Controls on human research participants are “outdated”

In the United States the procedures that are supposed to protect human research participants are outdated and fail to work, a senior official at the National Institutes of Health has said.

“Not only does the research community and the public feel that the system has become burdensome and inefficient, but it has contributed to participant harms,” said Dr Ezekiel Emanuel, chief of the institutes' clinical bioethics department.

The present system of protecting human research participants requires fundamental changes, he said. Speaking earlier this month at a meeting of the President's Council on Bioethics (set up by in November last year by President George Bush), Dr Emanuel outlined a radical approach.

He summarised some of the present system's failures. Investigators are frustrated by delays in approval for studies. …