ANU researchers are responsible for “obtain[ing] any necessary written approvals from appropriate ethics committees, safety and other regulatory bodies, prior to commencing research…” according to Point 1 of the ANU Code of Research Conduct.
The ANU Ethics Committees for human research assess applications based on the NHMRC National Statement on Ethical Conduct in Human Research (2007 updated 2018) (henceforth National Statement, 2018). The guidelines in the National Statement are based on four key principles of respect, beneficence, justice and research merit.
Please note that when the research involves intentional recruitment of Aboriginal and Torres Strait Islander people, additional principles and guidelines set out in AIATSIS Guidelines for Ethical Research in Australian Indigenous Studies (GERAIS) and the NHMRC Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders also apply.
The guidelines set out in these documents are driven by these principles. Research, if in line with the guidelines set out in the National Statement and GERAIS, should similarly be driven by these principles.
What do these principles look like in practice?
On this webpage, we will cover what the principles of ethical research set out in the National Statement look like in practice, in general. A more detailed set of guidelines about what research with these principles looks like at each stage of the research process can be found in Section 3 of the National Statement.
We have a separate webpage on the additional considerations when conducting research with Aboriginal and Torres Strait Islander participants according to the guidelines in GERAIS. Research conducted with specific groups of people (e.g., children or the elderly), research in particular situations (e.g., in high risk destinations), or research about sensitive topics (e.g., mental health, terrorism, sensitive data) also require additional considerations. Policy and guidelines specific to these types of research are set out in the Policy and Guidelines for Specific Research Areas page.
Principles and Practice
- Minimising Risks of Harm
- Confidentiality, Privacy and Data Storage
- Informed Consent
- Feedback to Participants
1. Minimising Risks of Harm
Beneficence refers to the ethical principle of doing good and avoiding doing harm. All research has various kinds of risks of harm to different extents. Some examples of risks of harm include:
- Psychological harm: Does the research involve a risk of psychological harm, which may include feelings of worthlessness, distress, guilt, anger or fear?
- Physical harm: Does the research involve risk of physical harm which may include injury, illness or pain? This may include being humiliated, manipulated, or in any other way treated disrespectfully or unjustly.
- Legal harm: Could the research expose participants to potential litigation or the possibility for documents to be subpoenaed?
- Social harm: Could the research result in a significant negative impact upon personal relations? For example, could the research damage the relationship between a participant and another family member?
- Economic harm: These are harms which may have direct or indirect costs on participants, such as, potential loss of professional reputation, market standing, health insurance, or employability.
The researcher must seek to reduce and justify risks of harm arising from their research. In the ethics application, the researcher must demonstrate thoughtful consideration of these risks and how they will be managed.
2. Confidentiality, Privacy and Data Storage
The ethics committee reviewing your application needs to know how you will address the issue of confidentiality. Confidentiality is “the obligation of people not to use private information … for any purpose other than that for which it was given to them” (National Statement, 2018). In the context of research, this usually manifests in the obligation on the part of the researcher to protect the identities of their participants in the raw research data and in any published material.
Confidentiality and anonymity are not the same. The term "anonymous" is sometimes used incorrectly by researchers to refer to the suppression of identities of participants in published material. This is confidentiality, not anonymity.
- Confidentiality refers to the situation the participant has given identifying or potentially information about themselves to the researcher, but the researcher has kept these details hidden.
- Anonymity refers to the situation where the participant’s identity and responses cannot be identified, even by the researcher themselves. That is, the participant has not given identifying information about themselves to the researcher, so the researcher does not know who has participated in their study or who has provided which responses.
If individuals are identified or potentially identifiable in the raw research data, then it is not accurate to refer to them as "anonymous", even if they are not identified in any publications.
If the term "confidential" is used in information provided to participants (in the information sheet and consent form), a full description of what precisely is meant by confidentiality in the context of a given research project should be given. Researchers need to explain to participants how their information will be protected. Blanket guarantees of confidentiality (e.g. assurances of "strict confidentiality") are not helpful, because there are legally appropriate situations where confidentiality may be broken. For example, under Australian law, any data that researchers collect can be subpoenaed. Depending on the nature of the research, it may be helpful to qualify promises of confidentiality with terms such as "as far as possible" or "as far as the law allows".
Focus groups need particular provisions regarding confidentiality as group members may know each other, and will generally witness each other’s contributions. When focus groups are used, you should include advice in the Confidentiality section of your Information Sheet requesting that focus group members maintain the confidentiality of group discussions, and that individuals in focus groups should refrain from making statements of a confidential nature or that are defamatory of any person.
Third party identification
Sometimes, even when care is taken to protect the identities of participants, there is a risk of third party identification. This is the risk where participants are identified by what they tell you, despite your best efforts to hide their identities. This is more likely to occur in samples of small populations, or where the participant or their views are well known. Certain details about the participants’ identity may be given away if they describe their role in or experience of a certain event (e.g., where they are located, their age, etc.). Participants should be made aware of the risk of third party identification in the information sheet. If appropriate, measures should be taken to avoid third party identification (e.g., changing particular details such as suburb names arising from an interview). In certain situations, if third party identification occurs, this may be a breach of privacy law.
