EVERYONE, WELCOME.
I AM A MIDDLE AGED WHITE WOMAN
WITH SHOULDER-LENGTH BROWN HAIR
AND I'M WEARING A BLACKTOP WITH
SOME SPARKLES ON IT BECAUSE THIS
IS A BIG DEAL.
WE DID SPARKLES TODAY.
AND MY BACKGROUND IS THE BLUE
NICHD ZOOM BACKGROUND.
THANK YOU FOR JOINING TODAY.
WE HAVE A BIG, BIG GROUP, WHICH
I THINK IS REFLECTIVE OF THE
ENTHUSIASM FOR THIS PARTICULAR
FUNDING OPPORTUNITY.
I WANT TO THANK JOE FOR DOING
THE HEAVY LIFTING TODAY.
HE'S GOING TO BE WALKING YOU ALL
THROUGH NOFO.
I ALSO WANT TO THANK UPFRONT,
OUR COLLEAGUES AT SEVERAL OTHER
NIH INSTITUTES WHO ARE
CONTRIBUTING TO THIS IN A VERY
REAL AND MEANINGFUL WAY.
THE NATIONAL INSTITUTE ON
BIOMEDICAL IMAGING AND
BIOENGINEERING, THE NATIONAL
INSTITUTE ON DEAFNESS AND OTHER
COMMUNICATION DISORDERS, THE
NATIONAL INSTITUTE ON
NEUROLOGICAL DISORDERS AND
STROKE AND THE NATIONAL CENTER
FOR COMPLEMENTARY AND
INTEGRATIVE HEALTH.
WE REALLY COULD NOT DO THIS
PROGRAM WITHOUT THEIR
CONTRIBUTIONS.
SO THE FORMAT FOR TODAY AS JOE
WILL WALK THROUGH A SERIES OF
SLIDES GOING OVER THE KEY POINTS
OF THE NOFO.
WE ARE NOT GOING TO HAVE PEOPLE
COME OFF MUTE TO ASK QUESTIONS.
SO IF YOU HAVE QUESTIONS, PLEASE
PUT THEM IN THE Q&A AND WE ARE
GOING TO LEAVE PLENTY OF TIME TO
GET TO THEM AT THE END.
BUT WE WILL READ THEM ALLOWED
AND MODERATE THROUGH THE Q&A.
IF YOU HAVE QUESTIONS, PUT THEM
THERE.
AND YOU CAN PUT THEM IN THERE
ANY TIME DURING THE
PRESENTATION.
YOU DON'T HAVE TO WAIT UNTIL THE
END.
AND IF YOU DO HAVE ISSUES,
TECHNICAL ISSUES, PLEASE CHAT
THE HOSTS.
WE HAVE THE BEST VIRTUAL MEETING
SUPPORT TEAM AT NIH.
THEY WILL TAKE CARE OF US AND
OUR TEAM AT CIT.
SO, I THINK I COVERED
EVERYTHING.
I'LL TURN IT OVER TO JOE BONER
WHO IS THE PROGRAM OFFICER WHO
HAS BEEN LEADING THIS EFFORT.
THANK YOU.
>> THANK YOU FOR THAT
INTRODUCTION, THERESA.
NOW, I WILL SHARE MY SLIDES.
>> I'M A PROGRAM OFFICER HERE
WITH THE NATIONAL CENTER FOR
MEDICAL REHABILITATION RESEARCH
AT THE U.S. KENNEDY DRIVER
NATIONAL INSTITUTE OF CHILD
HEALTH AND HUMAN DEVELOPMENT.
I'M A WHITE MALE WITH GLASSES
WEARING A BLUE BLAZER AND A
WHITE BUTTON-DOWN SHIRT.
AND MY BACKGROUND IS THE NICHD
BLUE STANDARD ZOOM BACKGROUND.
WE ARE HERE TODAY FOR THE PRE
SUBMISSION TECHNICAL ASSISTANCE
WEBINAR FOR RFA-HD-25001, THE
P50 CLINICAL TRIAL OPTIONAL.
I HAVE NO DISCLOSURES.
JUST TO BRIEFLY GO THROUGH THE
AGENDA.
SO WE'RE GOING TO START
DISCUSSING THE RFA BACKGROUND AS
WELL AS THE OBJECTIVES AND
EXPECTATIONS FOR THIS FUNDING
INITIATIVE.
THEN WE'LL GO THROUGH AN
OVERVIEW OF THE PEER REVIEW OF
APPLICATIONS.
SO WE'LL DISCUSS THE SPECIFICS
OF THE REVIEW FOR THIS RFA AND
ALSO JUST SORT OF SOME GENERAL
BACKGROUND ON NIH REVIEW SO
EVERYONE IS ON EQUAL FOOTING.
THIRD, WE'RE GOING TO GO THROUGH
THE TIMELINE FOR SUBMISSION,
REVIEW AND SELECTION EVER
APPLICATIONS.
AND THEN WE SHOULD HAVE AMPLE
TIME FOR Q.
AND A. AT
Q&A AT THE END.
THE RFA BACKGROUND OBJECTIVES
AND EXPECTATIONS.
SO THIS RFA CONTINUES AND
EVOLVES MEDICAL REHABILITATION
RESEARCH RESOURCE PROGRAM.
THIS IS THE 6th ITERATION OF
THIS PROGRAM.
THIS IS THE THIRD DIFFERENT
FUNDING MECHANISM THAT NICHD HAS
USED FOR THIS PARTICULAR
PROGRAM.
THE RFA IS INFORMED BY A REQUEST
FOR INFORMATION THAT WAS
PUBLISHED IN JULY OF 2022 AND
THAT WAS FOLLOWED BY AN
EVALUATION OF THE MEDICAL
REHABILITATION RESEARCH RESOURCE
PROGRAM THAT WAS CONDUCTED WITH
THE NATIONAL ADVISORY BOARD FOR
MEDICAL REHABILITATION RESEARCH.
FIVE NIH INSTITUTES WILL BE
CONTRIBUTING FUNDS TO THIS
PROGRAM IN THE CURRENT CYCLE AND
WE EXPECT THE FUND 4-5 MEDICAL
REHABILITATION RESEARCH CENTERS.
IT IS EXPECTED THAT SUCCESSFUL
APPLICANTS WILL HAVE THE
OPPORTUNITY TO APPLY FOR ONE
RENEWAL BUT SUBSEQUENT RENEWALS
WOULD REQUIRE STRONG
JUSTIFICATION TO SHOW THAT THE
RESEARCH TOPIC REMAINS
SIGNIFICANT AND INNOVATIVE.
FOR THE CURRENT CENTERS, WE ARE
NOT ACCEPTING RENEWAL
APPLICATIONS FOR THE CURRENT RFA
AND THAT IS BECAUSE THERE ARE
INSIGNIFICANT CHANGES TO THE
FORMAT AND IT WASN'T SEEN THAT
RENEWALS WOULD BE APPROPRIATE.
HOWEVER, ALL CURRENT CENTERS ARE
ELIGIBLE TO COMPETE FOR NEW
CENTERS.
THE GOAL OF THIS INITIATIVE IS
TO ENHANCE THE CAPABILITY OF
MEDICAL REHABILITATION
INVESTIGATORS TO UNDERSTAND
MECHANISMS OF FUNCTIONAL
RECOVERY, DEVELOP THERAPEUTIC
STRATEGIES, IDENTIFY GAPS AND
IMPROVE THE LIVES OF PEOPLE WITH
DISABILITIES.
A SUCCESSFUL CENTER WILL
CONTRIBUTE TO MEDICAL
REHABILITATION RESEARCH
INFRASTRUCTURE, BY DEVELOPING
DISEASESINATING TECHNIQUES,
DATA, THEORIES, RESEARCH
PROGRAMS AND EXPERTISE.
EACH APPLICATION WILL INCLUDE
FIVE COMPONENTS.
FIRST IS THE OVERALL COMPONENT.
THIS PART OF THE APPLICATION
WILL DISCUSS WHY THIS
APPLICATION IS BEING PROPOSED AS
A COMPLETE CENTER, RATHER THAN
INDIVIDUAL COMPONENTS.
THE ADMINISTRATIVE CORE WILL
SUPPORT THE CENTER, ORGANIZE
CENTER ACTIVITIES, BUILD AND
MAINTAIN A WEBSITE AND MANAGE
THE PILOT PROGRAM IF ONE IS
PLANNED.
