>> WELCOME BACK, EVERYBODY. LET'S REASSEMBLE FOR THIS PRESENTATION FROM OUR DISTINGUISHED GROUP OF EXPERTS RELATED TO STEM CELLS. AS YOU KNOW AT EVERY ACD MEETING, WE INVITE OUR STEM CELL WORKING GROUP TO COME AND PRESENT THEIR LATEST FINDINGS AND ASK ACD TO RESPOND. THE STEM CELL WORKING GROUP ONCE AGAIN WE HAVE WITH US JEFF BOTKIN, PROFESSOR OF PEDIATRICS UNIVERSITY OF UTAH WHO HAS SERVED NOBLY AND ABLY IN THIS ROLE, AND JEFF, WE'RE REALLY GRATEFUL TO YOU FOR THE HARD WORK REPRESENTED BY THESE MANY ITERATIONS, THE DELIBERATIONS WE'VE ASKED YOU UH TO DO. STORY LANDIS WHO IS THE DIRECTOR OF NINDS ALSO WITH US AS THE SENIOR NIH REPRESENTATIVE OF THE STEM CELL WORKING GROUP DELIBERATIONS. ONE OF THE REVIEWERS, DR. DAVID GRANGER FROM THE UNIVERSITY OF KANSAS IS SUPPOSED TO BE ON THE PHONE. ARE YOU THERE? >> I AM HERE. >> TERRIFIC. WELCOME. >> -- HE'LL BE ABLE TO ANSWER ANY QUESTIONS THE ACD MAY HAVE. THE WORKING GROUP REPORT AND SUPPLEMENTAL DOCUMENTS WILL BE AVAILABLE ON THE ACD WEB SITE WHEN THIS PRESENTATION COMMENCES, AND THAT ADDRESS FOR PEOPLE ON THE WEB IS HTTPOCD.AD.NIH.GOV. A COMPLETE PAPER COPY IS AVAILABLE HERE AT THE BACK TABLE FOR PUBLIC INSPECTION, BUT IT IS RALLY VE LUMINOUS. WE'RE CONTINUING REVIEW OF INFORMATION ABOUT PARTICULAR HUMAN EMBRYONIC STEM CELL LINES AND DETERMINING WHICH ONES MEET THE ETHICAL REQUIREMENTS DETAILED IN THE POLICY. YOU'LL HEAR ABOUT TWO MORE SETS OF LINES TODAY. JUST TO GIVE YOU THE CURRENT STATUS OF APPROVALS FOR THE LINES YOU HAVE REVIEWED IN AGREEMENT WITH YOUR RECOMMENDATIONS, ACD, I HAVE APPROVED 44 LINES FORKER USE BY NIH-FUNDED RESEARCHERS AND DECLINED 59. I'VE ALSO APPROVED 92 LINES AFTER NIH ADMINISTRATIVE REVIEW. YOU MAY REMEMBER THAT FOR APPLICATIONS WHICH VARY DIRECTLY RESPOND TO ALL OF THE CRITERIA, THERE IS A PATHWAY FOR ADMINISTRATIVE REVIEW. THE ONES THAT GO TO THE WORKING GROUP ARE THOSE WERE SO SOME DELIBERATION IS NEEDED. WE HAVE 136 LINES THAT HAVE BEEN APPROVED FOR US NIH-FUNDED RESEARCHERS TO UTILIZE. YOU PROBABLY ALSO AWARE SINCE THE LAST TIME WE MET THERE HAVE BEEN SEVERAL DEVELOPMENTS IN THE ON GANG LITIGATION CONCERNING STEP CELL POLICY. ON AUGUST 27th, THE U.S. DISTRICT COURT RULED IN FAVOR OF THE GOVERNMENT AND GRANTED OUR MOTION FOR SUMMARY JUDGMENT. TO THE LAYMAN, THIS MEAN THE JUDGE HELD RESEARCH UNDER THE NIH GUIDELINES DOES NOT VIOLATE THE LAW. WE WERE VERY PLEASED WITH THAT OUTCOME, BUT THE CASE IS NOT YET OVER. THE PLAINTIFFS APPEALED THAT RULING TO THE U.S. COURT OF APPEALS FOR THE D.C. CIRCUIT AND BRIEFING EXTENDS TO MARCH 2012. STAY TUNED. AT THIS POINT, I'D LIKE TO TURN THIS OVER TO DR. BOTKIN WHO HAS PREPARED TO WALK US THROUGH THE LATEST DELIBERATIONS OF THE WORKING GROUP. AGAIN, THANK YOU, JEFF. >> THANK YOU. PRIVILEGE TO BE BACK, AND, UH, PRIVILEGE TO REPRESENT THIS GROUP WITH MY COMMENTS TODAY, IT'S REALLY BEEN AN OUTSTANDING WORKING RELATIONSHIP WITH THIS GROUP, SO MY THANKS TO EVERYBODY, AND CERTAINLY, THANKS TO STORY LANDIS, DR. GEBWA AND DR. HONAMAN FOR THEIR HELP. PARTICULAR