Human Research Ethics Applications

All human research must comply with the following NHMRC Guidelines & Statements:

University staff and students must be aware of and adhere to the following guidelines in the practice of their research:

  • What is human research?

    Human research is research conducted with or about people, or their data or tissue. It can be broadly understood to include:

    • taking part in surveys, interviews or focus groups;
    • undergoing psychological, physiological or medical testing or treatment;
    • being observed by researchers;
    • having access to their person documents or other materials
    • the collection and use of participants' body organs, tissues, fluids or exhaled breath; and
    • access to their information as part of an existing published or unpublished source or database. 

    However, other research activity with humans as participants may come within the Human Research Ethics Committee's (HREC) area.

    Guidance on the definitions of 'research' and 'what is human research?' is contained in the National Statement on Ethical Conduct in Human Research 2007 (updated 2018) [pp. 6-8].

    Research investigations of doubtful status should be referred to the HREC for consideration.

  • Aboriginal & Torres Strait Islander peoples

    Proposals to conduct research involving Aboriginal and Torres Strait Islander peoples or communities need to be submitted to the University’s Human Research Ethics Committee.

    Applications

    If your research is directly related to the health and wellbeing of Aboriginal peoples, you will be required to submit an application to the Aboriginal Health Research Ethics Committee (AHREC). Depending on the nature of your project, you may also be required to submit health-related applications to both AHREC and the University’s HREC. All other applications for research involving Aboriginal and Torres Strait Islander Peoples must be submitted to the University HREC.

    Guidelines

    The following guidelines and statements are designed to ensure the ethical design and conduct of research involving Aboriginal and Torres Strait Islander Peoples.

    Australian Institute of Aboriginal and Torres Strait Islander Studies (AIATSIS)

    In October 2020 AIATSIS published the Code of Ethics for Aboriginal and Torres Strait Islander Research. This document supersedes and replaces the Guidelines for Ethical Research in Australian Indigenous Studies (GERAIS). All references to GERAIS in Australian research codes and guidance should be taken to refer to the latest AIATSIS Code. All researchers must ensure that they address the requirements of this Code. Please read the Code and further information about the guidelines, application framework, forms and templates, committee meeting dates and FAQs:

    National Health and Medical Research Council (NHMRC)

    The Australian Code for the Responsible Conduct of Research 2018 (the 2018 Code) establishes a framework for responsible research conduct that provides a foundation for high-quality research, credibility and community trust in the research endeavour:

    The National Statement on Ethical Conduct in Human Research 2007 (National Statement 2007) consists of a series of guidelines made in accordance with the National Health and Medical Research Council Act 1992:

    The below guidelines provide a set of principles to ensure research is safe, respectful, responsible, high quality and of benefit to Aboriginal and Torres Strait Islander people and communities:

    The below document is a companion guideline that provides advice on how these values and principles can be put into practice in research:

    Visit the NHMRC website for further information and resources.

    Willandra Lakes Region World Heritage Aboriginal Advisory Group Code of Practice

    The Willandra Lakes Region World Heritage Aboriginal Advisory Group has developed a Research Code of Practice. This Code of Practice outlines a new Ethical Research Framework for the Willandra and Mungo National Park and has been developed with over 40 years of intensive research in the region. It is based on the AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander research, and has been tailored specifically for use in the Willandra Lakes Region.

  • Research on self

    In general, experiments by a researcher on himself or herself will not be approved, as self-experimentation lacks meaningful informed consent in the manner required. However, where the proposed procedure is in no way dangerous or unreasonable, and where objectivity in the observation of results can be maintained, self-experimentation may be approved.

University staff, students enrolled in the University, and persons in any way associated with or sponsored by the University who are involved in a human research project must ensure that the project has undergone the appropriate level of ethical review before it can commence.

All levels of ethical review are undertaken by the University's Human Research Ethics Committee (HREC). Ethics approval is granted for a period of three years subject to annual progress reporting.

