GOOD AFTERNOON, THANK YOU FOR
JOINING US TODAY IN A VIRTUAL
SETTING.
WE'RE APPRECIATIVE TO HAVE
EVERYONE JOINING US ON WEBCAST
TODAY.
I'M THE ACTING DIRECTOR FOR
SCIENCE POLICY AT THE NATIONAL
INSTITUTES OF HEALTH.
PLEASED TO WELCOME OUR MEETING
PARTICIPANTS AND THOSE VIEWING
TO OUR SECOND NIH HOSTED MEETING
AIMED AT HEARING PERSPECTIVES ON
U.S. GOVERNMENT BIOSECURITY
OVERSIGHT FRAMEWORK.
OUR FOCUS WILL BE ON U.S.
GOVERNMENT POLICY FRAMEWORK FOR
OVERSUES OF DUAL USE RESEARCH OF
CONCERN, REFERRED TO AS DURC.
THIS IS A PUBLIC MEETING
VIDEOCAST BY NIH, A VIRTUAL
SETTING TO KEEP ABREAST OF THE
ONGOING PANDEMIC, APPRECIATIVE
FOR THE FLEXIBILITY OF
PARTICIPANTS AND MEMBERS JOINING
US.
THANK YOU TO SPEAKERS AND
MODERATORS AS WELL AS MEMBERS OF
THE NATIONAL SCIENCE ADVISORY
BOARD FOR BIOSECURITY, ALSO ABLE
TO JOIN US.
BEFORE WE BEGIN I'D LIKE TO
START WITH HOUSEKEEPING.
FOR EACH SESSION WE'LL ASK
MODERATOR AND PANELISTS TO TURN
CAMERAS ON, KEEP MICS MUTED WHEN
NOT SPEAKING, OTHERS WILL LEAVE
CAMERAS OFF UNTIL THE DISCUSSION
PORTION OF THE SESSION AND TURN
IT ON IF YOU ASK A QUESTION.
WE'LL USE THE RAISE HAND
FUNCTION FOR DISCUSSION AND
MODERATORS WILL CALL ON YOU.
TURN CAMERAS ON WHEN ASKS A
QUESTION SO WE CAN SEE YOU.
SO, I WILL KICK US OFF TODAY TO
TALK ABOUT OUR GOALS FOR TODAY'S
MEETING AND SOME BACKGROUND ON
DURC RESEARCH HERE.
AS WE'RE WELL AWARE, LIFE
SCIENCES RESEARCH INVOLVING
PATHOGENS IS ESSENTIAL TO
PROTECTING GLOBAL HEALTH
SECURITY.
HOWEVER, RESEARCH WITH INFECTION
AGENTS ALSO PROVIDES POTENTIAL
BIOSAFETY AND BIOSECURITY RISKS.
IT IS IMPORTANT THAT WE WORK TO
ENSURE WE IDENTIFY AND MANAGE
THESE RISKS IN ORDER TO CONTINUE
TO REAP BENEFITS OF THE RESEARCH
THAT THIS PROVIDES.
U.S. POLICIES FOR THE OVERSIGHT
OF DURC ARE PART OF A
COMPREHENSIVE BIOSAFETY AND
BIOSECURITY OVERSYSTEM,
SOMETHING WE BEGAN TO DISCUSS AT
OUR LAST LISTENING SESSION.
THIS OVERSIGHT SYSTEM IS
PREDICATED ON IDENTIFYING AND
ASSESSING BENEFIT AND RISK AND
WORKING TO APPROPRIATELY
PRESERVE BENEFITS WHILE
MITIGATING RISKS.
ACHIEVING APPROPRIATE OVERSIGHT
IS A SHARED RESPONSIBILITY WHICH
IS WHY WE HAVE YOU HERE TODAY TO
CONTINUE TO HELP US MAKE SURE
WE'RE MEETING THIS GOAL.
AS MUCH AS POLICIES INVOLVE
COOPERATION ACROSS FEDERAL
INSTITUTIONS LEVELS AS WELL.
NIH AND U.S. GOVERNMENT IS
UPDATING THESE POLICIES, IT'S
JUST GOOD POLICY STEWARDSHIP TO
REMAIN EFFECTIVE IN TERMS OF
SCIENTIFIC LANDSCAPE AND
CONSIDERING HOW SOCIETY
CONSIDERS BENEFITS AND RISKS OF
THIS RESEARCH.
SO, ENGAGEMENT WITH INPUT FROM
PUBLIC AND STAKEHOLDERS ARE
CRITICAL PART OF POLICY PROCESS.
AS PART OF THESE EFFORTS WE'RE
GRATEFUL FOR THOSE HERE TODAY
AND THOSE WHO WILL JOIN US
ONLINE TO PROVIDE COMMENT TO
INFORM OUR FUTURE THIS KIND OF
RESEARCH.
SO, I WANTED TO START BY TALKING
A LITTLE BIT ABOUT THE U.S.
OVERSIGHT OF LIFE SCIENCES
RESEARCH, DURC.
INFORMED BY RECOMMENDATIONS OF
THE NSABB, MEMBERS ARE HERE
TODAY TO LISTEN TO THIS
CONVERSATION, INPUT FROM
STAKEHOLDERS AND EVENTS SUCH AS
THE ONE TODAY, U.S. GOVERNMENT
DEVELOPED AND ISSUED TWO
COMPLEMENTARY POLICIES FOR
IDENTIFICATION AND OVERSIGHT OF
LIFE SCIENCES DURC.
THESE POLICIES WERE ISSUED A
DECADE AGO, OF COURSE WE KNOW IT
TOOK MANY YEARS TO PROVIDE ALL
OF THE IMPORTANT POLICY CAVEATS
AND SCIENTIFIC BACKGROUNDS FOR
THESE POLICIES, BUT THEY ARE
COMPLEMENTARY AND WORK IN TANDEM
TOE PROMOTE CULTURE OF
RESPONSIBILITY BY REMINDING
INVOLVED PARTIES OF SHARED DUTY
TO PULL INTEGRITY OF SCIENCE AND
PREVENT MISUSE.
FIRST OF THESE TWO POLICIES
ISSUED IN 2012 IS U.S.
GOVERNMENT POLICY FOR OVERSIGHT
OF LIFE SCIENCES DURC.
THIS POLICY REALLY WORKS TO
ARTICULATE AND DEFINE THE ROLES
AND RESPONSIBILITIES OF FEDERAL
FUNDING AGENCIES, INCLUDING
REGULAR REVIEW OF RESEARCH
PORTFOLIOS, TO IDENTIFY DURC AND
APPROPRIATELY MITIGATE THOSE
RISKS.
THE SECOND ONE ISSUED IN 2014 IS
POLICY FOR INSTITUTIONAL
OVERSIGHT OF LIFE SCIENCES DURC,
THIS POLICY REQUIRES FEDERALLY
FUNDED RESEARCH INSTITUTIONS TO
ESTABLISH SYSTEM OF OVERSIGHT TO
IDENTIFY DURC AND WORK WITH
FUNDING AGENCIES TO MITIGATE
RISK AS APPROPRIATELY.
IMPORTANTLY, I WOULD BE REMISS
IF I DIDN'T ACKNOWLEDGE
ACCOMPANYING, THE U.S. WORKED
WITH MANY HERE TODAY TO DEVELOP
SHARED TOOLS AND EXPERTISE TO
AID IN IMPLEMENTATION OF
POLICIES INCLUDING COMPANION
GUIDE, CASE STUDIES, OTHER
TRAINING MATERIALS SUCH AS
VIDEOS AND BROCHURES TO HELP THE
COMMUNITY AND SOCIETY AT LARGE
TO UNDERSTAND THIS TYPE OF
RESEARCH AND BENEFITS IT
PROVIDES AS WELL APPROPRIATE
MITIGATION OF RISKS.
TOGETHER THESE TWO POLICIES
REALLY ARTICULATE THE ROLES AND
RESPONSIBILITIES OF FEDERAL
FUNDING AGENCIES, RESEARCH
INSTITUTES, AND INVESTIGATORS
FOR IDENTIFICATION AND OVERSIGHT
OF DURC.
TO PROMOTE A COLLABORATIVE
APPROACH BETWEEN FEDERAL FUNDERS
AND RESEARCH INSTITUTIONS.
THIS HAPPENED ACROSS THE
RESEARCH CONTINUUM FOR OF FROM
PROJECT CONCEPTION TO
PUBLICATION OF RESULTS AND
FINDINGS, AGAIN MUCH OF WHICH
WE'LL TALK ABOUT LATER TODAY.
BEFORE WE DIVE INTO TODAY'S
SESSIONS WE WANT TO PROVIDE
GROUND BASE CONCEPTS FOR THOSE
JOINING US OR NEW TO THIS AREA,
REMIND OURSELVES WHERE SOME OF
THESE KEY POLICY CONCEPTS
ORIGINATED FROM.
AGAIN, THINKING THROUGH SOME
HARD WORK TO HELP US CONCEIVE
ORIGINATIONS OF POLICY.
ONE DUAL USE VERSUS IS A
CRITICAL DISTINCTION, RECOGNIZED
BY MOST THAT MUCH OF LIFE
SCIENCE RESEARCH HAS SOME
POTENTIAL TO BE MISUSED.
DURC IS THE SMALL SUBSET OF
RESEARCH WITH HIGHEST POTENTIAL
OR GREATEST RISK TO BE MISUSED
TO POSE A THREAT TO PUBLIC
HEALTH OR OTHER ASPECTS OF
NATIONAL SECURITY.
THE REAL FUNDAMENTAL CHALLENGE
OF THIS IS HOW TO FACILITATE
REALIZATION OF THE BENEFITS OF
THIS RESEARCH, WHILE MITIGATING
RISKS OF MISUSE.
THE DURC POLICIES ARE SCOPED
AROUND A WELL DEFINED SUBSET OF
LIFE SCIENCES RESEARCH, THIS
UTILIZES 15 AGENTS AND TOXINS
AND SEVEN CATEGORIES OF
EXPERIMENTS, THAT WERE DESIGNED
TO COMPLEMENT EXISTING
BIOSECURITY POLICIES AND
REGULATIONS.
THIS IS REGARDING POSSESSION AND
HANDLING OF HIGH CONSEQUENCE
BIOLOGICAL AGENTS.
THE 15 AGENTS AND TOXINS ARE
REGULATED UNDER FEDERAL LAW AND
WORK IS SUBJECT TO STRICT
BIOSECURITY AND BIOSAFETY
OVERSIGHT REQUIREMENTS.
THE SEVEN CATEGORIES OF
EXPERIMENTAL EFFECTS DESCRIBE
OUTCOMES IF PRODUCED WOULD
WARRANT CAREFUL ASSESSMENT FOR
DURC, INCLUDING RESEARCH
ANTICIPATED TO ENHANCE HARMFUL
CONSEQUENCES OF AGENT OR TOXIN,
INCREASE STABILITY, TRANSMISS
BUILT, OR ABILITY TO DISSEMINATE
AGENTS OR TOXIN OR ALTER HOST
RANGE OR TROPISM OF THE TOXIN.
RESEARCH DETERMINED TO BE DURC
REQUIRES ASSESSMENT OF THE
POTENTIAL DEN FITS -- BENEFITS,
IMPLEMENTATION OF A RISK
MITIGATION PLAN, APPROPRIATE
ONGOING OVERSIGHT.
WE'RE GOING TO TALK ABOUT
ROLES AND RESPONSIBILITIES THAT
ARE SHARED AMONGST THE FEDERAL
GOVERNMENT AND INSTITUTIONS
CONDUCTING DURC.
THE DURC POLICIES APPLY TO
FEDERAL DEPARTMENTS AND AGENCIES
THAT FUND OR CONDUCT LIFE
SCIENCES RESEARCH.
THE POLICIES ALSO APPLY TO
RELEVANT RESEARCH CONDUCTED AT
ANY INSTITUTION WITHIN THE U.S.
THAT RECEIVES FEDERAL FUNDS TO
CONDUCT OR SPONSOR LIFE SCIENCES
RESEARCH, REGARDLESS OF THE
SOURCE OF FUNDING FOR A
PARTICULAR PROJECT.
IMPORTANTLY, INSTITUTIONS
OUTSIDE THE U.S. THAT RECEIVE
FEDERAL FUNDS TO CONDUCT OR
SPONSOR RESEARCH SUBJECT TO
POLICY.
NON-FEDERALLY FUNDED ENTITIES
ARE NOT SUBJECT TO THE
ADDITIONAL OVERSIGHT REQUIRED BY
DURC POLICIES, THE POLICY
STRONGLY ENCOURAGES
IMPLEMENTATION OF INTERNAL
OVERSIGHT PROCEDURES, CONSISTENT
WITH CULTURE OF SHARED
RESPONSIBILITY THAT UNDERPINS
THE OVERSIGHT OF THE DURC
FRAMEWORK.
I WON'T GO THROUGH ALL THE NEXT
SLIDE BUT SOME KEY
RESPONSIBILITIES INCLUDING
IMPLEMENT POLICIES IN THE
FRAMEWORK, ESTABLISHING
INSTITUTIONAL REVIEW ENTITY,
DESIGNATING INSTITUTIONAL
CONTACT FOR DUAL USE RESEARCH.
THE IRE IS RESPONSIBLE FOR
REVIEWING RESEARCH SUBJECT TO
POLICY, CONDUCTING RISK/BENEFIT
ASSESSMENT TO INFORM DEVELOPMENT
OF DRAFT RISK MITIGATION PLANS.
THE DESIGNATED ICDUR, RESOURCE
AND LIAISON AND ASSIST I.R. E IN
DUTIES, ENSURING STAFF ARE
TRAINED AND EDUCATED IN POLICIES
AND CONDUCT DURC IN ACCORDANCE
WITH APPROVED RISK MITIGATION
PLANS.
IN ADDITION TO REVIEWING
RESEARCH PORTFOLIOS TO IDENTIFY
DURC, FUNDING AGENCIES WORK WITH
INSTITUTIONS TO FINALIZE AND
APPROVE RISK MITIGATION PLANS.
AS I MENTIONED EARLIER, WE IN
THE FEDERAL GOVERNMENT AND AT
NIH ARE ALWAYS THINKING ABOUT
THE EFFECTIVENESS OF BIOSECURITY
POLICIES, POLICY FRAMEWORK IN
GENERAL, TO ENSURE THEY ARE
APPROPRIATELY BALANCING CRITICAL
RESEARCH ADVANCES ON MITIGATING
RISK.
BACK IN FEBRUARY THE NSABB WAS
CHARGED WITH CONDUCTING A
THOROUGH EVALUATION OF TWO
BIOSECURITY POLICY FRAMEWORKS,
FOR RESEARCH INVOLVING ENHANCED
POTENTIAL PANDEMIC PATHOGENS AND
FOR TODAY'S FOCUS DURC TO INFORM
ONGOING U.S. GOVERNMENT
BIOSECURITY POLICY EVALUATION
EFFORTS.
INFORMATION ABOUT THIS EFFORT
INCLUDING FULL CHARGE CAN BE
FOUND ON OUR WEBSITE, OFFICE OF
SCIENCE POLICY.
INCLUDING EVALUATING
EFFECTIVENESS OF POLICIES AND
IMPACT ON RESEARCH, IDENTIFYING
IMPLEMENTATION CHALLENGES, AND
THINKING ABOUT EVALUATING
EFFECTIVENESS WITH REGARD TO
PUBLICATION, PUBLIC
COMMUNICATION AND DISSEMINATION
OF DUAL USE RESEARCH
METHODOLOGIES AND RESEARCH.
SO WE'RE WORKING HERE TODAY TO
THINK AROUND WHAT THE DEFINITION
AND SCOPE OF DURC MEANS AND HOW
TO KEEP PACE WITH SCIENTIFIC
ADVANCES EVOLVING UNDERSTANDING
RISK AND BENEFITS.
IMPORTANTLY COALESCING AND
INTEGRATING POLICY AND HOW THIS
CANP APPLIED TO MITIGATE RISK
FROM RESEARCH AND BIOSAFETY AND
BIOSECURITY CONSIDERATIONS.
OUR GOALS FOR TODAY, I'M EXCITED
TO GET US STARTED, COMING
TOGETHER TO HEAR FROM
STAKEHOLDERS INCLUDING RESEARCH
INSTITUTION REPRESENTATIVES AND
BIOSECURITY POLICY EXPERTS, ALSO
ENGAGED PUBLIC WHO SIGNED UP TO
PROVIDE COMMENTS DURING TODAY'S
SESSION AS WELL AS POLICY
EXPERTS, BIOSAFETY AND
BIOSECURITY EXPERTS AND MORE.
OUR DISCUSSIONS WILL SPAN THREE
SESSIONS, FOCUSED ON SCOPE AND
DEFINITIONS OF THE DURC POLICY,
HOW THE POLICY HAS BEEN
IMPLEMENTED, WHAT WE SHOULD
THINK ABOUT FOR THE FUTURE
MOVING INTO THE NEXT DECADE.
I'D LIKE TO THANK YOU FOR
PARTICIPATING.
YOUR INPUT IS IMPORTANT TO U.S.
GOVERNMENT EFFORTS AND ONGOING
NSABB DELIBERATION AND LOOK
FORWARD TO YOUR PERSPECTIVES.
I'M PLEASED TO INTRODUCE GERALD
PARKER, COLLEGE OF VETERINARY
MEDICINE, TEXAS A & M
UNIVERSITY, CHAIR OF THE NSABB
WHO HAS AGREED TO MODERATE THE
FIRST SESSION TODAY.
WE ASK SESSION 1 PARTICIPANTS TO
TURN ON CAMERAS.
DR. PARKER, WELCOME.
I TURN THIS OVER TO YOU.
>> THANK YOU, LYRIC, FOR THE
WONDERFUL INTRODUCTION.
I WANT TO THANK THE NIH STAFF
FOR MAKING THIS STAKEHOLDER
ENGAGEMENT POLICY TODAY.
MY THANKS TO EVERYONE.
IT'S NOT EASY TO DO THESE
THINGS.
SESSION 1 IS INTENDED TO FOCUS
ON DURC POLICIES, SCOPE,
DEFINITION, EFFECTIVENESS
TOWARDS PRESERVING DUAL RESEARCH
CONCERN.
THE DURC POLICY AND SCOPE MUST
BE ALSO CONSIDERED IN THE
CONTEXT OF THE SCIENTIFIC
LANDSCAPE INCLUDING PATHOGENS
AND ADVANCES AND CONVERGENCE IN
TECHNOLOGIES AND TECHNICAL
CAPABILITIES.
IT'S IMPORTANT TO REMEMBER THIS
GOES BEYOND PUBLIC HEALTH, WE
HAVE TO CONSIDER AGRICULTURAL,
PLANTS, ANIMALS, ENVIRONMENT,
NATIONAL SECURITY AS WELL.
OVERARCHING QUESTIONS TO ADDRESS
IN SESSION 1 INCLUDE WHAT ARE
THE STRENGTHS AND WEAKNESSES OF
THE SCOPE OF DURC OVERSIGHT
POLICY IN ADDRESSING POTENTIAL
RISKS ACROSS THE LIFE SCIENCES
SPECTRUM, AS REMINDER WE JUST
HEARD ALSO CURRENT DURC POLICY
APPLIES TO RESEARCH ON 15 SELECT
AGENTS AND TOXINS.
IT DOES COVER 7 EXPERIMENTAL
CATEGORIES AND ONLY APPLIES TO
FEDERALLY FUNDED INSTITUTIONS.
THE SECOND QUESTION, ARE THERE
ALTERNATIVE APPROACHES FOR
OVERSEEING RESEARCH WITH DUAL
USE POTENTIAL THAT EFFECTIVELY
PRESERVES RESEARCH BENEFITS
WHILE EFFECTIVELY MITIGATING
RUSSIAN.
NUMBER THREE, SHOULD THE CURRENT
DEFINITIONS BE REVISITED TO
ADDRESS CONVERGENCE WITH OTHER
SCIENTIFIC DISCIPLINES AND
TECHNOLOGIES?
FOR THE PURPOSE OF SESSION 1, I
WILL NOW INTRODUCE PANELISTS TO
PROVIDE PERSPECTIVES AND ENGAGE
IN DISCUSSION ON THESE TOPICS.
I'M GERALD PARKER, JOINED BY
PANELISTS, FOLLOWED BY QUESTIONS
AND DISCUSSION WITH OTHER
PANELISTS AND NSABB MEMBERS WHO
JOINED US TODAY.
I WILL INTRODUCE ALL FOUR FIRST
IN THE ORDER THEY WILL BE
SPEAKING BEFORE ASKING EACH TO
PROVIDE THEIR OPENING REMARKS.
FIRST PANELIST IS JIM LE DUC,
RECOGNIZED LEADER IN FIELD OF
EMERGING INFECTIOUS DISEASE,
EXPERT IN BIOCONTAINMENT
LABORATORY SAFETY, LEADERSHIP
AND MANAGEMENT, DIRECTED
GALVESTON LABORATORY FOR OVER A
DECADE, CONTINUES TO SERVE AS
ADJUNCT PROFESSOR IN DEPARTMENT
OF MICROBIOLOGY AND IMMUNOLOGY.
FORMER MEMBER OF THE NATIONAL
SCIENCE ADVISORY BOARD FOR
BIOSECURITY, MEMBER OF THE
W.H.O. INTERNATIONAL HEALTH
REGULATIONS REVIEW COMMITTEE FOR
COVID-19 PANDEMIC, AND MEMBER OF
THE CONTROL AND PREVENTION BOARD
OF SCIENTIFIC COUNSELORS, AMONG
OTHER ACTIVITIES.
HIS CAREER IN GOVERNMENT, JIM
HELD A NUMBER OF LEADERSHIP
POSITIONS AT WALTER REED, CDC,
EMERGING INFECTIOUS DISEASES IN
GLOBAL HEALTH.
SECOND PANELIST IS JILL TAYLOR,
HAS BEEN SENIOR ADVISER FOR
SCIENTIFIC AFFAIRS ASSOCIATION
OF PUBLIC HEALTH LABORATORIES
SINCE OCTOBER OF 2020.
JILL IS A FORMER DIRECTOR OF
WADSWORTH CENTER, NEW YORK STATE
PUBLIC HEALTH LABORATORY, HAD
OVERSIGHT OF LABORATORY'S
RESPONSE TO COVID-19 PANDEMIC IN
NEW YORK STATE.
HER INTERESTS ARE NOVEL
FORMATIVE USE TECHNOLOGIES,
GENOMIC ANALYSIS TO IMPROVE
RESPONSE AND BRING CARE CLOSER
TO THE COMMUNITY.
THIRD IS MARIA CHAVEZ, BOARD
MEMBER, NOW PRESIDENT AT
BIOCURIOUS, ORGANIZING CLASSES
AND COMMUNITY PROJECTS FOR 11
YEARS, FOUNDING MEMBER OF OPEN
INSULIN PROJECT TO BRING LOW
COST INSULIN TO THE MARKET,
MARIA LED TWO TEAMS IN 2014 AND
2015, AND CO-LEAD OF MULTIPLE
PROJECTS, ADVOCATE FOR OPEN
SOURCE SCIENCE AND CREATION OF
MORE COMMUNITY LAB SPACES,
DEMOCRATIZING SCIENCE GLOBALLY.
SHE'S BEEN CO-ORGANIZER OF THE
BIOSUBMIT PROGRAM.
FINAL PANELIST IS DREW ENDY,
BIOENGINEERING PROFESSOR AT
STANFORD UNIVERSITY, STUDIES
SYNTHESIS IN CONTEXT OF BIOLOGY.
PAST NSABB MEMBER, CURRENTLY ON
W.H.O. ADVISORY COMMITTEE,
HELPED LAUNCH MAJORS IN
BIOENGINEERING AT THE M.I.T. AND
STANFORD, CO-FOUNDER OF IgM
COMPETITION, GLOBAL GENETICS,
ENABLING 60,000 TO PRACTICE 21ST
CENTURY BIOTECHNOLOGIES.
SESSION 1 IS SCHEDULED TO END AT
1:20.
WE'LL HEAR FROM THE FIRST
PANELIST WITHOUT FURTHER ADO.
JIM, THE VIRTUAL FLOOR IS YOURS.
>> THANK YOU, GERRY AND THANKS
TO THE ORGANIZERS.
I'D LIKE TO OPEN BY SAYING WE
HAVE A SOLID FOUNDATION ON PAST
WORK DONE BY THE NSABB AS LYRIC
MENTIONED.
I'D LIKE TO SPECIFICALLY MENTION
2016 REPORT ON RECOMMENDATIONS
FOR THE EVALUATION AND OVERSIGHT
OF PROPOSED GAIN OF FUNCTION
RESEARCH.
AND SPECIFICALLY, CALL OUT CHRIS
AND JOE WHO WILL BE JOINING US
LATER TODAY FOR THEIR
LEADERSHIP.
THIS REALLY WAS QUITE AN
EXTENSIVE EFFORT.
THAT WILL ROLL TO THE FRAMEWORK
OF GUIDING FUNDING DECISIONS FOR
PROPOSE THE RESEARCH INVOLVING
ENHANCED POTENTIAL PANDEMIC
PATHOGENS, ALSO KNOWN AS P3CO
FRAMEWORK.
THERE ARE SOME WEAKNESSES THAT
COULD BE ADDRESSED.
ONE OF THEM WE'VE ALREADY HEARD
IS THE FACT THAT THE FOUNDATION
IS BASED ON 15 PATHOGENS THAT
ARE LISTED SPECIFICALLY.
AND IT'S PRETTY CLEAR, AS GERRY
MENTIONED, WE NEED TO BE BROADER
IN CONSIDERATION OF POTENTIAL
RISKY RESEARCH THAT MIGHT
INVOLVE ANY PATHOGEN, ANIMAL AND
PLANT, THAT COULD IMPACT HUMAN
HEALTH.
I QUESTION IF THE POLICY IS
ADEQUATELY BEING IMPLEMENTED
ACROSS ALL GOVERNMENT AGENCIES.
I THINK WE COULD LOOK INTO
MAKING BROADER USE OF THIS
ACROSS ALL AGENCIES, AS LYRIC
MENTIONED, IT'S SUPPOSED TO BE
ONE OF THE REQUIREMENTS.
IN ADDITION, THE FACT THAT THIS
IS NOT EASILY IMPLEMENTED
INTERNATIONALLY, I THINK WE
COULD USE THIS EXISTING
FOUNDATION AS EXAMPLE TO OTHER
NATIONS TO DEVELOP SIMILAR
POLICIES.
IT'S FOCUSED ON SEVEN
EXPERIMENTS WE'VE HEARD ABOUT.
EXPERIMENTS THAT FOCUS ON
ENHANCING TRANSMISSIBILITY, EVEN
OF PATHOGENS WITH RELATIVELY LOW
VIRULENCE MIGHT BE OF GREATEST
CONCERN AND WE SHOULD PAY
SPECIAL ATTENTION TO THOSE.
THE CURRENT SYSTEM TARGETS
ACADEMIC AND GOVERNMENT-FUNDED
RESEARCH FACILITIES.
HOWEVER, AS WE'LL HEAR LATER
FROM MARIA AND DREW, THERE'S A
GROWING ARRAY OF POTENTIAL
PLAYERS OUTSIDE OF ACADEMIA THAT
WE NEED TO INCORPORATE INTO THIS
MORE EFFICIENTLY.
THE CURRENT POLICY, REVIEW
POLICY ITSELF, IS CUMBERSOME AND
TIME CONSUMING.
IF YOU'RE AN ASSISTANT PROFESSOR
WITH YOUR FIRST R01 PROPOSING
WORK ON THIS AND YOU HAVE TO
WAIT MONTHS FOR APPROVAL THROUGH
THE GOVERNMENT PROCESS, THIS
COULD BE VERY, VERY DETRIMENTAL
TO YOUR LONG-TERM CAREER.
AND FINALLY, THE ENTIRE POLICY
IN MY VIEW IS FOCUSED ON
TOP-DOWN GOVERNMENT OVERSIGHT.
GOING FORWARD, WE MAY WANT TO
LOOK AT ENHANCING MORE BOTTOM-UP
APPROACH THAT PLACES GREATER
RESPONSIBILITY AND TOOLS TO BOTH
INVESTIGATOR AND PARENT
ORGANIZATION THAT'S CONDUCTING
THE RESEARCH.
THIS WOULD INVOLVE RISK
ASSESSMENT OF PROPOSED RESEARCH,
AND FUNDING PROCESS.
THIS WOULD REQUIRE PERHAPS
GREATER U.S. GOVERNMENT POLICY
GUIDANCE TO EVALUATE THE RISK
AND POTENTIAL CONSEQUENCES OF
ACCIDENTAL RELEASE OF A
PATHOGEN.
FURTHER, IT DEMANDS THE P.I.
ARTICULATE IN A REALISTIC
ASSESSMENT OF THE BENEFITS OF
THE PROPOSED RESEARCH.
IT WOULD ADDRESS THE GUIDANCE
NECESSARY OF ANY INFORMATION
THAT'S GENERATED AND HAVE THE
CONSIDERATION OF COULD THIS
INFORMATION ITSELF BE
POTENTIALLY MISUSED.
IT WOULD REQUIRE A ROBUST
CONSIDERATION OF BOTH BIOSAFETY
AND BIOSECURITY STANDARDS THAT
ARE INVOLVED IN CARRYING OUT THE
RESEARCH.
AND MAKE SURE THAT THE
INDIVIDUALS CONDUCTING RESEARCH
ARE APPROPRIATELY TRAINED.
IT MIGHT ALSO INVOLVE IN-PROCESS
REVIEW OF STUDIES THAT ARE
UNDERWAY SO THERE COULD BE
ADJUSTMENTS MADE IF UNINTENDED
OR UNANTICIPATED RESULTS ARE
IDENTIFIED.
IN OUR ORGANIZATION, I'D LIKE TO
SPEAK SPECIFICALLY NOW THAT
UTMB'S APPROACH TO THIS, BECAUSE
I THINK, NATIONAL HURRICANE --
NUMBER ONE WE'RE IN A UNIQUE
POSITION WITH A BIOCONTAINMENT
LABORATORY WITH ALL LEVELS UP TO
AND INCLUDING BSL4, SO WE'VE GOT
LOTS OF OPTIONS HOW TO ADDRESS
BIOSAFETY AND BIOSECURITY ISSUE.
WE'VE HAD A WELL-ESTABLISHED
INSTITUTIONAL BIOSAFETY
COMMITTEE WHICH I THINK IS
EQUIVALENT TO INSTITUTIONAL
REVIEW ENTITY THAT LYRIC HAD
MENTIONED PREVIOUSLY.
OUR IBC IS COMPOSED OF TECHNICAL
EXPERTS, WE'RE FORTUNATE THAT
WE'VE GOT EXPERTISE IN VIRUS
DISEASE AND BACTERIAL AND
RICKETSIAL, A WIDE RANGE,
AUGMENTED BY ANIMAL RESOURCE
CENTER, INFECTIOUS DISEASE
CLINICIANS, BIOSAFETY TEAM AND
ENVIRONMENTAL HEALTH GROUP
ENGAGED, AND ALSO
REPRESENTATIVES FROM THE
COMMUNITY THAT ARE KNOWLEDGEABLE
ABOUT MEDICAL SCIENCES IN
GENERAL.
THE ENTIRE PROCESS IS BUILT
AROUND A P.I.-GENERATED NOTICE
OF USE DOCUMENT, AND THIS IS AN
EXTENSIVE DOCUMENT THAT RUNS
LITERALLY 20 PAGES LONG.
I'M HAPPY TO SHARE A TEMPLATE OF
THAT FOR ANYBODY THAT'S
INTERESTED.
BUT IT INCLUDES AN IN-DEPTH
DISCUSSION OF THE AGENT, WHETHER
OR NOT VACCINES ARE AVAILABLE,
DISCUSSION ABOUT INACTIVATION
PROCEDURES, DISINFECTANTS, THE
WASTE STREAM MANAGEMENT
CHALLENGES THAT MIGHT BE FACED.
IT GOES INTO GREAT DETAIL,
DISCUSSING EXPERIMENTAL DESIGN
AND SPECIFICALLY ADDRESSES SEVEN
EXPERIMENTS OF CONCERN FOR DUAL
USE RESEARCH.
IF ANIMALS ARE INVOLVED, IT
INVOLVES REVIEW BY VET STAFF AND
COMPLEMENTS IACUC PAPERWORK
SUBMITTED AS WELL.
IT TALKS ABOUT HOW THE PATHOGENS
THEMSELVES ARE GOING TO BE
PASSED AND PROPAGATED, IT
ADDRESSES WHETHER OR NOT VECTOR
STUDIES ARE INVOLVED INCLUDING
AEROSOL EXPOSURES.
BIOSAFETY LEVEL TO BE USED IS
PROPOSED AND REVIEWED CAREFULLY
BY THE ENVIRONMENTAL HEALTH AND
SAFETY TEAM, AND THERE'S
DOCUMENTATION THAT THE
INDIVIDUALS THAT WOULD BE
CONDUCTING THE RESEARCH HAVE
UNDERGONE APPROPRIATE TRAINING.
THERE'S DISCUSSION ABOUT PPE AND
EQUIPMENT AND INSTRUMENTATION
THAT MIGHT BE USED TO THAT COULD
GENERATE AEROSOLS, IN DEPTH
DISCUSSION OF GENETIC
MODIFICATION OR RECOMBINANT WORK
THAT WOULD BE ADDRESSED.
ALL OF THIS FORCES THE P.I. TO
DO THEIR -- TO CONDUCT THEIR OWN
REALLY INTENSIVE RISK ASSESSMENT
PRIOR TO STARTING ANY
EXPERIMENT, AND ENSURES
EVERYTHING'S ALREADY IN PLACE TO
SAFELY CONDUCT THE STUDIES THAT
ARE BEING PROPOSED.
IT ALLOWS CRITICAL EVALUATION BY
EXPERTS KNOWLEDGEABLE IN THE
FIELD BUT INDEPENDENT OF THIS
PARTICULAR RESEARCH ACTIVITIES.
AND THEY, AGAIN, MAY RECOMMEND
THAT ON AS THE EXPERIMENTS
UNFOLD, THEY MAY WANT TO LOOK AT
RESULTS THAT ARE GENERATED THAT
COULD RESULT IN SOME
UNANTICIPATED RESULTS.
AND IT ENSURES THE APPROPRIATE
LEVEL OF BIOCONTAINMENT IS GOING
TO BE USED.
THIS SYSTEM WORKS QUITE WELL FOR
US.
HOWEVER, IT'S BUILT, AGAIN, ON
ACADEMIC MODEL AND WE'RE
FORTUNATE THAT WE HAVE ADEQUATE
BIOCONTAINMENT AVAILABLE TO US.
BUT WE'LL HEAR LATER FROM DREW
AND MARIA THAT OTHER SITUATIONS
EXIST WHERE POTENTIALLY RISKY
RESEARCH MAY BE CONTEMPLATED,
BUT BY ORGANIZATIONS THAT MAY
LACK EITHER PERSONNEL EXPERTISE
TO HAVE THEIR OWN COMPREHENSIVE
IBC OR ACCESS TO APPROPRIATE
BIOCONTAINMENT LEVELS.
