Frequently asked questions
Have questions about the ethical requirements surrounding human research? Find your answer here.
Obtaining and managing ethics clearance
Swinburne and its researchers are committed to and bound by applicable principles, guidelines, standards and regulations, as are any researchers of institutions getting public funding. The most important of these is the Australian Code for the Responsible Conduct of Research 2007 (updated 2018), which describes a strong research culture as demonstrating the following principles:
Putting forward research proposals for independent review (peer and/or ethical review) that have been carefully prepared and critiqued assists with demonstrating good ethical and professional standards. Robust ethical review can help demonstrate research merit and integrity and, above all, show respect for the rights and interests of human participants or show justifiable animal use or environmental impact. Appropriate commitment and conduct on the part of researchers completes the picture.
‘Peer review’ is a review of the research project underlying the ethics application, not the application itself. The review is conducted by an expert in the project’s research domain, by a person who may or may not be affiliated with Swinburne. The peer review cannot be provided by a person listed on the ethics application or who is directly involved in the project, as this would represent a conflict of interest. The peer review is designed to evaluate the project’s scientific merit, not its compliance with the National Statement.
It is strongly recommended that researchers obtain a peer-review for applications that require review by SUHREC. Please state in the ethics application how the feedback from the peer review has been incorporated into the project/application and include the peer review template with your application.
Download our recommended template for seeking peer-review [DOCX 801KB].
‘Pre-review’ is a review of the ethics application itself, not of the underlying research project. It is usually conducted by a Swinburne Ethics Advisor who is not involved in the project. It is designed to ensure applicants have filled in the ethics application form correctly and in compliance with the National Statement.
Once you have established that your proposed research requires ethical review and approval before commencement — including actively recruiting for participants — you should read our other webpages and check for:
the type and level of ethical review
the correct forms and templates to be used
the procedures to follow
the deadlines for submission.
All human ethics applications must be lodged online using the Swinburne Ethics Review Management (ERM) platform.
Note: A student or sessional/adjunct staff member cannot be listed as the Chief Investigator on an ethics application. The Chief Investigator must be a Swinburne staff member and the adjunct/affiliate/visitor named as an Associate Investigator, if appropriate.
The main committee (SUHREC) meets 12 times per year, every 4–5 weeks. Any SUHREC sub-committees (SHESC) meet approximately 35 times per year, 1–2 weeks apart, depending on the time of year. Applications deemed eligible for negligible risk or expedited review are reviewed out-of-session.
It takes approximately three weeks to hear the outcome of an ethics clearance application from the time of the published deadline, or approximately one week after a scheduled review meeting. If an application has been well prepared with all requisite signatures, clearance would be issued within this period. If there are queries or concerns about the research proposals, including recruitment and consent arrangements, then it takes longer.
If queries or conditions for approval have been raised that must be satisfied, progress will significantly depend on when researchers submit their responses and on the availability of ethics committee or subcommittee delegate(s) appointed to consider the responses. In most cases, responses to queries will only need to be put to a committee delegate and not wait until the next scheduled meeting to be processed. Once the delegate is satisfied with the researcher responses, clearance will be issued. For the most part, approval by a delegate should not take more than five working days.
However, where a project has been sent back for resubmission, this usually will be subject to standard meeting and application cycles unless otherwise advised.
When a project protocol has not been approved as submitted, it is usually due to significant lack of detail, the information given is unclear, the research questions or methods are not clearly articulated, any of the risks involved are not justified by the benefits, or because some other key research and ethical issues have not been identified and addressed.
Please also be aware that where a project application has not been approved, most times this means that a full rewritten submission is needed for fresh review with a statement addressing any queries raised, point by point. The reviewing body can delegate further review of the resubmission to nominated delegates only for expedited review but this is less common.
The ethical review body or reviewers are part of the ethical review and monitoring equation. As mentioned in the National Statement on Ethical Conduct in Human Research (2007) updated 2018:
“the researcher should demonstrate that the research has merit and reflects the values of justice, beneficence and respect for humans (NS 5.2.5)”.
the ethical review body member or equivalent “is responsible for deciding in his or her judgement, a proposal submitted … meets the requirements of the National Statement and is ethically acceptable (NS 5.2.2)”.
Bear in mind that this is a regulated and auditable process. When clearance has been issued, it is for what is actually submitted to date and approved; what is not submitted and/or not approved would not be covered. For example, if you have argued for only interviewing 12 participants and this is approved, that is what you have approval for. To increase the number of participants, you would need to apply for ethics clearance with sufficient detail, explanation and justification.
Another example: If you say that you will only be recruiting participants with Type A Condition and this is approved, you cannot then also recruit participants with Type B Condition. If you are only going to conduct anonymous surveys with implied consent, you cannot also conduct interviews unless you get timely prior ethics clearance.
Please ensure that:
you have the proper ethics clearance issued by Swinburne Research before you conduct human research activity, including actively recruiting for research participants
you do not vary or add to the approved research before you apply for and receive the proper ethics clearance for what is proposed
you obtain all the necessary permissions or clearances additional to Swinburne ethics clearance to conduct various elements of the research
you continue to monitor or self-audit the conduct of the research to ensure compliance with the terms of ethics clearance or other permissions
you report, as soon as practicable, any incident or event that affects the continued ethical acceptability of the research, especially any incident or event that impacts or would impact adversely on research participants, researchers or others.
Yes, you can. However, the proposed modifications must be approved by the ethics committee or delegate before the changes are implemented. Please do not proceed with implementing any changes before such approval is obtained.
