ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Resource Library

Research Ethics MonthlyAbout Us

ResourcesMedical research

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

German ethics council expresses openness to eventual embryo editing – STAT (Sharon Begley | May 2019)0

Posted by Admin in on May 30, 2019
 

panel of government-appointed experts in Germany agreed unanimously that the human germline — DNA that is inherited by children from their parents — “is not inviolable,” rejecting one objection to using genome editing technologies such as CRISPR to make heritable changes in the DNA of human embryos, sperm, or eggs.

The detail of this decision doesn’t open the door for DNA editing of embryos/eggs/sperm in Germany now, it is, however, a movement in that direction.

In a 47-page report made public on Monday, the independent German Ethics Council concluded that the power of CRISPR, and the announcement last November that a scientist in China had used it to edit two IVF embryos that resulted in the birth of twin girls, means that “the possibility of intervening more easily and precisely in the human germline is drawing closer and closer.”
.

Although the council’s 26 ethicists, legal scholars, scientists, and other experts agreed unanimously that there are no compelling philosophical arguments against altering human germlines, they also concluded that it is ethically irresponsible to do so now.
.

Read the rest of this news story

China tightens its regulation of some human gene editing, labeling it ‘high-risk’ – Science (Dennis Normile | February 2019)0

Posted by Admin in on May 19, 2019
 

In the wake of the shocking news that one of its scientists had produced genetically altered babies, the Chinese government this week issued draft regulations that would require national approval for clinical research involving gene editing and other “high-risk biomedical technologies.” Although some Chinese researchers welcome the move to tighten oversight, there are worries that the rules could impose a burden on areas of genetic research that are not so controversial.

“I am happy to see the national regulations regarding new biomedical technologies; I think this makes relevant policy more clear,” says Wei Jia, a medical oncologist who is involved with an ongoing trial using gene editing to modify cancer patient T-cells at the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School in China.

The regulations are in response to the late November 2018 claim by He Jiankui, then of Southern University of Science and Technology in Shenzhen, China, that he had altered the DNA embryos in a way that would give the babies and their descendants resistance to HIV. This approach is called germline engineering—it can involve changing DNA in embryos or sperm or eggs—and is banned in many countries, by law or regulation. He’s effort, using a technique called CRISPR, resulted in twin girls born last fall; one more baby, he said, is on the way. The experiment earned He worldwide condemnation for prematurely using a still glitchy technique that might negatively affect the babies’ development and health in a medically unnecessary and unjustified intervention.

Read the rest of this discussion piece

Chinese government funding may have been used for ‘CRISPR babies’ project, documents suggest – STAT (Jane Qiu | February 2019)0

Posted by Admin in on May 19, 2019
 

BEIJING — Three government institutions in China, including the nation’s science ministry, may have funded the “CRISPR babies” study that led to the birth last November of two genetically modified twin girls, according to documents reviewed by STAT.

These findings appear to support what many researchers inside and outside China have suspected since scientist He Jiankui revealed the births in late November, sparking international condemnation for violating scientific guidelines against the use of gene-edited human embryos to start pregnancies. “I don’t think He Jiankui could have done it without the government encouragement to press ahead” with research they thought would merit a Nobel Prize, said Jing-Bao Nie, a bioethicist at the University of Otago in New Zealand.

If the documents are correct, they would suggest China is supporting research that the U.S. and other countries consider unethical, and raise doubts about the preliminary conclusion of a government investigation that He acted mostly on his own. That inquiry, which was led by the Guangdong provincial health commission and involved the science ministry and the National Health Commission, determined that He raised funding for the experiment on his own without official endorsement. It also concluded that He forged an informed-consent form and violated scientific ethics and Chinese regulations, according to the official Xinhua News Agency.

Read the rest of this news story

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.
.
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.
.

Read the rest of this discussion piece

0