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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.\

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.

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(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.

Including People with Dementia in Research: An Analysis of Australian Ethical and Legal Rules and Recommendations for Reform (Papers: Nola M. Ries, et al | 2017)0

Posted by Admin in on January 24, 2019
 

Abstract
Research is crucial to advancing knowledge about dementia, yet the burden of the disease currently outpaces research activity. Research often excludes people with dementia and other cognitive impairments because researchers and ethics committees are concerned about issues related to capacity, consent, and substitute decision-making. In Australia, participation in research by people with cognitive impairment is governed by a national ethics statement and a patchwork of state and territorial laws that have widely varying rules. We contend that this legislative variation precludes a consistent approach to research governance and participation and hinders research that seeks to include people with impaired capacity. In this paper, we present key ethical principles, provide a comprehensive review of applicable legal rules in Australian states and territories, and highlight significant differences and ambiguities. Our analysis includes recommendations for reform to improve clarity and consistency in the law and reduce barriers that may exclude persons with dementia from participating in ethically approved research. Our recommendations seek to advance the national decisionmaking principles recommended by the Australian Law Reform Commission, which emphasize the rights of all adults to make their own decisions and for those with impaired capacity to have access to appropriate supports to help them make decisions that affect their lives.

Keywords
Research ethics, Law. Dementia, Consent, Substitute decision-making, Advance directives

Ries, N. M., Thompson KA., & Lowe M. (2017) Including People with Dementia in Research: An Analysis of Australian Ethical and Legal Rules and Recommendations for Reform. Journal of Bioethical Inquiry 14(3): 359-374.
https://link.springer.com/article/10.1007%2Fs11673-017-9794-9