>> GOOD AFTERNOON, EVERYONE. WELCOME TO THE NATIONAL CHILDREN'S STUDY VIDEOCAST, WHICH IS DIRECTED TO PEOPLE ALL ACROSS AMERICA, PARTICULARLY THOSE IN COMMUNITY ADVISORY BOARDS AND WHO HAVE SERVED THE NATIONAL CHILDREN'S STUDY SO EXCELLENTLY AND SO FAITHFULLY FOR THE PAST MANY YEARS. AND WE WANTED TO HAVE AN OPPORTUNITY FOR YOU TO HAVE YOUR OWN SEGMENT, WHICH IS OTHERWISE TECHNICALLY A CLOSED MEETING BECAUSE IT'S A MEETING BETWEEN THE FEDERAL GOVERNMENT AND ITS CONTRACTORS. BUT WE HAVE THE OPTION, AND WANTED TO TAKE ADVANTAGE OF THAT OPTION TO OPEN UP PARTS OF THE MEETING. SO, FOR THE NEXT 90 MINUTES OR SO, YOU WILL MEET SOME VERY INTERESTING AND EQUALLY DEAD TATED -- DEDICATED PEOPLE ON THE PODIUM HERE AND ON THE STAGE WHO HAVE VARIOUS CAPACITIES AND ROLES IN THE STUDY, AND THEN WE'LL REVIEW OUR GENERAL PROCEDURES AND TAKE QUESTIONS. PRIMARILY WE WOULD LIKE TO TAKE THE OPPORTUNITY TO BE RESPONSIVE AS WE CAN, AND ALSO BE ASSURED AND ASSURE YOU THAT WE ARE COMMUNICATING OUR PRIORITIES AND OUR GOALS. FOR TECHNICAL REASONS, WE NEED TO TAKE QUESTIONS BY E-MAIL. SO, IF YOU'D LIKE TO SUBMIT A QUESTION ON THE SCREEN BEHIND ME, I BELIEVE, IS AN E-MAIL ADDRESS, TJOHNSON@CIRCLE SELECTIONS.com. WE ALREADY HAVE SOME QUESTIONS, AND WE LOOK FORWARD TO PRESENTING THEM TO OUR INTERESTING AND COOPERATING PANEL. SO LET'S BEGIN WITH YOU, EVERYONE SAY WHO YOU ARE, WHERE YOU'RE FROM, AND A LITTLE ABOUT YOURSELF, AND THEN WE'LL GO AROUND TO THE PROGRAM OFFICE STAFF. >> THANK YOU VERY MUCH. MY NAME IS CARRIE EILLERS AND I'M RUN OF THE REPRESENTATIVES FOR OVER A YEAR AND A HALF NOW. >> MY NAME IS TIM. I'M THE PRESIDENT OF THE UNITEES WAY OF CENTRAL MASSACHUSETTS. LOVE THE JOB, AND AM THRILLED TO BE A NATIONAL COMMUNITY REPRESENTATIVE AND ABSOLUTELY LOVE THE MISSION OF THIS, OF THE NATIONAL CHILDREN'S STUDY, WE'RE WE'RE WORKING TO IMPROVE THE HEALTH OWL OF OF AMERICA'S CHILDREN. >> GOOD AFTERNOON, MY NAME IS -- GOOD AFTERNOON. MY NAME IS CLARENCE JONES. I AM OUTREACH DIRECTOR FOUR THE SOUTH SIDE OUTREACH IN MINNESOTA. I'M THE CO-CHAIR OF OUR LOCAL BOARD, AS WELL AS A STUDENT AT THE UNIVERSITY OF MINNESOTA IN THE SCHOOL OF PUBLIC HEALTH AND CHILD HEALTH. >> I AM STEVE WITH THE COMMUNITY ENDEAVORS FOUNDATION IN CLEVELAND, OHIO, AND AT OUR FOUNDATION WE DEVELOP AND PROMOTE PROGRAMS FOR LOW INCOME FATHERS OVER WHAT WE CALL THE LIFE SPAN OF FATHERHOOD, BEGINNING FRIF BLESS 0 WHO ARE NOT YET FATHERS UP TO MENTORS. >> I AUTOMATIC OF THE COMMUNITY REPRESENTATIVES AND I'M A CONSULTANT FOCUSED ON YOUTH AND COMMUNITY ENGAGE INSIDE SACRAMENTO, CALIFORNIA, AND I FOCUS ON YOUTH VIOLENCE PREVENTION FOR A NONPROFIT AGENCY THAT IS WORKING TOWARD ALLEVIATING DOMESTIC AND SEXUAL ASSAULT. >> HI. I'M ROBILEE STANTON AND I'M A NURSE CONSUL STAND FOR THE STATE OF ILLINOIS AND I WORK WITH LOCAL HEALTH DEPARTMENT AGENCIES IN SOUTHERN ILLINOIS, AND I HAVE BEEN A COMMUNITY REPRESENTATIVE FOR A YEAR AND A HALF ALSO, AND I'M A MAYBE OF A GROUP OF THREE COUNTIES THAT HAVE NOT YET BEGUN RECRUITMENT FOR THE NATIONAL CHILDREN'S STUDY, SOUNDS LIKE WITH ALL THE CHANGES COMING I'M UNSHIRE IF THEY WILL AGAIN RECRUIT INDEPENDENT OUR COMMUNITY, BUT I'M AFAILATED WITH THE GATE WEAR STUDY THE IN ST. LOUIS. >> SUCH A WELL QUALITY GROUP OF COMMUNITY REPRESENTATIVES. >> I'M IN THE PROGRAM OFFICE. HAPPY TO BE HERE. I WORKED SOME WITH THE COMMUNITY REPRESENTATIVE GROUP AND EXCITED TO CONTINUE TO HELP OUT. >> GOOD AFTERNOON. MARIA LOPEZ CLARENCE, AND I ALSO WORK WITH THE COMMUNITY NATIONAL REPRESENTATIVES GROUP AND THEY BRING A VERY NICE PERSPECTIVE ON HOW WE COULD FURTHER IMPROVE THE STUDY. THANK YOU. >> HOME JOHN LOVEKIN, A PROJECT MANAGER FOR THE STUDY CENTERS, AND ALSO A MEMBER OF THE DATA ACCESS TEAM FOR THE PROGRAM OFFICE. >> GOOD AFTERNOON. I'M KATE, A PROJECT OFFICER AND WORK ON COMMUNICATIONS AND COMMUNITY OUTREACH IN THE PROGRAM OFFICE. >> GOOD AFTERNOON. MY NAME IS -- I'M WORK WITH SEVERAL OF THE STUDY CENTERS AND WORK WITH KATE. NICE TO BE HERE. THANK YOU. >> THANK YOU ALL. I'LL BEGIN BY EXPLAINING A LITTLE BIT OF THE BUSINESS STRUCTURE SO THAT EVEN THOUGH DR. HILL SAID WHAT A COTAR, CONTRACT OFFICE REPRESENTATIVE, SMOOTH NOT RESONATE EVERY WINCH. THE NATIONAL CHILDREN'S STUDY IS FUNDED BY THE U.S. CONGRESS WITH A LINE ITEM APPROPRIATION. THAT MEANS THE CONGRESS GIVES US, OUT OF THE ANNUAL BUDGET, MONEY SO THAT WE CAN PERFORM OUR ACTIVITIES AND THAT MONEY IS PASSED THROUGH THE OFFICE OF THE NATIONAL INSTITUTES OF HEALTH DIRECTOR, AND THEN WE DISBURSE THAT MONEY TO CONTRACTORS, AND THAT MONEY DISBURSEMENT IS GUIDED BY OUR CRAG PROCESS WHERE WE PUT OUT ADVERTISEMENTS AND SAY, WE NEED WORK DONE, AND IN THIS CASE THE WORK INVOLVES RECRUITING, RETAINING, FAMILIES AND COLLECTING DATA FOR THE NATIONAL CHILDREN'S STUDY, BUT THERE ARE ALSO MANY OTHER TASKS ASSOCIATED WITH THE NATIONAL CHILDRENS STUDY THAT INCLUDE LOGISTICS AND TRAINING AND A VARIETY OF SUPPORT FUNCTIONS. EVERY ONE OF THESE CONTRACTS IS AN OPEN COMPETITION, WHICH MEANS THAT ANYONE WHO IS QUALIFIED CAN APPLY, AND THEN AN INDEPENDENT PANEL REVIEWS THE APPLICATIONS AND SCORES THEM. THEN WE IN THE FEDERAL GOVERNMENT GET THE RESULTS OF THAT REVIEW, AND IT'S EXCEEDINGLY RARE THAT TWO APPLICANTS HAVE THE SAME SCORES SO THERE'S USUALLY APPLICANTS THAT HAVE THE HIGHEST SCORES FOR A PARTICULAR CONTRACT, AND WE THEN GENERALLY ACCEPT THE RECOMMENDATIONS OF THAT REVIEW PANEL, AND BEGIN A PROCESS OF NEGOTIATION WITH THE APPLICANT WHO HAD THE BEST SCORES. THERE ARE ONLY SOME PEOPLE WHO ARE AUTHORIZED TO NEGOTIATE ON THE PART OF THE GOVERNMENT, AND ONLY SOME PEOPLE WHO ARE AUTHORIZED TO TRANSFER GOVERNMENT FUNDS TO OTHER PEOPLE. THEY HAVE TO BE QUALIFIED AND THEY HAVE WHAT IS CALLED A WARRANT -- WITHIN THE LARGER OFFICE OF ACQUISITIONS IN THE EWAN IS IN KENNEDY SHRIVER INSTITUTE OF CHILD DEVELOPMENT. THE PEOPLE WHO HAVE THE AUTHORITY TO NEGOTIATE AND DISBURSE FUNDS ARE SPECIALISTS. THEY KNOW A LOT ABOUT LAW, REGULATION, FINANCE, BUT WHEN IT COMES TO RESEARCH CONTRACTS CAN WE HAVE TO WORK AS A TEAM BECAUSE THE RESEARCH ALMOST ALWAYS INVOLVES AN UNDERSTANDING OF THE TECHNICAL AND SCIENTIFIC ASPECTS OF THE TASK. AND THAT'S WHERE THE FOLKS TO MY RIGHT COME IN, BECAUSE THEY ARE PART OF THE TEAM AND PROVIDE THE TECHNICAL, SCIENTIFIC, AND OVERSIGHT PERSPECTIVE TO WORK WITH THE CRAG -- CONTRACTING OFFICERS. THEY DON'T HAVE THE AUTHORITY TO NEGOTIATE OR DISBURSE FUNDS BUT THEY PROVIDE KEY ADVICE AND THEY FUNCTION AS ONE OF THE PRIMARY INTERFACES BETWEEN THE FEDERAL GOVERNMENT AND PEOPLE WHO ARE CONTRACTORS. EVERY CONTRACT IS FOR A DEFINED PERIOD OF PERFORMANCE. THERE ARE NO INFINITE CONTRACTS, AT LEAST NOT ANYMORE. MAYBE ABOUT ONE TIME THERE WERE. AND WHEN THE PERIOD OF PERFORMANCE IS COMPLETED FOR A CONTRACT, THEN THAT CONTRACT EXPIRES. AND OUR JOB IS TO BOTH MONITOR THE PERFORMANCE DURING THE PERIOD OF PERFORMANCE, BUT ALSO PLAN FOR CONTINUITY OF ACTIVITIES IF WE NEED CONTINUITY, WHEN THAT CONTRACT EXPIRES. SO, OUR PRESS IS THAT WE DEVELOP A NEW SET OF CRITERIA BECAUSE PARTICULARLY IN RESEARCH, THE JOB KEEPS CHANGING. THE EXPECTATIONS SHIFT, AND IN THE NATIONAL CHILDREN'S STUDY IN PARTICULAR, WE TAKE ON AN APPROACH WHERE WE SAY WE ARE DATA-DRIVEN, EVIDENCE-BASED, AND COMMUNITY-AND-PARTICIPANT INFORMED. SO OVER THE COURSE OF A TYPICAL CONTRACT, WHICH IS FIVE YEARS, THINGS CHANGE, AND WE REDRAFT THE NEW CONTRACTS TO ALIGN WITH WHAT WE HAVE LEARNED IN THE PRECEDING FIVE YEARS, AND ANTICIPATE THE WORK THAT WOULD BE DONE IN THE NEXT FIVE YEARS. SO, WE ARE IN THE MIDST OF SUCH A CYCLE RIGHT NOW, AND THAT IS WHY WE HAVE A PERIOD OF TRANSITION. NOW, EVERYONE THAT HAS A CONTRACT CAN COMPETE FOR A NEW CONTRACT, BUT WE ALSO NEED TO KEEP IT OPEN SO THAT OTHERS WHO MIGHT WANT THE OPPORTUNITY TO COMPETE FOR A CONTRACT, HAVE THAT OPPORTUNITY. AND THEN EVALUATIONS ARE MADE BY AN INDEPENDENT PANEL, AND THE PROCESS BEGINS AGAIN. THAT'S THE BUSINESS MODEL FOR THE NATIONAL CHILDREN'S STUDY. NOW, THE FOLKS ON MY RIGHT, WHO ARE CLOSER TO ME, ARE PART OF WHAT WE PUT TOGETHER AS ANOTHER GROUP OF ADVISORS WE FOUND WE HAD A GAP, IN THAT WE HAD COMMUNITY ADVISORY BOARDS THAT WERE ESTABLISHED ON A LOCAL LEVEL. BUT WE IN THE PROGRAM OFFICE, AND PARTICULARLY OUR COTART STAFF, DID NOT HAVE ANY MECHANISM TO DIRECTLY INTERACT WITH ANY OF THE PEOPLE ON THE COMMUNITY ADVISORY BOARDS, UNLESS WE HAPPENED TO TAKE A TRIP OUT TO THAT AREA AND IF THERE HAPPENED TO BE A MEETING SCHEDULED AND WE HAPPENED