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June 21, 2017 GE/EMF POC Challenge RFP 1
GE/EMF POINT OF CARE CHALLENGE
1. GE HEALTHCARE & EMF BACKGROUND AND OVERVIEW
1.1. Collaboration Overview:
In June 2017, GE Healthcare (GEHC) and the Emergency Medicine Foundation (EMF)
launched the GE/EMF POINT OF CARE CHALLENGE (GE/EMF POC Challenge). This
strategic partnership between GE Healthcare and EMF (the research arm of the American
College of Emergency Physicians: ACEP) was created to organize yearly worldwide
competitions aimed at engaging clinical researchers with demonstrated excellence in
emergency and critical care medicine and related disciplines.
With $500,000, in cash and equipment value, GE/EMF POC Challenge is a first of its kind
competition - exclusively focused on the practice of medicine at the point of care. Our goal is
to inspire emergency and critical care clinicians, researchers, entrepreneurs and innovators
from around the world to develop leading-edge solutions for difficult clinical challenges.
GE Healthcare will provide funding for research that supports the mission of the challenge.
1.2. Collaboration Mission:
Our mission is to support research that addresses high-priority clinical questions regarding the
diagnosis and treatment of clinical conditions at the point of care (especially in emergency and
critical care settings). We want to support research that utilizes ultrasound and ventilation
technologies, as well as other innovations and techniques – in any combination, or as individual
applications.
1.3. Collaboration Call For Proposals:
The GE/EMF POC Challenge aims to have yearly iterations - designated as editions. Each will
include a Call for Proposals (RFP) to be collaboratively released by GE Healthcare & EMF.
Each RFP will be strategically focused on specific challenges and/or aspects of Point-of-Care
medical care.
2. GE HEALTHCARE & EMF PROGRAM GOVERNANCE
June 21, 2017 GE/EMF POC Challenge RFP 2
This RFP is jointly managed under the governance of GE Healthcare & EMF. The RFP process
will be managed by GE Healthcare and the review and award process will be managed by the
American College of Emergency Physicians’ Scientific Review Subcommittee.
The subsequent research grant will be governed by an independent research agreement
between GE Healthcare and grantees.
3. 2017 GE/EMF POC Challenge CALL FOR PROPOSALS
The 2017 inaugural edition of the GE/EMF POC Challenge specifically invites proposals to improve
the care of patients that are possibly approaching or experiencing, either or both:
1. SHOCK
2. NEED FOR MECHANICAL VENTILATION
Proposals need to apply one or more of the following:
a. Innovative applications of ultrasound imaging in the care of patients in Shock (and/or Trauma).
b. New developments in the use of ventilator technology (such as respiratory devices in the
ICU, for example).
Proposals should be prospective trials, evaluating hypotheses of improved diagnosis or
intervention or have an impact on the emergency and critical care continuum.
3.1. Overview:
Why Shock?
Shock, in its many forms is one of the leading causes of death around the world.
Every year, more than a million Americans present or develop shock and more than 19% of US
Healthcare costs are associated with this condition1. Patients undergoing shock suffer poor health
outcomes. At the same time, providers treating for this condition report significant economic
challenges and protracted ICU stays and hospital readmissions for their patients.
Despite improved understanding of its pathophysiology and significant advances in technology,
shock remains a serious problem with high morbidity and mortality rates. Early treatment is
essential, but is hampered by the fact that the signs and symptoms of shock appear only after
1. Rivers E. Approach to the patient with shock. In: Goldman L, Schafer L, eds. Cecil Medicine. 24th ed.
Philadelphia, Pa: Saunders Elsevier; 2011: Chap 106
June 21, 2017 GE/EMF POC Challenge RFP 3
shock is fully established, or even advanced – and typically after the body’s compensatory
mechanisms have begun to fail.
Why Ultrasound?
Over the past two decades, point-of-care ultrasound has evolved in the emergency department
from the occasional use of the RUSH (Rapid Ultrasound for Shock and Hypotension) or FAST
(Focused Assessment with Sonography) exam in trauma, to a standard part of the clinical protocol
(demonstrated by mandated curriculum for residency training).
