Human Research Ethics (HRE), evolved in response to some of the appalling medical 'experiments' of the 20th century and was designed to protect participants involved in medical research. It has since expanded from its original narrow focus on medical research to cover social science research – and is now expanding still further to include research fields such as the visual arts, music and journalism.
You can find an excellent summary of the evolution of HRE in Australia on the NHMRC's website.
HRE is guided in Australia by the 'National Statement on Ethical Conduct in Human Research' 2007 – and a very easy-to-use html version of this document.
The National Statement is the required set of guidelines for all research ethics applications. Its recommendations guide the activities of all HRECs in Australia – whether they be based at a university, a hospital, a government agency, a local council, or a not-for-profit organisation – the HRE rules you are asked to follow at UTAS are based on these national guidelines.
Research Integrity, by contrast, is what many people think of as 'ethical researching', and this name was adopted because the term 'research ethics' was already being used by the National Statement (and the equivalent animal research ethics codes).
The term 'research integrity' in Australia refers to a set of rules (codified in the NHMRC's 'Australian Code for Responsible Conduct in Research'), which cover a variety of research activities: management of research data, supervision of research trainees, publication/dissemination of research findings, authorship, peer review, conflict of interest & collaborative research across institutions.
It is worth nothing that some of the research integrity requirements (most notably management of research data, peer review and conflict of interest) are incorporated into the HRE application forms and need to be addressed by those seeking HRE approval.
Yes indeed! We really love to talk to applicants and answer questions, because it's so much easier to solve problems before applications are submitted than to have to send them back for changes (especially if those changes mean you need to get your application re-signed!).
So please do contact us – we're very approachable and there are many ways we can help to make your application better.
No – this is a misunderstanding. There is an assignment relating to Human Research Ethics in XGR501 (the first unit of the Graduate Certificate in Research) but this is a requirement of the GCR and is not – in any way at all! – related to the requirements of either of the two HRECs @ UTAS. You should discuss XGR501 assignment requirements with the Academic Coordinator of the Graduate Certificate in Research.
In order to complete an ethics application, you need to have already fully prepared your research project . This means you will need to be sure about: what you want to do; when you need to do it; who you would ideally like to use as your participants; why these are the best/most suitable participants for this project (and whether they are vulnerable in any way); what sort of data you will be collecting (especially whether your participants will be identifiable as a result); where/how/how long you plan to store your data (and what you will do with the data after that); and whether there are any risks/benefits associated with this project.
Generally speaking, most research students will not be able to answer these questions until after they have completed their candidature confirmation process. So our 'rule of thumb' is to suggest that you wait until your candidature is confirmed before you submit your ethics application. If there is some (very good) reason why you have to submit your ethics application before completing candidature, then please make sure you work with your supervisor to get everything right. If not, you will be wasting time for everyone: your supervisor, the HREC and you yourself
Applicants often seem to believe they are not permitted to contact the Chair and/or the Executive Office of the relevant HREC prior to submitting their application – but nothing could be further from the truth! We would MUCH prefer to answer questions in advance of submission than have to send an application back for revision!
And, while applicants may not begin to ask questions of their participants before the project has been approved, it is acceptable (and may well be prudent) to check with stakeholders and participant groups concerning the suitability of recruitment advertisements and/or PICFs (Participant Information and Consent Forms). In other words, ensuring your stakeholder groups are happy with the documents you plan to submit to the HREC makes lots of sense – otherwise, you're going to waste everyone's time …
A good example of when this sort of contact would make sense is in the case of a project where the actual participants will be people with minimal literacy levels who are being contacted by, say, a charity or social welfare organisation. Checking with that sponsor to see if they are happy with the wording of the PICFs can save weeks of revisions and new Amendment applications
HRECs are required, by the National Statement, to ensure all applications meet the requirement for 'research merit and integrity'. In Section1, the National Statement says, quite unequivocally: "Unless proposed research has merit, and the researchers who are to carry out the research have integrity, the involvement of human participants in the research cannot be ethically justifiable".
