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China tightens its regulation of some human gene editing, labeling it ‘high-risk’ – Science (Dennis Normile | February 2019)0

Posted by Admin in on May 19, 2019
 

In the wake of the shocking news that one of its scientists had produced genetically altered babies, the Chinese government this week issued draft regulations that would require national approval for clinical research involving gene editing and other “high-risk biomedical technologies.” Although some Chinese researchers welcome the move to tighten oversight, there are worries that the rules could impose a burden on areas of genetic research that are not so controversial.

“I am happy to see the national regulations regarding new biomedical technologies; I think this makes relevant policy more clear,” says Wei Jia, a medical oncologist who is involved with an ongoing trial using gene editing to modify cancer patient T-cells at the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School in China.

The regulations are in response to the late November 2018 claim by He Jiankui, then of Southern University of Science and Technology in Shenzhen, China, that he had altered the DNA embryos in a way that would give the babies and their descendants resistance to HIV. This approach is called germline engineering—it can involve changing DNA in embryos or sperm or eggs—and is banned in many countries, by law or regulation. He’s effort, using a technique called CRISPR, resulted in twin girls born last fall; one more baby, he said, is on the way. The experiment earned He worldwide condemnation for prematurely using a still glitchy technique that might negatively affect the babies’ development and health in a medically unnecessary and unjustified intervention.

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Chinese government funding may have been used for ‘CRISPR babies’ project, documents suggest – STAT (Jane Qiu | February 2019)0

Posted by Admin in on May 19, 2019
 

BEIJING — Three government institutions in China, including the nation’s science ministry, may have funded the “CRISPR babies” study that led to the birth last November of two genetically modified twin girls, according to documents reviewed by STAT.

These findings appear to support what many researchers inside and outside China have suspected since scientist He Jiankui revealed the births in late November, sparking international condemnation for violating scientific guidelines against the use of gene-edited human embryos to start pregnancies. “I don’t think He Jiankui could have done it without the government encouragement to press ahead” with research they thought would merit a Nobel Prize, said Jing-Bao Nie, a bioethicist at the University of Otago in New Zealand.

If the documents are correct, they would suggest China is supporting research that the U.S. and other countries consider unethical, and raise doubts about the preliminary conclusion of a government investigation that He acted mostly on his own. That inquiry, which was led by the Guangdong provincial health commission and involved the science ministry and the National Health Commission, determined that He raised funding for the experiment on his own without official endorsement. It also concluded that He forged an informed-consent form and violated scientific ethics and Chinese regulations, according to the official Xinhua News Agency.

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Australian Mental Health Consumer and Carer Perspectives on Ethics in Adult Mental Health Research (Papers: Alyssa R. Morse, et al | April 2019)0

Posted by Admin in on May 5, 2019
 

Abstract
Barriers to research arise when national ethical guidelines governing the inclusion of consumers in mental health research are implemented at the local level. Equivalent guidelines for research involving carers are not available. A social science investigation of Australian mental health consumer and carer perspectives on research ethics procedures was conducted in two interlinked stages: (a) a discussion forum with consumers, carers, and lived-experience researchers and (b) in-depth interviews with consumers and carers. Data collection and analysis drew strongly on methodological features of grounded theory. Privacy, confidentiality, and stigmatizing ethics procedures were key issues for consumer and carer participants. Recommendations for research practice include the following: considering the impact of information sharing on participants’ relationships and adopting individual-focused approaches to managing research risks.

Keywords:
caregiver; carer involvement; consumer involvement; mental health; research ethics; service user

Morse, A. R., Forbes, O., Jones, B. A., Gulliver, A., & Banfield, M. (2019). Australian Mental Health Consumer and Carer Perspectives on Ethics in Adult Mental Health Research. Journal of Empirical Research on Human Research Ethics. https://doi.org/10.1177/1556264619844396
Publisher: https://journals.sagepub.com/doi/abs/10.1177/1556264619844396

Genomic Research Through an Indigenous Lens: Understanding the Expectations (Nanibaa’ A. Garrison, et al | August 2019)0

Posted by Admin in on April 2, 2019
 

Abstract

Indigenous scholars are leading initiatives to improve access to genetic and genomic research and health care based on their unique cultural contexts and within sovereign-based governance models created and accepted by their peoples. In the past, Indigenous peoples’ engagement with genomic research was hampered by a lack of standardized guidelines and institutional partnerships, resulting in group harms. This article provides a comparative analysis of research guidelines from Canada, New Zealand, Australia, and the United States that pertain to Indigenous peoples. The goals of the analysis are to identify areas that need attention, support Indigenous-led governance, and promote the development of a model research policy framework for genomic research and health care that has international relevance for Indigenous peoples.

Expected final online publication date for the Annual Review of Genomics and Human Genetics Volume 22 is August 30, 2019. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

Garrison, N. A., Hudson, M., L. Ballantyne, LL., Garba, I. Martinez, A., Taualii, M., Arbour L., Caron, NR. and Rainie, SC. (2019). Genomic Research Through an Indigenous Lens: Understanding the Expectations. Annual Review of Genomics and Human Genetics 20(1)
https://www.annualreviews.org/doi/abs/10.1146/annurev-genom-083118-015434

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