New Investigator RESEARCH GRANT

Page 2 f 13 CONTENTS Grant Prgram Descriptin... 3 Eligibility... 4 Funding Infrmatin... 5 Grant Recipient Respnsibilities... 6 Selectin Criteria... 7 Itemized Applicatin Instructins... 10 2

Page 3 f 13 Grant Prgram Descriptin The ASHP Research and Educatin Fundatin (ASHP Fundatin) is ffering a research grant prgram that will supprt practice-based research, cnducted by pharmacist new investigatrs and related t advancing pharmacy practice. The primary gal f the prgram is t supprt quality research t advance pharmacy practice. A secndary gal is t develp new investigatrs research skills while fstering develpment f mentring relatinships with mre experienced senir investigatrs. The prpsed practice-based research must be aligned with: The visin, missin and critical issues f the ASHP Fundatin; The set f assumptins, beliefs and recmmendatins fr advancing pharmacy practice frm the Nvember 2010 ASHP/ASHP Fundatin Pharmacy Practice Mdel Initiative (PPMI) Summit r the recmmendatins frm the March 2014 ASHP Ambulatry PPMI Cnference and Summit. Submissin f studies that evaluate pharmacy practice mdels in hspitals, health systems, and ther ambulatry settings is invited. Practice-based research affects a wide range f practice mdel tpics; including the utilizatin f technlgy, rle delineatin changes fr the pharmacists and nn-pharmacists, r enhancing patient care pprtunities fr pharmacists. Applicants shuld utilize the recmmendatins frm the PPMI Summit and the Ambulatry PPMI Summit in the PPMI Web Resurce Center t identify relevant tpics fr this grant prgram. Applicatins fr this research grant prgram are required t include: Measurable bjectives that relate t practice-based research that fcuses n advancing pharmacy practice mdels; Rigrus research methds that supprt the study bjectives; Mentring activities between a senir investigatr/advisr and the new investigatr; Descriptin f the impact that the results f the prject will have n advancing pharmacy practice mdels; Descriptin f the ptential t generalize findings t ther health care facilities; Interprfessinal cllabratin; and Organized plan fr prudent use f grant funds. Preference will be given t research prjects with the ptential t yield strng scientific evidence that can be used t advance pharmacy practice mdels. ASHP Fundatin Visin As the philanthrpic arm f ASHP, ur visin is that: Patient utcmes imprve because f the leadership and clinical skills f pharmacists, as vital members f the health care team, accuntable fr safe and effective medicatin use. 3

Page 4 f 13 Our Missin The missin f the ASHP Fundatin is t imprve the health and well-being f patients in health systems thrugh apprpriate, safe and effective medicatin use. ASHP Fundatin Strategic Pririties 1. Facilitate and strngly supprt the pharmacy prfessin in advancing pharmacy practice mdels that fster pharmacists leadership and accuntability fr patient utcmes. 2. Create demand fr new mdels f pharmacy practice that leverage the expertise and unique abilities f pharmacists. 3. Drive the advancement f the technical, human and leadership cmpetencies f pharmacists and pharmacy staff in cmplex and rapidly changing rganizatins. 4. Ensure the lng-term financial sustainability f the ASHP Fundatin. The strategic pririties f the ASHP Fundatin are clsely aligned with the ASHP strategic plan. ASHP represents pharmacists wh serve as patient care prviders in acute and ambulatry settings. The rganizatin s mre than 40,000 members include pharmacists, student pharmacists and pharmacy technicians. Fr ver 70 years, ASHP has been n the frefrnt f effrts t imprve medicatin use and enhance patient safety. The ASHP Fundatin pursues its missin and strategic pririties thrugh prvisin f awards, research grants, educatinal prgrams, and practice tls. The ASHP Fundatin has a lng track recrd f administering research grant, educatin and practitiner recgnitin prgrams that use stringent external review prcesses t select prgram recipients and participants. Visit ur website t learn mre abut the ASHP Fundatin. Eligibility The prpsed research must fcus n the advancement f pharmacy practice mdels and be cnducted by a pharmacist new investigatr. The principal investigatr must be a new researcher within five (5) years f cmpletin f his/her terminal degree r pstgraduate training r have prfessinal experience greater than five years and n mre than tw (2) externally funded research prjects as a principal investigatr. The principal investigatr must be a licensed pharmacist and multidisciplinary research teams are strngly encuraged. A senir investigatr must participate n the research team as a mentr/advisr. In the applicatin prcess and grant prgress reprts, evidence must be included regarding the supprt and invlvement f the senir investigatr. Fr this grant prgram, the senir investigatr assumes respnsibility fr cmpliance with all requirements f the grant prgram. The senir investigatr des nt have t be a pharmacist. Applicants are strngly encuraged t include an individual with a strng research track recrd as the senir investigatr. Histry f publicatin f riginal research in peer-reviewed bimedical jurnals and receipt f extramural grant funding will be used t evaluate the senir investigatr s research track recrd. A bistatistician shuld be included as a member f the research team. Strng cnsideratin shuld be given t allcating a prtin f the budget t supprt bistatistics cnsultatin. The prpsed research must be submitted t an institutinal review bard (IRB) fr apprval. Evidence f IRB apprval must be prvided t the ASHP Fundatin upn acceptance f the grant award. Grant funds will nt be disbursed until evidence f IRB apprval, r exemptin frm review, has been received. 4

