What are the ethical considerations with this kind of research?
Clinical studies of treatments are only approved when the best available scientific evidence cannot determine whether one treatment is better than another (equipoise). In this case, there are scientists and physicians who advocate for the different treatments, but no agreement that one approach is better than the other.
People who may be part of a research study usually are told about the benefits and risks of the study (and their legal rights) before they receive any study intervention. Patients generally sign a consent form before they participate in the study. In an emergency, there is not enough time to get consent from the patient or their family. Thus EMS research must be done with an exemption to informed consent. Before the exemption can be granted, the public must be told about the research and be able to give their opinion about it.
After the public has been notified, a trial can proceed without informed consent. Efforts are made following the emergency to obtain informed consent from the patient if they are capable of doing so, or from their legally authorized representative if they are not.
In addition to demanding the above features be met, the ROC has several layers of research review in place to safeguard patient safety:
- An independent group of experts reviews the scientific value of the proposed trial.
- A separate expert group authorized by the National Institutes of Health reviews the safety of the trial and monitors the safety of subjects through out the study.
- An expert in medical ethics affiliated with ROC reviews the proposed research.
- If a new device or drug is to be studied, the U.S. Food & Drug Administration (FDA) reviews and approves the study before it starts.
- At each site a review group evaluates and monitors the research locally. This final review and approval focuses on the local issues of how best to consult with the public regarding both the study treatment(s) and outcome(s) and notify them about the research.
If someone were unconscious due to a cardiac arrest or severe injury would they be enrolled in a ROC research study?
Yes, the goal of the ROC community-wide EMS resuscitation studies is to enroll all eligible patients at the earliest possible time, when treatment is most promising.
If someone were enrolled in a ROC research study, how would the person or family be made aware of this?
Participating EMS providers notify the ROC research staff when a patient is enrolled in a research protocol. A ROC research staff member will then approach the patient or their representative in person, by phone or via letter. The study will be described to them at that time.