THANK TODAY TO DAVID GRANGER. HE DID WORK WITH THE GWANJU APPLICATION WE'LL BE DISCUSSING TODAY. SO QUICK REVIEW OF THE DIVIDELINES, THEMSELVES. WENT INTO EFFECT JULY OF 2009, ALL EMBRYONIC STEM CELLS MUST BE DERIVED FROM -- FOR REPRAUKTIVE PURPOSES AND NO LONGER NEEDED FOR THAT PURPOSE. THESE HAVE TO BE RESIDUAL. SECONDLY DONATED BY INDIVIDUALS WHO SOUGHT REPRODUCTIVE TREATMENT, WHO GAVE WRITTEN CONSENT. REALLY, MOST OF OUR CONCENTRATION OF OUR GROUP IS IS ON THE INFORMED CONSENT PROCESS AND MAKING SURE FOLKS ARE MAKING INFORMED CHOICES ABOUT THE FATE OF THEIR EMBRYOS. THERE'S THE 2 A CRITERIA. THESE GO THROUGH NIH ADMINISTRATIVE REVIEW, AND THESE ARE FOR RECENTLY-K ACQUIRED FUTURE U.S. DONATIONS THAT HAVE TO MEET THESE MORE DETAILED CRITERIA, OR OLDER LINES CAN GO THROUGH 2 A IF THEY MEET THE CRITERIA. THAT BECOMES A MATTER FOR NIH REVIEW AND IF THEY DON'T MEET 2 A CRITERIA, THEN THEY'RE REFERRED TO OUR GROUP FOR FURTHER EVALUATION. SO OVERLINES PRIOR TO THE 2009 DATE ARE UNDER THE 2 B CRITERIA. THOSE ARE SOMEWHAT MORE FLEXIBLE. THEN THERE'S 2 C AS WELL THAT'S AVAILABLE FOR LINES COMING IN FROM OUTSIDE THE UNITED STATES. SO THE PROCESS IS, WE REVIEW THEM AND MAKE FINDINGS. THOSE FINDINGS ARE PRESENTED TO THE ACD. THE ACD THEN MAKES, I BELIEVE, RECOMMENDATIONS IS THE CORRECT TERM TO THE DIRECTOR, AND THEN DR. COLLINS MAKES THE FINANCIAL DECISION ON THESE. FINAL DECISION ON THESE. HERE ARE TWO B CRITERIA. INTO ACCOUNT THE PRINCIPLES IN 2 A AND THE HUMAN SUBJECTS REGULATIONS UNDER 45 CFR 46 SUB PART A AND WE HAVE SEVERAL POINTS TO CONSIDER. NOT HARD CRITERIA, BUT POINTS TO CONSIDER. IN THE [INDISCERNIBLE] PROCESS, WHERE FOLKS ARE INFORMED OF OTHER [INDISCERNIBLE] WERE THEY OFFERED ANY INDUCEMENTS AND WERE THEY INFORMED OF WHAT WOULD HAPPEN TO THE EMBRYOS IN THE PROCESS. YOU NOTICE THESE ARE THOUGHTFUL GUIDELINES BUT NOT EXHAUSTTIVE. DR. COLLINS MENTION WRD WE ARE AT THIS POINT OR WHERE THE NIH IS WITH RESPECT TO THE APPROVAL OF LINES, SO, UM, NUMBERS HERE ALSO DILS APPROVED AS MENTIONED, 59 LINES. SO TWO APPLICATIONS WE'RE GOING TO TALK ABOUT TODAY; UNIVERSITY OF QUEENSLAND WITH FOUR LINES AND GWANJU MEDICAL COLLEGE, SIX LINES. UNIVERSITY OF QUEENSLAND SUBMISSION OWNERSHIP RECENTLY TRANSFERRED TO UNIVERSITY OF QUEENSLAND IS FOUR LINES, TWO IN 2004, TWO IN 2005 FROM PATIENTS AT THE MEL BORNE IBF FERTILITY CLINIC. -- THIS WAS ORIGINALLY SUBMITTED DESPITE THE AGE NUMBER THE 2 A CRITERIA. AFTER ADMINISTRATIVE REVIEW IT WAS MOVED TO OUR EVALUATION BECAUSE OF CONCERN ABOUT THE POSSIBILITY OF LANGUAGE THAT MIGHT BE EXCULL PRATORY. THEY HAD A THREE-PART EMBRYO DONATION CONSENT PROCESS. THIS WAS AN EXCELLENT SUBMISSION IN TERMS OF ITS COMPLETENESS AND CLARITY. THE CONSENT PROCESS ITSELF IS DIFFERENT THAN WHAT WE DITCHLY SEE OUT OF U.S. INSTITUTIONS, BUT REALLY WAS CLEARLY WRITTEN AND THEY WERE QUITE RESPONSIVE TO QUESTIONS THAT WERE POSED BACK FROM THE NIH. SO THE INITIAL CONSENT IS A FARLY SHORT ONE INDICATING THAT FOLKS ARE NO LONGER INTERESTED IN RETAINING