This very clear message is, however, later made rather less clear by Section 1.2, which says: "Where prior peer review has judged that a project has research merit, the question of its research merit is no longer subject to the judgement of those ethically reviewing the research".
So HRECs are really being asked to ensure that the applications they review have been effectively peer reviewed for academic merit and integrity prior to reaching the HREC itself.
After a number of previous attempts to ensure applicants provided sufficient information about their peer review processes, the SSHREC has now resolved this potential confusion by modifying the full application form to ask specific questions relating to peer review (changes to the forms are the major reason why we ask applicants to ensure they download the latest version of the form from the Integrity & Ethics website each time they submit an application):
- Section 4 (Research Merit – (b) Peer Review): for staff projects, we have a set of very explicit questions relating to peer review which we need all applicants to complete.
- Section 4 (Research Merit – (a) School Approval): In the case of HDR student applications, however, the Committee needs assurance that each research project has been, inter alia, subjected to a public presentation with the opportunity for questions about methodology, participant selection, etc. So what we're looking for is something along the lines of: "this project was reviewed by [researcher/s names and/or titles] and/or was presented to [X number of researchers and other HDR students] and [the following methodological or practical issues] were revised in response to their suggestions". This gives us confidence the HDR candidate and his/her supervisors have taken advice and strengthened the project as a consequence. The HREC can then forget all about what the NS calls 'research merit and integrity' issues and get on with our core job, which is evaluating the ethics issues.
Both the full (in Section 5) and the minimal risk (in Section 15) application forms ask whether your project also needs approval from other HRECs (and also if it needs approval from other Institutions / Departments).
There are several situations where applicants might need approval from one (or more) additional HRECs :
- Australian Defence HREC: we have been notified that "Defence's organisational policies require that all research conducted by, or on, Defence personnel and/or utilising Defence resources is to be reviewed and where appropriate, provided ethical clearance by ADHREC … Additionally … members of the Australian Defence Force are considered as people in dependent or unequal relationships. As this is a complicated ethical and institutional area, Defence requires submission of research involving Defence personnel to be considered by ADHREC". All applications involving serving ADF members must therefore have ADHREC approval prior to submission to the SSHREC.
- Other HRECs: if your project includes investigators from other Australian universities, hospitals or government agencies it is very likely you will also need approval from the relevant HREC covering that institution. In keeping with NS 5.3 (Minimising duplication of ethical review) there is usually a fast-track approvals process in these situations – UTAS, for example, uses what is called the 'Prior Approval' form which provides out-of-session review for applications already having approval from another Australian HREC.
- Overseas HRE approval: many other countries already have formal HRE approvals processes and NS 4.8.4 requires applicants to identify and comply with such processes.
All research is subject to potential conflicts of interest – but these can be subtler and harder to identify in the social sciences and researchers may actually be unaware of inherent conflicts of interest between their workplace / research activities.
NS 5.4 discusses a range of potential conflicts of interest – pointing out that:
- This 'may compromise the research process itself and/or the institutional processes governing research; and may lead researchers or institutions to base decisions about the research on factors outside the research requirements ' (p.89).
- Just as with coercion, perception of conflict of interest can be as problematic as its actual existence.
Researchers are expected to notify the HREC of real / perceived conflicts of interest (NS 5.2.10) – although failure to do so is often simply the result of lack of awareness of the problem on the part of the researcher. NS 5.4.6 states that a researcher who discloses such a conflict may 'remain involved in the research only if the review body is satisfied that the conflict can be managed without its nature being disclosed ' (p.90).
The major difference between publishing research data online vs. in an exhibition or in any other physical environment is that online material is never truly deleted (there's always something stored somewhere). So the best way to ensure your participants are providing informed consent is to tell them about this and ask if they're still willing for you to upload their [data / images / whatever] despite this risk.
Many researchers who are thinking about online presentation ask their participants if they are willing to have their data formally archived at UTAS – but this is somewhat misleading as such an option will probably give participants the incorrect belief their data will all be destroyed after five years – and you're not going to be able to guarantee this with online data.
