I'M SAM STANLEY, CHAIR OF NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY. WELCOME TO EVERYONE HERE TODAY. I ALSO WANT TO WELCOME THOSE WHO JOINED ONLINE AND ON THE PHONE. TODAY'S MEETING IS AN IMPORTANT ONE, IT MARKS WHAT I EXPECT IS CULMINATION OF BOARD'S DELIBERATION ON A VERY IMPORTANT TOPIC. AS YOU KNOW THE NSABB HAS BEEN CONSIDERING THE GAIN OF FUNCTION ISSUE FOR SEVERAL YEARS, BUDGET DISCUSSIONS HAVE FOCUSED ON RESEARCH THAT EXAMINES THE TRANSMISSIBILITY OF VIRULENCE OF CERTAIN PATHOGENS. SOME OF THESE STUDIES RESULT IN GENERATION OF PATHOGENS WITH ENHANCED TRANSMISSIBILITY OR VIRULENCE. THERE ARE LEGITIMATE SCIENTIFIC AND PUBLIC HEALTH REASONS FOR CONDUCTING SUCH STUDIES. IT TEACHES HOST PATHOGEN INTERACTIONS AND HELP INFORM DISEASE SURVEILLANCE AND COUNTER MEASURE DEVELOPMENT. HOWEVER, CERTAIN STUDIES RAISE CONCERNS, CONCERNS FOCUS ON GAIN OF FUNCTION STUDY AND GENERATE PATHOGENS WITH PANDEMIC POTENTIAL. THIS ISSUE SURFACED IN 201 # WHEN THE NSABB WEIGHED IN ON COMMUNICATION OF TWO H 5N 1 MAN SCRIPTS THOSE DELIBERATIONS WERE CHALLENGING, WE ULTIMATELY RECOMMEND COMMUNICATING THOSE STUDIES IN FULL AND THE MANUSCRIPTS WERE EVENTUALLY PUBLISHED. SINCE THEN THE DEBATE SHIFTED TO FOCUS ON QUESTIONS ABOUT BIOSAFETY AND BROADER QUESTIONS OF WHETHER SUCH STUDIES SHOULD BE FUNDED AT ALL AND IF THEY ARE, HOW THEY CAN BE CONDUCTED SAFELY. IN OCTOBER 2014 THE NSABB WAS TASKED BY THE US GOVERNMENT ADDRESSING THIS ISSUE. AS PARTED OF THE DELIBERATIVE PROCESS US GOVERNMENT HAS PAUSED CERTAIN GAIN OF FUNCTION STUDIES WHILE WE RE-EVALUATE THE RISK AND BENEFITS OF CONDUCTING THIS TYPE OF RESEARCH. OUR TASK HAS BEEN COMPLEX. IT IS EVOLVED TWO WORKSHOPS HOSTED BY THE NATIONAL ACADEMIES, FORMAL RISK BENEFIT ASSESSMENT THAT EXTENSIVE CONSULTATIONS WITH DOMESTIC AND INTERNATIONAL STAKEHOLDERS. IN ADDITION, THERE HAVE BEEN SIX PUBLIC MEETINGS ON THE TOPIC WHICH ALLOWED US TO COLLECT AND CONSIDER PUBLIC COMMENTS ALONG THE WAY. OUR WORKING GROUP DEVOTED COUNTLESS HOURS TO THIS ISSUE AND MET AT TIMES ON A WEEKLY BASIS. WHILE GROUPS REPORT IS OFFICIALLY STILL A DRAFT, I WANT TO SAY AT THE OUTSET HOW PLEASED AIM WITH THIS DOCUMENT. IT IS TRULY OUTSTANDING. I THINK IT'S THOROUGHLY AND THOUGHTFULLY ADDRESSES A VERY COMPLEX ISSUE AND MAKES VERY SENSIBLE RECOMMENDATIONS. I ALSO WANT TO ACKNOWLEDGE THE CO-CHAIRS OF OUR WORKING GROUP, KEN BERNS AND JOE KANABROCKY. KEN AND JOE DISPLAYED AN IMPRESSIVE DEDICATION TO THIS ISSUE AND I THINK WE OWE A DEAL TO THEIR LEADERSHIP AND VISION. KEN I KNOW YOU WILL BE ROTATING OFF THE BOARD TODAY. YOU WILL BE GREATLY MISSED BUT YOU HAVE DEFINITELY EARNED A BREAK. [APPLAUSE] IN ADDITION TO KEN FOUR OTHER MEMBERS -- PAT FITCH, CHRIS GRANT, CLIFF HOUSTON AND JEFF MILLER, PLEASE JOIN ME IN THANKING THEM. [APPLAUSE] >> Y'ALL HAVE DEDICATED A LOT OF TO THIS COMMITTEE NOT ONLY GAIN OF FUNCTION TASK BUT A NUMBER OF PREVIOUS EFFORTS AS WELL AND YOUR EXPERTISE AND INSIGHTS ARE ESSENTIAL. DR. TABAK, PRINCIPLE DIRECTOR OF NIH IS HERE WITH US TO ACKNOWLEDGE YOUR SERVICE BUT I WANT TO ADD MY THANKS AS WELL. OUR MAJOR ORDER OF BUSINESS TODAY WILL BE DISCUSSING AND FINALIZING OUR DRAFT REPORT. AS I SAID, WHILE I'M PLEASED WITH THE REPORT AND I STILL WANT TO ENCOURAGE ROBUST DISCUSSION, WE HAVE AN OPPORTUNITY TO FIND RETHINK ANY PORTION OF THE REPORTS AND I LOOK FORWARD TO PERSPECTIVE WAS OF THE FULL COMMITTEE. THIS AFTERNOON, WE HAVE ALSO INCLUDED TIME IN OUR AGENDA FOR PUBLIC COMMENTS. WE WELCOME ANYONE IN ATTENDANCE USE THIS PERIOD TO ASK A QUESTION OR OFFER COMMENTS TO THE BOARD. YOU MAY SIGN UP TO OFFER A PUBLIC COMMENT AT THE REGISTRATION TABLE. THOSE YOU WATCHING ONLINE CAN SUBMIT A QUESTION TO THE BOARD AT NSABB@OD.NIH.GOV. WE WILL MONITOR THE INBOX THROUGHOUT THE DAY AND TRY TO S A AS MANY QUESTIONS AS WE CAN. FINALLY BEFORE WE BEGIN I WANT TO SAY A FEW WORDS ABOUT NEXT STEP IN THIS PROCESS. WHILE TODAY'S MEETINGS -- MEETING MAY MARK THE CLOSE OF NSABB DELIBERATIONS THE GAIN OF FUNCTION ISSUE WILL NOT YET BE RESOLVED. OUR RECOMMENDATIONS WILL BE SUBMITTED TO THE US GOVERNMENT T POLICY MAKERS WILL BE ONES TO TAKE POLICY ACTION. I WOULD LIKE TO URGE OUR EX-OFFICIOS AND COLLEAGUES IN THE US GOVERNMENT TO WORK QUICKLY TO DEVELOP POLICY IN THIS AREA. WITH THAT, I WOULD LIKE TO WELCOME Y'ALL AGAIN TO WHAT I BELIEVE WILL BE AN INTERESTING AND IMPORTANT MEETING I WILL HAND IT TO CHRIS VIGGIANI TO INTRODUCE THE BOARD AND REVIEW CONFLICT OF INTEREST RULES. >> THANK YOU, SAM, WHY DON'T WE DO INTRODUCTIONS GOING AROUND THE TABLE STARTING WITH VOTING MEMBERS FIRST. I BELIEVE WE HAVE TWO MEMBERS WHO DIALED IN SO WE'LL CALL ON YOU MOMENTARILY, AFTER THE VOTING MEMBERS INTRODUCED I'LL ASK EX-OFFICIOS TO GATHER THE MICROPHONES TO INTRODUCE YOUR NAME AND AGENCY. LET'S START WITH JAN. >> FIGURE HOW TO TURN IT ON. >> THERE'S A BUTTON. -- >> INTERESTING. I'M JAN LEACH, WITH COLORADO STATE UNIVERSITY. >> I'M JOE MCDADE FORMALLY WITH CDC AND BARRY COLLEGE NOW RETIRED. >> SUSAN WOLF, UNIVERSITY OF MINNESOTA. >> STEVE MORSE, MELMAN SCHOOL OF PUBLIC HEALTH COLUMBIA UNIVERSITY. >> JEAN PATTERSON, TEXAS MEDICAL RESEARCH INSTITUTE. >> GARY RESNICK LOS ALAMOS NATIONAL LABORATORY. >> CARRIE KOEHLER, UNIVERSITY OF TEXAS SCIENCE CENTER. >> SAM STANLEY, STONY BROOK UNIVERSITY. >> CHRIS VIGGIANI, NIH. >> DREW ENDY, STANFORD UNIVERSITY. >> (INAUDIBLE) UNIVERSITY OF TEXAS MEDICAL BRANCH GALVESTON. >> CLIFFORD HOUSTON UNIVERSITY OF TEXAS MEDICAL BRANCH GALVESTON. >> JOE KANABROCKY, UNIVERSITIES OF CHICAGO. >> KEN BERNS FORMALLY UNIVERSITY OF FLORIDA. >> CHRIS GRANT FORMER COMMISSIONER OF HEALTH IN NEW JERSEY AND HERE AS INDIVIDUAL STILL ACTIVE IN PUBLIC HEALTH. Q. PAT FITCH PATEL BIODEFENSE INSTITUTE. >> THANK YOU ALL. I BELIEVE WE HAVE TWO NSABB VOTING MEMBERS ON THE LINE. IS MARGIE LEE WITH US? >> YES. MARGIE LEE, UNIVERSITY OF GEORGIA COLLEGE OF VETERINARY MEDICINE. >> HI, WELCOME. AND IS LOU HAMMARSKJOLD WITH US? >> YES, LOU HAMMARSKJOLD UNIVERSITY OF VIRGINIA. >> GLAD TO HAVE YOU. THANKS, EVERYONE. NOW I WOULD LIKE TO INTRODUCE EXOFFICIO MEMBERS. COULD YOU INTO THE MICROPHONES ON THE SIDE OF THE ROOM YOUR NAME AND YOUR AFFILIATION. >> MORNING DENNIS DIXON NIH NIAID HERE ON BEHALF OF DR. FAUCI. >> GERALD EPSTEIN WHITE HOUSE OFFICE OF SCIENCE AND TECHNOLOGY POLICY. >> SHARLENE WEATHERWAX DEPARTMENTS OF ENERGY. >> WENDY HULL DEPARTMENT OF HOMELAND SECURITY. >> THANK YOU VERY MUCH. >> DANA PERKINS REPRESENTING DR. SALLY STEVENS DEPUTY ASSISTANT SECRETARY FOR POLICY AT HHS. >> GOOD MORNING, ED HUE (INAUDIBLE) DIRECT TRAIT. >> MICHAEL SHAW, CDC. >> CHRISTOPHER PARK DEPARTMENT OF STATE. >> THANKS, EVERYONE, I BELIEVE WE MAY HAVE A COUPLE EX-OFFICIOS WHO DIALED IN. IF THERE ARE ANY ON THE LINE PLEASE ANNOUNCE YOURSELF. >> BRENDA KUKARINI FROM THE DEPARTMENT OF VETERANS AFFAIRS. >> BRENDAN DOYLE FROM THE ENVIRONMENTAL PROTECTION AGENCY. >> ANY OTHERS? >> CAMILLE HARRIS REPRESENTING AN KENSINGER, DEPARTMENT OF INTERIOR USGS. >> THANKS, CAMILLE. THANK YOU. AS A REMINDER TO ANYONE ON THE PHONE PLEASE KEEP YOUR PHONES ON MUTE IF NOT SPEAKING. I'LL BEGIN BY REVIEWING THE CONFLICT OF INTEREST RULES AS WE DO BEFORE EVERY MEETING AS MEMBER OF THE NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY YOUR SPECIAL GOVERNMENT EMPLOYEE AND THEREFORE SUBJECT TO THE RULES OF CONDUCT THAT I A I LOU TO GOVERNMENT EMPLOYEES. THESE RULES AN REGULATIONS ARE IN STANDARDS FOR ETHICAL CONDUCT FOR EMPLOYEES OF THEETH CAM BRANCH. YOU RECEIVED A COPY OF THIS WHEN APPOINTED THE COMMITTEE. AT EVERY MEETING REMINDING YOU THE IMPORTANCE OF FOLLOWING EICS RULES WE LIKE TO REVIEW STEPS WE ACHE AND ASK YOU TO TAKE TO ENSURE THAT ANY CONFLICT OF INTEREST BETWEEN YOUR PUBLIC RESPONSIBILITIESES AND YOUR PRIVATE INTERESTS AND ACTIVITIES ARE IDENTIFIED AND ADDRESSED. TWICE EACH YEAR YOU'RE ASKED TO PROVIDE US WITH INFORMATION ABOUT YOUR PERSONAL PROFESSIONAL AND FINANCIAL INTERESTS, WE USE THIS INFORMATION AS A BASIS FOR ASSESSING WHETHER YOU HAVE ANY REAL POTENTIAL OR APPARENT CONFLICT OF INTEREST THAT COULD COMPROMISE YOUR ABILITY TO BE OBJECTIVE GIVING ADVICE DURING THE COMMITTEE MEETINGS. IF SUCH CONFLICTS ARE IDENTIFIED WE ISSUE A WAIVER OR RECUSE YOU WHERE A PARTICULAR PORTION OF THE MEETING. WE WAIVE CONFLICT OF 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 DEAL ON YOU TO BE ATTENTIVE DURING OUR MEETINGS TO THE POSSIBILITY THAT AN ISSUE ARISES THAT COULD AFFECT OR APPEAR TO AFFECT YOUR INTEREST IN THIS SPECIFIC WAY. IF THIS HAPPENS WE ASK YOU TO RECUSE YOURSELF FROM THE DISCUSSION. IF YOU HAVE ANY QUESTIONS ABOUT RULES OF CONDUCT OR CONFLICT OF INTEREST RULES PLEASE TALK TO ME AND WE CAN PUT YOU IN TOUCH WITH OUR COMMITTEE MANAGEMENT OFFICER. HAPPY TO ADDRESS THEM. SO WITH THAT, I'LL HAND IT BACK TO SAM. THANKS, EVERYONE. >> THANK YOU, CHRIS. SO NEXT I WOULD LIKE TO TAKE SOME TIME TO ACKNOWLEDGE SERVICE OF OUR OUTGOING COMMITTEE MEMBERS, DR. LARRY TABAK, PRINCIPAL INVESTIGATOR OF NIH. -- PRINCIPAL DEPUTY DIRECTOR OF THE NIH. >> GOOD MORNING, THANK YOU, SAM. SO MY REAL GOAL HERE IS TO PROVE TO THE OUTGOING MEMBERS THAT THIS WAS NOT A LIFE SENTENCE. IT'S A TOUGH SELL. I HAVE TO SAY IT'S ALSO WONDERFUL TO SEE THE EX-OFFICIO MEMBERS IN MORE SPACIOUS AND AREA SURROUNDINGS. SO WELCOME TO NIH. NOW I'LL GO BACK ON SCRIPT. SO IT'S A PLEASURE TO ADDRESS THIS COMMITTEE AS SAM HAS SAID, THERE IS SOME SADDENS IN THANKING PEOPLE AS THEY LEAVE THE COMMITTEE. BUT IT ALSO OFFERS A QUICK OPPORTUNITY TO REFLECT ON WHAT THIS GROUP IS ACCOMPLISHED AND IT HAS BEEN CERTAINLY VERY SIGNIFICANT. I FOLLOWED THIS COMMITTEE SINCE 2004, MORE CLOSELY IN RECENT YEARS SINCE TAKING ON A NEW ROLE, BUT DURING THIS TIME YOU HAVE ALL WEIGHED IN ON SOME VERY CHALLENGING SOMETIMES CONTROVERSIAL ISSUES AND YOUR ADVICE REALLY IS CRITICALLY IMPORTANT. NOT JUST TO THE NIH BUT AS YOU CAN TELL BY MEMBERSHIP OF THE EXOFFICIO GROUP THE ENTIRE UNITED STATES GOVERNMENT. AND THE RECOMMENDATIONS THAT YOU HAVE MADE HAVE LED TO REAL THINGS. TANGIBLE POLICY. THAT'S -- THAT CAN'T ALWAYS BE SAID FOR EVERY COMMITTEE THAT WE HAVE. SO YOU CAN BE VERY PROUD OF THAT. I THINK THAT THE LEADERSHIP AND ADVISE THAT THIS BOARD HAS PROVIDED HAS REALLY NOW SET A STANDARD FOR HOW WE THINK ABOUT BIOSECURITY ISSUES AND DUAL USE RESEARCH. AND AGAIN, NOT JUST HERE AT HOME BUT INTERNATIONALLY AS WELL P. OUR INTERNATIONAL PARTNERS ARE INFORMED BY YOUR EFFORTS. SO THOSE OF YOU WHO RETIRE AFTER THIS MEETING, SOME HAVE SERVED SINCE 2008. AND YOU HAVE INVESTED INCREDIBLY LONG HOURS AND DEVOTED A GREAT DEAL OF YOUR PERSONAL TIME TO THIS EFFORT. THE OUTGOING MEMBERS WERE CENTRAL TO THE NSABB REPORT ON STRENGTHENING CULTURE OF RESPONSIBILITY IN THE LIFE SCIENCES, THE RECOMMENDATIONS IN THAT REPORT ARE PARTICULARLY RELEVANT GIVEN RENEWED FOCUS ON LABORATORY SAFETY AND SECURITY, SOMETHING THAT I AM INTIMATELY INVOLVED WITH HERE AT NIH. AND MANY ARE INVOLVED IN DOMESTIC OUTREACH EFFORTS AND IN RECENT YEARS THERE'S BEEN A GAIN OF FUNCTION SET OF ISSUES. SO ON BEHALF OF THE NIH AND ALL FEDERAL AGENCIES THAT THIS BOARD ADVISES I WANT TO OFFER OUR SINCEREST THANKS. WE ARE GRATEFUL FOR YOUR COMMITMENT AND SERVICE. SO YOU GET A PARTING GIFT CONSISTENT WITH THE GOVERNMENT. SO WE'LL PRESENT YOU WITH A CERTIFICATE AND REALLY OBVIOUSLY THIS IS JUST A SMALL TOKEN OF OUR APPRECIATION. AND I GUESS THERE'S GOING FOB A PHOTOGRAPHER, IS THAT TRUE? IT SAYS A PHOTOGRAPHER. IF ANYBODY HAS AN iPHONE OR -- NEVER MIND. YOU DIDN'T WANT A PICTURE WITH ME ANYWAY. AND AGAIN, IF I COULD NOW HAVE EACH OF YOU COME UP IN TURN, I WILL PRESENT YOU WITH THIS CERTIFICATE, DR. KEN BERNS. [APPLAUSE] DR. PATRICK FITCH. [APPLAUSE] >> MS. CHRISTINE GRANT. [APPLAUSE] >> THE FOLLOWING PARTICIPANT HAS ISSUED THE -- ENTERED THE CONFERENCE. >> DR. CLIFF FORD HOUSTON [APPLAUSE] >> AND I ALSO WANT TO ACKNOWLEDGE THE SERVICE OF DR. JEFFREY MILLER WHO I UNDERSTAND WAS UNABLE TO JOIN TODAY. SO BEFORE I HAND THIS BACK OVER TO DR. STANLEY, I WANT TO REMIND OUR RETIRING MEMBERS THAT YOUR WORK IS NOT QUITE YET DONE. YOU STILL HAVE TODAY'S MEETING AND OBVIOUSLY THIS IS A VERY IMPORTANT ONE. THERE YOU ARE. HELLO. IT'S MY FAULT, IN MY HASTE I JUST -- WE WANT TO DO A GROUP PICTURE. OF THE OUTGOING MEMBERS. THERE WERE FOUR IN ATTENDANCE. COULD Y'ALL COME BACK UP? THANK YOU. IT SAID THERE WAS -- A (OFF MIC) [APPLAUSE] >> OBVIOUSLY TODAY YOU'RE GOING TO BE DEALING WITH THE TOPIC OF TODAY GAIN OF FUNCTION. THIS IS OBVIOUSLY VERY CHALLENGING AND THE DELIBERATIVE PROCESS THAT YOU HAVE UNDERTAKEN IS UNPRECEDENTED IN A VARIETY OF WAYS. I THINK MANY OF YOU APPRECIATE THIS. IT'S INVOLVED A FORMAL RISK BENEFIT ASSESSMENTS. IT'S INCLUDED IN ETHICS ANALYSIS. IT'S BEEN INFORMED BY WORKSHOPS HOSTED BY THE NATIONAL ACADEMIES, AND OBVIOUSLY THERE HAVE BEEN COUNTLESS CONSULTATIONS WITH STAKEHOLDERS. ENGAGING IN BROAD CONSULTATION HAS ENRICHED THE PROCESS AND IS DEMONSTRATED YOUR COMMITMENT TO THE TASK AND I THINK IT'S ALSO ALLOWED YOU TO DRAFT AN EXCELLENT REPORT. I UNDERSTAND YOU MAY CONSIDER FINALIZING SOME RECOMMENDATIONS TODAY. I CERTAINLY LOOK FORWARD TO THAT FINAL REPORT AND I THINK THAT IT IS FITTING THAT OUR RETIRING MEMBERS WILL BE ABLE TO FINISH THIS -- SEE THE PROJECT TO THE END. AGAIN, ON BEHALF OF FRANCIS AND MYSELF, THANK YOU ALL VERY MUCH. [APPLAUSE] >> THANK YOU VERY MUCH, LARRY. OUR NEXT ROOT OF BUSINESS IS TO APPROVE THE MINUTES FROM THE LAST MEETING. I UNDERSTAND CRAIG AND TERRY HAVE REVIEWED THE MINUTES, TERRY DO YOU HAVE ANY COMMENTS OR EDITS TO THE MINUTES? >> NO COMMENTS. >> DO ANY MEMBERS HAVE EDITS OR COMMENTS OR CORRECTIONS TO THE MINUTE? CAN I HAVE A MOTION TO APPROVE? SECOND, STEVE, ALL IN FAVOR SIGNIFY BY SAYING AYE. ANY OPPOSE? MOTION CARRIES UNANIMOUSLY. ALL RIGHT. NEXT I WOULD LIKE TO INTRODUCE DR. JERRY EPSTEIN, ASSISTANT DIRECTOR FOR BIOSECURITY EMERGING TECHNOLOGIES FROM THE WHITE HOUSE OFFICE OF SCIENCE AND TECHNOLOGY POLICY. PREVIOUSLY JERRY WAS EX-OFFICIO MEMBER OF THE NSABB HE KNOWS THIS COMMITTEE WELL AND FOLLOWED THE GAIN OF FUNCTION DELIBERATIONS CLOSELY. JERRY'S NEW POSITION OSTP HE WILL BE HELPING COORDINATE GOVERNMENT'S POLICY EFFORT FOR GAIN OF FUNCTION STUDIES. TODAY WE'LL PROVIDE A BRIEF BACKGROUND ON THE DELIBERATIVE PROCESS TO DATE AND SAY FEW WORDS OBJECT THE NEXT STEPS IN THE PROCESS. JERRY. >> THANK YOU VERY MUCH. PRESENTATION, DO I NEED TO -- SO THANK YOU FOR GIVING ME THE OPPORTUNITY TO TALK WITH YOU HOW WE GOT TO HERE AND WHERE WE'RE GOING FROM HERE. DR. STANLEY HAS PREVIEWED THAT SO I'M NOT SURE YOU LEARNED ANY SHOCKING REVELATIONSES IN THIS TALK BUT I DID WANT TO GO THROUGH ELABORATION AND COLOR COMMENTARY ON THIS PROCESS. THOSE WHO HAVE -- SLIGHTLY MORE ACCURATE TITLE ON THIS VERSION OF THE SLIDE THAN THE AGENDA THAN THE VERSION IN THE HAND OUT. SO JUST TO STEP BACK A LITTLE BIT, I WANTED TO SAY A LITTLE BIT ABOUT WHAT THE OVERARCHING CHALLENGE WE'RE FACING WHY WE'RE GOING THROUGH THIS. THE QUESTION WE ASK OURSELF AND WORKING WITH YOU AND THE GOVERNMENT AND STAKEHOLDERS IS TO FINDS OUT HOW TO RELIABLY IDENTIFY AND WHERE NECESSARY IF POSSIBLE MITIGATE RISK WHILE AT THE SAME TIME PROTECTING THE OTHER VALUES AND OBJECTIVES WHICH IS THE REASONS WHY WE'RE CONDUCTING THESE ACTIVITIES IN THE FIRST PLACE. ECONOMY, DISCOVERY INNOVATION PUBLIC HEALTH, NATIONAL SECURITY AND RANGE OF OTHER INTERESTS SO WE HAVE A LOT OF OBJECTIVES WE'RE TRYING TO ACCOMPLISH AND THE POINT IS HOW CAN WE ACCOMMODATE ALL THAT AND SATISFY AS MANY AS POSSIBLE AT THE SAME TIME. NSABB ENGAGEMENT IN THIS ISSUE IN TWO ROUNDS, ROUND 1, AS DR. STANLEY INDICATED THE BOARD WAS ASKED TO REVIEW TWO PAPERS DESCRIBING HOW TO MAKE HIGHLY PATHOGENIC AVIAN INFLUENZA TRANSMISSIBLE BETWEEN MAMMALS VIA THE RESPIRATORY ROUTE IN LATE 2011 AND 2012. NSABB FIRST CONSIDERED THESE PAPERS AND RECOMMENDED THAT THEY BE PUBLISHED IN REDACTED FORM. NOT ALL THE DETAILS THAT WERE CONTAINED IN MANUSCRIPTS THE THOUGHT SHOULD BE MADE PUBLIC WIDELY BUT CERTAINLY THE CONCLUSIONS AND IMPORTANT ASPECTS IN THE PAPERS OUGHT TO BE NOT ALL THE DETAILS. THE BOARD REVISITED THAT IN MARCH 2012 IN PART BECAUSE THEY WERE REVIEWING REVISED VERSIONS OF THE PAPER BE AMOSLY SIGNIFICANT THE BOARD FOUND OUT THERE WAS NO MECHANISM BY WHICH THAT REDACTED DISTRIBUTION COULD BE ACCOMPLISHED. THAT WASN'T SOMETHING THAT COULD BE DONE LEGALLY AND THERE WERE ALL SORTS OF LOGISTIC AND PRACTICAL ISSUES AS WELL SO THAT OPTION WAS TAKEN OFF THE TABLE AN AT THAT POINT THE BOARD DECIDED TO RECOMMEND PUBLICATION OF BOTH PAPERS. ONE UNANIMOUSLY, THE OTHER WITH A 12 TO 6 VOTE. AT THE SAME TIME, THE US GOVERNMENT ISSUED ITS POLICY ON THE OVERSIGHT OF DUAL USE RESEARCH OF CONCERN. THIS IS THAT CATEGORY OF EXPERIMENTS INVOLVING CERTAIN PATHOGENS, INVOLVING CERTAIN TYPES OF ACTIVITIES, AND RESULTING IN CREATION OF RESEARCH OR KNOWLEDGE THAT CAN BE REASONABLY ANTICIPATED TO BE DIRECTLY HAVE POTENTIAL TO BE DIRECTLY APPLIED. THIS IS THE POLICY THE UNITED STATES ISSUED TALKING TO ITSELF. THIS IS TO US GOVERNMENT FUNDING AGENCIES, OUTLINED A MECHANISM BY WHICH THESE PARTICULAR PROJECTS WARRANTED FURTHER ANALYSIS, CAN BE IDENTIFIED AND STEPS THAT WILL BE TAKEN IN ORDER TO MAKE FUNDING DECISION TO GO AHEAD. THEN IN JUNE THOSE PAPERS AT THE NSABB REVIEWED OR PUBLISHED. NSABB RETURNED TO THE ISSUE U IN MIDDLE 2014, AT THIS TIME LARGELY PROMPTED BY HIGHLY VISIBILITY LABORATORY BIOSAFETY AND BIOSECURITY INCIDENTS AFFECTING THE MOST FAMILIAR RESEARCH INSTITUTIONS IN THE UNITED STATES. HAVING BIOSAFETY PRACTICES IN CODIFIED AND HAVING EXCELLENT STAFF AND PEOPLE CERTAINLY FAMILIAR WITH HOW TO HANDLE ORGANISMS CAN STILL HAVE CLASSES OCCUR, DEPARTMENT OF HEALTH AND HUMAN SERVICES TO ASK THE US GOVERNMENT TO REASSESS THE RISK BENEFIT CALCULUS IMPLICIT WHEN DECISIONS TO FUND