THE PILOT PROGRAM IS OPTIONAL
AND I WILL TALK A LITTLE BIT
MORE ABOUT THAT IN A MINUTE.
THE RESOURCE CORE WILL SERVE AS
A LOCAL AND NATIONAL RESOURCE TO
REHABILITATION RESEARCHERS.
IT WILL FUNCTION LOCALLY BECAUSE
IT CABLE USED AND UTILIZED BY
THE CENTER ITSELF AND NATIONALLY
BECAUSE IT IS EXPECTED THAT SOME
OF THE RESOURCES WILL BE SHARED
NATIONALLY.
THE RESEARCH PROJECT CORE WILL
PROPOSE BASIC TRANSLATIONAL
AND/OR CLINICAL RESEARCH THAT
HAS THE POTENTIAL TO BROADLY
IMPACT THE MEDICAL
REHABILITATION RESEARCH FIELD.
IT IS EXPECTED THAT THE DATA AND
RESOURCES DEVELOPED IN THE MAIN
RESEARCH PROJECT WILL BE USEFUL
TO THE MEDICAL REHABILITATION
RESEARCH FIELD, BE IN HIGH
DEMAND AND WIDELY SHARED VIA THE
CENTER CORES.
THE COMMUNITY ENGAGEMENT AND
OUTREACH CORE WILL SERVE AS A
CONDUIT BETWEEN OTHER MEDICAL
REHABILITATION RESEARCH CENTERS,
OTHER INSTITUTIONS, OTHER
ORGANIZATIONS, RESEARCHERS,
CLINICIANS AND THE PUBLIC.
AND THEN APPROPRIATE TARGET FOR
THE COMMUNITY ENGAGEMENT, AN
OUTREACH CORE WILL DEPEND ON THE
TOPIC THAT IS PROPOSED FOR THE
CENTER.
APPLICANTS WILL PROPOSE A
PROGRAM OF RESEARCH AND
DISSEMINATION IN A SPECIFIC
CONTENT AREA.
THE RESEARCH PROJECT WILL FIT
WITHIN THAT OVERARCHING
SUBMISSION OF THE MEDICAL
REHABILITATION RESEARCH CENTER
WITHIN THAT OVERALL CONTENT AREA
AND HAVE THE POTENTIAL FOR BROAD
IMPACT IN MEDICAL REHABILITATION
RESEARCH.
THERE ARE SOME INSTANCES IN
WHICH AN APPLICATION MAY BE
DEEMED NON RESPONSIVE AND IN
THOSE CASES, IT WOULD BE
APPLICATION THAT IS PROPOSE A
SINGLE EFFICACY TRIAL IN A SING
CONDITION OR IN A
CLOSELY-RELATED CONDITION AND
THOSE WILL BE DEEMED NON
RESPONSIVE AND WITHDRAWN.
APPLICATIONS ARE ONLY PROPOSE TO
COLLECT DEMOGRAPHIC DATA ON A
DISABILITY POPULATION OR A
COMMUNITY, MAY BE DEEMED NON
RESPONSIVE AND WITHDRAWN PRIOR
TO REVIEW.
APPLICATIONS THAT FAIL TO
ADDRESS REHABILITATION AS
DEFINED IN THE RFA, COULD BE
WITHDRAWN PRIOR TO REVIEW AND
APPLICATIONS THAT FAIL TO
INCLUDE PEOPLE WITH LIVED
EXPERIENCE, AS DESCRIBED IN THE
RFA, COULD BE WITHDRAWN PRIOR TO
REVIEW.
IF YOU HAVE ANY QUESTIONS ABOUT
THIS, I RECOMMEND YOU CONTACT ME
DIRECTLY AND WE CAN SCHEDULE A
MEETING TO DISCUSS QUESTIONS
ABOUT RESPONSIVENESS.
THERE ARE EIGHT HIGH PRIORITY
TOPIC AREAS THAT ARE IDENTIFIED
IN THE RFA AND THESE WILL
RECEIVE FUNDING PRIORITY.
THOSE EIGHT TOPICS ARE PRECISION
REHABILITATION, OUTCOME MEASURES
TO ADVANCE CLINICAL RESEARCH,
DIGITAL HEALTH BIOMARKERS FOR
REHABILITATION, DATA SCIENCE FOR
REHABILITATION, SOCIAL
DETERMINANTS OF HEALTH, HEALTH
PROMOTION FOR PEOPLE WITH
PHYSICAL DISABILITIES, ASSISTIVE
AND REHABILITATIVE TECHNOLOGIES,
DISSEMINATION AND IMPLEMENTATION
RESEARCH.
EACH OF THESE AREAS IS DEFINED
IN GREATER LENGTH IN THE RFA AND
SO YOU CAN FIND THOSE
DEFINITIONS THERE AND SEE IF
YOUR APPLICATION FITS.
YOU ARE ABLE TO PROPOSE A TOPIC
THAT IS NOT IN THE LIST, BUT YOU
SHOULD KNOW THAT IT WOULD HAVE
TO BE PARTICULARLY IMPACTFUL TO
RECEIVE FUNDING.
I MENTIONEDDED THIS IS AN
OPTIONAL PILOT PROGRAM AS PART
OF THE ADMINISTRATIVE BOARD.
SO APPLICANTS MAY PROPOSE A
NATIONWIDE PILOT PROGRAM TO FUND
SMALL GRANTS TO EARLY-STAGE
INVESTIGATORS OR INVESTIGATORS
ENTERING A NEW AREA OF RESEARCH.
AGAIN HERE, NATIONWIDE MEANS
THAT THE PILOT PROGRAM WOULD BE
OPEN BOTH TO APPLICANTS FROM THE
CENTER BUT ALSO FROM APPLICANTS
ACROSS THE U.S.
THE PILOT STUDIES WILL HAVE
DIRECT COSTS LIMITED TO 35,000
DOLLARS PER YEAR FOR ONE YEAR.
ALTHOUGH THE APPLICANTS ARE ABLE
TO PROPOSE PILOTS THAT WOULD BE
EITHER REST FUNDS OR SHORTER
DURATION.
EACH CENTER MAY REQUEST UP TO
150,000 DOLLARS OF OPPORTUNITY
POOL FUNDS PER YEAR, INCLUSIVE
OF ALL F&A COSTS, INCLUDING
SUBAWARD F&A COSTS, IN ADDITION
TO THE 750,000 PER YEAR DIRECT
COSTS FOR THE REST OF THE
CENTER.
SO TO TALK ABOUT THAT A LITTLE
MORE JUST TO CLARIFY, THE CENTER
BUDGET IS 750,000 DOLLARS PER
YEAR DIRECT COSTS.
AND THE INSTITUTION CAN REQUEST
F&A COSTS ON TOP OF THAT.
IF YOU DO PROPOSE A PILOT
PROGRAM IN THE ADMINISTRATIVE
CORE, THEN THAT PILOT PROGRAM IS
LIMITED TO 150,000 DOLLARS PER
YEAR TOTAL COSTS.
SO YOU WANT THE BUDGETS TO
REFLECT BOTH THE PRIMARY
INSTITUTION F&A COSTS, THE
SUBAWARD INSTITUTION F&A COSTS
AND FOR THAT TO BE UNDER THAT
150,000 DOLLAR LIMIT.
AS I MENTIONED, THIS OPTIONAL
PILOT PROGRAM WILL BE WITHIN THE
ADMINISTRATIVE CORE.
THIS RFA HAS A REQUIREMENT FOR
INCLUSION OF PEOPLE WITH LIVED
EXPERIENCE AND ALL APPLICATIONS
MUST INCLUDE A TWO-PAGE REQUIRED
OTHER ATTACHMENT, TITLED, PLAN
FOR INCLUSION OF PEOPLE WITH
LIVED EXPERIENCE THAT DETAILS
THE PLAN TO INCORPORATE THE
EXPERIENCE AND EXPERTISE OF
PEOPLE LIVING WITH EXPERIENCE
LIVING WITH THE DISABILITIES
THROUGHOUT THE CENTER
PROGRAMMING.
THIS PLAN MUST BE INCLUDED WITH
THE OVERALL COMPONENT AS AN
OTHER ATTACHMENT.
