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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Research intelligence: how to sniff out errors and fraud – Times Higher Education (Jack Grove | January 2020)0

Posted by Admin in on January 27, 2020
 

A growing number of data detectives are on the hunt for sloppy science and dodgy statistics. Jack Grove examines the methods they use

These days it is not just co-authors or peer reviewers who are checking journal papers for errors: a growing number of self-appointed fraud busters are scanning scientific literature for flaws.

This unpaid and mostly anonymous endeavour has led to the retractions of hundreds of papers and even disciplinary action where wrongdoing is exposed.

So how can scholars catch errors when reviewing others’ papers, or when double-checking their own work or that of collaborators?

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Evaluating ethics oversight during assessment of research integrity (Papers: Andrew Grey, et al | November 2019)0

Posted by Admin in on January 24, 2020
 

Abstract
We provide additional information relevant to our previous publication on the quality of reports of investigations of research integrity by academic institutions. Despite concerns being raised about ethical oversight of research published by a group of researchers, each of the four institutional investigations failed to determine and/or report whether ethics committee approval was obtained for the majority of publications assessed.

Grey, A., Bolland, M. & Avenell, A. (2019) Evaluating ethics oversight during assessment of research integrity. Research Integrity and Peer Review 4, 22 (2019). https://doi.org/10.1186/s41073-019-0082-6
Publisher (Open Access): https://researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-019-0082-6

There’s ‘consent’ and then there’s consent: Mobilising Māori and Indigenous research ethics to problematise the western biomedical model (Papers: Kiri West-McGruer | January 2020)0

Posted by Admin in on January 23, 2020
 

Abstract

A fascinating recent paper from New Zealand reflecting on Māori research ethics, consent, First People, collective outlooks, sociology, big data and genuine respect

Challenging western research conventions has a strong documented history in Indigenous critical theory and Kaupapa Māori research discourse. This article will draw from the existing research in these fields and expand on some of the core critiques of the biomedical model in Māori research environments. Of interest are the tensions produced by an over-reliance on individual informed consent as the panacea of ethical research, particularly when the research concerns communities who prioritise collective autonomy. These tensions are further exacerbated in research environments where knowledge is commodified and issues of knowledge ownership are present. Continuing a critique of the informed consenting procedure, this article considers its role in emulating a capitalist exchange of goods and perpetuating a knowledge economy premised on the exploitation of Indigenous people, resources and knowledge. Finally, this article will consider emerging ethical concerns regarding secondary data use in an era of big data.
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Keywords
Informed consent, collective autonomy, Māori research ethics, western biomedical model, scandal and response

West-McGruer, K. (2020). There’s ‘consent’ and then there’s consent: Mobilising Māori and Indigenous research ethics to problematise the western biomedical model. Journal of Sociology. https://doi.org/10.1177/1440783319893523
Publisher: https://journals.sagepub.com/doi/abs/10.1177/1440783319893523
ResearchGate: https://www.researchgate.net/publication/338556502_There’s_’consent’_and_then…

(US) FDA and NIH let clinical trial sponsors keep results secret and break the law – Science (Charles Piller | January 2020)0

Posted by Admin in on January 21, 2020
 

For 20 years, the U.S. government has urged companies, universities, and other institutions that conduct clinical trials to record their results in a federal database, so doctors and patients can see whether new treatments are safe and effective. Few trial sponsors have consistently done so, even after a 2007 law made posting mandatory for many trials registered in the database. In 2017, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) tried again, enacting a long-awaited “final rule” to clarify the law’s expectations and penalties for failing to disclose trial results. The rule took full effect 2 years ago, on 18 January 2018, giving trial sponsors ample time to comply. But a Science investigation shows that many still ignore the requirement, while federal officials do little or nothing to enforce the law.

Failing to report the results of clinical trials have two serious consequences: 1. It can hide from clinicians and other health professionals problems with a new agent/device/technique. 2. It is wasteful of time/resources because other reseachers might try to conduct the same trial, not realising it had already failed.  So it is very concerning these two regulatory agencies are failing to enforce the law.

Science examined more than 4700 trials whose results should have been posted on the NIH website ClinicalTrials.gov under the 2017 rule. Reporting rates by most large pharmaceutical companies and some universities have improved sharply, but performance by many other trial sponsors—including, ironically, NIH itself—was lackluster. Those sponsors, typically either the institution conducting a trial or its funder, must deposit results and other data within 1 year of completing a trial. But of 184 sponsor organizations with at least five trials due as of 25 September 2019, 30 companies, universities, or medical centers never met a single deadline. As of that date, those habitual violators had failed to report any results for 67% of their trials and averaged 268 days late for those and all trials that missed their deadlines. They included such eminent institutions as the Harvard University–affiliated Boston Children’s Hospital, the University of Minnesota, and Baylor College of Medicine—all among the top 50 recipients of NIH grants in 2019.
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The violations cover trials in virtually all fields of medicine, and the missing or late results offer potentially vital information for the most desperate patients. For example, in one long-overdue trial, researchers compared the efficacy of different chemotherapy regimens in 200 patients with advanced lymphoma; another—nearly 2 years late—tests immunotherapy against conventional chemotherapy in about 600 people with late-stage lung cancer.
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