You can find more information on how to submit a modification request here.
A rare exception is that you can change or modify an approved protocol without prior clearance in an emergency to prevent or minimise harm. In this instance, you still need to notify the Research Ethics Office as soon as possible to ensure continuing ethics clearance. Depending on the circumstances, ethics clearance and the research may need to be suspended or even withdrawn.
In order to add new staff or students to a project, a modification request must be submitted – see here for more information on how to do so. If data collection is still ongoing, the name(s) of the person(s) should be added to the Consent Information Statement and other relevant documentation.
For projects that involve the new person(s) having access to identifiable or re-identifiable data that has already been collected, and/or data that is considered more than low-risk (even if non-identifiable), the Chief Investigator (CI) is responsible for ensuring that existing participants give their consent for the new person(s) to access their existing data. Ideally, this will be accomplished through the use of a revised Consent Information Statement and Consent Form. If this is not possible, the CI must apply to SUHREC or one of its sub-committees for a waiver of consent (see National Statement Section 2.3.10). For low-risk projects in which the data is de-identified, it is not necessary to re-consent participants, however, the Research Ethics Office still needs to approve the addition of the new personnel.
Exempt or non-exempt research
Specifically, in line with 5.1.22 of the National Statement on Ethical Conduct in Human Research (2007) updated 2018, research will be exempted if it is:
negligible risk (i.e. the only foreseeable impact on human beings would be negligible at worst, with no risk of discomfort or harm)
involves (pre)existing collections of non-identifiable information (the information in its original form contains no names or unique identifiers, nor allows identification by virtue of the sample or method even though anonymous).
Please note that in exempting projects as per the above criteria, it is implied that the applicable ethical and other standards set out in the National Statement are still being met.
Under current guidelines , activities that may also be exempted includess Quality Assurance (QA) or Quality Improvement (QI) projects, some limited consultancies, class training exercises within the classroom or course setting and observational work placements as part of coursework — all of which are undertaken in line with the following provisions, as applicable:
there are no research outcomes (such as dissertations/theses or mini theses, journal/conference papers) anticipated
the activity is solely for internal Swinburne purposes (especially for QA/QI projects)
the activity is fully within a work or professional placement (as with student placements or with staff consultancies) where the activity is within legitimate or publicly expected limits
the activity will be respectful of the rights and interests of those being studied or observed and any foreseeable impact on those being studied or observed will not be adverse.
Also exempted would be:
critical discussion amongst colleagues
critical comment at a candidature symposium
contribution or exchange of private views whether solicited or not including at an academic conference or seminar (in contradistinction to actively collecting data to analyse for research purposes)
provision of bona fides expert comment on topical matters, including in the public arena
standard citation of sources of information or opinions in published material
unsolicited but privately communicated comment.
Further information is available from the Research Ethics Co-ordinator.
Yes. According to the National Statement on Ethical Conduct in Human Research (2007) updated 2018, this would be human research needing ethical review and approval in line with the National Statement at some level. Please also refer to other advice on using email for recruitment, consent and/or participation arrangements, or research using the internet, blogs and social networking sites.
If it’s being done for a purpose other than for internal Swinburne operational or management purposes, then ethical review is usually needed. If you anticipate presenting or publishing a paper using data relating to people involved in a program, then you will need to apply for ethics clearance at the appropriate level.
Multi-site and transferred research
Scenario 1: I have received ethics clearance from and conducted research with or at XYZ University/Hospital — can I transfer the research and clearance?
Scenario 2: I will be conducting research with or at XYZ University/Hospital — do I need to get ethics clearance or permission from XYZ?
Firstly, there is a research governance matter needing attention: what has actually been authorised by whom and for what? In other words, what has been cleared elsewhere is unlikely to have simple coverage at or for Swinburne. What is undertaken under Swinburne’s name ordinarily is likely to require authoritative Swinburne ethics clearance. If you are not properly covered by a proper Swinburne process, you may be in breach of applicable policies, procedures, standards or guidelines, in which case you may not be able to conduct, complete or claim the research.
It is important, therefore, that you are aware of all the necessary permissions and clearances needed to conduct research at or with other organisations for any stage of human research activity, including data collection, whether with or without clearance(s) from one or more research and/or ethics committee. The main reason is that each organisation is usually a separate legal entity subject to or liable under various applicable regulatory, professional or contractual regimes. And in some cases, a funding or research agreement may be needed or warranted to cover the type and extent of collaboration.
These agreements, by the way, rarely if ever include simple delegation to another organisation of ethical review or liability under various laws. At best, the agreements and adherence to the agreements prevents or minimises problems in the event of something going wrong.
Swinburne, as with a number of other organisations, works to minimise duplication of ethical or other review. All things being equal, expedited ethical review may be available if the ethical review already undertaken accords with Australian research ethics standards.
Find information on how to apply for expedited review using Swinburne Ethics Review Management (ERM) here.
The simple answer is yes—any research conducted under Swinburne auspices must meet applicable standards and guidelines. For human research, the requirements of the National Statement on Ethical Conduct in Human Research (2007) updated 2018 must be met at a minimum; to some extent, other guidelines can be used provided these are consistent with the National Statement and a Swinburne ethical review body (SUHREC or delegate) can review the proposal and recommend approval.
Please note the Chief Investigator on the application must be a Swinburne staff member and the adjunct/affiliate/visitor named as an Associate Investigator, if appropriate.
