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Human ethics

Ethical guidance

The style and content of the information provided in the consent process needs to be suitable for the target group in terms of comprehension and literacy levels and cultural norms. Whatever process is chosen, the core information needs to be presented in a way that can be understood by the person being recruited.

The means of recording consent should also be appropriate to the participant group and the nature of the information being collected. Generally, you avoid collecting identifiable information if it is not necessary. This means consent may be:

  • Tacit e.g. for anonymous surveys. In this case you would state clearly in the information provided that return of the survey is taken as indicating consent; or
  • Verbal, if written consent is not meaningful (e.g. due to literacy) or inappropriate – just make sure you have a record of obtaining this consent (e.g. audio recording or diary note); or
  • Written; or
  • A combination of the above. A project may have multiple consent processes reflecting different stages of the project and/or different participant groups.

Examples of appropriate Participant Information Sheet and Consent Form documents are available below, along with checklist guides for what to include in these documents, however no ‘template’ exists – they are different for every study. To access any UOW Human Research Ethics templates (e.g. Application Form templates) please see our Forms, guidelines and policies page.

 

UOW resources for preparing Participant Information Sheets and Consent Forms

Please note that whilst these documents download in pdf form, you can "Save As" a Word document with Adobe and use as a template.

UOW examples of Participant Information Sheets

UOW examples of Consent Forms

Other sources of examples of consent documentation include:

Chapter 4.2 of the National Statement on Ethical Conduct in Human Research deals with research involving children and young people in detail. The HREC is looking for the ethics application to demonstrate understanding of this, in particular that consent processes ensure that participants who are children understand what is being asked of them, and that they can choose not to participate, to the extent that their stage of development allows. If there are expected to be barriers to comprehension (e.g. due to language) the process must also be designed to address this.

Consent processes usually involve a combination of written and verbal elements, depending on the project.

For very young children best practice is to provide a simple explanation of the activity, and obtain verbal assent. Formal written consent is obtained from the parent/carer.

For upper primary aged children, age appropriate information documents should be provided and the consent process designed to encourage adults (usually the parent/carer) to discuss the research with the child before consent is obtained. Parent/carer and child sign off are commonly included on the same form. For useful guidance, see the handbook on Understanding Consent in Research Involving Children.

Adolescents, particularly where over 14, should complete an autonomous consent process. Parents/carers should be informed of the research and in most cases parent/guardian consent should also be sought. There are some circumstances where a case can be made for relying solely on the consent of the young person (see National Statement 4.2.8 – 4.2.9). 

For a detailed discussion of the legal considerations see Laws relating to the giving of consent for persons with impaired capacity to provide informed consent to participate in research in each Australian State and Territory, 2017.

Most research involving Aboriginal and Torres Strait Islander peoples requires obtaining support from appropriate community representatives, and the process for engaging with the community and developing and managing the research project must respect cultural protocols.  There are three key guidelines for Indigenous research in Australia. 

Ethics applications for research that relates to the health and wellbeing of Aboriginal peoples and communities in NSW should be submitted to the Aboriginal Health and Medical Research Council (AH&MRC) HREC.  If you are unsure as to whether your research falls into this category, please consult the information on the AH&MRC website.

As the AH&MRC HREC is registered with the NHMRC, UOW researchers who receive HREC approval from the AH&MRC are required only to submit an application for ‘Acceptance of External HREC Approval’ to the UOW HREC, and are not required to submit a new application to the UOW HREC for review.

Consideration should always be given to whether there is a local HREC that would have more relevant knowledge of the cultural protocols of the community involved in the research than the UOW HREC.  Where this is the case, the application should be submitted to that HREC and an application for ‘Acceptance of External HREC Approval’ submitted to the UOW HREC.

If your research involves NSW Health and also requires approval by the AH&MRC, please contact the Ethics Office of the Local Health District involved in your research to check whether their HREC is also required to conduct a full review.

Please refer to the current UOW Research Integrity guidance regarding the use of GenAI in research.

Participants can be harmed by breaches of their privacy.  Human Research Ethics Committees must consider the potential for this, and whether research proposals comply with national and state legislation regarding the handling of personal information. Any data which allows identification of an individual is 'personal information'.