Page 5 f 13 Individuals wh previusly served as a principal investigatr n any ASHP Fundatin grant are eligible t apply if all wrk, including jurnal submissin f the study findings, n the previusly funded research is cmplete. If a tie scre ccurs during the grant review prcess, the grant will be awarded t the applicant(s) wh has/have nt received a grant frm the ASHP Fundatin previusly. Nt-fr-prfit rganizatins, fr-prfit entities, and gvernment agencies are eligible t apply t this prgram. If a fr-prfit entity r gvernment agency is a grant recipient, the mnetary award prvided by the ASHP Fundatin must be received and managed by a 501(c)3 nt-fr-prfit rganizatin. Applicant rganizatins must be in the United States f America t be eligible fr the grant. Members f the ASHP and ASHP Fundatin bards f directrs as well as ASHP and ASHP Fundatin staff are nt eligible t serve as a member f the investigatr team fr this research grant prgram. The research must cmply with the NIH Plicy and Guidelines n the Inclusin f Wmen and Minrities as Subjects in Clinical Research that was amended in Octber 2001. The research must cmply with the NIH Plicy and Guidelines On the Inclusin f Children As Participants in Research Invlving Human Subjects. The study timeline shuld nt exceed 24 mnths frm prject initiatin. Senir investigatrs cannt apply fr mre than ne grant in an applicatin cycle. Funding Infrmatin Tw (2) $20,000 grants will be awarded. Grants will be awarded t pharmacist new investigatrs t prvide funding fr specific practice-based research related t advancing pharmacy practice mdels and are nt intended fr lng-term supprt f research prgrams. Facilities and administrative cst rates that d nt exceed 8% f the ttal requested budget are allwed. Funds may nt be applied t: Resident salaries and/r benefits; Onging general perating expenses and/r existing deficits; Purchase f permanent equipment, facilities, r sftware, r ther capital csts; Endwment cntributins; and Stipends r lans. Funding is generally available fr: Salary supprt fr study persnnel including bistatisticians; Institutinal review bard fees; Cnsumable supplies and services; Travel essential t the cnduct f the prpsed prject; Patient expenses/reimbursement; Travel t present prject findings in the range f $1,000 t $1,500 per prject; and Facilities and administrative cst rates that d nt exceed 8% f the ttal direct csts. 5

