>>WELCOME BACK
TO THE NICHD ADVISORY COUNCIL.
TODAY IS OUR DAY OF REBECCAS.
DON'T GET CONFUSED BETWEEN
REBEKAH AND REBECCA.
WE'RE FIRST GOING TO HEAR FROM
MS. REBECCA ROSEN, DIRECTOR OF
THE NICHD OFFICE OF DATA
SCIENCE, AND SHARING.
SHE WILL START THE OPEN SESSION
OF DAY TWO WITH A PRESENTATION
ON DATA SHARING, WHICH IS WELL
TIMED BECAUSE THE NEW NIH POLICY
ON DATA MANAGEMENT AND SHARING
GOES INTO EFFECT TODAY, AS I
MENTIONED YESTERDAY.
SO I'M GOING TO HAND THE VIRTUAL
MICROPHONE OVER TO DR. REBECCA
ROSEN.
>>THANK YOU, DR. BIANCHI,
AND HAPPY DATA MANAGEMENT AND
SHARING POLICY DAY.
SO I AM GOING TO JUMP RIGHT IN.
TODAY I'M GOING TO TALK ABOUT
THE OFFICE OF DATA SCIENCES
SHARING.
I'LL GIVE AN OVERVIEW OF THE
POLICY FOR DATA MANAGEMENT AND
SHARING, AND THEN I'LL DISCUSS
THE DATA SHARING RESOURCES THAT
WE HAVE BEEN DEVELOPING FOR
NICHD'S STAFF AND INVESTIGATORS.
I'LL START WITH THE OFFICE OF
DATA SCIENCE AND SHARING.
THIS IS A NEW OFFICE, WE WERE
ESTABLISHED UNDER THE NICHD
STRATEGIC PLAN 2020.
SPECIFICALLY THE SCIENTIFIC
SECUREDSHIP GOAL 2, FACILITATING
DATA SHARING AND ACCESS TO
SPECIMENS.
THE OFFICE WAS ESTABLISHED IN
JULY 2021, WHEN I JOINED NICHD
FROM THE NATIONAL INSTITUTE OF
MENTAL HEALTH.
AND IN SEPTEMBER 2021, I HIRED
VALERIE AS MY DEPUTY DIRECTOR
AND AN NIH DATA SCHOLAR.
SINCE THEN, WE'VE HIRED JENNY
YANG, INFORMATICS PROGRAM
MANAGER, ELIZABETH CLERKIN,
PROJECTS MANAGER, STEPHANIE
TYSON, MANAGEMENT FELLOW, AND A
SUPPORT INTEGRATION SPECIALIST.
WE ARE NOW A TEAM OF SEVEN.
WE BRING EXPERTISE IN CLINICAL,
BEHAVIORAL AND BASIC RESEARCH,
DATA MANAGEMENT, DATA SCIENCE
AND DATA VISUALIZATION, CLINICAL
INFORMATICS, SOFTWARE
ENGINEERING, RESEARCH COMPUTING
AND PROJECT MANAGEMENT.
WE HAVE ESTABLISHED A MISSION
AND A VISION FOR THE OFFICE.
OUR VISION IS WE ARE WORKING
TOWARDS A CULTURE OF RESPONSIBLE
AND INNOVATIVE USE OF DATA AND
BIOSPECIMENS THAT ACCELERATES
RESEARCH AND IMPROVES HEALTH FOR
NICHD POPULATIONS.
IN ORDER TO ACHIEVE THAT VISION,
OUR MISSION IS TO DEVELOP A
DIVERSE, SECURE AND
INTEROPERABLE RESEARCH DATA
ECOSYSTEM, AND WE WILL ADVISE ON
BEST PRACTICES FOR DATA
COLLECTION, STANDARDS
MANAGEMENT, SHARING AND USE
ACROSS THE RESEARCH AND FUNDING
LIFECYCLES.
AND EVERYTHING THAT WE DO IS
FOCUSED ON ADVANCING THE MISSION
OF NICHD.
I THINK GENERALLY, IT'S COMMONLY
UNDERSTOOD WHAT ADVISING ON BEST
PRACTICES FOR DATA MAPPAGEMENT
ACROSS A LIFECYCLE MEANS BUT I
OFTEN HERE THE QUESTION, WHAT IS
THIS ECOSYSTEM?
SO WE HAVE DEVELOPED AN
ECOSYSTEM INFOGRAPHIC HERE ON
THE RIGHT WHICH IDENTIFIES THE
CORE COMPONENTS OF OUR NICHD
ECOSYSTEM.
IT'S PEOPLE, PROCESSES, DATA,
AND TECHNOLOGIES, AND IT REALLY
EMPHASIZES THE INCLUSIVENESS OF
THE PEOPLE WHO ENGAGE WITH OUR
ECOSYSTEM.
IT RESEARCHERS, CLINICIANS,
STAFF, AND RESEARCH PARTICIPANTS
AND THEIR FAMILIES.
THE ECOSYSTEM IS COMPRISED OF
THESE AND HOW THEY CONNECT
SHOULD BE BASED ON OUR
COMMUNITY'S DATA SCIENCE AND
DATA SHARING MEANS, SPECIFICALLY
WE HAVE THESE HIGH PRIORITY USE
CASES DRIVING THE DEVELOP M OF
THE COMPONENTS OF THE ECOSYSTEM
AND THE CONNECTIVITY OF THOSE
COMPONENTS.
OUR INTRAMURAL AND EXTRAMURAL
INVESTIGATORS NEED TO BE ABLE TO
SHARE THEIR DATA AND
BIOSPECIMENS TO ENCOURAGE
REPRODUCIBILITY AND BROAD
RE-USE.
THE BROAD RESEARCHER COMMUNITY
NEEDS TO BE ABLE TO FIND AND USE
OUR DATA AND SPECIMENS TO ENABLE
NEW AND INNOVATIVE RESEARCH, AND
THEY NEED TO BE ABLE TO ANALYZE
OUR DATA AND USE NEW TOOLS,
TRAININGS AND COMPUTE IN THE
CLOUD IDEALLY.
PARTICIPANT COMEUBTS SHOULD BE
ABLE TO VISUALIZE OUTCOMES OF
THEIR PARTICIPATION IN RESEARCH,
AND ULTIMATELY BENEFIT FASTER
FROM NEW DISCOVERIES.
OUR STAFF HAS A NEED TO TRACK
COMPLIANCE WITH NIH POLICIES AND
ALSO UNDERSTAND GOOD STEWARDSHIP
OF GOVERNMENT FUNDS.
AND NICHD LEADERSHIP NEEDS TO BE
ABLE TO ASSESS AND VISUALIZE THE
SCIENTIFIC RETURN ON OUR
INVESTMINVESTMENTS IN DATA AND
BIOSPECIMEN TESTING.
EXTRAMURAL, INTRAMURAL AND
ADMINISTRATIVE STAFF.
WE DO THIS BY WORKING ON THREE
STRATEGIC OBJECTIVES: TECHNICAL
INFRASTRUCTURE, WHERE WE ARE
DEVELOPING OUT THAT ECOSYSTEM I
JUST DESCRIBED, POLICY
IMPLEMENTATION AND COMPLIANCE,
WHERE WE ARE CREATING NICHD-WIDE
GUIDANCE AND IMPLEMENTATION
RESOURCE FOR ALL NIH DATA AND
SPECIMEN SHARING POLICIES, AND
STANDARDS, TRAININGS AND
PARTNERSHIPS, WHERE WE ARE
BUILDING OUT INFORMATIONAL
RESOURCES AND TOOLS ON DATA
SYSTEMS STANDARDS, ON TRAINING
ON DATA SCIENCE AND DATA SHARING
AND WE ARE DEVELOPING STRATEGIC
PARTNERSHIPS WITHIN NICHD,
ACROSS NIH, AT THE DEPARTMENT
LEVEL AND BEYOND TO SUPPORT THE
ACTIVITIES ACROSS TECHNICAL
INFRASTRUCTURE, POLICY,
IMPLEMENTATION AND COMPLIANCE.
I WANT TO EMPHASIZE, DATA
SCIENCE AND DATA SHARING DID NOT
START AT NICHD WHEN OUR OFFICE
IS ESTABLISHED.
THESE ACTIVITIES HAS BEEN A PART
OF THE NICHD RESEARCH FABRIC FOR
MANY YEARS.
SO WHEN WE FIRST ESTABLISHED THE
OFFICE, WE MET WITH NICHD
EXTRAMURAL AND INTRAMURAL STAFF
TO LEARN ABOUT THEIR DATA
SCIENCE AND SHARING ACTIVITIES
AND WHAT THEY NEEDED FROM OUR
NEW OFFICE.
