I'M CHAIR OF THE BIOSECURITY FOR
NSABB.
I WELCOME OTHER
MEMBERS OF THE BOARD, FEDERAL
COLLEAGUES, INVITED SPEAKERS AND
MEMBERS OF THE PUBLIC JOINING US
ON THE WEBCAST.
FOR THOSE LISTENING THAT DON'T
KNOW, THE NSABB IS A FEDERAL
ADVISORY COMMITTEE THAT PROVIDES
ADVICE, RECOMMENDATIONS ON
BIOSECURITY OVERSIGHT ON
RESEARCH TO THE UNITED STATES
GOVERNMENT.
NSABB MEMBERS BRING A WIDE RANGE
OF EXPERTISE AND PERSPECTIVES TO
BEAR AND IMPORTANTLY THROUGH
MEETINGS LIKE THIS ONE, THE
BOARD FACILITATES PUBLIC
ENGAGEMENT IN THE POLICY MAKING
PROCESS.
BEFORE I TURN IT OVER TO
DR. JORGENSON OR OPENING
REMARKS, TO NOTES THIS WEBCAST
WILL BE RECORDED AND NIH WILL
POST IT ONLINE SOME TIME AFTER
THE MEETING.
DR. JORGENSON, OVER TO YOU FOR
OPENING REMARKS.
>> THANK YOU, DR. PARKER.
I'M LYRIC JORGENSON THE DIRECTOR
FOR SCIENCE POLICY AT THE
NATIONAL INSTITUTES OF HEALTH
AND I WANT TO THANK THE MEMBERS
AND THE PUBLIC AND THE MEMBERS
OF THE NATIONAL SCIENCE ADVISORY
BOARD FOR BIOSECURITY.
MANY OF YOU KNOW THE NSABB HAS A
DEEP HISTORY OF ADVISING THE
U.S. GOVERNMENT ON POLICY AND IN
FEBRUARY OF THIS YEAR WAS TASKED
BY THE GOVERNMENT TO REVIEW TWO
KEY BIOSECURITY FRAMEWORKS
GOVERNING LIFE SCIENCES
RESEARCH.
SPECIFICALLY A REMINDER THESE
INCLUDED TO EVALUATE AND PROVIDE
RECOMMENDATIONS ON THE
EFFECTIVENESS OF THE CURRENT
OVERSIGHT FRAMEWORK FOR RESEARCH
INVOLVING ENHANCED PANDEMIC
PATHOGENS YOU'LL HERE AS EPPs
AND TO EVALUATE AND ANALYZE THE
FEDERAL GOVERNMENT'S
INSTITUTIONAL AND OVERSIGHT OF
DUEL USE RESEARCH OF CONCERN
REFERRED TO AS DURC.
THERE ARE TWO WORKING GROUPS TO
EVALUATE THE FRAMEWORK.
THE GROUP HAS BEEN BUSY.
WE HELD A NUMBER OF PUBLIC
LISTENING SESSION WHERE'S WE
HEARD FROM STAKEHOLDERS AND THE
PUBLIC AND THE WORK GROUPS HAVE
BEEN WORKING FULL STREAM.
THE DISCUSSION AND INPUT FROM
THE LISTENING SESSIONS HELPED
INFORMING THE NIH AND
DELIBERATIONS.
WE'D LIKE TO THANK ALL THE
PEOPLE WHO PARTICIPATED IN THE
EVENT AND MEMBERS OF THE PUBLIC.
WE'LL HEAR PROGRESS UPDATES FROM
ONE OF THE WORKING GROUPS, THE
P3CO WORKING GROUP ON THEIR
ONGOING DELIBERATIONS TO ADDRESS
THE FIRST PART OF THE CHARGE.
THIS THE ONE FOCUSSED ON THE
OVERSIGHT OF EPP RESEARCH.
IN THE SECOND PART OF THE
MEETING WE'LL HEAR FROM
STAKEHOLDERS AND SUBJECT MATTER
EXPERTS ON COMMUNICATION AND
GOVERNANCE OF RESEARCH WITH
DUEL-USE POTENTIAL WHICH WILL BE
FOLLOWED BY QUESTIONS AND
DISCUSSION WITH NSABB MEMBERS.
ULTIMATELY THEY'LL HELP INFORM
THE WORK OF THE NSABB AS THEY
ADVISE NIH AND THE HHS AND THE
TOTAL OF THE GOVERNMENT IN
THINKING THROUGH THE NEXT STEPS.
THE FIRST OF THE TWO DISCUSSIONS
FOCUS ON THE IMPORTANT ROLE OF
RESPONSIBLE COMMUNICATION AND
MANAGING THE RISKS ASSOCIATED
WITH DUAL-USE RESEARCH INCLUDING
THE CONSIDERATION OF CONTEXT OF
INCREASES RAPID DISSEMINATION OF
SCIENTIFIC RESEARCH METHODS AND
THE RESULT OUTSIDE THE
TRADITIONAL MODEL SUCH AS
JOURNAL PUBLICATIONS ON
SCIENTIFIC CONFERENCES.
THE SECOND PART IS OVERSIGHT AND
GOVERNANCE INCLUDING THE
POTENTIAL STRENGTH AND
WEAKNESSES OF POTENTIALLY AN
INTEGRATED P3CO AND DURC
OVERSIGHT FRAMEWORK.
REALLY THINKING ABOUT THE FUTURE
OF SCIENCE LAND IS NEEDED IN
TERMS OF THE OVERSIGHT FRAMEWORK
AND POTENTIAL HARMONIZATION.
I'D LIKE TO THANK THE EXPERTS
PARTICIPATING IN ADVANCE AND ON
BEHALF OF THE NIH WE'RE
APPRECIATIVE OF THE WORK NSABB
HAS BEEN DOING ON THESE
IMPORTANT CHARGES.
YOU'VE BEEN TANKED WITH
CHALLENGING ISSUES ON A TIGHT
TIME LINE WHICH HAVE NO EASY
ANSWERS.
WE APPRECIATE YOUR TIME AND
EXPERTISE.
WITH THE DELIBERATIONS OF BOTH
WORKING GROUPS UNDERWAY WE
ANTICIPATE THE NSABB WILL BE IN
A POSITION TO MEET AGAIN IN THE
COMING MONTHS TO FORMULATE THE
RECOMMENDATION FOR THE ENTIRETY
OF THE CHARGE.
I WOULD LOVE TO TURN IT BACK TO
YOU, DR. PARKER TO KICK OFF
TODAY'S MEETING.
>> THANKS, DR. JORGENSON.
AND BEFORE WE GET STARTED WE
HAVE A FEW ADMINISTRATIVE TASKS.
I'D LIKE TO TURN IT OVER TO MS.
YOUNG, THE DESIGNATED FEDERAL
OFFICIAL FOR THE NSABB TO REVIEW
CONFLICT OF INTEREST POLICY AND
PROVIDE HOUSEKEEPING REMINDERS.
MS. YOUNG.
>> THANK YOU, DR. PARKER.
AS A MEMBER OF THIS COMMITTEE
YOU'RE SUBJECT TO THE RULES OF
CONDUCT THAT APPLY TO GOVERNMENT
EMPLOYEES.
THE RULES AND REGULATIONS ARE IN
THE STANDARDS OF ETHICAL CONDUCT
OF EMPLOYEES FOR THE EXECUTIVE
BRANCH.
YOU RECEIVED THIS DOCUMENT WHEN
YOU WERE APPOINTED TO THE
COMMITTEE.
AT EVERY MEETING IN ADDITION TO
REMINDING YOU ABOUT THE
IMPORTANCE OF FOLLOWING THE
ETHICS RULES, WE LIKE TO REVIEW
THE STEPS WE TAKE AND ASK YOU TO
TAKE TO ENSURE ANY CONFLICTS OF
INTERESTS ARE ADDRESSED.
AS SCHEDULED INTERVALS YOU
PROVIDE INFORMATION ABOUT YOUR
PERSONAL, PROFESSIONAL AND
FINANCIAL INTERESTS.
WE USE THE INFORMATION AS A
BASIS FOR ASSESSING WHETHER HAVE
YOU ANY REAL POTENTIAL OR
APPARENT CONFLICTS OF INTEREST
THAT COULD COMPROMISE YOUR
ABILITY TO BE OBJECTIVE.
WHILE WE WAVE CONFLICTS OF
INTEREST OF GENERAL MATTERS
BECAUSE WE BELIEVE YOUR INTEREST
WILL NOT AFFECT YOUR
PARTICIPATION.
IF NOT WE ASK YOU TO RECUSE
YOURSELF AND LEAVE THE MEETING.
IF YOU HAVE ANY OTHER QUESTIONS
OUR COMMITTEE MANAGEMENT
OFFICER, MANDY, WILL BE HAPPY TO
ADDRESS THEM.
TO START US OFF WITH
HOUSEKEEPING ITEMS, THIS PUBLIC
MEETING IS BEING VIDEOCAST BY
NIH.
KEEP YOUR MICS MUTED WHEN
THOUGHT SPEAKING.
FOR EACH SESSION WE ASK
PRESENTERS TURN THEIR CAMERAS ON
WHEN SPEAKING AND OTHERS LEAVE
THEIR VIDEO OFF UNTIL THE
DISCUSSION PORTION.
WE'LL USE THE RAISE HAND
FUNCTION IN ZOOM SO USE THAT TO
INDICATE YOUR INTEREST IN
JOINING THE DISCUSSION.
OVER TO YOU.
>> BEFORE WE GET STARTED, I WANT
TO SAY A BIG THANK YOU FOR THE
STAFF AND OFFICE OF SCIENCE AND
POLICY WHEN O PROVIDED SUPPORT
I KNOW THEY HAD LATE NIGHTS WITH
THE TASKS.
THANK YOU AND EVERYBODY IN YOUR
OFFICE.
THANK YOU.
WITH THAT, WE'LL BEGIN WITH AN
UPDATE PRESENTATION WITH THE
CO-CHAIRS OF THE WORKING GROUP
REVIEWING THE P3CO POLICY AND
THE STATUS OF OUR DELIBERATIONS.
AS MENTIONED, THESE ARE STILL
PRELIMINARY AND SOME GROUPS
THINKING REGARDING POTENTIAL
DRAFT RECOMMENDATIONS AND
FINDINGS WERE SHARED PUBLICLY IN
THE INTEREST OF MAXIMIZING
PUBLIC STAKEHOLDER FEEDBACK AS
DELIBERATIONS CONTINUE.
WE'LL HAVE AN OPPORTUNITY TO
HEAR COMMENTS THE PUBLIC AND
THANK YOU TO THOSE WHO DID
PROVIDE PUBLIC COMMENT.
THEY WERE POSTED ON THE NIH
OFFICE OF SCIENCE AND POLICY
WEBSITE PRIOR TO THE MEETING AND
SHARED WITH COMMITTEE MEMBERS.
WE WILL FOLLOW THE PUBLIC
COMMENTS WITH A COMMITTEE
DISCUSSION AND THEN WE WILL HAVE
THE DURC STAKEHOLDER SESSION AND
THE PANELS DISCUSSING RESEARCH
METHODS AND RESULTS AND FUTURE
OVERSIGHT OF DURC AND P3CO.
WITH THAT, WE HAVE THE SLIDES
OFF AND I'LL START THE
PRESENTATION AND THEN TURN IT
OVER TO DR. MADAD.
WE ARE ON SLIDE 1.
GOOD AFTERNOON WITH DR. MADAD I
CO-CHAIRED THE WORK GROUP AND
THERE'S FRAMEWORK FOR P3CO.
OUR OBJECTIVE IS TO SHARE
DELIBERATIONS AND GIVE FEEDBACK
ON PRELIMINARY FINDINGS AND
RECOMMENDATIONS.
I'LL NOTE THEY'RE FAR FROM SET
IN STONE.
THEY RECOMMEND THE CURRENT THINK
OF THE WORKING GROUP AND MEANT
TO PROVIDE A WINDOW TO WHERE WE
MAY GO.
AND THAT SAID THE QUESTIONS,
FEEDBACK AND DISCUSSION RECEIVED
WILL HELP INFORM THE WORKING
GROUP'S CONSIDERATION OR NEXT
STEPS.
THIS SLIDE SHOWS THE WORKING
GROUP MEMBERS WHO HAVE
EXPERIENCED AND EXPERTISE IN
BIOMEDICAL RESEARCH AND DEFENSE
AND VACCINE DEVELOPMENT AND
PREPAREDNESS AND RESPONSE AND
GLOBAL HEALTH ALL BROUGHT TO
BEAR AS WE PREPARE OUR TASK.
THE WORKING GROUP'S TASK
REPRESENTS THE FIRST PHASE OF
THE BROADER CHARGE IN FEBRUARY.
THE NSABB WAS TASKED WITH
EVALUATING THE FRAMEWORK FOR THE
OVERSIGHT OF RESEARCH INVOLVING
THE CREATION, TRANSPORT OR USE
OF POTENTIAL PANDEMIC PATHOGENS
OR ENHANCED PPPs.
THERE'S TWO KEY COMPONENTS OF
THE USG FRAMEWORK AND THEY ARE
FIRST, NUMBER ONE, THE P3CO
POLICY GUIDANCE WHICH OUTLINES
RECOMMENDATIONS FOR FEDERAL
DEPARTMENTS OR IDENTIFICATION
AND OVERSIGHT OF ENHANCED PPP
AND TWO, HHS ACTION AND
IMPLEMENTATION OF THE POLICY
GUIDANCE TO GUIDE DECISIONS
OUTLINED IN THE HHS P3CO
FRAMEWORK.
OUR APPROACH HAS BEEN LARGELY
DIVIDED INTO BALANCING
TRANSPARENCY AND SECURITY AND
CONSIDERATION FOR SUPPORT AND
ENHANCED EPPP RESEARCH AND WHILE
THE RECOMMENDATIONS THAT WILL BE
DISCUSSED LARGELY FOCUS ON THE
P3CO POLICY SCOPE AND THE ISSUES
OF BALANCING TRANSPARENCY AND
SECURITY, THE WORKING GROUP
DELIBERATIONS IS ONGOING ACROSS
ALL THREE TOPIC AREAS INCLUDING
SUPPORT FOR ENHANCED EPPP
RESEARCH INTERNATIONALLY.
THE WORK HAS MET THROUGH
TELECONFERENCE AND IN ADDITION
TO POLICIES THEMSELVES,
DELIBERATIONS THUS FAR INCLUDE
PRIOR NSABB READINGS AND REPORTS
AND THE NSABB'S 2016 FINDINGS
AND RECOMMENDATIONS WHICH INFORM
CURRENT POLICY AND THE JANUARY
2020 NSABB MEETING WHICH
FOCUSSED ON TRANSPARENCY AND
SECURITY ISSUES.
EXPERT AROUND PUBLIC
PERSPECTIVES WERE SHARED ON P3CO
IN APRIL AND JUNE OF THIS YEAR
AND DISCUSSIONS WITH STAFF AND
AGENCIES ON THE TYPES OF
RESEARCH THEY SUPPORT.
EXPERIENCES WITH ePPP
IMPLEMENTATION.
DISCUSSION WITH RESEARCH
INVESTIGATORS AND OTHERS AT
ACADEMIC INSTITUTIONS INCLUDING
RESEARCH COMPLIANCE OFFICES WHO
ARE INVOLVED IN THE CONDUCT AND
OVERSIGHT OF RESEARCH INVOLVING
PATHOGENS.
A BRIEFING FROM NATIONAL
SECURITY EXPERTS AND PUBLIC
COMMENTS SHARED WITH THE BOARD.
NOW, I'D LIKE TO HAND IT OVER TO
MY COLLEAGUE AND CO-CHAIR,
DR. MADAD WHO WILL WALK THROUGH
THE FINDINGS AND DRAFT FINDINGS
AND PRELIMINARY RECOMMENDATIONS.
DR. MADAD.
>> THANK YOU SO MUCH,
DR. PARKER.
>> I'M GOING TO GO THROUGH OUR
RECOMMENDATIONS AND DRAFT
FINDINGS AS DR. PARKER
MENTIONED.
WORK GROUP DEDICATED A
SIGNIFICANT AMOUNT OF TIME
CONSIDERING THE SCOPE OF THE
U.S. GOVERNMENT P3CO POLICY.
NATURALLY I'LL BEGIN THERE.
PER THE OSTP POLICY GUIDANCE OF
ePPP AS A PATHOGEN IS A LIKELY
HIGHLY TRANSMISSIBLE AND LIKELY
CAPABLE OF WIDE AND
UNCONTROLLABLE SPREAD IN HUMAN
POPULATIONS AND LIKELY HIGHLY
VIRULENT AND LIKELY TO CAUSE
SIGNIFICANT MORBIDITY AND ORE
MO
-- OR MORTALITY IN HUMANS.
ENHANCED PPP IS RESULT FROM
ENHANCEMENT OF THE
TRANSMISSIBILITY AND/OR
VIRULENCE OF ANY PATHOGEN.
THIS IS LARGELY IN LINE WITH THE
FINDINGS AND RECOMMENDATIONS IN
THE NSABB 2016 REPORT WHICH HAS
MORE DESCRIPTIONS OF HIGHLY
TRANSMISSIBLE AND HIGHLY
VIRULENT BEGINNING ON PAGE 41.
HOWEVER, DURING OUR
DELIBERATIONS THE WORK GROUP
GRAPPLED WITH WHETHER THE
THRESHOLD REMAINED APPROPRIATE.
RECOGNIZING P3CO POLICY IS AN
ADDITIONAL LAYER OF ENHANCED
REVIEW AND OVERSIGHT OF THE
SUBSET OF PPP RESEARCH DEEMED TO
POSE THE GREATEST RISKS, THERE
ARE OTHER BIOSECURITY AND BIO
SAFETY REGULATIONS, POLICIES AND
GUIDELINES IN PLACE THAT MAY
APPLY TO SUCH RESEARCH, THE WORK
GROUP THINKS THE CURRENT
DEFINITIONS DEFINE A THRESHOLD
THAT SHOULD BE RECONSIDERED.
OUR FIRST PRELIMINARY DRAFT
FINDINGS IS THE P3CO SCOPE WHICH
IS GROUNDED IN THE DEFINITIONS
OF PPP AND ENHANCED PPP IN THE
POLICY DOES NOT ADEQUATELY
CAPTURE PATHOGENS THAT DO NOT
MEET THE THRESHOLD OF LIKELY
TRANSMISSIBLE AND CAPABLE OF
WIDE AND LIKELY SPREAD AND
LIKELY HIGHLY VIRULENT AND CAN
POSE A THREAT TO HEALTH OR
SECURITY.
THE WORK GROUP CONSIDERED THE
FACT THAT WHETHER OR NOT A
PATHOGEN POSES A SEVERE THREAT
TO PUBLIC HEALTH THE CAPACITY OF
HEALTH SYSTEMS TO FUNCTION OR
NATIONAL SECURITY IS A FUNCTION
OF TRANSMISSIBILITY AND
VIRULENCE AND SHARED LESSONS
LEARN FROM THE PAST TWO AND A
HALF YEARS OF RESPONSE TO AND
RECOVERY FROM THE PANDEMIC.
THE RECOMMENDATION IS A
DEFINITION OF PPP AND ePPP
MODIFIED TO INCLUDE HIGHLY
TRANSMISSIBLE PATHOGENS WITH
INCREASED FATALITY RATES AND
THOSE LESS TRANSMISSIBLE BUT
HAVE HIGHER VIRULENCE OR CASE
FATALITY RATES.
SECOND IS FROM THE P3CO
FRAMEWORK.
PER POLICY, WILD TYPE PATHOGENS
CIRCULATING IN OR HAVE BEEN
RECOVERED FROM NATURE ARE NOT
ENHANCED PPPs REGARDLESS OF THE
PANDEMIC POTENTIAL.
ADDITIONALLY, PATHOGENS RESULT
FROM MODIFICATION AND THE
TRANSMISSIBILITY OR VIRULENCE OF
PPPs DURING SURVEILLED
ACTIVITIES INCLUDING SAMPLING
AND SEQUENCING, AN ACTIVITY
ASSOCIATED WITH DEVELOPING OR
PRODUCING VACCINES SUCH AS
GENERATION OF HIGH GROWTH
STRAINS ARE NOT CONSIDERED TO BE
ENHANCED PPPs.
CONSIDERATION OF PPP RESEARCH,
THE WORK GROUP IS OF THE OPINION
THE FOCUS FOR ASSESSMENT SHOULD
BE ON THE POTENTIAL FOR ACTIVITY
TO CREATOR INVOLVE AN ENHANCED
PPP NOT IN THE CON TEXT IN WHICH
THIS ACTIVITY OR MODIFICATION IS
CARRIED OUT.
AS A RESULT WE RECOMMEND ALL
RESEARCH ACTIVITY REASONABLY
ANTICIPATED TO CREATE THE
CREATION, TRANSFER OR USE OF
ePPPs IS SUBJECT TO ADDITIONAL
REVIEW UNDER THE P3CO POLICY
FRAMEWORK.
FURTHERMORE , WHILE MOST THE
ACTIVITIES ASSOCIATED WITH THE
SURVEILLANCE AND VACCINE
DEVELOPMENT WOULD NOT BE
ANTICIPATED TO RESULT IN ENHANCE
THE ePPPs AND GENERATION OF HIGH
GROWTH STRAINS, THE CURRENT
EXCLUSIONS AS AWARDED COULD BE
BROADLY INTERPRETED AS BLANKET
EXCLUSIONS.
AND THIS COULD CONCEIVABLY BE
RESEARCH BEING REVIEWED IN
ACCORDANCE WITH P3CO POLICY.
THE WORK GROUP RECOGNIZES THE
IMPORTANT ROLES SURVEILLANCE AND
MEDICAL COUNTER MEASURES
DEVELOPMENT PLAY IN PREPAREDNESS
AND RESPONSE AND ALSO RECOMMEND
THAT PROCESSES BE INSTITUTED FOR
URGENT REVIEW EVALUATION ePPP
CONSIDERED CRITICAL FOR NATIONAL
PUBLIC HEALTH RESPONSE OR
NATIONAL SECURITY.
U.S. GOVERNMENT P3CO POLICY
REQUIRES FEDERAL DEPARTMENTS AND
AGENCIES TO DEVELOP APPROPRIATE
REVIEW MECHANISMS FOR THE
IDENTIFICATION AND OVERSIGHT OF
ENHANCED PPP RESEARCH.
THE HHS P3CO FRAMEWORK OUTLINES
ROLES AND RESPONSIBILITIES OF
HHS FUNDING AGENCIES AND HHS IN
THIS PROCESS.
FOR THE FUNDING AGENCY, THIS
INCLUDES CONDUCTING RESEARCH
MERIT REVIEW, PROVIDING RELEVANT
INFORMATION FOR THE DEPARTMENT
LEVEL REVIEW SUCH AS RISK
BENEFIT ANALYSIS AND PROPOSED
RISK MITIGATION PLAN AND
CONSIDERATION THE
RECOMMENDATIONS FROM THE
DEPARTMENT-LEVEL REVIEW AND
MAKING A FUNDING DECISION.
AT THE DEPARTMENT LEVEL,
RESPONSIBILITIES INCLUDE
CONVENING A MULTI-DISCIPLINARY
REVIEW GROUP AT THE DEPARTMENT
LEVEL TO CRITICALLY EVALUATE THE
PROPOSED WORK AND DEVELOPING
RECOMMENDATIONS AND ACCEPTABLE
FOR HHS FUNDING INCLUDING
SUGGESTIONS FOR ADDITIONAL RISK
MITIGATION MEASURES AND/OR TERMS
AND CONDITIONS OF AWARD IF
AWARDED.
AND WHILE INVESTIGATORS AND
INVESTIGATORS ARE INVOLVED IN
P3CO REVIEW, THE
U.S. GOVERNMENT'S OVERSIGHT
FRAMEWORK FOR ENHANCED PPP
RESEARCH WOULD BENEFIT FROM
ENHANCED ROLES FROM
INVESTIGATORS AND INSTITUTIONS.
INVESTIGATORS AND STUCKSES ARE
CRITICAL COMPONENTS OF A
COMPREHENSIVE SYSTEM AS THEY'RE
MOST FAMILIAR WITH THE RESEARCH
PROPOSED OR BEING CONDUCTED IN
THEIR FACILITIES AND ARE IN THE
BEST POSITIONS TO PROMOTE AND
STRENGTHEN RESPONSIBLE CONDUCT
AND ENSURE ONGOING BIOSAFETY AND
BIOSECURITY CONTROLS AND THE
RECOMMENDATION IS IT BE REVISED
TO INCLUDE ROLES,
RESPONSIBILITIES AND
EXPECTATIONS FOR INVESTIGATORS
AND INSTITUTIONS IN THE REVIEW
OR EVALUATION OF ENHANCED PPP
RESEARCH.
IN DOING SO, THE U.S. GOVERNMENT
SHOULD CONSIDER WAYS TO
HARMONIZE, STRENGTHEN WHERE
NEEDED AND PROVIDE RESOURCES FOR
LOCAL COMPLIANCE ACTIVITIES.
THE U.S. GOVERNMENT SHOULD
DESIGNATE THE U.S. GOVERNMENT
CONTACT ENTITY TO ASSIST
INVESTIGATORS AND INSTITUTIONS
IN THE REVIEW PROCESS AND TO
PROVIDE OVERSIGHT TO ENSURE AN
ADEQUATE EVALUATION.
THE LAST TWO COMPONENTS OF
RECOMMENDATION 3 WILL BE
SYNERGISTIC WITH THE
RECOMMENDATION OF WORK GROUP 4.
THE ADDITIONAL PROCESS OUTLINED
FOR THE OSTP, P3CO POLICY
GUIDANCE AND HHS P3CO FRAMEWORK
WERE DEEMED TO BE GENERALLY
APPROPRIATE AS DESIGNED.
HOWEVER, THERE ARE A NUMBER OF
AREAS WHERE WE THINK CHANGES TO
THE POLICY FRAMEWORK MIGHT SERVE
TO ENHANCE REVIEW AND OVERSIGHT.
FOR INSTANCE, UNDERSTAND SECTION
3 OF THE OSTP GUIDANCE WHICH
YOUD LINES PRINCIPLES TO BE
SATISFIED BY FEDERAL REVIEW
MECHANISMS, 3.3 AND 3.4 AS
WRITTEN AND SHOWN HERE, WERE
DEEMED TO BE INCONSISTENT WITH
SIMILAR POLICIES AS DESCRIBED IN
THE BELMONT REPORT REGARDING THE
ASSESSMENT OF RISKS AND
BENEFITS.
