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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.

Read the rest of this discussion piece

Management of Data and Information in Research (NHMRC An Australian Code (2018) good practice guide | June 2019)0

Posted by Admin in on September 29, 2019
 

A guide supporting the Australian Code for the Responsible Conduct of Research

aContents

1. Introduction 1

2. Responsibilities of institutions 1
2.1 Provision of training for researchers 2
..2.2 Ownership, stewardship and control of research data and primary materials 2
2.3 Storage, retention and disposal 3
2.4 Safety, security and confidentiality 3
2.5 Access by interested parties 4
2.6 Facilities 4

3. Responsibilities of researchers 4
3.1 Retention and publication 6
3.2 Managing confidential and other sensitive information 7
3.3 Acknowledging the use of others’ data 7
3.4 Engagement with relevant training 7

4. Breaches of the Code 7

Additional Resources 8

Access the good practice guide

(China) A 10-year follow up of publishing ethics in China: what is new and what is unchanged (Papers: Katrina A. Bramstedt & Jun Xu | September 2019)0

Posted by Admin in on September 13, 2019
 

Abstract

Background
Organ donation and transplantation in China are ethically complex due to questionable informed consent and the use of prisoners as donors. Publishing works from China can be problematic. The objective of this study was to perform a 10-year follow up on Chinese journals active in donation and transplant publishing regarding the evolution of their publishing guidelines.

Methods
Eleven Chinese journals were analyzed for 7 properties: (1) ethics committee approval; (2) procedure consent; (3) publishing consent; (4) authorship criteria; (5) conflict of interest; (6) duplicate publication; and (7) data integrity. Results were compared with our 2008 study data. Additionally, open access status, impact factor, and MEDLINE-indexing were explored.

Results
Most journals heightened the ethical requirements for publishing, compared to the results of 2008. All 11 now require their published manuscripts to have data integrity. Ten of 11 require ethics committee approval and informed consent for the publication of research studies, whereas in the original study only 2 journals evidenced these requirements. Nine of 11 have criteria for authorship, require conflict of interest disclosure, and forbid duplicate publishing. None of the journals have a policy to exclude data that was obtained from unethical organ donation practices. Nine of 11 journals are MEDLINE-indexed but only 2 are open-access.

Conclusions
Most journals have improved their general ethical publishing requirements but none address unethical organ donation practices.

Keywords:
China; Informed consent; Organ donation; Publishing; Research ethics; Research integrity

Bramstedt, K. and Xu, J. (20019) (China) A 10-year follow up of publishing ethics in China: what is new and what is unchanged. Research Integrity and Peer Review 4(17) https://doi.org/10.1186/s41073-019-0077-3.
Publisher (Open Access): https://researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-019-0077-3

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