We hypothesize that the diagnosis, treatment, and follow-up of shock using ultrasound in
Emergency and Critical Care medicine is ripe for disruption. Point of care ultrasound (POCUS)
performed by emergency and critical care physicians or mid-level practitioners can be used to
diagnose undifferentiated shock earlier, faster, and with much more accuracy. This should improve
patient outcomes, reduce costs, and limit the necessity for more expensive and potentially harmful
follow-up treatment pathways.
This competitive Challenge addresses patient-centric treatments and seeks to revolutionize the
clinical space by incentivizing innovation in a field that has seen only minimal innovation in the
past.
Why Mechanical Ventilation?
Although mechanical ventilation is life-saving technology, it can have unintended consequences
such as ventilator-induced lung injury and ventilator acquired pneumonia. An estimated 19.3% of
mechanically ventilated ICU patients develop acute respiratory distress syndrome (ARDS).
Patients with ARDS developed more complications and their hospital mortality (49.5%) is double
that of patients without.2 Lung protective ventilation strategies employed by physicians can reduce
acute lung injury and the onset of ARDS.
We hypothesize that Functional Residual Capacity (FRC) measurements can be used by critical
care physicians to determine optimal ventilator settings to balance volume and pressure at the
2 “Outcome of acute respiratory distress syndrome in university and non-university hospitals in Germany”
Raymondos et al. Critical Care (2017) 21:122 DOI 10.1186/s13054-017-1687-0
June 21, 2017 GE/EMF POC Challenge RFP 4
alveolar level. Optimal ventilator settings that lead to improved lung recruitment and fewer adverse
events will result in shorter time on the ventilator and in the ICU.
Additionally, we anticipate that research will show routine use of bedside lung ultrasound provides
an effective therapy feedback loop. Also, monitoring lung recruitment with ultrasound will reduce
the radiation exposure for clinicians and patients compared to chest x-rays.3
3.2. Questions to be addressed in this RFP:
This RFP solicits research studies that will improve understanding of diagnosis, treatment,
recovery and prevention, related to shock and mechanical ventilation. Some examples of high level
objectives are detailed below.
Research Objective: Research that leads to advancements in imaging or application
development to improve diagnosis, treatment, recovery and prevention - related to shock and
mechanical ventilation. Research that develops clinical strategies to prevent and manage shock
and mechanical ventilation.
Potential areas of focus include, but are not limited to, the following:
Ultrasound imaging to improve the diagnosis of shock, help distinguish/differentiate the
etiology(s) of the patient’s shock, and/or add insight to the physiological understanding of
shock
Ultrasound imaging techniques to improve patient management, clinical decision making
and/or outcomes
Ultrasound imaging techniques and technologies to drive cost effective patient
management. Consideration should be made to specifically look at the overall cost of the
patient’s clinical management.
Ultrasound imaging to improve understanding of risk factors and prognostic markers for
shock and/or the need for mechanical ventilation
Ultrasound imaging techniques to help guide clinical decision making with consideration of
reducing pulmonary injury and/or complications from mechanical ventilation
3 “Clinical review: Bedside lung ultrasound in critical care practice”
Bélaïd Bouhemad, Mao Zhang, Qin Lu and Jean-Jacques Rouby Critical Care (2007) 11:205 DOI: 10.1186/cc5668 Published: 16 February 2007
June 21, 2017 GE/EMF POC Challenge RFP 5
4. AWARD MECHANISMS AND AMOUNTS
4.1. Overview:
Deadline for receipt of application August 31, 2017
Notification of award September 30, 2017
Funding Period Nov 1, 2017 – Oct 31, 2018
Number of grants 4
Funding Amount $50,000
Research Duration 1 year
Research Location Domestic and International
1) Four grants will be selected to receive awards by the ACEP Scientific Research
Subcommittee. Each will receive a grant of $50,000.
2) One of the awardees will receive an additional $150,000 grant. The award of this grant will
be determined by open voting of all current members of ACEP.
3) All grantees will have the option to use a GE Healthcare ultrasound system and/or
ventilation system or equivalent as required for the duration of their research.
4.2. Duration of Funded Research Projects:
The proposed research projects should not exceed one (1) year in duration.
4.3. Overhead and Indirect Cost Limits:
Any proposal in which the budget exceeds the maximum amount in total costs (direct and indirect)
will not be considered.
