1 00:00:05,642 --> 00:00:07,144 WELCOME EVERYONE TO SESSION 4 OF 2 00:00:07,144 --> 00:00:10,280 ETHICAL AND REGULATORY ASPECTS 3 00:00:10,280 --> 00:00:11,982 OF CLINICAL RESEARCH. 4 00:00:11,982 --> 00:00:13,884 IT'S HARD TO BELIEVE WE ARE 5 00:00:13,884 --> 00:00:15,686 HALFWAY THROUGH THE COURSE. 6 00:00:15,686 --> 00:00:18,088 TODAY WE HAVE TWO GUEST 7 00:00:18,088 --> 00:00:18,355 SPEAKERS. 8 00:00:18,355 --> 00:00:21,125 OUR FIRST GUEST SPEAKER IS FROM 9 00:00:21,125 --> 00:00:23,527 OUR DEPARTMENT HERE AT THE NIH 10 00:00:23,527 --> 00:00:25,796 THE DEPARTMENT OF BIOETHICS, 11 00:00:25,796 --> 00:00:28,032 YUKIKO ASADA. 12 00:00:28,032 --> 00:00:30,868 SHE JOINED RELATIVELY RECENTLY 13 00:00:30,868 --> 00:00:33,237 IN 2002 AND HER EXPERTISE IS IN 14 00:00:33,237 --> 00:00:35,506 POPULATION HEALTH AND 15 00:00:35,506 --> 00:00:37,908 SPECIFICALLY TO MAKE EXPLICIT 16 00:00:37,908 --> 00:00:39,243 THE IMPLICIT ASSUMPTIONS 17 00:00:39,243 --> 00:00:40,844 UNDERLYING THE QUANTITATIVE 18 00:00:40,844 --> 00:00:43,414 METHODS SHE USES AND OTHERS USE 19 00:00:43,414 --> 00:00:44,448 IN POPULATION HEALTH RESEARCH. 20 00:00:44,448 --> 00:00:46,984 AND JUST A QUICK REMINDER, ALL 21 00:00:46,984 --> 00:00:50,721 THE FULL BIOS OF THE DEPARTMENT 22 00:00:50,721 --> 00:00:53,991 FACULTY ARE ONLINE AND BIOS FOR 23 00:00:53,991 --> 00:00:56,760 ALL GUESTS ARE POSTED WITH EACH 24 00:00:56,760 --> 00:00:57,494 MODULE. 25 00:00:57,494 --> 00:01:00,931 WITH THAT I'LL HAND IT OVER TO 26 00:01:00,931 --> 00:01:01,165 YUKIKO. 27 00:01:01,165 --> 00:01:05,903 >> OKAY. 28 00:01:05,903 --> 00:01:06,437 GOOD MORNING. 29 00:01:06,437 --> 00:01:16,880 AND THANK YOU VERY MUCH . 30 00:01:17,748 --> 00:01:19,883 MY TALK IS THE USUAL DISCLAIMER. 31 00:01:19,883 --> 00:01:20,951 I PRESENT MY VIEW AND NO ONE 32 00:01:20,951 --> 00:01:24,421 ELSE. 33 00:01:24,421 --> 00:01:28,292 SO THIS TALK, THE FOCUS IS IN 34 00:01:28,292 --> 00:01:32,596 EQUITY AND DESIGN AND CONDUCT OF 35 00:01:32,596 --> 00:01:33,797 CLINICAL RESEARCH. 36 00:01:33,797 --> 00:01:35,799 SO, HERE WHEN I SAY CLINICAL 37 00:01:35,799 --> 00:01:39,903 RESEARCH I USE THE TERM BROADLY. 38 00:01:39,903 --> 00:01:42,272 SO ANYTHING TO DO WITH HUMAN 39 00:01:42,272 --> 00:01:43,907 HEALTH. 40 00:01:43,907 --> 00:01:47,411 I GIVE A LOT OF EXAMPLE OF THE 41 00:01:47,411 --> 00:01:48,212 INTERVENTION STUDIES AND 42 00:01:48,212 --> 00:01:50,114 CLINICAL TRIALS. 