PILOT AND FEASIBILITY PROJECT PROGRAM REQUEST FOR APPLICATIONS (RFA) and APPLICATION SUBMISSION GUIDELINES FUNDING CYCLE KEY DATES

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1 PILOT AND FEASIBILITY PROJECT PROGRAM REQUEST FOR APPLICATIONS (RFA) and APPLICATION SUBMISSION GUIDELINES FUNDING CYCLE OVERVIEW KEY DATES RFA Release Date: Mnday, March 17, 2014 Statistical Cnsultatin Request Pririty Date: Wednesday, April 9, 2014 Letter f Intent Due Date: Wednesday, April 9, 2014 Applicatin Due Date: Wednesday, April 23, 2014 Earliest Anticipated Funding Date: June 2014 The Center fr Oral Health Research (COHR) Pilt and Feasibility Prject Prgram aims t facilitate innvative basic, translatinal and clinical research specifically in the area f ral and cranifacial bilgy. The ultimate gal f the prgram is t prvide adequate resurces and training fr pilt investigatrs t develp sufficient preliminary data t prepare a cmpetitive extramural research grant applicatin that will directly utilize ne r mre f the COHR Cres. The prgram will have a three part fcus with a missin t: 1) attract junir faculty withut prir extramural funding t ral healthrelated research; 2) enable established COHR investigatrs t explre an area that represents a significant departure frm their current wrk, and 3) entice established investigatrs in ther areas f bimedical research t apply their expertise t an ral health-related prblem. It is envisined that the prgram will enable investigatrs t frm interdisciplinary, interactive, and sustainable research studies that will impact ral and cranifacial health. PILOT PROJECT CATEGORIES The COHR Pilt and Feasibility Prject Prgram will supprt three general grant categries: Early Career, New Directin, and Nvel Methds & Technlgies. Grant Categries Brief Descriptin Award Amunt Award Duratin Early Career Discvery grant fr junir faculty within 6 Up t $30,000 Up t 1 year years f first full time faculty appintment and n prir extramural funding as Principal Investigatr. Mentr required. New Directin Faculty f any rank wh are substantially Up t $30,000 Up t 1 year changing research directin. Nvel Methds & Technlgies Faculty f any rank wh wish t develp a nvel methd r technlgy. Business plan may be required. Up t $30,000 Up t 1 year TO APPLY: Access the applicatin submissin prtal at: SCIENTIFIC SCOPE AND COHR CORES: Further infrmatin can be fund at: PROGRAM QUESTIONS: Cntact Carline Westwater, PhD westwatc@musc.edu Phne: ADMINISTRATIVE QUESTIONS: Cntact LuAnne Harley harleylu@musc.edu Phne: Page 1

2 KEY ELEMENTS OF THE COHR PILOT AND FEASIBILITY PROJECT PROGRAM The main bjective f the prgram is t prmte the grwth f the COHR thrugh the develpment f new extramural funding and the utilizatin, enhancement and advancement f critical technlgies and COHR Cre services. The pilt prject prgram is nt designed t prvide nging supprt fr a lng-term prject r t prvide supplemental supprt t nging funded research prjects. PILOT PROJECTS MUST AIM TO: Address an imprtant questin in basic, translatinal and/r clinical research that impacts ral and cranifacial bilgy-related science (ALL Grant Categries). Generate critical preliminary data t supprt the submissin f a cmpetitive extramural grant applicatin that will directly utilize ne r mre f the COHR Cres (Early Career and New Directin grants). Develp a new methd r technlgy that will directly enhance, advance r replace ne r mre functins r services within a designated COHR Cre (Nvel Methds & Technlgies grants). PILOT GRANT CATEGORIES 1. Early Career Pilt Prject (up t $30,000/prject/year) Early Career Pilt Grants will be available t newly independent faculty members with n prir significant external grant supprt as Principal Investigatr wh wish t develp an independent prgram f research that cmplements the fcus f the COHR. Fr this mechanism, significant external grant supprt is defined as a NIH R01, P01 subprject r equivalent. Applicatins in this categry must include a Pilt Prject Mentr wh will prvide a detailed letter f cmmitment describing the mentring arrangement (e.g., frequency f meetings, access t space and/r equipment) and fcal areas (knwledge, techniques r skills) critical t the prjects utcme and the pilt investigatr s research career develpment. The Pilt Prject Mentr may be frm inside r utside MUSC, but cannt be a prir r current supervisr r preceptr. The Pilt Prject Mentr may receive a $3,000 COHR Cre Vucher per year as recgnitin/cmpensatin fr their mentrship. 