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Animal Ethics Biosafety Human Research Ethics Research Integrity

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

Posted by saviorteam in Human Research Ethics, Research Integrity on November 11, 2018
Keywords: Authorship, Beneficence, Biomedical, Biospecimens, Breaches, Clinical trial, Consent, Data management, Honesty, Human research ethics, Institutional responsibilities, International, Medical research, Protection for participants, Publication ethics, Research integrity, Research Misconduct, Researcher responsibilities, Respect for persons
News headline on smart phone screen
[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.
.

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.
.

“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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