SOME POTENTIALLY HIGHLY CONSEQUENTIAL RESEARCH ACTIVITIES WERE MADE. THOSE LAPSES WERE NOT DIRECTLY ASSOCIATED WITH GAIN OF FUNCTION EXPERIMENTS BUT THE FACT THEY HAPPENED CAUSED THE GOVERNMENT TO STEP BACK AND SAY THIS IS AN ISSUE THAT WE NEED TO SPEND MORE TIME LOOKING AT. THERE WERE MULTIPLE STAKEHOLDER ROUTES CALLING FOR SCIENCE BASED DELIBERATION, I HAVE SEEN A FEW HERE, ACONTACTING INTERNATIONAL ATTENTION, AMONG OTHER GROUPS EUROPEAN ACADEMY SCIENCE ADVISORY COUNCIL LOOKED AT THIS CATEGORY OF RESEARCH. AND THE HIGHEST CONCERN AT THE TIME WAS ABOUT PATHOGENS THAT HAD THE POTENTIAL TO CREATE PANDEMICS VIA RESPIRATORY TRANSMISSION AND PARTICULAR MERS SARS AND INFLUENZA. SO AS -- AFTER THIS TRIGGERED BY THIS INCIDENCE AND WITH DISCUSSIONS UNDERWAY, THE US GOVERNMENT ANNOUNCED OCTOBER 17th, 2014 INITIATION OF THIS DELIBERATIVE PROCESS WHICH WILL BE ENDING TODAY OR SHORTLY THEREAFTER WHEN NSABB COMES TO ITS CONCLUSION. THIS PROCESS WAS EFFORT TO LOOK AT POTENTIAL RISK AND BENEFITS WITH A CERTAIN CATEGORY OF SO-CALLED GAIN OF FUNCTION STUDIES IN ORDER TO INFORM THE DEVELOPMENT OF U.S. POLICY GOVERNING THIS CATEGORY OF RESEARCH. AND PENDING THE ADOPTION OF THAT NEW POLICY, THE GOVERNMENT PUT A FUNDING MORATORIUM IN PLACE ON CERTAIN TYPES OF ACTIVITIES, WITH THESE PATHS GENERALS INFLUENZA, SARS AND PERSONA TRIGGERED THE PROCESS THAT WE HAVE BEEN ON SINCE MID 2014, THE KEY STAKEHOLDERS IN THIS WERE NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY, IT WAS ASKED TO PROVIDE THE U.S. GOVERNMENT WITH RECOMMENDATIONS ON POLICY FOR FUNDING AND CONDUCT OF THIS RESEARCH. IT HAS BEEN INSTITUTED TO SERVE AS OFFICIAL FEDERAL ADVISORY BODY PROVIDING ADVICE ON AREAS OF DUAL USE RESEARCH WHICH GAIN OF FUNCTION IS ONE. AND AS A FELLOW ADVISORY COMMITTEE, INSTITUTED UNDER THE FEDERAL ADVISORY COMMITTEE ACT THE NSABB OPERATES WITH THE TRANSPARENCY AND PUBLIC INPUT REQUIREMENT AS DO ALL OTHER FEDERAL ADVISORY COMMITTEES. SO HAVING NSABB IN THIS ROLE BUILT IN SOME MEASURE OF TRANSPARENCY AND OPENNESS. AT THE SAME TIME THE NATIONAL ACADEMIES WERE ASKED TO SUPPORT THIS PROCESS BY WORK OUT PUBLIC CONFERENCES ONE HELD EARLY IN THE CONDUCT OF THE DELIBERATIVE PROCESS, KICKED OFF OCTOBER 2014, THE FIRST NATIONAL ACADEMIES WORKSHOP DECEMBER OF THAT CLEAR TO INTRODUCE TOPICS THAT WERE TO BE DISCUSSED COME BEFORE CONSIDERATION OF THE BOARD, HAVE TAKE HOLDERS PROVIDE DIFFERENT PERSPECTIVES AN OFFER OPPORTUNITY FOR PUBLIC COMMENT. AND ACADEMIES ARE TO AND HAVE SOMERIES OF PUBLIC DISCUSSIONS OF THESE MEETINGS. THESE ARE NOT NATIONAL ACADEMY STUDIES THEY DEVELOP CONSENSUS RECOMMENDATIONS ON THEIR OWN, WORKSHOPS HELD TO SUPPORT THIS PROCESS AND THE ACADEMY REPORTS REFLECT CONTENTS AND DISCUSSION OF THOSE WORKSHOPS AND THE SECOND OF THESE WORKSHOPS WAS HELD IN MARCH OF THIS YEAR. AFTER THE NSABB WORKING GROUP RELEASED ITS FIRST DRAFT RECOMMENDATIONS, SECOND ACADEMY CONFERENCE PROVIDED AN OPPORTUNITY FOR NSABB MEMBERS AN PUBLIC TO GIVE FEEDBACK ON WHAT WE SEE -- GIVE AND RECEIVE FEEDBACK ON WORK GROUP'S FIRST DRAFTS. THE NSABB PROCESS WAS TO FORM THIS WORKING GROUP WHICH IS REPORTING OUT RECOMMENDATIONS TODAY. THE WORK GROUP ASKED TO ADVISE ON CONSTRUCT OF A RISK BENEFIT ASSESSMENT WHICH WOULD INFORM THE REST OF THE PROCESS. WITH THAT ASKED TO DEVELOP RECOMMENDATIONS BEFORE THE NSABB TODAY ON WHAT THE US GOVERNMENT SHOULD DO IN TERMS OF POLICY GOVERNK THIS AREA. THE NIH AT THE SAME TIME SUBSEQUENT TO THE NSABB DELIVERING FRAMEWORK FOR THE RISK BENEFIT ASSESSMENT WHICH IT DID IN MAY OF 2015 WITH CONTRACT SCIENTIFIC WHICH THEN PROCEEDED CONDUCT CONDUCT THIS RISK BENEFIT ANALYSIS OF WIDE RANGE OF TYPES OF RISK, WIDE RANGE OF TYPES OF BENEFITS FROM GAIN OF FUNCTION RESEARCH. FINALLY NSABB CHARGE TO ADOPT AND TRANSMIT POLICY RECOMMENDATIONS BASED ON THE PUBLIC INPUT IT HEARD, BASED ON ACADEMY STUDIES, BASED ON THE GRIFFIN SCIENTIFIC REPORT AND TRANSMIT THAT FORMALLY TO THE US GOVERNMENT. SO NOW IT'S OUR TURN. THE E OFFICIOS CONTRIBUTED TO THIS PROCESS RECOGNIZING THAT IT IS THE BOARD'S -- GOVERNMENT ASKED THE BOARD FOR OUTSIDE INPUT SO IT'S A BOARD THAT DELIBERATED ON THE RECOMMENDATIONS BUT I CAN SPEAK FOR OTHER EXOFFICIOS WE THOUGHT IT WAS OUR JOB TO PROVIDE FACTUAL OR TECHNICAL ADVICE TO THE BOARD AND HELP MAKE RECOMMENDATIONS WHATEVER THEY MIGHT BE SOMETHING THAT COULD BE MOST USEFULLY ADOPTED OR TRANSMITTED TO THE GOVERNMENT. AND WE ARE NOW TO THE POINT THE BOARD IS ABOUT TO RECOMMEND A PROPOSAL. THE WHITE HOUSE WILL TRIGGER A POLICY PROCESS TO EVALUATE THE RECOMMENDATIONS THAT IT RECEIVES. MY OFFICE, OFFICE OF SCIENCE AND TECHNOLOGY POLICY ALONG WITH NATIONAL SECURITY COUNSEL WILL LEAD ENTERAGENCY EFFORT DRAFTING POLICY IN THIS AREA. IT WILL BE BASING POLICY ON THE ENTIRE DELIBERATIVE RECORD. WE WILL TAKE THE NSABB RECOMMENDATIONS, WE WILL ALSO BE ABLE TO LOOK AT THE NATIONAL ACADEMY SESSIONS, THE GRIFFIN RISK BENEFIT ANALYSIS AN ENTIRE RECORD OF PUBLIC COMMENT ACCUMULATING OVER THAT PERIOD. I WOULD ADD EVEN THOUGH THE NSABB IS GOING TO ISSUE ITS FINAL RECOMMENDATIONS EITHER TODAY OR SUCH TIME IT COMES TO CLOSURE AND AT THAT POINT PUBLIC COMMENT WON'T BE IN A POSITION TO INFLUENCE THE NSABB, THEY WILL HAVE MADE THEIR RECOMMENDATIONS AND TO THE WHITE HOUSE BE KEEPING PUBLIC COMMENT RECORD OPEN SO IF THERE IS A COMMENT ON THE FINAL NSABB REPORT THERE'S STILL A PLACE FOR THAT TO GO AND AGENCIES AND OFFICIALS EVALUATING POLICY WILL BE ABLE TO DRAW ON THAT AS WELL. THEN AT SUCH TIME WE ARE ABLE TO DEVELOP A NEW POLICY, THIS WILL SUPERSEDE THE EXISTING FUNDING CLAUSE. WE HEARD DR. STANLEY'S URGENT REQUEST FOR QUICK PROCESS, WE RECOGNIZE THINGS ARE DEPENDING ON OUR ABILITY TO COME TO CONCLUSION AND PUT IN PLACE WHATEVER IS GOING TO FOLLOW THE PAUSE, WE TAKE THAT SERIOUSLY. I'M NOT ABLE TO GIVE A DEADLINE AT THIS POINT WE ANTICIPATE IT WILL BE A MATTER OF MONTHSES, CERTAINLY SOMETHING THAT I DON'T THINK ANYBODY WANTS TO PERMIT TO GO TO NEXT ADMINISTRATION. WE WANT TO GET THIS DONE BEFORE TRANSITIONS HAPPEN SO CERTAINLY DONE BY THEN, HOPEFULLY FASTER. AND WE RECOGNIZE THERE'S A GREAT PREMIUM GETTING THINGS DONE QUICKLY BUT DON'T WANT TO GO ANY QUICKER THAN WE NEED TO. WE WANT TO GET IT RIGHT. THE OTHER FEDERAL OFFICIALS WHO ARE PARTICIPATING WILL INCLUDE THOSE WHO HAD A GREAT DEAL OF EXPERIENCE WITH THIS PROCESS AS IT IS PROCEEDED BUT AS EVERY FEDERAL POLICY BUBBLING UP TO SENIOR LEVELS WE WILL BRING IN SENIOR OFFICIALS A T THE AGENCIES AND BY THE TIME WE COME OUT WITH THE RESULT IT'S SOMETHING THE ENTIRE US GOVERNMENT WILL STAND BEHIND. SO THANKS TO THE NSABB AND WORKING GROUP VERY MUCH FOR THE EFFORT TODAY. FOR GIVING US THE RECOMMENDATIONS AND TALK TO MY FRIENDS ON THE LEFT HERE AND SAY WE HAVE A LOT OF WORK TO DO. THANK YOU FOR HEFT AND I'M IN A POSITION TO TAKE A FEW QUESTIONS IF THERE ARE ANY. >> ANY QUESTIONS? COMMITTEE MEMBERS ANYBODY? NOW TO A SESSION ON REVIEWING AND HAVE DISCUSSION ON THE DRAFT REPORT AND JOE KEN BRO KY CO-CHAIR OF THE NSABB WORKING GROUP WILL PRESENT THE WORKING GROUP'S DRAFT REPORT. JOE KANABROCKY. >> THANK YOU, SAM, GOOD MORNING TO EVERYONE HERE. MY NAME IS JOE KANABROCKY, I'M A CO-CHAIR OF THE WORKING GROUP THAT WAS TASKED WITH PROVIDING A DRAFT RECOMMENDATION ON APPROACH HOW TO REVIEW AND APPROVE GAIN OF FUNCTION STUDIES. I HAD THE PLEASURE OF WORKING WITH DR. KEN BERNS AS CO-CHAIR ON THIS COMMITTEE AND I HAVE LEARNED A LOT FROM KEN DURING THE PROCESS FOR SURE. NOW ADDRESS MEMBERS OF THE WORKING GROUP WHO REALLY SOME OF THE MOST CHALLENGING AND STIMULATING INTELLECTUAL DISCUSSIONS THAT HAVE BEEN INVOLVED WITH. SO AGAIN, THANKS TO THE WORKING GROUP. CHRIS AND THE NIH STAFF WE COULDN'T HAVE DONE THE WORK WITHOUT YOUR HELP. AND OF COURSE EX-OFFICIO WAS HELPING KEEP US ON TRACK. SO -- SOMETHING IS WRONG HERE. VERY GOOD. THANK YOU. SO MY JOB IS TO TO PROVIDE YEAR VIEW OF NSABB REPORT, IT OUTLINES ANALYSIS FINDINGS AND DRAFT RECOMMENDATIONS FOR THE EVALUATION AND OVERSIGHT OF THE PROPOSED GAIN OF FUNCTION RESEARCH. WE RECEIVE A GREAT DEAL OF FEEDBACK FOLLOWING THE REGULARS OF OUR DRAFT REPORT AND THE JANUARY NSABB MEETING WHICH MANY OF YOU PARTICIPATED AND WE GOT GREAT FEEDBACK AT NATIONAL ACADEMIES WORKSHOPS THE LAST OF I WITH WAS HELD IN MARCH. SINCE THOSE MEETINGS THE REPORT HAS UNDERGONE CONSIDERABLE REVISIONS. PARTICULARLY IN THE FINDINGS AND DRAFT RECOMMENDATIONS. SOME OF THOSE REVISION WERE REALLY SMALL TWEAKING OF THE LANGUAGE BOTH OF THEIR -- SOME SUBSTANTIVE ADDITIONS MADE TO THE DRAFT RECOMMENDATIONS AS WELL. I THINK THE WORKING GROUP IS PLEASED WITH THE -- WITH THE PROCESS AND BUT LOOKING FORWARD TO FEEDBACK FROM THE REST OF THE BOARD TODAY. WANT TO REMIND EVERYONE THE UPDATED DRAFT REPORT IS AVAILABLE ON THE NSABB WEBSITE AND ALL OF YOU IN ATTENDANCE SHOULD HAVE A COPY OF THE LATEST VERSION IN YOUR PACKETS. SO AS WAS DESCRIBED EARLIER, NSABB CHARGE WAS TWO FOLD. FIRST AS PART OF THE DELIBERATIVE PROCESS, NIH COMMISSION FORMAL RISK BENEFIT ASSESSMENTS TO HELP INFORM THE NSABB DELIBERATIONS. SO OUR FIRST TASK WAS TO ADVISE DESIGN AND CONDUCT OF THIS ASSESSMENT, THE BOARD DELIVERED ON THIS TASK IN MAY OF 2015, A YEAR AGO WITH OUR FRAMEWORK CONDUCTING RISK AND BENEFIT ASSESSMENTS OF GAIN OF FUNCTION RESEARCH. OUR SECOND TASK WAS TO PROVIDE RECOMMENDATIONS TO THE GOVERNMENT ON CONCEPTUAL APPROACH FOR EVALUATING GAIN OF FUNCTION STUDIES. THE FOCUS OF MY PRESENTATION THIS MORNING WILL BE ON THE SECOND TASK OF THE NSABB. TO ACCOMPLISH OUR TASKS WE FOCUSED ON FOUR MAJOR AREAS. WE EXAMINE RISK AND BENEFITS ASSOCIATESSED WITH GAIN OF FUNCTION STUDIES. THIS WAS INFORMED BY RISK BENEFIT ASSESSMENT THAT WAS CONDUCTED BY GRIFFIN SCIENTIFIC. WE ALSO FOCUSED A LOT OF ATTENTION ON ETHICAL ISSUES ASSOCIATESSED WITH FUNDING AND CONDUCT OF GAIN OF FUNCTION RESEARCH. WE CONSULTED WITH NUMBER OF ETHICISTS AND PROFESSOR MICHAEL -- TO ADDRESS THE WHITE PAPER ANALYZING THE KEY ISSUES. WE ALSO CURRENT POLICY LANDSCAPE, WE RECEIVED BRIEFINGS FROM VARIOUS SUBJECT MATTER EXPERTS, SOME OF THE DOMESTIC AND INTERNATIONAL POLICIES THAT ARE IN PLACE TO DETERMINE WHETHER HOW TO APPLY GAIN OF FUNCTION STUDIES. IN PART WE ALSO SAUDI VERSE STAKEHOLDER PERSPECTIVES. COMMENTS WERE RECEIVED IN WRITING AS WELL AS IN WHAT WE HEARD AT NSABB MEETING AS WELL AS NATIONAL ADAD MYS WORKSHOPS INCREDIBLY VALUABLE TO THE WORK WE DO. THE FIRST TASK IS TO ADVISE DESIGN OF THE GRIFFIN RISK BENEFIT ASSESSMENTS. IN MAY OF 2015 WE ISSUED O YOU ARE REPORTS GUIDING THAT ANALYSIS. THE FORMER PUBLISHED DESCRIBED THE PATHOGENS AND PATHOGEN CHARACTERISTICS THAT SHOULD BE EXAMINED IN THE STUDY. CATEGORIES OF RISKS AND BENEFITS THAT SHOULD BE ASSESSED. SCENARIOS AND EVENTS THAT SHOULD BE EVALUATED. AND NETTED DOGS THAT SHOULD BE CONSIDERED. WITH THIS FRAMEWORK IN MIND THERE'S A STUDY COMPLETED IN APRIL AND RAISED IN JUST OVER A THOUSAND PAPERS. MY NOTES SAY ALMOST FOUR POUNDS OF PAPER. GRIFFIN'S RISK BENEFIT ANALYSIS IS THOROUGH AND VERY WELL DONE. THE ANALYSIS SYSTEM THREE MAJOR COMPONENTS. FIRST THERE IS THE BIOSAFETY RISK ASSESSMENT, WHICH FOCUSED ON RISKS AASSOCIATED WITH LABORATORY ACCIDENTSES. SECONDS IS BIOSECURITY RISK ASSESSMENT WHICH EXAMINES RISK WITH THREATS TARGETING LABORATORIES. PART OF THIS ANALYSIS GRIFFIN EXAMINED RISKS ASSOCIATESSED WITH THE MISUSE OF RESEARCH INFORMATION. THEY DEVOTED SIGNIFICANT ATTENTION TO POTENTIAL BENEFIT OF GAIN OF FUNCTION RESEARCH. NEARLY HALF OF THE GRIFFIN REPORT EXAMINES POTENTIAL BENEFITS INCLUDING GAIN OF FUNCTION RESEARCH THE SAME OR SIMILAR BENEFITS. GRIFFIN STUDY IT IS MOST COMPREHENSIVE ANALYSIS OF THIS TYPE TO DATE. THEY REPORT SUPPLEMENTARY MATERIAL CAN BE FOUND AT THE GIVEN WEBSITE AS WELL AS THE NSABB WEBSITES. WHILE THE REPORT IS LONG AND RATHER TECHNICAL IN PARTS, I RECOMMEND YOU READS IT. ATLANTIC SEEK OUTS PARTS THAT MAY INTEREST YOU IN PARTICULAR. THERE'S A LOT OF EXCELLENT INFORMATION IN THAT REPORT. REITERATING THE DISCUSSIONS ALREADY AT PREVIOUS MEETINGS I THOLED I WOULD DESCRIBE HOW THEY USE THE RISK BENEFIT ASSESSMENTS, IT HELPED US IN A NUMBER OF IMPORTANT WAYS, IT ALLOWED US TO UNDERSTAND THE DIFFERENT RISKS ASSOCIATESSED WITH RESEARCH INVOLVING PATHOGENS AND CERTAIN GAIN OF FUNCTION EXPERIMENTS. IN DOING SO ALLOWED US TO DISTINGUISH GAIN OF FUNCTION STUDIES THAT RAISED SIGNIFICANT CONCERNS FROM THOSE THAT DO NOT. AS YOU WILL SEE FROM OUR RECOMMENDATIONS, WE TRIED TO FOCUS ON THE SUBSETS OF GAIN OF FUNCTION STUDIES THAT ENTAIL THE MOST SIGNIFICANT RISKS. THE RISK BENEFIT ANALYSIS HELP IDENTIFY AND EVALUATE POTENTIAL BENEFITS OF GAIN OF FUNCTION STUDIES AND LASTLY THE RISK BENEFIT ANALYSIS ALLOWED THE NSABB TO CONSIDER POTENTIAL BENEFITS DERIVED FROM GAIN OF FUNCTION STUDIES COMPARED WITH THOSE THAT MAYBE ACHIEVED TRUE ALTERNATIVE APPROACHES. WE RECOGNIZED EARLY IN DISCUSSIONS THAT ASSESSMENT OF RISK AND BENEFIT WAS ONE FACTOR TO BEER CANNED. THE RISK BENEFIT ANALYSIS PROVIDE DATA AND INFORMATION THE RISK BENEFIT ANALYSIS WOULD NOT MAKE POLICY DETERMINATION ABOUT GAIN OF FUNCTION STUDIES. SUCH DECISIONS ENTAIL WEIGHING RISK AND BENEFITS AND CONSIDERING DIFFERENT ETHICAL VALUES. AS I MENTIONED WE CONSULTED WITH A NUMBER OF ETHICISTS AND THE NIH COMMISSION PROFESSOR -- TO DRAFT A WHITE PAPER EXAMINING THE ETHICAL ISSUES THE PAPER IS DISCUSSED IN JANUARY AND AGAIN HIS REPORTS IS ON THE NSABB WEBSITE. IN THIS PAPER H ISOMERIZES THE ETHICAL LITERATURE AND POLICY WRITINGS ON GAIN OF FUNCTION RESEARCH. HE ALSO ANALYZED DIFFERENT ETHICAL AND DECISION MAKING FRAMEWORKS THAT COULD BE APPLIED WHEN MAKING DETERMINATIONS ABOUT FUNDING GAIN OF FUNCTION RESEARCH. FINALLY HE PROPOSED A PRINCIPLE BASED FORMAL FOR THE NSABB TO CONSIDER IN MAKING DECISIONS ABOUT WHAT OVERSIGHT TO RECOMMEND FOR GAIN OF FUNCTION RESEARCH. AGAIN, THE PAPER IS REALLY INTERESTING AND GENERATED A LOT OF IMPORTANT DISCUSSION THAT WAS VERY IMPORTANT TO OUR DELIBERATION. THE WORKING GROUP IMPROVED VALUES AT THE CORE OF ANY REVIEW AND DECISION MAKING PROCESS FOR GAIN OF FUNCTION RESEARCH. THESE VALUES ARE DESCRIBED IN DETAIL IN SECTION 4.2 OF DRAFT REPORT. THE SUBSTANTIVE VALUES ARE THOSE THAT SHOULD BE CONSIDERED WHEN DETERMINING WHETHER TO FUNDING GAIN OF FUNCTION PROPOSAL WHILE PROCEDURAL VALUES DEVELOPING A POLICY OR MECHANISM FOR REVIEWING GAIN OF FUNCTION PROPOSALS. WE TRIED TO INCORPORATE AND REFLECT THESE VALUES. THE WORK GROUP SPENT SIGNIFICANT TIME CONSIDERING CURRENT POLICY LANDSCAPE. PARTICULARLY AS IT RELATES TO GAIN OF FUNCTION STUDIES. WE RECEIVED BRIEFINGS FROM FEDERAL OFFICIALS ON LAWS POLICIES AND GUIDELINES. WE HEARD FROM INTERNATIONAL PARTNERS WHO HAVE CONSIDERING OVERSIGHT POLICIES FOR DUAL USE RESEARCH OF CONCERN. AS WELL AS GAIN OF FUNCTION STUDIES IN THEIR OWN COUNTRIES. WE STUDIED PUBLISHED GAIN OF FUNCTION STUDIES AND USED THESE AS GAYS STUDIES TO DISCUSS RISK AND BENEFIT AND TALK HOW DIFFERENT POLICIES PROVIDE TO REAL WORLD EXAMPLES. IT HELPED TO IDENTIFY STRENGTHS AND LIMITATIONS OF THE VARIOUS POLICIES. WE HAVE DESCRIBED OUR ANALYSIS OF THE RISKS, BENEFITS, ETHICS AND POLICY IN OUR DIRECT REPORT. WE HAVE ALSO TRIED TO FURTHER THIS PROCESS AND SUMMARIZE THE DIFFERENT STAKEHOLDER PERSPECTIVES THAT WE HAVE RECEIVED ALONG THE WAY. I WOULD LIKE TO FOCUS NOW ON SECTION 5 AND 6 OF THE REPORT WHICH DESCRIBE FINDINGS AND RECOMMENDATIONS. YOU RECALL IN JANUARY AT THE NSABB MEETING AND NATIONAL ACADEMIES MEETING WE DISCUSSED OUR DIRECT WORKING PAPER. WE HAVE BEEN MEETING SINCE THEN AND SIGNIFICANTLY REVISED THE REPORT BASED ON FEEDBACK FROM THE TWO MEETINGS. THE FINDINGS AND RECOMMENDATIONS IN PARTICULAR HAVE BEEN UPDATED. I WILL TRY TO POINT OUT THE AREAS THAT HAVE CHANGED SIGNIFICANTLY FROM THE PREVIOUS VERSION. WE TRIED TO DISTILL THINKING IN SEVENj FIRST FINDING, THERE ARE MANY TYPES OF GAIN OF FUNCTION STUDIES IN THAT ALL HAVE THE SAME LEVEL OF RISK. IT IS HERE WE CLAIM THAT TERM GAIN OF FUNCTION RESEARCH OF CONCERN. SMALL GAIN OF FUNCTION RESEARCH ENTAILS SIGNIFICANT RISK THAT WARRANT ADDITIONAL OVERSIGHT. OVER COURSE OF DELIBERATIONS WE HEARD MANY TIMES GAIN OF FUNCTION IS VERY BROAD TERM THAT CAPTURES MANY STUDIES WHICH ARE NOT PARTICULARLY CONCERNING, THE WORK GROUP SOUGHT TO IDENTIFY SUBSET OF GAIN OF FUNCTION STUDIES THAT ENTAIL THE MOST SIGNIFICANT AND UNIQUE RISKS. IN GENERAL THE WORKING GROUP CONSIDERS TO ENTAIL STUDIES THAT HAVE POTENTIAL TO GENERATE PATHOGENS WITH PANDEMIC POTENTIAL IN HUMANS. I'LL DESCRIBE WHAT WE MEAN BY THIS IN GREATER DETAIL A FEW SLIDES FROM NOW. FINDINGS TWO AND THREE ARE RELATED AND INVOLVE THE CURRENT POLICY LANDSCAPE. ACKNOWLEDGES THE US GOVERNMENT HAS POLICIES IN PLACE FOR MANAGING RISK ASSOCIATESSED WITH LIFE SCIENCES RESEARCH. THERE ARE SEVERAL PLANS THROUGHOUT THE RESEARCH LIFE CYCLE WHERE IF POLICIES ARE IMPLEMENTED EFFECTIVELY, RISKS CAN BE MANAGED AND OVERSIGHT GAIN OF FUNCTION RESEARCH OF CONCERN COULD BE IMPLEMENTED. HOWEVER ON FINDING THREE, WE NOTE THAT OVERSIGHT POLICIES VARY IN SCOPE AND APPLICABILITY. THIS MEANS THAT THE CURRENTS OVERSIGHT IS NOT SUFFICIENT FOR ALL GAIN OF FUNCTION RESEARCH THAT RAISES CONCERN. THIS FIGURE ILLUSTRATES HOW A NUMBER OF PATHOGENS ARE COVERED UNDER DIFFERENT POLICIES. FOR EXAMPLE WE SEE THAT AVIAN INFLUENZA H 5N 1 IS SUBJECT TO ALL POLICIES INCLUDING REVIEW OF GAPE OF FUNCTION STUDIES INVOLVED IN ENHANCED TRACE MISSIBILITY. RESEARCH INVOLVED IN OTHER INFLUENZA SUBJECT TO VARYING DEGREES OF OVERSIGHT. FOR MOST WITH DIFFERENCE PATHOGENS THE LEVEL OF OVERSIGHT IS APPROPRIATE AND DESIGNED TO BE COMMENSURATE WITH THE RISKS. HOWEVER THERE COULD BE GAIN OF FUNCTION RESEARCH OF CONCERN INVOLVING THESE OR OTHER PATHOGENS NOT SUBJECT TO SUFFICIENT OVERSIGHT. THE WORKING GROUPS FINDING ON PREVIOUS TWO NOTES THAT THE ADAPTIVE POLICY APPROACH IS DESIRABLE. ADAPTIVE