TO BE INVITED, THERE WAS NO MECHANISM WHERE WE COULD GET INPUT FROM PEOPLE IN THE COMMUNITIES WHO WERE IN WAYS AFFECTED OR INVOLVED WITH THE NATIONAL CHILDREN'S STUDY. SO, WE ESTABLISHED GROUP OF WHAT WE CALL NATIONAL COMMUNITY REPRESENTATIVES. THEY'RE NOT ALL HERE BUT MANY ARE. AND WE MEET WITH THEM TWICE A YEAR IN PERSON, AND MORE FREQUENTLY BY TELEPHONE. THE LEADS BETWEEN OUR STAFF AND THE GROUP OF NATIONAL COMMUNITY REPRESENTATIVES ARE DOCTORS MARIA LOPEZ CLASS AND CARL HILL. AND I, MYSELF, MAKE IT A POINT -- AND I USUALLY CONSIDER ONE OF THE HIGHLIGHTS OF THE OPPORTUNITY THAT WHEN THEY DO COME TO TOWN, AS PART OF OUR LARGER GROUP OF MEETING WITH ALL OF CONTRACTING STAFF, THAT A VISIT WITH THEM BECAUSE IT'S ALWAYS NOT ONLY A LEARNING EXPERIENCE BUT A PLEASANT EXPERIENCE. SO, WE TOGETHER WITH THEM -- ALL OF US HERE ON THE STAGE PLANNED THIS EVENT SO THAT WE COULD REACH OUT AND HEAR FROM PEOPLE WHO MAY NOT HAVE THE OPPORTUNITY TO COME TO WASHINGTON, OR WEREN'T SURE HOW TO CONTACT US, OR WHOM TO CONTACT. SO, IN GENERAL, WE CAN BE CONTACTED THROUGH A MAIL BOX THAT IS CALLED "CONTACT NCS NCS@NIH.GOV. WE WANTED TO HAVE A MORE INTERACTIVE TYPE OF DISCUSSION, SO WE DID RECEIVE ONE QUESTION, AND THAT QUESTION WAS: HOW DO WE DEVELOP QUESTIONNAIRES SO THAT THEY INCORPORATE ELEMENTS THAT ARE SENSITIVE TO THE CULTURE AND THE CONTEXT OF DIFFERENT COMMUNITIES? I THINK THAT'S AN EXCELLENT QUESTION. AND IT'S A CHALLENGING ONE. SO, I'LL DESCRIBE OUR PROCESS, BUT WE'RE OPEN TO CHANGE, AND IN FACT WE CONTINUE TO CHANGE AND AMEND OUR PROCESS. SO OUR PROCESS IS WE FIRST THING OF WHAT TYPE OF DATA WE NEED TO COLLECT, AND THEN WE CIRCULATE TO ALL OUR CONTRACTORS -- IN THIS CASE WHEN I USE THE WORD "CONTRACTOR" IT INCLUDES ALL OF THE LOCAL STUDY CENTERS. WE CIRCULATE TO THEM A CONCEPT SHEET. WE SAY, THESE ARE AREAS WHERE WE WOULD LIKE TO COLLECT INFORMATION. AREAS OF SCIENTIFIC INTEREST. DO YOU HAVE ANY COMMENTS? AND THEY, IN TURN, HAVE THE OPPORTUNITY TO CONSULT WITH ANYONE THEY WOULD LIKE TO, AND BRING IN ANY VOICES AND ANY PERSPECTIVES THEY FEEL THEY OUGHT TO BRING IN, AND WE THEN TAKE BACK THE INFORMATION WE GET FROM THEM, AND WE THEN TRY TO GENERATE SPECIFIC QUESTIONS IN THOSE AREAS OF SCIENTIFIC INTEREST. THE QUESTIONS WE USE FOR THE MOMENT ARE GENERALLY QUESTIONS THAT HAVE BEEN IDEA IN OTHER TYPES OF SURVEY RESEARCH. ALTHOUGH WE'RE LOOKING AT MECHANISMS WHERE WE CAN CUSTOMIZE AND DEVELOP OUR OWN QUESTIONS. THEN WE SEND THOSE CANDIDATE QUESTIONS OUT TO THE FIELD AGAIN, AND ASK FOR SPECIFIC INPUT ON THAT LIST OF QUESTIONS. AND THEN IT COMES BACK, AND THEN WE LOOK AT IT, AND THEN WE TURN IT OVER TO OTHER CONTRACTORS WHO DO SOME TECHNICAL ADJUSTMENTS, SUCH AS ASSIGNING DATA ELEMENTS TO THE RESPONSES SO THE QUESTIONS, AND ORDER THE QUESTIONS IN SUCH A WAY THAT THEY LINK TOGETHER IN WHAT WE HOPE IS A LOGICAL FLOW, AND THEN WE GIVE IT TO A TEAM CALLED THE COROGRAPHY -- CHOREOGRAPHY TEAM, AND THAT MEANS, HOW DO WE SET UP A VISIT IN TERMS OF ALL THE ELEMENTS WITHIN THE VISIT, FROM SAYING HELLO, THEIR ON THE TELEPHONE OR IN PERSON TO GETTING TO THE VARIOUS QUESTIONS AND MAKING SURE THAT THERE ARE WAYS THAT PEOPLE CAN HAVE AN OPPORTUNITY TO RESPOND. THEN WHEN ALL THAT IS FINISHED, WE SEND IT TO TWO MORE PLACES. WE SEND IT TO INSTITUTIONAL REVIEW BOARDS AND INSTITUTIONAL REVIEW BOARDS ARE LOCAL OR NATIONAL, AND THEY REVIEW THE MATERIAL, AND THEN WE SEND IT DOWNTOWN, WASHINGTON, DC, TO THE OFFICE OF MANAGEMENT AND BUDGET, AND WITHIN THE OFFICE OF MANAGEMENT AND BUDGET, IS THE OFFICE OF INFORMATION AND REGULATORY AFFAIRS, AND THEIR JOB IS TO BE SURE THAT WE DO NOT BURDEN THE AMERICAN PEOPLE WITH REQUESTS FOR FACT OR OPINION THAT ARE NOT SCIENTIFICALLY JUSTIFIED. SO THEY LOOK AT IT, AND THEY'RE THE FINAL CLEARANCE MECHANISM. THEN WE FIELD-TEST IT, AND IN OUR FIELD-TESTING, WE TRY TO CAPTURE WHAT TYPES OF QUESTIONS PEOPLE RESPOND TO, WHAT TYPES OF RESPONSES THEY PROVIDE, WHETHER IT SEEMS THEY UNDERSTAND THE QUESTIONS OR THEY HAVE SOME POINTS OF POTENTIAL CONFUSION, OR WHETHER THE QUESTIONS ARE JUST DECLINED, WHICH PEOPLE ARE ALLOWED TO DO, AND WE MAKE THEM AWARE THAT IF YOU DON'T WANT TO ANSWER A QUESTION OR DON'T WANT TO DO SOMETHING, YOU DON'T HAVE TO DO IT. AND WE MAKE NOTE OF THAT. AND THEN WE CIRCLE BACK AGAIN, AND ASK, WELL, WHICH OF THESE QUESTIONS IN SOME WAY OR ANOTHER WERE TROUBLESOME OR CONFUSING OR IN SOME WAY OR ANOTHER DIFFICULT FOR PEOPLE TO RESPOND TO. WE ALSO TAKE SOME OF OUR MATERIALS AND WE HAVE THEM TRANSLATED AND THEN BLACK-TRANSLATED INTO DIFFERENT LANGUAGES, PRIMARILY SPANNIC, -- SPANISH, BUT WE HAVE OTHER MATERIALS TRANSLATED INTO SOMEWHAT OF 60 LANGUAGES, AND WE DON'T HAVE EVERY QUESTIONNAIRE TRANSLATE INTO EVERY LANGUAGE BUT WE WANT TO BE SURE THAT THE INSTRUCTIONS AND THE APPROACH TO DATA COLLECTION IN THE STUDY, AND GIVING PERMISSION TO PARTICIPATE, ARE COMMUNICATED IN SUCH A WAY THAT THE PEOPLE UNDERSTAND THEM NOT ONLY LINGUISTICALLY BUT CULTURALLY, AND SO THAT'S OUR APPROACH AND BECAUSE IT TOOK SEVERAL MINUTES TO DESCRIBE IT, YOU MIGHT REALIZE IT'S A COMPLICATED APPROACH. IT'S A COMPLEX FLOW DIAGRAM BUT WE DO IT THIS WAY BECAUSE WE WANT PEOPLE TO FEEL COMFORTABLE AND WE WANT THEM TO PROVIDE US WITH THE INFORMATION THAT WILL HELP IMPROVE THE HEALTH OF CHILDREN. SO, I'M SURE THAT THERE ARE ADDITIONAL QUESTIONS AND GAPS, AND I'M GOING TO TURN TO OUR PANEL HERE AND SEE IF THERE ARE ANY COMMENTS OR QUESTIONS ON THAT PARTICULAR TOPIC, AND THEN MOVE ON TO ANY OTHER TOPICS YOU'D LIKE TO. >> FORGIVE ME IF I MISSED IT IN YOUR ANSWER. THERE'S A LOT OF STEPS INVOLVED IN THE PROCESS. AND ONE OF THE PIECES I TOOK OUT OF THIS QUESTION WAS KIND OF THE QUESTION OF HOW WE, AS STUDY CENTERS OR IN THE PROGRAM OFFICE, CAN INCORPORATE MORE ELEMENTS OF COMMUNITY ENGAGEMENT IN THE DEVELOPMENT OF THOSE QUESTIONNAIRES, SO WE KNOW THAT THOSE -- THAT THEY ARE REFLECTIVE OF THE KIND OF THINGS THAT COMMUNITY MEMBERS ARE GOING TO BE COMFORTABLE ANSWERING AND ARE GOING TO BE ABLE TO BE INVOLVED IN THAT AS OPPOSED TO -- WELL ISSUE GUESS THAT'S THE END OF THE QUESTION. >> SURE. SO, IN THIS CASE, OUR MAJOR RELIANCE IS ON THE CIRCULATION OF THE QUESTIONS -- FIRST THE DRAFT TOPICS AND THEN THE ACTUAL DRAFT QUESTIONS, OUT TO THE FIELD, AND THAT IS WHERE WE FEEL WE WOULD GET BOTH A TECHNICAL EXPERTISE AND ALSO THE LOCAL INPUT, AND THROUGH THAT TWO-STEP PROCESS, BY SENDING IT OUT TO THE FIELD TWICE, WE ARE UNAWARE THAT ANY OTHER STUDY DEVELOPED ON THIS CAMPUS FOLLOWS THAT PROCESS. WE ASKED AROUND, AND THAT IS OUR CURRENT MECHANISM TO OFFER THE OPPORTUNITY, BUT I THINK YOU'RE CORRECT TO SAY THERE'S ASSUMPTION AND THERE'S POTENTIAL GAPS BECAUSE WHAT HAPPENS IF WE GIVE IT TO SOMEBODY OUT IN THE FIELD AND THEY LOOK AT IT AND SAY, LOOKS FINE, AND DON'T CIRCULATE IT FURTHER? SO WE DON'T HAVE THAT ASSURANCE, BUT MAYBE WE SHOULD IN THE FUTURE ASK FOR A CHECKLIST? WHOM DID YOU CONSULT AND WHAT CHANGES ARE MADE? WE DO GET THE CHANGES BACK AND KNOW WHAT ARE MADE, BUT WE HAVEN'T OURSELVES FELT IT WAS IMPORTANT TO KNOW WHO SUGGESTED THE CHANGE. WE JUST WANTED TO SEE IF THERE WERE CHANGES. CARL HILL. >> IN ADDITION TO THOSE STEPS, I'VE HAD SOME INVOLVEMENT WITH THE QUESTIONNAIRE DEVELOPMENT TEAM, AND THERE'S ALWAYS THE CONSIDERATION OF WHETHER THE MEASURE OR THE PARTICULAR SET OF QUESTIONS HAS BEEN VALIDATED ON A DIVERSE SET OF POPULATION. SO, THAT'S ALWAYS A QUESTION THAT WE POSE IN THE PROGRAM OFFICE, AND AT ONB. DR. HIRSCHFELD MENTIONED THE NEXT STEP, THAT ONB REQUESTS THAT KIND OF INFORMATION BEFORE, PROVIDING ANY TYPE OF CLEARANCE. >> I'LL JUST NOTE THAT IT'S IMPORTANT FOR SCIENTIFIC INTEGRITY TO ASK THE SAME QUESTION EVERYWHERE. WE CAN'T HAVE INSTRUMENTS DEVELOPED JUST FOR A CERTAIN LOCATION BECAUSE THEN IT'S NO LONGER A NATIONAL STUDY. MR. JONES, I THINK YOU HAD A QUESTION OR COMMENT? NO? OKAY. >> WE CERTAINLY INTENDED THIS TO BE A VERY INTERACTIVE EXPERIENCE, AND SO ALTHOUGH WE HAVE A SMALL GROUP OF QUESTIONS THAT WE'RE PREPARED TO OPEN UP FOR DISCUSSION, WE WANTED TO MAKE SURE WE OFFERED THE AUDIENCE AN OPPORTUNITY TO COME FORWARD WITH ANY QUESTIONS. SO IF THERE ARE ANY IN THE AUDIENCE, WE'LL CERTAINLY TAKE THEM. >> I HAVE TWO I'VE RECEIVED THROUGH THE E-MAIL ALREADY. >> WHY DON'T WE GO WITH THOSE FIRST. >> LET ME SEE IF I CAN BE FAIR AND DO THEM BY THE TIME THEY WERE COMING IN. YES. SO THE FIRST ONE IS, QUOTE: CAN YOU PLEASE ADDRESS THE ANTICIPATED ROLE OF COMMUNITY ADVISORY