>> GOOD MORNING. WELCOME BACK TO DAY 2. WE HAVE FEWER TOPICS ON AGENDA TODAY BUT I THINK WE CAN ANTICIPATE MORE DISCUSSION AND PERHAPS MORE INCOMPLETED TASKS AT THE END OF THE DAY. TO GET US STARTED, SINCE WE DO HAVE PEOPLE PARTICIPATING BY PHONE TODAY, SOME OF OUR PANELISTS WILL BE ON WEBEX, I WOULD LIKE--WE WILL GO AROUND THE ROOM AND INTRODUCE OURSELVES AND I WOULD ASK THAT FOR THE REST OF THE DAY, PARTICULARLY GIVEN THE WEBEX AND THE BROADCAST, THAT PEOPLE MAKE IT A POINT NOT ONLY SPEAK LOUD BUT SPEAK INTO THEIR MICROPHONES. SO WE OFTEN--I'M AS GUILTY AS OTHERS, TURN THEM ON AND THEN TURN TO SPEAK TO OTHER PEOPLE IN THE ROOM BUT PEOPLE CAN'T HEAR THEM OVER THE BROADCAST EVENT SETTING. SO JONATHAN, WOULD YOU START? >> JONATHAN GREEN FROM WASHINGTON UNIVERSITY IN ST. LOUIS. >> DIANEA CNINGAS, PATIENT RESEARCH ADVOCATE IN LOS ANGELES. >> HOLLY FERNANDEZ, LYNCH UNIVERSITY IN PENNSYLVANIA. >> LESLIE WOLF GEORGE STATE UNIVERSITY COLLEGE OF LAW. >> MA RISK--MARISSA, OFFICE FOR CIVIL RIGHTS. >> JOANNE LESS, FDA. >> JOHN PANE NIH OFFICE OF POLICY. >> NIH DEPARTMENT OF COMMERCE. >> KAREN JANES, V. A. >> SARAH V. A. CORPORATION. >> NANCY WAKE FIELD,. >> STEPHEN ROSENFELD, OHRP. >> JULIA, WITH OHRP. >> AND WE'LL ALSO BE JOINED BY DR. REID PIRATES, FROM THE UNIVERSITY OF PENNSYLVANIA WHEN IS NOT HERE YET. SO I THINK WE WILL JUMP INTO THE AGENDA AND THE FIRST ITEM IS SOME BACKGROUND ON KEY INFORMATION FROM DR. MENIKOFF. >> THANK YOU STEPHEN. I WANT TO THANK EVERYBODY FOR YESTERDAY. THE COMMITTEE ACCOMPLISHED A GREAT DEAL AND OHRP IS VERY APPRECIATEDDATIVE OF ALL YOUR WORK. SO WHAT I WANT TO DO NOW IS BASICALLY FRAME THE KEY INFORMATION SECTION OF THE ADVISED REGULATIONS, MEN OF US VIEW THIS PROVISION AS 1 OF THE MOST IMPORTANT IN NEUROVISIONS TO REGULATIONS AND WE THINK IT HAS A HUGE POTENTIAL FOR IMPROVING THE SYSTEM. AND WE WANT PEOPLE TO HAVE A SENSE OF PERHAPS HOW YOU MIGHT THINK ABOUT IT IN TERMS OF THE GOALS THAT WERE BEHIND PUTTING THIS IN. THE OVERALL PURPOSE OF THE CHANGES TO THE CONSENT PROVISIONS AT HEART TO BE TRUER TO THE ETHICAL UNDERPINNING, ETHICAL FOUNDATIONS OF THE REGULATIONS AND IF YOU GO BACK TO THE NUREMBERG CODE, WHAT I THOUGHT WAS A WONDER QUOTE THAT I THOUGHT WAS WHERE THEY WERE GIVING THE PERSON AN INFORMED DECISION ABOUT WHETHER THEY DO OR DO NOT WANT TO PARTICIPATE IN A TRIAL. AND CERTAINLY FOR DECADES, PEOPLE HAVE DEBATED HOW GOOD A JOB THE CURRENT SYSTEM IS DOING AND THERE ARE CERTAINLY MANY, MANY PAPERS OUT THERE HIGHLIGHTING THE VARIOUS WAYS IN WHICH THE SYSTEM ISN'T DOING AS GOOD A JOB AS IT COULD BE DOING. AND WE COULD CERTAINLY GO THROUGH A VARIETY OF THE COMPLAINTS AND IN PARTICULAR WE'RE TALKING ABOUT HERE, WE'RE RECOGNIZING THAT CONSENT AS A PROCESS, BUT THE CONSENT FORM FORM IS A KEY ELEMENT OF IT AND A REGULATORY MATTER AND THAT'S THE PART OF THE PROCESS THAT IT'S JUST EASY TO REGULATE. THE FACT THAT CERTAIN INFORMATION IS IN A CONSENT FORNL, AT LEAST PROVIDES SOME LIKELIHOOD THAT THE PERSON ACTUALLY DEMONSTRATE THAT THEY ACTUALLY GOT THAT THEY RECEIVE THE CONSENT FORM AND HOPEFULLY, THEY AT LEAST READ PART OF IT BUT THE COMPLAINTS ARE THAT CONSENT FORMS HAVE BEEN TOO LONG, LARGE PORTION OF THE CONSENT FORM WERE BOILER PLATE IN CERTAIN PORTION OF THE CONSENT FORM, THERE'S JUST VAGUE LANGUAGE YOU COULD HAVE ACTUALLY WRITTEN THE CONSENT FORM FOR ANY TRIAL WITHOUT KNOWING ACTUALLY WHAT IS GOING TO HAPPEN THIS IN TRIAL AND THE RESULT OF ALL THESE THING SYSTEM THAT A PERSON MAY NOT BE GETTING THE INFORMATION THEY MOST NEED AND MAY NOT BE GETTING THAT IN A PARTICULARLY USEABLE FORMAT. SO THIS GETS TO A CONCLUSION THAT PERHAPS AT THE HEART OF ALL THESE COMPLAINTS IS THAT CONSENT FORMS ACTUALLY AREN'T ALL THAT WELL DESIGNED TO ACTUALLY AID A PERSON IN REACHING WHAT THE NUREMBERG CODE WAS TALKING ABOUT WHICH WAS HELPING THEM MAKE AN ENLIGHTENED DECISION ABOUT BEING IN A TRIAL AND MAYBE THIS IS THE BIGGEST DEFECT AND MAYBE THIS IS SOMETHING THAT IT IS POSSIBLE TO REMEDY AND AGAIN THAT WAS WHAT THE REGULATIONS WERE SORT OF MOVING TOWARD IN TERMS OF A VARIETY OF CHANGES IN TERMS OF INFORMED CONSENT AND IN PARTICULAR, IN TERMS OF THIS SORT OF KEY INFORMATION SECTION AT THE FRONT OF THE CONSENT FORM THAT WHEN SOMEBODY'S GIVEN A 30 PAIM CONSENT FORM WHERE THE REALLY IMPORTANT STUFF IS SORT OF SCATTERED THROUGHOUT THE FORUM, PARTICULARLY IN THE MODERN WORLD WHERE ATTENTION SPANS ARE NOT AS HIGH AS PERHAPS THEY--AS LONG AS THEY USED TO BE--IT'S NOT AS HELPFUL AS STARTING OUT AT THE FRONT OF THE FORUM WHERE YOU KIND OF EXTRACT ALL THIS IMPORTANT INFORMATION AND PUT IT TOGETHER AND I'LL GO THROUGH A LITTLE MORE ON THAT. ONE EXAMPLE, I THINK IS HELPFUL IS, YOU KNOW MOST OF US I'M SURE IF YOU WATCH TV, YOU HAVE ENCOUNTERED DRUG ADVERTISING AND IN MANY WAYS IT'S NOT ALL THAT SIMILAR FROM THE WAY CONSENT FORMS ARE KIND OF PUT TOGETHER. YOU KNOW THEY TELL YOU ABOUT THE BENEFITS, OR YOU HAVE THIS DISEASE AND HERE'S A WONDERFUL DRUG THAT WILL DO WONDERFUL THING FOR YOUR DISEASE WITH PEOPLE DANCING AROUND AND FLOWERS AND ALL THESE OTHER THINGS AND THEN THEY WILL GO ON AND GIVE YOU THE BENEFITS AND THEN THEY WILL GO ON THE RISK SITE AD NAUSEUM THIS LIST OF RISKS WHICH GIVEN THAT IT'S SORT OF SQUISHED INTO A 1 MINUTE COMMERCIAL IT'S LIKE HOW COULD SOMEBODY ABSORB IT, WE'RE YOU'VE GIVEN THE BENEFITS AND THE RISKS, YOU'RE IN A GOOD POSITION TO FIGURE THESE OUT TENTATIVELY WHETHER YOU WANT THIS AND I SUSPECT MOST OF US NOW THAT THAT'S NOT AN IDEAL WAY DO IT AND AT LEAST THOSE THINGS ARE PLATE ANTLY COMMERCIALS AND THEY ARE ADVERTISING. WHEREAS OUR CONSENT FORM IN RESEARCH IS NOT FOR ADVERTISING, IT IS DESIGNED TO BE AN UNBIASED DOCUMENT THAT WILL HELP SOMEBODY MAKERS AND A DECISION AND THAT'S WHAT THE KEY INFORMATION PART WAS ABOUT. IT'S GETTING IT DESIGNED TO BE AID. SO LET ME TELL YOU A FEW THINGS IN TERMS OF WHAT IT IS DESIGNED TO BE DOING, PARTLY, IT'S GOING TO TAKE INFORMATION AND OTHER PARTS OF THE CONSENT FORM, THE MOST IMPORTANT PIECE OF INFORMATION, SURE PART OF YOUR DISCUSSION WILL BE WHAT IS THE MOST IMPORTANT TYPE OF INFORMATION, BUT I SUSPECT IN MANY CASES, PEOPLE ACTUALLY COULD AGROW ON--AGREE ON THAT AND TAKE IT FROM THE LONG PART OF THE CONCEPT FORM AND PUT IT RIGHT UP FRONT. SO IT'S UP FRONT AND A PERSON DOESN'T HAVE TO HUNT THROUGH THE FORM TO FIGURE OUT WHAT IS MOST IMPORTANT TO THEM. ON SOME PIECES, IT IS GOING TO--THIS IS PART OF THE KEY INFORMATION TOGETHER WITH THE OTHER CHANGES, GOING TO ADD MORE DETAIL COMPARED TO WHAT CURRENT CONSENT FORMS ARE, SO A COMMON EXAMPLE OF BENEFIT SECTIONS ARE OFTEN JUST VERY, VERY VAGUE, SO YOU MAY NOT BENEFIT FROM BEING IN THIS TRIAL, THAT'S NOT HIEWNLLY HELPFUL TO SOMEBODY, PARTICULARLY WHEN YOU'RE IN CERTAIN TYPES OF TRIALS WHERE IN FACT WE KNOW A LOT OF INFORMATION ABOUT YOUR LIKELIHOOD OF BENEFITING, LIKE IT'S VERY, VERY LOW. WHERE IT WOULD TELL SOMEBODY YOU MAY OR MAY NOT BENEFIT, YOU'RE THINKING WELL MAYBE IT'S LIKE A 50/50 THING AND THEY THINK IT MIGHT CURE THEIR CANCER WHEN THE CHANCE OF THAT IS CLOSE TO 0 AND YOU COULD HAVE TOLD THEM IT'S CLOSE TO 0 OR YOU MIGHT NOT BE TELLING THEM WHAT THE TYPE OF BENEFIT IS, WHICH IS COULD BE THE BENEFIT THAT THE RESEARCHERS THINK IS MOST LIKELY IS IT'S GOING TO REDUCE YOUR SYMPTOMS, REDUCE YOUR PAIN AS OPPOSE TO CURING YOUR CANCER SO AGAIN, YOU ARE DESCRIBING THAT IN APPROPRIATE DETAIL. SO THERE'S A SUM OF THINGS IT'S INTENDED TO DO BUT PERHAPS MOST IMPORTANTLY, IT'S NOT JUST EXTRACTING THOSE PIECES OF INFORMATION AND PUTTING THEM IN THE FRONT BUT PUTTING THEM TOGETHER IN A WAY THAT ACTUALLY HELPS THE PERSON UNDERSTAND HOW TO THINK ABOUT WHAT'S HAPPENING AND HOW TO MAKE A DECISION. AND CONSENT FORMS BY AND LARGE DO NOT DO THAT. IT'S AGAIN MORE SIMILAR TO THE DRUG COMMERCIALS WHERE, HERE ARE THE BENEFITS, HERE ARE THE RISKS AND IN CONSENT FORMS THEY'LL HAVE A LOT OF OTHER SECTIONS INCLUDING ALTERNATIVES BUT IT DOESN'T PUT IT ALTOGETHER AND SAY, YOU KNOW, IT'S AS IF, YOU KNOW PEOPLE CAN INTUITIVELY FIGURE ALL THIS OUT AND THE QUESTION IS WHY DO WE FORCE PEOPLE TO DO THAT AS OPPOSE TO PUTTING ALL THE PIECES TOGETHER AND EXPLAINING THEM. LOOK, IF THIS IS YOUR GOAL, THESE ARE YOUR VALUES, HERE'S WHAT YOU MIGHT WANT TO DO IN TERMS OF THIS, AND 1 OF THE THINGS YOU WILL ALMOST NEVER FIND IN THE CONSENT FORMS IS AN EXPLANATION OF--AND THIS IS IN MANY WAYS AGAIN RELATED TO DRUG COMMERCIALS--THEY'RE NOT GOING TO SAY IN HERE, HERE ARE THE REASONS WHY YOU MIGHT NOT WANT TO BE IN THIS TRIAL. WHERE IF IT IS INNATE IN DECISION MAKING IT SHOULD BE COVERING BOTH OF THESE OPTIONS, HERE'S WHY YOU MIGHT NOT WANT TO BE IN THE TRIAL, OR BE IN THE TRIAL. SO THIS LAST PART OF IT, PUTTING ALL THE PIECES TOGETHER AND TRYING TO EXPLAIN IT IN LANGUAGE, LIKE, THAT ACTUALLY SAYS, HERE'S HOW YOU SHOULD BE THINKING ABOUT ALL INFORMATION AND PUT IT TOGETHER IN TERMS OF HOW YOU MAKE DECISIONS. THIS IS NOT AN EASY TASK TO DO. AND WE CERTAINLY LOOK FORWARD TO GETTING THE INPUT OF MANY, MANY PEOPLE INCLUDING PEOPLE WHO HAVE BEEN KIND ENOUGH TO PRESENT TODAY. AND WE CERTAINLY THINK IT IS DOABLE. I WANT TO NARROW IT DOWN TO 1 EXTENT BECAUSE THE ACTUAL ASK OF THE SACHRP COMMITTEES KNOW, RELATED TO CLINICAL TRIALS BECAUSE IN MANY RESPECTS THAT IS THE PART OF THE RESEARCH UNIVERSE THAT THESE CHANGES ARE MOST LIKELY TO HAVE THE MOST SIGNIFICANT IMPACT. PERHAPS FOR MANY PEOPLE THERE'S MOT MOST AT STAKE, CERTAINLY AT SOME CLINICAL TRIALS. AND THE NICE THING, AT LEAST THE THING WE HAD IN MIND IN TERMS OF WHO WE'RE REACHING OUT TO NOW IS THAT FOR MANY CLINICAL TRIALS, THE TYPE OF DECISION THAT THE PERSPECTIVE SUBJECT IS BEING ASKED TO MAKE IS IN MANY WAYS SIMILAR TO THE SORTS OF DECISIONS PEOPLE MAKE IN TERMS OF CLINICAL DECISIONS OUTSIDE OF RESEARCH. IT'S INTERESTING BECAUSE HISTORICALLY MANY PEOPLE WOULD GO AWAY FROM THAT TAKE AND SAY OF COURSE, WELL IT'S NOT ABOUT A CLINICAL DECISION BECAUSE THESE ARE UNPROVEN TREATMENTS, BUT WHETHER THEY'RE UNPROVEN OR NOT FOR SOMEBODY WHO AS A PARTICULAR MEDICAL PROBLEM AND THEY'RE ASKED TO PARTICIPATE IN THE TRIAL AND YOU KNOW TREATMENTS THEY'RE BEING GIVEN ARE WHAT THEY'RE GOING TO GET IN TERMS OF TREATING THEIR MEDICAL PROBLEM. IT IS A CLINICAL DECISION. SO THE THINKING IS, LET'S LOOK TO WHAT PEOPLE HAVE BEEN DOING IN TERMS OF IMPROVING CLINICAL DECISION MAKING. THIS IS NOT A NEW IDEA, YOU KNOW VERY SMART PEOPLE HAVE BEEN WORKING ON THIS FOR DECADES AND LET'S KIND OF TAKE THAT TO THE EXTENT WE CAN LEARN FROM IT AND SEE IF THERE'S A WAY OF IMPROVING RESEARCH CONSENT FORMS AND 1 EXAMPLE, FOR EXAMPLE THAT COMES TO MIND IN COMPARING WHAT WE DO TO THE CLINICAL RESEARCH CONTEXT, AND PEOPLE COULD THINK ABOUT THEIR OWN CLINICAL DECISION MAKING, HOW OFTEN WHEN A PHYSICIAN, YOU KNOW IS ABOUT TO TREAT YOUR PARTICULAR CONDITION AND THEY GIVE YOU--HERE'S THE MEDICATION WE WANT TO PUT YOU ON, THEY REAL LE HAND YOU THE FDA APPROVED LABELING AND SAY, YOU KNOW HERE'S 10 PAGES OF ALL THE RISKS AND MAYBE YOU WANT TO REALLY WANT TO LETTA ALONE DISCUSS IT WITH YOU FOR 5-10 MINUTES WHEREAS IN RESEARCH CONSENT FORMS, THE LARGEST PART IS PARTICULARLY FOR CHEMO THERAPY AND OTHER TYPES OF DRUGS THAT HAVE LOTS OF SIDE EFFECTS, PAGES AND PAGES OF THESE COMPLICATED GRIDS THAT ARE CATEGORIZING THE RISKS ACCORDING TO FREQUENCY AND THEIR NATURE. I WAS ON AN IRB FOR A NUMBER OF YEARS AND 1 OF THE IRB MEMBERS WOULD METICULOUSLY ALMOST EVERY TIME WE HAD A CONSENT FORM FIND A RISK OR 2 THAT WAS IN THE LABELING INFORMATION THAT DIDN'T MAKE IT TO THE CONSENT FORM. OF COURSE ALL THE STUDIES BACK THERE ARE GOING TO COIN, OMAN AND OTHER PSYCHOLOGY OF DECISION MAKING, AND THESE ARE NOT DESIGNED TO PROCESS MASSIVE DECISIONS OF STUFF, IT'S MORE TO PROCESS FEW KEY PIECES OF INFORMATION SO AGAIN, LET'S ELECTRIC AT HA HAPPENS IN THE CLINICAL SETTING AND PUT THAT TOGETHER AND THAT'S WHERE THE KEY INFORMATION SECTION IS ABOUT THIS AND WHAT ARE THE 3 OR 4 PIECES OF INFORMATION THAT MOST MATTER TO SOMEBODY IN TERMS OF MAKING THESE DECISIONS. IT'S CERTAINLY MORE COMPLICATED DECISION THAN MANY CLINICAL DECISIONS BECAUSE YOU'RE DEALING WITH 1 OPTION OFTEN BEING AGREEING TO BE IN A RANDOMIZED TREATMENT OPTION AND THAT'S SOMEWHAT HARD TO EXPLAIN AND WHAT DOES IT MEAN FOR SOMEBODY TO BE OKAY WITH THAT AS OPPOSE TO THEN YOU HAVE TO LAY OUT THE OTHER OPTIONS, FOR EITHER OF THE ARMS INCLUDING 1 ARM THAT WILL BE INNOVATIVE AND MAYBE OFF-LABEL, THOSE AS OTHER OPTIONS, AGAIN GETTING THE RAPPED ORDER OF MICRONSIZATION AND THEN SORT OF DESCRIBING SOME OF THE TREATMENTS ARE PROBABLY MORE UNCERTAIN THAN A LOT OF CLINICAL TREATMENTS ARE AND EXPLAIN TO A PERSON, WELL, WE'RE NOT SURE WHETHER THIS WILL WORK BUT HERE ARE THE REASONS SOME PEOPLE THINK IT MIGHT BE BETTER THAN THE ALTERNATIVE TREATMENT YOU COULD GET DUE TO EITHER PERHAPS HAVING GREATER EFFICACY OF CURING YOUR VERY SERIOUS PROBLEM OR NOT HAVING A PARTICULAR SERIOUS SIDE EFFECT THAT IS A REASON WHY MANY PEOPLE DON'T WANT THE CURRENT TREATMENT. SO THAT'S SORT OF I THINK WHAT THE GOAL IS FOR THE CHANGES TO THE REGULATIONS AND AGAIN WE VERY MUCH LOOK FORWARD TO HEARING HOW PEOPLE ARE THINKING ABOUT THIS AND WHAT THEY WOULD BE PROPOSING AS WAYS OF ACTUALLY DOING THIS AND IN PARTICULAR THINK LOOKING AT EXAMPLES IS A VERY GOOD WAY FOR PEOPLE TO START WRAPPING THEIR HEADS AROUND WHAT THIS SORT OF SECTION WILL LOOK AT. THAT'S ALL I WANT TO SAY. I DON'T KNOW IF ANYBODY HAS ANY QUESTIONS ABOUT THAT. WE CAN TURN IT TO THE PRESENTATION. >> THANK YOU VERY MUCH. I THINK THAT'S ACTUALLY ENORMOUSLY HELPFUL. THAT PERSPECTIVE AND I THINK YOU KNOW WE JUST FROM THE DISCUSSIONS AT THE SUBCOMMITTEE, THERE'S ALWAYS ATTENTION WITH GUIDANCE OR GIVING DIRECTION BETWEEN SORT OF COMPLIANCE BASED SORT OF COMPLIANCE LEADING TEMPLATES AND THE KIND OF THOUGHTFUL PROTOCOLS BY PROTOCOL CONSIDERATIONS THAT I THINK REALLY COMPLETELY FULFILL IN SUCH A MANDATE WOULD REQUIRE. I ALSO THINK AS YOU SUGGESTED THAT WE REALLY DO NEED TO LOOK AT DATA. AND I THINK THAT'S REALLY THE BASIS OF OUR FIRST PANEL WHICH I WOULD LIKE TO INTRODUCE NOW. SO THE BIOS FOR THE PEOPLE ON THE PANEL ARE IN TAB M IN YOUR NOTEBOOKS. WE ARE HAVE DR. BRIAN ALPER, VICE PRESIDENT INNOVATIONS AND EVIDENCE-BASED MEDICINE AND EVIDENCE-BASED MEDICINE FROM EBSCO HEALTH AND HE WILL START BUT HE WILL BE JOINED BY WEBEX BY DR. STEVEN WOLOSHIN, AND DR. LISA SCHWARTZ WHO ARE THE CENTER FOR MEDICINE AND THE MEDIA AT DARTMOUTH INSTITUTE FOR HEALTHY POLICY AND CLINICAL PRACTICE. I WOULD INVITE TO EBSCO--SORRY ABOUT THAT--DR. ALPER TO START AND THEN WE WILL TURN TO THE REMOTE PRESENTERS. >> EBSCO HAS A LOT OF DOCTORS, NOW YOU BI THINK I WAS THE FIRST 1 NOW. I WILL GIVE YOU A BIT OF MY BACKGROUND ALSO DISCLOSING ANY COMPETING INTERESTS AND EXPLAINING IN A LARGE PART WHY I'M HERE SPEAKING NOW. SO IN THE EARLY 90S IN MEDICAL SCHOOL I REALIZED I CANNOT MEMORY MEMORIZE MEDICINE, BUT THAT WAS THE WAY MEDICINE WAS BEING TAUGHT. I NEEDED TO FIGURE OUT HOW COULD I FIND THE KEY INFORMATION WHEN I NEED IT TO TAKE CARE OF A PATIENT. SO I STARTED ORGANIZING INFORMATION SO I COULD FIND IT WHEN I NEEDED IT. THAT INFORMATION BECAME SO USEFUL FOR OTHER PHYSICIANS, HELPING MAKE DIAGNOSIS, MAKE TREATMENT CHANGES IN DAILY PRACTICE THAT IN 1995 I TURNED IT INTO A DATABASE, CALLED IT DYNAMIC MEDICAL INFORMATION SYSTEM, IT SHOULD ALSO BE CHANGING OR DYNAMED WAS THE SHORT NAME. IN 2005 I SOLD DYNA MED TO EBSCO, TO HELP WITH SCALING AND TODAY THERE ARE HUNDREDS OF DOCTORS AND EPIDEMIOLOGISTS AND OTHERS WORKING ON IT TO KEEP IT CURRENT, ACCURATE, BEST INFORMATION FOR THE POINT OF CARE AND IT'S USED BY MILLIONS AROUND THE WORLD. SO IN DOING THIS, WE HAVE VERY SYSTEMATIC DETAILED METHODS TO FIND THE EVIDENCE, SYSTEMATICALLY SELECT THE EVIDENCE, NOT JUST LOOKING AT INDIVIDUAL BIAS OF AUTHORS AND EDITORS, CRITICALLY APPRAISE THE EVIDENCE IN GREAT DETAIL. MUCH OF WHAT IS PUBLISHED IS MISLEADING IF TAKEN ASTERISKS FACE VALUE. AND THEN SENTHICIZING THAT AND PUTTING IT TOGETHER, WHAT DOES THE EVIDENCE AND GUIDANCE TELL US AND HOW WELL DO WE KNOW WHAT WE THINK WE KNOW. AND AGAIN PROVIDING THIS IN THE CLINICAL REALM FOR POINT OF CARE USE. SO, THAT HAS LED TO MANY OTHER DEVELOPMENTS AS WE DEVELOPED THE ABILITY TO KEEP UP WITH EVIDENCE, EVIDENCE-BASED MEDICINE IN THE PAST 20 YEARS HAS SHIFTED FROM AN ACADEMIC CONCEPT. THIS IS SOMETHING WE SHOULD DO, BUT WE DO NOT REALLY KNOW HOW TO A DAY-TO-DAY EXPECTATION. IT IS NOW REALISTIC TO FIND THE EVIDENCE GIEDING DECISIONS GUIDING DECISIONS DURING CLINICAL PRACTICE. SO OOM INVOLVED IN MANY DIFFERENT COMMITTEES AND WORK GROUPS HELPING DEVELOP, HOW DO WE ASSESS THE EVIDENCE? HOW DO WE PUT IT INTO SYSTEMATIC REVIEWS AND GUIDELINES AND ULTIMATELY CLINICAL DECISION SUPPORT FOR AUTOMATIC CONNECTIONS BETWEEN THAT AND PATIENT DATA FOR GUIDING DECISION MAKING. A COUPLE OF YEARS AGO, THE INTERNATIONAL SOCIETY FOR EVIDENCE-BASED HEALTHCARE MET WITH THE INTERNATIONAL SHARED DECISION MAKING GROUP. AND THAT WAS A GREAT CONNECTION BETWEEN THIS WORLD OF HOW DO WE GET THE INFORMATION RIGHT FOR WHAT WE KNOW AND THIS WORLD OF HOW DO WE INFORM PATIENTS WHEN MAKING DECISIONS AND INVOLVE THEM IN THE PROCESS. SO THAT HAS LED TO A JOINING OF EBSCO HEALTH WITH OUR EXPERIENCE IN SCALING AND SYSTEMATIC UNDERSTANDING OF THE EVIDENCE, AN OPTION GRID WHICH WAS A WELL RESEARCHED METHOD FOR SHARED DECISION MAKING IN THE ENCOUNTER AND HOW YOU CAN PROVIDE IN AN EASY WAY WHAT THE PATIENT NEEDS TO KNOW TO MAKE THAT DECISION AND BE PART OF THAT DECISION BUT THE CHALLENGE WITH OPTION GRID WAS THE SCALING. HOW DO YOU KEEP UP WITH ALL THE INFORMATION TO KNOW THAT YOU HAVE IT RIGHT AND KEEP IT CURRENT. SO WE ARE NOW WORKING TOGETHER TO PRODUCE EBSCO HEALTH OPTION GRID AND THIS IS FOR THE PATIENT CARE ENVIRONMENT. HIGH QUALITY PATIENT DECISION AIDS THAT COVER WHAT ARE THE OPTIONS MOST RELEVANT FOR THAT DECISION. SO IN THE CONTEXT OF CLINICAL TRIAL PARTICIPATION, THAT WOULD BE WHAT ARE THE ALTERNATIVES MOST RELEVANT WHEN CONSIDERING THAT TRIAL. THE OPTION GRID WILL COVER WHAT QUESTIONS ARE MOST IMPORTANT TO PATIENTS FACING THE DESIGDZ AND WE ACTUALLY SYSTEMATICALLY LOOK FOR EVIDENCE OF WHAT IS IMPORTANT TO PATIENTS WHEN FACING THAT CLINICAL DECISION AND THEN DO PATIENT SURVEYS IF THE EVIDENCE IS NOT ALREADY THERE. AND THEN WHEN WE PUT THE INFORMATION TOGETHER, WE WILL DO PATIENT SURVEYS TO MAKE SURE WE'VE COVERED WHAT THE PATIENTS FEEL THEY NEED FOR FACING THE DECISION. FOR EACH OF THOSE QUESTIONS, WE HAVE TO FIND AND UNDERSTAND THE COMPLEX EVIDENCE TO DETERMINE THE ACCURATE ANSWERS AND THERE'S MANY STEPS INVOLVED IN THAT PROCESS. BUT THEN JUST HAVING THE ANSWER SYSTEM NOT ENOUGH. WE NEED TO SUMMARIZE THE ANSWERS IN FORMATS THAT ARE EASY TO UNDERSTAND IN THE CONTEXT OF DECISION MAKING. SO EASY TO UNDERSTAND, SIXTH GRADE READING LEVEL OR LOWER IN THE CONTEXT OF DECISION MAKING. WHEN YOU SEE THE INFORMATION SIDE BY SIDE FOR DIFFERENT OPTIONS YOU HAVE TO HAVE SIMILAR FRAMES OF REFERENCE TO MAKE IT EASY TO UNDERSTAND FOR COMPARISONS. AND THEN OF COURSE, HOW DO YOU KEEP UP WITH THIS AS EVIDENCE CHANGES? SO I HAVE MADE MY PERSONAL GOAL, PERSON MISSION TO PROVIDE THE USEFUL SUPPORT FOR DECISION MAKING AND IN THE CONTEXT OF FOCUSING ON KEY INFORMATION FOR SHARED DECISION MAKING, I TEND TO SPIN ACRONYMS A LOT AND IN THIS CASE, THIS SHOULD LED TO WELL-INFORMED SHARE DECISION MAKING. OR WE'RE ALL SEEKING WISDOM. SO WHAT IS KEY INFORMATION? WELL, YOU HAVE THIS IN YOUR MATERIALS ALREADY, THE INFORMED CONSENT MUST BEGENERATED WITH THIS CONCISE AND FOCUSED PRESENTATION. WHAT IS MOST LIKELY TO ASSIST IN MAKING THE DECISION. IT MUST BE ORGANIZED PRESENTED IN A WAY THAT FACILITATES COMPREHENS AND THE PREAMBLE HAS 5 ELEMENTS THAT NEED TO BE COVERED. THE FACT THIS IS A DECISION AND IT'S VOLUNTARY DECISION, THE REASON FOR THE RESEARCH AND WHAT YOU WOULD EXPECT TO BE INVOLVED, THE RISKS, THE BENEFITS AND WHAT ARE THE ALTERNATIVES. SO YOU ALREADY HAVE A LOT OF THE DEFINITION OF WHAT IS KEY INFORMATION BUT HOW CAN PROVIDING THAT BE DONE ACCURATELY, EFFECTIVELY, AND EFFICIENTLY. HOW DO WE MAKE THIS WORK FOR REAL. SO WHAT DOES THE PERSPECTIVE SUBJECT NEED TO KNOW. WHAT IS RELEVANT. YOU DON'T WANT 30 PAGES OF KEY INFORMATION. YOU HAVE TO FOCUS ON WHAT IS MOST RELEVANT FOR MAKING THAT DECISION. WILL THE PERSPECTIVE SUBJECT BE OF INFORMED UPON READING IT. TECHNICALLY HAVING THE INFORMATION, MAY COUNT IN THE LEGAL ENVIRONMENT BUT IF YOU'RE ACTUALLY USING IT FOR DECISION MAKING, IT HAS TO BE EASILY UNDERSTOOD OR IT'S NOT REALLY WELL INFORMED. IS THE KEY INFORMATION CORRECT. HOW DO WE GET THE INFORMATION TO BE ACCURATE WITH ALL OF THE COMPLEXITY THAT'S INVOLVED. AND HOW CAN WE PRODUCE THE KEY INFORMATION WITH LIMITED RESOURCES. ANYONE FEEL THAT THEY DON'T HAVE LIMITED RESOURCES? SO HOW DO WE ADD KEY INFORMATION AND KEEP IT RELEVANT, EASILY UNDERSTOOD, ACCURATE AND DO IT WITH LIMITED EFFORT? THAT'S HOW WE MAKE IT REAL. SO WHAT MIGHT REAL KEY INFORMATION LOOK LIKE? A SAMPLE CLINICAL TRIAL WAS SHARED WITH ME A WEEK OR SO AGO AND THE REFERENCES THERE, AND THIS IS A CLINICAL TRIAL FOR 2 DIFFERENT TREATMENT APPROACHES FOR EXTENSIVE METAAT THAT STATIC PROSTATE CANCER. THE INFORMED CONSENT DOCUMENT WAS 17 PAGES AND WRITTEN AT A NINTH GRADE READING LEVEL. WHAT I DID FSZ I USED THE PROCESS THAT WE USE FOR OPTION GRID DEVELOPMENT AND TRIED TO CREATE SOMETHING LIKE IT MEETING ALL OF THE CRITERIA ASKED FOR IN THE PREAMBLE, USING ALL OF THE INFORMATION IN THE 17 PAGE INFORMED CONSENT DOCUMENT AND DOING ADDITIONAL SEARCHES FOR THE BEST EVIDENCE FOR BENEFITS AND RISKS AND PUT THAT ALTOGETHER IN SOMETHING THAT MADE IT INTO 3 PAGES. YOU CAN FIND IT UNDER TAB M IN YOUR BOOK. THE FIRST PAGE IS A--JUST KIND OF A REAMBLE DESCRIPTION OF THE TRIAL AND THE NEXT 2 PAGES ARE COMPARISON TABLES. I WILL DISCLOSE THIS IS AN UNTESTED EXAMPLE. THERE HAVE BEEN NO PATIENT TESTING IN THE PAST WEEK TO VALIDATE THIS COVERS THE KEY QUESTIONS AND IS EASY TO UNDERSTAND IN THE CONTEXT OF DECISION MAKING FOR CLINICAL TRIAL PARTICIPATION AND IF DOING THIS FOR REAL, I WOULD THEN WANT TO INCLUDE REPRESENT REPRESENTATIVE--PATIENTS REPRESENTATIVE PERSPECTIVE TRIAL PARTICIPANTS AND HAVE THEM REVIEW IT AND GIVE THE FEEDBACK THAT IT MEETS THEIR NEEDS. SO WHAT I WOULD LIKE TO DO IS BREAK IT DOWN AND GO THROUGH THIS EXAMPLE AND TALK ABOUT HOW DO WE MAKE IT REAL AND I CAN ALSO SHOW YOU HOW WE DO THIS FOR THE CLINICAL DESIGDZ--DECISION MAKING ENVIRONMENT. SO WHAT MAY BE HELPFUL IF I BREAK HERE AND FIRST SHOW YOU HOW WE'RE DOING IT FOR CLINICAL DECISION MAKING AND THEN COME BACK TO THIS AND DISCUSS IT FOR THE EXAMPLE, FOR CLINICAL TRIAL PARTICIPATION. SO OPTION GRID IS THE SHARED DECISION MAKING RESOURCE THAT WE'VE BUILT. WE COVER COMMON CONDITIONS THAT ARE IMPORTANT AND HAVE PREFERENCE SENSITIVE DECISIONS. RIGHT? THIS WHERE THE PATIENT NEEDS TO PARTICIPATE TO ROLELY DETERMINE THE TREATMENT THAT IS RIGHT FOR THEM THIS EXAMPLE IS FOR ATRIOLE FIB ROUGH ATOMALATION, CARDIAC CONDITION, HEART CONDITION WHERE PART OF THE HEART IS NOT BEATING REGULARLY AND 1 PROBLEM THAT CAN OCCUR IS THE BLOOD CLOT AND THAT BLOOD CLOT CAN BREAK OFF AND CAUSE A STROKE. SO THIS WILL BE TREATMENT OPTIONS TO LOWER SOMEONE'S STROKE RISK WHEN THEY HAVE ATRIOLE FIB ROUGH ATOMALATION, FOR THIS PARTICULAR DECISION TO BE MADE, GETTING THE APPROPRIATE INFORMATION TO THE PATIENT INCLUDES UNDERSTANDING PARAMETERS OF THE PATIENT WHAT IS THEIR AGE, WHAT IS THEIR GENDER, DO THEY HAVE OTHER CONDITIONS? AND IF WE CHANGE THESE PARAMETERS IT LEADS TO DIFFERENT RISKS OF MAJOR PLEADING AND RISKS OF STROKE DUE TO BLOOD CLOTS. SO IN THIS CASE, WE ASK FOR THAT INFORMATION UPFRONT SORE IF CONNECTED WITH THE ELECTRONIC MEDICAL RECORDS MAY BE ABLE TO PULL THAT DATA ALL RIGHT AND THERE ARE MANY OPTIONS TO CHOOSE FROM. SO THIS IS A TOOL WRA--WHERE THE PHYSICIAN MAY HELP DECIDE FOR THIS PATIENT, LET'S COMPARE WARFORIN, TO ASPIRIN TO MAYBE DOING NOTHING AND WE CAN TAYLOR THIS FOR DIFFERENT PATIENTS FOR THE DECISIONS THAT THEY ARE FACING. WHAT WE HAVE SEEN IS ALL THE WORK DEHIEBD THE SCENES TO DETERMINE THE WORK AND QUESTIONS FACINGLET PATIENT FOR THEIR DECISION. CAN YOU SEE THAT ON THE LEFT-HAND SIDE HERE. WHAT DOES THE TREATMENT INVOLVE? SIMILAR TO PREAMBLE NUMBER 2. MY RISK OF STROKE DUE TO BLOOD CLOTS, THAT IS THE BENEFIT QUESTION IN THIS CASE, WHAT IS THE BENEFIT OF TREATMENT IS LOWERING THE RISK OF STROKE DUE TO BLOOD CLOTS. MY RISK OF MAJOR PLOODING NEEDING TREATMENT, 1 OF THE RISKS AND OTHER RISKS AND SIDE EFFECTS SO THOSE ARE 2 OF YOUR QUESTIONS IN YOUR PREAMBLE. SOMETIMES THERE ARE UNIQUE QUESTIONS IN THE CIRCUMSTANCE, AND IN THIS CIRCUMSTANCE, CAN THE BLOOD THINNING OF THE EFFECT BE REVERSED? YOU KNOW IF YOU'RE IN AN EMERGENCY AND YOU NEED TO DO THAT, THAT BECOMES A UNIQUE QUESTION FOR THIS DECISION AND WHAT IS THE COST? AND WE HAVE FOR THESE 3 OPTIONS YOU WILL SEE THE ANSWERS ARE VERY EASY TO UNDERSTAND, SIXTH GRADE READING LEVEL OR LOWER AND WRITTEN ACROSS THE DIFFERENT OPTIONS. WE CAN ALSO PRODUCE THIS IN A PDF TO MAKE THIS EASIER FOR PRINTING IF PRINTING THIS AND GIVING IT TO THE PAIBT IS THE BEST FORM AND IN TODAY'S WORLD WE CAN ALSO PROVIDE THIS ON THE MOBILE DEVICE AND IT TAKES A DIFFERENT FORM. WE'RE READING A TABLE, ON YOUR CELL PHONE IS NOT THE BEST FORM. THIS SHOULD OPEN UP, AND I'M NOT SURE WHY IT'S NOT CLICKABLE RIGHT NOW BUT GIVE YOU 1 QUESTION AT A TIME TO FIT THAT FORM. SO THAT'S AN EXAMPLE OF HOW WE'RE MAKING IT REAL FOR CLINICAL DECISION MAKING. SO NOW TURNING IT BACK TO THE EXAMPLE FOR THIS CLINICAL TRIAL FOR EXTENSIVE METASTATIC PROSTATE CANCER, WHAT IS RELEVANT? AGAIN YOUR PREAMBLE BY REQUIREMENTS LAYS OUT MOST OF WHAT IS RELEVANT TO BE IN THE SKI INFORMATION. YOU MAY FIND AN OCCASIONAL EXAMPLE WHERE THERE'S A UNIQUE QUESTION LIKE FOR ATRIOLE FIB ROUGH ATOMALATION, CAN IT BE REVERSED IN AN EMERGENCY BUT FOR THE MOST PART YOU COVER WHAT IS RELEVANT IN YOUR PREAMBLE. BY EXPERIENCE FROM DEVELOPING THE PATIENT DECISION AIDS WHERE WE SEARCH FOR THE EVIDENCE, WE CONDUCT THE RESEARCH, WE CONFIRM IT, WE'VE REALLY DETERMINED THERE ARE 5 COMMON QUESTIONS FOR WHAT IS RELEVANT. WHAT DOES IT INVOLVE? RIGHT, WHAT DO I HAVE TO DO? HOW MUCH EXTRA TIME SCHEDULING? THINGS LOAMACYIC THAT. WHAT ARE THE BENEFITS? WHAT ARE THE RISKS? WHAT ARE THE SIDE EFFECTS? AND WE SEPARATE OW RISKS AND SIDE EFFECTS COMMONLY. YOU PUT IT TOGETHER AS A QUESTION. WHAT ARE THE RISKS AND DISCOMFORTS AND THEN WHAT ARE THE COSTS? SO YOU'VE COVERED THOSE IN YOUR PREAMBLE AS WELL. SO THE 1 XEPS--EXCEPTION FROM YOUR PREAMBLE, IS KNOWING THE ALTERNATIVE PROCEDURES OR SOURCES OF TREATMENTS IS ONLY INFORMATIVE FOR DECISION MAKING IF YOU ALSO KNOW THE KEY INFORMATION FOR THE ALTERNATIVES. IF YOU DO NOT--IF YOU KNOW AN ALTERNATIVE EXISTS BUT YOU DO NOT KNOW THE BENEFITS AND THE RISKS OF THE ALTERNATIVE, YOU CAN INTERPRET IT IN SOME OTHER WAY, HOWEVER IT IS FRAMED. SOA IS THE 1 PIECE THAT WAS ADDED IN THE EXAMPLE HERE TO FLESH OUT THE INFORMATION. SO WHAT IS EASILY UNDERSTOOD? YOU REQUIRE IT MUST BE ORGANIZED AND PRESENTED IN A WAY THAT FACILITATES COMP REMENTION AND FROM OUR SIDE, WE WRITE FROM A SIXTH GRADE READING LEVEL OR LOWER, IT'S LOOKS GREAT AT THE END BUT IT TAKE AS I LOT OF EFFORT TO MAKE IT. WE USE X-PERCENT PREFERENTIALLY OVER VAGUE PHRASES, IT IS COMMON, IT IS RARE, PEOPLE DON'T KNOW WHAT THOSE THINGS MEAN, OR RATES WITH DISMAL POINTS AND SOME PEOPLE HAVE TROUBLE WITH .7, PEOPLE HAVE THIS HAPPEN, IF WE HAVE TO WE WILL SAY OUT OF A THOUSAND PEOPLE FOR THE RARE RISKS AND RELATIVE RISKS AND FRACTIONS AND NUMBER NEEDED TO TREAT IN OTHER WAYS OF HANDLING THE NUMBERS, ALTHOUGH, THE RESEARCH IS STILL NOT FULLY COMPLETED, WHAT IS THE OPTIMAL METHOD TO CONVEY RISK INFORMATION TO PEOPLE. WE DO PRESENT QUANTIFIABLE RISKS WHEN REASONABLY AVAILABLE AND IT CAN BE REASONABLY AVAILABLE MORE OFTEN THAN PEOPLE REALIZE. WE PROVIDE THE INFORMATION SIDE BY SIDE TO BE EASILY UNDERSTOOD IN THE CONTEXT OF COMPARING OPTIONS. SIMPLY ANSWERING THE QUESTIONS, WHY WOULD I DO IT, WHY WOULD I NOT DO IT? DOES NOT SET UP THE SAME TYPE OF COMPARISON AS THE SIDE BY SIDE WAYING THE DIFFERENT OPTIONS. AND WE PAY ATTENTION TO HOW IT READS, WHAT IT SAYS IN THE CONTEXT OF COMPARING OPTIONS. AND WE'VE CAUGHT SEVERAL SITUATIONS WHERE THE BEST ANSWER TO WHAT DO YOU EXPECT TO HAPPEN WITH THIS TREATMENT OR WHAT IS THE BENEFIT, WHAT IS THE RISK AND THE BEST ANSWER TO ANOTHER TREATMENT WHEN PLACED SIDE BY SIDE DID NOT MAKE SENSE AND THE REASON IT DID NOT MAKE SENSE IS THE POPULATION STUDIED WERE DIFFERENT WHEN INTERPRETING THESE 2 TREATMENTINGS AND ALTHOUGH IT SEEMED BEST, IT REALLY WASN'T--YOU WEREN'T COMPARING FAIRLY OR EQUALLY. SO WE NEEDED TO MAKE ADJUSTMENTS FOR THAT. OKAY, SO WHAT IS ACCURATE? THERE ARE 4 MAJOR RISKS FOR PROVIDING INACCURATE INFORMATION. FIRST OF ALL THERE'S CONFLICT OF INTEREST, RIGHT? THAT DRUG THAT YOU ARE TALKING ABOUTA THAT PRESENTS THE BENEFITS AND THEN IT PRESENTS THE RISKS IN THE PRESENTATION ITSELF WHILE IT'S PRESENTING THE RISKS IT IS SHOWING YOU SOMETHING TO CATCH YOUR ATTENTION TO WATCH AND GIVEING YOU SOME NICE MUSIC SO MAYBE YOU DON'T PAY AS MUCH ATTENTION TO THE RISKS THAT ARE BEING PRESENTED. AND THEY MAY SAY THINGS WILL BE SLIGHT, WHAT DOES THAT MEAN? YOU KNOW? THERE'S A SLIGHT AMOUNT OF BOWEL CONTROL LOSS OR SOMETHING LIKE THAT. YOU KNOW HOW MANY PATIENTS WOULD THINK THAT'S THOUGH BIG DEAL. IN THE CONTEXT OF CLINICAL TRIAL PARTICIPATION, A CHALLENGING QUESTION MAY BE IS SOMEBODY INSENTED TO GET MORE PEOPLE TO SAY YES WHEN ENROLLING IN THE TRIAL AND DOES THAT COMPETE WITH GIVING BALANCED INFORMATION ABOUT THE TRIAL AND HOW THAT WOULD BE CONSIDERED IN THE DEVELOPMENT OF THIS CONTENT. SECOND, LACK OF