Human Experimentation – It has not been that long… I am shocked, that people are shocked by the press releases and apologies last Friday. Web link: http://www.nytimes.com/2010/10/02/health/research/02infect.html?_r=1 The problem is that gonorrhea and syphilis are...
I noticed that Outsourcing Pharma had a blip on Investigators’ frustrations with IRB review timelines. See below to a link to the full article: http://www.outsourcing-pharma.com/Clinical-Development/IRB-delays-a-frustration-for-investigators The thought that an IRB...
Have you seen the OHRP training videos on YouTube? What a great idea; and with an average of a 1,000 views, I guess many of you agree. It’s a great way to train new board members, PIs and the community about human research. The topics cover IRB membership, Informed...
Ethics of Safety Studies for Marketed Drugs Even the Average Joe couldn’t have missed the discussions regarding the safety risks of Avandia. FDA is again in a tough spot and looking for answers. Traditionally, Industry was not to make safety claims about drugs, just...
It comes back to matching skill sets for increased efficiency. Odds are the Board chair was chosen, or elected, based on their leadership skills. Or, was this person chosen based on their keen ability to organize documentation per standard procedures to ensure...