43 00:01:50,114 --> 00:01:52,749 WHAT I TALK ABOUT TODAY REALLY 44 00:01:52,749 --> 00:01:56,353 APPLIES TO ANY OTHER KIND OF 45 00:01:56,353 --> 00:01:57,020 OBSERVATIONAL STUDIES AND OTHER 46 00:01:57,020 --> 00:02:00,357 DESIGNS TOO. 47 00:02:00,357 --> 00:02:02,693 AND IT'S NOT JUST THAT MEDICINE 48 00:02:02,693 --> 00:02:05,696 PER SE IT COULD BE -- YOU CAN 49 00:02:05,696 --> 00:02:08,098 EXTEND THE DISCUSSION TO SOCIAL 50 00:02:08,098 --> 00:02:10,200 BEHAVIORAL RESEARCH TOO. 51 00:02:10,200 --> 00:02:11,068 AND THEN I WANT TO MAKE TWO 52 00:02:11,068 --> 00:02:19,009 POINTS. 53 00:02:19,009 --> 00:02:21,912 FIRST IS THE EQUITY 54 00:02:21,912 --> 00:02:23,380 CONSIDERATIONS ARE NOT A CHECK 55 00:02:23,380 --> 00:02:23,780 BOX. 56 00:02:23,780 --> 00:02:25,482 THEY'RE WOVEN INTO PRINCIPLES 57 00:02:25,482 --> 00:02:31,088 FOR ETHICAL CLINICAL RESEARCH. 58 00:02:31,088 --> 00:02:33,157 I SUPPOSE YOU'RE QUITE FAMILIAR 59 00:02:33,157 --> 00:02:35,559 WITHIN THE EIGHT PRINCIPLES FOR 60 00:02:35,559 --> 00:02:36,927 ETHICAL, CLINICAL RESEARCH. 61 00:02:36,927 --> 00:02:40,831 SO WHEN I SAY EQUITY, IT'S NOT 62 00:02:40,831 --> 00:02:44,701 LIKE I WANT TO ADD ONE MORE 63 00:02:44,701 --> 00:02:50,841 CONSTELLATION TO THE EIGHT. 64 00:02:50,841 --> 00:02:54,444 IT'S MORE LIKE FOR EVERYONE ONE 65 00:02:54,444 --> 00:02:57,481 OF THEM YOU HAVE ETHICAL 66 00:02:57,481 --> 00:02:57,848 CONSIDERATIONS. 67 00:02:57,848 --> 00:03:00,651 THE INTERESTING THING IS IT'S 68 00:03:00,651 --> 00:03:02,953 NOT A CHECK BOX, WHICH MEANS 69 00:03:02,953 --> 00:03:06,223 IT'S NOT LIKE OKAY FOR THIS ONE 70 00:03:06,223 --> 00:03:06,857 PRINCIPLE. 71 00:03:06,857 --> 00:03:10,027 THERE'S AN ETHICS CONSIDERATION, 72 00:03:10,027 --> 00:03:11,061 CHECK, ANOTHER ONE, CHECK. 73 00:03:11,061 --> 00:03:12,362 IT'S NOT THAT SIMPLE. 74 00:03:12,362 --> 00:03:16,233 SO IF YOU THINK ABOUT ETHICAL 75 00:03:16,233 --> 00:03:17,501 CONSIDERATIONS IN ONE, THAT 76 00:03:17,501 --> 00:03:19,169 MIGHT LEAD TO THE OTHER 77 00:03:19,169 --> 00:03:19,436 PRINCIPLE. 78 00:03:19,436 --> 00:03:23,941 SO IT'S KIND OF WOVEN IN. 79 00:03:23,941 --> 00:03:25,909 AND TODAY BECAUSE OF THE 80 00:03:25,909 --> 00:03:31,715 CONSIDERATIONS AND I FOCUSSED ON 81 00:03:31,715 --> 00:03:32,583 THESE THREE. 82 00:03:32,583 --> 00:03:35,519 AND SECOND POINT I WANT TO MAKE 83 00:03:35,519 --> 00:03:37,921 IS THE BOTTOM ONE TO MAKE EQUITY 84 00:03:37,921 --> 00:03:40,157 CONSIDERATIONS EXPLICIT AND 85 00:03:40,157 --> 00:03:40,524 MEANINGFUL. 86 00:03:40,524 --> 00:03:44,828 IT'S IMPORTANT TO THINK 87 00:03:44,828 --> 00:03:49,900 CAREFULLY ABOUT WHEN HEALTH 88 00:03:49,900 --> 00:03:50,434 INEQUALITIES ARE UNFAIR. 