Interested in Research? The Prehospital Research Council is designed to assist EMS providers in potential EMS research projects. If you or your agency has an idea, please complete this form and submit it to: [email protected]. **Please note: Not all ideas are able to evolve into a research project; the job of the committee is to assist you in the process. The following documents are for review only. Idea Development(Form1) to be completed at emi‐lvh.net Pre‐Hospital Form 2 Completed after Idea Development approval Blank PSF (Project Submission Form). This is a copy of the official document that needs to be reviewed for approval to begin the study. Pre‐Hospital Algorithm. This document will show you all the steps for the Research process.
Transcript
Interested in Research?
The Prehospital Research Council is designed to assist EMS providers in potential EMS research projects. If you or your agency has an idea, please complete this form and submit it to: [email protected]. **Please note: Not all ideas are able to evolve into a research project; the job of the committee is to assist you in the process. The following documents are for review only. Idea Development (Form1) to be completed at emi‐lvh.net Pre‐Hospital Form 2 Completed after Idea Development approval Blank PSF (Project Submission Form). This is a copy of the official document that needs to be reviewed for approval to begin the study. Pre‐Hospital Algorithm. This document will show you all the steps for the Research process.
Interested in Research?
The Prehospital Research Council is designed to assist EMS providers in potential EMS research projects. If you or your agency has an idea, please complete this form and submit it to: [email protected]. **Please note: Not all ideas are able to evolve into a research project; the job of the committee is to assist you in the process.
Have you searched for any previous studies published on the same topic? If so, what where they? _____________________________________________________________________________________________
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Department of Emergency Medicine Research Project Proposal Form
Have a research study idea? Great, read below to get started developing your study:
This process will be completed in two parts. Please read the directions carefully.
Forms must be typed and signed as indicated.
A senior research mentor, Dr. Marna Greenberg, Dr. Bryan Kane, Dr. Anita Kurt (Research Manager), or
Bernadette Porter (Research Coordinator) will be assigned to assist you with development and guidance
regarding the required research paperwork, in addition to any of the faculty members you are currently
working with to develop your study.
Complete a thorough literature search on your topic. Keep an electronic copy of all pertinent articles
and search engines, as you will need these for protocol development, copies for mentors and
publications.
You will be provided with a two-page Project Development Form (Part I). Obtain guidance and input
from research team members, faculty members and research mentors, as applicable.
Call Bernadette Porter, Emergency Medicine Research Coordinator, at (610) 402-7262 to schedule time
at the Research Idea and Development meeting for study review by the senior research team , which is
held the 2nd Tuesday of every month @0800 in the Residency Suite at the Muhlenberg site.
Send electronic copies of all pertinent journal articles (keeping separate copies of the articles for
yourself) and Part I of the project submission form to Bernadette Porter in Emergency Medicine
Research.
Attend the Research Idea and Development meeting.
Take information obtained from the literature, Idea and Development meeting, mentors, research team
and faculty members, and develop your protocol.
Once finalized, send an electronic copy of protocol to Bernadette Porter for input regarding the
appropriate IRB submission category.
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Complete the necessary IRB Forms, and send the protocol and Part II of the project submission form
with the appropriate signatures, to Bernadette Porter to be placed for review on the ED Research
Committee Meeting agenda, which is held the first Tuesday of every month @ 0800 in ECC#4.
Implementation of research in the Emergency Department requires the PI or a designated
representative, who is familiar with this study, to attend the Research Committee Meeting, for final
proposal review and approval. All research studies conducted in the Emergency Department must be
reviewed for patient risk and scientific validity by the ED Research Committee.
It is mandated that the PI or a designated representative, attend the ED Research Committee meeting.
The PI or a designated representative must know the study proposal well enough to present it, answer
any questions the committee presents, and take the suggestions of the committee back to the PI, if a
team member is in attendance on the PI’s behalf. In addition, it is the responsibility of the PI, or
designated representative, to record all suggestions and recommendations made by the Committee,
and to make the necessary changes to the study proposal before submitting the final copy
electronically to Bernadette Porter.
Research Committee Meetings are held the 1st Tuesday of every month and the Research Idea and
Development meetings are held the 2nd Tuesday of every month. Please contact Dr. Anita Kurt, (610)
402-7666, or Bernadette Porter, (610) 402-7262, if you need to be placed on the meeting agendas or
have any questions.
This is an INTERNAL document that is to be held in strict confidence. The ideas suggested hereafter are
the intellectual property of the Principal Investigator (PI), and therefore permission by the PI *MUST* be
granted before any information is shared with those who are not indicated as team members.
Research proposals and ideas should under NO circumstances be shared outside the Research
Committee and study Team Members.
