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

Resource Library

Research Ethics MonthlyAbout Us

ResourcesMedical research

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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

More detailed guidance on the inclusion/exclusion of retracted articles in systematic reviews is needed (Papers: July 2019)0

Posted by Admin in on August 20, 2019
 

A forced retraction will generally (but not always) point to something seriously wrong with a research output/project, so it is essential they don’t result in a distortion of knowledge and practice. This recent journal paper suggests a sensible approach.

There are currently no clear guidelines on how to proceed when a retracted article is selected in the systematic review process. The Cochrane handbook provides information only on how to identify retracted articles within the scientific literature, instead of clear guidance and criteria for inclusion in the systematic review or not [1]. Other guidelines for conducting systematic reviews do not address this topic [2,3]. Common sense would indicate the exclusion from a systematic review of a study that was retracted because of faked or unreliable data [4].
.

Faggion, C. M., Jr. “More detailed guidance on the inclusion/exclusion of retracted articles in systematic reviews is needed.” Journal of Clinical Epidemiology. https://doi.org/10.1016/j.jclinepi.2019.07.006
Publisher: https://www.jclinepi.com/article/S0895-4356(19)30573-6/abstract

(US) NIH probe of foreign ties has led to undisclosed firings-and refunds from institutions – Science (Jeffrey Mervis | June 2019)0

Posted by Admin in on August 17, 2019
 

An aggressive effort by the National Institutes of Health (NIH) to enforce rules requiring its grantees to report foreign ties is still gathering steam. But it has already had a major impact on the U.S. biomedical research community. A senior NIH official tells ScienceInsider that universities have fired more scientists—and refunded more grant money—as a result of the effort than has been publicly known.

Since August 2018, Bethesda, Maryland–based NIH has sent roughly 180 letters to more than 60 U.S. institutions about individual scientists it believes have broken NIH rules requiring full disclosure of all sources of research funding. To date, the investigation has led to the well-publicized dismissals of five researchers, all Asian Americans, at MD Anderson Cancer Center in Houston, Texas, and Emory University in Atlanta.

But other major U.S. research universities have also fired faculty in cases that have remained confidential, according to Michael Lauer, head of NIH’s extramural research program. And some have repaid NIH “hundreds of thousands of dollars” in grants as a result of rule violations, he says. “I can understand why [the universities] aren’t talking about it,” Lauer says. “No organization wants to discuss personnel actions in a public forum.”

Read the rest of this discussion piece

AMWA–EMWA–ISMPP joint position statement on predatory publishing (Papers: American Medical Writers Association, et al | July 2019)0

Posted by Admin in on August 12, 2019
 

The American Medical Writers Association (AMWA), the European Medical Writers Association (EMWA) and the International Society for Medical Publication Professionals (ISMPP) recognize the challenges to scientific publishing being posed by predatory journals and their publishers, which employ practices undermining the quality, integrity and reliability of published scientific research. This joint position statement complements several other sets of guidelines that have helped define the characteristics of a predatory journal1–

American Medical Writers Association, European Medical Writers Association & International Society for Medical Publication Professionals (2019) AMWA–EMWA–ISMPP joint position statement on predatory publishing,Current Medical Research and Opinion,35:9, 1657-1658,10.1080/03007995.2019.1646535
Publisher (Open Access): https://www.tandfonline.com/doi/full/10.1080/03007995.2019.1646535

0