To request an extension of ethics approval researchers must provide the HREC Secretariat with the required documentation well prior to the expiry date to allow time for the request to be considered and to ensure there is no lapse in approval.

Determining the level of ethical review

There are 3 levels of ethical review which are determined according to the National Statement on Ethical Conduct in Human Research (2007) and the level of risk to the project's participants:

    • Research exempt from HREC review

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

    • Research eligible for lower risk review

      '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 requiring full review

      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.

      What is risk?

      A risk is a potential for harm, discomfort or inconvenience. It involves:

      • the likelihood that any harm (or discomfort or inconvenience) will occur; and
      • the severity of the harm (or discomfort or inconvenience), including its consequences.

      Guidance on different levels of risk, and the differences between 'inconvenience', 'discomfort' and risks that are 'more serious than discomfort' is contained in The National Statement. Researchers should be familiar with these definitions when considering the level of review required for the research project.

      Please note:

      • the HREC is not able to give retrospective ethics approval to projects which have already commenced.
      • all researchers proposing to conduct surveys with University staff, students or Alumni as participants must also comply with the University's Survey Framework.This approval process is independent of the HREC.

      The HREC will assess the project in accordance with the NHMRC National Statement on Ethical Conduct in Research Involving Humans 2023 and other associated guidelines and legislation, as well as University Policies.

      All applications must be accompanied by the documents with which it is intended to gain informed consent of participants, typically the Consent Form and the Participant Information Sheet or it will need to be rejected.

      All applications must reach the HREC Secretariat by the submission deadline if they are to be included on the Agenda for the subsequent HREC meeting.

      The HREC is not able to provide retrospective ethics approval to projects which have already commenced.

      For any research that involves a public hospital in Australia, the University of Adelaide HREC is unable to review the application (unless prior approval has been granted by the Hospital Research Office to accept a University of Adelaide HREC Review). Please review the National Mutual Acceptance Scheme, guidance document that lists all the Hospitals involved in the Scheme. If one of your study sites is listed in this Scheme, you will need to submit to their institutional HREC, and once approved, submit a Notification Form to our office.

      • Application form

        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):

        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.

      • Participant information sheets

        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.

        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.

      • Consent forms

      • Contacts & independent complaints information

        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.

      • Submission process

        • 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.
        • All applications must reach the HREC Secretariat by the deadline date.
        • Researchers may be asked to provide additional information during the application review process.
      • Amendments

        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.

      • Extension of ethics approval

        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.

      The University of Adelaide has three newly formed Lower Risk Human Research Ethics Committees, meaning the University now has four ethics committees each as follows:

      • University of Adelaide Human Research Ethics Committee (Higher Risk HREC),
      • 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).

      Each committee has set meeting dates. Please be aware of these dates when submitting your applications and plan accordingly.

      • Lower Risk Human Research Ethics Committees: ABLE LRHREC meeting dates

                       ABLE Lower Risk Human Research Ethics Committee application dates 2024

        Submission Date Meeting Date Feedback Date*
        Thursday 04 January 2024 Thursday 25 January 2024 Tuesday 06 February 2024
        Thursday 08 February 2024 Thursday 29 February 2024 Tuesday 12 March 2024
        Thursday 14 March 2024 Thursday 04 April 2024 Monday 15 April 2024
        Thursday 18 April 2024 Thursday 09 May 2024 Monday 20 May 2024
        Thursday 16 May 2024 Thursday 06 June 2024 Tuesday 18 June 2024
        Thursday 13 June 2024 Thursday 04 July 2024 Monday 15 July 2024
        Thursday 11 July 2024 Thursday 01 August 2024 Monday 12 August 2024
        Thursday 15 August 2024 Thursday 05 September 2024 Monday 16 September 2024
        Thursday 19 September 2024 Thursday 10 October 2024 Monday 21 October 2024
        Thursday 24 October 2024 Thursday 14 November 2024 Monday 25 November 2024
        Thursday 21 November 2024 Thursday 12 December 2024 Monday 23 December 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. 

