PUBLIC COMMENTS SUGGEST CHANGES TO RULE ON EMERGENCY EXCEPTIONS TO INFORMED CONSENT

Public comments obtained from the FDA's Division of Dockets Management show that while many organizations are generally supportive of the agency's draft guidance on conducting emergency clinical research without informed consent from participants, more work needs to be done.

The guidance, first issued in 2000 and updated earlier this year, was the subject of an FDA public hearing Oct. 11. Of all the suggestions for improving it, the requirement for community consultation before starting such research generated the most discussion. Current methods of getting community input on research "have not resulted in broad representation," since "few people attend public meetings and those who do are likely to be non-representative," the Society for Academic Emergency Medicine and the Coalition of Acute Resuscitation Researchers said.

The Council on Government Relations added that "additional examples or further discussion of assessing the effectiveness of community consultation plans and practices could be helpful." The American College of Emergency Physicians suggested that research be done on the "many unresolved issues [that] remain, such as which community to consult, who counts as a community representative or member to be consulted with and what is the purpose of this consultation."

The American Heart Association's Emergency Cardiovascular Care Committee offered a template to help institutional review boards (IRBs) handle the subject of community consultation and the related public disclosure requirement. The Federation of American Hospitals said that local IRBs should be favored over commercial IRBs in clinical trials conducted under the guidance, and that the IRBs "should be encouraged to attend at least one public consultation."