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The inclusion of retracted trials in systematic reviews: implications for patients’ safety0

 

After a paper has been through peer review and has been published it is the obligation of the scientific community to scrutinise an author’s work. If a serious error or misconduct is spotted the paper should be retracted and the work is removed from the evidence base. Over the past ten years there has been an exponential growth in the number of retracted papers. Much of the increase may be explained by the use of technology that has made it easier to spot duplicate publications, or fabricated data, for example. Once a paper is retracted researchers should not cite this work in future publications; this is, however, not the case. Many papers continue to be cited long after they have been retracted. Retraction Watch has a list of the ten most highly cited retracted papers. The paper that currently holds the number one spot has been cited a total of 942 times, after retraction. It is plausible that researchers are using retracted work to justify further study. This may be the scientific equivalent of “fruit of the poisonous tree”. That is to say, if the research is based on tainted work then that work is itself tainted. Authors may also include retracted work in systematic reviews and meta-analyses. In clinical disciplines – such as nursing or medicine – this is particularly worrisome.

Clinical practice should be based on the best available evidence, i.e. from systematic reviews. If a review were to include a retracted paper then the resulting meta-analysis would be contaminated and recommendations for practice emerging from the study would be unsound; ipso facto putting patients at risk because a clinician is using evidence that is flawed. To date we have found five examples in the nursing literature where this has happened. We have written to the journal editors to advise then of the error that authors have made. In our minds this is a cut and dry issue. The author has clearly made an error, potentially a serious error and one that will need to be resolved. Either the editor will need to issue an erratum or potentially retract the review (and there are examples in the literature where this has happened).

There is a second way in which a systematic review may include research that is retracted. This is when the authors of the review cite a paper that is retracted after the review is published. A more nuanced debate is perhaps required given that the review author has not made a mistake. Would it not be punitive to the author – potentially damaging their career prospects – to retract a review when they have not made a mistake? However, the inclusion of a paper that has subsequently been retracted has the potential to impact effect sizes in meta-analysis and/or review conclusions. My group undertook a study to explore how often retracted clinical trials were included in systematic reviews. The answer; more common than you might think. We followed up the citations of eleven retracted nursing trials and determined that they were included in 23 systematic reviews. Currently there is no mechanism that will alert authors (or publishing editors) that their systematic review includes a study that has subsequently been retracted. We suspect, but don’t know for certain, that in medicine and the allied health professions there are many more systematic reviews that include retracted studies. Clinical practice guidelines, such as those produced by the National Institute of Health and Care Excellence (NICE) rely on evidence from systematic reviews. And this is where our observation flips from being an interesting intellectual exercise to one that may impact patient safety. Could it be that patients are being exposed to ineffective treatments because guidelines are based on flawed reviews?

Journal editors, reviewers and researchers need to be aware and mindful that systematic reviews may contain citations that have been retracted. There is a compelling argument that the editor who issues a retraction notice for a paper also has a duty to alert authors citing this work of the retraction decision. Part of the peer review process should be checking that included references (particularly those included in meta-analysis) are not retracted, it might also be argued. Finally, not only do review authors need to ensure that they have not cited retracted papers, but they also have a responsibility to periodically check (something the Cochrane collaboration encourage authors to do) the status of included studies.

The inclusion of retracted trials is a threat to the integrity of systematic reviews. Consideration needs to be given to how the scientific community responds to the issue with the ultimate goal of keeping patients safe.

Professor Richard Gray is the editor of the Journal of Psychiatric and Mental Health Nursing. No other conflict of interest declared.

Contributor
Richard Gray PhD
Professor of Clinical Nursing Practice, La Trobe University, Melbourne, Australia
Richard’s University profile |  r.gray@latrobe.edu.au

This post may be cited as:
Gray R. (26 May 2018) The inclusion of retracted trials in systematic reviews: implications for patients’ safety. Research Ethics Monthly. Retrieved from: https://ahrecs.com/research-integrity/the-inclusion-of-retracted-trials-in-systematic-reviews-implications-for-patients-safety

Stop centring Western academic ethics: deidentification in social science research – Anna Denejkina0

 

This blog will provide a discussion of issues present in deidentifying marginalised research participants, or research participants who request to be identified, in the publication of qualitative research. As my research is mixed-method (quantitative and multi-method qualitative) it included several data collection techniques and analyses. For this discussion, I will specifically focus on the face-to-face and Skype interviews I conducted with participants in Russia and the United States.