4.4. Acceptable Use and Limitations of the Awarded Support:
The awarded funds can be used to support the proposed research including:
Salaries of investigators
The cost of medical procedures that are required for the research endpoints and not part
of standard of care
Research-related subject costs including clinical supplies
Consumables
June 21, 2017 GE/EMF POC Challenge RFP 6
Necessary consortium expenses including costs of travel and communication between
collaborating sites
Unallowable expenses that cannot be included in the budget are:
Costs of travel to conferences or for educational meetings
Capital equipment purchases
The total projected costs, including the direct and indirect costs of any subcontract or consortium
costs, must be included in the total direct costs.
Applications must include a comprehensive budget with details provided for the project, including
all direct and indirect costs. The projected funding requirements for the entire research project
must be included.
ELIGIBILITY
The principal investigator will make all arrangements for conduct of the proposed research
projects, and assumes responsibility for conducting the research projects and supervising the work
of all associate investigators in accordance and compliance with applicable guidelines and
practices including Good Clinical Practice (GCP), federal and local regulations including HIPAA,
and IRB or IACUC oversight. The study must be registered on ClinicalTrials.gov; registration and
all required reporting is the responsibility of the principal investigator.
INSTITUTIONAL SUPPORT
The applicant is required to demonstrate that the project can be successfully completed at their
institution. The applicant must demonstrate that access to a suitable caseload, patient population
or database will be available for study during the funding period. Application for IRB approval
must be documented in the proposal. IRB approval is required prior to dispensation of
funds.
The applicant must also submit a letter from the Chair/Director of Emergency Medicine or
equivalent stating that adequate support and time will be available to the applicant to complete the
proposed project.
EVALUATION OF APPLICATIONS
Each application will be reviewed by emergency medicine physicians who are actively involved in
basic science and clinical research. Each application will be judged primarily on: (1) the
significance of the project to the use of ultrasound and/or ventilation in emergency medicine, (2)
the soundness of the research and analysis methodology, (3) the likelihood and ability of the
investigators and institution to successfully complete the project, and (4) innovation – how likely
the proposed research will lead to disruption in the current care of patients in Shock and/or
Mechanical Ventilation. The final funding decision for the four $50,000 grantees will be made by
June 21, 2017 GE/EMF POC Challenge RFP 7
the ACEP Scientific Review Subcommittee and the Emergency Medicine Foundation Board of
Trustees and all decisions are final.
ADDITIONAL FUNDING AVAILABLE
This funding opportunity is unique. There will be a maximum of four grant awards for up to $50,000.
Once selected, the four grantees will present their research project goals and design to the
emergency medicine community (live presentations during ACEP’s 2017 Scientific Assembly in
Washington DC - and online via EMF and GEHC communications) for the opportunity to be
selected to receive an additional $150,000 in grant funds to expand their research.
The $150,000 additional grant will be awarded to the winner of a social media voting event, which
is explained below in the “Social Media Contest” section.
The scope of work for each proposal should be limited to the $50,000 amount, but should include
an explanation of how the proposed research would become better or more effective, if the
additional funding is provided.
To further support the grantees, in addition to the above mentioned cash grants, GE Healthcare
will also be providing ultrasound and ventilator equipment up to a total value of $150,000.
TERMS OF THE AWARD
Research should be completed within one year of the Grant start date.
Grant funds will be disbursed, per the GEHC Investigator Sponsored Research (ISR) program
process - which stipulates that payments are tied to delivery of milestones.
Grant Awardees are required to register for and travel to ACEP17 in Washington DC as part of
their award acceptance. Grant funds cannot be used for this registration/travel requirement.
Limitations on Awards
Funds may be used for materials and supplies and to provide salary support. Capital equipment
expenditures (costing more than $5,000 and a life of over one year) are excluded from the budget.
Payments will be made to the principal investigator's institution that will be responsible for
administering the funds. Of the awarded funds, no more than 10% can be allocated for indirect
costs or institutional overhead, including cost of publications, or secretarial support. This overhead
is included in the grant amount provided and will not be an additional payment. Detailed audited
financial reports may be required. GEHC and EMF are not fiscally responsible for additional funds
necessary for the project's completion.
Change of Status of Principal Investigator
June 21, 2017 GE/EMF POC Challenge RFP 8
If the principal investigator changes affiliations or ceases research in the field for which the award
was made, the award will terminate and the remaining balance will be returned to GE Healthcare.
