Because we try to keep things simple at the IRB (or maybe we’re just simple folk), we’re thrilled to announce that we have created a resource that contains information that industry sponsors and external IRBs tend to ask for as we start up our site in multi-site studies. We’ve collated the responses to the questions […]

HIPAA regulations require certain safeguards for electronic access to and storage of Protected Health Information (PHI). The following platforms are HIPAA compliant, per a list provided by The People Who Handle These Things. (We got the list from the UAMS Office of Research Compliance (ORC), but we can’t remember who, exactly, gave the list to […]

Preliminary results from a COVID challenge trial involving 36 young adults should this trial design appears safe, according to a recent Reuters article. Challenge trials, in which participants are deliberately exposed to an agent that can make them ill, raise questions of whether such a trial design is ethical. One camp argues challenge trials are […]

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 […]

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 […]

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 […]

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 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 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 […]

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. […]