{QTText}{font: Arial}{size: 24}{justify: center} {backcolor: 0, 0, 0} {timescale: 100}{width: 300}{height: 0} [00:00:05.43] >>> GOOD MORNING, EVERYONE. [00:00:06.00] WELCOME TO THE FOURTH SESSION OF [00:00:07.80] THIS COURSE. [00:00:08.57] TODAY WE'RE GOING TO TALK ABOUT [00:00:10.30] INFORMED CONSENT, RESEARCH WITH [00:00:13.43] INDIVIDUALS WHO HAVE AN IMPAIRED [00:00:15.63] ABILITY TO GIVE INFORMED [00:00:18.03] CONSENT, AND RESEARCH WITH BIG [00:00:20.10] DATA, WHICH IS ALSO TO SOME [00:00:22.47] EXTENT LARGELY ABOUT INFORMED [00:00:24.90] CONSENT. [00:00:25.20] SO IT WILL BE A DAY OF THINKING [00:00:27.53] ABOUT THOSE ISSUES. [00:00:28.87] I'M GOING TO START, AND AFTER MY [00:00:33.17] USUAL DISCLAIMER, I WANT TO SEE [00:00:34.97] IF I CAN GET YOU GUYS ENGAGED [00:00:36.83] SINCE IT'S EARLY IN THE MORNING. [00:00:38.37] WHO CAN TELL ME WHAT IS INFORMED [00:00:41.93] CONSENT? [00:00:44.80] YOU'VE HEARD OF IT, RIGHT? [00:00:47.20] HAS ANYONE HEARD OF IT? [00:00:51.10] YES? [00:00:51.67] OKAY. [00:00:52.00] WHAT DO YOU THINK IT IS? [00:00:55.60] I'LL SAY ONE THING ABOUT IT. [00:00:57.47] SOMETIMES IF YOU TALK TO PEOPLE [00:00:58.67] ABOUT WHAT MAKES RESEARCH [00:01:00.57] ETHICAL, THE FIRST THING THEY'LL [00:01:02.17] SAY IS INFORMED CONSENT. [00:01:04.60] SO WHAT IS IT? [00:01:05.77] WHAT IS IT? [00:01:09.07] >> I WONDER IF FULLY INFORMED [00:01:11.73] CONSENT IS POSSIBLE. [00:01:13.43] IF THE INVESTIGATORS ARE TRYING [00:01:16.10] TO FIND THINGS OUT, THEY CAN'T [00:01:19.13] FULLY INFORM PARTICIPANTS OF [00:01:24.30] EVERYTHING IN THE STUDY. [00:01:26.17] >> THE GENTLEMAN IN THE FRONT [00:01:27.53] SAYS HE WONDERS IF INVESTIGATORS [00:01:31.97] CAN FULLY INFORM, BECAUSE [00:01:36.07] THEY'RE TRYING TO FIND THE [00:01:39.10] ANSWERS TO ISSUES. [00:01:40.83] BEFORE YOU GET TO THE FULLY PART [00:01:44.90] RAISE YOUR HANDS IF YOU'VE EVER [00:01:47.17] GIVEN INFORMED CONSENT. [00:01:48.30] I WOULD VENTURE TO GUESS THAT A [00:01:49.80] LOT MORE OF YOU HAVE AND MAYBE [00:01:51.50] NOT KNOWN IT. [00:01:52.53] HAVE YOU EVER HELPED TO ASK [00:01:55.00] ANOTHER PERSON FOR THEIR [00:01:56.20] INFORMED CONSENT? [00:01:58.83] SOME HANDS, A FEW HANDS. [00:02:00.87] NOT TOO MANY. [00:02:01.90] HAVE YOU EVER READ A RESEARCH [00:02:04.40] INFORMED CONSENT FORM? [00:02:06.37] A FEW OF YOU HAVE. [00:02:08.17] OKAY. [00:02:08.43] SO IT'S NOT A COMPLETELY CRAZY [00:02:12.30] TERM, RIGHT? [00:02:13.83] IT'S FAMILIAR. [00:02:15.07] WHY DO YOU THINK IT'S IMPORTANT? [00:02:17.90] WHY DO WE DO IT? [00:02:21.53] >> I GUESS FOR BOTH SIDES AS [00:02:24.13] WELL AS THE PATIENT AS WELL AS [00:02:26.03] THE DOCTOR BECAUSE BOTH HAVE TO [00:02:28.43] KNOW WHAT IS GOING ON. [00:02:29.17] >> OKAY, SO BOTH FOR THE PATIENT [00:02:30.87] AND THE DOCTOR, BOTH NEED TO [00:02:32.47] KNOW WHAT'S GOING ON, SO IT'S A [00:02:33.93] WAY TO MAKE THAT HAPPEN. [00:02:35.60] OKAY. [00:02:35.80] ANY OTHER IDEAS ABOUT WHY IT'S [00:02:38.00] IMPORTANT? [00:02:38.27] WHY DO WE SPEND SO MUCH TIME [00:02:40.30] TALKING ABOUT IT AND DOING IT IN [00:02:41.67] THE CONTEXT OF RESEARCH? [00:02:44.10] OR IN CLINICAL CARE, TOO? [00:02:47.03] ANY OTHER IDEAS? [00:02:52.07] BECAUSE THE RULES TELL US WE [00:02:53.33] HAVE TO? [00:02:54.03] IS THAT WHY WE DO IT? [00:02:56.93] >> TO PREVENT EXPLOITATION OF [00:02:59.70] POPULATIONS. [00:03:00.07] >> OKAY, SO TO TRY TO PREVENT [00:03:03.00] EXPLOITATIONS OF VULNERABLE [00:03:04.37] POPULATIONS. [00:03:04.97] AND ONLY VULNERABLE? [00:03:06.87] >> NO. [00:03:07.43] >> MAYBE EVERYBODY, RIGHT? [00:03:10.30] OKAY. [00:03:10.60] ANY OTHER IDEAS? [00:03:14.07] >> I THINK IT ALSO HELPS WITH [00:03:17.73] IMPROVING COMPLIANCE WITH THE [00:03:23.40] PROCESS AND -- [00:03:37.13] [00:03:42.53] SO EVERYBODY UNDERSTANDS. [00:03:43.13] >> SO IF I MAY REFRAME WHAT YOU [00:03:45.13] SAID, IT HAS INSTRUMENTAL VALUE, [00:03:48.63] WHICH AS YOU SAID, IT HELPS [00:03:50.43] PEOPLE COMPLY WITH WHAT THEY'RE [00:03:51.70] BEING ASKED TO DO BECAUSE IT [00:03:52.90] HELPS THEM UNDERSTAND WHAT [00:03:53.60] THEY'RE BEING ASKED TO DO. [00:03:55.73] OKAY. [00:03:56.10] AND HOW DO YOU THINK WE DO? [00:03:57.97] HOW ARE WE DOING? [00:04:01.97] WITH RESPECT TO INFORMED [00:04:03.63] CONSENT, DO YOU INK WE DO A [00:04:04.53] GOOD JOB? [00:04:09.37] IN THE EVENT THAT YOU HAVE [00:04:10.60] EITHER WITNESSED OR BEEN A PART [00:04:12.17] OF, HAS IT GONE AS WELL AS YOU [00:04:14.13] THINK IT SHOULD GO? [00:04:15.73] DO YOU THINK THERE ARE [00:04:16.73] CHALLENGES THAT WE'RE NOT [00:04:22.67] MEETING? [00:04:22.97] >> I THINK IT'S SOMETHING WE [00:04:26.27] DO -- I THINK SOME THINGS WE DO [00:04:27.63] A GOOD JOB. [00:04:28.07] >> OKAY, SOME THINGS WE DO A [00:04:30.03] GOOD JOB. [00:04:30.43] >> YEAH. [00:04:31.30] OTHER THINGS, THEY HAVE A [00:04:32.83] TREMENDOUS CHALLENGE WITH TRYING [00:04:33.53] TO FIGURE OUT HOW MUCH AND HOW [00:04:40.97] BECAUSE WE'RE OVERWHELMING [00:04:42.50] PEOPLE, ESPECIALLY FOR THE MORE [00:04:44.10] COMPLEX. [00:04:44.37] >> THAT'S GREAT. [00:04:51.70] >> SO THE COMMENT WAS WE'RE [00:04:53.83] STRUGGLING WITH HOW MUCH AND HOW [00:04:55.70] BECAUSE SOMETIMES WE'RE [00:04:57.27] OVERWHELMING PEOPLE WITH [00:04:58.10] INFORMATION, ESPECIALLY COMPLEX [00:04:59.60] INFORMATION. [00:04:59.93] THIS IS WHAT I'LL TALK ABOUT, [00:05:01.17] ALL THESE THINGS IN SOME MORE [00:05:02.73] DETAIL. [00:05:02.97] I WANT TO START BY REMINDING US [00:05:05.47] THAT INFORMED CONSENT HAS WHAT [00:05:07.10] PEOPLE CALL A MORALELY [00:05:09.17] TRANSFORMATIVE POWER, SO -- [00:05:11.50] MORALLY TRANSFORMATIVE POWER, SO [00:05:12.90] IT MAKES CERTAIN THINGS [00:05:14.40] ACCEPTABLE THAT ARE OTHERWISE [00:05:15.27] NOT ACCEPTABLE. [00:05:15.97] I'M SURE MANY PEOPLE HAVE BEEN [00:05:17.67] FOLLOWING WHAT'S BEEN HAPPENING [00:05:18.30] ON COLLEGE CAM PULSES IN THE [00:05:19.43] UNITED STATES AND THE WHOLE [00:05:21.00] DISCUSSION -- CAMPUSES IN THE [00:05:22.70] UNITED STATES AND THE WHOLE [00:05:24.00] DISCUSSION ABOUT CONSENSUAL SEX [00:05:26.03] VERSUS RAPE BASICALLY, SO [00:05:27.10] WITHOUT CONSENT, SEX IS RAPE. [00:05:28.90] WITHOUT CONSENT, BORROWING [00:05:31.90] SOMEBODY'S CAR CAN BE ROBBERY. [00:05:36.80] WITHOUT CONSENTED, DRAWING BLOOD [00:05:38.43] ON SOMEBODY CAN BE ASSAULT AND [00:05:40.83] BATTERY. [00:05:41.07] SO CONSENTED MAKES THINGS PER [00:05:43.47] MISCIBLE THAT OTHERWISE ARE NOT. [00:05:50.83] ARE IN THE CONTEXT OF HEALTH AND [00:05:53.57] RESEARCH, WE DON'T JUST TALK [00:05:54.70] ABOUT CONSENT, WE TALK ABOUT [00:05:56.40] INFORMED CONSENT, WHICH MEANS [00:05:57.50] THAT A PERSON AUTHORIZES AN [00:05:59.73] ACTIVITY BASED ON UNDERSTANDING [00:06:00.43] WHAT IT IS, THAT'S WHY THE [00:06:02.13] EMPHASIS ON GIVING INFORMATION [00:06:04.90] ABOUT WHAT WE'RE ASKING THEM TO [00:06:06.23] DO AND THEN ASKING FOR THEIR [00:06:07.93] CONSENT. [00:06:08.27] AND IT IS REQUIRED BYLAWS AND [00:06:12.47] REGULATIONS IN MOST [00:06:16.10] JURISDICTIONS BOTH FOR [00:06:16.87] HEALTHCARE AND FOR RESEARCH. [00:06:18.20] IMPORTANTLY, AND PEOPLE SAY THIS [00:06:19.00] ALL THE TIME, BUT IT'S GOT TO BE [00:06:21.27] SAID EVERY TIME IS THAT IT'S A [00:06:23.77] PROCESS. [00:06:24.00] IT'S NOT JUST A FORM, IT'S NOT [00:06:25.67] JUST AN EPISODE, A ONE-TIME [00:06:28.33] DEAL, IT'S A PROCESS OF REASONS, [00:06:32.73] DECISION-MAKING AND [00:06:33.60] COMMUNICATION, AND IT'S ALSO [00:06:34.33] JUST ONE PART OF MAKING RESEARCH [00:06:36.13] ETHICAL, AS WE'VE TALKED ABOUT [00:06:37.23] ALREADY IN THIS COURSE. [00:06:39.53] WHAT IS IT BASED ON? [00:06:40.70] WHY IS IT IMPORTANT? [00:06:41.70] SOMEONE SAID BEFORE, [00:06:43.33] EXPLOITATION. [00:06:44.03] CERTAINLY THERE'S A VERY STRONG [00:06:47.67] NOTION OF RESPECT FOR PEOPLE'S [00:06:51.70] RIGHT AND CAPACITY TO MAKE [00:06:52.73] DECISIONS ABOUT THEIR OWN LIVES, [00:06:53.97] AND THAT'S A STRONG VALUE THAT [00:06:56.20] WE HAVE IN OUR SOCIETY AND MANY [00:06:58.57] SOCIETIES AROUND THE WORLD. [00:07:01.07] INFORMED CONSENT IS BASED ON [00:07:02.70] THAT. [00:07:02.90] YOU DON'T WANT TO DO THINGS TO [00:07:04.53] PEOPLE WITHOUT THEIR PERMISSION, [00:07:06.83] BUT IT'S BASED ON RESPECTING [00:07:09.40] THEIR RIGHT AND CAPACITY TO MAKE [00:07:11.37] DECISIONS ABOUT THEIR OWN LIVES [00:07:12.93] AND MAKE CHASES THAT ARE [00:07:15.03] COMPATIBLE WITH THOSE LIVES. [00:07:16.23] SO IT'S A PRETTY FUNDAMENTAL [00:07:19.43] VALUE. [00:07:19.83] NOW, IN HEALTHCARE, IN MEDICAL [00:07:21.63] PRACTICE, INFORMED CONSENT IS A [00:07:23.03] VERY IMPORTANT PART OF WHAT [00:07:24.33] HAPPENS. [00:07:24.57] HOW MANY OF YOU KNOW THIS SHOW? [00:07:27.70] OKAY. [00:07:27.90] DO YOU THINK HE GETS GOOD [00:07:29.13] INFORMED CONSENT FROM HIS [00:07:31.20] PATIENTS? [00:07:31.67] [LAUGHTER] [00:07:31.97] I WOULD SAY HE'S PROBABLY THE [00:07:33.37] MODEL OF HOW NOT TO GET INFORMED [00:07:36.77] CONSENT, BUT PROBABLY MOST OF [00:07:37.93] YOU HAVE GONE TO A DOCTOR AT ONE [00:07:39.80] POINT IN YOUR LIFE AND THEREFORE [00:07:42.30] YOU HAVE GIVEN YOUR INFORMED [00:07:44.40] CONSENT TO HAVE WHATEVER IT IS, [00:07:46.93] A TREATMENT, A PROCEDURE, A [00:07:48.77] SURGERY, WHATEVER. [00:07:51.03] I THINK IT'S PRETTY CLEAR THAT [00:07:53.17] WE DON'T DO A GREAT JOB OF [00:07:55.30] INFORMED CONSENT IN HEALTHCARE [00:07:56.67] IN MOST PLACES, AND THERE'S SOME [00:07:58.80] DATA THAT SUGGESTS THAT IT'S [00:08:01.47] FREQUENTLY INADEQUATE. [00:08:02.63] PHYSICIANS ACTUALLY DON'T [00:08:03.53] RECEIVE MUCH TRAINING ON HOW TO [00:08:04.90] GET INFORMED CONSENT. [00:08:06.80] THEY OFTEN UNDERSTAND WHAT [00:08:08.37] THEY'RE REQUIRED TO DO, THERE'S [00:08:09.70] A LOT OF TIME PRESSURE AND [00:08:12.27] COMPETING DEMANDS, PATIENT [00:08:15.30] COMPREHENSION IS OFTEN QUITE [00:08:16.50] POOR WHEN YOU GO BACK AND ASK [00:08:18.37] PEOPLE, AND THERE HAVE BEEN A [00:08:20.50] COUPLE OF RECENT STUDIES THAT [00:08:21.87] HAVE SHOWN IF YOU TEACH [00:08:23.57] COMMUNICATION SKILLS TO [00:08:24.53] PROVIDERS, IT ACTUALLY INCREASES [00:08:25.80] THE UNDERSTANDING ON THE PART OF [00:08:27.60] PATIENTS, WHICH DOESN'T SURPRISE [00:08:29.83] ME, BUT IT'S SORT OF ONE OF [00:08:31.87] THOSE FINDINGS THAT YOU'RE LIKE, [00:08:34.27] REALLY? [00:08:34.50] THEY NEED TO DO A STUDY TO [00:08:35.83] FIGURE THAT OUT? [00:08:37.07] BUT IN RESEARCH, AND THIS IS THE [00:08:39.17] QUESTION I WAS ASKING YOU [00:08:42.20] BEFORE, AS WE ALL KNOW, IN [00:08:44.67] RESEARCH WE ASK PEOPLE TO DO [00:08:48.20] THINGS THAT ARE NOT ALWAYS FOR [00:08:49.87] THEM, THEY'RE FOR ANSWERING [00:08:52.30] QUESTIONS AND FOR ANSWERING [00:08:55.30] IMPORTANT QUESTIONS THAT [00:08:56.40] HOPEFULLY WILL HELP OTHER [00:08:58.57] PEOPLE. [00:08:58.87] SO THEY ARE AT RISK OF [00:09:01.00] EXPLOITATION. [00:09:01.33] THEY ARE AT RISK OF BEING USED [00:09:02.70] FOR THINGS THAT THEY DON'T [00:09:03.83] UNDERSTAND OR THAT THEY DON'T [00:09:05.23] AGREE WITH, AND THEREFORE, IT [00:09:06.83] HAS A SORT OF BIGGER PRESENCE, [00:09:09.27] IF YOU WILL, IN RESEARCH THAN IT [00:09:11.77] DOES IN HEALTHCARE. [00:09:13.00] AND ALMOST ALL THE REGULATIONS [00:09:14.87] AND GUIDANCES AND LAWS THAT HAVE [00:09:17.43] ANYTHING TO DO WITH RESEARCH [00:09:20.07] REQUIRE INFORMED CONSENT FOR [00:09:26.57] RESEARCH. [00:09:28.60] THIS IS JUST WHAT COMES OUT OF [00:09:29.87] THE COMMON RULE AND THE FDA [00:09:31.63] REGS, THE SPECIFIC QUOTE IS: NO [00:09:35.00] INVESTIGATOR MAY INVOLVE A HUMAN [00:09:35.97] BEING AS A SUBJECT IN RESEARCH [00:09:37.50] UNLESS THE INVESTIGATOR HAS [00:09:39.63] OBTAINED THE LEGALLY EFFECTIVE [00:09:41.07] INFORMED CONSENT OF THE SUBJECT [00:09:42.53] OR THE SUBJECT'S LEGALLY [00:09:44.67] AUTHORIZED REPRESENTATIVE. [00:09:46.90] AND THE REGULATIONS ALSO REQUIRE [00:09:48.53] THAT IT HAS TO BE DONE BEFORE [00:09:50.17] THE STUDY STARTS AND IT HAS TO [00:09:52.03] BE DOCUMENTED, SO THOSE ARE THE [00:09:53.73] KINDS OF RULES THAT YOU'RE [00:09:54.83] PROBABLY ALL FAMILIAR WITH AND [00:09:57.47] THAT WE FOLLOW. [00:10:00.80] A VERY USEFUL BOOK, IF YOU'RE [00:10:02.37] INTERESTED IN THIS TOPIC, IS A [00:10:04.37] BOOK WRITTEN BY RUTH SAYDMAN AND [00:10:09.30] TOM BEECHMA -- AND -- FADEN AND [00:10:19.27] BEAUCHAMP, CR THE THEORY OF [00:10:21.07] INFORMED CORN SENT AND WHAT THE [00:10:22.57] CONCEPT IS, AND ONE OF THE [00:10:23.97] THINGS VALUABLE FROM THIS BOOK, [00:10:25.00] THEY TALK ABOUT THERE ARE TWO [00:10:26.83] SORT OF SENSES OF INFORMED [00:10:28.67] CONSENT. [00:10:28.90] FIRST SENSE IS THE AUTONOMOUS [00:10:32.50] AUTHORIZATION, WHERE YOU GIVE [00:10:33.47] PEOPLE INFORMATION SO THEY CAN [00:10:36.73] MAKE CHOICES ARE WITH THEIR OWN [00:10:39.57] INFORMATION AND THEIR OWN LIVES. [00:10:41.10] SECOND IS WHAT IS SORT OF CALLED [00:10:43.43] THE SOCIAL ROLES OF CONSENT. [00:10:44.70] HOW DOES THIS PLAY OUT? [00:10:46.23] YOU MIGHT HAVE WITNESSED OR BEEN [00:10:47.20] PART OF A CONSENT PROCESS WHERE [00:10:50.10] YOU ARE GIVING INFORMATION TO [00:10:52.10] SOMEBODY, THEY HAVE TIME TO [00:10:52.90] THINK ABOUT IT, ASK QUESTIONS, [00:10:54.07] MAKE DECISIONS THAT ARE [00:10:55.47] COMPATIBLE WITH THEIR INTERESTS [00:10:56.37] AND GOALS. [00:10:57.33] THAT'S AUTONOMOUS AUTHORIZATION. [00:10:59.30] YOU MAY HAVE ALSO WITNESSED OR [00:11:01.03] BEEN PART OF A CONSENT PROCESS [00:11:03.50] WHERE SOMEONE SAYS SOMETHING [00:11:05.13] LIKE HURRY UP AND SIGN THIS [00:11:06.63] PIECE OF PAPER BECAUSE THE OR IS [00:11:09.83] WAITING OR, YOU KNOW, SO AND SO [00:11:12.13] WANTS TO GET ON WITH THE [00:11:13.20] TREATMENT OR SOMETHING LIKE [00:11:15.17] THAT, AND, YOU KNOW, THAT CAN BE [00:11:18.00] MORE OR LESS EGREGIOUS, BUT [00:11:20.10] THERE REALLY ARE EXAMPLES, I'M [00:11:21.97] SURE I'VE CERTAINLY WITNESSED [00:11:22.90] SOME AND I'M SURE SOME OF YOU [00:11:24.17] HAVE AS WELL. [00:11:25.90] SO WHAT ARE THE ELEMENTS OF [00:11:27.43] INFORMED CONSENT? [00:11:28.07] THIS IS THE WAY I LIKE TO THINK [00:11:29.63] ABOUT IT BECAUSE I LIKE TO THINK [00:11:31.30] ABOUT NOT ONLY HOW TO DO IT BUT [00:11:35.23] ALSO WHAT ARE THE CHALLENGES, [00:11:37.10] HOW CAN WE DO BETTER. [00:11:38.57] CERTAINLY THERE ARE MULTIPLE [00:11:39.87] ELEMENTS. [00:11:40.13] FIRST PEOPLE HAVE TO HAVE THE [00:11:41.07] CAPACITY TO CONSENT. [00:11:42.20] THEY HAVE TO HAVE THE CAPACITY [00:11:44.47] TO COMMUNICATE, TO UNDERSTAND [00:11:46.30] INFORMATION, TO PROCESS [00:11:47.83] INFORMATION, AND TO MAKE [00:11:49.70] DECISIONS. [00:11:49.97] OUR SECOND SPEAKER TODAY IS [00:11:51.13] GOING TO TALK ABOUT HOW WE DO [00:11:54.03] RESEARCH WITH PEOPLE WHO HAVE [00:11:56.77] IMPAIRED DECISION-MAKING [00:11:58.80] CAPACITY OR IMPAIRED CAPACITY TO [00:12:00.97] GIVE CONSENT. [00:12:01.93] THE NEXT IS DISCLOSURE [00:12:03.67] INFORMATION. [00:12:04.00] WE HAVE TO GIVE PEOPLE [00:12:05.23] INFORMATION, THEY HAVE TO [00:12:05.80] UNDERSTAND IT, THEY HAVE TO MAKE [00:12:08.00] A VOLUNTARY CHOICE, AND THEN [00:12:09.30] THEY HAVE TO AUTHORIZE IT IN [00:12:10.87] SOME WAY, AND AGAIN, USUALLY [00:12:12.87] BECAUSE OF THE RESEARCH [00:12:14.03] REGULATIONS, USUALLY THAT'S A [00:12:15.57] WRITTEN SIGNATURE ON A [00:12:19.30] DOCUMENTLY. [00:12:19.83] SO I'M GOING TO TALK MOSTLY [00:12:22.30] ABOUT THE THREE IN THE MIDDLE, [00:12:24.50] DISCLOSURE INFORMATION, [00:12:25.20] UNDERSTANDING AND VOLUNTARINESS, [00:12:26.80] AND I'M GOING TO START WITH [00:12:28.70] DISCLOSURE. [00:12:29.20] AS WAS SAID EARLIER, ONE OF THE [00:12:31.53] MAJOR CHALLENGES THAT WE HAVE IN [00:12:33.93] INFORMED CONSENT IS WHAT AND HOW [00:12:37.77] MUCH INFORMATION TO DISCLOSE TO [00:12:43.17] PEOPLE. [00:12:43.40] YOU CAN IMAGINE WHEN YOU'RE [00:12:44.20] DOING A RESEARCH STUDY, THE [00:12:46.30] NUMBER OF THINGS YOU COULD TALK [00:12:48.30] ABOUT IN THE RESEARCH STUDY ARE [00:12:50.57] ENORMOUS, AND YET IF YOUR GOAL [00:12:52.00] IS TO GIVE PEOPLE THE [00:12:53.63] INFORMATION THEY NEED TO [00:12:56.03] UNDERSTAND IT ENOUGH TO MAKE A [00:12:58.43] DECISION ABOUT PARTICIPATING OR [00:13:00.07] STAYING IN A STUDY, THAT'S A [00:13:05.63] MATTER OF JUDGMENT. [00:13:07.10] THERE'S ALSO VARIOUS WAYS HOW [00:13:10.10] THE INFORMATION CAN BE [00:13:11.47] PRESENTED, I'LL TALK ABOUT THAT [00:13:12.30] A LITTLE BIT, AND ALWAYS NEEDS [00:13:13.53] TO TAKE INTO ACCOUNT BOTH THE [00:13:15.03] CIRCUMSTANCES OF THE PERSON WHO [00:13:15.97] IS RECEIVING THE INFORMATION BUT [00:13:17.30] ALSO THE SETTING, WHAT KIND OF [00:13:19.00] STUDY IT IS, WHAT KIND OF DURESS [00:13:21.67] PEOPLE ARE UNDER, THAT KIND OF [00:13:26.83] THING. [00:13:27.90] SO WHAT ABOUT INFORMATION? [00:13:28.87] INFORMATION AND INFORMED CONSENT [00:13:30.17] USUALLY IS BOTH WRITTEN AND IN [00:13:32.37] DISCUSSIONS, AND SO YOU'RE ALL [00:13:33.93] FAMILIAR WITH THE WRITTEN [00:13:34.80] CONSENT FORM, WHICH IS SUPPOSED [00:13:37.20] TO BE A SUMMARY OF STUDY [00:13:39.33] INFORMATION AND EXPLANATION [00:13:40.13] ABOUT WHAT THE STUDY IS ABOUT, [00:13:41.43] THE PROCEDURES, THE RISKS, THE [00:13:43.57] BENEFITS, ALTERNATIVES, ET [00:13:45.30] CETERA. [00:13:45.53] THERE ARE ALSO LOTS OF THINGS [00:13:46.90] THAT ARE PART OF THE WRITTEN [00:13:48.60] INFORMATION THAT INDIVIDUALS GET [00:13:50.27] WHEN THEY'RE INTERESTED IN [00:13:51.90] PARTICIPATING IN RESEARCH, AND [00:13:52.97] THESE INCLUDE ADVERTISEMENTS AND [00:13:54.27] FLIERS AND BROCHURES. [00:13:56.27] SOME OF YOU HAVE SEEN THEM ON [00:13:58.97] THE METRO, ON WALLS IN THE [00:14:04.60] CLINICAL CENTER, AND ALL OF [00:14:05.50] THOSE THINGS ARE PART OF THE [00:14:07.30] CONSENT, PART OF THE DISCLOSURE. [00:14:12.33] THERE ARE ALSO LOTS OF [00:14:15.90] INTERACTION INDIVIDUALS HAVE, [00:14:17.30] DISCUSSIONS WITH RESEARCH TEAMS, [00:14:19.17] BUT ALSO WITH OTHER RESEARCH [00:14:22.50] PARTICIPANTS, WITH OTHER KINDS [00:14:24.77] OF SOURCES OF INFORMATION, SO [00:14:26.57] DISCLOSURE COMES IN MANY FORMS. [00:14:29.70] THE REGULATIONS, BOTH THE COMMON [00:14:33.20] RULE AND THE FDA REGULATIONS [00:14:34.83] HAVE A LIST OF THE REQUIRED [00:14:37.23] ELEMENTS OF INFORMED CONSENT. [00:14:38.53] THESE ARE THE THINGS, WHEN [00:14:40.17] WRITING A CONSENT FORM, NEED TO [00:14:41.73] BE INCLUDED IN THE CONSENT FORM. [00:14:43.70] WHEN YOU'RE WORKING IN A [00:14:45.83] REGULATORY OFFICE OR WHEN YOU'RE [00:14:46.67] ON AN IRB, YOU SOMETIMES CHECK [00:14:49.10] TO MAKE SURE THAT ALL THESE [00:14:50.47] THINGS ARE INCLUDED. [00:14:52.03] AND YOU CAN SEE THAT THE LIST IS [00:14:53.90] PRETTY LONG, BUT YOU CAN ALSO [00:14:56.37] IMAGINE THAT THERE ARE DIFFERENT [00:14:58.57] WAYS TO WRITE ABOUT THE PURPOSE [00:15:00.83] OF A STUDY. [00:15:01.90] YOU KNOW, THERE ARE LOTS OF [00:15:03.40] DIFFERENT WAYS YOU COULD EXPLAIN [00:15:04.40] THE PURPOSE OF A STUDY. [00:15:07.97] SO WHEN YOU'RE WRITING A CONSENT [00:15:09.80] FORM, YOU HAVE TO DECIDE WHAT [00:15:10.87] INFORMATION TO INCLUDE ABOUT [00:15:11.87] EACH OF THOSE ELEMENTS, BUT YOU [00:15:13.53] ALSO SHOULD TAKE INTO ACCOUNT [00:15:14.87] THINGS LIKE MAKING IT READABLE [00:15:16.37] AND UNDERSTANDABLE TO THE [00:15:18.47] POPULATION THAT IS LIKELY TO BE [00:15:20.60] READING IT AND HOPING TO [00:15:22.10] UNDERSTAND IT, THERE'S ALSO [00:15:25.10] IMPORTANT REASONS TO PAY [00:15:26.40] ATTENTION TO FORMAT. [00:15:27.23] HAVE YOU EVER LOOKED AT A [00:15:28.47] DOCUMENT WHERE IT'S ALL TEXT [00:15:30.13] WITH NO HEADINGS AND NO WHITE [00:15:32.20] SPACE? [00:15:32.50] THAT'S MUCH HARDER TO READ THAN [00:15:34.03] IT IS IF YOU HAVE WHITE SPACE [00:15:36.67] AND HEADINGS AND SPACES BETWEEN [00:15:42.23] PARAGRAPHS. [00:15:42.53] SO I WANT YOU JUST TO TAKE A [00:15:44.20] MINUTE AND READ THESE TWO [00:15:47.83] PARAGRAPHS, THEN I'M GOING TO [00:15:48.70] ASK YOU A QUESTION. [00:16:10.93] ALL RIGHT. [00:16:11.67] SO THESE ARE TWO WAYS OF [00:16:16.63] DESCRIBING THE PURPOSE OF A [00:16:21.53] STUDY. [00:16:21.73] HOW MANY OF YOU LEARNED [00:16:23.00] SOMETHING DIFFERENT FROM ONE [00:16:24.00] VERSUS THE OTHER? [00:16:30.10] SO DO YOU FEEL LIKE YOU DID? [00:16:32.37] OKAY. [00:16:32.57] WHAT'S DIFFERENT? [00:16:36.07] >> HOW THE DRUG WORKS. [00:16:38.50] >> Christine Grady: HOW THE DRUG [00:16:39.27] WORKS, OKAY, SO THE MECHANISM OF [00:16:41.90] ACTION OF THE DRUG IS IN ONE AND [00:16:43.20] NOT THE OTHER. [00:16:44.20] ANYTHING ELSE DO YOU SEE THAT'S [00:16:45.47] DIFFERENT? [00:16:48.33] SO I GUESS THE QUESTION IS WHAT [00:16:51.23] YOU'RE TRADING OFF. [00:16:51.83] YOU KNOW, THE MECHANISM OF THE [00:16:54.57] DRUG, IF YOU LOOK AT THE [00:16:56.57] READABILITY STATISTICS OF THESE [00:16:57.80] TWO, ONE IS ABOUT 11TH GRADE AND [00:17:00.67] ONE IS ABOUT 6TH GRADE, AND THE [00:17:03.27] NUMBER OF WORDS IS ABOUT THREE [00:17:05.80] TIMES OR TWICE, I FORGET, I HAD [00:17:07.60] IT WRITTEN DOWN, BUT I DON'T [00:17:09.30] REMEMBER, SO THE QUESTION IS [00:17:11.00] HAVE YOU MADE IT EASIER FOR [00:17:13.67] SOMEONE TO UNDERSTAND AT THE [00:17:14.97] EXPENSE OF SOMETHING THEY REALLY [00:17:16.83] NEED TO KNOW, OR HAVE YOU MADE [00:17:18.30] IT EASIER FOR THEM TO UNDERSTAND [00:17:20.20] AT THE EXPENSE OF SOMETHING [00:17:22.00] THAT'S PROBABLY NOT THAT [00:17:22.77] RELEVANT TO THEIR DECISION? [00:17:23.73] THAT'S THE QUESTION THAT NEEDS [00:17:25.40] TO BE SORT OF ENTERTAINED WHEN [00:17:27.17] YOU'RE TRYING TO WRITE CONSENT [00:17:29.63] FORMS. [00:17:29.90] SO WHAT DO WE KNOW ABOUT CONSENT [00:17:32.17] FORMS? [00:17:32.40] FIRST OF ALL, WE KNOW THAT [00:17:33.97] ALMOST ALWAYS THE READABILITY IS [00:17:36.50] REALLY HIGH. [00:17:37.43] THERE'S BEEN A LOT OF STUDIES TO [00:17:39.00] SHOW THIS. [00:17:39.83] THEY'RE WRITTEN ABOUT THE 11TH [00:17:41.50] GRADE LEVEL OR HIGHER, WHEREAS [00:17:42.83] THE MEDIAN READING LEVEL IN THE [00:17:44.53] UNITED STATES IS 8TH GRADE. [00:17:48.40] CONSENT FORMS ARE LONG AND [00:17:50.67] GETTING LONGER. [00:17:51.30] HOW MANY OF YOU HAVE SEEN A [00:17:53.90] CONSENT FORM THAT'S 15 PAGES [00:17:57.00] LONG? [00:17:57.67] YEAH, MOST. [00:17:58.67] I'VE SEEN THEM THAT ARE 30 PAGES [00:18:00.93] LONG. [00:18:01.13] I MEAN, THEY'RE REALLY LONG, AND [00:18:05.00] I'M ALMOST -- AND I'VE ALMOST [00:18:06.40] NEVER SEEN ONE THAT'S LESS THAN [00:18:07.83] FIVE PAGES LONG, BUT THEY ARE [00:18:09.03] LONG, AND THEY'RE GETTING LONGER [00:18:10.13] OVER TIME, AT LEAST THE DATA [00:18:13.40] SUGGESTS. [00:18:13.80] NONETHELESS, EVEN LONG AND [00:18:14.93] COMPLEX, THEY'RE OFTEN MISSING [00:18:16.33] THINGS. [00:18:17.27] THEY DON'T ALWAYS HAVE THE [00:18:20.07] THINGS THAT PEOPLE FIND [00:18:21.77] IMPORTANT TO INCLUDE OR THE [00:18:23.40] REGULATIONS INCLUDE. [00:18:27.67] MARK HOCKHOUSER HAS DONE WORK ON [00:18:33.63] CON SEBILITY FORMS AND HE PUT [00:18:36.70] THIS CHART, WHICH IS USEFUL, HOW [00:18:38.10] LONG IT TAKES TO READ A CERTAIN [00:18:39.77] NUMBER OF WORDS. [00:18:41.13] WHEN WE THINK ABOUT GIVING [00:18:42.33] PEOPLE CONSENT FORM, WE'RE [00:18:43.80] ASKING THEM TO READ THEM, AND [00:18:46.70] SLOW READERS VERSUS AVERAGE [00:18:48.03] READERS, I TOOK A RANDOMLY [00:18:49.87] SELECTED CONSENT FORM FROM THE [00:18:53.77] INTRAMURAL PROGRAM AND IT WAS [00:18:55.33] NOT EASTERN 12,000 WORDS, IT WAS -- IT WAS NOT EVEN 12,000 [00:18:58.83] WORDS, IT WAS ABOUT 14,000 [00:19:00.63] WORDS, WHAT SKIER -- WHAT KEIR [00:19:03.53] ASKING PEOPLE TO DO IS AT LEAST [00:19:05.23] TAKE 40 MINUTES BUT MAYBE UP TO [00:19:07.13] TWO HOURS TO READ THE CONSENT [00:19:09.50] FORM THAT WE'RE WRITING FOR [00:19:11.70] THEM. [00:19:11.90] AND I DON'T KNOW ABOUT YOU, BUT [00:19:13.53] UNLESS PEOPLE ARE GIVING THEM [00:19:15.10] BEFORE THEY COME IN OR TAKE THEM [00:19:16.53] HOME WITH THEM, WE DON'T GIVE [00:19:18.13] THEM TWO HOURS IN THE CLINIC TO [00:19:19.60] SIT THERE AND READ IT, THAT'S [00:19:28.07] FOR SURE. [00:19:28.97] IT'S ACTUALLY HARD TO WRITE [00:19:30.17] SIMPLE CONSENT FORMS, HARD TO [00:19:31.70] WRITE THEM AT LOW READING [00:19:33.57] LESTLEDZ, AND THERE WAS A [00:19:35.10] QUOTE -- LEVELS, AND THERE WAS A [00:19:36.40] QUOTE I FOUND, IT'S HARD TO [00:19:38.03] COMMUNICATE CLEARLY, EASY [00:19:39.97] READING IS DAMN HARD WRITING, IT [00:19:43.50] WAS ATTRIBUTED TO BOTH NATHANIEL [00:19:47.87] HAWTHORNE IN 1840 AND ALSO MAYA [00:19:50.30] ANGELOU IN 2000, SOMEBODY SAID [00:19:52.30] IT, IT'S STILL TRUE, TO BE ABLE [00:19:53.67] TO WRITE SOMETHING SIMPLY TAKES [00:19:54.83] SOME WORK, IT TAKES SOME EFFORT, [00:19:56.60] IT'S NOT AN EASY THING AND [00:19:58.40] PEOPLE ARE NOT WELL PRACTICED ON [00:20:01.50] IT. [00:20:01.87] IT'S ALSO TRUE THAT CONSENT [00:20:03.20] FORMS HAVE OTHER FUNCTIONS [00:20:04.70] BESIDES INFORMING THE [00:20:06.67] PARTICIPANTS. [00:20:07.33] THEY DO PROTECT THE SPONSOR, THE [00:20:10.83] INVESTIGATOR, THE INSTITUTION, [00:20:11.83] ET CETERA, AND SOMETIMES THERE [00:20:13.77] IS LANGUAGE THAT THE INSTITUTION [00:20:16.03] REQUIRES IN CONSENT FORMS AND [00:20:20.13] IT'S ACTUALLY IRONIC BUT TRUE [00:20:21.87] THAT IRB'S WHO ARE GENERALLY [00:20:27.77] TASKED WITH PROTECTING [00:20:29.70] PARTICIPANTS, WHICH WOULD [00:20:30.23] INCLUDE MAKING SURE THAT THEY [00:20:31.13] UNDERSTAND WHAT THEY'RE AGREEING [00:20:32.60] TO, I WOULD ARGUE, OFTEN MAKE [00:20:35.40] CONSENT FORMS LONGER AND MORE [00:20:36.93] COMPLICATED RATHER THAN LESS. [00:20:41.40] THERE IS SOME GUIDANCE WHICH I [00:20:42.77] THINK IS REALLY HELPFUL BUT RNT [00:20:44.83] OFTEN KNOWN ABOUT -- BUT NOT [00:20:46.67] OFTEN KNOWN ABOUT, THIS IS [00:20:47.93] PRETTY STANDARD, EASY LANGUAGE [00:20:50.13] GUIDANCE, THIS IS FROM NCI WHO [00:20:51.57] PUT TOGETHER A BUNCH OF [00:20:52.63] DOCUMENTS ON HOW TO SIMPLIFY [00:20:54.47] CONSENT FORMS. [00:20:57.20] THINGS LIKE MAKING -- WRITING IN [00:21:02.70] THE ACTIVE VOICE, RATHER THAN [00:21:03.70] PASSIVE VOICE, WRITING SHORTER [00:21:06.03] SENTENCES RATHER THAN LONGER [00:21:06.93] SENTENCES, NOT REPEATING THINGS [00:21:08.63] TOO OFTEN, THAT KIND OF THING, [00:21:10.17] USING FORMATS, BULLETS, TABLES, [00:21:11.77] THINGS LIKE THAT SOMETIMES ARE [00:21:12.93] VERY HELPFUL. [00:21:17.47] THERE ARE ALSO INTERESTING [00:21:18.77] ISSUES ABOUT PRESENTATION, NOT [00:21:19.90] JUST WHAT'S IN THE DOCUMENT, NOT [00:21:21.47] JUST THE WORDS AND THE CHOICES [00:21:24.97] OF HOW YOU WRITE WORDS, BUT HOW [00:21:27.63] THINGS ARE PRESENTED TO [00:21:29.17] PARTICIPANTS. [00:21:29.50] YOU