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:

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:

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    • Research exempt from HREC review

      Research that satisfies both of the following conditions is exempt from ethical review:

      • It is ‘negligible risk’ research: there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience; and
      • It involves the use of existing collections of data or records that contain only non-identifiable data about human beings.

      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.

    • Research eligible for low risk review

      '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 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.

      Further information

      * This checklist is a general guide only and does not replace the need for researchers to do their own thorough review against the NS. The checklist has been created to assist researchers to meet their requirement for keeping an auditable record of any research undertaken that is exempt from HREC review.

      The HREC will assess the project in accordance with the NHMRC National Statement on Ethical Conduct in Research Involving Humans (2007) and in accordance with its own guidelines.

      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.

      Applications can be submitted at any time. Applications for full review must reach the HREC Secretariat by the submission deadline if they are to be included on the Agenda for the subsequent HREC meeting.

      To prevent processing delays, applicants are advised to ensure the application is submitted using the latest version of the form and templates available for download from this site.

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

      Ethics approval is granted for a period of three years subject to annual progress reporting using the annual report on project status form.

      To request an extension of ethics approval researchers must provide the HREC Secretariat with the required documentation prior to the expiry date of ethics approval.

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      • 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.

        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.
        • 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.
      • 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. If changes are being requested to other project documents e.g. the participant information sheet, include this with the amended application.

        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 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:

        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.

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      • Low-risk review: submit at any time

        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.

      • Full review: HREC meeting dates 2019

        Seven meetings of the Committee are proposed during 2019 on the following Mondays.

        Submission deadlines
        (due Tuesday 5.00pm)
        HREC meeting dates
        22 January  11 February
        5 March 25 March
        30 April 20 May
        18 June 8 July
        6 August 26 August
        24 September 14 October
        12 November 2 December
      • Full Review: HREC meeting dates 2020

        Eight meetings of the Committee are proposed during 2020 on the following Mondays.

        Submission deadlines
        (due Tuesday 5.00pm)

        HREC meeting dates

        14 January 3 February
        25 February 16 March
        7 April 27 April
        26 May 15 June
        30 June 20 July
        11 August 31 August
        22 September 12 October
        10 November 30 November

         

      All participants involved in research should be provided with contacts details of a person to receive complaints (National Statement 2.2.6).

      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.

      Complaints contact

      • Human Research Ethics Secretariat
        c/- Research Services
        The University of Adelaide SA 5005
        AUSTRALIA
        E: hrec@adelaide.edu.au
        P: +61 8 8313 6028