APPROACH THAT INVOLVE COLLECTING INFORMATION AND EVALUATING THE POLICY OVER TIME TO ENSURE THAT OVERSIGHT IS COMMENSURATE WITH RISK. IT CAN ALSO HELP ENSURE BENEFITS OF RESEARCH ARE FULLY REALIZED. FINALLY FIVE ADDRESSES ISSUE THIS WORK GROUP SPENT A SIGNIFICANT AMOUNT OF TIME DISCUSSING. WHETHER THERE ARE GAIN OF FUNCTION STUDIES THAT SHOULDN'T BE ALLOWED. HERE WE KNOW THAT THERE ARE STUDIES THAT SHOULD NOT BE CONDUCTED BECAUSE THE POTENTIAL RISKS ARE NOT JUST DESIRED BY THE POTENTIAL BENEFITS. WE NOTE SOME SHOULD BE BASED ON CONSIDERATION OF RISK AND BENEFITS ASSOCIATESSED WITH SPECIFIC EXPERIMENTSES IN QUESTION. THIS INSLIDES CONSIDERATION OF SCIENTIFIC MERIT -- INCLUDES SCIENTIFIC MERIT BUT LEGAL ETHICAL PUBLIC HEALTH THAT ARE ALSO IMPORTANT AND NEED TO BE TAKEN INTO ACCOUNT. FINDINGS 6 AND 8 ARE FINDINGS THAT SPEAK TO CRITICAL ROLES AND STAKEHOLDERS AND LIFE SCIENCES THAT THE CRITICAL ROLE ALL STAKEHOLDERSES MUST PLAY TO ADDRESS SECURITY AND SAFETY ISSUES. AND NEED FOR CONFORMANCE WITH POLICIES. FINALLY ACKNOWLEDGING THE INTERNATIONAL NATURE OF GAIN OF FUNCTION ISSUE. WE NOTE HERE THE POTENTIAL RISKS AN BENEFITS ASSOCIATESSED WITH THAT ARE INTERNATIONAL IN NATURE, AND WE GO ON TO REFERENCE IMPORTANT WORK OUR PARTNERS ARE DOING TO GRAPPLE WITH DUAL USE AND GAIN OF FUNCTION ISSUES. SO THOSE FINDINGS IN MIND, THE WORKING GROUP DEVELOPED ITS DRAFT RECOMMENDATIONS. RECOMMENDATION ONE IS CENTRAL RECOMMENDATION. OUTLINE CONCEPTUAL APPROACH FOR IDENTIFICATION EVALUATION AN OVERSIGHT OF THE (INAUDIBLE) IT STATES RESEARCH PAROLES INVOLVED IN THAT ENTAIL SIGNIFICANT POTENTIAL RISK AND SHOULD RECEIVE ADDITIONAL MULTI-DISCIPLINARY REVIEW. PRIOR TO DETERMINING WHETHER THEY'RE ACCEPTABLE FOR FUNDING. SUCH PROJECTS SUBJECTS TO ONGOING OVERSIGHT AT FEDERAL AND INSTITUTIONAL LEVELS. PROPOTIONED OVERSIGHTS CAN BE THOUGHT OF IN THREE PARTS. FIRST THERE IS IDENTIFICATION OF GOFROC WE DESCRIBE AS RESEARCH GENERATING A PATHOGEN WITH TWO SPECIFIC ATTRIBUTES. NEXT THERE IS A FUNDING DECISION HERE WE HAVE DEVELOPED EIGHT PRINCIPLES TO HELP GUIDE THOSE FUNDING DECISIONS. AND THIRDLY THERE'S A PROCESS FOR PREFUNDING AND APPROVAL. FIRST IDENTIFY GOFROC. IN SHORT IT'S RESEARCH THAT CAN BE ANTICIPATE ANTICIPATED TO GENERATE PATHOGEN WITH PANDEMIC POTENTIAL. WE DEFINE MORE SPECIFICALLY AS RESEARCH THAT GENERATES PATHOGEN WITH FOLLOWING ATTRIBUTES. NUMBER ONE, THE PATHOGEN IS GENERATED IS LIKELY HIGHLY TRANSMISSIBLE AND LIKELY CAPABLE OF UNCONTROLLED SPREAD IN HUMAN POPULATIONS. AND NUMBER TWO, THE PATHOGEN WAS GENERATED LIKELY HIGHLY VIRULENT AND RECALL SIGNIFICANT MORE FIDDED BITY AND MORTALITY IN HUMANS. -- MORBIDITY AND MORTALITY IN HUMANS. BOTH ARE INTENDED TO INVOKE CONCEPT OF THRESHOLD, GENERATED PATHOGEN NEEDS TO BE EXPECTED TO BE HIGHLY VIRULENT AND TRANSMISSIBLE. TO BE CONSIDERED HIGHLY TRANSMISSIBLE THE PATHOGEN MUST BE JUDGED TO HAVE CAPACITY FOR SUSTAINED SECONDARY TRANSMISSION AMONG HUMANS, THIS IS INFLUENCED WHETHER HUMANS HAVE IMMUNITY TO THE PATHOGEN, OR PUBLIC HEALTH CONTROL MEASURES WOULD BE EXPECTED TO CONTAIN THE SPREAD OF THE PATHOGEN. TO BE CONSIDERED DUAL THE PATHOGEN MUST BE JUDGED CAPACITY FOR CAUSING SIGNIFICANT IN HUMANS SUCH AS SEVERE DISEASE, OR HIGH CASE FATALITY RATES. IMPORTANTLY THE PROPOSED EXPERIMENT DOES NOT NEED TO INVOLVE SIMULTANEOUS ENHANCEMENT OF PHENOTYPES TO BE CONSIDERED GOFROC. AS WE SAID A NUMBER OF TIMES, IT'S NOT WHAT WE START WITH BUT WHAT YOU END UP WITH. START WITH HIGHLY TRANSMISSIBLE PATHOGEN AND SIGNIFICANTLY ENHANCE VIRULENCE, THAT COULD BE GOFROC AND CONS VERSELY IF YOU START WITH A STARTING WITH TRANSMISSIBILITY IT TOO CAN BE GOFROC. WE REALIZE APPLYING THESE COULD BE SUBJECTIVE AND EXPERTS MA I DISAGREE WHAT CONSTITUTESES GOFROC. THE INTENTION IS THAT IT DESCRIBES STUDIES THAT GENERATE PATHOGENS WITH PANDEMIC POTENTIAL IN HUMANS. WE GENERATE SOMETHING THAT ARE HA SMALL SUBSET OF STUDIES RISE TO THIS LEVEL, APPENDIX WILL PROVIDE A FEW EXAMPLES THAT WOULD AND WOULD NOT CONSTITUTE GOFROC. OTHER STUDIES WE WOULDN'T EXPECT TO CONSTITUTE GOFROC IS CHARACTERIZATION OF CIRCULATING PATHOGENS SURVEILLANCE ACTIVITIES AND ACTIVITIES ASSOCIATED WITH DEVELOPING VACCINES. AFTER IDENTIFYING GOFROC THE TASK IS STUDYING WHETHER STUDIES SHOULD BE FUNDED THE WORKING GROUP ARTICULATED EIGHT PRINCIPALS TO GUIDE SUBSEQUENTS REVIEW AND FUNDING DECISIONS FOR PROPOSALS INVOLVING THAT. THE EXPECTATION IS THAT WE VIEW THAT IN ORDER TO BE FUNDED A PROPOSAL WOULD NEED TO BE IN LINE WITH ALL EIGHT PRINCIPLES. FIRST IS THE PROPOSAL HAS BEEN EVALUATED BY A PEER REVIEW PROCESS AND DETERMINED TO BE SCIENTIFICALLY MERITORIOUS. FIRST AND FOREMOST, THE STUDY MUST BE CONSIDERED GOOD SCIENCE. THE SECOND PRINCIPLES IS A NEW PRINCIPLE INTENDED TO COMPLIMENT THE FIRST. IT STATES THE PATHOGEN THAT ANTICIPATED TO BE GENERATED IS JUDGED BASED ON SCIENTIFIC EVIDENCE TO BE ABLE TO ARISE BY NATURAL PROCESSES. GOFROC IS PERMISSIBLE IF THE STUDY PROVIDES INSIGHT INTO NATIONAL -- NATURAL EVOLUTIONARY PROCESSES. ON THE OTHER HAND IT WOULD BE A LESS SCIENTIFIC VALUE AND MUCH MORE CONCERNING IF THE STUDY WERE ANTICIPATED TO GENERATE A LABORATORY PATHOGEN THAT IS IN -- UNLIKELY OR IMPOSSIBLE TO ARISE IN NATURE. THE THIRD PRINCIPLE SPEAKS TO THE IMPORTANCE OF WEARING POTENTIAL RISKS AND POTENTIAL BENEFITS OF THE PROPOSED RESEARCH. THE LIST SHOULD BE JUSTIFIED WHEN COMPARED WITH THE BENEFITS. THE THIRD PRINCIPLE REQUIRES THAT ALTERNATIVE APPROACHES BE EXPLICITSLY CONSIDER. IT IS IMPORTANT TO EXPLORE ALTERNATIVE WAYS TO ADDRESS THE SAME SCIENTIFIC QUESTION IN A MANNER THAT MAY POSE RISK WITH. THE INVESTIGATOR INSTITUTION PROPOSING THE RESEARCH HAVE DEMONSTRATED CAPACITY AND COMMITMENT TO CONDUCT RESEARCH SAFETY AND SECURITY. THIS IS IMPORTANT. THE INSTITUTION SHOULD HAVE FACILITIES AND STAFF TO SAVELY CONDUCT THE RESEARCH. THEY SHOULD ALSO HAVE THE ABILITY TO RESPOND RAPIDLY TO LABORATORY ACCIDENTS AND/OR SECURITY BREECHES. FROM THIS WILL INVOLVE THINGS LIKE INCIDENCE RESPONSE PLANS AND GOOD WORKING RELATIONSHIPS WITH LOCAL PUBLIC HEALTH OFFICIALS AND LAW ENFORCEMENT. PRINCIPLE SIX STATES THE RESULTS OF THE RESEARCH ARE ANTICIPATED TO BE BROADLY SHARED IN ORDER TO REALIZE ITS POTENTIAL BENEFITS TO GLOBAL HEALTH. THIS PRINCIPLE REQUIRES THAT PRIOR TO FUNDING GOFROC, CONSIDERATION WOULD BE GIVEN TO THE TYPE OF RESEARCH INFORMATION AND PRODUCTS THAT ARE LIKELY TO BE GENERATED. THE SEVEN PRINCIPLES THAT ALLOW FOR APPROPRIATE MANAGEMENT OF RISK THROUGHOUT THE COURSE OF THE PROJECTS. THIS MEANS THE FUNDING MECHANISMS USED FOR GOFROC ALLOW RISK MITIGATION MEASURES TO BE STIPULATED AT THE OUTSET AND IF NECESSARY, MODIFY DURING THE COURSE OF THE RESEARCH. THE PRINCIPLES THAT THE PROPOSED RESEARCH SHOULD BE ETHICALLY JUSTIFIABLE. WHILE NONE OF THE VALUES MENTIONED EARLIER ARE EMBODIED IN THESE GUIDING PRINCIPLES LISTED HERE, THE FOLLOWING PRINCIPLE EMPHASIZES BROADER ETHICAL VALUE SHOULD BE CONSIDERED WHEN REVIEWING PROPOSALS THAT INVOLVE GOFROC. THIS ILLUSTRATES THE WORKING GROUP PROPOSED REVIEW PROCESS. WE ENVISION BEING WITH INVESTIGATORS AN RESEARCH INSTITUTIONS IDENTIFYING POTENTIAL GOFROC IN PROPOSALS PRIOR TO SUBMISSION. RESEARCHERS SHOULD BE COGNIZANT OF RISK AND INSTITUTIONS SHOULD HAVE IN PLACE OR BE DEVELOPING RISK MITIGATION PLANS TO SAVELY CONDUCT THE WORK THEY ARE PROPOSING TO DO. IN STEP 2 FOLLOWING STANDARD SCIENTIFIC MERIT REVIEW PROCESS, FEDERAL FUNDING AGENCIES ARE RESPONSIBLE FOR IDENTIFYING OR CONCERNING THE PROPOSED GOFROC DEFINED BY TWO ATTRIBUTES DISCUSSED EARLIER. GOFROC PROPOSALS WOULD BE SUBJECT TO ADDITIONAL HIGHER DEPARTMENTS LEVEL REVIEW. OUR EIGHT PRINCIPLES SHOULD GUIDE THE REVIEWS, ONLY PROJECTS THAT ARE IN LINE WITH ALL EIGHT PRINCIPLES SHOULD BE CONSIDERED FOR ACCEPTABLE FOR FUNDING. FROM THE WORK GROUP EPIVISIONS THIS ADDITIONAL DEPARTMENT LEVEL REVIEW INVOLVES MULTI-DISCIPLINARY EXPERTISE, IT SHOULD -- WITH VARYING PERSPECTIVES INCLUDING SCIENTIFIC, PUBLIC HEALTH, BIOSAFETY, NATIONAL SECURITY, LEGAL, BIOETHICS AS WELL AS OTHERS. THIS REVIEW COULD ALSO IDENTIFY ADDITIONAL RISK MITIGATION MEASURES THAT MAYBE NECESSARY IN ORDER FOR THE PROJECTS TO BE FUNDED. IN STEP FOUR THE AGENCY WOULD MAKE A SUMMARY DECISION, IF FUNDED THE FUNDSER WOULD WORK WITH THE INSTITUTION TO ESTABLISH A SUITABLE RISK MANAGEMENT PLAN AND ISSUE THE FUNDING AWARDS WITH APPROPRIATE TERMS AND CONDITIONS TO ENSURE ONGOING OVERSIGHT. THE WORK GROUP IDENTIFY A NUMBER OF RISK MITIGATIONS THAT SHOULD BE CONSIDERED. THESE INCLUDE ENHANCING BIOSAFE I THE AND BIOSECURITY MEASURES, PROVIDING ADDITIONAL TRAINING TO RESEARCHERS, CONDUCTING MORE FREQUENT INSTITUTIONAL FEDERAL REVIEWS, IDENTIFYING CERTAIN TRIGGERS RE-EVALUATION OF THE RISK AND B BENEFITS, OR TREATING RESEARCH SUBJECTS TO THE US GOVERNMENT DUAL USE RESEARCH OF CONCERN POLICIES REGARDLESS OF THE PATHOGEN INVOLVED. >> WE PROOCCURS WITHIN THE DEPARTMENT OR AGENCY. HOWEVER, WORKING GROUP ALSO THOUGHT THAT IT WOULD BE VALUABLE TO HAVE EXTERNAL GROUP THAT INDEPENDENTSLY EVALUATE THIS PROCESS. WE ENVISION A FEDERAL ADVISORY COMMITTEE YOU WILL COULD EVALUATE THE GOVERNMENT'S REVIEW PROCESS FOR REVIEWING GOFROC AS ILLUSTRATED HERE. WE DO NOT ENVISION THIS COMMITTEE WOULD BE TASKED REVIEWING INDIVIDUAL RESEARCH PROPOSALS BUT COULD EVALUATE HOW THE PROCESS IS WORKING AND ITS RECOMMENDATIONS WOULD HELP ENSURE THE PROCESS REMAINS EFFECTIVE, EFFICIENT AND CAN ADAPT AS NEEDED. WE THOUGHT IT WAS SIGNIFICANT AND WARRANTED ITS OWN RECOMMENDATIONS. THIS PERIODIC EVALUATION IS ARTICULATED IN RECOMMENDATION TWO. THE PURPOSE OF THE EVALUATION IS TO PROVIDE INDEPENDENT EXAMINATION OF POLICIES FOR REVIEWING FUNDING AND CONDUCTING GOFROC. TO EXAMINE HOW DECISIONS ARE MADE, TO IDENTIFY CHALLENGES TO IMPLEMENTING THE POLICY. AND PROVIDE RECOMMENDATIONS AS NEEDED TO IMPROVE THE PROCESS. AN EXTERNAL ADVISORY COMMITTEE PROVIDES MORE TRANSPARENCY AND PROMOTE PUBLIC ENGAGEMENT WHICH IS VERY IMPORTANT. THE NEXT RECOMMENDATIONS ARE FAIRLY STRAIGHT FORWARD AND AIMED AT BROADER FUNCTION POLICY ISSUES. THE ADAPTIVE POLICY APPROACH ALREADY, AND IN RECOMMENDATION THREE WE EXPLICITSLY CALL FOR SUCH AN APPROACH. SINCE THE RISK BENEFIT RAND ESCAP CHANGES WE THINK IT'S IMPORTANT TO -- ADAPTIVE APPROACH REQUIRES POLICIES TO BE EVALUATED AND MODIFIED TO ENSURE THAT THE OVERSIGHT OF GOFROC IS COMMENCE RATES WITH RISK. -- COMMENSURATE WITH THE RISK. ALSO HELP ENSURE A POLICY NOTS UNNECESSARILY BURDEN SOME, THIS APPROACH WOULD ALLOW POLICY MAKERS TO LEARN FROM EXPERIENCE AND UPDATE POLICIES ACCORDINGLY. ADAPTIVE APPROACH WOULD ALSO BENEFIT GREATSLY FROM DATA. AND RECOMMENDATION 3.1 WE RECOMMEND THAT THE GOVERNMENT CONSIDER DEVELOPING A SYSTEM TO COLLECT DATA ABOUT LABORATORY SAFETY INCIDENTS. WE LEARNED FROM A RISK BENEFIT ANALYSIS THAT SUCH DATA WERE LACKING, HELP INFORM GAIN OF FUNCTION POLICY DEVELOPMENT OVER TIME. SHOULD BE INCORPORATED INTO EXISTING POLICY FRAMEWORKS WHEN POSSIBLE. THERE ARE A NUMBER OF POLICIES IN PLACE TO PROVIDE BIOSAFETY AND BIOSECURITY OVERSIGHT. IN OUR REPORT WE DESCRIBE SOME OF THE STRENGTHSES AND LIMITATIONS OF THE EXISTING POLICIES. IT WOULD BE PREFERABLE TO ADAPTS OR HARMONIZE CURRENTS POLICIES WHEREVER POSSIBLE OTHER THAN DEVELOPING POLICY SPECIFIC TO GOFROC. IF NSABB RECOMMENDATIONS ARE PRIMARILY MEANT TO INFORM EVALUATION OF FEDERALLY FUNDED GOFROC. HOWEVER, RECOMMENDATION 5 WE ENCOURAGE GOVERNMENTS TO CONSIDER WAYS TO ENSURE THAT GOFROC IS SUBJECT TO EQUIVALENTS OVERSIGHT REGARDLESS OF FUND SOURCE. THIS IS AN IMPORTANT RECOMMENDATION AND WORKING GROUP THINKS THIS NEEDS TO BE INCLUDED. RECOMMENDATION 6 AND 7 SPEAK TO NEEDS FOR CONTINUED ENGAGEMENTS IN DIALOGUE ON BIOSAFETY AND BIOSECURITY, PARTICULARLY AS THEY RELATE TO GOFROC. RECOMMENDATION 6 ENCOURAGES THE US GOVERNMENT TO UNDERTAKE BROAD EFFORTS TO STRENGTHEN LABORATORY BIOSAFETY AND BIOSECURITY. AS PARTS OF THESE HE WAS ITS WILL BE IMPORTANT TO RAISE AWARENESS ABOUT SPECIFIC ISSUES ASSOCIATED WITH GOFROC. OUTREACH INCLUDE ENGAGEMENT WITH RESEARCH COMMUNITY TO PROMOTE CULTURAL RESPONSIBILITIES OF SCIENTIFIC CITIZENSHIP. SAFETY SECURITIES AND PROMOTE PUBLIC TRUST IN THE SCIENTIFIC ENTERPRISE. FINALLY AS WE'RE AWARE LIFE SCIENCES RESEARCH IS A GLOBAL ENDEAVOR THAT CONTINUES TO GROW AS COUNTRIES INVEST IN RESEARCH CAPACITIES AND AS SCIENTISTS COLLABORATE ACROSS NATIONAL BORDERS. RECOMMENDATION 7 SPEAKS TO THE INTERNATIONAL NATURE OF RESEARCH, SPECIFICALLY TO THE RISKS, BENEFITS AND OTHER ASPECTS OF GOFROC WITH INTERNATIONAL DIMENSIONS. WE CALL ON THE US GOVERNMENT TO ENGAGE WITH THE INTERNATIONAL COMMUNITY REGARDING OVERSIGHT AND RESPONSIBLE CONDUCT OF RESEARCH ESPECIALLY FOR GOFROC. WITH THAT I THIGH FOR YOUR TIME AND ATTENTION, THANK YOU FOR YOUR TIME AND ATTENTION AND WORKING GROUP FOR THEIR HARD WORK, IT WAS AGAIN A REALLY GREAT PROCESS TO BE PART OF. I THINK ON THE AGENDA NEXT WE'LL HAVE TIME TO DISCUSS THIS IN MUCH GREATER DEPTH BUT IF THERE ARE ANY FOLLOW-UP QUESTIONS I WELCOME THEM AT THIS POINT. THANK YOU. QUESTIONS FOR JOE OR COMMITTEE, CLARIFICATIONS OR COMMENTS YOU WANT TO MAKE? AND AGAIN MANY OF YOU PARTS OF THE WORKING GROUP SO THIS DOCUMENT IS ONE YOU'RE IF I WILL MANY YARR WITH FOR OUR AUDIENCE TO RECOGNIZE THIS. OUR PREVIOUS PUBLIC MEETING. ANYBODY HAVE ANY COMMENCE THEY WANTS TO PA -- COMMENTS THEY WANTS TO MAKE AT THIS POINT IN TIME? PATS. >> FIRST THANKS JOE FOR THE WONDERFUL PRESENTATION AND THE WORKING GROUP FOR THE EXCELLENT REPORT. IN RECOMMENDATION 3 SUBSECTION 1 RECOMMENDATION 3.1 I SHOULD SAY IS IN ORDER TO HAVE ADAPTIVE APPROACH YOU'RE MAKING A STRONG RECOMMENDATION AROUND LABORATORY SAFETY INCIDENTS AND I WANTED TO BRING TO THE FRONTS WE RECEIVED INPUT FROM -- I FORGET PEOPLE'S NAMES, I WROTE SOME DOWN. DR. POTTSER FROM SAINT JUDE, RICH FROM DUKE UNIVERSITY, AS WELL AS CHALLENGES AROUND THE REVIEW ENTITY AND A NEW ENTITY AND CONVERGING TO COMMON SETS OF PARAMETERS. I WAS WONDERING IF IT WOULD BE USEFUL TO HAVE ADDITIONAL RECOMMENDATION WITHIN THREE SPECIFICALLY TARGETING HOW THE GOVERNMENT MIGHT SUPPORT THE COLLECTION OF DATA AROUND THE CHALLENGES DECISIONS AND LESSONS LEARNED BY THE INSTITUTIONAL REVIEW ENTITIES. >> THAT'S THE ESSENCE IS TO URGE THE GOVERNMENT TO PROVIDE A SYSTEM WHEREBY THESE INCIDENTS COULD BE REPORTED AND LESSONS LEARNED ABOUT THEM. >> I THINK WITH THE LEVEL OF UNCERTAINTY AND VARY -- LIKELY VARIABILITIES INSTITUTION TO INSTITUTION, I THINK IT MAYBE VALUABLE TO MAKE THAT EXPLICIT IN THE REPORTS. >> I THINK PATTED HAD SOME WORDING HE MAY SCHMITZ TO CHRIS WHICH COULD POTENTIALLY BE INSERTED. DOESN'T CHANGE THE MEANING OF ANYTHING BUT MAKES MORE SPECIFIC AND EXPANDS 3.1. >> VERY GOOD. THANK YOU. >> WE'RE NOTING THIS AND AS KEN SAID THERE MAY HAVE BEEN SOME WORDING THAT WAS EXTENT THAT WE CAN USELYZE HERE THAT MAY STRENGTHSEN THAT RECOMMENDATION. ANYBODY HAVE ANY COMMENTS ABOUT THAT PARTICULAR ISSUE? >> WHY DON'T WE READ THE COMMENTS IF YOU HAVE THEM? >> THE RECOMMENDATION I HAD FOR 3.2 WOULD BE THE US GOVERNMENT YOU CAN SEE A PARALLEL BETWEEN 3.2 I DRAFTED AND 3.1. US GOVERNMENT SHOULD CONSIDER DEVELOPING A SYSTEM TO COLLECT AND ANALYZE DATA ABOUT INSTITUTIONAL REVIEW AND ANY CHALLENGES DECISIONS AND LESSONS LEARNED TO PROVIDE FEEDBACK TO THE IRE COMMUNITY AND INFORM GAIN OF FUNCTION RESEARCH OF CONCERN POLICY DEVELOPMENT OVER TIME. EXAMINING DATA WOULD PROVIDE A BETTER UNDERSTANDING OF EFFECTIVENESS AND POLICY IMPLEMENTATION AND SUPPORT DECISION MAKING. >> COMMENTS ABOUT THAT? >> LET THE RECORD SHOW YOU HAVE JOINED US. >> I APOLOGIZE FOR MISSING THE BUS. I FOLLOW-UP TO THAT COMMENT I STATE IT'S NOTABLE TO ME THAT 3.1 IS ONE OF THE FEW PLACES WE USE THE WORLD SHOULD CONSIDER AS OPPOSED TO SHOULD. I'M WONDERING WHETHER WE SHOULD REMOVE THE WORD CONSIDER. I THINK IT'S SUCH AN IMPORTANT ISSUE TO LEARN FROM THE MISTAKES MADE. >> DO WE ARE ADVISORY SO WHETHER IT SHOULD OR SHOULDN'T CONSIDER, WE ARE ADVISORY, THE GOVERNMENT DOES NOT HAVE TO DO WHAT WE SAY SO I TAKE THAT. >> JUST CATCHING TO WHAT PAT IS TRYING TO COMMUNICATE. AND I WOULD SECOND THIS CONCEPT BECAUSE IT LOOKS LIKE BASICALLY YOU'RE CREATING A PARALLEL ON THE PROCESS AS DISTINCT FROM THE DATA ABOUT INCIDENTS ARE IN 3.1 NOW. 3.2 COMMUNICATE TO BE TRANSPARENT AND COMMUNICATE FOR EDUCATIONAL PURPOSES AND IMPROVEMENT OF PROCESSES. IS THAT THE GIST OF WHAT WE'RE TRYING -- >> >> I'M TRYING TO SHRINK THE LEARNING CYCLE TIME SO THAT IREs AREN'T BASICALLY TRACKING TWO YEARS DOWN THE ROAD ALL PUBLICATION, HERE IS A PEER OF MINE WHO PUBLISHED THIS TWO YEARS AFTER I SUBMITTED A COMPARABLE IDEA OR COMPARABLY, BY AD HOC INTERACTIONS THE THINGS ARE NOT BEING SUPPORTED, MAYBE YOUR INSTITUTION IS SERIOUSLY CONSIDERING AND GETTING THAT DIALOGUE GOING. >> ARE YOU TALKING INSTITUTIONAL ENTITY INVOLVED IN THIS GOFROC PROCESS? OR MORE BROADLY INVOLVED IN THE DERC PROCESS OR WHAT? >> I THINK IT APPLIES VERY BROADLY OBVIOUSLY THIS IS A RECOMMENDATION AROUND GAIN OF FUNCTION RESEARCH OF CONCERN BUT THE IREs AT MY INSTITUTION WE WOULD BENEFIT FROM HAVING SUBSTANTIALLY MORE INSIGHT INTO ALL THE OTHER IREs AND WHAT'S GOING ON, TRENDS AND AS THE TECHNOLOGIES AND THE SCIENCE BASES CHANGE, STAYS UP TO DATE AND NOT DISCOVERING ARE THAT THROUGH AD HOC NETWORKS. >> ARE YOU ENVISIONING INFORMATION SHARING OR ENVISIONING FEDERAL EVALUATION OF HOW COMMITTEES ARE OPERATING? >> I VIEW IT AS INFORMATION SHARING AND PARALLEL TO 3.1 WHERE IT'S A COLLECTION OF SAFETY DATA AND LESSONS LEARNED IN THE SAFETY REALM. THIS IS COLLECTION OF IRE PERFORMANCE AND PERSPECTIVE AND SHARING THAT INFORMATION. >> I THINK WE NEED TO BE CLEAR BECAUSE TO ME THOSE ARE SOMEWHAT DISTINCT FEDERAL ROLES. ONE IS TO CREATE A CLEARINGHOUSE SO THAT IREs CAN SEE WHAT EACH IS PRODUCING. THE OTHER IS