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August 9, 2007

Emergency treatment research at U-M Health System prepares to enter a new phase

Studies involving exemption from informed consent can now be proposed; public will be asked for input on studies before they can proceed

ANN ARBOR, MI – For patients who suffer strokes, heart attacks, seizures, trauma and other medical emergencies, the treatment they receive in the first minutes can be a matter of life and death. But discovering new and better treatments for these emergencies can be difficult.

Emergencey signNow, in an effort to find better treatments for serious medical emergencies, the University of Michigan Health System has embarked on a new phase of advanced research in emergency medical care.

For the first time, U-M researchers can seek permission to study potentially beneficial treatments on patients with life-threatening emergency conditions who are unconscious or otherwise unable to give permission, or who don’t have a family member or legal representative available to give permission before treatment starts.

The first study, a CPR trial being done jointly with St. Joseph Mercy Health System and Huron Valley Ambulance, will begin a community consultation process soon.

This type of study offers an important opportunity to improve an area of medicine that needs better options: the life-or-death care that takes place in the first minutes or hours after an injury or sudden illness. It is difficult to find improved treatments for these trauma situations due to the standard requirement that patients (or their representatives) give “informed consent”: permission before enrolling in a study, based on their understanding of the research’s possible risks and benefits.

So, to protect patients’ rights and safety, each of the studies under the new provision will receive special scrutiny and oversight from U-M’s ethical review board for medical studies, the Medical School Institutional Review Board or IRBMED. In addition, members of the public will be able to get information and give input on each study before it begins, and in some cases may be able to “opt out” of the study.

U-M is actually beginning this type of research a decade after the U.S. Food and Drug Administration first began to allow it, under a ruling called “Exception From Informed Consent” or EFIC. Other hospitals and ambulance companies across the country have performed EFIC research since 1996, to assess treatments for stroke, cardiac arrest and other emergency conditions. One such study led to the approval of automated external defibrillators for use in homes and public places such as malls, airports and schools.

After reviewing the national experience, the U-M IRBMED decided earlier this year that it would now consider proposals from U-M researchers who wish to conduct EFIC studies. "The IRBMED opted not to review these types of studies at U-M when the EFIC regulation first came out, as no one had experience with this type of research,” explains Michael Geisser, Ph.D., interim co-chair of IRBMED.

“However, this area of research is clearly important, and we can now draw from the experience of others to try and improve the quality of this type of research conducted at U-M,” continues Geisser, an associate professor of physical medicine and rehabilitation.

Adds John Weg, M.D., IRBMED co-chair and professor emeritus of internal medicine, “EFIC studies go through a more rigorous review process compared to other research, as the study team is also required to consult with the community of persons who may become subjects in the research, and inform them of the findings, in addition to the usual scientific and ethical review. The IRBMED is composed of community members and scientists who carefully evaluate these studies, and we now know more about the positive and negative aspects of past EFIC studies that we can use to improve future EFIC studies done here.”

Continues IRBMED vice-chair Alan Sugar, M.D., a professor of ophthalmology, “While we recognize that the complex ethical and regulatory issues involved in EFIC research are likely to generate diverse opinions, we feel that properly designed studies are likely to answer important questions and promote improved treatments for emergency medical problems.”

Dr. BarsanThe chair of the Department of Emergency Medicine at the U-M Medical School welcomes the IRBMED decision. We urgently need to find better options for emergency patients, in order to save more lives. But we also have a solemn duty to protect people’s rights and safety,” says William Barsan, M.D., FACEP, who is also a noted emergency care researcher. “Our studies under this exemption will put rights and safety first, while still allowing us to evaluate new treatments or compare existing ones in situations where every minute counts.”

First studies: CPR devices and medications for children experiencing severe seizures
The first studies seeking approval from the U-M IRBMED will involve CPR-assisting devices, and a comparison of two commonly used medicines for severe seizures in children. Public meetings on both studies will be held later this summer as part of the “community consultation” phase that is required before a study can receive approval.

The CPR study is being led by Robert Domeier, M.D., FACEP, medical director of the Washtenaw/ Livingston Medical Control Authority and an emergency medicine physician at St. Joseph Mercy Health System who also holds a U-M faculty position in emergency medicine. Mark J. Lowell, M.D., an associate professor of emergency medicine at U-M, is also involved, as are all the ambulance companies and fire department rescue personnel who respond to medical emergencies in Washtenaw County.

