SCTR Biomedical Research Bank Related RFA Funding Cycle. Release Date: May 30, 2012 Application Due Date: Noon July 10, 2012

Transcription

1 Suth Carlina Clinical & Translatinal Research Institute (SCTR) Request fr Applicatins (RFA) fr Pilt Prject Prgram Grants SCTR Bimedical Research Bank Related RFA Funding Cycle Release Date: May 30, 2012 Applicatin Due Date: Nn July 10, 2012 Pilt prject applicatins submitted under this RFA shuld be directly related t SCTR Bimedical Research Bank ( The bjective f this RFA is t build the SCTR Bimedical Research Bank cllectin with bispecimens that are meaningful t active and future translatinal research as well as help investigatrs btain bispecimens fr active translatinal research. Prpsed studies shuld cllect new bispecimens and stre them in the SCTR Bimedical Research Bank. SCTR Bimedical Research Bank has limited number f bispecimens already cllected that can be requested (details n hw t request are listed belw) t use in the prpsed studies. Hwever, it is required t cllect additinal (new) bispecimens and stre them in the SCTR Bimedical Research Bank t be eligible fr this RFA Studies prpsing nly t bank specimens withut a prpsed research plan fr their use, studies that prpse t cllect tissue ther than DNA, bld, plasma, serum, urine and bdy fluids, studies which will nt permit sharing f residual bispecimens will nt be cnsidered under this RFA. Applicatins submitted under this RFA shuld be hypthesis driven, answer scientifically meaningful questins and gather critical preliminary data that will eventually result in extramural grant applicatins t sustain the research. Any MUSC investigatr wh hlds a university faculty appintment is eligible t be a PI f an applicatin. Hwever if a PI has been funded by SCTR befre and has a delinquent prgress reprt will nt be funded. The grant mechanism f this RFA is tw-fld: Hwever the funding decisins will be made based n the scientific merit f the applicatins. Applicatins with budget requests f up t $50,000 will be funded with 100% SCTR funds (i.e. n matching fund requirement) Applicatins with budget requests f ver $50,000 and up t a limit f $100,000 shuld require PI s r investigatr team s matching fund cmmitment t match SCTR dllars 1:1. Matches must be in real funds and can be frm PI s Department/Divisin, Center r Fundatin grants but cannt be frm existing grants. Please refer t the Budget and Allwable Csts sectin f the RFA fr mre details. SCTR has services and prgrams that can help the investigatrs interested in this RFA if needed. Mre details are prvided in the Key Elements Sectin f the RFA. Investigatrs with questins regarding this RFA are urged t submit their questins via the SCTR Request Service (SPARC) using the Ask a Questin buttn at r call the SCTR SUCCESS Center at This will help Page 1

2 us t prperly rute questins t Jhn Arthur MD, Directr f the SCTR Bimedical Research Bank r t ther apprpriate persnnel. By accepting the SCTR funds and supprt, yu acknwledge the requirement t cite the Natinal Institute f Health (NIH) Grant Supprt t SCTR in each publicatin, press release r any ther dcuments similar t the fllwing: "This publicatin (r prject) was supprted by the Suth Carlina Clinical & Translatinal Research (SCTR) Institute, with an academic hme at the Medical University f Suth Carlina CTSA, NIH/NCATS Grant Number UL1TR The cntents are slely the respnsibility f the authrs and d nt necessarily represent the fficial views f the NIH." The mst imprtant thing t remember is t cite the SCTR grant number UL1TR OVERVIEW OF THE SCTR PILOT PROJECT PROGRAM SCTR s Pilt Prject Prgram aims t facilitate innvative, meaningful clinical and translatinal research with emphasis n diseases demnstrating significant prevalence in Suth Carlina. A key gal is t prmte scientific interactins between many disciplines f basic scientists (such as bimedical, bi-behaviral, cmputatinal, engineering, physical, scial, ecnmic, ethical and public health) and clinical scientists, and between investigatrs and the cmmunity t accelerate the prcess frm discvery and innvatin t imprved patient care. We als aim t prvide research supprt fr highly prmising trainees and junir faculty t shrten the time t research independence and fr prjects related t nvel technlgy and methdlgy develpments. OBJECTIVE OF THE RFA Obtaining apprpriate clinical bispecimens and patient data fr translatinal research is a majr impediment fr many investigatrs. The SCTR Bimedical Research Bank plans t develp a cllectin f DNA, bld, plasma, serum, urine and bdy fluids, that can be linked t demgraphic, clinical, billing and labratry data in the medical recrds in rder t facilitate and prmte active translatinal research studies. The SCTR bimedical research bank s cllectin is currently under develpment and des nt yet meet the needs f mst researchers. The bjective f this RFA is t build the SCTR Bimedical Research Bank cllectin with biispecimens that are meaningful t active and future translatinal research as well as help investigatrs btain bispecimens fr active translatinal research. KEY ELEMENTS The applicatins shuld prpse a new bispecimen cllectin, bank them in the SCTR Bimedical Research Bank and have a scientifically meritrius research plan indicating their use in active translatinal research. Investigatrs can prpse t use existing bispecimens in the SCTR Bimedical Research Bank but they must prpse t cllect additinal new bispecimens. If yu need mre infrmatin abut the existing bispecimens, please submit yur questin/request t SCTR SPARC Request System utilizing the Ask Us a Questin feature at r by calling the SUCCESS Center at Estimated Bimedical Research Bank Csts are listed under Budget and Allwable Csts sectin in this RFA. Nte: Budget cnsultatins are available thrugh the SCTR SUCCESS Center. Yu can submit yur request fr a cnsultatin using SCTR SPARC System (budget cnsult is listed under the SUCCESS Center) at r call the SCTR SUCCESS Center at The applicatin must include a detailed descriptin f plans t identify apprpriate research subjects, cllect bispecimens and data. Page 2