AWARENESS OF THE CURRENT EVIDENCE. IF YOU ONLY KNOW 1 SOURCE OF INFORMATION AND YOU HAVE NOT DONE A SYSTEMATIC SEARCH ACROSS THE EVIDENCE, YOU MAY NOT GIVE COMPLETELY ACCURATE OR BEST CURRENT ANSWERS. THIRD, IF YOU ACCEPT WHAT'S PUB LISHED UNCRITICALLY, YOU MAY NOT GIVE ACCURATE CURRENT BEST INFORMATION AND MANY PHYSICIANS AND AUTHORS CONSISTENTLY OVERESTIMATE BENEFITS AND UNDERESTIMATE HARMS AND OVERESTIMATE HOW WELL WE KNOW WHAT WE KNOW. AND THEN FINALLY TRANSLATIONAL ERRORS, YOU CAN DO EVERYTHING ELSE RIGHT AND THEN IN THE EFFORT TO MAKE IT SIXTH GRADE READING LEVEL. OVERSIMPLIFY AND REINTRODUCE INACERACYS, SO THESE ARE THE 4 STAGES OR 4 AREAS YOU REALLY NEED TO PAY ATTENTION TO IF FOCUSING ON HOW DO YOU MAIC SURE THE INFORMATION IS ACCURATE AT THE END. AND THEN FINALLY WHAT IS LIMITED EFFORT? IN THE ARENA OF DEVELOPING CLINICAL PRACTICE GUIDELINES, GETTING THE KEY INFORMATION RIGHT IS A LARGE EFFORT. REALLY FINDING THE RIGHT EVIDENCE TO INFORM THE GUIDELINE PANEL AND DETERMINE WHAT THE MANY GUIDELINE DEVELOPERS DO THIS EVEN THOUGH EVERYONE ELSE IS ALREADY DOING IT AND IT'S A CONSIDERABLY WASTE OF LIMITED RESOURCES ACROSS THE WORLD. SO GUIDELINES HAVE BEEN DEVELOPED MORE EFFICIENTLY USING RESOURCES THAT HAVE ALREADY DONE THIS WORK AND THAT'S AN ARTICLE THAT PUBLISHED A YEAR OR 2 AGO, EXPLAINING A PROTOCOL WHERE THIS WAS DONE FOR A COUNTRY TO HELP THEM MAKE A HIGH QUALITY GUIDELINE IN LESS THAN 6 MONTHS, COMPREHENSIVE GUIDELINE FOR BREAST CANCER. MANY MEMBERS OF THE GUIDELINE DEVELOPMENT COMMUNITY AND AN ECOSYSTEM HOW IT ALL FITS TOGETHER ARE INTERESTED IN DEVELOPING SHAREABLE METHODS AND STANDARDS TO REDUCE THIS DUPLICATION OF EFFORT. IN THE AREA OF PATIENT DECISION AIDS FOR SHARED DECISION MAKING FOR THE CLINICAL CONTEXT, GETTING THE KEY INFORMATION RIGHT IS A LARGE EFFORT. MANY PATIENT DECISION AID DEVELOPERS REPRODUCE THE EFFORT AT AGAIN CONSIDERABLE WASTE OF LIMITED RESOURCES WHERE MANY GROUPS ARE FOCUSING ON THE SAME DECISIONS AND DOING THE WORK OVER AGAIN AND THE RESULT IN THIS CASE THERE'S NOT AS MUCH ACTIVITY WORLD WIDE SO WE END UP WITH I SUBSTANTIAL EMILY THATIONOT VOLUME OF AVAILABLE DECISION AIDS AS I MENTIONED BEFORE, EBSCO HEALTH HAS PARTNERED WITH OPTION GRID TO SCALE PRODUCTION OF EVIDENCE-BASED PATIENT DECISION AIDS TO MEET NATIONAL AND GLOBAL NEEDS. AND MANY MEMBERS OF THE SHARED DECISION MAKING COMMUNITY AND ECOSYSTEM ARE INTERESTED IN DEVELOPING STANDARDS FOR HOW TO DEAL WITH THE ACCURACY OR EVIDENCE COMPONENT OF PATIENT DECISION AID DEVELOPMENT THAT ON 1 HAND CAN REDUCE THE PROLIFERATION OF UNTRUSTWORTHY DECISION AIDS AND ON THE OTHER HAND CAN BECOME A BASIS FOR HOW GROUPS CAN WORK TOGETHER AND MAKE IT A SHAREABLE AREA FOR DEVELOPMENT. SO IN THE ARENA OF KEY INFORMATION FOR CLINICAL TRIAL INFORMED CONSENT, WHICH OF COURSE IS NOT SCALED YET BECAUSE THIS IS JUST A FEW DEVELOPMENT TO MAKE THIS EXPECTATION, GETTING THE KEY INFORMATION RIGHT IS GOING TO BE A LARGE EFFORT. MANY CLINICAL TRIAL DEVELOPERS COULD BE ASKED TO REPRODUCE THE EFFORT AT A CONSIDERABLE WASTE OF LIMITED RESOURCES. SOME COMPONENTS OF KEY INFORMATION HAVE TO BE ABSOLUTELY UNIQUE FOR THAT SPECIFIC PROTOCOL BUT SOME COMPONENT ARE POTENTIALLY SHAREABLE AND COULD LEVERAGE THE WORK OF OTHERS. I DON'T THINK THAT'S REALISTIC TO SAY HERE'S EXACTLY HOW THAT'S DONE BETWEEN NOW AND JULY 1 BUT SHARE THIS AS SOMETHING THAT COULD BE USEFUL TO CONSIDER FOR FURTHER DEVELOPMENT AS THIS UNFOLDS. SO REAL RECOMMENDATIONS FOR KEY INFORMATION OR RECOMMENDATIONS, HOW DO YOU MAKE THIS KEY INFORMATION REAL, RELEVANT? INCLUDE THE RISKS AND BENEFITS OF THE ALTERNATIVES. EASILY OOBD, ATTENTION TOTD READING--ATTENTION TO READING LEVEL AND PRESENTATION OF INFORMATION FOR COMPARISONNINGS BETWEEN OPTIONS, THE NEXT SPEAKERS WILL SHOW YOU SOME OTHER VISUALLY APPEALING FORMATS FOR PRESENTATIONS BUT AGAIN MAKING IT EASILY UNDERSTOOD AND FOCUSING ON WHAT'S RELEVANT. AND ACCURACY, AVOID CONFLICTS OF INTEREST IN DEVELOPING INFORMATION, SEARCH FOR ALL RELEVANCE AND CRITICALLY APPRAISE IT TO DETERMINE THE BEST ANSWERS AND KEEP ACCURACY IN MIND WHEN SIMPLIFYING THE LANGUAGE TO MAKE IT EASILY UNDERSTOOD. AND THEN LIMITED EFFORT, DEVELOP WAYS TO REUSE THE EFFORT, ESPECIALLY WHEN SUMMARIZING NONUNIQUE ANSWERS SUCH AS THE STANDARD TREATMENT ALTERNATIVES. DO YOU WANT TO HAVE THE OTHER SPEAKERS NOW AND THEN QUESTIONS? >> WELL I WAS GOING TO SUGGEST SINCE YOU'RE STANDING THERE AND THE OTHER SPEAKERS ARE REMOTE THAT WE ACTUALLY TAKE SOME QUESTIONS, A COUPLE MINUTES OF QUESTIONS NOW IF PEOPLE HAVE THEM. WE WILL COME BACK TO QUESTIONS FOR THE PANEL, TOO, AT THE END. SANDY? >> I LIKE YOUR TABULAR FORMATS--SORRY I'M NOT VERY GOOD AT THIS--I LIKE YOUR TABULAR FORMAT VERY WELL BUT 1 THING I WAS WONDERING ABOUT, INFORMATION YOU CHOSE TO PROVIDE UNDER THE NO TRIAL COLUMN, THERE'S NO INFORMATION ABOUT THE RISK OF DEATH AND I WAS WONDERING IF THAT WAS AN EXPLICIT DECISION OR JUST YOU PUT THIS TOGETHER QUICKLY AND YOU DIDN'T INCLUDE THAT? IT IS--WHAT ARE THE BENEFITS TO ME, IN ALL OF THE COLUMNS YOU SORT OF TALK ABOUT DEATH LIKELY TO OCCUR? I THINK IT'S THERE, SANDY IN NO TRIAL NO TREATMENT--BUT UNDER WHAT ARE THE BENEFITS TO ME, DEATH OCCURS BY 24 MONTHS IN 1 IN 2 MENCH. DEATH OCCURS FOR 1 OR 2 MEN. IF YOU LOOK IN THE COLUMN, SO TRIAL, NO TREATMENT, THERE IS NO ANALOGOUS TREATMENT THERE. I WAS WONDERING IF THAT WAS AN EXPLICIT DECISION OR-- >> NO, YOU ARE CORRECT IN THAT IS THE RESULT OF HAVING VERY LIMITED TIME. THIS KEY INFORMATION EXAMPLE WAS PUT TOGETHER IN A NUMBER OF HOURS NOT IN A NUMBER OF DAYS OR WEEKS AND THAT'S WHY I SAID AT THE BEGINNING IF DOING THIS FOR REAL, IT WOULD HAVE A BIT MORE OF THAT ATTENTION SO I WAS ABLE TO FIND THE DATA QUICKLY FOR THE EVIDENCE OF WHAT IS THE EXPECTED OR, YOU KNOW MEDIAN SURVIVAL IN THIS CASE AND IDEALLY YOU WOULD SEEK THE MEDIAN SURVIVAL WITHOUT TREATMENT AND PUT THAT IN HERE. AND IT WOULD JUST TAKE A BIT MORE TIME TO FIND THAT EVIDENCE AND PULL IT TOGETHER THAN I HAD IN THE PAST WEEK. SO, THAT--THAT IS WHAT WE DO IN TRYING TO DO THIS FOR OTHERS AND THAT'S PART OF WHY IT DOES TAKE SOME RESOURCES TO BE ABLE TO GET THAT YOU KNOW ACCURATE AND INFORMATIVE-- >> I HAVE 1 MORE QUESTION IF I MAY. ONE OF THE THINGS THAT I DON'T SEE HERE, BUT THAT I DO SOMETIMES SEE IS FUNCTIONAL IMPACT. IN OTHER WORDS YOU MAY HAVE LOW VISION, FOR EXAMPLE, AND THE FUNCTIONAL IMPACT OF THAT IS THAT YOU YOU ARE UNABLE TO DRIVE, OR YOU ARE UNABLE TO RECOGNIZE PEOPLE AND HERE YOU HAVE ALL OF THESE SIDE EFFECTS, FUNCTIONAL IMPACT OF WHICH MIGHT BE THAT YOU ARE LIVING WITH SUBSTANTIAL PAIN, THAT YOU ARE CONFINED TO BED, THAT YOU ARE UNABLE TO WORK. SO I'M WONDERING IF YOU THINK ABOUT THOSE FUNCTIONAL IMPACTS AT ALL IN THINKING ABOUT THESE ALTERNATIVES? >> YES. FUNCTIONAL IMPACT IS 1 OF THE MOST IMPORTANT QUESTIONS TO PATIENTS AND IF I--WE DIDN'T SEE IT WITH THE ATRIOLE FIB ROUGH ATOMALATION EXAMPLE, BUT IF I SHOW YOU NEARLY ANY OTHER EXAMPLE, THEY INVOLVE SURGICAL TREATMENTS AND IT'S OFTEN A VERY KEY QUESTION WHEN CAN I RETURN TO DRIVING? WHEN CAN I RETURN TO WORK? WHAT'S MY FUNCTIONAL IMPACT? IN THIS EXAMPLE, PART OF IT WAS IN THE LIMITED TIME THERE WAS NOT CLEAR EVIDENCE ABOUT THAT. IN THE 17 PAGE INFORMED CONSENT DOCUMENT, I DIDN'T SEE INFORMATION ABOUT THAT. AND REALISTICALLY IN THIS PARTICULAR EXAMPLE, THAT MAY BE MORE DEPENDENT ON THE PATIENT AND WHAT THAT DISEASE IS DOING FOR THEM FUNCTIONALLY, THEN THE DIFFERENCE BETWEEN TREATMENTS AND WE MAY NOT HAVE A CLEAR SENSE OF FUNCTIONAL IMPACT OF THE TREATMENT AS A HARM OR BENEFIT ON FUNCTIONAL IMPACT AS A BENEFIT. SO IN THIS PARTICULAR EXAMPLE IT MAY BE THAT COULD BE EXPLORED AND THEN DETERMINED NOT TO MAKE IT THE KEY INFORMATION BUT IT'S A VERY IMPORTANT QUESTION TO BE CONSIDERING IN ALL CASES. I WAS JUST GOING TO ADD THAT IN CANCER, THEY USE PERFORMANCE STATUS TO MEASURE HOW WELL YOU CAN ENGAGE IN YOUR ACTIVITIES OF DAILY LIVING AND HAVING READ THIS PROTOCOL, I THINK YOU HAD TO HAVE A HIGH PERFORMANCE STATUS SO CAN YOU TAKE PART IN THE TRIAL. I DON'T KNOW IF THAT IS RELEVANT TO WHAT YOU ARE ASKING. YOU ALSO FREQUENTLY SEE, NO TRIAL, NO TREATMENT BUT YOU SEE SUPPORTIVE CARE BEING OFFERED COMFORT CARE. >> I'M WONDERING IF YOU CAN TALK A LITTLE BIT ABOUT HOW TO CONVEY UNCERTAINTY--NOT THAT THERE'S NOT UNCERTAINTY IN THE CONTEXT OF CLINICAL CARE--BUT IT'S 1 OF THE BIGGEST CHALLENGES I THINK IN COMMUNICATING TO POTENTIAL PARTICIPANTS IN CLINICAL TRIALS. IT'S JUST WHAT WE DON'T KNOW. AND SO IN THIS CHART, YOU KNOW YOU SEE LANGUAGE ABOUT YOU MAY AS OPPOSE YOU WILL OR MORE CERTAIN BASED LANGUAGE BUT I'M WONDERING IF YOU HAVE ANY THOUGHTS ABOUT HOW TO TRANSLATE THIS INTO THE RESEARCH SETTING IN CONTEXT OF LACK OF DATA? >> RIGHT. WE HAVE--WHEN WE KNOW FOR SURE HAVE HIGH CERTAINTY WHICH IS RELATIVELY UNCOMMON, WE WILL USUALLY USE PHRASES LIKE YOU WILL. WHEN WE HAVE SOME UNCERTAINTY, WE WILL OFTEN SAY THINGS LIKE, YOU MAY. śMIGHT MOVE TO YOU MIGHT ORWE BETTER OFF MORE EXPLICITLY SAYING, IT IS VERY UNCERTAIN. SO IN THIS EXAMPLE, YOU KNOW WE JUST SAID WE DO NOT KNOW. RIGHT? AND GOT TO THAT EXTREME. WE ALSO WILL OFTEN SAY THINGS LIKE UP TO INSTEAD OF GIVING A SPECIFIC NUMERICAL RESULT, THERE MAY BE A RANGE. AND USE OTHER ABOUT OR UP TO, IT'S ANOTHER WAY OF EXPRESSING UNCERTAINTY WITH THE QUANTITATIVE ASPECT OF THINGS. BUT IT IS CHALLENGING TO BE EASY TO UNDERSTAND AND EXPRESS UNCERTAINTY CLEARLY, BUT ALSO VERY IMPORTANT TO DO. SO THAT'S--THAT'S WHAT WE'VE TENDED TO USE AS PHRASING GETTING THESE COMPLEX CONCEPTS TO FIT IN THIS SPACE, TO KEEP IT EASY TO UNDERSTAND, WE LIMIT OURSELVES TO ACTUALLY FIT ON 1 PAGE FOR OUR TYPICAL 1S, I KNOW THIS 1 MADE IT TO 2 PAGES, TO ALSO ADDRESS THE TRIAL PARTICIPATION, BENEFIT TO SOCIETY TYPE QUESTIONS AND ANSWERS AND WE LIMIT OURSELVES TO 1 PAGE WITH 12.5 TO BE READABLE FOR MOST OF THE PATIENTS. SO WE HAVE VERY LIMITED SPACE FOR EXPRESSING UNCERTAINTY AND THAT'S THE BEST WE HAVE AT THE MOMENT. BUT I THINK WE SHOULD EXPLORE THAT EACH FURTHER TO GET IS THAT THE BEST WAY FOR PEOPLE TO UNDERSTAND IT. >> YEAH, FOLLOWING UP ON THAT, I'M STRUCK IN THE FIRST PAGE BEFORE YOUR CHARTS THAT YOU SAY DOXATAXIL COULD KILL THE CANCER. WHICH YOU DIDN'T TALK ABOUT COULD AS 1 OF YOUR OPTIONS FOR DESCRIBING UNCERTAINTY AND COULD KILL THE CANCER SEEMS A PRETTY STARK AND ATTRACTIVE WAY OF DESCRIBING WHAT PATIENTS WHO ARE CONSIDERING BEING SUBJECTS WOULD WANT FROM THIS TRIAL AND I JUST WONDERED ABOUT THAT CHOICE OF PHRASE GIVEN THE DATA AVAILABLE. YEAH, SO COULD KILL OR MAY KILL. I'M MOSTLY THINKING ABOUT KILL ACTUALLY. >> OKAY, NOT THE UNCERTAINTY PART OF THE WORD. >> WELL BOTH. >> SO THE COULD IS UNCERTAINTY BEING PLACED IN FRONT OF IT, IT'S NOT SAYING IT WILL DEFINITELY KILL THE CANCER, COULD WAS USED IN INSTEAD OF MAY IN THAT CONTEXT, KILL THE CANCER IS IN AN EARLIER VERSION OF THIS, I HAD IT PHRASED AS KILLING CANCER CELLS AND IN THEN FURTHER EDITING IT TO GET IT DOWN TO A SIXTH GRADE READING LEVEL ENDED UP REMOVING THE CONCEPT OF CELLS AND THAT'S HOW THE WORDING GOT LEFT THERE. AND NOT A LOT OF EFFORT HAS GONE INTO HOW TO COME UP WITH THAT PHRASING. THIS WAS JUST DURING THAT. SO WHETHER THAT IS THE PREFERRED PHRASING, OPTIMAL PHRASING FOR, YOU KNOW PATIENTS AND CLINICIANS IN GIVING FEEDBACK ON THOSE, DOES REACH THE BEST UNDERSTANDING, I'D LIKE TO SEE SOME MORE FEEDBACK ON IT. BUT THAT'S HOW I GOT THERE. >> LESLIE LAST QUESTION. >> SO, IN YOUR DESCRIPTION OF HOW YOU DO IT FOR WHAT YOU DO IN TERMS OF CLINICAL DECISION MAKING, YOU TALKED ABOUT WHY YOU CHOOSE TO, YOU KNOW OUT OF A HUNDRED PEOPLE OR ANYTHING, AND BECAUSE THERE HAVE BEEN DEBATES ABOUT HOW DO WE COMMUNICATE THAT, I WOULD LIKE TO HEAR MORE ABOUT--BECAUSE THAT WAS THE PRODUCT AS I UNDERSTAND IT, OF ACTUALLY TESTING IT AMONG PATIENTS SO THAT--HOW THAT ACTUALLY IS HELPFUL FOR PATIENTS TO UNDERSTAND RISKS, SIDE CENTER FOR EXCELLENCE ON AGINGS AND THOSE THINGS, YOU KNOW, I'M UNDERSTANDING, YOU FOUND THAT MOST UNDERSTANDABLE, IS THAT RIGHT WHEN YOU TESTED IT WITH PATIENTS. >> RIGHT. NOW THERE'S--LET'S SAY THE NONIMAGE APPROACH, AND THE IMAGERY BASED APPROACH. WITHIN THE NONIMAGE APPROACH THERE'S STILL MANY WAYS OF CONVEYING THE RISKS, RELATIVE RISKS, PERCENTAGES AND SO MANY THINGS. AND WITHIN THAT SETTING, THE OUT OF A HUNDRED, YOU KNOW SO YOU HAVE WHOLE PEOPLE, IS A LOT EASIER WELCOMING MORE UNDERSTANDING. THERE'S A SUBSTANTIAL AMOUNT OF RESEARCH THAT HAS BEEN LOOKING AT THIS AREA IN THE PAST 10 YEARS. THEN SEPARATELY, THERE ARE APPROACHES WITH IMAGES, BAR GRAPHS, IKAN--KANAA RAYS, PIE CHARTS AND SO ON. WE ARE STILL LOOKING AT YOU KNOW PARTICIPATING IN AND LOOKING FORWARD TO THE RESULTS OF RESEARCH, THE ANSWERS ARE NOT OUT AS FAR FOR WHICH IMAGE APPROACH IS MORE UNDERSTANDABLE AND IMAGE VERSUS NONIMAGE SO BASED ON WHERE OPTION GRID HAS BEEN AND WHERE WE ARE RIGHT NOW, WE ARE USING THE BEST OF THE NONIMAGE APPROACH BUT LOOKING FORWARD TO ADDING IMAGERY AND ONCE WE ADD IMAGERY, IS IT PEOPLE AND HOW MANY OF THEM ARE COLORED IN AND IF SO, IS IT OUT OF 10 PEOPLE, A HUNDRED PEOPLE, OUT OF A THOUSAND PEOPLE. WHICH IS THE BEST APPROACH? WE REALLY DON'T KNOW AT THAT LEVEL. BUT IT MAKES A LOT OF SENSE THAT HIGHLY STATISTICAL EXPLANATIONS THAT ARE COMMONLY USED IN MEDICINE, DOCTORS HAVE TROUBLE UNDERSTANDING THEM ENOUGH TIMES THAT TO EXPECT, YOU KNOW A SIXTH GRADER TO UNDERSTAND IT, YOU COULD SEE HOW X-NUMBER OF PEOPLE OUT OF A HUNDRED WILL BE EASIER THAN THOSE OTHER METHODS. SO THANK YOU VERY MUCH. I WOULD JUST LIKE TO NOTE THAT THE SUGGESTION TO REUSE AND TO SORT OF CREATE A SHAREABLE RESOURCE OF THESE THINGS, ACTUALLY WORKS WELL WITH THE REQUIREMENT THAT WILL COME WITH THE UPDATED RULE TO POST CONSENTS SO THAT WE WILL ACTUALLY HAVE A LIBRARY THAT WILL BE PUBLICLY AVAILABLE. WE WILL SEE HOW THAT ALL WORKS OUT. IT'S NOT THE MOST STRUCTURED APPROACH, BUT IT WILL BE A NICE START. >> ANOTHER PART OF IS THE TRIAL, THE PROTOCOL, THE QUESTION FOR THE TRIAL IS DIFFERENT BUT THE STANDARD TREATMENT OPTIONS, WHATEVER YOU HAVE FOR THE BENEFITS, RISKS AND THINGS FOR THAT PART MIGHT BE REUSABLE. >> ABSOLUTELY. THANK YOU. AND I THINK WE SHOULD PUT THE ISSUE OF IMAGES VERSUS WORDS SORT OF ON HOLD. PERHAPS WE CAN DISCUSS THAT FURTHER AT THE END OF THE PANEL. THANK YOU. BEFORE I TURN THIS OVER TO DR. DR. WOLOSHIN AND DR. SCHWARTZ AND MAKE SURE THEY'VE BEEN ABLE TO HEAR EVERYTHING SO FAR? >> YES WE'VE BEEN LISTENING AND HEARING EVERYTHING. >> GREAT. SO YOU'RE UP NEXT. >> OKAY, CAN YOU SEE OUR SLIDES? >> WE CAN. >> SO SHALL WE GET STARTED? >> YEAH. >> OKAY. WELL, SO FIRST OF ALL WE REGRET THAT WE CAN'T BE THERE WITH YOU GUYS. WE ARE STUCK HERE IN THE SNOW OF VERMONT, BUT WE WILL DO OUR BEST I WILL START WITH DISCLOSURES, LISA AND I ARE MARRIED TO EACH OTHER WE SHOULD MAKE THAT CLEAR AND WE ALSO SERVE AS EXPERT WITNESSES IN TEST OOF THE ROAN LITIGATION. SO IT'S WIDELY RECOGNIZED THAT INFORPED CONSENT DOCUMENTS ARE TOO LONG AND TECHNICAL. OR EXPERIENCE DEVELOPING THE DRUG FACTS BOX, BRIEF SUMMARIES OF FREE RADICALS SCRIPGZ DRUG LABELS AND FDA REVIEWS DEMONSTRATE THE FEASIBILITY AND VALUE OF EXTRACTS AND PRESENTING KEY INFORMATION ABOUT DRUGS TO DOCTORS AND PATIENTS. OUR APPROACH HAS BEEN ENDORSED BY FDA'S RISKAD VISERY COMMITTEE AND MENTIONED IN THE AFFORDABLE CARE ACT BUT HASN'T BEEN ADOPTED BY FDA YET. IT IS CURRENTLY UNDER CONSIDERATION BY THE EUROPEAN MEDICINE AGENCY: THE IDEA CAME FROM THE NUTRITION FACT BOX, WE WERE HAVING BREAKFAST 1 DAY AND NOTICED THAT COCOA CRISPIES LIKE ALL PRODUCTS HAVE FACTS ON THE SIDE AND WE THOUGHT THIS WAS AN INTERESTING ATTEMPT TO CONVEY IMPORTANT INFORMATION TO PATIENTS, TO CONSUMERS IN A TABULAR FORM IF YOU CAN DO THIS FOR COCO CRISPIES WHY CAN BE THE YOU DO THIS FOR DRUGS? NOT LIST THE INGREDIENTS, BUT LIST THE BENEFITS AND HARM SO PEOPLE CAN MAKE AN INFORMED DECISION. AFTER MANY YEARS OF WORK, WE DEVELOPED THIS FORMAT CALLED THE DRUG FACTS BOX AND THIS IS WHEN IS LOOKS LIKE THIS, IS AN EXAMPLE OF LUNESTA, WHICH WAS HEAVILY ADVERTISES, IT WAS THE [INDISCERNIBLE]. THE BOX HAS 2 PARTS, THE FIRST PART IN IS A NARRATIVE, DESCRIPTIVE INFORMATION, BUT THE HEART OF THE BOX IS THE DATA TABLE. THIS TABLE PRESENTS DATA ON HOW WELL THE DRUG WORKS FOR THE ADVERTISED INDICATION AND ALSO ABOUT THE IMPORTANT HARMS AND IT'S SORTED INTO LIFE THREATENING AND SYMPTOM SIDE CENTER FOR EXCELLENCE ON CENTER FOR EXCELLENCE ON CENTER FOR EXCELLENCE ON AGINGS. THE SOURCE FOR INFORMATION--THE KEY INFORMATION COMES FROM THE FDA IMPROVAL DOCUMENTS AND THAT'S ALL THE MATERIAL THAT FDA CONSIDERS AND THERE ARE REPORTS ON HOW THEY ANALYZE THE INFORMATION THAT THE DRUG COMPANIES PROVIDED. AND THESE ARE LONG, LONG DOCK YOU WANTS. AND THEN THE FDA APPROVED LABELS OF PRODUCT INFORMATION THAT'S TISSUE PAPER INSERT THAT COMES WITH DRUGS. IN INFORMATION IS TYPICALLY DISTILLED DOWN INTO THE BRIEF SUMMARY WHICH IS THE SECOND PAGE OF DRUG ADS WHICH IS TYPICALLY, THE ONLY THING THAT REALLY SEES THE LIGHT OF DAY. THE PROBLEM WITH THE BRIEF SUMMARY IS THAT--AND THIS IS IMPORTANT KEY INFORMATION AND OUR IDEA WAS TO SUBSTITUTE THAT WITH THE DRUG FACTS BOX AND WE WOULD BE ABLE TO PROVIDE BALANCED INFORMATION ABOUT DRUG BENEFITS AND HARMS SO PEOPLE COULD BE CLEAR ABOUT HOW WELL THE DRUG WORKS. SO THIS MORNING WE WILL DRAW ON OUR EXPERIENCE WITH DRUG FACTS BOXES FOCUS ON SPECIFIC KEY INFORMATION ELEMENTS FOR INFORMED CONSENT AND HOW TO IMPLEMENT THEM. WE WERE GIVEN THE INFORMED CONSENT FORM FOR THE CHARTER TRIAL AND SO OUR EXAMPLE IS BUILT ON THAT. OUR FIRST SUGGESTION IS TO ADD 2 ELEMENTS UNDER THE "WHY IS THE STUDY BEING DONE" HEADER WHICH IS A STANDARD FEATURE OF INFORMED CONSENT FORMS. SO SPECIFICALLY WHAT IS THE SCIENCE BEHIND THE STUDY, AND I'M JUST GOING TO READ OUR ATTEMPT OUR FIRST DRAFT ATTEMPT TO PROVIDE THIS INFORMATION. SO THE NEW IDEA IS TO START CHEMO THERAPY AT THE SAME TIME AS HORMONE PLOKING INSTEAD OF JUST WHEN JUST CANCER PROGRESSES. WHY MIGHT IT HELP? A SMALL TRIAL SHOWED THAT CHEMO THERAPY WITH HORMONE BLOCKING SLOWED DOWN THE PROGRESSION PSA INCREASE BUT IT DID NOT PROLONG LIFE? WHY MIGHT IT NOT HELP? SOME RESEARCHERS WORRY THAT STARTING BOTH DRUGS TOGETHER MAY LAKE CHEMO THERAPY LESS EFFECTIVE. THE PURPOSE OF THIS STUDY IS TO SEE IF STARLIGHTING A DIFFERENT CHEMO THERAPY THAN THE 1 IN THE SMALL TRIAL, DOXOTEXTILE, HELPS MEN LIVE LONGER THAN STARTING HORMONE BLOCKING ALONE. IT'S BEEN PROVE TO PROLONG LIFE WHEN GIVEN PROGRESSION. BOTTOM LINE NO 1 KNOWS THE ANSWER, THAT IS WHY THE TRIAL IS BEING DONE. THE SECOND HEADER THAT WE PROPOSED IS WHAT IS THE TRACK RECORD. NOW IN THIS CASE, THE DRUGS IN THE TRIAL ARE FDA APPROVED. WE THINK THE IMPORTANT INFORMATION TO PROVIDE HERE WOULD BE WHEN WAS IT APPROVED, IS IT APPROVED FOR THIS SPECIFIC INDICATION? AND IF SO, WHEN? AND THEN TO MENTION IF THE DRUG HAD ACCELERATOR APPROVAL AND IF SO, TO BE CLEAR ABOUT WHAT THE IMPORTANT OPEN QUESTIONS ARE. FOR DOXATAXILY TAX ILLEGALS COULD READ LIKE THIS. D OCETAXEL, WAS USED BY LARGE NUMBERS OF PEOPLE OVER A LONG TIME, THE EMERGENCE OF IMPORTANT SIDE EFFECTS IS LESS LIKELY THAN WITH NEW DRUGS. HERE'S HOW IT WOULD READ IF WE'RE DOING WITH A NEWLY APPROVED DRUG. SO A NEW DRUG WAS APPROVED BY FDA FOR CANCER, CLINICAL TRIALS BEFORE APPROVAL GENERALLY STUDY A LIMITED NUMBER OF PEOPLE FOR A SHORT PERIOD OF TIME. IMPORTANT SIDE EFFECTS MAY EMERGE AFTER A NEW DRUG IS THE ON THE MARKET WHEN LARGER NUMBERS OF PEOPLE WITH OTHER CONDITIONS AND ON OTHER MEDICATIONS HAVE USED THE DRUG. THIS NEW DRUG IS THE FIRST DRUG WITH THIS MECHANISM EXPERIENCE THIS PARTICULARLY LIMITED. AND FINALLY A LOT OF TRIALS DEAL WITH DRUGS THAT ARE STILL IN DEVELOPMENT IN WHICH CASE, MINIMUM OF INFORMATION TO PROVIDE AT LEAST WOULD BE HOW MANY PEOPLE HAVE TAKEN IT AND FOR HOW LONG? TEXT WE SUGGEST A NEW HEADER WHICH HELPS PEOPLE APPRECIATE THE TRADE OFFS FROM THEIR OWN PERSPECTIVE. SO WHY WOULD YOU WANT TO BE IN THE STUDY? STUDYING HORMONE PLOKING ALONE MEANS IT'S LIKELY YOUR CANCER WILL PROGRESS OVER THE NEXT FEW YEARS OVER WHICH YOU WILL NEED CHEMO THERAPY. THE TIME OF PROGRESSION DEPENDS ON HOW MUCH THE CANCER HAS ALREADY SPREAD. USUALLY 1 YEAR IN A LOT OF SPREAD AND 2-3 YEARS WITH LESS SPREAD. DOCETAXOL CHEMO THERAPY HAS SIDE EFFECTS SOME BOTHERSOME AND LIFE THREATENING. IT'S ALSO INCONVENIENT, TRAVEL TIME, TEST, AND INFUSION EVERY 3 WEEKS. STARTING HORMONE PLOKING MEANS GIVING UP QUALITY TIME NOW, 5-6 MONTHS FOR CHEMO THERAPY AND RECOVERY. IF STARTING CHEMO THERAPY HELPS, IT MAY BE WORTH IT, THE CANCER WOULD TAKE LONGER TO PROGRESS AND YOU WOULD LIVE LONGER AND IT MIGHT NOT HELP OR MAKE QUALITY OF LIFE WORSE BECAUSE OF RARE LONG LASTING SIDE EFFECTS EMPLOY IF YOU AND YOUR DOCTOR WOULD BE OKAY WITH TREATMENT, YOU MIGHT WANT TO BE IN THE TRIAL. OF COURSE WE THINK IT'S IMPORTANT TO CONSIDER BOTH SIDES SO WE WOULD ALSO ADD WHY WOULD YOU NOT WANT TO BE IN THE TRIAL? YOU AND YOUR DOCTOR HAVE A STRONG FEELING ABOUT STARTING CHEMO THERAPY NOW OR LATER, YOU MIGHT NOT WANT TO TAKE PART. YOUR DOCTOR CAN START HORMONE PLOKING WITH CHEMO THERAPY NOW OR LATER EVEN IF YOU ARE NOT IN THE STUDY. OTHER REASONS FOR NOT TAKING PART ARE, HAVING IMPORTANT LIFE EVENTS THE NEXT 6 MONTHS AND YOU DON'T WANT TO BE TIRED FROM CHEMO THERAPY OR BEING MUCH OLDER OR HAVING OTHER SERIOUS MEDICAL PROBLEMS AND BEING MORE CONCERNED WITH QUALITY OF LIFE RIGHT NOW. A RELATED HEADER WOULD BE TO BE EXPLICIT ABOUT THE AVAILABILITY OF THE TREATMENT OUTSIDE OF THE TRIAL. CAN I GET THIS TREATMENT OUTSIDE THE TRIAL? YES. FDA AS APPROVED DOXETAXEL AND HORMONE BLOCKING DRUGS, AND YOUR DOCTOR CAN PRESCRIBE THIS ONLY WHEN THE CANCER PROGRESSES, THAT'S CURRENT RECOMMENDATION O AT THE SAME TIME AS HORMONE PLOKING TREATMENTS-OF BLOCKING TREATMENT STARTS ALTHOUGH THE BENEFITS ARE UNKNOWN. INSURANCE COVERAGE CAN BE AN IMPORTANT BARRIER, IF THE DRUG'S EXPENSIVE OR NOT APPROVED FOR THE CONDITION, SO WE WOULD INCLUDE A TAB ABOUT INSURANCE COVERAGE. HERE INSURANCE COVERAGE NOT LIKELY TO BE A MAJOR PROBLEM SINCE DOCETAXEL IS NOT APPROVED BUT CHECK WITH YOUR INSURANCE COMPANY TO FIND OUT. >> SO OUR NEXT SUGGESTION IS TO MAKE EVEN BETTER USE OF THE DESEEN FIGURE. SO FOR INSTANCE THE FIGURE COULD BE MORE SPECIFIC TO HIGHLIGHT THE ENTRY CRITERIA. SO A MAN WITH PROSTATE CANCER THAT SPREAD BEYOND THE PROSTATE WHO WERE STARTING HORMONES OR HAVE TAKEN IT FOR 2 YEARS OR LESS AND THEN SPECIFYING THAT YOU NEED TO HAVE METAAT THAT TIME STATIC DISEASE ON A CAT SCAN OR BONE SCAN DONE IN THE PAST 6 WEEKS, YOU NEED TO HAVE PLOOD DEOF THES SHOWING HIGH PSA AND GOOD LIVER KIDNEY FUNCTION AND GETTING FUNCTIONAL SIZE TO DR. VISIT AND PHYSICAL EXAM SHOWS YOU ARE ACTUALLY ACTIVE OR JUST RESTRICTIVE IN DOING HEAVY WORK AND THEN WE THOUGHT THE FIGURE COULD ALSO HELP TO GET RID OF THE TEXT AND EXPLAIN RANDOMIZATION AT THE SAM TIME. SO THE COMPUTER PROGRAM IS GOING TO DECIDE YOUR TREATMENT BY CHANCE AND YOU HAVE A 50% CHANCE OF GETTING EITHER TREATMENT. THEN THE FIGURE COULD ALSO EXPAND ON EXACTLY WHAT THE TREATMENT IS, AND THE BURDEN OF TREATMENT. SO IF YOU WERE RANDOMIZED HORMONE IN CHEMO THERAPY, THAT WOULD BE CHEMO THERAPY FOR 18 WEEKS AND THE CHEMO THERAPY, IT TELLS YOU IT TAKES AN HOUR INFUSION, SOMETIMES DRUGS CAN BE MANY HOURS SO THAT'S IMPORTANT TO KNOW IS THE FREQUENCY AND WHAT THE PREMEDS YOU HAVE TO TAKE ARE. AND THEN OF COURSE THERE'S THE BURDEN OF TESTING AND FOLLOW UP AND TO MAKE THAT EXPLICIT WITHIN THE STUDY DESIGN FIGURE. ANOTHER FEATURE OF THIS TRIAL WHICH WE THOUGHT WAS REALLY IMPORTANT WAS THAT WHILE YOU'RE LEAVING THE INITIAL DECISION UP TO RANDOMIZATION OR CHANCE, THAT IN EITHER ARM, THAT IF THE CANCER PROGRESSES, THAT YOU AND YOUR DOCTOR COULD DECIDE WHAT TREATMENT TO HAVE SO THAT CAN YOU FOCUS THE DECISIONOT UPFRONT RANDOMIZATION BUT THAT YOU STILL GET TO CHOOSE AND TO BE CLEAR THE PROTOCOL WAS SUGGESTING DOCETAXOL, BUT IT DIDN'T REQUIRE THAT. BUT THEN YOU COULD ALSO HIGHLIGHT WHAT IS THE OUTCOME THAT THE INVESTIGATORS THINK WILL BE EFFECTIVE BY THE TRIAL. WHAT ARE THE PRIMARY OUTCOMES THAT SO THAT YOU CAN GIVE THE TRIAL DURATION AND THE PRIMARY OUTCOME SO PEOPLE CAN UNDERSTAND BOTH THE PURPOSE OF THE TRIAL AND WHAT THE HOPED FOR BENEFITS ARE. SO FINALLY, WE WOULD LIKE TO COME TO SIDE EFFECTS, WHICH HOW BAD AND HOW OFTEN WHEN WE THINK IS REALLY FUNDAMENTAL KEY INFORMATION. THIS IS HOW THE CHARTED TRIAL INFORMED CONSENT PRESENTS DOCETAXOL SIDE EFFECTS AND IF I WERE IN THE ROOM WITH YOU I WOULD ASK IF ANYONE HAD ANY COMMENTS AND I MIGHT EVEN GIVE YOU HINTS. THE WORD LIKELY, WHAT DOES IT MEAN? IT TURNS OUT THAT IT MEANS DIFFERENT THINGS TO DIFFERENT PEOPLE. SO IN 1 STUDY PATIENTS WERE ASKED TO ASSIGN A PROBABILITY TO THE WORD LIKELY. ON AVERAGE, THE AVERAGE RESPONSE WAS THAT IT MEANT A 70% CHANCE BUT THERE'S A LOT OF VARIABILITY, SO SOME PEOPLE THOUGHT THAT LIKELY MEANT 20% AND SOME PEOPLE THOUGHT IT MENTORSHIP SKILL CERTAIN, A HUNDRED PERCENT. ANOTHER STUDY ASKED PHYSICIANS THE SAME QUESTION, INTERESTINGLY THEIR AVERAGE RESPONSE WAS ABOUT THE SAME, 70% BUT STILL A TREMENDOUS AMOUNT OF VARIABLES AND THAT'S WHY WE INVENTED NUMBERS TO AVOID THE VARIABLE INTERPRETATION OF WORDS AND THEN I THINK AS DR. ALPERS'S ALREADY TALKED ABOUT IS HOW DO YOU PRESENT THOSE NUMBERS. SO WE--LOOKING AT THIS FORM, UNDER LIKELY, SO LOWERED RED PLOOD CELL COUNT OR ANEMIA WAS ACCORDING TO THE PRODUCT LABEL FOR THE PROOF THEASTY CANCER INDICATION, 67% OF PEOPLE HAD ANY ANEMIA, BUT LOW PLATELET COUNT WAS ONLY 3 PERCENT. SO HERE LIKELY MEANT ANYWHERE FROM 67%-3%. NOW NCI HAS A REALLY WONDERFUL CONSENT FORM TEMPLATE WHICH I THINK HAS TRIED TO WORK AT STANDARDIZING HOW THE WORD LABELS ARE USED AND SO, COMMON IS 21% TO A HUNDRED%. OCCASIONALLY 4-20 AND RARE IN LESS THAN 3%. SO IT'S NOT CLEAR THAT THIS PARTICULAR FORM USE THIS STANDARD BUT STILL, INCREDIBLY WIDE RANGES IN COMMON AND IT'S UNCLEAR THAT PEOPLE WOULD KNOW WHAT THAT ACTUALLY MEANT. SO WE ACTUALLY HAVE DONE SOME STUDIES ABOUT THOU TO PRESENT THE NUMBERS, HOW TO PRESENT THE ABSOLUTE RISK BECAUSE THERE'S A LOT OF STRONG BELIEF ABOUT HOW TO PRESENT THE NUMBERS AND WHEN WE STARTED TO INVESTIGATE FOR THE DRUG BOX ABOUT WHAT WAS KNOWN, IT TURNS OUT THERE'S WEAK DATA ABOUT WHAT NUMERICAL FORMAT TO USE. SO WE DID RANDOMIZED TRIAL IN NEARLY 3000 PEOPLE WHERE WE PRESENTED DRUG BOXES USING THE NUMBERS IN DIFFERENT FORMATS. AND WHAT WE FOUND WAS THAT PERCENTS ARE BEST. WE FOUND THAT THE FREQUENCY FORMAT X-AND A THOUSAND IS A CLOSE SECOND. WE HAD ORIGINALLY STARTED BECAUSE WE DIDN'T KNOW THE ANSWER GIVING THE COMBINATION AND WHAT WE LEARNED WAS THAT THAT DIDN'T IMPROVE COMPREHENSION AND REALLY JUST ADDED CLUTTER. AND THE OTHER THING THAT WE LEARNED WHICH WAS SURPRISING BECAUSE WE HAD SUSPECTED THAT PEOPLE HAD A LOT OF TROUBLE UNDERSTANDING PERCENTAGES LESS THAN 1, WAS WE HAD 7 DIFFERENT QUESTIONS ABOUT LOW PROBABILITY EVENTS AND COMPREHENSION WAS REALLY THE SAME IF YOU GAVE INFORMATION IN THE DECIMAL PERCENT FORM VERSUS IN THE FREQUENCY PERCENT FORM. THAT DIDN'T SEEM TO BE A PROBLEM. THE 1 OTHER FINDING WAS IF YOU CHANGE THE DENOMINATORS SO SOMETIMES YOU GO TO X AND A HUNDRED AND X AND A THOUSAND, WE FOUND THAT THAT WAS REALLY CLEARLY A BAD THING TO DO BECAUSE PEOPLE HAVE DENOMINATOR NEGLECT AND THAT IN OUR STUDY, AND IN THE NUMBER OF OTHER STUDIES CREATES A LOT OF PROBLEMS IN TERMS OF COMPREHENSION. RECENTLY OUR FINDINGS WERE REPLICATED. THE GRADE EVIDENCE TABLES ARE SORT OF LIKE DRUG BOXES BUT THEY'RE PRESENTING THE FINDINGS FROM SYSTEMATIC REVIEWS AND THEY ALSO CAME TO THE CONCLUSION THAT ACTUALLY EVEN IN A PHYSICIAN OR SORT OF PROFESSIONAL AUDIENCE THAT PERCENTAGES WERE BETTER UNDERSTOOD THAN FREQUENCY FORMAT. SO YOU KNOW, TYPICALLY FOR MANY NEW DRUGS, YOU MAY NOT KNOW THE BENEFITS AND THE TRIALS BUT THERE WILL BE A LOT OF SIDE EFFECTS AND A LOT OF NUMBERS SO WHEN WE DEVELOPED OUR DRUG BOX, THE IMPORTANCE QUESTION WAS COULD PEOPLE REALLY MAKE SENSE OF A LOT OF NUMBERS. SO WE DID A RANDOMIZED TRIAL OF 231 PEOPLE AND IT WAS A REAL WORLD CHALLENGE. WE WERE SHOWING THEM PEOPLE DIRECT TO CONSUMERADS FOR 2 DRUGS THAT WERE TREAT BEING THE SAME CONDITION FOR HEART BURN. ONE IS A PROTON PUMP INHIBITOR AND THE OTHER WAS AN H2 BLOCKER. AND THE DRUGS HAVE SIMILAR SIDE EFFECTS BUT 1 IS SUBSTANTIALLY MORE EFFECTIVE. AND SO WE WANTED TO KNOW, CAN PEOPLE CHOOSE THE OBJECTIVELY BETTER DRUG IF THEY HAVE THE STANDARD INFORMATION WHICH IS JUST REALLY ADVERTISING BECAUSE THERE'S NO EXPLICIT STATEMENT ABOUT THE BENEFITS? OR COMPARE TO DATA TABLES AND COME TO THE RIGHT ANSWER? SO THIS WAS OUR PRIMARY OUTCOME, IF YOU COULD TAKE EITHER DRUG FOR FREE, WHICH DRUG WOULD YOU RATHER TAKE? IN THE STANDARD DIRECTOR CONSUMER AD, BUT WITH THE DRUG BOX 68% OF PEOPLE COULD CHOOSE THE BETTER DRUG, SO THIS REALLY HIT HOME TO US THAT IF YOU MAKE THESE NUMBERS ACCESSIBLE THEN PEOPLE CAN REALLY UNDERSTAND THEM AND INTERPRET THIS TO MAKE A DECISION. AND IN THIS CASE, THERE'S A RIGHT, ANSWER TOO. I WANT TO COME BACK TO THE CONSENT FORM. SO IT'S MORE THAN JUST THE FREQUENCY. THERE'S ANOTHER ISSUE HERE, SO IF YOU LOOK UNDER LESS LIKELY, THERE'S SORES IN THE MOUTH, ITCHING AND HEADACHING BUT RIGHT UNDERNEATH THAT IS LISTED FLUID AROUND THE HEART OR LUNGS WHICH IS I THINK MANY OF US WOULD AGREE NOT EQUALLY BAD. SO THE PROBLEM HERE IS THAT WHILE THE SIDE EFFECTS ARE SORTED ACCORDING TO FREQUENCY, THEY'RE NOT SORTED ACCORDING TO SERIOUSNESS AS WELL. SO WHAT WE TRIED TO DO IS USE OUR DRUG BOX APPROACH TO SAY HOW YOU COULD DO BOTH. SO YOU COULD AT THE FIRST LEVEL ORGANIZE BY YOU KNOW THE MOST DANGEROUS SIDE EFFECTS, SERIOUS SIDE EFFECTS AND THE SYMPTOM SIDE EFFECTS. AND THEN, YOU COULD ORGANIZE ACCORDING TO FREQUENCY WITHIN