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Emergency Medicine

Charlotte Houston and Milwaukee Prehospital EMS Research Node Center (CHaMP)

Charlotte, Houston, and Milwaukee Prehospital (CHaMP) is a node of PECARN composed of three diverse EMS agencies that collectively respond to nearly 350,000 EMS calls per year including 25,000 pediatric calls. Our Mission is to conduct innovative and relevant collaborative pediatric prehospital research.

The three CHaMP EMS affiliates are dedicated to providing high-quality prehospital care and believe that research is an important aspect of providing high-quality care. Each agency has previously participated in successful prehospital randomized clinical trials and has cultivated a culture that values research. Together, the CHaMP investigators and EMS agencies aim to find the answers to important questions that will improve the health of children who access the emergency response system.

The CHaMP Investigators are also dedicated to increasing the scope, quality, and quantity of pediatric EMS research. Therefore, CHaMP is developing online research education as well as promoting opportunities and science through our .

This project is supported by the Health Resources and Services Administration (HRSA), Maternal and Child Health Bureau (MCHB), Emergency Medical Services for Children (EMSC) Targeted Issues grant program, Grant No. H34MC26201 for $900,000. This information or content and conclusions are those of the author and should not be construed as the official position or policy of, nor should any endorsements be inferred by HRSA, HHS or the U.S. Government.

CHaMP's Emergency Medical Services Affiliates:

  • , Milwaukee, WI
  • , Charlotte, NC
  • , Houston, TX
all
Overview

Emergency Medical Services (EMS) is a relatively young medical specialty, with a history that is less than 50 years old. Limited research has been conducted to determine how to optimize medical care in the prehospital setting, and the research that has been conducted has primarily utilized adult populations. Thus, a large knowledge gap exists in pediatric EMS, making research on children in a prehospital setting essential.

Charlotte, Houston, and Milwaukee Prehospital (CHaMP) is a node of the Pediatric Emergency Care Applied Research Network (PECARN) composed of three diverse Emergency Medical Services (EMS) agencies that collectively respond to nearly 350,000 EMS calls per year, of which approximately 25,000 are pediatric. The node is overseen by the ʼһ. Each EMS affiliate has a robust history of conducting successful EMS research (including randomized clinical trials) and has cultivated a culture among its providers that values research. From the administration to the field providers at each of these organizations, research is recognized as integral to their mission, and they value contributing to the EMS knowledge base.

Each EMS agency in CHaMP has formed partnerships with their receiving hospitals that allow them to provide state-of-the-art care as well as collect outcomes data for research. Emergency care requires a continuum of care that starts in the prehospital setting and continues through emergency department care and, if necessary, hospital admission. Research on emergency conditions requires cooperation across that continuum. Participating EMS agencies have strong partnerships with their receiving hospitals and have engaged them to support the CHaMP network. Therefore, the infrastructure developed by this collaboration is capable of successfully conducting pediatric-focused prehospital research that will improve prehospital care for ill and injured children on a national scale.

Populations served by EMS CHaMP Agencies

Total
Population served 3,966,514
Population under 21 1,184,471 (30%)
Square miles 1,365
Annual EMS calls 348,148
Annual Pediatric calls 25,201 (7%)
Highest level of care ALS
Number of Paramedics

1,034

Emergency Medical Services for Children Targeted Issue Webinar

The EMSC hosted a webinar, “EMS Research: A Path to Improving Pediatric Prehospital Care,” which featured the CHaMP node as an example of an EMSC-funded Targeted Issues project. The webinar was attended by more than 50 EMS individuals around the country. Nodal PI E. Brooke Lerner outlined CHaMP’s mission, infrastructure, role within the PECARN network, leadership in spearheading an EMS Consortium within PECARN, and the node’s research efforts. The presentation also provided listeners with the knowledge of how to develop a concept or protocol and move it through the PECARN process to increase the likelihood of funding.

Policies
Development and Approval of Research Concepts and Protocols (PDF)

This policy provides guidance for CHaMP investigators and others involved in PECARN research regarding the development, submission and approval process of a research concept and a research protocol for the CHaMP node.
Publications

Peer-Reviewed Published Journal Articles

  1. Browne LR, Shah MI, Studnek JR, Ostermayer DG, Reynolds S, Guse CE, Brousseau DC, Lerner EB: . Prehospital Emergency Care; 20(6): 759-767; Nov 2016.
  2. Reynolds SL, Studnek JR, Bryant K, VanderHave K, Grossman E, Moore CG, Young J, Hogg M, Runyon MS: BMJ Open, 6: 1-7; Sept 2016.
  3. Browne LR, Shah MI, Studnek JR, Farrell BM, Mattrisch, LM, Reynolds S, Ostermayer DG, Brousseau DC, Lerner EB: Prehospital Emergency Care, 20(3): 311-316; Jun 2016.
  4. Browne LR, Drayna PC, Studnek JR, Shah MI, Brousseau DC, Guse CE, Lerner EB: . Prehospital Emergency Care; 20(1): 59-65; Jan 2016.
  5. Drayna PC, Browne LR, Guse CE, Brousseau DC, Lerner EB: . Prehospital Emergency Care; 19(3): 441-447; Feb 2015.

