>> Joshua Gordon: WELCOME TO
THE 270th MEETING OF THE
NATIONAL ADVISORY MENTAL HEALTH
COUNCIL.
I'M JOSHUA GORD AN AND I'D LIKE
TO THANK YOU FOR JOINING OUR
MEETING TODAY.
EMBRACING OUR HYBRID FORMAT.
I'M JOINING YOU VIRTUALLY TODAY
FOR THE FIRST PART OF OUR
MEETING BUT WILL COME IN-PERSON
AFTER THE BREAK LATER THIS
AFTERNOON DUE TO AN EVENT HERE
ON CAMPUS THAT I NEED TO ATTEND.
OUR COUNCIL MEETING IS A TIME
FOR INFORMATION EXCHANGE BETWEEN
INSTITUTE STAFF AND COUNCIL
MEMBERS.
AS WELL AS AN OPPORTUNITY FOR
THE COUNCIL PROVIDE FEEDBACK TO
THE NATIONAL INSTITUTE OF MENTAL
HEALTH.
IT'S ALSO AN OPPORTUNITY FOR US
TO DISCUSS IN FRONT OF THE
PUBLIC THE MATTERS REGARDING
PRIORITIES AND POLICIES AT NIMH
THAT ARE IMPORTANT TO TALK
ABOUT.
WE HAVE A FULL SCHEDULE.
THANK YOU FOR PARTICIPATING IN
THIS MEETING.
BEFORE WE MOVE ON IT THE
BUSINESS OF THE MEETING, I'LL
TAKE A MOMENT TO REMIND YOU OF A
FEW LOGISTICAL ITEMS.
AS ALWAYS, NOT THIS OPEN SESSION
IS BEING VIDEO CAST BROADLY TO
THE NIH COMMUNITY AND TO THE
VIEWING PUBLIC.
ALLOWING PEOPLE TO WATCH AND
LISTEN REMOTELY.
THE MEETING IS ALSO BEING
RECORDED TO ALLOW VIEWING ON
DEMAND AT A LATER DATE.
WE ENCOURAGE COUNCIL MEMBERS
BOTH IN THE ROOM AND REMOTE TO
KEEP YOUR VIDEO ON THROUGHOUT
THE MEETING, SO THAT YOU CAN BE
SEEN BY THOSE OUTSIDE OF THE
ROOM.
HOWEVER, WE ASK THAT NIMH STAFF
INCLUDING DIVISION DIRECTORS USE
VIDEO ONLY WHEN PRESENTING.
FOR COUNCIL MEMBERS IN THE ROOM,
PLEASE USE THE MICS ON THE
TABLE.
ALWAYS PUSH THE ON BUTTON WHEN
YOU SPEAK AND OFF WHEN YOU ARE
DONE.
DO NOT TURN ON THE AUDIO FOR
YOUR COMPUTER, THE MICROPHONE IS
ON THE TABLE WILL PROVIDE THE
AUDIO FOR YOU.
FOR REMOTE COUNCIL MEMBERS,
UNMUTE YOUR MICROPHONE WHEN
SPEAKING AND PLEASE MUTE YOUR
MICROPHONE WHEN YOU ARE NOT.
FOR THOSE REMOTE MEMBERS WHO
MIGHT BE USING PHONE AUDIO, YOU
CAN PRESS STAR 6 TO MUTE AND
UNMUTE.
WE ASK COUNCIL MEMBERS TO UNMUTE
TO MAKE A COMMENT OR ASK A
QUESTION RATHER THAN USING THE
ZOOM AND CHAT FUNCTION.
PLEASE RESERVE CHAT USE FOR
CONTACTING NIMH ZOOM HOSTS WITH
ANY TECHNICAL ISSUES.
I WANT TO REMIND YOU THAT
EVERYTHING ENTERED INTO THE
CHATBOX, WILL BE INCLUDED IN THE
PERMANENT RECORD OF THE SESSION,
EVEN SIDE BAR CHATS TO OTHER
MEMBERS OF THE COUNCIL OR TO
STAFF WILL BE PART OF THIS
RECORD AND WILL BE PUBLICLY
AVAILABLE.
WHEN WE CALL FOR A VOTE, WE WILL
ASK ALL COUNCIL MEMBERS TO USE
THE RAISE-HAND FUNCTION IN ZOOM.
IT MIGHT BE LOCATED IN THE ZOOM
PARTICIPANT MENU OR THE BOTTOM
UNDER THE REACTIONS MENU
DEPENDING ON YOUR PARTICULAR
VERSION.
VOTING COUNCIL MEMBERS ON THE
PHONE SHOULD UNMUTE BY PRESSING
STAR 6 AND VOTE BY VOICE.
IF YOU EXPERIENCE CONDUCTIVITY
ISSUES AND YOU NEED TO CALL IN,
PLEASE REFER TO YOUR PERSONAL
ZOOM ITINERARY FOR THE OPEN
SESSION DETAILS.
WITH THAT, I'M GOING TO TURN IT
OVER TO TRACY WHO WILL SEE
COMMENTS AND CORRECTIONS TO THE
MINUTES AND CONDUCT A VOTE AND
THEN MOVE ONTO THE NEXT ITEM ON
OUR AGENDA.
THOSE OF YOU WHO ARE HOPING FOR
IT, I WILL BE GIVING THE FULL
REGULAR DIRECTORS REPORT
IMMEDIATELY AFTER THE BREAK AT
AROUND 2:30.
TRACY --
>>THANK YOU.
I'M SEEKING A MOTION FOR
APPROVAL OF OUR 2023 MINUTES
THAT THE COUNCIL MEMBERS HAD
ACCESS TO IN THE ASR IN ADVANCE
OF TODAY'S MEETING.
DO I HAVE A MOTION OF APPROVAL?
THANK YOU.
AND A SECOND.
OKAY.
GREAT.
ALL THOSE IN FAVOR OF APPROVING
THE MINUTES, PLEASE USE YOUR
RAISE-HAND FEATURE ON THE ZOOM.
PERFECT.
ALL RIGHT.
ALL THOSE OPPOSED.
ANY OPPOSED?
ALL RIGHT.
AND ANY ABSTENTIONS?
OUR MINUTES ARE ALL SET.
THANK YOU.
AND WE'LL TURN IT OVER TO SHELLY
TO GET US STARTED WITH CONCEPTS.
>>Shelly: GOOD MORNING, THANK
YOU FOR BEING ON THE ZOOM.
SO, AS JOSH ALLUDED TO WE'RE
GOING TO BE FLIPPING THE ORDER
AND WE'RE GOING TO START WITH
CONCEPT CLEARANCES.
TODAY YOU WILL HEAR ABOUT FUTURE
INITIATIVES BEFORE JOSH'S
DIRECTORS REPORT AND KEEP IN
MIND OUR CONCEPT CLEARANCES ARE
PRESENTED FOR EARLY FEEDBACK ON
THESE FUTURE RESEARCH DIRECTIONS
AND INCLUDING SUGGESTIONS TO
HELP SHAPE THESE POTENTIAL
INITIATIVES AS WE DEVELOP THEM.
OUR CONCEPT PRESENTATIONS ARE
INTENTIONALLY GENERAL AS WE ARE
IN THE VERY EARLY SEASONS OF
FORMULATING THESE SCIENTIFIC
CONCEPTS INTO POTENTIAL FUND
INITIATIVES.
OUR DESCRIPTIONS OF EACH
CONCEPTS WERE MADE AVAILABLE TO
YOU VIA THE ASR WITH YOUR
FEEDBACK AND NIH AIMS TO PROCEED
WITH THE RESEARCH ACTIVITY,
HOWEVER, THE PUB WILL INDICATION
AND TIMING URN CERTAIN AND
DEPENDING ON FUNDS BEING
AVAILABLE.
ONCE PRESENTED AT COUNCIL,
CONCEPTS ARE POSTED ON THE NIMH
WEBSITE AND AVAILABLE FOR
FURTHER COMMENT.
FOR THE PURPOSE OF TODAY'S
DISCUSSION, WE HAVE ASSIGNED TWO
COUNCIL MEMBERS FOR EACH CONCEPT
THOUGH WE WELCOME FEEDBACK FROM
ALL OF YOU.
SO, WE'RE GOING TO GET STARTED
WITH Dr. BOB HEINSEEN.
>>Robert Heinssen: THANK YOU
VERY MUCH 12 THANK YOU FOR THE
PENT TO RESERVE LEARNING IMPROVE
MENTAL HEALTH SERVICES AND
TREATMENT.
IMPLEMENTATION RESEARCH IS
DOCUMENTED BETWEEN SCIENTIFIC
DISCOVERY AND TRANSLATION
FINDINGS INTO RETAIN CLINICAL
PRACTICE.
MORE OVER, THE EFFECTIVENESS OF
RESEARCH-BASED TREATMENT OFTEN
DECLINES IN REAL WORLD CLINICAL
SETTINGS IMPLEMENTATION
SCIENTISTS WITH THIS PHENOMENON
VOLTAGE DROP.
HEALTHCARE WAS FIRST DESCRIBED
BY THE INSTITUTE OF MEDICINE IN
2007 AND AS A DATA DRIVEN
FRAMEWORK FOR MITIGATING THIS
DIMINISHMENT AND IMPROVING THE
QUALITY AND EFFECTIVENESS OF
EVIDENCE BASED SERVICES.
TO DO SO, LEARNING HEALTH
SYSTEMS INTEGRATE DATA
COLLECTION AND ANALYSIS INTO
CARE AND EMPLOY QUALITY
MANAGEMENT STRATEGIES TO
OPTIMIZE SERVICES AND PROVIDE
REAL-TIME FEEDBACK TO CLINICIANS
TO DRIVE IN PATIENT OUTCOMES AND
HEALTHCARE DELIVERY.
THESE CHARTS ILLUSTRATE RECENT
PROGRESS IN TWO FEDERALLY FUNDED
PROGRAMS THAT EMPHASIZE
EVIDENCE-BASED PRACTICES FOR
MENTAL DISORDERS.
ON THE LEFT IT ILLUSTRATES RAPID
GROWTH AND SUPPORTS PROGRAMS
THAT PROVIDE COORDINATED
SPECIALTY CARE.
A RESEARCH-BASED INTERVENTION
FOR FIRST EPISODES LIKE NOT
HOSES.
CHAT ON THE RIGHT REVEALS
SIMILAR GROWTH IN THE NUMBER OF
CERTIFIED COMMUNITY BEHAVIORAL
HEALTH CLINICS.
THESE CLINICS ARE EXPECTED TO
PROVIDE EVIDENCE-BASED PRACTICES
THAT MEET THE NEEDS OF CHILDREN,
YOUTH AND ADULTS WITH COMPLEX
MENTAL HEALTH AND SUBSTANCE USE
DISORDERS.
LEARNING HEALTHCARE METHODS CAN
BE TEST TESTED, REFINED AND EXD
IN OUT PATIENT CLINICS SUCH AS
THESE.
EITHER IN SINGLE SITE OR
RESEARCH NETWORK PROJECTS.
FUTURE RESEARCH CAN BUILD UPON
LESSONS LEARNED FROM EXISTING
INITIATIVES.
SUCH AS THE NIMH EARLY PSYCHOSIS
2 WILL PROMOTE RESEARCH DATA
SCIENCE AND EFFECTIVENESS AND
SERVICES RESEARCH TO CREATE
BETTER KNOWLEDGE AND TOOLS FOR
DELIVERING AND ON TA MISSING
EVIDENCE-BASED MENTAL HEALTH
SERVICES.
THE CONCEPT ALIGNS WITH
EFFECTIVENESS RESEARCH,
IMPLEMENTATION SCIENCE, AND
HEATH EQUITY GOALS OUTLINED IN
THE PLAN FOR RESEARCH AND ARE
RECENT WHITE HOUSE REPORT ON
MENTAL HEALTH RESEARCH
PRIORITIES.
THIS SLIDE HAVE AREAS CONSIDERED
UNDER THIS CONCEPT AND WE
ENVISION STAKEHOLDER ENGAGE
RESEARCH THAT WILL LEVERAGE
CLINICAL PRACTICE DATA INTO
ACTION AND IMPLEMENT LEARNING
HEALTHCARE METHODOLOGY TO
IMPROVE PREVENTATIVE AND
TREATMENT INTERVENTIONS FOR
PERSONS WITH MENTAL HEALTH.
THANK YOU ALL FOR YOUR ATTENTION
AND I LOOK FORWARD TO THE
DISCUSSION AND QUESTIONS FROM
COUNCIL.
I BELIEVE WE HAVE Dr. KILBORN
AND TELLFAIR HAVE AGREED TO
DISCUSS AND Dr. TELLFAIR, YOU
ARE IN THE ROOM.
>>IT CAUGHT ME OFF GUARD WITH
THE OUT OF ORDER.
SO, NO, IN REVIEWING THIS, I WAS
APPRECIATIVE OF THE IDEA AND THE
CONCEPT.
IT WAS WRITTEN BROADLY BUT IT'S
STILL VERY BROAD TO ME.
IN TERMS OF FESS PHYSICAL TEE SO
MY COMMENTS, WHILE I AGREE THAT
WE SHOULD MOVE FORWARD WITH THIS
HAVE TO DO WITH SPECIFICITY SO I
WILL LEAVE IT AT THAT. THE FIRST
PART OF THE QUESTION IS THAT I
WOULD BE REALLY HELPFUL IN THIS
SCOPE THAT YOU IDENTIFY WHO THE
RESEARCHERS MIGHT BE WHO WOULD
BEST BENEFIT FROM THIS WORK.
AND AT WHAT LEVEL THEY MIGHT BE
IN TERMS OF THE BENEFIT OF THE
WORK BECAUSE I CAN SEE PERSONS
BEING VERY ADVANCED AND I CAN
SEE PEOPLE BEING VERY JUNE
TAKING ADVANTAGE OF SUCH AN
OPPORTUNITY SO WHO THE RESEARCH
AND WHAT LEVEL IS USEFUL.
THERE ARE PRACTICAL STEPS I NEED
TO TAKE INTO ACCOUNT.
BECAUSE OF YOUR FOCUS ON AND HAS
AN EQUITY FOCUS NA MEANS YOU
HAVE TO JUST ACCORDINGLY.
THERE'S A COUPLE THINGS, FIRST
ACCESS IS GOING TO BE A BIT OF A
CHALLENGE PARTICULARLY RELATIVE
TECHNOLOGICAL ELEMENTS OF THIS
AND NOT EVERYONE HAS A COMPUTER
BUT EVERYONE HAS A SOPHISTICATED
SOFTWARE AS WELL AS THE POWER TO
USE SOME OF THIS RESEARCH AND
PARTICULARLY IF THE WORK ITSELF
WILL BE IMPLIED IN COMMUNITY
SETTINGS AND THAT SORT OF THICK.
THE SECOND PART, THERE'S THAT
THE IN THE STRATEGIC PLAN REALLY
DOES NEED TO JUST BE HIGHLIGHTED
IN TERMS OF HOW YOU SEE IT BEING
APPLIED.
WHEN YOU THINK ABOUT THE
POPULATION MIGHT BE SO THOSE ARE
MY COMMENTS ON THAT AND I'LL
KEEP THEM BRIEF.
I THOUGHT IT WAS A GOOD IDEA, MY
BIGGEST CHALLENGE WAS JUST
WRAPPED AROUND IN NOT HOW IT
MIGHT BE USED AND THAT SORT OF
THING SO I'LL LEAVE IT THAT THE
AND LEAVE IT TO MY COLLEAGUES.
>>THANK YOU, VERY MUCH.
>>THANK YOU FOR THE OPPORTUNITY
TO COMMENT ON THIS.
THIS IS A GREAT PROPOSAL.
I THINK VERY IMPORTANT DIRECTION
AND PROBABLY NO OTHER GROUP
OTHER THAN NIMH WOULD BE IN A
GREAT POSITION TO PROMOTE THE
NEXT GENERATION OF SCIENCE AND
LEARNING HEALTH SYSTEMS GIVEN
THE COMPLEXITIES OF WHAT WE
FACE.
I AGREE WITH WHAT WAS SAID
EARLIER.
I THINK I WOULD ADD TOO SOME
ADDITIONAL ANGLES IN WHICH TO
CONSIDER EXPANDING AND PROVIDING
DETAIL.
THE FIRST IS PERHAPS, LOOKING AT
THE QUESTION AROUND
INFRASTRUCTURE BECAUSE I THINK
FOR ANY -- AND I'M GLAD YOU
CALLED OUT IMPLEMENTATION
SCIENCE AND THE USE OF
IMPLEMENTATION STRATEGIES IN
GENERAL TO MAKE THOSE SUCCESSFUL
AND SUSTAINABLE, THERE NEEDS TO
BE SOME REALLY GOOD FOUNDATIONAL
RESEARCH OBJECT THE SCIO
TECHNICAL INFRASTRUCTURE OF WHAT
A LEARNING HEALTH SYSTEM DOES,
PARTICULARLY ALSO WITH THE
REALLY THE DIGITAL DIVIDE AND
THE ISSUES AND EQUITY AROUND
ACCESS TO ELECTRONIC HEALTHCARE
DATA OR JUST BASICALLY EVEN JUST
BASIC SERVICES AROUND COLLECTING
INFORMATION IN AN AUTOMATED WAY
ABOUT HEALTHCARE OUTCOMES TO
MAKE THE LEARNING HEALTH SYSTEM
FUNCTION IN GENERAL.
THE SECOND AREA TO CONSIDER 1
WORKFORCE.
YOU NEED TO HAVE PROVIDERS THAT
ARE WILLING TO IMPLEMENT THESE
AND NOT BE BURNED OUT OR DEALING
WITH OTHER COMPETING DEMANDS SO
WE'RE ENHANCING THE WORK FOR,
MENTAL HEALTH THAT CAN ALSO HAVE
LONG-TERM OUTCOMES ON THE MENTAL
AND PHYSICAL HEALTH OF THE
PEOPLE THAT THEY SERVE.
SO THAT'S ANOTHER AREA TO
CONSIDER AND SOMETHING THAT'S
BEEN CALLED OUT I'VE SEEN IN
OTHER AREAS OF NIH'S WORKFORCE
AS WELL.
I WOULD SAY THAT I THINK THE
FUTURE DIRECTIONS ARE ON
IMPLEMENTATION SCIENCE IN THE
LEARNING HEALTH SYSTEM ARE
FORMING WHAT'S CALLED A LEARNING
COMMUNITY AND HAVING COMMUNITY
INPUT IN WHAT IS PRIORITIZED IN
WHAT WE'RE LEARNING AND HOW
WE'RE IMPLEMENTING THINGS SO
WAYS WE CAN INVOLVE COMMUNITIES
ACROSS THE TRANSLATE TIVE, NOT
JUST THE LEARNING HEALTH SYSTEM
CYCLE BUT WAYS IN WHICH THE
COMMUNITIES COULD BE INVOLVED
AND EMPOWERED TO SHAPE THE WAY
THE LEARNING HEALTH SYSTEM IS
FORMED.
TO ACCESS THE QUESTION AND HOW
DO WE ENGAGE WITH PEOPLE WHO MAY
NOT HAVE REGULAR ACCESS TO
MENTAL HEALTH HEALTH SERVICES
WHAT WOULD THEY LOOK LIKE IN THE
COMMUNITY.
I WOULD SAY FINALLY ANOTHER
ANGLE IS THINKING WITH GO AND
PARTICULARLY WHAT CAN WE LEARN
FROM MOW AND MIDDLE INCOMMUTE
COUNTRIES IN TERMS OF WHAT
THEY'VE DONE ON A SHOW STRING
BUDGET THAT IN LEARNING THE
HEALTH SYSTEM SO THOSE WERE
THOUGHTS TO ENHANCE AND
HOPEFULLY THEY CAN BE HELPFUL
AND PLUSH IT OUT AND ENHANCING
WHAT YOU'VE CREATED IN THIS
GREAT AREA.
THANK YOU.
>>THANK YOU, AMY.
OPEN IT UP FOR OTHERS.
>>I KNEW IT WAS SOMETHING I
LEFT OFF.
I HAVE TWO OTHER COMMENTS ON
THIS.
BECAUSE THE NATURE OF THE, WHAT
YOU -- THE CONCEPT ITSELF, THE
MECHANISM OF SUPPORT IS OPENED
UP SO YOU HAVE DIFFERENT LEVELS
OF THAT AND EVERYTHING FROM A
SMALL THREE TO A VERY LARGE ONE
AND SECOND OF ALL, THE SCOPE OF
SCHOLARSHIPS NEEDS TO BE OPEN
BECAUSE TO AS MANY OF THE DHS
AGENCIES THAT YOU COULD PARTNER
WITH REGARDING THIS BECAUSE YOU
ARE LOOKING AT IMPLEMENTATION
AND APPTATION IN DIVERSE SETS.
OTHER COMMENTS OR QUESTIONS?
>>RELATED ACTUALLY
INCORPORATING BOTH DISCUSSANTS
IS AROUND THE ALL OUTS FOR THE
EARLY PSYCHOSIS NETWORK AND
THROUGH SAMHSA HAS A DIFFERENT
KIND OF FUNDING INFRASTRUCTURE
FOR COMMUNITIES ORGANIZATIONS TO
PARTICIPATE WITH ACADEMIC
INSTITUTIONS, ET CETERA SO I
THINK THAT BECAUSE THIS IS GOING
TO BE A REALLY BIG LIST FOR THE
COMMUNITY ORGANIZATIONS WHO ARE
ALREADY DEALING WITH A
SIGNIFICANT WORKFORCE ISSUE.
THIS IS SUCH A NEED AROUND JUST
REFLECTIVE PRACTICE AND BECOMING
ORIENTED AROUND DATA AND
OUTCOMES SO IT'S WONDERFUL FROM
THAT REGARD BUT IT'S THE SAME
PEOPLE WHO WILL BE CALLED THEN
TO DO ALL THE OTHER THINGS.
SO LEVERAGING SOME OF THE WAYS
THAT THE SUPPORT IS FOR EARLY
PSYCHOSIS AS WELL AS WOULD BE
NICE.
>>GO AHEAD.
IT'S WHERE YOU COULD USE
TECHNOLOGY TO AUTOMATE A LOT OF
DATA COLLECTION THAT THEY HAVE
TO DO AND A LOT OF THE CHARTED
AND EVEN A LOT OF THE SCORING
AND SO ON AND SO, IDEALLY, THIS
WOULD FREE UP COMMISSIONS AND
MORE DEMANDS ON THEM AND MAYBE
MANY FOR SUCCESS.
>>
>>AS YOU THINK ABOUT IT AND IT
SEEMS LIKE A STRENGTH HERE BUT
MY UNDERSTANDING FROM THE
PSYCHOSIS WORK IS THE IMPORTANCE
OF CONNECTING TO INTERNISTS AND
OTHER MEDICAL INDIVIDUALS THAT
MIGHT FIRST SEE PATIENTS,
PARTICULARLY IN RURAL
COMMUNITIES AND HOW MUCH AS SOON
AS YOU FOCUS ON HEALTH CLINICS
AND I JUST WONDERED HOW MUCH THE
ROLE OF BEING ABLE TO CONNECT TO
OTHER MORE GENERAL CLINICS AND
IT MIGHT BE WHERE PEOPLE ARE
FIRST SEEING THAT SEEMS ONE OF
THE ACCESS CHALLENGES BECAUSE
THEY MAY NOT HAVE THE
CONNECTIONS TO THE MEDICAL
RECORDS BUT IT'S A CASE WHERE
YOU CAN HAVE THE BIGGEST IMPACT
JUST IN THE FIRST EPISODE OF
PSYCHOSIS AND THAT MIGHT BE NOT
JUST GENERAL PRACTITIONERS BUT
SCHOOL SYSTEMS AND BE THE HIGH
SCHOOL OR COLLEGE SYSTEMS SO I
JUST WONDER HOW MUCH IT'S
THOUGHT OF.
IT DIDN'T SEEM IN WHAT YOU
PRESENTED TO BE AS BROAD AS IT
MIGHT BE THINKING ABOUT GENERAL
PRACTITIONERS IN THE MENTAL
SENSE AND CLINICAL PSYCHOLOGISTS
IN THE HIGH SCHOOL.
>>THANK YOU FOR THAT QUESTION.
I THINK IN BOTH OF THE EXAMPLES
OF THE CLINICS FOR FIRST EPISODE
SIGH SEW SIS AND THE CERTIFIED
COMMUNITY BEHAVIORAL HEALTH
CLINICS THERE'S A GOAL THERE TO
SINK INTEGRATED CARE PHYSICAL
HEALTHCARE AS WELL AS CARE FOR
THEIR PSYCHIATRIC CONDITIONS
WITH PROVIDERS AND PRIMARY CARE
AND SO FOURTH AND IT'S BEEN SEEN
AS A ESTABLISHING THOSE
RELATIONSHIPS WOULD BE A WAY OF
BENEFITING GROUPS AND PEOPLE
COULD BE IDENTIFIED EARLIER IN
THEIR STAGE OF ILLNESS AND REFER
THEM TO APPROPRIATE CARE AND
THEN ALSO WHEN PEOPLE COMPLETE
THEIR ACUTE CARE THAT THERE'S
THAT CONNECTION AND WE'VE DONE
BETTER WITH THAT THEN WE HAVE IN
INTEGRATING MAKING THOSE SCHOOL
SYSTEMS AND SO THAT IS CERTAINLY
IN THE PRESIDENT'S REPORTS THAT
WAS IDENTIFIED AS AN AREA THAT
NEEDS GREET ERA TENSION AND THAT
WOULD BE SOMETHING THAT WOULD
DEFINITELY BE ENCOURAGED THROUGH
AN INITIATIVE LIKE THIS.
THANK YOU VERY MUCH, BOB.
WE'LL MOVE ON.
WE'RE MOVING ON TO MICHAEL.
>>Michael: THANK YOU SO MUCH.
YES ON BEHALF OF THE DIVISION OF
AIDS RESEARCH IT'S MY PLEASURE
TO PRESENT OUR CONCEPT ON
ADVANCING HIV TESTING THROUGH
PHARMACY AND PHARMACISTS.
AND THE NEXT SLIDE, PLEASE.
SO OUR INTEREST IN PHARMACIES
HAS BEEN REINFORCED, THE
DRAMATIC IMPACT THAT PHARMACIES
HAVE HAD ON REACHING CONSUMERS
FOR COVID-19 VACCINES DELIVERY.
THEY HAVE DELIVERED MORE THAN
300 MILLION VACCINE DOSES
THROUGH 40,000 PHARMACY
LOCATIONS NATIONWIDE IN THIS
DEMONSTRATION SERVES AS A PROVE
OF CONCEPT OF THE INCREDIBLE
REACH AND IMPACT THAT PHARMACY
PROGRAMS CAN HAVE.
PHARMACIES CAN OFFER MANY
ADVANTAGES TO HIV SERVICE
DELIVERY AS WELL.
THIS INCLUDES CONVENIENT WEEKEND
AND EVENING HOURS AS WELL AS
NEIGHBORHOOD LOCATIONS.
FOR EXAMPLE, IT IS ESTIMATED
THAT AMERICANS LIVE WITHIN FIVE
MILES OF A PHARMACY AND
PHARMACISTS RESERVE HIGH RATINGS
IN CONSUMER TRUST AND THEY'RE AS
STIGMATIZING ENVIRONMENTS IN
WHICH TO ACCESS HEALTHCARE.
THE RETAIL PHARMACIES IN RECENT
YEARS HAVE EXPANDED THE DELIVERY
OF CLINICAL SERVICES WITHIN THE
LOCATIONS TO BASIC HEALTHCARE
NEEDS BEYOND THE RECEIPT OF
PRESCRIPTIONS.
FOR THOSE REASONS THE CURRENT
U.N. NATIONAL HIV/AIDS STRATEGY
HIGHLIGHTS THE KEY ROLE THAT
PHARMACIES AND PHARMACISTS CAN
PLAY IN A COMPREHENSIVE APPROACH
TO HIV PREVENTION AND CARE AS
STATED ON THIS SLIDE.
THE NEXT SLIDE, PLEASE.
SO THIS INITIATIVE WOULD HAVE
TWO PRIMARY GOALS MANY OF THE
FIRST TO SUPPORT RESEARCH TO
FURTHER KA PASS TATE AND STALE
TESTED AND PREVENTION AND CARE
THROUGH PHARMACISTS AND PHARMACY
SETTINGS.
AND THE SECOND IS TO ADVANCE
TRAINING AND PROGRAMS TO ENABLE
PHARMACY STUDENTS, PHARMACISTS
AND PHARMACIES THESE ARE TWIN
GOALS COMPLIMENTARY TO ONE
ANOTHER.
ZOO, SOME RESEARCH QUESTIONS TO
PURSUE ON THIS TOPIC WILL
INCLUDE THEY'RE NOT LIMITED TO,
IS PHARMACY BASED SCREENINGS FOR
MULTIPLE CHRONIC ILLNESSES
INCLUDING HIV INCREASE THE USE
OF HIV TESTING.
HOW CAN PHARMACY SUPPORT THE
TAKE AND DELIVERY OF HIV
PREVENTATIVE MEDICINE INCLUDING
NOVEL INJECTABLE PREP REGIMENTS.
CAN PHARMACY PRESCRIPTION
MONITORING IDENTIFY PEOPLE WITH
REFILLS WHO ARE AT RISK OF
DROPPING OUT OF HIV CARE AND
HELP WITH MAINTAINING CARE.
AND FINALLY, WHAT TRAINING
CURRICULUM CAN IMPROVE THE
CAPACITY FOR PHARMACIES AND
PHARMACY STUDENTS TO SUPPORT HIV
TESTING PREVENTION AND CARE?
OUR KA VISION WOULD BE EXCITE
TODAY PURSUE ANSWERS TO THESE
AND OTHER QUESTIONS THROUGH THIS
INITIATIVE AND WE PRESSURE
ATTENTION AND WE WELCOME YOUR
INPUT AND WE'RE GLAD TO ADDRESS
ANY QUESTIONS.
>>THANK YOU, MICHAEL.
SO WE HAVE DRUNK DRI DOCTOR TELD
MURRAY.
>>
>>THANK YOU, VERY MUCH.
SO THANK YOU AGAIN FOR THE
OPPORTUNITY TO REVIEW THIS.
APPROXIMATE I ENJOYED READING
IT.
SO I HAVE A LOT OF -- I WOULDN'T
SAY A LOT, RELATIVELY POINTED
QUESTIONS ON IT SO THE WHOLE
IDEA OF THE PHARMACISTS ON THE
INCREASING ROLE THE FIRST THING
THAT COMES UP IS THE WORKFORCE
QUESTION RELATED TO TRAINING AND
I KNOW THAT THIS MIGHT -- IF
IT'S OUTSIDE THE SCOPE OF THIS,
TRAINING TO ADVANCE THE SKILLS
OF KNOWLEDGE OF PHARMACISTS
MAINLY BECAUSE OF THE WAY
THEY'RE TRAINED AT DIFFERENT
LEVELS AND DIFFERENT TYPES SO SO
IT'S A VERY IMPORTANT PART.
THE OTHER PART IS THE FIT WHAT
IS IN PART WHAT WHERE IS THIS
ROLE AND THE FIT THERE IN TERMS
OF YEAR WORK AND IN YOUR AREA
AND I HOPE IT'S CLEAR.
WHAT I'M TRYING TO GET AT WHERE
WOULD THE FIT WE SO THAT WHEN IT
IS PRESENTED TO THE PHARMACISTS,
LIKE THE PHARMACIST ASSOCIATION
THAT THING THEY CAN SAY OKAY WE
HAVE A CLEAR IDEA OF HOW THIS IS
DONE AND HERE IS HOW WE CAN DO
THIS.
BECAUSE THE WAY I KNOW WOMEN IN
RURAL AREAS THERE'S A CRITICAL
ROLE THAT ASSOCIATIONS PLAY IN
BEING ABLE TO ROLLOUT THIS WORK
SO THAT'S CRITICALLY IMPORTANT
AND SO THE DESIGN IS GOING TO BE
CRITICAL HERE AND BECAUSE OF THE
TYPE OF WORK THAT'S BEING DONE
BECAUSE YOU ARE LOOKING AT BOTH
DOMESTIC AND GLOBAL AND PHARMACY
SERVICES IN GLOBAL SIGHTINGS
HAVE A RURAL CHALLENGE BECAUSE
THEY'RE DEALING WITH EVERYDAY
WITH THE FAKE INFORMATION
CHALLENGE THAT GOES OUT SO
DEPENDING ON WHERE IT IS THAT
THIS MIGHT BE BECAUSE QUALITY
SCROLL ASSURANCE IS GOING TO BE
YOUR BIGGEST THING AND WHEN IT'S
NOT DONE THIS ROLLOUT FAILS AND
FALLS FLAT AND IT'S HARD TO
RECOVER FROM THAT SO THAT WOULD
BE SOMETHING THAT IT WENT
THROUGH OFTEN IT'S VERY TRUE THE
MODELS ARE CRITICAL HOWEVER THE
BIG CHALLENGE THAT ARE ALSO
SEEING THAT I'M NOT SURE THIS IS
WHERE MAYBE ANOTHER CAN HELP YOU
WITH SAMHSA AND IT'S THE SOCIAL
POLITICAL AND CULTURAL TYPE OF
IS ELIGIBLE AND THE IF IT'S
DIRECTED TO THEM AND YOU ARE
FAMILIAR WITH THE CONCEPT OF THE
POLITICAL AND THAT PLAYS A BIG
ROLE HERE AND THAT BECAUSE OF
STIGMA AND OTHER THINGS SO IT
MAY BE IMPORTANT MANY OF I WOULD
ALSO LOOK AT THE REFERRAL
PROCESS BECAUSE ONE OF THE
THINGS THAT PHARMACISTS NOW ARE
DOING IN I'M SURE YOU KNOW THIS
IS THAT THEY'RE ALSO RECOGNIZING
THAT THERE ARE CO-MORBIDITY AND
MENTAL HEALTH AND A LOT OF
PERSONS HAVE AND SO A MECHANISM
THEY CAN INCREASE AND BE MORE
PRECISE WITH THE REFERRAL IN THE
OTHER MENTAL HEALTH HEALTH
PROFESSIONALS O OF ONE TIME OR
ANOTHER WILL BE VERY IMPORTANT
TO DO AND BECAUSE THIS IS A
INTERVENTION BASED TYPE OF
RESEARCH IT CAN BE REPLICATED
AND EXPANDED IN DIVERSE PHYSICAL
AND SOCIAL TYPE OF ENVIRONMENT
AND AGAIN, BECAUSE YOU ARE
RIGHTLY SO, TALKING ABOUT
SUCCESSFUL BOTTLES LIKE PREP AND
OTHER APPROACHES THE PHYSICAL
AND SOCIAL BEHAVIORAL ISSUES
THAT EXIST WITH THE EXPANSION
WILL BE VERY IMPORTANT.