EACH 1 OF THE CATEGORIES. HERE'S WHAT THE SIDE EFFECT WOULD LOOK LIKE. AND IN THE FIRST CASE, AS IS OFTEN WITH THE RARE DANGEROUS SIDE EFFECTS, WE DON'T HAVE NUMBERS, IT'S UNCERTAIN ABOUT HOW OFTEN, BUT FOR MANY OF THE SIDE EFFECTS WE DO HAVE NUMBERS BECAUSE THEY REPORT THOSE SIDE EFFECTS BY GRADE SO ANY AND THEN SEVERE WHICH IS GRADE 3 OR 4 AND SO, WITH ANY SIDE EFFECT, CAN YOU ALSO GET A SENSE OF HOW BAD IT IS. SO WHILE ANEMIA WAS REALLY COMMON, GRADE 3 OR 4 ANEMIA WAS NOT VERY COMMON AT ALL AND I THINK THAT'S HELPS TO PUT SOME PERSPECTIVE ON SOMETIMES WHAT SOUNDS LIKE VERY SERIOUS PROBLEMS. BUT IN THE CASE OF NEWT ROUGH ATOM PENIA, YOU CAN SEE THATIA A COMMON SIDE EFFECT BUT IT IS IN FACT MUCH MORE OFTEN A SEVERE SIDE EFFECT. SO IN OUR WORK WITH THE DRUG BOXES IN TERMS OF HAVING A SYSTEMATIC METHOD FOR IDENTIFYING WHAT IS A KEY INFORMATION, WE BUILT ON THE GREAT ADVANCEMENT THAT FDA IN WHAT HAS CALLED THE HIGHLIGHT SECTION OF THE PRESCRIBING INFORMATION AND THIS IS FDA'S ATTEMPT WHERE THEY REALIZE THAT THE PRODUCT INFORMATION IS LONGER OR AS LONG AS MANY CONSENT FORMS AND SO THAT THE KEY INFORMATION NEEDED TO BE BROUGHT UP TO THE FRONT. SO WHAT WE USED IN TERMS OF THE SIDE EFFECTS THAT I SHOWED YOU WITH THIS ALGORITHM. SO THE MOST DANGEROUS SIDE EEIVETS ARE THE BLACK BOX WARNING, THE BOX WARNING SIDE OOIVETS, THE SERIES SIDE EFFECTS ARE THOSE THAT ARE IN THE WORNINGS AND PRECAUTIONS AND THE SYMPTOM SIDE EFFECTS ARE THOSE IN THE ADVERSE REACTION. AND THE THING THAT'S REALLY NICE HERE IS THAT THERE'S KIND OF AN EXTERNAL STANDARD THAT FDA HAS AGREED ON WHEN THEY EVENTUALLY APPROVE THE LABEL THAT THESE ARE THE MOST IMPORTANT THINGS TO BE HIGHLIGHTED TO PHYSICIANS FOR PRESCRIBING AND SIMILARLY IN THE PATIENT LABELING OR MEDICATION GUIDE, THESE ARE--THESE CORRESPOND TO THE HEADERS IN THE PATIENT INFORMATION. SO YOU COULD USE A SIMILAR APPROACH. IN TALKING ABOUT EXISTING RESOURCES, 1 OF THE RESOURCES THAT WE FOUND THAT WAS REALLY WONDERFUL WAS THAT IN NCI CANCER THERAPY EVALUATION FORM FOR INFORMATION, THAT THERE'S A WHOLE GLOSSARY WHERE THEY'VE DONE TREMENDOUS WORK FOR COMING UP CONSUMER NAMES FOR WHAT ARE OFTEN VERY DIFFICULT TO EXPLAIN SIDE EFFECTS AND I THINK 1 OF THE THINGS THAT MIGHT BE RECOMMENDED WOULD BE TO POINT PEOPLE TOWARDS RESOURCES LIKE THIS TO HAVE AN ECONOMIES OF SCALE SO THAT EVERYONE WHO WRITES AN INFORMED CONSENT REGARDLESS OF WHETHER IT'S FOR NCI OR NOT CAN USE THAT KIND OF LANGUAGE. SO OUR FINAL POINT WAS JUST THAT WE THINK THAT KEY INFORMATION FOR SIDE EFFECTS NEEDS TO REALLY BE ORGANIZED BY SERIOUSNESS, PROVIDE SEVERITY AND WHEN IT'S POSSIBLE, TO QUANTIFY. THANK YOU. >> THANK YOU VERY MUCH. QUESTIONS? >> HOLLY? >> I IT'S NOT A QUESTION, I THINK IT'S GREAT, I DON'T HAVE ANYTHING TO ADD. >> I THINK IT'S GREAT, TOO. I THINK 1 OF THE LESSONS THAT I'VE LEARNED FROM BOTH OF THESE PRESENTATION SYSTEM HOW CHALLENGING IT'S GOING TO BE TO DO THIS IN A PAGE IN A MEANINGFUL WAY AND PERHAPS, WELL WE CAN DISCUSS THAT MORE FURTHER. BUT THERE'S OBVIOUSLY A LOT OF INFORMATION HERE. SO ANY QUESTIONS OR COMMENTS FOR THE ENTIRE PANEL? WELL I THANK YOU 3 OF YOU FOR PARTICIPATING. THIS HAS BEEN VERY HELPFUL TO US. WE'RE JUST REALLY BEGINNING THIS AND I THINK THERE ARE A LOT OF IDEAS AND APPROACHES OUT THERE BUT YOU'VE BOTH, THE 3 OF YOU HAVE PROVIDED SOME VERY FASCINATING REALLY AND VALIDATED APPROACHES THAT I THINK WOULD PROBABLY NOT HAVE OCCURRED TO US OTHERWISE. SO THANK YOU ALL FOR YOUR CONTRIBUTIONS. WE'RE NOT ACTUALLY SCHEDULED FOR A BREAK FOR HALF AN HOUR BUT I THINK IT PROBABLY IS MOST APPROPRIATE TO TAKE 1 NOW. SO, WHY DON'T WE BREAK AND COME BACK AT 10:15. THANK YOU. DAVID FORESTER WILL DISCUSS THE SUBCOMMITTEE'S WORK ON THIS TOPIC. DAVID? >> OKAY, SO WHAT YOU HAVE IN FRONT OF YOU AND HOPEFULLY READ ON YOUR WAY IN IS THE COMMENTARY TO DATE ON THE NEW INFORMED CONSENT REQUIREMENTS AND I JUST WANTED TO FRAME THIS UP A BIT FOR OUR DISCUSSION. FIRST OF ALL THIS IS STILL VERY ROUGH, ALL RIGHT? WE'VE HAD NUMEROUS SUBCOMMITTEE PHONE CALLS AND A CONVENED MEETING TO DISCUSS THIS DRAFT RECOMMENDATION AND WE HAD A LOT OF DISPARATE VIEWS OF MEMBERSHIP ACROSS THE SUBCOMMITTEES AND IT'S BEEN A LOT OF WORK TO TRY TO HARMONIZE EVERYONE'S IDEAS AND KIND OF COME UP WITH A COMMON GROUPED. WE STILL HAVEN'T COMPLOATLY ACHIEVED THAT. SO YOU WILL SEE KIND OF DIFFERENT IDEAS HERE. A LOT OF OUR FRAMING HAD TO DO WITH WHETHER KEY INFORMATION IS A VERY SHORT LITTLE PRECISE PIECE OF INFORMATION THAT JUST INVITES SOMEONE TO DECIDE WHETHER TO REJECT IT RIGHT AWAY OR TO MOVE ON TO THE REST OF THE CONSENT, VERSUS AT THE OTHER END OF THE SPECTRUM WHETHER THE KEY INFORMATION COULD STAND ALONE AS, YOU KNOW AS BASICALLY ENOUGH INFORMATION FOR A SUBJECT TO DECIDE WHETHER OR NOT TO PARTICIPATE AND THE REST OF THE FORM WILL BE ANCILLARY ADDED DETAIL. I THINK IN THE END THE SUBCOMMITTEES CAME TO THE OPINION THAT IT'S SOMEWHERE IN THE MIDDLE OF THOSE 2 EXTREMES, BUT EXACTLY WHAT THAT LOOKS LIKE IS STILL VERY MUCH A CHALLENGE AND A DEBATE. AND I THOUGHT THE TALKS TODAY WERE WONDERFUL BUT ALSO HIGHLIGHTED THE AMOUNT OF WORK THIS IS GOING TO TAKE. THE OTHER THING I'VE NOTED AND I JUST MENTIONED TO JULIE A MINUTE AGO, WE DON'T HAVE PEOPLE WHO WRITE CONSENT FORMS INVOLVED YET AND WE THEED TO HAVE THEM INVOLVED. YOU KNOW WE HAVE IRBEXPZ SUBJECT ADVOCATES AND OTHERS INVOLVED BUT WE NEED PEOPLE WHO WRITE CONSENT FORMS INVOLVED IN THIS DISCUSSION, HOW ARE THEY GOING TO DO IT AND HOW WILL THEY GET THEIR GUIDANCE ABOUT HOW TO WRITE THESE. SO WITH THAT I THOUGHT I WOULD GO THROUGH AND JUST ALLOW COMMENTARYOT VARIOUS SECTIONS AND LET ALL OF YOU GIVE US YOUR INPUT, MENTION WHERE YOU WANT TO CHANGE THINGS, WE DON'T HAVE TO GET THE RIGHT LANGUAGE TODAY. LET'S NOT GET TOO DEEP IN THE COMMAS, BUT CERTAINLY I WOULD LIKE TO TAKE NOTES SAYING WE SHOULD MOVE THIS WAY, WE SHOULD MOVE THAT WAY, YOU'VE MISSED THIS ENTIRE AREA. SO WITH THAT STEPHEN ANY COMMENTS FOR OPENING? >> NO, I'M HOPING SO I THINK IN SOME AREAS WE'RE UNLIKELY TO EVEN GET THAT FAR. I MEAN I THINK SOME OF THE THINGS WE HEARD THIS MORNING ARE ARE THINGS WE WEREN'T REALLY THINKING ABOUT. SO I'M NOT SURE HOW MUCH OF THE DRAFT THAT WE'RE LOOKING AT WILL ACTUALLY SURVIVE. I THINK WE WILL PROBABLY NEED A DISCUSSION OF STRATEGIC DIRECTIONS AFTER THIS. BUT LET'S SEE WHAT WE CAN DO. OKAY, SO THE BEGINNING OF THIS, WE REALLY JUST GAVE THE FIRST PAGE AND HALF ARE REALLY THE BACKGROUND FELT QUESTIONS THAT WERE PROVIDED TO US BY OHRP ON BEHALF OF THE AGENCIES. YOU WILL NOTE HERE THAT IT STARTS ON LINE 16 WITH THE DEFINITION OF CLINICAL TRIAL. THAT WAS AT OHRPs REQUEST TO THE SUBCOMMITTEES AND THEN AN EMPHASIS, YOU KNOW AS JERRY MENTIONED THIS MORNING, WORK ON CLINICAL TRIALS RIGHT NOW, DON'T WORRY ABOUT SOCIAL BEHAVIORIAL THINGS, SO THAT'S 1 OF THE POINTS WE ADDED IT AND IT'S IMPORTANT TO REMEMBER. THEN THEY GAVE THE BACKGROUND FOR MEN AND WOMEN--WHAT THE LANGUAGE 116 FOR REQUIREMENTS FOR KEY INFORMATION AND UNDERSTANDABLE AND ORGANIZED AND PRESENTED IN A WAY THAT DOESN'T PROVIDE A LIST OF ISOLATED FACTS, ET CETERA. AND THEN WE HAVE THE PREAMBLE LANGUAGE WHERE YOU KNOW THE AGENCY SUGGESTED THAT PERHAPS THESE 5 ITEMS COULD SERVE AS THE KEY INFORMATION. I THINK AN INTERESTING EFFECT OF HAVING THIS HERE IS THAT FROM A COMPLIANCE PERSPECTIVE, I THINK A LOT OF IRB CHAIRS AND OTHERS MIGHT SAY, YOU KNOW WHAT? I HAVE A SAFE HARBOR. IF I USE THOSE 5 PREAMBLE ELEMENTS FOR MY KEY INFORMATION, I CANNOT BE FOUND OUT OF COMPLIANCE BY A GOVERNMENT AGENCY. SO THERE IS THAT EFFECT OF HAVING THIS LISTED. HOWEVER IF YOU LOOK AT THE REST OF THE PREAMBLE LANGUAGE AROUND THIS, YOU KNOW THEY VERY MUCH DID SAY, THAT THIS IS A--THIS A POSSIBLE LIST AND THEY'R OPEN TO INTERPRETATION. AND SO WE DO HAVE LATITUDE TO SAY THAT THESE ARE NOT THE RIGHT ELEMENTS. BUT IT IS THERE IN THE PREAMBLE. OKAY, SO THEN THE OTHER QUESTION WE ASKED AT THE SUBEXITEE LEVEL IS WHETHER WE ANSWER THE OTHER 6 QUESTIONS BY OHR AND THE OTHER AGENCIES AND THE FEEDBACK IS THAT YES A LOT OF WORK WENT INTO THOSE 6 QUESTIONS, PLEASE ANSWER. SO WE HAVE FRAMED IT THAT WAY AND ALTHOUGH YOU WILL NOTICE WHEN WE GET TO QUESTION 1, WE SAID SEE QUESTION 3/4, OTHER THAN THAT WE FOLLOWED THE FORMAT OF THE 6 QUESTIONS. BUT THEN WE DID FIND THERE WERE CERTAIN ISSUES THAT TRANSCENDED ALL 6 QUESTIONS AND THAT'S THIS BEGINNING PART. AND SO, YOU KNOW RIGHT NOW THEY'RE JUST CALLED NUMBER BECAUSE I DON'T KNOW WHAT ORDER THAT WILL I END UP IN, BUT THE IDEA BEHIND THESE POINTS HERE AT THE BEGINNING OF THE DOCUMENT IS THAT THESE ARE GENERAL ISSUES THAT APPLY TO THE KEY INFORMATION AND TRANSCEND THOSE QUESTIONS. SO THE FIRST 1 THERE STARTING TO LINE 61, WE JUST NOTED THAT THE DEFINITION OF A CLINICAL TRIAL WAS ENCLUEDED AND SACHRP WAS ASKED TO FOCUS ON THIS, TO MAKE SURE WE WERE NOT GETTING SOCIAL, BEHAVIORIAL, THIS WAS INTENTIONAL. OKAY. NEXT POINT, STARTING WITH LINE 65 IS THAT WE WANT TO EMPHASIZE THAT THE GOAL OF THIS IS PROVIDING SUBJECTS WITH INFORMATION THAT WILL HELP THEM DECIDE WHETHER OR NOT TO PARTICIPATE AND THAT WE NEED TO FOCUS ON THE SUBJECTS UNDERSTANDING AND VIEW POINT. NO MATTER WHAT APPROACH WE END UP RECOMMENDING, IT HAS TO RELY ON A BASE OF SUBJECTS UNDERSTANDING, WHAT'S BEST FOR THISEM IN THIS PROCESS. --FOR THEM IN THIS PROCESS. AND THEREFORE WE ADDED THAT WE BELIEVE THAT PATIENTS, PRACTITIONERS RESEARCH POPULATIONS SHOULD BE UTILIZED IN THE DEVELOPMENT OF THE CONSENT FORMS AND PROCESSES. SO I WOULD LIKE TO ASK FOR COMMENTS ON THE 65-70. LESLIE? >> SO I CERTAINLY AGREE WITH THIS. THERE'S--THE PART THAT KIND OF BROTHERS ME AND IT UNDERLINES SOME OF THE DISCUSSION MORE GENERALLY IS OF COURSE, WE SHOULD BE THINKING ABOUT SUBJECTS UNDERSTANDING BUT WOULD WE BE DOING THAT IN CONSENT GENERALLY? SO IT'S NOT--THEN OF COURSE, THE PROVISION ABOUT KEY INFORMATION IS PHRASED IN TERMS OF BEING HELPFUL AND I DON'T HAVE A SUGGESTION, BUT YOU KNOW WHETHER IT'S IMPORTANT TO RECOGNIZE THIS IS ALWAYS OUR GUIDING LIGHT JUST BY THE FACT THAT WE DON'T NECESSARY--WE MAY NOT FOLLOW IT IN A LOT OF TEMP PLATES THAT WE DO THAT PERHAPS PARTICULARLY BECAUSE OF WHAT THE GOAL OF THIS IS, THAT WE ARE, YOU KNOW, AND I THINK ABSOLUTELY THAT GETTING THE INPUT AND WHAT WE'VE ALREADY GOTTEN THIS MORNING IS INCREDIBLY HELPFUL SO I DON'T DISAGREE WITH THE STATEMENT BUT I HAVE TO EXPRESS MY CONCERN THAT WE'RE SUGGESTING THAT OTHERWISE WE'RE NOT PAYING ATTENTION TO PATIENTS OR PARTICIPANTS UNDERSTANDING. AND THE REASON YOU WRITE BACK AND REVIEW THEM, THEY OFTEN HAVE THINGS LIKE LEGAL LIABILITY AND MAKING SURE WE JOIN THE FACTS. >> I KNOW AND I SAY THAT AS A LAWYER WHO SAT ON AN IRB AND LET'S REMEMBER WHAT THE GOAL IS AND I KNOW ABSOLUTELY THAT'S KREBS CYCLE WE HAVE OUR 30 PAGE CONSENT FORMS AND WHY WE ARE TRYING TO ADDRESS THIS. >> JONATHAN? >> I THINK IT'S ALSO IMPORTANT TO POINT OUT IN THIS PORTION OF THE DOCUMENT, ALSO, BECAUSE IT'S NOT JUST FOCUSING ON SUBJECTS UNDERSTANDING BUT FOCUSING ON WHAT THE POTENTIAL PARTICIPANT WOULD THINK IS THE KEY INFORMATION WHICH I THINK WILL BE VERY DIFFERENT THAN WHAT OR MAY BE VERY DIFFERENT THAN WHAT IRB OR THE INVESTIGATOR THINKS IS KEY. >> OKAY, SO I'M JUST NOT GOING IT CHANGE THIS. YES? >> I'M NOT SURE IF THIS BELONGS ELABORATED HERE BUT 1 OF THE THINGS THAT SEEMS LIKE IT WOULD BE VERY POSSIBLE TO DO WOULD BE TO GATHER MORE INFORMATION ABOUT WHAT SUBJECTS THINK IS KEY INFORMATION AS PART OF THE DEBRIEFING, EXIT INTERVIEW PROCESS FOR A TRIAL THAT'S ONGOING. IT SEEMS LIKE NOT EVERY INVESTIGATOR WOULD BE ABLE TO DO THAT BUT IT WOULD BE VERY EASY TO JUST MAKE A SUGGESTION. YOU KNOW HERE ARE SOME WAYS THAT YOU COULD LEARN ABOUT WHAT WAS KEY IN THIS STUDY THAT OTHER PEOPLE COULD LEARN FROM. >> I THINK WE COVER THAT IN THE NEXT PARAGRAPH, LINE 73-78 WHERE WE SHOULD DO IMPERICAL RESEARCH, ET CETERA? >> YEAH. SPECIFICALLY HAVING TO DO WITH SAY, SOMEBODY JUST COMING OFF A CONSENT FORM LIKE THE [INDISCERNIBLE] >> DAVID I DON'T KNOW IF THIS WOULD ADDRESS LESLIE'S POINT OR NOT, BUT MAYBE IF WE AGREE THAT THE FOCUS ON THE SUBJECTS UNDERSTANDING AND VIEW POINT SHOULD UNDERLAY THE APPROACH BECAUSE AGAIN, THAT'S CERTAINLY THE UNDERSTANDING IS SOMETHING WE SHOULD BE DOING IN ALL PARTS OF THE CONCEPT FORM. BUT SUBJECT'S DECISION MAKING. >> DECISION MAKING AND VIEW POINT? >> OR JUST DECISION MAKING. >> OH. >> I DON'T KNOW IF THAT--THE WAY IT STANDS IS NOT WRONG, IT JUST--RAISES THE QUESTION OF WHY AREN'T WE DOING THIS ALREADY? I DON'T KNOW. >> SANDRA? >> YOU'RE NOT TRYING TO SUGGIEST HERE THAT PEOPLE SHOULD DELAY DOING ANYTHING HERE UNTIL MORE RERESEARCH IS DONE, ARE YOU? >> NO. >> AND YOUR LANGUAGE AND REASONABLE LEAP CLEAR ON THAT. I--REASONABLY CLEAR ON THAT. I WANT TO MAKE SURE WE DON'T KNOW ENOUGH ABOUT HOW TO DO THIS IN ORDER TO START. I THINK WE DO. >> WE NEED TO START AND STUDY AT THE SAME TIME. MAKE IT BETTER. OKAY, ANY FURTHER QUESTIONS ON 65-70? OKAY. 72-77 IS THIS IDEA WE SHOULD DO RESEARCH, ANY COMMENTS ON THAT? >> OKAY, STARTING ON LINE 79 AND THIS IS 1 OF THOSE FRANKEN STEIN PARAGRAPHS THAT CAME OUT OF THE SUBCOMMITTEE PROCESS WAS I STARTED WITH THIS IDEA OF WHAT IS THE SPECTRUM UPON WHICH KEY INFORMATION CAN SIT? AND THE SPECTRUM WE DEBATED MOST WAS THIS VERY SHORT INTRODUCTION THAT PROVIDES AN INITIAL STEP VERSUS SOMETHING THAT STANDS BY ITSELF WITH ENOUGH INFORMATION TO GET CONSENT. SO THIS PARAGRAPH IS A VERY WORKED OVER ATTEMPT TO SAY WE THINK WE SHOULD BE IN THE MIDDLE OF THAT SPECTRUM. SO I GUESS I WOULD ASK ALL OF YOU, DID WE ACHIEVE THAT IS IS IT EVEN A POINT WORTH MAKING IN THIS DOCUMENT? >> I THINK SINCE WE DON'T HAVE AN ANSWER, THAT IT IS A POINT WORTH MAKING. OR AT LEAST SOMETHING TO LEAVE IN FOR NOW UNTIL WE COME TO SOMETHING MORE SPECIFIC. >> YEAH. >> I GUESS I WOULD SAY THOUGH IN THE CONTEXT OF WHAT JERRY'S SORT OF FRAMING OF THIS IN THE BEGINNING, I'M NOT SURE THAT THE FIRST POINT THERE ACTUALLY IS SOMETHING THAT IS AN OPTION, RIGHT? THAT THE KEY INFORMATION COULD BE VIEW AS NO MORE THAN A FIRST STEP. I THINK IT'S--MY UNDERSTANDING WOULD BE THAT IT IS MEANT TO PROVIDE MORE THAN JUST--DO YOU WANT TO READ THE NEXT PAGE? SO, ALTHOUGH MAYBE THAT'S NOT SPELLED OUT LITERALLY IN THE REGULATORY LANGUAGE, BUT-- >> WELL, AND I THINK THE REASON--THE REASON IT CAUGHT ME IS SOME VERY SMART, WELL-EXPERIENCED IRB PEOPLE ON THE SUBCOMMITTEES TOOK THAT APPROACH, THEY ARGUED STRONGLY AND FELT DEFEATED IN THE END. >> WELL AND YOU'RE SORT OF CAUGHT BECAUSE THE OTHER ALTERNATIVE, YOU KNOW IT HAS TO BE SOMEWHERE ON THAT SPECTRUM AND WE SHOULDN'T EMBRACE EITHER EXTREME. BUT THE NATURAL CONSEQUENCE OF SAYING IS DECISIONS IS THAT YOU DON'T NEED TO READ THE REST BECAUSE NOW IT WILL HAVE INFORMATION THAT'S IMPORTANT AND RELEVANT. SO IT'S A LITTLE BIT--I ACTUALLY LIKE THE IDEA OF THE SPECTRUM BECAUSE IT REALLY PRETTY STRONGLY IMPLIES YOU ARE NOT GOING TO CHOOSE 1 OF THE ENDS. BUT THE IMPLICATIONS ARE TROUBLING OF EITHER EXTREME. >> OKAY? ALL RIGHT, THE NEXT 191-100 WAS A POINT WE DISCUSSED A LOT, THE DEBATE WAS IS THIS GOING TO SHORTEN CONSENT FORMS? SO WE KIND OF KEPT GOING BACK TO THAT AND FINALLY WE CAME UP WITH THIS STATEMENT HERE THAT THESE ARE ADDITIVE REQUIREMENTS. NO 1 PREVIOUSLY EXISTING IN THE CURRENT RULE WERE REMOVED. RIGHT? WE ADDED REQUIREMENTS TO THE EXISTING REQUIREMENTS. THEREFORE, IT IS VERY UNLIKELY THAT USING THIS KEY INFORMATION AS A TOOL WILL LEAD TO SHORTER CONSENT FORMS. IT WILL PROBABLY LEAD TO CONSENT FORMS THAT ARE AS LONG, PERHAPS LONGER, BUT THAT IF WE DO THIS CORRECTLY, THEY WILL BE MORE UNDERSTANDABLE TO SUBJECTS. THE PROCESS WILL BE BETTER FOR SUBJECTS. SO THAT WAS THE INTENT OF 91 TO 100. LET'S JUST KIND OF CLARIFY THAT. >> THIS FEELS LIKE A REAL ESTATE QUESTION. LIKE THIS IS TERRITORY THAT YOU DON'T WANT TO GIVE UP. LIKE YOU'RE MARRIED TO THIS LONGER CONSENT. I MEAN I'M NOT JUST TRYING TO SAY THAT HAD IS NECESSARILY FASHIONED ON SHORTEN THE CONSENT BUT WHAT IF IN THIS PROCESS, YOU KNOW YOU END UP, YOU KNOW GAINING SOME CLARITY, GETTING A REAL YOU KNOW HANDLE ON WHAT PARTICIPANTS WANT AND YOU LOSE A FEW PAGES? >> SO I MEAN WE TALK TO SUBCOMMITTEES REALLY WRESTLED WITH THIS AND THERE WAS A SPECTRUM--NO. SO THERE WERE--AND WE DISCUSSED IT EXPLICITLY IN SECTION 6 BUT I WILL GIVE YOU MY OPINION WHICH THAT I THINK LENGTH BY ITSELF IS NOT MEANINGFUL. YOU KNOW THIS IS ALL ABOUT UNDERSTANDABILITY AND UNDER NO--NOT EVERYBODY AGREED WITH THIS. BUT I JUST WOULDN'T HAVE THIS CONCERN. WE'RE ADDING SOMETHING THAT'S SUPPOSED TO BE A DECISION TOOL AND IF IT'S AN EXTRA COUPLE OF PAGES AT THE BEGINNING OR 3 PAGES AT THE BEGINNING IF IT ADDS TO THE UNDERSTANDABILITY OF THE CONSENT, THAT LENGTH IS A SURROGATE FOR UNDERSTANDABILITY AND IF WE INCREASE THE UNDERSTANDABILITY I DON'T THINK IT MATTER FIST WE MAKE IT LONGER. SMRKS AND THIS REALLY CAME ABOUT EARLY AS SOME OF THE MEMBERS SAID WE'RE SHORTENING THE CONSENT, KIND OF GAVE UP. >> WELL I THINK DIANEA'S POINT WAS REALLY WHAT IF THE KEY INFORMATION ACTUALLY MOTIVATES BETTER CLARITY IN THE REST OF THE CONSENT FORM. BECAUSE WHAT WE DON'T WANT IS TO GIVE DIRECTIONS ON HOW TO DO THIS BEAUTIFUL KEY INFORMATION THING AND THEN JUST PLOP 25 PAGES OF BULLETED UNSTRUCTURED LISTS ON AFTER IT. WHAT WE WOULD REALLY LIKE WOULD BE TO SEE THAT THAT THINKING ABOUT KEY INFORMATION ACTUALLY HELPS CLARITY AND THAT MIGHT ACTUALLY END UP WITH--I MEAN I AGREE WITH YOU STEPHEN THAT THE LEPGHT IS NOT THE KEY THING BUT THE IDEA WOULD BE THAT KEY INFORMATION SHOULD INFLUENCE HOW CONSENT FORM WRITERS THINK ABOUT THE REST OF THE FORM. >> THANK YOU NANCY FOR BEING MY TRANSLATOR. >> [LAUGHTER] >> THANK YOU, JERRY. I THINK SOME OF THE THINGS WE SAW THIS MORNING ARE EQUALLY APPLICABLE TO THE CONSENT FORM AND APPLICATION, WE HAVE TO LEARN THOSE LESSONS. I HAVE TO SAY WE TALKED ABOUT LEJT FR AS LONG AS I CAN REMEMBER AND THEY KEEP GETTING LONGER. SO THAT IN A WAY I SEE THIS SORT OF TAKING A STEP BACK FOR THE MOTIVATION FOR THE NEW REQUIREMENT IS GIVING UP IN A WAY OF TRYING TO SIMPLIFY AND MAKE SENSE AS THEY STAND BETTER SAYING THERE ARE GOING TO BE THESE DRIVERS WHETHER THEY'RE LIABILITY CONCERNS OR OTHER THINGS OR COMPLIANCE CONCERNS THAT HAVE STOOD IN THE WAY OF US MAKING BETTER MORE STREAMLINED CONSENTS IN THE FIRST PLACE. SO NOW WE'RE GOING TO TAKE--PUT ALL OF THOSE THINGS ASIDE AND BUILD A TOOL THAT WILL BE PART OF THE CONSENT PROCESS THAT WILL BE FOCUSED EXPLICITLY AND ONLY ON PATIENT--ON PARTICIPANT DECISION MAKING. IF THERE ARE SIDE EFFECTS THAT IMPROVE THE REST THAT'S GREAT, BUT WE'VE BEEN TRYING TO DO THAT FOR AN AWFULLY LONG TIME WITHOUT SUCCESS. >> SO IT DOES OCCUR TO ME FROM YOUR COMMENTS, 1 THINK THIS WE COULD DO HERE IS ADD A STATEMENT ABOUT 1 OF THE REQUIREMENTS OF THE NEW ELEMENTST CONSENT THAT THE WHOLE CONSENT FORM BE PRESENTED IN A WAY THAT'S CLEAR. SO MAYBE WE COULD ADD THAT AS A CLARIFIER? >> SANDRA? >> TO ME THE QUESTION OF WHETHER LENGTH IS A BARRIER TO COMPREHENSION IS AN IMPERICAL YE AND I WOULDN'T BE SURPRISED TO FACT BEING PRESENTED WITH AN EXTREMELY LONG CONSENT FORM CONTAINS A MESSAGE OF ITS OWN THAT POTENTIALLY GETS IN THE WAY OF UNDERSTANDING AND THE APPRECIATION OF CONSENT PROCESS. SO I WOULD--I WOULDN'T ACCEPT THAT AS A GIVEN THAT IT'S NOT--IT'S NOT A BARRIER, I THINK WE CAN FIND OUT WHETHER IT'S A BARRIER. >> SO--[INDISCERNIBLE] >> I WILL ACTUALLY ANSWER SANDY'S QUESTION BECAUSE THERE IS I RESEARCH ON THAT. --THERE IS RESEARCH ON THAT. PEOPLE MAY BE MORE FAMILIAR WITH THIS THAN ME, THE STUDY THAT COMES TO MINE IS KRISTIN'S GRADING STUDY, AND AGAIN IT WAS A FAKE TRIAL SO NONE OF THESE THINGS IN THE REAL WORLD BUT EVERYBODY THOUGHT THE CONSENT THEY GOT WAS THE IDEAL WAY. SO IT WAS DISCOURAGING. I MEAN--IT WAS DISCOURAGING. >> NO, I THINK THEY DID--IT WAS A REAL STUDY AND THEY THINK IT DID NOT MEANINGFULLY CHANGE THEIR COMPREHENSION AND SO, THE STUDY WAS INTERPRETED IN DIFFERENT WAYS, RIGHT? PEOPLE WHO WANT SHORT STORM SAID LOOK SHORT FORMS WORK JUST AS WELL AS LONG FORMS AND PEOPLE WHO SAY LENGTH MATTERS, THEY SAY LOOK, LONG FERMS ARE FINE TOO. BUT I DO THINK THERE IS DATA ON THIS. >> CAN I MAKE 1 COMMENT ALSO ABOUT THIS THAT IS JUST NOT PART OF WHAT YOU'RE GOING THROUGH? I THINK IT WOULD BE REALLY IMPORTANT IN THE TITLING AND IN THE WAY WE PRESENT IT TO REALLY MAKE IT VALID AND VERY CLEAR THAT THIS DOES NOT APPLY TO SOCIAL AND BEHAVIORIAL RESEARCH AT THIS TIME. BECAUSE YOU SAID IT AT THE TIME, I THINK MAKING IT CLEAR IN THE WAY IT'S PRESENTED AND TITLED WOULD BE HELPFUL. >> RECORDING: WELCOME TO WEBEX, ENTER YOUR ACCESS OR CODE OR MEDING NUMBER. [BEEPING ] >> ACTUAL LOAMACY I THINK--ACTUALLY I THINK CHRISTINE'S IS A CAUTIONARY TALE INSOFAR AS WE MAKE THE EFFORT, WHY TRY TO IMPROVE CONSENT FORMS BY THINGS THAT SORT OF MAKE SENSE TO US LIKE SHORTENING AND IT TURNS OUT WHEN WE MAKE THE EFFORT TO IMPERICALLY TEST THOSE, THEY'RE NOT NECESSARILY RECEIVED THE SAME WAY WE EXPECT THEM TO BE BY POTENTIAL PARTICIPANTS. SO I THINK THAT APPLIES TO ALL OF THE THINGS WE'RE TALKING ABOUT. THE MORE WE CAN DO BASED ON THE STUDIES LIKE THOSE WE HEARD ABOUT THIS MORNING, THE BETTER. >> YOU KNOW I DON'T THINK WE CAN FOCUS ON LENGTH, YOU KNOW, WITH THE ACCEPTION OF ALL THESE OTHER VARIABLES THAT ARE INFORMED CONSENT AND COMP REHENGSZ AND READABILITY AND OTHER ELEMENTS THAT ARE INCLUDED I DON'T THINK IT'S JUST ABOUT LENGTH. >> OKAY. >> ALL RIGHT. >> ALL RIGHT. ANYMORE COMMENTS ON THIS LENGTH PARAGRAPH? NEED OTHER CHANGES? WE WILL ADD SOMETHING ABOUT THE WHOLE CONSENT FORM TO BE ORGANIZED AND ENHANCING UNDERSTANDING. >> YOU KNOW, I'M TRYING TO REMEMBER, ON THE GRADEY PAPER WASN'T THERE ANOTHER FINDING THAT REALLY WHAT MATTERED IS THE LENGTH OF DISCUSSION, TIME FRAME OF DISCUSSION OR WAS THAT A DEFINITE STUDY? I THOUGHT THAT WAS IT. ANYWAYS. OKAY. OKAY, MOVING ON THEN TO 103-106. HERE IT'S A TOPIC WE KEPT GOING BACK TO WAS, WE DON'T KNOW HOW TO MAKE THIS SCALABLE AND CONSISTENT. WE DON'T KNOW HOW TO MAKE IT SO THAT DIFFERENT IRBs LOOKING AT THE SAME STUDY COME UP WITH SIMILAR KEY INFORMATION STORIES. OR PEOPLE WRITING CONSENT STORIES COME UP WITH DIFFERENT KEY INFORMATION STATEMENTS AND SO WE JUST KIND OF PUT THAT DOWN AS, YOU KNOW WE THINK THIS IS A CONCERN. WE ALSO THINK FLEXIBILITY IS GOOD, SO NOTED IS HOW IT ENDED UP. >> SO I WOULD JUST NOTE SOMETHING THAT'S IMPLICIT IN QUESTION 1 WHICH IS THAT IT'S NOT SIMPLY DIFFERENT INTERPRETATION OF THE DIFFERENT RIERPTS BUT THE FACT THAT DIFFERENT KEY INFORMATION MAY BE GREATLY DIFFERENT IN DIFFERENT STUDY DESIGNS, WE TEND TO TALK LARGELY ABOUT CANCER TRIALS BECAUSE THEY'RE SORT OF 1 EXTREME THAT HIGHLIGHT MANY OF THE ISSUES THAT WE SEE IN PARTICULARLY, RISKS. BUT AN IRB SEEING THINGS REALLY ACROSS THE SPECTRUM AND MANY OF THE THINGS THAT WOULD BE KEY INFORMATION TO SOMEONE FACING A LETHAL DISEASE ARE SIMPLY NOT SO FOR AN ACNE TRIAL. SO I THINK THERE IS VARIABILITY, THIS IS GOING TO BE A REAL CHALLENGE IN DEVELOPING COMPLIANCE ORIENTED GUIDELINES. >> ALL RIGHT. HEARING NO OBJECTIONS TO THE LANGUAGE AS IS, ALL RIGHT, THEN 108 IS SOMETHING AGAIN, WE RETURN IT A LOT IN OUR DISCUSSIONS. IT'S JUST THE FACT,--AND THIS IS TRUE NOW AS IT WILL BE TRUE WHEN WE ARE USING KEY INFORMATION--THAT SUBJECTS HAVE REALLY VARIED BACKGROUND. I MEAN, YOU KNOW THE INCLUSION, EXCLUSION CRITERIA, NARROW THEM IN SOME WAYS MEDICALLY BUT PEOPLE COME TO RESEARCH STUDIES WITH DIFFERENT MEDICAL BACKGROUNDS. WITH DIFFERENT VALUES. SOME OF THEM ARE ALTRUISTIC AND SOME OF THEM ARE NOT ALTRUISTIC, THEY'RE LOOKING FOR THE BEST DEAL FOR THEMSELVES, ET CETERA. SO WE HAVE THIS PROBLEM OF TRYING TO COME UP WITH THIS KEY INFORMATION AND SO BY DEFAULT WE END UP GOING FOR A REASONABLE PERSON. THE REASONABLE SUBJECT. BECAUSE WE CANNOT PREDICT OR ACCOUNT FOR ALL THE POSSIBLE TYPES OF PEOPLE THAT MAY PRESENT AND BE OFFERED A CHANCE TO LOOK AT THIS CONSENT. NANCY? >> SO THIS IS SOMETHING THAT MAY COME UP AGAIN WHEN WE GET TO THE QUESTION THAT HAS ALL THE LIST OF TOOLS IN IT WHERE YOU'VE GOT THE FRAMING TOOL LISTED THAT I THINK IS--ISN'T ACTUALLY A TOOL. BUT 1 OF THE THINGS THAT--AND MAYBE IT BELONGS IN THIS BEGINNING SECTION, THAT WE SHOULD PROBABLY TALK ABOUT IS SOME KIND OF STATEMENT THAT FRAMES THE DECISIONS VERY SPECIFICALLY IN COMPARISON AND CONTRAST TO CLINICAL DECISION MAKING THAT PUTS MORE EMPHASIS ON SOME OF THE ISSUES THAT, YOU KNOW AND I WOULDN'T WANT IT TO BECOME BOILER PLATE BUT IT MAY BE MORE STANDARDIZABLE THAN SPECIFIC DISCLOSURES IN KEY INFORMATION AND 1 OF THOSE THINGS WOULD BE SOMETHING LIKE, YOU KNOW WE'RE TRYING TO COMUP WITH EVERYTHING THAT WE THINK THAT SUBJECTS NEED TO KNOW AND WOULD MOST WANT TO KNOW IN MAKING THEIR DECISION BUT WE KNOW THAT EVERYBODY'S DIFFERENT SO PLEASE BE SURE THAT YOU READ THE WHOLE CONSENT FORM BECAUSE THERE MAY BE SOMETHING THAT'S ESPECIALLY SIGNIFICANT TO YOU THAT WE HAVEN'T LISTED UP FRONT. YOU KNOW SOMETHING LIKE THAT. THERE ARE SOME KEY THINGS THAT SHOULD BE SAID TO FRAME TAYLORED KEY INFORMATION. >> SO I DON'T WANT TO QUIBBLE WITH WORDS WITH A DOCUMENT IN DRAFT BUT I AM GOING TO DO THAT AND THAT IS ON LINE 109, KEY INFORMATION THAT WILL GIVE POTENTIAL SUBJECT THAT WILL FIND DISPOSITIVE IN DECIDING WHETHER OR NOT TO PARTICIPATE AND I QUIBBLE WITH THAT BECAUSE I DON'T KNOW THAT WE'VE AGREED THAT THAT'S WHAT THIS IS SUPPOSED TO BE AND THE REGULATORY LANGUAGE IS ABOUT ASSISTING AND WHAT WOULD BE HELPFUL IN MAKING THAT DECISION. AND SO, I THINK THAT IS ACTUALLY AN IMPORTANT QUIBBLE ON A WORD. >> HELPFUL. >> HELPFUL MAKES IT MUCH BETTER. THANK YOU. >> ALL RIGHT. YEAH, LOOKS LIKE SOME LAWYER WAS WRITING IT. [LAUGHTER] >> FOLLOWING MY PRIOR COMMENT IN THE 103 TO 106, COULD WE ADD AS A PRACTICAL ADMINISTRATIVE AND LOGISTICAL ISSUE AND REFLECTING VARIABILITY AND TRIAL DESIGN, WE'RE CONCERNED WITH THE--I MEAN I'M JUST--I THINK IT'S NOT SIMPLY PRACTICAL, ADMINISTRATIVE AND LOGISTIC, THERE ARE MUCH MORE SUBSTANTIVE REASONS WHY THERE WILL BE GREAT VARIABILITY. >> YOU HAVE LANGUAGE? >> RATHER THAN LOGISTICAL REVIEW IN REFLECTING VARIABILITY OF TRIAL DESIGN AND GOALS. I'LL GO BACK. IT'S STILL DRAFT. WE WILL NOT APPROVE IT TODAY. THIS WILL GET MANY MORE COMB OVERS. >> I THINK FOR 108, I DON'T HAVE SUGGESTED LANGUAGE. I WANT TO OBSERVE THAT THE TOOL WE SAW THIS MORNING, THE OPTION GRID, WHICH HAD, YOU KNOW FOR ATRIOLE FIB ROUGH ATOMALATION TOOK INTO ACCOUNT THE PATIENT DEMOGRAPHICS IN SETTING UP THE OPTIONS. WAS BOTH ILLUSTRATIVE AND FRUSTRATING BECAUSE WE WILL NOT HAVE ACCESS TO THAT IN THE SETTING OF A SINGLE CONSENT FORM BUT IT SUGGESTS THAT YOU KNOW THOSE DIFFERENCES MAY HAVE A REAL IMPACT IN WHAT'S RELEVANT TO A PARTICULAR PATIENT, PARTICIPANT. >> TO COMMENT IS ON THAT AND WHAT IS ON THE SCREEN, THAT THE RISKS MATTER SO MUCH SO THAT IF YOU DON'T HAVE THE TECH IN IICAL ABILITY TO APPLY FOR THE NUMBERS FOR THAT PATIENT YOU WILL BY NECESSITY NEED TO GOVERN A GENERAL DESCRIPTIVE CONCEPT AND NOT GIVE NUMBERS IF YOU WERE TO GIVE NUMBERS FOR AN AVERAGE FOR THE POPULATION, IT WOULD BE WRONG FOR MOST PATIENTS AND WE STRUGGLE TRYING TO COME UP WITH A SIMPLE FORM AND USE NUMBERS AND DECIDED NOT TO FOR THAT 1 SPECIFIC--FOR MANY OTHER TOPICS IN WHAT WE PRESENTED, WE DO NOT HAVE THAT LEVEL OF COMPLEXITY. I JUST HAPPEN TO SHOW THE MOST COMPLEX 1 SO THAT'S NOT AN EXAMPLE OF WHAT IT WILL BE LIKE MOST OF THE TIME. BUT DO YOU HAVE TO ACCOUNT FOR--THERE ARE SWAIGDZS WHERE GIVING NUMBERS--SITUATIONS WHERE GIVING NUMBERS BY EXAMPLE THAT WOULD NOT BE COMMON, AVERAGE DOESN'T REALLY APPLY WELL, YOU WANT TO AVOID GIVING EXAMPLE NUMBERS AND PEOPLE HOLD ON TO THOSE EXAMPLES AS WHAT WILL HAPPEN TO THEM. THE OTHER COMMENT IS ON, I GUESS LINE 115, ALL SUBJECTS SHOULD READ THE ENTIRE CONSENT. THIS GOES BACK TO THAT, WHERE ARE YOU FROM 1 END TO THE OTHER END OF THE SPECTRUM. IT'S POSSIBLE IN THE PROCESS OF INFORMED CONSENT, THERE MAY BE A REASON YOU WANT TO GIVE SUPPLEMENTAL INFORMATION IF THE READER WANTS IT. IF YOU HAVE, YOU KNOW 16 PAGES, 30 PAGES, WHATEVER IT IS AND THEN ARE SAYING YOU SHOULD READ THIS ENTIRE THING, YOU DON'T HAVE THE WHAT IS SUPPLEMENTAL? SO WHAT IS THE KEY INFORMATION IS WHAT IS YOU SHOULD READ AND THE REST OF IT IS IF YOU WANT OR THERE'S SOME LARGER AMOUNT OF INFORMATION YOU SHOULD READ BECAUSE YOU NEED DEEPER INFORMATION, THAT SEEMS LIKE THE BILL CHALLENGE HERE, IS HOW MUCH IS REALLY REQUIRED OR ESSENTIALLY EMPHASIZED TO MEET WHAT YOU NEED TO KNOW WHEN CHOOSING TO CONSENT AND HOW MUCH IS SOMETHING SUPPLEMENTAL FOR FURTHER DISCUSSION TO BE ABLE TO BE THERE IF THAT PARTICIPANT WANTS IT. >> YOU KNOW WHAT THATRY MINDS ME OF AND WE USED TO--I HAVEN'T SEEN THIS QUESTION LATELY AT THE IRB, WE FROM TIME TO TIME WOULD GET A REQUEST FROM A SUBJECT AND SAY, I WANT THE PROTOCOL. WELL THANK YOU FOR THE CONSENT FORM BUT I WOULD LIKE A PROTOCOL, TOO, I HAVE A Ph.D. I CAN FIGURE IT OUT AND A LOT OF SITES WOULD SAY, NO, YOU CAN'T HAVE IT OR THE SPONSOR WOULD SAY NO, YOU THAT'S CONFIDENTIAL, DON'T GIVE IT TO THEM. AND SO WOE WOULD HAVE THE DEBATE AND GENERALLY THE IRB SAID YEAH, IF THE SPONSOR WILL RELEASE IT IF IT'S A PRIVATELY HELD COMPANY, AS OPPOSE TO NCI AND NCI SEEMED TO OPEN UP IT TO IT AFTER A WHILE. SO THAT'S NOT A--YOU HAVE TO READ THIS, RIGHT? WE THINK THIS IS ADDITIONAL INFORMATION, WE THINK IT'S USEFUL TO YOU, READ IT.OKAY? ALL RIGHT. SO THOSE ARE OUR KIND OF OVERALL ARCHING STATEMENTS THAT WE CAME UP WITH, YEAH? >> THE THOUGHT IS JUST OCCURRING TO ME OBVIOUSLY ALL THINGS CAN'T BE HERE TO ALL PEOPLE BUT THERE'S SO MUCH RELEVANCE HERE TO THE OTHER INSTRUMENTS THAT CAN BE USINGED FOR INFORMED CONSENT AND OTHER MEDIA THAT CAN BE USED SO I WONDER IF WE WANT TO HAVE ANOTHER NUMBERED PARAGRAPH THAT I'M HAPPY TO WORK ON WITH