My PhD study investigates intergenerational transmission of combat-related trauma from parent to child, focusing on the Soviet–Afghan war, 1979–89. This research includes interviews with Soviet veterans and family members of veterans; it was these interviews that raised questions of participant erasure and agency. From 12 face-to-face and Skype interview participants, one participant requested complete deidentification; one requested that their real name not be used but their location and other identifying details remain; two participants requested that only their first names be used and their location and other identifying details remain; the eight remaining participants requested that they be fully identified, with some participants sending me photographs of them and their families for inclusion in research publications. Given the social and political sensitivity that persists in Eastern Europe around the discussion of the Soviet invasion into Afghanistan, I had to consider and discuss with participants that requested they be identified the issue of their safety.

My research participants are marginalized participants by virtue of the topic of my research, the Soviet–Afghan war, and the ongoing silencing treatment they’ve received during and following the war by the state:

To take just two examples: in the hope of obscuring the true impact of the war, some local authorities refused to allow special areas in cemeteries to be set apart for the graves of soldiers killed in Afghanistan; while others forbade the cause and place of death to be stated on gravestones or memorial shields. (Aleksievich, Whitby & Whitby 1992, p.5–6)

Given academic broad-stroke standards of deidentifying research participants, we must review the ethics of this practice as it can promote and perpetuate erasure of marginalised participants and the silencing of their voices. Some textbooks on the topic of ethics in the social sciences approach anonymity and deidentification of participants from the angle that anonymity is part of the basic expectations of a research participant, without elaborating that anonymity is not always desirable nor ethical (see for example Ransome 2013), essentially replicating the medical model of human research ethics developed for the regulation of biomedical research in the United States (Dingwall 2016, p.25). Such an approach does not address the issues of presenting anonymity as a status-quo in social research, and makes a sweeping – and a Western academic – generalisation that anonymity is one of the vital assurances researchers must give to their participants to keep within their duty of care (that is, that researchers have at least some obligation to care for their research participants).

This approach to research ethics negates participant agency, particularly those participants that request they be identified in research. Furthermore, forced anonymity can be an act of disrespecting participants (Mattingly 2005, p.455–456) who may have already experienced invisibility and who are then further erased through anonymity by researchers (Scarth & Schafer 2016, p.86); for example, “in some Australian and, in particular, some Indigenous cultures, failing to name sources is both a mark of disrespect and a sign of poor research practice” (Israel, Allen & Thomson 2016, p.296).

As researchers, we must also question if presenting this approach as a vital tenet of social research can become a damaging rule-of-thumb for new researchers who might, therefore, not question the potential undermining of participant agency, and use deidentification unethically as a sweeping regulation within their research without consideration for the individual situations of their research participants. This is part of the issue created by applying a medical model of ethics assessment processes to the social sciences, in which the prevailing interpretation is that deidentification is also required within social research, whereas the reality is that specific agreements between the researcher and the research participant must be honoured.

The ethical dilemma, therefore is: can researchers ethically deidentify participants at the expense of the participants’ agency, potentially perpetuating the historical and symbolic erasure of their voices and experiences? I argue that, based on research design and data collection methods, this decision-making process is an ‘ethics in practice’ and must be approached in context, individually for each study, and for each individual participant.
As scholars, we want to minimise or eradicate harm that might come to our participants through our research. While we think “in advance about how to protect those who are brought into the study” (Tolich 2016, p.30) this must be a continual process throughout our project, in which we “work out the meaning of what constitutes ethical research and human rights in a particular context” (Breckenridge, James & Jops 2016, p.169; also see Ntseane 2009). This is important to note, because protection does not only refer to participants but also to others connected to them. For example, the use of a real name at the request of a participant may expose their family member(s) who were not part of the research.