THIS HELPED US TO ESTABLISH A
GOVERNANCE STRUCTURE WITHIN
NICHD TO ENSURE THAT ODSS IS
APPROPRIATELY LEVERAGING OUR
DIVERSE STAFF EXPERTISE AND
MEETING THEIR NEEDS IN THE DATA
SCIENCE AND SHARING SPACE.
AS YOU CAN SEE, OUR GOVERNANCE
STRUCTURE MAPS TO OUR STRATEGIC
OBJECTIVES, AND WE CURRENTLY
HAVE ADVISORY GROUPS VIA OUR
TECHNICAL INFRASTRUCTURE, POLICY
IMPLEMCATION AND COMPLIANCE
ACTIVITIES.
ON THE TECHNICAL INFRASTRUCTURE
SIDE, WE ESTABLISHED A DATA AND
SPECIMEN ECOSYSTEM WORKING GROUP
IN JANUARY OF LAST YEAR.
THE GROUP IS CHARGED TO DEFINE
THE SCOPE OF OUR NICHD RESEARCH
DATA AND SPECIMEN ECOSYSTEM, AND
ONCE IT'S DEFINED, TELL US WHAT
IT LOOKS LIKE, DEFINE THE
EXPECTATIONS FOR THE ECOSYSTEM
AND THE TIMELINE FOR BUILDING
OUT THE SYSTEM THROUGH
MEMBERSHIP THROUGH THEIR SUBJECT
MATTER EXPERTISE, AND THEY WILL
ALSO GUIDE US IN OUR ENGAGEMENT
WITH OTHER NICHD STAFF AND THE
BROADER RESEARCH COMMUNITY.
I'M NOT GOING TO READ THROUGH
EVERY NAME ON HERE, BUT I WILL
EMPHASIZE THAT WE HAVE BROAD
REPRESENTATION ACROSS NICHD ON
THIS GROUP.
WE HAVE FOUR STAFF FROM OUR
INTRAMURAL RESEARCH DIVISION,
AND WE HAVE A REPRESENTATIVE
FROM EVERY SCIENTIFIC EXTRAMURAL
PROGRAM BRANCH AND THE NATIONAL
CENTER FOR MEDICAL
REHABILITATION AND RESEARCH.
ON THE DATA -- ON THE POLICY AND
IMPLEMENTATION SIDE, WE HAVE AN
EXTRAMURAL DATA SHARING
COMMITTEE.
THIS COMMITTEE PRECEDED OUR
OFFICE, IT WAS ESTABLISHED IN
2018.
IT'S CURRENTLY LED BY OUR OFFICE
AND REBEKAH RASOOLY.
IT COLLECTIVELY DEFINES POLICY
IMPLEMENTATION STRATEGIES AND IT
INFORMS THE DEVELOPMENT OF
RESOURCES FOR NIH DATA SHARING
POLICIES.
THE MEMBERSHIP ON THIS DATA
SHARING COMMITTEE IS INCREDIBLY
BROAD.
IT COVERS OUR 12 EXTRAMURAL
SCIENTIFIC BRANCHES AND NCMRR.
ALSO WE HAVE REPRESENTATION FROM
OUR DEA BRANCHES, OSPRA, AND
INTRAMURAL.
I NAMED HERE EACH OF THE PRIMARY
MEMBERS IN THE DATA SHARING
COMMITTEE.
I WILL POINT OUT THAT EACH OF
THESE HAS AN ALTERNATE MEMBER AS
WELL, SO IT'S AN INCREDIBLY
ACTIVE MEETING.
WE MEET TWICE A MONTH.
WE ALSO ESTABLISHED JANUARY OF
LAST YEAR AN INTRAMURAL DATA
SHARING COMMITTEE.
BECAUSE THE INTRAMURAL RESEARCH
COMMUNITY DOES HAVE SPECIFIC
NEEDS WHEN IT COMES TO
IMPLEMENTING THE POLICY, THE
CHARGE OF THIS COMMITTEE IS TO
DEFINED THE NICHD INTRAMURAL
IMPLEMENTATION OF DATA SHARING
POLICIES, AND TO IDENTIFY AND
PRIORITIZE THE RESOURCES THAT
ODSS WILL DEVELOP TO FACILITATE
THEIR RESEARCHERS' ABILITY TO
COMPLY WITH DATA SHARING
POLICIES.
THE REPRESENTATION ON THIS GROUP
IS ALSO BROAD.
IT COVERS CLINICAL, POPULATION
HEALTH RESEARCH, AND BASIC
SCIENCE.
AND I DO WANT TO THANK EVERYBODY
ON THESE GROUPS.
I APOLOGIZE FOR NOT NAMING THEM
BUT ALL OF THE SLIDES ARE
PUBLICLY AVAILABLE.
I'LL NOW PIVOT TO DATA SHARING
RESOURCES FOR NICHD STAFF AND
INVESTIGATORS.
THE POLICY HAS TWO REQUIREMENTS.
A NUMBER OF EXPECTATIONS AND
DEFINITIONS.
THE REQUIREMENT FIRST IS THAT
RESEARCHERS MUST PROSPECTIVELY
PLAN FOR HOW SCIENTIFIC DATA AND
METADATA WILL BE BOTH MANAGED
AND SHARED.
SCIENTIFIC DATA IS DEFINED, TWO
IMPORTANT DEFINITIONS IN THE
YELLOW BOX, AS THE RECORDED
FACTUAL MATERIAL COMMONLY
ACCEPTED IN THE SCIENTIFIC
COMMUNITY AS SUFFICIENT QUALITY
TO VALIDATE AND REPLICATE
RESEARCH FINDINGS, REGARDLESS OF
WHETHER THOSE DATA ARE USED TO
SUPPORT SCHOLARLY PUBLICATIONS.
SO RESEARCHERS ARE REQUIRED TO
PLAN FOR HOW THOSE DATA AND
METADATA ARE SHARED AND THAT
PLAN SHOULD ALSO CONSIDER ANY
POTENTIAL RESTRICTIONS FOR
LIMITATIONS TO DATA SHARING.
IN THAT PLAN, RESEARCHERS ARE
EXPECTED TO MAXIMIZE DATA
SHARING, AND THE POLICY HAS
DEFINED DATA SHARING AS THE ACT
OF MAKING SCIENTIFIC DATA
AVAILABLE FOR USE BY OTHERS.
FOR EXAMPLE, THE LARGER RESEARCH
COMMUNITY, INSTITUTIONS, AND KEY
HERE IS THE BROADER PUBLIC.
FOR EXAMPLE, VIA AN ESTABLISHED
REPOSITORY.
SO RESEARCHERS ARE EXPECTED TO
SHARE DATA IN REPOSITORIES AND
THE TIME LINES ARE VERY CLEAR,
AT THE TIME OF PUBLICATION OR
END OF A PERFORMANCE PERIOD,
WHICHEVER COMES FIRST.
AND THE SECOND REQUIREMENT IS
COMPLIANCE.
ONCE A PLAN IS APPROVED,
RESEARCHERS ARE REQUIRED TO
COMPLY WITH THAT APPROVED PLAN
AND FOR EXTRAMURAL RESEARCHERS,
IT BECOMES A TERM AND CONDITION
OF AWARD.
NAD TO IN ADDITION TO THE MAIN Y
OF THE OFFICE, WE HAVE
SUPPLEMENTAL GUIDE NOTICES AND
ONE OUTLINES THE ELEMENTS TO
INCLUDE IN A DATA MANAGEMENT AND
SHARING PLAN.
IN GENERAL, PLANS SHOULD BE TWO
PAGES IN LENGTH, BUT THERE IS NO
HARD LIMIT DEFINED.
PLANS SHOULD INCLUDE ALL ASPECTS
OF DATA MANAGEMENT AND SHARING
TO COMPLY WITH BOTH DATA
MANAGEMENT AND SHARING POLICY
AND THE NIH GENOMIC DATA
SHARING POLICY IF IT'S
APPLICABLE.
THE OFFICE OF SCIENCE POLICY AND
EXTRAMURAL RESEARCH OFFICES,
THEY HAVE MADE AVAILABLE AN
OPTIONAL FORMAT PAGE FOR DATA
MANAGEMENT AND SHARING PLANS.
IT'S ON THE SHARES.NIH.GOV
WEBSITE AND THERE ARE OTHER
TEMPLATES AVAILABLE.
THESE ARE OPTIONAL.
THE PLANS SHOULD INCLUDE THESE
SIX ELEMENTS: DATA TYPES AND
RESEARCHERS SHOULD BRIEFLY
DESCRIBE THE DATA, SCIENTIFIC
DATA THAT WILL BE MANAGED AND OF
THOSE DATA THAT WILL BE MANAGED,
WHICH OF THEM WILL BE SHARED,
AND ANY RATIONALE FOR WHY NOT
ALL THE DATA WILL BE SHARED.