I'M GOING TO RESEARCH AND RELATE
OTHER PROJECT INFORMATION, AND
AGAIN, PARENTHESES UNDER
OVERALL, BECAUSE THIS WILL BE
ATTACHED TO THE OVERALL
COMPONENT.
SO THIS IS TWO PAGES IN ADDITION
TO THE 12 PAGES THAT YOU
RECEIVED FOR THE OVERALL
COMPONENT.
APPLICATIONS THAT FAIL TO
INCLUDE THIS TWO PAGE
REQUIREMENT WILL BE WITHDRAWN
PRIOR TO REVIEW.
WE DO NOT WANT TO DO THIS.
WE DO NOT WANT TO HAVE TO
WITHDRAWAL APPLICATIONS FOR THIS
REASON.
BUT IT IS SOMETHING WE WOULD BE
REQUIRED TO DO.
SO PLEASE DO MAKE SURE THAT IT
IS INCLUDED AS AN OTHER ATTACH
ATTACHMENT.
NEXT WE'RE GOING TO MOVE TO THE
PEER REVIEW OF APPLICATIONS.
THE PEER REVIEW WILL OCCUR AT
THE -- WITH THE NICHD SCIENTIFIC
REVIEW BRANCH WHO WILL
COORDINATE A SPECIAL EMPHASIS
PANEL TO REVIEW THIS RFA.
THE REVIEW WILL BE BASED ON THE
CRITERIA IN RFAHDA25001 AND NIH
PEER-REVIEWED POLICY AND
PROCEDURES.
THIS SPECIAL EMPHASIS PANEL WILL
HAVE COLLECTIVE EXPERTISE BASED
ON THE CONTENT OF THE
APPLICATIONS RECEIVED.
AND AT LEAST THREE REVIEWERS
WILL BE ASSIGNED TO EACH
APPLICATION.
PLEASE DO NOT CONTACT MEMBERS OF
THE REVIEW PANEL NOR SHOULD YOU
SUGGEST INDIVIDUALS WHO WOULD BE
APPROPRIATE FOR REVIEW.
THIS WOULD PLACE THOSE
INDIVIDUALS IN CONFLICT WITH THE
RFA AND THEY WOULD NOT BE
ELIGIBLE.
THE POLICY ON POST SUBMISSION
MATERIALS DOES APPLY TO THIS RFA
AND YOU CAN FIND MORE DETAILS IN
THE TWO NOTICES LISTED HERE.
IF YOU DO HAVE QUESTIONS ABOUT
THESE MATERIALS, AFTER YOU
SUBMITTED YOUR APPLICATION, YOU
CAN CONTACT THE NICHD SCIENTIFIC
REVIEW BRANCH CONTACT THAT IS ON
THIS RFA, THAT IS DR. JOANNA,
AND YOU CAN FIND HER CONTACT
INFORMATION AT THE BOTTOM OF THE
RFA AND AT THE END OF THIS
PRESENTATION.
JUST A LITTLE BACKGROUND ON THE
NIH REVIEW PROCESS.
NIH UTILIZES A 9-POINT RATING
SCALE WHERE ONE IS EXCEPTIONAL
AND 9 IS POOR FOR ALL
APPLICATIONS AND THAT WILL BE
USED FOR THIS RFA REVIEW AS
WELL.
REVIEWERS WILL BE ASKED TO
PROVIDE A PRELIMINARY OVERALL
IMPACT SCORE AND AN IMPACT SCORE
FOR EACH COMPONENT REFLECTING
THEIR ASSESSMENT ON THE
LIKELIHOOD THE PROJECT WILL
EXERT A SUSTAINED POWERFUL
INFLUENCE ON THE RESEARCH FIELD.
FOR THIS RFA, PRELIMINARY
OVERALL IMPACT SCORES WILL
DETERMINE WHICH APPLICATIONS ARE
DISCUSSED.
TYPICALLY THE TOP 50% OF
APPLICATIONS WILL BE REVIEWED
BASED ON PRELIMINARY IMPACT
SCORES AND THEN REVIEWERS ARE
GIVEN THE OPPORTUNITY TO DISCUSS
AN APPLICATION THAT IS NOT
SLATED TO BE DISCUSSED.
SO, ALL APPLICATIONS HAVE THE
OPPORTUNITY TO BE DISCUSSED IF A
REVIEWER WISHES TO DISCUSS IT.
THE FINAL IMPACT SCORE WILL BE
RELEASED ABOUT THREE DAYS AFTER
THE REVIEW MEETING ENDS AND YOU
CAN EXPECT THE SUMMARY STATEMENT
ABOUT 30 DAYS AFTER THE REVIEW
DATE.
FINALLY, IMPACT SCORES ARE NOT
PROVIDED FOR APPLICATIONS THAT
ARE NOT DISCUSSED, HOWEVER, WILL
YOU YOU WILL RECEIVE A SUMMARY
STATEMENT THAT CONTAINS YOU'RE 3
QUITEAKS FROM YOUR PRIMARY
REVIEWERS.
THIS IS SAY MULTICOMPONENT
APPLICATION AND SO I WANT TO
DISCUSS HOW THE REVIEW WILL BE
CONDUCTED FOR EACH COMPONENT.
SO THE OVERALL COMPONENT WILL BE
SCORED ON OVERALL IMPACT AS WELL
AS THE TYPICAL SCORED REVIEW
CRITERIA.
THOSE ARE SIGNIFICANCE
INVESTIGATORS, INVASION,
APPROACH AND ENVIRONMENT.
IN ADDITION, THERE ARE REVIEW
CRITERIA THAT ARE SPECIFIC TO
THIS RFA AND WE'LL DISCUSS THOSE
NEXT.
BUT FOR THE OVERALL COMPONENT,
WE WILL SEE AGAIN OVERALL IMPACT
SCORE THEN SIGNIFICANCE,
INVESTIGATOR, INNOVATION,
APPROACH AND ENVIRONMENT.
THE RESEARCH PROJECT WILL BE
SCORED IN A SIMILAR WAY WITH AN
OVERALL IMPACT SCORE FOLLOWED BY
5 REVIEW CRITERIA.
THE RESEARCH PROJECT ALSO HAS
REVIEW CRITERIA SPECIFIC TO THIS
RFA.
THE OTHER THREE COURSE,
ADMINISTRATIVE, RESOURCE AND THE
COMMUNITY ENGAGEMENT AND
OUTREACH CORE, WILL EACH RECEIVE
AN OVERALL IMPACT SCORE BUT THEY
WILL NOT RECEIVE INDIVIDUAL
SCORES FOR SIGNIFICANCE,
INVESTIGATOR INNOVATION,
APPROACH AND ENVIRONMENT.
INSTEAD, THE OVERALL IMPACT
SCORE OF THOSE CORES WILL BE
BASED ON THE FACTORS IN SECTION
5 OF THE RFA.
SO REVIEWERS WILL CONSIDER THE
CRITERIA AS DESCRIBED IN SECTION
5 OF THE RFA TO DETERMINE
SCIENTIFIC AND TECHNICAL MERIT.
PLEASE READ THIS SECTION VERY
CAREFULLY AS THIS WILL GO A LONG
WAY IN DETERMINING THE SUCCESS
OF YOUR APPLICATION.
IF YOU'RE PROPOSING A CLINICAL
TRIAL, PLEASE ALSO ADDRESS THE
QUESTIONS RELATED TO THE
CLINICAL TRIALS.
SO HERE ARE THE SPECIFIC REVIEW
CRITERIA FOR THE OVERALL
COMPONENT.
I'M NOT GOING TO GO IN DEPTH ON
EACH OF THESE REVIEW CRITERIA
BECAUSE THERE ARE A FEW BUT I
WANT TO POINT OUT WHERE YOU CAN
FIND THEM AND INTRODUCE THEM
BRIEFLY.
SO AGAIN, TO FIND THESE SPECIFIC
REVIEW CRITERIA, GO TO SECTION 5
OF THE RFA.
WITHIN THAT YOU LOOK FOR THE
OVERALL COMPONENT SUBHEADING
FOLLOWED BY THE SIGNIFICANCE
SUBHEADING AND THEN YOU'LL SEE
THE REVIEW CRITERIA SPECIFIC TO
THIS RFA, UNDER SIGNIFICANCE.
AND YOU'LL FIND THIS FIRST
BULLET POINT THAT LIST SEVERAL
QUESTIONS RELATED TO PEOPLE'S
LIVED EXPERIENCE AND HOW THEY
WERE INCLUDED IN THE
APPLICATION.