Page 6 f 13 Grants will be awarded t individuals and the funds will be disbursed directly t the spnsring institutin fr administratin. Grant Recipient Respnsibilities The grant perid f activity will begin upn ntice f grant award by the ASHP Fundatin and will expire 24 mnths after this initial ntificatin. Fllwing initial disbursement f funds, the grantees must submit Quarterly Research Reprts t the ASHP Fundatin that address: Prgress tward cmpletin f activities included n the study timeline fr the quarter in questin; Any prtcl mdificatins and dcumentatin f IRB review and apprval f such mdificatins; and A summary f all adverse events assciated with executin f the study during the quarter in questin and dcumentatin f IRB review f such adverse events. Within 60 days f study cmpletin, the grantees must submit a Final Research Reprt t the ASHP Fundatin. This reprt must include: A summary f the study results including statistical analysis, if applicable; Preliminary cnclusins; A summary f all adverse events assciated with executin f the study and dcumentatin f IRB review f such adverse events; A summary f all prtcl mdificatins and dcumentatin f IRB review and apprval f such mdificatins; and Specific plans fr presentatin and publicatin f the study findings. Within 60 days f submissin f the Final Research Reprt, the grantees must submit a systemgenerated Final Financial Reprt. This reprt must include a cmplete and full accunting f the expenditure f ASHP Fundatin funds related t the executin f the study. Any unused funds must be returned t the ASHP Fundatin by the grantees within 120 days f submissin f the Final Financial Reprt. If, fr any reasn, the grantees d nt cmplete the prject, the senir investigatr must infrm the ASHP Fundatin in writing within 30 days f study terminatin. Within 60 days f study terminatin, the grantees are required t cmplete the Final Research Reprt and a system-generated Final Financial Reprt and return any unused funds t the ASHP Fundatin as described abve. The grantees may request ne grant extensin. Only ne extensin will be granted fr any study. The prject must be cmpleted and all ther requirements f the grant fulfilled by the end f the extensin perid. 6

Page 7 f 13 If the findings f the abve named study are presented at a natinal pharmacy meeting, ASHP retains the right f first refusal fr presentatin f the study and its findings at an ASHP meeting. If the study and its findings are presented at a medical r multidisciplinary meeting, the grantee shuld apply t als present the study and its findings at the ASHP Midyear Clinical Meeting that fllws presentatin at the medical r multidisciplinary meeting. Travel t the ASHP Midyear Clinical Meeting t present study findings shuld be supprted thrugh grant r institutinal funds. The ASHP Fundatin requires submissin f study results t a peer-reviewed scientific jurnal within 6 mnths f study cmpletin. If the study results are submitted t a pharmacy jurnal, the American Jurnal f Health-System Pharmacy retains the right f first refusal fr publicatin. The ASHP Fundatin shuld be ntified by the principal investigatrs when articles cntaining the study findings are published. All presentatins, publicatins, and ther cmmunicatins regarding this study must include the fllwing acknwledgement: This study was funded (r partially funded) by a research grant frm the ASHP Research and Educatin Fundatin. By accepting this award, the grantee will undertake all reasnable effrts t cmplete the study and take respnsibility fr fulfilling the terms described within the award letter. The recipient institutin is respnsible fr the actins f its emplyees and ther research cllabratrs, including third parties, invlved in the prpsed research. The recipient institutin will inquire int and, if necessary, investigate and reslve prmptly and fairly all instances f alleged r apparent research miscnduct related t this ASHP Fundatin-spnsred research in accrdance with federal regulatins n research miscnduct (see 42 CFR part 93, Public Health Service Plicies n Research Miscnduct. ) and the U.S. Department f Health and Human Services Grants Plicy Statement (see http://www.ahrq.gv/fund/hhsplicy.htm). The recipient institutin must reprt prmptly t the ASHP Fundatin any incident f alleged r apparent research miscnduct invlving ASHP Fundatin-spnsred research that it judges as warranting investigatin and must advise the ASHP Fundatin f any decisin t initiate an investigatin. The recipient institutin must als ntify the ASHP Fundatin if it intends t clse a case at the inquiry r investigatin stage based n an admissin f respnsibility, settlement, r fr any ther reasn. If a miscnduct investigatin has been initiated, the recipient institutin must take any necessary steps, in additin t its nrmal and nging respnsibilities under the grant, t prtect human subjects, prtect the scientific integrity f the prject, prvide reprts t the ASHP Fundatin, and ensure the prper expenditure f funds and cntinuatin f the prject during the investigatin, if apprpriate. If the recipient finds research miscnduct by anyne wrking n ASHP Fundatin -supprted research, whether at its rganizatin r at a third-party rganizatin, the recipient institutin must assess the effect f that finding n the ability t cntinue that prject, as riginally apprved, and must prmptly request ASHP Fundatin prir apprval f any intended change f PI r ther key persnnel. In additin, the ASHP Fundatin may withdraw apprval f the principal investigatr r ther key persnnel, disallw csts assciated with the invalid r unreliable research, suspend r terminate, in whle r in part, the grant award. 7

