By David G. Krefetz, DO, MBA, FAPA, FACN, CPI, Director, Pediatric Center of Excellence, Early Development Services, PRA Health Sciences
It has always been difficult to find appropriate and adequate test subjects for clinical trials involving complex mental health issues such as schizophrenia. The FDA’s stricter requirements for informed consent have made this challenge even more difficult.
“Informed consent is more than just a signature on a form,” the FDA states in a recent communication to the industry. In fact, the agency regards informed consent as a process of information exchange that may include subject recruitment materials, verbal instructions, question/answer sessions, and measures of subject understanding. Furthermore, institutional review boards (IRBs), clinical investigators, and research sponsors are all listed by the FDA as responsible for ensuring the informed consent process is adequate. “Thus, rather than an endpoint, the consent document should be the basis for a meaningful exchange between the investigator and the subject,” the agency adds.
I couldn’t agree more.