AS YOU CONTINUE DOWN THE REVIEW
CRITERIA, YOU WILL COME TO THE
APPROACH SECTION.
AND THERE YOU WILL FIND TWO
BULLET POINTS THAT OUTLINE
QUESTIONS SPECIFIC TO THIS RFA.
AND THESE QUESTIONS DEAL WITH
HOW THE APPLICATION WOULD
FUNCTION OR HOW THE CENTER WOULD
FUNCTION AS A CENTER RATHER THAN
AS INDIVIDUAL COMPONENTS.
THE RESEARCH PROJECT ALSO HAS
REVIEW CRITERIA SPECIFIC TO THIS
RFA.
GO TO SECTION 5, GO PAST THE
OVERALL COMPONENT.
YOU WILL REACH THE RESEARCH
PROJECT COMPONENT.
BELOW THAT LOOK FOR THE SUGGESTS
SECTION AND YOU'LL FIND THESE
FOUR BULLET POINTS SPECIFIC TO
THIS RFA.
AGAIN, PLEASE READ THESE VERY
CAREFULLY AND MAKE SURE THAT
THEY ARE ADDRESSED IN YOUR
APPLICATION.
THIS IS WHAT REVIEWERS WILL BE
ASKED TO CONSIDER WHEN THEY ARE
SCORING YOUR APPLICATION.
THERE ARE REVIEW CRITERIA
SPECIFIC TO THE ADMINISTRATIVE
CORE AND YOU WILL FIND THESE
LISTED TOWARDS THE BOTTOM OF
SECTION 5 UNDER THE HEADING,
REVIEW CRITERIA SPECIFIC TO THE
ADMINISTRATIVE CORE.
SINCE WE ARE NOT DOING THE
SUBSCORES FOR SIGNIFICANCE,
INNOVATION, INVESTIGATORS,
ET CETERA, YOU WILL JUST FIND
THESE SIX QUESTIONS.
AND THESE ARE THE SIX QUESTIONS
THAT REVIEWERS WILL BE ASKED TO
CONSIDER WHEN ASSIGNING AN
OVERALL IMPACT SCORE FOR THE
ADMINISTRATIVE WORK.
THE SCORING FOR THE REVIEW FOR
THE RESOURCE CORE AND THE
COMMUNITY ENGAGEMENT AND
OUTREACH CORES BOTH FUNCTION
SIMILARLY.
THE RESOURCE CORE HAS THREE
BOLDED QUESTIONS AS DOES THE
COMMUNITY ENGAGEMENT AND
OUTREACH CORE.
AND YOU WILL FIND THOSE AT THE
BOTTOM OF SECTION 5 NEAR THE
REVIEW CRITERIA FOR THE PREVIOUS
SCORE.
THIS PRESENTATION INCLUDES
SEVERAL PEER-REVIEWED RESOURCES
SUCH AS VIDEOS THAT PROVIDE
INSIGHT TO THE NIH GRANT REVIEW
PROCESS, LINKS TO THE NICHD
SCIENTIFIC REVIEW BRANCH PAGE,
RESOURCES FOR USING ERA
COMMENTS.
THOSE ARE PROBABLY MORE
APPROPRIATE FOR THE INDIVIDUALS
WHO WILL BE SUBMITTING THE
APPLICATION AND DOING THE
SUBMISSION PROCESS.
AND THEN THERE IS A LINK FOR THE
ERA HELP DESK.
IF YOU HAVE ISSUES SUBMITTING
YOUR APPLICATION AS IT GETS
CLOSE TO THE DUE DATE, PLEASE
CONTACT THE ERA SERVICE DESK.
THAT'S WHAT THEY ARE THERE TO
DO.
THEY ARE THERE TO PROVIDE VERY
TIMELY HELP.
IF YOU E-MAIL ME, I AM JUST
GOING TO DIRECT YOU TO GO BACK
TO THE ERA SERVICE DESK BECAUSE
IT'S NOT SOMETHING I CAN
GENERALLY HELP YOU WITH.
NOR DO I HAVE THE EXPERIENCE
THAT THEY DO.
SO NEXT WE'RE MOVING ON TO THE
TIMELINE FOR SUBMISSION REVIEW
AND SELECTION OF APPLICATIONS.
THESE DATES ARE ALL FOUND IN THE
RFA.
BUT I WANTED TO GO OVER THEM
QUICKLY HERE.
SO, AS YOU PROBABLY KNOW BY NOW,
THIS WAS POSTED ON APRIL 3.
THE OPEN DATE, THE DATE FOR THE
EARLIEST SUBMISSION IS JUNE 30
BUT YOU'RE NOT REQUIRED TO
SUBMIT BY THAT TIME.
YOU WON'T RECEIVE ANY BENEFIT IN
TERMS OF AWARD.
YOU DO GET THE OPPORTUNITY TO
MAKE SURE YOUR APPLICATION HAS
UPLOADED PROPERLY.
JUNE 30 IS ALSO THE LETTER OF
INTENT DUE DATE.
LETTER OF INTENT IS NOT REQUIRED
NOR IS SAY BINDING, BUT IT DOES
HELP US NICHD AND PARTICULARLY
IN THE SCIENTIFIC REVIEW BRANCH,
PLAN FOR THE REVIEW.
AND SO, THE PURPOSE HERE IS TO
GET AN IDEA OF HOW MANY
APPLICATIONS WE SHOULD EXPECT
AND SORT OF WHAT KEY PERSONNEL
WILL BE ASSOCIATED WITH THOSE
PROJECTS.
AND SO THE PROCESS FOR
SUBMITTING THE LETTER OF INTENT
IS FAIRLY INFORMAL.
IT IS DESCRIBED IN THE RFA BUT
ESSENTIALLY YOU JUST SEND ME AN
E-MAIL WITH A BRIEF OUTLINE,
SUMMARY, OF YOUR PROPOSAL AND
YOU CAN ALSO LET ME KNOW IF
THERE IS ANY KEY PERSONNEL THAT
WILL BE ASSOCIATED WITH IT.
THE APPLICATION DUE DATE IS JULY
30, 2024.
SO PLEASE DO KEEP THAT IN MIND.
THE REVIEW WILL OCCUR IN
NOVEMBER OF 2024 IN TIME TO BE
CONSIDERED AT THE JANUARY
2025NICHD ADVISORY COUNCIL
MEETING.
AND WE ARE EXPECTING THE
EARLIEST START DATE FOR THESE
CENTERS WILL BE APRIL OF 2020.
SO, NOW WE'RE GOING TO MOVE TO
THE QUESTION AND ANSWER BUT
WHILE WE DO THAT, I WANT TO ADD
THIS CONTACT INFORMATION UP
HERE.
YOU CAN FIND ALL OF THESE
CONTACTS AT THE END OF THE RFA
AT THE BOTTOM OF THE RFA.
AND WE HAVE SEVERAL COLLEAGUES
FROM OTHER NIH INSTITUTES THAT
ARE CONTRIBUTING TO THIS AND IF
YOU WOULD LIKE TO DISCUSS YOUR
PROPOSAL WITH THEM, THAT'S
SOMETHING WE CAN ABSOLUTELY DO.
BUT I WOULD ASK THAT YOU INCLUDE
ME IN ON THAT JUST SO WE CAN BE
CONSISTENT ACROSS ALL OF OUR
CONVERSATIONS.
AND YOU'LL THEN SEE THAT
DR. JOANNA E-MAIL ADDRESS IS
ALSO HERE, AS WELL AS MAGGIE
YOUNG'S CONTACT INFORMATION.
SHE IS THE BRANCH CHIEF FOR THE
GRANTS MANAGEMENT BRANCH AT
NICHD, AND SHE CAN ANSWER ANY
QUESTIONS RELATED TO THE
FINANCIAL ASPECTS OF THE
APPLICATION OR THE MORE
ADMINISTRATIVE PARTS OF THE
APPLICATION.
AND WITH THAT, I WILL STOP
SHARING OR I'LL BRING UP -- I'LL
TRY TO LEAVE THIS SCREEN UP AND
THEN JUST BRING UP THE Q&A.
>> I'LL ASK YOU THE QUESTIONS.
>> SURE.
>> OKAY.