The underlying principle in all of the legislation is that personal information should not be used for a purpose other than the one for which the data was collected without consent.  The exceptions to this relating to research are:

  • When information is already in the public domain, with the exception of social media data, as per the information below.
  • In some cases identifiers may be removed by the data custodian and the data provided to a researcher. This generally requires approval by an HREC.
  • When an HREC has approved a request for a waiver of the privacy legislation. Strict criteria apply to granting a waiver. All four criteria must be met.

Criteria 1: The use or disclosure is reasonably necessary for research, or the compilation or analysis of statistics, in the public interest.

Criteria 2: You have taken reasonable steps to de-identify the information, or the purpose of the research cannot be served by using or disclosing de-identified information and it is impracticable to seek the consent of the person to the use or disclosure.

Criteria 3: If the information could reasonably be expected to identify individuals, the information is not published in a generally available publication.

Criteria 4: The use or disclosure of the health information is in accordance with the statutory guidelines on research.

Links

 NSW State Government Legislation and Guidelines

There are two key pieces of privacy legislation specific to the use of personal information in NSW. Details can be found on the NSW Information and Privacy Commission website. The key legislation is:

  • Privacy and Personal Information Protection Act 1998(NSW): The PPIP Act deals with how NSW public sector agencies manage personal information. Personal information refers to any information that relates to an identifiable person. For an overview of who is bound by PPIP and what it involves.
  • Health Records and Information Privacy Act 2002(NSW): The HRIP Act governs the collection, storage, use and disclosure of health information in both the public and private sectors in NSW.
  • This includes hospitals whether public or private, doctors and other health care organisations. It also includes other organisations that have any type of health information. This can be as varied as a university that undertakes research or a gymnasium that records information about a person's health and injuries.For an overview of who is bound by HRIP and what it involves.

Researchers wishing to access health and medical records should consult the Statutory Guidelines on the use or disclosure of Health Information for Research Purposes

ANONYMITY AND CONFIDENTIALITY – WHAT’S THE DIFFERENCE?

It is important for researchers to understand the difference between anonymity, confidentiality and privacy as each term is distinct and has practical implications for the way in which participant data is collected, used and managed.

Participant consent is based on the information provided to them, most commonly via a written participant information sheet (PIS).  If the information provided to participants explains that their data will, for example, be anonymous, when in fact the data is identifiable but confidential to the research team, researchers are likely to be in breach of their privacy obligations to participants and, as a result, their ethics approval.

Please see the key terms below to ensure that the information provided to your participants is accurate.

KEY TERMS

Privacy: a concept that relates to an individual’s control over information about them.

Anonymous data: data that can in no way be linked back to an individual participant.  Data collected in interviews, yarns and focus groups can never be anonymous.

Confidential data: data that will only be identifiable to the research team.

Personal information: information or an opinion about an identified individual, or an individual who is reasonably identifiable.  All reasonably identifiable information is considered personal information, and is governed by Australian and NSW Privacy Laws: The Privacy Act 1988; Privacy and Personal Information Protection Act 1998; Health Records and Information Privacy Act 2002.

Direct identifiers: identifiers that are unique to an individual.  Examples include names, medical reference numbers, email addresses etc.

Indirect identifiers: variables that enable information to be connected until an individual can be identified.  Whether data is indirectly identifiable depends on the context of the data collection (e.g. collecting demographic data from a relatively small sample size is likely to identify individual participants).  Examples include demographic data such as date of birth, gender, postcode etc. 

De-identified data: data that is no longer reasonably identifiable to an individual person.  De-identification of data must be considered in context – it requires more than just removing direct identifiers, it is about ensuring that data is not reasonably identifiable in a given context.

A word diagram showing the overlap of confidentiality, privacy and anonymity for research purposes The above diagram shows three circles overlapping to represent the overlap of confidentiality, privacy and anonymity for research purposes. From left to right, the first circle is royal blue and represents confidentially: only the research team knows the identity of the participants; the middle circle is dark blue and shows privacy: an individual's control over information about them; and the last circle displays anonymity: identity of participants is not known to the research team and cannot be deduced in any way.

Many online survey platforms (including Qualtrics) are set up to automatically collect participant IP addresses, which are then stored alongside each survey response.  As IP addresses are unique identifiers and have the potential to identify responses, it is important to ensure that IP addresses are not collected when using online survey platforms.  This is essential when participants have consented on the basis that the survey is anonymous.

When conducting anonymous surveys online, please select the appropriate security options to turn off the collection of IP addresses; the relevant information for Qualtrics can be found on the Qualtrics website, under ‘Anonymize Responses’.