Liability of the Emergency Medicine Foundation and GE Healthcare
The EMF and GE Healthcare assume no financial liability if patient care responsibilities of any kind
are undertaken by the program faculty or investigator. The principal investigator and his or her
institution acknowledge that the EMF and GE Healthcare are not legally liable for the conduct of
the institution, the principal investigator, the program faculty, or any associate investigators.
Compliance
The applicant is responsible for ensuring that all aspects of the research are conducted in
accordance with Good Clinical Practice (GCP) guidelines, when applicable, in compliance with all
local and federal regulations, including HIPAA, and registration on ClinicalTrials.gov. Application
for Local Ethics Committee (e.g., Institutional Review Board [IRB] or Institutional Animal Care and
Use Committee [IACUC]) approval at the time of submission is required.
Number of Submissions
There is no limitation on the number of submissions that a given investigator or institution can
participate in or submit. Investigators are encouraged to submit applications for all research
projects that are responsive to the mission of the challenge as described in this RFP.
Intellectual Property and Confidentiality
All submissions remain the intellectual property of the individuals or organizations that developed
them.
GE Healthcare reserves the right to negotiate intellectual property terms as part of individual
research agreements only with final Grantees.
Submitted applications will be confidential; however, the technical and lay abstracts and statement
of relevance for funded applications may be released to the public. Unfunded applications will
remain confidential.
Grant recipients must to agree to provide General Electric access to de-identified image and
clinical data from the studies which result from the grants.
Grant recipients must collect data with adequate informed consent that would permit the use of
de-identified in further General Electric research or marketing activities.
June 21, 2017 GE/EMF POC Challenge RFP 9
Marketing
Grantees are required to submit self- or professionally-made videos and team photographs as part
of the submission process. Videos shall be accessible to the sponsors via a Vimeo or YouTube
link. Videos shall not be submitted as file attachments to their Entries. All Entries must be in
English. Photographs shall be submitted in JPEG, GIF or TIFF format, or as part of a PDF
attachment.
This video will describe their research objectives, their use of one, or any combination of the
following: ultrasound technologies, ventilator technologies, other monitoring technologies,
innovative techniques, methods or even strategies to improve patient care – as well as how their
research would be improved and expanded if they are granted an additional $150,000.
The team photographs and videos will be used by EMF and GE Healthcare to promote the
challenge as well as the research proposals.
Each of the four Grantees is required to attend the ACEP 2017 Scientific Assembly (Oct. 29 - Nov.
1, 2017 in Washington DC, USA). As part of promotional efforts, Grantees will be asked to present
their proposals to multiple audiences during the conference. Travel/registration costs to attend
ACEP17 for the Grantees cannot be covered as part of grant.
Social Media Contest
Each of the four Grantees is eligible for additional $150,000 in funding. One winner
selected based on the number of votes they receive in an online, Social Media contest
moderated on the EMF/GE Healthcare Challenge website.
The voting will be called for on the EMF/GE Healthcare website and will be promoted
across social communication channels.
Grantees and/or their respective institutions are also allowed to promote their research
proposals in social media.
Voting will be limited to worldwide membership of ACEP, Emergency Medicine
Residents’ Association (EMRA), and Society of Emergency Medicine Physician
Assistants (SEMPA).
GE Healthcare will aim to create “team profiles” of each of the Grantees, which might
include (but not limited to), taking video interviews of the Grantee teams, photographs
of potential research sites, blog submissions from Grantees or a combination of any of
the methods described above.
GE Healthcare reserves the right to not promote any or all of the Grantees.
June 21, 2017 GE/EMF POC Challenge RFP 10
The team profiles will be hosted on the Challenge website and may be used by EMF/GE
Healthcare or Grantees to promote each of the team’s proposals.
SUPPORT FACILITIES
The applicant must submit letters of support if the proposed project uses facilities not routinely
available to, or directly under the supervision of, the sponsoring program.
