Swinburne Human Research - Some FAQs, issues and help notes
A. Obtaining and managing ethics clearance
1. Why do I need to get ethics clearance?
Swinburne and its researchers (like researchers of institutions getting public funding) are committed to and bound by applicable principles, guidelines, standards and regulations. Foremost is the Australian Code for the Responsible Conduct of Research (2007) (March 2014) which describes a strong research culture as demonstrating:
- honesty and integrity
- respect for human research participants, animals and the environment
- good stewardship of public resources used to conduct research
- appropriate acknowledgment of the role of others in research
- responsible communication of research results
Putting forward research proposals for independent review (whether peer and/or ethical review), which 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. Of course, appropriate commitment and conduct on the part of researchers of integrity complete the picture.
2. How do I apply to get ethics clearance?
Once you have worked out that your proposed research requires ethical review and approval before commencement, including actively recruiting for participants, you should go to the research ethics webpages and check for:
- the type and level of ethical review, the correct forms and templates to be used
- the procedures applicable and
- the deadlines for submission.
Generally, you would need to use the prescribed ethics clearance application form and submit an original signed copy plus the minimum copies required given the type and level of review. There are some exceptions that apply, eg, where you have to get ethics clearance from another ethics committee, are conducting a clinical trial or an intervention that involves substances or devices, etc.
Please note a sessional Swinburne staff member cannot be listed as the Chief Investigator on an ethics application.
3. How often does the ethics committee meet?
Given existing resources and member availability, committee/subcommittee meetings are scheduled as follows. SUHREC meets 9-10 times per year every 5-6 weeks to review 100 or so proposals. SUHREC Subcommittees meet about 30+ times a year, 2-4 weeks apart depending on the time of year, to review around 200 applications
4. When do I find out about my application and how long does it take to get ethics clearance?
It takes about 3 weeks or so to hear about the outcome of an ethics clearance application from the time of the published deadline; or about a week or so 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 which 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 a delegate and not await the next scheduled meeting to be processed. Once the delegate is satisfied as to the researcher responses, clearance will be issued. For the most part, approval by a delegate should not take more than a few days.
However, where a project has been sent back for resubmission, this usually will be subject to published meeting and application cycles unless otherwise advised.
5. Why has my ethics clearance application been rejected?
Where a project protocol has not been approved as submitted, it is usually due to significant lack of detail, the information given is incoherent or quite unclear, the research questions or methods are apparently irrelevant or unnecessary, 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. Those tasked to conduct ethical review must themselves be clear as to what they are reviewing and the grounds for approval.
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 particular 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.
6. What does it mean to get ethics clearance/approval?
Importantly, the ethical review body or reviewers are part of the ethical review and monitoring equation. Significantly, in the National Statement on Ethical Conduct in Human Research (2007),
- “the researcher should demonstrate that the research has merit and reflects the values of justice, beneficence, and respect for humans (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 (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. So, eg: 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 simply also recruit participants with Type B Condition. If you are only going to conduct anonymous surveys with implied consent, you cannot simply also conduct interviews unless you get timely prior ethics clearance. And so on.
Important: you need to 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.
7. Can I modify or add to my approved research protocol, documents/instruments or procedures?
Yes you can.
As mentioned above re what is covered when ethics clearance is issued, clearance is for what is submitted and approved; what is not submitted or approved is not covered.
If you need to modify or add to the approved protocol for good reason, you need to apply to do so in time using the prescribed or preferred format for which information is given on the human research ethics webpages.
A request to modify or add to the existing protocol typically will include:
- a summary on what the project is about and what is approved
- a brief relevant report on progress to date
- what is now proposed to occur (a modification, a variation or an addition)
- why the change or addition
- how participants will be affected or individuals or groups impacted (if applicable)
- what are the ethical issues relating to the addition or change and how has this been considered
- attached additional, updated or revised research, publicity and consent instruments
- Please note project extensions can also be requested via Swinburne Research Analytics [staff login]. To access the Ethics section, log into SRA -> My Profile -> Ethics. There are help materials in our wiki [staff login] if you require assistance.