89 00:03:50,434 --> 00:03:52,536 SO WHAT TO I MEAN? 90 00:03:52,536 --> 00:03:53,136 I HOPE IT BECOMES CLEAR AS I 91 00:03:53,136 --> 00:03:56,540 TALK. 92 00:03:56,540 --> 00:03:58,976 SO TODAY, THIS TALK IS GUIDED BY 93 00:03:58,976 --> 00:04:00,944 THREE QUESTIONS. 94 00:04:00,944 --> 00:04:01,778 FIRST, WHO SHOULD BE IN THE 95 00:04:01,778 --> 00:04:07,451 STUDY AND WHY. 96 00:04:07,451 --> 00:04:08,885 SECOND, WHICH INEQUALITIES ARE 97 00:04:08,885 --> 00:04:14,791 UNFAIR AND ALIVE AND FINALLY HOW 98 00:04:14,791 --> 00:04:16,193 DO EQUITY CONSIDERATIONS 99 00:04:16,193 --> 00:04:17,327 INFLUENCE THE STUDY DESIGN AND 100 00:04:17,327 --> 00:04:24,501 ANALYSIS PLAN AND REPORTING? 101 00:04:24,501 --> 00:04:26,136 IT'S A QUESTION IT'S NOT LIKE A 102 00:04:26,136 --> 00:04:29,139 CLEAR ANSWER AND YOU CAN 103 00:04:29,139 --> 00:04:29,840 MINIMALIZE IT AND ANSWER MANY 104 00:04:29,840 --> 00:04:32,776 AND YOU HAVE TO PICK. 105 00:04:32,776 --> 00:04:34,678 IT'S NOT LIKE AN EASY BUT I HOPE 106 00:04:34,678 --> 00:04:40,017 BY THE END OF THIS TALK I CAN 107 00:04:40,017 --> 00:04:40,651 CONVINCE YOU IT'S IMPORTANT TO 108 00:04:40,651 --> 00:04:46,990 EXAMINE THE QUESTIONS. 109 00:04:46,990 --> 00:04:47,624 SO, LET'S START. 110 00:04:47,624 --> 00:04:50,927 WHO SHOULD BE IN THE STUDY AND 111 00:04:50,927 --> 00:04:52,229 THE REASON I THINK THERE ARE 112 00:04:52,229 --> 00:04:56,600 THREE WE CAN THINK ABOUT. 113 00:04:56,600 --> 00:04:57,167 PARTICIPATION, BIOLOGY AND 114 00:04:57,167 --> 00:04:57,968 SOCIETAL CONCERN. 115 00:04:57,968 --> 00:05:03,840 AND I'LL GO ONE BY ONE. 116 00:05:03,840 --> 00:05:05,976 THE FIRST, PARTICIPATION IS 117 00:05:05,976 --> 00:05:07,911 PROBABLY FAMILIAR TO YOU FROM 118 00:05:07,911 --> 00:05:08,945 PREVIOUS LECTURES. 119 00:05:08,945 --> 00:05:11,348 SO CONSIDERATION HERE IS THE 120 00:05:11,348 --> 00:05:14,918 FAIR DISTRIBUTION OF BENEFITS 121 00:05:14,918 --> 00:05:16,019 AND BURDEN. 122 00:05:16,019 --> 00:05:17,220 SO, AS YOU PROBABLY ALREADY 123 00:05:17,220 --> 00:05:18,922 HEARD WHAT IT MEANS TO 124 00:05:18,922 --> 00:05:20,490 PARTICIPATE IN STUDIES HAS 125 00:05:20,490 --> 00:05:23,560 CHANGED FROM BEARING THE BURDEN 126 00:05:23,560 --> 00:05:26,830 TO ACCESSING TO INNOVATIONS. 127 00:05:26,830 --> 00:05:31,935 IT USED TO BE THE PARTICIPATION 128 00:05:31,935 --> 00:05:37,407 IN THE CLINICAL TRIALS IS A 129 00:05:37,407 --> 00:05:46,750 SPECIAL THING THAT AND NOW IT 130 00:05:46,750 --> 00:05:47,517 SHIFTED THE DEFAULT IS 131 00:05:47,517 --> 00:05:50,053 EVERYTHING SHOULD BE ABLE TO 132 00:05:50,053 --> 00:05:54,224 PARTICIPATE AND IF YOU EXCLUDE 133 00:05:54,224 --> 00:05:56,927 THEM YOU NEED JUSTIFICATION. 