THE RESEARCHERS ELEMENT TWO
SHOULD DESCRIBE TOOLS, SOFTWARE
AND/OR CODE SPECIFICALLY THAT
ARE NEEDED TO ACCESS OR
MANIPULATE SHARED SCIENTIFIC
DATA TO SUPPORT REPLICATION OR
RE-USE.
ELEMENT THREE IS STANDARDS.
WHICH STANDARDS WILL BE APPLIED
TO THE SCIENTIFIC DATA AND
ASSOCIATED METADATA IF THEY
EXIST.
ELEMENT 4 ON DATA PRESERVATION
ACCESS AND ASSOCIATED TIME
LINES, THIS IS WHERE RESEARCHERS
SHOULD NAME THE REPOSITORY OR
DATA REPOSITORIES WHERE DATA
WILL BE SHARED.
THEY SHOULD INDICATE HOW THE
SCIENTIFIC DATA WILL BE FINDABLE
BY THE BROAD RESCHER COMMUNITY,
AND WHEN THE SCIENTIFIC DATA
WILL BE MADE AVAILABLE FOR
OTHERS TO USE AND FOR OH HOW HO.
ELEMENT FIVE IS MORE SPECIFIC TO
RESEARCHERS WHO ARE WORKING WITH
HUMAN DATA.
AND THIS IS ACCESS DISTRIBUTION
OR RE-USE CONSIDERATIONS.
IN THIS ELEMENT, RESEARCHERS
SHOULD DESCRIBE APPLICABLE
FACTORS THAT MIGHT EFFECT
SUBSEQUENT ACCESS, DISTRIBUTION
OR RE-USE OF SCIENTIFIC DATA.
THIS COULD BE, FOR EXAMPLE,
LIMITATIONS IMPOSED BY INFORMED
CONSENT POLICIES OR OTHER
REGULATIONS.
ALSO IN THIS ELEMENT,
RESEARCHERS SHOULD DESCRIBE HOW
THEY WILL EMPLOY PRIVACY
PROTECTIONS WHEN SHARING HUMAN
DATA.
AND THIS COULD INCLUDE BUT IT'S
NOT LIMITED TO DEIDENTIFICATION
PROTOCOLS, CERTIFICATED OF
CONFIDENTIALITY, AND SHARING
WITH ACCESS CONTROLS.
FINALLY, ELEMENT SIX IS
OVERSIGHT OF DATA MANAGEMENT AND
SHARING, AND IN THIS ELEMENT,
RESEARCHERS SHOULD DESCRIBE HOW
COMPLIANCE WITH THE PLAN WILL BE
MONITORED AND MANAGED, THE
FREQUENCY OF OVERSIGHT AND BY
WHO.
RESEARCHERS ARE EXPECTED TO
BUDGET FOR DATA MANAGEMENT AND
SHARING COSTS.
IN ANOTHER GUIDE NOTICE
PUBLISHED BY THE OFFICE OF
SCIENCE POLICY, THE
IMPLEMENTATION DETAILS ARE
DESCRIBED AS WELL AS ALLOWABLE
COSTS.
THE COSTS THAT ARE REQUESTED,
DIRECT COSTS, SHOULD BE INCLUDED
IN THE BUDGET FORM AND THEY
SHOULD BE INDICATED AS DAW TA
MANAGEMENT SHARING COSTS.
IN THE BUDGET JUSTIFICATION OF
AN APPLICATION, RESEARCHERS
SHOULD WRITE UP A BRIEF SUMMARY
OF THEIR DMS PLAN AND A
DESCRIPTION OF THE COST THEY ARE
REQUESTING BY CATEGORY OF
ALLOWABLE COSTS.
AND THERE ARE THREE CATEGORIES
OF ALLOWABLE COSTS.
THE FIRST IS CURATING DATA AND
DEVELOPING THE SUPPORTING
DOCUMENTATION.
THIS IS MOST COMMON AND IT
USUALLY BEARS OUT AS PERSONNEL
COSTS.
THE OTHER TWO ALLOWABLE COST
CATEGORIES ARE LESS COMMON.
THESE ARE PRESERVING AND SHARING
DATA THROUGH REPOSITORIES, AND
UNIQUE SPECIAL LOCAL DATA
MANAGEMENT COSTS.
AND A KEY POINT HERE IS ALL
COSTS PROPOSED FOR DATA
MANAGEMENT AND SHARING IN AN
APPLICATION MUST BE INCURRED
DURING THE PERFORMANCE PERIOD.
THE GUIDE NOTICE DOES OUTLINE
UNALLOWABLE COSTS AS WELL.
YOU CANNOT CHARGE INFRASTRUCTURE
COSTS THAT ARE TYPICALLY
INDIRECTS OR F & A AND COSTS
ASSOCIATED WITH THE ROUTINE
CONDUCT OF RESEARCH, COSTS FOR
GAINING ACCESS TO O RESEARCH DAA
ARE UNALLOWABLE COSTS.
THIS IS SPECIFIC TO EXTRAMURAL.
SO THE IMPLEMENTATION OF THE
POLICY IS BEST VISUALIZED IF YOU
FOLLOW THE LIFECYCLE OF THE
PLAN.
AND I'LL START WITH SUBMISSION
OF A PLAN.
IT GOES IN WITH AN APPLICATION
AS DESCRIBED IN THE APPLICATION
DWIED, GUIDE, THE FULL PLAN IS
SUBMITTED, AND THE BRIEF PLAN
DESCRIPTION AS I JUST MENTIONED
IS INCLUDED IN THE BUDGET JUST
JUSTIFICATION.
AFTER A PLAN IS SUBMITTED, IN
THE PLAN ASSESSMENT PHASE, PEER
REVIEWERS WILL NOT SEE THE DATA
MANAGEMENT AND SHARING PLAN.
WHAT THEY WILL SEE IS THE BUDGET
AND THE BUDGET JUSTIFICATION,
AND THEY CAN COMMENT ON THAT BUT
THEY WILL NOT SCORE IT.
ONLY THE NIH PROGRAM OFFICER
WILL SEE AND ASSESS THAT PLAN.
IF A PROGRAM OFFICER DETERMINES
THAT REVISIONS ARE NEEDED, THEY
CAN REQUEST REVISIONS DURING THE
REGULAR JUST IN TIME PROCESS,
PLANS MUST BE APPROVED BEFORE AN
AWARD IS MADE.
THERE IS A PATH WHERE PEER
REVIEWERS CAN REVIEW AND SCORE
PLANS AND THIS IS ONLY WHEN DATA
SHARING IS DETERMINED BY NIH TO
BE INTEGRAL TO THE FUNDING
OPPORTUNITY ANNOUNCEMENT.
FINALLY, WHEN A PLAN IS APPROVED
FOR AN EXTRAMURAL APPLICATION,
AND THE AWARD IS MADE, THAT
BECOME AS TERM AND CONDITION OF
THE AWARD, AND THEN THE GRANTEE
IS EXPECTED TO REPORT ON
PROGRESS OF THEIR DATA
MANAGEMENT AND SHARING
ACTIVITIES THROUGH THE RPPR
PROGRESS.
FAILURE TO COMPLY WITH THE
APPROVED PLAN MAY RESULT IN AN
ENFORCEMENT ACTION AND COULD
AFFECT FUTURE FUNDING DECISIONS.
FOR THE LAST SECTION OF TODAY'S
PRESENTATION, I'LL TALK ABOUT
THE DATA SHARING RESOURCES THAT
WE ARE DEVELOPING FOR OUR STAFF
AND INVESTIGATORS.
I'LL START WITH THE RESOURCES
THAT WE ARE DEVELOPING FOR STAFF
AND RESEARCHERS, SPECIFICALLY TO
SUPPORT READINESS FOR COMPLIANCE
WITH THE DATA MANAGEMENT AND
SHARING POLICY.
OUR GOALS IN DEVELOPING THESE
RESOURCES WHICH AS I MENTIONED
ARE DIRECTLY INFORMED BY ADVICE
FROM OUR ADVISORY COMMITTEES IS
TO PREPARE OUR STAFF TO FIELD
QUESTIONS FROM RESEARCHERS AND
TO REVIEW DATA MANAGEMENT AND
SHARING PLANS, AND TO SUPPORT
OUR EXTRAMURAL AND INTRAMURAL
RESEARCHERS AS THEY DEVELOP DATA
MANAGEMENT AND SHARING PLANS.
WE HAVE A NUMBER OF RESOURCES
AND CURATED LINKS TO OTHER
RESOURCES ON OUR WEBSITE.
THIS IS ON THE PUBLIC NICHD
WEBSITE AND THE LINK IS BELOW.
THIS INCLUDES BUT IS NOT LIMITED
TO TIPS FOR WRITING A DATA
MANAGEMENT AND SHARING PLAN.