(A rare exception: you can change or modify an approved protocol without prior clearance where you have to do so in an emergency to prevent or minimise harm. In this instance, you still need to notify the Swinburne Research Ethics Office as soon as possible thereafter to ensure continuing ethics clearance. Depending on the circumstances, ethics clearance and the research may need to be suspended or even withdrawn.)
8. What do I need to consider if I want to add new personnel or students to an approved project?
What do I need to consider if I want to add new personnel or students to an approved project, particularly with respect to consent documents?
Adding new staff or students to a project requires completion of a Swinburne 'modification request' form which must be approved by the Swinburne Ethics Office prior to that person(s) joining the project. If data collection is still ongoing, the name 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 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 addition of the new personnel.
B. Exempt or non-exempt research
9. What human research activity can be exempted from formal ethical review?
Specifically, in line with 5.1.22 of the National Statement on Ethical Conduct in Human Research (2007) (May 2015) research will be exempted if it is
- negligible risk (ie, the only foreseeable impact on human beings would be negligible at worst, with no risk of discomfort or harm), and it
- 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 though 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 (which may change), what may also be exempted is activity such as Quality Assurance (QA) or Quality Improvement (QI) projects, some limited consultancies, class training exercises within the classroom or course setting, observational work placements as part of coursework, etc, 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; and
- the activity is solely for internal Swinburne purposes (especially for QA/QI projects); and/or
- 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; and
- 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, opinions in published material
- unsolicited but privately communicated comment
Further information is available from the Research Ethics Co-ordinator.
10. I am only conducting an on-line anonymous survey, do I need ethics clearance?
Yes. According to the National Statement on Ethical Conduct in Human Research (2007)(May 2015), this would be human research needing ethical review and approval in line with the National Statement at some level. But see also other items on using email for recruitment, consent and/or participation arrangements or research using the internet, blogs, social networking sites.
11. I am only carrying out an evaluation of my (service provision/teaching style/etc)?
Fine, but if it’s being done for a purpose other than for internal Swinburne operational or management purposes only, then ethical review is usually needed. If you anticipate presenting or publishing a paper using data relating to people involved in a program, then, yes, you will need to apply for ethics clearance at the appropriate level.
C. Multi-site and transferred research
12. What happens with multi-site or previously cleared research?
- I have received ethics clearance from and conducted research with or at XYZ University/Hospital, can I transfer the research and clearance?
- I will be conducting research with or at XYZ University/Hospital and I need to get or I have 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 being 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 particular 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.
But Swinburne, as with a number of other organisations, an attempt is made to minimise duplication of ethical or other review. All things being equal, Swinburne expedited ethical review may be available if the ethical review already undertaken accords with Australian research ethics standards.
To apply for expedited review at Swinburne, please follow these instructions.
13. Do I need to obtain Swinburne ethics clearance if I am an adjunct/affiliate/visitor?
The short simple answer would be yes in that any research conducted under Swinburne auspices must meet applicable standards and guidelines. As regards human research, the requirements of the National Statement on Ethical Conduct in Human Research (2007 and updates) 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.
Important to bear in mind is that, unless otherwise authorised, the Swinburne ethical review can only cover what is being undertaken under Swinburne auspices. To the extent 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.
14. Do I need to obtain Swinburne ethics clearance if I'm recruiting/using Swinburne staff/students?
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, 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, perhaps also making available a copy of the information being used to obtain consent.
Realistically, though, you should consider whether the demands on Swinburne resources would be justified.
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.
D. Ethical issues/Risk assessment and management
15. There are no ethical issues relating to my research?
Given what guidelines 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) (May 2015):
- research merit and integrity,
- beneficence (or non-maleficence),
- justice and
- respect. To some extent, respect for human beings 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 at least according to the above values. Other ethical and professional perspectives or approaches, consistent with these values, should also be considered.