FOR THE MOMENT THAT'S ALL I
HAVE.
>>THANK YOU.
>>GREAT SUMMARY FROM Dr.
TELFAIR AND I WAS EXCITED HAVING
THE OPPORTUNITY TO READ THIS
CONCEPT AND SO I REVIEW WITH
GREAT ENTHUSIASM WITH ALSO
CONCERNS ABOUT FACE PHARMACY
DESERTS IN RURAL COMMUNITIES AND
IN URBAN COMMUNITIES AND SO IT
WAS ABOUT THE RAISING IS TARGET
FORWARD THIS AND A REASON FOR
THIS AS AN OUTLET IS BECAUSE OF
THE NEEDING TO REACH PARTICULAR
POPULATIONS WHERE ACCESS IS AN
ISSUE AND SO IT'S ASKING
QUESTIONS ABOUT HOW DO WE
IDENTIFY WAYS TO OVERCOME THOSE
CHALLENGES THAT YOU MENTIONED IN
YOUR CONCEPT PAPER AS FOR THE
POPULATIONS THAT AGAIN ARE IS
HOW WOULD YOU UTILIZE AND LIKE
THE IDEA OF THE LEARNING
COMMUNITIES MENTIONED EARLIER IS
IN THE PROCESS OF THINKING ABOUT
THIS PLATFORM AND THE OTHER
SEARCH IS BEING ABLE TO LOOK
MORE AT THE SOCIAL POLITICAL
STRUCTURE AND REALLY AS A
POTENTIAL TESTING SITE FOR PREP
AND THE OTHER IDEA I THOUGHT
ABOUT WAS BEING ABLE TO
PHARMACIES IN STATES WHERE
FUNDING FOR HIV WAS NOT BEING
RECEIVED WELL AND IN FACT I'M IN
A STATE WHERE CDC FUNDING FOR
HIV HAS BEEN DENIED AND THEY'RE
NOT ACCEPTING THE FUNDING.
HOW MUCH THAT EVEN IF ENOUGH
THOSE PHARMACIST AND THEY WILL
HAVE TO DEAL WITH THIS POLL ITS
FALLOUT AS THEY UPTAKE THIS AS A
MODEL FOR DISTRIBUTING PREP AND
HOW MIGHT THERE BE WAYS TO
LEVERAGE THE PIONEERING EFFORTS
UNDERTAKEN AS A WAY OF LEARNING
HOW TO DO THIS AND THEN FINALLY,
IT'S TO THINK ABOUT WAYS IN
WHICH THE SERVICES THAT MAY BE
IMPLEMENTED IN PHARMACIES FOR
PREP THEY ARE DOING THIS WORK
TRYING TO IDENTIFY WAYS TO
INCREASE PREP UPTAKE TARGETING
THE POPULATIONS AND HOW MIGHT
RESEARCH TO BE DESIGNED WHERE
THERE'S CO OF THE CHALLENGES
THAT IS GOING TO OCCUR AND WE
HAVE TO ADMIT THAT ACCESS IS
GOING TO BE A CRITICAL ISSUE AND
SO SIMILAR TO WHAT WE SAW WITH
COVID-19 IN TERMS OF WHO GREATER
ACCESS TO THE SERVICES NEED AND
WILL WE FIND A REP LATATION WITH
THE CONCEPT YOU ARE PROMOTING
WITH THIS APPROACH TO REACH
LARGER POPULATIONS THAT DON'T
HAVE ACCESS TO AND READILY
UPTAKE PREP AS A CONFERENCE OF
LOTS OF BARRIERS INCLUDING
SOCIAL STIGMA BUT A GREAT IDEA
AND LOOKING FORWARD TO ABOUT
WHAT MIGHT COME NEXT.
>>OPENING UP IT FOR COMMENTS OR
QUESTIONS.
>>
>>THIS IS A CON SPENT IT HAD TO
DO WITH CO-MORBIDITIES AND YOU
MIGHT INCLUDE AMONGST THE TOPICS
HOW CAN YOU EQUIP THESE
PHARMACISTS TO BE RESOURCES SO
MIGHT YOU INCLUDE HOW COULD
KNOWLEDGE AROUND OST AS WELL AS
PREP BE OF VALUE TO PHARMACISTS
AND HOW COULD PHARMACISTS
RESOURCES FOR PEOPLE SEEKING
HARM REDUCTION ALONG WITH HIV
AND OTHER HIV SERVICES.
>>THANK YOU.
I WAS INTERESTED IN HEARING HOW
THE HIV COMMUNITY IS GOING TO BE
INVOLVED IN IS STRUCTUREING AND
DEVISING SERVICES THAT MIGHT BE
HELPFUL.
>>THERE ARE WAYS WE HAVE INPUT
AND HOLD A MEETING LATER THIS
YEAR AND AT WHICH WE GET
ADVISEMENT FROM MANY SECTORS NOT
JUST PHARMACY AND PHARMACY
ASSOCIATIONS AND THEY ALSO FROM
THE COMMUNITY FROM COMMUNITY
MEMBERS IS THEMSELVES AND I
APPRECIATE THE RESEARCH TEAMS
AND HOW WE APPROXIMATE ENSURE
EVERYONE IS AT THE TABLE TO HELP
DRIVE THE RESEARCH AND THEN TO
INVOLVE COMMUNITY INPUT AS WE
TRIED TO BUILD THE PROGRAMS THAT
WILL DELIVER THESE SERVICES
WHETHER IT'S TESTING AND WE HAVE
PROGRAM AND SO WE WANTED MAKE
SURE AS WE PIONEER THIS PROGRAM
AND WE SCALE BACK, THE IT'S IN A
WAY THAT IS ACCEPTABLE AND
DESIRABLE FOR THE COMMUNITIES
AND FOR THOSE WHO CAN MOST
BENEFIT.
IT'S A VALUE WE SHARE AND
SOMETHING THAT WE WILL
PRIORITIZE.
>>WE'LL GO AHEAD AND MOVE ALONG
TO OUR LAST CONCEPT CLEARANCE
FOR I DAY.
PRESENTED BY Dr. THERESA SENN
FOCUSED ON STREAMLINING MENTAL
HEALTH INTERVENTIONS FOR YOUTH
LIVING WITH HIV.
>>THANK YOU FOR THE OPPORTUNITY
TO PRESENT THIS INITIATIVE ON
STREAMLINING MENTAL HEALTH
INTERVENTIONS FOR YOUTH LIVING
WITH LIVE AND LOW AND MIDDLE
INCOME COUNTRIES.
I WANT TO ACKNOWLEDGE MY
COLLEAGUE EQUAL CONTRIBUTIONS TO
THE INITIATIVE.
AT LESS ENTERS AND YOUNG PEOPLE
REPRESENT A GROWING SHARE OF
PEOPLE LIVING WITH HIV WITH 1.75
MID YUN LIVING WITH HIV
GLOBALLY.
YOUTH LIVING WITH HIV HAVE POOR
OUTCOMES ALONG THE HIV CARE
CONTINUUM.
THIS IS LOW RATES OF VIRAL
SUPPRESSION EVEN WHEN THERE'S
ACCESS TO RETRO FIE RAL THERAPY
IN ADDITION, THERE'S MENTAL
HEALTH ORDERS OF YOUTH LIVING
WITH HIV AND THEY ARE ASSOCIATED
WITH POOR HIV CARE CONTINUUM
OUTCOMES.
NEXT SLIDE.
THEY ARE UNIQUE PERIODS OF
DEVELOPMENT THERE'S INCREASED
ONSET OF COMMON MENTAL DISORDERS
AND RAPID BRAIN DEVELOPMENT,
SHIFTING SOCIAL AND HEIGHTENED
CONCERNS AROUND STIGMA.
THREE FACE CHALLENGE AS THEY
TRANSITION TO SERVICES AND
NAVIGATE NEW ROMANTIC
RELATIONSHIPS AND MOVE OUT OF
THE FAMILY HOME AND BECOME
PARENTS THEMSELVES.
THEY MAY NEED TO BE ADAPTED TO
THESE UNIQUE CONTEMPTS
ADDITIONALLY IN MANY LOW AND
MIDDLE INCOME COUNTRIES THERE
ARE NOT ENOUGH MENTAL HEALTH
PROVIDERS FOR THE POPULATION IN
NEED OF SERVICES AND THIS MENTAL
HEALTH GAP IS PARTICULARLY ACUTE
FOR YOUTH MENTAL HEALTH WORKERS
AND WITH AN ESTIMATED .01 YOUTH
NEXT SLIDE.
THEREFORE, THE GOAL FOR THIS
INITIATIVE, IS TO ADAPT FOR
YOUTH LIVING WITH HIV IN LOW AND
MIDDLE INCOME COUNTRIES TO
IMPROVE PROVIDERS AND
IMPLEMENTERS TO THEY WANT TO
EVIDENCE MENTAL HEALTH IN A
EVIDENCE BASED WAY BUT DON'T
HAVE THE RESOURCES TO DELIVER
COMPLEX SESSIONS.
THE FIRST IS TAILORING
INTERVENTIONS AND SO THESE
INTERVENTIONS WOULD NEED TO BE
TAILORED TO THE FACTORS UNIQUE
TO ADOLESCENTS LIVING WITH HIV
AND AS DISCUSSED ON THE PREVIOUS
SLIDE.
AND THE SECOND COMPONENT IS SLAM
TRAINING FOR INTERVENTIONS BY
THIS WE BROADLY HAVE BEEN USING
FEWER RESOURCES LIKE TIME OR
MONEY OR NUMBER OF PROVIDERS.
SO SOME ARE THINGS LIKE WHAT
ADAPTATIONS NOR THE UNIQUE
CONTEMPT OF ADOLESCENTS LIVING
WITH HIV.
WHAT ARE THE CRITICAL COMPONENTS
OR THE MINIMAL DOSE OF AN
INTERVENTION THAT MUST BE
DELIVERED TO ACHIEVE MEANINGFUL
IMPROVEMENTS AND AT WHAT POINT
SHOULD WE INTENSIFY SORRY LISTEN
WHAT STRATEGIES IS COULD BE USED
WHILE MAINTAINING AND HOW CAN WE
MATCH THE APPROPRIATE
INTERVENTION ARE THE APPROPRIATE
INTENSITY INTER CONVENIENCE.
THANK YOU AND I LOOK FORWARD TO
THE COUNCIL DISCUSSION.
>>THANK YOU VERY MUCH.
IT'S Dr. COLLINS AND Dr.
LIGHT FOOT YOU ARE BOTH IN THE
ROOM YOU CAN CAN CHOSE WHO GOES
FIRST.
>>THANK YOU THIS IS A MUCH
NEEDED CONCEPT AND I'M SO HAPPY
TO SEE THIS AND WE KNOW THAT
THERE'S A DIRT DERTH ON INTERVS
FOR PEEL LIVING WITH IF HIV AND
THIS LACK OF HIGH-QUALITY
RESEARCH IT'S DIFFICULT FOR LOW
AND MIDDLE INCOME COUNTRIES AND
ALSO IF YOU CAN ACHIEVE THE
FIRST GOAL THAT GIVES US OPTIONS
AND WHERE HIV IS MOST PREVALENT
AND YOU HIGHLIGHTED THE
DEVELOPMENTAL CONTEXT AND I
THINK THIS IS AN OPPORTUNITY TO
IS LEARN MORE ABOUT CULTURAL
ENVIRONMENTS FOR WHICH THEY'RE
NOT MUCH DATA SO PAYING
ATTENTION TO OH, WHAT ARE THEY
IF YOU THINK ABOUT ADOLESCENTS
IF YOU THINK ABOUT THE EARLY TO
AND HOW THEY'RE IMPORTANT AND SO
I'M THINKING ABOUT WHAT MIGHT BE
SOME OF THE IS RESEARCH AREAS
AND HOW MIGHT THEY BE DESIGNED
TO ADDRESS ADOLESCENTS JOURNEY
THROUGH DISCLOSURE HIV STATUS
AND MANAGEMENT OF TREATMENT
FATIGUE AND SOME OF THE GENDER
SPECIFIC ELEMENTS AND THE OTHER
STRESSORS YOU HIGHLIGHTED AND
WHAT DO WE UNDERSTAND ABOUT
PARENTAL AND CAREGIVER
INVOLVEMENT IN MENTAL HEALTH
INTERVENTIONS AND SOME LIKE
INVOLVE PARENTS OR CAREGIVERS
AND WHAT CAN WE LEARN ABOUT WHEN
AND WHERE TO NOT CORPORATE THOSE
KINDS OF CAREGIVER ROLES AND THE
QUESTION OF DOSING I THINK IS
IMPORTANT SINCE WE SEE ATTRITION
FROM MENTAL HEALTH HEALTHCARE
PARTICULARLY IN SOME OF THE
INTEGRATED SETTINGS AND HIV CARE
AND SO IS THERE A BENEFIT FROM
SINGLE SESSION INTERVENTIONS
ENABLING PEOPLE TO EXPLORE THE
WHOLE GAMUT WOULD BE IMPORTANT
AND FIGURING OUT FOR WHOM.
I THINK THE OTHER ASPECT OF WHAT
I SEEN IN SOME OF THE WORK THAT
WE DO WHEN THE CARIBBEAN IS
OFTEN FIGURING OUT WHAT KINDS OF
INTERVENTION CAN HAVE SYMPTOMS
BECAUSE YOUNG PEOPLE MAY BE MORE
DISTRESSED AND AND WILL NOT BE
ABLE TO BE LINKED TO MENTAL
HEALTH SERVICES.
EXAMING WHO SHOULD DELIVER THESE
FOR YOUNG PEOPLE.
PEER CENTERED OR OTHER PROVIDERS
AND WHAT IS THE CONTEXT.
SHOULD THEY BE OUTSIDE OF THE
CLINIC AND HEALTH AND WHEN YOU
THINK ABOUT JUST INTERVENTION
IT'S GOING TO BE IN THIS CONTEXT
THAT MAY EITHER DISCOURAGE
ENGAGEMENT OR SO I WOULD INCLUDE
SOMETHING ABOUT THAT AND THEN
THE LAST TWO THINGS MAY BE I
THINK AS WE KNOW THERE'S
ATTENTION TO ENGAGING YOUNG
PEOPLE ON THE INTERVENTIONS THAT
ARE DEVELOPED FOR THEM SO MAKING
THAT A REQUIREMENT AND FINALLY I
WOULD SAY, AND I'LL OWING CARING
PEOPLE WITH RESEARCH HIV
PROGRAMS AND ACTUALLY LINKING
THEM TO THE EXISTING MENTAL
HEALTH HEALTH SERVICES AND
DIFFERENT SETTINGS, THANK YOU.
>>I WAS VERY EXCITED TO SEE
THIS.
THERE IS AN INCREDIBLE NEED FOR
MENTAL HEALTH SERVICES FOR YOUNG
PEOPLE AND LMICs.
IT'S HARD TO SEE THIS
ACKNOWLEDGMENT OF THE WORKFORCE
REALITY AND SOME OF THE TASK
SHIFTING THAT MAY NEED TO HAPPEN
FROM MENTAL HEALTH HEALTH
INTERVENTIONS TO USE A NON
PROFESSIONAL WORKFORCE AND IN
ORDER TO DELIVER THIS PLAN OF
WORK AND SO JUST I ALSO WANTED
TO UNDERSCORE WITH Dr. COLLINS
SAID ABOUT THE THE RELATIONSHIP
WITH PARENTS AND HOW THOSE AND
HOW CAREGIVERS ARE INVOLVED AND
THEY HAVE UNITE CHALLENGES AND
THINKING ABOUT HOW THOSE
INTERSECT WITH MENTAL HEALTH AND
CHARGES YOUNG PEOPLE HAVE FACED.
A FEW OTHER THINGS TO CONSIDER.
ONE THING THAT IS RELATED TO
Dr. COLLINS TALKED ABOUT IS
THAT THERE'S NRMIC AND AND
CHARGES TO PROVIDING YOUTH
FRIENDLY SPACES AND IN ORDER TO
PROVIDE CARE SO IT SEEMS PART OF
THAT IS PIECE AROUND WHERE IS
THIS HAPPENED AND THIS YOUTH
FRIENDLY SPACE AND CREATING
PLACES WHERE YOUNG PEOPLE FEEL
COMFORTABLE GOING IS IMPORTANT.
OF THERE'S LIKELY TO BE IS A
LACK OF DOCUMENTING AND AMONG
YOUNG PEOPLE AND THERE ROOM IN
ORDER TO PROVIDE THE OPPORTUNITY
TO DOCUMENT THE NEED AND SCOPE
AND OTHERWISE IT WOULD BE
CHALLENGES AND FOR INVESTIGATORS
TO JUSTIFY AND WRITE THAT
PROBLEM STATEMENT IN THE
RESEARCH TO REVIEW GROUPS.
AND WHILE THEY'RE A FEW
INTERVENTIONS OUT THERE TO
ADJUST MENTAL AND MANY, MANY
MORE WERE NEEDED AND IT'S
EXCITING THIS IS INTENDED TO
JUMP START THAT AREA.
ALTHOUGH THIS STARTS WITH
ADAPTATION AND IT WOULD BE AN
INCREDIBLE CONTRIBUTION.
I'VE TRIED ADAPTING MENTAL
HEALTH CONCEPT S WITH MY NIH NOT
INTERVENTION WORK SO EMOTIONAL
REGULATION SKILLS YOU TALK ABOUT
HEALINGS AND THOSE KINDS OF
THINGS AND THERE'S DEFINITELY
DIFFERENCES IN HOW PEOPLE THINK
ABOUT MENTAL HEALTH, EMOTIONS,
FEELINGS AND SO SOME OF THAT IS
REALLY GOING TO HAVE TO THOUGHT
ABOUT SO THERE'S DISCUSSION AND
FLUENCY AROUND MENTAL HEALTH
SOCIAL MEDIA CULTURAL REL VAN
SEE STARTS WITH THE NEED TO
START WITH CULTURALLY RELEVANT
INTERVENTIONS NOT JUST
CULTURALLY TAILORED BECAUSE
GIVEN THE SCOPE OF THE CHANGES
YOU WERE TALKING ABOUT ARE
NECESSARY IN INTERVENTIONS TO
MAKE THEM RELEVANT FOR LMICs
AND YOU MAY FIND YOU HAVE A
DIFFERENT INTERVENTION THAT
WHERE YOU STARTED AND SO, AN
EXAMPLE OF SOME OF THIS
CULTURALLY RELEVANT OR WE WERE
DOING THIS EMOTIONAL REGULATION
AND OF WE WERE TALKING ABOUT
THEIR FEELINGS AND THEY WERE
LIKE WELL WHAT DO YOU MEAN BY
FEELINGS?
HOW DO YOU NOT TACTILE AS
OPPOSED TO EMOTIONS WHEN WE WE
TALKED ABOUT EMOTIONS IT WAS
CHALLENGING BECAUSE IT'S NOT
SOMETHING THEY TALKED WITH THEM
ABOUT SO, AGAIN, THIS NEED FOR
CUL ACTUALLY RELEVANT
INTERVENTIONS IS GOING TO BE
IMPORTANT AND I WOULD ALSO
ADVOCATE FOR INTERVENTIONS THAT
ARE LOCALLY DEVELOPED AS OPPOSED
TO ONLY FAVORING WESTERN
INTERVENTIONS SO ALLOWING THE
ASSETS TO BE DEPLOYED AND IN
COMMUNITIES AS WE TRY TO ADDRESS
NOT MENTAL HEALTH ISSUES AND
LMICs.
THE PIECE MIGHT BE GOOD TO
REALLY INCLUDE IS THE CAPACITY
OF THE INFRASTRUCTURE SUPPORT
AND SCAFFOLDING NEEDED IN THESE
VARIOUS SETTINGS AND THE LAST
THING I'LL SAY IS REALLY
APPRECIATED HOW THE STRATEGIC
FRAMEWORK FOR ADDRESSING YOUTH
MENTAL HEALTH DISPARITIES TOOK A
PROCEED BROOCH TO UNDERSTANDING
AND I WONDER IF THAT PROCEED
APPROACH MIGHT BE USEFUL HERE
BUT I'M REALLY EXCITED ABOUT
THIS AND REALLY DO HOPE THAT IT
MOVES FORWARD SO THANK YOU FOR
DEVELOPING THIS.
>>THANK YOU SO MUCH.
PATRICIA.
>>THANK YOU FOR THIS PROPOSAL.
I HAD -- I HAVE NO EXPERTISE IN
THIS AREA.
IN ANYWAY YOU COULD CONSTRUE IT
BUT I LOOKED FOR THE IMPACT OF
CONGENITAL HIV AND I WAS
WONDERING -- THEY'RE ONLY LIKE
HALF A DOZEN PAPERS ON THE
BEHAVIORAL ASPECTS OF CONGENITAL
HIV DONE IN ANY SYSTEMATIC WAY
WHATSOEVER AND I WAS WONDERING
IF THIS WAS PART OF YOUR PLAN OR
AN OBSTACLE TO YOUR PLAN OR HOW
YOU WERE GOING TO DEAL WITH IT.
I THINK AS THE HIV EPIDEMIC
CHANGES AND THERE'S BEEN A LOT
OF RAMP UP SERVICES WE'RE SEEING
SOME CHANGES AND THE AT LESS
ENTER HIV EPIDEMIC AND THERE'S
FEWER WITH ADOLESCENTS WHO
ACQUIRE HIV LATER IN LIFE
ALTHOUGH THERE'S DEFINITELY
STILL A GROUP AND IT'S SOMETHING
THAT WILL BE IMPORTANT FOR FOLKS
TO CONSIDER AND THINK ABOUT AS
WELL.
>>SO THANK YOU FOR THIS I
APPRECIATE THE COMMENTS MADE
EARLIER AND WANTED TO KIND OF GO
BACK TO THE MAJOR POINT YOU WERE
MAKING.
HOW DO YOU STREAMLINE SERVICES
SO LOW AND MIDDLE COME INCOME
BACK SO MUCH TO USE THE
SERVICES.
I AGREE WITH THE LOCAL
DEVELOPMENT AND I HAVEN'T DONE
THIS WORK A WHILE BACK AND
THERE'S THE IDEA OF VOLUNTARY
COUPLES INVOLVED IN TESTING
SINCE A LOT OF YOUTH THEMSELVES
ARE ENGAGE IN A LOT OF WAYS AND
THE BIG PIECE OF THAT IS ALSO
MADE INVOLVEMENT BECAUSE A LOT
OF THE SERVICES AS YOU KNOW, IN
TERMS OF THE OTHER AREAS OF
TAKERS THAT IS MOSTLY I THINK
WHATEVER IS DONE, MAYBE SOME
EMPHASIZE ON MALE INVOLVEMENT
PARTICULARLY MALE PARTNERS IS
CRITICAL TO THE PROCESS IT'S
SELF AND THE IDEA OF THE
SCREENING IS WHAT I'M LOOKING
AT.
SCREENING FOR HIV AND MENTAL
HEALTH SERVICES AND THAT MIGHT
BE NEEDED THERE.
THERE'S THE WHOLE CHALLENGE OF
WORKFORCE ADEQUACY AND QUALITY.
WHO IS GOING TO DELIVER THIS.
I APPRECIATE THAT APPEAR
DELIVERY SYSTEM WOULD BE GOOD
HOWEVER THEY'RE NOT THE DECISION
MAKERS AND THE BIG PICTURE AND
THEY'RE NOT THOSE MOST LIKELY
THAT WILL WRITE THE PROPOSALS
AND GET THE GRANDS TO DO THIS SO
IT'S CRITICALLY IMPORTANT THAT
WHATEVER YOU DO, MY STRONG
SUGGESTION IS TO MAKE SURE
THERE'S IS SOME CLEARANCE OF
ADEQUACY IF NOT THEN SOME
SUPPORT FOR CAPACITY BUILDING TO
INVOLVED IN WHATEVER WORK THAT
YOU HAVE AS YOU KNOW PARTICULAR
IN THESE SETTINGS AND THAT IS
GOING TO BE A CHALLENGE IN ALL
KINDS OF DIFFERENT WAYS AND THE
LAST THING I WOULD SAY IT'S METH
LOGICAL APPROACH TO THIS AND ONE
OF THE THINGS WE LEARNED A VERY
LONG AGO IS THAT WE NEED MORE OF
A MIXED METHODOLOGY BOTH MIXED
DATA AND METHOT AS AN APPROACH
TO DEAL WITH THIS PARTICULARLY
BECAUSE OF THAT I WOULD SAY
GIVEN THE COUNTRIES YOU ARE
LOOKING AT WHERE A LOT OF THEM
ARE UNDER 30 AND SO THANK YOU
FOR THIS.
>>THANK YOU.
GO AHEAD.
JUST SOMETHING ELSE TO CONSIDER
WHICH IS, ARE YOU REALLY SEEKING
RESEARCH ON ANY LOW OR MIDDLE
INCOME COUNTRY OR MIGHT YOU NEED
A MORE DESCRIPTIVE REFERENCE TO
WHAT CONTEXT YOU ARE LOOKING FOR
AND ARE YOU LOOKING FOR PLACES
WITH HIGH MY PREVALENCE?
I THINK WE START TO USE LMICs
IN A WAY THAT DOESN'T
NECESSARILY MEAN SOMETHING AND
THERE MAY BE OTHERS THAN WORLD
BANK INCOME GROUPS THAT GET THE
KIND OF RESEARCH THAT YOU MIGHT
WANT AS YOU PREPARE FOR THAT.
>>THANK YOU.
>>DO YOU HAVE ANOTHER QUESTION?
OF ANYONE ELSE?
>>OKAY.
FANTASTIC.
THANK YOU SO BOB, MIKE AND TERRY
AND THANK YOU ALL FOR YOUR
COMMENTS.
WE'RE A LITTLE AHEAD OF SCHEDULE
BUT WE CAN MOVE ON, RIGHT.
WE'LL DO A COMPUTER SWAP.
ARE SO CONTINUING OUR SLIGHTLY
OUT OF ORDER AGENDA FOR THE DAY
I WILL INTRODUCE OUR NEXT
SESSION THAT FOCUSES ON
IMPLEMENTATION OF THE NIH DATA
MANAGEMENT AND SHARING POLICY.
SO WE HAD A BRIEF DISCUSSION OF
THE NIH DATA MANAGEMENT SHARING
POLICY WHICH WENT INTO EFFECT
JANUARY 25th OF THIS YEAR AND
WE INVITED CREDIT DANIELSON AND
FROM THE NIH OFFICE OF
EXTRAMURAL RESEARCH AND TO
DISCUSS EVERYTHING ABOUT THE I
AMMENTED DATA MANAGEMENT SHARING
POLICY INTO ANSWER ANY QUESTIONS
THAT YOU MIGHT HAVE.
WE'RE ENCOURAGING YOU TO MAKE
THE MOST OF THE TIME WITH THEM
BECAUSE I'M SURE THAT MANY OF
YOUR COLLEAGUES AND THE RESEARCH
COMMUNITY ARE HOPING THAT YOU
WILL ASK ALL OF THE QUESTIONS
AND HAVE THIS ALL FIGURED OUT BY
THE TIME YOU LEAVE MEETING.
NIH HAS POSTED MANY GREAT
RESOURCES TO HELP GUIDE YOU AND
THE IMPLEMENTATION OF THIS
POLICY SO IF BEER READY, Dr.
DANIELSON AND SLEUTHMAN, THANK
YOU FOR BEING HERE.
WELCOME.
>>THANK YOU, VERY MUCH.
WHAT WE'RE HOPING TO DO DURING
THIS TIME WITH YOU IS TO GIVE
YOU A LITTLE BIT OF A BACKGROUND
ABOUT THE RATIONALE HOPEFULLY
THIS IS A LITTLE BIT BETTER.
IT SAYS IT'S ON BUT LET ME KNOW
IF I NEED TO SPEAK A LITTLE
MORE.
OUR PLAN IS TO GIVE YOU A BETTER
SENSE OF THE POLICY AND THE
REQUIREMENTS AND THE RATIONAL
AND THE PART OF DEVELOPING THE
POLICY AND THE TIMING OF THE
POLICY AND HOW WE'RE
IMPLEMENTING THE POLICY IN A
PARTICULAR HOW WE'RE LEARNING
FROM THE RESEARCH COMMUNITY AND
AS WE DO SO, AND THEN JUST SHARE
WITH YOU SOME RESOURCE THAT'S WE
HAVE AND SITUATE THE DISCUSSION
ABOUT DATA SHARING IS PART OF A
CULTURE CHANGE FOR NIH AS ONE OF
MANY FACTORS WITH CRITICAL ROLES
TO PLAY.
OIR FOCUS IS ON THE 2023 DATA
MANAGEMENT SHARING POLICY
HOWEVER THIS POLICY IS THE MOST
RECENT ONE IN A BROAD ECOSYSTEM
OF OF THE DMA POLICY REQUEST
RESISTS IN AN ECOSYSTEM WITH
OTHER POLICIES INCLUDING THE
CLINICAL TRIALS INFORMATION
POLICY AND NEXT SLIDE, PLEASE.
IN ADDITION TO THE POLICIES I
JUST MENTIONED THAT ARE CONVINCE
IMAGES TO USE THE AND PROGRAMS
MAY HAVE MANAGEMENT SHARING
POLICIES TO HELP PROVIDE AND
GUIDE APPLICANTS TO PARTICULAR
REPOSITORY AND THE BROADEN THE
SCOPE OF THE KINDS OF THIS IS A
SAMPLING OF POLICIES AND ICs
THAT HAVE EXISTING POLICIES
INCLUDING NIMH.
SO WHY IN THIS BROAD ECOSYSTEM
WITH MANY POLICIES FOR RESEARCH
AND INSTITUTIONS TO RESPOND TO
AND BE COMPLIANT WITH NIMH
ROLLED OUT A NEW DATA SHARING
POLICY.
RESEARCHERS HAVE TRIED TO
REQUEST BASED ON POLICY AND
PUBLICATIONS AND ACCESS TO
PUBLICATIONS AND WHAT WHAT IS
COMMON IS THE RATE OF ACTUALLY
RECEIVING BACK DATA THAT WAS
SAID TO BE SHARED PRODUCE
STUDIES DESPITE THE EXISTENCE OF
MULTIPLE SHARING POLICIES.
NEXT SLIDE, PLEASE IN ADDITION
TO CHARGES FOR RESEARCHERS AND
ACTIVE COMMUNITY AND ACCESSING
EXISTING DATA, ACCESS TO DATA
AND AVAILABILITY OF ESTIMATE AND
SO THIS SLIDE SHOWS DATA FROM A
FEW RESEARCH STUDY WHICH ASKED
MEMBERS OF THE PUBLIC WHAT OUR
FACTORS IN ENHANCING THE TRUST
OF SCIENTIFIC DATA AND THE
FACTOR THAT THE GREATEST PORTION
OF THOSE RESPONDING TO THE
SURVEY SPENDED TO 57% IS THE
DATA IS OPENLY AVAILABLE TO THE
PUBLIC SO AGAIN UNDER SCORING
THE NEED FOR REALLY ROBUST AND
MEANINGFUL OF PRACTICES FOR DATA
SHARING.
NEXT SLIDE, PLEASE.
IT INVOLVED MANY GROUPS INVOLVED
TITLE CONSULTATIONS AND IT
INVOLVED FEEDBACK FROM SOME
EXISTING COMMITTEES FOCUSED ON
PROTECTION AND INCLUDING THE
SECRETARIES ADVISORY COMMITTEE
FOR HUMAN RESEARCH PROTECTION
AND OTHER AGENCIES.
THE POLICY ITSELF WAS RELEASED
AND PUBLISHED IN 2020 AND WENT
INTO EFFECT ON JANUARY 25th,
2023.
THE FIRST OF THESE IS TO ADVANCE
IT IT'S RESTORATIVE DATA AND
RESEARCH PUBLIC TRUST IN
RESEARCH FOR A NUMBER OF
REASONS.
S IS LET ME TELL BUT THE SCOPE
AND THE POLICY.
THE POLICY REALLY HAS ONLY TO
REQUIRE THEY SUBMIT A DATA
MANAGEMENT AND SHARING PLAN IS
AND THE DEFINITION OF WHAT IS
MEANT BY SCIENTIFIC DATA AND
WITH FACTUAL QUALITY TO VALIDATE
REPLICATE RESEARCH FINDING AND
THIS IS REGARDLESS OF WHETHER
DATA UNDERLIES PUBLICATIONS OR
WEATHER DATA IS NOT USED IN
PUBLICATIONS AND IMPORTANTLY
WHAT THE SCOPE DOES NOT INCLUDE
IS OTHER DATA AND PHYSICAL
OBJECTION INCLUDING BIO SIS ONLY
TO DATA.
THE POLICY ALSO DESCRIBES TIME
LINES FOR SHARING DATA AND SO
DATA IS REQUIRED TO BE SHARED NO
LATER THAN THE DATE OF PUB WILL
INDICATION FOR A PRIMARY WILL
YOU BE LA INDICATION OR THE END
OF THE PERFORMANCE PERIOD FOR
DATA THAT DOESN'T UNDERLINE
PUBLICATIONS WHICH EVER OF THOSE
TWO POINTS IN TIMES COMES FIRST.
IT ALLOWS A LOT OF FLEXIBILITY
WITH REGARD TO HOW LONG DATA
SHOULD BE SCARED AND MAINTAINED
AND REALLY ENCOURAGING
RESEARCHERS TO CONSULT WITH ZOO
OTHER GROUPS TO THINK ABOUT
OTHER REQUIREMENTS AND
EXPECTATIONS AND JOURNAL
POLICIES, REPOSITORY POLICIES
AND THEIR OWN INSTITUTION
POLICIES FOR MAINTAINING
RESEARCH RECORDS AND DATA.
IT THERE'S MORE INFORMATION
ABOUT WHICH ACTIVITY CODES IN
PARTICULAR THE POLICY IS
APPLICABLE TO.
IN GENERAL THE POLICY APPLIES AS
I SAID, TO RESEARCH THAT
GENERATES SCIENTIFIC DATA SO
RESEARCH PROJECTS, AND SMALL
BUSINESS AWARDS AS WELL.
