Proposal Writing. J. Daniel Stanley, MD Dept. of Surgery September 11, 2009

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1 Proposal Writing J. Daniel Stanley, MD Dept. of Surgery September 11, 2009

2 What it is: Research Proposal

3 Research Proposal What it is: A required step in the process of initiating research activity A tentative working document A tool for refining the proposed project A checklist verifying adequate preparation for the project

4 Research Proposal.a written document that describes a research protocol and the administrative support required to successfully complete the planned research. Essential, concise and explicit From the Research Manual for Faculty, Residents, and Medical Students UTCOM Chattanooga

5 Research Proposal What it is not A summary of the project that you have just completed A document that is completed prior to choosing a mentor Optional

6 Reason for the Proposal Process Quality Research Ethical Research Efficient Use of Resources Educational Opportunity Quality Publications Required by the University IRB Process Required by Federal Law

7 UTCOM UTCOM has signed a Federalwide Assurance (FWA) for Human Subject Protections document with the federal government assuring that they would abide by the federal regulations regarding the conduct of human research by its students and faculty

8 The IRB IRB Approval Required by Law if: Funded or regulated by federal government Involves human subjects Is research (Excludes CQI) IRB Approval Required by UTCOM

9 Types of IRB Review Full Committee Review Expedited Review Review for Exemption Status See cfr46.htm and for approval requirements.

10 Consequences Suspension of project Suspension of all of a PI s projects Inability to use data or publish results Notification of sponsors, regulatory and funding agencies of noncompliance Debarment by FDA from using investigational products Exclusion from federal grants Increased monitoring Loss of licenses Shut down of ALL research at an organization

11 Cycle of Research Choosing a research question Developing a written protocol Pretesting and revising the protocol Implementing the study Analyzing the findings Drawing conclusions Communicating the results

12 Sequence of Events Get a Computer, Internet Access and Become Familiar with the Resources, Requirements and Literature Define a Research Question Identify and Engage a Mentor Write a Research Protocol Write a Research Proposal Make Revisions Get Approval Pick up your Check in Sweden

13 People to Know Gregory Heath, DHSc, MPH gregory Director of Research B.W. Ruffner, MD Institutional Review Board Chairman Manoo Bhakta, MD Institutional Review Board Chairmain Elect Eric Gratias, MD Scientific Review Committee Chairman Stacey Hendricks, CIM IRB Administrator Sylvia Friedl, BA, CIP Research Compliance Officer

14 Web Site

15 Define the Research Question/Idea Maintain a Curious and Critical Attitude Read Journals Attend Meetings Create or Become Familiar with Data Bases Is the Idea FINER? Feasible Interesting Novel Ethical Relevant

16 Identify a Mentor May be Done Before or After a Research Question is Identified Available Knowledgeable

17 Timeline and Checklist Make a timeline for the Cycle of Research Maximize research rotation by preparing protocol and proposal prior to research rotation Know dates and deadlines for SRC and IRB Anticipate need for continuity in ongoing studies Part of feasibility assessment

18 Who is it for? The Scientific Review Committee (SRC) The Institutional Review Board (IRB) Funding Entities Collaborators Yourself

19 What is the purpose of the SRC? A Purpose: to ensure that the scientific question being asked is relevant and that the design of a study is appropriate to answer that question. B

20 What does the SRC look like? A B

21 It depends on the quality of the Proposal C

22 SRC All projects with the exception of case reports are sent first through the SRC. SRC chair may exempt from review if has had previous scientific review

23 Death spiral

24 SRC Proposal Checklist Use the Research Project Proposal Application Form as a checklist for writing the proposal

25

26

27 Title Page Title of Project Investigators, Institution, Department Affiliations

28 Authorship Responsibility ICMJE, Vancouver Definition Each author should have participated sufficiently in the work to take public responsibility for the content.

29 Authorship Credit Vancouver Definition Based only on substantial contributions to [a] conception and design, or analysis and interpretation of data; and to [b] drafting the article or revising it critically for important intellectual content; and on [c] final approval of the version to be published. Conditions [a] [b] and [c] must all be met Consistent with "Uniform Requirements for Manuscripts Submitted to Biomedical Journals" (Ann Int Med 108: , 1988) with UTCOM Policy, Research Manual

30 Abstract / Project Summary Less than 350 words. Give a narrative with background information and a statement of the problem which needs to be addressed. Reveal the design and methodology cohort study, cross sectional, case control, double blinded prospective randomized trial etc. Statement regarding population, and methods of the study (intervention, predictor and outcome variables etc) and type of analysis

31 Hypothesis / Specific Aims State the hypothesis List the specific aims in decreasing importance Aims may be subdivided into primary and secondary aims if needed

32 Example Hypothesis and Aims: We hypothesize that treatment with Chlorhexidine baths and Mupirocin nasal ointment will significantly reduce the risk of developing invasive MRSA infections in critically ill trauma patients. Specific Aims: Does decolonization treatment actually induce decolonization of MRSA bacteria from the nares? Does decolonization treatment significantly reduce the risk of developing invasive MRSA infections in the trauma patient population? Determine if the same isolates are inducing MRSA colonization and invasive infections by identifying isolate strains and virulence factors. Does decolonization treatment reduce hospital and ICU lengths of stay, mechanical ventilator requirements, and death rates?

33 Background/Significance Cover Current Literature Give References Justify Study as Contribution to Body of Knowledge

34 Preliminary Work Data From Pilot Studies Data from Related Study Preliminary work is not initial work done without SRC/IRB approval Leave Blank for New Area of Study

35 Methods Describe study design and give rationale Reference and include with submission an investigators protocol manual if needed Study subjects Process of selection Inclusion/exclusion criteria Control selection Sample Size Consult with statistician and methods for the determination (Dr. Loizeaux is on the SRC as is Dr. Gregory Heath)

36 Methods Continued Describe predictor variables and interventions Data Collection Define data points and which represent outcome or endpoint Include all forms such as questionnaires Data sheets Describe type of data such as lab tests Data handling

37 Methods Continued Data Analysis Time Frame Strengths/Innovation Limitations

38 Risks and Benefits Risks and Benefits to Human Subjects Benefits to Society Hazardous materials Ethical Concerns

39 Ethics The most effective ways students can learn about professional values and ethical issues and standards are by interaction with faculty in research work and by informal discussion of ethical problems as they occur. Ritter, C&EN / Nov. 12, 2001

40 Budget/Research Environment Cost (routine vs. study related) Funding Sources Include Consent and Feasibility of Participation of EHS

41 IRB Checklist

42

43 IRB Proposals Form A and Follow the IRB Checklist if submission is for Full or Expedited Review Form B if an exemption is being requested Form H for Waiver of Consent may be sent along with form B and in some cases such as case reports and chart reviews may be sent without form B

44 Presenting to the SRC/IRB Be there Bring your mentor Invite departmental coordinator Be prepared Take notes Be open minded Utilize SRC/IRB members as a resource during preparation and revision of protocol and proposal

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