BOARDS IF THE NUMBER OF CONTRACTORS ARE BEING CONSOLIDATED? WE HAVE SPENT A LOT OF ENERGY MAKING THIS A LOCAL STUDY, BUT THIS SEEMS TO TAKE US DOWN A MUCH DIFFERENT PATH. >> SO I'M ALWAYS A LITTLE CHALLENGED BY IMPERSON PRONOUNS SO I HAVE TO INTERPRET AND SAY THAT THE "THIS" MIGHT BE THE CONSOLIDATION PROCESS. BUT WE HAVE PUT INTO OUR PROCUREMENT ANNOUNCEMENT, WHICH IS TECHNICALLY THE DOCUMENT THAT CALLS FOR NEW CONTRACTS -- THAT WE SPECIFICALLY WOULD LIKE TO ESTABLISH REGIONAL ADVISORY BOARDS AND THE REGIONAL ADVISORY BOARDS THAT WOULD THEN WORK WITH THE LOCAL COMMUNITY ADVISORY BOARDS, AND WE WOULD LIKE TO SEE HOW THEY INTERACT, AND WE FELT WE COULDN'T PROSCRIBE A PROCESS BECAUSE THIS IS RELATIVELY NEW. SO, WE LEFT IT QUITE OPEN AND WE JUST SAID -- AND WE DEVOTED SEVERAL PARAGRAPHS IN OUR DOCUMENT TO THIS THEME -- THAT THE CONTRACTORS, WHOEVER IS WAIVEDDED THE NEW CONTRACT, MUST ESTABLISH A REGIONAL ADVISORY BOARD, AND THAT REGIONAL ADVISORY BOARD MUST REACH OUT TO THE LOCAL ADVISORY BOARDS AND THEY WILL COME UP WITH A PLAN TO SEE WHO IS GOING TO DO WHAT AND SO FORTH, SO THAT WE HAVE A CONTINUITY OF INPUT ON MULTIPLE LEVELS FOR THE STUDY. AND WE'LL STAY TUNED AND SEE HOW THAT WORKS OUT, BUT THIS, I THINK, WAS AN IMPORTANT TOPIC FOR US AND ONE WHERE WE HAVE SPECIFIC REQUESTS ON THE PART OF WHOEVER IS GOING TO BE IN THE FIELD IN THE STUDY, TO FOLLOW THROUGH WITH. THE SECOND QUESTION IS, WE ARE PART OF THE COMMUNITY ADVISORY BOARD THAT IS UP AND RUNNING. WHAT FACTORS WILL DECIDE HOW RECRUITMENT WILL TAKE PLACE AND WHICH LOCATIONS WILL BE USED FOR THE MAIN STUDY. SO, THE FACT IS THAT WE'LL DECIDE HOW RECRUITMENT WILL TAKE PLACE HAVE BEEN THE TOPIC OF DISCUSSION -- PUBLIC DISCUSSION SINCE APRIL 2011, AND THAT WAS BASED ON BOTH PUBLISHED LITERATURE BUT, FAR MORE IMPORTANT, OUR OPEN FIELD EXPERIENCE, WHICH INDICATED THAT WE WOULD BE LOOKING AT ALTERNATIVE APPROACHES TO GOING OUT IN NEIGHBORHOODS AND KNOCKING ON DOORS. THAT CAN BE DONE, BUT IT'S NOT COST EFFECTIVE OR, IN OUR CASE, TIME EFFECTIVE. WE ESTIMATED THAT IF WE HAD THE RATE OF ENROLLMENT THAT THE FIRST YEAR AND A HALF OR SO OF THE STUDY -- BECAUSE THE FIELD WORK BEGAN IN JANUARY 2009. AND BY JANUARY 2011, WE HAD ENOUGH EVENTS AND ENOUGH RECRUITMENT, WE THOUGHT, TO BEGIN TO UNDERSTAND THE STRENGTHS AND ALSO THE LIMITATIONS OF THAT APPROACH. SO, WE BEGAN A SERIES OF DISCUSSIONS IN APRIL 2011 ON USING HEALTHCARE PROVIDERS AS THE PRIMARY MEANS OF RECRUITMENT. NOT THE ONLY ONE. WE LEARNED YOU HAVE TO USE A BLEND OF APPROACHES, BUT IT'S THE PRIMARY ONE WE WOULD USE. SO, BETWEEN APRIL 2009 UNTIL NOW, -- I'M SORRY, APRIL 2011 UNTIL NOW, WE HAVE HAD MULTIPLE PUBLIC MEETINGS AND THEN WE HAVE HAD DISCUSSIONS WITH ACADEMIC SOCIETIES, PROFESSIONAL SOCIETIES, WITH VARIOUS GROUPS, AND WE HAVE RECEIVED MUCH INPUT AND BASED ON THE INPUT AND BASED ON THE DATA, WE FEEL THAT WE WOULD USE HEALTHCARE PROVIDERS AS A RECRUITMENT MECHANISM NOW, DECIDING HOW YOU'RE GOING TO RECRUIT, DOESN'T TELL YOU WHERE YOU'RE GOING TO RECRUIT, AND THAT IS SOMETHING WE NEED TO SEPARATE OUT BECAUSE SOMETIMES PEOPLE LINK THE HOW YOU ROW CRUDE WITH THE WHERE YOU'RE GOING RECRUIT, AND THE WHERE YOU'RE GOING RECRUIT IS AN ENTIRELY DIFFERENT QUESTION. SO ONE WAY TO LOOK AT RECRUITMENT IS, YOU WOULD SAY, WELL, WHY DON'T WE JUST ASK A GROUP OF HEALTHCARE PROVIDERS TO VOLUNTEER AND MOVE PEOPLE INTO THE STUDY. BUT WE WOULD INTRODUCE A LOT OF BIASS INTO THE STUDY, AND WE'RE TRYING TO MAKE IS A STUDY THAT WOULD TRULY BE NATIONAL AND NOT ONLY THE AREAS WHERE THE STUDY OCCURS, BUT IN THE DATA THAT WOULD BE PRODUCED BY THE STUDY. SO, WE, AGAIN, WENT THROUGH A SERIES OF DISCUSSIONS, STARTING IN THE FALL OF 2011, AND CONTINUING UNTIL THE LAST ONE SCHEDULED IS AT THE END OF THIS MONTH, JULY 2012, WHERE WE'RE TAKING INPUT INTO THE AREAS, AND ONE WAY THAT WE COULD APPROACH THIS IS TO SAY, WHY DON'T WE USE THE SAME AREAS WE ALREADY HAVE BUT WE WANT TO BE SURE THAT WE HAVE RECEIVED ALL THE INPUT WE CAN, AND SEE IF WE SHOULD STAY WITH WHAT WE HAVE OR COME UP WITH SOME PROCESS AND JUSTIFICATION FOR COMING UP WITH ANOTHER PROCESS WOULD BE THAT IT WOULD HAVE TO BE A CLEAR IMPROVEMENT. SO, THAT'S A TOPIC THAT WE CONTINUE TO TAKE INPUT ON, AND WE DON'T KNOW WHERE THE AREAS MAY BE. SO, IN ONE SCENARIO, WE'RE WHERE WE ARE OR PLANNING TO BE, AND ANOTHER SEE SEE ANYWHERE -- SCENARIO WE WOULD HAVE SOME RANDOM SELECTION OF AREAS ACROSS THE COUNTRY, AND THEN EVERYPLACE HAS AN EQUAL CHANCE SO WE MIGHT END UP IN SOME OF THE SAME PLACES, DIFFERENT PLACES. WE JUST DON'T KNOW. SO THOSE ARE THE TWO SEPARATE QUESTIONS. THEY, HOW WE DO RECRUITMENT WE DECIDED AND WENT THROUGH AN EXTENSIVE CONSULTATION PROCESS TO DO SO, AND THE WHERE IS YET TO BE DECIDED BET BUTT WE KNOW GENERALLY HOW AND THAT IS WE WANT TO SELECT SAMPLE THAT WILL BE BROADLY DISTRIBUTED, HAVE DIVERSE POPULATIONS, AND ADDRESS HEALTH -- DISPARATESIES BECAUSE THAT'S WHAT THE LAW TELLS US TO DO. ANYONE WANT TO COMMENT ON THOSE TWO POINTS BEFORE I GO ON TO ANOTHER QUESTION SNEER. >> THE FIRST QUESTION, THE RELATIONSHIP OF THE LOCAL CABS AND THE NEW REGIONAL ADVISORY OR THE REGIONAL CABS, I'M RECOLLECTING THAT IF DON'T MEASURE IT, IT DOESN'T COUNT, AND I WONDER HOW WE CAN BUILD IN ACCOUNTABILITIES FOR COMMUNITY ENGAGEMENT TO BE SURE IT'S NOT JUST WORDS IN A DOCUMENT OR CONTRACT BUT THAT COMMUNITY ENGAGEMENT IS REALLY IMPORTANT AND DOES HELP TO INFORM THE STUDY? >> GREAT QUESTION. SO WE HAVE DEVELOPED FOR THE STUDY OVERALL A DATA COLLECTION APPROACH -- WHICH HAS NOT BEEN SYSTEMATICALLY APPLIED AND WE ACTUALLY WANT TO MEASURE HOW THE OPERATIONS FUNCTION, AND WE INVESTED INTO BUILDING A CATALOGUE OF OPERATIONAL DATA ELEMENTS BECAUSE WE FEEL WE NEED TO HAVE OBJECTIVE DATA IN ORDER FOR US TO UNDERSTAND ALL THE DIMENSIONS OF ALL THE OPERATIONS. COMPLEX STUDY, COMPLEX OPERATIONS, MANY MOVING PARTS. SO, OUR TASK IS IN ONE WAY STRAIGHTFORWARD, AND THAT IS WE ALREADY HAVE A MECHANISM IN PLACE TO COLLECT AND MEASURE INTERACTIONS, AND OUR CHALLENGE AND RESPONSIBILITY IS TO IMPLEMENT IT. SO, THE WAY WE DO THAT IS WE PUT OUT INSTRUCTIONS TO OUR CONTRACTORS, AND SAY, SEND US THE OPERATIONAL DATA ELEMENTS, AND WE HAVE FOUND INITIALLY THERE WAS A CULTURAL EDUCATION THAT WE HAD TO ENGAGE IN, BECAUSE PEOPLE WANT TO FOCUS ON THE EXPOSURE RESPONSE, BUT FOR THE VANGUARD STUDY, IT'S KEY FOR US TO UNDERSTAND THE OPERATIONS. SO, WHILE WE MAY ASK QUESTIONS ABOUT, DID YOU EAT OATMEAL OR RICE KRISPYS FOR BREAKFAST, THE 'REASON OF THE STUDY IS HOW TO DO WE GET INTO A HOUSE AND ASK QUESTIONS ABOUT DIET AND BE SURE THAT THOSE RESPONSES ARE ACCURATE AND INTERPRETABLE. SO, WE'RE AT THIS POINT -- WE WANT TO GET AN ANSWER, BUT THE SCIENTIFIC QUESTION AND THE HIGH MOTH THIS OF THE STUDIS, CAN 2010 AN ANSWER? AND WE DO THAT WITH OTHER OPERATIONS. DO WE GET IMPLEMENTED IN THE FIELD THE TYPES OF ACTIVITIES THAT WE BELIEVE AND WE EXPECT WOULD GIVE US THE STUDY WE WANT. SO, THAT'S THE TECHNICAL MECHANISM, AND THAT IS PART OF THE LARGER FRAMEWORK OF TRYING TO BE EVIDENCE-BASED, DATA-DRIVEN, AND PARTICIPANT AND COMMUNITY-INFORMED, BECAUSE WE ARE ASKING THE COMMUNITY AND THE PARTICIPANTS TO INFORM US. DOES THAT ADDRESS YOUR QUESTION QUESTION. >> CAN I HAVE ANOTHER FOLLOWUP THE FIRST QUESTION? WE'VE FOR THE LAST FIVE MONTHS OR SO OUR GROUP HAS BEEN REACHING OUT TO LOCAL CABS DIRECTLY AND THROUGH THEIR COMMUNITY ENGAGEMENT STAFF, AND HAVE ENCOUNTER -- THERE'S BEEN QUITE A BIT OF A FEELING OF UNCERTAIN AND CONFUSION DURING THIS TRANSITION PHASE AND MANY LOCAL CABS ARE CONCERN ABOUT HOW THEY'RE BEING ENGAGED. AND I WONDER IF YOU COULD SPEAK TO THEM ABOUT HOW THE CURRENT ENGAGEMENT WOULD WORK. >> THE CURRENT ENGAGEMENT, WE ARE DELEGATING IN GENERAL THE SPECIFIC INTERACTIONS TO THE FIELD CONTRACTORS BECAUSE WE DID NOT CENTRALLY SELECT OR INTERACT OR HAVE RELATIONSHIPS SPECIFICALLY WITH THE LOCAL CABS. WE WANTED THAT MECHANISM IN PLACE, AND WERE INTERESTED IN FOLLOWING IS, BUT WE DON'T HAVE THE KNOWLEDGE OR THE RELATIONSHIPS TO BUILD ON. SO, WHAT WE DID IS WHEN WE SAW THAT IT WAS GOING TO BE COMING TIME FOR EXPIRATION OF CONTRACTS AND THERE WOULD BE A TRANSITION, WE PREPARED NATIONALLY SOME MATERIAL AND SAID, CUSTOMIZE THIS FOR LOCAL USE. BUT WE HAVE NOT, BY DESIGN, TAKEN THE INITIATIVE TO SPECIFICALLY GET INVOLVED IN EVERY COMMUNITY ADVISORY BOARD INTERACTION. NOW, SOME HAVE REACHED OUT TO US NATIONALLY, AND WE'VE WRITTEN TO THEM, AND WHEN TIME AND