SO POSSIBLE SOLUTION WE MAY WANT
TO TALK ABOUT IS HOW THE
GOVERNMENT MIGHT MORE EXPLICITLY
PROVIDE DIRECTION ON THE RISKS
TO BE CONSIDERED IN REVIEW OF
DURC PROPOSALS.
AND I KNOW THERE'S COURSE
CONTENT AVAILABLE BUT PERHAPS
THIS WOULD BE EXPANDED AS WELL.
ONE OF THE IDEAS WE MIGHT
CONSIDER IS THE CONCEPT OF
CONTRACT INSTITUTIONAL BIOSAFETY
COMMITTEE, THAT WOULD REVIEW
PROPOSALS FOR ORGANIZATIONS THAT
LACK EXPERTISE TO SUSTAIN THEIR
OWN IBC.
AND FINALLY, THE U.S.
GOVERNMENT'S INVESTED ABOUT A
BILLION DOLLARS IN THE
CONSTRUCTION OF REGIONAL AND
NATIONAL BIOCONTAINMENT
LABORATORIES ON ACADEMIC
CAMPUSES.
WE COULD EXPLORE HOW THIS
RESOURCE MIGHT BE MORE
EFFICIENTLY USED TO MAKE
BIOCONTAINMENT SPACE AVAILABLE
FOR THOSE INVESTIGATORS THAT
LACK SUCH ACCESS.
THERE WILL BE SEVERAL QUESTIONS
THAT INVOLVE THAT, INCLUDING
FINANCING, TRAINING
DOCUMENTATION AND A HOST OF
OTHERS I WILL NOT GO INTO NOW
BUT I THINK OVERALL BY LOOKING
AT THIS PROCESS, WE MIGHT
ENHANCE OUR ABILITY TO ADDRESS
THE QUESTIONS POSED.
WE IN PLACE A WELL-ESTABLISHED
IACUC SYSTEM THAT ADDRESSES
LABORATORY ANIMAL STUDIES AND
HUMAN RESEARCH PROCESS THROUGH
THE IRBs.
I THINK WE OUGHT TO CONSIDER
MAKING THE INSTITUTIONAL
BIOSAFETY COMMITTEES EQUIVALENT
TO THESE ALREADY ESTABLISHED
ORGANIZATIONS, AND THROUGH THAT
PROCESS WE MIGHT ESTABLISH A
MORE RIGOROUS BOTTOM-UP REVIEW
PROCESS THAT COULD AVOID
STARTING RISK OF RESEARCH AND
REDUCE THE NEED FOR DUAL USE
RESEARCH REVIEW BEYOND
INSTITUTIONAL LEVEL.
SO WITH THAT LET ME STOP.
THANK YOU.
>> THANK YOU.
YOU PROVIDED A LOT OF THINGS FOR
US TO THINK ABOUT AND SOME
VERY -- SOLUTIONS THAT PROBABLY
ARE GRASPED.
A COUPLE QUALIFY THINGS, ONE
THING THAT RESONATED,
BIOCONTAINMENT INFRASTRUCTURE,
MORE EFFECTIVE WAY, MAKE SURE
IT'S FINANCED EFFECTIVELY TOO
BUT TRANSMISSION, YOU MENTIONED
WE SHOULD PAY MORE ATTENTION TO
TRANSMISSION AS A CATEGORY,
POST-TROPISM?
>> I WAS THINKING MORE IN TERMS
OF ANY STUDIES THAT WERE BEING
UNDERTAKEN IN THE LABORATORY.
FOR EXAMPLE, WE DO A LOT OF
VECTOR-BORNE DISEASE STUDIES
WHERE WE HAVE TRANSMISSION BY
ARTHROPODS, TICKS OR MOSQUITOES
OR WHATEVER.
ALSO WE HAVE A ROBUST AEROSOL
EXPOSURE CAPABILITY.
SO THESE ARE THE KIND OF THINGS
I WAS MOST CONCERNED ABOUT.
CLEARLY, IT GOES BEYOND THAT.
>> THANKS, JIM.
NEXT SPEAKER IS JILL TAYLOR, THE
VIRTUAL FLOOR IS YOURS.
>> THANK YOU VERY MUCH, GERRY,
I'D LIKE TO THANK THE NIH AND
NSABB FOR THE OPPORTUNITY TO
SPEAK TO YOU TODAY.
NEXT SLIDE PLEASE.
I NEED TO MAKE A DISCLAIMER THAT
THE POSITION THAT I'M GOING TO
TAKE IS MY OWN POSITION, AS A
LIFELONG PUBLIC HEALTH
SCIENTIST, AND TRAINED
VIROLOGIST.
I WORK FOR ASSOCIATION OF PUBLIC
HEALTH LAB AND I HAVE ASKED MY
COLLEAGUES THERE TO CONTRIBUTE
TO MY THOUGHTS BUT IT HAS NOT
BEEN APPROVED BY THE BOARD OR
MEMBERSHIP OF THE ASSOCIATION SO
I NEED TO MAKE THAT DISCLAIMER.
I HAVE TWO POSITIONS I'M GOING
TO PROPOSE.
AND I'M COMING FROM THE
PERSPECTIVE OF PUBLIC HEALTH
SCIENTIST, HAVING GONE THROUGH
THE EARLY STAGES OF THE CURRENT
PANDEMIC, ALSO EXPERIENCING THE
MONKEYPOX OUTBREAK THAT WE'RE
NOW IN THE EARLY STAGES OF.
AND SO MY POSITION IS GOING TO
BE BASED ON THE RISK MITIGATION
PORTION OF THE DURC POLICY.
THEN WILL TAKE TWO POSITIONS
WHICH I'LL EXPLAIN IN LATER
SLIDES, ONE WE SHOULD MOVE
BEYOND CONSIDERING AND
RESPONDING TO BIOLOGICAL THREATS
IN DIFFERENT WAYS, BASED ON
ORIGIN, SECOND POSITION I WILL
TAKE IS THAT WE'RE NOT
ADEQUATELY ADDRESSING MITIGATION
OF RISK ASPECTS OF OUR OVERSIGHT
POLICY.
CAN WE GO TO THE NEXT SLIDE
PLEASE?
I THOUGHT MY BEST APPROACH WAS
JUST TO SPECIFICALLY ANSWER THE
QUESTIONS THAT WERE RAISED AND
THEN I WILL GO BEYOND THAT WITH
YOUR PERMISSION.
SO IN THE FIRST QUESTION, MY
REVIEW OF THE ADMINISTRATIVE AND
PRACTICAL PROCESSES IN THE DURC
POLICY SEEM APPROPRIATE.
AND JIM HAS MADE A CLEAR CASE
FOR ADDRESSING SOME GAPS THAT
CURRENTLY ARE IN THAT
ADMINISTRATIVE POLICY AND THESE
SEEM LIKE VERY GOOD IDEAS.
HOWEVER, I BELIEVE THE CURRENT
SCOPE OF THOSE IS TOO NARROW,
BEYOND THE 15 AGENTS AND 7
EXPERIMENTAL TYPES THAT WE
SHOULD LOOK AT THAT AND MAKE IT
BROADER BECAUSE I THINK THAT
POLICY IS BASED ON WHAT WE KNOW
NOW RATHER THAN WHAT IS LIKELY
TO BE POSSIBLE.
AND I THINK THAT'S A RISK THAT
NEEDS TO BE ADDRESSED.
NEXT SLIDE PLEASE.
QUESTION 2, I BELIEVE OUR
OVERSIGHT OF RESEARCH AND
TECHNOLOGY DEVELOPMENTS
INCLUDING SYNTHETIC BIOLOGY
WHICH WILL BE ADDRESSED LATER,
ANY OF THESE RESEARCHERS THAT DO
HAVE A DUAL USE POTENTIAL OR ARE
DURC SHOULD BE AUGMENTED BY
USING NEW FORECASTING,
IDENTIFICATION, SURVEILLANCE
TECHNOLOGIES TO DEVELOP A LIVING
LIST, NOT A STATIC LIST,
ADDRESSING BIOSAFETY AND
BIOSECURITY CONCERNS AND
ENHANCES MITIGATION.
NEXT SLIDE PLEASE.
SO, THE QUESTION 3, YES, I DO
THINK THAT THE DURC DEFINITION
AND OVERSIGHT APPROACH SHOULD BE
REVISITED.
AS A CITIZEN AND AS A PUBLIC
HEALTH SCIENTIST, I THINK THAT
TAKING INTO ACCOUNT THE HUMAN
SOCIETAL AND FINANCIAL COST OF
THE COVID-19 PANDEMIC REQUIRES
US TO REVIEW THE CURRENT
DEFINITION AND APPROACH AND I
CONGRATULATE NIH AND NSABB FOR
DOING THAT AS PART OF THIS
PROCESS.
I THINK THAT ALSO WE NEED TO AS
YOU'RE DOING CONSIDER ADVANCES
IN SYNTHETIC BIOLOGY WHICH WERE
NOT FULLY ENVISAGED WHEN THE
DURC PROCESS WAS IMPLEMENTED.
WE NEED TO LOOK AT IMPROVED
MITIGATION POTENTIAL OF USING
PATH GENERAL AGNOSTIC,
REGARDLESS OF ORIGIN.
HERE IS MY OVERALL PROPOSAL TO
DEVELOP A MORE COMPREHENSIVE
APPROACH TO DETECTION AND
MITIGATION OF BIOLOGICAL
THREATS, WHETHER NATURAL EVENT
SUCH AS ZOONOTIC, AN ACCIDENTAL
RELEASE FROM LABORATORY WHICH
CAN HAPPEN, THOUGH WE'RE TAKING
GREAT MEASURES TO PREVENT THAT,
OR AN ENGINEERED PATHOGEN WHICH
MAYBE HAD A TERRORIST ORIGIN OR
IN FACT UNINTENDED ORIGIN.
NEXT SLIDE PLEASE.
SO, I THINK THIS CAN BE DONE IN
STAGES.
IT'S A LOT TO CONSIDER BUT I
THINK IT CAN BE DONE IN STAGES.
WE FIRST BEING WE NEED TO REVIEW
THE CURRENT POLICY, BASED ON
PANDEMIC EXPERIENCE, AND WHAT WE
LEARNED FROM THAT.
IT'S BASED ON EVERYTHING I HAVE
READ.
IT SEEMS THE CONSENSUS IS THAT
THIS WAS A NATURAL ZOONOTIC
EVENT.
THE RELEASE FROM A LABORATORY
HAS NOT BEEN COMPLETELY
ELIMINATED BUT GIVEN A LOWER
CHANCE OF HAVING HAPPENED THAT
WAY.
BUT I DO THINK WE SHOULD LEARN
FROM THE PANDEMIC EXPERIENCE.
I THINK THAT WHAT I'M PROPOSING
SHOULD BE ADDED TO THE CURRENT
POLICY, NOT TO REPLACE THE
CURRENT POLICY.
SO WE SHOULD RETAIN THE
CAPABILITY TO OVERSEE DURC
RESEARCH, P3 RESEARCH, ON HIGH
PRIORITY LIST PATHOGENS AND
CONSTRUCTS.
BUT WE NEED TO MODERNIZE
LABORATORY DETECTION METHODS FOR
HIGH PRIORITY PATHOGENS, THESE
ARE LABORATORY RESPONSE METHODS
WHICH WERE DEVELOPED EARLY IN
THE 2000s, AND BASED ON
OUTDATED METHODS, OUTDATED
TARGETED METHODS.
WE SHOULD USE THE INFORMATION
GAINED FROM THE NEW CDC TO ADD
NEW THREAT AGENTS BASED ON
FINDINGS, AND EMERGING PATHOGENS
TO CREATE A LIVING LIST OF
TARGETS.
WE SHOULD DEFINITELY ENGAGE WITH
AND CONSULT WITH THE SYNTHETIC
BIOLOGY COMMUNITY TO BETTER
UNDERSTAND THE POTENTIAL RISKS
OF THEIR WORK.
THIS IS SOMETHING THAT I HOPE
MARIA WILL ADDRESS AND DREW WILL
ADDRESS ABOUT HOW BEST TO DO
THAT.
NEXT SLIDE PLEASE.
WE SHOULD MOVE AWAY FROM
RELIANCE ON TARGETED ASSAYS.
MOST OF THE METHODS FOR SELECT
AGENTS ARE BASED ON PCR TARGETED
PCR ASSAYS SO YOU FIND WHAT
YOU'RE LOOKING FOR AND THAT'S
ALL YOU FIND.
WE SHOULD RESEARCH PATHOGEN
AGNOSTIC APPROACHES SUCH AS
METAGENOMIC EXPENSES IN COMPLEX
SAMPLE TIMES SUCH AS WASTE
WATER, THIS APPROACH HAS BEEN
WELL DEVELOPED DURING THE COVID
CAMPAIGN, ACADEMIC CENTERS HAVE
BEEN VERY MUCH INVOLVED IN THIS,
THE METAGENOMIC APPROACH IS
EARLY BUT HAS GREAT POTENTIAL AS
WELL AS WE NEED TO DO RESEARCH
IN BIOINFORMATIC APPROACHES THAT
ARE NECESSARY TO UNDERSTAND
METAGENOMIC SEQUENCING AND MAKE
USE OF IT.
WE NEED TO GET INTO THE
COMMUNITY AND DEVELOP RAPID
ADAPTABLE AND SENSITIVE
SCREENING PLATFORMS FOR MASS
USAGE AT POINTS OF ENTRY LIKE
AIRPORTS, URGENT CARE CENTERS,
EMERGENCY ROOMS, POINTS OF
OUTBREAK, SO IF THERE IS A LEAK
FROM A LABORATORY, IF THERE'S AN
INCOMING PATHOGEN, WE NEED TO BE
ABLE TO HAVE A VERY BROAD
POPULATION-BASED APPROACH TO
FIND THE LIMITS OF THE OUTBREAK.
WE NEED TO INVEST AT ALL LEVELS
IN GLOBAL, NATIONAL, REGIONAL
AND LOCAL SURVEILLANCE PROGRAMS
TO PROVIDE AN EARLY WARNING OF
THE DEVELOPMENT OR ENTRY OF NEW
PATHOGENS.
AND MY LAST SLIDE PLEASE.
I THINK WE NEED TO REIMAGINE OUR
PUBLIC HEALTH SYSTEM.
HAVING COME THROUGH -- WELL,
WE'RE NOT THROUGH THE PANDEMIC,
LOOKING AT WHAT WENT WRONG, WHAT
WENT RIGHT, EARLY STAGES OF THE
MONKEYPOX STAGES, GETTING A LOT
OF CRITICISM.
WE NEED TO UNDERSTAND PUBLIC
HEALTH IS EVERYONE'S
RESPONSIBILITY AND WE NEED TO
ENGAGE MULTIPLE SECTORS OF THE
SCIENTIFIC COMMUNITY, COMMERCIAL
LABS, CLINICAL HOSPITAL LABS,
MANUFACTURERS, ACADEMIC RESEARCH
CENTERS, IN MITIGATING RISK
AGAINST BIOLOGICAL THREATS.
I MENTIONED THE WASTE WATER
SURVEILLANCE WHICH WAS RAPIDLY
ADDRESSED IN ACADEMIC
COMMUNITIES AND WHERE I THINK
THEY MADE GOOD PROGRESS.
SO I THINK THAT WE NEED AS A
SCIENTIFIC COMMUNITY TO THINK
ABOUT PUBLIC HEALTH SYSTEM AND
CREATE A SYSTEM WHICH IS WELL
COORDINATED AND WHERE ROLES ARE
UNDERSTOOD AND ADDRESSED.
AND THAT'S MY LAST THOUGHT.
THANK YOU, GERRY.
>> JILL, THANK YOU.
ONE QUICK FOLLOW-UP, I AGREE,
SOME OF THE SEQUENCING CAPACITY
THAT WAS RAPIDLY ESTABLISHED,
WASTE WATER ANALYSIS WHICH IS
PHENOMENAL, A LOT OF IT
UNIVERSITY BASED, ONE THING THAT
WORRIES ME HOW ARE WE GOING TO
SUSTAIN THAT?
QUICK THOUGHTS ON THAT.
>> SO, MY FEELING IS SEQUENCING
AND METAGENOMIC SEQUENCING IS
GOING TO BECOME THE NEW GOLD
STANDARD.
AT THE MOMENT IT'S REALTIME PCR.
WE'RE RAPIDLY MOVING BEYOND THAT
TO THE FIRST LEVEL DONE AS
SAMPLE COMES TO A LAB, AT LEAST
PUBLIC HEALTH AND ACADEMIC LABS,
MAYBE NOT COMMERCIAL LABS, THIS
IS GOING TO BE METAGENOMIC
QUEENING AND I DON'T THINK THE
FUTURE IS THOROUGH.
>> ME TOO.
THANK YOU.
THOUGHTS ABOUT REIMAGINING THE
PUBLIC HEALTH SYSTEM, YOUR FINAL
THOUGHT.
THIRD SPEAKER IS MARIA CHAVEZ.
MARIA, THE VIRTUAL FLOOR IS
YOURS.
>> GREAT.
WELL, THANK YOU FOR HAVING ME
TODAY.
I'M REALLY THANKFUL TO BE PART
OF THIS EVENT.
I'M NOT THE TYPICAL SPEAKER AT
DURC SESSIONS BUT I WAS HOPING
TO BRING A NEW PERSPECTIVE.
I TALK AT A LOT OF BIOSECURITY
AND BIOSAFETY EVENTS, GENERALLY
ADDRESSING CONCERNS ABOUT THE
SAFETY OF COMMUNITY LABS.
JUST TO GIVE HISTORY ON THIS,
COMMUNITY SCIENCE LABS AND DOI
BIOLOGY LABS IN AND OF
THEMSELVES ARE NOT IN THE SCOPE
OF DURC AS BY AND LARGE
FACILITIES THAT ARE DOING THIS
AND PEOPLE DOING THIS ARE
WORKING IN BSL 1 FACILITIES.
THERE ARE A FEW SUCH AS MY LAB
BIOCURIOUS THAT ARE BSL 1 WITH
MAMMALIAN TISSUE CULTURING ON
SITE.
LABS SUCH AS MYSELF WE DO HAVE
INTERNAL REVIEW PROCESS FOR
EXPERIMENTS AND ORGANISMS BUT DO
NOT HANDLE SELECT AGENTS OR
CONDUCT GAIN OF FUNCTION
RESEARCH BUT WANT TO GIVE MY
PERSPECTIVE ON DURC GUIDELINES
AND THE GROWING BIOTECH AND LIFE
SCIENCE MOVEMENT.
SO, FOR THE LAST 12 YEARS WE'VE
SEEN A BIG SPREAD OF THE GLOBAL
COMMUNITY, GROWN FROM TWO LABS
IN THE U.S. INITIALLY
BIOCURIOUS, GEN SPACE IN
BROOKLYN, TO INTERNATIONAL
CONFERENCES LIKE THE GLOBAL
COMMUNITY BIOSUMMIT, WHICH HAS
BEEN GOING ON FOR SIX YEARS.
LAST YEAR WE HAD 650 VIRTUAL
ATTENDEES FROM 62 COUNTRIES.
WE HAVE ONE OF THE MOST BROAD
REACHES TO COUNTRIES IN THE
WORLD OF ANY CONFERENCE I'VE
SEEN.
EYE MONKS -- AMONGST THE TRACKS
WE INCLUDE BIOSECURITY AND
BIOETHICS.
WE'VE BEEN ASKING WITH LIFE
SCIENCES AND COMMUNITY LABS ARE
WE A MOVEMENT FOR CHANGE IN OUR
COMMUNITIES?
ALONG THESE LINES OUR GLOBAL
COMMUNITY WORKED TO NOT JUST
HOST CONFERENCES BUT CREATE
SHARED PURPOSE IN THE THIRD YEAR
OF THE CONFERENCE WE CREATED A
SHARED PURPOSE STATEMENT.
AND BASICALLY OUR GLOBAL
COMMUNITY IS LOOKING TO
FUNDAMENTALLY TRANSFORM LIFE
SCIENCE, DEMOCRATIZE BIOTECH,
INSPIRE CREATIVITY, ORGANIZE
LIFE SCIENCE CHANGEMAKERS AND
BIOENTHUSIASTS, BUILD A GLOBAL
NETWORK, CREATE ACCESSIBLE
COMMONS OF RESOURCES, LAUNCH
LABS, ENABLE LOCAL EDUCATORS.
THE YEAR AFTER WE CO-DEVELOPED
THAT SHARED STATEMENT OF
PURPOSE, OUR GLOBAL COMMUNITY
DID ACTUALLY DEVELOP 12 SHARED
ETHICS POINTS.
A SUBGROUP OF OUR COMMUNITY
WORKING ON A GRANT FROM OPEN
PHILANTHROPY FOUNDATION WITH
ASSISTANCE WAS ABLE TO CREATE
250-PAGE COMMUNITY LAB SPECIFIC
BIOSAFETY MANUAL TO ADDRESS
UNIQUE NEEDS OF LABS, WHICH ARE
DIFFERENT FROM OTHERS BECAUSE
YOU'RE WORKING WITH THE GENERAL
PUBLIC, DON'T NECESSARILY HAVE A
SINGLE P.I.
YOU DON'T NECESSARILY HAVE, YOU
KNOW, AN INSTITUTIONAL REVIEW
BOARD TO LEAN ON.
LEANING INTO THE EXAMPLES SET BY
IgM HUMAN PRACTICES GROUP I
THINK THE BIGGEST THING THAT I
TAKE OUT OF DURC IS CULTURE OF
RESPONSIBILITY, WHAT WE HEARD
BEFORE TODAY IS ABOUT THIS KIND
OF BOTTOM-UP IDEA OF BUILDING A
CULTURE OF RESPONSIBILITY AND
INSTEAD OF RELYING ON TOP-DOWN
APPROACH.
I THINK THIS IS REALLY IMPORTANT
THAT WE TALK ABOUT THE CULTURE
OF RESPONSIBILITY AND GROWTH OF
BIOTECH, BECAUSE RISKS FROM LIFE
SCIENCE EXPAND AS IT GROWS.
AND WHAT WE'VE SEEN IS THAT
THESE GUIDELINES AND THINGS WERE
PRIMARILY IN THE REALM OF
INSTITUTIONS LIKE UNIVERSITIES,
PHARMA, AG, AND NOW LIVE
SCIENCE, BIOTECHING ME
MAINSTREAMED, BECOMING A
MANUFACTURING TOOL FOR
INDUSTRIES AND SECTORS AND
SYNTHETIC BIOLOGY IS A NORMAL
PART OF HIGH SCHOOL AND WHAT
RISKS DO THOSE BRING AS WELL AS
I THINK OPPORTUNITIES.
YOU KNOW, AS THIS GROWTH OF
BIOTECH EXPANDS EXPONENTIALLY
EVERY YEAR INTERNATIONALLY
ESPECIALLY, RISKS FROM DUAL USE
RESEARCH OF CONCERN INCREASE.
IT'S MY OPINION THE GREATEST
STRENGTH WITH CURRENT DURC
REGULATIONS IS THAT BY
DEVELOPING REGULATIONS, BY
STARTING THE CONVERSATION
NATIONALLY, WE'RE LEADING
INTERNATIONALLY IN BIOSECURITY
POLICIES INCLUDING DURC AND WE
OFTEN SET THE STANDARDS FOR
REGULATORY FRAMEWORKS FOR OTHERS
TO USE, BECAUSE THEY DON'T HAVE
TO DEVELOP IT.
THEY CAN LOOK TO US FOR
GUIDANCE.
SO AS MORE COUNTRIES EXPAND
SCOPE OF LIE SCIENCE RESEARCH I
WOULD ASK WHAT ARE WE ACTUALLY
DOING AND WHAT COMMITMENT ARE WE
MAKING TO EXPAND AND EDUCATE
ABOUT HOW TO IMPLEMENT
GUIDELINES AND REGULATIONS.
SO, THIS IS STUFF THAT'S BEEN
HAPPENING, ARE WE REQUIRING THIS
KIND OF BOTTOM-UP APPROACH MORE
GENERALLY.
I THINK THE BIGGEST WEAKNESS
WITH CURRENT DURC POLICY IS
THATPREDICATED ON AN IDEA IT
APPLIES TO PEOPLE THAT RECEIVE
FEDERAL FUNDING.
AGAIN, I THINK THAT WAS TRUE,
BUT IT'S LESS AND LESS SO
BECOMING TRUE.
BIOTECH IS TAKING PLACE LESS SO
IN INSTITUTIONS AND SO
INSTITUTIONS THAT DON'T HAVE ANY
SORT OF FEDERAL OVERSIGHT AND
TAKE ANY FEDERAL DOLLARS WOULD
NOT COME UNDER DURC.
HOWEVER, I DO THINK THAT THE
CURRENT FSAP DOES LIMIT SELECT
AGENTS, SO THAT DOES GIVE
PROTECTION AS FAR AS WHO IS
WORKING WITH SELECT AGENTS BUT
DURC DOES NOT APPLY TO THOSE
WHO, AGAIN, AREN'T WORKING WITH
FEDERALLY FUNDED INSTITUTIONS.
WE NEED TO THINK ABOUT HOW TO
EXPAND THAT LIST AND HOW TO LOOK
AT WHO WE ASSUME THESE POLICIES
AFFECT.
I UNDERSTAND THAT, YOU KNOW, THE
WAY THE POLICY WAS IMPLEMENTED
IT REALLY DID MAKE SENSE TO
START WITH WHAT YOU CAN CONTROL
AND AS A FEDERAL AGENCY YOU CAN
CONTROL WHO YOU GIVE MONEY TO.
BUT AS FAR AS EXPANDING IT WE
NEED TO THINK ABOUT WHERE IS THE
RESEARCH HAPPENING, AND IS THE
RESEARCH HAPPENING OUTSIDE OF
FEDERALLY FUNDED INSTITUTIONS.
AS FAR AS THE 15 AGENTS AND
TOXINS, I AGREE WITH WHAT
EVERYONE SAID BEFORE AND WOULD
ASK IS THE POLICY CURRENTLY
ROBUST ENOUGH TO ADAPT TO NEW
IDENTIFIED THREATS.
I THINK ROLLING OUT INITIAL
POLICY WITH 15 IDENTIFIED
THREATS WITH SEVEN IDENTIFIED
EXPERIMENTS WAS GREAT, BECAUSE
IT GAVE A MANAGEABLE AMOUNT OF
SUBSETS FOR DIFFERENT AGENCIES
TO TAKE UP.
THE QUESTION IS NOW THAT THIS
HAS BEEN AROUND FOR MANY YEARS
HOW CAN YOU EXPAND IT.
IS THERE A SUBSET OF DURC THAT
COULD BE APPLIED TO THE 55 OTHER
AGENTS ON THE SELECT AGENTS
LIST?
IS THERE A FRAMEWORK THAT CAN
HELP US WORKING WITH ALL THOSE
SELECT AGENTS?
BUT, AGAIN, I'M GOING TO LEAN
BACK ON CREATING THAT CULTURE OF
RESPONSIBILITY BOTTOM-UP.
THE IDEA OF THE RESPONSIBILITY
HAS RELIED ON INSTITUTIONAL
REVIEW BOARDS, ON FUNDING
SOURCES, PUTTING PRESSURE FROM
THE TOP DOWN.
BUT I THINK THAT ONE OF THE NICE
THINGS ABOUT BIOTECH IS IN
REGARDS TO OTHER TECHNOLOGY
WE'VE REALLY WORKED TO AS A
RESULT INDICATE A CULTURE OF
RESPONSIBILITY THAT NEEDS TO
CONTINUE.
ONE THING I WOULD IDENTIFY AS AN
AREA FOR EVALUATION IS CYBER
SECTOR.
AND PREDICTIVE ANALYTICS.
I THINK A LOT OF WHAT WE THINK
ABOUT WORKING WITH SELECT
AGENTS, WITH DURC POLICIES, IS
PHYSICAL ACCESS TO THESE AND I
THINK WHEN WE LOOK AT THE SCALE
OF PREDICTIVE ANALYTICS, ALPHA
FOLD, BIOINFORMATICS IN GENERAL
HOW MUCH OF A RISK FOR DURC DO
THESE TYPE OF TECHNOLOGIES GIVE
US AND HOW MUCH DO THEY COME
UNDER DURC REVIEW?
AND SO I THINK A LOOK AT NEW
TECHNOLOGIES THAT ARE COMING UP
AND HOW THEY CAN BE APPLIED TO
BOTH IDENTIFYING DURC RISK AREAS
BUT THEMSELVES ARE DUAL USE
RESEARCHES THAT CAN CREATE
KNOWLEDGE THAT WE WOULD NEED TO
THINK ABOUT HOW DO WE REGULATE.
SO, OVERALL, I WANT TO LEAN INTO
THIS IDEA THAT GLOBAL EDUCATION
AND LIFE SCIENCES NEEDS TO BE A
REAL FOCUS AREA AND WE NEED TO
BUILD UP THAT CULTURE OF
RESPONSIBILITY, NOT JUST
NATIONALLY BUT GLOBALLY.
AND I THINK THAT THERE ARE SO
MANY EMERGING COMMUNITIES AROUND
THE WORLD THAT AREN'T IDENTIFIED
FEDERALLY, A LOT OF WHICH I DO
HAVE ACCESS TO.
I'D LIKE TO HAVE CONVERSATIONS
ABOUT HOW CAN WE DO THINGS
SIMILAR TO WHAT WE DID WITH ABSA
INTERNATIONAL, CREATING
BIOSAFETY MANUAL, CREATING THE
CULTURE OF RESPONSIBILITY EARLY,
HAVING CONVERSATIONS WITH
RESEARCHERS EARLY IN CAREER AS
WELL AS WITH THE FEDERAL
INSTITUTIONS OF OTHER NATIONS.
AND THERE IS A LOT HAPPENING
RIGHT NOW, ESPECIALLY IN LATIN
AMERICA AND AFRICA AROUND
WANTING TO GROW THEIR ECONOMIES
WITH BIOTECH.
IT'S NEVER TOO EARLY TO HAVE
THESE CONVERSATIONS WITH THESE
ACTORS.
THAT'S WHAT I HAVE TO SAY.
>> THANK YOU VERY MUCH.
AGAIN, A WONDERFUL PRESENTATION,
GIVING US A LOT TO THINK ABOUT.
ONE QUICK QUESTION, HOW BEST
WOULD YOU SEE -- WHAT WOULD YOU
SAY TO THE FEDERAL GOVERNMENT,
BRINGING THE COMMUNITY INTO THE
CONVERSATIONS.
YOU MENTIONED EDUCATION,
STARTING EARLY, CULTURE OF
RESPONSIBILITY.
SO, THE SINGLE MOST THING TO
MAKE SURE THE DYI COMMUNITY IS
BROUGHT IN.
>> YEAH, I THINK WE NEED TO
FIGURE OUT HOW TO BUILD INROADS
AND HAVE THE CONVERSATIONS
BECAUSE OUR COMMUNITY HAS VERY
PROACTIVELY SHOWN A WILLINGNESS
TO CREATE THIS CULTURE
ORGANICALLY WITH OUR SHARED
STATEMENT OF PURPOSE, WITH
ETHICS PRACTICES, WE HAVE A
SUBGROUP THAT'S MEETING THAT'S
LOOKING AT THINGS LIKE CREATING
OUR OWN INSTITUTIONAL REVIEW
BOARD NATIONALLY FOR DIY , WHAT
IS THE PURPOSE OF IRB AND CREATE
IRB SUPPORT AND I THINK IT'S NOT
JUST DIY, I THINK THIS IS
SOMETHING TO THINK ABOUT WITH
STARTUPS AND GROUPS WORKING
OUTSIDE INSTITUTIONS, I STRADDLE
BOTH, DIY AND START-UP WORLD,
BUT WHO CAN BUILD BRIDGES AND
HOW TO START THE CONVERSATIONS.
I THINK I THANK YOU FOR
WELCOMING ME INTO THIS
CONVERSATION BECAUSE THIS IS HOW
IT STARTS IS BRINGING
STAKEHOLDERS IN AND ADDITIONALLY
HAVING US INVITE YOU TO OUR
CONFERENCES AND GETTING THE
CONVERSATIONS GOING.
>> VERY GOOD.
THANK YOU VERY MUCH.
OUR FINAL PANELIST IS DREW ENDY.
DREW, YOU'VE GOT THE VIRTUAL
FLOOR.
>> THANKS SO MUCH.
WOULD YOU LIKE ME TO GO FOR TEN
MINUTES OR FIVE MINUTES TO
PRESERVE TIME FOR DISCUSSION?
>> YES, WE'VE EATEN INTO THE
TIME A LITTLE BIT.
FIVE TO EIGHT MINUTES, BUT MAKE
SURE YOU SAY WHAT YOU WANT TO
SAY.
>> THANKS VERY MUCH.
GRATEFUL TO FOLLOW JIM, JILL,
MARIA.
MARIA, I EXPRESS MY GRATITUDE.
WHEN STANFORD CAMPUS SHUT DOWN
FOR RESEARCH AND WE HAD IDEAS
FOR COVID DIAGNOSTICS, ABLE TO
ACCESS COMMUNITY BIOLABS YOU AND
YOUR COLLEAGUES SET UP TO
ADVANCE THEIR RESEARCH.
COMPLEMENTING THE COMMENTS
OFFERED, I WANT TO GIVE A
DIVERSITY OF PERSPECTIVES ON
WHAT I SEE HAPPENING.
DURC STARTS WITH RESEARCH, THE
WORLD IS INCREASINGLY RESEARCH
IN PRACTICE.
DUAL USE PRACTICE.
MANY PEOPLE DEPLOYING
BIOTECHNOLOGIES ARE NOT
TECHNICALLY DOING RESEARCH, JUST
TRYING TO DO SOMETHING, SO THE
PRACTICE.
SECOND COMMENT QUICKLY, DURC 2.
0, DURC PLUS, PLUS, DNA
SCREENING, HAVING DISTANCE FROM
WORK OF NSABB AND COMING BACK,
PREPPING FOR TODAY, THIS IS
REALLY COMPLICATED.
AND IT'S COMPLICATED IN A WAY I
THINK MAKES IT INACCESSIBLE,
PROBABLY AMPLIFIES INEQUITY AND
WE WOULD DO WELL TO CONSIDER A
BETTER WAY OF DESCRIBING WHAT
THIS IS ABOUT.
WHAT THIS REMINDED ME OF, AS I
WAS REENGAGING WITH DETAILS,
REMINDED ME OF BUILDING CODES.
HOW COMPLICATED BUILDING CODES
ON.
THE PURPOSE ARE TO ESTABLISH
SAFETY OF A BUILDING AND ITS
PERFORMANCE.
SO THERE IS SOMETHING ABOUT THAT
THAT CLICKED FOR ME, THAT MAYBE
WHAT WE'RE DOING HERE IS TRYING
TO ESTABLISH SAFETY WITH RESPECT
TO RESEARCH AND PRACTICE OF
BIOLOGY AND BIOTECHNOLOGY, ALSO
PERFORMANCE OF TEAMS, ENHANCING
ABILITY TO DO USEFUL STUFF.