134 00:05:56,927 --> 00:06:01,298 IT'S QUITE INTERESTING HISTORY 135 00:06:01,298 --> 00:06:06,570 OF HOW AND THAT COULD BE ONE 136 00:06:06,570 --> 00:06:12,976 REASON WHY YOU WANT TO INVOLVE 137 00:06:12,976 --> 00:06:15,746 DIVERSE POPULATION IN YOUR STUDY 138 00:06:15,746 --> 00:06:19,049 AND DISTRIBUTION OF BURD SKREN. 139 00:06:19,049 --> 00:06:20,317 THAT'S NOT THE ONLY REASON WHY 140 00:06:20,317 --> 00:06:21,418 YOU MAY WANT TO THINK OF OTHER 141 00:06:21,418 --> 00:06:24,888 PEOPLE IN YOUR STUDY. 142 00:06:24,888 --> 00:06:28,759 HERE I GIVE YOU BIOLOGY AND 143 00:06:28,759 --> 00:06:31,561 SOCIETAL CONCERN. 144 00:06:31,561 --> 00:06:33,663 FOR BIOLOGY, YOU ARE INTERESTED 145 00:06:33,663 --> 00:06:38,702 IN YOUR STUDY, SOME CAUSAL 146 00:06:38,702 --> 00:06:42,606 RELATIONSHIP X CAUSES Y AND YOU 147 00:06:42,606 --> 00:06:45,075 MIGHT BELIEVE FOR WHATEVER 148 00:06:45,075 --> 00:06:47,444 REASON THE CAUSALITY MAY WORK 149 00:06:47,444 --> 00:06:49,246 DIFFERENTLY IN DIFFERENT GROUPS 150 00:06:49,246 --> 00:06:51,848 OF HUMAN BEINGS BECAUSE OF 151 00:06:51,848 --> 00:06:52,349 BIOLOGICAL DIFFERENCES. 152 00:06:52,349 --> 00:06:55,886 HERE I WANT TO GIVE AN EXAMPLE 153 00:06:55,886 --> 00:06:56,520 OF THE CARDIOVASCULAR DISEASE BY 154 00:06:56,520 --> 00:07:04,227 SEX. 155 00:07:04,227 --> 00:07:07,898 THESE ARE INFO GRAPHICS FROM THE 156 00:07:07,898 --> 00:07:10,100 AMERICAN HEART ASSOCIATION. 157 00:07:10,100 --> 00:07:10,801 AND HEART ATTACK SYMPTOMS 158 00:07:10,801 --> 00:07:16,139 BETWEEN MEN AND WOMEN. 159 00:07:16,139 --> 00:07:20,944 THIS IS NOW MEN AND WOMEN HAVE A 160 00:07:20,944 --> 00:07:21,812 QUITE DIFFERENT SYMPTOMS OF 161 00:07:21,812 --> 00:07:22,345 HEART ATTACK. 162 00:07:22,345 --> 00:07:31,888 YOU CAN SEE I DON'T GO OVER 163 00:07:31,888 --> 00:07:34,157 DETAILS AND YOU CAN MEASURE IF 164 00:07:34,157 --> 00:07:36,927 YOU JUST STUDY MEN YOU MISS 165 00:07:36,927 --> 00:07:47,370 WHAT'S HAPPENING IN WOMEN. 166 00:07:49,940 --> 00:07:52,309 BIOLOGICAL MECHANISMS CAN BE 167 00:07:52,309 --> 00:07:53,810 DIFFERENT AND THESE ARE STUDIES 168 00:07:53,810 --> 00:07:56,079 I WON'T GO INTO THE DETAILS 169 00:07:56,079 --> 00:07:59,015 BECAUSE IT'S NOT THE MEDICAL 170 00:07:59,015 --> 00:08:08,091 TALK BUT SHOWS PROBABLY THERE'S 171 00:08:08,091 --> 00:08:09,893 AND WE'RE TALKING ABOUT EXACTLY 172 00:08:09,893 --> 00:08:12,963 THE SAME DISEASE. 173 00:08:12,963 --> 00:08:15,031 HOW THAT MANIFESTS IN THE BODY 174 00:08:15,031 --> 00:08:16,533 IS BIO LOGICALLY DIFFERENT 175 00:08:16,533 --> 00:08:18,301 BETWEEN MEN AND WOMEN. 