The public has a right to know more about the risks and benefits of emergency research performed on victims of trauma, cardiac arrest and stroke without their informed consent, experts told federal health officials Wednesday.
The Food and Drug Administration convened a public hearing to discuss whether decade-old regulations guiding the ethical conduct of emergency research are adequate.
"There is a certain tension that we have tried to balance between beneficence and respect for persons," said Dr. Sara Goldkind, the FDA's senior bioethicist. "One question we are asking today is, 'Should these tensions be balanced any differently than they are today?'"
Emergency research has been allowed by the FDA under very restricted circumstances since 1996. Research that began in 2004 on a blood substitute recently renewed the controversy, in part because real blood was withheld from trauma patients enrolled in the trial without their consent.
"Emergency research can help us determine whether or not a treatment truly works, but it comes at a price," said Dr. Jeffrey Shuren, the FDA's assistant commissioner for policy, referring to the tension between the two principles of doing good and respecting people.
Since 1996, 21 informed consent-exception emergency research studies have been completed, planned or remain in progress, Goldkind said. The studies have enrolled approximately 2,700 patients.
In public testimony, experts said emergency research is vital even when consent cannot be obtained, but the FDA should require more in-depth public engagement before the studies begin.
The "failure to conduct a robust and transparent process of community consultation will undermine public trust in the conduct of emergency research," said Dr. Robert Nelson, a Children's Hospital of Philadelphia pediatrician. He is joining FDA as a pediatric research ethicist.
Researchers now must disclose to communities and consult with them regarding where emergency trials are planned, and include discussion of the risks and benefits of the research, the FDA says. Anyone not wanting to participate can opt out, typically by choosing to wear a special bracelet.
Real-life experience suggests such outreach efforts often fall short.
Paula Knudson, a human subject protection expert at The University of Texas Health Science Center at Houston, called current opt-out approaches a "fiction."
"Community consultation has been consistently problematic. We have essentially no evidence to show it is effective in its goals and some evidence to show otherwise," said Dr. Michelle Biros of the Society for Academic Emergency Medicine and Coalition of Acute Resuscitation Researchers.
Biros cited the case of a drug being tested to sedate cocaine users who had overdosed. Efforts to recruit even a single cocaine addict to attend community consultation meetings failed, she said.
"They are currently poorly attended and they poorly reflect the community," Dr. Charles Cairns of the American College of Emergency Physicians said of the meetings.
Informed consent requirements can be waived by a local oversight board for a clinical trial that includes patients who cannot consent to treatment and are in a life-threatening situation where available treatments are unproven or unsatisfactory and study of a drug, device or medical procedure is necessary to determine whether it's safe and effective, the FDA says.
On Wednesday, some experts suggested creating a national board to oversee such research.
The FDA, in announcing the meeting, said it was particularly interested in hearing from patients, patient advocacy groups, company representatives, ethicists and others. However, all but one of the 14 registered speakers were doctors, most of them emergency researchers.
The FDA failed to post the agenda for the meeting, perhaps explaining in part the limited turnout.
Goldkind said the FDA still hoped to receive a "broad array" of written comments from interested parties.
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