OR USING THOSE EMBRYOS FOR CLINICAL PURPOSES. SECOND FORM MUCH MORE DETAILED, BUT IN GOOD PLAIN LANGUAGE ABOUT STEM CELL RESEARCH, AND THEN THE THIRD THE CONSENT TO USE EMBRYO FOR THE [INDISCERNIBLE] OF STEM CELLS. WE THOUGHT THE CONSENT PROCESS WAS EXCELLENT WITH THE QUESTION OF EXCULPATORY POSSIBILITY OF EXCULPATORY LANGUAGE. WE LOOKED THAT LANGUAGE AND THIS HAD TO DO WITH INFORMATION AB WHETHER THERE WOULD BE ANY FINANCIAL RETURNS TO INDIVIDUALS BY VIRTUE OF COMMERCIALIZATION OR USE OF THE DERIVATION OR THE LINES THEMSELVES. THIS LANGUAGE THAT WAS IN THEIR DOCUMENT HOWEVER WAS QUITE SIMILAR TO LANGUAGE THAT HAS BEEN APPROVED FROM ACD PREVIOUSLY FROM NEW SOUTH WALES SUBMISSION. OUR ANALYSIS WAS THAT THE LANGUAGE WAS PRETTY STRAIGHTFORWARD INTENDING TO LET OWNERS KNOW THEY WOULD NOT BENEFIT FINANCIALLY FROM THE RESEARCH. WE DID NOT FEEL THE LANGUAGE WAS EXCULPATORY, AND SO OUR FINDING UNANIMOUSLY WAS TO SUGGEST THAT THE ACD RECOMMEND APPROVAL OF THESE LINES FOR USE IN NIH-FUNDED RESEARCH. SO WE MOVE ON TO THE GWANJU AND COME BACK TO THAT INITIAL APPLICATION IF THERE ARE QUESTIONS AFTER THIS PRESENTATION. THIS ONE'S MORE DETAILED. WE INITIALLY DID A PRESENTATION HERE TO THE ACD ABOUT A YEAR AGO, AND HAVE SPENT QUITE A BIT OF TIME ON THIS ONE. TOTAL OF ABOUT EIGHT MEETINGS AT WHICH THIS APPLICATION WAS DISCUSSED. CERTAINLY THE MOST THOROUGHLY EVALUATED APPLICATION IN OUR HISTORY FOR THE WORKING GROUP. THIS RELATES TO SIX LINES FROM EMBRYO DONATED 2007. THESE ARE SO-CALLED NON-CLINICAL GRADE EMBRYOS, NOT USER FOR FERTILITY TREATMENTS. MANY OF YOU HAVE HEARD SOME OF THOSE BASIC FACTS BUT AISLE REVIEW AT THIS POINT. THIS EMBRYO DONATION CONSENT WAS SIGNED AT THE SAME TIME AS THE IVF CONSENT. I'LL COME BACK TO THESE BRIEFLY WITH MY COMMENTS. THERE WAS ONGOING APPROVAL AND MONITORING BY THE HOSPITAL INSTITUTIONAL REVIEW BOARD, AND IN OUR DISCUSSION, THE WORKING GROUP NOTED THAT COUPLES MAY HAVE LIMITED OPTIONS WITH RESPECT TO CLINICAL GRADE EMBRYOS IN CHINA DUE TO THE ONE CHILD POLICY. THERE ARE OPTIONS TO USE ADDITIONAL STORED EMBRYOS MAY BE LIMITED IF AN INITIAL PREGNANCY, FOR EXAMPLE, IS INITIATED AND SUCCESSFUL. HOWEVER, ULTIMATELY, THE DETERMINATION OF THE MAJORITY OF THE GROUP AT LEAST WAS THAT THIS WAS NOT A RELEVANT ISSUE FOR THESE LINES BECAUSE THESE WERE NOT CLINICAL GRADE EMBRYOS. I'LL TOUCH MORE ON THAT HERE IN A MINUTE. WE THOUGHT IT WAS REASONABLE TO AGREE TO DONATE NON-CLINICAL GRADE EMBRYOS IN ADVANCE OF TREATMENT. SO PART OF THE CONCERN IN OTHER CONTEXT MIGHT BE YOU DON'T WANT FOLKS TO MAKE A COMMITMENT TO RESEARCH DONATION PRIOR TO THE TIME THAT THEY KNOW WHAT THE SUCCESS IS OF THE CURRENT IN VITRO EFFORT. IN THIS CONTEXT, SINCE WE'RE REFERRING TO SO-CALLED NON-CLINICAL GRADE EMBRYOS, WE THOUGHT IT WAS APPROPRIATE TO OBTAIN ADVANCED CONSENT OR CON SENT IN ADVANCE OF THE TREATMENT -- CONSENT IN ADVANCE OF THE TREATMENT, ITSELF. WE ALSO FOUND THE DONATION RATE FOR EMBRYOS IS ABOUT 7-8% IN THE CHINESE CULTURAL CONTEXT. ONE OF THE QUESTIONS WE