Privacy is a specific subset of confidentiality which is legislated. The Australian National University is bound by the provisions of the Commonwealth Privacy Act 1988 and this Act applies to situations where researchers collect personal and/or sensitive information.
As a researcher at the ANU, you will need to:
- Have a data management plan and that data storage meets ANU requirements and standards (see section on “Data Management” below).
- Provide sufficient information to participants about potential privacy issues so that they can make an informed decision about their participation in the project.
- Ensure that you do not collect any personal information beyond what is essential for the project.
Privacy Notice for the Information Sheet
If your research involves the collection of personal and/or sensitive information, such as (but not limited to) health information from participants, then you need to include a section in your Information Sheet on privacy to comply with the Privacy Act 1988. To comply with Australian Privacy Principle 5, a Privacy Notice must be included (please see Information Sheet template for this notice). The Information Sheet must provide details about:
- who is collecting the information,
- what information is being collected,
- what purpose the information is being collected for,
- how the information will be used, treated, accessed and stored, and
- if the information is to be disclosed, to whom it will be disclosed.
Privacy Statement for Web-based Studies
Increasingly the web is being used for surveys which raises particular privacy concerns. You need to ensure that these concerns, such as the use and disclosure of personal information and the tracking of individuals' activities, are considered and addressed.
More about Privacy
Key points include:
- As noted in the Information Sheet template, informing participants (prior to obtaining consent to participate in the research) about:
- what data will be collected,
- where their data will be stored,
- how long that data will be kept, and
- what will happen to their data after the required storage period.
- Establishing a data management plan and ensuring that data storage meets ANU requirements and standards:
Although a formal Data Management Plan (DMP) is not mandatory, it is strongly encouraged. The HREC may request that the researcher document their DMP for high-risk or large-scale projects. Information on how to create and manage a DMP using the DMPTool service can be found in the LibGuide on Research Data Management.
- Ensuring that the data is only accessed by individuals and in circumstances that are consistent with the Participant Information Sheet and Data Management Plan.
More about Data Management
Training on Data Management
Policies and Guidelines on Data Management
3. Informed Consent
Informed consent is a critical requirement for conducting research ethically. There are two aspects to informed consent:
- Is the participant given adequate information to make an informed decision about participating in the research?
- Can the participant consent to participate in this research? Has the participant voluntarily consented to participating in this research?
Participants must understand what the research involves and what will be done with their data before they consent to take part (see National Statement, Chapter 2.2). This information is communicated to the participant using an Information Sheet. This information sheet is kept by the participant. A template is available here to ensure that all necessary information is included is communicated to the participant. An example of how this template is to be used is available here.
There may be cases where the disclosure of information is limited (e.g., covert observation, deception). For guidance about conducting such research, see: Introduction – Chapter 2.3 and Limited Disclosure, Guidelines – Chapter 2.3 of the National Statement.
Consent must be based on adequate information about the research, and given voluntarily (free from coercion or pressure; National Statement, Chapter 2.2. See also Recruitment and Remuneration for Participants sections below). The usual way to obtain informed consent is in writing, by use of a written consent form that is signed by the participant, although there may be cases where consent is expressed orally (oral consent form template). The consent form is kept by the researcher as a record of the agreement.
There may be cases where a person other than the participant is involved in the consent process. Please refer to National Statement 2.2.12-13; National Statement Chapter 4.2: Children and young people, Chapter 4.4: People highly dependent on medical care who may be unable to give consent, and Chapter 4.5: People with a cognitive impairment, an intellectual disability, or a mental illness.
Further information regarding informed consent and the templates for these documents are available on the Information Sheets and Consent Forms page of our website.
Declining to consent and withdrawing consent
Participants are free to choose not to participate in a research project. They do not need a reason for their decision, and they should not suffer disadvantage as a result of their decision (National Statement 2.2.19). Participants who chose to participate in a research project may withdraw from the research at any time (National Statement 2.2.20).
All recruitment efforts must be underpinned by the principle of voluntary participation. Great care needs to be taken not to create conditions under which potential participants feel pressure to join in the research (National Statement 2.2.9), keeping in mind that people may feel pressure to participate even if that has not been the intention of the researcher.
In your ethics application, it is important that you describe recruitment plans and processes in detail: who, how many, and how people will be recruited, the reasons behind these plans, and what you will do if initial efforts don’t work as well as you had hoped. Be as realistic as possible when thinking about who might be willing and able to participate in your research. Vague, overly optimistic descriptions about recruitment will generally not be accepted at face value.
Who to recruit
“Who” is recruited to participate in your research depends on your research question. Think carefully about your target participant group. Inclusion and exclusion criteria must be clearly identified in the protocol (and why this is the case). It helps to be realistic about whether people from your target participant group will be happy to join your research, so you can adjust your target group and/or recruitment plans accordingly.
