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SoTL Human Research Ethics Resource Manual Booklet 04 Recruitment and consent in SoTL research Page 1 of 38 v01 | May 2016 Contents 01.00 About this booklet 02.00 National guidelines 03.00 Examples of recruitment in the context SoTL research 04.00 Approaches to consent 05.00 Ethics review 06.00 Sources of advice 07.00 References 08.00 Acknowledgments 1.0 About this booklet This booklet of the SoTL Human Research Ethics Resource Manual ( SoTL Manual ) provides an overview of useful and ethically appropriate recruitment and consent strategies for scholarship of teaching and learning (SoTL) research explores the ethical principle of respect for persons and its role in the ethics review of projects discusses practical strategies for the design and conduct of SoTL research. This booklet references but does not repeat content from the other booklets of the SoTL Manual . The guidance can help SoTL researchers avoid some of the more common reasons for delays and frustrations associated with the ethics review of SoTL research, refine the ethical design of the research, and ensure the conduct of the research is ethically justifiable. It should not be approached as a set of rules to be applied without reflection, but rather as a prompt to support your practice. Back to contents 2.0 National guidelines Human research (see Booklet 1 for a definition of this term) conducted under the auspices of an Australian institution that receives research funding from

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Page 1: 1.0 About this booklet - Australasian Human …€¦ · Web viewBooklet 0 4 Recruitment and consent in SoTL research Page 1 of 29 v01 | May 2016 Booklet 04 Recruitment and consent

SoTL Human Research Ethics Resource ManualBooklet 04 Recruitment and consent in SoTL research

Page 1 of 27 v01 | May 2016

Contents01.00 About this booklet02.00 National guidelines03.00 Examples of recruitment in the context SoTL research04.00 Approaches to consent05.00 Ethics review06.00 Sources of advice07.00 References08.00 Acknowledgments

1.0 About this bookletThis booklet of the SoTL Human Research Ethics Resource Manual ( SoTL Manual )

provides an overview of useful and ethically appropriate recruitment and consent strategies for scholarship of teaching and learning (SoTL) research

explores the ethical principle of respect for persons and its role in the ethics review of projects

discusses practical strategies for the design and conduct of SoTL research.

This booklet references but does not repeat content from the other booklets of the SoTL Manual .

The guidance can help SoTL researchers avoid some of the more common reasons for delays and frustrations associated with the ethics review of SoTL research, refine the ethical design of the research, and ensure the conduct of the research is ethically justifiable.

It should not be approached as a set of rules to be applied without reflection, but rather as a prompt to support your practice.

Back to contents

2.0 National guidelinesHuman research (see Booklet 1 for a definition of this term) conducted under the auspices of an Australian institution that receives research funding from the National Health and Medical Research Council (NHMRC) or Australian Research Council (ARC)1 must adhere to the National Statement on Ethical Conduct in Human Research (2007). The National Statement was issued by the National Health and Medical Research Council,

1 Research should be considered as being under the auspices of an institution if any of the below statements apply to the project or fellowship:

the research activity/output will be claimed for internal/external purposes through the institution the work will be identified (e.g. to potential participants, sites and in any output) as being research of the institution there are contracts or agreements associated with the work that will describe it as being under the auspices of the

institution there are invoices or other payments associated with the work that will describe it as being under the auspices of the

institution the work is covered by the institution’s insurance/indemnity.

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the Australian Research Council and Universities Australia. The tone of some interactions between ethics reviewers and administrators with researchers in the humanities and the creative arts, as well as the social sciences can be described in terms of an ‘adversarial culture’ (Israel et al., in press). Researchers engaged in research in higher education can become enmeshed in this adversarial culture.

The booklets of this resource manual are intended to help SoTL researchers avoid, or at least mitigate, some of these problems or delays with the research ethics review process by showing, in their applications, that they are familiar with relevant ethical considerations.

It remains important for researchers to approach review feedback in a positive and reflective manner. The responsibility of ethics reviewers is to offer that advice in good faith in order to assist in the successful ethical design and conduct of research, enhance the degree to which people will be willing to participate, and potentially to add to the quality of the results.

Sections 1.10–1.13 of the National Statement discuss the core ethical principle of respect for persons. Central to this principle is the need to give ‘due scope, throughout the research process, to the capacity of human beings to make their own decisions’. Two of the practical research activities in which this principle can be applied to human research projects are recruiting participants (see 3.0) and obtaining consent (see 4.0).

Section 2.2 of the National Statement discusses general requirements for consent in human research. Across the sections of the National Statement considerable guidance is provided in respect to special issue-specific requirements for consent that may apply to some research designs, potential participant pools and contexts. Given the significance of the ethical considerations associated with the recruitment phase of a human research project, it is perhaps surprising that there is not a chapter of the National Statement devoted to recruitment. Nevertheless, there are frequent references to specific issues relating to recruitment that may apply to some projects.

An institution’s research ethics reviewers (e.g. the institution’s Human Research Ethics Committee) may not be conversant with the potential benefits and the practicalities of SoTL research. Consequently, it is vital that SoTL researchers have a clear understanding of:

the principle of respect for persons as it relates to their planned research

the available options with regard to practical and ethically valid recruitment and consent strategies for their funded research

how best to justify their selected approach in the application for ethics review.

This booklet provides practical advice with regard to these matters. See 5.0 of this booklet for more about ethics review.

Back to contents

3.0 Examples of recruitment in the context of SoTL researchThe recruitment of sufficient numbers of participants can be fundamental to the success of human research, including SoTL work. There are, however, key ethical considerations for recruitment strategies including:

respecting and appropriately safeguarding the privacy of potential participants

ensuring the recruitment strategy does not unduly pressure individuals to participate, or otherwise undermine voluntary participation

appropriately addressing any risks associated with the recruitment strategy (see Booklet 3 of this manual)

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Much SoTL research involves empirical investigation involving a cohort of students (see Inset One for an example). SoTL research can be embedded into a learning or assessment activity and so may appear to be a mandatory activity for all of the students. For example, Diamond and Reidpath (1992) reported finding a range of coercive practices being employed by many of the 37 accredited Australian psychology departments in the way that they recruited students to participant pools. Diamond and Reidpath found that:

Of [the 68% of] institutions using students as research subjects, 35% (8) penalised the students for nonparticipation. Four institutions lowered grades by 3% to 6% for nonparticipation, three required substitute work either in the form of an essay or a library assignment, and one university gave students a choice between a 3% decrease in grade or submitting an essay. (p. 104)

Given the costs associated with university study, the workload of students and the pressure to complete studies as quickly as possible, the arrangements discussed above might be considered to be coercive and of significance. In many cases, institutions will attempt to justify such arrangements on the basis that participating in research is a valuable learning experience for future professionals.

These issues of dependent relationships are often well apparent to researchers. Burman and Kleinsasser (2004), for example, recognised that the ‘power dynamics between teacher and student may make it difficult for a student to say “no” to participating in a project’ (p. 67). However, the National Statement does not permit2 mandatory participation in human research (see National Statement s2.2.1 ). This can represent a significant (but not insurmountable) challenge for the ethical design and conduct of SoTL research. This challenge and the practical strategies that have been used successfully in the past within SoTL (see below) may be unfamiliar to some members of a university’s Human Research Ethics Committee. A policy approach taken by some institutions to address this challenge is to ensure a separation between mandatory participation for academic/course evaluation purposes and use of data for research purposes. Where students are required to participate in at least one research project to receive course credit (as is often the case for first year psychology students), they must be offered a number of projects from which to select one. When considering such work, ethics reviewers are likely to have higher expectations that the benefits of such work will justify any risks and at least some of those benefits will flow to participants. At least one Australian university has attempted to minimise the coercive impact on students by stipulating that students must receive credit even if they withdraw part way through a project.

Failure to identify and discuss these predictable ethical considerations, and assess how they will be mitigated, could result in delays and problems with the ethics review of the work (see 5.0).

With regard to students as potential participants, researchers must reflect on the following matters, formulate appropriate strategies to address these matters, and provide a sound ethical justification with regard to:

whether researchers’ efforts to elicit participation could be seen by potential participants as coercive, manipulative or impairing of their ability to offer free and informed consent

whether academic staff involved in assessing work of students in this cohort will be aware of the participatory status of individual students

whether third parties will be aware of the participation status of individual students

whether there are risks or harms associated with the decision to participate, and/or be screened and included in or excluded from participation (see Booklet 3 of this resource manual)

how these matters will be explained to potential participants (see 4.0)

how these matters will be discussed in the application for ethics review (see 5.0).

