-
The Food and Drug Administration (FDA) has now said that clinicians wishing to perform a fecal transplant for treatment of Clostridium difficile will have to obtain an investigational new drug (IND) application.
-
Bioethics, genetic research also addressed at annual conference
-
Too often, IRBs spend precious meeting time debating the merits of a studys scientific and other subjective fine points, overlooking issues that have a greater impact on human subject safety, experts say.
-
An issue that can frequently arise in the area of genomic research is what to do with incidental findings (IFs) discoveries concerning a research subject that are beyond the scope of the study, but could have potential health importance for the subject.
-
IRBs searching for highly effective ways to improve protocol submissions and enhance education and training efforts might check out the SWAT! program at Washington University in St. Louis.
-
In the age of smart phones, iPads, electronic checklists, text message reminders, and other tools, it would be easy to forget that sometimes the best solution is the simplest: no-tech. At least thats what one research and human subjects protection expert discovered when trying to find a way to improve IRB meeting and review quality.
-
IRB cheat sheet placemats provide IRB members with clear regulatory information for reference during IRB review meetings.
-
-
-
