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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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(Queensland, Australia) Ex-judge to investigate controversial marine research – Times Higher Education (John Ross | January 2020)0

Posted by Admin in on January 11, 2020
 

An Australian university has launched an investigation into the research record of a discredited scientist it educated, as findings by academics who supervised her doctoral training are challenged.

James Cook University said it has appointed an external panel to look for evidence of misconduct in the research conducted by marine biologist Oona Lönnstedt between 2010 and 2014, when she was undertaking PhD studies at the Queensland institution.

The university said the panel’s as yet unidentified members include “eminent academics with expertise in field work, marine science and ethics” and a former federal court judge.

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China Uses DNA to Map Faces, With Help From the West – New York Times ( Sui-Lee Wee & Paul Mozur | December 2019)0

Posted by Admin in on January 9, 2020
 

TUMXUK, China — In a dusty city in the Xinjiang region on China’s western frontier, the authorities are testing the rules of science.

Does your institutional guidance material speak to situations such as this, including secondary use that could present a risk to a population of people?  Do you have mechanisms to manage institutional conflicts of interest?  If not, this story highlights why such arrangements could be important.

With a million or more ethnic Uighurs and others from predominantly Muslim minority groups swept up in detentions across Xinjiang, officials in Tumxuk have gathered blood samples from hundreds of Uighurs — part of a mass DNA collection effort dogged by questions about consent and how the data will be used.
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In Tumxuk, at least, there is a partial answer: Chinese scientists are trying to find a way to use a DNA sample to create an image of a person’s face.
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The technology, which is also being developed in the United States and elsewhere, is in the early stages of development and can produce rough pictures good enough only to narrow a manhunt or perhaps eliminate suspects. But given the crackdown in Xinjiang, experts on ethics in science worry that China is building a tool that could be used to justify and intensify racial profiling and other state discrimination against Uighurs.
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(US) This Researcher Exploited Prisoners, Children, and the Elderly. Why Does Penn Honor Him? – The Chronicle of Higher Education (Alexander Kafka, | November 2019)0

Posted by Admin in on December 29, 2019
 

Albert M. Kligman was a larger-than-life dermatologist and entrepreneur instrumental in inventions that brought riches to him and his university. He also performed torturous experiments.

Over the last 12 years we have shared a few pieces about egregious ethical breaches, but we aren’t sure what stunned us most, what was done to those vulnerable Americans or that the track record of the lead researcher is still being celebrated.

“An outstanding clinician, researcher, and educator.” “A visionary leader” who led “an extraordinary life.” That’s how the University of Pennsylvania describes Albert M. Kligman on a fund-raising page for a lectureship in his name. He is also honored by not one but two chaired professorships.
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What the university calls his “pioneering work with Retin-A” was estimated by a student turned critic of Kligman, Bernard Ackerman, as generating in the “many tens of millions.” Kligman himself once described to a television interviewer the sales of the acne medicine as an “explosion …a very considerable sum of money that comes to our department in the form of royalties. We are swimming in cash.”
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