I HIGHLY ENCOURAGE YOU HAVE A
LOOK AT THAT DOCUMENT.
WE ALSO HAVE SEVERAL EXAMPLE
DATA MANAGEMENT AND SHARING
PLANS AVAILABLE ON OUR WEBSITE,
AND THIS WEEK WE WILL BE
RELEASING A DATA REPOSITORY
FINDER WEB TOOL, WHICH WILL HELP
RESEARCHERS TO DEVELOP OUT THEIR
PLANS BECAUSE THE TOOL SPECIFIES
FEATURES ASSOCIATED WITH DATA
REPOSITORIES THAT MAP TO THE
ELEMENTS EXPECTED IN DATA
MANAGEMENT AND SHARING PLANS.
INTERNALLY, WE HAVE DEVELOPED
AND CONTINUE TO DEVELOP
EXTENSIVE FREQUENTLY ASKED
QUESTIONS FOR OUR INTRAMURAL AND
EXTRAMURAL STAFF, AND FOR OUR
EXTRAMURAL STAFF, WE HAVE
DEVELOPED PLAN ASSESSMENT
GUIDANCE TO SUPPORT CONSISTENCY
IN DATA MANAGEMENT AND SHARING
PLAN ASSESSMENT ACROSS THE
INSTITUTE.
WE RECOGNIZE WHILE THESE DATA
MANAGEMENT AND SHARING POLICY
IMPLEMENTATION RESOURCES ARE
FOCUSED ON READINESS FOR
COMPLYING WITH THE POLICY, WE
ALSO NEED TO FOCUS ON THE
LONGER-TERM NEED FOR THE DATA
ECOSYSTEM WHERE RESEARCHERS CAN
SHARE DATA DESCRIBED IN THEIR
PLANS AND SO THAT THE RESEARCH
COMMUNITY CAN ULTIMATELY FIND,
ACCESS AND USE THOSE DATA FOR
THE FURTHERANCE OF OUR VISION
AND THE NICHD MISSION.
SO THIS SLIDE OUTLINES OUR NICHD
DATA ECOSYSTEM STRATEGY.
WE ARE LEVERAGING OUR
OPPORTUNITIES.
WE HAVE THREE BIG OPPORTUNITIES
OUTLINED HERE.
THE POLICY IS GOING TO VASTLY
INCREASE TH THE SCALE AND SCOPE
AVAILABLE FOR RESPONSIBLE AND
INNOVATIVE USE.
THEY COORDINATE THE DEVELOPMENT
OF TRANS-NIH ECOSYSTEM
RESOURCES, INCLUDING
REPOSITORIES, TOOLS, STANDARDS
AND TRAININGS.
AND WE CAN LEVERAGE THOSE FOR
OUR OWN NEEDS BY INFORMING THEIR
DEVELOPMENT AT THE OUTSET.
WE ALSO AT NICHD HAVE A NUMBER
OF EXISTING INVESTMENTS IN
MODERN DATA SHARING
INFRASTRUCTURE, AND BOTH I AND
VALERIE COTTON SERVE LEADERSHIP
ROLES IN THE INTEROPERABILITY
ACTIVITIES, SPECIFICALLY THE NIH
CLUB PLATFORMS FOR
INTEROPERABILITY ACTIVITY AND
THE NIH RESEARCHER OFF SERVICE,
WHICH I'LL MENTION IN A MINUTE.
OUR STRATEGY IS TO LEVERAGE
THESE OPPORTUNITIES, BUT ALSO TO
FOCUS ON ADDRESSING KEY
CHALLENGES AND NEEDS AROUND DATA
SCIENCE AND SHARING.
A CHALLENGE THAT WE ARE
ATTRACTING IS THAT NIH RELEVANT
DATA ARE AND WILL BE SHARED IN
MANY DIVERSE NIH DATA SYSTEMS.
WE RECOGNIZE THAT NIH NEEDS
INCREASED VISIBILITY INTO THE
CURRENT STATE OF THESE DATA
SYSTEMS AND HOW OUR DIVERSE NIH
COMMUNITIES USE OR ASPIRE TO USE
THE SYSTEMS AND THEIR DATA.
WE ALSO RECOGNIZE THAT
DEMOCRATIZING ACCESS TO THE
NICHD DATA SYSTEM -- ECOSYSTEM
REQUIRES ACTIVE ENGAGEMENT WITH
AND TRAINING OF DIVERSE
RESEARCHERS, DEVELOPERS AND
OTHER COMMUNITY MEMBERS.
THE NIH DATA AND SPECIMEN HUB IS
ONE OF THOSE MAJOR INVESTMENTS
IN MODERN DATA SHARING
INFRASTRUCTURE.
IT'S A CENTRALIZED RESOURCE FOR
OUR CLINICAL RESEARCHERS,
INTRAMURAL AND EXTRAMURAL, TO
SHARE DE-IDENTIFIED DATA AND
CLINICAL STUDIES FUNDED BY
NICHD.
IT IS A PORTAL BOTH FOR
SEARCHING DATA AND FOR
REQUESTING ACCESS TO
BIOSPECIMENS ASSOCIATED WITH
SELECTED STUDIES IN DASH AND
ULTIMATELY DASH MEA AIMS TO
ACCELERATE SCIENTIFIC FINDINGS
TO ULTIMATELY IMPROVE HUMAN
HEALTH.
DASH WAS CONCEPTUALIZED IN 2015
AS A COLLABORATION WITH THE
DIVISION OF EXTRAMURAL RESEARCH
AND OUR CIO.
WE CURRENTLY HOST DATA FROM OVER
200 NIH-FUNDED CLINICAL STUDIES
SPREAD ACROSS 54 STUDY TOPICS
DISPLAYED IN THE TOP RIGHT OF
THE SLIDE.
WE FIELDED ALSO 600 ACCESS
REQUESTS FOR THOSE DATA IN THE
LAST FIVE YEARS, OF WHICH OVER
83 HAVE RESULTED IN
PUBLICATIONS.
CURRENTLY THERE ARE NINE STUDIES
IN DASH THAT OFFER BIOSPECIMENS
THROUGH THE BIOSPECIMEN ACCESS
REQUEST, AND WE FIELDED 12
ACCESS REQUESTS.
AS I MENTIONED, THIS NUMBER IS
GOING TO INCREASE SUBSTANTIALLY
AS WE HAVE MORE AND MORE DATA
BEING SHARED UNDER THE POLICY.
NICHD DASH IS AN NICHD-WIDE
CLINICAL DATA REPOSITORY, AND
THE PROGRAM MOVED INTO OUR
OFFICE LAST YEAR.
SINCE THEN, WE HAVE RELEASED
SEVERAL NEW DATA MANAGEMENT AND
SHARING POLICY-SPECIFIC
FEATURES.
WE ARE INTEGRATED WITH THE
RESEARCHER OFF SERVICE.
THAT SUPPORTS SINGLE SIGN-ON SO
RESEARCHERS WHO WANT TO ACCESS
STUDY DATA THAT ARE SHARED IN
DASH AND IN OTHER NIH DATA
REPOSITORIES CAN DO SO EASILY.
WE ARE ASSIGNING DIGITAL --
IDENTIFIERS TO OUR STUDIES TO
HELP RESEARCHERS ADDRESS
EXPECTED ELEMENTS AND ALSO
SUPPORTS FINDABILITY AND DATA
USE CITATION OVER TIME, SO WE
CAN EVALUATE OUTCOMES OF DATA
SHARING.
WE HAVE UPDATED OUR EXTERNAL
RESOURCES WEBPAGE AS A PROTOTYPE
FOR A FUTURE DASH CAT LOI FOR
SEARCHING ALL NICHD FUNDED DATA
ASSETS AND WE RECENTLY SIGNED A
MODERNIZATION CONTRACT FOR DASH,
WHERE WE WILL BE DEVELOPING OVER
THE NEXT FEW YEARS ADDITIONAL
DATA MANAGEMENT AND SHARING
POLICY-SPECIFIC FEATURES.
THESE INCLUDE BUT ARE NOT
LIMITED TO A FOUR-MONTH
SUBMISSION TO RELEASE TIMELINE
FOR DATA.
THAT REQUIRES US TO UPDATE OUR
PROCESSES AND TECHNOLOGIES
AROUND SUBMISSION, CURATION
AND -- AND IT INCLUDES THE
ABILITY TO RELEASE VERSION, DATA
AND PUBLICATION-RELATED DATA
RELEASES IN COMPLIANCE WITH THE
POLICY.
WE ARE WORKING ON SENDING
AUTOMATED STUDY REGISTRATION.