THERE'S A DETAIL LISTING OF ALL
ACTIVITIES CODES SO IT'S
POSSIBLE FOR APPLICANTS TO LOOK
AT THE PARTICULAR ACTIVITY CODES
WHICH THEY'RE CONSIDERING TO
UNDERSTAND THE POLICIES
APPLICABLEAPPLICABILITY.
IT'S ADDITIONAL EXPECTATIONS FOR
DATA MANAGEMENT AND SHARING
PLANS.
SO THE FIRST SO PLANS SHOULD
OUTLINE SHARING AND OUTLINE HOW
PROTECTION OF PRIVACY RIGHTS AND
CONFIDENTIALITY AND MAINTAINED
AND DESCRIBE ANY EXISTING LAWS
OR REGULATIONS THAT MIGHT APPLY
AND IT MIGHT LIMITS TO DATA
SHARING.
THINKING ABOUT WHAT INFORMATION
IS CONVEYED AND WHAT WE SHARED
AND SECONDARY DATA SHARING AND
ADDITIONALLY, THE POLICY AT NIH
ENCOURAGES INVESTIGATORS TO
THINK ABOUT THEIR PLANS FOR DATA
SUBMISSION AND WHAT ARE THE
REPOSITORIES AND THE PROTECTIONS
IN THOSE REPOSITORY FOR OTHER
LOCATIONS FOR RESTORING DATA AND
WITH REGARD TO CONTROLS FOR DATA
ACCESS SO DATA SHOULD BE STORED
ISTORED IN A CONTROLLED FASHION
AND THINKING THROUGH IN A
THOROUGH WAY THAT WE HAVE PLANS
FOR SUBMITTING AND STORING DATA.
THE POLICY ALLOWS FOR
APPROPRIATE ETHICAL AND LEGAL
ASK TECHNICAL FACTORS FOR
ELIMINATION OF DATA AND WE HAVE
A FREQUENT ASKED QUESTIONS ABOUT
RESOURCES TO SUPPORT APPLICANTS
AND COMPLY WITH THE POLICY THAT
GETS SPECIFIC EXAMPLES OF WHAT
FACTORS NIH HAS IN MIND SO THESE
EXAMPLES INCLUDE, OBVIOUSLY THIS
IS MY COMPREHENSIVE SITUATIONS
WHERE THEY WILL NOT PERMIT OR
HAS ON THE SCOPE OF DATA SHARING
AND DATA REVIEWS AND
ADDITIONALLY, OTHER EXISTING FED
CAL STATE TRAVEL LAWS OR
REGULATION STATE LAWS AND THE
PARTICULAR CONCEPT DISCLOSURE OR
SHARING BUT ALSO THE LEGAL
FACTORS FOR LIMITING DATA USE.
THE KINDS OF REASONS THAT
CURRENT CONSIDERED TO BE
JUSTIFIABLE FOR LIMITED DATA
SHARING INCLUDE CONSIDERATIONS
THAT MAY BE A DATASET IS TOO
SMALL TO BE OF VALUE AND
RESEARCHERS THINK THAT THE DATA
MAY NOT BE USEFUL TO
COLLABORATORS AND THERE'S NOT AN
APPROPRIATE REPOSITORY FOR
MOUSING THE DATA SO THOSE ARE
EXISTED AND OUR THOUGHTS TO BE
JUSTIFIABLE AND I WILL MENTION
THAT WE DO HAVE A GUIDE THAT
TALKS ABOUT SELECTION OF ROBUST
REPOSITORY AND CHARACTERISTICS
AS WELL AS A NUMBER OF RESOURCES
ON THE SHARING AT NIH.GOV
WEBSITE WITH EXPEL OF OTHER
SPECIALIST GENERALIST
REPOSITORIES.
WE HAVE A NUMBER OF FAQs AND
RESOURCES FOR SUPPORTING
APPLICANTS AS THEY PREPARE PLANS
AND COMPLY WITH THE POLICY AND
WE HAVE A LARGE NUMBER OF FAQs
AND POLICIES INCLUDING ONE AREA
NA IS NOT AND IT'S BUDGET SO WE
RECEIVED MANY QUESTIONS ABOUT
HOW TO CONSIDER AND BUDGET FOREL
POLICY AND HAVE 13FAQs RELATED
TO THAT AS WELL SO I ENCOURAGE
YOU TO EXPLORE THE SHARING
WEBSITE AND CONSIDER THESE IN
DEVELOPING DATA MANAGEMENT AND
SHARING PLANS.
NEXT SLIDE, PLEASE.
SO, VERY BRIEFLY JUST TO GIVE A
FLAVOR OF HOW THE POLICY IS
BEING IMPLEMENTED AND WHAT THE
WORKFLOW LOOKS LIKE FOR
APPLICANTS AS THEY PUT TOGETHER
A DATA MANAGEMENT PLAN AS PART
OF THEIR APPLICATIONS.
WHAT THE APPLICATION, THE DATA
MANAGEMENT AND PLAN IS
SUBMITTED, ADDITIONALLY, A BRIEF
BUDGET JUSTIFICATION IS ALSO
SUBMITTED.
PEER REVIEWERS WILL NOT HAVE
ACCESS TO THE DATA MANAGEMENT
AND SHARING PLAN ITSELF, THEY
WILL SEE THE BRIEF BUDGET
JUSTIFICATION AND THE BUDGET
THAT'S PROVIDED.
THE ASSESSMENT OF DATA
MANAGEMENT SHARING PLANS IS
RESPONSIBILITY OF NIH PROGRAMS
STAFF.
OF IN THE APPLICATION,
SUBMISSION AND REVIEW PROCESS AS
WELL AS DURING THE LIFE CYCLE OF
THE AWARD.
OF THE CONTENT OF THE DMS PLANS
ARE IN THE TERMS OF CONDITIONS
OF THE AWARD AND NIH STAFF WILL
MONITOR COMPLIANCE OF THE PLANS
AT WEG REPORTING INTERVALS
ANNUALLY.
FINALLY, A COMPLIANCE OR LACK
THERE OF MAY FACTOR INTO FUTURE
DIVISIONS AND I'LL TURN THE
PRESENTATION OVER TO Dr.
DANIELSON.
>>THANK YOU, NEXT SLIDE,
PLEASE.
>>SO CONTINUING WITH THE PUBLIC
ENGAGEMENT WE HAVE CONTINUED
THAT IN TERMS OF IMPLEMENTATION
OVER THE LAST COUPLE OF YEARS
AND ENGAGING IN PUBLIC OUTREACH
AND EDUCATION.
AND THIS IS REALLY A TWO-DAY
CONVERSATION SO WE'RE PROVIDING
INFORMATION AND RESOURCES TO
HELP PREPARING THE COMMUNITY FOR
THIS POLICY AND ALSO TO HEAR THE
QUESTION AND FEEDBACK AND ON
THIS SLIDE HERE YOU ARE SEEING A
SELECTION OF RECENT
PRESENTATIONS AND GIVEN TO
VARIOUS GROUPS AND SO
INSTITUTIONS, RESEARCHERS,
SCIENTIFIC ASSOCIATIONS AND AS
WELL AS OTHER GROUPS, AND WE'RE
ALSO WANTING TO HIGHLIGHT
SPECIFIC EVENTS WITH A LARGER
REACH AND RECENTLY THAT WAS THE
NIH GRANTS CONFERENCE AND WHERE
NOT WE REACHED OVER 2,000
ATTENDEES OF THE LIVE SESSION
AND THEN THIS PAST SUMMER, WE
HAD A MORE EXTENSIVE TWO-PART
WEBINAR SERIES JUST FOCUSING ON
THIS POLICY AND COVERING THE
NUMBER OF TOPICS AND QUESTIONS
THAT WE SEE DURING THOSE
SESSIONS.
HAD SO THIS OUTREACH HAS ALLOWED
US TO HEAR FIRSTHAND WHERE THE
COMMUNITY SEES THE NEED FOR
ADDITIONAL RESOURCES.
AND WE REALLY ARE IN LEARNING
MODE WHILE THIS POLICY IS SO NEW
AND WE'RE MAKING SURE TO BE
RESPONSIVE TO THE COMMUNITY WITH
WHAT THEY SEE AS ADDITIONAL
NEEDS TO BE PREPARED FOR THIS
POLICY.
AS SAN EXAMPLE OF THAT IN
RESPONSE TO FREQUENT QUESTIONS
ABOUT WHAT FORMAT SHOULD BE USED
NIH CREATED AN OPENINGAL FORMAT
PAGE TO GIVE PEOPLE SOMEWHERE TO
START AND IN TERMS OF THE FORMAT
PAGE IT ALLOWS WITH THE ELEMENTS
OF A DMS PLANS THAT WAS
PUBLISHED ALONGSIDE THE POLICY
ITSELF, IT SPLITS IT UP TO HELP
WITH DIFFERENT PIECES OF
INFORMATION THAT MIGHT BE
RELEVANT TO OF COVERING THE MANY
DIFFERENT AREAS OF SCIENCE AND
NIH SUPPORTS AND WE WANT TO
LEARN WHAT WORKS BEST FOR
DIFFERENT SCIENCE AND PROJECTS
AND AND WE ARE LEARNING FROM THE
COMMUNITY IS BY ENGAGING IN A
PILOT PROJECT WITH THE FED CAL
DEMONSTRATION PARTNERSHIP TO
TEST OUT DIFFERENT APPROACHES
NEXT SLIDE, PLEASE.
SO THROUGH A COLLABORATION
BETWEEN THE FDP AND NIH THIS
PILOT PROJECT IS TESTING THE
EFFECTIVENESS AND USABILITY OF
TWO TEMPLATES FOR DMS PLANS AND
ONE PART IS GETTING FEEDBACK
FROM THE RESEARCHER AND FACULTY
PERSPECTIVE FROM THOSE
DEVELOPING THESE PLANS AND ALSO
GETTING FEEDBACK FROM THE NIH
PROGRAM PROSPECTIVE AS THEY'RE
THE RUNS TO ASSESS THESE PLANS
AND THIS PROJECT IS JUST KICKED
OFF RECENTLY AND WE'RE REALLY
LOOKING FORWARD TO GETTING MORE
INFORMATION AND IS TAKING THIS
INTO ACCOUNT AS WE LOOK AT WHAT
RESOURCES AND CHANGES MIGHT BE
NEEDED IN THE FUTURE.
THERE'S A SECOND FACE OF THE FDP
PILOT THAT WILL FOCUS ON COST
AND THIS KEEPS IN MINDS
QUESTIONS WE'VE BEEN HEARING
FROM THE COMMUNITY AND AS THEY
CONSIDER WHAT TYPES OF COSTS ARE
REQUIRED TO MANAGE AND SHARE
THEIR DATA AND ACCORDANCE WITH
THE PLANS OF THEIR DEVELOPING.
NEXT SLIDE, PLEASE.
ANOTHER EXAMPLE OF LISTEN TO GO
THE COMMUNITY TO HELP TARGET OUR
IMPLEMENTATION EFFORTS IS SAMPLE
PLANS.
AND THEY HAVE BEEN COMPLETED FOR
EDUCATIONAL PURPOSES HOW SUCH A
PLAN COULD BE COMPLETED IN
DIFFERENT CONTEXT AND OF COURSE
IT'S NOT A ONE-SIZE-FITS-ALL,
TYPE OF FORMAT IT REALLY WILL
VARY DEPENDING ON WHAT TYPE OF
SCIENCE YOU ARE CONDUCTING AND
WHAT TYPE OF DATA YOU ARE
GENERATING AND WE HAVE NOW
NUMBER OF PLANS THAT ARE HELPFUL
RESOURCE TO TAKE A LOOK AT AND
SEE HOW THIS MIGHT BE DONE AND
SO WE'RE VERY GRATEFUL TO OUR
COLLEAGUES WHO HAVE LED THE WAY
HERE AND THEY DEVELOPED THE
FIRST BATCH OF NIH SAMPLE PLAN
SPECIFIC TO THE AREAS OF SCIENCE
AND TYPES OF DATA COMMONLY
GENERATED THROUGH SUPPORT AND
SINCE THEN WE'VE ADDED SAMPLE
PLANS FROM OTHER NIH INSTITUTES
AND CENTERS SO WE ARE HAVING A
RANGE OF DIFFERENT EXAMPLES TO
HELP RESEARCHERS THINK ABOUT
WHAT MIGHT MAKE SENSE FOR THEIR
PROJECTS.
ANOTHER AREA WHERE OUR NIH
COLLEAGUES AND INSTITUTES AND
CENTERS HAVE BEEN PROVIDING
ADDITIONAL RESOURCES RELATES TO
WHERE TO SHARE DATA.
AGAIN THIS IS AN AREA THAT'S
GOING TO VARY DEPENDING ON YOUR
RESEARCH AND DATA THAT YOU
GENERATING X SO THE DATA
MANAGEMENT AND SHARING POLICY
DOES NOT PRESCRIBE THE USE OF
ANY TECH REPOSITORY OR EVEN
REPOSITORIES BUT IT DOES
STRONGLY ENCOURAGE THE USE OF A
ESTABLISHED REPOSITORY BECAUSE
IT IMPROVES THE FAIRNESS OF THE
DATA SO THE FINDABILITY,
ACCESSIBILITY, AND
INTEROPERABILITY AND
REUSABILITY.
RATHER THAN POINTING TO TECH
REPOSITORIES, NIH HAS PROVIDED
CHARACTERISTICS TO LOOK FOR TO
HELP IDENTIFY SUITABLE
REPOSITORY AND THERE ARE EFFORTS
UNDERWAY WHICH I WON'T GET INTO
THE DETAILS OF TODAY, BUT FOCUS
ON HELPING THE STRENGTH AND THE
REPOSITORY LANDSCAPE TO ENSURE
THEY ARE SUITABLE REPOSITORIES.
THIS IS AN AREA WITH FLEXIBILITY
AND THEY MAY THROUGH INFORMATION
AND SPECIFIC FUNDING
OPPORTUNITIES DESIGNATE TO
PROVIDE ADDITIONAL AND SPECIFIC
EXPECTATIONS RELATED TO DATA
SHARING AND NIMH IS A LEADER IN
THE SPACE AS WELL OFFERING DATA
SHARING INFORMATION OR THE NIH
NOT FUNDED COMMUNITY.
SOME EXAMPLES ARE USE OF
DESIGNATED REPOSITORIES SUCH AS
THE ARCHIVE AND USE OF COMMON
DATA ELEMENTS AND SPECIFIC DATA
SUBMISSION SCHEDULES.
AND THEY HAVE BEEN PROVIDING
RESOURCES INCLUDING SAMPLEDEL
EMS PLAN AS WELL AS A COST NOT
TOOL FOR THE DATA ARCHIVE AND
WE'VE BEEN VERY GRATEFUL FOR THE
LEADERSHIP AND SUBJECT MATTER
EXPERTISE AND DATA SHARING THEY
HAVE BEEN PRESENT IN NIH WIDE
GROUPS FOCUSED ON THE DATA
MANAGEMENT AND SHARING POLICY
IMPLEMENTATION AND RELATED
ACTIVITIES.
NEXT SLIDE, PLEASE.
THERE'S A SCREEN SHOT OF THE
DATA SHARING WEBSITE.
SO IN TERMS OF RESOURCES, I'M
GOING BACK TO CENTRAL NIH
INFORMATION AND WE WANTED TO
POINT OUT WHERE YOU CAN FIND
ADDITIONAL INFORMATION ON
SHARING.
BEV A SCIENTIFIC DATA SHARING
SITE.
AND THIS COVERS MULTIPLE SHARING
POLICIES INCLUDING THE DATA
MANAGEMENT SHARING POLICY AND
LINKS OUT TO MORE INFORMATION ON
NIH INSTITUTE AND CENTERS
SPECIFIC EXPECTATIONS AND THIS
IS UPDATED AS ADDITIONAL
RESOURCES BECOME AVAILABLE SO IT
WILL ALWAYS SERVE AS A CENTRAL
ACCESS POINT.
AND IN TERMS OF PROVIDING
RESOURCES ON PLANNING AND
BUDGETING WHEN IT IT COMES TO
THE DATA MANAGEMENT AND SHARING
POLICY THE WEBSITE COVERS
INFORMATION TO INCLUDE WRITING A
PLAN AS WELL AS INFORMATION
ABOUT WHAT TYPES OF COSTS MAY BE
REQUESTED WHEN BUDGETING FOR THE
ACTIVITIES DESCRIBED IN YOUR
PLAN.
NEXT SLIDE, PLEASE.
SO DURING OUR OUTREACH
PRESENTATIONS, WE LIKE TO SEND
PEOPLE OFF WITH SOME CONCRETE
STEPS THEY CAN TAKE FOR
PREPARING FOR THE DMS POLICY AND
PERHAPS YOU OR YOUR COLLEAGUES
HAVE DONE SOME OF THESE.
SO, ONE THING IN ADDITION TO THE
NIH PROVIDED RESEARCHES WHICH
WE'RE COVERING TODAY, A NUMBER
OF INSTITUTIONS MIGHT HAVE
EXISTING RESOURCES AND COULD BE
VERY HELPFUL WHEN YOU ARE
CONSIDERING THE BEST WAY TO
MANAGE AND SHARE YOUR DATA AND
PARTICULAR DATA LIBRARIANS ARE
AN EXCELLENT RESEARCH THAT THEY
ARE AVAILABLE TO YOU.
AND HE ENCOURAGE TO LOOK AT THE
RELEVANT SAMPLE PLANS NOT SO THE
PLANS ARE AN EXCELLENT RESEARCH
THAT YOU HAVE AVAILABLE TO SEE
HOW THESE PLANS MIGHT BE
DESCRIBED.
TO DRY DRAFTING THE PLAN
YOURSELF EVEN IF YOU DON'T NEED
ONE YET.
JUST A GOOD IDEA TO KIND OF GET
SOME PRACTICE TO SEE WHETHER YOU
ARE PRACTICES, YOUR DATA SHARING
PRACTICES MIGHT NEED TO CHANGE
AT ALL.
YOU'VE BEEN SUBJECT TO OTHER
POLICIES AND GUIDELINES COMING
FROM FUNDERS AND TAKE A LOOK AT
WHAT YOU'VE BEEN DOING AND SEE
WHETHER ANY CHANGES ARE NEEDED
WITH THIS NEW NIH POLICY.
AND THEN FINALLY, WHEN YOU ARE
APPLYING WE ENCOURAGE YOU TO
READ THAT CAREFULLY BECAUSE
THERE MIGHT BE ADDITIONAL
PROGRAMS SPECIFIC NOT DATA
SHARING REQUIREMENTS FOR
INSTRUCTIONS THAT YOU NEED TO
TAKE INTO ACCOUNT.
NEXT STEMS FOR US WE ARE
PLANNING ON EVALUATION OF THE
DMS POLICY AND AGAIN WE ARE
REALLY IN LEARNING MODE HERE AND
IT'S A PRIORITY FOR US TO
UNDERSTAND NOT ONLY THE IMPACT
OF POLICY AND ALSO
IMPLEMENTATIONS WHAT IS WORKING
ADDITIONAL INFORMATION MIGHT BE
NEEDED.
AND SO NIH LEADERSHIP HAS
DESCRIBED PREVIOUSLY IN VARIOUS
BLOGS AND PUBLICATIONS, IS THIS
AIMS TO BRING ABOUT A CULTURAL
NIST RESEARCH SO INTEGRATING
DATA SHARING AS A FUNDAMENTAL
PART OF THE CONFLICT OF SCIENCE
AT NIH WE HAVE ONE LARGE TO PLAY
HERE BUT BEYOND OUR NIH SPECIFIC
IMPLEMENTATION ACTIVITIES, THIS
REALLY IS GOING TO BE A
COLLABORATION ACROSS THE ENTIRE
RESEARCH ECOSYSTEM SO WE HAVE
BEEN PARTICIPATING IN
CONVERSATIONS OTHER RELEVANT
PARTIES AND PUBLISHERS AND
RESEARCHERS AND INSTITUTIONAL
OFFICIALS AND PROFESSIONAL
ORGANIZATIONS ON THE TOP OF
INCENTIVIZING DATA SHARING
ACROSS THIS BIOMEDICAL
ECOSYSTEM.
NEXT SLIDE, PLEASE.
FOR THE LAST SLIDE WE WANT TO
LEAVE YOU WITH WHERE YOU CAN GO
FOR MORE INFORMATION.
THE SHARING WEBSITE IS THE HOME
TO ALL OF OUR RESOURCES ON THE
DATA MANAGEMENT AND SHARING
POLICY AND WE HAVE A DEDICATED
E-MAIL BOX FOR ANY QUESTIONS
FROM THE COMMUNITY SHARING AT
NIH.GOV AS WELL AS A SEPARATE
E-MAIL BOX NOR BUDGET OR COSTING
QUESTIONS SPECIFICALLY.
WE HAVE TIME FROM QUESTIONS FOR
YOU SO THAT'S THE END OF OUR
PRESENTATION AND WE'RE HAPPY TO
TAKE QUESTIONS OR COMMENTS.
>>THANK YOU SO MUCH.
OKAY, MARGARITE A.
>>THANK YOU SO MUCH FOR THIS
PRESENTATION.
THAT WAS A LOT OF REALLY GREAT
INFORMATION.
ONE QUESTION THAT I HAVE, ONE
THING I -- THOSE DOING
QUALITATIVE RESEARCHES, HOW DO
THEY MAKE THAT JUSTIFICATION FOR
LIMITING SHARING AS A DATA AND I
WONDER IF YOU COULD SHARE WHO
AND HOW ARE THOSE DECISIONS
MADE?
OF I MEAN, MAYBE I'LL JUST START
SO YOU HAVE A SPECIFIC QUESTION
ABOUT A CERTAIN TIME OF IS AND
IT ALLOWS THE RESEARCHERS AND
THOSE ARE PROPOSING THE
APPROACHES THAT MAKE SENSE FOR
THEIR DATA IT'S BALANCED WITH A
NUMBER OF FAQs AND ADDITIONAL
RESOURCES FOR TO HELP YOU MAKE
THOSE DECISIONS.
I DON'T KNOW IF YOU WANT TO
POINT OUT ANY SPECIFIC RESOURCES
ON THAT QUESTION.
IT MIGHT BE USEFUL.
>>SPECIFIC, JUST TO CLARIFY IT
WAS INTERESTED IN WHO IS THE
PERSON WHO A PROVES?
WE CAN COME UP WITH A PLAN BUT
APPROVERS, HOW ARE THEY MAKING
THOSE DECISION AND WE WANT TO
COME UP WITH A PLAN THAT
ADDRESSING THE CONCERNS THAT THE
PEOPLE ARE APPROVING.
OF THE PROGRAM OFFICER NAMED ON
THE NO FOE WILL MAKE THAT
DECISION AND THERE'S CERTAINLY
OPPORTUNITIES FOR A VISION BOTH
DURING THE JUST IN TIME PROCESS
AND THE RESEARCH CHANGE DATA
MANAGEMENT AND SHARING PLANS CAN
CHANGE TOO AND I DID WANT TO
ACKNOWLEDGE WE HAVE RECEIVED THE
QUESTION OF QUALITATIVE DATA AND
IT'S CHALLENGING TO THINK ABOUT
HOW TO PROTECT PRIVACY AND
SHARING THAT DATA AND MAKING
THAT ACCESSIBLE SO WE REALIZE
IT'S A DIFFICULT BALANCE AND
THERE ARE DIFFERENT CHALLENGES
ACROSS DIFFERENT KINDS OF
SCIENTIFIC DATA.
>>HELLO.
>>HI, I HAVE A SIMILAR QUESTION
ABOUT A DIFFERENT TYPE OF DATA.
FIRST OF ALL, THANK YOU FOR THE
INFORMATIVE PRESENTATION.
I THINK THE SAMPLE PLANS AND THE
NIH APPROVED REPOSITORIES ARE
GREAT.
RESOURCE.
I DIDN'T SEE HOW DO I MANAGE THE
DATA THAT WE'RE COLLECTING FROM
SMARTPHONES AND WEARABLE DEVICES
AND THAT CAN BE SHARED AT
DIFFERENT LEVELS OF GRANULARITY
AND I'M WONDERING IF THERE ARE
ANY STANDARDS OR EXPECTATIONS
FOR WHAT LEVEL OF DETAILED
GRANULARITY ONE OF THE AREAS
WE'RE HOPING TO LEARN ABOUT WHEN
WE'RE TOGETHER WITH THE
COMMUNITY IS BOTH FROM THIS DATA
WHICH CAN BE.
>>THANK YOU FOR THE
PRESENTATION, I'M STRUCK BY THE
FACT THAT ONE HAS TO BE THINKING
ABOUT THESE ISSUES WHEN YOU ARE
DEVELOPING YOUR SO IN TERMS OF
THE RESOURCES WE HAVE TO HELP
INVESTIGATORS THINKING ABOUT
THESE, NIH RECENTLY SHARED A
POINTS TO CONSIDER DOCUMENT FOR
DEVELOPING INFORMS CONSENT A LOT
OF DIFFERENT FACTORS IS THAT GO
INTO INFORMED CONSENT DOCUMENTS.
WE ALSO HAVE A NUMBER OF
SUPPLEMENTAL NOT MATERIALS THAT
GETS GENERAL BEST PRACTICES OF
THINKING ABOUT PROTECTING
PRIVACY ACROSS DIFFERENT KINDS
OF DATA TYPES AND HUMAN RESOURCE
AND ANOTHER DOCUMENT THAT
FOCUSES ON CONSIDERATIONS WHEN
ENGAGING WITH TRIBAL COMMUNITIES
AND RESEARCH SO THERE ARE GOOD
STARTING POINTS AND I THINK THIS
IS ANOTHER REALLY GOOD EXAMPLE
OF DIALOGUE OF THE CONVERSATIONS
AND HOPEFULLY THAT WILL HAPPEN
IN A COMMUNITY ACROSS DIFFERENT
SCIENTIFIC AREAS TO HELP SHARE
LANGUAGE AND APPROACHES.
>>MATT.
>>THANK YOU.
THANK YOU FOR PRESENTING THIS
AND AS ALWAYS IT'S HELPFUL TO
SEE THE TEMPLATES.
I WANTED TO PUT, SECOND ABOUT
SMARTPHONES AND MONITORING AND
PUTTING A POINT ON A PIECE OF
THIS I'VE HEARD FROM RESEARCHERS
IN THE SI SCIENTIFIC COMMUNITY
DOING WORK WHERE GPS IS
COLLECTED AND THERE'S PRIVACY
CONCERN BECAUSE YOU SEE WHERE
PEOPLE ARE SLEEPING EVERY NIGHT
AND THEY HALT PEOPLE ON CHILDREN
AND PEOPLE AND SUICIDAL BEHAVIOR
AND VIOLENCE AND MENTAL HEALTH
AND DISORDERS AND SO ON THERE'S
CONCERN ABOUT SHARING THE DATA
IN RAW FORM.
I THINK DIFFERENT THINGS FROM
NIH SAYING NO, MUCH SHARE
EVERYTHING RAW IN RAW FORM AND
RESEARCHERS SAYING I DON'T WANT
TO, I'M PROTECTING THE PRIVACY
OF AND THEY EXPECT WE WON'T
SHARE RAW DATA.
IS THIS TO BE A CASE BY CASE
DATA WITH A PROGRAM OFFICER OR
GUIDANCE COMING ABOUT IF THE
DATA IS CERTAIN TYPE.
FOR INSTANCE, THEY'RE
DEFINITIVELY IDENTIFIABLE THEN
THEY'LL BE REQUEST IN SUMMARY
FORM AND PEOPLE ARE THINKING
ABOUT IT AND THEY'RE CONCERNED
ABOUT IT.
SO ANY GUIDANCE IS VERY MUCH
APPRECIATIVE.
THANK YOU.
>>SO I CAN JUST START OFF IN
TERMS OF WHETHER THERE'S A
REQUIREMENT TO SHARE ANY
GRANULARITY OF DATA.
THE POLICY DOES NOT DICTATE
THAT.
IT REALLY DOES ALLOW THAT TO BE
DETERMINED IN TERMS OF WHAT DATA
DO UNDERLYING RESULTS BECAUSE
IT'S REALLY THE FOCUS OF THIS
HERE AND FOR A PARTICULAR
PROJECT IT MIGHT BE THAT PERHAPS
THE MOST USEFUL OR SOME SUMMARY.
NOW OF COURSE THERE MIGHT BE
SPECIFIC FUNDING OPPORTUNITIES
AND THEY CAN INTRODUCE SPECIFIC
EXPECTATIONS THERE AND THEY
MIGHT LAYOUT SOMETHING LIKE THAT
BUT IN GENERAL, IT'S REALLY MORE
OF A CASE BY CASE FOR
DETERMINING WHAT ACTUALLY IS
MAXIMIZING APPROPRIATE DATA
SHARING BECAUSE THAT'S THE
EXPECTATIONS OF THE POLICY
INTRODUCES.
IT DOESN'T REQUIRE YOU SHARE ALL
DATA, IT'S NOT A DIRECT
REQUIREMENT FOR SHARING IT'S
REALLY DETERMINING WHAT IS
APPROPRIATE AND IN SOME CASES IT
MIGHT MEAN LIMITING SHARING OR
SHARING IN A PARTICULAR WAY.
I DON'T KNOW IF YOU HAVE JUST
THINKING OF THE GENOMIC DATA
SHARING POLICY, FOR EXAMPLE,
WHICH IS IN A PLACE FOR A NUMBER
OF YEARS THAT MIGHT BE SOME
RELEVANT LESSON LEARNED HERE IN
TERMS OF WAYS TO SHARE THE DATA
WHEN THERE ARE PRIVACY
CONSIDERATIONS.
>>SO, JUST TO ADD A COUPLE OF
THINGS TO CINDY'S RESPONSE.
AND JUST INQUIRING THAT THE
POLICY EXPECTATIONS AND
REQUIREMENTS SO THE POLICY
EXISTS OF OTHER REGULATION
THAT'S HAVE PROTECTIONS FOR DATA
FOR RESEARCH DATA AND CLINICAL
DATA.
SO, YOU KNOW, THE POLICY DOES
NOT IN ANYWAY SUPERSEDE HIPPA OR
THE FDA PROTECTION REGULATIONS
AND STATE LAWS AS WELL SO I
THINK THAT THERE'S A LOT OF ROOM
FOR RESEARCHERS TO THINK VERY
CAREFULLY IN THE WAY THAT SIGNED
MENTION BESIDES WHAT ARE OUR
APPROPRIATE WAYS TO SHARE DATA
AND FORMATS TO SHARE DATA IN A
WAY THAT PROTECTS PARTICIPANTS,
ESPECIALLY PARTICIPANTS THAT ARE
MEMBERS OF PEDIATRIC COMMUNITIES
AND OTHER VULNERABLE GROUPS.
THE OTHER THING TO ADD AND THIS
IS MENTIONED IN SOME OF THE
CIVIL INFORMATION YOU REFERRED
TO THAT TALK ABOUT ROBUST
REPOSITORY CHARACTER IS I CAN,
MANY SUPPORT REPOSITORIES LIKE
THE GAP WHERE THEY GET IT
COVERED UNDER THE GDS POLICIES
HOUSED HAVE CERTIFICATES OF
CONFIDENTIAL TEE THAT APPLY TO
THEM SO THOSE CAN PROTECT DATA
FROM COMPELLED CLOSURES AND THAT
IS PARTICULARLY, WELL, IF THE
JUDGE, THERE'S A LOT NOT NOT
MORE THAN IS THE INTENT AND
OBVIOUSLY THESE THINGS ARE
NEGOTIATED OUT IN COURT BUT THE
INTENT IS TO HEROINEST THE
PROTECTION OF COCs FROM
DATASETS SO JUST ANOTHER TOOL
FOR INVESTIGATORS TO BE AWARE
OF.
BUT IN THE GENOMIC DATA SPACE,
CERTAINLY REPOSITORIES AGAIN
JUST USING DB GAP AS AN EXAMPLE
WILL DEIDENTIFY DATA WITH
QUALITY CHECKS WHEN DATA SECURE
TO MAKE SURE THAT THERE AREN'T
IDENTIFIERS THAT UNINTENTIONALLY
MAKE IT THROUGH SO I THINK IT'S
ALSO IMPORTANT TO BE THINKING
ABOUT WHEN CONSIDERING WHICH
REPOSITORY DEPOSIT INTO THAT
HAVE ACCESS CONTROLS AND
CREATION AND GIVEN THE KINDS OF
DATA THAT WILL BE DEPOSITED.
>>GREG, I SEE THAT YOU ARE
LINE.
DO YOU WANT TO COMMENT ABOUT
POLICY?
>>YEAH, I JUST WANTED TO JUMP
IN HERE BECAUSE MATT THE
QUESTION YOU RAISED IS ONE THAT
WE'VE BEEN THINKING ABOUT A LOT.
I CAN TELL YOU WHAT OUR CURRENT
PLAN IS IN THE NIMH DATA ARCHIVE
BUT I WANT TO ECHO WHAT CINDY
AND JULIA HAVE SAID THAT WE'RE
ALL LEARNING HERE, RIGHT.
SO, WHAT WE'RE PLANNING ON DOING
WITH THE DATA FROM PERSONAL
TRACKING DEVICES IS THAT ANY
DATA STREAM THAT ACTUALLY HAS
GEO-SPACIAL LOCATIONS WILL BE
SEPARATED FROM THE DERIVED DATA
FROM THE PERSONAL TRACKING
DEVICE.
WE WILL MAKE BOTH DATA STREAMS
AVAILABLE, BUT, IF YOU WANT
GEO-SPACIAL LOCATIONS DATA YOU
HAVE TO PROVIDE US WITH PROOF
THAT YOU ARE IRB HAS APPROVED
NOT.
YOU ACCESSING THAT DATA AND YOU
HAVE HAVE SHOWN THEM THAT UP
APPROPRIATE CONTROLS OVER THE
VERY SENSITIVE DATA.
SO, I THINK THERE ARE PROBABLY
WAYS TO SOLVE THE PROBLEM BUT I
THINK WE'LL LEARN A LOT OVER THE
NEXT 12 MONTHS OR SO.
>>SO THANK YOU FOR THAT
CLARIFICATION, CAN I ASK FOR
FURTHER CLARIFICATION.
WHEN WE GET IRB APPROVAL TO
COLLECT LONGITUDE DATA MAKING
PARTICIPANTS IDENTIFIABLE.
