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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Friday afternoon’s funny – Safety reports0

Posted by Admin in on February 2, 2018

Cartoon by Don Mayne

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

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.

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):

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
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.

Read the rest of this discussion piece

Friday afternoon’s funny – Study Coordinator action figure0

Posted by Admin in on January 26, 2018

Cartoon by Don Mayne

We know a few good souls that excel in this too often unsung role and chief investigators who we hope realise how fortunate they are to work with someone so committed.