Ex-OHRP official sees forms, documents, training as major causes of IRB breakdowns; sponsors at risk. (Informed consent).(Office of Human Research Protections, Tom Pugilisi)

PHILADELPHIA -- Poor record-keeping, badly written consent forms and lack of training were cited by a former Office of Human Research Protections (OHRP) official as leading reasons many IRBs and clinical investigators are not protecting clinical trial subjects well, thus posing risks for trial sponsors.

Addressing a mid-November Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum, Tom Pugilisi, manager of healthcare consulting practice at PriceWaterhouseCoopers and former director of human subject protections at OHRP, said he has been particularly disturbed by spotty informed consent forms. "The biggest complaint from academic medical centers is consent forms with exculpatory language," he said, referring to legalese that intends to get institutions off the book from liability in …