OHRP and Standard-of-Care Research

The U.S. Office of Human Research Protection (OHRP) has just issued draft guidance on the elements of informed consent it will require when research is conducted to evaluate treatment options within the current standard of care. The draft guidance (available at www.hhs.gov/ohrp/newsroom/rfc/comstdofcare.html) is open for public comment until December 23, 2014.OHRP regulations should provide a practical, fair approach to research on treatments that study subjects might have received from their physicians in the course of normal practice. However, this draft guidance is written in complex and ambiguous legalistic language that makes it difficult to determine exactly what behavior will . . .