YOU ABOUT USING ELECTRONIC INFORMED CONSENT OR VIDEOS OR, YOU KNOW, I DON'T THINK THAT'S AN IRB, IS IT? WE HAD A STATEMENT AT THE VERY BOTTOM, WITH THE EXTRA STUFF, I TOOK IT ALL OFF, WE SHOULD SOMETHING SOMEWHAT I DROPPED--SOMETHING THAT I DROPPED OFF. >> JUST BECAUSE WAWE'RE TRYING TO DO IS PROVIDE UNDERSTANDABLE INFORMATION THAT WILL HELP THEM TO DECIDE WHETHER OR NOT TO PARTICIPATE. IT DOESN'T ALL HAVE TO BE IN THE TRADITIONAL PAPER FORM SO WE SHOULD JUST KEEP THAT IN THE BACK OF OUR MINDS AS WE THINK ABOUT THE DIFFERENT TOOLS. >> YOU KNOW THIS IS A LITTLE OFF TOPIC BUT SINCE YOU BROUGHT IT UP, WE GOT A CALL THE OTHER DAY FROM A PHARMACY WHO SAID IF YOU SEEN THE BMS WEBSITE ABOUT CONSENT? AND FIRST OF ALL ANOTHER COMPANY SAID WHY ARE YOU ASKING ABOUT THE BMS? WHAT ARE YOU TALKING ABOUT. THEY SAID WELL YOU HAVE THE GREAT WEBSITE UP ABOUT HOW TO REWRITE WEB FORMS AND YOU AS THE IRB WILL REJECT IT BECAUSE IT'S COMPLETELY DIFFERENT. SO WE WENT AND LOOKED TO THE BMS WEBSITE AND IT WAS REALLY--IT'S A FASCINATING WEBSITE AND I THINK IT LOOKS LIKE GOOD STUFF. THEY DID A LOT OF RESEARCH, THEY BROUGHT IN A LOT OF PATIENTS AND PROVIDERS AND EXPERTS ON LITERACY, ET CETERA AND THEY CAME UP WITH THINGS LIKE A WELCOME LETTER, IT STARTS THE WHOLE PROCESS OFF. AND THEN THERE'S A TABLE OF CONTENTS THAT'S VERY GRAPHIC LOOKING, KIND OF LOOKS LIKE A WEBPAGE MORE THAN A TRADITIONAL PAPER CONSENT FORM AND THEN KIND OF YOUR MAIN CONSENT DOCUMENTS WITH A LOT OF READABILITY TOOLS AND SPACING, ET CETERA. IT'S JUST--IT'S A NEAT WEBSITE. AND SO THE QUESTION REALLY DOES BECOME, HOW DOES THAT--HOW DOES AN APPROACH LIKE THAT THEN INTERRELATE WITH THE KEY INFORMATION REQUIREMENT? AND IT DOES BRING UP THE QUESTIONS OF WHAT >> IRBs GET HIGH BOUND AND TRADITION BOUND. THEY'VE DONE IT THIS WAY 20 YEARS. IT'S PERFECT. WHAT DO YOU MEAN? >> DAVID, I DID SEE A WELCOME AND THANK YOU FOR PARTICIPATING IN THE NCI STUDY WE WERE ASKED TO REVIEW. THAT WAS INCLUDED IN THE PROTOCOL. I DON'T KNOW HOW MANY PEOPLE USED IT. >> SO ONE THING THAT OCCURS TO ME AGAIN PARTLY COMING FROM OUR CONVERSATIONS EARLIER THIS MORNING, IS THAT WE MIGHT WANT TO ADD AS WE DEVELOP THIS OVER THE COMING MONTHS, START TO COLLECT TOOLS AND HAVE A SUPPLEMENT THAT HAS LINKS AND SUCH AND TOOLS WE WOULD ENDORSE. >> I THINK WE SHOULD AND THE THINGS WE HEARD IN THE PRESENTATION [INAUDIBLE]. ALL RIGHT. NOW WE'LL ON TO THE QUESTIONS. OKAY, QUESTION ONE. I WON'T READ THE WHOLE THING BUT BASICALLY STARTS OUT HOW DOES KEY INFORMATION VARY DEPENDING ON THE CLINICAL TRIAL DESIGN BEING USED AND THE SPECIFIC RESEARCH QUESTIONS BEING ASKED AND THE POPULATIONS BEING ASKED TO PARTICIPATES AND FOR INSTANCE THE TRIAL DESIGNS AND THREE LISTED HERE CHANGING WHAT WILL BE KEY INFORMATION. AND OUR ANSWER WAS, IT APPEARS YOU'RE LOOKING FOR A TAXONOMY BASED ON REGULATION AND WE DON'T THINK IT'S POSSIBLE AFTER WHICH IT WAS SENT TO US. SO WE PROBABLY SHOULD REVISE THE ANSWER TO SOME DEGREE AND SAY HERE'S A LOOK AT IT. SO WHAT WE ENDED UP SAYING IS BECAUSE TWEQUESTION THREE AND FOUR LOOKS AT METHODS LOOK AT QUESTIONS THREE AND FOUR. AND WE KIND OF SAID WE DON'T -- MAYBE WE NEED TO REVISE IT. WE DON'T THINK IT'S FEASIBLE BUT I'D LOVE TO HEAR COMMENTS ON YOUR THOUGHTS ABOUT THIS AND THE USABILITY AND PRACTICALNESS. >> SO WE HAD THIS CONVERSATION OVER BREAKFAST. I FIRST OPENED UP THE EXCEL SPREAD SHEET WITHOUT LOOKING AT THE TEXT AND I WAS LOST. I THEN READ THE TEXT AND TRIED AGAIN AND I THINK I NEED A WALKTHROUGH. I THINK I CAN GET THERE. -- PERHAPS IF WE THINK THAT ULTIMATELY IS A USEFUL TOOL THAT I THOUGHT WE MAY NEED A VOICEOVER VIDEO TO EXPLAIN HOW TO USE ULT -- IT. I THINK THERE'S SOMETHING THERE BUT I DON'T QUITE GET IT READING IT MYSELF. >> THINGS I'VE NOTICED -- WELL, I AGREE, I COULD USE SOME WALKING THROUGH. BUT THE TWO THINGS THAT JUMPED OUT AT ME WERE ONE WAS A CATEGORY FOR LIFE-THREATENING DISEASE AND EARLY STAGE CANCERS CAN BE LIFE-THREATENING DISEASE AND I SAW ALTRUISM FIGURING PROMINENTLY IN ONE OF THE LINES AND THOUGH MANY PATIENTS WANT TO CONTRIBUTE TO RESEARCH, I DON'T THINK IT SHOULD BE AN ELEMENT. >> DAVID, OKAY IF I TAKE A MINUTE? >> ABSOLUTELY. >> SO I APOLOGIZE FOR THE ROUGH NATURE OF THAT. IT WAS FOR PROOF OF CONCEPT AND IT WAS SENT OUT AND I TRIED TO EXPLAIN AFTER THE FACT. I THOUGHT I COULD DO THIS AND IT TURNED OUT TO BE NOT SO EASY BUT THE IDEA BEHIND IT WAS TO LOOK AT -- SO NORMALLY TAKING QUESTION ONE AT FACE VALUE HAVE YOU A TOX OMONY AND THERE'S THE POPULATION AND WHAT THE MOTIVATIONS ARE. IT WAS AN ATTEMPT TO TAKE TWO AND FORCE CONSIDERATION NOT TO SHORTCUT. AND THESE WERE NOT MEANT TO BE THE FINAL TAXONOMY AND THEN ALTRUISM CAME IN AND LIFE EXTENSION AND QUALITY OF LIFE AND OTHER THINGS. AND IT'S HARD TO SAY ONE TRIAL MAY ATTRACT DIFFERENT POPULATION. SO A PHASE 1 TRIAL FOR SOMEONE WHO EXHAUSTED OTHER AVENUES FOR ANOTHER TERMINAL DISEASE VARIES IN THE HOPE FOR LIFE EXTENSION BUT I THINK THERE ARE SOME INDIVIDUALS WHO WOULD PARTICIPATE IN SUCH A TRIAL TO MAKE SOMETHING WORTHWHILE OF THEIR SUFFERING. SO ALTRUISM I DO THINK PLAYS A ROLE AND THE KEY INFORMATION MAY BE DIFFERENT. THAT'S THE FIRST TABLE. AND THE SECOND TABLE IS WHAT WERE THE ROWS IN THE FIRST COLUMN, THE MOTIVATION OR INTERESTS OF PARTICIPANTS AND THEN CAME THE COLUMNS AND THE ROWS WERE WHAT INFORMATION WOULD SATISFY THOSE INTERESTS THEN YOU PUT THE WHOLE THING TOGETHER AND LIST IT. AS IT TURNS OUT AND AGAIN -- THIS WAS ONLY PROOF OF CONCEPT. YOU GET A BUNCH OF DIFFERENT TRIAL DESIGNS WITH WHAT IS KEY INFORMATION FOR THE TRIAL DESIGNS AND THEY FELL INTO GROUPS WHICH ALSO WAS DISTRIBUTED AS A SEPARATE DOCUMENT. AND THE SPECIFICS WERE NOT MEANT TO BE DEFINITIVE OR RIGHT. IT'S MY FIRST TAKE AND THE MORE I THOUGHT ABOUT IT THE MORE I THOUGHT ABOUT ONE GROUP AND IF YOU INCLUDE EVERYTHING, EVERYBODY GETS THE SAME INFORMATION AND IT BECOMES A USELESS EXERCISE SO IT REQUIRES SOME DISCRIMINATION BUT THAT WAS THE IDEA. >> HAVING LOOKED AT THIS IN OTHER AREAS AT SOME LEVEL A TAMM TAMMON -- TAXONOMY WON'T MEET THE APPROACH. IF YOU GO BACK TO THE ELEMENTS OF THE KEY INFORMATION, WHAT ARE THE BENEFITS AND S -- RISKS AND WHAT IS INVOLVED YOU CAN MAKE A TAXONOMY AND WHAT ABOUT THE EFFECT ON FUNCTIONAL ABILITY AND THE ABILITY TO DRIVE. NOW, SOME OF THOSE THINGS DEPENDING ON THE CIRCUMSTANCE COULD BE A RISK. THERE'S A RISK OF AFFECTING YOUR ABILITY TO DRIVE OR IT COULD BE A DISCOMFORT THAT IS A BURDEN AND THAT'S ONE OF THE DISCOMFORTS OF PARTS -- PARTICIPATING AND YOU MAY HAVE THE CONCEPT SHOW UP IN MORE THAN ONE AND THAT'S GOING TO VARY AND WHETHER YOU HAVE INFORMATION TO SHARE AND WHETHER IT MAKES A DIFFERENCE FOR THAT DECISION IS GOING TO CHANGE BASED ON THE POPULATION, RIGHT, THE ACTING TREATMENT, COMMENTING ON ABILITY TO DRIVE MAY HAVE NO RELEVANCE. IT THE CHANGE BASED ON THE INTERVENTIONS. IF THE INTERVENTION IS CAUSING THE ABILITY TO DRIVE RATHER THAN THE POPULATION HAVING THAT AS A FUNCTIONAL EFFECT OR IF THE TRIAL DESIGN HAS YOU DO THINGS THAT FOR THAT TRIAL ARE UNIQUELY -- YOU CAN COME UP WITH A TAXONOMY OF THE COMMON CONSIDERATIONS SOMEONE CAN LOOK AT WHEN THEY CREATE KEY INFORMATION FOR THIS SPECIFC TRIAL PROTOCOL. LOOK AT THIS LIST OF COMMON CONSIDERATION FOR BENEFITS, HOW ALTRUISM COULD BE ON THE LIST. COMMON CONSIDERATIONS FOR RISK AND FUNCTIONAL EFFECTS MAY FIT THERE AND SO ON AND PROVIDE THAT. NOT AS A YOU MUST COVER ALL THESE THINGS FOR ALL STUDIES, BUT THESE ARE THE COMMON THINGS TO PAY ATTENTION TO AND YOU'VE AT LEAST CONSIDERED THAT AND DOES IT APPLY WHEN CREATING KEY INFORMATION FOR THAT TRIAL? >> SO I COMPLETELY AGREE. IT WAS NOT SUPPOSED TO BE A CHECKLIST. I THINK THE ONLY ADDITIONAL STEP, WHICH MAY NOT BE USEFUL, IS TO TAKE THOSE STEPS AND MAP THEM TO WHAT INFORMATION WOULD ADDRESS THOSE CONCERNS. THAT WAS THE SECOND STEP. SO, AGAIN, THE OUTPUT WAS NOT MEANT TO BE NECESSARILY A REQUIRED LIST BUT POINTS TO CONSIDER AND WHAT PEOPLE IN THESE TRIALS -- AND AGAIN, I WOULD ENCOURAGE, IT WOULD BE USEFUL TO ME IF OTHERS WOULD TAKE THE TIME TO LOOK AT THAT AND CRITIQUE IT AND ADD COLUMNS AND ROWS AND PUT YOUR OWN Xs IN BECAUSE I DIDN'T COMMIT NEARLY THE TIME I SHOULD HAVE BECAUSE I DIDN'T FEEL I WAS THE AUTHORITATIVE SOURCE. >> WE SHOULD INCLUDE THIS AS AN SAMPLE AND SAY YOU ASKED FOR A VERSION OF THIS, HERE IT IS. >> I WOULD LOVE TO DO THAT BUT ONLY IF SOMEONE ELSE FILLS IT OUT TOO. IT WAS MEANT TO BE AN EXERCISE. IT'S SORT OF A BRAIN DUMP, IF YOU WILL. >> I THINK IT'S INFORMATIVE. HERE'S AN EFFORT. EVEN IF IT SHOWS IT'S DIFFICULT IT'S STILL INFORMATIVE. I DID HAVE A NOTE WE'D MENTION WE CAME UP WITH A TOOL, WHETHER WE ATTRIBUTE IT TO YOU OR NOT AND THERE'S A TOOL [INAUDIBLE]. OTHERS ON QUESTION ONE? ANYBODY FIND IT FUNDAMENTALLY A FLAWED ANSWER? DO WE NEED CHANGE? SANDRA. >> ARE PATIENTS IN CLINICAL TRIALS EVER TOLD WHO IS SPONSORING THE TRIAL? >> USUALLY. IS THAT SOMETHING WE WOULD CONSIDER TO BE STANDARD? >> IT'S VERY COMMON. I SUPPOSE THERE MAY BE IRBs THAT DON'T REQUIRE IT BUT I THINK IT'S VERY COMMON. >> OKAY. AND DO THEY TELL PEOPLE HOW THE INVESTIGATORS IS BEING BENEFITTED FROM SIMPLY DOING THE TRIAL? >> I CAN TELL YOU FROM MY EXPERIENCE IT GETS HARD TO DESCRIBE BECAUSE OF THE DIFFERENT CONTRACTUAL RELATIONSHIPS. SOMETIMES THE DOCTOR IS PAID DIRECTLY AND SOMETIMES THEY GET MONEY PAID DIRECTLY OR IN A SALARY. IT'S HARD TO ACCURATLY STATE. OFTEN TIMES THERE'S A STATEMENT THE INVESTIGATOR IS BEING PAID. >> QUESTION TWO CONSIDER WHETHER THE PREAMMAL SHOULD ENCOMPASS THE INFORMATION AND SHOULD IT BE CONSIDERED INFORMATION OR DESIGNED ON THE CONTEXT OF THE STUDY WOULD SOME OF THIS INFORMATION NOT NECESSARILY BE KEY? ARE THERE ADDITIONAL RECOMMENDATIONS WHAT SHOULD BE REQUIRED AND CONSIDERED KEY BEYOND THE LISTED ELEMENTS OF CONSENT DEPENDING ON THE DESIGN AND CONTEXT OF THE STUDY. THIS WAS THE MOST HEATED RESPONSE OF THE RESPONSE THE SUBCOMMITTEE'S CONSIDERED AND THE MOST VARIABILITY IN BELIEFS. WE DID ADD LINES 165 TO 171 HERE'S WHAT THE PREAMBLE SAID POTENTIALLY THE ELEMENTS, KEY INFORMATION, AND THEN WHAT WE SENSE FROM 173 TO 184 IS THAT SOMETIMES THOSE WILL BE SUFFICIENT AS KEY INFORMATION DEPENDING ON THE STUDY DESIGN. WE'VE MADE THE NOTE I MADE EARLIER FROM A COMPLIANCE PERSPECTIVE IT PROVIDES A SAFE HARBOR IF SOMEONE IS WORRIED ABOUT ENFORCEMENT BUT WE SHOULD SAID THERE SHOULD BE FLEXIBILITY TO INCLUDE INFORMATION THAT'S NOT AN ELEMENT OF CONSENT. IF THE INVESTIGATOR, THE IRBs, THE OTHERS THINK IT'S KEY INFORMATION ON A SUBJECT OF A GIVEN STUDY. AND WE ALSO THOUGHT THERE SHOULD BE FLEXIBILITY NOT TO INCLUDE ONE OF THE ELEMENTS IN THE PREAMBLE WHEN BECAUSE OF THE FACTORS OF THE RESEARCH IT'S NOT CONSIDERED TO BE KEY INFORMATION. KEY INFORMATION CAN VARY. AND THINGS THAT ARE KEY INFORMATION IN OTHER STUDIES ARE CENTRAL DESIGN AND STAN PLACEBO AND SIGNIFICANT COST INCURRED. THAT MAY BE KEY INFORMATION IN A GIVEN STUDY AND HOW MUCH TIME AND VISIT REQUIRED AND FUTURE CLINICAL CARE. SOMETIMES THERE'S STUDIES WHERE IF YOU TRY THE INVESTIGATIONAL DRUG FOR WHATEVER REASON YOU CANNOT GO BACK TO WHAT'S AVAILABLE OUTSIDE THE RESEARCH. WE THOUGHT THOSE WERE ALL EXAMPLES. WE CAN COME UP WITH MORE EXAMPLES, I WOULD THINK. WE ALSO MADE A COMMENT THAT IN THE PREAMBLE RISK AND BENEFIT SET THE FORESEEABLE RISKS AND DISCOMFORT TO SUBJECTS. WE NOTED SOMETIMES IT MAY BE FREQUENCY OR MAGNITUDE THAN THE FORESEEABLE RISKS THAT MAKES IT KEY INFORMATION AND OTHERS ARE NOT. WE MAY WANT TO HIGHLIGHT CERTAIN RISKS OF GREAT MAGNITUDE OR THE PREAMBLE IDENTIFYING [INAUDIBLE]. SO THAT IS THE RESPONSE TO QUESTION TWO AS IT SITS. SO COMMENTS? >> I THINK THE POTENTIAL SUBJECTS IN CLINICAL TRIALS MAY BE SOPHISTICATED ENOUGH TO UNDERSTAND MANY ARE RANDOMIZED, MANY INCLUDE PLACEBOS AND IF A PARTICULAR TRIAL IS NOT RANDOMIZED OR DOESN'T INCLUDE A P PLACEBO IT MAY BE WORTH STATING >> DAVID, WHILE I AGREE ABOUT INCLUDING COSTS, I RARELY SEE THAT HANDLED WELL ON AN INFORMED CONSENT. HAVING THE STATEMENT OF SIGNIFICANT COSTS COULD BE INCURRED AS A RESULT OF PARTICIPATION. I DON'T KNOW HOW MUCH THAT HELPS ESPECIALLY IN THE KEY INFORMATION. >> SO THERE ARE SOME STUDIES OUT THERE WHERE IT'S PAY TO PLAY THAT GET APPROVED SOMETIMES. THIS WILL COST YOU $50,000 -- >> THIS AKIN TO THE BENEFIT AS A STATEMENT OF BENEFITS. THAT'S IN THERE AND SATISFIES THE COMPLIANCE REQUIREMENT INADEQUATE AND SAYING THERE'S SIGNIFICANT COSTS THAT MAY BEING INCURRED IS INADEQUATE BUT IF THERE'S SIGNIFICANT COSTS SHOULD BE KEY AND TO BE EXPLAINED NOT A BLANKET STATEMENT. >> THE DIFFICULT ISSUE WITH ASSESSING COSTS IS OUR MEDICAL REIMBURSEMENT SYSTEM IN THE UNITED STATES IS HORRIBLY COMPLICATED. TO EXPECT SOMEBODY WRITING A CONSENT FORM FOR THE NUMBERS OF AN IRB CAN COME UP WITH A GOOD ESTIMATION OF WHAT A COST MAY BE IS NOT EASY FOR THOSE PEOPLE TO DO. >> IT'S NOT EASY FOR THE PARTICIPANT. THERE'S THE ISSUE OF WHAT IS ROUTINE CARE, WHAT'S INVESTIGATIONAL. IT'S VERY FRUSTRATING. >> BUT IT'S STILL KEY. I THINK THAT'S TRUE IN CLINICAL CARE TOO. I DON'T KNOW IF ANY OF YOU HAVE TRIED TO FIND OUT WHAT I PROCEDURE IS SUPPOSED TO COST AND YOU'RE SENT TO SIX DIFFERENT PLACES BECAUSE IT'S NOT DISSIMILAR. WE NEED TO ACKNOWLEDGE THAT. >> I THINK IT WILL BE IMPOSSIBLE TO COME UP WITH A LAUNDRY LIST TO BE CONSIDERED AS KEY INFORMATION ABOUT THE I WONDER IF ANOTHER EXAMPLE MAY BE WORTH ADDING AND THAT'S POTENTIAL IMPACT ON THIRD PARTIES. THERE ARE SOME STUDIES WHERE YOU'RE TRIAL PARTICIPATION CAN HAVE THE POTENTIAL TO ADVERSELY IMPACT OTHERS. >> YOU'RE THINKING LIKE A GENE TRANSFER STUDY WHERE THERE'S SHEDDING. >> THERE'S AN EXAMPLE. CAREGIVERS AND RADIO ACTIVE AGENT. THERE'S THE NEWER HIV RETRO VIRAL PAUSE STUDIES THAT MAY INCREASE THE RISK OF TRANSFERABILITY AND OTHER THINGS. >> AND WHETHER INVOLVEMENT IN A CLINICAL TRIAL WOULD IMPACT YOUR ELIGIBILITY FOR HOSPICE CARE. WE CAN THINK ABOUT IT MORE WHETHER THAT'S AN EXAMPLE BUT IT SEEMS THAT WOULD BE QUITE IMPORTANT FOR PEOPLE TO KNOW. >> I THOUGHT THAT'S A BIZARRE STATEMENT. >> BUT THAT IS AN EXAMPLE OF FUTURE IMPACT OF CARE. FOR HOSPICE CARE HAVE YOU TO BE FINISHED WITH YOUR CLINICAL INTERVENTIONS SO I DON'T KNOW WHETHER CLINICAL TRIAL COUNTS FOR ELIGIBILITY OR NOT. >> AGAIN, THIS IS STILL A ROUGH DRAFT. WE CAN DEBATE THESE AND TAKE THEM OUT. >> AND WHAT ABOUT THE ABILITY OF DAILY LIVING AND DO YOUR JOB -- WHATEVER YOUR ACTIVITIES ARE. >> MOST STUDIES WILL EXCLUDE YOU. YOU CAN'T DO THOSE THINGS. >> I'M TALKING ABOUT WORK. THEY'RE NOT GOING TO EXCLUDE YOU IF YOU CAN'T WORK. IF THE FUNCTIONAL IMPACT OF THE SIDE EFFECTS ARE LIKELY TO MAKE IT THAT YOU CAN NO LONGER WORK OR DO YOUR BASIC ACTIVITIES, I THINK -- >> I'M GOING TO PUT A NOTE. I THINK WE ADDRESSED THIS FURTHER DOWN BUT I'LL PUT A NOTE I THINK IT WAS COVERED. >> AND I THINK WE'RE TALKING ABOUT FUNCTIONAL IMPACT OF BEING IN THE STUDY NOT WHAT YOU BRING TO IT, RIGHT? ALL RIGHT WE IDENTIFIED QUESTION THREE AND FOUR AND FOUR SAID GIVEN ALL THE COMPLEXITIES, WHAT TOOLS OR STRATEGIES DO YOU RECOMMEND SUCH AS ALGORITHM AND GENERAL POINT TO CONSIDER. SO WE COMBINED THE ANSWER AND NOTED IN 224 AND 225 WHETHER THE CALIFORNIA BILL OF RIGHTS WAS A GOOD MODEL AND THE CONSENSUS IS WE OVERRULED THAT. I THINK IT IS USEFUL. HEARING NO SWELL IN THAT DIRECTION, CAME UP WITH TOOLS. THE FIRST IS THE SPREAD SHEET TOOL FROM STEVEN. I HAD STEVEN GO BACK AND EXPLAINED TO ME HOW IT WAS LABELLED AND I GOT IT RIGHT. THERE'S THE NAME OF THE DOCUMENT AND A SHORT DESCRIPTION IF WE WANT TO INCLUDE THAT. AND THE NEVER GAVE ME MEAT TO PUT IN HERE. SO I DON'T KNOW WHAT IT MEANS. WE CAN GET INPUT ON IT. NANCY. >> WELL, IT'S NOT REALLY A TOOL. IT'S MORE OF -- AND I WANT TO WORK ON THIS FURTHER AND I KNOW THERE'S SUBCOMMITTEE MEMBERS WHO WANT TO WORK ON THIS FURTHER. IT ISN'T A TOOL SO IT PROBLEM BELONGS IN THE FIRST SECTION BEFORE WE GET TO THE QUESTION. >> THE IDEA WAS COULD WE RETHINK THINGS AND COULD THE INFORMATION NOT JUST PROVIDE DATA BUT PROVIDE POTENTIAL SUBJECTS WITH AN APPROACH TO THINKING ABOUT TRIAL PARTICIPATION. >> YOU AND NANCY CAN WORK ON IT. OTHER COMMENTS ON THE FRAMING? ALL RIGHT. THE NEXT ONE GOES BACK TO MY DEGREES AND WE CAN PROBABLY THROW THIS AWAY BUT I'LL GIVE A BRIEF DESCRIPTION. IN THE BELMONT REPORT INVOLVED IN ETHICS THERE WERE BOOKS AND WRITINGS ON CLINICAL DECISION AND IN HIS BOOK, MEDICAL ETHICS. HE CAME UP WITH A TOOL AROUND THE SEATTLE AREA, HOSPITAL AND CLINICAL COMMITTEES USED ALL THE TIME AND SPREAD ACROSS THE NORTHWEST AND HE WAS THERE FOR A GOOD PORTION OF HIS CAREER AND HE CAME UP WITH A FOUR-BOX METHOD WHERE YOU START WITH MEDICAL INDICATIONS, PATIENT PREFERENCE, QUALITY OF LIFE AND EVERYTHING ELSE. THAT HELPED YOU TO FRAME QUESTIONS LIKE SHOULD WE PULL THE PLUG, SHOULD THIS PATIENT BE ALLOWED TO TURN DOWN BURN TREATMENT, ETCETERA. IT WAS AN EFFECTIVE TOOL FOR THOSE KINDS OF DECISIONS. NOW, IT WAS ISOLATE TO A SINGLE PATIENT OR CLINICAL DECISION IN A LIMITED ASPECT. IT'S A GREAT TOOL. IT WORK REALLY WELL. SO I WAS WONDERING IF WE CAN SOMEHOW EXPAND THAT TO THIS QUESTION. I KIND OF GAVE UP AND WROTE DOWN VARIOUS THINGS FOR A WHILE AND THOUGHT THERE'S TOO MANY ELEMENTS. WE'RE BEYOND FOUR BOX FOR DETERMINING KEY INFORMATION. FOR CLINICAL RESEARCH. BUT IT DID BRING UP THE POINT THERE ARE TWO LAWS OUT THERE THAT KIND OF IN A WAY DO ADDRESS WHAT COULD BE CONSIDERED KEY INFORMATION FOR GIVE ENTYPES -- GIVEN TYPES OF INFORMATION AND WHEN THERE ARE DONORS IN STEM CELL RESEARCH THERE IS CONSENT AND IT'S NOT THE ELEMENTS OF CONSENT WE HAVE AT THE HHS REGULATIONS. pTHERE ARE MEDICAL RISKS AND THE EGGS WILL NOT BE USED FOR OTHER PURPOSE AND THE RESEARCH IS NOT INTEND TO DIRECTLY BENEFIT THE DONOR OR OTHER INDIVIDUAL AND WHETHER STEM CELLS WILL BE DERIVED AND THE METHOD AND THE STEM CELLS WILL BE GROWN IN THE LAB AND SHARED WITH RESEARCHERS, IF THEY ARE TO BE IMPLANTED IN OTHER PATIENTS THE DONORS WILL RECEIVE NO PAYMENT AND SO ON. AND IT'S INTERESTING. AL JOHNSON HAD THIS IDEA THAT THERE'S TOPIC THAT COME UP AND HAVE YOU TOPICS THAT ARISE IN HIV STUDIES THAT DO NOT ARISE IN CANCER STUDIES OR ARISE WITH VACCINES AND YOU CAN HONE IN ON THE TOPICS. THIS IS WHERE IRB MEMBERS GET GOOD. THEY GET GOOD AT PATTERN RECOGNITION AND YOU KNOW WHAT YOU'RE LOOKING FOR IN A DEPRESSION STUDY. HAVE YOU AN HIV VACCINE STUDY YOU KNOW WHAT YOU'RE LOOKING FOR. THERE'S AN IDEA OF IDENTIFYING TOPICS. I THINK IT GETS BACK TO THE PROBLEM WITH STEVEN'S TOOL, THERE'S TOO MUCH VARMENT. VARIABILITY. YOU CAN GET GOOD AT IT BUT IT'S HARD. AND IF YOU LOOK AT THE RIGHT TO TRY LAW OUT OF THE STATES, A MODEL LEGISLATION, THEY CAME UP WITH SIX ELEMENTS OF CONSENT WHICH DUMPED OVERLAP WITH THE HHS REGULATIONS. THEY THOUGHT THEY WERE IMPORTANT KEY INFORMATION. IS THERE SOMETHING TO GATHER OR PUT IN THE RECOMMENDATION TO IDENTIFY WHAT IS KEY INFORMATION FROM A LEGISLATIVE STANDPOINT? I WOULD LOVE YOUR INPUT AND PERHAPS THE WHOLE SECTION WE SHOULD GO OVER FROM TOP TO BOTTOM [INAUDIBLE]. >> I'M NOT A FAN OF THIS APPROACH BECAUSE I THINK THE FIRST EXAMPLE ABOUT FERTILITY AND THE OCYTE DONATION IS SO FAR AFIELD AND THERE'S GOOD OVERLAP WITH THE REGULATIONS SO WE SEE RISKS AND BENEFITS AND POINTS ON COST AND IMPACT ON OTHER CARE OPTIONS AND THOSE ARE THINGS WE PUT EARLIER AND THAT SAID, THERE ARE ELEMENTS OF THIS THAT ARE POTENTIALLY MORE SPECIFIC UNDER THE BROADER HEADING. I DON'T KNOW WE NEED THIS ADDITIONAL TOOL TO GET US THERE. AND WITH BEST AND WORST OUTCOMES IT'S A MORE SPECIFIC WAY TO THINK WITH THE PRIORITY OF INFORMATION WE WANT TO GIVE TO PEOPLE IN THIS CONCISE SUMMARY AND THERE'S COSTS AND IMPACT ON HOSPICE THERE. BUT I THINK THOSE PIECES ARE ALREADY WOVEN INTO THE EARLY PART OF THE DOCUMENT. IF YOU DON'T MIND SCROLLING UP TO THE CALIFORNIA EXAMPLE -- IF YOU DON'T UNDERSTAND RESEARCH THAT'S A BROAD PRINCIPLE WITH CONSENT AND THE OTHERS ARE SPECIFIC TO THIS USAGE. MY OVERALL REACTION IS IT'S UNNECESSARY. >> I DISAGREE WITH THE CHARACTERIZATION OF THE CALIFORNIA REGULATION OF NOT BEING IN 116. IF YOU THINK ABOUT SOME OF THESE THE EGGS WILL NOT BE USED FOR REPRODUCTIVE PURPOSE AND WHETHER STEM CELL WILL BE DERIVED. THOSE ARE ALL ABOUT WHAT'S GOING TO HAPPEN IN THIS. SO I'D ECHO WHAT HOLLY IS SAYING BECAUSE THE EXAMPLES THEMSELVES DIDN'T SEEM SO DISTINCT THEY ADDED SOMETHING FOR ME. >> WHAT I SAW IN THIS, IS THAT YOU CAN LEAVE A LOT OF IT OUT AND STILL COMPLY WITH THE HHS AND FDA REGULATIONS. YOU CAN CERTAINLY REASON THEY SHOULD BE REQUIRED BECAUSE OF THE ELEMENT OF PURPOSE, ET ETCETERA BUT I ALSO THINK THEY'RE NOT REQUIRED NECESSARILY. >> I THINK THEY WOULD BE REQUIRED FOR CERTAIN TYPES OF RESEARCH. I MEAN, I WASN'T AWARE OF THE CALIFORNIA LAW AND I'M SURPRISED IT'S SO UTTERLY SPECIFIC FOR THE USE OF EGGS. ANY NUMBER OF VIRTUALLY ALL STUDIES INVOLVING STEM CELL GENERATION WOULD REQUIRE AT LEAST SOME OF THESE POINTS TO BE INCLUDED. AND WHEN IT COMES DOWN TO IT, THIS WHOLE SECTION WOULD BE APPROPRIATE TO HENRIETTA LOTT. I THINK A LOT SHOULD BE CONSIDERED FOR INVESTIGATORS DOING THESE KINDS OF STUDIES. >> SO I HEAR A DELETE INTEREST -- DELETE FROM HOLLY AND LESLIE. COMES DOWN TO QUESTION ONE. UNLESS YOU'RE GOING TO DO IT ON A CASE-BY-CASE BASIS YOU'RE SUGGESTING AGAIN THAT DIFFERENT KINDS OF STUDIES IN DIFFERENT POPULATIONS HAVE DIFFERENT KEY INFORMATION THAT PERHAPS WE CAN IDENTIFY. >> IT'S NOT A VERY WORKABLE TOOL. I WOULD LIKE TO NOTE THAT ANY EFFORT I MAKE FOR PHILOSOPHICAL REFERENCES IN RECOMMENDATIONS GET TANKED. I'M IN THE SURE IT'S NOT A USEFUL TOOL. I THINK ABOUT MY SPREAD SHEET WHICH I CONTINUE TO COME BACK TO BECAUSE IT'S THE IDEA -- NO, SO YOU NEED TO HAVE SOME BASIS FOR FILLING THAT OUT AND I'M NOT SURE THIS DOESN'T PROVIDE YOU THAT BASIS. SO THE SPECIFIC LOOKING BACK AT CASES AND SPECIFIC EXAMPLES IS HOW WE WOULD DO THAT. I THINK THEY DO COMPLEMENT ONE ANOTHER. >> YOU HAVE TO USE THE MIC. >> I SEE YOU'RE SHOWING DOMAIN SPECIFIC EXPECTATIONS. CANNOT SPECIFY ALL OF THE DOMAINS UP FRONT IN A GENERAL RULE BUT OVER TIME AS DOMAIN SPECIFIC KEY INFORMATION NEEDS BECOME APPARENT, HAVING THAT WILL ACTUALLY MAKE IT EASIER TO APPLY WHAT IS KEY INFORMATION NEEDS AND SPECIFIC DOMAINS. I THINK IT HAS A LOT OF VALUE BUT IT MAY NOT BE READY FOR IMPLEMENTATION UNTIL THERE'S TIME TO FIGURE OUT WHAT ARE THE DOMAINS THAT NEED IT AND THE DOMAIN SPECIFIC KEY INFORMATION NEEDS AS YOU GO ON TO APPLY IT. >> SO PERHAPS OVER A NUMBER OF YEARS YOU COULD BUILD SOMETHING UP. >> RESEARCH WILL CONTINUE TO ADVAN ADVAN ADVANCE AND NEW DOMAINS AND THE NEED FOR SPECIFIC DEFINITIONS WILL ONLY GROW OVER TIME. >> I DON'T REMEMBER IF WE PUT THIS IN OUR TOPIC IN THE RE PREAMBLE. WHATEVER WE COME UP WITH WE EXPECT THAT TO BE THE FINAL ANSWER. THIS IS AN AREA THAT'S NEW AND WE'RE GOING TO NEED THE ONGOING ASSESSMENT OF PEOPLE AND PARTICIPANTS AND AS THE GOING TO EVOLVE. I THINK WE SHOULD MAKE THAT EXPLICIT SO PEOPLE AREN'T LOOKING FOR A FINAL ANSWER. >> WE CAN DO THAT UP IN THE STATE WITHOUT RESEARCH. ALL RIGHT. ALTERED. ANY OTHER COMMENTS ON THE SECTION? SO THE NEXT THING WE HAVE IS THE CLINICAL CONVERSATION TOOL. THE OUTLINE OF THIS TOOL IS WE SHOULD MAKE KEY INFORMATION LOOK LIKE AND FEEL LIKE OR A DISCUSSION BETWEEN A PHYSICIAN AND A PATIENT TRYING TO DECIDE WHAT TO DO FOR A GIVEN DISEASE OR [INAUDIBLE]. >> I DON'T KNOW HOW TO IMPLEMENT THIS. AND IN TRYING TO THINK WHAT A DOCTOR WOULD HAVE OR THE CONVERSATION A DOCTOR WOULD HAVE. WHEN WE TALKED ABOUT THIS IN THE SUBCOMMITTEE, EXPANDING REALLY ON JERRY'S COMMENTS AT THE BEGINNING OF THE MEETING, IT SEEMED TO ME LIKE THE CONVERSATION -- A DOCTOR, AN IDEAL DOCTOR OR PERHAPS A REASONABLE DOCTOR WOULD HAVE IN A CLINICAL SITUATION AND IF WE CAN GET DOCTORS NOT LOOKING AT THE SCREENS AND STILL COMMUNICATING WITH PATIENTS BUT THE SENSE OF WHAT A DOCTOR SHOULD BE TO WRITE THIS SECTION, WE WOULD BE WAY AHEAD OF THE GAME. I'M NOT SURE WE -- AND IT'S AN ASPIRATIONAL GOAL. I DON'T KNOW HOW YOU DO THAT PRACTICALLY AS A TOOL. >> I THINK IT'S A METHOD FOR DECIDING WHAT IS KEY INFORMATION. >> YOU HAVE FINAL EDITING AUTHORITY. SOMETHING WE SHOULD KEEP? I SEE ONE SHAKING NO. >> I'M WONDERING IF IT'S NOT, NOT AS A TOOL PER SE BECAUSE I THINK IT IS SOMETHING DIFFERENT BUT AS MAYBE IN THE BEGINNING A SORT OF SOMETHING ONE MIGHT WANT TO MODEL IS THAT CONVERSATION THAT WHEN YOU PULL OUT THAT KEY INFORMATION IN THAT CONVERSATION INCLUDING WHAT I THINK IS A VERY HELPFUL TOOL, THE BEST-CASE, WORST-CASE SCENARIO IN HELPING SOMEBODY MAKE A DECISION AND TALK ABOUT WHAT THE EXPERIENCE AND THAT GOES TO THE COMMENT ABOUT FUNCTIONAL -- WHAT DOES IT LOOK LIKE IF WE GO DOWN THIS PATH AS BEING A GUIDANT PRINCIPLE AND WE MIGHT WANT TO THINK ABOUT THAT BUT NOT SO MUCH AS A TOOL BECAUSE I THINK IT DOESN'T WORK SO WELL IN A WRITTEN PIECE OF KEY INFORMATION AT THE FRONT END. >> NANCY. >> FOLDS INTO THE THE FRAMING DISCUSSION. >> AS AN IRB, WE HAVE SEEN 30 FORMS AND THINGS AND WE DEFAULT TO CONCEPT IS A PROCESS, NOT A FORM. I THINK -- SO MY INTERPRETATION OF THE RULE AND CHANGES IN THIS IS THAT THAT'S FINE TO SAY BUT THEN WE HAVE NO IDEA HOW THAT'S IMPLEMENTED AND WE HAVE NOTHING IN THE CONSENT THAT TRIES TO REFLECT THE VALUES AND THAT'S PART OF WHAT THIS IS TRYING TO DO AND PART OF WHAT THE FRAMING IS TRYING TO ADDRESS IN SOME EXTENT. THE DANGER IS, WE DON'T WANT PEOPLE THINK THEY SHOULD HAVE TO SUBSTITUTE BUT THE CONSENT SHOULD BE MORE RESPONSIBLE. WE SHOULDN'T BE ABLE ANY LONGER TO SAY YOU CAN WRITE WHATEVER YOU WANT BECAUSE IT'S ALL A PROCESS. SOMEBODY WILL GO THROUGH -- >> THE REASON I WAS SHAKING MY HEAD NO, AT LEAST THE FIRST THREE WERE A, I AGREE WITH STEVEN THAT DEFINING WHAT AN AN IDEAL PHYSICIAN SHOULD BE IS VIRTUALLY IMPOSSIBLE. TWO, NOT ALL CLINICAL TRIALS ARE RUN BY PHYSICIANS AND NUMBER THREE, NOT ALL PHYSICIANS WHO RUN TRIALS ARE USED TO TALKING WITH PATIENTS. I WOULD LOOK AT RADIOLOGISTS AND PATHOLOGISTS AND SO FORTH. I DON'T REALLY SEE HOW FRAMING THIS TOOL IN TERMS OF PHYSICIANS IS APPROPRIATE. >> SO I JUST WANT TO CLARIFY. SO IN THOSE TRIALS THAT ARE NOT RUN BY PHYSICIANS, THE CONCERN IS THAT THE KIND OF CONVERSATIONS YOU HAVE IN CHOOSING A CLINICAL COURSE THAT REFLECTS YOUR PERSONAL VALUES AND LIFESTYLE AND QUALITY OF LIFE AND STATUS, YOU MIGHT HAVE IN A REALLY GOOD CONVERSATION WITH YOUR DOCTOR, THERE'S NO OPPORTUNITY. THE INVESTIGATOR DOESN'T KNOW HOW TO DO THAT, IT'S NOT THEIR JOB, IT'S NOT THEIR TRAINING. THAT DOESN'T MEAN THAT SOMEONE SHOULDN'T HAVE THAT CONVERSATION IN THE IDEAL WORLD. THAT'S WHAT THIS GETS TO. IT DOESN'T SAY IT'S THE P.I. IT'S THE SENSE OF IT'S SOMEONE USED TO TAKING THOSE THINGS INTO ACCOUNT AND ACTUALLY UNDERSTANDING THE IMPLICATIONS OF THAT. THAT'S THE CONVERSATION THAT YOU WANT TO HAVE AT THE BEGINNING. >> I'M GOING TO DEFEND IT A LITTLE BIT. I DON'T KNOW IT BELONGS HERE. I'M NOT SURE WHERE IT BELONGS BUT I THINK IN MY MIND I THINK THERE IS A CORSET OF INFORMATION THAT MOST PHYSICIANS WOULD AGREE HAVE TO BE TRANSMITTED DURING A CLINICAL DECISION MAKING AND WHETHER YOU'RE GOOD AT TRANSMITTING THAT OR NOT IS A DIFFERENT ISSUE. AND THAT WOULD BE SORT OF ANALOGOUS TO THE KEY INFORMATION. I THINK THE DIFFICULTY WE'RE ALWAYS STRUGGLING WITH IS THERE'S THE SUPPLEMENTAL INFORMATION AND THERE'S INFORMATION THAT WE CAN'T ALWAYS DO IN THE CIRCUMSTANCE BUT YOU CAN EMULATE THAT AND COUNTER TO IDENTIFY THE CORE FEATURE, CORE ELEMENTS OF INFORMATION. AND FOR ME IT'S A USEFUL EXERCISE IN THINKING ABOUT HOW TO DISCUSS TRIAL PARTICIPATION WITH A PARTICIPANT. >> AND A LOT OF US DON'T HAVE THE KNOWLEDGE BASE. SANDRA. >> THERE'S A CONVERSATIONAL TONE AND I THINK ONE OF THE THINGS THAT'S PARTICULARLY INTERESTING ABOUT THE VLS MATERIALS IS THEY START WITH THIS LETTER WHICH IS EMPATHETIC AND CONVERSATIONAL IN TONE. I THINK THAT'S A VERY IMPORTANT FEATURE. THE OTHER THING THAT THEY DO, THAT I THINK IS REALLY INTERESTING AND WE HAVEN'T TALKED ABOUT, THEY START OUT BY EMPHASIZING THE VOLUNTARINESS OF THE PARTICIPATION AND SOMETHING THEY DON'T SAY IS YOUR DECISION NOT TO PARTICIPATE DOESN'T MEAN WE WON'T TAKE CARE OF YOU ANYMORE. WE WILL STILL LOVE YOU IF YOU DON'T PARTICIPATE. BUT THE EMULATING THE NOTION OF A CONVERSATIONAL AND EMPATHETIC TONE IS SOMETHING WE WANT TO RAISE AS A NICE FEATURE. NOT A REQUIREMENT BUT A NICE -- >> THERE'S SOMETHING WE BROUGHT UP THAT'S WORTH THE GROUP THINKING ABOUT IS WHETHER OR NOT WE SHOULD HAVE ANY DISCUSSION OF THE CONSENT PROCESS. WE HAVE ZERO IN THIS DOCUMENT ON PROCESS. >> I THINK WE SHOULD TAKE THE OPPORTUNITY TO DO THAT. THE THING AS AN INDIVIDUAL AND AS THE SUBCOMMITTEE LEVEL AND WE STRUGGLE WITH THE FACT THAT KEY INFORMATION -- THERE'S A LARGE PART OF THAT THAT'S SUBJECTIVE AND IS GOING TO BE DEPENDENT ON THE INDIVIDUAL. -- THE INDIVIDUAL PARTICIPANT. HAVING THE OPPORTUNITY TO EMPHASIZE THAT, YES, WHILE WE'LL HELP YOU FIGURE OUT THE CORE ELEMENTS TO BE WRITTEN DOWN, YOU NEED TO IN THAT ONE-ON-ONE CONVERSATION, CONSIDER THE UNIQUE FEATURES OF EACH INDIVIDUAL SITUATION BECAUSE THEY WILL DIFFER. FOR SOME PATIENTS IT WILL TAKE ME AWAY FROM WORK. I CAN'T MAKE THAT MANY TRIPS. I DON'T WANT TO SPEND FOUR DAYS IN THE HOSPITAL GETTING A TRANSFUSION AND FOR OTHERS IT WILL BE VERY DIFFERENT. >> FOR THE REASONABLE PEOPLE. >> AS PART OF THE CONSENT PROCESS, HAS THE SUBCOMMITTEE THOUGHT ABOUT COMMENTING ON THE TIMING OF WHEN THE CONSENT TAKES PLACE AND WHO INTRODUCES THE CONSENT AND WHETHER THE SITUATION IS AT ALL COERCIVE OR POTENTIALLY PERCEIVED TO BE COERCIVE? THOSE ARE ELEMENTS OF CONSENT THAT ARE CONTEXTUAL. DO PEOPLE GET TIME TO TAKE IT HOME AND TALK ABOUT IT AND FOR SOME IT'S VERY IMPORTANT I WONDER IF THE SUBCOMMITTEE THOUGHT ABOUT COMMENTING ON THAT? >> NO. THAT HAS NOT COME UP. >> DO YOU