GOOD AFTERNOON. I'M GERALD PARKER, CHAIR, I'D LIKE TO WELCOME YOU TO TODAY'S MEETING. I'D LIKE TO START BY EXTENDING A WARM WELCOME TO MY FELLOW NSABB MEMBERS, I'M GOING TO USE THAT ACRONYM FOR NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY. IN PARTICULAR, THE NEW MEMBERS OF THE BOARD OF WHICH I AM ALSO A NEW MEMBER. I LOOK FORWARD TO WORKING WITH YOU TO BUILD ON THE NSABB'S HISTORY AND ACCOMPLISHMENTS, GREAT OPPORTUNITY TO COLLEAGUES WHO I CROSSED PATHS WITH AND WORKED WITH OVER THE YEARS AND LOOK FORWARD TO WORKING WITH YOU ON THESE VERY COMPLEX ISSUES AND LOOK FORWARD TO MEETING NEW COLLEAGUES AND SIMILARLY WORKING WITH YOU ON THESE COMPLEX ISSUES. BEFORE WE GO AROUND THE TABLE FOR MEMBER INTRODUCTIONS, I'D ALSO LIKE TO THANK THE INVITED MEETING PARTICIPANTS FOR TAKING TIME TO BE HERE. AND I KNOW IT'S EXTREMELY DIFFICULT FOR EVERYBODY TO TAKE TIME AWAY FROM WORK TO JOIN US SO WE'RE VERY THANKFUL YOU'RE ABLE TO DO THAT. I'M SURE I SPEAK FOR THE ENTIRE% BOARD WHEN WE SAY WE APPRECIATE YOUR VALUE AND YOUR EXPERT OPINIONS. I'D LIKE TO ACKNOWLEDGE THOSE PARTICIPATING IN PERSON AND REMOTELY. YOUR PARTICIPATION IN THE NSABB PUBLIC MEETINGS AND COMMENTS AND VIA E-MAIL TO THE BOARD ARE AN ESSENTIAL PART OF WHAT WE DO, TO PROVIDE AS REQUESTED ADVICE, GUIDANCE, LEADERSHIP REGARDING BIOSECURITY OVERSIGHT OF DUAL USE RESEARCH. THAT IS BIOLOGICAL RESEARCH FOR LEGITIMATE SCIENTIFIC PURPOSES THAT MAY BE MISUSED TO POSE A BIOLOGICAL THREAT TO PUBLIC HEALTH AND/OR NATIONAL SECURITY. THE NSABB HAS BEEN A LEADER REGARDING OVERSIGHT OF DUAL USE RESEARCH OF CONCERN, OR DURC, AND GAIN OF FUNCTION WE SEARCH AND BOARD'S RECOMMENDATIONS HAVE BEEN KEY INPUT TO DEVELOPMENT OF POLICIES WE'LL BE DISCUSSING TODAY. TODAY WE WILL RECEIVE A NEW CHARGE. IT RELATES TO THESE ISSUES. I'M CONFIDENT THAT THE BOARD WILL CONTINUE TO BE A SOURCE OF VERY THOUGHTFUL AND SOUND ADVICE TO U.S. GOVERNMENT. TURNING TO OUR AGENDA FOR THE AFTERNOON, SESSION 1, WE'LL HEAR A BRIEF OVERVIEW AND UPDATE OF THE DUAL USE RESEARCH CONCERN, GAIN-OF-FUNCTION ISSUE, AND CURRENT POLICY LANDSCAPE FOLLOWED BY PRESENTATION OF CHARGE TO THE COMMITTEE. SESSION 2 WE'LL FOCUS ON THE ISSUES AND TRANSPARENCY AND SECURITY IN RESEARCH. WE HAVE ARRAY OF PRESENTERS AND PANELISTS PROVIDING INPUT ON ISSUES THAT SHOULD BE CONSIDERED. WE WILL CLOSE WITH A BOARD DISCUSSION ABOUT WHAT WE HAVE HEARD AND LIKELY WHAT WE WOULD LIKE TO HEAR MORE ABOUT WHEN WE MOVE FORWARD. NOW I'D LIKE TO MOVE TO THE INTRODUCTION OF THE NSABB VOTING MEMBERS. I WILL ASK MEMBERS TO BRIEFLY INTRODUCE YOURSELF. REALLY JUST YOUR NAME AND AFFILIATION, AND I ENCOURAGE EVERYBODY THAT'S PARTICIPATING, BOARD MEMBERS AND EVERYBODY IN THE AUDIENCE AND THOSE LISTENING IN, TO READ THE BIOS OF OUR BOARD MEMBERS. IT'S AN EXTRAORDINARY BOARD PULLED TOGETHER TO TACKLE THESE COMPLEX ISSUES SO PLEASE, EVERYBODY, PLEASE READ EVERYBODY'S BIOS. IT REALLY IS EXTRAORDINARY EXPERTISE THAT'S BEEN BROUGHT TO BEAR TO THINK ABOUT AND DELIBERATE THESE ISSUES. SO I'LL KICK OFF INTRODUCTIONS. I'M GERRY PARKER, ASSOCIATE DEAN FOR GLOBAL ONE HEALTH. >> YOU ARE THE ONLY PARTICIPANT IN THE CONFERENCE. [LAUGHTER] >> DOESN'T LOOK LIKE IT. [LAUGHTER] I'LL TRY THAT AGAIN. THAT WAS AN EXTRAORDINARY TIMING. DID YOU PLAN THIS? [LAUGHTER] SO AGAIN I'M GERRY PARKER, ASSOCIATE DEAN FOR GLOBAL ONE HEALTH, COLLEGE OF VETERINARY MEDICAL AND OF AT TEXAS A & M UNIVERSITY, AND BUSH SCHOOL OF GOVERNMENT AND PUBLIC SERVICE, SO WE WILL GO TO MY RIGHT FOR BOARD INTRODUCTIONS. KEN? >> KEN BERNARD. SORRY. KEN BERNARD, LAST JOB IN GOVERNMENT I WAS SPECIAL ASSISTANT TO PRESIDENT FOR BIODEFENSE AT THE WHITE HOUSE, I'VE HAD A VARIETY OF JOBS OVER MANY YEARS, MOSTLY DEALING WITH BIODEFENSE AND BIOSECURITY ISSUES. I'M ALSO PERSON WHO WROTE THE ORIGINAL CHARTER FOR THE NSABB AND THE IMPOSSIBLE FOR ME TO REMEMBER TITLE NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY, THOUGHT UP ONE LATE NIGHT, INTERESTING HAVING NEVER BEEN ON THE PANEL TO NOW BE PART OF IT AND PICK UP WHERE SO MANY GOOD PEOPLE HAVE DONE GOOD WORK PRIOR TO ME. THANK YOU. >> JACKIE FLETCHER, UNTIL RECENTLY I WAS REGENTS PROFESSOR, NATIONAL INSTITUTE FOR MICROBIAL FORENSICS, OKLAHOMA STATE UNIVERSITY, NOW EMERITUS, THREE-QUARTER CONSULTANT IN VARIETY OF ACTIVITIES. >> JOHN GRABENSTEIN, PHARMACIST, EPIDEMIOLOGIST, ARMY VETERAN, UNTIL THREE WEEKS AGO, I JUST RECENTLY RETIRED FROM VACCINES, NOW GETTING READY TO WORK WITH IMMUNIZATION ACTION COALITION. >> GOOD AFTERNOON, STEVE MORRIS, PROFESSOR OF EPIDEMIOLOGY, COLUMBIA UNIVERSITY, INFECTIOUS DISEASE EPIDEMIOLOGIST, AND VIROLOGIST. >> I'M ROZANNE SANDRI-GOLDIN, UNIVERSITY OF CALIFORNIA IRVINE, MOLECULAR GENETIC DEPARTMENT, EDITOR IN CHIEF JOURNAL OF VIROLOGY. >> I'M MARIE-LOUISE HAMMARSKJOLD, PROFESSOR OF MICROBIOLOGY IMMUNOLOGY AND CANCER BIOLOGY, ASSOCIATE DIRECTOR OF THE CENTER AT THE UNIVERSITY OF VIRGINIA, SCHOOL OF MEDICINE, AND I'M MOLECULAR VIROLOGIST BY TRAINING, AND HAVE BEEN INTERESTED IN THESE ISSUES FOR A LONG TIME, SAFETY COMMITTEE FOR MANY YEARS, AND I AM ONE OF THE OLDER MEMBERS OF THIS IN AGE AND FUNCTION OF THIS NSABB. >> I'M PAMELA SILVER, NEW MEMBER, PROFESSOR OF SYSTEMS BIOLOGY AT HARVARD MEDICAL SCHOOL, MEMBER OF THE INSTITUTE AT HARVARD UNIVERSITY, RUN A LARGE RESEARCH GROUP THAT'S FOCUSED ON SYNTHETIC BIOLOGY. I WAS PART OF WRITING THE ROAD MAP FOR SYNTHETIC BIOLOGY AND ALSO I'M ON THE BOARD OF IgEM. >> I'M JEAN PATTERSON, VIROLOGIST, PROFESSOR AT TEXAS BIOMEDICAL RESEARCH INSTITUTE, I WORK IN EMERGING VIRUSES. >> JIM LE DUC, DIRECTOR OF GALVESTON NATIONAL LABORATORY, UNIVERSITY OF TEXAS MEDICAL BRANCH, GALVESTON, PREVIOUSLY WAS AT CDC, WORLD HEALTH ORGANIZATION, AND THE ARMY. >> MARK DENISON, PROFESSOR OF PEDIATRICS, MICROBIOLOGY AND IMMUNOLOGY AT VANDERBILT UNIVERSITY, WHERE I'VE BEEN SINCE 1991, I'VE WORKED ON CORONAVIRUSES SINCE 1984, AND REPLICATION PATHOGENESIS EVOLUTION, VIRUS HOST SPECIES, SWITCHING, AND ANTI-VIRALS. >> NANCY CONNELL, SENIOR SCHOLAR, JOHNS HOPKINS CENTER FOR HEALTH SECURITY, PROFESSOR OF ENVIRONMENTAL HEALTH AND ENGINEERING AT HOPKINS SCHOOL OF PUBLIC HEALTH, EXPERTISE IN BACTERIAL GENETICS AND BIOLOGICAL WEAPONS ARMS CONTROL. >> JESSICA TUCKER, DESIGNATED FEDERAL OFFICIAL, EXECUTIVE SECRETARY OF NSABB. >> DO WE HAVE ANY MEMBERS, NSABB MEMBERS ON THE PHONE? I GUESS THE ANSWER IS NO. SO WE WILL CONTINUE. I WILL ASK AGAIN LATER ON TOO BECAUSE SOMEBODY MAY JOIN LATE. SO THANK YOU. NOW I'M GOING TO TURN THE AGENDA OVER TO DR. JESSICA TUCKER, DESIGNATED FEDERAL OFFICIAL, TO THE NSABB, TO REVIEW CONFLICT OF INTEREST POLICY. JESSICA? >> THANK YOU. TO REMIND YOU OF RULES OF CONDUCT, CONFLICT OF INTEREST. YOU HAVE A SPECIAL GOVERNMENT EMPLOYEE, THEREFORE SUBJECT TO RULES OF CONDUCT THAT APPLY TO GOVERNMENT EMPLOYEES. THE RULES AND REGULATIONS ARE EXPLAINED IN THE REPORT, STANDARDS OF CONDUCT FOR EMPLOYEES OF THE EXECUTIVE BRANCH. YOU EACH RECEIVED THIS DOCUMENT WHEN APPOINTED TO THE COMMITTEE. AT EVERY MEETING IN ADDITION TO REMINDING YOU ABOUT THE IMPORTANCE OF FOLLOWING RULES WE LIKE TO REVIEW STEPS AND ASK YOU TO TAKE TO ENSURE THAT ANY CONFLICTS OF INTEREST ARE ADDRESSED. YOU PROVIDE US WITH INFORMATION ABOUT PERSONAL, PROFESSIONAL AND FINANCIAL INTERESTS, WE USE THIS INFORMATION AS BASIS FOR ASSESSING WHETHER YOU HAVE ANY REAL, POTENTIAL OR APPARENT CONFLICT OF INTEREST, THAT COULD COMPROMISE ABILITY TO BE OBJECTIVE AND GIVING ADVICE. WE WAIVE CONFLICTS INTEREST FOR GENERAL MATTERS, BECAUSE WE BELIEVE YOUR ABILITY TO BE OBJECTIVE WILL NOT BE AFFECTED BY YOUR INTEREST IN SUCH MATTERS, WE ALSO RELY TO A GREAT DEGREE ON YOU TO BE ATTENTIVE IN MEETINGS, TO THE POSSIBILITY AN ISSUE COULD AFFECT OR APPEAR TO AFFECT YOUR INTEREST IN SPECIFIC WAY WE ASK YOU TO RECUSE YOURSELF FROM THE DISCUSSION AND LEAVE THE ROOM IF THIS HAPPENS. IF YOU HAVE ANY QUESTIONS ABOUT RULES OF CONDUCT OR CONFLICT OF INTEREST, OUR COMMITTEE MANAGEMENT OFFICER LISA NEIL WILL BE HAPPY TO ADDRESS THEM. THANKS. >> THANK YOU, JESSICA. BEFORE OUR FIRST PRESENTATION, I WANT TO PROVIDE ANNOUNCEMENTS AND LET PRESENTERS KNOW THAT OUR SESSIONS WILL BE TIMED. YOU'VE BEEN GIVEN AN ALLOTTED TIME. THERE'S A TIMER. AS TYPICAL WITH THESE MEETINGS, GREENS MEANS GO, RED MEANS STOP. WE WILL HAVE THE OPPORTUNITY AND WE ENCOURAGE PUBLIC COMMENTS, THE OPPORTUNITY FOR PUBLIC COMMENTS THAT COMES ON THE AGENDA TOMORROW. MEMBERS OF THE PUBLIC WHO WISH TO EXPRESS VIEWS REGARD ANY ITEMS DISCUSSED IN THE MEETING MAY DO SO BY WRITING DR. TUCKER, THE FEDERAL OFFICIAL, WITHIN TEN DAYS OF THE MEETING. ANY WRITTEN STATEMENTS BY MEMBERS OF THE PUBLIC WILL RECEIVE CAREFUL CONSIDERATION BY THE NSABB BOARD. AFTER EACH OF THE UPCOMING PRESENTATIONS WE WILL HOPEFULLY HAVE A FEW MINUTES AT THE END TO TAKE A COUPLE QUESTIONS FROM NSABB BOARD MEMBERS. WITH THAT, I WOULD LIKE TO WELCOME DR. CARRIE WOLINETZ, ACTING CHIEF OF STAFF AND ASSOCIATE DIRECTOR FOR SCIENCE POLICY, NATIONAL INSTITUTES OF HEALTH, TO GET US STARTED BY PROVIDING UPDATES ON THE POLICY LANDSCAPE REGARDING DIRK AND GAIN-OF-FUNCTION RESEARCH. >> WELL, THANK YOU VERY MUCH. IT'S A PLEASURE TO BE HERE TODAY AND SEE SO MANY FAMILIAR SAYSES AND NEW ONES AS WELL. I'M GOING TO WALK YOU THROUGH NOW I SUPPOSE IN THE ROLES OF THE GHOST OF CHRISTMAS PAST AND CHRISTMAS PRESENT WITH MY COLLEAGUE FROM ASPR, AND LATER AS THE GHOST OF CHRISTMAS FUTURE WHEN IT COMES TO THE NSA ABOUT,B. SO, I THINK IT'S IMPORTANT TO JUST START WITH SOME BASIC PRINCE PELTS HERE. -- PRINCIPLES HERE, ALL ABOUT PROMOTING SECURITY THROUGH SUPPORT OF LIFE SCIENCE RESEARCH. WE CAN ALL AGREE A ROBUST RESEARCH ENTERPRISE IS CRITICAL BOTH TO PROMOTING PUBLIC HEALTH AND WELL-BEING, AND THAT IS PARTICULARLY TRUE IN THE AREA OF EXPERTISE THAT MANY OF YOU BRING TO THE TABLE TODAY, INVOLVING THREATS POSED BY MICROBIAL PATHOGENS. THE U.S. GOVERNMENT SUPPORTS A DIVERSE LIFE SCIENCES RESEARCH PORTFOLIO OF WHICH NIH IS OF COURSE JUST ONE PART. RESEARCH INVOLVING POTENTIALLY DANGEROUS PATHOGENS HAS INHERENT BIOSAFETY AND BIOSECURITY RISKS, I KNOW THAT'S NOT NEW NEWS, WHAT THE NSABB HAS BEEN DISCUSSING, SINCE IT WAS A TWINKLE IN KEN'S EYE, HOW DO WE FACILITATE BENEFICIAL BIOLOGICAL RESEARCH WHILE MITIGATING THE POTENTIAL RISKS OF MISUSE. IT'S IMPORTANT TO RECOGNIZE TO REALIZE BENEFITS OF RESEARCH INVOLVING PATHOGENS YOU'RE GOING TO REQUIRE RISK ASSESSMENT AND MITIGATION AND POLICIES, PRACTICES, OVERSIGHTS. THIS IS WHAT I'M GOING TO GIVE A QUICK OVERVIEW OF TODAY. GUIDANCE, AND OTHER PROCEDURES AT THE FEDERAL AND LOCAL LEVEL IS COMPLEX, EVOLVED SUBSTANTIALLY OVER THE PAST 10 TO 20 YEARS, INCLUDES OCCUPATIONAL HEALTH AND SAFETY REGULATIONS AND STANDARDS, THE BIOSAFETY AND MICROBIOLOGY AND BIOMEDICAL LABORATORIES, SO THE BIBLE OF MICRO BIOSAFETY IN MANY WAYS, THE NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT OR SYNTHETIC MOLECULES, SELECT AGENT REGULATIONS, WE'LL HEAR MORE IN THE COURSE OF THE MEETING, SCREENING FRAMEWORK GUIDANCE FOR DOUBLE-STRANDED DNA, DUAL USE RESEARCH OF CONCERNS, DURC POLICIES AND CARE AND OVERSIGHT, THE U.S. GOVERNMENT'S POLICY AND HHS FRAMEWORK. DUAL USE RESEARCH OF CONCERN HAS BEEN THE PRIMARY TOPIC OF CONVERSATION OF THE NSABB OVER THESE NUMBER OF YEARS. AND HOPEFULLY AS SUCH YOU'VE RECOGNIZED THESE DEFINITIONS, DUAL USE RESEARCH, LIFE SCIENCE RESEARCH THAT HAS POTENTIAL TO BE UTILIZED FOR BENEVOLENT AND HARMFUL PURPOSES. ADDITIONAL LAYER, DUAL USE RESEARCH OF CONCERN, SO SUBSET OF THAT RESEARCH WHICH HAS GREATEST POTENTIAL TO GENERATE KNOWLEDGE, INFORMATION OR PRODUCTS, COULD BE READILY MISUSED TO POSE SIGNIFICANT THREATS TO PUBLIC HEALTH AND NATIONAL SECURITY. SO U.S. GOVERNMENT HAS POLICIES IN PLACE THAT ARE PUT FORWARD TO CREATE OVERSIGHT OF DUAL USE RESEARCH OF CONCERN. THESE POLICIES ARE AIMING TO ACHIEVE THAT BALANCE THAT I MENTIONED EARLIER, PRESERVING BENEFITS OF LIFE SCIENCE RESEARCH, MINIMIZING RISK OF MISUSE OF THE INFORMATION PRODUCTS OR TECHNOLOGIES GENERATED BY SUCH RESEARCH. THERE IS BOTH AN OVERARCHING U.S. GOVERNMENT POLICY WHICH IS REALLY FOR FEDERAL AGENCIES TO IMPLEMENT, IT REQUIRES FEDERAL FUNDING AGENCIES TO IDENTIFY DURC AS DEFINED BY SCOPE OF POLICY IN RESEARCH PORTFOLIOS AND WORK TO MITIGATE RISK OF SUCH RESEARCH AS NEEDED. AND THEN THERE'S ALSO AN INSTITUTIONAL PIECE AS WELL, IN WHICH FEDERALLY FUNDED RESEARCH INSTITUTIONS HAVE TO ESTABLISH REVIEW SYSTEM TO IDENTIFY DURC AND WORK WITH FUNDING AGENCIES AGAIN ON RISK MITIGATION, A COOPERATIVE RELATIONSHIP. THE PURPOSE OF THOSE POLICIES AND PRINCIPLES ON WHICH THEY REST OF COURSE ARE TO ACHIEVE THIS BALANCE OF ALLOWING THE BENEFITS OF THE RESEARCH TO GO FORWARD, WHILE MITIGATING POTENTIAL RISK OF MISUSE, AND ARE REALLY PREDICATED ON A NUMBER OF PRINCIPLES WHICH I THINK IT'S IMPORTANT TO NOTE ARE VERY MUCH BASED ON THE DISCUSSIONS OF THE NSABB OVER THE YEARS AND A NUMBER OF REPORTS ON THIS TOPIC THAT THE NSABB PUT FORWARD. FREE AND OPEN CONDUCT AND COMMUNICATION IS VITAL TO ROBUST SCIENTIFIC ENTERPRISE, RELYING ON THE EDUCATIONAL COMMUNITY ABOUT DUAL USE POTENTIAL OF LIFE SCIENCES RESEARCH, A LOT OF FOCUS WE'VE HAD THROUGH THE YEARS ON AWARENESS AND EDUCATION OF THE COMMUNITY ITSELF. THAT INSTITUTIONS AND INVESTIGATORS ARE THE FRONT LINE OF IDENTIFYING AND SUGGESTING STRATEGIES FOR DUAL USE RESEARCH, CONDUCT AND COMMUNICATION, TO ACHIEVE THAT BALANCE BETWEEN BENEFITS AND RISK, AND THAT ULTIMATELY EFFECTIVE OVERSIGHT HELPS BUILD AND MAINTAIN PUBLIC TRUST IN THE LIFE SCIENCE RESEARCH ENTERPRISE, IMPORTANT FOR OUR SUCCESS. AND WE SEE THIS OF COURSE, AND THIS IS, AGAIN, BASED ON THE WORK AND EXPERTISE OF THE NSABB THROUGH THE YEARS AS A COOPERATIVE AND COLLABORATIVE VENTURE BETWEEN THE FEDERAL GOVERNMENT AND THE INSTITUTIONS WHO WE FUND THROUGH OUR FEDERAL RESEARCH AGENCIES AND THIS IS REALLY AN OVERSIGHT PROCESS THAT IS IMPORTANT THROUGHOUT THE LIFE CYCLE OF THE RESEARCH FOR -- STARTING WITH PROJECT CONCEPTUALIZATION AND SOLICITATION, CONSIDERATION, BY THE FUNDING AGENCIES RELATED TO FUNDING DECISIONS, THE CONDUCT OF THE RESEARCH ITSELF, AND THEN ULTIMATELY THE COMMUNICATION OF THE RESEARCH. THERE ARE OPPORTUNITIES FOR OVERSIGHT AND DIALOGUE THROUGHOUT THE ENTIRE PROCESS. SO SWITCHING NOW TO GAIN-OF-FUNCTION RESEARCH, I THINK IT'S IMPORTANT AGAIN TO SET SOME DEFINITIONAL GUIDELINES AND A LOT COMES OUT OF THE WORK OF NSABB. IT'S AN INARTFUL TERM, COMMONPLACE METHODOLOGY IN THE LIFE SCIENCES, IT'S THE CORNERSTONE OF MOLECULAR BIOLOGY IN MANY WAYS. YOU KNOW, INTRODUCING GENETIC MUTATIONS INTO AN ORGANISM TO SEE WHAT HAPPENS, TO EXAMINE THE RESULTING PHENOTYPE, THAT'S PROVIDED A GREAT DEAL OF KNOWLEDGE IN TERMS OF OUR UNDERSTANDING OF GENETIC INFLUENCES ON PHENOTYPE. BUT REALLY WHAT WE'RE TALKING ABOUT WHERE THE RUBBER HITS THE ROAD IN THIS CONVERSATION IS A SUBSET OF GAIN-OF-FUNCTION STUDIES THAT COULD POTENTIALLY RESULT IN GENERATION OF PATHOGENS WITH PANDEMIC POTENTIAL. SO THESE ARE STUDIES THAT GENERATE PATHOGENS WITH ENHANCED PATHOGENICITIES OR TRANSMISSIBILITY, PARTICULARLY RESPIRATORY DROPLETS IN MAMMALS, OFTEN CITED AS AN EXAMPLE OF DURC, POTENTIALLY PROVIDE BENEFIT BUT ALSO COULD BE MISUSED OR PROVIDE SOME FORM OF RISK, AND OF COURSE THIS HAS LED OVER SEVERAL YEARS TO DEBATE ABOUT THE RISKS AND BENEFITS OF THIS RESEARCH. LET'S DWELL ON THAT FOR A MOMENT. PSOAS DISCUSSED PREVIOUSLY BY THE NSABB SOME POTENTIAL BENEFITS OF THE GAIN-OF-FUNCTION STUDIES TO HELP DEFINE FUNDAMENTAL NATURE OF HUMAN PATHOGEN INTERACTION TO ENABLE ASSESSMENT OF PANDEMIC POTENTIAL OF EMERGING INFECTIOUS DISEASES. THEY HAVE BEEN CRITICAL INVOLVING THE STUDIES OF PATHOGENS THAT COULD BE POTENTIALLY CAUSING PANDEMIC AND HAVE BEEN CRITICAL TO INFORM PUBLIC HEALTH AND PREPAREDNESS EFFORTS, CERTAINLY AVIAN INFLUENZA IS A GOOD EXAMPLE OF PATHOGEN IN WHICH THESE STUDIES CAN BE HELPFUL IN UNDERSTANDING THE EVOLUTION OF THAT VIRUS AS IT MIGHT RELATE TO POTENTIAL EPIDEMIC OR PANDEMIC WHICH IS A CONSTANT THREAT, AND CLEARLY THE RECENT EXAMPLE OF THE NOVEL CORONAVIRUS IS ANOTHER EXAMPLE OF WHY THIS RESEARCH CAN BE INCREDIBLY IMPORTANT. ULTIMATELY HELPS FURTHER MEDICAL COUNTERMEASURE DEVELOPMENT. HOWEVER WE CAN AGREE SUCH RESEARCH DOES HOLD SUBSTANTIAL RISK. IT COULD INVOLVE GENERATING ENGINEERED PATHOGENS THAT COULD POSE PANDEMIC THREAT IF ACCIDENTALLY OR OR INTENTIONALLY RELEASED, THE DUAL USE DILEMMA, AND THAT CERTAINLY IF THERE WERE TO BE MORE LABS GETTING INVOLVED IN THIS AREA OF RESEARCH THAT COULD INCREASE THE RISK LANDSCAPE. SO, IN 2011, 2012 THERE WERE A LOT OF QUESTIONS RAISED RELATED TO RESPIRATORY TRANSMISSION OF HIGHLY PATHOGENIC AVIAN INFLUENZA, RAISED CONCERNS, COVERED IN THE MEDIA, I'M SURE YOU'RE FAMILIAR WITH THIS, AND THIS LED TO THE DEBATES OVER WHETHER AND HOW INFORMATION CONTAINED IN MANUSCRIPTS SHOULD OR COULD BE SHARED AND THE PUBLIC RESPONSE TO THAT RANGED FROM PUBLISH IN FULL, THIS IS IMPORTANT INFORMATION WE HAVE TO GET OUT THERE, TO SOME FORM OF REDACTION, OR REDUCED PUBLICATION, TO CLASSIFICATION OF THE RESEARCH. SO A PRETTY FULL RANGE OF REACTIONS. AND THAT'S PERHAPS CAPTURED IN THE PERSPECTIVES OF TWO GROUPS HIGHLY INVOLVED IN THAT DEBATE, AND WE'VE GOT MEMBERS OF BOTH IN THE ROOM TODAY. CAMBRIDGE WORKING GROUP, WHICH NOTED THAT THE EXPECTED NET BENEFIT SHOULD OUTWEIGH THE RISKS, EXPERIMENTS INVOLVING CREATION OF POTENTIAL PANDEMIC PATHOGENS SHOULD BE CURTAILED UNTIL THERE'S BEEN ASSESSMENT OF THE RISKS SO CAUSING FOR RECONSIDERATION OF THIS SORT OF RESEARCH, TO THE SCIENTISTS FOR SCIENCE WHO WERE MORE ON THE BENEFITS OF OUTWEIGHING RISK SIDE AND REALLY IMPORTANT THAT WE MOVE THIS RESEARCH FORWARD IN AN UNFETTERED WAY AND NOT LIMIT THESE TYPE OF EXPERIMENTS. SO, THIS DEBATE RESULTED IN A DELIBERATIVE PROCESS CONDUCTED BY THE U.S. GOVERNMENT, TO REEVALUATE THE POTENTIAL RISKS AND BENEFITS ASSOCIATED WITH THIS TYPE OF GAIN-OF-FUNCTION RESEARCH INVOLVING PATHOGENS WITH PANDEMIC POTENTIAL, AND IT IS IMPORTANT TO NOTE THAT AT THAT TIME THIS DEBATE WAS ACCOMPANIED BY A RESEARCH FUNDING PAUSE FOR SOME OF THESE LIKELY PATHOGENS, INFLUENZA, MERS AND SARS, SPECIFICALLY WHILE THE PUBLIC DEBATES AND DISCUSSION ABOUT POLICY WENT ON. IT'S PROBABLY IMPORTANT TO NOTE AGAIN JUST FOR THE PURPOSES OF MAKING SURE WE GET THE HISTORY RIGHT HERE, THAT WHEN THAT PAUSE WAS ANNOUNCED, IT WAS OUTLINED AS BEING EFFECTIVE UNTIL ROBUST AND BROAD DELIBERATIVE PROCESS IS COMPLETED THAT RESULTS IN ADOPTION OF NEW U.S. GOVERNMENT GAIN-OF-FUNCTION RESEARCH POLICY. SO THAT DELIBERATIVE PROCESS OF COURSE DID TAKE PLACE. THIS WAS A MULTI-DIMENSIONAL PROCESS OF WHICH THE NSABB SERVED AS SORT OF CENTRAL LOCUS, NATIONAL ACADEMIES WAS INVOLVED, WE COMMISSIONED RISK AND BENEFIT ASSESSMENTS, A LITTLE LIGHT SUMMER READING OF APPROXIMATELY 2,000 PAGES, IF ANYONE HAS A CHANCE TO CATCH UP ON THAT. I'D BE HAPPY TO LOAN YOU MY COPY. ETHICS, ANALYSIS, AND OF COURSE A NUMBER OF MEETINGS OF THE NSABB ITSELF TO DISCUSS THIS, ALL OF THIS WAS OPEN TO THE PUBLIC SO IT WAS HIGHLY TRANSPARENT, TOOK PLACE OVER A COUPLE YEARS, AND THIS ULTIMATELY FED INTO THE U.S. GOVERNMENT GAIN-OF-FUNCTION POLICY PROCESS. THE PROCESS WAS TRANSPARENT AND WE WORKED HARD TO GAIN MAXIMAL STAKEHOLDER INPUT. WE HAD EIGHT PUBLIC MEETINGS, SIX SPONSORED BY NSABB, TWO AT NATIONAL ACADEMIES, A HUNDRED INVITED SPEAKERS, PANELISTS, PRESENTERS, MANY IN THE ROOM RIGHT NOW SO THANK YOU FOR YOUR INPUT. 