I would suggest, instead, that you tell your prospective participants online media is likely to be long-lived and that agreement to have their information uploaded means it may well be available online for longer than the normal five years' research duration (and possibly forever). Consent to such an arrangement would be genuinely informed consent – and would not only be more ethical, but would also ensure you do not receive complaints in the future from people who ticked 'no' to the archive box, only to discover their data were still accessible many years later.
The National Statement does not require that all research undertaken with overseas participants be reviewed by the full HREC – rather, it reminds investigators that research involving overseas participants may require additional care; and/or "may … demand conduct that is in tension with the ethical values of this National Statement" (p.73).
Ch. 4.8 of the National Statement covers the issues involved in overseas research in considerable detail and, if you are at all unsure, you should read these 2 pages carefully.
To simplify life for researchers who believe their project is essentially low risk, however, Section 6 'Review of Ethical Considerations' of the SSHREC minimal risk application form asks researchers to answer 'yes' or 'no' to the question: "Does your research specifically target any of the following groups of people: People in other countries"
If the answer is 'yes', we then ask investigators to provide a justification for why their project remains minimal risk research. This is generally quite straightforward (e.g. "I will be interviewing professional "X"s on matters relating specifically to their profession and which do not pose any risk to their professional or social life") but it's important that we are able to document this assurance.
Leaving aside the human research ethics risks, overseas travel needs to be in accordance with the UTAS Travel Policy. Clause 3.5.1 of the policy requires that: Travel must comply with any conditions regarding DFAT warning levels or other safety considerations.
The travel must also be authorised in accordance with the Delegation Policy and Schedule of Travel Delegations (PDF 39.2KB) as per the policy.
The management of overseas travel is not a part of the SSHREC's responsibility – and we have no desire whatever to take ownership of reviewing travel risk assessments! – but we do need researchers travelling to any country with a DFAT level 3 warning or above to state explicitly that they will abide by the UTAS Travel Policy (and Schedule of Travel Delegations).
Section 7 (Funding): having ticked 'not funded' you still need to explain who will take responsibility for any expenses which might arise. Of course, there might not be any expenses, but the Committee is still required to ask for a 'responsible person/group'.
Microsoft Office 'tick boxes' are a worry for many people – but, in fact, they're actually quite easy to fill in:
- double-click on the box and an option box will appear over the top of your text;
- click the 'checked' button; and then
- click 'OK'
The options box will disappear and the text box you are working with will now be filled with a rather neat X.
As you can see, there are options you can also select in the options box – but none of these is necessary. The simplest solution is just to choose 'checked'.
Recruitment of Participants (Minimal Risk – Section 8; Full Risk – Section 10): 'classic' snowball sampling, where you ask the people you do know to give you the contact details of other people who might be suitable so you can phone/email them directly, is now a breach of personal privacy under the Tasmanian PIP Act (2004). But don't despair – there is a (slightly longer) alternative which will still allow you to set a snowball rolling. You simply confirm in this section that participants will not be asked to provide you with the personal contact details of other potential participants, but will instead pass along information about the study to other people who can then contact you.
Data Identifiability (Minimal Risk – Section 9; Full Risk – Section 11): it's possible the way this section is described has confused you – we are seeking to learn what sort of raw data you will be collecting, rather than asking you about the form your data will take once transformed by your analysis processes. If you know who your participants are (e.g. you are emailing them to arrange a workshop or focus group, or asking them questions which identify them) your data cannot be non-identifiable but must rather be, at least, re-identifiable.
This is not necessarily a problem – we simply need you to explain how you will be protecting the identities of your participants (perhaps by using a table in which real names will be matched with pseudonyms which will thereafter be the only form in which identities are referenced?). If you are taking the 'table' approach, you will need to explain that only the researchers will ever see the linked names/pseudonyms and that these will be stored separately from the rest of your data.
If your participants are identifiable (i.e. if people reading the thesis or article in which you publish your findings can identify your participants, despite your attempts to hide their identities behind pseudonyms) then you must also offer these participants the opportunity to review their transcripts and, ideally, anything in the thesis/articles which might identify them. Participants who consent willingly to be identified, provided they can check what's said about them before it's published, are giving truly informed consent.