A BETTER LABEL, MAYBE THE
BIOCODES OR BIOLOGY CODES,
HELPFUL TO LET MORE PEOPLE
UNDERSTAND WHAT WE'RE TALKING
ABOUT.
EVENTUALLLY EVERYONE, IS THE
JUICE WORTH THE SQUEEZE, IS THIS
WORLD IT -- WORTH IT?
IT REVEALS WHAT'S MISSING.
IF YOU'RE THINKING ABOUT
CONSTRUCTION AND THINGS INVOLVED
IN CONSTRUCTING A BUILDING OR
BRIDGE BUILDING CODES DON'T
COVER IT ALL.
HOW TO REVEAL WHAT WE'RE MISSING
WITH WHAT WE'RE DOING, RIGHT?
WE'RE FOCUSED ON PLANT HEALTH,
ANIMAL HEALTH, PUBLIC HEALTH.
ANOTHER THING IS POLITICAL
HEALTH, HOW ARE WE SECURING
POLITICAL HEALTH?
I MEAN TRUST IN SCIENCE AND
MEDICINE, TRUST AMONG NATION
STATES, SUSTAINED
DEMILITARIZATION OF BIOLOGY, AND
SO ON.
THE CURRENT SITUATION THINKING
ABOUT BIOCODES, POLITICAL HEALTH
IN PARTICULAR, A LOT OF WHAT'S
BEEN DEVELOPED IS MODE
VACCINATED TO STRENGTHEN
POLITICAL HEALTH BUT REVEALED
THROUGH THE PANDEMIC ONGOING
SOME GAPS.
WE'VE ALL ASKED OURSELVES OR
HAVE BEEN ASKED WHERE DID
SARS-COV-2 COME FROM?
A QUESTION WE COULD ASK OF THE
CURRENT DURC POLICIES AND
PANDEMIC POTENTIAL PATHOGEN
POLICIES IS DO OUR CURRENT
POLICIES MAKE IT EASIER TO
ANSWER THAT QUESTION OR MORE
DIFFICULT TO ANSWER THAT
QUESTION?
AND I WOULD ARC -- ARGUE,
WHETHER WE CAN TRUST EACH OTHER,
WHERE THINGS CAME FROM, MAKES IT
MORE DIFFICULT OR IMPOSSIBLE TO
ACHIEVE OPERATIONALLY.
ONE QUESTION WE'VE BEEN ASKED,
ARE THERE EXAMPLES OF DIFFERENT
APPROACHES?
WE HEARD ABOUT CYBER AND
FORECASTING AS ONE SUGGESTION.
I WANT TO SHARE MY EXPERIENCE
WITH W.H.O. LOOKING AT SMALLPOX
AND GOVERNANCE OF RESEARCH, A
DIFFERENT APPROACH FROM HOW WE
THINK OF PANDEMIC POTENTIAL
PATHOGENS AND DURC.
CAN I DO RESEARCH ON SMALLPOX
USING LIVE VIRUS?
THE ANSWER IS NO.
BUT WAIT, I NEED TO DO THE
EXPERIMENT.
PLEASE?
THE ANSWER IS NO BUT MAYBE.
RIGHT?
AND THE MAYBE IS SEND US YOUR
PROPOSAL, WE MIGHT SAY YES ONLY
IF THE RESEARCH IS ABSOLUTELY
NECESSARY TO ADVANCE ONE OF
THREE THINGS, DIAGNOSTIC,
TREATMENT, MEDICINE, AND YOU'VE
GOT TO USE LIFE VIRUS, OTHERWISE
NO.
THE DETERMINATION IS
MULTI-LATERAL INTERNATIONAL
REVIEW.
AND YES, IF YOU DO THE WORK IT
HAS TO BE IN A LAB SUBJECT TO
REGULAR MULTI-LATERAL
INTERNATIONAL INSPECTION,
OTHERWISE NO.
NOW IS THIS SAY APPROACH
APPROACH PERFECT?
UH-UH.
DURING THE PANDEMIC AND AFTER I
THINK THIS IS APPROACH IS MUCH
BETTER AT ESTABLISHING AND
SUSTAINING TRUST WITH RESPECT TO
POTENTIALLY CONTROVERSIAL
RESEARCH.
SO, I'D LIKE TO SUGGEST WE AT
LEAST CONSIDER ADOPTING NO-LIKE
APPROACHES FOR LIMITED NUMBER OF
PANDEMIC-CAUSING INFECTIOUS
AGENTS, AT LEAST CONSIDER IT.
I MENTION THE TRUST.
I WANT TO ELABORATE IN CLOSING.
APPROACHING HIS 100th BIRTHDAY
GEORGE SCHULTZ SHARED THOUGHTS
ON TRUST VIA A WASHINGTON
POST-OP ED.
I'M STILL LEARNING FROM THIS OP
ED.
HE WROTE TRUST IS THE COIN OF
THE REALM.
WHEN TRUST WAS IN THE ROOM, IN
HIS EXPERIENCE, WHATEVER THAT
ROOM WAS, THE FAMILY ROOM,
SCHOOL ROOM, LOCKER ROOM, OFFICE
ROOM, GOVERNMENT ROOM, MILITARY
ROOM, GOOD THINGS HAPPENED.
WHEN TRUST WAS NOT IN THE ROOM,
GOOD THINGS DID NOT HAPPEN.
EVERYTHING ELSE IS DETAILS.
DO WE HAVE TRUST IN BIOLOGY?
HOW DO WE CREATE STRENGTHENED
AND SUSTAINED TRUST IN BIOLOGY
AS AREA OF RESEARCH AND
INCREASINGLY AREA OF PRACTICE?
DO WE NEED TO DO THIS?
ABSOLUTELY!
WHENEVER SOMETHING BECOMES
IMPORTANT ENOUGH FOR HUMANITY
AND CIVILIZATION, WE HAVE TO
DEVELOP ADDITIONAL TOOLS TO
SUPPORT THE NEWLY IMPORTANT
THING.
BIOLOGY IS BECOMING INCREASINGLY
IMPORTANT.
WE'RE IN THE THIRD DECADE OF
THE, QUOTE, BIOCENTURY.
THE EASIEST WAY TO THINK ABOUT
IT IS MONEY.
MONEY WAS INVENTED IN THE
HISTORY OF HUMANITY AND BECAME
USEFUL.
ALONG THE WAY WE LEARNED THAT
MONEY IS NOT ALWAYS USED FOR
GOOD.
I.E. CAN WE TRUST PEOPLE IN
INSTITUTIONS WITH MONEY?
MOSTLY YES.
ALWAYS NO.
WE NO SOME PEOPLE WILL MISUSE
AND CAUSE HARM VIA MONEY.
WHAT DO WE DO ABOUT IT?
DEVELOP AUXILIARY TOOLS AND
MECHANISMS TO CREATE
STRENGTHENED AND SUSTAINED TRUST
IN MONEY, ARE THEY PERFECT, THEY
OFFER MANY EXAMPLES OF
OPPORTUNITIES TO CONSIDER TO
ADVANCING BIOTRUST, INCLUDING
MECHANISMS THAT CAN BE
DISTRIBUTED, BOTTOM UP, PRIVATE
SECTORIZED, INDIVIDUALIZED, SO
ON.
WHEN WE THINK ABOUT SOME OF THE
ASPECTS OF BIOSECURITY AND
BIORISK AND FAILURES OF NATION
STATE LEVEL INSPECTIONS,
BIOCAPACITIES, LEAKING INTO
INDUSTRIAL ESPIONAGE MAYBE WE
SHOULD GIVE THAT TO TRUSTED
THIRD PARTIES TO DO AUDITS UNDER
BELIEVABLE CONFIDENTIAL
AGREEMENTS YET EMIT CERTIFICATES
OF TRUST THAT CAN CREATE AND
SUSTAIN TRUST AMONG NETWORKS.
TO WRAP UP, IF YOU WERE TO LOOK
AT PERIOD OF TIME FROM 1950 TO
2050, I THINK HISTORIANS WILL
LABEL THIS CENTURY, 100- YEAR
PED AS THE BIOTIC TRANSITION.
IN 1950 WE DIDN'T HAVE THE
STRUCTURE OF DNA.
BY 2050 FRANKLY WHAT I SEE
ANYBODY ANYWHERE WILL PARTNER
WITH BIOLOGY TO GROW WHATEVER
BIOLOGY CAN BE PROGRAMMED TO
GROW.
THAT'S GOING TO BE THE END OF
THE BIOTIC TRANSITION.
WE THINK ABOUT PRACTICE OF DOING
RISKY THINGS.
CONSERVATIVE ASSUMPTION IS
THAT'S JUST GOING TO BE
POSSIBLE.
AND SO HOW DO WE GET TO THAT
FUTURE IN A WAY WHERE WE ADDRESS
THESE CONCERNS SUCH THAT WE CAN
TRUST EACH OTHER WITH BIOLOGY.
I'M GRATEFUL FOR THE LEGACY AND
HISTORY OF ONGOING DELIBERATIONS
IN THE NSABB BUT ENCOURAGE US
TO IMAGINE WHERE WE LEANING
TOWARDS AND ENDING UP AND BUILD
CAPACITIES NOT JUST AROUND DURC
AND PANDEMIC POTENTIAL AND
BIOSAFETY AND BIOSECURITY BUT
THINGS THAT ARE MORE ACCESSIBLE,
UNDERSTANDABLE, BIOCODES AND
BIOTRUST.
THANK YOU VERY MUCH.
>> THANKS.
YOU'VE GIVEN US THOUGHT
PROVOKING WAYS TO LOOK AT THE
FUTURE AND WE'LL HAVE TO SPEND
MORE TIME UNPACKING.
HOW DO WE GET TO YEAR 2050 WITH
THE FOUNDATION OF TRUST AND
RESPECT.
THANK YOU FOR YOUR COMMENTS.
NOW WE'RE GOING TO GO TO AN
OPPORTUNITY FOR QUESTIONS AND
DISCUSSION.
I DON'T SEE ALL THE PARTICIPANTS
YET.
WE HAVE AN OPPORTUNITY FOR OTHER
PANELISTS, THIS PANEL AND ANY
OTHERS IN THE SESSION 2 AND 3,
NSABB MEMBERS WHO WISH TO ASK
SESSION 1 PANELISTS A QUESTION,
NOW IS YOUR OPPORTUNITY.
I DON'T KNOW WHO HAS HANDS UP
YET.
>> I'LL HELP YOU TO CALL ON
HANDS SO YOU CAN HE CAN TO US ON
CONTENT.
>> ANY HANDS UP?
NO HANDS UP?
>> WE DO.
>> OKAY.
>> GREAT.
REALLY GREAT DISCUSSION.
REALLY GREAT FOOD FOR THOUGHT
FOR MANY DIFFERENT AREAS, EACH
OF OF YOU TOUCHED ON.
MY QUESTION IS MORE ON
INTANGIBLE TECHNOLOGIES.
I'D LOVE TO GET PERSPECTIVES,
DUAL USE LIES ON A SPECTRUM, I'D
LIKE TO GET YOUR THOUGHTS ON
RISK OF TRANSFER OF TANGIBLE
TECHNOLOGIES, DO YOU THINK MORE
SHOULD BE DONE ON THAT ASPECT?
OPEN TO ANYBODY WANTING TO
PROVIDE THEIR THOUGHTS OR
SUGGESTIONS ON THAT.
>> SOMEBODY STEP FORWARD.
>> YEAH, I THINK IT DEPENDS ON
WHAT WE'RE TRYING TO ACCOMPLISH.
IT'S A GREAT QUESTION.
AND OFTENTIMES THE QUESTION OF
KNOWLEDGE SKILLS, DATA,
CAPACITIES WHEN BROUGHT IN THE
CONTEXT OF RISK OR GEOPOLITICAL
COMPETITION TRENDS TOWARDS
KEEPING IT CLOSE OR LOCKING IT
DOWN.
I THINK A LOT ABOUT DEMOCRACY.
AND HOW BIOLOGY AND
BIOTECHNOLOGY IS RELATED TO
DEMOCRACY.
ONE OF THE THINGS THAT TURNS
INTO A QUESTION FOR ME AT LEAST
IS WHEN I THINK ABOUT OUR
BIOLOGICAL FUTURE, AM I A
CITIZEN OF THAT FUTURE OR A
CONSUMER OF THAT FUTURE OR
SUBJECT OR OBJECT IN THAT
FUTURE?
AND I'M BIASED.
LIKE I WOULD PREFER TO BE A
CITIZEN.
I WOULD PREFER TO HAVE AN
AMERICAN BIOECONOMY THAT
ADVANCES NOT ONLY LIFE WITH
MEDICINE, FOOD, FUEL, SHELTER,
ALSO LIBERTY AND PURSUIT OF
HAPPINESS.
WHAT DOES THAT MEAN IN PRACTICE?
AND UNDERNEATH IT ALL IT MEANS
THAT PEOPLE SHOULD HAVE THE
OPTION OF ACCESSING ESSENTIAL
CAPACITIES, WHETHER PUBLIC
HEALTH OR ABILITY TO EARN A
LIVELIHOOD OR EDUCATION OR SO
ON.
AND SO THAT I THINK IS WHAT
UNDERLIES AND PUT IN MOTION MANY
OF THE ACTIVITIES I'M PART OF
THAT RESULT IN PRACTICALLY
PROMULGATION OF KNOWLEDGE AND
DATA AND AWARENESS AND
CAPACITIES, BECAUSE WE'RE GOING
FOR CITIZENSHIP.
A FUTURE COMPRISED OF
BIOCITIZENS.
HOW TO STEWARD THAT, RIGHT, IN
WAYS THAT ARE RESPONSIBLE I
THINK MARIA GIVES GREAT
EXAMPLES, BUT I WOULDN'T
REPRESENT THOSE AS BEING
COLLECTIVELY SUFFICIENT.
AND THEN WHAT DO WE DO ABOUT IT?
FOR ME AT LEAST WHAT IT LEADS TO
IS I'D LIKE TO HAVE A DISCUSSION
ABOUT CONSERVATIVE STARTING
ASSUMPTIONS RELATED TO
BIOSECURITY VICTORY.
WHAT ARE OUR VICTORY CONDITIONS
FOR FUTURE WHERE WE'RE NOT AS
CONCERNED ABOUT - -- - MAYBE WE
MAKE INFECTIOUS DISEASE
OBSOLETE, PLEASE, AND WHAT DO WE
NEED TO DO TO GET TO THAT
POSITIVE OUTCOME FROM A VICTORY
CONDITION PERSPECTIVE AND COUPLE
THAT TO PROMULGATION OF
KNOWLEDGE SKILLS AND
CITIZENSHIP?
I DON'T THINK YOU CAN ADVANCE
ONE WITHOUT THE OTHER, IT HAS TO
GO HAND IN HAND.
OTHERWISE YOU WANT TO SHUT
EVERYTHING DOWN WHICH DOESN'T
GET US TO ANYPLACE GOOD EITHER.
>> A QUICK QUESTION, I WOULD
LIKE TO POSE THE QUESTION TO YOU
SINCE YOU'RE A FORMER NSABB
MEMBER, OFFERED A GOOD ANALOGY
WITH SMALLPOX INTERNATIONAL
SCIENTIFIC REVIEW COMMITTEE.
ON A STEP GETTING TO A BIOCODE,
I LIKE THAT ANALOGY TOO, BUT
WHAT ARE THE OPPORTUNITIES FOR
INTEGRATING THE VARIOUS PATCH
WORK OF OVERSIGHT POLICIES THAT
WE HAVE TODAY, DURC, P3CO,
SELECT AGENTS, DO YOU HAVE
THOUGHTS OF CONSOLIDATING,
INTEGRATING ON A WAY TO A
BIOCODE?
>> IT'S A GREAT QUESTION.
I'M THINKING.
YEAH, WHAT I WOULD SAY IS, IN MY
EXPERIENCE, THIS IS A VERY
BIOFOCUSED CONVERSATION, BUT IN
MY BROADER EXPERIENCE MOST OF
OUR LEADERSHIP IN INSTITUTIONS
AND ORGANIZATIONS IS ABIOTIC,
LIVING CREATURES, PEOPLE,
OFTENTIMES DO NOT HAVE WORKING
KNOWLEDGE OF BIOLOGY.
THEY MIGHT BE AN EXPERT IN, SAY,
NUCLEAR SECURITY OR SOVIET UNION
HISTORY OR WHAT HAVE YOU, STILL
TO THIS DAY MOST OF OUR LEADERS
ACROSS CORPORATIONS,
INSTITUTIONS, GOVERNMENT, I
WOULD CALL ABIOTIC.
MANY OF US IN BIOLOGY, ALTHOUGH
WE WRESTLE WITH STRATEGIC
TOPICS, ARE NOT ALWAYS WELL
FAMILIAR WITH STRATEGY AND GEO
POLITICS AND SO ON AND SO FORTH.
IT'S NOT THAT ANYBODY'S AT FAULT
OR BAD, BUT THEY ARE MERGING
QUICKLY ENOUGH, QUICKER THAN
PEOPLE ARE LEARNING FROM EACH
OTHER SO MY HIGH LEVEL COMMENT
IN RESPONSE, WE HAVE TO WEAVE
TOGETHER, USG HAS A CRITICAL
ROLE, URGENCY, AWARENESS OF
BIOLOGY AS STRATEGIC DOMAIN TO
E. THAT CAN LEAD TO CIVIL
DECISION SCALE FLOURISHING THAT
DEMOCRATIZES BUT COMES WITH RISK
AS WE'RE FOCUSING ON HERE.
GETTING AWARENESS AND
CONVERSATION SUSTAINED AS
ALL-HANDS APPROACH ACROSS
GOVERNMENT IS STILL I WOULD SAY
A WORK IN PROGRESS AND COULD BE
STRENGTHENED AND AM LOUSE IF
WE -- ALLOWS IF WE DO IT RIGHT
HOW DO WE SUSTAIN METAGENOMIC
EXPERIENCE IN PERPETUITY.
WRAPPING UP POLICIES IN THE
CONTEXT WHERE WE HAVE BIOTIC
LEADERSHIP, COLLECTIVELY, FEELS
LIKE THE NEXT MOVE.
>> YEAH, THANK YOU.
>> WE HAVE PANELISTS WITH A HAND
UP.
>> THAT WAS FANTASTIC.
THIS MIGHT BE FOR MARIA BUT A
GENERAL QUESTION AS YOU WERE ALL
TALKING, THINKING ABOUT TRUST IN
THE COMMUNITY REMINDED ME ABOUT
THE POTENTIAL ROLES OF COMMUNITY
BIOSAFETY BOARDS WHICH NOBODY
HAS REALLY MENTIONED, AND THAT
SEEMS LIKE A POTENTIAL CONDUIT
FOR A LOT OF THE THINGS THAT YOU
ALL ARE TALKING ABOUT AND WANTED
TO GET YOUR THOUGHTS ON THAT.
>> NO, THAT'S SOMETHING MY
COMMUNITY, THE GLOBAL COMMUNITY,
HAS BEEN DISCUSSING AS SOMETHING
THAT THEY WANT TO BUILD OUT AND
LOOK TOWARDS IS, AGAIN, LOOKING
AT TOP LEVEL QUESTIONS DREW
ASKED, THE PURPOSE OF IRB.
WE HAVE A SUBGROUP MEETING FOR
TWO YEARS, NOT OFTEN ENOUGH,
THAT WANTS TO TRY TO CREATE AN
IRB STRUCTURE FOR COMMUNITY LABS
AT LEAST IN THE U.S. BUT WE'RE
ASKING BIGGER QUESTIONS LIKE
WHAT IS IT IRBs DO AND LOOK AT
IT AND HOW CAN WE MAKE THEM MORE
EFFICIENT AT GETTING AWAY FROM
BUREAUCRACY, GUIDING PEOPLE WHO
WANT TO DO EXPERIMENTS SAFELY
BECAUSE I THINK THAT WE NEED TO,
AGAIN, I LEAN STRONGLY TO WHAT
DREW SAID, BUILD COMMUNITIES OF
TRUST, BUILD BOTTOM-UP TRUST NOT
JUST WITH RESEARCHERS BUT
GENERAL PUBLIC BECAUSE I DO FEEL
LIKE THE FAULTS IN THE SYSTEM
THIS PANDEMIC HAS SHOWN US WHERE
WE DON'T HAVE TRUST IN SCIENCE,
IN POLICIES, IN TECHNOLOGY, AND
WE NEED TO REBUILD THOSE ROADS
AND SO FIGURING OUT, YOU KNOW,
HOW CAN WE GET A COMMUNITY
REVIEW BOARD, HOW CAN WE
IDENTIFY AND CREATE BOTH WITH
THE COMMUNITY, WHICH MEANS THE
RESEARCHERS WHO WANT TO DO
COMMUNITY RESEARCH, WITH THE
COMMUNITIES THEMSELVES, AS WELL
AS POTENTIALLY FEDERAL AGENCIES
THAT WANT TO SUPPORT US IS
IMPORTANT CONVERSATIONS AND
SUBGROUP WORKING ON THAT IRB HAS
MULTIPLE FOLKS WHO RUN THEIR
UNIVERSITY'S IRB GROUPS.
SO WE'RE LOOKING AGAIN AT
RETHINKING WHY ARE WE DOING THIS
AND HOW CAN WE DO IT BETTER.
AND A LITTLE BIT MORE FLEXIBLE
EXAMPLE OF HOW TO DO THAT.
>> THANK YOU.
LYRIC, ARE YOU SEEING ANY OTHER
HANDS UP?
>> I WOULD LOVE TO ASK A
QUESTION, IF POSSIBLE.
I HEARD SOME THEMES FROM THE
FIRST PANEL ON THE SCOPE AND
DEFINITION FOR THIS SECTION.
I'D LIKE TO THINK ABOUT SOME
CONCRETE STEPS MOVING FORWARD,
THEME OF BOUGHT-UP, RISK BASED
APPROACH IS NOT NECESSARILY
WITHIN THE SCOPE OF 7, 15, OR
LISTED CATEGORIZATIONS.
ON THE SAME VEIN, MAKING
CONVERSATION ACCESSIBLE AND
BUILDING TRUST, WHAT YOU THINK
THE FUTURE LOOKS LIKE, HOW ARE
YOU CONCRETE IN MAKING THINGS
ACCESSIBLE AND DEFINING WHAT WE
MEAN HERE BUT ALSO HAVING THE
FLEXIBILITY AND FLUIDITY AROUND
CULTURE, RISK ASSESSMENT, WHAT
ARE YOUR THOUGHTS ABOUT THE NEXT
STEPS FOR THE POLICY?
>> I'LL JUMP IN BECAUSE YOU SAID
KEY WORDS I LOVE, CULTURE AROUND
COMMUNITY.
I THINK THAT ONE OF THE THINGS I
TEND TO SEE BEING OUTSIDE OF
U.S. GOVERNMENT BUT WORKING VERY
DILIGENTLY FOR TEN YEARS NOW
BUILDING A GLOBAL COMMUNITY AND
STARTING TO STEWARD THAT IS THAT
ONE OF THE THINGS I'D LOVE TO
SEE IS MORE COMMUNICATION
AMONGST FEDERAL AGENCIES.
I THINK RIGHT NOW THE
DISTRIBUTED NATURE OF THESE
POLICIES AND AGENCIES THAT ARE
IMPLEMENTING THEM IS ONE OF THE
WEAKNESSES, IS GETTING SOME MORE
UNIFIED APPROACHES TO THEM, MORE
DISCIPLINARY APPROACH BUT IN
GENERAL IF YOU WANT TO BUILD
COMMUNITY YOU START WITH THE
COMMUNITY YOU HAVE AND YOU HAVE
THIS COMMUNITY ALREADY IN THE
U.S. GOVERNMENT.
SO START WITH BUILDING COMMUNITY
THERE AS WELL AS REACHING OUT TO
STAKEHOLDERS IN THE OTHER
IDENTIFIED GROUPS YOU WANT TO
TALK WITH, AND INVITING THEM
INTO THE CONVERSATION.
I THINK THAT'S STEP ONE.
>> JIM, I'D LIKE TO HEAR YOUR
THOUGHTS ON THAT.
MY THOUGHTS WERE SIMILAR TO
LYRIC'S.
YOU ALMOST LAID OUT A LOT OF
THINGS THAT COULD BE TURNED INTO
A ROADMAP OF ACTION ITEMS.
AND MAYBE ONE SPECIFIC ACTION
ITEM IS HOW DO WE ELEVATE THE
IBC TO THE EQUIVALENT OF IACUC
AND REVIEW BOARDS?
THAT'S AN ACTIONABLE ITEM.
>> RIGHT.
YOU KNOW, THAT'S A GOOD
QUESTION.
I THINK THE REAL CHALLENGE IS
NOT IN ACADEMIA AND RESEARCH
ORGANIZATIONS.
I THINK IT'S IN THIS MUCH
BROADER COMMUNITY THAT WE'VE
ALREADY BEEN TALKING ABOUT AND
HOW DO WE ENGAGE THEM?
IT REALLY GOES BEYOND THE
INDIVIDUAL RESEARCHERS.
THERE'S AN ENORMOUS AMOUNT OF
ENGAGEMENT IN THE COMMERCIAL
SECTOR THAT REALLY IS
INDEPENDENTLY FUNDED, DOES THEIR
OWN THING, AND HOW DO WE ENGAGE
THEM?
FOR EXAMPLE, WE'VE ALL SEEN ADS
FOR BOTOX.
SO, HOW DO WE MAKE BOTOX?
WHAT'S THAT ENTIRE PROCESS?
ARE THERE RISKS ASSOCIATED WITH
THAT?
I MEAN, I DON'T KNOW.
I'M SURE SOMEBODY KNOWS ALL OF
THAT.
BUT THERE'S JUST A MUCH BROADER
COMMUNITY THAT WE NEED TO FIGURE
OUT WAYS TO ENGAGE IN.
AND I THINK WE DO HAVE A GOOD
STRUCTURE IN PLACE.
AND I LOVE THE EMPHASIS ON
CULTURE OF RESPONSIBILITY.
I ABSOLUTELY THANK DREW FOR
RECALLING THE GEORGE SCHULTZ
EDITORIAL.
I MEAN, THAT WAS SUCH A
BEAUTIFUL PIECE.
SO I THINK THE FOUNDATION IS
THERE.
HOW DO WE OPEN THE GATES SO
WE'RE MORE INCLUSIVE?
NOT ONLY WITHIN THE GOVERNMENT
BUT MUCH MORE BROADER.
LET ME STOP.
THANK YOU.
>> OTHERS?
WE'VE BEEN TALKING ABOUT A
CULTURE OF RESPONSIBILITY FOR
QUITE SOME TIME.
WE REALLY HAVE TO PROPAGATE IT
OUT IN OUR OTHER THAN COUNTRY
AND ACROSS THE WORLD.
WE'VE GOT TO FIGURE OUT THE WAY
TO TAKE ACTION ON THAT.
>> I SEE TWO HANDS AND WE'LL
HAVE TO GO TO A BREAK.
FIRST KENNETH BERNARD AND
CARMELA HAINES.
>> CAN YOU HEAR ME OKAY?
>> YEAH.
>> I'M ON A PLANE.
I WANT TO EMPHASIZE WHAT BOTH
DREW AND JIM JUST SAID.
WE'VE GOT TO EXPAND THE
OVERSIGHT IF WE WANT TO BE TAKEN
SERIOUSLY IN THE NATIONAL
SECURITY STRATEGIC POLICIES
ARENA WE'VE GOT TO GET OUT OF
OUR BIOWORLD WHERE WE ALL KNOW
EACH OTHER.
THERE SHOULD BE A BUNCH OF
PEOPLE ON THESE COMMITTEES THAT
COME FROM DIFFERENT SECTORS,
PRIVATE AND PUBLIC, INCLUDING
DEFENSE SECTORS AND OTHERS.
I THINK A RECENT INFORMATION WE
JUST GOT A P3CO REALLY IT'S ONLY
HHS WHO IS CONCERNED ABOUT IT.
IT'S SHOULD BE A CONCERN ACROSS
THE U.S. GOVERNMENT AND
INTERNATIONALLY.
DREW NAILED THIS.
WE HAVE TO STOP LOOKING FROM A
BIOSPECIFIC PERSPECTIVE AND LOOK
AT A STRATEGIC ISSUE, LOOK AT
IMPACT OF COVID OR DISCUSSION ON
SMALL POSITION TO REALIZE WHY
THAT'S THE CASE.
THANK YOU.
>> IT'S A CONVERSATION WE'VE
BEEN TRYING TO HAVE FOR SOME
TIME BUT NOW IS THE TIME.
>> I SEE CARMELA.
>> HELLO, EVERYBODY, FROM EMORY
UNIVERSITY, MEMBERS OF NSABB.
GOOD TO SEE EVERYONE.
I WANTED TO FOLLOW UP AND AND
DREW'S POINT, ABOUT POLITICAL
HEALTH, RIGHT?
THAT'S HUGE, RIGHT?
SCIENTISTS ARE GOOD AT
ENGINEERING SOLUTIONS, TECHNICAL
SOLUTIONS FOR PROBLEMS BUT USING
COVID AS AN EXAMPLE WE'VE HAD
THIS BEAUTIFUL SORT OF SPED-UP
DEVELOPMENT OF A VACCINE THAT IS
SAFE AND THEN WE SEE YOU CAN
DEVELOP THIS BEAUTIFUL THING,
AND THEN IT'S UP TO A PERSON TO
ACTUALLY TAKE THE VACCINE SO
THERE'S ALWAYS THAT PART.
I WANTED TO SECOND HIS POINT.
IT'S ABSOLUTELY IMPORTANT AND
SORT OF DEALING WITH THE ASPECT
OF THINGS, FOLKS SHY AWAY, IT'S
HARD.
IT'S NOT EASY.
THIS IS NOT NECESSARILY A
CRITICISM, IT'S HARD TO DO BUT
THAT DOESN'T MEAN WE SHOULD NOT.
I JUST WANTED TO ALSO ADD WHAT
I'VE WITNESSED ON THE GROUND,
SOME THINGS I'VE OBSERVED, THE
PUSHBACK AND REJECTION AND
MISTRUST, KEY FACTOR IN THAT IS
THAT WHEN THERE IS SORT OF LIKE
A HOLE OR GAP THAT SORT OF
DIVIDES, YOU KNOW, PRACTICING
SCIENTISTS FROM PEOPLE WHO DON'T
HAPPEN TO BE PRACTICING
SCIENTISTS, THERE'S THIS HOLE
THAT'S GETTING FILLED IN BY
PEOPLE WHO HAVE ALL THE
CONFIDENCE AND NO COMPETENCE,
WHO PROCLAIM THEY KNOW THINGS,
THAT THEY DON'T.
LITERALLY TO AVOID USING THE
BUZZWORD, MISINFORMATION, THAT
PLAYED A HUGE ROLE IN KEEPING
THAT DIVIDE THERE, EVEN WIDENING
IT.
I WOULD LIKE TO HE SEE US GET
COMFORTABLE.
ANTICIPATE AND ENGAGE.
WE SEPARATE OURSELVES FROM
PEOPLE RUNNING AROUND SPREADING
MISINFORMATION, WHO EVEN MAKE A
SHOW OUT OF CONFRONTING
SCIENTISTS AND ALL THIS, WE
SHOULDN'T GIVE UP IN THAT ARENA
BECAUSE YOU DEFINITELY LOSE WHEN
YOU COMPLETELY DISENGAGE.
WHAT'S GIVEN ME HOPE, I PRAISE
PEOPLE WITH ENOUGH PATIENCE TO
GET INTO THAT ARENA AND ENGAGE
BUT HAVING US CONSTANTLY SORT OF
BEING THERE AND BEING PRESENT
AND ALSO INVITING PEOPLE INTO
CONVERSATIONS IS CRITICAL.
I'VE SEEN SOME AMAZING PUBLIC
SCIENCE AND PUBLIC EDUCATION
PEOPLE JUMP INTO THE RING AND
PUSH BACK AGAINST A LOT OF
INFORMATION AND I'VE WITNESSED
AT A MICROSCALE THAT ENGAGEMENT
ACTUALLY HAVING A GOOD SORT OF
OPPOSITE AND POSITIVE EFFECT TO
HELP HEAL THE MISTRUST AND THE
SEPARATION.
>> THANK YOU FOR THOSE COMMENTS.
WE HAVE TO STAY ENGAGED IN
MULTIPLE ARENAS, INCLUDING
POLITICAL ARENA AND NATIONAL
SECURITY ARENA.
WE'VE COME TO THE END TIME OF
THIS SESSION.
I THANK OUR PANELISTS.
IF WE WERE IN PERSON I WOULD ASK
FOR A ROUND OF APPLAUSE FOR YOUR
THOUGHTFUL COMMENTS AND
PREPARATION FOR THIS SESSION AND
I THANK THE PANELISTS AND
MEMBERS FOR ASKING THOUGHTFUL
QUESTIONS, ENGAGING IN
DISCUSSION.
LYRIC, BACK OVER TO YOU FOR
DIRECTIONS ON THE BREAK AND
RECONVENING.
THANK YOU.
>> I SECOND YOUR THANKS TO THE
PANELISTS AND THOSE WHO
PARTICIPATED.
WE ARE TO GIVE EVERYONE A FULL
TEN MINUTES, LET'S RECONVENE AT
1:35 FOR SESSION 2, TURN YOUR
CAMERAS OFF AND WE'LL REJOIN AT
1:35 PROMPTLY.
I'M EXCITED TO INTRODUCE YOU ALL
TO MS. RACHEL LEVINSON, NATIONAL
RESEARCH INITIATIVES KNOWLEDGE
ENTERPRISE, ARIZONA STATE
UNIVERSITY, AS MODERATOR FOR
SESSION 2, FOCUSED AROUND DURC
POLICY IMPLEMENTATION, IN
RELATION TO OTHER OVERSIGHT
APPROACHES TO ASSESSING AND
EDUCATING STAFF ABOUT RISK AND
THOUGHTS REGARDING BENEFITS AND
CHALLENGES TO RESEARCHERS,
PROJECTS CONSIDERING POLICY
SCOPE AND POTENTIAL FUTURE
CHANGES.
I RECOGNIZE THESE WERE TOGETHER
AND THAT'S OKAY, WE'LL CAPTURE
THE KEY POINTS MOVING FORWARD.
RACHEL, I HAND IT OVER TO YOU.
>> THANK YOU AND THANKS TO THE
STAFF OF THE OFFICE OF SCIENCE
POLICY BECAUSE PUTTING THIS
TOGETHER IS TIMELY AND
NECESSARY.
I THINK THE SPEAKERS ON THE
PREVIOUS PANEL IDENTIFIED A
NUMBER OF AREAS WHERE THAT
BECOMES PARENT.
