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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

An Argument for Fewer Clinical Trials (Papers: Kirstin Borgerson 2016)0

Posted by Admin in on December 11, 2016
 

Abstract

The volume of clinical research is increasing exponentially—far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I consider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees (RECs) should prohibit all other, lower-quality research, even when it might appear to meet some minimal ethical standard. Following a close analysis of the social-value requirement of ethical clinical research, I argue that this proposal is defensible.

The problem identified in this paper has two parts, quantity and quality, and some clarification is needed about the latter because “quality” is a highly contested term in the medical literature. When some scholars advocate for high-quality trials, they mean large-scale, simple, explanatory randomized controlled trials. Others, including myself, have defended a different characterization of high-quality research that tends more toward pragmatic trial design and the use of methods other than RCTs. Pragmatic trials aim to provide evidence that directly supports clinical decision-making in “usual” care settings. Unlike explanatory trials, which aim to abstract away from particular settings and patients, in the hopes of creating ideal conditions for the success of an intervention, pragmatic trials deliberately pursue knowledge of high applicability, through the use of representative subjects, clinically important questions, flexible treatment protocols, patient-oriented outcome measures, and so on. I see applicability as a marker of high-quality research. The context in which research is meant to be applied should be the context in which new interventions are evaluated.

Borgerson K (2016) “An Argument for Fewer Clinical Trials,” Hastings Center Report 46 1–11. DOI: 10.1002/hast.637
Publisher: http://onlinelibrary.wiley.com/doi/10.1002/hast.637/full

500+ Resources – Part Two of Nominations of best resources0

Posted by Admin in on December 8, 2016
 

This second nomination of favourite resources is from Associate Professor Lisa Wynn, Department of Anthropology, Macquarie University. Next week we’re going to be sharing some more nominations of people’s nomination of favourite resources? Got your own favourite? Drop us a line to gary.allen@ahrecs.com with your suggestion.

Beall’s list of predatory publishers: Web site | Resource Library entry – As the AHRECs site notes, “the Australian Code for the Responsible Conduct of Research direct that the results of research should only be reported once…. This underlines the importance of the selection of a quality publisher/avenue to ensure the maximum impact for your work.” In other words, if you can only publish your data once, you need to make sure that you’re publishing in the right place! Unfortunately, I’ve seen younger scholars make naive decisions about publishers that have been disastrous for their careers. For example, one recent graduate from another university proudly told me that a publishing house had sought out him to publish his completely unrevised PhD thesis! Skeptical (because if it sounds too good to be true, it usually is), I checked on Beall’s list and found that it was one of those publishing houses that publish anything, without peer review, publishing on demand at extraordinarily high prices. The outcome is a book that few will ever purchase, a publisher that looks bad on his CV, and this naive student signed over the copyright to this publisher, so now he can’t publish the content of his rich PhD thesis anywhere else. Now I make a practice of warning all my PhD students to check the Beall’s list before they make any publishing decisions.

The University of New Hampshire’s 5 case studies in research ethics: Web site | Resource Library Entry –  Each is a short (~2 pages) summary of a famous recent case of research misconduct. These would be good to teach with; there’s enough ambiguity in each case to lend itself to lively debate, and they’re all real cases featured in news headlines, not hypothetical scenarios.

The In The News section features a lot of interesting links, including a thoughtful WIRED article by Zoltan Boka (web site | Resource Library entry) about Facebook’s attempt to institute its own in-house ethics committee to review research, after the backlash of negative publicity following revelations that Facebook had manipulated its news feed algorithms to study what would happen when people received more positive or negative news items — without getting consent from any of its “research participants” or even informing them that they were being manipulated and studied. As Boka points out, having an entirely in-house ethics committee that are all Facebook employees means its committee will never be impartial and is susceptible to pressures from above to approve research projects that benefit Facebook.
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500+ Resources – Part One of Nominations of best resources0

Posted by Admin in on December 8, 2016
 

This week we hit the mark of 500 great resources in the Resource Library. Over the next few days we’re going to be sharing nominations of people’s nomination of favourite resources? Got your own favourite? Drop us a line to gary.allen@ahrecs.com with your suggestion.