WHILE IT IS IMPOSSIBLE TO
ELIMINATE ALL RISK, THE WORK
GROUP RECOMMENDATIONS THE
PRINCIPLES BE REVISED IN A
MANNER THAT FOCUSES ON
ALTERNATIVE WAYS OBTAINING THE
BENEFITS RATHER THAN AN
ALTERNATIVE METHODS TO ANSWER
THE SAME QUESTION AND HELPS TO
ENSURE RISKS THAT ARE DEEMED
UNNECESSARY ARE IDENTIFIED.
POTENTIAL REVISIONS TO 3.3 AND
3.4 ARE PROVIDED IN OUR DRAFT AS
ILLUSTRATIVE EXAMPLES ONLY.
ADDITIONALLY, SECTION 4C STATES
TO INVOLVE ANY OF THE SEVEN
EXPERIMENTAL OUTCOMES LISTED.
IN CONJUNCTION WITH OTHER DRAFT
RECOMMENDATIONS, IN PARTICULAR,
PROVIDING ENHANCED RULES AND
RESPONSIBILITY AT THE
INSTITUTIONAL LEVEL AND THE
DEVELOPMENT OF IMPLEMENTATION
GUIDANCE FOR FUNDING AGENCIES,
WE RECOMMEND THE POTENTIAL FOR
SUCH OUTCOMES BE CONSIDERED AT
EACH STAGE OF THE REVIEW
PROCESS.
THE P3CO REVIEW PROCESS CAN BE
ITERATIVE AND CAN TAKE A VERY
LONG TIME.
THE FINAL FUNDING DECISIONS
SOMETIMES COMING A YEAR OR MORE
AFTER THE PEER REVIEW.
THE LENGTHY REVIEW TIMES AND
LACK OF INFORMED EXPECTATIONS
REGARDING REVIEW PROCESS AND
TIME LINE HAVE RESULTED IN
SIGNIFICANT UNCERTAINTY AND
CHALLENGES FOR INVESTIGATORS AND
INSTITUTIONS.
WHILE SOME CHALLENGES ARE
EXPECTED WITH ANY IMPLEMENTATION
OF NEW POLICY, THE WORK GROUP
FOUND THAT A LACK OF
IMPLEMENTATION DIRECTIVE ANDANCE
INCLUDING FROM THE DEPARTMENT TO
FUNDING AGENCIES AND FUNDING
AGENCIES TO INSTITUTIONS
RESPECTIVELY, CONTRIBUTED TO
REVIEW TIMES UNCERTAINTY AND
CHALLENGES.
THIS IS PARTICULARLY TRUE FOR
RESEARCH INVESTIGATORS AND
INSTITUTIONS.
THE WORK GROUP FOUND THE
CHALLENGES HAVE SIGNIFICANT
POTENTIAL TO DISCOURAGE AND IN
SOME CASE HAVE ALREADY
DISCOURAGED INVESTIGATORS FROM
SUBMITTING RESEARCH PROPOSALS
AIMED AT HELPING UNDERSTAND
PANDEMIC PATHOGENS.
LEFT UNCHECKED, THIS COULD
DISCOURAGE YOUNG SCIENTISTS FROM
PURSUING RESEARCH CAREERS IN
AREAS CRITICAL TO PANDEMIC
PREPAREDNESS AND RESPONSE OR
PUSH THEM OR IMPORTANT RESEARCH
OVERSEAS DUE TO UNNECESSARY
DELAYS AND BURDENS AND NEGATIVE
STIGMA.
INVESTIGATORS AND INSTITUTIONS
ARE COMMITTED TO ENSURING
CRITICAL RESEARCH DETERMINE TO
INVOLVE ePPPs RECEIVES ADEQUATE
REVIEW AND STRICT OVERSIGHT.
ADDITIONAL EDUCATION AND
GUIDANCE WOULD FACILITATE MORE
CONSISTENT AND EFFICIENT POLICY
IMPLEMENTATION BY ALL
STAKEHOLDERS AND ENHANCE
AWARENESS MUCH BIOSAFETY AND
BIOSECURITY ISSUES THROUGH THE
LIFE CYCLE.
THE WORK GROUP THUS RECOMMENDS
THE U.S. GOVERNMENT DEDICATES
RESOURCES AND PERSONNEL TO THE
DEVELOPMENT OF IMPLEMENTATION
DIRECTIVE OR PLAN, ADDITIONAL
GUIDANCE, EDUCATIONAL MATERIALS
AND STANDARD OPERATING
PROCEDURES THAT COULD BE ADOPTED
FOR USE BY INVESTIGATORS AND
INSTITUTIONS.
IT'S IMPORTANT SUCH MATERIAL
OUTLINE CLEAR ROLES AND
RESPONSIBILITIES FOR
INVESTIGATORS, INSTITUTIONS,
FEDERAL FUNDING AGENCIES AND
FEDERAL DEPARTMENTS.
THE COMPANION GUIDE AND OTHER
MATERIAL DEVELOPED IN IMPLEM
IMPLEMENTATION OF DURC POLICIES
MAY SERVE AS A MODEL.
AMONG OTHER THINGS, THE WORK
GROUP RECOMMENDS THE GUIDANCE
AND EDUCATIONAL MATERIAL HAVE
CLEAR STEPS, CONSIDERATIONS AND
CRITERIA TO AID CONSISTENT
IDENTIFICATION OF ePPP RESEARCH.
ADDRESS THE TYPES OF RISKS AND
BENEFITS THAT SHOULD BE ASSESSED
AND THE EXPECTED COMPONENTS OF
RISK MITIGATION PLAN AND OTHER
MATERIAL EVALUATED.
INCLUDING SUBSTANTIVE
INFORMATION ON BIOSAFETY AND
BIOSECURITY STANDARDS AND
PROVIDE EXPECTATIONS AND
GUIDANCE ON REASONABLE
COMMUNICATION ON RESEARCH.
AS AN ADDITIONAL CONSIDERATION,
THE U.S. GOVERNMENT SHOULD
DEVELOP PRINCIPLES AND
GUIDELINES THAT CAN BE APPLIED
TO SUBSTANTIATE 1, THERE ARE NO
FEASIBLE SCIENTIFICALLY SOUND
ALTERNATIVE METHODS OF OBTAINING
THE BENEFITS SOUGHT IN THE
RESEARCH IN THE MANNER THAT
POSES LESS RISK.
AND 2, THAT UNNECESSARY RISKS
HAVE BEEN ELIMINATED AND OVER
ALL ASSESSMENT OF REMAINING RISK
FIND THEY ARE ADJUSTED OR
JUSTIFIED BY THE POTENTIAL
BENEFITS TO SOCIETY FROM THE
RESEARCH.
TURNING TO TRANSPARENCY AND
SECURITY.
BASED ON DISCUSSIONS WITH
FEDERAL STAFF, HHS, P3CO REVIEW
GROUP, HAVE THE APPROPRIATE
EXPERTISE REPRESENTED TO REVIEW
THE RESEARCH THAT WAS REFERRED
FOR DEPARTMENT-LEVEL REVIEW.
HOWEVER, WHILE THE HHS P3CO
FRAMEWORK AND EXPERTISE THAT
SHOULD BE REPRESENTED DURING THE
DEPARTMENT-LEVEL REVIEW
INCLUDING SCIENTIFIC RESEARCH BY
SAFETY, BIOSECURITY AND
DEVELOPMENT IN AVAILABILITY,
LAW, ETHICS AND PUBLIC HEALTH
PREPAREDNESS AND RESPONSE AMONG
OTHERS, THE WORK GROUP BELIEVES
INCREASED TRANSPARENCY IS
NEEDED.
SPECIFICALLY, WE RECOMMEND THE
U.S. GOVERNMENT TAKE ADDITIONAL
STEPS TO INCREASE TRANSPARENCY
IN THE REVIEW PROCESS INCLUDING
POTENTIALLY SHARING A SUMMARY OF
KEY DETERMINATES AND DECISIONS
OF U.S. GOVERNMENT REVIEW.
SUCH TRANSPARENCY WOULD BE IN
PART ACCOMPANIED OR ACCOMPLISHED
BY THE DEVELOPMENT AND BELIEFS
OF AN IMPLEMENTATION PLAN AND
GUIDANCE AS OUTLINED IN
RECOMMENDATION 4.
AS PART OF OUR EVALUATION, THE
WORK GROUP CONSIDERED DIFFERENT
TYPES OF RESEARCH SUPPORTED BY
THE U.S. GOVERNMENT INCLUDING
RESEARCH INVOLVING ANIMAL AND
PLANT PATHOGENS.
CONSIDERING P3CO SCOPE IS
FOCUSSED ON A RESULTING PATHOGEN
AND NOT LIMITED BY THE STARTING
PATHOGEN BY WAY OF THE ePPP
DEFINITION, WE SOUGHT THE FOCUS
OF ADDITIONAL P3CO REVIEW ON
PATHOGENS LIKELY TO CAUSE
DISEASE IN HUMANS WAS
APPROPRIATE.
HOWEVER, WORK GROUP MEMBERS ARE
OF THE OPINION IT MAY BE
CONSIDER POLICIES FOR ADDITIONAL
REVIEW AND OVERSIGHT OF RESEARCH
INVOLVING ENHANCED PATHOGENS
LIKELY TO POSE SEVERE THREATS TO
HUMAN HEALTH, FOOD SECURITY,
ECONOMIC SECURITY OR NATURAL
SECURITY BY ITS IMPACTS ON
ANIMALS OR PLANT OR TO ANIMAL OR
PLANT PRODUCTS.
RECOGNIZING THAT SOME ADDITIONAL
INPUTS IN DELIBERATION MAY BE
NEEDED HERE, WE DO NOT YET FRAME
THIS AS A SPECIFIC DRAFT
RECOMMENDATION.
SIMILARLY THE INTEGRATION OF
P3CO AND FRAMEWORKS AS A FINDING
BUT DO NOT FRAME A SPECIFIC
PRELIMINARY RECOMMENDATION.
IN OUR REVIEW AND DISCUSSIONS
PARTICULARLY WITH FEDERAL
FUNDING AGENCIES AND RESEARCH
INSTITUTIONS, IT WAS NOTED
THERE'S SUBSTANTIVE OVERLAPS
BETWEEN THE TWO FRAMEWORKS
INCLUDING INTENT OF OVERSIGHT
AND ENTITIES INVOLVED IN
IMPLEMENTING EACH.
WHILE THEY ACKNOWLEDGE THE
REVIEW AND EVALUATION OF
U.S. GOVERNMENT DURC POLICIES IS
CURRENTLY BEING CONDUCTED BY THE
SECOND WORK GROUP AND THAT
ISSUES OF SCOPE FOR BOTH
OVERSIGHT FRAME WORKS ARE
ACTIVELY BEING DELIBERATED, WE
SUPPORT CONSIDERATION OF POLICY
DIVISIONS INCORPORATING ePPP
RESEARCH IN THE DURC FRAMEWORK.
IN ADDITION TO IN LINE WITH
RECOMMENDATION 4 AND THE NSABB
2016 REPORT THAT RECOMMENDED
P3CO BE INCORPORATED INTO
EXISTING FRAME WORKS WHEN
POSSIBLE AND DURC OVERSIGHT CAN
ENHANCE AWARENESS AND
UNDERSTANDING OF THE ISSUES AS
WELL AS IMPROVE OVERSIGHT.
HOWEVER, IT REMAINS IMPORTANT
FOR THE PRINCIPLES TO UNDER PIN
MANY OF OUR PRELIMINARY
RECOMMENDATIONS REGARDING P3CO
TO RECEIVE ADEQUATE
CONSIDERATION AND ANY POTENTIAL
MERGING OF THE FRAME WORKS.
ADDITIONALLY, CARE SHOULD BE
TAKEN TO ENSURE OVERSIGHT
PROCESSES AND RISK MITIGATION
MEASURES COMMENCE WITH THE
DEGREE OPPOSED TO MINIMIZE
BURDENS AND IMPACT ON THE
RESEARCH ENTERPRISE AND LOOKING
FORWARD TO THE PRESENTATION AND
DISCUSSION LATER TODAY ON
GOVERNANCE OF DUAL-USING
RESEARCH WHERE WE CAN EXPLORE
THE ISSUE SOME MORE.
WITH THAT, ON BEHALF OF THE
WORKING GROUP I THANK YOU FOR
YOUR ATTENTION.
I'LL HAND IT BACK TO DR. PARKER.
>> WE'LL TURN TO THE PUBLIC
COMMENT PORTION OF THE MEETING
AND A WANT TO THANK IN ADVANCE
FOR THE PEOPLE WE'LL BE HEARING
FROM FOR TAKING THE TIME TO
PROVIDE THEIR INPUT.
I'LL HAND THE TO LESLIE WILSON
MODERATING THIS PORTION OF THE
MEETING.
THE FLOOR IS YOURS.
>> OUR FIRST PUBLIC COMMENTER IS
DR. RICHARD EBRIGHT.
HAVE YOU THREE MINUTES TO
PRESENT AND THE TIMER WILL BEGIN
NOW.
>> THE CART OVERSIGHT RESEARCH
OF ePPP RESEARCH HAS SIX
SERIOUS DEFECTS.
THE CURRENT SYSTEM OF OVERSIGHT
OF POTENTIAL PANDEMIC RESEARCH
HAS SIX SERIOUS DEFECTS.
MOVING FORWARD ANY EFFECTIVE OF
OVERSIGHT MUST REMEDY THESE
DEFECT.
FIRST AND MOST IMPORTANT,
CURREN
CURRENTLY UNFORTUNATELY, I'M
RECEIVING AN ECHO.
ALMOST NO ePPP RESEARCH UNDER
GOES THE RISK RESEARCH MANDATED
BECAUSE FEDERAL FUNDING AGENCIES
FAIL TO FORWARD ePPP RESEARCH
PROJECTS TO THE COMMITTEE FOR
REVIEW.
IN THE SIX YEARS SINCE
IMPLEMENTED ONLY THREE ePPP
PROJECTS UNDERWENT REVIEW BY THE
COMMITTEE.
MOST ePPP PROJECTS INCLUDING THE
PROJECT ON ENHANCED SARS-RELATED
CORONAVIRUSES IN WUHAN THAT
COULD HAVE TRIGGERED THE
PANDEMIC WERE NOT FORWARDED AND
DID NOT UNDER GO REVIEW BY THE
P3CO COMMITTEE.
ALL ePPP RESEARCH SHOULD UNDER
GO THE RISK BENEFIT REVIEW
MANDATED AND ALL PROJECTS
AUTOMATICALLY AND WITHOUT
EXCEPTION SHOULD BE REVIEWED BY
THE ePPP COMMITTEE.
SECONDLY, OVERSIGHT OF ePPP
RESEARCH COVERS ONLY RESEARCH
INSTITUTIONS THAT RECEIVE
FEDERAL FUNDING.
RESEARCH INSTITUTIONS THAT DO
NOT RECEIVE FEDERAL FUNDING ARE
NOT COVERED.
BY RECOMMENDATION, OVERSIGHT OF
ePPP RESEARCH SHOULD COVER ALL
INSTITUTIONS IRRESPECTIVE OF
FUNDING SOURCE.
THIRD, CURRENTLY THERE ARE NO
REGULATIONS WITH FORCE OF LAW
FOR OVERSIGHT OF ePPP RESEARCH.
DECISIONS OF THE ePPP COMMITTEE
ARE NOT BINDING AND COMPLIANCE
IS NOT MANDATED, MONITORED OR
ENFORCED.
MY RECOMMENDATION OVERSIGHT OF
ePPP RESEARCH SHOULD BE CODIFIED
IN REGULATIONS WITH FORCE OF LAW
AND MANDATED, MONITORED AND
ENFORCED.
FOURTH, CURRENTLY THE P3CO
COMMITTEE OPERATES WITH COMPLETE
NON-TRANSPARENCY AND COMPLETE
UNACCOUNTABILITY.
THE NAMES AND ACTION
AFFILIATIONS OF ITS MEMBERS HAVE
NOT BEEN DISCLOSED AND
PROCEEDINGS HAVE NOT BEEN
DISCLOSED AND DECISIONS
NOT CLOSED.
MY RECOMMENDATION, OVERSIGHT OF
ePPP RESEARCH SHOULD BE
TRANSPARENT AND ACCOUNTABLE.
FIFTH, CURRENTLY RISK BENEFIT
REVIEW OF ePPP RESEARCH EXCLUDE
REPRESENTATION FROM THE PUBLIC
DESPITE THE FACT THE RISKS AND
BENEFITS OF ePPP RESEARCH
DIRECTLY IMPACT THE PUBLIC
CLEARLY MAKING THE PUBLIC A
STAKEHOLDER.
MY RECOMMENDATION, OVERSIGHT OF
ePPP RESEARCH SHOULD INCLUDE
REPRESENTATIVES OF THE PUBLIC.
SIXTH CURRENTLY RESPONSIBLE FOR
OVERSIGHT OF ePPP RESEARCH IS
ASSIGNED TO FEDERAL FUNDING
AGENCIES THAT PERFORM FUND AND
FUND RESEARCH THAT CONSTITUTES
AN INHERENT CONFLICT OF
INTEREST.
MY RECOMMENDATION OVERSIGHT
SHOULD BE ASSIGNED TO A SINGLE
INDEPENDENT FEDERAL AGENCY THAT
DOES NOT PERFORM RESEARCH AND
DOES NOT FUND RESEARCH.
THANK YOU FOR THE OPPORTUNITY TO
COMMENT.
>> THANK YOU, DR. E BRIGHT.
THE NEXT PUBLIC COMMENTER IS MS.
ANNA PABRISI.
>> I'D LIKE TO THANK THE
ADVISORY BOARD FOR ALLOWING ME
TO ADDRESS YOU.
I'M AT GEORGETOWN SECURITY FOR
EMERGING TECHNOLOGY.
WE PROVIDE NON-PARTISAN ANALYSIS
AND GIVEN THE RECOMMENDATIONS ON
BIOSECURITY OVERSIGHT, YOU KNOW
NEW DEVELOPMENTS IN BIO TECH
CREATE OPPORTUNITIES AND THE
ASPECTS OF THE RESEARCH PUSH
SOCIETAL NORMS AND INTRODUCE
RISKS THROUGH THE EXPLORATION OF
DIFFERENT FUNCTIONALITIES NEW
USE OF ANIMAL MODELS AND
ACCIDENTS.
DIFFERENCES IN REGULATIONS CAN
LEAD TO ETHICAL ASYMMETRIES AND
RESEARCH IN ONE REGION COULD BE
EXPLORED IN ANOTHER AND WOULD
POTENTIALLY AFFECT THE ADOPTION
OF TECHNOLOGY AND OFF-SHORING OF
BIO-INDUSTRY TO THE U.S. FOR
THOSE IMPACTING
U.S. COMPETITIVENESS AND
INCREASE THE POSSIBILITY OF
MISUSE.
UNDERSTANDING THE CURRENT
LANDSCAPE OF THE RESEARCH THAT
IS CONSIDERED RISKY SIN SOME
WAYS FINDING THE NEEDLE IN THE
HAYSTACK BUT WE OFTEN DON'T HAVE
THE HAYSTACK.
THERE'S A NASCENT EFFORT
FOCUSSED ON CHARACTERIZING AND
MAPPING RESEARCH AND DUAL-USE
RESEARCH OF CONCERN GLOBALLY.
WE WANT TO USE CAPABILITIES TO
CREATE A MULTI-LAYERED SET OF
SIGNALS TO DETECT AND UNDERSTAND
RISKY RESEARCH INCLUDING GAIN OF
FUNCTION EXPERIMENTS, PATHOGENS
OF PANDEMIC POTENTIAL AND THE
USE OF ANIMAL MODELS, LAB
INFRASTRUCTURE AND GENOMIC DATA.
WE BELIEVE UNDERSTANDING WHICH
GAIN OF FUNCTION IS BEING
EXPLORED BY WHOM AND WHERE AND
HOW IT'S CHANGING OVER TIME IS
CREATING THAT HAYSTACK FOR
DECISION MAKERS.
THIS IS A FOUNDATION FOR
UNDERSTANDING THE POTENTIAL
ANOMALIES IN RESEARCH AND
DEVELOPMENT.
ONE ASPECT OF OUR EFFORTS I WANT
TO PLAYING FOR THE BOARD IS OR
YOUR ON PATHOGENS OF PANDEMIC
POTENTIAL AND LOOK AT
RESPIRATORY FAMILY RESEARCH
WORLD.
FOR THIS PROJECT, WE
INVESTIGATED THE RESEARCH AND
DEVELOPMENT LANDSCAPE USING THE
OPEN SOURCE DATA HOLDINGS.
WE EXAMINED CLINICAL TRIALS AND
MEDICAL COUNTER MEASURES AND
FURTHER ANALYZED BY COUNTRY AND
EXAMINED TRENDS IN RESEARCH AND
DEVELOPMENT OVER TIME.
WE'RE HAPPY TO PROVIDE
ADDITIONAL INFORMATION TO THE
BOARD AND WILL BE HOLDING A
WEBINAR TOMORROW ON OUR WORK ON
PATHOGENS OF PANDEMIC POTENTIAL.
THANK YOU VERY MUCH.
>> THANK YOU.
THAT ENDS OUR PUBLIC COMMENT FOR
THIS MEETING.
>> THANK YOU, MS. WILSON.
I'LL TAKE THE MIC BACK.
NOW, WE HAVE TIME FOR OPEN
DISCUSSION BY THE NSABB MEMBERS.
ANY THOUGHTS, COMMENTS FROM
MEMBERS ON THE NSABB AND PLEASE
USE YOUR HAND FUNCTION.
I'M NOT SEEING ANY HANDS.
>> I WANTED TO EMPHASIZE THAT
SOME OF THE COMMENTS WE HAVE
SEEN AS A RESULT OF THE
RECOMMENDATIONS, CONCLUSIONS,
ARE BROADER THAN THE REMIT OF
THIS PART OF THE WORKING GROUP.
SO FOR THOSE OF YOU OUT THERE
THAT THINK WE JUST MISSED THINGS
LIKE IS THE OVER ALL
ORGANIZATION OF THE
U.S. GOVERNMENT AND FOREIGN
INVOLVEMENT AND FUNDING OF
CONTROL OR OVERSIGHT OF
INSTITUTIONS THAT ARE NOT FUNDED
BY THE U.S. GOVERNMENT, WE HAVE
NOT FORGOTTEN ABOUT THOSE.
THOSE ARE ON THE AGENDA AND
WE'RE GOING TO DEAL WITH ALL OF
THEM OVER THE NEXT THREE MONTHS
OR AS WE RAMP UP THE SECOND HALF
OF THIS STUDY ON USING DURC AND
THEN TRYING TO COMBINE THEIR
CONCLUSIONS WITH THE CONCLUSIONS
OF DR. PARKER'S AND DR. MADAD'S
WORKING GROUP HERE.
SO WE'RE ALSO CONCERNED ABOUT
THE FACT IF WE OVERREGULATE IN
THE UNITED STATES ALL WE'LL DO
IS PUSH NON-REGULATED RESEARCH
OVERSEAS AND WE HAVE TO DEAL
WITH THAT ISSUE.
THE OTHER HAS BEEN MENTIONED
JUST NOW IS THAT WE HAVE TO DEAL
WITH THE PROBLEM OF DOMESTIC
RESEARCH NOT FUNDED BY THE
FEDERAL GOVERNMENT AND
RECOMMENDATION TO DEAL WITH THAT
WOULD BE MOST APPRECIATED.
WE SAY ONE THING, THERE'S A
PANDEMIC TREATY THAT'S GOING TO
BE GENERATED IN GENEVA AND AS
PARTS OF THAT THERE'S INTEREST
IN HAVING A SECTION IN THAT
TREATY THAT INVOLVES BEST
PRACTICES REGARDING ePPP AND
OTHER POTENTIALLY DANGEROUS
RESEARCH.
I THINK IT'S AN OPPORTUNITY FOR
FOREIGN POLICY DEPARTMENTS AND A
NUMBER OF GOVERNMENTS TO COME TO
AGREEMENT ON THIS LEVEL AND A
POLICY STATEMENT GET INVOLVED IN
THE RESEARCH COMMUNITY OF THE
PANDEMIC TREATY THAT'S CURRENTLY
BEING NEGOTIATED IN GENEVA.
WITH THAT I'LL STOP.
>> THANK YOU, DR. BERNARD.
THANK YOU FOR BRINGING THAT UP.
IT'S IMPORTANT FOR EVERYBODY TO
REALIZE WHAT OUR SCOPE IS AND
WHERE OUR SCOPE IS NOT AND OUR
SCOPE IS PRETTY FOCUSSED ON THE
TWO POLICIES P3CO AND DURC.
NOT THE OVER ALL COMPREHENSIVE
BIOSAFETY, BIOSECURITY FRAMEWORK
IN THE UNITED STATES AND IT FITS
IN THE BIGGER FRAMEWORK BUT IT'S
ONE PART OF THAT FRAMEWORK AND
IT'S IMPORTANT TO NOTE THE
WORKING GROUP IS STILL -- THIS
IS JUST OUR PRELIMINARY FINDINGS
AND RECOMMENDATIONS AND WE STILL
HAVE BIG ISSUE TO GRAPPLE WITH
WHILE WORKING GROUP 2 IN DURC
HAS BEGUN THEIR WORK AND AT SOME
TIME THE TWO WILL COME TOGETHER
AS WE CONTINUE TO WORK ON THIS.
DR. DENNISON.
>> I FIND IT INTERESTING THERE'S
AN AGREEMENT AND THERE'S
PUBLICATIONS AS WELL POTENTIAL
TO REPRESENT POTENTIAL PANDEMIC
PATHOGEN OR ePPP RESEARCH.
THERE'S A METHODOLOGY SINCE
WE'RE STRUGGLING WITH WHAT THOSE
SHOULD BE.
THAT PERHAPS PRESENTS AN
OFF-WORRY CONCERN THERE MAY BE
INDEPENDENT LISTINGS OF THINGS
CONSIDERED TO BE OF CONCERN AND
OF POTENTIAL FOR ANY KIND OF
EFFECT ON THE INVESTIGATORS TO
FOLLOW RESEARCH.
A COUPLE THINGS THAT HAVE COME
UP IN THE COMMENTS RELATED ALSO
THE ISSUES ASSOCIATED WITH
PUBLISHING BIO INFORMATICS
ANALYSES AND THE IMPACT OF THE
PUBLICATION.
I ALSO DIDN'T HEAR COMMENTS AND
ISSUES OR COMMENTS ASSOCIATED
WITH REALLY HOW WE TRULY DEFINE
RISK AND BENEFIT AND AS I LISTEN
TO MORE AND MORE COMMENTS I HEAR
RISK BEING SOMETHING THAT IS
BEING VIEWED AS ANYTHING THAT
MIGHT HAPPEN POTENTIALLY AND
BENEFIT HAVING TO BE PROOF AND
GO TO SCIENTIFIC PROGRESS AND IN
WHAT KINDS OF THINGS WOULD BE
INCLUDED IF WE INCLUDE SUCH A
BROAD BRUSH.
