I have pasted part of an email that I received about the study below. This email sums up the study and gives additional resources. If you wish to opt-out of this study you can use the resources in the email or click on one of the links provided below. Other links below include more information than what is given in the email posted below, including the risks and benefits of the study.
Opt-out information
Background on the ROC
Infomation including risks and benefits
Subject Line: Notice of your potential involvement in emergency research study.
A team of University of Iowa investigators will be assessing the effectiveness of research treatments for people who experience severe trauma in out-of-hospital, emergency situations. The research will allow a comparison of the present standard intravenous fluid (a salt solution) with more concentrated fluids. The research does not involve blood or blood products.
You are a potential subject for this study if you suffer a serious, life-threatening injury. The nature of the research is such that unless you opt-out, you will be a potential subject for this study. If you have previously requested to opt out of ROC and have received the opt out materials, you do not need to request opt out materials again.
The investigators are part of the Resuscitation Outcomes Consortium (ROC), which is a multi-site research study funded by the U. S. National Institutes of Health, the Canadian Institutes of Health Research and the American Heart Association.
By law and ethical standards, medical research requires that anyone who participates in a study knows what the study involves and risks and benefits, if any. This is known as "prior informed consent." However, severely injured individuals are likely to be unconscious, in shock, or otherwise unable to provide informed consent.
If a spouse or legally authorized representative is present, they will be asked to give consent to proceed with a research treatment. If they refuse, the research treatment will not be given. However standard treatment will still be given.
If no spouse or legally authorized representative is present, ROC research will be conducted under federal regulations that allow for a special "Exception From Informed Consent For Emergency Research" in life-threatening situations. Consent for follow-up will be obtained after treatment, when the person is no longer in the emergency situation or when a legally authorized representative of the injured person is available. You may choose to pre-exclude yourself or "opt-out" from this research in advance. To do so, contact the study investigators as indicated below.
Nationwide, ROC involves public safety agencies, regional hospitals, community health care institutions, and medical centers and is expected to include as many as 15,000 patients over a three-year period. Approximately 288 individuals will be included through the UI arm of the study. All of the interventions to be tested in the program have been shown in smaller, single center studies to be safe and potentially life-saving.
UI Hospitals and Clinics is one of 10 medical centers in the U.S. and Canada selected to conduct the collaborative clinical trials. The Principal Investigator for the UI site is Richard Kerber, MD, professor of internal medical and emergency medicine at the UI Roy J. and Lucille A. Carver College of Medicine and a cardiologist with UI Hospitals and Clinics. The Co-Principal investigator is Dr. J. Steven Hata, Clinical Associate Professor of Anesthesiology and Director of the UIHC SICU. Dr. Dianne Atkins, Professor of Pediatrics is an investigator. Linda G. Moss, RN is the study coordinator and Alex Drum, NREMT-P is the paramedic liaison. Melanie Kenney, RN is the data guardian.
If you have 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, 340 CMAB, The University of Iowa, Iowa City, Iowa, 52242, 319.335.6564 or e-mail at
irb@uiowa.edu.
For more information about this research study, or to learn how to opt-out, contact the study coordinator at 319-384-8484 or 866-309-0838 (toll-free) or email
iowarocs@uiowa.edu or visit the Web site:
www.iowarocs.org.