Peer-Reviewed Published Abstracts

  1. Lerner EB, Studnek J, Brousseau D, Cushman JT, Dayan P, Drendel AL, Gray M, Kahn C, Meyer MT, Shah MN, Stanley R: A Consensus-Based Criterion Standard for Identification of Pediatric Patients Who Need Emergency Medical Services Transport to a Hospital With Higher Level Pediatric Care (PDF). Academic Emergency Medicine; 25(S1): S178; May 2018.
  2. Carey JM, Studnek JR, Browne LR, Leirmoe M, Ostermayer DG, Miller TC, Alqusairi D, Grawey T, Schroter S, Lerner EB, Shah MI: . Prehospital Emergency Care; 22(1): 107; Jan 2018.
  3. Arapi I, Lerner EB, Logan BR, Guse C, Browne L, Studnek J, Brousseau DC: . Prehospital Emergency Care; 21(1): 134-135; Jan 2017
  4. Drayna PC, Lerner EB, Browne L, Guse CE, Brousseau DC: . Prehospital Emergency Care; 19(1): 149; Jan 2015.
    Presented by Patrick Drayna at the National Association of EMS Physicians 2015 Annual Meeting, New Orleans, LA, Jan 2015.

National Unpublished Peer Reviewed Presentations

  1. Browne LR, Studnek JR, Shah MI, Brousseau DC, Guse CE, Lerner EB: The Current Status of Prehospital Pain Treatment in Children – Improvements are Still Needed.
    Presented by Lorin Browne at the Pediatric Academic Societies Annual Meeting, San Diego, CA, Apr 2015.
Structure

CHaMP Structure

The EMS Research Node Center (E-RNC) is CHaMP’s administrative hub and is housed at the ʼһ. The Houston Fire Department, Milwaukee EMS, and Mecklenburg EMS are CHaMP’s three EMS Affiliates. Each EMS affiliate has a site Principal Investigator who oversees the site's involvement in CHaMP. There is also an Academic Advisor at each site who will support the site's Principal Investigator who will conduct pediatric prehospital-based research.

Mecklenburg EMS (Medic)
Mecklenburg EMS (Medic) is a leader in clinical outcomes in the prehospital setting and provides a unique opportunity to conduct outcomes based research from initial patient contact to final hospital disposition. Medic is a municipal agency overseen by a Board of Commissioners comprised of representatives from both local healthcare systems and the County. Medic is an all Advanced Life Support level EMS agency with at least one paramedic responding on all ambulances dispatched to a medical emergency. Medic is dispatched to all medical emergencies within the County using a priority dispatch system to triage calls for severity. On a majority of medical calls first responders are simultaneously dispatched with first response provided by the city fire department or one of 19 county first response agencies. First response units are typically made up of between two and four Emergency Medical Technician-Basic trained automated external defibrillator equipped personnel responding on a fire engine or rescue unit. All medical providers within the EMS system follow the same protocols and provide care under the same medical director. Protocols at the Basic Life Support level form the base of all care protocols with only Medic paramedics permitted to perform care at the Advance Life Support level. Online and offline medical direction is provided by the EMS medical director and assistant medical director, or any emergency physician at a local receiving hospital. Protocol development, education, and clinical oversight are directed by the agency’s Quality Management Committee which is a sub-committee of the agency’s Medical Control Board. The Medical Control Board is comprised of local physicians with experience in emergency medicine, EMS, trauma, surgery, cardiovascular disease, and orthopedics. These physicians hold a variety of local, state, and national EMS leadership roles.

Medic emergently treats over 87,000 people per year, 15% of which are under the age of 21. Medic transports patients to nine affiliated paramedic-receiving hospitals which are operated by the two healthcare systems within the county. Both healthcare systems participate in the Medic Research Committee which receives its direction from the Quality Management Committee and is comprised of physician and non-physician researchers interested in outcomes based prehospital research. Medic has a Medical Services Division which is comprised of six full-time educators, who are all paramedics and former field training officers who provide essential training and educational support for any out-of-hospital clinical research protocols. Medic also contracts with the Center for Prehospital Medicine at Carolinas Medical Center to supplement education as needed. The quality improvement department at Medic consists of six individuals who provide data analysis support for ongoing research initiatives and conduct initial review and development of potential research projects. Engaged physicians from the agency medical control board, consistent medical direction, and a robust quality management system support the high quality out-of-hospital care that is provided in the county and also ensures consistent implementation of out-of-hospital clinical trials.