An extremely important consideration in the ethical conduct of a human research project is the degree to which the voluntary and informed consent of participants is obtained. The design of a project must provide an appropriate mechanism to provide such consent, and an application for ethical clearance for a project must identify and address any potential issues that might have an impact upon the voluntary and informed nature of the consent obtained from participants.
In the case of students, what the National Statement calls their 'unequal relationship' with teaching staff (see Ch. 4.3 of the NS) means that three types of issues can directly affect the nature of their consent:
- Perceived impact upon grades or service – Where a student perceives their decision about participation might affect either the grades they receive or their ability to access services, this may result in significant coercive pressure. Such considerations can be especially acute where the researcher is also their tutor or lecturer (where the data collection is not anonymous, so their participatory status will be known to the researcher); and / or where the data reflects upon their learning or attitudes towards the unit being taught;
- Perceived impact upon relationship with tutor or lecturer – Where a student perceives that their decision about participation might affect the way their tutor or lecturer perceives them, this may result in significant coercive pressure. Such considerations can be especially acute where the students' participatory status will be known.
- Peer pressure – "Open" recruitment or data collection which occurs in front of an entire cohort of potential participants (e.g. a tutorial session) can result in peer pressure that may have a coercive impact upon potential participants.
The recruitment and informed consent materials must stress the voluntary nature of participation and explain very clearly indeed that participation will not have any impact on grades or a student's ability to access services. If the researcher is also a tutor or lecturer of the potential participants, it would be preferable that they remain unaware of who participates. Where this is not practicable, the researcher must go to great lengths to assure potential participants that they are under no pressure to participate.
It is generally preferable not to conduct recruitment or data collection in a situation where an entire cohort of potential participants are "put on the spot" and asked to participate in a research project. Potential participants should be given time and space to consider their participation, especially where there are potential coercive pressures upon their decision.
If your survey is intended to be anonymous it should ideally remain anonymous for all respondents, even those who choose to participate in later stages of this study (otherwise you will find it very difficult to treat their survey responses in exactly the same way you treat the other, anonymous responses – human nature being what it is).
The easiest way to keep your survey anonymous but still invite participants to identify themselves for later research tasks is to remove the link between names and questionnaires for those respondents who are willing to participate in Phase II. Rather than including the space for contact details on the questionnaire itself, you can simply provide a link to a second survey questionnaire where respondents can include their details. This is very easy to do with all the major online survey providers – and can be handled by including a separate, detachable sheet with your hard-copy questionnaire, if you're (also) using paper-based documents. This will still give you all the details you need, without the requirement to link the two survey forms together, thus ensuring anonymity for all respondents
I'd recommend avoiding the use of user ids completely, because even asking participants to make use of their user id to access the survey environment means that you will know who has considered taking the survey. Since it is unlikely you will obtain a 100% response in any case (I don't think I've ever come across a 100% response survey!), I would recommend that you accept you won't know who has completed the questionnaire and, instead, simply ask participants to go to a particular URL and take the survey – this is the approach used by most researchers. It's especially important if you're planning to ask 'tricky' and/or very personal questions!
Quite apart from the ethical benefits this approach provides, you will find that more respondents are willing to participate in your survey if they can be assured of genuine anonymity …
This question relates to researcher safety. The University is not only responsible for the welfare of research participants, but for the welfare of the researchers themselves – and when researchers plan to gather data in locations where they may be at risk, the University is held responsible by its insurers for any accidents which might occur. Researchers who plan to gather data in such locations are therefore asked to provide evidence that they (and their supervisors, in the case of a student project) have developed a suitable safety protocol, e.g. that the researcher will carry his/her mobile phone at all times, will notify a supervisor or colleague (or some other suitable person) when data gathering is about to commence and will call or text when the data gathering visit is safely completed
We ask for such a protocol in the case where a researcher plans to gather data in participants' homes, as well. While this may seem over-zealous on the part of the HREC, 80% of accidents occur in homes and, while the University is responsible for researchers' safety, it is better to be overly cautious than not cautious enough …
Monitoring (Minimal Risk – Section 12; Full Risk – Section 19): this relates to what the National Statement describes as "the process of verifying that the conduct of research conforms to the approved proposal" and is the responsibility of the institution which approves the project (in your case, the SSHREC). You need to explain both:
- how the project team itself will be monitoring the project; and
- how you will handle reporting to the SSHREC.
