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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(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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Research Ethics in an Unethical World: The Politics and Morality of Engaged Research (Claudio Morrison and Devi Sacchetto | October 2017)0

Posted by Admin in on January 14, 2020
 

Abstract
This article explores ethical dilemmas in researching the world of work. Recent contributions to Work, employment and society have highlighted challenges for engaged research. Based on the emancipatory epistemologies of Bourdieu, Gramsci and Burawoy, the authors examine moral challenges in workplace fieldwork, question the assumptions of mainstream ethics discourses and seek to identify an alternative approach. Instead of an ethics premised on a priori, universal precepts that treasure academic neutrality, this article recognises a morality that responds to the social context of research with participation and commitment. The reflection in this study is based on fieldwork conducted in the former Soviet Union. Transformation societies present challenges to participatory ethnography but simultaneously provide considerable opportunities for developing an ethics of truth. An approach that can guide engaged researchers through social conflict’s ‘messy’ reality should hinge on loyalty to the emancipation struggles of those engaged in it.

Keywords
business and management research, ethics, materialism, post-socialism, qualitative fieldwork, workplace morality

Morrison, C., & Sacchetto, D. (2018). Research Ethics in an Unethical World: The Politics and Morality of Engaged Research. Work, Employment and Society, 32(6), 1118–1129. https://doi.org/10.1177/0950017017726947
Publisher: https://journals.sagepub.com/doi/abs/10.1177/0950017017726947#articleCitationDownloadContainer

Google health-data scandal spooks researchers – Science (Heidi Ledford | November 2019)0

Posted by Admin in on January 12, 2020
 

Scientists fear the controversy over the Nightingale project will undermine trust in research.

Google and one of the largest health-care networks in the United States are embroiled in a data-privacy controversy that researchers fear could jeopardize public trust in data-sharing practices and, potentially, academic studies.

At issue is a project dubbed Nightingale that gives Google access to the health-care information, including names and other identifiable data, of tens of millions of people without their knowledge. The people were treated at facilities run by the health network Ascension, which is based in St Louis, Missouri.

Google says that Nightingale, first reported in The Wall Street Journal on 11 November, is meant to develop technology that would enable Ascension to deliver improved health care.

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Russian journals retract more than 800 papers after ‘bombshell’ investigation – Science (Dalmeet Singh Chawla | January 2020)0

Posted by Admin in on January 11, 2020
 

Academic journals in Russia are retracting more than 800 papers following a probe into unethical publication practices by a commission appointed by the Russian Academy of Sciences (RAS). The moves come in the wake of several other queries suggesting the vast Russian scientific literature is riddled with plagiarism, self-plagiarism, and so-called gift authorship, in which academics become a co-author without having contributed any work.

The RAS commission’s preliminary report documenting the problems and journals’ responses to them is “a bombshell,” says Gerson Sher, a former staffer at the U.S. National Science Foundation and the author of a recent book on U.S.-Russia science cooperation. The report, released yesterday, “will reinforce the suspicions and fears of many—that their country is not going down the right path in science and that it’s damaging its own reputation,” says Sher, who applauds RAS for commissioning the investigation.
Russia’s roughly 6000 academic journals, the vast majority published in Russian, are popular among the country’s academics. A 2019 study found that Russian authors publish far more in domestic journals than, for instance, their counterparts in Poland, Germany, or Indonesia. But standards are often low. In March 2018, for instance, Dissernet, a network aimed at cleaning up the Russian literature, identified more than 4000 cases of plagiarism and questionable authorship among 150,000 papers in about 1500 journals.
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