Medic uses an electronic patient care reporting and data collection system. Medic works closely with both healthcare systems in the county which includes the academic institution, Carolinas Medical Center. The EMS Medical Director for the County has an academic appointment at Carolinas Medical Center, works clinically in the emergency department, and has a strong track record of supporting and guiding EMS research. Medic has partnered with the Carolinas Medical Center and Novant Healthcare to conduct numerous research projects.

Houston Fire Department
The City of Houston’s EMS system is composed of a single Fire Department. The Houston Fire Department provides a two-tiered EMS system made up of over 3,500 providers, all of which are trained as firefighters and have at least Basic Life Support (BLS) training with an EMT-Basic certification. Nearly 15% of the firefighters are trained to provide Advanced Life Support with paramedic certification. Oversight of daily operations lies with the Assistant Fire Chief over EMS. All 911 calls for the City are directed to a single Public Safety Answering Point, the Houston Emergency Center, where civilian dispatchers and prehospital providers utilize computer aided dispatch protocols to triage calls, deliver care, and dispatch personnel. Prehospital providers follow agency-wide protocols to triage, evaluate, manage, and transport patients to over 40 area hospitals that include two level-one trauma centers and one free-standing tertiary pediatric hospital. Online and offline medical direction, protocol development, education and clinical oversight are provided by three full-time board certified emergency medicine physicians, all of whom are EMS fellowship-trained, and one part-time board certified pediatric emergency medicine physician. The Medical Director and Pediatric Medical Director both serve on local, state, and national EMS policy-making bodies including the Texas Governors EMS and Trauma Advisory Council and the National EMS Advisory Council. The State of Texas is one of 47 States that require that every paramedic pass the National Registry EMT Certification exam before practicing patient care.

The Houston Fire Department responds to over 220,000 calls per year resulting in approximately 170,000 transports. Approximately 14% of their patients are children. Forty percent of pediatric calls originate in the home, and 44% are injury related. The Houston Fire Department has a rich history of participating in research, including a 1985 study which was arguably one of the first major prehospital studies and identified a lack of benefit from anti-shock trousers. Since 1985 they have continued to conduct research including participating in randomized clinical trials evaluating a blood substitute for the treatment of trauma and a mechanical chest compression device for the treatment of out-of hospital cardiac arrest.

Milwaukee County EMS
The Milwaukee County EMS system provides a robust and established clinical laboratory, experienced in successfully completing numerous NIH-funded translational research protocols. The Milwaukee County EMS system is fire department based and provides Advanced Life Support (ALS) level services. It provides a tiered response with first response units composed of at least two Emergency Medical Technician-Basic trained, automated external defibrillator equipped personnel from either a privately owned ambulance or a municipal fire engine. Simultaneously, ALS ambulances are dispatched with the first response units. ALS ambulances are staffed by at least two paramedic level responders employed by one of the 12 municipal fire departments that service the region. All paramedics within the EMS system follow the same protocols and provide care under the same Medical Director. Online and offline medical direction, protocol development, education and clinical oversight are provided by a team of six board certified emergency medicine physicians. These physicians hold a variety of local, state, and national EMS leadership roles including serving as Wisconsin’s State Medical Director and Immediate Past President of the National Association of EMS Physicians.

The EMS system emergently treats over 40,000 people per year, 10% of which are under the age of 21 years. Milwaukee County EMS transports patients to 15 affiliated paramedic-receiving hospitals which participate in the Milwaukee Emergency Medicine Research Consortium, an experienced and proven research association that provides continued research interventions, monitoring, follow-up, and/or hospital medical record review for patients entered in out-of-hospital trials. Five, full-time educators, who are both paramedics and registered nurses, provide essential training and educational support for any out-of-hospital clinical research protocols. Physician online medical control and a well-tested quality management system support the high quality out-of-hospital care that is provided in the county and also ensure consistent implementation of out-of-hospital clinical trials. Although the system is made up of 12 distinct fire departments, each agency’s prehospital care providers participate in research as if they are from one agency. All 12 agencies allow a local research committee, composed of representatives from the various local stakeholders (including the public), to determine if a proposed research project should be implemented in the community.

Investigators

E Brooke Lerner

E. Brooke Lerner, PhD
The Principal Investigator for CHaMP is E. Brooke Lerner, PhD, tenured professor of Emergency Medicine and Pediatrics at the ʼһ. Dr. Lerner is an injury epidemiologist by training and a former EMS field provider who has dedicated her career to improving prehospital care through research. She has nearly 20 years of EMS related experience, has received several million dollars in federal funding for EMS research and has authored over 80 peer-reviewed publications. She is or has been on Boards for several national organizations including the National Association of EMS Physicians, Brain Trauma Foundation and the National Disaster Life support Foundation.