Consequentialist approaches to ethics suggest that “an action can be considered morally right or obligatory if it will produce the greater possible balance of good over evil” (Israel, 2015: 10; also see Reynolds, 1979). This is an approach we could take to issues around deidentification; however, this also means that researchers must know what is good or bad. In studies like mine, this would mean knowing (or making an attempt, or an assumption to know) what is good or bad for my research participants. This action is infantilising, and places the researcher above the research participant by making the final call ourselves, which is to remove participant agency – if we can assume participants are autonomous during the research consent process, we must also assume that they are autonomous in making decisions with respect to their identification (Said 2016, p.212). Additionally, this action may be culturally insensitive given that Western human research ethics committees follow Western cultural guidelines, centring the dominance of Western academia.

The ethical issues I faced during my PhD research highlight why researchers cannot take a sweeping approach to deidentification in qualitative research – not even for a single study. ‘Ethics in practice’ means that each participant’s situation is analysed individually, and issues around erasure, safety, and their agency weighed against each other to reach a conclusion. I propose that if this conclusion is at odds with the preference of the participant, that it must then be taken back to the participant for further discussion. Not implementing this aspect of ‘ethics in practice’ goes against social science ethics, that we must avoid doing long-term and systemic harm, both of which come through erasure and silencing. We must also remember that “any research project has the potential to further disenfranchise vulnerable groups” (Breckenridge, James & Jops 2016, p.169), and ignoring the wishes of participants regarding their identification due to a Western model of ethics can cause further damage to these groups.

References:
Aleksievich, S., Whitby, J. & Whitby, R. 1992, Zinky Boys: Soviet voices from a forgotten war, Chatto & Windus, London.

Breckenridge, J., James, K. & Jops, P. 2016, ‘Rights, relationship and reciprocity: Ethical research practice with refugee women from Burma and New Delhi, India’, in K. Nakray, M. Alston & K. Whittenbury (eds), Social Sciences Research Ethics for a Globalizing World: Interdisciplinary and Cross-Cultural Perspectives, Routledge, New York, pp. 167–186.

Dingwall, R. 2016, ‘The social costs of ethics regulation’, in W.C. van den Hoonaard & A. Hamilton (eds),The Ethics Rupture, University of Toronto Press, Toronto, pp. 25–42.

Israel, M., Allen, G. & Thomson, C. 2016, ‘Australian research ethics governance: Plotting the demise of the adversarial culture’, in W.C. van der Hoonaard & A. Hamilton (eds),The Ethics Rupture, University of Toronto Press, Toronto, pp. 285–216.

Mattingly, C. 2005, ‘Toward a vulnerable ethics of research practice’, Health: An Inderdisciplinary Journal for the Social Study of Health, Illness and Medicine, vol. 9, no. 4, pp. 453–471.

Ntseane, P.G. 2009, ‘The ethics of the researcher-subject relationship: Experiences from the field’, in D.M. Mertens & P.E. Ginsberg (eds), The Handbook of Social Research Ethics, 1st edn, Sage, Thousand Oaks, pp. 295–307.
Ransome, P. 2013, ‘Social research and professional codes of ethics’, Ethics and Values in Social Research, Palgrave Macmillan, Basingstoke, pp. 24–53.

Said, D.G. 2016, ‘Transforming the lens of vulnerability: Human agency as an ethical consideration in research with refugees’, in K. Nakray, M. Alston & K. Whittenbury (eds),Social Sciences Research Ethics for a Globalizing World: Interdisciplinary and Cross-Cultural Perspectives, Routledge, New York, pp. 208–222.

Scarth, B. & Schafer, C. 2016, ‘Resilient Vulnerabilities: Bereaved Persons Discuss Their Experience of Participating in Thanatology Research’, in M. Tolich (ed.), Qualitative Ethics in Practice, Left Coast Press, Walnut Creek, CA, pp. 85–98.

‘Tolich, M. 2016, ‘Contemporary Ethical Dilemmas in Qualitative Research’, in M. Tolich (ed.), Qualitative Ethics in Practice, Left Coast Press, Walnut Creek, CA, pp. 25–32.

