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Pragmatic trials without informed consent? – The Ethics Blog (Pär Segerdahl | April 2019)0

Posted by Admin in on July 9, 2019

Randomized controlled trials (RCTs) are considered to be the gold standard for determining a causal effect of medical interventions. To achieve this aim, possible confounding factors must be avoided. This implies excluding many patients from participating in the trial, for example, patients with concomitant conditions. A negative consequence of these exclusions, however, is limited generalizability. Studying the artificially uniform participant group, you will be able to determine a causal effect, but you will know much less about real-life treatment outcomes in the population where the intervention actually will be used.

This radical and controversial idea isn’t currently permissible in many jurisdictions (including Australia), but that doesn’t mean it isn’t worth serious discussion.

Further artificiality is created by the written informed consent procedure, which excludes even further patients from participating in the trial. Moreover, because they know they participate in a clinical trial, participants may change their behavior.

All this points to the importance of so-called pragmatic randomized controlled trials. In such trials, the effectiveness of two approved and routinely prescribed medicines are compared in normal clinical practice. This avoids most of the artificiality of RCTs and significantly improves generalizability and practical clinical relevance. Randomization is still required for scientific purposes, however, and written informed consent is an ethical obligation.

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(Japan) Researcher at Japan stem cell institute falsified nearly all images in 2017 paper – Retraction Watch (Victoria Stern | January 2019)0

Posted by Admin in on May 25, 2019

An investigation by Kyoto University in Japan has found a researcher guilty of falsifying all but one of the figures in a 2017 stem cell paper.

Yesterday, Kyoto University announced that the paper’s first author, Kohei Yamamizu, had fabricated and falsified data in the Stem Cell Reports paper. According to the investigation report, none of the other authors were involved in the data manipulation.

Yamamizu works at the Center for iPS cell Research and Application (CiRA) at Kyoto University, directed by Shinya Yamanaka, a Nobel Prize winner for his pioneering work in stem cell biology.

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Aboriginal genome analysis comes to grips with ethics – Nature (Ewen Callaway | September 2011)0

Posted by Admin in on May 12, 2019

Sequencing effort provides a model for future studies of museum samples.

En route from Sydney to Perth, Australia, in the early 1920s, British ethnologist Alfred Cort Haddon acquired a tuft of human hair from a young Aboriginal man. He added it to his sizeable collection of hair from people living around the world.

Ninety years later, those locks have yielded the first complete genome sequence of an Aboriginal Australian, and provided clues about the timing of human migrations from Africa to Asia1 (see ‘Early human explorers charted a bold course’). The work has also underscored the bioethical dilemmas involved in plumbing the genomes of indigenous populations — especially when the DNA comes from an archived specimen such as Haddon’s. “To be sequencing DNA from the hair of a deceased indigenous person is uncharted ethical territory,” says Emma Kowal, a cultural anthropologist at the University of Melbourne.

The genome project, led by Eske Willerslev at the University of Copenhagen, received approval for the work from a group that represents Aboriginals in the region in which the man probably lived. But some scientists are jittery about how others in the Aboriginal community might receive the project, and worry that it could set back efforts to engage Aboriginals in genetic research. “In a sense, every Aboriginal Australian has had something about themselves revealed to the world without their consent,” says Hank Greely, who directs the Center for Law and the Biosciences at Stanford University in California.

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Indigenous groups look to ancient DNA to bring their ancestors home – Nature (Nicky Phillips – April 2019)0

Posted by Admin in on May 9, 2019

Local communities and geneticists are working together to sequence DNA from remains that were taken from their homelands decades ago.

Several years ago, Gudju Gudju Fourmile welcomed back several members of his Yidinji community who had been taken from their homes in northern Australia almost a century ago. Like many other Indigenous communities in Australia, the Yidinji have worked for decades to bring the bodies of their ancestors home — which Aboriginal communities describe as returning to Country.

Many of the ancestors are off Country as a result of the dehumanizing practices of the nineteenth and early twentieth centuries, when it was common for white collectors to loot graves and sell the remains of Aboriginal people to museums in Australia, the United Kingdom and other countries. “When our remains are off Country, we try to make sure they come back,” says Fourmile, an elder in the community who lives in Cairns. “They need to be comfortable. That’s a big thing for many tribal groups.” And when his community finally reburied its ancestors in 2014, “everybody was so happy. And the Country felt good again,” Fourmile says.

Before the Yidinji elders laid their ancestors to rest, they received a request from scientists who had been analysing the DNA of living community members: could they sequence the ancestors’ genomes, too? With permission granted, a team led by evolutionary geneticist David Lambert at Griffith University in Brisbane extracted DNA from the remains of one individual, and confirmed that the ancient person was closely related to Yidinji people alive today1,2. “When you find something out like that, you jump for joy,” says Fourmile. The event also marked a turning point in the mindset of the community, he says, when members started to realize the potential of DNA analysis to help bring their people back home.

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