Human research ethics FAQs

Ethics approval is required for research projects involving human research.

Human Research is conducted with or about people, their data, and/or their tissue. The term ‘participants’ is used very broadly to include those who may not even know they are the subjects of research. In Australia the National Statement is designed to clarify the responsibilities of institutions and researchers for the ethical design, conduct and dissemination of results of human research.

The National Statement on Ethical Conduct in Human Research 2007 (updated 2018) (National Statement), consists of a series of guidelines made in accordance with the National Health and Medical Research Council (NHMRC) Act 1992.

The National Statement is developed jointly by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC) and Universities Australia.

The purpose of the National Statement is to promote ethical human research. Fulfilment of this purpose requires that participants be accorded the respect and protection that is due to them. It also involves the fostering of research that is of benefit to the community.

To draft an ethics application, plan and allow time. Consider the relevant guidelines including TUA policies, legislation such as the Privacy Act 1988 and the National Statement.

At Torrens University Australia the Ethics Review Manager (EthicsRM) online system by Infonetica is in place to manage ethics applications for research projects that involve humans. EthicsRM utilises a licensed copy of the NHMRC's Human Research Ethics Application Form (HREA) for electronic submission of ethics applications. This online environment enables collaboration between researchers.

The ethics application is a licensed copy of the NHMRC's Human Research Ethics Application Form (HREA) for electronic submission of ethics applications within EthicsRM.

The HREA, developed by the NHMRC, is designed to facilitate ethics review for research involving humans, considering the National Statement.

• 'Project Description': The TUA Project Description template format.

• ‘Curriculum vitae’: CV documents for each team member.
• ‘Invitation to participant’: Recruitment documents, eg flyers, introductory emails.
• ‘Letter of support’: TUA management endorsement.
• ‘Participant information and consent (PICF): The TUA PICF template format.
• ‘Questionnaire’: All data collection instruments, eg survey questions, interview questions.

The ‘Participant Information and Consent Form is commonly known as the PICF. This is the primary guidance document for participants to enable informed consent, as directed by the National Statement. The Participant Information and Consent Form (PICF) document must be provided in the TUA approved template format.

This one document combines the ‘Participant Information Sheet’ and the ‘Consent Form’. The PICF is in place to provide participants with clear information regarding the research and risks, with a detailed overview of the commitment required.

Ethics application are reviewed by the TUA HREC. The HREC meet 6 times per year, bi-monthly. The schedule of dates and submission deadline dates can be found at MyTorrens Human Research Ethics.

It is good practice to plan your ethics application, allowing ample time for feedback from both the HRE Office and the HREC, as required.

When you first submit an ethics application in EthicsRM, the HRE Office will conduct a compliance review. This is to identify any gaps within the application and provide advice in line with the National Statement, to ensure the application is complete.

The application will be reverted to the researcher within EthicsRM to address the commentary raised by the HRE Office. This allows the HREC to consider your ethics application in entirety.

Refer to the ‘HRE Application Pathway'

If your project involves human research and requires ethics approval, you must receive final approval in writing prior to beginning any research activities.

The National Statement Ch 5.3 recommends that institutions adopt processes to eliminate the unnecessary duplication of ethical review.

An ethical approval issued by an external Australian HREC that is registered with the NHMRC, may be recognised by the TUA HREC. Recognition of an external HREC approval is dependent on the risk assessment and at the discretion of the HREC.

Please seek advice from the HRE Office at ethics@torrens.edu.au.

The following projects do not require human research ethics approval:

• Research that does not involve humans, their data, or their tissues/fluids
• Activities that are not for a research purpose including some quality assurance and evaluation activities.

Ethical approval by the TUA HREC is in a letter format, via email.

The approval is subject to the following conditions being met:

• The Principal Investigator will immediately report anything that might warrant review of ethical approval of the project.
• The Principal Investigator will notify the Human Research Ethics Office of any event that requires a amendment to the originally approved ethics application. An Ethics Amendment Request should be completed and any change must be approved prior to implementation.
• The Principal Investigator will notify the Human Research Ethics Office of any unexpected adverse or serious events that my impact participant welfare of the conduct of the project.
• The Principal Investigator will provide an annual progress/ final report to the Human Research Ethics Office for submission to the HREC and notify the HREC when the project is completed at all sites.
• The Principal Investigator will notify the Human Research Ethics Office if the project is discontinued at a participating site before the expected completion date, with reasons provided.
• The Principal Investigator will notify the Human Research Ethics Office of any plan to extend the duration of the project past the approval period listed above and will submit any associated required documentation. An Ethics Extension Request should be completed and any change to the approval period must be approved prior to implementation.
• The Principal Investigator will notify the Human Research Ethics Office of their inability to continue as Principal Investigator including the name of and contact information for a replacement.