Statement of interest
No interests to declare.

Contributor
Anna Denejkina | Casual Academic and PhD  candidate in the Faculty of Arts and Social Sciences, researching intergenerational trauma transmission UTS | Staff profileAnna.Denejkina@uts.edu.au

This post may be cited as:
Denejkina A. (24 May 2018) Stop centring Western academic ethics: deidentification in social science research. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/stop-centring-western-academic-ethics-deidentification-in-social-science-research-anna-denejkina

On the Problem of “Worldlessness”. Do The Declaration of Helsinki and the Council for International Organizations of Medical Science Guidelines Protect the Stateless in the Research Context?0

 

Associate Professor Deborah Zion
Chair, Victoria University, HREC.
deborah.zion@vu.edu.au

Can these bones live? Ezekiel, 37:3.

The Declaration of Helsinki has considerable guidance on working with vulnerable research participants, and vulnerability in research is the focus of the Council for International Organizations of Medical Science (CIOMS) guidance document. Both of these documents have undergone recent revisions[1]. However, a broader question remains about these and other national guidelines; namely, how can we translate them into practice? When conducting research with one of the world’s most vulnerable populations, namely those seeking asylum, guidelines must be operationalised with creativity so that the research imperative can be fulfilled.

For Hannah Arendt, the refugee was the archetypical figure that revealed the contradiction between universal rights and national sovereignty. For her it was the loss of rights which was, and remains, the defining attribute of the refugee. She insists that the fundamental deprivation of human rights is manifested first and above all in the deprivation of a place in the world.

In Australia the vulnerability experienced by statelessness is further exacerbated by such persons being incarcerated in offshore detention centres on Nauru and in Papua New Guinea, shut away from the oversight of human rights institutions. Nonetheless, there is an imperative to conduct research about this population, in order to record the conditions of detention and to bear witness, as an act of solidarity, the egregious human rights violations suffered by those detained.

What then do the guidelines say about vulnerable populations, and how can we translate this into research with refugees and asylum seekers?

Clause 19 of The Declaration of Helsinki, states that

Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm. All vulnerable groups and individuals should receive specifically considered protection[2].

CIOMS Guideline 15 and the accompanying commentary state that

When vulnerable individuals and groups are considered for recruitment in research, researchers and research ethics committees must ensure that specific protections are in place to safeguard the rights and welfare of these individuals and groups in the conduct of the research.

The account of vulnerability in this Guideline seeks to avoid considering members of entire classes of individuals as vulnerable. However, it is useful to look at the specific characteristics that may render individuals vulnerable, as this can aid in identifying the special protections needed for persons who may have an increased likelihood of being wronged or of incurring additional harm as participants in research. Different characteristics may also co-exist, making some individuals more vulnerable than others. This is highly dependent on the context. For example, persons who are illiterate, marginalized by virtue of their social status or behaviour, or living in an authoritarian environment, may have multiple factors that make them vulnerable [3].

In Australia, The National Statement on Ethical Conduct in Human Research[4] specifically mentions refugees in Chapter 4.3, as persons likely to be in dependent and unequal relationships, thus indicating the complexity inherent in working with disempowered populations.

It is the case that asylum seekers have multiple layers of vulnerability, based upon rights’ deprivation, age, previous experience of torture, sexual violence, gender and family separation. These guidelines set some broad perimeters that are certainly worthy of consideration and, as a framework, they are indeed useful. There is, however, no detail about how we might translate from theory to practice[5].

In particular, they do not help us resolve the conflict between on the one hand obtaining informed consent from those detained, where access is limited, conditions constrain autonomy, and we cannot check for understanding and competence, and on the other the imperative to conduct research. CIOMS guidelines 9 and 10 give explicit direction concerning informed consent and, consistent with many other guidelines, prohibit research without consent unless the benefit is very great and the potential risk very small. On this basis, direct research involving asylum seekers in detention cannot be carried out.