Essentially, we are asking you to explain how you will: ensure you do what you have promised to do; provide annual reports; and will immediately notify the HREC of any adverse incidents.
We are asking you to confirm that you will: ensure the project conforms with what has been approved; provide annual reports; and will immediately notify the HREC of any adverse incidents. But if you're having difficulty working out how to express this in your application form, here are some helpful examples which have been slightly amended from previous applications:
Example 1: The chief investigator, <name>, will monitor the conduct and progress of the project. The researchers will conform to HREC reporting requirements as indicated in NS 5.5; will prepare a final report; and will immediately notify the HREC of any adverse events.
Example 2: This project will be monitored in accordance with Section 5.5 of the National Statement. Annual and final reports will be submitted to HREC Tasmania when due, as will reports of any adverse events associated with this study. Regular meetings will be held between the student investigator, the chief investigator and the co-investigator.
Example 3: This research project will be conducted in compliance with the approved proposal and any conditions attached to this. Unexpected occurrences, events, outcomes or disruptions that may arise during the research will be reported immediately by the CI to the Integrity and Ethics division of the University of Tasmania. On completion of the research <date> a final report will be submitted to the Integrity and Ethics division of the University of Tasmania.
Data Storage (Minimal Risk – Section 13; Full Risk – Section 21): most people seem to feel comfortable explaining where they plan to store their hard copy data, but often forget to clarify how electronic data will be stored. Essentially, you need to explain that these data will be stored on password-protected UTAS computers (or, more probably, on your School's network drive).
Data Storage (Minimal Risk – Section 13; Full Risk – Section 21): both the Australian Code for the Responsible Conduct of Research, as well as the brand-new UTAS Research Data Management Policy and procedures, require that electronic research data be held in secure, regularly backed-up storage within the School in which the candidate is enrolled. In view of the advent of UTAS cloud storage, however, this rather narrow definition has been extended to include the MySite facilities (see http://www.utas.edu.au/service-desk/mysite which explains how to link to a student cloud storage site from a UTAS laptop or desktop PC. A successful application will generally include one of these more secure and reliable PhD student storage facilities for your electronic data.
Here is a quick list of do's and don'ts for research data storage:
- Physical data must be stored in a secure, locked facility within your organisational unit – not at home, though you can store a working copy of your data at home
- Electronic data must be stored on a secure, regularly backed-up University network drive or computer within your organisational unit; and not
- On your personal PC at home (though you can store a working copy of your data there)
- On Dropbox or some other commercial cloud storage facility (not secure!)
- On a USB stick – whether stored on campus, or carried around in your pocket / handbag for convenience (again, not secure!) …
- Data Retention: once the active phase of your project is complete, you must ensure data are moved to a secure repository until time to delete (especially important for Honours projects, where the student may well leave the University at the very start of the 5 year retention period).
- Data Archiving: if you wish to offer your participants the option of having their data archived, this must be explained in both the application form and the PICFs (Participant Information and Consent Forms).
- Data Destruction: if you plan to destroy your data after the five-year minimum retention period, both physical and electronic data must be destroyed and in a manner which leaves no traces behind (i.e. electronic files cannot simply be 'deleted', as this merely removes the index listing to a file on a hard disk but leaves the file itself intact).
This is a fairly common situation – many people find that data they have gathered as part of their teaching or workplace activities are sufficiently interesting to justify publishing in an academic venue. The issue is how to obtain approval to re-use these gathered data in the new way.
There are two possible approaches to applying for approval to use such data:
- If the data were gathered from identifiable sources (e.g. via interview) the simplest approach is to submit a minimal risk application, with an Information Sheet and Consent Form explaining your plans and asking the original participants for their approval to use the already-collected data in the new way;
- If, however, the data are non-identifiable, you will need to request a 'waiver of consent' under Section 2.3.10 of the National Statement.