      • Lower Risk Human Research Ethics Committees: HMS LRHREC meeting dates

                        HMS Lower Risk Human Research Ethics Committee application dates 2024

        Submission Date Meeting Date Feedback Date*
        Thursday 11 January 2024 Thursday 01 February 2024 Monday 12 February 2024
        Thursday 22 February 2024 Thursday 14 March 2024 Monday 25 March 2024
        Wednesday 27 March 2024 Thursday 18 April 2024 Tuesday 30 April 2024
        Wednesday 24 April 2024 Thursday 16 May 2024 Monday 27 May 2024
        Thursday 23 May 2024 Thursday 13 June 2024 Monday 24 June 2024
        Thursday 27 June 2024 Thursday 18 July 2024 Monday 29 July 2024
        Thursday 25 July 2024 Thursday 15 August 2024 Monday 26 August 2024
        Thursday 29 August 2024 Thursday 19 September 2024 Monday 30 September 2024
        Thursday 03 October 2024 Thursday 24 October 2024 Monday 4 November 2024
        Thursday 07 November 2024 Thursday 28 November 2024 Monday 9 December 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. 

      • Lower Risk Human Research Ethics Committees: SET LRHREC meeting dates

                       SET Lower Risk Human Research Ethics Committee application dates 2024

        Submission Date Meeting Date Feedback Date*
        Monday 15 January 2024 Monday 05 February 2024 Wednesday 14 February 2024
        Monday 26 February 2024 Monday 18 March 2024 Wednesday 27 March 2024
        Thursday 21 March 2024 Monday 15 April 2024 Wednesday 24 April 2024
        Monday 29 April 2024 Monday 20 May 2024 Wednesday 29 May 2024
        Friday 31 May 2024 Monday 24 June 2024 Wednesday 03 July 2024
        Monday 08 July 2024 Monday 29 July 2024 Wednesday 07 August 2024
        Monday 12 August 2024 Monday 02 September 2024 Wednesday 11 September 2024
        Friday 20 September 2024 Monday 14 October 2024 Wednesday 23 October 2024
        Monday 21 October 2024 Monday 11 November 2024 Wednesday 20 November 2024
        Monday 25 November 2024 Monday 16 December 2024 Tuesday 24 December 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. 

      • Human Ethics Research Committee: HREC (Higher Risk) meeting dates

                          Human Research Ethics Committee (HREC) application dates

        Submission Date Meeting Date Feedback Date*
        Monday 08 January 2024 Monday 29 January 2024 Thursday 08 February 2024
        Monday 12 February 2024 Monday 04 March 2024 Thursday 14 March 2024
        Friday 15 March 2024 Monday 08 April 2024 Thursday 18 April 2024
        Monday 22 April 2024 Monday 13 May 2024 Thursday 23 May 2024
        Friday 24 May 2024 Monday 17 June 2024 Thursday 27 June 2024
        Monday 01 July 2024 Monday 22 July 2024 Thursday 01 August 2024
        Monday 05 August 2024 Monday 26 August 2024 Thursday 05 September 2024
        Monday 09 September 2024 Monday 30 September 2024 Thursday 10 October 2024
        Monday 14 October 2024 Monday 04 November 2024 Thursday 14 November 2024
        Monday 18 November 2024 Monday 09 December 2024 Thursday 19 December 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.

      All participants involved in research should be provided with contacts details of a person to receive complaints (National Statement: Chapter 5.7).

      The preferred way for researchers to do this is through a participant information sheet.

      Participants, researchers or other concerned individuals may wish to raise concerns or complaints about:

      • a University of Adelaide study
      • their rights as a participant
      • the conduct of a University of Adelaide researcher
      • a decision of the University of Adelaide Human Research Ethics Committee.

      Concerns or complaints raised will be treated in confidence and fully investigated in accordance with the University’s Responsible Conduct of Research Policy.

      Individuals who raise a concern or complaint will be informed of the outcome.

        Contact us

        Human Research Ethics team - Research Services

        T: (08) 8313 6028 | E: hrec@adelaide.edu.au

        Contact:

        • Mel Kluge