More particularly, Calvin Ho suggests the guidelines do not go far enough in addressing situational and structural contributions to vulnerability[6]. These leave researchers working in situations where there is great structural as well as personal vulnerability for participants to find creative ways to uncover, record and analyse injustices that might otherwise be hidden from public view, and from mechanisms of accountability. We encourage researchers to find ways of creating and utilising all forms of data, such as published reports, newspaper articles, and interviews with those who have knowledge but are less vulnerable, without ever compromising the importance of informed consent.

How should both researchers and those engaged in ethics review think about these complex issues? The first issue relates to informed consent, especially when asylum seekers are incarcerated, and speaks to whether or not powerless people, even when fully competent, can give informed consent. We also encourage researchers to find a way to fulfil research imperatives that promote justice for highly vulnerable populations wherever possible, through gathering data in ways that do not compromise those who are already highly vulnerable[7].

For our own part, over 14 years we collected a considerable number of interviews from healthcare providers, including rich descriptive accounts of detention life and the way in which the right to health was, and continues to be undermined. These were matched with every other source available. We have built up a very complex picture of life in onshore detention as well as on Manus Island and Nauru. While things continue to deteriorate, it is not possible for people to pretend these events did not take place.

There were two other important outcomes. The first was that healthcare providers could utilise our work when making decisions about whether to work in asylum seeker detention and, if so, the ethical implications of their choice. The second was that those who spoke to us became witnesses to the suffering they had seen. Their participation therefore became an act of solidarity for those who could not speak for themselves. As David Robertson et al. state:

[Witnessing] entails being with people who are victims of injustice or violence and thereby showing that they have not been abandoned… it entails testifying to the outside world about the injustice or violence observed, and advocating that the world community bring about change. Bearing witness can thus facilitate and fuel human solidarity in the face of tragedy, and contribute to focussing international attention.[8]

Notes

[1] CIOMS, International ethical guidelines for health-related research involving humans, 2016. https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf

World Medical Association, Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects,2018.https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/\

[2]  World Medical Association, ibid.

 

[3] CIOMS, ibid.

 

[4] NHMRC, The National Statement on Ethical Conduct in Human Research, 2007. Updated 2015. https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e72_national_statement_may_2015_150514_a.pdf

 

[5] Such guidance is provided elsewhere, for example by the European Commission in its Guidance Note on Research on refugees, asylum seekers and migrants. See http://ec.europa.eu/research/participants/data/ref/h2020/other/hi/guide_research-refugees-migrants_en.pdf

 

[6] Calvin Ho, CIOMS guidelines remain conservative about vulnerability and social justice, Indian Journal of Medical Ethics, June, 2017.

 

[7] Such strategies might be included in submissions to the NHMRC’s consultation on the National Statement Part 4. See https://ahrecs.com/resources/nhmrc-invitation-to-provide-feedback-to-inform-a-review-of-section-4-of-the-national-statement-on-ethical-conduct-in-human-research

 

[8] David Robertson et al. What kind of evidence do we need to justify humanitarian medical aid? The Lancet, 360, no.9329, 2002, pp.330- 333. DOI: https://doi.org/10.1016/S0140-6736(02)09558-2

 

Disclosure of interest
I declare I have no conflict of interest.

Contributor
See above

This post may be cited as:
Zion D. (30 March 2018) On the Problem of “Wordlessness”. Do The Declaration of Helsinki and the Council for International Organizations of Medical Science Guidelines Protect the Stateless in the Research Context?. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/on-the-problem-of-wordlessness-do-the-declaration-of-helsinki-and-the-council-for-international-organizations-of-medical-science-guidelines-protect-the-stateless-in-the-research-con

Hints for Using Worked Examples in Training Sessions0

 

