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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Scientists ‘may have crossed ethical line’ in growing human brains – The Guardian (Ian Sample | )0

Posted by Admin in on October 22, 2019
 

Debate needed over research with ‘potential for something to suffer’, neuroscientists say

Neuroscientists may have crossed an “ethical rubicon” by growing lumps of human brain in the lab, and in some cases transplanting the tissue into animals, researchers warn.

The creation of mini-brains or brain “organoids” has become one of the hottest fields in modern neuroscience. The blobs of tissue are made from stem cells and, while they are only the size of a pea, some have developed spontaneous brain waves, similar to those seen in premature babies.

Many scientists believe that organoids have the potential to transform medicine by allowing them to probe the living brain like never before. But the work is controversial because it is unclear where it may cross the line into human experimentation.

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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

 For Vulnerable Populations, the Thorny Ethics of Genetic Data Collection – UnDark (Adrian Pecotic | September 2019)0

Posted by Admin in on October 10, 2019
 

To be equitable, genetics research needs more diverse samples. But collecting that data could exploit the very people scientists intend to help.

IN 2009, RESEARCHERS collected DNA from four elderly men in Namibia, each from one of the many San indigenous communities scattered across southern Africa. A year later, analyses of the men’s DNA were published in the journal Nature — alongside that of South African human rights activist Desmond Tutu. The intention, in part, was to increase the visibility of southern, indigenous Africans in genetic-based medical research. Soon after, a nongovernmental organization (NGO) representing indigenous minorities in Southern Africa took issue with the consent procedures used to gather the data and wrote to Nature’s editors accusing the paper’s authors of “absolute arrogance, ignorance, and cultural myopia.”

The San case highlights the thorny ethics of collecting genetic data. Yet today, to make medicine more equitable, scientists see the importance of sampling DNA from more diverse populations. Most genetic research uses DNA from descendants of Europeans, which means the related medical applications — such as genetic tests to see the likelihood of developing a certain disease, called polygenic risk assessments — can only benefit those populations. In 2018 in the United States, for example, the National Institutes of Health launched All of Us, a research program that aims to collect DNA, electronic health records, and other data, from about one million Americans with emphasis on including many different groups of people.

“When we do genetic studies, trying to understand the genetic basis of common and complex diseases, we’re getting a biased snapshot,” said Alicia Martin, a geneticist at the Massachusetts General Hospital and the Broad Institute, a biomedical and genomics research center affiliated with Harvard and MIT.

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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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