Genomics and Society: The ELSI Research Program and Beyond – Karen Rothenberg


>>SO WE’RE GOING OUT OF
ORDER ON THE AX GENDA AT VARIOUS TIMES.
WE HAVE A PRESENTATION NOW BY KAREN ROTHEN BURG.
KAREN IS A MEMBER OF THE FACULTY OF THE UNIVERSITY OF
MARYLAND LAW SCHOOL. BEEN ASSOCIATE INDEED VARIOUS
WAYS WITH OUR ELSI PROGRAM FOR MANY YEARS AND I ASKED
KAREN TO DO A SEBATICLE FOR A YEAR STARTING LAST YEAR.
AND NHGRI AS A SPECIAL ADVISOR TO ME.
AND PARTICULARLY THERE WERE A NUMBER OF CIRCUMSTANCES I
THOUGHT I COULD USE SOMEONE OF HER EXPERTISE TO COME IN
AND HELP LOOK AT THINGS, MAKE RECOMMEND ANTICIPATIONS FOR
ME, VANSLY WE HAVE THE NEW STRATEGIC PLAN WHERE WE
DESCRIBE OUR INTERESTS IN GENOMICS AND SOCIETY AS WE
DESCRIBED IT AND WHICH WOULD CERTAINLY ENCLUED THE CLASSIC
RESEARCH PROGRAM BUT THIS COMES FOLLOWING LOTS OF
DISCUSSION ABOUT OUR ELSI RESEARCH PROGRAM OVER THE
YEARS AND LOTS OF INTEREST IN SEE TGF CONTINUE TO THRIVE IN
THE IF THURE. SOY KAREN HAS ASKED HER TO
LOOKITY HORRICALLY AND IN THE FUTURE AND GIVE ME
RECOMMENDATIONS WHERE WE IMPLEMENT ORIGINAL STRATEGIC
PLAN IN THAT AREA AND SHE WILL GIVE YOU AN UPDATE ON
WHAT SHE’S BEEN DOING AND HER THINKING ALONG THOSE LINES.
THANK YOU. I JUST WANTED TO FIRST START
BY EXPRESSING SOMETHING EVERYBODY AS COUNCIL KNOWS
BUT JUST THE INCREDIBLE GOOD WILL OF THE PEOPLE THAT WORK
AT NHGRI AND HOW HELPFUL THEY’VE BEEN IN ALLOWING ME
THE TIME OF INTERVIEWS AND LOOKING AT DATA AND HELPING
WITH THE ASSESSMENTS AND GETTING WHAT I NEED.
I COULD BE A LITTLE UNRELENTING SOMETIMES SO I
JUST WANT TO EXPRESS MY APPRECIATION.
SHE’S SMILES BUT THERE BUT PARTICULARLY TO JOY.
JOY AND JEAN AND ELIZABETH. AND ALSO TO CHRIS.
WHO IF ANYTHING LOOKS SNAZZY AT ALL IN TERMS OF A PICTURE,
I THANK CHRIS FOR THAT, SO THANK YOU.
I ALSO WANTED TO EXPRESS MY THANKS TO THE EXTRAMURAL
GRANTEES, PARTICULARLY THOSE THAT ARE IN THE SEER, BUT
ALSO ALL OVER THE COUNTRY. I’VE HAD A NUMBER OF
INTERVIEWS, PRESENTATIONS, CONVERSATIONS, ASK THEM TO
FILL OUT QUESTIONNAIRES AND EVERYBODY WITHOUT EXCEPTION
HAS BEEN JUST WONDERFUL SO I WANT TO START WITH THAT.
YOU DON’T??YOU DON’T KNOW FOR SURE IF YOU’VE GOTTEN
EVERYBODY BUT IF FOLLOWING THIS, ANYBODY HAS ANY FURTHER
COMMENTS TO PLEASE PASS ON AND I WILL INTEGRATE THEM AS
BEST AS I CAN. SO JUST FOR BACKGROUND I
NOTICED ON THE TABLE, I SEE DIFFERENT LEVELS OF AGE AND
MATURITY, SO I WENT BACK TO 1990, JUST GO A LITTLE BIT IN
PERSPECTIVE. THAT THE ELSI RESEARCH
PROGRAM WAS ESTABLISHED A LITTLE BIT MORE THAN 20 YEARS
AGO AND THIS WAS THE SPECIFIC MISSION TO ANTICIPATE AND
ADDRESS THE ETHICAL LEGAL AND SOCIAL IMPLICATIONS OF
GENETIC AND GENOMIC RESEARCH. IT WAS UNPRECEDENTED AND I
WANT TO EMPHASIZE IT, UNPRECEDENTED TO HAVE A
SPECIFIC SET ASIDE THAT STARTED AT 3% AND THEN BECAME
BY SENATOR HARKIN, WITHIN THE YEAR OR 2 OF THE
ESTABLISHMENT OF THIS PROGRAM, 5% SET ASIDE OF THE
EXTRAMURAL RESEARCH BUDGET. AND SO WHAT SOME WOULD SAY OR
THIS WAS SOMEWHAT OF A SCIENCE POLICY EXPERIMENT TO
ACTUALLY EMBED AND INTEGRATE THINKING DEEPLY ABOUT ETHICAL
AND SOCIAL IMPLICATIONS OF SCIENCE.
HOW THIS TRANSLATES THAT IN THE LAST FISCAL YEAR, A
LITTLE OVER 19 MILLION DOLLARS OR ALMOST 280 MILLION
DOLLAR OVER THE LAST 21 YEARS HAS BEEN SPENT ON THIS
PORTFOLIO. AND WE ARE THE ENVY OF THE
WORLD, THERE HAVE BEEN A FEW OTHER COUNTRIES, I HAVE BEEN
DOING SOME RESEARCH ON WHAT’S BEEN GOING ON AROUND THE
WORLD AND HOW THEY FUND ELSI OR GENOMICS OR SOCIETY,
EVERYBODY HAS A DIFFERENT NAME BUT WE ARE THE LARGEST
FUNDER OF “BIOETHICS RESEARCH” IN THE WORLD.
I MIGHT ALSO SAY WE HAVE ESTABLISHED QUITE A LEGACY OF
THOUSANDS OF PUBLICATIONS THAT HAVE NOW MADE IT COMMON
PLACE TO DO INTERDISCIPLINARY WORK AND HAVE IT PUBLISHED
COLLABORATIVELY. I WANTED TO JUST START BY
SORT OF SETTING A TONE. BECAUSE I THINK WE MAY TAKE
FOR GRANTED THAT WE HAVE EMBEDDED ELSI RESEARCH
PROGRAM AT NHGRI, BUT IT IS IN FACT, IT DOES INFACT POSE
SOME INHERENT CHALLENGES THAT I THINK WE’LL SEE AS I GO
THROUGH THIS. FIRST OF ALL JUST BY
DEFINITION, THERE’S A CLASS OF CULTURE.
PEOPLE THAT CHOOSE TO BE SCIENTISTS AND PEOPLE THAT
CHOOSE GO INTO LAW OR BIOETHICS OR MAYBE EVEN SOME
OTHER FORMS OF SOCIAL SCIENCE.
THERE MAY BE DIFFERENT CLASSES OF CULTURES, HOW WE
COMMUNICATE WITH 1 ANOTHER. RESEARCH TOOLS WE USE AND
SOMETIMES THIS CREATES SOME INTERDISCIPLINARY MYSTERY.
SOMETIMES I WOULD SAY INCREASINGLY IT HAS CREATED
MORE TRUST. DID YOU ABOUT BECOMES AN
EVOLUTION OVER TIME. IT ALSO IS IMPORTANT THAT WE
CLARIFY OUR GOALS AND OUR ROLES BECAUSE IN DIFFERENT
COUNTRIES, THAT HAVE SIMILAR SOURCE OF PROGRAMS, THEY HAVE
DIFFERENT MISSIONS. SO IS OUR MISSION TO
OBJECTIVELY ASK QUESTIONS ABOUT ANTICIPATING WHAT THESE
IMPLICATIONS ARE? OR AS IN SOME OTHER COUNTRIES
WHERE WE ACTUALLY ARE HERE TO HELP WORK WITH SOCIETY TO
PROMOTE ENHANCING GENOMICS AND GENOMICS RESEARCH.
AND DEPENDING WHAT OUR GOALS OR ROLES ARE, THEY CAN BE BE
BOTH IT MAY HAVE AN IMPACT ON HOW WE LOOK AT HOW WE ASSESS
THE PROGRAM. THE NEXT 2 OR 3 ARE INHERENT
TO THIS APPROACH IN THE FIELD.
IT’S ANTICIPATING WHAT THE FUTURE WILL BRING US IN
LOOKING AT WHOLE GENOME SEEQUENCING AND FIGURE OUT
WHERE WE’RE GOING WITH IF, SCIENTIFICALLY, AS AN
INTERESTING QUESTION. THAT BOTTLE NECK THIS ERIC
ALWAYS TALKS ABOUT ARE INTERESTING BUT IT’S ALSO
VERY HARD TO ANTICIPATE HOW IT’S GOING TO MAKE ITS WAY
INTO SOCIETY AND HOW DEEPLY IT’S GOING TO MAKE ITS WAY.
