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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Whose hearts, livers and lungs are transplanted in China? Origins must be clear in human organ research – The Conversation (Wendy Rogers and Matthew Robertson | February 2019)0

Posted by Admin in on February 14, 2019
 

Scientist He Jiankui’s claimed use of the genetic tool CRISPR to edit the genomes of twin girls led to international condemnation. His actions have focused a spotlight on research ethics – and what the consequences should be when scientists “go rogue”.

The Chinese Academy of Science initially looked into He’s conduct, and a subsequent internal government investigation has allegedly identified multiple violations of state laws. He has now been fired by his university.


Read more: Tension as scientist at centre of CRISPR outrage speaks at genome editing summit


But beyond just this example, what does happen when scientists fail to comply with globally-accepted guidelines for ethical medical research? We examined this issue focusing on published research involving recipients of organ transplants performed in the People’s Republic of China.\

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Wake-up call from Hong Kong – Science (Victor J. Dzau, et al | December 2018)0

Posted by Admin in on February 12, 2019
 

The Second International Summit on Human Genome Editing, held in Hong Kong last month, was rocked by the revelation from a researcher from Shenzhen that twins were born whose healthy embryonic genomes had been edited to confer resistance to HIV. Despite widespread condemnation by the summit organizing committee, world scientific academies, and prominent scientific leaders that such research was “deeply disturbing” and “irresponsible,” and the launch of an investigation in China into the researcher’s actions, it is apparent that the ability to use CRISPR-Cas9 to edit the human genome has outpaced nascent efforts by the scientific and medical communities to confront the complex ethical and governance issues that they raise. The current guidelines and principles on human germline genome editing are based on sound scientific and ethical principles. However, this case highlights the urgent need to accelerate efforts to reach international agreement upon more specific criteria and standards that have to be met before human germline editing would be deemed permissible.

“We need…broad agreement on…criteria for human germline genome editing research…”

Together, we call upon international academies to quickly convene international experts and stakeholders to produce an expedited report that will inform the development of these criteria and standards to which all genome editing in human embryos for reproductive purposes must conform, and to engage scientific bodies around the world in this effort. The United States National Academies are willing to lead in this endeavor. Academies are well-positioned to convene needed international expertise and to help foster broad scientific consensus on the responsible pursuit of human genome editing research and clinical applications. We strongly believe that international consensus on such standards is important to avoid the potential for researchers to rationalize the justification or seek out convenient locales for conducting dangerous and unethical experimentation. The establishment of international scientific standards is not intended to substitute for national regulation but could inform such regulation.

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American scientist played more active role in ‘CRISPR babies’ project than previously known – STAT (Jane Qiu | January 2019)0

Posted by Admin in on February 11, 2019
 

BEIJING — An American scientist at Rice University was far more involved in the widely condemned “CRISPR babies” experiment than has previously been disclosed. Most notably, STAT has learned that Rice biophysicist Michael Deem was named as the senior author on a paper about the work that was submitted to Nature in late November.

Deem’s prominent authorship indicates that a respected American researcher played an instrumental role in the controversial project, which sparked a worldwide furor. His involvement could have encouraged volunteers to join the experiment and lent credibility to He Jiankui, the Chinese scientist who led the work.

Emails provided to STAT show that Deem was listed as the last author — which, in the life sciences, is typically reserved for the senior researcher who oversees a study. The paper, titled “Birth of twins after genome editing for HIV resistance,” has another nine contributors, including He as the first author, where the person who makes the most hands-on contribution is credited.

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Doctor who participated in fake chocolate study fined for violating code of conduct – Retraction Watch (Hinnerk Feldwisch-Drentrup | September 2016)0

Posted by Admin in on January 30, 2019
 

A German district attorney has fined a doctor who participated in a bogus study showing chocolate helps weight loss, designed to illustrate how shady science can make the news, arguing it was unethical to ask people to participate unknowingly in such a scam.

This item generated considerable discussion on the Retraction Watch website, including the doctor disputing some of the observations.

As soon as the study was published, critics raised questions over whether it was appropriate to include volunteers in a bogus clinical trial, which included giving blood. Recently, a German district attorney for professional conduct of physicians ruled that it was not.
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In an anonymized version of a decision from the district attorney – who investigates on possible violations of the physicians’ professional law – he fined the doctor who participated in a bogus study about the health benefits of chocolate 500 Euros for not obtaining proper consent from the people who volunteered to participate, and for not involving an ethics committee.
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