GETTING YOUR BACKGROUND ON THE
ATMOSPHERE AND ATTITUDE TOWARD
DURC RESEARCH BACK IN THE DAYS
WHEN THIS POLICY OR SET OF
POLICIES WAS BEING DEVELOPED WAS
HELPFUL ESPECIALLY NOW AS WE
LOOK AT IT THROUGH THE LENS OF
THE CURRENT PANDEMIC AND SOME
CHANGES THAT HAVE TAKEN PLACE IN
THE LABORATORY PRACTICES AND
CAPABILITIES THAT WE WITNESSED,
I THINK SIGNIFICANT CHANGES, THE
PRACTICE OF PUBLISHING
PRE-PRINTS WHICH LEADS US TO
SOME THOUGHTS ABOUT
COMMUNICATION AND CYBERSECURITY
AS WELL AND SOME ISSUES
IDENTIFIED BY PREVIOUS SPEAKERS,
THEY ARE OF I HOPE THEY FOLLOW
ALONG AND ARE INVITED TO THE
DISCUSSION PORTION TO
PARTICIPATE IN THAT AS WELL
BECAUSE THEY ENUNCIATED CONCERNS
AND WE WANT TO SEE WHAT THE
IMPACT THIS PARTICULAR SET OF
PANELISTS COULD HAVE IF THAT
WERE TO CHANGE.
WE'RE GOING TO LOOK AT POLICIES
AND IMPLEMENTATION, HOW THEY
IMPACTED RESEARCH INSTITUTIONS,
RESEARCHERS, AND BROADER
RESEARCH COMMUNITY AND WHAT
WORKS WELL AND COULD BE
IMPROVED.
OUR PANEL OF THREE PEEKERS HAVE
GREAT EXPERTISE AND WILL BE
REPRESENTING THE VIEWS OF
INSTITUTIONS, THOSE WITH WHICH
THEY MAY BE FAMILIAR AS WELL
THAT WILL BE BRING A LOT TO THIS
DISCUSSION.
WE ALSO WANT TO HEAR AS TO
WHETHER OR NOT THERE ARE
DIFFERENT MODELS OF
IMPLEMENTATION THAT HAVE BEEN
USEFUL IN THEIR INSTITUTIONS BUT
COULD HELP IN ACHIEVING GOALS OF
THE POLICIES, WHEN THE GOALS
HAVE NOT CHANGED.
HOW DO INSTITUTIONS GO BEYOND
CURRENT DURC POLICY REQUIREMENT
TO ADDRESS OTHER RISKS, ONE AREA
THERE MIGHT BE TO LOOK AT
TRAINING THAT THEY USE,
TRAININGS AND MATERIALS AND
OTHER RESOURCES PROVIDED BY THE
FEDERAL GOVERNMENT AND PERHAPS
IDENTIFY ONES WHERE THEY FEEL
MORE COULD BE DONE.
WE WOULD LIKE THE PANELISTS TO
LOOK AT WHAT IMPACT THE POLICIES
HAVE HAD ON PUBLICATION AND
DISSEMINATION, TAKING ON NEW
MEANING WHERE THERE'S
DISCUSSION.
WE KNOW THERE'S GOING TO BE
DISCUSSION BEFORE PUBLICATION
BUT PRE-PRINTS, PRE-PUBLICATION
DISCUSSION THAT DON'T HAVE
ADVANTAGE OF PEER REVIEW RAISE
NEW QUESTIONS THAT I THINK ARE
WORTH LOOKING AT.
I'D LIKE TO INTRODUCE THE THREE
SPEAKERS AND GO FOR TEN MINUTES
EACH AND IF I CAN ASK YOU TO
KEEP YOUR CAMERAS ON FOR THE
ENTIRE SESSION THAT WOULD BE
HELPFUL FOR DISCUSSION.
KALPANA WORKS AT EMORY
UNIVERSITY IN ATLANTA, DIRECTOR
OF RESEARCH SAFETY FOR
ENVIRONMENTAL HEALTH AND SAFETY
OFFICE, AND INSTITUTIONAL
BIOSAFETY OFFICER.
SHE'S RESPONSIBLE FOR
DEVELOPING, IMPLEMENTING
MAINTAINING LABORATORY SAFETY
PROGRAMS, TO CONTROL
OCCUPATIONAL EXPOSURES AND
OVERSEE IMPLEMENTATION AND
COMPLIANCE WITH FEDERAL AND
STATE LAWS, AND PROVIDES
BIOSAFETY SUPPORT FOR THE
COMMUNICABLE DISEASE UNIT AT
EMORY AND PRIOR TO EMORY WAS
RESEARCH ASSOCIATE AT THE
VACCINE CENTER AND VISITING
ASSOCIATE AT THE NATIONAL EYE
INSTITUTE AT NIH.
SHE HOLDS A Ph.D. IN
IMMUNOLOGY AND RECEIVED MASTER
OF PUBLIC HEALTH FROM EMORY,
SERVES ON COMMITTEES FOR ABSENT
INTERNATIONAL, HELPFUL AS A
PERSPECTIVE TO BRING TO THIS
DISCUSSION, AND IS A TECHNICAL
WRITER.
JOE KANABROCKI IS PROFESSOR OF
MICROBIOLOGY, UNIVERSITY OF
CHICAGO, A VOTING MEMBER OF THE
INSTITUTIONAL BIOSAFETY
COMMITTEE, VICE CARE OF SELECT
AGENT INSTITUTIONAL BIOSAFETY
COMMITTEE, RESPONSIBLE OFFICIAL
FOR U.C. SELECT AGENT PROGRAM,
FORMER VOTING MEMBER OF THE NIH
RECOMBINANT DNA ADVISORY
COMMITTEE AND NSABB WHERE HE
SERVED ON THE DURC WORKING GROUP
AND CO-CHAIR OF NSABB GAIN OF
FUNCTION WORKING GROUP.
HE'S A FORMER CO-CHAIR OF THE
EXTERNAL LABORATORY SAFETY
WORKING GROUP OF THE ADVISORY
COMMITTEE TO THE DIRECTOR OF THE
CDC.
CURRENT VOTING MEMBER OF THE
WORKING GROUP.
DR. SIMON ANTHONY, UNIVERSITY OF
CALIFORNIA DAVIS, DEPARTMENT OF
PATHOLOGY, MICROBIOLOGY AND
IMMUNOLOGY, RESEARCH ON ZOONOTIC
VIRUSES IN WILDLIFE, PRIMARILY
BATS.
THIS INCLUDES VIRAL DISCOVERY TO
BETTER UNDERSTAND MECHANISMS BY
WHICH VIRUSES ACQUIRE OR LOSE
ABILITY TO INFECT HUMAN CELLS.
THE MISSION OF HIS WORK IS TO
IMPROVE OUR UNDERSTANDING OF THE
GENETIC AND ECOLOGICAL
DETERMINANTS, SPILLOVER AND
DISEASE EMERGENCE, LONG-TERM
GOAL IS TO BUILD BETTER
INTELLIGENCE TO BE USED FOR
PANDEMIC PREVENTION.
DR. ANTHONY DID HIS DOCTORATES
AT OXFORD, FOLLOWED BY POSTDOC
POSITIONS AT SAN DIEGO ZOO AND
COLUMBIA IN NEW YORK.
I THANK YOU ALL FOR AGREEING TO
SHARE PERSPECTIVES AND
EXPERIENCE IN INSTITUTIONS YOU
REPRESENT, AND I LOOK FORWARD TO
YOUR COMMENTS.
THANK YOU.
WOULD YOU PLEASE GO AHEAD,
KALPANA?
PLEASE LEAVE YOUR CAMERAS ON.
>> CAN YOU HEAR ME?
THANK YOU, RACHEL, FOR THE
INTRODUCTION AND THANK YOU TO
THE ORGANIZERS FOR GIVING ME AN
OPPORTUNITY TO SHARE OUR
EXPERIENCE AT EMORY UNIVERSITY.
SO, BEFORE I EVEN START I WOULD
LIKE THE AUDIENCE TO KNOW EMORY
UNIVERSITY DOES NOT WORK WITH
SELECT AGENTS HERE, NOT THE
SELECT AGENT SITE.
HOW DID WE GET INTO THIS WHOLE
THING WHEN WE DON'T HAVE THOSE
AGENTS, THE 15 AGENTS LISTED
THERE OR ANY OF THE SEVEN
EXPERIMENTS?
WE AT EMORY UNIVERSITY GOT AN
NIH CONTRACT, SEVEN-YEAR
CONTRACT, INVOLVES WORK
BASICALLY THE LOW PATHOGENIC
AVIAN INFLUENCE OF WHAT WE'LL BE
USING.
IN THE CONTRACT, WE WERE TOLD A
FEW MONTHS AGO THAT WE HAVE TO
CONSIDER SARS-COV-2, AND THE
HUMAN TRANSMISSIBLE LOW
PATHOGENIC INFLUENCE OF TLBAI,
DUAL USE RESEARCH OF CONCERN
AGENTS.
TYPICALLY WHAT THEY ARE USING
FOR RESEARCH IS NOT UNDER ANY OF
THOSE 15 LISTED AGENTS BUT ASKED
TO CONSIDER SARS-COV-2 WHICH
WE'RE USING IN SOME OF THESE
EXPERIMENTS AS IF IT WAS DURC
AGENT.
AND THEREFORE WE ARE OBLIGATED
TO COMPLY WITH ALL ASPECT OF
POLICY FOR THESE PATHOGENS.
SO, THE RESEARCH THAT IS GOING
ON CAMPUS, PARTICULARLY WITH
REFERENCE IN THIS PARTICULAR
GRANT WHERE WE'RE WORKING WITH
THE CONSORTIUM THERE'S NO WORK
CAN SARS-COV-2 BUT YES WE DO
WORK WITH INFLUENZA VIRUS, AND
THEN THE INVESTIGATOR IS TRYING
TO WORK WITH ONE OF THE LOW
PATHOGENIC AVIAN VIRUS, WITH
CO-INFECTION WITH ANOTHER H1N1
VIRUS.
SO THEREFORE THERE IS POTENTIAL
RISK OF INFECTION FOR LABORATORY
PERSONNEL AND OTHER INDIVIDUALS
FOR ONWARD TRANSMISSION OF
LABORATORY-ACQUIRED INFECTION IN
THE COMMUNITY.
HERE WHAT WE DO IS CO-INFECTION
OF A LOW PATHOGENIC AVIAN
INFLUENZA VIRUS WITH HUMAN
VIRUS, THIS IS THE POTENTIAL
RISK CO-INFECTION EXPERIMENTS
BEING DONE.
THERE ARE WE HAVE TO DEVELOP,
THE REQUEST WAS TO REQUEST DURC
AGENT, WE HAD TO GO THROUGH ALL
THE EVALUATIONS, MADE THE
INVESTIGATOR COME AND PRESENT
THE WORK AT OUR INSTITUTION
BIOSAFETY COMMITTEE, THE
COMMITTEE WAS ESTABLISHED, WE
HAD TO DO A TREMENDOUS AMOUNT OF
RISK MITIGATION STRATEGY,
EVALUATION, ET CETERA.
THE QUESTION BASED ON WHAT WE'RE
TALKING HERE IS HOW HAS THAT
IMPACTED THE BROADER RESEARCH
COMMUNITY?
WE FEEL THE DURC POLICIES GIVE
A USEFUL FRAME WORE FOR RESEARCH
INSTITUTIONS AND RESEARCHERS TO
WORK.
THE INSTRUCTIONS ARE VERY CLEAR,
THERE'S NO AMBIGUITY, AND
THEREFORE THAT IS ONE OF THE
BIGGEST TRENDS OF THE DURC
INSTRUCTION AND GUIDANCE FROM
NIH ON HOW INSTITUTIONS SHOULD
WORK WITH RESEARCHERS TO
UNDERTAKE RISK ASSESSMENT IS
EXTREMELY HELPFUL.
GUIDANCE DOCUMENT IS VERY
HELPFUL.
APART FROM GUIDANCE ON DURC, AS
WELL AS NIH GUIDANCE,
RESEARCHERS HAVE BEEN CLEARLY
TOLD US INVOLVEMENT OF LOCAL
INSTITUTIONAL BIOSAFETY
COMMITTEE IS A BIG STRENGTH FOR
THEM TO MAKE SURE THEY ARE DOING
THE RIGHT THING.
WHAT COULD BE A BETTER SCOPE IS
COMMUNICATION ABOUT THE TYPE OF
RESEARCH THAT GOES ON,
COMMUNICATION THAT HAS TO GO TO
THE PUBLIC.
PREVIOUS PANELISTS ALLUDED TO
PERCEPTION, PARTICULARLY IN THE
LAST FEW WEEKS WITH OUTBREAK OF
SARS-COV-2, A LOT OF THINGS
KNOWN, A LOT OF PERCEPTION AND A
LOT OF FEAR.
IN OUR EXPERIENCE, PARTICULARLY
WORKING WITH THE INFLUENZA
VIRUSES, IN THE LAST 12 YEARS
THERE HAVE BEEN SEVERAL AD HOC
RESTRICTIONS PLACED ON THE
INFLUENZA RESEARCH, BASICALLY
TWO MORATORIA, AND OUR THOUGHT
PROCESS WAS INSTEAD OF PLACING
RESTRICTION AND MORATORIUM TO
STOP WORK IT COULD HAVE BEEN
BETTER HANDLED WITHIN THE
WELL-ESTABLISHED DURC FRAMEWORK
WE HAVE NOW.
YOU HAVE TO CONSIDER THIS AS
DUAL USE RESEARCH BUT IN THE
PAST YEARS, ALL THE THINGS GOING
ON.
SUCH AN APPROACH WOULD
APPROPRIATE RESPONSE TO PUBLIC
CONCERNS, MAINLY BECAUSE THE
PUBLIC NEEDS TO UNDERSTAND THE
DIFFERENCE BETWEEN HIGHLY
PATHOGENIC INFLUENZA VIRUSES AND
NOT -- TALKING ABOUT, YOU KNOW,
NOT THE BENIGN BUT NOT HIGHLY
PATHOGENIC INFLUENZA VIRUSES,
AND THEREFORE HOW THE RESEARCH
ACTIVITIES ARE BEING HANDLED
THAT IT COULD NOT BE A PUBLIC
THREAT TO THEM.
WE NEED TO COMMUNICATE TO THE
PUBLIC IN A BETTER WAY RIGHT
THERE.
ALSO, THERE SEEMS TO BE A VIEW
AMONG THE PUBLIC AS WELL AS
POLITICIANS THAT RESEARCHERS DO
EXPERIMENTS IN SECRET.
EVERYBODY ON THIS PANEL AND
EVERY ATTENDEE HERE WILL
DEFINITELY CONCUR WITH MY
THOUGHT, THERE'S MORE PERCEPTION
OF GAIN, THINKING MORE RESEARCH
THAT'S VERY DANGEROUS AND IT'S
BEING DONE IN SECRET, THAT'S
WHAT THE PERCEPTION IS.
IN FACT OFFER TRANSPARENT AND
WELL THOUGHT OF FRAMEWORK FOR
REGULATING THAT TYPE OF RESEARCH
ON PATHOGENS THAT WE USE RIGHT
HERE.
THE OTHER THING, THE QUESTION
WAS WHAT IMPACTS POLICIES HAD ON
PUBLICATION, PUBLIC
COMMUNICATION, ET CETERA.
AGAIN, DURC USUALLY SHAPES
RESEARCH PLANS RATHER THAN
COMMUNICATION OF RESEARCH AFTER
IT HAS BEEN PERFORMED, SO MOST
RESEARCHERS ARE UNLIKELY TO
UNDERTAKE LINE OF INVESTIGATION
THAT FALLS UNDER DURC,
PARTICULARLY THAT ENTAILS ONE OF
THE SEVEN SELECT EXPERIMENTS ON
ONE OF THE LISTED AGENTS.
TALKING ABOUT TRAINING, WE HAVE
THE INVESTIGATOR, PRINCIPAL
INVESTIGATOR, AND THEN WE HAVE A
HANDFUL OF HANDS-ON RESEARCHERS
IN THE LABORATORY WHO WORK WITH
THEM, I HAVE TO DO A COMPLETE
TRAINING, NOT JUST ON THE AGENT
ALONE, BUT I HAVE TO DO A
TRAINING ON DUAL USE RESEARCH OF
CONCERN, AS I INDICATED EARLIER
THE AGENT IS TRULY NOT DURC
AGENT.
HOWEVER, TRYING TO CONVINCE THEM
TO EXPLAIN TO THEM WHY IT IS
BEING CONSIDERED, WHY DID THE
AGENCY SAY WE HAVE TO CONSIDER
THIS WAY.
THE MORE IMPORTANT PART IS TO
CONVINCE THEM THIS IS NOTHING
WRONG AND SOMEBODY MENTIONED
ABOUT SCIENCE AND TECHNOLOGY
PROGRESSING FASTER THAN OUR
THOUGHTS, THINGS THAT POP OUT OF
UNPRECEDENTED RESULTS, IT'S NOT
THAT WE WANT EVERYBODY TO HALT
EVERYBODY AND DO NO WORK BUT WE
WANT THEM TO BE AWARE OF WHAT IS
HAPPENING, REPORT TO US, SO THAT
WE CAN HANDLE IT SAFELY AND
REPORT TO NIH AND OTHER
AGENCIES.
SO, THAT PART IS CONVINCING
RESEARCHERS AND CONVINCING THE
PUBLIC, BOTH ASPECTS, MORE
IMPORTANT HANDS-ON RESEARCHERS
TO MAKE THEM UNDERSTAND THIS IS
NOT TO HALT RESEARCH, THIS IS
ONLY TO MAKE SURE YOU CAN WORK
SAFELY AND IT IS SAFE FOR THEM
TO WORK WITH AND SAFE FOR THE
ENVIRONMENT AND SURROUNDING
COMMUNITY.
THAT I THINK AS A BIOSAFETY
OFFICER IS CHALLENGING BECAUSE
IN THE MIND OF THE RESEARCHERS
IT'S THE RESULTS COMING OUT, FOR
THEM TO THINK OUT OF THAT BOX
WHAT THEY ARE THINKING, WHAT
THESE MEAN, IS SOMETHING
DIFFICULT IN THE SPEED AT WHICH
THEY WANT TO MOVE THEIR POINTS.
THESE ARE OUR EXPERIENCES AT
EMORY UNIVERSITY HERE.
>> THANK YOU VERY MUCH, KALPANA.
I THINK IT WOULD BE HELPFUL ALSO
FOR THE OTHER SPEAKERS IN THE
DISCUSSION TO TALK ABOUT THE
SAME CHALLENGES THAT YOU
IDENTIFIED BECAUSE THE SYSTEM
DOES START WITH RESEARCHERS,
P.I.s AND PEOPLE IN
LABORATORIES AS THE FIRST LINE
TO DECIDE WHETHER OR NOT THERE'S
THE DURC POTENTIAL IN RESEARCH
SO HELPFUL FOR OTHERS TO BRING
THAT UP AS WELL.
JOE, WOULD YOU LIKE TO GO NEXT?
>> THANK YOU, RACHEL.
I WANT TO THANK THE NSABB AND
OFFICE OF SCIENCE POLICY FOR
INVITING ME TO PARTICIPATE IN
THIS IMPORTANT WORKSHOP.
I WANT TO ADD THAT IT'S REALLY
GREAT TO SEE SO MANY OF MY I'LL
SAY LONGTIME COLLEAGUES FROM OSP
AND NSABB, GOOD TO SEE YOU ALL.
I WOULD LIKE TO SHARE HOW WE'RE
MANAGING DURC RESEARCH AT
UNIVERSITY OF CHICAGO.
AND SHALL I SHARE MY SCREEN?
IS THAT HOW IT SHOULD GO HERE?
ONE SECOND.
SORRY ABOUT THIS.
ALL RIGHT.
SORRY ABOUT THAT.
SO, AGAIN, I JUST WANT TO TELL
YOU ABOUT THE COMPOSITION OF OUR
IRB AND HOW WE DO PROJECT
REVIEWS.
WE BEGIN BY SAYING UNIVERSITY OF
CHICAGO WE HAVE TWO
INSTITUTIONAL BIOSAFETY
COMMITTEES.
WE HAVE A COMMITTEE THAT
OVERSEES THE WORK CONDUCTED ON
THE HYDE PARK CAMPUS, THE MANY,
CAMPUS, AND ANOTHER AT THE
RICKETTS LAB, AND REVIEWS ANY
PROJECT CONDUCTED AT THE
RICKETTS LABORATORY.
HYDE PARK OVERSEES RECOMBINANT
DNA RESEARCH, REQUIRING REVIEW
BY THE IBC BUT EVEN EXPERIMENTS
THAT ARE NOTIFICATION TO IBC AND
EXEMPT EXPERIMENTS.
WE REVIEW PROJECTS THAT PROVE
PATHOGENS, HUMAN, PLANT OR
ANIMAL, AND ALSO REGISTER
PROJECTS THAT INVOLVE WORKING
WITH BIOLOGICAL TOXINS.
WE HAVE AN ONLINE APPLICATION
SYSTEM THAT WE USE TO REGISTER
OUR IBC PROTOCOLS AND REVIEW
IBC PROTOCOLS, ASKING
RESEARCHERS DOING ANY
RECOMBINANT DNA RESEARCH OR ANY
RESEARCH SUBMITTED TO IBC TO
ANSWER QUESTIONS RELATED TO THE
SEVEN EXPERIMENTS OF CONCERN.
AND WE THEN ASK AN EIGHTH
QUESTION, IF ANY QUESTIONS TO
THE FIRST SEVEN EXPERIMENTS OF
CONCERN WITH ANSWERED YES, THE
EIGHTH QUESTION APPEARS AND THAT
ASKS WHETHER OR NOT THAT WORK
HAS ANY POTENTIAL THREAT TO THE
PUBLIC HEALTH OR PUBLIC
SECURITY.
WHAT HAPPENS IS UPSTREAM OF THE
IBC REVIEW THE BIOSAFETY TIME
REVIEWS PROTOCOLS, WHEN WE SEE
SOMETHING WHERE AN INVESTIGATOR
HAS INDICATED YES TO ANY OF
THESE QUESTIONS WE INITIATE A
DIALOGUE.
AGAIN, WE MAKE AN EFFORT TO
EXTEND OUR OVERSIGHT BEYOND THE
AGENTS LISTED IN THE REGULATION.
NOW, AGAIN, THESE ARE THE 15
AGENTS FORMALLY COVERED BY THE
DURC GOVERNMENT POLICY AND
INSTITUTIONAL POLICIES, AND I'VE
HIGHLIGHTED THOSE WITH WHICH
WE'VE HAD DIRECT EXPERIENCE HERE
AT U CHICAGO, WE HAVE ONGOING
TRACES AND PROGRAMS GOING, WE
MONITOR PROJECTS, BUT WE HAD
AVIAN INFLUENZA PROJECT AS WELL
THAT INVESTIGATOR HAS LEFT THE
UNIVERSITY SO WE NO LONGER ARE
OVERSEEING THAT WORK.
NOW, THE IBCs BASICALLY MEET
MONTHLY, WHAT WE'VE DONE IS
CREATED A SUBCOMMITTEE THAT
INCLUDES MEMBERSHIP OF BOTH OF
THESE IBCs TO BASICALLY
OVERSEE THE DURC WORK THAT'S
HAPPENING.
WE HAVE THE TWO CHAIRS OF THE
REGULAR IBC, HYDE PARK AND
SELECT AGENT IBC, A SENIOR
FACULTY MEMBER FROM DEPARTMENT
OF MICROBIOLOGY WHO IS ALSO A
MEMBER AND A DURC PRINCIPAL
INVESTIGATOR.
WE HAVE A JUNIOR FACULTY MEMBER,
A MEMBER OF OUR IBC, OFFICE OF
GENERAL COUNSEL, DIRECTOR OF THE
OFFICE OF LABORATORY REGULATORY
COMPLIANCE WHO OVERSEES AND
MANAGES ADMINISTRATION OF IBC
AND IACUC AT THE UNIVERSITY.
I SIT ON THAT TASK FORCE, I'M
ALSO THE RESPONSIBLE OFFICIAL
FOR OUR SELECT AGENT PROGRAM AND
THE POINT OF CONTACT FOR DUAL
USE RESEARCH OF CONCERN PROGRAM.
SENIOR BIOSAFETY OFFICERS
PARTICIPATE AS MEMBER OF THE
DURC TASK FORCE.
IT'S A DIALOGUE WITH THE
PRINCIPAL INVESTIGATOR, OF
COURSE THE FUNDING AGENCIES
THEMSELVES ARE INVOLVED IN THIS
DIALOGUE.
WE HAVE MY OFFICE, AS WELL AS
IBC AND DURC TASK FORCE WHO ARE
REALLY RUNNING POINT ON
OVERSIGHT OF THESE PROJECTS AT
OUR INSTITUTION.
I THOUGHT IT WOULD BE IMPORTANT
TO SHARE SOME FRAMEWORK FOR OUR
RISK MITIGATION DEVELOPMENT AND
SO THE FIRST STEP IS REVIEW
RESEARCH, VERIFY IT'S DIRECTLY
INVOLVING NON-ATTENUATED FORMS
OR ONE OR MORE OF EXPECT AGENTS,
LISTED AGENTS.
STEP 2 TO ASSESS WHETHER THE
RESEARCH STILL PRODUCES, AIMS TO
PRODUCE OR CAN BE REASONABLY
ANTICIPATED TO PRODUCE ONE OF
THE SEVEN EXPERIMENTAL EFFECTS.
STEP 3 WHETHER RESEARCH MEETS
DEFINITION OF DURC.
STEP 4 TO REVIEW AS NECESSARY
AND REVISE RISK MITIGATION PLAN.
WE USE AS OUR RESOURCE HERE THE
SEPTEMBER 2014 PUBLICATION OF
IDENTIFICATION AND MANAGEMENT OF
DURC RESEARCH.
SOME MITIGATION MEASURES TO
MITIGATE CONCERNS, SOME
PRACTICES MIGHT BE TAKEN INTO
CONSIDERATION, ONE TO CHANGE THE
TIMING MODE OR VENUE OF
COMMUNICATION FOR THE DURC IN
QUESTION.
ANOTHER TO ESTABLISH A MECHANISM
FOR PRE-PUBLICATION OR
PRE-COMMUNICATION REVIEW BY THE
INSTITUTION, AS KALPANA
INTELLECTUAL CAL PAN -- AS
KALPANA POINTED OUT, REDACT
SPECIFIC INFORMATION IN LIGHT OF
SECURITY CONCERNS, SOMETHING WE
ROUTINELY DO WITH ANIMAL
RESEARCH IN ANY CASE FOR
CONCERNS OF ANIMAL RIGHTS
CONCERNS.
THAT'S SOMETHING WE PLAY PAY
CLOSE ATTENTION TO.
VERY IMPORTANT BIWHEN WE
COMMUNICATE, DO RESEARCH OF
CONCERN, EMPHASIZE BIOSAFETY AND
BIOSECURITY MEASURES ESTABLISHED
AND PUT IN PLACE THROUGHOUT THE
COURSE OF THE RESEARCH.
FINALLY WE THINK THAT IT'S
IMPORTANT TO EMPHASIZE THE
PUBLIC HEALTH AND BROADER
SIGNIFICANCE OF DURC AND EXPLAIN
WHY THE WORK IS IMPORTANT AND
HOW IT MAY INFORM THE
DEVELOPMENT OF COUNTER-MEASURES,
DISEASE SURVEILLANCE AND
PREPAREDNESS AS WELL AS RESPONSE
EFFORTS.
NOW, SOME OF THE THINGS THAT ARE
COMMON TO ALL OF OUR RISK
MITIGATION PLANS ARE THE
FOLLOWING.
EACH HAS THEIR OWN UNIQUE ASPECT
OF COURSE BUT THESE ARE THINGS
COMMON TO ALL RISK MITIGATION
PLANS.
FIRST IS THE DESCRIPTION OF THE
ENHANCED BIOSAFETY AND
BIOSECURITY MEASURES IN PLACE,
ALL FORM OF COMMUNICATIONS,
WHETHER MANUSCRIPT PUBLICATION,
ABSTRACT, POSTER PRESENTATION,
CONFERENCE, ET CETERA.
THIS IS SOMETHING THAT WE REALLY
WANT TO PUT FRONT AND CENTER.
WE TRAIN OUR INVESTIGATORS ON
DURC, WHETHER DOING DURC
RESEARCH OR NOT.
THIS IS PART OF OUR STANDARD
BIOSAFETY TRAINING.
WE DO ONGOING MONITOR OF DURC
PROJECTS.
ANOTHER THING WE'VE DONE FOR
SELECT AGENT PROGRAM AGAIN WHICH
INCLUDES DURC WORK IS
INSTALLMENT OF ETHICAL CODE OF
CONDUCT FOR THE WORK AND THIS IS
SOMETHING THAT IS SIGNED
ANNUALLY BY SELECT AGENT
INVESTIGATORS, DISCUSSED POINT
BY POINT WHEN WE DO ANNUAL
INTERVIEWS WITH SELECT AGENT
INTERVIEWS.
LASTLY, ANOTHER ELEMENT COMMON
TO THESE MITIGATION PLANS IS,
AGAIN, TO DISCUSS THE PUBLIC
HEALTH BENEFITS TO BE DERIVED
FROM WORK, THAT SHOULD BE
INCLUDED IN ALL FORMS OF THE
COMMUNICATION ABOUT THAT WORK.
SO NOW THE DURC TASK FORCE
PROVIDES RECOMMENDATIONS ON THE
FOLLOWING.
FIRST, DESIGN AND CONDUCT OF
INVESTIGATORS RESEARCH WITH DURC
TO REQUIREMENT FOR ENHANCED
BIOSAFETY OR BIOSECURITY
MEASURES FOR THAT WORK.
THREE, VERY IMPORTANTLY,
EVALUATION OF THE EXISTENCE OF
MEDICAL COUNTERMEASURES EFFICACY
FOR THE WORK BEING CONDUCTED.
AND THEN FOURTH, EDUCATIONAL
TOOLS ON BIOSECURITY AND DUAL
USE RESEARCH THAT HAVE BEEN
DEVELOPED BY THE NSABB.
SO HOW MUCH OF AN IMPACT HAS
THIS HAD?
IT'S NOT BEEN AN OVERLY I WOULD
SAY INTRUSIVE ACTIVITY,
BASICALLY WE'VE REVIEWED SEVEN
GRANT PROPOSALS, MIGHT HAVE FAN
YOUR SCRIPTS, TEN GRANT
PROPOSALS AND THREE MANUSCRIPTS,
AND THEN IN INFLUENZA PROGRAM WE
HAD SIX GRANT PROPOSALS, WE DID
REVIEWS FOR, AN INVESTIGATOR
LEFT OUR INSTITUTION BEFORE
PUBLISHING.
SO WE HAD NO MANUSCRIPT REVIEW
INVOLVED THERE.
THAT'S REALLY WHERE WE ARE AT,
HOW WE'RE MANAGING OUR DURC
PROGRAM.
I'LL STOP AND THANK YOU FOR
INVITING ME TO PARTICIPATE IN
THIS INTERESTING DISCUSSION AND
LOOK FOR WASHED TO THE REMAINDER
OF THE PROGRAM.
THANK YOU.
>> THANK YOU VERY MUCH, JOE.
IF I COULD JUST ASK, YOU TALKED
ABOUT REDACTION, I WONDERED HOW
THAT RECOMMENDATION IS MADE, WHO
MAKES THE RECOMMENDATION AND HOW
IS IT RECEIVED, IS THAT IS A
DONE IN CONJUNCTION WITH JOURNAL
EDITORS?
>> YES, OBVIOUSLY IT'S SOMETHING
WE WORK CLOSELY WITH THE
PRINCIPAL INVESTIGATOR ON.
AND OF COURSE THE IDEA IS THAT
WHEN YOU PUBLISH, YOU'RE
SUPPOSED TO -- THE PERSON IS
SUPPOSED TO BE ABLE TO REPRODUCE
THAT WORK BASED ON WHAT'S
DESCRIBED.
AND SO THIS IS A DIALOGUE THAT,
YOU KNOW, TO BE HONEST THERE'S
NOT A LOT REDACTED.
I MEAN, IT'S PART OF THE
CONSIDERATION, BUT THAT'S REALLY
SOMETHING CASE BY CASE WITH
INVESTIGATOR AND JOURNAL
EDITORS.
>> THANK YOU VERY MUCH.
SO WE'LL GO ON TO SIMON AND COME
BACK FOR BROADER QUESTIONS TO
THE ENTIRE PANEL.
THANK YOU.
>> I WAS PLEASED YOU PREFACED
THE WAY YOU DID.
I COME FROM A DIFFERENT
PERSPECTIVE, RESEARCHER AT
UC-DAVIS, ENGAGING WITH POLICY
AT DIFFERENT LEVELS.
FUNDAMENTALLY IT STARTS WITH ME,
FORMULATING AND DEVISING GRANTS
AND COMPLIANCE REVIEWS IS A, AND
ENGAGE IN OTHER TYPES OF REVIEWS
COMMITTEES, EVEN NIH STUDY
SECTIONS WHERE SELECT AGENTS ARE
REVIEWED AND DISCUSSED AND GAIN
OF FUNCTION RESEARCH IS
INCREASINGLY BEING HIGHLIGHTED.
I DON'T PERFORM RESEARCH WITH
THE SCOPE OF DURC BUT THE POLICY
IS RELEVANT.
WE FOCUS ON VIRAL DISCOVERY AND
CHARACTERIZATION SO WE'RE
LOOKING FOR AND TRYING TO
CHARACTERIZE UNKNOWN VIRUSES.
AND OFTEN IN BATS AND MANY
SELECT AGENTS ON THE LIST
CURRENTLY ARE VIRUSES THAT HAVE
COME FROM BATS.
WE THINK ABOUT THE SCOPE A FAIR
AMOUNT BECAUSE OF CHANGES TO THE
AGENTS OR EXPERIMENTAL
CONDITIONS CAN SUDDENLY CHANGE
OUR OWN WORK FROM BEING NOT
UNDER THE SCOPE OF DURC TO
SUDDENLY BEING UNDER THE SCOPE.
AND BECAUSE WE'RE WORKING WITH
VIRUSES THAT HAVE UNDEFINED
RISKS, VIRUSES, THIS IS KIND OF
IMPORTANT, VIRUSES FOR WHICH THE
ANSWERS TO MANY OF THESE
QUESTIONS, MANY OF THESE DURC
QUESTIONS ARE LIKELY TO ACTUALLY
BE "I DON'T KNOW" RATHER THAN "
YES" OR "NO," PERHAPS AN
EXPANSION OF SCOPE SHOULD AT
LEAST CONSIDER THIS INCREASING
EFFORT TO CHARACTERIZE VIRUSES,
WILDLIFE, BECAUSE WE FIND NOVEL
VIRUSES THAT FALL INTO THESE
TAXONOMIC GRAY ZONES.
IF YOU FIND EBOLA VIRUS, YOU'LL
SURVEY CLOSE VARIANTS OF THE
EBOLA VIRUS, WHEN IS IT SUDDENLY
NO LONGER EBOLA VIRUS, HOW
DIFFERENT DOES THE NEW VIRUS
HAVE TO BE BEFORE IT SUDDENLY IS
NOT EBOLA AND THEREFORE NOT
UNDER THE DURC POLICY.