IT SOUNDS LIKE THERE'S AN NIH
EXPECTATION THAT THOSE DATA
WOULD THEN BE SHARED WITH NIH
AND NIH WOULD BE THE DETERMINED
WHO GETS ACCESS TO THE RAW DATA?
>>I DON'T THINK I WOULD GO AS
FAR AS SAYING THERE'S AN NIH
EXPECTATION, I THINK THAT FOR
THE PURPOSES OF NIMH PROGRAM
STAFF, THAT'S NOT HOW WE'RE
HOW WE'RE GOING TOSTART OUT ANDE
THEM AS WE NEED TO BUT YEAH, I
MEAN, YOU KNOW, IT'S SO EASY TO
IMAGINE THAT THE GEO-SPACIAL
LOCATION DATA REAL HE'S COULD
PROVIDE BIOMARKERS FOR THE SORTS
OF, THE SORTS OF DISEASES THAT
WE'RE INTERESTED IN THAT WE FEEL
IT'S QUITE 23508ISH TO SO
FOOLISH TO NOT COLLECT THAT DATA
UNTIL WE KNOW MORE.
>>THE SCHIZOPHRENIA IS THE
FIRST DATASET THAT HAS THIS
INFORMATION MADE AVAILABLE AND
THAT IS GOING TO GO PUBLIC
SHORTLY.
WE'RE TALKING IN A COUPLE OF
MONTHS, THE FIRST VERSION OF IT.
>>I WOULD ENCOURAGE US TO THINK
CAREFULLY AT NIH ABOUT HOW
SENSITIVE THE DATA IS AND THE
POTENTIAL FOR THEM TO BE SHARED
AND ESPECIALLY VULNERABLE MINORS
IDENTIFIED.
>>THANK YOU FOR THOSE COMMENTS,
MATT.
THOSE ARE HEAD.
NOT TED, YOU ARE NEXT AND I HAD
SOME KIND OF BROADER QUESTIONS
AND I'M KIND OF -- I SEE A LOT
OF THE CONVENTION BUT MINE IS
FROM THE PERSPECTIVE OF THE
SCIENTIFIC ENTERPRISE.
AND I'M A LITTLE WORRIED THAT
WE'RE GOING TO WIND UP IN A
SITUATION OF HAVING WATER AND
NOT A DROPPED DRINK WITH A WHOLE
BUNCH OF DATA THAT WE CAN'T MAKE
SENSE OF AND UNDERSTAND AND IN
ANY EXPERIENCE, IN UNDERSTANDING
COMPLEX SCIENTIFIC PAPERS AND
IT'S BEEN ACCESSED TO REAGENTS
AND METHODOLOGY, AND OF FIRSTLY,
SOME OF THAT DATA CAN'T BE
ARCHIVED AND FAIR ENOUGH AND WE
NEED TO FIGURE OUT HOW TO STORE
ALL OF THIS AND WHILE WE THINK
ABOUT STORING THIS, LET'S THINK
IF WE CAN USE IT AND I'M WORRIED
ABOUT THAT.
THAT'S MY GENERAL COMMENT WHICH
DOESN'T HELP IN IMPLEMENTING IT
BUT THERE MAY BE PILOT
INITIATIVES YOU CAN DO.
THERE'S CLEAR DATABASES AND
DATASETS THAT ARE -- I'M NOT A
DATA SIGN TIVE AND BUT THAT
THINKING ABOUT CELL PHONE DATA
AND BEHAVIORAL DATA FROM
SUBJECTS AND GOING TO A GAR
GRAPH AND NO ACTUAL DATA SO YOU
DO A DATA SHARING PLANT AND YOU
HAVE VIDEOS AVAILABLE AND THAT
IN A CASE OF EMERGING
TECHNOLOGIES, LIKE SPACIAL THAT
AREN'T EMERGING ANYMORE YOU HAVE
TO MERGE ALL OF THE IMAGING
DATABASE WHICH ARE HARD ENOUGH
TO GENERATE WITH ALL THE GENE
EXPRESSION DATABASE AND HARD
ENOUGH TO GENERATE AND PUT THEM
TOGETHER.
THERE ARE REAL SPECIFIC, WITHIN
THE NIMH AREAS OF TRACTION THAT
ONE CAN THINK ABOUT AND I'M SURE
MOW BROADLY ACROSS NIH IS THE
CASE AND THINKING ABOUT
INVESTMENTS OF THEM SO WE CAN
ACTUALLY NOT JUST FOR HEALTH BUT
FOR UNDERSTANDING.
SO THAT'S MY GENERAL COMMENT.
IS THINKING ABOUT A PUBLICATION
WOULD BE MAYBE NOT INVALUABLE
BECAUSE IT'S CHANGING AND THE
OTHER THING IN THIS SPACE THAT I
THINK I ACTUALLY REALLY LIKE IS
THE DISRUPTION THAT YOU HAVE AN
OPPORTUNITY TO CAUSE IN THE
SCIENTIFIC COMMUNITY AND THAT IS
THE DISRUPTION IN THINKING ABOUT
THE WORTH OF A SCIENTIST BEYOND
HIS OR HER H INDEX EYESIGHT
NUMBER AND AS WE HAVE DATASETS
AND THINGS WE HAVE TO FIGURE OUT
HOW WE ACKNOWLEDGE THE
CONTRIBUTIONS OF INDIVIDUALS TO
ALL OF THIS ENTERPRISE AND
THAT'S JUST A COMMENT TO SPACE
AS MANY OF MINE HAVE BEEN BUT
THEY'RE IN IMPORTANT
IMPLICATIONS OF THIS AND WHAT IS
TERRIFIC ABOUT ALL OF THIS I
THINK YOU ALL, IT'S GREAT TO SEE
THE THINGS EVOLVE.
IS THE THOUGHT TO EVOLVE THIS SO
THAT THE REVIEW MIGHT EVENTUALLY
BE, THE REVIEW MIGHT BE IN THE
HANDS OF THE VIEWERS OR IS IT
THOUGHT IT WILL STAY WITH THE
PROGRAM.
>>RIGHT NOW THAT DECISION THERE
WAS A LOT OF CONSIDERATION
DURING THE POLICY DEVELOPMENT
PHASE AND AS IT STANDS ON THE
FINAL POLICY THE DECISION WAS
MADE THAT THE PROGRAM STAFF
WOULD BE REVIEWED NOT AND PEER
REVIEWERS SO AS OF NOW, THERE'S
NO PLANS TO CHANGE THAT AND.
>>THANK YOU, THAT WAS A LOT OF
INFORMATION AND I APPRECIATE ALL
THE COMMENTS COMING FROM MY
COLLEAGUES.
I'M GOING TO ACTUALLY SHIFT TO A
VERY SIMPLE PRACTICAL TYPE OF
THING.
ONE OF THE CONCERNS THAT HAS
REALLY GROWN UP IS OUR ABILITY
TO ENGAGE, TRAIN, WORK WITH
PERSONS WHO ARE NEARLY NEW TO
THE WHOLE PROCESS ITSELF.
SO, YOU MAY HAVE MENTIONED IT
AND I APOLOGIZE THE POLL SEC,
METHODOLOGY AND THE ELEMENTS OF
THAT AND THEN THE ACTUAL PERSONS
THEMSELVES ARE THEY WORK WITH
PRE DOCUMENTS AND POSTDOCS AND
WHO ARE JUST BEGINNING AND
WALKING INTO THIS AND THEY HAVE
BACKGROUND OR NO BACKGROUND SO
IT'S IMPORTANT BECAUSE IT'S
IMPORTANT FOR US TO CONSIDER THE
LONG-TERM PART OF THIS IS THAT A
LOT OF US, A LOT OF PEOPLE HAVE
A GOOD UNDERSTANDING OF THIS
BECAUSE THEY HAVE BEEN DOING IT
FOR A WHILE BUT THERE'S A LOT OF
PEOPLE COMING IN WHO DO NOT AND
I'M MORE CONCERNED ABOUT THEM
COMING IN BECAUSE WE GIVE THEM
OUR RESPONSIBILITY AND THEY DO
NOT.
THEY CLAIRELY HAVE THEIR OWN
CHALLENGE, THEIR OWN SPECIFICS
IN TERMS OF WHAT THEY ALLOW AND
WHAT THEY WON'T ALLOW IN TERMS
OF DATA SHARING AND THAT SORT OF
THING.
WE TRAIN TO RESPOND TO RISK
AVERSE TYPES OF PERSON AS WELL.
IT ALL INVOLVES AROUND TRAINING
IN TERMS OF METHOD AND IN TERMS
OF STRATEGY AND THAT IS REALLY
IMPORTANT BECAUSE IN THE LONG
RUN IT IS WHAT GOES TO TODAY TO
ANSWER TO Y'ALL.
I HOPE THAT WASN'T TOO
COMPLICATED OR TOO -- TO
CONGREGATED TYPE OF QUESTIONS
BUT I THOUGHT ABOUT IT LISTENING
TO EVERYTHING THAT IS GOING ON
BUT THANK YOU FOR THIS.
>>SO A LOT OF GOOD POINTS THERE
AND QUESTIONS.
IN TERMS OF TRAINING, SO,
THERE'S TRAINING ON WHAT THE NIH
POLICY REQUIRES AND EXPECTS AND
WE HAVE A LOT OF RESOURCES ON
THAT IN PARTICULAR.
I WOULD ENCOURAGE YOU OR ANY NOT
TRAINEES OR POSTDOCS WHO ARE
INTERESTED AND THEY CAN GO BACK
AND LOOK AT THE TWO-PART WEBINAR
AND IN THE SUM YOUR WORSHIP OF
2022 AND THEY WERE EACH 90
MINUTES AND COVERING ALL THE
AVAILABLE RESOURCES WE HAD AND
COMMON QUESTIONS ABOUT THE
POLICY IN TERMS OF GETTING
FAMILIAR WITH WHAT IS NEEDED AND
HOW THAT MIGHT CHANGE THEIR
PRACTICES, AND ONE AREA TO POINT
FOLKS TO.
BEYOND THAT I REMEMBER ALSO
GETTING INTO THE QUESTIONS AND
TRAINING AND RESEARCH BASED ON
WHAT YOUR INSTITUTION MIGHT
REQUIRE AND YOUR INDEPENDENT
AREA OF SCIENCE AND IT'S GOING
TO VARY SO ONE THING TO MOVE
SCIENCE FORWARD AND WE HAVE
COLLEAGUES AND NIH OFFICE OF
DATA SHARING STRATEGIES OR ODSS
AND I'M NOT PUTTING ANYTHING
SPECIFIC HERE BUT JUST MENTIONED
THEY HAVE AN INTEREST IN LOOKING
AT HOW DATA CAN BE REUSED AND IN
PARTICULAR THE HIGHLIGHTED SOME
EXAMPLES OF HOW RESEARCHERS HAVE
DONE SOME ARE DATASETS AND
DEVELOPED SOME NEW KNOWLEDGE
FROM THAT SO WE MAY BE SEEING
SOME PRACTICAL EXAMPLES OF THAT
MIGHT HELP.
ANY OTHER THOUGHTS ON THAT ONE?
>>ANY RESOURCES THAT WE CAN
ADD.
I DO THINK THAT THERE'S FORMS
AND WE KNOW THAT PROJECT PILOT
BUT THAT'S ONE MENU WHERE
ADMINISTRATORS CAN COME TOGETHER
AND HAVE CONVERSATIONS JUST
ABOUT BEST PRACTICES AND OTHER
INSTITUTIONS SO I THINK THAT
HOPEFULLY THEY'LL BE INCREASING
FORMS FOR GENERAL COUNCIL
OFFICES AND OTHER KINDS OF NOT
RULES IN THE ENTERPRISE TO HAVE
CONVERSATIONS ABOUT DATA
SHARING.
>>I'M SORRY, DID YOU SAY FORUMS
OR FORMS?
I'M SORRY.
NOT.
>>I'M THINKING ABOUT FORUMS AND
OPPORTUNITIES FOR THOSE ROLES TO
COME TOGETHER.
>>LAURA --
>>HI, THANK YOU VERY MUCH.
I MISSED THE FIRST PART OF THE
PRESENTATION SO THIS MAY BE
REPETITIVE SO JUST LET ME KNOW.
I'M CURIOUS ABOUT THIS AS
SOMEONE WHO HAS HAD PEOPLE IN
THEIR GROUP WRESTLE FOR DB GAPS
SOMETIMES FOR YEARS.
TO GET DATA IN.
IF THERE ARE BENCHMARKS, THAT
ARE GOING TO BE PUT IN PLACE FOR
THE GOVERNMENTAL DATASETS, THAT
WOULD SAY YOU KNOW, THE
EXPECTATION IS THAT PEOPLE WILL
BE GOTTEN BACK TO IN X AMOUNT OF
DAYS AND THAT THINGS WILL BE
ESCALATED TO SOLVE PROBLEMS SO
THAT ON AVERAGE, WHEN SOMEONE
STARTS TO SUBMIT THEIR DATA,
DATA WILL BE IN WITHIN A MONTH,
WITHIN TWO MONTHS AND WHAT
METRICS AND I GUESS ALSO WHAT
RESOURCES EACH DATABASE IS
PLANNING TO PUT IN PLACE SO THAT
THIS REALLY WORKS SO THAT DATA
IS IN A TIMELY WAY DEPOSITED.
>>I REALLY APPRECIATE THAT
QUESTION.
IT'S NOT THE FIRST TIME THAT
WE'VE HEARD THAT DB GAP CAN BE
CHALLENGING TO THE DATA IN AND
TO GET DATA OUT.
I WORK CLOSELY WITH OUR
COLLEAGUES -- I WILL SAY OVER
THE LAST COUPLE OF YEARS, NC BYE
HAS DEVOTED A LOT OF THINKING
AND RESOURCES TO WORKFLOWS AND
SUPPORTING AND ENHANCING DATA
STAFF TO MAKE THAT PROCESSES
YEAR FOR DATA SUBMITTERS AND ON
THE OTHER SIDE DATA ACCESSERS.
AND THERE ARE SOME METRICS WE
HAVE USABILITY OF REQUESTS AND
THE ACCESS SIDE.
THAT GO INTO DB GAP TO BE
TRANSPARENT ABOUT THE VOLUME OF
OF REQUESTS THAT WE RECEIVED AND
THE VOLUME HAS GONE UP
SIGNIFICANTLY OVER THE PAST FIVE
TO SEVEN YEARS.
JURY POINT IS TAKEN ABOUT BEING
AWARE OF REPOSITORIES NOT
DEMONSTRATE ABOUT THE PROCESSES
AND THE TIME LINES REQUIRED
BETWEEN THE TIME THAT AN
INVESTIGATOR IS SUBMITTED THAT
DATA CAN BE MADE ACCESSIBLE SO
THOSE ARE REALLY IMPORTANT
POINTS.
>>BRIAN.
>>YEAH.
JUST A SHORT QUESTION.
AND A COMMENT.
IN THE STRUCTURAL BIOLOGY AND
CHEMICAL BIOLOGY FIELDS WE'VE
BEEN SHARING OUR DATA FOR A LONG
TIME.
THE RAW DATA IS THE MAPS ARE
UPLOADED INTO THE PROTEIN
DATABASE.
RAW IMAGES CAN BE UPLOADED INTO
THE EMPIRE DATABASE AS WELL.
AND THE QUESTION IS, THOUGH,
WHEN WE PUBLISH THE PAPERS NOW,
SORT OF IN THE BIG JOURNALS,
THEY REQUIRE THE RAW DATA AS
PART OF THE ACCEPTANCE PROCESS.
SO THE RAW DATA IS POST WITH THE
PAPER BASICALLY.
SO THE QUESTION IS THIS
REQUIREMENT TO HAVE THE RAW DATA
AVAILABLE OR DO WE HAVE TO
REPOST THE RAW DATA TO ANOTHER
(INAUDIBLE)?
THAT'S THE QUESTION AND THEN I
HAVE A COMMENT.
SO I SHARE THE CONCERN ABOUT THE
GEO LOCATION DATA BEING SHARED
WITH ANYONE.
PARTICULARLY IN THE GOVERNMENT,
ACTUALLY.
I'M STRONGLY AGAINST THIS.
I THINK IT'S A REALLY BAD IDEA.
I DON'T DO HUMAN CLINICAL
RESEARCH.
IT'S ENOUGH THAT APPLE KNOWS
WHERE I GO, I DON'T REALLY WANT
THE GOVERNMENT, IF I'M IN A
CLINICAL TRIAL, FOR WHATEVER, I
DO NOT WANT THE GOVERNMENT TO
HAVE ACCESS TO MY GEO LOCATION.
I THINK IT'S A REALLY BAD IDEA.
SO, THAT'S ALL I HAVE TO SAY.
>>SO ON THE QUESTION OF WHEN
YOU ARE SHARING DATA AS PART OF
THE PUN LA INDICATION PROCESS, I
PUBLICATION IS IT'S HOW IT'S
SHARED.
SAY YOU ARE DEPOSIT IN A RE POS
TORI ALONGSIDE THE METADATA THAT
YOU NEED TO REUSE THAT DATA, AND
THAT SOUNDS LIKE IT WOULD
PROBABLY BE FINDABLE ACCESSIBLE
AND ENTERSER OPERABLE AND
REUSABLE.
>>IF YOU GO TO THE PUBMed
RECORD, AND YOU CLICK ON THE
LINK, TYPICALLY THERE'S A LINK
TO THE DATA RIGHT THERE.
>>YEAH.
>>BUT FUR SAY DEPOSITING IT AND
THERE'S ONE ANSWER FOR
EVERYTHING BUT IF IT'S SHARED AS
WITH SUPPLEMENTAL PUBLICATION
FILE THAT MAY OR MAIN BE EASY TO
USE BUT THE POLICY DOESN'T SHARE
MUCH ON THIS PARTICULAR IN THIS
PARTICULAR WAY SO IF YOU ARE
PLANNING ON DEPOSITING IN IT,
KIND OF SUITABLE LOCATION, THEN
IT MAKES SENSE TO MENTION THAT
IN YOUR PLAN.
WITHOUT KNOWING THE SPECIFICS
I'M NOT THINKING ON YOUR ISSUES
THERE.
>>SCIENCE NATURE AND INAWE
REQUIRE YOU TO UP LOAD THE RAW
DATA.
(INAUDIBLE).
IT WOULD SEEM JUST NAIVELY IT
WOULD SEEM TO ME THAT WOULD
FULFILL THE REQUIREMENT BECAUSE
YOU DON'T HAVE TO SUBSCRIBE TO
THE JOURNAL OF ACCESS THE DATA.
IT'S THERE.
EVEN IF YOU ARE NOT SUBSCRIBE TO
THE JOURNAL.
YOU CAN GET IT AND YOU CAN GET
THE PAPER FROM IT.
SO, WOULDN'T THAT BE ACCEPTABLE?
ARE WE GOING TO HAVE TO -- IS
THERE A POLICY ON THIS?
>>WE DON'T HAVE A SPECIFIC FAQ
ON THAT BUT I THINK THE POLICY
ALLOWS FLEXIBILITY IN WHAT'S PRO
PRO AT FOR A GIVEN RESEARCH
PROJECT AND A GIVEN DMS PLAN SO
IT'S SOMETHING THAT CAN BE
INCLUDED IN THE PLAN AND
DISCUSSED AFTER THE (INAUDIBLE)
SPECIFIC PROJECT.
>>MARGARITE A AND THEN JOEL.
AND IT DEPENDS.
>>THIS IS SUPER HARD.
AND THIS IS NOT THE FIRST MAJOR
CHANGE THAT HAS HAPPENED IN NIH.
I REMEMBER THINKING I COULD
NEVER DO MY PROPOSALS AND NOW
I'M NEVER GOING BACK.
SO I DON'T ENVY YOU IN THIS JOB
AND I APPRECIATE ALL THE
LEARNING APPROACHES YOU ALL ARE
TAKING.
I HAVE TWO COMMENTS AND NOT
QUESTIONS.
ONE IS, GIVEN WHAT I'M HEARING
FROM COLLEAGUES, FOLKS ARE GOING
TO WANT TO KNOW HOW CAN THEY
APPEAL TO THE DECISION AROUND
THEIR MAKING -- IF THEY'RE
MAKING A CASE FOR LIMITING
SHARING THEIR DATA AND LET'S SAY
THE P.O. DECIDE IT'S NOT
APPROPRIATE, WHAT CAN THEY DO
THEN?
I SUSPECT AND KNOW THAT THEY'RE
GOING TO BE FOLKS WHO WANT TO GO
TO ANOTHER LEVEL TO TRY TO
ADDRESS THAT AND THEN IF THIS IS
ALL, IF THE DECISIONS AROUND
THESE EXCEPTIONS OR LIMITATIONS
OR FOR LIMITING THE DATA, ARE
BEING HELD AT THE P.O. LEVEL I
WOULD ENCOURAGE THE, WITH ANY
INSTITUTE THAT THE P.O. ARE IN
CONVERSATIONS WITH EACH OTHER
BECAUSE THERE'S AMONG MORE
FRUSTRATING THAN GETTING
DIFFERENT ANSWERS FROM DIFFERENT
PEOPLE AND SO JUSTEN SOARING
THAT THEY'RE ALL SHARING
INFORMATION AND LEVEL SETTING TO
MAKE SURE THEY'RE CONSISTENT IN
HOW THEY'RE MAKING THE DECISIONS
COULD BE REALLY HELPFUL.
>>AND JOEL.
>>JUST THREE QUICK THINGS.
I WANT TO ECHO THANKS FOR BOTH
THE OPEN MINDEDNESS AND THE
PROCESS OF LEARNING AS WELL AS
THE TREMENDOUSLY RICH SET OF
RESOURCES ON-LINE TO HELP WITH
THIS.
IT'S VERY, VERY HELPFUL.
I WOULD UNDERSCORE THE POINT
ABOUT LINKING THIS TO THE
EFFICIENCY OF THE GOVERNMENT
DATASETS, NOT JUST IN THE GAP
BUT ALL OF THEM.
I MEAN, THAT ONE OF THE CHARGES
GETTING DATA UP LOAD
SECOND-DEGUPLOADED AND USINGDATF
PUBLICATION IS YOU CAN'T.
YOU CAN SUBMIT IT BUT IT WON'T
BE UPLOADED UNTIL ALL KINDS OF
OTHER STEPS ARE TAKEN THAT YOU
CAN'T CONTROL AND THERE'S VERY
SLOW SO I WANT TO ECHO THE POINT
AND JUST ENCOURAGING LINKING
THIS TO THE AVAILABILITY AND THE
EFFICIENCY OF THE RESPONSE
DATASETS AND THEN ON THE POINT,
IN GIVING ADVICE ON WHAT TO DO
WITH SOME OF THE RULES THAT SEEM
LIKE YOU CAN'T OBEY THEM WITHOUT
VIOLATING SOME OTHER RULE, IT'S
A CHALLENGE BECAUSE THERE'S A
LOT OF THOSE AND SO FREQUENTLY
THERE ARE THINGS THAT HAVE TO BE
ADJUDICATED OR ESCALATED BUT
THEN IT'S UNCLEAR WHO THE
AUTHORITY IS BECAUSE THE P.O. IS
ONE AUTHORITY AND SO IS THE
SUPERVISOR WHOEVER WHAT DATABASE
YOU ARE WORKING WITH ON THE
RULES OF THE GOVERNMENT PLAN.
SO THE COORDINATION THERE
DECIDING WHO REALLY SHOULD
ADJUDICATE THESE QUESTIONS IS
VERY IMPORTANT IN TERMS OF THE
POLICY AS YOU IMPLEMENT IT AND
AS YOU SAY, I KNOW THIS IS GOING
TO BE LEARNING BY EXPERIENCE FOR
ALL OF US SO I WANT TO
UNDERSCORE THOSE POINTS.
THANK YOU, VERY MUCH.
>>GREAT.
LOOKS LIKE THAT'S ALL QUESTIONS
WE HAVE SO JULIA, THANK YOU SO
MUCH FOR THE VERY INFORMATIVE
PRESENTATION AND ALL THE WORK
THAT YOU'VE DID NOT DOING.
THANK YOU ALL FOR YOUR COMMENTS.
WE HAVE A BREAK NOW UNTIL 2:30.
SO, ENJOY.
CATCH UP ON E-MAILS, THANK YOU.
BYE-BYE.
>>THANK YOU FOR YOUR
FORBEARANCE THIS AFTERNOON.
I'M SORRY I COULDN'T BE WITH YOU
IN-PERSON TO START THE MEETING
AND I HAD TO MISS MUCH OF THE
FIRST HALF OF THE MEETING FOR
ANOTHER EVENT THAT WAS TAKING
PLACE ON AMOUNT PUSS BUT I'M
REALLY PLEASED TO JOIN YOU
TODAY.
>> Joshua Gordon: GIVE YOU THE
UPDATE FROM MY PERSPECTIVE AND
STUFF PUTTING IT TOGETHER.
I'M EXCITED TO WHAT WE HAVE TO
TALK ABOUT THAT INCLUDES
RESOURCES THAT WE HOPE WILL HELP
OUR INVESTIGATORS AND HEARING
THE PUBLIC COMMENT RETURN NOW
THAT WE ARE IN THIS HYBRID MODE.
SO THANK YOU AGAIN.
NOT JOINING THE AUDIO.
FOR THE OPPORTUNITY TO TELL YOU
WHAT IS HAPPENING AROUND THE NIH
AND NIMH.
LET'S SEE.
WHO IS RUNNING THIS SLIDES.
SHOULD I DO IT FROM HERE?
>>THEY'RE RUNNING IT.
I'LL WAIT FOR THEM TO APPEAR.
HERE WE GO.
SO IF I CAN HAVE THE NEXT SLIDE.
PLEASE.
SO, AS USUAL FROM MY TALK IT'S A
PACKED AGENDA, I'LL TALK TO YOU
ABOUT SOME CONGRESSIONAL
INTERACTIONS APPROPRIATIONS AND
BUDGET UPDATES.
AS I MENTIONED LAST TIME,
CONTINUED GOODS NEWS IN TERMS OF
INTEREST IN THE WHITE HOUSE AND
ALSO UPDATES AND HHS AND AROUND
THE NIH SOME NEWS TO KNOW FROM
OUR INSTITUTE AND I'LL CLOSE
WITH A COUPLE OF HIGHLIGHTS
BEFORE REMINDING YOU ABOUT THE
75th ANNIVERSARY TO END.
IS WE'VE HAD A BUSY SPRING AND
OF COURSE THAT IS TYPICAL FOR
THE LEAD INTO TO THE PREPARATION
SEASON AND IT'S A TYPICAL IN
TERMS OF AS I'VE BEEN MENTIONING
NOW FOR A WHILE, CONTINUED
INCREASES AND INTEREST AMONGST
CONGRESSIONAL MEMBERS AND
HEARING FROM NIMH BOTH IN ELSE
IT O TRYING TO WHAT WE NEED TO
UNDERSTAND OUR RESEARCH AND
UNDERSTANDING WHAT INFORMATION
WE CAN PROVIDE BETWEEN MYSELF
AND OTHER STAFF WE PARTICIPATED
IN SEVEN DIFFERENT CONGRESSIONAL
BRIEFINGS WITH MEMBERS AND
STAFF.
THE TOPICS INCLUDE SUICIDE
PREVENTION, HEALTH DISPARITIES,
SERIOUS MENTAL ILLNESS, SOCIAL
MEDIA AND MORE AND ONE OF THOSE
THEY'RE TWO SEPARATE CAUCUSES IN
THE HOUSE AND THEY CAME TOGETHER
WHERE IT WAS MYSELF AND SOMEONE
FROM THE OFFICE OF NATIONAL DRUG
CONTROL AND POLICY AND REALLY
TALKING ABOUT ALL THINGS, MENTAL
HEALTH AND SUBSTANCE ABUSE AND
IT WAS REALLY A VERY RICH EFFORT
AND IT WENT ON.
WE ARE IN APPROPRIATIONS SEASON.
AS THE HOUSE AND SENATE BEGIN TO
CONTEMPLATE THE OF 2024 BUDGET.
THERE'S BEEN HEARING BETWEEN
MARCH AND MAY WHICH INCLUDED THE
OF THE SECRETARY OF HHS OF
COURSE AND ALSO IT WAS
PRIVILEGED HE ANSWERED A
UNPRESIDENT NUMBER OF QUESTIONS
ON MENTAL HEALTH.
INTEREST IN THE SAME TOPICS THAT
I JUST MENTIONED BEFORE AND ALSO
INTEREST IN UNDERSTANDING MORE
ABOUT OUR PRECISION PSYCHIATRY
INITIATIVES WHICH WERE MENTIONED
IN THE PRESIDENT'S JUDGE ET AS
WELL AS OUR INITIATIVES OF YOUTH
MENTAL HEALTH MORE BROADLY.
IT WAS A POSITIVE GIVE-AND-TAKE
WITH THE SENATORS REALLY VOICING
THEIR SUPPORT FOR NIH.
OF COURSE WE DON'T KNOW WHERE
THAT WILL PUT THE BUDGET FOR
2024 BUT I WANT TO GO OVER SOME
UPDATES THROUGH THE 2023 BUDGET.
NEXT SLIDE.
WHICH NOW WE'RE WELL INTO OF
COURSE THIS REPRESENTS THE LAST
FULL COUNCIL FOR GRANTS AND IT
WILL BE FUNDED FOR 2023 AND WE
DO GRANTS IN AUGUST AND
SEPTEMBER THAT COME IN ADVANCE
OF THE OCTOBER COUNCIL.
ON DECEMBER 29th, LAST TIME,
PRESIDENT JOE BIDEN SIGNED INTO
LAW THE COMBINED OR CONSOLIDATED
APPROPRIATIONS ACT WHICH GAVE
$2.3 BILLION TO THE NATIONAL
INSTITUTE OF MENTAL HEALTH
INCLUDING A LARGE FROM THE CURES
ACT TO HELP FUND THE AMBITIOUS
NOT AND BRAIN INITIATIVE.
AND NOTE, TWO LINE ITEMS IN
THERE, $25 MILLION TO OUR
INSTITUTE TO EXPAND OUR RESEARCH
ON COVID-19 AND MENTAL HEALTH.
YOU WILL SEE SOME OF THOSE
GRANTS IN THE PORTFOLIO THAT WE
REVIEWED TOMORROW AND CLOSED
SESSION.
IT ALSO INCLUDES AN INCREASE OF
$5 MILLION FOR APPROACHES AND
SERVICE DELIVERY AND WE'ROUSING
THIS AND OTHER APPROACHES AND
SYSTEMS DELIVERY.
NEXT SLIDE.
THIS IS THE COMBINED NUMBER OF
APPLICATIONS AND NUMBER OF
GRANTS AWARDED THAT WE HAVE THE
LAST SIX YEARS AND INCLUSIVE
LAST YEAR 2022 AND AN ESTIMATED
AMOUNT FOR 2023 AND OF COURSE
WE'RE NOT FINISHED FOR 2023 BUT
IT'S ESTIMATED.
YOU WILL NOTE WE SEE SUSTAINED
INTEREST AND WITH THE GRANT
NUMBERS AND SLIGHTLY LAST YEAR
AND WE HAVE APPROXIMATELY
SIMILAR MEMBERS OF GRANTS AWARD
AND THE ABSOLUTE NUMBER IS A
SLIGHT DECREASE AND DUE TO THE
INCREASE IN THE SIZE OF AWARDS.
PARTICULARLY TRUE OF THE BRAIN
INITIATIVE AWARDS THAT WE GIVE
OUT AS WELL AND SO THAT IS THE
REASONS WHY AND AND WE SEE A
SLIGHT DECREASE IN THE NUMBER OF
AWARDS WE ANTICIPATE GIVING IN
2023.
NEXT SLIDE.
THIS IS THE CHART OF THE BUDGET
THAT I'VE BEEN SHOWING YOU FOR A
WHILE YOU CAN SEE THE BRAIN
INITIATIVE FROM THE CURES ACT.
THIS IS NOT -- DID NOT RESULT IN
THE TOTAL DOLLARS TO NMIH AND
SPENDING O THE BRAIN INITIATIVE
AND THE BULK WAS MADE IN A
DECREASE HITTEN THERE WHICH SAY
SLIGHT BLUE, IT'S PART OF OUR
BASE BUDGET THAT WE'VE BEEN
SPENDING ON THE BRAIN INITIATIVE
SINCE ITS INCEPTION IN 2016.
SO, ACT APPROPRIATIONS AS
OPPOSED TO GENERAL
APPROPRIATIONS BY CONGRESS.
YOU WILL SEE AGAIN, FOR I THINK
IT'S SEVEN STRAIGHT YEARS, THE
BUYING PAUSH OF NIMH SPONSORED
RESEARCH HAS INCREASED SO WE ARE
KEEPING ABOVE INFLATION EVEN
WITH THE SIGNIFICANT INCREASE IN
INFLATION AND THE PAST YEAR AND
THE MORE MODEST INCREASE IN OUR
BUDGET.
I HAVE IDEA AND SUPPORT FROM
CONGRESS AND BOTH HOUSES ARE
INTERESTED IN SUPPORT FROM
ROBUST AND BIGGER ISSUES AT PLAY
IN THE CONGRESSIONAL DISCUSSIONS
OVER THE BUDGET LINE TO SEE HOW
IT PLAYS OUT IN THE COMING
MONTHS.
NEXT SLIDE.
AS A FORESHADOWING OF THAT
BUDGET DISCUSSION ON MARCH 9
THE, THE PRESIDENT RELEASED THE
BUDGET REQUEST FOR FISCAL YEAR
2024, IT ESSENTIALLY PROPOSES A
VERY MODEST INCREASE FROM NIH OF
$920 MILLION OVER 1/5 OF THAT
BUDGET INCREASE THE PRESIDENT
PROPOSED TO COME TO THE NIMH
THAT WOULD BE A NEAR 10%
INCREASE IN OUR NON BRAIN BUDGET
AND SPECIFICALLY AROUND
PRIORITIES THAT WE IDENTIFIED
WITH TREE, THESE ARE INITIATIVES
THAT YOU ALL APPROVED ALREADY IN
THE PAST AND OTHER INITIATIVES
THAT WE PLAN TO BRING FORWARD.
TO DEVELOP NOVEL TREATMENTS AND
SPECIFIC NOT SET ASIDE
$20 MILLION FOR MENTAL HEALTH
IMPACT OF SOCIAL MEDIA AND
$50 MILLION TO SUPPORT THE
CHRISTIAN PSYCHIATRY INITIATIVE
THAT WE'VE BEGUN AND HOPE TO
EXPAND IF WE RECEIVE THIS
INCREASE IN APPROPRIATIONS.
