WELCOME TO THE 108th NIAMS
ADVISORY COUNCIL.
I'M NEIL ROBERTS.
I'LL BE YOUR MODERATOR.
A REMINDER KEEP YOUR PHONES ON
MUTE UNLESS YOU PLAN TO SPEAK
AND IF YOUR CAMERAS ON, WE CAN
SEE YOU AND CAN SEE EVERYTHING
YOU'RE DOING AND WITH THAT I'LL
TURN THIS OVER TO DR. LINDSEY
CRISWELL.
THANK YOU.
COMBL UD UH WUGS RESULTS
>> LET ME CHECK WITH KATHY.
DO WE HAVE A QUORUM?
>> WE'RE WAITING FOR ONE MORE
PERSON TO JOIN THE MEETING.
I THINK WE'RE GOOD TO GO NOW,
DR. CRISWELL.
>> GOOD MORNING, EVERYBODY.
WELCOME.
THANK YOU SO MUCH FOR JOINING
US.
I'LL CALL THE 108th MEETING OF
THE NATIONAL ARTHRITIS AND
MUSCULOSKELETAL AND SKIN
DISEASES ADVISORY COUNCIL
DISORDER.
ALL MEETING OPEN TO THE PUBLIC
AS REQUIRED BY LAW EXCEPT THE
REVIEW AND DISCUSSION OF GRANT
APPLICATIONS WHICH WE'LL BE
ADDRESSING IN CLOSED SESSION
LATER THIS AFTERNOON.
BEFORE I BEGIN, I HAVE TWO
ANNOUNCEMENTS.
IF I CAN HAVE MARK SHOW THE
SLIDES.
FIRST IS WIDE SAD.
MS. LIZ BORAS PASSED DUE TO HER
LONG BOUGHT WITH CANCER.
-- BOUT WITH CANCER SHE LOVED
NIAMS AND WILL BE GREATLY MISSED
BY THE INSTITUTE.
SECONDLY, I WANT TO FORMALLY
INTRODUCE DR. SALAITA AS THE
EXECUTIVE SECRETARY AND SHE
CHIEF OF THE NIAMS SCIENTIFIC
REVIEW BRANCH A POSITION HELD
SINCE 2013 AND ACTING NIH REVIEW
POLICY OFFICER.
PRIOR TO JOINING NIAMS SHE WAS A
PROGRAM FOR THE NATIONAL
INSTITUTE ON ALCOHOL ABUSE AND
ALCOHOLISMS AND WORKED AT THE
NIH CENTER FOR SCIENTIFIC REVIEW
AS SCIENTIFIC REVIEW OFFICER
REFERRAL OFFICER AND ACTING
INTEGRATED REVIEW GROUP OR IRG
CHIEF.
AS YOU CAN SEE, SHE HAS A WEALTH
OF EXPERIENCE AT THE NIH.
SHE ALSO HAS A DOCTORAL DEGREE
FROMMONS -- FROM JOHNS HOPKINS
AND THE FLOOR IS NOW YOURS.
>> THANK YOU, DR. CRISWELL.
GOOD MORNING AND WELCOME.
I HAVE A FEW HOUSEKEEPING ITEMS
TO GO OVER THIS MORNING AND THEN
TURN THE MEETING BACK TO
DR. CRISWELL.
WE HAVE A LIMITED NUMBER OF
NIAMS STAFF ON THE ZOOM CALL
THIS MORNING AND THE REST OF THE
STAFF IN THE PUBLIC ARE VIA THE
LIVE VIDEOCAST.
IF ANY STAFF MEMBER WATCHING ON
THE VIDEOCAST HAS AN URGENT
COMMENT OR QUESTION PLEASE
E-MAIL MELINDA NELSON AT
MELINDA.NELSON@NIH.gov AND
SHE'LL REFER IT TO ME.
WE ENCOURAGE THE PUBLIC TO SEND
COMMENTS 15 DAYS BEFORE THE
MEETING AND THE MAILINGS WILL BE
SENT TO MELINDA NELSON.
ANYONE ON THE ZOOM CALL MAY
SPEAK BUT BE SURE TO MUTE WHEN
NOT SPEAKING.
YOU MAY ALSO RAISE YOUR HAND AND
WE'LL CALL ON YOU.
NEIL ROBERTS WILL HELP WITH THE
MUTING AND UNMUTING ESPECIALLY
WITH VOTES.
IF YOU NEED COMPUTER SUPPORT OR
HELP WITH THE ELECTRONIC COUNCIL
BOOK OR ECB DURING THE MEET,
PLEASE ALSO E-MAIL MELINDA WITH
YOUR REQUEST FOR HELP.
I'D ALSO LIKE TO REMIND YOU
ABOUT UPCOMING CONFLICT OF
INTEREST REPORTING DATES.
UPDATES ARE REQUESTED IN JUNE,
OCTOBER AND FEBRUARY.
WHEN YOU RECEIVE THE REQUEST YOU
MUST RESPOND WITHIN 30 DAYS IN
ORDER TO PARTICIPATE IN THE ANY
COUNCIL-RELATED ACTIVITIES.
AND I'D LIKE TO TURN NOW TO THE
CONSIDERATION OF OUR MINUTES.
WE'LL TAKE A VOTE SO COUNCIL
MEMBERS PLEASE MAKE SURE YOU'RE
UNMUTED AND I'LL GIVE EVERYBODY
A MOMENT TO UNMUTE.
YOU'VE ALREADY SEEN THE MINUTES
OF THE FEBRUARY 1, 2022 COUNCIL
MEETING.
WE POSTED THOSE IN THE
ELECTRONIC COUNCIL BOOK FOR YOU.
DOES ANYONE HAVE COMMENTS OR
CORRECTIONS FOR THE MINUTES?
HEARING NONE MAY I HAVE A MOTION
TO APPROVE.
>> I MAKE A MOTION TO APPROVE.
>> SECOND.
>> ALL RIGHT.
ALL IN FAVOR SAY AYE.
OPPOSED?
MOTION PASSES, THANK YOU,
EVERYONE.
I'D LIKE TO REMIND YOU THE DATES
OF FUTURE COUNCIL MEETING
ALREADY IN THE ECB.
I'M SORRY?
>> THAT WAS ME I'M CLEARING MY
THROAT.
>> NEXT MEETING IS SEPTEMBER 14,
2022.
WE APPRECIATE YOUR PARTICIPATION
SO MAKE SURE THE DATES ARE IN
YOUR CALENDAR.
I'LL QUICKLY GO OVER THE 2023
DATES.
OUR MEETINGS WILL BE JANUARY 31,
JUNE 6th AND AUGUST 29.
AGAIN THE DATES ARE ALREADY IN
THE ECB FOR YOU.
SO YOU CAN PUT THEM IN YOUR
CALENDARS.
DR. CRISWELL BACK OVER TO YOU
NOW.
>> MARK, IF YOU CAN PULL THE
SLIDES.
I'VE DIVIDED MY REPORT INTO
THREE SECTIONS.
FIRST I'LL REVIEW THE NIH AND
NIAMS BUDGETS FOR FISCAL YEARS
2022 AND 2023 AND THEN REVIEW
PERSONNEL CHANGES AT ALL LEVELS
OF THE EXECUTIVE BRANCH RANGE
FROM THE OFFICE OF THE PRESIDENT
DOWN TO NIAMS AND HIGHLIGHT NIH
AND NIAMS ACTIVITIES AND PLANS.
BEGINNING WITH THE BUDGET.
PRESIDENT BIDEN SIGNED THE
FISCAL YEAR 2022 BUDGET FOR NIH
INTO LAW IN MARCH.
AND THE FINAL FUNDING PACKAGE
INCLUDED $45.2 BILLION FOR THE
NIH 5.2% MORE THAN FISCAL YEAR
2021 APPROPRIATIONS.
THE AMOUNT FOR NIAMS WAS $656
MILLION WHICH REPRESENTS A 3.4%
INCREASE OVER FISCAL YEAR 2021
APPROPRIATIONS.
OF COURSE NIH AND NIAMS ARE
GRATEFUL FOR THE BIPARTISAN
SUPPORT THAT ALLOWED THESE
INCREASES.
I WANT TO YOUR ATTENTION TO TWO
NIH PROGRAMS LISTED ON THE
SLIDE.
FIRST, THE FISCAL YEAR 2022
BUDGET PROVIDES $1 BILLION IN
FUNDING FOR THE NEW ADVANCED
RESEARCH PROJECTS AGENCY FOR
HEALTH, OR ARPA-H.
THE BUDGET ALSO INCLUDES A
SUBSTANTIAL INCREASE FOR THE
ONGOING NIH PROGRAM HELPING TO
END ADDICTION LONG-TERM OR HEAL
WHICH AS YOU KNOW IS AN
AMBITIOUS TRANSACTION EFFORT TO
SPEED SCIENTIFIC SOLUTIONS TO
STEM THE NATIONAL OPIOID PUBLIC
HEALTH CRISIS.
ON THE NEXT SLIDE, SO BASED ON
THE FINAL BUDGET NUMBERS FOR
NIAMS, WE'VE UPDATED OUR FUNDING
PLAN ON THE WEBSITE WITH AN RO1
PAY LINE FOR MOST INVESTIGATORS
SET AT THE 12th PERCENTILE.
YOU CAN ALSO SEE WE HAVE MORE
GENEROUS PAY LINE FOR ALL ONLINE
APPLICATIONS FROM EARLY STAGE
INVESTIGATORS.
THOSE WILL BE PAID THROUGH THE
17 PERCENTILE.
SO MARCH 28 PRESIDENT BIDEN
RELEASED HIS FISCAL YEAR 2023
BUDGET REQUEST TO THE CONGRESS.
THE AMOUNT REQUESTED IS $62.5
BILLION FOR THE INCREASE.
AN INCREASE OF 38% OVER THE
FISCAL YEAR 2022 BUDGET DUE TO
ARPA-H AND PANDEMIC
REPAIREDNESS.
FOR NAMES THE AMOUNT IS $376
MILLION AN INCREASE OF 3.1%.
I'D LIKE TO NOTE THE NIAMS
BUDGET INCLUDES AN ADDITIONAL
$24 MILLION TO ENHANCE OUR PAIN
AND OPIOID RESEARCH PORTFOLIO.
SUCH PAIN FUNDING WAS FIRST
PROPOSED FOR FISCAL YEAR 2022
AND THOUGH IT WASN'T INCLUDED IN
THE FINAL FUNDING BILL WE'RE
PRIVILEGE TO SEE IT INCLUDED IN
THE LATEST PROPOSAL THEN HOUSE
AND SENATE WILL DEVELOP THEIR
OWN BUDGET PROPOSALS FOR FISCAL
YEAR 2023.
SO NOW ON THE NIH I WAS INVITED
TO CONGRESSIONAL BRIEFINGS WITH
CONGRESSIONAL STAFF.
THE FIRST BRIEFING FOCUSSED
SOLELY ON NIAMS AND THE THEME OF
MY 10-MINUTE PRESENTATION IS HOW
NIAMS RESEARCH TOUCHES EVERY
AMERICAN.
AFTER A BRIEF REVIEW OF THE
DISEASES WITHIN OUR NIAMS
MISSION I WAS ABLE TO GIVE
EXAMPLES OF HOW THE INSTITUTE
COLLABORATES ACROSS THE NIH WITH
ACTIVITIES SUCH AS HEAL AND
ACCELERATING MEDICINES
PARTNERSHIP.
I HIGHLIGHTED EMERGING
RELATIONSHIPS IN MEDICINE AND
DISCOVERED WHAT NIAMS IS DOING
TO GROW THE PIPELINE OF
INVESTIGATORS AS WELL AS THE
IMPORTANCE OF DATA-DRIVEN
DECISION MAKING AND THE
FLEXIBILITY TO RESPOND TO FUTURE
OPPORTUNITIES.
FOLLOWING MY BRIEF PRESENTATION,
WE HAD 20 MINUTES OF ENGAGING
DISCUSSION.
I ALSO PARTICIPATED IN THE
SECOND BRIEFING ALONG WITH
COLLEAGUES FROM THE NATIONAL
INSTITUTE OF ALLERGY AND
INFECTIOUS DISEASES AND NIDDK
AND THE NATIONAL INSTITUTE OF
DENTAL AND CRANIOFACIAL RESEARCH
WHERE WE EACH SPOKE OF WAYS OUR
INSTITUTES ARE ADDRESSING
AUTOIMMUNE DISEASES.
MOST RECENTLY, ON MAY 31,
REPRESENTATIVE BARBARA LEE OF
CALIFORNIA HOSTED A VIRTUAL
ROUNDTABLE DISCUSSION ON LUPUS
FEATURING EXPERTS TO DISCUSS
ADVANCES AND GAPS IN RESEARCH,
CLINICAL CARE, ADVOCACY AND
PATIENT CARE.
THE ROUNDTABLE LASTED
APPROXIMATELY AN HOUR AND
HIGHLIGHTED IMPORTANT TOPICS
RANGE FROM THE PATIENT
EXPERIENCE AND HOW
RHEUMATOLOGISTS APPROACH
DETERMINING THE RIGHT CARE FOR
AN INDIVIDUAL AND WAYS TO
INCREASE DIVERSITY IN TRIALS SO
THE COHORTS MORE CLOSELY
REPRESENT THE COMMUNITIES
AFFECTED BY LUPUS AND THAT'S OF
GREAT IMPORTANCE AND HIGH
PRIORITY OF CONGRESS WOMAN LEE.
I WAS ABLE TO HIGHLIGHT SOME
RESEARCH.
I WAS ALSO ABLE TO HIGHLIGHT
SIGNIFICANT ADVANCES SUCH AS THE
FINDING THAT MOST WOMEN WHOSE
LUPUS IS WELL CONTROLLED CAN
HAVE A SAFE PREGNANCY AND DETECT
A BIOMARKER FOR HEART DISEASE IN
AFRICAN AMERICAN LUPUS PATIENTS
AND LOOK AT THE COMMITMENT OF
IMPROVING THE LIFE OF AFRICAN
AMERICAN WOMEN AND OTHER
MINORITY WOMEN BY MENTIONING OUR
2021 NIAMS COALITION AND
OUTREACH MEETINGS FOCUS INCLUDED
A SESSION ON IMPROVING DIVERSITY
IN CLINICAL TRIALS.
SO I NOW WANT TO SWITCH GEARS
AND TALK ABOUT SOME PERSONNEL
CHANGES.
I BEGIN WITH THE OFFICE OF THE
PRESIDENT.
SO ON FEBRUARY 16, PRESIDENT
BIDEN ANNOUNCED THAT DR. NELSON
WILL DIRECT THE WHITE HOUSE
OFFICE OF SCIENCE AND
DR. FRANCIS COLLINS WILL BECOME
THE ACTING SCIENCE ADVISER AND
CO-CHAIR OF THE PRESIDENT'S
COUNCIL ADVISER ON SCIENCE.
THESE POSITIONS WILL BE HELD
UNTIL PERMANENT LEADERSHIP IS
NOMINATED SAND CONFIRMED.
DR. COLLINS IS WELL KNOWN TO US
BUT DR. NELSON WHO YOU'RE
PROBABLY NOT FAMILIAR WITH IS A
SOCIOLOGIST BY TRAINING WHO
PLAYED A KEY ROLE IN LOOKED AT
INITIATIVES TO RESTORE TRUST IN
GOVERNMENT AND ADVANCE RACIAL
EQUITY.
SHE'S BEEN SERVING AS THE OSTP
DEPUTY DIRECTOR FOR SCIENCE AND
SOCIETY.
I WANTED TO SHARE WITH YOU ALSO
IN FEBRUARY THE SENATE CONFIRMED
DR. ROBERT CALIF AS COMMISSIONER
HE HELD THE ROLE UNDER PRESIDENT
OBAMA FROM FEBRUARY 2016 TO
JANUARY 2017.
AND LAST MONTH, HEALTH AND HUMAN
SERVICES SECRETARY JAVIER
BECERRA ESTABLISHED ARPA-H AS AN
IN DEPENDENT ENTITY AND
DR. RUSSELL AS THE ACTING DEPUTY
DIRECTOR.
HE'LL BEGIN HIS NEW ROLE THIS
MONTH COMES FROM THE UNIVERSITY
OF MARYLAND'S APPLIED RESEARCH
LABORATORY FOR INTELLIGENCE AND
SECURITY.
IMPORTANTLY, HE SPENT MORE THAN
A DECADE AS A PROGRAM MANAGER
FIRST AT THE INTELLIGENCE
ADVANCE RESEARCH PROJECTS AGENCY
OR I-ARPA-H AND AT THE THE
DEFENSE PROJECT AGENCY OR DARPA.
AT THE NIH, THE NATIONAL CANCER
INSTITUTE'S DIRECTOR, DR. NED
SHARPLESS STEPPED DOWN AFTER
LEADING THE INSTITUTE FOR MORE
THAN FOUR YEARS AND NCI
PRINCIPAL DIRECTOR IS ONCE AGAIN
THE ACTING DIRECTOR, DR. LOWEY
SERVING FOLLOWING THE DEPARTURE
OF DR. BARMIS AND SERVED WHILE
DR. SHARPLESS WAS ACTING
COMMISSIONER OF THE U.S. FOOD
AND DRUG ADMINISTRATION.
SO NOW COMING TO NIAMS PERSONNEL
CHANGES.
NIAMS CONGRATULATES MR. RICK
PHILLIPS THE ASSOCIATE DIRECTOR
FOR MANAGEMENT AND OPERATIONS.
HE'S BEEN THERE SINCE AUGUST
2019.
AND DURING THIS RICK HAS ASSUMED
NUMEROUS DUTIES TO KEEP NIAMS
RUNNING SMOOTHLY DURING THESE
CHALLENGING TIMES, TWO YEARS OF
A PANDEMIC AND THE SOCIAL UNREST
IN THE COUNTRY THAT LED TO THE
POSITIVE OUTCOMES OF THE
NIH-WIDE UNITE INITIATIVE AND
CULTURE COMMUNITY.
ON A PERSONAL NOTE I WANT TO
THANK RICK FOR HIS TREMENDOUS
SUPPORT THROUGH MY ONBOARDING
PROCESS AS NIAMS DIRECTOR.
ADDITIONAL CHANGES AT NIAMS.
WE WELCOME THE ACTING DIRECTOR
OF DIVISION OF EXTRAMURAL
ACTIVITIES, DR. EDGERTON.
HE WORKED FOR THREE YEARS AS A
GRANTS MANAGEMENT SUPERVISOR TO
THE NATIONAL CANCER INSTITUTE
AND THEN RETURNED TO NIAMS AS
THE DEPUTY CHIEF UNTIL PROMOTED
TO THE BRANCH CHIEF.
WHILE ERIK FULFILLS HIS
RESPONSIBILITIES, MS. RAIS IS
NOW ACTING CHIEF GRANTS
MANAGEMENT OFFICER.
SHE JOINED US IN JUNE 2020.
SHE'S WORKED IN THE FIELDS OF
GRANTS MANAGEMENT, POLICY AND
COMPLIANCE WITHIN THE FEDERAL
GOVERNMENT AND THE COMMUNITY FOR
THE PAST 15 YEARS.
WE'RE DEEPLY GRATEFUL FOR THEIR
SUPPORT AND FOR TAKING ON THE
NEW RESPONSIBILITIES.
ON THE NEXT SLIDE I ALSO WANTED
TO SHARE WITH YOU IN OUR
DIVISION OF EXTRAMURAL RESEARCH
WE WELCOME DR. REBECCA LINDSEY
AS A NEW PROGRAM DIRECTOR.
SHE PREVIOUSLY SERVED IN THE NIH
OFFICE OF STRATEGIC COORDINATION
WHERE SHE WORKED IN PROGRAM
MANAGEMENT, EVALUATION AND
COMMUNICATION ROLES FOR SEVERAL
TRANS-NIH COMMON FUND PROGRAM
INCLUDING THE MOTOR PACK
CONSORTIUM NIAMS CO-LEADS WITH
THE NATIONAL INSTITUTE OF AGING
AND THE NATIONAL INSTITUTE OF
DIABETES AND DIGESTIVE AND
KIDNEY DISEASES, NIDDK.
WE ALSO HAVE FAREWELLS AND WE
HAVE A RETIREMENT OF NANCY
GARRICK AND MS. LABBE STEPPED IN
TEMPORARILY.
AND DR. DERR ALSO RETIRED FROM
FEDERAL SERVICE.
MS. CINDY CAUGHMAN DEPARTED FOR
A NEW POSITION AT THE NATIONAL
HEART, LUNG, BLOOD INSTITUTE AND
DR. BURROWS AND DR. DRUGAN ARE
CO-ACTING BRANCH CHIEFS WHILE
THEY COMPETE FOR THE POSITION.
AND LASTLY, DR. ARUNKUMAR WHO
LEFT NIAMS TO BECOME A PROGRAM
OFFICER AT THE NATIONAL
INSTITUTE ON AGING.
SO WE WISH ALL OF THEM THE BEST
IN THEIR NEW ENDEAVORS.
SO ON NEXT SLIDE, I WANTED TO
SHARE WITH YOU NA NIAMS IS
BEGINNING A FORMAL REVIEW OF
LEADERSHIP AND EFFECTIVENESS A
PROCESS THAT IS SUPPOSED TO
OCCUR FOR EACH INSTITUTE AND
CENTER EVERY SIX YEARS.
DR. JOHN O'SHEA ADDRESSED THE
COUNCIL IN FEBRUARY AND HAS BEEN
SERVING AS SCIENTIFIC DIRECTOR
SINCE 2006.
HIS UPCOMING REVIEW WILL OCCUR
OVER THE NEXT EIGHT MONTHS AND
WILL INCLUDE INPUT FROM A
COMMITTEE THAT WILL INCLUDE
MEMBERS FROM THIS COUNCIL AND
ULTIMATELY, THAT AD HOC REVIEW
COMMITTEE WILL PRESENT ITS
REPORT TO YOU THE NIAMS ADVISORY
COUNCIL AT THE JANUARY 2023
MEETING.
I WANTED TO PROVIDE YOU UPDATES
ON THE NIH AND NIAMS POLICIES
AND PROGRAMS.
AS YOU KNOW SCIENCE EXCHANGES
RAPIDLY AND SO THE NIH CENTER
FOR SCIENTIFIC REVIEW HAS A
PROCESS BY WHICH IT REVIEWS
STUDY SECTIONS TO DETERMINE
WHETHER CHANGES IN FOCUS OR
SCOPE ARE NEEDED TO FACILITATE
THE IDENTIFICATION OF HIGH
IMPACT SCIENCE PARTICULARLY WITH
RESPECT TO EMERGING AREAS.
SO THIS PROCESS IS KNOWN AS THE
EVALUATING PANEL QUALITY AND
REVIEW OR N QUIRE TO ASSESS
CLUSTERS AROUND SCIENTIFIC
TOPICS.
ONE FOCUSSED ON POPULATION
HEALTH AND EPIDEMIOLOGY AND THE
NAME SECTION AS THE NEUROLOGICAL
AGING AND MUSCULOSKELETAL
EPIDEMIOLOGY STUDY SECTION.
AS AN OUTCOME OF THE PROCESS,
NAME IS BEING DISBANDED AND A
NEW STUDY SECTION CALLED AIMR
WHICH STANDS FOR AGING, INJURY,
MUSCULOSKELETAL AND
RHEUMATOLOGIC DISORDERS WILL
START THIS FALL FOR UPCOMING
MAY/JUNE, 2022 APPLICATION DUE
DATES.
I ALSO WANTED TO SHARE THAT NIH
IS IMPLEMENTING A GENERAL
PROVISION IN THE 2022
CONSOLIDATED APPROPRIATIONS ACT
THAT MAKES REPORTING TO NIH BY
NIH-FUNDED INSTITUTIONS
MANDATORY WHEN INDIVIDUALS
IDENTIFIED AS A PRINCIPLE
INVESTIGATOR OR AS KEY PERSONNEL
IN AN NIH NOTICE OF AWARD
REMOVED FROM THEIR POSITION OR
OTHERWISE DISCIPLINED DUE TO
CONCERNS ABOUT HARASSMENT,
BULLYING, RETALIATION OR HOSTILE
WORKING CONDITIONS.
PREVIOUSLY, NIH LACKED CLEAR
AUTHORITY TO REQUIRE FUNDED
INSTITUTION TO REPORT WHEN
PERSONNEL CHANGES TO AN NIH
GRANT ARE RELATED TO HARASSMENT.
SO THIS NEW PROVISION IS
INTENDED TO ENSURE CONGRESS IS
AWARE OF THIS PROVISION OR IT
ENSURES NIH IS AWARE WHEN THE
REASON FOR THE PERSONNEL CHANGES
IS HARASSMENT AND THE GOAL IS TO
STRENGTHEN THE NIH ABILITY TO
ENSURE SAFE WORK ENVIRONMENTS
WHEREVER NIH-FUNDED WORK TAKES
PLACE.
THIS POLICY GOES INTO EFFECT
JANUARY 9 AFTER WHICH TIME
GRANTEE INSTITUTIONS WILL HAVE
30 DAYS TO NOTIFY THE NIH WHEN
SUCH DISCIPLINARY ACTION OCCURS.
AND WHEN THE FUNDED INSTITUTION
REPORTS HARASSMENT TO THE NIH,
THE AGENCY WILL WORK WITH THE
GRANTEE ORGANIZATION AS WELL AS
OTHER FEDERAL ENTITIES AS
REQUIRED TO DETERMINE WHAT
ACTIONS ARE APPROPRIATE.
NIH'S RESPONSE MAY INCLUDE
IMPROVING THE SUBSTITUTION OR
REMOVAL OF A PERSONNEL FROM AN
NIH GRANT, RESTRICTING AWARD
FUNDING OR IN RARE CIRCUMSTANCES
SUSPENDING OR TERMINATING THE
AWARD.
NIH ALSO REACHED ANOTHER
MILESTONE WITH THE ACCELERATING
MEDICINE THE AMP RESEARCH
PROGRAM.
HEARD ABOUT THE RHEUMATOID
ARTHRITIS AND DISEASES COUNCIL
MEETING.
IN MARCH, THE NIH AWARDED GRANTS
TO NINE RESEARCH GROUPS ACROSS
THE UNITED STATES TO ESTABLISH
THE AMP AIM NETWORK.
IN ADDITION TO RA AND LUPUS IT
INCLUDES PSORIASIS AND SJOGREN'S
DISEASE AND DISCOVERING HOW
CELLS OF THE INNATE AND ADAPTIVE
IMMUNE SYSTEM AND CELLS CAUSE
INFLAMMATION AND DISEASE AND
HOPEFULLY ACCELERATE THE
THERAPEUTIC TARGETS.
I'VE SHARED WITH YOU THE NINE
AWARDS AND THE DISEASE TEAMS
WILL LEAD THE RESEARCH EFFORTS
TO DEFINE THE MOST SIGNIFICANT
SCIENTIFIC OPPORTUNITIES THAT
CAN BE ADDRESSED WITH STATE OF
THE ART AND NEXT GENERATION
TISSUE TECHNOLOGIES IN THE
CONTEXT OF AIM.
ON THE NEXT SLIDE, WE'VE LIST
THE CORE RESOURCES PART OF THE
PROGRAM.
THIS SLIDE SHOWS THE TWO SYSTEMS
BIOLOGY CORES AND THE TISSUE
RESIDENT COUR WITH THE P.I.s AT
THOSE INSTITUTIONS.
THE NEXT SLIDE SHOWS THE TWO
TECHNOLOGY CORES FUNDED.
ONE FOCUSSED ON SINGLE CELL AND
SPATIAL GENOMIC ANALYSES AND
OTHER FOCUSSED ON THE MICROBIOME
TO APPLY STATE OF THE ART AND
NEXT DIMENSIONAL, HIGH
RESOLUTION TECHNOLOGY TO ANALYZE
HUMAN BIOPSY TISSUE AND BIO
SPECIMENS FROM PATIENTS.
SO I WANTED TO TAKE THE SLIDE TO
REMIND YOU OF THE LIST OF
RESEARCH PUBLICATIONS WE'VE
INSERTED IN THE ELECTRONIC
COUNCIL BOOK.
WE DO THIS PRIOR TO EACH COUNCIL
MEETING.
I ALSO WANT TO REMIND YOU THAT
WHILE THE LISTING IS NOT A
COMPREHENSIVE COLLECTION OF ALL
THE OUTSTANDING PUBLICATIONS
RESEARCHERS HAVE PRODUCED, IT
DOES HIGHLIGHT NIAMS SUPPORTED
ADVANCED IDENTIFIED BY OUR
EXTRAMURAL PROGRAM STAFF AND
INTRAMURAL INVESTIGATORS OF
BEING OF PARTICULAR INTEREST.
SO I WANTED TO FEATURE ONE TODAY
THAT'S RELEVANT TO AMP.
