AOTF Interventin Research Grant 2018-2019 Request Fr Applicatin The AOTF Interventin Research Grant (IRG) is targeted t principal investigatrs wh d nt currently have substantial extramural research awards as an independent principal investigatr (e.g., NIH, R01, PCORI, Research Prgram Prject Grant, Veterans Administratin Merit Award, and Field-Initiated Prject). Typically, the principal investigatr (PI) will have a funding histry assciated with early stage, emerging, r early midcareer investigatrs that may include small research grants and training-related r mentred career awards. The PI must als have a cmmitment frm an experienced research mentr wh has an established recrd f substantial extramural grant funding, peer-reviewed publicatins, and supervisin and mentring f researchers. Cntact AOTF (research@atf.rg) if yu have any questins. I. Abut the 2018-2019 Funding Pririties fr Interventin Research II. Abut the Appraches: Pilt/Feasibility/Planning Grant Descriptins III. Abut the Available Awards IV. Abut the Eligibility Criteria fr Investigatrs V. Abut the Prcess and Timeline fr 2018-2019 Applicatins VI. Abut the Cmpnents f the 2018-2019 Letter f Intent and Applicatin VII. Abut the Key Review Criteria fr 2018-2019 Applicatins Grant Eligibility Frm and Letter f Intent will pen July 16, 2018. I. ABOUT THE 2018-2019 FUNDING PRIORITIES FOR INTERVENTION RESEARCH A. What are the research pririties fr the 2018-2019 funding cycle? The AOTF Research Pririties were used t establish the funding pririties. The AOTF Research Pririties: Health behavirs t prevent and manage chrnic cnditins Functinal cgnitin Safety and injury preventin in hme, clinical and cmmunity settings Technlgy and envirnmental supprts in hme and cmmunity Develpment and transitins fr individuals and families Emtinal and physilgical influences Family and caregiver needs Health care experience: access, care crdinatin, utilizatin B. What are the bjectives f the AOTF Interventin Research Grant? Lay the necessary grundwrk fr larger studies t evaluate the effectiveness f ccupatinal therapy interventins n ccupatin, participatin, and health. Align with future funding pririties and intended surces f funding. Develp interventins that are client-centered, ccupatin-based, thery-driven, and manualized. Lead t efficacy (research under tightly cntrlled cnditins) r effectiveness (research under real-wrld cnditins) trials. Cultivate interdisciplinary research teams and partner with cmmunities. Include underserved and diverse ppulatins in research.
II. ABOUT THE APPROACHES: PILOT/FEASIBILITY/PLANNING GRANT DESCRIPTIONS A. Appraches that lay the necessary grundwrk fr larger interventin studies include: Pilt studies A Pilt Study is a versin f the main study that is run in miniature t test whether the cmpnents f the main study can all wrk tgether. It is fcused n the prcesses f the main study, fr example t ensure recruitment, randmisatin, treatment, and fllw-up assessments all run smthly. It will therefre resemble the main study in many respects. In sme cases this will be the first phase f the substantive study and data frm the pilt phase may cntribute t the final analysis; this can be referred t as an internal pilt. Alternatively at the end f the pilt study the data may be analysed and set aside, a s-called external pilt. (p. 5) Pilt studies are characterized by: rigrus methdlgical cmpnents like sample size estimatin, randmizatin and cntrl grup selectin (p. 5) an explicit purpse (e.g., t test a new prcedure in preparatin fr a clinical trial ) and the criteria which lead t further studies being abandned. (p. 6) reprting f results are interpreted with cautin (p. 6) r as incnclusive, with the intentin f cnducting a further, larger study (p. 5) results that prvide infrmatin t enable a sample size calculatin in a subsequent main study. (p. 6) Feasibility studies Feasibility Studies are pieces f research dne befre a main study. They are used t estimate imprtant parameters that are needed t design the main study. Fr instance: standard deviatin f the utcme measure, which is needed in sme cases t estimate sample size, willingness f participants t be randmised, willingness f clinicians t recruit participants, number f eligible patients, characteristics f the prpsed utcme measure and in sme cases feasibility studies might invlve designing a suitable utcme measure, fllw-up rates, respnse rates t questinnaires, adherence/cmpliance rates, ICCs in cluster trials, etc. Feasibility studies fr randmised cntrlled trials