FINANCES PERMIT, WE EVEN VISIT. I HAD A GREAT VISIT TO WISCONSIN. RIGHT? AND SO WE -- BUT WE DON'T WANT TO BE STEPPING ON EACH OTHER AS WE GO FORWARD. SO WE'VE LEFT IT PRIMARILY BY US PROVIDING AS BEST GUIDANCE AS WE CAN FROM A DISTANCE, AND THEN RELYING ON FEEDBACK AND INTERACTION, AND WE WOULD LIKE THAT FEEDBACK AND INTERACTION TO HELP IMPROVE THE PROCESS. WE DON'T WANT PEOPLE TO FEEL CONFUSED. WANT PEOPLE TO UNDERSTAND THAT EVEN IF THE CONTRACTOR CHANGES -- AND IT MAY OR MAY NOT. OKAY? BUT EVEN IF THE CONTRACTOR CHANGES, THE PARTICIPANT ARE IN THE STUDY FOR THE NEXT 20 YEARS OR SO. THE COMMUNITIES ARE IN THE STUDY FOR THE NEXT 20 YEARS OR SO, AND OUR COMMITMENT IS ON NATIONAL STUDY AND MAINTAINING THAT NETWORK OF LOCATIONS AND PARTICIPANTS. FOR US, THE TOUGHEST PART WOULD BE IF WE HAD PEOPLE LEAVE THE STUDY, BECAUSE EVERY INDIVIDUAL IN THE STUDY REPRESENTS MANY, MANY OTHER PEOPLE. AND IF WE HAVE ONE PERSON LEAVE THE STUDY-IT'S NOT JUST ONE PERSON. IT'S THAT PERSON REPRESENTING MANY OTHER PEOPLE THAT IS IMPORTANT TO US. SO, WE HAVE WORKED WITH THE FIELD CONTRACTORS TO ESTABLISH A COLLABORATIVE IMPROVEMENT NETWORK, TO IDENTIFY THE FACTORS THAT INFLUENCE RETAINING PEOPLE IN THE STUDY. AND FROM MY PERSPECTIVE, THEY'VE DONE A TERRIFIC JOB. THEY'VE IDENTIFIED FACTORS. THEY'VE IDENTIFIED THE INFLUENCES ON THOSE FACTORS, AND THEY HAVE BEGUN FIELD, TESTING OF VARIOUS STRATEGIES, AND I THINK THAT IS THE APPROACH WE HAVE TO USE TO GIVE PEOPLE THE CONFIDENCE AND GIVE THEM THE REASSURANCE THAT CONTRACTORS MAY CHANGE BUT THE COMMITMENT DOESN'T CHANGE. AND -- SURE GO AHEAD. I WAS GOING TO READ ANOTHER QUESTION. GO AHEAD. >> ACTUALLY, THANK YOU. I'M LIKE TIM I WAS RECOMMENDED BY THE UNIVERSITY MINNESOTA THAT I WAS SELECTED TO BE NATIONAL REPRESENTATIVE. DURING THIS TRANSITION, HOW DO YOU DESCRIBE US, THE NATIONAL COMMUNITY REPRESENTATIVES AND OUR ROLES TO OTHERS? >> THE SAME WAY I WOULD DESCRIBE YOU WHEN WE FIRST WANTED YOU COME. THAT IS, DON'T THINK THE TRANSITION OF THE CONTRACTS AND THAT'S NOT A ONE-DAY EVENT. THIS IS A PROCESS THAT'S GOING TO TAKE A YEAR AND A HALF. BUT I DESCRIBE TO ME -- THIS IS JUST MY PERSONAL IDEA -- AS VOICES THAT WE NEED TO HEAR. AND WE DIDN'T HAVE A MECHANISM TO HEAR THOSE VOICE, AND PERSPECTIVES THAT COME TO US. WE WANT TO MAKE SURE, IF WE'RE MAKING REQUESTS OF PEOPLE, IF WE'RE THINKING ABOUT HOW WE COLLECT DATA, HOW WE COMMUNICATE WITH PEOPLE, THAT WE HAVE PEOPLE THAT CAN DIRECTLY INFORM US, IN ADDITION TO THE INDIRECT INFORMATION WE GET FROM THE OTHER COMMUNITY ADVISORY BOARD. SO, IN MY MIND, YOU'RE NOT A REPLACEMENT OR SUBSTITUTE. YOU'RE A COMPLIMENT AUGMENTATION, AND YOU PROVIDE US A DIRECT LINK WHICH WE DIDN'T HAVE UNTIL YOU VOLUNTEERED TO PARTICIPATE WITH US. NO MATTER WHAT, TRANSITION, NO TRANSITION, NEW PROTOCOL, DIFFERENT QUESTIONS, WHATEVER IT IS, THERE ARE NO BOUNDS TO THE ACTIVITIES, AND THE ENTIRE STUDY IS ABOUT INTANGIBLES. THE ENTIRE STUDY IS ABOUT RELATIONSHIPS THAT WE BUILD WITH PARTNERS. THE ENTIRE STUDY IS ABOUT RELATIONSHIPS THAT PEOPLE BUILD WITH FAMILIES, AND THE TRUST THAT THE FAMILIES PLACE IN THE ENTERPRISE OF THE STUDY, TO SHARE THEIR LIVES, SO THAT THEIR LIVES WILL INFORM NOT ONLY OTHER FAMILIES BUT FAMILIES THAT HAVEN'T EVEN BEEN FORMED YET. CHILDREN THAT HAVEN'T BEEN BORN YET. THAT'S THE LEVEL OF INFLUENCE THAT OCCURS. SO, WE HAVE TO START WITH THOSE PRINCIPLES, AND FOR US, YOU'RE AN IMPORTANT PART OF THAT PICTURE. >> SO, THE QUESTION HERE THAT READS: IF OUR COUNTY REMAINS IN THE STUDY AND THE COUNTY SITE IS NOT CHOSEN TO CONTINUE, HOW IS IT COST EFFECTIVE TO SEND INDIVIDUALS FROM ANOTHER AREA TO VISIT THE PARTICIPANTS IN THEIR HOMES AND TRAVEL TO THE HOSPITALS WHEN THE PARTICIPANTS GIVE BIRTH? ASIDE FROM THAT, WHAT TYPE OF BOND WILL BE ESTABLISHED BETWEEN THE NEW CONTRACTOR AND THE PARTICIPANT WHEN THEIR RELATIONSHIP HAS ALREADY BEEN ESTABLISHED WITH ANOTHER TEAM? I WORRY ABOUT THE WASTE OF VALUABLE RESOURCES, MONEY, TIME, AND ENERGY, OF COMMITTED INDIVIDUALS TO THE NATIONAL CHILDREN'S STUDY. >> SO I'LL BEGIN, ALTHOUGH LOCATIONS CURRENTLY IN THE STUDY WILL REMAIN IN THE STUDY. WE'RE NOT GOING TO CHOOSE OTHER LOCATIONS. SO THIS COUNTY WILL BE IN THE STUDY FOR THE NEXT COUPLE OF DECADES. SO, WE DID WRITE A LETTER TO THIS COUNTY BOARD, BUT MAYBE WE HAVE TO REENFORCE THE MESSAGE THAT WE ARE NOT GOING TO BE CHANGING LOCATIONS ONCE A LOCATION IS ACCEPTED. >>> IN TERMS OF THE TEAM AND INVESTMENTS, I LIKE TO VIEW US GOING FORWARD THE SAME AS PEOPLE AND THOSE OF WHITE HOUSE ARE PARENTS AND HAVE KIDS IN SCHOOL. YOU SPEND A PERIOD OF TIME IN A CERTAIN GRADE AND YOU GET INVOLVED IN ALL THEIR ACTIVITIES AND YOU FORM BONDS WITH THE TEACHER AND BONDS WITH THE PARENTS AND SO FORTH, AND YOU GO THROUGH THAT PHASE, BUT THEN COMES A NEW SCHOOL YEAR, AND YOU HAVE A CHANCE TO REWORK IT, AND IF YOU HAVE SOME CONTINUITY, WELL, THE PEOPLE THAT YOU WERE WITH, INTRODUCE YOU TO THE NEW PEOPLE, AND YOU BUILD ON WHAT YOU HAVE. SO WE LIKE TO TAKE THAT MODEL -- AND THOSE ARE SPECIFIC INSTRUCTIONS TO OUR CURRENT CONTRACTORS, TO WORK WITH THE PARTICIPANTS AND WORK WITH THE COMMUNITIES TO INFORM THEM THAT CHANGES CAN OCCUR, AND, FURTHERMORE, ONCE WHOEVER THE NEW CONTRACTOR MAY BE -- AGAIN, IT COULD BE THE SAME TEAM AS BEFORE, JUST DEPENDS ON HOW THE PROPOSALS ARE EVALUATED -- BUT IF IT'S A NEW TEAM, THAT THE CURRENT TEAM WOULD WORK WITH THE NEW TEAM TO INTRODUCE THE PEOPLE AND TO GIVE THE NEW TEAM A CHANCE, BECAUSE THEY WILL BE WITH THE COMMUNITY FOR FIVE YEARS, AND THERE WILL BE ANOTHER CHANCE TO LEARN NEW THINGS BECAUSE THE CHILDREN GROW, THE STUDY CHANGES, THE TYPES OF QUESTIONS WE WILL BE ASKING ARE CHANGED. WE'LL BE INTRODUCING NEW TECHNOLOGIES. SO, CHANGE IS GOING TO BE PART OF THE STUDY, AS WE GO FORWARD. AND ON A PERSONAL LEVEL, I SEE NO BARRIER TO MAINTAINING RELATIONSHIPS WITH PEOPLE THAT YOU HAVE RELATIONSHIPS WITH. BUT ON THE PROFESSIONAL LEVEL, ONCE PEOPLE ARE IN THE STUDY, OUR INTENT IS THAT WE TREAT THEM WITH RESPECT AND CONVEY TO THEM HOW VALUABLE THEY ARE, AND THAT THEY UNDERSTAND THAT THEY ARE PART OF A NATIONAL STUDY, AND THAT THEY WILL WORK WITH THE TEAM THAT REPRESENTS THAT NATIONAL STUDY, WHETHER IT'S THE TEAM THEY'VE WORKED WITH BEFORE OR A NEW TEAM, AND THAT THE NEW TEAM WOULD BE SELECTED BECAUSE THEY HAVE THE PERSONNEL AND THE QUALIFICATIONS AND ALL OF THE OTHER ASSETS THAT WOULD GIVE THEM THE OPPORTUNITY TO LEARN THE FAMILIES AND TO PROVIDE THE DATA. WE FOUND ONE OTHER AREA OF POTENTIAL MISMATCH IN EXPECTATIONS IN THAT SOME PEOPLE HAVE AN IMPRESSION THAT THE NATIONAL CHILDREN'S STUDY PROVIDES HEALTH CARE, AND IT DOES NOT. WE ARE NOT AUTHORIZED TO PROVIDE HEALTH CARE. WE'RE NOT LICENSED TO PROVIDE HEALTH CARE. WE ARE A RESEARCH STUDY, AND SO WE WILL WORK AND WANT TO WORK IN A COORDINATED AND COMPLIMENTARY FASHION WITH WHATEVER HEALTH CARE RESOURCES ARE LOCAL, AND WE DO REACH OUT AND WISH TO ENGAGE THE LOCAL HEALTHCARE COMMUNITY, BUT WE COULD NOT PROVIDE HEALTH CARE, AND I DON'T WANT SOMEONE TO FEEL THAT THEIR HEALTH CARE IS COMPROMISED BECAUSE THE RESEARCH TEAM MAY TRANSITION WITH TIME. I'M CONCERNED ABOUT THE RELATIONSHIP THAT HAS GROPE BETWEEN OUR PARTICIPANTS AND OUR LOCAL STAFF. NOW WHAT? HELP ME UNDERSTAND. SO, THIS I BELIEVE IS SOMEWHAT SIMILAR TO THE PRIOR QUESTION, AND THERE ARE MANY OPTIONS. TO BEGIN WITH, WE BELIEVE AND WE HAVE TRIED TO POSITION THE NATIONAL CHILDREN'S STUDY SUCH THAT ANYONE THAT HAS WORKED FOR OR WITH THE NATIONAL CHILDREN'S STUDY, WOULD BE TRAINED IN THE MOST MODERN STATE-OF-THE-ART RESEARCH METHODS, AND WE ANTICIPATE THAT PEOPLE WHO HAVE WORKED WITH THE NATIONAL CHILDREN'S STUDY SHOULD HAVE THE SKILL SET THAT WOULD ALLOW THEM TO WORK FOR MANY KINDS OF EMPLOYERS AND MANY CONTEXTS AS WELL AS JUST THE NATIONAL CHILDREN'S STUDY. SO, THE RELATIONSHIPS COULD CONTINUE IF, FOR INSTANCE, A NEW CONTRACTOR CAME AND WISHED TO ENGAGE SOME OF THE TEAM OR INDIVIDUALS FROM THE PRIOR CONTRACTOR. THIS IS PRACTICE THAT OCCURS FAIRLY ROUTINELY IN MANY SPHERES OF RESEARCH. ANOTHER OPTION IS THAT THE PEOPLE WHO PARTICIPATE IN THE STUDY WOULD REMAIN OPEN AND WOULD BE WILLING TO BE INTRODUCED BY THE CURRENT TEAM THAT THEY HAVE RELATIONSHIPS WITH TO NEW MEMBERS, AND JUST LOOK AT THE TEAM AS EXPANDING. AND THE THIRD IS THAT, AS INDIVIDUALS, WE ARE QUITE OPEN TO MAINTAINING RELATIONSHIPS OUTSIDE THE STUDY. THERE'S PARTICULAR PEOPLE FEEL THEY HAVE BONDS AND INTEREST IN THEIR FAMILY, THAT'S VALUABLE. THAT