50 EXPERTS INTERVIEWED FOR RISK/BENEFIT ASSESSMENT, CONDUCTED BY GRIFFIN SCIENTIFIC. WE GOT 50 PUBLIC COMMENTERS, WRITTEN AND ORAL. THERE WAS A LOT OF INPUT INTO THIS TRANSPARENT PROCESS. THE NSABB TOOK IN ALL OF THIS INPUT, EVERYTHING I THINK THEY READ FRONT TO BACK, THE 2,000-PAGE REPORT, ALL OF THE PUBLIC COMMENTS AND ALL OF THE PRESENTATIONS, AND ULTIMATELY WORKED TO DEVELOP RECOMMENDATIONS RELATED TO EVALUATION AND OVERSIGHT OF GAIN-OF-FUNCTION RESEARCH INVOLVING PATHOGENS WITH PANDEMIC POTENTIAL AND THAT REPORT IS FREELY AVAILABLE ON THE NIH WEBSITE. AND IN A NUTSHELL, WHAT THE NSABB FOUND IS IN FACT THAT THESE SORTS OF STUDIES, THIS SUBSET OF GAIN-OF-FUNCTION STUDIES, IN WHICH PATHOGENS WERE PANDEMIC POTENTIAL COULD POTENTIALLY BE ENHANCED, DOES HAVE POTENTIAL PUBLIC HEALTH BENEFITS, SO THEY WEIGHED IN IT WAS IMPORTANT TO DO THIS RESEARCH BUT ALSO NOTED SIGNIFICANT POTENTIAL RISKS AND THOUGHT RISKS IN FACT MERITED ADDITIONAL LEVEL OF REVIEW FOR THIS TYPE OF RESEARCH, SPECIFICALLY SO THEY RECOMMENDED AN ADDITIONAL MULTI-DISCIPLINARY DEPARTMENT-LEVEL EVALUATION, PRIOR TO FUNDING DECISION, AND THEN APPROPRIATE ONGOING OVERSIGHT IF FUNDED. SO THAT WAS TAKEN OF COURSE INTO THE GOVERNMENT POLICY-MAKING PROCESS, AND IN JANUARY OF 2017 THE OFFICE OF SCIENCE AND TECHNOLOGY POLICY RELEASED POLICY GUIDANCE RELATED TO REVIEW MECHANISMS FOR THESE SORTS OF EXPERIMENTS. IMPORTANTLY, THEY STUCK WITH THE NSABB DEFINITION OF A POTENTIAL PANDEMIC PATHOGEN, ONE THAT IS LIKELY HIGHLY TRANSMISSIBLE AND CAPABLE OF WIDE AND UNCONTROLLABLE SPREAD IN THE HUMAN POPULATION, LIKELY VIRULENT, CAUSING MORTALITY AND MORBIDITY IN HUMANS, ENHANCED PPP, PATHOGEN PANDEMIC POTENTIAL, NOT WHAT WE FIND IN NATURE BUT MANIPULATED IN THE LABS IN SOME WAY TO INCREASE PATHOGENS' TRANSMISSIBILITY OR VIRULENCE. THE OSTP POLICY RESULTED IN RESPONSE FROM THE DEPARTMENT OF HEALTH AND HUMAN SERVICES, I WON'T DWELL ON THIS BECAUSE MY COLLEAGUE WILL TALK ABOUT IT EXTENSIVELY, BUT IN DECEMBER OF 2017 HHS PUT OUT A FRAMEWORK FOR GUIDING FUNDING DECISIONS RELATED TO THIS, AND IN FACT FULFILLING THE OSTB MANDATE TO ESTABLISH MULTI-DISCIPLINARY DEPARTMENT-LEVEL REVIEW. THIS IS INTENDED TO GUIDE HHS FUNDING DECISIONS ON INDIVIDUAL PROPOSED RESEARCH, REASONABLY ANTICIPATED TO CREATE TRANSFER OR USE THESE PATHOGENS, AND, AGAIN, SEEKING TO FULFILL THAT PRINCIPLE OF BALANCE. SO WHEN THIS FRAMEWORK IS ANNOUNCED, JUST TO AGAIN REMIND YOU ALL OF THE HISTORY THAT WE ALL LIVED THROUGH TOGETHER, WHEN THE ADOPTION OF THIS FRAMEWORK WAS ANNOUNCED, WE ALSO ANNOUNCED A LISTING OF THE PAUSE, AGAIN IN LINE WITH WHAT WE SAID ABOUT THE PAUSE IN THE FIRST PLACE THAT AS SOON AS WE HAD A POLICY IN PLACE WE WERE GOING TO MOVE FORWARD, AND THIS WAS PRETTY WELL COVERED IN THE NEWS. THERE WERE A LOT OF STATEMENTS BOTH FROM HHS AND NIH ABOUT THIS. AND IN FACT THAT IS IN FACT WHAT WE DID, ONCE THAT PAUSE WAS LIFTED, IT WAS SORT OF BUSINESS AS USUAL, WITH THIS ADDITIONAL LEVEL OF REVIEW PUT IN PLACE AS PART OF THE FUNDING PROCESS. SO, WITH THAT I'M GOING TO STOP TALKING BEFORE I GOT TO THE RED LIGHT, I MIGHT NOTE. AND REFER YOU TO THESE ADDITIONAL RESOURCES WHICH I'VE REFERRED TO THROUGHOUT THE PRESENTATION, WHICH PROVIDES ADDITIONAL INFORMATION ON ALL OF THESE PROCESSES, PROCEDURES, AND POLICY DEVELOPMENT PROCESS. AND I'M HAPPY TO TAKE ANY QUESTIONS. >> THANK YOU FOR THE PRESENTATION. I'D LIKE TO OPEN TO QUESTIONS FROM THE BOARD MEMBERS. >> THAT WAS GOOD. CATCHES ME UP AS WELL. I WANT TO GO BACK A LITTLE BIT, FOR SOME THAT WEREN'T AROUND IN 2004 WHEN THE ORIGINAL THING WAS -- THIS WAS ORIGINALLY CREATED, TO SAY THAT THE ORIGIN OF THE NSABB CAME FROM A REACTION TO THE THINK REPORT WHICH EVERYBODY IN THIS ROOM SHOULD HAVE AT LEAST SEEN IN PASSING, WAS DONE IN 2003. I FORGET THE TITLE OF THAT ONE TOO. BUT IT'S USUALLY REFERRED TO AS THE FINK REPORT WHICH -- >> BIOLOGICAL RESEARCH IN AN AGE OF TERRORISM. >> THANK YOU, CARRIE. AND IT HAD THESE SEVEN CATEGORIES OF DANGEROUS WORK THAT COULD POTENTIALLY BE USED IN A TERRORIST EVENT OR BY BAD PEOPLE, CALLED THE SEVEN DEADLY SINCE AS YOU MIGHT RECALL. THE PROBLEM WITH THE REPORT AS WAS SEEN, I WAS AT THE WHITE HOUSE AT THE TIME, THAT WAS SEEN BY US WAS NOT THAT IT DIDN'T OUTLINE THE DANGERS BUT IT MIGHT HAVE RESTRICTED RESEARCH. AND SO INTERESTINGLY ENOUGH, THE NSABB WAS NOT CREATED TO GUARD AGAINST SO MUCH THE BAD USE OF RESEARCH BUT TO MAKE SURE THAT THE SEVEN DEADLY SINS DID NOT BECOME THE STANDARD AGAINST WHAT ALL RESEARCH WAS MEASURED AGAINST. IT IS THE REVERSE OF GOVERNMENT CONTROL OF RESEARCH. PEOPLE FORGET THAT THE INTENTION WAS TO ALLOW DELIBERATIVE PROCESS TO MAKE SURE SOME OF THE SEVEN DEADLY SINS, QUITE MARGINAL, SOME TECHNIQUES ARE USED ALL THE TIME TO CREATE BENEFICIAL COUNTERMEASURES AND VACCINES AND DRUGS, WITH NOT STOPPED. SO IT ACTUALLY STARTED OFF AS AN ENABLING GROUP, NOT A RESTRICTIVE GROUP. I SAY THAT MAINLY AS BACKGROUND BECAUSE TOO OFTEN PEOPLE LOOK AT GROUPS LIKE THIS AS HOW CAN SCIENCE BE RESTRICTED, HOW IS THE GOVERNMENT GETTING INVOLVED IN OUR AFFAIRS, HOW ARE THEY STOPPING ME DOING GOOD SCIENCE? THAT WAS NOT THE ORIGINAL INTENT AND DON'T THINK IT NEEDS TO BE THE INTENT OF THIS GROUP IN ANY WAY. >> THANK YOU. >> OTHER QUESTIONS, COMMENTS FROM THE BOARD? >> ALL RIGHT, THANK YOU. >> LET ME MAKE SURE THERE'S -- (INAUDIBLE). >> ANY NSABB MEMBERS ON THE PHONE, AND IF SO DO YOU HAVE A QUESTION OR COMMENT? HEARING NONE, THEY ARE NOT ON SO THANK YOU VERY MUCH. >> THANK YOU. KEN, ALSO THANK YOU FOR THAT PERSPECTIVE OF THE INTENT OF THE BOARD, AND YOUR RECOMMENDATION THAT THAT INTENT THEN WAS GOOD AND SHOULD BE GOOD TODAY TOO. I WOULD LIKE TO INTRODUCE OUR NEXT SPEAKER, I'D LIKE TO INVITE DR. CHRIS HASSELL TO PROVIDE US DETAILS ON RECENTLY IMPLEMENTED HHS PANDEMIC PATHOGEN CARE AND OVERSIGHT FRAMEWORK. CHRIS? >> THANK YOU. IT'S GOOD TO SEE A LOT OF FAMILIAR FACES. I INTERACT WITH MANY OF YOU IN MY PREVIOUS POSITION AND WHEN I LEFT MANY OF YOU THOUGHT YOU WOULD NEVER HAVE TO FACE ME AGAIN. I APOLOGIZE THAT DIDN'T WORK OUT FOR YOU. BUT IT'S GOOD TO BE HERE. THIS IS A VERY IMPORTANT GROUP. IT'S USUALLY WHAT PEOPLE ARE EXPECTED TO SAY BUT I'LL GET INTO WHY I THINK IT'S SO IMPORTANT AND RELEVANT AND TIMELY THIS GROUP IS MEETING AND DOING THIS WORK. I BRING GREETINGS FROM THE SECRETARY FOR PREPAREDNESS AND RESPONSE, HE'S RATHER CONSUMED AT THE MOMENT BETWEEN EARTHQUAKES, CORONAVIRUS AND OTHER THINGS GOING ON. IT'S BEEN A BUSY FEW WEEKS. THAT ACTUALLY ALSO POINTS OUT WHY I THINK THE TIMING OF THIS IS SO EXQUISITE THAT THIS GROUP IS MEETING, THE CORONAVIRUS ISSUE IN PARTICULAR IN CHINA, AS IT'S DISPERSING IS TAKING UP A LOT OF TIME. THERE'S HIGH-LEVEL MEETINGS OF THE GOVERNMENT, LOW-LEVEL WORKING MEETINGS, OPERATIONAL MEETINGS, SO WE'VE LEARNED A LOT, LESSONS FROM THE PAST, IMPLEMENTING THOSE BUT THERE'S STILL A LOT OF ROOM FOR IMPROVEMENT, JUST IN THE OPERATIONAL SIDE. THIS WILL ALSO LEAD TO ANOTHER EMPHASIS ON NEED FOR MORE RESEARCH. AGAIN, IT COULD BE MORE TIMELY AS WE'RE SEEING THIS VIRUS REASSORT AND MUTATE AS IT SPREADS, IT'S POINTING OUT THE NEED FOR DOING THIS TYPE OF WORK. IT'S TIMELY BECAUSE SINCE THIS GROUP MET, I WAS EX OFFICIO ON NSABB FOR A NUMBER OF YEARS, SEVERAL OTHER POSITIONS, BECAUSE OF THE ADVANCES IN BIOTECHNOLOGY. SO SYNTHETIC BIOLOGY, ENGINEERING BIOLOGY, WHICH EVER SUBSET OF THAT WE'RE GOING TO USE, IS GROWING SO RAPIDLY, AND I DON'T NEED TO TELL THIS GROUP THAT, BUT WE'RE SEEING THAT AND SO HOW CAN THE GOVERNMENT RESPOND TO THAT IN GENERAL, FROM A FUNDING STANDPOINT, IF THERE IS A REGULATORY STANDPOINT, WHAT IS THE POSTURE THAT'S NEEDED, AND CAN WE KEEP UP WITH SOMETHING MOVING SO RAPIDLY. SEVERAL MEMBERS OF THE BOARD HERE SPECIALIZE IN THAT AREA SO THIS WILL BE IMPORTANT. BOTTOM LINE, THERE'S A LOT OF RELEVANT THINGS GOING ON NOW. AND SO WE'RE LOOKING FORWARD TO THE NSABB HELPING SOLVE ALL OF OUR PROBLEMS. I HAVE SOME SLIDES HERE, I ASSUME MOST PEOPLE READ THE FRAMEWORK AND ARE FAMILIAR. I'M NOT GOING TO READ -- I'LL SKIP SEVERAL TO GET TO SPECIFICALLY ON THE TRANSPARENCY ISSUE. WE'RE GOING IN REVERSE. WE HAVEN'T HAD THE CHARGE. BUT I WANT TO TALK PARTICULARLY ABOUT TRANSPARENCY QUESTION. SO THIS IS THE FRAMEWORK. CARRIE MENTIONED SOME TOPICS, SOME ISSUES. SO I'M NOT GOING TO BELABOR THEM. SHE MENTIONED THIS AS WELL. THE ONLY THING I'LL POINT OUT WHEN WE TALK ABOUT A P3 SITUATION, A LOT OF TIMES WE ACTUALLY ARE TALKING ABOUT ENHANCED P3 SITUATION, SOMETIMES WE'RE NOT ALWAYS CAREFUL ABOUT MAKING THAT DISTINCTION SO JUST BE AWARE OF THAT AT TIMES, AND ASK FOR CLARITY IF IT SEEMS LIKE THAT CLARITY IS NOT THERE. PPP HAS BECOME A EUPHEMISM FOR ENHANCED PPP ACTUALLY, SO THE P3CO REVIEW MEAT IS HOW IT'S REFERRED TO, IS THE GROUP THAT REVIEWS THE PROPOSALS FOR RESEARCH THAT HAVE BEEN FIRST OF ALL JUDGED AS HAVING SCIENTIFIC MERIT, BUT THEY ALSO TRIGGER SEVERAL ISSUES THAT -- IT'S LAID OUT IN THE FRAMEWORK AND OTHER AREAS THAT NEED FURTHER SCRUTINY. SO THIS COMMITTEE WAS FORMED AT THE RECOMMENDATION OF THIS GROUP, AND OUTLINED IN THE FRAMEWORK. I WANT TO FOCUS ON THE VERY BOTTOM HERE BECAUSE I KNOW THERE'S QUESTIONS ABOUT THE COMPOSITION OF THE COMMITTEE, WHO IS SITTING THERE, HAVING THESE DISCUSSIONS AND HAVING THESE DELIBERATIONS? I'LL TELL YOU, I CAME INTO THIS IN APRIL. THIS WAS ONE OF BOB'S GIFTS TO ME TO CHAIR THIS COMMITTEE. AND MANY OF YOU KNOW THERESA -- I'M SORRY, TRISHA DE LA ROSSA WHAT WAS THE DRIVING FORCE IN HHS DRIVING A LOT OF THIS SO A LOT OF CREDIT GOES TO TRISHA. AND I WILL TELL YOU SHE WAS VERY ADAMANT WE MAKE SURE WE STAFF THIS GROUP AS OUTLINED. SO, ALL THE DISCIPLINES ARE THERE, REPRESENTED IN THE GROUP, SOME AREAS ARE EASY TO FIND REPRESENTATIVES, OTHERS IT'S MORE OF A CHALLENGE, BUT SHE'S DONE A GREAT JOB AND THE PEOPLE COMING AFTER HER HELPING RUN THAT, THERESA LAWRENCE IS HERE, REPRESENTING THAT EFFORT AS WELL. SO, I KNOW ONE OF THE QUESTIONS, I'LL COME BACK TO IT, WE DON'T NAME THE ACTUAL INDIVIDUALS, BUT THERE IS VERY ROBUST GROUP HERE. I'LL TELL YOU, IT'S A TOUGH GROUP TOO. THIS ISN'T SOME RUBBER STAMP GROUP. THIS IS WHERE RIGHT NOW YOU DON'T SEE ALL THE EVIDENCE OF THAT. BUT IT IS A VERY TOUGH GROUP. EXPERTISE IS HIGH. VERY EXPERIENCED. VERY ACTIVELY INVOLVED IN RESEARCH. SO IT'S A VERY CRITICAL GROUP, A TOUGH GROUP TO GET THROUGH, A LOT OF ITERATION WITH PERFORMERS AND P.I.s, AND THE INSTITUTIONS AS THE PROCESS GOES ALONG BECAUSE THIS GROUP IS SO ROBUST. THESE ARE THE CRITERIA, AGAIN OUTLINED IN THE FRAMEWORK. I'M GOING TO CALL ATTENTION TO NUMBER THREE. IT SEEMS IT'S THE CRUX OF THE WHOLE ISSUE. IS THE RESEARCH THAT'S BEING PROPOSED TO -- DO THE BENEFITS OUTWEIGH THE RISKS AND HOW DO WE MAKE THE JUDGMENT AND COMMUNICATE THE DECISIONS ON THAT JUDGMENT. AND THE REST OF THIS IS EQUALLY IMPORTANT BUT THAT'S THE ONE THAT OFTEN COMES UP AND I THINK THAT'S AT THE HEART OF SOME OF THE TRANSPARENCY QUESTIONS I'VE ENCOUNTERED. AS A RESULT OF THE GROUP'S REVIEW A NUMBER OF DECISIONS COULD COME OUT OF THIS, FROM IT'S ACCEPTABLE FOR FUNDING, THE THIRD POINT I WOULD CALL YOUR ATTENTION TO MOST. RESEARCH IS ACCEPTABLE ON THE CONDITION CERTAIN EXPERIMENTS ARE MODIFIED. THAT'S WHERE THE EXPERTISE OF THE GROUP COMES TO FORE BECAUSE THAT DIALOGUE HAPPENS, ITERATION GOES BACK AND FORTH WITH PERFORMERS, YOU KNOW, WHETHER IT'S MAKING EXPERIMENTS MORE STEP-WISE, INCREASING BIOSAFETY LEVEL, THERE'S A NUMBER OF THINGS THAT ARE DONE, AND THEN KIND OF RELATED, THE FOURTH POINT, SOMETIMES IT'S NOT SO MUCH ON THE P.I. TO MAKE THE MODIFICATIONS BUT INSTITUTIONAL OR EVEN HIGHER LEVEL ADJUSTMENTS THAT NEED TO BE MADE OR ADDRESSED. AND THEN THIS GOES BACK TO THE FUNDING AGENCY. AND THEN THE DECISION IS MADE ABOUT HOW TO GO FORWARD. THEN IT'S COMMUNICATED UP TO HEAD OF OSTP, ULTIMATELY THE COMMUNICATION, ULTIMATELY POSTED. SO THAT WAS A QUICK RUN-THROUGH. I WANT TO SPEND TIME ON THIS SLIDE. I FIND THESE ARE BETTER WITH DIALOGUE VERSUS WAIT TILL THE VERY END. I YIELD TO THE CHAIR, HOWEVER YOU WANT TO RUN THE MEETING BUT I THINK LET'S DISCUSS THIS. I'LL TELL YOU, I MET WITH MANY OF THE PEOPLE IN THE ROOM, IN PARTICULAR TOM AND MARK, WHOSE PAPER DROPPED YET WITH YOU I'M -- DROPPED YESTERDAY I I A ASSUME PEOPLE HAVE SEEN. I MET WITH THEM A COUPLE TIMES IN THE INTERVENING MONTHS, AND MANY OF YOU. THE QUESTION I HAVE, WHAT DO WE MEAN BY TRANSPARENCY? THAT WORD JUST ALWAYS KIND OF GETS ME A LITTLE CONCERNED BECAUSE IT'S THROWN AROUND SO CONVENIENTLY. SO MY QUESTION OFTEN WHEN SOMEBODY SAYS YOU NEED TO BE MORE TRANSPARENT, I WILL SAY WHAT DOES THAT MEAN TO YOU? AND THAT'S SELDOM VERY WELL DEFINED. THAT CAN MEAN ITERATIVE PROCESS BUT I THINK THAT DIALOGUE, WHAT DO WE MEAN BY TRANSPARENCY? AND THERE'S A HUGE CONTINUUM WHAT THAT COULD MEAN BUT THAT DIALOGUE HAS TO HAPPEN, CAN'T JUST BE THE THE RECOMMENDATION OF HHS, NEEDS TO BE MORE TRANSPARENT, THAT'S NOT GOING TO BE HELPFUL. THE SECOND POINT IS ONE I MENTIONED BEFORE, DO THE BENEFITS JUSTIFY OR OUTWEIGH THE POTENTIAL RISKS? AGAIN, THAT'S ONE THAT I SEE MOST OFTEN. RELATED TO THAT, DOES THE PROCESS, OVERALL PROCESS THAT CARRIE OUTLINED, SORT OF HAS BEEN SPECIFIED INTO THE P3CO FRAMEWORK, DOES IT ENGENDER TRUST? AND HOW DID WE BETTER DOCUMENT THE DELIBERATIVE PROCESS THAT LEADS TO THE POSTED DECISION WHICH THEN COULD -- THAT TRUST, WHILE MAINTAINING INTEGRITY OF THE PEER REVIEW PROCESS, MAINTAINING, YOU KNOW, THE PRIVACY, THE PERSONAL ISSUES AND PERSONAL CONCERNS OF THE COMMITTEE MEMBERS, BECAUSE I HAVE BEEN ON SEVERAL SITUATIONS LIKE THIS WHERE NAMES GET OUT, YOU BECOME SUBJECT TO A NUMBER OF VULNERABILITIES, WITH MORE EXPLOSION IN SOCIAL MEDIA THAT'S BEEN MULTIPLIED. AS MUCH AS IT WOULD BE GOOD TO PUBLICIZE THE INDIVIDUAL NAMES, WHICH HAS BEEN SUGGESTED, IF THAT CHILLS ANYONE BEING WILLING TO SERVE ON THAT COMMITTEE, THAT WILL BE DETRIMENTAL BECAUSE WE DO MANAGE TO GET GOOD PEOPLE ON THAT COMMITTEE THAT GIVE OF THEIR TIME, TO WORK ON THIS THING. THAT'S ANOTHER AREA OF BALANCE THAT WOULD HAVE TO BE CONSIDERED. I COVERED THE NEXT ONE. SO, AGAIN, WHAT MORE CAN WE SAY? IS THERE A WAY TO SOMEHOW COME TO SORT OF SOLOMONIC COMPROMISE TO GIVE ENOUGH INFORMATION TO ASSURE PEOPLE HAVE THE RIGHT LEVEL OF EXPERTISE ABOUT NAMING THEM? AND I KNOW WHAT ONE CONCERN, WE'VE ADDRESSED IT, WE'VE BEEN, YOU KNOW, AGAIN WORKING WITH THE GOVERNMENT PARTNERS TO MORE TIMELY POSTING OF DECISIONS AND RELATED ACTIONS AND TIMELINES. WE'RE STILL GETTING THE PROCESS UNDERWAY. WE'VE ONLY DONE TWO, ONLY COMPLETED TWO REVIEWS. SO SOME OF THIS IS WORKING OUT KINKS IN THE PROCESS. WE'RE IN THE MIDDLE OF OUR THIRD REVIEW. YOU KNOW, THAT'S GOING. BUT THERE'S NOT A HUGE N POPULATION TO BASE OUR EXPERIENCE, TO MAKE MODIFICATIONS WE NEED. WE'RE NOT GETTING THESE THINGS IN, HOWEVER, WITH SUCH FREQUENCY THAT WE CAN WAIT MUCH LONGER BEFORE WE CONSIDER WHETHER TO REVISIT THE PROCESS. I'VE TALKED TO YOU, I KNOW WITHIN THE GOVERNMENT, INTERAGENCY, WE'VE TALKED ABOUT THIS. WE'VE EACH HAD 40 REVIEWS, DO WE HAVE GOOD STATISTICAL UNDERSTANDING WHAT'S WORKING, WHAT HASN'T? ON THE OTHER HAND ENOUGH QUESTIONS HAVE COME UP WE NEED TO REVISIT THIS NOW. SO AGAIN WE'RE GOING BACKWARDS. THE CHARGE THAT'S GOING TO COME OUT, THE FIRST PART IS DEALING WITH TRANSPARENCY ISSUE. I WAS GOING TO BRING UP A COUPLE OTHER ISSUES MORE ON THE SECOND PART OF THE CHARGE, THAT ARE NOT REALLY PART OF THIS MEETING AS I UNDERSTOOD IT. BUT I STILL WANT TO FRAME IT NOW. THIS IS A FEELING THE SCOPE OF THE FRAMEWORK IS TOO NARROW. TODAY WE'VE ONLY BEEN DEALING WITH INFLUENZA-RELATED PROPOSALS. THERE'S A DIAGRAM ON THE INSIDE REPORT THAT KIND OF MAKES THIS POINT, YOU KNOW, ALL THESE THINGS START BROAD, CARRIE TALKED ABOUT THE VERY BROAD POLICIES. NARROWING IT DOWN AND PPP IS VERY -- ONE VERY NARROW AREA OF THAT, WHICH HAS RESULTED IN ONLY GETTING A FEW INFLUENZA-RELATED PROPOSALS. I'LL JUST BE MORE FRANK THAN MAY BE APPROPRIATE, I THINK THAT'S TOO NARROW. SO WHAT IS THE REASON FOR THAT? MAYBE I'M WRONG. MAYBE THERE IS MORE RESEARCH THAT'S GOING OUT THERE THAT I JUST DON'T -- I'M SORRY, MAYBE RESEARCH IS NOT GOING ON THAT MAY BE ASSUMED, BUT I THINK THAT COULD BE REVISITED AND, AGAIN, THERE MAY BE DEFINITION ISSUES, SOME OTHER ISSUES. I KNOW JOE HAS TALKED ABOUT THIS, I'M PUTTING HIM ON THE SPOT A LITTLE BIT BUT HE GAVE A PRESENTATION AT ASM AND TALKED ABOUT THIS. I WILL POINT YOU TO JOE IF YOU HAVE QUESTIONS ABOUT THAT PARTICULAR ISSUE, IF YOU DON'T MIND. AGAIN, CAN WE DO MORE TO DEFINE THE SCOPE? ONE ISSUE THAT CAME UP, IT WAS INTERESTING, SO AT THE AMERICAN SOCIETY FOR MICROBIOLOGY MEETING THIS PAST SPRING, WE HAD A PANEL DISCUSSION ON THIS TOPIC, AND JOE WAS ONE OF THE PANELISTS, WITH MYSELF AND SEVERAL OTHERS. A MEMBER OF THE AUDIENCE BROUGHT UP THE ISSUE ABOUT USER FACILITY. THEY SUGGESTED ONE POSSIBLE SOLUTION TO THAT. SO IS THERE A WAY TO DO ENOUGH OF THE ENABLING RESEARCH UP TO A POINT WHERE YOU WOULD -- YOU KNOW, IT MIGHT CROSS SOME BOUNDARY TO BE MOST DANGEROUS AND THERE WOULD CROSS OVER INTO USING A USER FACILITY. YOU KNOW, LIKE EVERYTHING, THERE'S PROS AND CONS OF DOING THAT. I SPENT PART OF MY CAREER AT LOS ALAMOS, THE ULTIMATE USER FACILITY, IN MANY WAYS, AND I CAN TELL YOU THERE'S PROS AND CONS TO THAT APPROACH. BUT I THINK IT'S SOMETHING TO BE CONSIDERED. SO THESE ARE THE MAIN AREAS THAT CAME UP. LIKE I SAY, THE PAPER THAT TOM AND MARK PUT OUT HAS A NUMBER OF THINGS FOR CONSIDERATION. MY VIEW ON THIS THING IS DON'T USE TOO FINE A FILTER. IF THE COMMITTEE IS GOING TO CONSIDER A COURSE OF ACTION, AND YOU RUN UP AGAINST SOMETHING, WELL, THERE'S A LEGAL BARRIER TO THAT, WELL, YOU CAN CHANGE THE LAW. I MEAN, YOU KNOW, MY TIME ON THE HILL, I MEAN, THAT'S ONE FREQUENT REFRAIN I GET IS THAT IF IT NEEDS TO BE FIXED, WE'LL FIX IT. WE DO HAVE PEOPLE ON THE HILL FOLLOWING THIS ISSUE CLOSELY, GOOD ALLIES, ALL SIDES OF THE ARGUMENT HERE. SO THAT'S ONE EXAMPLE. DON'T LET POLICY, LEGAL ISSUES AND OTHER THINGS PREVENT FROM YOU AT LEAST EXPLORING SOME OF THE OPTIONS. AND THE NEXT STEPS, YOU KNOW, THIS WAS DOCUMENTED IN THE FRAMEWORK, WE'VE COME BACK TO THIS COMMITTEE TO ASK YOU TO REVIEW THE PROCESS AND SO I'M HAPPY TO SEE THAT'S HAPPENING. AND LASTLY I'M GOING TO USE MY WORD THAT I FUSS ABOUT, BUT WE ARE COMMITTED TO ENHANCING TRANSPARENCY. I SHOULD CAVEAT THAT, WHERE WE CAN, GIVEN THE CURRENT STRICTURES. BUT ABOUT THE REVIEW PROCESS AND ABOUT THE FUNDED PROJECTS, BUILD TRUST TO KEEP THIS WORK GOING. THE CONSEQUENCES OF NOT DOING THAT, HAVING RESEARCH OFFSHORE, HAVING IT GO UNDERGROUND FOR SOME REASON, YOU KNOW, AGAIN THAT'S ANOTHER ASPECT OF THIS THAT COULD BE A COMPROMISE PROBLEM. I WILL ADD ONE OF THE THINGS ABOUT THE PROCESS, THIS ONLY APPLIES TO FEDERALLY FUNDED RESEARCH. UNIVERSITY-FUNDED RESEARCH DOES NOT FALL UNDER THE CURRENT FRAMEWORK. WHAT VULNERABILITIES EXIST THERE, THAT MAY BEON BEYOND THE PURVIEW OF THIS GROUP BUT IS A REALITY. WE TRY TO POST WHAT WE CAN AS QUICKLY AS WE CAN AND WE'LL ENDEAVOR TO DO THAT EVEN FURTHER . I HAVE THREE MINUTES. ANY QUESTIONS? >> QUESTIONS FOR THE BOARD MEMBERS? I'LL TAKE THE CHAIR'S PREROGATIVE AND ASK FIRST. >> MICROPHONE PLEASE. >> SO I'LL TAKE THE CHAIR PREROGATIVE AND ASK THE FIRST QUESTION. AND HOW WOULD YOU DEFINE TRANSPARENCY OR HOW WOULD YOU LIKE TO SEE THAT OR MAYBE A DIALOGUE THAT WE COULD BETTER UNPACK WHAT TRANSPARENCY MAY MEAN IN THIS CONTEXT AND I'D LIKE THE BOARD MEMBERS TO MAYBE COMMENT ON THAT TOO. >> WELL, I'LL ANSWER THAT BY POINTING OUT SOME OPTIONS THAT HAVE BEEN PROFFERED IN MY DISCUSSIONS WITH FOLKS. ONE IS TO RIGHT NOW THE -- RIGHT NOW THE GROUP, REVIEW GROUP, IS COMPOSED OF ONLY FEDERAL EMPLOYEES. SHOULD WE AUGMENT WITH ACADEMICS, INDUSTRY PEOPLE, OTHER SUBJECT MATTERS EXPERTS IN OTHER AREAS, BIOSAFETY, BIOSECURITY, ETHICS? COULD WE AUGMENT IT WITH THAT? COULD WE PUBLICIZE THE DELIBERATIONS OF THE GROUP? CAN WE -- SHOULD WE IDENTIFY THE MEMBERS OF THE GROUP? THERE'S A NUMBER OF THOSE. I POINT BACK TO TOM AND MARK'S PAPER, BUT A LOT OF ARGUMENTS HAVE BEEN BROUGHT UP IN THE PAST. AND I WOULD SAY IF YOU'RE READING OTHERS, A LOT HAS BEEN PUBLISHED ABOUT THIS, YOU KNOW, THE GROUPS THAT CARRIE MENTIONED EARLIER THAT WEIGHED IN, I'D SAY IT NEEDS TO GO ON ALL SIDES OF THIS, YOU KNOW. IF YOU HAVE AN ISSUE OF TRANSPARENCY, TELL ME WHAT THAT MEANS TO YOU. >> JIM? >> THANK YOU VERY MUCH, CHRIS, FOR THAT NICE OVERVIEW. AND I AGREE WITH MANY CONCLUDING COMMENTS. VERY LAST STATEMENT ABOUT THE SCOPE OF THE RESEARCH THAT'S BEING REVIEWED, AND YOU SAID FEDERAL GOVERNMENT. IS THAT A CORRECT STATEMENT OR IS IT ONLY HHS? AND TODAY A LOT OF WORK IS BEING FUNDED BY NON-HHS AGENCIES, AND I'M WONDERING, ARE THESE -- THIS WORK BEING INCLUDED IN THE REVIEW? THANK YOU. >> RIGHT KNEW IT'S COME OUT OF HHS-FUNDED WORK. >> IS THERE A DISCUSSION TO BROADEN THE SCOPE SO THAT DARPA AND OTHERS MIGHT USE THIS REVIEW PROCESS? >> FOR THE MOST PART THEY DON'T GET INVOLVED IN THE WORK THAT WOULD FALL UNDER THIS. FOR THE MOST PART. A LOT IS ENABLING TECHNOLOGY BUT ACTUALLY MODIFYING, YOU KNOW, DANGEROUS PATHOGENS, BUT MAYBE IT'S WORTH A DOUBLE CHECK. THE LOOK ON YOUR FACE, MAYBE WE SHOULD CHAT OFFLINE ABOUT IT. >> [OFF MICROPHONE]. >> YEAH. GOOD QUESTION. >> THINKING THE SAME THING, WHEN WE WERE INVOLVED IN THE PART OF THE WHOLE DELIBERATIVE PROCESS, WORKING GROUPS AND WRITING THE REPORT AND ALL THAT, AND I THINK THAT WE WERE LIKE -- YOU KNOW, WE WERE KIND OF THEN TOLD THIS IS IN THE FRAMEWORK, THERE WOULD BE THIS -- AFTER REVIEW BUT IT WOULD BE OCCURRING IN THE VARIOUS -- NOT ONLY HHS BUT ALSO OTHER AGENCIES. SO ARE YOU AWARE THERE HAVE BEEN REVIEWS AND THEY HAVE BEEN HANDLED DIFFERENTLY IN OTHER AGENCIES OR IS IT JUST THERE HASN'T BEEN ANY PROPOSED RESEARCH THAT HAS RISEN TO THE LEVEL, TWO VERY DIFFERENT ISSUES. >> RIGHT. AGAIN, MORE SPEAKING ABOUT, FOR EXAMPLE, DEPARTMENT OF DEFENSE, NOTHING THAT HAS GONE ON AT THE DEPARTMENT OF DEFENSE WOULD HAVE FALLEN UNDER THIS. LIKE USAMRID, THE TYPES OF ORGANISMS THAT WOULD FALL UNDER THIS. I SHOULD POINT OUT THE COMMITTEE ITSELF, THE GROUP IS NOT ALL HHS EMPLOYEES. WE DO HAVE DEFENSE AND OTHER PEOPLE. JUST BECAUSE WE WANT TO PULL DISCIPLINES, COLLATERAL BENEFIT, SOME WE HAVE TO PULL BECAUSE OF THE POPULATION, FROM OTHER AGENCIES, SO IT'S KIND OF A CHECK ON THAT BUT -- >> BUT PROPOSALS ARE ALL NIH OR NIH AND NSF? >> ALL NIH. >> ALL NIH, THAT'S WHAT I THOUGHT. >> I HAVE SEVERAL HUNDRED QUESTIONS. [LAUGHTER] >> TWO MINUTES OVER. >> MARK DENISON. I'LL START WITH ONE AND MAYBE FRAME SOME DISCUSSION, THIS ISSUE, IN ONE OF OUR SLIDES, WENT BY QUICKLY, RISK AND BENEFIT, FRAMED IN PROFOUNDLY BENEFIT TERMS, BENEFIT TO HUMANITY, AND RISKS OF, YOU KNOW, RISK AND SOMETIMES APOCALYPTIC IN TERMS, WHICH IS PROFOUNDLY NOT HOW SCIENCE IS PERFORMED. AND SCIENCE IS INCREMENTAL AND DESIGNED BEST EXPERIMENT TESTING THAT AND LOOKING AT THAT OUTCOME AND MOVING FORWARD SO IT'S NOT DESIGNED IN SOME WAYS, SO HOW OVER THIS WHOLE PROCESS AND THAT'S TOO MUCH TO ASK RIGHT NOW BUT I THINK IT'S IMPORTANT BECAUSE I SEE THIS IN THESE PUBLICATIONS AND EVERYTHING COME OUT, RISK IS ASSUMED TO BE PROFOUND. RISK IS ASSUMED TO BE EVENTUAL AND ABSOLUTE IN SOME WAYS. AND WHEREAS BENEFITS ARE SHOWN AS MAYBE BEING INCREMENTAL OR MINIMAL. IT FEELS LIKE THAT'S THE TERMINOLOGY. HOW IS RISK -- HOW IS ABSOLUTE RISK DEFINED? >> I WOULD SAY BOTH ARE BROAD CONTINUUM. YOU KNOW, THE RISK FROM MINIMAL TO APOCALYPTIC, AND INCREASING KNOWLEDGE TO CURING ULTIMATE UNIVERSITY INFLUENZA VACCINE, BOTH OF THOSE ARE TO BE CONTINUED. THEY INTERACT, WHICH SQUARES THE PROBLEM IF NOT FURTHER. ONE EXAMPLE OF THAT IS I KNOW IF YOU HAVE THE DISCUSSIONS ABOUT THE BENEFIT, AND I'LL GIVE YOU MY BACKGROUND, I'M VERY MUCH AN APPLIED SCIENTIST, I APPRECIATE BASIC RESEARCH BUT I HAVE A BIAS, FROM MY OWN WORK. AND MY OWN CAREER. I WILL SAY THOUGH THAT SAYING SOMETHING IS PURELY ACADEMIC THAT REALLY IS NOT JUSTIFYING THE RISK I THINK IS A SLIPPERY SLOPE BECAUSE WE DO NEED TO HAVE A LOT OF FOUNDATIONAL WORK GO ON THAT COULD BE PULLED TOGETHER TO LEAD TO ULTIMATELY VERY GOOD APPLIED SOLUTIONS. BUT I STILL THINK THERE'S TOO MUCH UNKNOWN