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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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

Disaster Research and its Ethical Review1

 

Disaster research ethics is a growing area of interest within the research ethics field. Given the lack of a universal definition of disasters, it should not be a surprise that disaster research ethics is defined in various ways. Early approaches focused on ethical issues in conducting research in the acute phase of disasters (O’Mathúna 2010). Given the similarities of some of the ethical issues, it came to include humanitarian crises and emergencies. A recent review combined mental health research in natural disasters, armed conflicts and the associated refugee and internally displaced persons (IDP) settings (Chiumento et al. 2017). Each of these settings raises distinct ethical issues, as well as practical challenges for those ethically reviewing disaster research. The 2016 revision of the Council for International Organizations of Medical Sciences (CIOMS) research ethics guidelines included a section on disaster research (https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf). This blog will highlight a few of the practical challenges and note some efforts to respond to these.

One issue is how some disasters happen suddenly, while research ethics review takes time. The 2016 CIOMS guidelines call for innovative approaches to research ethics review, including ways to pre-assess protocols so that they can be reviewed rapidly once a relevant disaster occurs. As committees develop ways to adapt to disaster research, other review practices can be examined to identify innovative approaches to the challenges.

A key ethical issue to address with disaster research is whether a particular project should be conducted at this time with these particular participants. In the most immediate phase of an acute disaster, resources and energy should be focused on search and rescue. Researchers could hinder this, or divert scarce resources. At the same time, data should be collected as soon as possible to contribute to the evidence based for first responders. Ethics review committees should ensure justifications are provided for why a project needs to be done during the acute phase. Questions also need to be asked about whether disaster survivors have more important needs than to participate in research. For example, some have questioned whether children who survive war should be asked to participate in research when there are few resources available to help them with the mental health challenges of surviving war (Euwema et al. 2008).

With the move towards a more evidence-based approach to humanitarian work, international and non-governmental organisations (NGOs) are increasingly engaging in research and other evaluation programmes. Some of these organisations may have little experience with research or research ethics, and hence need additional support in developing and conducting projects. Much debate has occurred over what ‘counts’ as research and is therefore required to undergo formal research ethics approval. Rather than asking if a project is research or not, it is more important to identify the ethical issues in the project and ensure they are being addressed as carefully and thoroughly as possible (Chiumento et al. 2017). Needs assessments, projects that monitor or evaluate programmes, public health surveillance, and many other activities raise ethical issues whether or not they are formal academic research studies. At the same time, every project does not need to submit the same sort of detailed research ethics application as a randomised control trial of an experimental drug. Some sort of ethical evaluation should be conducted, and here again there is an opportunity to be innovative. Different formal and informal review mechanisms could be developed to support groups conducting different types of projects. The key concern should be that the ethical issues are being examined and addressed.

Also key here is that people in the communities from which participants will be sought are involved from the design of the project (O’Mathúna 2018). Too many ‘parachute projects’ have been conducted (some with ethical approval) whereby the project is designed completely by outsiders. Once everything has been decided, the team approaches the community only to identify a lack of interest in participating or that certain ethical challenges have been overlooked. Research in other cultures, especially in the midst of armed conflicts, is especially prone to such challenges. Review committees may need to encourage exploratory discussions between researchers and participant communities, or seek evidence of how such discussions have gone.

Unexpected ethical issues often arise in disaster research given the instability and complexity of its settings (O’Mathúna & Siriwardhana 2017). An approach where ethics review bodies give approval to projects and then have little or no engagement other than an annual report is especially inadequate in disasters. Researchers may be forced to make changes in fluid settings, or may encounter unexpected issues. Submitting amendments may not be practical or fast enough, when what is needed is advice and direction from those with research ethics expertise. Thus, initiatives are being developed to provide “on call” ethics advice.

This points to how disaster research often requires additional support and protection for researchers than other types of research. Researchers may enter danger zones (natural or violent) and may see or learn of horrors and atrocities. Researchers can be subjected to physical dangers or traumatised psychologically.. In addition to the normal stresses of conducting research, these additional factors can lead to mistakes and even ethical corner-cutting. Therefore, review committees need to carefully investigate how the physical and mental well-being of researchers will be protected and supported.

