Human Research Ethics Applications

Research that satisfies all of the following conditions may be exempt from ethical review:

• It is ‘negligible risk’ research if: there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Research that uses qualitative methods e.g. face-to-face interactions between participant and researcher; personal interviews; focus groups; oral histories; observation; and on-line research that identifies participants, carries more than negligible risk and therefore requires HREC review (NS 3.1); and
• It involves the use of existing collections of data or records that contain only non-identifiable data about human beings. Existing data eligible for exemption refers to data that has been previously published or is publicly available prior to the time the researcher begins utilising the data for their research; and​​​​​​​
• The original data collection and the proposed use of the data must be consistent with the ethical principles outlined in the National Statement, and researchers must be able to confirm that conditions of consent were appropriate and that the original consent covers the proposed research; and​​​​​​​
• Permission from the data custodian is obtained prior to accessing the data and any conditions of access are observed.

Research is ‘negligible risk’ where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk.

Research that has undergone a thorough NS review by the researchers and meets the above conditions, is exempt from HREC review.

Researchers are to keep an auditable record of any research that is exempt from HREC review. To do this, complete the ethical issues checklist for human research and sign the Declaration.

'Low 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)

Low risk research may be reviewed by a review group or sub-committee of the HREC or executively approved by the HREC Convenor. The HREC has established review groups to deal with low risk research projects for the Faculties of Arts and the Professions (Arts/Profs) and the Faculty of Health and Medical Sciences.

Applications for low risk review may be submitted to the HREC Secretariat at any time.

Research timetables should allow for the possibility that a project submitted as a low 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
• Online survey preamble
• Consent Form(s):
  • Participants in a non health/medical research project
  • Participants in a health/medical research project
  • University students
  • Third party to participation in non health/medical research
  • Third party to participation in health/medical research
• Contacts & independent complaints
• Drugs to be administered form

Multi-institutional research

If your research is multi-institutional, the University of Adelaide Human Research Ethics Committee accepts ethics applications on the human research ethics application (HREA). The HREA is a web-based form that has been developed by the National Health and Medical Research Council to enable researchers from all disciplines to complete and submit an ethics application.

The HREA is available for completion at https://hrea.gov.au.

If using the HREA, it should be submitted along with any attachments as one PDF to hrec@adelaide.edu.au. You may be asked to provide information in addition to the HREA.

Please Note: in some instances, ethics approval from another HREC may be accepted by the University of Adelaide and a separate ethics application and approval is not required. Researchers should view the notification of existing approvals process before commencement of their research to determine if this ethics approval can be accepted.

The HREC requires information to be given to all potential research participants to assist them with their decision to take part. The preferred way to do this is through a participant information sheet template using the University's template.

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.

The sheet must be translated if non-English speaking participants are to be recruited.

Information in participant information sheets should be tailored to the participant group and the nature of the research activity.

When conducting surveys, the survey preamble should cover the content of a participant information sheet and outline that completion and submission of the survey indicates consent to being involved in the research project. For online surveys, this information should be embedded at the start of the survey, and may utilise the Online survey preamble template.

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.

The following items will usually be included:

• the University of Adelaide logo or departmental letterhead
• the title of the project
• the ethics approval number  
• a clear plain language statement explaining the purpose of the study
• a clear plain language statement explaining what will be asked of the participant, what will be involved and the time it will take
• the possible benefits from the study, to the participant and/or the community, indicating that these benefits are by no means assured
• all procedures that involve the participant, including the use of drugs or radioisotopes
• foreseeable risks, side effects, discomforts, inconveniences and restrictions, both immediate and later that will be involved, e.g. travel, absence from work
• if applicable an explanation that randomisation and/or placebos may be used
• a statement about how information collected will be used and results reported and publicised
• a statement about how the information and project records will be confidentially stored, who will have access to them and how long they will be kept
• a statement that the participant may withdraw from the study at any time
• assurances of confidentiality, if applicable to the project
• measures that will be taken in the event of an adverse event
• the name, title, email address, and telephone number of all members of the research group 
• a statement outlining the University's contacts and independent complaints procedure information (as per the Participant Information Sheet template).

The information sheet, consent form and independent contacts and complaints procedure information are to be given to the participant. The information sheet is to remain the property of the participant and a copy of the signed consent form should also be provided on request.

Use of the participant information sheet template is recommended.  The template should be modified to be relevant to potential participants and to suit the nature of the project.

A writing guide has been developed to assist researchers with writing participant information sheets. The writing centre is also available to help students to write participant information sheets.

Generally, written consent of participants to be part of a research project is required. 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 research where the only participant activity is completing a written or online survey, a separate consent form is not necessary. The survey preamble should cover minimum requirements of a participant information sheet as described approve, and outline to participants that completion and submission of the survey indicates their consent to be involved in the research project.

Consent forms should contain the following minimum requirements:

• the University of Adelaide logo or departmental letterhead
• the title of the research project.
• reference to the Information sheet and ethics approval number
• a statement about the confidentiality of participants' information.
• statement that makes it clear that the participant is free to withdraw consent at any time (there may be limitations in certain types of research).
• provision for a witness to sign (if participants will be asked to return form via email, post or fax the witness section may be deleted).
• a statement, signed by the person explaining the research, that the participant has been informed of and understands the proposed research. The person explaining the research must be of an appropriate status, and that status must be described on the consent form.

Consent form templates should be modified to suit the nature of the project and the participant activities.

At all times, the participant should be given a copy of the signed consent form and a copy of the information sheet.

There are three 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

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 version of the signed application (including all attachments) via email to hrec@adelaide.edu.au.
• Applicants are not required to submit paper copies of their application.
• Applications for full review must reach the HREC Secretariat by the deadline date.
• Researchers may be asked to provide additional information during the application review process.

It is a condition of approval that researchers report anything which might warrant review of ethical approval including proposed changes to the application.

Prior to proceeding with any changes, researchers must apply to the HREC for approval to amend the approved application. To request an amendment, researchers should submit their original ethics application with the amendments requested indicated with colour highlighting or track changes. 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 amendment 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.

A justification for the proposed amendments should also be included. Researchers should also ensure any annual reports on project status have been submitted according to the HREC's reporting requirements.

Amendment requests are to be sent to the HREC Secretariat at hrec@adelaide.edu.au.

Ethics approval is granted for a period of three 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 three 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.

Low risk applications may be reviewed by a sub-committee of the HREC or executively approved by the HREC Convener and can be submitted to the HREC Secretariat at any time.

Researchers in the School of Psychology should consult with the convener of the School of Psychology HREC Subcommittee regarding the application process.

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