176 00:08:18,301 --> 00:08:21,505 SO THAT IS A GOOD REASON TO 177 00:08:21,505 --> 00:08:24,541 SUSPECT THAT WE CANNOT JUST 178 00:08:24,541 --> 00:08:25,876 STUDY MEN, WHICH WE 179 00:08:25,876 --> 00:08:27,477 TRADITIONALLY DID. 180 00:08:27,477 --> 00:08:28,645 WE MIGHT MISS A LOT OF THINGS 181 00:08:28,645 --> 00:08:32,516 AND WE CANNOT SAY THAT CAUSAL 182 00:08:32,516 --> 00:08:34,584 RELATIONSHIP GENERALIZED TO 183 00:08:34,584 --> 00:08:34,784 WOMEN. 184 00:08:34,784 --> 00:08:36,453 SO THERE'S A GOOD REASON YOU 185 00:08:36,453 --> 00:08:37,053 SHOULD STUDY BOTH OF THESE 186 00:08:37,053 --> 00:08:39,055 GROUPS. 187 00:08:39,055 --> 00:08:44,995 IT'S JUST ONE OF THE EXAMPLES OF 188 00:08:44,995 --> 00:08:45,962 BIOLOGY DRIVES YOUR INTEREST TO 189 00:08:45,962 --> 00:08:51,268 HAVE DIFFERENT PEOPLE IN YOUR 190 00:08:51,268 --> 00:08:53,570 STUDY. 191 00:08:53,570 --> 00:08:55,639 ANOTHER ONE IS THE SOCIETAL 192 00:08:55,639 --> 00:08:55,872 CONCERN. 193 00:08:55,872 --> 00:08:57,674 HERE WE MAY BE INTERESTED IN THE 194 00:08:57,674 --> 00:09:00,410 CAUSAL RELATIONSHIP. 195 00:09:00,410 --> 00:09:03,747 YOU MIGHT EXPECT WITHIN THAT 196 00:09:03,747 --> 00:09:07,250 RELATIONSHIP WORKS DIFFERENTLY 197 00:09:07,250 --> 00:09:09,452 FOR DIFFERENT KINDS OF PEOPLE 198 00:09:09,452 --> 00:09:12,956 BECAUSE HOW WE ORGANIZE OUR 199 00:09:12,956 --> 00:09:14,224 SOCIETY. 200 00:09:14,224 --> 00:09:16,626 ONE WAY TO THINK ABOUT THIS IS 201 00:09:16,626 --> 00:09:19,396 ANOTHER MIGHT BE DIFFERENTIAL 202 00:09:19,396 --> 00:09:20,964 INTERVENTION AFFECTS BY SOCIAL 203 00:09:20,964 --> 00:09:25,468 GROUP CHARACTERISTICS. 204 00:09:25,468 --> 00:09:27,938 SO HERE EXAMPLE IS THE EFFECTS 205 00:09:27,938 --> 00:09:31,041 OF WOMEN'S GROUP PARTICIPATION 206 00:09:31,041 --> 00:09:35,445 ON NEONATAL MORTALITY RATE BY 207 00:09:35,445 --> 00:09:35,812 MARGINALIZATION. 208 00:09:35,812 --> 00:09:36,947 LET ME EXPLAIN MORE. 209 00:09:36,947 --> 00:09:39,816 THIS IS TAKEN FROM META-ANALYSIS 210 00:09:39,816 --> 00:09:42,719 AND MANY COUNTRIES FOCUSSED AND 211 00:09:42,719 --> 00:09:46,222 I'M JUST FOCUSSING ON ONE 212 00:09:46,222 --> 00:09:46,456 COUNTRY. 213 00:09:46,456 --> 00:09:49,893 SO INTERVENTION IS PREGNANT 214 00:09:49,893 --> 00:09:57,500 WOMEN IN NEPAL PARTICIPATED AND 215 00:09:57,500 --> 00:09:58,702 THE COMPARISON IS WITH AND 216 00:09:58,702 --> 00:10:02,739 WITHOUT THE INTERVENTION. 