The UOW Ethics Office is aware that IP addresses have historically been used to filter bot responses, or to remove duplicate human responses.  As noted above, to collect an IP address is to collect reasonably identifiable information, and IP addresses should not be used as a default for bot detection.  Qualtrics has published various fraud detection methods that can be applied for these purposes.

The ‘publicly available information’ exemption

Historically, it has been understood that when information, including identifying information, is already in the public domain, human ethics approval is not required for its use in research.  Some examples include:

However, the rise of social media and the creation of diverse online spaces – some of which are potentially accessible to anyone – has changed this discussion.  While many social media posts/comments are in the public domain, they are not necessarily viewed as such for those who authored them.  As many online spaces are highly private in nature, users may not reasonably expect to be observed or have their data collected for research purposes.  As explained in the National Statement on Ethical Conduct in Human Research:

“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… Data or information available on the internet can range from information that is fully in the public domain (such as books, newspapers and journal articles), to information that is public, but where individuals who have made it public may consider it to be private, to information that is fully private in character. The guiding principle for researchers is that, although data or information may be publicly available, this does not automatically mean that the individuals with whom this data or information is associated have necessarily granted permission for its use in research.” (Chapter 3.1, p 36)

For these reasons, human ethics approval is required to use data collected via social media for research purposes.

Social media spaces exist on a spectrum of publicness

A useful first step in considering these studies is to ask how public is the data?  Is it so public (e.g. a Tweet from the Prime Minister) that it could reasonably be considered public information, and therefore not be subject to the ethical requirements applied to the use of social media data?  Please note that the vast majority of social data proposed for use in research does not fall into this category.

For all other social media data proposed for use in research, the first step is to ensure that the data collection is lawful.

Legal requirements 

It is important to understand the definition of ‘personal information’ when proposing to use social media data in research.  NSW Privacy and Personal Information Protection Act 1998 defines personal information as ‘Information or an opinion…about an individual whose identity is apparent or can reasonably be ascertained from the information or opinion.’

In a research context, this means that just because someone’s name is not directly attached to the data collected about them, does not mean that the data is ‘de-identified’.  Often, data without direct identifiers attached (e.g. names) is still reasonably identifiable, meaning it is still someone’s personal information.  In the context of social media research, quotes are generally considered to be identifiable information. 

What does this mean for researchers proposing to collect reasonably identifiable data from social media?

In this situation, researchers have three options to work through:

  1. Restructure the research methodology to collect only de-identified information. Both NSW and National Privacy laws state that a person’s personal information can only be collected when ‘the collection of the information is reasonably necessary’ for a given purpose.  In a research context, this means that if the research aims can be achieved by collecting and using de-identified information, then that approach must be taken.  However, if the research aims cannot be met by using de-identified data, researchers should;
  2. Obtain consent from that person to use their data for research purposes. If obtaining consent is not practicable, researchers can;
  3. Apply for a waiver of consent. Researchers are able to apply for a waiver of consent from the HREC when they wish to use an individual’s personal information for research purposes without obtaining consent to do so. 

In the instance that a waiver of consent is requested from the HREC, the research team must address each point below from section 2.3.10 of National Statement: 

(a) Involvement in the research carries no more than low risk to participants.

(b) The benefits from the research justify any risks of harm associated with not seeking consent.

(c) It is impracticable to obtain consent (for example, due to the quantity, age or accessibility of records).

(d) There is no known or likely reason for thinking that participants would not have consented if they had been asked.

When responding to this point, researchers should consider the reasonable expectations of participants in this context.  For example, how public is this information?  What are the terms of use of the particular social media site being used?  What is the nature of the space they are posting in?

(e) There is sufficient protection of their privacy.

When responding to this point, researchers should consider whether, by collecting this data, they are placing participants’ privacy at a greater risk than they it currently stands.  Will the researchers publish data in a more public forum than it is currently available?

(f) There is an adequate plan to protect the confidentiality of data.

(g) In case the results have significance for the participants’ welfare there is, where practicable, a plan for making information arising from the research available to them.

(h) The possibility of commercial exploitation of derivatives of the data or tissue will not deprive the participants of any financial benefits to which they would be entitled.

(j) The waiver is not prohibited by State, federal, or international law.