SPECIAL. SO WE ENCOURAGE PEOPLE THAT WISH TO REMAIN IN TOUCH TO REMAIN IN TOUCH. BUT I'LL GO BACK TO THE ANALOGY OF GOING THROUGH THE SCHOOL OR GOING THROUGH SOME OTHER TIME LIMITED ACTIVITY. BECAUSE THE SCHOOL YEAR ENDS DONE MEAN YOU CAN'T BE IN TOUCH WITH THE PEOPLE ANYMORE. AND IN TERMS OF ALLOWING A NEW TEAM IN, I THINK WE HAVE TO FRAME THE STUDY SUCH THAT EVERY FIVE YEARS, APPROXIMATELY, WE WILL HAVE AN OPPORTUNITY FOR TRANSITION, AND IN SOME CASES THAT TRANSITION WILL BE TO A NEW TEAM AND SOME CASES NOT, BUT THAT'S SOMETHING WHICH WE CANNOT CONTROL AND SHOULD NOT CONTROL, BECAUSE THAT WOULD VIOLATE THE SPIRIT OF FREE COMPETITION FOR CONTRACTING FUNDS. >> IF ANOTHER QUESTION. WHEN THE VANGUARD PROTOCOL WAS DESIGNED WAIT THE INTENTION OF THE PROGRAM OFFICE TO TRANSITION CENTERS FROM ACADEMIC INSTITUTIONS TO ALTERNATE CONTRACTORS? IF SO, WHAT WAS THE REASON FOR NOT BEING TRANSPARENT AT THAT TIME WITH THE CENTER'S CONTRACTORS? >> THE VANGUARD PROTOCOL WHEN IT WAS INITIALLY DESIGNED -- IT'S A LITTLE HARD TO PIN POINT THAT DATE BUT I PUT IT AROUND 2007. AND THERE WAS A REVIEW OF THAT PLAN BY THE INSTITUTE OF MEDICINE, WHICH IS PART OF THE NATIONAL ACADEMY OF SCIENCES, AND THE REVIEW OCCURRED AFTER THE CONTRACTS WERE AWARDED, AND THE REVIEWS MENTION SEVERAL STRENGTHS -- THERE WERE FIVE STRENGTHS ABOUT THE PLAN, AND EIGHT MAJOR WEAKNESSES, AND ONE OF THE WEAKNESSES NOTED IN THE REVIEW WAS THAT THERE WERE TOO MANY CONTRACTORS RELATIVE TO THE OPERATIONS. AND I'M PARAPHRASING IT, BUT ESSENTIALLY IT RAISED QUESTIONS ABOUT THE NUMBER OF CONTRACTS AND THE CONSISTENCY OF DATA COLLECTION. SO, WE -- WHEN OUR TEAM CAME INTO THE STUDY, THE CONTRACTS WERE ALREADY AWARDED. SO WE FELT WE WOULD GO WITH THE SYSTEM THAT WAS IN PLACE AND SEE WHAT WOULD HAPPEN, AND WE WATCHED AND WE OBSERVED AND GAVE TASKS TO ALL THE VARIOUS CONTRACTORS, WHAT WE LEARNED WAS THAT THE NATIONAL ACADEMY OF SCIENCES REVIEW HAD SOME IMPORTANT POINTNESS -- POINTS IN TERMS OF THEIR APPROACH, AND ONE POINT IN WHICH THEY DIDN'T ANTICIPATE BUT WHICH WE FOUND TO BE VERY POINT IN TERM -- VERY IMPORTANT IN TERMS OF THE OVERALL RESEARCH INFRASTRUCTURE AT THE NATIONAL INSTITUTES OF HEALTH, WAS THAT WE CAN IMPROVE QUALITY AND LOWER COSTS BY DOING CONSOLIDATION. SO, THE INSTITUTES OF HEALTH BEGAN DEVELOPING A SYSTEM CALLED THE CLINICAL TRANSLATIONAL SCIENCE AWARDS CONSORTIUM. IN ORDER TO HAVE A NATIONAL INFRASTRUCTURE RATHER THAN HAVING MULTIPLE INDEPENDENT INFRASTRUCTURES WHICH WERE CUSTOM ASSEMBLED FOR SPECIFIC STUDIES AND THEN DISASSEMBLED AGAIN, AND IN THAT PROCESS WE MADE A VERY INTERESTING AND, I THINK, CRITICAL OBSERVATION, AND THAT IS OF THE 36 STUDY CENTERS WE HAD, ABOUT 28 OF THEM WERE IN THE CTSAs, SO WE CULTURALLY WERE MOVING IN THE SAME DIRECTION, AND IT WAS NOT THE INTENT OF THE PROGRAM OFFICE WHEN THESE CONTRACTS WERE FIRST AWARDED TO HAVE CONSOLIDATION PROCESS. BUT OVER THE LAST SEVEN YEARS, THE FIELD OF CLINICAL RESEARCH HAS MOVED TOWARD STANDARDS, MOVED TOWARD CONSOLIDATION, AND MOVED TOWARD COST EFFECTIVE MECHANISMS TO IMPLEMENT THIS STUDY. SO, WE ARE FOLLOWING WHAT WE FEEL ARE -- NOT JUST WHAT WE FEEL -- WHAT WE'RE INFORMED ARE THE PRIORITIES OF THE AGENCY, THE PRIORITIES OF THE FIELD, AND MOVING TO A CONSOLIDATE MODEL. NOW, THAT DOES NOT IN ANY WAY IMPLY NAT THERE'S A DISTINCTION BETWEEN AN ACADEMIC INSTITUTION AND SOME OTHER TYPE OF CONTRACTOR. ON THE CONTRARY. WE'RE TRYING TO MOVE THE ACADEMIC INSTITUTIONS TOWARD THIS CONSOLIDATED MODEL ALSO. I WAS ON THE PHONE YESTERDAY FOR QUITE SOME TIME WITH A GROUP OF ACADEMY INSTITUTIONS IN ANOTHER PART OF THE COUNTRY, THAT ARE LOOKING TO CONSOLIDATE. EIGHT OR NINE OF THEM TO CONSOLIDATE THEY'RE INFRASTRUCTURES SO THEY CAN PERFORM THEIR RESEARCH IN A VERY -- IN A WAY THAT'S MORE CONTINUE THAN THEY HAVE IN THE PAST AND THEY COULD ENCOURAGE AND INTEGRATE MORE RESEARCH INTO THEIR OVERALL CULTURE, WHICH, FOR MANY REASONS THEY HAVE TO SPLIT BETWEEN CLINICAL CARE AND RESEARCH. SO, I THINK THAT ACADEMIC CENTERS THAT ARE FORWARD-THINKING WILL BE ALSO AT THE FOREFRONT OF BEING EXTREMELY COMPETITIVE FOR NEW CARS CONTRACTS AND NEW OPPORTUNITIES. SO WHILE WE DIDN'T KNOW THE TRENDS SEVEN YEARS AGO WHEN THE CONTRACTS WERE FIRST BEING CONTEMPLATED AND WRITTEN UP, IT TAKES A YEAR TO GET A CONTRACT FROM CONCEPT OUT INTO THE FIELD AND AWARDED. WE ALSO DON'T WANT TO SAY THAT ACADEMIC INSTITUTIONS ARE IN ANY WAY EXCLUDED FROM THE NEW TYPES OF 21st CENTURY RESEARCH. ON THE CONTRARY, ACADEMIC INSTITUTIONS ARE ENCOURAGED TO ADAPT, DEVELOP, AND PARTICIPATE, AND MANY, MANY OF THEM HAVE AND QUITE EFFECTIVELY. THE NEXT QUESTION IS: WHY WERE THE HYPOTHESISES REMOVED FROM THE STUDY? WELL, WE HAD TO LOOK AT IT ON TWO LEVELS. THE FIRST IS THAT WE HAD A COLLECTION OF HYPOTHESISES THAT WAS BY ALL CONTEMPORANEOUS CONDITIONS -- CONDITIONS A SHOPPING WRIST OF WHEEL SAY, WHY DON'T YOU STUDY THIS OR THAT, AND WE HAD CLOSE TO 30 OF THEM, AND WHEN WE DID PROJECTIONS AS TO OUR ABILITY TO COLLECT ALL THE DATA TO ADDRESS EVERY ONE OF THOSE HYPOTHESES, WE CAME TO THE CONCLUSION THAT YOU COULDN'T DO IT WITH 100,000 CHILDREN YOU NEED MANY MORE, AND YOU COULDN'T DO IT WITH THE RESOURCES THE STUDY HAD. AS A MATTER OF FACT, THE HISTORY OF THE STUDY IS THAT TAKING THOSE HYPOTHESES AND EXTRAPOLATING THEM LED TO BUDGET PROJECTIONS WHICH WERE EYE-POPPING, AND WE'LL LEAVE IT AT THAT. SO, WHAT WE DID IS RECAST THE STUDY AND WE SAID, WHAT WE REALLY NEED TO DO NOW IS DEVELOP HYPOTHESES ABOUT DOING A STUDY, SO WE WROTE HYPOTHESES ON A STUDY DESIGNED TO UNDERSTAND METHODS, WE HAVE SPECIFIC HYPOTHESES IN THE STUDY. THEY HAVE BEEN REVIEWED AND DISCUSSED POSSIBLY, -- PUBLICLY, AND WE HAVE AN LITTIC PLAN TO LOOK AT THE RESULTS OF THESE HYPOTHESES. THE EXPOSURE-RESPONSE HYPOTHESES IN THE MAIN STUDY, HAVEN'T BEEN DEVELOPED YET. SO, ALL WE CAN SAY FOR SURE IS WHAT IS GOING ON IN THE VANGUARD STUDY. AS WE DEVELOP THE MAIN STUDY, WE WILL REVISIT AND PRIORITIZE THE APPROACH TO GATHERING INFORMATION FOR EXPOSURE RESPONSE RELATIONSHIPS. AND WE WILL USE THE SAME SYSTEMIC PROCESS THAT WE HAVE USED IN DEVELOPING OUR APPROACH TO RECRUITMENT, AND OUR APPROACH TO WHERE RECRUITMENT MIGHT OCCUR. SO, THE -- I KNOW I SHARE A LOT OF WORDS BUT WRIT -- WHERE IT COMES TO IS THAT HYPOTHESES ARE NOT REMOVED. WE SUBSTITUTED A SET OF HYPOTHESES THAT WERE RELEVANT THE VANGUARD STUDY AND PUT THEM IN PLACE, AND WHEN WE GET TO THE MAIN STUDY FOR EXPOSURE RESPONSE, WE WILL BEGIN AGAIN AND SEE WHERE THAT LEADS US. SO, STAY TUNED. >> I'M FROM MICHIGAN STATE UNIVERSITY. A POINT OF CLARIFICATION. BECAUSE I WOULD NOT WISH THIS AUDIENCE TO BE MISLED. I WAS CHAIR OF THE STUDY WORKING GROUP FOR FROM 2001 TO 2003. AND WE WERE THE ONES WHO ISSUED THE CALL FOR HYPOTHESES, THE STUDIES WORKING GROUP UNANIMOUSLY FELT THAT A STUDY HAD TO HAVE HYPOTHESES AND WE GENERATED 26, EACH OF WHICH WAS VETTED CAREFULLY FOR POWER, WAS VETTED CAREFULLY FOR RELEVANCE, IMPORTANCE TO CHILD HEALTH, AND THE POSSIBILITY IT COULD BE CONDUCTED IN A STUDY OF 100,000. MANY OF THEM DIDN'T NEED 100,000. I THINK YOUR DESCRIPTION OF THE PROCESS OF THOSE HYPOTHESES IS MISTAKEN, SIR, AND ILL INFORMED, AND I URGE EVERYONE TO GO BOOK THE HYPOTHESES, AND WHY THEY WERE PROPOSED AND WHY THEY WERE ADOPTED. THEY WERE NOT AS YOU DESCRIBED WHIMSICAL AND ILL CONSIDERED AND I DO NOT KNOW OF ANY OF THEM -- I'D LIKE YOU 0-POINT OUT TO ME THAT COULD NOT HAVE BEEN DONE WITHIN THE CONTEXT OF THE NATIONAL CHILDREN'S STUDY AT THAT TIME. QUITE A FEW OF THEM DIDN'T REQUIRE ANYTHING AS LARGE AS THE NATIONAL CHILDREN'S STUDY. BUT THE ONES THAT DID COULD HAVE BEEN DONE WITHIN OF THAT TIME FRAME. THANKS. >> THANK YOU FOR SHARING YOUR OPINION, AND I WILL NOTE THAT THERE ARE OTHERS WHO HAVE OTHER PERCEPTIONS, AND THE NATIONAL CHILDREN'S STUDY IS MANY THINGS TO MANY PEOPLE. WE HAVE ANOTHER QUESTION THAT SAYS: WE HAVE LOW CONTACT PARTICIPANTS. HAVE ANY DECISIONS BEEN MADE REGARDING THE ONGOING STATUS FOR THEM? WILL THEY CONTINUED TO BE FOLLOWED TO HELP GATHER DATA? AND THE RESPONSE IS, YES, WE WILL CONTINUE TO FOLLOW ALL OF THEM FOR THE NEXT COUPLE OF DECADES, AND WE ARE TRANSITIONING THE DATA COLLECTION SO THAT THE LOW CONTACT PARTICIPANTS WILL RECEIVE THE SAME QUESTIONNAIRES AS THE HIGH CONTACT PARTICIPANTS, AND THE DISTINCTION WILL BE WHETHER WE GATHER BIOLOGICAL SPECIMENS OR ENVIRONMENTAL SAMPLES. SO, FOR THE LOW-CONTACT PARTICIPANTS WE DO NOT PLAN TO GATHER BIOSPECIMENS OR ENVIRONMENTAL