Further, the research project cannot proceed at any site until separate research governance permission has been obtained from the appropriate authority.

The National Statement Section 4 provides guidance pertaining to specific issues that may arise in the design, conduct and review of identified categories of participants.

Research involving the following participant groups is considered by the National Statement to be more than low risk:

• Women who are pregnant and the human fetus (National Statement Ch 4.1)
• People highly dependent on medical care who may be unable to give consent (National Statement Ch 4.4)
• People with cognitive impairment, an intellectual disability, or a mental illness (National Statement Ch 4.5)
• People who may be involved in illegal activities (National Statement Ch 4.6)
• Aboriginal and Torres Strait Islander Peoples (Nationals Statement Ch 4.7)

For some research projects:

• People in other countries (National Statement Ch 4.8)

Research involving children require government mandated screening assessments.

The National Statement Chapter 4.2: Children and young people describes how to apply the principles of Justice, Beneficence and Respect when conducting research with children.

Additional guidance to consider can be found at the government website Children and young people participating in research - Australian Institute of Family Studies.

Working with children assessments are different in each state and territory of Australia:

• Australian Capital Territory
• New South Wales
• Northern Territory
• Queensland
• South Australia
• Tasmania
• Victoria
• Western Australia

Approval to conduct research in Australian education facilities such as government schools involves:

1. Approval from the Torrens University Australia HREC.
2. Approval from the relevant state government education agency.
3. Permission from individual school principals.

If you plan to conduct your research with students in government schools, you need permission beforehand, from both the relevant state government education agency and the individual school, usually through the principal.

There are various documents that each agency requires, which may include proof of public liability insurance. For each state, please refer to the following ‘Australian education agencies: Guidelines’.

Research with or in Australian private schools is directed by each organisation’s guidelines. For example Catholic Education.

To conduct research in or with public schools in Australia, different guidelines may apply to researchers undertaking projects across each state and territory.

Researchers should consult guidelines specific to the state or territory research is to be conducted in.

• Australian Capital Territory
• New South Wales
• Northern Territory
• Queensland
• South Australia
• Victoria
• Western Australia

Within Australia, research with or about Aboriginal is jurisdiction based, and each jurisdiction may or may not have a formal ethics committee.

For example, in South Australia (SA), the Aboriginal Health Council of SA Research Ethics Committee is ‘AHREC’, and this committee reviews research prior to presenting to the institutional HREC.

For national projects, depending on the research project, AIATSIS HREC may be an avenue to consider. However, this does not surpass the requirement for jurisdictional review or consultation. For example, research involving Aboriginal communities and conducting fieldwork in SA or NSW, require ethical review from the relevant jurisdictional HRECs such as AHREC (in SA), and AHMRC HREC (in NSW).

If there is no formal jurisdictional Aboriginal HREC, researchers should contact relevant stakeholders within that jurisdiction for advice and consultation.

In submitting an ethics application to the TUA HREC, researchers are expected to demonstrate how they have addressed Aboriginal inclusivity in the research project design, including participant recruitment and data collection. Researchers need to show how each phase of the research process is ethically defensible. Guidelines such as the AIATSIS Code of Ethics and the NHMRC guidelines relating to ethical research with Aboriginal and Torres Strait Islander peoples should be referred to.

If you plan to conduct research with current defence personnel or veterans, please refer to the Departments of Defence and Veterans’ Affairs Human Research Ethics Committee (DDVA HREC).

The National Statement on Ethical Conduct in Human Research defines a clinical trial as a form of human research designed to find out the effects of an intervention.

Clinical trials are required to register on a publicly available registry prior to enrolment of the first participant (for example, the Australian New Zealand Clinical Trials Registry).

Clinical drug trials notification forms can be accessed via the Therapeutic Goods Administration website.

To discuss clinical trials or insurance for clinical trials, contact RMS email.

When research involves an organisation, researchers must obtain written permission from an authorised individual within the organisation to recruit potential participants. The authorised individual must have delegation to authorise such recruitment activities for the purpose of research, within the organisation.