THE AMP NETWORK THAT COMES FROM
A PUBLICLY AVAILABLE DATA SET
GENERATE FROM THE RHEUMATOID
ARTHRITIS COHORT OF THE AMP RA
AND LUPUS NETWORK.
A RESEARCH TEAM LED BY
DR. BRENNER AT BRIGHAM AND
WOMEN'S HOSPITAL AND HARVARD
MEDICAL SCHOOL IN BOSTON
DEMONSTRATED A MOLECULE CALLED
SLAMF7 TRIGGERS EXCESSIVE
PRODUCTION OF PROINFLAMMATORY
THAT SUPER ACTIVATE MACROPHAGES
IN THE JOINTS OF PATIENTS WITH
RHEUMATOID ARTHRITIS.
BECAUSE SLAM F7 WERE NOT ONLY
SEEN IN MACROPHAGES FROM R.A.
PATIENTS AND SEEN IN GUT
MACROPHAGES FROM PATIENTS WITH
CROHN'S DISEASE AND PATIENTS THE
INVESTIGATORS PROPOSE THE MACRO
PHAGE DYSREGULATION MAY PLAY A
ROLE AND THERAPEUTIC AGENT MAY
REDUCE THE SEVERITY OF R.A.
SYMPTOMS.
SUCH AGENTS HAVE BEEN SHOWN TO
REDUCE THE SEVERITY IN ANIMAL
MODELS OF R.A.
THIS POTENTIAL IN
TREATING HUMAN DISEASE.
ON THE NEXT SLIDE I LOOK FORWARD
TO UPDATING YOU IN SEPTEMBER
ABOUT THE AMP BESPOKE GENE
THERAPY CONSORTIUM.
IT'S TO STREAMLINE GENE
THERAPIES FOR RARE DISEASES AND
WE'RE EAGERLY AWAITING WHICH
CONDITIONS WILL BE SELECTED AND
WE'LL HEAR VERY SOON.
NIAMS AWARDED TWO OF THE EARLY
STAGE RO1 GRANTS.
THE AWARD PROVIDES A NEW PATHWAY
FOR EARLY STAGE INVESTIGATORS
WHO WISH TO PROPOSE RESEARCH
PROJECT IN A NEW DIRECTION FOR
WHICH PRELIMINARY DATA DO NOT
EXIST.
AND AS I THINK YOU'RE AWARE,
IT'S NAMED AFTER THE FORMER
DIRECTOR OF NIAMS, WHO WAS A
STRONG ADVOCATE FOR EARLY STAGE
INVESTIGATORS.
MANY INSTITUTES AND CENTERS HAVE
SIGNED ON SO EXCITED ABOUT THE
OPPORTUNITY FOR INVESTIGATORS.
THE INSTITUTE IS BEGINNING TO
SHARE FISCAL PLANS FOR YEARS
2025 THROUGH 2029.
THE NEW PLAN WILL REFLECT THE
RECOMMENDATIONS FROM COUNCIL
WHEN WE DEVELOPED OUR CURRENT
PLAN SUCH AS THE IMPORTANCE OF
HAVING A BOLD, AMBITIOUS VISION
FOR THE NIAMS VISION OVER THE
NEXT HALF DECADE.
WE ALSO RECOGNIZE THE IMPORTANCE
OF ENGAGING COUNCIL EARLY IN THE
PROCESS AND WE'LL BE CALLING ON
YOU TO PROVIDE INPUT YOURSELVES
AND ALSO TO HELP GATHER INPUT
FROM THE BROADER SCIENTIFIC AND
PATIENT COMMUNITIES.
BUILDING ON THE STRUCTURE OF OUR
PREVIOUS PLAN, WE EXPECT TO
ORGANIZE THE DOCUMENT AROUND
CROSS-CUTTING SCIENTIFIC THEMES
THAT WILL RESONATE WITH ALL
INTERESTED IN MUSCLE, JOINT,
SKIN AND RHEUMATIC DISEASES.
BEFORE OPENING THE FLOOR FOR
DISCUSSION, I WANT TO GIVE THREE
OF OUR EXTRAMURAL PROGRAM
OFFICERS A CHANCE TO UPDATE YOU
ON PROJECTS THEY'VE BEEN WORKING
ON.
FIRST, FROM DR. NISM LEADING THE
WORKSHOP ON HEALTH DISPARITIES
AND OSTEOARTHRITIS.
>> THANK YOU, DR. CRISWELL.
THIS WORKSHOP WILL BE JUNE 7.
FOR THOSE WHO HAVE INTEREST IN
TAINEDING THE WORKSHOP WILL
FOCUS ON COMBINING BEHAVIORAL
AND BIOMEDICAL SCIENCE TO
ADDRESS PERSONAL, INTRAPERSONAL
AND INFLUENCE CONTRIBUTE TO
HEALTH DISPARITIES
OSTEOARTHRITIS AND WE'LL HAVE
BREAKOUT SESSIONS.
THE PURPOSE OF THE WORKSHOP IS
TO BRING TOGETHER EXPERTS IN
HEALTH DISPARITY TO CHANGE IDEAS
REGARDING HOW AND WHY
DISPARITIES IN O.A. TREATMENT
OUTCOMES AND ACCESS TO CARE
EXIST AND HOW THEY CAN BE
ADDRESSED.
OUR VIRTUAL WORKSHOP WILL BE
HELD JUNE 12 AND 13th AT 11:00
A.M. EASTERN EACH DAY.
I HIGHLIGHTED IMPORTANT AGENDA
ITEMS FROM EACH DAY.
FOR MORE DETAILED INFORMATION
VISIT THE WORKSHOP WEBSITE AT
THE PROVIDED LINK AS WELL AS
THROUGH OUR MEETINGS AND EVENTS
INFORMATION ON THE NIAMS
WEBSITE.
FULL PARTICIPATION IS LIMITED SO
YOU WILL NEED TO REGISTER BUT
THE WORKSHOP WILL BE VIDEOCAST
FOR THOSE WHO WOULD TO LISTEN.
WE'RE HOPEFUL FOR AN EXCITING
WORKSHOP WITH ROBUST
PARTICIPATION TO BE LED BY OUR
CO-CHAIRS, ARLENE F. BROWN, LEE
CALLAHAN, AND OTHERS AND THEY
HAVE EXPERTISE AND ADVICE TO OUR
PLANNING GROUP THAT INCLUDES
STAFF NOT ONLY FROM THE NIAMS
AND OTHER INSTITUTES WITH
INTEREST IN HEALTH DISPARITIES.
WE HOPE TO SEE YOU AT THE
WORKSHOP.
>> NEXT, WE'LL HEAR ABOUT THE
INSTITUTE PLANS ON ROUNDTABLE ON
CARTILAGE PRESERVATION IN KNEE
OSTEOARTH
OSTEOARTHRITIS.
>> I'D LIKE TO GIVE YOU A QUICK
UPDATE AND THE TITLE IS
CARTILAGE RESTORATION AND I'M
THE PROGRAM DIRECTOR OF THE
CLINICAL OSTEOARTHRITIS
PORTFOLIO.
REGENERATIVE MEDICINE IS AN
EMERGING AREA OF SCIENCE THAT
PROMISES TO TREAT AND CURE A
VARIETY OF DISEASES SUCH AS KNEE
OSTEOARTHRITIS.
BIOLOGICS INCLUDING INJECTION OF
PRP AND MARROW OR TISSUE-DERIVED
STEM CELLS HAVE BEEN USED AS
TREATMENT TECHNOLOGY IN PATIENTS
WITH KNEE OSTEOARTHRITIS.
THERE'S CONCERNS ABOUT THE
INFORMATION FROM THE DIRECTOR
CONSUMER MARKETING OF TREATMENT
AND RESEARCH NEEDS TO BE DONE TO
REALIZE THE FULL OF REGENERATIVE
MEDICINE INCLUDING BIOLOGICS AS
TREATMENT FOR OSTEOARTHRITIS.
AND FDA PUBLISHED NEW GUIDANCE
ON CELL AND TISSUE PRODUCT IN
JULY 2020 WITH STRICTER INT
INTERPRETATION OF CRITERIA FOR
CELL-BASED THERAPY FROM THE FDA.
MANY CELL-BASED THERAPY WILL BE
TREATED DIFFERENTLY.
THE TARGET IS TO IDENTIFY
CHALLENGES, GAPS AND
OPPORTUNITIES RELATED TO
MEDICINE AND TO DEFINE WHAT
RESEARCH IS NEEDED TO REALIZE
THE FULL POTENTIAL.
QUESTIONS TO BE DISCUSSED AT THE
ROUNDTABLE INCLUDE WHAT EVIDENCE
SUPPORTS THE SAFETY AND ADVOCACY
OF THE CLINICAL USE OF
REGENERATIVE MEDICINE AS THERAPY
FOR KNEE OSTEOARTHRITIS.
WHAT APPROACH AND AREAS OF BRING
NEW OPPORTUNITIES FOR CARTILAGE
PRESERVATION AND RESTORATION.
THE MAIN CHALLENGES AND GAPS OF
THE EMERGING OPPORTUNITY.
WHAT CAN BE DONE BY NIAMS TO
FACILITATE PROGRESS IN THIS
AREA?
IT'S A ONE-DAY VIRTUAL MEETING
AND WILL BE BROADCAST LIKE THIS
ONE WHERE NIH VIDEOCAST SYSTEM.
IT INCLUDES PRESENTATION ON
SELECT TOPICS AND ALSO PANEL
DISCUSSION WE INVITED EXPERTS
FROM DIVERSE BACKGROUND AND
CAREER STATUS.
MANY ARE NIAMS INVESTIGATORS.
WE HAVE AN INTRAMURAL
INVESTIGATORS AND REPRESENT FROM
FDA AND PATIENTS.
THE MEETING WILL BE CHAIRED BY
WILL DR. CRISWELL AND CO-CHAIRED
BY DR. CHU FROM STANFORD AND IT
IS ANNOUNCED ON THE NIAMS
WEBSITE.
I WANT TO THANK MY COLLEAGUE WHO
HELPED WITH THE PREPARATION OF
THE ROUNDTABLE.
THANK YOU.
>> GREAT, THANK YOU, TED AND
THANK YOU SO MUCH FOR ALL THE
WORK YOU'VE DEVOTED ALONG WITH
YOUR COLLEAGUES TO PREPARING FOR
THE UPCOMING EVENT.
LOOKING FORWARD TO IT.
THIS HAS BEEN A TOPIC MANY
COUNCIL MEMBERS ARE INTERESTED
IN.
REALLY EXCITE ABOUT THAT.
OUR FINAL PRESENTATION AS PART
OF THIS OPENING SESSION WILL BE
BY DR. FAYE CHEN TO TELL US
ABOUT AN EVALUATION OF
INSTITUTES R21 PORTFOLIO AND PRE
OPPOSED CHANGES TO OUR
PARTICIPATION IN THE NIH WIDE
PROGRAM.
FAYE.
>> THANK YOU, DR. CRISWELL.
GOOD MORNING, EVERYONE.
SO I'M REPRESENTING THE NIAMS
WORKING GROUP IN GIVING THIS
REPORT AND WE THANK YOU,
DR. CRISWELL FOR THE OPPORTUNITY
TO PRESENT TO THE COUNCIL
MEMBERS.
AS DR. CRISWELL SAID, THE
DISCUSSION TODAY IS ABOUT
WHETHER NIAMS CONTINUE TO ISSUE
R21 FUNDING OPPORTUNITY
ANNOUNCEMENT THROUGH THE NIH FOA
FUNDING OPPORTUNITY
ANNOUNCEMENT.
IF SO, SHOULD WE DO IT THROUGH
THE TRADITIONAL WAY OR OUR OWN
AND THE REASON WHY WE EXAMINED
THIS ISSUE WILL BECOME CLEAR
LATER.
THE MECHANISM IS TWO YEARS WITH
$275,000 DIRECT COST FOR TWO
YEARS TO ENCOURAGE EXPLORATORY
AND DEVELOPMENT PROJECTS AND
THERE'S AN EMPHASIS IN
INNOVATION.
SINCE THIS IS AN FOA, INSTITUTE
CENTERS AND OFFICES OR ICO
FUNDING AUTHORITIES CAN
PARTICIPATE BUT FOR SOME REASONS
ICOs CHOOSE NOT TO.
THIS DOES NOT NECESSARILY MEAN
THEY DON'T USE THE MECHANISM.
THEY MAY ISSUE THEIR OWN FOA FOR
R21s WITHOUT SIGNING ON TO THE
PARENT FOA AND THIS GIVES US THE
OPPORTUNITY TO EXAMINE OUR OWN.
THE ICOs WITH FUNDING WE CAN SEE
THAT THE NUMBER OF ICOs
PARTICIPATING IN THE PARENT R21
FOA VARY.
THE TREND IN RECENT YEARS IS
THAT SOME ICOs HAVE DECIDED TO
BLOCK OUT AND WE FOUND SOME
I.C.s MOVE IN AND OUT OF THE
COMPETING FOA.
ON THE RIGHT SIDE WE SHOW THE
NIH ICOs NOT PART OF THE PARENT
R21 FOA IN 2022.
THE ONES IN RED ARE THE I.C.s
WHO SHARED OVERLAPPING RESEARCH
INTERESTS WITH NIAMS.
AND SOME OF THE EXAMPLES ARE
SHARED INTEREST AREAS ARE ALSO
SHOWN HERE.
SO WHAT IS THE IMPLICATION?
WHEN AN APPLICATION IS SUBMITTED
TO NIH, THE CENTER FOR
SCIENTIFIC REVIEW WILL TRY THEIR
BEST TO FIND A HOME FOR IT.
WHEN AN R21 APPLICATION IS
SUBMITTED TO A NON-PARTICIPATING
I.C., THEY'LL THEN CONTACT
PARTICIPATING I.C.s WITH
OVERLAPPING RESEARCH INTEREST
AND SOMETIMES THEY END UP
ACCEPTING AND EVENTUALLY FUNDING
THE APPLICATIONS.
THIS COULD BENEFIT OTHER
INSTITUTES.
WE LOOKED AT AVERAGE AWARD RATES
AND OUR EFFOSTIMATE IS IT THEY E
UP 3% TO 6%.
SOME PORTFOLIOS ARE MORE
EFFECTIVE THAN OTHERS.
IN ADDITION THEY CONTEMPLATE THE
PARTICIPATION IN THE PARENT FOA
AND IF THAT IS THE CASE THE
QUESTION IS SHOULD WE ISSUE OUR
OWN.
WE ANALYZED THE RESEARCH OF THE
PARENT FOA AND NIAMS
INVESTIGATORS AND OUTCOMES.
THIS SHOWS THE TREND OF
COMPETING AWARDS IN BLUE AND
YELLOW.
YOU CAN SEE THE NUMBER OF RO1
AWARDS REMAINS STABLE AND
COMPETING ONES.
NIAMS HAS NEW AWARDS IN FISCAL
YEAR 2021 COMPARED TO 39.
BUDGET WISE THE STABLE NIAMS
AWARDS FOR FY2021, RO1 AWARDS
REPRESENT 49% AND THE BUDGET IS
SMALLER AND REPRESENTS ABOUT
4.9% OF NIAMS BUDGET.
AND THE RIGHT SIDE WE LOOKED AT
HOW MUCH THEY USED THE PARENT
MECHANISMS.
FOR INVESTIGATORS WHO HAVE
APPLIED FOR ANY NIAMS MECHANISMS
IN FY2021, 21% OF THEM APPLIED
FOR THE PARENT AND 43%.
OVERALL, RESULTS OF THIS SLIDE
SUGGEST TO US A STRONG INTEREST
OF INVESTIGATORS.
IT'S SUPPORTING INNOVATIVE
PROJECTS.
WE WANTED TO ASSESS IF THE NIAMS
CURRENT R21s ARE MEETING THIS
GOAL.
SO WE LOOKED AT HOW STUDY
SECTION REVIEWERS SCORED FOR THE
REVIEW CRITERIA OF INNOVATION.
WE USED AN ACCEPTED METHOD THAT
WAS USED BEFORE TO ANALYZE NIH
R01s TO DETERMINE WHICH REVIEW
CRITERIA BETTER PREDICT THE
FINAL.
WITH LOOKED AT INDIVIDUAL
CRITERIA SCORES.
COMPARED TO RO1 THE R21
INNOVATIONS SHOW STATISTICALLY
STRONGER ASSOCIATION.
MULTIPLE REGRESSION ANALYSIS IS
SHOWN ON THE RIGHT.
THIS WAS FOUND TO SEE HOW MUCH
SCORE CONTRIBUTES TO THE FINAL
SCORE SHOWN AT THE BOTTOM.
FOR R21s, THE INNOVATION VERSUS
THIS.
THIS RESULT SUGGESTS WHEN
REVIEWERS OF PARENT R21 GET
VALUE FOR INNOVATION MORE THAN
THE RO1s.
THE CONCLUSION HERE IS THAT IN
OUR VIEW, THE PARENT R21 IS AT
LEAST PARTIALLY FULFILLING ITS
GOAL.
FOR THIS ANALYSIS, WE ASK
WHETHER R21 IS A GOOD INVESTMENT
AND LOOKED AT PUBLICATIONS.
SINCE THE BUDGET OF R21 AND RO1s
ARE DIFFERENT WE NORMALIZE BY
THEIR TOTAL.
SO FOR BOTH SUBMITTED AND
GRANTED PATTERNS R21 HAS AN
ADVANTAGE.
THIS IS TRUE FOR PUBLICATION.
SO OUR RESULTS HERE SUGGEST
NIAMS IS MAKING A GOOD
INVESTMENT ON THE PARENT R21
WOULD THE CAVEATS OF THE
ANALYSIS.
SO WE HAVE SHOWN DATA SUGGESTING
THE VALUE OF NIAMS USING THE
PARENT SO THE WORKING GROUP
RECOMMENDS THAT NIAMS SHOULD
CONTINUE TO OFFER THE R21
MECHANISM TO ITS INVESTIGATORS.
WE SHOWED APPLICATION SHOULD
BENEFIT OTHER NON PARTICIPATING
I.C.s.
THOUGH THE BUDGET IS RELATIVELY
SMALL, WE DO WANT TO FOCUS OUR
FUNDING TO FOUR NIAMS MISSION
AREAS ESPECIALLY IN THE
COMPARATIVE.
THEREFORE THE WORKING GROUP
RECOMMENDED TO FIND WAYS TO
BETTER CONTROL APPLICATIONS.
FOR THIS PURPOSE THE WORKING
GROUP PROPOSES TO RESTORE FROM
THE NIH PARENT R21 FOA AND ISSUE
A NOTICE OF SPECIAL INTEREST FOR
NOSI.
AND THE NIH PARENT R21 AND
FOCUSSING ON NIAMS.
MY CO-CHAIR DR. ZHENG AND I WANT
TO THANK THE WORKING GROUP
MEMBERS FOR THEIR HARD WORK AND
UNL
ANALYSTS AND WE APPRECIATE THE
R21 ANALYSIS AND THANK YOU FOR
YOUR ATTENTION.
OVER DO YOU, DR. CHRIS WELL.
>> I WANT TO APPLAUD THE EFFORTS
OF YOU AND YOUR COLLEAGUES FOR A
CAREFUL LOOK AT THE SPENDING
MECHANISM.
IT REFLECTS TAKING A DATA-DRIVEN
APPROACH AND ALSO OUR
PRIORITIZATION FOR EVERY DOLLAR
WE SPEND TO MAKE SURE WE'RE
INVESTIGATING WISELY.
I APPRECIATED THE FOLLOW-UP
ABOUT THE NOTION OF MISSION
WHICH WAS NOT SOMETHING I WOULD
HAVE THOUGHT ABOUT.
THANK YOU FOR YOUR THOUGHTFUL
ANALYSIS AND PRESENTATION.
NOW, WE HAVE AN OPPORTUNITY FOR
ANYBODY TO RAISE QUESTIONS ABOUT
WHAT FAYE JUST SHARED OR
ANYTHING ELSE THAT'S BEEN
TOUCHED UPON SO FAR IN THE
MEETING.
WE HAVE PLENTY OF TIME SET ASIDE
FOR QUESTIONS AND DISCUSSION AND
FOLLOWING THAT, STARTING AROUND
11:40 EASTERN WE SET ASIDE TIME
FOR NEW TOPICS TO BE RAISED BY
THE COUNCIL MEMBERS.
WE HAVE A LOT OF FLEXIBILITY
ACROSS THOSE TWO SECTIONS AND
HAVE PLENTY OF TIME NOW FOR
QUESTIONS ABOUT THESE TOPICS OR
FOR NEW TOPICS TO BE RAISED.
SO, YES, THANK YOU FOR BRINGING
US BACK TO THE GALLERY VIEW.
I SEE MARY'S HAND UP AND LOUISE'
AS WELL.
>> I HAVE A QUESTION ON THE R21
ANALYSIS.
THANK YOU, FAYE.
THAT WAS THOROUGH AND SUPER
HEFUL TO SEE IT IN THAT CONTEXT.
DO YOU KNOW WHY OTHER INSTITUTES
STOPPED PARTICIPATING AND HAVE
YOU LOOKED AT THE AMOUNTS
AWARDED AND HAVE THEY INCREASED
OVER TIME.
I ALWAYS HEAR THE RO1s AT
$250,000 A YEAR HAVE NOT
REFLECTS INCREASES FOR THE
STANDARD AMOUNTS AND WONDERED IF
ANYONE LOOK AT THAT FOR THE R21
AS WELL.
>> THANK YOU FOR THE QUESTION.
>> THE R21 BUDGET IS FIXED 275K
ACROSS THE TWO YEARS.
THERE'S NO CHANGE THERE.
HOW LONG HAS IT BEEN 275 AND IS
THERE THINKING IT SHOULD BE 325
GIVEN INFLATION.
HOW LONG HAS IT BEEN AT 275 WAS
MY QUESTION.
>> I KNOW IT'S BEEN 275 SINCE
OUR ANALYSIS LOOKING AT R21 AND
I REMEMBER AND WHETHER THERE'S
PLANS TO INCREASE THAT SHOULD BE
AN NIH WIDE DISCUSSION.
THE FIRST QUESTION, WHAT ARE THE
MAJOR REASONS FOR OTHER I.C.s
DECIDING TO JOIN OR MORE
IMPORTANTLY TO NOT BLOCK OUT
THERE WAS ANOTHER R21 ANALYSIS
AND I CAN SHOW THE SLIDE THERE
WAS ONE SLIDE AND THE P.O. IT
SEEMS THE PRIMARY CONCERN WITH
THE RECENT ONES THAT DROPPED OUT
IS THEY WERE RECEIVING ALSO
MISSION CRITICAL APPLICATIONS OR
AWARDING THEM IN RECENT YEARS
ALSO BECAUSE THERE ARE OTHER
I.C.s HAD OVERLAPPING INTERESTS
ALSO DROPPED OUT.
THERE WAS THE PERCEPTION THE R21
WAS NOT MEETING ITS GOAL.
WE LOOKED AT INNOVATION AND THAT
SEEMS TO BE NOT COMPLETELY TRUE
FOR IT'S OTHER REASONS FOR
INSTITUTES WIDE
>> THANK YOU BOTH FOR THE
QUESTION AND RESPONSES.
LUIS.
YOUR NEXT.
>> I HAD A QUESTION WITH R21s.
I THINK WHEN WE PULL OUR
INSTITUTES THE NUMBER ONE THING
IS PAY LINES.
THAT'S WHAT PEOPLE CARE HOW MANY
WITH R21s HAVE RO1s AND HOW MANY
DON'T HAVE ANY OTHER FUNDING.
I WOULD SUGGEST THINKING ABOUT
THE CAREER SUSTAINABILITY MAY
IMPLY A REASON TO THINK ABOUT
PRIORITIZING RO1s I NOTICE IN
THE PAY LINE YOU HAVE DONE THAT
I THINK IT WAS A SMART MOVE AND
A WANT TO EMPHASIZE RIGHT NOW A
PRESENTATION WE WERE AT FOR THE
LOCAL DERMATOLOGY MEETING WAS
TALKING TO YOUNG FOLKS AND IT'S
A CONCERN FOR YOUNG PEOPLE AT
THEY GET THEIR EARLY CAREER
INVESTIGATOR RO1 WHAT WILL
HAPPEN AFTER THAT IS AN ISSUE
FOR MIDCAREER INVESTIGATORS AND
THINKING OF MOVING TOWARDS RO1
MAY SUSTAIN A BEST WORKFORCE FOR
NIAMS.
>> IT'S A GREAT QUESTION.
I'LL SEE IF I CAN ANSWER YOUR
QUESTION.
THE R21 SUSTAINING EARLY CAREER,
I DON'T KNOW EXACTLY WHAT'S THE
BEST WAY TO EVALUATE THAT.
WE DID DO SOME EVALUATION IN OUR
ANALYSES THAT MIGHT POTENTIALLY
ANSWER YOUR QUESTION.
WE LOOKED AT THE R21 AWARDS AND
HOW MANY OF THEM, WHAT'S THE
PERCENTAGE THAT FOLLOW NIH
SUPPORT FOR THE P.I.
AND THAT OVER THE YEARS IT'S
ABOUT 50%.
TO THE ANOTHER ANALYSIS THAT MAY
ADDRESS SOME OF YOUR QUESTION IS
FOR THESE P.I.s WITH SOLE
SUPPORT WAS THEIR CHANCE OF
GETTING A FUTURE RO1.
THE COMPARISON THE CONTROL GROUP
WILL BE THE INVESTIGATORS
WITHOUT ANY OTHER AWARDS.
GENERALLY SPEAKING, OVER THE
YEARS THE P.I.s DO FARE BETTER
IN GETTING A FUTURE RO1
EVENTUALLY.
THAT ADDRESSES SOME OF YOUR
QUESTIONS AND --
>> I WANT TO ADDRESS THE
QUESTION ABOUT WHETHER R21 IS
ENOUGH.
WE DID CONSIDER THIS AND I THINK
IT'S DEPENDENT ON THE SALARY
STRUCTURE OF THE INSTITUTE.
AT SOME INSTITUTES LIKE THE
ENGINEERING ORIENT ED WHERE THE
INVESTIGATORS HAVE SALARY
SUPPORT THROUGHOUT THE YEAR THEY
NEED A SMALLER GRANT TO HIRE A
STUDENT DO A SUMMER RESEARCH OR
YEARLONG RESEARCH AND DON'T NEED
TO DRAW SALARIES.
SO R21 IN THAT SITUATION CAN
SUPPORT AND IS PROBABLY THE
PREFERRED WAY OF SUPPORTING
THOSE RESEARCHERS.
>> WE TRIED TO ADDRESS THAT AND
LOOKING AT THE DEGREE OF THE
P.I. OR WHAT SCHOOLS THEY'RE IN.
>> THIS MEETING IS BEING
RECORDED AND WE'RE TAKING NOTES
AS WELL SO WE DON'T MISS SOME OF
THESE OPPORTUNITIES FOR
FOLLOW-UP ANALYSIS AND REPORTING
BACK.
I APPRECIATE ALL THE COMMENTS.
JOAN WAS NEXT.
>> THAT WAS A NICE PRESENTATION
AND ENCOURAGING DATA AND IF
YOU'RE NOTIFIED BY CSR ANOTHER
INSTITUTE HAS AN APPLICATION
THAT OVERLAPS WITH NIAMS
MISSIONS, DO YOU THEN SINCE WE
HAVE THE PARENT R21 THAT WE'RE
HAPPY WITH, DO WE REJECT THOSE
OR DO WE EVALUATE THEM?
DO WE PROVIDE SOME FUNDING FOR
THEM AND IF SO, WHAT PERCENT OF
OUR R21 BUDGET IS COMPRISED BY
THOSE TYPES OF APPLICATIONS?
>> SO THE GOAL IS TO FIND A HOME
FOR AS MANY APPLICATIONS AS
POSSIBLE.
WHEN THE APPLICATION IS LOOKING
AT AN R21, AND AN AREA FOR
EXAMPLE TRAUMA, SO WE HAVE
OVERLAPPING INTERESTS BECAUSE
THAT IS SOMETHING WITH TRAUMA
MANY OF INDUCED CONDITIONS BUT
WHEN IT'S AN R21 IT'S NOT AN FOA
SO THAT APPLICATION WILL BE SEND
TO NIAMS.
SO NIAMS P.O.s WILL LOOK AT THE
SPECIFIC AIMS AND JUDGE IF
THERE'S NEGOTIATION AND WE JUDGE
IF IT'S 90% NOT WITHIN THE NIAMS
MISSION WE DON'T ACCEPT THAT.
IF IT'S 50% ON THE BORDERLINE,
WE HAVE SYMPATHY FOR
INVESTIGATORS.
SO ON THE BORDERLINE
APPLICATIONS WE TEND TO ACCEPT
AND JUSTIFY IT'S ENOUGH WITHIN
THE NIAMS MISSION.
>> WE PROVIDE COMPLETE OR SHARED
FUNDING.
>> COMPLETE.