 

David Brousseau

David Brousseau, MD, MS
CHaMP’s PECARN Liaison and the academic advisor for the Milwaukee County EMS affiliate is David Brousseau, MD, MS. Dr. Brousseau has a Master’s degree in Epidemiology and serves as Section Chief of Pediatric Emergency Medicine, and the Director of the Physician Scientist Pathway at MCW. He has extensive experience leading federally-funded research. He also has a vast number of pediatric emergency medicine-related publications.

 

Brittany Farrell

Brittany Farrell, MS
Brittany Farrell, MS is the Nodal Administrator of CHaMP. Brittany graduated from the University of Wisconsin with an emphasis in public health and communication, and completed her MS in Communication from the University of Wisconsin-Whitewater. She serves as a Program Coordinator in the Department of Emergency Medicine at the ʼһ.

 

Manish Shah

Manish Shah, MD—EMSA Principal Investigator, Houston
Dr. Shah is Assistant Professor of Pediatrics and board-certified in Pediatric Emergency Medicine. Dr. Shah is the Director of Research Education for the Baylor College of Medicine, Department of Pediatrics, Section of Emergency Medicine, and he is nearing completion of a Master’s of Science in Clinical Research. As a pediatric prehospital advocate and researcher, he has directed the EMS for Children State Partnership in Texas since 2009 and is a prior recipient of an EMSC Targeted Issues grant to develop, implement, and measure outcomes after implementation of an evidence-based, standardized pediatric prehospital protocol for respiratory distress in three urban settings. As chair of the EMS subcommittee for the American Academy of Pediatrics Section of Emergency Medicine, Dr. Shah is a national leader and has contributed to revision of national pediatric prehospital performance measures and lectured at the National Association of EMS Physicians and EMS for Children Annual Meetings.

 

Lorin Browne

Lorin Browne, DO—EMSA Principal Investigator, Milwaukee
Dr. Browne serves as the Pediatric Medical Director for the Milwaukee County EMS system. He is also an Assistant Professor of Pediatrics in the Division of Emergency Medicine at the ʼһ, and is board-certified in both Pediatrics and Pediatric Emergency Medicine. Dr. Browne’s previous research endeavors include assessment of pediatric injuries resulting from motor vehicle crashes and use of computed tomography to identify pediatric cervical spine injuries.

 

Stacy Reynolds

Stacy Reynolds, MD—Charlotte EMSA Academic Advisor
Dr. Reynolds is Assistant Professor of Emergency Medicine in the Division of Pediatric Emergency Medicine, Department of Emergency Medicine at the Carolinas Medical Center, where she serves as the Pediatric Emergency Medicine Fellowship Director. She has completed several research studies and won two awards from the University of Pittsburgh for her research. She has extensive experience as an educator and mentor.

 

Jonathan R. Studnek, PhD, EMT-P—EMSA Principal Investigator, Charlotte
Dr. Studnek is an active provider and the Mecklenburg EMS Quality Improvement Manager in Charlotte, NC. He serves as the Director of Prehospital Research at the Carolinas Medical Center. Dr. Studnek has a doctorate in Epidemiology and completed his fellowship with the National Registry of EMTs, an organization that provides EMS certification and supports the state licensures process in 45 states. Prior to completing his doctoral degree, he was a paramedic in Albuquerque, NM, and was a research fellow at the National Registry of EMTs. He has authored over 30 peer-reviewed publications and completed two randomized controlled trials in the prehospital setting. Dr. Studnek has also served as the Director of Prehospital Research for the Center for Prehospital Medicine at Carolinas Medical Center and is currently Associate Graduate Faculty at the University of North Carolina-Charlotte.

Derrick Clay—Chair, Field Provider Advisory Committee, Houston, TX
Mr. Clay has been a firefighter with the Houston Fire Department for 15 years. In addition to providing care in the field, he has five years of EMS and orthopedic research experience. He was research coordinator for an industry-sponsored cardiac arrest study conducted by the Houston Fire Department, for which the Department enrolled nearly 3,000 individuals in cardiac arrest. Mr. Clay oversaw all aspects of the study including ensuring that the study procedures were logistically possible in Houston, all field providers were educated in and appropriately following the study procedures, that the site complied with all regulatory requirements, and that all required data was collected and accurate. Mr. Clay has continued to assist with the development and implementation of research trails within the Houston Fire Department.