2 In circumstances where a researcher is not able to seek the voluntary consent of potential participants they must seek HREC approval for the use of either the ‘opt-out’ approach or a waiver of the consent requirement (see NS2.3).

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MacLean and Poole (2010) argued that teachers who are also acting as researchers should therefore:

discuss their own role in the research and their positions of authority in the class as a potential conflict in that research. Engaging in ongoing dialogue with the students throughout the course about the research and how it is affecting the students’ educational experiences increases the students’ comfort with the research and allows them to continue their decisions to give ‘informed consent’ as truly informed participants. (p. 6)

Similar issues around coercion may arise for university staff who might be asked to participate in research, for example, if the researchers or their sponsors are in a more senior position in the university. Booklet 6 of this manual discusses some of the ethical challenges that can arise for SoTL research and possible strategies to mitigate their impact.

3.1 Does the situation warrant precautions?An important early question for SoTL researchers is the degree to which it is necessary to take precautions to ensure individuals can exercise a truly voluntary decision about their participation and/or their anonymity with regard to their participation. It may be the case that the absence of any risks or burdens for participants and the potential benefits of the work are such that any perceived pressure to participate might justifiably considered acceptable. See Inset One for an example of such a situation. Whether a situation (where individuals might perceive some pressure to participate) will be considered acceptable will depend upon whether there:

genuinely is no risk to or significant burdens on participants

are genuine benefits (e.g. potential contribution to the body of knowledge) for the work.

It is important that applicants for ethics review for such work show that they have recognised, considered and developed a strategy to address this issue and share these proposals on this matter.

See Booklet 2 of this manual for more about ethics review and Booklet 3 for more about risks and benefits in SoTL research.

Inset One – Midwifery researchers will be trialling with a large cohort of undergraduate students the use of a smartphone based app that is intended to assist the good study, reading and assignment writing behaviours of the students. Midway through the semester, a small subset of the students will be asked in class time to discuss whether they are finding the app useful, what problems or frustrations they have encountered, and what could be changed to improve upon the app. No personally identified data will be collected during the discussion. Instead, the researchers wish to identify whether there are any general issues to then be explored in a later online survey that will be sent to the wider student cohort. Even though the academics will tell the students that participation in the class discussion is voluntary and no identifying data will be collected, some students might perceive some pressure to participate. In such a situation, the researchers can look to respond to student fears, and quite justifiably argue that there are no risks associated with participation and that students can elect not to say anything during the discussion.

The ethics reviewers might still be concerned that non-participants will be identifiable by their silence. Ultimately, the reviewers are likely to consider what the risks are to the students and then make a decision based upon the specifics of the situation.

In their application for ethics review the researchers would needto acknowledge the potential impact of the unequal relationshipand articulate why the potential benefits justify this situation.

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3.2 Concealing participatory status from the assessing academic and the academic responsible for hiring and supervision of staffIn most cases it will be necessary (see 3.1) to take measures to ensure individuals can make a genuinely voluntary decision about their participation in a research project. A common strategy is to conceal the participatory status of individual students from the academic who will be assessing them. Concealing participatory status can:

enhance the degree to which students perceive they can genuinely make a voluntary decision (because the tutor/lecturer won’t know if the student elected to participate)

be an essential strategy to address the risks associated with a research project (because, in most cases, not even the researcher will know which individuals in the cohort elected to participate).

Sessional staff might be reluctant to take part if they feel the results of the research might have an impact on their professional standing or on future hiring decisions. See Inset Two for an example of a strategy to deal with these matters. The use of such a strategy should be explained in the application for ethics review (see 5.0) and to potential participants in the consent materials (see 4.0).

3.3 Concealing participatory status from peersIn some cases, peer pressure can undermine the voluntary nature of participation (e.g. an individual not wanting to be seen as the ‘odd one out’ because of her or his decision not to participate in a project). Such a concern may be especially significant where the reasons for the decision whether to participate relate to sensitive personal information (e.g. because of religious beliefs or sexual orientation).

There may also be risk associated with peers knowing an individual’s decision with regard to participating in a project.

See Inset Three for an example of such a situation and a strategy to address the issues. In some cases matters will be so serious that the researchers may decide recruitment will be timed and/or conducted so participatory status is completely masked (e.g. in the case of students, recruitment is conducted anonymously outside a tutorial/lecture; focus groups are not used).

Inset Three – A research project will use a survey to investigate the experiences of staff with regard to harassment at university. There are several reasons why a staff member might not want their peers to know if she participates (for example she might not want her peers to know she was previously badly bullied). It may also be that a tutor is currently being harassed by another academic and might genuinely worry that if he participates the harassment might intensify (if the other staff member concludes the details of the harassment have been divulged).

In such cases, potential participants might be advised to all take the survey booklets but return a blank booklet if they do not want to participate (thus masking their decision whether or not to participate). The potential sensitivity of the issues might be serious enough that the researchers decide to design a mechanism for the return of thesurvey booklets to further mask participation (e.g. a pre-paid return envelope or a web form).

Inset Two – A research team is interested in the extent to which students understand how to acknowledge material they locate online and the degree to which they have knowingly plagiarised text from online material (such as the use of an argument without proper attribution). Researchers will be investigating the views of tutors of their own topics and the current cohort of students. Consequently, the researchers are conscious that: 1) the students might conclude that their decision with regard to participation might impact upon the grade they will receive; 2) any self-disclosure of poor awareness or understanding might impact upon their grades; 3) any self-disclosure of plagiarism might result in very serious consequences (e.g. academic misconduct proceedings); and 4) any tutor might feel that students’ poor practice might be seen as reflecting poorly on the tutor.

Despite these issues, the researchers believe collecting accurate and honest data is important.

So, they decide to collect the data via a genuinely anonymous online survey. The recruitment and consent mechanisms and materials stress that participationis voluntary, emphasise that the survey is anonymous and that students will not be linked to their tutor, and explain that the researchers are seeking honest answers.

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In one-to-one interviews and other ‘in person’ activities it can be extremely important to ensure the location and timing of the activity means individuals cannot be observed or identified as participating. Similar precautions should be considered for email and web-based activities (e.g. avoiding the use of emails and social media invites that could be seen by peers).

Masking the participatory status of individuals from their peers might be combined with masking the participatory status from the assessing academic (see 3.2). The use of a third party might be required to achieve this (see 3.5).

3.4 Quarantining data until a later dateSometimes it may be impractical to conceal the participatory status of students and it may not be possible to collect data in a de-identified form. But there might remain a reasonable concern that students might perceive pressure to participate or worry that there might be risks if they do not participate in the form of souring their relationship with their tutor or negative impact on their grades.

In such situations, it might be possible to quarantine the data where data collection occurs but have the participatory status of students masked until after the assessment grades for the semester have been determined. This is often the approach taken by institutions to student evaluation of teaching surveys. See Inset Four for an example of this masking and quarantining.

The use of such a strategy must be carefully explained to potential participants to ensure participation is genuinely voluntary and there are no perceived risks.

3.5 Use of a third partyIn some cases, the strategies described at 3.2, 3.3 and 3.4 will not be appropriate or practicable. This is typically the case where data must be collected in an identified form, data needs to be collected and possibly analysed during the course of the semester, or the collection of data in group contexts (such as focus group sessions, observation of groups or group tasks) is required.

There may, however, be good reasons why it is still prudent to mask the participatory status of individuals from the assessing academic (see discussion at 3.4).

In such situations a viable alternative might be for a third party (such as another academic from the school, department or centre, or from another institution) to collect the data and provide it to the rest of the research team (including the assessing academic)

Inset Four – A research project will be looking at the effectiveness of an intervention program to assist first year science students who are at risk of withdrawing from their undergraduate degree program. Data collection will involve interviews with tutors, analysis of the reflective journal that all ‘at risk’ students complete and the students’ grades for the semester.

By ticking a box, students indicate their willingness for their journal to be used for research purposes. The researchers will blind the participatory status of students by not being able to see if the box has been ticked by the student until after the grades for the semester have been determined.

In this way, tutors, students (and the ethics reviewers) can beassured there will be no research analysis of the journals and grades until after the students have been informed of their results.

Inset Five – As part of an OLT-funded project, a deputy head of school wants to conduct focus groups with academics who have recently been appointed to their first permanent position to explore their commitment to the university’s new excellence in teaching initiative.