Page 8 f 13 Full Applicatin Selectin Criteria The full applicatins fr the grant will be evaluated using the selectin criteria listed belw. Overall Funding Pririty Scre = (1-9) Using the fllwing rating scale, reviewers will prvide an verall pririty scre t reflect their verall assessment f the likelihd fr the prject t exert a sustained, pwerful influence n the research field(s) invlved. This scre represents the reviewers verall assessment f the applicatin and is nt based nly n the criteria-based scre described belw. Criteria Based Scre = (0-100) Using the fllwing criteria, reviewers shuld prvide an verall scre t reflect their assessment f the study: ratinale; bjectives; significance and innvatin; investigatrs and envirnment; study methds; and scpe and timeline. Specific Aims and Hypthesis (20 pints maximum): Are the study bjectives cnsistent with the specific grant prgram fcus and the strategic pririties f the ASHP Research and Educatin Fundatin? Is the research questin clear and well-defined? Are the verall bjectives riginal and innvative? Are the bjectives measurable? Is the number f bjectives reasnable based n available funding? Ratinale and Significance (10 pints maximum): D the investigatrs clearly explain why this study shuld be undertaken? Des this study address an imprtant prblem? Is there an adequate review f the relevant literature included in the prpsal? 8

Page 9 f 13 Des the literature review demnstrate that the investigatr understands the field and has a balanced and adequate knwledge f it? D the investigatrs identify gaps in the existing evidence base and prpse hw the prpsed study will fill thse gaps? If the aims f the applicatin are achieved, hw will scientific knwledge r clinical practice be advanced? D the investigatrs identify the next lgical stages f research beynd the current applicatin? Innvatin (10 pints maximum): Is there a justificatin within the backgrund sectin abut the research field that led t the prpsed study? Is the prject riginal and innvative? Fr example, des the prject challenge existing paradigms r clinical practice r address an innvative hypthesis r critical barrier t prgress in the field? Des the prject develp r emply nvel cncepts, appraches r methdlgies, tls, r technlgies fr this area? If the study is nt innvative but is essential t mve the field frward, des the applicant discuss this in the prpsal? What will be the effect f this study n the cncepts, methds, technlgies, treatments, services, r preventative interventins that drive this field? Investigatrs and Envirnment (15 pint maximum): Are the principal investigatr and ther key persnnel apprpriately trained and well suited t carry ut this wrk? Is the prpsed wrk apprpriate t the experience level f the principal investigatr and the ther members f the research team, including the senir investigatr, if applicable? D the principal investigatr and the research team bring cmplementary and integrated expertise t the prject? Is the research team interdisciplinary in its cmpsitin? Is a bistatistician included n the research team? Is there evidence f a cmmitment t cllabratin within the research team? Des the scientific envirnment in which the wrk will be dne cntribute t the prbability f success? Des the prpsed study benefit frm unique features f the scientific envirnment, r subject ppulatin, r emply useful cllabrative arrangements? Is there evidence f institutinal supprt? Apprach (40 pints maximum): Are the cnceptual r clinical framewrk, design, methds, and analyses adequately develped, wellintegrated, well-reasned, and apprpriate t the aims f the prject? D the investigatrs prpse clear and detailed study methds? Will the methds enable the researcher t address the stated bjectives and hypthesis? D the prcedures t be fllwed include, when applicable: apprpriate study design; sampling techniques and a descriptin f the ppulatin frm which the sample will be recruited; cntrls; prcedures fr cllectin, strage and quality cntrl f data fr the majr utcme variable, secndary utcmes, and ther cvariates; assurance f availability f subjects and/r facilities t be used; feasibility f plans fr recruitment and retentin f subjects; and plans fr data analysis including bistatistics supprt? Are methds prblems anticipated and alternative appraches prpsed? Can the prpsed study methds be replicated and generalized? Scpe and Timeline (5 pints maximum): D the investigatrs justify that the prpsed timeline is realistic? Is there evidence the study can be cmpleted in the prpsed time perid? D the investigatrs present infrmatin t supprt the feasibility f the study (e.g., pilt data)? Will sufficient patients/subjects be available fr cmpletin f the prject within the prpsed time perid? 9