Unless otherwise authorised, the Swinburne ethical review can only cover what is being undertaken under Swinburne auspices. To the extent that other or external interests are at play, these need to be clarified in the application and, as applicable, for consent purposes. Data management and research outcomes also need to be clarified.
If the research only involves Swinburne staff or students as research participants (not as co-investigators) and prior ethics clearance has been obtained from a non-Swinburne institution in line with the National Statement on Ethical Conduct in Human Research (2007) updated 2018, additional or separate Swinburne ethics clearance will not ordinarily be necessary.
Depending on the details, the external researcher will need to identify the appropriate Swinburne authority to seek ‘gate-keeper’ or other appropriate approval to access Swinburne staff or students via Swinburne channels or involving Swinburne resources. As part of that request, evidence of the ethics clearance obtained should be submitted, including also making available a copy of the information being used to obtain consent.
With regard to Swinburne staff or students undertaking research as supervised students of another (non-Swinburne) institution, care is needed to identify and address any issues such as power relationships, dual interest, conflict of interest and any access to privileged information.
Ethical issues and risk assessment/management
Given the guidelines that apply to the conduct of human research, this can and would be challenged. Any human research activity can be said to have ethical implications by virtue of any involvement of or the impact upon humans in some way. Four ethical values are identified and discussed in the National Statement on Ethical Conduct in Human Research (2007) updated 2018:
research merit and integrity
beneficence (or non-maleficence)
To some extent, respect for human beings also includes the other values (see National Statement Section 1).
Subjecting research proposals for independent review is a significant way to demonstrate awareness of and commitment to the ethical conduct of research according to the above values. Other ethical and professional perspectives or approaches, consistent with these values, should also be considered.
The National Statement on Ethical Conduct in Human Research (2007) updated 2018 assumes human research is conducted with some element of risk whether negligible, low or not low, as outlined in Chapter 2.1 Risk and Benefit. A “risk is a potential for harm, discomfort or inconvenience” involving a likelihood of its occurrence and the severity and consequences of it occurring. Further, risks range from negligible (foreseeable as inconvenience, such as an anonymous survey requiring a few minutes to complete) to low-risk (foreseeable as discomfort, such as being asked some sensitive questions that would not lead to distress) to not low-risk (risk of distress or harm).
Within this context, “research is ethically acceptable only when its potential benefits justify any risks involved”. Risks need to be identified, assessed and prevented (if possible) as well as minimised or otherwise managed. Simple claims should be avoided. An ethics clearance application should demonstrate that the relevant issues and risks have been identified and addressed.
Provided it can be demonstrated that the research is negligible or low-risk, according to criteria set by the National Statement on Ethical Conduct in Human Research (2007) updated 2018 and/or by Swinburne, this should be fine.
In this regard, you need to be clear about the criteria set out in the National Statement as to what is or is not 'negligible risk' or 'low risk' research and/or with regard to specified vulnerable or other groups of participants that may require higher level ethical review.
Please also consider other perspectives: you might think from your perspective that the proposed activity is unexceptional or without risk, but others may not, particularly in relation to who is involved and how. Simple statements like: 'The research is low risk because it is anonymous/conducted online' or 'because it is a validated questionnaire' do not help. You need to demonstrate that the proposed research is negligible or low risk or does not involve vulnerable people.
For example, you need to be fully aware of what you are doing: administering a validated anonymous questionnaire online which asks about illegal activity is not low risk, particularly if a third party can access or ‘hack’ the online site or system; administering a validated anonymous questionnaire that reawakens distress or can give rise to a serious negative self-image or be suggestive of an illness is not low risk. It does not mean you cannot or will not be able to administer such questionnaires; rather the ethical review level (usually full HREC review) needs to account for what is proposed and will be approved.
In the case of Swinburne neuroimaging equipment, such as MRI or MEG, you would need to obtain prior endorsement from the Swinburne Neuroimaging Facility before submission for ethical review and include a copy of the applicable forms in the ethics clearance application.
There should be avoidance of simple statements that declare no risk with the use of MRI or MEG even though there is a safety record. In the case of MRI, careful attention is needed with the possibility that scans can disclose a health-threatening condition and how this needs to be sensitively managed by the researchers. Even with MEG, a participant may suffer from claustrophobia or other condition from being alone in the room that is shut for the duration of scanning.
In the case of research involving biohazards, such as working with biospecimens, there may be a need to request advice or clearance from or follow a procedure approved by the Swinburne Biosafety Committee before submission for ethical review. Check with the Research Ethics Office first if you are unsure about what risk management processes need to be followed before applying for ethics clearance.
For further information please contact the Research Ethics Office.
In line with applicable parts of the National Statement on Ethical Conduct in Human Research (2007) updated 2018 (including Chapter 4.6 – People who may be involved in illegal activities), research can be conducted ethically with or about people who may be involved in illegal activity or otherwise conduct legally sensitive research.
The research aims or methods:
may intentionally study, perhaps to expose, illegal activity
though not intentional, will likely discover or uncover illegal activity
may inadvertently or unexpectedly discover or uncover illegal activity.
Illegal activity includes traffic offences, various forms of abuse including bullying (especially of the vulnerable), non-compliance with regulatory regimes, non-reporting of information or situations subject to mandatory reporting, possession or use of illegal substances or illegal use of substances, and more.
It is important to note:
Swinburne does not countenance and will not support illegal activity
Swinburne’s public liability and professional indemnity insurance policies will not cover illegal activity knowingly engaged in by Swinburne personnel carrying out Swinburne business.
Questions that should be asked include:
When conducting research in Australia or overseas, have you identified and addressed all relevant legal, ethical, professional and other issues?