AND THAT GETS ME TO THIS NEXT POINT ABOUT RESEARCHING
SOCIETY. WE LEARN FROM PAST EXPERIENCE
THAT IT’S HARD TO KNOW THE TYPE OF BENEFIT, QUESTIONING
THE PUBLIC IS HYPOTHETICAL, WHAT THEIR PREFERENCES ARE,
WHETHER THEY’RE GOING TO GO AND GET A TEST OR NOT, PLAY
OUT WHEN THAT TEST BECOMES AVAILABLE.
SO HOW DO YOU GO BA RESEARCHING SOCIETY?
WHO IS THE SOCIETY? HOW DIVERSE DO YOU NEED THE
SOCIETY TO BE AND WHAT KINDS OF TOOLS CAN WE REALLY
MEASURE. OH I’M SORRY.
NEXT IS THE CONCEPT OF GENETIC EXCEPTIONALISM.
SO WHEN THE DECISION WAS MADE TO PUT THIS??SET ASIDE IN
STUDYING THE ETHICAL, LEGAL AND SOCIAL IMPLICATIONS OF
GENETICS AND GENOMICS RESEARCH AND WHAT THEY MIGHT
MEAN TO US, WHAT IMPACT DID THAT HAVE AND HOW IN FACT DID
IT PLAY OUT VIS?A?VIS ALL THE OTHER BIOETHICAL ISSUES FOR
EXAMPLE THAT JUST ARE NOT UNIQUE TO GENETICS.
WE SAW THIS CONVERSATION PLAY ITSELF OUT WHEN THE GENOME
WAS PASSED AND WE WERE FOCUSING ON GENETIC
NONDISCRIMINATION AND PRIVACY, THIS A GOOD THING?
IS IT A BAD THING? IT’S NEITHER.
IT MAY JUST BE VERY CONTEXTURAL.
ARE THERE AREAS WHERE WE REALLY DO NEED TO DRILL DOWN
DEEPLY BECAUSE IT’S A ABOUT GENETICS AND GENOMICS.
AND WHEN DO WE AND WHEN DON’T WE AND THAT BECOMES AN
INTERESTING CHALLENGE FOR US AND FINALLY THE FINAL
CHALLENGE WHICH IS MINE AS WELL AS ALL OF YOURS AND HOW
THAT IS HOW DO WE MEASURE THE IMPACT?
HOW DO WE KNOW THAT THE ELSI RESEARCH HAS MADE A
DIFFERENCE? ALL I CAN SAY IS THAT IT IS A
VIBRANT DISPELLED AT THAT POINT, I’M GOING THROUGH MORE
AND MORE, SOME OF THE ASSESSMENT TOOLS WE USE AND
WE LOOKED AT BUT IN FACT WE HAVE A A THRIVING, IN THIS
COUNTRY, THRIVING DEVELOPMENT OF GENETICS AND GENOMICS
RESEARCH AND I DON’T THINK IT’S COINCIDENTAL THAT WE
ALSO HAVE A THRIVING ELSI RESEARCH PORTFOLIO.
SO I WANTED TO JUST LIST FOR YOU??OKAY.
DOES SOMETHING STRIKE YOU JUST BY THIS LIST?
THERE’S AN AWFUL LOT OF ASSESSMENT GOING ON ABOUT THE
ELSI RESEARCH PROGRAM. I MEAN EVERY FEW YEARS
THERE’S ANOTHER ASSESSMENT GOING ON ABOUT THE ELSI
RESEARCH PROGRAM. AND I THINK IT MIGHT SOMEWHAT
BE TIED TO SOME OF THOSE INHERENT CHALLENGES.
AND IN EACH OF THESE ASSESSMENTS, THERE WERE IN
FACT SOME COMMON PERCEIVED THAT CONTINUED TO BE
DESCRIBE??PERCEIVED TENSIONS THAT CONTINUE TO BE DESCRIBED
AND I AM AN OPTIMISTIC PERSON DON’T ACTUALLY SEE THESE AS
TENSIONS BUT I SEE THESE AS OPPORTUNITIES AND CHALLENGES
THAT IN FACT, IT’S NOT AN EITHER OR.
THAT IN FACT, THE ELSI RESEARCH PORTFOLIO AND THE
FUTURE CAN IN FACT REACH A WAY TO ACTUALLY MODULATE WHAT
THESE TENSIONS ARE. BUT I MIGHT ALSO SAY THEY’RE
NOT REALLY UNIQUE TO JUST THIS RESEARCH PORTFOLIO.
THEY RAISE IN FACT A LOT OF QUESTIONS AS YOU THINK ABOUT
HOW BEST TO CREATE AND PROMOTE A GRANTS PROGRAM.
SO THE FIRST IS WHAT I WOULD CALL INTERNATIONAL
CLASSIFICATION AND OBJECTIVITY.
ON THE 1 HAND YOU WANT TO HAVE AN ELSI PROGRAM THAT
ALLOWS PEOPLE TO BE OBJECTIVE IN THEIR WORK INCLUDING BEING
CRITICAL OF SOME OF THE FRIENDS THAT SAY AS A
SCIENTIST MOVING AWAY ALONG IN THE CONCEPT OF SOCIETY.
A LOT OF IS CONGENICS AND MODIFICATION AS WE MOVE TO
NEW GENETICS. ON THE OTHER HAND 1 OF THE
MOST EXCITING THINGS I SEE HAPPENING AS A SCIENCE HAS
EVOLVED AND AS THERE HAS BEEN INCREASING TRUST IN THE
INTERDISCIPLINARY WORK IS INTEGRATION ON SOMETHING THAT
HAS REALLY BEEN FOSTERED BY THE PROGRAM DIRECTORS IN THE
ELSI RESEARCH PROGRAM TOGETHER WITH THE WHOLE
EXTRAMURAL STAFF HERE. THAT AS WE HAVE MOVED FROM
ORGANISMS TO HUMANS THERE HAS INCREASINGLY BEEN THE
INTEGRATION FROM THE VERY BEGINNING BRINGING IN THE
ELSI FOLKS TO WHAT ARE THE ISSUES WE TEDE TO ASK AND
STUDY FROM STEP 1. THAT IS NOT SOMETHING TO TAKE
FOR GRANTED AND IT IS THE ENVY OF THE OTHER INSTITUTES
ON SO MANY LEVELS. SO HOW DO WE DO THAT AND FEEL
YOU CAN SPEAK UP WHEN YOU’RE A RESEARCHER SOME SOMETHING
IS CONCERNED TO YOU. SECONDLY BASIC RESEARCH AND
TRANSLATION. AGAIN THIS IS NOT UNIQUE TO
THE ELSI RESEARCH PROGRAM BUT THERE IS SOME VALUE IN
SCIENCE TO JUST DOING BASIC RESEARCH AND THAT’S TRUE
HERE, TOO. THERE ARE BASIC NORMAATIVE
QUESTIONS THAT CAN ASKED THAT ARE NORMAATIVE QUESTIONS AND
THEY ULTIMATELY IMPACT ON TRANSLATION BUT THEY MAY NOT.
BUT WHEN DO WE KNOW AND WHEN CAN WE JUST SAY TO THE
PHILOSOPHER OR THE LAWYERS, THERE MAY BE BASIC RESEARCH
QUESTIONS WE CAN ASK AND WE WILL SEE HOW THAT PLAYS OUT.
THE INVESTIGATOR INITIATED VERSES PROGRAM INITIATED.
AGAIN NOT UNIQUE TO ELSI, BUT NHGRI HAS HAD A TRADITION OF
HAVING MOST OF THE EXTRAMURAL DOLLARS BE TARGETED AND
THERE’S A SMALL INITIATED BUDGET IN THE EXTRAMURAL
PROGRAM EXCEPT FOR ELSI. AND THAT’S EYE BY THE NATURE
OF THE SCIENCE, YOU HAD A LOT OF SCALING UP AND YOU STILL
DO, HAVE LARGE SEQUENCES, CENTERS FOR EXCELLENCE AND
THE ELSI RESEARCH PROGRAM IN THE LAST 20?21 YEARS AT ITS
LOWEST LEVEL HAS BEEN 50/50. 50% INVESTOR INITIATED AND
50% RFA AND IT GOES UP AND DOWN OVER THE LAST 20 YEARS,
RIGHT NOW IT’S JUST AT ABOUT 50.
WHAT IS THE RIGHT PERCENTAGE. SOMETIMES THE INVESTIGATOR
INITIATED HAS BEEN AS HIGH AS 70.
BUT RIGHT NOW IT’S JUST ABOUT 50 AND AS YOU INTEGRATE MORE
AND MORE ELSI RESEARCH INTO THE STUDY, AND THOSE ARE RFAs
YOU WILL SEE THAT PERCENTAGE SLIGHTLY SHIFT.
