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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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

Advancing research integrity: a programme to embed good practice in Africa (Papers: Anke Rohwer, et al | 2019)0

Posted by Admin in on October 18, 2019
 

Abstract
In Africa, training programmes as well as institutional policies on research integrity are lacking. Institutions have a responsibility to oversee research integrity through various efforts, including policies and training. We developed, implemented and evaluated an institutional approach to promote research integrity at African institutions, comprising a workshop for researchers (“bottom-up”) and discussions with senior faculty on institutional policies (“top-down”). During the first day, we facilitated a workshop to introduce research integrity and promote best practices with regards to authorship, plagiarism, redundant publication and conflicts of interest. We used a variety of interactive teaching approaches to facilitate learning, including individual and group activities, small group discussions and case-based learning. We met with senior faculty on the following day to provide feedback and insights from the workshop, review current institutional policies and provide examples of what other research groups are doing. We evaluated the process. Participants actively engaged in discussions, recognised the importance of the topic and acknowledged that poor practices occurred at their institution. Discussions with senior researchers resulted in the establishment of a working group tasked with developing a publication policy for the institution. Our approach kick-started conversations on research integrity at institutions. There is a need for continued discussions, integrated training programmes and implementation of institutional policies and guidelines to promote good practices.

Keywords:
Research integrity, Africa, institution, publication policy, workshop

Rohwer, A., Wager, E. & Young, T. (2019). Advancing research integrity: a programme to embed good practice in Africa. Pan African Medical Journal. 33. 10.11604/pamj.2019.33.298.17008.
Publisher (Open Access): http://www.panafrican-med-journal.com/content/article/33/298/full/

A publisher wants to destigmatize retractions. Here’s how – Retraction Watch (Ivan Oransky | September 2019)0

Posted by Admin in on October 15, 2019
 

It’s no secret that retractions have a stigma, which is very likely part of why authors often resist the move — even when honest error is involved. There have been at least a few proposals to change the nomenclature for some retractions over the years, from turning them into “amendments” to a new taxonomy.

Erica Boxheimer, data integrity analyst at EMBO Press, and Bernd Pulverer, chief editor of The EMBO Journal and head of scientific publications for the Press, have suggested a related solution, which builds on a 2015 proposal:

We proposed to use the term “withdrawal” instead of the canonical “retraction” for an author‐initiated retraction based on “honest mistakes”. We are now using the terms “retraction” and “withdrawal” as formally distinct content types across EMBO Press in the hope that “withdrawal” attracts less stigma and encourages self‐correction. 

Read the rest of this interview and discussion piece

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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