THIS IS THE PRESIDENT'S REQUEST.
WE ALSO HAD THE CHANCE TO MEET
WITH STAFF OF THE HOUSE AND
SENATE TO EXPLAIN THIS REQUEST
AND TO PROVIDE WHAT IS CALLED A
PROFESSIONAL JUDGMENT BUDGET
WHICH GOES BEYOND THIS REQUEST
AND TO SAY WHAT WE NEED IF WE
WANTED TO MAXIMIZE OUR ADDRESSES
OF CHALLENGING AND SERIOUS
MENTAL ILLNESS AND SO, WE'LL SEE
WHAT CONGRESS DOES WITH BOTH OF
INFORMATION THAT WE GAVE THEM
THROUGH THAT PROFESSIONAL
JUDGMENT BUDGET AS WELL AS AS
THE PRESIDENT'S OWN BUDGET
REQUEST.
NEXT SLIDE.
SO NOT MUCH MORE TO DO WITH
20924 BUDGET EX SEPARATE AND
WE'LL GO OVER TO OTHER NEWS FROM
THE WHITE HOUSE AND HHS AND NIH.
FIRST SOME ANNOUNCEMENTS AND
INITIATIVES.
NEXT SLIDE.
THE WHITE HOUSE PUT OUT A REPORT
ACROSS THE GOVERNMENT AND I WANT
TO MENTION THE WORK OF THE
SHELLY AND BOB SIGN SEN WHO
WORKED HARD WITH MEMBERS OF OSDP
AND REALLY OTHERS ACROSS
GOVERNMENT AND BACKED UP WHICH
MANY, MANY DIFFERENT PROGRAM
STAFF TONE SURE THAT THESE
PRIORITIES MET OR AGREED WITH
MOST OF ANYMORE'S PRIORITIES AS
WELL AND THE AREAS OF 'EM IF SIS
AND GOVERNMENT WIDE PERSPECTIVE
INCLUDE MENTAL HEALTH INEQUITIES
AND UNDERSTANDING DIGITAL MENTAL
HEALTH INTERVENTIONS AND
SUPPORTING MENTAL HEALTH
WORKFORCE AND THE REPORT
HIGHLIGHTS SEVERAL RESEARCH
INITIATIVES THAT ARE ALREADY
UNDERWAY AS WELL AS PROPOSING TO
ENHANCE SOME OF THE ONCE THAT WE
HOPE TO DO IN THE FUTURE.
NEXT SLIDE.
THE WHITE HOUSE HAS BEEN
THINKING ABOUT MENTAL HEALTH
IT'S ALSO BEEN THINKING ABOUT
RESEARCH IN GENERAL.
AS YOU KNOW IN 2022 THE WHITE
HOUSE OFFICE OF SCIENCE AND
TECHNOLOGY POLICY RELEASED A
MEMORANDUM ON ENSURING FREE AND
IMMEDIATE EQUITABLE ACCESS TO
FEDERAL FUNDED RESEARCH AND THIS
MEMORANDUM AND A EXECUTIVE ORDER
FROM THE PRESIDENT ESTABLISHES
THAT NIMH SUPPORTED RESEARCH
WILL NEED TO BE IMPROVE PUBLIC
ACCESS TO PUBLICATIONS INCLUDING
ELIMINATING THE 12-MONTH WAITING
PERIOD FOR RESEARCH TO BE
PUBLICLY ACCESSED.
WE HAVE A FEW YEARS BEFORE THIS
TAKES EFFECT BUT WE WANT TO MAKE
SURE THAT OUR RESEARCHERS AND
THE JOURNALS AND THAT EVERYONE
ELSE IN THE KNOWS WHAT TO HE
EXPECT AND WE HAVE LISTENING
SESSIONS AND SEEK PUBLIC ACCESS
AND PUBLIC GUIDANCE ON OUR PLAN
TO ENHANCE PUBLIC ACCESS
INCLUDING A LISTENING SESSION
THAT TOOK PLACE IN APRIL.
THE NIH HAS ALSO DEVELOPED A
STRATEGIC PLAN FOR DIVERSITY
EQUITY INCLUSION AND
ACCESSIBILITY COVERING THE
FISCAL YEAR THROUGH 2027.
THIS STRATEGIC PLAN ARTICULATES
NIH'S COMMITMENT TO EMBRACING,
STRENGTHENING AND INTEGRATING
DEIA INTRAMURALLY AND
EXTRAMURALLY AND ENCOURAGE YOU
TO TAKE A LOOK AT THIS STRATEGIC
PLAN.
MANY OF THE PRIORITIES
IDENTIFIED IN HERE ARE THINGS
THAT NIMH HAS ALREADY BEEN
WORKING ON AND HAS ALREADY
INCORPORATED TO ITS STRATEGIC
PLAN ALTHOUGH AS I SAY IN A
MOMENT, WE JUST FINISHED AN
UPDATE ANNOUNCED IN A NEW PRIZE
COMPETITION FOR INSTITUTIONAL IN
DEIA ACTIVITIES AND IT WAS
ANNOUNCED APRIL 4th AND
DEADLINE IS THIS SEPTEMBER AND
FOR THOSE WHO ARE INTERESTED IN
HELPING THEIR INSTITUTION APPLY
FOR THESE PRIZES, THE -- THERE'S
AN INFORMATIONAL WEBINAR
TOMORROW AT 1:00.
YOU CAN LOOK ON THE NIH WEBSITE
TO FIND OUT MORE ABOUT IT.
THE ALL OF US RESEARCH PROGRAM
PARTNERING WITH NIMH TO HELP US
IN OUR EFFORTS TO UNDERSTAND HOW
BEHAVIORAL TESTS MIGHT BE ABLE
TO INFORM DECISIONS ABOUT --
DIAGNOSTICS AND DECISIONS ABOUT
CLINICAL PREDICTION.
THE ALL OF US HAS BEEN REALLY
BUSY RAMPING UP THEIR ENROLLMENT
AND IMPORTANTLY RELEASING DATA
PACKAGES AND DATA PLATFORMS AS
WELL AS DATA ANALYTICS PLATFORMS
AND ON MARCH 29th THROUGH THE
31st THEY HOST AID VIRTUAL
RESEARCHERS CONVENTION TO
PROVIDE AN OPPORTUNITY FOR
RESEARCHERS WHO USE ALL OF US
DATA AND TOOLS TO SHOWCASE THEIR
WORK AND TO LEARN BEST
PRACTICES.
AND FOR THOSE DATA SCIENTISTS
OUT THERE AND IN THE UNIVERSE I
WILL REMIND THEM OF DATA I'VE
SHOWN IN THE PAST AND OF THE
TALK WE HEARD FROM ALL OF US
RECENTLY WHERE IT'S VERY CLEAR
THAT THE ENROLLMENT IS INCLUSIVE
OF INDIVIDUALS WITH A VARIETY OF
MENTAL ILLNESSES SO THERE'S MUCH
TO BE LEARNED FROM THE DATA THAT
AWFUL US HAS ALREADY RELEASED
AND THE DATA THAT WILL CONTINUE
TO BE RELEASED IN THE FUTURE AND
FOR THOSE OF YOU WHO ARE
PERSONALLY INTERESTED IN
PARTICIPATING IN ENROLLMENT
CONTINUES IT'S EASY AND YOU CAN
GO ON-LINE AND YOU CAN GO TO ONE
OF THEIR MANY PHYSICAL EXAM AND
SAMPLE SELECTION SITES ACROSS
THE UNITED STATES AND DONATE A
LITTLE BIT OF BLOOD AND GET
YOURSELF MEASURED AND YOU ARE ON
THE WAY.
IT'S A GREAT WAY TO CONTRIBUTE
TO SCIENTIFIC ADVANCEMENT AND
YOU CAN DONATE YOUR CLINICAL
RECORDS WITH PRESS OF A FEW
CLICKS OF YOUR MOUSE AND THE
RESULTS OF THIS RESEARCH ARE
SHARED WITH YOU AS A PARTICIPANT
IN THE PROGRAM.
ANOTHER INITIATIVE IS THE BRAIN
INITIATIVE.
ALMOST HALF OF THE BRAIN
INITIATIVE BRANCH COME THROUGH
THE NIH.
THE NIMH AND IN PARTNERSHIP WITH
THE NATIONAL INSTITUTE OF
NEUROLOGICAL DISEASE AND STROKE,
WE LEAD THE BRAIN INITIATIVE
WHICH NOW OF COURSE HAS A
PERMANENT DIRECTOR IN JOHN NAI
AND DEPUTY DIRECTOR ANDREA
BECKEL-MITCHNER.
THEY WILL HOST THE NINTH
NATIONAL BRAIN INITIATIVE
MEETING.
JUST NEXT MONTH.
IT WILL HAVE IN-PERSON AND
VIRTUAL COMPONENTS AND IF YOU
ARE INTERESTED TO SIGN UP AND
ATTEND HERE IN THE D.C. AREA OR
IF YOU CAN'T MAKE IT.
NEXT SLIDE.
I WANTED TO GIVE YOU AN UPDATE
ON A PROGRAM THAT WE'RE
ESPECIALLY PROUD OF, THE
ACCELERATED MEDICINE PARTNERSHIP
PROGRAM FOR SCHIZOPHRENIA.
AS YOU WILL REMEMBER, THOSE OF
YOU ARE ON COUNCIL AND MANY OF
YOU IN THE AUDIENCE WHO HAVE
BEEN WITH US BEFORE.
THE AMPS SCHIZOPHRENIA PROGRAM
IS ONE THAT SEEKS TO UNDERSTAND
WHETHER WE CAN USE BIOMARKERS
AND FOR TREATMENT DEVELOPMENT
AND IT WILL HELP BOTH REDUCE
SYMPTOMS AND PERHAPS PREVENT
TRANSITION TO PSYCHOSIS IN YOUTH
AND YOUNG ADULTS AND TEENAGERS
AT RISK FOR A FIRST EPISODE OF
PSYCHOSIS AND THIS IS A TRUE
GLOBAL EFFORT AS YOU CAN SEE BIT
MANY DIFFERENT SITES DISTRIBUTED
ACROSS MULTIPLE CONTINENTS AND
IT SOLVES TWO SEPARATE NETWORKS
THAT HAVE AGREED, THEY HAVE
AGREED TO USE THE SAME
PROTOCOLS, SAME OUTCOME MEASURES
AND SHARE THEIR DATA TO MAXIMIZE
OUR ABILITY TO REACH NOT THIS
IMPORTANT GROUP AND A MILLER
EIGHT PSYCHOPATHOLOGY AND
PREVENT 123 WORSING OF THAT TYPE
OF PATHOLOGY.
THE PARTNERSHIP IS ONE THAT IS
RUN BY THE FOUNDATION FOR THE
NATIONAL INSTITUTE OF HEALTH.
IT'S A PUBLIC-PRIVATE
PARTNERSHIP INVOLVING
PHARMACEUTICAL COMPANIES, NIMH
AND ADVOCACY ORGANIZATIONS THE
AND OTHER NON PROFITS AND AND
WE'RE PROUD WE'VE BEGUN
ENROLLMENT INTO THESE COHORTS
AND THEY ARE RAMPING UP AS WE
SPEAK TO FULL STATUS AND WE HOPE
TO BE ABLE TO SHARE WITH YOU
INTERESTING RESULTS FROM THAT AS
IT BECOMES IN THE COMING YEARS.
NEXT SLIDE.
IN JUNE OF 2022 IS WHEN A YEAR
AGO NOW, RESEARCH STUDY
PARTICIPANTS IN ENROLLING AND IN
DECEMBER OF 2022, THE FNIH
RELEASED A REQUEST FOR
INFORMATION ON COMPOUNDS THAT
COULD BE USED IN THE PROOF OF
PRINCIPLE CLINICAL TRIALS THAT
COULD BE USED TO TRY TO ASSIST
INDIVIDUALS IN THESE GROUPS.
THEY RECEIVED A NUMBER OF
DIFFERENT POTENTIAL, A NUMBER OF
DIFFERENT SUGGESTIONS FOR
POTENTIAL COMPOUNDS TO EVALUATE
AND THAT WORK IS ON GOING AND WE
HOPE TO BE ABLE TO BEGIN
CLINICAL TRIALS IN THIS GROUP IN
THE NEXT MISS CAL YEAR IN
FEBRUARY OF 2023, SCHIZOPHRENIA
DEVELOPERS REPORTED ON THE
FINALIZATION OF HARMONIZED
CLINICAL OUTCOME ASSESSMENT USED
AT THE ALL THE SITES AND THIS
SPRING WE HOPE TO PUBLISH A
FUNDING ANNOUNCEMENT ON THOSE
CLINICAL TRIALS THAT WE'LL HOPE
TO GIVE IN THE NEXT FISCAL YEAR.
ANOTHER NIH WIDE INITIATIVE IS
POSTDOCTORAL FELLOWS AND HOW TO
SUPPORT BEST.
THERE'S INCREASING RECOGNITION
THAT LEVE LEVELS LEVELS OF SUPP,
FINANCIAL SUPPORT, RESOURCES OR
BENEFITS ARE INSUFFICIENT TO
SUPPORT EARLY CAREER SCIENTISTS
AND ENSURE THEY STAY ENGAGE IN
THEIR SCIENTIFIC CAREERS AND AS
A RESULT THE NIH DIRECTOR ASKED
THE ADVISORY HAD COMMITTEE ON
REIN-VISIONING NIH SUPPORTED
POSTDOCTORAL TRAINING AND THIS
GROUP HAS ISSUED A REQUEST FOR
INFORMATION WHICH IS NOW CLOSED
BUT WE'VE RECEIVED THOUSANDS OF
SUBMISSIONS AND IS CONDUCTING A
SERIES OF WORKING GROUP
LISTENING SESSIONS HEARING FROM
POSTDOCS AND OTHERS ABOUT THE
ISSUES THEY FACER AND FROM
CHILDCARE COMPENSATION ALL THE
WAY THROUGH TO CAREER PROSPECTS
AND QUALITY OF LIFE AND WE HOPE
TO HEAR A REPORT THAT WE CAN
THEN ADOPT NIH WIDE TO TRY TO
IMPROVE THE LOT OF OUR
POSTDOCTORAL WHO DO MUCH OF THE
WORK THAT YOU ALL APPROVE EACH
YEAR AND O TO BE FUNDED.
NEXT SLIDE.
ANOTHER ISSUE EFFECTING TRAINING
IS THE PLANNED REVISION OR
REVIEW OF THE IS CRITERIA FOR
NATIONAL RESEARCH SERVICE AWARD
FELLOWSHIPS AND NRSA FELLOWSHIPS
ARE PRE-DOCTORAL AND
POSTDOCTORAL AND THE HOPE IS
THAT IF WE CAN GET THE REVIEW
CRITERIA CORRECT.
THAT WE CAN HELP IN THE GOAL OF
DIVERSIFYING OUR WORKFORCE BASED
ON MERIT AND NOT OTHER VARIABLES
I NOTE THE PROPOSED REVIEW
CRITERIA MODIFICATIONS HERE
WHICH INCLUDE A FOCUS ON THE
APPLICATION POTENTIAL AND THE
STRENGTH AND SCIENCE AND IS A
BETTER DEFINED CRITERIA AND
APPLICANTS AND THAT GIVES LESS
ADVANTAGE APPLICANTS A FAIR
CHANCE AND ARE AND THE SHOP
THROUGH THIS REVIEW WE CAN
IMPROVE OUR ABILITY TO EVALUATE
FELLOW SHOP APPLICATIONS AND
MAKE THE PROCESS FAIR.
WE'RE SEEKING FEEDBACK NOW ON
THIS REVISION AND SO, I'LL CALL
YOUR ATTENTION TO THE REQUEST
FOR INFORMATION THAT CSR PUT OUT
ON THE PROPOSED CHANGES THAT
THOSE RESPONSES ARE DO AT THE
END OF JUNE AND AS WELL AS
DETAILS ON THE RECOMMENDATIONS
FOR IMPROVING NRSA FELLOWSHIP
REVIEW AVAILABLE ON THE WEBSITE.
I CO-CHAIR THE AWE TIM COMMITTEE
ON BEHALF OF THE SECRETARY FOR
HEATH AND HUMAN SERVICE AND WE
AT NIMH THROUGH THE RESEARCH
COORDINATION RUN THAT AND
PROVIDE REPORTS TO CONGRESS AND
THE PUBLIC ON THE STATE OF
AFFAIRS FOR AUTISM AS WELL AS A
STRATEGIC PLAN FOR AUTISM CARE
AND RESEARCH AND ON APRIL 4th,
AND INFORMING A RESEARCH AGENDA
HERE AT NIH, THE IACC HELD A
VIRTUAL MEETING AND WE DISCUSSED
UPDATES FROM THE U.S. CENTERS
FOR DISEASE CONTROL ON AUTISM
PREVALENCE AS WELL AS DISCUSS
RACIAL OF ECONOMIC AND AUTISM
SPECTRUM DISORDER AND HOLD ON TO
THAT THOUGHT BECAUSE THE SCIENCE
WILL HIGHLIGHT THOSE IN JUST A
FEW MOMENTS.
IN APRIL IN HONOR OF AUTISM
AWARENESS MONTH.
THEY HOSTED THE AUTISM SPECIAL
EVENT SHOWING ARTISTS WHO ARE ON
THE SPECTRUM AND THEIR WORKS IS
REALLY A WONDERFUL SHOWCASE AND
I URGE YOU TO TAKE A LOOK AT THE
MATERIAL FROM THAT EVENT AND TO
LOOK AT THE ARTIST WORK WHICH IS
AVAILABLE OVER THE INTERNET TO
LOOK AT AND IT'S REALLY
ASTOUNDING STUFF AND ABSOLUTELY
BEAUTIFUL AND SPEAKS TO THE
CREATIVITY OF MANY INDIVIDUALS
ON THE SPECTRUM AND THEIR
CAPABILITIES.
ONE OF THE THINGS WE'RE CHARGED
WITH AT NIMH AND NIH MORE
BREEDLY IS ENSURING THAT OUR
RESEARCH RESULTS IN PUBLIC HEATH
IMPACT.
AND AS MANY OF YOU KNOW, THERE
ARE MEMBERS OF OUR RESEARCH
FIELD WHO FREQUENTLY SAYS THAT
RESEARCH AND MENTAL HEALTH HAS
NOT ACHIEVED PUBLIC-HEALTH
IMPACT.
AND WE RECOGNIZE THAT THIS IS
FALSE AND THAT MUCH OF THE
INVESTMENTS MADE THROUGH THE NIM
AND OTHER PLACES HAVE PAID OFF
TREMENDOUSLY IN TERMS OF
BENEFITS FOR INDIVIDUALS WITH
MENTAL ILLNESS AND THEIR
FAMILIES AND COMMUNITIES.
IS IT WANTS YOU TO HELP MESSAGE
THE NOTION THAT RESEARCH NOT
INVESTMENTS IN THE BIOMEDICAL
SPACE DO PAYOFF IN TERMS OF
PUBLIC-HEALTH RESEARCH AND SO
THEY REVAMPED THEIR WEB PAGE
THAT DETAIL THE IMPACT OF THE
NIH RESEARCH AND I'M PROUD TO
SAY THAT THE EFFORTS TO HELP
WITH FIRST PSYCHOSIS OR FUTURE
PROM INNANTLY NOW ON THE WEBSITE
WITH THE HANDOUT THAT'S
AVAILABLE AND IS EXPLAINS HOW
RESEARCH ENCORE DINNATED
SPECIALTY CARE HAS TRANSFORMED
THE THIS RESEARCH MILESTONES AND
SPECIALTY CARE FOR EARL
SCHIZOPHRENIA I ENCOURAGE YOU TO
LOOK AT IT AND SHARE IT WITH
YOUR COLLEAGUES BECAUSE TOO
OFTEN IN OUR FIELD, WE EMPHASIZE
WHAT WE DON'T KNOW AND WHAT WE
HAVEN'T ACCOMPLISHED AND IT'S
GREAT BECAUSE WE SHOULD BE
LOOKING FOR WHAT WE CAN DO TO
HELP PEOPLE SUFFERING FROM
MENTAL ILLNESS AND WE SHOULD
LOOK AT WHAT WE HAVEN'T DONE AND
THE GAPS AND NEEDS AND IF WE
DON'T PAUSE TO RECOGNIZE WHAT
RESEARCH HAS ACCOMPLISHED, HOW
CAN WE ASK CONGRESS FOR DOLLARS
OF RESEARCH WHICH IN THE END
DON'T PAYOFF.
IF WE CAN SHOW THEM WHAT WE'VE
DONE WITH THE MONEY IN, WHAT THE
RESEARCH OF ALL OF YOU AND THE
RESEARCH OF THOUSANDS AND
THOUSANDS OF PEOPLE AROUND THE
GLOBE HAVE ACCOMPLISHED IN
MENTAL HEALTH DELIVERY WE HAVE A
BETTER CASE FOR ADDRESSING THE
GAPS AND NEEDS THAT WE ALL
HIGHLIGHT SO I WANTED TO CALL
THIS OUT TO YOU AND MAKE SURE
YOU RECOGNIZE THAT.
>>NEXT SLIDE.
IT WAS ANNOUNCED YESTERDAY THE
WHITE HOUSE INTENDS TO APPOINT
MONDAYA MONICABERTAGNOLLI THE SO
PERMANENTLY LEAD THE DIRECTOR OF
THE NIH AND IF SHE'S CONFIRMED
BY THE SENATE AND UNTIL THAT,
SHE WILL REMAIN AS A COLLEAGUE
OF MINE AND THE DIRECTOR OF THE
NATIONAL CANCER INSTITUTE AND
DR. TABAK WILL CONTINUE AS
ACTING DIRECTOR OF NIH SINCE THE
INTENTION TO NOMINATE WAS MADE.
ON MAY SIXTH, A LONGSTANDING
CONTRIBUTING TO MANY COMPELLING
POLICIES INCLUDING THOSE ON DATA
SHARING, CLINICAL TRIALS AND
OTHER TRIALS STEPPED DOWN FROM
HER THEN ROLE AS SENIOR ADVISER
IN THE OFFICE OF THE DIRECTOR
FOR A LONG TIME SHE SAID THE
OFFICE OF SCIENCE POLICY IN
BUILDING ONE AT NIH AND REALLY
INFLUENCED A LOT OF THE THINGS
THAT WE TALK A LOT ABOUT
INCLUDING THE DATA SHARING STUFF
AND AND MANY OTHER THINGS.
AND SHE IS MOVING ON TO NEW MASS
TIMES AND ADVENTURES BUT WE WISH
HER LUCK.
IS ON APRIL 24th, KARINA
WALTERS IS BEGAN SEARCHING AT
THE TRIBAL HEALTH RESEARCH
OFFICE AND REPLACING Dr. DAVID
WILSON WHO IS ASSIGNMENT TO THE
WHITE HOUSE COUNCIL ON NATIVE
AMERICAN AFFAIRS AND WE'RE HAPPY
TO HAVE Dr. WALTERS LEAD THIS
IMPORTANT OFFICE WHICH HAS MANY
COLLABORATIONS WITH THE NIMH AND
SHE'S A MEMBER OF THE CAUCUS
FOUNDATION OF OKLAHOMA AND SHE
COMES TO US FROM THE UNIVERSITY
OF WASHINGTON WHERE HER RESEARCH
IS 'E IMPECCABLE.
ANOTHER TRANSITION WE NOTE THAT
Dr. MARINE GOODNOW
TRANSITIONED FROM HER ROLE FOR
AIDS RESEARCH AND DIRECTOR OF
THE NIH OFFICE OF AIDS RESEARCH
TO A NEW ROLE AS SENIOR ADVICE
TORE DR. TABAK IN HIS ACTING
ROLE AS NIH DIRECTOR.
SHE WILL BE SUCCEEDED BY IS CAP'
GIANNIS OF SIDES RESEARCH AND
I'LL POINT OUT THAT OAR AND THE
ASSOCIATE DIRECTOR HAVE BEEN
TREMENDOUSLY SUPPORTIVE OF NIH
INITIATIVES AND RELATED TO THE
NEUROSCIENCE AND BEHAVIORAL
HEALTH IN AIDS AND HIS TREATMENT
AND WE WILL PUTTING RESOURCES
AND EFFORT TO OUR WAY RECOGNIZE
THE IMPORTANCE OF THESE
BEHAVIORAL APPROACHES TO ENDING
THE EPIDEMIC.
NEXT SLIDE.
ADRIENNE HAW LET STEPPED DOWN
FOR THE NIH OFFICE OF
LEGISLATIVE POLICY AND ANALYSIS.
ADRIAN HAS BEEN A REAL ADVISER
TO THE LEGISLATIVE ADVISER HERE
AND HELPING US ACHIEVE OUR GOALS
WITHIN CONGRESS AND I'VE TOLD
YOU ABOUT THE WONDERFUL
INTERACTIONS WE'VE BEEN HAVING
OVER THE LAST COUPLE OF YEARS
AND THE MENTAL HEALTH AND I
THINK THAT IS NO SMALL PART DUE
TO ADRIAN'S ADVISE OVER THE
YEARS AND SHE SUCCEEDED BY
LAWYER INHIGGINS WHO IS SERVING
WHILE THE SEARCH IS ON GOING.
SO NOW WE'LL TURN OUR ATTENTION
TO NIMH AND NEXT SLIDE TO THE
STRATEGIC PLAN THAT I MENTIONED
EARLIER.
SO AS YOU ALL KNOW THE STRATEGIC
PLAN IS NOW A LIVING DOCUMENT ON
THE WEB AND WE UPDATED
FREQUENTLY AND AT LEAST ANNUALLY
AND I'LL ALSO OUT IN ADDITION TO
THE UP STATES THERE'S SCIENCE
HIGHLIGHTS AND LINKS AND YOU CAN
SEE THE RESEARCH WE SUPPORT AND
THE RESULTS OF THAT RESEARCH
LinkedIn TO THE DIFFERENT
AREAS OF PRIORITY IN THE
STRATEGIC PLAN.
I'LL POINT OUT THAT WITH THIS
NEW UPDATE IN 2023, THERE ARE
CHANGES.
WE'RE EMPHASISSING NOT THE
COMMITMENT TO FUNDING RESEARCH
AIMED AT REDUCING MENTAL HEALTH
DISPARITIES AND THIS WAS
PREVIOUSLY IN THE PLAN AS A
CROSS PUTTING MEASURE BUT NOW
ELEMENTS OF THESE AIMS ARE IN
SEVERAL DIFFERENT GOALS TO NOTE
THAT THE IMPORTANCE FOR EXAMPLE
IS INEL CONSIDERING DISPARITIES
AND EQUITIES AS WE EXAMINE
MENTAL HEALTH TRAJECTORIES OR
MENTAL HEALTH SERVICES.
WE CHANGED THE TITLE OF THE
FOURTH GOAL SPECIFICALLY FOCUSES
ON SERVICES AS OPPOSED TO OTHER
PORT GOAL ALTHOUGH WE HAVE THE
GAME TO IMPACT PUBLIC MENTAL
HEALTH AND STRENGTHEN
PUBLIC-HEALTH AND WE FELT IT WAS
REALLY EXCLUSIVELY FOCUSED ON
ADVANCING MEMBER HEALTH AND SO
WE WANTED TO REFLECT THE NEED
DISCUSSED THERE UNDER THE
CONTROL AND WE'VE ALSO UPDATED
THE DESCRIPTIONS OF EXISTING
NIMH RESOURCES TO HELP FOSTER
RESOURCE OF DATA SHARING AND
EXPANDED ON OUR INTEREST IN
STUDYING THE IMPACT OF SOCIAL
DETERMINANTS OF HEALTH AND
MENTAL ILLNESS TRAJECTORY.
WE ALSO PUBLISH EACH YEAR A
STRATEGIC PLAN PROGRESS REPORT
AND IS IT HIGHLIGHTS INITIATIVES
FUNDED IN THE PAST YEAR AND HERE
IN THIS YEAR WE TALK ABOUT THE
BRAIN INITIATIVE AND
SCHIZOPHRENIA AND AUTISM
SCREENING AND SUICIDE RISK IN
YOUTH AND A NEW APPROACH TO METH
HEALTH DISPARITY RESEARCH AND
FACTS AND FIGURES ABOUT GRANTS
IN THE PREVIOUS YEARS SO IT'S A
WONDERFUL HANDOUT THAT CAN YOU
SHARE WITH FOLKS WHO YOU MIGHT
WANT TO EDUCATE THE ROLE OF NIMH
IN THE RESEARCH OF THE SYSTEM.
NEXT SLIDE.
IS VERY EXCITED AN INITIATIVE
THAT YOU APPROVED LAST YEAR THAT
WE CONCEPT CLEARED LAST YEAR IS
LAUNCHED.
THIS IS THE IMPACT OF MENTAL
HEALTH INITIATIVE AS YOU RECALL,
IS THIS IS TO GATHER VARIOUS
TYPES OF DATA BUT ESPECIALLY
DATA ON BEHAVIORAL FUNCTION
ACROSS MULTIPLE DOMAINS AND TO
COUPLE THAT WITH CLINICAL
INFORMATION ABOUT INDIVIDUALS
AND ASK HOW THAT DATA CAN BE
USED TO AIMING PROVE CLINICAL
PREDICTIONS AND TO HELP CLINICAL
DECISION-MAKING.
THE IMPACT INITIATIVE WILL
CREATE A INFORM STRUCTURE IS
BIAS FREE AND INTEGRATES MULTI
MOTTAL DATASETS REPRESENTED
DIVERSE AND AGAINER EYES ABLE
AND THE FUNDING OPPORTUNITIES
INCLUDE OPPORTUNITIES FOR
INDIVIDUAL COHORTS AND FOR A
DATA COORDINATION CENTER THAT
WILL ENSURE THAT THESE DIFFERENT
COHORTS ARE UNITED AND THEY WILL
USE TO POSSIBLE COMMON OUTCOME
MEASURES AND COMMON DATA
STRUCTURES AND APPROXIMATE WE'RE
VERY, VERY EXCITED ABOUT THIS
INITIATIVE.
IS WE WILL EXPAND AND MORE
RAPIDLY IMPLEMENT THESE AND
ADDITIONAL FUNDING OPPORTUNITIES
TO FOLLOW.
NEXT SLIDE.
HOA WE'VE BEEN WORKING HARD AS I
DETAILED TO THIS GROUP WE'VE
BEEN WORKING HARD TO REMEDY
FAILURES IN OUR REVIEW SYSTEM
AND OUR GRAND MAKING SYSTEM TO
ENSURE EQUITY.
WE CAN EX PANNED ON OUR PEER
REVIEW PANEL SO I WILL MAKE A
NAKED PLEA TO EVERYONE LISTENING
TO THIS, IF YOU ARE INTERESTED
IN FUNDING THE BEST MENTAL
HEALTH RESEARCH WE NEED YOU.
WE NEED SCIENTISTS TO VOLUNTEER
AND TO PARTICIPATE ON OUR PEER
REVIEW PANELS SO YOU CAN APPLY
TO BE A PEER REVIEWER FOR NIH
GRANTS AND IT'S A VERY SIMPLE
APPLICATION AND IT'S A WONDERFUL
OPPORTUNITY TO VOLUNTEER YOUR
SERVICE AND IT WILL ENABLE US TO
BUILD A DATABASE OF REVIEWERS
AND THEIR EXPERTISE TO ENSURE WE
KNOW IS OUT THERE ABLE TO REVIEW
IN DIFFERENT YEARS AND MAKE SURE
TO MAXIMIZE OUR PEER REVIEW
PROCESS THROUGH DIVERSITY AND
INCLUSION.
IS FINALLY, LAST TWO YEARS, WE
HAVE AWARDED THE JAMES JACKSON
MEMORIAL AWARD.
NAMED IN Dr. OF JAMES JACKSON
A RENOWNED SOCIAL EYE COL GIFT
AND MEMBER OF THIS COUNCIL AND
IS WE WILL AWARD ANOTHER IS
AWARD THIS YEAR.
NOMINATIONS ARE DUE SOON.
MAY 22nd.
WE SEEK NOMINATIONS FOR
EXCEPTIONAL INTRAMURAL OR
EXTRAMURAL MENTAL HEALTH
DISPARITIES RESEARCHERS AND YOU
CAN VISIT OUR WEBSITE TO LEARN
HOW TO APPLY.
ON TO STAFF NOW. VERY PLEASED
TOANCE NO THE APPOINTMENT OF
Dr. MARY JUNE REWHO HAS BEEN A
PROGRAM OFFICER AT THE NIMH
DIVISION OF RESEARCH AS THE
ASSOCIATE DIRECTOR FOR
PREVENTION AND THIS IS A
CONGRESS LEHMAN DATED POSITION
AND IT'S A POSITION 245 HAS BEEN
AN IMPORTANT ONE FOR US AS WE
SEEK TO DEVELOP BETTER
APPROACHES TO UNDERSTANDING HOW
TO PREVENT MENTAL ILLNESSES AS
OPPOSED TO TREATING THEM AND
MUCH OF OUR WORK HAS BEEN
ADVANCED IN THIS AREA BECAUSE OF
DIRECTORS INCLUDING EVE RIDER
WHO DID AN OUTSTANDING JOB.
Dr. RUDY WILL BE OUR
REPRESENTATIVE TO NIH OFFICE OF
DISEASE PREVENTION AS WELL AS
OTHER VARIOUS OTHER COMMITTEES
ON WHICH NIH GETS TO WORK IN
PREVENTION INITIATIVES.
IS Dr. KAREN BURR MAN CHIEF OF
THE CLINICAL AND TRANSLATIONAL
NURSE SCIENCE BRANCH AND NEURO
IMAGES AND PSYCHOSIS STUDY
SECTION IN OUR INTRAMURAL
RESEARCH PROGRAM HAS OVER HER
CAREER ACHIEVED ACCOLADES
INCONCLUDING OF COURSE, THE
NATIONAL ACADEMY OF MEDICINE AND
SHE WAS A FELLOW OF THE AMONG
ASSOCIATION ADVANCE OF THE
SCIENCE CONGRATULATIONS TO HER.
AND OPPORTUNITIES ALL GOOD NEWS.
WE'RE SAD TO ANNOUNCE THE
PASSION OF TWO REALLY STALWARTS
OF OUR INTRAMURAL PROGRAM IN
APRIL LAST MONTH.
Dr. BARRIE KAPLAN AND Dr.