>> MY UNDERSTANDING IF WE GO
WITH A NOSI, WE'RE IN A BETTER
POSITION TO BE ABLE TO SPEAK TO
WHETHER OR NOT APPLICATIONS ARE
WITHIN OUR MISSION AREA.
IT STRENGTHENS OUR POSITION IN
THAT NEGOTIATION.
>> ABSOLUTELY.
YES.
>> THANK YOU SO MUCH.
JEN.
>> THANK YOU FOR THE
PRESENTATION AND DISCUSSION.
SO IT SEEMS LIKE THE R21 PARENT
PROGRAM IS FAILING IF HALF THE
I.C.s AREN'T INVOLVED WITH IT
AND I WONDER IF THAT'S A
DISCUSSION OVERALL NIH IS HAVING
HOW TO REVITALIZE THAT AND IF
OTHER INSTITUTES HAVE THEIR OWN
R01 MECHANISMS IF THERE'S
SOMETHING TO LEARN FOR HOW TO
IMPROVE THE PARENT MECHANISM.
WHAT DOES THE FUTURE LOOK LIKE?
IF SOMEONE SUBMITS IT WOULD GO
DIRECTLY TO NIAMS AND HOW DO WE
PREVENT MISSION CREEP THANE WAY.
IF A P.I. ISN'T FAMILIAR WITH
THE NIAMS MAYBE THEY WOULDN'T
PICK THE NOSI.
BUT HOW DOES THIS PREVENT THE
MISSION CREEP IF NIAMS HAS THEIR
OWN MECHANISM AND WHAT CAN WE DO
WITH THE R21 MECHANISM IF WE
HAVE OUR OWN.
PERHAPS ADDITIONAL FUNDING AS
WELL.
IS THAT ON THE TABLE?
>> SO THE NOSI, IF WE DO OUR OWN
NOSI AND REFER TO THE R21 FOA
WE'RE BASICALLY USING THE PARENT
R21 FOA CRITERION.
HAVING A NOSI THAT GIVES US
BETTER CONTROL OF SAYING WE'LL
ACCEPT THIS BUT WILL NOT ACCEPT
THAT.
SO WE HAVE BETTER CONTROL IN
WHAT WE DO ACCEPT AND NOT.
THAT'S THE ADVANTAGE OF NOSI AND
YOU WERE ASKING ABOUT RO1s.
AND DID THAT ANSWER YOUR
QUESTION?
>> I GUESS I KNOW SOME HAVE
THREE R21s.
IS THAT A BETTER OPTION?
IT GIVES MORE MONEY PERHAPS AND
ALLOWS THE PROJECT TO BECOME
MORE MATURE.
DOES THAT WORK AND IS THAT
SOMETHING THAT NIAMS WOULD
CONSIDER GOING TO THEIR OWN
MECHANISM?
>> I'LL LEAVE THE ANSWER TO THAT
QUESTION THE MOST IS TO ISSUE
AND LOOK AT OTHER MECHANISMS WE
CAN DO.
THE R21 ALLOWS IF WE LOOK AT OUR
CLINICAL TRIAL FOA IT'S A
THREE-YEAR COST R21 MECHANISM.
SO THERE CAN BE VARIATIONS FOR
THE R21 FOA BUT THAT TOPIC IS
BICKER THAN WHAT WE DISCUSSED
A
AND.
>> THANK YOU FOR THE QUESTION
AND WE'RE TRYING TO UNDERSTAND
HOW THE NEEDS AND OPPORTUNITIES
ARE EVOLVING AND ALWAYS LOOKING
TO OTHER INSTITUTES AND CENTERS
TO LEARN FROM THEIR EXPERIENCES.
WHAT ARE THE BEST PRACTICES.
AND WE'RE MORE INTERESTED IN
THINKING ABOUT HOW TO HELP
INNOVATION AND RESEARCH.
THIS SPEAKS TO THAT AND
SOMETHING THAT WILL BE AN
ONGOING TOPIC OF DISCUSSION AS
WE CONSIDER TEAM SCIENCE AND THE
R21 AND OTHER EFFORTS THAT HOUSE
A MAJOR GOAL SUPPORTING
INNOVATION.
I MOPE THE R21 WORKING GROUP
WILL CONTINUE TO EXIST AND
CONTINUE TO THINK ABOUT THESE IN
OTHER ISSUES MOVING FORWARD.
DOES ANYBODY ELSE WANT TO CHIME
IN AND FEEL FREE BEFORE I GO TO
STEWART TO MAKE COMMENTS ON THIS
SPECIFIC POINT.
>> NOTHING HERE, THANKS.
>> FAYE COVERED IT NICELY AND
HIT THE HIGH POINTS.
>> GREAT.
THANK YOU SO MUCH.
>> THAT WAS AN EXCELLENT REPORT
AND I PERSONALLY LEARNED A LOT.
THANK YOU.
I THINK WE NEED TO REVISIT THE
ASPECTS TO.
ONE OF THE OTHER MEMBERS OF
COUNCIL RAISED THAT AS SALARIES
AND EXPENSES HAVE GONE UP 3% OR
MORE PER YEAR, THE PAYOUT FOR
THIS PARTICULAR PROGRAM HAS
REMAINED STATIC.
WHERE ENGINEERS MAY HAVE
SALARIES PAID FOR AND THIS IS
THE MODEL IN EUROPE TOO TO PAY
FOR PERSONNEL AND APPLY FOR
GRANTS TO PAY FOR SUPPLIES, THAT
CERTAINLY ISN'T THE CASE IN THIS
COUNTRY.
THE TOTAL AMOUNT OF 275 OVER TWO
YEARS IS REALLY QUITE PALTRY
WHEN YOU LOOK AT IT.
DOING SCIENCE IS EXPENSIVE AND
IT'S GROWN MORE EXPENSIVE OVER
THE LAST 15 YEARS.
WE NEED TO LOOK AT THAT TO STAY
COMPETITIVE.
>> THANK YOU FOR HIGHLIGHTING
THAT POINT.
I DIDN'T REALIZE THE R21 BUDGET
AMOUNT HADN'T CHANGED FOR SO
LONG.
CLEARLY GIVEN THAT SHOWS YOU
EVOLVING ROLE OF THE R21 OVER
TIME.
DID YOU WANT TO MAKE COMMENTS AT
THIS POINT?
>> THANK YOU, DR. CRISWELL.
I TYPED MY COMMENT INTO CHAT.
I WANTED TO THE QUESTION ABOUT
REVIEW AND WHAT WILL HAPPEN IF
WE WITHDRAW FROM THE PARENTS AND
ISSUE A NOSI AND THE ANSWER IS
NOTHING.
THE REVIEW WILL REMAIN THE SAME
IN THE STUDY SECTION
ANNOUNCEMENT ASSIGNMENTS WILL
REMAIN THE SAME.
>> THANK YOU FOR CIRCLE BACK TO
THAT POINT.
BOB, PLEASE, GO AHEAD.
>> THE ONE THAT COMES AROUND
REGULARLY, I HAVEN'T HEARD
ANYBODY REALLY TALK ABOUT
CHANGING THE R21 CAP.
THE QUESTION ON MODULAR RO1s
COMES UP EVERY SIX MONTHS.
AS SOON AS YOU RAISE THAT
EVERYBODY WILL GO FOR THE HIGHER
AMOUNT.
THE NUMBER OF MODULAR RO1 AWARDS
IS DECREASING AND CORRELATES IN
THE SAME THE AVERAGE COST OF AN
RO1 IS INCREASING.
THESE ARE SUBJECTS THAT ARE
EVERGREEN AND ONCE YOU CHANGE
THINGS YOU'LL CHEW UP MORE OF
THE PATH.
IT'S AN IMPORTANT QUESTION FOR
COUNCIL GIVEN THE SIZE OF THE
PIE, IS IT BETTER TO GIVE MORE
SUPPORT TO FEWER PEOPLE OR
BETTER TO SPREAD THE WEALTH?
IN THE PAST, COUNCIL'S ALWAYS
BEEN CLEAR FOR EXAMPLE THE
INITIAL DOWNWARD NEGOTIATION AND
SOME I.C.s DO NOT IS IMPORTANT
TO GET MORE AWARDS TO MORE
PEOPLE.
IT'S IMPORTANT AS WE FIGURE OUT
HOW TO PAY FOR THIS ENTERPRISE.
>> I'M LEARNING INSTITUTES VARY
IN EVERY RESPECT IN WHICH THEY
CAN VARY AND AS AN EXAMPLE,
NIGMS IS DEEPLY COMMITTED TO
SPREADING THE WEALTH.
IT WORKS HARD TO FUND MORE
INVESTIGATORS AT LOWER LEVELS.
IT'S A TRADE-OFF AND AN
IMPORTANT TOPIC.
THANK YOU FOR HIGHLIGHTING THAT
TODAY.
JEN, BACK TO YOU.
>> TO ADDRESS BOB'S QUESTION.
ONE OF THE THINGS THAT'S NICE
ABOUT THE MODULAR BUDGET IT'S
EASIER AND LESS ADMINISTRATIVE
BURDEN TO PUT IT TOGETHER IT
WILL BE INTERESTING TO HAVE AN
ANALYSIS HOW MANY COME IN AT THE
275 AND 300 AND SEE IF WE CAN
REDUCE THE BURDEN ON APPLICANTS
AT LEAST SOME KNOWING SOMETIMES
I PUT A GRANT IN IN THE
PERSONNEL COST ARE 250.
COULD WE REDUCE THE
ADMINISTRATIVE BURDEN OF
SUBMITTING THEM.
>> I AGREE THERE'S A DOWNWARD
SLOPE IN THE AWARDS THAT ARE
MODULAR.
AT SOME POINT IT'S RIDICULOUS.
WHEN IT'S DOWN TO 10% THEN WHAT
ARE WE DOING.
>> LUIS.
>> THE TWO-YEAR CYCLE CREATES
EXTRA BURDEN FOR APPLICATIONS.
IF IT TAKES TWO TRIES, THAT CAN
TAKE A WHOLE YEAR OF APPLYING
FOR A TWO-YEAR GRANT.
ALSO THE NIH IS CONSTANTLY
CONCERNED OUR PROGRESS IS
INCREMENTAL BUT I THINK YOU'RE
ALMOST BY DEFINITION DOING
INCREMENTAL RESEARCH.
I TEND NOT TO BE A BIG BELIEVER
IN R21s MYSELF.
>> THAT'S PART OF WHY SOME
INSTITUTES NO LONGER SUPPORT
THEM AT ALL.
WHEN YOU LOOK AT THE ANALYSIS
THAT FAYE AND THE TEAM SUGGESTED
THERE'S A SUGGESTION THAT MAYBE
THERE'S AN EFFECTIVE WAY OF
SUPPORTING RESEARCH.
YOU LOOK AT THE PUBLICATIONS AND
THE IMPACT OF THE PUBLICATIONS.
NOWADAYS IT'S DIFFICULT TO THINK
OF ANY INVESTIGATOR HAVING AN
R21 AS A SOLE SUPPORT.
NEVERTHELESS SOME SETTINGE EEER
SOME INVESTIGATORS CAN USE THE
MECHANISM MORE EFFECTIVELY.
THERE'S DILEMMA FOR US IN TERMS
OF EVALUATING IMPACT.
MANY YEARS AGO THE NIH HAD THE
R29s FOR NEW INVESTIGATORS.
IT WAS A SMALL RO1 AND ABANDONED
AS AN APPROACH FOR NEW
INVESTIGATORS BECAUSE IT WAS
UNDER FUNDING THE RESEARCH
EFFORT AND THEREFORE CONSIDERED
NOT AN EFFECTIVE WAY IF WE
WANTED TO SUPPORT NEW
INVESTIGATORS WE SHOULD GIVE
THEM THE FULL AMOUNT OF REGULAR
RO1.
THIS DISCUSSION REMINDED ME OF
THAT DISCUSSION.
ABOUT THE LEVEL OF FUNDING AND
WHAT'S INTENDED IN THE
MECHANISMS AND UNDER FUNDING IS
A PROBLEM WITH SOME OF THESE
UNDOUBTEDLY.
>> THANK YOU FOR POINTING TO THE
ANALYSIS ON THE PRODUCTIVITY ON
SHARING THE PUBLICATION AND THE
R21 BEING ON AVERAGE BETTER THAN
RO1s.
I WANTED TO SAY THAT.
>> I WOULD BET ALL THAT IS
BECAUSE THE DENOMINATOR IS LOWER
BECAUSE THERE'S FEWER AMOUNTS --
THERE'S LESS INVESTIGATED.
WE WANT TO PUT EVERYTHING WE DO
AS PART OF A GRANT AND WE ALL
WANT TO SEE THAT.
>> THE USE OF R21 IS INCREASING
OR FOR YOU COMMUNITY.
MORE PEOPLE ARE APPLYING FOR IT.
IF WE VIEW THE NIH MECHANISM AS
A SORT OF A PRODUCT THAT MEANS
THERE'S MORE CONSUMERS THE
RESEARCH COMMUNITY ARE USING
THAT PRODUCT.
NO MATTER HOW EFFECTIVE IT IS
MORE PEOPLE ARE USING IT AND
HAVE TO CONSIDER HOW USEFUL THIS
IS TO THE COMMUNITY AT LARGE FOR
A PARTICULAR SECTOR THIS MAY NOT
BE AS USEFUL.
THERE'S PROJECTS AT THE INITIAL
STAGE EVEN TO THE THERE'S AN
EMPHASIS ON INNOVATION.
>> THE RESEARCH COMMUNITY WE'RE
TRYING TO SUPPORT IS VERY
DIVERSE IN TERMS OF THEIR NEEDS.
>> IT SOUNDS LIKE IT'S A USEFUL
BRIDGE AND I'D ADD THAT EVEN IF
WE SHOW DATA THAT SUGGESTS IT
STILL HAS UTILITY AND VALUE
DOESN'T MEAN CAN'T IMPROVE IT.
ANY ADDITIONAL INVESTMENT IN THE
R21 WILL COME FROM ANOTHER AREA.
WE HAVE TO THINK HOLISTICALLY.
TONY, DID YOU WANT TO MAKE
ADDITIONAL POINTS?
>> I WANTED TO ACKNOWLEDGE A
POINT THAT SOMETIMES WAIT BEINGO
YEARS TO GET AN ANSWER ON A
PROJECT IS UNFORTUNATE.
I HOPE WE CAN DO SOMETHING TO
SPEED IT UP.
ONE OF THE THINGS THE GROUP
CONSIDERED WHEN WE WERE
ANALYZING THE R21 AND ITS PLACE
IN THE PANTHEON OF MECHANISMS IS
IT'S NOT JUST A GOOD MECHANISM
FOR SOME INVESTIGATORS TO
RECEIVE CONTINUOUS SUPPORT BUT
THE PRIMARY MECHANISM FOR
DIFFERENT SMALL GRANTS MECHANISM
AND SOMETHING RO1 ISN'T IDEALLY
SUITED FOR AND THOUGHT IT PLAYED
A ROLE TO GENERATE A NEW RISK OR
NEW MODEL OR OTHER APPLICATIONS
SUITABLE FOR THAT PARTICULAR
MECHANISM.
THAT COULD EVOLVE OVER TIME.
>> LET ME CHECK IN ON OUR
TIMING.
WE STILL HAVE PLENTY OF TIME SET
ASIDE FOR DISCUSSION OF THE
PRESENTED TOPICS OR NEW TOPICS
THE TENTATIVE PLAN WAS TO BEGIN
A BREAK AT 11:55 EASTERN.
AT THIS POINT WE CAN TAKE MORE
COMMENTS ABOUT THE R21 OR OTHER
PRESENTED TOPICS OR NEW TOPICS.
I KNOW VALENTINA HAD ONE SHE
WANTED TO SHARE AT SOME POINT.
>> HOW WILL THE TOPICS ARPA-H
WILL FOCUS ON WILL BE CHOSEN AND
IF NIAMS CAN ADVOCATE FOR
DISEASES COVERED UNDER YOUR
MISSION AREA?
>> YEAH.
SO THE DEVELOPMENT OF ARPA-H IS
STILL IN PROCESS AND PROGRESS
FOR SURE.
WE DON'T HAVE A DIRECTOR BUT THE
GOAL IS FOR THE RESEARCH AND
NATURE OF THE RESEARCH AND
QUESTIONS AND THE GOALS TO BE
COMPLIMENTARY WITH INTERACTION
COLLABORATION ACROSS THOSE
AGENCIES.
OUR UNDERSTANDING IS ARPA-H WILL
BE SEEKING IDEAS FROM THE
PROJECTS NOT ONLY FROM THE
PROGRAM MANGERS WHICH ARE GOING
TO BE CRUCIAL ROLES AND
EXPERIENCED MANGERS BUT FROM THE
BROADER COMMUNITY.
THIS WAS REFLECTED IN THE
LISTENING SESSIONS THE NIH
DIRECTOR CONVENED AND MANY
PLAYED AN ACTIVE ROLE IN
ADVOCATING FOR SOME PROJECTS
WITHIN OUR MISSION AREAS AND
DARPA LIKE PRESUMABLY
APPROPRIATE FOR ARPA-H.
AND MY UNDERSTANDING IS IT'S
LIKELY NOT TO BE SOMETHING
PURSUED UP FRONT TO HELP ARPA-H
ESTABLISH A UNIQUE I'D DID I BUT
PRESUMABLY PROGRAM OFFICERS AT
NIH WOULD BE HIGHLY QUALIFIED TO
SERVE IN THE ROLE AND WOULD HELP
WITH THE BACK AND FORTH.
THERE'S ALSO TENTATIVE PLANS FOR
IDEAS BEING DEVELOPED WITHIN
ARPA-H TO BE PRESENTED TO NIH
LEADERSHIP TO IDENTIFY AREAS OF
COLLABORATION AND SYNERGY.
I DON'T KNOW WHAT ALL THE
MECHANISMS WILL BE TO SEEK IDEAS
BUT WE'LL LOOB FOR OPPORTUNITIES
TO DO THAT AND HOPE OUR
COMMUNITY INCLUDING ALL OF YOU
WILL HELP ADVOCATE.
I THOUGHT YOU HAD YOUR HAND UP
FOR A COMMENT.
I WELCOME ANY OTHER COMMENTS.
I MAY HAVE MISUNDERSTAND THAT.
ADAM RUSSELL JUST ANNOUNCED AS
THE ACTING DEPUTY DIRECTOR OF
ARPA-H HAS HIGHLY APPROPRIATE
EXPERIENCE AND WE'RE EXCITED TO
SEE HIM IN THAT ROLE.
WE'LL BE KEEPING YOU ABREAST OF
OTHER DEVELOPMENTS.
OATH QUESTIONS PEOPLE WOULD LIKE
TO RAISE, TOPICS TO CIRCLE BACK
TO OR --
>> THANK YOU FOR THE ROUNDTABLE.
ONE THING THAT CAME TO MIND IS
WITH THE HEAL IT SEEMS LIKE A
UNIQUE OPPORTUNITY TO INCREASE
THE PROMINENCE OF NEUROBIOLOGY
IN OUR FIELD, BONE, MUSCLE, SKIN
AND THE ROLE OF THE NERVOUS
SYSTEM.
THIS IS A TOPIC OF DISCUSSION TO
RAISE BECAUSE I'M NOT AN EXPERT
IN THIS AREA BUT IF ANYBODY FROM
THE NIAMS STAFF HAS THOUGHTS ON
WAYS OF BETTER USING THIS AS AN
OPPORTUNITY TO INTEGRATE
NEUROBIOLOGY IN OUR SPECIFIC
FIELDS.
>> THANK YOU FOR RAISING THAT
AND I'M SURE BOB THOUGHT ABOUT
THIS.
FIRST WE'RE COLONEL DOING
EVERYTHING WE CAN TO LEVERAGE
HEAL RESOURCES.
IF YOU RECALL FROM SLIDES I
SHOWED THERE'S A SUBSTANTIAL
AMOUNT OF MONEY GOING TO HEAL.
SUCH A SIGNIFICANT AMOUNT THAT
REQUIRES INNOVATIVE THINKING
ABOUT PAYING MECHANISMS AND
APPROACHES.
EVERYTHING RELATED TO OPIOID USE
AND ABUSE, ETCETERA.
THE PORTFOLIO CONTINUES TO
EXPAND.
WE HAVE HAD BACK PACKS AND WE'RE
EXCITED THAT BACK PAIN IS HAS
BEEN WELL ESTABLISHED AND WE'RE
EXCITED ABOUT THE PROGRAM.
AND WE HAVE ANOTHER EFFORT THAT
NIAMS WILL LEAD IN COLLABORATION
WITH SEVERAL OTHER I.C.s THAT
FOCUS ON MECHANISMS IN THE JOINT
AND THE NEURAL PATHWAYS NEW
AREAS WE'RE INTERESTED IN
UNDERSTANDING BETTER.
THERE'S FUNDING OPPORTUNITIES OR
INTERESTS IN HEAL THAT SPEAK TO
OR RECOGNIZE SOME OF THE AREAS
OF MEDICINE THAT CAN FALL
WILLING HEAL THAT WE KNOW
RELATIVELY LITTLE ABOUT.
WE'RE HOPING IN ADDITION TO THE
HEAL FUNDS WE CAN CONTINUE TO
LEVERAGE WE'LL HAVE FUNDS THAT
WILL COME DIRECTLY TO NIAMS FOR
PAIN-RELATED RESEARCH.
LET ME ALLOW OTHERS MORE
INVOLVED OR HAVE COMMENTS TO
MAKE TO SPEAK UP STARTING WITH
BOB.
WE ARE LOOKING AT THE
INNERVATIONS THAT MAKE UP THE
JOINT AND WE'LL HAVE FUNDING
DECISIONS.
THAT WILL BE TREMENDOUSLY
EXCITING IN THE WAY YOU
DESCRIBED.
AND THE GOOD NEWS IS THERE'S A
COLLABORATIVE EFFORT.
IMAGINE WE'RE TALKING TO NINDS
AND THAT WILL BEAR FRUIT.
THEY'RE INTERESTED.
LAND KAPLAN'S WORK ON THE
PROJECTION FROM TH17 BEING
CONTROLLED FROM AFFERENT NEURONS
FROM EFFERENT SIGNALS AND YOU
HAIRED THE INITIAL LECTURE AT
S.I.D. AND -- YOU HEARD AND THE
VAGUS NERVE CONSISTS OF A LOT OF
AFFERENT NERVES WITH TRIP V
CHANNELS ON THEM.
AND CHEMOKINES AND THEY CAN
REGULATE NERVES.
WE'RE WORKING ON A ROUNDTABLE
MEETING WORKSHOP.
WE HAVE THE QUESTION OF HOW DO
YOU INTEGRATE ACROSS THE
DIFFERENT DOMAINS.
AND THERE'S THE ISSUE OF HOW
NEURONS NOT JUST CONTROL PAIN
BUT HEALTH.
IT WAS LOOKING AT NOCICEPTIVE
NEURONS AND IT BECAME APPARENT
TO LOOK AT SYMPATHETIC TONE
COMING BACK DOWN.
GOING BEYOND THAT, YOU ALSO HAVE
THE DIFFERENT DOMAINS IN TERMS
OF DIFFERENT TYPES OF ANALYSES.
FOR SKIN AND JOINTS YOU DO
DIFFERENT OMICS.
THE GENETICS OF THE PERSON, THE
EPIGENETICS AND SPATIAL
RESOLUTION.
YOU HAVE ANOTHER DOMAIN THERE
DIFFERENT LEVEL OF INTEGRATION
IT BECOMES COMPLICATED IN NOT
JUST THE DE MAINS BUT CONTEXT.
INNOVATING ACROSS RESEARCH
DOMAINS IN THE TYPES OF
EXPERIMENTS AND INTEGRATING
ACROSS EXPERTISE AND NIGS
INSTITUTES.
THE BIG PICTURE IS ALL THE
ABOVE.
IN BACPAC IT TRIES TO CONTRIBUTE
TO A PERSON'S SENSATION OF PAIN.
YOU CAN IMAGINE THERE'S HUNDREDS
OF DIFFERENT THINGS INVOLVED.
HOW DO YOU GET TO BOTH
UNDERSTANDING THE MOLECULAR
PATHWAYS OF GENOMICS OF DISEASE
HOW IT INTEGRATES TO LEAD TO
WHAT THE CONDITION, PAIN, ITCH,
ETCETERA.
IT'S AN EXCITING AREA.
IT'S A CHALLENGE FOR NIH TO GET
THERE.
IT WILL TAKE A COMBINATION OF
INVESTIGATOR INITIATED AND TEAM
SCIENCE BUT I THINK IT'S A
GROWTH INDUSTRY WHERE COMMUNITY
INPUT IS VALUABLE.
>> THANK YOU, JOB.
SUSAN.
>> I WANTED TO BRING BACK THE
ISSUE RAISED DURING YOUR REPORT
THE INSTITUTE IS MOVING FORWARD
WITH A NEW STRATEGIC PLAN AND
THE NOVEL APPROACH TO RESEARCH
AND UNDERSTANDING DISEASES AND
THE BIOLOGY OF THE DISEASES AND
ADMISSION AND ADVANCE THE
CROSS-CUT THEMES.
THERE'LL BE AN OPPORTUNITY IN
THE NEAR FUTURE TO RAISE THOSE
AND TO BRING THOSE TO OUR
ATTENTION.
OUR PREVIOUS PLAN WAS TO DO MORE
IN THE NEXT PHASE.
>> MARK OR SOMEONE --
>> THAT'S STRANGE.
>> THERE'S SOMETHING HAPPENING
WHEN YOU JOINED, SAID.
WE'RE HEARING A BACKGROUND.
>> MAYBE HE'S ON THE VIDEOCAST?
DO YOU HAVE BOTH GOING?
>> IF YOU'RE HAVING TROUBLE YOU
SHOULD JOIN VIA THE LINK NOT THE
VIDEOCAST.
REACH OUT TO ONE OF US.
>> I WANT TO ACKNOWLEDGE TO
INTEGRATE THE PATIENT IN THE MIX
I WAS TALKING ABOUT.
THANKS I'LL PAUSE AND ASK
WHETHER ANYBODY ELSE WOULD LIKE
TO RAISE A QUESTION ABOUT THE
ISSUES TOUCHED UPON SO FAR THIS
MORNING OR NEW TOPICS TO RAISE
INITIAL DISCUSSION WITH THE
FELLOW COUNCIL MEMBERS.
>> SOMETHING WE MENTIONED LAST
MEETING AND NOW CAN WE THINK
ABOUT ALL CONTRIBUTIONS THAT
MAKE IT INTO THE POSSIBILITY OF
BECOMING TENTATIVE DISCOVERY AND
NIH GRANTS FOR THE RO1.
CURRENTLY THE WAY WE EVALUATE
PRODUCTIVITY IN MY OPINION IS
NARROW.
WE USE METRICS INTO THE PAPERS
THAT HAVE BEEN PUBLISHED.
THERE'S THEY GO INTO THE ABILITY
OF DISCOVERIES.
THERE'S INVISIBLE LABOR THAT
HASN'T BEEN AWARDED NOR
COMPENSATED.
WHEN I LOOK AT MY OWN
EXPERIENCES AS WELL AS THOSE
THAT ARE MEMBERSHIP AND WHERE
STUDIES EXCLUDED THEY CREATE
INITIATIVES ALIGNED WITH NIH TO
CREATE MORE INCLUSIVITY AND THEY
DON'T GET EVALUATED AS
PRODUCTIVITY CREATING A MORE
DISADVANTAGE TO PEOPLE WHEN
THEY'RE EVALUATED THROUGH THE
SAME LENS.
THE IDEA CAN WE CREATE SOME
GROUPS THAT ARE TASKED TO THINK
ABOUT HOW WE MAKE EFFORTS FROM
MY COLLEAGUE CREATING THIS TO
HAVE MANY MORE STUDENTS
ESPECIALLY BE REWARDED AND
CONSIDERED EQUIVALENT WHEN WE
JUDGE ON THE RO1 AND MAKE THE
MENTORING WE KNOW AND
DISPROPORTIONATELY BURDEN PEOPLE
OF COLOR AND THE RISK IS WE
HAVEN'T INTERPRETED SCIENTIFIC
DISCOVERY YET LOOK EIGHT
COLLECTIVE KEPT TOGETHER BY FEW
AND KEEP THROWING OUT THE SYSTEM
AND CONTINUOUSLY ABUSING OF
THEM.
>> THANK YOU FOR THE BIG PICTURE
TOPIC AND FOLLOWS FROM AN ISSUE
YOU RAISED LAST TIME FOR CREDIT
FOR MENTORING AND THOSE FROM
UNDER REPRESENTED BACKGROUNDS
AND REMINDS ME ALSO OF WHAT I
THINK HAS BEEN SOME PROGRESS AT
MANY INSTITUTIONS IN RECOGNIZING
CONTRIBUTIONS TO COLLABORATIVE
RESEARCH.