16.There are no risks relating to my research?
The National Statement on Ethical Conduct in Human Research (2007) (May 2015) 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, eg, a few minutes to complete an anonymous survey) to low (foreseeable as discomfort, eg, being asked some sensitive questions that would not lead to distress) to not low (risk of distress or harm).
Within this context, “research is ethically acceptable only when its potential benefits justify any risks involved”. Risks thus need to be identified, assessed and prevented (if possible), 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.
17. I think my research is low risk because?
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) (May 2015) and/or by Swinburne, this should be fine.
In this regard, you need to be clear about the criteria set out in the 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 which may require higher level ethical review. Swinburne checklists drawn up for this purposes should be carefully checked.
Also bear in mind other perspectives: you might think from your perspective that the proposed activity is unexceptional or without risk, but others may not 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 on-line 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.
18. I am conducting research involving Swinburne neuroimaging or confining equipment (MRI, MEG, etc)
In the case of Swinburne neuroimaging equipment, such as MRI or MEG, you would need to obtain prior endorsement from the Neuroimaging Committee 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, eg, working with infected 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 Swinburne 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.
19. Can I conduct legally sensitive research?
In line with applicable parts of the National Statement on Ethical Conduct in Human Research (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.
Thus 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, etc.
But 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:
- Whether you are 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?
- Do you have the expertise to conduct the research either as regards 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 which is either not sensitive or less sensitive?
- Do the project anticipated or potential benefits justify any of the risks involved?
- Are your methods carefully thought through, especially with regard 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 as against being enforcers of law (or enforcers of morals for that matter).
- Researchers may be wearing more than ‘one hat’ or ‘a researcher’s hat’, eg, the researcher being both a researcher and a treating health professional, etc.
- Whilst confidentiality should at all times be respected, 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 (eg, child abuse) and failure to do so is of itself 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?
20. What's the approval process if I'm conducting research that involves Defence or Veterans?
What's the approval process if I'm conducting research that involves the Department of Defence or Department of Veterans' Affairs, including the use of Defence personnel as participants?
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).
E. Data management (collection, use, disclosure, retention and disposal)
21. How long do I keep research data or materials?
Data needs to be securely retained and then securely disposed of or destroyed when no longer needed. How long the data or material need to be retained depends on the type of research or data. The minimum standard is set out in Section 2 of the Australian Code for the Responsible Conduct of Research (2007) (March 2014). Basically, research data should be retained for as long as there need for referral to the data, eg, to justify or defend the research, or to satisfy legislative or some other standard. Some minimum standards as follows:
- For most research, the minimum recommended standard is 5 years from the date of any outcome based on the data.
- For short term projects which 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 7 years after last health-related usage or service provision, or 5 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 5 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.
See also information on data management.
22. Can I share or allow access to research data?
Data access or sharing is encouraged in Section 2 of the Australian Code for the Responsible Conduct of Research (2007) (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 but with due regard to applicable or relevant ethical, legal, privacy or confidentiality standards. Quite 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.
So for data still 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 data already collected, the situation warrants close, careful attention to ensure professional, ethical and legal requirements or standards are met. You need firstly 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 with regard to the new purpose?
Put very simply, if the new sufficiently detailed proposal demonstrates
- 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 and
- 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 FAQ/Help Note G.31 below re consent waiver.
23. I am using de-identified / anonymous information?
Clear thinking and language are usually needed as regards 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 or 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 breached, even though the information collected, used or disclosed is merely anonymous.
Chapter 3.2 of the National Statement on Ethical Conduct in Human Research (2007)(May 2015) has some good discussion on type of information access, use or retention.
24. I am using information that is publicly available?
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. In this regard, some thought is needed with some questions or concerns as below instanced. One matter to appreciate is the concern out there 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's 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" as defined by and is then subject to applicable Federal or State Privacy legislation or professional/ethical standards based on the Privacy legislation. The applicable standards here are variously referred to: "Information Privacy Principles (IPPs)", "National Privacy Principles (NPPs)", "Victorian Information Privacy Principles (VIPPs)", "Health Privacy Principles (HPPs)", etc, depending on the legislation or jurisdiction.