3 Nte: If needed, the SCTR Research Crdinatr Cre (RCC, can help the investigatrs t cllect and bank the bispecimens as a fee fr service. If yu need mre infrmatin abut the RCC, please submit yur questins and/r requests using SCTR SPARC Request Service at The applicants are encuraged t include cmmn language in the IRB apprved cnsent that allws samples t be banked and used fr future unspecified research. Investigatrs plan t use bispecimens fr future research will be required t have additinal IRB apprval/s depending n the studies. Nte: SCTR Regulatry Cre can wrk with the investigatrs t adapt the cmmn language and help with the regulatry needs specific t yur prpsed prject. Please submit yur questins and/r requests using SCTR SPARC Request Service (service is listed under SUCCESS Center) at The applicatin must include a plan fr the vlume f bispecimens t be cllected and the amunt that can be banked fr future use by ther investigatrs. When bld is btained, plans shuld be made t bank DNA frm the specimens even if it is nt prpsed fr the prject. This can be achieved by drawing an extra tube f bld (5cc) in a purple tp tube depending n the prject and as apprpriate. NOTE: SCTR Bimedical Research Bank Persnnel (Dr. Jhn Arthur and Sylvia Riddle) can help yu with mre specific details if needed. Please submit yur questins using SCTR SPARC System Ask Us a Questin feature at When samples require prcedures fr acquisitin that are mre cmplex than phlebtmy r urinatin, the applicatin must describe wh will btain the specimens and what specific training they have etc. NOTE: SCTR Clinical and Translatinal Research Center (CTRC at can help investigatrs if needed. Submit yur questins and/r requests using SCTR SPARC Request Service at Applicatins shuld include the number f subjects fr each prpsed study prviding justificatin fr the sample size (e.g. a statistical pwer analysis) and describe statistical methds required fr analysis f study data. The applicatins will be reviewed by a bistatistician. Althugh the applicatins will primarily be pilt prjects, they must be adequately pwered t prvide meaningful infrmatin abut the feasibility and size fr yur planned future studies t apply fr extramural grant applicatins. The investigatrs are required t identify at least ne f the ptential extramural grant applicatins and a prpsed research plan with a time line beynd the SCTR pilt prject applicatin. NOTE: Statistical Cnsultatins are available thrugh SCTR Bistatistics, Epidemilgy and Research Design Prgram ( if yu need. Please submit yur request using SCTR SPARC Request Service at Special cnsideratin will be given fr prpsals which emphasize cllectin f bispecimens and data in underrepresented minrity r culturally unique ppulatins. NOTE: SCTR Cmmunity Engagement Prgram Persnnel ( can help the investigatrs if needed. Please submit yur questins/request using SCTR SPARC Request Service at Page 3

