Blood product trial sparks informed consent debate

The FDA allows informed consent to be waived in emergency situations if other treatment is unavailable or unsatisfactory.

By Andis Robeznieks — Posted Dec. 6, 2004

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A test for a new blood substitute has created tension between groups seeking to save lives and those looking to preserve research ethics.

While some investigators hail PolyHeme, an oxygen-carrying liquid produced by Evanston, Ill.-based Northfield Laboratories Inc., as a potential lifesaver, others say clinical trials for the product -- which include waiving test subjects' informed consent -- could set a precedent for future abuses of the Food and Drug Administration's guidelines, which allow such waivers in life-threatening situations.

The FDA did approve the protocol for the trial but would not discuss the controversy because of its policy of avoiding comment on studies in progress. AMA policy allows waiving informed consent for emergency medicine research if eight conditions are met, including informing a community that the research is taking place.

The trial involves giving patients in hemorrhagic shock PolyHeme instead of saline at the scene of injury or during transport to the hospital.

Some bioethicists are concerned because the trial can go on for hours after the patient has been admitted to a hospital. They argue that the main reason for the waiver, that satisfactory treatment is not available, is no longer being met once patients are admitted and have access to blood.

"The issue is whether this study meets the letter and the spirit of the regulations," said Arthur R. Derse, MD, clinical professor of emergency medicine and director of medical and legal affairs for the Medical College of Wisconsin's Center for Bioethics.

Nancy M.P. King, professor of social medicine at the University of North Carolina in Chapel Hill, said this test could lead to granting more waivers with less justification.

But a co-investigator of the study, Mark E. Cichon, DO, director of emergency medical services at Loyola University Medical Center in Maywood, Ill., said that even if blood is available, consent might not be possible because of the subject's mental status.

"When you do informed consent, it's not simply asking for permission, it's a discussion and a dynamic process," he said.

Northfield issued a Nov. 18 statement saying the FDA and the review boards at 16 medical institutions had approved the research protocol. Two IRBs have not.

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External links

AMA policy on the waiver of informed consent for research in emergency situations (link)

Northfield Laboratories' blood substitute PolyHeme (link)

PolyHeme Blood Substitute Trauma Trial at Loyola University Health System (link)

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