ABOUT A LOT OF THESE PROCESSES. THAT DOES JUSTIFY VERY BASIC RESEARCH THAT THE IMMEDIATE BENEFIT MAY NOT BE AS OBVIOUS. I DON'T KNOW IF THAT EVEN BEGINS TO ADDRESS YOUR QUESTION BUT I THINK IT IS AN IMPORTANT ISSUE. AGAIN, MAYBE JUST AS MUCH AS TRANSPARENCY IS OVERUSED, MAYBE THOSE TWO TERMS WITHOUT GIVING DEFINITION MAY BE PART OF THE PROBLEM. >> ONE OTHER IS THE ISSUE OF -- I DON'T THINK YOU MEANT THIS BUT I HEARD IT AS THE IDEA THAT WE'RE NOT GETTING ENOUGH OF THESE PROPOSALS SO WE SHOULD EXPAND THE SCOPE O OUR NET. THAT'S WHAT I HEARD, SORT OF. [LAUGHTER] I'M NOT SURE ABOUT THAT RATIONALE. SO I'D LIKE TO -- I JUST WANT TO THINK OF IT IN TERMS OF -- I PROPOSE THE ALTERNATIVE STRATEGY THAT THERE IS A SELF CENSORING LOSS, SCIENTISTS ARE RISK PRONE WHEN THERE'S A CERTAINTY THEY WON'T GET FUNDING OR IT WILL GET TIED UP IN A PROCESS THAT'S IRRETRIEVABLE AND THEY CAN'T GET THEIR SUPPORT SO THERE COULD BE A TREMENDOUS AMOUNT OF SELF-CENSORSHIP OCCURRING, THAT MIGHT BE WHY YOU ARE NOT SEEING PROPOSALS, THEY ARE ACTUALLY NOT DOING THAT. >> I APPRECIATE YOU POINTING THAT OUT. I MISSPOKE IF THAT'S WHAT I SAID. >> I DON'T THINK YOU MISSPOKE. I THINK I HEARD IT THAT WAY. >> SELECTIVE HEARING. >> I PHRASED EVERYTHING AS A QUESTION, I GET MYSELF OUT OF TROUBLE FROM HAVING GOTTEN MY BOSS INTO TOO MUCH OF A PICKLE. THE QUESTION IS, IS IT TOO NARROW? OTHER PEOPLE RAISED THAT QUESTION. YOU KNOW, YOU'RE RIGHT. PEOPLE ARE NOT JUST WILDCATTING, JUST OFF THE CALL IDEAS, AT LEAST THAT WE'RE SEEING. YOU KNOW, PEOPLE ARE THINKING THROUGH THESE THINGS, P.I.s I'M TALKING ABOUT, SELF SELECTION MAY BE TAKING CARE OF THIS, UP FRONT. I TOOK THE FIGURE OUT OF MY PRESENTATION FOR THE SAKE OF TIME BUT I GAVE YOU THE REFERENCE. IT'S IN THE REPORT ITSELF, FIGURE 3, IN THE I THINK 2016 REPORT. SO IF YOU'VE GOT THAT, I'VE GOT A HARD COPY I'LL LEAVE WITH GERRY IN CASE THAT HELPS WITH DISCUSSIONS. >> TWO QUICK THINGS IN DIRECT FOLLOW-UP. TO YOUR POINT, JIM, WORTH REITERATING OSTP POLICY DIRECTED REVIEW PROCESS, HHS WAS FIRST OUT OF THE DATE, THE REVIEW PROCESS CHRIS IS DESCRIBING, HHS-FUNDED WORK. OUR DEPARTMENTS AND AGENCIES WOULD HAVE TO SPEAK TO THEIR OWN REVIEW PROCESS. TO THE BEST OF MY KNOWLEDGE I DON'T KNOW OF ANY IN PLACE AND STRONGLY SUSPECT AT LEAST AT THE TIME WE HAD THESE DISCUSSIONS THAT WAS BECAUSE THIS WORK WAS SOLELY BEING FUNDED BY HHS, OBVIOUSLY A SNAPSHOT IN TIME THAT CAN CHANGE AT ANY POINT, BUT THAT'S THE REASON THIS IS HHS-FOCUSED BUT OSTP POLICY GUIDANCE DOES APPLY U.S. GOVERNMENT-WIDE. >> THANKS FOR CLARIFYING. I WILL PINT OUT, AGAIN, A LOT OF OTHERS ARE WAITING TO SEE WHAT HAPPENS AT HHS, A LOT OF COUNTRIES ARE ALSO DOING THE SAME THING. THE QUESTION HAS COME UP, WHAT IS THE INTERNATIONAL COMMUNITY DOING? WAITING TO SEE WHAT WE DO. SO NO ADDED PRESSURE BUT -- THE WORLD IS WATCHING EXPECTING US TO SOLVE THEIR PROBLEMS, NOT JUST OURS. >> YOU SAID A BULLET OF COMPETENCIES, DISCIPLINES OF THE MEMBERS OF THE REVIEW COMMITTEE, AND I GUESS YOU ONLY HAD TWO, TWO OR THREE, PROPOSALS TO GO THROUGH. BUT WHAT'S THE DYNAMIC IN THE COMMITTEE? HOW MANY OF THE MEMBERS ARE TRYING TO FIND A WAY TO MAKE IT POSSIBLE TO PROCEED AND HOW MANY ARE DRAGGING THEIR FEET TO REQUIRE BELT, SUSPENDERS, AND AIR BAGS TO PREVENT PROBLEMS? AND I'M THINKING TO MY TIME WITH HUMAN MEDICAL RESEARCH ETHICS COMMITTEES, WHERE THE CULTURE OF THE ONES I'VE BEEN IN ANYBODY IS LOOKING FOR ANY WAY THE VOLUNTEER IS AT RISK, AND IT'S A DIFFERENT DYNAMIC IN THIS KIND OF SETTING. >> LIKE I SAY, THE DISCUSSIONS ARE ROBUST. ALL THESE DISCIPLINES DO PARTICIPATE IN THE DISCUSSIONS VERY WELL. I'VE BEEN VERY HAPPY TO SEE THAT IT'S NOT JUST ON ONE HAND PEOPLE ARE NOT JUST SAYING NO BECAUSE IT'S EASIER. THEY MAY SAY NO BUT WITH A SUGGESTION, YOU KNOW, THAT'S WHAT I LIKE TO SEE, DON'T JUST TELL ME NO, GIVE ME A SOLUTION OR PROPOSE SOMETHING OR START DIALOGUE WITH THAT. NOBODY IS RUBBER STAMPING THIS. IT'S A TOUGH GROUP TO GET THROUGH SO NOBODY IS -- YOU KNOW, ME PERSONALLY, I HAVE AN n-OF-1 BUT THE DISCUSSION HAS BEEN BALANCED. MAYBE WE'VE BEEN INCREDIBLY FORTUNATE BUT I THINK THIS IS ONE OF THOSE SITUATIONS THAT MAKE MY ANSWER EASIER IF YOU COULD READ THE TRANSCRIPT. BUT I WONDERED ABOUT THAT. I'VE BEEN ON COMMITTEES WHERE IT IS JUST NO IS EASIER, OR YES IS EASIER. MAYBE PROPOSAL REVIEWS, IF WE'RE INTERESTED IN BODY OF KNOWLEDGE MOVING FORWARD, THEY WANT TO MAKE SURE IT'S DONE DELIBERATIVELY. >> ONE FINAL QUESTION AND YOU'VE GONE WAY BEYOND THE RED LIGHT. IT'S MY FAULT. WHO CHAIRS THE GROUP, CAN YOU SAY THAT? IS THERE A HIGHER LEVEL AUTHORITY THAT APPROVES THE COMMITTEE'S RECOMMENDATION? >> I CHAIR THE COMMITTEE. I'VE BEEN IDENTIFIED AS SUCH, SO NO PROBLEM WITH THAT. THE DECISIONS GO -- THERE'S A LETTER TO SIGN UP FROM NIH, MAY GO TO OSTP, THOSE PEOPLE ARE IDENTIFIED. @NIAID SIGNED THE LETTER TO DR. DROGEMMEYER. >> THANKS, CHRIS. >> THANK YOU. I'LL BE HERE THROUGH THE REST OF THE DAY, NOT TOMORROW UNFORTUNATELY. BUT THERESA, LAURA, WAVE YOUR HAND, I DON'T KNOW IF YOU'LL BE HERE. SEVERAL PEOPLE FROM THE -- SHE'S NOT WAVING. MATT SHARKEY IS HERE, SEVERAL PEOPLE FROM THE TEAM ARE HERE. YOU CAN ALWAYS REACH ME BACK THROUGH GERRY OR CARRIE. >> CHRIS, THANK YOU VERY MUCH. WE'RE NOW GOING TO BE CHARGED. CARRIE, I WILL TURN IT BACK OVER TO YOU TO GIVE THE NSABB A CHARGE. >> SINCE I HAVE THE MIC AND DEAD SILENCE, I SHOULD MAKE A COMMENT THAT I DIDN'T MAKE IN THE INTEREST OF TIME, WHICH IS THIS QUESTION OF SCOPE AND IS THE SCOPE RIGHT OR NOT RIGHT. I THINK IT IS WORTH NOTING THAT THAT SCOPE WAS ULTIMATELY TAKEN VERBATIM FROM THE NSABB DELIBERATIONS, WHICH TOOK PLACE OVER A TWO-YEAR PERIOD, LARGELY FOCUSED ACTUALLY ON SCOPE.% AND SO WHICH ISN'T TO SAY I'M FOR CONTINUOUS IMPROVEMENT BUT I WILL SAY THERE WAS A GREAT DEAL OF DISCUSSION ABOUT THAT, THAT SCOPE, INVOLVING MANY, MANY, MANY PEOPLE. AND SO, YOU KNOW, MUCH LIKE IF WE FOLLOW THE CONTINUUM OF DUAL USE RESEARCH OF CONCERN, OUR POLICY AT THE END OF THE DAY DOESN'T LOOK THAT MUCH DIFFERENT THAN THE FINK REPORT WHICH MAYBE WE CAN SAY AFTER A DECADE OF DISCUSSIONS, MAYBE THEY GOT IT RIGHT IN THE FIRST PLACE, SO PROBABLY WORTH THINKING IN TERMS OF THE AMOUNT OF WORK THAT WENT INTO THAT SCOPING. >> SO FIRST LET ME EXPRESS APOLOGIES FROM DR. LARRY TABAK, WHO WAS HOPING TO BE HERE TO DELIVER THE CHARGE BUT GOT CALLED AWAY TO LAST-MINUTE BRIEFING WITH THE SECRETARY. WE ALL HAVE BOSSES. AND SO HE WAS SORRY HE COULDN'T BE HERE TODAY. BUT I WANTED TO PRESENT THE NSABB WITH THE CHARGE, WE'LL BE KICKING OFF THE DISCUSSION FOCUSED ON THE FIRST PART OF THE CHARGE TODAY AND BE ADDRESSING THE SECOND PART OF THE CHARGE IN LATER MEETINGS. SO THE FIRST PHASE OF THIS CHARGE IS ABOUT THIS QUESTION OF BALANCING SECURITY AND PUBLIC TRANSPARENCY AS CHRIS ALLUDED TO, TO PROVIDE RECOMMENDATIONS TO OSTP AND HHS ON BALANCING CONSIDERATIONS REGARDING SECURITY AND PUBLIC TRANSAPPEARANCE WHEN SHARINGS INFORMATION ABOUT RESEARCH INVOLVING ENHANCED POTENTIAL PANDEMIC PATHOGENS, A CONTINUATION OF THE CONVERSATION WE'VE JUST BEEN HAVING. IN DEVELOPING RECOMMENDATIONS CONSIDER THE PROCESS OF ADOPTED BY HHS FOR THE REVIEW AND OVERSIGHT OF PROPOSED RESEARCH INVOLVING ENHANCED POTENTIAL PANDEMIC PATHOGENS, OF COURSE THE CHARGE DESCRIBED WHEN THIS WAS ANNOUNCED WE WOULD ASK THE NSABB TO WEIGH IN ON THIS. AND IT'S IMPORTANT TO NOTE THIS ISN'T A CONSIDERATION OF THE FRAMEWORK ITSELF PER SE BUT REALLY HOW CAN WE MAKE SURE THAT WE ARE HITTING APPROPRIATE BALANCE, RELATIVE TO THAT FRAMEWORK AND THE PROCESSES ASSOCIATED WITH THAT. AND I SHOULD NOTE THAT IS REALLY THE FOCUS OF THE DISCUSSION OVER THE NEXT COUPLE OF DAYS, REALLY RELATIVE TO THIS FIRST PHASE OF THE CHARGE. BUT WE DON'T LIKE TO KEEP YOU IN SUSPENSE FOR WHAT'S HAPPENING NEXT. WE WANTED TO MAKE YOU ARE AWARE OF THE NEXT PHASE OF THE CHARGE WHICH WE WILL BE DEALING WITH IN SUBSEQUENT CONVERSATIONS, RELATED TO THE DURC POLICY REVIEW AND EVALUATION. SO, THIS COMES FROM OSTP TO ANALYZE U.S. GOVERNMENT AND INSTITUTION POLICIES FOR OVERSIGHT OF DUAL USE RESEARCH OF CONCERN. DURC, TO EVALUATE EFFECTIVENESS IN ACHIEVING INTENT, EVALUATE IMPACT ON RESEARCH INSTITUTIONS AND U.S. GOVERNMENT'S ABILITY TO SUPPORT RESEARCH, IDENTIFY IMPLEMENTATION CHALLENGES, EFFECTIVENESS WITH REGARD TO PUBLICATION, PUBLIC COMMUNICATION AND DISSEMINATION OF DUAL USE RESEARCH METHODOLOGIES AND RESULTS, AND, AGAIN, JUST TO CLARIFY THIS IS THAT TWO-PRONGED POLICY I PRESENTED, THE U.S. GOVERNMENT'S POLICIES ON DUAL USE RESEARCH OF CONCERN, NOT THE P3CO FRAMEWORK, A SEPARATE POLICY, I'LL ADDRESS THAT IN A MOMENT. AND I WILL JUST SAY THIS HAS A NICE FULL CIRCLE EFFECT TO IT SINCE OF COURSE THESE POLICIES WERE BASED ON NSABB REPORTS AND DELIBERATIONS AND NOW WE'RE ASKING THE NSABB TO COME BACK AND CONSIDER THESE POLICIES AND I THINK WE, YOU KNOW, INFORMALLY BEGAN THIS PROCESS WITH THE STAKEHOLDER WORKSHOP THAT WE HAD A COUPLE YEARS AGO. I KNOW MANY OF YOU SEPTEMBER 2017 I THINK IT WAS, MANY OF YOU WERE IN ATTENDANCE SO WE'VE GOT SOME WORK WE CAN BUILD OFF OF THERE. AS PART OF THIS SECOND PHASE, THE NSABB SHOULD ALSO REEVALUATE THE DURC DEFINITION, BUILT INTO THE SCOPE OF THESE POLICIES, CONSIDERING ADVANCES IN LIFE SCIENCE RESEARCH, CONVERGENT WITH OTHER SCIENTIFIC DISCIPLINES AND SECTORS, EVALUATE EFFECTIVENESS OF THE DURC PATHOGEN LIST WHICH IS ONE OF THE CORNERSTONES OF THE DEFINITION AND SCOPE OF THIS POLICY AND EXPERIMENTATION TYPE CONSTRUCT TO DETERMINE IF THE APPROACH SUFFICIENTLY ADDRESSES POTENTIAL FUTURE THREATS INCLUDING LIFE SCIENCE, IF APPROACH TO CONDUCIVE RESEARCH -- APPROACH IS CONDUCIVE TO RISK MITIGATION AND WHETHER ALTERNATIVE APPROACHES WARRANT CONSIDERATION. SO, AGAIN, I'M PRESUMING I'M SPEAKING TO THE ROOM FULL OF DURC EXPERTS, BUT I WILL JUST NOTE FOR CLARIFICATION AT THIS PUBLIC MEETING THAT THE DURC POLICY IS CONSTRUCTED OF COURSE BASED ON A TWO-PRONGED SCOPE, A LIST OF PATHOGENS OF CONCERN AND A SERIES OF EXPERIMENTS, AGAIN BASED ON THE ORIGINAL THINK REPORT AND SUBSEQUENT NSABB CONSIDERATION, SO THIS IS ASKING FOR CONSIDERATION OF BOTH OF THOSE PIECES OF THE SCOPE. WITH REGARD TO RECOMMENDED POLICY GUIDANCE FOR DEVELOPMENT OF REVIEW MECHANISM, P3CO, THAT WE WERE JUST DISCUSSING, DEVELOP SECTION 8 AND PROVIDE RECOMMENDATION, INCORPORATION INTO POLICY FRAMEWORKS ASSOCIATED WITH RECOMMENDED REVISIONS OF THE DURC POLICY. SO TO BRING THIS INTO REAL ENGLISH, THIS IS OF COURSE WE'VE JUST DISCUSSED THAT THE P3CO POLICY AND FRAMEWORK REPRESENTS A SUBSET OF DURC, NOT INTEGRATED INTO THE DURC, A SEPARATE POLICY SO THIS IS ASKING NSABB TO CONSIDER WHETHER OR NOT OR HOW INTEGRATION OF THOSE TWO POLICIES SHOULD TAKE PLACE. IN ITS DELIBERATIONS NSABB SHOULD CONSIDER THE NEED FOR FLEXIBLE AND ADAPTIVE GOVERNANCE APPROACHES THAT KEEP PACE WITH SCIENTIFIC ADVANCES IN EVOLVING UNDERSTANDING OF RISKED AND BENEFITS, SO A LESS AND INTEGRATE POLICY AND CAN BE APPLIED TO MITIGATE RISK FROM RESEARCH OF CONCERN BUT OTHER BIOSECURITY AND BIOSAFETY CONSIDERATIONS THAT SHOULD BE VERY FAMILIAR GROUND BECAUSE I WOULD ARGUE THESE ARE THE OPERATING PRINCIPLES THE NSABB HAS BEEN OPERATING ALONG FOR MANY YEARS NOW. SO VERY MUCH IN LINE WITH OUR PREVIOUS WORK. SO JUST TO GIVE AN IDEA OF THE TIMELINE, HOW QUICKLY WILL WE BE EXPECTING YOU TO COMPLETE YOUR WORK, IMMEDIATELY FOLLOWING THIS MEETING WE EXPECT TO BE FORMING WORKING GROUPS TO DEVELOP WORK PLANS TO ADDRESS PHASE 1, FOR THOSE WHO HAVEN'T BEEN INVOLVED IN ADVISORY COMMITTEES BEFORE A LOT OF THE WORK ITSELF GETS DONE BY SMALLER WORKING GROUPS THEN BROUGHT BACK TO THE PARENT GROUP FOR DISCUSSION AND CONSIDERATION SO WE'LL BE FOLLOWING THAT PATHWAY. LATER IN THE SPRING OR EARLY SUMMER OF THIS YEAR NSABB WILL CONSIDER RECOMMENDATIONS RELATED TO PHASE 1 CHARGE, BALANCE OF SECURITY AND PUBLIC TRANSPARENCY, AND THEN WE'LL MOVE INTO PHASE 2 FOLLOWING THAT AND, AGAIN, FORM WORK GROUPS APPROPRIATE TO MEET THAT CHARGE AND WE CAN DISCUSS THAT AT A MEETING. ULTIMATELY AIMING FOR THE FOLLOWING SPRING TO DEVELOP RECOMMENDATIONS RELATING TO DURC AND THIS INTEGRATION QUESTION WITH THE P3CO POLICY. SO, THAT IS -- IT SEEMS LIKE A LONG TIME FROM NOW, BUT HAVING DONE THIS WORK PREVIOUSLY, THIS IS A PRETTY AMBITIOUS TIME LINE SO THANK YOU VERY MUCH FOR ALL OF YOUR CONTRIBUTIONS, IN ADVANCE, TO THIS GOING FORWARD. AND SO I'M HAPPY TO ADDRESS ANY QUESTIONS THAT YOU MAY HAVE. I'LL LEAVE THE TIMELINE UP SINCE IT'S PROBABLY MOST LIKELY. JIM? >> UNDER 2A, YOU HAD AN EVALUATION OF LIST OF PATHOGENS. IS THAT GOING TO BE COORDINATED IN SOME WAY WITH THE SELECT AGENT LIST? >> WE ALWAYS LOVE TO COORDINATE WITH THE SELECT AGENT PROGRAM. YEAH, I MEAN, I THINK IT IS IMPORTANT TO NOTE THAT IT IS A U.S. GOVERNMENT POLICY. IT WAS COORDINATED THROUGH TRANSAGENCY PROCESS, ACROSS THE GOVERNMENT. AND I THINK ALL OF THE NSABB DELIBERATIONS WILL BE VERY MUCH DONE IN THAT SPIRIT, WORKING CLOSELY WITH COLLEAGUES ACROSS THE GOVERNMENT. >> MAYBE I COULD COMMENT IT WOULD BE GOOD TO HAVE REPRESENTATION FROM THE SELECT AGENT OVERSIGHT PROGRAM, SOMEBODY SO THAT AT THE END OF THE DAY WE'RE STILL ON THE SAME PAGE ADMINISTRATIVELY. >> YEAH, THANK YOU. IT'S A GOOD SUGGESTION. >> [OFF MICROPHONE] I BELIEVE THE REASON I'M ON THE COMMITTEE IS FOR EXPERIENCE IN THE AGRICULTURE REALM, I'M PARTICULARLY A PLANT PATHOLOGIST. AND I SEE OBVIOUS CONNECTIONS WITH EVERYTHING THAT'S BEEN TALKED ABOUT TODAY BUT SINCE THE FOCUS OF THIS GROUP IS ON HUMAN MEDICINE, I'D LIKE TO HEAR YOUR PERSPECTIVES ON HOW AN AGRICULTURAL FOCUS OR CONSIDERATION WOULD BE PART OF THIS, OR WOULD IT AT ALL? >> YEAH, NO, THANK YOU. AN IMPORTANT THOUGHT. AS AN ANIMAL SCIENTIST, I RESONATE WITH THAT VERY MUCH. I THINK ON THE FIRST PHASE OF THIS CHARGE, THE BALANCE OF TRANSPARENCY AND SECURITY IS VERY HHS-FOCUSED, IT'S RELATIVE TO THE FRAMEWORK QUESTION THAT WE'VE TALKED ABOUT. SO, THERE I THINK IT IS MORE GENERAL EXPERTISE ON HOW DO WE APPROPRIATELY HIT THAT BALANCE. THE U.S. GOVERNMENT'S POLICY IS THE U.S. GOVERNMENT POLICY. IT TRANSCENDS HUMAN MEDICINE AND AGRICULTURE AND EVERYTHING IN BETWEEN, MUCH LIKE THE SELECT AGENT PROGRAM DOES. AND SO I THINK WE WOULD HIGHLY APPRECIATE YOUR EXPERTISE TO THAT, AND WHEN WE GET THERE. THE NSABB HAS BEEN LARGELY BUT NOT EXCLUSIVELY FOCUSED ON HUMAN PATHOGENS, AND SO WE HAVE DIPPED OUR TOES IN THE WATER OF AGRICULTURAL RISKS AS WELL. >> A COUPLE THINGS. ONE IS MEMORANDUM -- >> MICROPHONE PLEASE. >> OH, SORRY. MEMORANDUM OF AGREEMENT BACK IN 2004 SIGNED BY ALL THE CABINET MEMBERS BASICALLY SAYING THE NSABB RECOMMENDATIONS WERE SPEAKING FOR THE GOVERNMENT ALTHOUGH IT DOES NOT DICTATE A CONCLUSION OF THE NSABB MUST BE ADOPTED. EVERYBODY AGREED THAT THIS GROUP OR WHATEVER DERIVATIVE OF THIS GROUP COMES TO A CONCLUSION. IT REALLY IS U.S. GOVERNMENT-WIDE. I DON'T KNOW, IT WOULD BE NICE TO KNOW WHETHER THAT MEMORANDUM OF AGREEMENT HAS BEEN -- PARDON? GONE? IF IT'S STILL IN PLACE OR NOT. SECONDLY, DURC WAS NEVER INTENDED TO BE P3CO. FULL STOP. I MEAN, P3CO, WELL, GERRY IS HERE, GERRI EPSTEIN WROTE IT, HE SHOULD COMMENT. P3CO WAS DONE TO SOLVE A PROBLEM AT THE TIME, THE PUBLICATIONS AND SUCH, SO AT LEAST IT WAS THE IMPETUS TO START THAT PROCESS AND IT'S NOW DRIVEN THE NSABB WHICH HAD BEEN FLOATING IN THE BACKGROUND INTO TAKING A MORE ROLE WHICH I'M VERY GRATEFUL BUT AGAIN P3CO -- >> WE CAN ALL THANK JERRY EPSTEIN FOR THE ACRONYM, I WANT TO STATE FOR THE RECORD. >> HE CAN TELL US WHY HE PICKED THAT TERM. IS NOT THE BEGINNING. IT'S A BRANCH OF THIS OTHER ISSUE. I THINK THAT'S IMPORTANT TO KEEP IN MIND. AND THIRDLY, I CAN'T -- IF WE DON'T COORDINATE WITH, AS JIM LE DUC WAS TALKING ABOUT WITH THE SELECT AGENT GROUP, THIS WILL BE A MESS. AND I'VE BEEN -- I'M CONCERNED ABOUT THE SELECT AGENT GROUP, EVEN MORE THAN I'M CONCERNED ABOUT THE ARBITRARY LIMITATION OF DURC TO 15 ENHANCE THE PPPs. IF THIS DOESN'T WORK IN CONSORT WE'RE GOING TO END UP WITH CONFLICTING GOVERNMENT REGULATIONS, WHICH ONLY PEOPLE TRYING TO TAKE ADVANTAGE OF THE SYSTEM APPRECIATE. >> THANK YOU. PAM? >> PAMELA? >> POINT OF CLARIFICATION, I'M NEW SO I APOLOGIZE. IT SEEMS LIKE A POINT OF CONTENTION HERE FROM READING THE ARTICLE AND LISTENING TO THE PRESENTATIONS, IS THIS ISSUE AROUND WHO IS ON THIS COMMITTEE. SOUNDS LIKE WE'RE GOING TO SPEND TIME DISCUSSING WHETHER THAT SHOULD BE PUBLIC OR NOT. I WANT TO KNOW WHERE WAS IT DECIDED THAT IT SHOULDN'T BE PUBLIC? >> SO THIS MIGHT BE -- CHRIS, DO YOU WANT TO -- >> JUST SO WE HAVE BACKGROUND WHEN WE HAVE THAT DISCUSSION. >> SO I THINK PART WAS A LEGAL DECISION. THERE'S OTHER PRECEDENTS FOR THAT TOO, OTHER TYPES OF COMMITTEES LIKE THIS, AND OTHER AGENCIES. YOU JUST DON'T IDENTIFY THOSE PEOPLE, JUST TO MAKE SURE YOU ENSURE THEIR SAFETY AND SECURITY AND THEIR PRIVACY. MANY TIMES YOU WILL IDENTIFY EITHER LEAD EXECUTIVE, SOMEONE WHO TAKES ON THAT ADDITIONAL ROLE TO BE MORE PUBLIC FACING BUT I KNOW WHO TO ASK, WHO WOULD KNOW. >> I JUST WANTED TO KNOW IF IT WAS PART -- HAD COME FROM THIS COMMITTEE OR NOT BECAUSE AS I WAS READING THE ARTICLE, JUST NOW, AND LISTENING, I DO HAVE THE SENSE THAT THIS IS GOING TO BE A BIG PART OF THIS TRANSPARENCY DISCUSSION. >> YES, MARIE? >> SO I WAS A BIG PART OF THIS DELIBERATION, I THINK THE REASON, FIRST OF ALL, IT ENDED UP BEING THIS POINT, AVIAN FLU, IF HE LOOK AT THE CURRENT SITUATION THAT REALLY IS THE ONLY PPP THAT MEETS ALL THE CRITERIA FOR THE CLASSIFICATION OF BEING IDENTIFIED AS ENHANCED PPPs, BUT I THINK THAT ALSO SPEAKS, FROM MY PERSONAL VIEW, AND I HOPE FROM THIS BODY'S VIEW, IT WOULD BE SAD IF SOMETHING COMES UP AND WE DON'T HAVE A SESSION, SAY SOMETHING COMES TOMORROW, NEW VIRUS, AND WE KNOW IT'S POTENTIALLY ENHANCED PPP, WE SHOULDN'T JUST LET THAT FALL BETWEEN THE CRACKS, BUT I THINK I WAS WORRIED, I THINK A NUMBER OF THE PEOPLE ON THE COMMITTEE WERE WORRIED IF WE MADE THE LIST TOO BROAD FIRST OF ALL THE REVIEW PROCESS COULD BE DIFFICULT. SECOND OF ALL, WE WERE GOING TO STOP RESEARCH THAT WE DIDN'T REALLY HAVE ANY SERIOUS CONCERN AT THIS POINT IN TIME, MERS AND SARS BEING SOME, THAT THEY QUALIFIED AS PPP, IT ENDED UP BEING MAINY FLOW. THE OTHER THING AS FAR AS TRANSPARENCY IS CONCERNED, WE WANTED THIS TO BE AS TRANSPARENT A REVIEW PROCESS AS POSSIBLE, WHAT WE REALIZED SHOULD BE PRE-FUNDING SOME REVIEW OTHERWISE TOO HARD, WE DIDN'T NECESSARILY UNDERSTAND THAT THAT WOULD MEAN THAT IT WOULD (INDISCERNIBLE) WE TALKED A LOT COULD BE BROUGHT BACK LOSING THERAPY OVERSIGHT OR TO THIS FACA, SHOULD BE A FACA THING, AND THAT OBVIOUSLY HASN'T HAPPENED. I HAVE THE SAME KIND OF CONCERNS THAT PAM IS RAISING, THAT IF WE MAKE THIS TOO SECRET IT'S GOING TO REALLY BE NOT IN THE -- CONSIDERED TRANSPARENT. TRANSPARENCY COULD BE IN THE EYE OF THE BEHOLDER BUT IT'S STILL AN IMPORTANT CONCEPT. >> I THINK IT'S PROBABLY ALSO -- AND LOU, YOU PROBABLY REMEMBER THIS, HAVING BEEN THROUGH DELIBERATIONS, IMPORTANT TO NOTE THAT THE NSABB HEARD A LOT ABOUT AN EXISTING PROCESS AT THE TIME, INTERNAL HHS REVIEW PROCESS RELATED TO HIGHLY PATHOGENIC AVIAN INFLUENZA, WHICH ALREADY EXISTED, AND SERVED NOT AS THE BASIS BUT CERTAINLY CONTRIBUTED TO THE MOVEMENT TOWARDS THIS REVIEW PROCESS, AND THAT EXISTING PROCESS DID NOT IDENTIFY THE MEMBERS INVOLVED, THAT PREDATED MY ENTRY INTO GOVERNMENT SO LIKE CHRIS I SUSPECT IT WAS FOR THE DECISION MADE FOR LEGAL REASONS. BUT JUST NOTE THAT THIS NEWER PROCESS IS BUILT ON A FOOTPRINT OF EXISTING PROCESS, AND FOLLOWING THAT PATTERN OF TRANSPARENCY OR LACK THEREOF. >> WE'VE COME TO THE END OF THE TIME FOR THE SESSION. I WANT TO THANK YOU FOR THE DISCUSSION. YOU'VE GIVEN US A VERY SOLID CHARGE TO WORK ON. THIS IS GOING TO BE -- BUT IT'S A WORTHY CHARGE THAT NEEDS OUR VERY CAREFUL, THOUGHTFUL CONSIDERATION, BECAUSE THESE ARE COMPLEX ISSUES, AND WILL REQUIRE CONSIDERABLE AND VERY THOUGHTFUL CONSIDERATION BY THE BOARD AS WE MOVE FORWARD ON PHASE 1 AND PHASE 2, SO WE'VE GOT A LOT TO THINK ABOUT HERE. BUT IN THE INTERIM, WE NEED TO TAKE A SHORT BREAK AND CONTINUE THE REST OF THE DAY'S PRESENTATIONS AND PANEL DISCUSSION, SO LET'S TAKE A BREAK UNTIL 2:15, JUST A VERY SHORT BREAK. WELCOME BACK, EVERYBODY. WE CERTAINLY HAVE OUR HANDS FULL WITH THE WORK IN FRONT OF US. BUT I ALSO KNOW THE BOARD IS LOOKING FORWARD TO JUMPING IN AND DOING THE HARD WORK THAT WE'RE CHARGED TO DO. THIS AFTERNOON WE'RE GOING TO FOCUS AND HEAR PRESENTATIONS AND HAVE A PANEL DISCUSSION AND BE FOCUSING ON SOME INITIALLY ETHICAL POLICY CONSIDERATIONS SURROUNDING TRANSPARENCY AND SECURITY IN RESEARCH. WE WILL ALSO HEAR PERSPECTIVES ON APPROPRIATE BALANCE OF THESE ISSUES. I'D LIKE TO INVITE DR. DAVID RESNIK FROM THE NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES TO PRESENT ON THE ETHICAL CONSIDERATIONS AT HAND. AFTER EACH PRESENTATION WE HOPE TO HAVE TIME FOR QUESTIONS FROM THE BOARD MEMBERS. SO, WITH THAT, I WILL ASK -- DAVID'S AT THE PODIUM. >> THANKS FOR INVITING ME TODAY FOR THIS IMPORTANT TOPIC. SO, WE'VE ALREADY TALKED ABOUT TRANSPARENCY. I WANT TO THROW UP A DEFINITION OF TRANSPARENCY FROM MERRIAM-WEBSTER, THERE'S DIFFERENT SORTS OF ASPECTS TO IT, BUT BASICALLY IT'S THE IDEA OF VISIBILITY OF ACCESS OR ACCESSIBILITY TO INFORMATION, ESPECIALLY CONCERNING BUSINESS PRACTICES. ONE THING I WOULD LIKE TO POINT OUT ABOUT TRANSPARENCY THAT IT IS NOT JUST A MATTER OF THROWING OUT A BUNCH OF INFORMATION AT PEOPLE. IF YOU GIVE SOMEBODY, YOU KNOW, 20,000 PAGES OF DOCUMENTS AND THEY ARE NOT ORGANIZED, THEY DON'T KNOW HOW TO READ THEM OR FILE THROUGH THEM, THAT'S NOT TRANSPARENT TO THEM. OKAY? TRANSPARENCY REALLY IS A MATTER OF MAKING THE RESEARCH -- THE INFORMATION THAT'S SHARED MEANINGFUL AND USABLE TO THE PERSON YOU'RE SHARING IT WITH. THAT MAY MEAN FOR THE PUBLIC, FOR INSTANCE, THAT IF YOU WANT TO BE TRANSPARENT TO THE