Permission from an organisation is a requirement of ethics approval and must be attached to the ethics application prior to approval being granted. Specific situations can be discussed with the HRE Officer at ethics@torrens.edu.au.

If research is planned within a hospital or local health network, ethics approval should be sought from the relevant HREC overseeing that hospital/network.

For example, the SA Government website provides an overview regarding health network and hospital HRECs.

Once ethics approval has been granted, the TUA HREC can provide reciprocal approval. An ethics application is required to be submitted within ERM, answering the questions accordingly regarding ‘has this application been approved by another HREC.

• The full ethics application submitted to the primary approving HREC
• The written approval document from the primary HREC
• All relevant attachments such as the PICF, data collection protocols etc.

As directed by the National Statement (Ch 5.3), the TUA HREC can provide reciprocal ethics application approval based on the approval of an Australian NHMRC registered HREC, in order to eliminate unnecessary duplication of ethical review.

If your research design includes the provision of a payment to participants, the payment should be in proportion to participant involvement, and must be clearly stated within the ethics application and the PICF.

For guidance, refer to both the National Statement and the additional NHMRC document: ‘Payment of participants in research: information for researchers, HRECs and other ethics review bodies 2019’.

The National Statement provides guidance at Chapter 2.2.10: “It is generally appropriate to reimburse the costs to participants of taking part in research, including costs such as travel, accommodation and parking. Sometimes participants may also be paid for time involved. However, payment that is disproportionate to the time involved, or any other inducement that is likely to encourage participants to take risks, is ethically unacceptable”.

Furthermore, “Researchers should provide assurance that any proposed payment in money or kind, whether to institutions, researchers or participants, will not adversely influence the design, conduct, findings or publication of the research” (National Statement 3.1.10).

Research projects that may uncover evidence of illegal activity, even if you are not directly studying the illegal activity. The possibility of disclosure of illegal information and the management of such information should be included within the ethics application for the HREC to consider.

This information should be included within the PICF to inform participants of the risks, and that if illegal activity is uncovered, there could be legal implications for you and for participants. You may have an obligation to share information uncovered, for example under mandatory reporting obligations or as required by law.

Chapter 4.6 of the National Statement provides specific information regarding research that may involve illegal activities.

Research outside of Australia is when the researcher is travelling to another country (not simply collecting data from an online survey internationally).

Overseas research might have legal, social or cultural implications and researchers are responsible for ensuring that research conducted overseas is culturally appropriate and complies with the legal requirements of that country, as well as complying with Australian ethical standards.

The National Statement requires that research conducted in other countries by Australian-based researchers should be conducted, as closely as possible, under the conditions set out in the National Statement and afford participants respect and protection accordingly. It is recognised that cultural sensitivities, legal, regulatory and non-Australian ethical review processes may produce tension with the National Statement requirements, and in these instances, researchers must address this tension and provide management mechanisms in the application. The researcher should be familiar with:

1. Whether the country that the research will be conducted in has a research ethics review framework.
2. The legal, professional and ethical standards of conducting research in that country. This can include issues such as requiring a special permit or visa to conduct research, and permission from the specific site (for example hospital or local health network authorisation).

The National Statement Ch 4.8 ‘People in other countries’ includes considerations when conducting research in another country.

“Local cultural values should be acknowledged in the design and conduct of the research. It should be clearly established that such acknowledgement will result in participants being accorded no less respect and protection than this National Statement requires.” (National Statement 4.8.2).

and

“Researchers should inform ethical review bodies in Australia":

1. whether, in the country in which they intend to do research, there are ethics approval processes that are relevant to that research, and whether any such processes are mandatory or voluntary in relation to the proposed research; and
2. how such processes function, the values and principles on which they rely, and whether they require reporting of the Australian review body’s approval.” (National Statement 4.8.4).

Researchers must be familiar with requirements relating to research permits and government permissions in the proposed country. It is the researcher’s responsibility to investigate and meet these requirements, providing written evidence with the ethics application.

General information is available at the International Compilation of Human Research Standards.

Please contact Research Management Services researchoffice@torrens.edu.au if you have any specific research insurance enquiries.

Failure to notify Research Management Services may result in the project being excluded from cover.

If your research involves external collaborators, it is the researcher's responsibility to ensure that, where required, an appropriate written agreement is in place. This should include (but not limited to) the submission and management of ethics applications, and the ownership of data and intellectual property.

