The question of whether to return incidental findings to research subjects is tricky. If a study team notices, say, an anomaly on a CT scan, or a blood test result indicative of a potential problem, should the participant be told of the finding? The participant’s wishes, and whether anything could be done in response to […]
M.I.T. scientist who had charges dropped tells his story
Gang Chen, the M.I.T. scientist who had been charged with failing to disclose ties to China only to see the charges dropped a year later, says he is uncertain if he will ever again feel safe applying for federal research grants, according to a recent New York Times story. He described what he experienced over […]
Cases involving accusations of China ties resolved
Two cases based on professors’ alleged ties with China, including one involving a former University of Arkansas at Fayetteville professor, have been resolved, according to recent news reports. Simon Ang, who used to work at UAF, pleaded guilty to a single count of making a false statement. Other changes related to alleged wire fraud were […]
New HRPP plan and IRB policy reflect return of EFIC research
The UAMS Human Research Protection Program Advisory Committee (yes, we have such a thing) recently approved revisions to the UAMS HRPP plan and a revised IRB policy allowing the resumption of so-called “planned emergency” or “exception from informed consent” (EFIC) research. In a nutshell, this type of research allows the participation of subjects without first […]
The importance of sharing data and peer review
The recent verdicts in the Elizabeth Holmes case, in which she was convicted on four fraud-related charges stemming from her blood-testing company, highlight the importance of peer review and data transparency, according to scientists interviewed for a recent publication in Nature. Holmes was the founder of Theranos, a company with a goal of creating technology […]
Former Harvard prof convicted on charges related to China ties
Former Harvard University Chemistry and Chemical Biology Department chairman Charles Lieber has been convicted on charges related to what law enforcement said was his failure to disclose his participation in some programs based in China, according to a news release from the US Attorneys Office in Massachusetts. He had been accused of failing to disclose […]
Research participation from a subject’s perspective
A participant in the Moderna COVID vaccine trial has some thoughts about trial participation; more precisely, he has some thoughts about why he stopped trial participation. His views were recently posted online here in STAT. In summary, he objects to participating in experiments that result in what he claims are large profits for pharma companies. […]
Paper retracted due to vulnerable population informed consent concerns
The journal Human Genetics has retracted a paper for reasons related to informed consent of vulnerable populations in China, the website of The Intercept reported recently. The paper reported on genetic variation among and within ethnic groups. The 38,000 subjects included Tibetans and Uyghurs in China, who, per the article, “almost certainly did not give proper consent.” […]
Tracking changes — mark only the current round of changes
When you’re revising a document that has already been revised and approved at least once before, please accept any previous changes and only then start tracking the current set of revisions. Making sure the previously approved changes no longer show as “new” will help the IRB discern what, exactly, you’re changing in this round of revisions. […]
Researching your own disease
Those attending PRIM&R’s Advancing Ethical Research conference this week were able to hear from Dr. David Fajgenbaum, a physician and also the author of Chasing My Cure. Fajgenbaum was in medical school when he first fell seriously ill, with what was eventually diagnosed as idiopathic multicentric Castleman disease. His experience, which included nearly dying five times, pushed […]