HAD WAS IN THAT CONTEXT MIGHT THERE BE SOCIAL, CULTURAL PRESSURES TO DONATE? I THINK THIS DONATION RATE WAS REASSURING TO US THAT DID NOT SEEM TO BE ANY PROBLEMS WITH THE VOLUNTARINESS OF DECISIONS IN THAT CONTEXT. THERE WERE PROBLEMATIC STATEMENTS IN THE IVF TREATMENTS CONSENT. THERE'S A STATEMENT ABOUT WHAT HAPPENS WITH THE POSSIBILITY OF MULTIFETAL PREGNANCY. SO IF THERE ARE MORE THAN TWO FEAT FETUSES, THE CONSENT FORM EXPLICITLY STATES THAT THERE WILL BE FETAL REDUCTION THAT WOULD OCCUR. THAT WOULD NOT BE AN ACCEPTABLE PROVISION WITHIN THE U.S. CONTEXT. THE KEY ISSUE THAT BROUGHT THIS BACK FOR FURTHER DISCUSSION AND FURTHER DISCUSSION TODAY IS COMPETING TRANSLATIONS OF KEY TERMS IN THE DOCUMENT, THE SUBJECTS ACKNOWLEDGMENT WHICH IS REALLY THE CONSENT FORM. PROVIDED A TRANSLATION THAT SAYS THE DISCARDED EMBRYOS CANNOT BE AVAILABLE TO ANY INDIVIDUAL OR RESEARCH UNITS WITHOUT OUR CONSENT. THE DISCARDED EMBRYOS CAN NOT BE USED TO OTHER EXPERIMENT WITHOUT OUR CONSENT. POINT HERE BEING THAT THEY'RE DONATING THESE FOR EMBRYONIC STEM CELL RESEARCH AND IF THE INSTITUTION HAD AN INTEREST IN DOING SOMETHING OTHER THAN THAT, THEN THE IMPLICATION WOULD BE THAT THEY WOULD GET BACK TO THE DONORS FOR CONSENT. THE NIH TRANSLATION OF THE ORIGINAL MANDARIN FORM SAYS THE SPECIMENS MAY NOT BE PROVIDED TO ANY INDIVIDUAL OR RESEARCH INSTITUTION WITHOUT OUR CONSENT, THE SPECIMENS WAY MAY NOT BE USED IN ANY OTHER TEST IN THE LABORATORY WITHOUT OUR CONSENT. THE QUESTION FOR US AND FOR THE ACD WITH YOUR DISCUSSION WAS, WHAT DO PEOPLE UNDERSTAND WITH THIS TERMINOLOGY OF SPECIMEN? DO THEY UNDERSTAND THAT IT'S THE EMBRYO THAT'S BEING REFERRED TO OR MIGHT THEY UNDERSTAND THAT TO MEAN THE STEM CELLS THAT HAVE BEEN DERIVED AND THAT THERE WOULD BE RESTRICTIONS ON THE DISTRIBUTION OF THE STEM CELLS, THEMSELVES? SO WE CONSIDERED THIS ISSUE AND I THINK THE WORKING GROUP, AT LEAST THE MAJORITY FELT THAT WHILE THERE WAS SOME AMBIGUITY THERE, THAT IN THE LARGER CONTEXT OF THE CONSENT FORM, FOLKS WOULD UNDERSTAND THAT IT WAS THE EMBRYO BEING REFERRED TO IN THAT CONTEXT. BUT AFTER DISCUSSION HERE, THE ACD WAS NOT OF THE SAME OPINION. THERE WAS A CONCERN ABOUT THAT AMBIGUITY AND WHAT DID FOLKS REALLY UNDERSTAND ABOUT THIS IMPORTANT QUESTION IN THE CONSENT PROCESS? THEY ASKED US TO RETURN TO THIS ISSUE AND THINK MORE AND WORK A LITTLE BIT HARDER ON THIS PARTICULAR RECOMMENDATION. SO WE CONSULTED FOUR OUTSIDE INDIVIDUALS AND EXPERTS WHO ARE FLUENT IN CHINESE LANGUAGE, FAMILIAR WITH THE CULTURE, KNOWLEDGEABLE ABOUT IVF PRACTICES IN THAT CONTEXT AND ALSO INDIVIDUAL WHO IS DON'T HAVE ANY ASSOCIATION WITH THE G WSHG ANJU MEDICAL CENTER. GWANJU. OF THESE FOUR REVIEWERS, UM, ALL AGREED THAT THE NIH TRANSLATION WAS THE MOST, WAS THE ACCURATE TRANSLATION AND THAT THE SUBMITTED TRANSLATION FROM THE APPLICANT USING THE TERM EMBRYO WAS NOT AS ACCURATE. TWO REVIEWERS WERE FAIRLY STRAIGHTFORWARD SAYING THE LANGUAGE IN SHARING CELL LINES WITH INVESTIGATORS AT OUTSIDE INSTITUTIONS. TWO REVIEWERS ALSO FELT THAT