4 KEY DATES RFA Release Date: May 30, 2012* Applicatins Due Date: Nn July 10, 2012** SRC Review Due: August 15, 2012 Just-in-Time Ntice: August 20, 2012 Earliest Anticipated Start Date: September 1, 2012 * The applicatin cnsists f an n-line frm and PDF uplads, and must be submitted nline thrugh the SCTR Pilt Prject Prgram website at ** On line applicatins must be successfully received by the SCTR Pilt Prject Prgram Office n later than the applicatin due date and time. If an applicatin is nt cmplete r nt submitted by the due date and time, it will be disqualified. SCTR AFFILIATED INSTITUTIONS Medical University f Suth Carlina Claflin University Clemsn University Greenville Hspital System Greenwd Genetic Center Health Sciences Suth Carlina Palmett Health Ralph H. Jhnsn VA Medical Center Suth Carlina Research Authrity Spartanburg Reginal Healthcare System University f Suth Carlina PROGRAM ELIGIBILITY NOTE: Any MUSC investigatr wh hlds a university faculty appintment is eligible t be a PI f an applicatin. Hwever, if a PI has been funded by SCTR befre and has a delinquent prgress reprt, the new applicatin will nt be funded. Principal Investigatr (PI): Any MUSC investigatr wh hlds a university faculty appintment is eligible t be a PI f a prpsal. Prfessrs, Assciate Prfessrs, and Assistant Prfessrs are eligible t apply as PIs. Investigatrs may serve as the PI f nly ne prpsal but can be C-Investigatrs (C- I) f the ther prpsals. Undergraduates, graduate students, clinical trainees, pst-dctral and clinical fellws, visiting faculty, and individuals with pending faculty appintments cannt serve as the PI f an applicatin, but may serve as a C-I prvided they meet the criteria listed belw fr C-Is. Members f SCTR affiliated institutins are eligible t be C-Is f the prpsals. Since ne f the gals f the SCTR pilt prjects is t help train the next generatin f clinical and translatinal investigatrs, we encurage junir investigatrs submit applicatins as Early Career investigatrs. Fr this mechanism, Early Career investigatrs are faculty members with n mre than fur years past pstdctral r specialty/subspecialty. The Early Career investigatrs applicatins receive special cnsideratin t fulfill SCTR gals f supprting highly prmising trainees and junir faculty t shrten the time t research independence since Early Career investigatrs are the future f clinical and translatinal research. The Principal Investigatrs (PIs) wh qualify as Early Career investigatrs shuld indicate their eligibility n the nline applicatin frm. Hwever, since experience and expertise will be criteria fr funding, we encurage junir faculty t recruit pertinent senir C-Investigatr(s) as mentrs. The PIs wh qualify as Early Career investigatrs shuld indicate their eligibility n the nline applicatin frm. Please read carefully the Early Career investigatr related review criteria listed in the APPLICATION REVIEW CRITERIA AND PROCESS sectin. Page 4

5 C- Principal Investigatr (C-PI): One C-PI is allwed. Hwever, a C-PI shuld have a significant rle in the prpsed prject t be named as the C-PI. The C-PI shuld be clearly identified in the applicatin narrative, n the budget and in the budget justificatin. On the nline applicatin, list the C-PI as the first C-I and shuld be indicated as a C-PI by their last name by entering (C-PI) within parentheses. C-Investigatr (C-I): SCTR Pilt Prjects require cllabrative research that crsses research disciplines, divisins, departments and/r institutins. Researchers must make a substantial cntributin t the prject in rder t be listed as C-Is. Substantial cntributrs shuld have 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). At least ne C-I is required, with a limit up t five C-Is (i.e. ttal investigatrs including the PI fr a prpsed prject t be six) are allwed t be listed. Cnsultants: If yu plan t use cnsultants fr the prpsed prject, please include their names in the nline applicatin after the C-Is infrmatin and indicate as a Cnsultant by entering (Cnsultant) within parentheses. BUDGET AND ALLOWABLE COSTS NOTE: Budget cnsultatins are available thrugh the SCTR SUCCESS Center. Yu can submit yur request fr a cnsultatin using SCTR SPARC System (budget cnsult is listed under the SUCCESS Center) at r call the SCTR SUCCESS Center at 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. Each budget item listed in the Frm Page 4 must be clearly justified. Estimated Bimedical Research Bank Csts per sample are (please nte that these csts may be adjusted at the time f prject funding by SCTR staff): Whle Bld Prcessing and Banking: $7 Plasma Extractin Prcessing and Banking: $7 DNA Prcessing and Banking: $11 Urine Prcessing and Banking: $6 Fr ther csts, please submit a cst request using the SCTR SPARC System via the Ask Us a Questin buttn ( Fr budget requests f mre than $50,000: The Budget and Justificatin Uplad shuld include tw separate budget frms and a justificatin clearly identifying the expenses t be paid fr by SCTR and the expenses t be paid fr by the PI s r investigatr team s matching funds. On the nline applicatin, uplad the budget and justificatin as ne single PDF file. Faculty Salary Supprt: Faculty salary supprt is allwed as apprpriate and the effrts requested are subjected t the NIH salary cap. Hwever yu must be able t demnstrate that yu can successfully accmplish yur prpsed scpe f wrk within the budget parameters. Other Persnnel Supprt: Salary and fringe benefits are allwed fr technical supprt, such as: Research Fellws, Research Assistants, Clinical Crdinatrs, Research Nurses, etc. If an applicatin prpses graduate students supprt (stipend, undergrad/graduate student Page 5