BY EDTH AND DEPTH, I MEAN DIVERSITY OF DISCIPLINE,
DIVERSITY OF METHODOLOGIES, DIVERSITY OF PEOPLE AND WHAT
SORT OF BALANCE WE CAN APPROACH THERE IS THE DEPTH
ARE BOTH REALLY IMPORTANT WHEN YOU’RE DEALING WITH ELSI
ISSUES AND THEN OF COURSE, THE CONSULTATIVE AND RESEARCH
TENSION THAT ALL OF YOU SITTING AROUND THE ROOM DEAL
WITH ON A DAILY BASIS, BUT THIS IS ALSO BEEN A MAJOR, I
THINK BOTH EXCITEMENT AND FRUSTRATION FOR THE ELSI
PROGRAM, BECAUSE SO MUCH WHAT THEY’RE BEING ASKED AS WE
MOVE INCREASINGLY TO HAVING HUMANS IN OUR RESEARCH IS A
CONSULTATIVE FUNCTION. SO WHAT I WANT TO TAKE YOU
THROUGH NOW IS THE EVOLVING FUNDING APPROACHES OVER THE
LAST 20 YEARS. SO IN VARY MUCH IN THE
BEGINNING. BEGINNING OF THE PROGRAM
THERE WERE NO RFAs INITIALLY, THERE WAS A PROGRAM
ANNOUNCEMENT AND IT WAS VERY BROAD, THE FOCUS WAS THE
CLOSEST AND CONCERN HAD A LOT TO DO WITH PRIVACY AND
DISCRIMINATION. WE WEREN’T DEALING WITH
HUMANS AT THAT POINT, WE WERE DEALING WITH??I DON’T KNOW
WHAT YOU WERE DEALING WITH. MODELS AND LITTLE ORGANISMS
AND ALL THAT STUFF. YEAH, WORMS, WHATEVER.
SO, BUT, SOON AFTER THAT, THE OTHER INSTITUTES TOGETHER
WITH I BEING FRANCE SISS’ VISION AT THE TIME??TOGETHER
WITH, I THINK FRANCIS’ VISION AT THE TIME WERE LOOKING AT
THE EVOLVING GENETIC TESTS FOR CYSTIC FIBROSIS AND WE’RE
SEEING EVOLVING THE BEGINNING OF GENETIC TASKS FOR CANCER.
HOW ARE WE GOING TO STUDY THEM AND HOW ARE WE GUESSING
TO KNOW WHAT THESE ARE AS WE INTEGRATE THESE INTO CLINICAL
CARE? AND THE STAFF INITIATED
LEGACY HERE WITH THESE CONSORTIUMS IN WHICH I HAD
THE PLEASURE TO BE INVOLVE WIDE THE CANCER GENETICS
CONSORTIUM TO BRING TOGETHER PEOPLE FROM DIFFERENT
DISCIPLINES WORKING ON SOME OF THE PSYCHOSOCIAL
NORMAATIVE AND CLINICAL INTEGRATION CHALLENGES OF OF
STARTING TO DO CERTAIN TESTS, TARGETED TESTS FOR CERTAIN
DISEASES AND WHAT WAS REALLY INTERESTING ABOUT THIS AND I
WANT TO JUST SHARE THIS INSIGHT I DON’T THINK THIS
WAS THE FIRST TIME BUT WHAT IT DID WAS WE WERE GOING TO
STUDY THIS IN RESEARCH CONTEXT SO WE WERE STUDYING
THIS IN ACADEMIC INSTITUTION AND WE WERE IN PART HELPING
TO PAY FOR SOME OF THE TESTING AND THIS WAY, PEOPLE
COULD GET THE RESULTS AND WHAT WE STARTED TO DO IN SOME
OF THESE CONTEXTS OF RESEARCH WAS WE WERE GIVING PEOPLE
CLINICAL RESULTS. SOMETIMES.
SOMETIMES NOT. THEN WE GOT INTO SOME
QUESTIONS ABOUT CLA AND WHAT THE IMPLICATIONS WERE FOR CLA
BUT WE DID DO??WE SAID WE’RE STUDY NOTHING THE CONTEXT OF
RESEARCH BUT IT HAS SOME IMPLICATIONS FOR THE CLINIC
AND I THINK THIS IS A MODEL WE STILL SEE HERE AND IT
PARTLY IS CONTRIBUTING TO THIS INCREASING, BLURRING
BETWEEN WHAT IS RESEARCH AND WHAT IS CLINIC AND WHAT ARE
OUR ETHICAL OBLIGATIONS AND THIS WAS VERY??A VERY, VERY,
EXCITING TIME FOR THE ELSI RESEARCH PROGRAM AND IN BOTH
IN THE CONTEXT OF CYSTIC FIBROSIS AND CANCER.
OKAY. AND THEN WE STARTED TO MOVE
ALONG AND RECOGNIZE THAT AT THE SAME TIME THERE WAS A
SCIENCE GOING ON WE WOULD WANT TO LOOK AT SOME PARALLEL
ELSI ISSUES AND HNP AND GENETIC VARIATION WERE 2
EXAMPLES OF THAT SO YOU CAN KIND OF SEE THE FUNDING OF
THE PROGRAM AND THE NEED FOR SOME RFAs WITH PARALLELLING
WHAT WE WERE SEEING GOING ON WITH THE SCIENCE.
AND THE ELSI RESEARCH PROGRAM WAS GETTING THE RECOGNITION
FROM THIS, FROM I THINK SOME OF THE COMMENTS FUND WITH
HNP, TO RECOGNIZE OKAY, WHERE’S THE EXPERTISE.
IT’S AT NHGRI, AND BRING THEM INTO SOME OF THE PARALLEL
LCRFAs. THEN ARANT 2004, KIND OF
CONSISTENT WITH THE MODEL OF NHGRI CENTERS FOR EXCELLENCE
IN SCIENCE, GENETIC DENATIONAL LIBRARY OF
MEDICINIC MEDICINE, ET CETERA.
AND I THINK THIS WAS ELIZABETH THOMPSON TOGETHER
WITH JOY AT THE END CREATED THIS IDEA OF ELSI CENTERS FOR
EXCELLENCE AND WE CURRENTLY HAVE 6 OF THESE AND 2 SMALL
YOUER P20S TO BRING TOGETHER??SMALLER P20S TO
BRING TOGETHER GOALS AND JOY WILL TALK MORE ABOUT THIS IN
THE NEXT CONCEPT CLEARANCE BUT AND THESE HAVE BEEN STUDY
INDEED SOME DETAIL OVER THE LAST 6 OR 7 MONTHS AND I CAN
COME BACK TO THAT BECAUSE I SEE THEM, I’M GOING TO RUN
OUT OF TIME BUT I KNOW IT. OKAY, THEN WHAT WE STARTED TO
DO IS TO INTEGRATE AND JOY AND GENE AND ELIZABETH WERE
INCREASE LEE INVOLVED IN THESE AND CARRY CAN THINK OF
THESE AND WE ALSO HAVE A NEW EXPERIENCE WITH CLINICAL
SEQUENCING ERIC MENTIONED THE RETURN OF RESULTS BUT
SPECIFICALLY IN THE CLINICAL SEQUENCING WHICH IS OUR NEW
PROPOSAL, YOU COULD NOT GET SCORED TO GET A GRANT UNLESS
YOU ALSO SCORED HIGH ON THE STRONG COMPONENTS WHICH WAS
ELSI. NOW THINK ABOUT WHETHER OR
NOT WE COULD HAVE HAD THAT HAPPEN AT THE BEGINNING OF
THE ELSI RESEARCH PROGRAM TO HAVE PEOPLE,
SCIENTIFIC??SCIENTISTS, CLINICIANS AND ELSI FOLKS
COLLABORATING AND WORKING TOGETHER TO PUT TOGETHER A
SIGNIFICANT GRANT IN WHICH THEY TRUSTED EACH OTHER
ENOUGH AND THEY DID IT WELL ENOUGH IN ALL 3 COMPONENTS TO
GET SCORES AND I DON’T FINISH WE CAN SAY HOW MANY BUT I
THINK IT WOULD BE MANY OF THESE APPLICATIONS.
INTERESTINGLY ALSO, THEY WERE ALSO ELSI TYPES BUT A LOT OF
PEOPLE THAT HAVE BECOME PROFICIENT IN ELSI ISSUES ARE
ACTUALLY GENETICS AND HAD HAS BEEN INTERESTING
FROM OTHERS
IN THE FIELD AND TO REALLY UNDERSTAND THEM IN THE
CONTEXT OF THE WORK AND THEN FINALLY AS ERIC MENTIONED,
INTEGRATED CONSORTIUM MODEL FAR RETURN OF??FOR RETURN OF
RESULTS. SO THIS SHOWS THE DIFFERENT
APPROACHES TO FUNDING IT, THEY’VE ALSO ADJUSTED TO WHAT
IS NEEDED IN ORDER TO GET AN INTEGRATED APPROACH WHEN
APPROPRIATE. , AGAIN THINK BEING WHAT’S
GOING TO HAPPEN WITH OBJECTIVITY.
I DO HAVE CONCERNS THAT DO WE OFTEN ASK THE NORMAATIVE
FOUNDATIONAL QUESTIONS BEFORE WE MOVE AHEAD TO ASK SOME OF
THE IMPLEMENTATION QUESTIONS. SO JUST A THOUGHT.