Within the ethics application, you will be required to describe the research methods that you plan to use. The methods include, but are not limited to:

• Action research
• Biospecimen analysis research
• Data linkage research
• Ethnographic research
• Epidemiological research
• Interventional/ Clinical Trial research
• Observational research
• Survey/Interview/Focus Group research
• Textual analysis research

A description of the above research methods is provided within the ethics application HREA form online.

Within your ethics application, further to your stating the research methods, you will be required to provide details regarding the way you plan to collect and manage data. To assist with planning, researchers should consider the TUA Research Data Management Policy

To allow the HREC to consider your application, clearly describe how you will be collecting data at each phase of research, including attachments such as survey instruments, interview questions, focus group questions etc.

If you are transcribing the data, information regarding transcription is required, including whether the transcription is planned to be outsourced. If you are using an external transcription service, a confidentiality agreement is required.

All data collection and data management information should be clearly stated within the PICF to enable participants to make an informed decision (refer to National Statement 2.2.1).

The concept of ‘personal information’ is broad under the Australian Privacy Act 1988.

The Privacy Act 1988 (Privacy Act) defines personal information as

“… information or an opinion about an identified individual, or an individual who is reasonably identifiable:

1. whether the information or opinion is true or not; and
2. whether the information or opinion is recorded in a material form or not.” Office of the Australian Information Commissioner, Australian Government.

For example, personal information may include:

• an individual’s name, signature, address, phone number or date of birth
• sensitive information
• credit information
• employee record information
• photographs
• internet protocol (IP) addresses
• voice print and facial recognition biometrics (because they collect characteristics that make an individual’s voice or face unique)
• location information from a mobile device (because it can reveal user activity patterns and habits)

Office of the Australian Information Commissioner, Australian Government.

The Privacy Act 1988 (Privacy Act) defines sensitive information as

(a) information or an opinion about an individual’s:

1. racial or ethnic origin; or
2. political opinions; or
3. membership of a political association; or
4. religious beliefs or affiliations; or
5. philosophical beliefs; or
6. membership of a professional or trade association; or
7. membership of a trade union; or
8. sexual orientation or practices; or
9. criminal record; that is also personal information; or
10. health information about an individual; or
11. genetic information about an individual that is not otherwise health information; or
12. biometric information that is to be used for the purpose of automated biometric verification or biometric identification; or
13. biometric templates.

Privacy Act 1988 Part II Interpretation: Division 1 General definitions.

Torrens University Australia student/staff data that is collected by Torrens University Australia is not freely accessible to researchers for use within research projects.

Researchers that would like to use student/staff data as part of a research project, should consider student/staff as participants, and as such apply the same rigour to recruitment, information and consent.

As with all research participants, students/staff should be provided with a PICF and full disclosure regarding the research project and proposed data collection. Informed consent from each participant is required.

Further, researchers should consider the power balance that exists, which may reduce the voluntary nature of the student/staff decision to participate.

Refer to Torrens University Australia Human Research Ethics Procedure “8.2 Students as potential participants: Academic staff should note that access to student records for teaching purposes does not grant access for research purposes. Projects that wish to use student data from the student’s academic record for research purposes will require an ethics application”.

Refer to FAQ 4.1 below.

If you are planning to recruit Torrens University Australia students/staff as research project participants, researchers should consider the relevant guidelines within the National Statement and the TUA Human Research Ethics Procedure section 8.2.

The National Statement advises that participants should be accorded respect, with though and consideration given to the ‘over research’ of a cohort.

Power Imbalance - Coercion and Pressure

No person should be subject to coercion or pressure in deciding whether to participate. Even where there is no overt coercion or pressure, consent might reflect deference to the researcher’s perceived position of power, or to someone else’s wishes. Here as always, a person should be included as a participant only if his or her consent is voluntary [National Statement 2.2.9].

….pre-existing relationships between participants and researchers or between participants and others involved in facilitating or implementing the research. These relationships may compromise the voluntary character of participants’ decisions, as they typically involve unequal status, where one party has or has had a position of influence or authority over the other. Examples may include relationships between:….. teachers and their students;… [National Statement Ch 4.3]

Where the researcher has a pre-existing relationship with potential participants, it may be appropriate for their consent to be sought by an independent person. [National Statement Ch 4.3]

Data collected for another purpose other than research, that is not publicly available, may require participant consent and an ethics application.