First of all a frank acknowledgement by the AHRECS team – In the past we’ve merrily used invented applications/vignettes, sometimes with deliberately inserted defects, and de-identified real proposals (with permission) in the professional development activities we’ve facilitated. We did so as a way to help research ethics reviewers and researchers (but reviewers made up the overwhelming majority of these workshops) to spot mistakes and in doing so demonstrating they understood an ethical principle or a specific provision of a statement/code/policy. At the time we might even have congratulated ourselves on providing a real world practical activity rather than merely telling attendees what they should do.
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A couple of years ago each of us drew the same conclusion and were horrified – The use of ‘can you find the hidden flaw’ exercises was part of the reason for the adversarial climate between researcher and research ethics reviewers. They reinforce the message that the job of a research ethics review body is to find what’s wrong with a project, that members are being effective if they find something other members may have missed and that they should expect to find ethical defects: that is, an (unwarranted) assumption that participants need to be protected from researchers.
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As Jim notes, examples can be used positively in professional development activities for research ethics reviewers and researchers. Such activities can be used as a way to focus on congratulating researchers for novel or elegant solutions to ethics challenges, on facilitating rather than policing research, and how to achieve best practice in review feedback.
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Such examples should be used in all our professional development strategies.
The use of defective examples is dead. Long like the use of positive examples. 

Training sessions for new ethics committee members and new researchers frequently use a completed application as a fully-worked example of how to practically implement legislation, codes, and administrative processes.  There is now a solid body of scientific findings that can guide the effective use of worked examples in promoting learning and its generalisation to new situations.1  Based on these findings, here are three evidence-based hints:

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(1) Walk trainees through at least two completed ethics applications for related projects.  According to the available research, a single example will most likely cause new committee members to see it as an ideal exemplar that all applications must conform to.  Similarly, new researchers will tend to see a single example as an ideal template.  They may try to squeeze all their information into that template even if it metaphorically means pounding square pegs into round holes.  Enabling trainees to study, compare, and contrast two or worked examples dramatically increases understanding of the underlying principles and, more importantly, the ability to see analogies between the examples and new applications.2
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(2) The initial worked examples should be correct, particularly for new members and researchers who are not yet familiar with the legislation, codes, and administrative processes.  As familiarity increases, test cases with deficiencies can then be introduced for study and facilitated discussion.
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(3) The projects described in initial examples should be relatively simple while still being authentic.  Then, as understanding and skill increases, more complex worked examples and test cases can be introduced.4
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Given that the time allocated to a training session may be limited to a few hours, readers may wonder how they are going to find the time for extensively using examples while still covering the principles in the legislation, codes, and administrative procedures.  One way to free up time and promote a better linkage of the principles to ethics applications is to convert a lecture-based “just-in-case” approach to learning to an experiential, trainee-centred, “just-in-time” mode.  This conversion can be accomplished by providing a short (5-10 min) introduction that orients the audience to the main points to be covered.  Then, the principles can be brought out in facilitated discussions at relevant points during walk-throughs of the examples and test cases.
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  1. Renkl A: Toward an instructionally oriented theory of example-based learning. Cognitive Science 2014;38(1):1-37.
  2. Gentner D, Holyoak KJ: Reasoning and learning by analogy: Introduction. American Psychologist 1997;52:32-4.
  3. Stark R, Kopp V, Fischer MR: Case-based learning with worked examples in complex domains: Two experimental studies in undergraduate medical education. Learning and Instruction 2011;21(1):22-33.
  4. Paas F, Van Merrienboer J, Van Gog T. Designing instruction for the contemporary learning landscape. In: Harris IKR, Graham S, Urdan T, editors. APA Educational Psychology Handbook: Vol 3 Application to Learning and Teaching Washington: American Psychological Association; 2011. p. pp. 335-57.
    http://ro.uow.edu.au/cgi/viewcontent.cgi?article=1688&context=edupapers

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Disclosure of interests

I have no conflict of interest

Contributor
James Kehoe, PhD FRSN
Jim is a Professor of Psychology, UNSW, where his 49-year research career has spanned many areas of learning, memory, and training.  He has served as chair of the Animal Care and Ethics Committee and convener of the Human Research Ethics Advisory Panel (Behavioural Sciences)
Jim’s UNSW staff profileejameskehoe@gmail.com

This post may be cited as:
Kehoe J. (26 March 2018) Hints for Using Worked Examples in Training Sessions. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/hints-for-using-worked-examples-in-training-sessions

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