CAN USE A CONSENT FORM IN [00:21:30.67] LOTS OF WAYS, YOU CAN HAND IT TO [00:21:32.77] SOMEBODY AND SAY READ T DO YOU [00:21:34.83] HAVE ANY QUESTIONS, YOU CAN GO [00:21:35.87] OVER IT LINE BY LINE, YOU CAN [00:21:38.00] SUMMARIZE T OR YOU CAN JUST GIVE [00:21:39.17] IT TO SOMEBODY AS A REFERENCE [00:21:40.30] AND DESCRIBE IN OTHER TERMS WHAT [00:21:42.67] THE PROCESS, THE STUDY IS ABOUT. [00:21:45.53] AND I'VE SEEN ALL OF THOSE [00:21:47.37] VERSIONS OF USING THE CONSENT [00:21:49.73] FORM. [00:21:49.93] THERE'S ALSO LOTS OF INTERESTING [00:21:51.03] THINGS ABOUT THE WAY WE PRESENT [00:21:53.00] INFORMATION THAT HAVE NOTHING TO [00:21:54.63] DO WITH THE WORDS BUT HAVE TO DO [00:21:56.27] WITH BODY LANGUAGE AND WHERE [00:21:57.87] PEOPLE ARE SITTING AND HOW MANY [00:21:59.27] PEOPLE ARE IN THE ROOM AND [00:22:01.00] THINGS LIKE THAT THAT IMPACT THE [00:22:04.80] KINDS OF INFORMATION THAT GETS [00:22:06.67] DISCLOSED. [00:22:06.93] SO FOR EXAMPLE, MY FAVORITE [00:22:08.30] STORY, AND SOME OF YOU I [00:22:09.73] APOLOGIZE HAVE HEARD THIS [00:22:11.47] BEFORE, A LONG TIME AGO, [00:22:12.97] WITNESSING A CONSENT PROCESS [00:22:14.33] WHERE THERE WAS A YOUNG MAN, [00:22:16.93] VERY SHY, VERY NONVERBAL, [00:22:19.73] SITTING AND HAD A VERY SERIOUS [00:22:21.33] DISEASE AND WAS LEARNING ABOUT A [00:22:24.63] VERY COMPLICATED STUDY, HE WAS [00:22:26.77] SITTING IN A CONFERENCE ROOM AT [00:22:28.33] A TABLE, HIS AUNT WAS WITH HIM, [00:22:31.37] AND THERE WERE THREE PHYSICIANS. [00:22:33.50] THEY DID NOT SILT DOWN. [00:22:34.83] THEY ALL -- THEY DID NOT SIT [00:22:36.27] DOWN. [00:22:36.47] THEY ALL STOOD, THEY ALL HAD [00:22:39.30] PAGERS ON, WHICH KEPT GOING OFF, [00:22:40.77] SO ONE OR THE OTHER WOULD BE [00:22:42.40] LEAVING THE ROOM AND COMING BACK [00:22:43.50] AND PICKING UP WHERE THEY LEFT [00:22:44.97] OFF, AND THEY WERE EXQUISITE IN [00:22:47.53] THEIR COMPREHENSIVENESS, THEY [00:22:49.00] TOLD HIM EVERYTHING, MECHANISM [00:22:50.23] OF ACTION, EVERYTHING ABOUT THIS [00:22:54.13] STUDY, BUT THE BODY LANGUAGE, HE [00:22:56.43] WAS SITTING HERE AND THEY WERE [00:22:58.03] LIKE -- I MEAN, THIS IS MY [00:22:59.63] IMAGE, THEY WERE LIKE, AHH OVER [00:23:02.70] HIM, AND IT WAS JUST LIKE [00:23:04.27] INFORMATION, INFORMATION, [00:23:04.93] INFORMATION, AND THEN THEY SAID, [00:23:06.27] WHAT DO YOU THINK? [00:23:11.73] AND THAT IS NOT THE IDEAL WAY TO [00:23:13.90] DISCLOSE INFORMATION TO SOMEBODY [00:23:14.77] WHO IS ALREADY UNDERGOING SOME [00:23:19.40] STRESS. [00:23:19.73] THERE'S ALSO SOME INTERESTING [00:23:21.80] QUESTIONS ABOUT WHAT IN THE [00:23:25.97] DISCUSSIONS THAT THE STUDY TEAMS [00:23:27.50] HAVE, WHAT THEY EMPHASIZE WITH [00:23:29.73] PARTICIPANTS. [00:23:30.07] THERE HAVE BEEN VERY FEW [00:23:31.30] STUDIES, BUT THIS IS ONE STUDY [00:23:34.03] WE DID YEARS AGO WHERE WE ASKED [00:23:36.43] INVESTIGATORS WHAT DO YOU DO [00:23:38.40] WHEN YOU ARE GETTING CONSENT [00:23:39.57] FROM SOMEBODY? [00:23:40.53] AND THESE ARE SOME OF THE THINGS [00:23:41.70] THAT THEY TOLD US. [00:23:43.17] THEY'RE ACTUALLY PRETTY GOOD [00:23:44.70] ABOUT GIVING SOMEBODY A COPY OF [00:23:46.53] THE CONSENT FORM AND THE [00:23:48.83] OPPORTUNITY TO READ IT BEFORE [00:23:50.80] THEY GET TO THE CLINIC, BUT SOME [00:23:52.60] THINGS THEY DON'T EMPHASIZE. [00:23:54.07] LOOK AT RANDOMIZATION, LESS [00:23:56.77] THAN, ABOUT 50% EMPHASIZE [00:24:00.13] RANDOMIZATION, AND ONLY 8.6% HAD [00:24:03.57] ANY FORMAL WAY OF ASSESSING [00:24:05.27] WHETHER THE PERSON UNDERSTOOD [00:24:07.30] THE INFORMATION THAT WAS [00:24:12.00] PROVIDED. [00:24:12.47] SETTINGS, I ALREADY SORT OF SAID [00:24:14.30] THIS, BUT THEY REALLY MATTER. [00:24:15.50] I MEAN, IF YOU'RE IN THE [00:24:19.20] SCENARIO LIKE THIS, BOTH THE [00:24:21.90] AMOUNT OF INFORMATION THAT YOU [00:24:23.33] MIGHT THINK ABOUT PROVIDING AND [00:24:25.30] HOW YOU PROVIDE IT ARE GOING TO [00:24:26.77] BE VERY DIFFERENT THAN IF YOU'RE [00:24:28.57] HERE, RIGHT? [00:24:29.80] THEY SHOULD BE. [00:24:32.17] OTHERWISE, IT'S CRAZY TO THINK [00:24:33.37] THAT IT HAS ANY EFFECT. [00:24:34.93] HOW ABOUT THIS ONE? [00:24:35.90] I MEAN, THIS IS PROBABLY A [00:24:40.00] LITTLE EXAGGERATED, BUT I HAVE [00:24:42.13] SEEN SOME PARTICIPANTS OVER TIME [00:24:44.60] WHO SORT OF ZONE OUT. [00:24:45.83] YOU KNOW, THE INFORMATION IS TOO [00:24:47.60] MUCH, THE SITUATION IS TOO MUCH, [00:24:49.67] THE WHOLE -- YOU KNOW, IT'S JUST [00:24:51.40] TOO MUCH, AND YOU CAN TELL [00:24:52.83] THEY'RE NOT LISTENING TO [00:24:55.13] ANYTHING THAT THE TEAM IS [00:24:56.27] TELLING THEM. [00:24:58.73] AND YET THIS IS SOME COLLEAGUES [00:25:00.70] IN YU BEGAN DA WHO GAVE ME THIS, [00:25:02.83] YOU KNOW, YOU DON'T HAVE TO HAVE [00:25:05.03] FANCY CONFERENCE ROOMS, YOU CAN [00:25:05.97] HAVE IN CREATIVE WAYS SETTINGS [00:25:07.53] THAT ARE VERY AMENABLE TO [00:25:09.40] DISCLOSING INFORMATION IN [00:25:10.47] DIFFERENT CONTEXTS. [00:25:12.63] THIS WAS IN YUGANDA. [00:25:16.53] SO DISCLOSURE, TO SUMMARIZE THAT [00:25:18.83] PART, WHAT INFORMATION, WHERE [00:25:19.90] THE INFORMATION IS GIVEN, WHO [00:25:21.53] GIVES IT, WHEN IT'S GIVEN AND [00:25:26.70] HOW IT'S GIVEN ALL MATTER IN [00:25:28.13] TERMS OF INFORMATION TRANSFER. [00:25:32.63] CONSENT DOCUMENTS USUALLY [00:25:33.53] INCLUDE RELEVANT INFORMATION BUT [00:25:34.40] THEY'RE USUALLY TOO LONG AND TOO [00:25:37.43] COMPLICATED. [00:25:37.93] THERE'S VERY LITTLE INFORMATION [00:25:39.53] ABOUT HOW INVESTIGATORS DISCLOSE [00:25:42.87] INFORMATION. [00:25:43.17] I THINK PROBABLY EACH OF YOU [00:25:44.30] HAVE A STORY ABOUT THAT, AND THE [00:25:46.50] TRAINING FOR INVESTIGATORS IS [00:25:48.13] FAIRLY LIMITED, ALTHOUGH IN THE [00:25:49.97] INTRAMURAL PROGRAM THERE IS A [00:25:52.73] COURSE ON HOW TO GIVE INFORMED [00:25:55.00] CONSENT BASICALLY OR HOW TO [00:25:56.60] OBTAIN -- I FORGET WHAT IT'S [00:25:57.80] CALLED, IT'S OFFERED REGULARLY, [00:25:59.10] THREE OR FOUR TIMES A YEAR. [00:26:00.43] IF YOU'RE INTERESTED IN THAT, I [00:26:01.97] CAN GIVE YOU INFORMATION. [00:26:03.03] SO WHAT ABOUT UNDERSTANDING? [00:26:04.90] THAT'S ALL ABOUT HOW WE GIVE [00:26:06.27] PEOPLE INFORMATION. [00:26:06.80] BUT IF WE'RE REALLY TALKING [00:26:08.23] ABOUT AN AUTONOMOUS [00:26:10.50] AUTHORIZATION, AS INFORMED [00:26:11.73] CONSENT, WE WANT PEOPLE TO [00:26:12.30] UNDERSTAND IT, RIGHT? [00:26:14.33] SO STUDIES HAVE CONTINUED TO [00:26:16.03] SHOW THAT RESEARCH PARTICIPANTS [00:26:17.60] ACTUALLY HAVE A FAIRLY LIMITED [00:26:19.97] OR AT LEAST VARIABLE [00:26:23.27] UNDERSTANDING OF INFORMATION [00:26:24.20] THAT'S GIVEN TO THEM IN THE [00:26:25.60] CONTEXT OF INFORMED CONSENT, AND [00:26:27.63] THERE ARE A NUMBER OF STUDIES [00:26:29.37] THAT SOMETIMES BREAK IT DOWN [00:26:30.73] INTO THE PURPOSE AND THE NATURE [00:26:32.43] OF RESEARCH, HOW WELL PEOPLE [00:26:34.00] UNDERSTAND THAT, YOU CAN SEE THE [00:26:36.40] RANGE, RESEARCH RISKS, SIMILAR [00:26:38.13] RANGE, AND THINGS LIKE [00:26:39.90] RANDOMIZATION WHICH ARE ACTUALLY [00:26:41.43] AT LEAST BY EMPIRICAL DATA [00:26:43.77] HARDER FOR PEOPLE TO UNDERSTAND [00:26:45.03] OR LESS WELL UNDERSTOOD I GUESS [00:26:46.43] IS THE BETTER DESCRIPTOR, [00:26:49.93] PROBABLY BECAUSE IT'S UNUSUAL, [00:26:51.57] RIGHT? [00:26:51.77] WHAT IS RANDOMIZATION? [00:26:54.57] IT'S NOT A FAMILIAR CONCEPT [00:26:57.43] OUTSIDE OF RESEARCH. [00:26:59.87] ARE THIS IS A META-ANALYSIS THAT [00:27:01.87] WAS PUBLISHED IN 2015 WHICH HAS, [00:27:04.70] I FORGET HOW MANY STUDIES WERE [00:27:06.13] INCLUDED, BUT WHAT I WANT YOU TO [00:27:07.27] SEE ABOUT THIS IS IF THEY BREAK [00:27:09.73] DOWN ALL THE DIFFERENT THINGS [00:27:11.00] THAT YOU MIGHT WANT SOMEBODY TO [00:27:12.73] UNDERSTAND, NONE OF THEM EVEN [00:27:14.73] GET CLOSE TO 100%, AND SOME OF [00:27:18.10] THEM ARE MORE LIKE 50%. [00:27:20.37] AGAIN, RANDOMIZATION AND [00:27:22.10] PLACEBO. [00:27:22.33] THE WURCH THAT SOMETIMES -- THE [00:27:23.90] ONE THAT SOMETIMES PEOPLE FIND [00:27:25.40] THE MOST PROBLEMATIC ARE THESE, [00:27:29.07] PARTICIPATING IS VOLUNTARY, THAT [00:27:30.67] PEOPLE CAN WITHDRAW AT ANY TIME, [00:27:32.07] AND IN STUDY AFTER STUDY, IT [00:27:34.07] HOVERS AROUND 70 OR 80%, WHICH, [00:27:36.60] YOU KNOW, SOME PEOPLE SAY, WELL, [00:27:38.67] THAT'S PRETTY GOOD, OTHER PEOPLE [00:27:40.20] SAY THAT'S TERRIBLE. [00:27:41.17] HOW CAN 20% OF PEOPLE NOT KNOW [00:27:43.03] THAT THIS IS A VOLUNTEER VOLUNTARY CHOICE? [00:27:46.57] SO CHALLENGES. [00:27:47.50] THERE ARE LOTS OF CHALLENGES TO [00:27:49.60] HOW WE THINK ABOUT UNDERSTANDING [00:27:51.97] IN THE CONTEXT OF INFORMED [00:27:54.47] CONSENT. [00:27:54.70] THERE ARE LOTS OF THINGS THAT [00:27:56.10] AFFECT HOW PEOPLE UNDERSTAND [00:28:00.43] INFORMATION. [00:28:00.77] WE HAVE DISAGREEMENT ABOUT HOW [00:28:05.33] UNDERSTANDING SHOULD BE ASSESSED [00:28:06.90] OR WHETHER IT SHOULD BE [00:28:08.80] ASSESSED, I SHOULD SAY. [00:28:09.67] WE ALSO HAVE DISAGREEMENT ABOUT [00:28:11.20] HOW MUCH PARTICIPANTS OUGHT TO [00:28:13.03] UNDERSTAND IN ORDER TO GIVE [00:28:14.37] VALID INFORMED CONSENT, AND WE [00:28:17.47] HAVE SOME DISAGREEMENT BUT ALSO [00:28:19.23] I THINK VARIABILITY OF PRACTICE [00:28:21.33] ABOUT WHAT HAPPENS WHEN SOMEBODY [00:28:23.93] DOESN'T UNDERSTAND. [00:28:24.60] WHAT DO WE DO? [00:28:27.03] SO WHAT ARE THE THINGS AAFFECT [00:28:29.27] UNDERSTANDING? [00:28:30.37] WELL, CERTAINLY THERE ARE HOST [00:28:31.67] FACTORS LIKE AGE AND EDUCATION [00:28:34.70] AND PAIN AND COGNITIVE CAPACITY, [00:28:36.97] AND THE ONES THAT I'VE STARRED [00:28:38.30] UP THERE ARE ONES FOR WHICH [00:28:40.07] THERE IS DATA TO SHOW THAT [00:28:42.80] UNDERSTANDING ACTUALLY VARIES [00:28:43.43] WITH AGE AND EDUCATION AND [00:28:46.67] COGNITIVE CAPACITY. [00:28:47.50] BUT THERE ARE OTHER THINGS THAT [00:28:49.00] AFFECT UNDERSTANDING. [00:28:50.73] CERTAINLY EXPECTATIONS AND [00:28:52.03] TRUST. [00:28:52.27] THERE'S BEEN SOME DATA TO SHOW, [00:28:53.80] FOR EXAMPLE, THAT SOME RESEARCH [00:28:56.97] PARTICIPANTS WHO SAY THEY TRUST [00:28:58.77] THEIR DOCTORS OR THEY TRUST THE [00:29:02.70] RESEARCH DOCTORS SPEND LESS TIME [00:29:05.20] PAYING ATTENTION ON THE [00:29:05.87] INFORMATION THEY'RE GIVEN IN THE [00:29:06.83] PROCESS OF INFORMED CONSENT [00:29:08.37] SAYING I DON'T CARE ABOUT THAT, [00:29:09.30] I JUST TRUST THEM TO TELL ME [00:29:10.77] WHAT TO DO. [00:29:11.37] SO THAT AFFECTS THEIR ABILITY TO [00:29:13.27] UNDERSTAND. [00:29:13.70] THE THERAPEUTIC MISCONCEPTION [00:29:16.03] AND OTHER KINDS OF [00:29:17.30] MISUNDERSTANDINGS, WHICH I'LL [00:29:18.07] COME BACK TO IN A SECOND, AND [00:29:19.70] THEN OF COURSE PROCESS-RELATED [00:29:21.47] FACTORS, YOU KNOW, HOW MUCH [00:29:22.30] INFORMATION IS GIVEN TO THEM AND [00:29:23.70] WHETHER OR NOT THEY LISTEN OR [00:29:26.83] READ OR THOSE THINGS, THAT [00:29:28.50] INFLUENCES HOW MUCH THEY [00:29:31.10] UNDERSTAND. [00:29:31.40] THERE ARE LOTS OF OTHER [00:29:33.77] CHALLENGES HERE. [00:29:34.77] SCIENCE IS COMPLICATED. [00:29:36.23] THERE'S NO DOUBT THAT IT'S [00:29:39.17] COMPLICATED. [00:29:39.50] I CERTAINLY READ SOME SCIENTIFIC [00:29:41.03] THINGS AND I DON'T UNDERSTAND [00:29:42.07] THEM, AND I'VE GOT LOTS OF [00:29:44.30] EDUCATION IN SCIENCE. [00:29:46.07] SO IMAGINE A PERSON WHO DOESN'T [00:29:47.47] HAVE ANY SCIENCE EDUCATION [00:29:48.80] TRYING TO READ SOME OF THE [00:29:50.10] INFORMATION THAT WE PROVIDE. [00:29:52.13] WE ALSO KNOW THAT HEALTH [00:29:53.80] LITERACY AND SCIENCE LITERACY [00:29:56.43] TOO IS PRETTY LIMITED. [00:29:58.93] DATA IS PRETTY BLEAK, ACTUALLY, [00:30:01.13] ABOUT HOW MANY PEOPLE UNDERSTAND [00:30:02.63] HEALTH AND SCIENCE. [00:30:07.33] THERE'S ALSO INTERESTING [00:30:08.00] QUESTIONS ABOUT HOW TO MEASURE [00:30:09.53] UNDERSTANDING. [00:30:09.87] HOW DO YOU ACTUALLY KNOW WHETHER [00:30:11.27] SOMEBODY UNDERSTANDS? [00:30:12.67] IT'S INTERESTING TO WATCH, YOU [00:30:14.03] KNOW, DIFFERENT CONSENT [00:30:15.70] PROCESSES. [00:30:16.03] SOMETIMES WHAT HAPPENS IS YOU [00:30:17.67] GIVE PEOPLE THE INFORMATION, YOU [00:30:19.70] GIVE THEM TIME TO READ THE FORM [00:30:20.93] AND THEN YOU SAY, DO YOU HAVE [00:30:22.00] ANY QUESTIONS? [00:30:22.50] AND IF THEY DON'T ASK QUESTIONS, [00:30:24.33] THE ASSUMPTION IS THEY [00:30:26.57] UNDERSTAND. [00:30:26.90] NOW, IN SOME CASES THAT'S [00:30:28.10] PROBABLY OKAY. [00:30:28.70] IN OTHER CASES IT'S PROBABLY [00:30:31.00] NOT. [00:30:31.27] BUT WE GO FROM THERE TO IN SOME [00:30:35.40] STUDIES WRITTEN TESTS, WRITTEN [00:30:37.37] QUIZZES. [00:30:37.63] YOU HAVE TO PASS THE QUIZ IN [00:30:40.00] ORDER TO SHOW YOU UNDERSTAND IT [00:30:41.97] ENOUGH TO BE ENROLLED IN THE [00:30:44.63] STUDY. [00:30:44.87] THERE ARE DIFFERENT KINDS OF [00:30:48.17] MISUNDERSTANDING. [00:30:48.53] SO HOW MANY OF YOU HAVE HEARD [00:30:49.50] ABOUT THE THERAPEUTIC [00:30:52.47] MISCONCEPTION? [00:30:52.83] PEOPLE TALK ABOUT IT ALL THE [00:30:54.90] TIME. [00:30:55.10] I THINK THERE'S A WAY OF -- [00:30:57.67] ACTUALLY THIS IS A FELLOW FROM [00:31:00.10] SOME YEARS AGO AND I WROTE A [00:31:02.40] PAPER WHERE WE TRIED TO [00:31:06.23] DISENTANGLE MISCONCEPTION FROM [00:31:07.37] TWO OTHER KINDS OF [00:31:08.57] MISUNDERSTANDING THAT SEEM TO BE [00:31:09.50] COMMON IN RESEARCH. [00:31:11.97] MISCONCEPTION BEING THAT YOU [00:31:13.63] DON'T UNDERSTAND THAT RESEARCH [00:31:14.93] IS DIFFERENT FROM WHAT YOU MIGHT [00:31:17.37] BE -- WHAT MIGHT BE HAPPENING IF [00:31:18.27] YOU WENT TO A DOCTOR SOMEWHERE [00:31:20.03] ELSE, THAT YOU'RE GETTING [00:31:21.97] PERSONALIZED ATTENTION, THAT [00:31:22.53] IT'S BEING DONE FOR YOUR [00:31:23.93] BENEFIT, THAT KIND OF THING. [00:31:26.10] THAT'S THE SORT OF MISCONCEPTION [00:31:28.40] ABOUT WHAT RESEARCH IS, WHICH IS [00:31:30.67] DIFFERENT THAN MISESTIMATION [00:31:32.33] WHICH IS ALSO VERY COMMON WHICH [00:31:33.63] IS, YOU KNOW, JUST [00:31:35.07] OVERESTIMATING THE BENEFITS AND [00:31:36.83] UNDERESTIMATING THE RISKS OR [00:31:39.83] VICE VERSA, IT HAPPENS THE OTHER [00:31:41.10] WAY TOO, YOU OVERESTIMATE THE [00:31:43.23] RISK, WHICH IS ALSO DIFFERENT, I [00:31:44.43] THINK, FROM WHAT WE CALLED [00:31:46.10] OPTIMISM, WHICH IS SOME PEOPLE [00:31:47.40] WILL SAY I KNOW EXACTLY THE DATA [00:31:50.60] ON RISKS AND BENEFITS AND THEY [00:31:52.00] CAN RECITE IT BACK TO YOU. [00:31:54.17] I UNDERSTAND WHAT THIS MIGHT NOT [00:31:55.23] HELP ME, I UNDERSTAND THAT YOU [00:31:56.70] DON'T KNOW IF IT'S GOING TO [00:31:58.27] WORK, BUT I'M GOING TO BE THE [00:31:59.83] ONE. [00:32:00.13] IT'S GOING TO HAPPEN, I'M GOING [00:32:01.77] TO BE THE ONE. [00:32:02.97] AND THAT IS NOT ALWAYS A [00:32:08.60] MISUNDERSTANDING IN THE SAME [00:32:09.27] WAY. [00:32:09.43] IT'S IMPORTANT TO THINK ABOUT [00:32:11.10] THIS DISTINCTION BETWEEN [00:32:12.07] KNOWLEDGE AND APPRECIATION. [00:32:14.20] SO PAUL APPLEBALM IS THE PERSON [00:32:17.67] THAT COINED THE TERM THERAPEUTIC [00:32:20.37] MISCONCEPTION, HE'S A [00:32:21.40] PSYCHIATRIST, HE WAS DOING A [00:32:25.00] RANDOMIZED PLACEBO CONTROLLED [00:32:26.43] STUDY WITH PEOPLE WHO HAD [00:32:28.60] SCHIZOPHRENIA AND THEY WERE [00:32:29.43] WORRIED ABOUT UNDERSTANDING AND [00:32:31.00] SO HE WAS PART OF A GROUP THAT [00:32:32.33] WAS INTERVIEWING THEM AFTER THEY [00:32:34.07] WERE GIVEN INFORMATION TO SEE [00:32:35.57] WHAT THEY UNDERSTOOD. [00:32:36.87] HERE IS WHAT HE FOUND IN A SORT [00:32:39.70] OF SIMPLIFIED NUTSHELL, THAT A [00:32:42.00] LOT OF THE PEOPLE THAT HE [00:32:43.63] INTERVIEWED COULD SAY THIS IS A [00:32:46.70] RANDOMIZED PLACEBO CONTROLLED [00:32:47.90] STUDY, THAT MEANS 50% OF THE [00:32:49.03] PEOPLE ARE GOING TO GET PLACEBO, [00:32:50.67] AND YOU'RE TRYING TO FIGURE OUT [00:32:52.03] IF THIS DRUG IS GOING TO WORK [00:32:53.17] SHES THEY UNDERSTOOD THOSE, THEY [00:32:56.40] UNDERSTOOD THOSE FACT, THEY HAD [00:32:57.20] THE KNOWLEDGE, THEN IF HE ASKED, [00:32:58.97] WELL, WHAT ARE YOU GOING TO GET? [00:33:00.33] MOST OF THEM SAID, WELL, MY [00:33:01.80] DOCTOR IS GOING TO GIVE ME [00:33:03.07] WHAT'S BEST FOR ME. [00:33:04.10] SO THEY COULDN'T -- THE FACTS [00:33:05.63] THAT THEY COULD RECITE DIDN'T [00:33:07.67] APPLY TO THEM. [00:33:09.20] AND LOTS OF INTERESTING STUDIES [00:33:10.53] HAVE BEEN DONE THAT HAVE SHOWN [00:33:13.07] THIS DISCONNECT BETWEEN WHAT [00:33:14.30] PEOPLE KNOW AND WHAT THEY THINK [00:33:15.90] APPLIES TO THEM. [00:33:18.97] SO I'VE ALREADY SAID THAT, SO [00:33:20.30] I'LL SKIP. [00:33:21.20] SO THERE'S BEEN A BUNCH OF, LOTS [00:33:24.27] OF STUDIES IN INFORMED CONSENT [00:33:26.40] TO TRY TO SHOW IMPROVEMENTS IN [00:33:29.20] UNDERSTANDING. [00:33:29.60] NOW, THIS WAS A SYSTEMATIC [00:33:30.87] REVIEW THAT WAS PUBLISHED IN [00:33:34.27] 2004 THAT BROKE THE STUDIES THAT [00:33:36.90] BROKE UP STUDIES THAT HAD BEEN [00:33:39.37] DONE UP TO THAT POINT, INTO FOUR [00:33:42.97] CATEGORIES, MULTIMEDIA, ENHANCED [00:33:44.53] CONSENT FORM, EXTENDED [00:33:46.23] DISCUSSION, TEST AND FEEDBACK, [00:33:47.13] IF YOU HAD TO GUESS WHICH ONE [00:33:48.50] WOULD YOU SAY PROBABLY WORKED [00:33:49.50] THE BEST? [00:33:51.57] SOMEBODY SAID SOMETHING? [00:33:55.77] TEST/FEEDBACK? [00:33:56.13] THAT'S ONE OF THE BEST ONES. [00:33:59.83] MULTIMEDIA? [00:34:01.90] NO. [00:34:02.57] ENHANCED? [00:34:03.50] NO. [00:34:04.30] EXTENDED DISCUSSION. [00:34:06.33] EXTENDED DISCUSSION HAD ALMOST [00:34:07.73] THE BEST. [00:34:08.60] THE MORE YOU TALK TO PEOPLE [00:34:09.60] ABOUT THE STUDY, THE BETTER THEY [00:34:12.57] UNDERSTAND. [00:34:14.60] TEST/FEEDBACK ALSO CAME BACK [00:34:15.50] VERY POSITIVE IN THIS ANALYSIS, [00:34:17.07] BUT THERE WERE VERY FEW STUDIES, [00:34:18.33] AND SOME PEOPLE HAVE WORRIED [00:34:19.83] ABOUT, IF YOU GIVE THEM [00:34:22.33] INFORMATION, THEN GIVE THEM A [00:34:23.60] TEST, THEY DON'T DO WELL, YOU [00:34:24.73] TALK TO THEM SOME MORE, THEN YOU [00:34:26.20] GIVE THEM THE SAME TEST, WHETHER [00:34:28.03] YOU'RE REALLY INCREASING [00:34:29.00] UNDERSTANDING OR YOU'RE TEACHING [00:34:29.80] THEM HOW TO TAKE THE TEST. [00:34:32.20] SO THOSE KIND OF STUDIES NEED TO [00:34:34.57] BE, MORE OF THOSE NEED TO BE [00:34:36.33] DONE. [00:34:36.53] SO THOSE ARE THE DATA. [00:34:38.57] SO THERE WAS ANOTHER REVIEW IN [00:34:41.83] 2013 WHICH TRIED TO USE THE SAME [00:34:44.00] CATEGORIES BUT ADDED A FIFTH, [00:34:46.17] THIS MIXED AND MISCELLANEOUS, [00:34:49.23] AND BASICALLY TO SEE IF STUDIES [00:34:51.27] HAD BEEN DONE SINCE THE FIRST [00:34:52.77] REVIEW SHOWED ANY DIFFERENCE. [00:34:54.17] AND THEY BASICALLY CAME OUT WITH [00:34:56.63] THE SAME RESULTS, AND I SHOULD [00:34:58.00] HAVE SHOWN YOU MORE OF THE [00:34:59.37] RESULTS. [00:34:59.67] SO MULTIMEDIA IS VERY MIXED. [00:35:02.87] SOME STUDIES SEEM TO HELP PEOPLE [00:35:06.90] UNDERSTAND AND SOME DON'T, BUT [00:35:08.43] THERE'S NO CONSISTENT [00:35:09.50] IMPROVEMENT IN UNDERSTANDING [00:35:10.23] WITH MULTIMEDIA STUDIES. [00:35:12.03] THEY FOUND SOME INTERESTING [00:35:13.03] STUFF WITH ENHANCED CONSENT FORM [00:35:15.47] ALSO FOUND EXTENDED DISCUSSION [00:35:18.37] IN TEST/FEEDBACK SHOW [00:35:21.47] IMPROVEMENT IN UNDERSTANDING. [00:35:23.17] ONE OF THEIR RESULTS WAS THEY [00:35:25.20] DID A META-ANALYSIS OF A SUBSET [00:35:27.90] OF THE STUDIES THAT HAD BEEN [00:35:28.90] DONE AND SAID THAT THERE'S SOME [00:35:31.80] INCREASED UNDERSTANDING IN THIS [00:35:33.23] ENHANCED CONSENT FORM AND THEY [00:35:35.07] SUGGESTED THAT WHETHER SHORTER [00:35:36.67] FORMS ARE BETTER OR NOT BETTER [00:35:39.20] THAN LONGER ONES IS STILL AN [00:35:43.10] OPEN QUESTION, NEED A RANDOMIZED [00:35:45.43] STUDY, SO SOME OF MY COLLEAGUES [00:35:47.23] AND I HAVE DONE A SERIES OF [00:35:50.00] RANDOMIZED STUDIES OF CONSENT [00:35:51.77] FORMS WHERE WE'VE TAKEN [00:35:53.27] DIFFERENT CO-HORTSZ OF PEOPLE [00:35:54.10] WHO ARE PARTICIPATING IN STUDIES [00:35:55.93] AND RANDOMIZING THEM TO THE [00:35:57.30] STANDARD CONSENT FORM WRITTEN BY [00:35:58.40] THE TEAM OR ONE THAT WAS [00:36:00.33] MODIFIED TO BE SHORTER AND OF A [00:36:01.83] LOWER READING LEVEL AND SEE WHAT [00:36:04.03] THE DIFFERENCE WAS. [00:36:05.70] AND IN TWO COHORTS OF HEALTHY [00:36:09.27] VOLUNTEERS, AND NOW ONE LARGE [00:36:12.43] MULTINATIONAL HIV STUDY OF MORE [00:36:15.37] THAN 4,000 PERSONS IN THIS [00:36:16.63] STUDY, WHAT WE FOUND, NO [00:36:19.13] DIFFERENCE. [00:36:19.50] AND THIS IS NO DIFFERENCE IN [00:36:21.57] UNDERSTANDING BETWEEN PERSONS [00:36:22.67] WHO RECEIVED A 15-PAGE CONSENT [00:36:25.10] FORM AND PERSONS WHO RECEIVED A [00:36:27.20] 4-PAGE CONSENT FORM. [00:36:32.80] SO WHAT DO WE KNOW ABOUT [00:36:34.90] UNDERSTANDING? [00:36:35.27] MORE IS NOT ALWAYS BETTER, BUT [00:36:36.77] IT'S NOT NECESSARILY WORSE. [00:36:39.30] TIMING DOES MATTER, AND [00:36:40.67] TECHNOLOGY CAN HELP AND YOU'LL [00:36:42.00] HEAR MORE ABOUT THAT LATER. [00:36:43.87] WHAT ABOUT VOLUNTARINESS? [00:36:46.30] VOLUNTARINESS IS AN INTERESTING [00:36:48.87] CONCEPT. [00:36:49.10] THE WAY WE DESCRIBE IT IN THE [00:36:50.53] PROCESS OF INFORMED CON SENT IS [00:36:51.87] THE ABILITY TO MAKE A VOLUNTARY [00:36:57.47] CHOICE. [00:36:57.70] SO SORT OF INTERESTING TO THINK [00:36:58.80] ABOUT WHAT A VOLUNTARY CHOICE IS [00:37:00.60] BECAUSE IT SEEMS LIKE ALL [00:37:03.53] CHOICES ARE -- ALL CHOICES THAT [00:37:08.07] WE MAKE ARE INFLUENCED TO SOME [00:37:09.87] EXTENT BY OUR BACKGROUNDS, OUR [00:37:11.50] EXPERIENCES, OUR TRAINING, THE [00:37:13.03] CONTEXT, I MEAN, SO MANY THINGS, [00:37:14.50] AND YET WE STILL THINK WE MAKE [00:37:16.80] VOLUNTARY CHOICES. [00:37:17.40] SO BEING ABLE TO JUDGE WHETHER [00:37:20.13] SOMEONE ELSE IS MAKING A [00:37:21.77] VOLUNTARY CHOICE IS TRICKY. [00:37:24.93] ONE OF THE WAYS THAT I THE [00:37:26.53] REGULATIONS SEEM TO COME DOWN ON [00:37:27.93] THIS ISSUE OF VOLUNTARY CHOICE [00:37:29.80] IS BY SAYING THAT PEOPLE SHOULD [00:37:31.17] NOT BE SUBJECTED TO DECEPTION [00:37:34.57] EXCEPT UNDER CERTAIN [00:37:35.90] CIRCUMSTANCES, COERCION, OR [00:37:38.80] UNDUE INFLUENCE. [00:37:39.40] AND I LOVE THIS CARTOON. [00:37:41.53] IT'S NOT FUNNY, BUT IT TELLS THE [00:37:45.60] STORY OF HOW -- IT DOESN'T LOOK [00:37:48.37] TOO VOLUNTARY TO ME. [00:37:49.83] WHAT ARE THE THINGS THAT AFFECT [00:37:51.30] A PERSON'S ABILITY TO MAKE [00:37:53.13] VOLUNTARY DECISIONS? [00:37:54.07] WELL, SOME ARE CLEARLY [00:37:57.03] PROBLEMATIC. [00:37:57.53] SO IN PERSONS IN DEPENDENT [00:37:59.67] POSITIONS WHO ARE DEPENDING ON [00:38:00.90] THE PERSON WHO IS ASKING THEM TO [00:38:02.37] MAKE A CHOICE, SOMETIMES HAVE [00:38:04.17] DIFFICULTY SAYING NO, RIGHT? [00:38:06.73] POWER RELATIONS, THE SAME IDEA, [00:38:08.40] PRESSURE FROM FAMILY, FROM [00:38:10.03] FRIENDS, FROM PROVIDERS, TRUST [00:38:15.40] MAYBE. [00:38:15.60] LESS CLEAR ARE THINGS LIKE [00:38:17.23] RESTRICTED CHOICES AND ILLNESSES [00:38:18.23] AND INCENTIVE. [00:38:18.90] A LOT OF PEOPLE WORRY ABOUT [00:38:20.13] THESE THINGS AS INFLUENCING [00:38:21.23] ABILITY TO MAKE VOLUNTARY [00:38:23.53] CHOICES, BUT I THINK THERE'S [00:38:25.27] PLENTY OF REASON TO THINK THAT [00:38:26.47] THAT'S NOT SO STRAIGHTFORWARD. [00:38:28.07] LET ME JUST GIVE YOU AN EXAMPLE [00:38:31.77] ON RESTRICTDZ CHOICES. [00:38:34.20] SOMEONE HAS BREAST CANCER AND [00:38:35.43] THE DOCTOR SAYS TO THEM, YOU [00:38:38.37] KNOW, YOU HAVE TWO CHOICES, [00:38:40.40] RADIATION -- SORRY, SURGERY OR [00:38:43.93] CHEMOTHERAPY OR NO TREATMENT. [00:38:47.80] OKAY, THOSE ARE PRETTY [00:38:49.57] RESTRICTED CHOICES, RIGHT? [00:38:50.53] BUT THE PERSON CAN STILL MAKE A [00:38:52.43] CHOICE BETWEEN THOSE CHOICES. [00:38:56.80] SO THESE ARE INTERESTING THINGS [00:38:58.03] TO THINK ABOUT. [00:38:58.97] SO WHAT ABOUT DATA? [00:39:00.43] THERE'S NOT A LOT OF DATA THAT'S [00:39:02.83] VERY CLEARLY MEASURING [00:39:04.70] VOLUNTARINESS, BUT HERE ARE SOME [00:39:05.73] THINGS THAT DO. [00:39:06.50] SO THERE ARE SOME STUDIES THAT [00:39:08.17] HAVE LOOKED AT PRESSURE, ASK [00:39:09.60] PEOPLE HOW MUCH PRESSURE HAVE [00:39:10.27] YOU PERCEIVED? [00:39:11.00] WHEN YOU ASK FOR PRESSURE FROM [00:39:14.03] OTHERS, THE NUMBERS ARE PRETTY [00:39:15.67] SMALL. [00:39:15.87] THEY'RE USUALLY IN THE 2 TO 5% [00:39:17.63] RANGE BUT THEY GO UP TO AS MUCH [00:39:19.43] AS 25%, AND IT'S LIKE THE [00:39:22.77] VOLUNTARY DATA THAT I SHOWED YOU [00:39:23.87] BEFORE FROM THE META-ANALYSIS, [00:39:25.40] THAT MAY BE TOO HIGH. [00:39:26.83] IT MAY BE TOO HIGH TO SAY 25% OF [00:39:30.93] PEOPLE FELT PRESSURE FROM [00:39:31.80] SOMEBODY ELSE TO JOIN THE STUDY. [00:39:33.00] WHEN YOU ASK PEOPLE ABOUT [00:39:34.07] PRESSURE FROM OTHER THINGS, LIKE [00:39:37.20] IN THIS CASE THIS WAS A VACCINE [00:39:41.30] TRIAL, THE PRESSURE IS HIGHER, [00:39:43.77] THE PARENTS FELT GREAT PRESSURE [00:39:45.17] FROM THE FACT THAT THEIR [00:39:46.83] CHILDREN WERE SEVERELY ILL. [00:39:47.97] THERE ARE PEOPLE WHO DESCRIBE [00:39:49.13] FEELING PRESSURE THERE THEIR [00:39:50.53] FINANCIAL CIRCUMSTANCES AS WELL. [00:39:51.67] THERE'S ALSO DATA ON PEOPLE WHO [00:39:54.47] KNOW -- WHETHER PEOPLE KNOW THEY [00:39:55.33] CAN QUIT OR NOT. [00:39:56.80] AND AGAIN, IT RANGES. [00:40:00.03] PRETTY SMALL HERE, BUT UP TO 90% [00:40:02.33] IN OTHER STUDIES. [00:40:03.90] THERE'S ALSO DATA ON PEOPLE WHO [00:40:05.27] REFUSE TO PARTICIPATE, AND THAT [00:40:06.90] IS AN INDICATION THAT THEY ARE [00:40:08.63] PROBABLY MAKING A VOLUNTARY [00:40:10.73] CHOICE, RIGHT? [00:40:14.23] SO THERE ARE LIMITED DATA, IT'S [00:40:17.13] DIFFICULT TO AMERICA NOT TOO [00:40:18.67] MANY FEEL PRESSURE FROM OTHERS, [00:40:20.03] BUT MANY, SOME SAY TOO MANY, SAY [00:40:23.27] THEY CAN'T QUIT OR COULDN'T SAY [00:40:25.17] NO, AND THE VARIABLE RATES. [00:40:27.77] DAVE WINDLER PUBLISHED A PAPER A [00:40:31.70] COUPLE YEARS AGO WHICH I FOUND [00:40:33.17] HELPFUL IN THINKING ABOUT HOW [00:40:34.33] THESE DIFFERENT FACTORS MATTER [00:40:36.40] DEPENDING ON THE STUDY ITSELF. [00:40:40.10] SO IF YOU LOOK AT THIS CHART FOR [00:40:41.60] A SECOND, HE HAS ACROSS THE TOP [00:40:44.63] LOW RISK STUDIES, MODERATE RISK, [00:40:47.47] OR POTENTIAL BENEFIT STUDIES AND [00:40:50.53] HIGH RISK, LITTLE OR NO [00:40:52.13] POTENTIAL BENEFIT, AND SUGGESTS [00:40:53.30] THAT BOTH IN TERMS OF [00:41:00.10] COMPETENCE, UNDERSTANDING AND [00:41:02.13] VOLUNTARINESS, IT'S SORT OF LIKE [00:41:03.27] A SPECTRUM, THAT AT THE LOW [00:41:05.50] LEVEL, LOW RISK, YOU CAN ASSUME [00:41:07.13] COMPETENCE, YOU CAN ASSUME [00:41:08.20] UNDERSTANDING, AND YOU CAN [00:41:09.87] ASSUME VOLUNTARINESS WITHOUT A [00:41:11.27] LOT OF SCRUTINY, BUT AS THE [00:41:13.80] RISKS GET HIGHER, THAT THE ONUS [00:41:16.23] IS ON US TO DO MORE FORMAL [00:41:19.97] ASSESSMENT OF THESE COMPONENTS [00:41:21.70] OF THE CONSENT PROCESS. [00:41:25.77] SO MY CONCLUSIONS IN GENERAL ARE [00:41:28.53] INFORMED CONSENT, ETHICALLY [00:41:31.40] IMPORTANT BUT IMPERFECTLY [00:41:33.13] REALIZED, THE DATA SUGGESTS [00:41:34.43] CONSENT FORMS ARE LONG AND [00:41:35.67] COMPLEX, UNDERSTANDING IS [00:41:36.80] VARIABLE, ESPECIALLY IN CERTAIN [00:41:38.03] AREAS IT'S LOW, MANY [00:41:40.87] PARTICIPANTS DON'T KNOW THEY CAN [00:41:42.00] QUIT, SPENDING MORE TIME WITH [00:41:43.83] PEOPLE EXPLAINING THINGS COULD [00:41:46.57] ENHANCE UNDERSTANDING AND WE [00:41:47.53] NEED MORE DATA ABOUT HOW TO [00:41:50.60] IMPROVE UNDERSTANDING AND [00:41:51.80] IMPROVE THE PROCESS IN A VARIETY [00:41:53.77] OF SETTINGS AND IMPROVE PEOPLE'S [00:41:56.37] EXPERIENCE. [00:41:56.67] I WANT TO END WITH JUST A COUPLE [00:41:58.63] OF EXAMPLES OF THINGS THAT ARE [00:42:02.30] CONTEMPORARY CHALLENGES, THINGS [00:42:03.90] THAT ARE BEING DISCUSSED RIGHT [00:42:05.27] NOW. [00:42:05.47] ONE IS THE ISSUE OF CONSENT FOR [00:42:10.20] BIOSPECIMENS AND FOR RESEARCH [00:42:11.47] WITH BIOSPECIMENS AND DATA, AND [00:42:13.90] YOU'RE GOING TO HAVE BOTH A TALK [00:42:15.93] TODAY ON BIG DATA AND A TALK [00:42:18.00] NEXT WEEK, MAYBE, OR THE WEEK [00:42:20.07] AFTER ON RESEARCH WITH [00:42:21.43] SPECIMENS. [00:42:21.70] SO SOME OF THIS WILL COME UP. [00:42:24.80] BUT I THINK IT'S INTERESTING TO [00:42:25.97] THINK ABOUT THE FACT THAT THE [00:42:27.90] DEBATE IS TO A LARGE EXTENT [00:42:30.23] ABOUT CONSENT. [00:42:30.80] WHAT IS THE RIGHT KIND OF [00:42:32.67] CONSENT? [00:42:32.90] SHOULD THERE BE CONSENT IS ONE [00:42:34.43] PART OF THE DISCUSSION. [00:42:35.40] BUT THEN IF THERE SHOULD BE, [00:42:37.03] WHAT SHOULD IT LOOK LIKE? [00:42:40.47] WHAT INFORMATION SHOULD BE [00:42:41.70] DISCLOSED? [00:42:41.97] WHAT LEVEL OF UNDERSTANDING [00:42:43.10] SHOULD PEOPLE HAVE? [00:42:44.47] HOW MUCH VOLUNTARY CHOICE SHOULD [00:42:47.10] THEY HAVE? [00:42:47.87] AND THERE'S A SPECTRUM OF TYPES [00:42:50.17] OR METHODS OF CONSENT THAT [00:42:51.60] PEOPLE ARE DEBATING, AND YOU'RE [00:42:53.40] GOING TO HEAR MORE ABOUT THAT. [00:42:56.57] THERE'S ALSO A SORT OF [00:42:59.13] CONTEMPORARY DEBATE ABOUT WHAT [00:43:01.17] THE ROLE OF CONSENT IS IN [00:43:04.33] PRAGMATIC TRIALS OR COMPARATIVE [00:43:06.90] EFFECTIVENESS TRIALS OR RESEARCH [00:43:08.00] ON MEDICAL PRACTICE, AND YOU'RE [00:43:09.10] ALSO GOING TO HAVE A LECTURE ON [00:43:10.67] THIS, AND SCOTT IS GOING TO GIVE [00:43:12.17] ONE I THINK IN TWO WEEKS ON [00:43:14.17] PRAGMATIC TRIALS. [00:43:14.93] BUTTER AGAIN, A LOT OF THE [00:43:16.53] DEBATE ABOUT THIS IS WHAT KIND [00:43:18.20] OF CONSENT SHOULD WE BE USING IN [00:43:20.87] THE CONTEXT OF THINGS THAT [00:43:23.83] PEOPLE FEEL LIKE ARE JUST LIKE [00:43:26.13] REGULAR MEDICAL PRACTICE? [00:43:28.00] AND I'M GOING ON SKIP THOSE. [00:43:30.27] THE LAST ONE IS THE ONE ABOUT [00:43:33.53] BIG DATA, AND I THINK IT'S [00:43:35.30] REALLY INTERESTING BECAUSE A LOT [00:43:36.53] OF THE DATA, AS YOU PROBABLY [00:43:38.97] KNOW, IS PASSIVELY COLLECTED. [00:43:43.27] SO EVEN IF PEOPLE ARE INFORMED [00:43:45.47] AT SOME LEVEL, NOT EVERYBODY [00:43:47.97] READS THE NOTIFICATION NOTICES [00:43:49.43] OR WHATEVER THEY ARE, SO THIS IS [00:43:53.37] AN INTERESTING QUESTION ABOUT IS [00:43:56.37] THIS SOMETHING THAT WE SHOULD [00:43:57.53] DISCUSS IN TERMS OF HOW CONSENT [00:43:59.73] OUGHT TO BE OBTAINED FOR BIG [00:44:04.10] DATA? [00:44:04.33] SO TO END, AS RESEARCH AND [00:44:08.17] TECHNOLOGY EVOLVE, I THINK IT'S [00:44:09.63] HELPFUL TO MAINTAIN CLARITY [00:44:11.17] ABOUT WHAT THE PURPOSE OF [00:44:12.67] CONSENT IS, AND THAT WILL HELP [00:44:14.40] US DECIDE WHAT'S APPROPRIATE IN [00:44:16.73] CERTAIN CONTEXTS AND WHAT KIND [00:44:18.00] OF METHODS TO USE. [00:44:20.23] WE NEED TRAINING OF PEOPLE TO [00:44:21.60] MAKE SURE THAT WE DO OUR BEST AT [00:44:25.30] CHOOSING THE INFORMATION TO [00:44:27.70] DISCLOSE, DISCLOSING IT IN A WAY [00:44:29.30] THAT'S ACCESSIBLE TO THE PEOPLE [00:44:31.33] THAT WE'RE GIVING IT TO, AND [00:44:32.93] THEN MAKING SURE THAT THEY HAVE [00:44:34.37] AN OPPORTUNITY TO UNDERSTAND IT, [00:44:37.70] AND I THINK WE NEED SOME [00:44:39.07] CREATIVITY AND EVIDENCE IN THAT. [00:44:41.23] OKAY. [00:44:41.43] THAT'S IT. [00:44:42.00] QUESTIONS? [00:44:43.50] COMMENTS? [00:44:51.77] >> SO YOU WERE TALKING ABOUT [00:44:53.87] RESTRICTED CHOICES. [00:44:55.10] SO I DO BONE MARROW TRANSPLANT, [00:44:57.03] AND WE OFTEN HAVE SITUATIONS [00:44:58.53] WHERE PATIENTS HAVE A DISEASE [00:45:00.47] THAT'S INCURABLE AND [00:45:03.03] LIFE-THREATENING WITHOUT A BONE [00:45:04.07] MARROW TRANSPLANT BUT HAVE NO [00:45:05.37] ACCESS TO A BONE MARROW [00:45:07.83] TRANSPLANT OUTSIDE OF A CLINICAL [00:45:09.53] STUDY AT THE NIH, AND IN THOSE [00:45:11.27] SITUATIONS, I MEAN, THEY'RE [00:45:12.47] REALLY CHOOSING POTENTIAL LIFE [00:45:15.33] VERSUS DEATH, NOT REALLY [00:45:16.37] ANYTHING ABOUT THE RESEARCH. [00:45:17.80] AND I'M JUST WONDERING -- AND [00:45:21.03] OFTEN THE RESEARCH MAY -- I [00:45:22.33] MEAN, WE DON'T EXPECT TO [00:45:23.30] INFLUENTIAL THEIR POTENTIAL FOR [00:45:25.03] BENEFIT, WHICH IS VERY HIGH IN [00:45:26.73] THOSE STUDIES, BUT OF COURSE A [00:45:28.97] BONE MARROW TRANSPLANT IN [00:45:31.73] GENERAL EVEN STANDARD PRACTICE [00:45:32.50] IS A RISKY PROCEDURE. [00:45:34.03] SO I DON'T KNOW WHAT YOUR [00:45:35.40] THAWTLE ARE -- THOUGHTS ARE [00:45:37.17] ABOUT THOSE PARTICULAR [00:45:38.80] SITUATIONS. [00:45:39.40] >> Christine Grady: WELL, I FIND [00:45:40.10] THOSE SITUATIONS VERY [00:45:42.37] COMPLICATED, I THINK, AND IT [00:45:43.43] SOUNDS LIKE YOU DO TOO. [00:45:45.80] I THINK THERE'S ONE WAY TO ARGUE [00:45:50.57] WITH THAT WE ARE OFFERING [00:45:52.37] SOMEBODY A CHOICE THAT THEY [00:45:53.60] OTHERWISE DON'T HAVE, RIGHT, [00:45:56.17] RATHER THAN COERCING THEM OR [00:45:58.17] PRESSURING THEM INTO SOMETHING [00:45:59.53] THAT THEY DON'T WANT TO DO. [00:46:01.10] THAT'S ONE WAY TO SORT OF VIEW [00:46:02.50] IT. [00:46:02.83] BUT IT IS TRUE, AS YOU SAID, YOU [00:46:05.20] KNOW, PEOPLE WHO CANNOT ACCESS A [00:46:07.07] CERTAIN PROCEDURE, AND BONE [00:46:08.27] MARROW IS A GREAT EXAMPLE, ON [00:46:12.40] THE OWRSD IN THE REGULAR [00:46:14.17] CLINICAL CARE WORLD -- ON THE [00:46:15.37] OUTSIDE IN THE REGULAR CLINICAL [00:46:16.63] CARE WORLD ARE GOING TO LOOK [00:46:18.40] FOR, AND WANT IT, ARE GOING TO [00:46:19.83] LOOK FOR OPPORTUNITIES THAT ARE [00:46:21.00] RESEARCH OPPORTUNITIES AND THE [00:46:21.63] QUESTION IS WHETHER THE RESEARCH [00:46:23.47] POSES RISKS THAT THEY OTHERWISE [00:46:25.87] WOULDN'T WANT, AND IT MIGHT, [00:46:27.83] RIGHT? [00:46:28.17] SO I THINK THEN THE ONUS ON US [00:46:29.90] IS TO MAKE SURE THAT THOSE [00:46:32.30] DIFFERENCES ARE AS CLEAR AS [00:46:34.80] POSSIBLE, THAT OTHER OPTIONS FOR [00:46:36.37] OBTAINING A TRANSPLANT ARE AT [00:46:39.97] LEAST HAVE BEEN LOOKED FOR AND [00:46:41.80] EXHAUSTED MAYBE EVEN, SO THAT [00:46:45.23] THE PERSON'S LACK OF CHOICE DOES [00:46:47.13] NOT BECOME THE ONLY REASON THAT [00:46:49.00] THEY'RE CHOOSING THE BONE MARROW [00:46:52.70] TRANSPLANT STUDY THAT YOU'RE [00:46:53.47] OFFERING THEM. [00:46:54.07] DOES THAT MAKE SENSE? [00:46:56.73] >> WHY YOU. [00:46:57.70] >> Christine Grady: BUT THOSE [00:46:58.33] ARE HARD CASES, AND I THINK [00:47:01.27] MAYBE YOU HAVE PATIENTS LIKE [00:47:03.80] THIS TOO. [00:47:12.53] , I THINK IT GETS HARDER WHEN [00:47:14.10] PEOPLE COME FROM OTHER PARTS OF [00:47:15.33] THE WORLD WHERE ACCESS TO CARE [00:47:16.63] AND PROCEDURES IS BASICALLY [00:47:18.50] NONEXISTENT. [00:47:19.13] >> THE STUDY, THE STUDIES OF [00:47:24.23] SHORT VERSUS LONG, WERE THEY AT [00:47:26.13] A 6TH GRADE LEVEL THE READING? [00:47:28.37] CHRIS CHRIS GREAT QUESTION. [00:47:29.27] THAT WAS OUR GOAL. [00:47:32.30] >> Christine Grady: GREAT [00:47:32.87] QUESTION. [00:47:33.13] THAT WAS OUR GOAL. [00:47:33.80] IT'S ACTUALLY INTERESTING. [00:47:34.47] WE WERE NOT ABLE TO GET THINGS [00:47:36.40] TO 6TH GRADE LEVEL AND PART OF [00:47:42.53] THE REASON WE COULD NOT WAS [00:47:43.60] BECAUSE OF WHAT THE IRB'S [00:47:45.47] REQUIRED US TO PUT IN AND THE [00:47:48.63] REGULATORS. [00:47:49.13] IDEALLY WE WOULD HAVE GOTTEN [00:47:50.07] THEM SHORTER AND SIMPLER THAN WE [00:47:52.33] DID, BUT, YEAH, I THINK THE BEST [00:47:54.30] WE WERE ABLE TO GET WAS 8TH [00:47:56.13] GRADE. [00:47:56.37] >> HAVE THERE BEEN STUDIES ON [00:47:58.73] THE GRADE LEVEL OF THE READINGS? [00:48:01.90] >> Christine Grady: AND [00:48:02.40] UNDERSTANDING? [00:48:02.77] >> UNDERSTANDING, YES. [00:48:04.37] >> Christine Grady: YEAH, I [00:48:05.60] MEAN, CERTAINLY THERE'S -- IN [00:48:08.20] THE RESEARCH CONTEXT, THERE HAVE [00:48:09.50] BEEN OTHER STUDIES THAT HAVE [00:48:11.37] LOOKED AT SHORT AND LONG, [00:48:12.87] SIMPLER AND MORE COMPLICATED [00:48:15.77] FORMS, AND THE RESULT IS THAT [00:48:20.10] META-ANALYSIS SHOWED ARE NOT A [00:48:21.63] SLAM-DUNK IN EITHER WAY. [00:48:22.67] SOME STUDIES SHOW AN IMPROVEMENT [00:48:24.13] IN UNDERSTANDING, AND SOME DON'T [00:48:25.57] SHOW ANY IMPROVEMENT IN [00:48:26.67] UNDERSTANDING. [00:48:27.03] I MEAN, THE SORT OF INTUITION I [00:48:28.33] THINK THAT AWFUL US HAVE IS THAT [00:48:31.83] IF -- I THINK THAT ALL OF US [00:48:33.30] HAVE IS THAT FITS A LESS [00:48:35.43] COMPLICATED, MORE READABLE FORM, [00:48:36.60] IT WOULD BE EASIER TO [00:48:37.63] UNDERSTAND. [00:48:38.17] WE CERTAINLY HAVE DATA FROM [00:48:40.40] NONRESEARCH CONTEXT WHERE THAT'S [00:48:41.40] TRUE, RIGHT? [00:48:41.93] BUT I THINK IN THE CONTEXT OF [00:48:46.03] RESEARCH MY OWN VIEW AT THE [00:48:47.07] MOMENT IS THAT THERE'S SO MUCH [00:48:48.27] ELSE GOING ON IN TERMS OF [00:48:49.47] EXPECTATIONS THAT PEOPLE BRING [00:48:50.23] WITH THEM TO THE ENCOUNTER TO [00:48:54.23] BEGIN WITH, INFORMATION THAT [00:48:57.10] THEY GET FROM OTHER SOURCES, [00:48:58.37] THAT THE WRITTEN WORDS IN THE [00:48:59.50] CONSENT FORM ARE PROBABLY REALLY [00:49:01.10] LESS IMPORTANT THAN WE SOMETIMES [00:49:03.90] THINK THEY ARE. [00:49:06.70] >> THANK YOU ARE. [00:49:08.83] >> HI,. [00:49:12.27] >> Christine Grady: SEEN. [00:49:12.83] WHEN ARE YOU ALLOWED TO REPLACE [00:49:14.83] WITH THE SHORT FORM AND THE [00:49:17.10] INFORMATION IF IT'S SUFFICIENT [00:49:18.03] FOR THE PART ANT IN THE SHORT [00:49:19.57] FORM DOES IT COVER EVERY PART OF [00:49:23.97] THE -- [00:49:24.20] >> Christine Grady: WHICH SHORT [00:49:24.87] FORM ARE YOU ASKING ABOUT? [00:49:25.60] >> THE SUMMARY. [00:49:26.93] THE SUMMARY OF THE INFORMED [00:49:28.33] CONSENT FORM, SO YOU GET THE [00:49:30.63] SHORT FORM THAT HAS THE SUMMARY [00:49:32.67] OF ALL THE INFORMATION OR [00:49:35.80] LIMITED INFORMATION. [00:49:40.13] >> Christine Grady: THAT'S A [00:49:40.73] REALLY IMPORTANT QUESTION AND [00:49:41.47] IT'S IMPORTANT TO BE CLEAR ABOUT [00:49:42.53] WHAT A SHORT FORM IS. [00:49:44.03] SO IN THE STUDIES THAT I WAS [00:49:47.03] DESCRIBING, WE WERE RANDOMIZING [00:49:49.03] PEOPLE TO TWO DIFFERENT FORMS, [00:49:50.30] ONE WE CALLED THE SHORT OR [00:49:51.77] CONCISE CONSENT FORM, BUT IT WAS [00:49:53.27] A CONSENT FORM THAT INCLUDED ALL [00:49:55.13] OF THE ELEMENTS OF INFORMED [00:49:56.73] CONSENT AS REQUIRED BY THE [00:49:58.87] REGULATIONS, JUST IN SIMPLER [00:50:00.27] LANGUAGE, AND WE USED TABLES AND [00:50:02.57] BULLETS AND GRAPHS AND THINGS [00:50:05.53] LIKE THAT, SO FROM THE [00:50:08.23] PERSPECTIVE OF THIS IS THIS A [00:50:09.43] CONSENT FORM IN THE WAY THAT WE [00:50:11.40] THINK ABOUT CONSENT FORM, IT'S [00:50:13.03] EXACTLY THE SAME. [00:50:13.63] DO YOU SEE WHAT I MEAN? [00:50:14.73] THE REASON WHY I THINK IT'S [00:50:16.10] IMPORTANT TO DISTINGUISH IS AT [00:50:16.77] THE NIH INTRAMURALLY ANYWAY, AND [00:50:19.13] A LOFT PEOPLE HERE ARE [00:50:20.97] INTRAMURAL, WE HAVE AN OPTION [00:50:22.83] FOR ESPECIALLY FOR PEOPLE WHO DO [00:50:24.50] NOT SPEAK ENGLISH, WHO DO NOT [00:50:26.00] READ ENGLISH. [00:50:26.73] WE HAVE A WHOLE -- I THINK THERE [00:50:30.63] ARE 17 LANGUAGES OF WHAT WE CALL [00:50:33.73] SHORT FORMS AND THE POLICY IS [00:50:35.87] SET UP SO THAT IF SOMEBODY [00:50:38.07] DOESN'T SPEAK ENGLISH AND THERE [00:50:38.97] IS NOT A CONSENT FORM IN THEIR [00:50:41.73] LANGUAGE, THEN THE CONSENT [00:50:44.37] PROCESS IS ORAL AND THE SHORT [00:50:46.40] FORM IS USED JUST TO GET THEIR [00:50:48.97] SIGNATURE, AND THE SHORT FORM [00:50:50.17] ONLY HAS ON IT INFORMATION LIKE [00:50:54.27] THIS IS VOLUNTARY, YOU KNOW, [00:50:56.47] SOME OF THE STANDARD NONCONTEXT [00:50:59.50] SPECIFIC LANGUAGE ABOUT THE [00:51:00.80] STUDY BUT STANDARD LANGUAGE THAT [00:51:02.07] EVERYBODY GETS. [00:51:03.23] SO THAT'S A SHORT FORM THAT [00:51:04.93] PEOPLE USE HERE. [00:51:07.43] THERE HAVE BEEN OTHER GROUPS [00:51:08.47] THAT HAVE TRIED TO TEST OTHER [00:51:11.57] KINDS OF SHORT FORMDZ, YOU KNOW, [00:51:14.30] SUMMARY INFORMATION THAT SORT OF [00:51:15.73] PUTS LOTS OF APPENDICES IN THE [00:51:17.93] BACK, SO THERE'S SOME [00:51:19.23] INTERESTING STUDIES THAT HAVE [00:51:20.20] BEEN OUT THERE, BUT TO MY [00:51:24.03] KNOWLEDGE, THERE'S NO SORT OF [00:51:27.63] DEFINITIVE PROOF THAT DOING ANY [00:51:29.13] OF THAT MAKES A HUGE DIFFERENCE [00:51:30.40] IN TERMS OF UNDERSTANDING. [00:51:33.73] >> I'M CURIOUS IN ALL OF THE [00:51:35.73] RESEARCH ABOUT UNDERSTANDING, [00:51:37.83] KIND OF HOW THAT INTERACTS WITH [00:51:39.10] THE FACT THAT NOT EVERYBODY [00:51:40.40] CARES ABOUT THE SAME THINGS, SO [00:51:43.10] YOU HAVE THE KIND OF REASONABLE [00:51:44.43] PERSON STANDARD, BUT THAT [00:51:45.97] DOESN'T REALLY ACCOUNT FOR HOW [00:51:46.97] MUCH VARIATION THERE IS BETWEEN [00:51:48.80] PEOPLE. [00:51:49.07] SO CLEARLY WE WANT EVERYBODY TO [00:51:50.33] KNOW THEY CAN WITHDRAW, [00:51:51.73] EVERYBODY NEEDS TO KNOW THAT, [00:51:52.63] BUT IF I DON'T CARE ABOUT A [00:51:53.93] RISK, I MIGHT JUST KIND OF [00:51:56.37] PASSES THAT IN THE FORM EXPNLT [00:51:57.50] CARE. [00:51:57.73] SO I'M CURIOUS IF ANY OF THE [00:52:00.07] RESEARCH HAS KIND OF ASKED HOW [00:52:01.07] MUCH THE PEOPLE WHO AREN'T [00:52:02.50] UNDERSTANDING THESE THINGS CARED [00:52:03.23] ABOUT THEM. [00:52:04.90] >> Christine Grady: YEAH, GREAT [00:52:05.57] QUESTION. [00:52:05.83] THERE HAVE BEEN A FEW STUDIES [00:52:07.30] AND I WON'T EVEN BE ABLE TO CITE [00:52:09.57] THE AUTHORS, BUT I KNOW THERE [00:52:10.87] HAVE BEEN SOME STUDIES THAT HAVE [00:52:14.80] GATHERED GROUPS OF PEOPLE TO [00:52:15.90] LOOK AT INFORMATION AND CONSENT [00:52:17.03] FORMS AND ACTUALLY ASK THEM THAT [00:52:21.97] QUESTION, YOU KNOW, HERE IS WHAT [00:52:23.60] WE PROVIDE, WHAT OF THIS [00:52:24.93] INFORMATION DO YOU REALLY WANT [00:52:25.67] TO KNOW? [00:52:26.03] I THINK LAURA BESKOW HAS DONE A [00:52:29.60] CUSP HE WILL OF THESE STUDIES [00:52:30.83] AND TRY TO TEASE OUT WHAT ARE [00:52:32.20] THE STHINGZ THAT ARE IMPORTANT [00:52:33.13] TO THE PEOPLE WHO ARE TRYING TO [00:52:34.90] DECIDE ABOUT PARTICIPATION AND [00:52:35.67] DO THEY MATCH OR NOT THE KINDS [00:52:38.60] OF ELEMENTS OF INFORMATION THAT [00:52:43.33] THE REGULATIONS REQUIRE AND THAT [00:52:44.80] WE THINK ARE NECESSARY. [00:52:45.83] I WISH I COULD SAY MORE ABOUT [00:52:47.17] THEIR RESULTS, I DON'T KNOW, BUT [00:52:48.33] I COULD GET YOU THE REFERENCE IF [00:52:51.20] YOU WANT. [00:52:53.20] >> THIS IS REGARDING THERAPEUTIC [00:52:58.60] MISCONCEPTION, PATIENTS CRRLSZ [00:52:59.53] THAT ARE SIGHING FOR ALTRUISTIC [00:53:01.67] AND THE BENEFITS OF THE STUDY, [00:53:03.30] BUT THAT THERE'S NO BENEFIT FROM [00:53:04.77] THIS STUDY, WHAT COULD BE DONE [00:53:06.27] TO MINIMIZE THE THERAPEUTIC [00:53:08.53] MISCONCEPTION AND ALSO GIVE [00:53:11.07] CLEAR INFORMATION BASED ABOUT [00:53:14.73] THE EXPERIMENTAL INTERVENTION [00:53:16.00] BASED ON THE SCIENTIFIC FACTS [00:53:17.77] AVAILABLE, LIKE CAN WE ACTUALLY [00:53:19.13] SAY THAT YOU MAY BENEFIT BECAUSE [00:53:22.20] THERE IS EVIDENCE ABOUT THIS [00:53:23.13] DRUG OR NOT? [00:53:26.23] >> Christine Grady: THAT'S AœGOOD QUESTION THAT I'M ALMOST [00:53:31.33] TEMPTED TO DEFER TO THE NEXT [00:53:33.50] SPEAKER WHO HAS DONE A LOT OF [00:53:34.70] WORK ON THERAPEUTIC [00:53:36.57] MISCONCEPTION, I'LL SAY ONE [00:53:37.23] THING AND THEN HE CAN CORRECT [00:53:38.53] ME. [00:53:38.70] I THINK THERE IS SOME [00:53:41.17] OVEREXAGGERATION ABOUT THE [00:53:42.83] THERAPEUTIC MISCONCEPTION, SO TO [00:53:44.53] YOUR FIRST POINT, I THINK THERE [00:53:45.93] ARE PEOPLE WHO PARTICIPATE IN [00:53:47.63] RESEARCH WHO CAN SAY TO YOU IN [00:53:50.23] THE SAME SENTENCE BASICALLY I [00:53:53.00] UNDERSTAND THAT THIS IS [00:53:54.77] RESEARCH, I UNDERSTAND THAT [00:53:55.37] YOU'RE TRYING TO FIND AN ANSWER [00:53:56.70] TO THIS QUESTION, AND I'M [00:53:58.57] PARTICIPATING BECAUSE I HOPE [00:53:59.60] THAT I'M GOING TO BENEFIT. [00:54:02.37] AND I DON'T THINK THAT IS [00:54:03.20] NECESSARILY A THERAPEUTIC [00:54:05.93] MISCONCEPTION. [00:54:06.27] I THINK IT'S A DISTINCTION [00:54:08.57] BETWEEN WHAT THEY UNDERSTAND THE [00:54:11.37] STUDY IS ABOUT AND WHAT THEIR [00:54:13.00] MOTIVATION IS OR THEIR HOPE IS, [00:54:16.97] WHICH ARE NOT NECESSARILY [00:54:19.93] CONFLATING ANYTHING. [00:54:20.90] THEY'RE DIFFERENT. [00:54:24.13] SO ACTUALLY PAYING ATTENTION TO [00:54:25.60] WHAT THE PERSON DOES UNDERSTAND [00:54:27.40] AND WHY THEY'RE DOING WHAT [00:54:28.90] THEY'RE DOING CAN HELP SORT OUT [00:54:30.83] THOSE DIFFERENCES. [00:54:32.27] THEN YOU ASKED ABOUT, YOU KNOW, [00:54:33.90] WHAT SHOULD WE SAY ABOUT [00:54:36.07] BENEFIT? [00:54:38.77] WELL, I THINK WE DON'T DO A VERY [00:54:40.33] GOOD JOB IN CONSENT FORMS WITH [00:54:42.17] BENEFIT LANGUAGE, AND SOME OF [00:54:43.70] THAT ACTUALLY IS BECAUSE IRB'S [00:54:46.10] ARE REALLY -- YOU KNOW, THEY [00:54:47.10] DON'T LIKE THE FACT THAT WE SAY [00:54:48.53] YOU MIGHT BENEFIT HERE OR YOU [00:54:50.10] MIGHT HELP SOCIETY. [00:54:52.10] SOMETIMES THE IRB'S TAKE THAT [00:54:54.03] OUT OF THERE. [00:54:54.87] BUT THAT'S REALLY WHAT, IN MY [00:54:57.10] HUMBLE OPINION, WE SHOULD BE [00:54:58.30] TELLING PEOPLE BECAUSE IN SOME [00:54:59.93] CASES WE DO HAVE DATA THAT [00:55:02.07] SUGGESTS THAT THEY MIGHT [00:55:03.53] BENEFIT, BUT THEY ALSO HAVE TO [00:55:04.80] KNOW THAT THEY MIGHT NOT. [00:55:05.73] I MEAN, YOU HAVE TO GIVE THEM [00:55:08.13] THE CONTEXT. [00:55:08.93] WE ALSO, I THINK, OWE IT TO [00:55:12.03] PEOPLE TO BE CLEAR ABOUT THE [00:55:13.63] FACT THAT THEY ARE DOING THIS TO [00:55:17.27] HELP OTHERS AND SOME PEOPLE [00:55:18.47] REALLY FIND THAT VERY APPEALING. [00:55:22.40] SO I DON'T THINK WE NEED TO HIDE [00:55:25.03] IT. [00:55:25.20] >> THANK YOU. [00:55:26.63] >> Christine Grady: OKAY. [00:55:27.20] WITH THAT, I'M GOING TO [00:55:27.93] INTRODUCE OUR NEXT SPEAKER, WHO [00:55:30.70] IS GOING TO TALK WITH YOU TODAY [00:55:33.80] ABOUT RESEARCH INVOLVING PERSONS [00:55:35.07] AT RISK FOR IMPAIRED [00:55:36.70] DECISION-MAKING. [00:55:37.07] SO PEOPLE WHO MIGHT HAVE [00:55:41.33] IMPAIRMENT IN THEIR ABILITY TO [00:55:42.83] GIVE INFORMED CONSENT. [00:55:44.90] WITH US TODAY TO DO THAT IS [00:55:46.67] SCOTT KIM WHO IS A MEMBER OF THE [00:55:48.53] FACULTY IN THE DEPARTMENT OF [00:55:50.80] BIOETHICS HERE AT THE CLINICAL [00:55:52.40] CENTER, HE'S A PSYCHIATRIST AND [00:55:53.60] PHILOSOPHER AND HAS DONE [00:55:54.37] PROBABLY MORE WORK ON THIS TOPIC [00:55:57.93] OF PERSONS WHO HAVE IMPAIRED [00:55:59.77] DECISION-MAKING BOTH IN [00:56:00.77] HEALTHCARE AND IN CLINICAL [00:56:02.10] RESEARCH THAN ALMOST ANYBODY. [00:56:03.87] SO SCOTT? [00:56:36.97] >> Christine Grady: THANK YOU. [00:56:37.63] >> Scott Kim: THANK YOU, [00:56:39.10] CHRISTINE. [00:56:39.37] I THINK WE'RE SUPPOSED TO CLAP [00:56:41.83] AFTER HER. [00:56:43.47] [APPLAUSE] [00:56:43.73] >> Scott Kim: MAYBE NEXT YEAR I [00:56:44.50] CAN GIVE A TALK ON THERAPEUTIC [00:56:46.97] MISCONCEPTION. [00:56:47.30] I'M NOT VERY GOOD AT THIS HERE. [00:56:49.07] GIVE ME A SECOND. [00:56:49.97] I KNOW WHAT IT IS, IT'S MY ID, [00:56:53.73] MY DOG TAG IS GETTING IN MY WAY [00:56:55.47] AND I'M GETTING CONFUSED. [00:57:03.90] CAN YOU HEAR ME? [00:57:05.53] OKAY? [00:57:05.73] >> YEAH. [00:57:06.80] >> Scott Kim: ALL RIGHT. [00:57:10.50] THANK YOU, CHRISTINE. [00:57:27.00] I'M GOING ON WALK AROUND LIKE [00:57:28.47] CHRISTINE DID. [00:57:28.90] YOU CAN HEAR ME OKAY IN THE BACK [00:57:30.43] AND EVERYTHING, RIGHT? [00:57:33.37] OKAY. [00:57:33.67] SO I'M SUPPOSED TO PUT THIS UP. [00:57:36.67] SO THIS YEAR IS THE 50TH [00:57:38.50] ANNIVERSARY OF A FAMOUS ARTICLE, [00:57:40.20] I'M SURE YOU'VE ALL BEEN TOLD [00:57:42.10] ABOUT, RIGHT, AND YOU MAY EVEN [00:57:43.77] HAVE READ IT AS PART OF THIS [00:57:45.63] COURSE, AND I JUST WANT TO START [00:57:47.23] WITH THIS BECAUSE IN THAT PAPER [00:57:49.33] THERE WERE ABOUT 22 EXAMPLES OF [00:57:52.37] STUDIES THAT DR. BEECHER THOUGHT [00:57:55.60] WERE UNETHICAL AND ONE OF THE [00:57:57.07] INTERESTING THINGS ABOUT THAT IS [00:57:58.10] THAT ALMOST HALF, MAYBE NOT [00:57:59.90] QUITE HALF, INVOLVE EXAMPLES OF [00:58:02.17] PEOPLE WHO PROBABLY HAD TROUBLE [00:58:03.90] GIVING CONSENT, COULD BE [00:58:05.53] CHILDREN, PEOPLE WITH COGNITIVE [00:58:07.13] IMPAIRMENT AND THINGS LIKE THAT, [00:58:09.30] AND YOU DON'T HAVE TO GO THROUGH [00:58:11.07] THESE, BUT I JUST WANTED TO [00:58:12.37] POINT THIS OUT, THAT THIS ISSUE [00:58:15.67] OF RESEARCH WITH PEOPLE WHO [00:58:17.83] CAN'T GIVE THEIR OWN CONSENT OR [00:58:19.83] WOULD BE IMPAIRED IN BEING ABLE [00:58:22.03] TO DO SO HAS BEEN AT THE [00:58:25.77] BEGINNING OF ALL THE [00:58:27.60] CONTROVERSIES THAT LED TO THE [00:58:29.47] HUMAN SUBJECT PROTECTION SYSTEM [00:58:31.10] THAT WE HAVE TODAY. [00:58:33.07] SO THIS IS A VERY HISTORICALLY [00:58:36.60] RELEVANT TOPIC AND IRONICALLY AS [00:58:38.27] YOU WILL SEE, THERE WERE MANY [00:58:41.40] COMMISSIONS WHO HAVE ADDRESSED [00:58:42.83] THIS ISSUE. [00:58:43.57] THE VERY FIRST ONE BEING THE [00:58:46.83] NATIONAL COMMISSION IN 1978. [00:58:49.07] YOU'VE ALL READ THE BELMONT [00:58:51.90] REPORT, RIGHT? [00:58:52.73] OKAY. [00:58:52.93] THESE ARE THE GROUP OF PEOPLE [00:58:55.37] WHO WROTE THAT REPORT. [00:58:56.60] THEY ADDRESSED THIS. [00:58:57.57] THEY WROTE A REPORT WHICH IS [00:59:00.10] VERY GOOD. [00:59:00.73] IT DIDN'T BECOME PART OF THE [00:59:02.67] REGULATIONS, THOUGH, WHICH IS [00:59:04.23] INTERESTING BECAUSE THAT WAS THE [00:59:06.77] ONLY -- IT MIGHT BE THE ONLY [00:59:07.90] REPORT THEY WROTE. [00:59:08.63] THEY WROTE A BUNCH OF THEM, AND [00:59:10.73] ALL OF THEM BECAME PART OF WHAT [00:59:12.27] ARE NOW THE REGULATIONS THAT WE [00:59:16.03] HAVE, EXCEPT THIS REPORT. [00:59:19.27] AND THEN PRESIDENT CARTER HAD A [00:59:21.73] COMMISSION, THEY TRIED IT AGAIN, [00:59:24.07] IT DIDN'T BECOME SETTLED, IN [00:59:28.27] MARYLAND THE ATTORNEY GENERAL [00:59:29.10] HAD A WORKING GROUP IN 1998, [00:59:31.10] THERE WAS ANOTHER NATIONAL [00:59:32.63] COMMISSION UNDER PRESIDENT [00:59:35.30] CLINTON, AGAIN, MADE [00:59:38.83] RECOMMENDATIONS, IT DIDN'T [00:59:39.50] REALLY BECOME PART OF ANY KIND [00:59:41.57] OF REGULATORY APPARATUS. [00:59:45.07] THE NEW YORK DEPARTMENT OF [00:59:46.47] HEALTH ALSO HAD A WORKING GROUP [00:59:49.40] AROUND THE SAME TIME. [00:59:54.07] IT LED TO SOME CHANGES IN THE [00:59:55.73] STATE REGULATIONS. [00:59:57.33] AND THEN WHAT'S CALLED THE [00:59:59.67] SECRETARY'S ADVISORY COMMITTEE [01:00:01.17] ON HUMAN RESEARCH PROTECTION, [01:00:02.37] THIS IS AN ENTITY UNDER THE HHS [01:00:06.63] WHICH STILL EXISTS, THEY DO [01:00:08.27] REALLY EXCELLENT WORK. [01:00:09.73] I MEAN, IT'S COMPRISED OF VERY [01:00:13.23] KNOWLEDGEABLE PEOPLE IN RESEARCH [01:00:14.70] ETHICS WHO ARE INVITED TO USE [01:00:17.93] THEIR EXPERTISE TO COME UP WITH [01:00:20.30] GUIDANCE ON UNSETTLED TOPICS [01:00:22.60] USUALLY, AND THEY'VE ACTUALLY [01:00:23.90] HAD TWO REPORTS ON THIS TOPIC [01:00:25.63] AND THE SECOND ONE BEING IN [01:00:29.60] 2009. [01:00:29.80] AND THEN THE CURRENT [01:00:33.17] PRESIDENTIAL COMMISSION UNDER [01:00:34.70] PRESIDENT OBAMA ALSO ISSUED A [01:00:36.57] REPORT ON THIS VERY SAME TOPIC. [01:00:39.00] SO IT'S A TOPIC THAT GETS [01:00:41.13] ADDRESSED A LOT. [01:00:42.40] IT STARTED, YOU KNOW, WAY BACK. [01:00:44.73] BUT AS YOU WILL SEE, IT'S STILL [01:00:47.03] QUITE UNSETTLED. [01:00:48.23] OKAY. [01:00:48.43] SO WHAT I'M GOING TO DO IS JUST [01:00:50.60] TELL YOU WHAT DECISION-MAKING [01:00:52.57] CAPACITY IS CONCEPTUALLY AND HOW [01:00:54.47] WE ASSESS IT AND ASK THE [01:00:57.37] QUESTION, ARE STUDIES THAT [01:00:58.90] INVOLVE PEOPLE WHO LACK THAT [01:01:01.50] CAPACITY PER MISCIBLE ETHICALLY [01:01:03.20] AND LEGALLY -- PERMISSIBLE ELT [01:01:06.77] CLI AND LEGALLY? [01:01:08.23] IF IT IS PERMISSIBLE, WHICH IT [01:01:09.80] IS, NO SURPRISE -- YOU CAN LEAVE [01:01:12.30] NOW SINCE YOU KNOW THE ANSWER. [01:01:16.23] [LAUGHTER] [01:01:16.63] >> Scott Kim: WHO SHOULD GIVE [01:01:18.13] CONSENT? [01:01:18.40] THIS IS A BIG SH EWE. [01:01:19.27] WHO IS GOING TO TAKE [01:01:20.33] RESPONSIBILITY FOR THAT PERSON [01:01:21.07] BEING IN THE STUDY? [01:01:24.93] AND HOW SHOULD THEY DECIDE IT? [01:01:26.70] SHOULD THERE BE OTHER [01:01:27.90] PROTECTIONS? [01:01:28.20] SHOULD THERE BE LIMITS AND RISK [01:01:29.87] LEVELS, OTHER PROTECTIONS AND SO [01:01:31.20] FORTH, AND THE LAST FEW SLIDES [01:01:32.53] WHAT I'M GOING TO DO IS TO GO [01:01:37.53] THROUGH THE NIH'S SOP, STANDARD [01:01:41.50] OPERATING PROCEDURES, JUST TO [01:01:42.33] SHOW YOU AS AN COMAMPLE OF HOW [01:01:48.77] THE INSTITUTION THAT YOU'RE [01:01:49.63] SITTING IN TODAY HAS DECIDED [01:01:50.83] THOOND HE WILL THIS QUESTION. [01:01:55.50] OKAY. [01:01:56.67] SO DECISION-MAKING CAPACITY AT [01:01:57.80] LEAST IN THE UNITED STATES IS [01:01:59.30] SEEN AS PORT PART OF THE [01:02:01.57] INFORMED CONSENT DOCTRINE, WHICH [01:02:02.93] HAS