EDITHA NOTTELMANN.
THEIR PRESENCE WILL BE MISSED.
LET'S TURN OUR ATTENTION TO SOME
SCIENCE AND AS ALWAYS I WANT TO
THANK THE MANY CONTRIBUTIONS
THAT WERE SUGGESTED FOR
HIGHLIGHTING HERE BY OUR PROGRAM
STAFF AND OUR COLLEAGUE.
I ONLY HAVE TIME FOR TWO OF THEM
TODAY SO I'LL TURN OUR ATTENTION
TO EACH OF THOSE IN BETWEEN AND
THEY DO COVER THE BREADTH OF
RESEARCH THAT WE HAVE HERE AT
LEAST FROM MOLECULAR TO SERVICES
NEXT SLIDE.
THE FIRST ONE IS IN THE
NEUROSCIENCE DOMAIN AND THE IS
TITLE MIGHT CONFUSE YOU AND
FRANKLY THE ARTICLE CONFUSED ME
UNTIL I DOUG INTO IT.
THIS IS WORK THAT COMES OUT OF
REALLY COLLABORATION BETWEEN
DAVID ANDERSON AND ANN KENNEDY
AND IT WAS CARRIED OUT BY A
NUMBER OF INVESTIGATORS AND
THESE ARE FOLKS WHO HAVE GONE
BRAIN INITIATIVE FUNDING AND
NIMH FUNDING AND THIS RESEARCH
IS STUDYING AN IMPORTANT PROBLEM
FOR US TO ADDRESS WHICH IS
AGGRESSION IN THE COP TEXT OF
MENTAL ILLNESS AND IT'S OF IS
CONCERN IN TERMS OF INDIVIDUALS
WHO HAVE BEEN THE VICTIM OF
VIOLENCE OR NOT VICTIMS BY
VIRTUE OF THEIR ILLNESS CARRY
OUT VIOLENT ACTS AND SO IT'S
IMPORTANT THAT WE UNDERSTAND THE
NEUROBIOLOGY UNDERLYING
AGGRESSIVE BEHAVIOR AS MANY OF
YOU KNOW, WE HAVE FORMULATED
NIMH'S APPROACH WHICH LOOKS AT
THE INTERSECTION OF MENTAL
ILLNESS AND AGGRESSION AND
VIOLENCE IN THE FORM OF A NOTICE
TO OUR INVESTIGATORS AND WE FEEL
IT ADHERES TO THE PRINCIPLES
IDENTIFIED IN THAT NOTICE.
ALTHOUGH WE'RE LOOKING AT
AGGRESSIVE BEHAVIOR THE FOCUS IS
A WAY TO ANALYZE NEURO DATA AND
TO UNDERSTAND HOW NEURONS DRIVE
BEHAVIOR SO ALTHOUGH WE THINK
IT'S SOMETHING WE WANT TO
UNDERSTAND IN TERMS OF BEHAVIOR,
AGGRESSION FOR THE PURPOSE OF
THIS PAPER, IS JUST A BEHAVIOR.
WE HAVE TO BE TALKING ABOUT IT
RATIONALLY.
THE MOTIVATION FOR THIS WORK
COMES FROM EARLY RESULTS FROM
LABS INCLUDING THE LABS THAT
COLLABORATE ON THIS GROUP THAT
SHOW A CERTAIN SUBSET OF NEURONS
IN A STRUCTURE DEEP WITHIN OUR
BRAIN, NOT I'M PULLING ONE OUT
FROM A PRIOR ART CALLS NOT THE
ONE WHERE WE'RE CONCERNED WITH
HERE, SHOWING IF YOU TAKE A
MOLECULE THAT IS ABLE TO
ACTIVATE NEURONS SHOULD YOU
SHINE LIGHT ON THAT MOLECULE AND
IT'S EXPRESSED WITHIN THESE
NEURONS, THIS SUBSET OF NEURONS
IN THE HYPOTHALIMUS, AND YOU
SHINE LIGHT ON THOSE NEURONS,
YOU CAN GET DIFFERENT BEHAVIORS
OUT OF THE MOUSE WHEN YOU EXCITE
THOSE NEURONS INCLUDING A
MOUNTING BEHAVIOR WHICH CAN BE
SEXUAL OR DOMINANCE, DEPENDING
WHETHER IT'S TO AN INDIVIDUAL OF
THE SAME OR OF THE OPPOSITE SEX.
YOU CAN ALSO GET AN ATTACK
BEHAVIOR WHICH IS FRANKLY A
VIOLENT ACT AND OR MIXED
BEHAVIOR AND YOU WILL SEE THE
MOUNTING IN GREEN, YELLOW AND
IT'S AN ATTACK AND THE FREQUENCY
OF THE ATTACK BEHAVIORS
INCREASES WITH THE STRENGTHS OF
ACTIVATION OF THOSE NEURONS
WITHIN THE OF HYPOTHALIMUS SO
THIS IS THE OBSERVATION AND THE
QUESTION IS, OKAY, SO THIS IS
WHAT HAPPENS WHEN YOU
ARTIFICIALLY ACTIVATE THIS
SUBSET OF NEURONS IN THE BRAIN
REGION IT SUGGESTS THAT THAT
BRAIN REGION IS IMPORTANT FOR
NATURAL PATTERNS OF AGGRESSIVE
BEHAVIOR AND HOW IS IT
IMPORTANT?
CAN WE UNDERSTAND HOW IT'S
IMPORTANT.
THE NEXT STEP IN NEUROSCIENCE IS
TO RECORD ACTIVITY FROM THOSE
NEURONS DURING BEHAVIOR.
SO THAT'S THE FIRST EXPERIMENT
DOES IN THIS PAPER AND HERE IS
A, WHAT LOOKS LIKE A BEWILDERING
GRAPH BUT IT'S ESSENTIALLY A
ZEST RECORDING FROM MANY NEURONS
AND EACH IS A COLUMN IN THIS
GRAPH FROM TWO DIFFERENT BRAIN
REGIONS ON THE LEFT SIDE OF THE
WHITE LINE IS A DAVE BRAIN
REGION AND THE SECOND IS 9 VEN
RAL MEDIAL HYPOTHALIMUS AND IT'S
IS A NEURON AND EACH ROW IS A
PARTICULAR BEHAVIOR THAT THE
ANIMAL IS ENGAGE IN AND THE
BRIGHTNESS OF THE COLOR
INDICATES WHETHER THE NEURON IS
ACTIVE OR NOT DURING THAT KIND
OF BEHAVIOR.
AND IN ARE I WANT YOU TO FOCUS
ON THE DIFFERENCES BETWEEN THE
LEFT AND THE RIGHT SIDE OF THE
GRAPH.
THE LEFT SIDE OF THE GRAPH, YOU
SEE LITTLE BLOCKS OF BRIGHTNESS.
WHAT DOES IT MEAN?
IT MEANS THAT FOR THE MOST PART,
A NEURON IS ACTIVE IN ONE OR A
HANDFUL OF BEHAVIORS AND NOT
ACTIVE IN THE OTHER BEHAVIOR AND
WE CALL IT A FORM OF SELECTIVITY
AND ONE CAN SAY, THERE'S A
NEURON THAT IS ACTIVE DURING AND
MAY BE RESPONSIBLE FOR
APPROACHED BEHAVIORS OR
SOMETHING CALLED INTERMISSION
BEHAVIOR WHICH IS A SEXUAL
BEHAVIOR IN FEMALES.
IN MALES, YOU CAN SEE THAT IT
MIGHT BE APPROACHED OR ATTACK
SOME OF THE YELLOW SQUARES THAT
YOU SEE ON THE RIGHT-HAND SIDE
OF THAT LEFT-HAND BLOCK OF
ACTIVITIES.
NOW IF YOU LOOK ON THE RIGHT
SIDE OF THE WHITE LINE IN THE
ACTIVITY IT'S A DIFFERENT STORY.
YOU SEE THAT MOST OF THE NEURONS
ARE INVOLVED OR ACTIVE DURING
MANY DIFFERENT BEHAVIORS.
AND SO WE CALL THIS MIXED
SELECTION ACTIVITY.
HOW CAN MIXED SELECTION ACTIVITY
GIVE YOU A RESULT LIKE WE JUST
SHOWED YOU BEFORE.
WHEN YOU ACTIVATE THOSE NEURONS,
AND YOU ACTIVATE THEM STRONGLY
ENOUGH YOU GET A SPECIFIC
BEHAVIOR.
NEXT SLIDE.
SO IN ORDER TO LOOK AT THIS,
THEY LOOKED A LOT THE ACTUAL
DYNAMIC OR CHANGES IN TIME, IN
ACTIVITIES IN THESE NEURONS SO
THEY REPORTED THOSE SAME NEURONS
AND IT'S THE SAME NEURONS BUT
NOW WE ANALYZE THEM DIFFERENTLY.
WE LOOK NOT AT THE ACTIVITY OF A
INDIVIDUAL NEURON IN CAN I
BEHAVDIFFERENTBEHAVIOR BUT ALL D
COLLECTIVELY AND HOW THAT
DIFFERENT TEE CHANGES FROM
MILLEY SECOND TO MILL A SECOND.
SO NOW WE CAN SEE ILLUSTRATED
EACH NEURON IS NOW A ROW AND THE
ACTIVITY OF THAT NEURON OVER
TIME IS ILLUSTRATED IN THE
BLUE-LINE AND SOME GO UP AND
DOWN AND OTHERS GO DOWN THERE
AND UP HERE AND IT IF YOU
IMAGINE, WE CAN DISPLAY THEIR
ACTIVITY ALL SIMULTANEOUSLY AND
WE CAN SAY THAT THE ACTIVITY AND
THE WHOLE NEURAL POPULATION IS
CHANGING OVER TIME.
IT'S MOVING THROUGH A MULTI
DIMENSIONAL SPACE OVER TIME AND
THAT'S ILLUSTRATED IN THE RIGHT
HAND HERE IS A GRAPH, IF YOU
WILL, OF ALL OF THE NEURONS AS
IT CHANGES OVER TIME AS THE
ANIMALS BEHAVE.
OF COURSE, WE CAN'T SEE IN
MULTIPLE DIMENSIONS WE CAN ONLY
SEE IN THREE AND REALLY ONLY
WELL IN TWO WHEN WE LOOK AT A
JOURNAL ARTICLE SO WE'LL
REPRESENT THAT ACTIVITY AS A
MOVEMENT THROUGH SPACE IN TWO OR
THREE DIMENSIONS.
SO HERE IS ONE OF THOSE
DIMENSIONS ILLUSTRATED AND THEY
LOOKED FOR A DIMENSION THAT
CORRELATED WITH THIS ATTACK-LIKE
BEHAVIOR AND SO THIS IS NOT
LOOKING AT SUBSETS OF NEURONS
IT'S LOOKING AT A PARTICULAR WAY
THE NEURONS CHANGE IN TIME AND
TO SEE WHETHER ONE OF THOSE WAYS
CORRESPONDS WITH A THE ATTACK
AND THIS ONE DIMENSION WHICH HAS
VERY SLOW DYNAMICS, IT CHANGES
VERY SLOWLY IS ASSOCIATED WITH
ATTACK SO YOU CAN SEE THAT
REPRESENTS IN THE MIDDLE GRAPH
ON THE Y AXIS AND TIME IS ON THE
X AXIS AND THE LITTLE BOUTS OF
ATTACK ARE ELEVA ILLUSTRATED BYE
RED BAR AND IF THERE'S AN ATTACK
IT'S HIGH AND IF NOT IT'S LOW.
WHAT YOU CAN SEE, THIS IS HOW
QUANTIFY ON THE RIGHT-HAND SIDE
WHERE YOU SUM UP ATTACKS AND
OTHER KINDS OF BEHAVIOR YOU CAN
SEE THAT WHEN THE ANIMALS ENGAGE
IN ATTACK THIS DIMENSION OF
ACTIVITIES IS VERY, VERY HIGH
AND WHEN IT'S ENGAGE IN OTHER
BEHAVIOR IT'S LOWER.
NOW, THERE'S ANOTHER WAY TO
THINK ABOUT THIS.
WHICH IS TO SAY, THAT YES, IT'S
ATTRACTIVE TO THE DIMENSIONS BUT
CAN WE LOOK AT THE SHAPE OF THAT
TRACK THROUGH DIMENSIONS AND
ALTHOUGH THERE'S MULTIPLE
DIFFERENT SHAPES THAT ARE
POSSIBLE, THERE ARE TWO THAT
REALLY EXCITE BEHAVIORISTS WHEN
THEY'RE TRYING TO MAP NEURAL
ACTIVITY AND THEY'RE CALLED A
TRACTORS.
WELL YOU CAN SEE IF YOU LOOK AT
THE BOTTOM GRAPH HERE THERE ARE
WAYS THAT NEURAL ACTIVITY WILL
FLOW OVER TIME SO ONE OF THOSE
WAYS IS A POINT ATTRACT OR WHERE
IF YOU IMAGINE THAT SOME TOTAL
OF NEURAL ACTIVITY IS IN THE
MULTI DIMENSIONAL SPACE RIGHT
BUT WHERE IT IS IN THAT MULTI
DIMENSIONAL SPACE DUE TO THE
EFFECTS OF WE CAN CALL IT
GRAVITY, IT'S GOING TO FALL INTO
THE MIDDLE TO A PARTICULAR POINT
SO THE WHOLE NEURAL NETWORK IS
SET UP TO DRIVE TO A SINGLE
POINT IN STATE SPACE AND A
SINGLE KIND OF PATTERN OF
ACTIVITY SO EVERYWHERE YOU ARE
IN THAT SPACE YOU ARE MOVING TO
ONE POINT IT'S CALLED A POINT OF
TRACK.
THAT'S USEFUL IF YOU WANT TO GET
SOMEWHERE AND STAY THERE.
BUT NOT IF YOU WANT TO EVOLVE A
PATTERN OF ACTIVITY OVER TIME.
THEN YOU NEED A LINE ATTRACTER.
WHERE YOU ARE IN THE SPACE YOU
ARE GOING TO SOME PLACE IN A
TROUGH THAT TUNNELS YOU ALONG
THAT TROUGH AND SO THAT YOU
START OUT WHERE YOU START ON
THAT LITTLE V-SHAPED THING YOU
GO FIRST TO THE TROUGH AND THEN
YOU GO ALONG THE TROUGH AND WHAT
THAT WOULD DO IS CAUSE THE
NEURONS TO FORM A CHANNEL OR
PATTERN OF ACTIVITY THAT GOES
ALONG A PATTERN TO EVOKE A
SERIES OF BEHAVIORS.
AND THAT IS WHAT HAPPENS IN THE
SAME TEST AND YOU CAN SEE THAT
ACTIVITIES STARTS FAR AWAY FROM
THE DOTTED LINE WHICH IS LIKE
THAT TRAM IN A LINEAR A TRACK
TER AND IT MOVES TOWARDS THE
LINE AND THEN MOVES ALONG THE
LINE AS THE ATTACK CONTINUES.
WHEN IT'S OVER IT GOES OFF THE
LINE AND OF IT GOES BACK TO THE
LINE AND MOVES ALONG THE LINE AS
THE ATTACK IS NOTED.
NEXT SLIDE.
THE STRENGTH, THE DEGREE TO
WHICH THE NEURONS ARE FORCED
INTO THIS LINE, IS RELATED TO
THE DEGREE TO WHICH THE MOUSE
SPENDS TIME ATTACKING SO THE
STRENGTH OF THIS LINEAR A TRACK
TER DETERMINES HOW MUCH ATTACK
THE MOUSE IS ENGAGE IN.
IT'S PART OF OF A LONG LINE OF
RECOGNIZE THE IMPORTANCE OF
NUMBER ONE OF MULTIPLE O
MULTIPLE NEURONS COOPERATE TO GO
DO A BEHAVIOR AND WE LEARNED
THROUGH THE BRAIN INITIATIVE WE
CAN'T JUST STUDY A SINGLE NEURON
OR A SMALL GROUP OF NEURONS WE
HAVE TO STUDY PATTERNS ACROSS
MULTIPLE NEURONS AND NUMBER TWO,
IT IND INDICATES THE IMPORTANCE
OF CHANGES OVER TIME IN A NEURAL
SYSTEM AND WE CAN'T CONCERN
OURSELVES JUST WITH LOOKING AT
WINDOWS AND TIME, JUST LIKE WE
HAVE TO LEARN HOW THOUGH UNFOLD
OVER TIME AND BEHAVIOR AND
NUMBER THREE THAT WE CAN LEARN
DETAILS CAUSE PSYCHIATRIC
RELATIVE BEHAVIORS DOING THESE
COMPUTATION ALANAL SIS AND NOW
WE IMAGINE, WELL, LET'S JUST
SHUT OFF ACTIVITY WE MIGHT BE
ABLE TO HELP PEOPLE WHO HAVE
PROBLEMS WITH AGGRESSION AND
LET'S SAY SEVERE DISORDER WHO
ACTS OUT VIOLENTLY AND HERE WE
LEARN OF COURSE, WE KNOW THAT
THE HYPO THAT WILL MISS IS
IMPORTANT FOR THINGS THAT ARE
IMPORTANT.
IF WE DON'T TURN IT OFF WE DON'T
KNOW WHAT DAMAGE WE WOULD DO BUT
WE CAN IMAGINE IDENTIFYING
PERIODS OF TIME DUE TO THE
DYNAMICS OF THE NEURON WHERE AN
INDIVIDUAL MIGHT BE SLIPPING
INTO THIS TROUGH AND DISRUPTING
THAT TROUGH IN SOME WAY AND IS
LOTS OF THINGS WE CAN LEARN FROM
THIS PAPER AND I THOUGHT IT WAS
WONDERFUL TO HIGHLIGHT AND I
WANT TO THANK OUR STAFF WHO
SUGGESTED IT TO ME.
1 LET'S GO TO THE OTHER END OF
OUR SPECTRUM OF RESEARCH AND
LET'S TALK ABOUT AN EFFORT TO
IMPROVE ACCESS OF CARE AND TO
INDIVIDUALS AND TODDLERS WITH
AUTISM IN THEIR FAMILIES.
THIS IS IMPORTANT.
FOR SEVERAL DIFFERENT REASONS.
NUMBER ONE, WE KNOW EARLY ACCESS
TO CARE FOR INDIVIDUALS WITH
AUTISM MATTERS AND IT MALTERS
BECAUSE THEY WILL DO BETTER IN
THE LONG RUN AND IT MATTERS
BECAUSE THEY ARE MORE AMENABLE
TO THERAPY, IT MATTERS BECAUSE
WE WANT TO TRY TO IDENTIFY AND
RESCUE LANGUAGE IN PARTICULAR
BECAUSE LANGUAGE IS AN IMPORTANT
OUTCOME.
IT WILL ENSURE SUCCESS IN
DOMAINS IN LIFE AND THE EARLIER
WE CAN INTERVENE THE BETTER.
NUMBER TWO, THERE ARE
DISPARITIES, FORTUNATELY IN THIS
COUNTRY NARROWING DISPARITIES
AND WE'RE LEARNING SOMETHING
FROM THIS ABOUT WHY PERHAPS BUT
THERE ARE DISPARITIES THE AGE IN
WHICH WE DIAGNOSE INDIVIDUALS
WITH AUTISM AND WE DIAGNOSE THEM
LATER IN MINORTIZIED INDIVIDUALS
AND THE OUTCOMES MAY BE WORSE
AND SO WE NEED BETTER MOLDS TO
IDENTIFY AND REFER INDIVIDUALS
WITH AUTISM AND SCREENING MODELS
BECAUSE O IT CAN BE DIFFICULT TO
RECOGNIZE AUTISM TODDLERS.
WE SUPPORT BOTH AT NIMH AND THE
CENTERS OF EXCELLENCE MOST OTHER
INSTITUTES AT NIH SUPPORT
RESEARCH INTO THE MODELS OF
SCREENING AND ONE OF THEM THAT
WE SUPPOSE SORT THIS GET SET
EARLY PROGRAM WHICH INVOLVES A
DIGITAL APPROACH AS WELL AS
QUESTIONNAIRES TO THE FAMILY
MEMBERS AND THEY'RE DONE IN
PRIMARY CARE SETTINGS AND THIS
IS A TEST OF THIS PROCESS.
NUMBER ONE IT'S A TEST TO SEE
WHETHER IT WORKS AND IT'S A TEST
TO SEE WHETHER IT WILL REDUCE
DISPARITIES AND NOT JUST DIS PAR
TIES IN IDENTIFICATION BUT LATER
ON DISPARITIES IN ACCESS TO
CARE.
SO IT LOOKED AT THOUSANDS OF
SCREENS IN THE SAN DIEGO AREA
AND IN A POPULATION THAT
INCLUDES LARGE NUMBERS OF
HISPANICS.
ASKED WERE WHETHER THIS MODEL
WITH BILINGUAL CAPABILITIES AND
WILL RESULT IN EARLY
IDENTIFICATION OF RISK AND
EARLIER REFERRAL AND DIAGNOSIS
AND APPROXIMATE BETTER CARE.
THIS IS A SCHEMATIC OF THE OVER
ALL PROCESS AND THE ENGLISHES OF
THE NOT INTERVENTION IN A REAL
WORLD SETTING SO WE DON'T HAVE A
CONTROL IN THIS STUDY BECAUSE WE
ALREADY KNOW THIS WORKS AND THIS
IS AN IMPLEMENTATION STUDY AND
IT'S A DISPARITY STUDY.
WILL IT WORK WELL FOR
INDIVIDUALS OF DIFFERENT RACIAL
AND ETHNIC BACKGROUNDS SO THE
RESULTS OF THIS STUDY ARE
INTERESTING AND CONCLUSIVE AND
LESS SO SO FIRST ON THE
LEFT-HAND SIDE YOU SEE THE
AVERAGE SCREENING AGE IN THE
CONTEXT OF THE GET SET EARLY
MODEL IN REAL WORLD SETTINGS AND
BROKEN OUT WITH ETHNICITY AND
RACE AND YOU SEE THE AVERAGE AGE
AT WHICH TODDLERS ARE SCREENED
WITH THE GET SET ARTICLE PROGRAM
AND IT'S BETWEEN 16 AND 17
MONTHS AND RIGHT GO 17 MONTHS
AND THAT IT'S MORE OR LESS THE
SAME FOR DIFFERENT RACES AND ETH
NICE TEASE AND IF YOU LOOK AT
THEY WERE SET FOR AN EVALUATION.
MOST BUN ALL WERE DONE AT THE
UNIVERSITY OF CALIFORNIA SAN
DIEGO WHICH OFFERED FREE
EVALUATIONS AND THE CONTEXT OF
THE GET SET EARLY MODEL AND
THERE WERE OTHER COMMUNITY BASED
PLACES WHERE INDIVIDUALS COULD
BE EVALUATED AND SO THE AGE AND
EVALUATION WAS JUST AFTER 20
MONTHS.
IT WAS A THREE MONTH DELAY AND I
DON'T KNOW HOW REALISTIC IT IS
IN OTHER SETTINGS BUT THIS IS
WHAT THEY'RE ABLE TO ACHIEVE IN
SAN DIEGO AND THERE'S VARIANCE
BASED ON ETHNICITY AND RACE BUT
IT WAS NOT STATISTICALLY
SIGNIFICANT EVEN WITH THE LARGE
NUMBERS OF HISPANIC AND
NON-HISPANIC AND WITHIN RACES
YOU SEE THEY'RE VERY SMALL
NUMBERS OF SCREEN POSITIVE
INDIVIDUALS WHO ARE AFRICAN
AMERICAN AND SOME OF THE OTHER
MINORITY GROUPS BECAUSE THIS IS
ONE THAT HAS HEAVY HISPANIC
INCLUSION AND IF YOU LOOK AT THE
AVERAGE TIME WHICH THOSE WHO
EVALUATED POSITIVE THAT IS
RECEIVED A DIAGNOSIS OF AUTISM
PECK TRUMP DISORDER THAT STARTED
YOU CAN SEE THE AGE OF ONSET
DIDN'T DID YOU EVER BETWEEN
HISPANICS AND NO NON HISPANICS D
THE QUANTITY WAS LOWER BUT NOT
SIGNIFICANTLY DIFFERENT IN
INDIVIDUALS FROM HISPANIC
COMMUNITIES VERSUS NON-HISPANIC
COMMUNITIES AND THERE WAS MORE
VARIANCE BY RACE NEW NOTHING
SIGNIFICANT BECAUSE OF THE
SMALLER NUMBERS.
SO THE AUTHORS ARGUE HERE THE
EARLY MODEL IN THE CONTEXT OF
THE SAN DIEGO COMMUNITY CARE
SYSTEM WHICH IS SOMETHING THAT
THEY TALK A LOT IN THE PAPER IS
SUCCESSFULLY ABLE TO ACHIEVE
EQUITABLE SCREENING AND
EVALUATION AND TREATMENT WHEN
IT'S INSTITUTED IN THE CONTEXT
OF CARE.
APPROXIMATE ONE OF THE THINGS
THAT THEY LOOKED AT WAS
ENGAGEMENT LEVELS ANDEL BY RAISE
AND ETHNICITY AND THEY FOUND THE
ENGAGEMENT LEVELS WITH HISPANIC
AND NON-HISPANIC COMMUNITIES DID
NOT DIFFER.
THEY ALSO DIDN'T DIFFER WHITE TO
MINORITY RACES BUT YOU COULD SEE
DIFFERENCES THAT JUST WEREN'T
STATISTIC AND DIG BASED ON THE
NUMBERS.
ALL RIGHT, SO THAT IS IT FOR THE
SCIENCE HIGHLIGHTS AND THE
CONCLUSIONS OF THIS PAPER ARE
EQUALLY PROFOUND AND MORE
DIRECTLY IMPORTANT FOR PUBLIC
MENTAL HEALTH AND YOU CAN IN
REAL WORLD SETTINGS INTRODUCE
UNIVERSAL SCREENING METHODS AND
PRIMARY CARE SETTINGS AND THEY
CAN RESULT IN BETTER EQUITY AND
AT LEAST WITHIN THE HISPANIC
POPULATION HAD MEMBERS TESTIFY
DIAGNOSIS AND ACCESS TO CARE.
APPROXIMATE SO WITH THAT I'LL
CLOSE WITH ANOTHER MENTION AND
WE TALKED ABOUT OUR 70
ANNIVERSARY PROGRAMS.
NEXT SLIDE.
SO, NEXT YEAR STARTING IN
SEPTEMBER 2023, WE WILL
CELEBRATE 75 YEARS OF
TRANSFORMING THE UNDERSTANDING
OF TREATMENT OF MENTAL ILLNESS.
IT WILL BE A YEAR LONG
CELEBRATION WITH SYMPOSIUMS,
LECTURES, SCIENTIFIC MEETINGS
AND STORIES AND OTHER RESOURCES.
I WANT TO NOTE THAT ALTHOUGH
WE'RE CELEBRATING
ACCOMPLISHMENTS WE'RE NOT
WHITEWASHING NIMH HISTORY WE'LL
TALK ABOUT THIS INSTITUTE AND
WHAT WE HAVE ACCOMPLISHED AND
WHAT WE HAVE NOT ACCOMPLISHED
AND WHAT WE NEED TO DO A BETTER
JOB OF BUT I ENCOURAGE YOU TO
LOOK AT THE FULL ACTIVITY AND
RESOURCES THAT WE WILL HAVE NEXT
SLIDE.
THE FIRST ONE I WANT TO ANNOUNCE
IS THE INAUGURAL EVENT THAT WILL
BE A SYMPOSIUM ON
SEPTEMBER 13th THAT WILL HAVE
IN-PERSON AND VIRTUAL OPTIONS
AND WE'LL EXPLORE KEY SAD
ADVANCES IN MENTAL HEALTH
RESEARCH AND SUPPORTED BY NIMH
AND HEAR VISIONARIES, HYPOTHESIS
ABOUT WHAT OUR FUTURE MIGHT LOOK
LIKE.
SAVE THE DATE.
THOSE OF YOU THAT CAN ATTEND
WONDERFUL.
IF YOU CAN'T, JOIN US VIRTUALLY.
THAT'S IT.
I'LL END WITH THIS SLIDE.
YOU CAN LOOK UP MORE ACTIVITIES
ON WEBSITE.
I'LL OPEN IT UP FOR QUESTIONS.
WE'RE OVER 15 MINUTES.
BOY.
I JUST GOT TOO EXCITED.
>>I THINK MY HAND IS UP THERE
FIRST.
I WOULD LIKE TO COMMENT ON IS
THE PROGRESS IN TREATMENT OF
SERIOUS MENTAL ILLNESSES THAT
HAS OCCURRED IN THE LAST FEW
YEARS.
SO, I RECOGNIZE YOU POINTED OUT
OR ACKNOWLEDGE THAT NIMH GETS A
LOT OF CRITICISM FROM THE
CLINICAL AUDIENCE THAT THERE'S
BEEN NO TREATMENT OVER THE LAST
SEVERAL DECADES AND AS I WAS
SITTING HERE, I TOOK A NOTE OF
NEW ADVANCES.
SO, OVER THE LAST COUPLE OF
YEARS, THERE HAVE BEEN SEVERAL
MEDICATION THAT'S HAVE BEEN
APPROVED FOR TREATING SERIOUS
MENTAL ILLNESSES FOR WHICH WE
HAD NO TREATMENTS BEFORE.
SO THIS INCLUDES RECENTLY I
THINK LAST WEEK RICKS PEPPERSOL
FOR PSYCHOTIC AGITATION.
THIS IS A BREAK THROUGH IN THE
TREATMENT OF THIS DISEASE OF THE
WE HAVE NOTHING THAT IS APPROVED
FOR TREATING SIGH COT I CAN
AGITATION.
IT OCCURS AND EVERY HAS A BLACK
BOX SAYING SHOULD AND WE NOW
HAVE NIMH SPENT VAST SUMS OF
MONEY ON INCLUDING SOME TO MY
LEFT, YEARS AGO, TRYING TO
DETERMINE HOW THAT DRUG WORKS.
ANOTHER BREAK THROUGH MEDICATION
IS THE MEDICATION
PEMABANFRIENDSHIPBANFREN TREATMY
PSYCHOSIS AND IT IS APPROVED
SPECIFICALLY FOR TREATING
PSYCHOSIS AND PARKINSON'S
DISEASE AND IS DEVOID OF ANY
SIDE EFFECTS AND FOR INDIVIDUALS
THAT RESPOND TO THIS, IT'S
TRANSFORMATIVE.
ANOTHER MEDICATION THAT HAS
RECENTLY BEEN APPROVED AS IS
BREXANALONE.
WE HAD NOTHING FOR POSTPARTUM
DEPRESSION FOR SERIOUS CASES AND
FOR ANTI-DIE PRESENTS WHICH
DON'T WORK VERY WELL AND NOW WE
KNOW ONE DAY INFUSION,
BREXANALOE IS TREATING WOMEN WHO
SUFFER FROM POSTPARTUM AND
DEPRESSION AND THIS IS
HIGHLIGHTED IN THE "NEW YORK
TIMES" OVER THE WEEKEND.
HIGHLIGHTED WORK FROM FROM UNC D
THIS IS AN INTERESTING MOLECULE.
IT'S A MODULATOR OF GAB A
RECEPTORS AND OF COURSE NIMH IT
AROSE FROM THE NATIONAL
INSTITUTE OF MENTAL HEALTH AND
STEVE PAUL'S LAB MANY YEARS AGO.
AND THE INSTITUTE HAS FUNDED
THAT RESEARCH FOR DECADES
BASICALLY.
AND THE LAST NEW APPROVAL IS
ESKATAMINE FOR TREATING
DEPRESSION, THIS CAME FROM NIMH
FUNDING RESEARCH AT YALE ABOUT
20 YEARS AGO.
SHOWING THAT A SINGLE DOSE OF
KETAMINE IS EFFECTIVE IN
TREATING DEPRESSION.
ALL OF THESE FOUR APPROVED
MEDICATIONS AND THERE ARE
SEVERAL MEDICATIONS THAT ARE
ANTICIPATED TO HAVE APPROVAL
NEXT YEAR.
THE FIRST IS THE NOAM A LEAN A
COMBINATION AND TIE ASPER OWN
FOR SCHIZOPHRENIA AND THIS HAS
ALREADY HAD POSITIVE PHASE 3
CLINICAL TRIALS.
EXTREMELY ROBUST EFFECT.
THIS WILL BE THE FIRST NON
DOPAMINE FOR SCHIZOPHRENIA THAT
WE'VE HAD.
AND NIMH FUNDED RESEARCH AND
SYSTEM PRIMARILY FROM JEFF CON'S
GROUP I THINK.
AGAIN, FOR DECADES.
AND RATIONALE FOR THIS DRUG AND
PUSHING IT ALONG WOULD NEVER
HAVE OCCURRED WITHOUT NIMH'S
SUPPORT.
AND FINALLY WE HAVE MDMA WHICH
WILL LIKELY REVOLUTIONIZE THE
TREATMENT OF POST TRAUMATIC
STRESS DISORDER AND I'LL GO ON
THE RECORD TO SAY THAT.
THERE ARE NOW TWO POSITIVE PHASE
3 CLINICAL TRIALS.
ONE WAS REPORTED IN NATURE
MEDICINE AND THE OTHER HAS NOT
YET BEEN REPORTED PUBLICLY BUT
THE RESULTS HAVE BEEN REPORTED
PUBLICLY.
THEY'RE GOING TO THE FDA.
THEY'RE GOING TO THE FDA IN 2024
FOR APPROVAL.
THIS WILL TRANSFORM HOW WE TREAT
PTSD AND WE HAVE SIL SA
CYBERSECURITY INFOR DEPRESSION
SASIBEN.I WAS THE ONLY INVESTIGR
FUNDED TO STUDY PSYCHEDELICS AND
IT WAS FUNDED THROUGH NIMH.
MANY YEARS AGO I CAME TO THIS
MEETING AS A GUEST AND YOU
HIGHLIGHTED OUR STRUCTURAL WORK
ON THE LSD PSYCHEDELICS WHICH
WAS PUBLISHED.
AT THAT TIME THINK I WAS THE
ONLY, LITERALLY THE ONLY PERSON
FUNDED TO STUDY PSYCHEDELICS AND
FINALLY, THERE'S A BREXANALON
SHOWING POSITIVE RESULTS FOR
DEPRESSION.
