This week’s Research Ethics Roundup reviews researchers’ efforts to learn about how traumatic brain injury affects women’s brains, the first CRISPR gene-editing human subjects trial, why patient groups object to changing FDA rules on off-label promotion, and scientists’ arguments for why living conditions for lab mice need to change.
Wanted: Women’s Brains — to Jump-Start Lagging Research on Female Concussions: In this STAT News article, Usha Lee McFarling examines new efforts to collect data on the effects of traumatic injury on women’s brains. Experts are concerned about the low number of women in traumatic brain injury studies on athletes as well as the number of brain studies done on aging women and those who have survived domestic abuse.
CRISPR Gene-Editing Tested in a Person for the First Time: In this Nature article, David Cyranoski highlights the work of Chinese researchers who are the first in the world to inject a patient with cells containing genes edited with the CRISPR–Cas9 technique. The researchers said they see this primarily as a trial designed to look at safety issues and will be monitoring the patients for adverse effects. One American researcher predicted that China’s advance will “trigger ‘Sputnik 2.0’, a biomedical duel on progress between China and the United States.”
FDA Spotlights Unapproved Use of Drugs, Medical Devices: Jen Christensen reports for CNN about a recent public hearing at the FDA in which medical device and drug companies argued that current rules regarding off-label promotion hurt their First Amendment rights to free speech. Patient advocacy groups at the hearing stated that drug and device companies should not be allowed to market their products for off label uses because they did not submit adequate safety and efficacy studies to the FDA on such uses.
No One Likes to Live Alone: Moving Toward Social Housing of Lab Animals: In this article published by ALN Magazine, Sara Capdevila and Helen Kelly argue that lab mice and rats in solitary housing show physiological changes due to the stress of their unnatural living situation. They point out that such changes can affect study results and make the case that communal housing is good not only for the animal but also the study itself. They interview researchers who point out that the ARRIVE Guidelines, which recommend reporting of how lab animals are housed, are still not being followed.