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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

The Rush to Publication: An Editorial and Scientific Mistake – JAMA Editorial (Howard Bauchner | September 2017)0

Posted by Admin in on February 3, 2018
 

The world moves at a far faster pace than even a decade ago. Instantaneous access to electronic communication via email and social media is available 24 hours a day, virtually anywhere in the world, on the ground and in the air, with video and audio on demand. Thus, no one ever needs to be—or ever is—disconnected from the world.

The speed of communication has clearly affected clinical and laboratory research. There appears to be an increasing rush to publish, or at least to make the results of studies immediately publicly available. It is unclear if flawed science is more common than in the past, but the number of accounts of serious problems with scientific reports appears to be increasing, with more high-profile retractions and increasing numbers of retractions with replacements (major inadvertent errors with a change in the findings and conclusions).1 However, because more research is being published, it is difficult to obtain precise numerator (retractions) and denominator data (all research conducted, published and unpublished).2

Nonetheless, concerns about the reproducibility of laboratory-based experiments3 and the need to reanalyze clinical data4 certainly suggest increasing challenges regarding the quality and transparency of research. High-visibility examples leave an impression of questionable science that is likely contributing to the public discourse over the meaning and definition of facts.

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Friday afternoon’s funny – Safety reports0

Posted by Admin in on February 2, 2018
 

Cartoon by Don Mayne www.researchcartoons.com.

Anyone involved in the conduct, research ethics review, oversight or governance of large multi-site clinical trials know well the uncomfortable reaction to the arrival of safety reports en masse and the unspoken temptation to direct them to the circular filing cabinet in the corner. And if it’s a multi-jurisdictional pharmacological trial times the amount of paper and frequency by at least 5.

Rethinking Informed Consent in Biobanking and Biomedical Research: a Taiwanese Aboriginal Perspective and the Implementation of Group Consultation (Papers: Chih-hsing Ho | 2017)0

Posted by Admin in on February 1, 2018
 

Abstract
The current informed consent mechanism is based mainly on the rationale of individualism, particularly for its emphasis on autonomy and self-determination. However, in biobanking and genetic research, research findings may pose a risk of harm to the collective, quite aside from a particular individual. Under this circumstance, individual consent needs to be supplemented by other mechanisms, such as group consent obtained from the relevant group or community. In Taiwan, the inclusion of Taiwanese aborigines in biobanking and genetic research challenges the conventional wisdom of individual consent-taking, which overlooks the significance of collective involvement in decision-making. This paper discusses the rationale of the group consent requirement in Taiwan, which seeks to include Taiwanese aborigines’ perspectives, and the related measures that have been pronounced to implement group consultation. It is further argued that consent procedures should not be transactional in being primarily focused on types of information that is to be communicated. Rather, it should be a process that ensures comprehension, empowerment and trust.

Keywords
Informed consent, Biobanking, Biomedical research. Group consultation, Taiwanese aborigines, Human Subjects Research Act

Ho, C.-h. (2017). “Rethinking Informed Consent in Biobanking and Biomedical Research: a Taiwanese Aboriginal Perspective and the Implementation of Group Consultation.” Asian Bioethics Review 9(4): 353-365.
Publisher (Open Access):  https://link.springer.com/article/10.1007/s41649-017-0037-5

Authorship and Team Science – JAMA Network (Editorial | Phil Fontanarosa, et al | December 2017)0

Posted by Admin in on January 29, 2018
 

The complexity, scope, and scale of scientific research have expanded substantially. During the past several decades, there has been increasing prevalence of large, international, multicenter clinical trials; multidisciplinary investigations involving interventional studies or observational research; and studies that combine large data sets (“big data”) from multiple cohorts or research consortia and use sophisticated analytic methods, such as in some studies involving genomic research or machine learning. This trend toward increasingly collaborative research involving multiple investigators and research groups has been referred to as group science, ensemble science, or more commonly, team science.1 How authors and nonauthor collaborators can be identified in publications to ensure appropriate credit and recognition of team science is evolving, can be challenging, and is of great importance to the scientific community and individual investigators.

This editorial is a reliable and useful example for grappling with the issues associated with very large collaborations. It is a recommended inclusion in institutional research integrity resource libraries and has been added as essential reading in the AHRECS Resource Library

Team science has real and potential advantages, including the ability to bring expertise and experience from numerous investigators or disciplines to address an important research topic from multiple perspectives and the ability to collect or combine data from various sites or cohorts to generate large data sets to address scientific questions efficiently and effectively. Team science is likely to increase with the growth of research networks and consortia and the continued emergence of big data and data sharing.2
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Team science also creates potential challenges, including identifying the optimal group of investigators to address the study questions of interest; rigorously addressing issues of heterogeneity in attempts to combine data or data sets; ensuring engagement, appropriate participation, and supervision of all members of the scientific team; reaching agreement and consensus regarding presentation and interpretation of study findings; and appropriately recognizing the contributions of individual members of the research team in scientific publication.
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