SAMPLES, BUT THE QUESTIONS ARE BEING TRANSITIONED SO IT WILL BE THE SAME SET OF QUESTIONS ACROSS THE ENTIRE STUDY COHORT. >> YES. >> GIVEN THE FACT THE CHILDREN'S HEALTH ACT WAS PASSED OVER TEN YEARS AGO, AND GIVEN THE FACT THAT ONE OF OUR WAYS OF TRYING TO KEEP THE COMMUNITY ENGAGED IS BY OFFING THEM THE PROMISE OF ANSWERS TO QUESTIONS THAT WE HAVE HAD SURROUNDING THE IMPACT OF THE ENVIRONMENT ON OUR CHILDREN'S HEALTH, HOW CAN WE COMMUNICATE WHAT SCIENTIFIC PROGRESS HAS BEEN MADE WITH THIS STUDY TO THE COMMUNITIES COMMUNITIES TO HE LP KEEP THEM ENGAGED? >> GREAT QUESTION. SO, I GET ASKED THAT QUESTION QUITE REGULARLY BY THE PEOPLE THAT PAY THE BILLS. WHAT HAVE YOU DONE IN THE LAST DECADE? AND SO WE HAVE, WE BELIEVE, AN IMPRESSIVE PORTFOLIO OF SCIENTIFIC RESULTS WHICH WE HAVE LEARNED PRIMARILY ABOUT THE METHODS OF DOING SCIENCE. WE HAVE NOT EMPHASIZED THE EXPOSURE RESPONSE RELATIONSHIPS WHICH LED TO THE CALL FOR THE STUDY, BUT WE HAVE MANY PAPERS UNDER DEVELOPMENT, MANY PAPERS ALREADY PUBLISHED, AND WE HAD SO MUCH MATERIAL THAT LESS THAN A YEAR AGO, WE FILLED THIS BUILDING WITH PRESENTATIONS AND POSTERS ON ALL THE FINDINGS FROM THE STUDY. BUT THEY HAVEN'T MADE HEADLINES IN GENERAL, NOR HAVE THEY AFFECTED THE HEALTH OF CHILDREN DIRECTLY, BUT ONLY INDIRECTLY, IN THAT THE ACTIVITIES WE HAVE BEEN EXPLORING AND IMPLEMENTING HAVE ALREADY RECEIVED ATTENTION AND BEEN ADOPTED BY OTHER STUDIES WHICH HAVE BUILT ON THESE METHODS. SO THE SHORT ANSWER IS THAT WE HAVE, WE BELIEVE, IMPROVED AND IN MANY CASES DEVELOPED AND INNOVATED APPROACHES TO DOING RESEARCH WHILE WE WERE ESTABLISHING THE MEANS AND THE FEASIBILITY TO DO A LARGE STUDY, AND WE BELIEVE WE HAVE ESTABLISHED THAT WE CAN DO SUCH A STUDY. SO THAT WAS AN IMPORTANT FINDING BY ITSELF. AND THEN WE HAVE ALL THESE OTHER TECHNICAL IMPROVEMENTS. WE HAVEN'T COME UP WITH THE NEW HEALTH MODELS BECAUSE OUR EFFORTS HAVEN'T BEEN ORIENTED TOWARD THAT YET. WHEN WE GO INTO THE MAIN STUDY WITH THE FOCUS ON EXPOSURE AND RESPONSE, THAT IS WHEN WE WILL BE ANTICIPATING AND OUR GOAL IS TO NOT WAIT 20 YEARS BUT TO BEGIN TO MAKE THOSE DATA AVAILABLE AND SHARE THEM AS SOON AS WE HAVE THEM. >> A FOLLOWUP ON THAT. I BELIEVE OUR ROLE IS A UNIQUE ROLE AND YOU HAVE ARE PARTICULAR -- ARTICULATE IT THAT THIS MORNING -- THIS AFTERNOON. HOW CAN WE TRANSLATE THAT SCIENCE SO THAT THE EVERYDAY PERSON WHO IS GOING TO READ A SHORT ARTICLE IN THE NEWSPAPER RATHER THAN A JOURNAL, WILL UNDERSTAND THE VALUE, AND THEN ON TOP OF THAT, YOU MENTIONED THAT YOUR BOSSES -- I ASSUME THAT'S THE APPROPRIATORS OF THE FUND -- I WONDER WHAT KIND OF ROLE WE CAN HAVE IN ASSISTING AND SUPPORTING OR EVEN ACCELERATING CONGRESSIONAL AWARENESS AND SUPPORT AND CONTINUED FUNDING OF THIS. >> WE HAVE TO STAY OUT OF ANY ENCOURAGEMENT OR INSTRUCTIONS TO INFLUENCE FUNDING OR AWARENESS OR SO FORTH. WE HAVE TO TAKE A PASSIVE ROLL AND RESPOND CONTINUE CREASE AND UPDATES. SO WE'RE REQUESTS ON A FAIRLY PREDICTABLE SCHEDULE THAT COINCIDES WITH THE BUDGET DEVELOPMENT PROCESS ABOUT INFORMATION AND UPDATES AND THEN I, AND THEN THE PEOPLE I REPORT TO ARE THEN OFTEN CALLED TO TESTIFY IN PERSON OR BRIEF VARIOUS GROUPS AND WE PROVIDE INFORMATION THROUGH THAT MEANS PRIMARILY. IN TERMS OF ON A LOCAL LEVEL, I THINK WHAT WE WOULD LIKE TO HAVE OCCUR IS THAT WE PREPARE MATERIALS BUT ALSO WE WOULD ENCOURAGE YOU TO EITHER SUGGEST MATERIALS OR PREPARE MATERIALS, BECAUSE YOU'RE ON THE INSIDE NOW. TO CONVEY THE SCOPE OF ACTIVITIES AND CONVEY THE PHILOSOPHY AND APPROACHES TO THE WAY WE PERFORM SCIENCE AND THE VALUES WE BRING TO SCIENCE. AS WE GO FURTHER IN THIS ENTERPRISE, WE WILL HAVE SPECIFIC RESULTS THAT IN SOME CASES MIGHT BE FOCUSED ON A PARTICULAR COMMUNITY, AND COMMUNITY CAN BE BROADLY DEFINED. DOESN'T NECESSARILY HAVE TO BE A GEOGRAPHIC AREA. IT COULD MEAN PEOPLE WHO ARE CULTURALLY UNITED, PEOPLE WHO ARE, THROUGH INTERESTS OR THROUGH ETHNICITY OR THROUGH SPIRITUALITY, MANY DEFINITIONS OF COMMUNITY, BUT WE WOULD ENCOURAGE YOU TO IDENTIFY COMMUNITIES, IDENTIFY ISSUES RELATED TO COMMUNITIES, AND HELP US COMMUNICATE BOTH WAYS. >> I JUST HAVE A FOLLOWUP FROM A QUESTION A COUPLE QUESTIONS AGO. AND THEN JUST KIND OF GOT MY WORDS TOGETHER. YOU RESPONDED TO A QUESTION AROUND THE TRANSITION OF -- OR POTENTIAL TRANSITION OF CONTRACTORS AND THEIR RELATIONSHIP WITH PARTICIPANTS AND HOW TO TRANSITION THAT IN A WAY THAT KEEPS PARTICIPANTS ENGAGED. ONE OF THE CONCERNS I HAVE -- AND I KNOW THAT BOTH AT THE LOCAL LEVEL HAVE EXPRESSED CONCERN, TOO -- IS THOSE RELATIONSHIPS BUILT NOT WITH PARTICIPANTS BUT OTHER COMMUNITY LEADERS, ORGANIZATIONS, THOSE WHO THEY HAVE THE REALLY PUT THEMSELVES ON THE LINE TO RECRUIT TO BE PART OF LOCAL CABS, TO BE INVOLVED IN THE STUDY, AND SO THERE'S A LITTLE BIT OF A CONCERN ABOUT IF THERE'S A TRANSITION AND THEY HAVE SPENT THIS-I GUESS FOR LACK OF A BETTER WORD, POLITICAL CAPITAL WITH THESE COMMUNITY LEADERS, HOW DO YOU SEE THE EFFECT OF THAT ON -- IF WE TRANSITION TO A DIFFERENT ORGANIZATION THAT THEN TAKES OVER IN THAT COMMUNITY OR IF WE LOOK AT SOMETHING ON A LARGER SCALE WITH REGIONAL ORGANIZATIONS. AND I DON'T KNOW IF IT'S A COMMENT OR A QUESTION BUT I WANT TO SEE WHETHER THE PROGRAM OFFICE COULD HAVE SOME FEEDBACK ON HOW TO ADDRESS THAT. >> RIGHT. ABSOLUTELY. SO, WE EXPERIENCE THAT ON MANY LEVELS AT THE NATIONAL INSTITUTES OF HEALTH AND WE EXPERIENCE THAT MANY LEVELS IN OUR AREAS OF MEDICAL INTERESTS OR TRAINING. I'M MOST FAMILIAR WITH THE COMMUNITIES AND THE LEADERS AND THE DYNAMICS IN THE WORLD OF ONCOLOGY, CANCER, AND WE HAVE ORGANIZATIONS THAT CHANGE LEADERSHIP EVERY YEAR. SOME CHANGE EVERY OTHER YEAR. WE HAVE ORGANIZATIONS THAT INTERACT WITH ELECTED OFFICIALS, AND ELECTED OFFICIALS CHANGE REGULARLY. WE HAVE ORGANIZATIONS THAT INTERACT WITH OTHER ORGANIZATIONS, AND WE HAVE PEOPLE THAT ARE AT VARIOUS STATEMENTS IN -- STAGES OF THEIR LIVES AND THE IMPORTANCE OF THE ENTERPRISE ADJUSTS TO THEIR OWN PERSONAL PRIORITIES. SO MY PERSONAL VIEW IS THE WORLD IS ALWAYS IN FLUX AND YOU ALWAYS NEED TO BE FOLLOWING ADVICE OF THE ENGLISH WRITER OF ANOTHER CENTURY, SAMUEL JOHNSON, WHO SAID, YOU KEEP YOUR FRIENDSHIPS OR, IN THIS CAKES ALLIANCES IN GOOD REPAIR, AND WE WOULD EXPECT, AND WE WOULD SUPPORT, THAT IF THERE ARE KEY RELATIONSHIPS THAT PEOPLE TAKE THE RESPONSIBILITY TO EFFECT A TRANSITION. TO MAKE THE INTRODUCTIONS, AND WE KNOW OVER THE COURSE OF FIVE YEARS, WHILE ANY TEAM IS IN PLACE, THAT THERE WILL BE WITHIN THAT SPHERE OF INFLUENCE MANY TRANSITIONS ALSO. SOME PARTS OF THE COUNTRY HAVE RELATIVE STABILITY BUT MOST PARTS ARE VERY DYNAMIC IN TERMS OF WHO IS RUNNING ORGANIZATIONS, WHO IS -- WHO ARE ELECTED OFFICIALS AND SO FORTH. CAN LOOK AT SPORTS TEAMS AND THE TURNOVER THERE AND SO FORTH. SO, I THINK WE HAVE TO TAKE AN APPROACH THAT PEOPLE INVEST PERSONAL AND POLITICAL CAPITAL BUT THAT'S AN ONGOING PROCESS. AND YOU NEED TO MAKE YOUR OWN INVESTMENTS ONGOING IN ORDER TO MAINTAIN THE RETURNS ON THOSE INVESTMENTS. >> DR. HIRSCHFELD YOU SPOKE ABOUT YOUR INTERACTION WITH CONGRESS. COULD YOU GIVE US A QUICK SNAPSHOT ABOUT THEIR THOUGHTS ABOUT THE NATIONAL CHILDREN'S STUDY? >> THERE ARE 435 REPRESENTATIVES AND 100 SENATORS, AND THE MOST I'VE EVER MET WITH AT ONE TIME WAS ABOUT 10. OKAY? AND IT'S SOMETIMES LIKE GOING TO MEETINGS WHERE THERE'S TEN INDIVIDUALS AND 0 -- 30 OPINIONS. SO I JUDGE THE RECEPTIVITY BY TWO CRITERIA. FIRST, DO THEY GIVE US AN APPROPRIATION OR NOT TWO YEARS AGO THAT WAS SERIOUSLY IN DOUBT. WHETHER WE WOULD HAVE A STUDY WAS MAJOR QUESTION. AND IF WE WOULD HAVE A STUDY, WOULD IT BE SUPPORTED AT A LEVEL THAT WOULD BE CONSISTENT WITH THE VISION FOR THE STUDY? ALL THAT WAS IN DOUBT. BUT WE SURVIVED THAT. SO THAT'S AN IMPORTANT ENDORSEMENT. AND WE HAVE HAD CHANGES IN ADMINISTRATION, WE HAVE HAD CHANGES IN THE COMPOSITION OF THE TWO HOUSES OF CONGRESS AND WE STILL SURVIVE. WE HAVE CHAMPION IN BOTH THE HOUSE AND THE SENATE AND PEOPLE WITH DIFFERENT PHILOSOPHIC DIFFERENCES WITH THE ENTIRE CONCEPT OF DATA COLLECTION AND BASING POLICY ON ANALYSIS OF DATA. SO THERE'S A SPECTRUM. MY ONLY PERSPECTIVE IS THAT I MUCH PREFER TO BO BE IN THE SHADOWS AND NOT THE SPOTLIGHT, AND I PREFER THAT PEOPLE LOOK AT WHAT WE DO AND HOW WE DO IT AND LOOK AT THE RESULTS WE DELIVER, AND MAKE A JUDGMENT. SO, I CAN'T BE MORE SPECIFIC BECAUSE WE DON'T DO SURVEYS OR SOLICIT OPINION. WE JUST RESPOND TO PEOPLE. BUT I CAN SHARE WITH YOU THAT WHEN I, AND THE PEOPLE I REPORT TO DO HAVE