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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

How a simple ‘thank you’ could improve clinical trials – Nature (Editorial | November 2018)0

Posted by Admin in on December 11, 2018
 

Everyone would benefit if researchers did more to make participants feel part of a study.

When researchers at the drug giant Pfizer wanted to improve their clinical trials, the people who had taken part had a clear suggestion: researchers should say thank you.

It is a simple request, but a revealing one. When a clinical trial is completed, many participants walk away empty-handed. Most never hear from the investigators or the trial’s sponsor again. Many do not learn the results of the study in which they took part. It’s not good enough — and it indicates a deeper problem.

As we discuss in a News Feature this week, clinical-trial participants and the people who care for them are increasingly seen as partners in research. They are more informed than ever about their conditions and their medical options. And they are demanding — and receiving — more of a say in how clinical trials are designed and conducted. Some of this activity has been boosted by social media, which has allowed people with medical conditions and their carers to band together, share their experiences and advocate for change.

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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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(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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(US) Participants In Rogue Herpes Vaccine Research Take Legal Action – KHN (Marisa Taylor | March 2018)0

Posted by Admin in on October 20, 2018
 

Three people injected with an unauthorized herpes vaccine by a Southern Illinois University researcher have filed suit against his company, demanding compensation for alleged adverse side effects from the experiments.

SIU professor William Halford, who died in June, had injected Americans with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without safety oversight that is routinely performed by the Food and Drug Administration or an institutional review board.

Two of the participants who filed the lawsuit, Elizabeth Erkelens and Ed Biel, received the vaccine in the Caribbean trial, according to the lawsuit. The third participant, Terry Graham, was injected in two Illinois hotel rooms, it states.

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About the lawyer Alan C. Milstein