The National Statement handles waiver of consent in Section 2.3.10 by means of a series of questions the researcher/s need to answer explicitly in their HRE application. If you include this list of questions and your responses in a suitable part of the minimal risk application form (e.g. Section 9 - Recruitment of Participants or Section 15 – Consent Form) that, together with an explanation of your situation, is normally sufficient.
"Before deciding to waive the requirement for consent ... an HREC ... must be satisfied that:
a) involvement in the research carries no more than low risk ... to participants
b) the benefits from the research justify any risks of harm associated with not seeking consent
c) it is impracticable to obtain consent (e.g. due to the quantity, age or accessibility of records)
d) there is no known or likely reason for thinking that participants would not have consented if they had been asked
e) there is sufficient protection of their privacy
f) there is an adequate plan to protect the confidentiality of data
g) in case the results have significance for the participants' welfare there is, here practicable, a plan for making information arising from the research available to them (e.g. via a website)
h) the possibility of commercial exploitation of derivatives of the data ... will not deprive the participants of any financial benefits to which they would be entitled
i) the waiver is not prohibited by State, federal or international law"
Both the Australian Code for the Responsible Conduct of Research and the UTAS Management of Research Data Policy highlight the importance of retaining data where this is ethically possible, asking researchers to consider the potential value of their data for further research. The Australian National Data Service (ANDS) identifies 5 reasons for researchers to consider sharing their data:
- It encourages scientific enquiry and promotes innovation
- It provides credit to the researcher as a research output in its own right by increasing the impact of the research
- It leads to new collaborations between data users and data creators
- It maximises transparency and accountability
- It reduces the cost of duplicating data collection
Data sharing is most commonly handled by making data available for use by other researchers where there is no ethical, privacy or confidentiality objection to doing so; and disseminating a full account of their research as widely as possible. ANDS provides a list of 4 requirements for ethical and legal data sharing:
- Protecting people's identities by anonymising data whenever this is needed
- Including provision for data sharing at the time you obtain informed consent, i.e. telling your participants you would like to make your data more widely available and asking them if they consent
- Ensuring access to the shared data is controlled when necessary, e.g. shared data are often stored on externally or institutionally-managed, secure databases
- Making use of appropriate end-user licences where this is needed
If you think the data you are collecting as part of your research may be useful to other researchers, or to the general public, consider whether you can ethically share these data once your project is complete. More information on data sharing is available from www.ands.org.au.
Many researchers (especially those engaged in qualitative research) find it difficult to answer this question (which is found in Section 10 of the full application form). The following examples, adapted from previous ethics applications– both high and minimal risk – and completely anonymised (or, in one case, written by me entirely) may provide assistance. But note that you will need to chase up the references yourself (I haven't included them here). And the text included within <> symbols will need to be replaced with an equivalent phrase relating to your project …
Example 1 (justifying a relatively small sample of interviewees):Many authors on qualitative research methods agree that saturation is achieved at a comparatively low level (e.g. Guest et al., 2006), and samples generally do not need to be greater than 60 participants (Charmaz, 2006) with 15 as the smallest acceptable sample (adapted from Guest et al., 2006). Other researchers have provided similar guidelines for qualitative sample size, e.g.
- Charmaz (2006, p.114) suggests that "25 [participants are] adequate for smaller projects"
- Ritchie et al. (2003, p.84) note that qualitative samples often "lie under 50"; and
- Green & Thorogood (2009, p.120) state that "the experience of most qualitative researchers is that in interview studies little that is 'new' comes out of transcripts after you have interviewed 20 or so people".
Example 2 (Justifying a statistically analysable sample):A minimum of 30 participants would be required for the statistical analysis of the data to yield meaningful results. We would hope to recruit more than 100 participants, so that the sample size can be compared to those found in previous studies from different <equivalent strata> (e.g. Park & Chitiyo, 2011).
