Inspections and Audits

FDA Reduces Clinical Hold on Tekmira’s Ebola Treatment

Canadian biotech company Tekmira will restart a Phase I trial of its TKM-Ebola RNA interference therapy in the coming weeks, following the FDA’s downgrading of a partial clinical hold that allows the company to administer repeat doses not greater than 0.24 mg/kg/day. Read More

U. of Minn. Accused of Serious Human Research Errors

Consumer advocacy watchdog Public Citizen is calling for an in-depth investigation of alleged human subject protection violations at the University of Minnesota between 2011 and 2014 and revocation of the university’s human subjects research credentials. Read More

Doctor: Risk Comparison Trials Should Pose Minimal Risk

The Office of Human Research Protections’ recent proposal to classify risk-comparison trials as “greater than minimal risk” will force physicians and patients to engage in overly burdensome informed consent processes that are out of proportion to the scope of the trials themselves, a leading bioethicist says. Read More

NIH Wants Trial Sites to Use a Single IRB

Sponsors of multisite clinical trials should take greater advantage of their ability to use a single institutional review board, according to a draft policy that requires the practice for all NIH-supported domestic trial sites. Read More