THREE PARTS, ONE IS THAT THE [01:02:04.40] PERSON HAS TO BE CAPABLE OF [01:02:05.80] GIVING INFORMED CONSENT, RIGHT, [01:02:07.60] THEY HAVE TO BE GIVEN ADEQUATE [01:02:11.60] INFORMATION. [01:02:12.07] NOW, IT'S NOT THAT -- THERE IS [01:02:14.20] SOME CONTROVERSY ABOUT THIS, [01:02:19.00] TRARK, BUT IT'S NOT LIKE WE CAN [01:02:21.37] ENSURE PEOPLE UNDERSTAND IT, YOU [01:02:22.07] HAVE TO MAKE SURE THAT THEY'RE [01:02:24.53] CAPABLE OF UNDERSTANDING IT, [01:02:25.73] LASTLY, YOU CAN'T COERCE OR [01:02:27.50] UNDULY INFLUENCE THEM, SO IT HAS [01:02:29.40] TO BE VOLUNTARY. [01:02:30.50] WE TALKED ABOUT THE FIRST [01:02:35.17] ELEMENT. [01:02:37.53] THE MOST IMPORTANT THING TO [01:02:38.47] REMEMBER IS THAT IT IS FUNCTION [01:02:40.37] BASED. [01:02:40.60] IT SOUNDS LIKE WHAT THE NAME IS, [01:02:42.87] DECISION-MAKING CAPACITY. [01:02:43.40] SO IT'S NOT BASED ON SOME [01:02:46.63] OLD-FASHIONED DIAGNOSIS, YOU [01:02:47.63] KNOW, TURN OF THE CENTURY, 19TH [01:02:49.63] OR 20TH CENTURY, PEOPLE MIGHT [01:02:51.77] GET HOSPITALIZED AND COMMITTED [01:02:52.93] TO AN ASYLUM BECAUSE A SPOUSE [01:02:55.47] SAYS MY WIFE IS SENILE OR HAS AN [01:03:00.23] UNSOUND MIND, THAT'S WHEN A [01:03:03.07] DOCTOR WOULD SHOW UP AND SAY [01:03:04.43] YES, I AGREE, SHE HAS AN UNSOUND [01:03:06.63] MIND. [01:03:06.90] WE DON'T DO THAT I AM IN. [01:03:08.07] IT HAS TO BE -- WE DON'T DO THAT [01:03:10.57] ANYMORE. [01:03:10.80] IT HAS TO BE BASED ON THE ACTUAL [01:03:12.87] FUNCTIONAL ELEMENTS OF MAKING [01:03:13.73] DECISIONS AND WE HAVE TO ASSESS [01:03:15.10] THAT. [01:03:15.53] THE THRESHOLD, IN OTHER WORDS, [01:03:16.90] SINCE WE ALL HAVE DIFFERENT [01:03:18.10] LEVELS OF CAPACITY, THE QUESTION [01:03:23.17] IS AT WHAT LEVEL OF CAPACITY OR [01:03:24.60] ABILITIES ARE WE GOING TO [01:03:27.47] DROUGHT LINE AND THAT GETS [01:03:31.37] AFFECTED BY CONTEXTUAL FACTORS, [01:03:34.87] ONE OF THE MOST IMPORTANT BEING [01:03:35.87] HOWMP IS AT STAKE? [01:03:36.93] IF A LOT IS AT STAKE, YOU WANT [01:03:38.33] TO MAKE SURE YOU DO BOTH EXTREME [01:03:41.40] SCRUTINY OF THE DECISION-MAKING [01:03:43.13] ABILITIES BUT ALSO THAT THEY [01:03:45.40] ACTUALLY CLEARLY HAVE [01:03:46.27] SUFFICIENTLY HIGH LEVEL OF [01:03:47.60] DECISION-MAKING CAPACITY. [01:03:52.73] I'M GOING TO GO THROUGH [01:03:57.40] DEFINITIONS BECAUSE EVERY TIME I [01:03:58.50] GIVE THIS TALK, NOT IN THIS [01:04:00.53] VENUE NECESSARILY, BUT IN [01:04:01.97] HOSPITALS, SOMEBODY COMPLAINS [01:04:03.03] THEY DON'T KNOW WHAT I'M TALKING [01:04:04.20] ABOUT BECAUSE I'M USING THE WORD [01:04:07.83] CAPACITY AND COMPETENCE [01:04:09.30] INTERCHANGEABLY AND SOMEBODY [01:04:10.03] SAYS YOU SHOULD KNOW BETTER [01:04:11.17] BECAUSE COMPETENCE IS THE LEGAL [01:04:12.80] TERM AND CAPACITY IS JUST THE [01:04:14.57] CLINICAL. [01:04:15.00] WELL, THAT'S NOT TRUE. [01:04:16.00] THE BEST WAY TO THINK ABOUT [01:04:17.20] THOSE TWO ERNLINGSZ IT YOU'LL [01:04:18.83] HEAR THIS FROM VARIOUS PEOPLE S [01:04:20.70] THE FOLLOWING WAY. [01:04:25.00] ONE, THERE'S THE STATUS OF [01:04:27.07] HAVING BEEN ADJUDICATED, IN [01:04:28.27] OTHER WORDS, A JUDGE MAGICALLY [01:04:29.63] SAYS BOOM, YOU ARE NOW [01:04:32.60] INCOMPETENT OR INCAPACITATED. [01:04:34.20] HE MIGHT USE BOTH TERMS. [01:04:36.37] WHY? [01:04:36.57] BECAUSE MOST MODERN LAWS USE THE [01:04:40.63] TERM DECISION-MAKING CAPACITY IN [01:04:41.80] THE LAWS THEMSELVES. [01:04:45.50] IN FACT, IT'S HARD TO FIND THE [01:04:47.00] TERM COMPETENCE IN CL MODERN [01:04:49.07] HEALTHCARE LAWS THAT REFER TO [01:04:51.73] THIS CONCEPT. [01:04:52.97] WE ALSO USE THE TERM CAPACITY [01:04:54.53] AND COMPETENCE IN THE CLINICAL [01:04:55.73] SETTING, LIKE IN THIS HOSPITAL [01:04:57.87] IN THE CLINICAL CENTER HOSPITAL [01:05:03.43] BECAUSE OBVIOUSLY NOT EVERY [01:05:04.70] SINGLE CASE NEEDS TO GO TO COURT [01:05:07.17] AND PHYSICIANS HAVE THE LEGAL [01:05:13.00] RESPONSIBILITY ACTUALLY TO [01:05:13.70] DETERMINE A PERSON'S CAPACITY, [01:05:15.83] IN OTHER WORDS, WHAT A JUDGE [01:05:17.27] MIGHT DECIDE, BUT YOU USE THAT [01:05:19.00] IN THE CLINICAL SETTING. [01:05:20.20] AND THAT'S WHAT WE RELY ON ALL [01:05:23.03] THE TIME, EXCEPT FOR A FEW CASES [01:05:27.90] WHERE REALLY CERTAINLY YOU HAVE [01:05:28.83] TO GO TO COURT. [01:05:29.60] FOR EXAMPLE, YOU CAN'T DO [01:05:31.27] INVASIVE SURGERY ON SOMEBODY IF [01:05:32.53] THAT PERSON REFUSES AND YOU [01:05:33.57] THINK THAT PERSON IS [01:05:35.17] INCOMPETENT, YOU CAN'T SAY, [01:05:36.23] WELL, I THINK A JUDGE WOULD SAY [01:05:38.27] YOU'RE INCOMPETENT TEFNT, SO [01:05:38.97] WE'RE GOING TO DO SURGERY. [01:05:40.50] YOU ACTUALLY HAVE TO CALL A [01:05:41.70] JUDGE IN THAT CASE. [01:05:43.37] THERE ARE SPECIAL PROCEDURES [01:05:44.80] LIKE ECT, USE OF PSYCHOTROPIC [01:05:47.53] MEDICATIONS, ADMISSIONS TO [01:05:48.40] CERTAIN UNITS, THINGS LIKE THAT, [01:05:49.73] THAT REALLY EXPLICITLY ARE LAID [01:05:52.03] OUT IN LAW, BUT USUALLY MOST [01:05:53.60] OTHER THINGS IT'S NOT. [01:05:59.10] THEN THE CAPACITY IS BROKEN DOWN [01:06:00.77] INTO FUNCTIONAL ELEMENTS THAT [01:06:01.90] HAVE TO DO WITH BEING ABLE TO [01:06:03.37] UNDERSTAND 9 -- TO UNDERSTAND [01:06:06.23] THE FACT, UNDERSTANDING, BEING [01:06:07.60] ABLE TO APPRECIATE, MEANING [01:06:08.73] BEING ABLE TO APPLY THE FACTS OF [01:06:11.60] THE MATTER TO YOUR OWN [01:06:13.20] SITUATION. [01:06:13.47] SO FOR EXAMPLE, I HAD A PATIENT [01:06:17.80] WHO WAS CONVINCED THAT SHE HAD A [01:06:19.50] SYSTEMIC FUNGAL INFECTION. [01:06:23.53] IN FACT, SHE WAS SO GOOD AT [01:06:25.90] CONVINCING DOCTORS THAT BY THE [01:06:26.83] TIME I SAUL HER ON THE [01:06:27.90] PSYCHIATRIC UNIT, SHE HAD HAD A [01:06:29.27] CENTRAL LINE PLACED, PERMANENT [01:06:30.97] CENTRAL LINE LIKE A HIC -- I [01:06:34.50] FORGET THE NAME OF THE ONE THAT [01:06:35.63] SHE H BUT SHE HAD ONE BECAUSE [01:06:37.13] YOU NEEDED IV FUNGAL, YOU KNOW, [01:06:39.40] WHATEVER. [01:06:39.70] IT TURNED OUT SHE WAS [01:06:42.70] DELUSIONAL. [01:06:43.03] SO IF YOU ASKED HER, WELL, WHAT [01:06:46.07] HAVE THE DOCTORS TOLD YOU ABOUT [01:06:47.60] YOUR CONDITION? [01:06:48.50] SHE WOULD TELL ME PERFECTLY [01:06:50.00] ACCURATELY WHAT THE DOCTORS [01:06:52.20] SAID, BUT THEN SO I SAID, WELL, [01:06:54.63] THEN, HOW COME YOU'RE REFUSING [01:06:57.00] TO LET US TAKE THAT OUT? [01:06:58.63] SHE WOULD SALE THEY'RE NOT [01:07:00.17] DOCTORS, THEY'RE CIA AGENTS WHO [01:07:01.63] ARE OUT TO HARM ME, RIGHT, OR [01:07:03.43] SOMETHING TO THAT EFFECT. [01:07:04.63] SO SHE COULDN'T APPLY THE FACTS [01:07:08.30] TO HER SITUATION APPRECIATION. [01:07:10.20] REASONING IS A VERY BROAD [01:07:11.63] CATEGORY THAT HAS TO DO WITH ALL [01:07:12.90] THE ELEMENTS THAT GO INTO THE [01:07:15.57] PROCESS OF REASONING, NOT THAT [01:07:17.10] IT'S A REASONABLE CHOICE. [01:07:18.43] OKAY? [01:07:18.63] NOT THAT WE HAVE TO AGREE WITH [01:07:20.27] IT. [01:07:20.87] AND COMMUNICATING A STABLE [01:07:26.30] CHOICE IS EXACTLY WHAT IT SAYS, [01:07:27.63] IF I CAN'T STABLY EXPRESS A [01:07:29.17] PREFERENCE SO YOU UNDERSTAND [01:07:30.17] WHAT I WANT, THEN MY CAPACITY IS [01:07:31.63] VERY HARD TO ASSESS. [01:07:37.03] OKAY. [01:07:37.23] THE THING TO KNOW IS THAT THESE [01:07:39.17] ABILITIES CAN, LIKE MOST HUMAN [01:07:44.27] PHENOMENA, BEHAVIOR, YOU CAN [01:07:45.93] MEASURE T YOU KNOW, YOU ASK A [01:07:47.23] PSYCHOLOGIST AND THEY'LL COME UP [01:07:48.40] WITH AN INSTRUMENT THAT YOU CAN [01:07:50.23] MEASURE IT, OF UNDERSTANDING, [01:07:51.77] APPRECIATION AND SO FORTH. [01:07:52.90] BUT IT'S A MATTER OF DEGREE. [01:07:54.43] SO YOU CAN COME UP WITH A [01:07:56.40] RELIABLE AND VALID MEASURE OF [01:07:58.63] THE DOMAIN, BUT YOU HAVE TO [01:08:01.93] TRANSLATE THAT INTO A [01:08:04.33] DICHOTOMOUS DECISION, RIGHT? [01:08:06.03] YES, THIS PERSON IS CAPABLE, [01:08:07.83] THIS PERSON IS NOT. [01:08:08.97] THAT DECISION, USING THE DATA, [01:08:10.47] IS A JUDGMENT CALL. [01:08:11.70] THERE'S NO LAW THAT SAYS YOU [01:08:12.73] HAVE TO USE THIS INSTRUMENT WITH [01:08:14.53] THIS NUMBER BECAUSE IT DEPENDS [01:08:16.00] ON THE CONTEXT AND IT VARIES [01:08:17.60] QUITE A BIT. [01:08:18.90] SO THAT'S WHAT MAKES THIS [01:08:21.97] PARTICULARLY DIFFICULT. [01:08:24.00] OKAY. [01:08:24.87] NOW, SOME DISORDERS ARE RISK [01:08:29.23] FACTORS FOR INCAPACITY, [01:08:31.83] OBVIOUSLY COGNITIVE DISORDERS [01:08:34.03] LIKE NEURODEGENERATIVE [01:08:35.23] DISORDERS, ALZHEIMER'S DISEASE, [01:08:42.50] FRONTO-TELL RESIDUAL DEMENTIA, [01:08:45.80] THEN THERE ARE PEOPLE WITH [01:08:47.00] INCIDENT ELECTRICITY YUL [01:08:47.97] DISABILITIES, YOU CAN HAVE [01:08:48.50] INJURIES TO YOUR BRAIN FOR A [01:08:51.17] VARIETY OF REASONS OR YOU CAN BE [01:08:53.30] IN AN ACUTE CONFUSIONAL STATE, [01:08:55.13] WHICH WE CALL CLINICALLY [01:08:58.87] DELIRIUM, RIGHT? [01:09:00.23] PSYCHOTIC DISORDERS, INCLUDING [01:09:01.47] MANIA, I TEND ON THINK OF A [01:09:04.43] MANIC STATE IN A PERSON WHO HAS [01:09:06.67] BIPOLAR DISORDER AS BEING IN A [01:09:07.50] STATE OF PSYCHOSIS, MOOD [01:09:12.90] DISORDERS, SEVERE DEPRESSION [01:09:14.07] SOMETIMES CAN CAUSE INCAPACITY, [01:09:16.13] EXTREME EATING DISORDERS CAN [01:09:19.53] CAUSE THAT TOO. [01:09:22.47] SOME MORE CONTROVERSIAL AREAS, [01:09:23.70] PEOPLE HAVE VERY, VERY EXTREME [01:09:25.53] PERSONALITY DISORDERS. [01:09:26.50] THERE'S SOME DEBATE ABOUT HOW DO [01:09:28.57] YOU CONCEPTUALIZE A SITUATION [01:09:30.30] LIKE THAT, OR PEOPLE WITH SEVERE [01:09:32.50] ADDICTIONS, BUT WE'RE NOT GOING [01:09:33.60] TO GO INTO THOSE DETAILS TODAY. [01:09:35.17] THE MAIN THING I WANT YOU TO [01:09:36.30] TAKE AWAY FROM THIS IS THAT [01:09:37.67] THESE PUT YOU AT RISK, BUT YOU [01:09:40.80] CAN'T SIMPLY BECAUSE YOU HAVE A [01:09:43.20] DIAGNOSIS DOESN'T MEAN YOU HAVE [01:09:44.47] INCAPACITY, RIGHT? [01:09:45.33] OKAY. [01:09:45.60] THESE ARE JUST VERY ROUGH [01:09:48.30] ESTIMATES. [01:09:48.80] IF YOU'VE BEEN LISTENING TO WHAT [01:09:49.87] I'VE BEEN SAYING, YOU WOULD [01:09:50.90] THINK, WELL, HOW CAN YOU SAY [01:09:52.27] THIS, SINCE IT DEPENDS ON [01:09:53.97] CONTEXT AND SO FORTH? [01:09:55.43] SO WITH ALL THOSE CAVEATS, THESE [01:09:57.60] ARE JUST APPROXIMATE. [01:09:58.93] SO IF YOU GO TO A HOSPITAL, [01:10:01.50] GENERAL HOSPITAL, YOU WILL SEE, [01:10:03.13] YOU KNOW, PROBABLY 30 TO 40% OF [01:10:05.83] THE PEOPLE WHO ARE LYING IN BED [01:10:07.23] IN THE HOSPITAL, IF YOU STARTED [01:10:10.90] TALK TO GO THEM, WILL REALIZE [01:10:12.47] THEY JUST AREN'T CAPABLE OF [01:10:13.73] MAKING THEIR OWN DECISIONS. [01:10:15.10] NURSING HOMES, MUCH HIGHER. [01:10:16.77] PSYCHIATRIC HOSPITAL, DEPENDING [01:10:17.83] ON THE STUDY. [01:10:20.60] WITH PEOPLE WITH CHRONIC [01:10:23.57] PSYCHOSES, SCHIZOPHRENIA, THE [01:10:25.30] NUMBERS VARY FROM 25 TO 50%, [01:10:28.03] WHAT'S NOTICEABLE ABOUT THIS IS [01:10:29.30] THAT THESE ARE PEOPLE WHO HAVE [01:10:31.30] PRETTY SEVERE MENTAL DISORDERS, [01:10:33.03] RIGHT? [01:10:33.93] SCHIZOPHRENIA. [01:10:34.67] BUT NOTICE THIS MEANS THAT HALF [01:10:36.63] OF THEM ARE ABLE TO MAKE MOST [01:10:38.93] DECISIONS ON THEIR OWN. [01:10:41.33] INDEED LEGALLY THEY HAVE THE [01:10:43.20] PRESUMPTION OF CAPACITY. [01:10:44.93] MILD TO MODERATE DEPRESSION HAS [01:10:47.57] RELATIVELY LITTLE IMPACT. [01:10:48.50] IN FACT, EVEN INPATIENTS SEVERE [01:10:52.23] DEPRESSION, DEPENDING ON THE [01:10:53.43] STUDY, IT'S FAIRLY LOW. [01:10:55.07] HOWEVER, SEVERELY DEPRESSED [01:10:56.93] PEOPLE, IT'S PROBABLY GREATER [01:10:57.90] THAN A QUARTER OF THE PEOPLE MAY [01:10:59.47] HAVE THAT. [01:10:59.83] OF COURSE, IT DEPENDS ON THE [01:11:01.17] DECISION AT ISSUE. [01:11:02.10] IF IT'S A MINOR DECISION, WHICH [01:11:03.77] IT DOESN'T TAKE A LOT TO DECIDE, [01:11:05.77] THEY'LL PROBABLY BE COMPETENT. [01:11:07.33] IF IT'S A MAJOR DECISION, LIFE [01:11:09.73] AND DEATH DECISION THAT HAS [01:11:11.37] COMPLICATED PROCEDURAL ELEMENTS, [01:11:12.40] THEY MAY NOT UNDERSTAND IT. [01:11:13.60] SO IT REALLY WILL DEPEND. [01:11:20.83] NOW, YOU'RE HERE BECAUSE YOU'RE [01:11:24.03] HERE TO TALK ABOUT RESEARCH [01:11:27.90] INVOLVING PEOPLE WHO HAVE [01:11:31.43] DECISION-MAKING IMPAIRMENT. [01:11:32.17] SO THE TWO MOST COMMON TYPES OF [01:11:34.10] SITUATIONS, I'M NOT TALKING [01:11:35.27] ABOUT CHILDREN WHO HAVE [01:11:39.43] INCOMPETENT DUE TO THEIR STATUS, [01:11:40.77] NOT BECAUSE OF THEIR FUNCTION, [01:11:44.47] RIGHT? [01:11:44.80] FOR PEOPLE WHO HAVE ALZHEIMER'S, [01:11:46.63] WHICH IS THE MOST COMMON TYPE OF [01:11:49.43] NEURODEGENERATIVE COGNITIVE [01:11:53.77] DISORDER, WHERE KIND OF THE [01:11:56.57] PREDEMENTIA STATE OF MILD [01:11:58.40] COGNITIVE IMPAIRMENT, EVEN WITH [01:12:01.23] THE MENTAL STATE THAT'S LARGELY [01:12:03.30] NORMAL ACCORDING TO SOME PEOPLE, [01:12:04.60] DEPENDING ON YOUR EDUCATION [01:12:06.20] LEVEL, 40% OF THE PEOPLE ARE [01:12:09.37] SEEN TO LACK CAPACITY TO CONSENT [01:12:13.03] TO A RANDOMIZED CLINICAL TRIAL. [01:12:14.93] THAT'S A PRETTY HIGH NUMBER. [01:12:17.13] WE'RE TALKING ABOUT PEOPLE WHERE [01:12:18.57] IF YOU WERE JUST IN A CASUAL [01:12:19.80] CONVERSATION ABOUT THE WEATHER, [01:12:20.80] HOW THINGS ARE GOING, HOW ABOUT [01:12:22.20] THEM JETS, THAT KIND OF [01:12:23.60] CONVERSATION, YOU WOULDN'T KNOW [01:12:24.93] THEY WERE REALLY THAT IMPAIRED. [01:12:26.87] IT'S ONLY WHEN YOU START ASKING [01:12:29.33] QUESTIONS ABOUT THE NOVEL [01:12:32.27] INFORMATION THEY HAVE TO TAKE IN [01:12:33.33] TO MAKE THIS DECISION DO YOU [01:12:34.80] REALIZE THIS. [01:12:35.53] THIS IS THE CLASSIC SCENE IN THE [01:12:37.60] HOSPITAL WHERE YOU GO TO A [01:12:39.33] BEDSIDE OF AN ELDERLY PATIENT [01:12:41.23] AND YOU START TALKING AND ALL [01:12:43.63] THE YOUNG MEMBERS OF THE [01:12:45.33] ROUNDING TEAM THINK OH, SHE'S [01:12:46.87] GREAT, DOING FINE, THEN THE [01:12:48.50] ATTENDING STARTS ASKING SOME [01:12:50.03] POINTED QUESTIONS AND THEY [01:12:51.17] REALIZE, OH, MY GOSH, MRS. JONES [01:12:53.17] IS REALLY DEMEANTED, YOU KNOW. [01:12:55.37] -- DEMENTED, YOU KNOW, IT'S THAT [01:12:57.93] KIND OF THING. [01:12:58.77] AND BY THE TIME THEY HAVE THE [01:13:01.53] DIAGNOSIS WITH MINI MENTALES IN [01:13:03.10] THIS RANGE, FOR THOSE OF WHO YOU [01:13:05.00] ARE NOT FAMILIAR WITH A MINI [01:13:06.77] MENTAL, HOW MANY OF YOU KNOW [01:13:07.87] WHAT THAT IS? [01:13:10.23] ABOUT HALF. [01:13:11.00] IT'S A 0 TO 30 POINT QUICK [01:13:12.90] SCREEN, IT'S NOT THAT GREAT, BUT [01:13:14.73] HISTORICALLY IT'S WHAT WE'RE [01:13:16.03] STUCK WITH SO WE TEND TO USE [01:13:17.27] THAT A LOT SO WHEN YOU HAVE 22, [01:13:24.43] 23, MAJORITY PROBABLY CAN'T MAKE [01:13:25.43] THEIR OWN DECISIONS. [01:13:26.90] NOW, ON THE OTHER HAND, PEOPLE [01:13:28.00] WITH SCHIZOPHRENIA, THIS IS FROM [01:13:30.13] THE CADY STUDY, DONE YEARS AGO, [01:13:33.57] IT'S ONE OF THE FIRST [01:13:34.77] EFFECTIVENESS STUDIES, WHICH [01:13:35.60] MEANS THAT THE ENTRY CRITERIA [01:13:37.33] WAS VERY BROAD, VIRTUALLY [01:13:41.10] ANYBODY WHO HAD A DIAGNOSIS [01:13:42.23] COULD BE IN THIS STUDY, SO IT [01:13:43.83] GIVES YOU A PRETTY GOOD MEASURE [01:13:45.30] OF THE PREVALENCE OF INCAPACITY [01:13:46.80] IN PEOPLE WITH THIS DIAGNOSIS, [01:13:48.97] AND YOU'LL SEE FOR THE MEASURE [01:13:51.50] OF UNDERSTANDING THESE ARE THE [01:13:53.07] SCORES WHERE THE MAXIMUM WAS 26, [01:14:03.33] THCHES THE CUTOFF THAT THE TEAM [01:14:05.40] DECIDED TO USE, AND YOU'LL SEE [01:14:07.37] THAT FOR THIS GROUP, [01:14:09.10] OVERWHELMING MAJORITY OF PEOPLE [01:14:10.20] WERE ABOVE THAT THRESHOLD, SO [01:14:11.67] THIS IS QUITE A CONTRAST FROM [01:14:13.23] THE ALZHEIMER'S. [01:14:16.33] HERE APPRECIATION IS A LITTLE [01:14:18.50] BIT MORE, BUT STILL, SO THIS [01:14:22.00] REALLY DEPENDS ON THE DIAGNOSIS. [01:14:23.67] THIS IS USING VERY SIMILAR [01:14:25.40] MEASURES THAT I TALKED ABOUT [01:14:27.50] COMPARING THE ALZHEIMER'S AND [01:14:30.20] SCHIZOPHRENIA. [01:14:30.73] OKAY. [01:14:32.17] NOW, KEEP THOSE SLIDES ABOUT [01:14:34.40] ALZHEIMER'S AND SCHIZOPHRENIA IN [01:14:38.37] MIND TOWARD THE END OF THE TALK [01:14:40.03] WHERE I'M GOING TO TALK ABOUT [01:14:40.97] THE IMPORTANCE OF CONTEXT, OKAY? [01:14:44.93] NOW, SO NOW I'VE GIVEN YOU SOME [01:14:48.17] BACKGROUND ON DECISION-MAKING [01:14:49.57] CAPACITY, WHAT IT IS, HOW IT [01:14:51.03] AFFECTS PEOPLE WITH DIFFERENT [01:14:52.97] DIAGNOSES. [01:14:53.27] LET'S NOW TALK ABOUT REGULATIONS [01:14:56.87] AND HOW WE CAN DO RESEARCH WITH [01:14:58.53] PEOPLE WHO ARE IMPAIRED. [01:15:01.47] RIGHT? [01:15:01.70] WHO WILL NOT BE ABLE TO MAKE [01:15:03.30] THEIR OWN DECISIONS AND GIVE [01:15:04.27] THEIR OWN CONSENT. [01:15:05.23] HOW DO WE DO THAT? [01:15:07.97] OKAY. [01:15:08.30] FEDERAL REGULATIONS CLEARLY [01:15:09.40] ALLOW IT IN THEORY, RIGHT, [01:15:12.13] BECAUSE THEY HAVE THIS WONDERFUL [01:15:13.33] TERM CALLED LEGALLY AUTHORIZED [01:15:15.83] REPRESENTATIVE, LAR. [01:15:16.77] WE THROW THAT TERM AROUND LIKE [01:15:18.10] WE KNOW WHAT WE'RE TALKING [01:15:19.47] ABOUT, BUT IT'S VERY -- I DON'T [01:15:21.47] KNOW, IT JUST MEANS THAT THE [01:15:23.60] REGULATIONS CAME UP WITH THIS [01:15:25.50] TERM AND THEY'RE LEGALLY [01:15:27.50] AUTHORIZED, BUT HERE IS THE [01:15:29.83] THING, THE FEDERAL REGULATION [01:15:33.43] SAYS, WELL, YOU KNOW, THE WAY WE [01:15:35.30] DEFINE IT IS THE WAY THE LOCAL [01:15:37.47] PEOPLE DEFINE IT. [01:15:40.90] OKAY? [01:15:41.43] UNFORTUNATELY, VERY FEW STATES [01:15:45.03] ACTUALLY HAVE DEFINED THIS, AS [01:15:47.27] WE'LL SEE. [01:15:49.27] SO OHRP GUIDANCE TURNS ON STATE [01:15:51.70] AND LOCAL LAWS. [01:15:54.30] NOW, CALIFORNIA, NEW JERSEY, [01:15:55.77] VIRGINIA, THERE MIGHT BE ONE [01:15:56.77] OTHER STATE SINCE THEN, SO I [01:15:59.47] MADE THIS SLIDE, THAT HAVE [01:16:00.70] MODERN LAWS. [01:16:01.23] WHAT DO I MEAN BY MODERN LAWS? [01:16:03.03] WHEN YOU READ THE TEXT RG YOU [01:16:05.27] REALIZE CLEARLY THE PEOPLE WHO [01:16:06.70] WROTE THIS HAVE READ THE COMMON [01:16:08.13] RULE, YOU KNOW WHAT THE COMMON [01:16:09.00] RULE IS, RIGHT? [01:16:11.27] OKAY. [01:16:11.50] AND THEY HAVE SOME SENSE OF THE [01:16:14.53] CONTEXT OF HOW WE CURRENTLY [01:16:18.53] REGULATE RESEARCH, AS CONTRASTED [01:16:21.20] TO SOME OF THE LAWS THAT MAY BE [01:16:22.47] RELEVANT THAT WERE WRITTEN IN 19 [01:16:26.27] MAYBE 50'S, 60'S, THAT WERE AN [01:16:28.60] ATTEMPT TO REGULATE, LET'S SAY, [01:16:30.73] PSYCHO SURGERY AND THINGS LIKE [01:16:31.73] THIS, SO IT DOESN'T HAVE QUITE [01:16:33.37] THE MODERN LANGUAGE AND CONCEPTS [01:16:37.80] SOME STATES LIKE MARYLAND [01:16:39.47] ATTORNEY GENERAL HAS A STATEMENT [01:16:40.50] THAT PROVIDES SOME GUIDANCE, BUT [01:16:43.37] IN MOST STATES IT'S KIND OF, [01:16:46.30] WELL, YOU KNOW, CALL YOUR [01:16:48.03] NEAREST LAWYER WHO CAN HELP YOU [01:16:49.87] TO GET THROUGH THIS. [01:16:54.70] NOW, SINCE THE DAYS, THE FIRST [01:16:58.83] TWO SLIDES I SHOWED YOU, SINCE [01:17:00.13] THE DAYS OF DR. BEECHER AND THE [01:17:04.37] VARIOUS COMMISSIONS, WHAT'S [01:17:05.23] HAPPENED IS THAT THERE'S BEEN [01:17:06.63] ONE MAJOR ADVANCE IN THE ETHICS [01:17:08.87] OF RESEARCH INVOLVING PEOPLE WHO [01:17:10.37] CAN'T CONSENT, AND IT'S THE [01:17:12.47] FOLLOWING, INVOLVING THOSE [01:17:13.67] LACKING DECISION-MAKING CAPACITY [01:17:14.47] OR AT RISK OF IT, THAT PROPOSAL [01:17:20.47] INVOLVING THOSE PEOPLE HAS TO BE [01:17:21.87] JUSTIFIED, YOU HAVE TO HAVE A [01:17:22.67] REASON FOR DOING IT. [01:17:23.40] WHAT WAS THE REASON FOR [01:17:25.50] INVOLVING THEM IN THE [01:17:29.03] EXPERIMENTS THAT DR. BEECHER [01:17:32.27] DESCRIBES? [01:17:32.57] THEY WERE CONVENIENT SAMPLES, [01:17:33.53] RIGHT? [01:17:33.73] HERE THEY ARE, THEY'RE NOT [01:17:35.43] COMPLAINING, THEY'RE EASY [01:17:37.87] ACCESS, YOU CAN DO -- I MEAN, [01:17:39.77] THEY WERE TRULY HUMAN GUINEA [01:17:41.40] PIGS. [01:17:41.83] IT'S NOT BECAUSE THEY HAD [01:17:45.87] DEMENTIA THAT THEY WERE [01:17:48.40] EXCELLENT SUBJECTS TO TEST, YOU [01:17:50.47] KNOW, SPREAD OF CANCER, LET'S [01:17:52.87] SAY. [01:17:53.07] WHAT DOES DEMENTIA HAVE TO DO [01:17:54.57] WITH CANCER, RIGHT? [01:17:55.70] IT DOESN'T. [01:18:00.90] SO SINCE THEN THESE ARE THE [01:18:02.17] RULES WE PLAY BY. [01:18:03.40] RESEARCH CAN'T BE DONE WITHOUT [01:18:04.67] THEM. [01:18:04.90] IN OTHER WORDS, YOU CAN ONLY [01:18:06.00] PROPOSE TO DO THAT RESEARCH [01:18:06.97] INVOLVING THOSE PEOPLE IF YOU [01:18:08.03] CAN PROVE TO THE IRB THAT I HAVE [01:18:11.77] TO USE THEM TO DO THIS, [01:18:12.97] OTHERWISE WE CAN'T ACTUALLY DO [01:18:14.77] THE SCIENCE. [01:18:16.67] SECOND, RESEARCH USUALLY IS [01:18:18.53] FOCUSED ON THE DISORDER CAUSING [01:18:21.90] THE INCAPACITY. [01:18:22.43] SO IT'S BECAUSE WE'RE TRYING TO [01:18:23.67] FIND A CURE FOR ALZHEIMER'S THAT [01:18:25.27] WE HAVE TO INVOLVE PEOPLE WITH [01:18:27.33] ALZHEIMER'S. [01:18:27.63] AND WE NEED TO BE CERTAIN THAT [01:18:28.87] THEY HAVE ALZHEIMER'S. [01:18:30.50] THAT'S WHY WE HAVE TO DO THAT [01:18:32.13] AFTER THEY'RE FULLY DIAGNOSED, [01:18:34.13] AND AFTER THEY'RE FULLY [01:18:35.93] DIAGNOSED, AS YOU SAW FROM THE [01:18:37.27] NUMBERS, MANY OF THEM WILL NOT [01:18:38.37] BE ABLE TO CONSENT. [01:18:40.70] MOST. [01:18:40.93] SO WE HAVE TO INVOLVE THEM. [01:18:44.67] NOW, THERE IS SOME DEBATE ABOUT [01:18:46.40] WHETHER THIS SHOULD BE SO STRICT [01:18:49.00] THAT IF THE PERSON HAS IMPAIRED [01:18:53.03] CAPACITY BUT THEY COULD BENEFIT [01:18:55.00] FROM SOME RESEARCH, WHETHER THEY [01:18:56.67] SHOULD BE EXCLUDED FROM THAT [01:18:59.47] RESEARCH, AND SO I'M NOT GOING [01:19:00.93] TO GO INTO THAT DETAIL, BUT I [01:19:02.57] JUST WANTED TO MENTION THAT [01:19:03.77] BECAUSE THAT'S ANOTHER WRINKLE [01:19:06.57] ON THIS TOPIC. [01:19:08.53] THE HHS, SECRETARY'S ADVISORY [01:19:12.47] COMMITTEE OR SACHARP HAS STATED [01:19:16.03] AS BEST, THE FIELD IS CHARACTER [01:19:17.70] IEMGZED BY A PATCHWORK OF IRB [01:19:19.80] POLICIES AND RESEARCH PRACTICES, [01:19:21.37] AND THEIR 2009 REPORT, WHICH I [01:19:23.77] THINK IS REALLY VERY GOOD, SO IF [01:19:26.13] YOU WANT TO READ, I THINK ONE OF [01:19:31.57] THE BEST INFORMED AND THOUGHT. [01:19:33.37] RECOMMENDATIONS ABOUT HOW YOU [01:19:34.50] MIGHT ACTUALLY ADDRESS THIS [01:19:38.77] ISSUE FROM IRB'S PERSPECTIVE, I [01:19:40.93] WOULD HIGHLY RECOMMEND THAT YOU [01:19:41.70] LOOK AT THIS DOCUMENT. [01:19:43.13] GUK TO THEIR WEBSITE AND LOOK AT [01:19:48.00] IT. [01:19:52.37] OKAY. [01:19:53.30] SO NEXT SECTION IS WHO SHOULD [01:19:54.70] GIVE PERMISSION. [01:19:55.47] SO WE'VE AGREED THAT YES, THEE [01:19:57.37] RED LIGHT CLI WE CAN INVOLVE [01:20:01.47] THESE FOLKS IN RESEARCH USING AN [01:20:04.03] LAR. [01:20:04.23] SO WHO SHOULD THEY BE? [01:20:06.30] THIS IS THE LAW. [01:20:12.70] VARIOUS OPTIONS. [01:20:14.00] LEGAL GUARDIAN, APPOINTED BY A [01:20:15.73] JUDGE. [01:20:19.80] NOW, WHAT'S NICE ABOUT THIS IS [01:20:22.17] THE LAWYERS LOVE HAVING A LEGAL [01:20:24.13] GUARDIAN BECAUSE IT'S LEGALLY [01:20:25.27] CLEAR, RIGHT? [01:20:25.80] THEY HAVE LEGAL AUTHORITY, [01:20:27.13] ESPECIALLY IF SOMEBODY ALREADY [01:20:28.17] HAS PROVIDED SOME LEGAL GUIDANCE [01:20:29.70] THAT THIS KIND OF LEGAL GUARDIAN [01:20:31.30] CAN GIVE CONSENT TO RESEARCH. [01:20:34.87] IF THAT'S DETERMINED, IT'S VERY [01:20:35.80] WELL CLEAR. [01:20:36.33] FROM AN ETHICAL POINT OF VIEW, [01:20:39.23] IT'S, RATHER, MORE IFFY BECAUSE [01:20:41.30] LEGAL GUARDIANS DON'T HAVE TO BE [01:20:42.57] THE PERCH WHO KNOWS THE PATIENT [01:20:44.43] THE -- DON'T HAVE TO BE THE [01:20:45.53] PERSON WHO KNOWS THE PATIENT THE [01:20:46.73] BEST, RIGHT? [01:20:48.17] IN MANY STATES LEGAL GUARDIANS [01:20:50.07] ARE LAWYERS WHO SIGN UP TO BE ON [01:20:52.50] THE GUARDIAN LIST AND THEY GET [01:20:53.80] PAID TO BE A GUARDIAN, TO BE THE [01:20:58.70] REPRESENTATIVE FOR THE PERSON [01:20:59.40] WHO CAN'T MAKE THEIR OWN [01:21:01.50] DECISIONS. [01:21:01.77] SO THERE'S NO INTRINSIC [01:21:04.93] CONNECTION TO THAT PERSON'S [01:21:09.37] PAST, THEIR VALUES, TO THE [01:21:10.40] PERSON BEING THE GUARDIAN. [01:21:14.63] SO LEGAL PROK TORS IS WHERE THE [01:21:17.23] PATIENT HAS SAID I WANT THIS [01:21:19.63] PERSON MAKING DECISIONS ABOUT [01:21:20.87] ME, EVIDENCE OF THAT IS THROUGH [01:21:22.83] THIS FORM, DURABLE POWER OF [01:21:25.43] ATTORNEY. [01:21:26.30] NOW, THIS IS GOOD BECAUSE THE [01:21:29.90] PERSON IS SUBJECT TO THEIR OWN [01:21:31.43] CHOICE, BUT USUALLY THESE ARE [01:21:32.80] FOR HEALTHCARE DECISIONS SO YOU [01:21:33.60] HAVE TO KIND OF EXTRAPOLATE TO [01:21:35.20] THE RESEARCH DECISION. [01:21:38.30] I'M NOT GOING TO GO INTO DETAIL [01:21:39.93] ABOUT HOW THE OHRP KIND OF GIVES [01:21:46.50] CAN GUIDANCE ABOUT WHAT KIND OF [01:21:48.27] RESEARCH YOU CAN DO UNDER THAT, [01:21:49.87] WITH THE UNDERSTANDING THERE ARE [01:21:52.93] PROCEDURES THAT ARE SIMILAR TO [01:21:54.47] TREATMENT WHERE THEY CAN DO [01:21:55.17] THAT. [01:21:55.43] BUT THAT'S THE BASIC IDEA. [01:21:57.07] THIRD CATEGORY SLT MOST RELEVANT [01:21:59.77] PRACTICALLY SPEAKING, RIGHT, [01:22:01.60] BECAUSE MANY PEOPLE DON'T FILL [01:22:04.03] OUT HEALTHCARE PROXIES EVEN AND [01:22:11.93] VERY FEW PEOPLE HAVE LEGAL [01:22:14.87] GUARDIANS, SO THE FACT OF FAMILY [01:22:16.63] MEETING, YOUR PARENTS, SIBLINGS, [01:22:18.27] WHOEVER, YOUR SPOUSE. [01:22:21.07] NOW, ALMOST EVERY STATE ACTUALLY [01:22:23.80] HAS A SURROGATE DECISION-MAKING [01:22:26.30] LAW, MEANING IN CASE THESE DON'T [01:22:29.57] EXIST, THEY AUTHORIZE FAMILY [01:22:33.37] MEMBERS TO MAKE SURROGATE [01:22:34.43] DECISIONS FOR HEALTHCARE AND [01:22:35.17] THEY GIVE A HIERARCHY. [01:22:36.97] SO THAT'S THE KIND OF THING [01:22:38.27] WE'RE TALKING ABOUT. [01:22:44.40] THIS REFLECTS THE REALITY OF [01:22:47.10] MOST FAMILIES, BUT IT IS NOT [01:22:48.73] CLEAR, BECAUSE THERE ARE PEOPLE [01:22:51.57] WHO IF THEY WERE ASKED TO [01:22:53.43] DECIDE, THEY WOULD SAY, OH, I'M [01:22:55.03] NOT GOING TO MAKE MY HUSBAND A [01:22:57.47] DPOA, HE'S A BASKET CASES, HE [01:22:59.10] GETS SO EMOTIONAL, HE CAN'T MAKE [01:23:00.90] DECISIONS, I'LL ASK MY DAUGHTER [01:23:01.87] TO DO T THEY DO THAT. [01:23:02.93] IT HAPPENS. [01:23:05.63] BUT BY LAW YOU WOULD STILL HAVE [01:23:06.87] TO GO TO THE HUSBAND OVER THE [01:23:08.37] DAUGHTER, RIGHT? [01:23:09.93] BECAUSE THAT'S THE USUAL [01:23:15.37] HIERARCHY. [01:23:16.37] THEN THERE'S THE LAST