What impact will your research have? What harm can result from the research and to whom? Is it likely that Swinburne’s reputation may be adversely affected?
Do you have the expertise to conduct the research, such as knowing applicable laws or being able to handle the expected or the unexpected given the circumstances? Will you be subject to mandatory reporting?
Should the research be conducted as proposed if there is an alternative that is either not sensitive or less sensitive?
Do the anticipated or potential benefits justify any of the risks involved?
Are your methods carefully thought through, especially with regards to ‘sensitive information’? If you can collect and use only anonymous or non-identifiable information, you should do so.
Also consider or be alert to the following:
Researchers should be fully aware that they are researchers and not enforcers of law (or enforcers of morals).
Researchers may be wearing more than ‘one hat’ or ‘a researcher’s hat’ — for example, the researcher being both a researcher and a treating health professional.
While confidentiality should be respected at all times, an absolute guarantee cannot ordinarily be given. Under some circumstances, your data could be subpoenaed.
You need to be aware of instances where mandatory reporting pertains (such as child abuse) and failure to do so is illegal.
In the course of conducting confidential or sensitive research, a moral dilemma can be encountered and a decision may be needed to prevent harm. Are you equipped to do so?
Research involving human participants must be approved by the Departments of Defence and Veterans' Affairs Human Research Ethics Committee (DDVA HREC) as well as SUHREC where one or more of the following apply:
research is conducted on Defence members, ex-serving personnel or other Defence personnel, their information or tissue
participants are to be recruited, either directly or indirectly, through a service provided by Defence or the Department of Veterans' Affairs (DVA).
research is conducted by Defence or DVA personnel
research is conducted on/in a Defence establishment.
research is sponsored, endorsed or funded in any part by Defence or DVA.
Information on how to apply for ethics approval is available from the Departments of Defence and Veterans' Affairs Human Research Ethics Committee (DDVA HREC).
Once ethics approval has been received from the DDVA HREC, you can apply for expedited review at Swinburne.
Please ensure that the proposed use of a transcription service is either outlined in the application or submitted as a modification request, if its use hasn’t been determined prior to ethics clearance.
Recommended transcription services are:
Data management (collection, use, disclosure, retention and disposal)
Data needs to be securely retained and then securely disposed or destroyed when no longer needed. How long the data or material need to be retained depends on the type of research or data. Basically, research data should be retained for as long as there is a need for referral to the data, such as to justify or defend the research, or to satisfy legislative or some other standard.
Some minimum standards are:
For most research, the minimum recommended standard is five years from the date of any outcome based on the data.
For short-term projects that will not lead to published outcomes and are only for assessment purposes, the minimum period should be sufficient to cover the assessment period (including any appeals in case of dispute).
For identifiable health research data collected, the minimum period may need to be seven years after the last health-related usage or service provision, or five years after any research outcome based on the data, whichever is the longer. Health records legislation may have application here and Swinburne's privacy guidelines should be consulted.
For identifiable health research data involving minors, the data may need to be retained until the individuals turn 25 years of age, or five years after any research outcome based on the data, whichever is the longer. Health records legislation may have application here and Swinburne's privacy guidelines should be consulted.
For adverse incidents occurring during or as a result of the research that have health implications, the standard applying to health records should be followed.
For most clinical trials, at least those involving substances being administered to individuals, the retaining of research data for 15 years or more may be necessary.
For research data for areas such as gene therapy, the retention period should be permanent.
For research data that has heritage or community value, archival standards would apply, preferably in a national collection.
You may also need to be alert to other applicable standards and requirements, eg, if you have approval to include a voluntary prize draw or lottery, you would need to satisfy record-keeping requirements under gaming regulation.
Please consider using Swinburne OneDrive for Business for secure storage of research data.
See also our information on data management.
Data access or sharing is encouraged in the Australian Code for the Responsible Conduct of Research ((2007) updated March 2014. Sometimes it is a research funding condition that data from the funded project be made available or deposited for further or future use. Good data access or sharing arrangements can minimise research duplication or minimise unnecessarily inconveniencing or burdening research participants. Careful consideration should therefore be given to this matter when planning research, with due regard to applicable or relevant ethical, legal, privacy or confidentiality standards. Useful discussion is provided by the Australian National Data Service on ethics, consent and data sharing. See also information on data management on the Swinburne Research intranet. on the Swinburne Research intranet.
For data to be collected, you should carefully prepare the ground that permits what you intend or anticipate. In this respect, informed consent arrangements become significant, including effective wording of consent instruments to enable sharing or use for further research including by others. Also, the methods of collection and retention should be secure and maximise, where appropriate, anonymity and/or confidentiality.
For useful advice on de-identifying data, please see the Office of the Australian Information Commissioner’s/CSIRO’s Data61’s De-identification Decision-Making Framework.
For data already collected, the situation warrants close, careful attention to ensure professional, ethical and legal requirements or standards are met. You need to clarify the previous or current situation and what is being proposed.
Questions to ask include:
Who owns or controls the information?
For what purpose was the information collected or retained?
Did the data collection include informed consent?
What does the information contain that is relevant or necessary for what is now proposed?
In what form is the information held?
Can the information collected be used for a new purpose?
What are the benefits of the new purpose?
Put very simply, if the new sufficiently detailed proposal demonstrates that:
there exists sufficient informed consent and evidence is presented for this
the new purpose is not against the interests of those whose information is to be used
there is substantial public interest or benefit involved
then the ethical review should yield a positive outcome. If there is not sufficient evidence of consent for the new or secondary purpose, then see our section about consent waivers.