Professor Mark Israel

Hudson M, Milne M, Reynolds P, Russell K and Smith B (2010) Te Ara Tika. Guidelines for Māori research ethics: A framework for researchers and ethics committee members. Final Draft. Available at: http://www.hrc.govt.nz/sites/default/files/Te%20Ara%20Tika%20Guidelines%20for%20Maori%20Research%20Ethics.pdf
AHRECS Resource Library entry

In 2010, Māori members of research ethics committees drafted Te Ara Tika, guidelines for Māori research ethics, for the Health Research Council of New Zealand (Hudson et al., 2010). Māori committee members are charged with responsibility both for acting as ethical reviewers and for acting as guardians and advocates (kaitiaki) for Māori ethical concerns, ethical issues, and interests.

Te Ara Tika calls for tikanga Māori (locally specific Māori protocols and practices) to encourage research that sustains relationships and preserves justice and equity. The authors argued this would be best (but not uniquely) achieved by research that is informed by kaupapa Māori which seeks ‘to restructure power relationships to the point where partners can be autonomous and interact from this position rather than from one of subordination or dominance’ (Bishop, 2008, p. 440). In Te Ara Tika, this is envisaged as research where Māori are significant participants, the research team is typically all Māori, Māori research methodologies are adopted where appropriate, and which produces Māori knowledge. Importantly, Te Ara Tika also considers how research that is not Māori-led might still be informed by ideas of respectful conduct, achieve tangible outcomes for Māori communities, and enable Māori communities to assume power in the research relationship and responsibility for the outcomes of a project.

While drafted with the needs of health and disability research ethics in mind, the framework could be relevant to all research in New Zealand. Sadly, Te Ara Tika has had limited impact there. The document has no formal standing with ethics committees or the Ministry of Health. One of the authors of Te Ara Tika recently described how the document has been marginalized by the HRC in NZ (Tolich and Smith, 2015), and how Māori interests have been reduced to a matter of culture by HDECs (the ‘cultural turn’).

Nevertheless, Te Ara Tika deserves to be taken seriously. It draws on and responds to indigenous values and interests in a way that is quite different from Values and Ethics or GERAIS in Australia and TCPS2 in Canada. Kaupapa Māori offers a well-articulated challenge to the universalist assumptions of much research ethics. It is elegantly constructed and written in a way that helps international and Pākehā readers engage with its ideas and concepts.

Bishop R (2008) Te Kotahitanga: Kaupapa Māori in Mainstream Classrooms. In: Denzin NK, Lincoln YS and Smith LT (eds) Handbook of Critical and Indigenous Methodologies. Los Angeles: Sage, pp. 439-458.

Hudson M, Milne M, Reynolds P, Russell K and Smith B (2010) Te Ara Tika. Guidelines for Māori research ethics: A framework for researchers and ethics committee members. Final Draft. Available at: http://www.hrc.govt.nz/sites/default/files/Te%20Ara%20Tika%20Guidelines%20for%20Maori%20Research%20Ethics.pdf

Tolich, M and Smith, B (2015) The Politicisation of Ethics Review in New Zealand. Auckland: Dunmore.

 

He Tangata Kei Tua Guidelines for Biobanking with Māori0

Posted by Admin in on December 6, 2016
 

Kei tua o te awe māpara he tangata kē, he mā?

Introduction

Māori ethical frameworks recognise that all research in New Zealand is of interest to Māori and outline community expectations of appropriate behavior in research to deliver the best outcomes for Māori. Research contributes to the broader development objectives of society and this endeavor is being supported by biobanking infrastructure. Ethics has a specific role in guiding key behaviours, processes and methodologies used in research. This document outlines a framework for addressing Māori ethical issues within the context of biobanking. It draws on a foundation of mātauranga (Indigenous knowledge) and tikanga Māori (Māori protocols and practices) and will be useful for researchers, ethics committee members and those who engage in consultation or advice about biobanking with Māori in local, regional, national or international settings.

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