April 30, 2007
Emergency Heart Research Is Topic Of May 7 Community Meeting
A community meeting will be held Monday, May 7, to inform and seek feedback from people who live, work and travel in Johnson County and West Branch about a University of Iowa research study on treating people with cardiac arrest (when the heart stops beating) in emergency, out-of-hospital settings.
At the meeting people can learn how to pre-exclude themselves from, or opt out of, the study.
The meeting will take place at 7 p.m. Monday, May 7, in Meeting Room A of the Iowa City Public Library, 123 S. Linn St. in Iowa City.
The study aims to find out whether more people will survive cardiac arrest if one or two treatment approaches are added to current cardiopulmonary resuscitation (CPR) methods.
The study treatments focus on a device that increases blood flow during CPR and on the amount of CPR delivered before EMS providers check the heart rhythm to determine if a defibrillatory shock is needed.
The study, called PRIMED, involves UI Hospitals and Clinics and Mercy Hospital in Iowa City. The area communities included in this cardiac study are: Coralville, Hills, Iowa City, Lone Tree, North Liberty, Oxford, Solon, Tiffin, University Heights and West Branch. These communities are served by the Johnson County Ambulance Service, which is part of the study.
The treatments will be investigated in the communities listed above as part of the Resuscitation Outcomes Consortium (ROC), a multi-site research study funded by the National Institutes of Health, the Canadian Institutes of Health Research and the American Heart Association.
The meeting will detail the purpose, study treatments, possible risks and benefits, and other study specifics. Audience members will fill out surveys at the meeting and have the opportunity to ask questions and provide additional feedback.
Nationwide, ROC involves public safety agencies, regional hospitals and medical centers and is expected to include as many as 15,000 patients over a three-year period.
By law and ethical standards, medical research requires that anyone who participates in a study know what the study involves and risks and benefits, if any. This is known as "prior informed consent." However, because persons in this ROC PRIMED cardiac study will be in cardiac arrest, they will be unable to provide informed consent.
Therefore, ROC will be conducted under federal regulations that allow for a special "Exception From Informed Consent" in life-threatening situations. Instead, when the person is no longer in the emergency situation, or when a legally authorized representative of the injured person is available, they will be informed of the study."
Community members who want to pre-exclude themselves or "opt out" must receive a wallet card and/or wristband from the UI. First-responders will know that the card or band excludes a person from the study.
This PRIMED study on emergency cardiac care in out-of-hospitals settings is different from a previously announced ROC study on emergency trauma care in out-of-hospital settings. However, if you previously opted out of that trauma study, you also will be excluded from this cardiac-PRIMED and all current and future ROC studies. Your wristband or wallet card will exclude you from the ROC studies.
For more information, contact the study coordinator toll free at 866-309-0838 or 319-384-8484 or mailto:email@example.com, or visit the Web site: http://www.iowarocs.org.
Additional information is provided in this March 24, 2006, news release issued by the National Heart, Lung, and Blood Institute of the NIH: http://www.nhlbi.nih.gov/new/press/06-03-24.htm.
If you have any questions, concerns or complaints about your rights as a research subject or about research-related injury, please contact Martha Jones or Suzanne Bentler in the Human Subjects Office at 340 College of Medicine Administration Building, Iowa City, Iowa 52242 or by phone at 319-335-6564 or email at firstname.lastname@example.org.
STORY SOURCE: Health Science Relations, University of Iowa, 5137 Westlawn Lawn, Iowa City, IA 52242
MEDIA CONTACT: Becky Soglin, 319-335-6660, email@example.com.