Informed consent is a key ethical requirement. Participants must understand what the research involves and what will be done with their data before they consent to take part (see the National Statement).
The usual way to obtain informed consent is in writing, by use of a consent form that is signed by the participant and retained by the researcher as a record of the agreement. Because the researcher retains the consent form, there needs to be an information sheet for participants to keep, with the same details. Both the consent form and the information sheet should include the researcher's name and contact details, the title and brief description of the project, details on how the identities of participants will be protected (both when storing the raw research data and in its published form), a statement that participation is voluntary and participants can withdraw at any time, and provision for signature and date.
For further information regarding informed consent, and the requirements of such documents, please see Information Sheets and Consent Forms.
- Surveys on ANU staff and/or students.
- Provided that a privacy statement (i.e. warning) is prominently displayed, completion of the survey can be deemed to constitute consent. See Privacy and the Internet.
- The University values diversity and seeks to include all people in the community. To ensure that all people are treated in a dignified and non-discriminatory manner, in all cases where gender data is collected, the Researcher should provide a gender inclusive option on surveys. In practice this may require, at a minimum, providing an 'Other' or 'O' option for any question on gender identity. For further information see Guideline: Gender Inclusive Language and Discrimination Guidelines
The HREC needs to know how the researcher will address the issue of confidentiality, i.e. how the identities of participants will be protected in the raw research data and in any published material. Researchers must ensure that the privacy of their participants is adequately protected.
The Australian National University is the only tertiary institution established under federal legislation and so is bound by the provisions of the Commonwealth Privacy Act 1988. Of specific relevance are its 11 Information Privacy Principles (IPPs).The IPPs detail the requirements for collection, storage, use and disclosure of personal information.
The term "anonymous" is sometimes used incorrectly by researchers when they mean that identities will be suppressed in published material. 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.
In the consent form and information sheet researchers need to explain to participants how their privacy will be protected. Blanket guarantees of confidentiality (e.g. assurances of "strict confidentiality") are not helpful. If the term "confidential" is used in information provided to participants, a full description of what precisely confidentiality means in the context of a given research project should be given. Researchers should be aware that, under Australian law, any data they collect can potentially 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".
Privacy and the Internet
Increasingly the web is being used for surveys, but that raises particular privacy concerns. The Office of the Federal Privacy Commissioner has issued Guidelines for Federal and ACT Government Websites. These guidelines indicate the widespread concern among net users about a lack of transparency regarding the use and disclosure of personal information by websites, the tracking of individuals' activities at websites and concerns about the security of their information in the Internet environment.
The Privacy Act requires that a person be given details about what information is being collected, what purpose the information is being collected for, how the information will be used and if the information is to be disclosed, to whom it will be disclosed. It is important that a person be given sufficient information to enable them to make a decision about whether or not they wish to participate in the project.
Apart from the ethical issues involved, the HREC requires that any email or web-based questionnaire must include a privacy statement in order to meet the requirements of federal, State and Territory privacy legislation. The following is needed:
- The privacy statement or warning for potential respondents must be prominently displayed with any web-based survey, usually on the same page as the questionnaire or prominently linked to it
- Researchers using this methodology must familiarise themselves with the Office of the Federal Privacy Commissioner's Guidelines for Federal ACT and Government World Wide Websites
- If the survey is located on The Australian National University website, there should also be a hyperlink to The Australian National University's own privacy statement and its information on security provided.
At a minimum it should include the following information:
- What information is being collected about individuals when they visit the website or use email
- Why this information is being collected
- How it will be used
- If it will be disclosed.
A warning that there are risks associated with using the Internet as a transmission medium. (This applies also to emails, if this medium is to be used.) An offer to provide other options if possible for providing information, e.g. telephone or paper response. If any security measures, such as encryption, are provided, then information about this should be given. This could include a hyperlink to a brief statement on web security. At a minimum, the following should be included in the privacy statement. Additional information may be needed depending on each case:
Security of the website
Users should be aware that the World Wide Web is an insecure public network that gives rise to a potential risk that a user's transactions are being viewed, intercepted or modified by third parties or that data which the user downloads may contain computer viruses or other defects.