THE OPPORTUNITY TO EXPLAIN FACE-TO-FACE WITH ANY ELECTED REPRESENTATIVES ABOUT THE STUDY, WE INVARIABLY FIND THAT PEOPLE ARE POSITIVE, THAT THEY ARE SUPPORTIVE AND ENCOURAGING, AND THEY MAY NOT COME INTO THE CONVERSATION THAT WAY. AND IT'S NOT A REFLEX ON ME OR THE PEOPLE I REPORT TO. I THINK IT'S A REFLEX ON UNDERSTANDING THE STUDY AND SEPARATING WHAT THE STUDY IS ABOUT FROM WHAT THEY MIGHT HEAR ABOUT THE STUDY. AND I THINK THAT WHEN WE HAVE PEOPLE WHO TAKE THE TIME AND TROUBLE TO WANT TO LEARN ABOUT THE STUDY, THAT'S THE MOST CRITICAL FIRST STEP, AND ONCE THEY OPEN UP THEIR EARS, WE FIND THAT SUPPORT IS NOT A QUESTION FOR US. >> I HAVE TWO MORE QUESTIONS HERE I'D LIKE TO ADDRESS AND THEN WE WILL COME BACK TO YOU. I'LL DO ONE OF THE QUESTIONS AND THEN WE'LL GO TO YOU. OKAY? SO ONE QUESTION IS, HOW DO WE ENCOURAGE RELATIONSHIPS WITH PAR TIS PAINTS IF WE DISMANTLE WHAT IS IN PLACE AND HAVE TO START WITH A NEW ENTITY? ALSO, YOU MENTIONED LOCAL COMMUNITY ADVISORY BOARDS WORKING WITH LOCAL REGIONAL COMMUNITY ADVISORY BOARD. WHAT WOULD MOTIVATE US TO STAY WITH AN ADVISOR WITH A NEW CONTRACTOR IF OUR ORIGINAL LOCAL STAFF COMMITTED TO THE STUDY, OUR PARTICIPANTS AND COMMUNITY-AREN'T INVOLVED? >>> SO WE RECOGNIZE THAT MANY OF THE COMMUNITY ADVISORY BOARDS -- IN FACT ALL OF THEM WERE SELECTED BY CONTRACTORS, AND IT'S ABSOLUTELY UNDERSTANDABLE THAT IF SOMEONE SCHRECKS -- SELECTS YOU AND SAYS, LET'S WORK TOGETHER, THERE'S AN ANTICIPATION OF WORKING TOGETHER. WHAT WOULD WE WOULD ADVISE IS THE SAME WAY WE ENCOURAGE RELATIONSHIPS IN ALL OF THE OTHER ACTIVITIES AROUND THE STUDY. NOW, DISMANTLE WHAT IS CURRENTLY IN PLACE. I'D LIKE TO ELABORATE ON THAT. WE SAID A COUPLE YEARS AGO THAT WE WOULD LIKE TO LEARN HOW BEST TO DO A STUDY, AND WE WANTED TO ENGAGE AND BUILD ON THE EXPERTISE THAT ALL THE VARIOUS FIELD CONTRACTORS HAD. SO, WE ASKED PEOPLE TO SHOW US HOW THEY WOULD IMPLEMENT THE STUDY -- HAD TO BE THE SAME PROTOCOL. COULDN'T CHANGE THE PROTOCOL. BUT WE GAVE, WE FELT, GREAT LATITUDE IN LOCAL IMPLEMENTATION, AND THAT WAS IMPORTANT, BECAUSE WE LEARNED MANY THINGS, AND IF WE HAD DONE OR TRIED TO DO EVERYTHING THE SAME, WHICH WE DID DO FOR ABOUT A YEAR AND A HALF, I DON'T THINK WE WOULD HAVE LEARNED AS MUCH AS QUICKLY. SO, AMONG OTHER VARIATIONS IS WE ASK PEOPLE TO DO RECRUIT INDEPENDENT THREE DIFFERENT WAYS. WE ASK PEOPLE TO RECRUIT ON THE BASIS OF KNOCKING ON DOORS. WE ASK PEOPLE TO RECRUIT BY DIRECT OUTREACH INTO THE COMMUNITY. AND WE ASK PEOPLE TO RECRUIT THROUGH WHAT WE BELIEVE TO BE TRUSTED INDIVIDUALS, WHICH WERE HEALTHCARE PROVIDERS, AND SPECIFICALLY PRENATAL HEALTHCARE PROVIDERS. AND WE LEARNED MUCH FROM HAVING ALL THOSE DIFFERENT APPROACHES OCCUR. BUT WE CAN'T BUILD A LONG-TERM SUSTAINABLE SOLUTION USING MULTIPLE APPROACHES. SO, WE HAVE TO CONSOLIDATE AND SAY, WHAT IS IT THAT SEEMED TO FUNCTION BEST IN WHAT CIRCUMSTANCE? SO, THAT DOESN'T MEAN THAT EVERYONE HAS EXACTLY THE SAME IMPLEMENTATION PLAN, BUT IT MEANS WE WILL PRIORITIZE THOSE ACTIVITIES THAT PROVE TO BE EFFECTIVE ON MANY CRITERIA, AND WE WILL LET GO THOSE PRACTICES AND THOSE PROCESSES THAT WERE NOT EFFECTIVE. I'LL GIVE YOU A CONCRETE EXAMPLE. IF WE WERE COLLECTING DATA, WE HAD A BLEND OF DIFFERENT KINDS OF INFORMATION SYSTEMS AND WE ASKED ALL THE SYSTEMS TO FEED INTO A CENTRAL DATABASE ACCORDING TO SOME SPECIFICATIONS, AND SOME FUNCTIONED WELL AND SOME WERE CHALLENGED TO DO THAT. SO WEAPON WENT FORWARD WITH THOSE SYSTEMS THAT SEEMED TO FUNCTION WELL AND MET CERTAIN CRY TIERA, AND WE WILL NOT DEVELOP ANY FURTHER OR SUPPORT IN THE NATIONAL CHILDREN'S STUDY FOR THE LONG-TERM SOME OF THE OTHER SYSTEMS. SO, WE DON'T VIEW WHAT WE ARE DOING AS DISMANTLING. WE VIEW IT AS CONSOLIDATING BEST OF BREED. BRINGING TOGETHER THOSE SOLUTIONS THAT SEEM TO FUNCTION WELL ASK TRYING THEM IN NEW COMBINATIONS TO GET EVEN BETTER FUNCTIONALITY, AND WE ANTICIPATE AND EXPECT THAT THIS WILL BE AN ONGOING PROCESS DURING THE NATIONAL CHILDREN'S STUDY VANGUARD, THAT WE'LL ALWAYS BE MAKING ADJUSTMENTS AND CHANGES, AND EVEN IN THE MAIN STUDY WE EXPECT THERE WOULD BE ONGOING, ALTHOUGH NOT WITH THE RAPIDITY OR THE SCOPE THAT IT WOULD BE IN THE MAIN STUDY. SO, FOR US, IT'S NOT STARTING NEW, IT'S TRANSITIONING FROM SOMETHING WE KNOW TO SOMETHING THAT WE BELIEVE MAY FUNCTION BETTER AND WE WANT TO ESTABLISH IF THAT'S THE CASE OR NOT. >>> IN TERMS OF WORKING WITH THE REGIONAL COMMUNITY ADVISORY BOARDS, THE MOTIVATION TO STAY ON AS AN ADVISOR WOULD BE A COMMITMENT TO THE STUDY AS A NATIONAL STUDY, CURIOSITY, INTEREST IN THE HEALTH OF CHILDREN, AND A WILLINGNESS TO HAVE YOUR VOICE HEARD, AND I THINK THERE ARE OTHER FACTORS, BUT I WOULD SAY THOSE WOULD BE IMPORTANT FACTORS TO CONSIDER MOVING FORWARD. I THINK THE NATIONAL CHILDREN'S STUDY IS A UNIQUE ENTERPRISE. WE'RE UNAWARE OF OTHER STUDIES OF THIS SCALE WITH THIS TYPE OF MISSION IN THIS COUNTRY, AND I THINK TO BE PART OF THAT HISTORY, TO PLAY SOME ROLE IN THE FUTURE OF THE STUDY, IS AN OPPORTUNITY. SO I WOULD SAY, ANYONE THAT WOULD LIKE TO ENGAGE IN AN OPPORTUNITY TO BE PART OF A NATIONAL ENTERPRISE THAT IN MANY WAYS WILL INFLUENCE CHILDREN FOR MANY YEARS TO COME. >> YOU HAD A QUESTION? >> YES. AS AN EXAMPLE OF THE PERSPECTIVE THAT SOMEONE OUTSIDE THE RESEARCH PROCESS CAN BRING TO THIS, THIS MORNING WHEN DR. ED CLARK FROM THE UNIVERSITY OF UTAH, WAS TALKING ABOUT HOW HE WAS HELPING TO FACILITATE THE TRANSITION OF DATA FROM THEIR VANGUARD STUDY TO THE INTERIM CONTRACTOR, THE THING THAT DISTRESSED ME WAS, WHEN WE TALKED ABOUT BEING ABLE TO REENROLL PEOPLE FOR THE ONGOING STUDY, AND TO ME, MY QUESTION IS, ISN'T THERE A WAY TO LEGALLY CONSTRUCT A CONSENT PROCESS WHERE EVERYTIME A CONTRACTOR CHANGES, YOU WOULDN'T HAVE TO ENROLL PARTICIPANTS INTO THE STUDY? HE WAS PRETTY EXCITED THEY HAD ALREADY RECONSENTED 60% OF THEIR ORIGINAL PIER -- PARTICIPANTS HE EXPECTED THEY WOULD BE ABLE TO INCREASE THAT NUMBER, BUT IN MY OPINION, I WAS DISTRESSED. I FELT LIKE ALL THE WORK THAT HAD GONE INTO ENROLLING THOSE INITIAL PARTICIPANTS, IF THIS HAPPENS POTENTIALLY EVERY FIVE YEARS, WHEN THERE'S A NEW CONTRACTOR, THAT'S NOT A GOOD TRACK RECORD. >> I THINK WE'RE IN ABSOLUTE AGREEMENT THERE. SO, WE HAVE, IN OTHER NIH PROGRAMS, EXPERIENCE WITH THIS TRANSITION. LET ME GO TO YOUR FIRST QUESTION. CAN WE LEGALLY SET UP A PROCESS WHERE PEOPLE WOULD CONSENT ONCE AND THAT WOULD BE IT? LIFETIME CONSENT, SO TO SPEAK. AND UNDER OUR CURRENT FRAMEWORK, WE CAN'T DO THAT. BELIEVE ME. WE DON'T WANT TO GO OUT AND HAVE TO PUT THE RESOURCES INTO RECONSENTING. BUT THE PROTOCOLS CHANGING. THE IMPLEMENTATION IS CHANGE AND SO FORTH, AND WE ARE IN A REGULATORY FRAMEWORK WHERE PARTICIPATION IS GOVERNED BY THE LOCAL AUTHORITIES. SO, THE LOCAL AUTHORITIES COULD WITH WAIVE THAT IF THEY WISH TO BUT WE DON'T EXPECT THEM TO AND WE OPERATE AS IF WE RESPECT THEIR AUTHORITY AND WILL GO FORTH AND DO THAT RECONSENT. I THINK THE KEY NUMBER OF THE NUMBERS WAS THE 1% THAT DIDN'T WANT TO GO FORWARD, AND THAT'S ACTUALLY LOWER THAN WE THOUGHT. SO, I'M ENCOURAGED BECAUSE WE HAVE TALKED TO PEOPLE WHO DO STUDIES GOING BACK TO THE 1940s, WHO HAVE DONE LONGITUDINAL STUDIES. AND I ASKED THEM WHAT THEY'RE EXPERIENCE IS AND IT VARIES, BUT IN GENERAL, PEOPLE HAVE THEIR LARGEST LOSS OF PARTICIPANTS IN THE FIRST FEW YEARS, AND THEN AFTERWORDS REACH SOME KIND OF A STEADY STATE, DEPENDING ON HOW LONG THE STUDY IS, OF COURSE, WHERE THEY CAN GET TO ABOUT 2% LOSS PER YEAR. WE CALL IT ATTRITION. OUR INSTITUTE HAS RUN STUDIES WHERE WE FOLLOW POPULATIONS FOR LONG PERIODS OF TIME, AND IF WE CAN HOLD TO 2% A YEAR, WE FEEL WE'RE DOING FAIRLY WELL. IF IT GETS HIGHER THAN THAT, WE HAVE TO ASK QUESTIONS. THAT'S WHY WE INSTITUTED A RETENTION COLLABORATIVE IMPROVEMENT NETWORK AS WELL AS OTHER ACTIVITIES GEARED AT RETENTION, TO STUDY THAT, AND WHAT WE WILL LEARN FROM THESE EARLY TRANSITIONS IS WHAT SEEMS TO BE EFFECTIVE AND WHAT DOES NOT. WE UNDERSTAND IN EVERY CASE THERE ARE LOCAL CONSIDERATIONS, AND WE HOPE TO LEARN FROM EVERYBODY THAT DOESN'T PARTICIPATE IN THE STUDY WHY. IT'S IMPORTANT TO US TO KNOW THAT. WE WANT TO KNOW WHEN WE FIRST APPROACH SOMEONE, AND THEY DECIDE NOT TO PARTICIPATE -- WE HAVE A SEPARATE QUESTIONNAIRE, CAN WE ASK YOU ONE OR TWO MORE QUESTIONS? WHEN WE PROVIDE A HEALTHCARE PROVIDER AND SAY, WOULD YOU BE WILLING TO ACT AS A FACILITATOR IN THE STUDY, COULD WE USE YOUR PREMISES TO RECRUIT FROM? AND IF THEY SAY, NO, WE WANT TO KNOW WHY. BECAUSE WE