How many times have you heard a reference to “The Beecher Report”? This report is considered a foundational document underpinning human research ethics, but it’s unclear how many of us who work in human subject research have had a chance to actually read and discuss it. Because we want to give the UAMS human research […]
Institutional Review Board Members
Reminders for our Institutional Review Board reviewers about policies, using Clinical Research Administration (CLARA), and other news. Feel free to click on this blog even if you aren’t on the Institutional Review Board. You may get some pointers about what the Institutional Review Board is looking for when it reviews your studies.
HIPAA-compliant platforms that can be used for UAMS research
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 […]
COVID challenge trial indicated safe
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 […]
Returning genetic findings: Some subjects don’t want to know
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. […]