These are some examples of how research ethics needs to go beyond approval processes to mechanisms that promote ethical decision-making and personal integrity during research. One such project in which I am involved is seeking insight from humanitarian researchers into the ethical issues experienced in the field (http://PREAportal.org). We are also conducting a systematic review of such issues and collecting case studies from researchers. The goal is to produce a practical tool to facilitate learning lessons from disaster researchers and promote ethical decision-making within teams.

The world is increasingly experiencing disasters and conflicts and huge amounts of resources are put into responses. Some of these resources are put towards evaluating disaster responses, and developing evidence to support disaster responders. We can expect disaster research to increase and to be increasingly seen by research ethics committees. It is therefore important that ethics committees prepare themselves to respond to the ethical challenges that disaster research raises.

References

Chiumento, A., Rahman, A., Frith, L., Snider, L., & Tol, W. A. (2017). Ethical standards for mental health and psychosocial support research in emergencies: Review of literature and current debates. Globalization and Health 13(8). doi 10.1186/s12992-017-0231-y

Euwema, M., de Graaff, D., de Jager, A., & Kalksma-Van Lith, B. (2008). Research with children in war-affected areas. In: Research with Children, Perspectives and Practices, 2nd edition. Eds. Christensen, P. & James, A. Abingdon, UK: Routledge; 189-204.

O’Mathúna, D.  (2010). Conducting research in the aftermath of disasters: Ethical considerations. Journal of Evidence-Based Medicine 3(2):65-75.

O’Mathúna, D. (2018). The dual imperative in disaster research ethics. In: SAGE Handbook of Qualitative Research Ethics. Eds. Iphofen, R. & Tolich M. London: SAGE; 441-454.

O’Mathúna, D., & Siriwardhana, C. (2017). Research ethics and evidence for humanitarian health. Lancet 390(10109):2228-9.

Declaration of interests

Dónal O’Mathúna has been involved in research ethics for over twenty years. He was chair of the Research Ethics Committee at Dublin City University (DCU) for six years. In addition to his joint position at DCU and The Ohio State University, he is Visiting Professor of Ethics in the European Master in Disaster Medicine, Università del Piemonte Orientale, Italy. His research interests focus on ethical issues in disasters, in particular disaster research ethics. He was Chair of the EU-funded COST Action (2012-2016) on Disaster Bioethics (http://DisasterBioethics.eu) and is the Principal Investigator on the R2HC-funded research project, Post-Research Ethics Analysis (http://PREAportal.org).

Contributor
Dónal O’Mathúna, PhD
Associate Professor, School of Nursing & Human Sciences, Dublin City University, Ireland
Associate Professor, College of Nursing, The Ohio State University, Columbus, Ohio, USA
Dónal’s DCU profiledonal.omathuna@dcu.ie
Twitter: @domathuna
http://BioethicsIreland.ie

This post may be cited as:
O’Mathúna D. (2018, 26 February 2018) ‘Disaster Research and its Ethical Review’. Research Ethics Monthly. Retrieved from https://ahrecs.com/human-research-ethics/disaster-research-ethical-review

Ethical Use of Student Data in Higher Education – Advancing the conversation1

 

In a 2016 conference paper discussing ethical use of student data I noted that there was a ‘disconnect between national and international perspectives of the importance of institutional policy and guidelines regarding ethical use of student data, and the perceptions of academics about these guidelines’ (Jones, 2016, p300). I suggested that one strategy for bridging this divide was for conversations to be held both within and between institutions with an aim of informing and enhancing learning and teaching practice and culture. This post provides an overview of some of the conversations that have occurred in this area in the last 12 months in Australasia, particularly through the Australasian Society for Computers in Learning in Tertiary Education (ASCILITE).