The researcher is concerned the staff might perceive some pressure to participate and that the information they will disclose might reflect poorly upon them. So the researcher arranges for a colleague from another school (who doesn’t know the staff) to facilitate the focus group.

The researcher is also conscious that the participants may not be entirely candid in sharing their views with her.

The colleague will take care to ensure that no one other than the staff attending the focus group will be aware of who has participated in the focus group.

The colleague will carefully de-identify the data before providing it to the deputy head of school. The recruitment and informed consentmaterials will explain this to potential participants and this will be reiterated at the start and end of the interviews.

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in a form where personal identifiers have been removed. See Inset Five for an example of the use of a third party.

The arrangements will need to be carefully explained to potential participants (e.g. in the recruitment and consent mechanism/materials).

3.6 Internal identificationIn the past when researchers and ethics reviewers have reflected on whether third parties would be able to identify individual participants (e.g. in the reporting of the results of the research), they have focused upon a ‘typical’ person in the community. However, it may be more useful to focus upon ‘internal identification’ where the reflection is whether peers and colleagues of the participants could recognise individuals and perhaps assign comments and circumstances to the identified individual (Tolich, 2004). In practice, such identification may be more problematic for participants and more likely to be a source of risk (e.g. humiliation and social harms within the peer group).

When reflecting upon the matters discussed in this section, researchers should consider both the broader potential identification of participants and the potential for internal identification. This should be discussed in the application for ethics review (see 5.0), recruitment (see 3.12) and consent materials (see 4.0).

In many cases there will be little a researcher can do about the possibility of internal identification other than to bring it to the attention of potential participants and perhaps include an additional consent step (see Inset Six) before the output of the research is disseminated. This extra consent step might restrict what can be reported in a research output but it might also increase the willingness of individuals to participate and lead to a more positive relationship between the researchers and participants.

3.7 Recruitment and riskAs per Section 2.1 of the National Statement , the risks of human research must always be justified by the potential benefits of the work.

Approaching people about participating in research can expose them to risk, regardless of whether they consent to participate. This can be a serious ethical concern that must be addressed by the design of SoTL research.

In many projects, the most effective strategies for addressing such risks are those that conceal the participatory status of individuals, see 3.2, 3.3, 3.4, 3.5 and 3.6 for commentary on this.

There can be other risks associated with the recruitment of individuals (such as possible emotional distress). See Inset Seven for an example and a strategy to address them.

Inset Six – A research project will collect anecdotal accounts from students about effective teams in a group assessment task, compared to accounts from poorly performing teams.

Even though accounts will be collected across several units, the researchers are conscious that students may well be able to identify teams and individuals by the phrasing of accounts and the details of experiences. Any such identification may be a source of perceived social risk and of concern to some participants.

For the most part the research analysis will be based upon thematic analysis of the provided accounts and aggregated data. However, they do intend to include illustrative statements from individual accounts. Despite the fact that individual students will not be named in the research outputs, the researchers decide to check back with individual participants with regard to any quoted accounts or details of individual situations that will appear in the research outputs. They also consider creating ‘synthetic’ composite statements that are fictional but are based on the real accounts.

In the application for ethics review and the informed consent materials, the researchers must carefully identify the potential for internal identification and their awareness that this may concern some potential participants. They must outline the intended strategy to reconfirm the consent of individuals and obtain permission for the use of the quotes or description of the situation. It should be made clear that students will be able to request changes to further de-identify them and the situation or that the circumstances can only be reported in very general terms.

Inset Seven – A research project will explore the reasons why students elect to study Law (including the extent to which a proportion of students have direct personal experience as a victim or perpetrator of crime) and the extent to which it might be useful to incorporate resilience building strategies early into undergraduate programs.

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It is an ethical responsibility of researchers to monitor the risks of their work and to take appropriate action if new or unexpected risks emerge or the risks are more significant than anticipated. The responsibilities of researchers are discussed throughout the National Statement. Many institutions have produced resource material to assist their researchers with these matters. SoTL researchers should check this resource material and seek advice (e.g. from a research ethics adviser) as appropriate.

Consult Booklet 3 of this resource manual for more about risks in SoTL research and Booklet 1 for more about the responsibilities of SoTL researchers.

3.8 Screening potential participantsDesigns for human research often use screening techniques as a component of the recruitment mechanism. Such techniques can be used to ensure the variables of interest are collected (e.g. first year university students who are the first person in their immediate family to go to university) and to exclude potentially confounding variables (e.g. persons studying their second degree and mature age students).

Because of the ethical principle of justice, it is generally considered inappropriate to exclude people on the basis of demographic factors (such as gender, age, disability, language competence, socioeconomic status, etc.) unless this is for genuine research reasons (see Inset Eight for an example of this).

Researchers should be conscious of justice considerations (such as whether the mechanism to select participants and access the anticipated benefits is fair).

Screening can also be used as part of the risk minimisation strategy for a project (e.g. excluding persons who are already receiving support from academic support or counselling services because of poor academic performance). See Booklet 3 of this manual for more about addressing risks in SoTL research.

It is good research practice to include in the outputs from a project a discussion about how the potential participant pool was screened, especially if this might represent a limitation of the results or reduce generalisability to a broader sample.

These matters should be identified, explained and justified in the application for ethics review (see 5.0). Researchers should also consider how they are explained to potential participants (see 4.0).

3.9 Recruitment of junior or sessional staffSpecial care should be taken where the potential participants are junior or sessional staff, especially if the researchers are senior. This is because junior staff might perceive some pressure to participate (e.g. to maintain good relations with the senior staff member, to be perceived as a ‘team player’). There may also be risks (regardless of whether they are actual or only perceived) related to their participation.

Inset Eight – The researchers are interested in the academic experiences of mature-aged students living with a visual or auditory disability and the degree to which their needs are being met by their university.

Consequently, it is necessary (and appropriate) to screen the potential pool on the basis of age and disability.

In addition to using the recruitment mechanism (e.g. a broadcast email sent by the DVC Academic and posters around the campus), the researcher will confirm via phone or email that potential participants meet the selection criteria.

The researchers may need to explain (or indeed modify) the screening criteria if an interested student is just outside of thespecified age range or if they are living with a different disability.

Inset Nine – A head of school is a member of a team looking at career mentoring for very early career academics. As a component of this OLT-funded work, the team will be surveying staff to explore the degree to which staff feel their needs are being met and the school is enabling their development as new academics.

The potential participants might worry that their decision with regard to participating and their comments (especially if critical of the school) might adversely affect their career or relationship with the head of school.

The researchers might decide the best way to ensure voluntary participation and obtain frank comments is to either make the survey anonymous or to conceal the participatory status of individuals from the head of school. This should be clearly explained in the informed consent materials (see 4.0) and the application for ethics review (see 5.0).

Inset Seven – A research project will explore the reasons why students elect to study Law (including the extent to which a proportion of students have direct personal experience as a victim or perpetrator of crime) and the extent to which it might be useful to incorporate resilience building strategies early into undergraduate programs.

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Such concerns can become even more acute if a researcher is the direct supervisor of the participant, or has significant standing in the discipline in which the participant is located, or is the head of the academic area in which the participant is located.

See Inset Nine for an example and commentary.

Sometimes the best strategy to mitigate risks is to conceal the participatory status of individuals. Another strategy is to ensure data or comments are stripped of identifiers at the earliest stage and cannot be linked to individuals. Such strategies may not always be practical. In such cases ethics reviewers (see 5.0) will expect the researchers to state clearly that participation is voluntary and that the decision of the staff members will have no impact upon their employment. They are also expected to explain how this will be achieved. Reviewers will also assess the degree to which any risks are justified by the anticipated benefits of the research. See 5.0 for more about ethics review and Booklet 3 of this manual for more about benefits and risks in SoTL research.

3.10 Recruitment and international studentsEnsuring voluntary participation of international students can be especially challenging because:

The culture of the students might incline them to show deference to teachers, instructors and other authority.

The cost and logistics of study might make international students want to complete their studies with the minimum of delay and so maintaining positive rapport with teaching staff may be especially important.

Familiarity with English (or the language of the recruitment mechanism) might undermine their understanding that participation is voluntary.

Some SoTL research involving international students may involve data gathering outside Australia.