2. New Directin Pilt Prject (up t $30,000/prject/year) New Directin Pilt Grants will be available t faculty members f any rank whse prpsal is directly relevant t the COHR missin. T be cnsidered a new directin, the prpsed research must incrprate ideas and aims that are substantially different frm thse already being pursued by the investigatr. Prpsals in this categry must include a cmpelling ratinale and timeline that clearly establishes the direct relevance t the COHR s missin, the Principal Investigatr s qualificatins and resurces t undertake a new line f investigatin and a viable plan fr btaining cmpetitive extramural grant funding. 3. Nvel Methds & Technlgies Pilt Prject (up t $30,000/prject/year) Pilt Grants fr Nvel Methds & Technlgies will be available t faculty members f any rank, including but nt limited t existing COHR Cre persnnel, wh are in a psitin t carry ut a feasibility study t demnstrate the utility, practicality and ptential advantages f an innvative methdlgy r technlgy that wuld directly enhance, advance r replace ne r mre functins r services f a designated COHR Cre. Prpsals in this categry must include infrmatin n the nvelty f the target methd r technlgy and its ptential applicatin t ral health research and data supprting the ptential advantages (e.g., efficiency, cst-saving, time-saving, accuracy, reslutin). If the new methd r technlgy is likely t be included in an existing COHR Cre, the prpsal shuld include a supprt letter frm the respective Cre Directr describing hw the prpsed methdlgy r technlgy wuld be incrprated and managed, including, if apprpriate, a pr frma cst analysis and fee schedule. Pilt prject funds in this categry may be used t purchase instrumentatin and/r licenses necessary t implement and test the prpsed methd(s) r technlgy. Funds nt required fr acquisitin, may be used fr persnnel, supplies, training and ther apprpriate expenses directly applicable and allcable t the new technlgy. Funds may nt Page 2

3 be used t supprt rutine maintenance, repairs r perating csts f the research cre hsting the prpsed methdlgy r technlgy. Prpsals in this categry shuld include an Advisry Cmmittee f internal and at least ne external member with scientific and technlgical expertise t prvide bjective, critical, cnstructive evaluatin and advice regarding the use and effectiveness f the prpsed methdlgy and/r technlgy. PROGRAM ELIGIBILITY The Principal Investigatr (PI) f a pilt prject in any categry must be a full-time faculty member at MUSC. Applicants fr Early Career Pilt Grants may nt have been r currently be PI f a NIH R01, P01 subprject r equivalent, and shuld be within six years f their first full-time faculty appintment at the rank f Instructr r Assistant Prfessr. Applicants fr New Directin r Nvel Methds & Technlgies Pilt Grants may be faculty f any rank at MUSC and shuld have a recrd f accmplishment in their chsen field. PIs f New Directin Pilt Grants may have current NIH r extramural funding; hwever, they must prpse a new research directin that is substantially different frm current r previus line(s) f investigatin. Investigatrs may serve as the PI r c-pi f nly ne prpsal per grant categry (Early Career, New Directin r Nvel Methds & Technlgies) per annual funding cycle. Investigatrs may serve as c-investigatr n multiple applicatins. C-investigatrs are defined as substantial cntributrs wh helped cnceive f the experimental idea, cntributed t the intellectual develpment f the cncept, and/r designed the study r part theref (scientific r technical details). Previus recipients f Early Career and New Directin Pilt Grants are nt eligible t cmpete again fr additinal funding in the same categry. Hwever, an Early Career grantee culd cnceivably apply fr a future New Directin grant and recipients in either categry might develp a future prpsal addressing Nvel Methds & Technlgies. Established