PUBLIC, THEY MAY NOT BE SO MUCH INTERESTED IN SCIENTIFIC DATA AND METHODS AS THEY WANT TO KNOW WHAT'S THE MEANING FOR SOCIETY, TRANSPARENCY TO THE PUBLIC FOR RESEARCH WE'RE CONCERNING. SO HERE ARE SOME DIFFERENT THINGS YOU CAN BE TRANSPARENT ABOUT. OBVIOUSLY WHEN WE'RE LOOKING AT RESEARCH PROJECTS, MATERIALS, METHODS, EQUIPMENT, FUNDING, FINANCIAL INTERESTS, THAT'S IMPORTANT TOO. YOU COULD BE TRANSPARENT ABOUT DETAILS OF PEER REVIEW DELIBERATIONS FOR GRANT REVIEW OR JOURNAL PEER REVIEW. AT SOME POINT THERE HAS COULD BE CONSIDERATION WHETHER INTELLIGENCE IS CONSIDERED FROM MAKING THESE DECISIONS. ALSO YOU COULD BE TRANSPARENT ABOUT THE PROCESSES FOR MAKING PEER REVIEW DECISIONS. TRANSPARENCY TO WHOM? WHEN YOU EVALUATE PROJECTS, HAVE YOU TO BE TRANSPARENT TO THE PEER REVIEWERS SO THEY CAN SEE WHAT THEY ARE REVIEWING, EVERYTHING, ALL THE DETAILS THEY NEED THAT WOULD INCLUDE FUNDING AGENCIES AND JOURNALS. SCIENTIFIC PUBLIC AS WELL WHEN WE'RE TALKING ABOUT PUBLICATION IN JOURNALS, OR PRE-PRINT SERVERS, PRESENTATIONS AT SCIENTIFIC MEETINGS, OTHER OUTLETS FOR SCIENTIFIC PUBLIC. BUT THERE ARE OTHER STAKEHOLDERS AS WELL, PUBLIC HEALTH COMMUNITY, POLICE, PHARMACEUTICAL, BIOTECH COMPANIES, INTERESTED IN THIS TYPE OF RESEARCH, AND AS WELL AS GENERAL PUBLIC. AND AGAIN I WANT TO STRESS DIFFERENT AUDIENCES MAY HAVE DIFFERENT INFORMATIONAL NEEDS OR EXPECTATIONS. SO IT MAY BE THAT TO BE TRANSPARENT TO ONE GROUP IS NOT THE SAME AS BEING TRANSPARENT TO ANOTHER GROUP. THAT'S SOMETHING YOU'LL HAVE TO -- THAT HAS TO BE CONSIDERED WHEN WE'RE TALKING ABOUT TRANSPARENCY. NOW WHAT'S IN FAVOR OF TRANSPARENCY? WELL, IT PROMOTES HONESTY, OPENNESS, PART OF THE ETHOS OF SCIENCE. IT'S ESSENTIAL FOR PEER REVIEW PROCESSES, FOR REPRODUCIBILITY OF SCIENCE, FOR CRITICISM OF SCIENTIFIC WORK, SCIENTIFIC DEBATE, HAVING RESEARCH THAT'S OBJECTIVE AND MAKING PROGRESS IN SCIENCE. IT CAN ALSO PROMOTE ACCOUNTABILITY FROM THE PUBLIC AND ALSO TRUST FROM THE PUBLIC AND OTHERS. TRANSPARENCY CAN BENEFIT THE PUBLIC BECAUSE THE INFORMATION THAT IS SHARED WITH THE PUBLIC CAN BE USEFUL TO THE PUBLIC FREEDOM OF EXPRESSION IS A BASIC HUMAN RIGHT, PART OF THE ETHOS OF SCIENCE. OBVIOUSLY THERE CAN BE PROBLEMS WITH TRANSPARENCY OR WE WOULDN'T BE HERE TODAY. AS WE MENTIONED EARLIER THERE COULD BE HARMS TO PUBLIC HEALTH, SOCIETY, THE ENVIRONMENT, NATIONAL OR INTERNATIONAL SECURITY. YOU COULD VIOLATE CONFIDENTIALITY OF THE PEER REVIEW PROCESS, DISRUPT ONGOING RESEARCH OR JEOPARDIZE SCIENTIFIC PRIORITY, VIOLATE RESTRICTION ON RELEASE OF PROPRIETARY INFORMATION IF THERE'S PRIVATE COMPANIES INVOLVED. AND YOU COULD VIOLATE RESTRICTION ON CLASSIFIED INFORMATION IF YOU'RE SHARING SOMETHING LIKE THAT. SO, I WOULD SAY GIVEN THE IMPORTANCE OF TRANSPARENCY, THE BURDEN OF PROOF SHOULD FALL ON, YOU KNOW, IF YOU'RE NOT GOING TO BE TRANSPARENT, I THINK THE STARTING PLACE SHOULD BE WE'RE GOING TO BE TRANSPARENT AND IF WE'RE NOT THEN WE HAVE TO GIVE A REASON WHY. A GOOD REASON WE'RE NOT BEING TRANSPARENT. SO WHAT ARE SOME OF THE REASONS? WELL, WE'VE TALKED ABOUT THEM A LOT SO FAR TODAY. THE BENEFITS AND RISKS OF DISCLOSURE. HOW LIKELY ARE THESE BENEFITS AND HARMS TO OCCUR, HOW CAN WE RELIABLY ESTIMATE PROBABILITIES AND WHAT EVIDENCE DO WE HAVE, HOW DO WE MAKE DECISIONS WITH UNCERTAIN OUTCOMES SUCH AS OUTCOMES RELATED TO PANDEMICS CAUSED BY ACCIDENTAL RELEASE OF PATHOGEN OR BIOTERRORISM. NOW, SOMETHING I'D LIKE TO POINT OUT ABOUT ALL THIS BENEFIT/RISK ASSESSMENT IS THAT IN MY OPINION, THIS IS EXTRAORDINARILY DIFFICULT TO DO, BECAUSE WE'RE TALKING ABOUT LOW PROBABILITY EVENTS, THAT ACTUALLY MAY HAVE NEVER OCCURRED AND WE'RE ESTIMATING PROBABILITIES BASED ON VERY LOW EVIDENCE, MAYBE MATHEMATICAL MODELING OR ASSUMPTION ABOUT THIS OR THAT COULD HAPPEN. SO, IT'S HARD ON THE ONE HAND, YOU CAN BE EXTREMELY RISK AVERSE, IF ANYTHING BAD COULD HAPPEN WE DON'T DO IT. BUT ON THE OTHER HAND YOU COULD SAY, OH, WE CAN FIGURE OUT PROBABILITY THIS NUCLEAR REACTOR WILL FAIL, OR WHATEVER, OR, YOU KNOW, BASED ON THIS MATHEMATICAL MODELING, ENGINEERING MODEL AND CALCULATE, HOW MANY LIVES LOST, HOW MUCH MONEY, RISK/BENEFIT CALCULUS, AND DOWNPLAY THE RISK THAT WAY BY THINKING THAT YOU HAVE A REALLY GOOD MATHEMATICAL OR STATISTICAL UNDERSTANDING OF THE RISK WHEN YOU REALLY DON'T. SO I THINK THIS IS SOMETHING THAT NEEDS A LOT MORE CAREFUL THOUGHT, AS FAR AS PEOPLE DOING SCIENCE IN THIS AREA, AS WELL AS PEOPLE THAT ARE IN THE BUSINESS OF ESTIMATING RISKS, AND HOW YOU GO ABOUT DOING THAT IN A RELIABLE AND ACCURATE WAY. SO, WHEN YOU'RE TALKING ABOUT PEER REVIEW NOW, AND YOU'RE BEING TRANSPARENT, YOU HAVE TO REALIZE HOW IMPORTANT CONFIDENTIALITY IS TO PEER REVIEW. IT PROTECTS REVIEWERS FROM RETALIATION, OBVIOUSLY, IT PROTECTS REVIEWEES FROM -- PROTECTS THEIR RESEARCH. YOU WANT YOUR RESEARCH TO BE, YOU KNOW, KEPT IN CONFIDENCE WHEN YOU'RE SUBMITTING IT. YOU DON'T WANT YOUR IDEAS STOLEN AND THINGS LIKE THAT. SO YOU HAVE TO THINK ABOUT HOW TRANSPARENCY IN THE PEER REVIEW PROCESS WOULD NEGATIVELY IMPACT CURRENT OR FUTURE PROCESSES BY SETTING A PRECEDENT OR SOMETHING LIKE THIS. THERE ARE LOGISTICAL ISSUES AND DISCLOSING PEER REVIEW DELIBERATIONS AND HOW YOU GO ABOUT DOING THAT IF YOU'RE GOING TO DO SOMETHING LIKE THAT. I KNOW THAT A LOT OF SCIENTIFIC JOURNALS ARE MOVING TO OPEN PEER REVIEW, WHERE EVERYBODY'S NAME IS OPENED UP AT SOME POINT BUT THERE'S STILL ISSUES WITH OPENING UP THE PEER REVIEW PROCESS. ONGOING RESEARCH, NOW THIS WOULD BE VERY DISRUPTIVE IF YOU'RE GOING TO START BEING TRANSPARENT ABOUT RESEARCH THAT IS ONGOING. AND HAS NOT COME TO COMPLETION YET BECAUSE THAT COULD JEOPARDIZE SCIENTIFIC PRIORITY AND THEIR RESEARCH BUT I DON'T THINK THAT'S PROBABLY WHAT WE'RE GOING TO BE TALKING ABOUT HERE ALTHOUGH I THINK IT'S SOMETHING THAT DES HAVE TO BE ON THE TABLE. BUT THEN YOU HAVE TO LOOK AT, YOU KNOW, ARE THE BENEFITS OF TRANSPARENCY IMPORTANT ENOUGH TO DISRUPT RESEARCH OR HARM PEOPLE'S CAREERS? PROPRIETARY INFORMATION, AGAIN, IF THERE'S ANY OF THAT INVOLVED YOU HAVE TO LOOK AT WHETHER THIS IS -- IF IT'S SIGNIFICANT ENOUGH TO, YOU KNOW, ALLOW FOR VIOLATIONS OF THIS, AND WOULD THE OWNERS OF THE PROPRIETARY INFORMATION BE WILLING OR AGREE TO DISCLOSE. CLASSIFIED INFORMATION, WILL THE GOVERNMENT AGREE TO RELEASE OF CLASSIFIED INFORMATION? I DON'T KNOW. I'M NOT PRIVY TO THAT KIND OF INFORMATION. I IMAGINE IT COULD BE VERY DIFFICULT, IF THERE'S INFORMATION ABOUT CERTAIN TERRORIST GROUPS AND CERTAIN CAPACITIES OF DIFFERENT COUNTRIES AS FAR AS BIOWEAPONS AND THINGS LIKE THAT. BUT THAT IS OBVIOUSLY INFORMATION THAT IS GOING TO BE USEFUL FOR SOMEBODY MAKING THESE DECISIONS TO HAVE, AND I DON'T KNOW HOW FAR TO THE PUBLIC THAT WOULD GO. OR TO PEOPLE IN THE KNOW. AND THEN, YOU KNOW, OBVIOUSLY PROBABLY NOTHING, WE WOULD BE TALKING ABOUT HERE BUT SOME PEOPLE OBVIOUSLY HAVE DONE IT IS THEY CONSIDER THE BENEFITS OF BREACHING CLASSIFIED INFORMATION, RESTRICTIONS, SIGNIFICANT ENOUGH THEY ARE GOING TO GO AHEAD AND VIOLATE THE LAW AND TELL THE WORLD THIS CLASSIFIED INFORMATION ANYWAY. SO WHAT ARE THE OPTIONS WE HAVE THEN? THIS IS -- THE OPTIONS, I'M NOT LOOKING AT THE DETAILS OF MINUTIA POLICY BUT WHAT POLICIES CAN DO GENERALLY. WELL, THERE'S OBVIOUSLY THE OPTION OF FULL DISCLOSURE. COMPLETE TRANSPARENCY AS MUCH AS YOU CAN. THEN ON THE OTHER SIDE OF THE TABLE, THERE'S THE OPTION OF NO DISCLOSURE. FOR EXAMPLE, MAKE THIS ALL CLASSIFIED RESEARCH. AND THEN IN BETWEEN IS PROBABLY WHAT WE'RE LOOKING AT, PARTIAL DISCLOSURE OF SOME KIND. NOT SHARING ALL THE DETAILS OF SCIENTIFIC PUBLICATIONS. THERE'S ISSUES THERE. YOU KNOW, THEN YOU GET INTO THE ISSUES OF REPRODUCIBILITY OF THE WORK AND HOW CAN YOU SHARE -- HOW CAN YOU PUBLISH SOMETHING IN A SCIENTIFIC JOURNAL NOT AL ALLOWING PEOPLE TO SEE YOUR METHODS OR SOMETHING LIKE THAT. ANOTHER OPTION WHICH DOES HAPPEN IN SCIENCE FROM TIME TO TIME, YOU BURY A PUBLICATION. YOU JUST PUT IT IN A TECHNICAL JOURNAL YOU KNOW ONLY THE EXPERTS ARE GOING TO READ AND YOU'RE NOT PUBLISHING IT IN "SCIENCE" OR "NATURE" AND NOT GETTING THE "NEW YORK TIMES" AND "WASHINGTON POST" WON'T PICK UP ON IT BUT PEOPLE THAT NEED TO KNOW KNOW WHERE TO GET THIS STUFF, THAT CAN BE USED FOR SOMETHING, I DON'T KNOW IF IT'S A GOOD THING TO USE FOR THIS KIND OF RESEARCH BUT PEOPLE HAVE DONE IT IN CONTROVERSIAL RESEARCH WHERE THEY DON'T REALLY WANT THE PUBLIC TO KNOW. SHARING INFORMATION WITH SELECT AUDIENCES INSTEAD OF PUBLISHING, YOU COULD CIRCULATE A PAPER TO MUCH SAY A STUDY OR PAPER ON A NEED TO KNOW BASIS, LIKE SAY ONLY PEOPLE WHO ARE TRUST THE RESEARCHERS -- TRUSTED RESEARCHERS OR HAVE THE DETAILS OF THE PAPER SO IT WOULD BE REDACTED AND THEN FOR THE GENERAL PUBLIC AND THEN THE PEOPLE THAT NEED TO KNOW WOULD SEE THE FULL DETAILS. THE PROBLEM WITH THIS IS FIGURING OUT WHO YOU WOULD SHARE IT WITH. HOW YOU WOULD ENSURE SECURITY AT SOME POINT, IF YOU'RE DOING SOMETHING LIKE THIS. SUPPOSE YOU SHARE IT WITH A RESEARCHER IN SOME LAB AND THEY SHARE IT WITH THEIR POSTDOC WHO MAYBE YOU WERE NOT -- YOU DID NOT VET THROUGH THE PROCESS OF SHARING IT, SOMETHING LIKE THAT. I ALSO THINK THAT IF YOU'RE GOING TO TAKE THIS SERIOUSLY YOU NEED TO DO SOMETHING LIKE A BACKGROUND CHECK ON PEOPLE YOU'RE SHARING IT WITH THAT WOULD BE EQUIVALENT TO MAKING PEOPLE GET A SECURITY CLEARANCE. AND IF YOU'RE GOING TO MAKE PEOPLE GET A SECURITY CLEARANCE, WHY NOT JUST MAKE THIS CLASSIFIED RESEARCH IN THE FIRST PLACE? RIGHT? SO IT'S KIND OF A WEIRD IN-BETWEEN THING WHERE YOU HAVE TO SHARE WITH A SELECT AUDIENCE. SHARING OF PEER REVIEW COMMENTS WITHOUT NAMING THE AUTHORS, YOU CAN SHARE VARIOUS THINGS IN PEER REVIEW, THE WHOLE PROCESS. YOU CAN SHARE WITH THE PUBLIC THE OVERALL RESULTS OF RESEARCH AND ITS SIGNIFICANCE BUT NOT SHARING ALL THE DETAILS WITH THE PUBLIC SO I THINK THERE'S LOTS OF OTHER PARTIAL DISCLOSURE OPTIONS I THINK BUT THAT'S PROBABLY WHAT I THINK WILL PROBABLY BE IN MANY CASES WORK OUT TO THE ETHICALLY BEST THING TO DO. SO THAT'S MY PRESENTATION. I'LL TAKE ANY QUESTIONS AT THIS POINT. >> QUESTIONS FROM THE BOARD? DO WE HAVE ANY BOARD MEMBERS ON THE PHONE? I GUESS NOT. SO THANK YOU FOR GIVING US THIS TO BEGIN TO CHEW ON. THAT WAS A VERY I THINK THOROUGH OVERVIEW OF THE -- I'M SORRY, GO AHEAD. >> MARK DENISON. I THINK SOME THINGS FEEL LIKE THEY ARE NONSTARTERS LIKE ISSUES OF BURYING INFORMATION FOR MULTIPLE REASONS, NOT TO MENTION SCIENTIFIC ETHIC OF IT, BUT THE ISSUE OF -- IN SOCIAL MEDIA ERA, AND THE WAY I EVEN TELL MY PEOPLE IN MY LAB IS THERE'S A LITTLE BIT IN SOME WAYS, EXCEPT IN SOME PEOPLE'S MINDS, LEVELING OF JOURNALS BECAUSE THE WAY YOU SEARCH FOR THESE, I LOOK AT "SCIENCE" AND "NATURE" FIRST, GO OUT AND QUERY THE INTERNET ON A DAILY BASIS AND IDENTIFY ANY ARTICLE WITH THESE WORDS IN IT SO I THINK THAT'S NO LONGER POSSIBLE, FOR THAT REASON. ALSO RISK OR ADVERSE TO THE DIRECTION THE NIH IS GOING CERTAINLY IN TERMS OF OUR DISPLAY OR CLARITY, TRANSPARENCY RIGOR, REPRODUCIBILITY OF OUR WORK. WE'RE GOING TO BE REQUIRED REALLY IN THE SHORT TERM FOR THE ORIGINAL DATA FROM OUR NOTEBOOKS ESSENTIALLY IS GOING TO HAVE TO BE PUBLISHED ALONG WITH OUR WORK AT SOME POINT. AND SO I THINK THAT WE -- THIS REALLY BRINGS UP THIS PROBLEM I THINK IN MORE CLARITY, RESPONSIBILITIES FOR THINKING ABOUT THE PROBLEMS AHEAD OF TIME. >> YEAH, I TOTALLY AGREE WITH YOU. I GUESS I WAS THROWING, AS I WAS TOLD, TO APPROACH THINGS AT A VERY GENERAL LEVEL AND OBVIOUSLY THERE'S SOME THINGS WE'RE GOING TO THROW OUT, OKAY, YOU COULD TRY THIS BUT THERE'S ALL SORTS OF REASONS THIS IS NOT GOING TO WORK, RIGHT, JUST NOT WHAT WE DO. BUT, YEAH. >> THANK YOU, DAVID. WE'RE GO TO OUR NEXT SPEAKER. I AM PLEASED TO WELCOME DR. GIGI GRONVALL, ASSOCIATE PROFESSOR IN THE DEPARTMENT OF ENVIRONMENTAL HEALTH AND ENGINEERING AT THE JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH TO INFORM US ABOUT HOW THESE ISSUES ARE ADDRESSED AND SOME RELEVANT POLICIES. GIGI? >> THANKS. THANK YOU FOR THE OPPORTUNITY TO TALK TO YOU TODAY. AS LONG AS I CAN TALK, I WILL DO MY BEST. SO I WAS ASKED TO TALK ABOUT SOME OF THE DOMESTIC AND INTERNATIONAL CONSIDERATIONS THAT AFFECT YOUR DECISION MAKING AROUND THE P3 -- ENHANCED P3 PROCESS. I'LL START WITH INTERNATIONAL. THE MOST IMPORTANT PART OF THE INTERNATIONAL FRAMEWORK THAT YOU NEED TO CONSIDER FOR THIS TYPE OF RESEARCH IS THE RULES AND COMPLIANCE WITH BIOLOGICAL WEAPONS CONVENTION. THE BWC IN CASE YOU'RE NOT FAMILIAR, IT'S BEEN IN FORCE SINCE 1975, AND ALL THE NATIONS THAT ARE PART OF IT AGREE TO NOT MAKE BIOLOGICAL WEAPONS, AND USE THEM. AND AS PART OF THIS PROCESS, THERE IS SOMETHING CALLED CONFIDENCE BUILDING MEASURES WHERE NATIONS PUT FORTH RESEARCH AND FACILITIES THAT HAVE POTENTIALLY DUAL USE CHARACTERISTICS, THAT -- SINCE VERIFICATION IS SUCH A DIFFICULT THING FOR BIOLOGICAL WEAPONS WHICH CAN HAVE A SMALL FOOTPRINT, YOU HAVE THIS PROCESS WHERE YOU SHARE INFORMATION ABOUT WORK THAT'S ONGOING, THAT COULD LOWER BARRIERS TO BIOLOGICAL WEAPONS DEVELOPMENT. SO, CLASSIFIED RESEARCH IS PERMITTED, OF COURSE. THERE IS CLASSIFIED RESEARCH IN BIOLOGY. BUT IT IS CONTROVERSIAL. PARTICULARLY WHEN IT BECOMES REVEALED IN DRAMATIC FASHION. AND SO RESEARCH PROJECTS THAT ARE NOT PART OF THIS CONFIDENCE BUILDING MEASURE HAVE MADE NEWS IN THE BWC PROCESS. THERE'S ALSO THE U.N. SECURITY RESOLUTION 1540 WHICH IS NOT AS IMPORTANT TO YOU BUT FOR COMPLETENESS, NATIONS AGREE THAT THEY WILL DO WHAT THEY CAN TO PREVENT NON-STATE ACTORS FROM MISUSING BIOLOGICAL MATERIALS AS WELL AS OTHER WMDs. SO ON THE DOMESTIC SIDE THE MOST IMPORTANT THING FOR YOU TO BE CONCERNED ABOUT IS THE NATIONAL SECURITY DECISION DIRECTIVE 189 WHICH CAME ABOUT IN 1985, AND IT WAS FOCUSED ON EASTERN BLOC SOVIET UNION TAKING SCIENCE AND TECHNOLOGY ADVANCES PUT FORTH BY THE UNITED STATES SNT ENTERPRISE AND AND USING IT FOR THEIR BENEFIT. THE NSDD 189 CAME DIRECTLY OUT OF A NATIONAL ACADEMIES OF SCIENCE REPORT CHAIRED BY DALE CORSON, WHO WAS PRESIDENT EMERITUS OF CORNELL, ALSO A NUCLEAR PHYSICIST. AND THEY CAME VERY MUCH ON THE SIDE OF OPENNESS IN THIS REPORT SAYING THAT WHAT THE UNITED STATES SHOULD DO, WHAT THE LARGER SECURITY BENEFIT TO THE UNITED STATES WOULD BE, IS TO HAVE SECURITY BY ACCOMPLISHMENT, TO DO -- TO HAVE A ROBUST VIBRANT RESEARCH ENTERPRISE BASED ON OPENNESS AND GOOD SCIENTIFIC PRINCIPLES. AND THAT THE BENEFITS TO SECURITY FOR THE U.S. WERE GREATER IN THAT OPENNESS AND EMBRACING THE RESEARCH ENTERPRISE THAN IN CARVING OUT AREAS THAT WOULD BE IN CONTROL OF UNCLASSIFIED INFORMATION. THERE ARE TODAY CUI CONTROLLED UNCLASSIFIED INFORMATION BRACKETS, THERE'S HIPAA INFORMATION, FERPA, ITAR, LARGELY RESEARCH IN THE U.S. HAS BEENENED THIS OPENNESS FRAMEWORK REAFFIRMED AFTER 9/11, AND RECENTLY IN A REPORT THAT JUST WAS PUBLISHED LAST WEEK, ALTHOUGH THE REPORT IS DATED IN DECEMBER, THE ALEET INDEPENDENT GROUP OF SCIENTIST, THE JASONs, WHO ADVISE THE U.S. GOVERNMENT ON SCIENCE AND SECURITY MATTERS CALLED FOR A REAFFIRMING OF NSDD 189 BECAUSE -- SAYING IF YOU ARE GOING TO HAVE RESEARCH THAT IS GOING TO BE UNDER CONTROL SO IT'S NOT FULLY OPEN TO JUST CLASSIFY IT AND TO NOT -- AND THEY COME OUT VERY MUCH AGAINST USE OF CONTROLLED UNCLASSIFIED INFORMATION TO FURTHER CARVE OUT AREAS WHICH ARE NOT OPEN TO SCIENCE. AND THAT THE LONG-TERM SECURITY OF THE RESEARCH ENTERPRISE IS BEST FOR THIS EMBRACING THIS OPENNESS. AGAIN, THERE ARE PLACES FOR CLASSIFIED RESEARCH. CLASSIFIED RESEARCH IS DONE IN MANY PLACES IN THE U.S. I MENTIONED N.B.A.C WHERE THREAT CHARACTERIZATION RESEARCH IS DONE FUELED BY INTELLIGENCE CONSIDERATIONS, AND TO BETTER CHARACTERIZE THE BIOLOGICAL THREATS WE MAY FACE. ONE OF THE THINGS THAT'S BEEN APPARENT IN THE LAST COUPLE DECADES IN THIS SPACE IS OFTEN THERE'S A NEW PAPER THAT WILL COME OUT OR A NEW CAPABILITY, NEW BIOTECHNOLOGY WILL COME OUT, PEOPLE WILL SAY HOW DOES THIS AFFECT OUR SECURITY? AND IT'S IMPORTANT TO BE ABLE TO HAVE A FRAMEWORK TO BE ABLE TO SAY, IS THIS REALLY LOWERING BARRIERS TO BIOLOGICAL WEAPONS? IS THIS REALLY MUCH WORSE THAN OUR -- IS OUR SITUATION MUCH WORSE THAN IT WAS BEFORE? PEOPLE WILL ARGUE ABOUT IT BUT IT'S NICE TO HAVE AN OBJECTIVE FRAMEWORK. AND THIS IS WHAT THIS REPORT DOES. BIODEFENSE IN THE AGE OF SYNTHETIC BIOLOGY, TITLE MEANT TO ECHO THE FINK REPORT IN THE AGE OF TERRORISM. DoD PAID FOR THIS REPORT, AND WAS FORTUNATE ENOUGH TO BE ON THE COMMITTEE. AND SO I WANT TO WALK YOU THROUGH A COUPLE THINGS PART OF THIS REPORT. I ENCOURAGE YOU TO READ IT. BECAUSE THERE'S MORE TO A BIOLOGICAL WEAPON IF YOU'RE THINKING OF HOW A PARTICULAR DUAL USE AREA OF RESEARCH COULD BE MISUSED, IT'S MORE THAN JUST THE INFORMATION. THERE'S MORE TO IT. THERE'S-- WHO IS GOING TO USE IT? WHAT ARE THEIR CAPABILITIES? WHERE ARE THEY -- WHAT KIND OF INSTITUTIONAL PULL DO THEY HAVE TO GET THE MATERIALS THAT THEY NEED? SO THERE'S LOTS OF DIFFERENT THINGS. AND THEN ALSO THE POTENTIAL FOR MITIGATION. SO THIS IS A FRAMEWORK, SO IT ALLOWS YOU TO WALK THROUGH, HUH, CRISPR IS BEING USE THIS WAY, HOW DOES THAT CHANGE THE SECURITY PICTURE THAT WE HAVE? AND SO IT GIVES YOU AN OBJECTIVE FRAMEWORK WHICH IS IMPORTANT IN THIS SPACE. AND WITH DR. DULIUS, AT NATIONAL DEFENSE UNIVERSITY, WE USED THIS FRAMEWORK TO EVALUATE -- YOU MAY BE FAMILIAR WITH THE HORSEPOX SYNTHESIS, APPLIED THIS FRAMEWORK TO SAY IS THIS -- WAS THIS MORE -- DOES THIS LOWER BARRIERS TO BIOLOGICAL WEAPONS DEVELOPMENT OR NOT? AND TO CONSIDER THIS. THERE ARE OTHER FRAMEWORKS THAT ARE AVAILABLE TO YOU, THERE'S SO MANY REPORTS OUT THERE ON THIS TOPIC. BUT THERE'S ALSO -- NSABB, AN EARLIER ITERATION OF NSABB PRODUCED THIS, HOW TO BE ABLE TO COMMUNICATE, SO YOU CAN SEE THE NICE COVER IN REAL LIFE. HOW TO COMMUNICATE DUAL USE RESEARCH. SO THERE ARE OTHER WAYS TO LOOK, TO BE ABLE TO EXAMINE THE PROBLEM IN AN OBJECTIVE WAY, AND EVERYBODY CAN AGREE THAT THESE ARE THINGS TO CONSIDER, EVEN IF YOU COME OUT WITH DIFFERENT CONCLUSIONS AT THE END. SO HAVING BEEN PART OF THESE TYPES OF CONVERSATIONS BEFORE I JUST WANT TO HAVE A FEW REFLECTIONS ABOUT THIS. OFTEN SAFETY AND SECURITY GET MUDDLED IN THESE CONVERSATIONS. I WOULD ENCOURAGE YOU TO AS MUCH AS POSSIBLE KEEP THEM SEPARATE. WHEN NSABB FIRST CALLED -- RAISED THE ALARM ABOUT AVIAN INFLUENZA GAIN-OF-FUNCTION PAPERS IT WAS A SECURITY -- THEY MADE THE -- THE EMPHASIS WAS ON SECURITY. LATER ON IT BECAME ABOUT SAFETY. BOTH ARE VALID ISSUES TO DISCUSS, BUT WHEN THEY ARE MUDDLED TOGETHER THEY -- IT'S NOT AS HELPFUL BECAUSE DIFFERENT ACTIONS AND MITIGATION MEASURES WOULD FOLLOW DEPENDING WHETHER YOU'RE CONCERNS ARE SAFETY VERSUS SECURITY. YOU CAN BE TRANSPARENT ABOUT THE SAFETY MECHANISMS THAT ARE PUT INTO PLACE FOR THIS RESEARCH, I THINK THAT MOST PEOPLE WOULD AGREE THAT THAT WOULD WOULD BE A GREAT IDEA, IT WOULD BE NICE TO HAVE A STANDARD FOR THIS. I CALL ON THE RIGHT THERE, PART OF THE WORLD HEALTH ASSEMBLY, WHICH IS THE GOVERNING BODY OF THE W.H.O. AFTER THERE WERE SARS LABORATORY ACCIDENTS, THEY CAME OUT WITH THIS RULING BASICALLY ENCOURAGING PEOPLE TO -- NATIONS TO BEEF UP THEIR LAB SAFETY. THERE ARE THINGS THAT COULD BE DONE IN THAT REALM ON THE INTERNATIONAL AND DOMESTIC LEVEL THAT WOULD PROMOTE SAFETY AND BE A GOOD IDEA. SAME WITH SECURITY. BUT OFTEN THEY ARE MUDDLED, AND IT DOESN'T LEAD TO PRODUCTIVE ACTION. I WANT TO CALL ATTENTION THAT THE DEBATE OVER WHETHER OR NOT THIS WORK IS VALUABLE OR SHOULD BE FUNDED AT ALL HAS CONTINUED IN SPITE OF MANY THOUSANDS OF HOURS OF MEETINGS AND HIGH LEVEL MEETINGS, AND EVERYBODY HAS ACCESS TO THE SAME INFORMATION. IT JUST -- IT'S IMPORTANT TO KNOW THERE MIGHT NOT BE AN AGREEMENT THAT RESULTS AT THE END OF THIS. FINALLY THERE'S A NUMBER OF THINGS IN QUESTION, MAYBE THIS IS ITS OWN FRAMEWORK, WHO THE RESEARCHERS ARE, URGENCY OF THE THREAT, WHAT THE RESEARCH IS TRYING TO ADDRESS. THE DANGER THAT THE INFORMATION COULD BE APPLIED TOWARD BIOLOGICAL WEAPON. ALL THESE FACTORS WILL INFLUENCE WHETHER SOMETHING IS FUNDED OR NOT. AND DIFFERENT TIMES MAY LEAD TO A DIFFERENT CONCLUSION AT THE END OF IT. I ALWAYS THOUGHT IT WAS INTERESTING THAT THE SEQUENCING AND SUBSEQUENT SYNTHESIS OF THE 1918 FLU VIRUS DIDN'T SEEM TO MAKE -- WASN'T AS CONTROVERSIAL AS SOME OTHER SYNTHESIS EXPERIMENTS I THINK BECAUSE AT THAT TIME THERE WAS A LOT MORE CONCERN ABOUT FLU AND THERE WAS A LOT MORE ACCEPTANCE THAT THIS RESEARCH NEEDED TO BE DONE SO THINGS CHANGE AND IT'S HARD TO IMAGINE THIS RESEARCH IN A VACUUM. AND FINALLY, A FRAMEWORK POLICY THAT WILL ALLOW YOUR DECISIONMAKING PROCESS TO BE TRANSPARENT IS ALWAYS USEFUL, BUT NO MATTER HOW MUCH PROCESS, AND YOU HOPE THE PROCESS WOULD BE HELPFUL THAT'S PUT ON A DECISION, THE QUESTION OF WHO DECIDES WILL ALWAYS BE CONTROVERSIAL. I GO INTO A LOT MORE OF THIS IN THESE PAPERS THAT I USED FOR THIS PRESENTATION. IT HASN'T COME UP YET BUT JUST IN CASE BECAUSE IT OFTEN DOES IN THESE CONVERSATIONS, IN 1977 THE INFLUENZA VIRUS THAT CIRCULATED THAT YEAR WAS DEFINITELY NOT NATURAL BECAUSE IT WAS IDENTICAL TO A VIRUS THAT CAME ABOUT IN THE 1950s, AND THERE'S A LOT OF DEBATE AND PREVIOUS GAIN-OF-FUNCTION DISCUSSIONS OF WHAT WAS -- HOW THAT CAME TO BE, AND IN THAT PAPER WE GO THROUGH SOME DIFFERENT SCENARIOS AND COME DOWN ON PROBABLY IT WAS THE RESULT OF A VACCINE TRIAL THAT WENT SERIOUSLY AWRY, AND BUT IT PROBABLY INVOLVED THOUSANDS OF PEOPLE IN THE TRIAL. I'M HAPPY TO TAKE QUESTIONS. THANK YOU SO MUCH, AND I'M SORRY ABOUT MY VOICE. >> GIGI, THANK YOU. QUESTIONS FROM THE BOARD? PAMELA? >> THANKS. THAT WAS REALLY GREAT. A WHOLE BUNCH OF QUESTIONS BUT I'LL GO WITH ONE HERE. SO, YOU BROUGHT UP CUI AND THE JASON REPORT THAT WAS QUITE INTERESTING. I'M WONDERING, SO MY UNIVERSITY, I DON'T KNOW IF IT'S GENERAL, DOES NOT ALLOW US TO DO ANYTHING WITH CUI, I DON'T KNOW IF THAT'S GENERAL TO ALL UNIVERSITIES. >> CONTROLLED UNCLASSIFIED