FINALLY, ONE COMMENT, THERE'S NO
DATA THAT SUPPORTS THAT THE
U.S.-GOVERNMENT FUNDED RESEARCH
LED TO THE PATHOGEN RESULTING IN
THE PANDEMIC.
I'M SURE THAT WAS UNINTENDED BUT
THAT'S IMPORTANT TO CORRECT.
I JUST WANT TO SUPPORT THAT.
>> THANK YOU.
DR. LEVINSON.
>> IT'S USEFUL TO REPORT TO THE
BOARD AND THOSE LISTENING A
NUMBER OF RECOMMENDATIONS THE
WORKING GROUP WERE ABLE TO PUT
IN WRITING STEMMED FROM
DISCUSSIONS WITH STAKEHOLDERS
AND THOSE AFFECTED BY THE
REVIEWS THEY UNDERWENT FOR
RESEARCH AND HOPED TO CONDUCT.
THERE'S CONCERN ABOUT THE
POTENTIAL FOR NEW POLICY CHANGES
AND ONES WE HAVE IN PLACE TO
IMPACT THE RESEARCH WE FEEL AND
EVERYONE FEELS IS IMPORTANT FOR
PUBLIC HEALTH AND SAFETY.
AS A RESULT WE HEARD THE
GUIDANCE WAS HELPFUL AND THE
IMPLEMENTATION PLAN AND THE
ROLLOUT AND THE MEASURES IN
PLACE TO PROVIDE SUPPORT TO
RESEARCHERS WHO ARE CONSIDERING
RESEARCH AND THOSE APPLYING FOR
FUNDING SHOULD BE TURNED OVER TO
THE P3CO COMMUNITY.
AND THAT IS REFLECTED IN OUR
FINDINGS AND RECOMMENDATIONS.
WE MIGHT ALSO WANT TO CONSIDER
THE POSSIBILITY THAT WE HAVE
SOME PROCESS IN THE ROLLOUT AND
IS LIKE A PHASE 4 REVIEW WHERE
WE LOOK PERIODICALLY AT THE
IMPACT OF COMPLIANCE WITH THE
REGULATIONS WITH THE OVERSIGHT
POLICY OVER ALL.
AND TRY WITHOUT IMPOSING GREATER
BURDEN THROWN REGULATED
COMMUNITY BUT TRYING TO GATHER
INFORMATION ABOUT WHAT THE
IMPACT IS SO WE UNDERSTAND HOW
TO IMPROVE THE OVERSIGHT PROCESS
AND PERHAPS BETTER DEFINE OR
CHANGE OVER TIME AS NECESSARY WE
HAVE PROVIDED THE IDEA THAT
THERE SHOULD BE UPDATES BUT OVER
AND BEYOND THAT, WHAT WILL
INFORM THOSE UPDATES?
HOW DO WE LOOK FORWARD?
WE DON'T KNOW WHAT RESEARCH IS
GOING TO BE GOING ON IN FIVE,
10, 20 YEARS.
THAT PERHAPS SHOULD BE BUILT IN,
IN A WAY TO REFLECT WHAT THE
COMMUNITY IS FEELING AND WHAT
THEIR SUGGESTIONS WOULD BE.
>> THANK YOU.
THAT WAS SOMETHING THAT WAS
DISCUSSED IN 2016 WITH THE NSABB
REVIEW BOARD.
DR. EGEN.
>> THANK YOU AND GREAT WORK BY
THIS WORKING GROUP.
MY COMMENT ALSO INVOLVES THE
FOURTH RECOMMENDATION WHICH I
THINK IS A GREAT IDEA ABOUT THE
COMPANION GUIDE SIMILAR TO
ANOTHER COMMENT.
I WAS WONDERING IF THE WORKING
GROUP HAD CONSIDERED OR IS
PLANNING ON INCLUDING AS PART OF
THIS DOCUMENTATION ON THE ACTUAL
APPLICATION FORMS AND PROGRESS
REPORTS ABOUT ANY POTENTIAL PPPs
IF THAT WAS DISCUSSED.
>> I THINK OUR THINKING AND I
THINK ONE OF THE THINGS WE HEARD
IS ADDITIONAL GUIDANCE AT ALL
LEVELS WAS NEEDED AND HOW THAT
GUIDANCE HAVING A CHECKLIST MAY
BE NECESSARY AND ALSO NOT
SUFFICIENT.
I THINK MORE WORK NEEDS TO BE
DONE TO ACTUALLY FLUSH OUT WHAT
THE ADDITIONAL GUIDANCE WOULD
LOOK LIKE AND WHAT IS NEEDED AND
SOME WILL BE INHERENTLY IN THE
IMPLEMENTATION THE
U.S. GOVERNMENT NEEDS TO DO AND
THE NSABB ADVISES AND THE DURC
GUIDANCE WAS HELPFUL AND I THINK
WE KNEW THAT BEFORE WE BEGAN THE
PROCESS.
IT NEEDS TO BE ANALOGOUS TO A
SIMILAR PROCESS FOR THE P3CO AND
PROBABLY MORE THAN JUST
COMPANION GUIDANCE AS WELL.
MARK.
>> THAT'S AN IMPORTANT COMMENT.
I SPEND TIME THINKING ABOUT
THOSE ISSUES.
ONE WAS THE ISSUE OF GETTING
PAST PEER REVIEW AND TRYING TO
BE SCIENTIFIC AND VALID AND
FEASIBLE AND DOABLE.
AND WHERE YOU INSTITUTE THAT IS
ALSO AN ISSUE FOR NUMBER ONE, I
THINK THE SCIENTIFIC IDEAS, VERY
EARLY SCIENTIFIC IDEAS SOMETIMES
MAYBE ONES THAT DON'T HAVE MERIT
AND SOME THAT HAVE MERIT AND
THIN REVIEW IT.
I THINK WE'RE STILL OPEN IN THE
CONCEPT BUT WE WERE -- I WILL
SAY CAUTIOUS ABOUT THE
RECOMMENDATION FOR
PRE-SUBMISSION REVIEW THINKING
ABOUT THE HERCULEAN TASK AND
THIS COULD BE CHANNELLED WITH A
GRANT CONSIDERED TO BE
MERITORIOUS FROM THE SCIENTIFIC
PERSPECTIVE.
WE DID SPEND TIME ON THAT.
>> EVEN I THINK IN THE LISTENING
SESSION --
>> WE HAD ONGOING RESEARCH AND I
SAW DR. EBRIGHT'S COMMENTS WERE
FOCUSSED A LOT ON THE P3CO AN
TALKED ABOUT THE PATHOGEN USE ON
AN ONGOING BASIS SHOULD BE AT
THE LOCAL LEVEL AND WOULD HELP
THE INVESTIGATOR UNDERSTAND THE
PROCESS AND POTENTIAL MITIGATION
STEPS AND THAT WAS A
RECOMMENDATION AND I WANTED TO
POINT OUT THAT WOULD BE A CHANGE
IN THE CURRENT POLICY AND THE
LOCAL GUIDANCE ON HOW TO DO THAT
AND OVERSIGHT TO ENSURE THEY ARE
DOING THAT.
>> THERE WAS DISCUSSION AND WE
HEARD IT IN THE LISTENING
SESSION, THE PUBLIC LISTENING
SESSIONS HOW DO YOU COUPLE
GUIDANCE WITH ACCOUNTABILITY
WITH A COMPREHENSIVE OVERSIGHT
AND ONGOING IS AN OPERATIVE WORD
AS WELL WE PICKED UP ON IN OUR
DISCUSSIONS AND REVIEWS SO IT'S
A TOP-DOWN AND BOTTOM-UP AND
THEY KNOW BEST THEIR
CAPABILITIES AND HOW TO ENHANCE
THE CULTURE OF RESPONSIBILITY IN
THEIR INSTITUTIONS AND
LABORATORIES.
LABORATORY LEADERSHIP IS
ESSENTIAL AND INSTITUTIONAL
LEADERSHIP AND TOP-DOWN GUIDANCE
AND OVERSIGHT IS ESSENTIAL AS
WELL.
I DON'T REMEMBER IF ALEX OR
KENNETH WAS FIRST BUT I'LL GO TO
ALEX FIRST SINCE YOU'VE ALREADY
TALKED, KEN.
>> THANK YOU, MY COMMENTS
FOLLOW-UP ON WHAT WAS SAID.
IT'S IMPORTANT TO SAY WE HAD HAD
THAT DISCUSSION ABOUT THE
IMPORTANCE OF LOCAL OVERSIGHT
AND MAKING SURE THAT LOCAL
REVIEW AND KNOWLEDGE ABOUT
CAPABILITIES IS INCLUDED IN THE
REVIEW OF THESE PROPOSALS BUT
IT'S ALSO IMPORTANT TO SAY
UNLIKE OTHER RESEARCH THAT'S
LIKELY TO HAVE EFFECT THAT'S ARE
LOCAL, SO MOST RESEARCH OF HUMAN
SUBJECTS TENDS TO AFFECT THE
PARTICIPANTS IN THOSE STUDIES.
YOU CAN'T HAVE BYSTANDER RELATED
RESEARCH THAT AFFECTS FRIENDS
AND FAMILY.
RESEARCH IS DEALING WITH
PATHOGENS THAT ARE POTENTIALLY
PANDEMIC PATHOGENS HAVE EFFECTS
THAT REACH BEYOND THE LOCAL
INSTITUTION AND PERHAPS EVEN
BEYOND THE LOCAL NATION.
AND SO THE RATIONALE FOR A MORE
CENTRALIZED TOP-DOWN AS YOU WERE
SAYING, REVIEW, I THINK IS
STRONGER BECAUSE THE RISK
TOLERANCE OF CERTAIN COMMUNITIES
MAY NOT BE AS IMPORTANT AS THE
UNIFORM ENFORCEMENT OF AS SET OF
RULES THERE TO ENSURE WE
MITIGATE THE PROSPECTS OF SOME
KIND OF RELEASE.
>> THANKS, ALEX.
DR. BERNARD.
>> I AGREE YOU NEED OVERSIGHT
BUT IT DOESN'T MEAN THE PRIMARY
CONTROL OF THE PROPOSALS NEEDS
TO BE AT THE FEDERAL GOVERNMENT
IT'S A HUGE TASK AND THERE WOULD
BE PUSHBACK FROM LOCAL
RESEARCHERS, I'M SURE.
WHEN THE COMMITTEE WAS CREATED
BACK IN 2004 THE ORIGINAL
CHARTER HAD THE LOCAL IBCs, IRBs
AND LOCAL GROUPS HAVING THE
PRIMARY CONTROL OVER INITIAL
SCREENING FOR DUAL-USE RESEARCH
OF CONCERN AND OTHER DIFFICULTY
ISSUES.
LOCAL IRBs AND IBCs HAVE TO PICK
UP THE SLACK.
THEY DO IT FOR HUMAN SUBJECTS
REVIEW AND FOR DEALING WITH
ANIMALS IN RESEARCH.
IT'S NOT LIKE THERE AREN'T A
STRONG GROUP BUT THERE NEEDS TO
BE A STRONG GROUP IN WASHINGTON
THAT GIVES ADVICE TO THOSE
GROUPS AND MAKE SURE THEY'RE NOT
MAKING DECISIONS AS ALEX WAS
TALKING ABOUT THAT GO AGAINST
WHAT'S GOOD PRACTICES NATIONALLY
OR INTERNATIONAL.
>> THERE WERE RESOURCES AND
PERSONNEL AND THE HARMONIZATION
IS NEEDED.
OTHER QUESTION OR COMMENTS FROM
BOARD MEMBERS?
WORKING GROUP 1, I WANT TO MAKE
SURE HAVE YOU AN OPPORTUNITY.
I'M NOT SEEING -- AM I MISSING
HANDS UP?
I'M NOT SEEING HANDS UP.
GIVEN THAT, I GUESS WE'RE READY
FOR OUR NEXT ITEM ON THE AGENDA
IS A BREAK.
I THINK WE NEED TO STAY ON THE
SCHEDULE AND NOT COME BACK EARLY
BECAUSE I'LL ASK MS. YOUNG IF
THAT'S THE RIGHT THING TO DO AND
ONE OF OUR AFTERNOON SPEAKERS
HAS A TIGHT TIME LINE SO I THINK
WE NEED IT STAY ON THIS AGENDA.
>> I THINK THAT'S RIGHT.
>> OKAY.
SO GIVEN THAT THERE ARE NO MORE
QUESTIONS OR COMMENTS FROM MY
COLLEAGUES ON THE BOARD, LET'S
GO TO THE BREAK AND WE WILL
RESUME AT 2:25, EASTERN TIME,
CORRECT?
ALL RIGHT.
LET'S GO ON BREAK AND IF
EVERYBODY CAN TURN OFF YOUR
VIDEO AND MIC WHILE YOU'RE ON
BREAK.
THANK YOU.
>> I BELIEVE IT'S 2:45.
>> I'M SORRY, 2:45.
THE BREAK ENDS AT 2:45 -- WE'LL
RESUME AT 2:45.
MY APOLOGIES.
WELCOME BACK TO OUR ESSENTIALLY
SECOND SESSION OF THE MEETING
FOR OUR RESEARCH LISTENING
SESSION.
I'M PLEASED NOW TO WELCOME OUR
INVITED SPEAKERS FOR THE
SESSION.
THE SESSION IS FOCUSSED ON
MANAGING BIOSECURITY CONCERNS
WHEN COMMUNICATING RESEARCH AND
CURRENT AND POTENTIAL FUTURE
ROLES AND RESPONSIBILITIES OF
RESEARCH INVESTIGATORS AND
SCIENTIFIC JOURNAL EDITORS,
PUBLISHERS.
THE GOAL IS TO ASSESS POLICIES,
PROCEDURES AND BEST PRACTICES
WHEN IDENTIFYING BIOSECURITY
CONCERNS AND COMMUNICATIONS AND
DISCUSS THE ROLES SO PUBLISHERS
AND SCIENCE COMMUNICATORS
BALANCE TRANSPARENCY AND
BIOSECURITY CONCERNS AND
IDENTIFY BENEFITS WITH ROLES AND
RESPONSIBILITIES IN
COMMUNICA
COMMUNICATING DUAL USE OF
CONCERN.
OU FIRST PRESENTER WILL TALK
ABOUT HIS RESEARCH AND HE WAS AN
INAUGURAL MEMBER OF THE NSABB
AND SERVED UNTIL 2014.
HE'S ALSO SERVED ON VARIOUS
COMMITTEES AT THE NATIONAL
ACADEMIES, NASA AND A STUDY IN
2018 ENTITLED BIO DEFENSE IN THE
AGE OF SYNTHETIC BIOLOGY.
THE ZOOM IS NOW YOURS.
THANK YOU.
>> THANK YOU.
I'D LIKE TO FRAME THE COMMENTS
ON THE CONTEXT OF MY EXPERIENCE
AND ON NSABB AND ALSO IN MY ROLE
AS A JOURNAL EDITOR AND CHIEF AT
THE AMERICAN SOCIETY FOR
MICROBIOLOGY AND MEMBER OF THE
ASM RESPONSIBLE PUBLICATIONS
COMMITTEE.
I THINK YOU ALREADY HEARD OR ARE
ALREADY THINKING ABOUT MANY OF
THE POINTS I'M GOING TO MAKE AS
EVIDENCED BY SOME OF THE EARLIER
DISCUSSION THIS AFTERNOON AND
HOPEFULLY I THINK I'D GO THROUGH
THE HISTORY OF THE NSABB
DISCUSSIONS OF THE H1N1
PUBLICATIONS BECAUSE THAT SORT
OF SETS THE STAGE.
WE TRIED TO COME UP WITH
EXPERIMENTAL RESULT MAY PRESENT
SIGNIFICANT DURC OR BIOSECURITY
THREAT.
I'M USING THE WORD THREAT IN THE
INTENT AND FEASIBILITY.
WE DIDN'T PREDICT ANYTHING LIKE
THE INFLUENZA AND THIS CAME AS A
SURPRISE AND I'LL TALK MORE
ABOUT UNANTICIPATED RESULTS IN A
BIT.
WE SPENT MANY HOURS DURING THE
TWO MANUSCRIPTS.
FIRST AS THE SUB GROUP AND THEN
FULL BOARD.
I WAS OUR ORIGINAL
RECOMMENDATION THE NATURE OF THE
FIND THE HIGHLY PATHOGEN IN H1N1
COULD BE TRANSMISSIBLE IN
ANIMALS AND THE COMMUNICATIONS
NOT BE DISCLOSED AND WE WERE
CONCERNED ON BIOSECURITY
CONCERNS.
THE QUESTION IS COULD SOMEONE
TAKE THE INFORMATION, RECREATE
THE VIRUS AND USE IT FOR HARM.
AND THE NETHERLANDS GOVERNMENT
SAW EXPORT ISSUES IF DANGEROUS
INFORMATION WERE TO BE MADE
PUBLIC.
IT WAS SERIOUS.
IT WAS NO LONGER A QUESTION OF
SCIENTIFIC NORMS BUT POTENTIAL
LEGAL RAMIFICATIONS.
THE AUTHORS WERE ASKED TO
CLARIFY AND PARTLY BECAUSE OF
REMARKS MADE AND DELINEATE THE
BIO SAFETY PRECAUTIONS TO
ALLEVIATE CONCERNS AND BIOSAFETY
AND BIOSECURITY ARE
INTERMINGLED.
WE CONVENED IN PERSON AND WERE
TOLD FRANCIS COLLINS THAT WAS
NOT AN OPTION.
WE WERE GIVEN REVISED
MANUSCRIPTS AFTER SIGNING
CONFIDENTIALITY AGREEMENTS AFTER
CONTROLS AND WERE SENT OFF TO
READ THEM IN WHAT I THOUGHT WAS
A SHORT PERIOD OF TIME AND MAKE
A BINARY DECISION TO PUBLIC OR
NOT.
THERE WAS NO IN BETWEEN THERE.
SO WE ALSO HEARD FROM THE
AUTHORS AND HEARD FROM THE
JOURNALS AND W.H.O. AND OTHER
PUBLIC HEALTH EXPERTS AND
INDIVIDUALS.
ANOTHER KEY CONSIDERATION ON THE
BOARD AT THIS TIME WAS NSTD189.
THE POLICY THAT STATES TO THE
GREATEST EXTENT POLICY THE
RESULTS OF FUNDAMENTAL RESEARCH
SHOULD BE FREELY DISSEMINATED.
AS YOU KNOW, NSABB VOTED AND A
SPLIT VOTE TO PUBLISH THE OTHER
PAPER AND THERE'S FALLOUT THAT
FOLLOWED FROM THERE.
LET ME TURN MY ATTENTION AND ANY
OPINIONS I'M STATING ARE MY OWN
AND DON'T NECESSARILY REPRESENT
THOSE OF THE SOCIETY.
IN RESPONSE TO THE WHOLE H1N1
SITUATION THE ASM TOOK TWO
ACTIONS.
IT SPUN OUT THE RESPONSIBLE
PUBLICATION COMMITTEE.
IT'S COMPRISED OF THE EDITORS
AND CHIEFS OF THREE JOURNALS
JOURNAL OF VIROLOGY AND M SPHERE
AND ONE OTHER THE ONES MOST
LIKELY TO PUBLISH WORK THAT
FALLS UNDER THE RUBRIC OF WHAT
WE'RE CONCERNED WITH AND THE
CHAIR FOR PUBLICATIONS BOARD IS
ON THE COMMITTEE AND IN ANOTHER
VIROLOGIST WHO WAS CHOSEN FROM
THE JOURNAL OF VIROLOGY ENTERS.
THE SOCIETY ALSO ADDED QUESTIONS
TO THE PEER REVIEW FORM ASKING
WHETHER EXPERIMENTS RAISED
BIOSECURITY CONCERNS AND IN THE
CASE OF THE VIROLOGY THE
CATEGORIES WERE ADDED.
FOR REVIEWER OR EDITOR HAS
CONCERNS INITIALLY THE EDITOR
AND CHIEF IS CONSULTED AND THAT
PERSON CAN ASK FOR INPUT FROM
THE COMMITTEE IF THEY DEEM IT
NECESSARY.
IN THE COMMITTEES I'VE BEEN
INVOLVED WITH THE DECISION WAS
ALWAYS MADE TO PUBLIC.
THE PUBLICATION STAGES TOO LATE
AT POINT AT WHICH TO INTERVENE.
THERE'S A COMMON THEME WHEN
THESE STUDIES GET DISCUSSED.
I WANT TO TAKE YOU THROUGH THAT
RIGHT NOW.
SO FIRST IS THAT BY THE TIME WE
SEE IT, THE WORK HAS BEEN PEER
REVIEWED AND THE REVIEWERS HAVE
RECOMMENDED PUBLICATION.
IT INDICATES THEY THINK THE WORK
IS IMPORTANT AND BENEFITS AND
THEREFORE SHOULD BE PUBLISHED.
WHEN THE COMMITTEE DISCUSSES THE
STUDY IT'S DIFFICULT TO MAKE AN
ARGUMENT AGAINST THE BENEFITS OF
THE WORK.
IT'S BEEN REVIEWED BY EXPERTS IN
THE FIELD.
IN ADDITION, THE RPC DOES NOT
HAVE ANY KNOWLEDGE OF WHAT
BIOSECURITY THREATS ARE OUT
THERE.
WE HAVE NO KNOWLEDGE OF WHAT THE
INTELLIGENCE COMMUNITY MIGHT BE
AWARE OF OR THINKING ABOUT.
I WOULD NOTE PARENTHETICALLY,
NSABB WAS BRIEFED IN THE MEETING
WHERE WE DISCUSSED H1N1 AND YET
WE MADE THE DECISION TO PUBLISH.
SO TO THE RPC, THE RISKS ARE
LARGER HYPOTHETICAL AND THINGS
WE CAN DREAM UP.
IN ADDITION, I THINK IT'S BST
PROBABLY SAFE TO NATURE POSES A
LARGER THREAT WHICH MEANS WE
HAVE TO GAIN AS MUCH KEY
KNOWLEDGE AS POSSIBLE ABOUT
THESE PATHOGENS IF WE WANT TO BE
ABLE TO RESPOND TO THE NEXT
OUTBREAK.
WE'RE ASKING TO WEIGH THE RISK
OF A NATURAL THREAT AGAINST THE
BIOTERROR THREAT.
I THINK MARK DENNISON ALLUDED TO
THIS AND THEY CAN BE ENUMERATED
AND LIKELY TO CARRY THE DAY
AGAINST A GROUP OF SCIENTISTS
PARTICULARLY IN THE CASE OF THE
ASM REVIEW.
WE'RE ACTING ON WHAT IS
ESSENTIALLY A BIASSED SET OF
FACTS.
THE OTHER POINT THAT COMES UP
AND KEN BERNARD RAISED THIS IN A
SLIGHTLY DIFFERENT WAY EARLIER
THAT IF WE DECIDE NOT TO
PUBLISH, SOMEONE ELSE WILL OR
SOMEONE WILL POST IT SOMEWHERE.
SO THERE'S ALWAYS THAT TO
CONSIDER.
SO WITH THAT AS BACKGROUND, I'D
LIKE TO POINT OUT A FEW THINGS I
THINK NSABB SHOULD CONSIDER.
AS THIS BOARD HAS DISCUSSED IN
THE PAST AND VARIOUS INDIVIDUALS
INCLUDING MYSELF.
YOU PROBABLY ALL KNOW AND WE
HAVE WRITTEN EXTENSIVELY ON
THIS, OTHERS HAVE ARGUED THIS,
THERE NEEDS TO BE A MUCH MORE
HOLISTIC PROFESSION PROCESS IF
WE THINK A PROJECT MAY POSE
SIGNIFICANT BIOSECURITY RISK.
BEFORE A STUDY COMMENCES, THERE
HAS TO BE CONSENSUS IT'S
ADDRESSING AN IMPORTANT
QUESTION.
WE CAN'T DO EXPERIMENTS JUST
BECAUSE WE THINK THEY'RE COOL OR
EVEN IN SOME INSTANCES SOLELY
BECAUSE THEY SEEM INTERESTING TO
DO.
I THINK IF WE'RE DOING WORK THAT
HAS REAL BIOSECURITY
IMPLICATIONS I THINK IT CAN BE
ARGUED THE WORK OUGHT TO BE HELD
TO A HIGHER STANDARD.
THE PROCESS HAS TO BE
TRANSPARENT AND I WAS PLEASED TO
HEAR THINGS BECAUSE THE NIH HAS
BEEN CRITICIZED RECENT LY FOR TE
WAY IT WAS REVIEWING STUDIES AND
MADE THE ARGUMENT THE TENETS OF
THE GRANT REVIEW PROCESS IN
TERMS OF CONFIDENTIALITY,
ETCETERA, NEED TO BE PROTECTED
BUT AGAIN I'LL MAKE A SIMILAR
ARGUMENT AS I JUST MADE WHICH IS
IF WE'RE CONCERNED ABOUT REAL
BIOSECURITY RISKS THEN THE
NATURE OF THE REVIEW MAY NEED TO
BE DIFFERENT OF A TYPICAL NIH
GRANT OR CONTRACT.
I THINK IF THE PROCESS IS KNOWN
AHEAD OF TIME AND TRANSPARENT
THEN APPLICANTS AND THEIR
INSTITUTIONS CAN DECIDE WHETHER
THEY AGREE TO THE ADDED SCRUTINY
BEFORE APPLYING FOR FUNDING.
I KNOW MARK DENNISON COMMENTED
ON THIS EARLIER ON.
I THINK IT WILL BE AN
INTERESTING DISCUSSION YOU ALL
CAN HAVE.
SO PERHAPS THERE CAN EVEN BE A
PRE-SUBMISSION PROCESS.
AND OF COURSE THERE HAS TO BE
ASSURANCES THAT THE WORK WILL BE
CARRIED OUT SAFELY AND AS
APPROPRIATELY WITH ANY NECESSARY
BIOSECURITY MEASURES IN PLACE.
I THINK DURING THE PROCESS, THE
POSSIBLE RESULTS SHOULD BE
ANTICIPATED AND THERE NEEDS TO
BE A DISCUSSION ABOUT HOW THOSE
RESULTS SHOULD BE DISSEMINATED.
NOW, I WANT TO JUST STATE
UNEQUIVOCALLY, I'M A FAN OF
NSBB189 AND HAVE TO WONDER WHERE
IN TODAY'S WORLD THE ABILITY TO
MANIPULATE ORGANISMS AND
PATHOGENS DOES NOT ALWAYS
REQUIRE SPECIALIZED SKILLS,
KNOWLEDGE OR EQUIPMENT,
SOMETHING BETWEEN OPEN
DISSEMINATION AND CLASSIFICATION
OUGHT TO BE CONSIDERED.
