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European universities dismal at reporting results of clinical trials – Nature (Nic Fleming | April 2019)0

Posted by Admin in on September 11, 2019
 

Analysis of 30 leading institutions found that just 17% of study results had been posted online as required by EU rules.

Failing to post the results of a clinical trial is not only a technical breach, it is a waste of resources, places an unwarranted burden on volunteers, is a waste of resources and is a public health issue.  Does your institution follow-up to check if results have been reported?  Is action taken if it hasn’t?

Many of Europe’s major research universities are ignoring rules that require them to make public the results of clinical trials.

A report published on 30 April found that the results of only 162 of 940 clinical trials (17%) that were due to be published by 1 April had been posted on the European Union’s trials register. The 30 universities surveyed are those that sponsor the most clinical trials in the EU. Fourteen of these institutions had failed to publish a single results summary.

If three high-performing UK universities are excluded from the figures, the results of just 7% of the trials were made public on time. Campaigners say the resulting lack of transparency harms patients by undermining the efforts of doctors and health authorities to provide the best treatments, slows medical progress and wastes public funds.

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What universities can learn from one of science’s biggest frauds – Nature (Holly Else – June 2019)0

Posted by Admin in on September 3, 2019
 

Detailed analysis of misconduct investigations into huge research fraud suggests institutional probes aren’t rigorous enough.

By day, Andrew Grey studies bone health. But over the past few years, he’s developed another speciality: the case of one of science’s most prolific fraudsters.

From 1996 to 2013, Yoshihiro Sato, a Japanese bone-health researcher plagiarized work, fabricated data and forged authorships — prompting retractions of more than 60 studies in the scholarly literature so far. Grey and colleagues at the University of Auckland in New Zealand and the University of Aberdeen, UK, are among the researchers who have raised concerns about Sato’s work over the past decade or so, and they have studied the case in detail — in particular, how universities involved in the research investigated concerns about his work and allegations of misconduct.

At the World Conference on Research Integrity in Hong Kong from 2 to 5 June, Grey’s team described its years-long efforts to clean up Sato’s literature, and presented its analysis of the inquiries conducted by four universities in Japan and the United States ensnared in the scandal (the team published its analysis of three investigations in a paper in February1). Grey says their findings provide evidence to support a growing view in the academic community: that university investigations into research misconduct are often inadequate, opaque and poorly conducted. They challenge the idea that institutions can police themselves on research integrity and propose that there should be independent organizations to evaluate allegations of research fraud should.

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Implementation of a responsible conduct of research education program at Duke University School of Medicine (Papers: Christian Simon, et al 02 June 2019)0

Posted by Admin in on September 2, 2019
 

ABSTRACT
Academic medical centers rarely require all of their research faculty and staff to participate in educational programs on the responsible conduct of research (RCR). There is also little published evidence of RCR programs addressing high-profile, internal cases of misconduct as a way of promoting deliberation and learning. In the wake of major research misconduct, Duke University School of Medicine (DUSoM) expanded its RCR education activities to include all DUSoM faculty and staff engaged in research. The program included formal deliberation of the Translational Omics misconduct case, which occurred at Duke. Over 5,000 DUSoM faculty and staff participated in the first phase of this new program, with a 100% completion rate. The article reports on the program’s development, challenges and successes, and future directions. This experience at Duke University illustrates that, although challenging and resource intensive, engagement with RCR activities can be integrated into programs for all research faculty and staff. Formal, participatory deliberation of recent cases of internal misconduct can add a novel dimension of reflection and openness to RCR educational activities.

KEYWORDS: Responsible conduct of research, research integrity, RCR education, ethics education

Simon, C., Beerman, R.W., Ariansen, J.L., Kessler, D, Sanchez, A.M, King, K., Sarzotti-Kelsoe, M., Samsa, G. Bradley, A., Torres, L., Califf, R. & Swamy G.K. (2019) Implementation of a responsible conduct of research education program at Duke University School of Medicine. Accountability in Research, 26:5, 288-310, DOI: 10.1080/08989621.2019.1621755
Publisher (Open Access): https://www.tandfonline.com/doi/full/10.1080/08989621.2019.1621755?cookieSet=1

Open consent, biobanking and data protection law: can open consent be ‘informed’ under the forthcoming data protection regulation? (Papers: Dara Hallinan & Michael Friedewald | 2015)0

Posted by Admin in on August 22, 2019
 

Abstract
This article focuses on whether a certain form of consent used by biobanks – open consent – is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection law is currently undergoing reform. The Proposed Data Protection Regulation is the culmination of this reform and, if voted into law, will constitute a new legal framework for biobanking. The Regulation puts strict conditions on consent – in particular relating to information which must be given to the data subject. It seems clear that open consent cannot meet these requirements. 4 categories of information cannot be provided with adequate specificity: purpose, recipient, possible third country transfers, data collected. However, whilst open consent cannot meet the formal requirements laid out by the Regulation, this is not to say that these requirements are substantially undebateable. Two arguments could be put forward suggesting the applicable consent requirements should be rethought. First, from policy documents regarding the drafting process, it seems that the informational requirements in the Regulation are so strict in order to protect the data subject from risks inherent in the use of the consent mechanism in a certain context – exemplified by the online context. There are substantial differences between this context and the biobanking context. Arguably, a consent transaction in the biobanking does not present the same type of risk to the data subject. If the risks are different, then perhaps there are also grounds for a reconsideration of consent requirements? Second, an argument can be made that the legislator drafted the Regulation based on certain assumptions as to the nature of ‘data’. The authors argue that these assumptions are difficult to apply to genetic data and accordingly a different approach to consent might be preferable. Such an approach might be more open consent friendly.

Hallinan, D. and M. Friedewald (2015). “Open consent, biobanking and data protection law: can open consent be ‘informed’ under the forthcoming data protection regulation?” Life Sciences, Society and Policy 11(1): 1.
Publisher (Open Access): https://lsspjournal.biomedcentral.com/articles/10.1186/s40504-014-0020-9

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