THERE'S BEEN GOOD DISCUSSION
ABOUT THE SCOPE AND
IMPLEMENTATION OF DURC, I THINK
THIS IS CRITICALLY IMPORTANT AND
AGREE ON ONE HAND THERE'S
CLEARLY ROOM TO EXPAND LIST OF
AGENTS AND EXPERIMENT
CONDITIONS, BUT ON THE OTHER IT
CREATES INCREASED REGULATORY
BURDEN AND I DO WORRY ABOUT
CHALLENGES THAT IT POSES FOR
FUNDING AND PUBLISHING.
I THINK IN PRACTICE ACTUALLY THE
SCOPE IS ALREADY EXPANDING AND
WE HEARD ABOUT THAT FROM THE
SARS 2 WORK.
AND EVEN BEYOND THAT, THERE'S SO
MUCH FOCUS ON GAIN OF FUNCTION
EXPERIMENTS IN GENERAL, EVEN FOR
AGENTS THAT ARE NOT ON THIS LIST
AT ALL.
IN SOME WAYS I THINK THAT'S GOOD
BECAUSE IT REALLY HIGHLIGHTS THE
VIEW OR FLEXIBILITY BUILT INTO
THE POLICY THAT IT CAN BE
EXPANDED AND USED BEYOND JUST
THE AGENTS, AND THE CONDITIONS
LAID OUT CURRENTLY BUT IN SOME
WAYS IT'S BAD BECAUSE
SPECIFICITY IS AN IMPORTANT
INDICATOR WHAT IS ALLOWED AND
REGULATED AND WHAT IS NOT.
FROM MY PERSPECTIVE AS A
RESEARCHER, CLARITY OVER THE
SCOPE IS REALLY IMPORTANT.
WE WANT TO BE COMPLIANT AND
NAVIGATING THE MANY POLICIES AND
REGULATIONS FOR LIFE SCIENCES
RESEARCH, CAN BE DIFFICULT AS
ALL SORTS OF BIOSAFETY AND
BIOSECURITY PURPOSES THAT HAVE
TO BE NAVIGATED AND SORT OF
INTEGRATED.
I WORRY ABOUT THE ABILITY TO
PUBLIC OR GET GRANTS FOR WORK
THAT CONSTITUTES DURC, WE SHOULD
CONSIDER POTENTIAL FOR REDUCTION
IN RESEARCH ON THOSE AGENTS OR
AT LEAST ON THE WORK THAT COMES
UNDER THAT.
SCOPE CHANGES.
WHAT WAS ALLOWED PREVIOUSLY IS
NO LONGER ALLOWED, THE WORLD HAS
MOVED ON, WE'VE ALSO SEEN
THROUGHOUT THIS PANDEMIC SOME
UNFORTUNATE AND VERY NEGATIVE
DISCUSSIONS AROUND THIS SORT OF
THING.
AS WE LEARN AND CHARACTERIZE
MORE IS IT EXTRA-REGULATORY OR
SHOULD WE REGULATE IBCs AND
ELEVATING BIOCONTAINMENT, FOR
EXAMPLE.
IT'S DIFFICULT TO REGULATE
THINGS ABOUT WHICH WE KNOW
NOTHING, THE THREAT OF THESE
UNKNOWN UNCHARACTERIZED,
UNEMERGED VIRUSES IS SORT OF AN
ONGOING ISSUE.
WE DO A LOT OF VIRAL DISCOVERY,
LOOKING FOR NEW THINGS, OFTEN
NEW VIRUSES IN BATS AND THESE DO
NOT COME UNDER THE CURRENT
DEFINITION.
BATS HOST MANY VIRUSES,
INCLUDING SELECT AGENTS, ON THE
OTHER IT'S A GREAT LEAP TO
SUGGEST ALL OR PERHAPS EVEN THE
MAJORITY OF BAT VIRUSES POSE A
THREAT TO HUMANS.
AND THEN THE VARIANTS, THAT I
MENTIONED EARLY, WHEN IS A TIER
1 VIRUS NOT A TIER 1 VIRUS?
HOW MUCH VARIATION IS THERE
BEFORE SUDDENLY WE'RE EITHER
WITHIN OR UNDER OR NOT UNDER
THIS POLICY?
I ALSO WONDER ABOUT SURROGATE
SYSTEMS.
IN THE PAST WE'VE SORT OF USED
THIS IN A WAY TOO GET AWAY FROM
OR GET AROUND THESE SORTS OF
POLICIES.
YOU KNOW, RATHER THAN DOING
GENETIC MANIPULATION OF
AUTHENTIC VIRUSES DO SURROGATE
SYSTEMS TO INTERROGATE
DETERMINANTS THAT MAY BE
ASSOCIATED WITH PARTICULAR
PHENOTYPES, AND WHILE THAT'S NOT
GENERATING A MORE INFECTIOUS
VIRUS, IT'S STILL GENERATING
INFORMATION THAT ARGUABLY CAN
CONTRIBUTE TO SUCH CONCERNS.
SO AT OUR OWN INSTITUTION AT
UC-DAVIS WE TRIED TO BE
EXPANSIVE IN OUR INTERPRETATION
OF DURC AND BIOSAFETY POLICIES
IN GENERAL, BECAUSE MANY OF THE
VIRUSES THAT WE'RE WORKING WITH,
SAMPLES OR SPECIES, THAT WE'RE
WORKING WITH, ARE
UNCHARACTERIZED.
I THINK IT'S BEEN THE GENERAL
APPROACH TO DOWNGRADE THE RISK
OF UNKNOWN AGENTS BECAUSE
THERE'S NO SPECIFIC INFORMATION
THAT ELEVATES THEM TO A HIGHER
RISK CATEGORY.
BUT WE TEND TO START WITH SORT
OF ASSUMPTION OF HIGHER RISK,
UNTIL WE KNOW OTHERWISE.
WE TRY TO BE A BIT MORE AGNOSTIC
IN THAT SENSE, AND WHEREVER WE
CAN WE IMPLEMENT RISK MITIGATION
PRACTICES OR ACCORDINGLY, SO WE
MAY PROCESS INFECTIOUS --
POTENTIALLY INFECTIOUS SAMPLES,
DIAGNOSTIC SAMPLES FROM BATS IN
A BSL3 UNTIL ACTIVATED, MAY
PERFORM EXPERIMENTS AT BSL3 EVEN
IF NOT OFFICIALLY CLASSIFIED AS
BSL3, LYSIS BATH IN THE FIELD,
BIG PROCESS WHETHER OR NOT WE
EVEN NEED POTENTIALLY INFECTIOUS
SAMPLE, CAN WE MITIGATE THAT
RISK RIGHT AT THE BEGINNING?
I ALSO THOUGHT THAT THE EARLIER
COMMENTS ABOUT TRAINING WERE
IMPORTANT AND INSIGHTFUL.
OFTEN THE TRAINING AROUND THIS
IS LIMITED TO PEOPLE IN
PROGRAMS, SO IT'S ONLY THOSE
PEOPLE THAT DO UNDERSTAND, AT
LEAST UNDERSTAND THE BEST, THE
RISKS THAT WE'RE TALKING ABOUT.
SO, WHILE THIS IS NOT
NECESSARILY AN INSTITUTIONAL
THING, IN MY OWN GROUP WE HAVE
SOME PEOPLE WHO ARE SORT OF BSL3
AND SOME PEOPLE THAT DON'T,
MAKING SURE EVERYONE IS FULLY
AWARE OF SORT OF THE DISTINCTION
AND WHAT CONTRIBUTES TO RISK AND
ELEVATES TO CERTAIN RISK
CATEGORIES IS IMPORTANT FOR THE
COMMUNICATION AND THAT WAS
MENTIONED EARLIER.
I THINK I WILL END MY COMMENTS
THERE.
THANK YOU.
>> THANK YOU SO MUCH.
YOU'VE GIVEN US QUITE A BIT OF
FOOD FOR THOUGHT.
WE DO NEED TO GO TO BROADER
QUESTIONS BUT IF I COULD ASK JOE
AND KALPANA FROM THEIR
PERSPECTIVE BEING PEOPLE ON THE
FRONT LINE OF THE IBCs, WHAT
YOUR EXPECTATION MIGHT BE AT THE
IMPACT ON RESEARCH IF SCOPE WERE
BROADENED IN SOME WAY, GENERALLY
SPEAKING, IF YOU COULD QUICKLY
JUST ADDRESS THAT.
>> SO, I CAN BEGIN.
YEAH, I THINK, YOU KNOW, I THINK
THAT IF SCOPE IS BROADENED THEN
THE PROCESS HAS TO BECOME MORE
FORMALIZED.
I THINK THAT DOES OBVIOUSLY
REQUIRE ADDITIONAL EFFORT, ON
BOTH OF THE PART OF THE
INVESTIGATOR AND THE COMMITTEES.
AGAIN, THAT BEING SAID, WE DO
TRY TO GET IN FRONT OF THAT AND
TRY TO, YOU KNOW, TAKE THIS
APPROACH WHERE THIS IS
CONSIDERED FOR ALL OF OUR WORK
BUT WE DON'T OBVIOUSLY
NECESSARILY HAVE TO DEVELOP
MITIGATION PLANS, ET CETERA.
I THINK IF SCOPE WERE EXPANDED
WE WOULD HAVE TO THINK ABOUT
WHAT DO WE REALLY NEED TO
MONITOR, TO PUT IN PLACE, TO
MONITOR AND MANAGE THESE
EXPANDED PROJECTS.
BECAUSE I DO THINK, AGAIN, IT
DOES REQUIRE ADDITIONAL LABOR ON
THE INVESTIGATOR AND THE
COMMITTEES.
>> I WOULD LIKE TO ADD TO WHAT
JOE SAID.
THEY DEFINITELY GIVES US AN
OPPORTUNITY TO EXPAND THE SCOPE
SINCE MOST OF OUR INSTITUTION
BIOSAFETY COMMITTEE, MEMBERS ARE
RESEARCHERS, HANDS-ON
RESEARCHERS, INVESTIGATORS.
WE HAVE OCCUPATIONAL, IN OUR
SYSTEM, OCCUPATIONAL HEALTH
SYSTEM, SERVING ON THE
COMMITTEE.
REVIEWED PROTOCOLS, BASED ON
THINGS COMING LIKE THIS, IT
MAKES THE COMMITTEE BROADEN
THEIR THOUGHT PROCESS THAT THEY
SHOULD THINK ABOUT THIS WAY FOR
THIS AGENT, MAKE IT A MORE
ROBUST SYSTEM, NOT NECESSARILY
UNKNOWN AGENTS BUT EVEN FOR
KNOWN AGENTS THAT WE APPROVING,
WILL THAT BE A LITTLE BIT --
SHOULD WE BE MORE STRINGENT?
THAT GIVES US AN OPPORTUNITY TO
EXTRAPOLATE OUR OWN THOUGHT
PROCESS BASED ON WHAT WE'RE
BEING ASKED TO DO ON THIS
SEGMENT
>> GERRY AND DENNIS.
>> THANK YOU.
THANKS FOR ALL THE COMMENTS.
I WANT TO GO BACK TO SOMETHING
JILL SAID IN THE FIRST PANEL,
PARAPHRASING, ESSENTIALLY THE
WAY DURC STARTED WITH THE LIST
OF 15 SPECIFIC SELECT AGENTS,
SEVEN CATEGORIES OF EXPERIMENTS,
IS NECESSARY, THE FOUNDATION.
BUT I THINK JILL SAID IT'S NOT
SUFFICIENT.
I THINK WE HEARD THAT IN THESE
PRESENTATIONS, I APPRECIATED
SIMON'S COMMENTS ABOUT VIRAL
DISCOVERY AND CHARACTERIZATION,
IN THAT, VIRAL ECOLOGY.
WE'RE GETTING INTO UNCERTAIN
TERRITORY.
YOU'RE ARGUING FOR BOTH SIDES OF
THE EQUATION, DO WE NEED
ADDITIONAL GUIDANCE, DO WE NOT?
I REALLY THINK WHAT I WAS
HEARING, THE RESEARCHERS WHO ARE
DOING THIS WORK NEED CLEAR
GUIDANCE, CLEAR GUIDANCE.
IN FACT, THERE IS AN ARGUMENT
THAT WE DO NEED TO EXPAND THE
SCOPE TO INCORPORATE THIS
UNCERTAIN TERRITORY.
THAT'S WHY WE'RE CHALLENGED, HOW
DO WE DO THAT?
AND MY QUESTION, HOW DO WE DO
THAT?
WHAT'S THE TERMINOLOGY?
IS IT REALLY -- WE'VE GOT TO
MOVE BEYOND THIS SPACE, WE'VE
GOT TO THINK ABOUT HOW WE'RE
GOING TO DO THE VIRAL
CHARACTERISTICS AND DEAL WITH
THE UNCERTAIN TERRITORY IN A WAY
THAT YOU HAVE CLEAR GUIDANCE AS
A RESEARCHERS AND WE MITIGATE
THE RISK.
>> YEAH, I DON'T KNOW WHICH IS
COMPLETELY USELESS FOR YOU.
I'M FULLY AWARE, I DON'T KNOW
NECESSARILY WHAT THE RIGHT
ANSWER IS.
I MEAN, YOU KNOW, YOU MAY LOOK
AT THESE LISTS OF AGENTS AND
EXPERIMENTS AND THINK, WELL, YOU
KNOW, I'M DOING THIS ONE
EXPERIMENT, OVER HERE, SO I
WOULD TICK A BOX ON THE
EXPERIMENTAL PART.
WHEN I LOOK BACK TO THE LIST I'M
NOT ON THE LIST.
SO I'M NOT OFFICIALLY UNDER
THIS.
I HAVE A FEELING IT'S THIN
NUANCED LINE YOU'RE DEALING
WITH.
AND SO THERE'S A CERTAIN
UNCOMFORTABLE FEELING THAT GOES
ALONG WITH THAT WORK, AND IN
MANY WAYS THIS GREATER
EXPANSIVE VIEW, I THINK WOULD
HELP WITH THAT, RIGHT?
BECAUSE IT WOULD CAPTURE SOME
OTHER AGENTS THAT CLEARLY ARE
IMPORTANT BECAUSE WHY ARE WE
LOOKING AT THEM IF NOT?
BUT, YEAH, I DON'T KNOW IF I
HAVE THE SOLUTION.
>> THANK YOU.
THREE PEOPLE HAVE HANDS UP.
DENNIS, WOULD YOU LIKE TO GO
NEXT?
AND THEN JILL AND JIM AND WE
NEED TO GO TO THE PUBLIC
COMMENTS.
>> THANKS, EVERYBODY, FOR VERY
USEFUL TALKS.
I'VE LEARNED A LOT OF THINGS,
OPEN FOR DISCUSSION BY NSABB.
ONE THING THAT I WONDER ABOUT,
MAYBE JOE COULD ADDRESS THIS,
YOU DESCRIBED A DETAILED
PROCEDURE FOR A TASK FORCE,
DEVELOPMENT OF A TASK FORCE,
REVIEW OF RESEARCH, MANUSCRIPTS.
MY QUESTION IS, HOW WERE THOSE
PROCEDURES DEVELOPED?
I'VE BEEN AT MULTIPLE
INSTITUTIONS, FILLED OUT
MULTIPLE IACUC FORMS, THEY SEEM
TORE SIMILAR FROM INSTITUTION TO
INSTITUTION BUT WHEN IT CAME TO
IBC FORMS IT SEEMED LIKE THERE
WAS NO UNIFORM TYPE OF REVIEW
AND IN FACT PRETTY MUCH DEPENDED
ON WHO HAPPENED TO BE THE
RESPONSIBLE OFFICIAL AT THE TIME
AND AT MY LATEST INSTITUTION
WE'VE GONE TO MULTIPLE ROs,
WONDERING WERE THOSE PROCEDURES
MANDATED BY SOME GOVERNMENT
AGENCY OR DID YOU DEVELOP THOSE
PRETTY MUCH ON AN AD HOC BASIS?
>> YEAH, IT'S MORE THE LATTER,
DENNIS.
YOU KNOW, I JUST -- AS WE
THOUGHT ABOUT WHO GETS THEIR
HANDS ON OVERSEEING THE WORK,
RIGHT?
AT WHAT POINT IS THE WORK
REVIEWED?
AND IT HAPPENS OBVIOUSLY AT THE
P.I. LEVEL, FIRST AND FOREMOST,
IT HAPPENS AT THE UNIVERSITY
RESEARCH ADMINISTRATION, WHERE
GRANTS WITH TRANSMITTED AND
FUNDS ARE DISBURSED.
THERE ARE AGREEMENTS SIGNED ON
ALL OF THOSE THINGS.
SO I THINK WE FELT THAT IT WAS
VITAL THAT GROUP BE INCLUDED.
OBVIOUSLY, THE IBCs AND
BIOSAFETY OFFICERS, AND THE
FEDERAL AGENCIES GET THEIR HANDS
ON IT.
WE THOUGHT WHETHER WHO IS
INVOLVED IN THE MANAGEMENT
PROCESS.
AND THAT'S REALLY KIND OF HOW WE
FOCUSED.
I THINK THE ESTABLISHMENT OF
TASK FORCE WAS THE IDEA THAT WE
WOULD BRING IN THE EXPERTISE NOT
ONLY OF SELECT AGENT RESEARCHERS
BUT OTHERS AS WELL.
AGAIN, I THINK GOING BEYOND THE
LIST IS PART OF THE THINKING
THERE.
>> DO YOU THINK IT WOULD BE
USEFUL FOR THIS COMMITTEE TO
DEVELOP SOME KIND OF UNIFORM
PROCEDURE FOR IBC REVIEW?
>> YEAH, IT'S A GREAT QUESTION.
THAT MIGHT BE CHALLENGING.
I THINK ANOTHER THING WE'VE
DEVELOPED THAT'S BEEN HELPFUL,
ONLINE REGISTRATION PROCESS AND
SYSTEM.
NOT ONLY IS THE PROCESS USED BY
INVESTIGATORS TO DESCRIBE THE
WORK THEY ARE DOING AND
CONTAINMENT MEASURES, ET CETERA,
BUT IT'S ALSO THE SYSTEM INBY
WHICH REVIEWERS LOG THEIR
COMMENTS.
SO THE PROJECTS UPDATE GO
MULTIPLE LEVELS OF REVIEW.
THEY ARE INITIALLY REVIEWED BY
ADMINISTRATIVE OFFICE OF IBC,
THEN BY THE BOTH SAFETY OFFICE
TEAM AND FINALLY THE COMMITTEE.
A LOT OF WORK, A LOT OF
INFORMATION, IF IT'S NOT ALREADY
IN THE PROTOCOL IT'S OBTAINED
BEFORE THE PROTOCOL HITS THE
COMMITTEE SO THAT TO MOVE THINGS
ALONG AND EXPEDITE THINGS.
BUT I THINK IT'S THAT DIALOGUE
THAT OCCURS IN THAT ENTIRE
PROCESS, THAT, YOU KNOW, HELPS
US MONITOR AND HELPS EDUCATE THE
FACULTY ABOUT THE WORK WE'RE
TRYING TO DO HERE.
>> YES, JILL, WOULD YOU LIKE TO
GO NEXT?
>> MY QUESTION REALLY IS FOR
SIMON.
THE GRAY AREA THAT HE'S WORKING
IN, AND SO BUT BATS ARE A
RESERVOIR OF VIRUSES, A
FANTASTIC AND INCREDIBLY --
COULD BE A FORMATIVE AREA, AND
SOMETHING WE LOOKED AT BECAUSE
OF THE RESERVOIR OF BATS FROM
THE RABIES PROGRAM.
BUT ONE THING THAT YOU CAN DO IS
KEEP IN TOUCH WITH YOUR PUBLIC
HEALTH LAB, IS THIS A SEQUENCE
THEY SHOULD BE LOOKING FOR?
PERHAPS DEVELOP THE DESIGNER PCR
ASSAY SO WE HAVE THE TOOLS READY
IF WE NEED THEM.
AND THIS IS PART OF THE
COMMUNICATION AND TRANSPARENCY
IF IT GOES TO GENBANK IS THERE
SOME NOTATION THAT SAYS HAS THE
POTENTIAL FOR HUMAN
TRANSMISSION, YOU KNOW, THE MORE
INFORMATION, THE BETTER.
BUT AS YOU KNOW, I'M SORT OF ALL
ABOUT PREPAREDNESS AND READINESS
AND HAVING THE TOOLS READY FOR
DEVELOPMENT OF TEST, WE'RE ONE
STEP AHEAD, SO JUST A THOUGHT.
>> YES, THANK YOU.
>> OKAY.
AND THERE WAS ONE MORE.
JIM, OF COURSE.
>> THANK YOU.
THIS HAS BEEN A GREAT
CONVERSATION.
I KNOW WE'RE RUNNING SHORT ON
TIME.
QUICK POINTS, NUMBER ONE, I
THINK THE DIVERSITY OF
PRESENTATIONS FROM THIS GROUP
DEMONSTRATES THE QUALITY OF
IBCs THAT ARE ALREADY IN
PLACE.
I WAS PLEASED WITH DENNIS'
COMMENT THAT WHAT SEEMS TO BE
LACKING IS SET OF NORMS AND
STANDARDS THAT EVERYBODY ASPIRES
TO, ONE OF THE POINTS I WAS
TRYING TO MAKE EARLIER THAT THE
GOVERNMENT COULD HELP BY
ABSOLUTELY ESTABLISHING THAT.
THAT SAID, WE DON'T TALK AT ALL
ABOUT THE DYI COMMUNITY, THE
GROUPS THAT JILL AND MARIA SO
ELOQUENTLY TALKED ABOUT.
THAT'S THE REAL CHALLENGE, HOW
DO WE GET OUT OF THIS ACADEMIC
RESEARCH ENVIRONMENT AND ENGAGE
THE BROADER COMMUNITY THAT NEEDS
OUR INVOLVEMENT.
I REALLY ENJOYED SIMON'S
PRESENTATION.
I THINK HE'S ALSO WORKING IN A
CUTTING EDGE AREA THAT WE NEED
TO PAY SOME ATTENTION TO.
AND SO IN HIS LINE OF RESEARCH,
WHERE DO YOU DRAW THE LINE AND
HOW DO YOU ADDRESS THE RISKS
ASSOCIATED FIRST WITH SEQUENCES,
ONLY NON-INFECTIOUS MATERIAL
GOING TO ISOLATION OF POTENTIAL
PATHOGENS OR VIRUSES,
CHARACTERIZATION OF THOSE
ESPECIALLY TRANSMISSIBILITY, ARE
YOU GOING TO DO CHIMERIC WORK TO
TEASE OUT AND IDENTIFY, THESE
ARE THE QUESTIONS TO ADDRESS
GOING FORWARD.
WE DON'T HAVE TIME NOW TO TALK
ABOUT EACH OF THOSE BUT I WOULD
HOPE THE NSABB STARTS LOOKING
FOR SERIOUSLY AT THAT AS IT
RECONVENES.
THANK YOU.
>> THANK YOU.
REALLY GOOD POINTS.
WE NEED YOUR LIST TO KEEP IN
MIND AS WE GO FORWARD WITH ANY
REVISIONS AND UPDATES TO THE
CURRENT POLICY BECAUSE I THINK
WHAT YOU'VE IDENTIFIED BASED ON
WHAT SIMON HAS SHOWN TO BE THIS
GRAY AREA IS REALLY IMPORTANT
THAT WE CAPTURE THAT.
WE'RE PERFECT ON TIME, GIVEN AN
EXTRA FEW MINUTES.
I SEE LYRIC JORGENSON BACK ON.
>> THANK YOU.
BEFORE WE BEGIN, I WOULD LIKE TO
OPEN UP THE FLOOR FOR THE PUBLIC
COMMENT PORTION OF THE MEETING.
WE'RE WORKING TO FIGURE OUT WAYS
TO ENGAGE STAKEHOLDERS IN THE
CONVERSATION, EVEN IF YOU'RE NOT
PROVIDING PUBLIC COMMENT DURING
THIS PORTION OF THE MIDEASTING
WE WELCOME OUR COMMENTS AT ANY
TIME IN WE WELCOME YOUR COMMENTS
THROUGH OUR SITE.
THIS IS NOT THE ONLY THING WE'RE
SEEKING COMMENTS.
AT ANY MOMENT IN TIME WE'RE
LOOKING THEM.
BEFORE WE START LET'S TURN THIS
OVER TO CARLY SULLIVAN, TEAM AT
PALLADIAN, MODERATING THIS
PORTION.
TAKE IT AWAY.
>> THANK YOU.
WE HAVE ADMITTED PUBLIC
COMMENTERS.
RICHARD IS FIRST.
WE'LL HAVE A TIMER SET.
WE'LL START THAT WHEN YOU'RE
READY TO GIVE YOUR FIRST
COMMENT, THREE MINUTES.
YOU'LL BE ABLE TO SEE THAT ON
THE SCREEN, AS A ZOOM SQUARE.
WHEN THE TIMER IS COMPLETE,
PLEASE WRAP UP YOUR COMMENTS.
OTHER THAN THAT I WILL HAVE
RICHARD UNMUTE AND TAKE THE
FLOOR.
WE CAN START THE TIMER.
>> THANK YOU FOR THE OPPORTUNITY
TO COMMENT.
LAPSES IN OVERSIGHT MAY HAVE
CAUSED THE CURRENT PANDEMIC AND
COULD CAUSE FUTURE PANDEMICS.
U.S. GOVERNMENT FUNDED HIGH RISK
DUAL USE VIRUS DISCOVERY
RESEARCH, HIGH RISK DUAL USE
GAIN OF FUNCTION RESEARCH OF
CONCERN AND ENHANCED POTENTIAL
PANDEMIC RESEARCH AT WUHAN
INSTITUTE IN 2016 THROUGH 2019.
THE RESEARCH OVERLAPPED THE
PAUSE AND MET CRITERIA TO BE
PAUSED BUT WAS NOT PAUSED.
RESEARCH OVERLAPPED FRAMEWORK
INVOLVING ENHANCED PANDEMIC
PATHOGENS THAT MET THE CITE.
BIOSAFETY LEVEL 2 IS INADEQUATE,
MAY HAVE ENCOUNTERED OR CREATED
SARS-COV-2 OR PROXIMAL
PROGENITOR, AN ACCIDENT MAY HAVE
BEEN RESPONSIBLE FOR ENTRY OF
SARS-COV-2 INTO THE HUMAN
POPULATION.
THESE FACTS AND THESE STATEMENTS
ARE FACTS, INDICTMENT OF THE
CURRENT SYSTEM OF OVERSIGHT OF
DUAL USE RESEARCH OF CONCERN AND
ARE A TESTAMENT THAT NEW SYSTEM
OF OVERSIGHT IS ESSENTIAL.
MOVING FORWARD ANY EFFECTIVE
SYSTEM OF DUAL USE RESEARCH OF
CONCERN MUST ADDRESS FIVE
SHORTCOMINGS.
FIRST, CURRENT FEDERAL OVERSIGHT
OF DUAL USE RESEARCH IS
PERFORMED BY FEDERAL AGENCIES.
RESPONSIBILITIES SHOULD BE
ASSIGNED TO A SINGLE AGENCY THAT
DOES NOT PERFORM RESEARCH AND
DOES NOT FUND RESEARCH.
SECOND, CURRENTLY ALMOST NO DUAL
USE RESEARCH EVER CONCERN EVEN
VERY HIGH RISK IS REVIEWED AT
THE FEDERAL LEVEL.
FOR REFERENCE IN THE SIX YEARS
SINCE THE P3CO FRAMEWORK ONLY
THREE PROJECTS UNDERWENT FEDERAL
LEVEL RISK/BENEFIT REVIEW.
OTHER HIGH RISK PROJECTS
INCLUDING THOSE IN WUHAN DID NOT
UNDERGO FEDERAL LEVEL
RISK/BENEFIT REVIEW.
INSTEAD, CURRENTLY REVIEW IS
DELEGATED TO RESEARCHERS AND
INSTITUTIONS, CONFLICT OF
INTEREST, DIFFICULT TO ENSURE
NATIONAL SECURITY ARE ADDRESSED.
THE ENTIRE HIGH RISK SUBSET OF
DUAL USE RESEARCH OF CONCERN
MUST BE REVIEWED AT THE FEDERAL
LEVEL.
THIRD, CURRENT LIST OF 15
PATHOGENS SUBJECT TO DUAL USE
RESEARCH OF CONCERN IS
INCOMPLETE, DOES NOT INCLUDE
CORONAVIRUS.
FOURTH, ONLY FEDERAL FUNDING,
THOSE NOT RECEIVING FUNDING ARE
NOT COVERED, IT SHOULD COVER ALL
INSTITUTIONS.
MOVING FORWARD OVERSIGHT AND
COMPLIANCE FOR DUAL USE RESEARCH
OF CONCERN SHOULD BE CODIFIED
WITH FORCE OF LAW.
COMPLIANCE FOR HUMAN SUBJECTS
RESEARCH ALREADY ARE CODIFIED IN
REGULATIONS WITH FORCE OF LAW.
THANK YOU.
THANK YOU, NEXT WE HAVE DAVID
LOVECCHIO, YOU'RE FREE TO
UNMUTE.
R. AND START.
>> THANK YOU FOR THE OPPORTUNITY
TO SPEAK.
CAN YOU HEAR ME?
>> YES.
>> OKAY.
>> IN MAY 2010 YouTube
VIDEO, DUAL USE RESEARCH OF
CONCERN, A DIALOGUE, JONATHAN
TRUCKER, Ph.D., SAID THE CASE
OF NUCLEAR PHYSICS THERE WAS
ICONIC MOMENT, MUSHROOM CLOUD
THAT MADE IT CLEAR THAT THEIR
WORK ARE SECURITY IMPLICATIONS,
THERE'S BEEN NO COMPARABLE
EXPERIENCE FOR LIFE SCIENCE.
I WOULD SAY THAT'S NO LONGER THE
CASE.
AND I WOULD SUGGEST THAT IN
ADDITION TO EVERYTHING THAT
RICHARD SAID WHICH I WOULD ECHO
I WOULD SAY ANY RESEARCH BEING
DONE WITH ENHANCED PATHOGEN
LIKE MERS SHOULD BE
CONSIDERED -- CONSIDER MOVING TO
ISOLATED ENVIRONMENT AND NOT
HAVE THAT RESEARCH TAKE PLACE IN
A DENSELY POPULATED CITY WITH AN
INTERNATIONAL AIRPORT.
I THINK THAT WOULD BE A GREAT
REASSURANCE TO THE PUBLIC THAT'S
CONCERNED ABOUT THIS SORT OF
WORK AND AS A MEMBER OF THE
PUBLIC I INCLUDE MYSELF IN THAT
CATEGORY.
I THINK THAT THERE WAS A MENTION
ABOUT EXEMPTION TO MORATORIUM
INFLUENCED BY OBAMA ON GAIN OF
FUNCTION RESEARCH, FOR
ECO-HEALTH ALLIANCE AND I THINK
IN THAT CASE THAT THE CONTRACTOR
ECO-HEALTH WAS ALLOWED TO CRAFT
LANGUAGE USED TO BE PUT INTO THE
CONTRACT TO ALLOW THE EXEMPTION,
I DON'T THINK THAT SHOULD REALLY
EVER BE THE CASE AND I THINK
THAT IF THAT HAS BEEN DONE, AND
THIS SHOULD APPLY TO YOU IN ANY
CASE WHETHER THAT'S DONE OR NOT,
THAT A FAILURE TO MEET
CONTRACTUAL OBLIGATION SHOULD
HAVE REPERCUSSIONS.
AND WHEN YOU GET A LOGARITHMIC
GROWTH THAT WOULD REQUIRE YOU TO
REPORT AND YOU DON'T, THERE
SHOULD BE CONSEQUENCES FOR THAT.
ASIDE FROM THAT, AS A MEMBER OF
THE PUBLIC, WITH AN OPPORTUNITY
TO COMMENT ON THIS, I DON'T KNOW
WHAT THE FEEDBACK MECHANISM IS
FOR WHETHER MY COMMENTS HAVE HAD
ANY SORT OF IMPACT OR IF THERE'S
ANY -- I DON'T KNOW WHAT IS
DONE.
AM I JUST TALKING INTO A CHASM
AND NOTHING COMES FROM IT?
I THINK THERE SHOULD BE SOME WAY
OF KNOWING THAT THESE COMMENTS
HAVE BEEN TAKEN INTO ACCOUNT.
I WOULD LIKE TO ASK IF ANY
PUBLIC COMMENT BEFORE IN A
SESSION LIKE THIS HAS HAD IMPACT
ON POLICY THAT'S BEEN CRAFTED.
IT WOULD BE GOOD TO KNOW WE'RE
NOT JUST INVITED TO VENT.
AND THAT'S THE EXTENT OF MY
TIME.
SO THANK YOU.
>> THANK YOU.
AND NEXT WE HAVE ANTHONY, I SAW
YOU ON THE LINE.
WE CAN RESTART YOUR TIMER AND
YOU ARE FREE TO COME ON CAMERA
AND SPEAK.
>> AM I ON CAMERA?
>> PERFECT, YES.
>> SO WE NORMALLY THINK OF LAB
WORK, IMPORTANT STUFF, BUT
COVID-19 HAS KILLED 20 MILLION
PEOPLE.
IT'S A GLOBAL DISASTER.
AS A RESULT WE DO NOT MEET
BINARY REQUIREMENTS FOR LAB
RESEARCH, WHAT'S REQUIRED IS
COMPLETE OVERHAUL OF HOW
RESEARCH IS CONDUCTED INVOLVING
MANDATORY AND PUBLIC EXTERNAL
REVIEWS.
CONSIDER THIS.
HUMANITY WILL BE MUCH BETTER OFF
IF THERE HAD BEEN ZERO RESEARCH
IN VIROLOGY OVER THE LAST 20
YEARS, NONE OF THE BENEFITS
COMES CLOSE TO MATCHING THE
MASSIVE DISASTER THAT IS
COVID-19.
SO ZERO RESEARCH WOULD BE BETTER
THAN COVID-19.
THAT SOUNDS RADICAL BUT QUITE
TRUE.
FURTHER, SEARCHING FOR UNKNOWN
VIRUSES PROVIDED NO HELP IN
DEALING WITH THE PANDEMIC.
THE POLITICAL WINDS ARE
SHIFTING.
ANY FAIR INVESTIGATION OF THE
ORIGINS OF COVID-19, SARS 2
APPEARED IN A CITY IN CHINA, THE
WORLD'S LEADING LABORATORY FOR
THE BAT CORONAVIRUS, THE CITY IS
A THOUSAND MILES FROM RELEVANT
BATS, NO OTHER SOURCE THAT BE
IDENTIFIED DESPITE RESEARCH.
THE LABORATORY EVEN HAD A
RESEARCH PROPOSAL TO WRITE A
NOVEL SITE TO CORONAVIRUS, THE
LAB BECAME SECRETIVE AND
DESTROYED EVIDENCE.