THIS SHOULD BE TO ALL OF YOU. I WANT TO SHOW YOU THE BREDTH
OF THE RANGE OF MECHANISMS THAT WE USE IN THE ELSI
RESEARCH PROGRAM. THE ONLY 1 THAT IS NOT NOW
CURRENTLY BEING USED IS THE EDUCATIONAL GRANTS AND THAT
IS IN DIRECT RESPONSE TO AN ASSESSMENT THAT WAS DONE
AROUND 2003, 2004 SAYING THAT WAS JUST NOT A GOOD USE OF
THE LIMITED RESOURCES TO DO THE RESEARCH IN THE FIELD.
OKAY THIS ALL LOOKS FAMILIAR TO YOU, I WOULD HOPE BY NOW
AND SO DOES THAT PATIENTS IN THE CLINIC UPPER UP ON THE
TOP AS WE MOVE TO THE RIGHT, THAT’S AN INTEREST THING TO
SAY AS WE’RE DEBATING THE REPUBLICAN DEBATE, ET CETERA,
BUT ANYWAY, MOVING TO THE RIGHT.
THERE WAS CLEAR RECOGNITION IN THIS STRATEGIC PLAN A
COMMITMENT TO DOMAIN GENOMICS AND SOCIETY. ANDOT ALL THE
WAY TO THE LEFT AND ALL THE WAY TO THE RIGHT, WHAT I
THINK IT’S INTERESTING THAT IT HAS AN AND SIGN.
SO IT MEANS GENOMIC AND SOCIETY.
ERRATIC SAID THAT STANDS FOR GAS AND MAYBE WE HAVE TO
THINK ABOUT THAT AS AN ACRONYM, BUT, I THINK WHAT IT
SAYS IS IT WORKS BOTH WAYS. SO IT’S NOT GENOMICS IN
SOCIETY, ALONE BUT THIS IS HA??WHAT SOCIETAL IMPACT IS ON
GENOMIC AND VICA VERSA. SO I’M GOING TO HAVE TO GO
QUICKLY THROUGH THESE. THESE ARE COMING OUT OF THE
STRATEGIC PLAN. THESE ARE THE 4 CATEGORIES,
BUT THEY’RE ALSO PRETTY MUCH THE CATEGORY THAT WE REALLY
HAD FROM THE BEGINNING AND YOU’LL SEE HOW THIS PLAYS OUT
A LITTLE BIT LATER. INCREASINGLY AS YOU MOVE TO
THE RIGHT, THE IMPACT OF 1 AND 2 AND THE IMPACT OF 3 AND
4, THEY’RE ALL INTERRELATED TO 1 ANOTHER BUT THEY’VE BEEN
PUT INTO THESE 4 CATEGORIES. SO THIS IS A LISTING OF WHAT
WOULD FIT WITHIN THE CATEGORY OF ETHICAL??PSYCHOSOCIAL,
ETHICAL ISSUES AND GENOMICS RESEARCH.
AS YOU CAN SEE, THERE’S REALLY NOTHING UNIQUE TO
GENETICS AND GENOMIC, THESE ARE ISSUES THAT ARE RAISED BY
ALL TYPES OF RESEARCH, EXCEPT PERHAPS THE INTERGENERATIONAL
AND THE BLOOD RELATIVE RELATIONSHIPS THAT MAY CREATE
SOME INTERESTING CHALLENGES WHEN IT COMES TO??IF YOU GET
CONSENT FROM SOMEBODY HA IMPACT MIGHT THAT HAVE BEYOND
THEMSELVES TO THEIR WHOLE FAMILY.
AND THERE SEEMS TO BE SOME PERCEPTIONS THAT GENETICS OR
GENOMIC RESEARCH MIGHT BE MORE SENSITIVE TO INDIVIDUAL
ITS THEIR FAMILIES, THAT’S THE INTERESTING QUESTION
ABOUT EXCEPTIONALLY, WHERE THAT PLAYS OUT.
LET ME JUST STOP ON COMMUNITY ENGAGEMENT.
THIS IS AN AREA WHERE WE GOT WONDERFUL SCHOLARSHIPS THAT
SPECIFICALLY HAD A FOCUS ON CONSENT AND COMMUNITY
ENGAGEMENT THE PSYCHOSOCIAL AND
ETHICAL ISSUES IN
GENOMICS MEDICINE, I DON’T THINK ANYTHING SHOULD BE
FAMILIAR HERE, I THINK THAT FIRST 1 OF GENOMIC
UNCERTAINTY IS A REAL CHALLENGE FOR US AND WHAT DO
YOU SAY WHEN WE DON’T REALLY KNOW.
HOW MUCH IS GOOD ENOUGH? WHEN DO YOU GIVE THE RESULT?
AND WHEN DO YOU THINK THAT IT’S REALLY TIME TO SHARE
INFORMATION AND WE’RE LIKE A MOVING TARGET AND A LOT OF
GOOD RESEARCH NEEDS TO BE DONE IN THAT AREA.
I DON’T SEE ANYTHING REALLY NEW IN THIS, IT’S JUST ALL
LISTED IN THE TRANSLATIONAL RESEARCH STRATEGIC PLAN.
THENCH THE LAST BROADER SOCIETAL ISSUES, THESE TEND
TO BE MOST OF THE GRANTS THAT GENERALLY DON’T COST AS MUCH
THESE ARE GRANTS THAT ARE USUALLY GIVEN TO
PHILOSOPHERS. MANY OF THESE SAME ISSUES
THAT WERE DISCUSS INDEED THE EARLY 1990S ARE STILL BEING
RESEARCHED TODAY. WHAT DOES IT MEAN?
WHAT IS IT GOING TO DO TO OUR SENSE OF SELF?
I THINK THE INDIVIDUAL AND GROUP IDENTITY ISSUE IS
BECOMING INCREASINGLY MORE INTERESTING AND MORE
IMPORTANT AND YOU KNOW FREE WILL AND INDIVIDUAL
RESPONSIBILITY IS SOMETHING WE LAWYERS LOVE TO TALK ABOUT
ALL THE TIME. OKAY, NOW THE NEXT 2 SLIDES I
WANT TO GIVE A LITTLE CAVEAT. AND I GIVE CREDIT, IF YOU
LOVE THESE, IF YOU LOVE THESE, TO JOY, IF THERE’S A
PROBLEM, I WILL TAKE RESPONSIBILITY BUT JOY AND
ELIZABETH, WE TRIED TO SQUEEZE IN FROM 1991 UNTIL
2011 INTO THESE BEST CATEGORIES AS BEST WHY
COULD??WE COULD, HOW MUCH MONEY WAS SPENT IN THESE
CATEGORIES. BUT I WANT TO GIVE THE CAVEAT
AGAIN THAT THERE IS A LOT OF INTERBLEEDING BETWEEN
CATEGORIES, AND IF YOU LOOK ALONG THE APPROXIMATE BOTTOM,
THAT WILL GIVE YOU SOME PERSPECTIVE ON HOW MUCH WAS
SPENT IN EACH OF THESE 5 YEARS AND AS YOU COULD SEE,
FROM 2001 TILL NOW, THAT’S JUST A FUNCTION OF THE EXTRA
MURAL BUDGET NOT GOING UP MUCH, AND THE FIRST 10 YEAR
10 YEAR PERIOD THERE WAS. SO SOME OF THE OBVIOUS THINGS
SEEM TO ME, THE TREND OF THE AMOUNT OF MONEY IN THE LEGAL
AND THE SOCIAL. IT WAS MUCH HIGHENER 19 NO 1
THAN IT WAS IN 2011 WHEN WE WERE FIRST GETTING STARTED
AND IF YOU LOOK TOGETHER IN 2011 THE DENATIONAL LIBRARY
OF MEDICINIC RESEARCH AND THE GENOMIC MEDICINE CATEGORIES.
NOW REMEMBER, THAT’S THE ELSI ISSUES ASSOCIATED WITH
GENOMICS AND WERE GENOMICS MEDICINE, THEY’RE ACCOUNTING
FOR ABOUT 70%. A LITTLE MORE OF 2/THIRDS OF
THE BUNCHET NOW. THAT’S THE LARGE MAJORITY OF
WHAT THE PORTFOLIO IS LOOKING AT RIGHT NOW.
WELL, WHY WOULD THAT BE? WELL, 1, WHAT’S HAPPENING
WITH THE SCIENCE? YOU MIGHT SAY, WHY WOULD 1996
SO HIGH FOR GENETIC MEDICINE AND THAT WAS THE CANCER
GENETIC CONSORTIUM, ENDING,??THERE WAS A LARGE
PRACTICE PORTION OF THE FUNDS GOING TO FUNDING CLINICAL
INTEGRATION AND THERE STILL IN IS A LARGE AMOUNT OF MONEY
GOING TO INICAL INTEGRATION AND THERE’S A LARGE AMOUNT OF
MONEY GOING TO BEHAVIORIAL AND SOCIAL SCIENCE RESEARCH
AND A LOT OF IT, THESE ARE INTEGRATED RFAs THAT ARE
ACCOUNTING FOR THIS? AND I DON’T KNOW WHAT ELSE TO
SAY ABOUT THIS BUT I’M HAPPY TO ANSWER ANY QUESTIONS.