Section 4.8 of the National Statement provides advice with regard to the ethical conduct of research outside of Australia and requires that research conducted overseas by researchers from Australian institutions must comply with the National Statement. Where there are additional ethical and regulatory requirements in the jurisdiction where the research is being conducted, it is possible both Australian and non-Australian requirements will apply, or some form of blending of the two sets of requirements. In some jurisdictions, there will be additional risks (to participants, the researchers, or others), special ethical considerations (e.g. in terms of the form of the consent mechanism that would be most appropriate), and practical considerations (e.g. related to language, literacy, access to communication technology, and the provision of contact information). Such matters will need to be thoughtfully addressed in the research design and discussed in the application for ethics review for the project.

Consequently, when working with international students, researchers should take extra care to ensure the potential participants understand participation is voluntary. Extra care should also be taken both with regard to the strategies to mitigate risks and how these are explained to potential participants.

See Inset Ten for one possible approach to the recruitment of international students.

Similar issues apply to research where potential participants are students at an institution in another country, especially if their host institution will be aware of the participatory status of individuals or the data from those students.

3.11 Recruitment and incentivesUnlike a reimbursement to cover the costs of participating (such as travel costs for

Inset Ten – A SoTL project will explore how students balance their studies with any concurrent employment and will investigate how family/carer responsibilities affect study. The researchers have decided to include the potentially different experiences and challenges facing international students studying in Australia and offshore.

The researchers are very conscious of the possibility the students might feel pressured to participate and interviewing the students individually might cause them anxiety. They identify several key international student markets and ensure that their research complies with relevant research ethics guidelines in those countries. They decide to restrict offshore participation to students from those jurisdictions.

The researchers liaise with the International Students Office (ISO) to recruit the students, to reinforce to the students that participation is voluntary and will not impact upon the services they receive, their data will be recorded anonymously, and that no one outside the ISO will know whether they participated.

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reaching the testing site), an incentive is a payment, an expression of gratitude or gift to encourage people to participate in a research project.

An incentive can be a valuable tool to maximise participation (e.g. participants receiving a voucher for a free pizza if they complete and submit a response to a survey); but such an incentive is not without its ethical challenges – such as the degree to which the level and nature of the incentive might be coercive or manipulative and prompt an individual to expose themselves to a risk he or she might have otherwise chosen to avoid.

The substantive ethical question may be contingent upon the characteristics of the potential participant pool, the seriousness of the risks, and the compelling appeal of the incentive.

Some institutions and research ethics committees interpret Section 2.2.10 of the National Statement to mean it is not ethical to offer potential participants an incentive to participate. Some other institutions allow incentives for research that involve no more than a low risk of harm but may specify maximum dollar values for incentives.

A prize draw is a form of incentive where all participants are entered into a draw. In practice, this might allow the researchers to offer a more attractive incentive than would be possible if every participant were given the incentive. Different institutions will have their own policy settings on draws and there may be legal requirements in that jurisdiction (with regard to the terms and conditions of the draw).

It is important for SoTL researchers to know the relevant policy setting of the sites where the research will be conducted. For multi-site research, this may require different approaches at different sites.

3.12 Recruitment materialsSection 5.2.23 of the National Statement specifies that prior approval (e.g. by the relevant ethics review body) is required for all recruitment materials prior to the use of those materials. Recruitment materials can include broadcast emails, flyers, posters, letters or advertising used to call for volunteers.

Generally, the materials will be provided at the same time as the application for the ethics review of the work (see 5.0), but in some cases it will be submitted as a variation of the original ethics clearance.

The ethics review of such materials will reflect upon:

the appropriateness of the language used (including not using coercive or pleading language)

whether there is sufficient disclosure of the risks of participating, including with regard to recruitment risks (such as the time commitment required see 3.7)

whether there is sufficient disclosure of the amount of time commitment being sought

whether any third parties will be aware of the participatory status of individuals

whether there will be any screening that might exclude a person who might otherwise be interested in participating (see 3.8).

Some institutions have a central governance process for the authorisation of emails broadcast to large cohorts of students (e.g. a weekly digest email to all students about current research projects seeking more than a specified number of students). Such a process will generally reflect the volume of research that students are being contacted about, the institution’s duty of care to the students, what else is going on at the moment (e.g. the collection of official data for reporting purposes) and whether the research is consistent with the values and goals of the institution.

Inset Ten – A SoTL project will explore how students balance their studies with any concurrent employment and will investigate how family/carer responsibilities affect study. The researchers have decided to include the potentially different experiences and challenges facing international students studying in Australia and offshore.

The researchers are very conscious of the possibility the students might feel pressured to participate and interviewing the students individually might cause them anxiety. They identify several key international student markets and ensure that their research complies with relevant research ethics guidelines in those countries. They decide to restrict offshore participation to students from those jurisdictions.

The researchers liaise with the International Students Office (ISO) to recruit the students, to reinforce to the students that participation is voluntary and will not impact upon the services they receive, their data will be recorded anonymously, and that no one outside the ISO will know whether they participated.

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3.13 Other academic staff and other potential participants who are not studentsMuch of the guidance provided throughout 3.0 has related to students; however, similar issues can apply to research with academic colleagues, industry partners and other participants relevant to SoTL. It important that:

researchers reflect upon the ethical considerations for these participants (e.g. in terms of recruitment, identification, confidentiality, risks and consent)

the application for ethics review (see 5.0) discusses this group, the applicants’ reflections on the above matters and the intended approach

a consent mechanism or consent materials be produced for these participants.

Back to contents

4.0 Approaches to consentThe concept of voluntary consent as a requirement for human research has considerable history, tracing back at least to the Nuremberg Code. Responses to apparent scandals in health and psychology research, such as the Tuskegee Trial and Milgram’s Obedience to Authority, and Zimbardo’s mock prison at Stanford University, heightened community, media, political and regulatory concern about consent in human research. As a consequence, the consent requirement is a central feature of the National Statement and comparable documents elsewhere in the world.

The National Statement defines consent as being a large component of the core ethical principle of respect for persons and includes two chapters on consent: Chapter 2.2 General requirements for consent; and Chapter 2.3: Qualifying or waiving conditions for consent. The National Statement also contains additional references with regard to specific methodologies, potential participant pools and contexts.

To be considered valid for human research, a consent strategy must:

provide potential participants with sufficient information about the project they are being asked to participate in

explain how individuals can express consent

record that participants have consented (unless doing so is a source of risk to participants).

Fundamental to this exercise is respecting an individual’s right to self-determination.

Driven in part by the framing of international human research ethics standards, the accepted model for obtaining consent was the provision of an information sheet to potential participants who then complete and sign a consent form if they are willing to participate. Such an approach is not practical for some research designs (such as telephone-based research), can appear heavy-handed for some research (such as a discussion between two peers about an innocuous topic) and can actually be a source of risk or ethical tension (creating a signed document that

Inset Eleven– Researchers as part of an OLT-funded action research project will be working with colleagues to integrate a new self-assessment and peer assessment approach within the school.

The research activities and data collected/analysed are very likely to organically change over the two semester study period. At the beginning of the work it is impossaible to predict the privacy/risk issues and other ethical sensitivities, nor will it be possible to predict what the research outputs will be from this work.

Consequently the initial consent materials broadly describe the objectives of the project and a general commitment to work together in a respectful, open and honest fashion with regard to the evolving collaboration.

During the work the collaborating academics wil meet each month to discuss how the work is evolving, to reach agreement in terms of any emergent issues (such as the degree to which individuals will be identifiable when a particular issue is reported and to reconfirm consent,

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might expose a participant to risk). In addition, the idea that individuals can be ‘consented’ in a one-off operation runs counter to some methodologies. Indeed, many researchers have argued that consent should not be limited to the beginning of the research project but, rather, should be dynamic and continuous (see Inset Eleven for an example of this). This point has been made particularly forcefully by anthropologists and allows a far more nuanced and responsive approach than the default position of ‘show, tell and sign’.

Unlike earlier Australian documents, the 2007 edition of the National Statement recognises in paragraphs 2.2.5 and 2.2.7 that there can be several ways of obtaining and establishing consent. This section discusses a number of consent strategies that can be useful, valid and relevant for SoTL research.

4.1 Written Information sheet and completed consent formFor many research designs, the combination of a written information sheet and consent form remain the most common consent strategy. Some ethics reviewers may even consider it the standard and preferred approach. Some advantages of this approach are that individuals have a written description about the research for their later review and consideration; the researchers have a written record of the express consent of all the participants; and in some cases the use of a formalised consent process can help researchers with multiple roles clearly identify which of their interactions with participants occurs within the research context (as opposed to through friendship or other work-related capacity).

