ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)
Search
Generic filters
Exact text matches only
Search into
Filter by Categories
Research integrity
Filter by Categories
Human Research Ethics

Resource Library

Research Ethics MonthlyAbout Us

ResourcesBeneficence

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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.

Read the rest of this discussion piece

Prominent UCSD eye doctor ‘on leave’ after inewsource investigation – inewsource (Jill Castellano & Brad Racino | April 2019)0

Posted by Admin in on May 14, 2019
 

Dr. Kang Zhang, chief of eye genetics at the University of California San Diego, is “on leave” after an inewsource investigation exposed how the doctor put medical research subjects in harm’s way for years while pulling in millions of federal dollars for the institution.

This case demonstrates why an institution’s monitoring arrangements need to escalate consistent nonadherence and include random audits

In a new development, inewsource obtained an inspection report from the U.S. Food and Drug Administration that detailed more problems with one of Zhang’s studies. The report, compiled in 2016, described one incident in which Zhang poked a hole in a study participant’s eye with a needle, causing a cataract that had to be fixed with surgery.
.
The person wasn’t supposed to be enrolled in the study, according to the report, and the injury allegedly occurred because Zhang was in a hurry to take a trip to China.
.

Read the rest of this discussion piece

Friday afternoon’s funny – Faster recruitment0

Posted by Admin in on May 10, 2019
 

 

Cartoon by Don Mayne www.researchcartoons.com

A recruitment method might be faster and more effective (e.g. If 6 colleagues work together).  But is it superior and ethically superior?  If that depends on who you ask, then you probably should conclude it isn’t.

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

0