SO WE HAVE THESE MEDICATIONS
THAT REALLY ARE TRANSFORMING HOW
PSYCHIATRY IS BEING DONE AND YOU
MIGHT IN YOUR TALKS, YOU MIGHT
HIGHLIGHT THE IMPORTANCE OF NIMH
FUNDING ON THE BASIC MECHANISMS
OF THESE MOLECULES.
YOU KNOW, IF WE DIDN'T HAVE THIS
RESEARCH, WE WOULDN'T HAVE A
CLUE HOW THESE MEDICATIONS
WORKED.
PHARMA IS NOT GOING TO FUND THAT
WORK.
NOW BECAUSE OF THESE
ADVANCEMENTS AND THESE SUCCESS
STORIES, I'M NOW GETTING, I
WOULDN'T SAY WEEKLY BUT I WOULD
SAY OCCASIONAL QUERIES FROM
MAJOR PHARMA, WHO ARE
CONSIDERING GOING BACK TO THAN
THIS SPACE.
AND NIMH CAN TAKE SOME CREDIT
FOR THAT SO I WOULD SAY IN THE
FUTURE, DON'T BE SO HARD ON YOUR
SELF.
>>IT'S WONDERFUL AS I MENTIONED
TO ENSURE THAT WE RECOGNIZE
SUCCESSES.
AND ALTHOUGH THE ONE THAT I
MENTIONED FEATURES THE SUCCESS
THAT'S REALLY ABOUT THE
TRANSFORMATION OF SERVICES, YOU
ARE POINTING OUT SEVERAL
SUCCESSES IN THE RECENT PAST AND
SOON-TO-BE FUTURE THAT WHERE WE
HAVE SOME OF THOSE ADVANCES THAT
HAVE LED FROM NEUROSCIENCE TO
DRUG DISCOVERY.
WE HAVE OTHERS WE CAN CLAIM EVEN
FURTHER BACK, WE'LL TALK ABOUT
IT IN THE CONTEXT OF THE
ANNIVERSARY TO NEUROSCIENCE FROM
PSYCHE SEW AND SOCIAL
INTERVENTIONS AS WELL.
THANK YOU, BRIAN.
>>MARGARITE AA.
>>I HAVE A QUICK QUESTION.
THANK YOU FOR YOUR PRESENTATION.
IT WAS INFORMATIVE.
I KNOW MANY OF US ARE CONCERNED
THAT WE'RE LOSING DIVERSE TALENT
BECAUSE OF THE FUNDING LEVELS
THAT POSTDOCS GET SO I WAS
REALLY EXCITED TO SEE THAT YOU
ALL RECEIVED THOUSANDS OF
RESPONSES TO THE RFI AND I WAS
JUST WONDERING IF YOU KNOW THE
TIMELINE FOR THE WORKGROUP IN
TERMS OF THE WORK THAT THEY'RE
DOING TO LOOK AT THAT DATA AND
THEN MAKE RECOMMENDATIONS?
APPROXIMATE.
>>I THINK THAT THERE WILL BE A
REPORT OUT NEXT MONTH.
I DON'T KNOW WHETHER THAT WILL
INCLUDE SPECIFIC RECOMMENDATIONS
AT THAT TIME.
>> Joshua Gordon: THERE ARE NO
OTHER QUESTIONS OR COMMENTS FROM
THE COUNCIL, I APPRECIATE YOUR
FORBEARANCE.
WE HAVE A PLAN TO RESCUE THE
CONCLUSION OF THE DAY.
WE'LL SEE HOW MUCH TIME WE CAN
MAKE UP IN THE MEANTIME.
NEXT WE HAVE AN ISSUE BEFORE YOU
THAT WE ARE SEEKING YOUR ADVICE
ON.
IT DOESN'T REQUIRE A VOTE.
BUT WE WOULD LOVE TO HEAR FROM
YOU.
AND FOR OTHERS IN THE COMMUNITY
AS WE LEARN ABOUT THIS.
I'M GOING TO PROVIDE AN
INTRODUCTION AND THEN I'M GOING
TO TURN IT OVER TO Dr.
JOHNATHAN PERCENTNER TEAM LEAD
FOR OUR GENOMICS TEAM IN JUST A
MOMENT BUT BEFORE I DO THAT, LET
ME GIVE YOU A LITTLE BIT OF
BACKGROUND HERE.
SO AS YOU ALL KNOW, THERE WAS A
WORKGROUP OF THIS COUNCIL SOME
YEARS BACK THAT RECOMMENDED THAT
NIMH REVAMP OUR APPROACH TO
GENOMICS IN GENERAL AND
SPECIFICALLY THAT WE ONLY --
THAT IN ORDER FOR US TO FUND
RESEARCH NA IS BASED ACHIEVE A
CERTAIN LEVEL OF STATISTICAL
CONFIDENCE THAT THAT GENE IS
LINKED TO THE DISORDER THAT
PURPORT TO BE STUDYING THROUGH
THEIR APPLICATION, OTHERWISE WE
CAN STUDY ANY GENE OR PROTEIN OR
BIOLOGICAL PROCESS THAT YOU LIKE
BUT ONLY FROM A SCIENCE
STANDPOINT AND IT'S LINKED TO A
IT IS ORDER AND THIS HAS BEEN A
REALLY IMPORTANT DEVELOPMENT AND
IT'S A LOT OF THE DECISIONS I
HAVE MADE AND MY STAFF HAS MADE
AND YOU HAVE ALL CONFERRED WITH
OVER THE YEARS AND ONE REFRAIN
FROM RESEARCHERS WHO HAVE BEEN,
YOU KNOW, DOWNGRADED IN THEIR
PRIORITY FROM RESEARCH AND YOU
DON'T WANT ME STUDYING GENE X,
WHAT GENE SHOULD I BE STUDYING?
SO WE, LET'S SAY I'VE BEEN
ASKING VARIOUS MEMBERS OF OUR
STAFF THAT TO HELP ME WITH A
LOOSE TO THIS PROBLEM AND TO
COME UP WITH THE THE POLICY THAW
MUST PROPOSE A STUDY ON A GENE
ONLY IF IT IS ACHIEVED GENE WISE
SIGNIFICANCE AND WE WANT TO
PROPOSE A IS CAROLE TO OUR
COMMUNITY THAT HERE IS A LIST OF
GENES THAT WE HAVE RELATIVELY
HAD HAVE ACHIEVED THAT
SIGNIFICANCE AND IT'S NOT AN
EXAUSTIVE LIST AND IT'S NOT ALL
GENES BECAUSE WE'RE NOT ALL
KNOWING AND ALL SEEING AND IT'S
NOT MEANT TO BE ON THIS LIST.
YOU CAN'T APPLY TO STUDY IT BUT
IT'S A LIST OF SUGGESTIONS THAT
WE CAN GIVE OUR COMMUNITY TO SAY
IT'S ACCEPTS AND GENES AND
HAVING GENE WIDE SIGNIFICANCE
AND NOT ONLY THAT, WE'RE
PROPOSING A LIST BUT WE'RE ALSO
PROPOSING A COMPANION DOCUMENT
AND IT EXPLAINS THE REASONING
AND SAYS TO OUR INVESTIGATORS IF
YOU HAVE A GENE THAT'S NOT ON
THIS LIST USE THIS REASONING AND
DEFINANCED YOUR DECISIONS TO
STUDY IT IF YOU USE A GENETIC
JUSTIFICATION SO THAT IS THE
BACKGROUND.
THAT'S WHAT I ASKED JOHNATHAN TO
COME UP WITH AND I'M GOING TO
TURN IT OVER THE I BELIEVE YOU
ALSO HAVE RECEIVED AND THEY
RECEIVED THE LIST, NO, THEY HAVE
NOT.
WE CAN PROVIDE IT LATER AND ALSO
THE COMPANION DOCUMENT IF YOU'D
LIKE TO REVIEW IT TO HELP US
MAKE SURE YOU ARE GETTING THE
RIGHT MESSAGE ACROSS.
JOHNATHAN.
>>THANK YOU.
I'M HAVING THE SLIDES.
IS HOW WE CREATE AND MAINTAIN
THE LIST AND HOW THE LIST MAY BE
USED AND THE PROGRAMMATIC STAFF
AND THE RESEARCH COMMUNITIES AND
IS Dr. OR JORD ON AS OUTLINED
A CHALLENGE WE FACE AND AND EACH
STAFF MAY REFER THAT
INVESTIGATOR TO THE 2018 REPORT
OF THE NATIONAL ADVISORY MENTAL
HEALTH COUNCIL WORKGROUP ON
GENOMICS AND DOCUMENT IT'S NOT
RESPONSIVE AND THAT P.I. MAY NOT
BE FAMILIAR WITH THE CRITERIA WE
USE AND TO DECIDE OR DETERMINE
WHETHER A PARTICULAR STUDY OF A
GENE IS RESPONSIVE AND OFTEN
PROGRAM STAFF DO NOT HAVE A WAY
TO RECEIVE FEEDBACK FROM THE
COMMUNITY.
SO WE'RE TRYING TO ADDRESS THAT
HERE IN THE NEXT SLIDE, PLEASE.
THE REPORT OF THE NATIONAL
ADVISORY MENTAL HEALTH COUNCIL
WORKGROUP WAS RELEASED IN 2018.
THAT WORKGROUP RECOMMENDED THAT
NIMH PRIORITIZED ACCORDING TO
RESEARCH ON GENES HAVING
RIGOROUS STATISTICAL SUPPORT FOR
ASSOCIATION TO A MENTAL ILLNESS
AND SPECIFICALLY THEY SHOULD
PASS THRESHOLDS AND IMAGE FROM
THAT WEBSITE WHERE THE
RECOMMENDATIONS WERE POSTED, IS
SHOWN HERE ALONG WITH A LINK.
GIVEN THAT GUIDANCE AND FOR
EXCLUDING PARTICULAR GENES.
SO WE'LL CONSIDER WHETHER AN
APPLICATION ADDRESSES THE
CRITERIA FOR DIGGANCE
RECOMMENDED IN THE COUNCIL GROUP
AS OPERATIONAL IN THE GENE LIST.
NEXT SLIDE, PLEASE.
SO AN OVERVIEW AND THE NEXT
SLIDE, PLEASE.
I WILL START WITH WHAT IT LOOKS
LIKE.
IT'S IN AN XL SPREAD SHEET AND
EACH ROW CORRESPONDS TO A GENE
THAT HAS 5% FALSE DISCOVERY RATE
FOR FDR SUPPORT AND IN SOME
CASES FOR ANY SUPPORT AND THAT
MEANS WHEN WE TALK ABOUT
SIGNIFICANCE THERE'S LENIENT
THRESHOLDS SUCH AS 5% FDR AND
RIGOROUS THRESHOLDS SUCH AS A
CORRECTION AND WE TAKE, WE
RECORD THE INFORMATION ON BOTH
OF THOSE THRESHOLDS AND
CURRENTLY THERE ARE 700 UNIQUE
GOWNS AND 1,000 GOALS AND THE
GOAL IS FOR THE LIST TO BE AS
COMPREHENSIVE AS POSSIBLE AS WE
UPDATE IT OVER TIME.
NEXT SLIDE, PLEASE.
FOR COMMON VARIATION THE
SITUATION IS DIFFERENT.
WE ALSO HAVE A TAB OF AN XL
SPREAD SHEET BUT THEY'RE
IDENTIFIED AND GENOME WIDE
ASSOCIATION STUDIES AND THOSE
SHOW LOW SITE WHICH REQUIRE
STATISTICAL FIND MAPPING TO
IDENTIFY SPECIFIC CAUSAL GENES
AND THEY HAVE 200 GENES FROM
SEVERAL PUBLISHED STUDIES THAT
ARE REPRESENTED OF WELL
SUPPORTED GENES FROM GWAS AS
OPPOSED TO BEING COMPREHENSIVE
IT'S REPRESENTATIVE.
NEXT SLIDE, PLEASE AND THE THIRD
PART IS A WORD DOCUMENT THAT
EXPLAINS THE PURPOSE AND USE OF
THE GENE LISTED.
SO HERE IS A SCREEN SHOT.
WHAT YOU SEE ON THIS PART OF THE
GENE LIST IS A LIST OF GENE
SYMBOLS AND THE OFFICIAL
APPROVED NAMES AND IDENTIFIERS
AND THE STRAITS SUCH AS NDD FOR
NEURAL DEVELOPMENT DISORDERS AND
SUICIDE AND SCHIZOPHRENIA AND
THE E. PERMENT AND THEN THE
SOURCE AND THERE'S A PUBMed
LINK FOR EACH OF THESE.
NEXT SLIDE, PLEASE.
SO, ALL GENES ON THE LIST PASS
5% FDR AS AN INCLUSION CRITERION
AND NEXT SLIDE, SOME OF THEM
PASS FOR STRICT OR THRESHOLD.
SOMETIMES ONE GENE SYMBOL IS
SEEN HERE ON THREE DIFFERENT
ROWS BECAUSE ONE GENE CAN BE
REPRESENTED IN MULTIPLE STUDIES.
NEXT PLEASE.
AND SO APPARENTLY THERE ARE
1,075 GENES.
ON THE NEXT SLIDE WE'LL GO ON SO
I'D LIKE TO ADDRESS THE QUESTION
HOW WAS THIS CREATE AND HOW DO
WE PROPOSE TO MAINTAIN IT?
CREATION WAS ACCOMPLISHED BY A
GROUP OF STAFF.
THERE WERE 14 OF US WHO
SUPPORTED DEVELOPMENT OF THE
GENE LIST.
FOR RARE VARIATION, THE BASIC
WORK WAS TO SEARCH THE
LITERATURE AND FIND SUPPLEMENTAL
TABLES AND PUT THEM INTO A LIST
WITH AN INTENTION TO BE
COMPREHENSION I HAVE AND
INCLUSION CRITERIA WHERE THERE'S
THE 5% OF FALSE DISCOVERY RATE.
SO FOR COMMON VARIATION AS I
MENTIONED, WE ONLY INCLUDE
REPRESENTATIVE EXAMPLES AND IN
THE FIELD THERE'S NO CONSENSUS
ON WHICH SPECIFIC GENES SHOULD
BE NOMINATED FROM MAPPING SO
RATHER THAN ATTEMPT TO DO THAT
TASK, WE SIMPLY SHOW THE KINDS
OF APPROACHES THAT WE FEEL ARE
APPROPRIATE TO TAKE.
NOW, HOW IS THIS GENE LIST
MAINTAINED?
WE HAVE A VERSION NUMBER FOR
EACH LIST AND A DATE AND WE
PROPOSE TO UPDATE IT REGULAR
INTERVALS SUCH AS ONCE EVERY
THREE MONTHS FOR EVERY SIX
MONTHS.
WE WELCOME FEEDBACK FROM THE
COMMUNITY AND EXPECT
INVESTIGATORS TO SUGGEST THE
ADDITION OF MORE GENES FROM
PUBLICATIONS, WE WERE APPROVED
WITHIN E-MAIL ADDRESS AND SO WE
WILL POST THIS ON AN WEBSITE
MAKING IT PUBLICLY ACCESSIBLE
AND THEN WELCOME FEEDBACK
THROUGH THAT' MEAL ADDRESS.
WE INTEND TO INTRODUCE A LIST OF
VARIANTS AS A FUTURE DEVELOPMENT
FOR CNBs THAT ARE ASSOCIATED
WITH MENTAL ILLNESS.
ARE NOW, HOW DO WE ANTICIPATE
THAT THIS GENE LIST WILL BE
USED?
BY PROBLEMATIC STAFF WE EXPECT
TO USE THE GENE LIST CONSIDERING
WHETHER A APPLICATION ADDRESSES
THE CRITERIA FOR SIGNIFICANCE
RECOMMENDED IN THE COUNCIL
WORKGROUP REPORT AND STAFF WILL
ENCOURAGE WELL SUPPORTED GENES
WHEN ASSOCIATION TO A MENTAL
ILLNESS IS CLAIMED AND THIS IS
AS OPPOSED TO CANDIDATE GENES
THAT NOT SUPPORTED.
THE DOCUMENTATION IS LANGUAGE
THAT MAYBE USEFUL TO PROGRAM AS
NIMH STAFF COMMUNICATE WITH
INVESTIGATORS AND I'D LIKE TO
THIS IS NOT AN EXCLUSIVE LIST OF
THE ONLY LIST STUDYING AND A
GUIDE TO THE THINKING OF HOW WE
WANT TO ADHERE TO THE GUIDANCE
OF THE NIMH COUNCIL REPORT.
IT MAY BE USEFUL FOR PLANNING
AND NOTICES OF FUNDING
OPPORTUNITIES AND ONE EXAMPLE IS
THE RECENTLY LAUNCHED GENES TO
BIOLOGY INITIATIVE CALLED SSI
GENE IN WHICH SEVERAL HUNDRED
GENES ARE TO BE STUDIED
FUNCTIONALLY AND THE GENE LIST
WOULD BE HELPFUL IN SELECTING
GREENS FOR A PROJECT LIKE TO AND
HERE, IT MAY MAYING USEFUL FOR
SCIENTISTS WITH EXPERIMENTAL
SYSTEMS OR WELL SUPPORTED HUMAN
RISK GENES.
HOW DO WE THINK THIS -- I'M
GOING A EXAMPLE.
AN INVESTIGATOR PROPOSES
FUNCTIONAL STUDIES THE GENE
AP300 FOR ITS ROLE IN NEURAL
DEVELOPMENTAL DISORDERS WE CAN
LOOK TO THE LIST AND SEE THERE'S
APPROPRIATE GENOME WIDE SUPPOSE
AUTHORITY THIS CASE FROM THREE
SEPARATE STUDIES.
ANOTHER EXAMPLE IS YOU MAY SEE
ENA APPROXIMATE ON THE LIST AND
THEY STUDY ENO4 ENCODING 4.
THAT'S NOT ON THE LIST AND
PROGRAM MIGHT ADVISING THE
INVESTIGATOR THAT NIMH MAY BASIC
RESEARCH STUDIES OF THIS GENE
AND NOT AS A CANDIDATE, OR A
GENE, SIGNIFICANT ASSOCIATION TO
A PARTICULAR NOT PHENOTYPE OR
SUCH AS NEURO DEVELOPMENTAL
DISORDERS.
OF AND NOW APPLICANTS MAY REVIEW
AND THE RECOMMENDATION THAT'S
COME IN THE WORD DOCUMENT AS
THEY PREPARE GRAND APPLICATIONS
INVESTIGATORS THEY SUCK SUCH
SUPPORT AND THEY MAY CHOSE TO
STUDY THE PROPERTIES OF THE
GENES ON THIS LIST FOR EXAMPLE,
THEY MIGHT INTERSECT WITH THE
GENE LIST WITH FDA APPROVED DRUG
TARGETS AND STUDY PLAY
EVOLUTIONARY CONSTRAINT AND FOR
MANY OTHER KINDS OF FUNCTIONAL
ANNOTATION OF THE LIST AND SO
THIS WOULD BE AVAILABLE FOR
ANYONE TO DO THAT.
SO I'D LIKE TO CONCLUDE THE NEXT
SLIDE.
WE HAVE DEVELOPED GENE LISTS FOR
RARE AND COMMON VARIATION AND
THIS IS AN EFFORT ON OUR PART TO
BE RESPONSIVE TO THE 2018
COUNCIL WORKGROUP REPORT ON
GENOMICS AND NIH PROGRAM STAFF
PROPOSES TO OFFER THE GENE LIST
AND DOCUMENTATION VIA PUBLIC
FACING NIH WEBSITE AND MAKING IT
PUBLIC WE'RE TRANSPARENT ABOUT
THE PROCESS BY WHICH WE EVALUATE
GENES.
FOR INVESTIGATORS THE GENE LIST
MAY HELP PREPARE GRANT
APPLICATIONS WITH THE FOCUS ON
WELL SUPPORTED GENES AND FOR
STAFF THE GENE LIST MAY BE
HELPFUL RESOURCE WHEN
PRIORITIZING GRANT APPLICATIONS.
AND FINALLY WE HOPE INTERACT
WITH THE COMMUNITY TO EXPAND THE
GENE LIST OVER TIME AND CORRECT
IT AS NEEDED FOR WHEN WE LOOK
FORWARD TO FEEDBACK FROM THE
COMMUNITY.
I'D LIKE TO END WITH A
ACKNOWLEDGMENT SLIDE OF THE TEAM
THAT WORKED TOGETHER ON THIS
PROJECT AND THIS INCLUDES
MEMBERS OF THE DIVISION OF BASIC
BEHAVIORAL SCIENCE AND THE
DIVISION OF TRANSLATIONAL
RESEARCH, OFFICE OF TECHNOLOGY
DEVELOPMENT AND COORDINATION AND
THE DIVISION OF IRP AND SO THANK
YOU AND I'M HAPPY TO TAKE ANY
QUESTIONS OR HAVE ANY
DISCUSSION.
>> Joshua Gordon: ELLEN.
>>YES, I JUST THINK IT'S A
REALLY INTERESTING RESOURCE TO
HAVE, ESPECIALLY IF WE ALSO
INCLUDED MAYBE INFORMATION ABOUT
SAMPLE SIZE AND THE HOMO GENEITY
OF THE POPULATION AND UNDER
STUDY I KNOW PROBABLY IT COULD
BE OBTAINED FROM THE REFERENCES
YOU PROVIDE BUT WHETHER
DETERMINING A PARTICULAR GENE
HAS REALLY ROBUST FINDINGS IT
WOULD BE ALSO USEFUL TO KNOW IF
IT WAS DONE IN A LARGE ENOUGH
SAMPLE SIZE ON IN A SAMPLE THAT
REPRESENTS THE SAMPLE THAT I'D
LIKE TO STUDY IN MY OWN
RESEARCH.
>>THANK YOU FOR 245 COMMENT.
THAT COMMENT.
WE ONLY HAVE GENES THAT REQUIRES
INADEQUATE SAMPLE SIZE BUT I
WOULD LIKE TO FOLLOW-UP ON YOUR
SUGGESTION AND DO THAT.
WE ACTUALLY CAN, WE ABSOLUTELY
CAN INCLUDE THAT KIND OF
INFORMATION.
IN TERMS OF THE POPULATION, THAT
BOB A LOT MORE WORK AS EACH
STUDY HAS ITS OWN PARTICULAR
SAMPLE BUT NIMH AND OTHER
PROJECTS IS DEEPLY COMMITTED TO
INCREASING OUR UNDERSTANDING OF
ANCESTORIAL DIVERSITY AND
STUDYING MENTAL HEALTH ACROSS
THE GLOBE IN DIFFERENT
POPULATIONS WHERE THE RELEVANCE
OF DIFFERENT GENES MAY DIFFER.
>>I THINK THAT WOULD BE VERY
IMPORTANT AS WE CONTINUE UP TO
DATE THE LIST TO MAKE SURE THAT
WE -- THAT IT BECOMES MORE
INCLUSIVE OF GENES THAT ARE
RELEVANT TO MORE THAN JUST THE
CAUCASIAN POPULATION, WHICH IS
THE PRIMARY SOURCE FOR MUCH OF
THE DATA THAT IS GOING TO BE
PRESENTED IN THESE LISTS.
>> Joshua Gordon: LAURA --
>>THANK YOU, VERY MUCH.
SO, I AM CURIOUS ABOUT THE
EXACTLY WHAT RARE AND THE
SOURCES OF.
SO, I THINK THAT RARE MEANS, AT
THIS POINT, THE INFORMATION IS
COMING FROM EX ON BASED STUDIES?
IS THAT RIGHT?
WHERE YOU HAVE A CODING VARIANT
IN A GENE OR SOMETHING THAT
LOOKS LIKE IT'S IN THAT GENE.
O.
>>THAT'S RIGHT.
THE DEFINITION TYPICALLY IS OF A
PARTICULAR NOT ALLELE FREQUENCY
CUT OFF IN THE POPULATION WHERE
RARE VARIATION OCCURS AT LESS
THAN 1% POPULATION OF FREQUENCY
AND COMMON FROM GWASS INVOLVES
MORE FREQUENTLY OCCURRING AND
VARIATION SO YES IN THE RARE
VARIATION STUDIES TYPICALLY
INVOLVE FULL EX OWN OR WHOLE FEE
NOAM SEQUENCING AND IT FOCUS ON
GENES WITH BURDEN TESTS.
>>SO THOSE STUDIES ARE NICE IN
THE SENSE THAT YOU REALLY KNOW
YOU THINK YOU KNOW ERRORS OF
BIAS AND WHAT PEOPLE HAVE DONE
YOU HAVE TARGETED RIGHT, AN
ACTUAL GENE SO I THINK THAT THAT
IS A GREAT IDEA.
FOR THE COMMON VARIATION, I
GUESS I WOULD LIKE TO BE ABLE TO
SEE HOW ACTUALLY THOSE GENES
HAVE GOTTEN APPLIED BECAUSE IT
IS HOW THOSE GENES ARE -- LET ME
BACK UP.
WITH COMMON VARIATION YOU DON'T
KNOW WHAT THE GENE IS.
YOU HAVE ALMOST NO WAY TO KNOW
WHAT THAT GENE IS.
RIGHT.
WITH WHAT WE KNOW AT THIS POINT.
PEOPLE HAVE GREEN AND IT'S
REALLY DIFFICULT IT COMES DOWN
TO I THINK STILL A CRAP SHOOT.
>>THANK YOU SO MUCH FOR THESE
QUESTIONS AND ONE TAKES A LARGE
NUMBER OF INDIVIDUALS WHO ARE
EFFECTIVE WITH A CONDITION SUCH
AS 10,000 PEOPLE WITH MAJOR
DEPRESSIVE DISORDER AND 10,000
CONTROLS.
ONE MEASURES DNA VARIATION
ACROACROSS THE GENOME BY SEQUENG
AND ONE IDENTIFIES AND A
CHALLENGE COMES NOT JUST IN
FINDING BOTH SIDES THAT ARE
SIGNIFICANT BUT IN UNDERSTANDING
WHAT GENES ARE IN THOSE LOW SIGH
BECAUSE OF THE PROPERTY OF
LINKAGE LD AND IT MAY BE THERE
ARE 100 GENES IN THE LD BLOCK
AND IT'S NOT ENOUGH TO HAVE A
GENE FROM A PARTICULAR SITE AND
YOU NEED GO ANOTHER STEP OR TWO
AND EXAMPLE OF THAT STEP OR TWO
IS TO ADD AND SOME STATISTICS
RANDOMIZATION AND SMR OR TO ADD
TWASS STUDIES AND EVEN GENOMICS
STRUCTURAL EQUATION MODELING AND
THEY'RE DIFFERENT APPROACHES
THAT ARE TAKING TO GO STEP
FURTHER AND YOU MENTIONED EQTL
AND HAD AND STATISTIC
RANDOMIZATION AND OTHER LAYERS
OF EVIDENCE AS EX POLICE CAR OF
THE KIND OF RIG OR WE'RE LOOKING
FOR.
>>GREAT.
I WOULD SAY THAT HAVING WORKED
SOME WITH IS WHERE IT CAN BE
PUSHED OFF BY A SICKEL VARIANT
THAT HAS A STRONG EFFECT, RIGHT.
THAT MAY NOT HOLD UP WHEN YOU
LOOK AT THAT AND MAYBE IT'S A
LONGER CONVERSATION AT THIS
THINK WOULD YOU FIND THOUSANDS
OF GENES, RIGHT, THAT HAVE THE
EFFECT SO I REALLY APPRECIATE
THE TRYING TO NARROW DOWN AND I
THINK 9 TOOLS IS INCREDIBLY
BLUNT AND NON SPECIFIC IF IT'S.
>>I'LL SAY THANK YOU AND I LOOK
FORWARD TO FEEDBACK ON THE
WRITTEN DOCUMENTATION AND ALSO
PRESENTS OUR APPROACH TO
RECOMMENDING ADDITIONAL STRENGTH
OF SUPPORT TO REDUCE AND IT WILL
BE ONE AND THE MOST IMPORTANT
AND AND THE AT THE MOST
IMPORTANT AND AND I THINK IT
WILL HELP AND I THINK THIS
TRANSPARENT AND PARTICULARLY
IT'S ENCOURAGING TO HAVE DETAIL
FOR A SHORT REPORT AND GENOMIC
WORKING GROUP AND I THINK THAT
THE COMMENTS AND ONE CAN SAY
THAT IN A DIFFERENT WAY AND THAT
IS THAT THE STUDIES THAT WE DO,
LOOK AT THE ASSOCIATION OF
PARTICULAR MUTATIONS THAT ARE
EITHER SNIPS OR SINGLE
NUCLEOTIDE VARIANTS WITH A
DISEASE DIAGNOSIS.
NOW AS YOU TEASE THAT APART
THERE'S A COUPLE OF CHALLENGES
WITH THAT.
THE FIRST CHALLENGE LAURA
POINTED OUT IS THE MUTATIONS MAY
NOT HAVE THE RESOLUTION THAT YOU
WANT AND THEY ALSO MIGHT NOT BE
IN GENES AND THE WORLD IS NOT
AND NOT JUST IS FINDING PROTEIN
AND I KNOW WAY TOO MUCH ABOUT IT
AND BUT, WHAT I WILL SAY AND IF
YOU LOOK AT THE MUTATIONS
THERE'S A GROUP OF MUTATIONS
THAT APPEAR TO BE LINKED TO
INTELLECTUAL DISABILITY AND IT
WAS OTHER MUTATIONS SEEM TO BE
LINKED TO AN AUTISM DIAGNOSIS
ACTUALLY AND THOSE ARE DIFFERENT
DOMAINS OF THE PROTEIN AND THE
QUEEN AND WE MIGHT STUDY A GENE
THAT DOES ONE THING OR ANOTHER
AND IT'S WORTH REALIZING THERE
MAY BE SOME MUTATIONS IN IT THAT
HAVE NOTHING TO DO WITH
PSYCHIATRIC DISEASE AND HAVE TO
DO WITH CRANIAL FACIAL SYMPTOMS
AND CARDIAC SYMPTOMS SO THE
LABEL IS NOT MUTATION AND
FUNCTION, AND THAT IS THE ONE
PART OF WHAT I SAID OF LINKING
MUTATIONS TO DISEASE AND LET'S
TALK ABOUT DISEASE.
AND WELL, JOSH PRESENTED
AGGRESSION.
WE WANT TO UNDERSTAND
AGGRESSION.
BECAUSE AGGRESSION IS IMPORTANT
PART OF A NUMBER OF PSYCHIATRIC
DISORDERS.
IT'S NOT A DISEASE DIAGNOSIS SO
NO GENE ON THIS LIST WILL HELP
US PROVIDE IN SIGHT INTO
AGGRESSION.
BRIAN IN HIS LIST OF THE
ACCOMPLISHMENTS OF NIMH, YOU
WILL NOTE, SAID THAT DRUGS WERE
DEVELOPED NOT FOR SCHIZOPHRENIA
BUT FOR PSYCHOTIC AGITATION OR
INFORM PSYCHOSIS WITH
PARKINSON'S DISEASE AND OR FOR
DEPRESSION THAT IS IN WOMEN
RELATED TO PREGNANCY AND SO ONE
THING I'M CONCERNED ABOUT IN
THIS RESTRICTION IT MAY NOT COME
FROM THIS LIST SO I HOPE IT
DOESN'T BECOME EVERYTHING IS NOT
IMAGINE IN THE PHILOSOPHY OF
THIS LIST AND I HOPE NIMH
REALIZES THAT THAT'S THE CASE
AND I WONDER IF THIS LIST WOULD
HAVE INFORMED US TO LOOK AT THE
MEDIA HYPOTHALIMUS FOR
AGGRESSION OR LOOK AT PARTICULAR
CANDIDATES TO TREAT PSYCHOTIC
AGITATION IN ALZHEIMER'S OR
PARKINSON'S SO I'M A LITTLE
WORRIED WE'RE BUILDING A HOUSE
OF CARDS ON TOP OF SOME THINGS
WE ARE WEARING OF WHAT WE'RE
DOING AND THAT'S THE MOST
IMPORTANT THING AND I WANT TO
SAY ONE LAST WORD AND IT'S
POLYGENIC.
I WANT TO THROW THAT IN THE ROOM
AND IN PARTICULAR, THAT'S WHAT
IS MENTIONED AND THE MAJORITY OF
DISEASE IN THE CASE OF AUTISM
WHICH IS A DIE SEES THAT I LIVE
WITH EVERYDAY WITH OUR SON.
HE IS NOT HAVE A SINGLE GENETIC
MUTATION BUT I'M SURE IT'S
GENETIC IN NATURE BUT IF IT IS
GENETIC IN NATURE IT'S POLYGENIC
IN NATURE SO THINKING ABOUT HOW
WE CAN UNDERSTAND THAT IS
IMPORTANT.
THERE'S A VERY IMPORTANT PAPER
LAST YEAR LOOKING AT THE 16P11
LOCUS WHICH IS A COPY NUMBER
VARIATION THAT WE STUDY IN MICE
AND LINKING IT TO POLYGENIC
COMMON VARIATIONS SO YOU DON'T
SEE IT LINKED TO RARE
VARIATIONS.
SO I JUST WANT TO THROW THE WORD
POLYGENIC INTO SPACE AFTER THAT
AND IT'S A LOT TO SAY AND I'M
LOOKING FORWARD TO THE FUTURE
DISCUSSIONS AND MOSTLY I HOPE
THIS IS A WORK IN PROGRESS THAT
ACKNOWLEDGES OF THE SUBTLE TEE O
ACHIEVE AND WE NOT LIMIT THAT.
>>THANK YOU.
>> Joshua Gordon: THANK YOU FOR
ALL THOSE COMMENTS AND TIME
PERMITTING I'LL GIVE A BRIEF
ANSWER THAT I THINK THAT YOU ARE
COMMENT ABOUT EP300 AND CORRECT
BINDING PROTEIN AND YOU THINK
ABOUT RARE VARIATION BUT ALSO
ABOUT RARE DISORDERS AND THERE'S
SOME CONDITIONS THAT EFFECT
RELATIVELY FEW INDIVIDUALS.
AN EXAMPLE IS MUTATIONS
IDENTIFIED IN 17 INDIVIDUALS FOR
THE LOSS OF FUNCTION ALL 17 HAVE
THE SAME AUTISM-LIKE PHENOTYPE
AND THEY'RE LIKELY TO BE GENES
THAT WILL NEVER REACH
SIGNIFICANCE AND THE MEDICAL
GENETICS WILL LIST THOSE AND
WHICH ARE REALLY A DIFFERENT
EMPHASIS THAN HERE AND IN THIS
CONTEXT, THERE ARE MANY
INVESTIGATORS WHO WANT TO STUDY
GENE AND SUGGEST IT'S FOR AUTISM
OR RELATED TO AUTISM OR
ASSOCIATED WITH AUTISM AND THE
DATA DON'T SHOW THAT SO WE'RE
MAKING SURE THAT THAT WORK IS
PROPERLY CLAIMING SEWIZATION BUT
NOT IN NAME TRYING TO BE
RESTRICTIVE ABOUT STUDYING RARE
VARIATION IN THE GENE, I GUESS,
THE CASE THAT EP300 IS ON THE
LIST.