Page 10 f 13 Additinal Review Cnsideratins: In the written review and during the review call, reviewers will als address prtectin f human subjects, inclusiveness, patient privacy and safety prtectins, and budget/budget justificatin. Prtectin f Human Subjects frm Research Risk: D the investigatrs adequately address human subjects prtectins? Inclusiveness: Des the research plan address gender, racial and ethnic minrity balance? Privacy and Security Prtectins fr Patients: D the investigatrs adequately address patient privacy and safety issues? Budget: Are the prpsed budget and budget justificatins reasnable, and is the requested perid f supprt apprpriate in relatin t the prpsed research? ITEMIZED APPLICATION INSTRUCTIONS Prject The study must relate directly t advancing pharmacy practice mdels in hspitals, health systems, r ther ambulatry settings as described in the Grant Prgram Descriptin sectin. Principal Investigatr Self-explanatry. Please nte: Members f the ASHP and ASHP Fundatin Bard f Directrs, as well as ASHP and ASHP Fundatin staff are nt eligible t serve as a member f the investigatr team fr this research grant prgram. Self-explanatry, if applicable. Degree(s) Psitin title. Institutin/Organizatin name. Physical mailing address at place f emplyment. Business telephne number at place f emplyment. Email address that is mst cmmnly used fr frequent cmmunicatin. Percent effrt is the ttal percentage f the investigatr s time that he/she will cmmit t this study. Fr example, if an investigatr wrks 50 hurs per week and expects t cmmit 5 hurs per week t the study, his/her percent effrt wuld be 10%. Senir Investigatr Self-explanatry. Please nte: Members f the ASHP and ASHP Fundatin Bard f Directrs, as well as ASHP and ASHP Fundatin staff are nt eligible t serve as a member f the investigatr team fr this research grant prgram. Self-explanatry, if applicable. 10

Page 11 f 13 Degree(s) Psitin title. Institutin/Organizatin name. Physical mailing address at place f emplyment. Business telephne number at place f emplyment. Email address that is mst cmmnly used fr frequent cmmunicatin. Percent effrt is the ttal percentage f the investigatr s time that he/she will cmmit t this study. Fr example, if an investigatr wrks 50 hurs per week and expects t cmmit 5 hurs per week t the study, his/her percent effrt wuld be 10%. Spnsring Institutin and Grant Officer Nt-fr-prfit rganizatins, fr-prfit entities, and gvernment agencies are eligible t apply t this prgram. If a fr-prfit entity r gvernment agency is a grant recipient, the mnetary award prvided by the ASHP Fundatin must be received and managed by a 501(c)3 nt-fr-prfit rganizatin. The institutin must be in the United States f America t be eligible fr the grant. The spnsring institutin is that lcatin at which the research will be cnducted. Grant checks will be made payable t the institutin name listed. Self-explanatry. List the grant fficer at the spnsring institutin wh will be respnsible fr mnitring f grant fund use. Institutins with grants management divisins are required t submit the grant applicatin t the institutinal grants management divisin fr review and sign-ff prir t submissin t the ASHP Fundatin. Fr institutins that d nt have internal grants management divisins, the institutin must identify an apprpriate entity (e.g., related healthcare fundatin) t receive the funds and mnitr their use. The grant fficer cannt be a member f the investigatr team. The grant fficer cannt be a departmental supprt staff member (e.g., administrative assistant.) Title f the grant fficer must directly reflect an apprpriate individual t receive the funds and mnitr their use. Physical mailing address f the grant fficer that all grant crrespndence will be sent t. Business telephne number f grant fficer. Email address that is mst cmmnly used fr frequent cmmunicatin. Other Investigatrs All ther prfessinals engaged in prject fr whm salary supprt is NOT being requested must be named here with his/her credentials, institutin name and department/divisin, email address, and his/her percent effrt dedicated t this study. If institutinal in-kind cntributin f time fr these members f the investigatr team will be required fr cmpletin f the prpsed research, a supprt letter that cnfirms this institutinal supprt shuld be included. Self-Explanatry. Detailed Budget (a) PERSONNEL All persnnel fr whm salary supprt is requested must be named in this sectin. Salary supprt is available nly fr study persnnel (e.g., technical persnnel; clerical persnnel; and ther prfessinal 11

