DEFINITION OF A RESEARCH PROJECT AND SPECIFICATIONS FORFULFILLING THE REQUIREMENTAll Internal Medicine residents are required to complete a research project during their residency.A research project is a scientific endeavor to answer a research question. Research projects mayinclude:• Case series• Case control study• Cohort study• Randomized, controlled trial• Survey• Secondary data analysis such as decision analysis, cost effectiveness analysis ormeta-analysis.Each resident must work under the guidance of a faculty mentor. Depending on your area ofresearch interest or your research topic, you may be able to identify a mentor on your own, or ifneeded, you will be assigned one. You are also provided with a step-by-step guide to simplify theprocess and a suggested Timeline for research project completion to ensure that you meet yourrequirement in a timely manner.A GUIDE TO THE RESEARCH PROCESSI. SELECTION OF THE RESEARCH TOPIC: The first major challenge inconducting research• The easiest way is working with a faculty mentor who is active in research andmay have defined one or more researchable questions.• Consulting with leading faculty in your area of interest and asking for advice onresearchable topics is another avenue for research ideas.• Developing research ideas from loose ends discovered during: a) patient care, b)reading within an area, c) reviewing journal article(s), and d) discussions, critiqueof research articles in journal club, could be an interesting, and a rewardingexperience.II. DEVELOPING THE RESEARCH PROPOSALA research proposal helps you to develop your research idea into a valid, scientificresearch project. A general outline of the elements of a Research Proposal is presented.Although the Research Project Outline provides a description of all the elements of aresearch project, you are required to complete the writing up of the Methodology sectionBEFORE you begin project implementation. Writing of the research proposal has atwofold purpose: 1) it provides you, the researcher, with the blueprint for implementingyour project, and 2) it has to be submitted to the IRB Committee for securing IRBapproval to implement your project. Besides, it is easier to write up the Results andDiscussion sections once you have the preliminary sections in place.III. SECURING IRB APPROVALIRB approval has to be secured BEFORE you begin collecting your data. In order to doso, you need to send copies of your proposal, and patient Consent Form (for prospective,clinical trials) to the IRB ( The Vice Chair of Research (Dr.Nancy Connell) will review your IRB proposal prior to submission to double-checkformat and value.IV. PROJECT IMPLMENTATIONIn order to conduct a valid, scientific study, it is important that you rigorously follow thestudy design outlined in your research proposal and approved by the ResearchCommittee. Also, to ensure timely completion of your project, it is important that youstay within the framework discussed in the Timeline. A one to 3-month research electivecould be taken to provide you with the needed time.V. WRITE-UP OF PROJECT RESULTS AND DISCUSSIONThis should follow directly from your research proposal. The research project outlineprovides a ‘how to’ write-up of the results and discussion sections.VI. RESEARCH PRESENTATIONOnce your research project is complete, you have to make a public oral presentation topresent your work. A formal Research Presentation provides you with the opportunity toshare your research with your colleagues, and the department faculty, and provides youwith the confidence required to give presentations at regional and national conferences.OUTLINE OF A RESEARCH PROJECTI. TITLE PAGE (Page 1, DO NOT NUMBER)• Study Title• Names of principal investigator(s) and co-investigator(s)• Division• Department of Medicine• UMDNJ-New Jersey Medical School, Newark, New Jersey• Date: month and year proposal prepared/submittedII. SUMMARY (Page 2; up to 1/2 – 3/4 page; DO NOT NUMBER)The summary should be brief and include: 1) a few sentences introducing the topic ofcurrent study (could include a couple of references); 2) statement of the problem; 3) abrief description of the methodology to be used including duration of study, subjectselection criteria, tests to be performed, and/or data to be collected; 4) significance andimplications of the study (why is it important to do the study, and what are the benefits:fill in gap in knowledge; develop further understanding of a clinical situation; modifycurrent approach to treatment; cost-benefit analysis etc., etc.). Summary is usuallywritten AFTER you have finished writing your proposal. III.INTRODUCTION AND REVIEW OF THE LITERATURE (Page 3; up to 2 – 3pages; a minimum of 8 references required). This section consists of an overview of the research question and some indication of thestudy’s worth and the contribution it is apt to make to the field of study. It should includethe rationale for the research project. Use references to establish the link between theproposed study and previous work done on the topic, lay the groundwork for theproposed study, and demonstrate why it is important and timely. The literature review isnot just a compilation of facts, but a coherent argument that leads to the description of theproposed study. By the end of the literature review, the reader should be able to concludethat, “Yes, of course, this is the exact study that needs to be done at this time, to moveknowledge in this field a little further along.”IV. PROBLEM STATEMENT & RESEARCH HYPOTHESES (up to 1/2-1 page)The problem statement describes the problem posed by the proposed study and specifiesit in the form of Research Hypotheses. The