>>I DON'T KNOW IF IT'S NOT THE
LIST BUT IT SHOWS UP NOW.
SO, YEAH.
>>SO A BROADER IDEA IS WHAT ARE
WE TRYING TO DO?
IT'S ABOUT SCIENTIFIC RIGOR AND
MAKE SURE ONE DOESN'T STUDY A
FAVORITE GENE WHICH SEEMS
APPEALING BUT NOT ASSOCIATED TO
A CONDITION.
IN TERMS OF POLYGENIC THANK YOU
FOR MENTIONING THAT WORD AND
THESE DISORDERS OFTEN ARE IN
TERMS OF BRIAN'S COMMENTS AND
FOR Dr. ROSS IN TERMS OF
PHENOTYPES THAT NEED TO BE
CONSIDERED IN AGGRESSION AND
DIFFERENT KINDS OF AGGRESSION
EVEN AND ONE CAN GO TO HUMAN
GENOTYPE ONCOLOGY AND GET A LIST
OF GENES AND USE THIS LIST TO
UNDERSTAND WHICH OF THOSE
ALREADY HAVE GINO WIDE SUPPORT
TO KNOW WHICH OF THEM MIGHT BE
APPROPRIATE TO STUDY OR MIGHT BE
HELPFUL TO STUDY SO THIS CAN BE
A GUIDE AND I WANT TO AGREE WITH
YOUR COMMENT ABOUT OUR INTEREST
IN BEING TRANSPAR TRANSPARENT AE
ARE MANY DIFFERENT APPROACHES TO
THIS PROGRAM AND THAT WE'RE
SUPPORTIVE OF HEARING FROM THE
COMMUNITY AND FROM COUNCIL NOW
ABOUT BEST WAYS TO GO FORWARD.
>>LET ME JUST EMPHASIZE, THIS
IS AGAIN, IT'S A SET OF MY
INTRODUCTION.
THIS IS NOT MEANT TO BE
RESTRICTIVE.
WE HAVE THAT.
WE HAVE THAT DOWN.
WE RESTRICT ALL THE TIME.
AND IN FACT, UNFORTUNATELY WE
RESTRICT WITHOUT TRANSPARENCY
BECAUSE IT'S REALLY HARD TO
CREATE A LIST OF GENES THAT WE
WON'T STUDY, RIGHT.
THIS IS MEANT TO BE THE OTHER
END OF THE SPECTRUM AND WE WANT
2TO PINT PEOPLE TO GENES AND ITS
NOT MEANT TO BE THE ONLY PIECE
OF INFORMATION TO DEVICE A
STRATEGY FOR STUDYING THINGS.
SO YEAH, IF THEY WANT TO STUDY
EP300 AND SUGGEST A KNOCKOUT
THEY BEST DAMN BE SURE THAT
THAT'S THE RIGHT ONE AND JUSTIFY
THAT ON THE GRANT.
>>THANK YOU, JOHNATHAN.
I APPRECIATE THE PRESENTATION
AND THE FEEDBACK.
WE HAVE SOME DISCUSS ON THE
COMMON VARIATION BETWEEN YOU AND
ME AND BEFORE WE MOVE FORWARD.
>>I JUST A COMMENT AND WE'VE
HEARD COMMENTS AGAINST THIS AND
I THINK THIS IS A GREAT IDEA.
FOR THOSE OF YOU WHO HAVEN'T
SORT FOLLOWED THIS AREA FOR
DECADES, THERE ARE REALLY SORT
OF NOTORIOUS CASES OF GENES THAT
HAVE SOPPED UP VAST SUMS OF
MONEY PARTICULARLY IN MENTAL
HEALTH THAT WERE SHOWN IN GINO
ONE ASSOCIATION STUDIES AND NOT
TO BE ANYWHERE -- NOT TO BE
(INAUDIBLE).
AND I KNOW AS A REVIEWER, WHEN I
WOULD REVIEW THESE GRANTS, I
WOULD HAVE TO DIG INTO THE
PRIMARY LITERATURE MYSELF AND
IT'S GREAT THAT THIS IS HERE NOW
AND SO YOU KNOW AT SOME POINT IN
THE FUTURE, AND ONE OF THE
THINGS THAT WHEEL FROM THIS IS A
LOT OF THE VACCINES LINKED TO
PSYCHIATRIC DISEASES PEOPLE WILL
STUDY THEM BECAUSE THEY'RE ON
THE LIST AND THEY'LL THINK NIH
IS INTERESTED AND SO YOU WILL
SEE GRANTS AND IT'S A GREAT
THING.
>>I APPRECIATE THE POSITIVE
FEEDBACK.
I APPRECIATE THE DISCUSSION
WE'VE HAD SO FAR AND IT WILL BE
AN ONGOING GIVE-AND-TAKE.
JUST A MOTEL A NOTE TO CHRISTOPD
PAULINE, WE HAVE TO POSTPONE
YOUR PRESENTATIONS TO THE NEXT
COUNCIL ON THE KUM PES PROGRAM.
THIS IS REALLY EXCITING PROGRAM
AND WE WILL BRING TO COUNCIL AND
WE WANT YOU ALL TO HEAR ABOUT IT
AND UNDERSTAND THAT NIH ROLE BUT
WE DON'T HAVE TIME TODAY.
WE'RE GOING TO MOVE TO THE NEXT
ITEM ON THE AGENDA WHICH IS
Dr. NITA FARAHANY TO JOIN US
TO TELL US ABOUT A CONSULTATION
BRAIN ETHNIC WORKING GROUP AND
NIH IS ONE OF THE TWO SUITS AND
ONE OF 10 DIFFERENT INSTITUTES
AND SUPPORTS THE BRAIN
INITIATIVE AND THERE'S A STRONG
NEUROETHICS COMPONENT TO THE
BRAIN INITIATIVE AND ONE OF
THOSE COMPONENTS IS TO PERFORM
CONSULTATIONS TO GRANTS AND
PROGRAMS THAT MIGHT RAISE NEURO
ETHICAL ISSUES AND FROM TIME TO
TIME, THOSE ARE DISCUSSED IN THE
WORKING GROUP AND THEY NEED TO
BE PRESENTED AT A OPEN SESSION
OF A COUNCIL IN ORDER FOR BRAIN
STAFF TO BE ABLE TO TAKE THAT
ADVICE AND HAND AND THAT'S WHAT
WE'RE DOING TODAY AND WE'RE
GOING TO HEAR FROM Dr.
FARAHANY AND A CO-CHAIR IN THE
BRAIN NEURO ETHICS WORKING GROUP
AND SHE COMES TO US TO SHARE
SOME CONSIDERATION FROM THAT
GROUP ON SHARING AND ACCESS OF
GENOMIC SEQUENCING DATA AND THIS
IS FOR YOUR AWARENESS.
THERE'S NO VOTE AFTERWARDS AND
Dr. FARAHANY, DID YOU FOR
JOINING IS.
>>AND COULD YOU GO TO THE NEXT
SLIDE, PLEASE.
SO, I WANTED TO BEGIN JUST BY
GIVING YOU AN OVERVIEW OF THE
BRAIN INITIATIVE ATLAS NETWORK
TO THEN GET INTO THE CONTEXT OF
THE CONSULTATION THAT WE DID AND
SO THE OL HERE IS BUILDING
REFERENCE BRAIN DIALYSIS THAT
WILL BE USED THROUGHOUT THE
COMMUNITY WHICH GIVES THE
FOUNDATIONAL FRAMEWORK FOR CROSS
SPECIES STUDY OF BRAIN EVOLUTION
AND FUNCTION AND INVOLVES THE
COLLECTION OF BRAIN SPECIMENS
AND ALLOWS FOR LARGE-SCALE HUMAN
DENOAM I CAN TO BE SHARED AND
UNDER RESTRICTED OR CONTROLLED
MANNER BASED ON WHICH APPROACH
IS INDICATED IN INSTITUTIONAL
CERTIFICATION FORMS THAT ARE
PROVIDED BY THE INSTITUTIONS AND
CURRENTLY THE BUY CAN FOA
STIPULATE LATE DATA TO BE SHARED
VIA OPEN AND UNRESTRICTED ACCESS
AND IT'S THAT POINT WE WANTED TO
FOCUS ON.
SO, NIH OF COURSE NAMES TO HAVE
GOOD DATA STEWARDSHIP WHILE MACK
HIMAXIMIZINGDATA SHARING AND THE
IN CONTENTION WITH ONE ANOTHER
AND OTHER NIH INITIATIVES HAVE
USED OPEN AND UNRESTRICTED
ACCESS AND USING PUBLICLY
AVAILABLE DATA OR CONTROLLED OR
TIER ACCESS WHICH REQUIRES A
REQUEST WITH RELEVANT
DOCUMENTATION AND WHILE
INSTITUTIONAL CERTIFICATIONS MAY
ALLOW GRANTEE INSTITUTIONS TO
AFFIRM THAT SUBJECTS HAVE
CONSENTED, TO ALLOW THEIR
GENOMIC DATA TO BE SHARED
THROUGH UNRESTRICTED OR OPEN
ACCESS AND IMPLEMENTATION IS
PRIMARY SEQUENCE DATA IS TO BE
MANAGED THROUGH CONTROLLED
ACCESS AND REGARDLESS OF HOW THE
SUBJECTS HAVE CONSENTED AND THE
NIH OFFICE OF EXTRAMURAL
RESEARCH HAS INDICATED THEY
WOULD CONSIDER A NIH CONVENED
BIOETHICS CONSULTATION AND THEIR
DELIBERATIONS ON THIS MATTER
WHICH IS WHAT WE'RE TALKING
ABOUT HERE.
SO, ON JANUARY THEY, THEY HAD A
CONSULT RELATED TO UNPRESELECTED
TO SEQUENCE DATA AND WE STARTED
THIS CONSULTATION FROM WITH THE
BRAIN STAFF THAT PROVIDED
BACKGROUND MATERIALS WHICH
INCLUDED AN OVERVIEW OF THE
CONSULT REQUEST, GENETIC DATA
SHARING LANGUAGE FROM
PROCUREMENT SITES AND
INSTITUTIONAL CERTIFICATION
FORMS AND INSTITUTIONAL SPECIFIC
CONSENT FORMS AND WE HEARD FROM
EXPERTS THAT Dr. DAVID
PANCHENSO H AND ELLEN CLAYTON AD
WE INVITED THESE FOLKS BOTH TO
GIVE US AN UPDATE ABOUT THESE
DIFFERENT POLICIES AND Dr.
CLAYTON WHO HAS DONE RESEARCH ON
THE ETHNIC OF DATA SHARING WITH
GENOMIC DATA OUGHT TO BE.
THIS SUMMARY PRESENTS WHAT WAS
HEARD FROM THE SPEAKERS AND THE
SUBSEQUENT DISCUSSIONS THAT THEY
HAD AND NOT AWFUL THE POINTS
THAT ARE IN HERE MAY BE SO THE
DISCUSSION QUESTIONS WERE FIRST
WHAT ARE THE POTENTIAL RISKS OF
HAVING UNPREDICTED OR OPEN
VERSUS CONTROLLED OR TIRED DATA
ACCESS TO PRIMARY SEQUENCE DATA
OF LIVING VERSUS DECEASED
PARTICIPANTS AND SOME OF THE
MISUSE CONCERNS NOT OF SHARED
PRIMARY DATA SEQUENCE COULD
INVOLVE FOR EXAMPLE ANY RISK TO
PARTICIPANTS IF LIVING RATHER
THAN POSTMORTEM RECIPIENTS,
POSTMORTEM INDIVIDUALS
PARTICIPANTS FAMILY MEMBERS OF
PARTICIPANTS WHO DIDN'T CONSENT
TO THE RESEARCH BUT OBVIOUSLY
COULD BE EITHER IDENTIFIED OR I
IMPLICATED AS A RESULT OF THE
GENETIC SEQUENCING DATA AND
COMMUNITIES AND SOCIETIES WHERE
THERE'S LITERATURE AND
SCHOLARSHIP AROUND THE
IMPLICATIONS FOR COMMUNITIES AND
SOCIETIES WITH RESPECT TO THE
SHARING OF GENOMIC DATA AND ANY
RISK OF HARM THAT MAY PLOW FROM
REIDENTIFICATION AND THE RISK OF
OPEN DATA SHARING TO THEMSELVES
AND THEIR FAMILY MEMBERS AND
WHETHER IT'S EFFICIENT FOR FULLY
INFORMED CONSENT LOOK LIKE IN
THAT CONTEXT.
NEXT SLIDE, PLEASE.
SO WE DISCUSSED THE POTENTIAL
RISK OF UNRESTRICTED OPEN AND
TIRED DATA ACCESS TO PRIMARY
SEQUENCE DATA OF LIVING AND
DECEASED PATIENTS WOULD BE SO
CONTINUING THAT CONVERSATION
THERE MAY NOT EXIST CLEAR
EVIDENCE OF QUANTIFYING A
DIFFERENT IN RISK BETWEEN OPEN
AND CONTROLLED SHARING THAT IS
THERE'S NOT BEEN ENOUGH RESEARCH
TO REALLY LOOK AT THESE
DIFFERENCES AND WHAT THE
IMPLICATIONS MAY BE.
A DATA ACCESS OR REVIEW
COMMITTEE WOULD BE LIKELY TO
REDUCE THE LIKELY HOOD OF
REIDENTIFICATION OR USES THAT
COULD CAUSE COMMUNITY HARMS AND
COULD LIMIT THE USE TO
SCIENTIFIC PURPOSES AS OPPOSED
TO SOME OF THE MISUSE CONCERNS
FOR LEGAL OR COMMERCIAL OR OTHER
PURPOSES AND CONTROLLED ACCESS
INVOLVED RESEARCH INSTITUTIONS
AND OFTEN TIMES REDUCE THE RISK
OVER ALL AND PARTICULARLY GIVEN
THAT SOME OF THE HARMS THAT WERE
IDENTIFIED WOULD BE FROM EXTRA
RESEARCH INSTITUTIONS NOT FROM
RESEARCH INSTITUTIONS THEMSELVES
AND THEN CONCERNS ABOUT THE
EFFECT OF OPEN SHARING ON
POTENTIAL THEY HAD SHOWN SCIO
DEMOGRAPHIC VARIABLES AND
WILLINGNESS TO PARTICIPATE IN
RESEARCH THAT INVOLVED DATA
SHARING AND COMMUNITY ENGAGEMENT
COULD BE ONE WAY TO MITIGATE
THESE CONCERNS.
OF COURSE, MISUSE OF DATA WOULD
NEGATIVELY IMPACT SO THIS WAS A
CONCERN WE DISCUSSED AS WELL.
NEXT SLIDE, PLEASE.
OF COURSE, NO DISCUSSION ON THE
ETHICS WOULD BE COMPLETE WITHOUT
TRYING TO UNDERSTAND THE RISK
BENEFITS SO WE ALSO WANTED TO
TALK ABOUT THE BENEFITS AND
UNDERSTANDING THE BENEFITS
RELATIVE ANY OF THE RISK THAT WE
HAD IDENTIFIED SO THE QUESTIONS
THAT WE DISCUSSED AROUND WHAT
WERE THE POTENTIAL BENEFITS OF
CONTROLLED VERSUS TIERED DATA
ACCESS AND HOW OPENING SHARING
MORE THAN CONTROLLED SHARING AND
THERE ISN'T EVIDENCE HOW MUCH
MORE THIS IS USEFUL AND HOW MUCH
ADDITIONAL BENEFITS ARISES FROM
OPEN VERSUS CONTROL SHARING.
SECOND WE LOOKED AROUND OPEN
SHARING INVOLVING FEWER
ADMINISTRATIVE BURDENS, TIME AND
COST.
OF COURSE THE DEGREE TO WHICH
IT'S TRUDY PEN DEPENDS ON THE AD
AND SO THAT'S AN EMPIRICAL
QUESTION RATHER THAN A CERTAINTY
AND SOME LAG TIME COULD BE
ACCEPTABLE GIVEN THE OVER ALL
DURATION AND SCIENTIFIC PROJECTS
SO AGAIN IT'S NOT CLEAR HOW MUCH
ADDITIONAL BENEFIT THERE IS AND
HOW MUCH ADDITIONAL BURDEN THERE
IS.
THE PUBLIC ATTITUDES SURVEY
SUGGESTS THAT MOST PEOPLE WHO
ARE WILLING TO SHARE THEIR DATA
SAMPLES WITH CONTROL ACCESS
WOULD ALSO AGREE TO DO SO UNDER
OPEN ACCESS AND SO THIS MAY
REDUCE SOME OF THE CONCERNS THAT
WOULD BE ARISING FROM THE
NEGATIVE EFFECTS OF OPEN SHARING
IF THEY WERE JUST AS LIKELY TO
SHARE IN THAT ON TEXT AND HE
WILAS WELL ANDTHIS WOULD SHARE D
AUTONOMY OF THE PARTICIPANTS.
NEXT SLIDE, PLEASE.
SO CONTINUING THIS DISCUSSION,
WE LOOK AT GIVEN SOCIETAL TRENDS
AND OUTSIDE OF NIH SUPPORTED
RESEARCH SOME OF THE PEOPLE IN
THE DISCUSSION QUESTION THE
DEGREE TO WHICH NIH SHOULD
PROTECT PARTICIPANTS' PRIVACY
AND BY CONTRAST PERSONAL DATA IS
BEING MISUSED, THIS COULD
INCREASE NIH'S DUTY PROTECT
PERSONAL DATA.
IT ISN'T TO SAY IT NEVER HAPPENS
BUT THERE ARE NOT A LOT OF WELL
DESCRIBED MANY ABUSE CASES OF
USING DATA INVOLVED IN RESEARCH
SETTINGS AND THERE'S A LINE WITH
FUNDAMENTAL PRINCIPLE OF
SHIFTING TOWARDS OPEN SCIENCE
RELATIVE TO CONTROLLED ACCESS.
SO THIRD, WE THEN LOOKED AT WHAT
STRATEGIES MIGHT MINIMIZE RISK
SO ASSUMING THAT WE THINK
THERE'S STILL SOME RISK THAT
WOULD ARISE FROM AN OPEN ACCESS
APPROACH VERSUS THE CONTROLLED
TIRED ACTS WHAT ARE THE WAYS WE
CAN MITIGATE AGAINST THOSE RISKS
AND WE DISCUSSED IN PARTICULAR
NOT TWO MAJOR APPROACHES TO
DOING SO ONE WOULD BE IMPROVING
AND INFORMED CONCEPT SO THIS
WOULD BE UPDATING CONSENT FORMS
AND THAT CAN CLARIFY THE RISK OF
OPEN SHARING AND PROTECTION AND
THE RISK OF REIDENTIFICATION
PARTICULARLY GIVEN AGENCY AND
AUTONOMY OF INDIVIDUALS GIVING
FULLY INFORMED CONSENT WOULD
MEAN MAKING SURE THE LANGUAGE IS
WRITTEN AROUND AN EIGHTH GRADE
READING LEVEL AND THE
SUFFICIENCY OF INFORMED CONSENT
EVEN IMPROVED REMAINS UNCLEAR
BECAUSE MANY TIMES THESE ARE
TREATED AS PROFORMA FORMS FOR
PEOPLE TO FILL OUT RATHER THAN
KIND OF CAREFULLY READING AS
IT'S UNCLEAR THE EXTEND IT WOULD
DISCHARGE THE DUTY BUT IT WOULD
AT LEAST ENSURE THAT PEOPLE WERE
RECEIVING THE INFORMATION IF
THEY CHOSE TO DIE INTO IT AND
SECOND IS REQUIRING OPEN ACCESS
ONE WAY TO ADDRESS THIS WOULD
EMBED BIO ETH SIS IN BUY CAM
PROJECTS TO ASSIST
CONSIDERATIONS OF THESE
CHALLENGES TO FLUSH OUT CONSENT
FORMS AND TO THINK CAREFULLY
ABOUT THE RISK AND BENEFITS IN A
CONTEXT SPECIFIC WAY THAT'S IT.
YOU CAN LEARN MORE AT THIS LINK.
AND IS GRATEFUL ACKNOWLEDGMENTS
TO MY CO-CHAIRS.
WHO HELPED TO FACILITATE THE
CONSULTATION AS WELL AS TO
PREPARE THE BACKGROUND MATERIALS
AND THESE PRESENTATIONS AND
CONSULT REQUESTERS, Dr. JOHN
NYE, Dr. NCCIH MER, Dr.
Dr. YOUNG YAW AND THE SPEAKERS
WHO JOINED THAT DAY.
THAT'S JUST A LITTLE BIT OF
BACKGROUND.
WE HAVE A FEW MINUTES FOR
QUESTIONS AND I KNOW ANDREA IS
HERE TO ANSWER ADDITIONAL
QUESTIONS IF I AM UNABLE TO STAY
WITH YOU FOR MORE QUESTIONS.
>> Joshua Gordon: THANK YOU SO
MUCH.
ARE THERE QUESTIONS OR COMMENTS
FROM MEMBERS OF THE COUNCIL?
Dr. COLLINS.
>>THANK YOU FOR THE
PRESENTATION.
VERY T I JUST HAVE A QUESTION,
IS THERE A PORTFOLIO THAT IS
PART OF THE BRAIN INITIATIVES
THAT ACTUALLY STUDIES SOME OF
THESE ETHICS QUESTIONS AND CAN
GET PERSPECTIVES FROM
PARTICIPANTS?
>>THERE IS.
Dr. FARAMAMY OR DO YOU WANT TO
COMMENT HOW CLOSE THREE MIGHT
MATCH THESE ISSUES?
KHYAN LEGAL ANDREA JUMP IN ON
THAT TO SAY THERE'S BEEN A
NUMBER OF RFAs THAT ARE
RELATED TO NEUROETHICS AND
DIFFERENT FOLKS STUDYING
DIFFERENT ASPECTS THAT ARE BOTH
RELATED TO INFORMS CONSENT AND
RISK OF HARMS THAT ARISE FROM
USE OF SHARING OF DATA BUT
ANDREA MAY BE ABLE TO BETTER
ADDRESS THE PARTICULAR NOT
FUNDED RESEARCHERS ARE STUDYING
THIS ISSUE IN PARTICULAR.
>>YOU ANSWERED HE QUESTION.
WE DON'T HAVE SPECIFIC GRANTS
FUNDED FOR THIS IT STRUCK ME
THAT THOSE WHO CURRENTLY WANT TO
SHARE ARE FINE WITH CONTROLLED
ACCESS VERSUS OPEN ACCESS.
BUT I WONDER ABOUT THOSE WHO WE
ARE, WE TALKED ABOUT POPULATIONS
AND WE'RE TRYING TO ENCOURAGE TO
COME THESE THOSE STUDIES AND
WHETHER OR NOT THERE'S GOING TO
BE SOME WORK TO EXAMINE IF THERE
ARE DIFFERENCES WITH THOSE
POPULATIONS IN TERMS OF NOT WHAT
THEIR PREFERENCES ARE FOR
CONTROL VERSUS OPEN ACCESS AND
I'M ALSO WONDERING IF THERE'S A
HYPE OF POSSIBILITY THAT IS
OPTION THAT IS POSSIBLE.
>>
>>PLEASE, GO AHEAD.
>>YOU ARE SHORT ON TIME.
>>I WAS JUST GOING TO SAY, IT'S
INTERESTING BECAUSE THERE'S BEEN
A GOOD BIT OF RESEARCH YOU DONE
ON WILLINGNESS TO SHARE WITH
RESEARCHERS ACROSS DIFFERENT
COMMUNITIES AND THE NUMBERS STAY
PRETTY CONSTANT ACROSS DIFFERENT
COMMUNITIES AND AND OF THOSE
COMMUNITIES WHO ARE GENERALLY
INVOLVED YOU ARE LOOKING AT A
PRETTY CONSISTENT WILLINGNESS TO
SHARE AND IT BREAKS DOWN TO
USUALLY 80/20 AND DEPENDING ON
WHETHER IT'S AN OPT-IN OR
OPT-OUT APPROACH.
ONE OF THE PRESENTATIONS WE HAVE
FROM Dr. CLAYTON SHOWED THERE
WAS A SIGNIFICANT WILLINGNESS BY
PEOPLE TO SHARE THE CONTEXT
ALONG AS THEY WERE ADEQUATELY
GIVEN INFORMATION ABOUT THE RISK
AND BENEFITS OF DOING SO.
>>WE ACTUALLY DO HAVE SOME
STUDIES THAT ARE ON THAT TOPIC
SPECIFICALLY THAT WE'RE
SUPPORTING AND WE DON'T HAVE
DATA YET BUT WE HOPE TO HAVE IT
SOON AND I THINK SOME OF OUR
FOCUS HAS BEEN ON ENGAGEMENT AND
PROMOTING UNDERSTANDING.
>>TED --
>>A COMMENT.
THANK YOU FOR THE PRESENTATION.
AND I WANTED TO RELAY ONE THING
THAT JOHN NYE PUT IN THE WEBINAR
CHAT THAT THERE ARE BIO EMPHASIS
EMBEDDED IN THE BUY CAM PROJECTS
AND IT'S WHAT I WANTED TO POINT
OUT THAT IS A TERRIFIC MODEL AND
THE IDEA OF HAVING BIO ETH A SIS
AS PART OF OUR LARGER PROJECTS
IS SOMETHING THAT I FIRST
ENCOUNTERED WITH THE BRAIN
INITIATIVE AN I'M THE
REPRESENTATIVE OF THIS COUNCIL
ON THE MULTI COUNCIL WORKING
GROUP AND I THINK IT'S A
TREMENDOUS IDEA AND I THINK THAT
THAT IS TO ME ONE OF THE MOST
PORT AM THINGS TO THINK ABOUT AS
A RESPONSE TO THIS AND WE MAY
WANT TO THINK ABOUT IT MORE
BROADLY AS WE THINK ABOUT OUR
LARGER CENTER INITIATIVES
BECAUSE I THINK THAT THE BIO ETH
SIS HAVE A LOT TO TEACH US AND
THE VERY NITTY GRITTY DISCUSSION
I HAD WAS ABOUT THE DIFFERENCE
OF HAVING A BRAIN SAMPLE AND
WHETHER YOU ARE GOING TO DO
SINGLE NUCLEAR RNA SEEK OR MULTI
OMIC WHERE YOU SEQUENCE THE
WHOLE GENOME.
YOU HAVE AN IRB AND YOU CAN HAVE
A SYMBOL BUT DON'T SEQUENCE MY
GENOME.
IT COMES IN UP BRAIN INITIATIVE
WHERE OPPORTUNITIES IS THE MORE
AND MORE PATIENTS THAT ARE IN
NEURO SURGICAL STUDIES AND BRAIN
COMPUTER INTERFACE STUDIES AND
HOW THOSE WORK WHICH IS ONE AREA
WHERE THEY'RE HEAVY INVOLVED
WHICH IS TREMENDOUSLY IMPORTANT
SO I THINK ONE THING FOR US TO
THINK ABOUT AT NIMH IS
INCORPORATING NOT NEUROETHICS IN
WHAT WE DO AND WHAT WE THINK
ABOUT MORE.
THANK YOU.
>>I'M GOING TO SAY HEAR HEAR TO
THAT ONE.
I WILL SAY THAT WHAT YOU SAID IS
IMPORTANT AND JOHN'S POINT HERE
ABOUT EMBEDDING IS THE IMPORTANT
WHICH IS, THE MORE IT'S PART OF
AN ONGOING DIALOGUE, THE MORE
THERE'S A ROLE AND MITIGATESSED
RIT'S MOREREACTIVE AND AFTER THR
IT'S HARDER TO HAVE AN
INTEGRATED AND THE PROGRESS OF
THE STUDY ITSELF ORS WHERE
PEOPLE ARE OFF ON AN ISLAND
DOING THEIR OWN THING RATHER
THAN INTEGRATING IT INTO THE
RESEARCH PROCESS ITSELF.
>>THANK YOU, VERY MUCH.
APPRECIATE IT.
AND HOPEFULLY JOHN AND ANDREA
YOU GOT ENOUGH TO THINK ABOUT OF
HOW YOU WILL MOVE FORWARD AND
WITH THAT WE'LL MOVE INTO THE
NEXT SEGMENT OF OUR MEETING
WHICH IS THE PUBLIC COMMENT
SECTION.
VERY PLEASED TO RETHE PUBLIC AND
I BELIEVE WE HAVE ONE PRIOR
REGISTRANT WHO WOULD LIKE TO
GIVE ORAL COMMENT.
RESTRICT YOUR COMMENTS TO THREE
MINUTES WHICH I WILL TIME TO
MAKE SURE THAT WE STICK TO IT
AND SO I INVITE FIRST THE PRIOR
REGISTRANT TO COME AND THIS IS
Dr. OKACHNGA AND THE PEOPLE OF
ETHICAL TREATMENT OF ANIMALS AND
I BELIEVE WE HAVE A MICROPHONE
SET UP FOR YOU.
>>
>>GOOD AFTERNOON, ALL.
MY NAME IS Dr. AKLCANA AND I
SERVE AS PRICE HAVE OF THE PITA
LABORATORY AND CASES AND THE
TREATMENT OF ANIMALS AND CARRIED
AT THE INTRAMURAL RESEARCH
PROGRAM AND IN THE LAB, MACAQUES
ARE SUBJECTED TO NUMEROUS AND
INVASIVE SURGERIES TO HAVE
TOXINS INJECTED INTO THEIR
BRAINS AND HEAD POSTS AND
CHAMBERS SCREWED TO THEIR
SKULLS.
THESE MONKEYS ARE RESTRAINED FOR
HOURS AT A TIME DEPRIVED OF FOOD
AND WATER SO THEY WILL COOPERATE
WHEN SUBJECTED TO BEHAVIORAL
TRIALS AND OFTEN FOR THEM IS
SOCIAL ISOLATION FOR YEARS
BEFORE BEING KILLED.
THESE EXPERIMENTS WHICH HAVE
BEEN GOING ON FOR FOUR DECADES,
AND HAVE COST TAXPAYERS
$50 MILLION, HAVE FAILED TO
PROVIDE DATA MEANINGFUL ENOUGH
TO IMPROVE HUMAN MENTAL HEALTH.
AS A CONSIDERABLE HARM INFLICTED
ON NON CONSENTING SEN TEE ANT
MONKEYS ARE EVIDENCE IN
DOCUMENTS MAINTAINED BY A LAB
WHICH WERE OBTAINED OF PETA
THROUGH FREEDOM OF INFORMATION
REQUEST.
I'LL SHARE THE STORY OF JUST ONE
MONKEY.
SAM SMITH, AS LAB STAFF NAMED
HIM WAS BORN AT A SOUTH CAROLINA
BASED MONKEY BREEDER AND DEALER
CALLED ALPHA GENESIS.
AND BROUGHT TO NIH WHEN HE WAS
TWO.
HE WAS NEARLY FIVE WHEN HE WAS
PLACED IN THE INTRAMURAL LAB AT
A NIMH.
SHORTLY THERE A. EXPERIMENTERS
CUT INTO SAM'S SKULL AND
INJECTED EXCITE OWE TOXINS INTO
HIS MIG DA LA CAUSING PERMANENT
BRAIN DAMAGE.
TWO WEEKS LATER HE WAS SUBJECTED
TO ANOTHER SURGERY THIS ONE TO
REMOVE A HEMATOMA FROM UNDER HIS
SKULL AFTER A BLOOD VESSEL WAS
CUT DURING THE PREVIOUS SURGERY.
A FEW WEEKS AFTER THAT.
SAM SMITH'S CORTEX WAS LESIONED
THROUGH ASPIRATION.
SAM SMITH HAS BEEN CAGED ALONE
SINCE JULY OF 2009.
NOTATIONS AND SAM SMITH'S
RECORDS INDICATE THAT HE ENGAGES
IN STEREO TYPING AND CIRCLING IN
HIS CAGE AND ROCKING BACK AND
FOURTH, HIS PSYCHOLOGICAL
DISTRESS IS EVIDENT IN HIS
EXTENSIVE HAIR LOSS.
UNABLE TO CONTROL ANYTHING IN
THEIR LIVES, MONKEYS IN LABS
PULL OUT THEIR OWN HAIR.
IT'S ONE THING THEY CAN CONTROL.
SAM SMITH HAS BEFORE STARVED,
SEDATED, STRAPPED INTO
RESTRAINTS AND FORCED TO ENDURE
PAINFUL PROCEDURES.
HE IS JUST ONE OF HUNDREDS OF
MONKEYS WHO HAVE BEEN HARMED IN
THIS INTRAMURAL LAB.
TO OUR KNOWLEDGE, SAM SMITH IS
STILL ALIVE.
AND IS ONE OF 91 RECESS MACAQUES
CURRENTLY HELD IN THIS LAB.
IS THAT THREE MINUTES?
WELL, I BELIEVE THE FULL
TRANSCRIPT OF MY COMMENTS ARE IN
YOUR RECORDS.
THANK YOU, VERY MUCH.
>>THAT'S RIGHT.
THANK YOU.
FULL COMMENTS ARE IN THE
RECORDS.
THANK YOU, VERY MUCH.
>> Joshua Gordon: ALL MEMBERS
OF OUR COUNCIL HAVE RECEIVED
THEM.
APPRECIATE YOU COMING TO US
TODAY.
ARE THERE OTHER MEMBERS OF
PUBLIC MEMBERS WHO WOULD LIKE TO
MAKE A COMMENT?
-THANK YOU.
ARE THERE ANY QUESTIONS OR
COMMENTS FROM THE COUNCIL?
ALL RIGHT.
WELL, WITH NO FURTHER ADIEU, I
THINK WE ACTUALLY ADJOURN ON
TIME.
APPRECIATE EVERYONE'S WORK TODAY
AND I ESPECIALLY APPRECIATE THE
WORK THAT WE WILL DO TOMORROW
DURING THE CLOSED SESSION AND
WITH THAT, I CONCLUDE THE OPEN
SESSION OF THIS COUNCIL.
I GET TO BIND THE GAVEL.