Other methods of establishing consent are often used, especially in qualitative research. The most common criticisms of written processes by qualitative researchers (especially in the social sciences, humanities and fine arts) are:

the contractual and legalistic exchange can distort or even undermine the relationship between the researcher and participants

it does not reflect the realities of research designs where consent should be a more ongoing and iterative process (e.g. as in longitudinal research or long case studies)

such a process presents a project as being fully determined where it may actually change over time more organically (e.g. as in case studies)

it can imply or even impose a power relationship which could be unhelpful for the research

such an approach tends to imply the signing of the form is more important than the conversation between participant and the researcher

the language and length of written consent materials can be daunting for participants and not actually facilitate genuinely consent

potential participants might conclude that the researcher (and/or the researcher’s employer) is far more concerned with minimising liability, rather than obtaining consent.

It is also worth noting that such an approach to consent can be completely inappropriate in some cultural contexts (Israel, 2015).

If a written consent process is proposed, none of the above is insurmountable but it should be carefully considered when designing such a written consent package for SoTL research.

4.1.1 EXCHANGE OF MATERIALS PRIOR TO DATA COLLECTIONFor some research designs (e.g. telephone-based interviews, email and internet-based research, and even some face-to-face data collection), a variant of this process involves the researcher sending the potential participant the information sheet and consent form (e.g. by email) and the individual sending back the completed consent form. If there are risks associated with third parties knowing the participatory status of individuals, researchers must consider the security vulnerability of such a strategy.

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4.1.2 SURVEYSIn most cases, the survey cover sheet will be the information sheet for the project and participants express their consent by completing and returning the survey. This should be explained in the cover sheet and potential participants should be prompted to retain the sheet for their later reference. The use of this mechanism can be especially important when it is considered desirable to conceal the participatory status of individuals from the researcher and this can be readily achieved with online surveys.

4.2 Written information sheet and verbal consentAnother valid approach to consent involves providing participants with an information sheet to which individuals respond by providing verbal consent. Such a strategy can be appropriate when the researcher does not have authority over the potential participants, where participants are likely to be able to safeguard their own rights and/or such a mechanism is the most respectful approach. A written information sheet and verbal consent may also be appropriate where participants are likely to be worried about there being any record of their involvement in the research. In the absence of such concerns, the researcher should make a dated file note that the individual was provided with the information sheet and consented to participate on that basis.

4.2.1 A SHEET OFFERED TO PARTICIPANTS AFTER THEIR INVOLVEMENT A variant of this process is to provide the information verbally (see 4.3) first, but offer a sheet to the participant at the end of the interview, survey or data collection for their later reference. Such a strategy can be useful for short surveys delivered face-to-face (e.g. surveying students as they enter a recreation area) or after interviewing very senior members of academic staff.

4.3 Verbal consent processIn light of the criticism discussed at 4.1 , at first glance it might seem that a verbal approach to consent is preferable for SoTL research. However, providing all information (see 4.9) verbally can take more time than providing potential participants with an information sheet. Furthermore, a written sheet is something participants can refer back to later (e.g. to remind themselves whether their identified information will be shared with third parties).

An exclusively verbal consent process may not be appropriate for research that involves more than a low risk of harm.

Ethics reviewers might entertain verbal consent as a risk management strategy but are unlikely to accept arguments primarily based upon matters of convenience or maximising participation rates.

In many cases, rather than just using a verbal consent strategy, SoTL researchers should consider the approach discussed at 4.2.

4.4 Limited disclosureProviding less than complete disclosure to potential participants in human research appears to be at odds with the core ethical principle of respect for persons – especially the longstanding expectation that individuals provide their voluntary and informed consent prior to participating in research.

However, there can be valid research reasons for providing only limited disclosure to potential participants. Below are four examples relevant to SoTL research. These should not be regarded as the only situations where limited disclosure could be justifiable.

Chapter 2.3 of the National Statement discusses the ethical issues associated with ‘limited disclosure’ and outlines the limited circumstances where such research can be considered ethically acceptable and the ethical criteria that need to be satisfied.

Essentially the ethical justification of such a situation rests upon questions such as:

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Is this the only way to conduct the research?

Do the anticipated benefits of the research justify such an approach?

Does this expose participants to increased risk?

What will be done after the data collection has occurred? (i.e. will there be a disclosure to the participants of the limited disclosure and will they be given the opportunity to withdraw their data?)

Is it reasonable to assume that a person would agree to participate if they were aware of the full facts about the project?

When applying for ethics clearance for limited disclosure, it is not sufficient simply to indicate that it would otherwise be difficult to collect the data or to refer to the burden on the research team associated with seeking voluntary consent. A case needs to be made to show that all of the review criteria listed in paragraph 2.3.1 or 2.3.2 will be satisfied.

When planning a research project involving limited disclosure, SoTL researchers must confirm the relevant policy settings of the sites where the research will be conducted (see the comments with regard to the four examples below).

4.4.1 EXAMPLE 1: OBSERVATION OF NONSENSITIVE BEHAVIOUR IN A PUBLIC SPACEA SoTL research project will explore the unacceptable number of first year mathematical science students who withdraw before the end of semester one. A small team of researchers will observe stalls at the ‘O Week’ of five universities that profile new early intervention and support services. The researchers will make notes about how members of the university community interact with the material and volunteers staffing the stalls.

They will not conduct any interviews and will not record any personally identifying information, but will record comments about what they have observed. The researchers will not be hiding what they are doing but don’t intend to ask permission before making notes about their observations. Consequently, this is human research and it does constitute limited disclosure.

The researchers can reasonably make a case that:

there will not be any covert observation

what will be observed is not sensitive behaviour and this will occur in a public space

if they initially disclose what they are doing it might impact upon the behaviour of the students

there is potential value in evaluating the early interest of new students.

An important element of whether such an arrangement would be considered justifiable is that no identifiable information about individuals would be collected. Another essential consideration is the degree to which the situation, place and behaviour are such that people are likely to have an expectation of privacy.

It would be prudent, ethically sound (i.e. in terms of respect for persons), and more likely to be acceptable to ethics reviewers (see 5.0) if the researchers:

carry with them information sheets that explain the research, and stress they are not recording information about individuals

make it possible for students to see the notes the researcher has made while observing them so they can see that they will not be identifiable in the research output

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consider discussing the research in advance with the student association as a representative of the student population.

If the researchers intend to collect more information about individual interactions after an observed interaction, the researcher should approach the student to explain:

about the research, including why they were observed

the reasons why it was necessary to observe the student prior to their consent

what information about them has been collected and how it will be used

that they can direct that the collected information not be used for research and be erased.

Where such an approach and arrangements are in place, many institutions will review the research via an expedited ethics review pathway. See 5.0 for more about ethics review.

4.4.2 EXAMPLE 2: OBSERVATION THAT IS COVERT, OR IS OF SENSITIVE BEHAVIOUR OR IS NOT IN A PUBLIC SPACEAs a further component of the research described at 4.4.2, researchers want to covertly observe participants in a supplementary skills workshop for those students who are having difficulties in the mathematical science degree. They will set up a disguised camera and microphone and want to record interactions between the students and tutor, as well as among the students.

Such a situation would be considered covert observation.

In this scenario, it is worth noting that:

there is likely to be a much greater chance of embarrassment and social risk than in the research described in 4.2.1

unlike a person browsing at an information stall (as was the case at 4.4.2), students at a supplementary study workshop are more likely to be vulnerable to harm and more likely to perceive pressure to assist the researcher

there are potential legal sensitivities in recording students without their prior consent

it may be difficult to ‘exclude from the frame’ of the recordings any individuals who later direct they don’t want the recordings of them to be used for research purposes.

As per NS2.3, as long as there is the kind of disclosure and consent process described at 4.4.2 , the study may still be eligible for review outside of an HREC – though some institutions may require a panel review. If there

Inset Twelve – Those who collect anonymised data as part of non-participant observation in public spaces have argued for a long time that informed consent is simply not required. This argument has been extended to public areas online on the basis either that the data involved is publicly accessible or that it is perceived as public by participants. Despite these attempted distinctions, in practice it is not always clear whether or not particular internet sites should be treated as private, public or, indeed, semi-public: ‘what constitutes “person-based” research in cyberspace is much disputed – one person’s “text-based” study is another’s person-based study’ (McKee, 2008, p. 106). Natasha Whiteman (2012) invited researchers to assess the environment, content and tacit and explicit markers of privacy when reaching a decision. She also argued that, as in the offline environment, decisions about the public nature of a site should be revisited throughout the research, as the status of sites may change.