AND WHAT SUBSTANTIVE
CONTRIBUTIONS HAVE YOU MADE EVEN
IF NOT FIRST OR SENIOR
AUTHORIZE.
IN TERMS OF LESSONS LEARNED TO
LOOK BACK AT THAT EXPERIENCE AND
TRY TO SEE WHAT THAT TOOK TO
MAKE SOME PROGRESS IN THAT AREA.
I WOULD LOVE OTHER THOUGHTS.
>> I WANT TO APPLAUD VALENTINA
FOR THE THOUGHT AND LIKE SHE SET
IT OUT IT'S ETHICALLY NECESSARY
AND IMPORTANT AND PRACTICALLY
IT'S ALSO REALLY GOOD AND
SCIENTIFICALLY IT'S IMPORTANT.
I'VE SEEN THEY GRAVITATE TOWARDS
ISSUES VERY UNDER STUDIED.
THERE'S A BRILLIANT WOMAN IN MY
DEPARTMENT WHO IS STUDYING
MECHANISMS OFFAL -- OF
ALOPECIA AND HAS CONTINUED TO
MAKE INSIGHTS.
HAVING THIS EFFORT TOWARDS
REWARDING PEOPLE TO MOVE TOWARDS
EFFORTS ON DI QUESTIONS IS NOT
JUST ETHICALLY IMPORTANT BUT
PRACTICALLY VERY IMPORTANT FOR
WHAT WE DO IN THE SCIENTIFIC
PROGRESS WE MAKE IN DISEASES.
>> NEEDLESS TO SAY LIKE THE
OTHER DAI ISSUES REQUIRES BROAD
COMMITMENT TO CHANGE AND ACTION
ON THE PART OF THE NIH AND
INSTITUTIONS AND THE FORWARD
SCIENTIFIC COMMUNITY WHICH MAKES
IT CHALLENGES BUT DOESN'T MEAN
WE SHOULDN'T BE TRYING TO DO
SOMETHING IN THIS AREA.
HAS A NOTE IN THE CHAT.
I'LL READ THIS.
SOUNDS LIKE SUE CAN'T GET ACCESS
TO AUDIO.
SHE SAID THE ISSUE VALENTINA
RAISES IS ANALOGOUS OF TRYING TO
EMBED PATIENT ENGAGEMENT ACROSS
THE SCIENTIFIC ENTERPRISE
BECAUSE THERE AREN'T NECESSARY
RESUME AFFIRMING RESULTS FROM
PATIENT ENGAGEMENT AND DOING IT
WELL.
I COMPLETELY AGREE AND HOPEFULLY
THAT'S SOMETHING WE CAN
COLLECTIVELY THINK MORE
CAREFULLY ABOUT AND ADAPTING TO
MORE FULLY BUT RECOGNIZE THE
CONTRIBUTIONS.
JOAN.
>> THIS MAY IN TANGENTIAL BUT
WE'VE BEEN OBSERVING HERE
THERE'S ALWAYS BEEN A CHALLENGE
TO ENROLL MINORITIES IN LUPUS
TRIALS BUT OUR GROUP AT COLUMBIA
ARE FINDING THEY HAVE MORE
RESISTANCE TO CLINICAL TRIAL
PARTICIPATION EVEN TOTALLY
BENIGN THINGS AND SHE HAS A
GRANT TO EDUCATE PATIENTS WITH
LUPUS ABOUT LUPUS CLINICAL
TRIALS AND SHE'S GET SO MUCH
RESISTANCE TO EVEN JOINING THOSE
TRIALS TO LEARN ABOUT TRIALS.
IT'S NOT EVEN A TRIAL.
IT'S JUST AN EDUCATIONAL THING.
MY POINT BEING THAT I'M
REALIZING HOW MUCH COVID WITH
ALL THE MISINFORMATION HAS SET
US BACK ON THE MINORITY TRAINING
FOR GETTING PATIENTS INTO
STUDIES?
I THINK THAT PROBABLY HAS FUELED
A LOT OF THIS RESISTANCE AND I
DON'T KNOW IF IT'S A COMMON
PROBLEM OR JUST IN OUR AREA.
I'LL THROW THAT OUT.
>> VALENTINA.
>> RESONATES WITH ME TWO
COLLEAGUES WE'RE LOOKING AT THE
DAMAGE DONE AND THE QUESTION IS
AND IN A WAY OUR GOALS IS ONE
AND WE CREATE THE SYSTEM WHERE
PEOPLE WOULD CONTINUE TO DRAIN
FROM OUR SYSTEM BECAUSE THEY'RE
DOING WHAT WE ASKED THEM TO DO
BUT THEN THE NATURE OF
OCCURRENCE AND LIFE LINE AND THE
RO1 AND RESEARCH IS THE ONE
THEY'RE JUDGED BY.
IT'S A HEART-BREAKING SCENARIO
AND I'M SPEAKING FROM A
PHYSICIAN OF PRIVILEGE.
>> YOU'RE SPEAKING TO THE
WHOLISTIC ASSESSMENT FOR WITH
WHAT WE HAVE CURRENTLY.
SUE.
>> I'M GOING TO TRY.
I WANTED TO FOLLOW-UP ON JOAN
AND VAL ENTINA.
WE'RE SEEING THIS POST COVID-19
AND NOT SURE OF THE ROOT OF THE
EXACERBATION BUT MOST OF THE
ANSWER STILL LIES IN MAKING SURE
PATIENTS AND COMMUNITIES SEE
THEMSELVES REFLECT ED AND WHO
LIVES WHERE I LIVE AND PRAYS
WHERE I PRAY NEEDS TO BE IN THE
DESIGNING AND MESSAGING SO IT
FEELS THERE'S A SAMENESS.
THIS PERSON ISN'TI IING -- IS
COMING FROM THE OUTSIDE BUT IT'S
A PARTNERSHIP AND AN EXTENSION
OF WORKING TOGETHER I DON'T HAVE
THE ANSWERS FOR MAKING THAT
HAPPEN BUT IN ALL THE WORK I'M
DOING INITIALLY IN THE EARLY DAY
P CORI WAS NICE TO HAVE AND
WE'RE SEEING IT'S ACTUALLY
ESSENTIAL YOU DON'T GET FAR
WITHOUT IT.
>> I'M LOOKING AT LUIS' COMMENTS
ABOUT PRACTICAL STEP AND WHEN
THE TOPIC WAS FIRST RAISED BY
VALENTINA AND GIVEN THE
IMPORTANCE OF THE TOPIC AND THE
FACT IT'S A BIG BROAD ISSUE I
WAS WONDERING WHETHER WE CAN
ORGANIZE A SESSION AT OUR NEXT
COUNCIL MEETING IN THE SAME WAY
YOU'LL SEE WE'LL BE HIGHLIGHT
ING DATA SHARING ISSUES AND IT'S
NOT CLEAR WHAT OFFICE AT THE NIH
FOR EXAMPLE IS BEST POSITIONED
TO BE THINK , WHAT SHOULD BE
BEYOND BIO SKETCHES AND HOW CAN
WE LEVERAGE THE RESPECT AND
REPUTATION OF THE NIH AND THE
IMPORTANCE OF THE NIH IN
SPEAKING TO THIS ISSUE?
IT'S A QUESTION IN PART BECAUSE
I'M SO NEW TO THE NIH BUT THAT'S
NOT OBVIOUS.
THOSE WHO HAVE BEEN AT THE NIH
LONGER THAN I HAVE, SUSAN AND
BOB AND GAIL MAY HAVE INITIAL
THOUGHTS.
IT'S SOMETHING WE HAVEN'T
DISCUSSED INTERNALLY YET BUT IF
THIS SAY TOPIC WE CAN TRY TO
PLAN FOR SUBSEQUENT DISCUSSION
AT A FUTURE MEETING.
>> SOME INSTITUTES AND INITIALS
AROUND NIH IN PARTICULAR THE
BRAIN INSTITUTE.
AND RELATED TO COMMUNITY
ENGAGEMENT AND THERE'S EFFORTS
ON MATERNAL MORTALITY AND
RESEARCH.
AND THERE'S APPROACH TO DEAL
WITH CHALLENGES AND RECOGNIZED
INVESTIGAT
INVESTIGATORS AND I THINK WE
HAVE SEEN AN EVOLUTION OF THE
FIELD AND HOW WE THINK ABOUT
RESEARCH AND THE RELATED VALUE
OF INDEPENDENT RESEARCH VERSUS
TEAM SCIENCE.
AND HOW WE RECONCILE THAT WHEN
IT COMES TO TENURE AND FUTURE
GRANTS AND WE ACKNOWLEDGE THE
PARTICIPATION IN TEAM SCIENCE
AND APPLICATIONS, ETCETERA.
IT'S BEEN THOUGHT ABOUT BY
PEOPLE INVOLVING THE SCIENCE OF
TEAM SCIENCE AND ADMINISTRATION.
I THINK IT WOULD BE A GREAT
OPPORTUNITY THE INSTITUTIONS DO
HAVE A RESPONSIBILITY HERE AS
WELL WHEN IT COMES TO TENURE AND
SO ON.
WE HAVE A LOT TO LEARN FROM THEM
AS WELL.
>> I WOULD ALSO THANK YOU SO
MUCH AND IF I'M RECALLING
CORRECTLY, EVEN RECENT METRICS
ABOUT PRODUCTIVITY FOR TEAM
SCIENCE VERSUS RESEARCH PROJECTS
ATTEST TO THEIR TREMENDOUS
IMPACT.
WE HAVE DATA NOW THAT CAN
SUPPORT THE IMPORTANCE OF TEAM
SCIENCE AND OBVIOUSLY THEN
SPEAKS TO THE IMPORTANCE OF
CONTRIBUTING AS PART OF A TEAM
NOT SIMPLY AS AN INDIVIDUAL
INVESTIGATOR.
BOB.
>> I THINK THE IDEA OF CIRCLING
BACK TO THE QUESTION OF CREDIT,
IF YOU WILL, OR RECOGNITION OF
ACCOMPLISHMENTS VERSUS THE P.I.
OR SENIOR AUTHOR IS CRITICAL FOR
THE FUTURE.
AND I HATE TO SAY THIS BUT I
THINK IT WOULD BE OAR THAT WOULD
CONTROL THE BIO SKETCH PART OF
IT.
I DO THINK THERE WAS AN ATTEMPT
TO DO THAT IN THE STATEMENT OF
ACCOMPLISHMENTS THAT SOME OF
THAT WAS SO YOU DIDN'T JUST PUT
A LOT OF GARBAGE IN YOUR BIO
SKETCH.
YOU HAD TO POINT TO
ACCOMPLISHMENTS.
THE OTHER PART WOULD BE TO SAY
YOU PLAYED A CRITICAL ROLE IN
THE PRODUCTION OF SOME DATA SET.
I ALSO DO WONDER GOING BACK TO
SUSANA'S COMMENTS ABOUT THE ROLE
OF THE INSTITUTIONS.
I GUESS IT DOES STILL BOTHER ME
WHEN A STUDY SECTION SAYS THIS
PERSON MAY NOT BE INDEPENDENT.
THAT'S TO MY THINKING SORT OF
RIDICULOUS.
IT'S NOT ABOUT BEING
INDEPENDENT.
IT'S CAN YOU PRODUCE WHAT YOU
SAID YOU'RE GOING TO DO AND IS
IT WORTH DOING.
AND IF IT'S IMPORTANT WORK, WHO
CARES WHETHER YOU'RE
INDEPENDENT.
IN SOME WAYS THAT TRACKS BACK TO
THE TENURED DECISION ALWAYS HAS
BEEN ESSENTIAL YOU DEMONSTRATE
INDEPENDENCE.
WHEN YOU GET TO A BIG DATA SET,
INDEPENDENCE GETS TO BE
PROBLEMATIC.
YOU CAN'T DO IT ALL BY YOURSELF.
YOU CAN DO IT WITH A MENTOR BUT
YOU HAVE TO POINT TO A CRITICAL
CONTRIBUTION THAT YOU PLAYED
SAME WOULD HOLD FOR PATIENT
ENGAGEMENT AND INCLUSION.
THE QUESTION IS HOW IS THIS
PLAYING OUT BACK IN THE HOME
INSTITUTIONS?
THERE WERE EFFORTS AND MOVING
AND OUTSTANDING CONTRIBUTIONS TO
LARGE PROJECTS.
AND NIH HELP WITH THAT IN THE
SAME WAY NIH IS TRYING TO HELP
WITH HARASSMENT?
IS THERE A WAY TO ENGAGE NIH.
NIH IS NOT MAKING TENURED
DECISIONS BUT CAN WE FOSTER THE
SENSE OF RECOGNITION OF THESE
TYPES OF CONTRIBUTIONS.
I DO LIKE THE IDEA OF FOCUSSING
ON THIS IN FUTURE COUNCIL
MEETINGS.
>> SAID.
>> SORRY.
I'VE HAD TECHNICAL ISSUES TODAY
BUT FINALLY MANAGED TO GET UPON
-- ON.
THIS IS A TIMELY ISSUE.
I'M NOT REALLY CONVINCED THAT
TINKERING WITH THE BIO SKETCH
WILL ADDRESS THE ISSUE, TO BE
HONEST WITH YOU.
I SERVED ON THE CLINICAL TRIALS
STUDY SECTION FOR FIVE YEARS AND
I CAN TELL YOU THAT A LOT OF
TIMES WE DON'T EVEN READ THE BIO
SKETCH.
I HATE TO ADMIT TO MANY OF YOU
BUT I'M POINTING OUT SOMETHING
THAT MANY OF YOU ALREADY KNOW.
WE GO BY REPUTATION OFTEN.
MOST PEOPLE KNOW EACH OTHER AND
WE NEVER GET TO THE BIO SKETCH.
WE LOOK AT THE APPLICATION AND
WHERE IT'S COMING FROM AND MAKE
CONCLUSIONS RIGHT AWAY.
SO I THINK AND I DON'T KNOW IF
THERE'S AN EASY ANSWER TO BE
HONEST.
ONE WE NEED TO TAKE THE IDEA
FROM THE RESEARCH STUDY TO THAT
WOULD BE IMPLEMENTED AND TO
OTHERS.
AND THIS HAS IMPLICATIONS FOR
DEI OR A WAY TO ADVANCE THAT.
MAYBE MAKING THAT PART OF THE
PROPOSAL MAY BE ONE WAY TO DO IT
AND NOT EVERYBODY WILL SEE IT
AND SOMETHING TO CONSIDER.
>> THANK YOU SO MUCH.
I WOULD RESPOND THAT I THINK
MAYBE THE IDEA'S NOT THAT
CHANGING THE BIO SKETCH CAN
DRIVE CHANGE BUT SHOULD BE A
REFLECTION OF OUR VALUES SO IF
WE FORMALLY BY INCLUDING AND
HIGHLIGHTING AND BEING EXPLICIT
ABOUT THE ACTIVITIES IT
REINFORCES VALUE WE SEEK TO
SUPPORT.
VALENTINA AND JEN.
I'M NOT SURE IF EITHER ARE READY
GO NOW, PLEASE, JUMP IN.
>> JEN.
>> I AGREE WITH WHAT SAID IS
SAYING BUT I DO SEE VALUE IN
TERMS OF HAVING SOMETHING ON A
BIO SKETCH.
SOMETIMES I PUT THIS IN MY
PERSONAL STATEMENT ABOUT WORK
I'VE DONE IN THIS AREA AND THAT
OPTION IS THERE AND ARE
INSTITUTIONS DOING THAT AND AT
MAYO WE PUT CONTRIBUTIONS IN
OPPORTUNITIES AND LOOKING AT THE
PORTFOLIO AND THERE'S A POINT
ABOUT THE MEASURE.
>> THERE'S IMPACT TO COLLECTIVE
TO INDIVIDUAL LAB.
WE'RE FOCUSSED ON LEGACY AND
INDIVIDUAL LABS AND I AGREE WITH
THAT.
THE CONVERSATION MEANS CAN WE
REWARD COST AND PAST INVESTMENT
TO MAKE IT THROUGH THE FILTER
AND CALL IT PRODUCTIVITY.
ARE WE READY?
BOTH ARE IMPORTANT.
I AGREE HAVING A THINK TANK AND
AND WE WILL NOT BE ABLE TO
TRANSITION FROM THE OLD WAY TO
NEW ONE.
MAYBE NIAMS COULD BE THE
BEGINNING BREWING ENVIRONMENT
FOR A PILOT KNOWING BEGINNING IN
THE OFFICE OF EQUITY AND
INCLUSION THEY COULD BE SETTING
UP SYSTEMS FOR HAVING THAT LENS
IN STUDY SECTION SO IT'S NOT
LEFT TO US TO REINFORCE THE SAME
METRICS AS THE PAST.
I'LL LOOK FORWARD FOR CONSENSUS
IN FUTURE CONVERSATION.
THANK YOU.
DID YOU WANT TO MAKE A COMMENT?
>> I'M DONE.
>> WE'RE EXACTLY NOW A MINUTE
OVER WHEN WE WERE GOING BEGIN A
BREAK.
SO UNLESS THERE ARE OTHER
COMMENTS FOLKS WANTED TO MAKE
NOW, THIS IS AN OPPORTUNITY TO
GET UP AND STRETCH YOUR LEGS AND
WALK AROUND.
I HOPE YOU WILL DO THAT AND NOT
SIMPLY LOOK AT YOUR E-MAIL INBOX
BUT THE PLAN RIGHT NOW IS TO
RECONVENE AT 12:15 EASTERN TIME
AND THEN WE'RE GOING TO SHIFT
GEARS AND HEAR A PRESENTATION
FROM DR. MIKE LAUER AND OTHERS
ABOUT THE MANAGEMENT POLICIES
AND NIAMS EFFORTS IN THIS AREA
AND AS A REMINDER TO THOSE IN
THE COUNCIL MORE THAN A COUPLE
MEETINGS WE HAVE HAD DISCUSSIONS
ABOUT DATA SCIENCE AS A BROAD
INITIATIVE NIAMS IS UNDERTAKING
IN COLLABORATION WITH COUNCIL
AND THIS IS A PIECE OF THAT.
GIVEN THE IMPLEMENTATION OF THE
GUIDELINES ON DATA SHARING WE
WANTED TO TAKE ADVANTAGE OF THAT
TIMING TO HAVE DISCUSSION AT THE
MEETING.
CATHY, WAS THERE ANYTHING ELSE
BEFORE WE BREAK?
>> NO, WE'RE READY AND RECONVENE
AT 12:15.
>>IT'S 12:15 SO WE'LL GET
STARTED.
AS MENTIONED BEFORE THE BREAK,
THE NEXT SECTION OF OUR MEETING
IS GOING TO BE DEVOTED TO
DISCUSSION OF A NUMBER OF ISSUES
RELATED TO DATA INCLUDING
IMPORTANTLY DATA SHARING AND
MANAGEMENT, WHICH WE'LL BEGIN
WITH AND THEN SOME OTHER DATA
SCIENCE RELATED TOPICS TO FOLLOW
THAT.
WHAT I'D LIKE TO DO IS INTRODUCE
OUR NEXT SPEAKER, DR. LAUER AND
OUR PANELISTS IN HOPES WE CAN
TRANSITION DIRECTLY INTO A PANEL
DISCUSSION AT THE END OF
DR. LAUER'S FORMAL PRESENTATION.
HE'LL KICK US OFF.
HE'S THE NIH DEPUTY DIRECTOR FOR
EXTRAMURAL RESEARCH AND HE'S
GOING PRESENT ON THE POLICIES
GOING INTO EFFECT EARLY NEXT
YEAR.
HE'S THE PRINCIPLE LEADER ON THE
EFFECTIVENESS OF THE EXTRAMURAL
RESEARCH PROGRAM AND
ADMINISTRATION.
A VERY IMPORTANT ROLE HE WENT TO
HARVARD MEDICAL SCHOOL, HARVARD
SCHOOL OF PUBLIC HEALTH AND THE
FRAMINGHAM HEART STUDY.
FROM 2007 TO 2015 HE SERVED AT
THE DIVISION DIRECTOR AT NHLBI
LOOKING AT EFFORTS TO ADOPT A
RESEARCH FUNDING CULTURE THAT
REFLECTED DATA-DRIVEN POLICY
HE'LL BE JOINED BY TWO
COLLEAGUES DURING THE PANEL
DISCUSSION.
DR. GREGURICK THE ASSOCIATE
DIRECTOR FOR DATA SCIENCE AND
UNDER DR. GREGURICK'S LEADERSHIP
THE OFFICE LEADS THE IMPLEM
IMPLEMENTATION OF DATA SCIENCE
THROUGH SCIENTIFIC, TECHNICAL
AND INSTITUTES AND CENTERS AND
OFFICES ACROSS THE NIH.
DR. GREGURICK WAS INSTRUMENTAL
IN THE OFFICE OF DATA SCIENCE
STRATEGY IN 2018 AND SERVED AS
THE SENIOR ADVISORY TO THE
OFFICE UNTIL NAMED TO HER
CURRENT POSITION.
SHE RECEIVED HER UNDERGRADUATE
IN CHEMISTRY AND MATHEMATICS
FROM THE UNIVERSITY OF MICHIGAN
AND HER Ph.D. IN PHYSICAL
CHEMISTRY FROM THE UNIVERSITY OF
MARYLAND.
YES AND SHE SERVED IN BIOMEDICAL
TECHNOLOGY AND AT THE NATIONAL
INSTITUTES AND AND THE ACTING
DIRECTOR OF THE OFFICE OF
SCIENCE POLICY AT THE NIH.
IN THIS POSITION SHE ADVISES
SENIOR LEADERSHIP IN
CROSS-CUTTING BIOMEDICAL
POLICIES AND PROGRAMS CONSIDERED
HIGH PRIORITY TO NIH AND THE
UNITED STATES GOVERNMENT.
PRIOR SHE SERVED AS DEPUTY
DIRECTOR OF THE OFFICE OF
SCIENCE POLICY.
DR. JORGENSON ALSO SERVED AS THE
DEPUTY EXECUTIVE DIRECTOR OF THE
WHITE HOUSE CANCER MOON SHOT
TASK FORCE IN THE OBAMA
ADMINISTRATION WHERE SHE
DIRECTED AND COORDINATED
CANCER-RELATED ACTIVITIES ACROSS
THE FEDERAL GOVERNMENT AND
WORKED TO LEVERAGE ACROSS SECTOR
TO ACCELERATE PROGRESS IN CANCER
PREVENTION.
SHE EVERYBARNED HER BACHELOR'S E
FROM DENNISON UNIVERSITY.
WE HAVE HIGHLY QUALIFIED EXPERTS
JOINING US FOR THE NEXT SECTION
OF OUR COUNCIL MEETING AND I'M
SO GRATEFUL.
AT THIS POINT, I'M GOING TO TURN
THINGS OVER TO DR. LAUER FOR HIS
PRESENTATION FOLLOWED BY OUR
PANEL DISCUSSION.
>> THANK YOU VERY MUCH.
I WANT TO CONFIRM YOU'RE HEARING
ME OKAY.
>> YES.
>> I WANT TO TAKE THE
OPPORTUNITY TO THANK MY
COLLEAGUES IN PARTICULAR OUR
PANEL FOR PUTTING THIS TOGETHER.
THIS IS THE TEAM EFFORT FOR MANY
OFFICES ACROSS THE NIH.
DATA SHARING IS HIGH PRIORITY
WITHIN THE U.S. GOVERNMENT.
IN FACT I THINK IT'S FAIR TO SAY
THAT SHARING OF SCIENTIFIC DATA
IS A HIGH PRIORITY LITERALLY TO
THE VERY HIGHEST LEVEL OF
GOVERNMENT IN THE UNITED STATES.
WHEN JOE BIDEN WAS VICE
PRESIDENT HE PLAYED A MAJOR ROLE
IN THE CANCER MOON SHOT.
A TOP PRIORITY WAS ENHANCING AND
NURTURING THE CULTURE OF DATA
SHARING.
IN ADDITION, DATA SHARING IS
EXPLICITLY CALLED OUT IN STATUTE
IN THE 21st CENTURIES CURES ACT
IN 2016, THERE'S A PROVISION
THAT SAYS THE NIH MAY REQUIRE
RECIPIENTS OF NIH AWARDS TO
SHARE SCIENTIFIC DATA TO THE
EXTEND FEASIBLE GENERATED FROM
SUCH NIH AWARDS.
SO DATA SHARING POLICIES GO BACK
EVEN FURTHER.
BACK IN 2003, NIH ISSUED
POLICIES APPLYING TO ALL GRANTS
THAT INCLUDE MORE THAN $500,000
OF DIRECT COST IN ANY GIVEN
YEAR.
IN THE LATE 2000s WE ISSUED THE
GENOME WIDE ASSOCIATION STRATEGY
AND DATA SHARING POLICIES.
IN 2014 THE GENOMIC DATA SHARING
POLICY WAS ISSUED.
IN 2016, WE ISSUED A SUITE OF
POLICIES GOVERNING CLINICAL
TRIALS INCLUDING REQUIREMENTS
FOR REGISTRATION AND REPORTING
OF RESULTS.
THERE'S ALSO A NUMBER OF
POLICIES ACROSS PROGRAMS AND
SPECIFIC I.C.s ACROSS THE NIH.
THIS POLICY ISSUED IN 2020 AND
GOING TO BECOME EFFECTIVE IN
JANUARY 2023, HAS GONE THROUGH A
LONG ARC OF ITERATION.
GOING BACK TO 2016 THE YEAR THE
21st CENTURY CURES ACT WAS
PASSED.
AND A NUMBER OF PROPOSALS FOR.
WE RECEIVED QUITE A BIT OF
PUBLIC COMMENT AND THE POLICY
WE'RE TALKING ABOUT TODAY WAS
ISSUED IN OCTOBER OF 2020.
WE DELIBERATELY THEN ALLOWED FOR
A FAIRLY LONG PERIOD OF TIME TO
GO BY.
THE POLICY IS SIMPLE.
FOR ANY APPLICATION WHICH
INVOLVES A GENERATION OF DATA,
THERE NEEDS TO BE A DATA
MANAGEMENT AND SHARING PLAN.
AND WE RECOGNIZE WE FUND A WIDE
DIVERSITY OF SCIENCE.
THE KIND OF DATA SHARING PLAN
THAT MAY BE APPROPRIATE FOR A
PHASE III CLINICAL TRIAL MAY BE
DIFFERENT FROM A BASIC IMAGING
STUDY, FOR EXAMPLE.
WHAT WE'RE ASKING INVESTIGATORS
AND APPLICANTS TO DO IS TO
SUBMIT A MANAGEMENT AND SHARING
PLAN.
THAT PLAN WILL GO THROUGH AN
ASSESSMENT PROCESS WE'LL TALK
ABOUT.
ONCE THE PLAN IS APPROVED, THAT
PLAN THEN BECOMES PART OF THE
GRANT AWARD ITSELF OR THE AWARD
ITSELF AND SO THE SECOND PART OF
THE DATA MANAGEMENT AND SHARING
POLICY IS THERE NEEDS TO BE
COMPLIANCE WITH THE PLAN AGREED
UPON.
TWO COMPONENTS ONE IS A DATA
MANAGEMENT AND SHARING PLAN AND
ONES -- ONCE APPROVED
COMPLIANCE WITH THE DATA PLAN.
WE UNDERSTAND THERE'S
LIMITATIONS.
THIS INCLUDE TECHNOLOGY, ETHICAL
AND LEGAL FACTORS AND THERE'S
CONCERN ABOUT PRIVACY AND
CONFIDENTIALITY AND THERE'S ALSO
LAWS, REGULATIONS AND OTHER
POSITIONS NEED TO BE CONSIDERED
BUT NONETHELESS HAVING PUTTING
THAT ASIDE THE ASSUMPTION IS
EVERY EFFORT WILL BE MADE TO
SHARE DATA AND DATA SHARING AND
IT'S SOMETHING THAT SCIENTISTS
SHOULD BE THINKING ABOUT FROM
THE BEGINNING.
AND WE UNDERSTAND AS WITH ALL
SCIENCE THAT THINGS MAY CHANGE
AS ONE MOVES ALONG.
AND IT'S POSSIBLE DATA
MANAGEMENT AND SHARING PLANS
WILL BE ALTERED OR AMENDED AS
TIME GOES ON.
THAT'S SOMETHING THAT WILL BE
DONE IN COORDINATION WITH THE
AGENCY AND CERTAINLY SOMETHING
WE EXPECT WILL HAPPEN IN MANY
CASES WILL BE COMPLETELY
APPROPRIATE.
THE EXACT PROCESS IS STILL
UNDERGOING FINAL REVIEW AND
CLEARANCE.
BUT IT'S GOING TO LOOK SOMETHING
LIKE THIS.
A PLAN SUBMITTED WITH THE
APPLICATION THAT WILL CONSISTENT
IN ALL LIKELIHOOD TWO PARTS.