INFORMATION. >> IT'S A BUZZ TERM THAT -- IT'S APPEARING MORE AND MORE WHICH IS I GATHER WHY THERE WAS A JASON DISCUSSION ABOUT IT. BUT SO THERE'S ONE ASPECT OF IT IS THESE ARE THINGS THAT HAVE TO DO WITH DEFENSE AND THEY SHOULD -- BUT THERE'S ANOTHER ASPECT THAT YOU BELIEVE IS THAT IS RELATED, AND IT'S RELATED TO THIS MERGING OF BASIC ACADEMIC RESEARCH AND THE PRIVATE SECTOR. >> RIGHT. >> SO CUI ALSO APPLIES TO IF YOU'RE A COMPANY AND YOU'RE GOING TO MAKE A PRODUCT AND PROFIT, CUI ALSO APPLIES TO THAT. I DON'T REALLY HAVE A QUESTION BUT THERE'S THIS MERGING OF ACADEMIA WITH THE PRIVATE SECTOR, AND COMMERCIALIZATION IS A HUGE BUZZWORD ON CAMPUS. SO THERE'S ANOTHER SIDE TO CUI I GUESS WHAT I'M SAYING. I'M NOT SAYING IT'S RIGHT OR WRONG, JUST SAYING IT'S MORE THAN JUST WE'RE HIDING SO THIS SO SOMEONE ELSE DOESN'T FIND OUT WHAT WE'RE DOING. >> VERY GOOD POINT. >> KEN, DO YOU HAVE A QUESTION? >> YEAH. IT'S INTERESTING, THIS TAKES OFF WHAT PAMELA WAS SAYING, A LOT OF WHAT WE'RE DOING HERE IS BECOMING INCREASINGLY RESTRICTED. FIRST TO PPP, ENHANCED PPP, WHICH IS QUITE RESTRICTED. AND THEN U.S. GOVERNMENT FUNDED, WHICH IS NOW BECOMING A SMALLER AND SMALLER PERCENTAGE OF THE AMOUNT OF FUNDING THAT'S GOING INTO BIOTECHNOLOGY RESEARCH. GIVEN ALL OF THAT, DO YOU HAVE ANY COMMENTS ON THAT PART OF IT, THE FACT THAT NO MATTER WHAT WE DO HERE, MAY BE INCREASINGLY IRRELEVANT? [LAUGHTER] >> THE BIOTECH WORLD IS MORE COMPLEX THAN IT USED TO BE. BUT I HAVE NO COMMENT OTHER THAN -- BUT YOU RAISE A GOOD POINT THAT THERE'S MANY MORE ACTORS NOW THAN THERE WERE AT THE TIME WHEN THIS POLICY WAS PUT IN PLACE. I'M NOT SURE IF I UNDERSTAND -- >> WELL, IT HAS TO DO WITH, YOU KNOW, WE'RE COMING UP WITH A SET OF WAYS, OVERSIGHT TO LOOK FOR DUAL USE. >> RIGHT. >> WHEREAS THE PRIVATE SECTOR HAS NO REASON TO ADOPT ANY OF OUR RECOMMENDATIONS IF THEY ARE NOT TAKING MONEY FROM THE U.S. GOVERNMENT. AND NOT TO MENTION FOREIGN ACTORS. >> THAT'S DEFINITELY TRUE WITH FOREIGN ACTORS. I THINK THAT'S WHY ONE OF THE REASONS I PUT THE WORLD HEALTH ASSEMBLY SAFETY THING THERE BECAUSE THAT WOULD BE MORE BROADLY APPLICABLE AND COULD MAKE SOME INROADS THERE. OR YOU HOPE. BUT I'M NOT SURE THAT THIS RESEARCH -- I HOPE SOMEBODY WILL CORRECT ME IF I'M WRONG, NOT SURE THE RESEARCH IS BEING ENGAGED AS MUCH IN THE PRIVATE SECTOR. NOT THAT I'VE DONE AN EXHAUSTIVE SURVEY BUT IN TALKING TO SOME FLU BIOLOGISTS I HAVE NOT HEARD THAT. >> I THINK PROBABLY MY COLLEAGUE ACROSS THE WAY CAN COMMENT MORE BUT YOU JUST TALKED ABOUT AN ISSUE, ESSENTIALLY THERE'S ALSO THE ISSUE OF BIOERROR, WHICH YOU JUST ENUNCIATED WHEN YOU TALKED ABOUT THE VACCINE DEVELOPMENT THING, AND THAT'S GOING ON IN THE PRIVATE SECTOR. SO YOU HAVE INADVERTENT PROBLEMS AS WELL. THAT'S SOMETHING THAT WORRIES ME ALMOST MORE. >> RIGHT. I THINK I MEAN THERE ARE A LOT OF THINGS WHEN IT COMES TO ERROR, I THINK IT NEEDS TO BE A SEPARATE CONVERSATION THAN -- BECAUSE WE ASSUME, WELL, THAT'S SOMETHING YOU CAN INVESTIGATE IN A DIFFERENT WAY AND HAVE DIFFERENT STANDARDS FOR. >> BUT I THINK IT GOES TO THE POINT OF -- THAT INDUSTRY IS ENGAGING AT A LOT OF LEVELS, SO I'M NOT SURE IT'S RIGHT TO ASSUME THAT. I DON'T THINK THEY ARE DOING ANYTHING AGGRESSIVE BUT, AGAIN, IT GOES TO -- IT'S A BROADER PICTURE MAYBE. >> AGREE WITH THAT, ABSOLUTELY. >> I WANTED TO JUST COMMENT ON THE OTHER SIDE OF THIS, I GUESS. CERTAINLY AT OUR UNIVERSITY, I SUSPECT AT MOST UNIVERSITIES, THERE'S AN INCORPORATION TUITIONAL BIOSAFETY COMMITTEE THAT LOOKS VERY CLOSELY AT RESEARCH THAT'S DONE. AND SPECIFICALLY DUAL RESEARCH OF CONCERN. SO IT'S NOT LIKE PEOPLE CAN JUST DO THESE EXPERIMENTS WITHOUT SOMEBODY -- AT LEAST IN THE ACADEMIC SECTOR, LOOKING PRETTY CLOSELY AT IT. JUST A COMMENT. >> RIGHT. THERE ARE DEFINITELY LOTS OF REGULATIONS INVOLVED IN DOING RESEARCH, PARTICULARLY WITH PATHOGENS. >> ALSO YOU MENTIONED THE HORSEPOX VIRUS, THE INVESTIGATOR WAS IN CALGARY, IN CANADA. THEREFORE-- YES, PRIVATELY FUNDED SO NONE OF OUR REGULATIONS APPLIED. >> I WONDER HOW THAT WORKS WITH COLLABORATIVE SCIENCE INTERACTIONS. I THINK MAYBE IT SOUND LIKE IT'S A REALLY NOT THE RIGHT THING TO APPLY TO THIS BUT ISSUES OF COMPETITIVENESS, OUR CAPACITY TO CONTINUE TO ATTRACT THE BRIGHTEST AND BEST, TO BE A FACTOR. THERE'S TWO PAPERS COMING OUT OF CHINA TODAY SHOWING THE CORONAVIRUS BINDS TO THE SARS RECEPTOR ALREADY. >> RIGHT. >> AND I THINK THAT THIS ISSUE OF FLEXIBILITY OR CAPACITY TO HAVE IMPACT SOME WAYS DETERMINE OUR OWN FATE AND THAT'S AN ISSUE OF SCIENTIFIC COMPETITIVENESS, KIND OF NOT -- IT'S NOT SORT OF A CLEAR -- IT'S NOT AN ITEMIZED FACTOR IN THESE ISSUES. >> ACTUALLY THAT'S WHAT THE FOCUS OF THE JASON REPORT IS. >> OKAY. >> AND BECAUSE THE QUESTION OF COLLABORATING WITH SCIENTISTS FROM OTHER COUNTRIES, AND WHETHER THE SECURITY AND ECONOMIC IMPLICATIONS, AND THEY BOTH AGREE THAT, YOU KNOW, THERE ARE THESE PROBLEMS, RESEARCH IS MISUSED FOR ECONOMIC BENEFIT, OR, YOU KNOW, TAKEN, OR YOU DIDN'T GET AS MUCH INTO THEY GOT IN SOME SECURITY ISSUES BUT THE ECONOMIC WAS THE FUEL FOR THAT REPORT. AND THEY STILL CAME OUT VERY STRONGLY, NOT CARVING OUT THIS RESEARCH, AND TO CONTINUE TO MODEL THE KIND OF SCIENTIFIC ETHICS, AND RESEARCH INTEGRITY, THEY FRAMED IT AS A RESEARCH INTEGRITY ISSUE THAT WE SHOULD CONTINUE TO DO THAT. >> I LIKE SOME OF THE ISSUES OF THE ITERATIVE REVIEW, AND YOU TALKED ABOUT THE INTERNATIONAL WORKING GROUPS, YOU KNOW, SOMEONE DID, INTERNATIONAL WORKING GROUPS, ABOUT BEST PRACTICES AND HOW YOU MOVE THAT STUFF FORWARD. I NEED TO READ ALL 5,000 PAGES TONIGHT OF ALL THESE REPORTS. I'M NOT INFORMED. [LAUGHTER] BUT THE ISSUE OF -- I BROUGHT IT UP EARLIER, INCREMENTALISM, ITERATIVE REVIEW, PROCESS OF TRANSPARENCY OR REVIEW FOR RISK THAT ALLOW FOR AN IMPORTANT THING TO MOVE FORWARD WITH THE IDEA THERE'S PLACES WHERE YOU MIGHT STOP THAT EXPERIMENT IF IT DEMONSTRATES INCREASED RISK THAT'S DEMONSTRABLE AT ANY LEVEL ALONG THE WAY THAT COULD BE DEFINED AND ITERATIVELY REVIEWED. SO IS THAT IN ANY OF THESE THOUSANDS OF PAGES OF STUFF, IS THAT A PROCESS, BECAUSE YOU KNOW THEM ALL. [LAUGHTER] THEN I HOLD YOU ACCOUNTABLE FOR KNOWING THEM ALL. [LAUGHTER] >> ACTUALLY, THAT KIND OF REMINDS ME OF THE CLINICAL TRIAL FRAMEWORK, IT MIGHT BE INTERESTING TO LOOK AT HOW THOSE ARE PERFORMED, AND ON AN INCREMENTAL MANNER, IF THERE'S ANY POTENTIAL, YOU KNOW, THIS IS CROSSING A LINE THEN WE STOP. IT'S A LITTLE BIT EASIER WHEN -- THE DECISION TREE IS CLEARER WHEN YOU'RE TALKING ABOUT BAD OUTCOMES FOR THAT SITUATION. >> MAYBE. I THINK THERE'S WAYS TO THINK ABOUT THAT, THAT MIGHT GET TO THE PLACE WHERE ULTIMATELY WE'RE FOUGHT -- NOT GOING TO AGREE, WE HAVE TO MAKE A DECISION ABOUT RISK/BENEFIT AND DOING OR NOT DOING WORKS, COMPLEXITIES WE'RE EXPERIENCING NOW IN REAL TIME, THE APPROACH MAY BE NOT IN OUR BEST BENEFIT. >> CORRECT ME IF I'M WRONG BUT I REMEMBER THAT -- (INDISCERNIBLE) I READ MANY PAGES, AT THE END OF THE DAY THE HARDEST PART ABOUT DOING THAT RISK ASSESSMENT WITH THIS KIND OF EVENT IS THAT WE DON'T REALLY HAVE -- THERE WASN'T MUCH FACTUAL DATA OF EITHER ACCIDENTS OR CERTAINLY NOT DELIBERATIVE, YOU KNOW, DELIBERATE RELEASE OF THESE TO BASE THE RISK ASSESSMENT ON. SO A LOT OF IT BECAME THIS ASKING 50 EXPERTS OR WHATEVER WHAT THEY THINK THE REAL RISK IS, AND BEING A BASIC SCIENTIST THAT CAN ALWAYS CONCERN ME. I THINK ONE OF THE THINGS THAT WE HAVE ASKED FOR, AT LEAST I ASKED FOR, WE WOULD GET ACTUALLY SOMETHING LIKE THE REHNQUIST VALUE, CLINICAL TRIALS, REPORTING STRUCTURE YOU NEED TO REPORT ACCIDENTS AND AS FAR AS I KNOW THERE IS NO POLICY OR FRAMEWORK FOR THAT. >> SO, WELL, I DON'T WANT TO REPORT ON THE GRIFFIN REPORT BUT I DO WANT TO NOTE THAT CAME OUT RIGHT BEFORE THE WINTER HOLIDAY SEASON AS WELL, SO IT WASN'T JUST 2,000 PAGES, IT CAME OUT ON A VERY BUSY TIME OF YEAR, BUT I AGREE THAT THERE WAS NOT A LOT OF DATA WHEN IT COMES TO ACCIDENTS IN THE LABORATORY, AND THAT IS PEOPLE DO NOT WANT TO REPORT FOR A LOT OF GOOD REASONS. AND SOME -- THERE'S SOME BIOSAFETY EXPERTS COMING UP IN THE FUTURE PANELS, WHO CAN TALK ABOUT SOME OF THE CHALLENGES THAT PEOPLE HAVE TO REPORT. SO THERE'S A PLACE WHERE A LOT OF TRANSPARENCY, KNOWING WHO DID IT, AND THE INSTITUTION WHERE IT WAS DONE MAY INHIBIT ACTUAL INFORMATION BEING GATHERED ABOUT THE NUMBER OF ACCIDENTS. I KNOW WHEN IT COMES TO TB, FOR EXAMPLE, IT WAS RAISED IN THE GUIDANCE FOR HOW IT WAS -- IT SHOULD BE HANDLED IN THE LABORATORY WENT UP BUT IT TOOK A LONG TIME TO GET THAT DATA BECAUSE THAT WAS AN HE CAN ANECDOTE. NOBODY WANTED TO GO ON RECORD HAVING TB ACCIDENTS IN THEIR FACILITIES SO IT INHIBITED AND PUT PEOPLE AT RISK. >> I THINK WE'RE APPROACHING THE RED LIGHT SO WE PROBABLY OUGHT TO CONCLUDE THIS SESSION. THANK YOU VERY MUCH FOR THE PRESENTATION. THANK YOU FOR KEEPING THESE DISCUSSIONS JUST IN GENERAL AND BIOSECURITY BUILT ON A SOLID SCHOLARLY FOUNDATION. THANK YOU. OUR NEXT PRESENTATION IS A PANEL DISCUSSION SO OUR PANELISTS, IF YOU COULD GO AHEAD AND BEGIN TO MAKE YOUR WAY TO THE PANEL TABLE. WE'RE LUCKY TO HAVE AN EXPERIENCED PANEL THAT'S GOING TO BE ABLE TO HIGHLIGHT MOST OF THE PERSPECTIVES AROUND THE SECURITY AND TRANSPARENCY THROUGH THIS DISCUSSION. CARRIE IS DOING A LOT OF WORK IN THIS MEETING. I THOUGHT THIS WAS THE BOARD MEMBERS THAT HAD TO DO THE WORK BUT CARRIE IS DOING DOUBLE DUTY, MODERATING, I'LL TURN IT OVER. >> THANK YOU. I APPRECIATE IT. I'M GOING TO GIVE BRIEF INTRODUCTIONS BECAUSE I WANT TO RESERVE TIME FOR CONTENT AND ENCOURAGE YOU TO LOOK AT BIOS WHICH ARE IMPRESSIVE OF THE ENTIRE PANEL. THE PANELISTS ARE JESSICA BELSER, RESEARCH MICRO BIOLOGIST, DR. TON INGLESBY, DIRECTOR OF THE CENTER FOR HEALTH SECURITY OF THE JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH, DR. VINCENT RACANELLO, PROFESSOR AT COLUMBIA UNIVERSITY DEPARTMENT OF MICROBIOLOGY AND IMMUNOLOGY, MARC LIPSITHC, HARVARD SCHOOL OF HEATHER, AND LUCIANA BORIO, SO THANK YOU, EVERYBODY. FOR PARTICIPATING, IT'S A PLEASURE TO HAVE YOU HERE. AND I'M GOING TO HAVE YOU KICK IT OFF BY ASKING EACH OF YOU, WE'LL GO DOWN THE ROW HERE, GIVE US YOUR INDIVIDUAL PERSPECTIVE ON THE QUESTION OF BALANCING TRANSPARENT AND SECURE IN THE CONTEXT OF ENHANCED P3 RESEARCH. DR. BELSER, DO YOU WANT TO START US OFF? >> GREAT. WELL, THANK YOU FOR THE OPPORTUNITY TO SPEAK TODAY. AS A MEMBER OF THE INFLUENZA DIVISION AT THE CDC, I'VE BEEN WORKING FOR OVER 15 YEARS IN HIGH CONTAINMENT LABORATORIES WITH VIRULENT AND TRANSMISSIBLE HUMAN AND ZOONOTIC INFLUENZA VIRUSES, I PERFORM RESEARCH HANDS-ON EACH DAY, I'VE LIVED AND WORK IN REAL TIME THROUGH THE FIRST ANNOUNCEMENT OF RESEARCH ACTIVITIES THAT LED TO OVERSIGHT FROM THE NSABB, RESULTING MORATORIUMS ON RESEARCH WITH DUAL USE POTENTIAL AND LIFTING OF MORATORIUMS. THROUGHOUT THESE EVENTS I'VE MAINTAINED ACTIVE RESEARCH PROGRAM WITH INFLUENZA VIRUSES CONSIDERED TO HAVE PANDEMIC POTENTIAL AND THOSE IDENTIFIED AS SELECT AGENTS BY THE U.S. GOVERNMENT. MY COMMENTS STEM FROM THIS PERSPECTIVE. BEFORE CONSIDERING ISSUES OF TRANSPARENCY AND SECURITY REGARDING THE TIMES OF RESEARCH DISCUSSED TODAY, AS THE ONLY MEMBER IN THE LABORATORY WORKING WITH VIRUSES I WANT TO STATE FIRST I FEEL SAFE WHEN PERFORMING THIS WORK. VIROLOGISTS HAVE A HEALTHY RESPECT, I'M CONFIDENT WHEN I ENTER THE LABS I'M TRAINED WITH SUFFICIENT EXPERIENCE TO WORK WITH VIRUSES THAT POSE A THREAT TO HUMAN HEALTH BUT THAT THE NUMEROUS OVERLAPPING LAYERS OF SECURITY, FACILITIES AND ENGINEERING CONTROLS AS WELL AS PRESENCE OF TRAINED COLLEAGUES I RELY ON EVERY DAY RESULT IN RESEARCH BEING PERFORMED AT THE HIGHEST STANDARD IN AN ENVIRONMENT THAT PROTECTS BOTH THE SCIENTISTS WITHIN THE LABORATORY AND THE WORLD OUTSIDE OUR AIRLOCKED DOORS. I WOULDN'T DO THIS WORK ANY OTHER WAY. THE PUBLIC HEALTH CONTRIBUTIONS RESULTING FROM RESEARCH WITH ENHANCED GAIN OF FUNCTION STUDIES ARE LEER. PREVIOUS FINDINGS SUPPORT THIS. I'M NOT HERE TO ADVOCATE FOR NEED FOR RESEARCH, STUDIES PROVIDE MANY SPECIFIC EXAMPLES OF CONTRIBUTING TO INFORMED DECISIONS PERTAINING TO AND ENHANCING PREPAREDNESS TO EPIDEMIC AND POTENTIAL PANDEMIC THREATS. I SUPPORT MECHANISMS OF OVERSIGHT AND REVIEW AND FUNDING AGENCIES THAT SUPPORT THEM FROM INITIAL DECISIONS TO CONDUCT RESEARCH THAT MAY BE CONSIDERED TO HAVE DUAL USE POTENTIAL THROUGH TO THE RESPONSIBLE DISSEMINATION TO THE SCIENTIFIC COMMUNITY AND BEYOND. HOW SHOULD WE SEARCHERS BEST CONDUCT THIS NECESSARY RESEARCH IN A RESPONSE AND TRANSPARENT MANNER? THE ANSWER LIES IN MULTITUDE OF CHECKS AND BALANCE BEFORE I OR OTHERS LIKE ME EVER STEPPED FOOT IN THE LABORATORY. THERE'S AN OBVIOUS NEED FOR ADDITIONAL SCRUTINY PRE-FUNDING APPROVAL WHEN CONSIDERING DUAL USE RESEARCH OF CONCERN. THIS SHOULD RIGHTLY BE TWO-FOLD, IF PATHOGENS REPRESENTATIVE PUBLIC HEALTH THREAT TO WARRANT MANIPULATION AND THE SCOPE OF RESEARCH PROPOSED IS SCIENTIFICALLY MERITORIOUS. ANY RISKS SHOULD BE MINIMIZED, FULL CONFIDENCE THAT THE PARTIES HAVE DEMONSTRATED CAPACITY TO CONDUCT THIS RESEARCH SAFELY AND SECURELY. THIS NECESSARY OVERSIGHT IS CURRENTLY CAPTURED AT MANY LEVELS AND SCALES. INDIVIDUALLY LABORATORYIANS HAVE BEEN TRAINED, AND PARTICIPATE IN EXERCISES AND SCENARIO DRILLS YEAR ROUND TO ENSURE WE MAINTAIN HIGH LEVEL OF PREPAREDNESS. AT THE DEPARTMENT OUR INSTITUTIONAL LEVEL BIOSAFETY AND BIOSECURITY REVIEW BOARDS ASSESS THE RESEARCH FALLING UNDER DUAL USE RESEARCH OF CONCERN. IF THIS IS SO IDENTIFIED, HHS REVIEW IS INITIATED, ASSESSING MERITS OF RESEARCH, RISKS AND BENEFITS INVOLVED AND RISK MITIGATION EFFORTS BEFORE RESEARCH IS APPROVED FOR FUNDED. IMPORTANTLY, THESE DELIBERATIONS INVOLVE BACK AND FORTH COMMUNICATION BETWEEN THE RESEARCHER AND REVIEWERS AND CAN RESULT IN MODIFICATION AND REVISION OF PLANS AND PROCEDURES, ENSURING SCIENTIFIC EXPERIMENTAL DESIGNS ARE PRUDENT, STAFF TRAINING IS COMPREHENSIVE, SUPPORT SYSTEMS ARE IN PLACE AND SECURITY AND COMMUNICATION PLANS ARE ESTABLISHED, BEFORE THE WORK EVER STARTS. THIS IS AN ADVANTAGEOUS SYSTEM, ENSURES THE FUNDING BODY IS SUPPORTING SOUND AND ETHICALLY JUSTIFIED RESEARCH, AND ALSO PROVIDES CONFIDENCE TO THE RESEARCHER THAT ALL NECESSARY SAFETY AND SECURITY BENCHMARKS ARE BEING MET FOR THIS RESEARCH TO PROCEED RESPONSIBLY. TO BE FAIR, IT CAN REPRESENT A TIME-CONSUMING AND FRUSTRATING PROCESS. AFTER 15 YEARS IN GOVERNMENT RESEARCH I KNOW MY WAY AROUND A PILE OF PAPERWORK AND AM WELL AWARE OF THE SLOW PACE OF BUREAUCRACY. BUT I ALSO KNOW THE SAFETY AND QUALITY OF RESEARCH THAT STEMS FROM LAYERS OF OVERSIGHT ARE NECESSARY AND JUSTIFIED. THESE OVERSIGHT ACTIVITIES ARE SUBJECT TO THE SAME LEVEL OF CONFIDENTIALITY AS DECISIONS PERTAINING TO RESEARCH FUNDING REQUESTS. APPLICATIONS FOR RESEARCH FUNDING IN GENERAL AND ADDITIONAL SCOPE OF DOCUMENTS REQUIRED FOR REVIEW OF STUDIES IDENTIFIED AS DUAL USE RESEARCH OF CONCERN CONTAIN SUBSTANTIAL AMOUNT OF CONFIDENTIAL AND SENSITIVE INFORMATION. THIS SPANS FROM PRELIMINARY UNPUBLISHED DATA THAT WARRANTS RESEARCH PROPOSAL IN THE FIRST PLACE TO SPECIFIC INFORMATION PERTAINING TO FACILITIES AND CONTROLS WHERE THE RESEARCH WILL BE CARRIED OUT. INFORMATION THAT IF RELEASED WIDELY COULD COMPROMISE SAFETY AND SECURITY OF THE RESEARCH ITSELF, PERSONNEL WHO CONDUCT THIS WORK AND FACILITIES WHERE THIS WORK TAKES PLACE. I DO THINK THERE IS ROOM FOR IMPROVEMENT IN HOW STUDIES ARE IDENTIFIED PUBLICLY AND SEE NO HARM IN CLEARLY IDENTIFYING PUBLICLY THOSE FUNDED PROJECTS WHICH HAVE SUCCESSFULLY PASSED THIS LEVEL OF REVIEW. I WELCOME A DISCUSSION ON HOW BEST TO BALANCE THIS NEED FOR TRANSPARENCY TO THE PUBLIC WHILE MAINTAINING CONFIDENTIALITY OF GRANT SUBMISSION AND IDENTITY OF INDIVIDUALS INVOLVED. WE'LL BE HEARING FROM OTHER PANELISTS NEED FOR CONTINUED EVALUATION OF HOW THESE RESEARCH ACTIVITIES CAN BE BEST COMMUNICATED TO OTHER SCIENTISTS AND THE GENERAL PUBLIC, AND WAYS ALL RESEARCH ACTIVITIES WITH ENHANCED POTENTIAL PANDEMIC PATHOGENS CAN BE SUBJECTED TO LEVEL OF OVERSIGHT I'VE DESCRIBED HERE REGARDLESS OF FUNDING SOURCE. HE SUPPORT BOTH EFFORTS AND AGREE WITH NEED FOR REVIEW. AT THE END OF THE DAY, I HOPE WE CAN ALL CONCUR RESEARCH ACTIVITIES REPRESENT AN IMPORTANT COMPONENT TO PUBLIC HEALTH, AND STRIKING THE RIGHT BALANCE ON THESE ISSUES IS OF PARAMOUNT IMPORTANCE FOR ALL PARTIES INVOLVED. THANK YOU. >> THANK YOU. DR. INGLESBY? >> THANKS SO MUCH, CARRIE. OKAY. SO, I'M GOING TO SPEAK ABOUT THE COMMENTARY REFERENCED EARLIER IN YOUR PACKETS AS MEMBERS, OTHERWISE ONLINE, WE PUBLISHED IT YESTERDAY. ALSO ANOTHER ARTICLE REFERENCES, WASHINGTON POST COMMENTARY WHICH MARK AND I WROTE LAST YEAR, ONE YEAR AGO TODAY, CONCERNED THAT SPECIFIC EXPERIMENTS HAD BEEN RESTARTED UNDER THIS HHS FRAMEWORK BUT HAD NOT BEEN ANNOUNCED PUBLICLY OR DESCRIBED OR JUSTIFIED. SO THOSE ARE THE TWO THINGS IN YOUR PACKETS REFERENCED EARLIER. NEXT SLIDE. THE FIRST BULLETS ARE THE DEFINITIONS THAT COME FROM FEDERAL GOVERNMENT POLICY, YOU'VE SEEN THEM THREE TIMES TODAY. THE LAST IS IMPORTANT TO SAY THAT JUST TO MAKE IT SIMPLE. WE'RE TALKING ABOUT HERE THE GOVERNMENT FUNDING AND APPROVAL PROCESS FOR RESEARCH THAT IS INTENDED TO CREATE TRANSMISSIBLE VIRULENT AGENTS, WHICH IF SOMETHING GOES WRONG EITHER BY ACCIDENT OR ON PURPOSE, COULD INITIATE EPIDEMIC OR PANDEMIC, A VERY SPECIFIC AREA OF RESEARCH, NOT ALL DUAL USE RESEARCH, NOTHING TO DO WITH BROADER CORONAVIRUS RESEARCH AGENDA. I'VE HEARD ALIGNING OF THE TWO TODAY. MARK AND I FOR EXAMPLE ARE VERY SUPPORTIVE AND STRONG ADVOCATES FOR CORONAVIRUS SCIENCE, HAVE BEEN FOR YEARS, THIS HAS TO DO WITH A VERY SMALL SINGLE DIGIT NUMBER OF EXPERIMENTS PROPOSED OVER THE YEARS, AT SOME POINT DOUBLE DIGIT, REDUCED AFTER FURTHER REVIEW, A SMALL NUMBER OF EXPERIMENTS, IT IS NOT ALL DUAL USE. WE'RE VERY PRO SCIENCE AROUND CORONAVIRUS. SO I THINK WHAT WE'RE ADVOCATING FOR IN THIS COMMENTARY, MORE BROADLY, IS TO ADHERE TO THE GUIDANCE THAT WAS WRITTEN EARLIER, WHICH IS TO SAY TO THE MAXIMUM EXTENT POSSIBLE AGENCIES THAT -- REVIEW MECHANISMS SHOULD PROVIDE TRANSPARENCY, THERE WAS NO PUBLIC DESCRIPTION AT THE TIME OF JANUARY OF 2019 WHEN INDIVIDUAL EXPERIMENTS WERE DISCLOSED AFTER A REPORTER ASKED THE GOVERNMENT FOR DETAILS. SO THE GOVERNMENT DID NOT DISCLOSE THOSE INDIVIDUAL EXPERIMENTS RESUMED. THEY DISCLOSED IN 2017 THAT THE WORK WOULD BE RESUMED, BUT SPECIFIC EXPERIMENTS THAT STARTED A YEAR LATER WERE ANNOUNCED VIA REPORTER FROM "SCIENCE" GETTING A TIP AND CALLING THE GOVERNMENT. THAT DOESN'T SEEM LIKE THE RIGHT PROCESS TO US AND THINK IT SHOULD CHANGE. THE POLICY DOES COMMIT TO BALANCE OF PERSPECTIVES. IT WAS GOOD TO HEAR CHRIS DESCRIBE THIS PROCESS PUBLICLY, IT'S NOT DESCRIBED PUBLICLY ELSEWHERE AND WOULD BE USEFUL TO DESCRIBE IT. IT SHOULD BE DISCLOSED WHO IS PART OF THIS PROCESS SO THAT'S PART OF THE PUBLIC RECORD IN THE WAY THAT NIH ROSTERS ARE DISCLOSED. WE'RE NOT ASKING FOR THINGS EXTRAORDINARY, FOR THE MOST PART. IN THIS CASE, I BELIEVE THE PUBLIC SAFETY SHOULD OUTWEIGH CONCERN ABOUT TRADE SECRETS. I KNOW THAT'S A DEBATE THAT YOUR COMMITTEE WILL HAVE, BUT PAM STARTED TO BRING IT UP, AND OTHERS HAVE. AGAIN, THIS IS NOT ABOUT ALL OF THE DISCUSSIONS IN DUAL USE RESEARCH. EVEN THIS CONVERSATION TODAY IS INTENDED TO SLIP IN AND OUT OF THE BROAD DUAL USE DISCUSSIONS. THAT'S A MORE COMPLICATED DISCUSSION, THIS IS A PRETTY SPECIFIC ONE TODAY ABOUT P3CO POLICY, A SMALL NUMBER OF EXPERIMENTS THAT ARE GOING THROUGH THE PIPELINE OR PROPOSED. IDEALLY I BELIEVE IT SHOULD INCLUDE OUTSIDE SCIENTISTS WITH EXPERTISE THAT'S NECESSARY. FOR EXAMPLE SOMEONE FROM JOHN'S SHOP AT MERCK COULD BE A GREAT ADDITION IF THEY ARE NOT ALREADY INVOLVED. SOMEONE, A LOT OF CLAIMS ABOUT BENEFIT OF THIS WORK RELATE TO ITS VALUE TO VACCINE DEVELOPMENT, BUT TYPICALLY OVER THE LAST EIGHT YEARS WE'VE HAD FEW IF ANY VACCINE DEVELOPERS AT MEETINGS TAKING A POSITION. WE SHOULD HAVE THEM INVOLVED IN THEY ARE PART OF THE JUSTIFICATION OF THIS WORK. SIMILARLY PEOPLE WHO USE JUSTIFICATION IT WILL INCREASE SURVEILLANCE I AGREE WITH WHAT JESSICA JUST SAID BUT I DON'T AGREE WITH THE KIND OF ASSERTION THAT THE BENEFITS OF THIS WORK ARE WIDELY PROVEN. I THINK THAT'S SOMETHING THAT YOUR COMMITTEE SHOULD THINK ABOUT AND LOOK AT ITSELF, MAKE ITS OWN JUDGMENTS IN MY VIEW I DON'T THINK IT'S CLEAR ABOUT THE CONCRETE BENEFITS THAT HAVE BEEN ASSERTED. I ALSO THINK THAT IN OTHER CASES OF LIFE SCIENCE BIOSAFETY ISSUES SUCH AS BOSTON WHEN THE BL4 LAB WAS PUT UP THERE WAS A DEBATE ABOUT IT PUBLICLY AND INCLUSION OF THE STATE PUBLIC HEALTH AUTHORITIES, THAT PROCESS OVERALL WAS REALLY MESSY AND TINT -- SHOULDN'T BE MODELED, BUT PUBLIC HEALTH SHOULD BE INVOLVED. DECISION-MAKING CRITERIA AGAIN NO PUBLIC INFORMATION RELEASED ABOUT PARTICULARS OF EXPERIMENTS, WHY THEY ARE FUNDED. THERE WAS DEBATE BEFORE THE PAUSE IN FUNDING BACK IN 2017 BUT PRESUMABLY THE EXPERIMENTS HAVE EVOLVED IN SOME WAY. THERE'S BEEN NEW DEBATE. WHAT ARE THE CRITERIA WOULD BE USEFUL TO KNOW. THERE'S NO BASIS TO UNDERSTAND HHS DECISIONS IF YOU HAVE AN INTEREST FROM THIS IN THE PUBLIC SECTOR. AND SO TO PUT A POINT ON IT IT WOULD BE USEFUL, AND I THINK IMPORTANT FOR THE U.S. GOVERNMENT TO SAY PRECISELY WHAT IS IT WE THINK WE'RE GOING TO BENEFIT, AS MARK SAID BEFORE IT MAY BE THIS IS A FUNDAMENTAL SCIENCE CONTRIBUTION, OKAY, THAT SHOULD BE PRESENTED. IF IT'S PARTICULAR ABOUT VACCINE DEVELOPMENT BE SPECIFIC AND NOT SAY THIS WILL HELP VACCINE DEVELOPMENT BROADLY IN SOME WAY TO BE DESCRIBED LATER. WHAT DOES THE GOVERNMENT SAY ABOUT RISK? I'VE HEARD SENIOR GOVERNMENT OFFICIALS SAY THINGS LIKE ALL INFECTIOUS DISEASE RESEARCH HAS RISKS. THAT'S NOT A GOOD ANSWER TALKING ABOUT LARGE SCALE POTENTIAL CONSEQUENCE. IF THE GOVERNMENT WERE MORE SPECIFIC ABOUT BENEFITS AND RISKS, PEOPLE COULD JUDGE ANALYSIS. IT MAY BE EXPERIMENTS ARE WORTH PURSUING BUT LET'S EXPLAIN