DIFFERENT IN MY MIND, IT IS ACTUALLY EVOLVING STANDARDS IREs ARE HELD. WE DON'T DO THAT THOUGH MAYBE WE SHOULD FOR IRBs. >> WITH IRBs, IACUK AND IBC HISTORY IS MATURE NOW SO CHAIRS AND MEMBERS OF THE COMMITTEES HAVE A LOT MORE PRECEDENCE TO POINT TO AND SUPPORT OF THEIR DECISIONS. IN ADDITION TO SCIENTIFIC PERSPECTIVES AND I THINK WE'RE ABOUT TO ENTER A HUGE LEARNING CURVE FOR THE IR,Es, ANY INFORMATION PROVIDE AS FEEDBACK IS BENEFICIAL TO CONSISTENCY ACROSS THE U.S. PROGRAMS. I DON'T KNOW IF THERE IS A WAY TO TURN THE MIC OFF WHEN YOU'RE DONE. >> OTHER COMMENTS? >> THIS IS LOU ON THE PHONE. CAN YOU HEAR ME? >> WE CAN. >> >> SO I WANT TO ECHO WHAT SUSAN SAID. IT'S VERY IMPORTANT THAT THE LANGUAGE IS CLEAR AND (INDISCERNIBLE) ANYTHING WE CAN DO TO STRENGTHEN THE EDUCATION OF IREs (INAUDIBLE) >> SO THE POINT BEING THIS IS PRIMARILY AGAIN DATA EXCHANGE INFORMATION EXCHANGE WITH COORDINATION HOPEFULLY BY FEDERAL GOVERNMENT WITHOUT CREATING A NEW EVALUATION PROCESS OR STANDARD. IF WE CAN MAKE SURE THAT IS CONVEYED IN A RECOMMENDATION THAT THAT'S WHAT WE'RE PUTTING FORWARD THAT WOULD BE IMPORTANT. SUSAN, APPRECIATE THE DISTINCTION. OTHER QUESTIONS OR COMMENTS? >> THIS IS ONE OF MY FAVORITE GROUPS BECAUSE WE'RE AHEADS OF SCHEDULE WHICH IS ALWAYS VERY NICE. I'M GOING TO GO AHEAD AND START JOE. WE'LL START KEN, YOUR DISCUSSION PART AND IF PEOPLE GET HUNGRY WE'LL INTERRUPT TO TAKE A LUNCH BREAK AND BIOLOGICAL BREAK BUT WE CAN ALL GO FOR THAT. >> I'LL START FROM HERE. IF THAT DOESN'T WORK YOU'LL BE FACED WITH ME UP AT THE PODIUM. SO THANK YOU, SAM. WE HAVE OVER AN HOUR ON THE AGENDA TO TALK IN MORE DETAIL. WE HAVE ALREADY STARTED THIS DISCUSSION. THE LAST COUPLE OF MINUTES, ABOUT OUR REPORT. AND AFTER WE ARE DONE WITH THIS ROUND WE'LL HAVE PUBLIC COMMENT, THEN WE'LL HAVE ANOTHER SHOT SAYING WHAT WE THINK ABOUT WHAT WE HAVE HEARD. TO START WITH, I THINK IT WOULD BE GOOD TO HEAR FROM MEMBERS, PARTICULARLY THE NSABB ABOUT WHETHER THERE ARE ITEMS OR SPECIFIC ISSUES THAT SHOULD LIKE TO HAVE US DISCUSS IN THIS SESSION. I DON'T WANT TO GET INTO DISCUSSION RIGHT NOW BUT WE WANT TO MAKE A LISTING OF ANY ISSUES THAT PEOPLE THINK ARE IMPORTANT. WE'RE GOING TO GO THROUGH ALL THE RECOMMENDATIONS AND PRINCIPLES. BUT UP FRONT WE LIKE TO KNOW WHETHER THERE'S ANYTHING PARTICULARLY OF CONCERN TO ANY OF THE MEMBERS. >> FIRST LET ME START BY SAYING I FULLY SUPPORT THE REPORT AS IT'S BEEN DRAFTED, THIS IS A STEP FORWARD. AS WE HAVE ALL THE AGENCY REPRESENTATIVES HERE, I THINK IT WOULD BE NICE TO HAVE SOME SORT OF DISCUSSION ABOUT HOW WE WILL ACTUALLY OPERATIONALIZE THESE RECOMMENDATIONS, THERE'S SEVERAL LAYERS OF OVERSIGHT THAT ARE BEING PROPOSED. IT'S NOT CLEAR TO ME EXACTLY AT THE ENDS OF THE DAY WHO IS GOING TO BE DOING THAT WORK. >> I THINK AFTER WE HEAR EVERYTHING THAT WE'RE GOING TO HEAR, IT'S REALLY HOPED AND INTENDED THAT THE EX-OFFICIO MEMBERS MAY HAVE SPECIFIC COMMENTS OR MIGHT WELL ADDRESS WHAT YOU JUST SUGGESTED. WE'RE GOING TO START WITH ONE OF THE TOUGHEST, CERTAINLY FROM THE POINT OF VIEW OF THE WORKING GROUP, WE SPENT A LOT OF TIME ON RECOMMENDATION 1 WHERE WE DESCRIBE PROCESS FOR IDENTIFYING GAIN OF FUNCTION RESEARCH OF CONCERN. WE PUT FORWARD A PRE-FUNDING REVIEW PROCESS AND CALL FOR ONGOING FEDERAL AND INSTITUTIONAL OVERSIGHT. OUR INTENTION BEHIND THIS RECOMMENDATION WAS FOCUS ADDITIONAL OVERSIGHT ON RESEARCH THAT MIGHT GENERATE PATHOGENS WITH PANDEMIC POTENTIAL. THOSE ARE SMALL SUBSET THAT WE REFER TO AS GAIN OF FUNCTION RESEARCH OF CONCERN OR GOFROC SO WE MIGHT BEGIN DISCUSSING TWO ATTRIBUTES THAT THIS MOMENT WE THINK DEFINE GOFROC. THE FIRST IS THE PATHOGEN GENERATED IS HIGHLY TRANSMISSIBLE. AND LIKELY CAPABLE OF WIDE AND UNCONTROLLABLE SPREAD IN HUMAN POPULATIONS. SECONDLY, THE PATHOGEN IS HIGHLY VIRULENT AND LIKELY TO CAUSE SIGNIFICANT MORBIDITY AND MORTALITY IN HUMANS. THINKING BEHIND THESE ATTRIBUTES WAS IT'S NOT WHAT YOU START WITH, OR HOW YOU GET THERE, THE REAL ISSUE IS THE PATHOGEN YOU ENDS UP WITH. THAT MATTERS THE MOST. SO TO US ANY PROJECT THAT COULD BE ANTICIPATED TO GENERATE A PATHOGEN WITH BOTH ATTRIBUTES IS GAIN OF FUNCTION RESEARCH OF CONCERN. SETTLING THESE TWO ATTRIBUTES IS THE WORKING GROUP MOST DIFFICULT TASKS. AND I WOULD LIKE TO POINT OUT THAT THESE ATTRIBUTES WERE REFINED SIGNIFICANTLY AFTER SECOND NATIONAL ACADEMIES WORKSHOP. SO THIS POINT I WOULD LIKE TO OPEN FLOOR FOR DISCUSSION OF THESE TWO ATTRIBUTES WE'RE LOOKING FOR COMMENTS ABOUT DEFINITION OF GAIN OF FUNCTION RESEARCH. OF CONCERN. DOES IT CAPTURE AND EXCLUDE THE CORRECT STUDIES. ANY COMMENTS ON THIS QUESTION, ISSUE? MARCY, YOU LOOK LIKE YOU'RE -- >> IN READING A MAY 15 COMMENT FROM A MEMBER OF PUBLIC WHICH JUST SHOWS HOW PEOPLE READING THINGS SOMEHOW SEEK -- READ THINGS DIFFERENTLY, THAT COMMENT QUESTIONED HOW IT WOULD WORK WITH A STRAIN HIGHLY TRANSMISSIBLE BUT MODESTLY VIRULENT IN ANIMAL, IDENTIFYING ANIMAL. AND I THOUGHT WE WERE TALKING ABOUT AND HIGHLY VIRULENT IN HUMANS. WHETHER AS YOU ALWAYS SAY WHETHER DURING THE TIME OF THE RESEARCH OR WHAT WE LEARN FROM IT. >> I THINK WE'RE TALKING ABOUT THE END PRODUCT IN TERMS OF WHAT IT DOES TO PEOPLE. >> YES. Q. I THINK THE ISSUE THAT'S BEING RAISED TO A CERTAIN EXTENT IS HOW PREDICTIVE OUR ANIMAL -- ARE ANIMAL MODELS. THE MOUSE IS NOT A MAN OR WOMAN. AND SO YOU'RE NEVER SURE, ONE OF MY FAVORITE SAYINGS IS IF YOU CAN'T CURE CANCER IN A MOUSE YOU SHOULD HANG UP YOUR PIPETTE. WE HAVE DONE THAT LOTS OF TIMES, WE HAVE DONE QUITE SO SUCCESSFUL WITH PEOPLE. I THINK THAT THAT UNCERTAINTY IS IMPLICIT BUT I THINK THAT WE'RE STATING A PRINCIPLE HERE, IN OUR REPORT AND I THINK THE PRINCIPLE IN MY MIND IS THE CORRECT PRINCIPLE. SO THE VALIDITY OF THE QUESTION I THINK IS TRUE BUT I DON'T KNOW HOW IT REALLY IMPINGES UPON WHAT WE SAID. >> ISN'T THERE A COMMENT IN T BEGINNING INTRODUCTION OF THIS DOCUMENT TO SAY THAT RECOGNIZE THE IMPORTANCE OF TRANSMISSION IN ANIMALS BUT THAT THIS DOCUMENT ITSELF DEALS PRIMARILY WITH HUMAN ILLNESS I THINK WE ANTICIPATED THAT QUESTION. >> I THINK SO. BUT WE GOT IT ANYHOW. WE RESPONDED, AT LEAST I RESPONDED TO IT. >> THAT'S WHY I WANTED THE CONVERSATION. >> BUT POINT IS IT'S NOT AS IF THE WORKING GROUP DIDN'T CONSIDER THAT, THAT'S MY POINT. >> YOU'RE CORRECT. SUSAN. >> ACTUALLY, IF YOU LOOK AT LINE 1262 AND 1263, IT EXPLAINS TO BE CONSIDERED, QUOTE, HIGHLY VIR LEAPT, THE PATHOGEN ONE -- VIRULENT THE PATHOGEN SHOULD BE JUDGED FOR CAUSING SIGNIFICANT CONSEQUENCES IN HUMAN. SO WE DO ACTUALLY ADDRESS THIS. >> COULD YOU REMIND ME IF WE ARE FOCUSING ON HUMAN BECAUSE OF THE NARROWING OF SCOPE IN OUR CHARGE? OR DID WE PURPOSELY EXCLUDE IMPORTANT ESSENTIAL NON-HUMAN SYSTEMS CROPS ANIMALS? I THINK WE DECIDED TO FOCUS CHARGE TO HUMAN ISSUES SO WE CAN EVENTUALLY ACTUALLY COME UP WITH A REPORT. I THINK WHEN WE WERE TALKING ABOUT DUAL USE RESEARCH OF CONCERN, OBVIOUSLY WE'RE CONSIDERING A BROODER UNIVERSE THAN THE GENERAL SENSE. >> WE DID HAVE FOR THE RECORD THERE WAS A STRONG FEELING THAT THERE ARE ISSUES IN AGRICULTURE, FOOD SAFETY, ANIMAL SAFETY. BUT THERE WAS DISCUSSION GOING BACK TO CHARGE THAT WE AS A COMMITTEE RECEIVED. WE HAD TO MAKE CHOICES TO LIMIT SCOPE, NOT THAT THESE AREN'T IMPORTANT ISSUES. >> IT GOES TO THE CHARGE IN MY MIND. THE CHARGE WAS ABOUT OVERSIGHT OF RESEARCH GAIN OF FUNCTION WITH PANDEMIC POTENTIAL. HUMAN PUBLIC HEALTH. I'M IMPRESSED BY SHARPNESS OF THIS AND TO THE EXTENT IT PROVIDES A TEMPLATE FOR OTHER SITUATIONS WHETHER PATHOGENS OF OTHER SYSTEMS OR GENE DRIVES AN ENVIRONMENTS, THAT'S INTERESTING TO SEE HOW THAT WILL HOLD UP FOR NOW. >> OKAY. NEXT I THINK WE CAN DISCUSS THE EIGHT PRINCIPLES THAT SHOULD GUIDE FUNDING DECISIONS. OUR THINKING IS GOFROC CAN BE FUNDED BUT ONLY IF CONDUCTED IN ACCORDANCE WITH THE EIGHT PRINCIPLES. THE WORKING GROUP CONSIDER CERTAIN STUDIES THAT SHOULD BE BANNED OR OFF LIMITS. WE GENERALLY FELT THAT THESE STUDIES EXISTED BUT HAD A HARD TIME IDENTIFYING SPECIFIC STUDIES EXAMPLES SEEMED TO LACK SCIENTIFIC MERIT AND OF COURSE WE WOULDN'T WANT TO FUND SOMETHING THAT LACKED SCIENTIFIC MERIT UNDER ANY CONDITIONS. FROM DISEASE SO WE WENT TO PRINCIPLE BASED APPROACH THAT WE THINK WILL BE FLEXIBLE AND COULD BE APPLIED TO ANY RESEARCH THAT IS CONSIDERED GOFROC. JOE HAS ALREADY DESCRIBED THE EIGHT PRINCIPLES SO I WON'T GO THROUGH THEM AGAIN BUT I WOULD LIKE TO INVITE DISCUSSION ON THEM. AND IN PARTICULAR COMMENTS ABOUT PRINCIPLES THAT GUIDE FUNDING DECISIONS, FOR GAIN OF FUNCTION RESEARCH. OF CONCERN. SO WE HAVE THE EIGHT PRINCIPLES WHICH ARE LISTED SOMEWHERE. THEY DON'T ALL FIT ON ONE SLIDE. >> KEN IT'S LINE 1300 FOLLOWING IN THE DRAFT AS PEOPLE ARE GOING WHICH THAT. >> BEGINNING PAGE 45. >> SINCE THERE'S SEVERAL PRINCIPLES TO CONSIDER I'LL TAKE JUST A MOMENT HERE. LET PEOPLE TAKE A LOOK TO SEE IF ANYTHING CATCHES THEIR FANCY. >> FOR THOSE FOLLOWING ONLINE THESE ARE THINGS DISCUSSED IN DETAIL BY THE WORKING GROUP WHICH CONSTITUTES THE COMMITTEE SO IT SHOULDN'T BE SURPRISING IF THERE'S A UNANIMITY OR SEEM TO BE UNANIMITY OF SUITABILITY ON A NUMBER OF THESE RECOMMENDATIONS. >> WE'RE GOING DOWN IN ORDER HERE BUT FLEXIBILITY AND ADAPTABILITY IS MENTIONED, I THINK THIS DISCUSSION SHOULD ENCOMPASS THAT AS WELL. OKAY. THE FINAL SECTION OF RECOMMENDATION 1 DESCRIBES A PROPOSED OVERSIGHT PROCESS. A LOT OF DISCUSSION IN THE WORKING GROUP ABOUT THIS. SO SOMETIMES IT WAS A CONSENSUS, SOMETIMES TESTIFY A MAJORITY. BUT I DON'T THINK THERE WAS ANY STRONG RESISTANCE TO ANY OF THE FINAL DECISIONS. WE CALL FOR PRE-FUNDING REVIEW AND APPROVAL PROCESS FOR PROPOSALS CONTAINING GAIN OF FUNCTION RESEARCH OF CONCERN. I THINK KEY ISSUES INCLUDE THE FACT THAT THE FIRST LEVEL OF CONSIDERATION NEEDS TO BE AT THE LOCAL INSTITUTIONAL LEVEL. S FIRST BY THE INVESTIGATOR THEN BY THE IRE. THE NEXT LEVEL OF CONSIDERATION IS DURING THE CONSIDERATION OF SCIENTIFIC REVIEW BY REVIEW PANEL HOPEFULLY THEY'LL THINK WHETHER OR NOT THERE'S ISSUE. IF AN ISSUE IS IDENTIFIEDED BY THE FIRST THREE LAYERS THEN IT WOULD BE CONSIDERED AT DEPARTMENTAL LEVEL. IF THE DEPARTMENTAL LEVEL IS CONSIDERS THERE'S A BIG PROBLEM, IT CAN BE SUCH THAT THAT'S THE END OF IT. OR IT MIGHT BE CONSIDERED FOR MODIFICATION. AND IF IT'S CONSIDERED TO BE ACCEPTABLE THEN THEY CAN BE SENT BACK NOW THEY HAVE A SCIENTIFIC REVIEW, MERIT REVIEW AND THEY ALSO HAVE THE GOFROC DECISION. IF THEY'RE POSITIVE THERE CAN BE FUNDING RECOMMENDED. AT FINAL LEVEL THERE NEEDS TO BE ONGOING OVERSIGHT OF THE RESEARCH BOTH LOCAL INSTITUTIONAL LEVEL AND DEPARTMENTAL LEVEL. BECAUSE ONE OF THE BEAUTIES OF RERESEARCH IS IT'S HON -- IF IT'S HONEST THAT YOU DON'T KNOW WHAT THE ANSWER IS GOING TO BE BEFORE YOU DO THE EXPERIMENT. YOU NEVER KNOW WHAT MIGHT TURN UP THAT UNANTICIPATED, THOSE USUALLY THE BEST EXPERIMENTS. SO THAT IS WHERE WE ARE IN THIS SLIDE. THERE'S ANOTHER LAYER BUT THAT'S REALLY RECOMMENDATION 2. SO THIS WAS THE RECOMMENDATION OF THE WORKING GROUP FOR THE STRUCTURE OF REVIEW, AND REMEMBER THIS INTERDIGITATES WITH THE OTHER KINDS OF REVIEW RESEARCH FUNDED BY THE FEDERAL GOVERNMENT. BUT WE'RE CONSIDERING THIS BY ITSELF AT MOMENT. ARE THERE ANY COMMENTS >> STEP 3 ADDITIONAL DEPARTMENTAL REVIEW, IS THE ISSUE THAT I WAS TRYING TO THINK THROUGH HOW THIS WOULD BE DONE. SO I GUESS THE DEFAULT MODEL IS NIH AND THIS WOULD BE DONE AT HHS. BUT WE ALSO HAVE DEPARTMENTS OF DEFENSE AND HOMELAND SECURITY AND WHOLE BUNCH OF OTHER POTENTIAL FUNDERS, AT THE DEPARTMENTAL LEVEL. SO THE QUESTION FOR DISCUSSION, IS HOW DO WE ENSURE CONSISTENCY, HOW DO WE ENSURE THE REVIEW IS DONE BY PEOPLE THAT ARE EXPERTS SUFFICIENTLY BRIEFEDDED IN THE FIELD TO BE KNOWLEDGEABLE ABOUT THAT? >> I'M AFRAID TO RESPOND MYSELF TO THAT BECAUSE WE HAVE SEEN ISSUES ALONG THESE LINES MOW CAN I PHRASE IT, I GUESS THE PRINCIPLE ACCOUNTABILITY IS THE BEST PRINCIPLE TO BE THOUGHT ABOUT, DOESN'T NECESSARILY ALWAYS HAVE TO BE IDENTICAL BUT NEEDS TO BE MEANINGFUL AND FUNCTIONAL. AND WHEN WE ARE DONE GOING THROUGH COMMENTS FOR MEMBERS OF THE NSABB, THAT IS A KEY QUESTION. I THINK THAT AS AN ADVISORY COMMITTEE WE CAN'T TELL DEPARTMENTS HOW TO DO SOMETHING, WE CAN ONLY ADVISE STRONGLY THEY OUGHT TO DO SOMETHING. I DON'T WANT TO GET INTO TOO MANY DETAILS BUT LAST WEEK, OR WEEK BEFORE THERE'S A CONGRESSIONAL HEARING WHERE THERE WAS AN OUTSIDE GROUP THAT MADE RECOMMENDATIONS. COUPLE OF I AGENCIES WERE CHASTISED BY THE COMMITTEE BECAUSE WHAT THEY WERE DOING WASN'T CONSISTENT WITH THE RECOMMENDATIONS OF THE OUTSIDE WORKING GROUP. I BLAME IT ON JOE. BUT ANYWAY, THAT'S -- I THINK IT'S SAD THAT'S THE ISSUE THE DEPARTMENTS NEED TO BE COGNIZANT OF BECAUSE SOONER OR LATER IT BITES YOU. THAT'S ONE OF THE ARGUMENTS FOR PUTTING THINGS INTO THE PUBLIC. BECAUSE IT BECOMES ACCOUNTABILITY. >> ALONG THAT TA LINE MOVING TO THE NEXT RECOMMENDATION WE'RE CREATING POTENTIAL INTERFACE SHOULD THE GOVERNMENT CREATE THE PROCESS WE HAVE BEEN DESCRIBING. WE ARE AT SOME TIME FRAME FA CAYUSING HOLISTICALLY WHAT'S BEING DONE ACROSS THE DEPARTMENTS. IF WE HAVE THE OPPORTUNITY LATER TO LOOK AT THE EXOFFICIO MEMBERS, ITS WILL BE INTERESTING TO HEAR FROM THEM WHAT TYPE OF RELATIONSHIP WITH THAT PROPOSED FACA >> WHAT WE'RE HEARING IN THIS DISCUSSION IS WHAT WE WANTS TO HEAR. OF THE USG WHEN THEY GET THEIR CHANCE TO RESPOND. >> PAT. >> SO I THINK ANOTHER INTERPRETATION CONSISTENT WITH WHAT THE WORKING GROUP IS DOCUMENTED IS DEPARTMENT LEVEL REVIEW BECAUSE THERE ARE EXAMPLES OF OTHER TYPES OF REVIEW WHERE ONE DEPARTMENT IS REQUESTED BY ANOTHER TO PERFORM THE REVIEW BASED ON EXPERTISE AND IT HAPPENS IN ENERGY AND LIFE SCIENCES SO THERE ARE EXAMPLES WHERE ONE AGENCY IS HOST OF A REVIEW COMMITTEE WITH THE EXPERTS IN PLACE AND ANOTHER AGENCY CONSULTS THEM. THAT'S ANOTHER WAY TO IMPLEMENT WHAT YOU HAVE HERE >> THAT'S RATIONAL. I WANT TO EVENTUALLY HEAR THE RESPONSES. LET'S GO TO RECOMMENDATION 2 WHICH IS CLOSELY TIED IN AND ALLUDED TO THIS IS AN IMPORTANT ONE. WE HADN'T TALKED ABOUT IT EXCEPT TANGENTIALLY UNTIL WE HAD THE RECENT NATIONAL ACADEMIES MEETING. BUT BECAME APPARENT IT WAS PROBABLY IMPORTANT TO HAVE SOMETHING ALONG THESE LINES IN OUR REPORTS. SO IN RECOMMENDATION 2 WE RECOMMEND THAT EXTERNAL ADVISORY BODY EVALUATE OVERSIGHT POLICIES FOR GAIN OF FUNCTION RESEARCH OF CONCERN. WE ENVISION A FACA COMMITTEE, I DON'T KNOW WHAT SIMILAR GROUP THERE IS BUT A FACA COMMITTEE COULD EXAMINE U.S. POLICIES FOR GAIN OF FUNCTION RESEARCH OF CONCERN. IT COULD EXAMINE THE NEW REVIEW PROCESS, WE THINK A MECHANISM INCREASES TRANSPARENCY PROMOTE PUBLIC ENGAGEMENT, AND I THINK THOSE WHO ITEMS ARE KEY TO WHY WE MADE THIS RECOMMENDATION. AND FACILITATE CONTINUED DIALOGUE BUT ABOUT GOFROC, SO WHAT'S IMPORTANT TO SAY HERE, IS WHAT IS NOT RECOMMENDED, AT LEAST I SAID REVIEW OF SPECIFIC PROPOSALS, THAT'S NOT THE ISSUE. THE ISSUE IS TO TAKE A LOOK AT HOW THE PROCESS IS WORKING IN THE GOVERNMENT. SUSAN. >> I THINK THIS IS AN IMPORTANT RECOMMENDATION I WANT TO PROPOSE TWO LANGUAGE TWEAKSES FOR CLARITY. FOR OUR AUDIENCE. ONE IS THE WORD EXTERNAL. I AM CONCERNED IT COULD BE MISREAD AS MEANING OUTSIDE THE FEDERAL GOVERNMENT WHEN WE MEAN APPOINTED BY FEDERAL GOVERNMENT. NSABB IS ABOUT EXAMPLE OF A FACA COMMITTEE, WE'RE APPOINTED BY THE FEDERAL GOVERNMENT. WE ARE STAFFED BY FEDERAL GOVERNMENT WE HAVE IMPORTANT EX-OFFICIO MEMBERS WHEN I REREAD THE STATUTE TO SEE IF THE WORD EXTERNAL APPEARED DIDN'T. SO I THINK NOTHING IS LOST IN CLARITY MAYBE GAINED ON 1458, THE LINE WHICH BEGINS THE RECOMMENDATION BY SIMPLY SAYING AN ADVISORY BODY. I TOYED WITH INDEPENDENTS INSTEAD BUT HAS A FEW SAME PROBLEMS IT'S LITTLE BETTER SO THE WORD EXTERNAL WAS RECURS THROUGHOUT THE DOCUMENT AS THE MODIFIER, I WOULD STRIKE. AND IT ALSO OCCURS IN FIGURE 5 WHICH I THINK TURNED OUT GREAT BY THE WAY. >> SUSAN'S RECOMMENDATION THAT VERSION. >> I DIDN'T VOTE FOR THIS VERSION BUT IT TURNED OUT GREAT. THE OTHER TWEAK I SUGGEST WHICH YOU STUMBLED ON A SECOND AGO, IS IN LINE 1462. IN THE FIGURE WE SAY THIS ADVISORY COMMITTEE WE ENVISION IS A FACA COMMITTEE, THAT'S WHAT WE'RE TALKING ABOUT. HERE IN 1462 WE SAY SUCH AS A FACA COMMITTEE. I THINK WE NEED A FACA COMMITTEE. SO I WOULD SUGGEST REMOVING SUCH AS SO THE LINE 1462 BECOMES ADVISERY MECHANISMING YOU COMMITTEE GOVERNED BY FEDERAL ADVISERY COMMITTEE ACT. THOSE ARE MY TWO. >> I VIEW THAT AS A EDITORIAL TWEAK CHRIS WITH DEAL WITH. >> I'M TAKING NOTES ON SOME OF THE THING DISCUSSED AND I CAN RUN THROUGH THEM IN ANY -- IF YOU CHOOSE TO VOTES AT THE ENDS OF THIS, THIS CAN BE INCORPORATESSED AS A SUBSTANTIVE CHANGE. >> LETS ME POSE AN OBVIOUS QUESTION. TO ANYBODY LISTENING WOULD SAY NSABB THE LOGICAL BODY TO HEAR, IF NOT, WHY NO NOT? >> WE AVOIDED THAT FOR TWO REASONS, ONE WE DIDN'T WANT TO BE TOOTING OUR OWN HORN, IF YOU WILL. WE MIGHT HAVE WANTED TO BUT DIDN'T WANT TO APPEAR THAT WAY PUBLICLY. SECONDLY, I THINK THERE IS A GENERAL FEELING WE WANT TO GET MESSAGE TO THE GOVERNMENT AND LET THEM FIGURE HOW TO DO ITS. IF THEY WENT WITH NSABB THEY WOULDN'T HAVE TO CREATE ANOTHER FACA. BUT THAT'S THEIR ISSUE. SO WE DIDN'T WANTS TO PRESS TOO HARD. >> HAVING GONE THROUGH THIS A COUPLE OF TIMES BEFORE IN OTHER ON THIS COMMITTEE OR OTHER TOPICS, I GUESS I AGREE ENTIRELY THAT THE CONCEPTS OF EXTERNAL NEEDS TO BE CHANGED. AND IT WOULD SAY ADVISORY MECHANISM. I FORWARD CONTINUE TO FEEL UNCOMFORTABLE BECAUSE THERE IS A WHOLE WORLD OF THINKING ABOUT THE NUMBER OF COST OF HISTORY OF QUOTE EXISTING FEDERAL ADVISORY COMMITTEESES SO I THOUGHT WE CRAFTED A THOUGHTFUL WORD SUCH AS. IN OTHER WORDS I'M RECOMMENDING -- I AGREE THAT REVIEWING THE WORD, WHEREVER WE SAY EXTERNAL ADVISORY MECHANISM THAT WE SAY AN ADVISORY MECHANISM. I THINK WE'RE BUYING OURSELVES AS A COMMITTEE SOMETHING WE HAVE NOT STUDIED IN ENOUGH STEPS FOR ME TO SAY THERE IS ONLY ONE AND I'M CONCERNED