The trial, called ResQ, will test two different devices that may improve the survival of cardiac-arrest patients who receive cardiopulmonary resuscitation, or CPR. One of the devices is already a standard part of CPR care in Europe. Although patients will be treated with the devices before they reach either the U-M or St. Joseph Mercy emergency department, both hospitals will participate in the study by gathering follow-up data on how well patients do after they reach the hospital.

Public meetings seeking comment on the ResQ study will be conducted this summer, including Community Consultation Meetings on Aug. 20 at the Ann Arbor District Library’s Downtown Branch at 6 p.m.; Aug. 22 in Saint Joseph Mercy Livingston Hospital’s community rooms at 7 p.m. in Howell; and Aug. 23 at St. Joseph Mercy Hospital’s education center auditorium in Ypsilanti at 7 p.m. One session will be videotaped for broadcast on Ann Arbor Community Television. More details will also be available on the web sites of UMHS and St. Joseph Mercy Health System.

The second study being proposed under the new U-M EFIC provision will compare two drugs that are already given to children who are experiencing “status epilepticus” – severe, prolonged and life-threatening seizures that can be brought on by epilepsy, head injury or other factors.

The two drugs, lorazepam and diazepam, are used in emergency rooms around the country every day. But the study seeks to determine in a scientific manner which drug is more appropriate to use in pediatric seizure patients, by randomly assigning children to receive one or the other.

Rachel Stanley, M.D., MHSA, heads the study at U-M; ten other hospitals around the nation, including Children’s Hospital of Michigan in Detroit, are also taking part. Stanley directs the Great Lakes Node of the Pediatric Emergency Care Applied Research Network, and is an assistant professor of emergency medicine and pediatrics at U-M.

For the pediatric seizure study, public meetings and consultation with specific areas of the community, including schools and epilepsy groups, will be held this summer. Parents, guardians and other legally authorized representatives who do not wish for their child to be enrolled in the study will be able to notify study personnel via the Internet, phone or fax. More information on the study is available at www.dcchildrens.com/seizurestudy.

Many other emergency research studies are already under way at U-M, but they are not being performed under the FDA’s EFIC regulation. These studies typically involve the use of drugs for which maximum effect does not depend on immediate administration, therefore allowing time for patients or their legal representatives (including spouses, adult children and non-relatives involved in their medical decision-making) to read and understand information about the study, and sign a consent form.

Other U-M researchers are preparing to go before the IRBMED to propose EFIC studies.

Some of these studies might involve patients who are transported to the U-M emergency department for care. Others may involve patients being treated at the dozens of hospitals participating in the Neurological Emergency Treatment Trials (NETT) network, which is headed by Barsan and funded by a $7.7 million, five-year grant from the National Institute for Neurological Diseases & Stroke.

All potential EFIC trials led by U-M researchers will have to meet the conditions set out by IRBMED and by the FDA before they are allowed to proceed with IRBMED review, community consultation and enrollment. In each case, researchers must show that they will attempt to get consent from the patient or a legal representative if there is time.

The IRBMED will only approve studies under EFIC when it is impossible to get an informed consent from patients prior to enrollment because their medical condition does not allow it, and if the treatment being studied must be given before the patient’s representative can give informed consent. Also, there must be no way to identify the individual patients who are likely to be eligible for the study ahead of time.

Additionally, EFIC can only be granted for trials that will treat a life-threatening medical condition for which current treatments are unproven or unsatisfactory. The trials must involve a treatment that is believed to offer the possibility of benefit to the patient, based on pre-clinical research, and that is believed to have minimal risks given the patient's life-threatening circumstances. And, researchers must show that the research could not be conducted within the "therapeutic window" (the time span when the treatment must be given in order to provide benefit) without an EFIC.

More information

Clinical research at U-M is available on the U-M Engage web site

IRBMED’s guidance to U-M researchers on EFIC

1996 guidance from FDA about EFIC

U.S. Office of Human Research Protections has a public information page

Written by Kara Gavin

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