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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Not Reporting Results of a Clinical Trial Is Academic Misconduct – ACP (Editorial | Joshua D. Wallach, MS, PhD; Harlan M. Krumholz, MD, SM | May 2019)0

Posted by Admin in on July 3, 2019
 

Failure to report the results of clinical trials threatens the public’s trust in research and the integrity of the medical literature, and should be considered academic misconduct at the individual and institutional levels. According to the ethical principles for research outlined in the Declaration of Helsinki, researchers “have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports” (1). When participants volunteer to take part in clinical trials, and expose themselves to interventions with unknown safety and efficacy profiles, they have a tacit assumption, based on trust, that the evidence generated will inform clinical science (2). Health care providers and medical societies, who are responsible for evaluating and synthesizing evidence and filling the gap between research and practice, need for investigators to fully report their results in a timely manner. The utility of the diligent search for truth in the medical literature depends on its completeness. However, when research findings are not consistently disseminated, the literature provides a skewed view of the science, which may bias reviews of the evidence.

During the past 2 decades, efforts have been increasing to promote the reporting of clinical trial results. After the creation of ClinicalTrials.gov, a public registration database, the United States moved to establish consequences of not reporting clinical trial results. In particular, the U.S. Food and Drug Administration Amendments Act (FDAAA) of 2007 created legal requirements for certain intervention studies of FDA-regulated…

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Fake news about the past is a crime against history – University World News (Antoon De Baets | May 2019)0

Posted by Admin in on June 29, 2019
 

Historians observing the current debate on fake news are tempted to make comments from a long-term perspective. First, fake news, as a type of lie that constitutes disinformation, has an ancient pedigree.

Indeed, among the plethora of primary sources used by historians to study the past, some are forged, many distorted and all are biased. To filter truth from such sources, historians have developed a severe method of source criticism over the ages, first in East Asia and Europe.

Although an old phenomenon, fake news in its recent guises also has some strikingly new features because it spreads on the internet nowadays, mainly via social media platforms.

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Guidelines for open peer review implementation (Paper: Tony Ross-Hellauer and Edit Görögh | February 2019)0

Posted by Admin in on June 28, 2019
 

Abstract
Open peer review (OPR) is moving into the mainstream, but it is often poorly understood and surveys of researcher attitudes show important barriers to implementation. As more journals move to implement and experiment with the myriad of innovations covered by this term, there is a clear need for best practice guidelines to guide implementation. This brief article aims to address this knowledge gap, reporting work based on an interactive stakeholder workshop to create best-practice guidelines for editors and journals who wish to transition to OPR. Although the advice is aimed mainly at editors and publishers of scientific journals, since this is the area in which OPR is at its most mature, many of the principles may also be applicable for the implementation of OPR in other areas (e.g., books, conference submissions).

Keywords
Peer review, Guidelines, Open peer review, Scholarly publishing, Open science

Ross-Hellauer, T. and Görögh, E. (2019) Guidelines for open peer review implementation. Research Integrity and Peer Review. 4(4)
https://doi.org/10.1186/s41073-019-0063-9
Publisher (Open Access): https://researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-019-0063-9

(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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