Like FDA, the Office of Human Research Protections is part of the Department of Health and Human Services (HHS).
In a letter Wednesday to HHS Secretary Michael Leavitt, Grassley said officials at the Office of Human Research Protections had told his investigators that they believed the "ongoing FDA-approved clinical trial is unethical."
Spokesmen for the FDA and Northfield Laboratories did not respond Friday to telephone messages requesting information about the study.
Arthur Caplan, director of the University of Pennsylvania Center for Bioethics, said federal rules allowing clinical investigators to waive informed consent requirements are "intended to be very, very narrow."
In effect, he said, a patient in a life-threatening condition who is not conscious maybe deemed to have consented for use of the only means available to save his or her life.
"But it's hard to imagine somebody continuing to consent for the use of PolyHeme, once you get to the hospital," Caplan said.
On the Web:
Information on clinical trials, www.clinicaltrials.gov.
Jeff Nesmith's email address is email@example.com.