Using the telephone directory to select and contact participants can also raise a question or two. Whilst it is not here being stated that one cannot use the telephone directory for research purposes, some care is needed to minimise or prevent unnecessary concern on the part of individuals affected. A concern can be on who’s 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 or 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 particular cases, it may also mean notifying the individuals concerned with regard to a right to opt out of the database.
But 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. Swinburne researcher attention is also drawn to 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. For a start, there may be explicit conditions of access or use. Can the proposed use be seen as covert observation or 'lurking'? (see above re internet research methods).
25. What should be considered in regard to publishing?
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.
26. Are there any ethical issues in accessing data via Freedom of Information requests?
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 consider carefully 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 or external FoI expert (e.g. Kornel Koffsovitz, tel: 9214 5515 or email Kkoffsovitz@swin.edu.au) before approaching the Ethics Office. Consent waiver requirements of the National Statement, and other parts of the National Statement depending on the nature of the data, may also need to be taken into consideration when obtaining data this way.
F. Incentives / Recruitment
27. I wish to use incentives or payments or a prize draw to conduct my research?
The National Statement on Ethical Conduct in Human Research (2007) (May 2015) 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 as such 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, again 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 will names be drawn for the prize
- how winners will be notified in writing and when (if they have won a prize and the value of the prize is above $1000, further notification requirements are likely to apply)
- any contingency for non-collection/-acceptance of a prize should also be considered
- 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. (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 beware 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.)
28. I am conducting research with a workplace/club/association/community centre/professional body?
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 more or less 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.
29. I am using email to recruit and conduct my research?
Fine and what is involved needs some careful attention. People are increasingly concerned about email use and privacy, eg, "how did the researcher get my contact details?" or "my email address was sent without my permission", "I wish to register a complaint against the disclosure of my private email address to others without my permission", etc. So at least some of the following need thinking through and addressing:
- 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 facility should be used to contact people.
- Careful use of language to recruit or involve people in the research is important – it is usually reassuring to let people know how they have been targeted for inclusion in the proposed research.
NB Swinburne students are advised not to use their standard Swinburne student email address (which includes their real ID number) outside of Swinburne, including for research purposes. And an external email address should 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.)
G. Consent / Consent waivers (covert observation, deception or non-disclosure)
30. What are the elements of consent? How do I establish consent?
A good discussion on this matter is provided in Chapter 2.3 of the National Statement. Previous guidelines issued by the then 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)
- That consent is voluntary
- Consent must be informed
- Consent must be specific and
- Consent must be current.
Most research projects will involve consent being established or demonstrated by the use of 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:
- Guide to Informed Consent Instruments [DOCX 46KB]
- Guide to Informed Consent Instruments (Sarawak) [DOCX 41KB]
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, an important way to show respect for participants and due care is needed both in the procedures to be followed and in the documentation to be used.
31. I'm conducting research involving consent waivers/deception/covert observation/disclosure issues
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)(May 2015) for, respectively, general requirements for consent and qualifying or waiving conditions for consent.
Where active concealment or planned deception is involved or exposure of illegal activity, only SUHREC can review and approve the application (not a SUHREC Subcommittee). 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.
32. I'm not obtaining/can't obtain consent to use data being/already collected; is this acceptable?
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. (Nb, for this FAQ: information = data = records.)
Firstly, have a look at FAQ E. 22 re the questions with regard to data collected or retained. 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 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)
33. Can I use ‘opt out’ consent for my research?
'Opt out' consent needs careful consideration as to what is meant. As well, 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. "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.
A number of 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 re qualifying or waiving conditions for consent.
Caution: bear in mind that there are or may be legal constraints with regard to any opt out consent, such as application of Guidelines issued under Privacy legislation.