Clear thinking and language are usually needed regarding what is involved or proposed. For example, original data from which research data are extracted could be identifiable in some way. What identifiers, if any, are still being accessed or used?
Given this, clarity is needed as to what is or is not properly or fully identifiable/non-identifiable, or individually identifiable or not. Being non-identifiable should or must mean there are no identifiers contained in the data that could lead to identification of an individual or small group.
Sometimes 'anonymous' is interchangeable with 'de-identified' but this cannot simply be assumed. 'Anonymous' literally means 'no name'. 'De-identified' can mean the temporary removal of some identifiable information and replaced with a code that can be used for later (re)matching.
Sometimes anonymity is equated with confidentiality, which is a mistake and even risky. Depending on the context and the data and/or method, someone’s identity can be disclosed or worked out relatively easily and, as a result, confidentiality is breached, even though the information collected, used or disclosed is anonymous.
Chapters 3.1.40 to 3.1.62 of the National Statement on Ethical Conduct in Human Research (2007) updated 2018 has some good discussion on types of information access, use or retention.
This is fine but some caution is needed about what is publicly accessible or available and how. Swinburne researchers are beholden to appropriate or applicable regulatory, ethical and professional standards and guidelines when proposing or conducting research.
If human research activity is taking place, then research proposals would need formal ethical review at the appropriate level. One matter to appreciate is the concern regarding how information has been collected and used. Sometimes this is expressed in the questions "how did the researcher get my contact details?" or "who is keeping tabs on me?" or the statement "I gave my information for a particular purpose only, not for just any use."
Is identifiable information about individuals seen in a public record being recorded by a researcher? In some circumstances the information recorded could in effect be deemed "personal information" or "health information" and is then subject to applicable federal or state privacy legislation or professional/ethical standards based on the privacy legislation. The applicable standards are variously referred to as: "Information Privacy Principles (IPPs)", "National Privacy Principles (NPPs)", "Victorian Information Privacy Principles (VIPPs)" and "Health Privacy Principles (HPPs)", depending on the legislation or jurisdiction.
Using the telephone directory to select and contact participants can also raise a question or two. It is not necessarily that you cannot use the telephone directory for research purposes, but some care is needed to minimise or prevent unnecessary concern on the part of individuals affected. A concern can be who is keeping tabs on a participant? Is it necessary for a researcher to keep a database of identifiable information/contacts? If a database were to be built up from publicly available information and kept as a database of some sort, this would need to be consistent with applicable privacy principles/standards; if the database is for research purposes, then prior ethics clearance would be needed for this. In certain cases, it may also mean notifying the individuals concerned with their right to opt out of the database.
Stricter guidelines can apply. For example, the publicly available Electoral Roll can only be used in line with what the Electoral Act mandates or allows. A shareholder listing may only be used in line with the purpose for which it was collected and disclosed. Please also be aware of restrictions covering publicly available probate or land title records that are not exempted under privacy laws.
Information collected or used from social networking sites or the internet also require some care, such as noting if there are explicit conditions of access or use.
The National Statement specifies:
“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. Therefore, use of such information will need to be considered in the context of the need for consent or the waiver of the requirement for consent by a reviewing body and the risks associated with the use of this information.”
Journals are increasingly requiring the inclusion of raw data with submitted manuscripts. It is recommended that you allow for this possibility in your ethics application. For more information on ethics requirements for research publication, please see this guide and our webpage exploring this situation.
Obtaining information via Freedom of Information requests is a lawful means of obtaining information and the National Statement doesn't indicate that such a method of obtaining data is precluded. However, researchers need to carefully consider whether the Freedom of Information Act is the correct 'tool' for such data collection when other, more established mechanisms, might be more appropriate given the limitations, potential risks and costs associated with data collection via FoI means.
Please ensure you have discussed this approach with an internal expert (such as Matthew Smith via +61 3 9214 4592 or email@example.com) or external FoI expert before approaching the Research Ethics Office. Consent waiver requirements of the National Statement may also need to be taken into consideration when obtaining data this way.
The Ethics Office is increasingly seeing applications for use of data gathered from digital devices such as accelerometers or pedometers which measure human activities including such things as: sleep quality, pulse rate, blood pressure, menstrual cycles – or even COVID-19 vaccination ‘passes’. Other examples include Fitbits, exercise trackers, calorie monitors, smart rings, head-mounted displays, smart glasses, etc.
Applicants are frequently unaware that the companies making these devices will likely retain a copy of all the data produced by their devices for re-use by the manufacturer – either to improve their products or to sell to other companies. Privacy Statements available on the manufacturers’ websites, are frequently limited or non-existent.
More and more companies make use of Internet of Things (IoT) capability to collect the data from the rapidly growing number of gadgets and devices in use. While the privacy and confidentiality risks of such hidden data re-use are fine for any device an individual buys for personal use, more and more information is becoming available on the risks associated with the convenience of automated data capture and re-use (see, for example Digital Devices Took Over Our Lives In 2020: Here's How To Stay Secure.
Very few of the investigators using digital devices to collect participant data mention the privacy and confidentiality risks for their participants.
The National Statement highlights the need for researchers to notify participants about third party data access (see NS 3.1.66 & 3.1.67). If you are planning to use any digital device to collect your participants’ data – from a smart phone to a sophisticated medical monitor – please ensure that your Explanatory Statement identifies the potential privacy risks involved and that your Consent Form includes an explicit yes/no option for your participants to check.