ONE IS A DOCUMENT THAT WILL
PROBABLY BE ABOUT THREE PAGES
LONG AND THEN THE SECOND IS A
BRIEF SUMMARY OF A PLAN WHICH
WILL APPEAR IN THE BUDGET
JUSTIFICATION.
THAT'S VERY IMPORTANT BECAUSE WE
RECOGNIZE THAT DATA MANAGEMENT
AND DATA SHARING IS NOT FREE.
THERE ARE REAL COSTS AND
LEGITIMATE COSTS ASSOCIATED WITH
THAT AND WE WANT SCIENTIST AND
WE WANT GRANT ADMINISTRATORS TO
BE THINKING ABOUT THAT AS THEY
PUT THEIR APPLICATIONS TOGETHER.
NOW, THEN WHAT WILL HAPPEN IS
THE APPLICATIONS WILL COME IN
AND PEER REVIEWERS WILL BE ASKED
TO COMMENT ON THE BUDGET
COMPONENT WHETHER OR NOT THE
BUDGET IS BEING REQUESTED IS
REASONABLE.
BUT THE PRIMARY ASSESSMENT
WHETHER THEY MEET COMPLIANCE
WILL BE ON NIH STAFF.
ONCE THE PLAN IS AGREED UPON AND
INCORPORATED IN THE AWARD IT
WILL BE MONITORED AT REGULAR
INTERVALS PROBABLY FOR MOST
GRANTS THROUGH THE PROGRESS
REPORTS AND OF COURSE PLANS CAN
BE REVISED AS TIME GOES ON AS
APPROPRIATE.
COMPLIANCE AND THERE'S ISSUES
AND THERE'LL BE PROBLEMS WITH
NON COMPLIANCE THAT MAY FACTOR
INTO FUTURE FUNDING DECISIONS.
THERE'S A NUMBER OF QUESTIONS WE
HAVE RECEIVED.
ONE OF THE MOST IMPORTANT ONES
IS WHAT IS DATA.
WHAT DATA NEEDS TO BE MANAGED
AND SHARED AND WHAT NEEDS TO BE
EXPLICITLY DISCUSSED IN THE DATA
MANAGEMENT AND SHARING PLAN.
WE DEFINE AS SUFFICIENT QUALITY
TO VALIDATE AND REPLICATION
RESEARCH FINDINGS.
THAT'S WHAT NEEDS TO BE
INCLUDED.
THIS DOES NOT INCLUDE LABORATORY
NOTE BOOKS.
IT DOES NOT INCLUDE PRELIMINARY
ANALYSES AND CASE REPORT FORMS
OR PHYSICAL OBJECTS.
DATA SHOULD BE MADE ACCESSIBLE
AS SOON AS POSSIBLE AND
TYPICALLY THAT WOULD MEAN AT THE
TIME OF PUBLICATION OR WHEN A
PROJECT COMES TO AN END AND
CONSIDERATION SHOULD BE MANAGED
HOW DATA SHOULD BE SHARED AND
MAY BE CONSIDERATIONS TO GO INTO
THAT.
RIGHT NOW WE ARE ENGAGING IN
OUTREACH AND COMMUNICATION AND I
WANT TO POINT OUT OUR WEBSITE,
OPEN MIC.
I ALSO WANT TO POINT OUT
DR. JORGENSON'S WEBSITE AND
THERE'S ALREADY QUITE A BIT OF
MATERIAL ABOUT DATA SHARING IN
BOTH PLACES BUT I'VE GOT MORE ON
THAT IN A MOMENT.
WE HAVE BEEN GIVING WEBINARS AND
PUTTING OUT FAQs.
SOME COUNCIL SESSIONS LED TO
ADDITIONAL FAQs.
WE HAVE A DRAFT GUIDANCE FOR
RESEARCHERS WORKING WITH
AMERICAN INDIANS AND ALASKAN
NATIVES.
THERE'S BE ADDITIONAL
SUPPLEMENTAL INFORMATION PUT OUT
FOR PEOPLE DOING GENOMIC DATA
SHARING, THERE WILL ONLY BE ONE
PLAN.
WE'RE NOT ASKING PEOPLE TO
SUBMIT A GENERAL DETE SHARING
PLAN AND GENOMIC DATA SHARING
PLAN.
WE'RE HOPING TO PUT OUT SAMPLE
PLANS AND WHAT THE TIMING OF
THAT WILL BE IS STILL SOMETHING
WE'RE THINKING ABOUT WE HAD AN
INTERESTING EXPERIENCE WITH
AUTHENTICATION OF RESOURCE AND I
WAS IN EFFORT TO ENHANCE RIGOR
AND REPRODUCIBILITY IN RESEARCH.
AT A POINT WE PUT OUT EXAMPLES
OF HIGH QUALITY AUTHENTICATION
PLANS.
WE HAVE TO BE CAREFUL.
ON THE WITH ONE HAND WE WANT TO
PROVIDE PEOPLE WITH EXAMPLES OF
BENCHMARKS AND WE ALSO DON'T
WANT PEOPLE FEELING BOXED IN.
ONCE THE POLICY'S IMPLEMENTED WE
ANTICIPATE AN ONGOING LEARNING
PROCESS.
WE'LL BE ASSESSING THE POLICY
FOR SHORT-TERM AND LONG-TERM
GOALS AND ONE INTERESTING ISSUE
ARE INCENTIVES FOR DATA SHARING.
A NUMBER OF PEOPLE THOUGHT LONG
AND HARD AND WONDER ON WAYS TO
MAKE DATA SHARING AS NATURAL AND
DESIRED AS PUBLICATION.
AND SCIENTISTS WOULD WANT TO
SHARE THEIR DATA BECAUSE IT
REFLECT WELLS ON THE WORK
THEY'RE DOING.
REFLECTS WELL ON THE WORK
THEY'RE DOING.
I WANTED TO TELL YOU ABOUT A NEW
RESOURCE WE HAVE PUT UP.
IT'S CALLED SHARING DOT NIH.gov.
LAUNCHED A NUMBER OF WEEKS AGO.
THIS IS A PLACE WHERE WE HAVE A
LOT OF INFORMATION AND RESOURCES
NOT ONLY ON THE ALSO WE'RE
TALKING ABOUT NOW BUT ON OTHER
POLICIES AS WELL.
YOU CAN GO TO THE SITE AND FIND
INFORMATION ABOUT SCIENTIFIC
DATA AND SHARING POLICIES ON
GENOMIC DATA AND CLINICAL TRIALS
AND OPEN ACCESS AND A VARIETY OF
OTHER TOPICS.
THE OTHER THING YOU CAN DO IS
THERE'S A TOOL ON THE BOTTOM A
BUTTON THAT SAYS FIND WHICH
POLICIES APPLY TO YOU SO THERE'S
A TOOL THAT YOU CAN USE TO
FIGURE OUT WHICH POLICIES APPLY
TO A PROJECT YOU'RE PROPOSING.
THE SITE HAS A FAIRLY SIMPLE
STRUCTURE.
IT'S SIMPLE IN STRUCTURE BUT
RICH IN CONTENT.
I WANT TO THANK MANY COLLEAGUES
WHO PUT A HUGE AMOUNT OF WORK IN
PUTTING THIS THING TOGETHER.
THE DATA MANAGEMENT AND SHARING
POLICY INCLUDING THE POLICY WE
HAVE NOW AND THE POLICY THAT
WILL COME INTO PLAY IN JANUARY
2023.
THE GENOMIC DATA SHARING POLICY.
ONE GOAL IS TO HAVE AS MANY
RESOURCES AS POSSIBLE ALL IN ONE
PLACE.
VARIOUS OTHER SHARING POLICIES
INCLUDING POLICIES OF SPECIFIC
I.C.s.
THEN ACCESSING DATA FROM TO THE
OTHER POINT OF VIEW.
YOU'RE INTERESTED IN ACCESSING
DATA OTHER PEOPLE ARE INTERESTED
IN SHARING.
HOW DO YOU GO ABOUT DOING THAT
AND GETTING ACCESS TO THE DATA
AND IT.
-- AND USING IT.
THERE'S A NUMBER OF RESOURCE
HERE INCLUDING INFO GRAPHICS ON
POLICIES AND CERTAIN TYPES OF
TASKS STEP BY STEP INSTRUCTIONS.
FOR THE DATA MANAGEMENT AND
SHARING POLICY, WE HAVE THREE
MAJOR AREAS OF CONTENT.
ONE IS PLANNING AND BUDGETING.
HOW DO YOU PUT THE PLAN
TOGETHER?
HOW MUCH MONEY SHOULD BE
POTENTIALLY PUT INTO THIS.
THEN THERE'S SECTIONS ON DATA
MANAGEMENT AND DATA SHARING.
THIS HAS INFORMATION, FOR
EXAMPLE ON REPOSITORIES.
WHAT ARE THE CHARACTERISTICS OF
A GOOD REPOSITORY WHERE WE'D
LIKE DATA BEING SEEN PLACED.
YOU MAY HAVE REPOSITORIES
CREATED BY NIH OR USING THOSE
CREATED BY YOUR OWN OR
UNIVERSITY LIBRARYIES AND THERES
A FAIR AMOUNT OF INFORMATION
ABOUT THESE.
THIS IS A PERIOD OF TRANSITION.
AT THIS MOMENT WHILE WE'RE
SIGNATURE HERE THE MAIN DATA
SHARING POLICY WAS ISSUED IN
2003.
SO IF YOU WERE TO BE SUBMITTING
AN APPLICATION NOW OR LETS SAY
IN SEPTEMBER OR OCTOBER, YOU
WOULD BE USING THE GUIDANCE FOR
THE LONG STANDING DATA SHARING
POLICY.
SO THERE'S A BUTTON THAT WOULD
TELL YOU WHAT YOU NEED TO DO.
ON THE OTHER HAND, IF WE COME TO
JANUARY 2023 AND LATER, YOU
WOULD THEN PUSH THE BUTTON ON
THE RIGHT AND THAT WOULD GIVE
YOU INFORMATION WHAT TO DO
THERE.
THE KEY POINT IS WE RECOGNIZE
WE'RE DOING ARE IN A PERIOD OF
TRANSITION AND TRYING TO BE OPEN
AND COMMUNICATIVE AND MAKING
SURE PEOPLE HAVE THE RIGHT
GUIDANCE AS THEY PUT MATERIALS
TOGETHER.
WE HAVE NEWS AND EVENTS.
THERE'S WEBINARS COMING UP AND
NEW INFORMATION BEING POSTED.
WE ASK YOU CHECK IN EVERY SO
OFTEN AND PLEASE SHARE THIS WITH
YOUR COLLEAGUES AND STAFF.
WE WANT PEOPLE TO LOOK AT IT AND
PROVIDE FEEDBACK, TELL US WHAT'S
MISSING, PROVIDE US WITH
ADDITIONAL FAQs AND SO FORTH.
WE'RE HEARING A LOT OF QUESTIONS
AND MORE IN THE PANEL
DISCUSSION.
ONE IS HOW PRESCRIPTIVE WE ARE
AND FLEXIBILITIES AND WHERE'S
THE MONEY COMING FROM?
WE UNDERSTAND DATA MANAGEMENT
AND SHARING COSTS MONEY.
THAT'S THE REASON WHY WE
EXPLICITLY ASKED PEOPLE TO THINK
HARD AND ON THE LIBRARY OF
MEDICINE ENGAGED IN THE VERY
INTERESTING PROJECT THE NATIONAL
LIBRARY OF MEDICINE ENGAGED IN
AN INTERESTING PROJECT WITH THE
NATIONAL ACADEMIES ON THE COST
OF DATA SHARING AND THAT'S A
REPORT WIDELY AVAILABLE.
WILL IT BE PUBLIC?
YES.
AN HOW WILL NIH ENFORCE
COMPLIANCE IS AN INTERESTING
ONE.
THERE MAY BE A FAIR AMOUNT OF
COMMUNITY ENFORCEMENT OF
COMPLIANCE.
IF SAY A SCIENTIST IS NOT
SHARING DATA AS THEY INDICATE
THEY WOULD IN THEIR
PUBLICLY-POSTED PLAN WE MAY HEAR
ABOUT IT FROM SOMEBODY TRYING TO
GET ACCESS TO THE DATA.
THESE ARE MY CLOSING THOUGHTS.
IN MANY RESPECTS THERE'S NOTHING
NEW HERE.
DATA SHARING HAS LONG BEEN
EXPECTED.
AND DATA SHARING IS HIGH
PRIORITY IN THE GOVERNMENT AND
GOING TO THE HIGHEST LEVEL OF
GOVERNMENT TODAY.
KE BASKETBALL I AM FWEMENTI IIN
-- IMPLEMENTING THE POLICY WITH
LEARNING THEREAFTER AND A
REMINDER THE KEY POINTS HERE ARE
THAT THERE NEEDS TO BE A DATA
MANAGEMENT AND SHARING PLAN
SUBMITTED WITH APPLICATIONS.
THAT PLAN WILL BE ASSESSED BY
NIH STAFF AND ONCE THERE'S AN
AGREED UPON PLAN IT WILL BE A
CONDITION OF AWARDS AND THE
SECOND PART OF THE POLICY THAT
IS THEY'LL BE COMPLIANCE WITH
THE AGREED UPON PLAN.
THE POLICY PROVIDES INFORMATION
ABOUT THE KEY ELEMENTS OF DATA
MANAGEMENT AND BUDGETING AND
WHAT IS AN APPROPRIATE
REPOSITORY.
PAY ATTENTION TO OUR OUTREACH
OPPORTUNITIES AND THANK YOU FOR
BEING HERE AND THOSE ARE MY
OPENING REMARKS.
>> THANK YOU.
HELPFUL PRESENTATION AND
OVERVIEW AND THE ARC OF
ITERATION IS IMPRESSIVE
INCLUDING THE TIME AND EFFORTS
DEVOTED TO GETTING THE WORD OUT
AND PEOPLE UP TO SPEED AND
PROVIDING RESOURCES.
WE'RE NOW GOING TO MOVE INTO THE
PANEL DISCUSSION WHERE MEMBERS
OF PANEL CAN RAISE DISCUSSION
AND SUSAN CAN SHARE COMMON
QUESTIONS THEY'VE BEEN HEARING
BUT FIRST IF WE CAN HAVE SUSAN
RAISE A HAND SO PEOPLE CAN SEE
WHO YOU ARE.
BEFORE WE STARTED I SHARED HER
BACKGROUND AND HER
RESPONSIBILITIES AND THEN LYRIC
IF YOU CAN RAISE YOUR HAND.
I HAVE YOU ALL ACROSS TWO
SCREENS.
WE HAVE PLENTY OF TIME SET
ASIDE.
WE HAVE AN HOUR SET ASIDE FOR
QUESTIONS AND DISCUSSION RELATED
TO THESE ISSUES.
I'M GOING TO LOOK FOR HANDS TO
COME UP.
LUIS.
>> THANK YOU FOR THE GREAT
INTRODUCTION.
WE ALL AGREED IT'S AN IMPORTANT
EFFORT.
ONE YOU TALKED ABOUT
INVESTIGATORS AT THE INDIVIDUAL
LEVEL BUT I THINK RIGHT NOW WHAT
I'M HEARING AT HOPKINS, FOR
EXAMPLE, IS AMONG ADVISE DEANS
OF RESEARCH AND COMPLIANCE
OFFICERS ABOUT HOW ARE WE GOING
TO MAKE SURE WE'RE COMPLIANT.
DO YOU GUYS HAVE TOOL KIDS TO
MAKE SURE INSTITUTIONS CAN
FOLLOW ALONG TO WHERE THEY
SHOULD BE AT?
>> THIS IS LIKE FCOI PLAN AND WE
AGREE POINT AND IT'S YOUR
RESPONSIBILITY TO MAKE SURE I
FOLLOW YOUR OWN PLAN AND OUR
RESPONSIBILITY TO CHECK IN WITH
THERE'S CONCERNS.
WE ARE AND I'LL DEFER TO MY
COLLEAGUES IN A MOMENT.
WE'RE AWARE A NUMBER OF
INSTITUTIONS HAVE BEEN DOING
TERRIFIC WORK IN CREATING
REPOSITORIES AND TOOLS TO HELP
RESEARCHERS BE COMPLIANT NOT
ONLY WITH THIS POLICY BUT WITH
POLICIES FROM OTHER AGENCIES
INCLUDING THE NSF THAT'S A
POLICY LIKE THIS IN PLACE A LONG
TIME AS WELL AS PRIVATE
FOUNDATIONS LIKE THE GATES
FOUNDATION.
LET ME ASK MY COLLEAGUES TO
CHIME IN AS WELL.
>> YOUR QUESTION IS ONE THAT WE
CONSIDERED IN THE POLICY
DEVELOPMENT PROCESS.
WE SPENT A LOT OF TIME NOT ONLY
MEETING WITH ACTUAL
INVESTIGATORS AND EXPLICIT BEING
FEEDBACK FROM INSTITUTIONAL
LEADERSHIP AND TRACKING THE
EFFORTS.
WE MET WITH COUNCIL ON
GOVERNMENT RELATIONS AND MET
WITH STAKEHOLDERS TO MEET WITH
MPRs AND HAVE WORKED WITH
COLLEAGUES IN OER TO GO TO
REGIONAL SEMINARS TO MEET WITH
INSTITUTIONAL COMPLIANCE
OFFICERS AND MORE.
WE'VE DONE THIS IN THE LAST FIVE
YEARS IN THE DEVELOPMENT PROCESS
TO UNDERSTAND THE CHALLENGES AND
WHAT THEY MIGHT FACE WHICH
FRANKLY IS A LOT OF AROUND THE
HOW TO SUBMIT THIS INFORMATION
AND INTEGRATE INTO THE ACTUAL
GRANT APPLICATION PROCESSES.
AND AFTER THE FACT AS MENTIONED.
WE ALSO HAVE WORKED WITH OUR
PARTNERS HOSTING WORKSHOPS.
FOR INSTANCE, WE RECOGNIZE IT'S
GOING TO TAKE ALL OF US THE
ENTIRE RESEARCH ENTERPRISE TO
MAKE THAT CULTURE CHANGE THAT
WE'RE STRIVING FOR.
THE NATIONAL ACADEMIES COMMITTEE
NEEDS A WORKSHOP TO DISSEMINATE
BEST PRACTICES IN CASE STUDIES.
THERE'S AMAZING WORK GOING ON
THERE.
THOSE WHO HAVE BEEN DOING THIS
AND DOING THIS FOR A LONG TIME
SHARE THAT WITH THOSE THAT MAY
BE NEWER AND MAY HAVE CHALLENGES
IN IMPLEMENTATION TO HIT THE
GROUND RUNNING.
>> GREAT, THANK YOU.
SUSAN, WERE GOING ADD A COMMENT?
[TECHNICAL DIFFICULTIES]
AND THERE'S INFORMATION ABOUT
THE DATA LIFE CYCLE AND HOW TO
ENSURE YOUR DATA'S FAIR,
FINDABLE AND INTRAOPERABLE AND
REUSABLE AND I INVITE
RESEARCHERS TO LOOK WITHIN THEIR
COMMUNITIES AND WEBSITE FOR
ADDITIONAL TOOLS TO HELP DEVELOP
THEIR DATA MANAGEMENT PLANS.
>> THANK YOU SO MUCH, SUSAN.
>> MAYBE IF YOU CAN PUT THAT IN
THE CHAT.
THAT WOULD BE GREAT.
TWO MORE HANDS UP NOW.
STEWART, YOU ARE NEXT.
>> THANK YOU FOR THE
INFORMATION.
IT'S VERY IMPORTANT TO SHARE
DATA.
MY QUESTION PERTAINS TO WHAT
LOUIS HAS ALREADY BROUGHT UP.
IT LIKES LIKE THERE'S GOING TO
BE OBLIGATIONS AT THE
INVESTIGATOR LEVEL AND
INSTITUTIONAL LEVEL AND AT THE
NIH LEVEL.
AND PUTTING IN A GRANT IS A BIG
ADMINISTRATIVE BURDEN FOR AN
INVESTIGATOR ESPECIALLY IF
YOU'RE A CLINICAL SCIENTIST OR
INVESTIGATOR.
AND I'M WONDERING FOR THE
AVERAGE GRANT HOW MUCH TIME DO
YOU THINK IT'S GOING TO TAKE TO
COMPLETE THIS ANALYSIS AND PUT
THE DOCUMENT IN A WAY THAT WILL
BE VERY CLEAR TO THE INSTITUTION
AND NIH THAT YOU'RE FULFILLING
THE AIMS NIH WANTS FOR THE
SECTION?
>> I CAN START WITH THAT.
IT'S A GREAT QUESTION.
ESSENTIALLY THE DATA SHARING AND
MOST QUESTIONS ARE QUITE
STRAIGHTFORWARD.
WE'RE PROVED CLEAR CUT TEMPLATE.
IT WILL RANGE FOR DIFFERENT
KINDS OF SCIENTISTS.
FOR A NUMBER OF CLINICAL
SCIENTISTS, THIS MAY NOT REQUIRE
THAT MUCH WORK AT ALL BECAUSE
THIS MAY BE SOMETHING THEY'RE
DOING ALREADY.
THERE'S A NUMBER OF JOURNALS
THAT REQUIRE DATA SHARING AND
THERE'S A DOCUMENT THAT
DESCRIBES HOW THE DATA SHARING
IS GOING TO BE DONE.
AND FOR OTHERS THIS MAY BE ALL
BRAND NEW.
THAT'S SOMETHING WILL REQUIRE
SOME WORK.
AND LYRIC PUT IN THE CHAT THE
AVERAGE DATA SHARING WILL BE TWO
TABLES.
WE HOPE BEFORE TOO LONG THIS IS
GOING TO BE LESS BURDENSOME FOR
PUTTING TOGETHER A BIO SKETCH
ESPECIALLY FOR THOSE ALREADY
ENGAGED IN THE PRACTICE.
I RECENTLY PUBLISHED PAPERS AND
YOU HAVE TO SHARE YOUR DATA.
THEY MAKE THAT CLEAR.
BY VIRTUE OF GOING THROUGH THAT
PRACTICE IF I HAD TO FILL
SOMETHING LIKE THIS OUT IT
WOULDN'T BE THAT HARD.
I THINK IT WILL VARY.
>> IT'S GREAT TO KNOW AND THAT'S
GREATS.
IF THERE'S NO MORE RESPONSES,
MARIA HAS A QUESTION NOW.
>> THANK YOU VERCH -- VERY
INFORMATIVE PRESENTATION.
I'M WONDERING IF YOU CAN EXPAND
MORE HOW COMPLIANCE WILL BE
ENSURED?
IS THIS GOING TO BE PRIMARILY
SELF-REPORT OR AUDAUDITS?
WHAT ARE THE PENALTIES FOR LACK
OF COMPLIANCE.
AND HOW IS ALL OF THAT GOING TO
BE EVALUATED AND I GUESS AT THE
END ENFORCED?
>> THAT'S ANOTHER GREAT
QUESTION.
PART OF THIS WILL BE THROUGH
PROGRESS REPORTS.
SINCE AS PART OF THE PROPOSAL
YOU'LL SAY WE'LL MANAGE AND
SHARE DATA IN A PARTICULAR WAY.
ARE YOU HEARING ME?
>> YES.
>> MY SCREEN SUDDENLY FROZE.
SO AS PART OF THE PROPOSAL, YOU
INDICATE THAT YOU'RE GOING TO
MANAGE AND SHARE DATA IN A
PARTICULAR WAY.
PART OF YOUR PROGRESS REPORT
WILL BE EXPECTED TO DESCRIBE
WHAT EXACTLY IS HAPPENING.
AND IF YOU HAVEN'T GENERATED
DATA YET NOTHING MAY HAVE
MANAGED YET OR HAVE
COMPLICATIONS BUT YOU'LL
INDICATE IN THE PROGRESS REPORT
WHAT HAS BEEN HAPPENING.
THAT'S ONE WAY IN WHICH
COMPLIANCE WILL OCCUR.
WE ARE PLANNING ON PUBLICLY
POSTING PLANS.
WHAT THAT WILL LOOK LIKE, WE
DON'T KNOW BUT FOR EXAMPLE A
PLAN MAY BE POSTED ON REPORTING.
AND A REPORT ON PUBLICATIONS.
WE MAY ALSO HAVE DATA MANAGEMENT
AND SHARING PLAN.
THERE, THE WAY THE COMPLIANCE
MAY HAPPEN IS THAT INTERESTED
SCIENTISTS WILL SEE THAT AND
WILL THEN CONTACT YOU AND SAY
WE'D LIKE AND INTRIGUED BY YOUR
STUDY AND WOULD LIKE TO HAVE
ACCESS TO THE DATA.
IF THE DATA MANAGEMENT AND
SHARING PLAN MAY SAY FOR PEOPLE
INTERESTED IN THE DATA YOU GO TO
X, Y, Z SITE AND THEY'LL GO
AHEAD AND DO IT.
THAT BRINGS ME TO ANOTHER WAY IN
WHICH COMPLIANCE MAY HAPPEN
WHICH IS THROUGH COMPLAINTS.
WE GET COMPLAINTS ON A VARIETY
OF ISSUES.
I'M IMAGINING HERE COMPLAINTS
MAY COME FROM THE SCIENTIFIC
COMMUNITY THEMSELVES AND MAY BE
A FORM OF SELF-REGULATION
HAPPENING HERE.
I DO GET COMPLAINTS EVERY SO
OFTEN.
I'VE BEEN AT NIH NOW 15 YEARS
AND THE COMPLAINTS HAVE BEEN
COMING IN THE LAST 15 YEARS.
EVERY SO OFTEN I'LL GET A
COMPLAINT FROM SOMEBODY SAYING
YOUR AGENCY FUNDED THIS PROJECT
AND PUBLISHED IN A PRESTIGIOUS
JOURNAL BUT THE SCIENTIST
REFUSING TO SHARE THEIR DATA
WITH ME.
THAT'S NOT MUCH TO SAY.
KNEW THEY'LL BE PART OF THE
TERMS AND CONDITIONS AND WARD,
THAT WILL TAKE COMPLIANCE AND
MAY BE ANOTHER COMPONENT OF
COMPLIANCE.
FOR THOSE SITUATION WHERE'S
THERE'S EGREGIOUS NON-COMPLIANCE
WE HAVE A VARIETY OF REMEDIES
AVAILABLE TO US.
WE CAN SUSPEND THE GRANTS AND
CAN HAVE SPECIAL AWARD
CONDITIONS.
IS THIS SHOULD BE VERY RARE.
WE WOULD NOT NEED TO GET TO THAT
PARTICULAR POINT.
>> WE HAVE BUILT COMPLIANCE IN
THE POLICY AND THAT'S AN
IMPORTANT COMPONENT OF MAKING
SURE IT HAS TEETH AT THEN OF THE
DAY BUT THE REAL GOAL IS
INCENTIVIZING A CULTURE SHIFT.
WE BUILT IN THE COMPLIANCE AND
HELPED MAKE THIS EASY AND MAY BE
JUSTIFIABLE LIMITATIONS TO
SHARING.
I WANTED TO MAKE SURE WE KNEW
THAT.
WITH THE TOP ETHICAL AND LEGAL
FACTORS CAN BE JUSTIFIED IN YOUR
PLAN AND YOU'VE OUTLINED IT IN
ADVANCE SAYING HERE'S THE ISSUES
WITH SHARING THE DATA SO PEOPLE
KNOW IT AND EXPECT IT AND IT CAN
BE BUILT IN IN ADVANCE SO IT
DOESN'T SHOW AT THE 24th HOUR
AND CAUSE CONSTERNATION WITH
COMPLIANCE.
>> THANK YOU VERY MUCH.
I WAS GOING TO ASK ABOUT
INCENTIVES AND HOW YOU'RE
THINKING ABOUT THAT.
RELATED TO THAT AND TOUCHING
UPON A TOPIC THAT CAME UP
EARLIER IN OUR COUNCIL MEETING,
I'M WONDERING WHAT YOUR THOUGHTS
ARE ABOUT MOVING TOWARDS A
CULTURE IN WHICH SHARING DATA IS
PROMINENTLY RECOGNIZED, CREDIT
IS ACKNOWLEDGED, ETCETERA.
WE WERE TALKING EARLIER ABOUT
HOW THERE'S STILL SO MUCH
EMPHASIS ON INVESTIGATOR-DRIVEN
STUDIES AND FIRST IN SENIOR
AUTHOR PUBLICATIONS.
DATA SHARING IS A SERVICE TO THE
RESEARCH COMMUNITY, INCREDIBLY
IMPORTANT.
WE WANT TO MAKE SURE IN ADDITION
TO COMPLIANCE WE HAVE INCENTIVES
AND RECOGNITION.
WOULD LOVE TO HEAR FROM THE
THREE OF YOU YOUR THOUGHTS ON TO
MOVE FURTHER IN THAT DIRECTION.
I GUESS THE INSTITUTIONS ARE AN
IMPORTANT PLAYER IN THIS AS
WELL.