CONCEPT OF [01:23:18.07] A RESEARCH PROXY. [01:23:18.93] OF COURSE, NOBODY FILLS OUT A [01:23:20.97] RESEARCH ADVANCED DIRECTIVE, [01:23:22.50] RIGHT? [01:23:22.70] HOW MANY PEOPLE HAVE A RESEARCH [01:23:23.70] ADVANCED DIRECTIVE? [01:23:24.63] [LAUGHTER] [01:23:25.37] OKAY. [01:23:25.70] EXCEPT FOR CHRISTINE GRADY WHO [01:23:28.93] IS A TRUE OUTLIER. [01:23:32.87] [LAUGHTER] [01:23:34.70] >> Scott Kim: HOWEVERAS YOU'LL [01:23:35.43] SEE, THERE IS THIS CONCEPT OF A [01:23:38.17] CONCURRENT PROXY, NOT ADVANCED [01:23:40.20] BUT CONCURRENT, MEANING AT THIS [01:23:44.50] POINT I CAN APPOINT SOMEBODY TO [01:23:47.17] BE MY PROXY EVEN THOUGH, HERE IS [01:23:51.13] THE TRICKY CONCEPT, I MIGHT HAVE [01:23:54.27] MILD DEMENTIA, I MIGHT NOT BE [01:23:56.10] ABLE TO UNDERSTAND A 15-PAGE [01:23:59.17] CONSENT FORM, ACTUAL THEY'RE [01:24:01.00] LIKE 20 PAGES, BUT I DO KNOW [01:24:03.03] WHAT RESEARCH IS, I DO KNOW WHAT [01:24:06.60] RISK IS AND I KNOW MY WIFE AND [01:24:08.60] SHE'S GOING TO DO THIS FOR [01:24:12.00] ME, OKAY? [01:24:12.63] SO YOU'LL SEAL WE'VE DONE SOME [01:24:14.57] RESEARCH SHOWING THAT, THAT [01:24:15.97] PEOPLE CAN RETAIN THAT ABILITY [01:24:18.17] HAD. [01:24:20.43] OKAY? [01:24:20.63] THE RELIGIOUS IS INTERESTING, [01:24:22.27] THIS IS THEIR HIERARCHY THAT [01:24:24.00] THEY RECOMMEND, SO AS PER STATE [01:24:25.63] AND LOCAL LAW, DPOA, NOTICE HOW [01:24:29.00] THEY PUT THIS ABOVE LEGAL [01:24:31.67] GUARDIAN, RIGHT, PRESUMABLY THE [01:24:34.17] RATIONALE FOR THAT IS THEY GET [01:24:35.60] TO APPOINT THAT PERSON, WHEREAS [01:24:37.23] LEGAL GUARDIAN, YOU KNOW, WHERE [01:24:38.77] DOES THAT COME FROM? [01:24:40.33] THESE ARE THE MORE RELEVANT [01:24:42.67] CASES, 4, 5 AND 6, PRACTICALLY [01:24:46.90] SPEAKING. [01:24:47.40] OKAY? [01:24:47.60] SO WHAT DO PEOPLE THINK? [01:24:49.33] AM I HAVE A FEW SLIDES OF DATA [01:24:51.23] THAT WE'VE GENERATED OVER THE [01:24:53.43] YEARS IN VARIOUS TYPES OF [01:24:54.90] STUDIES AND I THINK THESE ARE [01:24:56.10] IMPORTANT TO KNOW BECAUSE WE'RE [01:24:57.33] NOT TALKING ABOUT, YOU KNOW, [01:24:59.57] REGULATIONS GOING AGAINST WHAT [01:25:00.70] PEOPLE WOULD REALLY WANT. [01:25:02.67] I MEAN, MOST PEOPLE, ONCE THEY [01:25:04.67] UNDERSTAND THE SITUATION, REALLY [01:25:07.47] UNDERSTAND THAT THIS IS [01:25:08.47] NECESSARY AND SO FORTH. [01:25:10.90] SO THIS SHOULDN'T BE TOO [01:25:12.47] SURPRISING TO YOU. [01:25:13.03] SO HERE THE QUESTION IS IF [01:25:14.90] PATIENTS CAN'T MAKE THEIR OWN [01:25:17.10] DECISIONS ABOUT BEING IN THESE [01:25:18.97] TYPES OF -- INVOLVING THESE KIND [01:25:20.57] OF PROCEDURES, STUDIES, SHOULD [01:25:22.90] OUR SOCIETY ALLOW THEIR FAMILIES [01:25:24.63] TO MAKE THE DECISION IN THEIR [01:25:27.93] PLACE? [01:25:29.57] DEFINITELY YES, PROBABLY YES, I [01:25:32.53] COMBINED THOSE INTO ONE NUMBER [01:25:33.67] HERE. [01:25:33.90] WHAT YOU GET IS THAT FOR A STUDY [01:25:35.90] THAT'S NONBENEFICIAL STUDY, JUST [01:25:41.67] DOING A NUMBER, MAJORITY SAY [01:25:43.67] YES, THIS IS A NATIONALLY [01:25:45.90] REPRESENTATIVE SAMPLE OF 12, [01:25:48.43] 1300 ADULTS, AGE 50 OR OLD, THIS [01:25:52.37] IS A GOOD EXAMPLE OF U.S. [01:25:54.73] ADULTS. [01:25:54.97] DRUG RCT, 83%. [01:25:57.60] VACCINE RCT, THIS WAS BASED ON [01:25:59.67] AN OLD ALZHEIMER'S DISEASE [01:26:01.60] VACCINE TRIAL AND EVEN A [01:26:03.37] NEUROSURGICAL GENE TRANSFER [01:26:04.90] STUDY OVER TWO-THIRDS THINK THAT [01:26:08.20] FAMILIES SHOULD BE ALLOWED TO [01:26:09.33] PROVIDE CONSENT OR MAKE THAT [01:26:15.57] DECISION. [01:26:15.83] THIS IS AFTER -- NOW, THE WAY WE [01:26:19.73] DID THIS STUDY IS IN 80% OF THE [01:26:22.70] CASES WE CALL PEOPLE, IN 20% WE [01:26:24.90] HAVE FACE TO FACE INTERVIEWS. [01:26:29.87] WELL, YOU CAN'T EXPLAIN A WHOLE [01:26:31.17] LOT BECAUSE THE WHOLE THING TOOK [01:26:32.47] MAYBE FOUR MINUTES. [01:26:33.33] THIS IS PART OF A MUCH LARGER [01:26:35.53] SURVEY. [01:26:35.77] SO I MEAN, HOW VALID IS PEOPLE'S [01:26:37.90] OPINION ABOUT THESE THINGS? [01:26:38.90] YOU WOULD LIKE TO GET THEIR [01:26:40.37] OPINIONS BASED ON HAVING THOUGHT [01:26:42.53] ABOUT THIS MORE DEEPLY, RIGHT? [01:26:44.13] SO WHAT WE DID WAS WE HAD THIS [01:26:49.80] PROCESS CALLED DEMOCRATIC [01:26:52.17] DELIBERATION, WHICH IS I CALL IT [01:26:57.00] MY -- SORT OF THE WEDDING [01:26:58.83] BANQUET RESEARCH BECAUSE WHAT WE [01:26:59.73] DO IS WE ACTUALLY RENT OUT THESE [01:27:02.17] WEDDING BANQUET ROOMS AND HOTELS [01:27:05.33] WITH THOSE BIG TABLES WHERE YOU [01:27:07.33] CAN COMFORTABLY SEAT LIKE 7, 8 [01:27:09.90] PEOPLE, AND WE BRING THEM IN A [01:27:11.43] HUGE ROOM, WE SPEND ALL DAY WITH [01:27:13.93] EXPERTS TALKING ABOUT THE NEED [01:27:15.97] TO DO RESEARCH AND AN ETHICS DID [01:27:21.97] RESEARCHER SAYING THERE HAVE [01:27:22.73] BEEN ALL THESE ABUSES, THAT'S [01:27:24.27] WHY WE HAVE THESE PROTECTION [01:27:25.57] SYSTEMS, THEY WALK AROUND [01:27:26.90] TOGETHER, PEOPLE ASK QUESTIONS, [01:27:28.20] EITHER SIDE CAN ANSWER QUESTIONS [01:27:29.23] AND SO FORTH, WE SPENT A WHOLE [01:27:32.10] DAY, THEN THERE ARE MULTIPLE [01:27:33.73] SMALL GROUP DISCUSSIONS AND SO [01:27:34.60] FORTH. [01:27:34.93] SO WHEN YOU SPEND AN ENTIRE DAY [01:27:36.13] LIKE THAT, THESE PEOPLE ARE [01:27:38.33] PRETTY EDUCATED AND THEY'VE [01:27:39.33] HEARD OTHER PEOPLE'S VIEWS ABOUT [01:27:41.37] THIS. [01:27:41.57] SO AFTER YOU DO THAT, THIS IS [01:27:43.03] WHAT YOU SEE. [01:27:44.97] BEFORE, AS YOU CAN SEE, I MEAN, [01:27:47.27] MOST PEOPLE ARE FOR ALLOWING [01:27:51.60] FAMILY SURROGATES IN THE FIRST [01:27:53.03] PLACE. [01:27:53.57] YOU'LL SEE THIS, FOR LP STUDY, [01:27:55.53] HERE THE NUMBERS ARE A LITTLE [01:27:56.47] HIGHER THAN THE LAST SLIDE, 84%, [01:27:58.57] BUT NOTICE THE CHANGE, 33% SAID [01:28:01.73] DEFINITELY ALLOW BEFORE THE [01:28:03.93] DELIBERATION DAY. [01:28:04.87] AFTER DELIBERATION, 76% SAY YES, [01:28:08.40] AND THE ACTUAL TOTALS NUMBER [01:28:09.67] GOES UP TOO, AND YOU CAN SEE [01:28:11.73] THIS PATTERN, 38 TO 76, 19 TO [01:28:15.77] 51, 17 TO 41. [01:28:17.40] BASICALLY WHEN PEOPLE SPEND THE [01:28:20.53] DAY HEARING FROM EXPERTS IN [01:28:23.33] RESEARCH AS WELL AS ETHICS AND [01:28:24.90] TALK ABOUT IT WITH THEIR PEERS, [01:28:26.97] THESE ARE RANDOMLY SELECTED [01:28:29.47] PEOPLE AROUND AN AR BORKS [01:28:32.60] MICHIGAN -- ANN ARBOR, MICHIGAN, [01:28:33.77] IT MIGHT BE A LITTLE ODD, [01:28:34.83] MICHIGAN YOU MIGHT THINK IS -- [01:28:36.20] WELL, IT'S FAIRLY [01:28:37.30] REPRESENTATIVE. [01:28:37.67] THIS IS WHAT THEY SAY IN TERMS [01:28:38.97] OF WHEN WE ANALYZE THE TEXT FROM [01:28:42.43] THEIR DISCUSSIONS. [01:28:44.73] OKAY? [01:28:46.53] PARTICIPANT A. [01:28:47.23] BUT IF THE ANSWER IS NO, WE [01:28:48.77] CAN'T ALLOW FAMILY MEMBERS TO DO [01:28:50.77] THIS, THAT SURROGATES CAN'T GIVE [01:28:53.47] CONSENT, THEN THERE IS NO HOPE [01:28:54.87] FOR EVER GETTING ANYWHERE, SO [01:28:56.17] THE ANSWER HAS TO BE IN MY MIND [01:28:58.13] YES. [01:28:58.37] BY VOTING NAY AGAINST SURROGATE [01:29:01.27] EMPOWERMENT, WHAT YOU'RE [01:29:02.03] ESSENTIALLY DOING IS VOTING NO [01:29:03.33] TO EVERY OTHER FAMILY. [01:29:06.23] IT'S INTERESTING. [01:29:06.70] THIS PERSON HAS INSIGHT THAT [01:29:08.03] WE'RE NOT JUST TALKING ABOUT [01:29:09.57] WHAT I WANT. [01:29:10.17] THIS IS WITH -- THIS IS ABOUT [01:29:13.90] SOCIAL POLICY AND WE REALLY HAVE [01:29:15.03] TO TAKE THAT PERSPECTIVE, AND [01:29:16.40] YOU'RE PUTTING YOURSELF IN THE [01:29:17.17] POSITION OF IMPACTING EVERY [01:29:18.73] FAMILY WHO HAS AN ALZHEIMER'S [01:29:20.43] PATIENT. [01:29:20.67] SO IT SEEMS AS THOUGH WE ALMOST [01:29:22.23] HAVE NO CHOICE BUT TO HAVE SOME [01:29:24.03] FORM OF SURROGATE CONSENT AND [01:29:25.90] THE CHALLENGE IS HOW DO WE MAKE [01:29:30.07] IT WORK? [01:29:30.67] HOW DO WE BUILD PROTECTIONS FOR [01:29:32.53] THE ALZHEIMER'S VICTIM, THE [01:29:34.30] PATIENT? [01:29:35.33] THIS SHOWS A PATTERN THAT I'VE [01:29:36.80] NOTICED. [01:29:37.03] I'VE DONE A LOT MUCH WORK ON [01:29:39.20] CONTROVERSIAL ETHICAL ISSUES, [01:29:40.77] AND WE TAKE IT TO THE PUBLIC, [01:29:42.10] AND WE SPEND A WHOLE DAY TALKING [01:29:43.57] ABOUT THESE TOPICS. [01:29:44.57] IT COULD BE CONSENT FOR BROAD [01:29:46.87] CONSENT FOR BIOBANKS, IT COULD [01:29:48.27] BE THIS, IT COULD BE ANY TOPIC. [01:29:50.17] WHAT I FIND IS THAT THE PUBLIC [01:29:53.67] QUICKLY GETS TO THE STATE OF THE [01:29:56.57] LITERATURE IN THE FIELD WELL [01:29:58.70] WITHIN A DAY. [01:29:59.50] THEY KNOW WHAT THE ISSUES ARE, [01:30:01.17] THEY GET THERE, AND AS YOU CAN [01:30:02.93] SEE, THEY SUM IT UP VERY WELL. [01:30:06.73] SO I THINK THAT THE DATA FROM A [01:30:08.50] STUDY LIKE THIS GIVES A PRETTY [01:30:10.47] GOOD FEEL FOR WHAT ARE ARE [01:30:14.73] CONSIDERED MORAL JUDGMENT OF OUR [01:30:16.57] FELLOW CITIZENS WOULD BE. [01:30:17.90] NOW, HOW MUCH FREEDOM OR LEEWAY [01:30:19.23] WOULD YOU GIVE YOUR FAMILY IN [01:30:21.03] THIS IS ANOTHER QUESTION WE [01:30:22.23] ASKED. [01:30:22.50] WE FIRST ASKED THEM, HERE STD [01:30:24.23] RESEARCH STUDY. [01:30:27.23] WOULD YOU IF YOU EVER BECAME [01:30:31.20] INCAPACITATED CONSIDER TO BE A [01:30:32.43] VOLUNTEER IN THOSE STUDIES, AND [01:30:33.87] MOST PEOPLE SAID YES, YEAH, I [01:30:35.60] WOULD VOLUNTEER. [01:30:41.30] THEN WE ASKED THEM, OKAY, HOW [01:30:43.77] MUCH LEEWAY WOULD YOU GIVE YOUR [01:30:44.97] FAMILY MEMBER IN THE FUTURE TO [01:30:45.90] GO GEFNS WHAT YOU SAID? [01:30:47.80] -- TO GO AGAINST WHAT YOU SAID? [01:30:49.03] IF YOU SAID YES, THEY'LL SAY NO, [01:30:51.23] IF YOU SAID NO, THEY'LL SAY YES? [01:30:53.17] WHAT'S REALLY INTERESTING IS [01:30:55.53] THIS. [01:30:55.73] THIS IS A NATIONAL SURVEY. [01:30:58.77] ONLY A MINORITY SAY NO LEEWAY. [01:31:06.77] A SIMILAR NUMBER SAY SOME [01:31:10.20] LEEWAY, AND ABOUT A FIFTH SAY [01:31:11.83] COMPLETE LEEWAY. [01:31:12.53] AS YOU MIGHT IMAGINE, MOST [01:31:14.13] PEOPLE WHO WANT LEEWAY ARE [01:31:15.33] PEOPLE WHO SAID YES AND THEY CAN [01:31:16.43] SAY NO IF THEY WANT TO, BUT [01:31:17.60] THERE IS A SUBSTANTIAL NUMBER OF [01:31:18.63] PEOPLE WHO SAID NO WHO SAID YES [01:31:22.13] THEY CAN SAY YES AT THE TIME [01:31:23.57] BECAUSE THEY'LL KNOW MORE, [01:31:26.20] RIGHT, AT THE TIME, THEY MIGHT [01:31:27.03] HAVE OTHER DATA. [01:31:30.13] FOR THE DELIBERATION SESSIONS, [01:31:32.60] WHAT'S INTERESTING IS THAT AFTER [01:31:36.10] DELIBERATION, THE NUMBERS ARE [01:31:38.40] MUCH HIGHER. [01:31:40.67] MOST PEOPLE -- LOOK, THE POINT [01:31:42.50] OF THIS SLIDE IS THAT, YOU KNOW, [01:31:45.90] WHEN WE DO THESE KIND OF STUDY [01:31:49.77] SETS, I THINK THERE'S SOME KIND [01:31:51.70] OF UNIVERSE REALITY THAT DEPENDS [01:31:54.13] ON THE FUTURE ABOUT WHAT PEOPLE [01:31:55.30] WANT AND SO FORTH, WHEN YOU ASK [01:31:57.10] PEOPLE REALISTICALLY ABOUT, [01:31:58.67] WELL, YOU KNOW, YOU DON'T KNOW, [01:32:00.87] HOW MUCH WOULD YOU -- PEOPLE [01:32:02.47] ARE, IN MY VIEW, PRETTY WISE [01:32:03.93] ABOUT THE FACT THAT THEY DON'T [01:32:05.37] KNOW EVERYTHING RIGHT NOW AND [01:32:06.33] THEY'RE GOING TO HAVE TO RELY ON [01:32:07.77] OTHER PEOPLE. [01:32:12.33] OKAY. [01:32:15.27] PRESERVE ABILITIES OF INCAPACITY [01:32:17.47] OF PERSONS. [01:32:18.53] THIS IS TOPIC IS IMPORTANT [01:32:21.80] BECAUSE IN THEORY, A PERSON WHO [01:32:23.37] IS NOT CAPABLE OF GIVING CONSENT [01:32:28.20] TO RESEARCH COULD HAVE SOME [01:32:32.07] RETAINED ABILITIES THAT ARE [01:32:32.90] STILL ETHICALLY VERY RELEVANT. [01:32:34.63] THAT'S THE POINT. [01:32:35.67] AND A COUPLE OF THOSE COULD BE [01:32:37.30] THE FOLLOWING. [01:32:39.13] YEAH, YOU KNOW, IF I ASK THEM [01:32:40.63] ALL THESE QUESTIONS, THEY [01:32:41.73] PROBABLY COULDN'T GET ALL THE [01:32:43.50] RIGHT ANSWERS, BUT IF YOU ASK [01:32:45.47] THEM DO YOU WANT TO OR NOT WANT [01:32:46.97] TO AND THEN COMPARE THEIR [01:32:48.10] ANSWERS TO PEOPLE WHO ARE [01:32:50.80] NORMAL, HOW DO THEY COMPARE? [01:32:52.00] THAT'S ONE QUESTION. [01:32:52.87] THE OTHER IS, A PERSON WHO IS [01:32:55.27] INCAPABLE OF GIVING INFORMED [01:32:56.67] CONSENT, CAN THEY STILL APPOINT [01:32:57.90] A PROXY? [01:32:58.70] WHICH IS A POINT I MADE EARLIER. [01:33:01.77] WHEN YOU LOOK AT THAT, GENERALLY [01:33:04.07] PEOPLE EVEN WITH DEMENTIAS TEND [01:33:10.13] TO HAVE PREFERENCES THAT ARE [01:33:11.43] VERY SIMILAR TO PEOPLE WHO ARE [01:33:13.17] NORMAL. [01:33:13.40] IN OTHER WORDS, THEY MIGHT NOT [01:33:14.57] BE ABLE TO ARTICULATE ALL THE [01:33:16.53] IN'S AND OUT'S TO CONVINCE YOU [01:33:18.07] THAT THEY'RE COMPETENT, BUT IN [01:33:19.20] TERMS OF WHAT THEY WANT AND THE [01:33:22.53] RISK/BENEFIT, IT'S NOT THAT FAR [01:33:24.07] OFF. [01:33:24.40] OKAY. [01:33:24.60] THE OTHER POINT IS THIS. [01:33:28.60] SUBSTANTIAL NUMBER OF PEOPLE WHO [01:33:29.90] CAN'T GIVE THEIR OWN CONSENT FOR [01:33:32.27] CERTAIN TRIALS CAN STILL GIVE -- [01:33:35.07] CAN STILL APPOINT A PROXY. [01:33:37.40] IN OUR STUDY INVOLVING ABOUT 180 [01:33:40.33] PEOPLE WITH ALZHEIMER'S DISEASE, [01:33:43.33] 38% OF THOSE WHO ARE NOT ABLE TO [01:33:45.47] CONSENT TO A DRUG RCT AND 55% [01:33:49.73] WHO ARE NOT DEEMED TO BE CAPABLE [01:33:51.37] OF CONSENTING TO A NEUROSURGICAL [01:33:54.30] RCT WERE SEEN AS CAPABLE OF [01:33:56.53] APPOINTING A PROXY, AND THIS IS [01:33:58.10] ALL VALIDATED BY FIVE [01:34:02.07] PSYCHIATRISTS BEING TORTURED BY [01:34:03.53] ME LOOKING AT THESE VIDEOS FOR, [01:34:05.27] YOU KNOW, THREE YEARS AND GIVING [01:34:07.73] THEIR JUDGMENTS. [01:34:12.60] 92% OF PEOPLE WITH AD, MINI [01:34:14.70] MENTAL OF ABOUT 24 OR SO, HAD [01:34:17.43] CAPACITY OF APPOINTED RESEARCH [01:34:19.63] PROXY. [01:34:19.87] WHAT DOES THIS MEAN? [01:34:21.30] EVEN AFTER DIAGNOSIS, IT'S [01:34:22.80] POSSIBLE, UCIALGLY POSSIBLE TO [01:34:24.47] ACTUAL -- USUALLY POSSIBLE TO [01:34:26.97] ACTUALLY ASK THEM, OKAY, IT'S [01:34:28.40] GOING TO BE HARD FOR YOU TO [01:34:29.60] MANAGE THIS ON JUROR OWN, DO YOU [01:34:30.67] WANT TO APPOINT SOMEBODY WHO CAN [01:34:32.43] TAKE RESPONSIBILITY IF YOU [01:34:33.97] CAN'T? [01:34:34.60] SECOND, AS MUCH AS POSSIBLE, [01:34:36.13] EVEN IF PEOPLE HAD THE [01:34:39.40] DIAGNOSIS, OUR IMPULSE SHOULD BE [01:34:40.53] HOW DO WE STILL INVOLVE THIS [01:34:44.97] PERSON? [01:34:45.30] BECAUSE THEY HAVE ETHICALLY [01:34:46.33] RELEVANT THINGS TO SAY ABOUT [01:34:47.77] THEIR INVOLVEMENT. [01:34:52.63] OKAY? [01:34:52.83] I'M GOING ON RUSH -- I'M GOING [01:34:55.83] ON RUSH THROUGH THIS. [01:34:56.77] NOW WE'RE GOING TO TALK ABOUT [01:34:58.17] RISK BENEFIT LIMITS. [01:35:00.17] NOW, WE'VE TALKED ABOUT WHO CAN [01:35:02.77] CONSENT. [01:35:03.17] NOW WE'RE GOING TO TALK ABOUT [01:35:04.20] UNDER WHAT CONDITIONS. [01:35:09.20] THE OBVIOUS SOMEONE THE RISK. [01:35:10.07] THIS IS THE WAY MOST IRB'S LOOK [01:35:11.93] INTO THIS. [01:35:12.43] I'M NOT GOING TO GO INTO THIS [01:35:14.63] NOW BECAUSE IT WILL BE REFLECTED [01:35:15.80] IN OUR NIH POLICY. [01:35:22.73] ONE THING I WOULD SAY IS THIS, [01:35:24.20] THERE'S THIS CONCEPT CALLED [01:35:25.83] MINOR INCREASE OVER MINIMAL [01:35:27.83] RISK. [01:35:28.10] HOW MANY OF YOU HAVE HEARD A [01:35:30.47] LECTURE ON CHILDREN'S RESEARCH [01:35:32.33] REGULATIONS? [01:35:32.67] HAVE YOU HAD THAT ALREADY? [01:35:34.57] OKAY. [01:35:36.53] 407, 406. [01:35:39.10] OKAY. [01:35:39.90] IT'S THE ANALOGOUS ONE. [01:35:41.33] SO USUALLY THE PROBLEM IS THIS, [01:35:45.23] AND SACHRP POINTS IT OUT, VALID [01:35:52.20] VIESH VITALLY IMPORTANT C-C -- [01:36:02.33] YOU WOULD REALLY, REALLY HAMPER [01:36:03.77] IMPORTANT RESEARCH THAT NEEDS TO [01:36:04.47] BE DONE, THAT'S THEIR VIEW. [01:36:07.00] THEY THAT I AN EXCEPTIONAL [01:36:09.60] CIRCUMSTANCE IS MODERATE RISK OF [01:36:10.83] HARM OR DISCOMFORT WOULD BE OKAY [01:36:12.93] IF SAFEGUARDS ARE APPROPRIATE [01:36:18.77] AND IT'S REALLY POSHTD RESEARCH, [01:36:20.33] SOMEBODY DETERMINES THAT TO BE [01:36:21.07] THE CASE, THAT SORT OF REFLECTS [01:36:23.63] NIH'S POLICY TOO. [01:36:24.37] OTHER PROTECTIONS, IMPORTANCE OF [01:36:25.80] CONTEXT, I'M JUST GOING TO GO [01:36:27.87] THROUGH TWO QUICK SCENARIOS TO [01:36:28.93] GIVE YOU A FLAVOR FOR HOW TO [01:36:31.87] APPLY ALL THIS ABSTRACT STUFF [01:36:33.20] I'VE BEEN THROWING AT YOU AND [01:36:34.23] JUST THINK ABOUT AN ACTUAL [01:36:36.47] RESEARCH SUBJECT WHO MIGHT ENTER [01:36:37.57] A STUDY AND HOW DIFFERENT THEY [01:36:38.80] ARE DEPENNING ON THE CONTEXT, [01:36:43.77] OKAY? [01:36:45.50] IMAGINE MR. A WITH ALZHEIMER'S [01:36:47.37] CAN'T GIVE HIS OWN CONSENT, [01:36:53.27] FINANCIALLY STABLE, RESOURCES, [01:36:55.43] THEY CAN SEEK OUT THESE CLINICAL [01:36:59.43] TRIALS K NOFLY INTERVENTION, [01:37:01.13] IT'S BEEN TESTED IN [01:37:02.80] THOUSAND PEOPLE ALREADY WITH [01:37:04.00] ONLY MINOR ADVERSE EFFECTS SEEN, [01:37:05.50] THE GOAL IS TO SLOW DOWN THE [01:37:08.67] DISEASE, HE STRONGLY DESIRES TO [01:37:09.90] BE IN THE STUDY, HE HAS AN [01:37:12.50] ALTRUISTIC MOTIVE BUT ALSO FEELS [01:37:14.23] LIKE HEY, GIVEN THIS, WHY NOT? [01:37:17.07] THIS SPEAKS TO THE THERAPEUTIC [01:37:19.17] MISCONCEPTION QUESTION YOU HEARD [01:37:23.57] ABOUT. [01:37:24.67] THIS CONTEXT IS INTERESTING. [01:37:26.33] THIS IS NOT ATYPICAL OF PEOPLE [01:37:28.10] WHO ENTER ALZHEIMER'S TRIALS. [01:37:29.53] ONE OF THE PROBLEMS WITH [01:37:30.57] ALZHEIMER'S TRIALS IS IT TENDS [01:37:31.57] TO BE SOUGHT OUT BY PEOPLE OF [01:37:34.37] MEANS AND KNOWLEDGE WHO SEEK [01:37:36.80] THESE THINGS OUT. [01:37:37.83] NOW, COMPARE THAT TO THIS PERSON [01:37:40.67] MR. S WITH SCHIZOPHRENIA, MEETS [01:37:43.63] THRESHOLD FOR CAPACITY SO CAN IN [01:37:46.70] THEORY CONSENT FOR HIMSELF, [01:37:48.20] OKAY? [01:37:49.20] HOWEVER, HE'S SINGLE, ESTRANGED [01:37:50.93] FROM HIS FAMILY UNEMPLOYD [01:37:52.60] SOCIALLY ISOLATED, QUITE [01:37:55.77] POSSIBLY OF RACIAL AND ETHNIC [01:37:57.07] MINORITY ON TOP OF THAT. [01:37:59.47] THE RCT IS A COMPOUND THAT'S [01:38:01.93] ALREADY MARKETED, IT'S NOT A [01:38:03.23] NEWLY PARADIGM, DIFFERENT [01:38:05.27] FORM -- IT'S NOT A NEW PARADIGM, [01:38:06.93] DIFFERENT FORMULATION TO OPT [01:38:08.57] MIEPS EFFECT, FOR EXAMPLE, TO [01:38:12.37] INCREASE ADHERE EFNS TO THE [01:38:13.57] DRUG, DIFFERENT TYPE OF TRIAL, [01:38:15.87] MARKET CONSIDERATIONS ARE [01:38:16.53] PROBABLY THE REASON FOR DOING [01:38:17.73] THIS FROM A DRUG COMPANY'S POINT [01:38:19.03] OF VIEW. [01:38:19.70] IT'S NOT AS SEXY APPEARS THE [01:38:21.33] OTHER TRIAL -- AS THE OTHER [01:38:23.10] TRIAL, RIGHT? [01:38:23.97] AND THERE'S NO STRONG INCENTIVE [01:38:25.43] TO ENROLL. [01:38:26.07] NOW, EVEN THOUGH WE SAY THIS [01:38:28.20] PERSON MEET THE THRESHOLD, ALL [01:38:29.90] THESE THINGS INDICATE THAT, YOU [01:38:31.53] KNOW, WE HAVE TO REALLY WORRY [01:38:32.87] ABOUT HOW TO PROTECT THIS PERSON [01:38:34.33] TO MAKE SURE HE REALLY WANTS TO [01:38:35.73] BE IN THIS STUDY KNOWING ALL THE [01:38:38.10] FACTORS, RIGHT? [01:38:39.07] EVEN THOUGH THIS, THE FIRST CASE [01:38:41.83] OF MR. A, YOU KNOW, HE'S NOT [01:38:44.63] COMPETENT SO WE THINK OH, THIS [01:38:46.30] IS REALLY -- WELL, YOU KNOW, BUT [01:38:47.93] HIS SOCIAL CONTEXT IS MUCH [01:38:49.93] SAFER. [01:38:50.17] SO YOU HAVE TO UNDERSTAND THOSE [01:38:51.80] KIND OF CONTEXTS TO FIGURE OUT [01:38:54.57] HOW MUCH PROTECTIONS AND WHAT [01:38:55.63] KIND OF PROTECTIONS ARE [01:38:58.53] IMPORTANT. [01:39:00.27] AND THEY HAVE -- OKAY. [01:39:02.23] THESE ARE THE OTHER PROTECTIONS [01:39:04.23] THAT ARE RELEVANT. [01:39:06.60] FOR EXAMPLE, WELL DEFINED [01:39:08.23] CAPACITY ASSESSMENTS, RESPECT [01:39:10.00] FOR PRESERVED ABILITIES, I [01:39:11.73] MENTIONED, SUBJECT ADVOCATES, [01:39:12.77] SHOULD WE USE SUBJECT ADVOCATES. [01:39:14.63] FOR THE YOUNG MAN IN THE [01:39:16.40] SCHIZOPHRENIA TRIAL YOU MAY [01:39:17.60] CONSIDER THAT BECAUSE, WELL, HE [01:39:19.10] DOESN'T HAVE ANYBODY ELSE, [01:39:21.47] WHEREAS PERSON WITH ALWAYS [01:39:24.13] ALZHEIMER'S, THE CURRENT -- WITH [01:39:26.70] ALZHEIMER'S, THE CURRENT TERM, [01:39:28.57] HE HAS CHILDREN, HIS WIFE, AND [01:39:30.03] THESE ARE OTHER PROTECTIONS THAT [01:39:31.67] YOU COULD ADD TO THE STUDY. [01:39:36.40] OKAY. [01:39:36.70] I'M JUST GOING TO RUN THROUGH [01:39:37.80] THE NIH POLICY. [01:39:39.73] CAN I DO THAT? [01:39:40.80] >> YES. [01:39:46.53] >> Scott Kim: OKAY. [01:39:47.03] VERY BRIEF SUMMARY, BECAUSE IT'S [01:39:51.50] REALLY COMPLICATED AND THE JOKE [01:39:52.80] IN THE DEPARTMENT WHEN WE DO [01:39:56.03] CONSULTS IS THAT WE ALL HAVE TO [01:39:57.83] GO AND READ THE POLICY EVERY [01:39:59.13] TIME PEOPLE CALL US. [01:39:59.93] OF COURSE, WE'RE BETTER AT [01:40:02.07] READING IT BECAUSE WE'VE READ IT [01:40:04.50] A HUNDRED TIMES BEFORE, BUT [01:40:05.80] STILL. [01:40:06.33] OKAY. [01:40:06.57] I'M SORRY ABOUT ALL THIS STUFF. [01:40:08.10] I'VE NOW BECOME AN OFFICIAL [01:40:10.17] GOVERNMENT ZOMBIE AND I FEEL [01:40:11.70] COMFORTABLE WRITING ALL THESE [01:40:14.07] LITTLE LETTERS WITHOUT ASSUMING [01:40:15.47] YOU CAN UNDERSTAND IT. [01:40:18.23] SUCH A PROTOCOL THAT PROPOSED TO [01:40:21.50] INVOLVE PEOPLE WHO ARE IMPAIRED, [01:40:22.73] CAN'T GIVE THEIR OWN CONSENT, [01:40:24.70] MUST HAVE PRIOR IRB APPROVAL AND [01:40:26.63] YOU HAVE TO SPECIFY THESE [01:40:29.17] THINGS. [01:40:29.40] YOU HAVE TO JUSTIFY WHRL THEY [01:40:31.80] HAVE TO BE IN THE STUDY, YOU [01:40:33.00] HAVE TO DECIDE HOW YOU'RE GOING [01:40:34.77] TO ASSESS CAPACITY, WHO IS GOING [01:40:36.27] TO GIVE CONSENT AND HOW ARE YOU [01:40:37.47] GOING TO TELL THOSE PEOPLE WHO [01:40:38.93] ARE GOING TO GIVE CONSENT ARE [01:40:40.43] THE RIGHT PEOPLE, THE RISK LEVEL [01:40:42.37] AND THE PROS SPEBLGHT FOR [01:40:44.10] BENEFIT HAS TO BE SPECIFIED. [01:40:45.37] YOU HAVE TO MAKE PROVISIONS FOR [01:40:47.13] ASENT AND DISSENT AND THIS IS [01:40:48.57] SORT OF THE MINIMAL THING THAT [01:40:50.17] WE DO TO KEEP THE INCAPACITY OF [01:40:54.00] THE PERSON'S VOICE STILL [01:40:56.83] RELEVANT, RIGHT? [01:40:58.23] OKAY. [01:40:58.53] AND I THINK THIS COULD BE MORE, [01:41:00.93] BUT THERE IT IS. [01:41:02.07] AND ANY ADDITIONAL SAFEGUARDS. [01:41:04.97] SO POLICY VARIES BY RISK/BENEFIT [01:41:07.37] CATEGORY. [01:41:07.80] THERE'S THE MINIMAL RISK AND [01:41:09.57] THEN THERE IS CATEGORY OF [01:41:10.87] PROSPECT FOR DIRECT BENEFIT AND [01:41:12.23] IT DOESN'T MATTER WHAT THE RISKS [01:41:13.80] ARE THERE, ONCE YOU DETERMINE [01:41:16.10] THIS. [01:41:16.30] AND THEN THERE IS NO PROSPECT OF [01:41:18.27] DIRECT BENEFIT WITH NO GREATER [01:41:20.70] THAN MINOR INCREASE OR MINIMAL [01:41:25.63] RISK. [01:41:25.87] ALSO CAN A REQUIREMENT. [01:41:26.87] AND THEN THERE IS THE GREATER [01:41:28.73] THAN MINOR RISK OVER MINIMAL [01:41:30.20] RISK WHERE IT REQUIRES A SPECIAL [01:41:31.83] REVIEW. [01:41:32.07] IN OTHER WORDS, NO PROSPECT OF [01:41:35.07] BENEFIT GREATER THAN MINOR [01:41:36.63] INCREASE OVER BENEFIT, WE HAVE [01:41:38.07] TO SEND THAT TO THE NIH DEPUTY [01:41:41.23] DIRECTOR OF INTRAMURAL RESEARCH, [01:41:43.43] HE CONVENES A PANEL, AS FAR AS [01:41:46.30] I'M AWARE THERE'S ONLY BEEN ONE [01:41:48.47] OF THESE WHICH I SERVED ON, AND [01:41:52.43] THAT PANEL HAS TO DETERMINE THAT [01:41:54.30] HER THE RESEARCH IS VITALLY [01:41:57.63] IMPORTANT, CAN'T BE DONE WITHOUT [01:41:58.90] THOSE PEOPLE AND CAN'T BE DONE [01:42:00.83] WITH LESS RISK. [01:42:01.63] AND THIS IS THE LAST SLIDE. [01:42:04.33] IT DOES LIMIT ACCORDING TO THE [01:42:06.87] TYPE OF SURROGATE, OKAY? [01:42:08.37] IF THE PERSON HAS A DTA OR A [01:42:11.97] GUARDIAN, PRETTY MUCH AS LONG AS [01:42:13.03] ALL CONDITIONS AND PROPER REVIEW [01:42:14.53] IS DONE, IT IS ALLOWABLE, EVEN [01:42:16.33] THE HIGHEST RISK WITH SPECIAL [01:42:18.97] PANEL. [01:42:19.50] ALSO IF THE PERSON HAS ENOUGH [01:42:22.33] CAPACITY TO APPOINT A PROXY [01:42:25.57] CONCURRENTLY, OKAY, THEN IT'S [01:42:29.87] ALLOWABLE ASSUMING THE REVIEW [01:42:31.27] GOES WELL. [01:42:33.07] HOWEVER, IF ALL THEY HAVE IS A [01:42:36.03] FAMILY WITHOUT EITHER OF THIS, [01:42:37.93] THEN ONCE IT GETS OVER MINOR [01:42:41.40] INCREASE IN RISK OR MORE, IT'S [01:42:45.07] NOT ALLOWED. [01:42:46.20] OKAY? [01:42:46.40] SO THAT'S MY LAST SLIDE. [01:42:47.93] I CAN TAKE A FEW QUESTIONS, I [01:42:51.17] THINK. [01:42:52.47] [APPLAUSE] [01:42:58.37] >> QUESTIONS? [01:43:10.63] >> I SEE THAT YOU USE MINIMUM MY [01:43:13.93] MENTAL AS KIND OF A STANDARD -- [01:43:16.37] MINI MENTAL AS KIND OF A [01:43:17.53] STANDARD FOR ASSESSING CAFTD? [01:43:19.60] >> Scott Kim: NO, THAT'S NOT [01:43:20.20] WHAT I'M DOING. [01:43:20.67] >> OKAY. [01:43:21.30] WELL, I GUESS IN A PATIENT WHO [01:43:22.90] HAS EXPRESSIVE APHASIA, WHAT HOW [01:43:28.70] WOULD YOU EVALUATE THEIR ABILITY [01:43:30.10] TO ASSIGN A PROXY OR CONSENT? [01:43:35.43] >> Scott Kim: ANK YOU FOR [01:43:36.03] BRINGING THE MINI MENTAL ISSUE. [01:43:38.43] THAT IS JUST THERE TO GIVE YOU A [01:43:40.30] SENSE OF A ROUGH ESTIMATE OF [01:43:41.50] THEIR COGNITIVE ABILITY. [01:43:42.70] IT IS NOT MEANT TO JUSTIFY THEIR [01:43:47.50] STATUS OF CAPACITY OR NOT. [01:43:48.63] ALL THESE EVALUATIONS THAT [01:43:49.80] DETERMINE THEIR EXAFORT IS DONE [01:43:50.83] THROUGH A FUNCTIONAL SPECIFIC [01:43:54.70] INSTRUMENT AND THAT'S A GREAT [01:43:56.17] QUESTION. [01:43:56.43] I DON'T THINK MY SLIDES MADE [01:43:57.50] THAT CLEAR ENOUGH, SO I [01:43:58.70] APPRECIATE THAT. [01:44:03.07] YOUR QUESTION ABOUT PEOPLE WITH [01:44:05.20] EXPRESSIVE APHASIA, IT KIND OF [01:44:06.30] VARIES ON HOW DENSE IT IS AND [01:44:07.43] THE CLINICAL SITUATION. [01:44:12.43] IF THIS IS EXTREMELY DENSE AFAY [01:44:16.00] SHARKS IT'S DIFFICULT BECAUSE [01:44:16.90] THEY CAN'T EXPRESS THEMSELVES, [01:44:18.17] BUT AS YOU KNOW, I DON'T KNOW [01:44:19.27] WHAT YOUR BACKGROUND IS, BUT [01:44:20.37] PEOPLE HAVE -- IT'S NOT AN ALL [01:44:21.87] OR NOTHING THING, QUITE HONESTLY [01:44:26.97] CLINICALLY, SO YOU HAVE TO MAKE [01:44:28.07] DUE. [01:44:28.33] I'M NOT SURE IN THE RESEARCH [01:44:29.60] CONTEXT BECAUSE I'M NOT AWARE OF [01:44:31.50] RESEARCH THAT EXCLUSIVELY [01:44:32.97] TARGETS PEOPLE WITH EXPRESSIVE [01:44:36.20] APHASIA, IN ALZHEIMER'S OR OTHER [01:44:42.13] DEMENTIA PEOPLE COULD HAVE A [01:44:44.70] PROPORTIONALLY EFFECTIVE [01:44:45.73] LANGUAGE DIFFICULTY AND THAT [01:44:46.33] WOULD COME OUT IN THE FUNCTIONAL [01:44:47.77] ASSESSMENT AND THAT PERSON WOULD [01:44:49.17] BE SEEN AS NOT ABLE TO GIVE [01:44:50.60] THEIR OWN CONSENT IN THAT KIND [01:44:52.83] OF CONTEXT. [01:44:53.93] >> THANK YOU. [01:44:54.90] MY QUESTION RECEIPTS TO THE LAST [01:44:56.93] SLIDE -- RELATES TO THE LAST [01:44:58.17] SLIDE WHERE YOU WERE SHOWING THE [01:45:01.80] 14E AND ITS SOP REGARDING [01:45:03.63] DIFFERENT LEVELS OF PER MISCIBLE [01:45:08.03] RESEARCH AND DE FACTO SURROGATES [01:45:09.93] AND IT SEEMED LIKE YOU WENT VERY [01:45:11.73] QUICKLY OVER THE LAST ONE AND I [01:45:13.03] WANTED TO CONFIRM. [01:45:15.27] >> Scott Kim: MAYBE IF YOU COULD [01:45:15.93] CALL UP MY LAST SLIDE. [01:45:16.77] >> IT SEEMED LIKE THE DE FACTO [01:45:20.27] SURROGATE FAMILY MEMBERS WAS [01:45:22.03] EARLIER MANY PEOPLE HAD FELT [01:45:23.33] LIKE YES WHEN YOU HAD GIVEN THAT [01:45:24.60] AND NOW IT SOWNED LIKE THE SOP [01:45:26.40] WAS NOT PERMITTING THAT AND I [01:45:28.57] WONDERED, IT SEEMED TO ME MY [01:45:30.87] FIRST RESPONSE WAS OH, IS THAT [01:45:32.07] JUST TO PROTECT THE NIH AND NOT [01:45:33.77] IN FACT RELATED TO THE RESEARCH [01:45:35.00] SUBJECTS, SO MAYBE YOU COULD [01:45:36.43] JUST TALK ABOUT THAT. [01:45:38.03] >> Scott Kim: WOW. [01:45:38.47] HOW MUCH TIME DO YOU HAVE TO [01:45:39.13] TALK ABOUT THE TOPIC? [01:45:40.47] [LAUGHTER] [01:45:43.80] OKAY. [01:45:44.57] I'VE SORT OF MESHED IN LEGAL, [01:45:49.03] ETHICAL WITH EMPIRICAL STUFF. [01:45:52.43] A POLICY HAS TO FOLLOW SOME KIND [01:45:53.80] OF A LEGAL FRAMEWORK, AND WHEN [01:45:57.73] YOU HAVE THE LEGAL FRAMEWORK, [01:45:59.27] YOU HAVE A LOT OF PEOPLE WHO ARE [01:46:01.20] INTERESTED IN THAT KIND OF [01:46:04.53] ASPECT MORE AND HOW MUCH DATA [01:46:09.90] THAT GETS INCORPORATED INTO [01:46:11.67] INFORMING THAT KIND OF VARIES. [01:46:14.00] AND SOME COMMISSIONS ACTUALLY [01:46:15.27] LOOK AT DATA, SOME COMMISSIONS [01:46:19.07] DON'T. [01:46:19.47] I CAN'T EXPLAIN WHY, WHY THAT [01:46:22.73] HAPPENS. [01:46:23.63] IT'S THE MESSY WORLD OF [01:46:27.23] POLICYMAKING. [01:46:27.53] SO MY SHORT ANSWER IS YOUR [01:46:29.70] INTUITIONS ARE CORRECT. [01:46:32.53] WHY IT HAPPENS IS DUE TO SOME [01:46:37.20] MYSTERIOUS, YOU KNOW, SAUSAGE [01:46:41.27] CALLED POLICYMAKING AND I WASN'T [01:46:42.20] THERE WHEN THEY MADE THAT [01:46:43.67] SAUSAGE SO I DON'T KNOW. [01:46:44.77] BUT FROM AN ETHICAL POINT OF [01:46:46.27] VIEW, YOU'RE EXACTLY RIGHT, MOST [01:46:48.03] PEOPLE THINK THAT DE FACTO [01:46:51.73] FAMILY SURROGATE SHOULD BE [01:46:55.57] SUFFICIENT, AND WE TAKE COMFORT [01:46:57.97] IN JUDGING HAVING SAID XYZ WHEN [01:47:00.37] WE MAKE POLICY AND HOW DO YOU [01:47:02.43] BALANCE THAT. [01:47:03.00] IT'S A TOUGH ONE. [01:47:06.17] YES? [01:47:06.40] >> ISN'T IT TRUE THAT MANY [01:47:08.03] PEOPLE THINK DOING RESEARCH OF [01:47:10.87] GREATER THAN MINIMAL RISK WITH [01:47:12.10] NO BENEFIT IS NOT ACCEPTABLE, [01:47:15.13] PERIOD, FOR PEOPLE WHO CAN'T [01:47:16.53] CONSENT? [01:47:16.77] THERE ARE PEOPLE WHO THINK SO. [01:47:18.47] >> Scott Kim: LET ME PUT IT THIS [01:47:20.10] WAY. [01:47:20.27] IF YOU PROPOSE AND ASK THE [01:47:21.73] QUESTION THAT WAY, YOU WILL FIND [01:47:24.03] A NUMBER OF PEOPLE WILL SAY [01:47:25.77] THAT. [01:47:26.03] BUT IF YOU DESCRIBE A STUDY [01:47:27.73] WE'RE GOING TO DO A LUMBAR [01:47:29.57] PUNCTURE, WE'RE GOING ON DRAW [01:47:30.90] THIS, IT'S GOING TO BE USED TO [01:47:34.23] FIND ANALYZED CHEMICALS, AND [01:47:35.93] THIS WILL HAVE NO BENEFIT TO THE [01:47:37.53] PERSON WHAT EVERY SO, IT'S ONLY [01:47:38.60] TO TEST THE FLUID, SEE IF WE CAN [01:47:40.23] LEARN SOMETHING, YOU SAW THE [01:47:44.50] NUMBERS, 70, 80% WHO SUPPORT IT, SO, YOU K NOW, AGAIN, IT'S -- [01:47:52.03] YES? [01:47:52.83] >> SO I KNOW A PATIENT THAT'S [01:47:55.80] VERY SIMILAR TO WHAT YOU [01:47:58.40] DESCRIBE AS MR. S, SCHIZOPHRENIA [01:48:03.77] PATIENT WILL, SO IN THIS CASE [01:48:09.07] DIAGNOSED AS SZOEE IF HE CANITY, [01:48:12.57] BUT HE MEETS THE THRESHOLD FOR [01:48:14.67] MAKING CAPACITY, HAVING THE [01:48:15.97] CAPACITY FOR MAKING DECISIONS, [01:48:17.70] HOWEVER, HE GENERALLY HAS A VERY [01:48:21.57] STRONG OPPOSITION AGAINST ANY [01:48:23.00] MEDICINE, EVEN TREATMENT FOR [01:48:26.50] HIMSELF IN GENERAL, SO, YOU [01:48:28.67] KNOW, IN THIS CASE, IF THERE'S A [01:48:35.20] RESEARCH FOR TREATING HIS [01:48:36.63] DISORDER AND HIS FAMILY WHO HE [01:48:38.40] CHOSE TO BE ESTRANGED FROM BUT HIS FAMILY [01:48:47.57] STILL CARES ABOUT HIM AND WANTS [01:48:48.83] TO ENROLL HIM IN THIS CLINICAL [01:48:50.90] RESEARCH, KNOWING THERE'S A VERY [01:48:52.53] GOOD PROSPECT, THERAPEUTIC [01:48:54.33] PROSPECT, HOWEVER, BECAUSE HE [01:48:57.03] GENERALLY HAS A STRONG [01:48:58.67] OPPOSITION AGAINST ANY THERAPY, HOW WOULD YOU MAKE THE [01:49:04.47] MOST ETHICAL DECISION IN THIS [01:49:06.37] CASE REGARDING ENROLLING OR NOT [01:49:09.50] ENROLLING? [01:49:09.90] >> Scott Kim: SO HERE IS -- FOR [01:49:12.20] THE RESEARCH CONTEXT, IT'S [01:49:13.90] PRETTY STWRAIT -- [01:49:16.63] STRAIGHTFORWARD THE DISCUSSION [01:49:17.33] YOU DESCRIBE BECAUSE IF INDEED [01:49:18.97] THIS PERSON IS COMPETENT TO MAKE [01:49:20.50] HIS OWN DECISIONS, THEN IT'S [01:49:23.33] KIND OF -- IT'S A NONISSUE FROM [01:49:28.03] THE FAMILY'S WISHES BECAUSE YOU [01:49:29.67] CAN'T FORCE A PERSON TO BE IN A [01:49:31.40] RESEARCH STUDY, RIGHT, IF THEY [01:49:33.33] ARE CAPABLE OF REFUSING. [01:49:34.57] AND EVEN IF THEY WEREN'T, IF YOU [01:49:36.97] KNEW THAT WAS HIS PREFERENCE [01:49:38.83] WHEN HE WAS COMPETENT, THE IDEA [01:49:42.20] OF FAMILIES KIND OF FORCING A [01:49:43.97] PEOPLE TO BE IN AND TAKING [01:49:45.30] MEDICATIONS, I MEAN, JUST SECOND [01:49:46.43] DOWN, EVEN IN A CLINICAL CONTEXT [01:49:48.83] WHERE WE KNOW AND USE TREATMENTS [01:49:51.13] THAT HAVE BEEN SCIENTIFICALLY [01:49:53.60] STUDIED THAT IT'S BENEFICIAL, [01:49:55.20] THERE ARE ALL THESE OBSTACLES [01:49:57.33] THAT PREVENT SOMEBODY ELSE FROM [01:49:58.67] FORCING THAT ON ANOTHER PERSON. [01:50:04.20] SO OUR SOCIETY VALUES AUTONOMY [01:50:07.00] SO MUCH THAT THE LEVEL AT WHICH [01:50:09.10] THEY GET THAT LEGAL AUTONOMY IS [01:50:12.43] PRETTY LOW, OKAY, WHICH MEANS [01:50:15.10] THAT IT'S VERY DIFFICULT TO [01:50:16.43] FORCE THINGS ON PEOPLE, AND [01:50:18.50] MAYBE THAT'S THE WAY IT SHOULD [01:50:20.37] BE. [01:50:20.53] AND WE ACCEPT THE CONSEQUENCES [01:50:22.60] OF THAT, AND YOU CAN SEE THAT IF [01:50:24.47] YOU GO TO ANY MAJOR CITY IN [01:50:26.60] AMERICA, WALK AROUND THE [01:50:27.60] STREETS, OKAY? [01:50:28.53] BUT THAT'S THE VALUE THAT OUR [01:50:31.40] SOCIETY APPARENTLY IS OKAY WITH. [01:50:35.17] SO FROM THAT PERSPECTIVE, I [01:50:36.47] THINK THAT'S RIGHT. [01:50:37.23] IF THIS WERE A CLINICAL [01:50:38.93] SITUATION, I THINK THAT'S WHERE [01:50:41.20] THE ART OF BEING A CLINICIAN [01:50:44.07] COMES IN, WHICH IS YOU SPEND [01:50:46.43] TIME TALKING TO THE PATIENT, [01:50:47.77] TALKING TO THE FAMILY, AND YOU [01:50:48.90] TRY TO NEGOTIATE SOMETHING [01:50:50.37] THAT'S BEST FOR THE PATIENT. [01:50:52.33] PUTTING ASIDE THE LEGALISTIC, [01:50:54.10] YOU KNOW, OBSESSIONS THAT WE [01:50:55.43] TEND TO GET SIDETRACKED BY. [01:51:01.60] >> THANK YOU. [01:51:02.63] [APPLAUSE] [01:51:03.83] >> THANK YOU, SCOTT. [01:51:06.13] OKAY, 15-MINUTE BREAK. [01:51:07.67] COME BACK FOR BIG DATA. [01:51:10.43] [01:51:13.77] ALL RIGHT. [01:51:14.40] THANK YOU ALL FOR COMING BACK. [01:51:15.03] FOR OUR THIRD SESSION TODAY, WE [01:51:18.40] HAVE A NEW, THIS IS NEW TO THIS [01:51:19.93] COURSE, WE'RE GOING TO TALK [01:51:20.67] ABOUT THE ETHICS OF RESEARCH [01:51:22.10] WITH BIG DATA, SOMETHING THAT'S [01:51:24.73] ACTUALLY VERY IMPORTANT FOR ALL [01:51:25.77] OF US TO BE THINKING ABOUT, AND [01:51:30.03] WE ARE THRILLED TO HAVE WITH US [01:51:31.90] JEFF KAHN WHO IS AT THE BURMAN [01:51:34.97] INSTITUTE OF BIOETHICS AT [01:51:36.93] HOPKINS, IN FACT, IN THE LAST, [01:51:38.93] COUPLE MONTHS AGO WAS MADE THE [01:51:40.50] DIRECTOR OF THE BURMAN INSTITUTE [01:51:41.50] OF BIOETHICS. [01:51:43.43] SO WE ARE VERY PRIVILEGED TO [01:51:44.63] HAVE JEFF WITH US TODAY. [01:51:47.60] >> JEFF KAHN: THANK YOU, [01:51:51.03] CHRISTINE. [01:51:51.30] I'M GETTING OVER A LITTLE BIT OF [01:51:53.17] THE CRUD THAT'S GOING AROUND. [01:51:56.07] I'M SURE SOME OF YOU HAVE IT. [01:51:57.50] SO PARDON ME IF I SOUND A LITTLE [01:52:00.07] CROAKY. [01:52:00.57] IT'S A PLEASURE TO TALK WITH YOU [01:52:02.23] ABOUT THIS TOPIC, AND EVERYBODY [01:52:06.00] HAS A SOMEWHAT DIFFERENT VIEW [01:52:07.40] ABOUT WHAT THE ANSWER TO THE [01:52:08.57] QUELL OF WHAT IS BIG DATA -- THE [01:52:10.53] QUESTION OF WHAT IS BIG DATA, SO [01:52:12.20] THIS MIGHT BE A LITTLE DIFFERENT [01:52:13.10] THAN WHAT YOU HAVE THOUGHT WOULD [01:52:14.97] SATISFY THAT DEFINITION, BUT I'M [01:52:19.80] TRY TO BE A LITTLE EXPANSIVE AND [01:52:20.97] USE A NUMBER OF DIFFERENT KINDS [01:52:22.00] OF EXAMPLES, SO HERE WE GO. [01:52:27.53] FOR ME THE WAY TO THINK ABOUT [01:52:28.83] THIS IS SORT OF THE EXPANDING, [01:52:32.47] REALLY EXPLODING GROWTH OF DATA [01:52:34.33] THAT'S AVAILABLE FOR THE [01:52:35.37] PURPOSES OF RESEARCH, SO IT [01:52:37.23] COMES FROM VARIOUS SOURCES. [01:52:38.60] SO WE'VE GOT MUCH MORE PERSONAL [01:52:40.80] HEALTH DATA ONLINE THAN WE USED [01:52:46.57] TO. [01:52:46.80] I'LL SAY MORE ABOUT EACH THESE [01:52:48.37] THINGS. [01:52:48.60] THIS IS JUST TO GIVE YOU A SENSE [01:52:49.97] OF WHERE I'M HEADED. [01:52:51.13] A LOT OF THAT INFORMATION IS [01:52:52.97] CREATED BY US, SO I'M WEARING AN [01:52:55.27] APPLE WATCH, I'M SURELY MANY OF [01:52:57.60] YOU HAVE FIT BITS OR LIKE KIND [01:52:59.53] OF DEVICES ON YOUR WRISTS. [01:53:01.27] SO WE'RE CREATING DATA THROUGH [01:53:03.03] THE WEARING OF THESE DEVICES. [01:53:04.97] AS I HAVE DRIVING DOWN HERE FROM [01:53:06.80] BALTIMORE, MY WATCH REAMED ME [01:53:08.00] THAT I SHOULD GET UP AND WALK [01:53:09.43] AROUND A LITTLE BIT BECAUSE IT [01:53:10.50] WAS A TWO-HOUR AND SOMETHING [01:53:13.33] DRIVE. [01:53:13.57] NOT SO EASY TO DO, BUT OKAY, I [01:53:15.73] UNDERSTAND THE MOTIVATION. [01:53:17.87] BUT IT KNOWS WHAT'S HAPPENING IN [01:53:19.33] TERMS OF OUR HEALTH BEHAVIORS, [01:53:21.17] AMONG OTHER KINDS OF THINGS. [01:53:22.97] AND THEN THERE ARE EXAMPLES I'LL [01:53:25.20] SHARE WITH YOU OF HEALTH DATA [01:53:29.43] THAT WE PUT ONLINE OURSELVES. [01:53:31.97] THOSE SITES ACTUALLY HAVE BECOME [01:53:33.63] LESS POPULAR, I THINK PARTLY [01:53:35.13] BECAUSE OF THE WEARABLES, BUT [01:53:37.63] STILL A FEATURE OF THE KIND OF [01:53:39.77] INFORMATION THAT CAN BE [01:53:40.63] COLLECTED AND USED FOR RESEARCH [01:53:43.60] PURPOSES. [01:53:44.10] SO THERE'S A BIT OF THE POINT I [01:53:46.10] JUST MADE. [01:53:46.97] SOCIAL MEDIA, OF COURSE, HAS A [01:53:48.73] ROLE TO PLAY IN THIS. [01:53:50.50] I WAS IN A WORKSHOP THAT THE [01:53:56.70] NIAD HOSTED PROBABLY A YEAR AGO [01:53:58.73] ALREADY NOW SORT OF [01:54:00.27] BRAINSTORMING WITH THE [01:54:01.07] SCIENTIFIC COMMUNITY ABOUT THE [01:54:02.73] WAYS IN WHICH SOCIAL MEDIA COULD [01:54:03.97] BE USED TO IDENTIFY PEOPLE WHO [01:54:06.27] ARE INFECTED BY HIV, SO NOT [01:54:09.50] BECAUSE THEY WOULD DISCLOSE THAT [01:54:10.90] INFORMATION, BUT BECAUSE OF A [01:54:12.73] CERTAIN INFORMATION THAT THEY [01:54:13.83] WOULD SHARE AND THEIR LOCATION, [01:54:16.80] THEIR BEHAVIOR, WITH SOME HIGH [01:54:19.00] LEVEL OF PREDICTABILITY COULD [01:54:20.70] IDENTIFY USING TWITTER WHO WAS [01:54:24.53] LIKELY INFECTED WITH HIV. [01:54:27.37] SO THE INTERACTIONS BETWEEN [01:54:30.77] RESEARCHERS AND SUBJECTS OR [01:54:32.17] PARTICIPANTS IS REALLY QUITE [01:54:33.87] DIFFERENT. [01:54:34.17] THAT'S SORT OF PART OF THE [01:54:35.73] TAKE-HOME WHICH I'M GOING TO [01:54:36.87] THREAD THROUGHOUT MY REMARKS. [01:54:40.83] OKAY. [01:54:41.03] SO LET ME JUST NOW DRILL DOWN A [01:54:43.93] LITTLE BIT ON THE KINDS OF [01:54:46.07] HEALTH-RELATED INFORMATION OR [01:54:48.20] DATA THAT'S COMING FROM US THAT [01:54:51.10] IS GOING INTO THE CLOUD, SK [01:54:54.47] COLLECTED OR AVAILABLE FOR [01:54:57.10] RESEARCH NAWRPSES WE MIGHT CALL [01:54:58.50] BIG DATA. [01:55:00.37] SO R -- PURPOSES THAT WE MIGHT [01:55:02.47] CALL BIG DATA. [01:55:03.17] SO THAT INFORMATION THAT'S [01:55:04.63] ACTIVELY SUPPLIED BY INDIVIDUAL [01:55:05.80] USERS. [01:55:06.00] SO THESE CATEGORIES ARE SORT OF [01:55:07.43] IN THE PROCESS OF BEING [01:55:09.67] IDENTIFIED, SO I HAVE QUOTES [01:55:10.87] AROUND THAT, MAYBE IT'S NOT [01:55:12.17] EXACTLY THE RIGHT TERMINOLOGY. [01:55:16.97] SO OUR MEDICAL HISTORIES, [01:55:18.83] GENOMIC DATA THAT COME FROM [01:55:20.30] EITHER INTRER ACTIONS WITH THE [01:55:22.10] HEALTH -- INTERACTIONS WLT [01:55:23.00] HEALTH SYSTEM OR A DIRECT [01:55:25.60] CONSUME KINDS OF TESTING LIKE 23 [01:55:27.00] AND ME, AND THEN INFORMATION WE [01:55:28.63] MIGHT POST VIA SOCIAL MEDIA THE [01:55:29.80] ON WEB OR OTHER PLACES SO [01:55:35.03] FACEBOOK IS A DATA RICH [01:55:36.23] ENVIRONMENT FOR LOTS OF PUBLIC [01:55:38.60] HEALTH RESEARCH. [01:55:39.43] I'LL GIVE YOU ONE EXAMPLE. [01:55:40.60] MY CHILDREN ARE 24 DID 20 YEARS [01:55:43.17] OLD RESPECTIVELY, SO SEMI RECENT [01:55:46.13] COLLEGE GRAD AND ONE STILL IN [01:55:50.97] COLLEGE. [01:55:51.67] THERE ARE PUBLIC HEALTH [01:55:52.93] RESEARCHERS THAT USE FACEBOOK [01:55:54.23] PICTURES, SO PHOTOGRAPHS THAT [01:55:55.27] ARE AVAILABLE VIA FACEBOOK WHERE [01:55:58.13] COLLEGE STUDENTS HOLDING RED [01:56:00.20] DIXIE CUPS, SO ALGORITHMS [01:56:03.13] ACTUALLY MINE FACEBOOK TO [01:56:05.57] IDENTIFY PHOTOGRAPHS WITH KIDS [01:56:07.17] HOLDING RED DIXIE CUPS BECAUSE [01:56:09.40] THAT CONNOTES ALCOHOL [01:56:12.70] CONSUMPTION, SO THAT JUST TURNS [01:56:14.27] OUT TO BE A RELATIVELY GOOD [01:56:16.77] PREDICTOR OF THE USE OF ALCOHOL. [01:56:21.13] SO IT'S INTERESTING INFORMATION [01:56:22.27] THAT WE COULDN'T HAVE THOUGHT OF [01:56:23.83] AS BEING HEALTH RELATED THAT [01:56:24.93] PEOPLE ARE POSTING, SO IT'S YET [01:56:27.23] ANOTHER EXAMPLE OF MAKE SURE [01:56:28.33] YOUR KIDS ARE AWARE THAT [01:56:29.93] EVERYTHING THAT THEY WILL SHARE [01:56:32.90] VIA THESE MEANS IS AVAILABLE TO [01:56:37.07] LOTS OF OTHER PEOPLE FOR LOTS OF [01:56:38.80] DIFFERENT PURPOSES. [01:56:40.40] THERE'S THE INFORMATION THAT CAN [01:56:41.60] BE COLLECTED, SO I WOULD SAY IS, [01:56:44.93] FRANKLY, WHILE WE ALL INTERACT [01:56:46.67] ONLINE, WHETHER IT'S VIA SOCIAL [01:56:49.03] MEDIA, THE WEAR ABLES LIKE I [01:56:50.60] MENTIONED BEFORE, OUR PHONES, OF [01:56:52.33] COURSE, WHICH ARE NOT WEARABLE [01:56:53.83] IN THE SENSE OF WATCHES AND FIT [01:56:56.40] BITS BUT ACTUALLY WE HAVE ON OUR [01:56:59.67] PERSONS A LARGE PART OF THE DAY [01:57:01.10] SO ACT LIKE WEARABLE TION, THEN [01:57:02.83] THESE THINGS THAT ARE CALLED [01:57:04.17] PART OF THE QUANTIFIED LIFE. [01:57:08.23] SO PEOPLE SHARING LOTS OF THEIR [01:57:09.53] DATD WHICH BECOME PART OF THE [01:57:13.90] HEALTH RELATED DATA IN THEIR [01:57:14.97] LIVES. [01:57:15.27] THINGS LIKE THEIR LOCATION, THE [01:57:16.60] KIND OF INFORMATION THAT'S [01:57:17.63] COMING FROM THEM AND THEIR [01:57:21.03] BEHAVIOR. [01:57:23.70] THERE'S A LARGE N HEALTH EFFORT [01:57:25.20] THE NIH IS SUPPORTING TO TRY TO [01:57:27.07] CREATE PLATFORMS TO DO THIS IN A [01:57:28.73] MORE THROUGH-GOING AND [01:57:29.70] CONSISTENT WAY. [01:57:35.03] AMONG THE CHALLENGES, AND I'LL [01:57:36.43] AGAIN THREAD SOME OF THESE [01:57:37.47] THROUGHOUT MY REMARKS, AMONG THE [01:57:39.03] CHALLENGES ARE THAT THE [01:57:40.50] DISCLOSURES THE POTENTIAL USE [01:57:41.60] OF INFORMATION THAT COMES FROM [01:57:44.17] THESE SOURCES VARIES QUITE [01:57:47.43] DRAMATICALLY, AND EVEN WHEN THE [01:57:50.67] DISCLOSURES ARE GOOD AND HONEST [01:57:53.17] AND FULL, PEOPLE TEND NOT TO DO [01:57:56.43] MUCH IN TERMS OF REVIEWING THEM, [01:57:58.27] LET ALONE READING THEM, RIGHT? [01:58:00.07] SO THAT'S PART OF THE CHALLENGE. [01:58:03.03] SO IF YOU'RE IN THE BUSINESS OR [01:58:06.47] INTERESTED IN RESEARCH, AND I [01:58:08.17] MEAN BUSINESS IN THE SENSE OF [01:58:09.30] CORPORATE, IF YOU ARE INTERESTED [01:58:10.07] IN COLLECTION OF BIG DATA FOR [01:58:11.40] THESE KINDS OF PURPOSES, WHAT [01:58:13.13] WOULD YOU WANT TO COLLECT? [01:58:15.77] HOW WOULD YOU GET IT? [01:58:16.90] SO THIS IS WHAT THE M HEALTH [01:58:18.40] EFFORT IS TRYING TO FIGURE OUT. [01:58:20.00] HOW MUCH AND FROM WHERE? [01:58:21.30] SO PART OF THE CHALLENGE HAD [01:58:22.67] BEEN IN THE PAST, ALTHOUGH THIS [01:58:26.00] IS BEING OVERCOME BY TECHNOLOGY, [01:58:27.50] WAS JUST THE VAST AMOUNTS OF [01:58:29.87] DATA AVAILABLE CREATED A STORAGE [01:58:33.47] CHALLENGE. [01:58:33.87] WE WENT FROM KILL BIETSZ TO MEG [01:58:36.13] BIETSZ TO GIGABYTES TO TERABYTES [01:58:37.97] AND I DON'T KNOW WHAT COMES [01:58:38.70] AFTER THAT, SOMEBODY DOES, SO WE [01:58:40.97] NEED WAYS TO NOT ONLY COLLECT [01:58:44.93] BUT STORE SO IT CAN BE ACCESSED [01:58:46.30] IN WAYS THAT CAN BE USEFUL, SO [01:58:50.00] THAT'S A BIT OF A CHALLENGE, [01:58:51.63] ALTHOUGH NOW BEING OVERCOME BY [01:58:53.10] ALL THE CLOUD COMPUTING EFFORTS [01:58:54.60] GOING ON. [01:58:55.13] WHERE DOES IT COME FROM, WHAT'S [01:58:56.63] RELEVANT, WHAT DOES IT MEAN OF [01:58:57.50] COURSE IS A HUGELY PART OF THE [01:59:03.70] STORY AND THE QUESTION AND HOW [01:59:04.80] TO VALIDATE THE QUALITY OF THAT [01:59:08.87] DATA IS A CHALLENGE FOR [01:59:10.43] RESEARCH. [01:59:10.90] OKAY? [01:59:11.10] AND AS WE THINK ABOUT SORT OF [01:59:12.60] ALL OF THOSE QUESTIONS FROM A [01:59:17.03] RESEARCH PERSPECTIVE, WE NEED TO [01:59:18.97] ALSO BE THINKING ABOUT WHAT [01:59:20.27] CONDITIONS OR LIMITATIONS OF USE [01:59:21.90] THERE OUGHT TO BE SO IN TERMS OF [01:59:27.20] THINGS LIKE PRIVACY WHICH HAS [01:59:28.87] BEEN HISTORICALLY A VERY [01:59:31.90] IMPORTANT PART OF THE WAY WE [01:59:33.53] PROMISE PEOPLE THEIR DATA WILL [01:59:34.63] BE USED BUT WITH CERTAIN [01:59:35.93] PROTECTIONS. [01:59:36.23] WHAT SHOULD THOSE PROTECTIONS [01:59:37.13] LOOK LIKE IN THIS ENVIRONMENT? [01:59:38.30] I WOULD SAY NEW ENVIRONMENT, BUT [01:59:39.70] IT'S AN EVOLVING ENVIRONMENT. [01:59:45.97] AND DOES IT MATTER WHAT KINDS OF [01:59:47.33] URPSES THE DATA MIGHT BE PUT TO [01:59:48.67] OR FOR THE PURPOSE FOR WHICH IT [01:59:50.30] IS COLLECTED? [01:59:53.20] SO IS PUBLIC HEALTH USE SOMEHOW [01:59:56.30] JUSTIFY LESS DISCLOSURE OR [01:59:58.47] DIFFERENT USES WITHOUT [02:00:00.77] DISCLOSURE THAN MIGHT OTHER [02:00:01.67] KINDS OF RESEARCH? [02:00:05.00] WHICH IS WHERE THE ETHICS [02:00:05.97] QUESTIONS COME IN. [02:00:06.80] LET ME NOW BACKTRACK A LITTLE [02:00:12.87] BIT, THIS WILL HOPEFULLY ECHO [02:00:14.90] ANDIC PROBABLY BE REPETITIVE, [02:00:16.53] BUT THAT'S OKAY, OF WHAT YOU [02:00:17.87] HEARD EARLIER THIS MORNING. [02:00:18.87] LET'S STEP BACK AND TALK A [02:00:20.00] LITTLE BIT ABOUT WHERE WE CAME [02:00:21.23] FROM. [02:00:21.47] THIS WILL JUST BE ONE SLIDE. [02:00:23.07] SO I'M NOT GOING TO DRONE ON [02:00:24.97] HERE FOR 15 MINUTES. [02:00:28.13] THE HISTORY AND THE SORT OF [02:00:30.53] COMMITMENTS FOUNDATIONALLY TO [02:00:31.30] THE ETHICS OF RESEARCH INVOLVING [02:00:34.67] HUMAN SUBJECTS, PARTICIPANTS, [02:00:36.37] THERE'S A DEBATE EVEN WITHIN THE [02:00:38.00] ETHICS WORLD ABOUT WHEN TO USE [02:00:40.00] WHICH OF THOSE TERMS, GOES BACK [02:00:41.80] TO THE 1970S AND WAS REALLY A [02:00:45.90] COMMITMENT TO PROTECT PEOPLE, [02:00:49.67] RIGHT, PREBLGHT -- PROTECT [02:00:52.27] PEOPLE FROM BEING USED IN WAYS [02:00:53.70] THAT THEY EITHER DIDN'T INTEND, [02:00:55.37] DIDN'T UNDERSTAND OR MIGHT BE [02:00:57.30] EXPLOITATIVE OF THEM, AND THAT [02:01:00.57] WAS DRIVEN, [02:01:02.60] THAT CREATED THE MOTIVATION TO [02:01:04.43] PROMULGATE REGULATION THAT WAS [02:01:06.57] ABOUT REACTING TO SCANDAL AND [02:01:09.43] MISUSE, RIGHT? [02:01:10.40] SO THE EXAMPLES YOU I'M SURE ALL [02:01:12.00] KNOW OF THINGS LIKE THE [02:01:14.10] SO-CALLED TUSKEGEE SYPHILIS [02:01:16.63] STUDY, MISUSE OF CHILDREN IN [02:01:19.43] WILLOWBROOK, THERE'S A WHOLE [02:01:20.67] LONG LIST OF HISTORICAL STUDIES [02:01:22.40] WHICH I WON'T GO INTO. [02:01:24.43] SO THE IDEA WAS WE'RE GOING TO [02:01:26.57] PROTECT PEOPLE FROM THOSE KIND [02:01:28.90] OF BAD THINGS HAPPENING GOING [02:01:31.13] FORWARD, AND WE'RE GOING TO DO [02:01:32.33] THAT IN VARIOUS WAYS, AND IT [02:01:36.60] CREATED AN UNDERSTANDING ABOUT A [02:01:39.73] CONCEPTUAL RELATIONSHIP, BOTH [02:01:42.53] CONCEPTUAL AND ACTUAL, BETWEEN [02:01:44.97] RESEARCHERS AND SUBJECTS. [02:01:46.23] WE WOULD CALL THAT DIAD I CAN, [02:01:50.03] RIGHT? [02:01:50.27] I'M A RESEARCHER, YOU'RE A [02:01:51.97] SUBJECT, I'M GOING TO TALK TO [02:01:52.60] YOU ABOUT WHAT I'M GOING TO DO, [02:01:54.33] EXPLAIN TO YOU, YOU'RE GOING TO [02:01:55.77] SCE ME QUESTIONS, THERE'S A [02:01:57.10] PIECE OF PAPER I 23450ED YOU TO [02:01:58.17] SIGN SO IT -- AT THAT I NEED YOU [02:02:00.80] TO SIGN SO IT CAN GO INTO MY [02:02:02.77] FILES OF EVIDENCE OF THIS [02:02:04.73] CONVERSATION BUT WE'RE GOING TO [02:02:05.77] HAVE AN INTERACTION AND THAT'S [02:02:12.63] WORKED HAVE QUITE WELL, NOT [02:02:14.93] PERFECTLY, BUT THAT [02:02:15.60] UNDERSTANDING OF THE [02:02:16.30] RELATIONSHIP SEEMED TO CAPTURE [02:02:17.30] WHAT WAS GOING ON, AND THAT'S A [02:02:19.40] QUITE DIFFERENT INTERACTION THAN [02:02:20.50] THE ONE I'VE JUST DESCRIBED IN [02:02:22.87] BROAD BRUSH AND I'LL TALK A [02:02:24.17] LITTLE BIT MORE ABOUT WHICH [02:02:25.37] ISN'T ABOUT AN INDIVIDUAL [02:02:26.50] RESEARCHER TRYING TO RECRUIT AND [02:02:29.73] EXPLAIN WHAT KIND OF RESEARCH [02:02:30.77] THEY WANT TO DO TO AN INDIVIDUAL [02:02:35.07] RESEARCH SUBJECT AND SEEKING AND [02:02:36.70] HOPEFULLY RECEIVING THEIR [02:02:39.07] CONSENT SO HOW DO WE THINK ABOUT [02:02:41.53] THE SAME CONCERNS THAT MOTIVATED [02:02:42.83] THE REGULATIONS THAT WE HAVE [02:02:47.70] TOES IN TERMS OF THE NEW OR [02:02:50.33] EVOLVING ENVIRONMENT. [02:02:51.83] OKAY? [02:02:52.07] SO WE CAN POINT TO SOME OF THE [02:02:54.03] AREAS IN WHICH BIG DATA IS [02:02:59.13] COMING FROM, WHERE IT'S COMING [02:03:00.33] FROM, WHERE IT'S BEING CREATED, [02:03:01.80] AND THE KINDS OF STANDARDS THAT [02:03:02.90] EXIST IN THOSE ENVIRONMENTS. [02:03:06.20] SO WEB ORIENTED CONSENT, AND I [02:03:09.13] PUT QUOTES AROUND THAT FOR [02:03:10.70] REASONS I'M SURE YOU'LL [02:03:12.80] UNDERSTAND, ARE EXISTENT. [02:03:14.47] WE'VE GOT CONSENT IN THE CONTEXT [02:03:16.13] OF USE OF THE WEB, BUT THE WAY [02:03:18.57] WE THINK OF CONSENT THERE IS YOU [02:03:20.70] MUST CONSENT TO THIS VERY MANY [02:03:24.90] WORDS, VERY SMALL TYPE, IF YOU [02:03:26.53] WANT TO GO PAST THIS POINT ON [02:03:28.47] OUR WEBSITE, CLICK HERE IF YOU [02:03:30.57] AGREE OR CHECK THIS BOX AND THEN [02:03:32.97] CLICK HERE IF YOU AGREE. [02:03:37.10] RIGHT? [02:03:37.33] THAT'S VERY DIFFERENT THAN THE [02:03:38.40] WAY WE HAVE ENVISIONED AND [02:03:40.67] HOPEFULLY CARRY OUT CONSENT FOR [02:03:42.40] RESEARCH PARTICIPATION. [02:03:43.17] WE WOULD NEVER LET THAT HAPPEN [02:03:44.43] IN THE RESEARCH CONTEXT. [02:03:47.57] RIGHT SNT WE WOULDN'T PUT [02:03:48.67] SOMEONE IN FRONT OF A COMPUTER [02:03:49.67] AND SAY IF YOU WANT TO GO [02:03:50.97] FORWARD, YOU HAVE TO CLICK THIS [02:03:52.13] BUTTON. [02:03:52.37] WEAPON WOULDN'T LET THEM NOT [02:03:53.43] READ IT, WE WOULDN'T LET THEM [02:03:55.20] NOT HOPEFULLY UNDERSTAND IT OR [02:03:56.47] AT LEAST ASSESS WHETHER THEY [02:03:57.60] UNDERSTAND IT. [02:03:58.97] SO THE DE FACTO PRACTICE IN THE [02:04:02.70] INTERNET-BASED ENVIRONMENT HAS [02:04:04.57] GROWN UP TO THIS CLICK-THROUGH, [02:04:07.73] CLICK ROUTE IT'S SOMETIMES [02:04:08.93] CALLED OR CHECK BOX APPROACH [02:04:10.37] WHICH DOESN'T FIT WITH AT LEAST [02:04:12.50] A CONCEPTUAL COMMITMENT THAT [02:04:13.87] WE'VE MADE IN THE RESEARCH [02:04:17.00] CONTEXT SO THE PROBLEM IS, AS [02:04:19.00] THAT LAST BULLET SAYS, CONSUMER [02:04:20.73] PLATFORMS ARE STARTING TO BE [02:04:21.83] USED FOR RESEARCH PURPOSES AND [02:04:23.83] THAT'S NOT THE WAY WE THINK WANT [02:04:27.17] IT TO WORK. [02:04:28.00] SO TERMS OF SERVICE, PHONES, [02:04:29.80] SMARLT DEVICES, ALL THESE THINGS [02:04:31.10] WHERE YOU JUST HAVE TO SORT OF [02:04:32.40] TOUCH HERE IF YOU AGREE, EVERY [02:04:34.13] TIME YOU UPDATE THE OPERATING [02:04:36.00] SYSTEM ON YOUR MOBILE PHONE, I'M [02:04:39.60] AN APPLE GUY, SO A NEW IOS [02:04:42.47] AVAILABLE, CLICK HERE IF YOU [02:04:43.87] AGREE, YOU SCROLL THROUGH IT TO [02:04:45.37] GET TO THE BOTTOM BECAUSE THEY [02:04:46.20] MAKE YOU DO THAT, BUT NOBODY [02:04:47.37] READS IT. [02:04:47.93] I MEAN, MAYBE SOME REALLY SMALL [02:04:51.00] PROPORTION OF PEOPLE READ T I DO [02:04:55.97] NOT BECAUSE I WANT TO USE MY [02:04:57.97] PHONE. [02:04:58.20] SO THE PROBLEM IS YOU DON'T [02:04:59.30] REALLY HAVE AN OPTION, TO SAY I [02:05:01.03] WANT TO OPT OUT OF THIS AND [02:05:03.47] STILL BE ABLE TO USE THE [02:05:04.67] MATERIAL, SO WE HAVE TRAINED [02:05:05.97] PEOPLE TO SOMETHING QUITE [02:05:07.37] DIFFERENT THAN WHAT WE WOULD [02:05:08.27] THINK OF AS COMMITMENTS TO [02:05:09.80] INFORMED CONSENT AND THE WAY [02:05:12.20] WE'VE THOUGHT ABOUT IT IN [02:05:13.27] RESEARCH. [02:05:13.60] OKAY? [02:05:13.83] SO IT'S REGULATORY OR [02:05:15.57] CONTRACTUAL STANDARDS VERSUS [02:05:16.73] WHAT WE SHOULD THINK ABOUT AS [02:05:18.63] ETHIC STANDARDS OR COMMITMENTS [02:05:20.27] AROUND ETHICS. [02:05:25.50] AND THE ENVIRONMENTS ARE [02:05:26.93] CLASHING I GUESS IS HOW I WOULD [02:05:30.73] CONCLUDE THAT PART OF THE [02:05:32.17] DISCUSSION. [02:05:32.47] SO HOW SHOULD WE THINK ABOUT [02:05:34.90] CONSENT IN THIS EVOLVING [02:05:37.57] ENVIRONMENT FOR RESEARCH? [02:05:39.53] SO WHAT DO WE WANT TO ACHIEVE? [02:05:41.07] WHAT ARE THE GOALS? [02:05:43.17] AND I THINK YOU HEARD SOME OF [02:05:44.40] THIS I ASSUME FROM CHRISTINE IN [02:05:46.63] HER PRESENTATION, SO YOU WANT TO [02:05:48.27] DISCLOSE INFORMATION AND [02:05:50.43] SUFFICIENT INFORMATION AND [02:05:51.33] ACCURATE INFORMATION ABOUT WHAT [02:05:52.83] IT IS YOU'RE PROPOSING TO DO, [02:05:55.00] YOU WANT THE INDIVIDUAL TO [02:05:57.00] UNDERSTAND, RIGHT, THEY NEED TO [02:05:58.13] UNDERSTAND A FEW THINGS C WHAT [02:06:02.93] THE USES CRFT INFORMATION, BY [02:06:04.37] WHOM, FOR HOW LONG, THE [02:06:06.13] POSSIBILITY OF OTHER