PUBLICATIONS
One of the primary goals of the GE/EMF POC Challenge is to encourage the communication of
results and discoveries. Grantees must submit an abstract to ACEP’s Scientific Assembly
Research Forum prior to presenting or publishing at any other forum. They are also strongly
encouraged to submit their results to Annals of Emergency Medicine. All discoveries resulting from
work supported in part by GE Healthcare and EMF should be made available to the public and
scientific community through scientific and/or public policy channels such as national meetings and
peer-reviewed publications. Publications will acknowledge the support of Emergency Medicine
Foundation and GE Healthcare. Two reprints of each publication should be forwarded to EMF and
GE Healthcare. The specific details concerning publication policy will be part of individual
agreements with successful applicants.
PROGRESS REPORTS AND MONEY MANAGEMENT
The principal investigator is required to submit a six-month progress report and a final progress
report within thirty days of the conclusion of the award year. Additional reports may be required.
Failure to provide such reports is strongly discouraged – and subject to corrective measures, per
GEHC Investigator Sponsored Research (ISR) program policies.
Furthermore, failure to provide interim and final reports may negatively impact your institution’s
ability to apply for future EMF/GEHC awards. EMF/GEHC will maintain the copyright of all such
reports. Progress reports must include an accounting report using Generally Accepted Accounting
Procedures showing the distribution of funds with a signature from an institutional official (e.g.,
accountant, grants manager, administrator from the Office of Sponsored Research).
SURVEYS
The principal investigator and the institution will be surveyed periodically following completion of
the award regarding subsequent grants/contracts obtained, and publications. The principal
investigator and the institution will be expected to respond to these surveys as GEHC and EMF
will rely on such information to support continuation of the award program.
June 21, 2017 GE/EMF POC Challenge RFP 11
RESEARCH FORUM
Grantees are required to present their research projects at ACEP’s 2017 Scientific Assembly,
during a Research Forum luncheon and specific section meetings. Grantees will be required to
submit their research findings to the Research Forum immediately following the completion of the
award year.
GRANTEE WORKSHOP
Grantees will be expected to attend a grantee workshop hosted by EMF that brings together
various grant recipients and invites them to present their progress and discuss challenges. Senior
researchers and faculty will be available to help solve problems, including staff management, life
balance, and institutional delays
RESEARCH AGREEMENT
Grant recipients are required to enter into a research agreement with GE Healthcare and will be
subject to GE Healthcare’s research policies and funding guidelines.
GE Healthcare reserves the right to cancel the grant if GEHC’s research policies or funding
guidelines are not followed or agreed upon by Grantees.
June 21, 2017 GE/EMF POC Challenge RFP 12
APPLICATION INSTRUCTIONS
Submission in electronic format is required. No paper copies please. Please complete your
grant application on the link on the Challenge website (www.gepocchallenge.com). Be
prepared to submit information about your project including the name and address of your
institution, detailed information about where the grant payments will be sent, and names and
affiliations of other key personnel. Once the “questionnaire” is completed, you will need to
press submit then you will be guided to the next page where you can upload your application
in a PDF format. INCOMPLETE PROPOSALS OR PROPOSALS RECEIVED AFTER THE
DEADLINE DATE INDICATED UNDER GENERAL INFORMATION WILL NOT BE
CONSIDERED.
Use English only and avoid jargon and unusual abbreviations. For terms not universally known,
spell out the term the first time it is used with the appropriate abbreviation in parentheses; the
abbreviation may be used thereafter.
Type the application, single-spaced, and stay within the margin limitations indicated on the
forms and continuation pages. The type must be clear and readily legible, no smaller than 15
characters per inch. (If in doubt, use 12 pt. size font.) Finally, there must be no more than six
lines of text within a vertical inch.
Use black type; do not use photo-reduction.
Do not submit an incomplete application. An application will be considered incomplete if it
is illegible, if it fails to follow instructions, or if the material presented is insufficient to
permit an adequate review.
Unless specifically required by these instructions (e.g. human subject certification) do not send
supplementary material.
Number the pages consecutively at the bottom throughout the application. Do not use suffixes
such as 5a, 5b. Type the name of the Principal Investigator at the top of each printed page. AN
APPLICATION WILL NOT BE CONSIDERED IF PAGE LIMITATIONS ARE NOT
OBSERVED.
If you have any questions, please contact: Cynthia Singh ([email protected]) and Ashutosh
Dhar ([email protected]).