COMMON SENSE SAYS IT WAS
OBVIOUSLY A LAB LEAK, PEOPLE ARE
TRYING TO BE POLITICALLY
CORRECT, OBVIOUSLY A LAB LEAK
BEYOND REASONABLE DOUBT,
CERTAINLY TO THE MEMBERS OF THE
PUBLIC LIKE MYSELF.
IF THE BECOMES WIDELY ACCEPTED
THERE WILL BE OUTRAGE.
I WOULD ADVISE SCIENTIFIC
COMMUNITY TO ADDRESS THIS BEFORE
THAT HAPPENS.
NOT JUST FUNDING IN THE USA BUT
ALL RESEARCH GLOBALLY.
SARS 2 WAS RELATIVELY MILD.
IMAGINE AN EQUALLY CONTAGIOUS
VIRUS WITH A LONG INCUBATION
APPEARED THAT ATTACKED THE
IMMUNE SYSTEM, A WONDERFUL
RESEARCH PROBLEM.
IT WOULD HAVE BEEN IMPOSSIBLE A
FEW YEARS AGO BUT TODAY THERE
ARE THOUSANDS OF RESEARCHERS
THAT HAVE ACCESS AND EQUIPMENT
TO PRODUCE SUCH A VIRUS, IT MUST
BE TIGHTLY CONTROLLED.
WE DO NOT WANT THIS TO HAPPEN
AGAIN.
THIS IS IMPORTANT.
AND URGENT.
I DON'T GET THAT SENSE OF
URGENCY FROM COMMENTS OF OTHER
VIROLOGISTS.
THIS MAJOR DISASTER REQUIRES
MAJOR REFORM.
THANK YOU.
>> WE NOW HAVE AARON JONES ON
THE LINE, YOU ARE NEXT IF YOU'D
LIKE TO UNMUTE AND COME ON
CAMERA.
WE'LL START THE TIMER FOR YOU.
DO WE HAVE AARON JONES?
>> HELLO?
CAN YOU HEAR ME?
>> YES.
>> ALL RIGHT.
>> GREAT.
THANK YOU.
I JUST HAD A COUPLE COMMENTS
ABOUT THE MENTION OF DURC.
FIRST, THE CONCERN ASPECT, WHEN
THE CONCERN COMES TO THE FRONT I
THINK THAT IT SHOULD INCLUDE A
DEMOGRAPHIC CONCERN, INCLUDING
THOSE THAT ARE IRRATIONAL.
FOR EXAMPLE, IN THE E.U. WE SEE
THAT GMOs ARE REGULATED, NOT
BY SCIENTIFIC CONCERN BUT BY
CONCERNS FROM THE GENERAL
PUBLIC.
IN THE SAME WAY, I THINK THAT
CONCERNS ABOUT -- HELLO?
CHECK CHECK.
>> YES, WE CAN STILL HEAR YOU.
>> OKAY, YEAH.
IN THE SAME WAY I THINK THE
CONCERNS ABOUT GAIN OF FUNCTION
EXPERIMENTS, ET CETERA, SHOULD
BE AN ISSUE, EVEN IF THEY ARE
NOT SCIENTIFIC BUT ARE CONCERNS
FROM THE GENERAL PUBLIC, WHICH
WE SEE AS A MAJOR CONCERN OVER
THE LAST TWO YEARS.
SO, THERE'S THAT.
AND SECOND OF ALL, I THINK THAT
THE DEFINITION OF GAIN OF
FUNCTION AND DURC DOES NOT
INCLUDE EXPERIMENTS THAT, FOR
EXAMPLE, AMPLIFY A REALLY SMALL
HAPLOTYPE OR WHATEVER IT IS, A
REALLY SMALL VARIANT THAT -- SO,
FOR EXAMPLE, DROSTIN IN EUROPE
FOUND THAT THERE WAS A SCS
POTENTIAL IN A VIRUS, AND IF HE
WAS TO COPY THAT AND CREATE IT
THAT WOULDN'T BE INCLUDED UNDER
DURC GUIDELINES BECAUSE IT'S
NATURAL.
AND I'VE SEEN THIS IN
(INDISCERNIBLE) WHERE IF IT'S
NATURAL IT'S OKAY TO AMPLIFY
IT.
THE THING IS AMPLIFICATION IS IN
ESSENCE DIFFERENT.
>> THANK YOU.
YOUR TIMER HAS RUN OUT.
IF YOU HAVE CLOSING THOUGHTS
PLEASE WRAP UP AND WE'LL MOVE ON
TO THE NEXT COMMENTARY.
IF PAUL SYKES IS ON THE LINE,
PLEASE TURN ON YOUR CAMERA.
YOU'RE OUR FINAL COMMENTER.
UNMUTE YOURSELF AND WE'LL START
THE TIMER FOR YOU.
>> THANKS FOR THE OPPORTUNITY TO
MAKE A FEW COMMENTS.
I THINK FOR ME THIS PANDEMIC IS
THE GREATEST DISASTER IN THE
LAST CENTURY.
YOU KNOW, TRANSPARENCY FOR ME IS
THE KEY WHEN IT COMES TO THE
NIH.
THE NIH IS A PUBLICLY FUNDED
ORGANIZATION, WITH TAX MONEY
FROM THE PUBLIC.
AND THE GOAL IS TO LOOK AFTER
THE HEALTH OF THE PUBLIC.
AND FOR ME, MOST IMPORTANT THING
AT THE MOMENT IS TO GET TO THE
BOTTOM OF THE ORIGINS OF THIS
VIRUS.
YOU KNOW, TRANSPARENCY IS KEY,
ESPECIALLY FOR AN ORGANIZATION
LIKE THE NIH, WE'RE GOING TO
LOOK BACK AT ALL THE INFORMATION
REQUESTS AND WHAT IS HAPPENING
AROUND THE TIME THE VIRUS
STARTED AROUND THE WORLD, AND
ALL WE GOT FROM THE NIH WAS A
LOT OF REDACTED E-MAILS,
SCIENTISTS THAT WERE INVOLVED IN
DEVELOPING STRATEGY TO COMBAT
AND TO ADDRESS COVID DISCERN
(INDISCERNIBLE) AROUND THE U.S.
AND WORLD, I HAVE SUSPICIONS WAS
MADE IN A LABORATORY IN THE
WUHAN, AND SUBSEQUENT TO THAT
PUT OUT A STATEMENT CALLING IT
THE SUGGESTION THIS CAME OUT OF
A LAB IS A CONSPIRACY THEORY, I
THINK THAT'S PAINTED THE THE
VIROLOGY COMMUNITY IN A BAD
LIGHT, THAT PAPER THAT WAS
PUBLISHED, I JUST THINK IT'S
SHOCKING THE NIH HASN'T BEEN
TRANSPARENT.
EVEN THE (INDISCERNIBLE)
REDACTED, WHAT IT IS, IT SPEAKS
TO THE WHOLE ISSUE OF DUAL USE
RESEARCH, SUGGESTS THAT THE
INTELLIGENCE COMMUNITY
(INDISCERNIBLE) ORGANIZATIONS
LIKE THE NIH HAVE BEEN USING
POTENTIALLY -- WE CAN ONLY
SPECULATE, USING THE NIH TO, YOU
KNOW, CONDUCT COVERT ACTIVITIES
IN CHINA, WITHIN WUHAN,
(INDISCERNIBLE) AND I THINK IT'S
TIME FOR THE NIH TO COME CLEAN,
TO UNREDACT THOSE E-MAILS,
VENTILATE EVERYTHING AND GET IT
OUT IN THE OPEN AND SO WE
DON'T -- WE CAN AVOID THIS THING
HAPPENING AGAIN.
AS I SAID AT THE VERY BEGINNING,
WE DON'T KNOW WHAT CAUSED THIS
PANDEMIC, HOW ARE WE GOING TO
PREVENT THE NEXT ONE?
THE OTHER THING I DON'T THINK IS
ANY MERIT IS PROPOSED POURING
BILLIONS OF DOLLARS INTO
PREDICTIVE MODELS, SPENDING
MONEY ON GAIN OF FUNCTION
RESEARCH.
I DON'T BELIEVE GAIN OF FUNCTION
RESEARCH HAS ANY NARRATIVE
PREVENTING FUTURE PANDEMICS, FOR
ALL WE KNOW MAY CAUSE THE
CURRENT PANDEMIC.
SO I THINK THE NIH NEEDS TO BE
TRANSPARENT.
IT'S A PUBLIC ORGANIZATION,
FUNDED BY PUBLIC MONEY, AND WHY
SHOULD THEY BE ALLOWED TO HIDE
BEHIND REDACTED E-MAILS.
THOSE ARE MY COMMENTS.
I THINK THERE ARE LOTS OF
CONFLICTS OF INTEREST WITHIN THE
NIH.
THERE SHOULD BE AN INDEPENDENT
COMMITTEE OR AGENCY THAT LOOKS
INTO THESE -- THIS KIND OF
RESEARCH AND HOLDS THOSE
RESEARCHERS ACCOUNTABLE FOR WHAT
THEY DO AND AGREE WE NEED TO PUT
IN STRICTER GUIDELINES AND NEED
TO BE MONITORED MORE VIGOROUSLY
SO THIS DOESN'T HAPPEN AGAIN.
THANK YOU VERY MUCH.
>> THANK YOU, PAUL.
LYRIC, I'M GOING TO TURN IT BACK
TO YOU TO ANNOUNCE THE BREAK AND
GIVE US NEXT STEPS.
>> THANKS, CARLY.
THANK YOU TO EVERYONE WHO TOOK
THE TIME TO PROVIDE PUBLIC
COMMENTS TODAY.
YOUR THOUGHTS, PERSPECTIVES AND
OPINIONS ARE CRITICALLY
IMPORTANT.
WE DON'T HAVE TIME TO ADDRESS
ALL THE CONVERSATION TODAY, I
WOULD LOVE TO ADDRESS THE ONE
COMMENT ABOUT HOW PUBLIC
COMMENTS ARE USED IN THE POLICY
PROCESSES.
I KNOW THIS IS HAS BEEN AN
IMPORTANT CONSIDERATION.
WIRE NOT SPEAKING INTO A VACUUM.
PUBLIC COMMENT IS INCORPORATED
INTO ALL WE DO AT NIH.
YOU'LL SEE WORK GOING OUT TO
ISSUE PUBLIC COMMENT, IN
POLICIES WE FORM THERE'S A
SECTION IN THE BEGINNING THAT
SAYS HERE'S WHAT WE HEARD FROM
YOU ALL, HERE IS HOW WE
ADDRESSED IT IN THE POLICY.
PLEASE REST ASSURED ALL PUBLIC
COMMENTS ARE CONSIDERED AND
TAKEN SERIOUSLY REGARDLESS OF
PERSPECTIVE.
THANK YOU FOR TAKING TIME TO
SHARE THOUGHTS.
WE HAVE TIME FOR A BREAK.
I THANK CARLY FOR TAKING OVER
MODERATING THAT SESSION AND WE
WILL TAKE A BREAK UNTIL 3:05
WHERE WE'LL RESUME FOR THE FINAL
COMPONENT.
THANK YOU SO MUCH.
WELCOME BACK.
I WOULD LOVE TO SEE OUR THIRD
AND FINAL PANEL TODAY TURN ON
THE CAMERAS FOR THE FINAL
SESSION, THINKING ABOUT THE
FUTURE.
I'M DELIGHTED TO BE JOINED BY A
GREAT PANEL TODAY, DAVID GILLUM
HAS 25 YEARS OF EXPERIENCE
LEADING SAFETY AND COMPLIANCE
ACTIVITIES AT SEVERAL ACADEMIC
RESEARCH TEACHING AND PUBLIC
SERVICE INSTITUTIONS.
ASSISTANT VICE PRESIDENT EVER
ENVIRONMENTAL HEALTH AND SAFETY,
ARIZONA STATE UNIVERSITY, ALSO
CHIEF SAFETY OFFICER WITH SAFETY
OVERSIGHT RESPONSIBILITY FOR
NEARLY 3,000 LABORATORIES,
SHOPS, STUDIOS, MAKERSPACES AND
MORE.
2020 PRESIDENT OF ABSA
INTERNATIONAL.
NEXT DR. CHRIS VIGGIANI, OREGON
STATE UNIVERSITY, OVERSEEING
COMPLIANCE PROGRAMS.
PRIOR TO JOINING OSU CHRIS RAN
AND LED THE TEAM OF BIOSAFETY
AND BIOSECURITY POLICY AT NIH,
OFFICE OF SCIENCE POLICY,
EXTENSIVE EXPERIENCE IN
LABORATORY SAFETY, SECURITY
EXECUTIVE DIRECTOR OF NSABB.
FINAL SPEAKER IS DR. JENNIFER
KUZMA, DISTINGUISHED PROFESSOR
AT SCHOOL OF PUBLIC AND
INTERNATIONAL AFFAIRS,
CO-FOUNDER AND CO-DIRECTOR OF
GENETIC ENGINEERING AND SOCIETY
CENTER, NORTH CAROLINA STATE
UNIVERSITY.
PRIOR TO HER POSITION WAS
ASSOCIATE PROFESSOR AT HUMPHREY
SCHOOL OF PUBLIC AFFAIRS,
UNIVERSITY OF MINNESOTA, STUDY
DIRECTOR AT NATIONAL ACADEMIES
OF SCIENCE, ENGINEERING AND
MEDICINE, AND WAS AAAS RISK
POLICY FELLOW, USDA, WORKING IN
RISK ASSESSMENT FOR FOOD BORNE
PATHOGENS.
WE'RE DELIGHTED TO HAVE OUR
PANELISTS HERE.
I'LL START BY HEARING FROM
MR. GILLUM.
>> THANK YOU ALL VERY MUCH FOR
HAVING ME TODAY.
I FIRST WANT TO SAY I'M SORRY
WE'RE NOT IN PERSON.
BUT I ACTUALLY CAME DOWN WITH
SOMETHING THAT'S BEEN GOING
AROUND IN THE COMMUNITY, AND
IT'S PROBABLY FOR THE BEST THAT
WE'RE NOT TOGETHER.
I'D LIKE TO THANK THE NIH, THE
OFFERS OF SCIENCE POLICY AND
WOULD LIKE TO THANK A DEAR
COLLEAGUE AT THE NIH OFFICE OF
SCIENCE POLICY, KATHERINE
HARRIS, FOR SUGGESTING I BE
HERE.
KATHERINE, YOU'RE IN MY THOUGHTS
ALWAYS.
I'M GOING TO JUMP RIGHT IN.
ONE OF THE THINGS FOR THIS
PRESENTATION WAS TO TRY TO THINK
HIGH LEVEL AND WHAT THE FUTURE
MIGHT LOOK LIKE.
I LIKE DOING THAT BUT I WANT TO
THINK HOW DO WE BALANCE THE
RISKS OF DOING THAT AND IMPROVE
OVERSIGHT MECHANISMS TO HELP
ENSURE NON-COMPLIANCE.
I WANT TO JUST GO HIGH LEVEL AND
HELP PEOPLE REALIZE IN POLICY
CIRCLES WHEN I'M INVITED TO
MEETINGS I'M OFTEN TOLD A DUAL
US ISSUE WILL BE SOLVED BY A
BIOSAFETY PROFESSIONAL, TO HELP
US FIGURE IT OUT AND THEY WILL
SAVE THE DAY.
AS WE'VE HEARD FROM MARIA
CHAVEZ, THAT'S NOT ALWAYS THE
CASE.
SOME DON'T HAVE PROFESSIONALS
LET ALONE DON'T HAVE PEOPLE WHO
NECESSARILY ARE THINKING ABOUT
BIOSECURITY.
I THINK PEOPLE ARE THINKING
ABOUT IT, I JUST DON'T THINK
IT'S REALLY AS WELL DEFINED AS
IT SHOULD BE.
WE'RE ALSO ASKED TO ANTICIPATE
THE FUTURE.
AND I PUT IN SOME IDEAS THAT I'M
CONCERNED ABOUT, THINGS I SAW
THAT LYRIC HAD INCLUDED IN HER
EARLIER SLIDES ABOUT MAYBE OTHER
REGULATORY OVERSIGHT MECHANISMS,
DIY BIOGENOME MODIFICATIONS,
INCLUDING ON YOURSELF, NATURAL
OUTBREAKS, ENDEMICS, PANDEMICS,
PUBLICATIONS WITH UNFORESEEN AND
ADVERSE CONSEQUENCES, AND I'VE
BEEN THINKING ABOUT SYNTHETIC
VIRUSES, VIRUS LIBRARIES AND
POSSIBILITY OF CREATING DE NOVO
VIRUSES OF UNKNOWN RISK.
LASTLY, A BIGGER TOPIC,
UNCERTAIN FUTURE OF THE
BIOLOGICAL WEAPONS CONVENTION.
I THINK ALL OF THESE TOGETHER,
THERE'S A LOT ON OUR PLAYBOOK,
WE COULD TRY TO TACKLE ANY ONE
AND WOULD DO GOOD FOR THE FUTURE
BUT TODAY WE'RE SPECIFICALLY
TALKING ABOUT DURC.
SO, I'D LIKE TO HAVE AN
OVERARCHING HIERARCHY FOR THIS
CONVERSATION TO SAY WE HEARD
FROM UNIVERSITY OF CHICAGO, FROM
KALPANA, THERE'S A LOT OF PLACES
WITH GOOD SYSTEMS FOR OVERSIGHT.
BUT THAT'S NOT THE CASE
EVERYWHERE.
AND SO THE QUESTION REALLY NEEDS
TO BE HOW WILL INSTITUTIONS
JUSTIFY THE RESOURCES NEEDED TO
SUPPORT DURC RESEARCH ESPECIALLY
WHEN IT'S NOT CLEAR HOW MANY
TIMES DURC HAS BEEN MISUSED,
DURC RESEARCH HAS BEEN MISUSED.
I THINK HAVING A BETTER
UNDERSTANDING OF THE RISK WILL
HELP INFORM BETTER DECISION
MAKING.
PUBLIC COMMENTS WERE
ENLIGHTENING, THERE DOES NOT TO
BE BETTER TRANSPARENCY BUT
PEOPLE AREN'T OPERATING WITH
SINISTER MOTIVES AT LEAST NOT IN
ACADEMIC INSTITUTIONS.
I THINK JUST TRYING TO
UNDERSTAND WHERE RISKS ARE SO WE
CAN ACTUALLY BUILD GOOD SYSTEMS
WOULD BE HELPFUL.
ANOTHER TOPIC THAT IS NEVER
DISCUSSED, WHO IS CULPABLE IF
SOMETHING GOES WRONG?
SELECT AGENT WORLD RESPONSIBLE
OFFICIAL, P.I., ANYONE INVOLVED
COULD FACE TEN YEARS IN PRISON,
$250,000 IN FINES, THAT COULD BE
THE INSTITUTION.
IT'S BEEN A WHILE, I HAVE A
BRAIN THAT'S ILL, SO TAKE MY
WORD FOR IT THE FEDERAL SELECT
AGENT PROGRAM HAS PENALTIES.
THE THE QUESTION IS SHOULD DURC
HAVE POTENTIAL PENALTIES IF
SOMEONE DOES SOMETHING WRONG AND
WHO IS REQUIRED TO FOLLOW
GUIDANCE?
WE HEARD THIS IS FOR
GOVERNMENT-FUNDED RESEARCH BUT
IS THAT FAIR?
IS THAT EVEN -- HOW IS THAT
GOING TO CAPTURE EVERYTHING?
DREW ENDY TALKED ABOUT HOW
MONEY, WE HAVE SYSTEMS TO
CONTROL WITH MONEY, MAYBE IT'S A
LARGE PORTION BUT IT'S NOT
EVERYTHING.
LASTLY IS THERE A SIMPLER BETTER
WAY TO OVERSEE RESEARCH?
FOR EXAMPLE DOING MORE AT
RESEARCHER OR INSURER TUITIONAL
LEVEL AND TO THE PUBLIC
COMMENTERS COULD WE BE MORE
TRANSPARENT TO MAKE SURE THEY
ARE INVOLVED AND UNDERSTAND
WHAT'S HAPPENING.
THE NEXT TWO SLIDES, WE WERE
ASKING TO SAY DIFFERENT
MECHANISMS BY WAY SAFETY
OVERSIGHT OR SAFETY GOVERNANCE
TAKES PLACE.
AND THERE'S REGULATIONS, SUCH AS
SELECT AGENT PROGRAM, BLOODBORNE
PATHOGENS, GUIDELINES LIKE NIH
GUIDELINES FOR COMMENTING ON
RESEARCHE BMBL THAT EVERYONE
MENTIONED, PROS AND CONS FOR
EACH ONE.
I GO FURTHER AND TALK ABOUT
RADIATION SECURITY, I DO THINK
IT'S FUNNY, DREW MENTIONED
BUILDING CODES, THIS IDEA OF
BIOCODE BECAUSE THAT'S ONE OF
THE -- VOLUNTARY CON CONSENSUS,
AND AAALAC FOR ANIMAL CARE AND
OTHER STANDARDS LESS USED IN THE
UNITED STATES.
THIS WAS TALKED ABOUT DURING
OTHER TALKS, WE ASK THESE
QUESTIONS, SEVEN OR EIGHT
QUESTIONS ACTUALLY, ASK THEM OF
EVERY RESEARCH PROJECT THAT
COMES TO THE IBC.
IT'S MORE ABOUT THE EXPERIMENT
AND THEN WE DECIDE IS IT REALLY
A RISK AND WHAT ARE
IMPLICATIONS?
DOES IT FALL UNDER DURC?
THAT'S THE CONVERSATION, IF YES,
WORKING WITH AGENTS, BUT WE ALSO
HAVE RESEARCHERS WORKING WITH
VIRUSES THAT ARE CLOSELY ALIGNED
WITH SMALLPOX.
IT'S BETTER TO ASK QUESTIONS OF
EVERY EXPERIMENT JUST TO GET THE
CONVERSATION GOING, HAVING
PEOPLE TALK ABOUT IT LIKE
STARTING TO THINK ABOUT WHAT ARE
THE RISKS OF POTENTIAL USE FOR
EVERY EXPERIMENT, IT DOESN'T
MEAN EVERYTHING STOPPED OR SLOWS
DOWN THE PROCESS IN ANY WAY.
JUST OPENS A DIALOGUE FOR PEOPLE
TO TALK ABOUT IT.
FOR THE FUTURE, I ASK US TO
CONSIDER ABCDs, ANTICIPATE
UNANTICIPATED CONSEQUENCES OF
FUTURE DURC OVERSIGHT, BUILD
CAPACITY AND DEVELOP CONCISE
SCOPE.
WE NEED TO CONSIDER WHO MAY
BENEFIT FROM FUTURE DURC RULES.
SOME SAY THE PUBLIC, THERE MAY
BE PEOPLE WITH SELF-INTERESTS
THAT YOU MAY NOT THINK ABOUT
RIGHT AWAY.
THOSE WHO MAY EXPERIENCE
DIFFICULTY WITH THE FUTURE
OVERSIGHT.
THE SELECT AGENT PROGRAM LED
MANY TO LEAVE RESEARCH BECAUSE
IT BECAME TOO EXPENSIVE AND
DIFFICULT AND BURDEN SOME, I
WOULD HATE TO SEE THAT HAPPEN.
LIFE SCIENCES ARE GOING SO FAST
IT WOULD BE BAD TO YOU THE
APPROXIMATE THE BRAKES ON SOME
THINGS.
OVERSIGHT SHOULD PROVIDE FOUND
OF FUNDING FOR COMPLIANCE
STRUCTURES, IBCs, BIOSAFETY
OFFICERS, BSL3 AND 4, EVEN BSL2
FACILITIES, SAFETY AND STAFFING.
WE SHOULD CONSIDER IMPACT OF
PUBLISHING DELAYS FOR DURC
REVIEW AND PUBLICATIONS.
BUILD BIOSECURITY EXTRA
CAPACITY, PRACTITIONERS ARE
INEFFICIENT IN -- INSUFFICIENT
IN NUMBER.
WE DON'T HAVE A STANDARDIZED
KNOWLEDGE BASE AND IT REQUIRES
ON THE JOB TRAINING TO FULLY
IMPLEMENT.
THERE AREN'T GREAT PROGRAMS THAT
TREAT PEOPLE HOW TO BE AN EXPERT
WHEN THEY REACH THE JOB MARKET.
SO THAT'S AN AREA THAT NIH COULD
HELP FILL.
AND THE GOOD PHILANTHROPIC
ORGANIZATIONS SHOULD PROVIDE
FUNDING TO INCREASE OUTREACH,
TO IMPROVE SKILL SETS FOR
SCIENTISTS AND PRACTITIONERS IN
THE LIFE SCIENCES RESEARCH
ESPECIALLY DURC.
COMPOSE CLEAR DEFINITIONS.
THE DURC EXPERTS SHOULD MEET TO
MONITOR POTENTIAL EXPERIMENTS OF
CONCERN, THAT WAS MENTIONED
EARLIER IN SEVERAL TALKS.
AND ALERT REGULATED COMMUNITY AS
WARRANTED.
A LOT OF THOUGHT, I DO WONDER IF
LISTING AGENTS IS THAT HELPFUL
SINCE THEY ARE SELECT AGENTS, WE
ALREADY HAVE TO JUMP THROUGH
HOOPS FOR SELECT AGENT RESEARCH.
TO HAVE US DO THAT AGAIN AND
ONLY FOCUS ON THOSE SEVEN
EXPERIMENTAL QUESTIONS FOR THOSE
SEEMS LIKE YOU'RE TYING OUR
ARMS.
IT SEEMS MORE IMPORTANT ASKING
THE QUESTIONS ABOUT DUAL USE
ASPECT OF EXPERIMENTS.
AGAIN, HAVING TOO MUCH
BUREAUCRACY WITH SELECT AGENT
RESEARCH AND DURC OVERSIGHT
SEEMS OVERKILL.
NIH SHOULD DEFINE BIOSECURITY.
YOU HAVE DEFINED IT BUT IT
SHOULD BE MORE PUBLICIZED TO
DISTINGUISH FROM BIOSAFETY.
PEOPLE NEED TO UNDERSTAND THESE
ARE DIFFERENT TOPICS, WITH
DIFFERENT EXPERTISE AND
DIFFERENT PEOPLE WHO TRY TO
IMPLEMENT THEM.
AND DEVELOP CONCISE SCOPE, KEEP
THE SEVEN QUESTIONS, ENCOURAGE
RESEARCHERS TO ANSWER THEM,
PRIORITIZE CAPACITY BUILDING,
ADVANCE BIOSECURITY TRAINING FOR
RESEARCH AND SHOULD STANDARDIZE
A DURC REVIEW PROCESS FOR
PUBLISHERS.
I KNOW THIS LAST ONE IS HUGE BUT
I THINK IT'S REALLY IMPORTANT
THAT WE HAVE THE STANDARD FOR
HOW WE'RE DOING PUBLICATIONS AND
NIH SHOULD HAVE A SEAT AT THE
TABLE WHEN TALKING THROUGH WHAT
SHOULD THAT PROCESS LOOK LIKE.
THE OPPORTUNITIES, I DO THINK
NIH COULD SPEND SOME MONEY
FUNDING BIOSECURITY CENTERS OF
EXCELLENCE.
THESE COULD BE NOVEL, COULD HELP
US PREVENT FUTURE PANDEMIC OR AT
LEAST DOCUMENT THE PROCESSES TO
SAY WHAT'S BEST PRACTICE IN
PANDEMICS OR IN ANY ENDEMIC OR
ANY OUTBREAK OR WHATEVER.
FUND ACADEMIC INSTITUTIONS TO
INSURE BIOSECURITY CURRICULUM
AND BIOSECURITY INTERCURRICULUM,
BEYOND NORMAL THINGS, COMPUTER
SCIENCES AND PREDICTIVE
ANALYSIS, TRYING TO DEVELOP
NOVEL VIRUSES AND THINGS LIKE
THAT.
AND THIS IS PROBABLY TONGUE IN
CHEEK BUT THE GOVERNMENT NEEDS
TO FUND AND STAFF GOVERNMENT
AGENCIES TO PROVIDE BIOSECURITY
INFORMATION, TRAINING AND
OUTREACH TO THE REGULATED
COMMUNITY.
YOU CAN'T JUST PUT OUT A
REGULATION AND NOT HAVE GUIDANCE
THAT GOES ALONG WITH IT.
YOU HAVE TO HAVE TRAINING, THAT
MEANS GETTING INTO THE COMMUNITY
AND INTERACTING WITH
INSTITUTIONS DOING THE WORK.
LASTLY, ALL BIOLOGICAL RESEARCH
IS DUAL USE.
CLEARLY ARTICULATING CONCERN OF
DURC AND HOW TO ADDRESS IT IS
CRITICAL.
THERE COULD BE NEGATIVE IMPACTS
OF DURC GOVERNANCE FIT -- FIT
DOESN'T -- -- AND MUST KEEP UP
WITH SCIENTIFIC ADVANCES.
SORRY I'M SWEATING.
>> SORRY YOU FEEL ILL.
APPRECIATE YOU'RE ABLE TO JOIN
US TODAY, AND THAT YOU RAISED
DEFINITION OF THE DURC POLICY
WHICH IS ABOUT THE DIRECT MISAP
PLAGUES AND ONE OF THE
CLARIFYING QUESTIONS I WANTED TO
ASK YOU, YOU WERE TALKING ABOUT
SOME PENALTIES, AGAIN, DOING
RESEARCH, AT THE END OF THE DAY
PENALTY FOR MISUSE OF DURC OR
MISUSE OF THE RESEARCH IS THE
PENALTY THE PUBLIC WILL FACE,
CARRYING THE WEIGHT OF
MISAPPLICATION.
THE QUESTION I WANT YOU TO
CLARIFY GIVEN THE BOTTOM-UP
CULTURE OF RESPONSIBILITY HOW
WOULD YOU PROPOSE INSTANTIATING
THE PUBLIC COST THINKING THROUGH
THE JUSTIFICATION OF THE BURDEN
OF OVERSIGHT, WHAT ARE YOUR
THOUGHTS ABOUT THOSE TRADEOFFS?
>> YEAH, I GUESS I WOULD TAKE --
WOULD CHALLENGE YOU TO SAY THAT
THE POTENTIAL FINES I FACE AS A
RESPONSIBLE OFFICIAL MAKE ME DO
THINGS MORE THOROUGHLY AND I'M
NOT GOING TO -- I'M MORE
CAREFUL, RIGHT?
IF THERE WAS POTENTIAL FOR CHEAT
TO DURC, IF YOU MISUSE
SOMETHING, YOU OR YOUR
INSTITUTION TO BE FINED, DO I
KNOW THAT'S THE RIGHT ANSWER?
NOT AT ALL.
I'M NOT SURE IT IS.
WHY DO WE DO IT FOR SELECT
AGENTS BUT NOT DURC?
FLIP SIDE, I'M MORE IN FAVOR OF
WHAT MARIA CHAVEZ WAS SAYING,
BOTTOM-UP APPROACH INVOLVING THE
COMMUNITY, INVOLVES THE
STAKEHOLDERS WE HEARD FROM
RECENTLY, WHO ARE PASSIONATE
ABOUT THEIR VIEWS ON THE ORIGINS
OF COVID, FOR EXAMPLE, EVEN
THOUGH I MAY NOT SHARE THEM,
THESE CONVERSATIONS ALLOWING
PEOPLE TO TALK ABOUT THEM AND
ABOUT A SYSTEM BENEFICIAL FOR
THE HUMAN RACE, THAT'S HUGELY
IMPORTANT.
WHAT THAT LOOKS LIKE IS PROBABLY
MEETINGS, CONFERENCES, BRINGING
PEOPLE TOGETHER, IT'S BEING
RESPECTFUL, SHARING THESE IDEAS,
AND INCLUDING THEM IN THE
POLICY-MAKING PROCESS.
YOU NEED A LOT OF VOICES.
SOMEBODY AT THE BEGINNING, I
DON'T REMEMBER WHO, SAID YOU
NEED PEOPLE FROM -- THE
GENTLEMAN ON THE AIRPLANE, SAID
YOU NEED PEOPLE FROM MANY
VOICES.
I COULDN'T AGREE MORE.
I THINK ANYTIME I DO SOMETHING,
WHEN I WRITE ABOUT BIOSAFETY OR
BIOSECURITY, I THINK OF MY
MOTHER.
WILL SHE UNDERSTAND THIS?
WILL SHE HAVE A CLUE WHAT I'M
TALKING ABOUT?
OR IS SHE GOING TO SAY MY CRAZY
SON, I LOVE HIM BUT I DON'T KNOW
WHAT HE'S TALKING ABOUT.
WE NEED PEOPLE, WE PUT OURSELVES
IN THEIR CHOOSE AND LEARN TO
COMMUNICATE IN A WAY THAT THEY
UNDERSTAND.
AND SO I DON'T KNOW IF THAT
ANSWERS YOUR QUESTION BUT THAT'S
WHAT I WOULD SAY.
>> THANK YOU SO MUCH.
LOOK FORWARD TO DISCUSSING THAT
MORE.
DR. VIGGIANI, WE'LL TURN IT OVER
TO YOU.
>> THANK YOU, LYRIC.
THANKS, EVERYONE.
THIS HAS BEEN A REALLY
INTERESTING CONVERSATION.
I'VE BEEN PART OF DOZENS OF
STAKEHOLDERS MEETINGS BUT IT'S
WEIRD TO BE ON THIS SIDE OF THE
PANEL.
THE CONVERSATION THIS MORNING
HAS BROUGHT BACK A LOT OF GOOD
MEMORIES, REMINDING ME OF THE
TENSION WITH THIS ISSUE BETWEEN
THE THEORETICAL AND PRACTICAL.
HOW IN THEORY WE HAVE IDEAS BUT
IN PRACTICE NAILING DOWN THE
RULES AROUND IT, IN A SENSIBLE
WAY IS CHALLENGING.
TODAY WHAT I WANTED TO DO WAS
TALK A LITTLE BIT ABOUT THE
FUTURE OF DURC, FROM AN
INSTITUTIONAL PERSPECTIVE.
I THINK YOU'RE SEEING THAT.
>> YEP.
>> AND I THOUGHT I WOULD BREAK
DOWN THE CONVERSATION IN A
COUPLE WAYS, TWO PARTS.
FIRST WILL FOCUS ON GENERAL RISK
ASSESSMENT AND COMPLIANCE IN
HIGHER EDUCATION.
GENERALLY HOW WE THINK ABOUT
IDENTIFYING RESEARCH-RELATED
RISKS AND SET INSTITUTIONAL
PRIORITIES AND MOVE IN TO TALK
ABOUT SPECIFIC CONSIDERATIONS
FOR THE FUTURE OF DURC OVERSIGHT
AND LEVERAGE BIOSAFETY, CONTROLS
AND OUTREACH.
FOR A QUICK SNAPSHOT OREGON
STATE, A LAND GRANT INSTITUTION
IN CORVALLIS, THREE CAMPUSES, 11
COLLEGES, HEAVILY AGRICULTURAL
BUT HAVE A NUMBER OF COLLEGES
THAT ARE RESEARCH HEAVY.