SO THERE IS A COUPLE OF
QUESTIONS ABOUT THE LETTER OF
INTENT.
EXPLAIN HOW IT'S DIFFERENT THAN
MAYBE LIKE A DOD LETTER OF
INTENT OR -- IT'S NOT REQUIRED.
YOU DON'T GET ANY FEEDBACK ON --
>> YES.
YOU WON'T GET ANY FEEDBACK ON
THE LETTER OF INTENT.
IF YOU DO WANT TO DISCUSS YOUR
BUDGET AND RECEIVE SOME OF THE
THAT FEEDBACK, SEND ME AN E-MAIL
AND WE CAN SCHEDULE A ONE-ON-ONE
ZOOM CALL TO DISCUSS YOUR
PROPOSAL.
BUT YES, THE LETTER OF INTENT,
IT IS VERY INFORMAL AS FAR AS
OTHER LETTERS OF INTENT GO.
IT IS NOT REQUIRED, NOT BINDING.
YOU CAN ABSOLUTELY CHANGE YOUR
TOPIC.
YOU CAN CHANGE YOUR STUDY TEAM.
THAT'S ALL FINE.
IT'S JUST TO GIVE US AN EXTRA 30
DAYS TO UNDERSTAND THE SCOPE OF
HOW MANY APPLICATIONS WE SHOULD
BE EXPECTING.
AND IT'S NOTHING MORE THAN THAT.
>> SO IT IS NOT A DATING EVENT.
YOU DON'T SUBMIT THE LETTER OF
INTENT AND THEN WE SAY, YES, YOU
MAY APPLY.
SO YOU CAN APPLY WITHOUT PUTTING
IT IN OR WITH.
THANK YOU.
WE'VE GOT IN A FEW QUESTIONS.
HERE IS AN EASY ONE.
CAN WE GET THE SLIDES AFTER THE
MEETING?
I WILL TAKE THAT ONE.
I THINK WE WILL TRY TO POST
THESE ON OUR WEBSITE.
THIS IS BEING RECORDED AND WE
WILL POST IT ON OUR WEBSITE AS
WELL.
JOE, WE HAVE THE SPECIAL COUNCIL
REVIEW QUESTION.
DOES THE P50 COUNT TOWARDS THAT?
>> THE QUESTION IS, NO -- IT
DOESN'T COUNT IN EITHER
DIRECTION.
AND WHAT I MEAN BY THAT IS,
BECAUSE THIS IS AN RFA, IT
ALREADY GOES TO SPECIAL COUNCIL
REVIEW BUT WE WON'T BE
CONSIDERING THE AMOUNT OF MONEY
THAT THE INVESTIGATORS ALREADY
HAVE IN THAT WAY.
THEN ALSO, BECAUSE IT'S A P50,
IT DOES NOT CONTRIBUTE TO THE
PI'S LEVEL OF SUPPORT FOR FUTURE
CONSIDERATIONS.
SO, IF YOU APPLIED FOR AN R01
NEXT YEAR, THIS WOULD NOT
CONTRIBUTE TO THE LEVEL OF
SUPPORT THAT YOU HAVE.
>> COMING IN FASTER THAN I CAN
CAN -- I DON'T THINK I QUITE
UNDERSTAND THE FIRST QUESTION.
IS THERE A PREFERENCE FOR
RESOURCE CORE WITH A STRONGER
EXTERNAL-FACING STRUCTURE?
I'M ASSUMING THAT MEANS EXTERM
SUPPORT VERSUS INTERNAL.
DO YOU WANT TO ANSWER THAT ONE?
>> I THINK THE ANSWER TO THAT
IS, IT'S WHAT WILL THE REVIEWERS
THINK ESSENTIALLY.
I DON'T THINK WE HAVE A
PREFERENCE WITHIN NICHD.
IT WILL BE VERY SPECIFIC TO THE
PROPOSAL YOU'RE MAKING.
SO, IF YOU'RE PROPOSING A STRONG
EXTERNAL COMPONENT TO YOUR
RESOURCE CORE, THEN I THINK YOU
WANT TO SAY WHY THAT IS OF
BENEFIT TO THE RESEARCH --
REHABILITATION RESEARCH FIELD.
HOW IT'S GOING TO BE IMPACTFUL,
THINGS LIKE THAT.
SO IT'S NOT -- THERE IS NOT A
DEFAULT ONE WAY OR THE OTHER.
IT IS UP TO YOU TO MAKE THE
CASE.
>> THERE IS A QUESTION ABOUT
SHOULD YOU BE TARGETING ONE OF
THE FIVE ICs?
I WILL SAY THESE ALL GET
ASSIGNED TO NCMRR AND WE WILL BE
ADMINISTERING THEM.
SO, NO.
I GUESS IS MY SHORT ANSWER.
BUT WE WILL HAVE STAFF INVOLVED
FROM THE OTHER ICs AND THEN
THE MANAGEMENT OF IT.
DO YOU WANT TO ADD ANYTHING TO
THAT, JOE?
>> NO, I THINK THAT COVERS IT
WELL.
>> IS THERE A NUMBER -- A LIMIT
FOR THE NUMBER OF APPLICATIONS
FROM AN INSTITUTION?
>> NO.
>> AND I CHECKED IT.
NO, THERE IS NOT.
DO YOU WANT TO TAKE THE ONE
ABOUT APPLICATIONS THAT TARGET
MORE THAN ONE FOCUS AREA?
>> SURE.
SO, APPLICATIONS CAN TARGET MORE
THAN ONE FOCUS AREA BUT THE
BENEFIT IS ACHIEVED BY TARGETING
ONE.
SO YOU'LL BE CONSIDERED FOR AS
BEING RESPONSIVE OR IN THE HIGH
RESPONSE CATEGORY IF YOU TARGET
ONE.
ONE THING I WILL SAY IS THAT IF
YOU'RE TARGETING MANY, YOUR
CENTER MAY SEEM UNFOCUSED SO
THAT IS SORT OF THE DOWNSIDE TO
IT.
SO YOU WANT TO MAINTAIN FOCUS IN
YOUR CENTER.
SOME CENTERS WILL SORT OF BY
THEIR NATURE, APPLY TO MORE THAN
ONE FOCUS AREA, BUT YOU SHOULD
NOT BE SORT OF BENDING YOUR
SCIENCE TO MEET TWO.
THERE IS VERY LITTLE BENEFIT TO
THAT.
>> THERE IS A QUESTION ABOUT HOW
WE WILL MEET SELECTIONS.
DO WE INTEND TO FUND MORE THAN
ONE CENTER IN MORE THAN ONE
PRIORITY AREA?
>> WE WOULD FUND MORE THAN ONE
CENTER IN THE SAME AREA IF THEY
WERE -- WE DO CONSIDER PORTFOLIO
BALANCE WHEN MAKING FUNDING
DECISIONS SO WE WOULDN'T
NECESSARILY FUND TWO
HIGHLY-OVERLAPPING APPLICATIONS;
BUT IF THEY WERE TWO DISTINCT
AREAS, TWO APPROACHES, BOTH
MERITORIOUS, THEN WE WOULD
CONSIDER FUNDING BOTH.
>> THERE IS A QUESTION ABOUT
COLLABORATION BETWEEN THE
CENTERS.
SO HOW IMPORTANT IS THE
COLLABORATION WITH OTHER CENTERS
FOR RESPONSIVENESS?
>> SO THIS IS A CHALLENGE.
SO, TO SET UP AHEAD OF THE
APPLICATION, RIGHT?
BECAUSE YOU DON'T KNOW WHO WILL
BE FUNDED ET CETERA.
IT IS NOT SOMETHING THAT WE
PRIORITIZE THROUGH THE
APPLICATION PROCESS.
BUT WE WILL WORK WITH THE
CENTERS AFTER THEY ARE AWARDED
TO TRY TO FIND AREAS WHERE THERE
CAN BE COLLABORATION.
AND IF YOU GUYS RECALL FROM THE
P2C DAYS, THERE WAS A SEPARATE
SECTION ON COLLABORATION.
WE HAVE REMOVED THAT FROM THE
P50.
IS IT EXPECTEDDED THAT THERE IS
GOING TO BE SIGNIFICANT R LO 1
GRANTS FROM THE PEOPLE WHO ARE
APPLYING?
DO YOU HAVE TO BE PART OF NIH TO
APPLY?
>> I WOULD SAY, NO.