Steven Vandeventer—Chair, Field Provider Advisory Committee, Charlotte, NC
Mr. Vandeventer is a paramedic with the Mecklenburg EMS Agency and serves as a quality and education specialist for the agency. He has served as the Research Coordinator for Mecklenburg EMS on two randomized controlled trials. Mr. Vandeventer oversaw all aspects of these studies, including ensuring that the study procedures were logistically possible in Charlotte, that all providers were educated in and were appropriately following the study procedures, that the site complied with all regulatory requirements, and that all required data was collected and accurate. He has continued to assist with the development and implementation of additional research within Mecklenburg EMS.

Kenneth Sternig—Chair, Field Provider Advisory Committee, Milwaukee, WI
Mr. Sternig is Program Director for Milwaukee County EMS. He works closely with local fire departments and hospital emergency departments in managing the EMS system’s infrastructure. Mr. Sternig has 20 years of EMS research experience; he has assisted the Resuscitation Outcomes Consortium and the Neurological Emergencies Treatment Trials Network in implementing numerous prehospital clinical trials in Milwaukee as well as assisting with local prospective and retrospective observational studies.

EMS Agencies
Mecklenburg EMS - Charlotte, NC
Mecklenburg County covers a 524 square mile region and is inclusive of the city of Charlotte, North Carolina. Mecklenburg County has a population of nearly 920,000 people of which 29% are under the age of 21. Medic is a municipal agency overseen by a Board of Commissioners comprised of representatives from two local healthcare systems and the County. The organization transports people to nine paramedic-receiving hospitals. Medic emergently treats over 87,000 people per year, 15% of which are under the age of 21.

Members, Mecklenburg Field Provider Advisory Committee
The members of the EMSA Field Provider Advisory Committee are all EMS providers, have an interest in EMS research and have previously participated in prehospital research. They have experience with all aspects of EMS study development including prehospital randomized clinical trials.

Houston EMS - Houston, TX
The City of Houston’s EMS system is composed of a single Fire Department that covers a 600 square mile region. The Houston Fire Department responds to over 220,000 calls per year resulting in approximately 170,000 transports. Approximately 14% of their patients are children. Forty percent of pediatric calls originate in the home, and 44% are injury related. The agency is a two-tiered fire-based system comprised of 3,500 providers, all trained as firefighters. The majority of city’s pediatric patients are transported to the University of Texas or Texas Children’s Hospital (an affiliate of the Baylor College of Medicine).

Members, Houston Field Provider Advisory Committee
The members of the EMSA Field Provider Advisory Committee are all EMS providers, have an interest in EMS research and have previously participated in prehospital research. They have experience with all aspects of EMS study development including prehospital randomized clinical trials.

Milwaukee County EMS - Milwaukee, WI
The Milwaukee County EMS serves an area composed of 19 municipalities, covering 241 square miles. The agency is made up of 12 municipal fire departments, who all share common protocols and provide care under the same medical director. The EMS system emergently treats over 40,000 people per year, 10% of which are under the age of 21 years. Milwaukee County EMS transports patients to 15 affiliated paramedic-receiving hospitals which participate in the Milwaukee Emergency Medicine Research Consortium, an experienced and proven research association that provides continued research interventions, monitoring, follow-up, and/or hospital medical record review for patients entered in out-of-hospital trials.

Members, Milwaukee Field Provider Advisory Committee
The members of the EMSA Field Provider Advisory Committee are all EMS providers, have an interest in EMS research and have previously participated in prehospital research. They have experience with all aspects of EMS study development including prehospital randomized clinical trials.
Research Education
The CHaMP Research Node of PECARN is pleased to offer resources and a complete lecture series to help guide potential investigators in developing and conducting prehospital research projects.

Pediatric EMS Federal Grant Workshop
The CHaMP Research Node held an EMS Grant Workshop in which investigators were able to meet with federal representatives to gain feedback on their ideas and learn about pathways to obtaining funding. The goal was to give researchers focused on pediatric EMS an understanding of the NIH process and insight on how to turn their concepts into federally funded research. See EMS Grant Workshop in question below.

This video examines how research in the EMS setting differs from hospital-based research. Viewers learn about the barriers to obtaining patient consent in the prehospital environment. Finally, the presentation summarizes the differences between a cohort study and a clinical trial and how they may affect the interpretation of the findings.

This presentation examines the origin of research ideas and provides a step-by-by step tutorial to develop a high-quality research question. Topics covered include what makes a good research question, identifying a suitable research question’s key components, and the construction of a research question using the PICO method.

This presentation looks at the various types of study designs and the importance of selecting the best design as it relates to time, feasibility, ethics, and producing good results. Viewers learn how to develop a practical and feasible protocol and methods for assessing their project to determine the most viable study design.

This presentation discusses human subject protections and examines ethical challenges in EMS research. Topics covered include how to conduct EMS-related studies and a review of the Emergency Exception from Informed Consent regulations.