IF THE POSSIBILITY OF RESTRICTED
COMMUNICATION IS KNOWN UP FRONT
AND A CAREFUL AND THOUGHTFUL
DELIBERATION TAKES PLACE PRIOR
TO THE START OF THE STUDY, THERE
SHOULD BE NO MISUNDERSTANDINGS
AND UNDERSTAND NEEDS TO BE
UNDERSTAND IN THE CASE OF
TROUBLESOME FINDINGS WHICH ARE
SOME OF THE MOST EXCITING THINGS
ABOUT RESEARCH.
WE NEED TO KEEP THAT IN MIND.
IN OTHER WORDS, THE PARAMETERS
OF THE WORK NEED TO BE EVALUATED
FROM THE BEGINNING AND ON A
CONTINUING BASIS.
I KNOW THE ARGUMENT IS GOING TO
BE MADE THAT THESE ADDITIONAL
STEPS MAY CAUSE SOME SCIENTISTS
TO DECIDE THEY'RE SIMPLY NOT
GOING TO DO THE WORK AND THAT
WOULD BE A SHAME.
I HOPE THIS IS NOT THE CASE.
I WOULD HOPE THAT IF SCIENTISTS
THINK THAT WHAT THEY'RE
PROPOSING ADDRESSES IMPORTANT
QUESTIONS, THEY CAN CONVINCE
OTHERS THIS IS THE CASE.
THEY CAN REALIZE THERE MAY BE
BIOSECURITY CONCERNS THAT
REQUIRE CONSIDERATION AND THEY
CAN WORK TOGETHER WITH THE
AGENCY TO DEVELOP A LOGICAL PLAN
THAT WILL ENSURE THAT THE
BENEFITS OF THE WORK ARE
MAXIMIZED WHILE MITIGATING THE
RISK AS MUCH AS POSSIBLE AND I
HOPE WE WELCOME THE SCRUTINY
BECAUSE IT SHOWS THE PUBLIC
WE'RE BEING RESPONSIBLE.
IN OTHER WORDS, IF THINGS ARE
IMPORTANT ENOUGH, LET'S MAKE
SURE TO GET IT RIGHT EVEN IF IT
TAKES EXTRA EFFORT.
LET ME FINISH BY SAYING I KNOW
YOU'RE GOING TO ASK, MIKE, HOW
WOULD YOU RESTRICT COMMUNICATION
AND TO BE HONEST I DON'T HAVE A
GOOD ANSWER THOUGH I'VE THOUGHT
ABOUT IT A LOT OVER THE PAST
DECADE BUT IT'S A QUESTION
WORTHY OF CONSIDERATION AND OF
FURTHER DISCUSSION.
SO THANK YOU VERY MUCH.
>> THANK YOU.
THANK YOU FOR YOUR INSIGHTS AND
SHARING YOUR VAST EXPERIENCE AND
THOUGHTFUL INSIGHTS YOU'VE
GAINED OVER A DECADE IN THIS
SPACE.
YOU OFFERED I THINK SOME VERY
IMPORTANT AREAS WE NEED TO
CONSIDER AND WAYS TO THINK ABOUT
THE PROBLEM GOING FORWARD.
YOU HAVE A LOT OF LESSONS
OBSERVED.
MAYBE WE CAN APPLY THEM TO
LESSONS LEARNED AS WE MOVE
FORWARD.
THANK YOU FOR SHARING THOSE
INSIGHT.
I KNOW ALL OF US HAVE QUESTIONS.
WE'LL COME BACK AFTER OUR NEXT
SPEAKER PRESENTS.
OUR NEXT SPEAKER IS DR. RICHARD
SEVER.
ASSISTANT DIRECTOR OF THE COLD
SPRING HARVARD LABORATORY IN NEW
YORK.
AND CO-FUNDER OF THE BIOARCHIVE
AND META-ARCHIVE AND SERVES AS
THE EXECUTIVE EDITOR FOR THE
COLD SPRING HARVARD PROSPECTUS
AND JOURNALS AND LAUNCH
PRECISION MEDICINE JOURNAL AND
MOLECULAR CASE STUDIES.
I THINK WE ALL KNOW HE HAS
WORKED TIRELESSLY TO PROMOTE
SCIENTIFIC COMMUNICATION.
SO RICHARD, THE ZOOM IS NOW
YOURS.
>> CAN EVERYBODY SEE MY SCREEN,
DR. PALKA?
>> YES.
>> MY AFFILIATION IS COLD SPRING
HARVARD LABT RID AND THEY'RE
NON-COMMERCIAL PROJECTS FOR THE
BENEFIT OF THE SCIENTIFIC
COMMUNITY PRIMARILY.
I WANT TO START BY GIVING
BACKGROUND TO THE CONCEPT OF PRE
PRINTS WHICH IS IMPORTANT FORCE
THIS PARTICULAR DISCUSSION.
AND WE ALSO HAVE A HISTORY IN
SCIENTIFIC COMMUNICATION.
WE'RE FAMILIAR WITH THIS, THE
TRADITIONAL PUBLICATION PROCESS.
AND AN AUTHOR SUBMITS TO A
JOURNAL AND THERE'S A PROTRACTED
PROCESS WHERE THE ARTICLE IS
EVALUATED FOR MONTHS AND THIS
CAN GO FOR YEARS BEFORE THE
INFORMATION IN THAT MANUSCRIPT
IS MADE PUBLIC AND ACCESSIBLE TO
THE BROADER SCIENTIFIC
COMMUNITY.
WHAT THE WEB DOES IS AFFORD THE
OPPORTUNITY TO CHANGE THE ORDER
OF THESE EVENTS.
WHAT A PRE PRINT SERVER DOES
SAYS THE AUTHOR CAN MAKE THEIR
FINDINGS IMMEDIATELY WITHIN
HOURS OR DAYS AT MOST BEFORE
THIS EVALUATION PROCESS HAPPENS
WITH A JOURNAL.
IN FACT, IN SOME CASES THE
PROCESS MAY NEVER HAPPEN AND THE
MANUSCRIPT MAY ONLY EVER EXIST
AS AN PREPRINT.
THE FUNDAMENTAL DIFFERENT
THERE'S MANUSCRIPTS IN THE WORLD
THAT HAVE NOT GONE THROUGH THE
FORMAL PEER-REVIEW PROCESS.
THERE'S A NUMBER OF BENEFITS TO
DOING THIS.
AND THERE'S AN OPPORTUNITY FOR
SCIENTIST TO DISCUSS THE WORK
AND HAS VISIBILITY FOR EARLIER
CAREER SCIENTISTS WHO CAN GIVE
EARLY EVIDENCE OF PRODUCTIVITY
AND MAKE THEIR FINDINGS
AVAILABLE TO COMMITTEES LONG
BEFORE THE FORMAL PUBLICATION
APPEARS AND MOST IMPORTANTLY,
WHAT IT DOES IS IT ALLOWS RAPID
TRANSMISSION OF RESULTS SO OTHER
SCIENTISTS CAN IMMEDIATELY BEGIN
BUILDING ON THOSE FINDINGS AND
YOU HOPE FOR GEOMETRIC
PROGRESSION WHERE ULTIMATELY YOU
GET A RAPID INCREASE IN THE PACE
OF THE SCIENCE.
SO WITH THIS IN MIND, THIS IS
SOMETHING THAT HAD BEEN DONE IN
THE COMPUTATIONAL SCIENCE
COMMUNITY SINCE THE EARLY '90s
AND WE LAUNCHED OTHERS TO BRING
THIS APPROACH TO THE BIOMEDICAL
SCIENCES.
IT'S AN IMPORTANT DISTINCTION TO
MAKE IN THE CONTEXT OF
RESPONSIBLE DISSEMINATION THAT
META-ARCHIVE WAS BUILT AS A
SEPARATE SERVER AND OPERATED
ALONGSIDE YALE AND BMJ BECAUSE
WE FELL -- FELT CLINICIANS
NEEDED TO BE INVOLVED AND
CLINICAL FINDINGS AND PATIENT
INFORMATION NEEDED ADDITIONAL
SCREENING AND A HIGHER LEVEL OF
RESPONSIBILITY OF BASIC BIOLOGY.
WE GET AROUND 4,000 SUBMISSIONS
A MONTH, 8 MILLION VIEW THE SITE
EVERY MONTH AND MORE THAN 70% OF
THE PAPERS ARE SUBSEQUENTLY
PUBLISH IN JOURNALS WHICH I
THINK SPEAKS TO THE FACT YOU'RE
LOOKING AT THE SAME INFORMATION
AN JOURNALED AND INTEGRATED SO
THERE CAN BE RAPID TRANSFER OF
MANUSCRIPTS BETWEEN THE TWO.
WE'VE SEEN A LAUNCH OF A NUMBER
OF PREPRINT SERVERS IN OTHER
DISCIPLINES INCLUDING CHEMISTRY,
SOCIAL SCIENCE, PSYCHOLOGY.
I MAKE THIS POINT REALLY JUST TO
INDICATE THAT I THINK THIS
DEMONSTRATES PRE PRINTS PRE-PEER
REVIEW IS BECOMING A NEW NORM
WITHIN THE SCIENTIFIC COMMUNITY.
MANY PEOPLE IN THE MEDICAL
SPHERE BEGAN TO APPRECIATE THIS
MORE THAN EVER DURING THE
PANDEMIC.
BIO ARCHIVE AND META-ARCHIVE WE
POSTED OVER 20,000 COVID PAPERS.
IT STARTED WITH THE ORIGINAL
EPIDEMIOLOGICAL FINDINGS OUT OF
CHINA AND THEN THE EMERGENCE OF
THE CLINICAL TRIAL AND FOR DEX
METH AZONE AND SAW THE
APPEARANCE OF VACCINES IN A
NUMBER OF STUDIES ON HOW
EFFECTIVE THEY'D BEEN AGAINST
THE DIFFERENT VARIANTS.
AND WITH THE PURPOSES OF N
NSABB WE'RE ALSO POSTING
VIROLOGY AND THAT RAISES THE OF
DUAL-USE RESEARCH OF CONCERN AND
PPP ETCETERA.
THE OTHER THING SO MENTION ABOUT
THE PANDEMIC OF COURSE IS THAT
SCIENTISTS LIKE AT THE W.H.O.
AND ANTHONY FAUCI AND OTHERS
CREDITED THE PREPRINT SERVER
DURING THE PANDEMIC AS A WAY OF
RAPID SHARING OF COVID-19
RESEARCH.
AGAIN, I THINK IT ILLUSTRATES
THE FACT THIS IS PART OF THE NEW
NORM AND A PART OF THE
SCIENTIFIC COMMUNICATION PROCESS
NOW AND INDEED THERE'S MANDATES
WHEN A PUBLIC HEALTH EMERGENCY
INFORMATION SHOULD BE SHARED IN
THIS WAY IN THE FORM OF
PREPRINTS.
I WANTED TO GIVE EXAMPLES OF
WHAT WE CONSIDER THE RESPONSIBLE
STEWARDSHIP OF THIS NON-PEER
REVIEWED INFORMATION ON
BIOARCHIVE AND META-ARCHIVE AND
THERE'S A DISCLAIMER IT'S NOT
BEEN PEER-REVIEWED AND AN
EXPLANATION AND AUTHORS MUST
MAKE DECLARATIONS AND COMPETING
INTERESTS AND PARTICIPANT
CONSENT AND CLINICAL TRIALS MUST
BE REGISTERED AND ETHICS MUST BE
THERE FOR CERTAIN TIMES OF
RESEARCH THAT MERITS IRB
OVERSIGHT.
THIS IS ONE OF THE KEY SLIDES
FOR THE PURPOSES OF THIS
AUDIENCE THAT ALL THE PREPRINTS
ARE SCREENED BEFORE THEY GO
LIVE.
WHEN AN AUTHOR SUBMIT AS A
PAPER, SCIENTIFICALLY QUALIFIED
ADMINISTRATIVE STAFF IN-HOUSE
LOOK AT THE PAPER AND A NUMBER
OF PAPERS ARE TURNED AWAY.
IF IT PASS CHECK, IT GOES TO
GROUP OF ACTIVE SCIENTISTS AND
HEALTH PROFESSIONALS WHO LOOK AT
PAPERS AND ABLE TO FLAG PAPERS
THEY FEEL MAY BE SOME CONCERN
ABOUT AND SUCH PAPERS ARE THEN
ESCALATED TO CONSIDERATION BY
THE LEADERSHIP.
IT'S NOT LIKE PUSHING A BUTTON
AND EVERYTHING GOING LIVE.
THESE THINGS ARE SCREENED AND
WE'RE SCREENING FOR PAPERS
NONSENSE OR NON-SCIENCE OR DON'T
APPEAR TO BE RESEARCH.
MAYBE THEY'RE OPINION OR MAY BE
PLAGIARIZED AND WHETHER IT MAY
BE DANGEROUS TO DISSEMINATE THE
MATERIAL.
WHAT WE MEAN BY DANGEROUS IS
ESSENTIALLY WHAT WE CALL OUR
DO-NO-HARM RULES.
PAPERS THAT HAVE THE POTENTIAL
IF ACTED ON BY THE PUBLIC TO
CAUSE HARM IF THEY WERE WRONG,
COULD IT CAUSE HARM?
PAPERS ON VACCINES AND WE TURNED
AWAY A NUMBER OF THOSE TYPES OF
PAPERS, INFECTIOUS DISEASE
TRANSMISSION AND IF A PAPER SAID
HIV IS NOT TRANSMISSIBLE BY
INTERCOURSE WE'LL WE'D TURN AWAY
AND TALKING ABOUT CARCINOGEN TI
OF THINGS LIKE SMOKING WE
WOULDN'T TAKE THOSE AND GAIN OF
FUNCTION AND PPP.
I THINK ONE OF THE INTERESTING
THINGS THAT'S HAPPENED IN THE
COURSE OF THE PANDEMIC ASKING
OURSELVES WHAT IS A PANDEMIC OF
PATHOGENIC POTENTIAL IN THE
MIDDLE OF A PANDEMIC AND WHAT
WOULD SOMEONE HAVE TO DO TO
MERIT THAT GIVEN THERE'S ALREADY
A PANDEMIC?
WE'VE WRITTEN A LITTLE BIT ABOUT
THIS AND I'LL POINT YOU TO THE
ARTICLE IN THE BMJ WHERE WE
TALKED ABOUT THE CHALLENGE WE
FIND HERE.
ANOTHER ASPECT OF RESPONSIBLE
STEWARDSHIP IS THE PAPERS CAN BE
WITHDRAWN OR AUTHORS CAN REQUEST
THE PAPERS WITHDRAWN IF WE HEAR
OF ETHICAL REACHES OR FRAUD THE
PAPER WITHDRAWN AND IT'S AKIN TO
A JOURNAL RETRACTION AND MORE
SEVERE CASE WOULD BE COMPLETE
REMOVAL OF THE ARTICLE WHICH WE
DO FOR COPYRIGHT INFRINGEMENT
AND RISK TO INDIVIDUALS AND
BIOSECURITY WOULD FIT IN THAT
CATEGORY AND WE'VE NOT HAD TO DO
THAT FORTUNATELY.
I HOPE WHAT I'VE SAID SO FAR
INDICATES THE DANGERS OF
DISSEMINATION OF THIS TYPE OF
MATERIAL WE FEEL ARE ADDRESSED
BY SCREENING.
AND THE ERRORS IN INFORMATION
CAN BE ADDRESSED BY COMMENTING
AND WITHDRAWING PAPERS BUT I
WOULD ECHO SOMETHING MIKE JUST
SAID.
THE IMPORTANT POINT HERE IS THAT
EVERYTHING GETS PUBLISHED
SOMEWHERE.
IF IT'S SCREENED AND
META-ARCHIVE OR BIO ARCHIVED
DOES NOT PREVENT THIS BEING ON
THE WEB AND THERE'S REPOSITORIES
THAT HAVE LITTLE TO NO SCREENING
WHATSOEVER AND WE'VE SEEN
MATERIAL THAT IS TURNED AWAY FOR
META-ARCHIVE AND BIO ARCHIVE
APPEAR IN PLACES OFFERING
PLATFORMS LIKE AUTHORIA AND
RESEARCH GATE, LITTLE TO NO
SCREENING OF CONTENT THERE AND
THERE'S LAB WEBSITES AND THE WEB
AS A WHOLE.
I THINK ONE HAS TO BE AWARE
THERE ARE UNVETTED OUTSETS AND
IT'S TOO LATE IN THE GAME TO
EXPECT THE GATE KEEPING TO
HAPPEN HERE.
ALSO, WHEN WE THINK OF THE
JOURNALS AT A SYSTEMIC LEVEL,
THERE'S QUESTIONABLE
EFFECTIVENESS AND THE
HYDROXYCHLOROQUINE STUDIES CAME
OUT AND THE PAPERS SAYING IT
CAME FROM 5G TOWERS OR COMMENTS
FROM ALLEGEDLY PEER-REVIEWED
JOURNALS SO THE ONE THING I'D
QUESTION IS WHEN YOU LOOK AT THE
MORE PREDATORY ACTORS IN THE
SPACE I'M FAR FROM CONVINCED
THEY'D BE ABLE TO IDENTIFY
RESEARCH OF CONCERN LET ALONE
ELIMINATE IT.
I FEEL LIKE I'M ECHOING A LOT OF
THE CONCLUSIONS MIKE DREW.
WE NEED JOINED UP THINKING ON
THIS.
FIRST AND FOREMOST, EDUCATING
RESEARCH IS IMPORTANT.
ONE OF THE THINGS WE NOTICED IN
META-ARCHIVE IS A LOT OF PEOPLE
DURING THE PANDEMIC PIVOTED TO
COVID-19 AND IT WAS NOT ALWAYS
CLEAR THEY WERE AWARE OF THE
RESPONSIBILITIES THEY HAD THERE.
WE POINTED TO SOME AUTHORS OR
META-ARCHIVE WE DIDN'T FEEL WERE
THE APPROPRIATE ETHICAL
OVERSIGHT HAPPENED ON THEIR
PAPERS.
YOU COULD IMAGINE THIS HAPPENING
WITH SOMEBODY WHO PIVOTED TO
WORKING ON COVID-19 AND WAS NOT
AWARE OF THE APPROPRIATE BIO
SAFETY PROCEDURES AS OTHERS HAVE
SAID, WE NEED INTERNATIONAL
GUIDELINES TO GRANT OVERSIGHT
AND ENCOURAGE INSTITUTIONAL
OVERSIGHT.
I THINK ONE COULD THINK ABOUT
HERE IS THE APPROACH OF
PRE-REGISTERING EXPERIMENTS.
THERE ARE SOME FIELDS OF SCIENCE
AND SOCIAL SCIENCE, FOR EXAMPLE,
WHERE PAPERS ARE PUBLISHED
BEFORE THE EXPERIMENTS ARE
CONDUCTED WHICH ESSENTIALLY
OUTLINE EXACTLY WHAT IS GOING TO
BE DONE SO WHEN THE RESEARCH IS
PERFORMED, IT CAN BE COMPARED TO
THE RESEARCH PLAN.
ONE MIGHT THINK ABOUT WHETHER
THAT'S A GOOD IDEA FOR CERTAIN
TYPES OF RESEARCH BECAUSE IT
WOULD ENABLE ESSENTIALLY A
BROADER GROUP OF PEOPLE TO LOOK
AT THE RESEARCH PLAN AND ASSESS
WHETHER OR NOT THAT WORK SHOULD
BE DONE.
FINALLY, GIVEN THE RESEARCH CAN
END UP IN A LOT OF PLACES, A LOT
OF DIFFERENT PLACES, I WOULD
ENCOURAGE FUNDERS TO ENDORSE
RESPONSIBLE OUTLETS FOR RESEARCH
AND META-ARCHIVE AND BIO ARCHIVE
KNOWN TO TAKE THESE THINGS
SERIOUSLY AND THAT WOULD BE A
CARROT FOR AUTHORS TO
ESSENTIALLY BEHAVE WELL IF THEY
GO TO RESPONSIBLE OUTLETS AND
THOSE PERCEIVED AS BEING
RECOGNIZED BY THEIR FOUNDING
BODIES, IS ANOTHER STEP IN THE
CHAIN THAT WOULD ALLOW US TO
MINIMIZE THE LIKELIHOOD THAT
DANGEROUS WORK GETS OUT IN THE
WORLD.
SO THANK YOU VERY MUCH.
THAT'S REALLY ALL I HAVE TO SAY.
>> THANK YOU FOR YOUR COMMENTS.
I THOUGHT ABOUT THE NEED FOR
LOCAL ENHANCED RESPONSIBILITY
AND P.I. ACCOUNTABILITY AND SOME
OF YOUR COMMENTS ALLUDED TO THAT
WOULD BE NECESSARY IN
PRE-THINKING WHAT'S A
RESPONSIBLE WAY TO COMMUNICATE
THE RESULTS AND ANTICIPATED AND
UNANTICIPATED RESULTS.
THAT'S PARTS OF OUR DISCUSSION
AS WE MOVE TO THE NEXT PHASE
WHICH IS OUR DISCUSSION.
SO I INVITE NOW THE MEMBERS OF
THE NSABB TO COME BACK ON AND
THE FLOOR IS OPEN FOR QUESTIONS
FOR OUR TWO PRESENTERS.
I SEE DR. METZGER HAS HIS HANDS
UP FIRST.
>> THANK YOU.
IT SEEMS FROM THE COMMENTS OF
BOTH SPEAKERS MANY OF THESE
ISSUES COULD BE TAKEN CARE OF AT
THE BEGINNING WHEN INVESTIGATORS
ARE THINKING ABOUT WORKING WITH
A PATHOGEN.
I KNOW IF I WANT TO WORK WITH
ANIMALS I HAVE TO GET APPROVAL
BEFORE I CAN EVEN ORDER AN
ANIMAL.
AND WHAT WILL I DO WITH THE
SELECT AGENT.
THE CDC HAS TO APPROVE MY
RESEARCH PLAN.
IT WOULD SEEM IF WE HAD A
SIMILAR REQUIREMENT FOR THE IBC
AND THE INSTITUTION TO REVIEW
WHAT THE INDIVIDUAL WILL BE
DOING WITH A PARTICULAR MICROBE,
THAT MIGHT RESOLVE SOME OF THE
ISSUES WE'RE FACING.
IF THE IBC HAS A CLEARING
UNDERSTANDING OF WHAT THAT ROLE
IS SUPPOSED.
.
I WONDERED IF I CAN GET YOUR
THOUGHTS ABOUT THAT.
AND IF UNEXPECTED RESULTS ARE
OBTAINED WOULD HAVE TO BE
REPORTED TO THE IBC AS IF I WANT
TO INJECT SOME NEW SUBSTANCE
INTO A NEW ANIMAL I HADN'T BEEN
PREVIOUSLY APPROVED FOR I HAVE
TO GET APPROVED FOR THAT AND IF
I MAKE CHANGES IN THE PLAN HAS A
TO GO TO THE IBC FOR APPROVAL.
LIKED TO HEAR THE THOUGHTS OF
THE SPEAKERS.
>> SOMEBODY HAS A HOT MIC.
HELLO, CAN SOMEBODY MUTE?
>> LIKE I WAS SAYING, THE
CONCLUSION WITH HANDING IT OFF
TO THE IBCs IS THERE'S GOING TO
BE A LOT OF INCONSISTENCY AND
MANY IBCs DON'T HAVE THE
REQUIRED PERSONNEL TO MAKE THESE
KINDS OF DECISIONS.
WE'RE HAVING A HARD ENOUGH TIME
AT THE JOURNAL LEVEL WHERE WHERE
WE'RE EXPERTS IN THE FIELD OF
VIROLOGY AND OTHER PATHOGENS.
I THINK THAT'S ONE OF THE
PROBLEMS THERE IS TRYING TO GET
THAT CONSISTENCY.
IF WE THINK ABOUT AN ADDITIONAL
LEVEL OF SCRUTINY, WE HAVE TO
MAKE SURE WE'RE NOT THROWING
HAND IN THE GEARS.
FIRST, DO NO HARM HAS TO BE BE
AN IMPORTANT CONSIDERATION.
>> MY RESPONSE IS THE EXPERTISE
ISN'T AVAILABLE, YOU CONTRACT
OUT WITH EXTERNAL IBC TO GET
THAT EXPERTISE.
I ALSO THINK THERE INTO TO BE
OVERSIGHT AND FOR ANIMALS IT'S
THE OFFICE OF ANIMAL WELFARE.
AS FAR AS PUTTING SAND IN THE
GEARS, I ACTUALLY THINK IT WOULD
SPEED THINGS UP BECAUSE WE HEARD
FROM INVESTIGATORS THAT
SUBMITTED A GRANT AND TOOK A
YEAR TO HEAR BACK THAT GRANT
WASN'T GOING TO GET FUNDED.
THIS WOULD SPEED THE WHOLE
PROCESS UP AND LEAD TO
RECOMMENDATIONS FOR MITIGATION,
FOR EXAMPLE, IF THERE'S
CONCERNS.
I THINK THOSE CONCERNS COULD BE
OVERCOME.
>> ON META-ARCHIVE WE WON'T POST
A PERSPECTIVE INTERVENTION THAT
DOESN'T HAVE A CLINICAL TRIAL
I.D. AND YOU CAN SEE THE
PERPETUATION DOWN THE CHAIN AND
IF YOU DON'T HAVE THAT YOU DON'T
MOVE FURTHER DOWN THE CHAIN
WHICH I THINK MAKES SENSE.
THIS CAME UP IN THE EARLIER
SESSION YOU CAN DO THIS FOR
RESEARCH FROM CERTAIN AREAS BUT
IF YOU'RE A JOURNAL, IF YOU'RE
GETTING NIH-SPONSORED RESEARCH
AND THEN GET IT FROM ANOTHER
COUNTRY YOU DON'T KNOW WHAT
THEIR PROCESS IS LIKE.
DO YOU END UP THROWING SAND IN
THE GEARS OF SOME PEOPLE BUT NOT
OTHERS THROUGH LACK OF
INFORMATION?
BROADLY, I AGREE WITH THAT AS A
STRATEGY.
I THINK THE DEVIL WILL PROBABLY
BE IN THE DETAIL.
>> CAN I ASK HOW MANY
SUBMISSIONS HAVE YOU IDENTIFIED
AS POTENTIAL GAIN OF FUNCTION?
OR P3CO?
>> I WOULD SAY THAT WE'VE
PROBABLY HAD WE MIGHT HAVE HAD
SOMETHING LIKE 20 OR 25 WHERE
THE QUESTION WAS ASKED
INTERNALLY BECAUSE OBVIOUSLY
PARTICULARLY WITH THE COVID
PANDEMIC THERE'S A LOT OF PEOPLE
CERTAINLY DOING -- DOING STUDIES
WITH PSEUDO VIRUS AND LIVE
VIRUS.