THE JUSTIFICATION FOR IT BEFORE THEY ARE PURSUED. FINALLY THE INFORMATION ABOUT THIS JUST LIKE IN DISCUSSIONS ABOUT ENVIRONMENTAL IMPACT ASSESSMENTS, ET CETERA, SHOULD BE MADE PUBLISH BEFORE THE WORK IS DONE. IS HIGH LEVEL APPROVAL IS IMPORTANT IN THE WAY ATTENTION FOR THE RAC GUIDELINES AROUND RECOMBINANT OR SYNTHETIC NUCLEASE MOLECULES. IN RAC, THAT REQUIRES THE APPROVAL OF THE NIH DIRECTOR OR HAS REQUIRED. IT MAY HAVE EVOLVED. LATELY THERE HAVE BEEN CHANGES TO RAC BUT THAT CHANGE LESS CONSEQUENTIAL THAN CHANGES REQUIRED SENIOR LEVEL POLITICAL APPROVAL. IN THIS CASE IT'S NOT CLEAR WHERE APPROVAL IS HAPPENING WITHIN THE GOVERNMENT, I HEARD TODAY IT WAS CHRIS AND I RESPECT CHRIS BUT THINK IT'S NOT FAIR TO CHRIS TO ASK HIM TO CARRY THE SHOULDER -- SHOULDER THE BURDEN OF THIS KIND OF DECISION AND I THINK IT SHOULD BE SOMEBODY WHO HAS POLITICAL AUTHORITY WITHIN HHS TO SIGN OFF ON IT. AS A SEPARATE MATTER ORIGINAL GUIDANCE FOR P3CO COMMITTED TO INTERNATIONAL ENGAGEMENT AROUND THESE ISSUES. THE U.S., IT MAY BE THE U.S. IS THE ONLY GOVERNMENT FUNDING THIS. WE'VE HEARD IN PAST YEAR CHINA AND WUHAN HAD DONE WORK ON FLU AROUND THIS. THAT'S OLD NEWS. BUT WE DON'T HAVE INTERNATIONAL CONSENSUS ABOUT HOW TO OPERATE HERE. AND AS I THINK CHRIS WAS SAYING OR MAYBE CARRIE WAS SAYING, THAT SINCE WE ARE LEADING THE EFFORTS HERE OR FUNDING MORE THAN ANYONE ELSE, IT SHOULD BE INCUMBENT ON US TO INITIATE OR CONTINUE, HAS BEEN INITIATED BUT STOPPED, ANY DISCUSSION ABOUT HOW WE SHOULD PROCEED INTERNATIONALLY. DON'T WE WANT OTHER COUNTRIES TO OPERATE UNDER THE SAME RULES THAT WE DO? WOULD WE BE UPSET FOR EXAMPLE IF WE FOUND OUT TODAY THAT SOME OTHER COUNTRY WAS DOING CORONAVIRUS RESEARCH TO CREATE MORE PATHOGENIC OR MORE TRANSMISSIBLE CORONAVIRUS IN THE ABSENCE OF CLEAR SET OF INTERNATIONAL STANDARDS, AND I WOULD SAY TO THAT END STANDARDS SHOULD LOOK LIKE THIS BUT FLESHED OUT IN GREAT DETAIL, EXPERIENCE WITH DANGEROUS PATHOGENS OF TYPE UNDER STUDY, EXCEPTIONAL TRAINING, BIOSECURITY AWARENESS AND NATIONAL POLICY FRAMEWORK THAT IS STUDYING THESE ISSUES, RISKS, BENEFITS. IN SUMMARY, WHAT WE PROPOSE TO DO QUITE SPECIFICALLY ABOUT THE CHANGE IN POLICY. I'LL TAKE QUESTIONS WITH THE PANEL. >> WE'LL CONTINUE DOWN THE LINE. >> IN 1981 TOGETHER WITH DAVID BALTIMORE WE PRODUCED THE FIRST INFECTIOUS DNA COPY OF THE POLIO VIRUS IS, BASIS FOR SUBSEQUENT MODIFICATION INCLUDING GAIN OF FUNCTION AND THOSE WITH DUAL USE. OVER 40 YEARS I'VE SPENT A GOOD DEAL OF TIME THINKING ABOUT THE IMPLICATIONS OF OUR 1981 FINDINGS, STRONGLY BELIEVED SCIENTISTS SHOULD NOT BE TOLD WHAT EXPERIMENTS THEY CAN NOT DO. RATHER THEY SHOULD BE REQUIRED TO CARRY THEM OUT SAFELY. ABOUT TWELVE YEARS AGO BECAME INTERESTED IN DOING -- COMMUNICATING SCIENCE TO THE PUBLIC, LIKE BLOGS, PODCASTS, VIDEOS, SOCIAL MEDIA. I AMASSED A SUBSTANTIAL FOLLOWING OF INDIVIDUALS, MANY WITHOUT SCIENCE BACKGROUNDS WHO HAVE AN INTEREST IN MICROBES AND HOW THEY IMPACT HUMAN HEALTH. AVIAN H 5N 1 STUDIES IN 2011, YOU'VE HEARD ABOUT THESE INVOLVED ADAPTING THE VIRUS TO AEROSOL TRANSMISSION AMONG FERRETS. TRANSMISSION AND VIRULENCE ARE TWO PROPERTIES, NOT THE SAME THING. IT KEEPS GETTING CONFLATED. H5N1 BE LETHAL BUT DOESN'T TRANSMIT BY AEROSOL, A GOOD INCIDENT TO FRAME A DISCUSSION ABOUT TRANSPARENCY BECAUSE THAT INCIDENT IN MY VIEW EPITOMIZED WHAT SHOULD NOT BE DONE. BOTH THIS COMMITTEE, NSABB, POPULAR AND SCIENTIFIC PRESS AND SCIENTISTS PORTRAYED RESULTS WITH LANGUAGE OF DOOMSDAY. THE CHAIR SAID HE CAN'T THINK OF ANOTHER PATHOGENIC ORGANISM AS SCARY, EXPERIMENT SHOULD NOT BE DONE, THE VIRUS COULD CHANGE HISTORY, "NEW YORK TIMES" SAID THE RESEARCH SHOULD NEVER HAVE BEEN UNDERTAKEN. THE RESULTS WERE NEVER TRANSMITTED EITHER TO SCIENTISTS, THE PRESS OR THE PUBLIC BECAUSE PUBLICATION OF MANUSCRIPTS WAS HALTED. A KEY FINDING WAS IGNORED. THE ADAPTATION OF THESE VIRUSES TO RESPIRATORY TRANSMISSION AMONG FERRETS ABOLISHED LETHALITY, IGNORED BY EVERYONE, INCLUDING APPARENTLY THIS COMMITTEE. I WAS ONE OF THE FEW SCIENTISTS WHO PUBLICLY PORTRAYED THE WORK ACCURATELY AND DEFENDED IT. MY READERS AND LISTENERS WANTED TO KNOW WHO WAS RIGHT, ME OR THE NAYSAYERS. CLEARLY THEY WERE SCARED AND CONFUSED. HAD THE NSABB FROM THE ONSET COMMUNICATED THE FACTS THAT AEROSOL TRANSMITTED VIRUSES WERE NOT LETHAL, THE ENTIRE DIALOGUE MIGHT HAVE BEEN DIFFERENT. THE STORY EMPHASIZEs THERE MUST BE TRANSPARENCY WILL THE RESEARCH SO THE PUBLIC CAN UNDERSTAND IT. I DISAGREE THAT THE PUBLIC DOESN'T WANT DATA. MY LISTENERS WANT DATA, TO KNOW WHAT'S GOING ON, TO HEAR US TALK ABOUT IT. WHILE DECIDING TO PUBLISH THEY SHOULD HAVE SAID WE'VE GOT AEROSOL TRANSMISSION BETWEEN FERRETS BUT DIDN'T KILL THEM BUT THEY DIDN'T DO THAT. ANOTHER QUESTION WAS WHETHER BENEFITS JUSTIFY THE RISK WHICH WE'VE TALKED ABOUT. NO TRANSPARENCY FROM THE COMMITTEE, ONCE AGAIN. FOCUS BECAME SOLELY IDENTIFICATION OF ACID CHANGES IN H-A PROTEIN OF THE VIRUS THAT ENABLE AEROSOL TRANSMISSION, AND VALUE IN EPIDEMIOLOGIC STUDIES. THAT'S NOT THE REAL VALUE OF THE WORK BUT IT WAS IGNORED. THE REAL VALUE IS THE EXPERIMENTS PROVIDE STRUCTURAL INFORMATION OF WHAT YOU NEED FOR TRANSMISSION. IT DOESN'T HELP YOU PREDICT THE NEXT PANDEMIC, DOESN'T HELP YOU MAKE A VACCINE. IT'S FUNDAMENTAL SCIENCE ABOUT WHAT MAKES OR DOESN'T MAKE A VIRUS TRANSMIT. ALL OF THAT IS IGNORED AND THAT REALLY BOTHERS ME AS A BASIC SCIENTIST. THE OTHER TRANSPARENCY ISSUE I WANT TO COMMENT ON IS HOW THE DUAL USE PROPOSALS ARE REVIEWED. IN 2019, DECISION WAS MADE TO ALLOW RESUMPTION OF AEROSOL TRANSMISSION EXPERIMENTS, AND AGAIN WE HAVE A LOT OF PRESS ON THAT AS YOU HEARD TODAY, KAISER WROTE STUDIES THAT MODIFY BIRD FLU VIRUSES IN WAYS TO MAKE THEM RISKY TO HUMANS, RESEARCH THAT COULD MAKE VIRUSES MORE DANGEROUS SET TO RESUME, AND THOSE ON EITHER SIDE OF ME WROTE THE U.S. IS FUNDING DANGEROUS EXPERIMENTS I DOESN'T WANT YOU TO KNOW ABOUT. VIRUS TRANSMISSION, THE ACQUISITION OF TRANSMISSION, ABOLISHED PATHOGENESIS OF THE VIRUS. NOBODY MENTIONS THAT BUT ME. SUBSEQUENTLY MORATORIUM WAS IMPOSED ON GAIN-OF-FUNCTION RESEARCH INCLUDING H5N1, MERES, SARS, CORONAVIRUS. PROCEDURES WERE PUT IN PLACE TO REVIEW THESE EXPERIMENTS, RISK/BENEFIT WAS DONE, AND AS FAR AS I COULD TELL THIS, TO ME, WAS TRANSPARENT. THE STUDY SECTION DELIBERATIONS NEVER ARE. AND LET ME END BY SAYING I WROTE A LETTER TO THE "NEW YORK TIMES" ABOUT THAT TIME, I WROTE IN MY OPINION THE PROCESS OF ASSESSING RISKS AND BENEFITS OF GAIN OF FUNCTION HAS BEEN TRANSPARENT. AS A SCIENTIST, I'M SATISFIED THE CORRECT STEPSING HAVE BEEN -- STEPS HAVE BEEN TAKEN. NORMAL IS NOT NEWS, THAT LETTER WAS NOT PUBLISHED. I'M SATISFIED WITH THE PROCEDURE. YOU HAVE TO DEAL WITH THE FACT THAT IF YOU DISSEMINATE INFORMATION THROUGH THE PRESS, IT WILL BE MISCONSTRUED. I THINK THE BEST THING YOU CAN DO IS GO THROUGH SCIENTISTS ANNUAL PEOPLE WHO -- AND PEOPLE WHO KNOW THE CONSEQUENCE. TRANSPARENCY IS THE KEY. AS WE CAN SEE FROM THE VIRUS EMERGING IN CHINA, NATURE IS BEST AT PRODUCING DANGEROUS PATHOGENS. THANK YOU. >> THANK YOU. >> THANK YOU. I'D LIKE TO CORRECT TWO SMALL POINTS FROM THE PREVIOUS THING. WE DID NOT WRITE THAT HEADLINE IN THE U.S. GOVERNMENT IS FUNDING WORK IT DOESN'T WANT YOU TO KNOW ABOUT. THAT WAS THE HEADLINE WRITERS, IT WAS NOT OURS. WE HAD A MUCH MORE INNOCUOUS TITLE. THE SECOND IS MORE SERIOUS, AS A REMINDER, 1918 FLU HAD A CASE FACILITY RISK OF 2%. THERE'S NO EVIDENCE FROM TEN FERRETS, ZERO DIE, THAT DOES NOT MEAN THE RISK IS CLOSE TO BELOW 2%. SO I DON'T THINK THAT'S ENCOURAGING AS IT OTHERWISE WOULD HAVE BEEN. I WANT TO SPEAK ABOUT WHAT'S MOSTLY THE SECOND HALF OF THE ARTICLE THAT TOM AND I PUBLISHED RELATED TO FUNDING AND PUBLISHING. AND RESPONSIBLE COMMUNICATION. EVERYBODY I TALKED TO, ESPECIALLY THE YOUNGE THEY ARE, BUT REALLY EVERYBODY IS IN FAVOR OF OPEN SCIENCE TO MAKE SCIENCE WORK BETTER, FUNDERS INCREASINGLY INSIST ON IT INCLUDING NIH AND JOURNALS, I'M A MEMBER OF BOARDS LEADING THAT CHARGE AND BELIEVE IN THAT. I WANT TO HIGHLIGHT THERE'S A CONFLICT THERE WITH BIOSAFETY AND BIOSECURITY. IF YOU DO WORK WHICH YOUR FUNDERS APPROVE AND SAY IS SAFE, IN YOUR HANDS, IN YOUR FACILITY, AND YOUR FUNDER OR PUBLISHING COMPANY REQUIRES THAT YOU SHARE YOUR REAGENTS, THAT CREATES A CONFLICTING OBLIGATION THAT YOU'RE NOW ASKED TO SHARE THE PRODUCT OF THAT WORK WHICH MAY BE SAFE IN YOUR HANDS WITH ANYBODY WHO ASKS FOR THEM. AND MAYBE IT'S NOT ANYBODY BUT CLOSE TO ANYBODY. AND SO I DON'T KNOW THE RESOLUTION. I'LL SUGGEST A POSSIBLE ONE BUT THE POINT IS WITH EVEN A PERFECT SYSTEM OF CONTROL OF EXPERIMENTS AT THE FUNDING STAGE, THE MERE POSSESSION OF THESE BY BAD ACTOR OR BY LESS SAFE SCIENTIST IS A PROBLEM. I THINK IT'S A SOLVABLE ONE. AND THE MANDATE IN THE P3CO POLICY TO DEVELOP STANDARDS FOR RESPONSIBLE COMMUNICATIONS SUGGESTS POTENTIAL WAYS FORWARD. ONE POSSIBILITY THAT WE PROPOSE, AND I THINK THERE'S LOTS OF ROOM FOR DISCUSSION, JOURNAL AND FUNDER ACCESS POLICIES SHOULD HAVE SPECIAL PROVISIONS IN THE CASE OF ENHANCED PPPs OR AGENTS THAT PROPOSE ACCIDENTAL RISK. THE DETAILS REQUIRE SOME DISCUSSION. WHAT WOULD THE CONDITIONS BE FOR SHARING THESE REAGENTS, WOULD IT JUST BE NOT SHARED OR WOULD IT BE THAT YOU NEED SOME KIND OF CERTIFICATION, AND MAYBE ONE MODEL IS THE AMERICAN TYPE CULTURE COLLECTIONS FORM 62 WHICH IS CERTIFICATION IF YOU WANT TO GET CERTAIN KINDS OF PATHOGENS FROM THEM, THAT YOU HAVE TO CERTIFY YOU KNOW WHAT YOU'RE DOING AND ACCEPT RESPONSIBILITY. BUT THE DETAILS REQUIRE WORK. WE ALSO WANT TO HIGHLIGHT THE ISSUE OF NON-U.S. GOVERNMENT FUNDERS AND THE ROLE OF PUBLISHERS IN PARTICULAR. SO AS HAS BEEN NOTED BEFORE, THE P3CO POLICY APPLIES TO U.S. GOVERNMENT FUNDING. BUT THERE ARE NO OBLIGATIONS FOR NON-U.S. GOVERNMENT FUNDERS. AND PUBLISHERS HAVE ESSENTIALLY NO POLICIES ON BIOSAFETY THAT I'VE BEEN ABLE TO FIND, AND NATURE IS CLOSE TO UNIQUE IN HAVING ONE ON BIOSECURITY. AND IN PARTICULAR, TO AGAIN EMPHASIZE THE POINT TOM MADE, THIS IS RELEVANT PARTICULARLY IN THE VERY SMALL FRACTION OF STUDIES, THE TWO THAT HAVE BEEN APPROVED PERHAPS, BY THE P3CO PROCESS, AND THE DOZEN OR SO THAT WERE SUBJECT TO THE FUNDING MORATORIUM, WE'RE NOT TALKING ABOUT BLOCKING OR SLOWING THE VAST, VAST MAJORITY OF RESEARCH. SO WHAT COULD BE DONE ABOUT THIS? AND THE QUESTION WAS RAISED, ARE WE JUST BEING IRRELEVANT, BY RESTRICTING U.S. GOVERNMENT FUNDING? AND I THINK THAT'S A SERIOUS QUESTION. AND IT'S A QUESTION I'VE ASKED AS WELL. SO HERE IS ONE IDEA FOR A SOLUTION. AGAIN, OPEN FOR LOTS OF DISCUSSION. PERHAPS THE'S GOVERNMENTS AS PART OF THE P3CO POLICY COULD MAKE A RECOMMENDATION OF BEST PRACTICES WHICH WOULD APPLY TO JOURNALS AND TO PUBLISHERS AND TO FUNDERS. AND THE FUNDERS WOULD BE ASKED TO OR RECOMMENDED TO ADOPT A POLICY SIMILAR TO THE ONE THAT HHS ADOPTS, OR AT LEAST THE ONE THAT WE RECOMMEND THAT THEY ADOPT WITH SOME ENHANCEMENTS, WHICH IS THAT FUNDING ENHANCED PPP EXPERIMENTS FOLLOWS ONLY IF AN INDEPENDENT TRANSPARENT REVIEW INVOLVING APPROPRIATE EXPERTISE FINDS RISKS OUTWEIGH BENEFITS. SO IN OTHER WORDS, IT SHOULD BE RECOMMENDED IF WE'RE GOING TO DO THIS AT THE U.S. GOVERNMENT WE THINK OTHERS SHOULD DO IT. IT'S NOT A LAW. IT'S A RECOMMENDATION. AND PUBLISHERS WOULD BE LAST LINE OF DEFENSE HOPEFULLY NOT USED VERY MUCH BECAUSE THAT'S NOT THE BEST PLACE WHICH TO DO IT. BUT SIMILAR TO HUMAN SUBJECT PROTECTION REQUIREMENTS COULD ESTABLISH POLICIES THEY WOULD POSSIBLE OF PUBLISH IF THE FUNDER HAS SHOWN SOME KIND OF DOCUMENTATION OF THIS REVIEW. I THINK PRE-PRINTS ARE THE POTENTIAL ACHILLES HEEL OF THIS. NOT ENTIRELY BECAUSE PRE-PRINT FROM MOST ACADEMIC SCIENTISTS IS NOT THE ULTIMATE INCENTIVE BUT RATHER HIGH PROFILE PUBLICATION SO I THINK IT WILL MATTER IN MAJOR JOURNALS DO THIS EVEN IF PRE-PRINT PUBLISHERS DON'T. BUT IF SOMEBODY FOR WHATEVER REASON WANTS TO GET INFORMATION OUT IT WOULD BE CHALLENGING FOR THE PRE-PRINT PUBLISHERS BUT WE NEED TO ENGAGE WITH THEM AS WELL. THANK YOU. >> THANK YOU FOR THE INVITATION. I'VE BEEN ASKED TO PROVIDE PERSPECTIVES, MY EXPERIENCE WORKING AT FDA, ACTING CHIEF SCIENTIST AND SUBSEQUENTLY AT THE WHITE HOUSE NATIONAL SECURITY COUNCIL AS DIRECTOR FOR MEDICAL AND BIODEFENSE PREPAREDNESS POLICY. AND I NOW WORK AT INKUTEL, A NOT-FOR-PROFIT STRATEGIC INVESTMENT FIRM, THE MOST FUN JOB EVER. THAT WORKS TO SUPPORT AND FUND TECHNOLOGIES, INCLUDING BIOTECHNOLOGIES, THAT SUPPORT THE MISSION OF THE UNITED STATES INTELLIGENCE AND NATIONAL SECURITY COMMUNITIES. SO I HAVE A FRONT-ROW SEAT TO THE MOST EXCITING TECHNOLOGIES OVER THE COUNTRY. I THINK WE HAVE CONSENSUS THAT THIS TYPE OF RESEARCH IS NOT WHAT I CALL SHOW AND TELL. THAT IT SHOULDN'T BE DONE FOR THE PURPOSES OF ANSWERING CURIOSITY QUESTIONS. AND THERE MUST BE STRONG RATIONALE AND REASON FOR UNDERTAKING IT. AND INCLUDING THE PROSPECT OF BENEFIT OUTWEIGH THE RISKS. WE KNOW THAT IT'S UNCLEAR IN THE BEGINNING WHEN WE EMBARK ON THESE TYPES OF EXPERIMENTS BUT THE PROSPECT OF BENEFIT NEEDS TO OUTWEIGH THE RISKS. AND WE KNOW THAT EVERYBODY NEEDS TO WORK TO MINIMIZE ANY POTENTIAL RISK, WHETHER ACCIDENTAL OR -- SO I DON'T THINK THERE'S DISAGREEMENT ON THAT. AND THERE'S A QUESTION ABOUT THE REVIEW PROCESS AND TRANSPARENCY, AND IT'S MY BELIEF IT'S REALLY CRITICAL AND IMPERATIVE THE REVIEW AND DECISIONS, SO THE WHOLE PROCESS AREN'T RISKIER EXPERIMENTS BE DONE IN CAREFUL MANNER BY EXPERTS. WE CAN DEBATE THIS, WHAT DOES THAT MEAN, AND THE FRAMEWORK IS MY EXPERIENCE WITH THE FDA. REVIEWS PROCESS AND RESEARCH PROPOSALS HAVE TO BE OPEN TO PUBLIC SCRUTINY. AT THE FDA, THE PROCESS IS VERY WELL KNOWN TO THE PUBLIC. VERY WELL ESTABLISHED. AND THE SPECIFIC SCIENTIFIC RATIONALE TO SUPPORT FOR NOT AN APPROVAL ONCE A DECISION IS ACHIEVED IT'S KNOWN TO THE PUBLIC. ALL THE CORRESPONDENCE IS KNOWN TO THE PUBLIC. THERE'S BEEN A LONG STRING OF CONTROVERSIAL APPROVALS ASSOCIATED WITH THE FDA, BUT THAT'S ALL PUBLIC. IF ANY OF YOU HAVE QUESTIONS THAT CORRESPONDENCE COULD BE RIVETTING READING, I'LL BE GLAD TO SHARE A BIBLIOGRAPHY AFTER THIS MEETING BUT AGAIN IT'S ALL THERE. ENED THEN THERE'S ALSO EXPECTATION REVIEW IS DONE BY EXTRAORDINARILY EXPERT PEOPLE WHO REALLY UNDERSTAND THEIR FIELDS. AND ARE FREE OF CONFLICT OF INTEREST REGARDING THE DECISION. THAT MAY SERVE AS AN IMPORTANT MODEL FOR HOW THIS REVIEW FOR THIS TYPE OF RESEARCH OUGHT TO BE UNDERTAKEN. THE SECOND POINT HAS TO DO WITH PUBLICATION DISSEMINATION OF RESEARCH FINDINGS ITSELF. I'M CONCERNED SOMETIMES THE DISCUSSIONS END UP BEING SECURITIZED, AND WE HEAR THINGS SUCH AS RESPONSIBLE COMMUNICATION, PARTIAL DISCLOSURE, BUT ULTIMATELY WE'RE TALKING ABOUT SOME FORM OF CONTROL OF INFORMATION. AND TO PREVENT IT I GUESS THE GOAL FROM INFORMATION GETTING INTO BAD PEOPLE'S HANDS, BUT I THINK IT MISSES THE POINT THAT THE STARTING POSITION FOR US TO UNDERTAKE EXPERIMENTS IS BECAUSE WE BELIEVE THEY ARE EXTRAORDINARILY IMPORTANT FOR THE BENEFIT OF HUMANITY. IT MAY BE A VERY HIGH LEVEL GOAL BUT THAT'S THE CONSTRUCT, THESE ARE ESSENTIAL EXPERIMENTS THAT OUGHT TO BENEFIT HUMANITY. AND THAT THEY HELP US UNDERSTAND RISKS AND DEVELOP MECHANISMS TO COUNTER THEM. SO IN THIS CASE I THINK TRANSPARENCY IS SECURITY. THE LEST TRANSPARENT WE ARE, THE LESS SECURE WE ARE. IT'S TRUE THERE ARE BAD ACTORS IN THE WORLD. AND THE BAD ACTORS OBSERVING THIS VERY SMALL PIECE OF SCIENTIFIC ENDEAVORS SADLY IS LIKELY A VERY SMALL NUMBER BECAUSE DENOMINATOR IS SO LARGE, IF THAT MAKES SENSE. WE CAN GET TIED UP IN KNOTS WHAT TO DISCLOSE, BUT WE HAVE TO THINK CAREFULLY HOW MUCH SAFER WE ARE BY BEGINNING TO LOOK FOR WAYS TO CENSURE DISSEMINATION OF INFORMATION, ESPECIALLY IN PRACTICE. WE CAN CONTEMPLATE THAT BUT IN PRACTICE WE KNOW SHARING OF FUNDAMENTAL SCIENTIFIC KNOWLEDGE THAT IS CRITICAL, AGAIN THAT'S THE ASSUMPTION HERE, THIS TYPE OF SCIENCE IS CRITICAL, WE KNOW THAT THE SHARING OF INFORMATION IS WHAT SERVES THE BROADER SCIENTIFIC COMMUNITY AND SCIENTIFIC PROGRESS. I SEE OTHER RISKS TO RESTRICTION. I DON'T EVEN KNOW THAT NOT SHARING CERTAIN MATERIALS OR METHODS MAKES US SAFER BECAUSE I ACTUALLY THINK IT MAY INCREASE RISKS IF OTHERS TRY TO REPLICATE EXPERIMENTS IN LESS SAFE MANNER, PERMUTATIONS TO GET IT RIGHT. AND OF COURSE IT DOESN'T MEAN SOME INFORMATION SHOULDN'T BE CLASSIFIED BUT THAT'S THE METHOD, CLASSIFICATION. I'LL GO BACK TO THE REAGAN MEMO 189, BEAUTIFULLY RIN, THE TO THE MAXIMUM EXTENT POSSIBLE PRODUCTS OF RESEARCH REMAIN UNRESTRICTED, SECURITY REQUIRES CONTROL, MECHANISM FOR CONTROL IS CLASSIFICATION. AND LASTLY I'LL JUST SAY FROM MY EXPERIENCE IT'S REALLY WHEN FACE THE WITH THESE DIFFICULT ISSUES, IT'S REALLY TEMPTING TO THINK ABOUT LIKE TO MODIFY TRIED AND TRUE WAYS TO ADDRESS -- WITH THE END IN MINE SO THE GOAL IS RESTRICT INFORMATION TO PREVENT IT FROM GOING INTO BAD ACTORS' HANDS, IT'S TEMPTING, THROUGH A PUBLIC HEALTH EMERGENCY MAYBE WE CAN WAIVE INFORMED CONSENT IN THE EMERGENCY, AND MODIFY TRIED AND TRUE WAY OF DOING THINGS, I THINK WE HAVE TO REALLY TAKE PAUSE AND THINK CAREFULLY ABOUT WHEN THIS HAPPENS AND REFLECT ON IT BECAUSE THE SHARING OF FUNDAMENTAL SCIENTIFIC INFORMATION IS REALLY FUNDAMENTAL TO OUR VALUES AS A SCIENTIFIC ENTERPRISE AND SOCIETY. IT'S WHAT MAKES US GREAT. AND WHAT HAS BEEN LINKED TO A LOT OF OUR SUCCESS, AND OUR SCIENTIFIC INNOVATION, AND HAS BEEN REAFFIRMED OVER AND OVER AGAIN. SO, AGAIN, I LEAVE ROOM FOR YOU TO DEBATE ON WHETHER, YOU KNOW, THERE IS ROOM FOR RESTRICTING BUT I THINK IT NEEDS TO BE DONE WITH EQUAL CARE AS YOU EVALUATE THE WISDOM OF THESE -- THE SCIENCE ITSELF. AND LASTLY I JUST WANT TO CLOSE BY SAYING THAT I WAS CONCERNED WHEN KEN MENTIONED THAT WHETHER THERE IS ANY IMPACT OF THIS GROUP TO THE ISSUES BECAUSE OF THE MORE -- THE SCOPE BEING FEDERALLY FUNDED RESEARCH, TINY PORTION, AND I WAS CONCERNED THAT ALL OF YOU WOULD PACK YOUR BAGS AND HAVE AN EXISTENTIAL MOMENT AND WHY ARE WE GOING TO SPEND THIS TIME HERE BUT I DO THINK EVEN IF THE AUTHORITY ITSELF IS LIMITED, I THINK THAT THE WORK THAT YOU DO SERVES VERY CRITICAL IMPORTANCE, A COMPASS, EXAMPLE OF FRAMEWORK AND GUIDING PRINCIPLES FOR HOW THE WHOLE WORLD MAY LOOK AT THIS RESEARCH, SO EVERYBODY'S WATCHING AND THE IMPACT IS MUCH GREATER THAN THE AUTHORITY THAT YOU HAVE TO RESTRICT OR NOT THE RESEARCH. THANK YOU. >> THANK YOU, EVERYONE. THAT WAS A LOT OF FOOD FOR THOUGHT. I'D LIKE TO DIVE IN A LITTLE BIT. I THINK WE HAD COMMENTS ON TRANSPARENCY OF PROCESS VERSUS SORT OF TRANSPARENCY OF PRODUCT FOR A LACK OF A BETTER WORD. AND I'D LIKE TO DIVE DOWN INTO THE -- WHERE THERE ARE GAPS TO BE FILLED, ONE WAY OR THE OTHER, ON BOTH OF THOSE SIDES BECAUSE I THINK THERE IS THIS QUESTION OF THE EXISTING REVIEW PROCESS ITSELF AND HOW MUCH TRANSPARENY THERE IS AROUND THE -- THE FDA EXAMPLE IS INTERESTING BECAUSE THERE'S A LOT OF TRANSPARENCY ABOUT THE PROCESS ITSELF, BUT NOT THE REVIEW UNTIL SORT OF AFTER THE FACTS, RIGHT? ONCE THE DECISION IS MADE, THEN EVERYTHING IS WIDE OPEN. SO MAYBE AN INTERESTING MODEL TO START A DISCUSSION FROM. BUT PROCESS IN TERMS OF CRITERIA, WHO ARE THE PEOPLE THAT IS VERY TRANSPARENT WHICH GETS AT SOME OF THE POINTS THAT WERE BEING MADE. AND DIFFERENTIATE THAT FROM -- I THINK PRODUCTS OF BOTH USE IN REVIEW, THAT YOU TALKED ABOUT, JESSICA, LABORATORY PLANS THAT MIGHT POSE SECURITY RISKS IF RELEASED, AS WELL AS THEN AT THE END OF THE REVIEW SO RESEARCH GOES FORWARD AND I THINK I GOT A SENSE THAT IT WOULD BE HELPFUL TO HAVE MORE DETAILS OF THE RESEARCH ITSELF BEYOND SORT OF WHAT THE CURRENT LEVEL OF TRANSPARENCY IS AND THERE'S SORT OF NIH TRANSPARENCY MEASURES, WE PUT OUR FUNDED RESEARCH OUT THERE BUT MAYBE NOT TO THE LEVEL OF DETAIL WE'RE TALKING ABOUT. COULD WE DIVE DOWN WHAT ARE THE PIECES OF THE PROCESS VERSUS SORT OF THE PRODUCTS THAT IT WOULD BE MOST HELPFUL TO HAVE MORE TRANSPARENCY ON OR WHETHER THERE ARE CONCERNS ABOUT TRANSPARENCY RAISED?? I DON'T KNOW IF ANYONE WANTS TO VOLUNTEER TO GO FIRST. >> I'LL GO. WHEN I WAS GOING BACK BRIEFLY, REVIEWING THE FRAMEWORK THAT WAS DISCUSSED EARLIER THIS MORNING, I WAS SURPRISED THAT THE SCOPE OF WHAT'S CAPTURED IN THE RISK MITIGATION PLANS WASN'T AS CAPTURED IN THAT DOCUMENT AS I WAS EXPECTING IT TO. AND I THINK A LOT OF THE CONCERNS THAT HAVE BEEN RAISED BY MEMBERS OF THIS PANEL ARE ADDRESSED IN AT LEAST SOME CAPACITY, A LOT OF PLANS IN TERMS OF MONITORING FOR DUAL USE POTENTIAL, RESPONSIBLE COMMUNICATION, REVIEW OF DOCUMENTS BEFORE THEY WOULD BE PUT OUT TO JOURNALS, APPLICABILITY OF COUNTERMEASURES, USE OF ATTENUATED STRAINS, BY PUTTING MORE INFORMATION IN PUBLICLY AVAILABLE DOCUMENTS ABOUT SCOPE OF THINGS BEING CAPTURED DURING THIS REVIEW THAT MIGHT HELP ASSURE OTHERS ABOUT THE FULL SCOPE THAT IS GOING ON TO MAKE SURE THIS WORK IS GOING ON SAFELY AND SECURELY. >> MAY I JUST MAKE A POINT ABOUT WHETHER OR NOT THE JOURNALS HAVE A REVIEW PROCESS? SO ASM JOURNALS, I'M THE EDITOR IN CHIEF OF JOURNAL OF VIROLOGY, ON EVERY REVIEWERS' FORMS HAVE DURC CONDITIONS AND YOU HAVE TO CHECK I DO NOT ANY -- TO CHECK WHETHER OR NOT THEY HAVE BEEN MET. I HAVE TO REVIEW EVERY SINGLE PPP, WHATEVER IT IS, AND DECIDE WHETHER OR NOT IT MEETS CRITERIA, IF I DON'T HAVE A COMPLETE UNDERSTANDING WE HAVE WHAT'S CALLED THE ASM RESPONSIBLE PUBLICATION COMMITTEE, WHICH IS COMPRISED OF SEVERAL EDITORS AND CHIEFS, TWO OF WHOM WERE FORMER MEMBERS OF THE NSABB. AND THEREFORE WE'RE VERY, VERY CAREFUL ABOUT WHAT WE PUBLISH. I'LL ALSO POINT OUT THAT IN THE PAST TEN YEARS, RATHER THAN HAVING THE MAJORITY OF SUBMISSIONS TO THE JOURNAL BE FROM U.S. LABORATORIES, 60% OF OUR SUBMISSIONS NOW ARE FROM INTERNATIONAL LABORATORIES. AND ONLY 40% ARE FROM THE U.S. AND WHEN A GROUP IN CHINA SAYS THAT THEY HAVE MET THE CONDITIONS OF THE CHINESE INSTITUTIONAL BIOSAFETY REVIEW, WE HAVE NO IDEA WHAT THAT BIOSAFETY REVIEW IS. >> RESPONSES TO