WE ARE DEVELOPING COMPLIANCE
TRACKING RESOURCES FOR OUR
STAFF, AND WE ARE WORKING WITH
OUR INTRAMURAL STAFF TO
STREAMLINE THE SUBMISSION OF
INTRAMURAL DATA FROM OUR
INTERNAL DATA MANAGEMENT SYSTEM
TO DASH.
IN ORDER TO INCREASE VISIBILITY
INTO THE DATA SYSTEMS USED BY
OUR RESEARCHERS AND THE WAY THEY
DEAL AND AS SPIRE TO WORK WITHIN
THESE SYSTEMS WE ESTABLISHED A
DATA ECOSYSTEM ANALYSIS WITH GUY
CGUIDANCE FROM OUR ECOSYSTEM
WORKING GROUP.
DASH WILL BE A CENTRAL COMPONENT
IN THE ECOSYSTEM BOTH FOR
STORING CLINICAL DATA AND
FACILITATING RESEARCH ACROSS THE
MANY SYSTEMS WHERE OUR DATA AND
RELEVANT DATA LIVE.
WE HAVE TWO PARALLEL ACTIVITIES
UNDER THE ECOSYSTEM ANALYSIS.
WE ARE ACTIVELY -- WELL, FIRST
OUR ECOSYSTEM WORKING GROUP
DEVELOPED AN INVENTORY OF DATA
REPOSITORIES WHERE OUR
RESEARCHERS CURRENTLY SHARE AND
ACCESS DATA.
WE ARE NOW ASSESSING THOSE NICHD
RELEVANT DATA ECO -- DATA
SYSTEMS.
AND THE SYSTEM LOGOS ON THE
RIGHT ARE JUST A SUBSET OF THAT
INVENTORY, AND THEY DEMONSTRATE
THE BREADTH OF RESEARCH AND DATA
TYPES IN THESE SYSTEMS.
IN PARALLEL, THE ECOSYSTEM
ANALYSIS PROJECT TEAM IS
DEVELOPING USE CASES FROM OUR
RESEARCHERS, STAFF AND BROADER
COMMUNITY MEMBERS.
TOGETHER, THE ASSESSMENT OF THE
DATA SYSTEMS AND THE USE CASES
WILL INFORM THE IDENTIFICATION
OF DATA REPOSITORIES THAT DO OR
CAN MEET AN NICHD THRESHOLD FOR
LONG-TERM DATA SHARING.
THEY WILL ALSO INFORM THE
IDENTIFICATION OF AN NICHD
APPROACH TO BUILDING CONNECTIONS
BETWEEN DASH AND OTHER NICHD,
NIH, AND EXTERNAL SYSTEMS, IN
THE SPIRIT OF INTEROPERABILITY
AND LEVERAGING EXISTING
INVESTMENTS.
FINALLY, IN RECOGNITION OF THE
NEED TO SUPPORT EQUITABLE ACCESS
TO OUR NICHD DATA ECOSYSTEM, OUR
NICHD DATA SCHOLAR HAS DEVELOPED
A HYBRID COURSE CALLED THE
ELEMENTS OF STYLE IN WORKFLOW
CREATION AND MAINTENANCE.
THIS TRAINING TEACHES
RESEARCHERS BEST PRACTICES IN
MANAGING AND ANALYZING
NICHD-RELEVANT DATA USING
EXISTING TOOLS AND PLATFORMS AND
DATA, AND THEN HELPS THEM TO
SHARE THEIR ANALYSIS WORKFLOWS
FROM OTHER RESEARCHERS FOR
RE-USE.
THE AUDIENCE -- THIS IS A
RESEARCHER-FOCUSED TRAINING.
IT'S TARGETED TO RESEARCHES WITH
LIMITED DATA SCIENCE SKILLS AND
UTILIZES TWO NICHD-LED TRANS-NIH
DATA INFRASTRUCTURES.
THE INCLUDE DATA HUB FOR
PARTICIPANTS WITH DOWN'S
SYNDROME AND THE FIRST KIDS DATA
RESOURCE CENTER, CANCER AND
STRUCTURAL BIRTH DEFECTS.
DR. MAYS HAS ALREADY TAUGHT FOUR
TIMES AND MATERIALS ARE
AVAILABLE ONLINE FOR SELF YOU
HAD STUDY IN OUR ONLINE
REPOSITORY GITHUB.
DR. MAYS WILL CONTINUE TO TRAIN
MORE RESEARCHES I IN 2023 AT LAE
MEETINGS.
I WILL CLOSE OUT TODAY WITH THIS
GRAPHIC TO EMPHASIZE WE ARE
BUILDING A COMMUNITY-FOCUSED
ECOSYSTEM THAT ALIGNS WITH THE
NICHD MISSION.
AND I WANT TO THANK YOU, THE
ADVISORY COUNCIL, AND DRS.
BIANCHI AND CERNICH FOR THEIR
SUPPORT AND GUIDANCE IN THE
ESTABLISHMENT OF THE OFFICE OF
DATA SCIENCE AND SHARING.
THANK YOU VERY MUCH.
>> THANK YOU SO MUCH, REBECCA.
THAT WAS FANTASTIC AND SO
TIMELY, AND WE HAVE TIME -- WE
ALLOTTED ABOUT 15 MINUTES FOR
QUESTIONS.
SO WE'RE OPENING THIS UP TO
COUNCILMEMBERS.
DR. RESNICK.
>> I WANT TO FIRST START WITH,
REALLY, RECOGNITION, THE
LEADERSHIP ROLE NICHD IS TAKING,
YOU KNOW, IN DEVELOPING THESE
STRATEGIES.
WE WORK ACROSS MULTIPLE
DIFFERENT INSTITUTES AND CENTERS
ACROSS NIH, I THINK -- AND
ACROSS MULTIPLE CONSORTIA-BASED
INSTITUTIONS.
I THINK THERE'S BEEN A LOT OF
ANXIETY AND CONFUSION AROUND THE
DATA SHARING MANAGEMENT PLAN,
WHAT IT MEANS TO ADDRESS IT.
AND I THINK AS A CONTEXT OF
PROVIDING THE EXACT RIGHT
BALANCE BETWEEN THE VERY CLEAR
GUIDANCE BUT AT THE SAME TIME
LEADING ON BEHALF OF DEVELOPING
ACCELERATED FRAMEWORKS FOR DIE A
SHADATASHARING FROM AN ECOSYSTEM
PERSPECTIVE.
I ALSO WANT TO RECOGNIZE, GIVEN
ALL THAT WORK, I SUSPECT THAT
THERE ARE GOING TO BE CONTINUED
CHALLENGES AND OPPORTUNITIES FOR
IMPROVEMENT.
REBECCA, YOU MENTIONED BRIEFLY
THREE KEY
OPPORTUNITIES/CHALLENGES THAT
YOU SEE IN THE FUTURE.
ONE THING WE'VE NOTICED IS THAT
WHILE NICHD IS REALLY DOING A
GREAT JOB LEADING -- PROVIDING
THESE RESOURCES, THERE'S NOT YET
UNIFORMITY OF INTERPRETATION OF
THE DATA SHARING GUIDELINES
ACROSS THE DIFFERENT ICs AND
HOW THEY GET IMPLEMENTED.
WHAT ARE YOUR THOUGHTS -- AT
LEAST THAT'S MY ASSESSMENT.
WE'D LOVE TO HEAR YOURS.
WHAT ARE YOUR THOUGHTS AROUND
WAYS THAT, YOU KNOW, YOU CAN
TACKLE THAT AND/OR ADDRESS THAT?
I THINK, AGAIN, DRIVING FORWARD
WITH DOCUMENTATION AND
LEADERSHIP AS A KEY ONE, BUT
WONDERING WHAT YOU'VE ASSESSED.
>> AND YOU HIT ON THE FIRST
POINT, AND THAT'S A GREAT
QUESTION, ADAM.
SO CONSISTENCY IN IMPLEMENTATION
OF THE POLICY.
IT'S AN IMPORTANT QUESTION.
IT'S KIND OF A TWO-PRONG ANSWER
HERE.
FIRST WE ARE FOCUSED ON THE WORD
OF THE POLICY AND IMPLEMENTING
IT AS SUCH.
WE DID DECIDE WITH OUR DATA
SHARING COMMITTEES THAT WAS OUR
STRATEGY.
WE WANT -- THE POLICY IS REALLY
WELL WRITTEN AND EXTENSIVE
ENOUGH, SO WE'RE NOT ADDING ANY
ADDITIONAL REQUIREMENTS HERE.
ALL WE ARE DOING IS TAKING THE
WORD OF THE POLICY, INTERFACING
REGULARLY WITH THE OFFICE OF
EXTRAMURAL RESEARCH AND THE
OFFICE OF SCIENCE POLICY TO TURN
IT INTO PLAIN LANGUAGE RESOURCES
THAT ARE POSTED ON OUR WEBSITE
AND SHARED WITH OUR COLLEAGUES
AT OTHER ICs AND ALSO
INTERNALLY IN OUR FAQs.