may nt themselves be randmised. Crucially, feasibility studies d nt evaluate the utcme f interest; that is left t the main study..if a feasibility study is a small randmised cntrlled trial, it need nt have a primary utcme and the usual srt f pwer calculatin is nt nrmally undertaken. Instead the sample size shuld be adequate t estimate the critical parameters (e.g. recruitment rate) t the necessary degree f precisin. (p. 5) In general, feasibility studies are cnducted with mre flexible methdlgy cmpared t thse labeled 'pilt'. Fr example the term 'feasibility' has been used fr large scale studies such as a screening prgramme applied at a ppulatin level t determine the initial feasibility f the prgramme. (p. 5) AOTF Interventin Research Grant RFA Page 2 f 6
Arain, M., Campbell, M. J., Cper, C. L., & Lancaster, G. A. (2010). What is a pilt r feasibility study? A review f current practice and editrial plicy. BMC medical research methdlgy, 10(1), http://www.ncbi.nlm.nih.gv/pmc/articles/pmc2912920/ Interventin research planning grants An interventin research planning grant allws a new cmmunity (typically multi-disciplinary) f experienced investigatrs t frm and share knwledge and ideas arund a shared prblem prir t attempting t undertake cllabrative interventin research. The planning grant perid allws the PI t determine wh is cmmitted t wrking tgether in a true cllabrative spirit. The prduct f the planning grant shuld be a detailed plan fr ging frward with clearly identified gals fr interventin research, a wrk agenda with defined rles fr participants, and a plan fr btaining the needed resurces t allw the prgram t g frward. What are the key elements fr success in a planning grant? A driver the ne persn wh has the passin and visin and takes a leadership rle A team cmmitted t wrking tgether with a deep appreciatin fr why traditinal appraches will nt slve the prblem. Duratin lng enugh fr true planning and cllabratin but shrt enugh t drive a prduct. A structure that allws fr bth a fcused wrking grup and casting a wide net. An pprtunity t invlve individuals acrss the career span but especially junir peple wh will then internalize a new mdel fr successful research. A prblem that cannt be slved withut a nvel apprach calling n cmbined expertise A cmmitment t develping a cmmn currency r a shared language this means develping a respect fr ther kinds f knwledge and fr recgnizing why a particular, dgmatic apprach will nt succeed. This takes time and sme discmfrt. An atmsphere f trust individuals must be cmfrtable pushing ne anther. A prject that has bth practical utcmes while cntributing the further develpment f thery. A planning grant shuld include gals t: Yield a prgram f interventin research with real grwth ptential Yield peratinal success s a cmpnent f the applicatin shuld include a plan fr hw the prgram f interventin research identified during the planning prcess wuld be supprted by identifying pertinent RFAs. Demnstrate why ccupatinal therapy is central t the interventin research prgram and its likelihd f success. Prvide a true training cmpnent t strengthen capacity fr interventin research. James S. McDnnell Fundatin, persnal cmmunicatin http://www.jsmf.rg/abut/s/preface-gauthier.pdf III. ABOUT THE AVAILABLE AWARDS FOR THIS INTERVENTION RESEARCH INITIATIVE One year nn-renewable prpsals fr up t $50K (including indirect csts) will be cnsidered. Indirect expenses will be funded up t the level f 10%. Funds will be released in 2018 n a payment schedule identified by AOTF. The grant cycle will begin n July 1 pending IRB receipt by AOTF. AOTF Interventin Research Grant RFA Page 3 f 6
IV. ABOUT THE ELIGIBILITY CRITERIA FOR INVESTIGATORS A. What are the eligibility criteria fr the principal investigatr (PI)? General Persnal Criteria The PI has a terminal research degree r has an OTD with advanced research training (such as cmpletin f a research fellwship). The PI is emplyed by a U.S. dmestic, public r private, nn-prfit rganizatin/institutin that is eligible t receive Fundatin research grants and will prvide assurance f its accuntability and supprt fr the prject. The PI is a U.S. citizen r nn-citizen natinal f the United States OR admitted fr permanent residence OR applied fr permanent residence. (Fr nn-citizens, the applicant rganizatin must have plicies in place t determine whether residence status r visa status will allw cmpletin f the research.) The PI is a credentialed ccupatinal therapist with a faculty appintment r an equivalent research psitin OR a nn-ot