The application consists of the following sections:
1. INFORMATION PAGE
Name the one person responsible to the applicant organization for the scientific and technical
direction of the project. Choose a title that is descriptive and specifically appropriate, rather
than general.
June 21, 2017 GE/EMF POC Challenge RFP 13
2. Technical ABSTRACT (limit 1 page)
Brief summary of research proposal, research hypothesis, specific aims, and significance.
3. Lay ABSTRACT (limit 1 page)
Summary of research proposal using language and terms familiar to the general public.
4. STATEMENT OF RELEVANCE (limit 1/2 page)
Brief statement explaining how the proposed research is responsive the mission of the
GE/EMF POC Challenge. How does the proposed study address high-priority clinical
questions regarding the prevention, diagnosis, treatment and follow-up of medical Shock using
ultrasound at the point-of-care and, or more effective usage of mechanical ventilators and if
successful, how will it improve patient care.
5. STATEMENT OF INNOVATION (limit 1/2 page)
Brief statement explaining how the proposed research utilizes ultrasound at the point of care
to challenge existing clinical paradigms or technologies in the diagnosis, treatment and follow-
up of medical Shock or improved/more effective usage of mechanical ventilators.
6. TABLE OF CONTENTS
7. RESEARCH PROPOSAL FOR THE $50,000 GRANT AWARD (limit 10 pages)
Please use the following subheadings:
Specific Aims
State concisely the goals of the proposed research and summarize the expected
outcome(s), including the impact that the results of the proposed research will exert on
the research field(s) involved.
List succinctly the specific objectives of the research proposed, e.g., to test a stated
hypothesis, create a novel design, solve a specific problem, challenge an existing
paradigm or clinical practice, address a critical barrier to progress in the field, or develop
new technology.
Include a statistically justified estimate of the sample size required to achieve the
primary aim.
Specific Aims are limited to one page.
June 21, 2017 GE/EMF POC Challenge RFP 14
Significance
Explain the impact of Shock on the health of individuals and populations
Explain how the potential for the study to improve healthcare and outcomes of patients
in Shock
Describe how the concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field will be changed if the proposed aims are
achieved.
Innovation
Explain any refinements, improvements, or new applications of theoretical concepts,
approaches or methodologies, instrumentation, or interventions.
Approach
Describe overall strategy, methodology, and analyses to be used to accomplish specific
aims of project.
Discuss potential problems, alternative strategies, and benchmarks for success
anticipated to achieve the aims.
If the project is in the early stages of development, describe any strategy to establish
feasibility, and address the management of any high-risk aspects of the proposed work.
Preliminary studies or data. Include information on preliminary studies or data. Discuss
the PD/PI’s preliminary studies, data, and or experience pertinent to this application.
Although not required, preliminary data can be an essential part of a research grant
application and help to establish the likelihood of success of the proposed project.
If the research plan utilizes the GEHC’s equipment or equivalent, clearly describe the
purpose and utilization of this device. Note the use of this device in the research project
is optional and is neither a requirement for this RFP nor a prerequisite to qualify as a
grantee
DESCRIPTION OF THE SUPPLEMENTAL $150,000 FUNDING RESEARCH PROJECT (limit
2 pages)
Describe the expanded research (increased enrollment, broadened patient base,
further analysis, etc.) to be completed if awarded an additional $150,000 in funding.
Describe how your proposal will be improved with an additional $150,000 funding.
June 21, 2017 GE/EMF POC Challenge RFP 15
Provide a maximum 2-minute-long video on the description of your research. Video
that shall be accessible to the sponsors via a Vimeo or YouTube link. Videos shall
not be submitted as file attachments to their Entries.
8. PERSONAL STATEMENT (limit 1 page)
The applicant should compose and submit a personal statement that addresses:
a. the applicant’s interest in the topic and this project
b. the applicant’s perception of his/her role in the project
c. any additional pertinent experience or interests the applicant wishes the committee to
consider
9. ROLE OF PARTICIPANTS (limit 1 page)
List the investigators and consultants. Include a brief description of how and to what extent
each will be involved in the proposed project.
10. BIOGRAPHICAL SKETCHES
Use the NIH Biographical Sketch Format Page available at
www.grants.nih.gov/grants/funding/phs398/phs398.html#
Information is requested for the applicant and any associate investigators who will be involved
with the project.