The ‘Tastes, Ties and Time’ project harvested four years’ worth of demographic, relational and cultural data from the Facebook profiles of the 2006 Harvard first-year cohort and connected the data to the university’s housing records. The researchers did not seek informed consent on the basis that their work was akin to observation in a public space: ‘We have not interviewed anyone, nor asked them for any information, nor made information about them public’ (Kaufman, 2008). Zimmer (2010) was highly critical of the project, pointing out that the data was often only available to the researchers because they were in the same Facebook college network as the students and were therefore not subject to the blocks many students had placed on access to their pages from the outside world.

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won’t be a disclosure and reconfirmed consent, the work would require full ethics review by the relevant HREC and the review of the project would need to be publicly disclosed. See 5.0 for more about ethics review.

It is not always straightforward to identify whether a particular location is understood to be public space. This issue extends to cyberspace (see Inset Twelve).

4.4.3 EXAMPLE 3: LIMITED DISCLOSURE WITH NO DECEPTIONA SoTL researcher is interested in how small groups of undergraduate students work on collaborative projects involving unfamiliar tasks.

The researcher is course convenor for a unit where education students will be exploring how drama can be usefully incorporated into high school foreign language programs. The major assessment items will be participation in online class discussions about the course readings, an assignment about different approaches to the use of drama in education, and then in groups of three designing a drama-based semester unit plan for grade 10 students studying Chinese. For discussion of the course readings, the students will be using a web-based tool (with facilities for feedback and discussion). For the group task, the students will be using a virtual learning environment to brainstorm ideas, design the unit plan and compile teaching notes for a teacher who might not have any background in the use of drama in teaching. The researcher will collect data from the students.

The students are aware the course convenor is monitoring and evaluating the online class discussion, and that she will periodically enter the virtual study spaces and assess the final unit plans produced by the groups. They are not aware the course convenor has a research interest in the dynamics of students’ work on an unfamiliar task and are not aware her research interest specifically relates to students who don’t have any drama training.

This situation constitutes limited disclosure, but the researcher can reasonably make a case that there has not been any deception of students. She probably can also contend that:

if she had initially disclosed her research interest to the students it might have had an impact on the behaviour of the students

there is potential value in expanding pedagogical knowledge in this area and there are only very minor risks that are minimised using the strategies discussed below

the limited disclosure will be disclosed to the students after the grades for the semester have been issued; this will include an explanation of why the limited disclosure was necessary and a mechanism where students can direct they do not consent for their data to be used for research purposes.

Students will not be asked for their consent until after their grades have been issued – mitigating the risk they might worry their decision about participating could affect their grades. When conducting the analysis and reporting the research she will take care to de-identify individuals, being conscious of the potential for ‘internal identification’ (see 3.6) and reconfirming the consent of any individuals where their comments will be used (see Inset 6).

Where such arrangements are in place, many institutions will review the research via an expedited ethics review pathway. See 5.0 for more about ethics review.

4.4.3 EXAMPLE 4: ACTIVE DECEPTIONFor a national teaching fellowship, a researcher will be investigating the degree to which personality type is a useful determiner of success in management and human resource management degrees. As part of this work, the researcher will be surveying current students, students who graduated five years ago and students who withdrew five years ago.

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The recruitment and consent material will indicate that the survey relates to goals, aspirations and general attitudes. Instead, the survey will evaluate the respondents with regard to Autism Spectrum Disorder, affect, compassion and altruism.

Setting aside any questions about scientific validity, this work clearly involves the intentional deception of participants, who are likely to be concerned and upset when they learn of the real objectives of the research. If there will later be a disclosure to participants and an explanation of the de-identification of the participants (see 3.0 for some related considerations), the work may qualify for review outside of an HREC. If a disclosure is not to be made, and participants are not afforded the opportunity to withdraw their data, the project would have to be reviewed by an HREC and the review of the project would need to be publicly disclosed. See 5.0 for more about ethics review. For an example of how psychologists deceived their own psychology students, see Zhang and Moore (2005) and Booklet 6 of this manual.

4.5 Embedded consentEmbedded consent refers to situations where consent for the researchers’ use of comments, results, work samples or other data will be embedded within another wider consent.

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See Inset Thirteen for an example of embedded consent and some reflection on the issues.

It is very important that it be clearly explained that potential participants can decide separately whether to consent to the wider activity and whether to consent to the research. This can be especially significant if the wider activity might be seen as desirable by potential participants because individuals may worry that their decision about participating in the research might affect their access to the wider activity.

There may be situations where participants in the wider activity must agree to be involved in the research (e.g. because funding for the research is paying for the wider activities). In such instances, ethics reviewers will need to be satisfied the potential benefits of the research (preferably to the participants) justify the burdens placed upon them.

4.6 Students who are under 18 years of ageMany institutions interpreted the first edition of the National Statement to mean that persons aged under 18 years of age could only participate with the consent of their parent/guardian. For SoTL research, this could result in an undesirable situation where in the same class students who are aged 18 years and five months could consent in their own right and persons aged 17 years and ten months would need the consent of a parent/guardian – irrespective of the risks and ethical issues concerned, the capacity of the young person, whether they were living independently or whether there was continuing contact between students and parents.

Fortunately, Chapter 4.2 of the current edition of the National Statement encourages researchers (and ethics reviewers) to consider the capacity of young people to consent for themselves. Such assessments require a project-specific reflection of:

the complexity of the research

the nature of the risks and burdens

the general characteristics of the cohort.

Researchers must also reflect upon the specific understanding and capacity to consent of potential participants. Section 4.2.4 of the National Statement specifies that it is only ethically appropriate to include children (who lack the capacity to provide consent in their own right) in research when the research is likely to make an important contribution to the body of knowledge in an area important to the health, welfare or other area important to children; and their involvement is indispensable.

In practice, for most SoTL research in Australia it would be appropriate for first year university students aged under 18 years of age to give their own consent, and paragraph 4.2.8 of the National Statement can be relied on to authorise this. For younger persons (e.g. students still at high school) there must be the kind of reflection described above, which must be shared with the ethics reviewers. Where researchers are engaged in comparative research, they need to be careful to explore whether other jurisdictions may take a different view.

It should be noted that the ethical principle of justice precludes the exclusion of potential participants on the basis of age unless such exclusion is based upon valid research reasons (e.g. the topic of the research relates to mature-aged students attending university for the first time, so the potential participant pool can

Inset Thirteen – The wider activity is a series of workshops on academic writing for international students including appropriate referencing.

The university is collecting data to evaluate the program. Grades and work samples before, during and after the workshops will be evaluated. Embedded into the consent for the program, consent will also be sought for the research use of the grades and samples.

Obviously, participation in the program is likely to be considered desirable by the students. Consequently, it is vital that participants in the program are not obliged to consent to the use of their grades for research. It is probably important to reinforce that their decision will not affect the assistance they will receive.

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appropriately be screened to exclude students aged under 25 years). Any exclusions based on age should be disclosed when reporting the results of the research.

4.7 Waiver of the consent requirementThe privacy component of the ethical principle of granting due respect to people provides that identified personal information (especially sensitive information) should generally only be accessed with the prior consent of the individual. This is the case even when a researcher has authorisation to access the information for another purpose (e.g. an academic staff member might be authorised to access the postal address of students in her course, but that does not mean she could use those addresses to write to students living in a geographic location to seek their consent to participate in her research).

Chapter 2.3 of the National Statement discusses circumstances where an HREC can waive the consent requirement. This mechanism might be useful or appropriate for situations where it is impractical to seek the consent of the participants.

However, one criterion in Chapter 2.3 is that such a waiver is only available if not prohibited by State or federal law. Privacy legislation generally does not allow an institution to release identified personal information to researchers without the prior consent of the persons identified in that information. However, if specified procedures are followed, that legislation will allow release of identified health information for research and of some personal information for medical research. The former might be relevant to SoTL researchers when matching health and education data, for example.

Booklet 5 of the SoTL resource manual discusses the arrangements under which an HREC can approve a waiver of the informed consent requirement. The booklet discusses the limitations on what waivers can be granted (e.g. with regard to the use of information for medical research as defined by the Commonwealth Privacy Act ) and the matters that will be considered (e.g. a public interest test) before an HREC approves a waiver.