Page 12 f 13 persnnel.) Resident salaries and fringe benefits are nt allwed under this grant prgram. Strng cnsideratin shuld be given t allcating a prtin f the budget t supprt bistatistics cnsultatin. In the persnnel budget justificatin sectin, prvide a detailed justificatin that describes each individual s rle. The budget justificatin shuld crrespnd directly t the prject plan. (b) CONSUMABLE SUPPLIES All cnsumable supplies must be itemized as t descriptin, number, cst per unit, and ttal cst. If exact csts are nt knwn, estimates must be prvided. Prvide a detailed justificatin fr each budget item. The budget justificatin shuld crrespnd directly t the prject plan. (c) TRAVEL Only travel csts essential t the cnduct f the prject are eligible fr funding. Travel t present prject findings is acceptable in the range f $1,000 t $1,500 per prject. In the travel budget justificatin, prvide a detailed justificatin fr each budget item. All travel t present study findings shuld be supprted thrugh grant r institutinal funds. Estimated csts fr meeting registratin fees, airfare, ldging, meals, and grund transprtatin must be prvided. (d) OTHER EXPENSES All ther expenses nt already specified must be itemized and justified in relatin t the prject. Permanent equipment, facility cnstructin r renvatin, and sftware are nt eligible fr funding. Prvide a detailed justificatin fr each budget item. The budget justificatin shuld crrespnd directly t the prject plan. (e) FACILITIES AND ADMINISTRATIVE COSTS Requests fr supprt fr facilities and administrative csts rates cannt exceed 8% f the direct csts. TOTAL budget shuld be the same as Item I (d). Supprting Dcuments Required (a) UPLOADS Each f the fllwing nine headings must appear in the stipulated rder: Research Plan Cmpnents Descriptin f prpsed research plan n n mre than ten (10) pages (using 11 pint fnt r larger, 8.5 x 11 inches paper, 1-inch margins, single spacing and single-sided pages) with numbered pages under the fllwing headings: 1. Abstract f prpsal (limit t ne page with a fcus n bjectives and methds); 2. Specific Aims and Hypthesis 3. Ratinale and Significance 4. Innvatin 5. Investigatrs and Envirnment 12

Page 13 f 13 6. Apprach detailed study prcedures; pwer calculatin, if applicable; plans fr data analysis; and prcedures fr recruitment, retentin, and prtectin f subjects, if applicable 7. Human Subjects/Inclusiveness/Privacy 8. Scpe and Timeline 9. References Including the abstract and references, the narrative f the prject plan may nt exceed ten (10) pages (using 11 pint fnt r larger, 8.5 x 11 inch paper, 1 inch margins, single spacing and single sided pages). Applicants shuld strictly cmply with fnt size, paper size, spacing and page limit requirements. (b) BIOGRAPHICAL DATA Prvide a bigraphical sketch fr each investigatr. Bigraphical sketches must be limited t 4 pages and must be submitted in the frmat prvided in the PHS 398 frm frm the U.S. Department f Health and Human Services. (See http://www.grants.nih.gv/grants/funding/phs398/bisketchsample.dc) (c) CERTIFICATION AND ACCEPTANCE This certificatin must be signed by the principal investigatr, senir investigatr, and the grant fficer (named in Item III). 13