How many to recruit
For quantitative studies, you may have calculated a required sample size (e.g. to achieve a desired level of power or precision in your research outcomes when making statistical inferences). For qualitative research, where the objective may not be to generalise findings from a sample to a population (e.g., ethnographic studies) other reasons for the number of participants proposed and the method of recruiting participants (sampling) may be used.
How/how not to recruit
- Snowball Sampling. Researchers need to be aware that such an approach may create conditions for potential participants whereby they feel pressure to join the research because they have been referred by a friend or colleague. It is particularly important in such cases to ensure that the principle of voluntary participation is stressed in information given to potential participants. It is also important in this vein to explain to potential participants that research typically will not benefit them directly. Even though this advice may seem to limit the prospect that they will join, it is essential to the ethical conduct of research.
- When recruiting does not go as planned. If recruitment does not proceed as planned, you may need to submit a variation to expand recruitment efforts, perhaps by using online platforms like Facebook, or by adding an incentive.
- Incentives/remuneration. Sometimes, a small incentive (e.g., a gift card) can encourage people to consider participating in your research, and is also an appropriate gesture of thanks for the participants’ time and effort. However, the researcher must ensure that this incentive is not coercive. See the section on “Remuneration for Participants” below.
5. Remuneration for Participants
NHMRC has published advice for researchers and reviewers about when payment of participants in research is ethically acceptable. This advice is now available on the NHMRC website:
According to the National Statement (2018), “Decisions about payment or reimbursement in kind, whether to participants or their community, should take into account the customs and practices of the community in which the research is to be conducted” (2.2.11). For example, the researcher should consider:
- Is it appropriate to give a payment, gift or reimbursement to participants? If a gift is given, what kind of gift is appropriate?
- When making a payment or purchasing a gift, what amount is appropriate? The key here is that this payment or gift should be an expression of appreciation, but not an amount that is coercive.
Incentives. Sometimes, a small incentive (e.g., a gift card) can encourage people to consider participating in your research, and is also an appropriate gesture of thanks for the participants’ time and effort. However, the researcher must ensure that this incentive is small enough to be not coercive. “Small” is relative, as well – if you are recruiting medical professionals, you may need to pay hundred(s) of dollars as an incentive; if you are working in an overseas community with much lower incomes than in Australia, even $20 could be considered a coercive amount. Incentives must be paid to participants even if they choose to withdraw during the research study.
Reimbursement. Similarly, it is “generally appropriate to reimburse the costs to participants of taking part in research” (National Statement 2.2.10). For example, costs of travel, accommodation and parking may be reimbursed, and/or reimbursement for the time involved in the research. 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” (2.2.10). This, again, depends on the community within which the research is to be conducted.
Use of lotteries or raffles
The ANU HREC will not normally allow lotteries or raffles and does not encourage the use of them. However the HREC will allow them when:
- When there is clear potential that the research won't attract the required number of participants using other forms of recruitment.
- When there is no danger to participants, i.e., the research is not about addictive behaviour, gambling, etc.
- When a separate permit is not required. The rules for this vary from state to state and may change over time.
Currently, in the ACT, a lottery or raffle used as an incentive in research is a Trade Promotion Lottery. For an ACT Trade Promotion Lottery, the total prize must not exceed $3000 and certain conditions must be met for it to be considered “exempt” (from requiring a permit).
6. Feedback to Participants
It is expected that the outputs or outcomes of the research will be made publically available if possible (e.g., in a peer-reviewed journal, a conference presentation, etc.) as part of the research process. In addition to this, the ANU Ethics Committees encourage researchers to proactively provide a summary of the project to all participants (not upon request or in an "opt-in" manner). This practice is also encouraged in Point 17 of the ANU Code of Research Conduct.
Feedback could be provided by setting up a website or a file sharing service (such as Dropbox or OneDrive), and providing the link in the Information Sheet. If you choose to share the overall summary report via Dropbox or OneDrive (available to all ANU staff, students and affiliates via your Office 365 account), you can create a blank document, upload it to your account, and share it. Once you click on "share", a link will be provided. You can add that link to the Information Sheet. Once the final report is ready, you just need to replace the blank document with the summary report (using the same filename). Be sure that you allow anyone with the link to see the file.
The Australian National University takes every complaint seriously. Once a complaint has been submitted, the HREC will investigate the allegations. Investigations may take up to 6 weeks, if you wish to make a complaint, please contact:
Human Ethics Officer
Research Services Division
Level 1, Geography Building, Building 48A
Linnaeus Way, The Australian National University
ACTON ACT 2601
If you have a specific concern regarding research misconduct or integrity, please contact:
Research Integrity Enquiries
Research Integrity Office
Research Services Division
Level 1, Geography Building, Building 48A
Linnaeus Way, The Australian National University
ACTON ACT 2601