THE OVERALL CONSENT FORM WAS AMBIGUOUS AND INADEQUATE, AGAIN, SPECIFICALLY BECAUSE OF THAT AMBIGUITY. THE OTHER TWO IN EACH OF THESE SORTS OF QUESTIONS WERE A LITTLE BIT LESS CLEAR EXACTLY HOW THEY WERE RESPONDING TO OUR PROMPTS. WE SENT THEM A WRITTEN SURVEY FORM THAT WE GOT, LONG FORM ANSWERS TO FROM THEM. SO I THINK WITH THIS ADDITIONAL FEEDBACK, WE COULD NOT BE CERTAIN THAT COUPLES WHO WERE DONATED THEIR EMBRYOS HAD AN ADEQUATE UNDERSTANDING OF WHAT THE PROCESS WAS WITH THE MANAGEMENT OF THE STEM CELLS BEING DERIVED FROM THEIR LINES, SO WE THOUGHT THAT THIS AMBIGUITY IN THIS CRITICAL PART OF THE CONSENT FORM WAS IMPORTANT. SO AFTER# DISCUSSION, WE VOTED UNANIMOUSLY TO PRESENT A NEGATIVE FINDING NOW TO YOU TODAY ON THE GWANJU APPLICATION. SO HERE'S A QUICK SUMMARY OF OUR PRESENTATIONS TODAY. ACD SHOULD CONSIDER RECOMMENDING THAT FOUR LINES FROM THE UNIVERSITY OF QUEENSLAND, AUSTRALIA BE APPROVED FOR USE, NIH-FUNDED SUPPORTER RESEARCH, BUT ACD SHOULD CONSIDER RECOMMENDING THAT THE SIX LINES FROM GWANJU MEDICAL COLLEGE BE DISAPPROVED FOR USE IN NIH-SUPPORTED RESEARCH. >> JEFF, THANK YOU VERY MUCH FOR PRESENTING THOSE FINDINGS AND LET ME ASK WHETHER ACD MEMBERS WOULD LIKE TO ASK QUESTIONS. BOB. >> I'M JUST WONDERING WHAT THE LANGUAGE WAS IN THE QUEENSLAND ISSUE. >> YES, I HAVE THAT AND I'LL READ THAT FOR YOU. SO THIS IS A QUOTE FROM THE CONSENT FORM. EXCESS EMBRYOS MUST BE DONATED ALTRUISTICALLY FOR THE PROJECT WHILE NO COMMERCIAL GAINS WILL RESULT FROM THE DERIVATION OF EMBRYONIC STEM CELL LINES OR ES LINES IT SAYS, THE EMBRYO DONORS WILL HAVE NO CLAIM NOW OR IN THE FUTURE ON ANY FINANCIAL BENEFITS THAT MAY BE GENERATED FROM THE USE OF THESE CELL LINES. >> MARIA. >> WOULD YOU REMIND ME IF YOU GIVE FEEDBACK TO [LOW AUDIO] THE CELL LINES OF THE FINDINGS AND WHY YOU COME TO THAT CONCLUSION [LOW AUDIO]? >> UM, THE NIH IS THE INTERFACE BETWEEN THE WORKING GROUP AND THE APPLICANTS. THEY'RE NOT INFORMED OF OUR FINDINGS UNTIL THIS PARTICULAR PRESENTATION, BUT THERE'S QUITE A BIT OF DIALOGUE BACK AND FORTH TO CLARIFY POINTS ALONG THE WAY. >> SO THE FEEDBACK THAT THEY WOULD RECEIVE, UM, IS THROUGH THE MATERIALS THAT ARE PRESENTED TO THIS GROUP? THEY HAVE ACCESS THROUGH THE, UM, WEB SITE FOR THOSE MATERIALS. WE DO NOT, FOR EXAMPLE, SUGGEST HOW IN THE FUTURE THOSE FORMS COULD BE -- THEY CAN GO AND LOOK AT APPROVED FORMS THAT HAVE GONE THROUGH HERE, SO, UM, WE DON'T DIRECT THEM BUT THEY HAVE THE MATERIALS AT HAND TO SEE WHAT IS -- WHAT'S RECOMMENDED, WHAT THE FINDINGS ARE FOR LINES TO GO FORWARD AND THE FINDINGS FOR LINES THAT DO NOT GO FORWARD. >> IT SOUNDS LIKE THE CONSENTING PROCESS IS THE MOST IMPORTANT ONE. WHY NOT TAKE THE NEXT STEP AND MAKE A STANDARDIZED CONSENT FORM THAT COULD BE READILY AVAILABLE FOR TRANSLATION AND OTHER PLACES SO THAT THAT HURDLE COULD BE A LITTLE BIT EASIER TO GO THROUGH? IT SEEMS LIKE IT'S ALL ABOUT THE CONSENT FORM EVERY TIME THAT WE'VE MET. ANOTHER QUESTION I WANT TO SAY, CAN THE [INDISCERNIBLE] PROJECT K THEY GO BACK AND RECONSENT, OR