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Project Development Form Part I
Study Title: Research Question: Background/Significance: Study Hypothesis (Alternative Hypothesis): Null Hypothesis: Independent Variables (Intervention/Predictor Variable): Dependent Variable (Outcome Variable):
Project Design: Objective: Inclusion Criteria: Exclusion Criteria: Procedures: Population and Sample Studied: Proposed Study Measurements
Measurement Scales - Nominal/Categorical Data – Ordinal Data – Interval Data- Ratio Data-
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Definitions of Headings Study Title: (Please work with your senior research mentor for assistance in completing this form.) Research Question: (Research questions often address the effect of an intervention on an outcome. The characteristics of a good research question are that is feasible, interesting, novel, ethical and relevant. Four elements of a well written research question include the patient or population to be studied, the intervention or treatment, the comparator intervention, if applicable, and the outcome. Studies can have more than one question, but it makes it easier to focus on one primary question and add other questions on as objectives within the study.) Significance: (Why is this research important, how is it significant to medical knowledge or practice?) Study Hypothesis (Alternative Hypothesis): (This is the hypotheses that is not directly tested, but is the proposition that there is an association among the intervention--i.e., the predictor/independent variable--and your outcome, or dependent, variable.) “Null” Hypothesis: (This is the hypothesis that is the formal basis for testing statistical significance. The null hypothesis states that there is no association between the intervention (predictor/independent variable) and your outcome, or dependent, variable.) Directional hypotheses specify the direction of the association between the predictor and outcome variables, and are considered one sided hypothesis. Non Directional hypotheses state that an association exists and they are considered two sided hypotheses. Independent Variable (Intervention/Predictor Variable): Dependent Variable (Outcome Variable): Project Design: (First choose if your study is “descriptive,” i.e., it describes the incidence of outcomes, or “analytic,” i.e., it analyzes the associations between predictions and outcomes. Then choose if your study will be completed “retrospectively,” after* the outcomes have occurred, or” prospectively,” before* the outcomes have occurred.) For example,” this is a prospective, descriptive study examining the incidence of…” Objectives: Inclusion Criteria: (This will be the selection criteria that will help define the population you wish to study.) Exclusion Criteria: (This will indicate subsets of individuals who would be suitable to the research study if it were not for a characteristic that may interfere with the quality of data. Utilize the exclusion criteria to control for the confounders of the study, if possible.) Procedures: (Describe in detail the procedures necessary to conduct the study.) Population and Sample Studied: (The population is a complete set of people with a specified set of characteristics and the sample is the subset of that population that you will be studying.) Proposed Study Measurements: Measurement Scales: (Please define measurement scales. An important rule of measurement is that one should use the highest level of measurement possible. The level of measurement is associated with the types of statistical analysis that will be performed on your data. Whenever possible, utilize validated instruments for measurement/study tools, but approval for use may be necessary. Please describe the type of data you will be collecting, as you may have several different types.) Nominal/Categorical Data: (Names or Words, unordered categories Example: Gender, Marital Status, Ethnicity, Diagnosis.) Ordinal Data: (Assigned to categories that are ranked, but the intervals between the ranked categories are not equal, e.g., Likert Scales or semantic scales.) Interval Data: (Scales that are numerically equally or a continuum of values, but does not have a zero point, e.g., Visual Analog Scale, Temperature, Age.) Ratio Data: (Highest form of measurement, meets all criteria of interval data, but has an absolute zero point, e.g., Weight, length, volume.)
PROJECT DESCRIPTION
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PART II
(to Research Committee Meeting)
Project Name:
Date:
Principal Investigator (PI):
Contact Information: Office: Fax: Pager:
Team Members: (include any nurses, residents, administrative assistants, attending physicians, pharmacists, grant writers, statisticians or others you think may be involved)
Project Manager:
Grant Manager: Source of Funding:
Anticipated Study Authors: (please list anticipated authors in order of contribution, from most to least, using the guidelines described to the right) 1st Author: Last Author: 2nd Author: 3rd Author: 4th Author: 5th Author: 6th Author: 7th Author: 8th Author Other contributing members: Give an example of a journal you would consider submitting your research? The Principal Investigator ultimately has the right to determine authorship.
Authorship Guidelines: 1st Author: must contribute 4 of the below 2nd Author: must contribute 3 of the below Consecutive Authors: must contribute at least 2 of the below Contributions: Conceive and develop idea Actual execution of study Analysis and interpretation of data Writing and revising of manuscript
Category of Project: (circle one)
Grant Application (includes federal, state, local, Pool, Anderson, etc.) Original Research Proposal Grant Funded (gathering new data) Original Research Proposal Currently Not Funded (gathering new data) Original Research on Performance Improvement Protocols or Departmental Processes that uses existing data. Participation in a Multi-Center Grant Funded Research Project Writing a manuscript that does not involve the gathering of data. Other ____________________________________________
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Risk to Subject: (Please check one, either minimal risk or greater than minimal risk.)