BUT WHAT IT DOES SO IS THE MATURATION OF THE PROGRAM BUT
A LITTLE BIT OF CONCERN ABOUT WHETHER WE’RE DOING ENOUGH ON
THE LEGAL AND THE SOCIAL ISSUES.
MAYBE THAT SUPPORT A CONCERN. NOW I WANT TO COMPARE TO THIS
IS THE NUMBER OF GRANTS, SO IF YOU LOOK AT THE NUMBER OF
GRANTS. IT’S MOSTLY PARALLEL, THE
OTHER CHART BUT YOU SEE A LARGER PERCENTAGE BY NUMBER
OF LEGAL AND SOCIAL AND THAT’S BECAUSE OF INEXPENSIVE
GRANTS. THOSE ALSO TEND TO BE
INVESTIGATOR INITIATED BUT NOT TOTALLY BUT THE RETURN OF
RESULTS PROPOSAL HAD IN FACT SOME OPPORTUNITY FOR SOME OF
MOZ MORE NORMAATIVE STUDIES BUT THAT GIVES YOU A SENSE OF
THE TREND AS WELL, IF YOU LOOK AT THE BOTTOM AS YOU CAN
SEE, WE JUST HAVE LESS GRANTS EVEN THOUGH WE HAVE MORE
MONEY, WE HAVE LESS GRANTS THAN THE HIGH IN FACT OF
2001. AND THAT’S BECAUSE THESE
INTEGRATED SOCIAL AND BEHAVIORIAL SCIENCE WITH A
LOT OF IMPERICAL WORK ARE JUST MORE EXPENSIVE GRANTS.
SO WE CAN’T SPREAD QUITE AS MUCH AS IF THERE WERE A LOT
OF LITTLE SMALL GRANTS. WELL, THAT’S OBVIOUS.
SO THAT’S HOW THEY’RE PLAYED OUT.
NOW IT’S INTERESTING IN 1991, THEREYA’S LOT OF??THERE’S A
LOT OF HUMAN, BUT HUMAN BECAUSE EVERYBODY’S GRANT HAS
THE TITLE, HUMAN GENOME RESEARCH, MAPPING THE HUMAN
GENOME ETHICAL IMPLICATIONS. SO THAT’S WHERE WHY YOU SEE
HUMAN BUT THIS IS MORE INTERESTING TO ME.
SO THIS WAS 2000 EXPLEVEN LOOK OW BIG RESEARCH IS,
THERE SO THAT ETHICAL IS LIKE A LITTLE THING OVER THERE AND
I THINK LEGAL’S A LITTLE SMALLER BUT RESEARCH THAT SO
MUCH OF THE ETHICAL LEGAL, AND SOCIAL IMPLICATIONS
PROGRAMS FOCUSES, WHAT IS THE IMPLICATION OF GENOMIC
RESEARCH? AND I DON’T KNOW WHAT TO MAKE
OF THAT BUT I THINK THAT SAYS SOMETHING.
THAT SAYS A LOT ABOUT THE INTEGRATION OF THE PROGRAM.
>>ARE THE GRANTS THEMSELVES RESEARCH GRANTS?
>>YEAH BUT THAT WOULDN’T BE IN THE TITLE.
>>OH I SEE.>>YES.
>>YES!>>OKAY, SO THEN WE DID
ANOTHER ANALYSIS BUT BASED ON DATA SETS WE COULD ONLY GO
BACK A NUMBER OF CERTAIN YEARS AND THIS IS BY THE
NUMBER OF ACARDS BY METHOD. ??AWARDS BY METHOD.
THIS IS BECAUSE I HAD CONCERN TAC WE DIDN’T HAVE ENOUGH
DIVERSITY IN THE KINDS OF METHODS THAT WERE BEING USED
TO DO RESEARCH SO THERE WERE 141 AWARDS OVER THIS PERIOD
OF TIME AND BY??YOU COULD SEE ON THE LEFT?HAND SIDE BY
MULTIPLE METHODS, THAT ACTUALLY SPEAKS TO AGAIN
INTERDISCIPLINARY WORK. IT MEANS PEOPLE FROM
DIFFERENT DISCIPLINES OR SKILLS WITH DIFFERENT METHODS
HAVE GOTTEN TOGETHER TO BE ABLE TO ADDRESS SOME OF THE
FOCUS ON SOME OF THESE RFAs THAT REALLY REQUIRES TO BE
SUCCESSFUL YOU HAVE MULTIPLE METHODS, IF YOU LOOK ALONG
THE RIGHT LEGAL ONLY AND CONCEPTUAL ONLY, THOSE TEND
TO BE THOSE IN THAT THIRD AND FORTH CATEGORY AND THE OTHER
JUST TEND TO BE DATABASES AND THINGS LIKE THAT.
AND THEN I ALSO WANTED TO SEE BECAUSE OF 1 OF THE CRITIQUES
FROM THE ELSI RESEARCH PROGRAM IS IT DOESN’T
REALLY??YOU KNOW I WANT TO SAY THIS IN A POSITIVE WAY, COULD
IT BE DOING MORE TO ACTUALLY HAVE AN IMPACT ON POLICY.
AND AGAIN, A REVIEW WITH SOME OF THE PEOPLE IN THE POLICY
SHOPS HELP THE ASSESSMENT, ALICE AND LORA HELPED WITH
THIS AS WELL, IN LOOKING AT THEM REGUARDLESS OF WHAT
CATEGORY THEY WOULD PLACE THEM IN, WE DID A SEARCH
BASED ON THE AIMS AND WHETHER OR NOT THEY HAD THE GOAL OF
COMING UP WITH SOME SORT OF REGULATORY OR POLICY
DEVELOPMENT AND AS YOU CAN SEE ALMOST HALF OF ALL THE
GRAPTS FUNDED OVER THIS HAD TIME PERIOD DID.
AND I THINK THAT’S UNDERESTIMATION.
BECAUSE, AS YOU MOVE IN YOUR RESEARCH, YOU’RE GOING TO
INCREASINGLY IMPACT POLICY EVENTUALLY, BUT AS PART OF
THE SPECIFIC AIMS ON THESE, THEY’VE SPECIFICALLY BENCH
AND BED. OKAY, SO THAT WAS MY 5
MINUTES, I HAVE LEFT, I WANT THE TO BROADEN OUR SCOPE PAST
THE EXTRA MURAL PROGRAM. AND THIS IN PART IS BECAUSE
OF THE OTHER HAT I WEAR, SO HALF OF MY TIME IS SPENT IN
THE BIOETHICS PROGRAM AT THE CLINICAL CENTER, WORKING WITH
THE BIOETHICS CORPS WHICH IS MOSTLY SARAH PAUL AND BEN
BERK MAN WHO ARE INCREDIBLY TALENTED AND WORK WITH NHGRI
AND THE INTRAMURAL PROGRAM AND RIGHT ABOUT ISSUES IN THE
FIELD AND THE SECOND THE SECOND BRANCH AND THE SOCIAL
AND BEHAVIORIAL RESEARCH BRANCH AND DIRECTOR, WORK,
COLLEEN MCBRIDE’S BRANCH AND BACTERIA THERE IS 1 OF THE
MEMBERS OF THAT AS WELL AND HE DOES VERY INTERESTING WORK
HE DOES INTERESTING WORK IN THE INTRAMURAL PROGRAM, VERY
INTERESTING WORK ON THE ROLE OF RATES AND INTERESTS OF
PHYSICIANS AND HEALTHCARE PROVIDERS AND THEN THERE ARE
OTHERS THAT ARE PRIMARILY MEDICAL OR CLINICAL BUT ALSO
CARE AND ARE INVOLVE WIDE ELSI ISSUES WITH BRANCH AND
BRANCH FOR EXAMPLE, AND OF COURSE, THE OFFICE OF POLICY
COMMUNICATIONS AND EDUCATION AND THE ABILITY TO DO BETTER
EVEN BETTER AMONGST ALL THESE COMPONENTS SO THAT THE ELSI
RESEARCH PORTFOLIO CAN INFORM WHAT’S GOING ON WITH THE
EVOLUTION OF POLICY AND THE POLICY SHOP CAN TELL US
WHAT’S EMERGING AS NEW ISSUES THAT IN FACT WE COULD BE
DOING MORE RESEARCH ON AND WE COULD LEARN FROM THE
INTRAMURAL PROGRAM WHO’S DOING A LOT OF WORK IN THE
RETURN OF RECUTS AND THE??RESULTS AND THE ISSUES
WITH IRBASKS WHAT WE COULD LEARN FROM THERE, SO THIS
WOULD BE BETTER INTEGRATION AND MORE OF A CRITICAL MASS
AT NHGRI ALONE NOT TO MENTION THE REST OF NIH.