WE ALSO PARTICIPATE IN
TRANS-NIH -- THERE'S A WORKING
GROUP ON DATA MANAGEMENT AND
SHARING POLICY IMPLEMENTATION
AND GOVERNANCE, AND WE HAVE BEEN
A PART OF THAT SINCE DAY ONE AND
WE WILL CONTINUE TO DO THAT SO
WE COLLABORATE EXTENSIVELY WITH
OUR IC COUNTERPARTS TO ENSURE WE
ARE MAINTAINING AS MUCH
CONSISTENCY AS POSSIBLE IN THE
IMPLEMENTATION.
>> GREAT.
AND AGAIN, KUDOS TO THE TEAM.
I KNOW THIS IS REALLY HARD WORK
AND TAKES A LOT OF COORDINATED
EFFORT.
SO REALLY EXCITED.
>> DR. BARKIN.
>> GOOD AFTERNOON, EVERYBODY.
THANK YOU.
THIS IS REALLY AN EXCITING
DIRECTION, AND I ABSOLUTELY ECHO
DR. RESNICK'S COMMENTS THAT
YOU'RE TAKING US IN A REALLY
IMPORTANT DIRECTION AND YOU'RE
THINKING ABOUT IT IN SUCH A
SYSTEMATIC HOLISTIC WAY, SO
THANK YOU TO YOU AND THE TEAM.
I HAVE TWO QUESTIONS FOR YOU.
RECOGNIZING THAT MANY PEOPLE AS
THEY'RE GATHERING DATA HAVE ALL
THESE DIFFERENT DATA ELEMENT
TYPES AS YOU SAID, IT APPEARS
THAT WHEN I LOOK AT ALL THE
DIFFERENT NICHD REPOSITORIES,
THAT WE WOULD HAVE TO
POTENTIALLY SORT OF DECONSTRUCT
OUR DATA SO THAT THESE ELEMENTS
OF THE DATA GO TO THIS
REPOSITORY, AND OTHER ELEMENTS
GO TO ANOTHER, SO THE SURVEYS
MIGHT GO TO THIS PART, THE
BIOSPECIMENS MIGHT GO TO THIS
PART.
AND I'M WONDERING ABOUT THAT IN
THE DECONSTRUCTING, IT MIGHT BE
DIFFICULT TO GET BACK TO THAT
REPLICATION OF FINDINGS.
SO THAT'S MY FIRST QUESTION.
MY SECOND QUESTION HAS TO DO
WITH IF THERE ARE BY OWE
SPECIBUY YOESPECIMENS, WHAT IT O
SEND OUR SPECIMENS TO THE
BIOREPOSITORY AND THAT IN THE
DASH REPOSITORY, THEY WOULD
STORE, FOR EXAMPLE, OUR
SPECIMENS AT A MINUS 80 FREEZER.
SO CAN YOU CLARIFY THOSE THINGS
FOR ME?
>> SURE.
ABSOLUTELY.
AND THANK YOU, DR. BARKIN.
I APPRECIATE EVERYBODY'S REALLY
POSITIVE COMMENTS.
SO THE DECONSTRUCTING OF THE
DATA, THIS IS THE NATURE OF THE
NIH DATA ECOSYSTEM.
OUR DATA REPOSITORIES ARE DOMAIN
AND DATA TYPE-SPECIFIC, AND THEY
ARE THAT WAY FOR A REASON.
IT BECAUSE IT ALLOWS US TO CARE
AND FEED FOR THE DATA IN A WAY
THAT'S BEST INFORMED BY THE
RESEARCH COMMUNITY THAT
UNDERSTANDS EITHER THE DOMAIN OR
THE DATA TYPE.
BUT BY NATURE, THAT MEANS WE
KNOW THE RESEARCH WE DO INVOLVES
MANY DIFFERENT DATA TYPES, AND
SO IT ENDS UP SPLITTING UP THE
TTHEDATA INTO DIFFERENT
REPOSITORIES.
THERE ARE WAYS TO CONNECT THE
DATA, YOU MAINTAIN THE INTEGRITY
OF THE DATA IN THE GIVEN DATA
REPOSITORY, AND WHAT WE INTEND
DO IS TO ALLOW RESEARCHERS TO
KNOW WHEN THERE ARE ADATA FROM A
GIVEN STUDY IN THE DATA
REPOSITORIES.
THAT'S SOMETHING WE ALREADY DO
IN DASH, WE LINK OUT TO THE
DBGAP ACCESS NUMBERS, IF THERE
ARE GENOMICS DATA, AND THERE'S
CLINICAL DATA FOR A GIVEN STUDY
IN DASH, WE DO THAT.
THE IMPLEMENTATION OF DIGITAL
OBJECT IDENTIFIERS WILL ALLOW US
TO PERMANENTLY NEST THAT
INFORMATION IN THOSE DOIs SO
THAT'S SOMETHING WE ARE THINKING
ABOUT AND OTHER IC INSTITUTES
ARE ALREADY DOING THE SAME
THING.
SO I DON'T SEE ALL OF THE DATA
COMING TOGETHER.
IT MORE ABOUT MAKING SURE THAT
THERE ARE PERMANENT REFERENCES
TO ALL OF THE DIFFERENT PLACES
WHERE THOSE DATA LEFT UNDER A
GIVEN STUDY.
THE SECOND QUESTION ABOUT
BIOSPECIMENS, THAT IS NOT
INCLUDED IN THE POLICY.
THE POLICY IS VERY SPECIFIC TO
DATA MANAGEMENT AND SHARING, AND
THE COSTS ASSOCIATED WITH DATA
MANAGEMENT AND SHARING.
SO BIOSPECIMENS AT THIS POINT
ARE STILL COVERED UNDER RESOURCE
SHARING PLANS, AND ANY
EXPECTATIONS OF BIOSPECIMEN
SHARING WOULD LIKELY BE PART OF
A PROGRAM ANNOUNCEMENT.
>> OKAY.
AND THEN MY LAST POINT THAT I
JUST WANTED TO THROW OUT IS THAT
I KNOW THAT ALL OF US USES THE
DATA RESOURCE CENTER THAT'S ALL
ABOUT CURATING DATA,
SYNTHESIZING DATA AND THEN
CREATING A RESEARCHER WORK
BADGE.
IT SEEMS LIKE WHAT YOU JUST
DESCRIBED SOUNDS PRETTY SIMILAR
EXCEPT THAT THERE IS THE
POTENTIAL TO TAKE CALL OF THE
DATA, AS YOU SHOWED US IN THE
ECOSYSTEM, AND BRING THEM INTO
ONE CENTRALIZED PLACE, SO THAT
WHEN PEOPLE ARE THEN LOOKING TO
ASK QUESTIONS OF THE DATA, THEY
HAVE ACCESS TO MORE CURATED
DATA.
I JUST WAS CURIOUS IF YOU LOOKED
INTO THAT AS A MODEL.
>> WE HAVE NOT LOOKED INTO THE
MODEL OF INTEGRATING DATA FROM
EXISTING REPOSITORIES INTO ONE.
THAT FEELS A BIT OUT OF SCOPE
FOR WHAT WE'RE DOING AT THIS
POINT.
IT'S JUST A MASSIVE CHALLENGE,
AND I THINK IT REALLY DEPENDS IF
WE SEE THERE ARE SPECIFIC USE
CASES WHERE THERE ARE HIGH
PRIORITY DATASETS THAT NEED THIS
TYPE OF CURE RANGE OF MOTION AND
INTEGRATION, BUT AT THIS POINT,
THAT'S GENERALLY NOT HOW WE
APPROACH IT, RATHER, WHAT WE DO
IS MAKE SURE RESEARCHERS KNOW
WHERE TO GET ALL THE
PIECES/PARTS OF DATA FOR A GIVEN
STUDY AND HAVE SUFFICIENT
DOCUMENTATION TO UNDERSTAND HOW
TO APPROPRIATELY USE AND ANALYZE
THOSE DATA.
>> COULD I ADD SOMETHING,
REBECCA?
YOU KNOW, NOW THAT A LOT OF
PEOPLE ARE HAVING IN-PERSON
MEETINGS, I'M GOING BACK TO
VARIOUS ACADEMIC CENTERS, AND
I'M ALWAYS SURPRISED HOW FEW
ORGANIZATIONS EVEN KNOW ABOUT
DASH.
SO I'M GOING TO MAKE A REQUEST
TO ALL OF OUR COUNCILMEMBERS TO
SERVE AS AMBASSADORS FOR DASH.
THIS IS AN INCREDIBLE RESOURCE,
PARTICULARLY FOR TRAINEES.