Ethical Considerations

It is important to note that meeting legal requirements does not mean that data collection is ethical.  Whether proposing to collect reasonably identifiable information or completely de-identified information from social media, all researchers are required to address the following ethical considerations by completing the Research Using Social Media Data form (DOCX: 26 KB). This form should be submitted to the HREC with your Application Form.

What information will be collected? Names? Quotes? Key words? Please be as specific as possible here to support the committee’s understanding of how identifiable the data is.

Will consent be obtained from users? If not, why?

What are the reasonable expectations of social media users in this context?

(1) How public is the information?

      • From which social media site is data being collected? What are the terms of use of this site?
      • Is it in a closed group? A public facing comment on Facebook?  Or a more public site, like Twitter?
      • If from a closed group, how large is the group? Will group administrators (if any) consent?  Will group members be told of the researcher’s presence?  Will they consent?

(2) What is the nature of the space from which data will be collected?

      • This is an important consideration in determining the ethical acceptability of the data collection and relates primarily to respect for participants’ privacy.
      • Many online spaces are highly private/sensitive in nature and exist as a social support for a particular group of people. It is important to consider the invasiveness of the researcher’s presence – even when no identifiable information is to be collected.  As the level of intrusiveness grows, so do the risks to privacy.
      • Researchers should keep in mind that the likely benefit of the research must justify the risks to participants (see National Statement 1.6 on Beneficence). This means that as the risks to privacy rise, so too must the likely benefit of the research. 

The ethics of using social media data in research is a fast-changing space and it is important that researchers re-consult with this guidance through time.

Although researchers in NSW are not considered to be “mandatory reporters” of child abuse and neglect, Section 24 of the Children and Young Persons (Care and Protection) Act 1998 provides for any person to make a report if they suspect on reasonable grounds that a child is at significant risk of harm, such as:

  • Information from your own observations of the child’s physical condition or behaviour, something that the child might tell you, or information gained from any other person
  • You must be able to recognise and understand the abuse and neglect.

The extent of harm to a child’s safety, welfare and wellbeing that may prompt a report include:

  • The child’s basic physical or psychological needs are not being met or are at risk of not being met (neglect)
  • The parents/caregivers have not arranged and are unable or unwilling to arrange for necessary medical care for the child
  • The child has been or is at risk of being, physically or sexually abused or ill-treated
  • The child is living in a household where there have been incidents of domestic violence and, as a consequence, the child is at risk of serious physical or psychological harm
  • A parent/caregiver has behaved in such a way towards the child that the child has suffered or is at risk of suffering serious psychological harm.

Any report made under the Act can be made anonymously and the maker of the report is protected from actions such as breach of professional etiquette or ethics, professional conduct or defamation.

If there is a possibility that disclosures about child abuse or neglect could be made in the conduct of your research, you should include a brief statement explaining your reporting obligations on the Participant Information Sheet.

Chapter 4.6 of the National Statement on Ethical Conduct in Human Research addresses research which may potentially reveal illegal activities. It identifies the following research where information gathered could lead to legal consequences:

  • Research intended to study, and perhaps to expose, illegal activity
  • Research not specifically intended to discover illegal activity, but likely to do so
  • Research where illegal activity is discovered inadvertently and unexpectedly.

If, during the conduct of your research, a participant gives you information about a serious indictable offence (a crime punishable by five years or more imprisonment) you are required to report the information to police or the appropriate authority. This is only where the offender has not previously been investigated/prosecuted and/or convicted for the offence.

Researchers may also be required to provide information about illegal activity that is disclosed to them during the conduct of their research if it is ordered by a court (eg. subpoena or search warrant).

If your research has the potential to collect information about illegal activity by participants or others, you should:

  • Clearly outline on the Participant Information Sheet and during the consent process any limits on confidentiality that are associated with your reporting obligations under the law
  • Consider the use of pseudonyms, or the removal of links between names and data, for participants whose illegal activity may be revealed or discovered in research.

Researchers must be clear to their participants from the start as to the circumstances in which they will breach the confidentiality of the data that the participant provides and what the researcher will do to avoid having to disclose confidential information.

UOW Staff and Students who wish to conduct research overseas, or with overseas participants*, must seek Ethics approval before commencing their research.

For projects taking place in a country or province that has an ethics review process equivalent to the NHMRC standard of HREC review, the local approval may be accepted by the UOW HREC via an ‘Acceptance of Approval by an External HREC’ without the need to submit a full New Application.  For example, receiving ethics approval from an IRB in the USA is highly likely to meet this requirement.  If you think that your research may fall into this category, please contact the Ethics Office for further information.

