U.S. weighs emergency research without consent

Emergency medical research without patient consent should be allowed in some cases where quick treatment is critical and getting permission is difficult or impossible, researchers on Wednesday told U.S. officials who are reconsidering the rules for such studies.

The issue gained new attention this year when the Food and Drug Administration was criticized for letting Northfield Laboratories Inc. study an experimental blood substitute, PolyHeme, in trauma patients without getting their permission first.

Several emergency medicine and trauma specialists, who dominated the speakers at an FDA public meeting on the issue, said waiving the consent requirement was needed in some cases.

“We as a society have a moral and ethical obligation to find more effective and safe therapies. It’s not possible to conduct life-saving research in the emergency setting without an exemption to informed consent,” said Dr. Joseph Ornato, who spoke on behalf of the National Institutes of Health Resuscitation Outcomes Consortium.

The FDA is revisiting a 1996 regulation that allows consent to be waived in certain cases. Generally, patients need to have a life-threatening condition that requires immediate attention and be unconscious or otherwise unable to give permission.

The agency has received 56 requests for emergency research without consent over the past decade, said FDA bioethicist Dr. Sara Goldkind. The FDA approved 21 of them, and about 2,700 patients had been treated in the studies as of April, she said.

The trials are supposed to include safeguards such as oversight by independent review boards and consultation with the local community. Available treatments must be deemed “unproven and unsatisfactory.”

Criticism of the Polyheme study has focused in part on whether the alternative - blood transfusions - is unproven and unsatisfactory. Senate Finance Committee Chairman Charles Grassley on Wednesday asked the U.S. health secretary to convene an advisory committee to consider that question.

Grassley said internal correspondence showed there was strong disagreement within the Department of Health and Human Services about whether that was the case.

“It is of paramount importance that the United States government stands on solid ethical and scientific ground before sanctioning experimental research on its citizens without their consent,” the Iowa Republican said in a letter to HHS Secretary Mike Leavitt.

Northfield has said its study met FDA requirements and took patient safety into account.

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