Data can be accessed if the HREC can be confident that you can address the de-identification and privacy concerns, as well as due respect demonstrated to participants. Importantly, data that was not initially collected for the purpose of research, will be more closely scrutinised.

Data De-identification Considerations

The CSIRO provides a De-identification Decisions Making Framework

National Statement Ch 3.1 Elements of Research “In this increasingly complex environment, researchers are encouraged to consult guidance promulgated by expert bodies such as the Office of the Australian Information Commissioner and its state and territory equivalents, the Australian Bureau of Statistics and the Australian National Data Service in addition to this National Statement.

National Statement Ch 3.1.41 Researchers should adopt methods to reduce the risk of identification during collection, analysis and storage of data and information. Methods to reduce identifiability and the consequent risks may include:

(a) minimising the number of variables collected for each individual;
(b) separation and separate storage of identifiers and content information; and
(c) separating the roles of those responsible for management of identifiers and those responsible for analysing content.

Administrative data or information is data or information routinely collected during the delivery of a service e.g. by a government department or private service provider and may involve collections of data or information from large numbers of people or whole populations. It is usually impractical to obtain consent from individuals for secondary use of this data or information. In these circumstances, respect for participants can be demonstrated in other ways, including, but not limited to, community consultation, ensuring that the research results are translated into improvements in services and practices, acknowledging the source of the data or information in publications and/or publishing the research results in a location and language suitable for the general community. In particular, using data or information without consent may undermine public trust in the confidentiality of their information.

and

Privacy concerns arise when the proposed access to or use of the data or information does not match the expectations of the individuals from whom this data or information was obtained or to whom it relates. [National Statement Ch 3.1 ‘Secondary use of data or information’].

Research may involve the secondary use of data; information that was originally collected for another purpose (such as previous research or for non research purposes, including routinely collected data or information). In this circumstance consideration must still be given to privacy and informed consent.

The National Statement Ch 3.1 Element 4, includes guidance regarding secondary use of data.

“Privacy concerns arise when the proposed access to or use of the data or information does not match the expectations of the individuals from whom this data or information was obtained or to whom it relates. These issues are especially complex in the context of the access to or use of information relating to individuals that is available on the internet, including social media posts, tweets, self-generated ‘lifelogging’ data emitted from mobile phones and other ‘smart’ appliances and data or information generated through applications and devices related to personal pursuits, such as fitness activity, gambling, dating and web-based gaming.”

As stated in the National Statement, there are complexities in considering the secondary use of data, including accessing data available online. Although the data may be publicly available, this does not necessarily address the issue of consent and permission for its use in research.

Please seek advice from the HRE Office regarding your proposed research project if you are unsure about the data you are accessing.

The National Statement Ch 3.1 Element 4 instructs researchers to develop a data management plan to address their intentions relating to collection, access, use, analysis, disclosure, storage, retention, disposal, sharing and re-use of data.

For data management guidelines at TUA, please refer to the TUA Research Data Management Policy.

Evaluation activities are conducted regularly, often related to teaching and learning or staff/student experiences. Typically, this may include evaluation instruments used to gather feedback regarding courses, teaching or corporate environment.

Information that is collected for such purposes as to inform improvements/quality assurance at Torrens University Australia, is not accessible to utilise within research unless informed consent has been provided from the participant.

Refer to TUA Human Research Ethics Procedure “8.2 Students as potential participants: Academic staff should note that access to student records for teaching purposes does not grant access for research purposes. Projects that wish to use student data from the student’s academic record for research purposes will require an ethics application”.

Also, refer to ‘Secondary data’ in the FAQ listing and the National Statement Ch 3.1 Element 4.

For research that is undertaken for assessment purposes only, such as part of coursework, refer to the TUA Human Research Ethics Procedure sections 8.2 and 8.3.

If the intent of the research is a publication (academic journal, conference etc) and the research involves human participants, then an ethics application must be submitted and approval gained from the HREC prior to undertaking research activity. It is important to note that approval cannot be granted retrospectively by the HREC.

As the Torrens University Australia policy states, if the research is for learning and assessment purposes only, an ethical review may not be required. However, students conducting research for assessment should adhere to the concepts of beneficence, integrity, respect and privacy. The National Statement and Privacy Act 1988 are informative documents to guide on such concepts.