investigatrs may serve as a Pilt Prject Mentr fr nly ne Early Career Pilt Grant per annual funding cycle. The Mentr must have recgnitin as an accmplished scientist in his/her chsen field, a strng histry f cmpetitive research supprt, and track recrd f success in training independent investigatrs. The Pilt Prject Mentr may be frm inside r utside MUSC, but cannt be a prir r current supervisr r preceptr. THE APPLICATION PROCESS Letter f Intent Althugh a Letter f Intent is nt required, is nt binding, and des nt enter int the review f a subsequent applicatin, the infrmatin that it cntains allws us t estimate the ptential review wrklad and plan the review. Prspective applicants are asked t submit a Letter f Intent that includes the fllwing infrmatin: Descriptive title f prpsed research. Name, address, and telephne number f the PI. Cmplete listing f the investigative team, their academic titles, primary department and prpsed rle n the prject. Pilt grant categry (Early Career, New Directin r Nvel Methds & Technlgies). The Letter f Intent shuld be submitted by t the COHR Pilt Prject Prgram ffice (westwatc@musc.edu) by April 9, Resubmissin f an Applicatin Applicants will have the pprtunity t submit ne revised applicatin in respnse t review cmments. Revised applicatins shuld be submitted during the fllwing COHR RFA cycle. Investigatrs submitting an amended applicatin will be expected t thrughly address the review critiques using the NIH mdeled Intrductin t Resubmissin Applicatin. The Intrductin must summarize the substantial additins, deletins and changes t the applicatin (1-2 pages). The Page 3

4 Intrductin must als include a respnse t the issues and criticism raised in the Summary Statement. T facilitate the re-review prcess the revisins must be highlighted thrughut the revised applicatin. The substantial scientific changes must be marked in the text f the applicatin by bracketing, indenting, r changing typgraphy. D nt underline r shade the changes. Deleted sectins shuld be described but nt marked as deletins. If the changes are s extensive that essentially all f the text wuld be marked, explain this in the 1-2 page Intrductin. Additinal guidance can be fund in sectin 2.7 Resubmissin Applicatins, f the NIH Applicatin Guide SF424 ( Full Applicatin Applicants shuld submit the applicatin materials thrugh the SCTR website ( by clicking the apprpriate Apply link. All applicatins cnsist f an nline frm and fur PDF uplads. Online Frm (Questins with an * are required fields) PI Name* PI era Cmmns User Name* PI Bisketch*. Please use PHS 398 Bigraphical Sketch Frmat Page (PDF uplad 1: Bisketch) at Fllw the 4-page limit, include a persnal statement and select up t 15 publicatins based n recency, imprtance t the field and/r relevance t the prpsed research. Use the PHS 398 MS Wrd frms, and cnvert t PDF frmat t uplad. Degree* PI Faculty Rank* PI Tenure Track* PI Hme Institutin*, Cllege/Schl, Department*, Center Affiliatin and Divisin within institutin. PI NIH Specialty Cde* PI Phne Number* PI Address* PI Mailing Address* Business Manager Name*, Phne Number*, Address*, Mailing Address* Optinal Cntact Persn Name, Phne Number, Address C-I infrmatin (similar t infrmatin captured fr the PI) Prject infrmatin (e.g. IRB, IACUC). Please nte that funding cannt be released until all applicable institutinal human, animal, and bisafety prtcls (such as IRB, IACUC, IBC), and any ther required regulatry dcuments (such as INDs, IDE, and CITI Training) have been apprved and cpies sent t the COHR Pilt Prject Prgram ffice (harleylu@musc.edu). Investigatrs are strngly encuraged t begin the regulatry apprval prcess prir t submitting the pilt prject applicatin. Child Health Cmpnent* Intellectual Prperty Ptential* Have yu ever applied fr funding r published with any f the C-I(s)?* Prject Title* Grant Categry* Select COBRE- Oral Health PDF Uplad 2: Prject Summary and Relevance 30 lines f text fr Prject Summary, Arial fnt size 11, at least 0.5 margins, PDF nly. The Prject Summary shuld serve as a succinct and accurate descriptin f the prpsed wrk when separated frm the applicatin. State the applicatin's brad, lng-term bjectives and specific aims, making reference t the ral health relatedness f the prject. Describe cncisely the research design and methds fr achieving the stated gals. This sectin shuld be infrmative t thers wrking in the same r related fields and understandable t a scientifically Page 4

