The U.S. Department of Health & Human services has released a new interactive video aimed to better protect research subjects and reduce misconduct in clinical research, it announced this week.
"We suspect research misconduct in clinical research may be underreported because review of clinical research data often focuses on issues other than falsification, fabrication or plagiarism," Don Wright, M.D., acting director of the Office of Research Integrity (ORI), said in the announcement. Every year, the Office of Human Research Protections (OHRP) receives about 400 reports alleging violations of regulations enacted to protect human subjects who participate in research studies. Examples of violations include "the enrollment of ineligible subjects who may be harmed by research interventions, failure to obtain or to properly document informed consent, and the conduct of research without IRB review and approval."
"This training video has the potential to greatly reduce compliance violations by providing an engaging method to teach researchers how to properly protect the people who generously volunteer to participate in clinical trials," Jerry Menikoff, M.D., OHRP director, said. Announcement