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Institutional Conflict of Interest Policies at U.S. Academic Research Institutions (Papers: David B. Resnik, et al | 2016)0

Posted by Admin in on January 11, 2019

Institutional conflict-of-interest policies at US academic research institutions, Resnik D.B, Ariansen, MS, Jamal, J. and Kissling, G.E.

Prof. Colin Thomson AM | AHRECS Profile |

The following is an excerpt of text posted to the AHREC subscribers’ area. The full commentary and other great research integrity and human research ethics items available for USD15/month. Because Patreon uses PayPal this can be paid on an institutional credit card and AHRECS can provide a receipt.

This informative although confined study shows that only 28% of United States academic research institutions have published or accessible policies about institutional conflicts of interest. Most had policies regarding conflicts of interest of faculty members and of members of institutional review boards.

In our work with Australian tertiary institutions, we have noticed a similar trend but have not assessed its extent. We agree with the authors of this resource that institutional conflicts of interest are important and need to be addressed publicly and specifically.
The authors refer to the Jesse Gelsinger incident involving the University of Pennsylvania and the subsequent enquiry that showed the likely influence of such conflicts. A more notorious example was that involving Dr Nancy Olivieri, the University of Toronto and the Toronto Hospital for Sick Children.  This was a long-running and complex saga that culminated in a 500 page report by the Canadian Association of University Teachers.  The importance of the issues and the challenges they present to those involved in ethical conduct of research are well described by Baylis.

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Institutional conflicts of interest (ICOIs) occur when the institution or leaders with authority to act on behalf of the institution have conflicts of interest (COIs) that may threaten the objectivity, integrity, or trustworthiness of research because they could impact institutional decision making. The purpose of this study was to gather and analyze information about the ICOI policies of the top 100 U.S. academic research institutions, ranked according to total research funding.

From May–June 2014, the authors attempted to obtain ICOI policy information for the top 100 U.S. academic research institutions from publicly available Web sites or via e-mail inquiry. If an ICOI policy was not found, the institutions’ online COI policies were examined. Data on each institution’s total research funding, national funding rank, public versus private status, and involvement in clinical research were collected. The authors developed a coding system for categorizing the ICOI policies and used it to code the policies for nine items. Interrater agreement and P values were assessed.

Only 28/100 (28.0%) institutions had an ICOI policy. ICOI policies varied among the 28 institutions. Having an ICOI policy was positively associated with total research funding and national funding ranking but not with public versus private status or involvement in clinical research.

Although most U.S. medical schools have policies that address ICOIs, most of the top academic research institutions do not. Federal regulation and guidance may be necessary to encourage institutions to adopt ICOI policies and establish a standard form of ICOI review.

Resnik, D. B., Ariansen, J. L., Jamal, J., & Kissling, G. E. (2016). Institutional Conflict of Interest Policies at U.S. Academic Research Institutions. Academic medicine: Journal of the Association of American Medical Colleges, 91(2), 242-6. DOI: 10.1097/ACM.0000000000000980
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More science than you think is retracted. Even more should be – The Washington Post (Adam Marcus and Ivan Oransky | December 2018)0

Posted by Admin in on January 9, 2019

Adam Marcus, the managing editor of Gastroenterology & Endoscopy News, and Ivan Oransky, distinguished writer in residence at New York University’s Arthur Carter Journalism Institute and vice president for editorial at Medscape, are co-founders of Retraction Watch.

The fall from grace wasn’t exactly swift, but it was stunning. Among stem cell researchers, Piero Anversa’s work trying to regrow the human heart in the 1990s and 2000s was legendary. That was then. In October, his former institutions, Harvard Medical School and its affiliate Brigham and Women’s Hospital, asked journals to retract 31 of his lab’s papers. That followed an agreement last year by the Brigham and other hospitals to pay the government $10 million to settle claims that Anversa and a colleague used bogus data to obtain their grant funding.

As dramatic as the Anversa case is, he is far from alone. This month, Anversa’s lab saw 13 papers retracted, but even if all journals honor the retraction requests, he won’t crack the top 10 for scientists who’ve had their articles pulled from the literature. Neither does Cornell University’s Brian Wansink, the food marketing researcher — and former media fixture — who experienced a similar fall over the past few years. The dubious honor for most retractions goes to Yoshitaka Fujii, a Japanese anesthesiologist who fabricated his findings in at least 183 papers, according to a 2012 investigation launched by journal editors and Japanese universities.

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(Australia) Reef company altered scientist’s report on crown-of-thorns program — even though he told them not to – ABC News (Michael Slezak | October 2018)0

Posted by Admin in on January 7, 2019

A company given millions of taxpayer dollars to cull the devastating crown-of-thorns starfish on the Great Barrier Reef altered a scientific report about the “poor management” of its own program, an ABC investigation can reveal.

The changes to the document were made despite the author demanding it be published “as is”, with a company employee suggesting it “wear the wrath” of the scientist.

Marine biologist Dr Udo Engelhardt told the ABC he was “baffled” as to why changes were made to his report.

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As China cracks down on faked drug trial data, US FDA abandons disclosure rule – Retraction Watch (Adam Marcus | October 2018)0

Posted by Admin in on January 5, 2019

The FDA has walked away from a 2010 rule that would have forced drug makers to disclose fabricated data to regulators.

As Bloomberg Law reported last week, the FDA has withdrawn the proposed rule, “Reporting Information Regarding Falsification of Data,” which would

require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study results, or in the course of proposing, designing, performing, recording, supervising, or reviewing studies that involve human subjects or animal subjects conducted by or on behalf of a sponsor or relied on by a sponsor. A sponsor would be required to report this information to the appropriate FDA center promptly, but no later than 45 calendar days after the sponsor becomes aware of the information. This proposal is necessary because ambiguity in the current reporting scheme has caused confusion among sponsors. The proposed rule is intended to help ensure the validity of data that the agency receives in support of applications and petitions for FDA product approvals and authorization of certain labeling claims and to protect research subjects.

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