THAT OTHERS WILL READ THIS. THAT THE OUTSIDE FIRST READER WILL SAY OH, THEY SAID ADVISORY COMMITTEE AND IF THE GOVERNMENT IN REVIEWING THIS HAS AN EQUALLY GOOD APPROACH, I WOULD PREFER THE US GOVERNMENT DECIDE HOW BEST TO DO IT AND IN WHICH CASE IT MAYBE A MECHANISM THAT I DON'T FEEL COMFORTABLE I KNOW ENOUGH ABOUT. SO I WOULD SAY SUCH AS COMMITTEE GOVERNED BY THE ACT. WOULD ALLOW FOR INDEPENDENT EXAMINATION. SO I'M NOT WED TO SAYING IT'S -- I THINK IT WILL BE OVERREAD JUST AS I'M READING COMMENTS THAT OVERREAD OTHER THINGS WE THOUGHT OH, IT SHOULD BE OBVIOUS THEY CAN TWEAK IT. >> LET ME RESPOND. THE STATUTE ITSELF COMMITS IF GOVERNMENT TO SCRUTINIZE FACA COMMITTEES AND BE CAREFUL AND SUN SET WHEN THEY'RE NO LONGER NEEDED AND BE PARSIMONIOUS IN THEIR CREATION AND MAINTENANCE. THAT'S BUILT INTO FACA ITSELF. THE REASON WE'RE RIGHT TO GRAVITATE TO FACA TO BE HONEST IS BECAUSE OF ITS COMMITMENT TO BRINGING IN THE PUBLIC TRANSPARENCY ON THE RECORDS. THIS IS THE LONG CON CONVERSATION ABOUT THE ROLE OF THE RAC AND EVOLVING CONVERSATION OVER TIME SO I THINK THAT BY ANCHORING IN THIS FACA WE WERE SAYING SOMETHING SUBSTANTIVE ABOUT NOT JUST HAVING SOME ENTITY THAT YOU WOULD PERIODICALLY LOOK AND SAY HOW WE'RE DOING BUT LOOK IN A WAY THAT THE PUBLIC COULD HAVE CONFIDENCE THEY WERE APPRISED OF, THEY COULD PARTICIPATE IN, AND WE ALSO SUGGEST THIS ENTITY HAVE CAPACITY TO SPONSOR PUBLIC DIALOGUE IF WARRANTED, THAT'S SORT OF ECHO OF THE RAC. SO THESE ARE FACA FUNCTIONS, THERE IS A MECHANISM. >> I'M NOT DISAGREEING, I WOULD SAY, AGAIN, I DON'T WANT TO DIGRESS OR BELABOR BUT THAT'S PRECISELY WHY WE PUT WORDS IN A SCRATCH STRIKE ADVISORY COMMITTEE DESIGNED FOR TRANSPARENCY AND PUBLIC ENGAGEMENT SHOULD BE UTILIZED PART OF THE GOVERNMENT ONGOING EVALUATION OF OVERSIGHT POLICIES FOR GOFROC. ADVISORY COMMITTEE SUCH AS A COMMITTEE P. SO I MADE MY POINT I FEEL WE ARE CONSTRAINING -- WE ARE CONSTRAINING THE ADVICE WE'RE GIVING, I DON'T FEEL -- I THINK WE CRAFTED A SHUTS L WIGGLE ROOM NOT KNOWING EXACTLY HOW THE NEXT TEN YEARS WILL WORK OUTS WHILE AGREEING WITH YOU THAT WE HAVE PUTS IN THEIR WORDS THAT CAPTURE THAT WE ARE SERIOUS ABOUT THIS BEING A TRANSPARENTS COMMITTEE THAT DOES INVOLVE PUBLIC ENGAGEMENT. BEYOND THAT, I DON'T FEEL COMFORTABLE WITH FOCUSING ON ONLY ONE APPROACH, EVEN IF THAT'S OOH THE APPROACH TAKEN, GREAT. THAT'S WHERE I DRAW THE LINE FOR MY COMFORT. >> I SUGGEST WE DIGEST ON THIS. SOONER OR LATER. WE COME BACK AND ASK FOR COMMENTS FROM END OF OUR DISCUSSION WEB PUSH THIS ISSUE FURTHER. >> I'LL GIVE EVERYBODY OVER LUNCH TO DO THAT. >> WE MAY GET ADVICE FROM OUR SEVERAL COLLEAGUES. >> IT'S A NON-ISSUE. >> IT'S GOOD TO HAVE THAT INPUT. I THINK IT'S PROBABLY GOD TO GET A SENSE OF THE REST OF THE COMMITTEE ON IT BECAUSE SO FAR WE HAVE BEEN UNANIMOUS ON MOST SO THERE'S -- AGAIN I THINK YOU'RE VERY CLOSE AND TWO LAWYERS. SO I WILL MARK IS THERE ANYBODY ELSE WHO HAS A COMMENT ON RECOMMENDATION 2? OTHER THAN THE ISSUE WE RAISED? >> LUNCH IS AT STAKE. >> WE GET TO EAT NO MATTER WHAT. ANY OTHER COMMENTS OR RECOMMENDATIONS? THEN WE'LL RETURN TO THIS AFTER LUNCH. WE'LL COME TO SOME TYPE OF CONCLUSION ON THIS. WE MAY ASK OUR EX-OFFICIO MEMBERS TO -- >> THIS WOULD ALLOW US TO BRING IN SOME OF THE THINGS THAT JIM WAS TALKING ABOUT AS WELL. SO WE'LL BRING THAT UP. >> I THINK WE CAN DEFER THIS LITTLE FURTHER IN DISCUSSION UNTIL WE GETS THROUGH THE OTHER STUFF. THEN COME BACK TO ITS. IF THERE ARE ANY OTHER ISSUES. >> TAKE UNDER ADVISEMENT. ANYBODY ELSE ANY OTHER COMMENTS? THEN WE'RE GOING TO BREAK AND WE'RE GOING TO REGROUP AT 12:35. THANK YOU. CONTINUE THROUGH THE RECOMMENDATIONS AND THEN WE GET THROUGH THE RECOMMENDATIONS WE WILL HAVE A CHANCE TO COMMENT. WILL ASK THE E OFFICIO MEMBERS TO COMMENT AND THE CHANGES IN WORDING WE TALKED ABOUT AND HOW EXOFFICIOS IN THE GOVERNMENT INTERPRET THE RECOMMENDATIONS SO I WOULD LOVE TO HEAR THEIR COMMENCE AS WELL. WITH THAT IN MIND, KEN, TAKE US TO RECOMMENDATION 3. >> WE WILL START WITH RECOMMENDATION 3, WHICH IS 2 NOW, POSSIBLY 3 DEPENDING HOW YOU COUNT RECOMMENDATIONS. THAT FOCUS ON IMPORTANCE OF ADAPTIVE POLICY RECOMBINANT DNA. ONE ADVANTAGE OF RECOMBINANT DNA GUIDELINES IS THEY WERE GUIDELINES AND THEY COULD BE AND COULD BE ADAPTED MODIFIED AS WE LEARN MORE. THAT'S ESSENTIALLY THE PROCESS WE'RE OR THE APPROACH WE'RE ADVOCATING. IN THIS RECOMMENDATION WE CALL FOR ADAPTIVE POLICY APPROACH TO HELP ENSURE THAT OVERSIGHT REMAINS COMMENSURATE WITH RISKS ASSOCIATED WITH GOFROC. TO INFORMED POLICY DEVELOPMENT, WE ALSO RECOMMEND THAT THE US GOVERNMENT CONSIDER DEVELOPING A SYSTEM TO COLLECT DATA ABOUT LABORATORY SAFETY INCIDENTS. THIS DATA WOULD PROVIDE A BETTER UNDERSTANDING AND ALLOW POLICIES TO BE REFINED OVER TIME. THAT'S 3.1. WE HEARD FROM PAT ABOUT HIS OATH THAT -- HOPE THAT THERE -- YOU CAN SAY SOMETHING LIGHTLY IN ADDITION AND HE OFFERED ADDITIONAL LANGUAGE, I WILL READ WHAT I HAVE HERE WHICH REFLECTS WHAT HE RECOMMENDED. THE US GOVERNMENT SHOULD CONSIDER DEVELOPING A SYSTEM TO COLLECT AND ANALYZE DATA ABOUT INSTITUTIONAL REVIEW ENTITY CHALLENGES. DECISIONS AND LESSONS LEARNED TO PROVIDE FEEDBACK TO THE IRE COMMUNITY AND INFORM GAIN OF FUNCTION RESEARCH CONCERN POLICY DEVELOPMENT OVER TIME. IN OTHER WORDS, SO WE'RE ALL ON LEVEL PLAYING FIELD VARIOUS INSTITUTIONS. WE WILL NEVER BE THE SAME LEVEL BECAUSE SOME PLACES ARE MORE INTO THIS THING, MORE SO FIST IT DAD AND IT'S CHALLENGING TO APPEAL TO A SINGLE INSTITUTION THAT YOU HAVE EVERYTHING YOU WOULD LUKE TO HAVE. BUT THE NOTION IS TO TRY AND LEVEL THE PLAYING FIELD AS MUCH AS POSSIBLE. EXAMINING DATA WILL PROVIDE EFFECTIVENESS AND CONSISTENCY OF POLICY IMPLEMENTATION AND SUPPORT LOCAL IRB DECISION MAKING SO LIKE PEOPLE TO BE INFORM AS POSSIBLE. GARY. >> I'M ALL FOR COMPRESSING IMPLEMENTATION OF THIS BUT WONDERING IF PROFESSIONAL SOCIETIES LINE MIGHT BE IN A BETTER POSITION SUCH AS, ABSA TO PROVIDE THAT CROSS FERTILIZATION OF INFORMATION AS OPPOSED TO BURDENNENING THE FEDERAL GOVERNMENT. >> MY PERSPECTIVE, IT CERTAINLY IS LEGITIMATE AND BE GREAT IF THAT HAPPENED BUT LIKE WE FIND OURSELF WANTING ADDITIONAL INFORMATION ABOUT LABORATORY ACCIDENT AND SAFETY SO I SEE A PARALLEL BETWEEN THE TWO. WITHOUT SOME FORCING FUNCTION AND FEDERAL GOVERNMENT CONSIDER SUPPORTING CONFERENCES AND OTHER THINGS IN THESE AREAS HOW IMPLEMENTED SHOULD LEVEL DISCRETION SO THREE YEARS FROM NOW NOT HAVE SIMILAR FEEDBACK AS WELL AS IRE THERE'S NO CONSISTENCY, WE NEED REGULATORY OVERSIGHT TO CREATE THAT AS PART OF THE PROCESS PROFESSIONAL SOCIETIES ARE A GREAT THING. >> ASN, APSA, ARE ALL WILLING ANXIOUS TO WEIGH IN ON AREAS NO REASON GOVERNMENT AS WELL COULD FACILITATE THIS KIND OF SPREAD OF INFORMATION. I THINK IN THE COMPETENCY AREA FOR CLINICAL TRIALS WE HAVE THE JIM CRIST SYSTEM WHICH IS USEFUL TO EVERYBODY ON THE OUTSIDE BECAUSE IT PUTS INTO PUBLICLY AVAILABLE SITE ALL THE SERIOUS ADVERSE EVENTS THAT OCCURRED IN CLINICAL TRIALS AND LETS LOCAL IRBs HAVE A BETTER INSIGHT INTO ISSUES THAT MIGHT ARISE. >> GREAT SUGGESTION BUT THERE NEEDS TO BE INFRASTRUCTURE FOR THIS REPORTING AND I DON'T KNOW HOW THE ASSOCIATIONS -- THIS ISN'T GOING TO COME WITHOUT INVESTMENT OF CAPITAL. I DON'T KNOW THOSE WOULD HAVE THE WHEREWITHAL TO DO THAT. >> I TAKE MORE FROM SOMETIME IT IS GOVERNMENT HAS DIFFICULTIES IN TAKING SUPPORT ENABLING ROLE VERSUS COMPLIANCE OVERSIGHT ROLE. THE IRBs COULD BE SOMEWHAT RELUCTANT TO SHARE ALL THEIR INSIGHT WITH THE GOVERNMENT ENTITY, BEING CONCERNED ABOUT GOVERNMENT OVERSIGHT RESPONSIBILITIES MAYBE PARTNERSHIP WOULD BE MORE SUPPORTIVE. >> I THINK WE CAN STATE WE HOPE THERE'S COMPLETE AND OPEN COMMUNICATION. BETWEEN LOCAL INSTITUTIONS AND GOVERNMENT ON THIS ISSUE. IF WE DETECT THERE SUSPECT FOR WHATEVER REASON WE HAVE A MAJOR ISSUE THAT WILL ARISE. SO I UNDERSTAND THE DEPENDENCY YOU SUGGEST BUT I THINK WE SHALL DISCOURAGE TO WHATEVER EXTENT WE CAN AND ENCOURAGE COMPLETE OPEN DISCUSSION IN THIS AREA PERSONALLY. OTHER COMMENTS? I DON'T KNOW HOW WE HANDLE THIS ONE. BEFORE WE MOVE ON IT WOULD BE NICE TO KNOW SOME GENERAL SUPPORT FOR PAT'S SUGGESTED LANGUAGE TO INVOKE THIS IDEA THAT WE WE SUGGEST THE GOVERNMENT COLLECT DATA ABOUT HOW IREs ARE FUNCTIONING. SPECIFIC LANGUAGE PAT SUGGESTED IS THE GOVERNMENT SHOULD CONSIDER DEVELOPING A SYSTEM TO COLLECT AND ANALYZE DATA ABOUT IRE CHALLENGES DECISIONS AND LESSONS LEARNED TO PROVIDE FEEDBACK TO THE IRE COMMUNITY AN INFORM GAIN OF FUNCTION RESEARCH OVER CONCERNED POLICY DEVELOPMENT OVER TIME. ARE THERE OBJECTIONS TO THAT, IF NOT, WE CAN PROPOSE THAT LATER IN THE MEETING AS LANGUAGE THAT CAN BE INCORPORATED. >> JUST SAY YES OR NO. LET ME CONTEMPLATE FURTHER. >> IF IT SAID CONSIDER DEVELOPING -- >> FACILITATING IS FINE. JUST TRYING TO ENVISION -- >> GETS IN THE WAY FROM SAYING AS A GOVERNMENT THING. >> MUCH IS WITH THE GOVERNMENT AND -- TRYING TO ENVISION HOW THE GOVERNMENT WOULD DO THAT. MAYBE GOVERNMENT IS READY TO SPEAK. >> IS THERE ANYBODY WHO HAS ANY DIFFICULTY WITH ADDING THIS STATEMENT TO THE REPORT? >> WITH MODIFICATION I JUST MADE. >> THINGS LIKE THIS WERE DONE IN THE PAST WITH THE DIRK EVOLUTION THAT TOOK PLACE THROUGH PUBLIC INFORMATION SHARING, NOT EXACTLY WHAT YOU TALK ABOUT BUT RELATES TO IT. INFORMS THE SAME ISSUE. LESS THAN A YEAR AGO THERE WAS SYMPOSIUM ON THIS CAMPUS THAT INVOLVED INSTITUTIONAL OFFICIALS SHARING EXPERIENCES ABOUT DUAL USE RESEARCH OF CONCERN. ONCE OR TWICE DURING EARLY STAGE DERK PAMS WERE RUN OPEN TO THE PUBLIC AND WEBCAST WITH INSTITUTIONAL OFFICIAL SHARING HOW THEY DID DERK EVALUATION SO THAT ACCOMPLISHED THE SAME THING SO WORDS THAT DON'T MAKE IT TOO SPECIFIC HAPPENS AND WHEN WE GET FED AL SIDE I'LL WALK THROUGH DIRK BECAUSE IT WILL PREVIEW WHAT WE MIGHT EXPECT TO SEE WITH GOF BECAUSE ALL THE SAME ELEMENTS ARE THERE. SO THERE ARE PROBABLY THREE PUBLIC PANELS POPULATED WITH PEOPLE FROM VARIOUS SECTORS OF THE GOVERNMENT, THE RESEARCHER, CHAIR OF VARIOUS PARABLE AND OFFICIALS SHARING LEARNEDDED WITH THE COMMUNITY. >> WHAT YOU HEARD FROM FAULT IS THE IDEA -- I WOULD LIKE TO GET -- FROM PAT, THE COMMITTEE FEELS IT'S WORTHWHILE TO FORMALIZE THE RECOMMENDATION TO SEE WE WOULD LIKE TO SEE JUST WHAT YOU WERE DESCRIBING HAPPENING FOR THIS AS WELL. DATA COLLECTION E EXCHANGE GOING ON NOT RELATED TO COMPLIANCE FUNCTION IS A CONCERN SOMEHOW. PEOPLE HAVE AN OBJECTION? WE CAN DISCUSS IT. EVERYBODY SHOULD FEEL COMFORTABLE? SO UNANIMOUS SENSE OF THE COMMITTEE THAT I HAVE, JOE DID YOU WANT TO ADD SOMETHING? >> >> ADDING GARY'S COMMENT ABOUT THE DIRECT ROLE OF I WONDER IF IT SHOULD BE USED IN 3.1. SAYS HERE CONSIDER DEVELOPING A SYSTEM FACILITATE DEVELOPMENT OF SYSTEM? >> I LIKE TO WORD FACILITATE FOR 3.2, I LIKE IT A LOT, CATALYZE FACILITATE, STIMULATE, AS FAR AS 3-POINT # IS CONCERNED, WE HAVE HISTORY OF COLLECTING OCCUPATIONAL SAFETY HEALTH DATA. THEY ARE QUITE DIFFERENT. >> IF THAT'S THE CASE, JOE. >> I WAS GOING TO ADD'S CONSISTENT WITH THE THINKING OF THE REPORT. RECALL EVERYONE DECIDED HOW IMPORTANT IT WAS BEFOREHAND FOR RECOMMENDING NIH DEVELOP POINTS TO CONSIDER IN YOUR PROPOSAL TOGETHER HAVING RETROSPECTIVE AFTERWARDS IS SOMETHING THAT CAME TO MIND >> GO AHEAD, KEN. >> I WONDER IF WE CAN GET A COPY SOMEBODY TYPE UP THE STATEMENT AND PASS IT SO WE CAN READ IT. >> WE WILL DO THAT. >> RECOMMENDATION FOUR. >> THANK YOU. WHERE AM I HERE. THERE ARE MODELS FOR DEPARTMENT LEVEL PREFUNDING REVIEWS AND DIRC especially. THIS REPORT WE POINT OUT GAPS AND LIMITATIONS IN THOSE POLICIES BUT IN GENERAL WE THINK EXISTING POLICIES PROVIDE A GOOD START POINT. FOR OVERSIGHT IN GOFROC. THIS RECOMMENDATION ALSO SPEAKS TO THE IMPORTANCE OF HARMONIZING EXISTING POLICIES. WHICH I'M REALLY INTERESTED IN HEARING FROM EX-O FISH GROW MEMBERS BECAUSE GOD KNOWS HOW MANY DIFFERENT REVIEW MECHANISMS A PROPOSAL MIGHT HAVE TO GO THROUGH UNDER CERTAIN CONDITIONS ACCOMPLISHING THE SAME THING OVER AGAIN, PROBABLY NOT ABOUT EFFICIENT PROCESS SO THAT'S A KEY ISSUE. SO THIS THIS SIMPLY SAYS THAT THERE SHOULD BE HARMONIZATION TO THE EXTENT POSSIBLE. THE NEXT ONE I THINK IS MUCH MORE IMPORTANT THAN POSITION AND THE LIST IMPLIES. WHAT IT SAYS IS IF YOU'RE GOING TO REGULATE GAIN OF FUNCTION RESEARCH OF CONCERN, AT LEAST IN THE UNITED STATES, THERE'S NO REASON TO SAY SOME OF THIS SHOULD BE REGULATED AND SOME OF IT SHOULDN'T BE REGULATED DEPENDING UPON WHO IS FUNDING IT. THOUGH THE CHARGE DON'T PRIMARILY GUIDING U.S. FUNDING DECISIONS, WE THINK THAT ALL GOFROC SHOULD BE CONSIDERED. WE RECOMMEND THE GOVERNMENT LOOK INTO WAYS TO MAKE ALL GAIN OF FUNCTION RESEARCH OF CONCERN SUBJECT TO EQUIVALENT OVERSIGHT. THAT WILL BE TO HEAR AGAIN FROM EX-OFFICIO MEMBERS HOW THEY THINK THAT MIGHT BE ACHIEVED. FAIR TO SAY WORKING GROUP ALWAYS THOUGHT ABOUT THIS PARTICULAR ISSUE IT'S SOMETHING THAT CAME INTO FOCUS AFTER THE LAST NATIONAL ACADEMIES WORKSHOP. IS THERE ANYBODY THAT DOESN'T THINK THIS SORT OF RESEARCH SHOULDN'T BE REGULATED IN THE SAME MANNER? >> I WOULD QUALIFY AN EXPRESENTATION REGULATED IN THE SAME MANNER. BECAUSE I THINK THE AUDIENCE FOR EXAMPLE U.S. COMPANIES WILL READ THAT KIND OF LANGUAGE FOR WHAT IT IS. I THINK THIS IS ONE OF THE MORE BOLD AND FAR-REACHING RECOMMENDATIONS WE MADE, AGREE WITH YOU COMPLETELY WHEREVER IT'S NUMBERED IS GOING TO BE DISCUSSED A LOT AND A GREAT STEP FORWARD EVEN TO SUGGEST PRIVATE SECTOR INSTITUTIONS THAT DON'T RECEIVE GOVERNMENT FUNDING WHICH WAS BY THE TERMS OF OUR CHARGE WHAT WE WERE ASKED TO LOOK AT AND WE PUSHED THAT SO I JUST BE CAUTIOUS IN WHAT WE MEAN AND NOT USE SO MUCH -- EXACTLY THE SAME OR WHATEVER, FOR EXAMPLE WE SET UP A REVIEW MECHANISM WITHIN AN AGENCY WITHIN THE DEPARTMENT SO WE CAN GET THE SAME GOAL WITHOUT NECESSARILY THE SAME PROCESS. >> EQUIVALENT. >> LET ME POINT OUT SOMETHING ELSE THAT SAID THIS RECOMMENDATION WE ALREADY KNOW IF THE NIH FOR INSTANCE FUNDS RESEARCH IN A FOREIGN INSTITUTION IT HAS TO MEET SAME PARAMETERS IF YOU WILL, AS RESEARCH CONDUCTED IN IN THE UNITED STATES. WHAT THIS RECOMMENDS IS THAT IF A U.S. COMPANY DECIDES TO DO THIS KIND OF RESEARCH AT A ATTORNEY SITE, THAT IT ALSO SHOULD FACE EQUIVALENT OVERSIGHT. THAT CAN BE A MAJOR IMPLICATION. SO I WOULD BE INTERESTED, MAYBE I'M MISINTERPRETING BUT I THINK THAT'S WHAT IT SAYS. SO I THINK THAT I WOULD BE INTERESTED IN COMMENTS ABOUT THIS ASPECT. DID IT COP CERTAIN ANYBODY? NOBODY IS CONCERNED. JOE MAYBE YOU'RE CONCERNED. >> FROM IT'S A GENERAL COMMENT YOU'RE MAKING AND RESULT MANY LIT THE DEVIL IS IN THE DETAIL. TO BE CONTINUED, TO BE DETERMINED YOU'RE LAYING OUT THERE THROWING A GRENADE AND WALKING AWAY. >> I WANT TO BE AWARE WHAT POTENTIAL IMPLICATIONS ARE OF WHAT IT IS THAT WE'RE RECOMMENDING. IF WE HAD OUR WAY, IT WOULD BE TRUE INTERNATIONALLY AS WELL AND THAT COMES UP LATER. HOW WE APPROACH THAT NOTION. BUT THIS IS MORE FOCUSED >> THERE CEASES TO BE UNANIMITY IN THE WORKING GROUP DISCUSSING THIS AND REALIZING EVEN CROWD FUNDING OF VARIOUS THINGS THAT CAN HAPPEN THAT NOT GOING TO HAVE MUCH IMPACT UNLESS YOU BROADEN IT AND HOW THAT'S BROADENED NEEDS TO BE DETERMINED. BUT I DON'T KNOW HOW YOU CAN MAKE IT ANY MORE GENERIC THAN IT IS IN WITHDRAWING IT TO MY MIND WOULDN'T BE GOOD AT ALL. >> ALL RIGHT. WE HAVE -- >> I APPRECIATE IT VERY MUCH IN CONTEXT OF GOFROC BUT I WORRY ABOUT CONSEQUENCE OF SUCCESS. WHERE IN THE GOVERNMENT FIGURES A WAY TO DO THIS USING GOFROC AS THE TEMPLATE. BUT LATER IN DIFFERENT CONTEXT REDEPLOY THE NEW CAPACITY. SO UNINTENDED CONSEQUENCE OF GETTING IT RIGHT FOR THIS. I THINK WE HAVE EXAMPLES OF BEHAVIOR FROM THE PRIVATE SECTOR TO VOLUNTARILY COMPLY WITH NIH STANDARDS THOUGH THEY RECEIVE NO FUNDING AND THAT'S FAIRLY WIDELY HEALTH PERSPECTIVE OF FOR PROFIT NON-PROFIT COMPANIES IN THE UNITED STATES AND IF THAT'S THE INTENT IN THE WORLD HERE AS I STUDY SUPPORT THAT MODEL, AS LONG AS EQUIVALENCY IS ACCEPTABLE VERSUS MAKING IDENTICAL. INTELLECTUAL PROPERTY AND OTHER ISSUES, OTHER PROCESSES IN PLACE SO AS LONG AS IT IS CONSISTENT WITH THIS YOU GET VOLUNTARY BEHAVIOR YOU'RE LOOK FOR. >> AS WE TALKED ABOUT BEFORE FOR LIABILITY PURPOSES THERE'S EXTRAORDINARY PRESSURE ON COMPANIES TO COMPLY, THIS IS CONSISTENT WITH THE BELIEF OF THE BODY THAT THERE IS A THING GAIN OF FUNCTION RESEARCH OF CONCERN. IF IT'S NOT GOOD FOR LABORATORIES REGULATED, INSTITUTIONS BY THE FEDERAL GOVERNMENT DOING IN MANY WAYS PROBABLY NOT GOOD FOR OTHER TOTS DO IT WITHOUT ADEQUATE CONCERN FOR DISEASE. I'M COMFORTABLE WITH THIS. Q. I REMIND EVERYONE ONE WAY IS THROUGH REGULATION, IT'S NOT WHAT WE INTEND HERE THE LANGUAGE IS WELL WRITTEN FOR THAT REASON. BUT IS STILL A NAGGING CONCERN OF MINE. WOULD SOMEONE REMIND ME AS WE LOOK AT WHAT IS HAPPENING IN EUROPE WHERE SOME COUNTRIES IN SOME AREAS, WASN'T THE WORK BEING DONE BROADLY SPONSORED BY GOVERNMENT FUNDS THERE WERE SOME COUNTRIES THAT ALREADY PROVIDE GUIDELINES FOR PEOPLE DOING RESEARCH OF THIS TYPE REGARDLESS OF -- >> >> I THOUGHT EE WAS RESEARCH. >> THAT'S MY POINT. >> INTERESTED TO HEAR THE STATE DEPARTMENT ABOUT THIS ISSUE. >> DETAILS VARY COUNTRY TO COUNTRY BUT CERTAINLY A LOT OF COUNTRIES, MOST WORK WOULD BE REGULATED UNDER THEIR STRUCTURES WHETHER OR NOT IT'S FUNDED BY THE STATE. THE LINK TO FUNDING IS ALMOST UNIQUE TO THE UNITED STATES AND ESSENTIALLY DONE HERE BECAUSE OF A LACK OF LEGAL AND REGULATORY AUTHORITIES AS A WORK-AROUND. >> ALL RIGHT. >> IT REMAINS AN INCREDIBLY IMPORTANT RECOMMENDATION AND WOULD BE NICE IF IN SPIRIT IF IT BECAME TRUE. >> RECOMMENDATION CALLS FOR GREATER OUTREACH IN RECOMMENDATION FOR BIOSAFETY AND BIOSECURITY. WE WOULD LIKE TO SEE THE DISCUSSION OF GOFROC AS PART OF THESE EFFORTS. WE NOTE IN THIS RECOMMENDATION THAT NEW RULES AND POLICIES ALONE WILL NOT BE ENOUGH IS TO ENSURE RESPONSIBLE GAIN OF FUNCTION RESEARCH OF CONCERN, BOTTOM UP APPROACHES