Purpose of data collection
This information is being sought for a research project entitled (TITLE). The researcher is (NAME AND CONTACT DETAILS, including ANU location). The project aims to (BRIEF DESCRIPTION OF PROJECT AIMS). The information you provide will only be used for the purpose for which you have provided it. It will not be disclosed without your consent.
Security of the data
The data will be kept secure by (DESCRIBE METHODOLOGY IN BRIEF). At the completion of the research project the data will be (DESCRIBE HOW THE RAW DATA WILL BE KEPT, FOR HOW LONG, AND WHAT WILL HAPPEN WITH PUBLISHED DATA) [e.g. will names be used, or other identifying details?] As the web can be an insecure medium you may choose to complete this survey by [provide alternate methods, e.g. telephone or mail out. If any security measures are being used, then provide information about these.]
Link to ANU website's disclaimer and privacy statement
To be included if your survey is located on The Australian National University website.
You can view The Australian National University's privacy statement.
How, Who, and What to do when it doesn’t go well
Recruitment is a critical ethical concern in human research, and it is one element of research on which the Ethics Committee particularly focusses. When preparing an ethics protocol, it is important that you describe recruitment plans and processes in detail, and that you be as realistic as possible when thinking about who might be willing and able to participate in your research. Remember, the central principle of voluntary participation underpins all recruitment efforts, and great care needs to be taken not to create conditions under which potential participants feel pressure to join in the research.
Sampling. For quantitative studies, you may have calculated a required sample size (e.g. to achieve a desired level of precision in your research outcomes), but such calculations generally rely on assumptions such as random sampling and independence between subjects, neither of which may genuinely hold. For qualitative research, for which the object may not be to generalise findings from a sample to a population – ethnographic studies are a useful example – other forms of “sampling” may be used. A term the Ethics Committee often encounters is “snowball sampling”, and 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.
Who to recruit. Think carefully about your target participant group, and be realistic about whether people will be happy to join your research. Sometimes a small incentive (e.g. a gift card) can help, but it needs to be small enough not to be regarded as 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 we in Australia enjoy, even $20 could be considered a coercive amount. If recruitment does not proceed as you plan, you may need to submit a variation to expand recruitment efforts, perhaps by using online platforms like Facebook, or by adding an incentive.
The bottom line on recruitment is that participants are to be respected and valued – they give freely of their time and effort, and recruitment is seldom as simple as it may initially seem. When submitting a protocol, be mindful that the Committee will want to know as much detail as possible about how recruitment will proceed – who, how, how many, and what you will do if initial efforts don’t work as well as you had hoped. Vague, overly optimistic descriptions about recruitment will generally not be accepted at face value, so time spent thinking through recruitment strategies before applying for ethics approval will be time well spent.
Use of lotteries or raffles
The HREC will not normally allow lotteries or raffles and does not want to encourage the use of them. However we will allow them when:
- There is clear potential that the research won't attract the required number of participants.
- There is no danger to participants, ie the research is not about addictive behaviour, gambling etc.
MOOC-based Research, edX and Human Research Ethics
The University recognises the increasing interest in conducting research using education data gathered from MOOCs. While the edX Terms of Service supports the carrying out of such research by explicitly making the availability of MOOC data a condition of course enrolment, the conduct of the research itself remains subject to the ANU Code of Research Conduct and the NHMRC's National Statement on Ethical Conduct in Human Research. The ANU Human Research Ethics Committee has considered research of this type and considers the main types of research to be of two broad types:
- Low/Negligible risk: research using data analytics that involves no "intervention" but rather involves analysis of de-identified learning analytics data would - ordinarily - involve no risk to participants. Such research can be carried out under the existing terms-of-service arrangements without formal ethics approval. However, assessments of risk to participants should be carried out on individual research projects and ethics clearance sought if specific risks to participants are identified.
- Greater than negligible risk: research that involves "interventions" (e.g. A/B testing where students are randomly assigned to different groups given different methods of instruction), in order to comply with the National Statement, must have provision for (a) informing students that they are participants in an experiment; (b) have arrangements for voluntary participation (i.e. the right to NOT participate in the experiment without giving up the ability to remain in the course); (c) a record should be kept of consent and withdrawal; (d) use of data and feedback on results should be made available to participants. Such research requires ethics approval from the HREC PRIOR TO DATA COLLECTION.