This video demonstrates the search process, starting with finding keywords and ending with executing the search and accessing the literature. Topics covered include advanced searching techniques, using filters in PubMed, and accessing literature through open access websites like PubMed Central.

This video explores why literature appraisal is essential to study design and knowledge translation. Topics covered include identifying appropriate appraisal tools to critique different forms of medical literature, and the methodology for literature appraisal to develop evidence-based guidelines.

This video provides an overview on how to evaluate the role of random error within epidemiological studies. Viewers will learn about a measure of association of a sample and how to measure it, as well as how to make statistical inferences within an epidemiological study. Topics covered include hypothesis testing, P values, and quantifying sampling variability through confidence intervals.

This video examines why dissemination of findings is important, as well as describing ways to disseminate research results. Viewers learn where to submit their work and explore key elements of a scientific presentation or publication.

This video examines the importance of translational research as it relates to a bi-directional process of bench to bedside as well as bedside to bench research. Topics covered include an overview of how basic research knowledge turns into new and improved methods of preventing, diagnosing, and treating disease. The video also highlights the importance of how patient care insights are transferred into hypotheses that are tested and validated in a research process.

Additional lectures are currently in development. If you want to be notified when new lectures are available, please like us on our or check back at this site.

EMS Grant Workshop
The CHaMP Research Node held an EMS Grant Workshop in which investigators were able to meet with federal representatives to gain feedback on their ideas and learn about pathways to obtaining funding. The goal was to give researchers focused on pediatric EMS an understanding of the NIH process and insight on how to turn their concepts into federally funded research. Below is a list of the lectures that were provided and their key messages, along with links to available lecture slides.

View a list of federal funding resources (DOCX)

Is your idea ready for the NIH?
George Sopko, MD, MPH - Medical Officer and Program Director, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute
Key Points

Reviewers look at the funding proposal to see if there is a proven track record of infrastructure and evidence of success amongst collaborators. You should also address any issues in your proposal so reviewers don’t have an opportunity to expose weaknesses. Never think the reviewers will not notice something missing in a proposal – talk about it and address it with rational reasoning. Argue vigorously for what you are doing, the reviewers may not like it, but it’s better than having them guess what you are doing. Reviewers guessing what you are doing can also lead to a lack of consistency in the review from one submission to the next.

The NIH wants to fund a strong study design and an intervention that will directly impact patient outcomes. Determine the public health impact, gap or lack of evidence in medical practices, and how your study advances the field. Tell reviewers what is unique about your study and how it advances the field. Have a colleague who is not involved (preferably ‘your worst enemy’) read your proposal and criticize it; this will provide more valuable feedback than seeking validation from those who have “bought into” the project. The proposal needs to address design, population, outcomes, ethics/feasibility, and training. Work out all the details (e.g., FDA approval) before you submit for funding. Further, a pilot study is needed to have a competitive proposal.

How does the NIH Work? (PPTX)
Jane Scott, ScD, MSN, FAHA - Director, Office of Research Training and Career Development, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute
Key Points

The NIH is part of the U.S. Department of Health and Human Services (HHS) and is comprised of 27 institutes and centers. Over 90% of the NIH’s budget is distributed through extramural funding for research to colleges, universities, and medical centers. NHLBI (National Heart, Lung, and Blood Institute) is the third largest NIH Institute.

A PA is a Program Announcement and requests applications for funding in a generic area of research and is reviewed by a study section. An FOA is a Funding Opportunity Announcement; it is related to a special healthcare need and reviewed by a Special Emphasis Panel convened for the FOA. Federal funders are looking for high caliber projects that are unique. Talk to a Program Officer about your ideas to gain insight and direction for your application, and to discuss next steps for your application if it is not funded. Specifically ask your program officer if there is “anything special they can suggest that you can address in your proposal.”

Find out what the NIH institute funds and the angle you need to take to be competitive. Keep review criteria listed in the PA or FOA in mind as you write your grant application so that your proposal remains focused. Check the ‘Other Information’ section of the funding announcement for institute-specific information vital to your application. The is a search engine for every NIH-funded grant since 2004 that allows an investigator to determine if his/her idea is competitive and position their proposal to demonstrate what sets it apart from other funded work. It also allows investigators to determine which institute funded specific projects to determine if their idea fits a specific institute. Think broadly about the institute you’d like to target – you never know who might fund a new idea. Pay attention to the politics of funding and what areas of research are currently being funded.

Plan to invest six months into writing an R01. Meet with your local Grants and Contracts Office early to review the funding opportunity and internal processes for submission. Program Officers can talk with an investigator any time prior to submission about the proposal and after the grant review is complete to discuss comments or next steps. They cannot talk to an investigator while a grant is under review. Prior to submission, discuss possibility of the project officer sitting in on meeting to listen to reviewers discuss your application. After the grant review, discuss nature of review, comments, and where to go from there.