>> I CAN START THINKING ABOUT
THIS WHEN WE WERE DESIGNING THE
POLICY.
OUR GOAL OF OUR POLICY AGAIN IS
TO HAVE DATA SHARING NOT
SOMETHING THAT IS INTEGRAL TO
THE PART OF THE RESEARCH CONCEPT
ITSELF.
I THINK MANY RECOGNIZE
PUBLISHING THE FINDS IS INTEGRAL
AND SO IS SHARING DATA NOT ONLY
FOR THE INFORMATION AND VALUE TO
THE PUBLIC BUT REPRODUCIBILITY
AND RIGOR AND PART OF WHAT WE'RE
DOING IS CONVENING OTHERS SUCH
AS INSTITUTIONS, FUNDERS AND
MORE TO FIGURE OUT WHERE THE
INCENTIVES LIE OUTSIDE THE
GOVERNMENT AND WHERE THEY LIE IN
THE GOVERNMENT.
FROM OUR PERSPECTIVE, AND AGAIN
I'LL TURN TO MIKE AND SUSAN,
MAKING THIS AS EASY AND READILY
ACCESSIBLE THROUGH
INFRASTRUCTURE IS ONE OF THE KEY
COMPONENTS.
THINKING ABOUT SYSTEM
IDENTIFIERS IS SOMETHING THE
ENTIRE FEDERAL GOVERNMENT IS
THINKING ON AND HOW TO SITE DATA
LIKE YOU DO A PUBLICATION AND
PEOPLE GOOD AT GENERATING AND
SHARING HIGH DATA SETS ARE
REWARDED AND CONSIDERED FOR
PROMOTION AND THOSE WHO HAVE THE
ROLE IN THE LAB TO HAVE THAT
CREDIT.
WE'RE WORKING ON HOW TO HAVE
THESE AS IMPORTANT COMPONENTS OF
HOW WE SHARE DATA AND SUSAN, I'D
LOVE TO TURN TO YOU TALK ABOUT
THE INFRASTRUCTURE YOU'RE
ESTABLISHING.
>> THANK YOU, ERIK.
>> THIS IS A CRITICAL PART OF
WHAT THE DATA STRATEGY IS
WORKING ON WITH COLLEAGUES.
AND PROVIDING DIGITAL OBJECT
IDENTIFIE
IDENTIFIESER WE HOPE TO HAVE
SOMETHING IN PLACE AS EARLY AS
THIS FALL.
THAT'S ONE WAY TO BEGIN TO
INCENTIVIZE RESEARCHERS TO GET
CREDIT FOR THEIR SHARING OF DATA
BY MAKING IT EASILY IDENTIFIABLE
AND CITABLE BY OTHER
RESEARCHERS.
AND IMPLEMENTED A DATA SHARING
AND RE-USE SEMINAR.
EACH YEAR WE HIGHLIGHT DIFFERENT
INSTITUTE AND CENTERS AT NIH AND
THEIR DATA SHARING PROGRAMS AND
IMPORTANTLY THE RESEARCHERS
FUNDED BY THOSE INSTITUTES TO
GIVE EXAMPLES OF HOW THEY SHARE
DATA AND A FANTASTIC RESOURCE
AND TALKED ABOUT THE ADVENTURES
OF THE DATA PARASITE A
COLLOQUIAL AWARD AND PUTTING
THAT TOGETHER TO ACCELERATE
CLINICAL RESEARCH.
AND SHARING MICROSCOPIC DATA.
THERE'S WAYS TO INCENTIVIZE DATA
SHARING.
I'LL MENTION WE HAVE A
PARTNERSHIP FOR A DATA SHARING
PRIZE AND WE'LL AWARD UP TO 10
RECOGNIZING TEAMS THAT HAVE DATA
REUSE BEST PRACTICE.
THERE'S OVER $45,000 IN THE
PRIZE PURSE FOR 12 PRIZES.
THAT CLOSES ON JULY 19.
YOU NEED TO REGISTER BY THE END
OF JUNE TO BE COMPETITIVE FOR
THE PRIZE.
I CAN PUT THAT IN THE CHAT AS
WELL.
I THINK THERE'S A LOT OF
DIFFERENT WAYS WE CAN
INCENTIVIZE AND REWARD
RESEARCHERS FOR SHARING DATA.
CERTAINLY CITING THE DATA AND
MAKING IT CITABLE AND FINDABLE
AND SHARING SUCCESS STORIES OF
RESEARCHERS SHARE DATA AND
GIVING CREDIT TO THEM AND THEIR
INSTITUTIONS AND OUT OF THE BOX
IDEAS FOR CHALLENGE AND PRIZES
FOR DATA SHARING.
>> I'LL PUT INTO THE CHAT AN
INTERESTING ARTICLE IN THE NEW
ENGLAND JOURNAL OF MEDICINE AND
BASED ON THE DATA REPOSITORY IN
PLACE FOR A LONG TIME AND HOW
OFTEN DATA BEING SHARED FROM THE
EPIDEMIOLOGICAL STUDIES WERE
BEING USED AND WAS REMARKABLY
HIGH.
THERE WERE A NUMBER OF PAPERS
THAT CAME FROM THERE.
WHEN I WAS A JUNIOR INVESTIGATOR
I TOOK ADVANTAGE OF THE
REPOSITORY AND REMEMBER AND
DEALT WITH TOPICS WITH WHAT THE
INVESTIGATORS DIDN'T HAVE IN
MIND.
AND YOU CAN WRITE AN ARTICLE
ABOUT A DATA SET NOT EXPERIMENTS
OR STUDIES YOU DID BUT INSTEAD
YOU DESCRIBE THE DATA SET AND
IT'S AN ARTICLE AND IT'S A GREAT
WAY TO THE RESOURCE IS OUT THERE
AND GET PEOPLE TO USE IT FOR
WHICH SCIENTISTS COULD GET
CREDIT.
>> THOSE ARE ALL GREAT ADDITIONS
AND I LOVE THE PRIZE IDEA.
THERE'S A QUESTION TO POSE.
>> MY QUESTION IS WHETHER
THERE'S FUTURE PLANS.
I APPRECIATE THE FOCUS AND ARE
THERE PLANS TO SHARE DATA WITH
PATIENTS IN CLINICAL STUDIES AND
THE EFFORTS UNDERTAKEN BY THE
ALL OF US INITIATIVE.
>> PART OF THE DATA SHARING
POLICY HERE MAKES THE DATA
AVAILABLE REGARDLESS OF WHO IS
USING IT AND THERE'S SOME
RESTRICTIONS BUT WE HAVE BEEN
EXPLORING SCALE-UP MODELS OF
WHAT WE CALL RESEARCH OF RRP
RESULTS AT SOME LEVEL TO
PARTICIPANTS AND WE HAVE BEEN
WORKING ON.
THERE'S REPORTS ON HOW TO DO
THIS ETHICALLY AND RESPONSIBLE
AND GIVING PEOPLE RESEARCH
RESULTS IS WHAT WE CONSIDER A
HALLMARK OF RESPECTING AUTONOMY
AND FROM PARTICIPANTS WHAT ARE
GIVEN THEIR TIME AND EFFORT TO
RESEARCH STUDIES.
THERE'S CONCERNS OF GIVING BACK
TO QUESTIONABLE VALIDITY OR LACK
OF ACTIONABILITY AND IS
SOMETHING WE ARE PURSUING.
I BELIEVE AT THE NIEHS COUNCIL
WE'RE LEARNING FROM THOSE WORKS
PUTTING TOGETHER A BROADER
FRAMEWORK IN ACCORDANCE WITH
ACADEMY RECOMMENDATIONS.
>> MY CAMERA IS NOT WORKING BUT
I HAVE TWO QUESTIONS.
IF THE POLICY RESULTS IN SHARING
RESTRICTING DATA WHICH COULD BE
SAY IMAGE DATA, WILL THE DATA
USE LIMITATION NEGOTIATION BE
SIMILAR TO WHAT IT CURRENTLY IS
FOR GENOMIC DATA AND WILL IT BE
UP TO ACCESS REQUEST FOR A MORE
CENTRALIZED EFFORT?
WE'RE LOOKING AT PLANS FOR THE
DATA WHICH INCLUDES THINKING
ABOUT WHETHER OR NOT DATA SHOULD
BE IN CONTROLLED ACCESS
SETTINGS.
WHAT THE PROCESS LOOKS LIKE.
FOR THOSE FAMILIAR WITH THAT,
SOME ONLY THE GENOMIC DATA
SHARING POLICY REQUIRES THE USE
OF THAT.
THERE'S CONSIDERATIONS WHETHER
IT'S APPLICABLE TO OTHER MODELS.
I KNOW SUSAN IS WORKING ON THIS
AND RECENTLY HAS DONE WORK ON
TALKING ABOUT WHERE WE'RE
HEADING.
>> GREAT QUESTION.
SOME ACTIVITIES WE'RE BEEN
WORKING ON FOR THE PAST YEAR
FOLLOW THE THREAT OF
STREAMLINING ACCESS TO
CONTROLLED ACCESS DATA AND DO
INCLUDE STANDARDIZING COMPONENTS
OF THE DATA USE LIMITATION FORM
AS WELL AS STANDARDIZING
COMPONENTS OF THE DATA REQUEST
OR ACCESS AND LOOKING AT THE
REQUEST TO ACCESS DATA THAT DOES
GO BEYOND GENOMICS DATA.
THAT MAY NOT COME TO A SINGLE
DAC BUT RESPECTING THE AUTHORITY
OF THE CURRENT DAC SYSTEMS IN
PLACE BUT OFFERING AS MUCH
AUTOMATION AS WE CAN AND
ENHANCING THE COMPETITION TO GET
ACCESS TO DATA FOR RESEARCHERS
IN A TIMELY AND EFFECTIVE AND
EFFICIENT PROCESS AND STILL HAVE
THE OVERSIGHT OF THE POLICY BY
OSP AND BY THE DAC.
THAT'S IN THE WORKS AND HOPE IT
WILL ALLOW WITHIN THE NEXT YEAR,
2023 AND I THINK RESEARCHERS
WILL BE PLEASED TO SEE THE MUCH
IMPROVED AUTOMATION WE CAN
AFFORD TO GIVING ACCESS TO
CONTROLLED ACCESS DATA.
THANK YOU SO MUCH.
>> THANK YOU FOR JOINING US AND
FEEL FREE TO POSE YOUR QUESTION
AND THERE'S BEEN GENOMIC DATA
POLICY ISSUES.
>> MY QUESTION STEMS FROM THE
GENOMIC DATA SHARING POLICY AND
I WAS ALSO WONDERING HOW WE
WOULD ADDRESS APPLICATIONS
SUBJECT TO GDPR AND NOT ABLE TO
SHARE THE DATA WITH THE NIH
REPOSITORY OF SOMETHING HOUSED
IN THE U.S.
>> I'M HAPPY TO TAKE THAT ONE.
THIS IS HONESTLY THE BEAUTY OF
THE DATA MANAGEMENT SHARING
POLICY IS IT GIVES FLEXIBILITY
TO INVESTIGATORS BUT DOES ASK
THEM TO PERSPECTIVELILY PLAN AND
IN THIS INSTANCE IF THERE'S A
LEGAL PROHIBITION FROM YOU
SHARING DATA THAT SOMETHING YOU
CAN DOCUMENT AND INCLUDE IN YOUR
PLAN.
IT'S ALSO GOOD TO KNOW WHAT THE
RESTRICTIONS ARE BEFORE YOU
START ENGAGING IN THE RESEARCH
PROJECT TO SEE IF IT MEETS YOUR
AIMS AND YOU WANT TO MOVE
FORWARD.
IT'S A RECALLING RESTRICTION AND
THAT CAN BE BUILT INTO YOUR DATA
MANAGEMENT SHARING PLAN.
>> I THINK YOU MIGHT HAVE
MENTIONED IN A RENT PRESENTATION
THERE'S A LOT OF INTEREST IN
WHAT THE NIH IS DOING IN THIS
SPACE AMONG NATIONAL GROUPS AND
HOPEFULLY WE CAN LOOK FORWARD TO
MAYBE MORE ALIGNMENT OR
HARMONIZATION IN THE FUTURE.
ANY COMMENTS ALONG THOSE LINES?
>> THE RESEARCH COMMUNITY HAS
KNOWN THERE'S BEEN EXTREME VALUE
IN GLOBAL COOPERATION AND
SHARING INFORMATION REGARDLESS
OF GEOGRAPHICAL LOCATION AND
THERE'S THE IMPORTANCE OF RAPID
DATA SHARING AND NOT WAITING IN
THE LAST MOMENT WAS OUT AND
SHARING INFORMATION IN REAL
TIME.
WE HAVE BEEN WORKING WITH GLOBAL
PARTNERS TALKING ABOUT OUR CLBL
POLICY FOR THOSE WHO DON'T HAVE
A POLICY FRAMEWORK.
WE'VE HELPED THEM STAB OR LEARN
FROM OUR GROWING PAINS TO GET TO
THE KEY COMPONENTS THAT MAY BE
VALUABLE TO HELP THEM CONSIDER
THEIR NEEDS AND PERMIT THIS
BROAD AND DEFAULT SHARING
PRACTICE.
>> YOU WERE SAYING WE WANT SOME
DEGREE OF FLEXIBILITY.
THEN IF EVERYBODY HAD THEIR OWN
LIBRARY YOU WOULDN'T BE ABLE TO
SEARCH ACROSS A SINGLE DATABASE.
HOW ARE YOU GUYS BALANCING ONE
SITE VERSUS THE NEED FOR
FLEXIBILITY.
HOW DO YOU BALANCE THAT?
>> FROM THE POLICY ORIGINATION
WE WERE INTERESTED IN HAVING A
HIGH BAR SO THE DATA IS FINDABLE
AND OPERABLE AND RE-SEUSS SREU.
WE WANTED THE DATA SHARED AND
USED AND HAVING THE PRINCIPLES
EMBEDDED IN A POLICY IS GREAT.
ON THE SAME TOKEN WE RECOGNIZE
IT'S A CULTURE SHIFT AND DIDN'T
WANT TO HAVE THE BAR SO HIGH NOT
EVERYBODY COULD COMPLY WITH THE
POLICY.
WE WANTED TO SHIFT THE TIDE
WITHOUT BEING SO STRINGENT AND
IT SET THE BENCHMARK AND OTHERS
CAN AUG MANY AS NEEDED.
THAT'S WHERE IN THE POLICY WE
BUILT IN THE FLEXIBILITY TO ALSO
CONSIDER EQUITY AND INCLUSION
AND INCLUSION IN THE POLICY
PRACTICES.
I'LL TURN TO MIKE AND SUSAN FOR
THEIR THOUGHTS.
>> FROM THE VIEW POINT OF
HOUSING AND SHARING DATA AND IN
MAKING THE POLICY WE DON'T WANT
TO MAKE IT SO HIGH IT WOULD BE
AN UNDUE BURDEN FOR DATA AND
WOULD LIKE TO ENCOURAGE
RESEARCHERS TO UTILIZE OPEN
ACCESS DATA SHARING REPOSITORIES
AS A FIRST CHOICE FOR SHARING
YOUR DATA AND THE SHARING THE
AND NIH HAS A COMPREHENSIVE LIST
AND REPOSITORY TO SHARE DATA AND
YOU CAN SHARE DATA THROUGH
ARTICLES THAT ARE IN PUB MED
CENTRAL IT'S ASSOCIATED DATA.
IT IS INDEXED IN AWS.
AND THE DATA FLAT TEXT AND THE
REUSABILITY IS AS GOOD AS
RESEARCHERS MAKE IT BUT THERE'S
THE OPTION IN ADDITION
RESEARCHERS CAN SHARE THEIR DATA
UP A NUMBER OF GENERALIST
REPOSITORY.
THE DATA OSF AND WE HAVE A
PROGRAM THAT KNIT THE
REPOSITORIES INTO AN ECO SYSTEM
AND LOOKING TO MAKE IT SHAREABLE
TO IMPROVE DISCOVERABILITY AND
CERTAIN AND REUSE AND PROVIDE
ADDITIONAL TRAININGS FOR
RESEARCHERS HOW TO MAKE THEY'RE
DATA FAIR.
I HOPE THE CAPABILITIES THROUGH
THE CAN BE REPLICATED IN THE
INSTITUTIONAL LIBRARY
REPOSITORIES AT A LATER DATE IF
DESIRED.
I THINK THERE'S WAYS WE CAN
START TO CREATE A DATA ECO
SYSTEM BUT WE'RE WORKING AT THIS
AND HOPING THEY LOOK TO MAKE
THEY'RE DATA FINDABLE AND
SHAREABLE AND IN THE PROGRESS
REPORT LOCATE US KNOW WHERE THE
DATA ARE IS ANOTHER WAY TO HELP
WITH STRONGER DATA SHARING
CAPABILITIES.
YOU CAN HAVE HUNDREDS OF PEOPLE
AND THE RESULTS FOR HOW THEY'RE
EXPERIMENT WENT FOR THAT GENE.
THAT WAS THE HIGHEST EXPRESSION
AND WE'RE NEVER GOING GET THAT
AS A COMMUNITY.
THAT'S THE TRADE-OFF.
YOU HAVE PRESENTED IN A NUMBER
OF MEETINGS LIKE THIS AND
SIMILAR ONES.
WHAT QUESTIONS ARE YOU HEARING
YOU HAVEN'T YET PERCEIVED DURING
THIS DISCUSSION BECAUSE I'M SURE
THEY'LL BE OF GENERAL INTEREST.
ANYTHING YOU WANTS TO SHARE BACK
TO US?
>> ONE QUESTION I GOT ASKED WAS
ABOUT QUALITATIVE DATA AND
THERE'S A NUMBER OF RESEARCHERS
USING QUALITATIVE DATA.
ONE DOES THE POLICY APPLY AND
HOW DO WE ENSURE CONFIDENTIALITY
AND HAVE ASSESSMENTS LOOKING AT
WHETHER OR NOT SFMZ --
AND HOW DOES THE CONFIDENTIALITY
PRESERVE AND SO FORTH.
IT'S INTERESTING IN FOLLOW-UP TO
THAT.
WE'RE GOING TO POST AN FAQ OR
TWO ABOUT QUALITATIVE DATA AND
INDICATE IT'S SUBJECT TO THE
POLICY AND THAT WE DO EXPECT TO
SEE PLANS.
WE ALSO FOUND A NUMBER OF
INTERESTING RESOURCES OUT THERE
ABOUT SHARING QUALITATIVE DATA.
HOW DO YOU DO IT?
HOW DO YOU DO IT IN A WAY WHICH
IS EFFECTIVE AND FAIR AS WE'RE
USING IT BUT ALSO APPROPRIATELY
PROTECTS THE CONFIDENTIALITY AND
PRIVACY OF INDIVIDUALS?
THAT'S ONE QUESTION THAT I SAW
IN A MEETING WAS INTERESTING AND
THERE'S RESOURCES OUT THERE THAT
APPEAR TO BE QUITE GOOD AND A
NUMBER OF PEOPLE WEREN'T AWARE
OF.
A HARD QUESTION I GET ASKED
OFTEN BECAUSE ARTIFICIAL
INTELLIGENCE IS A DRIVER OF DATA
IS HOW TO IDENTIFIED AND ADDRESS
HIDDEN BIAS IN DATA.
WE'RE STARTING TO TACKLE THE
CREATION OF DATA AND LOOKING AT
ETHICAL FRAMEWORKS FOR BIAS.
BOTH THROUGH NOSI TO HELP
RESEARCHERS DEVELOP THE ETHICAL
FRAME WORKS AND THE A.I. AND
CREATING DATA FRAME WORKS FOR
ASSESSING ETHICAL BIAS.
ALSO THERE'S TWO NEW PROGRAMS
THE AIM AHEAD PROGRAM WHICH IS
DESIGNED TO DEVELOP ALGORITHMS
TO ADDRESS ETHICS AND BIAS WITH
RESPECT TO HEALTH INEQUITIES AND
FOCUSSING ON CREATING GOLD
STANDARD DATA SETS THAT INDEED
ADDRESS HIDDEN BIAS.
HE'S ARE HARD QUESTIONS.
AND THIS IS STILL AN ONGOING
EFFORT.
THIS IS A TOUGH QUESTION WE ARE
STARTING TO ADDRESS.
>> THANK YOU, DO YOU WANT TO ADD
TO THOSE AS THINGS YEAR HEARING
A LOT AND SPEAK TO.
>> ONE THING WE HEAR IS HOW DOES
IT FIT IN WITH OTHER POLICIES
AROUND DATA SHARING AND HOW ARE
WE WORKING TO HAVE CONSISTENCY.
THIS IS PARTICULARLY GERMANE FOR
THE GENOMIC DATA SHARING POLICY
WHICH REQUIRES A PLAN FOR
SHARING DATA.
WE'RE WORKING TO HARMONIZE THOSE
POLICIES AND THE LAST THING WE
WANT IS INVESTIGATORS TO SUBMIT
20 DIFFERENT PLANS DEPENDING ON
THE THINGS THEY'RE DOING OR WHO
THEY'RE COMPLYING WITH.
WE'RE LOOKING AT OUR GENOMIC
SHARING POLICY AND PUT OUT A
NOTICE FOR COMMENT AND THINKING
HOW TO HARMONIZE A PLAN
SUBMISSION AND OUR OER TEAM IS
WORKING HARD ON MAKING THAT
HAPPEN AND LOOKING ACROSS AGENCY
TO OTHER POLICIES TO MAKE SURE
THERE WEREN'T CONFLICTING
REQUIREMENTS FOR INVESTIGATORS
BUT AGAIN THINKING HOW TO
PRESERVE THE FLEXIBILITY AND
RECOGNIZING THE POLICY IS A
BASELINE BAR AND OTHER
INSTITUTES MAY HAVE DATABASES TO
CREATE A CONSISTENCY SO PEOPLE
DON'T FEEL THIGH HAVE MULTIPLE
PEOPLE TO RESPOND TO.
>> WE'RE EXCITED ABOUT GOOD DATA
UPLOADED BUT WHAT HAPPENS WITH
BAD DATA?
IS IT A NECESSARY FIELD FOR ALL
UPLOADS?
THAT SEEMS IMPORTANT.
>> WE FOUND DURING COVID HAVING
BAD DATA WAS MORE IMPORTANT IN
HAVING COURSE DIRECTION.
SOME IS AKIN TO SCIENTIFIC
PUBLICATION AND HAVING
INFORMATION WHERE OTHERS CAN
UNDERSTAND IT'S A BAD DATA SET
IN ADVANCE.
>> OVER TIME THIS WILL IMPROVE
THE QUALITY OR IMPROVE THE
QUALITY OF ANNOTATION OF DATA
BECAUSE SCIENTISTS KNOWING THAT
SCIENCE IS BEING MADE AVAILABLE
MORE WIDELY MAY HAVE AN
INCENTIVE TO MAKE SURE THEY HAVE
IT THEY HAVE IT IT IN GOOD SHAPE
AND WELL CHARACTERIZED.
FOR EXAMPLE THERE'S A CODE IT'S
WELL ANNOTATED AND EXPLAINED AND
WHAT'S INTERESTING TO ME, I FOR
EXAMPLE ONE THING I SOMETIMES DO
IS READ ECONOMIC ARTICLES AND
THEY'VE BEEN SHARING FOR A LONG
TIME AND SOMETIMES THEY ANALYZE
DATA SOMEONE ELSE GENERATED AND
COME UP WITH A DIFFERENT RESULT.
THIS CAN LEAD TO AN INTERESTING
BACK AND FORTH ABOUT NOT ONLY
THE ANALYTICAL APPROACH AND
INTERPRETATION BUT THE DATA
QUALITY AND MAY SAY THIS
PARTICULAR FIELD IS A HIGHLY
UNRELIABLE FIELD FOR X, Y, Z
REASONS.
IT'S A TWO-EDGED SWORD BUT IT'S
POSSIBLE IN THE COURSE OF MAKING
DATA AVAILABLE THAT THIS MAY
ACTUALLY HELP TO RAISE THE BAR
AND IMPROVE THE QUALITY OF DATA
ACROSS THE WAY.
NOW, ANOTHER ABSOLUTE EXTREME
WHICH SOMETHING WE HOPE NEVER
HAPPENS OR RARELY IS WHERE ONE
HAS OUTRIGHT FRAUDULENT DATA.
WE'VE HAD OF COURSE CASES OF
SCIENTIFIC FRAUD OVER THE
DECADES WHERE IN SOME CASES IT
TOOK A VERY LONG TIME FOR THAT
FRAUD TO BE UNCOVERED AND HAD
OTHER CASES FOR EXAMPLE THERE
WAS A SURVEY ARTICLE THAT
APPEARED IN SCIENCE ABOUT
PEOPLE'S ATTITUDES ON CERTAIN
SOCIOLOGICAL ISSUES WHERE WITHIN
A MATTER OF DAYS THE ARTICLE GOT
RETR
RETRACTED.
THAT HAPPENED BECAUSE THE
JOURNAL REQUIRED THE SHARING OF
DATA THERE WERE ENTERPRISING
RESEARCHERS ELSEWHERE WHO LOOKED
AT THE DATA AND FAIRLY QUICKLY
DETERMINED THERE WAS SERIOUS
PROBLEMS THAT SET THE DOMINOS
GOING AND THERE WAS FRAUD THAT
COULD BE UNCOVERED WITHIN A
SHORT PERIOD OF TIME.
THAT IS NOT THE REASON WHY WE'RE
IMPLEMENTING THIS POLICY BUT
NONETHELESS, THAT'S AN EXTREME
EXAMPLE THAT ILLUSTRATES AN
IMPORTANT POINT WHICH IS THAT BY
MAKING THE DATA AVAILABLE IT
MIGHT MAKE IT EASIER FOR THE
SCIENTIFIC COMMUNITY TO IDENTIFY
PROBLEMS FASTER RATHER THAN
SLOWER.
>> INTERESTING POINTS.
ALSO, MAYBE LONG THOSE LINES,
WITH INVESTIGATORS INCREASINGLY
RECOGNIZING THEY MUST SHARE THAT
DATA, HOPEFULLY THAT RAISES THE
BAR IN TERMS OF THE QUALITY OF
DATA THEY'RE GOING TO GO TO
PUBLICATIONS.
THAT'S AN ENCOURAGING OUTCOME WE
CAN ASPIRE TO ACHIEVE.
>> I WAS WONDERING IF YOU WOULD
TALK A LITTLE BIT ABOUT THE
RELATIONSHIP BETWEEN THE NEW
POLICY AND FOR CLINICAL TRIALS
DATA AND THE RELATIONSHIP WITH
CLINICALTRIALS.gov REQUIREMENTS.
SO THE POLICY ON
CLINICALTRIALS.gov INDICATED ALL
NIH-FUNDED CLINICAL TRIALS MUST
GO THROUGH RENL ADMINISTRATION
AND REPORTING.
THERE HAS TO BE REGISTRATION
WITHIN 21 DAYS OF WHEN THE FIRST
PATIENT IS ENROLLED AND THAT'S
REPORTING THE AGGREGATE RESULTS
ON CLINICALTRIALS.gov AND THAT
HAS TO OCCURRED WITHIN ONE YEAR
OF COMPLETION OF THE PRIMARY END
POINT.
THAT'S REPORTING AGGREGATE
RESULT AND CERTAIN OUTCOMES AND
THIS IS THE PRIMARY OUTCOME IN
THE MAIN EFFECT SIZE.
THESE ARE NOT INDIVIDUAL LEVEL
DATA BUT ON AN AGGREGATE LEVEL
WHAT THE MAIN FINDINGS ARE.
THIS IS A BIT DIFFERENT BECAUSE
WHAT WE'RE TALKING ABOUT HERE
WOULD BE REPORTING THE
INDIVIDUAL LEVEL DATA THAT
GENERATED THOSE AGGREGATE
RESULTS.
ONE EXAMPLE OF THAT IS YOU CAN
COULD SAY THE ORIGINAL POLICY
SAID THE MAIN RESULTS LIKE WERE
REPORTED IN THE JOURNAL ARTICLE
AND CLINICALTRIALS.gov HAVE TO
BE FORWARDED BUT THE NEXT STEP
IS SAYING YOU NEED
INDIVIDUAL-LEVEL DATA ON THOSE
10,000 PATIENTS THAT GENERATED
THE PLOTS AND FIGURES AND THE
TABLES IN THE MAIN PAPER.
I HOPE THAT MAKES SENSE.
DOES THAT MAKE SENSE?
>> FOR P.I.s OF
CLINICALTRIALS.gov THERE'S TWO
REQUIREMENTS ONE POST INNING
CLINICALTRIALS.gov AND AT THE
END OF THE STUDY SHARING THE
DATA IN WHATEVER DATA TRY OR
REPOSITORY.
IS THERE A PLAN TO CONNECT THE
TWO?
