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Can dynamic consent facilitate the protection of biomedical big data in biobanking in Malaysia? (Papers: Mohammad Firdaus Abdul Aziz & Aimi Nadia Mohd Yusof | May 2019)0

Posted by Admin in on October 20, 2019
 

Abstract
As with many other countries, Malaysia is also developing and promoting biomedical research to increase the understanding of human diseases and possible interventions. To facilitate this development, there is a significant growth of biobanks in the country to ensure continuous collection of biological samples for future research, which contain extremely important personal information and health data of the participants involved. Given the vast amount of samples and data accumulated by biobanks, they can be considered as reservoirs of precious biomedical big data. It is therefore imperative for biobanks to have in place regulatory measures to ensure ethical use of the biomedical big data. Malaysia has yet to introduce specific legislation for the field of biobanking. However, it can be argued that its existing Personal Data Protection Act 2010 (PDPA) has laid down legal principles that can be enforced to protect biomedical big data generated by the biobanks. Consent is a mechanism to enable data subjects to exercise their autonomy by determining how their data can be used and ensure compliance with legal principles. However, there are two main concerns surrounding the current practice of consent in biomedical big data in Malaysia. First, it is uncertain that the current practice would be able to respect the underlying notion of autonomy, and second, it is not in accordance with the legal principles of the PDPA. Scholars have deliberated on different strategies of informed consent, and a more interactive approach has recently been introduced: dynamic consent. It is argued that a dynamic consent approach would be able to address these concerns.

Keywords
Biobanking, Autonomy, Data protection, Informed consent, Dynamic consent

Abdul Aziz, Mohammad Firdaus, and Aimi Nadia Mohd Yusof. 2019. Can dynamic consent facilitate the protection of biomedical big data in biobanking in Malaysia? Asian Bioethics Review 11 (2) 1-14.  https://doi.org/10.1007/s41649-019-00086-2.
Publisher: https://link.springer.com/article/10.1007%2Fs41649-019-00086-2

(US) Google and the University of Chicago Are Sued Over Data Sharing – New York Times (Daisuke Wakabayashi | June 2019)0

Posted by Admin in on October 17, 2019
 

SAN FRANCISCO — When the University of Chicago Medical Center announced a partnership to share patient data with Google in 2017, the alliance was promoted as a way to unlock information trapped in electronic health records and improve predictive analysis in medicine.

On Wednesday, the University of Chicago, the medical center and Google were sued in a potential class-action lawsuit accusing the hospital of sharing hundreds of thousands of patients’ records with the technology giant without stripping identifiable date stamps or doctor’s notes.

The suit, filed in United States District Court for the Northern District of Illinois, demonstrates the difficulties technology companies face in handling health data as they forge ahead into one of the most promising — and potentially lucrative — areas of artificial intelligence: diagnosing medical problems.

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(Australia) Unauthorised survey asked students to rate Chinese people out of seven – Sydney Morning Herald (Nick Bonyhady | September 2019)0

Posted by Admin in on October 13, 2019
 

An unauthorised survey delivered to students at the University of Sydney under the university’s official logo asked them to rate the attractiveness and intelligence of Chinese people out of seven.

It is interesting this story doesn’t mention the National Statement (2007 updated 2018), the Australian Code (2018) or research misconduct though this may be encapsulated by the reference to suspension and investigation. The reported questions raise concerns as to the merit of the work, respect, justice and the troubling spectre of the alt-right.

The survey was delivered by both paid and volunteer pollsters to students voting in student representative council elections at the university this week. It claimed to be “approved in principle by the University of Sydney’s ethics committee” and “endorsed by the political science department.”
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A University of Sydney spokeswoman said the university had “very strong concerns” about the content of the survey, which it was not aware of until contacted by the Herald on Wednesday, and how it was delivered.
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“An initial inquiry indicates ethics approval was not obtained for the study and our logo has been used without permission,” the spokeswoman said. “We are formally contacting the staff and student involved today to advise them the matter may be subject to disciplinary proceedings.”
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How to Boost Racial, Ethnic and Gender Diversity in Clinical Research (Report – Syneos: September 2019)0

Posted by Admin in on October 6, 2019
 

Why All Stakeholders Must OWN The Mission
Healthcare transformations take time—and the time lag has consequences.

While this item and the accompanying report are decidedly US-centric, the issues are fundamental and global.  AHRECS Consultant Nik Zeps will be part of a panel discussion at the clinical oncology meeting in Adelaide in November 2019 debating this for the Cancer Council Victoria.

It has been 25 years since Congress passed the National Institutes of Health Revitalization Act requiring federally funded clinical research programs to prioritize inclusion of women and minorities. Since then, both the NIH and the Food and Drug Administration have mounted numerous initiatives, including regulatory guidance aimed at shoring up the law’s intent.
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Despite parallel efforts by biopharmaceutical innovators, the demographics of clinical trials today still do not reflect the racial, ethnic or gender diversity of target patient populations around the world. This is true for trial subjects, of whom an estimated 83 percent are white. And it’s true for the race/ethnicity/gender representation of investigators at many trial sites as well.

As advanced health systems around the world enter an era of genomic and precision medicine, lack of diversity across the clinical research landscape is a daunting obstacle.

Access this discussion piece and report

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