MINIMAL RISK GREATER THAN MINIMAL RISK Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests. Consent Needed: YES NO If greater than minimal risk, the following questions should be considered when designing your study. These questions will require answers for your IRB submission:
1. Are the research procedures the least risky procedures that can be performed consistent with sound research design? (please explain)
2. Is the proposed research of sufficient importance to justify the risks entailed? (please explain)
Non-Departmental Resources: (Estimate the number of hours and / or type of resources needed. If this is anything more than trivial work, we encourage you to have the individual initial next to their planned input either before or immediately after Research Committee approval. We encourage the non-EM individual to get approval from their supervisor before signing on.) None.
SIGNATURE
Principal Investigator:
Date:
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Research Committee Review
Project Timeline: (Estimate the date of completion for the following milestones. Timelines are subject to change depending upon IRB approval, and needed resources. This is a department specific timeline only and not to be sent to the IRB.)
1. Literature review (has the project already been done/can we contribute something new?): 2. Research design: 3. IRB approval: 4. Database construction: 5. Data collection: 6. Data analysis: 7. Scientific meeting presentation: 8. Manuscript submission:
Resources Required: (Please include the initials of your team members who will participate in the following steps.)
1. Literature review: 2. Research design: 3. IRB approval: 4. Database construction: 5. Data collection: 6. Data analysis: 7. Scientific meeting presentation: 8. Manuscript submission:
Committee Members present at review: (please check all members who were present for the review meeting)
David Burmeister, DO Chairman of Emergency Medicine
Richard MacKenzie, MD Senior Vice Chairman of Emergency Medicine
Alex Rosenau, DO Vice Chairman of Emergency Medicine
Dave Richardson, MD Associate Vice Chairman of Emergency Medicine
Marna Greenberg, DO Director of Research, Emergency Medicine
Bryan Kane, MD Assistant Program Director, Resident Research
Gavin Barr, MD Director, Industry Research, Emergency Medicine
Jeanne Jacoby, MD Emergency Medicine Physician
Andrew Martin, RN Director, 17th & Chew Emergency Department
Teresa Wigoda Administrator, Emergency Medicine
Anita Kurt, PhD, RN Research Manager, Emergency Medicine
Bernadette Porter, BS, CIM Research Coordinator, Emergency Medicine
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Scientific Attestation Emergency Medicine Research
Department Review Form
Proposed Project Title: Principal Investigator (PI):
The following questions must be reviewed by the Research Committee as part of the project submission process, before submitting to the Institutional Review Board (IRB).
Marna R. Greenberg, DO, MPH Date Director of Research __________________________________________ _________________ Emergency Medicine Date Administrator
Are the research procedures the least risky procedures that can be performed consistent with sound research design?
Yes
No
Are the risks reasonable in relation to the anticipated benefits?
Yes No
Is the proposed research of sufficient importance to justify the risks entailed?
Yes
No
Is the research likely to achieve its aims?
Yes No
Are there adequate resources (i.e., facilities, qualified staff, time to complete the study and access to population) that will allow recruitment of the required number of participants?
Yes
No
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Investigator Agreement for Original/Industry Research
FDA {21 CFR 50.3(25)(d)} defines an investigator as the following:
Investigator means an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.
I understand that as the Principal Investigator (PI) of this research study, I will play the primary role in developing or conducting a research protocol that contains all ethical, legal and scientific information required to properly conduct this research study, and I will personally conduct the research study as it is described in the research protocol. I understand that as the PI, I am personally responsible to annually monitor the study for validity, and update with current literature throughout the continuation of the study. I will provide copies of the research protocol to all Co-Principal Investigators (CoPI), Sub-Investigators (SI), and other professional personnel who will participate in conducting this research study, with the understanding that this is a confidential protocol and is not to be shared with any non-study personnel. I will review and discuss the protocol with these individuals to ensure that they are completely clear of how the study will be conducted, and the role that will play in conducting this research study. I am aware that this protocol must be reviewed and approved by the Emergency Medicine Research Committee (which meets the first Tuesday of every month) and that I or a delegated study representative am/is responsible for presenting this protocol at that meeting. Additionally, I am aware that this protocol must be reviewed and approved by the Institutional Review Board (IRB); and once approved, that all study personnel will strictly adhere to the approved research protocol. In addition, I understand that any change to the research protocol must be amended with the IRB, and once the amendment had been approved, that all study personnel will strictly adhere to the amended research protocol. I agree to provide all study participants (and/or authorized representatives when appropriate) with signed copies of informed consent forms as regulated by both government and International Conference on Harmonization (ICH) regulations. I agree to report any protocol deviations/violations, severe adverse events (SAEs), or adverse events (AEs) in compliance with the IRB, Food and Drug Administration (FDA), and departmental regulations. Further, I agree to report all required information regarding financial disclosure for myself (the PI), all CoPIs, SIs, and other study personnel to the IRB in compliance with FDA regulations. I declare that my participation in this research study will be conducted in compliance with all requirements to be laid forth in this protocol, IRB guidelines, FDA, and departmental regulations. ______________________________________ ________________________________________ Tara Henry, EMT-P Date Signature Date Principal Investigator Principal Investigator
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STAFF EDUCATION FOR NEW RESEARCH STUDY
(The staff education form will be distributed to every staff member in the ED for educational purposes once your study is approved.)