THERE'S PLACES WHERE PEOPLE HAVE
DATA ACCORDING TO SET
PARAMETERS.
>> WE HAVE BEEN TALKING ABOUT
CONNECTING THROUGH AN API
APPLICATION PROGRAM INTERFACE
CLINICALTRIALS.gov AND GB GAP.
FOR STUDIES TO REGISTER IN
CLINICALTRIALS.gov HAVING THE
INFORMATION FLOW INTO DB GAP AND
IT'S OFTEN THE POINT OF
REFERENCE FOR MANY REPOSITORIIE
MIKE TALKED ABOUT FOR NHLBI AND
DB GAP IS A POINT OF REFERENCE
FOR THOSE CLINICAL TRIAL.
I THINK THERE'LL BE A CONNECTION
POINT BETWEEN THE TWO SERVICES.
>> WE HAVE A CONNECTION BETWEEN
E.R.A. AND CAN
CLINICALTRIALS.gov.
MANY FIELDS IN THE GRANT
APPLICATION MATCH UP WITH THE
FIELD IN CLINICALTRIALS.gov.
WE'RE HOPING IT WILL HELP MAKE
IT EASIER AS WELL AS AFFORDABLE
>> HOW WILL YOU EVALUATE THIS IS
ACHIEVING WHAT YOU WANT TO
ACHIEVE.
PEOPLE WILL BE DEPOSITING DATA
BUT IS THERE PLANS TO MEASURE
USAGE OR WHETHER THE DATA BEING
SHARED ARE CITED?
DO YOU HAVE BASELINE OR OUTPUTS
YOU'LL BE EVALUATING OVER TIME?
>> ABSOLUTELY.
THIS IS AN IMPORTANT COMPONENT
OF THE POLICY.
AT SOME POINT MAKING DATA
ACCESSIBLE AND FINDABLE IS A
PUBLIC GOOD WHICH IS DIFFERENT
THAN BEING USED TO ADVANCE
SCIENCE.
THERE'S MULTIPLE METRICS BY
WHICH WE'LL WANT TO UNDERSTAND
HOW IS IT ADVANCING NEW RESEARCH
QUESTIONS ARE PEOPLE REUSING THE
DATA EVEN IF ONLY A FRACTION IS
IT CAUSING OTHER ACHIEVEMENTS?
WE'LL SEE IF THE POLICY NEEDS TO
EVOLVE.
THIS IS SOMETHING OUR POLICY
OFFICE DOES A BIT IN MATERIALS
OF EVERY FIVE TO TEN YEARS YOU
NEED IT MAKE SURE WE HIT THE
MARK AND OUR POLICIES KEEP PACE
AND ADVANCE.
IT WILL BE ON THE COMPONENT WE
ARE TRACKING.
>> I'M WONDERING IF I CAN CALL
ON BOB CARTER IF HE'S AVAILABLE
AT THE MOMENT.
>> IT OCCURS TO ME SINCE WE
HIGHLIGHTED AMP EARLIER IN THE
MEETING TODAY WE'RE TALKING
ABOUT HOW AND WHERE TO SHARE
DATA.
THOSE ARE IMPORTANT ISSUES WE'VE
BEEN THINK IN THE CONCEPT OF THE
ACCELERATED EFFORT AND THE
SYSTEM OF BIOLOGY CONCEPT
SUSAN'S BEEN HELPING WITH.
DO YOU WANT TO SAY AA FEW -- A
FEW WORDS HOW WE LOOK AT THE
ISSUES IN AMP AND STRIKING A
BALANCE BETWEEN GREATEST
VISIBILITY AND ACCESSIBILITY
VERSUS FUNCTIONALITY, ETCETERA.
FOR AMP LUPUS AND NOW AMP AIM
THE IDEA OF COMPARING OMICS
ACROSS DISEASES WAS A CORE PART
OF THE CONCEPT LEARNING NOT JUST
ABOUT A GIVEN DISEASE BUT THE
PATHWAYS IN COMMON AND PATHWAYS
TO SPECIFIC DISEASES.
THE AMP AIM IS GOING TO JOIN THE
ALZHEIMER'S DISEASE AMP PROJECT
IN THEIR KNOWLEDGE PORTAL.
THERE'S A KNOWLEDGE PORTAL TO
ALLOW TOOLS TO QUERY THE DATA
SET.
THEN BIGGER QUESTIONS COME UP
AND BACK TO LUIS' POINT ABOUT
DATA SCATTERED AROUND.
WE STARTED THINKING ABOUT DATA
SETS OUTSIDE OF AMP COULD
PROVIDE A RICHER DATA SET THAN
IN ISOLATION.
WE HAD CONVERSATIONS PEOPLE
FUNDED THROUGH NIAMS AND OTHER
NEEDS AND AGREED THEIR DATA SET
THAT ARE AMP LIKE WILL ALSO GO
IN THE KNOWLEDGE PORTAL.
THAT EXPANDS THE NUMBER OF
DISEASES PRESENT IN THE
KNOWLEDGE PORTAL SO THE ABILITY
OF THE DISEASES ARE DIFFERENT.
WE HAD PSORIASIS A SKIN DISEASE
AND LUPUS AND SKIN DERMAL
DISEASE AS VITILIGO AND DATA
PLACES ARE IN DIFFERENT PLACES
YOU WOULD THINK IT'S A
NO-BRAINER THEY'RE
INTRAOPERABLE.
DO YOU GET PERMISSION FROM
INVESTIGATORS TO SHARE THE DATA
AND THEY MAY NOT HAVE AGREED TO
SHARE ACROSS AMP.
IT'S A DIFFERENT QUESTION.
AND IT DOES ALLOW SHARING WITH
THE ALZHEIMER'S AND BELIEVE IT
OR NOT THERE'S SIMILARITIES
BETWEEN LUPUS, R.A. AND
ALZHEIMER'S WHICH IS
FASCINATING.
THERE'S AN EFFORT SUSAN'S
LEADING TO GET THE DIFFERENT
COMMON FUND PROJECTS TO TALK TO
EACH OTHER.
AND WE DON'T THINK ANY MORE
ABOUT TRYING TO GET EVERYTHING
IN ONE PLACE BUT DO TRY TO THINK
ABOUT A FEDERATED ECO SYSTEM.
AND HOW TO CREATE THE SYSTEMS
AND HARMONIZE THE DATA TO DO THE
COMPARISONS IS I THINK THE
FUTURE OF SCIENCE IF I MAY BE
BEFORE THERE.
>> YOU'RE RIGHT.
THIS IS SOMETHING WE'VE BEEN
SLOWLY NIBBLING AT TWO AND A
HALF YEARS BUT WE'RE MAKING
PROGRESS AND READY TO GO BIGGER
AND BRIGHTER AND ACROSS OUR NIH
PLATFORMS INCLUDING THE AMP
PORTAL AND THE BIO DATA CATALYST
AND THE G TEX DATA AND GB GAP
AND OTHER DATA PLATFORM AND A
WAY TO CONNECT ACROSS OUR
DIFFERENT PLATFORMS.
WE STARTED WITH ALLOWING
RESEARCH
RESEARCHERS TO SIGN ON ONCE AND
HAVE ACCESS ACROSS OUR FEDERATED
SYSTEM AND IT'S A MAJOR EFFORT
AND LOGGING CREDENTIALS AND LOG
IN.gov AND HOPEFULLY SOON
UNIVERSITY CREDENTIALING
SYSTEMS.
WE'RE HOPING TO PULL AND
AGGREGATE DATA ACROSS OUR
PLATFORMS AS ANOTHER EFFORT AND
HARMONIZE AND PROVIDE THE
ANALYTIC TOOLS FOR ANALYSIS THIS
I BELIEVE IS THE WAY OF THE
FUTURE AND ALLOW INSTITUTES TO
FUND THE DATA REPOSITORIES FOR
RESEARCH EFFORTS AND ALLOW
RESEARCHERS TO HAVE ACCESS
ACROSS NIH TO THE PLATFORMS EACH
INSTITUTE SUPPORTS.
WE HAVE RESOURCES SO IT'S BEEN A
GREAT EFFORT AND I THINK YOU'LL
SEE MORE FROM COMMON FUND AND
OUR OFFICE AND ACROSS THE
DIFFERENT PROGRAMS SUCH AS AMP
AND THE DIFFERENT INSTITUTES.
AND ANYTHING ABOUT THE PRACTICAL
CHALLENGES THAT MAYBE WEREN'T
EXPECTED TO WORK THROUGH.
NICK ELSE YOU WANT TO ADD?
>> I THINK BOB BROUGHT UP AN
INTERESTING POINT WHERE
INVESTIGATORS ARE READY TO SHARE
THEIR DATA.
IT RELATES TO THE COMPLEXITY OF
THE DATA SETS AND MAKES THE DATA
ANALYSIS PROW LONGED AND WE HAVE
A RELATIVE EXPLOSION, IF YOU
WILL, OF DATA SETS AND THE
SMALLER NUMBER OF INVESTIGATORS
AND SCIENTISTS PREPARED AND THE
EXPERIENCE TO ANALYZE THE DATA
SETS WITH COMPLEXITIES.
THEY HAVE TRIED SEVERAL
APPROACHES AND THAT BECOMES AN
ISSUE WHEN IT COMES TO SHARING
WITH OTHER INVESTIGATORS WHO MAY
BE INTERESTED IN THE DATA SET.
NOT WHETHER OR NOT INVESTIGATORS
WANT TO SHARE I THINK THE
WILLNESS IS THERE.
IT'S A MATTER OF ANALYZING THE
DATA TO THE POINT IN WHICH THEY
CAN REACH SOME CONCLUSIONS AND
THEN BE ABLE TO FORMULATE THEIR
CONCLUSIONS AND PUBLICATIONS AND
SHARE WITH THEM.
THE TIMING OF SHARING IN DATA
BECOMES AN ISSUE WHEN YOU HAVE A
WORKFORCE STILL IN THE SPACE.
THAT'S ONE ISSUE USING THE
SYSTEM OF ANNOTATION AND QUALITY
CONTROL AND DATA INTEGRATION AT
THE LEVEL OF THE KNOWLEDGE
PORTAL SEEMS TO BE WORKING FOR
THE AMP PROJECT IN PART BECAUSE
INVESTIGATORS MANY OF THE
INVESTIGATORS WHO ARE IN THE
BIOLOGY AREA NOT NECESSARILY IN
THE SYSTEMS BIOLOGY SIDE FOR
COMPUTER SCIENCE SIDE OF THE
HOUSE DO WANT TO HAVE TOOLS TO
LOOK AT THE DATA IN THE
KNOWLEDGE PORTAL.
THAT'S IMPORTANT TO THEM.
THEY DON'T HAVE THE EXPERTISE SO
FOR US GOING TO A KNOWLEDGE
PORTAL BECAME A RELEVANT ASPECT
IN THE DECISION.
SUDDENLY THERE'S ADDITIONAL
TOOLS WITHIN THE KNOWLEDGE
PORTAL THAT IS BEING USED FOR
ALZHEIMER'S THAT WE HOPE WILL BE
APPLICABLE AND THERE'S AN ISSUE
OF COST EFFECTIVENESS FOR THE
AMP PROJECTS THERE AS WELL.
WE'RE VERY EXCITED AND I DON'T
KNOW IF THERE IS ANY OTHER
SPECIFIC QUESTIONS I'LL BE HAPPY
TO ANSWER THEM.
>> THANK YOU FOR SPEAKING TO
THAT AND GETTING TO THE ASPECT
WHICH IS IMPORTANT AND RELEVANT
TO SO MANY.
LUIS, YOU HAD YOUR HAND UP.
>> IT CANNOT BE UNDER STATED THE
LACK OF EXPERTISE IN THE
COMMUNITY IS ASTOUNDING.
I WANT WANT TO ECHO THE
BEAUTIFUL THOUGHT THE DATA
SHARING TEAM SHOULD THINK OF
EMBEDDING IN THE DATABASES
ANALYSIS TOOLS AND I WANT TO
ECHO WHAT SUSANA SAID BECAUSE
IT'S PROFOUNDLY IMPORTANT.
>> THANK YOU.
MARY AND THEN DALE.
>> A PIE IN THE SKY COMMENT
ABOUT PHASE TWO AND THREE OF
THIS APPROACH IS WHETHER HAVE
THERE BEEN DISCUSSIONS WITH THE
FDA IN THINKING OF REQUIRING
PRIVATELY SPONSORED CLINICAL
TRIALS TO HAVE DATA REPOSITORIES
AS WELL AND THERE HAS BEEN A BIG
PUSH FOR THAT AND WAS A NEW
ENGLAND JOURNAL ARTICLE ABOUT
THE IMPORTANCE OF IT BUT IF THE
TWO COULD COME TOGETHER, THAT
WOULD BE INCREDIBLY POWERFUL.
I KNOW THAT'S OUT OF THE REACH
OF THE NIH BUT IF THERE ARE
GROUPS WORKING ON THAT, THAT
WOULD BE REALLY GOOD.
ANY COMMENTS?
>> WE'RE ALWAYS LOOKING FOR WAYS
TO WORK WITH THE GROUPS THINKING
HOW TO MAXIMIZE DATA SHARING AND
REPOSITORIES AND ACCELERATE THE
PIPELINE OF NIH DISCOVERY AND
THE NIH DISCOVERY INTO THE FDA
APPROVAL PROCESS AND TO THE
REIMBURSEMENT ISSUE.
THAT BEAUTIFUL PIPELINE.
IT'S A CONVERSATION WE'RE ALWAYS
HAVING AND THINKING INTO THE
IMPORTANCE OF PROTECTING THE
INNOVATION AND THE CATALYZING
PROPRIETARY INFORMATION THAT
MAKES THAT PIPELINE ROBUST.
THERE'S CHALLENGES IN THOSE
FACTORS.
THERE'S BEEN REQUIREMENTS TO
SHARE AND IN OTHER FIELD IT'S
BECOMING MORE REAL AND THE
CLINICAL JOURNALS WHILE THEY MAY
NOT BE REQUIRING DATA SHARING
ARE PUTTING IN TO THE FULL ARM
AND FOR EXAMPLE ASKING THE
INVESTIGATORS TO BE QUITE
EXPLICIT IN WHAT THEIR DATA
SHARING PLANS WILL BE.
ONE COULD IMAGINE A FUNDING
AGENCY AND REGULATORY AGENCIES
AND JOURNALS ALL SINGING THE
SAME TUNE WILL HELP SHAPE THE
CULTURE.
>> I WANTED TO GIVE A SHOUT OUT
TO SUSAN AND HER OFFICE BECAUSE
SOME OF THEIR INVESTIGATORS HAVE
ADDRESSED TOOLS AND NOT BEING
TRAINED IN DATA ANALYTICS AND
THERE'S BEEN SUPPLESS -- BEEN
SUPPLEMENTS FOR EXISTING GRANTS
AND MORE THAN BEFORE.
THESE ARE REAL OPPORTUNITIES AND
WE NEED TO MAKE THEM AWARE OF
THE OPPORTUNITIES TO TAKE
ADVANTAGE OF THESE AND DEVELOP
TOOLS WITH COLLEAGUES WHO HAVE
THAT EXPERTISE OR FIGURE OUT HOW
TO BEST ADDRESS THEIR ISSUES OR
QUESTIONS.
>> THANK YOU, WE'RE GOING
CONTINUE TO SUPPORT THE
COLLABORATION BETWEEN BIOMEDICAL
TOOLS AND THOSE SUPPORTING
RESEARCH AND WE HEARD FROM
COUNCILS THE NEED FOR INCREASED
TRAINING.
I WANT TO NOTE WE ARE DEVELOPING
OUR STRATEGIC PLAN FOR DATA
SCIENCE THAT WILL SPAN 2023 TO
2028.
THERE'LL BE A LARGE SECTION ON
TRAINING.
I THINK YOU'LL SEE MORE TRAINING
ACTIVITIES THAT DO PARTNER
TRAINING CAPABILITIES WITH OUR
DATA REPOSITORIES AND PLATFORMS.
IT'S AN UNMET NEED.
THANK YOU FOR BRINGING THIS UP.
IT'S VERY IMPORTANT AND IN
PARTICULAR TO REALLY ADDRESS
TRAINING RESOURCES FOR UNDER
REPRESENTED POPULATIONS OR THOSE
NOT FAMILIAR WITH DATA SCIENCE.
THERE'S ABSOLUTELY A LARGE
DIVIDE BETWEEN RESEARCHERS WHO
ARE QUITE CAPABLE IN DATA
SCIENCE AND TAKING ADVANTAGE OF
LARGE SCALE DATA AND OTHERS WHO
ARE NOT.
I THINK IN THIS DAY AND AGE WE
CAN DO A LOT TO ENHANCE THE
TRAINING.
YOU'LL SEE MORE ACTIVITIES IN
THIS AREA AND THANK YOU AGAIN.
THIS IS AN IMPORTANT ACTIVITY
WE'RE HAPPY TO SUPPORT AND
PARTNER WITH THE INSTITUTES ON
THE ACTIVITY.
>> GREAT, THANK YOU SO MUCH THE
THREE OF YOU FOR JOINING US
TODAY TO HAVE A REALLY IMPORTANT
AND FASCINATING POLICIES AND
PHASES TWO, THREE AND FOUR AND
BEYOND.
I APPRECIATE THAT.
WE'RE GOING TO NOW TURN TO
ANOTHER DATA RELATED TOPIC AND
SUSAN AND MIKE FEEL FREE TO JUMP
OFF NOW OR LISTEN TO THE NEXT
COUPLE PRESENTATIONS.
THANK YOU.
WE'RE GOING TO HEAR FROM SUSANA.
SHE PRESENTED SEVERAL TIMES
BEFORE IN RECENT YEARS AND
ACTIVE IN THE CONVERSATION WE
WERE JUST HAVING AND OUR
ASSOCIATE DIRECTOR FOR STRATEGIC
INITIATIVES.
SHE'LL PROVIDE AN UPDATE OF A
LANDSCAPE ANALYSIS OF CURRENT
RESEARCH THAT INVOLVES DATA
SCIENCE.
AND AS YOU'LL SEE SHE'LL HAVE
COMPARISONS TO NIH MORE
GENERALLY AND THEN WE'LL MOVE ON
TO ANOTHER DATA-RELATED
PRESENTATION.
>> THANK YOU.
I'M EXCITED TO MAKE THE
PRESENCE.
WE HEARD ABOUT THE NEW POLICY
THE NIH HAS DEVELOPED AND WILL
BE IMPLEMENTED STARTING IN
JANUARY 2023.
YOU'LL BE HEARING MORE WHAT THE
NIMS AND HOW THE NIAMS IS
HELPING TO IMPLEMENT POLICIES AS
WE RECEIVE MORE GUIDANCE AND
TRAINING FROM CENTRAL.
YOU'LL HEAR OPERATIONALLY HOW
THE INSTITUTE IS GETTING READY
TO WORK WITH THE INTRAMURAL
INVESTIGATORS TO PUT IN PLACE
SYSTEMS AND POLICIES AND
INFRASTRUCTURE THAT ARE REQUIRED
TO COMPLY WITH THE POLICY.
ALL THESE EFFORTS ARE GEARED
TOWARDS ONE GOAL WHICH IS TO
MAKE THE DATA AVAILABLE TO
ADVANCE RESEARCH.
SOME IS ALREADY HAPPENING AND
BEING FUNDED BY THE NIH AND BY
THE NIAMS.
THE PURPOSE IS TO PROVIDE AN
OVERVIEW OF WHAT THE NIAMS
INVESTMENT IS CURRENTLY ON DATA
SCIENCE AS IT RELATES TO THE
RESEARCH ACTIVITIES IN THE
COMMUNITY BOTH INTRAMURALLY AND
EXTRAMURAL.
WHAT IT IS AND HOW WE CAN
REFLECT BACK TO YOU WHAT WE ARE
DOING IN DATA SCIENCE RESEARCH.
AND WHY ARE WE LOOKING AT THIS?
I SHOULD SAY THIS ANALYSES THIS
LANDSC
LANDSCAPE ANALYSES I'M
PRESENTING IT BUT IT'S MY
COLLEAGUE WHO DID A LOT OF THE
WORK AND MOVED TO THE NATIONAL
INSTITUTE ON AGES AND SYSTEMS
BIOLOGY FOR THE AGING INSTITUTE.
SHE PRODUCED A LOT OF THE DATA
I'M SHARING TODAY.
SO WHY ARE WE LOOKING AT THIS?
THE INVESTIGATORS THE COMMUNITY
IS PRODUCING A LOT OF VERY
COMPLEX DATA SETS COMING FROM
OMIC STUDIES, CLINICAL STUDIES
AND THE AVAILABILITY OF THE DATA
AND INCREASE DATA STORAGE AND
THE NEW TOOLS TO ANALYZE THOSE
COMPLEX DATA SETS IS
ACCELERATING THE PACE OF
RESEARCH.
MACHINE LEARNING AND ARTIFICIAL
INTELLIGENCE AND DATA SCIENCE
ARE CHANGING HOW BIOMEDICAL
RESEARCH IS BEING CONDUCTED.
WE WANTED TO SEE HOW OUR
INSTITUTE IS FUNDING THE AREA OF
RESEARCH AND I'M GOING TO
PRESENT THE FIRST PHASE OF THE
LANDSCAPE ANALYSIS.
IT'S A DESCRIPTIVE COMPONENT OF
THE ANALYSIS WHERE WE LOOKED AT
WHAT WE ARE FUNDING AND WE
WANTED TO ADDRESS BASICALLY
THREE QUESTIONS.
WHAT IS OUR INVESTMENT IN TERMS
OF TYPES OF AWARDS AND FUNDING
PROVIDED.
ARE THE PROJECTS BEING FUNDED
FACILITATING SHARING?
ARE THE RESOURCES AND KNOWLEDGE
BEING CREATED SHARED WITH OTHERS
IN THE COMMUNITY.
AND HOW IS DATA SCIENCE
REPRESENTED.
WE MADE A DECISION EARLY ON TO
FOCUS ON FUNDING AND DATA
SCIENCE AND RELATED ENDEAVORS
OVER THE LAST FIVE FISCAL YEARS
BEGINNING IN 2017 AND WITH DATA
WE HAVE ON FISCAL YEAR 2020 AND
DECIDED TO FOCUS ON ACTIVE
AWARDS AND WHY WE MADE THE
DECISION.
ACTIVE AWARDS MEANING COMPETING
AWARDS AND NON-COMPETING AWARDS.
WE FINALLY DECIDED TO LOOK AT
THREE CATEGORIES THAT ARE
ESTABLISHED BY THE NIH SYSTEM
RESEARCH CONDITION AND DISEASE
CATEGORIZATION SYSTEM.
THERE'S A COMPUTERIZED REPORTING
SYSTEM THE NIH USE TO REPORT
WHAT THE NIH IS FUNDING IN ANY
GIVEN CATEGORY TO THE PUBLIC AND
CONGRESS.
THERE'S 280 DIFFERENT
CATEGORIES.
FOR EXAMPLE, A PROJECT ON THE
GENETICS AND EPIGENETICS OF
OSTEOARTHRITIS CAN BE CHARACTER
CATEGORIZED AND THE RESEARCH
CATEGORY OF OSTEOARTHRITIS AND
WHEN COUNTING ANALYSES LIKE THE
ONE I'LL PRESENT RIGHT NOW, WE
MADE SURE TO COUNT THE DOLLARS
ONLY ONCE.
THERE'S NO DOUBLE COUNTING OF
RESEARCH DOLLARS IN WHAT I'M
ABOUT TO PRESENT TODAY THOUGH
SAME PROJECT MAY BE CATEGORIZED
AND MAY BE INCLUDED IN THE
DIFFERENT RESEARCH CATEGORIES.
THIS IS A PUBLIC DATA SET.
IT WAS IMPORTANT TO US FROM THE
POINT OF VIEW TO USE RELIABLE
OPEN DATA SETS AVAILABLE OUT
THERE AND WE USED THE TOOLS OF
REPORTER TO ANALYZE THE DATA.
WE LOOKED AT ACTIVE YEARS AND
WE CHOSE THREE CATEGORIES THAT
ARE RELEVANT.
A LONG STANDING CATEGORY CALLED
NETWORKING AND INFORMATION
TECHNOLOGY R&D.
THIS IS USED ACROSS THE FEDERAL
GOVERNMENT GOVERNMENT.
THERE'S A COORDINATING COMMITTEE
WHICH IS THE NIPRD COMMITTEE AND
THAT IS MANAGED BY THE WHITE
HOUSE AND A REPRESENT TO THAT
DR. GREGURICK.
IS A LONG STANDING CATEGORY.
THERE'S TWO NEWER CATEGORIES THE
NIH STARTED REPORTING ON
BEGINNING IN 2019.
MACHINE LEARNING AND ARTIFICIAL
INTELLIGENCE AND DATA SCIENCE.
THE CONCEPTS UNDER THESE
CATEGORIES SOME DEGREE OF
OVERLAP BUT FOR THE PURPOSES OF
ANALYSIS WE MADE SURE THAT THERE
IS NO DOUBLE-DOUBLE.
WHAT IS THE NIH DOING.
IF YOU HAVE ANY QUESTIONS FEEL
FREE TO INTERACT.
WHEN WE LOOK AT WHAT THE NIH HAS
BEEN -- THE NUMBER OF AWARDS THE
NIH HAS BEEN MAKING INTO THREE
CATEGORIES.
ON THE LEFT YOU HAVE THE NIH AND
ALL INSTITUTES AND CENTERS THAT
HAVE FUNDING AUTHORITY AND ON
THE RIGHT YOU HAVE THE NIAMS AND
OUR SCALE OUR Y AXIS IS VERY
DIFFERENT.
YOU CAN SEE OVER THE LAST FIVE
YEARS NIH HAS BEEN STEADILY
INCREASING ITS INVESTMENT IN
THESE SCIENTIFIC CATEGORIES AND
THAT IS ALSO TRUE FOR THE NIAMS.
NOW, IF YOU LOOK YOU'LL SEE IN
THE GREEN BARS THOSE ARE THE
PROJECTS AND HOW THEY REPORT THE
DATA.
THAT REFLECTS THE FACT THERE ARE
A NUMBER OF AWARDS, TYPES OF
AWARDS THE NIH MAKES IN WHICH
THERE MAY BE A SINGLE PROJECT OR
MAY BE MULTIPLE PROJECTS UNDER
ONE UMBRELLA AWARD.
USUALLY THOSE ARE MULTI
COMPONENT AWARDS AND THERE COULD
BE TWO OR THREE CORES AND THEY
WOULD BE CATEGORIZED AS A
SUBPROJECT AND MAY HAVE RESEARCH
PROJECTS.
THOSE ARE COUNTED INDIVIDUALLY
NIH RECEIVES THEM AS
MULTI-COMPONENT AND A STUDY
SECTION LOOKED AT EACH
INDEPENDENTLY AND GIVES THEM
SCORE AND WHEN IT COMES TO
CODING, THE SYSTEM RECOGNIZES
THEM AS DISTINCT PROJECTS AND
CODES THEM INDEPENDENTLY
SEPARATELY I SHOULD SAY.
THE NIAMS HAS A FAIR NUMBER OF
SUBJECT PROJECTS INCLUDED AND
FUNDED AND THAT'S NOT REALLY
PRICING.
-- SURPRISING.
IN THE NEXT SLIDE WE SHOW YOU A
LITTLE BIT -- I HOPE YOU SEE
SLIDE SIX.
BUT SLIDE SIX BASICALLY SHOWS
THE FUNDING DISTRIBUTION BY SUB
PROJECTS.
ON THE TOP TABLE YOU HAVE THE
NIAMS DATA.
YOU SEE THE FUNDING FOR THE LAST
FIVE YEARS FOR THEE THREES RDCD
CATEGORIES FOR PROJECTS WAS $169
MILLION OUT OF WHICH 34% WAS
AWARDED IN SUBPROJECTS.
VERSUS THE NIH IN THE BOTTOM
TABLE WHERE SOME REPRESENT 14%
OF THE FUNDING AND 25% OF THE
NUMBER OF AWARDS.
THE TABLE INDICATES THE NIAMS
SUPPORTING DATA SCIENCE AND
INFORMATION TECHNOLOGY TO LARGER
DURING THROUGH SUBPROJECTS.
SO THE NEXT SLIDE SO WE WANTED
TO KNOW HOW THAT IS DISTRIBUTED
ACCORDING TO THE FUNDING
MECHANISMS THE NIH REPORTS TO
CONGRESS.
THIS TYPE OF TABLE IS THE TYPE
OF TABLE YOU SEE WHEN INSTITUTES
REQUEST THEIR BUDGETS TO THE
CONGRESS AND HOW CONGRESS AWARDS
BUDGET TO THE NIAMS.
THESE ARE THE CATEGORIES IN THE
BUDGET TABLES.
YOU CAN SEE I POINTED OUT IN RED
SOME INTERESTING CATEGORIES I
THINK ARE INTERESTING BECAUSE OF
TWO REASONS.