THAT OR THE QUESTION OF TRANSPARENCY IN PRODUCT? >> THANK YOU FOR THAT. THAT'S HELPFUL TO KNOW. I HOPE THERE'S MORE OUT THERE TOO. BUT THERE'S SOME JOURNALS THAT ARE NOT THAT ADVANCED. IN TERMS OF THE TRANSPARENCY OF PRODUCT, THERE MIGHT BE MORE SUPPORT AT THE MOMENT FOR TRANSPARENCY OF PROCESS THAN PRODUCT, PROGRAMS. IN THE ARTICLE TOM AND I WROTE YESTERDAY WE CALL FOR SOMETHING ONE STEP MORE THAN IS THERE NOW, AND THERE'S BEEN SOME COMMENT THAT IT WOULD BE INFEASIBLE OR NOT LEGAL TO DISCLOSE FUNDING DECISIONS. I GUESS THE WAY THAT WE'VE BEEN THINKING ABOUT IT IS THAT FIRST OF ALL AGAIN THIS IS FOR A LIMITED SCOPE, ORDINARY ANY REVIEW, THE QUESTION THAT A MEMBER OF THE PUBLIC MIGHT HAVE, HAVE TAXPAYERS' MONIES BEEN WELL SPENT ON PROMISING RESEARCH AS OPPOSED TO LESS PROMISING RESEARCH. AND THAT'S AN IMPORTANT QUESTION, BUT IT'S A COMPLETELY DIFFERENT KIND OF QUESTION FROM HAS MY COMMUNITY IN OKLAHOMA BEEN PUT AT RISK BY SOME EXPERIMENT IN MINNESOTA, WHICH IS COMPLETELY A RISK OF LIFE AND INFECTION. AND TO ME, THOSE KINDS OF QUESTIONS MERIT A HIGHER LEVEL OF TRANSPARENCY THAN ORDINARY QUESTIONS OF SCIENTIFIC DECISION-MAKING. SO THAT'S -- AND SO THE -- ANOTHER ANALOGY MIGHT BE ENVIRONMENTAL IMPACT STATEMENT, SO WHEN SOMETHING -- WHEN A PROJECT OF A GOVERNMENT, FEDERAL OR OTHERWISE, PUTS PEOPLE AT RISK OR ENVIRONMENT AT RISK THROUGH POLLUTION OR OTHER MEANS THERE'S A VERY LONG -- VERY LONG OFTEN PRE-PROJECT, PRE-FUNDING DISCUSSION THAT'S VERY PUBLIC WITH THE PEOPLE BEING IDENTIFIED AND THEIR PREMISES AND CLAIMS BEING IDENTIFIED, IN OPEN MEETINGS. AND THE OTHER ASPECT WOULD BE SOMETHING LIKE DRUG APPROVAL WHERE IF A DRUG IS APPROVED, BASIS, ACTUAL BASIS ON WHICH IT'S APPROVED HAS TO BE MADE PUBLIC. IF WE EXPAND BEYOND PEER REVIEW, NOT WHAT WE'RE TALKING ABOUT, WE'RE TALKING ABOUT A DECISION ABOUT PUBLIC HEALTH AND SAFETY, AFTER PEER REVIEW, BUT BEFORE FUNDING, I THINK THE OPTIONS MAY BE GREATERs. I'M NOT A LAWYER. MAYBE THE LAW NEEDS TO BE CHANGED, I HAVE NO IDEA WHAT'S LEGALLY POSSIBLE BUT IN TERMS OF GOOD POLICY A GREATER DEGREE OF TRANSPARENCY OF PRODUCT IS JUSTIFIED. >> OTHER THOUGHTS? >> I WANT TO COMMENT ON THE PAPERS, TRANSPARENCY. WHEN REVIEWING A PAPER, YOU WANT TO KNOW WHAT THE RELEASE, THE HN 1 WAS BOTCHED BECAUSE YOU DIDN'T REPORT IMPORTANT INFORMATION BUT DID ONE LATER ON, ANTHRAX TOXIN PAPER WHERE SOMEONE FOUND NO VARIETIES OF ANTHRAX TOXINS, AND THAT WAS NOT GOOD BECAUSE WE DIDN'T HAVE ANTIBODIES TO TREAT PEOPLE. >> BOTULINUM. >> AND THEN THE IDEA WAS ONCE THE ANTIBODIES ARE MADE, YOU COULD THEN RELEASE THE SEQUENCE. THAT'S A GOOD WAY TO DO IT BECAUSE PEOPLE KNOW EXACTLY WHAT WAS DONE. THEY DON'T NEED TO SEE THE FINAL PRODUCT. SAME WAY H5 PAPER COULD HAVE BEEN RELEASED. YOU DON'T KNOW HOW SCARED THE PUBLIC ARE. THEY SEE YOU AS AN IMPENETRABLE VEIL. THEY GET STATEMENTS FROM THE PRESS NOT ALWAYS GOOD. YOU HAVE TO PROVIDE INFORMATION ABOUT WHAT'S IN THE PAPER TO THE EXTENT IT DOESN'T VIOLATE SAFETY, I AGREE RELEASING THE TOXIN SEQUENCE WOULD BE A PROBLEM. I THINK CAN YOU DO THAT READILY. IT TAKES MORE WORK ON YOUR PART. >> I WAS GOING TO SAY THAT I DO THINK IT IS -- THERE ARE PLACES WHERE WE COULD IMPROVE TRANSPARENCY IN THE PROCESS, AS WELL AS CONTENT. WHAT JESSICA SAID ABOUT RISK MITIGATION MEASURES EVALUATED BY THE COMMITTEE I PRESUME KNOWING, ANALYSIS WOULD BE USEFUL, THE TERM USED IN THE OVERALL P3CO FRAMEWORK IS WE NEED TO DEVELOP A PLAN FOR, QUOTE, RESPONSIBLE COMMUNICATION. AND I DON'T KNOW WHAT THAT IS. WE'VE BEEN TALKING ABOUT THESE THINGS FOR A LONG TIME. IT'S IN THERE AS IF IT'S KIND OF A LOGICAL NEXT STEP, IF YOU GET TO STEP 3, LET'S DEVELOP A PLAN FOR RESPONSIBLE COMMUNICATION. WE GET DIRECTLY TO THE ISSUES THAT VINCE AND LU ARE TALKING ABOUT, TRANSPARENCY OF SCIENCE TO THE PUBLIC, I'M AGAINST FOR EXAMPLE CLASSIFICATION OF THIS RESEARCH. I THINK IT WOULD CONVEY TO THE WORLD WE'RE DOING SOMETHING SECRET, THAT'S BAD, AND THEY MAYBE SHOULD CLASSIFY THEIR OWN RESEARCH IN WHATEVER COUNTRY AND THEY SHOULD START A PROGRAM OF THEIR OWN. I THINK CLASSIFICATION IS BAD. I THINK CENSORING OR NOT ALLOWING PUBLICATION IS THE WRONG PLACE IN THE PROCESS TO BE REALLY TRYING TO THINK THROUGH OVERSIGHT AND CONTROL. BUT I THINK AS A LAST STEP IF THE REST OF THE SYSTEM HAS NOT WORKED, AND WE FIND OURSELVES SUDDENLY AT THE POINT OF, WELL, THIS WORK HAS BEEN DONE, I THINK WE GET TO A DIFFICULT SET OF DECISIONS AND THEN I THINK WE HAVE THIS DISCUSSION ABOUT RESPONSIBLE COMMUNICATION. AND DESPITE TEN YEARS OF DISCUSSION WITHIN THE NSABB AND ELSEWHERE ABOUT WHAT RESPONSIBLE COMMUNICATION WOULD LOOK LIKE WE DON'T HAVE THAT. MARK AND I AND OTHERS ALSO AGREE WITH WHAT LU SAID ABOUT THE IMPORTANCE OF PUBLISHING FUNDAMENTAL SCIENCE BUT IN THIS CASE FUNDAMENTAL SCIENCE COULD MEAN WE'RE SHOWING YOU ONE SPECIFIC STEP THAT CHANGES AN ORGANISMS POTENTIAL TO SPREAD WIDELY, THAT'S BOTH FUNDAMENTAL AND POSSIBLY IMMEDIATELY APPLIED BY SOPHISTICATED LABORATORIES, AN AREA OF WORK WHICH ISN'T WELL DEFINED IN THE FOUNDATIONAL BASIC SCIENCE CATEGORY OR APPLIED SCIENCE CATEGORY. SO I THINK THE PROBLEM IS THAT WE MIGHT BE THINKING THAT THERE IS JUST SOME CATEGORY OF SIMPLE PRACTICAL RESPONSIBLE COMMUNICATION BUT I DON'T THINK THATTIST EXAMINES. BASICALLY IT'S EITHER IT ISN'T DONE OR APPROVED BECAUSE WE THINK IT'S NOT THE RIGHT THING TO DO LIKE WE SET LIMITS ON OTHER AREAS OF RESEARCH AROUND RADIATION SAFETY, AROUND HUMAN CLINICAL TRIALS, OTHER THINGS, EITHER WE DECIDE SOMETHING SHOULDN'T BE DONE IN THE FIRST PLACE OR MOST LIKELY IT'S GOING TO BE PUBLISHED. THERE ISN'T ANY WAY PRACTICALLY TO STOP THAT. THAT SHOULD BE OUR FRAMEWORK UNLESS THERE'S ANOTHER PATHWAY FOR, QUOTE, RESPONSIBLE COMMUNICATION. >> I WILL SAY THAT I THINK, I'D BE INTERESTED IN -- SOME FOLKS AROUND THE TABLE SAT THROUGH THIS. I MEAN, THE NSABB OVER THE PAST 16 YEARS, I WOULD SAY, HAS DONE A LOT ON RESPONSIBLE COMMUNICATION AND PUT A LOT OF ACTUALLY GUIDANCE IN PLACE. I AGREE WITH YOU THAT IT'S NOT SIMPLE. IT REQUIRES A LOT OF HUMAN JUDGMENT. I MEAN, IT IS GUIDANCE. INTERESTED IN HEARING FROM NSABB MEMBERS AS WELL AS FOLKS ON THE PANEL, PRACTICALLY SPEAKING PEOPLE DO USE THAT GUIDANCE AND IT DOES IMPACT, YOU KNOW, SOUNDS LIKE IT'S HAVING AN IMPACT AT THE JOURNAL LEVEL CERTAINLY, SO IT DOES FEELIC HAS BEEN OPERATIONALIZED. >> REACTION TO THAT, SO I DO THINK THERE HAS BEEN A LOT DONE ABOUT RESPONSIBLE COMMUNICATION, IF YOU READ WHAT IS BEING SAID OFTEN IN THE NSABB DELIBERATIONS EARLIER, RESPONSIBLE COMMUNICATION THERE IS MAKE SURE THAT THE SCIENTISTS DOING THE WORK DESCRIBE IT IN A WAY THAT DOESN'T ALARM THE PUBLIC. WHICH IS A VERY DIFFERENT PURPOSE OF RESPONSIBLE COMMUNICATION. IT DOESN'T INCLUDE WHAT WE MIGHT THINK AS A PATHWAY WHICH REDUCES SAFETY AND SECURITY CONCERNS. IT'S MORE ABOUT GUIDANCE TO SCIENTISTS TO BE GOOD COMMUNICATORS ABOUT THEIR WORK AND NOT ALARMING ABOUT THEIR WORK. A LOT IN THAT CATEGORY IS USEFUL, ALSO SEEN IN THE WORST CASE AS SPIN. I DON'T THINK ANYONE DOES SPIN BUT BASICALLY THAT'S NOT WHAT WE'RE TALKING ABOUT HERE AS RESPONSIBLE COMMUNICATION. >> ONE MORE QUESTION FOR THE PANEL AND I'LL OPEN TO THE NSABB MEMBERS TO HAVE THE REST OF THE SESSION TO DISCUSS. WHICH IS THIS DRILLDOWN ON THIS TIMING QUESTION A LITTLE BIT BECAUSE WE ARE IN THIS SPACE OF POST-PEER REVIEW, PRE-FUNDING, NORMALLY A SPACE AS YOU ALL KNOW FOR VERY GOOD REASONS PROTECTED BY A LOT OF RULES OF CONFIDENTIALITY AND I THINK IT'S PROBABLY ALSO IMPORTANT TO NOTE THAT WHILE DECISIONS RELATED TO PEER REVIEW ARE TRANSPARENT IN THE SENSE THINGS THAT ARE FUNDED ARE TRANSPARENT, ARE PUBLICLY AVAILABLE, THE REVIEW ITSELF ACTUALLY REGARDLESS, SUCCESSFUL OR NOT, IS NOT TRANSPARENT AND THERE ARE LEGAL REASONS AND I THINK A LOT OF OTHER REASONS FOR THAT. SO I'D BE INTERESTED IN THE THOUGHTS OF THE PANEL ABOUT WHERE THIS DISCUSSION OF NEED FOR MORE TRANSPARENCY AROUND REVIEW PROCESS FITS INTO THAT SORT OF CULTURE AND PRACTICE AND RESTRICTIONS AROUND PRE-FUNDING DECISIONS BECAUSE THERE'S SOME PRACTICAL ISSUES TO THINK THROUGH THERE. >> A QUICK COMMENT. I THINK I'M IN FAVOR OF HAVING THAT REVIEW PROCESS BE DONE BEFORE FUNDING BECAUSE I THINK IF IT HAPPENS AFTER FUNDING AND THE WORK IS DONE WE'VE SHIFTED THE DISCUSSION POINT TO SHOULD WE PUBLISH THE WORK. I THINK WE ALL AGREE WHEN THE WORK IS DONE, THERE ARE VERY FEW PRACTICAL WAYS OR GOOD WAYS TO TRY AND PREVENT PUBLICATION. WE'VE SEEN HOW MANY PROBLEMS THERE ARE WHEN THAT HAPPENS. SO IT SEEMS THAT IF THERE IS GOING TO BE ANY INPUT OUTSIDE THE REVIEW PROCESS FROM OUTSIDE, FROM THE SCIENTIFIC COMMUNITY OR PUBLIC HEALTH COMMUNITY OR OTHERS, IT SEEMS LIKE IT SHOULD BE GIVEN BEFORE THE WORK IS STARTED TO BE FAIR TO THE SCIENTISTS WHO ARE INVOLVED BECAUSE OTHERWISE ONCE THAT PROCESS STARTS THEN ARE WE TRYING TO CENSOR THE WORK THEY DID? EVEN IF IT IS UNUSUAL AS COMPARED TO NORMAL NIH PROCESS. >> YEAH, I THINK I GUESS IT COMES BACK TO THE POINT I MADE BEFORE. I THINK THE CONSIDERATIONS THAT I'M AWARE OF FOR WHY WE KEEP THE SUBSTANCE OF THE PEER REVIEW CONFIDENTIAL ARE CONSIDERATIONS LIKE CAREER INTERESTS OF THE SCIENTISTS INVOLVED, POSSIBILITY THAT THEY COULD HAVE THEIR INTELLECTUAL PROPERTY STOLEN, NOT STOLEN BUT TAKEN. CONSIDERATIONS LIKE THAT. THEY ARE NOT CONSIDERATIONS -- THOSE ARE CONSIDERATIONS THAT ARE VERY IMPORTANT AND THAT FOR THE WHOLE SEEK OH SIS -- ECOSYSTEM OF SCIENCE WE HAVE TO KEEP GOING. YOU CAN'T STUDY NUCLEAR BOMBS IN ANY OLD PLACE. IF YOU WANT TO DO SCIENCE OF NUCLEAR BOMBS YOU CAN DO IT UNDER CERTAIN CONDITIONS WHICH LEAVE LESS AUTONOMY. THERE ARE OTHER KINDS OF SCIENCE THAT MOST -- VAST MAJORITY OF SCIENCE, THOSE CONSIDERATIONS OF SCIENTIST CAREERS AND TRADE SECRETS ARE IMPORTANT BUT IT'S REASONABLE TO SAY THERE'S A SMALL CATEGORY OF SCIENCE, IF YOU WANT TO DO THE SCIENCE YOU SACRIFICE SOMETHING. YOU CAN EITHER CHOOSE TO DO OUT -- DO IT OR NOT BUT IF YOU DO IT'S GOING TO BE SUBJECT TO THE PEOPLE 8,000 MILES AWAY WHO MIGHT BE AFFECTED BY IT BECAUSE OF RISK OF ACCIDENT, THAT SEEMS REASONABLE EVEN IF IT WOULD BE A CATASTROPHE, IF WE DID THAT, WELL, UNFORTUNATE IF WE DID THAT FOR SCIENCE IN GENERAL. >> I'LL ADD THAT HAVING A MORE TRANSPARENT -- THE INFORMATION AVAILABLE ALSO ELEVATES THE RIGOR AND INTEGRITY OF THE REVIEWER'S WORK BECAUSE THEIR OPINION OR ASSESSMENT OF THE WORK IS ALSO PUBLICLY AVAILABLE. I THINK THAT'S IMPORTANT. >> LET ME OPEN TO THE NSABB. OH, ONE MORE. >> WE SHOULD THINK ABOUT WHETHER THE PUBLIC CARES ABOUT TRANSPARENCY AT THIS STAGE. I THINK WHEN THE WORK IS DONE THEY WANT TO SEE IT AND KNOW THE IMPACT FOR THEIR LIVES. SO THE PROCESS OF DELIBERATION IN THE H5N1, I WAS OKAY BUT I DON'T KNOW WHAT PEOPLE THINK. IF THEY DON'T CARE, I DON'T KNOW HOW YOU GET THAT INFORMATION, BUT THAT'S IMPORTANT. MY COLLEAGUES HERE THEY WANT TO SEE MORE TRANSPARENCY, I UNDERSTAND THAT, BUT WE'RE NOT GOING TO DO IT FOR TWO PEOPLE, WE'RE GOING TO DO IT FOR THE PUBLIC. I'M JUST NOT CONVINCED FROM WHAT I I HEAR THEY WANT TO KNOW AT THAT STAGE WHAT YOUR DELIBERATIONS ARE TO MAKE THIS WORK GO FORWARD. THAT'S SOMETHING YOU NEED TO FIND OUT SOMEHOW. >> AND JUST TO FOLLOW UP WITH THAT AT THE END, I DO TAKE -- I THINK THE USE OF TRADE SECRETS COULD BE MISCONSTRUED. WHEN YOU HAVE RISK MITIGATION ANALYSES OF COURSE SCIENTIFIC MERIT OF PROPOSAL IS LARGE COMPONENT BUT THE FACILITIES DESIGNED AND BIOCONTAINMENT INFORMATION MAY BE FOUND TO BE WARRANTING IMPROVEMENT WHICH DURING THIS REVIEW PROCESS COULD LEAD TO A SAFER AND GREATER WAY FOR SCIENTISTS TO DO THIS WORK IN GENERAL AND SO I THINK BY JUST SAYING THAT WE'RE TRYING TO KEEP INFORMATION LESS TRANSPARENT DURING THIS PARTICULAR PROCESS IS NOT SOLELY DUE TO SCIENTIST CAREERS. THERE'S MORE TO IT THAN JUST THAT. >> ALL RIGHT. WE'VE HAD THE FULL SUITE. LET'S OPEN UP TO NSABB. MARK, YOU HAD YOUR HAND UP. >> YEAH. THANK YOU ALL. I'M SORRY I DON'T WANT TO STAND BECAUSE OF THE MIC AND I'M NOT TALL ENOUGH TO SEE YOU ALL. I GUESS AGGREGATELY, IN SOME CASES, I HEARD SOME THINGS WHICH FELT LIKE A LITTLE BIT OF ALTERNATIVE UNIVERSE TO WHAT I LIVE IN. I DON'T MEAN THAT IN A NEGATIVE WAY. WHAT I MEAN IS THERE'S THINGS THAT DON'T RESONATE WITH HOW WE DESIGN AND IMPLEMENT OUR WORK. WE'RE NOT -- I'D LIKE TO ASK ABOUT THE BOUNDARIES ON THIS, BUT A COUPLE ISSUES AROSE AND I'D LIKE TO THE PANEL TO CONSIDER THESE. ONE IS ISSUE OF TRANSMISSION OF INFORMATION THAT WE'RE REQUIRED TO SEND INFORMATION. WORKING WITH SELECT AGENTS, DSL-3, THERE'S NOTHING I'M GETTING REQUESTED THAT ISN'T UNDER REGULATION, EXPORT CONTROL IS A MORE SERIOUS HAMMER ON MY BACK RIGHT NOW THAN ANYTHING ELSE THAT I DO. PENALTIES ARE PROFOUND. WE HAVE TO DO DUE DILIGENCE THROUGH MULTIPLE LEVELS, MAYBE THROUGH SELECT AGENT PROGRAM, MIGHT BE THROUGH EXPORT CONTROL, MIGHT BE THROUGH OTHER CATEGORIES AS WELL, GENERAL CONCERN WE DON'T KNOW THIS PERSON, NEVER HEARD OF THEM SO WE'RE NOT SENDING THEM EITHER INFORMATION OR MATERIALS UNTIL WE VALIDATED THAT. SO THAT'S -- THAT DOESN'T RING TRUE TO ME AS THAT KIND OF CONCERN BUT MAYBE THE UNIVERSE I LIVE IN IS A TINY BUBBLE AND SO I'D LIKE TO HEAR MORE. ANOTHER ONE IS THIS ISSUE OF LOTS OF ACCIDENTS. LOTS OF ACCIDENTS THAT GO UNREPORTED. EVERY SINGLE LAB I WORK WITH IS UNDER SUCH STRICT REGULATION AND CONTROL THAT A SPILL OR A DROPOUT SIDE OF A BIOSAFETY HOOD FOR SELECT AGENT HOOD IS REPORTABLE FOR BSL3 IT MIGHT BE REPORTABLE TO THE NIH. SOME THINGS ARE GUIDELINE BUT ARE POWER OF LAW, OTHER THINGS ARE LAW WITH POWER OF CRIMINAL PUNISHMENT. CRIMINAL PENALTIES. SO WE'RE UNDER ABSOLUTE GUIDELINES THAT SAY IF YOU HAVE ANY CONCERNS, IF YOU DROP SOMETHING, SPILL SOMETHING, A TEAR, ANYTHING, THAT'S A PROCESS THAT'S REPORTABLE PROCESS. SO THIS CONCEPT THAT PEOPLE AREN'T REPORTING THIS STUFF FEELS TO ME WITH THESE PARTICULAR PATHOGENS THAT WE'RE TALKING ABOUT, FEELS TO ME NOT TO RING REALLY TRUE AS WELL. THOSE ARE -- THOSE ARE TWO THINGS, I'D LIKE TO HAVE ADDRESSED IF THEY ARE REAL, IF THEY ARE REAL THINGS THAT HAVE BEEN DOCUMENTED THAT HAVE DATA ASSOCIATED WITH THEM, IF ANYBODY WANTS TO COMMENT ABOUT THAT. OR NOT. >> [OFF MICROPHONE]. >> YEAH, QUICK COMMENT ABOUT BOTH OF THOSE. IN TERMS OF SELECT AGENT PROGRAM, I THINK THE DISTINCTION WE'RE TALKING ABOUT HERE IS NOT THAT PEOPLE HAVEN'T GONE THROUGH REGULATION AND HAVE PERSONNEL OR LIABILITY AND COMPLY WITH CDC OR USDA, WHICH I'M SURE THEY HAVE, I KNOW IT'S QUITE REGULATED, I THINK SELECT AGENT PROGRAM ACTUALLY IS A BIT OVER THE TOP IN SOME WAYS, NOT BECAUSE OF CDC CHOICES BUT THE WAY IT WAS CONSTRUCTED BUT IN ANY EVENT THAT'S CERTAINLY A RIGOROUS PROGRAM. WE'RE TALKING ABOUT HERE DISCLOSURE AND REVIEW OF THE PARTICULAR WORK THAT IS GOING ON AROUND POTENTIAL PATHOGENS TO ENHANCE THEM. TO MY UNDERSTANDING CDC AND U.S.DA AND GOVERNMENT AUTHORITIES DON'T HAVE A PARTICULAR WAY OF REVIEWING THOSE EXPERIMENTS OUTSIDE OF THE SELECT AGENT RULES USED FOR ALL SELECT AGENTS. THEY DON'T STAND OUT AS PARTICULARLY WORRISOME OR SHOULD BE HANDLED DIFFERENTLY. EXPERIMENTS HERE AGAIN THIS IS A VERY, VERY SMALL SUBSET OF POTENTIAL PANDEMIC PATHOGENS. THOSE EXPERIMENTS WERE NOT DISCLOSED TO THE PUBLIC. REVIEW PROCESS WAS NOT DISCLOSED TO THE PUBLIC. WE'RE NOT TALKING ABOUT IT BEING OUTSIDE OF ANY REGULATION. THERE IS REGULATION. BUT THAT GETS TO THE SECOND POINT WHICH IS EVEN IN SOME COUNTRIES' BEST LABORATORIES THERE ARE ACCIDENTS. IN THE LAST FIVE YEARS THERE HAVE BEEN TWO ACCIDENTS AT CDC, ONE WITH ANTHRAX AT DoD, VERY HIGH PROFILE. IT'S ALSO THE CASE A FEW PEOPLE SAID IT, PAPERS WRITTEN, WE DO NOT HAVE GOOD COLLECTION OF DATA AROUND -- OR GOOD ENOUGH COLLECTION AROUND BIOSAFETY. THE PEOPLE WHO RUN LABS AROUND THIS TABLE FOR THE MOST PART ARE EXTRAORDINARILY SAFE, BUT IF WE SHOULD DO RISK ASSESSMENT, WE SHOULD DO QUANTITATIVE EVALUATION OF THAT. WE HAVE -- MARK AND I PREVIOUSLY HAVE WRITTEN ON THAT AND WE COULD REVIEW THE HIGHLIGHTS IF YOU LIKE. OTHER PEOPLE HAVE WRITTEN ABOUT BIOSAFETY IN THE COUNTRY AND RECORD WE HAVE. IT'S A VERY GOOD RECORD BUT IT'S NOT PERFECT. YOU CAN MAKE A QUANTITATIVE RISK ASSESSMENT ABOUT HOW OFTEN ACCIDENTS HAPPEN IN THE UNITED STATES. >> THIS IS OUR OPPORTUNITY TO TALK ABOUT THIS. WE HAVE PROBABLY, YOU KNOW, WE DON'T GENERATE HUGE AMOUNTS OF MONEY FOR THIS PROGRAM, MAYBE A MILLION DOLLARS, NOT EVEN THAT MUCH A YEAR, RIGHT? >> NSABB? >> NO, MY RESEARCH PROGRAM, REQUIRES 50% OF A BORIO SAFETY OFFICER, RESPONSIBLE OFFICIAL, MULTIPLE PEOPLE THAT SPEND TREMENDOUS AMOUNTS OF TIME OVER EVERYTHING. WE'RE NOT UNIQUE, SCHEDULES GET REVIEWED IN DETAIL OR ON SELECT AGENT RULES. WHERE IS THAT GETTING MISSED, RIGHT? I DON'T UNDERSTAND WHERE THESE ACCIDENTS OCCUR, I AGREE, NON-REPORTING AND MISREPORT OF OF IT I DON'T AGREE, AT LEAST BASED ON MY UNDERSTANDING HOW PEOPLE FUNCTION UNDER THESE RULES AND REGULATIONS. SO THAT'S WHAT I DON'T UNDERSTAND. >> I WAS LOOKING FOR THE REFERENCE AND CAN'T FIND IT. THERE WAS AN ARTICLE BY ONE OF THE DUTCH BIOSAFETY REGULATORS REVIEWING THE GLOBAL SITUATION, AND THEIR ESTIMATE WAS THAT LESS -- I BELIEVE LESS THAN HALF OF ACCIDENTS GET REPORTED. AND IT WAS NOT ONLY APPLICABLE TO THE NETHERLANDS BUT THAT WAS ONE OF THEM. BUT I THINK YOU'RE RIGHT THAT HIGH CONSEQUENCE ACCIDENTS OFTEN DO GET REPORTED, AND THAT GETS TO A QUESTION YOU RAISED EARLIER. I THINK -- WHICH IS ARE WE ASSUMING DISASTER SCENARIOS ARE CERTAIN TO HAPPEN. I WANT TO EMPHASIZE IN RISK ASSESSMENT TOM AND I PUBLISHED WE THOUGHT THE RISK WAS AROUND -- WAS GREATER THAN 1 IN 1,000 TO 1 IN 10,000 PER LABORATORY YEAR IN A BSL3. THAT MEANS THAT THAT'S BASED ON NUMERATORS WHICH ARE INCOMPLETE AND DENOMINATORS ALSO INCOMPLETE, LESS SO IN THE UNITED STATES. AMONG OTHER THINGS, FIRST OF ALL YOU DON'T NEED A VERY LARGE NUMERATOR TO START MAKING THOSE ESTIMATES. IT TELLS YOU YOU DON'T -- YOU HAVE UNCERTAINTY BUT DOESN'T MEAN HAVE YOU NO INFORMATION, EVEN A FEW ACCIDENTS ARE INDICATIVE OF A RATE. IF YOU KNOW ANYTHING ABOUT THE DENOMINATOR, AND THE SECOND POINT IS OF COURSE ONE IN IS THOUSAND PER YEAR MEANS THAT THE VAST MAJORITY OF PROBABILITY IS ON NOTHING'S GOING TO HAPPEN, NOTHING OF HIGH SEQUENCE IS GOING TO HAPPEN. AND EVERYONE SENSIBLE ADMITS THAT IN A WELL-RUN LAB. THE PROBLEM IS WHEN YOU MULTIPLY BY THE CONSEQUENCE, 1 IN 1,000 OR 1 IN 10,000 CHANCE OF INFECTING THOUSANDS OR MILLIONS OF PEOPLE IS A REALLY BAD THING, WHICH NO HUMAN ETHICS BOARD WOULD EVER SAY WAS ACCEPTABLE. THIS IS NOT REGULATED BY HUMAN ETHICS BOARDS. >> OTHER QUESTIONS? STEPHEN? >> THANK YOU. YEAH, I'M IMPRESSED BY THE SPIRITED DISCUSSION. I THINK IT'S GOOD TO HAVE THE SPIRITED DISCUSSION ABOUT THIS SUBJECT. I JUST WANTED TO ADD TO SOME OF THE COMMENTS THAT MY COLLEAGUE, DR. SANDRI-GOLDIN MADE ABOUT PUBLICATIONS, THANK YOU FOR THINKING ABOUT PUBLICATIONS AND THE ISSUE OF THE PUBLISHERS, ACTUALLY THIS QUESTION HAS COME UP BEFORE. BACK IN 2003, THERE WERE SEVERAL PUBLICATIONS OF ACTUAL CONCERN, INTRODUCTION OF THE INTERLEUKIN 4 GENE INTO MOUSEPOX FOR EXAMPLE AND SEVERAL OTHERS, SOME MODIFICATIONS WITH ANTHRAX, THERE WAS A MEETING GETTING TOGETHER EDITORS AND AUTHORS AND OTHERS, RON ATLAS GOT TO BE THE FIRST AUTHOR BECAUSE HIS NAME STARTED WITH A, HAROLD VARMUS WAS NEAR THE END. PUBLISHERS WORKED OUT A PROCEDURE, ASM, TOM SHANK I THINK REPRESENTED THEN EDITOR OF THE JOURNAL OF VIROLOGY REPRESENTED ASM AT THE TIME, YOU KNOW, ACTUALLY WORKED OUT A PROCEDURE WHICH ASM HAS AMPLIFIED I THINK AND REGULARIZED TO FORMALIZE TO A PARTICULAR DEGREE BUT THAT PROCEDURE WAS IN PLACE, AND THE CONCERNS WERE THAT IT WAS THE -- JOURNALS WERE BECOMING THE LAST LINE OF DEFENSE RATHER THAN FIRST LINE OF DEFENSE AND THAT PEOPLE COULD ALWAYS GO TO LESS PRESTIGIOUS JOURNALS SINCE THESE WERE MOSTLY THE MOST IMPORTANT JOURNALS THAT WERE REPRESENTED THERE. SO I THINK IT REMAINS A QUESTION, I THINK YOUR SUGGESTION IS VERY INTERESTING ONE, FOR PERHAPS HAVING THOSE THAT ARE PRE-REVIEWED IN THE PROCESS THAT DIDN'T EXIST BACK IN 2003, THEN BE ABLE TO SEND ALONG JUST AS WE TALKED ABOUT IRB CERTIFICATION OR SOMETHING LIKE THAT TO SEND ALONG ANOTHER CERTIFICATION, THAT THIS WORK WAS APPROVED, AND THINK THAT MIGHT MAKE IT MORE FEASIBLE. THE ISSUE AS DR. SANDRI-GOLDIN BRINGS UP, HOW DO YOU DEAL WITH THE FOREIGN PUBLICATIONS, AT LEAST THOSE WHO SEND MANUSCRIPTS FROM OTHER COUNTRIES TO SOME DEGREE ARE SUBMITTING TO SECURITY RESTRICTIONS AND SECURITY REVIEWS THAT WE HAVE WITH OUR JOURNALS OR SOME OF OUR JOURNALS BUT THERE ARE MANY OF COURSE WHO ARE ABLE TO PUBLISH IN OTHER JOURNALS, AND ARE BEYOND OUR REACH. I JUST WANT TO BRING UP THAT BIT OF HISTORY BECAUSE I THINK IT'S INTERESTING TO SEE NOW THAT WE MAY BE IN A BETTER POSITION WITH A MORE COMPREHENSIVE SYSTEM, YOU KNOW, TO ENFORCE OR IMPLEMENT A SYSTEM. >> QUICK REACTIONS FROM PACKAGE MEMBERS AND THE NEXT ONE? >> I WAS GOING TO POINT OUT TO PEOPLE, YOU MAY BE AWARE ALREADY OF THE NATIONAL ACADEMY'S REPORT. STEVE, YOU MAY HAVE BEEN PART OF THIS, 2 1/2 OR 2 YEARS AGO, WHICH WAS A QUICK STUDY BUT INCLUDED DR. VARMUS, DR. FINK, ARTURO CASA DUVALL, IT SAID JOURNAL EDITORS DO NOT HAVE A PROCESS FOR CONSULTING SOME HIGHER LEVEL AUTHORITY WHEN ISSUES LIKE THIS COME UP. I THINK THIS POINT WAS MADE JUST NOW, AND KEN COULD TALK ABOUT THIS BUT I THINK NSABB ORIGINALLY WAS INTENDED TO SERVE SOMETHING LIKE THAT ROLE. IT IS NOW SHIFTED INTO SOMETHING DIFFERENT BRINGING UP A VARIETY OF ISSUES BUT LIKE THE RAC FOR BIOSAFETY FOR SYNTHETIC DNA GUIDELINES, WHICH REVIEWS THINGS FOR SAFETY, COULD THE NSABB OR SOME OTHER ADVISORY COMMITTEE BE USEFUL TO JOURNAL EDITORS IN THE REVIEW OF VERY SPECIAL CASES, I DON'T THINK IT WOULD EVER COMPLETELY OVERLOAD THE SYSTEM IF IT HAD TO HAPPEN VERY OFTEN BUT PERHAPS IN THE CASE OF A SURPRISE THAT GETS TO A JOURNAL WHICH DIDN'T GO THROUGH