WOULD BE ESSENTIAL, JIM LEDUC IS ONE WHO EMPHASIZED THE NOTION OF CITIZENSHIP ON THE PART OF EVERYBODY ENGAGED IN THE PROCESS. SO BOTTOM UP APPROACHES ARE ESSENTIAL TO PROMOTE A CULTURE OF RESPONSIBILITY. CAN IDEA THROUGH EDUCATION AND TRAINING OF BIOSAFETY AND BIOSECURITY, WE CAN PROMOTE A SHARED SENSE OF RESPONSIBILITY AMONG ALL PARTICIPANTS IN THE RESEARCH ENTERPRISE. WE WOULD LIKE TO SEE MORE OF THESE EFFORTS. ANYONE TAKE EXCEPTION TO THIS NOBLE NOTION? >> I WON'T TAKE EXCEPTION BUT IN THIS RECOMMENDATION IT SPEAKS TO THE IMPORTANCE OF PROFESSIONAL SOCIETIES I WONDER IF THAT GETS AT THE COMMENTS YOU MADE EARLIER ABOUT A PREVIOUS RECOMMENDATION, IMPORTANCE OF BOTTOM UP APPROACHES IN PROFESSIONAL SOCIETIES AND SHARING BEST PRACTICES. WANT TO PUT IT OUT THERE IT'S SPOKEN TO IN THIS RECOMMENDATION, I DON'T KNOW IF IT SATISFIES YOU. >> I APPRECIATE THAT. >> IT WILL TAKE A COMMUNITY OF STAKEHOLDER GROUPS IN EACH ONE CAN CONTRIBUTE BASED ON CONSTRAINTS THAT I ENJOY. OR DON'T ENJOY, THE GOVERNMENT HAS POWERFUL ABILITY TO BRING TO BEAR BUT THEY ALSO HAVE CHALLENGES WHERE THE PRIVATE SECTOR HAS ABILITY DIFFERENT TYPES OF CHALLENGES. >> I THINK THE SOCIETIES ARE GOOD TO CERTAIN DEGREES MORE OR LESS HIGHLY ORGANIZED, ASM VERSUS HIGHLY ORGANIZED IN THIS TYPE OF ACTIVITY AND CAN PURSUE IT. I THINK THOUGH, THAT ONE OF THE ISSUES IS THAT IF THE GOVERNMENT IS GOING TO HAVE REGULATION IF YOU WILL, AT LEAST OF NIH OR OTHER GOVERNMENT FUNDED RESEARCH , AND IT IS UNDER SOME OBLIGATION TO PROVIDE FOR INSTANCE ONLINE EDUCATIONAL OPPORTUNITIES IN THIS AREA, ALREADY DONE IN TERMS OF DERC, I THINK THAT WAS VERY HELPFUL ACTIVITY. A LOT DONE IN COORDINATION WITH THE NSABB. I THINK THAT THE SAME THING IS ANTICIPATED HERE. SO BOTH SIDES SHOULD BE CONTRIBUTORY. NUMBER 7. OUR FINAL RECOMMENDATION SPEAKS TO THE IMPORTANCE OF INTERNATIONAL ENGAGEMENT, THIS IS A TOPIC THE WORKING GROUP FELT IMPORTANT FROM THE BEGINNING BUT THIS SPECIFIC RECOMMENDATION IS A NEW ONE. HERE WE CALL THE US GOVERNMENT TO ENGAGE THE INTERNATIONAL COMMUNITY IN DIALOGUE ABOUT GAIN OF FUNCTION OF RESEARCH OF CONCERN. THE NSABB AND THE US GOVERNMENT HAVE A HISTORY OF INTERNATIONAL ENGAGEMENT BUT THE GAIN OF FUNCTION ISSUE WARRANTS A NEW COMMITMENT TO THESE EFFORTS. THERE'S A LOT OF DISCUSSION OF INTERNATIONAL ISSUES AT THE SECOND NATIONAL ACADEMIES WORKSHOP GIVEN RECENT EFFORTS OF THE U.S. AND THE EUROPEAN NATIONAL ACADEMIES OF SCIENCE. IT SEEMS THE TWO BODIES ARE WELL SUITED TO BRING SCIENTISTS AND POLICY MAKERS TOGETHER ON THIS ISSUE AS WELL. LET ME JUST APPEND THAT LAST SENTENCE. THIS WAS BROUGHT UP SPEAKING TO MULLEN AT THE ACADEMIES SYMPOSIUM AND VOLKER PLAYS A MAJOR ROLE IN NATIONAL ACADEMIES, AS SENIOR FIGURE. AND WHAT HE WAS SUGGESTING WAS THIS COULD BE A STEP WISE PROCESS YOU CAN START WITH TWO PLAYERS, EUROPEAN UNION AND U.S., AND IF A CONSENSUS TERMS OF APPROACH COULD BE ACHIEVED, IT COULD KEEP BEING EXTENDED TO MORE PLAYERS AND WE ALL KNOW THERE ARE MAJOR PLAYERS IN ASIA WHO ARE INVOLVED IN THIS, CERTAINLY CHINESE, ARE ACTIVE, JAPANESE AND ASIA THEY'RE DOING WORK THE NOTION IS YOU BRING EVERYBODY TOGETHER, YOU WIND UP WITH A WHO AND IT'S HARD TO ACHIEVE. MEANINGFUL CONSENSUS BUT GOING STEP BY STEP YOU MIGHT BE MORE EFFECTIVE. THIS RECOMMENDATION SHOWS INTERNATIONAL COOPERATION AND WE SHOULD GET STARTED ON IT. SO I WILL THROW IT OUT FOR DISCUSSION WITH THOSE CONSIDERATIONS. >> THANK YOU ALL FOR YOUR -- THE FIRST STEP HAS BEEN ACHIEVED AND NOW ON TO THE REST OF THE WORLD SOT I THINK WE'RE AT A POINT WHERE AT THIS POINT I THINK WE REALLY WANT TO HEAR FROM THE EX-OFFICIOS AND THEIR RESPONSE TO WHAT THEY HEARD SO FAR. WE WOULD BE PARTICULARLY INTERESTED IN THIS REPORT HOW IT'S RECEIVED AND IMPLEMENTED BY THEIR DEPARTMENT AND IF WE GET THAT WE'LL BE DOING WELL. >> I AGREE. >> MANY YOU'RE IN CHARGE. >> NO IT WOULD BE GREAT TO HEAR FROM THE EX-OFFICIO MEMBERS AND I WILL DO THE CAVEAT I RECOGNIZE THAT IT MAYBE PREMATURE FOR YOU TO SPEAK IN SOME WAYS HOW THIS MIGHT BE IMPLEMENTED THERE'S OTHER PEOPLE TO TALK TO WITHIN YOUR AGENCY AND SO ON. BUT WE WOULD BE INTERESTED IN GENERAL IN YOUR VIEW ON THE RECOMMENDATIONS, WE HAD A LITTLE INTEREST AROUND WORDING SUCH AS VERSUS IN TERMS OF THE WHAT KIND OF COMMITTEE, ADVISORY COMMITTEE LOOKING AT DEPARTMENTAL PROCESS WE SUGGESTED, IS THERE A FEELING FROM YOU OR NOT PARTICULARLY MATERIAL THAT WE'RE SUGGESTING SPECIFICALLY THE MECHANISM USED TO CREATE NSABB OR SOMETHING DIFFERENT, DOES THAT MATTER? WE'RE CURIOUS ABOUT THAT. IN GENERAL ON RECOMMENDATIONS ARE THERE THINGS YOU FIND TROUBLESOME IN TERMS OF WAY THAT MIGHT CREATE A BARRIER TO THE IMPLEMENTATION OF SOME OF THE RECOMMENDATIONS WE HAVE DONE. DENNIS DO YOU WANT TO START? WE HAVE THE EXPERIENCE WITH DERK. >> I'LL START WITH MY VISION OF THE PAST, IT'S EASIER THAN THE FUTURE AND LET OTHERS SPEAK TO THE FUTURE. FROM TTZ SO IN TERMS OF ADVISORY COMMITTEE WE CAN FEEL BRILLIANT ABOUT IT, THAT THAT'S A GOOD WIN WIN. WE HAVE LEARNED QUITE A LOT WHEN WE WENT THROUGH DUAL USE RESEARCH AND DUAL USE RESEARCH OF CONCERN. I DON'T SEE SIGNIFICANT DIFFERENCES PROCEDURALLY BETWEEN THE TWO. SO GIVE PEOPLE CONFIDENCE WE HAVE DONE IT BEFORE WE CAN PROBABLY DO IT AGAIN. LET'S WALK THROUGH THE KEY STEPPINGS THERE WERE. SO WE HAD TO DEFINE WHAT IT IS, WHAT IS DUAL USE, WHAT IS DUAL USE RESEARCH OF CONCERN. AND WE HAD TO FIGURE WHO LOOKS FOR IT. WE STARTED WITH GOVERNMENT AND SHIFTED WHERE COMMUNITY LOOKS TOO, IT'S BETTER BOTH LOOKING AT THE SAME TIME COME FROM BOTH DIRECTIONS AND HOW TO IDENTIFY IT, THAT REQUIRES HOW DO YOU KNOW HOW TO DO THIS. DUAL USE RESEARCH OF CONCERN WITHIN THE GOVERNMENT IS THERE WAS CORE OF EXPERTISE THOSE CONNECTED TO NSABB AND LIKE LARRY TABAK SAID AT THE BEGINNING I HAVE BEEN HERE SINCE 2004 MEETING HOWEVER I FEEL LIKE IT'S A LIFE SENTENCE. SO WE HAD RELEVANT STAFF ORGANIZE TRAINING OF TRAINERS, AND WORK THROUGH DEFINITIONS OF DUAL USE RESEARCH WERE, IDENTIFY WHAT VARIOUS STEPS WERE IN THE PROCESS, WEPT BACK TO WORK GROUPS AND TRAINED THE OTHER STAFF RESPONSIBLE FOR FUNDING PROJECTS THESE THINGS ARE LIKELY TO OCCUR. AND THERE'S CONSISTENCY IN DECISIONS BEING MADE AND COMMITTEE TYPE DECISION WHERE WE CAME TOGETHER AND TALKED THROUGH CASES, WITH VARIOUS PROGRAMS, AND WE STRUGGLED IS IT OR ISN'T IT, WE HAD GROUP DISCUSSIONS AND EDUCATED PEOPLE WHEN THEY HAD SIMILAR THINGS COME UP IN THEIR GROUPS. TO POINT OUT WHAT KEN SAID, NOT IMPORTANT TO GET THE SAME WAY EVERYWHERE, NSABB POINTED OUT COMING THROUGH THE DRAFT DOCUMENTS THAT PRECEDED THIS, THE IMPORTANT THING IS HAVING CONVERSATION, GOING THROUGH DISCUSSION, TRYING TO DO THE RIGHT THING. SO THAT EXERCISE, BECAUSE WE COULDN'T GET 100% AGREEMENT ON THE DIRK EXAMPLES WHEN WE HAD BETA TESTING. WE HAD A REALLY CONCERNED US AT FIRST SO WE RECOGNIZE WE'RE LOOKING AT MITIGATING THINGS IN THE PROCESS. WE MITIGATED THINGS WHETHER THEY WERE OR WERE NOT IN A PARTICULAR CATEGORY. SO THAT GETS INFORMATION FILTERED ACROSS AND SHARED ACROSS THE INSTITUTION. AS I MENTIONED THERE WERE PANEL DISCUSSIONS THAT THE ROLL OUT OF DUAL USE RESEARCH OF CONCERN AT THE FEDERAL LEVEL, ALSO PROFESSIONAL SOCIETIES AT THE BEGINNING OR HAVING PANELS ON THIS, THERE WAS SYMPOSIUM AT A. CXFCSM, A SYMPOSIUM AT BIO. AT THE NEW PLEATING PEOPLE WENT THROUGH THE GOVERNMENT SIDE WHAT THESE ARE, THERE WAS PUBLIC DISCUSSION, THERE'S KNOWLEDGE MADE ITS WAY TO BEHAVIOR AND CULTURE. WE AT THE GOVERNMENT LEVEL ANNUALLY TRACK THINGS WE FOUND ON DUAL USE RESEARCH OF CONCERN LIST, TRANSFEDERAL TELEPHONE CONFERENCES WHERE AGENCIES GET TOGETHER AND WE HAVE TO LISTEN TO WHAT DUAL USE RESEARCH OF CONCERN IS, THE STEPS WE GO THROUGH, IS IT IN SCOPE, EXPERIMENT OF CONCERN AND DO THEY GENERATE POTENTIAL TO X Y Z, THAT'S A TRAINING PROCESS WE HEAR FROM THE SAME TIME FROM A CENTRALIZED PROCESS SO ELEMENT OF CENTRALIZATION BRINGING EVERYBODY TO HARMONY, DOES THAT P HAPPEN SAME WAY EVERY AGENCY EXPERIENCE GOING THROUGH INVENTORIES. SO THAT GIVES YOU A LITTLE HISTORY ON HOW WE HAD THE BRAND NEW THING, WE HAD TO LEARN THROUGH IT IN TERMS OF DEFINITIONS PANNED FINDING WHO THE PEOPLE WERE NEEDING TO BE INVOLVED. WE ADJUSTED ALONG THE WAY, SHARED THAT PUBLICLY. AT SPONSORED PANELS AND ALSO PARTICIPATED IN THE DUAL EXCHANGE OF INFORMATION WITH SOCIETIES AT ANNUAL MEETINGS AND QUITE A BIT FUNDING STAFF ENTERTAIN CONVERSATIONS ALL THE TIME WITH THEIR CONSTITUENCY GROUPS. SO LIKELY CANDIDATES HERE FOR ENCOUNTERING THIS? ON THE ORDER OF INCIDENTS YOU WILL FIND AT NIH IN THE THICK OF HAVING A LOT OF WORK GOING ON AT NIAID. MANY PEOPLE THAT SIDE OF THE ROOM IN TERMS OF GAIN OF FUNCTION ASPECT ALSO CDC, AND TO SOME EXTENT DOD. AS POSSIBILITY OF ENTERING THIS WORK, AND FDA YOU HAVE TO THINK ABOUT THEM TOO BECAUSE IT'S NOT WHAT YOU START WITH IT'S WHAT YOU WIND UP WITH AND GENERATE SOMETHING THAT COULD BE MEETING CRITERIA. SO THOSE DUAL USE RESEARCH OF CONCERN IN THE CORPORATE WISDOM TO CARRY FORWARD. DOESN'T ANSWER ANY SPECIFIC QUESTION BUT SHOWS YOU ANALOGY, HOW THIS MIGHT UNFOLDED SINCE WE CAN'T TELL YOU HOW IT'S UNFOLDING ANYWAY IN TERMS OF GAIN OF FUNCTION. >> DR. -- IS GO HAS ALREADY SAID WHAT I'M GOING TO SAY. NOT BOUND TO THE PROCESS NOT WE'RE GOING TO DO AND WHEN SO THAT'S SOMETHING WE WILL CHUG THROUGH, I ARE GO OUTSIDE THE TALKING POINTS AND LET YOU IN ON A SECRET THAT AGENCIES DON'T ALWAYS AGREE. WE MAY HAVE INTERNAL DISCUSSIONS ON ALL THESE POINTS. NOT SPECIFICS OF RECOMMENDING BUT GENERAL OBSERVATIONS, IN TERMS OF I DO APPRECIATE THAT THE GROUP HAS SAID IN BUN CASE HERE IS THE OBJECTIVE WE WON'T TELL THE GOVERNMENT HOW TO DO IT, NOT BECAUSE IT'S NOT YOUR BUSINESS BUT IT IS IMPORTANT TO GET THAT VISION AND DON'T GET BOGGED DOWN,'S IMPORTANT THE SEE WHERE YOU HEADED, IN THAT CASE, IF YOU STARTED SAYING DO THIS, DO THAT, MAYBE THAT WOULD BE THE RIGHT WAY. THE ADVANTAGE OF THAT IN SOME CASES THERE'S A FEASIBILITY AND VISION, IF YOU KNOW HOW THE GOVERNMENT WOULD DO IT, MAKES MORE LIKELY TO FINE IT THEMSELVES BUT IT'S IMPORTANT TO RESTRICT -- DON'T RESTRICT YOURSELF TO THAT. IT'S IMPORTANT TO SAY HERE IS WHERE WE WANT TO GO. YOU CAN FIGURE IT OUT. FACA, NOT TAKING POSITION ONE WAY OR THE OTHER BUT I DO WANT TO REMIND YOU THE OBVIOUS, THIS IS NOT A BINDING DOCUMENT, SO WE LOOK AT RECOMMENDATION AND IF IT SAYS FACA OR SUCH AS FACA, SUCH AS FACA OKAY WE HAVE -- IT'S FACA WE GO OKAY, WE STILL THINK IT'S DIFFERENT BUT LET'S UNDERSTAND WHY THEY SAID THAT SO IT CHANGES OUR THINKING. BUT IT'S NOT -- WE'RE NOT TAKING THIS THIS AS A TAKE IT OR LEAVE IT PROPOSITION. ONE OTHER THING IS THIS, GIVEN A COMPREHENSIVE SET OF RECOMMENDATIONS ON RANGE OF THING, YOU WANT TO BREAK IT DOWN HOW MOVEK PARTS WORK ON THE INSIDE I SEE FOUR TYPES OF THINGS YOU'RE DOING WHICH ARE INCREASING LEVEL OF DIFFICULTY. CERTAIN THINGS IN THE GOVERNMENT DIFFERENTLY. IF WE SHOULD AGREE WE CAN DO THAT. WE CAN DO THINGS DIFFERENTLY. THEN THERE'S THINGS FEDERAL GOVERNMENT SHOULD CREATE STRUCTURES, THAT'S HARDER TAKE SOME BUDGET MAYBE TAKE AUTHORITY, THAT MIGHT BE MORE DIFFICULT TO IMPLEMENT IN PLACE. THEN FEDERAL GOVERNMENT MONEY WHAT TO DO, YOU'RE REACHING OUTSIDE THE FEDERAL GOVERNMENT AND DEALING WITH THE WORLD AT LARGE AND THERE'S A BUNCH OF OTHER FEATURES THAT COME IN, NOT COMMITTING TO THE PROCESS, IF THE FAST ISSUE GUIDANCE AFFECTING THE COMMUNITY, THAT HAS TO GO THROUGH FEDERAL REGISTER PROCESS, AND NOT COMMITTING TO THAT, NOT SURE HOW THAT FITS BUT THAT'S TYPICALLY WHAT HAPPENS, THERE'S TIME LINES THERE. FINALLY BECAUSE YOU TOOK OUR ADVICE SETTING THE GOAL YOU'RE SAYING THE FEDERAL GOVERNMENT SHOULD DIRECT PEOPLE THAT DON'T NECESSARILY TAKE FEDERAL MONEY. I'M NOT A LAWYER BUT SURE THAT TAKES A STATUTE. MAYBE A NEW STATUTE POSSIBLY EXISTING BUT THAT IS A DIFFERENT ORDER OF RECOMMENDATION. WE APPRECIATE YOU SETTING A CLEAR VISION AND IT'S INCUMBENT TO RESPOND TO THATTER OR DECIDE THAT'S NOT THE WAY WE WANT TO GO BUT THAT'S HELPFUL. THOUGH WE HAVE A STAIRCASE LIGHT TO HEAVY WRAPPED UP IN THIS PACKAGE. WHAT I CAN COMMIT TO IS GETTING SOMETHING DONE IN A PERIOD OF TIME TO MOVE ON. HOW HIGH UP THE LADDER WE GO, I CAN'T PROMISE. >> VERY MUCH APPRECIATED. OTHER MENS OF OUR -- YES. EX-OFFICIO MEMBERS TO COMMENT. >> I THINK CDC IS IN A GOOD POSITION THE WAY THIS HAS COME OUT BECAUSE I THINK YOU RECOGNIZE THERE'S CERTAIN TYPES OF PUBLIC HEALTH RESEARCH THAT HAVE LEGITIMATE USES AND IF DONE CORRECTLY CAN BE CONTINUED. CDC ISN'T IN THE SAME POSITION AS NIH, WE DON'T FUND BASIC RESEARCH, THISK TERM FUNDING -- THIS EXTERNAL FUNDING IS FOR CAPACITY BUILDING, LABORATORY STRENGTHENING, VACCINES, THAT SORT OF THING. THE INTERNAL RESEARCH I THINK LIKE NIH WE HAVE REVIEW PROCESS FOR DUAL USE RESEARCH SET UP, WE HAVE A MECHANISM FOR LOOKING AT DIRK. WE HAVE INSTITUTIONAL REVIEW ENTITY TO LOOK AT THIS RESEARCH AND HAVE HAD THAT SINCE WE SET UP AD HOC WHEN THE 1918 INFLUENZA WAS CONCERNED. IN THAT REGARD BASIC PROPOSALS ARE WHAT WE WOULD HAVE WANTED AND EXPECTED. THERE'S SOME THINGS THAT ARE NOT IN PLACE NOW, AND YOU NEED TO THINK HOW THEY ARE PUT IN PLACE. THE ONE THAT CATCHES MY EYE PRIMARILY HOW THIS LISTING OF SAFETY INCIDENCE AND HOW IT'S WORDED, SAFES SAFETY I'M SORRY DENSE I ASSUME YOU'RE GOING TO CATCH NEAR MISSES TO LOOK AT TRENDS, WHO IS GOING TO DO THAT? DURING THE EARLIER MEETINGS IT BECAME APPARENT THAT THERE WAS NO CENTRAL CLEARINGHOUSE THAT COLLECTED THAT INFORMATION. THE CLOSE EST WE HAVE WAS SELECT AGENT PROGRAM. THAT'S ONLY FOR SPECIFIC AGENTS. I NOTICE WHEN YOU PUT THOSE RECOMMENDATIONS TOGETHER YOU ARE ADMIRABLY PATHOGEN AGNOSTIC. YOU DIDN'T LIMIT YOURSELF TO FLU SARS AND MERS. THAT RAISES THE QUESTION OF WHETHER YOU EXPECT THIS TO BE APPLIED TO RESEARCH WITH ANY PATHOGEN. THAT IS ULTIMATELY A GOOD IDEA BECAUSE YOU DON'T KNOW WHAT HAPPENINGS DURING EXPERIMENTS, IT WOULDN'T HAVE TO BE JUST ONE OF THOSE THREE THAT CAUSES PROBLEMS. THOSE ARE SOME THINGS TO THINK ABOUT. WE ARE PLEASEDDED WITH THE WAY DELIBERATIONS ARE IS COME OUT. KEEPING TRACK OF SAFETY INCIDENTS, I THINK EVERYBODY KNOWS THAT'S COMING. YOU HAVE TO FIGURE HOW TO DO IT. THIS IS GOING TO BE ANOTHER FAIRLY SENIOR EXPECTED ADVISORY COMMITTEE, I THINK THAT WILL EM H. >> OTHER COMMENTS FROM EX OFFICIOS. >> JUST A COUPLE. FIRST I WANT TO CONGRATULATE THE COMMITTEE, THE WORKING GROUP I THINK THIS CAME OUT BROADLY SPEAKING ABOUT RIGHT, THERE ARE ALWAYS THINGS TO QUIBBLE WITH AND AS WE GO THROUGH THE NEXT STAGE FIGURING HOW TO IMPLEMENT, A LOT OF THAT QUIBBLING WILL HAPPEN. BUT WHAT I THINK IS INTERESTING IS THE WAY RECOMMENDATIONS CREATE AN OVERARCHING STRUCTURE. THERE'S A BASIC ELEMENT, DEFINED WHAT IT IS WE'RE TRYING TO CAPTURE. AND A SET OF PRINCIPLES OR CRITERIA FOR FUNDING AND IMPLEMENTING, THAT IS FAIRLY ACTIONABLE. WE HAVE TO DO WORK EXACTLY HOW BUT IT'S PRETTY STRAIGHT FORWARD. YOU THEN THOUGHT IN THE NEXT COUPLE OF RECOMMENDATIONS ABOUT ALL RIGHT, HOW DOES THIS EVOLVE OVER TIME? WHICH IS IMPORTANT BECAUSE THERE'S A TENDENCY IN GOVERNMENT TO SAY WE'RE DONE. USUALLY AT THE POINT OF STARTING THE IMPLEMENTATION PHASE SO YOU TALK ADAPTIVE APPROACHES, YOU TALK CREATION OF SOMEBODY ONGOING OVERSIGHT AND THEN TALK ABOUT THE COLLECTION OF SHARING KEY INFORMATION TO INFORM THE PROCESS. DOESN'T DO EXTENSIVE DETAIL BUT PROVIDES ENOUGH TO SAY THIS IS A ROAD MAP HOW TO KEEP THIS FLEXIBLE AND FUNCTIONAL OVERTIME AND WE NEED TO CARRY THAT FORWARD. MIKE BROUGHT UP THE SAFETY INFORMATION, THAT'S IMPORTANT FROM ADDITIONAL REASON, A LOT OF CONVERSATION ABOUT PROVISION OF INFORMATION ABOUT LABORATORY ACCIDENTS HAS BEEN PUT IN CONTEXT OF MAINTAINING OR REGAINING PUBLIC TRUST. AND ATTENTION BETWEEN CONCERN HOW PUBLIC RESPONDS WITHOUT FULLY UNDERSTANDING WHAT IS A SIGNIFICANT ISSUE, WHAT IS NOT. ALL THAT IS IMPORTANT. BUT PUTS IN A SLIGHTLY DIFFERENT CONTEXT, THERE IS INFORMATION THAT IS REALLY VALUABLE FOR US TO BE ABLE TO BETTER UNDERSTAND RISKS AND HOW BEST THE ADDRESS THEM SO PUTS THEM IN A PRAGMATIC FUNCTIONAL CONTEXT THAT WILL HELP DRIVE THE NEXT QUESTION ALSO GET TO HOW. SEEMS THAT'S A CRITICAL PIECE. WE HAVE TWO RECOMMENDATIONS THAT HAVE A DYNAMIC TENSION, ONE TO THE EXTENT POSSIBLE DOES THIS BUILD INTO THINGS YOU HAVE GOT RATHER THAN INFRASTRUCTURE AND APPLY TO PEOPLE YOU DON'T CURRENTLY HAVE THE ABILITY TO APPLY IT TO. THE SECOND IS GOING TO BE -- THEY'RE BOTH INTERESTING BUT BOTH VERY THOUGHTFUL AND HELPFUL POINTS. FINALLY I LIKE THE FACT YOU INCLUDED A COUPLE OF RECOMMENDATIONS ON COMPLIMENTARY MEASURES. EDUCATION OUTREACH ENGAGEMENT WITH THE INTERNATIONAL COMMUNITY, THOSE PIECES ARE VITAL, FOR A NUMBER OF REASONS INCLUDING THE IDEA THAT IF WE'RE GOING TO MAINTAIN THIS SYSTEM IN THE U.S. OVER TIME, THERE HAS TO BE AN ANSWER -- THEY DON'T DO THAT IN COUNTRIES X, Y AND Z SO ALL YOU'RE DOING IS PRESSING AMERICAN RESEARCHERS AND FORCING THE WORK DONE ABROAD. SO WE NEED THAT LEVEL OF ENGAGEMENT AND JOB SECURITY FOR THOSE AT THE STATE DEPARTMENT. SORRY TO REHASH THE WHOLE THING BUT THE STRUCTURE MAKES A LOT OF SENSE COVERING THE MAIN BASES. >> ANY OTHER COMMENTS? >> ONE POINT TO MAKE, I WASN'T GOING TO WEIGH ON SUCH AS BUT THE OTHER SPECIFIC WORDING ABOUT THE WORD EXTERNAL. I ALWAYS THOUGHT THE WORD EXTERNAL TO REMIND US IT'S NOT INTERNAL TO THE GOVERNMENT BECAUSE WE HAVE INTERNAL GOVERNMENT MECHANISMS SO IT'S CLEAR IN THE REPORT YOU DON'T MEAN INTERGOVERNMENT, I THINK THE WORD EXTERNAL IS A FLAG, GUYS YOU GOT TO GO OUTSIDE. SO RECOGNIZE, THAT'S THE VALUE I THOUGHT THAT WORD HAD. >> YOU DIDN'T BUY EX[EXPLETIVE] TERM. -- EXTERNAL. >> GOOD AFTERNOON. I WORK FOR AGRICULTURE RESEARCH SERVICE USDA. THERE ARE ABOUT # 1 LABORATORIES FOCUSING ON ANIMAL HEALTH. LOOKING AT THIS, FROM OUR PERSPECTIVE TO ECHO WHAT DENNIS SAID, I THINK EVERYTHING THAT YOU IDENTIFIED IS USEFUL, BUT