USUALLY SEE THAT WRITTEN INTO THE LONG FORM CONSENT. TAKE THIS CONSENT FORM HOME AND THINK ABOUT IT AND DISCUSS IT WITH YOUR FAMILY AND FRIENDS. I THINK THAT TYPE OF WORDING IS -- >> BUT IN ORDER TO MAKE THAT MEANINGFUL YOU HAVE TO THINK ABOUT WHEN YOU'LL INTRODUCE THAT TRIAL AND YOU ALLOW PEOPLE THAT KIND OF TIME. IT COULD BE IN THE CONSENT FORM BUT I THINK THE PROCESS IN WHICH IT'S DONE AND HOW YOU THINK ABOUT WHEN YOU TALK TO A PATIENT VERSUS WHEN THEY ABSOLUTELY HAVE TO DECIDE WHETHER THEY SIGN UP OR NOT AND HOW THIS IS APPROACHED IS PART OF THE PROCESS OF VOLUNTARINESS AND RESPECT. >> IT SOUNDS LIKE A NOTE TO INVESTIGATORS RATHER THAN GUIDANCE TO THE PEOPLE PREPARING THIS DOCUMENT. >> THAT'S WHY I ASKED ABOUT WHETHER THE SUBCOMMITTEE HAD THOUGHT ABOUT IT AND APPARENTLY NOT BUT PERHAPS IT DOESN'T NEED TO BE TALKED ABOUT. >> I'LL PUT MAYBE NOT APPLICABLE. THIS IS ABOUT IDENTIFYING KEY INFORMATION ON THE PROCESS. WE'LL KEEP DISCUSSING. >> DAVID, THE WHOLE DISCUSSION OF PROCESS AND DOCTOR CONVERSATIONS AND SUCH MAKES ME THINK PART OF OUR TASK, IN EVERY ONE OF THOSE CONVERSATIONS, WHAT MAKES THEM SPECIAL IS THEY ARE INDIVIDUALIZED. AND ANOTHER WAY TO FRAME THE KEY INFORMATION, THE STUDY SPECIFIC KEY INFORMATION IS WHAT WE CAN PULL OUT OF THOSE DISCUSSIONS THAT ARE NOT INDIVIDUALIZED. SO THERE MAY BE THINGS THAT ARE PART OF THE TRIAL OR PART OF THE POPULATION CHARACTERISTICS OF THE SUBJECT WE CAN ANTICIPATE THAT WE CAN ARTICULATE HERE BUT EXPLICITLY ACKNOWLEDGING THIS NOT A SUBSTITUTE FOR THAT CONVERSATION. I THINK WE SHOULD STAY AWAY FROM CONSENT PROCESS. I THINK IT'S SO OVERUSED. CONSE SOME PLACES ARE GREAT AT IT AND SOME AREN'T DOING IT AT ALL. I THINK THAT'S A DIFFERENT FRAMING FOR THE KEY INFORMATION. MAYBE WE DON'T HAVE TO LEAVE ALL OF THIS FOR THE P.I. TO FIGURE OUT. >> THE NEXT IS THE LIST OF QUESTIONS TOOL BECAUSE NOBODY HAD A THEORY OR FRAMEWORK BEHIND THIS BUT WE THOUGHT WERE GREAT QUESTIONS THAT MIGHT WORK. I DID MENTION WE HAVE -- THERE'S NO UNDERLYING THEORY FOR THIS TOOL, BUT, PERHAPS THESE ARE THE TYPES OF QUESTIONS THAT CAN HELP PEOPLE IDENTIFY KEY INFORMATION. WHAT THE MODEL IS, THE INFORMATION AND WHAT THE SUBJECT NEEDS TO DECIDE TO JOIN THE STUDY OR THE SUBJECT WILL NOT JOIN THE STUDY. WHAT IS THE RESEARCH QUESTION THE STUDY IS TRYING TO ANSWER. ETCETERA, WHAT IS UNFAMILIAR, WHAT INFORMATION IS BEING COLLECTED BY ME. IT BOTHERS ME WE DON'T HAVE AN ORGANIZING PRINCIPLE OTHER THAN IT SEEMS KEY. Z YOU DON'T HAVE AN ORGANIZING PRINCIPLE FOR THE QUESTION OR FOR THE FACT YOU'RE USING A QUESTION AND ANSWER FORMAT? >> FOR THE QUESTIONS. >> BECAUSE THE QUESTION AND ANSWER FORMAT HAS A FRAMING DEVICE. THE IDEA OF HAVING QUESTIONS AND ANSWERS AND FRAMING PRESENTING INFORMATION IN THAT WAY IS PRETTY WELL TESTED. THE SPECIFIC QUESTIONS. >> WHEN I WAS READING THIS I LIKED THAT IT WAS DIFFERENT IN HOW STUDIES COULD BE AND MAYBE WE WANT A TOOL TO HELP EACH INDIVIDUAL STUDY THINK THROUGH, TRULY, WHAT IS THE KEY INFORMATION THAT I WANT TO BE CONVEYING. AND THIS WALKING THROUGH MAY HELP ILLUMINATE THE THREE THINGS I WANT MOST OF ALL. AS I WAS READING IT REMINDED ME OF A TEST OF COMPREHENSION IN THE HIV TRIALS AND YOU THINK THE INFORMATION IS SO KEY LIKE WE DON'T KNOW IF IT WILL PROTECT YOU BUT IT CAN HELP FRAME WHAT IS THE THING WE THINK IS SO IMPORTANT HERE. SOME OF THE QUESTIONS ON LOOKS LIKE 352, I THINK THERE WERE A COUPLE DIFFERENT THINGS EMBEDDED IN THAT PARTICULAR QUESTION. SO THERE MAY BE SOME WORK TO BE DONE BUT I THOUGHT PEOPLE MAY FIND IT USEFUL IN SORT OF FIGURING OUT WHAT IS IT THAT THEY'RE GOING TO ACTUALLY INCLUDE COUPLED WITH THE REGULATORY SUGGESTIONS. I THINK THE IDEA IS IT'S A TOOL THAT COULD BE USED BY THE PEOPLE DRAFTING THE CONSENT WITH INPUT. >> I SEE THESE AS QUITE GENERIC POINTS. WITH THE IRB I WOULD EXPECT ALL THE POINTS TO BE CONSIDERED OR EXPLICITLY STATED IN THE CONSENT FORM. I THINK YOU CAN ADD TO THE LIST THE POINT RAISED EARLIER THAT WILL YOUR CARE BE AFFECTED BY YOUR CHOICE OF PARTICIPATING OR NOT. >> I THINK THAT'S ALREADY THERE IN 357. >> SO I THINK THIS IS -- IF WE HAD TO COME UP TODAY WITH A SINGLE APPROACH, I THINK THIS WOULD BE IT. WE WOULD ADD THE BEST AND WORST THINGS AND ADD THINGS TO THE LIST. BUT I THINK ONE APPROACH TO ALL OF THIS -- AND I MAY END UP BEING THE ONLY PRACTICAL APPROACH IS TO ARTICULATE THE NUMBER OF QUESTIONS WRITTEN SO AS TO ILLICIT ANSWERS. BEHIND THESE ARE ALL REGULATORY CONSENT, THERE'S NOTHING NEW BUT WRITTEN IN A WAY TO ILLICIT A RESPONSE THAT'S PARTICIPANT SENSITIVE AND CENTERED WHICH I THINK IS IMPORTANT. I DON'T KNOW WHAT FRAMEWORK CAN HELP US DECIDE WHAT'S OFF THE LIST BUT SINCE IT'S A LIT OF THINGS TO BE CONSIDERED AND COULD BE LONGER I THINK THIS IS VERY VALUABLE. I'LL COME BACK TO ONE PROCESS ISSUE RAISED NANE E-MAIL I RECEIVED FROM SOMEONE WATCHING WHICH IS -- PARTICULARLY WHEN WE FRAME THINGS IN A QUESTION FORMAT BECAUSE THEY MAY WELL END UP BEING WRITTEN IN A QUESTION FORMAT IN THE FINAL DOCUMENT, DO WE WANT TO USE SOMETHING LIKE USE A TEACH-BACK OR ANOTHER PART OF THE PROCESS? THIS IS SUPPOSED TO BE ACCESSIBLE INFORMATION WE TALKED ABOUT AT THE END OF STUDY ASSESSING WHETHER PEOPLE UNDERSTOOD. SHOULD WE MOVE THAT UP FRONT? IS THIS SO KEY THAT BASICALLY PEOPLE SHOULD BE ABLE TO ARTICULATE THIS FOR THEMSELVES BEFORE MOVING FORWARD IN OTHER DISCUSSION? >> I'M JANE PROMITTE ER. WE HAVE KEY ELEMENTS AND BASIC ELEMENTS, ADDITIONAL ELEMENTS AND QUESTIONS THAT OVERLAP. I THINK THOUGH I LIKE THE QUESTIONS, I THINK THEY OVERLAP IN A DIFFERENT FORMAT THAN THE KEY INFORMATION ELEMENTS. AND I THINK IT GETS TOO CONFUSING BECAUSE PEOPLE ARE SO COMPLIANT ORIENTED I'M NOT SURE IT'S USEFUL TO PUT OUT TOO MANY DIFFERENT COMPETING THINGS. THOUGH IN THE COURSE OF DOING THIS WORK, I THINK IT'S GREAT THAT YOU'RE GENERATING A LOT OF TOOLS AND LOOKING AT DIFFERENT APPROACHES BUT I OFTEN SAY WHEN THE FDA SPEAKS, PEOPLE LISTEN AND SOMETIMES WHEN THE FDA DOESN'T SPEAK PEOPLE LISTEN. THEY TAKE SERIOUSLY. I THINK PEOPLE WILL HOLD WHATEVER THE COMMITTEE PUTS OUT. I WOULD CAUTIOUS AGAINST PUTTING THING OUT THAT MIGHT NOT BE READY FOR PRIME TIME OR BE TOO OVERLAPPING AND CONFUSING. >> WE ARE VERY MUCH IN THE THROW IT AGAINST THE WALL AND SEE IF IT STICKS STAGE. >> I LIKE THE QUESTION APPROACH BUT HAVE YOU TO BE CLEAR THAT THE ANSWER TO EVERY QUESTION MAY NOT BE KEY INFORMATION. THERE HAS TO BE THE ABILITY TO DISCRIMINATE AMONGST THE LIST. AND THERE'S THE FORMAT OF PRESENTATION OF THE KEY INFORMATION AND HOW IMPORTANT THAT'S GOING TO BE. I LIKE THE TABLE APPROACHES AND A DIFFERENT VIEW AND THERE'S A LOT OF ART TO PUTTING IT OUT IN A WAY THAT'S ACCESSIBLE. >> I WANT TO MAKE SURE TO GET THIS. TO PARTICIPATES IN THE DEVELOPMENT AND A DISCUSSION POINT? >> SURE. SO THE TABLE PROVIDING YOUR CHOICES WE PUT THE BRAND NAME OPTION GRID SO A CHOICE TABLE. THE LIST OF QUESTIONS COULD BE MADE AVAILABLE AS EXAMPLES WITHIN THE FIVE PREAMBLE GENERAL QUESTION TYPES OPPOSED TO A LIST OF QUESTIONS YOU MUST MEET EVERYTHING ON THE LIST AND THAT WOULD GIVE THE SUPPORT FOR THOSE USING IT TO DRAFT AND NOT NECESSARILY MAKE IT. YOU HAVE TO HAVE ANOTHER FIVE PAGES TO COVER THE QUESTION ON THE LIST THAT BECOMES ANOTHER COMPLIANCE POINT. ONE COMMENT I WANTED TO MAKE GOING BACK. I HEARD SEVERAL TIMES THE BEST-CASE, WORST-CASE QUESTIONS AND IT SOUNDS GOOD IN PRACTICE. I THINK IF YOU EMPHASIZE THAT TOO MUCH YOU'D GET THE WORST-CASE SCENARIO IS SOMETHING UNEXPECTED HAPPENS AND YOU DIE AND THE BEST CASE IS SOMETHING HAPPENS AND YOU SPONTANEOUSLY IMPROVE AND THERE'S NO PROBLEMS AND THOSE ARE BOILER PLATE PROBLEMS JUST AS USEFUL AS YOU MAY OR MAY NOT BENEFIT. IT MAY BE USEFUL IN SOME CONTEXT TO EXPRESS IT THAT WAY BUT IF ANSWER FOR EVERYONE I'M CONCERNED YOU'D END UP WITH A RESULT THAT IS DIFFERENT THAN WHAT WAS INTENDED. >> DAVID, CAN I SUGGEST WE DON'T WANT TO IMPLY THIS IS A CHECKLIST. ARE ANY OF THE TOOLS WE'RE MENTIONING ARE THEY PROPRIETARY OR COPYRIGHTED? >> EVEN IF YOU COPYRIGHTED THIS -- >> >> THE ENSCO GRID IS A COPYRIGHTED TOOL AND WE'D BE HAPPY TO WORK WITH YOU OR OTHERS IN SOME WAY IF THERE'S A COMMERCIAL APPLICATION WHERE IT WOULD BE MUTUALLY BENEFICIAL. >> WE HAVE THE SECONDARY PRESENTERS AND ARE YOU ON THE PHONE? >> ARE WE GOING BACK TO YOUR TOOL? I THINK I KNOW UNDERSTAND THE TABLE BUT NOT HOW THEY WORK TOGETHER? >> THAT'S BEHIND THE SCENES MAGIC. FILL THEM OUT AND SEND THEM TO ME AND A SUCK THE DATA IN AND PROCESS IT OUT THAT WAY. IT DOESN'T HAPPEN AUTOMATICALLY. IT DOES IF I RUN A SCRIPTED. -- SCRIPT. >> CAN YOU TALK ABOUT THE GROUPINGS. >> OKAY, I THINK YOU'RE TALKING ABOUT THE PDF GROUPING. LET ME GET IT UP. WHEN I GRAB THE OUTPUT THERE'S A NUMBER OF TRIAL DESIGNS THAT COME OUT WITH THE INFORMATION AND I KEY THOSE TOGETHER SO THOSE THE GROUPINGS. LET ME PULL IT UP. IF YOU LOOK AT GROUP ONE IT HAS THOSE STUDY TYPES AND GROUP TWO IS A DIFFERENT STUDY TYPE. SO THE STUDIES ONLY APPEAR IN ONE GROUP BUT STUDY TYPES THAT RESULT IN THE SAME REST KEY INFORMATION ARE SORTED BY THE SIZE OF THE GROUPS. >> THAT'S GENERATED FROM WHERE YOU PUT IT ON THE TABLE. >> I TAKE IT AND IT GENERATES IT. >> THE GROUPS, NOT THAT THEY'RE ACCIDENTAL BUT THEY HAVE ALL THE SAME Xs IN THEIR CATEGORIES ON THE SPREAD SHEET AND SO THAT'S WHAT PUTS THEM IN THE SAME GROUP? >> PROBABLY, BUT IT'S NOT -- YOU WOULD THINK GET IN THE SAME GROUP BY HAVING DIFFERENT Xs ON THE DIFFERENT SPREAD SHEETS. SO I'LL HAVE TO LOOK AT THAT BASICALLY THEY ARE, FOR THE MOST PART THINGS WITH SIMILAR Xs. >> OKAY. >> SO, DAVID YOU WERE ASKING IF DR. SCHWARTZ HAD A COMMENT. >> IF HE'S ON THE LINE. >> ARE YOU ON THE LINE? OKAY. >> WE'LL GET THE STUFF LATER. >> OKAY. WE THEN GET TO -- IS THERE ANYTHING MORE ON TOOLS? I THINK THAT WAS A GREAT DISCUSSION. >> I KNOW WE HAVE RESERVE TIME AS WELL AS TIME TO TALK ABOUT THIS AT A FUTURE MEETING BUT CAN WE RESERVE SOME OF THIS AFTER THE PRESENTATIONS THIS AFTERNOON. PARTICULARLY AS HOLLY WAS BRINGING UP THEP -- THE PDF GENERATE FROM YOUR TOOL I THINK WE'D HAVE A DIFFERENT PERSPECTIVE ON IT JUST AS WE WERE INFORMED BY THE EARLIER PRESENTATIONS WE'LL BE INFORMED MORE AS A RESULT OF THAT PRESENTATION -- >> I THINK ABSOLUTELY. I ALSO THINK WE SHOULD RESERVE SOME TIME TO THINK ABOUT STEPS FORWARD BOTH FOR THE SUBCOMMITTEE AND THE COMMITTEE BECAUSE THERE'S A LOT OF STUFF HERE AND WE NEED TO TALK ABOUT DIRECTION. >> I'LL MOVE TO QUESTION FIVE. 20 MINUTES LEFT TO LUNCH. QUESTION FIVE ASKED, ASSUMING RISK AND BENEFIT INFORMATION MUF MUST BE INCLUDED WHAT INFORMATION IS RELEVANT AND WHAT REASONABLY FORESEEABLE RISK AND BENEFICIAL BENEFITS SHOULD BE INCLUDE AND HOW SHOULD THEY BE DISCUSSED. HOW DO DIFFERENT STUDY DESIGNS WHAT POTENTIAL RISKS SHOULD BE INCLUDED IN THE KEY INFORMATION AND HOW SUCH RISKS AND BENEFITS SHOULD BE DESCRIBED. SO THIS ANSWER DIVES A LITTLE DEEPER IN THE WEEDS THAN THE OTHERS BECAUSE IT'S A MORE SPECIFIC QUESTION. FOR SAYING RISK AND BENEFIT SHOULD BE INCLUDE AND WE DON'T THINK IT'S A VALID ASSUMPTION. SOMETIMES THERE'S A MINIMAL RISK STUDY WHERE RISKS AND BENEFITS WON'T BE KEY. THAT'S HOW WE STARTED OFF AND WE SAID AT OTHER TIME IT MAY WELL BE. THEN IN LINES 410 DOWN, WE HAD SOME KIND OF GROUP DISCUSSIONS ABOUT WHAT WOULD BE THE CONSIDERATIONS RELEVANT AND STRATEGIES TO BE USED TO DETERMINE WHICH RISKS AND BENEFITS SHOULD BE INCLUDED. SO 414 WE SAID ONE POSSIBLE CONSIDERATION IS THE RESEARCH AND BENEFITS VARY FROM CLINICAL TRIAL. IF THEY'RE DISTINCTLY DIFFERENT PERHAPS THEY'RE KEY. 418 TO 419 IF RISKS AND POTENTIAL BENEFITS ARE DIFFERENT THAN STANDARD CARE [INAUDIBLE]. 421 TO 424 IF THE RISKS AND POTENTIAL BENEFITS THE SUBJECT WOULD PROBABLY USE THEM WITHOUT MORE INFORMATION AS CRITERIA TO DECIDE TO PARTICIPATE -- YOU KNOW, THIS SAY -- IS A RISKY TRIAL AND [INAUDIBLE] AND THE MOST RISK AND SEVERITY WOULD BE EXCEPTIONAL. STARTING ON 426 WE SAID DISCOMFORT AND INCONVENIENCES MAY BE RISK. FOR EXAMPLE, EXPOSURE TO SUNLIGHT FOR FOUR MONTHS OR SHOULD AVOID ALL SEXUAL CONTACT FOR FOUR MONTHS. THOSE AREN'T RISKS, THEY'RE REALLY DISCOMFORTS BUT REALLY ADDITIONAL INFORMATION HOW THIS IS GOING TO AFFECT YOUR LIFE. AND 431 TO 435, WE SAID AND YOU MAY OR MAY NOT BENEFIT AND THEN WE SAID IN THE NEXT PART OF THE QUESTION IS HOW SHOULD RISKS AND BENEFITS BE DISCUSSED AS KEY INFORMATION. WE THOUGHT A PRO AND CON FRAMEWORK WAS THE BEST WAY TO DISCUSS THE INFORMATION AND SEVERAL COMMITTEE MEMBERS THOUGHT IT WAS IMPORTANT IN THE KEY INFORMATION SECTIONS. AND THE LAST PART OF QUESTION FIVE IS THE DIFFERENT STUDY DESIGNS AND WE SAID THERE'S TOO MUCH VARYING. SO COMMENTS ON THAT SECTION. SANDRA. >> WHEN YOU SUGGEST THE PROS AND CONS FRAMEWORK AND WHY YOU MAY OR MAY NOT WANT TO DO THIS OR LITERALLY USING THE WORDS OR POSING IT AS THE WHY WOULD YOU WANT TO OR NOT WANT TO? >> I THINK BOTH WERE ARTICULATED AND WE DIDN'T SEPARATE THEM OUT. IT'S A GREAT POINT. IT'S AN UNDERLYING THEME THAT CAME UP A LOT. >> AND WHEN WE REVISED THAT IT MAKE THAT CLEAR AND BE THE I HAVE A QUESTION IN THE BEGINNING ABOUT A MINIMAL RISK STUDY AND GIVEN THIS IS IN THE CONTEXT OF A CLINICAL TRIAL, I WASN'T COMING UP WITH AN EXAMPLE UNLESS YOU'RE THINKING OF DOING A COMPARATIVE STUDY WITH TWO EXISTING STANDARD TREATMENTS OR SOMETHING >> A GOLD STANDARD. IT COULD BE A MINOR DEVICE -- >> IT MAY BE HELPFUL TO GIVE A COUPLE EXAMPLES. LIKE I TRIPPED OVER THAT FOR A MOMENT AND JUST TO BE CLEAR ABOUT THAT AND THERE ARE PIECES IN THIS I REALLY APPRECIATE IT AND PARTICULARLY THE COMMENT THAT THE RISKS AND POTENTIAL BENEFITS PRESENTED IN KEY INFORMATION SHOULD NOT BE JUST A SHORT VERSION. I EXPRESSED MY CONCERN IS THE NEW REQUIREMENT COULD BE TREATED AND IT'S ARTICULATED IN THE DOCUMENT IT WOULD BE TREATED LIKE THE BOILER PLATE WE'RE USED TO AND THE EMPHASIS ON THAT THAT IT'S NOT THAT IS CRITICAL. SO THANK YOU FOR MAKING THAT EMPHASIS. >> DO YOU THINK THERE'D BE VALUE IN HEARING FROM JANE FIRST BEFORE YOU CONTINUE WITH THE DOCUMENT? I'M NOT SAYING WE SHOULD WITH A LOT UNTIL AFTER LUNCH -- I THINK IT'S A GOOD IDEA TO HEAR ALL THE EXPERT ADVISORS. >> I THINK THAT WAS STEVEN'S POINT IS THAT WE'LL CIRCLE THAT. WE ONLY HAVE ONE QUESTION LEFT. SANDRA. >> I DIDN'T UNDERSTAND THE FIRST BULLET POINT. I COULDN'T OPERATIONALIZE THE FIRST BULLET POINT. >> SAY IT'S NIH FUNDED AND WANT TO LOOK AT THE EFFECTIVENESS AND JOINING THE RESEARCH WILL NOT CHANGE THE RISK PROFILE MUCH FROM STANDARD OF CARE, OPPOSED TO A STUDY WHERE YOUR RANDOMIZED CARE WITH A HIGHLY TOXIC DRUG WILL LITTLE [INAUDIBLE]. >> IT ASSUMES YOU'RE GETTING THE BENEFIT AND RISK INFORMATION IN STANDARD CLINICAL CARE WHICH IS OFTEN NOT THE CASE. SO IF THE TRIAL IS COMPARING TWO STANDARD TREATMENTS AND WE'RE NOT GIVING PEOPLE INFORMATION ABOUT THE BENEFITS AND RISKS COMPARING THOSE TWO BUT WE'RE NOW ASKING THEM TO ENROLL IN A TRIAL WHERE THEY MAY BE RANDOMIZED TO THE TWO STANDARD TREATMENTS, IT WOULD BE GOOD CLINICAL CARE THEY KNOW THE BENEFITS AND RISKS AND IF THEY'RE GOING TO AGREE TO HAVE A COMPUTER DECIDE WHICH ONE THEY GET KNOWING WHAT THE TRADE-OFFS ARE BETWEEN THE TWO AND MAKING THE DECISION WOULD BE HELPFUL. I THINK BECAUSE WE ARE NOT ALWAYS GIVING KEY INFORMATION FOR STANDARD CLINICAL CARE, IF WE ARE INCLUDING CLINICAL CARE IN THE RESEARCH, WE HAVE TO PROVIDE THE KEY INFORMATION AND INFORMED CONSENT FOR THE STANDARD CLINICAL CARE WITH IT AND THEY COULD NOT BE THE SAME UNLESS YOU THINK OF BENEFITS BROADLY AND ALTRUISTIC BENEFITS AND SO FORTH AND RISKS BROADLY AND THE DISCOMFORTS OR COSTS. THOSE CAN ALSO BE DUPLICATIVE INFORMATION. THAT COULD BE USEFUL IF YOU WANT TO REINFORCE THE CONCEPTS OR IT COULD BE CUMBERSOME IF IT'S ADDING MORE TO THE INFORMATION LOAD SO JUST ANOTHER CONSIDERATION. >> IT'S WHERE IT'S KEY INFORMATION. AND WHEN YOU'RE TRYING TO MAKE A DECISION BETWEEN THE CHOICES IF YOU'RE CHOOSING TO PARTICIPATE IN THE RESEARCH, THE RISKS AND BENEFITS OF WHAT WOULD HAPPEN IN THAT RESEARCH WOULD STILL -- I WOULD THINK, BE KEY INFORMATION. IT'S A QUESTION OF NOT NECESSARILY EVERY POSSIBLE RISK. THAT'S ANOTHER PART OF THIS OVERALL QUESTION. I'M JUST SAYING THE FACT THE RISK WOULD OCCUR IN CLINICAL CARE IF THAT'S PART OF THE INTERVENTION BEING STUDIED. I THINK THAT WOULD BE KEY INFORMATION TO KNOW ABOUT. >> ACTUALLY, THIS IS AN IMPORTANT POINT BECAUSE IT'S ABOUT THE RELATIONSHIP BETWEEN KEY INFORMATION AND THE REST OF CONSENT AND THERE'S A LOT OF WAYS TO ARGUE ABOUT COMPARATIVE EFFECTIVENESS RESEARCH AND ONE WAY TO SAY THIS IS THE POTENTIAL BENEFITS AND RISKS OF HARM ARE REALLY QUITE SIMILAR IN BOTH ARM OF THIS TRIAL. WE HAVE A LOT OF DETAIL ABOUT THAT AND THE REST OF THE CONSENT FORM BUT WHAT'S KEY INFORMATION IS THE DECISION ABOUT WHICH ARM YOU GET IS NOT CHOSEN BY THIS IS WHAT THIS INSTITUTION ALWAYS DOES OR THIS IS WHAT YOUR DOCTOR PREFERS BUT RANDOMLY. THAT'S REALLY WHAT'S BEHIND THIS FIRST BULLET POINT. >> I WAS TRYING TO GET SOMETHING IN HERE AT AN EARLIER POINT ABOUT THE STUDY DESIGN MIGHT ACTUALLY BE IMPORTANT HERE BUT IT WASN'T PART OF THE RISKS AND BENEFITS QUESTION BUT I THINK WE CAN ACTUALLY REFRAIN THAT FIRST BULLET TO MAKE CLEAR WHAT IS KEY AND CONNECT IT TO THE REST OF THE CONSENT FORM AS WELL. >> I MAY NOT HAVE STATED CLEARLY IN THE BEGINNING BUT I'M VERY OPEN TO CONTRIBUTIONS WITH MEMBERS. HAVE AT IT TO MAKE IT BETTER. >> WHILE RECOGNIZING WE DON'T ALWAYS DO AS WELL IN CLINICAL CARE CONSENT AS WE PROBABLY SHOULD, I DO THINK IT'S IMPORTANT FOR THE KEY INFORMATION TO EMPHASIZE THE DELTA BETWEEN WHAT WOULD HAPPEN TO YOU IN RESEARCH VERSUS WHAT WOULD HAPPEN TO YOU IN CLINICAL CARE. AND YOU CAN STILL PROVIDE ALL OF THAT INFORMATION IN THE MAIN BODY OF THE CONSENT FORM BUT WHAT WE WANT TO FOCUS PEOPLE -- WHAT I THINK WE SHOULD FOCUS PEOPLE IN ON IS HOW IS THIS FUNDAMENTALLY DIFFERENT FROM WHAT YOU WOULD BE EXPOSED TO OR EXPECT IN THE CONTEMPT OUTSIDE OF RESEARCH. >> THE LAST QUESTION. [READING QUESTION] OUR RESPONSE WAS, YOU DON'T HAVE TO REPEAT EVERYTHING. YOU CAN REPEAT THINGS. THIS IS OUR WAFFLE RESPONSE. VERY OPEN TO COMMENTS. WE HAVE TO CUT IT BOTH WAYS AND SAY IT DEPENDS. >> ONCE SOMETHING MAKES IT WAY TO KEY INFORMATION IT DOESN'T NEED TO APPEAR IN THE MAIN BODY OF THE DOCUMENT. IT CAN MAKE THE MAIN BODY IN INCOMPREHENSIBLE AND IT DOESN'T GIVE US A RULE THAT SAYS IT ALWAYS MUST BE IN BOTH PLACES. IF IT'S RELEVANT TO COMPREHENSION IN THE MAIN BODY AND RISKS BEING MISREAD IT SHOULD BE IN BOTH PLACES. THE WORRY IS THAT PEOPLE WILL APPROPRIATELY TRY TO USE HEADINGS IN THE CONSENT FORM AND SKIM THROUGH VARIOUS THINGS AND IF THEY SEE A SECTION ON RISKS THEY MIGHT EXPECT ALL THE RISKS TO BE LISTED THERE. EVEN THOUGH IT WAS LISTED SOMEWHERE ELSE. IT'S DIFFICULT TO REMEMBER WHAT HE READ IN THE LONG DOCUMENT. SO THAT'S JUST A LITTLE BIT MORE BACKGROUND THAN WHAT WE DISCUSSED. >> THIS PARAGRAPH IS HARD TO READ. YOU MAY WANT TO SIMPLY RERIGHT THE PARAGRAPH TO SAY IF YOU NEED TO REPEAT THE INFORMATION TO MAKE SECTIONS UNDERSTANDABLE, THEN DO THAT. >> THIS IS HOW THE FORMAT OR MEDIUM USED MEANS A LOT BECAUSE IF YOU'RE USING ELECTRONIC CONSENT AND CAN HOVER OVER OTHER AREAS OR JUMP AROUND IT MAKES THESE THINGS EASIER TO DEAL WITH. >> I THINK THE FRAMING AND PRESENTATION, THE WHOLE POINT IS IT'S DIFFERENT. IF YOU HAVE A RISK LIST OR BENEFIT LIST ON THE REST OF BENEFIT WHICH IS SUPPOSED TO BE REWRITTEN TO MAKE IT MORE COMPREHENSIBLE BUT STILL TO TAKE THINGS OUT SIMPLY BECAUSE THEY WERE MENTIONED IN A DIFFERENT IT COULD BE MISLEAD. I THINK IT WOULD MAKE IT INCONSISTENT AND JUST AND WE'VE HAD A LOT OF BACK AND FORTH CONDITION SESSION AND THE ANALOGY I HAVE IN MIND IS THAT BECAUSE YOU HAD WRITTEN IN ABSTRACT YOU WOULDN'T EXTRACT THOSE SENTENCES FROM THE PAPER BECAUSE IT WOULDN'T MAKE SENSE TO DO THAT. IT'S APPROPRIATE TO DO THAT IN BOTH PLACES. >> FEEL FREE TO BRING YOUR LUNCH BACK HERE IF YOU WANT BUT I THINK WE'RE GOING TO HAVE ANOTHER PANEL AND WE WILL RECONVENE AT 1:00. IF YOU'RE SHORT OF TIME JUST BRING YOUR FOOD DOWN. LET'S RECONVENE. AND I WOULD INVITE OUR PANELISTS FOR THE NEXT SESSION TO COME UP TO THE FRONT. AND I AM GOING TO INTRODUCE YOU BY NAME. BUT IF YOU COULD JUST TAKE A MOMENT AND GIVE A BIT OF CONTEXT AND BACKGROUND, THAT WOULD BE HELPFUL, I THINK AS WE LISTEN TO REMARKS. SO THIS NEXT PANEL WHICH IS PATIENT REPRESENTATIVE'S PERSPECTIVES ON KEY INFORMATION IN INFORMED CONSENT IS DANA CNINGOS, AND JANE PEARE, LMUTTER AND RICHARD KNIGHT, VICE PRESIDENT AND CHAIR PUBLIC POLICY COMMITTEE AMERICAN ASSOCIATION OF KIDSNY PATIENTS. DIANA, WE'LL GO LEFT TO RIGHT AS YOU ARE SITTING ACROSS THE PANEL WITH INTRODUCTIONS AND THEN, YEAH. >> I'M UNAFFILIATED, NONSCIENTIST MEMBER OF 2 IRBs,OT USC SOUTHERN CALIFORNIA IRB SINCE 2007. I REVIEW CLINICAL TRIALS ON A SCIENTIFIC REVIEW COMMITTEE BEFORE THAT AND AN OPPORTUNITY TO LOOK AT CONSENTS BEFORE THEY MADE IT THE IRB. I'M A CANCER SURVIVOR WHO HAS BEEN OBSERVING THE CONDUCT OF RESEARCH OVER THE PAST 24 YEARS. AND AT LEAST 12 OF THOSE YEARS ENGAGED WITH RESEARCHERS ON FUNDED STUDIES. I'M A PATIENT NAVIGATOR HELPING NEWLY DIAGNOSED PATIENTS OR PEOPLE WHO ARE NEWLY DIAGNOSED WITH ADVANCED DISEASE WITH THEIR TREATMENT OR CLINICAL TRIAL DECISION MAKING AND LAST, ALSO AN ADVOCATE AT NCI AND VARIOUS STEERING COMMITTEES THAT ENCLUED INVESTIGATIONAL DRUGS, WE CAN MAKE DECISIONS ABOUT WHAT AGENTS TO BRING INTO THE EARLY PHASE TRIAL PORTFOLIO, NCI AND CORE CORRELATIVE SCIENCE COMMITTEE WHICH REVIEWS REQUESTS FOR USE OF BIOSPECIMENS AND RESEARCHED USE OF BIOPESMENS FROM THE COOPERATIVE GROUP CLINICAL TRIALS. >> SO I'M JANE PERLMUTTER AND A LONG-TERM CANCER SURVIVOR, LONGER THAN DIANA AND ALSO A LONG-TERM ADMIRER AND FRIEND OF DIANA, I CAN SAY. WE'VE KNOWN EACH OTHER FOR QUITE A WHILE DISP WE OVERLAP IN A LOT OF THESE THINGS. MY SECOND SLIDE ACTUALLY WAS, WHO AM --I? I'M HERE BECAUSE I'M A CANCER SURVIVOR AND THAT WAS VERY TRAUMATIC IN MY LIFE AND THAT INFLUENCED A LOT OF THINGS I DO, AT THE TIME I WAS A YOUNG 30 YEAR-OLD ALMOST AND WAS A WORK AHOLDING COMPANYIC BUT I INCREASINGLY DO MORE AND MORE ADVOCACY AND AM BASICALLY RETIRED NOW AND SPEND PRETTY MUCH FULL-TIME HAVING FUN DOING ADVOCACY. ALTHOUGH THIS TAN IS FROM THE GALAPP A LOGOS THE LAST 2 WEEKS. IN CASE YOU WERE INTERESTED BUT MY BACKGROUND IN ACADEMIC EXPERIMENTAL PSYCHOLOGIST AND I USED TO TEACH STATISTICS AND THAT INFORMS A LOT OF WHAT DO. I WORKED IN ACADEMICS, I COOPERATE R&D AND OTHER THINGS AND I AM ESPECIALLY INTERESTED IN INNOVATIVE CLINICAL TRIAL DESLEEP APNEA AND OBESITY SIGN AND INVOLVED WITH WHAT I DO IS THE I SPY TRAIL AND THE TAPER TRIAL WHICH YOU MAY OR MAY NOT KNOW ABOUT. I AM HAPPY TO TALK ABOUT THAT OFFLINE. I THINK I'M INVITED HERE PRIMARILY, 1 OF THE THINGS I DO IS I'VE BEEN INVOLVED WITH CITY, THE CLINICAL TRIALS TRANSFORMATION INITIATIVE SINCE FIST BEGINNING, I WAS THE FIRST ADVOCATE ON THIS STEERING COMMITTEE AND CO LED A PROJECT ON INFORMED CONSENT. WHICH HAS OVERLAP AND EFFECT TO THIS GROUP AND I KNOW A NUMBER OF YOU FROM THERE SO THAT IS WHERE A NUMBER OF MY COMMENTS >> GOOD AFTERNOON. MY NAME IS RICHAR KNIGHT WITH THE AMERICAN ASSOCIATION OF KIDNEY PATIENTS. I HAVE BEEN DEALING WITH CHRONIC KIDNEY DISEASE SINCE 1996, SPENT A COUPLE YEARS ON DIALYSIS AND NOW I'M ABOUT 11 YEARS OUT O A TRANSPLANT. BASED ON THE EXPERIENCE I WENT THROUGH, I THOUGHT THERE COULD BE A BETTER WAY. SO I HAD BEEN TEACHING GRADUATE AND UNDERGRADUATE COURSES AND BUSINESS AND POLICY AREAS FOR THE LAST 30 + YEARS AND AS I OBSERVED WHAT WAS GOING ON IN THE INDUSTRY TO SOME OF MY PATIENTS, FROM MY COLLEAGUES WHO WERE IN SITUATIONS WHERE THEY COULDN'T NECESSARILY UNDERSTAND, ARTICULATE OR SPEAK WELL FOR THEMSELVES, I GOT MORE AND MORE INVOLVED IN THE AREA OF CLINICAL TRIALS AND CERTAINLY MUCH OF THE WORK THAT I DO IS IN THE AREA OF ADVOCACY. I WILL STOP THERE BECAUSE I COVER A LOT OF THAT IN THE SLIDES THAT I PROVIDE. I THINK THAT IT'S IMPORTANT TO GIVE YOU CONTEXT. THE PERSON OUT HERE THAT I DEAL WITH RENAL DISEASE, KIDNEY DISEASE, BUT MY FAWRLGT PASSED OF AND BOTH OR 3 OF THEM BY THE TIME THEY WERE MY AGE--I HAD A BIRTHDAY YESTERDAY, I WON'T GET INTO THE SPECIFICS ON THAT AND VERY INTERESTING IF HE HAD BETTER CARE, MY FATHER WOULD HAVE LIVED MUCH LONGER SO I DEAL FROM THE PERSPECTIVE OF TRYING TO SPEAK FOR SOME OF THOSE BHO DON'T UNDERSTAND. WORK WITH A LOT OF RESEARCHERS WHO WEREN'T USED TO DEALING WITH PAIBTS AND FOR ME IT'S ABOUT EDUCATION FROM ALL SIDES. SO I WILL STOP THERE AND LOOK FORWARD TO THE PRESENTATIONS AND LOOK FORWARD TO ENGAGING EVERYONE HERE. >> THANK YOU. DIANA WOULD YOU LIKE TO START. >> I'M SORRY, I DON'T HAVE SLIDES. OKAY, SORRY ABOUT THAT. JUST TO LET YOU KNOW I DON'T HAVE ANY SLIDES AND I THINK THAT WILL GO PRETTY QUICKLY. YOU KNOW SO WE'VE HEARD A LOT ABOUT HOW INFORMED CONSENTS HAVE BECOME REPOSITORIES FOR LEGAL INFORMATION WHETHER IT'S INDUSTRY OR YOU KNOW AGENCIES COMPLIANCE DEPARTMENTS, AND SOMETIMES IT REALLY SEEMS AS IF EVERYONE IS REPRESENTED BUT FOR THE PATIENT. I FREQUENTLY INTERACT WITH CLINICAL RESEARCHERS WHO SAY, YOU KNOW, GET--WHAT YOU ARE YOU SAYING? EVERYTHING I DO IS FOR PATIENTS AND I'M SURE THAT'S TRUE FOR MANY OF YOU IN THIS ROOM. BUT THEN I WONDER, YOU KNOW WHY DO CONSENTS READ THE WAY THEY DO? AND HOW DO WE MOUNT AN INTERVENTION? ,. YOU KNOW, TO ME AGAINST THIS PROBLEM? TO ME, THINK WHAT YOU THINK BUT THIS EASY TO READ, 1-PAGE SUMMARY IS PART OF THIS INTERVENTION. SO FOR MY COLLEAGUES HERE, THE PRESSURE'S ON. I SUPPORT IT NOT BECAUSE I WANT TO COMPLICATE AN ALREADY OVERBURDENED IRB INFRASTRUCTURE, I SUPPORT IT BECAUSE IT COULD MEAN, LET'S HOPE IT MEANS CLARITY FOR POTENTIAL STUDY PARTICIPANTS WHO ARE AT A POINT IN THEIR LIVES WHEN ATTENTION SPANS ARE REALLY MAXED OUT. BUSY, IMPORTANT PEOPLE, YOU KNOW RESPECTED PEOPLE, ALL THE TIME ARE EQUIPPED WITH EXECUTIVE SUMMARIES, YOU KNOW HOW OFTEN DO YOU PICK UP THE EXECUTIVE SUMMARY. I KNOW I GET--IF I GET AN IOM REPORT OR NATIONAL AKD--SALLY ME OF--AKD--SALLY ME OF MEDICINE, I READ THE EXECUTIVE SUMMARY. SO I DON'T REALLY GET WHY THIS IS SO COMPLICATED. AND I UNDERSTAND WITH RESPECT TO THE PEOPLE HERE WORKING WITH SACK REP, SACHRP, THIS HAS TO DO WITH THE INCREDIBLE ENORMITY OF RESEARCH THAT YOU'RE TRYING TO PROVIDE GUIDANCE THAT APPLIES TO A LOT OF SITUATIONS BUT TO ME, THIS IS REALLY SOMEWHAT SIMPLE. AND I KNOW SOME OF THIS COMPLEXITY HAS TO DO WITH THE FACT THAT WE HAVE A CRITICAL MASS OF ETHICISTS IN THE ROOM SO WE CAN'T OVERLOOK THAT. >> [INDISCERNIBLE]. >> AND LAWYERS, RIGHT. SO I HANDED OUT--I WON'T GO OVER THIS NOW, BUT I DID HAND OUT A SHEET WITH THE ELEMENTS THAT I THINK ARE IMPORTANT AND AS--YOU KNOW AS SOMEBODY--I REMEMBER TALKING TO A DOCTOR WHEN I WAS DIAGNOSED BECAUSE I THOUGHT, OH I HAD CANCER, I SHOULD ASK ABOUT A CLINICAL TRIAL, I READ THAT SOMEWHERE AND YOU KNOW THE DOCTOR, YOU DON'T WANT TO DO THAT, THAT'S REALLY BAD NEWS. AND NOW WHEN I THINK BACK ON IT, THERE WERE SOME REALLY INTERESTING TRIALS IN LOS ANGELES AT THE TIME. I WISH I HAD TAKEN PART. BUT ANYWAY, SO THIS LOGIC MODEL IS DESIGNED TO HELP REGULATORY PROFESSIONALS IN THEIR EFFORTS TO COMPOSE THIS DOCUMENT. PATIENTS DO NOT HAVE A LOGIC MODEL AND AS AN ADVOCATE AND SOMEBODY WHO WORK WIDE ADVOCACY ORGANIZATIONS OVER THE YEARS, YOU KNOW WE REALLY DO TRY TO GET TO PATIENTS AT THIS CRITICAL TIME IN THEIR LIVES AND EARLY ON, WHEN THE FIRST SEEING DOCTORS, THEY'RE OFTEN NOT AT ALL PLUGGED IN WITH ADVOCACY AND I DON'T KNOW IF THAT'S YOUR IMPRESSION, OR RICHARD THAT'S YOUR IMPRESSION, RIGHT? IT TAKES A WHILE FOR YOU TO FIND THEM AND THEM TO FIND YOU. YEAH. AND THEY'RE STILL IN THIS STAGE, FORGIVE ME, IN ADVANCE FOR WHAT I AM GOING TO SAY BUT THEY STILL THINK THAT THE HEALTHCARE SYSTEM IS ORGANIZED TO THEIR ADVANTAGE RIGHT, WHICH IT'S NOT. THEY'RE STILL THINKING THEIR PHYSICIAN IS ACTING IN THEIR BEST INTEREST AND I'M NOT SAYING PHYSICIANS DON'T, I'M SAYING THERE ARE A LOT OF COMPETING BIASES AND AND INTEREST THAT CAN INFLUENCE DOCTORS. SO WE ARE IN, WE ADVOCATES ARE IN THE SECOND TIER WHICH IS WHY IT'S SO IMPORTANT FOR US TO GET THIS RIGHT. SO I'M MUCH ENCOURAGED BY RECENT PROGRESS BUT MY MEMORY IS LONG. LIKE I REMEMBER GOING THROUGH THIS AMAZING COURSE THAT'S OFFERED BY THE NATIONAL BREAST CANCER COALITION, I MET JANE AT 1 OF THE COURSES AND THINKING, OKAY, I'M GOING TO GO BACK TO MY COMMUNITY AND I WILL HAVE AN CLINICAL TRIAL EDUCATIONAL SERIES, YOU KNOW. I WANT TO IMPROVE YOU KNOW HEALTH LITERACY, RESEARCH LITERACY AND I CONTACTED ALL THE MAJOR EN--STRATEGIES TUITIONS IN THE AREA INCLUDING 1 I HAD PARTICULARLY INTERESTING TRIALS AND IT WAS LIKE A SECRET CLUB. IT WAS LIKE NOBODY WAS INTERESTED IN TALKING ABOUT THEIR CLINICAL TRIALS. IT WAS LIKE WHY ARE YOU--WHY ARE YOU ASKING? AND ST. JOHNS HAS THE JOHN WAYNE CANCER EN--STRATEGIESITUTE WHICH IS AT THE--INSTITUTE AT THE TIME WAS FUNDED BY THE JOHN WAYNE FAMILY OR JOHN WAYNE'S FAMILY AND THEY'RE LIKE, OH NO WE'RE NOT COMFORTABLE WITH THIS. NOBODY WAS COMFORTABLE WITH PERMITTING INFORMATION ABOUT CLINIAL TRIALS AND LIKEWISE, YOU KNOW, THE DAYS BEFORE CLINICAL TRIALS.GOV ARE NOT THAT LONG AGO. WHAT AN INCREDIBLE RESOURCE THAT IS FOR US NOW. YOU KNOW AND IT'S GETTING BETTER. I ALSO REMEMBER AFTER THE LAUNCH OF CLINICAL TRIALS.GOV THAT A LOT OF INVESTIGATORS WERE VERY RETICENT TO PUT ANYTHING IN THERE. IT WAS LIKE TWISTING ARMS TO GET INSTITUTIONS, INVESTIGATORS TO, YOU KNOW INVEST IN THIS THING. AND IT WASN'T UNTIL IT BECAME A REQUIREMENT FOR PUBLICATION THAT YOU KNOW IT REALLY CAUGHT THE ATTENTION OF A RESEARCHERS, THIS IS UNFORTUNATELY WHAT WE HAVE TO DO AGAIN AND AGAIN AND IT HAS ALWAYS AMUSED ME, HOW MUCH ALTRUISM IS EXPECTED FROM PATIENTS, YOU KNOW AT A TIME WHEN THEY'RE VERY SICK AND NOW DIFFICULT