Professional Indemnity Insurance
Professional Indemnity Insurance is provided by the ANU Insurance Office. See the Certificate of Currency.
Research in Schools
If research is to be conducted with students in government schools then permission must be sought first from both the relevant Department of Education and the individual schools through the principal. In the case of private schools the permission of the principal may suffice. Please consult the Australian National University Research in Schools guidelines.
Researchers Seeking to Conduct Human Research in High-Risk Destinations
Researchers who are seeking ethics approval to conduct research in high-risk destinations (i.e. those declared by DFAT as "Do not travel" destinations within travel advisories at smarttraveller.gov.au) need to include with their ethics protocols detail for the Committees about risks to participants and themselves that may arise because of the high-risk environment within the countries that they wish to visit. Note that formal travel approval from the Vice-Chancellor is a requirement for ANU staff wishing to conduct research in such countries, and that this approval would normally require a formal risk assessment to be carried out for the researcher. Obtaining such formal travel approval is a separate process from the research ethics approval process, however it would assist the Committee in understanding the risks to researchers if any formal risk assessment details could be provided with the other protocol documents when submitting an ethics application. Researchers are encouraged to apply for the relevant travel approval as well as ethics approval well before they need to travel. Critically, the Committee is concerned about any risk to participants in these destinations that might arise through their participation in the research, and detailing the risks to the researcher alone will be insufficient for the Committee to be able to approve the protocol. It is recognised by the Committee that research of this kind will carry certain risks, but the Committee will be interested in assessing both the level of that risk and any risk management strategies that the researcher can put in place. Note that protocols that claim that there is no risk or negligible risk in such environments are likely to be carefully scrutinised and it is better for protocols to provide an honest assessment of the risk and for the researchers to develop strategies to deal with that risk, recognising that removing the risk entirely will almost certainly not be possible.
Intentional Recruitment of Aboriginal and Torres Strait Islander Peoples
Research involving Aboriginal and Torres Strait Islander peoples is particularly sensitive and has its ethical aspects reviewed by the full HREC. Central to such research are principles of respectful engagement and consultation. The AIATSIS Guidelines for Ethical Research in Australian Indigenous Studies states that "it is essential that Indigenous people are full participants in research projects that concern them, share an understanding of the aims and methods of the research, and share the results of this work. At every stage, research with and about Indigenous peoples must be founded on a process of meaningful engagement and reciprocity between the researcher and Indigenous people." Accordingly, ethical review of protocols involving Indigenous peoples requires evidence to be presented by researchers of such consultation and, wherever possible, letters of support from community leaders or organisations that attest to the willingness of the community to be engaged within the research. While it is understood that some documentation (e.g. permission to work within schools) may require ethics approval before it can be obtained, protocols will not generally be accepted for review by the HREC without evidence of consultation with relevant Indigenous communities and organisations, and researchers will generally be asked to provide relevant documentation as material evidence of such engagement and support.
Human Research Ethics and Research in Teaching and Learning
Education-based research projects for which our students are research participants bring unique ethical challenges, not least because the students have a dual role both as learners in a class environment and as research participants in an environment in which they might represent a dependent or vulnerable population. However, research in learning and teaching can - and must - proceed ethically. In 2014 the Australian Government Office for Learning and Teaching (OLT) commissioned Australasian Human Research Ethics Consultancy Services (AHRECS) to undertake work to help researchers construct ethical protocols for conducting education research. The AHRECS Scholarship of Teaching and Learning Research Ethics Manual consists of six booklets that include academic references, recommended reading and prompts for ethical reflections. The booklets are practically focused and incorporate examples of problems and suggested strategies.
Feedback to Participants
The Ethics Committee encourages researchers to proactively provide a summary of the project (not upon request or in an "opt-in" manner). 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 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 Integrity & Compliance
Research Services Division
Level 2, Birch Building 36
Science Road, ANU
Canberra, ACT, 2601