investigatr with a primary academic appintment in an ccupatinal therapy department. Research and Prpsed Prject Criteria The PI has a track recrd f achievements and career gals related t the prpsed prject that includes peer-reviewed publicatins. The PI des nt currently have any substantial extramural research awards (e.g. RO1, PCORI, Research Prgram Prject Grant, Veterans Administratin Merit Award, Field-Initiated Prject). Typically, the PI will have a funding histry assciated with early stage, emerging, r early midcareer investigatrs that may include small research grants and training-related r mentred career awards. The PI has a cmmitment frm an experienced research mentr wh has an established recrd f substantial extramural grant funding, peer-reviewed publicatins and supervisin and research mentring experience. The PI des nt have any cnflicts f interest. The PI is nt: An AOTF r AOTA bard r staff member An AOTF Scientific Advisry Cuncil member A bard r staff member f an IRG spnsr V. ABOUT THE PROCESS AND TIMELINE FOR 2017-2018 APPLICATIONS A. What is the prcess fr submitting an applicatin fr 2017-2018 Interventin Research funding? Applying fr the grant invlves several steps: The principal investigatr reviews the eligibility criteria and cmpletes the nline Grant Eligibility Frm. The nline site fr the AOTF Interventin Research Grant pens July 16, 2018. If the principal investigatr meets all eligibility criteria n the nline Grant Eligibility Frm, immediate access will be given t the Letter f Intent (LOI). The LOI must be submitted by August 24, 2018, 11:59 CDT. The LOI is reviewed by AOTF. If the PI meets all eligibility criteria and the LOI is accepted by AOTF, applicants will be prvided with a link t the applicatin. Principal investigatrs wh are granted permissin t submit an applicatin will be ntified by September 21, 2018. Applicatin deadline: Nvember 13, 2018, 11:59 CDT. Applicants are respnsible fr all deadlines. Deadline extensins will NOT be granted. AOTF Interventin Research Grant RFA Page 4 f 6
B. What is the timeline fr the 2018-2019 Interventin Research Grant prject? July 2018 Review the research pririties, bjectives, appraches, and eligibility criteria. Begin develping the initial framewrk fr a Letter f Intent and Applicatin using infrmatin and instructins n the AOTF website. Cntact AOTF if yu have questins regarding the Interventin Research Grant prgram. (AOTF Scientific Prgrams Officer, research@atf.rg). July 16, 2018 -- Online submissin site fr Letter f Intent pens. August 2018 August 24, 2018 -- Letter f Intent deadline 11:59 p.m. CDT. September 2018 September 21, 2018 -- Invitatins t submit an Applicatin are extended t principal investigatrs wh meet all eligibility criteria and have submitted an LOI that is accepted by AOTF. September 21, 2018 Online Applicatin site pens. Begin Applicatin. Nvember 2018 Nvember 13, 2017 -- Applicatin due 11:59 p.m. CST. February 2019 Summary statements and award ntificatins are sent t applicants. VI. ABOUT THE COMPONENTS OF THE 2018-2019 LETTER OF INTENT AND APPLICATION A. What are the cmpnents f the Letter f Intent (LOI)? Principal investigatr: persnal infrmatin and bisketch Infrmatin abut the applicant rganizatin Research mentr: persnal infrmatin, letter f cmmitment, bisketch, and mentr training table Descriptin f the prpsed research prject B. What are the cmpnents f the Applicatin? Principal investigatr and prject infrmatin. Spnsring institutin infrmatin. Research Plan. Prject summary in lay language. Budget and budget justificatin. Specific aims. Research plan strategy: Significance. Innvatin. Apprach. Letters f supprt. Literature cited. AOTF Interventin Research Grant RFA Page 5 f 6
Prtectin f human subjects plan. Inclusin f wmen, minrities, and children. Cnsrtium/cntractual/cnsulting arrangements. IRB apprval letter/iacuc apprval (required but may be submitted at a later date. Grant will nt begin until AOTF receives IRB). Human subjects research training certificatin fr key persnnel. Appendices. Available resurces. Bigraphical sketches f c-investigatrs and ther key persnnel. Practice settings. VII. ABOUT THE KEY REVIEW CRITERIA FOR 2018-2019 APPLICATIONS A. What are the key review criteria fr the 2018-2019 applicatins? Overall impact scre Significance Innvatin Apprach Envirnment Investigatr(s) Prtectins fr human subjects Ptential fr subsequent funding -- lays the necessary grundwrk fr larger interventin studies and subsequent funding. Budget AOTF Interventin Research Grant RFA Page 6 f 6