Make sure the grant’s budget matches the scope of work in the proposal/budget justification. The grant cover letter should clearly indicate your choice of institute and review panel (ask, don’t tell). Remember grant reviewers don’t see cover letter; only viewed by people assigning the application to a review (so keep them short and direct). Roughly 50% of grant applications are triaged during the review process due to a lack of resources for reviewing.

When and How to Talk to Project Officers, Part I
Robert Tamburro, MD, MSc - Medical Officer, Pediatric Trauma and Critical Illness Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development
Key Points

Funding announcements are too competitive to lose focus when writing your proposal – make sure you aren’t including unnecessary information. Check the to see what has already been funded and make sure to thoroughly read the RFA. Contact your Program Officer and make sure the funding opportunity is aligned with your interest. When you want to talk to your Program Officer, first send an email and ask for a time to talk. Include a brief introduction of yourself and project, attach a specific aims page, and ask if he/she would have any time to talk. If you have contacted a Program Officer about your project be sure to follow-up with them to let them know if/when you submit so they can consider going to the section’s review of your proposal. Once you have the summary statement, draft your response to the criticisms before setting up a call with your Program Officer then you can better discuss the next steps (resubmission, pursuing another funding source, etc.). Finally, remember the Approach section is the portion of the grant that can bring scores down the most.

When and How to Talk to Project Officers, Part II (PPTX)
Li-Shin Huang, PhD - Program Director, Office of Research Training and Career Development, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute
Key Points

The Matchmaker function in gives you the ability to upload text so you can search for awards based on your own abstracts or other documents that you have already written. For an R01, an institute and study section is needed – you can pick the study section you’d like to suggest by using Matchmaker and seeing the sections that exist. When writing your proposal, make sure the title matches key words for the institute you want assigned to your application. It’s important to remember that the Program Officer cannot assist in the period after your grant is submitted up until you receive your review. However, during this time, you can contact the Scientific Review Officer (SRO) with questions. Your grant will undergo either a general review by the Center for Scientific Review or a Special Emphasis Panel utilized by an NIH Institute.

For K awards, the Career Development/Career Goals and Objectives section is as important as the Research Plan. K awards are not given to proposals with sound science but weak career development plans.

Read funding announcements thoroughly and be alert for new/updated forms. Read the Request for Funding Application (RFA), which is specific to the NIH Institute to which you are applying. You should also read the Parent Announcement, which is designed for multiple participating institutes. Read the Special Note on the Parent Announcement to make sure you are following the institute where you are sending the grant’s specific instructions as you prepare your application. Finally, know the Rigor and Reproducibility requirements for your funding announcement. When writing application, put all sections of the Rigor and Reproducibility requirements into your grant application and state ‘N/A’ for sections that do not apply.

Career Development Award Options (PPTX)
Jane Scott, ScD, MSN, FAHA - Director, Office of Research Training and Career Development, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute
Key Points

When writing a career development award determine what interests you, and who in your field has experience and NIH funding. Talk with colleagues/faculty and find local resources (i.e., who is already funded with a K or R grant). Make sure that your research mentors fit you and your program. When developing your list of mentors, include at least one clinical mentor for a clinical research project.

Post-doctoral individuals should apply for T32 grants; this award provides 2-3 years research training and is a focused research program. The award is suitable for an investigator who needs more training to get to an independent award and involves a 90% time commitment. Late postdoc or early faculty should apply for Institutional K Awards (KL2, K12); these awards provide 2-3 years continued training and involve a 75% time commitment. Early faculty should apply for Individual K Awards, which provide 3-5 years research training. To be successful, you need an investigator, mentoring team, institutional support, proposed research, and a career development plan. During this time, an investigator can apply for R grants. A K23 is ideal for clinicians; they require a hands-on activity with patients. A K08 is ideal for physicians who work with large data sets. A K99/R00 is for individuals who are two years postdoc and transitioning to faculty; this award involves three years of independent research. The NIH also offers a K01 Diversity Supplement; if you have an R01, you can apply for this supplement. The mentee can be at any level (e.g., college, PhD, early faculty, etc.).

It is important to remember that the NIH may not have the type of funding that you want – there may be other organizations with funding opportunities that better suit your research interests. Regardless of where you apply, be compelling in what you are doing and convince the reviewers why your grant deserves funding.