8. RESOURCES AND ENVIRONMENT
Describe the research facilities (laboratory space, clinical population, etc.) available. If
computer access or statistical support is available, it should be described in this section.
9. BUDGET
Use the NIH Form Detailed Budget for Initial Budget Period available at
www.grants.nih.gov/grants/funding/phs398/phs398.html#
Indicate how the money will be spent. Justify all major expenditures.
10. OTHER SUPPORT
List all current and pending intramural and extramural research funding for the applicant and
co-investigators. For each item indicate the grant identification number, grant type, PI, funding
source, annual direct costs, funding period, percent effort, grant title, and brief description of
June 21, 2017 GE/EMF POC Challenge RFP 16
project. For all items indicate whether there is any scientific or budgetary overlap with the
current proposal.
11. ETHICS
Human subjects. For all research involving human subjects, a part of the peer review process
will include careful consideration of protections from research risks, as well as the appropriate
inclusion of women, minorities, and children. The ACEP Scientific Review Subcommittee will
assess the adequacy of safeguards of the rights and welfare of research participants, and the
appropriate inclusion of women, minorities, and children, based on the information in the
application. This evaluation will be factored into the overall score. The information on the
protection of human subjects that you are required to provide in this section is identical to
information that you will be required to provide to an IRB at your own institution and are required
by most Federal agencies. This section must address the following items. These can be copied
and pasted directly into your application.
The applicant should include specific measures on how protected health information (as
defined by the Human Health Services) will be handled in accordance with the Privacy Rule of
the Health Insurance Portability Accountability Act (HIPAA).”
1. RISKS TO THE SUBJECTS
a. Human Subjects Involvement and Characteristics
Describe the proposed involvement of human subjects in the work outlined in the Research
Design and Methods section. Describe the characteristics of the subject population, including
their anticipated number, age range, and health status. Identify the criteria for inclusion or
exclusion of any subpopulation. Explain the rationale for the involvement of special classes of
subjects, such as fetuses, neonates, pregnant women, children, prisoners, institutionalized
individuals, or others who may be considered vulnerable populations. Note that 'prisoners'
includes all subjects involuntarily incarcerated (for example, in detention centers) as well as
subjects who become incarcerated after the study begins. List any collaborating sites where
human subjects research will be performed, and describe the role of those sites in performing
the proposed research.
b. Sources of Materials
Describe the research material obtained from living human subjects in the form of specimens,
records, or data.
Describe any data that will be recorded on the human subjects involved in the project.
Describe the linkages to subjects, and indicate who will have access to subject identities.
June 21, 2017 GE/EMF POC Challenge RFP 17
Provide information about how the specimens, records, or data are collected and whether
material or data will be collected specifically for your proposed research project.
c. Potential Risks
Describe the potential risks to subjects (physical, psychological, social, legal, or other), and
assess their likelihood and seriousness to the subjects.
Where appropriate, describe alternative treatments and procedures, including the risks and
benefits of the alternative treatments and procedures to participants in the proposed research.
2. ADEQUACY OF PROTECTION AGAINST RISKS
a. Recruitment and Informed Consent
Describe plans for the recruitment of subjects (where appropriate) and the process for
obtaining informed consent. If the proposed studies will include children, describe the process
for meeting requirements for parental permission and child assent.
Include a description of the circumstances under which consent will be sought and obtained,
who will seek it, the nature of the information to be provided to prospective subjects, and the
method of documenting consent. Informed consent document(s) need not be submitted to the
PHS agencies unless requested.
b. Protection Against Risk
Describe planned procedures for protecting against or minimizing potential risks, including risks
to confidentiality, and assess their likely effectiveness. Where appropriate, discuss plans for
ensuring necessary medical or professional intervention in the event of adverse effects to the
subjects. Studies that involve clinical trials (biomedical and behavioral intervention studies)
must include a description of the plan for data and safety monitoring of the research and
adverse event reporting to ensure the safety of subjects.
3. POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE SUBJECTS AND
OTHERS
Discuss the potential benefits of the research to the subjects and others.
Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to
subjects and others.
4. IMPORTANCE OF THE KNOWLEDGE TO BE GAINED
Discuss the importance of the knowledge gained or to be gained as a result of the proposed
research.