REVIEW PROCESS THE JOURNAL FEELS IS THOROUGH OR COMMITTEE SAYS WE'RE WORRIED ABOUT THIS, WHAT ARE THEY SUPPOSED TO DO? THEY HAVE TO DECIDE ON THEIR OWN, THOSE THREE SCIENTISTS THAT MIGHT HAVE CONSEQUENCES. WHETHER TO TALK ABOUT IT TODAY BUT GOING FORWARD IT'S AN IMPORTANT ISSUE TO THINK ABOUT WHETHER THIS COMMITTEE OR SOME OTHER COMMITTEE MIGHT SERVE IN A ROLE LIKE THAT, IT'S A GOOD POINT. >> THANK YOU. NO, ONE OF THE ISSUES THAT CAME UP WITH THE NSABB AT THE TIME WAS THAT BASICALLY THEY COULD ONLY GET MANUSCRIPTS TO REVIEW THAT HAD BEEN SENT THROUGH CERTAIN CHANNELS. ON THAT NAS COMMITTEE THERE WAS THOUGHT ABOUT MAYBE THERE WOULD BE A BROADER WAY TO VET MANUSCRIPTS, YOU KNOW, TO HAVE A MORE FORMAL SECURITY REVIEW OF THAT SORT. AND THAT MIGHT BE A POSSIBILITY. >> KEN AND JOHN. >> YEAH, WHEN THEY ORIGINALLY -- NSABB WAS DESIGNED TO HAVE A DELIBERATION OVER THE THINGS LIKE THE PAPER BEFORE IT GOT TO THE JOURNALS. IT WAS INTENDED THAT IT WOULD BE LIKE YOUR HUMAN SUBJECTS REVIEW. IF THERE'S ANOTHER PAGE IN THE APPLICATION PROCESS, WHERE YOU GO THROUGH THIS IT WOULD BE KIND OF ROUTINE, NOT TERRIBLY DIFFICULT, IF SOMETHING GOT FLAGGED, THE NSABB WOULD HAVE BEEN AN EXPERT COMMITTEE THAT WOULD ADVISE THE IRE, OR THE IRB, WHATEVER IT'S CALLED THAT'S REVIEWING IT, ON THAT PARTICULAR THING. SO, IT'S IMPOSSIBLE TO STOP PUBLICATION IN "SCIENCE" OR "NATURE" ONCE IT GETS THERE. GIVE IT UP. IT'S NOT GOING TO HAPPEN. MAYBE YOU CAN ADJUST WHETHER OR NOT YOU PUT THE SEQUENCE OF THE PROTEIN IN BUT I DON'T EVEN COUNT ON THAT. BY THE TIME IT'S REACHED THERE, 40 PEOPLE HAVE ALREADY GOTTEN AN E-MAIL WITH THE MANUSCRIPT IN IT. I THINK IT'S A WASTE OF TIME. A COUPLE OTHER THINGS I WANTED TO -- BASED ON WHAT WAS SAID. ANOTHER IS CLASSIFICATION, THE GOVERNMENT, ON BIOLOGIC RESEARCH IS REALLY RARE. IT DOESN'T HAPPEN VERY OFTEN. AND TRYING TO GET SOMETHING CLASSIFIED IS VERY DIFFICULT. FOLLOWING THE ETRAMELIA STUDY REPRODUCED BY MARK BOLLER AT ST. LOUIS IN 2004, SOMETHING LIKE THAT, WE CAME UP WITH ANOTHER STUDY WITHIN THE GOVERNMENT THAT WAS GOING TO BE HIGHLY CLASSIFIED. RELATED TO THREAT. AND IT GOT APPROVED, DESIGNED, I THINK JIM, YOU WERE INVOLVED IN IT PERHAPS. YOU KNOW, IT GOT -- THE WHOLE THING GOT APPROVED, READY TO GO AND GOT DENIED AT THE LAST MINUTE. NOT BY THE COMMAND AUTHORITY IN ALL OF THIS, BUT BY THE PUBLIC AFFAIRS PEOPLE WHO SAID THIS WON'T PASS THE "NEW YORK TIMES" TEST. WHAT DID THEY MEAN? DOESN'T MATTER WHAT OUR INTENT IS. IF YOU WRITE AN ARTICLE, IF JUDY MILLER WROTE AN ARTICLE ABOUT IT, IT WOULD LOOK LIKE WE WERE DOING OFFENSIVE BIOLOGIC WEAPONS WORK AND IT DIDN'T GET DONE FOR THAT REASON ALONE EVEN THOUGH THE INFORMATION WOULD HAVE BEEN ADVANCED OUR BIOSECURITY EFFORTS. AND I THINK THAT IT'S IMPORTANT TO REALIZE THAT VERY LITTLE OF THAT STUFF IS BEING DONE EVEN IN THE CLASSIFIED WORLD. MOST OF WHAT WE'RE DOING IS EVEN IN THE GOVERNMENT, IS REALLY WIDE OPEN. LAST THING I WANTED TO MENTION IS -- THIS HAS TO DO WITH TOM'S AND MARK'S CONCERNS ABOUT REVIEW, AND THAT IS IF YOU OPEN UP REVIEW TO A VERY WIDE NUMBER OF PEOPLE, NOTHING WILL EVER GET APPROVED. TRY TO GET A BUILDING PERMIT TWO MILES FROM THE OCEAN IN CALIFORNIA, FOR EXAMPLE. YOU JUST CAN'T. NOW, SEVERAL YEARS LATER YOU MIGHT BE ABLE TO BUT SCIENCE CAN'T WORK THAT WAY. YOU CAN'T WAIT TWO YEARS FOR A BUILDING PERMIT TO START A PROJECT. IF YOU OPEN A REVIEW PROCESS TO A PUBLIC REVIEW THAT INCLUDES ETHICISTS AND SECURITY PEOPLE AND SCIENTISTS AND EVERYTHING, THERE'S 100% CHANCE NOTHING WILL GET APPROVED. IF IT'S A SERIOUS ENOUGH DISCUSSION ABOUT A SERIOUS ENOUGH PPP. SO KEEP THAT IN MIND. THE LAST IS, AND THEN I'LL SHUT UP, INTERNATIONAL BEST PRACTICES, THAT'S BEEN REFERRED TO BY A NUMBER OF PEOPLE. STU NIGHTINGALE HAD A SUBGROUP OF NSABB BACK IN -- TEN YEARS AGO NOW THAT HAD TWO, MAYBE THREE INTERNATIONAL MEETINGS AT NIH, TO ACTUALLY INVOLVE THE INTERNATIONAL BIOSECURITY, BIOSAFETY COMMUNITY, IN NIH BEST PRACTICES. THOSE GOT DROPPED SOMEHOW ALONG THE WAY. AND I THINK THEY COULD BE -- STUART IS STILL WORKING IN CARRIE'S OFFICE, AT LEAST PART TIME, AMAZING MAN. YOU COULD CERTAINLY ASK HIM HOW THAT WAS DONE AND IF IT'S WORTH REDOING BECAUSE WHAT THEY WERE TRYING TO DO IS NOT DO INTERNATIONAL REGULATION BUT SET NIH OR NSABB STANDARDS AS A BEST PRACTICES TO USE INTERNATIONALLY. >> PLEASE, REACTIONS? >> I SHOULD CLARIFY CLASSIFIED RESEARCH TO SHOW THERE MAY BE ROOM FOR THAT BUT THAT RESTRICTING INFORMATION, UNCLASSIFIED RESEARCH, NOT WHERE WE SHOULD BE. NOT THAT WE SHOULD BE CLASSIFYING MORE RESEARCH, SO -- AND AGAIN BECAUSE I BELIEVE IT'S INEFFECTIVE TO RESTRICT CLASSIFIED INFORMATION, COUNTER TO VALUES, RECIPE FOR SUCCESS, AND INSTANCES WHERE RESTRICTION COULD BE MORE DETRIMENTAL AND INADVERTENTLY INCREASE THE RISK. >> THANKS. JUST TWO QUICK THINGS. IN RESPONSE TO THE DISCUSSION OF JOURNAL POLICIES I THINK MOST -- MANY OF THOSE POLICIES, AND I'M ANXIOUS TO READ ASM ONES, BUT MANY OF THEM WERE FORMULATED IN A PERIOD WHEN EVERYONE WAS FOCUSED ON BIOSECURITY AND THERE WAS NOT MUCH INTEREST OR CERTAIN ABOUT POPULATION LEVEL BIOSAFETY SO THE CONCERN OF ACCIDENTAL RELEASE OF ALTERED ORGANISM. THAT'S AN AREA WHERES THERE'S ROOM FOR IMPROVEMENT. AND THE COMMENT IF THE PUBLIC GETS INVOLVED NOTHING WILL BE APPROVED, I DON'T THINK ANYONE CALLED FOR AN OPEN PUBLIC HEARING WITH ANYBODY JUST COMING UP TO THE MIC AND OFFERING THEIR COMMENTS. I THINK WHAT WAS SUGGESTED WAS TAKING THE EXISTING PROCESS WHICH HAS APPROVED TWO THINGS, I DON'T KNOW IF IT'S DISAPPROVED ANYTHING BUT DID IT QUITE QUICKLY APPARENTLY, WELL, I DON'T KNOW HOW FAST IT WORKED, BUT IT DID APPROVE THINGS. AND MAKING THAT MORE TRANSPARENT TO THE PUBLIC. AND IF THAT MEANS THAT IT DOESN'T GET APPROVED THEN THINK THERE'S A REAL QUESTION WHY IT WAS APPROVED, IF IN SECRET. I'VE BEEN ASSUMING THE SECRET IS BECAUSE OF INSTITUTIONAL CONSIDERATIONS, NOT BECAUSE THERE'S SOMETHING TO HIDE BUT IF JUST MAKING IT OPEN WOULD MAKE IT IMPOSSIBLE TO GET APPROVAL THEN I THINK THERE'S A REAL CONCERN. >> [OFF MICROPHONE]. >> THE REASON THIS STUFF GETS KILLED IS OFTEN BECAUSE OF PERCEPTION, NOT REALITY, NUMBER ONE. AND PUBLIC PERCEPTION MATTERS. AND THE OTHER IS THAT IT HAS TO DO WITH FOREIGN IMPRESSIONS OF WHAT THE UNITED STATES IS DOING. RIGHT NOW, 50% OF OUR ALLIES THINK WE HAVE AN OFFENSIVE BIOWEAPONS PROGRAM. 50%. ABOUT, PLUS OR MINUS. WE DON'T. WE HAVEN'T SINCE, BELIEVE IT OR NOT, NIXON ABOLISHED IT, WHAT, IN -- 1969, OKAY. I WASN'T IN POSITION PREVIOUSLY WHETHER I WOULD HAVE KNOWN IF WE HAD AN OFFENSIVE PROGRAM, AND WE DO NOT. SO IF 50% OF OUR ALLIES, NATO ALLIES BELIEVE THAT WE HAVE AN OFFENSIVE PROGRAM THAT'S SECRET WE HAVE TO BE CAREFUL WITH WHAT WE DO AND WHAT BECOMES PUBLIC BECAUSE DEFENDING AGAINST BIOTHREATS BY DEVELOPING COUNTERMEASURES LOOKS LIKE AN OFFENSIVE PROGRAM AND THINGS WE DON'T DO IS BECAUSE OF PUBLIC CONCERN ABOUT IT. OR POLITICAL CONCERN. >> THIS IS STUFF PUBLISHED IN "SCIENCE" AND "NATURE," NOT SOMETHING WE'RE TRYING TO HIDE. IT'S JUST A MATTER OF WHEN. >> I'VE GOT JOHN AND LU. I WANT TO MAKE A COMMENT ON SOMETHING SAID IN THE EXCHANGE AT ONE POINT, THERE WAS THIS STATEMENT THAT THE PROJECTS THAT WENT THROUGH REVIEW AND WERE FUNDED WERE NOT DISCLOSED. I WANT TO PUSH BACK ON THAT BECAUSE IN FACT THEY ARE DISCLOSED, SAME WAY WE DISCLOSE NIH-FUNDED RESEARCH. THEY ARE ALSO PUBLISHED ON THE S3 WEBSITE WHICH CHRIS AND I PUT UP. I THINK THERE IS ROOM FOR DISCUSSION ON HOW MUCH IS DISCLOSED, TIMING OF DISCLOSURE BUT I WANT TO MAKE SURE THE STATEMENT DOESN'T GO. I'VE GOT JOHN NEXT. >> THE LAST FEW COMMENTS HAVE BEEN GOOD. THIS WAS GOING TO BE A NON-SEQUITUR AND NOW IT'S NOT. I WANT TO GET AT WHAT THE PANELISTS THINK IS THE MOST EGREGIOUS THING OF THE STATUS QUO, NOT NICE TO HAVE BUT WHAT'S THE WORST THING ABOUT WHERE WE ARE TODAY? IS IT THAT WE DID -- THERE WAS NO ANNOUNCEMENT OR THE ANNOUNCEMENT WAS A NEEDLE HIDDEN IN A HAYSTACK, OR WAS IT THAT WE DIDN'T HEAR WHETHER THE VOTE WAS UNANIMOUS OR 10-2, OR WE WANT TO KNOW WHY THE TWO PEOPLE VOTED NO, OR YOU WANT TO GET A MINORITY REPORT AND A MAJORITY REPORT, OR WHAT IS IT THAT WOULD BE THE MINIMUM OR ENOUGH OR WHAT DO YOU WANT? [LAUGHTER] >> LET'S SEE. I THINK THE MINIMUM IN THIS CASE WOULD BE TO UNDERSTAND WHO IS INVOLVED, SKILL SETS INVOLVED, TALKING ABOUT THE PROCESS REVIEW, RIGHT? NOT THE -- CONTENT REVIEW AS WELL? SO FOR THE PROCESS MINIMUM WOULD BE UNDERSTANDING SKILL SETS THAT WERE INVOLVED. AND UNDERSTANDING THE REASONING. I THINK IN THE PAST THESE EXPERIMENTS HAVE BEEN APPROVED WITHOUT FULL DISCLOSURES AND I THINK THERE HAVE BEEN PEOPLE IN THE GOVERNMENT INVOLVED IN THOSE DECISIONS WHO WERE PART OF THOSE EXPERIMENTS. SO I DON'T THINK THEY HAVE BEEN FREE OF CONFLICT. SO UNDERSTANDING THAT THERE'S A CONFLICT-FREE PROCESS WITH THE INVOLVED, AND SWITCHING TO CONTENT, UNDERSTANDING THE REASONING IN DETAIL ABOUT WHY THE GOVERNMENT BELIEVES THE BENEFITS OF THIS WORK JUSTIFY THE RISKS. THEY ARE SAYING WHAT THEY THINK ABOUT BOTH THOSE THINGS. THE GOVERNMENT HAS DECIDED TO CALL THESE EXPERIMENTS ENHANCED POTENTIAL PATHOGENS WHICH SUGGESTS THE GOVERNMENT BELIEVERS THIS WORK IS INCREASING POTENTIAL FOR PATHOGENS TO BECOME PANDEMIC, BY DEFINITION. SO IF THAT'S THE CASE, WHAT DOES THE GOVERNMENT THINK ABOUT THE RISK OF THIS PARTICULAR EXPERIMENT AND WHAT DOES THE GOVERNMENT THINK ABOUT THE BENEFIT OF THIS PARTICULAR EXPERIMENT? NOT THE CLASS OF EXPERIMENTS THAT THEY CAN BROADLY INCREASE BENEFITS FOR VACCINE AND SURVEILLANCE, VACCINE DEVELOPMENT AND SURVEILLANCE, BUT SPECIFICALLY HOW DOES THIS CONTRIBUTE? IS IT WORTH IT? AND I THINK IN EACH CASE MAY BE DIFFERENT. MAYBE THE FIRST TWO CASES WHEN DESCRIBED THAT WAY FULLY DESCRIBED AFTER RISK MITIGATION DEVELOPMENT PROCESS HAS GONE THROUGH MAYBE THAT WILL CONVINCE THIS GROUP AND OTHERS THAT THAT WORK IS CRUCIAL, WE NEED TO DO IT. MAYBE THE SECOND EXPERIMENT IS LESS CRUCIAL AND MORE RISKY AND SHOULDN'T BE DONE. I THINK GETTING MORE SPECIFIC ABOUT WHAT'S BEING PROPOSED I THINK WOULD BE -- YOU SAID THE MINIMUM, I GUESS THAT'S THE MINIMUM, MINIMUM AND MAXIMUM. >> GREAT. SO I THINK DR. BERNARD SAID PUBLIC PERCEPTION MATTERS, HE SAID IT GREAT. PERSONALLY I'M NOT APPLYING FOR NIH STYLE GRANTS AND I'M SATISFIED WITH THE PC3O FRAMEWORK AND LEVEL OF OVERSIGHT. WHAT CONCERNS ME IS NEXT STUDY THAT IS APPROVED THREW THE PCO3 FRAMEWORK, COMMUNICATED IN THE MEDIA, COMMUNICATED TO LISTENERS, I THINK IT'S REALLY IMPORTANT THAT WE HELP OTHERS UNDERSTAND THE CONTEXT WHICH THIS WORK IS DONE. SO THAT WE'RE ABLE TO AVOID SENSATIONALISTIC HEADLINES LIKE IN THE PAST WHICH CAN FURTHER ALARM PEOPLE TO WHERE THEY ARE NOT FULLY UNDERSTANDING THE NEED FOR THIS WORK AND RESPONSIBLE WORK THAT'S GOING ON TO MAKE SURE THIS IS BEING DONE SAFELY AND SECURELY. >> LU, I HAD YOU NEXT. >> I THINK AS I'M LISTENING CLEARLY ONE THING THAT WAS ACHIEVED, YOU SHOULDN'T UNDERESTIMATE, EXTREMELY IMPORTANT IN REGARDS TO A LEVEL WHERE WE DO THE PRE-FUNDING REVIEW WITHOUT ALL THE COMPLICATIONS THAT IT MEANS. MEANS YOU HAVE TO FINE TUNE, HAVE IT IN PLACE AND FINE TUNE THE TRANSPARENCY BUT I THINK THAT TALKING ABOUT RESPONSIBLE COMMUNICATION, RESPONSIBILITY, WHEN WE DISCUSS THIS WITH FUNDING, WHAT REVIEW SHOULD BE, I THINK EVERYBODY WAS PRETTY CLEAR ON THAT IT SHOULD BE DONE UP FRONT BECAUSE THE IMPORTANT PART OF THAT IS THAT THAT MAKES THE SCIENTIST EVEN FROM THE BEGINNING THINKING THAT IS THIS REALLY -- THERE'S DISCUSSION WITH REVIEW COMMITTEE AND SO ON, AFTER THE SCIENTIFIC MERITS THAT MAKES THEM ALL FROM THE BEGINNING THINK AM RAIL GOING TO DO THIS, HOW AM I GOING TO DO IT, DO I HAVE PARTICULAR TRAINING. WE KNOW THE PEOPLE WHO COME THROUGH SO FAR PROBABLY HAVE DONE THIS BEFORE THE FUNDING SO IT'S NOT SO MUCH THAT BUT THEN THAT CULTURE OF RESPONSIBILITY THAT CAN FOLLOW THROUGH TO EVENTUALLY PUBLICATIONS, ONE THING WE'VE ACTUALLY GAINED BY THIS IS REMEMBER "SCIENCE" AND "NATUR EDITORS TELLING US DON'T PUT THIS IN THE SITUATION AGAIN, BECAUSE THAT WAS ABSOLUTELY HORRIBLE. WE NEVER WANT IT TO HELP. YOU CAN HAVE AN ONGOING PROCESS WHILE YOU TALK BIT. I THINK I WOULD PERSONALLY LIKE TO SEE MORE TRANSPARENCY AFTER THE REVIEW PROCESS, MAYBE MORE DETAILS BUT THAT'S WHAT WE'RE SUPPOSED TO BE WORKING ON. >> PAM AND MARK. >> I WANT TO DRILL DOWN A LITTLE BIT ABOUT THE PUBLICATION THING. IT'S CONNECTED TO A WORRY I HAVE ABOUT RISK ASSESSMENT AND DESPITE ALL OUR ONLINE TRAINING WE GIVE TO OUR TRAINEES, I'M NOT SURE A LOT OF THEM WOULD CATCH IF THEY ARE REVIEWING A PAPER, I'M NOT SURE THEY KNOW WHAT TO CHECK IN THOSE BOXES. I'M GOING TO GIVE A FIRST HAND EXPERIMENT, OR RESULT, SOMETHING THAT HAPPENED TO ME RECENTLY. IT GOES INTO THIS ISSUE OF THE DRIVE TO PUBLISH IN THE SO-CALLED HIGH PROFILE JOURNALS WHICH I'M VERY TROUBLED BY ALSO. I'LL TELL YOU A SCENARIO WHERE A PAPER WAS REVIEWED AT ONE OF THOSE JOURNALS, AND ONE OF THE REVIEWERS REQUESTED A BSL3 EXPERIMENT. AND THE AUTHOR OF THE PAPER DIDN'T KNOW THAT IT WAS A BSL3 EXPERIMENT. AND LET'S JUST SAY FOR THE SAKE OF ARGUMENT THAT THAT PERSON WAS IN A FOREIGN COUNTRY. AND THE DRIVE TO PUBLISH WAS SO HIGH, I THINK WE'RE GOING TO SEE MORE OF THAT. AND I WAS SHOCKED. I CONTACTED THE EDITOR OF THE JOURNAL. AND I DON'T THINK THEY WERE EVEN SUFFICIENTLY KNOWLEDGEABLE TO KNOW THAT IT WAS A BSL3 EXPERIMENT. SO THEN I CONTACTED SOMEONE WHO MAYBE USED TO BE ON THIS COMMITTEE AND TRIED TO POINT OUT HOW THIS WAS A DANGEROUS PRECEDENT. I WANT YOU ALL TO BE AWARE THAT MAYBE YOU'VE SEEN THIS ALREADY, FIRST TIME I'VE SEEN IT, I WAS SHOCKED. IT'S GONNA HAPPEN. >> RESPONSES FROM THE PANEL AND WE'LL MOVE ON. >> I WAS GOING TO RESPOND TO MARIA'S COMMENT, RELATES TO WHAT PAM JUST SAID. I REMEMBER AN NSABB MEETING ON THIS TOPIC, YOU CAN HELP ME WHAT THE DATE, MAYBE THREE OR FOUR YEARS AGO, BARBARA JASNEY WAS THERE. SHE CAME TO THE MEETING AND WAS ANGRY AND SAID, I'M SHOCKED AND APPALLED THE GOVERNMENT IS STILL IN THIS POSITION AND WE AT JOURNALS ARE HAVING TO MAKE DECISIONS LIKE THIS. WHEN IS THAT GOING TO CHANGE? IT IS NOT FAIR TO PUT RESPONSIBILITY FOR MAKING DECISIONS LIKE THIS BACK ONTO US AS EDITORS BECAUSE WE DON'T HAVE THE SAME ACCESS TO INFORMATION THAT ALL OF YOU DO. I THINK YOU WERE MAKING DIFFERENT POINTS BUT TO SAY -- >> THAT'S WHAT I WAS REFERRING TO >> I REMEMBER THE SAME THING. >> MARK? >> I'M HERE TO BE EDUCATED, I'M ACKNOWLEDGE ANOTHER AREA OF NO KNOWLEDGE, I KEEP SEEING BOUNDARIES ARE SMALL AROUND WHAT THIS IS, THAT LOOKS SMALL. BUT I WANT TO FIRST ASK JESSICA AND VINCE, DO YOU KNOW WHAT THOSE BOUNDARIES ARE, ON THESE PARTICULAR KINDS OF ORGANISMS? I DON'T. AND THEN I'D LIKE TOM AND MARK TO ADDRESS THAT. AND THEN POTENTIALLY SOME -- I ASK A FEW EXAMPLES, IF THIS WOULD FALL WITHIN THE CATEGORY OF WHAT YOU'RE PROPOSING. >> PLEASE SOMEONE ON THE COMMITTEE HERE CAN CORRECT PLEA IF -- ME IF I'M WRONG. MY UNDERSTANDING OF THE STATEMENT IS LIMITED TO A SMALL AMOUNT OF VIRUSES THAT ACHIEVE BOTH PATHOGENICITY AND TRANSMISSIBILITY, AND ALTHOUGH THERE ARE SOME DISCREPANCIES, SOMETIMES IT'S OR, SOMETIMES IT'S AND, IT NEEDS TO BE CORRECTED IN FUTURE ONES BUT I THINK PERCEPTION AMONG SCIENTISTS IN GENERAL IN SOME ACTUAL PRACTICES IN THE FIELD IS THAT MANY OTHER STUDIES THAT MAYBE AREN'T IN THISLY BEING INTENDED TO BE CAUGHT UP IN THIS ARE NONETHELESS BEING CAUGHT UP IN AT THIS TIME -- IN IT. MAYBE THERE NEEDS TO BE MORE REFINEMENT OR SUBMISSIONS BEING CAUGHT UP IN THIS FRAMEWORK, BUT I THINK JUST BECAUSE THERE'S A DEFINITION ON A PAGE DOESN'T MEAN IT'S HOW IT'S BEING PRACTICED IN REAL LIFE. >> VINCE, DO YOU HAVE COMMENTS? >> I AGREE. THERE ARE VERY FEW PATHOGENS THAT FALL IN THAT CATEGORY. AND FLU IS PROBABLY THE BIGGEST ONE. VERY FEW CAN HAVE THE LEVEL OF VIRULENCE AND TRANSMISSION IT. OTHERS HAVE VIRULENCE, NO TRANSMISSIBILITY. THIS IS A PANEL TO LOOK AT FLU POTENTIALS, PEOPLE OUTSIDE THE AREA FEEL THE SAME WAY. >> SMALLPOX, BUT THAT'S -- (INAUDIBLE) THAT WOULD FALL INTO THE SAME CATEGORY. >> NOTHING IS EVER ERADICATE AS LONG AS YOU HAVE THE SEQUENCE. >> THERE'S A POTENTIAL CASE AT TEXAS A & M. NOT CONFIRMED YET, OF THE CORONAVIRUS. WORKING WITH SOMETHING THAT APPEARS TO BE ABLE TO SPREAD MORE AS WE'RE SITTING HERE, ABOUT READY TO JUMP UP AND RUN OUT OF THE ROOM, YEAH, IS WHEN DOES SOMETHING CHANGE IN THAT CATEGORY, IN OTHER WORDS? WHEN WOULD A PATHOGEN ENTER INTO THAT CATEGORY OF -- AND WHAT WOULD -- WHAT LEVEL OF SORT OF DECISION MAKING WOULD MAKE IT ENTER INTO THE CATEGORY THAT YOU'RE CONCERNED ABOUT? THERE'S GOING TO BE SOMETHING NEW, RIGHT? NOT FLU GOING FORWARD. >> SURE. YEAH, I DON'T THINK IT'S JUST FLU GOING BACKWARD. IF YOU DO A SUFFICIENTLY OUTLANDISH EXPERIMENT, I MEAN, MEANING IF YOU -- THE IDEA IS THAT THE RESULTING THING THAT COMES OUT OF THE EXPERIMENT IS REASONABLY EXPECTED TO BE BOTH TRANSMISSIBLE AND VIRULENT. ANYTHING THAT'S VIRULENT MAKING IT MORE TRANSMISSIBLE, ANYTHING TRANSMISSIBLE MAKING IT MORE VIRULENT. >> OUTLANDISH IS A PROVOCATIVE WORD. EXPERIMENTS, I DON'T THINK IN GENERAL WE DON'T DESIGN THINGS THAT WAY. MAKING A CHIMERIC NEW NOVEL CORONAVIRUS, RIGHT, THE IDEA OF RESCUING IT MORE QUICKLY TO LOOK AT GENETIC BACKGROUND THAT YOU'RE FAMILIAR WITH, WOULD THAT BE -- THAT WAY, OR INTRODUCING MUTATIONS THAT WE KNOW FROM ANOTHER CORONAVIRUS THAT CONFER RESISTANCE TO AN ANTI-VIRAL, WOULD THOSE EVER FALL IN THE CATEGORY YOU'RE TALKING ABOUT? >> SO THE DEFINITION OF THESE EXPERIMENTS IS REALLY CONCRETE AND SPECIFIC, IF THE GUIDANCE FROM OSTP AND HHS. IT WAS SHOWN THREE TIMES A DAY, SAME WORD FOR WORD. I COULD READ IT AGAIN, WE COULD LOOK AT THE SLIDES, I DON'T KNOW IF IT'S WORTH REREADING. IT'S SPECIFIC WILL WHAT A POTENTIAL PANDEMIC PATHOGEN IS DEFINED AS, BASICALLY SATISFIES TWO CRITERIA. LIKELY HIGHLY TRANSMISSIBLENED SPREAD, LIKELY TO CAUSE MORBIDITY AND MORTALITY, AND/OR MORTALITY, THAT'S NATURAL OCCURRING IS DEFINED AS. THIS POLICY DOESN'T APPLY AT ALL TO NATURALLY OCCURRING POTENTIAL PANDEMIC PATHOGENS. IF YOU'RE WORKING ON THE CORONAVIRUS THAT JUST EMERGED IN WUHAN, IT'S NOT RELEVANT. IF YOU WERE TRYING TO INCREASE TO INCREASE VIRULENCE THIS WOULD BEGIN A NEW PROCESS IF NIH WERE FUNDING, UP TO THE REVIEWERS TO DECIDE AS THEY REVIEWED THE SCIENCE IS IT LIKELY -- INTENDED POSSIBLE OUTCOME OR POSSIBLE OUTCOME HERE THAT IT WOULD BE BECOME MORE TRANSMISSIBLE IN THE COURSE OF YOUR WORK, IF SO REVIEWERS ARE ALLOWED TO SAY IT'S OKAY, YOU SHOULD PROCEED BUT THEY SHOULD HAVE DONE THIS REVIEW PROCESS THAT WE DESCRIBED TODAY. WE PROPOSE AMENDMENTS BUT THE POLICY EXISTS, IT'S CLEAR AND SPECIFIC, IT DOES NOT INCLUDE NATURALLY OCCURRING CORONAVIRUS SO WE SHOULD LEAVE THE ROOM KNOWING THAT. WE'RE NOT TALKING ABOUT ANY OF THE WORK THAT'S GOING ON IN THE WORLD RIGHT NOW AROUND NOVEL CORONAVIRUS. >> IF I TRY TO WORK, IT GROWS POORLY IN A MOUSE, TRANSMISSION AND REPLICATION, VIRULENCE, NOW IN A MOUSE IT LOOKS LIKE HUMAN DISEASE, IS THAT IF YOUR IN THE CATEGORY? >> IF IT INCREASES POTENTIAL FOR TRANSMISSIBILITY IN HUMANS, IT'S DOES. I DON'T KNOW THE PROCESS, IT'S NOT BEEN DESCRIBED, BUT IT WOULD GO THROUGH THE PROCESS. >> EVERY SINGLE NEW VIRUS THAT EMERGES WOULD GO THROUGH THESE PROCESSES OF ADAPTATION. >> NO. >> YES, THEY WOULD GO THROUGH ADAPTATION. >> NOT UNLESS YOU DO AN EXPERIMENT LIKELY TO YIELD HUMAN TRANSMISSIBILITY. >> THE STUDY HUMAN VIRUSES IN MOUSE MODEL WOULD LIKELY REQUIRE ADAPTATION TO GROW BETTER. >> THAT'S WHAT WAS GOING ON WITH MERS AT THE TIME OF MORATORIUM, IT WAS FLAGGED, CONSIDERED, THIS PROCESS WASN'T YET IN PLACE, FIRST THIS IS PROBABLY GOING TO DEADAPT TO HUMANS, SECONDLY IT'S IMPORTANT FOR DEVELOPING ANIMAL MODEL, ALLOWED TO GO AHEAD. THAT'S A SUCCESS, NOT THIS POLICY BUT A PREDECESSOR TO THIS POLICY. YES, IT GETS SCRUTINY AS IT SHOULD BUT DOESN'T STOP IT. >> IT'S WORTH NOTING PC3O FRAMEWORK PUBLIC HEALTH EXEMPTION PATHWAYS, THINGS THAT NEED TO BE DONE FOR RAPID SURVEILLANCE, COUNTERMEASURES, THERE ARE PATHWAYS BUILT INTO THE REVIEW POLICY FOR THOSE SORTS OF EXPERIMENTS. >> CARRIE, WE MIGHT BE BEYOND THE RED LIGHT. [LAUGHTER] >> THAT'S WHAT HAPPENS WHEN THEY DON'T PUT AN ACTUAL RED LIGHT IN FRONT OF ME, GERRY. THANKS TO ALL THE PANELISTS. [APPLAUSE] >> YES, THANKS TO ALL THE PANELISTS. SO WE'RE QUICKLY REACHING THE END OF DAY 1. AND I WANT TO ECHO THAT THANKS TO THE PANELISTS, AND THE WILLINGNESS TO GET MANY PERSPECTIVES AND MANY SIDES OF THE DEBATE AND CONVERSATION ON THE TABLE AND THE QUESTIONS THAT WE HAD, DIALOGUE WE HAD, FURTHER AMPLIFIED THE MANY ASPECTS OF THESE CHALLENGES THAT WE'RE GOING TO HAVE OUR WORK CUT OUT FOR US AS WE THINK ABOUT TAKING ON BOTH THESE CHARGES, SPECIFICALLY SHORT-TERM THE PHASE 1 OF THIS DISCUSSION AND DEBATE. THERE'S A LOT OF RESPONSIBILITY AND ACCOUNTABILITY OURSELVES. GIVEN THAT, I WANT TO BEFORE WE CLOSE TODAY JUST OPEN IT UP TO THE BOARD MEMBERS, IF YOU HAVE ANY THOUGHTS, QUESTIONS, ABOUT ANYTHING WE'VE HEARD TODAY, INCLUDING THE LAST PANEL BEFORE WE CONCLUDE IN OUR CONCLUSION TIME AT 5:00 BUT IF WE END SOONER, WE END SOONER. I'LL OPEN IT UP TO COMMENTS, QUESTIONS. I'M SEEING THAT WE DON'T HAVE ANY AT THE MOMENT. I THINK WE'RE ALL KIND OF GRAPPLING WITH THE CHARGE WE RECEIVED TODAY. AND HOW WE'RE GOING TO APPROACH THAT. WE'RE GOING TO NEED TO THINK ABOUT THAT SOME MORE. I WANT TO REMIND EVERYBODY THAT WE WILL RECONVENE TOMORROW MORNING AT NINE A.M. AND REMINDER THAT WE HAVE A PUBLIC COMMENT SESSION AT TWO P.M., TOMORROW AFTERNOON, ON FRIDAY. AND ALSO REMINDER, IF YOU WANT TO MAKE COMMENTS BUT ARE NOT HERE FOR THE PUBLIC, WANT TO PUT YOUR COMMENTS IN WRITING, YOU CAN DO VIA E-MAIL TO DR. JESSICA TUCKER, ALL COMMENTS WRITTEN AND VERBAL WILL BE CONSIDERED AND TAKEN UP BY THE BOARD. SO NOT SEEING ANY MORE COMMENTS, QUESTIONS, WE CONCLUDE DAY ONE.