["Human Research Protections Prerule Mandates Regs for Non-Govt. Studies," Report on Research Compliance, August 2011]
The report has a statement from Art Caplan:
“These are long-overdue changes,” Art Caplan, director of the Center for Bioethics at the University of Pennsylvania, told RRC. “The current system involves too much red tape and paperwork in proportion to the protection given to subjects. In some ways the system of human subjects protection — informed consent and review by IRBs [i.e., institutional review boards] — has been hijacked by legal concerns so that more attention is given to institutional and investigator protection than subject empower- ment. These changes help remedy that problem.”
Your humble blogger is also quoted, complaining about the lack of attention to the experience of other countries. I did overlook ANPRM's footnote 28: "Cribb R. Ethical regulation and humanities research in Australia: Problems and consequences. Monash Bioethics Rev 2004;23(3):39–57." Other than that, has anyone found references to the workings of ethics committees in other countries?