6 research assistant and lab csts etc), yu must prvide a justificatin as t hw wrk n this pilt prject related t the students dissertatin r Master s prject/thesis. Hwever, salary supprt fr ancillary persnnel, such as Mentrs, Secretaries, and Administrative Assistants, is nt allwed. Nn-persnnel Research Expenses: Sme allwable expenses are: supplies, equipment (under limited circumstances), study subjects stipends, study subjects transprtatin csts, in- and ut-patient care csts, and statistical and cmputatinal services including persnnel and cmputer time. All expenses must be directly related t the prpsed research. NOTE: Statistical cnsultatins are available thrugh SCTR Bistatistics, Epidemilgy and Research Design Prgram ( if yu need. Submit yur questins/request using SCTR SPARC as mentined befre. Unallwable csts: are general ffice supplies and equipment, cmputers and laptps (unless specifically requested and justified), membership dues and fees, subscriptin csts, mailing csts, and rent. Facilities and Administrative Csts: Facilities and administrative csts, als knwn as indirect csts, are nt permitted. AWARD DETAILS SCTR Pilt Prject Prgram will send the crrespndences related t the award t respective PIs via s. It is PI s respnsibility t respnd and cmmunicate with the SCTR Pilt Prject Prgram ffice as apprpriate. Please be advised that upn funding ntificatin t PI, additinal administrative dcuments including all the regulatry apprvals are required. Nte: The funding cannt be released until all applicable institutinal human and bisafety prtcls (such as IRB, IBC), and any ther required regulatry dcuments (such as INDs, IDE, and CITI Training) have been apprved and cpies sent t the SCTR Pilt Prject Prgram ffice. SCTR Pilt Prject Prgram ffice will send the JIT Ntice t the PIs f the funded prjects via with a web link t submit the JIT infrmatin including the cpies f the apprved regulatry dcuments. All the regulatry dcuments must be received by the Pilt Prject Prgram Office by the apprpriate JIT due date. We understand that sme regulatry dcuments may need lnger time t get apprval after the JIT Ntice is sent t the PIs. If fr sme reasn, these dcuments cannt be submitted by the apprpriate due date as indicated in the JIT letter, the PI shuld frward a written letter via explaining the reasns fr the delay. The prject may nt be funded if the SCTR Pilt Prject Prgram ffice des nt receive the required dcuments r reasnable explanatin within 8 weeks f the JIT Ntice. The maximum perid f award is 12 mnths. Hwever, the award perid depends n the satisfactry mid-term prgress reprt which will be cllected at 6 mnth frm the prject start date and reviewed by the SCTR Scientific Review Cmmittee (SRC). The SRC has the right t terminate a prject if prgress reprt is nt submitted r nt satisfactry. The prject end prgress reprt will be cllected at 12 mnths frm the prject start date. Please nte that the SCTR Pilt Prject Prgram ffice will cntinue t fllw the prgress f each prject pst-funding, by cllecting yearly scientific updates at least fr 5 years after the prject end date t determine the SCTR pilt prject funding success in terms f extramural grant funding applicatins, publicatins, IND/IDE, SBIR/STTR, patents, etc. This is in accrdance with the CTSA SCTR grant which is a cperative agreement with the Natinal Institutes f Health (NIH) and Natinal Center fr Advancing Translatinal Sciences (NCATS). Abut a mnth befre a prgress reprt is due, the Pilt Prject Prgram will send the PI a reminder via with a web link t submit the prgress reprt. Page 6

