Human Research Ethics Applications
All human research must comply with the following NHMRC Guidelines & Statements:
- National Statement (NS) on Ethical Conduct in Human Research 2007 (updated 2018)
- Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: guidelines for researchers and stakeholders
- NHMRC guidelines under Section 95 and Section 95A of the Privacy Act 1988
University staff and students must be aware of and adhere to the following guidelines in the practice of their research:
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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- access to their information as part of an existing published or unpublished source or database.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.
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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
Research related to Aboriginal health and wellbeing
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.
- Visit the AHREC website for further guidance
- Contact the University’s HREC Secretariat to discuss your application
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:
- AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research
- AIATSIS Ethical Research
- AIATSIS Research
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.
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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:
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Research exempt from HREC review
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.
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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.
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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.
- it involves
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
- General enquiries: HREC Secretariat
- Ethical issues checklist for human research*
* 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 (Updated 2018) 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):
- Application for ethics approval
- Participant information sheet
- Online Survey:
- Consent Form(s):
- 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.
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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.
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.
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Consent forms
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
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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
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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.
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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.
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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.
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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:
- 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.
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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 -
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 -
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 -
Human Ethics Research Committee: HREC (Higher Risk) meeting dates
HREC meeting dates 2023 Submission deadlines (by 5.00pm)
HREC meeting dates
16 January 2023 6 February 2023 27 February 2023 20 March 2023 27 March 2023 17 April 2023 1 May 2023 22 May 2023 5 June 2023 26 June 2023 10 July 2023 31 July 2023 14 August 2023 4 September 2023 18 September 2023 9 October 2023 23 October 2023 13 November 2023 20 November 2023 11 December 2023 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
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
Contact us
Human Research Ethics team - Research Services
T: (08) 8313 6028 | E: hrec@adelaide.edu.au
Contact:
- Mel Kluge