5 r technically literate reader. Using n mre than tw r three sentences, describe the Relevance f this research t public health. The Relevance statement shuld be succinct and written using plain language that can be understd by a general, lay audience. PDF Uplad 3: Research Plan 6 page limit (1 page fr Specific Aims, 3 pages fr Research Strategy, 1 page fr Statistical Cnsideratins, and 1 page fr Additinal Review Criteria), Arial fnt size 11, at least 0.5 margins, PDF nly. Revised applicatins must include a 1-2 page Intrductin at the beginning f the Research Plan (see Resubmissin f an Applicatin sectin fr further details). The Specific Aims shuld state cncisely the gals f the prpsed research and summarize the expected utcme(s) including the impact that the results f the prpsed research will exert n the research field(s) invlved. List succinctly the specific bjectives f the research prpsal, e.g., t test a stated hypthesis, slve a specific prblem, challenge an existing paradigm r clinical practice, address a critical barrier t prgress in the field, r develp a new technlgy. The Specific Aims sectin must be limited t ne page. The Research Strategy shuld fllw the standard NIH frmat which includes Significance, Innvatin, and Apprach. Further infrmatin can be fund in Sectin f the PHS Grant Applicatin Guide ( The research prpsal shuld be infrmative enugh fr reviewers t understand the prpsed research withut any supprting dcuments. Applicants shuld include all the required details based n the grant categry and its review criteria within the prpsal withut referring t additinal pages/dcuments. The Research Strategy sectin must be limited t three pages. The Statistical Cnsideratins sectin shuld describe hw the data will be analyzed and used t make inferences regarding the Specific Aims. A justificatin f sample size shuld be included fr animal studies and any aims that include human tissue samples, patients, r healthy vlunteers. Statistical cnsideratins shuld be utlined in a separate sectin (1 page limit) after the Research Strategy sectin (3 page limit). Statistical cnsultatins are available thrugh the SCTR Bistatistics, Epidemilgy and Research Design Prgram ( Investigatrs wishing t use this service shuld submit a request thrugh SCTR SPARC Services Catalg ( Please submit statistical cnsultatin requests by April 9, The Literature Cited sectin shuld be placed at the end f the Research Strategy and is nt included in the page limit. The Additinal Review Criteria sectin shuld include a respnse, if applicable, t the fur pints listed belw. The Additinal Review Criteria sectin must be limited t 1 page and 1 supprt letter. 1. State hw yu plan t utilize the COHR Cres in this prpsal. 2. State hw yu plan t secure future extramural funding and hw yu plan t utilize the COHR Cres in future grant prpsals. Please be sure t state funding agency, mechanism and timeline (ALL Grant Categries). 3. State hw the prpsed research is substantially different frm current r previus lines f research already pursued by yur labratry (New Directin Categry ONLY). 4. Prvide a detailed letter f cmmitment frm the Pilt Prject Mentr describing the mentring arrangement (e.g. frequency f meetings, access t space and/r equipment) and fcal areas (knwledge, techniques r skills) critical t the prject s utcme and the pilt investigatr s career develpment (Early Career Categry ONLY). 5. Prvide a detailed letter f supprt frm the respective COHR Cre Directr describing hw the prpsed methdlgy r technlgy wuld be incrprated int the existing COHR Cre and managed. Include, if apprpriate, a pr frma cst analysis and fee schedule (New Methds & Technlgies Categry ONLY). PDF Uplad 4: Budget and Justificatin Page 5