7 It is PI s respnsibility t infrm the Pilt Prject Prgram ffice f any changes t the prject, including departure frm the PIs institutin. This will help t determine hw bth parties shuld prceed such as t transfer PIs respnsibility t anther team member r t clse ut the prject. The PI shuld agree t return any funds nt expended in direct cnduct f this prject fr any reasn including successful prject cmpletin, terminatin frm the institutin, early prject terminatin r any ther reasn that shall arise. THE APPLICATION PROCESS Applicatin Due Date: Nn, July 10, Late applicatins will nt be accepted. All the applicatins cnsist f an nline frm and PDF uplads, and must be submitted thrugh the SCTR website at Click the apprpriate Apply link n this web page t fill ut the applicatin based n each grant mechanism. Please allw sufficient time befre the deadline t deal with any unexpected prblems in submitting the applicatin (gathering eracmmns user names, bisketches etc). SCTR Pilt Prject Prgram Office persnnel will be available t help shuld yu encunter prblems submitting the applicatin. The PIs wh qualify as Early Career investigatrs shuld indicate their eligibility n the nline applicatin frm. PDF Uplads: Prject Descriptin fllwing PHS 398 instructins: New NIH Frmat (1 page limit, Arial fnt size 11, at least 0.5 margins). 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 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 r technically literate reader. Using n mre than tw r three sentences, describe the Relevance f this research t public health. Mre details can be accessed at Budget and Justificatin: Details are listed abve in the BUDGET AND ALLOWABLE COSTS Sectin. Please nte the additinal requirements such as the matching fund cmmitment fr budges requesting mre than $50,000. Research Prpsal: The research prpsal shuld be submitted using the new NIH frmat f Specific Aims and Research Strategy which includes significance, Innvatin, and apprach. The NIH frmat can be accessed at (5 page limit excluding the Prject Descriptin Page described abve. Arial fnt size 11, at least 0.5 margins). Fr Budgets requesting mre than $50,000: Uplad a signed statement frm the PI and the prvider f the matching funds in the Uplad Department Divisin Chair Statement bx. Include clearly the surce and amunt f matching fund. Nte: The applicatin cannt be submitted withut uplading a matching fund cmmitment letter. PIs wh are applying fr nly SCTR funds (budget requests f up t $50,000) shuld still uplad a letter (yu can indicate smething similar t Budget requests are frm 100% SCTR funds f $----- ) in rder t prperly submit the applicatin. See the APPLICATION REVIEW CRITERIA AND PROCESS sectin belw fr specific review criteria that must be addressed in the prpsed research prpsal. Page 7

8 In additin t abve, translatinal ptential f the prpsed research, whether the SCTR funding wuld stimulate new and multidisciplinary cllabratins that therwise might nt have taken place, plans/ptential t secure future extramural funding including funding agency and mechanism such as R, P, U and thers must be included in the research prpsal. These criteria will be used t evaluate apprpriateness and need fr SCTR supprt and extent t which the prpsed research is cnsistent with the SCTR missin f prmting clinical and translatinal research. The research prpsal shuld infrmative enugh fr reviewers t understand the prpsed research withut any supprting dcuments. Applicants shuld include all the required details in the prpsal withut referring t additinal pages/dcuments. Applicatins identified as an Early Career Investigatr applicatin and/r a Nvel Methds/Technlgy applicatin must address the additinal review criteria utlined in the APPLICATION REVIEW CRITERIA AND PROCESS sectin belw in the research prpsal. A few additinal pages are allwed fr Early Career applicatins t uplad mentr/s supprt letters. Please include these additinal supprting dcuments at the end f the literature citatin pages and uplad all the pages as a single PDF. Additinal 1-2 pages are allwed fr literature citatins. Few additinal pages are allwed fr regulatry dcuments as apprpriate. NOTE: All the additinal pages shuld be added at the end f the research prpsal and uplad as a single PDF as directed in the applicatin. APPLICATION REVIEW CRITERIA AND PROCESS Overview The applicatins will be reviewed by at least tw reviewers, wh have expertise in relevant scientific disciplines and current research areas, accrding t the new NIH Peer Review guidelines as indicated at After the initial review, nly selected applicatins based n the verall impact scres will be discussed at the SRC meeting. The SRC will priritize the applicatins based n final verall impact scres (see belw) and will make funding recmmendatins t the SCTR Executive Cmmittee wh will make the final funding decisins. Review critiques f the applicatins that did nt get selected will be sent t the respective PIs. Since this is a ne time targeted RFA fr the SCTR Bimedical Research Bank, there will be n pprtunities fr applicatin resubmissins. Scring Reviewers are instructed t evaluate applicatins by addressing the six cre review criteria and additinal review criteria (listed belw) as applicable. Each reviewer s impact scre will reflect evaluatin f the verall impact f the prpsed prject in its entirety rather than the reviewer s scres given t each review criterin. Fr each applicatin that is discussed in the SRC meetings, a final verall impact scre will be given by each review member fllwing the SRC panel discussin. The SRC reviewers will address Additinal Review Cnsideratins listed belw fr each applicatin as applicable but these additinal review cnsideratins will nt be scred and shuld nt be cnsidered in prviding an verall impact/pririty scre. Six Cre Review Criteria fr Overall Impact/Pririty Scre fr ALL Grant Categries: i. Significance including Scientific Merit f Prpsed Prject: Des the prject address an imprtant health prblem r a critical barrier t prgress in the field? If the aims f the prject are achieved, hw will scientific knwledge, technical capability, and/r clinical practice be imprved? i.e. translatinal ptential f the prpsed research Hw will successful cmpletin f the aims change the cncepts, methds, technlgies, treatments, services, r preventative interventins that drive this field? Page 8