H. Research involving children or young people who are under 18 years old
34. I am conducting research with children or young people who are under 18 years old?
Researchers involved in research with children or young people who are under 18 years old may require a Working With Children Check (WWCC). See Swinburne's Child Safety page for more information.
At Swinburne, research involving children or young people who are under 18 years old ordinarily requires 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; and where
- 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)(May 2015).
Research recruiting students via their schools: With schools under the authority of Government or Catholic Education Offices, 'in principle' permission to involve the schools must be obtained before approaching school authorities unless otherwise explicitly allowed. You can apply concurrently for ethics approval and for permission to involve schools.
I. Research involving students, colleagues or subordinates
35. I am conducting research with my students/colleagues/subordinates/family & friends etc.?
A number of issues present in these contexts including 'professional distance', bias, power relationships, power analysis, anonymity/confidentiality, coercion, and conflict of interest and thus 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 at the very least 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 thinking through. 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 no consequences to whether they do or do not agree to participate or 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) (May 2015).
J. Research with specific participant groups
36. I am conducting research with Aboriginal and/or Torres Strait Islander Australians?
The minimum standard is that briefly outlined in Chapter 4.7 of the National Statement on Ethical Conduct in Human Research (2007) (May 2015). Additional guidelines need to be applied, depending on whether the research is either health-related or not.
If health research is involved, then Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research (2003) apply. [Please note: some allowance should be made for the fact that these Guidelines are being updated as the 2003 edition correlates with the earlier 1999 edition of the National Statement.]
For other research involving Aboriginal and Torres Islander Australians, the AIATSIS Guidelines for Ethical Research in Australian Indigenous Studies (2011) should be consulted.
Whether health-related or not, researchers would need to show appropriate consultation with those Aboriginal and Torres Strait Islander Peoples 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 may have to obtain confidential extra-committee input into the ethical review process, whether the participants live in remote locations or in urban settings.
In the case of Indigenous, Aboriginal or First Nations Peoples overseas, researchers should be alert to applicable laws, processes, standards, and guidelines and demonstrate familiarity with these in their ethics clearance applications.
37. I am conducting research with or about members of the Muslim community - what issues should I be aware of?
The Islamic Council of Victoria has published guidelines for Muslim community - 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/research protocols.
K. Conducting research on line, on the internet or social networking sites
38. What should I consider when submitting an application that involves conducting research online or via social networking sites?
You need to show that care has been paid to what is proposed. Conducting surveys on line or using networking sites, blogs, etc, 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 (eg, 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; what should you disclose to participants?;
- attending to participant access or user-friendliness – would a participant have to log in in order to complete a questionnaire or can someone simply access the questionnaire via url? Would the information being 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;
- be aware that some or more actual 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 to use are relevant or even necessary given the project aims and methods;
- what information are you collecting and retaining? in what form will it be held and where? to what extent is the information identifiable either directly or indirectly? who will have or can 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.
In regard to 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 utilising 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, please read the following article: Barbara E. Bierer (2017) 'Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations', The American Journal of Bioethics, 17:3, 3-14, DOI: 10.1080/15265161.2016.1276644 [PDF, 346KB] N.B. IRB (Institutional Review Board) is the American equivalent of a HREC (Human Research Ethics Committee) and this document [PDF, 760KB].
As per other forms of human research, please be mindful of how your research may affect or impact upon others.
L. Overseas research
39. I am doing my research overseas in a country which does/does not have 'ethics'?
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. Plus there may be applicable legal, professional, and/or ethical requirements that have to be met before, during and after the research. The requirements can vary significantly from research or researcher circumstance to circumstance, from jurisdiction to jurisdiction.
A few items that may need to be considered for research conducted overseas, as follows.
- 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?
Eg, 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.
40. I am conducting research in developing countries
41. I am conducting research in Asia/the Pacific
Please see information on ethics approval processes in Asia/the Pacific.