OVER THE LAST FEW MONTHS SWREE BEEN BRAINING TOGETHER
THE INTRAMURAL FOLKS, THE POLICY FOLKS, AND THE
EXTRAMURAL FOLKS ON THE GROUND TO TALK WITH EACH
OTHER ABOUT WHAT IT MEANS TO DO DENATIONAL LIBRARY OF
MEDICINICS SOCIETY RESEARCH. AND ON THE LEFT?HAND SIDE, WE
LISTED ALL THE POTENTIAL DISCIPLINES THAT WE COULD BE
ENGAGING WITH TO TALK ABOUT AND TO ENRICH OUR RESEARCH
AND ON THE RIGHT HAND SIDE, ALL THE POTENTIAL METHODS
THAT WE COULD BE USING TO DO RESEARCH AND THEN ALONG THE
BOTTOM, REMEMBER THIS IS DRAFT, ALONG THE BOTTOM A
CONTINUUM THAT PROBABLY SHOULDN’T BE NEXT TO EACH
OTHER BUT IN SOME THEME I COULDN’T DEVELOP AT THIS
POINT ON THE CHART BUT IF YOU LOOK ALONG TO THE RIGHT,
MOVING FROM BASIC KNOWLEDGE TO TOOLS AND METHODS TO
VALIDATED INTERVENTIONS, TO RESEARCH GUIDANCE TO PRACTICE
GUIDANCES, TO THE MAKING OF PUBLIC POLICY AND HOW I WOULD
INTERACT WITH 1 ANOTHER. NOW, MORE IMPORTANT THAN WHAT
IS SAID ON THIS CHART IS THE FACT THAT EVERYBODY WITH GOOD
WILL IS WORKING TOGETHER TO TRY TO THINK OUTSIDE THE BOX,
TO HOW WE COULD FURTHER ENRICH OUR GENOMIC SENSE AND
SOCIETY RESEARCH, NOT OLDSMOBILE AT NHGRI, BUT
BEYOND. AND THAT’S WHERE I WANTED TO
LEAVE YOU. SO, THE FIRST QUESTION IS AT
NHGRI, HOW COULD WE DO BETTER INTEGRATING TO ENRICH NOT
OLDSMOBILE ONLY WHAT WE TALK ABOUT HERE, BUT BEYOND NHGRI
AND GENOMICS AND OTHER NIH INSTITUTES.
THERE’S NOT AN ELSI RESEARCH PROGRAM IN ANY OTHER NIH
INSTITUTE. BUT THE LARGE PROPORTION OF
THE BUDGET TO DO GENOMICS RESEARCH IS NOT AT NHGRI, I
MEAN IT’S IN OTHER INSTITUTES AND THEY HAVE THESE SAME
ISSUES THAT THEY’RE DEALING WITH, AND THEY NEED US AND WE
NEED TO WORK TOGETHER EMPLOY. AND I THINK COMING FROM THAT,
WE’LL PROBABLY BE MORE INVOLVEMENT WITH MORE
INSTITUTES CONTRIBUTING TO COLLABORATION, WE STARTED TO
DO IT BUT WE COULD DO MORE OF IT.
AND THEN BEYOND NIH, THERE ARE A LOT EVER OTHER FEDERAL
AGENCIES AND ORGANIZATIONS AND I LOOKED BACK IN 1990 AND
91, WE HAD AN AGREEMENT WITH THE NATIONAL ENDOWMENT FOR
THE HUMANITIES TO WORK TOGETHER ON 1 OF OUR
RAGRANTS. WE COULD BE DOING MUCH MORE
OF THAT. AND THEN OF COURSE, WE KNOW
WE HAVE TO BE??MUCH MORE LIKE IN THE SCIENCE WHERE WE HAVE
INTERNATIONAL CONSORTIUMS TO SHARE, SAMPLE AND TO SHARE
OUR IDEAS. WE NEED TO BE MUCH MORE
EXPANSIVE IN THIS AREA AS WELL.
WE CAN REALLY LEARN A LOT AND WE CAN COLLABORATE.
SO OUR SENSE OF WHAT SOCIETY MEANS COULD BE A LOT RICHER.
SO I THINK I’M DONE AND I REALIZE I DIDN’T LEAVE MUCH
TIME FOR QUESTIONS. COULD I HAVE A FEW MINUTES
MAYBE?>>I WAS JUST A LITTLE BIT
CONFUSED ABOUT HOW YOU WERE SHOWING THE LEGAL OR ETHICAL
AND SOCIETAL WENT DOWN,??SORRY, WEPT DOWN.
>>THE GRANTS OR MONEY?>>EITHER 1: AREN’T THE
LEGAL SOCIETAL THINGS INCLUDE INDEED GENOMIC MEDICINE AND
RESEARCH, SO DID YOU LOSE OUT BY NOT HAVING IT?
THAT’S WHAT I WAS NOT SURE ABOUT.
>>THAT’S A GOOD BUOYANT. WHEN I SAID THE CAVEAT ABOUT
HOW THEY GET??SO WE PUT THEM IN THERE WITH A PRIMARY
PLACE. IN AN IDEAL GRANT FOR THE
FIRST OR SECOND CATEGORY IT WOULD BE WONDERFUL TO HAVE
PEOPLE THAT HAVE THOSE SILLS TO BE INTEGRATED INTO THAT
GRANT AND THEY VALID BEEN PUT PRIMARILY IN THE FIRST OR
SECOND CATEGORY, AND I THINK YOUR POINT IS, IS IT POSSIBLE
THAT IT’S JUST UNDER ESTIMATING HOW MUCH OF VALUE
IS IN THOSE OTHER GRANTS. IT MIGHT BE, BUT WE MAY NEED
TO BE, THERE’S A PERCEPTION THAT WE’RE NOT SPREADING THE
WEALTH ENOUGH TO ENOUGH DISCIPLINE AND ENOUGH AREAS
AND WE HAVE TO BE MINDFUL OF THAT BUT IT’S A VERY GOOD
POINT. SO I’M LESS??ABOUT SPREADING
THE WEALTH AND WHETHER THE COVERAGE OF THE TOPICS ARE
NOT BEING DONE, IS IT YOUR PERCEPTION WE NEED TO DO MORE
OF THAT? WELL, I HATE TO GENERALIZE
BUT I DO THINK THERE’S SOME PEOPLE THAT ARE PROBABLY
HURTING, SOMETIMES WE MAY JUMP THE GUN A LITTLE BIT.
THE AND IF I COULD GO BACK A FEW YEARS, I WOULD SAY, WOW,
I WISH WE WOULD HAVE FUNDED MAYBE SOME MORE NORMA 75
ANALYSIS OF THE FOUNDATION BEYOND WHY WE HAVE SOME SORT
OF EVOLVING OBLIGATION TO RETURN RESEARCH RESUMMITS.
AND I THINK NOW WE’RE TALKING ABOUT THE SOCIAL IMPLICATION
OF RETURNING THE RESULTS, AND LITTLE BIT MORE DEPTH OF
SCHOLLORSHIP THAT HAD JUST BEEN ON SOME OF THOSE
PORTIONS SO THAT MIGHT HAVE BEEN AN EXAMPLE OF THAT.
YEAH, AMY.>>ON THAT LINE HAVE YOU DONE
OR PLAN TO DO A NEEDS ASSESSMENT, THOSE WITHIN THE
COMMUNITY AND THE SCIENTIFIC COMMUNITY OF WHAT ARE THE
PERCEIVED NEEDS NOW, IN TERMS OF WHERE THE FUNDING SHOULD
BE GOING. I THINK THAT’S A GREAT
QUESTION. I’VE ONLY DONE IT INFORMALLY
AND THROUGH THE SEER STRUCTURE AND OF COURSE THOSE
ARE SUCCESSFUL GRANTEES. I THINK WHAT WE HAVEN’T HAD
FOR THE LAST FEW YEARS AND ERIC AND I TALKED A LITTLE
BIT ABOUT THAT, THERE’S NOT AN ADVISORY GROUP.
THERE ISN’T AN ADVISORY COMMITTEE TO ELSEY AND I
THINK AS WE EVOLVE AND MOVE FORWARD, THAT WOULD BE VERY
HELPFUL, EITHER AS A SUBGROUP HERE WHERE WE WOULD BRING
SOME OTHER PEOPLE TO THE COMMUNITY AND THEN TALK ABOUT
THAT AND FIGURE THAT OUT BUT THAT’S A REALLY GOOD POINT
AND YES, THAT NEEDS TO BE DONE.
>>I WANT TO THANK YOU FOR YOUR OVERVIEW, IT’S REALLY
VERY HELPFUL IN GIVING A SENSE OF YOU KNOW THE
EVOLUTION OF THE ELSI PROGRAM AND WHAT I DIDN’T GET FROM
YOU AND I NOT SURE HOW EASY THAT IS, TO DO 2 SETS OF
QUESTIONS. WHAT HAVE BEEN THE SUCCESS OF
THE ESLI PROGRAM AND ARE THERE TIEWPTS IN THE RESEARCH
PERSPECTIVE, YOU TALKED ABOUT MISSED OPPORTUNITIES IN TERMS
OF AND RESEARCH POLICY BUT THERE ARE OTHER BIG MISSED
OPPORTUNITIESA WE ARE AWARE OF AS WE ASK FOR THE FUTURE
AND THEN I HAVE A SECOND QUESTION.