THINK WE COULD LEARN AND IMPROVE FROM THAT PROCESS. SO, IN SHORT, WE DON'T HAVE THE REGULATORY FLEXIBILITY. AT LEAST NOW, BUT WE HOPE TO LEARN FROM THE PROCESS, AND MAYBE IN THAT PROCESS WE CAN IMPROVE OUR LONG-TERM RETENSION AS WE GO FORWARD. >> GEORGE LISTER, UT SOUTHWESTERN. IF I CAN TAKE YOUR ANALOGY OR METAPHOR AND TAKE IT ONE STEP FURTHER, THERE'S NO QUESTION, FOR EXAMPLE IN ONCOLOGY THERE MIGHT BE A CHANGE IN SOMEBODY WHO LEADS A GROUP OF CHILDREN'S ONCOLOGY NETWORK OR WITH THE NCI, AND A PATIENT WILL BE PRETTY FORGIVING AND UNDERSTANDING OF THAT BUT IS A LITTLE LESS FORGIVING OR UNDERSTANDING OR TOLERANT OF THE CHANGE IN ONES ONCOLOGY GIST BECAUSE THERE'S A PERSONAL RELATIONSHIP. I DON'T WANT TO OVERDRAMATIZE THIS BUT I THINK THE RISK WE'RE DEALING WITH ARE THE PERSONAL RELATIONSHIPS BUILT UP OVER THE PAST FEW YEARS AND THAT'S REALLY WHAT SUSTAINED OUR ABILITY TO GO INTO THE COMMUNITY, AND THE CONCERN I HAVE ARE THE RIPPLES, NOT JUST FOR THIS STUDY BUT FOR OTHERS BECAUSE IN MANY AREAS WE HAVE TAKEN A FRESH FOOT PRINT INTO A COMMUNITY, WHICH IS ARGUABLY A FOOTPRINT THAT ALLOWS MANY OTHER TYPES OF COMMUNITY-BASED STUDIES AND I THINK THAT'S AN AREA THAT YOU'RE CERTAINLY NOT BLIND TO, BUT THAT IS REALLY IMPORTANT TO THINK ABOUT AS WE MANAGE THAT, AND THERE ARE SUBTLETIES FOR GROUPS NEVER BEEN INVOLVED IN RESEARCH, AS A SUBJECT OR FRANKLY AS A PROVIDER WHO IS GIVING US ACCESS TO THEIR PATIENTS WHO WOULD BE SUBJECTS. >> I THINK THOSE ARE GREAT POINTS, AND WE HOPE TO REMAIN IN AND ADDRESS SENSITIVITY TO THAT WHOLE QUESTION OF RELATIONSHIPS. OFFLINE WE CAN DISCUSS THE RELATIONSHIPS THAT FORM IN ONCOLOGY BECAUSE THOSE ARE VERY SPECIAL RELATIONSHIPS, AND I WILL STILL SAY I'M IN TOUCH WITH FAMILIES, 20 YEARS LATER, THAT I SAW AS A MEDICAL STUDENT. WE HAVE A QUESTION THAT CAME IN. IT'S A LITTLE LONG. I'LL DO MY BEST TO READ IT ACCURATELY. I HAVE SEEN OUR ILLINOIS GATED EMPLOYS HAVE GONE THE COMMUNITIES AND COUNTIES THEY'RE IN. AND THEY HAVE DONE A FANTASTIC JOB OF MARKETING THE IMPORTANCE OF THE STUDY AND THE IMPORTANCE OF AN ACTIVE COMMUNITY IN SUPPORT OF THE STUDY. THESE PEOPLE HAVE DEVELOPED RELATIONSHIPS IN THE COMMUNITY AND BUILT TRUSTS WITH MEMBERS OF AND GROUPS IN THE COMMUNITY. WHILE I AGREE THAT CHANGE IS SOMETIMES PRODUCTIVE AND HELPFUL IT IS NOT ALWAYS NECESSARY. THE FAMILIES PARTICIPATE IN THE STUDY ARE ALLOWING OUTSIDERS INTO THEIR HOMES TO FOLLOW THEIR CHILDREN AND MAKING A HUGE COMMITMENT OF TIME INTO THEIR PRIVATE LIVES. THE COMMUNITY HAS GROPE TO -- HAS GROWN TO RECOGNIZE THE FACES OF THE STUDY FOR OUR AREA. SO MY QUESTION IS, ARE FAMILIES TOLD FROM THE BEGINNING THAT POSSIBILITY EXISTS THAT THE CORE PEOPLE THEY DEFENDANT WITH IN THE STUDY COULD POTENTIALLY CHANGE EVERY FIVE YEARS? I ASKS THIS BECAUSE USING THE COMPARISON TO CHILDREN CHANGING SCHOOL TEACHERS ISN'T NECESSARILY THE SAME. THERE'S AN UNDERSTANDING AND NORMAL PRACTICE THE WHICH CHILDREN CHANGE TEACHERS FOR A VARIETY OF REASONS, GROWTH OF THE CHILD, SPECIALTY FIELDED OF THE TEACHER. ADDITIONALLY CHILDREN WILL BE BUILDING BONDS WITH RESEARCHER FOR A FIVE YEARS, ONLY TO STANDARD OVER AGAIN IN ANOTHER FIRM AS THAT FIRM LOSES THE CONTRACT. HOW IS THAT THE SAME AND HOW DOES THAT ENCOURAGE A CHILD TO BUILD A NEW BOND? I THINK THIS GOES AGAIN TO THE FUNDAMENTAL NATURE OF BUILDING RELATIONSHIPS AND SETTING EXPECTATIONS. I THINK WE AS AN ENTERPRISE WERE REMISS WE DIDN'T INITIALLY INFORM PEOPLE THERE'S A POSSIBILITY THERE COULD BE A TURNOVER, BUT WE LEARNED, AND WE WILL, I THINK, GO FORWARD, CLEARLY, WITH THAT MESSAGE. NOW, THE NATURE OF RESEARCH AND ALSO THE NATURE OF CLINICAL CARE AND ACADEMIC CENTERS IS THAT THE FACES DO KEEP CHANGING. AND I KNOW FROM MY OWN LIMITED EXPERIENCE IN OBSTETRICS YOU CAN HAVE SOMEONE YOU SEE IN THE PERSON BUT THE PERSON WHO IS THERE AS A DELIVERIE IS A PERSON WHO IS PARTNER OF OR YOU HAVEN'T MET BEFORE OR YOU END UP IN ANOTHER LOCATION YOU WEREN'T PLANNING ON BEING, AND YOU ACCEPT THAT PERSON BECAUSE OF THE SKILL THEY HAVE AND BECAUSE OF THE SITUATION YOU'RE IN. NOW, RESEARCH IS VOLUNTARY. AND PARTICIPATING IN RESEARCH, WE VIEW, AS A GIFT, AND WE ARE RECEIVING A GIFT. SO WE NEED TO HONOR AND RESPECT HOW THAT GIFT WAS GIVEN, AND WE HAVE TO HONOR AND RESPECT THE PEOPLE THAT PROVIDE THAT GIFT TO US. SO, WHAT WE NEED TO DO IS SET THE EXPECTATION THAT EVERYONE'S PART OF THE TEAM, EVERYBODY HAS RECEIVED THE SAME TRAINING. EVERYONE HAS AN EQUALLY PASSIONATE COMMITMENT TO THE STUDY AND THAT EVERY OPPORTUNITY TO MEET SOMEBODY IS AN OPPORTUNITY TO LEARN SOMETHING NEW ALSO, AND, AGAIN, WE RETURN TO, AS INDIVIDUALS, WE HAVE ENCOURAGEMENT OF BUILDING BONDS AND RELATIONSHIPS BUT AS A STUDY ENTERPRISE WE HAVE TO, I THINK, PROSPECTIVELY ACTIVELY INFORM PEOPLE THAT THEY ARE A TEAM, AND IT'S THE SAME WHEN WE WORK IN ACADEMIC MEDICINE AND WE WORK AS TEAMS AND THERE ARE PEOPLE THAT COVER FOR US AND WE ROTATE OFF SERVICE AND SOMEONE ELSE FOLLOWS THROUGH, AND WE SOMETIMES CHANGE INSTITUTIONS AND OTHER PEOPLE COME IN, AND I VIEW THAT MORE AS A REFLECTION OF THE DYNAMIC NATURE OF SOCIETY IN THE 21st 21st CENTURY. SO, I THINK WE HAVE TO POSITION AND COMMUNICATE THAT WE ARE A TEAM, WE ARE A NATIONAL TEAM, AND THAT EVERY MEMBER OF THAT TEAM HAS TO REACH OUT AND DEMONSTRATE TO THE PEOPLE WE INTERACT WITH THAT WE VALUE AND RESPECT THEM. AND I THINK IF THEY SHOW THAT THEY VALUE AND RESPECT THE PEOPLE THEY'RE ENTER ACTING WITH, THAT THAT'S PROBABLY THE MOST EFFECTIVE WAY THAT WE HAVE IN ORDER TO BUILD ON A SERIES OF RELATIONSHIPS AS WE GO FORWARD. CARL HILL. >> THIS IS A FOLLOWUP COMMENT. IN TERMS OF MOVING FORWARD WITH THE VANGUARD STUDY, THE REGIONAL COMMUNITIMENT ENGAGEMENT ADVISORY COMMITEY WHILE BE TASKED WITH TAKING INVENTORY OF COMMUNITY ENGAGEMENT IN THESE STUDY LOCATIONS. SO, IN TERMS OF TAKING ADVANTAGE OR CONTINUING RELATIONSHIPS THAT HAVE WORKED IN THE PAST, IT WOULD BE UP TO THAT COMMITTEE IN THEIR TAKING INVENTORY, I'M SURE THESE RELATIONSHIPS WILL BECOME QUITE EVIDENT, THAT THEY SHOULD CONTINUE IN SOME CAPACITY WITH THE NATIONAL CHILDREN'S STUDY, VANGUARD STUDY, AND MOVING FORWARD. SO THE DESIGN IS TO TAKE ACCOUNT OF THESE RELATIONSHIPS AND POTENTIALLY CONTINUE THOSE, PARTICULARLY THOSE THAT HAVE WORKED. >> I'D LIKE TO BUILD ON THAT WITH WHAT WILL BE THE LAST QUESTION BECAUSE I GOT A NOTE THAT THE VIDEO CAST IS ABOUT TO BE TURNED OFF. SO, THE LAST QUESTION IS, NO DISRESPECT, SIR, HOWEVER I FEEL THE LOCAL STAFF IN OUR COUNTY AND PROBABLY MOST COUNTIES, HAVE DONE AN AMAZING JOB IN RECRUITING, RETAINING AND BUILDING RELATIONSHIPS. IN MY OPINION YOU ALREADY HAVE GREAT TEAMS TO CONTINUE THIS IMPORTANT STUDY. SO, WE'LL ACKNOWLEDGE AND EVEN AGREE, AND SO WHAT WE WOULD SAY IS THAT WHEN THE CONTRACT OPPORTUNITIES COME UP, THAT WE HAVE COMMUNICATED OVER AND OVER AGAIN THAT EVERYONE WHO IS IN THE FIELD NOW AND HAS A CONTRACT, IS ELIGIBLE TO COMPETE FOR NEW CONTRACTS AND THERE ARE MULTIPLE WAYS PEOPLE CAN BE ENGAGED IN NATIONAL CHILDREN'S STUDY. ONE IS AS A PRIMARY DATA COLLECTOR THIS, CURRENT CONTRACTS. THE OTHER WAY IS AS PARTNER OF THE PRIMARY DAT COLLECTOR. EYE WAY IS TO REMAIN INVOLVED AND ANALYZE THE DATA THAT COMES. NOW, THAT IS THE DISTANCE BECAUSE THEN YOU DON'T HAVE THOSE RELATIONSHIPS IN A DIRECT WAY. AND YET ANOTHER WAY IS TO OBTAIN OTHER FUNDING AND PARTNER WITH THE NATIONAL CHILDRENS STUDY THROUGH OUR ANCILLARY STUDY PROGRAM. SO, THERE ARE AT LEAST FOUR MECHANISMS BY WHICH INDIVIDUALS, TEAMS, INSTITUTIONS, AND ORGANIZATIONS, CAN PARTICIPATE IN THE NATIONAL CHILDREN'S STUDY AND WE SHOULDN'T VIEW THE PRIMARY DATA COLLECTION CONTRACT AS THE ONLY MECHANISM TO BE ENGAGED. THERE ARE MANY WAYS TO BE ENGAGED. AND I WANT TO THANK OUR PANEL HERE FOR THEIR ENGAGE. -- 0, SIR, PLEASE. >> AS MUCH AS YOUR THANKING US, WE WANTED TO TANK YOU. WE DIDN'T UNDERSTAND WHAT A TOWN HALL WOULD MEAN AND BASED ON THE NUMBER OF QUESTIONS AND THE CONTENTS AND THE QUALITY AND THE OPENNESS, WE WOULD LIKE TOO SUGGEST THAT THIS BECOME AN ANNUAL EVENT BETWEEN US AND YOU AND THE PUBLIC THAT WANTS TO BE INVOLVED. >> OH, THAT'S A LITTLE LESS THAN I WAS HOPING FOR. I WANT TO DO IT EVERY SIX MONTHS. >> YES. >> OKAY. BUT THANK YOU. ON THAT NOTE I'LL ASK OUR PROGRAM OFFICE STAFF, ANYONE WISH TO MAKE AN ADDITIONAL COMMENT? OKAY. ANYONE FROM THE AUDIENCE? WELL, THEN WE'LL THANK EVERYONE FOR THEIR PARTICIPATION, AND WE'LL CONTINUE WITH -- [APPLAUSE] >> -- WITH OUR SCIENTIFIC MEETING IN TWO MINUTES.