First though, my interpretation of the phrase ‘ethical use of student data’. To me, and I am sure many others, this is much more than applying for, and being granted, clearance from your institution’s Human Research Ethics Committee. Certainly, this is an important step if you are intending to disseminate your findings as research and publish, and is sometimes a step that academic staff can overlook if research in their discipline does not normally involve ethics approval, or they do not consider this as they are not directly researching students, just their data. Ethical use also considers:

  • Protection of student privacy
  • Conversations with students regarding reasons for collection and use of data
  • Ensuring that data is used for informing and enhancing practice and the student experience
  • Obtaining consent from students; or, at least, informing students how and why their data will be used

The ability for students to ‘opt out’ of any data collection is a sensitive issue as there are some circumstances, for example, research into online discussion forums where this could adversely affect the research if students were given this option. This is just one aspect that needs further conversations and development of policy and guidelines.

ASCILITE is considered a leading organisation in the southern hemisphere for staff working in tertiary education in ‘fields associated with enhancing learning and teaching through the pedagogical use of technologies’ (ASCILITE, 2014) and as such is well placed to be leading the cross-institutional conversation on ethical use of student data. In 2017 some of the ways these conversations were facilitated included

  • Learning Analytics Special Interest Group ran a series of webinars with one facilitated by Paul Prinsloo having the topic of Responsible Learning Analytics: A Tentative Proposal
  • The 2017 ASCILITE Conference included an Exploratory Panel Session discussing ‘emerging ethical, legal, educational, and technological issues surrounding the collection and use of student data by universities, and the impact these strategies have on student trust and privacy.’
  • The Learning Analytics SIG also held a panel session discussing scenarios for Utopian/Dystopian future in regards to Learning Analytics

However, there was only one submitted paper with reference to ethical use of data (Brooker, Corrin, Mirriahi & Fisher, 2017). Similarly for the upcoming Learning Analytics Knowledge conference (LAK18), only one paper has any reference to ethics in the title, and at the 2017 conference there was one session with 3 papers. This suggests that whilst national and international bodies are promoting the conversations, there is still a way to go before these happen widely within institutions. Are there other organisations that are facilitating similar discussions?

Whilst promoting these conversations is a useful first step, there is also a need to continue to develop guidelines and processes. These will help ensure that staff are submitting ethics applications and their work with student data is conducted in an ethical manner. Additionally, Human Ethics staff need to work alongside academics and Learning & Teaching support staff; journals and conferences need to ensure that appropriate ethics approvals have been obtained and institutions need to involve students in all facets of Learning Analytics. These strategies will promote more widespread adoption of ethical practices in use of student data to inform and enhance learning and teaching practice and culture, and, ultimately, the student experience. Hopefully initiatives such as those outlined in this post will continue to grow and spark the necessary conversations – who will join us?

References

ASCILITE (2014) About ASCILITE. Retrieved from http://ascilite.org/about-ascilite/

Brooker, A., Corrin, L., Mirriahi, N. & Fisher, J. (2017). Defining ‘data’ in conversations with students about the ethical use of learning analytics. In H. Partridge, K. Davis, & J. Thomas. (Eds.), Me, Us, IT! Proceedings ASCILITE2017: 34th International Conference on Innovation, Practice and Research in the Use of Educational Technologies in Tertiary Education (pp. 27-31). Retrieved from http://2017conference.ascilite.org/wp-content/uploads/2017/11/Concise-BROOKER.pdf

Jones, H. (2016). Ethical considerations in the use of student data: International perspectives and educators’ perceptions. In S. Barker, S. Dawson, A. Pardo, & C. Colvin (Eds.), Show Me The Learning. Proceedings ASCILITE 2016 Adelaide (pp. 300-304). Retrieved from http://2016conference.ascilite.org/wp-content/uploads/ascilite2016_jonesh_concise.pdf

Declaration of Interests

Hazel Jones is a member of the ASCILITE Executive Committee and one of the facilitators for the Learning Analytics SIG.

Contributor
Hazel Jones
PhD candidiate/Educational Designer | University of Southern Queensland | USQ Staff ProfileHazel.Jones@usq.edu.au

This post may be cited as:
Jones H. (2018, 22 February 2018) ‘Ethical Use of Student Data in Higher Education – Advancing the conversation’. Research Ethics Monthly. Retrieved from https://ahrecs.com/human-research-ethics/ethical-use-student-data-higher-education-advancing-conversation

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