IN WHICH THEY CAN DEVELOP A
HYPOTHESIS AND TEST IT VIRTUALLY
IMMEDIATELY, THEY DON'T HAVE TO
WORRY ABOUT GETTING AN IRB
PROTOCOL APPROVED, THEY DON'T
HAVE TO WORRY ABOUT ENROLLING
PARTICIPANTS OR GETTING
BIOSPECIMENS.
THEY CAN DEVELOP THEIR
HYPOTHESIS, REQUEST THE CLINICAL
DATA, WHICH IS ALREADY CLEANED
UP AND ANONYMIZED AND READY FOR
USE, AND THEN THEY CAN REQUEST
THE BIOSPECIMENS.
SO I THINK THERE'S -- WE NEED TO
WORK ON WAYS OF DEMYSTIFYING IT
FOR ALL OF OUR POTENTIAL
INVESTIGATORS.
SO THAT THEY DO KNOW WHERE IT IS
AND HOW THEY CAN ACCESS IT.
LET'S GO TO DR. ROWITCH.
>> GREAT INITIATIVE, GLAD TO SEE
NICHD'S LEADERSHIP HERE.
MY QUESTION IS ABOUT METADATA,
WHICH YOU MENTIONED, REBECCA, IN
RESPECT TO HUMAN CELL ATLASSING.
THIS IS AN INTERNATIONAL EFFORT
NOW STARTING TO PROGRESS TO
PEDIATRIC STUDIES LED BY THE
ZUCKERBERG INITIATIVE.
ONE OF THE BOTTLENECKS I'VE
HEARD ON THESE CALLS IS, HOW
MUCH AND WHAT METADATA IS
ACCEPTABLE AND SHOULD WE BE
ASCERTAINING SO THAT STUDIES ARE
COMPARABLE, WE CAN START TO MAKE
BRIDGES TO HUMAN IMPACT AND
DISEASE INSIGHTS FROM MORE SORT
OF DEVELOPMENTAL BIOLOGY
APPROACH OR PATHOLOGICAL
APPROACH TO ATLASSING, AND THAT
THE STANDARDS AREN'T THERE.
SO IF NIH IS SETTING STANDARDS,
AND THEY WILL BE REQUIRED ON OUR
NIH GRANTS, IT SEEMS LIKE A
GREAT OPPORTUNITY TO NOW WORK
WITH THE FOUNDATIONS LIKE ALLEN
INSTITUTE, THE BRAIN INITIATIVE,
ZUCKERBERG, AND COME UP WITH THE
STANDARD METADATA SET THAT I
THINK WILL REALLY HELP TO MAKE
MORE COHERENT THESE MULTIPLE
EFFORTS.
I'M SURE YOU'VE BEEN THINKING
ABOUT THAT AND I DO THINK IT'S A
GREAT OPPORTUNITY IF NIH TAKES
THE LEAD.
>> IT'S A GREAT QUESTION.
I'LL TRY TO TEASE THAT APART.
NIH DOES NOT GENERALLY REQUIRE
STAN DARMDZ BROADLY.
SPECIFIC PROGRAMS MAY.
I EXPECT STANDARDS TO BE USED
FOR BOTH METADATA AND DATA BUT
WE DON'T GENERALLY PICK DATA
STANDARDS SO I DO WANT TO
CLARIFY THAT.
YOU POINT OUT THE HUMAN CELL
ATLAS WITH ZUCKERBERG AND THE
BRAIN INITIATIVE.
THIS IS EXACTLY AN EXAMPLE OF
THE COMMUNITY COMING TOGETHER
WITH EXPERTS ON THE DATA AND HOW
IT CAN BE USED FOR ANALYSIS.
THOSE ARE THE RESEARCHERS THAT
WE LOOK TO AS EXPERTS TO DEVELOP
OUT THE METADATA STANDARD AND
REQUIRED ELEMENTS IN THAT DATA
NECESSARY TO REPRODUCE FINDINGS
AND MERGE DATASETS OVER TIME.
SO I WOULD LOOK TO THE
REPOSITORIES TO DEVELOP THIS
OUT.
I DO AGREE THAT THIS IS WHAT WE
WANT TO WATCH.
I MENTIONED OUR STANDARDS
TRAININGS AND PARTNERSHIPS
ACTIVITY.
THIS IS THE KIND OF PLACE WHERE
WE WOULD ENGAGE WITH THE
COMMUNITY, WORKING IN THE
REPOSITORY SPACE TO LEARN ABOUT
THE METADATA STANDARDS THEY ARE
DEVELOPING AND THEN TO
DISSEMINATE THAT INFORMATION
MORE BROADLY FROM THE PLATFORMS
OUR OFFICE HAS.
>> THAT'S GREAT.
JUST TO ADD, I THINK THERE WILL
BE A WORKSHOP TO DEAL WITH THIS,
AND IT SEEMS LIKE A GREAT
OPPORTUNITY FOR NICHD TO BE AT
THE TABLE.
>> THAT'S A GREAT IDEA.
THANK YOU, DR. ROWITCH.
>> THANK YOU.
DR. FAIR.
>> HELLO.
YES.
SO IT SOUNDS LIKE YOU'RE BUSY,
REBECCA.
A LOT GOING ON.
MY QUESTION IS, AS YOU KNOW,
WE'VE KIND OF BEEN AT THIS WHOLE
REPOSITORY AND THINKING THROUGH
THIS STUFF FOR QUITE A WHILE,
EVEN WITH YOU.
AND MY QUESTION IS, YOU KNOW,
THERE ARE A LOT OF FOLKS OUT IN
THE COMMUNITY TRYING OR
ATTEMPTING TO DO SIMILAR THINGS
THAT YOU'RE TRYING TO WORK ON
HERE AT NICHD.
AND YOU KIND OF ANSWERED IT JUST
RIGHT THERE AT THE END, LIKE HOW
ARE WE WORKING WITH THOSE
INVESTIGATORS, A LOT OF THE
INSTITUTIONS THEMSELVES ARE
BEING FUNDED TO DO SOME OF THESE
TYPES OF THINGS, SO THERE'S A
LITTLE BIT OF A KIND OF PUSH TO
DO IT INTERNALLY AT NIH OR
EXTERNALLY, AND YOU KNOW, HOW
ARE WE INTERACTING AND MAKING
SURE THERE'S LIKE WHAT I CALL
KIND OF THE MAXIMAL FLEXIBILITY
FOR THE INVESTIGATOR, YOU KNOW,
BECAUSE WE JUST DON'T KNOW HOW
PEOPLE WANT TO INTERACT WITH
THESE DATA HALF THE TIME.
YOU KNOW, THERE'S THE THINGS
THAT WE THINK THAT SHOULD BE THE
MOST OBVIOUS, AND THEN SOMEBODY
WILL COME UP WITH THIS CRAZY
IDEA OF HOW THEY WANT DO IT.
SO LIKE MAKING SURE THAT, YOU
KNOW, THAT WE'RE LEVERAGING
RESOURCES THAT EXIST AT THE
UNIVERSITIES, OTHER
INSTITUTIONS, WHILE AT THE SAME
TIME PROVIDING OPPORTUNITIES
INSIDE -- YOU KNOW, INSIDE THE
NIH FOR MAXIMAL DATA ACCESS.
I'M CURIOUS HOW YOU'RE BALANCING
ALL THAT.
BECAUSE GETTING PEOPLE TO BUY IN
USUALLY -- JUST LIKE DIANA WAS
SAYING, YOUNG INVESTIGATORS AND
PEOPLE THAT'S TRYING TO --
PEOPLE WILL TAKE THE THINGS
THAT'S EASIEST FOR THEM.
IF THEIR OWN PLACES ARE ALREADY
PROVIDING SOME RESOURCES LIKE
THIS, THEN IT'S HARDER TO GET
THEM TO SWITCH TO SOMETHING
ELSE.
YOU KNOW WHAT I MEAN?
>> RIGHT.
AND I HEAR THAT.
I THINK THE EMPHASIS HERE AS
STATED BY THE POLICY IS ON BROAD
DATA SHARING.
AND SO WHAT WE NEED TO BE DOING
IS USING THESE ESTABLISHED
REPOSITORIES BECAUSE WE'VE
INVESTED IN THE INFRASTRUCTURE,
AND THEY HAVE A BROAD PLATFORM
TO COMMUNICATION OUT TO MANY
DIFFERENT RESEARCHERS THAT THESE
DATA ARE AVAILABLE, AND THEY
SHARE INFORMATION ABOUT THE DATA
SO ALL CAN USE IT.
SO WE ARE NOT ENCOURAGING THE
POLICY DOES NOT ENCOURAGE USING
CONSORTIUM DATA SHARING WITHIN A
UNIVERSITY BECAUSE THAT'S NOT IN
THE SPIRIT OF BROAD DATA
SHARING.
