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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Why do medical journals keep taking authors at their word? – STAT (Ivan Oransky | September 2018)0

Posted by Admin in on November 29, 2018
 

The recent revelation that a leading official at Memorial Sloan Kettering Cancer Center failed for years to disclose lucrative financial conflicts of interest might have been surprising in its scale. But it’s old news that many researchers aren’t fully transparent when it comes to their financial relationships with industry.

So why should we keep up the charade? And why, given the clarity of the problem, do medical journals continue to take authors at their word — only to wind up looking like dupes?

According to an investigation by ProPublica and The New York Times, Dr. José Baselga — who was chief medical officer of the venerable cancer clinic until resigning Thursday — has what can charitably be described as an inconsistent personal policy on revealing companies that have given him cash or other potentially lucrative fillips. Baselga also has stayed mum about his conflicts of interest — which also involve research funding and seats on advisory boards — in many of his publications, including those in high-rent titles like the New England Journal of Medicine, and despite policies from the journals demanding that authors reveal such relationships.

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Patients find misleading information on the internet – The Ethics Blog (Pär Segerdahl | October 2018)0

Posted by Admin in on November 25, 2018
 

In phase 1 clinical studies of substances that might possibly be used to treat cancer in the future, cancer patients are recruited as research participants. These patients almost always have advanced cancer that no longer responds to the standard treatment.

That research participation would affect the cancer is unlikely. The purpose of a phase 1 study is to determine safe dosage range and to investigate side effects and other safety issues. This will then enable proceeding to investigating the effectiveness of the substance on specific forms of cancer, but with other research participants.

Given that patients often seek online information on clinical trials, Tove Godskesen, Josepine Fernow and Stefan Eriksson wanted to investigate the quality of the information that currently is available on the internet about phase 1 clinical cancer trials in Sweden, Denmark and Norway.

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(US) ER patients given ketamine, other powerful drugs in clinical trials without their consent, FDA finds – STAT (Sharon Begley | October 2018)0

Posted by Admin in on November 15, 2018
 

Minneapolis hospital tested powerful antipsychotics and the potent anesthetic ketamine on emergency room patients without their knowledge or consent, violating regulations on human research, federal inspectors have determined.

Based on those findings, a health watchdog group on Monday urged federal regulators to suspend all clinical trials at the hospital. In a letter to the Food and Drug Administration and the Department of Health and Human Services office that protects human research subjects, Public Citizen also called for regulators to immediately launch an investigation into the conduct and oversight of the studies and “impose severe sanctions for the serious ethical and regulatory lapses that have occurred in the ketamine clinical trials and other studies” at Minneapolis’s Hennepin County Medical Center.

The hospital committee that green-lighted the studies, called an institutional review board (IRB), “appears incapable of doing its job,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group, who organized the letter. It acted unethically and placed patients in danger, he said, “including by waiving the requirement for informed consent in situations where that is not allowed.”

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(Egypt) Debate over misconduct stalls Egyptian clinical trials law – Sci Dev Net (Hazem Badr | October 2018)0

Posted by Admin in on November 11, 2018
 

[Cairo] Egypt’s president Abdel Fattah El-Sisi has declined to sign the country’s clinical trials law into action, after objecting to parts that, he said, might violate the human body.

Despite the delays with the Egyptian new clinical trials law, with its legal penalties for failure to meet human research ethics and research integrity standards there are indications and commentary that suggest the delay reflects a political engagement many of us would like to see in our own countries.

According to researchers following the law’s creation, Sisi returned seven amendments to the law, which could delay its creation. For example, articles 28, 29 and 32 of the law have been amended to reduce the severity of proposed prison terms for misconduct, such as using human samples without informed consent.
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But the scientists following the law’s creation are positive about the president’s response, saying that his amendments show he is engaging with the matter and keen to see the law signed into life. “The president’s comments address the complex equation of respecting the sacredness of the human body and, at the same time, endorsing scientific research,” said Mahmoud Sakr, the director of Egypt’s Academy of Scientific Research and Technology.
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“The text [as it stands] contradicts our goal of motivating universities to pursue joint research and hinders the exploration of samples using advanced equipment that might not be available locally,”
……Abdel Fattah El-Sisi, Egypt’s president
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