PEOPLE [02:06:07.77] HAVING ACCESS TO IT EITHER [02:06:08.60] BECAUSE YOU SHARE IT WITH THEM [02:06:09.80] OR BECAUSE THEY ACCESS IT EVEN [02:06:11.10] IF YOU DIDN'T SHARE IT WITH THEM [02:06:14.10] AND WHAT ARE THE RISKS AND [02:06:15.70] POTENTIAL BENEFITS OF YOUR [02:06:16.70] INFORMATION BEING USE IN THIS [02:06:20.60] WAY? [02:06:20.90] WECH THE PARTICIPATION TO BE -- [02:06:22.33] WE WANT THE PARTICIPATION TO BE [02:06:24.07] VOLUNTARY, RIGHT, WHICH REQUIRES [02:06:24.97] AN ACTION, RIGHT? [02:06:25.93] IT'S NOT VOLUNTARY IF YOU DIDN'T [02:06:27.93] KNOW ABOUT IT AND IT'S CERTAINLY [02:06:29.73] NOT VOLUNTARY IF YOU DIDN'T [02:06:31.30] AGREE TO IT, SO IT'S ALL NEEDING [02:06:33.83] TO BE DISCUSSED IN THE CONTEXT [02:06:38.13] OF AN EVOLVING DISCUSSION AND [02:06:40.40] CONCEPT OF HOW WE AS INDIVIDUALS [02:06:41.93] CONTROL INFORMATION ABOUT US, [02:06:46.87] WHICH IS CHANGING, RIGHT, FOR [02:06:48.67] GOOD OR FOR ILL, IT'S NOT THE [02:06:50.30] SAME AS IT WAS IN 1950 OR 1970. [02:06:57.23] ALL RIGHT? [02:06:59.27] SO THERE ARE SOME TIMES A [02:07:02.37] COLLECTION OF INFORMATION, IT [02:07:03.60] TURNS OUT, ON WEBSITE, THERE'S A [02:07:05.37] COLLECTION OF NCHTION THAT WILL [02:07:06.70] BE USED -- OF INFORMATION THAT [02:07:08.07] WILL BE USED FOR RESEARCH [02:07:09.27] PURPOSES AS A CONDITION OF THAT [02:07:10.73] SITE AND WHAT THEY'RE OFFERING. [02:07:16.63] FACEBOOK IS AN EXAMPLE. [02:07:19.27] SO YOU CAN'T OPT OUT TO THEIR [02:07:22.03] USE OF YOUR DATA, YOUR [02:07:25.03] INFORMATION FOR THEIR RESEARCH [02:07:26.57] PURPOSES IF YOU WANT TO USE [02:07:29.00] FACEBOOK. [02:07:29.30] SO IT'S A CONDITION OF THE USE [02:07:31.53] OF THAT SERVICE THAT YOUR [02:07:33.67] INFORMATION WILL BE USED IN [02:07:35.20] RESEARCH. [02:07:35.93] THAT'S REALLY DIFFERENT THAN THE [02:07:37.03] WAY WE HAVE THOUGHT ABOUT [02:07:39.53] RESEARCH PARTICIPATION IN A [02:07:41.80] BIOMEDICAL AND SOCIAL SCIENCE [02:07:44.43] CONTEXT. [02:07:46.70] RIGHT? [02:07:46.93] SO THERE ARE THREE THINGS THAT [02:07:48.20] THAT POINTS OUT. [02:07:49.87] ONE, THIS IS A GENERAL KIND OF [02:07:51.90] CONSENT, A BLANKET KIND OF [02:07:53.60] CONSENT FOR MORE THAN RESEARCH, [02:07:55.77] RATHER THAN CONSENT TO A [02:07:58.33] SPECIFIC, EITHER JUST TO DO [02:07:59.43] LERCH OR A SPECIFIC KIND -- TO [02:08:01.73] DO RESEARCH OR A SPECIFIC KIND [02:08:02.93] OF RESEARCH OR SPECIFIC PROJECT [02:08:04.80] OR RESEARCH USE. [02:08:05.97] SECOND, THE DISCLOSURE IS [02:08:08.27] BOILERPLATE, RIGHT? [02:08:08.87] IT'S JUST A LOT OF WORDS THAT [02:08:10.47] ARE MORE TO PROTECT THE ENTITY [02:08:16.17] THAN IT IS TO DISCLOSE [02:08:17.40] INFORMATION THAT'S USEFUL TO THE [02:08:19.57] USER/RESEARCH PARTICIPANT IN [02:08:22.27] THIS CASES -- CASE, AND ON THE [02:08:29.53] SLEU LAST SLIDE, BASED ON [02:08:32.90] CONSUMER AGREEMENT RATHER THAN [02:08:33.83] INFORMED CONSENT TO RESEARCH, [02:08:36.03] THEY'VE BUNDLED IT TOGETHER AND [02:08:37.40] IT ISN'T THE WAY WE HAVE THOUGHT [02:08:39.30] ABOUT IT'S APPROPRIATE FROM THE [02:08:41.23] CAN RESEARCH PERSPECTIVE. [02:08:43.53] SO THERE ARE ALTERNATIVE MODELS, [02:08:45.97] ONE IS YOU NEED TO OPT INTO THE [02:08:48.20] RESEARCH USE, WHICH SOUNDS A [02:08:50.40] WHOLE LOT CLOSER AND IS A WHOLE [02:08:51.97] LOT CLOSER TO HOW WE THINK OF [02:08:54.10] SATISFYING WHAT ARE THE [02:08:56.27] CONVENTIONAL CRITERIA OR THE [02:08:58.77] HISTORICAL AND FUNDAMENTAL [02:09:00.20] COMMITMENTS OF THE CRITERIA THAT [02:09:01.67] SATISFY INFORMED CONSENT FOR [02:09:05.37] RESEARCH, SO YOU CHECK THAT [02:09:06.37] YOU'RE WILLING TO HAVE YOUR DATA [02:09:07.30] USE IN THIS WAY, BUT IF YOU [02:09:08.63] DON'T CHECK IT, THEN YOUR DATA [02:09:10.83] WON'T BE USED IN THIS WAY, SO [02:09:12.80] IT'S SORT OF A SEPARATE CONSENT [02:09:14.17] FOR RESEARCH USE OF YOUR [02:09:18.87] INFORMATION AND THEN THE FLIP [02:09:19.77] SIDE OF THAT IS WE'LL USE YOUR [02:09:21.73] INFORMATION UNLESS YOU CHECK [02:09:22.60] HERE TO OPT OUT. [02:09:24.03] SO, YOU KNOW, WHEN YOU START AN [02:09:27.83] ACCOUNT ON A WEBSITE WHERE [02:09:29.50] YOU'RE BUYING SOMETHING, THEY'LL [02:09:30.87] OFTEN ASK YOU AT THE BOTTOM [02:09:32.50] CHECK HERE IF YOU WANT YOUR [02:09:34.73] INFORMATION TO BE SHARED WITH [02:09:36.03] OUR PARTNERS WHO WILL SEND YOU [02:09:38.33] THINGS OF GREAT INTEREST TO YOU. [02:09:41.30] RIGHT? [02:09:41.57] OR THE ALTERNATIVE IS CHECK HERE [02:09:43.07] IF YOU DON'T WANT US TO DO THAT. [02:09:45.57] YOU HAVE TO READ QUITE CAREFULLY [02:09:46.90] TO KNOW WHICH OF THOSE THINGS [02:09:48.07] THEY'RE ASKING YOU ABOUT, [02:09:48.93] WHETHER YOU WANT THAT BOX TO BE [02:09:50.23] CHECKED OR NOT, OTHERWISE YOUR [02:09:52.47] E-MAIL IN BOX IS GOING TO BE [02:09:53.73] EVEN FULLER THAN IT OTHERWISE [02:09:55.03] WOULD HAVE BEEN WITH STUFF YOU [02:09:56.80] DON'T CARE ABOUT. [02:09:59.60] RIGHT? [02:09:59.90] SO WHICH OF THE TWO WOULD WE SAY [02:10:02.30] IS A PREFERABLE OR MORE [02:10:05.47] CONSISTENT FROM AN ETHICS [02:10:07.60] PERSPECTIVE WITH THE COMMITMENTS [02:10:08.63] AROUND INFORMED CONSENT? [02:10:09.60] I WOULD SAY OPT IN, RIGHT? [02:10:11.03] BUT AT LEAST OPT OUT IS BETTER [02:10:12.87] THAN THIS GENERAL BLANKET KIND [02:10:16.13] OF CONSENT THAT WE HAVE SEEN [02:10:18.67] PROLIFERATE FROM SOME OF THESE [02:10:20.37] LARGE WEB-BASED PRESENCES. [02:10:23.47] SO IRSD I SAID THAT ENOUGH. [02:10:26.77] SO THERE ARE MANY EXAMPLES OF [02:10:31.43] COMPANIES LEARNING INFORMATION [02:10:32.53] ABOUT YOU. [02:10:33.03] THIS IS OBVIOUSLY FROM THE NEW [02:10:34.30] YORK TIMES MAGAZINE. [02:10:36.30] THAT'S A BIT OF A PROVOCATIVE [02:10:38.93] HEADLINE, BUT YOU GET THE POINT. [02:10:40.53] THE STORY THAT THIS PROMPTS ME [02:10:42.93] TO SHARE WITH YOU IS ONE YOU MAY [02:10:45.63] HAVE HEARD BEFORE. [02:10:47.73] BEFORE I CAME BACK TO HOPKINS, I [02:10:49.47] TRAINED AT HOPKINS BUT I WAS [02:10:51.27] AWAY FOR MOST OF MY CAREER, I [02:10:53.73] SPENT 15 YEARS AT THE UNIVERSITY [02:10:55.37] OF MINNESOTA WHERE I WORKED IN [02:10:57.17] THE MEDICAL SCHOOL AND THE [02:10:58.67] CENTER FOR BIOETHICS, AND DURING [02:11:02.97] THOSE 15 YEARS, THERE WAS A KIND [02:11:06.33] OF BROUHAHA AROUND TARGET, WHICH [02:11:09.40] IS HEADQUARTERED IN MINNEAPOLIS, [02:11:10.87] YOU MAY KNOW, BECAUSE TARGET IS [02:11:17.87] EVERYWHERE IN MINNESOTA, IF [02:11:19.20] ANYBODY IS A MINNESOTA AN, YOU [02:11:21.03] WILL ATTEST TO THIS. [02:11:22.07] THERE ARE MANY FLAVORS OF TARGET [02:11:24.90] YOU'VE NEVER SEEN BEFORE HERE IN [02:11:27.37] THE EAST COAST IN MINNESOTA, [02:11:29.00] MINI TARGETS DOWNTOWN MULTITI [02:11:30.63] STORY AND GIANT TARGETS WHERE [02:11:31.73] YOU CAN BUY PRETTY MUCH ANYTHING [02:11:33.30] YOU WANT OUT IN THE SUBURBS, I [02:11:35.00] THINK THEY'RE CALLED GREATLAND. [02:11:37.47] TARGET HAS A BIG PRESENCE. [02:11:39.53] THE STORY THAT RAN LOCALLY [02:11:41.83] EXPENLED UP MAKING NATIONAL NEWS [02:11:44.20] WAS A MAN SHOWED UP AT HIS LOCAL [02:11:47.03] TARGET TO COMPLAIN TO THE [02:11:48.00] MANAGER THAT HIS DAUGHTER WAS [02:11:51.17] GETTING INFORMATION IN THE MAIL [02:11:54.60] AT THEIR HOME FROM TARGET THAT [02:11:56.30] WAS OFFENSIVE TO THEM, TO THE [02:12:02.47] FAMILY, SO NOT THAT YOU CAN [02:12:04.33] COMPLAIN TO THE LOCAL MANAGER [02:12:05.63] ABOUT WHAT'S COMING FROM [02:12:07.17] CORPORATE TARGET BUT HE WAS [02:12:08.27] APPARENTLY NICE ABOUT IT AND [02:12:09.23] SAID I'M SORRY, WHAT'S GOING ON? [02:12:10.93] THE LONG STORY MADE SHORT IS THE [02:12:13.07] TEENAGE DAUGHTER IN THE HOUSE [02:12:14.87] WAS GETTING COUPONS IN THE MAIL [02:12:16.63] FOR THINGS RELATED TO SOMEONE [02:12:18.60] ABOUT TO HAVE A BABY, DIAPERS, [02:12:21.50] BABY WIPES, FORMULA, YOU KNOW, [02:12:23.97] SORT OF CONGRATULATIONS KIND OF [02:12:26.23] STUFF AND THEY WERE LIKE WHAT IN [02:12:27.30] THE WORLD? [02:12:28.10] WHY ARE YOU GETTING INFORMATION [02:12:29.50] FROM TARGET ABOUT HAVING A BABY? [02:12:31.57] YOU'RE A, I FORGET HOW WOULD, [02:12:34.03] 17-YEAR-OLD HIGH SCHOOL STUDENT? [02:12:34.87] SO HE WAS OH PHENYLED -- SOAFS [02:12:38.10] OH PHENOMENONNED AND SAID WHAT'S [02:12:40.43] TARGET DOING, THE MANAGER [02:12:44.30] APOLOGIZED PROFUSELY, YES [02:12:46.03] EMPLOYS HOME, THE DAUGHTER [02:12:48.83] CONFESSES KIM IN FACT PREGNANT, [02:12:50.67] BECAUSE SHE HAD AGAIN TO TARGET [02:12:52.47] AND PURCHASED CERTAIN THINGS, [02:12:53.77] THE ALGORITHMS WITHIN THE TARGET [02:12:56.03] MARKETING GROUP SAID WE THINK [02:12:57.57] SHE'S PREGNANT, WE'RE GOING TO [02:12:58.87] SEND HER INFORMATION THAT WILL [02:13:00.70] HELP HER COME TO US WITH COUPONS [02:13:02.00] AND BUY THE STUFF SHE NEEDS [02:13:03.40] AFTER HER BABY IS BORN. [02:13:07.97] SO TARGET FIGURED OUT BEFORE THE [02:13:11.20] PARENTS KNEW THAT THE [02:13:15.27] 17-YEAR-OLD GIRL WAS PREGNANT. [02:13:16.50] THAT'S SORT OF THE EXAMPLE OF [02:13:19.40] BIG DATA AND IT'S EVERY TIME GU [02:13:21.73] TO THE STORE, I DON'T HAVE ANY [02:13:23.10] KEYS BECAUSE I LEFT THEM WITH [02:13:24.67] THE VALET BECAUSE I WAS RUSHING [02:13:26.20] TO GET IN HERE, I HAVE MY KEY [02:13:28.90] CHAINS WITH THE WALGREENS, [02:13:32.27] WEGMAN'S IS A BALTIMORE THING, [02:13:34.13] WHATEVER, WHOLE NUMBER OF THINGS [02:13:34.93] THAT I SHOW SHOW AND BUY STUFF [02:13:37.63] AT THE STORE TO GET POINTS, [02:13:38.83] RIGHT, BUT EVERY TIME I DO THAT, [02:13:40.30] THEY KNOW THAT JEFF KAHN JUST [02:13:42.17] BOUGHT THESE THINGS AND IT GOES [02:13:43.63] INTO SOME DATABASE SOMEWHERE [02:13:45.87] ABOUT MY BUYING HABITS. [02:13:46.97] THAT'S BIG DATA. [02:13:51.63] THAT'S HOW TARGET FIGURED OUT [02:13:53.10] THIS YOUNG WOMAN WAS PREGNANT. [02:13:54.73] EVERY TIME YOU SWIPE YOUR CREDIT [02:13:56.30] CARD. [02:13:56.53] EVEN IF YOU DON'T USE THE CLUB [02:13:57.97] CARD, WHEN YOU BUY SOMETHING, [02:13:58.93] UNLESS YOU'RE PAYING WITH CASH, [02:14:00.20] YOU'RE JUST NOT ANONYMOUS, [02:14:01.60] RIGHT? [02:14:01.80] IT'S ALL BEING SLURPED UP. [02:14:13.77] SO THRISH USER OUTSIDE OF WHAT [02:14:14.43] WE THINK OF AFERS THE [02:14:15.93] TRADITIONAL RESEARCH [02:14:16.57] ENVIRONMENT, ALTHOUGH THAT [02:14:19.23] FRANKLY IS KIND OF AN ADJECTIVE [02:14:21.37] THAT SHOULD BE GOING AWAY. [02:14:22.77] WHAT DOES IT EVEN MEAN, [02:14:24.63] TRADITIONAL RESEARCH? [02:14:25.27] IT'S NOT A SENSIBLE WAY TO [02:14:27.03] DIVIDE THE WORLD. [02:14:28.40] SO I MENTIONED AT THE OUT SET [02:14:30.17] BUT NOW WE'RE SORT OF IN THE [02:14:32.00] FLOW HERE, SO SOCIAL MEDIA [02:14:34.73] CONTENT IS ABSOLUTELY RESEARCH [02:14:36.80] DATA, HUGELY RICH RESEARCH DATA. [02:14:39.50] I WENT TO A MEETING WHERE I WAS [02:14:41.67] THE ONLY ETHICS PERSON AMONG A [02:14:43.47] BUNCH OF PEOPLE WHO DO RESEARCH [02:14:44.83] ON TWITTER, WHO DO PUBLIC HEALTH [02:14:46.73] RESEARCH ON TWITTER, SO THEY'RE [02:14:48.10] LIKE A SUBSET OF A SUBSET, AND [02:14:51.17] THEY DO ALL SORTS OF INTERESTING [02:14:52.70] STUFF, NOT ONLY RELATED TO WHAT [02:14:54.50] PEOPLE ARE -- THEIR BEHAVIORS [02:14:56.27] ARE, BUT THEY COORKS FOR [02:14:57.47] INSTANCE, SMOKING INTERVENTION [02:15:00.30] RESEARCH. [02:15:01.07] INTERVENTION. [02:15:01.60] ACTIVE INTERVENTION RESEARCH VIA [02:15:03.57] TWITTER. [02:15:03.80] AND ALL THIS STUFF I HAD NO IDEA [02:15:07.73] ABOUT, AND I ASKED IN THE COURSE [02:15:09.03] OF THIS WORKSHOP WHAT KIND OF [02:15:12.03] DISCLOSURE THEY MAKE TO THE [02:15:12.90] PEOPLE WHO ARE THEIR RESEARCH [02:15:14.43] SUBJECTS AND THEY SAID, OH, WE [02:15:16.17] DON'T DISCLOSE ANYTHING. [02:15:16.87] WHAT DO YOU MEAN? [02:15:17.80] IT'S A FREE SPEECH ENVIRONMENT. [02:15:21.00] SO TWITTER IS THE PUBLIC SQUARE. [02:15:23.60] I WAS DRIVING HEERKS I WAS -- I [02:15:26.30] WAS DRIVING HERE, I WAS [02:15:27.63] LISTENING TO PUBLIC RADIO, [02:15:28.60] SOMEBODY WAS TALKING ABOUT HOW [02:15:29.53] TO CONTROL THE PROBLEM OF HATE [02:15:31.07] SPEECH ON TWITTER, RIGHT? [02:15:32.67] IT'S A FREE SPEECH ENVIRONMENT. [02:15:33.83] PEOPLE CAN SAY WHATEVER THEY [02:15:37.60] WANT AND THE PROBLEM IS [02:15:38.63] SOMETIMES WHATEVER THEY WANT [02:15:39.60] DROWNS OUT VIA HATE SPEECH OTHER [02:15:41.90] MORE PRODUCTIVE KINDS OF SPEECH [02:15:48.27] SO ON TWITTER THE ARG YOU'LL [02:15:49.67] FROM THE RESEARCHER'S [02:15:50.93] PERSPECTIVE IS WE DON'T NEED [02:15:52.57] CONSENT BECAUSE IT'S JUST LIKE [02:15:55.63] OVERHEARING PEOPLE IN PUBLIC [02:15:56.73] WHERE PEOPLE KNOW THEY'RE [02:15:57.83] TALKING IN A PUBLIC PLACE, WHAT [02:15:59.23] THEY'RE SAYING IS NOT PRIVATE, [02:16:00.67] AND THEY HAVE NO EXPECTATION OF [02:16:02.03] PRIVACY, IT'S PUBLIC SPEECH, AND [02:16:03.57] THEREFORE WE DON'T NEED CONSENT. [02:16:05.10] LIKE, WELL, GOSH TION ALL RIGHT, [02:16:06.60] THAT'S A REALLY DIFFERENT [02:16:08.57] ARGUMENT AND MODEL AND THEY'RE TRYING [02:16:12.90] FOIG THE FIGURE IT OUT, THEY [02:16:14.70] DON'T WANT TO HAVE TO GET [02:16:16.33] CONSENT BECAUSE IT WILL CHANGE [02:16:19.30] AND HOW THEY DO THINGS AND MAKE [02:16:20.60] IT HARDER AND IT WILL ALTER [02:16:23.50] PEOPLE EXRRKS THEY'LL THINK [02:16:24.67] OKAY, I'M A RESEARCH SUBJECT, [02:16:26.07] I'LL DO SOMETHING DIMPLET THAN [02:16:27.10] IF I DIDN'T KNOW I WAS BEING [02:16:28.57] OABLED. [02:16:28.80] SO THIS NOTION OF TERMS OF [02:16:31.13] SERVICE, DISCLOSING THAT YOU MAY [02:16:32.17] BE A RESEARCH SUBJECT WHEN [02:16:33.63] YOU'RE IN THIS ENVIRONMENT, THEY [02:16:35.27] CLAIM IS SORT OF EXRR GIVING [02:16:38.33] PEOPLE A WARNING AND IF THEY [02:16:40.13] DON'T READ IT, IT'S THEIR [02:16:42.10] PROBLEM, NOT OURS. [02:16:43.17] I DON'T AGREE WITH THAT. [02:16:44.90] SO WE HAVE TO HAVE A DISCUSSION [02:16:46.83] AS A RESEARCH COMMUNITY ABOUT [02:16:48.07] WHAT WE MEAN, WHAT CEMENT BY THE [02:16:51.67] PUBLIC NATURE OF CONTENT THAT [02:16:53.03] COMES OUT OF THE SOCIAL MEDIA [02:16:57.77] ENVIRONMENTS AND IS IT JUST LIKE [02:16:59.20] PUBLIC SPEECH AND THEREFORE WE [02:17:00.23] DON'T HAVE TO TREAT IT ANY [02:17:01.67] DIFFERENTLY OR SHOULD WE DO [02:17:03.20] SOMETHING THAT MAKES IT MORE [02:17:04.10] LIKE CONSENT FOR RESEARCH THAT [02:17:05.60] WE'RE USED TO? [02:17:06.80] IT'S AN OPEN DISCUSSION AND [02:17:09.33] QUESTION I THINK TO BE ADDRESSED [02:17:13.97] . [02:17:15.20] SO I MENTIONED THAT ALREADY. [02:17:20.03] ALL RIGHT. [02:17:20.70] I DON'T KNOW THAT I WANT TO DO [02:17:21.47] ALL THIS. [02:17:24.87] OKAY. [02:17:25.20] SO IN THE CONTEXT OF CERTAIN [02:17:26.77] KINDS OF RESEARCH, WE HAVE [02:17:29.83] HISTORICALLY ACKNOWLEDGED THAT [02:17:32.17] INDIVIDUAL PRIVACY MAYBE IS LESS [02:17:33.90] IMPORTANT, SO I'M THINKING OF [02:17:34.97] PUBLIC HEALTH. [02:17:35.60] SO CERTAIN KINDS OF INFECTIOUS [02:17:39.03] DISEASE DIAGNOSES ARE [02:17:40.53] REPORTABLE. [02:17:40.83] IT DOESN'T MATTER WHAT THE [02:17:41.83] INDIVIDUAL SAYS ABOUT THEIR [02:17:43.37] WILLINGNESS TO HAVE THEIR [02:17:44.77] INFORMATION SHARED WITH THE [02:17:46.97] AUTHORITIES, NOT ONLY IS IT [02:17:48.03] SOMETHING THAT'S PERMITTED, [02:17:49.13] YOU'RE OBLIGATED AS A [02:17:50.87] PROFESSIONAL, RIGHT? [02:17:52.37] CERTAIN REPORTABLE DISEASES, AND [02:17:53.90] WE SAY IN THE INTEREST OF THE [02:17:55.53] PUBLIC'S HEALTH, WE TRUMP YOUR [02:18:00.33] INDIVIDUAL RIGHTS. [02:18:01.63] SO WE HAVE TO HAVE THAT [02:18:03.57] CONVERSATION AS WELL. [02:18:04.67] SO FOR PUBLIC HEALTH PURPOSES [02:18:08.70] VERSUS RESEARCH, BIOMEDICAL [02:18:11.00] RESEARCH, VERSUS RESEARCH FOR [02:18:13.07] MARKETING, TARGET BEING THE [02:18:15.67] EXAMPLE, OR RECRUITING, LINKED [02:18:20.70] EXRIN, I GET INTERESTING [02:18:22.10] MESSAGES FROM LINKEDIN SAYING [02:18:24.83] PEOPLE, THERE'S A WHOLE LIST OF [02:18:27.17] THEM, SAYING PEOPLE ARE LOOKING [02:18:28.87] FOR SOMEONE LIKE YOU TO HIRE. [02:18:29.77] I DEPUTY KNOW I WAS LOOKING FOR [02:18:31.10] A JOB. [02:18:31.80] THERE'S OBVIOUSLY SOMETHING [02:18:32.80] HAPPENING VIA MY DATA ON [02:18:35.20] LINKEDIN WHICH IS BEING USED TO [02:18:36.50] SELL, I PRESUME, TO SOMEBODY, WE [02:18:38.20] HAVE REALLY GOOD CANDIDATES FOR [02:18:39.67] YOU TO RECRUIT FOR YOUR JOB [02:18:42.67] OPENINGS, SO THAT'S A DIFFERENT [02:18:44.03] USE OF MY DATA VERSUS OTHER [02:18:49.70] BUSINESS-RELATED MOTIVES, WE'LL [02:18:50.47] TALK ABOUT WHAT THOSE ARE IN A [02:18:55.53] SECOND. [02:18:56.23] HOW MANY OF YOU KNOW ABOUT THE [02:18:58.13] FACEBOOK SOCIAL CONTAGION SHERMT [02:18:59.70] IF I SAY THOSE WORDS? [02:19:01.40] -- EXPERIMENT IF I SAY THOSE [02:19:02.53] WORDS? [02:19:02.80] JUST A HANDFUL. [02:19:03.77] LET ME DO A LITTLE BACKGROUND [02:19:04.77] FOR THOSE OF YOU WHO DIDN'T [02:19:05.83] RAISE YOUR HAND. [02:19:12.80] FACEBOOK, IT TURNS OUT, AND LOTS [02:19:13.93] OF OTHER COMPANIES LIKE THEM [02:19:15.10] COLLECT DATA ABOUT THEIR USERS, [02:19:16.33] AS I MENTIONED BEFORE, BUT THEY [02:19:18.07] ALSO RUN LITTLE EXPERIMENTS, AND [02:19:21.63] NOT SO LITTLE IN THIS CASE. [02:19:23.20] SO BECAUSE FACEBOOK IS A VERY [02:19:25.57] LARGE POPULATION, A SMALL [02:19:28.50] PERCENTAGE OF THAT USER [02:19:30.07] POPULATION TURNS OUT TO BE [02:19:31.53] MILLIONS OF PEOPLE. [02:19:34.10] SO FACEBOOK IS ALWAYS INTERESTED [02:19:35.63] IN REFINING ITS OFFERINGS AND [02:19:40.03] ITS PRODUCT, AS ARE LOTS OF [02:19:42.67] OTHER SITES, AND IT CAME TO [02:19:44.63] LIGHT THAT THEY WERE DOING WHAT [02:19:46.83] MOST OF US IN THE ROOM I THINK [02:19:48.23] WOULD THINK OF AS RESEARCH ON [02:19:51.50] HUMAN SUBJECTS BECAUSE AN [02:19:53.13] ARTICLE WAS PUBLISHED IN THE [02:19:55.07] PROCEEDINGS OF THE NATIONAL [02:19:56.63] ACADEMY OF SCIENCES. [02:19:57.60] THIS IS AN OPINION PIECE THAT I, [02:19:58.97] AS YOU CAN SEE, WAS AMONG THE [02:20:03.30] AUTHORS OF IN THE AFTERMATH OF [02:20:04.97] THE DISCLOSURE OF THIS STUDY. [02:20:07.13] SO PNAS PUBLISHED A REPORT OF [02:20:10.23] THIS RESEARCH PERFORMED BY [02:20:13.20] FACEBOOK IN WHICH THEY [02:20:16.40] MANIPULATED, FACEBOOK COMPARED [02:20:20.40] THE POSTINGS OF INDIVIDUALS FOR [02:20:22.37] WHOM THEY SORT OF LEFT, YOU [02:20:25.50] KNOW, UNINTERFERED WITH AGAINST [02:20:27.63] SOME MILLIONS OF PEOPLE WHOSE [02:20:30.73] FEEDS THEY ALTERED. [02:20:31.93] THEY ALTERED THEM IN WAYS THAT [02:20:33.70] HAD EITHER MORE HAPPY POSTINGS [02:20:35.27] OR MORE SAD POSTINGS TO SEE [02:20:38.47] WHETHER THE ALTERATION OF THEIR [02:20:40.10] FEED ALTERED THE WAY THOSE [02:20:42.57] INDIVIDUALS WOULD POST. [02:20:44.47] SO THE SEEING MORE HAPPY -- SO [02:20:46.93] DOES SEEING MORE HAPPY POSTINGS [02:20:48.87] MAKE YOU POST MORE HAPPY THINGS [02:20:50.20] OR THE CONVERSE? [02:20:51.27] BUT THEY DIDN'T TELL PEOPLE [02:20:52.80] WE'RE GOING FOR A PERIOD OF TIME [02:20:54.53] TO NOT SHOW YOU AS MANY OF THE [02:20:56.23] HAPPY THINGS IN YOUR FEED AND [02:20:57.27] SEE HOW YOU REACT. [02:20:58.30] OF COURSE, YOU COULDN'T DO THAT, [02:20:59.67] IT WOULD RUIN THE RESEARCH. [02:21:00.77] IT NEEDED TO, IT RELIED ON SOME [02:21:03.90] LEVEL OF DECEPTION TO BE A [02:21:10.73] USEFUL RESEARCH PROJECT. [02:21:11.93] WHAT BROUGHT IT TO LIGHT IN THE [02:21:13.47] ACADEMIC WORLD IS THAT IT WAS [02:21:15.10] PUBLISHED IN PNAS BECAUSE ONE OF [02:21:16.90] THE PEOPLE WHO WAS A RESEARCHER [02:21:18.47] AT FACEBOOK WHO TOOK PART IN [02:21:21.00] PERFORMING THIS RESEARCH LEFT [02:21:23.07] FACEBOOK TO GO TO CORNELL, SEW [02:21:26.03] BECAME AN ACADEMIC -- SO HE [02:21:27.80] BECAME AN ACADEMIC, AND HE [02:21:28.73] NEEDED TO PUBLISH STUFF, AS [02:21:30.27] ACADEMICS DO, AND HE WANTED TO [02:21:32.17] PUBLISH IN A GOOD PLACE. [02:21:34.90] SO HE WAS THE INVESTIGATOR AND [02:21:39.10] FIRST AUTHOR BUT ALL THE OTHER [02:21:40.37] PEOPLE NAMED ON THE PAPER WERE [02:21:41.67] STILL AT FACEBOOK. [02:21:43.30] SO THE ONLY THING THAT MADE IT [02:21:45.33] PUBLIC WAS THAT IT GOT PUBLISHED [02:21:47.30] IN PNAS AND THE BLOW-BACK WAS [02:21:51.13] PARTLY WHAT IN THE WORLD THEY'RE [02:21:52.57] DOING RESEARCH WITHOUT TELLING [02:21:53.67] PEOPLE, AND THAT WAS ONE THING, [02:21:55.43] BUT THE OTHER THING WAS WHAT IS [02:21:57.77] PNAS DOING PUBLISHING RESEARCH [02:21:59.20] THAT IS EFFECTIVELY DECEPTION [02:22:01.27] RESEARCH AND DIDN'T GO THROUGH [02:22:02.60] AN IRB, IT TURNS OUT, AND [02:22:04.53] CERTAINLY DIDN'T GET CONSENT OF [02:22:05.87] THE SUBJECTS. [02:22:06.43] IT SEEMS TO VIOLATE THE [02:22:08.43] COMIMENTSZ THAT BUY -- THE [02:22:10.07] COMMITMENTS THAT BIOMEDICAL [02:22:11.63] JOURNALS SIGN ONTO AS PART OF [02:22:14.03] THE ICBME, WHATEVER THE ACRONYM [02:22:19.77] IS, INTERNATIONAL CONSORTIUM OF [02:22:23.37] COMMITTEE OF JOURNAL EDITORS, [02:22:24.60] I'M CLOSE, THERE'S PROBABLY A J [02:22:25.97] IN THERE I FORGOT. [02:22:27.07] BUT THAT, RIGHT? [02:22:28.60] WHICH PNAS SERCHL SIGNS ONTO BUT [02:22:30.73] THEY DIDN'T SOMEHOW APPLY THOSE [02:22:32.40] RULES TO THIS CR STUDY. [02:22:39.77] WHAT HAPPENS? [02:22:40.43] FACEBOOK SAYS WE DO THIS ALL THE [02:22:41.77] TIME, WE JUST DON'T PUBLISH IT [02:22:43.13] IN THE PLACES THAT YOU READ [02:22:45.37] ABOUT, WE DON'T PUBLISH IT [02:22:47.10] ANYWHERE, BECAUSE IT'S INTERNAL [02:22:48.20] INFORMATION FOR US TO MAKE [02:22:49.07] FACEBOOK BETTER AND THEN COME [02:22:50.67] FORWARD NUMEROUS OTHER CEO'S OF [02:22:53.03] LESSER KNOWN BUT STILL BIG SITES [02:22:56.17] LIKE OKAY CUPID, ANYBODY KNOW [02:22:57.77] THAT ONE, WHICH IS A DATING SITE [02:23:03.77] WHICH THE C HE O SAID WELL OF [02:23:05.27] COURSE WE DO THIS, AND THEN HE [02:23:07.10] DISCLOSED THAT NOT ONLY DO WE DO [02:23:09.40] SOMETHING LIKE I DESCRIBE, BUT [02:23:10.33] THEY DO IT WITH PEOPLE WHO [02:23:12.47] THEY'RE TRYING TO MATCH [02:23:13.43] TOGETHER, SO THEY ACTUALLY PUT [02:23:14.70] PEOPLE TOGETHER WHO DIDN'T MATCH [02:23:16.23] BUT TOLD THEM THAT THEY DID JUST [02:23:17.60] TO SEE WHETHER THEIR ALGORITHM [02:23:19.60] HAD ANY EFFECT ON WHETHER PEOPLE [02:23:21.20] ACTUALLY LIKED EACH OTHER. [02:23:22.07] SO TOTALLY DECEPTIVEMENT RIGHT? [02:23:25.23] HE SAID THAT'S HOW WE GET BETTER [02:23:26.57] AT WHAT WE DO. [02:23:27.60] WHY ARE YOU SO SPRIERSED BY [02:23:29.10] THIS? [02:23:29.30] SO IT WAS NOT SO MUCH, OH, GEE, [02:23:31.23] YOU FOUND US OUT, IT WAS RATHER, [02:23:33.17] WHY ARE YOU SO NAIVE NOT TO [02:23:34.63] THINK THAT WE DO THIS ALL THE [02:23:35.97] TIME? [02:23:36.63] WE CALL THAT QUALITY IMPROVEMENT [02:23:44.83] TRULY. [02:23:45.43] I'M NOT SAYING THAT [02:23:46.80] TONGUE-IN-CHEEK. [02:23:47.17] SO WE HAVE A KIND OF CLASH OF [02:23:48.93] CULTURES HERE IS THE POINT. [02:23:50.73] SO I WITH TWO COLLEAGUES WHO YOU [02:23:52.37] SEE LISTED THERE WROTE THIS [02:23:55.80] PIECE AT THE INVITATION OF THE [02:23:57.60] EDITOR, SWOWFT THINGS THAT [02:23:58.47] HAPPENS, RIGHT, SO PNAS, EGG ON [02:24:00.80] ITS FACE, THEY WERE REALLY LIKE [02:24:02.43] HOW DID THIS HAPPEN, THE [02:24:09.23] ACADEMIC PERSON WHO LEEPPEDZ THE [02:24:11.53] EDITORIAL BOARD HAPPENS TO BE [02:24:12.87] SOMEBODY I KNOW CALLED ME AND [02:24:13.83] SAID I NEED YOU TO HELP ME, I [02:24:15.73] SAID I CAN'T HELP YOU, YOU [02:24:17.10] STEPPED IN T YOU NEED TO FIX IT [02:24:18.73] YOURSELF, HE SAID NO, I WANT YOU [02:24:20.37] TO WRITE A PIECE ON WHAT WE DID [02:24:21.90] WRONG AND HOW WE MIGHT DO IT [02:24:23.77] BETTER. [02:24:24.00] I WAS LIKE OH, SURE, THAT I CAN [02:24:26.00] DO. [02:24:26.20] SO THIS WAS THE PRODUCT OF THAT. [02:24:34.20] HERE IS THE UPSHOT OF THAT [02:24:35.33] PIECE. [02:24:35.60] HERE ARE THE TAKE-AWAYS OF THE [02:24:37.37] ARTICLE THAT I JUST SHOWED YOU [02:24:39.30] EVER THE SCREENSHOT OF. [02:24:40.97] ONE, WE HAVE TO FIGURE OUT WHAT [02:24:42.80] COUNTS AS RESEARCH ON HUMAN [02:24:45.03] PARTICIPANTS OR HUMAN SUBJECTS. [02:24:46.03] SO WE'VE GOT A PROBLEM IN THAT [02:24:48.77] THE REGULATIONS, 45CFR46 SAYS [02:24:52.27] SOMETHING THAT DOESN'T REALLY [02:24:53.77] APPLY HERE. [02:24:54.43] IT'S A BAD FIT. [02:24:55.87] SO WE NEED TO ADDRESS THIS [02:24:58.10] PROBLEM OF REGULATORY FIT, AND [02:25:01.23] WE ALSO HAVE A PROBLEM OF THE [02:25:05.17] APPLICABILITY OF FEDERAL [02:25:07.03] REGULATION OUTSIDE OF THE THINGS [02:25:08.33] TO WHICH ACCOUNTS TECHNICALLY -- [02:25:12.37] TO WHICH IT IS TECHNICALLY [02:25:13.37] REQUIRED TO OVERSEE. [02:25:14.33] I WORK AT A UNIVERSITY AND MY [02:25:16.33] UNIVERSITY, LIKE MOST OTHER [02:25:18.03] RESEARCH INTENSIVE PLACES, SAYS [02:25:19.33] WE WILL OF COURSE APPLY 45CFR46 [02:25:22.27] TO THINGS THAT ARE FUNDED BY THE [02:25:23.67] FEDERAL GOVERNMENT BUT ALSO TO [02:25:24.57] EVERYTHING ELSE THAT WE DO, [02:25:25.80] THERE'S CAINT APPLICATION ACROSS -- THERE' S A CONSISTENT [02:25:28.97] APPLICATION ACROSS THE BOARD. [02:25:30.27] RIGHT? [02:25:30.50] THE PRIVATE SECTOR DOESN'T HAVE [02:25:31.67] THAT OBLIGATION AND IN FACT HAS [02:25:32.83] NO INTEREST IN DOING THAT SO [02:25:38.53] FACEBOOK, EXCEPT FOR THE FACT [02:25:39.53] THAT THE PERSON WHO WAS ONE OF [02:25:40.40] THE INVESTIGATORS LEFT FACEBOOK [02:25:42.07] TO GO INTO ACADEMIA WOULD NEVER [02:25:44.07] HAVE AN INTEREST IN PUBLISHING [02:25:45.43] IN PNAS, WHICH IS ACTUALLY A [02:25:50.20] PROBLEM BECAUSE NOW WE DON'T [02:25:51.63] KNOW ABOUT IT UNLESS THERE'S A [02:25:52.90] COLLABORATION BETWEEN THE [02:25:53.67] PRIVATE SECTOR AND ACADEMIA. [02:25:56.57] THE RESULT OF THIS FROM [02:25:58.60] FACEBOOK'S PERSPECTIVE IS WE [02:26:00.17] WILL NEVER EVER, EVER, EVER DO [02:26:02.43] THIS AGAIN. [02:26:03.13] WE DON'T WANT THIS KIND OF [02:26:05.30] ATTENTION. [02:26:05.57] IT'S REALLY BAD FOR US. [02:26:07.00] AND TO THE REST OF THE COMMUNITY [02:26:08.70] IN WHICH THEY LIVE, MAKE SURE [02:26:10.20] THAT WHEN THE PEOPLE WHO WORK [02:26:12.13] FOR YOU SIGN EMPLOYMENT [02:26:13.57] AGREEMENTS, WHEN THEY LEAVE, [02:26:14.60] THEY DON'T GET TO PUBLISH IN THE [02:26:16.30] ACADEMIC LITERATURE. [02:26:17.07] I MEAN, LITERALLY, JUST SILENCED [02:26:22.13] THIS POTENTIAL COLLABORATION [02:26:23.07] BECAUSE WE DON'T HAVE A GOOD [02:26:24.47] ANSWER TO THIS QUESTION. [02:26:27.37] SO WHAT DO WE MEAN BY INFORMED [02:26:29.33] CONSENT AND WHAT DO WE NEED IN [02:26:30.70] CON TECHS LIKE THIS? [02:26:32.43] -- IN CONTEXTS LIKE THIS? [02:26:34.23] IT TURNS OUT THAT THERE'S ALL OF [02:26:36.80] THE STATE VERSUS INTERNATIONAL [02:26:38.87] JURISDICTIONAL STUFF THAT [02:26:39.73] CROPPED UP BECAUSE NOT [02:26:46.23] SURPRISINGLY FACEBOOK WHILE IT [02:26:47.43] DOES LIVE SOMEPLACE, THERE ARE [02:26:49.17] PEOPLE WHO