THAT IS NOT EXPECTED.
WE HAVE CERTAINLY HAD SORT OF --
TO USE A NON TRADITIONAL
APPLICANTS IN THE PAST THAT HAVE
BEEN SUCCESSFUL.
>> I'M JUST GOING TO REMIND
PEOPLE IF YOU COULD PUT YOUR
QUESTIONS IN THE Q&A, NOT THE
CHAT.
THAT MAKES IT EASIER FOR ME.
THEN I ONLY NEED TO LOOK AT ONE
PLACE.
SO I'M GOING TO FINISH WITH THE
Q&A AND THEN I'LL GO BACK AND
CHECK THE CHAT TO SEE IF I
MISSED ANYBODY.
EARLY CAREER INVESTIGATORS.
SHOULD THEY BE ENCOURAGED OR
DISCOURAGED FROM APPLYING?
>> ENCOURAGED TO APPLY.
BUT THE ESI BENEFITS FOR
EARLY-STAGE INVESTIGATORS ONLY
APPLY TO R OWE 1s SO THERE IS
NO ADDITIONAL BENEFIT FOR HAVING
A PI --
>> I'M GOING TO SAY THAT IS
GOING TO ADDRESS THE QUESTION,
SHOULD WE EMPHASIZE EARLY-STAGE
INVESTIGATORS OR JUNIOR FACULTY?
CAN WE -- HAND HOLD PIs?
>> YES.
>> CAN ONE INSTITUTION RECEIVE
TWO AWARDS IF THE AREAS ARE
DIFFERENT?
>> COULD YOU REPEAT THAT ONE?
>> WOULD WE AWARD TWO OF THESE
TO THE SAME INSTITUTION?
>> YES, IF THEY WERE BOTH
MERITORIOUS AND NOT OVERLAPPING,
ET CETERA.
>> I WILL SAY, TECHNICALLY, YES,
BUT WE HAVE TO HAVE A REALLY,
REALLY GOOD REASON TO FOCUS THAT
MUCH IN ONE INSTITUTION.
ARE THE SPECIFIC AIMS PAGES
SEPARATE FROM THE PAGE ELEMENTS
FOR EACH RESEARCH STRATEGY PAGE
LIMIT?
>> THAT IS A GOOD QUESTION.
I BELIEVE THEY ARE INCLUDED, BUT
I'M ACTUALLY NOT SURE.
>> WE'RE GOING TO FLAG THAT ONE
TO DOUBLE CHECK.
SO WHAT DID YOU SAY, JOE?
YOU THOUGHT THEY WERE INCLUSIVE
OF THE 12 PAGES, FOR EXAMPLE?
>> I THINK SO, YES, BUT I'M
LOOKING IT UP AT THIS MOMENT.
>> CAN WE HAVE MULTIPLE
INSTITUTIONS COMING IN TOGETHER?
YES, I -- SO THE QUESTION IS, IS
THERE GUIDANCE ON HOW MANY
INSTITUTIONS SHOULD PARTICIPATE
IN A SUBMISSION?
AND WE DON'T HAVE ANY
LIMITATIONS OR PREFERENCES.
IN GENERAL, WHEN MULTIPLE
INSTITUTIONS ARE COLLABORATING,
THERE SHOULD BE A REASON WHY AND
NOT DUPLICATIVE EFFORTS.
THAT WOULD BE MY GENERAL
COMMENT.
>> I'M LOOKING AT THE RFA RIGHT
NOW AND GOING BACK TO THAT
SPECIFIC AIMS QUESTION, THE
SPECIFIC AIMS PAGE DOES FALL
WITHIN THE RESEARCH PLAN.
SO, IT'S WITHIN THE -- I'M GOING
TO -- WE'LL FOLLOW-UP.
I'M SORRY.
>> YOU STUMPED US.
>> YES.
>> DO THE PILOT FUNDS HAVE TO GO
TO A TRADITIONAL RESEARCHER?
COULD THEY GO INSTEAD TO
SERVICES FOR AN INDEPENDENT
LIVING OR A SOCIAL SERVICES
PROVIDER THAT IS INTERESTED IN
PARTICIPATING IN RESEARCH OR
USING A RESEARCH TOOL?
>> THEY CAN GO TO A
NON-TRADITIONAL RESEARCHER BUT
THEY DO HAVE TO BE USED FOR
RESEARCH AND NOT SERVICE.
SO, SERVICES CAN BE PROVIDED AS
PART OF RESEARCH QUESTION BUT IT
DOES NEED TO BE A RESEARCH
QUESTION.
>> SO I WILL REPHRASE THIS
QUESTION.
SO IF YOUR INSTITUTION ALREADY
HAS A CTSA, CAN YOU LEVERAGE
THAT?
PLUSES OR MINUSES TO THAT?
IS IT ENCOURAGED OR DISCOURAGED?
>> I THINK AS WITH ANY
APPLICATION, IT WOULD BE
ENCOURAGED TO LEVERAGE THE
EXISTING RESOURCES THAT YOU CAN.
>> THERE HAS BEEN A FEW
QUESTIONS ABOUT THE RESEARCH
PROJECT.
SO IS THIS A BIG RO. OWE 1 OR
TECHNOLOGY DEVELOPMENT OR
SOMETHING ELSE?
>> SO I THINK THE KEY FOR
UNDERSTANDING THE RESEARCH
PROJECT IS TO LOOK AT THE REVIEW
CRITERIA FOR THE RESEARCH
PROJECT AND SO IT'S NOT A BIG
RFA -- I'M SORRY, A BIG RO1 IN
THE SENSE THAT IT'S NOT A LARGE
CLINICAL TRIAL, RIGHT?
IT'S INTENDED TO BE SOMETHING
THAT MAYBE WOULD NOT DO WELL IN
REVIEW AS A TRADITIONAL RO1.
IT IS NOT LIMITED TO TECHNOLOGY
DEVELOPMENT, BUT TECHNOLOGY
DEVELOPMENT COULD FIT WITHIN THE
UMBRELLA OF THE RESEARCH PLAN.
AND SO, THE IDEA HERE IS THAT
THE END RESEARCH PRODUCT WOULD
BE SOMETHING THAT IS EITHER
USEABLE OR COULD BE
DISSEMINATEDDED TO OTHER
RESEARCHERS OR COULD SERVE AS A
PLATFORM FOR OTHER RESEARCHERS
TO USE IN OTHER CONDITIONS.
SO THE REASON WHY THE DEFINITION
IS SORT OF BROAD AND
NON-SPECIFIC IS BECAUSE WE DO
WANT APPLICANTS TO BE INNOVATIVE
WITH IT AND TO REALLY PROPOSE
SOMETHING THAT WOULD BE
DIFFICULT TO FUND UNDER OTHER
CONDITIONS.
OBVIOUSLY SOMETHING THAT WOULD
BE IMPACTFUL TO THE FIELD BUT
SOMETHING THAT WOULD BE MAYBE
CHALLENGING TO FUND UNDER OTHER
MECHANISMS.
>> I'M GOING TO FOLLOW-UP ON
THAT.
CAN THE PROPOSAL INCLUDE
PRECLINICAL AND CLINICAL AIMS?
>> IT CAN, YES.
>> DOES THIS RFA REPEAT EVERY
YEAR?
>> IT DOES NOT.
THIS PROGRAM TYPICALLY
RECOMPETES EVERY FIVE YEARS.
>> CAN YOU HAVE AN INTERNATIONAL
COLLABORATOR?
>> YOU CAN HAVE AN INTERNATIONAL
COLLABORATOR, BUT FOREIGN
APPLICATIONS FROM FOREIGN
INSTITUTIONS ARE NOT ALLOWED.
>> SO FOREIGN SUBCOMPONENT IS
OKAY?
>> YES.
>> THERE IS A QUESTION ABOUT
REQUIREMENTS FOR THE PIs
CITIZENSHIP.
>> I DON'T THINK THERE IS ANY
REQUIREMENTS FOR THE PIs TO
HAVE CITIZENSHIP.
BUT THE APPLICATION COMES FROM
THE INSTITUTION AND THE
INSTITUTION HAS TO BE A
U.S.-BASED INSTITUTION.
>> THEY ARE COMING IN HOT HERE.
DOES THE COST FOR THE CONFERENCE
GO IN THE COMMUNITY OUTREACH
CORE?