In practice, this means that:

a waiver is not required for access to or use of de-identified personal information or where the relevant individuals have consented to the access or use

a waiver cannot be granted where it is precluded by law (which, as noted above, is the case for all personal information that is not health information – sensitive and not sensitive)

in limited circumstances an HREC can grant a waiver of the consent requirement that will allow the use of Commonwealth-held personal information for medical research or of State or privately held health information for research

as a result, for most SoTL research, identified personal information can only be accessed and used with the prior consent of the individuals concerned.

See 2.3 of Booklet 5 of this manual for more about the waiver of the consent requirement.

4.8 Opt-out approachIn 2014, Chapter 2.3 of the National Statement was updated to include a new provision relating to the opt-out approach to recruitment and consent.

These arrangements allow for situations where, rather than participants expressing consent or an HREC waiving the consent requirement, potential participants are informed about the project and if they don’t respond within a specified timeframe they are deemed to have consented.

To be considered ethically acceptable the opt-out approach should only be used where:

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the research involves no more than a low risk of harm

there is a genuine public interest in maximising the number of persons or amount of data collected, which would be undermined if express consent was sought

reasonable attempts are made to provide all prospective participants with appropriate plain language information explaining the nature of the information to be collected, the purpose of collecting it, and the procedure to decline participation or withdraw from the research

a reasonable time period is allowed between the provision of information to prospective participants and the use of their data so that an opportunity for them to decline to participate is provided before the research begins

the mechanism will include all of the required features (see 4.9)

the data collected will be managed and maintained in accordance with relevant security standards

there is a governance process in place that delineates specific responsibility for the project and for the appropriate management of the data

and

the opt-out approach is not prohibited by State, federal or international law.

The NHMRC has corresponded with the Office of the Federal Information Commissioner with regard to the way the opt-out approach works in relation to the Privacy Act. In light of this correspondence, the opt-out approach should not be used with regard to sensitive identified personal information such as health information. Instead, either express consent (see 4.1, 4.2 or 4.3) or a waiver of the informed consent requirement (see 4.7) must be obtained.

See Inset Fourteen for an example of the opt-out approach for SoTL research.

4.9 Required featuresThe National Statement specifies some information that should be present in all consent materials/mechanisms for them to be considered acceptable. These features are included in the list below.

Most Australian institutions will have their own additional requirements and may provide a template or have standard consent materials. The list below includes typical institutional requirements. However, it is

Inset Fourteen – A researcher has been a convenor of a relatively new social justice theme within an undergraduate social science degree. During the last five semesters, various guests from a range of external bodies (e.g. civil libertarian organisations) have been invited to deliver talks and participate in group discussions with the students. The students have been encouraged to share their reflections and feedback with each other on a dedicated online discussion board.

Given that the course is new and the discussion is particularly rich, the researcher hopes to use comments for a SoTL project.

Personal identifiers will be removed from student comments. Consequently, the risks to the students are minimal.

Many of the students are still at the university, the researcher has private email addresses for many former students and a great proportion of former students are involved in a social media page for the school.

The researcher will email an opt-out information sheet to the students for which he still has contact details (and ask them to send it on to any classmates they remain in contact with. The researcher will also post the details of the research and link to the opt-out information sheet on the school’s Facebook page.

The researcher will allow 60 days for the potential participants to opt-out. When seeking ethical clearance the researcher argues that: it is important to have as close as possible to all the comments for analysis; it is possible to remove personal identifiers (especially given the large volume of comments and students involved; and it is important to include comments that, in hindsight, the students might regret.

While seeking a waiver of the consent requirement might be aviable alternative (see 4.7), the researcher does want to give students details of his intended use of their comments and offer them an opportunity to opt-out.

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important to remember that the primary objective of a consent mechanism is facilitating the voluntary and informed consent of potential participants. The language used in the materials should be appropriate (e.g. should not use jargon and technical terms unless these would be familiar to all potential participants) and should be respectful.

In the case of multi-institution studies, researchers should consult the various institutional guidelines to check requirements across the various sites and discuss with the relevant research offices if any of the requirements conflict with the other institutions.

4.9.1 INSTITUTIONAL BRANDINGThe material should indicate the institution(s) under which the research is being undertaken.

4.9.2 TITLE OF THE RESEARCH PROJECT/WORKThe material should state the title of the research.

4.9.3 RESEARCH TEAMThe names, institution and a contact method for the research team must be listed. Ideally, this would include all the individuals who will collect the data, conduct the research and/or have access to the data (especially personally identified information), including students and research assistants. This, however, may not be practical for large or ‘fluid’ teams. In which case good practice would be to have a web page where all of the current researchers are listed.

4.9.4 WHY IS THE RESEARCH BEING CONDUCTED?A short statement about the reasons why the research is being conducted should be included. This may be a useful place to discuss any potential conflicts of interest.

4.9.5 WHAT PARTICIPATION INVOLVESPotential participants should be provided with a description of what their participation entails. This might be the place to discuss time commitment and burden.

4.9.6 HOW POTENTIAL PARTICIPANTS WERE SELECTEDPotential participants should be provided with some information about why they have been approached about participating and (if relevant) how it is that their contact details have been obtained. This may be a source of concern for potential participants and could be a regulatory privacy concern. See Inset Fifteen for an example approach to the use of materials.

4.9.7 SCREENING OF POTENTIAL PARTICIPANTSIf the potential participant pool will be screened in any way this should be explained so individuals understand that even if they are interested in participating they may be excluded.

4.9.8 EXPECTED BENEFITS OF THE RESEARCHThe consent materials must provide an accurate and balanced (i.e. not inflated or exaggerated) description of the expected benefits of the research. This should include a description of to whom those benefits are likely to flow.

Inset Fifteen – Example of text that will be sent to those currently studying at Fabulous University who have registered with the Disability Support Unit within Academic Administration because of a visual impairment:

This information sheet has been distributed by the Disability Support Unit to all Fabulous University students registered with it as living with a visual impairment. The researchers have not be provided with your name or contact details. We will only know who you are if you elect to contact us to discuss this project further.

The researchers will not be letting the Disability Support Unit know who elects to participate or share with them any identifying information unless you ask us to do so.

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4.9.9 RISKS OF THE RESEARCHPotential participants must be provided with information about the risks and burdens of the research, the strategies to minimise or negate them, strategies to manage any harms and any other strategies to mitigate the risks/harms. This includes matters that the researchers feel have been addressed by the design and risks that the researchers feel are present in the ‘normal activity’ of the potential participants.

4.9.10 CONFIDENTIALITY Discussions about confidentiality and privacy are an important component of obtaining consent from potential participants. The matters that may need to be discussed include:

Who will know whether individuals decide to participate (e.g. the researcher, other participants, the peers or colleagues of the participants, other third parties)?

Will the data be collected with personal identifiers, in a coded form or without any personal identifiers?

If the data was collected in a personally identified form, will the identifiers be removed at some stage?

If the data was collected in a coded form, will the code key be erased at some stage?

Will the researcher be able to correspond, link or identify data with individual participants?

What are the storage arrangements for the data? Will it be stored with personal identifiers, in a coded form or without any personal identifiers? Who will have access to the data? How will access to the data be controlled?

How will the results of the research be reported or published? Will participants be identifiable (including by inference by persons who know the participants)?

Are there circumstances where personally identified data may need to be shared with third parties (e.g. because the researchers believe a participant may harm themselves or others)?

How long will the data, samples or comments be retained (e.g. for the timeframes stipulated by the Australian Code for the Responsible Conduct of Research)? Do the researchers wish to retain the materials for a longer period? Why? Will the materials be reused or shared with other researchers and, if so, in what form?

4.9.11 REGULATORY PRIVACY STATEMENTIf data is collected in a personally identified form, or if the researchers have access to information that could be practically used to identify participants, the consent materials may need to include a regulatory privacy statement (e.g. as per Australian Privacy Principle 5).

4.9.12 FURTHER QUESTIONSPotential participants should be invited to contact the researchers with any further questions in relation to the research.

4.9.12 VOLUNTARY PARTICIPATIONThe materials must make it clear that participation in the research (see 4.5) is voluntary.