Pilot Studies and Pilot Funding (PPT)
E. Brooke Lerner, PhD - Professor and Research Director, Department of Emergency Medicine, Nodal Principal Investigator, CHaMP Node of PECARN, MCW
Key Points

Find your own passion and pursue every opportunity available. If you truly care about the research question or problem, invest effort. Keep your ears open for opportunities and be ready to make an attempt, even if you are not confident the opportunity will be successful. Build a network of like interested and minded collaborators that can assist you when pursuing funding. Learn from rejection and move on to the next opportunity. Know your local funding sources and apply for them (CTSI, Institution Funds, Foundations, Non-Federal Specialty Organizations). If you have an opportunity, take it (even if it isn’t NIH-related). Consider working with students/learners and learner funding (e.g., local or EMRA) to get parts of projects achieved. Taking these steps will help you accomplish pilot studies and build the foundation for applying for larger funding opportunities.

Emergency Medicine/EMS Research at the NIH (PPTX)
Jeremy Brown, MD - Director, Office of Emergency Care Research, National Institute of General Medical Sciences
Key Points

The NIH funds a wide range of research relevant to Emergency Medicine, with opportunities in both training and independent areas. It is critical to think about the mission of the institute to which you apply. Think about the population your project affects and which institute owns that population – that is the institute to target for funding applications. A helpful tool is the Research Condition and Disease Categorization (RCDC), which lists the amount of NIH spending and funded projects in various areas. Note: a New Investigator is anyone without R01 funding. In contrast, an Early Investigator is anyone within 10 years of a terminal degree.

NICHD Overview
Robert Tamburro, MD, MSc - Medical Officer, Pediatric Trauma and Critical Illness Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development
Key Points

When writing a cover letter, make sure you align with the institute mission to which you are applying. Examples of possible funding opportunities within the NICHD include an R03, which is a small, two-year secondary analysis that focuses on data harmonization and does not need pilot data. An R21 is a two-year exploratory grant with a maximum budget of $275,000. The UH1 and UH3 is a dual application for prior work and a clinical trial. Investigators should leverage anything possible and pursue any avenue that offers funding in order to conduct pilot research and build a foundation of evidence for your research question. If you have no preliminary data, your R01 application will be triaged.

NHLBI and SIREN Overview (PPTX)
George Sopko, MD, MPH - Medical Officer and Program Director, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute
Key Points

When initiating a project with SIREN the Principal Investigator brings a proposal to the SIREN executive committee for full discussion; the committee then determines if the proposal is suitable for the SIREN network. The committee only meets to review proposals three times a year, so investigators must carefully create a timeline for pursuing funding. If SIREN-approves, then the PI applies for funding (through either NHLBI or NINDS) for their clinical trial through the usual funding mechanism, depending on the area of study. If the proposed budget is over $500,000 for any NIH application, an investigator needs permission from the NIH “to exceed the cap” prior to submission (most network grants will exceed the cap). If you are bringing an idea to the NIH to work with SIREN, Jeremy Brown of NIGMS is the first contact (jeremy.brown@nih.gov). As of now, SIREN focuses on adult studies. If you are looking to do a pediatric study and use SIREN, you would need to make a compelling case about why you need SIREN’s resources to conduct your study.

Working with Your CTSA (PPTX)
Cynthia Morris, PhD, MPH - Vice Chair of Medical Informatics & Clinical Epidemiology
Professor of Medicine, Public Health, and Preventative Medicine, Oregon Health & Science University
Key Points

There are 60 CTSA sites located across the country, so it is likely one of these sites is housed at your institution. Investigators should get to know their institutional CTSA. Often, the CTSA at an institution will have a small pool of funding that can be used to help get a K or an R award. This local resource is often overlooked, so you likely have a good chance to secure funds, which can then be used to move forward with pilot work and speed up the process of applying for larger grants. CTSAs have space for clinical research, along with a lot of regulatory knowledge.
Connections and Support

(HRSA)

The Health Resources and Services Administration (HRSA) was created in 1982 through the merger of prior agencies with a goal of improving health and making care services increasingly accessible to the public. The organization works to strengthen the health workforce and communities, thus improving overall health equity.

Emergency Medical Services for Children

The Emergency Medical Services for Children program is a national initiative aimed at reducing disability or death in children due to illness and injury by examining prevention and making sure children receive the highest level of emergency medical care. EMSC’s purpose is to ensure that state-of-the-art EMS are available for ill or injured children and adolescents, pediatric services are part of an EMS system with the best possible resources, and that a complete spectrum of emergency services (e.g. primary prevention of illness and injury, acute care, and rehabilitation) is provided to all children and adolescents. The program is administered by the Health Services Research Administration (HRSA) Maternal and Child Health Bureau (MCHB).

(PECARN)

PECARN is the Pediatric Emergency Care Applied Research Network, the first federally funded multi-institutional network for research in pediatric emergency medicine in the United States. PECARN’s goal is to conduct scrupulous research while examining the prevention and management of illnesses and injuries in youth seeking emergency medicine services.

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