by Maeve Luthin, JD, Professional Development Manager
There’s never a summer lull in science! Whether you are at the office basking in air conditioned glory or on vacation soaking up some rays, catch up with the latest news in research ethics by reading this week’s Research Ethics Roundup.
Do Clinical Trials Work?: In this New York Times op-ed piece, Clifton Leaf explores the high failure rate of randomized, controlled phase III clinical trials and their inability to provide investigators with information on why a drug may work for some patients but not others. Clifton explains that many companies are now designing smaller trials that recruit subjects who have particular genetic or molecular signatures and will produce results that will allow researchers to better understand why a drug may be effective.
Hungry Aboriginal Children, Adults Used as Nutritional Test Subjects: University of Guelph researcher Ian Mosby uncovered documents that revealed a long-standing, post-World War II nutritional experiment conducted by the Canadian government on malnourished aboriginal children living on remote reservations. The children involved were not told that they were participating in the study, which was to better understand the role of vitamins and minerals in a healthy diet. Some schools depressed milk rations, others used enriched flour that could not be sold legally in Canada, and others withdrew dental services. At the time of the study, guidelines for research with human subjects were just being developed.
Drug Research in China Falls Under a Cloud: An internal GlaxoSmithKline audit obtained by the New York Times reveals possible misconduct at its Shanghai research and development center. Improper clinical trial monitoring, inadequate consent documentation, bribery allegations, and failure to report the results of animal studies before beginning human trials are among the concerns raised in the report.
Opposition to NIH Chimp Plan: Chris Abee, director of MD Anderson’s animal research facility, expresses his opposition to the National Institute of Health’s plan to retire most chimpanzees used in federally-funded research. Abee argues that MD Anderson can provide better care and treatment for its chimps than Chimp Haven, the federal facility in Louisiana to which the chimps will eventually retire. The chimps at MD Anderson are currently the subjects of observational studies on aging, although some were subjects of a previous hepatitis C study.
Genetic Advance in Down’s Syndrome: University of Massachusetts Medical School researchers have “silenced” the extra copies of the chromosome that causes the symptoms of Down’s syndrome. This development will allow scientists to study the cellular basis for the condition, opening the possibility that further research could lead to genetic therapy. However, as the team explained, it could take decades of research before the findings translate to any clinical application.