IS THAT LIKE OVER AND SAID FOR? >> SO, UM, THE ACD WORKING GROUP IS ONLY SEEING OLDER LINES THAT WERE GENERATED BEFORE THE NEW GUIDELINES WERE PUT IN PLACE. SO THE NEW GUIDELINES ARE QUITE SPECIFIC ABOUT WHAT HAS TO BE IN THE CONSENT FORM, AND SO AFTER JOULE 7th, 2009 -- JULY 7TH, 2009, NO AMERICAN DONATED EMBRYOS WILL GO THROUGH THE ACD, AND OUR PERCEPTION IS THAT AS THE DONATION OF EMBRYOS IN CREATION OF HUMAN EMBRYONIC STEM CELL LINES PROGRESSED FROM 1998 TO -2-005-2008, UM, RECOGNITION OF WHAT NEEDED TO BE IN THOSE CONSENT FORMS BECAME MUCH CLEARER. SO YOU ARE SEEING A SUBSET OF OLDER LINES, UM, AND, UM, THE SECOND QUESTION WAS -- >> WAS CAN WE GO BACK AND RECONSENT? >> IN PRINCIPLE, THEY COULD, AND THEN WOULD RESUBMIT. THAT WAS DISCUSSED WITH RESPECT TO THE VERLINSKY LINES FROM UNIVERSITY OF CHICAGO, WHICH WAS ANOTHER SET OF LINES THAT CAME THROUGH HERE. >> SO THE LINES THAT GO THROUGH FOR ADMINISTRATIVE REVIEW GO ACROSS MY DESK BEFORE THEY GO TO FRANCIS AND IT SEEMS TO ME BECAUSE OF THE CLARITY OF THE GUIDELINES AND BECAUSE OF EXPERIENCE THAT WE DON'T REALLY NEED A MODEL CONSENT BECAUSE EVERYBODY REALLY HAS SORT OF ADOPTED VERY SIMILAR LANGUAGE, SO I THINK THERE'S A UNIFORM PRACTICE THAT'S EMERGING. >> IT'S THE LEGACY LINES. >> HOW MANY WERE REJECTED? IT SEEMED LIKE A LOT WERE REJECTED WITH 95. ARE THOSE TYPICALLY BECAUSE OF CONSENTING? >> SO IT'S 59 THERE WERE REJECTED, AND IT NOW IT'LL BE UP TO 65 -- >> DEPENDING ON WHETHER -- >> DEPENDING ON WHAT THE DIRECTOR'S DECISION IS. SORRY, I DIDN'T MEAN TO PRESUME -- [LAUGHTER] I'M SORRY, I'M SORRY, OH MY GOD -- 59, AND THOSE ALL CAME FROM, UM, ONE PLACE WHERE THE CONSENT WAS, UM, RIGHT -- >> COUPLE OF COMMENTS. I'M VERY IMPRESSED WITH THE THOROUGHNESS AND I'M COMFORTABLE WITH THESE RECOMMENDATIONS FOR THE REASONS STATED. I DO FIND IT ODD, HOWEVER, THAT THE PEOPLE ACTUALLY ON SIGHT IN GWANJU WOULD HAVE A DIFFERENT UNDERSTANDING OF THE WORDS THAT THEY WERE USING COMPARED TO OUR INDEPENDENT EXPERTS. NOW, WE ARE THE BENEFICIARIES OF PROBABLY THE LEAST PRECISE LANGUAGE ON THE PLANET, ENGLISH. [LAUGHTER] THE CHANCE FOR AMBIGUITY IS JUST REMARKABLE. I DON'T KNOW ABOUT CHINESE, BUT COULD THIS JUST BE A DIFFERENT UNDERSTANDING OF THE WORD? >> JEFF, YOU HAD THE CHINESE LANGUAGE SPEAKERS TRY TO ADDRESS THAT; WHAT DO YOU THINK? >> YEAH. HONESTLY, I WOULDN'T KNOW HOW TO ADEQUATELY RESPOND TO THAT. IT MAY BE THAT THEY WERE PROVIDING US WITH AN INTERPRETATION OF WHAT THEY MEANT TO SAY AS OPPOSED TO WHAT A MORE TECHNICAL OR INDEPENDENT READING OF THE FORM ACTUALLY DOES SAY. I THINK THAT WAS PROBABLY OUR ASSUMPTI ASSUMPTION IN GOING INTO THE FORM TO BEGIN WITH. THAT'S WHAT THEY WANTED PEOPLE TO BELIEVE EVEN THOUGH THE LANGUAGE, PERHAPS, DIDN'T SUPPORT IT. >> I MEAN, NOT TO MAKE TOO LIGHT OF THIS, BUT IN CHINESE, YOU'RE LOOKING AT LITTLE PICTURE -- [LAUGHTER] -- YOU CAN'T SPELL IT OUT. >> JEFF. >> I THINK ACTUALLY THAT WAS ONE OF THE MOST VALUABLE LESSONS THAT WE TOOK AWAY FROM THIS IS THAT BOTH THE CULTURAL DIFFERENCES, THE