IT COMES BACK TO THE QUESTION I
ASKED EARLIER IF IT'S ALREADY A
PANDEMIC THE PATHOGEN'S ALREADY
OUT THERE AND SOMEBODY'S DOING,
FOR EXAMPLE, ANTIBODY CHALLENGES
AND THERE'S NEW VIRUSES
APPEARING IN THE CULTURE, AT
WHAT POINT IF THEY START
SEQUENCING THOSE IS THAT A
BIOSECURITY CHALLENGE?
WE'VE GONE OUT TO PEOPLE SOME
WHO I THINK ARE ON THE CALL IN
THE PAST TO ASK ABOUT THINGS
LIKE THAT BUT FOR THE VAST
MAJORITY OF CASES THE DECISION
WAS IT DIDN'T CONSTITUTE
SOMETHING THAT WAS A RISK.
BUT THERE'S BEEN TWO OR THREE
OCCASIONS WHERE WE TURN PAPERS
AWAY.
I THINK I SHOULD BE CLEAR HERE,
WHEN WE'RE TURNING THEM AWAY
FROM BIOOR META-ARCHIVE WE THINK
THERE'S A POSSIBLE RISK HERE
THAT NEEDS TO BE MORE THOROUGHLY
EVALUATED THAN WE CAN DO AS A
PREPRINT SERVICE AND WE HAVE A
STANDARD PHRASE WE USE "IT'S
BETTER OFF TO PEER REVIEW . "
MY SUSPICION THEY THEN GO TO
JOURNALS LIKE MIKE SPOKE ABOUT
AND THEY GIVE A THOROUGH
ANALYSIS AND DECIDE THE
APPROPRIATE SAFETY PRECAUTIONS
HAVE BEEN MET.
I PERSONALLY HAVE NOT SEEN
ANYTHING TERRIFYING AND WORRIED
ME ABOUT GOING OUT IN THE WORLD
BUT SAW THINGS I THOUGHT NEEDED
AN ADDITIONAL LEVEL OF EXPERT
SCRUTINY THAN WE COULD OR SHOULD
PROVIDE ON A PREPRINT SERVER.
THAT'S FAR FROM UNIQUE TO
RESEARCH OF CONCERN.
THERE ARE AREAS WE HAVE VACCINE
SAFETY ISSUES, VARIOUS THINGS
WITH PATIENTS AND ISSUES WHERE
THERE MAY BE IDENTIFYING
INFORMATION ABOUT A CHILD, FOR
EXAMPLE AND WE SAY WE SIMPLY
CANNOT DO THE APPROPRIATE
SCRUTINY.
THAT'S IN THE VERY SMALL
CATEGORY OF PAPERS THAT SHOULD
GO THROUGH MUCH MORE THOROUGH
PEER-REVIEW AND EDITORIAL
REVIEW.
>> THANKS.
I THINK KIM'S THE NEXT ONE UP.
-- KEN.
>> THIS IS INTERESTING BECAUSE
HANGING AROUND BACK IN THE DAYS
IN 2013, 2014 WITH THE SCIENCE
AND NATURE ARTICLES, BY THE TIME
BY THE TIME THE RESEARCH GETS TO
YOU EVEN AS A PREPRINT IT'S TO
LATE.
IT'S GOING TO GET PUBLISHED.
IT WOULD BE NICE IF IT WENT TO
MICHAEL'S JOURNALS BUT IT WON'T,
IT WILL GET PUBLISHED ONLINE
ANYWAY IF YOU TURN IT AWAY.
THE PROBLEM IS IF WE'RE LOOKING
AT SECURITY BY THE TIME IT GETS
TO A PREPRINT JOURNAL IT'S TOO
LATE.
AND THAT BRINGS ME TO ANOTHER
POINT, THEY'VE BEEN TALKING
ABOUT LOCAL EVALUATION FOR 15
YEARS.
UNFORTUNATELY IT HASN'T BEEN
DEALT WITH FOR 15 YEARS AND
THAT'S WHAT WE NEED TO DO HERE.
THE FIRST SPOT THAT THIS NEEDS
TO BE DEALT WITH IS AT THE LOCAL
IRB OR IBC LEVEL IN SOME FORM.
IF THE EXCUSE THAT WE DON'T HAVE
THE EXPERTISE IS CORRECT AND
THAT IS WHAT NEEDS TO BE FIXED.
WE CAN'T JUST SAY WE HAVE NO
EXPERTISE SO WE'LL JUST LET IT
GO AND LET THE FEDERAL
GOVERNMENT DO IT, WHICH THEY
WON'T DO, BECAUSE IT'S TOO HARD
TO DO THAT MANY EVALUATIONS.
IT WILL HAVE TO BE DONE AT THE
LOCAL LEVEL AND IF THE EXPERTISE
ISN'T THERE IT'S UP TO US TO
RECOMMEND HOW THAT EXPERTISE
SHOULD BE ACCESSED AT THE LOCAL
LEVEL.
EITHER THROUGH LOCAL GROUPS,
REGIONAL GROUPS OR THROUGH A
COMMITTEE -- A LARGER COMMITTEE
OUT OF WASHINGTON.
WE JUST CAN'T KEEP SAYING 10
YEARS FROM NOW, SAY 25 YEARS
AGO, MICHAEL IMPERIALE SAID IT'S
THE SAME DISCUSSION WE'RE HAVING
AND AFRAID IF WE DON'T DEAL WITH
THE LOCAL LEVEL WE'LL END UP
HAVING THE PROBLEM OF
PUBLICATION EITHER IN PREPRINTS
WHICH MAKE IT EASIER NOW OR HAVE
THE PROBLEM OF RESULTS BEING
AVAILABLE TO ANYBODY WHO WANTS
THEM WHETHER OR NOT WE THINK
IT'S A GOOD IDEA.
>> THAT'S TRUE.
I'M VERY INTERESTED TO HEAR FROM
MIKE ABOUT SOMETHING THAT I
ESSENTIALLY I THOUGHT OF LATE IN
THE DAY AND THE NOTION OF
PREREGISTRATION WHICH HAPPENS IN
OTHER FIELDS.
IT HAPPENS IN SOME CLINICAL
FIELD AND I UNDERSTAND THE OPEN
SCIENCE FRAMEWORK ARE BIG ON THE
NOTION OF PRE-REGISTRATION THAT
ALLOWS TO YOU PUBLISH A RESEARCH
PLAN AND THEN OF COURSE THAT
RESEARCH PLAN PUBLIC AND ENABLES
THE POSSIBILITY IF YOU DON'T
HAVE LOCAL EXPERTISE FOR A
BROADER SET OF PEOPLE TO ENGAGE
WITH IT FOR IT TO BE FORMALLY
PEER REVIEWED, ETCETERA.
AS I SAID, IT'S UNUSUAL AND IT'S
UNCOMMON IN BASIC BIOLOGY BUT I
WONDER IF IT'S -- I'M INTERESTED
FROM YOUR PERSPECTIVE, MIKE, AS
AN EDITOR AND RESEARCHER, ONE OF
THOSE THINGS WHERE YOU
FUNDAMENTALLY SAY THIS IS THE
PRICE YOU SAY IF YOU'RE GOING TO
DO THIS TYPE OF RESEARCH IT
NEEDS TO BE PREREGISTERED AND
SAY WE'RE GOING TO DO THESE
THINGS AND TAKE THE INFLUENZA
VIRUS AND SAY THIS IS WHAT WE'RE
GOING TO DO AND GIVES
OPPORTUNITY FOR MORE LOCAL AND
GRANT FUNDERS TO COMMENT ON
WHETHER THIS IS APPROPRIATE
INCLUDING EXPERTS WHO YOU MAY
NOT BE AWARE OF BECAUSE ONE OF
THE CHALLENGES THAT I'VE ASKED
MY COLLEAGUES WHEN WE FIRST
STARTED THINKING ABOUT THIS TYPE
OF RESEARCH IS ALL MY COLLEAGUES
HAVE BEEN INFORMED ABOUT
ESSENTIALLY THE SEVEN DEADLY
SINS TO IDENTIFY THIS TYPE OF
THING BUT ONE OF THE PROBLEMS IS
ALWAYS WHAT IF IT'S A TECHNOLOGY
THAT YOU LOOK AT AND SOMEBODY
WHO'S NOT SUFFICIENTLY EXPERT
AND DOESN'T THINK IT'S A CONCERN
BUT CAN BE USED IN A WAY THAT'S
CONCERNING.
IF SOMEBODY CREATED A NEW FORM
OF DNA SYNTHESIS THAT WORKED
WELL COUPLED WITH VIRAL
DELIVERY, SUDDENLY, YOU HAVE TO
BE ABLE TO LOOK AT THIS COULD
EASILY ALLOW SOMEBODY TO
REPLICATE SMALLPOX OR WHATEVER.
I'M INTERESTED IN WHAT MIKE
THINKS ABOUT THAT NOTION?
>> I'M GLAD YOU BROUGHT THAT UP.
I'VE KNOWN ABOUT THESE TYPES OF
PUBLICATIONS BUT MOSTLY IN THE
CONTEXT OF CLINICAL TRIALS.
THE PROPOSED TRIAL BEING PUT OUT
THERE AND THERE'S THE INTENT TO
MAKE SURE WHEN THEY DID THE
TRIAL THEY DID WHAT THEY SAID
THEY WERE GOING DO.
I HADN'T THOUGHT ABOUT IT A LOT
IN THIS CONTEXT.
MY GUT FEELING IS THAT SO YOU
PUBLISH A PRE-PLAN AND MAYBE YOU
GET FEEDBACK AND THEN WHAT?
RIGHT?
I GUESS THAT WOULD HAVE TO BE
WORKED OUT SOMEHOW.
I HAVEN'T THOUGHT ABOUT IT WITH
RESPECT TO THE ISSUE AT HAND
RIGHT HERE.
MARK.
>> GREETINGS.
I HAD A THEORETICAL THING.
SO YOU LIKELY IN NEXT COUPLE
YEARS WILL BE SEEING A LOT OF
PUBLICATIONS COMING IN FROM
POTENTIAL ANTIVIRALS FOR
MULTIPLE PANDEMIC PATHOGENS
BECAUSE OF THE NIH FUNDING AND
PROBABLY 60 OR 70 INSTITUTIONS
AND MULTIPLE COMPANIES FOR
INTERNATIONAL COLLABORATIONS
CORE STRUCTURES, METHODOLOGIES,
ETCETERA WILL BE COMING YOUR
WAY.
AND DISCLAIMER, I'M IN ONE OF
THESE SO IT'S RELEVANT TO ME AND
THERE'S THE ISSUE OF COUNTER
MEASURES SPECIFICALLY.
IN TERMS OF THE PROPOSAL IT'S
REQUIRED FOR A MECHANISM OF
ACTION AND THAT ACTION REQUIRES
LOTS OF TIME AND MAYBE UNKNOWN
IF IT'S A NEW COMPOUND.
THAT WOULD MEAN PASSAGE AND THAT
WOULD MINE IDENTIFICATION OF
VARIANTS THAT MIGHT ESCAPE.
IN ORDER TO BE ABLE TO
UNDERSTAND THE TARGET THERE'S A
LOT OF PUBLICATIONS COMING OUT
NOW LOOKING AT VARIANTS IN
PATIENTS THAT ARE UNDER
INVESTIGATION.
THEY'RE CONFIRMING A LOT OF IN
VITRO THINGS THAT WERE
PREVIOUSLY STUDIED.
SO HOW ARE YOU ASSESSING AND
WHAT DO YOU DO?
THESE ARE OUR APPROVED GRANTS
GOING FORWARD.
HOW DO YOU ASSESS WHEN A
MUTATION IN A POLYMERASE OR
PROTEASE, CAN YOU ASSESS RISK
AND BENEFIT AND DO YOU LOOK AT
IT AT ALL IN THAT STAGE OR FEEL
THAT'S ALREADY BEEN DETERMINED
AT THIS POINT?
>> ARE YOU ASKING A QUESTION?
>> THAT WAS A QUESTION.
IS THIS --
>> I DON'T KNOW.
>> ARE THERE MUTATIONS
ASSOCIATED WITH MECHANISM AND
HOW THE VIRUS MIGHT ESCAPE FROM
THE COMPOUNDS TO INFORM
SURVEILLANCE?
>> WE'RE DEALING WITH THOSE
KINDS OF THINGS ALREADY WITH
RESPECT TO PATHOGENS.
LOOK AT THE ANTIBIOTIC-RESISTANT
BACTERIA.
SOCIETY HAS BEEN DOING THE
EXPERIMENT FOR YEARS AND YEARS.
OBVIOUSLY THE SCIENCE WILL HAVE
TO KEEP UP AND WE HAVE TO MOVE
THE SCIENCE FORWARD.
I THINK IT'S CAREFUL.
I THINK YOU CAN'T STOP DOING
THOSE EXPERIMENTS JUST BECAUSE
YOU MIGHT GET A RESISTANT
VARIANT COMING UP.
YOU HAVE TO LEARN MORE ABOUT THE
RESISTANCE AND TRY TO NOW FIGURE
OUT A WAY AND HOW DO YOU FIGHT
THAT BATTLE AT THE NEXT LEVEL.
BUT THESE THINGS HAVE TO BE
DISCUSSED IS THE POINT I'M
TRYING TO MAKE HERE.
>> WHAT IT SOUNDS LIKE, WE'VE
SEEN PAPERS USING CONVALESCENCE
FLUIDS AND LOOK AT IS THIS
SOMETHING WE SHOULD WORRY ABOUT
AND AGAIN IT SPEAKS TO, IS YOUR
DECISION DIFFERENT IN THE MIDST
OF A PANDEMIC WHERE YOU ACTUALLY
KNOW THE WORRY ABOUT PRODUCING
MUTATIONS BECAUSE YOUR PASSING
SOMETHING IN CULTURE WHEN HAVE
YOU BILLIONS OF PEOPLE WHERE THE
VIRUS IS GENERATING NEW
MUTATIONS ALL THE TIME PUTS IT
IN PERSPECTIVE BUT MAYBE YOU
WOULD MAKE DIFFERENT DECISIONS
IF IT WERE A VIRUS THAT WERE NOT
IN A BILLION PEOPLE.
>> THE OTHER POINT I'LL MAKE IS
WOULDN'T IT BE BETTER IF AN
ISSUE DOES COME UP THAT WE CAN
SAY, LOOK, THESE EXPERIMENTS
WERE VETTED BY A GROUP OF
EXPERTS AND TAKING IN WHATEVER
STAKEHOLDER WIDE GROUP YOU WANT
TO IDENTIFY.
THAT'S SOMETHING THE BOARD'S
GOING TO HAVE TO THINK ABOUT.
WOULDN'T IT BE BETTER TO SAY,
YEAH, WE THOUGHT ABOUT THESE
THINGS?
WE AS A GROUP DETERMINED THIS
WAS WORTHWHILE PURSUING OPPOSED
TO SOMETHING BAD HAPPENS AND
IT'S LIKE, OH, MAN, THESE CRAZY
SCIENTISTS.
THEY CAN'T BE TRUSTED.
>> IT MAY BRING UP THE
POSSIBILITY OF A MULTI-CENTER
GRANT AND MULTI-CENTER REVIEW
LOOKING AT INDIVIDUAL
EXPERIMENTS AND HAVE YOU THE
REQUIRED EXPERTISE FOR THAT KIND
OF ONGOING REVIEW IF IT'S A
LARGE MULTI-CENTERED PROGRAM.
>> ALEX AND THEN DENNIS.
>> THANK YOU.
I THINK MY QUESTION IS FOR
DR. IMPERIALE.
SO YOU SAID RIGHTLY, I THINK,
THERE ARE RISKS NOT ENOUGH TO
COUNTER THE THREATS OF NATURE
AND THEY HAVE TO BE BALANCED
AGAINST THE RISK OF WE TRY TO DO
AGAINST THE RISK AND IT'S
IMPORTANT WE HAVE CONSENSUS AND
THE KINDS OF CATEGORIES OF
RESEARCH WE'RE TALKING ABOUT HAS
REAL VALUE.
I AGREE WITH THAT ALSO BECAUSE
WITHOUT REAL VALUE THE ETHICAL
JUSTIFICATION DOESN'T EXIST.
MY QUESTION IS WHAT IS THE
MECHANISM THAT WE OUGHT TO USE
TO MAKE SURE -- BECAUSE YOU ALSO
SAID SOMETHING ABOUT THERE NEEDS
TO BE CONSENSUS ABOUT VALUE
QUESTION.
IN SOME AREAS THERE'S REAL DE
CENSUS ABOUT THE METH ON THE AND
THE RISK THEY GENERATE AND
WHETHER THEY'RE NECESSARY OR
WHETHER THE SAME INFORMATION
COULD BE USED WITH LOWER RISK
METHODS.
IS THAT A QUESTION THAT OUGHT TO
BE AT THE LOCAL LEVEL OR DEALT
WITH AT THE DISCIPLINARY LEVEL?
SHOULD THAT BE BEFORE A LARGER
INTERDISCIPLINARY GROUP?
I'D LIKE TO HEAR YOUR THOUGHTS.
>> GREAT QUESTION.
THERE'S A FEW DIFFERENT POINTS.
FIRST, AS YOU MAY GUESS FROM MY
EARLIER RESPONSE TO DENNIS A
QUESTION, I'M NOT SURE THE LOCAL
LEVEL IS REALLY GOING TO BE ABLE
TO PLAY THAT ROLE, AGAIN, I
THINK THERE'S GOING TO BE
INCONS
INCONSIST -- INCONSISTENCY AND
WITH THESE TYPES OF EXPERIMENTS
IT'S MORE OF A CONTINUUM.
THERE'S GOING TO BE A LITTLE BIT
MORE VARIABILITY THERE AND ON
TOP OF THAT, I THINK YOU'RE
GOING TO GET INTO A SITUATION
WHERE THE RISK TOLL LANCE RANS
OF THE DIFFERENT -- TOLERANCE OF
THE DIFFERENT INSTITUTIONS WILL
FEED IN THE DISCUSSION AND THAT
WILL HAVE TO BE DEALT WITH.
I'VE GOT CONCERNS ABOUT BEING AT
THE LOCAL LEVEL BUT I UNDERSTAND
WHAT KEN IS SAYING.
THIS IS SOMETHING WE HAVE TO
COME TO GRIPS WITH IN ONE WAY OR
ANOTHER.
I THINK THAT'S SOMETHING YOU
SHOULD CONTINUE TO DISCUSS.
IN TERMS OF WHO NEEDS TO BE
INVOLVED IN THESE DISCUSSIONS,
IF WE'RE GOING TO TALK ABOUT NOT
DOING AN EXPERIMENT, I THINK WE
HAVE TO MAKE IT CLEAR, WHAT IS
OUR CONCERN IN MY VIEW, FOR
EXAMPLE, IF THE CONCERN IS A BIO
SAFETY CONCERN, THEN LET'S FINDS
A WAY TO DO THE EXPERIMENT
SAFELY IF WE THINK THEY'RE
IMPORTANT ENOUGH TO DO.
IF IT'S A BIO SECURITY CONCERN
AND WE THINK IT'S IMPORTANT TO
DO AND WE'RE CONVINCED THE
BENEFIT WILL OUGHT -- OUTWEIGH
THE RISK LET'S LOOK AT WHATEVER
BIOSECURITY PARAMETERS ARE IN
PLACE TO MAKE SURE THINGS ARE
SECURE AND THAT'S WHERE NOW YOU
HAVE TO THINK ABOUT INFORMATION
SECURITY TOO.
I DON'T KNOW DO UNIVERSITIES
HAVE BIOSECURITY CONCERNS AND IS
VANDY PROTECTED AND THERE'S
ALWAYS GOING TO BE SOME LEVEL OF
RISK WE AS SOCIETY WILL HAVE TO
BE WILLING TO ACCEPT IF WE WANT
TO GET THE BENEFITS OUT OF WHAT
WE'RE DOING.
WE HAVE TO ENSURE THOSE INVOLVED
IN THE DISCUSSIONS IN MY VIEW
ARE REPRESENTING THE VIEW POINTS
OF SOCIETY AS A WHOLE AND HAS
BECOME ALL THE MORE DIFFICULT IN
RECENT YEARS BECAUSE OF THE
POLITICIZATION OF EVERYTHING AND
I DON'T HAVE A GOOD ANSWER.
WE CAN'T DO NOTHING JUST BECAUSE
WE DON'T HAVE THE PERFECT
ANSWER.
AND SOMEBODY MENTIONED IF WE
COME BACK AND EVALUATE ON OUR
PERIODIC BASIS, ARE THESE THINGS
WORKS?
WITH ALL DUE RESPECT TO MY
COLLEAGUES AT THE NIH AFTER THE
H1N1 WE SAID WE HAVE TO
RE-EVALUATE OUR FRAMEWORK AND
WHAT WE'RE DOING AND DIDN'T GET
DONE UNTIL MANY YEARS LATER.
WE HAVE TO HAVE AN ONGOING
DISCUSSION.
>> THANKS, MICHAEL.
WE ALSO HEAR YOU ABOUT -- AND WE
GRAPPLE WITH ENHANCING LOCAL
RESPONSIBILITY AND
ACCOUNTABILITY.
IT'S NOT THERE TODAY BUT COULD
BE AND NEEDS TO BE.
HOW DO WE GO FROM TOP-DOWN
OVERSIGHT AND ENHANCE LOCAL
RESPONSIBILITY?
THAT'S THE ISSUE.
WE CAN'T DO NOTHING AS YOU SAID,
WE HAVE TO DO SOMETHING.
>> MAYBE THE BIO SAFETY LABS CAN
BE INVOLVED.
THEY'RE ALREADY GIVEN
SUBSTANTIAL AMOUNTS OF SUPPORT
FROM THE GOVERNMENT AND SHOULD
BE TASKED WITH THESE REVIEWS AND
CURIOUS OF YOUR THOUGHTS,
MICHAEL.
>> I DON'T REMEMBER THE DETAILS
OF THE DISCUSSION.
>> THERE ARE A LOT OF AREAS AND
MICHAEL KNOWS WHERE JOURNALS
COLLABORATE ON POLICIES AND
PROCEDURES AND HAVING A WAY
WHERE JOURNALS CAN SIGN ON TO
PROCESSES BY WHICH WHAT THEY
EXPECT WHEN THEY GET CERTAIN
TYPES OF RESEARCH AND JOURNALS
ROUTINELY DO THIS WITH CERTAIN
TYPES OF INFORMATION.
FOR EXAMPLE, IDENTIFICATION OF
RESEARCH PARTICIPANTS.
THERE'S CERTAIN THINGS YOU DO TO
MINIMIZE THE LIKELIHOOD A
PATIENT COULD BE IDENTIFIED FOR
A RESEARCH PAPER AND GOOD
JOURNALS WILL SIGN UP FOR BEST
PRACTICES.
IT'S CRITICAL TO HAVE JOURNALS
BE AWARE OF THAT AND AT THE
LOCAL LEVEL HAVE INSTITUTIONS
AND RESEARCHERS BE AAWARE OF --
AWARE OF THINGS AND WHEN
SOMEBODY SENDS IN A PAPER WE SAY
THERE'S WAYS PEOPLE COULD BE
IDENTIFIED IN THE PAPER AND YOU
NEED TO CHANGE IT AND THEY SAY,
OH, GOD, THAT'S TOO MUCH HASSLE
FOR ME AND I WON'T SUBMIT TO YOU
AGAIN.
THAT'S NOT THE WAY IT SHOULD
OPERATE AND SHOULD BE AN
UNDERSTANDING WHEN THEY DID THE
RESEARCH AND FROM THE
INSTITUTIONAL LEVEL OVERSIGHT
THIS IS HOW IT SHOULD BE DONE SO
WHEN THEY COME TO THE
DISSEMINATION VENUE, A, THAT
DOESN'T HAPPEN BECAUSE THEY'VE
ALREADY GOT IT OR IF THEY'RE
FACED WITH IT THEY SAY I DIDN'T
REALIZE I SHOULD HAVE DONE IT.
>> IT'S 3:42, EASTERN TIME.
I SEE RENE HAS JOINED US AND I
KNOW SHE HAS A TIGHT TIME
SCHEDULE AND DON'T SEE ANY OTHER
HANDS SO WE'RE GOING TO MOVE TO
OUR FINAL SESSION.
SO THE FINAL SESSION I'M PLEASED
TO WELCOME -- FIRST, LET ME
THANK RICHARD AND MICHAEL FOR
SHARING THEIR EXPERIENCES AND
THOUGHTS ON THIS AND I'M SURE
WE'RE GOING TO BE REACHING BACK
OUT WITH MORE AS WE CONTINUE OUR
DELIBERATION.
THANK YOU IN ADVANCE AS WE
POSSIBLY WILL REACH BACK OUT TO
YOU AND REVIEW THE DURC POLICIES
FROM A DECADE AGO, MICHAEL.
I INVITE OUR NEXT THREE SPEAKERS
WHO ARE GOING TO COVER ISSUES
RELATED TO GOVERNANCE OPTIONS
FOR OVERSIGHT OF RESEARCH
INCLUDING P3CO AND DURNG.
THE GOALS ARE IDENTIFIED
POTENTIAL STRENGTHS AND
WEAKNESSES OF A P3CO FRAMEWORK
AND DISCUSSAL ALTERNATE
APPROACHES AND CONSIDER PROS AND
CONS OF OVERSIGHT FRAME WORKS.
I'LL INTRODUCE EACH SPEAKER ASK
THEM TO DO THEIR REMARKS.
THE FIRST WE'RE HONORED TO HAVE
THE VICE PRESIDENT OF GINKO BIO
WORKS AND HEAD OF INNOVATION AT
CONCENTRIC GINKO WHERE SHE IS
CURRENTLY APPLYING SYNTHETIC
BIOLOGY TO OUTPACE INFECTIOUS
DISEASES INCLUDING COVID-19
THROUGH BIO SURVEILLANCE.
PRIOR SHE WAS A PROGRAM MANAGER
AT DARPA AND LEVERAGED GENE
EDITING AND SYNTHETIC EDITING
AND THWARTED BIO THREATS AND HAD
AN EXTENSIVE PORTFOLIO.
SHE SERVES ON THE NATIONAL
ACADEMY OF SCIENCE AND MEDICINE
FOR NATIONAL SECURITY AND
SCIENTIFIC ADVISORY BOARDS FOR
REVIEW AND AMP AND THE
INNOVATION GENOMICS INSTITUTE.
RENE, THE ZOOM FLOOR IS YOURS.
>> I'M EXCITED TO BE HERE
REPRESENTING GINKO AND SOME
INDUSTRY PERSPECTIVES AND ID
LEANS BACK TO MY TIME AS WORKING
ON BIOSECURITY.
I HAVE A FEW REMARKS I'D LIKE TO
SHARE.
THERE WERE THREE QUESTIONS
PROVIDED TO ME IN ADVANCE SO I
FRAME MY RESPONSES IN THE
CONTEXT OF THE QUESTIONS AND
COMMENTS.