TOP RESEARCHERS DOING CLIMATE
SCIENCE, WE HAVE ENGINEERING
COLLEGE DOING CUTTING EDGE WORK
ON ARTIFICIAL INTELLIGENCE, TOP
FORESTRY COLLEGE IN THE WORLD,
AS WELL AS A WHOLE RANGE OF LIFE
SCIENCES RESEARCH THROUGHOUT OUR
OTHER COLLEGES.
WHEN WE THINK ABOUT COMPLIANCE
IN SUCH A BROAD AND DECENTRALIZE
THE UNIVERSITY LANDSCAPE AS OSU,
WE THINK ABOUT UT INSTITUTIONAL
COMPLIANCE, AT A HIGH LEVEL.
I'VE STOLEN THIS SLIDE FROM THE
COMPLIANCE DIRECTOR, HIGHER ED
IS HIGH HE WILL REGULATED.
COMPLIANCE IS COMPLEX AND
CROSS-CUTTING.
SO I MIGHT HIGHLIGHT THE COLUMN
OF RESEARCH RISKS, THAT I
USUALLY FOCUS ON IN MY POSITION.
BUT THERE'S A NUMBER OF OTHER
COMPLIANCE AREAS THAT CAN BECOME
RESEARCH ISSUES, IF IT INVOLVES
RESEARCHERS.
SAFETY OF MINOR IS NOT A
RESEARCH ISSUE UNLESS
VOLUNTEERING IN THE LABORATORY
IN THE SUMMER.
WE START TO WORRY ABOUT THAT.
WHEN WE THINK ABOUT RISK AT THE
INSTITUTIONAL LEVEL, WE WORRY
ABOUT OUR MISSION, FILL FULL OUR
MISSION, IS IT SOMETHING WE'RE
DOING OR NOT DOING THAT IS
PREVENTING US FROM ACHIEVING OUR
CORE RESEARCH MISSION?
WE THINK ABOUT HUMAN HEALTH AND
LIFE SAFETY, PROTECTING OUR
PEOPLE, STUDENTS, EMPLOYEES,
WORRY ABOUT ANIMAL WELFARE
PROTECTING ANIMALS IN OUR
RESEARCH STATION, ABOUT
INTEGRITY, PROMOTING HONEST AND
ETHICAL BEHAVIOR AMONG NOT JUST
RESEARCHERS BUT EMPLOYEES
BROADLY.
THERE'S LEGAL AND REGULATORY
RISKS, WHERE THE DURC POLICY
COMES IN, IN PART.
WE WANT TO ENSURE COMPLIANCE
WITH EXISTING REGULATIONS AND BE
ABLE TO ADAPT AS THOSE
REGULATIONS CHANGE.
THERE'S FINANCIAL RISK AND WE
WANT TO BE GOOD STEWARDS OF
UNIVERSITY RESOURCES, MOST
RESOURCES FOR RESEARCH COME FROM
TAXPAYERS, WE WANT TO PREVENT
WASTE, FRAUD, ABUSE THE BEST WE
CAN.
THERE'S REPUTATIONAL RISKS,
PUBLIC RELATIONS, THIS IDEA WE
WANT TO PROMOTE VALUES TO ENSURE
THAT OSU REMAINS RESPECTED AND
DESIRABLE PLACE FOR PEOPLE TO
COME, TO SEND THEIR KIDS TO
LEARN, FOR FACULTY TO COME AND
DO RESEARCH.
INSTITUTIONAL COMPLIANCE IS
ABOUT SETTING UP THE POLICIES,
PROCESSES, PROGRAMS THAT MANAGE
ALL OF THESE RISK AREAS.
YOU CAN SEE IT'S RESEARCH
FOCUSED, INSTITUTIONS ACROSS THE
COUNTRY THINK IN SIMILAR WAYS.
TO ASSESS RISKS AND PRIORITIZE
ACTIVITIES IT CAN BE TOP-DOWN
AND BOTTOM-UP.
WE HAVE A BOARD OF TRUSTEES AND
UNIVERSITY PRESIDENTS, SETTING
PRIORITIES, ESPOUSING OUR
VALUES.
WHEN THEY SAY WE WANT TO BEEF UP
TITLE 9, THAT MESSAGE TRICKLES
TO APPROPRIATE DIVISION, TO THE
UNITS, AND WE BOLSTER THOSE,
TYPICALLY WITH RESOURCES.
THERE'S A BOTTOM-UP APPROACH TO
RISK ASSESSMENT.
BELOW THE PRESIDENT, THE
COMMITTEE CHAIRED BY PROVOST,
INCLUDING OTHER VICE PRESIDENTS,
UNIVERSITY COMPLIANCE DIRECTOR,
AUDIT, GENERAL COUNSEL AND
OTHERS.
THIS GROUP IS THE TOP LEVEL
COMPLIANCE GROUP THAT THINKS
ABOUT INSTITUTIONAL LEVEL RISK
AREAS, AND HELPS TO SET
PRIORITIES TO SOME DEGREE.
AGAIN, THIS IS BROAD COMPLIANCE,
THESE ARE SOME COMPLIANCE AREAS
THAT I PUT ON THE PREVIOUS SLIDE
THAT MIGHT INVOLVE THINGS LIKE
TITLE 9, HUMAN RESOURCES, SAFETY
OF MINORS, A WHOLE RANGE OF
THING NOT NECESSARILY RESEARCH.
BELOW THAT RESEARCH RISK AND
COMPLIANCE COMMITTEE TO RUN BY
OUR VICE PRESIDENT OF RESEARCH,
INCLUDES ME, OTHER VICE
PRESIDENTS, AVPs FROM RELEVANT
AREAS, AND WE THINK ABOUT
RESEARCH-SPECIFIC RISKS, IT'S
IMPORTANT TO HEAR VOICES FROM
ENVIRONMENTAL HEALTH AND SAFETY,
IMPACTING THE WAY WE SEE
OVERREACH.
AND THE PROGRAMS THAT I OVERSEE
IN MY OFFICE, OUR CORE
COMPLIANCE AND INTEGRITY
FUNCTIONS.
OUR IRB, IACUC, IBC, GLOBAL
ENGAGEMENT AND COMPLIANCE
COMMITTEE.
THESE GROUPS ARE DEVOTED TO
MANAGING THE PROGRAMS, MANAGING
SPECIFIC RISKS ASSOCIATED WITH
PROTEOMIC COLTS -- PROTOCOLS AND
PROGRAMMATIC ASSESSMENT AND
IMPROVEMENT.
ANOTHER SNAPSHOT OF THE RISKS
OVER THE PAST YEAR OR SO, I
WON'T GO THROUGH ALL OF THESE
BUT PUT THEM UP TO HERE TO SAY
THEY ARE BROAD AND THERE'S QUITE
A NUMBER OF THEM.
THE ONES ON THE LEFT ARE WHAT
BUBBLED UP TO THE INSTITUTIONAL
LEVEL, COMPLIANCE EXECUTIVE
COMMITTEE OR RESEARCH RISK AND
COMPLIANCE.
ON THE RIGHT WE FOCUS ON THESE
IN THE RESEARCH INTEGRITY.
HUMAN SUBJECTS OUTSIDE
INTERESTS, FOREIGN INFLUENCE,
BROADER CONFLICTS OF INTEREST,
EXPORT CONTROLS ARE ALL ON
THERE.
I SHARE THIS ONLY TO SAY WHEN IT
COMES TO THINGS LIKE COMPLIANCE
AND IMPLEMENTATION OF NEW
POLICIES AS THEY EVOLVE, IT
BECOMES A MATTER OF
PRIORITYIZATION AND TRADEOFFS.
HERE IS A FEW EXAMPLES OF THE
TRADEOFFS WE'VE MADE, EVEN IN
RECENT YEARS.
THE FIRST IS EXAMPLE OF
INVESTING, AND THIS INVOLVES
MODERNIZING OUR RESEARCH I.T.
INFRASTRUCTURE.
NEW SOFTWARE PACKAGES ARE
PROBABLY NOT THE MOST EXCITING
THING TO TALK ABOUT BUT IT'S THE
FOUNDATIONAL INVESTMENT THAT CAN
HAVE BROADER IMPACT ACROSS THE
RESEARCH OFFICE AND MANAGE RISKS
IN MULTIPLE PROGRAMS.
IN THIS CASE WE'LL BE STANDING
UP A NEW SOFTWARE PACKAGE THAT
WILL LINK OUT SPONSORED
PROGRAMS, GRANTS AND CONTRACTS,
WITH RESEARCH COMPLIANCE
FUNCTION SO WE'LL HAVE BETTER
VISIBILITY INTO THE COMPLIANCE
OBLIGATIONS ASSOCIATED WITH
SPECIFIC AWARDS.
THIS WILL SERVE OUR CONFLICT OF
INTEREST PROGRAM, HUMAN SUBJECTS
PROGRAM, FORMING A FOUNDATION OF
YOU WHAT -- OF A BROADER
PLATFORM.
WE HAVE ANOTHER EXAMPLE OF
DEPRIORITIZING.
WE DID SCALE BACK OUR
CAPABILITIES TO DO SOME
INFECTIOUS DISEASE RESEARCH, ONE
OF THE THOSE INSTITUTIONS THAT
SHUTTERED OUR SELECT AGENT
PROGRAMMING, AND CONSIDERING
WHETHER TO DECOMMISSION OUR BSL3
FACILITY, EFFECTIVELY
DECOMMISSIONED FOR SOME YEARS,
UNDERGOING RENOVATION, PROVING
TO BE EXPENSIVE AND IT'S
PROBABLY NOT GOING TO BUY US
THAT MANY ADDITIONAL YEARS OF
SERVICE.
AS A RESULT OF GENERALLY
RELATIVELY LOW RESEARCH DEMAND
AND HIGH COMPLIANCE OBLIGATIONS,
DESIRE TO NOT CUT CORNERS ON
SAFETY WE SHUTTERED THOSE
PROGRAMS.
ANOTHER EXAMPLE COMES WITH DATA
AND INFORMATION SECURITY.
HERE WE'RE HAVE A MIXED BAG.
RECENTLY WE TERMINATED OUR
STATUS AS DoD-CLEARED
FACILITY, GIVING US POTENTIAL TO
ACCEPT AWARDS FROM DoD THAT
CONTAINED GENERATION OR STORAGE
OF CLASSIFIED INFORMATION.
WE TERMINATED BECAUSE OF A HIGH
COMPLIANCE BURDEN, REQUIRING
EXPERTISE, THAT WE NO LONGER HAD
WHEN WE LOST PREVIOUS EXPORT
OFFICER.
AND IN GENERAL THERE WAS LOW
DEMAND.
THERE'S NOT NO DEMAND, THIS DOES
COME AT A COST, FACULTY WANT TO
PARTICIPATE IN CLASSIFIED
RESEARCH AND WE'RE FIGURING OUT
WAYS THEY CAN PARTNER WITH
INDUSTRY AND OTHERS TO MAKE THAT
HAPPEN BUT WE CAN'T STORE THE
INFORMATION HERE AT OSU
ANYMORE.
WE'RE INVESTING AND HAVE CUI
CAPABILITIES, CHIEF INFORMATION
SECURITY OFFICER IS BUILDING UP
CAPABILITIES IN THE FRAMEWORK,
THE ONGOING RISK ASSESSMENT WE
MAKE AND HOW WE SET PRIORITIES
AND HOW WE TRY TO PLAN FOR THE
FUTURE.
THE QUESTION IS HOW DOES THIS
RELATE TO DURC?
IT'S ALL ABOUT INSTITUTIONAL
COMPLIANCE BUT THE KEY IS
POLICIES AND MANAGEMENT OF DUAL
USE RESEARCH RISKS WILL EXIST
WITHIN THIS INSTITUTIONAL RISK
ASSESSMENT AND COMPLIANCE
FRAMEWORK.
INSTITUTIONS ACROSS THE COUNTRY
WILL APPLY THEIR OWN RISK
ASSESSMENT FRAMEWORKS AS THE
DURC POLICIES EVOLVE.
AND WHEN THEY MAKE DECISIONS
ABOUT HOW TO IMPLEMENT IT AND
DEVOTE RESOURCES, THEY WILL
COMPARE IT WITH OTHER COMPLIANCE
OBLIGATIONS.
THEY WILL BRING TO BEAR THEIR
OWN PERCEPTIONS OF RISK, WE'LL
ASK QUESTIONS ABOUT WHAT
RESOURCES DO WE DEVOTE TO THIS,
AT THE PROJECT LEVEL IF WE
IMPLEMENT POLICY WE'LL HAVE OUR
OWN RISK TOLERANCE FOR
ACCEPTANCE OF DURC AND WHAT A
RISK MANAGEMENT STRATEGY OUGHT
TO LOOK LIKE.
WE'LL CONSIDER RESEARCH MISSIONS
AND PORTFOLIOS, ANY COMES DOWN
TO THE DEMANDS FOR RESEARCHERS.
IF WE HAVE A NUMBER OF
RESEARCHERS WHO WANT TO DO DURC
THAT'S SUBJECT TO POLICY IT'S
LIKELY WE'LL IMPLEMENT IT WELL.
WE MAY LOOK AT TRADEOFFS, IF WE
DON'T, AROUND SELECT AGENTS,
THIS ISN'T RESEARCH WE CAN
DEVOTE A LOT OF SUPPORT TO AT
OSU.
I THINK WE'LL ASK QUESTIONS
ABOUT HOW READILY DURC OVERSIGHT
CAN BE BUILT INTO EXISTING
PROGRAMS.
WE LEARNED A LOT THIS MORNING
ABOUT HOW THIS CAN BE DONE.
I'LL SHARE A COUPLE OTHER
THOUGHTS ON THAT.
SO AS WE THINK ABOUT THE FUTURE
OF DURC OVERSIGHT AND POLICIES,
I WOULD OFFER A FEW
CONSIDERATIONS.
ONE, I'D SUGGEST POLICIES DO NOT
NEED TO BE PERFECT.
THEY CAN'T BE BUT SHOULD BE
ADAPTABLE AND NIMBLE TO SOME
DEGREE.
I THINK WE'VE LEARNED AND I WAS
FORCED TO REMEMBER HOW DIFFICULT
THE DUAL USE DILEMMA IS AND HOW
COMPLEX IT'S PROVEN TO DEVELOP
POLICY AROUND.
THERE'S ALMOST A FUNDAMENTAL
DISAGREEMENT WHAT IS OF CONCERN
BUT THERE'S GENERAL AGREEMENT
THAT CONCERN IS RAPIDLY EVOLVING
AS SCIENCE EVOLVES, IT'S HARD TO
WRITE RULES AROUND THAT.
WE KNOW SOME RISKS ARE EASIER TO
MANAGE THAN OTHERS.
WE HEARD ABOUT BIOSAFETY AND
PHYSICAL SECURITY, THINGS LIKE
THAT.
BUT MANAGING RISKS ASSOCIATED
WITH INFORMATION HAS PROVEN
REALLY CHALLENGING.
SHORT OF REDACTION, WHICH ISN'T
SIMPLE, I'M NOT SURE WHAT
EXACTLY A GREAT STRATEGY IS TO
MANAGE INFORMATION.
WE TALKED THIS MORNING ABOUT THE
SCOPE, I WON'T GO INTO DETAIL,
OTHER THAN TO SAY THAT NO MATTER
THE SCOPE, WHETHER LIST OR RISK
BASED, EACH WILL HAVE THEIR OWN
STRENGTHS, THEIR OWN
LIMITATIONS, NOUN WILL BE --
BUT NONE WILL BE PERFECT.
I SUGGEST FOCUS ON HIGHEST, WITH
GENERAL AGREEMENT, AND POLICY
SHOULD INCLUDE SOME MECHANISM
FOR PERIODICALLY UPDATING THE
POLICY TO EXPAND OR LOOSEN
OVERSIGHT.
I THINK WE'RE IN A GOOD POSITION
NOW, DISCUSSIONS HAVE GONE ON
FOR ALMOST 20 YEARS NOW, AND THE
POLL IS ABOUT TEN YEARS OLD.
WE CAN LEARN FROM EXPERIENCE.
I ASSUME WE ARE.
I THINK THAT JUST HAVING THESE
STAKEHOLDER CONVERSATIONS IS
BENEFICIAL AND IMPORTANT.
HERE'S SOME QUESTIONS WE MIGHT
CONSIDER, ANYTIME WE WANT TO
REVISE THE POLICY.
HOW MUCH DURC HAVE WE IDENTIFIED
ALREADY?
UNDER THE TWO EXISTING POLICIES
WE KNOW WE'VE IDENTIFIED SOME.
WE CAN ASK QUESTIONS HOW MUCH
WE'VE IDENTIFIED AND
SPECIFICALLY HOW CONCERNING
THOSE EXPERIMENTS ACTUALLY ARE.
IS THERE BROAD AGREEMENT THAT
WHAT WE'VE IDENTIFIED
CONSTITUTES DURC AND CONCERNING
ENOUGH THEY REQUIRE ADDITIONAL
OVERSIGHT?
MAYBE WE'RE IDENTIFYING THINGS
THAT AREN'T SO WORRISOME.
WE CAN TAKE A LOOK AT RISK
MANAGEMENT PLANS AND SEE IF
WE'RE IDENTIFYING GOOD
STRATEGIES HOW TO MANAGE
ESPECIALLY INFORMATIONAL RISKS,
BUT ANY OTHER RISKS.
WE CAN SEE IF STUDIES WERE
IDENTIFIED AT DURC BUT DIDN'T
NEED TO BE COVERED BY THE
POLICY.
HOW WERE THEY HANDLED, IS THERE
AGREEMENT THEY SHOULD HAVE BEEN
COVERED, IF FINE THEY FELL
OUTSIDE THE POLICY?
HOW WERE THEY MANAGED?
WERE THERE CONSEQUENCES TO
MANAGING AT DURC OR NOT AS DURC?
IN ADDITION WE SHOULD ASK
QUESTIONS ABOUT RESOURCING.
HOW MANY RESOURCES WERE DEVOTED
BY FEDERAL FUNDING AGENCIES AND
INSTITUTIONS TO IDENTIFY AND
MANAGE DURC?
WAS THAT COMMENSURATE WITH
RISKS?
WE SHOULD THINK ABOUT SOME
OPPORTUNITY COSTS, WHAT POLICY
OR COMPLIANCE OBLIGATION OR
RESEARCH INTEGRITY EFFORT DID WE
DEPRIORITIZE TO FOCUS ON DURC?
I THINK WE CAN LOOK TO THE
ENHANCEED PATHOGENS WITH
PANDEMIC POTENTIAL FRAMEWORK.
I'M BIASED, I MADE A ROLE IN THE
DELIBERATIONS, HELPING TO
DEVELOP THAT POLICY BUT IT'S A
SOLID STARTING POINT FOR A
NUMBER OF REASONS.
FIRST, IT'S AN INSTANCE WITH
GENERAL AGREEMENT THAT
SOMETHING, THESE TYPES OF
STUFFEDDIES CONSTITUTE DEREK.
A -- THAT CONSTITUTE DURC.
IT STARTS WITH THE FEDERAL LEVEL
IDENTIFICATION OF DURC AT THE
TIME OF FUNDING.
THIS IS IMPORTANT.
AND THEN IT LEVERAGES EXPERTISE
WE HAVE AMONG FEDERAL AGENCIES
AND ACCESS TO SCIENTIFIC
EXPERTISE, TO MAKE GOOD FUNDING
DECISIONS ABOUT WHAT WE WANT TO
PURSUE AND FUND MOVING FORWARD.
IT THEN MOVES TO A PARTNERSHIP
APPROACH AND ONGOING OVERSIGHT
WITH RESEARCH INSTITUTIONS.
THIS ISN'T PERFECT BUT I THINK
THE GENERAL FRAMEWORK IS A GOOD
PLACE TO PART.
I'M HAPPY TO HEAR THAT FRAMEWORK
IS BEING REVISITED.
I WOULD JUST REMIND US THAT DURC
OVERSIGHT IS RELATED TO COME OF
COMPLIANCE PROGRAMS AND
OBLIGATIONS AND SHOULD BE
CONSIDERED WITHIN THAT CONTEXT
OF PRIORITIZED.
IT'S NOT EXACTLY TRUE THAT
ANYTIME THERE'S A POLICY CHANGE
WE'LL SEE DO WE FOCUS ON DURC OR
ON CONFLICT OF INTEREST OR FOCUS
ON REPORTING SEXUAL MISCONDUCT?
TO SOME DEGREE THERE'S SOME
TRUTH.
WE NEED TO PRIORITIZE WHERE WE
CAN DEVOTE RESOURCES.
THE MORE WE CAN BUILD DURC INTO
EXISTING FRAMEWORKS LIKE
BIOSAFETY WHICH WE'VE HEARD
ABOUT, THE BETTER.
I THINK EXPORT CONTROLS MAY BE
AN IMPERFECT MODEL BUT IT'S ONE
TO THINK ABOUT.
UNDER THIS PARADIGM WE MIGHT
THINK ABOUT DURC BEING A
CONTROLLED EXPORT.
HERE WE HAVE INSTITUTIONAL
EXPORT COMPLIANCE PROGRAMS
HANDLING DURC, IN PRACTICE YOUR
EXPERT CONTROL OFFICER COULD
EDUCATE WHAT DURC IS, POLICY
REQUIREMENTS, AND INVESTIGATORS
WOULD BE RESPONSIBLE FOR
IDENTIFYING POTENTIAL DURC,
SEEKING ADVICE AND PURSUING A
LICENSE OR DEVELOP A TECHNOLOGY
CONTROL PLAN, WHATEVER MIGHT BE
NEEDED.
THIS ISN'T PERFECT BUT LEVERAGES
COMPLIANCE PARADIGMS THAT ARE
ALREADY INVOLVED IN CONTROLLING
THE EXCHANGE OF INFORMATION AND
TECHNOLOGY.
WORKS IN A PARADIGM THAT'S
NATIONAL SECURITY FOCUSED,
MARRYING WHAT WE THINK ABOUT
WITH DURC, A HEAVY LIFT THAT
WOULD REQUIRE THE GOVERNMENT TO
BUILD DURC, REQUIRE CLEAR AND
SPECIFIC DEFINITIONS AND
DELINEATIONS, LICENSE
REQUIREMENTS,ING AND THAT WOULD
ADD A LEVEL OF SPECIFICITY A
LISTED BASED APPROACH RATHER
THAN AWAY FROM IT, PLAUSIBLE BUT
MAYBE NOT PREFERRED.
I'LL END WITH A LAST EXAMPLE OF
RESEARCH MISCONDUCT AND WHAT I
THINK MUCH AS VALUE OF OUTREACH
AND EDUCATION.
THERE COULD BE PARALLELS AND
LESSONS FOR DURC.
AS WE ALL KNOW RESEARCH
INSTITUTIONS ARE REQUIRED TO
RESPOND TO ALLEGATIONS OF
RESEARCH MISCONDUCT, NARROWLY
DEFINED AS FABRICATION,
FALSIFICATION, PLAGIARISM,
SETTING DISCREET TIMELINES,
RECORDS, DIGITAL AND PHYSICAL.
FORM A COMMITTEE, ENTER VIEWERS
WITH WITNESSES AND RESPONDENTS,
THERE'S FINDINGS AND
RECOMMENDATIONS.
IT'S A RESOUR INTENSES PROCESS,
AND HERE AT OSU, PRIORITIZED
OVER ALL ACTIVITIES.
OTHER ACTIVITIES ARE NOT
UNIMPORTANT.
IT INVOLVES DEVELOPING POLICIES,
PROCESSES, SHE HAS RESEARCH
INITIATIVES TO ROLL OUT.
SHE HAS A LOT OF OUTREACH AND
EDUCATION SHE WOULD DO INCLUDING
AUTHORSHIP GUIDANCE, ONE OF THE
MOST COMMON THINGS, AND DEVELOP
GUIDANCE FOR FACULTY ON HOW THEY
ENTER A LAB, LEAVE A LAB WHICH
MIGHT INCLUDE DISPOSES EVER
CHEMICALS.
SHE TALKED ABOUT AVOIDING
DETRIMENTAL PRACTICES, TRAINING,
ALL THE CONSULTATIONS NEED TO BE
PUT ON PAUSE DURING MISCONDUCT
INVESTIGATION.
WHEN WE DO MORE OUTREACH WE GET
MORE CONSULTATIONS.
WE GIVE MORE ADVICE, MORE
GUIDANCE AND OFFER MORE ADVICE
AND GUIDANCE ABOUT RESPONSIBLE
RESEARCH.
A LESS OWN IS NOT THAT WE SHOULD
STOP DOING RESEARCH MISCONDUCT
INVESTIGATIONS.
IT'S JUST TO SAY THE PRO-ACTIVE
OUTREACH THAT WE CAN DO ALSO HAS
A SIGNIFICANT POSITIVE IMPACT ON
RESEARCH INTEGRITY, IN MY
OPINION I THINK IT MIGHT BE MORE
TO BUILD THAT CULTURE OF
RESPONSIBILITY AMONG FACULTY AND
OPPORTUNITIES THAN FOCUSING
NARROWLY ON INVESTIGATION OF
PLAGIARISM.
ONLY ONE CAN BE DONE AT A TIME.
ONE PATH THAT WE MIGHT CONSIDER
FOR DURC OVERSIGHT, WHAT I CALL
OUTREACH HEAVY AND POLICY LIGHT.
WE PRIORITIZED THE WAY DAVID
SUGGESTED WITHIN INSTITUTIONS
AND PROFESSIONAL SOCIETIES,
FOCUSED ON BUILDING CULTURE OF
RESPONSIBILITY.
OUTREACH MIGHT INCLUDE POLICY
REQUIREMENTS, SHOULD GROW BEYOND
THAT AND BE MORE FORWARD LOOKING
AND INCLUDE OPEN-ENDED
CONVERSATIONS ABOUT DUAL USE
RESEARCH AND ETHICAL ISSUES
ASSOCIATED WITH EMERGING
TECHNOLOGIES.
I WAS REMINDED THIS MORNING OF
OLD WORK ON CODES OF CONDUCT AND
DREW'S CONDUCT, IMWONDERED IF
DREW AND I WERE TO GET TOGETHER
WITH DEFACULTY FROM OUR
INSTITUTIONS AND DEVELOP BIOCODE
OR CODE OF CONDUCT THAT MIGHT GO
FARTHER IN PROMOTING -- BUILDING
A CULTURE OF RESPONSIBILITY,
PROMOTING RESEARCH INTEGRITY
THAN ANY POLICY COULD DO.
UNDER THIS APPROACH WE WOULD WE
RELY ON CONTROLS, NOT PERFECT
BUT MANAGING RISK.
WE WOULD FOCUS PRESCRIPTIVE ON
HIGHEST PRIORITY AREAS, PPE OR
SOME OTHER SET, TO INFORM
FUNDING DECISIONS AND HAVE A
PARTNERSHIP WITH INSTITUTIONS AS
WE MOVE FORWARD.
I WANT TO THANK EVERYONE AND
ACKNOWLEDGE THE OPINIONS WERE
MINE BUT I APPRECIATE THE FOLKS
WHO HAVE BEEN EXCELLENT MARTERS
IN WITH ME ON THIS TO HELP SHAPE
THE WAY I THINK ABOUT IT.
>> THANK YOU SO MUCH, CHRIS.
I RESEARCH MY QUESTIONS FOR THE
GROUP.
THERE'S A LOT.
THANK YOU VERY MUCH.
AND THEN I'D LOVE TO TURN IT
OVER TO DR. KUZMA.
THE FLOOR IS YOURS.
>> GREAT.
THANK YOU FOR INVITING ME.
I'M GOING TO TITLE MY TALK
"POINTS TO CONSIDER" BECAUSE
THIS AREA IS SOMETHING THAT I
USED TO BE A BIT MORE INVOLVED
IN BUT HAVE RECENTLY TURNED MORE
TO BIOSAFETY AND GENETIC
ENGINEERING THAN BIOSECURITY.
AND IN PARTICULAR, BIOSAFETY AND
BY AGRICULTURE, IN OF THE
ECOLOGICAL SETTINGS.
I WORKED ON RISK ASSESSMENT IN
FOOD BORNE PART GENERALS AND WAS
A STUDY DIRECTOR BACK IN 1998
THROUGH 2002 FOR BIOTERRORISM
AND BIOSECURITY AT THE NATIONAL
ACADEMIES OF SCIENCES INVOLVED
IN BEING DIRECTOR OF A REPORT ON
COUNTERING AGRICULTURE
BIOTERRORISM AND SAT IN ON SOME
THINK COMMITTEE MEETINGS WHERE
THEY WERE DEVELOPING THE
EXPERIMENTS OF CONCERN.
BUT RECENTLY MORE ON BIOSAFETY
GENERALLY IN AGRICULTURE AND
ECOLOGICAL SETTINGS, I WANT TO
PREFACE MY REMARKS WITH THAT.
I DO TEACH POLICY ANALYSIS.
FIRST SET OF COMMENTS IS ON
POLICY ANALYSIS.
IN POLICY ANALYSIS THERE ARE
MORE INFORMAL OR MORE FORMAL
WAYS TO DO IT.
MY FIRST POINT WOULD BE I'D LIKE
TO SEE A MORE FORMAL POLICY
ANALYSIS OF THE DURC POLICIES
FROM 2012 TO PRESENT, SOME
MENTIONED IT BEFORE BUT WE COME
UP WITH MULTIPLE CRITERIA.
THIS IS PLAN DATED.
THERE WAS AN INITIAL AUDIT-TYPE
ANALYSIS OR SCRIPTIVE ANALYSIS
THAT WAS CODIFIED IN POLICIES IN
2012.
I'M WONDERING WHAT THE RESULTS
HAVE BEEN OF THOSE AND WHETHER
OR NOT THERE'S AVAILABLE DATA ON
THAT.
AND SO IT WOULD BE INTERESTING
TO SEE THE DESCRIPTIVE.
SEEING CALLS IN THE 2014 AND 15
POLICY FOR PERIODIC EVALUATION
OF THE DEREK.
SO OF COURSE IN EVALUATING
POLICIES YOU HAVE TO STRIKE A
BALANCE BETWEEN BIOSECURITY AND
OPENNESS.
I'D LIKE TO SEE MORE PUBLIC
TRANSPARENCY.
IN FACT WE OFTEN TALK ABOUT
DERIVING YOUR EVALUATION
CRITERIA IN THE PRESENCE OF
PUBLIC AND STAKEHOLDER
ENGAGEMENT.
I DON'T SEE HOW THAT WOULD RISK
BIOSECURITY IF YOU HAD A VERY
INFORMED PUBLIC AND STAKEHOLDER
MORE FORMAL APPROACH TO SETTING
A SET OF EVALUATION CRITERIA FOR
DURC POLICIES.
THIS MEETING IS PART OF THAT
EVALUATION, NSABB IS DOING THAT
BUT I'D LIKE TO SEE A MORE
TRANSPARENT AROUND PUBLIC
ENGAGED PROCESS TO MORE FORMAL
POLICY ANALYSIS.
IN LOOKING AT CRITERIA, TIMES OF
COMPLIANCE, ESTIMATION OF RISK,
COST, TRANSPARENCY, MULTIPLE
ETHICAL CRITERIA AS WELL, THAT
WAS GOING TO BE MY FIRST POINT.
I'LL MOVE TO THE SECOND, THAT
COMMENTS FROM A RISK SCIENCE
PERSPECTIVE.
ONE OF THE BENEFITS OF GOING
LAST, PEOPLE SAID EVERYTHING
ALREADY.
THIS IS A LITTLE REDUNDANT.
SELECT AGENTS AND SEVEN
EXPERIMENTS OF CONCERN, I THINK
MORE FOCUS IN LIGHT OF THE PACE
OF MODERN BIOTECHNOLOGY AND
THINGS WE'RE ABLE TO DO NOW ON
THE SEVEN EXPERIMENTS OF CONCERN
WOULD BE PERHAPS A BETTER
APPROACH THAN THE SELECT AGENTS
AND SEVEN EXPERIMENTS OF
CONCERN.
MAYBE IT'S AS SIMPLE OF CHANGING
AND TO OR.
I'M DONE A LOT IN MY CENTER AT
N.C. STATE, A LOT OF WORK ON
GENE DRIVES, IN PARTICULAR FOR
POPULATION EXPRESSION OR TO
BETTER COMBAT OR IMMUNIZE.
THESE HAVE POTENTIAL FOR MISCUES
ON SECURITY, BIOSAFETY, OTHERS
MENTIONED SYNTHETIC BIOLOGY,
WHAT MIGHT NOT HAVE BEEN
MENTIONED BEFORE IS THESE WHAT I
CALL IN SITU GENE EDITING
AGENTS, MIGHT NOT BE A LIVING
THING YOU MIGHT NEED TO WORRY
ABOUT BUT A DELIVERY PARTICLE
FOR GENE EDITING MACHINERY OR
INSECTS DELIVERING GENE EDITING
OR PHAGES INTO HUMAN AND NATURAL
ECOSYSTEMS TO DRIVE GENES INTO
POPULATION AND DRIVE THEM INTO
EXTINCTION.
ANOTHER SET OF HAZARDS, WHITE
NOSE SYNDROME IN BATS IS THE
WORST WILDLIFE DISEASE IN MODERN
TIMES.
AND THEN OTHERS HAVE MENTIONED
ZOONOTIC AND ANIMAL HAZARDS NOT
ON THE LIST, THINGS I USED TO
WORKO E. COLI, SOYBEAN RUST,
SALMONELLA, AND PRIVATE SECTOR
AND NON-FEDERALLY FUNDED
INSTITUTIONS, THOSE WERE SOME
THINGS I THOUGHT TAKING A LOOK
AT THE POLL POLICIES ON RISK
COVERAGE SIDE.
YOU HAVE A BALANCE BETWEEN
OVERAND UNDERCOVERAGE, AND I
THINK I COVERED THIS, I THINK
THIS GROUP KNOWS WHAT A GENE
DRIVE IS, BUT IT'S BEING APPLIED
TO ALL KINDS OF APPLICATIONS.
IT COULD BE A MOUSE, A MOSQUITO
OR PLANT.
WHAT HASN'T BEEN TALKED ABOUT AS
MUCH, THE THIRD PERSPECTIVE.
I HAVEN'T BEEN IN THE LAB FOR 25
YEARS, I'VE BEEN A SOCIAL
SCIENTIST AND RISK GOVERNANCE
SCHOLAR IN THE INTERIM.
I ASK IN THE BOTH SAFETY REALM
THAT I'LL POSE TO THIS GROUP
ABOUT HOW ARE RISKS ANALYZED BY
INSTITUTIONS.
IN PARTICULAR MISUSE OR
UNINTENTIONAL LEASE INVOLVES
SOCIAL AND CULT RAIL FACTORS BUT
I'VE SEEN MORE WEIGHTED.
THAT CAN POSE CONFLICTS OF
INTEREST, POSE SUBCONSCIOUS BY
AS.
WE ALL HAVE BIASES.