IT IS TO MOBILIZE, YOU KNOW PAID PROFESSIONALS IN HEALTHCARE AND YOU KNOW THE OTHER RELEVANT SECTORS TO ACT IN THE BEST INTEREST OF THE HEALTHCARE SYSTEM. YOU KNOW--OKAY, SO WE'RE HERE WITH HHS, AND WE THINK, YOU KNOW THERE'S A LONG, LONG LIST OF THESE THINGS, HHS HAVING TO WITHHOLD PATIENT TO GET ANY MOVEMENT ON THE REDUCTION OF MEDICAL ERRORS. HAVING TO PASS A BILL, YOU KNOW THE EMERGENCY MEDICAL TREATMENT ACT AND LABOR ACT TO FORCE HOSPITALS TO TAKE IN SICK PEOPLE. I MEAN, YOU WOULD THINK WE HAVE MORE CIVILITYS IN OUR LIVES BUT WE DON'T. WE TEND TO HAVE TO REALLY USE A HAMMER TO MAKE THINGS BELTER FOR PATIENTS. --BETTER FOR PATIENTS. AND YOU KNOW THIS REWORKING OF OUR NATIONAL CLENICAL TRIAL SYSTEM WHICH AGAIN IS THIS AMAZING RESOURCE--IT'S A MARKED IMPROVEMENT OVER WHAT PREVIOUSLY EXISTED. THERE WERE SEVERAL EN--STRATEGIESITUTE OF MEDICINE REPORTS--INSTITUTE OF MEDICINE REPORTS THAT TALKED ABOUT HOW THERE WAS LITTLE CONCERN ABOUT DID YOU PLICAATIVE TRIALS AND TRIALS THAT WERE TAKING VERY, VERY LONG TO ACCRUE. I CAN RECALL ALTHOUGH THESE WERE NOT NCI STUDIES BUT I CAN RECALL PHASE 1 STUDIES TAKING 5-10 YEARS. SO I KNOW WE'RE HERE TO TALK ABOUT INFORMED CONSENT BUT I'M TRYING TO GIVE YOU BACKGROUND WHAT WE'RE UP AGAINST IN THE RESEARCH COMMUNITY AS PATIENTS AND AS ADVOCATES. YOU KNOW I WOULD LIKE TO THINK AT TODAY'S RATE OF SCIENTIFIC DISCOVERY, THAT YOU KNOW THIS--YOU KNOW WE WOULD--THIS WOULDN'T HAVE HAPPENED BUT I DON'T KNOW. I THINK HAD THESE REPORTS NOT BEEN ISSUED, WE MIGHT STILL BE WAITING AROUND FOR THESE NEW CHANGES AND NOW INNOVATIONS. WHEN THERE'S A QUID PRO QUO, YOU CAN FIND REALLY DRAMATIC RESULTS AND AS AN EXAMPLE, I JUST WANT TO CITE NCI'S MATCH TRIAL WHICH SET A GOAL OF SEQUENCING 6000 TUMORS AND COMPLETED IT 2 YEARS EARLIER THAN EXPECTED. A REAL SUCCESS STORY. NOW SO SOME OF THIS HAD TO DO WITH THE HUGE NUMBER OF CENTERS THAT WERE PARTICIPATING IN THE STUDY THAT OPENED THE STUDY BUT SOME OF IT HAD TO DO WITH TRIALISTS, HAVING SOMETHING TO OFFER THEIR PATIENTS AND ALSO PATIENTS BEING EXCITED TO PARTICIPATE IN AN INNOVATIVE STUDY THAT GAVE THEM SOMETHING TANGIBLE. YOU KNOW SOMETHING MORE THAN THAT FEEL GOOD ALTRUISM TO CONTRIBUTING TO MARVIN MUSCANIS BENEFIT IN THE FUTURE. I HAD A BOSS NAMED NOREEN FRAZIER WHO HAD A WOMEN'S CANCER RESEARCH FOUNDATION AND SHE HAD--SHE HAD BEEN THROUGH EVERY TREATMENT IN THE BOOK FOR BREAST CANCER AND FOUND HER WAY ON TO A PHASE 1 TRIAL THAT KEPT HER CANCER STABLE FOR 2 YEARS AND I THOWLT SHE WAS CONFUSED, I THOUGHT MAYBE ALL THIS TREATMENT HAD ADDLED HERE SOMEHOW, YOU KNOW A PHASE 1, COME ON, THIS CAN'T BE POSSIBLE. BUT INDEED, LI LILLY--ELI LILLY HAD DESIGNED--[RECORDING INTERRUPTING MEETING ] --SO WE WENT TO LILLY, MET WITH THE DRUG DEVELOPMENT TEAM, SHE WAS INCREDIBLY EXCITED TO MEET THEM AND THEY HER BECAUSE THEY HAD LITTLE EXPOSURE TO THE PATIENTS THAT RECEIVED THEIR DRUG AND IT WAS ABSOLUTELY FASCINATING THAT THIS REALLY WAS INDEED A PHASE 1 ADAPTIVE DESIGN TRIAL AND WE ARE SEEING MORE OF THESE NOW, WE ARE SEEING THESE--JONATHAN WAS TALKING ABOUT THESE 3 PLUS 3 TRADITIONAL PHASE 1S WHERE THE FIRST SET OF COHORT OF PATIENTS GETTING THE DRUG GET LIKE 1 10th OF A DOSE THAT'S TOXIC TO A MOUSE AND YOU KNOW YOU WORK UP FROM THERE. IT MEANS A LOT OF PEOPLE ARE GETTING SUBTHERAPEUTIC DOSES AND I KNOW THE ETHICS COMMUNITY TALKS ABOUT THERAPEUTIC MISCONCEPTION. YOU KNOW, I'M SURPRISED THAT THERE ISN'T A BIGGER LITERATURE FROM THE ETHIC'S COMMUNITY ABOUT THE--YOU KNOW THE LACK OF ETHICS GIVING SUBTHERAPEUTIC DOSES TO PATIENTS IN THESE STUDIES. THAT WOULD BE MUCH HIGHER ON MY LIST. SO YEAH, WE HAVE THESE NEW METHODS, CONTINUOUS ACCELERATION METHOD, TITRATION METHOD, INTRA PATIENT DOSE ESCALATION. AND WE HAVE--OKAY, SO IT'S TRUE, THIS OLD 3 PLUS 3 IS STILL THE MAIN STAY OF A LOT OF PHASE 1 PROGRAMS BUT WE HAVE SOME REALLY MOTIVATEED STATISTICIANS WHO ARE TRYING TO GET THE WORD OUT THERE ABOUT THESE NEW ADAPTIVE DESIGN STUDIES. SO THESE ARE--OH YEAH AND I ALSO WANT TO MENTION THAT THESE--ON 1 END YOU HAVE A SUBTHERAPEUTIC DOSE FOR THESE PHASE 1S AND THEN THEY EVENTUALLY GO TO--THEY REACH A DOSE LIMITING TOXICITY. THEY TAKE THE CANCER DRUG IS DOSING AS HIGH AS THEY POSSIBLY CAN AND THEN THEY HAVE TO BACK DOWN ONCE IT DOES LIMITING TOXICITY. I HOPE SOMEDAY WE LOOK BACK AND SEE THAT AS THE DARK AGES. SO, I DON'T MEAN TO POINT A FINGER AT OUR RESEARCH SYSTEM, AND I AGREE, TOO THAT PATIENTS HAVE A ROLE IN IMPROVING THEIR HEALTH LITERACY AND UNDERSTANDING OF RESEARCH. WE HAVE A LOT OF WORK TO DO. BUT YOU CAN HELP, SOME OF THIS ENTAILS A GENEROSITY OF SPIRIT AND I HEARD THAT REFERRED TO TODAY IN THIS ROOM. I HEARD SOME OF YOU USING THIS MODEL--IN LAND EMPIRE AND CALIFORNIA SHE RARELY EVER SEES AN ONCOLOGIST, SHE SEES NURSE PRACTITIONER OR PHYSICIAN'S ASSISTANT. ANYWAY, I--I APPLAUD YOUR EFFORTS TO GET AS MUCH HIGH QUALITY INFORMATION INTO THIS DOCUMENT AS YOU POSSIBLY CAN BUT I ALSO THINK, YOU KNOW WE ARE--THESE ARE PATIENTS WHO JUST WANT REALLY ESSENTIAL EASY INFORMATION. I DON'T THINK WE NEED TO OVERDO THIS. ANYWAY, THANK YOU. >> THANK YOU. I THINK WE WILL DO QUESTIONS AT THE END. >> SO THANKS, DIANA, I THINK THAT SORT OF SET THE CONTEXT OF ANGST OF PATIENTS AND THE BOTH APPRECIATION AND FRUSTRATION WITH THE RESEARCH SYSTEM. I'M GOING TO TRY TO FOCUS A BIT MORE ON WHAT I THINK OUR TASK IS TODAY, IN THE INFORMED CONSENT AND I ALREADY TOLD YOU WHO I AM. I WILL SPEND JUST A SECOND TELLING YOU ABOUT THE CITY PROJECT BECAUSE I THINK THAT'S WHY IT WAS INVITED AND IT DOES FIT RIGHT IN WITH WHAT YOU WILL DO. I WILL SPEND MOST OF MY FEW MINUTES TALKING SPECIFICALLY ABOUT THAT DOCUMENT WE WENT OVER AND I TRIED TO CONTAIN THAT I MIGHT HAVE SAID OTHERWISE AND THEN 1 OF THE POINTS IN THAT DOCUMENT WAS THAT WE NEED TO DO RESEARCH ON IT, AND AND IN 2013 WE STARTED THIS CITY PROJECT ON CONSENT AND BASICALLY IT CAME FROM A GROUND SWELL BELIEF THAT INFORMED CONSENT WAS NOT VERY GOOD. --THIS WAS WE PROBABLY STARTED BEFORE THE ANNOUNCEMENT OF THE NEW COMMON RULE AND THEN WHILE WE DEPARTMENT KNOW WHETHER IT WAS ACTUALLY GOING TO BE CHANGED OR NOT AND WHEN--SO IT START OF WAS NOTES QUITE IN INC. BUT THE FIRST 1 FOCUSED ON THE PROCESS AND I THINK ACTUALLY SAID SOME MEANINGFUL THINGS AND CAME UP WITH A TOOL ABOUT HOW TO DO THE PROCESS AND I'LL BRIEFLY MENTION THAT LATER. FOCUSING AGAINOT PROCESS, WE TALKED ABOUT TRAINING STAFF TO DO CONSENT. WE SPENT A LOT OF TIME ON THE DOCUMENT AND MOST CRITICAL AND MOST RELEVANT TO WHAT WE'VE BEEN TALKING ABOUT HERE IS WE ENDED UP WITH THE IDEA OF A TIERED CONSENT AS WELL. AND WE ALSO EQUAL CONSENT WHICH WAS VERY NEW AT THE TIME. WE HAD THE VERY SAME PROBLEM THAT STEPHEN TALKED ABOUT AT THE BEGINNING. WHEN YOU TALK ABOUT TIERED CONSENT, WE HAD SOME PEOPLE SAW IT AND SAID EXECUTIVE SUMMARY 1 PAGE AND OTHER PEOPLE THAT SAID, UM, NO, EVERYTHING HAS TO BE IN IT. AND I CAN TELL YOU AND IT'S GOING TO SORT OF GIVE YOU A SENSE OF WHERE MUCH OF THE REST OF MY COMMENTS ARE, I'M PRETTY FAR ALONG THE LINE OF LESS IS BETTER, LESS IS MORE. AND I'LL TELL YOU WHY AND WHY MY REACTIONS OVER THE COURSE OF THIS MORNING ARE AND I HOPE THAT YOU'LL TAKE IT AS A POTENTIAL WARNING. I SOMETIMES AM ACCUSED OF A PATIENT ADVOCATE WHO DOESN'T REALLY KNOW ABOUT PATIENTS. AFTER ALL, I HAD MY OWN EXPERIENCE, I HAVE ADVANCED DEGREES, I FEEL COMFORTABLE TALKING TO A GROUP LIKE THIS AND WHAT DO I KNOW ABOUT PATIENTS? TO SOME EXTENT THAT'S VALID. WHO SHOULD BE A PATIENT ADVOCATE? BUT WHAT THING I TAKE QUITE A BIT OF TIME AND ENERGY DOING IS TALKING TO A LOT OF DIFFERENT PATIENTS AND PROBABLY MORE THAN I DO IN MY PERSONAL LIFE, I TALK TO PEOPLE WHO ARE REALLY DIFFERENT THAN ME, POLITICALLY, RELIGIOUSLY, ACADEMICALLY, EVERY DIFFERENT WAY AND IT'S--IT'S VERY IMPORTANT AND I CAN TELL YOU THAT WE ALL KNOW WHAT A CLINICAL TRIAL IS, WE KNOW ABOUT INFORMED CONSENT, BUT THERE ARE A LOT OF PEOPLE, PATIENTS WHO DON'T HAVE A CLUE ABOUT CLINICAL RESEARCH, YOU KNOW? ONE OF MYADVOCACY MESSAGE SYSTEM WE SHOULD HAVE A CURRICULUM IN JUNIOR HIGH ABOUT CLINICAL TRIALS AND THAT'S HOW WE GET PORE PEOPLE TO PARTICIPATE AND KNOW ABOUT IT BUT WE'RE IN A SOCIETY THAT DOESN'T DO THAT AND POO POOS SCIENCE AND SCIENCE IS GETTING A WORSE REPUTATION, SO WHEN WE WORRY ABOUT GIVING EVERYONE ALL THE INFORMATION THEY NEED TO MAKE A GOOD DECISION ABOUT CLINICAL TRIALS, RECOGNIZE THAT THEY ARE TOTALLY, MANY OF THEM, NOT ALL OF THEM ARE TOTALLY BLIND AND I THINK WE NEED TO PAY A SPECIAL ATTENTION TO THOSE BECAUSE THOSE THAT ARE INFORMED, WELL EDUCATED, AND NEED MORE INFORMATION, THEY WILL HAVE THE RESOURCES, SOMEHOW OR ANOTHER TO GET WHAT THEY NEED. THE PEOPLE THAT ARE CLUELESS ARE THE 1S THAT I THINK WE NEED TO PAY MORE ATTENTION TO AND I DON'T KNOW THAT WE'RE QUITE THERE YET. I GUESS IN THE DISCUSSION THIS MORNING, I THINK WE MAYBE HAVEN'T BEEN THERE AND THAT'S WHY I WOULD ADVOCATE FOR A SHORT CONCISE DOCUMENT THAT DOESN'T HAVE SO MUCH INFORMATION. IF WE ARE GOING TO HAVE AN INFORMED CONSENT ANYWAY, THE INFORMATION COULD BE THERE OR AN APPENDIXES, BUT GET SOMETHING THAT HELPS PEOPLE FIGURE OUT WHAT THEY NEED TO KNOW. THE ANALOGY I LIKE TO MAKE IS 1 OF WHEN I WENT TO SIGN MY FIRST LEGAL PAPERS FOR MY MORTGAGE, I DIDN'T EVEN UPON WANT TO KNOW, MY LAWYER WAS SAYING THIS IS WHAT YOU NEED TO KNOW, I THIS IS WHAT YOU NEED TO KNOW. I THINK FOR MANY PATIENTS THAT'S WHAT THEY NEED TO KNOW IS I THINK THAT'S THE KEY INFORMATION AND IF THEY WANT, IF IT'S RELEVANT TO THEM, AND THEY HAVE THE CAPACITY TO KNOW THEN THEY CAN GO AND FIND IT IN THE CONSENT. MY BIAS, BUT HOPEFULLY, YOU WILL THINK ABOUT IT A LITTLE BIT. SO I GUESS THAT'S WHERE I START, NOT EVERYONE ON THE CITY TEAM QUITE AGREED WITH ME WHICH IS WHY WE LEFT A BASE ABOUT HOW MUCH TIERED SHOULD BE. SO THIS IS WHAT COMES FROM YOUR--THESE ARE YOUR QUOTES AND THEN WHAT I'VE BEEN TRYING TO SAY. I THINK THE KEY INFORMATION SHOULD BE VERY GENERAL AND THE INFORMATION IN SUFFICIENT DETAIL COULD BE IN THE OTHER FORM. I THINK BRIAN DID A REALLY GREAT JOB OF AND PROVIDED REALLY GREAT INFORMATION AS DID HIS COLLEAGUES, BUT LET ME GIVE YOU A SENSE OF WHAT I MEAN BY THIS. REMEMBER, I THINK IT WAS STEPHEN THAT HAD SOME TEMPLATE INFORMATION THAT SAID--IT WAS A PROSTATE TRIAL--HE SAID SOMETHING LIKE, I WILL PARAPHRASE THIS BECAUSE IT'S MORE GENERIC, SORT OF WHAT I THOUGHT OF, IT'S SORT OF LIKE CANCER TREATMENTS ARE GENERALLY LEAD TO SIGNIFICANT SIDE EFFECTS WHETHER YOU'RE IN STANDARD OF CARE OR IN A CLINICAL TRIAL. IF YOU CHOOSE TO BE IN A CLINICAL TRIAL, THE DRUG--DEPENDING ON THE PARTICULAR TRIAL, THE DRUG PROBABLY HAS LESS BEEN USED IN FEWER PEOPLE AND WE KNOW LESS ABOUT THE SIDE EFFECTS, AND COULD BE EVEN MORE CONSEQUENTIAL. FOR DETAILS ABOUT THOSE SIDE EFFECTS, GO TO THIS SECTION IN THE MAIN DOCUMENT. THAT'S WHAT I WOULD LIKE TO SEE IN KEY INFORMATION, SO WE'RE NOT TELLING THEM WHAT THEIR RISKS ARE, WE'RE CALIFORNIAING THEM THAT THERE ARE SIGNIFICANT 1S THAT'S CANCER AFTERALL AND IT MAY BE MORE FOR IN A CLINICAL TRIAL. THAT'S WHAT I VIEW AS KEY INFORMATION. ON THE OTHER HAND, LISA GAVE US THIS TABLE OF--REPORT SIDE EFFECTS AND I THINK THAT WAS GREAT AND IT CAPTURED A LOT OF THINGS THAT I HAVE IN A SLIDE LATER ABOUT THINGS THAT ARE IMPORTANT TO PATIENTS AND RISKS. BUT THAT'S NOT KEY INFORMATION, ALTHOUGH LITTLE DETAILS, THAT TO ME IS WHAT GOES IN THE DETAILS, AND THEN SOMEBODY READING THE KEY INFORMATION KNOWS THAT THEY SHOULD BE CONSIDERING IT, THEY SHOULD DECIDE WHICH EFFECTS THEY ARE MOST CONCERNED ABOUT. LIEK WISE WE DEBATED WHAT SHOULD BE IN THE FINANCIAL KEY INFORMATION. MY PERSONAL BELIEF IS THAT FINANCIAL BURDEN OF BEING IN CLINICAL TRIAL SYSTEM VERY MUCH INCREASING, AT LEAST FOR CANCER PATIENTS, AND THERE SHOULD BE A WARNING IN KEY INFORMATION. I DON'T THINK IT'S ABSOLUTELY REQUIRED. IT'S CERTAINLY NOT REQUIRED FOR ALL TRIALS ABOUT YOU FOR A CANCER TRIAL, IN THAT 1 PAGE SUMMARY, I DON'T THINK IT'S BAD TO SAY, THERE MAY BE FINANCIAL CONSEQUENCES TO BEING IN THIS TRIAL. YOU SHOULD LOOK AT THIS OTHER PART OF THE INFORMED CONSENT THAT SAYS WHAT'S COVERED OR NOT AND TALK TO YOUR INSURANCE COMPANY. SO JUST THIS RED FLAG WITH A POINTER TO DOWN THE ROAD. SO THOSE ARE A FEW OF THE EXAMPLES. I ALSO THINK IT'S KEY INFORMATION BUT 1 OF THE OTHER THINGS THAT CAME UP THAT WAS NOT IN THE ORIGINAL DOCUMENT HAD TO DO WITH WHAT YOUR FUTURE CARE IS. I DON'T THINK MOST INFORMED CONSENTS ADEQUATELY TELL PATIENTS THAT THIS COULD EFFECT WHAT STANDARD OF CARE TREATMENTS THEY COULD HAVE IN CANCER, IT COULD CERTAINLY EFFECT WHAT FUTURE TRIALS THEY COULD BE IN. AS WELL AS HOSPICE WHICH WE MENTIONED. I DON'T THINK WE HAVE TO GET INTO THE DETAILS AND KEY INFORMATION BUT IN SOME CASES, WE MIGHT WANT TO SAY IT. AND ANOTHER SIDE, MY PERSPECTIVE IS PRIMARILY CANCER. YOU ARE DOING THAT AS WELL, BUT I THINK IT'S IMPORTANT NOT TO JUST LOOK AT CANCER, BUT I DO HAVE TO MAKERS AND A GENERAL STATEMENT THAT NO 1 HAS DISAGREED WITH ME OVER THE MANY YEARS I'VE MADE IT AND PEOPLE DISAGREE WITH ME, I DISAGREE WITH MYSELF MOST OF THE TIME. BUT A CANCER PATIENT WHOSE DECIDING ABOUT A CLINICAL TRIAL WHO JUST GOT A CANCER DIAGNOSIS BY AND LARGE NO MATTER HOW SMART AND DUM THEY ARE, THEY ARE FUNCTIONING AT ABOUT HALF THEIR CAPABILITY. SO LESS IS MORE. I REALLY DO BELIEVE AND FOR OTHER LISTS, SERIES TRIALS SO THAT INFORMED CONSENT, THAT FIRST SUMMARY CAN BE GONE OVER VERY FAST AND IT'S FOCUS ON THE AN ISSUE. FOR THE CANCER PAIBT THAT MIGHT BE ALL THEY COULD ABSORB, THAT FIRST TIME THAT THEY'RE LOOKING AT IT AND IT MAY ONLY BE THEIR FRIENDS AND RELATIVES THAT ARE ACTUALLY GOING TO BE ABLE TO HELP THEM WITH THE REST OF IT. SO THAT'S SORT OF MY PIECE. SO WHAT I TRIED TO DO IS GO OVER THE 5 ELEMENTS, AND GIVE MY OWN PERSPECTIVE. JUST--I GOT BACK FROM THE GALAPP A GOS SATURDAY NIGHT. SUNDAY I DID LAUNDRY AND DECOMPRESSED AND MONDAY I LOOKED AT YOUR MATERIAL. SO THAT'S MY EXCUSE BUT IT WAS DEFINITELY WORTH IT. ANYWAY WHAT I THOUGHT SHOULD BE IN THE UPFRONT SUMMARY AND THE BODY AND I THINK A LOT OF THE DISCUSSION HERE, WE HAVEN'T ACTUALLY ALWAYS DISTINGUISHED THAT. I THINK A LOT OF THE DISCUSSION HERE WAS GREAT, BUT SHOULD REALLY BE FOCUSING ON THE SUMMARY, AND WE SHOULD FIND A WAY TO REALLY IMPROVE THE SUMMARY AND I THINK BRIAN AND HIS FOLKS ARE ESPECIALLY HELPFUL IN THAT. BUT THE FACT THAT CONSENT IS BEING SOUGHT FOR RESEARCH AND PARTICIPATION IS VOLUNTARY. DEFINITELY THAT HAS TO BE IN THE SUMMARY AND THAT'S SORT OF THE INVITATION AND THANK YOU. WE--LATER ON ARE GOING TO GET TO THE QUESTION OF WHETHER OR NOT TO REPEAT. I THINK YOU CAN SORT OF REMIND--IN THE CONTENT, YOU CAN REMIND THEM THAT THEY--THIS IS VOLUNTARY AND THAT MIGHT BE WHERE YOU ELABORATE ABOUT YOU CAN WITHDRAW AT ANY POINT AND THIS IS THE PROCEDURE FOR WITHDRAWAL. SO THAT WOULD BE ANOTHER KIND OF EXAMPLE OF IT. THE PURPOSES AND DURATION AND PROCEDURES AND ALL THAT, I THINK IT SHOULD BE PRETTY MINIMAL IN THE UPFRONT PART. BUT ALL THE SPVENGS IN THE SCHEDULE AND EVEN THAT DIAGRAM THAT LISA PRESENTED, I THINK THAT SCHEMA IS BEAUTIFUL. I DON'T KNOW THAT THAT'S WHAT BELONGS IN A SUMMARY. I THINK USING SOMETHING LIKE THAT WOULD BE 1 OF THE GREAT THINGS FOR IMPROVING AND MAYBE MAKING MORE CONCISE THE INFORMED CONSENT. REASONABLE AND FORESEEABLE RISKS, WE ALREADY TALKED ABOUT THAT AND I HAVE A FEW MORE COMMENTS THAT SORT OF I THINK NOT NEARLY AS ELOQUENTLY AS LISA DID, TALK ABOUT THAT. THE BENEFITS TO PREVENT PERSPECTIVE SUBJECT AND WHAT OTHER REASONABLE THING. I THINK AGAIN GENERAL AND THEN SPECIFIC IN THE CONTEXT. ONE OF THE THINGS I DIDN'T COMMENT ON ABOUT BRIAN AND IT MAY BE SOMETHING YOU WANT TO CONSIDER IS, TALKING ABOUT ALTERNATIVES, IS GREAT BUT I'M NOT SO SURE THAT THAT CAN AND SHOULD BE DONE IN AN INFORMED CONSENT, PARTICULARLY FOR A CANCER CLINICAL TRIAL. NOW MAYBE IF YOU ARE DOING IT VERY GENERICALLY LIKE BEING IN OTHER CLINICAL TRIAL, OR HAVING STANDARD OF CARE OR NOTHING, THAT'S OKAY, BUT YOU KNOW, AS A SERIOUS CANCER PATIENT WHO'S THINK BEING A CLINICAL TRIAL IS COMPARING CLINICAL TRIALS AND NEEDS TO GET INTO THE NITTY-GRITTY. SO I THINK THAT TABLE COULD BE VERY USEFUL TO A PATIENT DEFINITELY IN MY OPINION DOES NOT BELONG IN THE KEY INFORMATION PREAMBLE AND WHETHER OR NOT IT CAN BE APPLIED IN THE REST IS OPEN TO CONSIDERATION. THE ALTERNATIVE PROCEDURES PROCEDURES--AGAIN THAT'S WHAT I WAS JUST TALKING ABOUT. THE PARTICULAR QUESTIONS YOU JUST HAD, HERE ARE MY REACTIONS, I THINK THE KEY ELEMENTS ARE REALLY QUITE REASONABLE. I THINK THERE'S A LOT OF VERSE THINGS WE CAN MODIFY, I THINK THERE ARE ALTURNOVERRIVES THAT COME UP IN THE DISCUSSION, I REALLY LOVE THAT IN THE DOCUMENT YOU TALKED ABOUT FLEXIBILITY BUT I ALSO KNOW THAT PEOPLE GET REALLY INTO COMPLIANCE AND CHECK LISTS SO I THINK THAT NEEDS TO BE THOUGHT ABOUT AS YOU WRITE FOLLOW UP. I WILL HAVE THE CORRECT 1S. TOOLS, REPETITION. WE TALKED ABOUT ALL THAT. THESE WERE SOME ADDITIONAL THINGS I THOUGHT YOU MIGHT CONSIDER. NOTHING IMPORTANT THERE. QUITE FRANKLY, I ALREADY HINTED AT THAT. I DON'T THINK THE TOOLS I SAW IN THE DOCUMENT ARE READY FOR PRIME TIME AND I WOULD URGE YOU NOT TO PUBLISH ANYTHING BEFORE IT IS READY FOR PRIME TIME. I DID SITE A FEW OTHER TOOLS THAT I THOUGHT MIGHT BE OF INTEREST PEOPLE ALREADY TALKED ABOUT THE TOOLS AND THAT IS QUITE HELPFUL AND YOU WILL HAVE THAT AS A REFERENCE. DESCRIBING RISK, LISA COVERED THIS BETTER THAN I WILL SO I WON'T EVEN WASTE YOUR TIME ON IT. COMMENTS ON RESEARCH, YOU KNOW, I KNOW THAT THE GOAL HERE IS DO PEOPLE UNDERSTAND ENOUGH TO MAKE A DECISION BUT A LOT OF RESEARCH HAS AND WILL BE DONE ON INFORMED CONSENT HAS A LITTLE BIT OF--IT'S UNCLEAR WHETHER WE'RE LOOKING FOR UNDERSTANDING THE, THE PATIENT SATISFACTION WITH BEING ABLE TO MAKE A DECISION AND THE OTHER THING IS THE SATISFACTION RIGHT AFTER YOU WRITE THE CONSENT COULD BE QUITE DIFFERENT THAN WHEN YOU'RE IN THE TRIAL OR AFTERWARDS. AND I THINK THAT IF YOU ARE THINKING ABOUT RESEARCH, YOU MAYMENT TO ASK THEM 2 DIFFERENT TIMES BECAUSE YOU CAN FEEL LIKE YOU UNDERSTAND IT AND YOU'RE VERY SATISFIED WITH IT IF YOU ASK RESEARCH QUESTIONS AFTER THEY READ THE CONSENT AND THEN ONCE YOU GET IN THE TRIAL, YOU SAY WAIT A SECOND, THIS IS ISN'T THE TRIAL I THOUGHT I SIGNED UP FOR. SO I WOULD BE REALLY CAUTIOUS ABOUT THAT. IT'S ALSO IMPORTANT WHEN YOU DO THIS RESEARCH AND I USED TO DO COMPREHENSION RESEARCH, YOU KNOW WHAT IS SPECIFIC TO THE PARTICULAR CONSEBT SENT VERSUS WHAT ARE THE GENERAL PRINCIPLES ARE VERY, VERY HARD TO DISCRIMINATE. AND I THINK WHAT SACHRP WANTS TO DO IS FOCUS ON GENERAL PRINCIPLES AND BEST PRACTICES, I WOULD URGE YOU TO CONSIDER GETTING SOME SORT OF DESIGN EXPERTS INVOLVED. WHAT SIZE FONT? WHAT KIND OF BOLDING? HOW MUCH WHITE SPACE? I WOULD LOVE TO HAVE A LONGER DOCUMENT WITH MORE WHITE SPACE THAN A DOCUMENT THAT'S SIZE 8 FONT. ADDITIONALLY, I KNOW YOU FOCUSED A FAIR AMOUNT ON DIFFERENT TYPES OF TRIALS BUT THE DIFFERENCES I TRY--MY BEGINNING COMMENTS TO FOCUS ON THAT. I KNOW I'M A LITTLE BUSINESS PROGRAMS--DYSLEXIC, TO ME THE SENSOR WITHOUT THE LITTLE DOODADS IS HARDER TO READ AND DO BETTER WITHOUT IT. BUT THE AVERAGE PERSON READS BETTER WHEN THEY HAVE THOSE LITTLE DOODADS. SO MY NEXT SLIDE HAS TO ACTUALLY DO WITH ELECTRONIC INFORMED CONSENT. MAYBE WE COULD ADAPT IT TO WHAT THE PATIENT NEEDS. --BECAUSE NO POPULATION IS REALLY THE RIGHT KIND OF POPULATION TO DO THIS KIND OF RESEARCH AND I THINK DAVID--I THINK BRIAN IS AN M. D. BUT HE GETS BEHAVIORIAL RESEARCH BUT NOT ALL CLINICIANS DO BUT ALL OF THEM THINK THEY CAN DO IT SO I HAD TO PUT IN THE LAST LINE. AND FINALLY, CONTINUOUS IMPROVEMENT. I THINK WE REALLY WANT TO ENCOURAGE PEOPLE TO DO CONTINUOUS IMPROVEMENT BOTH IN TERMS OF A PARTICULAR CONSENT AND THE PRINCIPLES. AND I HOPE I'M STILL ALIVE WHICH MEANS IT PROBABLY HAS TO BE 20 YEARS AT THE NEXT REVISION OF COMMON LAW. MAYBE YOU WILL LAUGH AT THAT. MAYBE NOT. THAT'S MY SENSE OF HUMOR, I DON'T SEE JERRY'S FACE BUT HE WILL BE RETIRED BY THEN. AT ANY RATE, SOMEONE MENTIONED THAT ELECTRONIC CONSENT IS SUCH A PERFECT PARADIGM FOR THIS TEARED--FOR WHAT YOU'RE TRYING TO DO SO ENCOURAGING THAT AND IT'S ALSO A GREAT RESEARCH TOOL AND THIS INFORMED--IT MAY BE THAT YOU HAVE TO GET IRB PERMISSION TO DO RESEARCH ON THE INFORMED--YOU KNOW I'M NOT SURE EXACTLY HOW ITERATIVE THIS IS, AND WHETHER IT WOULD WORK, BUT CAN YOU COLLECT STATISTICS ON WHAT TAKES TIME, WHERE PEOPLE ARE HOVERING, WHERE PEOPLE ARE CLICKING AND YOU CAN LEARN FROM THAT, BOTH ACROSS DIFFERENT TRIALS BUT ALSO WITHIN A TRIAL, I--YOU HAVE TO DO AN AMENDMENT, I GUESS TO CHANGE HOW YOU'RE INFORMED CONSENT IS WHICH WOULD BE A DISASTER BUT ON THE OTHER HAND IF YOU COULD ACTUALLY--YOU KNOW IF EVERYONE IS LOOKING UP A DEFINITION, YOU COULD 'EM BED THAT DEFINITION IN THE CONSENT OR YOU KNOW SOME OTHER THINGS. SO, THOSE ARE MY COMMENTS. I APPRECIATE THE INVITATION. I ADMIRE THE WORK YOU DO AND I THINK IT'S CHALLENGING AND I ENCOURAGE YOU TO THINK ABOUT THE PATIENT THAT NEVER AS INFORMED AS YOU ARE AND THEY'LL NEVER KNOW EVERYTHING, WHEN YOU MAKE OF THE DECISION IS MORE IMPORTANT THAN THE DECISION BUT THEY WANT DIFFERENT AMOUNTS OF INFORMATION TO HELP THEM GET IT. [ APPLAUSE ] >> THANK YOU. RICHARD? >> GOOD AFTERNOON EVERYONE. FIRST OF ALL I ENJOYED THE PRESENTATIONINGS, I READ THE MATERIAL A LOT BUT I APPRECIATE THE INSIGHT FOR THE PATIENT PERSPECTIVE AND THAT'S WHAT I WANT TO DID THIS AFTERNOON.& I WANT TO GIVE YOU SOME PERSPECTIVE, I DID READ THE DOCUMENTS, DO A LOT OF WORK WITH INFORMED CONSENT BUT I THINK THAT IT HELPS TO HAVE A LITTLE BIT OF MORE INSIGHTS AND 1 THINK THIS I WANT TO DO IS GIVE YOU INSIGHT AS TO WHAT WE DO AND HOW WE DO IT. OUR ORGANIZATION WE'LL ARE BRIEF, WE'RE A NEW ORGANIZATION, I KNOW SOME PEOPLE ARE FAMILIAR WITH THE OTHER RENAL ORGANIZATIONS, NKF, AKF, ALL THOSE ACRONYMS BUT WE ARE THE ORGANIZATION THAT BACK IN THE LATE 60S, EARLY 70S WAS DEVELOPMENT OF THE END STAGE RENAL DISEASE PROGRAM AS ADVOCATES. OUR ROLE: EDUCATE, ADVOCATE AND WE SPEND TIME FOR PATIENT ENGAGEMENT AND I WILL TALK A BIT MORE ABOUT THAT A BIT LATER BECAUSE WELL, WE WILL GET INTO THAT DETAIL BUT. BUT WE WILL TALK ABOUT INFORMED CONSENT BECAUSE WE DO A LOT OF EDUCATION ON THE PATIENTS TO MAKE THEM A BIT MORE RECEPTIVE. AGAIN, WE ALSO WANT TO REPRESENT THAT UNIQUE RELATIONSHIP BETWEEN THE PATIENTS AND THE DOCTORS AND CERTAINLY THE UNDERSTANDING, EXPLAINING AND HAVING CLARIFICATION ON DOCUMENT LIKE THE INFORMED CONSENT IS CRITICAL . NOW JUST A COUPLE OF CHALLENGES. I THOUGHT ABOUT INFORMED CONCEPT AND 1 THE AREAS--WELL, LET ME DO LET'S GO HERE FIRST AND I WILL COME BACK TO THAT. IN TERMS OF CONTEXT, RELEVANT ACTIVITIES THAT THE AMERICAN ASSOCIATION OF THE PATIENTS, I'M VICE PRESIDENT OF CHAIR AND PUBLIC POLICY AND MY COLLEAGUE WHO IS NOT HERE, HE'S AT A BOARD MEETING FOR UNOS, I BELIEVE OUT IN CHICAGO. THESE ARE ACTIVITIES WE HAVE BEEN INVOLVED WITH IN OUR ORGANIZATION AND THE 2 OF US HAVE BEEN REPRESENTED AND OTHERS WHO HAVE BEEN VERY ACTIVE. AND WE'VE BEEN INVOLVED IN THE KIDNEY INITIATIVE WITH THE FDA, PRIVATE SECTOR, FIRMS, PHARMA, UNIVERSITIES, RESEARCHERS SIMILARLY AND YOU DID A GREAT JOB EXPLAINING CTTI, WE HAVE BEEN INVOLVED IN THAT. I HAVE HEAVY INVOLVEMENT IN THE NIDDK KID ME PRECISION--KIDNEY PRECISION MEDICINE PROJECT. RESEARCH ON RENAL ISSUE SYSTEM PROBABLY ABOUT 20 YEARS BEHIND SCANSER AND THIS IS AN EFFORT, WHAT I CALL A LARGE SCALE EFFORT TO REALLY DIVE INTO ALL THINGS KIDNEY. AND WE HAVE SPENT CONSIDERABLE TIME IN THE COMMUNITY ENGAGEMENT WORK GROUP OF WHICH I'M A CO-CHAIR, WORKING WITH OTHER PATIENTS TO DO EXACTLY WHAT THE LADIES ARE TALKING ABOUT WHICH IS TO HELP THEM UNDERSTAND THE PROCESS, WHAT'S GOING ON IN THE PROJECT AND PRIMARILY, FEEL COMFORTABLE ABOUT INFORMED CONSENT AND WE SPENT A LOT OF TIME ACTUALLY DEVELOPING THAT PRODUCT. IT IS THE ROLE OF THE COMMUNITY ENGAGEMENT WORK GROUP UNDERNEATH THE KPMP TO DEVELOP THAT, WITH INPUT FROM THE VARIOUS OTHER WORK GROUPS, ALSO. I ALSO SERVE ON THE NIDDK ADVISORY COUNCIL. MY COLLEAGUE, AGAIN WHO IS NOT HERE IS CHAIR OF THE PATIENT ENGAGEMENT ADVISORY COMMITTEE FOR FDA AND WITH RESPECT TO EVEN FURTHER EDUCATION, WE HOST PERHAPS THE LARGEST ANNUAL PATIENT MEETING FOR RENAL PATIENTS IN THE COUNTRY AND WE WILL HAVE A TRACK THIS YEAR ON CLINICAL TRIALS. WE HAD IT SCHEDULED LAST YIER AT THE EXACT SAME TIME THE HURRICANE HIT FLOR FLOOR, SO WE HAD TO--THE HURRICANE HIT FLORIDA SO WE HAD TO RESCHEDULE IT AND IT WILL BE THIS UPCOMING JUNE. NOW WE WILL GO BACK TO THIS 1 AND TALK ABOUT SOME OF THEM, I WILL CALL THEM CHALLENGES. I READ THE DOCUMENT, THE DOCUMENT THAT YOU HAD WAS VERY SIMILAR TO THE 10 PAGE DOCUMENT THAT WE CAME UP WITH AND 1 OF THE THINGS WE TALKED ABOUT, AS PATIENTS WAS, WE NEED A SUMMARY PAGE. SO CERTAINLY WE'RE IN AGREEMENT AND SYNCH WITH THAT. REIMBURSEMENT SYSTEM, I USE MY OWN DEFINITION HERE, NOT GOING OUT AND IMETTING REIMBURSED FOR HEALTHCARE OR ANYTHING BUT 1 OF THE THINGS WE NEED TO DO IS WE DON'T PAY PATIENTS TO PARTICIPATE IN CLINICAL TRIALS, BUT WE CERTAINLY NEED TO REMOVE THE DISINCENTIVES SO AT LEAST THE IMPACT CAN BE 0. AND YOU WOULD BE SURPRISED. I WENT TO A MEETING THE OTHER DAY, I HAD TO DRIVE AND I SAID I WILL GO OVER THERE AND PARK BECAUSE I DIDN'T HAVE TIME TO TAKE THE METRO. THE PARKING WAS $45. GOOD OLD WASHINGTON D. C. AND I ENDED UP NOT PARKING THERE I SAID LET ME GO DOWN AND PARK DOWN THE STREET AT THE OTHER 1 THAT WAS 42. SO CONFIDENTIALITY. OF COURSE WE ALL SWEAR TO CONFIDENTIALITY. WE CODE THINGS WE MAKE IT SO THAT THE INFORMATION IS NOT AVAILABLE, AND LET ME JUST SAY THAT A YEAR AGO, 2 YEARS AGO, I GOT A LETTER THAT MY INFORMATION WHEN I HAD SECURITY CLEARANCE 20 YEARS AGO WAS IN CHINA. SO I'M JUST SAYING THAT THAT'S SOMETHING TO WE NEED TO MAKE CERTAIN THAT THE PATIENTS ARE COMFORTABLE WITH THAT AND AS MUCH AS WE WANT TO SAY THAT EVERYTHING IS LOCKED DOWN, WELL, SOMETIMES IT ISN'T BUT SERIOUSLY FOR THE PATIENTS, THE REAL CONCERN IS, AND 1 OF THE THINGS THAT FOR EXAMPLE, WE ADVOCATE ON IS THE LIVING DONOR PROTECTION ACT. IF YOU GIVE SOMEONE A TRANSPLANT WELL THE INSURANCE COMPANY WON'T GIVE YOU LONG-TERM INSURANCE, WON'T GIVE YOU DISABILITY INSURANCE, YOU HAVE HEALTHCARE BUT NOT THE OTHER AND STATISTICALLY IN ORDER FOR YOU TO BE ABLE TO GIVE SOMEONE A KIDNEY, YOU HAVE GO THROUGH A BATTERY OF TESTS, YOU WILL BE MUCH HEALTHIER THAN THE GENERAL POPULATION SO DISCIPLINARY SOMETHING SILLY AND SAID, WELL, HAVE YOU DONE ANY ANALYSIS TO DETERMINE THAT THE DONORS ARE LESS HEALTHIER THAN THE GENERAL POPULATION BECAUSE TYPICALLY THEY'RE MUCH HEALTHIER EVEN AFTER THEY DONATE THE ORGAN. THAT DOESN'T MATTER. THAT'S SOMETHING THE PATIENT HAVE TO DEAL WITH SO THOSE WHO ARE IN A POSITION TO GET AN ORGAN, I MAKE CERTAIN, LET YOUR PERSON KNOW IF IT'S COMING FROM A LIVING DONOR TO TAKE CARE OF THEIR LIFE INSURANCE AND ALL THAT BEFORE THEY DO IT. JUST LITTLE THINGS LIKE THAT THAT PATIENTS SIMPLY AREN'T GOING TO KNOW THAT. INTIMIDATION, PATIENTS CAN OFTEN TIME BE INTIMIDATED BY THE WORDS, BY THE LANGUAGE, BY THE DEMEANOR, BY RESEARCHERS AND DOCTORS STANDING UP AS THE PATIENT IS SITTING DOWN. LITTLE THINGS LIKE THAT THAT HAVE TO DO SOMETHING MUCH MORE THAN WITH THE LANGUAGE IN THE DOCUMENT BECAUSE ULTIMATELY IT BOILS DOWN TO: DO THEY TRUST YOU? LOW LITERACY RATES. WHEN IT COMES TO HEALTHCARE MOST PEOPLE HAVE A LOW LITERACY RATE. I OFTEN PRESENT A LOT OF TIMES WITH HEALTHCARE PROFESSIONALS, AND AS WE--1 DOCTOR WAS ENGAGED IN A CONVERSATION. HE WAS EXPLAINING TO PATIENTS ABOUT, YOU KNOW HYPER URESEMIA AND NO 1 KNOW THAT AND HOW MANY HAD GOWT, AND HALF THE ROOM RAISED THEIR HANDS AND THEY UNDERSTOOD IT BETTER WHEN I SAID IT SO LET'S BREAK THE LANGUAGE DOWN AND BREAK IT UNDERSTANDABLE. DISPARITIES. IN THIS PROJECT THAT WE'RE DOING THE KPMP 1 OF THE THINGS THAT THEY DID RESEARCH ON, SOME OF THE PATIENTS THAT WERE PARTICIPATING AND THEY DETERMINE THAT THEY WEREN'T HAVING A SUFFICIENT LEVEL OF PARTICIPATION FOR MINORITIES STATISTICALLY SPEAKING AND FROM OLDER PATIENTS AND I SAID TO DOC, I SAID I WONDER WHY? HE SAID WE DON'T REALLY KNOW. WE NEED TO DO FURTHER RESEARCH ON THAT. I SAID SERIOUSLY? I SAID DOC, I CAN GIVE YOU REAL STRONG IDEAS AS TO HOW YOU CAN IMPROVE YOUR RATES WITH BOTH OF THOSE. BECAUSE UNFORTUNATELY, AM I CONSIDERED ELDERLY? WHAT'S THE NUMBER? IS THERE A CERTAIN NUMBER? [LAUGHTER] WELL, I THINK--AARP SAYS 50, WELL I'M WELL PASSED THAT. MUCH PAST THAT BUT THAT'S A SERIOUS ISSUE BECAUSE IF WE ARE GOING TO DO CLINICAL TRIALS AND MY INFORMATION IS AND THE CENTER OF THE POPULATION, 32% OF THE POPULATION IS ON DIALYSIS. AND WE ARE TRYING TO SAVE DOLLARS ASK REPRESENT 1% OF THE MEDICARE POPULATION, PLUS A PERCENT OF THE COST. UNACCEPTABLE. THAT'S NOT A NUMBER THAT CAN CONTINUE. SO I'M SAYING ALL THESE SMART PEOPLE DON'T UNDERSTAND THAT IF YOU GO WITH THE SMALL, 13% AND DO THINGS TO ENHANCE AND IMPROVE THAT, YOU WILL HAVE AN EFFECT ON THAT, 7% COST FACTOR. STILL, I'M TRYING TO WONDER WHY WE HAVEN'T DONE THAT. AND ANOTHER PROJECT THAT WE'RE STARTING OVER AT NIDDK IS THE APOLLO PROJECT. WE ARE TAKING A LOOK AT THAT NONMEDICAL PERSONNEL, AT THE RISK OF THOSE OF AFRICAN AMERICAN HERITAGE LOSE THEIR KIDNEYS OF 4 TO 1 OVER CAUCASIAN POPULATION. THAT'S SIGNIFICANT. SO ALL THOSE PARTICULAR PROJECTS REQUIRE INFORMED CONSENT AS AN ONGOING PROCESS AND AS A GROUP THAT COMMUNITY ENGAGEMENT WORKING GROUP, WE HAVE SPENT CONSIDERABLY TIME LOOKING AT THAT DOCUMENT AND FLESHING IT OUT AND 1 OF THE THINGS I NOTED WAS AMBIGUITY OF DEFINITIONS. WITHIN THE DOCUMENT, THEY TALK ABOUT, WELL, YOU KNOW YOUR INSURANCE NEEDS TO PAY FOR THIS AND I'M THE 1 THAT ASKS UGLY QUESTIONS, SO WHAT HAPPENS IF THERE'S AN INJURY THAT