Example 3 (Justifying a questionnaire or other qualitative tool):To ensure a valid assessment of the proposed <instrument> it is estimated that the validation of the full <tool> will require a minimum of 200 participants (Tabachnick & Fidell, 2001). Statisticians recommend that in designing questionnaires and/or assessments at least 5-10 participants per variable are required – with an ideal sample size of 300 participants (Comrey & Lee, 1992; Field, 2005).
Example 4 (Justifying focus group size):Focus group size is not a well-researched topic: Carlsen & Glenton (2011) reviewed 220 papers published in 117 journals reporting on focus groups and found only 37 provided a justification for their group size, with a variety of relatively unscientific justifications – pragmatic approaches to focus group size justification being the most frequent. Gill, Stewart, Treasure & Chadwick (2008) cite the views of Stewart & Shamdasani (1990) and advise over-recruiting – and potentially managing a rather larger than optimal group – rather than under-recruiting, to avoid having to cancel the session or having an unsatisfactory discussion. These authors believe the optimum size for a focus group is 6-8 participants (excluding researchers), but suggest a workable range of 3-14 participants. Bloor, Frankland, Thomas & Robson (2001) note that small groups run the risk of limited discussion, while large groups can be chaotic, hard to manage for the facilitator and frustrating for participants who feel they get insufficient opportunities to speak.
Example 5 (Justifying experimental group size):We are proposing to collect 23 participants in each group based on a power analysis conducted in GPower3. [Unfortunately, we could not obtain an effect size from previous studies examining the <topic under research> as no previous studies have examined this question, however] we have based this power analysis on an effect size of differences in <dependent factor> in <experimental group> vs. <control group> (effect size .2: Peri et al., 2000) using a standardized <experimental task>. To obtain a power of .8, with an alpha value of .05, using a repeated measures mixed factorial design with 3 groups and 4 measurements (response to the CS+ and CS-, prior to and after the <experimental> phase), GPower reports that we need a total sample size of 69 (approximately 23 in each group).
If you are a student researcher, it's best to commence the section "Who is conducting the project?" in your Information Sheet by making it clear this research project is being conducted in partial fulfilment of a <degree name> for <student name> and is being supervised by <supervisor name/s and affiliation details>. Remember to include all your supervisors.
Yes. On each of the information sheets include the ethics committee contact details as follows:
This study has been approved by the Tasmanian Social Sciences Human Research Ethics Committee. If you have concerns or complaints about the conduct of this study, please contact the Executive Officer of the HREC (Tasmania) Network on (03) 6226 6254 or email firstname.lastname@example.org. The Executive Officer is the person nominated to receive complaints from research participants. Please quote ethics reference number H_____.
Ethical issues in accessing individually identifiable data from YouTube videos, Facebook pages and Twitter feeds
Researchers in many fields of study are becoming increasingly aware of the rich sources information publicly accessible from popular social media venues such as YouTube, Facebook, Twitter, Pinterest (and many others). But is this information truly 'public', in the sense that it is fair game for access, analysis and academic discussion?
There are, in fact, two quite separate issues involved here, from a Human Research Ethics point of view:
Is ethics approval needed at all?
Firstly, do these researchers require ethics approval at all? The answer to this question is quite straightforward – yes, you do! Chapter 5.1 of the National Statement clarifies the only circumstances in which ethical approval is NOT needed:
Research that can be exempted from review
5.1.22 Institutions may choose to exempt from ethical review research that:
a. is negligible risk research (as defined in paragraph 2.1.7); and
b. involves the use of existing collections of data or records that contain only non-identifiable data about human beings.
5.1.23 Institutions must recognise that in deciding to exempt research from ethical review, they are determining that the research meets the requirements of this National Statement and is ethically acceptable.
So pulling videos from YouTube, or personal data and opinions from Facebook or Twitter does not fall within the area of exempted research, as this information is unquestionably identifiable. So the answer to the first question is quite simple – researchers in this situation do need to submit an ethics application.
How ethical is such research?