Incentives and recruitment
The National Statement on Ethical Conduct in Human Research (2007) updated 2018 allows for fair reimbursement for participating in research and proposed payments should not be such as to impair voluntary participation. Incentive payments present more of an issue and, as with unduly large payments, would not be justified if it means that the research and related risks are not fully appreciated. It should be noted that the National Statement makes no allowance for rewards or bonuses for participating in research and there can be no penalty imposed for participating in research or not.
Where participants are invited to enter into a prize draw as a thank you for taking part in research, the prizes should not be an inducement that impairs voluntary informed consent. Where a prize draw is proposed for implementation in Victoria, Victorian gaming regulations may apply, in particular the current terms and conditions for a Trade Promotion Lottery.
In proposing the use of a prize draw, the arrangements need to be sufficiently disclosed both in the ethics clearance application and in information being issued to participants, including:
that entry into the prize draw is voluntary (note that some may object to gaming)
how the participant can enter and by what date (in some cases, a quite separate procedure may need to be arranged and spelt out to ensure anonymity of research participation)
on what date names will be drawn for the prize
how and when winners will be notified in writing (if they have won a prize and the value of the prize is above $1,000 then further notification requirements are likely to apply)
contingency for non-collection or non-acceptance of a prize
what the minimum period is for retaining records for administering the lottery.
Importantly, the arrangements for the prize draw should be fully consistent with applicable regulatory and ethical standards, including arrangements to respect and ensure anonymity and/or confidentiality. For example: it would be problematic to say to participants that their participation would be anonymous even to the researchers, then require a participant to collect a prize from the researchers.
Also be aware that, given the research inclusion criteria, disclosure of participation may also be disclosure of a condition or behaviour and this may be inconsistent with assurances of and may breach confidentiality.
Besides issues of authority or controlled access, there can be questions of practicality and dynamics of the place, organisation or group.
Questions that can be asked are:
Whether the research involves individuals participating in their own right and/or in a representative or official capacity (there is a difference)
What type and/or level of authority or permission do you need to conduct the research? Is it 'gatekeeper access' only (where you are only asking permission to access people or resources)? Or 'organisational consent' (where representative or official organisational views or positions are being sought)? Or both gatekeeper and organisational permissions?
Do you need to get Swinburne or other ethics clearance first for the research proposals before obtaining other types of permission or consent? Ordinarily the proposals for recruitment need ethics clearance prior to obtaining the permissions to recruit or involve other parties.
People are increasingly concerned about email use and privacy. Questions that arise include: "how did the researcher get my contact details?" or "my email address was sent without my permission" or "I wish to register a complaint against the disclosure of my private email address to others without my permission".
Some of the following issues need consideration:
How the email address has been or will be obtained and used (it may be problematic for contact details to be made available to researchers without consent of those whose emails are being disclosed/used)
Under whose auspices are individuals being contacted (as part of an organisational database or a private database)?
Ordinarily the owner/controller of the database of email addresses should contact the prospective participants, rather than the researchers.
Should you make contact or communicate by individual or bulk mail-out? If by bulk mail-out, the ‘BCC’ option should be used to contact people.
Careful use of language to recruit or involve people in the research is important — this usually involves reassuring people how they have been targeted for inclusion in the proposed research.
Note: For security and privacy reasons, Swinburne students are advised not to use their standard Swinburne student email address (which includes their ID number) outside of Swinburne, including for research purposes. An external email address should also not ordinarily be used for Swinburne purposes as these addresses/accounts are not under Swinburne control. (An exception could possibly be a researcher undertaking research under the auspices of public sector organisations such as a hospital or university that is subject to the same regulatory regimes as Swinburne, but this should not simply be assumed.)
Consent and consent waivers (covert observation, deception or non-disclosure)
A good discussion on this matter is provided in Chapter 3.1.23 to 3.1.39 of the National Statement on Ethical Conduct in Human Research (2007) updated 2018. Previous guidelines issued by the Office of the Victorian Privacy Commissioner identified the following essential elements of consent:
an individual having the capacity to consent (information regarding obtaining consent from persons with impaired capacity can be found on the NHMRC website)
their consent is voluntary
consent must be informed
consent must be specific
consent must be current.
Most research projects will involve consent being established or demonstrated through a carefully composed consent information (or plain language) statement and the signing of a related consent form. Further information on the use of such consent instruments can be found in the following documents:
These are also located in the 'Help' section of ERM (under 'Templates').
The ‘ideal’ consent information statement for the participant would be clear, economical and informative. Depending on the research, there may need to be different consent instruments per participant type. Obtaining and establishing consent is a significant agreement of trust and an important way to show respect for participants. Due care is needed both in the procedures to be followed and in the documentation to be used.
There may be circumstances where variation to informed consent may be justified and this should not simply be assumed. See Chapter 2.2 and Chapter 2.3 of the National Statement on Ethical Conduct in Human Research (2007) updated 2018 for general requirements for consent and qualifying or waiving conditions for consent.
Where active concealment or planned deception is involved or there is exposure of illegal activity, only SUHREC can review and approve the application (not a SUHREC sub-committee). Likewise, SUHREC review is needed where a waiver of consent for research using personal information in medical research or personal health information is requested. In some cases, Statutory Guidelines apply with respect to consent waivers for accessing, using or disclosing identifiable information and the Research Ethics Officer should be contacted for further information. Where a public interest determination is required, SUHREC review and approval would be needed. Under applicable guidelines or regulations, SUHREC may have to account for and report on its decision to approve the consent waivers proposed.
