ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Resource Library

Research Ethics MonthlyAbout Us

ResourcesInternational

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(US) Participants In Rogue Herpes Vaccine Research Take Legal Action – KHN (Marisa Taylor | March 2018)0

Posted by Admin in on October 20, 2018
 

Three people injected with an unauthorized herpes vaccine by a Southern Illinois University researcher have filed suit against his company, demanding compensation for alleged adverse side effects from the experiments.

SIU professor William Halford, who died in June, had injected Americans with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without safety oversight that is routinely performed by the Food and Drug Administration or an institutional review board.

Two of the participants who filed the lawsuit, Elizabeth Erkelens and Ed Biel, received the vaccine in the Caribbean trial, according to the lawsuit. The third participant, Terry Graham, was injected in two Illinois hotel rooms, it states.

Read the rest of this discussion piece
About the lawyer Alan C. Milstein

How Much Editorial Misconduct Goes Unreported? – Scholarly Kitchen (Phil Davis | June 2018)0

Posted by Admin in on October 20, 2018
 

COPE Case #18-03, “Editors and reviewers requiring authors to cite their own work”  reads like a political thriller:

Working alone late one night, a staffer stumbles upon a decision letter in which a handling editor instructs an author to cite some of his papers. Intrigued, the staffer digs deeper and finds a pattern of systematic abuse that involves a gang of crony reviewers willing to do the handling editor’s misdeeds and evidence of strong-arming authors who put up any resistance. The staffer brings the ream of evidence to the Editor-in-Chief, who goes to the editorial board. Confronted by questions to explain himself, the handling editor resigns out of haughty indignation. Case closed. Or is it?

The issue of editorial coercion is a topic that deserves coverage in professional development for early career researchers and higher degree research candidates (and probably new supervisors as well).

All COPE cases are public, however, the texts are carefully edited to preserve anonymity. COPE is an industry advisory group, not a court of law. The purpose of publicizing cases is to educate, not adjudicate. We can only hope that the summary of actions provides a clear path of action for future staffers and editors dealing with similar cases of misconduct. Still, it makes me wonder just how common is editorial misconduct and whether the vast majority of cases, like similar power-abuse misconduct, goes unreported.
.

A 2012 survey of social sciences authors published in the journal Science, reported that one-in-five respondents said they were coerced by journal editors to add more citations to papers published in their journal. Not surprisingly, lower-ranked faculty were more likely to acquiesce to this type of coercion. A follow-up study in PLOS ONE confirmed that the practice of requesting additional citations to the journal was prevelant across disciplines, although much more frequent in marketing, information systems, finance, and management than it was in math, physics, political science, and chemistry. In these studies, the researchers limit coercive citation to the journal itself, assuming that its purpose was to inflate the journal’s Impact Factor. But what if its purpose was also to inflate citations to the editor himself or to a cartel of other participating journals?
.

Read the rest of this discussion piece

Davis, P. (2018) How Much Editorial Misconduct Goes Unreported? The Scholarly Kitchen, 21 June.
https://scholarlykitchen.sspnet.org/2018/06/21/much-editorial-misconduct-goes-unreported/

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.

Read the rest of this discussion piece

The Rise of Peer Review: Melinda Baldwin on the History of Refereeing at Scientific Journals and Funding Bodies – Scholarly Kitchen (Robert Harington | September 2018)0

Posted by Admin in on October 17, 2018
 

I  was recently given the opportunity to read a fascinating paper by Melinda Baldwin, (Books Editor at Physics Today magazine, published by the American Institute of Physics), entitled “Scientific Autonomy, Public Accountability, and the Rise of “Peer Review” in the Cold War United States” (Isis, volume 109, number 3, September 2018). Melinda is an accomplished historian of science, with a special emphasis on the cultural and intellectual history of science and scientific communication. Not only is her writing infectiously entertaining, the story itself is new, or at least it is new to me. It turns out that peer reviewing in scientific journals is a relatively recent construct, first emerging in the nineteenth century and not seen as a central part of science until the late twentieth century.

A great piece reflecting on the history of peer review that nicely contextualises current frustrations and future directions. A worthy inclusion in ‘further reading’ lists when speaking about peer review.

Melinda paints a picture of constant change in peer review, which perhaps provides a lesson for us all. Maybe this should be obvious, but there is no status quo in academic publishing, and while we may feel our moment is more important than those that have gone before, or those ahead of us, expectations and models are fluid, be you author, reviewer, publisher, institution, or funder.
.
In this interview I ask Melinda to talk about her article, and provide some more personal views on peer review topics of the moment.
.

Read the rest of this discussion piece

Page 1 of 18012345...102030...Last »