Digital Services | University of Adelaide

All internal surveys conducted on University of Adelaide staff or students must be submitted to the University's Survey EQ via surveys@adelaide.edu.au to outline the purpose of the survey, target population and intended commencement date of the survey. The request can be submitted concurrently to the HREC submission.

For more information see: https://www.adelaide.edu.au/learning/quality-assurance/survey-approval#compliance

IP Addresses: Please ensure surveys are not collecting IP addresses as this is considered identifiable information and no longer makes your survey anonymous. If IP address is required to avoid duplication of surveys, that is ok as long as it's made clear in the application that participants are re-identifiable.

Contacts and independent complaints information is to be given to research participants. This can be through a paragraph in the participant information sheet (see template for the standard paragraph). This information should provide participants with the appropriate contact details for seeking additional information on the project, for raising a concern or for making a complaint.

Where research is being conducted overseas, it would be helpful to participants if a local, 'independent' person is also included as a contact for complaints.

Please refer to the complaints section of this site for further assistance.

• If the project is to be undertaken by a research student, the student's primary or other supervisor at the University of Adelaide is the 'applicant'.
• Applications must be signed by all investigators named.
• The application is to be submitted to the HREC Secretariat as one PDF file (editable, not scanned version of the signed application including all attachments) via email to hrec@adelaide.edu.au.
• All applications must reach the HREC Secretariat by the deadline date.
• Researchers may be asked to provide additional information during the application review process.

Ethics approval is granted for a period of five years subject to annual progress reporting. Applications for an extension of approval should be submitted prior to the expiry date of ethics approval to allow the HREC sufficient time to undertake the ethical review.

To extend existing ethics approval for another five year period, the researcher is required to complete:

• an annual report on project status: providing an update on the current status of the project and
• The HREC Application form template was updated in 2019 to reflect changes made to the National Statement in 2018. If your approved application uses a pre-2019 template, please submit your extension request using the current template, via copying information across and adding the amendment information (highlighted/tracked). Submit all approved and amended documents as one PDF.

Both forms should be saved separately as PDF documents and emailed to the HREC Secretariat at hrec@adelaide.edu.au.

Extension of ethics approval for HDR students

For projects involving higher degree students, current ethics approval needs to be maintained for the duration of candidature up until submission of their thesis/PhD. An extension of approval should be obtained when the research cannot be completed in the existing ethics approval period.

For students in the writing up stage of their higher degree and no further interactions with participants or data collection activities are planned, please submit only the completed annual report on project status to the HREC Secretariat who will advise if a new ethics application is also required.

Chairperson: Professor Chris Boyle

Submissions and enquiries to: hrec@adelaide.edu.au

                     Human Research Ethics Committee (HREC) application dates

*Please note that the feedback date provided is for reference purposes only and is subject to change in the event of staff shortages or any other disruptions to office operations. We appreciate your understanding and flexibility in such situations.

Chairperson: Professor Edward Palmer

Enquiries to: hrec@adelaide.edu.au

Submissions to: edward.palmer@adelaide.edu.au

               ABLE Lower Risk Human Research Ethics Committee application dates 2024

*Please note that the feedback date provided is for reference purposes only and is subject to change in the event of staff shortages or any other disruptions to office operations. We appreciate your understanding and flexibility in such situations. 

*Please note that the feedback date provided is for reference purposes only and is subject to change in the event of staff shortages or any other disruptions to office operations. We appreciate your understanding and flexibility in such situations. 

*Please note that the feedback date provided is for reference purposes only and is subject to change in the event of staff shortages or any other disruptions to office operations. We appreciate your understanding and flexibility in such situations. 

Chairperson: Professor Paul Delfabbro

Submissions and enquiries to: paul.delfabbro@adelaide.edu.au