In the case of deception, concealment, withholding of information for consent purposes or application for consent waiver, a sufficient justifiable case is needed for the ethical review. Sufficient debriefing procedures and information should be considered to complete the picture; in some cases, the option to withdraw consent or participation should be offered to the participant affected. The possibility of upset, anger, distress or diminished self-esteem on the part of a participant should not be discounted and care is needed in the event of an adverse incident or experience. The impact on a researcher or 'confederate' administering deception should also be considered in putting forward proposals for deception.
This is no small matter as informed consent is a key way to show respect to those participating or whose information is being used in research. (Please note: information = data = records.)
Firstly, have a look at our Data Management FAQs for information on data collection and retainment. Legal and/or ethical criteria that would permit consent waivers are outlined in the applicable statutory or other guidelines. Swinburne’s Privacy Statement and guidelines also pertain. To the extent that a Human Research Ethics Committee (HREC) can permit consent waiver usually depends on the following:
Is the information “personal/health/sensitive information” as defined by privacy legislation?
Is the proposed collection, use or disclosure permitted or forbidden by any law?
What are the applicable Australian (APPs) or Victorian Health/Information (VHPP/VIPP) or other Privacy Principles?
Is the proposed collection, use or disclosure ruled out by the existing consents or permissions? Can this be ethically changed or overturned?
Is the proposed collection, use or disclosure consistent with the existing purpose/research? How so?
Whose interests are at play? Who benefits by the proposed research?
Is the proposed use against the interests of those whose information is being collected, used and/or disclosed? Who is doing the collecting or using or disclosing?
Can a test of impracticability be passed? How so?
If applicable, is the proposed use substantially in the public interest? How so?
What other benefits would justify the collection, use or disclosure now being proposed?
Applicable statutory or regulatory standards or guidelines include:
Guidelines under Section 95 of the Privacy Act 1988 (Cth) and flowchart to determine applicability
Guidelines approved under Section 95A of the Privacy Act 1988 (Cth) and applicability flowchart
Health Records Act (Vic) Statutory Guidelines on Research issued for the purposes of Health Privacy Principles 1.1 (e) (iii) & 2.2 (g) (iii)
Privacy and Data Protection Act 2014 (Vic)
'Opt out' consent needs careful consideration as to what is meant. You should first consider why you should obtain opt-in consent for what is proposed.
'Opt out' consent is given some definition in Chapter 2.3 of the National Statement on Ethical Conduct in Human Research (2007) updated 2018: "The opt-out approach is a method used in recruitment of participants where information is provided to the potential participant regards the research and their involvement and their participation is presumed unless they take action to decline to participate." Note that timely, relevant and understandable information is still needed that would enable an individual to opt out.
Many elements need to be considered if an 'opt out' consent proposal is either legally and/or ethically acceptable. You need to take careful note of what is outlined in Chapter 2.3 of the National Statement regarding qualifying or waiving conditions for consent.
Note: Bear in mind that there are or may be legal constraints with regards to any opt out consent, such as application of guidelines issued under privacy legislation.
Research involving children or young people under 18 years of age
Researchers involved in research with children or young people who are under 18 years old will require a Working With Children Check (WWCC). See Swinburne's Child Safety page for more information.
At Swinburne, this research may require full SUHREC review, especially where:
the children or young people who are under 18 years old are considered vulnerable
researchers have one-to-one contact with children or young people who are under 18 years old
researchers have contact with children or young people who are under 18 years old with or without appropriate adult supervision
only the consent of children or young people who are under 18 years old is being requested.
The minimum standards for research with children or young people who are under 18 years old are outlined in Chapter 4.2 of the National Statement on Ethical Conduct in Human Research (2007) updated 2018.
For research that recruits students via their schools, if this is a government or Catholic school, 'in principle' permission to involve the school must be obtained before approaching school authorities, unless otherwise explicitly allowed. You can apply concurrently for ethics approval and for permission to involve schools.
See this webpage for more information on involving schools in research.
Research involving students, colleagues or subordinates
A number of issues present in these contexts including 'professional distance', bias, power relationships, power analysis, anonymity/confidentiality, coercion and conflict of interest. Careful attention is needed with what is being proposed and how.
It may not actually be the case that, for example, there is a conflict of interest but there could be a potential for it or this can be perceived to be the case. Where conflict of interest arises, the project or researcher interests need to be disclosed and how the situation is to be managed should be reasonably plain to all concerned. Swinburne’s Conflict of Interest Policy should be consulted and adhered to where appropriate.
Research involving people in close, dependent or unequal relationships can be said to involve power at some level or type and proposals for voluntary informed consent need careful thought. If it is not necessary to involve people in dependent or unequal relationships, then the alternative should be considered, especially if the research is not or is more than low risk; convenient or accidental sampling may not be sufficient in some contexts.
How the situation has been clarified and weighed up needs to be shown. Conducting research on a small close sample is evidently different to a wider and much larger sample. Sometimes prospective participants may need to be especially reassured about there being no consequences to whether they do or do not agree to participate, or that if they first agree to participate they can still withdraw without any consequences or question.
For further discussion, see Chapter 4.3 of the National Statement on Ethical Conduct in Human Research (2007) updated 2018.
Research with specific participant groups
Chapter 4.7 of National Statement on Ethical Conduct in Human Research (2007) updated 2018. includes a focus on research involving Indigenous participants or topics.