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4.9.13 CONTACT FOR CONCERNS AND COMPLAINTSPotential participants in research must be provided with contact details for raising concerns or complaints about the ethical conduct of the research. Institutions are required to establish arrangements, independent of research teams, to receive and review such matters. In many cases, the listed contact person will be the ethics officer or manager. When working with cohorts whose comprehension of English may be poor (some exchange students, students studying offshore), it may be necessary to offer a contact person proficient in the cohort’s preferred language.

4.9.14 FEEDBACK TO PARTICIPANTS As a general principle, participants should always be offered a summary of the overall results of the research (NS 1.5). This should be provided in a timely manner and using language appropriate for the participant pool. In practice, a copy of a journal article may be neither timely nor appropriate. Generally researchers should make available to participants a lay summary of the outcomes of the research as soon as possible after their participation. If participation in the research has been anonymous, the feedback mechanism must not undermine that anonymity.

4.9.15 DEBRIEFING OF PARTICIPANTSRelated to the provision of feedback to participants on the overall results of the research (see 4.9.14), it may be appropriate to also offer debriefing on an individual participant’s own results. This may be particularly important if the individual results may be of concern to a participant. In cases where participants will be provided with their own results, this may be one of the reasons why individuals have decided to participate and may be the primary benefit to participants. The feedback mechanism must safeguard the privacy of participants, as this may otherwise be a source of risk.

4.9.16 OPTIONAL FEATURESDepending upon the exact design of a project, potential participants, consent mechanism and context, the consent materials may need to include additional features (e.g. details of the prize draw to encourage participation).

4.10 Ethics reviewThe planned approach to consent will be an important consideration during the ethics review of a project. The reviewers will need details of the approach that will be taken to ensure the consent obtained from participants:

treats them with respect

facilitates an informed decision

is voluntary

establishes their wishes.

See 5.0 for more about ethics review.

4.11 Consent materialsSection 5.2.23 of the National Statement specifies that the consent material must be approved by the ethics review body prior to their use. See 5.0 for more about ethics review.

4.12 Consent record keepingRecords of participant consent should be retained for at least as long as the data (see 4.9.10-ix) and may be required by the institution’s disposal schedule to be retained for longer. Researchers should confirm this with the relevant institution’s research office.

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4.13 Data collection while seeking consentThe consent mechanism should not be used to collect research data (e.g. the inclusion of demographic questions for research analysis). If consent will be recorded in an audiovisual form (verbal consent that is digitally recorded) this should be clearly and separately recorded (e.g. the researcher clearly distinguishing between confirming consent and collecting the data, and preferably recorded as separate digital recordings).

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5.0 Ethics reviewAs discussed in Booklet 2 of this resource manual, the ethics review of a project primarily relates to considering the degree to which a planned project addresses four core principles. One of these principles is respect for people, which encapsulates the design and conduct of a project’s recruitment and consent strategies.

Throughout this booklet there is a discussion of important considerations for SoTL researchers.

The following are some hints and tips for SoTL researchers to assist with common ethical challenges and to help researchers avoid frequent (but very avoidable) ethics review delays and problems.

Have a clear idea of the category of persons required for the work (so as to explore the research question/meet the ojectives of the project).

Review the relevant resource and guidance material of the relevant institutions.

Identify any matters where you will need to share your reflections and/or justify your approach.

Consult with the relevant research office, HREC chair or research ethics adviser.

Consider how you will contact the cohort of potential participants.

Consider, if you intend to use a university list of potential participants, whether there are any regulatory privacy considerations.

Assess whether the potential participants are in a dependent relationship with you. If so, identify strategies to ensure participation will be voluntary.

Identify whether you need to know the participatory status of individuals.

Consider if peer pressure or peer reaction are potential issues for the research.

Will you screen potential participants? How will they be screened? What will screened potential participants be told?

Judge if there are risks associated with being a potential participant, being screened and excluded or being assessed as eligible to participate.

Attach to the application for ethics review a copy of any advertisement, social media post, email or other recruitment text.

Explain what approach will be used to seek the voluntary and informed consent of the potential participants.

Check that the draft consent materials/approach include all of the required information and assurances.

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Attach to the application for ethics review a copy of any consent materials.

Refer to Booklet 2 for more about ethics review.

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6.0 Sources of adviceRecipients of ALTC and OLT grant and fellowship funding have highlighted the importance of seeking advice on research ethics and ethics review. Ethics reviewers and research ethics managers have made the same observation.

An important early step is participating in the research ethics training at your institution.

There are a number of sources of useful advice available to SoTL researchers, these include:

the other booklets of this resource manual

any resources, guidelines and policies produced by your institution

the limited SoTL literature that considers research ethics

a research ethics adviser (REA) (if your institution has any) or the chair of the HREC/research ethics manager if no REA is available

a SoTL adviser (if your institution has any who are experienced with SoTL research)

other SoTL researchers at your institution or in your professional networks.

Advice should be sought as early as possible in the design of your work and definitely prior to submitting an application for ethics review. These same sources of advice can be helpful when responding to review feedback,

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7.0 ReferencesBurman, ME & Kleinsasser, AM 2004, ‘Ethical guidelines for use of student work: Moving from teaching’s invisibility to inquiry’s visibility in the scholarship of teaching and learning’, The Journal of General Education, vol. 53, no. 1, pp. 59–79.

Diamond, MR & Reidpath, DD 1992, ‘Psychology ethics down under: A survey of student subject pools in Australia’, Ethics & Behavior, vol. 2, no. 2, pp. 101–108.

Israel, M 2015, Research Ethics and Integrity for Social Scientists: Beyond Regulatory Compliance,Sage, London.

Israel, M, Allen, G & Thomson, C (in press) 2016, ‘Australian research ethics governance: Plotting the demise of the adversarial culture’, in van den Hoonaard, W & Hamilton, A (eds) The Ethics Rupture: Exploring Alternatives to Formal Research-Ethics Review, University of Toronto Press, Toronto.

Kaufman, J 2008, Blog comment from October 2, ‘Michael – We did not Consult’, in Zimmer, M (blog author) On the ‘Anonymity’ or the Facebook Dataset (Updated). Available at: http://michaelzimmer.org/2008/09/30/on-the-anonymity-of-the-facebook-dataset/ (viewed 13 January 2014).

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MacLean, M & Poole, G 2010, ‘An introduction to ethical considerations for novices to research in teaching and learning in Canada’, The Canadian Journal for the Scholarship of Teaching and Learning, vol. 1, no. 2, Article 7. Available at: http://ir.lib.uwo.ca/cjsotl_rcacea/vol1/iss2/7

McKee, HA 2008, ‘Ethical and legal issues for writing researchers in an age of media convergence’, Computers and Composition vol. 25, pp.104–122.

NHMRC 2007, National Statement on Ethical Conduct in Human Research. Available at: http://www.nhmrc.gov.au/guidelines-publications/e72 (Viewed 7 March 2015).

Tolich, M 2004, ‘Internal confidentiality: When confidentiality assurances fail relational informants’, Qualitative Sociology, vol. 27, no. 1, pp. 101–106.

Whiteman, N 2012, Undoing Ethics: Rethinking Practice in Online Research, Springer, London.

Zhang, Y & Moore, KE 2005, ‘A class demonstration using deception to promote student involvement with research ethics’, College Teaching vol. 53, pp. 155–157.

Zimmer, M 2010, ‘“But the data is already public”: On the ethics of research in Facebook’, Ethics and Information Technology, vol. 12, no. 4, pp. 313–325.

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8.0 AcknowledgementsThis resource was commissioned by the Australian Government Office for Learning and Teaching, and produced by Dr Gary Allen (Griffith University), Prof. Colin Thomson (University of Wollongong) and Prof. Mark Israel (University of Western Australia). You can find a summary of our biographies here and a summary of our work here.

The authors would like to acknowledge our colleagues – researchers, ethics reviewers and professional staff – who have shared with us the ethical challenges and frustrations they face and useful strategies to avoid, minimise and otherwise mitigate against the problems and delays they can sometimes cause.

The matters discussed in this resource manual are discussed in more detail in the Griffith University Research Ethics Manual. The GUREM is available for purchase by research institutions.

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9.0 Glossary

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Australian Learning and Teaching Council

ALTC

Australian Research Council

ARC

Griffith University Research Ethics Manual

GUREM

Human research ethics committee

HREC

National Health and Medical Research Council

NHMRC

Australian Government Office for Learning and Teaching

OLT

Research Ethics Adviser

REA

Scholarship of Teaching and Learning

SoTL