6 Fr the budget, please use PHS 398 Frm Page 4: Detailed Budget fr Initial Budget Perid in MS Wrd Versin (1 page) at and use cntinuatin pages as needed fr the budget justificatin. Uplad the budget and justificatin as a single PDF file. The COHR reserves the right t reduce requested award amunts. Persnnel Supprt: Faculty salaries are nt an allwable expense. Salary and fringe benefits are allwed fr technical supprt, such as: Pstdctral Fellws, Research Specialists and Study Crdinatrs. Nn-persnnel Research Expenses: Allwable expenses include research supplies, animal purchase and per diem, institutinal cre service fees, research subject cmpensatin and transprtatin, and data analysis/statistical supprt. All expenses must be directly related t the prpsed research. Funds fr research equipment and/r prfessinal travel may be requested nly with specific justificatin describing exceptinal circumstances with dcumentatin f critical need and absence f feasible alternatives. Unallwable Csts: General ffice supplies, cmputers and laptps, membership dues and fees, publicatin csts, subscriptin csts, mailing csts, and rent. Faculty salaries are nt an allwable expense. Facilities and Administrative Csts: Facilities and administrative csts, als knwn as indirect csts, are nt permitted. APPLICATION REVIEW CRITERIA AND PROCESS Overview Each applicatin will be assigned t at least tw reviewers with apprpriate expertise and withut cnflict f interest, wh are faculty members at MUSC r utside academic institutins. Reviewers are instructed t evaluate the quality f the research (significance, investigatr(s), innvatin, apprach, envirnment) using the 9-pint NIH rating scale (1= Exceptinal t 9= Pr). The reviewers will address the Additinal Review Cnsideratins listed belw fr each applicatin as applicable, and will generate an Overall Impact Scre based n the quality f the research and the Additinal Review Cnsideratins. The COHR Steering Cmmittee will priritize the applicatins based n the verall impact scre, Summary Statement, and als n the prgrammatic needs f the COHR. Funding recmmendatins will be frwarded t the COHR External Advisry Cmmittee fr final funding decisins. Additinal Review Cnsideratins fr ALL Grant Categries Des the prpsal address an imprtant ral health-related prblem and, if successful, will the results have a substantial impact n ral and cranifacial health? Des the prpsal utilize ne r mre COHR Cres? Is the prject fcused, feasible, and achievable, and des it have a high ptential t secure future extramural funding that will utilize ne r mre COHR Cres? Des the prpsal stimulate cllabratins with COHR members that therwise might nt have taken place? Fr clinical and animal studies, d applicatins include a statistical pwer analysis? Des the prpsal describe statistical methds required fr analysis f study data? Althugh applicatins will primarily be pilt prjects, they must be adequately pwered t prvide meaningful infrmatin abut the feasibility and size fr planned future extramural grant applicatins. Additinal Review Cnsideratins fr Early Career Pilt Grants Des the prpsal include a supprt letter describing a clearly defined mentrship plan with a senir/established investigatr? Will the investigatr receive adequate supervisin and mentring? Des the prpsal describe a plan fr achieving research independence and ptential t lead t extramural independent funding? Has the investigatr defined a need fr funding t supprt the prpsed directin f research? Additinal Review Cnsideratins fr New Directin Pilt Grants Page 6

7 Des the prpsed research incrprate ideas and aims that are substantially different frm thse already being pursued by the investigatr? Has the investigatr defined a need fr funding t supprt the prpsed directin f research? Additinal Review Cnsideratins fr Nvel Methds & Technlgies Pilt Grants What is the likelihd that the new methd r technlgy will directly enhance, advance r replace ne r mre functins r services within a designated COHR Cre? Des the nvel methd/technlgy have ptential value t multiple investigatrs, if s, hw many ptential users? Des the nvel methd/technlgy have the ptential t supprt extramurally funded research prjects? Des the applicatin include a supprt letter frm a COHR Cre Directr describing hw the prpsed methd/technlgy wuld be incrprated int the existing COHR Cre and managed? Page 7