9 ii. Ptential t Secure Future Extramural Funding: Des the prject have high ptential t secure future extramural funding? iii. Investigatr(s): Are the PIs, cllabratrs, and ther researchers well suited t the prject? D they have established rles, skills and experience t carry ut the prject? Is there clearly established new trans-disciplinary cllabratin? i.e. cllabratin between basic and clinicians, clinicians and cmmunity, and vice versa If Early Stage Investigatrs r New Investigatrs, d they have apprpriate experience and training? If Early Stage Investigatrs, is there a defined mentrship plan with a senir/established investigatr (PI is required t submit) and timetable fr becming independent and a plan fr achieving research independence and ptential t lead t independent funding (with a plan t submit K r R applicatins) If established, have they demnstrated an nging recrd f accmplishments that have advanced their field(s)? If the prject is cllabrative, d the investigatrs have cmplementary and integrated expertise; is their rganizatinal structure apprpriate fr the prject? iv. Innvatin: Is the prject new, innvative, and translatinal? Des the applicatin challenge and seek t shift current research r clinical practice paradigms by utilizing nvel theretical cncepts, appraches r methdlgies, instrumentatin, r interventins? Are the cncepts, appraches r methdlgies, instrumentatin, r interventins nvel t ne field f research r nvel in a brad sense? Is a refinement, imprvement, r new applicatin f theretical cncepts, appraches r methdlgies, instrumentatin, r interventins prpsed? v. Apprach: Are the verall strategy, methdlgy, and analyses well-reasned and apprpriate t accmplish the specific aims f the prject? Are ptential prblems, alternative strategies, and benchmarks fr success presented? If the prject is in the early stages f develpment, will the strategy establish feasibility and will particularly risky aspects be managed? If the prject invlves clinical research, are the plans fr 1) prtectin f human subjects frm research risks, and 2) inclusin f minrities and members f bth sexes/genders, as well as the inclusin f children, justified in terms f the scientific gals and research strategy prpsed? Is there apprpriate justificatin prvided fr the number f subjects invlved? If the prpsed prject is related t the Nvel Methdlgy and Technlgy, is there a ptential value t multiple investigatrs facilitating clinical & translatinal research and supprting extramurally-funded research prjects? Is there an adequate business plan and cst effectiveness f allwing multiple investigatrs t use cre facilities? vi. Envirnment: Will the scientific envirnment in which the research will be dne cntribute t the prbability f success? Are the institutinal supprt, equipment and ther physical resurces available t the investigatrs adequate fr the prject prpsed? Will the prject benefit frm unique features f the scientific envirnment, subject ppulatins, r cllabrative arrangements? Page 9

10 vii. Additinal Review Cnsideratins: As applicable fr the prpsed prject, the SRC reviewers will address each f the fllwing items but will nt give scres and shuld nt cnsider them in prviding an verall impact/pririty scre. Budget & Perid Supprt: SRC members will cnsider whether the budget and the requested perid f supprt are fully justified and reasnable in relatin t the prpsed research. Page 10