STUDY TITLE:
STUDY SUMMARY: (In two to three sentences, briefly describe the research study. Include major INCLUSION criteria.)
STUDY MEDICATIONS OR PROCEDURES AND COMPARATOR MEDICATIONS OR PROCEDURES: (Briefly describe the study medications and comparator medications or study procedures, if applicable.)
EMERGENCY DEPARTMENT RESOURCES: (Please list any resources needed from a ED standpoint, i.e., labs, observations, recording of times, form completion, etc.) **Whenever possible, research procedures should be completed by a Research Coordinator, so it does not impact the flow of the Emergency Department.** Physician Resources: Nursing Resources: Department Resources:
RISKS/SIGNIFICANT SIDE EFFECTS: (Please list any risks or significant side effects that the nurses and physicians should be aware of when enrolling patients in this study.) If you have a patient who meets the above criteria, please call Bernadette Porter, Research Coordinator, at (610) 402-7262 or Anita Kurt, Research Manager, at (610) 402-7666.
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Research Development Process Flow Chart
Develop Idea
Find a Mentor
Wait for the approval letter from the Dept. Research
Committee (meets 1st Tuesday of the month)
Complete e-IRB documents with the study coordinator
Literature Search (Need paper or
electronic copies of all related articles.)
Work with the assigned study coordinator as needed to develop your protocol, and
if possible, include a flow diagram of the study.
IRB Approval
Attend Research Idea & Development meeting
(meets 2nd Tuesday of each month) and consult with
statistician
Apply for grant funding through Anita Kurt @
610-402-7666
Conduction of Study
For needed funding, contact Anita Kurt to
apply for grants
Complete CITI Training and COI Statement
Data Analysis
Write Manuscripts
Complete NORI paperwork with the study coordinator
and submit
Submit completed Project Submission Form to Anita
Kurt at least two weeks prior to the Dept. Research meeting
VERY IMPORTANT: DO NOT COLLECT ANY DATA PRIOR TO THE STUDY WITHOUT APPROVAL FROM LEHIGH VALLEY HOSPITAL NETWORK’S IRB.
Research Proposal FORM 1 submitted to Council for review.
Proposal Process
FORM 1 is DECLINED.
Submitter presents idea at Council meeting.
Head of Council/Designated Council member brings proposal to Emergency Medicine.
FORM 1 is APPROVED.
FORM 2 is DECLINED FORM 2 is APPROVED.
Decision letter is mailed to submitter. Medical Director is copied. Submitter receives a follow-up phone call from Head of Council
encouraging future submissions and explaining why project
cannot be pursued.
NO FURTHER ACTION REQUIRED.
Letter is mailed to submitter inviting him/her to attend the following month’s Council
meeting where he/she is to present the idea to Council. Medical Director is copied.
Council DECLINES proposal for presentation to EM.
Council APPROVES proposal for presentation to EM.
Final letter is mailed to submitter informing him/her that idea has been approved by Council and is being forwarded to the EM Research Committee. Medical Director is
copied on this letter.
**Due to State limitations concerning certain types of
research, Council should determine it has clearance
before sending out FORM 2.
As soon as possible after the Council Meeting, FORM 2 will be given to the
provider requiring further detail. Project Liaison explains/encourages a literary search
be performed.
Decision letter is mailed to submitter. Medical Director is copied. Submitter receives a follow-up phone call from Head of Council
encouraging future submissions and explaining why project cannot be pursued.
NO FURTHER ACTION REQUIRED.
Research Proposal FORM 2 submitted to Council for review.
Final decision letter is mailed to submitter. Medical Director is copied. Submitter receives a follow-up phone call from Head of Council encouraging future submissions and explaining why
