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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Trump’s science adviser on research ethics, immigration and presidential tweets – Science (Sara Reardon | April 2019)0

Posted by Admin in on May 18, 2019
 

Five months into the job, Kelvin Droegemeier tells Nature what it’s like to work with the US president.

When meteorologist Kelvin Droegemeier was sworn in as director of the White House Office of Science and Technology Policy (OSTP) in February, he inherited an office that had been without a leader for two years — and became the top science adviser to President Donald Trump.

Trump’s push to cut government spending on research, and his policies on issues such as immigration, have caused controversy in science. Nature spoke to Droegemeier in mid-April — two months into his tenure — about these policies, his plans and what it’s like to work with the president. The interview has been edited for length and clarity.

The number of OSTP staff dropped precipitously during Trump’s first two years in office. What is the situation now?

The lights were definitely on, and there was a lot of work actually getting done. We have people cycle through. Some of them are on detail for a year, so there’s kind of a constant refresh. I have brought additional people on board in some of the areas that I’m going to be working on a little bit more.

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Prominent UCSD eye doctor ‘on leave’ after inewsource investigation – inewsource (Jill Castellano & Brad Racino | April 2019)0

Posted by Admin in on May 14, 2019
 

Dr. Kang Zhang, chief of eye genetics at the University of California San Diego, is “on leave” after an inewsource investigation exposed how the doctor put medical research subjects in harm’s way for years while pulling in millions of federal dollars for the institution.

This case demonstrates why an institution’s monitoring arrangements need to escalate consistent nonadherence and include random audits

In a new development, inewsource obtained an inspection report from the U.S. Food and Drug Administration that detailed more problems with one of Zhang’s studies. The report, compiled in 2016, described one incident in which Zhang poked a hole in a study participant’s eye with a needle, causing a cataract that had to be fixed with surgery.
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The person wasn’t supposed to be enrolled in the study, according to the report, and the injury allegedly occurred because Zhang was in a hurry to take a trip to China.
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(US/UK) Data suggest US, UK universities fall woefully short on reporting clinical trial results – Endpoints News (Natalie Grover | March 2019)0

Posted by Admin in on April 9, 2019
 

Clinical trial data are used by patients, doctors and policymakers to make informed choices about the benefits and safety of interventions — while the methods and results of all trials are crucial to the pace and direction of scientific progress. However, there is a large body of evidence that suggests that completed clinical trials are commonly left unreported, and educational institutions in the United States and the United Kingdom — arguably the two biggest regions that breed the bulk of medical innovation — have emerged as one of the key culprits guilty of these violations.

In the United States, Congress passed a law in 2007 requiring trial sponsors — including universities — to post the results of certain clinical trials on clinicaltrials.gov within a year of trial completion, and a decade later in January 2017 the rule was finalized. Since 2017, 40 leading US universities should have posted the results of 450 clinical trials — but over a third (31%) of those results are missing, according to an analysis by Universities Allied for Essential Medicines (UAEM) in partnership with non-profit research advocacy group TranspariMED.

The violators include some of the most active trial sponsors: For example the MD Anderson Cancer Center, which has only reported 77% of due trials, Mayo Clinic (42%), UC San Francisco (37%), New York University (21%), and Columbia University (17%).

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(US) University of Illinois at Chicago Missed Warning Signs of Research Going Awry, Letters Show – Propublica Illinois (Jodi S. Cohen | March 2019)0

Posted by Admin in on March 31, 2019
 

UIC has played down its shortcomings in overseeing the work of a prominent child psychiatrist, but newly obtained documents show that the school acknowledged its lapses to federal officials.

This story was co-published with The Chronicle of Higher Education and the Chicago Sun-Times.

For a year, the University of Illinois at Chicago has downplayed its shortcomings in overseeing the work of a prominent child psychiatrist who violated research protocols and put vulnerable children with bipolar disorder at risk.

But documents newly obtained by ProPublica Illinois show that UIC acknowledged to federal officials that it had missed several warning signs that Dr. Mani Pavuluri’s clinical trial on lithium had gone off track, eventually requiring the university to pay an unprecedented $3.1 million penalty to the federal government.

UIC’s Institutional Review Board, the committee responsible for protecting research subjects, improperly fast-tracked approval of Pavuluri’s clinical trial, didn’t catch serious omissions from the consent forms parents had to sign and allowed children to enroll in the study even though they weren’t eligible, the documents show.

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