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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(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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Publish and Perish: The Dangers of Being Young and in a Hurry (Papers: James S. Huntley | February 2019)0

Posted by Admin in on April 5, 2019
 

Abstract

Publications in peer-reviewed journals are a key and official requirement for progression to a consultant surgeon post. Paradoxically, a stipulation that should enhance the importance of surgical research may, in fact, contribute to a pressure that is one of the causes of research misconduct. Consultant trainers can go some way to mitigating against this danger with appropriate teaching and an emphasis on the core values surrounding research ethics.

Huntley J S (February 19, 2019) Publish and Perish: The Dangers of Being Young and in a Hurry. Cureus 11(2): e4098. doi:10.7759/cureus.4098
Publisher (Editorial): https://www.cureus.com/articles/17575-publish-and-perish-the-dangers-of-being-young-and-in-a-hurry

This paper about early career researchers in the surgical field make points that hold true across most (sub)disciplines. It points to the importance of having collegiate Research Integrity Advisers, mentors and resources that support practice (rather than just state the rules).  AHRECS would be delighted to assist your institution with that – https://ahrecs.com/our-services.  We’ve included links to 19 great tips for early career researchers and institutions.

(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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On “truly” understanding the risk – The Ethics Blog (Pär Segerdahl | March 2019)0

Posted by Admin in on March 28, 2019
 

Pär SegerdahlIt is a well-known psychological fact that people have great difficulties to understand probabilistic risks. What does it actually mean that the risk of developing breast cancer the next ten years is fifteen percent? In addition to the difficulties of understanding probabilities, mathematical expressions can cause a false appearance of exactitude and objectivity. It is often about uncertain evaluations, but expressed in seemingly definitive figures.

At our Monday seminar, Ulrik Kihlbom discussed another difficulty with understanding risk information. It can be difficult to understand not only the probabilities, but also what it is you risk experiencing. Sometimes, people face enormously complex choices, where the risks are high, but also the benefits. Perhaps you suffer from a serious disease from which you will die. However, there is a treatment, and it may work. It is just that the treatment has such severe side effects that you may die even from the treatment.

Ulrik Kihlbom interviewed physicians treating patients with leukemia. The doctors stated that patients often do not understand the risks of the treatment they are offered. The difficulty is not so much about understanding the risk of dying from the treatment. The patients understand that risk. However, the doctors said, no one who has not actually seen the side effects understand that the treatment can make you so incredibly ill.

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