For projects taking place in a country or province that does not have an ethics review process equivalent to an HREC review:

  • Where there exists a local process for the review of research, this local approval must be sought in addition to UOW HREC approval. A copy of the local human ethics approval must be provided to the UOW HREC before the research commences.
  • In countries or provinces where there is no local ethics approval process, this must be outlined in the application.

There are additional ethical considerations which may arise from the differing beliefs, customs and cultural heritage of overseas populations.  Researchers must address these considerations in the Additional Form: Research Conducted Overseas which is to be submitted to the UOW HREC along with the UOW Application Form.

*Anonymous surveys which may include responses from people living overseas, but are not targeting overseas participants, are not likely to require this additional form.  Please contact the Ethics Office if you would like further information.

Chapter 2.2 of National Statement on Ethical Conduct in Human Research details the general requirements for consent. The basic principle is that consent should be informed and voluntary. Academics wishing to conduct research on university student groups, whether to evaluate their own teaching or for other purposes, need to ensure that the research is designed so that the students do not perceive any obligation to agree to participate.

Key considerations to be mindful of are:

  • There is an inherent power imbalance between university students and academic staff. This is greater when the academic is, or is likely to be, teaching the students in question, either now or in the future. It is always preferable to conduct research on students you do not teach.
  • If the research activity will take place in class time, the activity must be directly aligned with the learning objectives of the subject and this should be clearly communicated to all students invited to participate. The decision not to participate must not have any negative impact on student’s learning outcomes from that class.
  • Students must receive adequate notice of the activity, to allow time to consider whether or not they wish to be involved.
  • Active consent is always required where you are using student generated content e.g. journals, blog posts, assessment results.
  • When seeking consent to use student generated content for research purposes (including assessment material), to mitigate the risk of coercing students to consent (or students perceiving a pressure to do so) students should only be approached for their consent once grades are released.  Please note this also applies to situations where students are approached by researchers who are not involved in teaching the relevant subject.
  • Where the research is using student grades or student evaluations of a class, consideration should be given to how the identity of participants can be concealed from the teaching staff conducting the research. This may include having a third party de-identify the data, not analysing data until after subject results have been released, or both. Consideration should also be given to whether students are likely to encounter the relevant teaching staff in future subjects during their studies.
  • Where the research involves classroom observations but not recording information about individual students, opt out consent may be an option. Adequate information must be given to students to give them time to opt out. Consideration must be given to what these students do while the observations are happening, and how they can be excluded from the observations without making it obvious to others that they are being excluded or ostracising them from the rest of the class. Applications seeking opt out consent should explain how the proposed research meets each of the criteria for opt out consent as detailed in paragraph 2.3.6 of the National Statement. For useful guidance see the Scholarship of Teaching and Learning Human Research Ethics Resource Manual.

The NSW Ministry of Health website provides guidance on policies and links to forms to be used for applications involving NSW Health researchers, data or sites.

For NSW Health research the local HREC is not always the right HREC, this will depend on the location of the sites and the population involved in the study.

  • If your research is single site, or within a single Local Health District, you would normally use the local HREC.
  • If your research involves multiple Local Health Districts, you must use a Lead HREC.
  • If your research involves more than one jurisdiction participating in the National Mutual Acceptance Scheme the application can be lodged with a Certified Reviewing HREC.
  • Research involving Aboriginal and Torres Strait Islanders must also be reviewed by the NSW Aboriginal Health and Medical Research Council (AH&MRC) HREC.
  • Research using state wide data collections owned or managed by NSW Health must be reviewed by the NSW Population and Health Services HREC.
  • All human research projects undertaken with people in the correctional environment in NSW must be reviewed by the Justice Health HREC and the NSW Aboriginal Health & Medical Research Council HREC.  

Current Governance Processes

Applications involving NSW Health sites or researchers must be approved by the administration of the relevant Local Health District, which reviews governance issues (e.g. resource availability) related to the applications. The governance application form is the Site Specific Assessment Form (SSA); it is generated automatically when you fill in a HREA form in REGIS.

Governance approval is additional to the HREC review, which looks at applications for their compliance with relevant ethical and privacy guidelines and laws.

Contact the Human Research Ethics Team

(02) 4221 3773 (02) 4239 2191 uow-humanethics@uow.edu.au
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