Resuscitation Research Center
COVID-19 ANNOUNCEMENT: All medical infrastructure has been re-directed to COVID-19 clinical care. Accordingly, all clinical research below has been suspended indefinitely.
The Resuscitation Research Center is also a regional site for two NIH funded research networks: the Resuscitation Outcomes Consortium and the Neurological Emergencies Treatment Trials Network.
Listen to Dr. Aufderheide's interview on WUWM's Lake Effect NPR (National Public Radio) interview where he discusses how a collaborative partnership between the Medical College of Wisconsin and Milwaukee County EMS has improved prehospital medical care and outcomes in Southeastern Wisconsin.
BOOST3 Trial (may resume following COVID-19)
BOOST3 is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU). The study will determine the safety and efficacy of a strategy guided by treatment goals based on both intracranial pressure (ICP) and brain tissue oxygen (PbtO2) as compared to a strategy guided by treatment goals based on ICP monitoring alone. Learn more at boost3trial.org.
ACCESS Trial (Completed)Access to the cardiac catheterization laboratory in patients without ST-segment elevation myocardial infarction resuscitated from out-of-hospital ventricular fibrillation cardiac arrest (ACCESS) Find study results here.
Resuscitation Outcomes Consortium (ROC) (Completed)
What is ROC?
The Resuscitation Outcomes Consortium (ROC) is a clinical research network consisting of 10 Regional Clinical Centers throughout the United States and Canada, as well as a Data Coordinating Center. It was created to study better ways to treat people that have an out-of-hospital cardiac arrest or a severe traumatic injury.
Why is ROC research important?
Cardiac arrest and traumatic injury are important public health problems. Heart disease is the most common cause of death in North America. Over 350,000 out-of-hospital cardiac arrests occur each year in the United States. Of those, less than 10% survive. Life-threatening severe injury is the leading cause of death in North America for persons between the ages of 1 and 44 years, and one of the leading causes of death in those over the age of 65 years.
For more information, visit the ROC website.
ROC Brochure (English) (PDF) | ROC Brochure (Spanish) (PDF)
We respect the wishes of any member of our community who does not wish to be enrolled in an Exception from Informed Consent research study being conducted with Milwaukee County EMS Providers (MCEMS) and Flight for Life. In order to opt-out of these studies, you can request an opt-out bracelet or necklace (shown below) free of charge. This bracelet or necklace applies to all of our studies currently being conducted by Milwaukee County EMS and Flight for Life. MCEMS and Flight for Life providers are trained to NOT enroll citizens wearing this bracelet or necklace in any research study. To obtain an opt-out bracelet or necklace, you can either call the Resuscitation Research Center at (414) 805-6493 or email us at RRC@mcw.edu. Your bracelet or necklace will be immediately shipped to you free of charge to the specified address.
ROC Clinical Trials at MCW (All ROC Trials Completed)
Amiodarone (PM101), Lidocaine, or Placebo for treatment of recurrent ventricular fibrillation or pulseless ventricular tachycardia in patients with out-of-hospital cardiac arrest.learn more
Continuous Chest Compressions (CCC) CPR versus Standard AHA 30:2 CPR in patients with out-of-hospital cardiac arrest.learn more
Prehospital Tranexamic Acid (TXA) use for treatment of patients with Traumatic Brain Injury (TBI).learn more
Pragmatic trial of Airway Management in Out-of-Hospital Cardiac Arrest.learn more
Neurological Emergencies Treatment Trials Network (NETT) (All NETT Trials Completed
What is NETT?
The NIH has created a Neurological Emergencies Treatment Trials (NETT) Network to conduct large simple trials to reduce the burden of very acute injuries and illnesses affecting the brain, spinal cord, and peripheral nervous system. The network recognizes and seeks to explore the special narrow window of opportunity that seems to exist in treating neurologic damage from a variety of pathologies ranging from stroke to traumatic brain injury to seizures to meningitis. The study of very rapid interventions will have to be implemented by paramedics in the field, or by physicians in the Emergency Department. This network provides the basis for conducting efficient studies in these environments.
The mission of the Neurological Emergencies Treatment Trials (NETT) Network is to improve outcomes of patients with acute neurologic problems through innovative research focused on the emergent phase of patient care.
Exception From Informed Consent
The Resuscitation Research Center conducts some research studies under the Exception From Informed Consent Guidelines by the Food and Drug Administration. View FDA Exception from Informed Consent for Studies Conducted in Emergency Settings Information.
Per these federal regulations, the Resuscitation Research Center does the following for all Exception From Informed Consent studies:
- Conduct a Community Consultation (survey) of residents in the Milwaukee area to obtain their attitudes and opinions regarding whether this study should be completed in Milwaukee. The Institutional Review Board (IRB) at MCW, closely reviews these results to determine if the Milwaukee community approves of the study.
- Conduct public notification: Prior to the start of the study, notices are placed in several newspaper publications, radio announcements and web postings.
Visit studies listed above for specific public notices. In addition, we provide a way for anyone who wishes not to be enrolled in studies being conducted with Milwaukee County EMS to opt-out. See the ROC Opt-Out information listed under the above Resuscitation Outcomes Consortium (ROC).