SO -- BUT I DO RECOGNIZE THAT
THERE IS A NEED TO STANDARDIZE
THE INTERFACES BETWEEN ALL OF
THESE SYSTEMS SO THAT THEY CAN
ALL TALK TO ONE ANOTHER, SO
PEOPLE CAN -- AND THIS GETS TO
THE QUESTION, THIS IS LED BY THE
OFFICE OF DATA SCIENCE STRATEGY,
AND WE ARE ENGAGED -- THE
PLATFORMS FOR INTEROPERABILITY,
WHERE WE ARE IMPLEMENTING, FOR
EXAMPLE, STANDARDS FROM THE
GLOBAL ALLIANCE FOR GENOMICS AND
HEALTH FOR HOW THE SYSTEMS TALK
TO ONE ANOTHER, HOW THEY CONVEY
METADATA ABOUT DATASET IN THE
REPOSITORIES, SO THAT THESE
SYSTEMS CAN TALK CONSISTENTLY
AMONGST THEMSELVES AND NEW
SYSTEMS WHEN THEY COME UP CAN
INTEGRATE INTO THE SYSTEM.
BUT GENERALLY, I STILL THINK IF
WE'RE TALKING ABOUT HUMAN DATA,
WHICH I THINK YOU ARE, WE DO
NEED TO BE TAKING INTO ACCOUNT
THAT CONTROL DATA ACCESS IS
IMPORTANT AROUND WE WANT TO BE
USING THESE ESTABLISHED DATA
REPOSITORIES THAT NIH IS
INVESTING IN TO MAKE SURE THAT
WE ARE APPROPRIATELY PROTECTING
THE DATASETS FOR PROVISIONING
ACCESS TO AUTHORIZED
RESEARCHERS.
>> THAT'S WHAT I'M SAYING, YOU
KNOW, THERE ARE A LOT OF PLACES,
A LOT OF -- SEVERAL INSTITUTIONS
AND MANY OF THEM THAT YOU KNOW
THAT HAVE BEEN VERY SUCCESSFUL
AT DISTRIBUTING HUMAN DATA IN A
CONTROLLED WAY.
YOU KNOW, AND PEOPLE USE ALL THE
TIME.
SO THAT'S WHY I THINK IT'S
REALLY IMPORTANT AS YOU'RE
WORKING THROUGH THIS TO THINK
THROUGH HOW YOU -- HOW DO YOU
WORK WITH THOSE REPOSITORIES TO
MAKE SURE THAT YOU'RE NOT
ALWAYS -- YOU'RE NOT FIGHTING
THE COMMUNITY, YOU KNOW, WITH
WHAT TO USE AND WHAT NOT TO USE
BECAUSE THOSE THINGS ARE FUNDED
EITHER BY NSF OR NIH MANY TIMES,
AND THE UNIVERSITY RESOURCES, SO
IT'S HARD BECAUSE THE SPACE IS
BROAD AND THERE'S LOTS OF FOLKS
WHO THINK THEY'RE THE BEST, YOU
KNOW?
SO THINK THROUGH HOW DO YOU WORK
WITH EVERYBODY TO MAKE A NATURAL
SYSTEM THAT FOLKS WILL GRAVITATE
TO.
>> RIGHT.
SHOULD WE GO TO ANOTHER
QUESTION?
>> I WAS GOING TO GO TO DR. EGAN
AS OUR LAST QUESTION.
>> I WILL BE BRIEF.
I WAS WONDERING, YOU KNOW, I CAN
SEE YOUNG INVESTIGATORS BEING
VERY INCENTIVIZED TO ACCESS THE
DATABASE, BUT I'M WONDERING
ABOUT PEOPLE WHO HAVE OLD DATA,
DO THEY FEEL LIKE WHO OWNS THE
DATA, WHEN ACTUALLY IT IS
SHARED, DO THE OWNERS OF THE
DATA FEEL LIKE THEY ARE
PROTECTED, OR I ALSO UNDERSTAND
FROM SOME RESEARCHERS THAT I'VE
COMMUNICATED WITH THAT THE DATA
CAN'T LEAVE THEIR STATE, YOU
KNOW, LIKE ALZHEIMER'S RESEARCH
ON SCANNING, BRAIN SCANS.
THEY CAN'T SHARE THEM WITH
ANYBODY.
THE STATES LIMIT THEM IN
SHARING.
HAVE YOU ADDRESSED SOME OF THAT?
AND THEN THE OTHER ONE QUICKLY
IS, ARE YOU THINKING ALSO OF THE
DATA HAVING PSYCHOMETRIC TOOLS?
IT'S A BIG GAP IN THE FIELD.
THERE IS VERY GOOD -- THERE'S A
LACK OF MEASUREMENTS THAT ARE
VALID MEASUREMENTS THAT WOULD BE
IN A DATABASE AND HAVE
REFERENCES.
I MEAN, I THINK DATABASES ARE
EXTREMELY IMPORTANT AND
CONGRATULATIONS.
>> THANK YOU, DR. EGAN.
THE QUESTION ON LIMITATIONS ON
SHARING, THE WAY THAT THE POLICY
IS WRITTEN, IT'S VERY CLEAR THAT
WHILE RESEARCHERS ARE EXPECTED
TO MAXIMIZE DATA SHARING, IT IS
ACKNOWLEDGED THAT THERE ARE
OFTEN LIMITATIONS ON DATA
SHARING.
SO IN THE PLAN, RESEARCHERS
EXPECT TO DESCRIBE AS CLEARLY AS
POSSIBLE WHAT THOSE LIMITATIONS
ARE WITH THE SOURCE OF THOSE
LIMITATIONS ARE, AND JUSTIFY
THAT TO THE PROGRAM OFFICERS FOR
REVIEW.
SO IF THERE IS, FOR EXAMPLE,
DATA COMING FROM A STATE HEALTH
FACILITY, THOSE DATA CANNOT
LEAVE A GIVEN SYSTEM, THAT COULD
BE DESCRIBED IN THE DATA
MANAGEMENT AND SHARING PLAN FOR
REVIEW BY NIH.
SO THERE IS FLEXIBILITY IN THAT.
WE DO ENCOURAGE THAT RESEARCHERS
CONSIDER DATA SHARING AT THE
OUTSET WHEN ACQUIRING DATASET
AND SUBMITTING AN APPLICATION
AND TRY TO WORK WITH DATA THAT
CAN BE SHARED IN SOME CAPACITY.
AND YOUR QUESTION ABOUT
PSYCHOMETRIC TOOLS AND
MEASUREMENT VALIDATION,
CURRENTLY THAT'S MORE OF A
PROGRAM PRIORITY AND OUT OF
SCOPE FOR OUR OFFICE.
BUT I DO RECOGNIZE THE
IMPORTANCE OF IT, AND I CAN SEE
A SPACE IN WHICH THIS GETS BACK
TO THE QUESTION FROM DR. ROWITCH
ABOUT STANDARDS.
THIS IS A SPACE WHERE WE ARE
WATCHING, WE ARE ENGAGING AT THE
WORKSHOP LEVEL, AND LEARNING
FROM WHAT THE COMMUNITY IS DOING
SO WE CAN START TO POINT TO
THESE STANDARDS AND MEASUREMENT
TOOLS AS RECOMMENDATIONS BUT OF
COURSE WE CAN'T ENDORSE
ANYTHING.
SO IT'S REALLY ABOUT JUST
KEEPING TRACK OF WHAT'S
HAPPENING IN THE COMMUNITY, AND
THAT IS WITHIN THE SCOPE OF OUR
OFFICE.
>> THANK YOU.
>> GREAT.
I WANT TO THANK EVERYONE FOR AN
INCREDIBLY RICH DISCUSSION.
REBECCA, THERE ARE A COUPLE OF
QUESTIONS AND COMMENTS IN THE
CHAT BOX.
WE DON'T HAVE TIME TO ANSWER
THEM NOW BECAUSE WE NEED TO
TECHNOLOGICALLY PIVOT TO THE
CLOSED SESSION.
BUT IF YOU COULD COPY THOSE
QUESTIONS AND THEN WE CAN GET
YOU THE EMAIL ADDRESSES OF THE
COUNCILMEMBERS SO THAT YOU COULD
ANSWER THEM INDIVIDUALLY, WOULD
THAT WORK FOR YOU?
THIS IS A TOPIC OF GREAT
INTEREST TO EVERYONE, AND WE
REALLY THANK YOU FOR COMING
TODAY.
WE'RE GOING TO INVITE YOU BACK
TO GIVE AN UPDATE.
MAYBE A YEAR FROM NOW, TO SEE
HOW THINGS ARE GOING.
ALL RIGHT.
WITH THAT, WE ARE GOING TO
CLOSE THE OPEN SESSION.