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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(US) Safeguards for human studies can’t cope with big data – Nature (Nathaniel Raymond | April 2019)0

Posted by Admin in on April 19, 2019
 

Forty years on from a foundational report on how to protect people participating in research, cracks are showing, warns Nathaniel Raymond.

One of the primary documents aiming to protect human research participants was published in the US Federal Register 40 years ago this week. The Belmont Report was commissioned by Congress in the wake of the notorious Tuskegee syphilis study, in which researchers withheld treatment from African American men for years and observed how the disease caused blindness, heart disease, dementia and, in some cases, death.

This item obviously relates very specifically to the origins of the US human research ethics arrangements and the operation of IRBs, but the questions it poses are salient to Australasia.  The oft repeated statement: “But the information is already published and so is in the public domain and so is exempt”.  Is no longer helpful. We have provided a list of related items.

The Belmont Report lays out core principles now generally required for human research to be considered ethical. Although technically governing only US federally supported research, its influence reverberates across academia and industry globally. Before academics with US government funding can begin research involving humans, their institutional review boards (IRBs) must determine that the studies comply with regulation largely derived from a document that was written more than a decade before the World Wide Web and nearly a quarter of a century before Facebook.
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It is past time for a Belmont 2.0. We should not be asking those tasked with protecting human participants to single-handedly identify and contend with the implications of the digital revolution. Technological progress, including machine learning, data analytics and artificial intelligence, has altered the potential risks of research in ways that the authors of the first Belmont report could not have predicted. For example, Muslim cab drivers can be identified from patterns indicating that they stop to pray; the Ugandan government can try to identify gay men from their social-media habits; and researchers can monitor and influence individuals’ behaviour online without enrolling them in a study.
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We need to relearn how to play nice in peer review – UA/AU (Daniel Harris | March 2019)0

Posted by Admin in on April 16, 2019
 

By changing the way we discuss scholarly work, we will not only improve scholarship but also reduce the unnecessary hostility rampant in academia.

Academia has emerged as an unassuming minefield of mental health hazards. Examples from the scholarly and lay literatures detail rampant depression, anxiety and panic symptoms among academics, especially graduate students. A recent study of over 3,000 PhD students in Belgium revealed that 32 percent were at risk of having or developing a psychiatric disorder. It was also found that compared to a highly educated general population, PhD students had 3.5 times the risk of lost self-confidence and 3.4 times the risk of feeling worthless. Family-work conflicts and a culture of closed decision-making were among the strongest independent predictors of psychiatric distress among participants.

A recent example from the news media described “the silencing effect of academia” and the “need to be thick-skinned” to progress successfully as an academic. Despite the concerning severity and omnipresence of anxiety experienced by the author and the author’s peers, a culture of silence reigned. Nature also published a series of testimonials written by doctoral students and researchers describing their experiences with mental health and suggestions to drive culture change. Establishing support systems, broadening career prospects, and accessing professional mental health services, were among the many suggestions to remain resilient in a viciously competitive, and at times, distressingly lonely work environment. As a PhD student in epidemiology, my lay review of these articles forced me to consider my own journey as a researcher and graduate student in public health.

Like most graduate students, I suffer from imposter syndrome. As such, I obsess about the quality of my work – afraid, at best, to disappoint my department and mentor, and at worst, to have my name blacklisted among the community of public health researchers. While my obsessive tendencies are arguably adaptive, they nonetheless hinder my quality of life and have questionable long-term sustainability. Therefore, like the scientist I am, I went searching for possible etiological explanations for my worsening anxiety. Paradoxically, I discovered that I frequently contribute to the very academic culture causing my own mental health challenges: the unnecessary and unacademic belittling of peer-reviewed work.

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Duke University’s huge misconduct fine is a reminder to reward rigour – Nature (Arturo Casadevall | April 2019)0

Posted by Admin in on April 15, 2019
 

US$112.5-million settlement concerning fraudulent data is a casualty of a culture that prizes impact over robustness, says Arturo Casadevall.

Last week, Duke University announced it would pay the US government US$112.5 million to settle claims that fraudulent data were used in dozens of research-grant applications. This is a communal punishment for an institution where the overwhelming majority of scientists are honest, hard-working individuals seeking knowledge for the good of humanity.

The lesson is that scientific misconduct can carry severe institutional costs. (And scientific ones: more than a dozen papers connected to this case have been retracted.) Duke, in Durham, North Carolina, has promised to improve its practices and administration, including setting up an advisory panel on research integrity and excellence.

These steps are laudable. But I worry that the seeds of misconduct, although they grow in only a very few individuals, are planted in the very heart of academic biomedical sciences.

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Commentary: a broader perspective on the RePAIR consensus guidelines (Responsibilities of Publishers, Agencies, Institutions, and Researchers in protecting the integrity of the research record) (Papers: Zoë H. Hammatt | December 2018)0

Posted by Admin in on April 14, 2019
 

The topic of responsibilities of publishers, agencies, institutions, and researchers in protecting the integrity of the research record is relevant for each of these stakeholders in the research enterprise. The RePAIR Consensus Guidelines reflect conversations on this important topic among diverse stakeholders rather than a single constituency. As such, they provide a starting point for additional discussion around improving communication among those handling retractions.

To advance the field beyond the Singapore and Montreal Statements and other referenced guidelines such as those produced by the Committee on Publication Ethics (COPE), the RePAIR Guidelines could serve as a springboard for articulating points of tension and offering solutions.

If these guidelines seek to offer specific recommendations on procedural aspects of interaction between stakeholders, however, extension beyond existing procedural guidelines (e.g., COPE and CLUE, referenced in the article) would be necessary. Such extension would require thorough literature review and additional consultation to ensure feasibility and a clear focus.

Hammatt, ZH (2018) Commentary: a broader perspective on the RePAIR consensus guidelines (Responsibilities of Publishers, Agencies, Institutions, and Researchers in protecting the integrity of the research record). Research Integrity and Peer Review. 20183:14 https://doi.org/10.1186/s41073-018-0056-0

Publisher (Open Access): https://researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-018-0055-1

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