NETT Clinical Trials at MCW (All NETT Trials Completed)
[Title 21, Volume 1]
[Revised as of April 1, 2006]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 50 -- PROTECTION OF HUMAN SUBJECTS
Subpart B--Informed Consent of Human Subjects
Sec. 50.24 Exception from informed consent requirements for emergency research.
(a) The IRB responsible for the review, approval, and continuing review of the clinical investigation described in this section may approve that investigation without requiring that informed consent of all research subjects be obtained if the IRB (with the concurrence of a licensed physician who is a member of or consultant to the IRB and who is not otherwise participating in the clinical investigation) finds and documents each of the following:
(1) The human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness of particular interventions.
(2) Obtaining informed consent is not feasible because:
(i) The subjects will not be able to give their informed consent as a result of their medical condition;
(ii) The intervention under investigation must be administered before consent from the subjects' legally authorized representatives is feasible; and
(iii) There is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the clinical investigation.
(3) Participation in the research holds out the prospect of direct benefit to the subjects because:
(i) Subjects are facing a life-threatening situation that necessitates intervention;
(ii) Appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence support the potential for the intervention to provide a direct benefit to the individual subjects; and
(iii) Risks associated with the investigation are reasonable in relation to what is known about the medical condition of the potential class of subjects, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity.
(4) The clinical investigation could not practicably be carried out without the waiver.
(5) The proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator has committed to attempting to contact a legally authorized representative for each subject within that window of time and, if feasible, to asking the legally authorized representative contacted for consent within that window rather than proceeding without consent. The investigator will summarize efforts made to contact legally authorized representatives and make this information available to the IRB at the time of continuing review.
(6) The IRB has reviewed and approved informed consent procedures and an informed consent document consistent with 50.25. These procedures and the informed consent document are to be used with subjects or their legally authorized representatives in situations where use of such procedures and documents is feasible. The IRB has reviewed and approved procedures and information to be used when providing an opportunity for a family member to object to a subject's participation in the clinical investigation consistent with paragraph (a)(7)(v) of this section.
(7) Additional protections of the rights and welfare of the subjects will be provided, including, at least:
(i) Consultation (including, where appropriate, consultation carried out by the IRB) with representatives of the communities in which the clinical investigation will be conducted and from which the subjects will be drawn;
(ii) Public disclosure to the communities in which the clinical investigation will be conducted and from which the subjects will be drawn, prior to initiation of the clinical investigation, of plans for the investigation and its risks and expected benefits;
(iii) Public disclosure of sufficient information following completion of the clinical investigation to apprise the community and researchers of the study, including the demographic characteristics of the research population, and its results;
(iv) Establishment of an independent data monitoring committee to exercise oversight of the clinical investigation; and
(v) If obtaining informed consent is not feasible and a legally authorized representative is not reasonably available, the investigator has committed, if feasible, to attempting to contact within the therapeutic window the subject's family member who is not a legally authorized representative, and asking whether he or she objects to the subject's participation in the clinical investigation. The investigator will summarize efforts made to contact family members and make this information available to the IRB at the time of continuing review.
(b) The IRB is responsible for ensuring that procedures are in place to inform, at the earliest feasible opportunity, each subject, or if the subject remains incapacitated, a legally authorized representative of the subject, or if such a representative is not reasonably available, a family member, of the subject's inclusion in the clinical investigation, the details of the investigation and other information contained in the informed consent document. The IRB shall also ensure that there is a procedure to inform the subject, or if the subject remains incapacitated, a legally authorized representative of the subject, or if such a representative is not reasonably available, a family member, that he or she may discontinue the subject's participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. If a legally authorized representative or family member is told about the clinical investigation and the subject's condition improves, the subject is also to be informed as soon as feasible. If a subject is entered into a clinical investigation with waived consent and the subject dies before a legally authorized representative or family member can be contacted, information about the clinical investigation is to be provided to the subject's legally authorized representative or family member, if feasible.
(c) The IRB determinations required by paragraph (a) of this section and the documentation required by paragraph (e) of this section are to be retained by the IRB for at least 3 years after completion of the clinical investigation, and the records shall be accessible for inspection and copying by FDA in accordance with 56.115(b) of this chapter.
(d) Protocols involving an exception to the informed consent requirement under this section must be performed under a separate investigational new drug application (IND) or investigational device exemption (IDE) that clearly identifies such protocols as protocols that may include subjects who are unable to consent. The submission of those protocols in a separate IND/IDE is required even if an IND for the same drug product or an IDE for the same device already exists. Applications for investigations under this section may not be submitted as amendments under 312.30 or 812.35 of this chapter.
(e) If an IRB determines that it cannot approve a clinical investigation because the investigation does not meet the criteria in the exception provided under paragraph (a) of this section or because of other relevant ethical concerns, the IRB must document its findings and provide these findings promptly in writing to the clinical investigator and to the sponsor of the clinical investigation. The sponsor of the clinical investigation must promptly disclose this information to FDA and to the sponsor's clinical investigators who are participating or are asked to participate in this or a substantially equivalent clinical investigation of the sponsor, and to other IRB's that have been, or are, asked to review this or a substantially equivalent investigation by that sponsor.
[61 FR 51528, Oct. 2, 1996]
Resuscitation Research Center
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