EARLIER ISSUE JEFF EXPRESSED THE POINT ON IN TERMS OF THE REDUCTION OF THE MULTIFETAL PREGNANCIES AND THEN THE LANGUAGE DIFFERENCES. OTHER PEOPLE IN THIS ROOM THAT ARE FLUENT IN TWO OR MORE LANGUAGES, IT SOMETIMES IS HARD TO MAKE THAT EXACT TRANSLATION. SO I DON'T THINK IT'S NECESSARILY ANYTHING NEFARIOUS THAT WAS BEING DONE AT THE OTHER END BUT THERE ARE DIFFERENT WAYS PEOPLE SEE THINGS AND IT WAS A DIFFERENT POPULATION. WE JUST HAVE TO BE SENSITIVE TO THAT, AND PROBABLY EVEN WITHIN THE U.S.,EN IF ENGLISH IS TREATED AS A STANDARD LANGUAGE, CULTURAL DIFFERENCES CAN BRING UP WAYS THAT PEOPLE INTERPRET THINGS DIFFERENTLY AAS WELL. >> AND AS I UNDERSTOOD, THE TASK YOU ASSIGNED TO YOUR FOUR EXPERTS WAS TO TRY TO ASK THEM WHAT WOULD THE COUPLES HAVE ASSUMED WAS MEANT BY THE LANGUAGE, NOT NECESSARILY WHAT DID THE INVESTIGATORS THINK THEY MEANT, BUT WHAT WOULD COUPLES HAVE NORMALLY TAKEN THESE WORDS TO MEAN? >> YES. THAT'S RIGHT. WHAT WE WANTED TO DO AS WE GOT BACK TO THESE OUTSIDE INDIVIDUALS IS NOT SIMPLY FOCUS ON THAT HOW WOULD YOU INTERPRET THAT WORD, BUT HOW DO YOU UNDERSTAND THIS LARGER FORM? HOW DO YOU UNDERSTAND THESE TERMS IN THE CONTEXT OF THE LARGER FORM, ITSELF? FOLKS WERE VERY THOUGHTFUL WITH THEIR FEEDBACK FOR US. >> I'D LIKE TO MOVE THAT WE ACCEPT THE REPORT. >> ANY FURTHER DISCUSSION? ALL IN FAVOR? ANY O OWE OPPOSED? THANK YOU, THAT HAS BEEN TAKEN AS A RECOMMENDATION TO ME IN BOTH CASES; THE UNIVERSITY OF QUEENSLAND AND THE GWANJU MEDICAL COLLEGE. I'LL TAKE THAT UNDER ADVISEMENT AND MAKE A DECISION IN THE NEAR FUTURE. JEFF, THANK YOU AGAIN. VERY INSTRUCTIVE. GLAD WE BROUGHT YOU BACK A YEAR LATER. [LAUGHTER] I THINK THE FACTS WOULD SHOW THAT THIS WAS WELL WORTH THE EXPLORATION. I THINK AT THIS POINT WE HAVE COME TO THE END OF THE STATED AGENDA, AND EVEN DONE SO LITTLE AHEAD OF SCHEDULE WHICH IS TO THE CREDIT OF EVERYONE IN THE ROOM. I DON'T KNOW IF THERE'S ANY COMMENTS THAT ANYBODY WOULD LIKE TO MAKE BEFORE WE MOVE TOWARDS ADJOURNMENT; ARE THERE ANY FINAL THOUGHTS, BEE? >> I THINK THERE'S BEEN THIS BIG STEAM ABOUT GENOMICS AND WHAT KEPT COMING UP TO ME, ESPECIALLY AFTER HEARING ABOUT THE CANCER INSTITUTE IS, UM, IS THERE A [INDISCERNIBLE] ORGANIZED SUPPORT OF THE HUE MUNGS AMOUNT OF DATA EVEN WITH CHECKING IN WITH COMING IN IS A VERY HIGH QUALITY THAT EVERYBODY THAT PUBLIC ACCESS -- YOU KNOW ALL THOSE QUESTIONS THAT COME UP BECAUSE AGAIN, HISTORICALLY THIS IS HUGE, AND NOW THAT I'M SEEING EVERYONE HAS CAN BE INFORMED WITH THIS, I'M WONDERING IF THERE'S A REAL, LIKE FOCUSED EFFORT [LOW AUDIO]? >> I THINK IT'S FAIR TO SAY THERE IS AND THE CHALLENGE IS HUGE AND THE BOUNDARIES ARE HARD TO DEFINE BECAUSE GENOMICS HAS INVADED SO MANY AREAS ACROSS WHAT MEDICAL RESEARCH IS ALL ABOUT. CERTAINLY, WHEN IT COMES TO THE CANCER AREA THAT HAROLD WAS TALKING ABOUT, A GREAT DEAL OF EFFORT GOING INTO GENERATED PUBLIC DATABASES FROM THAT CANCER GENOME ATLAS. CERTAINLY THE NATIONAL HUMAN GENOME RESEARCH INSTITUTE SPENDS A LOT OF THEIR EFFORTS IN TERMS OF DNA