Although the National Statement is the major ethics reference source for much social science research, researchers working with Aboriginal and Torres Strait Islander Peoples and communities also need to consult the following specialist guidelines:
- Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders (2018)
- Keeping research on track II (NHMRC 2018)
- Australian Institute of Aboriginal and Torres Strait Islander Studies (AIATSIS) published its Code of Ethics for Aboriginal and Torres Strait Islander Research (the AIATSIS Code) in 2020 and a guide to Applying The AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research (2020).
Researchers need to show appropriate consultation with Aboriginal and Torres Strait Islander Peoples and communities who are to be involved in the research. The research proposals need to show sensitivity to cultural and other contextual issues and values, especially what would be considered important to those who are to participate. Please also note that the ethics committee will seek extra-committee input from a panel of experienced Indigenous researchers to ensure the respect and values outlined in the Codes are reflected in the ethics application.
In support of Swinburne’s Reconciliation Action Plan, all Swinburne staff named in an application being submitted to Swinburne’s Human Research Ethics Committee need to complete cultural competency training provided by the Victorian Koorie Heritage Trust. This training is supported by the University and is ideally completed by all researchers on the project and prior to submitting an application so as not to hold up the ethics process. Provision is made in the ethics application form to attach confirmation that this training has been completed.
The Islamic Council of Victoria has published guidelines for Muslim community and University Research Partnerships.
Swinburne staff and students who intend to conduct research with the Muslim community are encouraged to familiarise themselves with these guidelines and incorporate the recommendations into their ethics applications and research protocols.
Conducting research online, on the internet or social networking sites
You need to show that care has been paid to what is proposed. Conducting surveys online or using networking sites and blogs raise ethical and other issues that need to be identified and addressed.
The issues can include:
awareness of terms and conditions for using or accessing the sites
awareness of what can legally, reasonably or ethically be considered public or private — what is publicly accessible is not the same as being able to use what is publicly available in any which way
awareness of risk of loss of privacy or confidentiality — given the questions/answers and participant sample, it may be possible to work out the identity of someone despite anonymity
awareness of who does or can access information communicated or held (besides the researcher and/or the participant, a system administrator of the hosting or back-up system may be able to or can and may access the same information — it would be incorrect then to claim or declare complete confidentiality and that only the researchers have access)
consideration as to what the appropriate level of security settings should be for administering a survey given the software package being used — how this can be done to minimise or prevent monitoring by unauthorised parties, and what you should disclose to participants
attending to participant access or user friendliness — would a participant have to log in to complete a questionnaire or can someone simply access the questionnaire via a URL? Would the information given make sense to all participants?
awareness that remotely completing the survey in some overseas jurisdictions may be in breach of local laws or regulations — if you are not reasonably certain of the situation, it may then be advisable explicitly to alert prospective persons outside of Australia to any local restrictions on participating in research being conducted from Australia/Swinburne
being aware that some questions put in the anonymous survey can be confronting or highly sensitive and may not allow the project to be classified as low impact/risk
being aware that what you are proposing can be considered covert observation (sometimes termed ‘lurking’) or deception
whether some of the particular questions or survey measures you are using are relevant or even necessary given the project aims and methods
understanding what information you are collecting and retaining, in what form it will be held and where, as well as to what extent is the information identifiable either directly or indirectly and who will have or can have access to it
in some cases, safety and security of the researcher may be also an issue depending on what is being researched and how — some may target a researcher for ‘lurking’ on the internet or using information without consent.
Regarding recruitment, include the following information in your application:
A list of the sites to be used
A description of whether recruitment will be passive and/or active — if using active recruitment, please provide a description of how potential participants will be identified and approached, and how their privacy will be maintained.
Evidence of compliance with applicable Commonwealth and State/Territory laws.
Evidence that the proposed strategy respects all relevant ethical norms.
If recruiting via online networks of current or potential study participants, an explanation of the approach.
Outline a communication plan for social media activities among enrolled participants.
For more information on ethical issues in using social media for research, refer to:
Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations [PDF 346KB]
Note: The IRB (Institutional Review Board) is the American equivalent of a HREC (Human Research Ethics Committee)
As per other forms of human research, please be mindful of how your research may affect or impact upon others.
As a Swinburne researcher or research trainee, you are still bound by minimum applicable standards and guidelines for conducting human research. There is also the question of researcher health and safety, as well as applicable legal, professional and/or ethical requirements that have to be met before, during and after the research. The requirements can vary significantly.
Here are a few circumstances that may need to be considered for research conducted overseas.
Is there an Australian Government prohibition or travel alert warning in relation to a particular country, region or jurisdiction?
If there is a warning or even prohibition, Swinburne may not cover the proposed researcher or research. If there is a travel ban, the Research Higher Degrees Committee may not permit a student researcher to undertake the research in the location.
Is there a mandatory ethical review system in the overseas system for the type of research you are proposing to conduct?
For example, if you are proposing to conduct health(-related) research in New Zealand, you may have to obtain ethics clearance via the NZ government health ethics committee system.
Is there a special permit or visa needed to conduct the proposed research in another country?
It may be problematic or even illegal to conduct scientific work or research in a particular country using a tourist or business visa. The research or researcher may also need to arrange for a sponsoring local researcher or research institution before, during or after the research.
In the case of a student/trainee or junior researcher undertaking research overseas, there may be a supervisory requirement or recommendation particularly if a researcher or participant is at risk.
In addition, please check whether there are any health requirements that must be complied with in the country where you are to perform research.
Haven't found the answer you're looking for?
Reach out to the Research Ethics, Integrity and Biosafety team by emailing firstname.lastname@example.org and we'll help answer any questions.