THE FIRST IDENTIFY POTENTIAL
STRENGTHS AND WEAKNESSES OF AN
INTEGRATED P3CO OVERSIGHT
FRAMEWORK.
THE WAY I THINK ABOUT THE
FRAMEWORK, I'LL GET INTO
SPECIFIC EXAMPLES BUT I THINK
THE PERSPECTIVE I BRING IS WE'RE
USHERING THE CENTURY OF
ENGINEERED BIOLOGY WHETHER
BIOLOGY OR MEDICINES IN OUR GUT
OR IN SOIL TO PROMOTE
FERTILIZATION AND GROWTH AS WE
FACE CHALLENGES LIKE CLIMATE
CHANGE.
IF WE'RE USHERING THAT CENTURY
OF ENGINEERED BIOLOGY THESE
FRAME WORKS WILL BECOME OBSOLETE
IF WE AREN'T CREATING THE
DEFINITIONS AND GOVERNANCE
AROUND THESE EMERGENT POTENTIAL
AND DUAL USE.
FOLKS ON THE ZOOM CALL HAVE DEEP
EXPERTISE BUT NOT EVERYBODY
KNOWS WHAT TO LOOK OUT FOR AND
MAKING SURE ANY GUIDANCE IS
PRESSURE TESTED AND DONE SO AND
A REGULAR BASIS BECAUSE WE MAY
SURPRISE OURSELVES OF THINGS
THAT WE DIDN'T IMAGINE THAT
ENGINEERED BIOLOGIES WILL CAUSE
DUAL-USE RESEARCH CHALLENGES.
IN MANY CASES I THINK THE
ADVANCES CAN BE LEVERAGED TO
PRODUCE RISK AND DO THE ANALYSIS
OF ALTERNATIVES AND USE
TECHNOLOGY ITSELF AND I'LL GIVE
EXAMPLES OF WAYS I THINK WE CAN
START TO LEAN INTO THE FRAMEWORK
AND BRING THESE TECHNOLOGIES TO
LIFE.
SO DISCUSSING ALTERNATIVE
GOVERNANCE APPROACHES TO
MANAGING RESEARCH THAT POSES A
THREAT.
THERE'S GOING TO BE A FEW
SPECIFIC EXAMPLES.
ONE IS THIS ANALYSIS OF
ALTERNATIVES.
THE P3CO GUIDANCE PART I THINK
IS UNDER UTILIZED TODAY IS
LOOKING AT IS THERE A FEASIBLE,
EQUALLY EFFECTIVE ALTERNATIVE
METHOD TO ADDRESS THE SAME
QUESTION?
IT'S EASY TO THINK ABOUT AN
EXPERIMENT THAT COULD BE GAIN OF
FUNCTION FOR EXAMPLE AND SAY IT
WILL BE HARD TO RECREATE THAT.
THAT'S WITHOUT DOING THAT
EXPERIMENT.
I WOULD CHALLENGE THAT STATEMENT
AND IF YOU LOOK AT WHAT THE GAIN
OF FUNCTIONS ARE INTENDED TO DO
AND WHAT ANSWERS ARE THEY MEANT
TO ANSWER ABOUT THE PHYSIOLOGY
AND GENICITY AND THINGS LIKE
COMBINING AND ANTIBIOTIC
RESISTANCE AND WE'RE GOING DOWN
WITH FOUNDRY, HIGH-THROUGHPUT
AUTOMATED WORK FLOWS MANY OF
THESE QUESTIONS CAN BE ANSWERED
USING THE TOOLS OF SYNTHETIC
BIOLOGY AND HERE AT GINKO, WE
CAN RUN MORE THAN 1 MILLION
TESTS A DAY AND IN THE A NEW
VARIANT IS SOMETHING WE SHOULD
BE WORRIED ABOUT AND WE COULD
MAKE THE SPIKE PROTEINS AND RUN
THEM AGAINST ANTIBODIES OR
RECEPTOR BINDING AND LEARN
SOMETHING ABOUT THE TOOLS
WITHOUT DOING THE EXPERIMENT
ITSELF.
USING THE TOOLS TO DO THAT
EXPERIMENT AND ANSWER THE
QUESTIONS AND REDUCE THE RISK IN
MANY CASES FASTER THAN
TRADITIONAL APPROACHES WHERE YOU
MAY HAVE TO LEARN HOW TO CULTURE
ONE OF THOSE VIRUSES, FOR
EXAMPLE, IS AN UNDER UTILIZED
TOOL AND I MAKE A RECOMMENDATION
WHERE HOW CAN WE MAKE
SUGGESTIONS HOW TO IMPLEMENT
THAT GUIDANCE IN A BETTER WAY OF
LOOKING EVEN BEYOND WHERE AN
EXPERIMENT MAY BE DONE IN ONE
GIVEN AGENCY.
LOOK TO EXPERTS IN OTHER
GOVERNMENT ORGANIZATIONS BUT
ALSO TO INDUSTRY WHERE WE'RE
JUST AS WORRIED ABOUT
BIOSECURITY ON THE INDUSTRY SIDE
AND WANT HELP WITH THOSE
SOLUTIONS.
ANOTHER EXAMPLE AND THIS IS
DURING MY TIME AT DARPA THERE
WAS A PROGRAM THAT I WAS
DEVELOPING AND THE PURPOSE WAS
TO ENABLE GENE-EDITING
TECHNOLOGIES AND TO DO SO IN A
WAY WHERE THEY ARE SAFER AND
HAVE LESS OFF-TARGET AFFECTS AND
WE'RE ABLE TO DEVELOP COUNTER
MEASURES AND EVEN REVERSE THEIR
EFFECT.
WHEN PUTTING FORWARD THE FUNDING
ANNOUNCEMENT, WHAT WAS CLEAR IS
THAT THERE WERE NOT REGULATIONS
THAT WERE IN PLACE THAT YOU
COULD CLEARLY POINT OUT BESIDES
THE STANDARD BSL GUIDANCE AND
INSTITUTIONAL REVIEW TO DO THIS
WORK IN A WAY THAT WE FELT
COMFORTABLE.
ONE EXAMPLE WOULD BE WE
ANTICIPATED WE WOULD GET
PROPOSALS THAT LOOKED AT GENE
DRIVE TECHNOLOGIES WHERE YOU
COULD ALSO AS A FUNDER IMPLEMENT
GOVERNANCE WHERE WE COULD SAY,
OKAY, IF YOU'RE GOING TO WORK ON
A MOSQUITO, MAKE SURE YOU ONLY
DO THAT WORK IN A REGION WHERE
THE MOSQUITO IS NOT NATIVE SO IF
THERE'S AN ACCIDENTAL MISTAKE IT
WON'T PROPAGATE.
MAKE SURE THERE'S MOLECULAR
CONTAINMENT MEANING BEYOND THE
CAGES AND LABS THAT WOULD BE
PHYSICAL AND MOLECULAR
CONTAINMENT COULD BE A KILL
SWITCH OR COMPONENTS AND THERE'S
A MASSIVE LEVER TO PUT IN PLACE
AND WE BROUGHT IN EXTERNAL
ADVISORS TO COME AND LOOK AT THE
TEAMS AND WORK THEY WERE DOING
AND IN A ROUTINE BASIS NOT JUST
AT THE POINT OF STARTING THE
PROGRAM, KEEP REVIEWING THE
GUIDANCE AND SEE IMPROVEMENTS WE
CAN MAKE.
I THINK THIS IS SOMETHING NOT
MANDATED ACROSS MANY FUNDING
AGENCIES AND WOULD BE AN
IMPORTANT THING TO CONSIDER.
AND THEN IF I PUT MY DARPA HAT
ON THINKING OF OTHER UNIQUE WAYS
TO THINK ABOUT IMPLEMENTING
GOVERNANCE.
ONE OF MY COLLEAGUES ON THE CALL
MENTIONED S.
AND THE EXPERIMENTS HAVE BEEN
CONDUCTED AND EVEN THINKING
ABOUT THAT LEVEL OF REVIEW, IF
THERE'S NOT SOMETHING WITH A
BIOSECURITY BACKGROUND A
REVIEWER MAY NOT SEE THE
CHALLENGE AND THERE'S A SMALL
ENOUGH COMMUNITY THAT WORKS ON
BIOSECURITY WHERE WE CAN START
TO WORK WITH THE NATURE
PROCESSING SIDE OF THINGS AND
GENERATE PROGRAMS THAT CAN SCAN
THINGS LIKE BIO ARCHIVE OR BE
EMBEDDED IN A JOURNAL TO LOOK
FOR KEY TERMS THAT MAY BE
CONCERNS AND TRAIN THOSE
ALGORITHMS TO BE ABLE TO FLAG
SOME OF THIS RESEARCH BEFORE
IT'S CONDUCTED.
SO WHEN IT'S IN THE PROTOCOL
PHASE OR UP TO THE POINT OF
REPRODUCTION AND I'VE BEEN ASKED
TO LOOK AT RISK-BASED OVERSIGHT
FRAME WORKS.
LOOKING AT THE SPACE AND A
WASN'T HERE FOR THE WHOLE CALL
BUT I'M SURE FOLKS CAN DEGREE IT
CAN BE OBSOLETE QUICKLY.
WHAT ARE RESPONSIBLE
ALTERNATIVES TO LIKE A LIST
SERVE METHOD AND MAYBE SOME OF
THE RESEARCH IS IMPORTANT TO DO
AND AGAIN HOW DO WE ANSWER SOME
OF THOSE QUESTIONS WITHOUT
ACTUALLY DOING THE WORK.
THERE'S A REAL OPPORTUNITY HERE
ON THE HEELS OF A PANDEMIC WHERE
WE CREATED AN INFRASTRUCTURE AND
BROUGHT TOGETHER SO MANY LABS
AND CAPABILITIES EVEN WASTE
WATER TESTING IS BECOMING MORE
AND MORE STANDARD.
SUSTAINING THIS TYPE OF
SURVEILLANCE THAT CAN BE IN
PLACE TO PROVIDE EARLY WARNING
WILL BE IMPORTANT TO MAINTAIN
AND IN BETWEEN PANIC AND NEGLECT
CYCLES THAT ARE TYPICAL FOR
PANDEMICS AND FUNDING CANDIDLY.
I THINK ONE EXAMPLE OF WHY YOU
WANT THIS IN PLACE, MASSIVE
MONITORING AND AIR MONITORING
AND WASTE WATER, IF YOU LOOK AT
OMICRON IT WAS CALLED THE
VARIANT OF CONCERN AND
THANKSGIVING WEEKEND IT WAS FOUR
WEEKS BEFORE MORE THAN 90% OF
THE POPULATION HAD THE STRAINS
MEASURED WERE OMICRON.
ABLE TO OUTCOMPETE WHAT WAS
THERE IS PHENOMENAL.
IF YOU DON'T HAVE THAT SYSTEM IN
PLACE, FORGET IT, YOU WON'T BE
ABLE TO PICK IT UP.
HOW DO WE LOOK FOR ENGINEERI IN
SOMETHING INDICATIVE THAT IS
LIKE A CAPTURED RELEASE OR AN
ENGINEERED THREAT.
WE DON'T HAVE THAT YET AND THAT
CAPABILITY WON'T HAPPEN
OVERNIGHT.
WE'LL NEED CARE AND FEEDING TO
PROVIDE MUSCLE AND.
ONE EXAMPLE I'LL ARPA-H HAS A
METHOD TO LOOK AT SEQUENCES AND
SAY, IS THIS ENGINEERED?
HOW CAN WE START TO UNDERSTAND
THE INTENT OF THE SEQUENCE.
I WANT TO MAKE SURE MY OTHER
COLLEAGUES HAVE A CHANCE TO JUMP
IN BUT I APPRECIATE THE
OPPORTUNITY AND LOOK FORWARD TO
QUESTIONS THAT COME PART OF THE
SESSION.
THANK YOU.
>> THANK YOU FOR TAKING THE TIME
TO BE WITH US.
I'M NOT SURE HOW LONG YOU CAN
STAY ON BUT HOPEFULLY A LITTLE
BIT TO GET QUESTIONS IN.
>> I SHOULD BE HERE FOR THE
WHOLE SESSION.
>> THANK YOU.
OUR NEXT SPEAKER IS DIRECTOR OF
THE CENTER FOR COMMUNICABLE
DISEASES DYNAMICS AT HARVARD PH
KHAN SCHOOL OF PUBLIC HEALTH.
HIS RESEARCH CONCERNS
EPIDEMIOLOGY AND INFECTIOUS
AGENTS AND DECISION MAKING.
SINCE 2001 HE'S BEEN ON LOAN TO
THE CDC AS A FOUNDING DIRECTOR
FOR SCIENCE AS THE CENTER FOR
FORECASTING AND OUTBREAK
ANALYTICS.
THOUGH HE SPEAKS PURELY IN HIS
ACADE
ACADEMIC CAPACITY AND HIS
STATEMENTS DON'T REVIEW ANY
GOVERNMENT AGENCY.
HE'S THE AUTHOR OF OVER 400
PEER-REVIEWED PAPERS AND PART OF
THE NATIONAL ACADEMY OF
MEDICINE.
MARC, IT'S ALL YOURS.
>> THANK YOU FOR THE OPPORTUNITY
TO BE HERE ON THIS DISTINGUISHED
PANEL AND FOR THE OPPORTUNITY TO
SPEAK.
I'VE ONLY BEEN AT CDC SINCE
2021.
SORRY IF I PUT A TYPO IN MY
NOTES.
GOOD TO BE HERE AND WANT TO SAY
A FEW WORDS WITH THE P3CO POLICY
DRAFT MODIFICATIONS BEFORE
ADDRESSING DIRECTLY THE
QUESTIONS THAT WERE RAISED ABOUT
THE DURC ISSUES.
AND I'M ALSO GOING TO TRY TO
MAKE REFERENCE AND MODIFY MY
SLIDES A LITTLE BIT IN THE LAST
FEW MINUTES IN REFERENCE TO
REFERENCE TO OTHER SPEAKERS
BECAUSE ONE GENERAL POINT I
WANTED TO START WITH IS I THINK
THERE'S BEEN A POSITIVE
DEVELOPMENT SINCE THE OLD DAYS
IN THINKING ABOUT THE
RELATIONSHIP FROM TOP-DOWN TO
BOTTOM-UP APPROACHES AND
ENCOURAGING GOOD BEHAVIOR ON THE
BIOSAFETY AND BIOSECURITY
QUESTIONS AND I THINK THAT WAS
NOT THERE AS MUCH BEFORE AND THE
IDEAS THOUGH THEY NEED TO BE
WORKED OUT IN MORE DETAIL, THE
IDEA OF MORE JOURNALS REQUIRE
CERTIFICATION BY SOME KIND OF
BODY AND THE IDEAS ABOUT FUNDING
AGENCIES CHOOSING TO PROMOTE
GOOD WELL BEHAVED PREPRINT
SERVERS ARE TWO GOOD EXAMPLES
RAISED IN PREVIOUS TALKS OF WAYS
TO INTEGRATE THE SYSTEM AND MAKE
IT MORE REDUNDANT AND MORE
ENCOURAGING OF RESPONSIBLE
BEHAVIOR.
I THINK THERE'S A NUMBER OF
REALLY TERRIFIC FINDINGS AND
RECOMMENDATIONS IN THE P3CO
WORKING GROUP'S DRAFT FINDINGS.
I WANT TO TALK A MINUTE ABOUT
SOME OF OF THE ONES I THINK
STILL NEED SOME THOUGHT BUT I
WANT TO SAY I'M VERY SUPPORTIVE
OF ALMOST EVERYTHING THAT'S IN
THE DOCUMENT WITH SOME MINOR
QUIBBLES ABOUT SOME OF THEM.
I DO WANT TO SPEND A FEW MINUTES
ON FOCUSSING ON ASPECTS THAT ARE
STILL MISSING.
I THINK THAT ONE OF THE ISSUES
THAT'S BEEN RECURRENT IN THE
HOLD P3CO DEBATE IS WHAT KINDS
OF EXPERIMENTS ARE AT ISSUE.
IN PARTICULAR, THE QUESTION THAT
HASN'T BEEN ADDRESSED IN THE
DRAFT RECOMMENDATIONS OR
PREVIOUS DOCUMENTS IS IT DOESN'T
REALLY MATTER WHERE YOU START.
WHAT MATTERS AND YOU ARE
EXPECTING, REASONABLY
ANTICIPATING TO CREATE A NOVEL
PATHOGEN THAT IS IN ITSELF A
POTENTIAL PANDEMIC PATHOGEN.
THE WAY THE GUIDANCE IS WRITTEN
YOU HAVE TO START WITH A
POTENTIAL PANDEMIC PATHOGEN AND
THEN ENHANCE IT AND WHILE THAT'S
MANY ENHANCED PPPs ARE MADE IT'S
NOT THE ONLY WAY TO DO IT.
IT ONLY GETS HALFWAY TO THE
PURPOSE WHICH IS TO HAVE
OVERSIGHT OF CREATING SOMETHING
THAT MAY POSE A DANGER.
TO THE CONCERN CONCERN IS
TRANSPARENCY LANGUAGE IN THE
DRAFT RECOMMENDATIONS IS TOO
WEAK AND TOO NON SPECIFIC.
IT'S ADOPTING AN IMPLEMENTATION
PLAN AND CONSIDERING POSSIBLE
FUTURE FURTHER ACTIVITIES LIKE A
SUMMARY AND DETERMINATES OF THE
REVIEW.
TRANSPARENCY INCLUDES DISSENTING
VIEWS AND IN AN ARTICLE THERE
WAS A DESCRIPTION OF EXPERIMENTS
BEING PLANNED AT NIAID BY
DR. MOSS WHICH MANY PEOPLE THINK
SHOULD BE REUNDER THIS POLICY.
IF YOU DON'T KNOW WHAT
EXPERIMENTS HAVE BEEN REVIEWED
BY THE BOARD, BY THE REVIEW
COMMITTEES, THEN WE CAN'T KNOW
WHETHER THAT ISSUE HAS BEEN
ADDRESSED OR NOT ADDRESSED.
THAT CAME UP THIS WEEK AND SEEMS
PARTICULARLY RELEVANT BUT THERE
ARE OTHER THINGS HAPPENING AND
OTHER PROPOSALS THAT MAY OR MAY
NOT GET REVIEWED WITHOUT SUCH A
LIST I THINK WE'RE UNABLE TO
KNOW AS CITIZENS WHETHER THE
PROCESS IS WORKING.
THE BENEFIT SIDE OF THE RISK
BENEFIT ANALYSIS CORRECTLY
DESCRIBED ALL OF US AS
SCIENTISTS EXPECT SCIENTIFIC
KNOWLEDGE TO BE BENEFICIAL.
BUT I THINK WHEN YOU REALLY
SUBJECT THE CHAIN OF EVENTS FROM
THE LEAD FROM SCIENCE TO
ENHANCED VACCINES OR ENHANCED
SURVEILLANCE TO SCRUTINY, MANY
ARE HYPOTHETICAL OR GENERAL OR
NOT VERY LIKELY TO WITHSTAND
SCRUTINY.
AND I THINK AS HAS BEEN SAID BY
SEVERAL PEOPLE, THE LEVEL OF
SCRUTINY REQUIRED FOR
EXPERIMENTS THAT POSE A
POPULATION LEVEL RISK SHOULD BE
HIGHER AND THAT NEEDS TO BE MADE
MORE SPECIFIC.
I'M GOING TO SKIP THIS FOR
REASONS OF TIME AND MOVE ON TO
THE POINT THAT I THINK
INFORMATION HAZARDS ARE NOT
THERE IN THE DRAFT
RECOMMENDATIONS.
THOSE MAY BE GREATER IN DURC
MORE GENERALLY THAN THEY ARE IN
P3CO POTENTIAL PANDEMIC PATHOGEN
WORK AND THEY ARE THERE AND
SHOULD BE CORRECTED.
MY COLLEAGUES HAVE WRITTEN A
PIECE THAT WILL BE SHARED OR HAS
BEEN SHARED WITH NSABB AND OTHER
STAKEHOLDERS.
TO ADDRESS THE QUESTIONS ABOUT
IDENTIFYING DURC AND THE ePPP
FRAME WORKS, I THINK THIS IS A
REALLY GOOD IDEA OVER ALL ONE
CONCERN I'LL MENTION IN A MINUTE
BUT I THINK IT'S ADDRESSABLE.
I THINK IT SIMPLIFIES THINGS FOR
INVESTIGATORS BECAUSE THEY HAVE
ONE FLOW CHART AND NOT TWO TO
CONSIDER.
THEY HAVE ONE -- THESE ARE SO
INTERLINKED AND PEOPLE MAY HAVE
CONFUSION ABOUT WHICH OF EITHER
PARTICULAR SET OF WORK FALLS
UNDER.
UNIFYING THE FRAMEWORK WOULD
HELP IF DONE CORRECTLY.
AND I THINK IT WOULD HELP TO
CLARIFY THE DISTINCTIONS BECAUSE
I THINK DIFFERENT PEOPLE HAVE
DIFFERENT IDEAS BETWEEN WHAT
DURC AND PPP WORK IS AND I THINK
HAVING IT ALL IN ONE PLACE WOULD
ALLOW SOME LANGUAGE TO BE
DEVELOPED THAT HELPS PEOPLE
UNDERSTAND AND UNDERSTAND WHY
EACH IS A CONCERN.
THEN I THINK THE PRACTICAL THING
IS IT WOULD ALLOW SHARING AND
BEST PRACTICES BETWEEN THE TWO
REALMS OF REGULATION BECAUSE THE
NATURAL THING WOULD BE TO MAKE
THEM AS SIMILAR AS POSSIBLE WHEN
THAT'S APPROPRIATE.
SO THE PROPOSAL THAT WAS MADE IN
THE PREVIOUS SESSION TO LINK
SERVER SCRUTINY TO ACCEPTABLE
AND TO FUNDERS MAKES SENSE IN
BOTH REALMS AND WHY NOT HAVE A
SINGLE ACTIVITY TO GET IT IN THE
POLICIES RATHER THAN TO -- AND
ALSO ISSUES ABOUT DEALING WITH
UNEXPECTED RESULTS AND POSSIBLE
RE-REVIEW OF PROPOSALS THAT HAVE
PASSED SCRUTINY AND ARISE IN
BOTH SETTINGS AND THE SAME
THOUGHT COULD BE USED AND RISK
ASSESSMENT AND MITIGATION.
I THINK THE ISSUE OF BIOSAFETY
AND BIOSECURITY ISSUES WITH
SEPARATE CONSIDERATION IS AN
IMPORTANT ONE AS WELL AS
TOGETHER.
IN THIS PAPER A FEW YEARS BACK
WE TRIED TO LATE LAID OUT THE
CATEGORIES OF EXPERIMENTS WITH
BIOSAFETY AND BIOSECURITY
CONCERNS IN A 2 x 3 TABLE AND
THE THIRD IS BIOSECURITY
CONCERNS AT THE POPULATION LEVEL
RATHER THAN THE INDIVIDUAL
LABORATORY LEVEL.
I THINK CERTAIN TYPES OF
EXPERIMENTS RAISE EACH OF THESE
AND OTHERS DON'T RAISE SUCH
GREAT CONCERN.
UNIFYING THE POTENTIAL CAN HELP
AND AS THE SHIFTING THE RISK TO
BIOSECURITY AND IT DESCRIBED IN
ePPP AS A SUBSET OF DURC.
I THINK THAT'S TRUE IN THE SENSE
THAT IF SOMETHING HAS AN
ENHANCED POTENTIAL IT HAS THE
POTENTIAL TO BE MISUSED BUT MUCH
POTENTIAL PATHOGENIC WORK RAISES
ISSUES NOT TYPICAL OF DURC SO
THE ISSUES ARE NOT A SUBSET OF
THE ISSUES RAISED BY OTHER DURC
THOUGH THEY'RE A KIND OF DURC.
IT'S A TECHNICALITY BUT I WANT
TO MAKE SURE BIOSECURITY KEEPS
AN IMPORTANT ROLE IF THE TWO
FRAME WORKS ARE UNIFIED.
AND I THINK THE IS SIMPLY TO
UNIFY THE FRAMEWORKS WHILE
KEEPING SPECIFIC CONSIDERATIONS.
I DON'T SEE ANY REASON TO THINK
THE LIST CAN WORK.
CRITERIA ARE THE ONLY SENSIBLE
APPROACH TO REGULATING POTENTIAL
PATHOGEN WORK BECAUSE OF THE
OBSOLESCENCE AND OTHER REASONS.
AS RENE WAS SPEAKING, I PUT THE
SLIDE IN.
SHE MADE THE POINT THAT
ENGINEERING AND NEW TECHNOLOGIES
PROVIDE WAYS TO DO SAFER
EXPERIMENTS THAT GIVE US THE
SAME INFORMATION AS GAIN OF
FUNCTION OF CONCERN.
AND I WANTED TO DRAW ATTENTION
THAT EXPERIMENTALLY CONFIRMS HER
HYPOTHESIS.
EVEN IN THE ABSENCE OF NEW
TECHNOLOGIES, EVERY SINGLE
MUTATION THAT WAS IDENTIFIED IN
THE EXPERIMENTS HAD BEEN
PREVIOUSLY IDENTIFIED AS
IMPORTANT WITH SOME SMALLER
EXCEPTI
EXCEPTIONS IN OTHER NON-GAIN OF
FUNCTION TYPE EXPERIMENTS.
I AGREE WITH HER ASSERTION BUT I
THINK IT'S ATTESTABLE AND
FALSIFIABLE ONE BUT SO FAR IT'S
BEEN PROVEN CORRECT.
I'LL STOP THERE AND LOOK FORWARD
TO SAM'S TALK.
>> THANK YOU FOR THE COMMENTS ON
THE FINDS AND RECOMMENDATIONS
AND THE LETTER WAS INCLUDED WITH
THE OTHER PUBLIC COMMENTS THE
BOARD GOT TODAY.
I THINK EVERYBODY SHOULD HAVE
THAT AND I WANT TO THANK YOU FOR
INCLUDING THAT IN YOUR BRIEFING
AND FOR THE OTHER JUST IN TIME
POWER POINT SLIDES YOU PUT
TOGETHER IN RESPONSE TO HEARING
OTHER TALKS.
OUR LAST SPEAKER FOR THIS
SESSION IS A SENIOR RESEARCH
FELLOW IN SCIENCE AND TECHNOLOGY
SOCIETY AT THE HARVARD KENNEDY
SCHOOL OF GOVERNMENT AND JOINED
THE HARVARD SCHOOL OF NENK
ENGINEER AG APPLIED SCIENCES AND
FOEKSZS ON STUDYING THE HISTORY
AND CONTEMPORARY PRACTICES OF
GOVERNANCE TO LOOK AT
EXPERIMENTAL APPROACHES TO
REFORM THE WAYS WE IDENTIFY AND
GOVERN SECURITY RISK CONCERNS.