IMPORTANTLY WE NEED DIRK AND OTHER FEDERAL REGULATIONS WITH SELECT AGENTS WITH COMPLIANCE AND WE CAN ACCOMMODATE THIS. FROM A SCIENTIFIC STANDPOINT I WANT TO SHARE WITH YOU, MOST OF YOU KNOW THAT, WE DON'T DO DIRC OR THIS TYPE OF RESEARCH, WE ARE IN A SITUATION TRYING TO LOOK AT PATHOGENS IN ANIMAL HOST. SO WE DON'T HAVE TO MANIPULATE THESE AGENTS TO DETERMINE WHAT POTENTIAL DETERMINANTS OF HOST OPERATING INCOME, VIRULENCE, ET CETERA, OUR AIM IS TO LOOK AT THE VARIOUS PATHOGENS EMERGING PATHOGENS AND TRY TO IDENTIFY VARIOUS DETERMINANTINGS BUT WE CAN DO IT DIRECTLY IN A RELEVANT HOST. WE NEED TO MONITOR THAT RESEARCH UNDER ALL THE DERC PARAMETERS AND WE DO SO. SO THAT HOE THANK YOU FOR THE HARD WORK. AND WE WON'T BE DOING ANYTHING RELATIVE TO HUMANS AS YOU IDENTIFIED THE CRITERIA. SO THANK YOU FOR THAT. >> THANK YOU. >> CHRIS (INAUDIBLE) FROM DOD. SINCE INJURY MENTIONED I THOUGHT I WOULD GET A COMMENT FROM THE DEPARTMENT. HAVING SPENT THE YEAR WITH FALL OUT FROM ANTHRAX SHIPMENTS, SHIPMENTS WHAT WE THOUGHT WERE INACTIVATED ANTHRAX SAMPLES. WE DUG INTO THAT AND LOOKED AT THIS -- THIS I'M COMMENTING ON IS LOOKING AT INCIDENT AND TRACKING THOSE. ONE THING WE FOUND OVER THE YEARS IS DEPARTMENT HAS RIGOROUS PROCESSES FOR DOING INSPECTOR GENERAL AND OTHER TYPES OF INSPECTIONS TO MONITOR AND DO OVERSIGHT AND TRACK INCIDENTS. WE WERE FINDING THAT CREATED A FALSE SENSE OF SECURITY, PEOPLE WERE GLARING THINGS WERE HAPPENING BUT NOT REPORTING THEM AND WHEN WE ASKED DURING THIS LAST YEAR DOING INTERVIEWS PEOPLE SAID THAT WASN'T PART OF THE OVERSIGHT. NO ONE ASKED ME ABOUT THAT. I DIDN'T HAVE TO REPORT THAT ON THE FORMS SO WE'RE TRYING TO FIGURE INTERNALLY SOMETHING MORE HOLISTIC HOW YOU CAN REPORT SEEING SOMETHING GOING ON VERSUS WAITING FOR FORMALIZED PROCESSES SO I SUPPORT THE NEED TO DO THIS AND ATTRACT -- I THINK ALSO OUTSIDE VIEW ON PROFESSIONAL SIDE LIKE GARY SAID OR SOMETHING BEYOND INTERNAL MIGHT GET BEYOND COMPLACENCY. AS WE PUBLISH AND FINALIZE THE REPORTING WE'LL BE HAPPY TO SHARE IT FOR THE COMMITTEE IN CASE THEY FIND IT FOR ANY USE. >> THANK YOU. >> I'M SHARLENE WEATHERWAX, ASSOCIATE DIRECTOR FOR BIOLOGICAL AND ENVIRONMENTAL RESEARCH. IN THE OFFICE OF SCIENCE APT THE DEPARTMENT OF -- AT THE DEPARTMENT OF ENERGY. WE APPRECIATE THE WORK OF THE COMMITTEE. I HAVE BEEN EX-OFFICIO SITTING IN ON THE WORKING GROUP AND I CAN SAY THAT THE DELIBERATIONS HAVE BEEN INTENSIVE AND WORKING GROUP WORKED VERY HARD. DEPARTMENT OF ENERGY INTEREST STEMS FROM THE FACT WE DON'T DIRECTLY ENGAGE IN RESEARCH AS OUR MISSION, OUR 7 NATIONAL LABORATORIES DO WORK IN STRATEGIC PARTNERSHIP WITH SPONSORING AGENCIES, SO IN THAT SENSE WE ARE SUBJECT TO AN INTERESTED IN THE CONDUCT OF THAT RESEARCH SO WE ADHERE TO POLICIES, RIGHT NOW WE JUST SEPTEMBER OUT NEXT ROUND OF INVENTORY, IT IS AN ONGOING PROCESS AND OUR LABORATORY RESEARCHERS APPRECIATE LEADERSHIP AND ADVICE THAT COMES FROM THIS TYPE OF BODY. IT HELPS TO ENGAGE DISCUSSION BECAUSE OUR INTEREST IS REALLY CONTINUING TO STIMULATE FUNDAMENTAL DISCOVERY RESEARCH. IN THAT SENSE, SOMETIMES THE TOOLS THAT WILL BE OBTAINED OR DEVELOPED TO DO VERY SPECIFIC THINGS IN THE BIOMEDICAL OR BIOPATHOGEN SPACE WILL BE BROADLY TRANSFERABLE AND VICE VERSA. SO WE APPRECIATE THE CONTINUE DIALOGUE AND WE APPRECIATE THE MECHANISMS THAT ARE IN PLACE TO ENSURE AMPLE GOVERNMENT INTERAGENCY DISCUSSIONS AND SOME ARE VERY ANIMATED, AS WELL AS THE DIALOGUE WITHIN THE COMMUNITY WHETHER IT'S WITHIN THE INSTITUTE OR ALSO THROUGH THE PROFESSIONAL SOCIETIES. SO I THINK WE APPRECIATE THAT AND WE THINK THE LANGUAGE IS ACCEPTABLE FOR US. >> THANK YOU. IF THERE'S NO OTHER COMMENTS. YES. >> I CAN'T RECALL DEPARTMENT OF COMMERCE ON THE LINE OR IN THE ROOM? >> THANK YOU FOR PROVIDING -- ANYBODY ON THE PHONE WHO WISHES TO MAKE A COMMENT? >> DEPARTMENT OF COMMERCE. HOE (OVERLAPPING SPEAKERS) >> GO AHEAD. SORRY. >> REPEAT THAT, PLEASE. >> BRENDAN FROM THE ENVIRONMENTAL PROTECTION AGENCY. >> YES. WOULD YOU LIKE TO MAKE A COMMENT. >> TO THE EFFECT THAT KEEPING THE SCALE OF OVERSIGHT IN SCALE WITH THE RISKS INVOLVED KEY TO IMPLEMENTATION EFFORT OF YOUR RECOMMENDATION, THEY'RE ALL VERY WORTHWHILE, EPA DOESN'T DO ANY GOFROC. THE ONLY DIRC RESEARCH WE DO IS SELECT AGENTS AND TOXINS LISTED IN THE FIRST TEST UNDER THE DIRK POLICY. BUT EVEN SO, ONCE THE DIRK POLICIES WERE PROMULGATED OR ISSUED BY THE WHITE HOUSE, WE HAD TO UNDERTAKE STANDARDS TO ADOPT POLICIES SO THEY COULD BE IMPLEMENTED IN E FIRST QUARTERA. THAT'S DETAILED WRITING OF EPA DI RK POLICIES ISSUES COLLECTION REQUESTS WITH OMB, ESTABLISHING AN AMENDMENT TO EPA ACQUISITION REGULATIONS TO INSERT KEY LANGUAGE INTO RESEARCH EXTRAMURAL CONTRACTS, INTERAGENCY AGREEMENTS AND GRANTS. AND I THINK IT'S JUST A CLASSIC CASE WHERE WE AS A REGULATORY AGENCY THAT DOES RESEARCH DOESN'T QUITE ALIGN WITH THE SAME KIND OF FOCUS THAT Y'ALL HAVE ON NIH RESEARCH PROGRAMS IN THIS AREA. >> THANK YOU, THAT'S AN IMPORTANT POINT TO MAKE. THANK YOU. >> MY NAME IS BETTY WITH DEPARTMENT OF COMMERCE. WE HAVE TO THE GOFROC AREA OF RESEARCH. I THINK OUR REGULATIONS DO COVER ANYTHING THAT HAS ANYTHING TO DO WITH THOSE PATHOGENS, ON THE AUSTRALIA GROUP AS WELL AS ON THE SELECT AGENT LIST. WE HAVE GOT TO THE OVERSIGHT AS LONG AS THE RESEARCH IS CONSIDERED FUNDAMENTAL, WE DON'T REQUIRE LICENSE FOR RESEARCHERS FROM OTHER COUNTRIES TO WORK ON THESE PATHOGENS BUT ONCE IF IT'S CONSIDERED -- IF IT'S CLASSIFIED RESEARCH THAT IS A DIFFERENT SCENARIO. SO AT THIS POINT IF THE RESEARCH RESULTS OF THE PUBLICATIONS ARE NOT GOING TO BE RESTRICTED, DEPARTMENT OF COMMERCE DON'T REQUIRE LICENSE FOR THAT PARTICULAR RESEARCH SO THAT IS CLEAR CUT DISTINCTION BETWEEN THE TWO. >> ANY OTHER COMMENTS FROM OUR EXOFFICIO? I WOULD LIKE TO TURN NOW TO PUBLIC COMMENT. WE HAVE A NUMBER OF PEOPLE WHO SIGNED UP. I WILL GO WITH THEM FIRST. INPUT IS IMPORTANT TO THIS DELIBERATIVE PROCESS. WE HAVE RECEIVED A NUMBER OF COMMENTS THROUGHOUT THE PROCESS SHARED WITH MEMBERS OF THE COMMITTEE, CIRCULATED TO THE FULL BOARD, AS SOON AS THEY'RE RECEIVED. WE SET A TIME IN EACH NSABB MEETING AS WELL AS NATIONAL ACADEMY WORKSHOPS TO HEAR ORAL COMMENTS. NOW I'LL INVITE PEOPLE TO COME FORWARD TO SPEAK TO THE MICROPHONE, LIMIT REMARKS TO THREE MINUTES. I WILL GIVE PRIORITY TO THOSE WHO SIGNED AT THE REGISTRATION TABLE FIRST, IF YOU SIGNED UP MAKE YOUR REMARKS AND AFTER THOSE PEOPLE ARE COMPLETE, THEY WILL BE FOLLOWED BY ANYONE ELSE WHO WISHES TO MAKE A COMMENT. AND I WILL ASK CRISS TO CONTINUE TO MONITOR THE N STAB BOX OR QUESTION ONE COMMENT HAS COME IN THROUGH THE BOX SO FIRST WILL CALL GEORGE RUDY TO COME FORWARD AND COMMENT. >> GEORGE RUDY. I'M A MEMBER OF THE FREDERICK COUNTY CONTAINMENT LAB COMMUNITY ADVISORY BOARD. FROM DISEASE I HAVE A COUPLE OF COMMENTS ON THE PRESENTATIONS. DR. KANABROCKY STARTED WITH A SLIDES THAT GAVE GOOD REFERENCES AND UP I WOULD LIKE TO GET A COPY OF THAT SLIDE BEFORE I LEAVE IF I CAN. NEXT IS HIS UNDER RECOMMENDATIONS NUMBER ONE, HE MENTIONED VERBALLY THE NEED FOR PUBLIC HEALTH OFFICIALS ON THE STATE AND LOCAL LEVEL TO BE INVOLVED BUT YET NO VERBIAGE IN THE RECOMMENDATION NOTING THAT. AND I RECOMMEND YOU GET SOME WORDS IN THERE TO THAT AFFECT YOU VERBALLY SET IT AND IT WAS RIGHT ON BECAUSE WE'RE HAVING AN AWFUL TIME GETTING THE STATE TO BELLY UP TO THEIR OBLIGATIONS ON THE SUBJECTS. THE NEXT COMMENT REFERS TO RECOMMENDATION FIVE IT IS A WORD ENGINEERING ACTIVITY WITHIN THE U.S. OR U.S. COMPANIES, AND AFTER THAT I WOULD LIKE TO SEE YOU ADD AND FOREIGN OWNED COMPANIES OPERATING WITHIN THE U.S.. WE HAVE AT LEAST TWO FOREIGN COMPANIES OPERATING IN FREDERICK AND SO IF YOU JUST SAY US COMPANY THAT IMPLIES U.S. OWNED. SO IF YOU ARE TO ADD THE VERBIAGE AND FOREIGN OWNED COMPANIES OPERATING WITHIN THE U.S., ONE SWISS ONE IS RUSSIAN, THANK YOU. >> THANK YOU. BETTY YOU'RE ON THE LIST. DID YOU WANT A COMMENT? YEAH. MAYBE THOUGHT IT WAS A SIGN UP LIST. TYLER JOHN. >> I'M TYLER JOHN AFFILIATED WITH NIH DEPARTMENT OF BIOETHICS BUT I'M REPRESENTING MYSELF AND NO INSTITUTION FROM THE FEDERAL GOVERNMENT. MY COMMENT HAS TO DO WITH PRINCIPLE FOR GUIDING REVIEW AND FUNDING DECISIONS, PRINCIPLE 3 HOW TO BEST CONDUCT RISK BENEFIT ASSESSMENTS FOR SOME OF THESE GOFROC PROJECTS SO I'M INTERESTED WHETHER THE ADVISORY BOARD AND THOSE WHO ARE GOING TO WORK TO IMPLEMENT THESE GOFROC RECOMMENDATIONS WOULD CONSIDER POLICY REQUIRING GOFROC RESEARCHERS TO GET INDEPENDENT ASSESSMENT TAKING INTO ACCOUNT SMALL RISK OF DEVASTATING PANDEMIC AND INCLUDE INTO THE COST OF RESEARCH PROJECT THIS WOULD HAVE THE ADVANTAGE OF INCENTIVIZING SPONSORS TO FUND RESEARCH WHEN SCIENTIFIC MERIT OUTWEIGHS THE COST BECAUSE OF POSITIVE -- POSSIBLE NEGATIVE EXTERNALITIES CONSIDERED PASS PART OF THE COST OF ARE SEMIPROJECT WITHOUT NEED FOR DIRECT COST BENEFIT ANALYSIS. I CAN MENTION TWO WAYS THIS IS ACCOMPLISHED. FIRST IS STRICT LIABILITY FOR DAMAGES THAT RESULT FROM GOFROC TO REQUIRE GRANT HOLDERS TO PURCHASE LIABILITY INSURANCE. AND IT'S MARKET BASED AND INCENTIVIZE INSURERS TO PRICE EXTERNALITIES CORRECTLY. THE SECOND WAY WOULD BE CENTRALLY COMMISSIONED ASSESSMENT OF ABSOLUTE RISK AND REQUIRE PAYMENT TO A STATE OR UNSTATE BODY TO COVER EXPECTED COSTS. EVEN IF THERE'S NO CLEAR LIABILITY AFTER THE FACT THIS ADDRESSES BIOSECURITY AND BIOSAFETY RISK AS WELL. SO MY COMMENT IS BY HAVING RISK PRICED INTO GRANTS WE CAN ENSURE GOFROC RESEARCH FUNDS THE RESEARCH WHEN BENEFITS PRECISELY WHEN BENEFITS OUTWEIGH THE RISKS OF THE RESEARCH. >> THANK YOU. ROCCO CASAGRANDE. GIVEN SCIENTIFIC. >> HELLO, I HAVE THE PI ON THE RISK BENEFIT ASSESSMENT BUT I'M SPEAKING AS MEMBER OF THE PUBLIC. COUPLE OF COMMENTS ON RELATIVE RISK. THE EVASION OF IMMUNITY. JUST BECAUSE I THINK SPECIFICALLY LINE 470 AND 1072 IN THE REPORT END IN APPENDIX C DOESN'T NECESSARILY COMPORT WELL WITH THE RISK FINDINGS WHERE THE RBA. IN THAT IN THE FINAL REPORT WE SHOWED THAT THE RISK OF PANDEMIC INFLUENZA CAN BE SIGNIFICANTLY INCREASED DUE TO STUDIES THAT ALLOW TO EVADE RESIDUAL IMMUNITY IN THE POPULATION BY ABOUT 100 FOLD. SO THAT MIGHT BE SOMETHING TO INCLUDE IN ADDITION TO SEASONAL AND AVIAN INFLUENZA AND PANDEMIC AND THAT'S PROVIDED ON 470 AND 1072. ALSO IN APPENDIX C SPECIFICALLY LISTED AS PROBABLY NOT OF CONCERN, IS AN EXPERIMENT THAT THROUGH ANGIOGENIC DRIFT MIGHT CHANGE ABILITY OF SEASONAL FLU TO EVADE EITHER INNATE OR RESIDUAL IMMUNITY. I DON'T REMEMBER WHICH. WHAT THE NSABB MEANS TO DO THERE IS EMPHASIZE ACT OWE GENIC DRIFT. HOWEVER IN EITHER CASE I DON'T KNOW HOW WELL THAT COMPORTS WITH SCIENCE SUGGESTING THAT EVEN ANGIOGENIC DRIFT CAUSES SIGNIFICANT CHANGE IN RISK OF SEASONAL FLU STRAIN IN THE POPULATION AND CAUSE ONE -- THE SAME SEROTYPE TO CHANGE FROM YEAR-TO-YEAR TO HAVE A SIGNIFICANT POTENTIAL TO SPREAD WITHIN THE POPULATION. VERY QUICKLY, ON BOX 4 THAT SUGGESTS DIFFERENT MEANS THAT COULD HELP IMPROVE BIOSAFETY CULTURE. I WOULD RECOMMEND ADDING SPECIFIC MEASURES IMPLEMENTED IN SOME OF THESE LABORATORIES UNDER THE MORATORIUM NOW IN PLACE IN SUM BUT NOT ALL. THAT WAS SECTION 6.3 IN THE REPORT AND BECAUSE THEY'RE BEING IMPLEMENTED IN SOME PLACES BUT NOT ALL, THOSE MIGHT BE THE LOWEST HANGING FRUIT TO IMPLEMENT IN MORE LABORATORIES. THAT -- THOSE SHOULD BE SPECIFICALLY MENTIONED. LASTLY APPENDIX C, THE -- I APPRECIATE YOU HAVE A STRONG EXAMPLE HOWEVER I THINK IT DESERVES CLARIFICATION BECAUSE AS YOU KNOW WILD TYPE ONE WE PULL OUT OF NATURE IS ALREADY RESISTANT TO CERTAIN ANTIBIOTICS SPECIFICALLY BETA LACK TIM AND SPECIFICALLY ERYTHROMYCIN. SO THE POINT TO MAKE THERE IS THAT ANY STUDY THAT WOULD MAKE THE STRAIN MORE TRANSMISSIBLE BY RESPIRATORY ROOT OF CONCERN BECAUSE IT HAS LEVEL OF ANTIBIOTIC RESISTANCE OR ONLY OF CONCERN IF OUR MAIN TOOLS TO DEFEND AGAINST SPREAD WHICH WOULD BE LIKE ESSENTIALLY PROPHYLAXIS, THOSE WHO MIGHT BE EXPOSED, DUE TO ANTIBIOTIC RESISTANCE. THAT'S AN IMPORTANT POINT THAT NEEDS CLARIFICATION ON THAT EXAMPLE WHICH IS OTHERWISE VERY VALUABLE. THANK YOU. >> BRIAN REARSON, GRIFFIN SCIENTIFIC. >> I LED THE RISK ASSESSMENT TASKER LIKE ROCCO I'M SPEAK AS A MEMBER OF A A THE GENERAL PUBLIC. I APPRECIATE THE REVISIONS TO DOCUMENT OVER THE LAST SEVERAL MONTHS, THANKS TO THE WORKING GROUP FOR THEIR HARD WORK DOING SO. LINE 67 OF THE CURRENT DRAFT COULD BE AMBIGUOUSLY READ AS I DID THE FIRST TIME TO INDICATE THAT GRIFFIN WAS RESPONSIBLE FOR RBA AND ETHICS PAPER. PANNED I SUGGEST IT'S CHANGED TO THOSE THAT WORKED ON THE PAPER ABOUT THE CREEP DATE DUE. MORE BROADLY, THE NEW OVERSIGHT PROCESS THAT NSABB IS RECOMMENDING I THINK COULD CAUSE SOME WHO DO INFECTIOUS DISEASE RESEARCH TO SHY FROM CERTAIN TYPES OF RESEARCH BECAUSE THEY ARE CONCERNED THE WORK COULD FALL UNDER GOFROC WITHOUT BEING ASSURED IT DOES. MANY RESEARCHERS WE SPOKE TO AT SITES VISITED AND RISK BENEFIT TOLD US THEY STOPPED WORK BECAUSE THEY WERE CONCERNED IT COULD BE SUBJECT TO MORATORIUM WITHOUT BEING SURE THAT IT WAS. SOMETIMES DUE TO SAFETY CONCERNS OTHER TIMES TO PUBLIC PERCEPTION DOING WORK THAT IS DANGEROUS, THE DEFINITION OF GOFROC IS MORE SUCCINCT AND UNDERSTANDABLE AND THAT WAS THAT RESEARCH COVERED ON THE MORATORIUM. BUT I STILL SUGGEST NSABB RECOMMEND A POINT OF CONTACT OR POINTS OF CONTACT BE IDENTIFIED FOR THE GOFROC OVERSIGHT PROCESS SO RESEARCHERS CONCERNED WHETHER OR NOT THE RESEARCH DOES FALL UNDER IT COULD GET A QUICK DETERMINATION IT DEFINITELY DOES NOT. THEREFORE FEEL FREE TO SUBMIT REQUEST FOR FUNDING. FINALLY PERHAPS A PERSONAL BIAS BECAUSE I WAS DIRECTLY AFFECTED BY LACK OF BIOSAFETY INCIDENT DATA TRYING TO DO THE BIOSAFETY RISK ASSESSMENT, APPRECIATE RECOMMENDATION 3.1 AT THE NSABBICS MANY, OTHERS BEFORE ME TALKED ABOUT SOME OF THE CHALLENGINGS AND IMPLEMENTING THAT. I WOULD LIKE TO REINFORCE THE TYPES OF DATA AND INCIDENTS INCLUDED IN THAT ARE CRITICAL TO DETERMINING THE OVERALL UTILITY OF A DATABASE. NEAR MISSES ARE INC ABLY USEFUL IN IDENTIFYING THE TYPES AND KINDS OF THE FREQUENT SUCH THAT LABORATORY SAFETY SYSTEMS CAN REDESIGN TO AVOID MISTAKES FROM HAPPENING IN THE FIRST PLACE. THANK YOU. >> CORY MYYER, ALSO GRIFFIN SCIENTIFIC. >> I LED THE BENEFIT ASSESSMENT COMPONENT OF RBA, ALSO SPEAKING AS A MEMBER OF THE GENERAL PUBLIC. I WANT TO MAKE RECOMMENDATIONS REGARDING SPECIFIC # GOFR OC RESEARCH PROJECTS TO TALK ABOUT RESEARCH DEVELOPMENTS. MANY EMPERIMENTS THAT MAY CONSTITUTE GOFROC DON'T NECESSARILY INVOLVE CONTINUOUS MONITORING OF TRANSMISSIBILITY AND VIRULENCE OF PATHOGENS GENERATED THROUGHOUT THE PROCESS OR EVEN AT THE END OF THE PROCESS, THAT DEPENDS ON THE SCIENTIFIC QUESTION BEING ASKED SO ONE SALIENT EXAMPLE WOULD BE EXPERIMENT ASSESSING ASSORTMENT COMPATIBILITY OF AVIAN INFLUENZA STRAIN AND HUMAN SEASONAL STRAIN TO UNDERSTAND IMPLICATIONS OF CO-INFECTION SO THIS IS SIMILAR TO ONE OF THE EXAMPLES AND YOUR APPENDIX, THE OUTPUT OF THAT EXPERIMENT MIGHT BE SIMPLY TO UNDERSTAND GENE COMBINATIONS ARE VIABLE. SO DO YOUR RECOMMENDATIONS IMPLY THAT EXPERIMENT AND ALL EXPERIMENTS THAT FALL UNDER GOFROC, THAT RESEARCHERS SHOULD BE MONITORING TRANSMISSIBILITY AND VIRULENCE THROUGHOUT AND IF SO I ENCOURAGE YOU TO CONSIDER IMPLICATIONS FOR THE RESEARCHERS, THOSE EXPERIMENTS REQUIRE SPECIALIZED EXPERTISE, TIME, MONEY, AND THEY'RE ALSO I THINK PATIENT FOR BIOSECURITY INFORMATION RISK. MY SECOND COMMENT PERTAINS TO THE DEFINITION OF GOFROC SO THERE'S TWO POTENTIAL POINTS OF CONFUSION THAT STEM FROM THE FACT THAT THE DEFINITION EXPLICITLY DOES NOT REFERENCE STARTING PATHOGEN SO I UNDERSTAND THE IMPETUS FOR THAT BUT THAT I THINK THE DEFINITION IS WRITTEN DOES NOT EXCLUDE EXPERIMENTS INVOLVE SLIGHT MODIFICATIONS TO WILD TYPE PATHOGENS THAT ARE ALREADY TRANSMISSIBLE AND VIRULENT SUCH AS SARS. CREATION OF GSP SARS STRAIN. IT IS NOT EXPECTED TO HAVE PROPERTIES MORE EXTREME THAN STARTING WILD TYPE PATHOGENS. A SECOND TYPE WOULD BE INTRODUCING GENETIC TRAITS FROM WILD TYPE PATHOGENS TO A SIMILAR LAB STRAIN IN ORDER TO UNDERSTAND PHENOTYPIC CONSEQUENCES YOU WOULDN'T EXPECT THE STRAIN THAT'S CREATED TO HAVE TRANSMISSIBILITY OR VIRULENCE THAT EXCEEDS THAT WILD TYPE PATHOGEN. BUT YOU ARE ENHANCING PROPERTIES OF LAB STRAIN AND CREATING SOMETHING THAT FULFILLS CRITERIA. ENCOURAGE YOU TO THINK ABOUT WHETHER THOSE TWO EXPERIMENTS SHOULD BE EXCLUDED, IF SO HOW TO CRAFT OR ADJUST THE DEFINITION. >> OTHER MEMBERS OF THE PUBLIC WHO WISH TO MAKE A COMMENT? THREE MINUTES PER COMMENT. >> WE RECEIVED ONE COMMENT ONLINE, I WILL TAKE A MOMENT TO READ, IT COMES FROM ROLAND CLARK, SUBJECT ENSURE WORDS HAVE COMMON MEANINGS. DEER NSABB WORDS ARE IMPORTANT ESPECIALLY ACROSS DIFFERENT LANGUAGES. I BELIEVE THE INTENT OF ANY WORD OR PROCESS BE DETERMINED TO HAVE A COMMON STANDING. I BELIEVE THERE SHOULD BE A FEDERAL OVERSIGHT DEPARTMENT FOR ALL BIOLABS TO ENSURE COMMON MEANINGS AND PROCESSES ARE UNDERSTOOD IN A SINGLE SOURCE OF REFERENCE, RESPECTFULLY SUBMITTED, ROLAND CLARK. >> SO YES. PLEASE IDENTIFY YOURSELF. >> NICHOLAS EVANS UNIVERSITY OF PENNSYLVANIA. THANK YOU TO THE BOARD FOR WHAT HAS BECOME A REALLY WELL DEVELOPED MATURE DOCUMENT AS PART OF THIS PROCESS, I HAD A COUPLE OF SMALL COMMENTS REGARDING CLARIFICATION AND TERMINOLOGY USED IN THE REPORT. FIRST IS TRANSPARENCY LISTED IN LINE 597 AS SUBSTANTIVE VALUE AS PART OF THIS DELIBERATIVE PROCESS. IT WOULD HELP FOR CLARITY SAKE TO KNOW WHAT -- WHO THE TARGET OF THE TRANSPARENCY IS THROUGH DELIBERATIONS TODAY I HAVE HEARD TRANSPARENCY REFERRED TO WITHIN THE UNITED STATES GOVERNMENT, WITHIN SPECIFIC UNITED STATES GOVERNMENT AGENCIES, INSTITUTIONS AND PROFESSIONAL SOCIETIES, RESEARCHERS AND PUBLIC. THESE ARE ALL DITCH KINDS OF TRANSPARENCY AND DO NOT MAKE ANY COMMENTS ON WHAT IS BEING SHARED AND WHAT IS OPEN SO WHEN REVIEWING TRANSPARENCY IN THE DOCUMENT SOME GREATER SPECIFICITY ON THAT TERM WOULD BE