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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Friday afternoon’s funny – Investigating research misconduct0

Posted by Admin in on May 15, 2020
 

Cartoon by Don Mayne www.researchcartoons.com
Full-size image for printing (right mouse click and save file)

Even though we’re fans of Sherlock, solving research misconduct cases rarely require the renowned detective’s skill and the findings are rarely celebrated.  But they should be publicly reported.

How Universities Cover Up Scientific Fraud – Areo (Justin T Pickett | February 2020)0

Posted by Admin in on March 1, 2020
 

I learned a hard lesson last year, after blowing the whistle on my coauthor, mentor and friend: not all universities can be trusted to investigate accusations of fraud, or even to follow their own misconduct policies. Then I found out how widespread the problem is: experts have been sounding the alarm for over thirty years.

Whistleblower points to a pattern of faux investigations into research misconduct aimed at protecting the host institution.

One in fifty scientists fakes research by fabricating or falsifying data. They make off with government grant money, which they share with their universities, and their made-up findings guide medical practice, public policy and ordinary people’s decisions about things like whether or not to vaccinate their children. The fraudulent science we know about has caused thousands of deaths and wasted millions in taxpayer dollars. That is only scratching the surface, however—because most fraudsters are never caught. As Ivan Oransky notes in Gaming the Metrics, “the most common outcome for those who commit fraud is: a long career.”
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There are two reasons for this. First, many scientists who witness fraud don’t report it, because they believe nothing would happen if they did and they fear retaliation. Second, when fraud is reported, the job of investigating it falls to the fraudsters’ universities. Most whistleblowers inform their universities directly. Even if they don’t, federal agencies, like the National Science Foundation and the National Institutes of Health, refer fraud accusations back to universities for investigation, and publishers and the Committee on Publication Ethics tell journal editors to do the same.
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(US) Rounding up the Belmont Report Retrospectives – Amp@sand (May 2019)0

Posted by Admin in on June 27, 2019
 

Last month brought the 40th anniversary of the publishing of the Belmont Report, and along with that milestone came a reflection on how its values, conclusions, and imperatives have changed in the intervening years. A celebration of its durability has been accompanied by a necessary reckoning with the ways that a 40-year-old document may be ill-equipped to process the ethical issues brought about by technological, cultural, and political changes. Here, we’ve gathered a range of resources that look back on 40 years of the Belmont Report.

Safeguards for human studies can’t cope with big data
Nature
This provocative piece explores the ways in which the Belmont Report is insufficient for dealing with revolutionary digital technologies, arguing that “data science overlooks risks to human participants by default” and that it is “past time for a Belmont 2.0.” That new summit, the author argues, would need to engage with the currently “poorly understood risks and harms” that big data researches poses to humans.

A Belmont Report for Health Data (abstract available)
The New England Journal of Medicine
HIPAA offers robust protection of a limited range of data, but in 2019, the demands on humans’ health data come from far more directions than the 1996 legislation could anticipate. The authors of this NEJM piece call for a coordinated expansion of the scope of ethical review of the gathering, use, and manipulation of health data to account for sources such as “social-media platforms, health and wellness apps, smartphones [and] life insurers,” citing concerns about reidentification of deidentified data, discrimination, health profiling, and more.

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The Next Phase of Human Gene-Therapy Oversight – The New England Journal of Medicine (Francis S. Collins and Scott Gottlieb | August 2018)0

Posted by Admin in on October 18, 2018
 

The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) have played key roles in the emergence of safe and effective human gene therapies. Now, we are proposing new efforts to encourage further advances in this rapidly evolving field.

The potential to alter human genes directly was first recognized nearly 50 years ago, around the same time as initial groundbreaking advances were being made in recombinant DNA technology. After intense discussions regarding the ethical, legal, and social implications of this technology, conversations were initiated at the NIH that led to the establishment of the Recombinant DNA Advisory Committee (RAC) in 1974. The RAC’s mission was to advise the NIH director on research that used emerging technologies involving manipulation of nucleic acids — a mission that was eventually expanded to encompass the review and discussion of protocols for gene therapy in humans. In 1990, the FDA oversaw the first U.S. human gene-therapy trial, which involved pediatric patients with adenosine deaminase deficiency and was conducted at the NIH Clinical Center in Bethesda, Maryland.

Although no major safety concerns were initially reported, over the course of the 1990s it became evident that many questions regarding the safety and efficacy of gene therapy remained unanswered. These unknowns were brought into sharp focus in 1999 when Jesse Gelsinger died of a massive immune response during a safety trial of gene therapy for ornithine transcarbamylase deficiency.1 This tragic death led to closer scrutiny of the field, including a greater focus on open dialogue and increased regulatory oversight.

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