HOW DO WE REMEDY FOR THIS?
I THINK BROADENING THESE GROUPS
CAN INCLUDE SOCIAL SCIENTISTS,
BEHAVIORAL, SOCIOLOGIST EARNINGS
ANTHROPOLOGY.
IT'S NOT JUST ABOUT SCIENCE.
I HAVE SLIDES I CAN'T SHOW.
CHOICE OF THE ENDPOINTS WE CARE
ABOUT, PERCEPTION OF RISK,
INTERPRETATION OF UNCERTAINTY,
EVEN SCIENTISTS HAVE COGNITIVE
WAYS THAT THEY BRING THEIR
VALUES TO PLAY IN INTERPRETING
RISK.
THAT'S THE MORE SOCIAL SCIENCE.
RISK ANALYSIS IN ME SAYS THERE'S
A LOT OF METHODS FOR ANALYZING
RISK.
CAN WE IN SOME CASES REPLACE A
CHECKLIST APPROACH TO MORE --
WHEN IT'S WARRANTED, NOT PERHAPS
FOR EVERY CASE BUT WHEN
WARRANTED FOR MORE INTENSIVE
METHODS.
HOW TO MITIGATE PUBLIC MISTRUST
AND IMPROVE LEGITIMACY, BY
OPENING UP THE PROCESS WHILE
PROTECTING SENSITIVE AND
CLASSIFIED INFORMATION OF COURSE
BUT OPENING PROCESSES LIKE
INVITING A BROADER BREADTH OF
STAKEHOLDERS AND PUBLIC
REPRESENTATIVES FROM
MARGINALIZED, DIVERSE,
UNDERREPRESENTED GROUPS, A WIDE
RANGE OF EXPERTS MIGHT HELP.
IT'S NOT ENOUGH BUT IT'S THE
FIRST STEP I THINK TO
ESTABLISHING TRUST.
ESPECIALLY IN THE WAKE OF THE
SARS-COV-2 AND ORIGIN THEORIES,
MANY OF WHICH HAVE LEGITIMACY.
DoD HAS BEEN INVOLVED IN
DEVELOPING SOME OF THESE
TECHNOLOGIES, INSECT ALLIES
PROJECT FOR DELIVERY OF GENES
THROUGH INSECTS, OR THROUGH
MAKING GENE DRIVES MORE SAFE,
SOMETIMES THAT CAN CAUSE PUBLIC
CONCERN AS WELL.
HOW CAN WE MITIGATE TECHNO
OPTIMISM WHICH MAY CAUSE US TO
OVERLOOK SITUATIONS IN WHICH WE
SHOULD BE MORE PRE-CAUTIOUS, WHO
MAKES THESE DECISIONS, CAN WE
OPEN THE PROCESS FOR MORE
INDEPENDENT POLICY VENUES AND
ENGAGEMENT OF
NON-BIOTECHNOLOGISTS IN DECISION
MAKING TO MITIGATE THESE
CONFLICT OF INTEREST AND BY AS?
AND QUICKLY JUST IN CLOSING ONE
MODEL FOR THAT THAT I'VE STUDIED
IS RESPONSIBLE RESEARCH AND
INNOVATION, COULD THIS BE
APPLIED TO DURC?
THIS IS THE BOTTOM-UP APPROACH
OTHERS MENTIONED IN WHICH
RESEARCH TEAMS WOULD ENGAGE IN
RESPONSIBLE AND INNOVATION
PROCESSES, TO OPEN UP THE
PROCESS TO SUSTAINABILITY OF THE
INNOVATION.
TO LEGITIMIZE THE RESEARCH AND
INNOVATION THROUGH OPEN
DISCOURSE.
SO THERE ARE FOUR PRINCIPLES OF
RESPONSIBLE IS INNOVATION.
WE HAVE DONE SOME WORK ON
LOOKING AT BIOTECHNOLOGY
STAKEHOLDER ATTITUDES TOWARDS
THESE, AND WE DO FIND THAT
SECTOR AFFILIATION DOES
INFLUENCE ATTITUDES, INDUSTRY
AFFILIATED SECTORS HAVE MORE
NEGATIVE VIEWS.
THAT A LOT OF THESE ATTITUDES,
THEY ARE EMBEDDED IN DEEP CORE
BELIEFS, OF PEOPLE.
WE HAVE SOME CHALLENGES TO
OVERCOME IN FOSTERING A CULTURE
OF RESPONSIBILITY.
BUT THERE'S SOME HOPE TOO
BECAUSE IN THEORY MOST PEOPLE
AGREE ON THE GENERAL PRINCIPLES.
IT'S WHEN YOU PUT THEM INTO
PRACTICE THAT YOU FIND MORE
DISAGREEMENT.
WE'VE TYPED THE BARRIERS TO
RESPONSIBLE INNOVATION.
AGAIN, THESE MACRO LEVEL FORCES
OF COMPETITION IN THE
BIOTECHNOLOGY INDUSTRY, HAVING
TO MEET TIME PRESSURES AND
DEADLINES, NOT HAVING
ORGANIZATIONAL CAPACITIES OR
INCENTIVE STRUCTURES IN ORDER
TO -- THOSE ARE MESO-LEVEL.
THESE ARE IMPORTANT BARRIERS
THAT ARE FACED.
SOME THINGS I RECOMMENDED IN AN
ARTICLE UNDER REVIEW, FOR
FEDERAL AGENCIES I THINK COULD
PROVIDE GREATER RESOURCES INTO
THE PROPOSALS AND OVERCOMPENSATE
THEM.
TO PROVIDE BLOCK GRANTS FOR
INSTITUTIONS THAT HAVE WAYS TO
EMBED BOTTOM-UP METHODS FOR
RESPONSIBILITY, CERTIFY
ORGANIZATIONS AND OF COURSE AS
OTHERS HAVE MENTIONED DEVELOP
TRAINING PROGRAMS.
SUMMARY OF THE POINTS AGAIN ON
THIS SLIDE.
AND I THINK I'LL JUST REFRAIN
FROM READING ALL OF THEM BUT WE
HAVE BETTER POLICY, MORE FORMAL
POLICY ANALYSIS, DEVELOPING CITE
FOR EVALUATION, CONSIDERING
AGENTS OUTSIDE, ESPECIALLY GENE
DRIVES AND NON-LIVING AGENTS.
OPENING UP THE DURC PROCESS TO
INCORPORATE A RANGE OF VALUES
AND THEN AGAIN CONSIDERING OUR
PARADIGMS, HOW TO INCENTIVIZE
WITH FEDERAL FUNDING.
>> THANK YOU.
>> THANK YOU FOR THE COMMENTS.
EXTREMELY THOUGHTFUL.
ASKING THE PANELISTS TO TURN ON
CAMERAS.
WE HAVE 15 MINUTES FOR A
CUSHION.
I WELCOME OTHERS ON THE ZOOM
MEETING TO RAISE THEIR HAND TO
ASK A QUESTION.
I'LL YIELD TO GET THOSE
LISTENING ENGAGE.
>> THANK YOU.
THAT SESSION WAS REALLY GOOD,
INFORMATIVE.
I JUST WANT TO MAKE AN UBER
OBSERVATION WHICH IS PROBABLY
GOING TO ECHO A MILLION THINGS
THAT HAVE BEEN SAID.
I WANT TO POINT OUT THAT THIS IS
A STAKEHOLDERS MEETING BUT
EVERYONE WAS FROM ACADEMIA AND I
THINK THAT SAYS A LOT, WHAT WE
NEED TO BE THINKING ABOUT,
BECAUSE I DON'T KNOW ABOUT THE
REST OF YOU BUT MOST OF OUR
TRAINEES ARE LEAVING ACADEMIA
AND OPPORTUNITIES ARE GOING TO
BE ENORMOUS FROM NEW FUNDING
MODELS OCCURRING ALREADY.
I THINK THIS PROBLEM, WE'VE
HEARD A LOT ABOUT BOTTOM-UP, ET
CETERA, BUT I THINK WE NEED TO
START THINKING ABOUT THIS IN
SIGNIFICANTLY SORT OF A NOT AN
NIH-CENTRIC WAY, IF THAT'S
POSSIBLE.
>> I'LL OPEN UP TO THE PANEL.
I'D LOVE TO HEAR MORE FROM THE
PANELISTS.
>> I MIGHT JUMP OFF.
THAT'S A GOOD POINT AND SPEAKS
TO -- TWO WAYS TO GET AT THAT.
ONE IS BROADER REGULATIONS THAT
TOUCH ON INDUSTRY, OR APPROACH
THAT I MIGHT FAVOR IS JUST THE
IMPORTANCE OF RAISING AND
TRAINING YOUNG SCIENTISTS TO
HAVE INTEGRITY AND RESPONSIBLE
CONDUCT.
SO THE MORE YOU CAN INSTILL THAT
TRAINING AND IMPORTANCE AS THEY
ARE TRAINED THEY BRING THAT WITH
THEM TO INDUSTRY OR WHENEVER
THEY CAN.
>> ONE THING IS LOOK AT
PARALLELS, WHAT HAPPENED IN
ENGINEERING WRIT LARGE IN THE
LAST CENTURY, PEOPLE DON'T DO
POSTDOCS, IN ENGINEERING, THEY
GO STRAIGHT TO JOBS.
DO THEY BEHAVE IN AN ETHICAL
WAY?
WE CAN DEBATE THAT.
I THINK THERE'S PRIVATE INDUSTRY
AND THERE'S GOVERNMENT BUT THEN
THERE'S GOING TO BE THIS HUGE
MIDDLE GROUND OF LIKE THE SAUDIS
ARE GOING TO FUND MORE AGING
RESEARCH THAN THE NIH DOES PER
YEAR.
AND THESE NEW ENTITIES THAT ARE
BEING FUNDED BY, YOU KNOW, THE
UBER WEALTHY, THAT'S GOING TO
START TAKING UP A LARGE AMOUNT
OF OUR NATIONAL FUNDING, BARRING
WHAT HAPPENS WITH THE ECONOMY.
THAT'S A UNIQUE SESSION WHERE A
LOT OF TRAINEES ARE GOING TO GO.
>> DAVID, YOU CAME OFF MUTE.
>> YEAH, TWO THINGS TO SAY.
THANK YOU, LYRIC.
THE FIRST IS A LITTLE BIT
SELFISH.
WE HAVE WHERE THE GREAT
RESIGNATION OVER A DOZEN OPEN
POSITIONS.
IF YOU WANT A JOB, COME SEE US.
THAT TELLS YOU THERE'S A
DRAMATIC NEED TO GET PEOPLE UM
TO SPEED IN TERMS OF
UNDERSTANDING THE BUT ALSO ON
THE OTHER SIDE, RESEARCH SIDE,
MAKING SURE PEOPLE UNDERSTAND,
UNDERSTAND TO CHRIS'S POINT HOW
TO MAKE THEM BE RESPONSIBLE.
I DISCUSSED MAYBE THIS SHOULD BE
MORE LOCALIZED, DONE AT THE
INSTITUTIONS SO IT'S NOT AS MUCH
NIH FOCUS, IT'S WHAT YOU
MENTIONED, PAMELA.
THE
THE FACT YOU USED TO DO MORE
OUTREACH, GOING TO INSTITUTIONS,
AND I'M NOT JUST SAYING IT'S
YOU, IT'S A BIG -- WE'VE GOT
LOTS OF AGENCIES, WE NEED MORE
EDUCATION THAN TRAINING.
IT NEEDS TO HAPPEN.
WE'RE NOT FOG TO CREATE A
POLICY, HERE'S THE POLICY, THIS
IS HOW WE'RE GOING TO PLYMOUTH
OF IMPROMOTE IT.
>> AND ONCE OF THE THINGS --
THANK YOU.
WE APPRECIATE POSITIVE FEEDBACK.
I WANT TO ACKNOWLEDGE U.S.
GOVERNMENT IS STRONGLY
INTERESTED IN THIS THINKING
ABOUT THIS FROM A NON-NIH
PERSPECTIVE AND WILL GET INTO IN
A MAR.
THAT COMMENT IS HEARD.
JERRY, WOULD YOU LIKE TO
COMMENT?
>> SURE.
DAVID, FOLLOWING UP A LITTLE
BIT, THE OTHER CHRISTOPHER,
JENNIFER IS WELL, HOW THIS MIGHT
BE IN THE FUTURE.
WHAT DO YOU THINK -- RICHARD MAY
HAVE MENTIONED THIS IN PUBLIC
COMMENTS, ABOUT AN INDEPENDENT
BIOLEWIS MANAGEMENT AUTHORITY.
ANY COMMENTS ON THAT?
>> I'VE BEEN THINKING ABOUT
THIS, MORE IN THE WAY OF
REGULATION.
YOU HAVE THE SAME PROBLEMS AS
YOU DO SIMILAR PROBLEMS, WITH
MULTIPLE AGENCIES, WITH
OVERLAPPING AUTHORITIES,
SOMETIMES GAPS, SOMETIMES
REDUNDANCIES.
OSTP HAS TAKEN A LEAD IN THE
PAST SOMETIMES OVER TIME WITH
THE COORDINATED FRAMEWORK FOR
REGULATION OF BIOTECHNOLOGY.
I LIKE THE IDEA OF SOMETHING
EVEN MORE INDEPENDENT THAN THAT
BUT I THINK THAT MIGHT BE A
START, IN OSPT HAVING SOME
INTELLECTUAL PROPERTIEDENT UNIT,
LIKE YOU SUGGEST.
I WOULD LOVE TO SEE THE SAME
THINGS REGULATING PRODUCTS FOR
BIOSAFETY.
THAT'S MY PERSPECTIVE.
>> YEAH, I'LL ADD.
GOVERNMENT-- REGULATORY
OVERSIGHT CAN SOMETIMES CAUSE
PROBLEMS.
WHEN YOU CENTRALIZE, WHETHER
GEORGE BUSH CENTRALIZEs TSA,
IF WE'RE GOING TO DO IT, DOUGH
IT RIGHT TO STREAMLINE, TO MAKE
IT EASIER TO MANAGE AND IDEALLY
IF WE'RE GOING TO HAVE A SYSTEM
THINK ABOUT ALL THE OUTCOMES,
WHAT PROBLEMS ARE WE SOLVING AND
CREATING.
YOU HAVE TO THINK THROUGH THE
WHOLE PROCESS.
I DON'T HAVE A STRONG ANSWER
OTHER THAN IF YOU'RE GOING TO DO
IT, DO IT RIGHT.
>> I WOULD ADD THIS IDEA OF A
CENTRAL COMMISSION OR SOMETHING
ALMOST PARABLES THE HHS GAIN OF
FUNCTION FRAMEWORK WHERE YOU
HAVE A GROUP THAT BRINGS HIGH
LEVEL EXPERTISE.
I LIKE THAT AS A MODEL, I DON'T
KNOW WHETHER IT'S EXPER TUESDAY.
IT'S A REASONABLE STARTING POINT
BUT I WOULD CAUTION UNTIL WE
KNOW SHOULD FOCUS ON A NUMBER OF
EXPERIMENTS AND SHOULD CONSIDER
THE OTHERS, WHAT ARE THE RISKS
NOT NIH THAT NEED TO GET MANAGED
BETTER.
>> ANOTHER QUESTION, BUT I'LL
YIELD TO OTHERS WITH QUESTIONS.
>> JILL TAYLOR?
>> THIS WAS AN INTERESTING
SESSION TO ME BECAUSE I THINK
ABOUT RISK INCOME A DIFFERENT
WAY BECAUSE I COME FROM PUBLIC
HEALTH.
AND I WOULD ASK YOU WHEN YOU'RE
DOING THIS ANALYSIS, NSABB IS
DOING THIS, KEEN THE DOWNSTREAM
KENSES AND U.S. ABILITY TO
MANAGE A POTENTIAL ESCAPE,
ACCIDENT, WHATEVER.
AS PART OF THE DISCUSSION.
I HAVEN'T HEARD A LOT ABOUT THAT
DISCUSSION TODAY.
THAT'S NOT A CRITICISM, JUST A
COMMENT, PLEASE KEEP THAT AS
PARTS OF WHAT YOU'RE TALKING
ABOUT, WHAT OTHERS ARE TALKING
ABOUT.
THANK YOU.
>> A QUICK COMMENT.
I THINK THAT'S A GREAT COMMENT.
IT RELATES TO ENDPOINTS OF
CONCERN, IN RISK ASSESSMENT
WORLD THAT WE CALL THEM, WHERE
THE BALANCE BETWEEN OPENNESS AND
SECURITY ISN'T AS DIFFICULT
BECAUSE YOU COULD HAVE PEOPLE
HIGHLIGHT DIFFERENT TYPES OF
ENDPOINTS OF CONCERN OR RISK AND
MAKE SURE POLICIES AROUND THEM.
A GREAT PLACE FOR STAKEHOLDER
ENGAINMENT.
>> THINKING ABOUT THE FUTURE OF
THE POLICY, AREAS OF IMPROVEMENT
OR THOUGHTS, INTERESTING TO HEAR
ABOUT HOW YOUR UNIVERSITY THINKS
ABOUT SOME TRADEOFFS AND THAT
MAKES SENSE TO KEEP HIGH
STANDARDS AND PRIORITIZE.
THIS MORNING WE HEARD ABOUT THE
DESIRE OR SOME VALUE IN
CENTRALIZING RESOURCES FOR
BIOCONTAINMENT AND I WANTED TO
HEAR MORE ABOUT THE FUTURE, LEE
DOUGH MANNED AT YOUR
INSTITUTIONS BUT NOT ZERO
DEMAND.
IS THERE A TRADE IMPROVE TO
CENTRALIZE, SUCH AS CENTERS OF
EXCELLENCE, OR IS THAT
CONSOLIDATING EXPERTISE IN WAYS
THAT ARE DETRIMENTAL TO THE
UNIVERSITY OR OTHER SETTING IN
WHICH THIS TAKES PLATES.
>> I MIGHT JUST START OFF, BUT
I'M INTERESTED IN WHAT THE
OTHERS HAVE TO SAY.
PART OF THE SECRET SAUCE TO AN
INSTITUTION IS IT'S VERY
DECENTRALIZED AND BROAD.
AN INVESTIGATOR CAN COME HERE,
HAVE A GOOD IDEA AND GET IT
FUNDED THEY CAN DO IT.
IF WE DON'T HAVE A BSL3 YOU
CAN'T DO IT.
MAYBE THERE IS SOME VALUE IN
JUST SAYING OUR INSTITUTION
DOESN'T FOCUS ON INFECTIOUS
DISEASE RESEARCH.
OUR BREAD AND BUTTER IS
ROBOTICS, OR SOMETHING LIKE
THAT, WHEN WE PROMULGATE
POLICIES, IT DRIVES THE RESEARCH
TO PLACES THAT CAN IMPLEMENT THE
POLICY.
>> I WANT TO MAKE SURE I ANSWER
WHAT YOU'RE ASKING.
WOULD YOU ASK IT AGAIN PLEASE?
>> I THINK IT WAS JIM THIS
MORNING, I APOLOGIZE IF I'M
INCORRECT, CENTRALIZING
RESOURCES AROUND BIOCONTAINMENT,
HAVING SOME CENTRAL MODELS.
THE QUESTION HERE IS THINKING
ABOUT THE FUTURE, DO WE HAVE
POLICIES WHERE WE PRIORITIZE
PEOPLE WHO HAVE THE ABILITY TO
DO THIS RESEARCH OR DO WE
PRIORITIZE THIS GROUNDSWELL.
SO HEARING THE TRADEOFF, DO WE
WANT TO, AS WRIST MENTIONED, BE
MORE CONSCIOUS OR ALLOW IT TO BE
AN INVERTANCE OF POLICY.
>> DIFFICULT TO LIMIT IT TO
CERTAIN PLACES OR INSTITUTIONS,
BECAUSE I THINK ABOUT US, LIKE
TO CHRIS' POINT, WE -- IF
SOMEBODY WANTS TO DO SOMETHING
AND WE CAN ACCOMMODATE, WE'LL DO
IT.
THERE ISN'T MUCH MORE.
THE ONLY LIMITING FACTORS WOULD
BE DO WE HAVE THE CONTAINMENT
FACILITIES TO DO THAT.
AT OUR INSTITUTION IF WE DIDN'T
HAVE THE ABILITY, WE WOULD DO IT
AND BUILD IT.
I WORRY IT'S U.S.-CENTRIC.
GRANTED THIS IS THE GOVERNMENT.
I'M NOT SURE OTHER PLACES IN THE
WORLD WOULD STOP IT.
I WON'T SEE ANY MORE THAN THAT
BUT IT WOULD BE CHALLENGING.
>> WE'RE COMING CLOSE TO TIME.
GERRY, FINAL QUESTION FOR THIS
PANEL.
>> BOY.
MOST HAS BEEN SAID.
MAYBE ONE QUICK LIGHTNING ANSWER
FROM ALL, WHAT WE'RE HEARING
TODAY IS DURC IS RIGHT NOW LIST
BASED, AND SEVEN EXPERIMENTS,
ESSENTIALLY P3CO ALMOST A SUBSET
OF DURC, WHAT ARE YOUR THOUGHTS,
LIGHTNING ANSWER, HOW THOSE
WOULD LOOK TO INTEGRATE, OR IS
THERE BENEFIT TO INTEGRATING
THOSE?
>> I'LL GO FIRST.
YES.
I DEFINITELY THINK THERE WOULD
BE BENEFIT.
I CARE ABOUT HAVING TOO MUCH
BUREAUCRACY, TOO MUCH
REDUNDANCY.
WE HAVE LIMITED STAFF.
WE NEED TO KNOW EXACTLY WHAT WE
NEED TO DO AND JUST DO THAT AND
HAVING TO DO IT MULTIPLE TIMES
FOR DIFFERENT AGENCIES IS
RIDICULOUS, SO YES.
>> YOU NEED A COMMON USG, NOT
HHS OR DoD OR USDA, SOMETHING
THAT WOULD BE HARMONIZED.
>> YES, BECAUSE THINK ABOUT IT.
IF I DO THIS WORK AND CDC
INSPECTS, NIH DECIDES TO
INSPECT, WE MAY ALSO HAVE A
DoD GRANT WHERE THEY DECIDE TO
INSPECT, A LOT OF PAPERWORK, A
LOT OF INSPECTION, TIME WASTED
TO WHAT BENEFIT?
>> CHRISTOPHER, JENNIFER, WANT
TO COMMENT?
>> DEFER TO DAVID WHO IS ON THE
GROUND IN THESE SITUATIONS.
>> I'LL JUST SAY I'VE THOUGHT
THE GAIN OF FUNCTION STUDIES IN
QUESTION WERE A TYPE OF DURC,
SUBSET OF DURC MAYBE, IT
PROBABLY MAKES SOME SENSE TO
COMBINE POLICIES.
I DON'T KNOW HOW TO DO IT YET
BUT ANY APPROACH WHERE A
FUNDING AGENCY TO IDENTIFY
SOMETHING OF HIGH CONCERN AND
SAY WE WANT TO FUND THIS, WE
THINK IT'S DURC, WE BROUGHT TO
BEAR EXPERTISE TELLING US IT IS,
YOU OF I -- YOU AT THE
INSTITUTION, I WANT YOU TO BE
AWARE AND MANAGE IT, ESPECIALLY
IF IDENTIFIED AT TIME OF
FUNDING.
>> THANKS.
NO FURTHER QUESTIONS FROM ME.
>> I WANT TO THANK IF I -- THIS
PANEL, WITH PARTICIPANTS ILL,
COMING OFF VACATION, WE
APPRECIATE YOUR WILLINGNESS TO
JOIN US.
THANK YOU VERY MUCH FOR YOUR
THOUGHTS.
WE HAVE A LITTLE BIT OF TIME FOR
SOME CLOSING THOUGHTS.
I WOULD LOVE TO INVITE GERRY AND
RACHEL TO GIVE SOME THOUGHTS
ABOUT TODAY AND SOME MAYBE
THEMES OR INTERESTING CONCEPTS.
GERRY, DO YOU WANT TO START?
>> SURE.
BOY, IT WAS A LOT.
A GOOD DISCUSSION, HARD WORK.
THESE ARE HARD POLICIES.
THERE'S A REASON MAYBE DURC WAS
ORIGINALLY LIST BASE, 15 SELECT
AGENTS.
IT'S DIFFICULT TO GET BEYOND
LIST BASE.
WE'RE IN A BIT OF SPACE WHERE WE
RECOGNIZE MAYBE A LIST BASE IS
NECESSARY, NOT SUFFICIENT, SO WE
ARE GOING TO HAVE TO FIGURE OUT
HOW TO MOVE FORWARD WITH A RISK
BASE IN ADDITION TO LIST BASE,
THAT'S GOING TO REQUIRE SOME
THOUGHTFUL CONSIDERATION BUT I
HEARD PEOPLE SAYING THAT TODAY.
JIM LE DUC PROVIDED A LOT OF
THINGS, A ROAD MAP TO A WAY
FORWARD.
WE NEED TO PAY ATTENTION TO A
LOT OF THINGS JIM LAID OUT.
THERE'S SOME REALLY GOOD
EXAMPLES OF HOW A COUPLE
UNIVERSITIES, UNIVERSITY OF
CHICAGO, UTMB, ACTUALLY WORK
IBCs THAT ARE VERY IMPORTANT.
WE'RE PUTTING A LOT OF WORK, A
LOT OF RESPONSIBILITY ON OUR
IBCs, AT THE INSTITUTION
LEVEL.
I ALSO AGREE WITH JIM WE'VE GOT
TO UPREGULATE, ON PAR WITH IACUC
AND HUMAN RESEARCH, PROBABLY
HAVE TO TAKE A LOOK AT QUALITY
CONTROL OF THE IBCs ACROSS
UNIVERSITIES AND MOVE BEYOND
UNIVERSITIES AND BEYOND FEDERAL
FUNDING INSTITUTIONS, WE'LL HAVE
TO GIVE THAT CONSIDERABLE
THOUGHT.
MAYBE MY FINAL THOUGHT, I
STRUGGLE WITH THIS.
CHRISTOPHER SAID IT IN THE LAST
PANEL, TENSION BETWEEN
THEORETICAL AND PRACTICAL
IMPLEMENTATION.
AND IN REALITY A LOT OF THINGS
WE SAID TODAY ARE NOT NEW.
BUT THE PRACTICAL IMPLICATION IS
REALLY HARD BUT WE'VE GOT TO GET
BEYOND THAT THEORETICAL TO
PRACTICAL IMPLICATION AND IT
WON'T HAPPEN OVERNIGHT BUT WE'VE
GOT TO ACCELERATE THAT JOURNEY.
I'LL STOP AND DEFER TO RACHEL.
>> SURE.
ACTUALLY, GERRY, YOU WENT WHERE
I WAS DEBATING GOING AND DECIDED
NOT TO, IN TERMS OF INTEGRATING
OR HARMONIZING P3CO AND DURC AND
I WOULD ADD INTO THAT SELECT
AGENT PROGRAM.
WE HAVE -- MAYBE OTHERS BUT
THOSE THREE DEFINITELY.
SIMON ANTHONY RAISED MY
CONSCIOUSNESS ABOUT GRAY AREA
RESEARCH.
THAT REALLY BEGS FOR THE
INTEGRATION AND DISCUSSION AND
TRAINING AND SORT OF THOUGHT
PROCESS ABOUT WHAT IS OF
CONCERN.
WHEN WE SAID WE'RE GOING TO DO
AN UPDATE ON DURC, I KEPT GOING
BACK TO "OF CONCERN."
HOW CAN WE DEFINE THAT IN A
RATIONAL WAY?
AND I THINK IF WE DO THAT WE
START THERE, THE TRAINING PART,
CONSCIOUSNESS RAISING COMES WITH
THAT.
THE POINT ABOUT NIH HAVING
PROVIDED MORE OUTREACH AND
TRAINING RESOURCES, I LOOKED AT
THE FAQs AND TRAINING, THAT'S
GREAT.
BUT NOT EVEN EVERYBODY WHO IS
RESPONSIBLE FOR THIS KNOWS THOSE
EXIST, IF WE GOOGLE IT, BUT I
THINK THERE NEEDS TO BE A FULL
COURT PRESS ON THAT DISCUSSION.
AND MAKING IT BROAD, I SPENT A
LOT OF TIME THERE, I DON'T KNOW
IF THAT'S THE PLACE OR HAVE AN
ACADEMY GROUP OR PUBLIC
DISCUSSION, THAT INVOLVES THE
OTHER PLAYERS THAT WE'VE TALKED
ABOUT, WHETHER INDUSTRY DIY,
INTERNATIONAL, THE U.S. CAN SET
AN EXAMPLE.
I THINK IF WE COME UP WITH
SOMETHING THAT MAKES SENSE, THAT
OTHER COUNTRIES WOULD BE
DELIGHTED, SOME AT LEAST, FALL
INTO LINE BUT WE'VE TALKED ABOUT
THE CULTURE OF RESPONSIBILITY,
IF WE DON'T HAVE SOMETHING THAT
MAKES SENSE AND ISN'T VULCANIZED
THEY ARE NOT GOING TO FOLLOW IT.
IT'S A GOOD TIME TO BE
REEXAMINING WHAT WE DO, HOW WE
DO IT, ESPECIALLY HOW WE TRAIN
RESEARCHERS FOR WHEREVER THEY
GO, THEY END UP GOING IN OTHER
COUNTRIES OR IN OTHER
DISCIPLINES AND INDUSTRY.
I THINK IT'S WELL PAST TIME TO
DO THAT.
THIS IS THE WINDOW OF
OPPORTUNITY I THINK THE PANDEMIC
MADE US REEVALUATE WHAT WE
CONSIDER RISK AND BENEFIT FROM
BOTH SIDES AND TAKE ADVANTAGE OF
THAT OPPORTUNITY.
I SEE JIM HAS A HAND UP AND
GOING BACK TO HIS ROAD MAP, A
FITTING PERSON TO GIVE US
ANOTHER POINTER ON THAT.
>> I DID WANT TO EMPHASIZE OR
DRAW ATTENTION TO CHRIS' COMMENT
THAT THEY ARE CONSIDERING
CLOSING DOWN THEIR BSL3
LABORATORY, FOR FINANCIAL
REASONS.
I THINK THIS JUST EXEMPLIFIES
THE COST OF THE BIOSAFETY
ASPECTS OF THE CHALLENGES THAT
WE'RE FACING.
AND, AGAIN, IT GOES BACK TO THE
FACT THAT NIH IS ALREADY
INVESTED A BILLION DOLLARS IN
BUILDING THESE BIOCONTAINMENT
LABS, IS THERE A WAY THAT WE CAN
BETTER USE THEM MORE EFFICIENTLY
TO HELP ADDRESS THIS QUESTION.
SO I JUST COULDN'T HELP BUT
COMMENT ON CHRIS.
THANK YOU.
>> IF I COULD ECHO ONE THING
ABOUT SIMON'S POINT ABOUT THE
UNCERTAIN TERRITORY, WE'VE GOT
TO INCORPORATE THAT UNCERTAIN
TERRITORY THAT'S UNKNOWN AND
RISK ASSESSMENT, INTO OUR
POLICIES.
>> THAT'S GOING TO BE ESPECIALLY
CRITICAL, IF IN FACT WE GO
FORWARD WITH A GLOBAL
SURVEILLANCE EFFORT IN SOME
FASHION.
WHAT DO YOU DO WHEN YOU FIND IT?
HOW DO WE CLASSIFY AND HANDLE
IT?
EVEN IF IT'S NOT THE LIVE
ORGANISM BUT SEQUENCE, THAT
BRINGS UP OTHER QUESTIONS ABOUT
DEALING WITH INFORMATION POLICY.
>> AGAIN, EVERYTHING HAS BEEN
SAID BY YOU BOTH, ESPECIALLY
AROUND THE SCOPE.
SOME THOUGHTS AROUND THE NORMS
THAT EVEN AREAS WE DON'T, QUOTE,
REGULATE BUT CAN LEARN FROM AND
IMPLEMENT PRACTICES WOULD BE
VERY IMPORTANT.
THE PART THAT CONTINUALLY
STRIKES ME IS GERRY TALKED ABOUT
PRACTICAL VERSUS THEORETICAL AND
CHALLENGES FOR THE RESEARCH
COMMUNITY TO DEFINE THAT WHICH I
THINK THE PRACTICAL AND
THEORETICAL HAS A MUCH STRONGER
LEVEL OF PRECISION TO IT BUT
WHEN WE HEAR NIH AND PUBLIC
SERVING THE COUNTRY AND MORE HOW
TO DEFINE THOSE IN WAYS THAT ARE
MEANINGFUL AND WE DEVELOP
MITIGATION THAT ADDRESS
PRACTICAL RISKS AND NOT
THEORETICAL BECAUSE THEY ARE
COSTLY AND DON'T PROVIDE
ADDITIONAL BENEFITS.
HOWEVER, THE PUBLIC INVESTMENT
IS WHAT FOOTS THE BILL FOR THIS
RESEARCH SO HOW DO WE
EFFICIENTLY MANAGE THAT, THAT
KIND OF BALANCE.
WITH THAT, I WILL START TO WRAP
US UP FOR TODAY.
AS MENTIONED, THIS IS ONE IN
SEVERAL OF OUR LISTENING
SESSIONS.
AGAIN, WE CONTINUE TO TRY TO
WORK TO ENGAGE MANY SPEAKERS AND
WE'RE ALWAYS LOOKING FOR
FEEDBACK OR OTHER SORTS OF --
SORRY, I'M TRYING TO SHARE MY
SCREEN TO GIVE YOU A PLACE TO
SEND COMMENTS, IF YOU'D LIKE TO
SEND COMMENTS TO THE NIH FOR
CONSIDERATION, WE'RE HAPPY TO
TAKE THOSE AT ANY TIME.
THIS IS ONE OF SEVERAL.
WE'LL BE CONTINUING THIS
CONVERSATION.
WE'LL ALSO WORK HARD TO MAKE
SURE THAT THIS IS ADVERTISED FOR
PEOPLE TO PARTICIPATE AND
COMMENT.
AGAIN, AS PART OF THE BROADER
U.S. GOVERNMENT EFFORT, THIS WAS
VERY FOCUSED ON NIH-SUPPORTED
RESEARCH, WE'RE WORKING IN
TANDEM WITH OSTP INTERNATIONAL
SECURITY COUNCIL AND U.S.
GOVERNMENT PARTNERS TO THINK
ABOUT HOW TO DO THIS IN A
LOCK-STEP APPROACH TO PROVIDE
CONSISTENCY FOR THE RESEARCH
COMMUNITY AS WELL AS APPROPRIATE
OVERSIGHT AND NEXT STEPS.
WE LOOK FORWARD TO CONTINUING
THIS CONVERSATION AND APPRECIATE
EVERYONE WHO TAKE THE TIME TO BE
ON A VIRTUAL MEETING.
WE WISH WE COULD HAVE BEEN IN
PERSON BUT WISH YOU ALL HEALTH
AND SAFETY AND LOOK FORWARD TO
SEEING YOU AGAIN SOON.
WITH THAT, WE ARE CLOSED.