>>OKAY, I THINK IT’S ALWAYS INTERESTING TO BE A MONDAY
MORNING QUARTERBACK SO LET ME TALK FIRST ABOUT WHERE I
THINK SOME OF THE MAJOR POSITIVES WERE FIRST OF ALL
THE IDENTIFICATION OF TISSUE SAMPLES, WHAT YOU NEED TO
HAVE CONSENT FOR, THE RICHNESS OF OF THAT
CONVERSATION WAS STARTING IN THE 1990S, MIDNIGHTS BUT I
THINK A LOT OF THAT GOT MOVED ALONG RAPIDLY BY SOME OF THE
INITIAL WORK THAT WAS DONE COMING OUT OF THE ELSI
RESEARCH PROGRAM IN THE EARLY??AROUND 1994, I THINK,
AND WE’RE STILL TALKING ABOUT IT AND WE SEE IT NOW COMING
UP AS WE CHANGE THE COMMON RULE.
SO I THINK THAT WHOLE AREA GOT A SHOT IN THE ARM FROM
THE ELSI RESEARCH. NOW??THE OTHER AREA I WAS
THINKING ABOUT IS GENETIC NONDISCRIMINATION AND
PRIEFACY, AND THE ULTIMATE PASSAGE, I DON’T KNOW HOW
MUCH OF THAT CAME FROM HAVING A RESEARCH PROGRAM AS MUCH AS
WHAT IT MEANS SYMBOLICALLY TO THE COMMUNITY AS WELL
OUTSIDE. SO FROM IS A STUDY THAT CAME
OUT THAT SHOWED JUST ABOUT 20% OF ELSI RESEARCH IS
FUNDED BY NHGRI, MUCH OF IT DOESN’T FUNDED AT ALL, SO THE
STIMULUS OF THE RECOGNITION MAY HAVE STIMULATED THAT, SO
FOR THE AMOUNT OF MONITOR THAT’S WE GAVE TO THE WORLD,
YOU KNOW? NOW WHAT DID I SAY 280
MILLION, WE’VE ESTABLISHED THIS MUCH LARGER PORTFOLIO.
WOULD THAT HAVE HAPPENED EVEN IF THERE HASN’T BEEN ANY OF
THIS? WHO KNOWS, I DON’T KNOW.
I HAVE SOMEBODY THAT WAS IN THE FIELD THEN, I MOSTLY
UNSUCCESSFULLY APPLYING FOR GRANTS, YOU KNOW?
I THEN WOULDN’T GET IT AND DID IT ANYWAY.
YOU KNOW SO IN MY FIELD OR IN PHILOSOPHY OR LAW AND THOSE
FIELDS, THE INVESTMENT ISN’T QUITE AS DEEP AS IT WOULD BE
FOR SOMEBODY THAT DOES IMPERICAL WORK.
I THINK PROBABLY THE GREATEST SUCCESS IS WHAT I SAID ABOUT
THIS RECENT CLINICAL SEQUENCING GRANT.
THAT WE HAD CREATED A GENERATION NOW THEATBOTH WAYS
OF SOCIAL SCIENTISTS AND OTHER PEOPLE THAT ARE NOT
SEEN PRIMARILY AS MEDICAL OR HEALTHCARE PROFESSIONALS WHO
KNOW HOW TO INTERACT COLLABORATIVELY WITH THE
SCIENTIFIC COMMUNITY AND VICE VERSA AND THAT THERE IS SORT
OF THIS EVOLUTION THAT TOOK MAYBE THE ELSI RESEARCH
PROGRAM TO DO AND AGAIN, I DON’T HAVE IMPERICAL DATA TO
BACK THIS UP, BUT WE HAVE A ROBUST AND MOVING FORWARD
SCIENTIFIC AGENDA THAT I THINK HAS BEEN ENHANCED BY
THE FACT THAT THERE HAS BEEN A RECOGNITION AND A
SERIOUSNESS OF THE FACT THAT IT’S MESSY AND IT’S NOT ALL
OICISM THEY’LL WE’RE JUST GOING TO MOVE FORWARD AND YOU
KNOW, WE CAN’T DO CERTAIN THINGS WE MIGHT WANT TO DO IF
WE DON’T GET CONSENT FROM PEOPLE TO DO THEM.
MAYBE WE WOULD WANT TO BUT SO THAT DIALOGUE, IT’S MESSY,
BUT IT HAS ENRICHED, I THINK THE RECOGNITION ON BOTH SIDES
SO THAT’S NOT A SPECIFIC STUDY, BUT IT’S ALMOST JUST
SORT OF A MESSAGE. DOES THAT??DOES THAT HELP?
>>MIRROR IMAGE SECOND QUESTION WHICH MAY BE LESS
FOR YOU, MAYBE EVEN FOR ERIC BUT AS I LIFIC TO YOUR
OVERVIEW OF THE QUESTIONS AND THE GOALS AND THE MISSION, IT
SEEMED TO ME THAT RARELY CRITICAL ISSUE THAT’S NOTED
BY SOME GENETICISTS AND CERTAINLY MANY SOCIAL AND
BEHAVIOR YALE SCIENTIST PERCENT THE SCIENTIST SYSTEM
TO UNDERSTAND AS WE BED GENETIC HOW GENETICS ISHT ACT
WITH THE ENVIRONMENT AND THAT WE REALLY HAVEN’T TAKEN VERY
SERIOUSLY, THE SOCIAL ENVIRONMENT AND REALLY BEGAN
TO CREATE THE SOCIAL GENOME IF YOU WANT TO CALL IT THAT.
AND CHARACTERIZE EEXPOSURES SPECIFIC, SPECIFIC EXPOSURES
SOCIAL AND SOCIAL SOCIAL SOLDIERS AND UNDERSTAND HOW
THEY INTERACT WITH THE GENETICS AND HOW YOU KNOW WE
CAN GET EPIY GENETIC EFFECTS FROM EXPOSE TOWER DISTINCTIVE
SOCIAL EXPOSURE. AS YOU OUTLINE WHAT ELSI
PROGRAM DOES, I THOUGHT IN MY MIND THE PROGRAM SAW ITSELF
AS POSSIBLY BEING A LEADER AT LEAST, NOT NECESSARILY HAVING
THE RESOURCES BUT THINKING THIS, IS VERY DIFFICULT TO
DO. I MEAN FROM MULTIPLE
PERSPECTIVES, BUT I THINK IT’S A REAL PRIORITY FOR THE
FUTURE AND IT DIDN’T SEEM TO BE PART OF THE MANDATE OF THE
ELSI PROGRAM AS YOU DESCRIBE, IF IT’S NOT THE ELSI PROGRAM
WOULD THEN WOULD IT TAKE ON THIS MAJOR RESPONSIBILITY?
>>YEAH, YEAH. GREAT QUESTION.
ROOK.>>THE QUESTION I WAS GOING
TO ASK WHEN I THINK COULD LEAD TO AN ANSWER HERE IS
WHEN DID YOU HAVE THE OPPORTUNITY TO TALK WITH
OTHER INSTITUTEHOW TO INTEGRATE THE WORK THAT WE DO
WITH THEM BECAUSE A LOT OF THE EPIY GENETICS ISN’T HERE,
IT’S ELSEWHERE AND THAT’S 1 OF THE MOST IMPORTANT FUTURE
LIMITING THINGS IS TO START TO DO TO REALLY BUILD
PROGRAMS WITH OTHER INSTITUTES.
OKAY, FIRST??>>OKAY, FIRST OF ALL, IT’S A
GREAT QUESTION. BECAUSE I DIDN’T HAVE ENOUGH
TIME. BUT THE SEER PROGRAM HAS A
P20, WOVEN THE SMALLER CENTERS THAT IS FOCUSED ON
EPIY GENETICS IN ORGANIZATIONSON, THAT IS THE
PI AND THAT IS NANCY, AND THE SEER AT THE UNIVERSITY OF
WASHINGTON, WHICH IS THE PI IS WILY BERK, AND THEY HAVE
DONE MORE AND MORE OF LOOKING AT THAT VERY QUESTION, YOU
MIGHT KNOW ABOUT THAT. AND IT IS A PRIORITY AREA
HEAR THE ELSI RESEARCH PROGRAM AND IT BE DOING MORE
OF THAT. NOW I THINK THE PAM’S POINT
THEY WANTED TO BUILD ON, REALLY GOES BEYOND THE ELSI
RESEARCH PROGRAM AND NOT THE??AND BEYOND PART OF WHAT
IT WOULD MEAN FOR THE INSTITUTE TO REALLY BE THE
LEADER AT NIH ON GENOMICS AND SOCIETY AND NOT REALLY GO
BEYOND THE EXTRAMURAL PROGRAM.
