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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(US) Safeguards for human studies can’t cope with big data – Nature (Nathaniel Raymond | April 2019)0

Posted by Admin in on April 19, 2019
 

Forty years on from a foundational report on how to protect people participating in research, cracks are showing, warns Nathaniel Raymond.

One of the primary documents aiming to protect human research participants was published in the US Federal Register 40 years ago this week. The Belmont Report was commissioned by Congress in the wake of the notorious Tuskegee syphilis study, in which researchers withheld treatment from African American men for years and observed how the disease caused blindness, heart disease, dementia and, in some cases, death.

This item obviously relates very specifically to the origins of the US human research ethics arrangements and the operation of IRBs, but the questions it poses are salient to Australasia.  The oft repeated statement: “But the information is already published and so is in the public domain and so is exempt”.  Is no longer helpful. We have provided a list of related items.

The Belmont Report lays out core principles now generally required for human research to be considered ethical. Although technically governing only US federally supported research, its influence reverberates across academia and industry globally. Before academics with US government funding can begin research involving humans, their institutional review boards (IRBs) must determine that the studies comply with regulation largely derived from a document that was written more than a decade before the World Wide Web and nearly a quarter of a century before Facebook.
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It is past time for a Belmont 2.0. We should not be asking those tasked with protecting human participants to single-handedly identify and contend with the implications of the digital revolution. Technological progress, including machine learning, data analytics and artificial intelligence, has altered the potential risks of research in ways that the authors of the first Belmont report could not have predicted. For example, Muslim cab drivers can be identified from patterns indicating that they stop to pray; the Ugandan government can try to identify gay men from their social-media habits; and researchers can monitor and influence individuals’ behaviour online without enrolling them in a study.
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(Australia Queensland case) Universal Medicine research conducted by devotees won’t be pulled by Queensland uni – ABC (Josh Robertson | March 2019)0

Posted by Admin in on March 25, 2019
 

A top Australian university has stood by studies into the health benefits of a group that a jury found was a “dangerous cult” making false healing claims, despite its own medical researchers failing to disclose they were devotees.

The investigation finding, as reported by the ABC, isn’t the most bewildering/troubling element of this case – but it’s pretty close.

A 10-month investigation by the University of Queensland (UQ) has cleared the researchers of academic misconduct despite finding they did not fully detail their involvement with Universal Medicine (UM).
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The studies were published in overseas journals and explored the benefits of UM treatments including “esoteric breast massage” and proposed clinical studies in Vietnamese hospitals that would be forbidden in Australia.
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The Foundation of Knowledge Production: Research Ethics Education in Taiwan (PowerPoint: Chien Chou | September 2018)0

Posted by Admin in on March 24, 2019
 

Outline

1. The Importance of Research Ethics
2. Researchers’Needs for Education
3. Education and Implementation Mechanism of Research Ethics in Taiwan’s Higher Education
4. Concluding Remarks

The Importance of research ethics

• Presents a baseline for all research behaviors
• Protects others, minimizes harm and increases the sum of good
• Supports trust among researchers and between research communities and the public
• Ensures research integrity and quality
• Satisfies organizational and professional demands • Copes with new and more challenging problems

Access Chien Chou’s presentation

China to tighten rules on gene editing in humans – Nature (David Cyranoski | March 2019)0

Posted by Admin in on March 21, 2019
 

In the wake of the gene-edited-baby scandal, scientists and institutions could face tough penalties for breaking the rules.

China’s health ministry has issued draft regulations that will restrict the use of gene editing in humans, just three months after Chinese researcher He Jiankui announced that twin girls had been born with edited genomes. The proposal includes severe penalties for those who break the rules. If approved, scientists say the policy could have gains and drawbacks for research.

The draft regulations, issued by the National Health Commission on 26 February, state that gene editing in any type of cell that will end up in humans, including embryos, will need the commission’s approval, as will other high-risk biomedical procedures.

The regulations come in response to He’s claim, in late November, that he used the gene-editing technology CRISPR–Cas9 to alter the genomes of embryos — a process known as germline editing — to make them resistant to HIV. He then implanted the edited embryos into women. News that twin girls had been born as a result of these experiments prompted an international outcry about He’s use of a risky and unproven technology.

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