June 21, 2017 GE/EMF POC Challenge RFP 18
Discuss why the risks to subjects are reasonable in relation to the importance of the knowledge
that reasonably may be expected to result.
5. DATA AND SAFETY MONITORING PLAN (if applicable)
If your research includes a clinical trial, create a heading entitled "Data and Safety Monitoring
Plan." Provide a general description of a monitoring plan that you plan to establish as the
overall framework for data and safety monitoring.
12. LITERATURE CITED
13. APPENDIX
Include letters of support from the department chairs, and associate investigators (required).
No page numbering is necessary for Appendix. The appendix can include:
Up to 5 publications, manuscripts (accepted for publication), abstracts, patents, or other
printed materials directly relevant to this project. Do not include manuscripts submitted for
publication.
Publications in press: Include only a publication list with a link to the publicly available on-
line journal article or the NIH PubMed Central (PMC) submission identification number. Do
not include the entire article.
Manuscripts accepted for publication but not yet published: The entire article should be
submitted.
Manuscripts published but an online journal link is not available: The entire article should
be submitted.
Surveys, questionnaires, data collection instruments, clinical protocols, and informed
consent documents.
Full resolution images of gels, micrographs, etc., provided that a reduced size version is
also included within the page limit of Items a-d of the research plan. No images may be
included in the Appendix that are not also represented within the Research Plan.
Do not use appendix to circumvent page limitations for research plans. Do not include
experimental methods, protocols or figures that should be incorporated within the research
project description.
June 21, 2017 GE/EMF POC Challenge RFP 19
STATEMENT OF CONDITIONS GOVERNING THE GE/EMF Grant
It is understood that this Grant approved by the GE/EMF will be made with the following
conditions:
1. Institutional overhead is allowed up to 10% of the grant money. The overhead is assumed to
be included in the Grant payment itself and not in addition to the Grant.
2. All reports of work achieved with this grant will acknowledge the support of EMF and GE
Healthcare and his or her co-sponsor, if applicable.
3. Any discovery that arises from work supported in part by the EMF and GE Healthcare will be
submitted for publication. Two copies of each publication will be furnished to the EMF and GE
Healthcare.
4. Independent progress reports by the applicant will be submitted to the Emergency Medicine
Foundation mid-project, and within thirty days of completion of the funding period. Additional
reports may be required. EMF and GE Healthcare will maintain the copyright of all such reports.
5. Participation and presentations at a variety of committee and section meetings during
the October 2017 ACEP Scientific Assembly is required. The Principal Investigator will
develop and provide a short presentation of their research to garner votes for the
$150,000 supplement funding award. Grant money may not be used for travel to this
conference.
6. Participation in the EMF Grantee Workshop is required. EMF will reimburse travel expenses.
7. Participation in ACEP Research Forum to give a poster and lightning oral presentation is
required. This event takes place at the end of your project. Research Forum is held each year
during the ACEP Scientific Assembly. Grant money may not be used for travel to this
conference.
8. If all requirements are met, funding will begin in November 2017. EMF and GE Healthcare
reserve the right to terminate payments under this grant at its sole discretion.
9. If the named principal investigator leaves the institution or terminates research in the
designated field, all remaining funds, shall be returned to EMF. If unused funds exist at the
completion of the project, all remaining funds shall be returned to GE Healthcare.
June 21, 2017 GE/EMF POC Challenge RFP 20
Information about global prevalence of shock:
From the “World Sepsis Day” event and their materials, here and here, detail the prevalence
of just one of the four forms of medical shock globally. The papers mentioned above make
references to 30 other papers, so this is widely understood. This data alone would put Shock
above most other dangerous diseases:
This paper provides similar data.
Perhaps the most compelling data come from the Surviving Sepsis campaign which has been
widely respected by societies around the world. Here is a summary from one of the primary
authors, Dr. Mervyn Singer.
Here’s a reference to the >1M deaths in the USA. It is a reference to hypovolemic Shock only.
June 21, 2017 GE/EMF POC Challenge RFP 21
This paper covers the question of distributive Shock (of which Septic Shock is a subset). This
puts the global incidence of distributive Shock at just over 1.2M/year.
This paper, from the National Institutes of Health, covers the incidence of hypovolemic Shock,
mostly from trauma alone.