THAT WOULD MEAN THAT WE WOULD BE SEEN ON THE NIH CAMPUS
JUST LIKE THE ELSI PROGRAM IS SEEN, BUT BEYOND THAT BEING
ABLE TO BRING TOGETHER THE CRITICAL MASS, REGUARDLESS OF
WHERE THEY SIT. THEY COULD BE IN THE POLICY
SHOPS, THAT CAN BE IN THE INTERNATIONAL CLASSIFICATION
MA MURAL PROGRAM, THEY COULD BE IN THE EXTRAMURAL PROGRAM.
THEY COULD BE IN THE FOGARTY, THEY COULD BE ANYWHERE.
AND THERE WOULD BE A CRITICAL MASS THAT WOULD BE WORKING
TOGETHER TO ENGAGE AND TALK ABOUT WHERE WE NEED TO GO
WITH THESE THINGS IN IN THE FUTURE AND DIFFERENT
INSTITUTES BRING DIFFERENT EXPERTISE.
BUT WE ARE ALREADY 20 YEARS AHEAD IN SOME WAYS.
THAT’S WHERE I SEE THE AND BEYOND.
SO GREAT QUESTION. JEFF’S NOT GOING TO TALK TO
ME. OKAY.
>>I HAVE A MILLION QUESTIONS BUT THE 1 I’LL ASK IS, DID
YOU SPEND ANYTIME LOOKING AT WHAT I’LL CALL A
COMMUNICATION OR IMPLEMENTATION GAP.
IN FROM WHERE I SIT,OT REAL LIFE SIDE AND HAVING TO
RESPOND TO ARE REAGENTSULATIONS GUIDANCE TO
GET THE SAME MONEY FROM THE INSTITUTION AND OFTEN TIMES
YOU GO, YOU KNOW THIS IS COMPLETE LOFTS OFF BASE
OR??COMPLETELY OFF BASE. I FEEL LIKE ELSI RESEARCH IS
GOING ON BUT IT NEVER CROSS POLLENATES. AND I THINK THE
DISCUSSION THAT HOWARD AND RICHARD HAD AT THE ENCODE,
PEOPLE DON’T KNOW WHAT NHGRI IS.
I DON’T FEEL LIKE YOU ADEQUATELY COME OUT, LIKE THE
PRIMER OR ETHICS GROUP, I WANT TO GET A SENSE OF THAT.
>>YEAH IT’S A GOOD POINT AND IT’S TRUE.
SO I’D LIKE TO ASK A QUESTION: HOW MANY OF YOU
KNOW IF YOU GO ON THE NHGRI WEB SITE, HOW MANY OF YOU
KNOW THAT EVERY ELSI RESEARCH GRAPT THAT HAS EVER BEEN FUND
SIDE ON THERE? AMY?
MIKE. OKAY.
I DIDN’T KNOW THAT AND I HAD LOOKED AT MONEY IN THE PAST
EVERY SINGLE GRANT FROM THE BEGINNING AND BY NAME AND BY
SEARCH TERM. SO FIRST OF ALL THAT’S AN
INCREDIBLE RESOURCE. IT SEEMS TO ME THAT YEAR NOT
UTILIZING EVEN WITHIN NHGRI, SO THE??THE INTRAMURAL PEOPLE
DOING MERCHANDISE AN AREA CAN GO ON TO THAT WEB SITE AND
THE POLICY PEOPLE THAT ARE TRYING TO WRITE SOMETHING ON
SOME ISSUE, BESIDES LOOKING AT THE PUBLICATION YOU KNOW
WHEN ARE ONLY PART OF THE STORY, THEY COULD FIND SO
MUCH MORE. I DON’T WANT THE TO USE THE
TERM MARKETING BUT THERE IS A PRESIDENT’S COMMISSION, NEVER
MIND GUATEMALA, THEY’RE LOOKING AT HOLDING SEQUENCING
FROM GENES TO GENOMES, WE NEED TO DO BETTER AT BEING
ABLE TO SHARE WITH THEM EVERYTHING THAT WE HAVE
FUNDED. AND THE POLICIES THAT WE HAVE
AND THIS IS VERY MUCH NEEDS TO BE MORE OF A PRIORITY AND
IN FACT, I THINK IF WE DO A BETTER JOB AT INTEGRATING BY
DEFINITION, TELL BE GOTTEN BETTER.
>>FOLLOW UP ON THAT.>>IS SEEMS TO ME THAT
THE??THAT SORT OF GAP COMES IN AND THOSE ALMOST 50% OR JUST
OVER 50% WHERE GRANTS THAT CLAIM TO HAVE A POLICY IMPACT
OR DO SOME SORT OF POLICY RESEARCH, RIGHT?
SO IT MIGHT BE INTERESTING TO LOOK AT WHAT ARE THE METHODS
OF BEING USED IN THOSE BROG ECTOMYOSINS AND ARE THEY
EFFECTIVE OR NOT. AND ACTUALLY MAKING THAT SORT
OF CROSS OVER BECAUSE THAT’S??I THINK WHERE YOU??YOU
GET THE CROSS POLLINATION IS IN THE PROJECTS THAT ARE SET
UP TO HAVE SOME SORT OF POLICY IMPLICATION AND ARE
THEY DOING THAT OR NOT.>>WELL WE COULD HAVE A
DEEPER SENSE OF IT OF WHAT’S COME OUT OF THOSE, WRITTEN OR
NOT WRITTEN, I MEAN PUBLICATIONS ARE NOT
PUBLICATIONS BUT AND IN FACT 1 OF THE CENTERS FOR
EXCELLENCE DOWN AT DUKE NOW IS DOING A PROGRAM WITH THEIR
STUDENTS DOING A SIMILAR SORT OF PROJECT RIGHT NOW, LOOKING
AT SORT OF THE POLICY EVOLUTION AND THE DEVELOPMENT
SO IT’S A GOOD POINT.>>SO DURING THE INTRODUCTION
ERIC MENTIONED SOME NHGRI INITIATIVES THAT PARTS
TELEVISION WENT OUT TO OTHER PLACES, NCATS, OTHER PLACES,
WHAT’S YOUR TAKE ON WHETHER ELSI SHOULD BE SPUN OUT TO
NCATS OR SOME OTHER ENTITY THAT ALLOWS CROSS
POLLENNATION TO MORE EFFECTIVELY OCCUR.
BECAUSE IN SOME QUALIFIER AND IMPROVINGS IT’S NHGRI’S 20
YEAR EXPERIENCE AND OTHER PEOPLE THINK, WELL, NNG
RI,’LL JUST DO IT.>>SO I GUESS IT’S A
PHILOSOPHICAL DECISION ABOUT WHAT’S THE BEST STRATEGY.
THERE HAVE BEEN INCREASINGLY, ALTHOUGH WHEN MONEY IS TIGHT,
PEOPLE ARE TIGHT WITH THEIR MONEY, THE NC I, NICHD HAVE
JOINED TOGETHER TO DO SOME JOINT ELSI PROJECTS WHERE
WE’VE TAKEN THE LEAD AND WORKED OTHER WAYS, TOO.
THE SEER PROGRAM HAS AN WOES OF ITSELF 3 PRIORITIES
TRAINING AND SOME OF THE INDIVIDUALS THAT HAVE BEEN
TRAINED THROUGH THE SEER PROGRAM ARE NOW HERE AT NIH.
BUT NOT AT NHGRI. SO I THINK THOSE WILL BE WAYS
FOR US TO BETTER CROSS FERTILIZE I THINK THE NHGRI
PROGRAM NEEDS TO BE SOMEWHERE ELSE IS NOT SOMETHING I WOULD
BE PART OF. IT’S UNIQUE AND IT’S
SOMETHING THAT THIS INSTITUTE SOME BE PROUD OF AND JUST
LIKE THE PRECURSOR NONAPOPTOTIC NCAT, THAT WAS
GERMINATED AT NHGRI. A LARGE PART OF IT, ERIC
CORRECT ME IF I’M WRONG WAS GERMINATED HERE AND I THINK
JUST LIKE WE WERE THE LEADER TO MAP THE HUMAN GENOME.
THE PARADOX IN SOME WAYS, AS I THINK GENE POINT THD OUT TO
ME IS THAT THIS WAS THE INSTITUTE THAT MADE THIS
COMMITMENT EVEN WHEN WHEN WE WEREN’T DEALING WITH HUMAN
BEINGS AND WE HAVE CREATED THE EXPERTISE TO LEAD AND I
THINK WE SHOULD BE LEADING, I DON’T THINK WE SHOULD BE
RECEIVING. SO THAT’S FROM MY PERSPECTIVE
AND I THINK IT’S SOMETHING WE SHOULD BE PROUD OF AND WE
SHOULD FIGURE OUT HOW TO BETTER INTEGRATE IT WITH NIH
BUT NOT LEAVE IT BEHIND.>>OKAY.
ON THAT NOTE I THINK WE’LL LEAVE THIS??THIS IS CLEARLY
FUTURE DISCUSSION AS WE SORT OF THINK ABOUT THE FUTURE OUR
DENATIONAL LIBRARY OF MEDICINIC SOCIETY PROGRAM.
KAREN THANK YOU VERY MUCH

Leave a Reply

Your email address will not be published. Required fields are marked *