HE SITS ON THE COUNCIL OF THE
ENGINEERING BIOLOGY RESEARCH
CONSORTIUM AND SITS ON THE HUMAN
PRACTICES COMMITTEES AND WAS AN
ADVISER TO DARPA'S SAFE GENES
PROGRAM.
THE FLOOR IS YOURS.
>> THANK YOU.
THE SAFE GENES PROGRAM IS A
MOMENT WHERE WE CAN TRY SOME
DIFFERENT ABOUT HOW WE THINK
ABOUT GOVERNANCE SECURITY
CONCERNS AND BIOLOGY.
I THINK THAT'S THE THRUST OF A
LOT OF THE REMARKS I'M GOING TO
BE MAKING TODAY.
I THANK YOU ALL FOR THE
INVITATION.
I'LL FOCUS MY REMARKS ON WHAT A
WAS ASKED ON THE FUTURE OPTIONS
OF OVERSIGHT OF DUAL-USE
RESEARCH AND IT WASN'T DUAL-USE
RESEARCH OF A CONCERN BUT
DUAL-USE RESEARCH.
SO BIOSAFETY'S HAVING A MOMENT
RIGHT NOW WHICH I DON'T THINK I
NEED TO EXPLAIN TO THE BOARD
INVOLVED IN THESE ACTIVITIES.
THERE ARE LOTS OF MOMENTS AND
THINGS HAPPENING NOW WHERE
BIOLOGY IS BEING REDEFINED AND
RE-UNDERSTOOD IN IT'S ROLE IN
SOCIETY AND THERE'S A FOCUS ON
SECURITY.
WHAT THAT MEANS IS WE HAVE AN
OPPORTUNITY RIGHT NOW FOR THE
INSTITUTION LIKE NSABB TO BE
LEADING, THINKING WHAT IT MEANS
TO BE ATTENDING TO AND
UNDERSTANDING WHAT CONSTITUTES
SECURITY CONCERNS IN THIS SPACE.
IF WE THINK ABOUT HOW TO IMPROVE
DUAL-USE RESEARCH GOVERNANCE,
ONE IS LOOKING AT THE LOCAL
CONTEXT AND WHAT'S GOING ON
THERE.
SECONDLY, TO LOOK AT CONCEPTUAL
CONTEXT.
HOW DO WE UNDERSTAND WHAT
BIOLOGY IS TODAY AND ITS
RELATIONSHIP TO SECURITY AND
SOCIETY AND HOW MIGHT THAT HAVE
CHANGED.
AND THE FUTURE CONTEXT LOOKS AT
THE INSTITUTIONAL SUPPORT WE
MIGHT NEED TO ACTUALLY BE
THINKING AND ACTING DIFFERENTLY
IN THE WAYS WE GOVERN.
FIRST LOCAL CONTEXT.
THIS REPRESENTS A LOT OF WORK BY
AN AMAZING TEAM WITH FANTASTIC
POST-DOCS AT STANFORD UNIVERSITY
WHERE WE STARTED WITH THE
UNDERSTANDING THAT LITTLE IS
ACTUALLY KNOWN ABOUT THE LOCAL
LEVEL IMPLEMENTATION OF
HIGH-LEVEL BIOSECURITY
GUIDELINES.
OVER THE LAST SEVERAL YEARS
WE'VE BEEN APPROACHING AND
WORKING WITH A WIDE RANGE OF
ORGANIZATIONS THAT ARE ACROSS
THE LIFE CYCLE OF BIO RISK
MANAGEMENT INCLUDING SOME YOU
HEARD FROM TODAY.
OUR REPORT, WHICH WE'RE
CURRENTLY HAVE IN DRAFT FORM
RIGHT NOW, SHOWS A COUPLE
THINGS.
ONE IS THAT MANY ORGANIZATIONS
ARE HESITANT TO SHARE EVEN THE
PRACTICES THEY WERE DOING TO BIO
RISK MANAGEMENT AND OVERSIGHT
AND WERE UNSURE HOW GOOD THE
PRACTICES WERE BECAUSE THEY
WEREN'T ABLE TO REALLY TALK TO A
LOT OF OTHER ORGANIZATIONS ABOUT
WHAT'S WORKING AND WHAT ISN'T IN
A WAY THAT THEY CAN LEARN FROM.
ONE OF THE THINGS I THINK THIS
HELPS TO BRING TO LIGHT IS THAT
THE SYSTEM THAT WE HAVE FOR
GOVERNING BIOSECURITY CONCERNS
IS BASED ON COMPLIANCE.
WE HAVE THE POLICIES AND THEY'RE
ENACTED LOCALLY AND PEOPLE GET
IN TROUBLE IF THEY DON'T FOLLOW
THEM.
THIS IS NOT A SYSTEM BASED ON
COLLABORATION OR BASED ON
CURIOSITY AROUND WHAT WOULD BE
UNDERSTOOD AND WHO NEEDS TO BE
IN THE ROOM TO DO SOMETHING.
THIS ISN'T SURPRISING IF WE
THINK ABOUT WHERE THE SYSTEM WE
HAVE TODAY CAME FROM.
BIOLOGY WAS THOUGHT OF AS A
SCIENCE.
THAT'S CHANGED IN THE LAST 20
YEARS.
WE MOVED BIOLOGY TO BEING
THOUGHT OF AS A TECHNOLOGY AND
THEN THINK OF BIOLOGY AS NOT
JUST AN ENGINEERING DISCIPLINE
BUT AS A VITAL PART OF THE
FUTURE VISION OF WHAT THE UNITED
STATES OF AMERICA IS IN THE
WORLD.
THE OF RESEARCH AND WE DECIDED
TO DEFINE DUAL-USE RESEARCH OF
CORNER NARROWLY.
WE DID THIS WHEN WE WERE WORRIED
ABOUT ANTHRAX AND OTHER THINGS
AND ON THE BELIEF THE THINGS
THAT NEEDED TO BE BALANCED WAS
SCIENCE AND NATIONAL SECURITY.
IT GOES BACK TO THE FOUNDING OF
NSDD189 THE FIRST PANEL ALSO
TALKED ABOUT.
WE THOUGHT IT WAS A GOOD IDEA
BECAUSE IT GAVE CLEAR POLICY
THAT WAS STRUCTURES AND ON
AGENTS AND EXPERIMENTS OF KNOWN
CONCERN.
WE HAVE SHOWN SOME LIMITATIONS
IN THE PREVIOUS TALKS WE HAD
TODAY.
THE BASIS NOT BEING GREAT BUT A
BIGGER ISSUE WE'RE NOT YET
GRAPPLING WITH IS THIS FORM OF
SECURITY GOVERNANCE ENDENDERS IF
SOMETHING ISN'T P3CO IT'S IN THE
A SECURITY CONCERN.
IT'S A COMPLIANT NOT CURIOSITY
MIND SET AND STILL NARROWLY
FOCUSES ON THE SCIENCE-SECURITY
DIVIDE AND INCLUDING ECONOMICS
AND BROADENING OUT TO MENTAL
HEALTH AND OTHER FORMS OF
SECURITY.
IF THAT'S THE CONCEPTUAL
CONTEXT, THEN WHAT GETS MISSED.
RENE TALKED ABOUT GENE-DRIVE
RESEARCH AND THE INTERNATIONAL
GENETICALLY ENGINEERED CAREERS
COMPETITION WAS THE FIRST
ORGANIZATION TO DEVELOP A POLICY
AROUND GENE DRIVES WHICH IN PART
WAS BECAUSE TEAMS LIKE
UNDERGRADUATE TEAMS WERE TRYING
TO DEVELOP THEM A YEAR AFTER THE
INITIAL PAPERS CAME OUT.
THE OTHER PAPER'S IN THE
CROSSOVER CONVERGENCE BETWEEN
A.I. AND BIOLOGY.
THEY'RE NOT CAUGHT BY THE
CURRENT SYSTEMS WE HAVE IN PLACE
TODAY.
THEY WERE CAUGHT BY FORWARD
THINKING PRACTITIONERS BUT WE
CAN'T RELY ON THEM FOR THE BROAD
SWATH OF ADVANCES WE'LL BE
SEEING IN BIOENGINEERING IN THE
YEARS TO COME.
WHAT'S THAT MEAN FOR THE FUTURE?
IT MEANS WE NEED TO
INSTITUTIONALLY ENCOURAGE
SUPPORT AND EXPERIMENTATION IN
THE GOVERNANCE AND WHAT
CONSTITUTES A SECURITY CONCERN
AND WHO GETS TO DECIDE THAT AND
WHAT SHOULD BE DONE ABOUT IT.
ONE EXAMPLE OF THIS IS THE
OBSERVE PROJECT WHICH I'M NOT
GOING TO GO INTO A LOT OF DETAIL
HERE BUT IT WAS ANOTHER GREAT
EFFORT BY I THINK KATHERINE
MIGHT HAVE BEEN A DOCTORAL
STUDENT AND NOW A POST-DOC AND
BRIDGET IS STILL A STUDENT AND
THEY WERE WORKING ON A SYNTHESIS
COMPANY AND THEY WERE DOING THIS
IN ORDER TO UNDERSTAND HOW TO
NOT ONLY HOW TO IDENTIFY
SEQUENCES OF CONCERNS THAT MAY
FALL OUT OF LISTS BUT AS A
PEDAGOGICAL APPROACH TO BRING A
MORE GROUNDED APPRECIATION OF
THIS CURIOSITY MIND SET OF
SECURITY GOVERNANCE TO
EARLY-STAGE RESEARCHERS.
IT WAS DONE IN COLLABORATION
WITH THE GOVERNMENT BUT SHUT
DOWN A COUPLE DAYS BEFORE IT
LAUNCHED BECAUSE OF CONCERNS WE
ARE NOW WRITING UP IN A PAPER.
THIS IS THE TYPE OF EXAMPLE,
LIKE THE DARPA SAFE GENES
PROGRAMS THAT BROUGHT ME ON AS
AN ADVISER.
IN A PLACE WHERE WE CAN ACT AND
THINK LY BUT SHOWS THE
IMPORTANCE OF INSTITUTIONAL
SUPPORT AND THE REPEATABILITY TO
WHERE THE EXPERIMENTS CAN FALL
FLAT IF IT DOESN'T HAVE SUPPORT.
WHAT CAN NSABB DO TO ADDRESS
THESE CONCERNS I'VE RAISED SO
FAR?
ONE OF THE THINGS THAT I THINK
SHOULD BE DONE IS FOR LACK OF A
BETTER WAY OF SAYING IT TO SAY
THAT ALL RESEARCH IS DUAL USE.
WHEN SAID THIS WHEN BIOSECURITY
WAS STILL BUILDING STEAM AROUND
THE CURRENT SET OF POLICIES BUT
WE'VE LARGELY FORGOTTEN IT AND
IGNORED IT IN THE TEACHING AND
TRAINING OF THE PEOPLE WE THINK
ARE GOING TO BE LEADING THE
CHARGE AND BRINGING NEW
INNOVATIONS AND BIOLOGY TO
SOCIETY.
SO I THINK THE NSABB SHOULD BOTH
WITHIN ITS CURRENT MANDATE AND
THROUGH A NEW MANDATE, SEEK TO
SHIP BIOSECURITY GOVERNANCE
SYSTEM FROM A SYSTEM THAT
ATTENDS TO THE ECONOMICS OF
SOCIETY.
I'VE LISTED THE POLICIES HERE
WHICH I WILL LEAVE OUT FOR THOSE
TO SEE FOR A LITTLE BIT BUT IT
BUILDS OFF THE GUIDELINES
ALREADY IN THE EXISTING POLICY
THAT ALL RESEARCH CAN BE USED
CONSISTENT IN A MANNER THAT
RESULTS IN HARP.
THE QUESTION IS HOW DO WE A HOW
DO WE APPROACH THAT DIRECTLY?
-- RESULTS IN HARM.
AND WHAT RESEARCH SHOULD BE
SUBJECT TO THE CONCERNS OF THOSE
COMMUNITIES THAT ARE MOST LIKELY
DISAFFECTED BY THEM?
AND WE SHOULD HAVE AN EXPLICIT
STATEMENT THAT EXPERIMENTATION
OF BIO SECURITY GOVERNANCE IS
SOMETHING TO BE FOSTERED.
I LEAVE IT THERE.
I LOOK FORWARD TO THE QUESTIONS
AND THANK YOU FOR HAVING ME ON.
>> SAM, THANK YOU.
IF THE BOARD MEMBERS CAN TURN
YOUR VIDEO BACK ON AND WE'RE
READY TO ASK THE SPEAKER FINAL
QUESTIONS OR THOUGHTS.
ALLOWING FUNDERS AND RESEARCHERS
AND INSTITUTES TO EXPERIMENT.
ONE THING WE LACK IS THE
EXPERIMENTAL BASIS TO NOW WHAT
WORKS AND DOESN'T WORK AND WHAT
YOU'RE SAYING IN YOUR LAST
BULLET.
HOW DO YOU ENVISION THE LIFE
SCIENCE ENTERPRISE ACCOMPLISHING
THAT?
>> ONE THING I'LL SAY AND I'D
LOVE TO HEAR RENE'S THOUGHTS ON
THIS AND ONE THING I'LL SAY IS
THE EXPERIMENTS ARE ALREADY
HAPPENING.
IF YOU THINK OF THINGS LIKE --
THIS BOARD ITSELF IS IN A WAY AN
EXPERIMENT.
THE FBI WEAPONS OF MASS
DESTRUCTION AND ENVISION THE
FBI'S ROLE IN RELATION TO
BIOLOGY AND SECURITY.
THERE'S AN EXPERIMENT WHERE THE
PARTICULAR MODEL OF BEING A
YEARLY COMPETITION ALLOWS FOR
ITERATION AND REFLECTION ON A
STRUCTURED BASIS AND THEY LEAN
INTO THAT WITH THE VICE
PRESIDENT OF SAFETY AND SECURITY
TO CONTINUOUSLY BE REFLECTING ON
WHAT THE ASSUMPTIONS ARE THEY
ARE MAKING INVITING A WIDE SET
OF STOCKHOLDERS TO ASSESS
WHETHER WHAT THEY'RE DOING IS
ACCEPTABLE AND ADEQUATE AND
TRYING OUT SOMETHING DIFFERENT
THE NEXT YEAR.
THESE ARE ALL MODELS THAT CAN BE
BUILT UPON AND THERE ARE OTHERS.
WHAT I THINK IS THERE'S STRONG
INSTITUTIONAL INCENTIVE TO STAY
THE COURSE AND TO GO ALONG THE
EXISTING PATHWAYS OF KNOWN
CONCERN AND OF KNOWN OVERSIGHT.
I AM STILL WORKING ON HOW TO
BREAK THAT.
>> CHANGE IS HARD.
ALEX.
>> I'D LIKE IT HEAR THAT IT'S
PURELY NOT A SCIENTIFIC QUESTION
TO ASK ABOUT WHEN THE RISKS
ASSOCIATED WITH RESEARCH ARE
WORTHWHILE RELATIVE TO THE
PROSPECT AND POTENTIAL BENEFITS
WE'RE TRYING TO GENERATE.
I THINK WE ALL AGREE ON THAT.
THAT'S WHY THERE NEEDS TO BE AN
INTERDISCIPLINARY PANEL THAT
LOOKS AT THESE THING BUT I WANT
TO ASK A MORE NARROW QUESTION
WHICH GETS TO THE SLIDE THAT
MARC LIPSITCH SHOWED AT WHAT
LEVEL SHOULD JUDGMENTS BE MADE
ABOUT WHAT THE RELATIVE
SCIENTIFIC MERITS OF PARTICULAR
METHODOLOGIES ARE BECAUSE WHEN
WE CONSIDER A METHODOLOGY AND
THE MERITS AND THE RISKS AND THE
MULTI-DISCIPLINARY DISCUSSION IS
A CLEAR SENSE OF WHAT IS AT
STAKE FROM THE SCIENTIFIC SIDE.
SO WHAT LEVEL ARE WE GOING TO
ASK LOCAL INSTITUTIONS TO MAKE
JUDGMENTS ABOUT THE SCIENTIFIC
QUESTIONS?
IS IT AT SOME LARGER REVIEW
STAGE OR SHOULD THERE BE A
COMMUNITY CONSENSUS ABOUT
WHETHER PARTICULAR METHODOLOGIES
HAVE BECOME WHERE WE SHOULD USE
THEM OR ALTERNATIVES THAT ARE
LOWER RISK AND WE SHOULDN'T USE
THOSE METHODOLOGIES AT ALL?
>> I'LL START BUT I'M ANXIOUS TO
HERE WHAT OTHERS HAVE TO SAY.
YOU IDENTIFIED A HARD QUESTION.
I THINK SOME ACQUISITIONS AS I
SEE IT ARE THAT WHEN THE WORSE
THING YOU CAN DO IS WASTE MONEY,
THEN I THINK SCIENCE --
ADVANCING SCIENCE IS A GOOD
ENOUGH REASON TO DO AN
EXPERIMENT THAT MIGHT TURN OUT
TO NOT BE A VERY GOOD
EXPERIMENT.
ALL EXPERIMENTS CAN BE NOT
INFORMATIVE IF IN SOME
CIRCUMSTANCES, EVERY GRANT
PROPOSAL IS A RISK FOR SOME
AGENCY.
IF LIVES ARE AT STAKE AND THE
EVALUATION IS THERE'S A CHANCE
THAT'S WORTHY OF CONCERN OF
STARTING A PANDEMIC, THEN THE
JUSTIFICATION HAS TO BE IN TERMS
OF LIVES SAVED.
I DON'T KNOW HOW YOU WEIGH SMALL
PROBABILITIES ONLY BOTH SIDES.
THINK THAT'S A HARD THING.
I THINK AN AWFUL LOT OF THE
SOLUTION CAN COME FROM THAT
PRINCIPLE AND ANOTHER PRINCIPLE
WE WROTE ABOUT A FEW YEARS BACK
WHICH IS THE QUESTION SHOULD NOT
BE DO THIS EXPERIMENT OR DON'T
DO THE EXPERIMENT.
IT SHOULD BE DO THE EXPERIMENT
OR DO THE NEXT SAFE ALTERNATIVE
TO THAT EXPERIMENT.
I THINK AN AWFUL LOT OF THE
ALLEGED BENEFITS VANISH OR
BECOME MUCH SMALLER WHEN YOU
TAKE THE RIGHT COMPARISON IN
THAT SENSE AND THAT WAS SORT
OF -- I THINK WHAT RENE'S POINT
WAS SAYING AND WHY I WANT TO
BOLSTER IT.
THAT DOESN'T ANSWER THE QUESTION
FULLY BUT I THINK THOSE ARE TWO
USEFUL PRINCIPLES.
>> I CAN JUMP IN AND FOLLOW-ON.
IN TERMS OF WHAT LEVEL AND WHEN
DOES THIS NEED TO BE ASSESSED, I
THINK THERE'S A LOT OF QUESTIONS
TO DIG IN AROUND THAT AS BEFORE
THE EXPERIMENT IS DONE IS THE
IDEAL TIME TO BE DOING THAT AND
WHO DETERMINES THE RISK AND
OPPORTUNITY AND BENEFIT IS ARE
IMPORTANT.
ARE THE COMMUNITIES WHO ARE
LIKELY TO BE MOST IMPACTED BY
THAT TECHNOLOGY ARE THEY PART OF
THAT DECISION MAKING?
SO SOMEBODY MENTIONED COMMUNITY
CONSENSUS.
HOW ARE WE ENGAGING TO HAVE A
VOICE AND A SAY.
AT THE LOCAL INSTITUTIONAL
REVIEW BOARD LEVEL THESE ARE
SYSTEMS THAT MANY SCIENTIFIC --
MANY INSTITUTIONS HAVE BUT I DO
KNOW WITH THE GENE DRIVE
TECHNOLOGY EARLY ON THIS WAS
APPROVED AND LOOKS LIKE YOUR
STANDARD RUN OF THE MILL
TRANSGENIC EXPERIMENT.
THERE'S POTENTIAL FOR DUAL-USE
AND ACCIDENTAL MISUSE WITH US
NOT DETERMINED BY THE BOARDS AND
HOW ARE YOU MAKING SURE THERE'S
EXPERTISE ON THE BOARDS FROM
PEERS TO HAVE AN EXPERT VIEW ON
THAT TECHNOLOGY.
OFTEN THE DEVELOPING TECHNOLOGY
CAN BE BLIND TO THE POTENTIAL
RISKS.
DEFINING AND MAKING SURE WE'RE
BEING RIGOROUS IN THAT
DEFINITION OF THAT RISK AND
BENEFIT I THINK IS A DIRECTION
WE NEED TO GO.
>> ONE THING I'LL ADD HAVING THE
RESEARCH WORRYING ABOUT THE
RESEARCH STAGE ISN'T THE ONLY
PLACE WE CAN BE LOOKING HERE.
THE PRE FUNDING REVIEW AS WELL
AND THE INSTITUTES AT THE
DEPARTMENT OF ENERGY HAS AN
EXTENSIVE REVIEW PROCESS BEFORE
IT FUNDS WORK THAT INCLUDES THIS
REVIEW OF FROM PEOPLE LIKE ME
WHO ATTEND TO THE SAFETY,
SECURITY AND ENVIRONMENTAL,
LEGAL, ETHICAL AND OTHER
ASPECTS.
THAT'S A LAYERED REVIEW PROCESS
BEFORE THE RESEARCH IS EVEN
CONDUCTED.
>> THANK YOU VERY MUCH.
I WAS WONDERING IF THE PANELISTS
CAN DIG INTO A LITTLE BIT MORE
THE CONVERSATION ABOUT ROLE AND
RESPONSIBILITIES.
I KNOW THIS WAS IN THE DRAFT
RECOMMENDATIONS FOR THE P3CO
GROUP BUT IT SEEMS RELEVANT TO
THE DURC RECOMMENDATIONS AND
COMMUNICATING RISK AND BENEFIT
AND TALKING ABOUT THE CHALLENGES
OF ASSESSING RISK AND BENEFIT
AND LOTS OF COMMUNICATION ABOUT
HOW TO TALK ABOUT AND AS A
TAX-PAIR FUNDED ORGANIZATION WE
THINK ABOUT PERCEPTIONS AND
RESEARCH WE FUND.
WHAT ARE THE JOBS AND ROLES OF
THE DIFFERENT PLAYERS IN THE
SYSTEM OF COMMUNICATING WITH
FIDELITY THE POTENTIAL RISKS AND
BENEFITS?
>> I'D LOVE FOR RENE TO START
THIS ONE.
>> I'M HAPPY TO TAKE A SHOT AT
IT.
AT EVERY LEVEL STAKEHOLDERS HAVE
A ROLE HERE WHETHER YOU'RE THE
FUNDER OR THE RESEARCHER OR THE
POST-DOC OR THE UNDER GRADUATE
DOING THE EXPERIMENT.
EVERYBODY HAS A RESPONSIBILITY
TO UNDERSTAND THE RISK AND BE
ABLE TO COMMUNICATE THEM.
ONE COMPONENT AS YOU WERE SAYING
YOUR COMMENTS I WAS THINKING
ABOUT IS WORKFORCE DEVELOPMENT
AND HOW ARE WE BUILDING THAT IN
WHETHER THEY'RE ON THE NSABB OR
AT AN INSTITUTION TO RECOGNIZE
SOME OF THOSE RISKS?
IS THAT RESPONSIBILITY OF THE
SCIENTIFIC COMMUNITY TO MAKE
SURE WE'RE TRAINING THE NEXT
GENERATION OF SCIENTISTS TO DO
THAT AND I'LL FLAG THE WORKFORCE
DEVELOPMENT EFFORT WHERE IT
ADDRESSES HUMAN PRACTICE FOR
BIOSECURITY AND WHAT THE RISKS
AND BENEFITS AND HOW ARE YOU
ENGAGING COMMUNITIES IS BAKED
IN.
IT'S A MUST-HAVE, YOUR PROJECT
WON'T GO THROUGH IF IT DOESN'T
EXIST AND SHOULD BE STANDARD
PRACTICE IN MY OPINION TO BE
COACHING EVERYBODY.
WHATEVER THEIR ROLE OR
RESPONSIBILITY MAY BE IN THEIR
CAREER AND AS IT CHANGES OVER
TIME IT SHOULD BE A THREAD.
AND IT DIDN'T EXACTLY ANSWER
YOUR QUESTION BUT I WANT TO GO
BACK TO EVEN DEVELOPMENT OF
SCIENTISTS AND MAKING SURE THIS
IS BUILT IN.
>> I APPRECIATE THE QUESTION AS
WELL.
I'M NOT SURE EVERYBODY'S GOING
TO LIKE MY ANSWER THOUGH WHICH
IS I THINK THE BEST THING WE CAN
DO AS A GOVERNMENT IS TO BEGIN
CHANGING THE PERCEPTION THAT
SCIENCE -- THAT EVERYBODY THINK
SCIENCE DOES GOOD.
THIS IDEA THAT RISK AND BENEFITS
IS GETTING AT IT AND THERE'S
ALWAYS GOING TO BE SOME RISK.
THE MORE WE TURN ATTENTION TO
WELL, WHO WILL BEAR THE BURDEN
OF RISK?
AND NO RESEARCH IS RISK FREE AND
DRIVING THAT HOME TO EVERYBODY
DOING THE RESEARCH IN A WAY TO
SHOW IT'S OKAY TO HAVE THE
CONVERSATION AROUND POTENTIAL
CONCERNS THAT COME UP FROM THE
WORK AND NOT JUST OKAY BUT
SOMETHING TO BE ENCULTURED.
THAT'S WHAT IT'S GOING IN
POTENTIAL TO HUMAN PRACTICES AND
TURNING ATTENTION TO THE WAY THE
BIOLOGY DONE SITS WITHIN THE
SOCIETY AND THE SECURITY
COMPONENT IS ONE OF THOSE.
IT'S NOT SOMETHING -- THE VAST
MAJORITY OF TRAINING THAT GOES
ON ACROSS RESEARCH INSTITUTIONS
ACROSS THE UNITED STATES.
IT TENDS TO START -- IT DOESN'T
TEND TO START FROM THE POSITION
OF ALL RESEARCH IS DUAL-USE.
IT STARTS FROM THE POSITION OF
YOU'RE HERE BECAUSE YOU WANT TO
CHANGE THE WORLD FOR GOOD.
OH, AND TRY NOT TO DO BAD
THINGS.
THAT'S A VERY DIFFERENT STARTING
PLACE AND LEADS TO SYSTEMIC
OCCLUSION OF THE ABILITY TO
THINK WHAT YOU'RE DOING MIGHT BE
HARMFUL.
