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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

‘Science by tweet’ prompts expression of concern, irking authors – Retraction Watch (Adam Marcus | October 2019)0

Posted by Admin in on November 29, 2019
 

The leader of an international team of genetics researchers is seething after a journal responded to critical tweets about their paper by issuing an expression of concern.

Really useful debate about who should be the arbiter of scientific debate. Can science be called out through public fora?

The article, “Exome sequencing in multiple sclerosis families identifies 12 candidate genes and nominates biological pathways for the genesis of disease,” was published in PLOS Genetics in early June 2019 by a group led by Carles Vilariño-Güell, of the Department of Medical Genetics at the University of British Columbia in Vancouver.
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Less than a week after publication, according to Vilariño-Güell, the journal notified him that:

There are 93 tweets in the conversation about the paper started by Daniel MacArthur. It is overwhelmingly negative towards the journal and paper. In addition to MacArthur (32.9k followers) weighing in, other names and influencers including Jeffrey Ross-Ibarrra (UC Davis, 6.2k followers), Heidi Rehm (Mass General, 4.4k followers), Manuel Rivas (Stanford, 2.2k followers), etc. One positive tweet appears responding to PLOS Genetics’ own coverage of this paper.

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Breakthrough Gene Therapy Clinical Trial is the World’s First That Aims to Reverse 20 Years of Aging in Humans – CISION (Osvaldo R. Martinez-Clark | November 2019)0

Posted by Admin in on November 28, 2019
 

This is the world’s first IRB-approved clinical trial aimed at reversing aging by at least 20 years; it is also the world’s most expensive pay-to-play trial with a one million price tag to enroll.

This isn’t a human research ethics vignette/scenario, but could very easily be used as the basis for a discussion with researchers, research ethics reviewers, research ethics advisers, or research office staff about:
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  1. Pay-to-play clinical trials
  2. Appropriate recruitment materials
  3. The use of ethics approval as a sales tool
  4. The conduct of trials in another country

MANHATTAN, Kan., Nov. 21, 2019 /PRNewswire/ — Libella Gene Therapeutics, LLC (“Libella”) announces an institutional review board (IRB)-approved pay-to-play clinical trial in Colombia (South America) using gene therapy that aims to treat and ultimately cure aging. This could lead to Libella offering the world’s only treatment to cure and reverse aging by 20 years.
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Under Libella’s pay-to-play model, trial participants will be enrolled in their country of origin after paying $1 million. Participants will travel to Colombia to sign their informed consent and to receive the Libella gene therapy under a strictly controlled hospital environment.
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Traditionally, aging has been viewed as a natural process. This view has shifted, and now scientists believe that aging should be seen as a disease. The research in this field has led to the belief that the kingpin of aging in humans is the shortening of our telomeres.
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Telomeres are the body’s biological clock. Every time a cell divides, telomeres shorten, and our cells become less efficient at dividing again. This is why we age. A significant number of scientific peer-reviewed studies have confirmed this. Some of these studies have shown actual age reversal in every way imaginable simply by lengthening telomeres.
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Examination of CIs in health and medical journals from 1976 to 2019: an observational study (Papers: Adrian Gerard Barnett, Jonathan D Wren | November 2019)0

Posted by Admin in on November 26, 2019
 

Abstract

Objectives
Previous research has shown clear biases in the distribution of published p values, with an excess below the 0.05 threshold due to a combination of p-hacking and publication bias. We aimed to examine the bias for statistical significance using published confidence intervals.

Design Observational study.

Setting
Papers published in Medline since 1976.

Participants
Over 968 000 confidence intervals extracted from abstracts and over 350 000 intervals extracted from the full-text.

Outcome measures
Cumulative distributions of lower and upper confidence interval limits for ratio estimates.

Results
We found an excess of statistically significant results with a glut of lower intervals just above one and upper intervals just below 1. These excesses have not improved in recent years. The excesses did not appear in a set of over 100 000 confidence intervals that were not subject to p-hacking or publication bias.

Conclusions
The huge excesses of published confidence intervals that are just below the statistically significant threshold are not statistically plausible. Large improvements in research practice are needed to provide more results that better reflect the truth.

Barnett, A.G., Wren, J.D. (2019)  Examination of CIs in health and medical journals from 1976 to 2019: an observational study. 

Wildlife Cameras Are Accidentally Capturing Humans Behaving Badly – Nature (James Dinneen | November 2019)0

Posted by Admin in on November 25, 2019
 

Scientists face an ethical dilemma over what to do with their ‘human bycatch’

To study wildlife, Dr. Nyeema Harris, an assistant professor in the Ecology and Evolutionary Biology Department at the University of Michigan, uses camera traps — remotely triggered cameras that take pictures when they detect movement and body heat. Harris, a wildlife biologist, is not typically interested in humans, but sometimes they still end up in her photographs.

This is another example of researchers who may not be accustomed to thinking about human research ethics matters (in this case wildlife research and accidentally capturing images of people) and the question of how to inform their practice. This is really useful and important discussion. The issues in play are no different to government and others using CCTV, which they do without consent. We have created a somewhat artificial divide between research and real life. Any useful research reflects and interacts with real life. In this case, the capture is identifying some bad behaviour which is useful to know about and to act upon. The social good outweighs privacy rights. We should all be discussing this more.

Between 2016 and 2018, Harris led the first published camera trap survey ever conducted in Burkina Faso and Niger, originally conceived to focus on the critically endangered West African lion. But Harris ended up capturing so much human activity that she expanded the focus of her study to include how humans were using the area. Research on human activity in the wildlife preserve had typically relied on humans reporting their own actions, but with the cameras, Harris could see what they were actually doing. “The data emerged to be a really interesting story that I felt compelled to tell,” Harris says.
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Even in studies conducted in remote nature reserves, meant to capture wildlife at its wildest, people showed up.
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When camera traps inadvertently capture human activity, it’s called “human bycatch.” And according to a 2018 University of Cambridge study, Harris is far from the only researcher to have ended up with humans in the data. The study included a survey of 235 scientists across 65 countries about their experiences with human bycatch, and 90% of them reported capturing some images of people in their most recent projects. Even in studies conducted in remote nature reserves, meant to capture wildlife at its wildest, people showed up.
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As in Harris’s study, this human data doesn’t always stay “bycatch.” Nearly half of respondents to the Cambridge survey said they had used images of people apparently involved in illegal activity to inform wildlife management efforts. Many of them had reported images to law enforcement, others to conservation staff, and some to the media. All this, despite only 8% of projects having set out to capture images of people.
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