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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(US) A new NIH rule won’t be enough to make clinical research more inclusive – STAT (Louise Aronson | January 2019)0

Posted by Admin in on February 22, 2019
 

A quiet but revolutionary new national health policy goes into effect this week, ushering in changes that could lead to important medical discoveries that benefit most Americans. There’s just one problem. Implementing the change will require that our country’s health researchers make some fundamental changes in how they do business.

The exclusions of some sections of society from clinical trials is not merely a matter of justice (fair access to research opportunities) it can seriously limit the usefulness of the research and conceal problems with the treatment. As populations in the global north are getting older this limitation becomes more significant.  This STAT piece reflects on why the regulatory move by the NIH won’t help.

Under the National Institutes of Health’s new Inclusion Across the Lifespan policy, federally supported medical research must include patients of all relevant ages or explain their exclusion. Since most studies already include adults, and a mandate to include children has existed since 1998, the novelty in this policy is the stipulation that clinical research include people age 65 and older.
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That’s a big group. It currently includes both Donald Trump and Nancy Pelosi, Ruth Bader Ginsberg and Clarence Thomas, as well as the 50 million other older Americans, along with the rest of us who get lucky enough down the road to make it into elderhood.
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Read the rest of this discussion piece

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.\

Read the rest of this discussion piece

CRISPR-baby scientist fired by university – Nature (David Cyranoski | January 2019)0

Posted by Admin in on February 11, 2019
 

Investigation by Chinese authorities finds He Jiankui broke national regulations in his controversial work on gene-edited babies

The scientist who announced last year that he had produced the world’s first gene-edited babies has been fired by his university.

The decision, announced on 21 January by the Southern University of Science and Technology in Shenzhen, in China’s Guandong province, follows an investigation into He Jiankui’s work by provincial health authorities.

A probe by the Guangdong health ministry found that He broke national regulations against using gene-editing for reproductive purposes, Chinese state media agency Xinhua reported on 21 January.

Read the rest of this discussion piece

(UK) Crackdown on unreported trials is good news for researchers – *Research (Till Bruckner | November 2018)0

Posted by Admin in on January 27, 2019
 

With MPs, funders and regulators on the case, universities’ poor record on transparency is going to have to change, says Till Bruckner.

On 30 October, the House of Commons Science and Technology Committee issued its long-expected report on clinical trials transparency. The report notes that even today, around half of all clinical trials in the UK still fail to post their results onto registries.

As official documents go, the report is remarkably candid—the word “disappointed” leaps off the pages again and again. The parliamentarians’ ire may have been heightened by the fact that five years earlier, a similar report from the same committee called for decisive government action, evidently to little effect.

The latest report singles out universities and NHS trusts for particular criticism, citing data from the recently launched EU Clinical Trials Tracker, an online transparency tool. The tracker paints an unflattering picture of academic institutions’ performance. Across Europe, only 11 per cent of university-sponsored trials have posted their results. In contrast, many pharmaceutical companies boast reporting rates of close to 100 per cent.

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