research hypotheses should flow logicallyfrom the discussion presented in the Review of Literature and the Statement of theProblem. The hypotheses should be very specific in presenting what aspects of theresearch topic you will be studying, and how. The hypotheses should be optimally clear,concise, meaningful, and typically written in the present tense. One recommendedstatement of the criteria for a good hypothesis is that is: a) be free of ambiguity, b)express the relationship between two variables or concepts, and c) imply an empiricaltest. AVOID having more than one hypotheses embedded in a single, complex statement.A conceptual model represents a visual depiction of the relationship between all thevariables in your study. It is a good place to start when planning your research project,and also helps in developing your hypotheses.V. METHODOLOGY (up to 2-3 pages)1. Study DurationDescribe the time frame during for which data will be collected (retrospective study;chart reviews), or intervention administered (prospective study; clinical trials).2. Subject SelectionOf particular importance in this section are:a) the sampling procedure to be used – random, stratified, convenienceb) the source of the subjectsc) the criteria for selection – clearly state inclusion/exclusiond) the rationale for determining sample size – use power test to determine samplesize for significance; realistic estimates of crossovers, dropouts must be used incalculating sample size3. Instrumentation or MeasuresThis section lists all the variables (intervention as well as outcome variables) youwould be examining in your study, and describes what particular measures, or forms,or data collection sheets you will be using to measure the variables.4. ProceduresThis section provides a detailed description of the exact steps to be taken to conductyour research. This includes the procedure used to contact subjects, obtainingInformed Consent, and collecting the data. For prospective clinical trials, you haveto specify the way the intervention will be allocated (randomization, single blind,double blind), baseline examination, administer intervention, post-interventionexamination etc. You need to specify the termination policy for your study.5. Data AnalysisIn this section describe the statistical tests that will be used to address the researchhypotheses. Although intimidating, this section forces you to think how you willanalyze (or have it analyzed) at the time the proposal is generated rather than after thedata are collected. This way, you can avoid wasting time collecting data that are notanalyzable because they are not in the collected in the correct format.6. Study LimitationsDescribe the shortcomings and weakness of your study most likely to impact theinternal validity of your study.VI. RESULTSIn this section, you present your findings as clearly as possible. The Results sectioncontains JUST THE FACTS: tables, figures, transcript summaries, and your descriptionof what is noteworthy and important about these. Begin with a description of the sample.Simple demographics can be presented in tabular form. Follow with presenting yourfindings in terms of the research questions/hypotheses tested. VII.DISCUSSIONThis section typically contains: • an overview of significant findings• a consideration of the finding in light of previous research• a careful examination of findings that fail to support your hypotheses• limitations of the study that may affect the generalizability of the results• recommendations for further research• implications of study for professional practice VIII.REFERENCESYou must cite all studies referred to in the proposal, using the AMA citation method. INCENTIVES OFFERED BY THE DEPARTMENT OF MEDICINEFOR PRESENTING CASE REPORTSSubmitting write-ups or Case Reports for national and regional meetings and for theResident Research Day is encouraged and supported by the Department. The departmentstaff helps residents in every step of the process including providing assistance with thepaperwork required for submitting an abstract, preparing the poster (Ms. MarieBirthwright at Ext. 2449), as well as providing residents with extra days andreimbursement for all posters or oral presentations at state or national meetings.RESEARCH REQUIREMENT FOR ALL RESIDENTSDesigning, implementing, evaluation, writing up, and submitting a research project to theResearch Committee by February 28 of PGY3 meets the research requirement for allresidents. Please follow appropriate deadlines.PGY1Time Line for Research Project for PGY11. Mentor Assignment Sep 1/PGY12. Submit 3 research ideas to the Research Committee Jan 1/PGY13. Selection of 1 idea for research projectby the Research Committee Feb 1/PGY14. Submit literature review and researchhypothesis to the Research Committee(a minimum of 8 citations required; morewould be nice!) Mar 1/PGY1PGY2Continuation of research project initiated in PGY1. Please follow appropriate deadlinesfor PGY – 2.Time Line for Research Project for PGY21. Submit write-up on research design,methodology, data collection instruments, Patient selection criteria to the Research Committee2. Approval of research methodology by theResearch CommitteeJul 1/PGY2Oct 1/PGY2 3. Begin implementation of project Nov 1/PGY2PGY3Continuation of research project initiated in PGY1. Please follow appropriate deadlinesfor PGY-3.Time Line for Research Project for PGY31. Complete data collection July 1/PGY32. Complete analysis of results Nov 1/PGY33. Complete write-up of project includingResults, discussion, and conclusions;Submit to the Research Committee Feb 1/PGY3


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