>> SO IT SHOULD GO UNDER THE
CORE WHERE IT'S LISTED AND THE
REQUIREMENTS THAT --
>> WE'RE GOING TO FLAG THAT ONE
AS WELL.
IT'S EITHER IN COMMUNITY
OUTREACH OR ADMINISTRATION OR
ADMINISTRATIVE.
>> YES.
>> SO WE HAVE A QUESTION, IS
THERE A SINGLE SCORE GIVEN THAT
INCLUDES THE SCORES OF THE
OVERALL RESEARCH AND THREE
CORES?
HOW IS THAT CALCULATED?
>> I DON'T KNOW IF JOANNA OR
HELEN WANT TO THE COME OFF MUTE
AND TAKE THAT BUT THE SHORT
ANSWER IS, THERE IS NOT A
CALCULATION THAT IS DONE FOR THE
OVERALL SCORE.
REVIEWERS ARE ASKED TO PROVIDE
THEIR OVERALL SCORE.
IT'S NOT A MATHEMATICAL
CALCULATION.
AND THEY CAN WEIGH THE DIFFERENT
COMPONENTS HOW THEY WOULD CHOOSE
TO WEIGH THEM.
>> DID WE GET THAT RIGHT,
JOANNA?
>> YES, EXACTLY.
>> THIS IS A LITTLE MORE
PHILOSOPHICAL.
CAN YOU TALK ABOUT THE
INTERCONNECTEDNESS OF THE CORES
AND THE RESEARCH PROJECT?
>> SURE.
SO I THINK THAT THE CENTER
ITSELF WILL HAVE AN OVERALL
MISSION THAT THE RESEARCH
PROJECT CONTRIBUTES TO.
AND THEN THE CORES WILL BE
CONTRIBUTING TO THAT OVERALL
MISSION AS WELL.
AND THE INTERCONNECTEDNESS OF
THE CORES AND THE RESEARCH
PROJECT WILL BE VERY SPECIFIC TO
WHAT THE TOPIC OF THE CENTER IS
AND WHAT THE TOPIC OF THE
RESEARCH PROJECT IS.
AND SO, SOME CENTERS MAY BE MORE
FOCUSED ON SORT OF
COMMUNITY-LEVEL OUTREACH,
INTERACTING WITH PEOPLE WITH
DISABILITIES AT THE INDIVIDUAL
LEVEL.
SOME CENTERS MAY BE MORE FOCUSED
AT SORT OF SAY, DISSEMINATION
IMPLEMENTATION RESEARCH, AND MAY
BE MORE FOCUSED AT THE CLINICAL
LEVEL.
SO HOW THOSE CORES INTERACT WILL
DEPEND VERY MUCH ON WHAT THE
TOPIC OF THE CENTER IS.
AND SO I THINK OBVIOUSLY THE
RESEARCH PROJECT IS GOING TO BE
A BIG PART OF THE CENTER BUT IT
IS NOT THE WHOLE.
SO JUST THINKING ABOUT WHAT IS
THE OVERARCHING MISSION OF THE
CENTER THAT THAT RESEARCH
PROJECT IS CONTRIBUTING TO AND
HOW MANY OTHER CORES CONTRIBUTE
TO THAT AS WELL.
>> DO EXISTING CENTERS GET
PREFERENCE OR WILL WE ENCOURAGE
NEW CENTERS?
>> THE EXISTING CENTERS WILL NOT
GET A PREFERENCE.
>> I THINK EACH TIME WE DO THIS
IN THE PAST, THERE HAS BEEN
ABOUT A 50% TURNOVER IN THE
CENTERS.
SO I THINK IT'S A PRETTY HEALTHY
TURNOVER.
AND AGAIN, WE ARE CHANGING
MECHANISMS SO, THAT'S A GOOD
CHANCE FOR RESTARTS.
OR REFRESH.
>> YES.
>> QUESTIONS ABOUT -- THIS IS
SIMILAR TO THE CTSA QUESTION
BEFORE BUT -- CAN YOU LEVERAGE
THAT IN YOUR P50 APPLICATION?
>> I THINK YOU'RE WELCOME TO
LEVERAGE ANY RESOURCES AT YOUR
DISPOSAL AT YOUR INSTITUTION OR
AT YOUR COLLABORATOR'S
INSTITUTIONS.
>> THERE IS A COUPLE OF
QUESTIONS ABOUT WHETHER INDUSTRY
COLLABORATIONS ARE A SPECIAL
EMPHASIS OR ARE THEY ALLOWED?
>> THEY ARE NOT SPECIAL EMPHASIS
SPECIFICALLY.
THEY ARE NOT ONE OF THE EIGHT
TOPIC AREAS BUT THEY WOULD BE
ALLOWED.
>> THIS IS LIKE WACK A MOLE.
>> I SEE THAT ONE THAT HASN'T
BEEN ADDRESSED YET.
WOULD IT BE APPROPRIATE TO TEST
AN INTERVENTION, A CLINICAL
TRIAL FOR THE RESEARCH PROJECT
VERSUS A PILOT STUDY?
I KNOW IT'S NOT SUPPOSED TO BE A
SIMILAR CONDITION BUT ARE THERE
OTHER GUARDRAILS RESEARCHERS
WILL BE THINKING ABOUT WHEN A
PROPOSED CLINICAL TRIAL -- SO IT
IS APPROPRIATE TO PROPOSE A
CLINICAL TRIAL FOR THE RESEARCH
PROJECT OR FOR THE PILOT STUDIES
FOR THAT MATTER.
I THINK IF YOU'RE PROPOSEING A
TRIAL IN A SINGLE CONDITION, YOU
HAVE TO MAKE IT VERY CLEAR HOW
THAT TRIAL IS INFORMING SORT OF
A BIGGER QUESTION, AND HOW IT
COULD BE APPLIED BROADLY.
AND SO, IT'S NOT THE SENSE OF --
AGAIN IT'S NOT -- THE INTENTION
IS NOT FOR THIS TO JUST BE A
SLIGHTLY LARGER EFFICACY TRIAL.
THE GOAL HERE IS TO MOVE THE
FIELD FORWARD MORE BROADLY.
UNDERSTANDING THAT IN DOING
THAT, THERE MUST BE OR MAY NEED
TO BE, USE CASES SPECIFIC USE
CASES, THAT YOU'RE EXPLORING.
SO I THINK ONE OF THE WAYS YOU
WOULD BE ABLE TO EXPLORE THE
ADAPTABILITY OF WHATEVER IT IS
THAT YOU'RE RESEARCHING, IS THAT
YOU WOULD HAVE MULTIPLE
CONDITIONS SERVICE USE CASES.
IF YOU'RE NOT ABLE TO DO THAT,
THEN IT'S SORT OF DRAWS IN THE
QUESTION AS HOW ADAPTABLE THIS
RESEARCH PRODUCT WOULD BE.
>> SO THERE IS A RELATED
QUESTION.
IS THERE A DISADVANTAGE TO
FOCUSING ON A SINGLE POPULATION,
PATIENT POPULATION?
>> YES, THERE IS A SLIGHTLY
DIFFERENT QUESTION BECAUSE IF
YOU'RE NOT NECESSARILY TALKING
ABOUT A SINGLE EFFICACY TRIAL.
JUST LIKE TESTING A SINGLE
PRODUCT.
BUT MAYBE ADDRESSING A
POPULATION'S NEEDS MORE BROADLY.
AND I THINK AGAIN, IT COULD BE
INTERESTING, AN INTERESTING USE
CASE FOR A MODEL THAT IS BEING
DEVELOPED THAT COULD BE APPLIED
TO OTHER USE CASES AS WELL.
AND I THINK THAT IS WHAT YOU
WANT TO KEEP IN MIND.
SO HOW WOULD THIS RESEARCH
PROJECT THAT YOU'RE MAKING, HOW
COULD IT BE USED IN OTHER USE
CASES TO REALLY BRING UP THE
IMPACT, POTENTIAL IMPACT FOR
WHAT YOU'RE RESEARCHING?
>> DO YOU LOSE YOUR ESI STATUS?
I LOOKED THAT ONE UP.
NO, IF YOU GET A P50, YOU
ACTUALLY DON'T LOSE YOUR ESI
STATUS, BASED ON WHAT I'M
READING FROM THE NIH WEBSITE.