RESULT FROM THE RESEARCH OR AN ADDITIONAL ILLNESS WHO PAYS FOR THAT? AND THE ROOM GOT SILENT. I SAID WELL THE I GUESS I ANSWER IS THAT YOU YOU DON'T PAY IF ARE IT, SO THE BURDEN IS ON THE PATIENT IS THAT CLEARLY ARTICULATED TO THEM? THESE ARE WHAT WE HAVE TO TAKE INTO CONSIDERATION, PARLIAMENT OF ALL OF THIS, YOU KNOW I HAVE A TENDENCY TO RELATE THINGS TO EACH OTHER, AND ALL OF THIS GETS BACK TO--LET ME SEE HERE--DON'T LET ME GET YOU DIZZY AS I GO AROUND. I WANT TO GO TO MY PRETTY PICTURE. SIEM SORRY, I USUALLY DO STAND UP AND DO CLASS FOR 2 AND HALF 3 HOURS, IT WAS MY BIRTHDAY SO WE DIDN'T HAVE CLASS LAST NIGHT. SO 1 THING THAT I POINT OUT TO PEOPLE, WHEN YOU WANT TO DEAL WITH PATIENTS AND PEOPLE TALK ABOUT PATIENT ENGAGEMENT, WELL THAT'S JUST A WORD TO MOST PEOPLE. AND I'M GIVEN CREDIT TO THE PERSON WHO DEVELOPED THAT. A LOT OF WHAT WE'RE TALKING ABOUT WE NEED TO HAVE PEOPLE ARE AT THIS PARTICULAR SECTION RIGHT THERE WHICH IS THE HIGHEST LEVEL OF PATIENT ENGAGEMENT. SO AS WE ENGAGE PATIENTS, ALL DOCTORS ARE NOT CREATED EQUAL, ALL PATIENTS ARE NOT CREATED EQUAL. YOU NEED TO BRING PATIENTS ON BOARD THAT CAN GIVE YOU THE DESIRE RESULTS IF YOU WANT TO HAVE THEM PARTICIPATE, ASK QUESTIONS AND HELP ENHANCE THAT INFORMED CONSENT DOCUMENT OR ANYTHING ELSE IT IS THAT YOU'RE CO-WORKERSING ON. --WORKING ON. WE SPEND A LOT OF TIMES WITH PRIVATE SECTOR FIRMS TALKING ABOUT CLINICAL TRIALS, ALL THE ORGANIZATIONS THAT I MENTION EARLY, FOR EXAMPLE, USED TO RUN IN REEJIENS, AND THEY SAY WHY DON'T YOU COME TALK TO US, WE CAN HELP YOU GET PATIENTS, I'M LISTENING TO PEOPLE'S BEHAVIOR, YOU SEE, YOU HAVE PATIENTS IN YOUR CLINICAL TRIALS AND AND THEY CONTINUE TO EDUCATE THEM, SO THAT THEY CAN UNDERSTAND YOU KNOW, I'M NOT THE BRIGHTEST GUY IN THE WORLD, WHEN I WAS IN SCHOOL, I HAD TO READ SOMETHING 3 OR 4 TIMES. SO YOU EXPLAIN SOMETHING TO A PATIENT AND THEY YES, I BED AND THEY DON'T HAVE A CLUE. SO TO THE EXTENT THEY HAVE SOME FUNDAMENTAL TRAINING WHEN THEY HAVE A CONVERSATION ABOUT INFORMED CONSENT, THEY'LL HAVE A POINT OF REFERENCE TO WHICH THEY CAN RELATE. SO I THINK THIS CAN BE VERY HELPFUL TO YOU, UNDERSTANDING THAT THE WHOLE CONCEPT OF PATIENT ENGAGEMENT IS MUCH MORE THAN LISTENING TO QUITE FRANKLY A PATIENT'S STORY AND AGAIN, I THINK 2 LADIES YOU HAD UP HERE ARE GREAT, GREAT EXAMPLE OF THOSE THAT CAN REALLY PARTICIPATE AT THE PARTNERSHIP AND SHARED LEADERSHIP AND THE POLICY MAKING LEVEL, WHICH IS WHERE WE'RE GOING TO LOOK AT, DEALING WITH INFORMED CONSENT. ME, AND THIS LITTLE THING HERE. --AND THE PATIENT CONFERENCE COMING UP JUNE 8th AND 10th DOWN IN ST. PETERS BERG, FLORIDA, WE WERE ABLE TO RESCREDDULE IT. WE PROVIDE HEALTH SEMINARS AND WE WILL TALK ABOUT THE WEBINARS AND WE WILL TALK ABOUT INFORMED CONSENT. WE WANT THE PATIENTS TO UNDERSTAND SO IF THEY WANT ENGAGEMENT AND MANY DO, BETWEEN ALL THE NEW DEVICES THAT ARE COMING OUT, THE NEW DRUGS THAT ARE COMING OUT, PATIENTS ARE V, VERY, VERY INTERESTED IN GETTEN GAUGED IN DIFFERENT CLINICAL TRIALS BUT THE CHALLENGE IS TO FIND WHAT I CALL A GOOD FIT BETWEEN THE PATIENT AND WHAT THEY'RE LOOKING FOR AND THE PARTICULAR CLINTAL TRIAL THAT MAY BE AVAILABLE. SO WE NEED TO BE ABLE TO PROPERLY ARTICULATE IT TO THEM. WE HAVE RENAL LIFE AND MAG ZONE WE SENT OUT. WE PUT THIS MAGAZINE, 6000 CENTERS, DIALYSIS PLACES, OTHER PLACES, KID ME BEGINNINGS, WHICH THOSE WHO ARE NEW TO CKD AND THOSE WHO ARE NEW TO DIALYSIS, AGAIN WHAT I CALL THE HEALTHCARE CONTINUUM, YOU HAVE OPPORTUNITIES TO FOR CLINICAL TRIALS AND IT'S IMPORTANT WE EDUCATE THE PATIENTS SO THAT WHEN THEY'RE LOOKING AT THAT INFORMED CONSENT AND THEY--JUST BECAUSE THEY SIGN IT DOESN'T MEAN THEY UNDERSTAND IT. AND JUST BECAUSE THEY SIGN IT DOESN'T MEAN THEY WILL ADHERE TO IT SO THOSE ARE THINGS WE NEED TO TAKE A LOOK AT AND JUST KEY ONGOING TRENDS. THINGS WE LOOK AT, PROPOSED NEW OFFICE OF PATIENT INN GAUGE. MY SLIDE'S A BIT DATED BECAUSE THAT IS THE PATIENT ADVISORY ENGAGEMENT COUNSEL THAT MY COLLEAGUE IS CHAIR OF. A LOT OF THESE DISPARITIES AND KIDNEY RESEARCH, THERE'S A GAO REPORT THAT CAME OUT IN JANUARY THAT TALKED ABOUT THE LACK OF INVESTMENT THAT'S BEING DONE IN KIDNEY RELATED RESEARCH AND THE NUMBER OF AMERICANS THAT HAS AN IMPACT ON IS SIGNIFICANT. SO I KNOW I'M PAINTING KIND OF A BROADER PICTURE HERE BUT A LOT OF IT BOILS DOWN TO AS WE MOVE TO TRY GET MORE PATIENTS ENGAGED SUCCESSFULLY IN CLINICAL TRIALS, WE ARE GOING IT NEED TO DO A BETTER JOB OF A-EDUCATING PATIENTS, B- ON THE KPMP PROJECT, IT BECAME THREER THERE WERE A NUMBER OF RESEARCHERS WHO NEVER HAD ANY INTERACTION WITH PATIENTS AND THEY WEREN'T NECESSARILY COMFORTABLE AROUND THE PATIENTS. THAT WAS CLEAR ALSO. SO WE SPENT SOMETIME HAVING JUST SOME SESSIONS WHERE PEOPLE GOT A CHANCE TO SIT DOWN AND KNOW EACH OTHER. WE'RE ACTUALLY DOING PRIMMERS ON THE DIFFERENT ASPECTS OF THEM. I SUGGEST THEY DO A PRIMER ON IRB, WHAT IS THAT? PATIENTS HEAR THAT BUT THEY DON'T KNOW WHAT THAT IS? SO WE HAD PEOPLE COME OUT CAN DO WEBINARS, TALK ABOUT THAT, WOO PUT THEM UP ON THE WEBSITE. WE SAID LET'S POST THEM ON A WEBSITE SO PEOPLE LIKE ME CAN GO AND LOOK AT IT 2 OR 3 TIMES AND I DON'T MIND ASKING THOSE QUESTIONS, SOME OF THE OTHER PEOPLE MAY BE UNCOMFORTABLE ABOUT THAT, BUT INVARIABLY THE PATIENTS HAVE WALKED UP AND SAID, I AM GLAD YOU ASKED THAT QUESTION BECAUSE I WANT TO LOOK AT IT MY OWN PACE. I SAID I UNDERSTAND I NEED TO LOOK AT IT ON MY OWN PACE TOO, SO IF IT'S ON A WEBSITE CAN YOU LOOK AT IT AT YOUR OWN PACE AND MAKE SENSE OF IT, THAT WILL DO A WHOLE LOT MORE FOR YOU. I WILL SEE IF I CAN CLICK IN THE RIGHT DIRECTION THIS TIME. ALL RIGHT. AND WE DO HAVE, AS AN ORGANIZATIONSIZATION, CENTER FOR PATIENT ENGAGEMENT, AND I WANT TO PUT THE OTHER 1 UP, WE HAVE THE CENTER FOR PATIENT RESEARCH WHERE WE HAVE THE PATIENTS GETTING MORE AND MORE INVOLVED IN RESEARCH AND WE SET THAT UP AS WE GO OUT AND WE TALK WITH DIFFERENT COMPANIES, RAN INTO A COMPANY THE OTHER DAY, WE HAD KIDNEY WEEK AND THEY WERE TALKING ABOUT A PRODUCT THAT THEY HAD FORGOT AND I SAID TO MYSELF AND MY COLLEAGUE, WE SUFFER FROM THAT. HE SAID SERIOUSLY. I SAID YEAH THERE'S 8 MILLION RENAL PATIENT WHO IS SUFFER FROM GOUT. SO THEY HAVE SENSE ENGEAJED US TO TALK WITH THEM AND HELP THEM COME UP WITH A TOOL THAT THEY CAN USE TO MARKET THAT IN THIS PARTICULAR MARKET AND IT'S A TREMENDOUS PARTICULAR PRODUCT. AND I SUGGESTED THAT THEY GO BACK AND REVAMP SOME OF THE CLINICAL TRIALS THEY'RE DOING. SO THEY CAN HAVE MORE COMPREHENSIVE GROUP AND THEY WERE LOOKING AT WHAT THEY WERE THINKING ABOUT, THE MARKET THAT WE GAVE THEM IS MUCH BROADER THAN WHAT THEY HAD INITIALLY THOUGHT OF, SO AS A PATIENT ORGANIZATION, I WOULD SUGGEST THIS TO FOLKS, WHEN WE COME OUT, WE DON'T SEND OUT STAFFERS TO SPEAK FOR THE PATIENTS, WE SPEND OUT PATIENTS TO SPEAK FOR THEMSELVES AND NOT THAT WE AGROW ON EVERYTHING, BUT I THINK THAT THAT IS VERY HELPFUL AND WE SPEND A LOT OF TIME EDUCATING OURSELVES, SO THAT WE'RE IN A POSITION TO DO THAT AND WE CANADAD VALUE TO A DISCUSSION. THIS IS THE LAST 1, THIS HAPPENS TO BE--WE GREW UP ON AT THE WHITE HOUSE SUMMIT ON ORGAN TRANSPLANTATION WHICH IS A REAL BIG AREA. THAT'S PAROVER THERE TO THE LEFT, THAT-OF WITH THE PRESIDENT, AND THAT'S ME, FAT HEAD OVER THERE, AND WE WERE JUST TALKING WITH THEM AND APPLAUDING THE CELL ASSISTANCE HE WOULD DO THAT. SO I WILL STOP THERE. AND JOIN MY COLLEAGUES IF YOU HAVE SOME QUESTIONS. BY THE WAY I APPRECIATE YOU HAVING ME COME OUT AND SPEAK WITH YOU TODAY. I ALWAYS LIKE THE OPPORTUNITY TO SHARE INFORMATION AND TO LEARN. I CERTAINLY WANT TO LEARN MORE ABOUT WHAT'S GOING ON FROM THINGS FROM THE CANCER, THERE'S A LOT OF OVERLAP BETWEEN THE INFORMED CONSENT PROCESS HERE THAT WHICH WE'RE GOING THROUGH. SO I WILL TURN THIS BACK OVER TO YOU. >> THANK YOU VERY MUCH. [ APPLAUSE ] >> AND JANE AND DIANA, WILL YOU COME BACK TO THE TABLE AND WE CAN HOPE IT UP TO QUESTIONS. I HAVE TO SAY I WAS STRUCK BY ALL OF YOUR PRESENTATIONS BUT ABOUT THE ENORMOUS REALLY GULF BETWEEN PATIENTS AND PARTICIPANTS, RESEARCHERS, DOCTORS, ALL OF THOSE GROUPS AND HOW REALLY WHAT A CHALLENGE WE FACE TRYING TO BRIDGE THOSE WITH EITHER EITHER DOCUMENTS OR CONVERSATIONS BETWEEN THE EDUCATION DIFFERENCES AND WHAT WE UNDERSTAND, SO, SO WE'RE DOING THE BEST WE CAN. AT ANY HELP WE CAN GET IS OBVIOUSLY MUCH NEEDED. SO QUESTIONS FOR THE GROUP OR FOR ANY OF THE PRESENTERS? JONATHAN? >> THANK YOU ALL FOR YOUR PRESENTATIONS, I REALLY GOT A LOT OUT OF IT, SO 1 THING THAT OCCURRED TO ME AND LISTENING TO ALL OF YOU IS WHETHER OR NOT, IN THINKING ABOUT THE INFORMATION, WE NEED TO TAKE A STEP EVEN FURTHER BACK THAT WHAT WE'VE BEEN TALKING ABOUT UP TO NOW IN TERMS OF TRIAL SPECIFIC INFORMATION. AND DO WE NEED TO THINK, WOULD KEY INFORMATION ENCOMPASS THAT A PARTICIPANT MIGHT WANT TO KNOW VERY BASIC THINGS ON EDUCATING ON THE DRVES OF BEING IN A CLINICAL TRIAL THAN GETTING CARE FROM YOUR DOCTOR SUCH AS YOUR DOCTORS GOING TO BE SPECIFIC ABOUT ADJUSTING DOSES FOR YOU, IT WILL TAYLOR TECHNOLOGY TRANSFERS WHEREAS IN A CLINICAL TRIAL, YOU ARE IN A FOLLOW UP PROTOCOL. ET CETERA. MY SENSE WOULD BE THAT I THOUGHT ABOUT THIS BEFORE AND OFTEN, WE ALMOST NEED A PRECONSENT BEFORE WE EVEN TALK ABOUT A SPECIFIC STUDY, WE NEED TO EDUCATE PEOPLE AS TO THE FUNDAMENTAL DIFFERENCES OF RESEARCH. BUT I MEAN I WONDER IF WE COULD EVEN THINK ABOUT INCORPORATING--THAT GETS TO THIS FRAMING TOOL WE TALKED ABOUT IN THE SUBCOMMITTEE WHETHER WE COULD INCORPORATE PARTS OF THAT SO PEOPLE HAVE A BETTER UNDERSTANDING OF HOW BEING IN A CLINICAL TRIAL WILL AFFAIRS TEAM AFFAIRS T EAM--ALTER THEIR RELATIONSHIP WITH THEIR DOCTOR AND HOW THEIR CARE IS DELIVERED IF YOU HAVE ANY THOUGHTS ON THAT? >> SO WHAT COMES TO MIND IMMEDIATELY, IS THAT PEOPLE--YOU KNOW THE DISCUSSION OF A CLENICAL INFORMED CONSENT HAS BEEN BANTIED ABOUT OVER THE YEARS AND SOMETHING I BELIEVE IN. WHEN YOU READ INFORMED CONSENT AND IT SAYS, YOU WILL BE RESPONSIBLE--I DON'T MEAN TO FOCUS ON THE MONEY BUT IT SAYS YOU WILL BE RESPONSIBLE FOR ALL RESEARCH PROCEDURES YET, YOU KNOW STANDARD OF CARE PROCEDURES WILL BE BILLED TO YOUR INSURANCE AND YOU WILL BE RESPONSIBLE FOR ANY ADDITIONAL PAYMENTS, RIGHT? , YOU DON'T EVEN KNOW WATHAT--THE NORMAL OR USUAL CARE IS NECESSARILY. MAYBE YOU DO, MAYBE YOU'RE A VERY EXPERIENCED PATIENT BUT YEAH, I MEAN THAT'S SOMETHING--WELL THAT ALSO BRINGS UP THE WHOLE DISCUSSION OF GUIDELINES AND WHICH SET OF GUIDELINES YOU WILL GO BY, RIGHT AND SOMETHING THAT BRIAN TOUCHED UPON EARLIER. I THINK WITH HIS GUIDELINE WORK. BUT YEAH IF YOU HAVE--YOU DON'T HAVE A REAL UNDERSTANDING OF WHAT THE USUAL CARE IS, IT'S VERY HARD TO MAKE THAT INFORMED CONSENT. >> SO I THINK WHERE YOU'RE COMING, JONATHAN IS NOT TOTALLY SEPARATE FROM SOME OF THE THINGS I WAS ADVOCATING ALTHOUGH I WOULD NOT SAY THAT WE NEED STILL 1 MORE LEVEL, IN PART BECAUSE IN CLIN KALG TRIALS, THOSE DIFFERENCES AND SIMILARITIES WITH CLINICAL CARE VARY QUITE A BIT WITH THE TYPE OF TRIAL. BUT I WOULD TRY TO MAKE THE PREAMBLE, INCLUDE ENOUGH OF THAT INFORMATION AS WELL, BUT REALLY SPECIFIC TO THE TRIAL AND SOME OF THE VERY SPECIFIC THINGS THAT I THINK SOME OF THE PEOPLE WERE AIMING FOR LIKE SPECIFIC RISKS. I WOULD LEAVE THOSE TO THE INFORMED CONSENT. SO I THINK A LOT OF THE THINGS YOU ARE MENTIONING ARE IMPORTANT TO HAVE SOME PLACE UP THERE, BUT I DON'T KNOW THAT HAVING A SEPARATE TEAR OR DOCUMENT FOR THEM IS NECESSARY. AND MANY ORGANIZATIONS ACTUALLY HAVE PAMPHLETS, NCI HAS A PAMPHLET, AND NIH AS A PAMPHLET ON CLINICAL RESEARCH AND MANY PLACES THAT DO A LOT OF TRIALS HAND THAT OUT. >> I AGREE WITH MY COLLEAGUES AND I WOULD JUST ADD THAT CERTAINLY, THERE'S NO 1 SIZE ONE-SIZE-FITS-ALL HERE AND I DO THINK THAT AGAIN, YOU ARE GOING TO HAVE PATIENTS THAT HAVE VARYING LEVELS OF DEGREE OF UNDERSTANDING OF WHAT THEY'RE GETTING INVOLVED IN. I THINK THAT AGAIN, THE OVERALL PATIENT POPULATION, IT WOULD BE GOOD FOR THEM TO GET EXPOSURE AND UNDERSTAND ENOUGH CLINICAL TRIALS BEFORE HAND BUT ANY INSTANCES THAT THEY CAN, POINTING OUT THE DIFFERENCE--I KNOW A LOT OF RENAL PATIENTS THE NEFFROLOGYST WOULD SAY LISTEN YOU STILL NEED TO GO SEE YOUR PRIMARY CARE PHYSICIAN, I'M DEALING WITH YOUR KIDNEY RELATED ISSUES BUT I STILL NEED TO GO SEE YOUR PRIMARY CARE PHYSICIAN, MOST OF THEM DON'T INCLUDING MYSELF, BUT I THINK THAT IS IMPORTANT TO EXPLAIN IT TO THEM SO THAT THEY HAVE SOME TYPE OF UNDERSTANDING AND CLARIFICATION AND THE REALITY ISA THAT IF YOU EXPLAIN SOMETHING TO SOMEONE AND THEN THEY GET STARTED THEY MAY HAVE THAT EPIPHANY WHERE THEY ALL OF A SUDDEN UNDERSTAND WHAT YOU'RE TALKING ABOUT, AFTER THE FACT WHEN THEY MOVE ON THE CORRIDOR OF BEING ABLE TO COMPREHEND AND UNDERSTAND WHAT'S GOING ON. >> SO WITH APOLOGIES TO RICHARD, THE CONTEXT OF THIS SESSION TODAY IS TO GIVE GUIDANCE ON SATISFYING A NEW REQUIREMENT IN THE REGULATIONS FOR THIS KEY INFORMATION SUMMARY. SO I THINK THE POINTS YOU'VE ALL MADE ABOUT ALL OF THE ISSUES AROUND PATIENT ENGAGEMENT AND HOW WE ARE NOT ALWAYS FULFILLING OUR ROLES OR OUR RESPONSIBILITIES TO PARTICIPANTS AND PATIENTS ARE VERY IMPORTANT. I'D LIKE AND I THINK JANE HAS PROBABLY ACTUALLY ANSWERED THIS IN HER PRESENTATION BUT FOR ALL OF YOU TO MAKE 3 SUGGESTIONS, CONCRETE SUGGESTIONS FOR WHAT WE SHOULD DO WITH THE KEY INFORMATION SUMMARY TO HELP IT SERVE POTENTIAL PARTIC PLAN TO ANALYZE BY PANTS OF OF--PARTICIPANTS. >> WELL I'LL GO. AGAIN, CLARITY OF INFORMATION. SO IF THERE'S WORDS, SHE HAD A GREAT EXAMPLE UP THERE WHERE YOU CAN MAKE SOMETHING EASIER TO UNDERSTAND, I THINK THAT THAT'S IMPORTANT. KEY INFORMATION, OBVIOUSLY RISK IS ALWAYS IMPORTANT TO BE ABLE TO--SOME PEOPLE ARE NOT COMFORTABLE WITH NUMBERS, I ALWAYS SAY WELL WHAT'S THE CHANCE THAT WE COULD DIE FROM THIS? AND I THINK THAT NEEDS TO BE MADE CLEAR TO FOLKS, HOWEVER YOU WANT TO ARTICULATE IT. AND I THOUGHT THE DOCUMENTS WERE GOOD. I READ THE SUMMARY OF THE KEY INFORMATION, I THOUGHT IT WAS GOOD AND AGREED TO IT. I THOUGHT THAT 1 PAGE SUMMARY MIGHT HELP. I'M A SUMMARY GUY, I WOULD LIKE TO SEE THAT BUT OTHERWISE I THOUGHT IT WAS VERY GOOD. >> THANK YOU. JANE? >> WELL WELL, LET'S SAY THAT I TRIED TO INCORPORATE THAT. I WOULD SAY SOME VERY CONCRETE EXAMPLES AND SOME ACTUAL TEMPLATE LANGUAGE THAT COULD BE PUT IN OR MODIFIED OF THE SORT THAT I THINK STEPHEN HAD PRESENTED, HIGH LEVEL OF--TO GIVE PEOPLE A SENSE OF WHAT MIGHT GO IN THE KEY INFORMATION AND I THINK, IT MIGHT NOT BE THE TASK BUT ACTUALLY SEPARATING OUT WHAT'S IN THE KEY INFORMATION VERSUS LATER WITH EXAMPLES OF EACH COULD BE REALLY HELPFUL BECAUSE I DON'T KNOW IF THERE'S ANOTHER GROUP THAT'S WORKING ON THE REST OF THE CONSENT BUT THAT'S PROBABLY WHERE MORE WORK NEEDS TO BE DONE AND MAYBE GIVING PEOPLE A SENSE OF WHETHER THIS IS LIKELY TO BE A 1 OR 2 PAGE OR 6 PAGES. AND I THINK THAT THE GROUP REALLY FELT AS THOUGH THEY COULD COULDN'T COME TO CONSENSUS ON THAT BUT MAYBE SOMEBODY CAN. >> THANK YOU. DIANA,? >> STEPHEN, I APOLOGIZE, I CAN GET IT DOWN TO 3. I CAN GET IT DOWN TO 5. COMP REHENGSZ IS KEY. USING LAY TERMS, MAKING, SIMPLIFYING COMPLEX MEDICAL TERMINOLOGY. YOU KNOW YOU, LUKE AT 1 PLACE YOU HAVE STOMACH CANCER, ANOTHER YOU HAVE GASTRIC CANCER WHICH DO I HAVE RIGHT? SO, PUTTING THINGS, MAYBE HAVING GLOSSARY, MAYBE THAT COMES IN THE APPENDIX, I DON'T KNOW BUT I SEE PATIENTS GRAPPLE WITH THAT A LOT BECAUSE SOME CONDITIONS, EVEN SOME CONDITIONS CAN BE VERY, VERY COMPLICATED. I THINK YOU HAVE TO DESCRIBE THE INTERVENTION AND YOU HAVE TO INDICATE TREATMENT DURATION AND STUDY DURATION IF THEY ARE DIFFERENT THINGS. >> SO YOU'VE ALL SEEN THE DOCK UPS WHICH COVER A LOT. THERE'S FAR MORE IN THOSE DOCK YOU WANTS THAN WOULD REASONABLY END UP IN A SET OF RECOMMENDATIONS BUT THEY'RE WRITTEN FROM OUR PERSPECTIVE FROM YOUR PERSPECTIVE, FROM THE PARTICIPANT PERSPECTIVE AND THE PATIENT ADVOCATE PERSPECTIVE, IS THERE SOMETHING ACKNOWLEDGING THAT WE NEED TO WRITE THINGS IN LANGUAGE THAT NEEDS TO BE ACCESSIBLE AND FRAMED IN A CERTAIN WAY? IS THERE ANYTHING WE MISSED? THAT WE WOULDN'T HAVE THOUGHT OF THAT'S PARTICULARLY IMPORTANT TO THE GROUPS YOU REPRESENT? >> YOU KNOW I THINK A LOT OF THINGS CAME UP IN THE DISCUSSION AND I THINK THE STATEMENT THAT SAYS WE SHOULD BE FLEXIBLE, NOT ALL OF THESE HAVE TO BE IN EVERY 1 AND OTHERS MIGHT BE AND OTHERS IS WHAT WE SHOULD BE SAYING AND IF YOU WANT TO ADD A FEW OF THE THINGS THAT HAVE COME UP IN THE DISCUSSION AS POSSIBLE ADDITIONAL THINGS, FINE, BUT I DON'T THINK THERE'S ANYTHING THAT WAS TOTALLY MISSED THAT NEEDS TO BE IN EVERYTHING. I DON'T THINK ANYONE--YOU KNOW A LOT OF PEOPLE RAISE THINGS IN THE MORNING AND I SAY OH THAT'S' A GOOD IDEA BUT I DON'T THINK YOU HAVE TO ADD THAT TO THE ABSOLUTES. GOOD JOB. >> THANK YOU. OTHER QUESTIONS FOR THE PANEL? >> YOU MENTIONED GROUPS THAT COULD BE VERY HELPFUL BUT 1 GROUP THAT WASN'T ON THERE THAT I WAS WONDERING ABOUT ARE FAMILIES OF PATIENTS SENSE THEY SEEM TO BE THE PEOPLE WHO MIGHT BE THE DEEP READERS OF THE INFORMED CONSENT, YOU DIDN'T INTENTIONALLY LEAVE THEM OFF THE LIST OR DO YOU THINK OF THEM AS PATIENT ADVOCATES OR ARE THEY PEOPLE THAT PERHAPS WOULD HAVE SOMETHING TO SAY ABOUT THESE? >> PERHAPS A GENERIC PERSPECTIVE THERE BUT WE ALWAYS TALK ABOUT PATIENTS AND CAREGIVERS OR FAMILY MEMBERS, THAT'S--WE INCLUDE THAT WHEN WE SPEAK REGARD TO PATES, YOU KNOW? --PATIENTS, YOU KNOW? THEY HAVE SOMETHING DONE, THEY HAVE SOMEBODY DRIVE THEM THERE AND TAKE THEM BACK AND YOU KNOW A LOT OF TIMES HELP TRANSLATE THE INFORMATION SO CERTAINLY. VERY IMPORTANT. AND AGAIN, WE HAVE THEM COME IN AND THEY CAN EDUCATE IT AS WELL. THAT'S A BIG PART OF IT. GOOD QUESTION, THANK YOU FOR CLARIFYING THAT. >> SANDY, AS SOMEBODY WHO ADVOCATED, I HAVE TO ADVOCATE FOR MY BROTHER WHEN HE GOT DIAGNOSED WITH STAGE 4 ESOPHAGEAL CANCER AND THIS WAS A COUPLE YEARS AGO AND HE ENDED UP IN A CLINICAL TRIAL, I HELPED HIM. I HELPED NAVIGATE FINDING CLINICAL TRIALS AND THE WHOLE THING, BUT YOU KNOW IT WAS VERY AMUSING TO ME WHEN HE WAS HAVING SIDE EFFECTS FROM THE INVESTIGATIONAL AGENT AND I SAID WELL LET'S LOOK IT UP IN THE INFORMED CONSENT, IT'S LIKE, IT'S BACK FROM IN A BOX, YOU KNOW IT WAS VERY AMUSING TO ME, THAT GETTING THROUGH THAT THING IS SOMETHINGEE HE WASN'T PREPARED TO DO. >> OH YEAH. >> OTHER QUESTIONS? SO THANK YOU AGAIN. I WOULD ASK THAT YOU STAY ENGAGED. SO I ANTICIPATE THAT 1 OF THE OUTCOMES OF ALL OF THIS IS GOING TO BE EXPLICIT ACKNOWLEDGMENT THAT WE DON'T HAVE ALL THE ANSWERS NOW. AND THAT THIS IS, YOU KNOW WHETHER THROUGH POSTING OF CONSENTS THROUGH SHARING, YOU KNOW THE INFORMATION ABOUT RISKS AND SIDE EFFECTS AND THEY KDZ BE REUSED. WHETHER IT'S JUST THROUGH EXPERIENCE, WE'RE GOING TO NEED TO LEARN HOW TO DO THIS RIGHT. AND I THINK YOU REPRESENT PROBABLY THE MOST IMPORTANT VOICES IN THE CONVERSATION FOR IT PARTICULAR ITEM. SO I WOULD LIKE TO INVITE YOU PERSONALLY AND ON BEHALF OF YOUR ORGANIZEINIZATIONS,--ORGANIZATIO NS TO STAY INVOLVED WITH THIS. I DON'T KNOW WHAT THAT MEANS. BUT LOOK FOR IT. WHEN QUESTIONS ARE ASKED OR THINGS ARE OUT FOR PUBLIC COMMENT, PLEASE FEEL FREE TO PARTICIPATE AS MUCH AS YOU CAN. THANK YOU ALL. >> WELL, THANK YOU ALL BECAUSE THIS IS REALLY TOUGH WORK AND PEOPLE COUNT ON IT. >> ABSOLUTELY, I AGREE. I WANT TO THANK YOU FOR THE WORK THAT YOU DO BECAUSE YOU ARE MAKING DIFFERENCES IN THE LIVES OF PATIENTS BUT WE ARE TRYING TO HELP FINE TUNE THE PROCESS BUT WE APPRECIATE ALL THAT YOU DO. >> [INDISCERNIBLE]. >> THANK YOU. [ APPLAUSE ] >> AND I HAVE ANOTHER CALL AT 3, SO IF I LEAVE SHORTLY PLEASE DON'T TAKE IT PERSONALLY. >> THANK YOU. >> YEAH, IT'S TRUE. SO WHY DON'T WE GO INTO THE--I WAS DEBATING WHETHER TO CALL FOR A BREAK OR NOT BUT I REALLY AFTER THIS MORNING, I'M REALLY NOT SURE HOW TO ANTICIPATE HOW MUCH MORE DISCUSSION WE WILL HAVE AROUND REVISITING THE DOCUMENT AND THE QUESTIONS WE RAISE SO I THINK WE SHOULD KEEP GOING. DAVID DO YOU WANT TO--I DON'T KNOW--WE--WE TALKED ABOUT EXPLICITLY REVISITING THE DOCUM, IF YOU COULD JUST PUT IT UP THERE TO REMIND PEOPLE AND THEN WE'LL OPEN THE DISCUSSION. >> I THINK 1 OF OUR COMMITMENTS WAS TO COME BACK TO THIS ONCE WE HEARD ALL VOICES. HOLLY? >> YOU KNOW THE THOUGHT OCCURS TO ME THAT 1 OF THE THINGS THAT WILL BE MOST VALUABLE HEARING FROM PATIENTS, ADVOCATES AND FAMILIES IS ONCEY WE HAVE EXAMPLES THAT WE DEVELOP, IT'S HARD TO REACT TO A DOCUMENT LIKE THIS, I THINK IT'S HARD FOR US TO REACT TO A DOCUMENT LIKE THIS AND ONCE WE USE THESE TOOLS WHICHEVER THAT WE DECIDE UPON TO CREATE SOMETHING, THAT WILL BE ANOTHER VERY EXPLICIT POINT IN TIME TO SAY, TO JANE AND DAN AND OTHERS, HOW DOES THIS LOOK TO YOU? WHAT HAVE WE MISSED? WHAT ELSE NEEDS TO BE INCLUDED. THOSE TYPES OF QUESTIONS. DOES THAT SOUND RIGHT TO YOU? IT'S EASIER TO REACT TO SOMETHING. >> WELL, YOU KNOW, I LOOLD TOIK FOLLOW UP ON THAT BECAUSE WHAT IT SOUNDS LIKE YOU JUDGE JUST SAID HOLLY IS WHEN WE GET A BETTERRITY RAIGDZ AND NARROW DOWN LIKE WHAT TOOLS WE THINK ARE THE BEST 1S AND STUFF, THEN WE SHOULD DO THE EXERCISE OF TRYING OUR HAND AT THIS, WHICH JONATHAN DID ON THE NCI FORM BUT THAT 1'S BEEN DONE TO DEATH AND SO I WAS THINKING THAT NOW WE NEED TO PICK ANYONE BUT I'M ALSO THINKING THAT IF WE--IF WE HAD SOME HOMEWORK THAT WHERE WE WERE WORKING ON ANOTHER PROTOCOL AND CONSENT FORM, IF EACH OF US TRIED DOING IT MIGHT HELP US GET A BETTER WORKING SENSE WHEN WE LOOK AT WHAT WE'VE GOT OF WHICH TOOLS WE FOUND MOST USEFUL AND WHICH APPROACHES WE THOUGHT MADE THE MOST SENSE. SO I WOULDN'T WAIT UNTIL WE HAD ANOTHER ITERATION OF THIS DOCUMENT TO COME UP WITH SOME EXAMPLES. >> SO DAVID I DON'T REMEMBER IF THE DOCUMENT EXPLICITLY ACKNOWLEDGES THAT THIS WILL REMANY A WORK IN PROGRESS AFTER WE ISSUE OUR RECOMMENDATION? AND WITH THE-- >> WE HAVE THIS SECTION--THE CLOSEST WE GET IS THIS SECTION, LINE 72-77 TALKS ABOUT THERE WILL BE IMPERICAL RESEARCH BEFORE AND AFTER IMPLEMENTATION, THEY WILL BE DETERMINED HOW TO USE IT, AND WE CAN ENHANCE THAT A BIT TO SAY, MORE EMPHASIS ON CONTINUING RESEARCH. >> SO OBVIOUSLY PEOPLE LOOK TO SACHRP RECOMMENDATIONS AS ADVISING AS TO COMPLIANCE AMONG OTHER THINGS. SHOULD WE ADD TO THAT PARAGRAPH THE SUGGESTION THAT OHRP TAKE THIS INTO ACCOUNT IN ITS REVIEW OF CONSENT FORMS FOR, YOU KNOW, IT'S REVIEW OF COMPLIANCE OR ANY AGENCIES TAKE THIS INTO ACCOUNT REVIEW AND COMPLIANCE. I--YOU KNOW WE HAD SOME CONVERSATIONS OVER THE BREAK AND THERE ARE CLEARLY THINGS THAT NEED--THAT ARE KEY INFORMATION AND NO 1 WOULD ARGUE WITH, THERE ARE OTHERS THAT WE'RE STILL FIGURING OUT. SO, YOU KNOW YOU CAN--YOU CAN ENVISAGE A SITUATION IN WHICH LEAVING SOMETHING OUT WHICH IS KEY INFORMATION WOULD BE A COMPLIANCE ISSUE. ON THE OTHER HAND THERE'S A WHOLE BUNCH OF GRAY STUFF THAT YOU WOULDN'T WANT PEOPLE TO TAKE THE 5 ELEMENTS OR LISTS WE PROVIDED AND CONSIDER THEM AS RECOMMENDATIONS TO COMPLIANCE. I'M NOT SURE HOW TO PUT THIS BUT I THINK IT MIGHT BEAR ACKNOWLEDGING THAT THIS IS NOT A--WELL, IT'S NOT A COMPLIANCE EXERCISE OR COMPLIANCE FLEXIBILITY, IT WOULD BE RECOMMENDED IN THE EARLY STAGES OF THIS. I DON'T EVEN KNOW IF THAT HAS ANY MEANING IN THESE PERSPECTIVES. >> I GUESS I THINK AS A GENERAL MATTER THE WAY WE FUNCTION AND THE FACT IF WE'RE COMING OUT WITH, YOU KNOW NEW GUIDANCE ON A BRAND NEW REGULATION, WE CLEARLY WOULD DO THAT. IT'S INAPPROPRIATE IF THINGS ARE GRAYED TO PENNALLIZE PEOPLE FOR VIOLATING A RULE WHEN THE RULE IS GRAY AS TO WHETHER OR NOT YOU ARE REQUIRED TO DO THIS. BUT WE CERTAINLY, CERTAINLY REASONABLE FOR YOU TO STATE SOMETHING LIKE THAT. >> I'M NOT CONCERNED ABOUT WHAT YOU WOULD DO, I'M CONCERNED ABOUT WHAT PEOPLE WILL BE AFRAID YOU WILL DO. THE OTHER POINT I BROUGHT UP AT THE BREAK IS THAT THERE'S A CONSENT FORM FOR A PARTICULAR STUDY OR PREPONDERANCULATION AND THAT IS ABSOLUTELY TRUE NOW AND IS REALLY KIND OF OUTSIDE THE SCOPE OF KEY INFORMATION BUT I THINK WE DO NEED TO ACKNOWLEDGE THAT 1 SOLUTION TO SOME OF THESE PROBLEMS WOULD BE IN FACT TO HAVE DIFFERENT CONSENT FORMS FOR DIFFERENT POPULATIONS IF THEY WERE DEFINED IN THE STUDY AND I DON'T MEAN RMA OR RMB, PHASE 1, 2, AND 3. BUT ACTUALLY IF YOU COULD ANTICIPATE PEOPLE COMING IN, 2 POPULATIONS OF PEOPLE BEING ENROLLED WHETHER THERE SHOULD BE DIFFERENT. SO THAT'S NOT WITHIN OUR SCOPE TODAY, BUT IT'S SOMETHING TO THINK ABOUT AND SOMETHING JUST TO KEEP IN MIND WE ASSUME IT BUT IT'S NOT WRITTEN ANYWHERE. >> IT'S INTERESTING BECAUSE WE READ, RIGHT, TEXT, ALL THE TIME BUT LOOKING AT SOME OF THE GRAFS, THE DIFFERENT LAY OUTS OF THE CONSENTS SHOWN BY THE PREVIOUS PRESENTERS WAS LIKE GOING ON A VACATION, RIGHT? IT WAS ALL LAID OUT SO NICELY. SO THAT DOES BRING US UP TO SOMETHING MENTIONED BEFORE, BRIAN BROUGHT UP AND HE SAID WE'RE DOING ALL TEXT HERE AND GRAPHICAL DISPLAYS FOR NUMERACY ISSUES BUT I THINK FOR OTHER THINGS, TOO AND CERTAINLY FOR FLOW AND OTHER THINGS, I DON'T KNOW HOW WE WOULD COME UP. THAT'S SUCH A--FOR 1 OF A BETTER WORD UNDISCIPLINED AREA, I'M NOT SURE HOW TO MAKE A STRONG RECOMMENDATION, I THINK THERE IS SOME RESEARCH, BUT I'M NOT FAMILIAR WITH IT. ABOUT THE BEST WAY TO REPRESENT THINGS BUT THAT'S ANOTHER AREA IN WHICH WE NEED TO BE OPEN AND I THINK THIS WAS JANE MENTIONED, YOU KNOW SHE DIDN'T CARE ABOUT LENGTHS, SHE WANTED BIG FONTS AND LOTS OF WHITE SPACE, THAT'S ALSO SOMETHING WE NEED TO TAKE INTO ACCOUNT. THE REGULATION IS SPECIFICALLY TO MAKE SURE THIS IS UNDERSTANDABLE AND I THINK THOSE MEASURES WHICH WE HAVEN'T TALKED ABOUT, CERTAINLY CAN ADD TO ACCESSIBILITY AND UNDERSTANDABILITY. WHAT ELSE DID WE LEAVE OVER FROM THIS MORNING? SO I'LL CALL ON EXOFFICIOS, FROM FDA AND NIH FOR COMMENTS FROM THEIR PERSPECTIVE. >> CAN I COMMENT FOR MYSELF BECAUSE I HAVEN'T AT ALL MENTIONED THIS TO ANY OF MY COLLEAGUES, I'M STRUGGLING WITH THE DEFINITION OF CLINICAL TRIAL SAYS, PEOPLE ARE PROSPECTIVELY ASSIGNED TO 1 INTERVENTION OR ANOTHER AND WE'RE LOOKING AT THE EFFECT OF THAT INTERVENTION ON A BIOMEDICAL OUTCOME. IN MY MIND, MAYBE IT'S BECAUSE I'M COMING FROM FDA, I'M THINKING OF SOMETHING THAT'S UNDER AN IND OR IDE IN A HIGHER RISK CLINICAL TRIAL AND THEN WHEN RESLY RAISED THE QUESTION ABOUT WHAT DO YOU MEAN WHEN YOU SAY A MINIMAL RISK OR LOW RISK TRIAL, IN THAT'S LOW RISK IT'S NOT KEY INFORMATION, IS THAT EVEN THE KIND OF TRIAL THAT WE WANT TO REQUIRE KEY INFORMATION FOR. I MEAN I HATE TO THROW THAT OUT IN THE MIDDLE OF ALL THIS BECAUSE IT'S A SCOPE ISSUE, I JUST FEEL LIKE IF YOU HAVE A LOWER RISK TRIAL, AND YOU USE THE EXAMPLE DAVID OF 2 LITTLE DEVICES, DO WE NEED KEY INFORMATION FOR THAT OR IS THAT GOING TO BE A SIMPLE ENOUGH INFORMED CONSENT DOCUMENT THAT YOU WOULD NEED TO BRING THAT UP BECAUSE EVERY TRIAL WE'RE TALKING ABOUT IS, HIV, DEPRESSION, CANCER, YOU KNOW-- >> THE RISK OF COMPLIANCE HAT ON AND SAY DO I HAVE AS AN IRB HAVE THE LATITUDE TO NOT HAVE A KEY INFORMATION BECAUSE IT'S MINIMAL RISK, I DON'T READ THAT IN THERE. >> WELL IF IT SAYS THE EFFECT OF THE INTERVENTION ON A BIOMEDICAL OUTCOME. >> WELL WHAT IF IT'S 1 OF THESE SKIN THINGS THAT MAKES YOUR HAIR OR FACE LOOK BETTER, MINIMAL RISK OR LASERS, YOU KNOW? >> YEAH, WELL, A LASER THOUGH, I'M NOT CONSIDERING THAT TO BE LOW RISK ESPECIALLY ON THE FACE, IF IT'S A BAND-AID COMPARING TO BAND-AIDS, AS A COMPLIANCE PERSON, I WOULD HAVE TO KIND OF LOOK AT THE REG AND DECIDE WHETHER I HAVE THAT LATITUDE OR NOT. I ACTUALLY DIDN'T THINK I DID. >> I DON'T KNOW. I WAS THINKING ABOUT IN THE CONTEXT OF DISCUSSION, IT SEEMS LIKE EVERYTHING WE'RE TALKING ABOUT IS A HIGHER RISK TRIAL AND WITH LIMITED RESOURCES AND WORRIED ABOUT PATIENTS COMPREHENSION AND IT SEEMS LIKE FOR SOME OF THE LOWER RISK TRIALS AND SIMPLER TRIALS THEY MAY NOT NEED THIS TRIAL AND MORE COMPLICATED AND HIGHER RISK THEY WOULD AND MAYBE IT WOULD MAKE THE DISCUSSION OF WHAT THESE ELEMENTS ARE A LITTLE BIT EASIER TO FOCUS IN ON WHAT THOSE 1S ARE THAT WERE PARTICULARLY CONCERNED ABOUT. >> I THINK ALSO BECAUSE YOU DON'T HAVE TO REPEAT, IF YOU CAN WRITE, GET ALL THE ELEMENTS OF CONSEBT IN YOUR KEY INFORMATION SECTION, YOU'RE DONE RIGHT? SO MAYBE IN RIGHTING THAT AND MAYBE THAT'S BETTER ANYWAY. JUDGE JUST FOR CLARITY SAKE, THE KEY ELEMENTS OF CONSENT THAT HAVE BEEN CONSENTED IN THIS MANNER IN THE REVISED REG THEY ARE NOT LIMITED TO APPLICATION TO CLINICAL TRIALS, THIS IS JUST THE CONTEXT IN OHRP ASKED THE COMMITTEE QUESTION SO I GUESS TO GET TO THAT ISSUE, I THINK THAT WHEN SACHRP OFFERS GUIDANCE ON THIS OR RECOMMENDATIONS THAT WHILE THE QUESTION IS LIMITED TO CLINICAL TRIALS, CLEARLY, GENERAL APPLICATION OF THE RULE WILL BE BROADER THAN THAT AND I GUESS DOES OHRP, IS THERE SOME PARTICULAR CONTEXT THAT YOU MIGHT WANT TO SHARE ON CLINICAL TRIALS FIRST AND I GUESS I WOULD SAY PART OF IT IS THAT THE BENEFIT FROM THIS CHANGE IS LIKELY TO BE MORE SIGNIFICANT IN TERMS OF THOSE TRIALS AND I COULD GIVE IT TO YOU IN WAYS I THINK ABOUT IT SO FOR EXAMPLE, SOCIAL AND BEHAVIORIAL STUDIES, IT'S PROBABLY--IF WE GET BACK TO WHY WERE WE MAKING THIS CHANGE? IT WAS BECAUSE OFTEN THERE'S DIFFICULT DECISION THAT THE PERSON HAS TO MAKE IN A COMPLICATED SCENARIO IN TERMS OF COMPLEXITIES OF CLINICAL CARE AND THEN IT COULD BE A CLINICAL SETTING, NOW WHEN YOU THEN ADDED THE ADD ON OR IN A RESEARCH SETTING IT'S MORE COMPLICATED. ON THE BEHAVIORIAL STUDY WHERE THERE'S NO QUESTION THAT YOU WILL NOT GET ANY BENEFIT FROM THE STUDY AND IT'S A QUESTION OF UNDERSTANDING THE TIME INVOLVED AND DISCOMFORTS TO YOU PARTICIPATING IN THIS STUDY, THAT PROANL IS NOT ALL THAT HARD TO EXPLAIN AND PROBABLY A LOT OF THE CURRENT CONSENT FORMS ARE GOOD AT DOING THIS AND IN FACT IF YOU HAVE THE CONSENT FORM SHORT ENOUGH, I THINK THIS IS DESCRIBED IN THE PREAMBLE TO THE FINAL RULE YOU WOULDN'T NEED A NEW CONSENT INFORMATION, IT'S SHORT ENOUGH YOU COULD COMPLY WITH THIS PROVISION WITHOUT ADDING ON