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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Move clinical trial data sharing from an option to an imperative – STAT (Rebecca Li | February 2019)0

Posted by Admin in on February 28, 2019
 

Data from clinical trials have long been locked away, some in this principal investigator’s computer bank, some in that pharmaceutical company’s cloud. For years we have been talking about opening up those vaults and freeing these data. The key has finally turned: Data sharing is becoming the new reality.

From Jan. 1, 2019, onward, the world’s leading medical journals, including the New England Journal of Medicine, the Lancet, Annals of Internal Medicine, BMJ, and thousands more require authors to disclose whether and how they plan to share deidentified raw data from individual participants in their clinical trials. What’s more, researchers wishing to publish in these journals must declare their data-sharing plans in a public registry, such as ClinicalTrials.gov.

It’s a radical departure from where we’ve been. In my former life conducting trials as a scientist in industry and for the National Institutes of Health, when I’d log onto ClinicalTrials.gov to register a new trial, I didn’t have to give a second thought to if or how I’d be sharing data from the trial. Now all researchers need to think about that from the very beginning, even before the first trial participant is enrolled.

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Research Ethics Policy Note no. 12 – Research Involving Illegal Activities0

Posted by Admin in on February 7, 2019
 

The University of Sheffield Research Ethics Policy Note no. 12
Research Involving Illegal Activities

This is a complex area. There is a long tradition of social science research into illegal activity that has enriched public debate about crime and a range of other public issues. Similarly, researchers in psychology or medicine, for example, might in the course of their research learn about criminal activity. But what is the legal and ethical position of the researcher in such circumstances?

1. LEGAL RESPONSIBILITIES
Researchers have the same legal obligations that they would have in any other context, as citizens or legal residents. As a private member of society, there is, however, no general legal obligation in the United Kingdom to report to the relevant authorities all illegal activity that one observes or learns about.

However, there may be moral obligations to report in the following circumstances:

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Single-molecule magnet controversy highlights transparency problems with U.K. research integrity system – C&EN (Mark Peplow | November 2018)0

Posted by Admin in on January 26, 2019
 

Universities’ reluctance to reveal details of such cases could undermine public trust in research, experts say

For Conrad A. P. Goodwin, June 6, 2017, was a pretty harrowing day. The organometallic chemist, then at the University of Manchester, had just finished his Ph.D. on a high. Earlier that year he had synthesized an organometallic complex called dysprosocenium that could be switched from one stable magnetic state to another. Single-molecule magnets (SMMs) like this might eventually be used in extremely-high-density memory devices, but researchers had previously been able to make SMMs that only operated at ultracold temperatures. Crucially, Goodwin’s molecule could retain its designated magnetic state at up to 60 K—the highest temperature yet for any SMM. By the end of May, Nature had accepted a paper about the work from Goodwin and his colleagues, subject to revisions.

Then, on that fateful June day—months before Goodwin’s report actually published—a paper appeared in Angewandte Chemie describing exactly the same molecule, made in exactly the same way. Goodwin and his colleagues had been scooped. To make matters worse, the team behind the Angewandte paper was led by Richard A. Layfield, a professor whose office was just down the hall from Goodwin’s supervisor, David P. Mills.

“We’d put so much work into it,” recalls Goodwin, who now works at Los Alamos National Laboratory. “The synthetic methodology was brand new, so we thought we were on to something cool. Then, suddenly, the novelty was gone.”

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From Paywall to Datawall – Scholarly Kitchen (Lisa Janicke Hinchliffe | October 2018)0

Posted by Admin in on January 3, 2019
 

Almost every day, my email or Twitter feed brings an alert to a “free” report, article, white paper, etc. No payment or subscription required!

This isn’t a ‘core’ research integrity piece but we thought the privacy and research outputs issues are significant enough to warrant inclusion in the Resource Library

It sounds great. In many ways it is the promise of the Internet fulfilled, a world in which a single click brings you the document you are seeking for immediate review or even a deep read.
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The reader experience, however, is quite often not exactly that. Instead of a paywall, perhaps to be negotiated through a proxy server or some other authentication mechanism, the reader is faced with a demand for their contact information. Or, even more demanding, they face a requirement to create an account. Use of that account will be tracked and the data fed into an analytics system, likely joined up with data collected elsewhere as well.
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