I'LL LIKE AT JOANNA TO CONFIRM
FOR ME, BUT THIS IS NOT AN R --
GO AHEAD.
>> EXACTLY.
IT'S ONLY APPLIED TO RO1s.
>> THIS IS NOT CONSIDERED AN RO1
EQUIVALENT.
WHICH I HOPE GETS YOU ALL
THINKING, LIKE THIS SHOULD NOT
JUST BE AN RO1.
WE HAVE ALL OF THESE OTHER
THINGS AND I HOPE THAT HELPS
FRAME.
IS THE RESEARCH PROJECT MORE OF
AN INFRASTRUCTURE PROJECT AS
OPPOSED TO A STANDARD RO1?
I HOPE THAT ANSWERS THAT
QUESTION.
I THINK WE ADDRESSED --
>> I WANTED TO CLARIFY THAT TO
REQUIRE MORE SEARCH IF AN
APPLICANT LOSE ESA STATUS OR
NOT.
WHAT I SEE IS THAT MOST NIH
AWARD TYPES AND YOUR NEW --
STATUS AND THERE WILL BE AT
LEAST OF AWARDS.
SO IF SOMEBODY IS INTERESTED IN
THAT, PLEASE E-MAIL ME AND I
WILL SEND YOU THE LINK.
SINCE IT REQUIRES MORE SEARCHING
IF THIS IS AMONG -- IF P FIRSTY
IS AMONG AWARD TYPES THAT WILL
LEAD TOKING THE NEW INVESTIGATOR
STATUS -- LEAD TO LOSING THE NEW
INVESTIGATOR STATUS.
>> HOW WILL -- SO PEOPLE WITH
LIVED EXPERIENCE ARE REQUIRED TO
BE INVOLVED BUT HOW WILL
REVIEWERS BE INSTRUCTED TO
CONSIDER THE INCLUSION OF PEOPLE
WITH LIVED EXPERIENCE?
>> SO, THAT IS THE REVIEW
CRITERIA SPECIFIC TO THIS RFA
UNDER THE OVERALL COMPONENT IN
THE SIGNIFICANCE SECTION.
THAT'S SPECIFICALLY WHERE
REVIEWERS ARE ASKED TO CONSIDER
THAT AND THEN YOU CAN SEE THERE
IS A LIST OF QUESTIONS THERE.
SORT OF GOING -- ASKING
REVIEWERS TO CONSIDER SEVERAL
ELEMENTS OF HOW PEOPLE WITH
LIVED EXPERIENCE ARE INCLUDED.
SO YOU CAN LOOK AT THAT SECTION
AND SEE HOW THAT IS USED.
>> THERE IS A QUESTION ABOUT
DEVELOPING DEVICES DURING THE
AWARD VERSUS RELYING ON
COMMERCIALLY-AVAILABLE ONES.
I WOULD SAY WE DON'T HAVE A
STANCE ON THAT.
YOU SHOULD BE USING THE
APPROPRIATE TOOLS FOR THE
SCIENCE AND IF YOU NEED TO
DEVELOP THEM, THEN MAYBE THAT'S
PART OF IT.
BUT IF THEY ALREADY EXIST, THEN
THERE IS NO REASON NOT TO USE
THEM.
THERE IS A QUESTION ABOUT
BUDGET.
DO YOU WANT TO ADDRESS THE
QUESTION ABOUT BUDGET?
>> FOR THE PILOT BUDGET?
>> YES.
>> SO THE PILOT BUDGETS -- THE
P50 INSTITUTION IS ENTITLED TO
INDIRECTS ON THOSE PILOTS.
THE INSTITUTIONS THAT IS
RECEIVING THE PILOT AWARD IS
ELIGIBLE TO REQUEST INDIRECTS
FROM THE P50 INSTITUTION.
AND YOU JUST HAVE TO PLAN FOR
THAT UNDER THIS 150,000 DOLLAR
CAP.
AND SO, THAT IS THE WAY THAT
WE'RE ASKING TO DO IT.
AND THEN YOU ALSO GET THE P50
INSTITUTION GETS THE NORMAL
INDIRECTS WHILE THE 750 DIRECT
COST LIMIT.
AND THOSE ARE SEPARATE.
SO 750 DIRECT, PLUS INDIRECTS,
PLUS AN ADDITIONAL 150,000 TOTAL
COST FOR THE PILOTS.
IF YOU CHOOSE TO DO THE PILOTS.
>> WE'RE COMING UP ON OUR LAST
COUPLE OF MINUTES.
IF WE DON'T GET TO YOUR
QUESTION, YOU HAVE JOE'S E-MAIL.
THAT FIRST ONE ON THE SCREEN.
>> THERE IS ONE ABOUT THE
INDIRECT COSTS FOR THE
NON-PRIME.
MAYBE A BETTER QUESTION FOR
MAGGIE BUT I WOULD SAY IT'S THE
NORMAL WAY YOU WOULD DO IT FOR
AN RO1.
IT'S ONLY THE PILOT PROJECTS
THAT ARE --
>> SO THERE IS A QUESTION
ABOUT -- IN RESPONSE TO YOUR
ANSWER TO THE RESEARCH PROJECT
QUESTION, IT SOUNDS LIKE YOU'RE
LOOKING FOR MORE OF A TECH
DEVELOPMENT RATHER THAN A
RESEARCH QUESTION.
I THOUGHT THE BIG DIFFERENCE
BETWEEN THIS WAS TO EMPHASIZE
RESOURCE DEVELOPMENT, NOT A
RESEARCH QUESTION.
SO, I WOULD SAY THAT THERE IS A
RESOURCE CORE.
SO THERE IS SOME ELEMENT OF
CREATING SOMETHING THAT CAN BE
DISTRIBUTED.
NOW THAT SOMETHING IS VERY, VERY
BROAD.
IT COULD BE A TOOL.
IT COULD BE A THING.
IT COULD BE AN ALGORITHM.
IT COULD BE -- YOU KNOW, WE HAVE
LET YOU BE CREATIVE WITH WHAT
THAT RESOURCE IS.
WE DON'T WANT TO CONFINE YOU.
DID I ANSWER THAT ENOUGH, JOE?
>> THE ONLY THING ISLAND ADD IS
WITH THE -- I WOULD ADD --
P2Cs THERE WAS MORE EMPHASIS
ON TRAINING.
AND HERE IT'S MORE ON SORT OF
RESEARCH DEVELOPMENT AND THEN
RESOURCE SHARING.
I THINK THAT'S THE DIFFERENCE.
CAN WE USE OR REDUCE FNA RATE
FOR THE PILOTS RATHER THAN THE
FULL RATE?
THE ANSWER IS YES, IT'S WHATEVER
YOU REQUEST THE F&A RATE TO BE
UP TO YOUR CAP THAT YOU
NEGOTIATE, UP TO THE RATE YOU
NEGOTIATEED.
>> I WILL END IT WITH, HOW MANY
DO YOU THINK WE'RE GOING TO
AWARD?
>> 4-5.
>> OKAY.
I JUST WANT TO THANK EVERYBODY
FOR THEIR QUESTIONS AND THE
ATTENDANCE TODAY.
I WANT TO THANK JOE AND JOANNA
FOR BEING ON TO CONTINUE ANSWER
QUESTIONS.
AND ALL THE IT STAFF THAT MAKES
THIS HAPPEN.
WE ARE GOING TO GET THE
RECORDING POSTED.
WE'RE GOING TO TAKE ALL 60
SOMETHING QUESTIONS AND SEE IF
WE NEED TO DOE SOME FAQs
MAYBE, JOE?
>> YES.
>> AND GET THOSE POSTED AS WELL.
HOPEFULLY FAIRLY QUICKLY.
YOU GUYS HAVE ABOUT 2 1/2 MONTHS
BEFORE THESE NEED TO COME IN.
AND AGAIN, IF YOU'RE NOT SEEING
YOUR SPECIFIC QUESTION
ADDRESSED, PLEASE FEEL FREE TO
REACH OUT TO JOE BECAUSE HE
KNOWS MORE ABOUT THIS THAN I DO.
>> THANK YOU, EVERYBODY.
WE'RE REALLY EXCITED ABOUT THE
ENTHUSIASM AND I AM MORE THAN
HAPPY TO ANSWER ANY MORE OF YOUR
QUESTIONS.
PLEASE DO REACH OUT.
THANK YOU VERY MUCH.