WORK AT FACEBOOK, [02:26:50.47] MOST OF WHOM ARE IN THE BAY AREA [02:26:52.27] OF CALIFORNIA, IT DOESN'T [02:26:53.30] RESPECT BORDERS, RIGHT? [02:26:54.63] IT'S HOW MANY BILLION USERS? [02:26:57.07] ROUND NUMBERS, ALL OVER THE [02:26:58.53] WORLD. [02:26:58.87] SO THIS WHOLE NOTION OF WHERE [02:27:00.57] ARE THE JURISDICTIONAL LINES [02:27:02.20] REALLY DON'T MAKE A LOT OF [02:27:03.50] SENSE. [02:27:03.73] WE HAVE TO FIGURE THAT OUT AND [02:27:05.10] THERE NEEDS TO BE SOME SORT OF [02:27:07.23] CONSISTENT APPROACH IN [02:27:08.63] PARTICULAR BECAUSE THE EU HAS A [02:27:10.33] REALLY DIFFERENT SENSE OF WHAT [02:27:11.50] PEOPLE'S RIGHTS ARE IN RELATION [02:27:12.67] TO THE INTERNET THAN DO WE IN [02:27:14.77] THE U.S., JUST FOR INSTANCE. [02:27:18.57] THEN BACK TO THE POINT I MADE [02:27:20.50] EARLIER, WHAT SHOULD BE THE [02:27:21.37] RULES FOR PUBLICATION IF THERE [02:27:23.10] EVER WERE AGAIN AN EXAMPLE LIKE [02:27:25.40] THIS? [02:27:25.63] AS I SAID, IT'S NOT GOING ON [02:27:26.93] HAPPEN AGAIN FOR A WHILE UNLESS [02:27:28.63] WE MAKE IT A CONDUCIVE [02:27:30.33] ENVIRONMENT FOR THIS KIND OF [02:27:32.07] COLLABORATIVE STUFF TO HAPPEN. [02:27:35.03] I'M WATCHING THE CLOCK UP THERE. [02:27:37.77] SO YOU WANT NOTICE STOP, I [02:27:40.10] ASSUME, AT -- [02:27:41.17] >> 20 MINUTES. [02:27:43.33] >> JEFF KAHN: 20 AFTERMENT [02:27:45.27] OKAY. [02:27:45.47] SO WHAT SHOULD WE DO? [02:27:52.63] ARE YOU WON'T BE SURPRISED [02:27:53.87] BY ANY OF THIS, SO DON'T SIT ON [02:27:56.03] THE EDGE OF YOUR SEATS HERE. [02:27:57.37] HOW CAN WE START MAKING THIS [02:27:58.93] BETTER? [02:27:59.30] WE NEED NEW THINKING, YOU CAN [02:28:00.87] SEAL SOME OF THIS HAS STARTED TO [02:28:02.93] PERCOLATE ALREADY, ABOUT WHAT [02:28:04.37] CONSENT OUGHT TO LOOK LIKE AND [02:28:11.00] FOR WHAT CR FOR LACK OF A BETTER [02:28:14.23] TERM, DATA RICH DATA, WE DON'T [02:28:16.47] HAVE TERMS FOR THIS YET, SO AT A [02:28:18.47] BARE MINIMUM, WE NEED TO BE [02:28:19.50] BETTER ABOUT THE DISCLOSURES [02:28:21.03] ABOUT WHAT'S ACTUALLY HAPPENING. [02:28:26.57] SECOND, WE NEED TO FIGURE OUT [02:28:28.20] WHAT LEVELS OF PRIVACY [02:28:29.40] PROTECTION OUGHT THERE TO BE, [02:28:30.87] AND PART OF WHAT WE DON'T REALLY [02:28:33.43] KNOW IS WHAT PEOPLE REALLY [02:28:34.83] EXPECT. [02:28:35.07] THERE'S A LOT OF ANECDOTAL AND [02:28:36.90] SOME OF IT PEOPLE ARGUE EXCUSE [02:28:38.97] BY AGE, BUT IT'S REALLY NOT SO [02:28:42.57] PREDICTIVE. [02:28:42.87] IT TURNS OUT IT WOULD BE GREAT [02:28:44.97] IF WE COULD FIGURE OUT WAYS, AND [02:28:47.50] WE SHOULD, BECAUSE THE [02:28:50.10] TECHNOLOGY AVAILABLE VIA THE [02:28:51.53] WEB, VIA MOBILE, VIA ALL OF THE [02:28:55.13] KINDS OF ELECTRONIC STUFF THAT'S [02:28:56.60] HAPPENING NOW THAT DON'T REQUIRE [02:28:58.90] PIECES OF PAPER TO BE ABLE TO DO [02:29:00.83] SOMETHING THAT'S MORE DYNAMIC [02:29:03.07] AND CONTENT-SPECIFIC RATHER THAN [02:29:04.37] SALE HERE IS A GENERAL KIND OF [02:29:06.17] CONSENT, READ IT AND SIGN IT IF [02:29:08.17] YOU'RE WILLING, AND THERE ARE [02:29:09.00] PEOPLE WHO ARE WORKING ON THAT. [02:29:12.10] JOHN WILBANKS AT SAGE [02:29:15.70] BIONETWORKS IS REALLY A GREAT [02:29:16.97] EXAMPLE OF SOMEONE WHO IS REALLY [02:29:18.50] PUSHING HARD, WHO DIDN'T COME [02:29:19.70] INTO THIS DISCUSSION FROM EITHER [02:29:21.33] RESEARCH OR ETHICS OR HUMAN [02:29:24.93] SUBJECTS PROTECTION BUT, RATHER, [02:29:25.90] IS MORE OF A CY TECH KIND OF GUY [02:29:33.57] AND SAID IF YOU WERE STARTING [02:29:35.03] FROM SCRATCH, YOU WOULDN'T DO IT [02:29:36.30] THIS WAY, WHICH OF COURSE IS [02:29:38.87] RIGHT. [02:29:39.10] SO WHAT WOULD BE GREAT IS TO [02:29:41.10] ALLOW INDIVIDUALS TO MANAGE THE [02:29:42.80] USE OF INFORMATION ABOUT THEM, [02:29:44.30] AND IN FACT THAT'S WHAT THE M [02:29:46.23] HEALTH PLATFORM APPROACHES ARE [02:29:49.87] ABOUT. [02:29:50.33] SO INDIVIDUALS MAY BE WILLING TO [02:29:51.47] HAVE SOME KIND OF INFORMATION [02:29:52.80] SHARED ABOUT THEM FOR SOME USES [02:29:55.60] BUT NOT OTHERS, AND IT SHOULDN'T [02:29:57.03] BE THAT HARD FOR THEM TO CHECK [02:29:59.10] VIA EITHER A MOBILE APP ON THEIR [02:30:01.03] PHONE ARE ON THE WEB OR SOMEHOW [02:30:03.20] SUCH THAT THAT JUST LIVES IN A [02:30:05.90] DATABASE SOMEWHERE THAT THEN [02:30:07.40] WHEN THE QUERY COMES, YOU GET [02:30:09.23] WHAT YOU'RE SUPPOSED TO GET AND [02:30:10.17] YOU DON'T GET WHAT YOU'RE NOT [02:30:11.40] SUPPOSED TO GET AS A RESEARCHER. [02:30:13.37] IT SHOULDN'T BE THAT [02:30:14.97] COMPLICATED. [02:30:15.27] SO WE NEED TO MAKE SURE PEOPLE [02:30:17.30] ARE COMFORTABLE AND CONFIDENT [02:30:19.87] ABOUT THEIR CONTROL OVER THE [02:30:21.83] ACCESS TO THEIR PRIVATE [02:30:25.00] INFORMATION. [02:30:25.40] THAT'S THE GOAL, WHICH SOUNDS, [02:30:28.17] RIGHT, MOM AND APPLE PIE, DOING [02:30:30.23] IT IS NOT THAT EASY. [02:30:31.60] THE PROBLEM IS IF WE DON'T [02:30:32.97] FIGURE THIS OUT, THEN WE HAVE A [02:30:35.00] PROBLEM OF CREDIBILITY, AND THAT [02:30:36.63] GOES BACK TO THE BEGINNING, [02:30:38.60] FRANKLY. [02:30:38.83] WHY DO WE NEED STRONG [02:30:40.53] PROTECTIONS? [02:30:40.83] BECAUSE, ONE, WE WANT TO PROTECT [02:30:42.17] PEOPLE, BUT, TWO, IF PEOPLE [02:30:43.90] DON'T FEEL LIKE THERE ARE [02:30:45.10] APPROPRIATE PROTECTIONS IN [02:30:45.87] PLACE, THEY WOULDN'T PARTICIPATE [02:30:46.77] IN RESEARCH. [02:30:47.60] IT'S A TRUST PROBLEM. [02:30:51.03] AND IF WE HAVE LIMITED -- FEW IS [02:30:53.50] NOT THE RIGHT WORD HERE -- [02:30:56.77] LIMITED STANDARDS AROUND THE [02:30:57.67] ETHICS OF THIS KIND OF RESEARCH, [02:30:59.10] THEN WE MAY HAVE EVEN A WORSE [02:31:00.67] PROBLEM. [02:31:01.00] SO IF WE'RE NOT COMMITTED IN A [02:31:02.50] WAY THAT SEEMS SUFFICIENT, THEN [02:31:04.00] IT MAY BE WORSE THAN HAVING NO [02:31:05.80] STANDARDS AT ALL. [02:31:08.20] SO SORT OF CHOOSE YOUR POISON, I [02:31:10.87] GUESS. [02:31:11.07] ALL RIGHT. [02:31:12.00] SO AS I HAVE SAID, IT'S REALLY [02:31:17.63] TIME THAT IT'S HAPPENING, [02:31:19.83] PROBABLY CLEARLY NL AS QUICKLY [02:31:20.93] AS IT NEEDS TO BAWMP THE WORLD [02:31:23.67] IN WHICH THIS KIND OF DATA IS [02:31:24.83] BEING COLLECTED FOR RESEARCH [02:31:27.03] PURPOSES, IT'S GOING QUICKER [02:31:28.47] THAN WE ARE IN TRYING TO FIGURE [02:31:29.63] OUT HOW TO HANDLE THIS PROBLEM [02:31:35.87] BUT WE NEED TO WORK TO CREATE [02:31:37.60] APPROACHES. [02:31:37.90] HERE ARE A FEW THINGS THAT ARE [02:31:39.00] IN A PAPER THAT HE IF I VAYENNA [02:31:43.83] WHO WAS ON THAT FACEBOOK OPINION [02:31:45.37] PIECE WITH PNAS WITH ME HAS [02:31:51.07] SUGGESTED. [02:31:52.27] AGAIN, NONE OF THIS IS EARTH [02:31:54.00] SHAKING BUT IT'S A HELPFUL KIND [02:31:55.43] OF FRAMING. [02:31:56.40] CLOSING THE GAPS IN OVERSIGHT, [02:31:58.10] THAT'S ABOUT CLARITY, WHAT DO WE [02:31:59.90] MEAN, SO AS YOU'VE HEARD EVEN IN [02:32:04.03] MY FEW MINUTES OF TALKING, IT'S [02:32:05.83] NOT CLEAR WHAT WE MEAN BY BIG [02:32:07.70] DATA, DATA RICH, WHATEVER THIS [02:32:08.60] IS, WE NEED SOME CLARITY ABOUT [02:32:10.10] WHAT IT IS SO PEOPLE UNDERSTAND, [02:32:11.50] STANDARDS FOR PRIVACY AND GET [02:32:16.60] SOME BEST PRACTICES GOING THAT [02:32:17.80] OTHERS CAN LEARN FROM. [02:32:20.20] TECHNOLOGICAL SOLUTIONS, AND [02:32:26.33] OVERSIGHT CAN BE DIFFERENT FOR [02:32:28.37] DIFFERENT KINDS OF DATA. [02:32:29.77] RIGHT? [02:32:30.00] SO THINGS THAT ARE MORE [02:32:32.17] SENSITIVE CAN BE TREATED [02:32:33.23] DIFFERENTLY THAN THINGS THAT ARE [02:32:34.50] LESS SENSITIVE. [02:32:35.83] SO TIERED ACCESS ON THE PART OF [02:32:37.83] THE INDIVIDUAL BASED ON WHATEVER [02:32:38.93] YOU WANT AND THEN VARIABLE [02:32:41.20] ACCESS AS A RESEARCHER BASED ON [02:32:43.17] THE CRITERIA OF RISK/BENEFIT. [02:32:46.13] SO SORT OF IT ALL CAN BE MOVED [02:32:48.97] AROUND IN WAYS THAT ARE NOT THAT [02:32:50.57] HARD TO DO WITH TECHNOLOGICAL [02:32:53.57] TECHNICAL APPROACHES THAT WE [02:32:55.03] HAVE ACCESS TO IN OTHER PARTS OF [02:32:57.37] OUR LIVES. [02:32:57.90] AND THEN WE NEED STAKEHOLDER [02:33:01.00] ENGAGEMENT AND INVOLVEMENT SORT [02:33:03.17] OF THROUGHOUT THE WHOLE PROCESS [02:33:04.83] HERE, SO THAT THE PEOPLE WHO DO [02:33:06.07] THE RESEARCH, THE PEOPLE WHO [02:33:07.77] OVERSEE THE RESEARCH, PRIVATE [02:33:10.93] SECTOR WHICH INDUSTRY IN THE [02:33:12.03] SENSE OF THE KIND OF INDUSTRY [02:33:13.30] I'VE BEEN TALKING ABOUT RATHER [02:33:15.23] THAN INDUSTRY LIKE PHARMA, [02:33:17.03] RIGHT, DIFFERENT NOTION OF [02:33:18.47] INDUSTRY, THE REGULATORY [02:33:20.97] ENTERPRISE, PEOPLE WHO DO ETHICS [02:33:23.87] OF RESEARCH, THE PLACES WHERE [02:33:25.40] THAT RESEARCH MIGHT BE PUBLISHED [02:33:26.77] BECAUSE WE WANT IT TO BE A [02:33:28.57] CONDUCIVE ENVIRONMENT, NOT ONE [02:33:29.77] WHERE PEOPLE SAY I DON'T WANT [02:33:30.80] ANY PART OF IT, AND OF COURSE [02:33:32.33] THE PEOPLE WHOSE DATA WE'RE [02:33:34.13] TALKING ABOUT USING FOR [02:33:36.73] RESEARCH. [02:33:37.00] THERE YOU GO. [02:33:39.53] 18 AND 44 SECONDS, THAT WAS [02:33:41.17] PRETTY CLOSE TO 20. [02:33:42.20] THANK YOU. [02:33:44.63] [APPLAUSE] [02:33:46.60] >> Christine Grady: QUESTIONS [02:33:47.23] FOR JEFF? [02:33:53.17] >> JEFF KAHN: OR NOT. [02:33:56.67] I COULD HAVE GONE FOR 10 MORE [02:34:00.73] MINUTES. [02:34:00.97] >> SO I ACTUALLY HAVE MORE [02:34:04.63] COMMENTS RATHER THAN QUESTIONS, [02:34:05.53] BUT THE FIRST ONE IS THAT IN [02:34:08.50] TERMS OF THE INFORMED CONSENT [02:34:12.03] AND FACEBOOK VERSUS BIOMEDICAL [02:34:15.73] RESEARCH, ET CETERA, WHAT WE DO [02:34:18.97] HEAR, IT SEEMS TO ME THAT IN THE [02:34:20.87] END THEY'RE VERY SIMILAR IN THAT [02:34:24.10] IF YOU WANT THE PROCEDURE OR YOU [02:34:25.83] WANT THE GENE THERAPY OR EVEN [02:34:28.57] JUST PARTICIPATE HERE AT NIH, IN [02:34:31.33] THE END YOU HAVE TO SIGN THAT [02:34:33.97] CONSENT. [02:34:34.20] SO I MEAN, EVEN THOUGH WE TRY TO [02:34:39.20] DO A BETTER JOB WITH INFORMED [02:34:43.43] CONSENT AND ETHICALLY HAVE THAT [02:34:47.57] PERSON PARTICIPATE AND BE BETTER [02:34:50.87] INFORMED, IN THE END, THEY HAVE [02:34:51.87] TO SIGN THE CONSENT. [02:34:53.73] >> JEFF KAHN: SURE. [02:34:55.10] BUT THEY ARE COMING HERE FOR THE [02:34:56.30] PURPOSE OF PARTICIPATING, RIGHT, [02:34:59.03] IN SOMETHING THAT HOPEFULLY THEY [02:35:00.83] UNDERSTAND IS RESEARCH. [02:35:01.53] >> RIGHT. [02:35:02.10] >> JEFF KAHN: I THINK THE [02:35:03.70] REALLY IMPORTANT DIFFERENCE IS [02:35:04.77] THAT THE DATA THAT COMES FROM MY [02:35:08.73] WATCH, WHEN I'M WALKING AROUND [02:35:09.97] DURING THE COURSE OF THE DAY, I [02:35:11.50] DON'T THINK OF AS BEING LIKE [02:35:13.60] COMING TO PARTICIPATE IN A GENE [02:35:15.77] TRANSFER TRIAL. [02:35:17.33] RIGHT? [02:35:18.20] AND SO I THINK PEOPLE DON'T [02:35:20.80] UNDERSTAND AND THAT'S [02:35:21.90] PROBLEMATIC IF PEOPLE DON'T [02:35:23.00] UNDERSTAND WHAT THEY'RE GETTING [02:35:24.07] INTO. [02:35:24.27] WE TRY REALLY HARD TO AVOID THAT [02:35:26.00] IN THE RESEARCH CONTEXT. [02:35:27.00] >> RIGHT. [02:35:27.53] >> JEFF KAHN: AND I KNOW IN [02:35:29.10] PLACES LIKE THIS, RIGHT, SO WHEN [02:35:30.57] YOU DRIVE UP TO THE CIRCLE, IT [02:35:32.37] FEELS LIKE A HOSPITAL. [02:35:35.10] THAT'S A CHALLENGE, RIGHT? [02:35:36.40] IT'S CALLED THE CLINICAL CENTER, [02:35:39.10] EVEN THOUGH WHAT HAPPENS HERE IS [02:35:40.50] RESEARCH, RIGHT? [02:35:42.20] SO IT'S KIND OF A VERSION OF [02:35:43.47] THAT PROBLEM, BUT I WOULD ARGUE [02:35:44.97] IN A WAY MUCH HARDER FOR PEOPLE [02:35:47.83] TO UNDERSTAND, THAT THEY JUST [02:35:49.13] DON'T KNOW. [02:35:50.00] IT'S NOT ACCESSIBLE TO THEM. [02:35:51.63] SO THE FACEBOOK EXAMPLE IS A [02:35:52.90] GREAT ONE. [02:35:53.60] PEOPLE WERE REALLY ANGRY THAT [02:35:55.63] THAT HAPPENED AND THEY HAD NO [02:35:57.20] IDEA THAT IT NOT ONLY DID BUT [02:35:59.07] COULD HAPPEN. [02:35:59.93] NOW, YOU MIGHT SAY, WELL, YOU [02:36:01.87] SHOULD KNOW IT COULD HAPPEN [02:36:02.97] BECAUSE IF YOU READ THE FINE [02:36:05.03] PRINT, IT WOULD SAY THAT, RIGHT? [02:36:07.10] IT'S NOT THAT WE DIDN'T GIVE YOU [02:36:08.73] THE OPPORTUNITY TO KNOW T IT'S [02:36:09.80] THAT YOU DIDN'T TAKE THE [02:36:11.10] OPPORTUNITY TO UNDERSTAND THAT. [02:36:13.37] OKAY. [02:36:13.60] THAT MAY BE TRUE. [02:36:14.53] BUT THEN YOU WOULDN'T KNOW YOU [02:36:15.73] WERE A PARTICIPANT. [02:36:17.57] SO NO ONE, I THINK, FEELS GOOD [02:36:19.17] ABOUT BEING AN UNWITTING [02:36:20.83] PARTICIPANT IN RESEARCH, WHICH [02:36:21.73] IS WHAT HAPPENED IN THAT TRIAL, [02:36:23.50] AND FACEBOOK SAID, WELL, IF WE [02:36:25.17] CAN'T DO THAT, WE CAN'T MAKE OUR [02:36:27.80] PRODUCT BETTER. [02:36:28.83] >> NO, AND I AGREE, AND I THINK [02:36:32.27] WE GO TO GREAT LENGTH TO SAY TRY [02:36:34.30] ON MAKE THE PERSON PARTICIPATE [02:36:37.30] CAN ALONG WITH THE CONSENT [02:36:39.23] PROCESS, MEANING IT GOES ON [02:36:40.40] THROUGHOUT THE WHOLE TRIAL, BUT [02:36:41.73] YEAH, IN THE END, I GUESS [02:36:43.80] SOMETIMES IN SOME SITUATIONS IT [02:36:45.30] FEELS THAT WAY, IT SEEMS THAT [02:36:46.67] WAY. [02:36:46.87] BUT YES, I MEAN, AT LEAST THEY [02:36:48.67] KNOW WHEN THEY'VE HAD A SAY HAD. [02:36:50.47] AND JUST ANOTHER COMMENT IN [02:36:52.83] TERMS OF THE BIG DATA, WHAT I [02:36:55.73] FIND TROUBLESOME TOO IS THAT THE [02:36:59.27] VERACITY OF THE DATA BECAUSE I [02:37:01.03] THINK THIS SELF-REPORTING ON [02:37:02.90] FACEBOOK, YOU KNOW, YOU PEOPLE [02:37:04.53] PUT ON THESE PERSONAS WHEN [02:37:06.50] THEY'RE ON FACEBOOK, BUT I THINK [02:37:08.20] SOMETIMES THEY'RE ACTUALLY MORE [02:37:10.10] TRUTHFUL, I'VE NEVER HAD A [02:37:13.03] FACEBOOK ACCOUNT AND I JUST [02:37:15.07] TOTALLY, YOU KNOW, DON'T LIKE [02:37:17.20] THAT, BUT I KNOW THAT FROM WHAT [02:37:18.40] I HEAR FROM FRIENDS, IT'S [02:37:20.77] ACTUALLY PEOPLE REALLY LET GO [02:37:22.07] BECAUSE THEY'RE NOT FACE TO [02:37:23.20] FACE, SO YOU MAY GET MORE [02:37:25.70] TRUTHFUL INFORMATION. [02:37:27.27] I DON'T KNOW. [02:37:28.07] >> JEFF KAHN: RIGHT. [02:37:29.43] IT'S HOW DO YOU VALIDATE THE [02:37:30.80] DATA, RIGHT? [02:37:32.20] THIS IS A PROBLEM IN ALL [02:37:34.07] RESEARCH. [02:37:34.33] AND I THINK PART OF WHAT THE [02:37:35.77] FOLKS WHO DO THIS RESEARCH WILL [02:37:37.57] TELL YOU IS THAT THEY ARE [02:37:38.97] WORKING REALLY HARD TO CLEAN [02:37:40.23] DATA SUCH THAT IT'S RELIABLE. [02:37:41.60] THEY DON'T WANT TO PRODUCE [02:37:44.87] RESEARCH THAT THE CONCLUSIONS [02:37:46.70] AREN'T AS THEY PREDICT. [02:37:49.80] SO IT'S A KIND OF VERSION OF A [02:37:53.10] PROBLEM THAT OTHER RESEARCHERS [02:37:54.27] HAVE HAD FOR A LONG TIME, BUT [02:37:56.07] WITH HUGE AMOUNTS OF DATA [02:37:57.37] POINTS. [02:37:57.60] THAT'S THE OTHER THING TO POINT [02:37:59.33] TO. [02:37:59.63] SO TWITTER, YOU KNOW, THERE ARE [02:38:02.53] TWO WAYS THAT PEOPLE CAN [02:38:03.80] RESEARCH TWITTER. [02:38:04.70] ONE IS CALLED THE API, WHICH IS [02:38:07.50] A SELECTION, SO TWITTER SELLS [02:38:09.73] ACCESS TO ITS DATA STREAM. [02:38:11.20] YOU CAN ACCESS A SLICE OF IT, [02:38:13.57] THINK OF IT AS A KIND OF FLOW [02:38:18.40] THAT YOU CAN GET A KIND OF SMALL [02:38:19.97] PART OF, WHICH IS SUPPOSED TO BE [02:38:21.53] REPRESENTATIVE OF SOMETHING, OR [02:38:22.33] YOU CAN HAVE WHAT THEY CALL THE [02:38:23.80] FIRE HOSE, WHICH IS LITERALLY [02:38:26.73] EVERYTHING. [02:38:27.03] BUT EVERYTHING IS HUGE AMOUNTS [02:38:29.27] OF DATA, RIGHT? [02:38:30.93] SO IT'S HUGE OF POWERFUL -- SO [02:38:34.63] IT'S HUGELY POWERFUL, BUT IT'S [02:38:37.53] INCREDIBLY DIFFERENT THING TO [02:38:39.40] WORK WITH THAN WHEN YOU HAVE 10 [02:38:41.23] PATIENTS IN A CANCER TRIAL. [02:38:42.43] IT'S LIKE APPLES AND ORANGES [02:38:43.90] REALLY. [02:38:44.13] >> THANK YOU. [02:38:44.60] >> JEFF KAHN: SURE. [02:38:51.23] >> SO I HAVE A QUESTION THAT I'M [02:38:52.97] SORT OF HANG UP ON. [02:38:53.97] A LOT OF YOUR IDEAS AND [02:38:55.70] PROPOSALS FOR THIS MAKE A LOT OF [02:38:57.00] SENSE AND ARE REALLY [02:38:58.07] INTERESTING, BUT I'M KIND OF [02:38:59.27] STUCK ON THE HOW DO WE MAKE THEM [02:39:01.40] CARE? [02:39:01.63] LIKE BOTH FROM A PERSPECTIVE OF [02:39:02.93] HOW DO WE AS A SOCIETY HOLD [02:39:05.13] FACEBOOK AND PLACES LIKE THIS [02:39:06.53] ACCOUNTABLE BUT ALSO KIND OF AS [02:39:08.43] A BIOETHICIST HOW DO YOU TALK TO [02:39:11.43] THIS CONSTITUENCY THAT MAYBE [02:39:12.77] DOESN'T COME TO MEETINGS LIKE [02:39:14.00] THIS AND ASK YOU ABOUT IT. [02:39:15.10] >> JEFF KAHN: YEAH, THAT SECOND [02:39:17.10] PART IS A GREAT QUESTION. [02:39:19.93] SO PART OF THE CHALLENGE IS [02:39:22.17] GETTING PEOPLE TO TALK ACROSS [02:39:25.00] THE BOUNDARIES IN WAYS THAT THEY [02:39:27.83] WANT TO BE THERE AND WE WANT TO [02:39:29.10] BE THERE. [02:39:29.77] I MEAN, WE WOULD WANT TO BE [02:39:33.47] THERE, BUT IT'S HOW DOES THAT [02:39:34.63] HAPPEN. [02:39:34.87] THE EXAMPLE I SHARED WITH YOU [02:39:35.87] ABOUT THE TWITTER RESEARCH [02:39:38.33] COMMUNITY TURNS OUT TO BE A KIND [02:39:39.73] OF EXAMPLE ABOUT THAT. [02:39:40.67] SO THEY DON'T WANT TO BEHAVE [02:39:42.57] BADLY, BUT THEY THINK OF WHAT [02:39:44.30] THEY'RE DOING IN A WAY THAT IS [02:39:45.73] DIFFERENT THAN PEOPLE WHO THINK [02:39:47.17] ABOUT RESEARCH PROTECTION HAVE [02:39:48.73] THOUGHT ABOUT IT. [02:39:50.00] SO THERE'S A KIND OF TWO-WAY [02:39:52.27] EDUCATION PROCESS THAT HAPPENS. [02:39:55.77] I THINK IT'S NOT JUST ABOUT [02:39:58.27] ETHICS AND RESEARCH AND THE WAY [02:39:59.90] FACEBOOK AND OTHERS BEHAVE, [02:40:02.10] WITHOUT PICKING ON FACEBOOK RS [02:40:03.50] GOOGLE, PICK WHATEVER COMPANY [02:40:06.47] YOU LIKE, AS WE HEAR IN OTHER [02:40:11.90] PARTS OF IS POLICY, THEY ARE A [02:40:14.87] BIT ROGUE-ISH, RIGHT, THEY ARE [02:40:16.67] SO BIG AND NOW INCREASINGLY [02:40:18.10] POWERFUL THAT THEY SORT OF SAY, [02:40:19.63] YOU KNOW, SORRY, WE'RE NOT GOING [02:40:21.13] TO DO THAT, WE DON'T NEED TO [02:40:23.03] AND, YOU KNOW, SORT OF GET OUT [02:40:24.27] OF THE WAY, WE HAVE PLANS, AND [02:40:27.67] GET ON BOARD OR DON'T, IT [02:40:29.77] DOESN'T MUCH MATTER TO US. [02:40:32.33] THE HAPPY THING, THERE IS, SO [02:40:34.03] HERE IS AN EXAMPLE OF A REALLY [02:40:36.63] GOOD AND IMPORTANT [02:40:38.20] COLLABORATION. [02:40:38.53] IT'S NOT EXACTLY IN THIS AREA, [02:40:40.07] BUT MAYBE IT WILL MAKE YOU FEEL [02:40:41.73] A LITTLE BIT BETTER. [02:40:42.67] THERE WAS AN ARTICLE WIDELY [02:40:44.30] REPORTED, I READ IT IN THE NEW [02:40:45.77] YORK TIMES, BUT IT WAS LOTS OF [02:40:47.30] PLACES, ABOUT A PROJECT THAT'S [02:40:48.67] LED OUT OF STANFORD BECAUSE [02:40:50.10] WE'RE TALKING SILICON VALLEY, [02:40:52.73] WHERE FOR THE NEXT 20 YEARS [02:40:55.90] EVERY 5 YEARS THERE WILL BE A [02:40:57.63] REPORT WRITTEN ABOUT [02:41:02.30] HUMAN-MACHINE INTERFACE AND THE [02:41:03.37] SOCIAL IMPLICATIONS. [02:41:05.27] SO IT'S SORT OF THINK OF [02:41:07.20] AUTONOMOUS MACHINES, RIGHT? [02:41:08.23] THERE WAS AN ARTICLE TODAY IN [02:41:09.87] THE NEW YORK TIMES TOLD YOU SAW [02:41:10.57] ABOUT THE MILITARY NOW HEADING [02:41:12.83] TOWARDS AUTONOMOUS BATTLEFIELD [02:41:15.87] DRONE KINDS OF THINGS. [02:41:17.20] SO IT'S STRAIGHT OUT OF SCI FI [02:41:19.93] MOVIES. [02:41:20.23] BUT THE INDUSTRY IS REALLY [02:41:22.33] WANTING TO TALK TO PEOPLE WHO [02:41:23.83] COME FROM QUITE DIVERSE AREAS, [02:41:27.00] PHILOSOPHERS, BEFORE HOW THEY [02:41:28.10] HAVE TO THINK ABOUT WHAT THEY'RE [02:41:30.73] PRODUCING AS WE'RE HEADING [02:41:31.87] TOWARDS A TIME WHEN IF YOU [02:41:34.53] REMEMBER READING ISAAC ASSAMOFF [02:41:38.37] IN HIGH HOOM, I-ROBOT, THE THREE LAWS [02:41:41.93] FOR WHAT ROBOTS HAVE TO DO TO BE [02:41:43.87] SAFE, THEY CAN'T HARM HUMANS, [02:41:45.10] THEY HAVE TO DO WHAT A HUMAN [02:41:46.13] SAYS UNLESS IT VIELTSES NUMBER [02:41:47.57] ONE AND I FORGET THE THIRD ONE, [02:41:49.43] THEY HAVE TO PROTECT THEMSELVES [02:41:50.90] UNLESS IT VIOLATES ONE AND TWO. [02:41:52.30] I JUST SAW THE MOVIE, THAT'S WHY [02:41:54.00] I CAN EVEN DO WHAT I JUST DID. [02:41:57.33] [LAUGHTER] [02:42:05.77] H SO THE INDUSTRY IS TALKING TO [02:42:08.00] PEOPLE THAT ARE FROM PLACES THAT [02:42:09.87] ARE MORE LIKE BIOETHICS AS YOU [02:42:12.97] CHARACTERIZED IT, BUT NOT FOR [02:42:14.17] THIS PURPOSE, SO THAT'S [02:42:15.73] CHALLENGE, AND I THINK THE [02:42:16.40] ANSWER IS THAT THEY ARE JUST [02:42:17.60] GOING TO CONSIDER WHAT THEY DO [02:42:21.00] BUSINESS PRACTICE, THEY'RE NOT [02:42:23.27] SURGERY TO THE RULES UNLESS THEY [02:42:24.90] WANT TO PUBLISH IN THE [02:42:26.20] BIOMEDICAL LITERATURE, AND THEY [02:42:27.20] DON'T CARE THAT MUCH, IT DOESN'T [02:42:28.50] HELP THEM, RIGHT, AND IF IT ONLY [02:42:30.37] BRINGS THEM BAD PR AND BAD [02:42:35.50] ARTICLE IN THE NEWS, WHY WOULD [02:42:36.40] THEY DO IT? [02:42:37.33] IT'S NOT A GOOD IDEA. [02:42:38.53] SO I THINK WHAT WE HAVE TO DO IS [02:42:40.07] FIGURE OUT A WAY TO SAY THIS IS [02:42:41.77] REALLY IMPORTANT AND INTERESTING [02:42:42.63] AND WE NEED TO BRING IT INTO THE [02:42:44.87] LIGHT IN A WAY THAT THEY CAN [02:42:47.33] LEARN WHAT THEY NEED TO LEARN IN [02:42:48.87] WAYS THAT EVERYBODY FEELS GOOD [02:42:52.10] ABOUT. [02:42:52.40] I DON'T MEAN GOOD LIKE MAKES ME [02:42:54.40] HAPPY, BUT GOOD LIKE I FEEL LIKE [02:42:55.90] THERE ARE APPROPRIATE RULES IN [02:42:57.53] PLACE. [02:42:57.73] I DON'T THINK THEY WANT TO BE [02:42:58.53] ROGUE, BUT I ALSO THINK THEY [02:43:00.07] FEEL LIKE THEY HAVE A BUSINESS [02:43:01.20] TO RUN AND THEY'RE NOT GOING TO [02:43:03.23] ENGAGE IN AREAS WHERE IT [02:43:06.43] CONSTRAINS THEIR ABILITY TO DO [02:43:07.53] THEIR BUSINESSES. [02:43:09.13] AND THAT'S KIND OF A NEW [02:43:12.23] PROBLEM. [02:43:12.47] I DIDN'T REALLY ANSWER YOUR [02:43:14.53] QUESTION, BUT -- THERE'S MORE [02:43:17.13] HAPPENING THAN YOU MIGHT THINK. [02:43:18.60] SO ONE MORE THING TO SAY. [02:43:19.90] SO ALL OF THE BIG PLAYERS IN [02:43:22.27] PRECISION MEDICINE NOW ARE [02:43:23.50] WORKING WITH ONE OF THE THREE, [02:43:25.93] GOOGLE, APPLE OR MICROSOFT, SO [02:43:29.17] YOU CAN'T DO PRECISION MEDICINE, [02:43:30.80] WHICH IS A BIG DATA ENTERPRISE, [02:43:32.93] WITHOUT THE INVOLVEMENT OF THE [02:43:34.80] TECHNOLOGY WORLD. [02:43:35.43] SO IT'S A DIFFERENT PART, RIGHT? [02:43:38.60] IT'S NOT -- FACEBOOK IN THAT [02:43:42.40] LIST, IT'S A BIGGER PART THAN [02:43:43.90] GOOGLE AND MICROSOFT AND APPLE [02:43:46.20] AND AND SOME OF THE THINGS WE'RE [02:43:48.17] TALKING ABOUT, THERE'S NOW [02:43:50.13] INCREASING OVERLAP, WHICH I [02:43:50.93] THINK IS A GOOD THING, SO THE [02:43:52.30] MORE WE DO TOGETHER I THINK WILL [02:43:53.83] MORE BECOME A CONVERSATION THAT [02:43:54.77] WE HAVE IN THESE OTHER AREAS TOO [02:43:56.17] ZEEF YOU A QUESTION FOR YOU. [02:43:58.13] >> I HAVE A QUESTION FOR YOU. [02:43:59.37] MAYBE N ON THE SAME SCALE AS -- [02:44:02.00] MAYBE NOT ON THE SAME SCALE AS [02:44:03.27] WHAT YOU WERE TALKING ABOUT, BUT [02:44:05.43] I'VE HEARD PEOPLE ARGUE THAT IN [02:44:07.13] ADDITION TO THE RULES DON'T [02:44:08.27] APPLY TO US, THERE'S A SELECTION [02:44:09.57] BIAS OR CONSENT BIAS THAT COULD [02:44:15.27] JEOPARDIZE THE VALIDITY OF THE [02:44:16.57] SCIENCE THAT THEY'RE DOING IF WE [02:44:17.67] WILL REQUIRE PEOPLE TO GET [02:44:20.50] CONSENT. [02:44:23.03] WHAT DO YOU THINK ABOUT THAT AND [02:44:24.80] HOW IT PULLS AGAINST OTHER [02:44:26.77] CONSIDERATION? [02:44:27.10] >> IF WE ONLY HAVE PEOPLE IN [02:44:29.67] RESEARCH WHO CONSENTS, WE'LL GET [02:44:31.03] AN ODD SUBSET? [02:44:32.00] >> RIGHT. [02:44:32.33] >> IT'S PROBABLY RIGHT. [02:44:33.37] WE HAVE TO FIGURE OUT A WAY THAT [02:44:34.97] PEOPLE AT LEAST UNDERSTAND THAT [02:44:35.93] THEY CAN BE RESEARCH SUBJECTS [02:44:38.00] POTENTIALLY, SO MAYBE THAT -- [02:44:41.17] THERE ARE EMPIRICAL WAYS TO TEST [02:44:43.07] THAT HYPOTHESIS. [02:44:44.27] SO MAYBE YOU COMPARE OPT IN [02:44:46.27] VERSUS OPT OUT AND SEE WHAT THAT [02:44:48.67] DOES TO THE RESEARCH SUBJECT [02:44:53.13] POPULATION POOL, RIGHT? [02:44:54.07] THE GOOD NEWS IS THAT THERE'S SO [02:44:55.80] MUCH ACTIVITY, THERE'S SO MANY [02:44:58.40] PEOPLE WHO LIVE IN THIS AREA, [02:45:00.63] USE THESE THINGS, THAT YOU COULD [02:45:01.67] DO THIS KIND OF STUFF RELATIVELY [02:45:03.57] EASILY. [02:45:03.83] >> PRETTY EASILY. [02:45:04.90] >> THERE'S, YOU KNOW, WHAT'S IT [02:45:06.70] CALLED, WHERE YOU CAN PAY A [02:45:07.80] LITTLE BIT TO PEOPLE TO DO [02:45:11.80] RESEARCH FOR YOU. [02:45:13.90] >> M MANY TURK. [02:45:19.30] >> MECHANICAL TURK. [02:45:20.90] THERE ARE LOTS OF WAYS YOU CAN [02:45:21.80] SET UP FOR RELATIVELY LOW COST [02:45:23.73] TO DO IT PRETTY QUICKLY, DO SOME [02:45:27.63] OF THESE EMPIRICAL ASSESS. [02:45:29.13] I THINK THERE'S LOTS OF [02:45:30.27] OPPORTUNITIES HERE BUT WE HAVE [02:45:31.00] TO DO SOMETHING, I THINK WE [02:45:36.03] CAN'T PRETEND THESE AREN'T [02:45:38.17] ISSUES. [02:45:38.40] I THINK ONE OF THE REALLY BIG [02:45:39.53] PROBLEMS IS THE DIFFERENCE IN [02:45:40.60] POLICY ORIENTATION BETWEEN [02:45:41.23] WHAT'S HAPPENING IN EUROPE AND [02:45:42.43] WHAT'S HAPPENING HERE. [02:45:43.53] WE'RE NOT PAYING MUCH ATTENTION [02:45:44.80] TO THIS. [02:45:45.50] PEOPLE WHO DON'T LIVE REALLY IN [02:45:46.97] THAT WORLD. [02:45:48.13] SO IN EUROPE NOW THROUGH THE EU, [02:45:50.17] YOU HAVE THE RIGHT TO BE [02:45:51.80] FORGOTTEN FROM THE INTERNET, [02:45:54.23] WHICH MEANS THEY HAVE NOW [02:45:56.43] REQUIRED IF YOU SAY I DON'T WANT [02:45:57.40] TO HAVE ANY INFORMATION ABOUT ME [02:46:02.60] MINED BY GOOGLE ANYMORE, THEY [02:46:03.63] HAVE TO BE ABLE TO PULL STUFF [02:46:06.30] ABOUT YOU OUT, WHOEVER THE THEY [02:46:07.77] IS IN THAT SENTENCE. [02:46:09.03] THAT'S REALLY HARD. [02:46:10.07] AND THAT'S CONTRA, RIGHT, THAT'S [02:46:11.83] IN A WAY TOTALLY CONFLICTING [02:46:14.27] WITH THE WAY THAT THE U.S. HAS [02:46:16.03] SET UP ITS THINKING ABOUT WHAT [02:46:17.93] THE INTERNET IS AND WHAT IT'S [02:46:20.57] FOR. [02:46:20.77] SO THAT'S A KIND OF BASIC [02:46:23.73] FOUNDATIONAL THING THAT'S GOING [02:46:24.70] TO HAVE TO GET FIGURED OUT [02:46:26.63] BECAUSE, YOU KNOW, DATA ABOUT [02:46:27.87] PEOPLE IS SORT OF WHAT THE [02:46:30.37] FUTURE CLEARLY IS GOING TO BE [02:46:31.83] ABOUT IN LARGE PART. [02:46:35.30] >> Christine Grady: OTHER [02:46:35.87] QUESTIONS OR COMMENTS? [02:46:36.90] ALL RIGHT. [02:46:38.10] THANK YOU SO MUCH, JEFF. [02:46:40.00] >> JEFF KAHN: SURE. [02:46:41.80] THANK YOU. [02:46:42.93] [APPLAUSE] [02:46:45.10]