ࡱ> ;=:m (bjbjzz 4*bbff $!.....   -!/!/!/!/!/!/!$|#2&S!9X  XXS!..!X ..-!X-!V@ .j׼b  !!0! x@'l(@' @' 09"[w   S!S!   !XXXX@'         fB : Research Project Proposal Format for Investigator-Initiated Research Scientific Review Committee/Institutional Review Board University of Tennessee College of Medicine Chattanooga & Erlanger Health System General guidelines for proposal submission Number all pages Place title on all appendices First person language should not be used Proofread the proposal carefullyspelling and grammar check programs miss many errors All abbreviations should be defined with first use in the document Format of proposal submission Title Page Title of Project Identify Principal Investigator, Institution, Department Affiliation Identify all Co-Investigators, Institutions, Department Affiliations Abstract/Project Summary Should be d"350 words Should contain most critical background and methodology information Bibliographic references should not be used in the abstract Hypothesis State hypothesis/hypotheses to be tested Specific Aims List specific aims in decreasing order of importance Specific aims can be subdivided into primary and secondary aims, if necessary Background/Significance Should be thorough and clearly cover the current literature in the area to be studied References are required for all work cited and should be cited numerically in order used in the document Use the most recent reference sources that are relevant to the proposal This section should end with a description of how the proposed study will add to the current body of knowledge Preliminary Work Any preliminary work done by the current investigators relevant to this study should be included here Many investigators will leave this section blank for a new area of study Methods Study Design Describe the study design Give rationale for choosing the study design Study Subjects Describe process of subject selection Inclusion criteriashould be very specific and listed in numeric or bulleted form Exclusion criteria should be very specific and listed in numeric or bulleted form Describe process of control selection, if using controls Sample Size Explain total number of subjects to be tested Justify number of subjects to be treated Describe statistical methods used to determine adequate sample size Show effect size, alpha (standard is 0.05), and beta (standard is 0.8) If local subject numbers are insufficient, describe plan to address suboptimal sample size (partnership with other researchers, increased recruitment area, etc.) Data Collection Define data points to be collected Give rationale for any specific date ranges used to define data set Describe which data points represent study outcome variables Include any forms to be given directly to subjects exactly as will be used in the study Include form to be used for investigator collection of data (see appendices) If laboratory techniques are to be used, describe in detail Data Handling Describe how data will be collected and stored Explain steps taken to assure accurate and complete data collection Describe steps taken to ensure security of any confidential information to be collected during study Data Analysis Explain detailed plan for analysis of data Describe statistics to be used How will analyses performed test study hypotheses and specific aims? Describe expected formats for presenting results Time Frame Detailed and realistic time frame for subject recruitment and participation Time frame for completion of entire study (including analysis) Strengths/Innovation Describe the strengths of the study proposed Describe specifically how this study will enhance the current body of knowledge Limitations Describe potential problems that may arise and plans to address these problems Describe potential confounding variables in the study and plans to account for the confounders Risks and Benefits to Human Subjects, Animal Care, Hazardous Materials Risks to Study Subjects All studies collecting patient data have the risk of accidental disclosure of protected health information Direct Benefits to Study Subjects Benefits to Society If animals to be used, provide detailed plans describing number of animals, plans for the care and disposal of the animals If hazardous materials to be used, describe detailed plans for safe use, storage, and disposal of materials Discuss ethical concerns involved in conduct of the proposed study Budget/Research Environment (facilities, clinical space, etc.) List total cost to be incurred to complete study Identify source of funding for study conduct If multiple areas of cost to study, itemize budget as appropriate References Cited List relevant literature to the proposed study Make every attempt to cite the most recent and relevant literature in the area to be studied Appendices Data Collection Form that will be used to collect actual study data, most often in one of the following formats May be Excel spre EF  ( L ^ ` " ^ f h i y # ; BrzUhiʾh]k$h>" hQb5>*hQbhr=hQbhr=5>*hQbhQb5>*h0~h0~hs.CJaJhEPih0~5CJaJh0~h0~CJaJh0~h0~5CJaJh0~5CJaJhQb5CJaJh0~h0~5CJaJ2EF} ) R  * L ` " ^ i  & Fgdr= & Fgdr= & FgdQb & Fgdr=h^hgdQb$a$gd0~ # ; B)rzVG & Fgdr= & FgdQb & Fgdr= & FgdQb & Fgdr= & Fgdr=ijQ .0VWxS\ghi;>EPd(((Uh}uh7h0~h(2hQ5hnhr=h>"hQb hQbhQb:t( F(GSh@ & Fgdr= & Fgdr= & Fgdn@i9fEP:(((( & FgdQb & Fgdn & Fgdr= & Fgdr= & Fgdr=adsheet or similar file if collecting data electronically May be Word document or similar file if using paper for data collection Any survey or measurement tool to be given directly to the subjects Previous publications of preliminary work, if any 21h:pn/ =!"#$% s2&6FVfv2(&6FVfv&6FVfv&6FVfv&6FVfv&6FVfv&6FVfv8XV~ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@_HmH nH sH tH @`@ NormalCJ_HaJmH sH tH DA D Default Paragraph FontRiR  Table Normal4 l4a (k (No List HH ]k$ Balloon TextCJOJQJ^JaJPK![Content_Types].xmlN0EH-J@%ǎǢ|ș$زULTB l,3;rØJB+$G]7O٭Vc:E3v@P~Ds |w< g*i( @(8@0(  B S  ?a" b" c" =*urn:schemas-microsoft-com:office:smarttags PlaceType=*urn:schemas-microsoft-com:office:smarttags PlaceName9*urn:schemas-microsoft-com:office:smarttagsplace  ;>SV.DfVKr_ ml9!Zn(p;808^8`0o(.^`o(.$ $ ^$ `o(. @ @ ^@ `hH. ^`hH. L^`LhH. ^`hH. ^`hH. PLP^P`LhH.^`OJQJo(hH^`OJQJ^Jo(hHopp^p`OJQJo(hH@ @ ^@ `OJQJo(hH^`OJQJ^Jo(hHo^`OJQJo(hH^`OJQJo(hH^`OJQJ^Jo(hHoPP^P`OJQJo(hHh^`OJQJo(hHh^`OJQJ^Jo(hHohpp^p`OJQJo(hHh@ @ ^@ `OJQJo(hHh^`OJQJ^Jo(hHoh^`OJQJo(hHh^`OJQJo(hHh^`OJQJ^Jo(hHohPP^P`OJQJo(hHV.Dr_!Znq                          ww G]k$0(24B5l=r=D4JEPiz"mQ57NQbun4s.X 0~>"24K*G}u@48@8 8@8P@UnknownG*Cx Times New Roman5Symbol3.*Cx Arial5. .[`)Tahoma?= .Cx Courier New;WingdingsA$BCambria Math"hbgbgbg # #!r4 3QHP)?u2!xx NResearch Project Proposal Application Form for Investigator-Initiated ResearchEric J. Gratias, MDHendricks, Stacey   Oh+'0 ,8H dp    PResearch Project Proposal Application Form for Investigator-Initiated ResearchEric J. Gratias, MDNormalHendricks, Stacey2Microsoft Office Word@@D=׼@׼@׼ ՜.+,08 hp|  EHS#  OResearch Project Proposal Application Form for Investigator-Initiated Research Title  !"#$%&'()+,-./013456789<Root Entry FPj׼>1TableX'WordDocument4*SummaryInformation(*DocumentSummaryInformation82CompObjr  F Microsoft Word 97-2003 Document MSWordDocWord.Document.89q