THE TWO QUESTIONS WE ARE USUALLY
ASKED WHEN PRESENTING
DISTRIBUTION FUNDING ACCORDING
TO FUNDING MECHANISMS IS HOW
MUCH OF THIS IS REPRESENTED IN
THE INVESTIGATOR INITIATED POOL?
THAT TYPE OF RESEARCH IS
CAPTURED SEVERAL PLACES HERE BUT
THE MOST IMPORTANT CATEGORY IS
KNOWN AS THE STTR FUNDING
CATEGORY BECAUSE THAT INCLUDES A
NUMBER OF THE R21s ETCETERA.
IF YOU CARE THE NIH PERCENTAGE
OF FUNDING AND THE NIAMS
PERCENTAGE OF FUNDING WE HAVE A
SIMILAR NUMBER THERE.
WE HAVE A LITTLE BIT MORE
PERCENTAGE OF THE FUNDING IN THE
OTHER RESEARCH CATEGORY AND WE A
LITTLE BIT MORE THAN THE NIH
AVERAGE ON RESEARCH CENTERS
LABELLED IN RED.
THERE'S SOME DIFFERENCES IN THE
SPIR CATEGORY AND WE HADN'T HAD
TIME TO DIG DEEPER IN THE
CATEGORY.
THERE MAY BE SOME DIFFERENCES
THERE AS WELL.
WE SHOW YOU MORE DETAIL AND THE
NIAMS DISTRIBUTION AND BREAKS IT
DOWN TO R01s AND K AWARDS,
ETCETERA.
YOU SEE A NUMBER OF THE PROGRAMS
IS SIGNIFICANT BUT THERE'S A
FAIR NUMBER OF PROJECTS THAT ARE
FUNDED AS R01, R21s.
ONE ITEM I WAS HAPPY TO SEE IS A
FAIR NUMBER IN THE K CATEGORIES.
IT SUGGEST THE JUNIOR
INVESTIGATORS ARE EMBRACING THIS
AREA OF SCIENCE WHICH IS
ENCOURAGING.
THE REFERENCES TO THE WORKFORCE
AND WHAT WE HAVE OBSERVED IS
THAT JUNIOR INVESTIGATORS
EMBRACE SYSTEMS BIOLOGY AND
ANALYTICS AND EMBRACE ARTIFICIAL
INTELLIGENCE AND CARRY OUT
SCIENCE.
AND THIS COULD BE AT A STAGING
WHICH IS REFLECTS ON THE TYPES
OF AWARDS THE INSTITUTE MAKES.
THAT'S GOOD TO SEE.
THIS SHOWS THE DISTRIBUTION OF
DOLLARS PER FUNDING MECHANISM.
I WANT TO DRAW YOUR ATTENTION TO
THE BIG BLUE SECTOR ON THE
CIRCLE ON THE LEFT.
THERE'S A SIGNIFICANT AMOUNT OF
FUNDING WHICH GOES TO A PROJECT.
AND THIS IS -- THIS REFLECTS NOT
A CONDITION BUT A FACTOR A
CIRCUMSTANCE OF THE WAY THE
NIAMS HAS BEEN ENGAGING IN
FUNDING OF PROJECTS THAT ARE OF
HIGH STRATEGIC VALUE.
THE U24 PRESENTED IN THE SLIDE
IS A COMPONENT OF THE BACK PAIN
CONSORTIUM.
IT'S A HEAL INITIATIVE THAT THE
NIAMS IS PROVIDING THE
LEADERSHIP ON AND ADMINISTERING
AND OUR EXTRAMURAL TEAM IS DOING
A FANTASTIC JOB WITH THE
LEADERSHIP.
IT'S A DATA ALGORITHM AND
COORDINATING CENTER FOR THE
BACKPACK INITIATIVE.
ALL THE FUNDING YOU SEE HERE
COMES FROM THE DOD ACTUALLY.
IT'S O.D. FUNDS AND A PROJECT
WE'RE ADMINISTERING AND RELEVANT
TO OUR COMMUNITY AND SHOWN AND
REPORTED HERE.
WE THEN WANTED TO SEE HOW ARE
THE AWARDS DISTRIBUTED BY
SCIENTIFIC AREA?
TO BE CONSISTENT WITH THE
ANALYSIS THAT I PRESENTED, THE
NEXT SLIDE, SLIDE 10 PRESENTS
THE AWARDS ACCORDING TO VERY
CLOSE TO THE WAY WE REPORT TO
THE CONGRESS AND MAKE OUR BUDGET
REQUESTS.
SO NOT SURPRISINGLY MOST THE
BACK PAIN PROJECTS ARE INCLUDED
AND FLORIDA OUR BIOLOGY OF
DISEASES AND ORTHOPEDICS IT'S
PERHAPS LARGER THAN IT WOULD BE
OTHERWISE BUT WE ARE HAPPY TO
HAVE THOSE FUNDS AND TO HAVE A
PROJECT IN THE PORTFOLIO.
YOU CAN SEE ALSO THAT CENTERS
REPRESENT I'M SORRY, THE CENTERS
PROGRAM REPRESENTS A SIGNIFICANT
COMPONENT IN TERMS OF THE
DISTRIBUTION OF AWARDS BY
MISSION AREA.
FINALLY IN THE NEXT SLIDE, I
JUST WANTED TO POINT OUT THE
FACT THAT IF YOU LOOK AT 2019
YOU'LL SEE A SPIKE IN THE
FUNDING DUE TO THE YEAR WE HAD
THE BACKPACK FUNDED AND AWARDS
OCCUR IN 2022.
I INCLUDE THE SLIDE BECAUSE I
WANTED TO HIGHLIGHT THE VALUE OF
HAVING MISSION AREAS THAT ARE
IMPORTANT WITHIN THE INSTITUTE
REPRESENTED IN THE TRANS-NIH
ACTIVITIES BECAUSE IT GIVES THE
INSTITUTE AN OPPORTUNITY TO
ADVANCE THE SCIENCE AND ADVANCE
SOME OF THE NEW EMERGING
OPPORTUNITIES THAT WOULD BE VERY
DIFFICULT TO DO OTHERWISE.
THERE'S A REPORTING TOOL THAT
LOOKS AT HOW DIFFERENT CONCEPTS
ARE REPRESENTED IN THE PORTFOLIO
YOU'RE LOOKING AT.
IT'S BASED ON THE REPRESENTATION
OF PARTICULAR TERMS AND THEY ARE
WEIGHTED.
THIS IS DONE BY ALGORITHMS IN
THE SYSTEM.
THE TERM AS THEY APPEAR IN THE
AWARD AND IN THE ABSTRACT AND IN
THE SPECIFIC AIMS.
SO THIS IS CURATED BUT IT
REFLECTS THE AREA OF SCIENCE
WE'RE LOOKING AT BUT NOT VERY
SPECIFIC.
FOR EXAMPLE, IF YOU LOOK CLOSELY
YOU'LL SEE THERE ARE TERMS THAT
HAVE SPECIFIC AIMS WHICH IS NOT
VERY HELPFUL.
NEVERTHELESS WITH WE'RE
CAPTURING THE TRENDS AND THE
TYPE OF SCIENCE WE WANTED TO
CAPTURE.
THIS IS A PRELIMINARY ANALYSIS
AND ALLOWS US TO STATE THAT THE
NIAMS GRANTS IN FUNDING AND
MACHINE LEARNING AND
INTELLIGENCE ARE IN PARALLEL
WITH THE NIH TRENDS AND WE'RE
SEEING STEADY INCREASES OVER THE
LAST FIVE YEARS.
OUR EFFORTS IN THIS TYPE OF
RESEARCH IS PRIMARILY THERE'S A
SIGNIFICANT PORTION OF THE
EFFORT BEING CONDUCTED THROUGH
THE CENTERS PROGRAM AND I
INTERPRET AS A GOOD THING
BECAUSE THE CENTERS ARE DESIGNED
TO SUPPORT THE RESEARCH BASE AND
THEREFORE WE EXPECT, I EXPECT A
LOT OF THE RESOURCES CREATED
THROUGH THE CENTERS IN
PARTICULAR THAT ARE PART OF OUR
PROGRAMS WILL BE SHARING SOME OF
THOSE ALGORITHMS WITH
RESEARCHERS IN THE COMMUNITY.
THAT TO ME IS AN ENCOURAGING
SIGN.
OTHER RESEARCH ARE HEAVILY
REPRESENTED IN THE OTHER
RESEARCH PROJECTS COMPARED TO
THE NIH IN PART DUE TO THE
SPECIAL PROJECTS AND OF COURSE
BECAUSE OF THE INVESTMENT.
INVESTIGATOR INITIATED RESEARCH
IS REPRESENTED AND IS IT IN THE
CASE AREAS SUGGEST THERE'S A
GROWING NUMBER OF SENIOR
INVESTIGATORS AND RAISING THIS
IDEA.
FINALLY, I WANTED TO HIGHLIGHT
THE FACT THERE'S HIGH IMPACT
PROJECTS THAT ALLOW US TO
ADVANCE THE SCIENCE AND WE'LL BE
ABLE TO CONTINUE TO SHARE THOSE
WITH THE REST OF THE COMMUNITY.
WE'LL LOOK AT THE DATA SETS NON
PUBLIC ALLOWING US TO LOOK AT
APPLICATIONS AND AWARDS AND DIG
DEEPER INTO WHAT ARE THE TYPE OF
PROJECTS PRODUCING DATA SCIENCE
AND CLINIC AND EPIDEMIOLOGY
STUDIES.
ARE THEY OMIC STUDIES OR TYPES
AND HOW TO DISTRIBUTE ACCORDING
TO MORE GRANULAR VERSIONS OF OUR
SCIENTIFIC PROGRAMMATIC AREAS.
I HAVE A LINK AND YOU CAN SEE
THE DATA AND SEE THE INDIVIDUAL
AWARDS AND DIG DEEPER IF YOU'RE
INTERESTED.
THERE'S MANY WAYS TO SORT THE
DATA.
THIS IS ONE WAY WE CHOSE IN PART
TO ESTABLISH A BASELINE TO HELP
FIGURE OUT AND WHAT THE GAPS AND
OPPORTUNITIES ARE THINKING
FORWARD FOR A STRATEGIC PLAN FOR
DATA SCIENCE FOR THE NIAMS.
I'LL STOP HERE AND HAPPY TO
ANSWER ANY QUESTIONS.
>> THANK YOU.
WE'RE INVESTING IN MORE HEAVILY
IN DATA SCIENCE WITH THE K
SERIES AND THE INVESTMENT IS IN
THE CENTERS.
WE'RE RUNNING A LITTLE BIT
BEHIND BUT BY ALL MEANS IF
THERE'S QUICK QUESTIONS FOR
SUSANNA LET'S TAKE THEM NOW
BEFORE WE GO TO THE NEXT
PRESENTATION?
WE CAN ALSO CIRCLE BACK
QUESTIONS THAT COME TO MIND.
I'M NOT SEEING HANDS UP AT THE
MOMENT.
LET ME INTRODUCE OUR NEXT GUEST.
WHAT YOU'LL HEAR NEXT IS ABOUT A
PILOT PROJECT FOCUSSED ON OUR
IRP.
I THINK IT NICELY DEMONSTRATE
OUR INTEREST IN COMMITMENT TO
DATA DATA MANAGEMENT AND
CREATING AN ENVIRONMENT TO
SUPPORT DATA SHARING AS WELL.
OUR PRESENTERS ARE GOING TO BE
MR. PHIL WALTZ AND DR. HABNER.
AND THEY ARE WORK ON LEGACY
MIGRATION AND HARDWARE AND
SOFTWARE APPLICATIONS SUCH AS
THE DIAMOND PART YOU'LL BE
HEARING ABOUT AND DR. HAPNER
JOINED MUSCLE STEM CELLS AND GEN
REGULATOR IN 2014 AND HIS
LABORATORY PRODUCES LARGE
AMOUNTS OF DATA PARTICULARLY
FROM LARGE SCALE QUANTITATIVE
METHODS SUCH AS NEXT GENERATION
SEQUENCING AND MODERN MASS SP
SPECTOMETRY AND LOOK AT POST
TRANSCRIPTIONAL GENE REGULATION
PROCESSES.
WITH THAT INTRODUCTION I THINK
I'M TURNING THINGS OVER TO PHIL
TO START OFF HERE.
>> GOOD AFTERNOON.
I'M GOING TO PRESENT THE
CATALOG.
IT'S A DATA SCIENCE TOOL
DEVELOPED TO SUPPORT
ACCELERATING DATA GROWTH AND THE
NIH POLICY FOR DATA MANAGEMENT
SHARING.
I FIRST WANT TO THANK NIAMS
INVESTIGATORS AND STAFF FOR
THEIR CONTRIBUTIONS IN MAKING
THE CATALOG SUCCESSFUL.
IT'S BEEN A MULTI-YEAR JOURNEY.
WORKING WITH NIAMS INVESTIGATORS
TO MANAGE EXPANDING DATA GROWTH
AND ONGOING TASKS, PLANNING EACH
YEAR INCLUDES SIZING AND OFTEN
PURCHASING MORE STORAGE HARDWARE
EACH YEAR.
IN OCTOBER 2020, THE NIH
RELEASED THE UPDATED POLICY FOR
DATA POLICY AND SHARING
EFFECTIVE IN JANUARY.
WORKING WITH TWO S.T.E.M.
INTERNS WE RESEARCHED THE DATA.
IN 2020 AND 2021 WE COMPLETE THE
NIAMS DATA DISCOVERY ANALYSIS
AND A FOLLOW-ON PROJECT FOR THE
DATA MANAGEMENT DEEPER DIVE.
IN OCTOBER, 2021, THE REVIEW OF
THESE PROJECTS HIGHLIGHTED THE
NEEDS AND OPPORTUNITIES FOR
NIAMS TECHNOLOGY BRANCH TO TAKE
THE LEAD AND ESTABLISH THE DATA
CATALOG PILOT.
THE PILOT STARTED WITH THREE KEY
GOALS.
FIRST WAS TO WORK WITH THE IRB
INVESTIGATORS TO LEARN THEIR
DATA AND HOW BEST TO BUILD A
DATA MANAGEMENT TOOL AND SECOND
BUILD A CATALOG FOUNDATION
SUPPORTING THE RESEARCH DATA AND
THREE BUILD IN THE APPLICATION
FOR SUPPORT FOR THE DATA
MANAGEMENT AND SHARING POLICY.
THIS MONTH THE DIAMOND CATALOG
IS IN PRODUCTION.
DURING THE PILOT SPEAKING WITH
PRINCIPLE INVESTIGATORS AND
SCIENTISTS THEY SHARED THEIR
PAIN POINTS RELATED TO DATA
ACCESS, STORAGE AND SHARING.
WE HEARD ABOUT DATA ON SERVERS
AND MACHINES AND FINDING DATA
SETS CAN TAKE MANY HOURS TO
PROCESS AND SHARING DATA WITH
COLLABORATORS CAN ALSO TAKE MANY
HOURS AND SOMETIMES IT'S
DIFFICULT TO GET TO THE SERVERS
AND IT CAN BE HARD TO SAVE OUR
OWN COPY.
THERE'S NO DEDICATED SPACE TO
SHARE.
SOME EQUIPMENT IS NOT ON THE
NETWORK.
SOMETIMES THE DATA IS IN TWO
PLACES AND WE HAVE A FURTHER
LIST OF QUOTES DURING OUR WORK
SESSIONS.
SO ENGAGING THE PROCESS
WORKSHOPS AND CO-CREATION
SESSIONS WITH INVESTIGATORS AND
FINDINGS WERE ANALYZED AND
RESEARCH DATA TYPES AND WORK
FLOW AND PROCESSING CHALLENGES.
THE DATA MANAGEMENT CHALLENGES
ARE IN TWO CATEGORIES.
THE RESEARCH CHALLENGES INCLUDE
MOST PRINCIPLE INVESTIGATORS
WERE NOT AWARE OF THE DETAILS IN
NEW POLICY AND APPROACHES TO
STORING, MANAGING DATA DIFFER
VASTLY ACROSS THE LABS.
MOST LAB GROUPS DONE ARCHIVE
THEIR DATA SO FINDING AND
SHARING AS SO THE TIME.
STANDARDS ARE LACKING.
THERE'S NO DATA RETENTION
POLICIES FOR UNPUBLISHED
RESEARCH DATA AND IMPROVED
MANAGEMENT, DATA MANAGEMENT
OPTIMIZE DATA SHARING WILL
DEFINITELY BE A CULTURE SHIFT.
ALSO FOR EFFICIENT COMPLIANCE
WITH THE POLICY FOR DATA
MANAGEMENT SHARING WILL REQUIRE
MORE ORGANIZED DATA.
SOME CHALLENGES INCLUDE OVER THE
PAST THREE YEARS, NIAMS DATA HAS
BEEN 20% EACH YEAR.
THIS YEAR IT'S PLANNING TO
DOUBLE THE RATE WITH PLANNING UP
TO 62 TERABYTES EACH MONTH.
THE STORAGE IS AT NEAR CAPACITY
AND SOLUTIONS ARE REQUIRED AND
PROVIDING DATA SOLUTIONS REQUIRE
UPDATING OUR DATA ARCHIVING
POLICIES AND STORING DATA IN THE
CLOUD, AND DATA SETS ARE A FEW
OF THE IMPROVEMENTS.
TODAY WE HAVE A TOOL TO HELP.
A FUNCTIONALIZED DATA CATALOG
AND DIAMOND IS CREATED FOR
RESEARCHERS TO ORGANIZE AND
DOCUMENT RESEARCH DATA IN THE
CENTRAL LOCATION.
IT ACCELERATES FINDING AND
SHARING DATA.
RESEARCHERS CAN ACCESS AND ADD
THEIR PROJECT AND EXPERIMENT
DATA WITH RELATED INFORMATION
SUCH AS PROTOCOLS, EXPERIMENT
TYPE, INSTRUMENTATION AND RUN
DATE THEY CAN ALSO ATTACH
ARTIFACTS AND FILES RELATED TO
THE EXPERIMENT ALL WITH DATA
HISTORY TRACKING AND DATA SEARCH
CAPABILITIES.
DIAMOND SUPPORTS WITH ORGANIZED
DATA SETS AND INCLUDE VISIBL
VISIBLITY -- VISIBILITY AND
ENHANCE SHARING OPPORTUNITIES.
IT'S DESIGNED TO SUPPORT DATA
SCIENCE FOUNDATION SUPPORTS
PRINCIPLES WITH AVAILABLE DATA
SHARING AND AS DEFINED IN THE
NIH POLICY.
PLANNING FOR AVAILABILITY AND
LARGER SCALING IN LABS AND NIH
I.C.s, IT WAS BUILD IN THE
AMAZON CLOUD WITH SINGLE SIGN
ON.
THE DIAMOND APPLICATION FEATURES
SUPPORT AND LINEAGE AND HANDLING
AND FINDABLE DATA IN CENTRAL
ACCESS LOCATION AND A WEB-BASED
INTERFACE AND SUPPORTS
RESEARCHERS PREFERRED DATA
HANDLING METHODS.
WHEN STUDIES ARE COMPLETE THE
RESEARCH DATA WILL BE ORGANIZED
AND CATALOGED READY TO POPULATE
IN PUBLIC REPOSITORIES.
BUILDING THE APPLICATION USING
THE STEAM PUNK ACCESS AND
STARTED WITH LIMITED SCOPE
FOCUSSED OB ONE GROUP AND WE
CAPTURED DATA TYPE SIZES AND LAB
RESEARCH WORK FLOWS.
TODAY'S DIAMOND IS CREATED FROM
MANY IRP RESEARCH STAFF IN THE
NIAMS LEADERSHIP.
WE'VE REACHED OUT TO RESEARCHERS
TO ONBOARD NEW LABS AND I.C.s.
OUR OUTREACH IS ALMOST
COMPLETED.
WE LOOKED TO THE FUTURE.
THE DIAMOND VISION IS TO
CONTINUE MOMENTUM MAKING
IMPROVEMENTS TO EXPAND THE
OUTREACH TO ADDITIONAL NIAMS
LABS AND I.C.s.
OUR APPROACH IS DEVELOPMENT
PROCESS CONTINUALLY THINKING HOW
THE CATALOG CAN BE ENHANCED AND
SCALED TO MEET ADDITIONAL NEEDS.
FURTHER ENGAGEMENT TO INITIATIVE
THE CHANGE IN DATA MANAGEMENT
CULTURE ENHANCE DATA PERMISSION
AND SHARING AND EXPERIMENT AND
FILE LEVEL EXPANDED ROLL OUT TO
LABS AND CATALOG FUNCTIONALITY
TO BUILD IN A MORE EFFICIENT
CARING CAPABILITIES AT THE
PROJECT AND EXPERIMENT LEVEL AND
DEVELOPING INTEGRATION WITH
EXISTING HPC DATA SOURCES AND
BUILDING PREDICTIVE ANALYTICS.
THE SUCCESS IS A RESULT OF MANY
HOURS WORKING WITH MARCUS AND
HIS LAB TEAM.
HE'S AVAILABLE TO SHARE HIS
SCIENCE INSIGHT WITH THE DIAMOND
APPLICATION.
>> THANK YOU, PHIL.
MY GROUP AND THE NIAMS ARE FOUR
OR FIVE POST-DOCS STUDYING POST
TRANSCRIPTIONAL GENE REGULATION
AND SPLICING AND RNA TURNOVER
AND OTHERS AND CONTROLLED BY
BINDING PROTEINS.
SO BY NECESSITY WE HEAVILY USE
RNA SEQ AND RELATED TECHNIQUES
GENERATING LARGE AMOUNTS OF
DATA.
WE ARE VERY HAPPY TO HAVE ACCESS
TO A TOOL SUCH AS DIAMOND AND
REQUIRE ALL TO DEPOSIT THEIR DEA
SETS IN THE DATABASE AND IT
HELPS WITH LONG RUNNING PROJECTS
BETWEEN MULTIPLE FELLOWS AND
ALLOWS REVISITING OF ALL DATA
AND UNPUBLISHED OLD DATA.
IMPORTANTLY, INCREASES
EFFICIENCY BY EXPERIMENTS AND
PREPARES US TO STAY IN
COMPLIANCE WITH DATA SHARING AND
MANAGEMENT POLICIES.
THANK YOU VERY MUCH.
>> SO THANK YOU BOTH.
THE PROJECT IS NOT EASY AND
SPECIAL THANKS TO MARCUS FOR
STEPPING UP AND SERVING AS THE
BETA TESTER.
I REALIZE WE'RE RUNNING A LITTLE
BIT OVER AND A WANT TO GIVE
FOLKS PLENTY OF TIME FOR A BREAK
BUT WANT TO GIVE FOLKS AN
OPPORTUNITY INCLUDING SUSAN IF
SHE HAS QUESTIONS TO RAISE
QUESTION FOR FILL, MARCUS,
OTHERS ON OUR TEAM THAT MIGHT BE
ABLE TO ADDRESS THEM.
>> ARE YOU PLANNING ON MAKING
THE SOFTWARE AVAILABLE TO THE
COMMUNITY?
HOW'S THAT WORK?
>> OUR INTENT IS TO PRESENT THIS
ACROSS THE NIH AND LET THE OTHER
I.C.s BE AWARE OF WA WE'RE DOING
IN THE SPACE AND ONCE WE DO THAT
WITH A LITTLE CERTAINLY LOOK AT
OTHER OPPORTUNITIES.
>> THANK YOU FOR YOUR SUPPORT OF
THE NIAMS IRP.
WE LOOK TO THOSE SUPPORTIVE AND
I CAN JUST ADD SOME COMMENTS.
THE REACH OUT PROCESS TO
INTERVIEW PROCESS CAPTURING THE
DATA TYPES IS A WELL KNOWN
PROCESS WE'VE KNOWN WITH 40 PLUS
RESEARCHERS AND BUILT IN AMAZON
SO THE SCALABILITY IS NOT A
CONCERN.
>> SUSAN.
>> I WANT TO COMMEND YOU FOR THE
WORK YOU'RE DOING.
EXCITED TO SEE THIS COME
TOGETHER AND WOULD LOVE TO
CONNECT ON HOW WE CAN RAISE
AWARENESS ACROSS THE INSTITUTES
AND CENTERS FOR THE WAY YOU'VE
DEVELOPED THIS AND TO SEE WHAT
WE CAN DO ACROSS THE IRP.
THIS IS REALLY FANTASTIC WORK.
MAYBE EVEN GROUNDBREAKING FOR
THE IRP.
>> IF I CAN SHARE ANECDOTALLY
TALKING TO COLLEAGUES THEY'D BE
INTERESTED IN HAVING ACCESS TO
SUCH A TOOL.
>> OTHER QUESTIONS FOR THE TEAM?
SUSAN, THANK YOU FOR STAYING.
I APPRECIATE THAT.
>> WOULD YOU LIKE TO TAKE ABOUT
THE PAIN AND SUFFERING YOUR
INFLICTING ON THE LAB GROUP.
>> I'M TRYING TO PUSH AS MUCH AS
I CAN.
THIS TAKES TIME.
AND THERE'S A RISE IN THE USE OF
THE SEQUENCING TECHNOLOGIES BUT
WOULD HAVE BEEN USEFUL TO HAVE
THAT IF WE HAD THAT FROM THE
OUTSET AND NOT DO FIVE YEARS
WORTH OF DATA AND MAKE USEFUL
EXPERIMENTS.
>> AND MOVING FORWARD AS NEW
FOLKS COME ON BOARD OR OTHER
ASPECTS FOLKS WANT TO SHARE.
FAYE.
>> THIS IS AN INTERESTING
PROJECT.
I WANT TO ASK A QUESTION.
I'VE BEEN CURIOUS, WHEN WE TALK
ABOUT THE FAIR PRINCIPLE IS SO
IMPORTANT.
A CRITICAL PART IS THE COMMON
DATA ELEMENT AND WORKING WITH
BASIC LABS AND I'M CURIOUS HOW
DOES THAT APPLY TO THE BASIC
SCIENCE COMMON DATA ELEMENTS AND
WHAT'S BEING DONE AND LOOK AT
THE ENTERPRISE.
AND THERE'S A START IN HAVING AN
ORGANIZED WAY OF DEALING WITH A
DATA WE HAVE.
AND HAVING THE DATA SETS THAT
ARE SHARED FROM PUBLIC
REPOSITORIES.
THAT PART IS ALREADY DEALING
WITH UNPUBLISHED DATA AND
PROBABLY HALF THE DATA WE HAVE
OR MORE ARE AT THE MOMENT
UNPUBLISHED BUT HAVE TO BE
SHARED MAINLY BETWEEN LAB
MEMBERS AND ALSO OUTSIDE.
THIS WAS OUR MAIN PAIN POINT AND
THIS MONTH THE OUTREACH ISMAN
NIAMS AND WE'RE LOOKING AT DATA
AND WHERE IT RESIDES AND THE
WORK FLOW PROCESS AND FROM THE
PROFILES WE'LL BE ABLE TO
UNDERSTAND HOW THE TOOL
ADDRESSED THEIR NEEDS AND
CHALLENGES.
>> IN OF HOW YOU ARE AUTOMATING
THIS.
SOME AUTOMATIONS INCLUDE TRYING
TO DO THE PART THAT MAKES IT
DIFFICULT SOME LIKE THAT WE ARE
INCLUDING THE TOOLS IN THE
PROCESS AND WE'LL USE THAT AND
THOSE WHO STILL WANT TO DO THE
ANALYSIS ON THE OUTSIDE WILL
HAVE THE OPPORTUNITY AS WELL.
>> I WANT TO BE RESPECTFUL OF
EVERYBODY'S TIME ESPECIALLY
THOSE SITTING IN FRONT OF THEIR
COMPUTER MANY HOURS NOW.
THANK YOU AGAIN TO OUR
PRESENTERS IN THIS LAST SESSION.
SUSANA AND PHIL AND MARCUS AND
LE TANYA AND PHIL FOR STAYING
ON.
I WANT EVERYBODY TO PROMISE
THEY'LL STEP AWAY FROM THEIR
COMPUTER PART OF OUR BREAK.
I'D LIKE US TO RESUME AT 3:20
EASTERN.
THAT GIVES A SHORTER BREAK BUT
ALLOWS US TO END EARLIER IN THE
DAY IF THAT'S OKAY.
KATHY REMINDED ME THERE'S A
SEPARATE ZOOM LINK FOR THE NEXT
PART OF OUR MEETING WHICH IS THE
CLOSED SESSION.
SO WE ARE CONCLUDING THE OPEN
SESSION WITH THIS DISCUSSION AND
WE'LL RESUME 3:20 EASTERN
SEPARATE ZOOM LINK.
THANK YOU AGAIN TO ALL OF WHO
YOU CAN PRESENTED AND YOUR
QUESTIONS.
I LOOK FORWARD TO SEEING YOU IN
A BIT.