SEQUENCES MAKING SURE THAT THE DATA IS HIGH-QUALITY AND IT'S READILY ACCESSIBLE FOR ANALYSIS, THAT THERE IS AN OPENNESS TO NEW ANALYSES OF THE DATA BY PEOPLE WITH NEW ALGORITHMS. I THINK FOR THOSE BIG COMMUNITY-ORIENTED PROJECTS THAT THE SITUATION IS ACTUALLY QUITE GOOD. SIMILARLY, FOR GENOME-WIDE ASSOCIATION STUDIES THE AVAILABILITY OF THE DB GAP DATABASE AND THE WAY IN WHICH THAT WAS ESTABLISHED AND IS CURE RATED AND MAINTAINED HAS BEEN A WONDERFUL BOON IN TERMS OF BEING ABLE TO KNOW THAT YOU'RE LOOKING AT HIGH-QUALITY RESULTS THAT AREN'T GOING TO BE HERE TODAY AND GONE TOMORROW. THERE ARE OTHER AREAS IN TERMS OF LOOKING AT THE EPI GENOME THAT HAVE ALSO SPAWN LARGE BAYDAY -- DATABASE EFFORTS -- WHICH MIGHT BE MORE LOG THAN DIGITAL IS IN FACT OF HIGH ENOUGH QUALITY TO PUT IT OUT THERE, AND I THINK A LOT OF ATTENTION BEING PAID TO THAT AGAIN FOR THE LARGE-SCALE COMMUNITY-BASED PRODUCTS WHERE THERE'S A LOT OF CAREFUL THOUGHT ABOUT PRODUCT MANAGEMENT. PROBABLY LESS IN THE WAY OF OVERSIGHT OF SMALLER PROJECTS CONDUCTED BY INDIVIDUAL INVESTIGATORS, BUT STILL A VERY STRONG INTEREST IN CAPTURING THAT DATA INTO THE PUBLIC DATABASES THAT ARE POP RATED, FOR INSTANCE, BY -- OPERATED BY NCBI. WE TALKED YESTERDAY ABOUT THE WHOLE PROBLEM OF BIG DATA AND WHAT IS NIH DOING TO IDENTIFY BOTH THE POP -- POLICIES AND HOW TO IMPLEMENT THEM. THAT'S A BIG CHALLENGE BOTH FOR EXTERNAL GROUP THAT DAVID AND LARRY ARE OVERSEEING AND FOR A LOT OF INTERNAL DISCUSSIONS AS WELL. YOU'RE RIGHT TO POINT TO IT AS A PROBLEM THAT IS CHALLENGING NOW AND IS ONLY GOING GET MORE SO AS WE RIDE THIS EXPONENTIAL CURVE OF DATA PRODUCTION, WHICH IS BREATH TAKING IN -- >> [LOW AUDIO]. >> IT IS A GREAT CHALLENGE. IT'S A A GOOD PROBLEM TO HAVE. I REMEMBER WHEN WE USED TO WORRY ABOUT, WILL WE EVER HAVE ENOUGH DATA TO HAVE THIS BE AN INTERESTING PROBLEM, WELL, BE CAREFUL WHAT YOU WISH FOR. >> [LOW AUDIO]. >> FRANCIS, IS IT POSSIBLE TO HAVE -- I DON'T KNOW IF THE RULES ALLOW TWO MINUTES OR SO WITHOUT EXECUTIVE SESSION -- IS THERE NO SUCH THING? >> I THINK WE HAVE TO ANNOUNCE IT IN ADVANCE IN THE FEDERAL REGISTER FOR THAT TO BE THE CASE. >> I'LL ASK MY QUESTION OFFLINE. >> ALL RIGHT. [LAUGHTER] WELL, IF THERE ARE NO OTHER COMMENTS, I WANT TO THANK, AGAIN, THIS WONDERFUL GROUP OF WISE, THOUGHTFUL, G-SHAPED PEOPLE -- [LAUGHTER] -- FOR THE WAY IN WHICH YOU ONCE AGAIN -- I'M GOING TO HANG ON NO TO THAT ONE. >> [LOW AUDILO[LOW AUDIO] I SAID IT BEFORE IT'S THE [LOW AUDIO] I ALSO THINK IT'S FANTASTIC IMAGE. >> IT IS INDEED AND YOU ALL FIT THAT DEFINITION BEAUTIFULLY. THANK YOU. WE WILL SEE YOU AGAIN IN JUNE AND WE'LL PROBABLY BE IN TOUCH MULTIPLE TIMES IN-BETWEEN. >> THANKS TO THE STAFF. THE STAFF SUPPORT FOR THIS MEETING IS OUTSTANDING, AROUND THE STAFF PEOPLE ARE BEING ACTUALLY NOT PAYING ATTENTION, SO -- [LAUGHTER] -- WOULD YOU GET YOUR CREDIT IS CREDIT DUE, THE STAFF WORK ON THIS IS GREAT. >> ABSOLUTELY. [APPLAUSE] WELL SAID. WITH THAT -- YEAH, WHO'S COOKING IN JUNE IS THE NEXT QUESTION; WE SHALL SEE. [LAUGHTER]