Now for the more complex question: is obtaining data in this manner ethical or, to put it a different way, does such research involve any risk for the researcher's unsuspecting 'participants'? Here, the answer is anything BUT straightforward, but it's possible to tease out the issues and clarify what
An excellent article by Michael Zimmer, entitled ''But the data is already public'': on the ethics of research in Facebook" (Ethics Inf Technol (2010) 12:313-325) summarises the issues thus (my numbering):
"… the emerging challenges of engaging in research within online social network settings. These include (1) challenges to the traditional nature of consent, (2) properly identifying and respecting expectations of privacy on social network sites, (3) developing sufficient strategies for data anonymisation prior to the public release of personal data, and (4) the relative expertise of institutional review boards ...
… future researchers must gain a better understanding of the contextual nature of privacy in these spheres (Nissenbaum 1998, 2004, 2009), recognizing that just because personal information is made available in some fashion on a social network, does not mean it is fair game for capture and release to all (see, generally, Stutzman 2006; Zimmer 2006; McGeveran 2007; boyd 2008a).
Similarly, the notion of what constitutes ''consent'' within the context of divulging personal information in social networking spaces must be further explored, especially in light of this contextual understanding of norms of information flow within specific spheres" (p.323).
The issues, then, according to Zimmer, include both privacy and consent. The author also identifies (p. 322 – my added numbering) "… four salient dimensions of privacy violations, as organized by Smith et al. (1996) and based on thorough review of privacy literature: (1) the amount of personal information collected, (2) improper access to personal information, (3) unauthorized secondary use of personal information, and (4) errors in personal information" .
While it is highly unlikely any reputable researcher would deliberately engage in any of these errors, not everyone is sufficiently familiar with the implications of social media to consider just how the people uploading YouTube videos/Facebook pages/Twitter feeds would feel about discovering they were unknowingly the subject of a research project. It is, after all, only too easy to upload an opinion on social media which gives entirely the wrong impression to its readers – adding a layer of academic analysis to social content may well make things worse …
Further useful advice can be found in "Ethical Issues in Qualitative Research on Internet Communities" by Gunther Eysenbach and James E. Till (BMJ. 2001 Nov 10; 323(7321): 1103–1105: Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC59687/). This helpful article makes the important point that: "Researchers and institutional review boards must primarily consider whether research is intrusive and has potential for harm, whether the venue is perceived as "private" or "public" space, how confidentiality can be protected, and whether and how informed consent should be obtained".
Putting the ethics application together
So, if it isn't possible to obtain 'informed consent' from those posting information on social media (and that is often the case), how do researchers go about putting a sound ethics application to use such material together? The authors of the material may well be 'Internet celebrities' and thus difficult to contact; or they may be hiding behind pseudonyms or anonymous links; or the researchers may need to access many, many sites to gain cross-sectional data; or …
The issues to be considered are risk and consent:
- Risk: will the use of the author's social media content create what Ch. 2.1 of the National Statement defines as 'risk', i.e. the potential harm which may occur + the likely severity of that harm. This chapter talks about risk in some detail, identifying many different types of possible risk (physical, psychological, social, economic, legal, etc.) and researchers hoping to access social media will generally spend some time considering just what risks (if any) are likely to occur as a consequence of their study
- Consent: since, by definition, the author/s of the material will not be consenting to its use, researchers will need to apply for a 'waiver of consent'. NS 2.3.10 outlines the circumstances in which waiver of consent is ethically acceptable (it is also worth noting the provisions of NS 2.3.12 which requires all HRECs to report back to the NHMRC on all projects where waiver of consent was approved).
Researchers at the University of Tasmania can download the latest version of the low risk application form, where they will see that Section 14 now specifically caters for waiver of consent:
Chapter 2.2 of the National Statement provides guidelines on the requirements for consent in human research. With few exceptions, participation must be voluntary and based on sufficient information and an adequate understanding of the proposed research. In general, an information sheet and consent form is used to provide potential participants with necessary information about study and to obtain their consent should they choose to participate.
Does the research involve:
- An opt-out approach (Section 2.3.5 of the National Statement). Please complete section 14A below.
- A waiver of consent (National Statement 2.3.10). Please complete 14B below.
- Obtaining consent from participants prior to their involvement or to the use of their data. Please complete section 14C below.