FDA Reviewing Informed Consent Rules
Waiving informed consent in emergencies could get harder in the wake of a controversial trial
The Food and Drug Administration is seeking to clarify and strengthen rules under which clinical emergency research can be conducted without the informed consent of patients. The agency has issued new draft guidance
on the topic and plans to hold a public hearing
on Oct. 11.
The new guidance details the requirements and procedures for conducting clinical experiments under a 1996 emergency waiver rule
(21 CFR 50.24). The rule allows research without the informed consent of incapacitated subjects or their legal representatives in life-threatening situations in which informed consent is not feasible and available treatments are unproven or unsatisfactory. IRBs must have previously consulted with community representatives and publicly disclosed that incapacitated individuals can be enrolled without their consent.
The guidance provides far more detail than was previously offered on the roles of sponsors, clinical investigators and IRBs, and also broadens and clarifies the meaning of community consultation and public disclosure.
FDA Deputy Commissioner Janet Woodcock suggested in a statement
that the guidance was a routine review of an aging regulation. "On the 10-year anniversary of this regulation, it is appropriate that we review the regulation and get the perspectives of those who participated in such studies to make sure that emergency research is being carried out in a scientifically sound and ethical manner," she said.
However, the announcement that the rule is being revisited comes on the heels of a clinical trial
that had been widely criticized
for allegedly violating emergency research ethics and regulations.
Some bioethicists criticized that study - a Phase III trial of the blood substitute PolyHeme - because the subjects, who were in hemorrhagic shock, were not required to give consent. Other critics
said the sponsor, Evanston, Illinois-based Northfield Laboratories, and various IRBs had failed to adequately inform and consult with local communities before the trial began. The trial involved 720 patients at trauma centers in 18 states. It ended on July 31.
Northfield spokeswoman Sophia Twadell maintained that the trial was ethical and in compliance with federal regulations. The company plans to release topline data from the study by the end of the year and seek FDA marketing clearance under "fast-track" status during the first half of 2007, she told The Scientist
Critics of the PolyHeme trial welcomed the FDA's new guidance and the planned hearing.
"Basically, the FDA is on the right track," said Nancy M. King, professor of social medicine at the University of North Carolina-Chapel Hill, who has worked with her colleagues to draw attention
to the alleged flaws in the PolyHeme trial. The new guidance seems to offer "a remarkable degree of thoroughness in what counts as good community consultation and what doesn't," she noted.
Senate Finance Committee Chairman Charles Grassley (R-Iowa), another vocal critic of the trial, said he is pleased that the FDA is reviewing the rules. "Anything that can be done to make sure people know they may be a guinea pig before they become a guinea pig in a clinical trial is welcome news," he told The Scientist
in an E-mail. "More transparency and clarity will benefit everyone."
Interested parties can submit comments on the draft guidance until Oct. 30. Those wishing to participate in the public hearing must register by Sept. 20.
Links within this article
FDA Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research
Conduct of Emergency Clinical Research; Public Hearing
Food and Drug Administration 21 CFR Part 50 - Protection of Human Subjects
FDA press release: "FDA Takes Close Look at Experience Gained from Regulations Allowing Emergency Research With An Exception from Informed Consent Requirements," Aug. 29, 2006.
Clinical trials listing, Safety and efficacy of PolyHeme in hemorrhagic shock following traumatic injuries beginning in the pre-hospital setting.
T. Agres, "Controversial blood trial continues," The Scientist
, May 8, 2006.
G. McGee, "A bloody mess," The Scientist
, 20:24, August 2006.
K. Kipnis et al, "An open letter to IRBs considering Northfield Laboratories' PolyHeme trial," American Journal of Bioethics, May-June 2006.