>> IS IT POSSIBLE TO CHANGE THE
PARADIGM SO WE START WITH THE
NEXT GENERATION?
>> YES, THAT'S MY CAREER.
>> THE PARADIGM HAS CHANGED
BEFORE.
IT NEEDS TO CHANGE AGAIN AND
NEEDS TO HAPPEN NOW AND THE
NSABB IS WHY IT HAS TO BE
ENCULTURED FROM THE TOP AND
BOTTOM AND MIDDLE LEVEL AND THE
NSABB HAS AN OBLIGATION AND DUTY
TO START SPEAKING IN A WAY THAT
IS ABOUT ALL RESEARCH BEING
DUAL-USE.
WE NEED TO APPRECIATE AND ACCEPT
THE FACT THAT PEOPLE KNOW NOT
EVERYBODY WILL GET THE BENEFITS
OF BIOLOGY.
THEY'LL BE DISTRIBUTE D
INEQUITABLY.
>> ANOTHER PERSPECTIVE IS TO TRY
TO COMMUNICATE WHAT IS IT
SCIENTISTS -- HOW DO SCIENTISTS
MAKE DECISIONS?
IT'S NOT THAT WE'RE LED BY OUR
SCIENTIFIC KNOWLEDGE TO DO THE
INEVITABLE NEXT EXPERIMENT AND
THE INEVITABLE NEXT EXPERT AND
THERE'S ONLY ONE WAY TO DO IT
AND THERE'S A SPIRIT THAT LEADS
US IN THE RIGHT DIRECTION.
WE THINK ABOUT WHAT'S THE
CHEAPEST WAY TO DO THIS AND THE
FASTEST WAY TO DO THIS THAT GETS
ME A GOOD ANSWER AND THE WAY
SOMEONE WOULD LIKE TO FUND TO
GIVE ME A GOOD ANSWER.
FOR EVERY EXPERIMENT WE DO WE
REJECT DOZENS OF ALTERNATIVES.
SOME EXPLICITLY AND SOME WE
DON'T CONSIDER.
WHAT TURNS OUT TO BE THE SIGN OF
A GOOD EXPERIMENT IS SOMEONE WHO
GETS AHEAD WITH TWO STEPS RATHER
THAN ONE STEP IN THE KNOWLEDGE
PATHWAY.
THAT'S ALSO ABSTRACT BUT THE
IDEA THAT WHAT WE'RE DOING IS
TRY TO FIND OUR WAY TO ANSWERS
AND WE CONSIDER THE COSTS, HARMS
AND BENEFITS IS A USEFUL WAY TO
THINK ABOUT IT AND HOW TO
COMMUNICATE IT AS OTHERS ARE
BETTER POSITIONED TO SAY.
>> THANK YOU.
DURC CAME THE THINK REPORT BY
2005 IT BECAME A MEME AND THERE
WAS NO WAY TO ACTUALLY GET IT
OUT OF THE SYSTEM.
AND I AGREE THAT LISTS DON'T
WORK.
THEY'LL BE A 20th CENTURY REM
NENT AND THE SELECT AGENT LIST
CAUSES PROBLEMS FOR ALL KINDS OF
PEOPLE AND FOR THOSE LIKE US
TRYING TO FIX THIS, LET'S NOT
LET IT GET TO THE POINT WHERE
CONGRESS STARTS LEGISLATING
BECAUSE WE'LL HAVE TO DEAL WITH
A MORE DIFFICULT SITUATION
WHETHER THEY'RE GOOD
RECOMMENDATIONS OR NOT YOU'LL
STILL HAVE TO DO THEM.
IT'S SELF-ORGANIZATION TO
SELF-REGULATE IS THE WAY TO GO
JUST LIKE THEY DID WITH THE RACK
IN 1975.
THE BOTTOM LINE IS SAFETY AND
SECURITY AND THE PROBLEM IS
ESPECIALLY FOR SECURITY THERE'S
NO REAL INCENTIVES FOR IT.
THE INCENTIVES ARE TO PUBLISH
GOOD PAPERS IN SCIENCE AND
NATURE OR THE NEW ENGLAND
JOURNAL FOR CAREER ADVANCEMENT
AND TO MAKE PROGRESS AND
DISCOVER NEW DRUGS AND MAKE NEW
SCIENTIFIC DISCOVERIES.
AND I THINK THAT ONE OF THE
THINGS WE REALLY MISSED HERE IS
HOW TO INCENTIVIZE THE SAFETY
AND SECURITY SUCH THAT
SCIENTISTS AND PUBLIC FIGURES
AND THE GOVERNMENT SEES IT AS
SOMETHING WORTH DOING NOT JUST
SOMETHING YOU SHOULD DO BECAUSE
IT'S THE RIGHT THING TO DO.
YOU JUST CAN'T DEPEND ON
EVERYBODY DOING THAT ESPECIALLY
WHEN YOU START GETTING TO THE
LARGER INTERNATIONAL ISSUES AND
PRIVATE SECTOR ISSUES.
I'VE KNOWN MARK FOR SOME TIME
AND WHAT DO YOU SEE AS HOW TO
INCENTIVIZE THIS AND HOW TO MAKE
SCIENTISTS AND INSTITUTIONS WANT
TO DO THIS RATHER THAN HAVE TO
DO IT UNDER DURESS?
>> PEOPLE ARE STARTING TO SAY
HOW DO WE INTERGAIT -- INTEGRATE
THE INCENTIVES FROM THE FUNDERS
AND JOURNALS AND IF JOURNALS
REQUIRE SOME KIND OF
CERTIFICATION OF HAVING THOUGHT
THROUGH AND GOTTEN SOME KIND OF
EXTERNAL VALIDATION IN HIGH-RISK
EXPERIMENTS IT SOLVES THE
PROBLEM THE GOVERNMENT CAN'T
REGULATE THINGS IT DOESN'T FUND
AS EASILY BECAUSE IT'S THE SAME
AS IRBs.
EVERYBODY IS SUBJECT TO THE IRBs
WHICH SOMETIMES MORE THAN THEY
SHOULD BE ARGUABLY BUT THAT'S
WELL BEYOND GOVERNMENT FUNDING.
I THINK THAT KIND OF INTEGRATION
OF DIFFERENT INCENTIVES FROM
DIFFERENT PARTS OF THE SYSTEM
AND AS YOU SAID IT DOESN'T HAVE
TO BE -- FOR CERTAIN THINGS IT
DOESN'T HAVE TO BE EVERY JOURNAL
BECAUSE MANY PEOPLE RESPOND TO
THE INCENTIVES OF A FEW JOURNALS
AND WON'T DO WORK THAT WILL ONLY
BE PUBLISHABLE IN SOME PLACE
THEIR COLLEAGUES DON'T THINK
HIGHLY OF.
THAT'S A START, I THINK.
>> THERE'S A COUPLE OTHER AREAS
FOR INCENTIVATION AND GOVERNMENT
ISN'T THE ONLY PLACE DUAL-USE
RESEARCH WILL OCCUR AND MAKING
SURE INDUSTRY IS ENGAGED AND
DEVELOPING PROCESSES AND THE
DOUBLE-STRAND DNA GUIDANCE IS
VOLUNTARY MOST COMPANIES ARE
GOOD CITIZENS BUT SINCE
SEQUENCING AND SYNTHESIS COSTS
ARE DROPPING IT BECOMES MORE OF
A BURDEN TO DO THE SCREENING AND
WHO CAN JUMP IN AND HELP PROVIDE
FUNDING TO SUPPORT THOSE
ACTIVITIES IN INDUSTRY AS WELL.
I'D ALSO ARGUE FOR THE VENTURE
FUNDING, THEY'RE FUNDERS AND
BUILDING THIS INTO THEIR
BUSINESS PLANS WITH THEIR NEW
COMPANIES.
THEY MUST HAVE A REVENUE PLAN
AND CYBER SECURITY PLAN AND WHAT
IS YOUR BIOSECURITY PLAN AND
YOUR PLAN TO BE READY FOR THE
NEXT PANDEMIC AND HOW IS YOUR
WORKFORCE GOING TO BE SUPPORTED?
THAT COULD ALSO POTENTIALLY
TOUCH ON INSURANCE AS WELL.
IT'S BEEN A HARD NUT TO CRACK.
THERE'S INCENTIVES THROUGH
INSURANCE SO INSTITUTES CAN
POTENTIALLY HAVE A MODEL TO GET
INSURED IF THEY AGREE TO PUT THE
PROCESSES IN PLACE AND HAVE
INCENTIVATION THROUGH INSURANCE.
>> VERY QUICKLY THE INCENTIVE
STRUCTURE CAN BE THERE AND HOW
RENE SPOKE EARLIER ABOUT
FOCUSSING RESEARCH AND
INNOVATION ON AREAS OF
BIOSECURITY NEED.
BUILDING UP CAPACITY TO SAY, OH,
THIS IS A PROBLEM WE ALL AGREE
IS A PROBLEM WE NEED TO TEND TO
AND THESE KINDS OF INCENTIVES
CAN EXIST QUICKLY WITHIN
FUNDING.
THE OTHER THING I WOULD SAY IS
TO LOWER THE STAKES FOR THE
PEOPLE EXPERIMENTING NOVEL
GOVERNANCE APPROACHES.
IF SOMETHING GOES WRONG IN AN
IBC IT SHOULDN'T BLOWUP IN A
NATIONAL CONVERSATION
NECESSARILY.
TO HAVE METHODS WHERE -- TO
UNDERSTAND THE PROBLEMS WILL
COME UP AND HAVE MORE DEVELOPED
METHODS FOR ADDRESSING POTENTIAL
PROBLEMS WITH THE GOVERNANCES WE
HAVE WITHOUT THEM BECOMING MAJOR
POLITICAL ISSUES.
>> WE HAVE TWO MORE QUESTIONS
AND WE'RE GETTING CLOSE TO END
TIME BUT I THINK WE HAVE TIME TO
GET MARC AND PAMELA IN.
MARC, YOU'RE NEXT.
>> THANKS.
I'LL REFER TO MY COMMENTS IN THE
2020 NSABB MEETING.
NUMBER ONE, I WANT TO SAY I'M
NOTE AWARE OF SCIENTISTS I WORK
WITH TO FIND A FASTER, EASIER
WAY OF WORK WITHOUT A COMMITMENT
TO IMPORTANT PROGRESS BECAUSE
THEY DO HAVE RISK ASSOCIATED AND
THOSE WHO WORK WITH THEM.
THAT'S IMPORTANT TO NOTE THERE'S
NOT A CYNICAL COMPONENT TO THIS
FOR PEOPLE WHO WORK ON THE
PATHOGENS.
I WISH THERE WERE MORE
EXPERIMENTAL SCIENTISTS ON THE
PANEL TODAY.
I WANTED TO ASK THE QUESTION
BECAUSE IT'S SOMETHING I'VE
ASKED BEFORE AND I DON'T HEAR
ANY CONVERSATION ABOUT HOW
SCIENCE IS PERFORMED AND BENEFIT
IS EASIER TO PREDICT AND RISK IS
HYPOTHETICAL.
THERE'S A CERTAIN MUTATION BEING
INTRODUCED AND IS THERE A
PROPOSAL SAYING IF I DO
EXPERIMENT A , I MIGHT DO
EXPERIMENT B THAT IS MORE OF A
WILD TYPE VIRUS AND IT SEEMS
LIKE SCIENCE PERFORMS AND IT
DOESN'T THROW OUT THE BABY WITH
THE BATH WATER WITH GLOBAL RISK
AND MAYBE YOU CAN ADDRESS THAT.
>> MAKING SURE WE ONLY DO THE
ASSESSMENT AT THE BEGINNING OF
THE BODY OF WORK AND HAVING THE
TEAM AVAILABLE TO DO THAT IS
IMPORTANT AND TAKES FUNDING TO
HAVE AN ADVISORY THAT CAN
CONTINUE TO LOOK AT THE
EXPERIMENTS AND BE PRESENT FOR
THE UNEXPECTED.
I THINK IN YOUR PROPOSAL LOOKING
AT ITERATIVE AND PLANNING AHEAD
SAY -- IS A GREAT WAY TO DO IT
AN THERE'S ALWAYS SURPRISES IF
SCIENCE STAYS TRUE TO ITSELF AND
BUILD THAT IN FROM THE BEGINNING
AND REVISIT THAT OVER AND OVER.
>> AND INVOLVE AN ITERATIVE PLAN
SAYING IF WE DO A WE DO
ADDITIONAL REVIEW IF WE GET B WE
MOVE ON FORWARD SO THAT IN
FACT -- I AGREE WITH THE REVIEW
BUT ALLOWS THAT KIND OF WORK TO
GO FORWARD AND WITH GUIDELINES
IN PLACE FOR THE SCIENCE AND THE
PEOPLE DOING IT.
>> I NOW UNDERSTAND IT BETTER.
IT MAKES A LOT OF SENSE.
I WANT TO SAY I'M NOT SURE ABOUT
THE COMMENT OF DOING THINGS IN A
FASTER THINGS OR IF YOU DO A
HARD OR EASY EXPERIMENT AND GAVE
THE SAME ANSWER YOU DO THE
EASIER ONE.
I MEANT THAT IN THE GOOD SENSE
OF OPTIMIZING YOUR USE OF
RESOURCES NOT IN THE SENSE OF
TAKING SHORTCUTS.
>> WHAT DO YOU THINK ABOUT
PROVIDING A TEMPLATE FOR SOMEONE
TO FOLLOW AND WHICH WAY THEY'D
BE GO, NO-GO?
WE DON'T PUT THAT IN ANY OF OUR
CONVERSATIONS I'M AWARE OF AND
WOULD LIKE TO SEE SOMETHING LIKE
THAT.
I THINK THAT WOULD WORK.
>> IT MIGHT GET VERY LONG.
IT MAKES TOTAL SENSE IN
PRACTICAL TERMS.
I CAN IMAGINE A STUDY SECTION
SAYING FIRST OF ALL, IT'S TOO
COMPLICATED I CAN'T UNDERSTAND
IT.
SECONDLY, THEY OBVIOUSLY
DON'T -- WE ALL KNOW THE WORK
THAT'S ALREADY BEEN DONE GETS
FUNDED BETTER THAN WORK THAN
HASN'T ALREADY BEEN DONE AND
IT'S A CLUE YOU HAVEN'T ALREADY
DONE THE WORK AND THEREFORE TO
BE FOR A MOMENT A LITTLE BIT
CYNICAL, I THINK YOU'D HAVE TO
HAVE A CERTAIN KIND OF REVIEW
GROUP THAT WAS TIKE -- TAKING A
DIFFERENT APPROACH FROM WHAT
SOME REVIEW GROUPS DO.
>> REVIEW ENTITIES HAVE THAT
PROCESS IN PLACE.
THEY BUILD THEM UP ON A CASE BY
CASE BASIS BUT WE DON'T KNOW HOW
EFFECTIVE THEY'RE WORKING AND
DON'T KNOW THE GROUP.
THE WORK IS THERE IT'S JUST NOT
HEARD AND WE DON'T HAVE A SYSTEM
TO SUPPORT THE SHARING OF THAT.
>> PAMELA, YOU'RE NEXT AND WE'LL
GO TO PAMELA FIRST.
>> I'M THINKING ABOUT SOMETHING
RENE SAID THAT RESONATED FOR ME
AND HOW DO WE MAKE POLICIES IN A
WORLD WHERE BIOLOGY IS JUST
MOVING SO FAST?
AND SO I WANT TO ASK ABOUT WHAT
HAPPENS WHEN WE BECOME SO GOOD
AT PREDICTING HOW BIOLOGY
BEHAVES THAT YOU DON'T EVEN HAVE
TO DO THE EXPERIMENTS?
YOU PUT UP THE PAPER ABOUT THE
DRUGS THAT CAN ACT WITH
DIFFERENT ANTIBIOTICS AND PEOPLE
ARE PUBLISHING PAPERS ABOUT
VIRUSES THAT CAN EVADE THE
IMMUNE RESPONSE BY PREDICTION.
WHAT DO YOU THINK ABOUT THAT.
>> WE DON'T HAVE TO THINK OF THE
POLICY BEHIND THE BIOLOGY.
THERE'S EVERY REASON TO THINK
THE WAY WE TRAIN OUR BUY
OGOLOGOG --
BIOLOGISTS NEED TO INCORPORATE
THE QUESTIONS ON WHAT KIND OF
THE WORK WITHIN THE WIDER
CONTEXT.
>> THINK IT'S SOMETHING WE HAVE
TO ANTICIPATE.
THIS GOES BEYOND OUR BIOLOGIST
AS OUR STUDENTS ARE DOING MORE
A.I. LEARNING.
THIS IS SO TEMPTING FOR THEM TO
THINK ABOUT HOW DO I MAKE A BAD
VIRUS.
AND THEN FORMULA FOR HOW TO DO
THESE THINGS WILL START TO
BECOME MORE AND MORE OF A
REALITY.
>> RENE.
>> I LOVE TO THINK ABOUT WHEN
BIOLOGY GETS SO GOOD WE'RE ABLE
TO PREDICT IT.
I THINK THERE'S A TREMENDOUS
OPPORTUNITY THERE TO AGAIN GOING
BACK TO MY COMMENTS ABOUT EARLY
WARNING AND BIO SURVEILLANCE AND
IF WE CAN PREDICT SOMETHING AS A
POTENTIAL BAD OUTCOME WE CAN
START TO PROACTIVELY LOOK FOR IT
BUT ONLY IF WE HAVE THE
SURVEILLANCE SYSTEMS IN PLACE TO
DO SO.
THERE'S A FEW EXAMPLES FROM
PAPERS THAT WE CAN BE
PROACTIVELY LOOKING FOR TARGETS.
TO YOUR POINT, AS WE HAVE THE
ENGINEERED BIOLOGICAL FUTURE WE
HAVE TO START NOW NOT ONLY
UNDERSTANDING HOW TO
DIFFERENTIATE ONE ORGANISM FROM
ANOTHER IF IT'S GOOD OR BAD BUT
ALSO MESSAGING THE PUBLIC AND I
REMEMBER WHEN I WAS AT DARPA WE
USED TO JOKE, I'LL SAY, IF WE
WENT INTO THE CHARLES RIVER AND
SEQUENCED THAT WATER, THERE'S
GOING TO BE ENGINEERED THINGS IN
THAT WATER AND SO ALWAYS AN
EXPERIMENT YOU'D NEVER DO
BECAUSE HOW WILL YOU MESSAGE
THAT?
WHAT IS THE PUBLIC GOING THINK?
GMOs AREN'T ALL BAD.
THESE ARE THINGS WE NEED TO
START NOW TO BE READY FOR THAT
FUTURE THAT YOU DESCRIBE AND
THERE'S TREMENDOUS OPPORTUNITY
THERE EXCITING TO PURSUE.
YOUR LAST POINT WITH THE
TEMPTATION TO DO THINGS THAT ARE
BAD, I THINK RED TEAMING IS ONE
OF THE BEST THINGS YOU CAN DO ON
PROJECTS BUT YOU HAVE TO CREATE
A SAFE ENVIRONMENT.
DON'T KNOW I HAVE THE PERFECT
ANSWERS TO THOSE QUESTIONS BUT I
DO KNOW FROM DARPA WHEN WE
BROUGHT IN SOME EXPERT
PROFESSORS TO RED TEAM PROGRAMS
WE WERE WORKING ON IT WAS
ENLIGHTENING TO HAVE OTHER
PERSPECTIVES FROM OTHER FIELDS.
I GUESS MOST OF US ON THE CALL
HAVE A BACKGROUND IN BIOLOGY AND
GENETICS ABOUT THE WHAT ABOUT
OTHER FIELDS THAT CAN BRING A
DIFFERENT PERSPECTIVE AND
POTENTIAL FOR RISK.
IT'S AN IMPORTANT POINT.
MAKE SURE CARMELLA GETS TO JUMP
IN.
>> THERE WAS POINT BROUGHT UP
ABOUT INCENTIVES AND RESEARCHERS
ARE CRAFTING THEIR PROPOSALS FOR
REVIEW AND RATHER THAN HAVING A
VIEW YOU HAVE TO INCENTIVIZE
LIKE THE SECURITY RESPONSIVE
BEHAVIOR, I THINK THE DESIRE TO
DO THAT IS ALREADY THERE.
AND THE WAY THAT SCIENTISTS
WRITE OUR APPLICATIONS OF COURSE
SPEAKING AS A JUNIOR FACULTY
BUSY WRITING APPLICATIONS ALL
THE TIME, WHAT WE PROPOSE IS IN
DIRECT RESPONSE TO THE
EXPECTATIONS FROM THE REVIEW
PANEL.
I DON'T THINK IT WOULD -- I
THINK IT'S A MATTER OF BALANCING
WHAT IS REQUIRED IN THE
APPLICATION AS LONG AS YOU DON'T
ATTEMPT TO JUST ADD BIO SECURITY
ON TOP OF EVERYTHING ELSE.
TO BE FRANK THERE ARE FEATURES
AND THINGS THAT ARE ASKED IN A
STANDARD APPLICATION THAT DON'T
REALLY MAKE THE SCIENCE ANY
BETTER AND CAN BE REMOVED OR
REPLACED SO THERE'S MORE THINGS
THAT WOULD HAVE A POSITIVE
IMPACT ON THE SCIENCE BEING DONE
AND HOW IT'S REVIEWED.
I WANTED TO MAKE THAT COMMENT TO
CHALLENGE THE IDEA THAT GETTING
SCIENTIST TO SPEAK ON VIRAL
SECURITY AND WOULD BE A MATTER
OF THE BEHAVIOR.
IT'S JUST WHAT THE REVIEW
PANEL'S ASKING FOR.
THE DIFFERENCE AND QUALITY OF
PROPOSAL HAS BEEN VSTRIKING LAS
FIVE YEARS.
AND THE MOMENT IS CONSTRUCTIVE.
IT'S GREAT TO HEAR THERE IS MORE
ATTENTION TO ON THE PART OF THE
RESEARCHERS.
I THINK IT'S ANOTHER STATEMENT
OF THE EXPANSION OF THE BREADTH
OF THE RESEARCH CYCLE THAT NEEDS
TO HAVE THE KIND OF ATTENTION TO
SECURITY CONCERNS.
IT'S NOT JUST THE P.I. WHICH IS
WHERE SO MUCH OF THE ATTENTION
OF THE POLICIES ARE IN PLACE.
>> WELL, WE'RE IN TIME AND I
WANT TO THANK OUR SPEAKERS THIS
AFTERNOON, YOU PROVIDED THE
THOUGHT PROVOKING AFTERNOON.
IT'S BEEN -- I THINK YOU MADE
OUR CHALLENGES HARDER BUT I'VE
ALSO HEARD SOME OPPORTUNITIES.
I THINK PART OF OUR JOB NOW IS
TO TRY TO FIGURE OUT THE
OPPORTUNITIES AS WE THINK ABOUT
HOW WE BALANCE THE SECURITY AND
SAFETY CONCERNS WHILE ENABLING
THE LIVE SCIENCE TO CONTINUE TO
INNOVATE AND SOMEHOW AS A
COMMUNITY WE HAVE TO DO THAT BUT
WE HAVE TO ADDRESS SOME OF THE
HARD POLICY ISSUES AND OVERCOME
SOME OF THE CHALLENGES.
I'M ALWAYS -- OPTIMISTIC WITH
THE OPPORTUNITIES YOU BROUGHT
FORWARD AND WE'LL CONTINUE TO
TAKE YOUR INPUT.
THANK YOU VERY MUCH.
I WANT TO THANK THE PEOPLE THAT
TOOK THE TIME TO SPEAK TO US
FROM THE PUBLIC COMMENTS
VERBALLY AND ALSO SUBMITTED
WRITTEN PUBLIC COMMENTS AND THE
NSABB WILL TAKE ALL THAT
INFORMATION IN AS WE CONTINUE TO
LOOK AT THE P3CO AND DURC
WORKING GROUPS CONTINUE TO WORK
ON THIS AND AT SOME POINT WE'LL
COME TOGETHER AS A FINAL
FINDINGS AND RECOMMENDATIONS OF
THE ENTIRE BOARD AS WE CONTINUE
TO WORK ON THESE THE NEXT
SEVERAL MONTHS.
WITH THAT BACK FOR LAST-MINUTE
THOUGHTS.
>> THANK YOU, FOR YOUR
LEADERSHIP OF THIS GROUP.
WE ARE GREATLY APPRECIATIVE OF
YOUR WORK.
I AM THRILLED TO SAY YOU ALL
JOINED US TODAY AND HEARD
IMPORTANT CONVERSATIONS AND
REFLECTED OFTEN SOME OF THE
CONCEPTS DISCUSSED TODAY THAT
ARE MEANING IT WILL TO US
ESPECIALLY AS POLICY MAKER S.
I WANTED TO EMPHASIZE FRAMEWORK
CAPABLE OF ANTICIPATING THE PACE
OF TECHNOLOGY IS A CHALLENGE AND
ONE WE HOPE TO ADDRESS HERE.
OUR GOAL IS TO THINK HOW TO
CREATE THE POLICY TO ALLOW THE
RESEARCH TO PROVIDE SWIFTLY BUT
THE APPROPRIATE GUARDRAILS IN
PLACE TO HAVE CONSISTENCY AND
NOT HAVE THE FITS AND STOPS.
WHAT'S IMPORTANT TO US AND WHAT
WE THOUGHT IS HOW TO INCENTIVIZE
THIS CULTURE OF RESPONSIBILITY
AND COMPLIANCE IS NEEDED BUT OF
COURSE DRIVEN BY ESTABLISHED
INCENTIVES THAT ARE NEEDED TO
INITIATE AND SUSTAIN LONG-TERM
CHANGE.
THIS IS THE AREA WHERE YOU ALL
HERE TODAY AND NSABB CAN PROVE
TO BE AN AGENT FOR CHANGE ACROSS
SECTORS AND DISCIPLINES AND
HAVING THE COORDINATED WHOLISTIC
APPROACH.
THANK YOU FOR TAKING THE TIME TO
JOIN US AND ALL YOUR INPUT IS
EXTREMELY VALUABLE TO THE WORK
WE'LL BE DOING AND CONTINUE TO
DO AND THANK YOU AGAIN TO THE
MEMBERS WHO CONTINUE TO DEVOTE
AN EXTRAORDINARY TIME ON TOP OF
OTHER DUTIES TO HAVE A
DELIBERATIVE PROCESS.
THANK YOU, DR. PARKER.
>> THANK YOU FOR YOUR CLOSING
REMARKS AND TO THANK THE MEMBERS
AND I LOOK FORWARD CONTINUING TO
WORK HARD WITH YOU OVER THE NEXT
SEVERAL MONTHS AS WE GRAPPLE
WITH THESE ISSUES.
WITH THAT, THIS MEETING OF THE
NSABB IS ADJOURNED.
THANK YOU.