ANYTHING. SO THAT'S PART OF THE SENSE THAT THIS NEW REQUIREMENT MAY NOT ACTUALLY BE DOING THAT MUCH IN TERMS OF ALTERING THE NATURE OF THE CONSENT FORMS FOR THESE OTHER TYPES OF STUDIES BUT WHEN YOU GET BACK TO THESE PARTICULARLY COMPLICATED CLINICAL TRIALS, MORE THAN MINIMAL RISK CLINICAL TRIALS, THAT'S WHERE IT MAY BE MAKING MOST OF THE CHANGES, AND GETTING BACK TO 1 OF THE POINTS PEOPLE WERE SAYING, THERE'S BEEN FAIR MENTION OF BEING A SUMMARY AND I WOULD GO BACK FROM--I DON'T KNOW THAT A LOT OF US THINK OF IT JUST AS A SUMMARY. IT IS NOT JUST TAKING AND EXTRACTING INFORMATION FROM OTHER PARTS OF THE CONSENT FORM BUT IT IS IMPORTANT, I THINK I SAID EARLIER FROM MY VIEW POINT. THE MOST IMPORTANT PART OF IT IS PUTTING IT ALTOGETHER AND EXPLAINING TO THE PERSON, YOU KNOW, IT'S NOOF THE JUST A RISK BENEFITS AND ALTERNATIVES BUT HOW DO YOU THINK ABOUT WHAT IS A COMPLICATED DECISION THAT YOU HAVE TO MAKE. SO AGAIN, THESE ARE SORT OF NEW ELEMENTS IN TERMS OF PARTICULARLY TRIALS WHERE THERE ARE COMPLICATED DECISIONS WHEREAS IN MANY OF THE 1S OTHER THAN PARTICULARLY HIGHER RISK CLINICAL TRIALS, THE DECISION ISN'T ALL THAT COMPLICATED TO MAKE AND IT'S PROBABLY NOT ALL THAT COMPLICATED TO SPELL OUT IN A CONSENT FORM AND THEREFORE, AGAIN, THIS NEW REQUIREMENT WILL PROBABLY BE LESS CONSEQUENTIAL AND IT'S PROBABLY NOT GOING TO BE AS HARD TO GIVE GUIDANCE IN TERMS OF WHAT YOU HAVE TO DO AND IN TERMS OF IMPLEMENTING THIS. SO, I THINK THAT'S PART OF THE SENSE OF IT THAT DOWN THE ROAD, THERE CERTAINLY WOULD BE GUIDANCE ABOUT IMPLEMENTING THOSE TYPES OF STUDIES, BUT IN SOME STUDIES YOU MAY NOT HAVE TO DO ANYTHING TO CONSENT FORM TO MEET THE NEW REQUIREMENT AND OTHERS THAT ARE PROBABLY MINIMAL CHANGES. >> I WOULD FOLLOW UP ON THAT BY SAYING, I WOULD WORRY FOR 2 REASONS ABOUT TRYING TO DRAW LINES ABOUT YOU KNOW DEMIN MEDICARE AND MEDICAID RISK, DO WE NOT HAVE TO THINK ABOUT THIS AT ALL. ONE IS--THE FIRST IS SORT OF PRAGMATICALLY ALL THE ARGUMENTS WE HAVE ABOUT WHAT COUNTS AS MINIMAL RISK. SO THAT YOU DON'T WANT DIFFERENT IRBs DRAWING DIFFERENT LINES ON WHERE KEY INFORMATION MATTERS AND DOESN'T MATTER. THE SECOND THING IS REALLY THAT I THINK THIS ECHOES SOME OF THE THINGS THAT JERRY SAID FIRST THING THIS MORNING THAT REALLY THE CONSENT FORM AND DISCUSSION ARE INTENDED TO SUPPORT AND PROMOTE AUTONOMOUS DECISION MAKING ON THE PART OF RESEARCH SUBJECTS. AND THAT IS TRUE REGARDLESS OF WHAT THE HARM BENEFIT BALANCE IS AND IT'S SOMETHING THAT WE SHOULD BE TRYING TO FIGURE OUT HOW TO PRO PROMOTE AND SOMETIMES THAT'S EASIER THAB OTHERS BUT IT'S ESSENTIAL FOR EVERY CONSENT FORM AND PROCESS. >> YOU KNOW JUST FOR THE PURPOSE OF DISCUSSION, I DID PUT UP THE REGULATORY LANGUAGE HERE AND IT SAYS EXCEPT FOR BROAD CONSENT, INFORMED CONSENT MUST BEGIN WITH A CONCISE AND FOCUSED PRESENTATION OF THE KEY INFORMATION. I DON'T SEE A LOT OF WIGGLE ROOM THERE. THE OTHER POINT THAT IF YOU'RE CONSENT FORM IS ALREADY CONCISE ENOUGH WHICH IS FAR MORE LIKELY TO BE TRUE IN SOME MINIMAL RISK STUDIES, PARTICULARLY NONCLINICAL TRIALS, IT DOES SOMEWHERE IN THE PREAMBLE POINT OUT THAT YOUR ENTIRE CONSENT FORM IS LIKE 4 PAGES LONG, WOULD KIND OF MEET THIS. >> ALL RIGHT. >> THAT WILL BE GOOD GUIDANCE TO HAVE. >> DAVID-- >> IT'S ON PAGE 66 OF THE PREAMBLE. I'M LOOKING AT IT RIGHT NOW. >> I WONDER, WE TOOK--THIS HAS ALL BEEN ABOUT KEY INFORMATION AND I THINK TAKING THAT PHRASE OUT OF CONTEXT MAY CAUSE US TO MISS AN OPPORTUNITY. SO, IT'S REALLY FOCUSED PRESENTATION OF THE KEY INFORMATION THAT IS MOST LIKELY TO ASSIST THE PERSPICTIVE SUBJECT OR LEGALLY AUTHORIZED REPRESENTATIVE SO IT'S NOT JUST WHICH INFORMATION SHOULD BE IN THIS AND THAT IT NEEDS TO BE READABLE. IT'S HOW YOU PRESENT IT SEQUENTIALLY AND STRUCTURALLY TO WALK PEOPLE THROUGH A DECISION WHICH I DON'T THINK THAT WE DISCUSS EXPLICITLY, WE'VE REALLY TALKED ABOUT WHAT IS THE KEY INFORMATION. WE HAVEN'T TALKED ABOUT HOW YOU STRUCTURE THAT KEY INFORMATION TO FACILITATE DECISION MAKING AND THAT MAY BE GETTING TO SOME OF THE EARLIER DECISIONS, THAT MAY--THAT DISCUSSION, THAT MAY BE THE MORE IMPORTANT PIECE. AND WE DID TALK ABOUT THE PRO-COLUMN AND WHY YOU WANT TO DO THIS AND WHY YOU WOULDN'T WANT TO, BUT WHEN WE TAKE IT BACK TO SUBCOMMITTEE WHICH IT'S TOO BIG TO DO NOW, THINK ABOUT LITERATURE AND DECISION MAKING AND HOW TO ACTUALLY BEST WALK PEOPLE THROUGH THIS AS A SECISION, NOT AGAIN--DECISION. NOT AGAIN GOING BACK TO THE OLD STYLE AND LISTING INFORMATION BUT MAKING IT MORE ACCESS EBL AS FACT EMPLOY BUT PRESENTING IT IN A DIFFERENT WAY. >> THAT'S CERTAINLY THE PART THAT WOULD BE RELEVANT TO ALL OF THESE TYPES OF TRIALS THAT--RIGHT, THE BOTTOM LINE IS THE CHANGE IS ABOUT MAKING IT MORE UNDERSTANDABLE TO SOMEBODY, LOOK AT THE HEART OF IT, THIS IS WHAT PARTICIPATION IN THIS TRIAL IS ABOUT AND HERE'S THE WAY MOST PEOPLE WOULD--WHAT MOST PEOPLE WOULD WORRY ABOUT IN TERMS OF DECIDING WHETHER THEY WANT TO BE IN THE TRIAL OR TO STUDY, WHATEVER IT IS. OR NOT. >> ABSOLUTELY. >> LESLIE DO HAVE YOU A FEDERAL REGISTER PAGE IN FRONT OF YOU. >> THANKS. >> SORRY, EXCUSE ME, I'M MICAH BASS, CDC EXOFFICIO THERE, YOU ASKED THE QUESTION ABOUT WHAT WOULD BE HELPFUL TO US AND ANOTHER ASPECT WHEN WE'RE LOOKING AT THIS, YOU ALL HAVE PUT A TREMENDOUS AMOUNT OF WORK BUT THE DIFFICULT THING FOR US HAS BEEN DISENTANGLING OF THE REASONABLE PERSON STANDARD APART FROM WHAT WOULD BE KEY INFORMATION PRESENTED IN A CLEAR FOCUS AND CONCISE MANNER AND SO, IN CONTEMPLATING AND OPINING ON THIS, IT'S BEEN DIFFICULT TO SEPARATE THEM OUT. AND SO WHAT WOULD BE VERY HELPFUL AND EVEN POSSIBLY RETHINKING IT A BIT IS MORE THE PROCESS, AND SOME OF THE KEY CONSIDERATIONS, WHEN YOU ARE APPROACHING THIS, ESPECIALLY FOR THE REASONABLE PERSON STANDARD IN MIND AND TRYING TO GET TO WHAT IS KEY INFORMATION AND HOW IT'S PRESENTED. SO, IT'S--IT'S CONCEPTUALLY OR MAYBE TRUSTEES A PRACTICAL STANDPOINT A BIT DIFFICULT TO APPROACH THEM FROM--IN A COMPARTMENTALIZED WAY. >> THANK YOU. OTHER COMMENTS? DAVID IS THERE ANYTHING--I WILL WAIT FOR YOU TO FINISH. >> THANK YOU. LET ME KNOW IF I GOT THAT. SO IS THERE ANYTHING ELSE WE EXPLICITLY LEFT HANGING TO COME BACK TO THIS AFTERNOON? >> NO. >> WE DIDN'T TALK AT ALL, ALTHOUGH I THINK IT WAS BEHIND A LOT OF THE CONVERSATION ABOUT THERAPEUTIC MISCONCEPTIONS, AND I KNOW WE TALKED AT THE SUBCOMMITTEE ABOUT WHETHER WE SHOULD SORT OF CONFRONT THAT HEAD ON. >> YEAH I'LL KIND OF REPEAT THE DEBATE OR THE DISCUSSION, IT WAS NOT A DEBATE ONE OF THE THINGS THAT CAME UP IN A COUPLE DIFFERENT CONTEXT IN THE SUBCOMMITTEE DISCUSSION SYSTEM WHETHER THIS REQUIREMENT FOR KEY INFORMATION WILL CHANGE THE WAY WE VIEW THE ROLE OF THERAPEUTIC MISCONCEPTION AND CONSENT FORMS. WHAT I MEAN IS THERE'S BEEN A TRADITION SINCE THERAPEUTIC MISCONCEPTION CAME OUT TO DOWN PLAY BENEFIT IN THE FORM SO SUBJECTS ARE LESS LIKELY TO SUFFER FROM THERAPEUTIC MISCONCEPTION AND I THINK IT COULD TAKE A COUPLE DIFFERENT FLAVORS OR ASPECTS. ONE IS TO JUST NOT SAY MUCH ABOUT BENEFIT. MAKE THE STATEMENT GENERAL. YOU MAY BENEFIT FROM PARTICIPATION IN THIS STUDY, OR YOU MAY NOT. SO WE DON'T GET PEOPLE THINK THANKSGIVING IS GOING TO HELP CURE THEIR CANCER. WE WANT TO HELP DISTINGUISH RESEARCH FROM CLINICAL CARE. AND I REMEMBER A PRESENTATION, BY AN IRB CHAIR WHOSE WIFE WAS GOING THROUGH CANCER AND YOU SAID YOU KNOW WHAT I'VE BEEN DOING ALL THESE YEARS, WE'VE BEEN EXTINGUISHING HOPE IN THE CONSENT BECAUSE WE'RE SO WORRY BODY THEOR PUTTIC MISCONCEPTION THAT WEARY DESTROYING HOPE. AND IT STRUCK ME AT THE TIME HE SAID IT SO WHAT WE WERE DISCUSSING AT THE SUBCOMMITTEE LEVEL IS WHETHER THIS IS GOING TO MAYBE MOVE OIRKS RBs AWAY FROM THAT AND MORE TOWARDS THE BENEFIT FOR YOU AND THE REASON YOU MAY WANT TO JOIN THIS STUDY IS THAT IT LOOKS LIKE A DRUG THAT AS A REASONABLE CHANCE OF CURING YOUR CANCER AS OPPOSE TO YOU MAY BENEFIT. SPRKS SO THE FLIP SIDE OF THAT IS TO SAY IN A PHASE 1 TRIAL, EXPERIENCES SUGGEST THERE'S LESS THAN 1% CHANCE FOR YOU TO BENEFIT AND I THINK IT GOES TO DIANEA'S CONCEPT ABOUT ALTRUISM. THE REALITY IS PARTICULARLY IN CANCER TRIALS BUT PROBABLY IN MANY, MANY RPGHTS AS WELL THAT THE REALITY IS THAT MANY PEOPLE ARE PARTICIPATING OUT OF THE HOPE REALISTIC OR NOT, THAT THEY WILL HAVE INDIVIDUAL BENEFIT AND WE TRY TO IGNORE THAT WHICH IS CONFUSING. IT CERTAINLY DON'T HELP DECISION MAKING. >> WELL YEAH, IGNORING IT IS THE WORST THING 1 CAN DO IN TERPS OF INFORMING PATIENT SUBJEBLGHTS OF WHAT'S GOING ON. I THINK ACTUALLY, AND HOW MUCH OF THIS GOES IN KEY INFORMATION AND HOW MUCH OF IT IS JANE'S MODELY OF WE SAY A LITTLE BIT AND DO A CROSS REFERENCE, REMAINS TO BE SORTED OUT ON A TRIAL BY TRIAL BASIS BUT THE MORE SPECIFIC 1 CAN BE THE--YOU DON'T--YOU DON'T SQUELCH HOPE. YOU ENCOURAGE PROBLEMATIC HOPE WITH VAGUE LANGUAGE BUT IF YOU SAY, YOU KNOW THERE'S--THE REASON THAT WE'RE STUDYING THIS INTERVENTION IS BECAUSE WE'VE SEEN SOME LIKELIHOOD THAT IT COULD SHRINK TUMORS AT LEAST TEMPORARILY, THAT'S A VERY DIFFERENT STATEMENT FROM IT MIGHT ACTUALLY CURE OR YOU MIGHT LIVE LONGER AND SO YOU BASE THE INFORMATION ON THE EVIDENCE THAT YOU HAVE AND ALLOW PEOPLE TO HOPE AS LONG AS THEY KNOW WHAT'S REALISTIC TO EXPECT. SO I WOULD CAM PLETELY AGREE WITH THAT BUT I HAVE TO ACKNOWLEDGE DAVID'S POINT THAT THAT'S NOT HOW IRBs CURRENTLY THINK AND I THINK WE'VE BEEN TRAINED THROUGH THE BIOETHICS KEVERGDZ TO REALLY--CONVERSATION TO REALLY BE SCARED OF THERAPEUTIC MISCONCEPTION AND SEE IT AS PRETTY MUCH BAD. MISCONCEPTION. >> YEAH, I THINK THERE'S ALSO BEEN A TREND THOUGH, YOU KNOW THERE WAS A PRETTY STRONG IDEA, YOU KNOW WITH CLINICAL EQUIPOISE AND KIND OF AN EARLIER VERSION OF THE DECLARATION OF HELSINKI OF THERAPEUT AND I CAN NONTHERAPEUTIC AND THERE'S JUST THIS BLACK LINE DOWN THE MIDDLE. AND WE'VE BEEN MOVING TOWARDS RESEARCH THAT IT HAS DIRECT BENEFIT TO AN INDIVIDUAL SUBJECT AND CERTAINLY WHEN YOU GET TO THE LEARNING EN--STRATEGIES TUITION MODEL AND SOME OF THE THINGS THAT WE'RE--JOHNS HOPKINS BIOETHICISTS HAVE BEEN PROPOSING THERE ARE MUCH MORE PUTTING CLINICAL CARE AND RESEARCH TOGETHER IN MORE OF A SINGLE BUCKET. SO PERHAPS THIS IS PART OF THAT SAME TREND. >> THE TRIAL THAT WE WERE TO READ FOR THIS MEETING YOU KNOW I POINTED OUT TO YOU THAT BENEFIT SECTION SAYS, YOU KNOW THIS RESEARCH STUDY, YOU KNOW YOU MAY NOT RESPOND TO THESE THESE DRUGS THAT ARE STANDARD OF CARE DRUGS KNOWN AND APPROVED FOR TREATMENT AND IN THAT STUDY POPULATION AND THE FACT IS EVEN IN A CLINICAL SITUATION, YOU MAY NOT RESPOND. YOU ARE GOING TO RESPOND. BUT THERE YOU HAVE A LOT OF ECHEDZ IN THE WAY OF APPROVED DRUGS FOR THAT CONDITION, WHY WOULD YOU STATE IT THERE? >> I AGREE. I GUESS 1 RELATED POINT IS--AND I AM TRYING TO THINK OF CONTEXT BUT I HAVE CERTAINLY HEARD THIS, THAT IF, YOU KNOW, YOU DESCRIBE ALL OF THE RISKS AND NUMBERS, PERHAPS PARTICULARLY WITHOUT THE BENEFITS, WHY WOULD ANYONE PARTICIPATE? WHICH OF COURSE IS A REALLY AWFUL REASON NOT TO DESCRIBE THE RISKS. IF PEOPLE DIDN'T PARTICIPATE KNOWINGLY THEN THEY SHOULDN'T BE ASKED TO PARTICIPATE. BUT I GUESS THAT'S THE OTHER THING THAT WE REALLY--WHEN THE WHOLE IDEA OF THERAPEUTIC MISCONCEPTION MADE SURE THAT IF WE ERRED IT WAS ERRINGOT CONSERVATIVE SIDE. IF WE RECAST THIS WITH ACKNOWLEDGMENT OF HOPE AND THERAPEUTIC POSSIBILITY AND STUFF, WE WILL HAVE TO BE CAREFUL THAT YOU KNOW IT DOES OPEN--I THINK THAT WAS WRONG BUT PROVIDED 1 STRATEGY TO SORT OF AVOID THE POSSIBILITY OF MARKETING TRIALS WHICH WILL HAVE TO BE MORE VIGILANT FOR WHEN YOU'RE ACTUALLY PRESENTING INFORMATION TO FACILITATE DECISIONS THERE'S A WHOLE INDUSTRY ABOUT YEAH, YOU FACILITATE DECISIONS CERTAIN WAYS BUT WE WILL HAVE TO ARE VIGILANT. IT DOES NOT CREEP INTO OUR CONSENT FORMS. >> YOU PICK UP. THIS IS AN IMPORTANT POINT ON PICKING UP NANCY'S POINT RELATING JUST TO GIVE YOU ANN ECTOMYOSIN DETOMORROW NATION. BECAUSE I THINK IF YOU ARE GIVING ACCURATE INFORMATION, THAT'S A GOOD THING AND THE FACT THAT YOU'RE GIVING ACCURATE INFORMATION PARTICULARLY ABOUT BENEFITS, THAT'S FINE BECAUSE IN 1 INSTANCE, THIS IS A REAL STUDY AND OHRP WAS INVOEVERLED IN A COMPLIANCE RELATED ISSUE AND REVIEWING CONSENT FORM AND THE CONSENT FORM SAID, THERE'S NO POSSIBILITY OF BENEFIT. THAT WAS THE BENEFIT SECTION AND THE RISK SECTION, ACTUALLY CORRECTLY DETAILED THE SUBSTANTIAL RISKS INVOLVED IN TERMS OF THE INTERVENTION SO YOU PUT IT ALL TOGETHER, IT'S LIKE THE CONSENT FORM SORT OF GETTING BACK TO WHAT THE KEY CONCISE INFORMATION SECTION SHOULD TELL YOU IF ALL OF THAT WAS TRUE, IT SHOULD BE SAYING, YOU KNOW, YOU BETTER WANT TO BE REALLY ALTRUISTIC TO BE IN THIS TRIAL. IT COULD BE THE IMPORTANT QUESTION BEING ANSWERED BUT THERE WERE LIKE POSSIBLY LIFE THREATENING RISKS THAT MIGHT COME TO YOU FROM BEING IN A TRIAL AND OUR POINT WAS THAT ACTUALLY THERE WERE SUBSTANTIAL POSSIBILITIES OF BENEFIT AND THE PEOPLE WHO WROTE THE CONSENT FORM ACKNOWLEDGEDDED, WELL THEY DIDN'T WANT TO SAY THAT BECAUSE THEY WERE WORRY BODY PROMISAING A BENEFIT THAT DIDN'T EXIST. BUT IF YOU GO THE DIRECTION OF DENYING THESE BENEFITS THESE BECOME INCOHERENT. SO YES, BEING ACCURATE ABOUT THE POSSIBILITY OF THE BENEFIT AND PROVIDING USEFUL NONGENERAL INFORMATION ABOUT THE LIKELIHOOD AND THE TYPE OF BENEFIT IS A GOOD THING IN TERPS OF ALLOWING PEOPLE TO MAKE MEANINGFUL DECISIONS. IN FACT IF YOU DIDN'T PROVIDE THAT INFORMATION, PEOPLE MAY NOT ENROLL IN THE TRIAL PRECISELY BECAUSE YOU HAVE MISINFORMED THEM. THAT IS NOT A GOOD THING. SO THIS CERTAINLY IS A CHALLENGE IN TERMS OF NOT PROMOTING A THERAPEUTIC MISCONCEPTION BUT GIVING ACCURATE INFORMATION SO THAT PEOPLE CAN DECIDE TO BE IN TRIALS, WHEN THEY WOULD GENUINELY WANT TO BE WHERE THEY WERE APPROPRIATELY MISINFORMED IS PERFECTLY APPROPRIATE. >> AND ACTUALLY--I THINK FIGURING OUT HOW TO DESCRIBE WHAT APPROPRIATELY COUNTS AS A POTENTIAL FOR DIRECT PEN FIT IN ACCESSIBLE LANGUAGE AND ACTUALLY A VERY IMPORTANT CHALLENGE, YOU KNOW BECAUSE TUMOR SHRINKAGE MAY OR MAY NOT BE SOMETHING THAT'S PERCEPTIBLE TO A PATIENT'S SUBJECT. MIGHT BE SOMETHING THAT DIFFERENT CHANGE QUALITY OR LENGTH OF LIFE SO HOW DO YOU DESCRIBE, YES THIS COULD HAPPEN BUT WE DON'T KNOW WHAT KIND OF EFFECT IT WILL HAVE ON THE LENGTH OR QUALITY OF LIFE. THAT'S THE REASON WHY IN THE EARLIER PRESENTATION, I SORT OF PICKED UP ON THAT DOCETAXOL COULD KILL YOUR CANCER BECAUSE LEAVING OUT KILL YOUR CANCER CELLS SEEMS TO ME LIKE POTENTIALLY MISINTERPRETED AS AN OVERSTATEMENT SAYING DOCETAXOL COULD ACTUALLY CURE YOU WHERE KILL YOUR CANCER CELLS IS MAYBE NOT THE RIGHT WAY TO SAY IT BUT IT'S A BIT LESS SWEEPING OF A STATEMENT. SO HOW YOU ACTUALLY CONVEY DIRECT BENEFIT, IRBs AND INVESTIGATORS AND WRITING CONSENT FORMS HAVE SORT OF GOT OFF EASY BY SAYING YOU MAY OR MAY NOT BENEFIT BECAUSE THEY HAVEN'T FACED THE DIFFICULTIES OF HOW TO CONVEY WHAT WE KNOW IN A CLEAR CONCISE AND COMPREHENSIBLE WAY SO THAT'S A CHALLENGE THAT WE CAN WAVE AT IN KEY INFORMATION DISCUSSION AND MAYBE NOT ADDRESS THOROUGHLY BECAUSE IT'S REALLY FOR THE REST OF THE CONSENT FORM TO FINISH THE JOB. >> SO, I JUST WANT TO ACKNOWLEDGE AND IT'S NOT RIGHT OR WRONG BUT WE ARE PUTTING OUR TOE IN THE WATER OR CRACKING THE DOOR OR SOMETHING ABOUT BENEFITS. WHERE WE ACTUALLY KNOW THERE ARE REASONS PEOPLE ENROLL IN TRIALS, THAT DON'T ACTUALLY HAVE ANYTHING TO DO WITH THE RESEARCH IT MAY HAVE TO DO WITH COST, MAY HAVE TO ON WITH PAYMENT AND DO WITH OUR INCREASINGLY DIFFICULT TO ACCESS HEALTHCARE SYSTEM, THEY MAY HAVE TO DO WITH ACCESS TO CARE. AND THOSE ARE AREAS THAT WE'VE TRADITIONALLY NOT MADE EXPLICIT IN THE CONSENT FORMS IF WE'RE GOING TO BE HONEST IN A LIST OF& WHY YOU WANT--THEY WANT TO ENROLL IN THIS TRIAL, I THINK WE'RE GOING--I DON'T KNOW THE ANSWER. BUT I THINK WE MAY BE FACED WITH GRAPPLING WITH THOSE REALITIES. >> STEPHEN IF I COULD BRING UP 1 MORE OOS SPECT OF THAT, FDA SAYS DON'T CALL PAYMENT A BENEFIT. IT IS NOT A BENEFIT. PUT IT ELSEWHERE, MAYBE IT'S A BENEFIT AND PEOPLE GO THAT'S WHY I'M JOINING THE STUDY, I'M GETTING PAID. I THINK MONEY IS A GREAT THING AND I LOVE GETTING IT. >> [LAUGHTER] >> PHASE 1. >> WELL IT'S NOT A DIRECT BENEFIT BECAUSE IT'S SOMETHING THAT EVERYBODY GETS THE BENEFIT OF BEING IN THE TRIAL, MAKES IT AN INCLUSION BENEFIT, RATHER THAN A CONSEQUENCE OF GETTING INTERVENTION INTERVENGDZ BUT IF YOU ASK ME WHAT MAY CAUSE ME TO WANT TO ENROLL IN THIS TRIAL, AND YOU'RE A PHASE 1 HEALTHY VOLUNTEER, FACING A IN-PATIENT STAY IN A WEEK WHILE YOU GET EXPERIMENTAL MEDICINE THAT, IS THE REASON. >> WELL, YEAH, BUT I THINK--I THINK I'M NOT SAYING WE SHOULDN'T TALK ABOUT IT BUT I'M SAYING THAT WE SHOULD BE CAREFUL HOW WE DESCRIBE IT. AND THERE'S SOMETHING ELSE HERE, TOO THAT I THINK NEEDS TO BE PART OF THE INITIAL FRAMING THAT I THINK ADDRESSES ALL OF THESE PRO AND CONREASONS BECAUSE WE SHOULDN'T ASSUME THAT EVERY PATIENT SUBJECT ENROLLS FOR THEIR OWN REASONS AND USING THE WORD ALTRUISM IS KIND OF HIGH FL ATINAND ALL THAT. YOU ARE BEING ASKED TO PARTIC 8 IN THIS TRIAL BECAUSE YOUR EXPERIENCE AND WHAT WE LEARN FROM YOU IS GOING TO CONTRIBUTE TO OUR INCREASING KNOWLEDGE OF YOUR DISEASE AND THESE INTERVENTIONS AND YOU FRAME IT THAT WAY SO YOU'RE NOT SAYING WE WANT YOU TO BE AN ALTRUIST, AND YOU'RE NOT SAYING GENERALIZABLE KNOWLEDGE BUT YOU'RE SAYING THE REASON WE'RE ASKING YOU IS BECAUSE WE WANT TO LEARN FROM WHAT YOU CAN CONTRIBUTE AND THEN IN ADDITION THERE'S THIS POTENTIAL FOR BENEFIT AND SO FORTH. AND THAT'S REALLY AN ESSENTIAL PART OF THE FRAMING THAT IS THE CASE FOR EVERY ENROLLMENT IN EVERY CLINICAL TRIAL. THAT THERE'S A PURPOSE THAT IS--THAT IS DIFFERENT FROM THE PURPOSE OF JUST CLINICAL INTERVENTIONS. EVEN IF WE CAN'T SAY FOR SURE THAT THERE ARE THESE BIG DIFFERENCES BETWEEN RESEARCH AND TREATMENT, THERE IS THAT. AND THAT DOESN'T GET SAID CLEARLY ENOUGH IN A LOT OF CONSENT FORMS. SO I THINK IT SHOULD BE PART OF OUR FRAMING. >> YOU KNOW IT'S THE ONLY WAY TO GET ACCESS TO A 2 HELPED THOUSAND DOLLARS AMINO THERAPEUTIC DRUG. YOU ENTER FOR THAT REASON, ARE YOU TALKING ABOUT PROFESSIONAL PATIENTS? >> WELL, SO I WOULD JUST NOTE THAT THE REGULATIONS ARE NOT SPECIFIC TO ANY PARTICULAR PATIENT GROUP OTHER THAN EXCLUDING THOSE GETTING BROAD CONSENT. SO WHATEVR WE DO, PARTICULARLY IF WE'RE TALKING ABOUT CLINICAL TRIALS WHICH INCLUDES THAT GROUP, I THINK--SO, THAT GROUP KNOWS EXACTLY WHAT THEY'RE GETTING. SO I DON'T THINK WE HAVE TO HELP THEM WITH THEIR DECISION MAKING. SO I DIDN'T MEAN--I TOOK THAT AS AN EXTREME, BUT JUST TO ONCE WE OPEN THE IDEA OF BENEFITS TO THINGS OF GUIDANCE AND TRADITION AS TAKEN OFF THE TABLE BUT REALLY ARE RELEVANT TO PEOPLE MAKING DECISIONS WHETHER TO ENROLL IN THE TRIAL, I JUST THINK WE HAVE TO DO THAT WITH OUR EYES OPEN. >> I COMPLETELY AGREE. THE WHOLE FOCUS OF THIS NEW REQUIREMENT IS TO HELP PATIENTS AND OTHER TYPES OF POTENTIAL PARTICIPANTS DECIDE WHETHER OR NOT TO PARTICIPATE. SO THE MORE THAT WE'RE TALKING ABOUT THIS, I THINK FRANKLY IRRELEVANT TO TALK ABOUT RISKS AND BENEFITS. I AM MUCH MORE ATTRACTED TO THIS FRAMING OF WHY SHOULD I WANT TO PARTICIPATE? WHY SHOULD I NOT WANT TO PARTICIPATE IN AND THERE ARE ALL SORTS OF THINGS THAT CAN FALL INTO EACH OF THOSE BUCKETS. THE COST OF MY PARKING PERMIT WILL BE TOO MUCH OR I'M GOING TO HAVE TO GET A BABYSITTER 20 TIMES. TO A PATIENT, THOSE MIGHT BE ON THE SAME LEVEL WITH PHYSICAL RISK THAT THEY MIGHT BE EXPOSED TO BECAUSE PEOPLE LIVE WHOLE LIVES, AND I DON'T THINK WE SHOULD TRY TO SEGMENT PARTICULAR RISKS THAT COME FROM THESE STUDY INTERVENTION THAT VERSUS THAT COME FROM THE BURDEN OF GOING TO THE CLINIC A BUNCH OF TIMES, VERSUS SPENDING YOUR TIME THIS WAY, WHEN YOU COULD BE DOING OTHER THINGS WITH YOUR TIME. I--I REALLY ENCOURAGE US TO GET OVER KIND OF THE TRADITION OF RISKS AND BENEFITS EVEN THOUGH THAT'S WHAT'S IN THE OTHER REGULATORY LANGUAGE AND JUST THINK ABOUT HOW PATIENTS ARE ACTUALLY MAKING THESE DECISIONS, THE SAME WAY THEY MAKE ALL OTHER LIFE DECISIONS. WE HAVE TALKED ABOUT PRO-CON LIST, THAT IS PROBABLY THE MORE ENLIGHTENED WAY OF THINKING ABOUT IT. >> I KNOW I HAD A THOUGHT I'M ALMOST SCARED TO TALK ABOUT. YOU KNOW THINKING OF THE OLD FDA INFORMATION SHEETS AND THE YOU KNOW THE NEW GUIDANCE ON INFORMED CONSENT. I SUPPOSE AT SOME POINT WE SHOULD GO LOOK AT THOSE WITH AN EYE ON KEY INFORMATION AND SAY, IS THERE ANYTHING IN THERE THAT WILL PROHIBIT PEOPLE FROM PEOPLING COMFORTABLE PUTTING INFORMATION AS KEY INFORMATION. OTHERWISE, MIGHT EFFECT THEIR JUDGMENT? I HADN'T THOUGHT OF THAT. >> QUESTIONS, THAT I WAS THINKING OF, THAT WOULD BE HELPFUL IN TERMS OF FRAMING IS WHEN WE THINK ABOUT THE PURPOSE OF WHY THIS STUDY IS BEING DONE AND WHY AND HOW WE WOULD EXPLAIN THAT TO PEOPLE, WE MIGHT JUST TRY TO SAY, WHAT DID WE KNOW AND WHAT DON'T WE KNOW ABOUT THIS INTERVENTION? SO WE SAY THINGS LIKE WHY ARE WE DOING THIS STUDY? AND THEN WHY TALK ABOUT END POINTS OR OBJECTIVES, BUT IF WE TRY TO SHIFT THE FRAMING TO FOCUS ON UNCERTAINTY, THAT MIGHT HELP WITH REGARD TO THE THERAPEUTIC MISCONCEPTION AND OTHER FEATURES. >> SO I THINK THIS IS RIGHT AND TRUE TO THE SPIRIT OF THE REGULATIONS. I CONTINUE--I HAVE SOME DISQUIET BECAUSE I THINK THAT IN A WAY THE OLD CONSENT FORM WAS OPAQUE AND IN MANY WAYS A REFERENCE DOCUMENT THAT DIDN'T HELP IN THE DECISION MAKING SO WE HAD THE CONSENT PROCESS AND WHO KNOWS WHAT WENT ON IN THAT SETTING. NOW IF WE SPECIFICALLY EMBRACE THE DECISION MAKING WITH ALL THAT IMPLIES IN THE--UP FRONT IN THE CONSENT FORM, IT REALLY DOES, AGAIN AND IRBs COULD ALWAYS DEAL WITH THE OLD FORMS BECAUSE THEY LOOK AT THE FORMS, THEY LOOK AT THE READING LEVELS. BECAUSE IT WAS FORWARD. IT DOES CONCERN ME BECAUSE 1 OF THESE FORMS WILL BE USED TO MARKET STUDIES AND I THINK HAVING SORT OF A SOFTER MORE DECISION MAKING SUPPORTING KIND OF THING IS WE WILL HAVE TO LEARN HOW TO AVOID THAT BECAUSE IT'S MUCH EASIER THROUGH CHOICE OF WORDS AND PRESENTATION TO EFFECT DECISION MAKING THAN IT IS WHEN YOU'RE SAYING WE WON'T SAY ANYTHING ABOUT BENEFIT, IT WILL ALL BE RISK. SO I THINK THAT'S JUST THE REALITY OF THINGS. >> BUT I DON'T THINK THE 2 APPROACHES ARE MUTUALLY EXCLUSIVE. PICKING UP ON JOIN'S POINTS, THE--JANE'S POINTS, THE FIRST TBO PAGES OR WHATEVER COULD BE COUCHED IN TERMS THAT HOLLY'S THINKING AND THEN IN THE SUPPLEMENTARY MATERIAL, WE COULD BE MUCH MORE TYPICAL AS WE ARE TODAY. >> ANY LAST COMMENTS OR QUESTIONS? WELL, THANK YOU ALL. THIS HAS BEEN REALLY WONDERFUL DISCUSSION. AND IT'S 1 OF THE REASONS I HAVE SO MUCH ENJOYED THESE MEETINGS. SO WE'RE ABOUT HALF AN HOUR AHEAD OF SCHEDULE. I THINK PUBLIC COMMENT IS SCHEDULED FOR 3:30. SO WHY DON'T WE TAKE A 15 MINUTE BREAK TO 3:15 AND COME BACK FOR PUBLIC COMMENT. IT WILL BE EARLY BUT IF ANYONE WAS PLANNING TO COME, IT WON'T BE SO EARLY THAT THEY SHOULDN'T BE HERE. THANK YOU. I WILL TRY TO PUT OUT MORE INSTRUCTIONS ON HOW TO USE THAT. SO I WOULD INVITE ANYONE WHO WANTS TO TAKE THE TIME AFTER I SEBD OUT MORE EXPLICIT INSTRUCTIONS TO TRY TO DO THAT BECAUSE I THINK IT WOULD BE INTERESTING. AND IF YOU DO USE--IF YOU DO WANT TO TRY THAT ISSUES DON'T ASSUME THAT I GOT IT RIGHT AS FAR AS THE BREAK DOWN OF THE STUDIES. THAT'S WHAT I CAME UP WITH OFF THE TOP OF MY HEAD. I CAN TELL YOU 1 THING TAKEN--THEY WAS CONFUSING ME WHEN I WAS DOING IT WAS THE DIFFERENCES BETWEEN THE AREAS OF INTEREST THE AREAS OF INFORMATION THAT WOULD SATISFY THOSE INTERESTS, SO YOU MAY HAVE AN INTEREST IN--SO PHASE 1 HEALTHY VOLUNTEER STUDIES, 1 OF YOUR INTERESTS IS PAYMENT. WHAT SATISFIES THAT INTEREST IS PAYMENT. SO, THERE'S SOME SORT OF POETIC POTENTIAL CONFUSION BETWEEN THE PROS, AND CONS AND THOSE ROWS, BUT THEY'RE ALSO OPEN TO COMMENT OR DEBATE. IF YOU CHOOSE TO ADD YOUR OWN OR TAKE SOME OFF. DO IT ANYWAY. I THINK THE RESULTS ARE INTERESTING, YOU KNOW WHEN THINGS GET GROUPED TOGETHER. LESLIE? >> WHEN I WAS LOOKING AT PERCEIVED BENEFIT, I DIDN'T SEE RETURN OF RESULTS AS A PERCEIVED BENEFIT, I SAW IT ON I DIFFERENT AND PARTICULARLY, I HAVE A STUDENT IN MY HUMAN SUBJECTS CLASS NOW, WHO VERY MUCH THAT'S 1 OF THE THINGS SHE'S MOST INTERESTED IN IS GETTING ACCESS TO THE INFORMATION AND SO SHE IS REALLY ELEVATED THAT ISSUE THIS SEMESTER. >> [INDISCERNIBLE]. >> YEAH, BUT THAT'S NOT THE WAY I HEAR HER TALKING ABOUT IT. THAT'S--THAT IN AND OF ITSELF THAT THERE ARE THOSE WHO ARE SORT OF JUST INFORMATION SEEKERS AND YOU KNOW, I'M NOT GOING TO DO 23 AND ME, BUT YOU KNOW, THERE ARE MANY WHO WILL AND THEIR INFORMATION SEEKERS. >> [INDISCERNIBLE]. >> I KNOW FOR SURE THAT JONATHAN AND I ARE INTERESTED IN WORKING MORE ON THE FRAMING PIECE TAKEN--THEY WE'VE BEEN TALKING ABOUT AND I DON'T KNOW IF THIS IS KOSHER OR NOT BUT I THINK THERE ARE PROBABLY--HOLLY'S PROBABLY INTERESTED ALSO BUT THERE'S PROBABLY PEOPLE LIKE DIANEA AND LESLIE WHO ARE NOT ON THE SUBCOMMITTEES WHO MIGHT ALSO WANT TO HELP WITH CRAFTING PIECES OF THE DOCUMENT IN PLACES WE DISCUSSED AND IS THAT OKAY FOR--SO HOW WOULD THAT WORK, DAVID? WOULD YOU SEND OUT A NEW DRAFT TO EVERYBODY AND LET US TAKE A CRACK AT IT? OR ... >> [INDISCERNIBLE]. >> GREAT. >> SO I'M NOT SURE IF IT'S SOMETHING WE WANT TO TAKE ON BUT I WAS TALKING TO DIANA, BUT PUTTING TOGETHER WHAT JANE SAID AND TRYING TO THINK ABOUT IT IN MY OWN HEAD AND IT CAME UP AND I ASKED DIANA SPECIFICALLY ABOUT THAT. WHEN YOU PRESSED HER ON IT, IT WAS THE QUESTION ABOUT BIOSPECIMEN COLLECTION AND WHETHER THAT SORT OF ELEVATES UP TO KEY INFORMATION IN THE CONTEXT OF A TRIAL AND TRYING TO THINK THAT THROUGH AND WHETHER IT MIGHT BE HELPFUL TO THINK ABOUT EXAMPLES, LIKE TANGIBLE EXAMPLES AND I SORT OF, WORKED IT THROUGH A LITTLE BIT WITH HER THAT IF IT WERE A BIOPSY SAMPLE AND PARTICULARLY REPEATED BIOPSY IN THE CONTEXT OF A TRIAL, BUT THAT PROBABLY WOULD BECAUSE INVASIVE AND ALL OF THAT WHEREAS IF IT WERE SIMPLY BLOOD SAMPLE OR OTHER SAMPLE FOR SEQUENCING MORE GENERALLY THAT IT MAY NOT IN THE CONTEXT OF A TRIAL BUT IN SAY, ALL OF ME, OR OTHERS WHERE THAT IS THE PRIMARY BOTH PROCEDURE AND RISK, YOU KNOW SO IT MAY BE HELPFUL TO SORT OF WALK THROUGH NOT AS THE EXCLUSIVE EXAMPLES BUT SOME OF THOSE PIECES THAT MIGHT HELP IN THINKING ABOUT HOW DOES 1 THINK THROUGH? DOES IT ELEVATE UP TO KEY INFORMATION OR IS THIS THE KIND OF INFORMATION THAT GETS REFERRED TO IN THE BODY OF THE DOCUMENT. >> SO WE DIDN'T TALK ABOUT JANE'S WHOLE--SHE WAS THE WHOLE 12 ARTICULATED THAT CLEARLY ALTHOUGH THE ABILITY TO LINK AND INDEX I THINK HAS BEEN THERE BUT THE IDEA OF ACTUALLY LEAVING THE DETAILS OUT AND LINKING TO THE PROTOCOL. THERE ARE SIGNIFICANT RISKS, SEE PAGE--WHAT DO WE THINK ABOUT THAT? WE DIDN'T TALK ABOUT OR DIDN'T REALLY HAVE A CHANCE--CONSENT? I'M SORRY. YEAH, I MEANT CONSENT. >> [INDISCERNIBLE]. . >> I THINK THE BALANCE BETWEEN REALLY GENERAL AND A LINK TO THE REST OF THE CONCEPT FORM AND SOME INFORMATION AND A LINK TO THE REST OF THE CONSENT FORM WILL BE TRICKY AND THAT'S SOMETHING THAT I THINK WE'RE GOING TO DISCOVER IN PRACTICE, LIKE WHEN WE TRY TO WRITE SOMETHING. BECAUSE I'M WORRIED THAT A REALLY, REALLY GENERAL CONTENT LIST WILL NOT BE USEFUL IN KEY INFORMATION BUT THE QUESTION THEN IS HOW MUCH GOES IN THERE. >> I ABSOLUTELY AGREE AND DON'T WANT TO SEE THE YOU MAY OR MAY NOT BENEFIT KINDS OF GENERAL STATEMENTS BECAUSE THAT'S NOT HELPFUL BUT IT DOES SEEM THERE MAY BE SOME THINGS LIKE, IT'S A PHASE 1 TRIAL. THIS IS THE FIRST TIME WE'RE GIVING IT TO ANYBODY. IT'S GOING--YOU KNOW AND THEN THERE WILL BE SOMETHING ABOUT WHAT WE DO KNOW ABOUT THIS PARTICULAR COMPOUND THAT'S NOW BEING TRIED. BUT I THINK THERE ARE SOME PIECES LIKE THAT WHERE WE COULD THINK, YOU KNOW IN CONTRAST, TOO IF IT'S STANDARD OF CARE, YOU KNOW THAT REALLY IS SEEMS TO ME, IT'S--THESE ARE 2 STANDARD TREATMENTS THAT YOU COULD GET FROM YOUR DOCTOR, THE DIFFERENCE BEING YOUR DOCTOR'S NOT GOING TO CHOOSE, TO SEE THE SPECIFIC RISKS ASSOCIATED WITH THESE, YOU KNOW? I THINK THERE ARE SOME THINGS THAT'S NOT GOING TO RESOLVE EVERYTHING BUT COULD BEGIN TO GIVE--REALLY SOME EXAMPLES OF HOW 1 MIGHT GO ABOUT DOING THIS, THAT MAY BE USEFUL AND THEN IT'S FRAMING SO THAT IT DOESN'T SEEM LIKE THIS IS THE WAY TO GO. >> BUT PAPER--INFORMED CONSENTS GET AMENDED AND CHANGED OVER TIME SO YOU HAVE TO KEEP CHANGING THE--WELL IT'S A LITTLE EXTRA WORK, I GUESS, SO, YEAH, NO. I THINK THAT WE CAN'T IF WE WERE DOING THIS IN ELECTRONIC FORMAT AND WE KNEW THAT, WE WOULD HAVE A LOT OF OPTIONS AND WE WOULD HAVE A LOT OF THINGS THAT WE HAVEN'T TALKED ABOUT AT ALL, THE GRAPHICAL STUFF AND DYNAMIC DISPLAYS AND VIDEOS, AND SO IN SOME WAYS WE'RE LUCKY NOT TO BE DEALING WITH THAT RIGHT NOW. BUT I THINK THAT THE IDEA THAT YOU COULD PUT EXPLICIT LINKS, TAKEN--THEY REFERENCE A PAGE OR A LINE NUMBER OR SOMETHING, HOWEVER IT'S CONSTRUCTED ACTUALLY GIVES US A LITTLE BIT OF LEEWAY WHEN WE THINK SOME PEOPLE THINK THIS IS CRITICAL. SO THE LITMUS TEST SHOULD AGAIN BE FOR THE REASONABLE PERSON OR WHATEVER STANDARD YOU WANT TO USE, WHAT'S IN THE KEY INFORMATION IS WHAT SUPPORTS DECISION MAKING. BUT I THINK THE WHYED THAT YOU HAVE A RELATIVELY DIRECTED REFERENCE TO MORE DETAIL IN THE REST OF THE CONSENT I THINK IS A USEFUL PARADIGM. ANY LAST COMMENTS? >> I DO JUST WANT TO NOTE THAT THE NEXT SACHRP, IN JULY FRANCIS COLLINSEN AND 15 AND IN OCTOBER, AND DETAILS TO BE ANNOUNCED REGARDING THE VIRTUAL PROCESS AND WE MAY ASK YOU TO SPEND A LITTLE BIT OF TIME BEFORE THE MEETING--I DON'T KNOW, I HAVE NO IDEA WHEN THIS WILL BE, WEEKS BEFORE, MONTHS BEFORE ONCE WE A PLATFORM IS ALL OF THIS, JUST PERHAPS INVITE YOU TO A TRAINING SESSION. TRY TO FIND A TIME WHEN WE CAN ALL GET ON AND FIGURE OUT HOW WE RAISE OUR HANDS AND THINGS LIKE THAT. >> THANK YOU. >> THANK YOU. >> SO ANY PUBLIC COMMENT? THERE WAS NONE REGISTERED. ALL RIGHT. THANK YOU ALL AND I GUESS I WON'T SEE YOU IN JULY, BUT I KNOW YOU WILL BE THERE.