HELPFUL. OWN YOUR PROPOSED EXTERNAL REVIEW BOARD AS POINTED OUT, CLARIFICATION OF EXACTLY EXTERNAL TO WHAT WOULD BE HELPFUL. BUT ALSO WHETHER OR NOT EXTERNAL REVIEW BODY LOOKS AT OVERLAP AND OVERSIGHT MECHANISMS WITH GOFROC OVER SIGHT AS WELL AS OVERSIGHT AS IT STANDS BECAUSE AS I'M SURE YOU NOTICED, DIRK OVERSIGHT POLICY OVERLAPS WITH REVIEW BOTH PROCESSES OR GOFROC INDEPENDENT OF D ISHRK IS A REALLY SIGNIFICANT MISSION. FINALLY THE ONLINE 1331 ONCE PRINCE FELONY FOR REVIEWING GOFROC IS WHETHER OR NOT THE SCIENTIFIC EXPERIMENT HAS ALTERNATIVES WHICH AREN'T FOR THE -- ANSWER THE SAME QUESTION AND LATER ON 1337, THE WORDING IS SAME OR VERY SIMILAR QUESTION. THESE TWO DICTIONS AND WHICH -- DISTINCTIONS AND WHICH YOU PICK ARE REALLY IMPORTANT AS PART OF THE DEBATE UP UNTIL NOW OVER THE LAST TWO YEARS INCLUDED SUGGESTIONS THAT THERE IS IN FACT NO EXPERIMENT OTHER THAN GAIN OF FUNCTION EXPERIMENTS THAT ANSWER THE SAME SCIENTIFIC QUESTION AND THROUGH THE UNIQUENESS OF THE QUESTION THAT SHOULD JUSTIFY THE RESEARCH GOING FORWARDS. SO WHETHER OR NOT YOU MEAN EXACTLY THE SAME QUESTION OR SIMILAR QUESTIONS OR VALUABLE QUESTIONS IS IMPORTANT PART OF THAT PRINCIPLE, OTHERWISE IT BECOMES MEANINGLESS AS PART OF IT. THANK YOU. >> OTHER PUBLIC COMMENT? >> I'M SHERRY LONG WITH UNIVERSITY OF MARYLAND, I'M SPEAKING FOR MYSELF AS AS BIOSAFETY PROFESSIONAL. I APPRECIATE THE WORK DONE HERE, I HAVE BEEN FOLLOWING THESE MEETINGS A WHILE NOW. AND I WANT TO ENCOURAGE YOU TO CONSIDER IN ADDITION TO ENCOURAGING EDUCATION AND FACILITIES AND ALL THE UNDERSTANDING THAT AS THESE REGULATIONS GET PROMULGATED AND PUT DOWN THERE IS NO NEW IRE THAT COMES TO PICK UP, IT COMES DOWN THE BIOSAFETY OFFICER TO MAKE IT HAPPEN AND UNDERSTANDING THE NEEDS FOR SUPPORT FOR THE ALREADY ONS STAFFED AND OVERWORKED PEOPLE DOWN THERE TRYING TO MAKE THESE LISTS. ANY TIME THAT CAN BE DONE AT THIS LEVEL IT IS NOT ONLY MOTIVATIONAL TO THOSE IN THE TRENCHES BUT INCREDIBLY IMPORTANT WHEN LOBBYING FOR HELP IN THE ADDITIONAL RESOURCES. >> THANK YOU. OTHER COMMENTS? THANK YOU TO MEMBERS OF THE PUBLIC FOR YOUR COMMENTS, THEY HAVE BEEN VERY HELPFUL. THEY CAN BE FIXED BY CHRIS IF'S SOME THINGS THAT WERE INCORRECT AS THEY CAME FORWARD. ONE DR. MYER RAISED ABOUT EXPERIMENTS CONFUSED, WOULD YOU MIND AS WORKING GROUP CO-CHAIR TALKING ABOUT THAT AND ARE THOSE CAPTURED, NOT CAPTURED? DO YOU WANT TO REITERATE YOUR POINT TO MAKE CLEAR WHAT WE'RE TALKING ABOUT? >> TWO EXAMPLES YOU GAVE. >> TWO TYPES OF EXPERIMENTS THAT ARE EXPECTED TO GENERATE QUOTE UNQUOTE NOVEL PATHOGENS WITH PROPERTIES THAT SIMILAR TO WILD TYPE PATHOGENS SO ONE IS STARTING WITH SOMETHING THAT'S HIGHLY TRANSMISSIBLE AND VIRULENT LIKE SARS, MAKING A LATERAL MOVE AS SOME OTHER MODIFICATION DONE AS A TOOL GENERATE SOMETHING NEW SIMILAR PROPERTY AS WILD TYPE PATHOGEN. THE SECOND WOULD BE TO TAKE PROPERTY FROM WILD TYPE CIRCULATING PATHOGEN, GENETIC TRAIT AND STUDY IN YOUR LABORATORY STRAIN TO ISOLATE THAT PROPERTY. THAT MIGHT BE EXPECTED TO INCREASE THE TRANSMISSIBILITY OR VIRULENCE OF LAB STRAIN UP TO THE POINT OF THE WILD TYPE STRAIN CIRCULATING IN NATURE BUT NOT EXCEED TRANSMISSIBILITY OR VIRULENCE. OF THE STRAIN SO THAT'S A CRITICAL SCIENTIFIC TOOL FOR UNDERSTANDING WHICH ARE NECESSARY AND SUFFICIENT, IT'S A CRITICAL TOOL FOR RELYING ON ALTERNATIVE APPROACHES SURVEILLANCE BASED APPROACHES SO IT IS UNCLEAR FROM THE CURRENT DEFINITION WHETHER THAT EXPERIMENT WOULD BE EXCLUDED, IT'S IMPORTANT TO RESOLVE. >> ONE KEY FACTOR TO KEEP IN MIND IS WHETHER WHAT YOU WIND UP WITH IS SOMETHING TRULY AS PANDEMIC POTENTIAL AND IS DIFFERENT FROM WHAT ALREADY EXISTS IN NATURE. IF THAT'S THE CASE IT PROBABLY OUGHT TO COME UNDER. IF IT DOESN'T MEET THOSE CRITERIA, IT DOESN'T FALL UNDER THESE CONSIDERINGS. DISCUSSION QUESTION THAT CAME TO MY MINDS OF WHETHER OR NOT WHAT WE HAVE PROPOSED, WHETHER THAT DECISION IS MADE BY REVIEW PROCESS FROM WHEN A PROPOSAL IS MADE, SO THEN MY QUESTION IS, IS THERE ENOUGH IN THE DOCUMENT TO ALLOW THAT KIND OF FRAMEWORK TO ANSWER THAT QUESTION WHEN REVIEWING. >> THAT'S WAY I'M THAT IS MY THOUGHT THIS IS THE EDUCATION REVIEW PROCESS AT LEVEL OF PI, AT THE LEVEL OF INSTITUTION IT'S ALSO THE RESPONSE TO PREVIOUS QUESTION HOW TO ALERT PI AND SO ON, I THINK PART OF THIS, THIS IS DIRC IS EDUCATE PI AND INSTITUTIONS AND AS WE DEVELOP, SURE WE WILL WORK ON MATERIALS TO HELP, WE TOOK PRELIMINARY LOOK WITH EXAMPLES GAIN OF FUNCTION RESEARCH OF MS. O'CONNELL: CERTAIN AND NOT GAIN FUNCTION RESEARCH CONCERN, THAT COULD EXPAND, WE CAN ADD EDUCATIONAL MATERIALS BUT WE CAN HELP ASSESS THIS AND PEOPLE WILL GET TO GET THE OPPORTUNITY TO MAKE -- THERE MAYBE GRAY AREAS WHERE WE HAVE TO GO TO DEPARTMENTAL REVIEW BECAUSE IT WON'T BE COMPLETELY CLEAR AND THAT'S WHY WE'RE ESTABLISHING IT SO PROBABLY WE DON'T SEE A FUNDAMENTAL FLAW IN THE DRY TIERIA WE PUT FORTH. OTHER COMMENTS? PEOPLE RAISE THAT YOU WANT TO DISCUSS? THEY'RE HELPFUL. WE UNDERSTOOD STAFF WOULD GO OVER THE COMMENTS PANNED THIS IS REALLY A LIVING DOCUMENT TODAY PRESUMABLY THE BOARD WILL APPROVE WHATEVER THE REPORT IS AT THIS MOMENT BUT IT'S POSSIBLE TO MAKE -- >> I WOULD SAY MINOR EDITS WOULD BE DONE BUT NOTHING THAT WOULD CHANGE THE FUNDAMENTAL RECOMMENDATION, OUR GOAL TODAY IS TO MAKE OUR RECOMMENDATION, I THINK THERE COULD BE SMALL EDITS TO TAKE PLACE AND WE WILL VOTE ON SOME EDITS NOW TO LANGUAGE INCLUDING 3.2 AND SO ON TO INCORPORATE. SO I THINK THAT'S IMPORTANT. WE ARE PUTTING FORWARD TODAY A DOCUMENT THAT WILL BE OUR RECOMMENDATION. AGAIN, THE FEDERAL GOVERNMENT CAN DO WHAT IT WANTS AFTER THAT RECOMMENDATION COMES THROUGH THAT'S AN IMPORTANT COMPONENT OF IT. WHY DONE WE -- YES. >> I LIKE THE ADDITION OF NEAR MISS TO 3.1, NOT JUST A LABORATORY SAFETY ACCIDENT, U THINK IT CAME UP TWICE. >> NEAR MISS. >> WE ARE GETTING CLOSE TO A POINT WHERE WE CAN HAVE A MOTION TO VOTE ON THIS THEN ASK CHRIS TO GO THROUGH WITH THE LANGUAGE AMENDMENTS THAT WE TALK ABOUT. THE ONLY ONE I DON'T THINK WE HAVE CONSENSUS ON YET IS EXTERNAL AND SUCH AS WE NEED TO CLARIFY BECAUSE WE HAVE NEW INFORMATION. IF WE GET TO THAT, WE'RE READY. >> DR. EVANS RAISED A LANGUAGE POINT THAT I THINK IS SIGNIFICANT, PERHAPS TAKE A MINUTE TO ADDRESS WHICH IS ATE PARENTALLY ONE PLACE WE USE ANSWER THE SAME QUESTION AND THE OTHER THE SAME OR SIMILAR QUESTION. THERE WAS A LOT OF DISCUSSION WHETHER YOU ANSWER THE SAME QUESTION OR WHETHER YOU NEED TO ADDRESS THE SAME UNDERLYING PUBLIC HEALTH NEED WHICH IS A VERY DIFFERENT THING. SAME OR SIMILAR QUESTION IS POINT SOMEWHERE IN BETWEEN. SUGGESTING TO ME YOU MAY HAVE A QUESTION THAT IS FORMULATED, IN SUCH A WAY ONLY ANSWERED BY THIS EXPERIMENT BUT MAYBE ABLE TO ELUCIDATE THE SAME ISSUE WITH A DIFFERENT FORMULATION. I DON'T HAVE A STRONG VIEW ON WHICH IT IS. BUT IT DOES SEEM TO BE THAT IF THE REPORT CONTAINS BOTH FORMULATIONS, THEN I TAKE IT BACK. THE WAY IT IS BECAUSE WE DECIDE WHATEVER WE LIKE. >> I THINK THERE'S TRUTH TO THAT. COMMENTS FROM FROM THE WORKING GROUP ON THAT PARTICULAR LANGUAGE? DO WE LOSE IT SOMEWHERE QUESTION ABOUT ONE IS SAME, ONE IS IMIS. IN THE ACTUAL RECOMMENDATION IT SAYS THE SAME QUESTION. >> LINE 1431, IN BOLD IT SAYS SAME AND IN THE TEXT BELOW IT IS THE SAME OR SIMILAR. MARK MADE THE SAME COMMENT AS WELL. >> 1331. >> STRAPPING LANGUAGE FOCUSING HON THE ANSWER, MUCH EASIER TO HAVE THE SAME QUESTION THAN SIMILAR ANSWERS, WONDERING IF THAT'S HELPFUL. >> WHERE IT SAY IT IS SAME OR VERY SIMILAR INFORMATION. SAME QUESTION, HERE ARE THE SAME OR SIMILAR INFORMATION. SO IT IS EQUIVOCATING IN SOME WAY. SAME QUESTION BUT THE INFORMATION MIGHT BE THE SAME OR SIMILAR, SHOULD WE STRIKE SIMILAR? FEEL COMFORTABLE STRIKING SIMILAR? ON THE INITIAL PHRASE YOU CAN SWITCH TO INFORMATION. TO ATTAIN THE SAME OR SIMILAR INFORMATION OPPOSED TO ASKING THE QUESTION. >> I LIKE SIMILAR BECAUSE OTHERWISE IT HAS POTENTIAL TO BECOMEOXI MORONIC WHERE IT'S NOT THE SAME EXPERIMENT BUT HOW POSSIBILITY GIVE THE SAME INFORMATION. ALLOWS THE SCIENTIFIC DISCRETION. MODIFYING THE EXPERIMENT. (OFF MIC) >> WE DON'T KNOW EXACTLY WHAT IT WILL PROVIDE. RIGHT? SOME SENSE YOU'RE DOING AN EXPERIMENT, YOU'RE ASKING A QUESTION, WHETHER IT'S GOING TO PROVIDE THE SAME ANSWER BUT THE SAME I THINK WE SHOULD RETURN TO THE QUESTION AGAIN. IT HAS TO ADDRESS THE SAME SCIENTIFIC QUESTION. SO MAYBE WE NEED TO CHANGE THAT WORDING SO IT'S NOT WHAT KIND OF INFORMATION PROVIDE BECAUSE THAT'S POSSIBLE BUT RATHER CAN IT ADDRESS THE SAME QUESTION. DOES THAT MAKE SENSE TO PEOPLE IN THAT WAS HELPFUL. THANK YOU. WE'LL DO THAT. LET'S TALK ABOUT EXTERNAL AND SUCH AS T. SO FIRST, SUSAN, YOU ORIGINALLY THOUGHT WE COULD GET RID OF EXTERM, YOU HEARD DR. EPSTEIN BECAUSE MINIMUM DIFFERENTIATED WITHIN GOVERNMENT AND OUTSIDE OF GOVERNMENT SO THOUGH IT'S NOT THE STAFF THAT DESIGNS FACA ARE YOU COMFORTABLE WITH THE WORD IN THERE OR NOT? >> I TAKE THE POINT BUT I THINK OTHER PEOPLE LESS CONVERSANT WILL READ IT TO MEAN TOTALLY OUTSIDE THE GOVERNMENT. THAT'S NOT WHAT A FACA COMMITTEE IS. SO TRYING TO AVERT MISUNDERSTANDING. INDEPENDENT IS ANOTHER WORD. THAT MAY COMMUNICATE SOMETHING LIKE EXTERNAL BUT NOT MAKE THE CLAIM IT'S DIVORCED FROM THE FEDERAL GOVERNMENT. LET ME POSE ANOTHER WAY, DO PEOPLE THINK THERE'S A MECHANISM OTHER THAN FACA THAT WE KNOW ABOUT THAT MEETS THE NEEDS OF WHAT YOU SEE FOR THIS ADVISORY COMMITTEE. IF IT EXIST THERE'S AMBIGUITY HERE. WE RECOMMEND THE FACA COMMITTEE UNLESS SOMEBODY WHO DOESN'T THINK THAT'S WHAT WE'RE RECOMMENDING. >> I'M OFFERING AS AN OBSERVATION, IT IS NOT UNIAL TO SEND THINGS TO THE INSTITUTE OF MEDICINE AND NATIONAL ACADEMY OF SCIENCE FOR EXTERNAL ADVICE THAT IS NOT -- >> >> THAT MAY BE TRUE (OVERLAPPING SPEAKERS) WHEN YOU HAVE -- WE THINK AN OVERSIGHT GROUP OF THE NATIONAL ACADEMY SHOULD BE SET UP TO DO THAT. THAT'S -- >> BUT THAT COMES UNDER FACA AND THAT WAS A BIG ARGUMENT, YET IT WAS THAT WAS A BONE OF CONTENTION IN TERMS OF WHO HAD TO BE OPT COMMITTEE. SO NOT SURE THAT'S A DISTINCTION. >> I'M ASKING DOES FACA FIT EVERYTHING YOU WANT FOR THIS AND ARE THERE OTHER THINGS INCLUDED. THAT'S WHAT I'M ASKING. SO OTHER CONSTRUCTS. IF YOU WANT TO LEAVE OTHER POSSIBLY CONSTRUCTS THAT'S FINE. I'M AGNOSTIC OF THIS ISSUE. I WANT TO UNDERSTAND WHAT THE COMMITTEE THINKS. ABOUT THIS. BECAUSE I THINK WHERE YOU CAN BE EXPLICIT IS WORTH BEING EXPLICIT. WHERE YOU DON'T WANT TO BE EXPLICIT AND LEAVE IT TO THIS GROUP TO HAVE RAT TUESDAY, THAT'S FINE. DR. EPISTEEP WAS VERY GOOD ABOUT NOT EXCEEDING BOUNDARIES BUT HE SAID DID YOU SAY FACA THAT'S WHAT THEY'RE DOING TO THINK ABOUT. YOU CHANGE THE BAR A LITTLE BIT. SAY IT COULD BE SUCH AS, MAYBE SOMETHING NOT QUITE FACA BUT SOMETHING DIFFERENT SO THE COMMITTEE NEEDS TO HELP ME UNDERSTAND WHAT YOU WOULD LIKE TO DO WITH THIS. >> MIGHT NOT NECESSARILY HAVE TO BE FACA. MAYBE MY UNDERSTANDING IS NOT GOOD HERE BUT FOR INSTANCE INSTITUTES HAVE BOARDS OF SCIENTIFIC COUNSELORS WHICH ARE REALLY NON-GOVERNMENTAL PEOPLE WHAT THEY'RE DOING EXACTLY SOME OF THE WAYS WE'RE RECOMMENDING HERE. AND I THINK THAT'S A DISTINCT -- SO I'M NOT SURE WE WANT TO BE TOO PRESCRIPTIVE IN TERMS OF EXTERNAL GROUP WE RECOMMEND. >> I THINK THEN THAT TO ME LIEN ON SIDE OF SUCH AS. LIEN ON SIDE OF CONTINUING TO USE IT AS SUCH AS EXTERNAL, STRIKE, NOT STRIKE. GIVE ME A SENSE. I DON'T THINK IT MAKE AS BIG DIFFERENCE HONESTLY. SUCH AS FACA IN THERE. SO STRIKE EXTERNAL. ALL IN FAVOR. >> ALL IN FAVOR OF STRIKING EXTERM, RAISE YOUR HAND PLEASE. THANK YOU. ALL IN FAVOR OF KEEPING EXTERNAL. SO WE'RE GOING TO STRIKE EXTERNAL AND KEEP SUCH AS. THANK YOU. OTHER THINGS WE NEED TO DO, WE HAVE LANGUAGE FOR PEOPLE NOW FOR 3.2, PEOPLE COMFORTABLE WITH THAT LANGUAGE? >> THERE WERE AMENDMENTS MADE TO THE LANGUAGE >> THERE WAS THE THING ABOUT ARE YOU TALKING ABOUT NEAR MISS OR WHAT OTHER -- >> THE AMENDMENT WILL INSERT THE WORD OR FACILITATING. THE US GOVERNMENT CONSIDER DEVELOPING OR FACILITATING A SYSTEM TO COLLECT AND ANALYZE DATA ABOUT IRE CHALLENGES DECISIONS AND LESSONS LEARNED TO PROVIDE FEEDBACK. >> PERFECT. I LIKE THE WORD FACILITATE. ANY OTHER THINGS PEOPLE WANT TO HEAR? THEN WITH THESE EVENTS, WITH CORRECTIONS THAT FACTUAL THINGS THAT COME UP WITH GRIFFIN COULD I HAVE A MOTION TO MOVE OUR REPORT AND FINALIZE OUR REPORT AND SUBMIT TO FEDERAL GOVERNMENT? >> SO MOVED. >> KEN, THANK YOU. >> SECOND. >> SECOND BY JOE. ALL MEMBERS IN FAVOR OF SIGNIFY BY SAYING AYE. >> AYE. >> ANY OPPOSED? ON THE PHONE? >> AYE. >> FANTASTIC. MOTION CARRIES UNANIMOUSLY. MEMBERS OF THE WORKING GROUP, THANK YOU SO MUCH FOR ALL OF YOUR EFFORTS. IT WAS FANTASTIC EFFORT. I APPRECIATE IT SO I THINK WE HAVE DONE EXCELLENT WORK TODAY. I'M VERY PLEASED WITH THE JOB THIS COMMITTEE HAS DONE AND I'M CONFIDENT THAT OUR RECOMMENDATION TODAY WILL BE AMONG THE NSABB'S REPORT: IF WE THINK GAIN OF FUNCTION RECOMMENDATIONS IN THE CONTEXT OF A BROADER RECOMMENDATIONS ON DUAL USE RESEARCH OVER THE YEARS, I THINK THERE'S SOME NOTABLE SIMILARITIES. WHAT IMPORTANT POINT IS WE SPELL OUT A NEW REVIEW PROCESS FOR CAREFULLY EVALUATING GAIN OF FUNCTION RESEARCH OF CONCERN BEFORE IT IS FUNDED. THIS IS AN IMPORTANT POINT. AND IT'S CONSISTENT WITH OUR THINKING OVER THE YEARS. THE NSABB NOTED MANY TIMES HOW DIFFICULT IT IS TO MANAGE DUAL USE RESEARCH AT THE PUBLICATION STAGE BUT CALLING FOR A PRE-FUNDING REVIEW OF GAIN OF FUNCTION RESEARCH OF CONCERN WE CAN START TO AVOID SITUATIONS WHERE DUAL USE RESEARCH OF CONCERN IS ONLY FIRST IDENTIFIED AT THE PUBLICATION STAGE. SO HOPE OUR GAIN OF FUNCTION RECOMMENDATIONS COUPLED WITH THE NEW US GOVERNMENT POLICIES FOR OVERSIGHT WILL ESTABLISH A SYSTEM WHERE DIRK IS IDENTIFIED EARLY AND BIOBIOSAFETY AND BIOSECURITY IS MANAGED DURING THE COURSE OF THE WORK. WHAT ARE NEXT STEP? THE I WILL ASK NIH TO FINALIZE THE REPORT AS I HAVE SAID BEFORE BASED ON OUR DISCUSSION TODAY. THEY WILL INCORPORATE ALL THE CHANGES AND EDITS NEEDED. I WILL REVIEW THE FINAL REPORT AND THEN ASK NIH TO OFFICIALLY SUBMIT IT TO THE NIH DIRECTOR HEALTH AND HUMAN SERVICES SECRETARY AND THE HEADS OF ALL FEDERAL DEPARTMENTS AND AGENCIES. THEN AS WE HEARD THIS MORNING US GOVERNMENT WILL CONSIDER OUR RECOMMENDATIONS AND BEGIN FORMULATING POLICY. I WILL REITERATE THERE'S STILL A CHANCE TO COMMENT ON THIS FINALIZED REPORT. THAT CAN BE DONE AT NSABB.OD.NIH.GOV. THESE COMMENTS WILL NOT ALTER THE FINAL REPORT WHICH IS NOW AS I SAID WHICH IS NOW FINAL BUT THEY WILL BE FORWARDED TO OSTP TO INFORM THE POLICY PROCESS. I WANT TO THANK OUR FEDERAL PARTNERS FOR INVOLVING THE NSABB AND GAIN OF FUNCTION DELIBERATIVE PROCESS AND THE COMMITTEE STANDS READY TO ASSIST IN ANY WAY AS THIS PROCESS MOVES FORWARD SO FEEL FREE TO CALL UPON US IN ANY WAY SHAPE OR FORM. BEFORE WE ADJOURN I WANT TO SAY A FEW WORDS ABOUT FUNDING PAUSE, A NUMBER OF PROJECTS HAVE BEEN ON PAUSE FOR OVER A YEAR AND A HALF. THIS PAUSE IS NOT ONLY AFFECTED -- HAS ONLY AFFECTED A HANDFUL OF PROJECTS BUT I'M CONCERNED A BROADER EFFECT ON INFECTIOUS DISEASE RESEARCH COMMUNITY, WORRIED THE PAUSE HAS CREATED UNCERTAINTY IN MINDS OF MANY RESEARCHERS AND MAY HAVE CONTRIBUTED TO SOME YOUNG SCIENTIST RETHINKING RESEARCH CAREERS IN CERTAIN AREAS. I HOPE THIS IS NOT THE CASE. WE NEED TO CONTINUE TO ATTRACT THE BEST AND BRIGHTEST IN THESE IMPORTANT AREAS OF SCIENCE. SO AGAIN, WITH THIS IN MIND ENCOURAGE OUR FEDERAL COLLEAGUES TO MOVE ADS QUICK AS POSSIBLE TO LIFT THE MORATORIUM AND REPLACE IT WITH THE NEW REVIEW AND OVERSIGHT PROCESS FOR GAIN OF FUNCTION RESEARCH OF CONCERN. A NEW OVERSIGHT PROCESS IS OPPOSED TO DEFAULT FUNDING PAUSE WILL PROVIDE CLARITY TO THE RESEARCH COMMUNITY AND HOW GAIN OF FUNCTION PROJECTS WILL BE EVALUATED PRIOR TO BEING FUNDED. HELP SET EXPECTATIONS HOW STUDIES SHOULD BE CONDUCTED SAFELY AND PROVIDE ASSURANCE THAT CERTAIN PROJECTS ARE GIVEN GREATER SCRUTINY AND ONGOING OVER SIGHT. FINALLY I WANT TO THANK THE INDIVIDUALS WHO CONTRIBUTED TO THE DELIBERATIVE PROCESS AND MAKE OUR RECOMMENDATIONS POSSIBLE. FIRST AGAIN I WANT TO THANK ALL MEMBERS OF THE COMMITTEE AS I SAID THE WORKING GROUP AND THE FULL COMMITTEE DID A SUPERB JOB WITH A DIFFICULT TASK. ON A PERSONAL NOTE IT'S A PRIVILEGE TO CHAIR THE COMMITTEE AND WORK WITH AN OUTSTANDING GROUP OF COLLEAGUES DURING THIS IMPORTANT PROJECT. SO THANK YOU. I ALSO WANT TO THANK THE EX-OFFICIOS AND FEDERAL COLLEAGUES WHO CONTRIBUTED TO THIS PROCESS. YOUR SCIENTIFIC POLICY AND OTHER EXPERTISE HAS BEEN ESSENTIAL AND CONTRIBUTED TO MAKING OUR RECOMMENDATIONS THOROUGH AS WELL AS I HOPE PRACTICAL. I WOULD ALSO LIKE TO THANK THE NATIONAL ACADEMIES GRIFFIN SCIENTIFIC AND PROFESSOR MICHAEL WHO PLAYED AN IMPORTANT ROLE IN THE DELIBERATIVE PROCESS. THE WORK SHOPS HOSTED BY THE ACADEMIES WERE VALUABLE AND PROVIDE AN IMPORTANT PUBLIC FORUM TO DISCUSS THESE ISSUES AN ALLOWED US TO RECEIVE INPUT FROM INTERNATIONAL AND DOMESTIC EXPERTS THAT WAS CRITICAL TO OUR EFFORTS. GRIFFIN SCIENTIFIC WORK ON RISK AGAIN ASSESSMENT WAS OUTSTANDING, IT WAS A DIFFICULT TASK THAT NEEDED TO BE COMPLETED IN A TIGHT TIME FRAME BUT SOMEHOW GOT IT DONE AND ONLY TOOK 1,001 PAGES. DR. STANLEY'S COMMISSION ANALYSIS WAS DONE AS WELL. THE UNIQUE FEATURE OF THE NSABB PROCESS IS A DELEGATION TOP THE ISSUE. HE HELPED US APPLY ETHICAL PRINCIPLE AND WAYS TO MAKE DECISIONS TO BALANCE RISK AND BENEFIT. I WANT TO THANK CHRIS VIGGIANI AND THE NIH STAFF WHO SUPPORTED NSABB DURING THIS PROCESS, THEY MANAGED THIS DELIBERATIVE PROCESS AND HELPED KEEP OUR DELIBERATIONS ON TRACK. SO NOW WE'VE COMPLETED OUR TASK AND WE HAVE YET TO DO YET ANOTHER COMPLETELY CORRECT ACRONYM BUT TO NETTICLY CHALLENGING, GOFROC AND DURK, AS LEXICONS, SO THANK YOU EVERYBODY FOR PARTICIPATING IN THIS MEETING. COULD I HAVE A MOTION TO ADJOURN? >> SO MOVED. >> SECONDED. ALL IN FAVOR SAY AYE. THANK YOU VERY MUCH AND SAFE TRAVELS.