217 00:10:02,739 --> 00:10:05,809 OUTCOME WE'RE INTERESTED IS THE 218 00:10:05,809 --> 00:10:07,010 NEONATAL MORTALITY FROM THE 219 00:10:07,010 --> 00:10:08,945 BABIES OF THE WOMEN WHO 220 00:10:08,945 --> 00:10:12,382 PARTICIPATED OR NOT PARTICIPATED 221 00:10:12,382 --> 00:10:13,817 IN THE INTERVENTION. 222 00:10:13,817 --> 00:10:16,753 AND HERE THE INVESTIGATOR FELT 223 00:10:16,753 --> 00:10:19,022 THAT MAYBE THIS INTERVENTION 224 00:10:19,022 --> 00:10:21,591 HAVE A DIFFERENT EFFECT 225 00:10:21,591 --> 00:10:24,260 DEPENDING ON THE DEGREE OF 226 00:10:24,260 --> 00:10:25,595 MARGINALIZATION. 227 00:10:25,595 --> 00:10:28,465 HERE IN THIS STUDY, 228 00:10:28,465 --> 00:10:33,003 MARGINALIZATION IS DEFINED WITH 229 00:10:33,003 --> 00:10:35,705 THE LITERACY. 230 00:10:35,705 --> 00:10:41,077 SO MOST ARE WOMEN MANY 231 00:10:41,077 --> 00:10:45,181 ILLITERATE AND POOR. 232 00:10:45,181 --> 00:10:55,692 SO THE RIGHT-HAND SIDE -- AND 233 00:10:56,092 --> 00:11:02,298 YOU SEE ON THE VERTICAL LINE THE 234 00:11:02,298 --> 00:11:03,466 NEONATAL MORTALITY RATE. 235 00:11:03,466 --> 00:11:04,801 GOING UP HIGHER IS THE MORTALITY 236 00:11:04,801 --> 00:11:06,002 RATE WHICH IS NOT GOOD. 237 00:11:06,002 --> 00:11:08,938 YOU WANT TO BE LOWER. 238 00:11:08,938 --> 00:11:12,742 AND YOU SEE YEAR ONE AND THEN 239 00:11:12,742 --> 00:11:12,909 TWO. 240 00:11:12,909 --> 00:11:16,112 SO HERE WE SEE FOR THE CONTROL 241 00:11:16,112 --> 00:11:20,150 GROUP THE INTERVENTION WORKS FOR 242 00:11:20,150 --> 00:11:22,585 THE YEAR 1 AND 2 BECAUSE THE 243 00:11:22,585 --> 00:11:23,920 SOLID LINE IS LOWER THAN THE 244 00:11:23,920 --> 00:11:24,921 DOTTED LINE. 245 00:11:24,921 --> 00:11:27,390 INTERESTINGLY FOR THE 246 00:11:27,390 --> 00:11:29,059 MARGINALIZED GROUP IF YOU LOOK 247 00:11:29,059 --> 00:11:31,895 AT JUST THE FIRST YEAR THERE 248 00:11:31,895 --> 00:11:33,730 DOESN'T SEEM TO BE INTERVENTION 249 00:11:33,730 --> 00:11:39,502 EFFECT BUT YEAR TWO IS A BIG 250 00:11:39,502 --> 00:11:47,177 DIFFERENCE. 251 00:11:47,177 --> 00:11:48,511 YOU WOULDN'T DESIGN THE STUDY 252 00:11:48,511 --> 00:11:50,947 AND WOULD TOTALLY MISS THAT. 253 00:11:50,947 --> 00:11:52,849 THAT'S ONE WAY TO KIND OF THINK, 254 00:11:52,849 --> 00:11:54,451 OKAY, WHEN I DESIGN THE STUDY, 255 00:11:54,451 --> 00:11:56,820 MAYBE I NEED TO INCLUDE 256 00:11:56,820 --> 00:11:58,755 DIFFERENT KINDS OF WOMEN BASED 257 00:11:58,755 --> 00:12:00,790 ON THE MARGINALIZATION BECAUSE I 258 00:12:00,790 --> 00:12:01,624 EXPECT THIS. 259 00:12:01,624 --> 00:12:04,627 RIGHT, SO THAT'S ONE WAY. 260 00:12:04,627 --> 00:12:08,331 THE OTHER IS THE BOTTOM ONE. 261 00:12:08,331 --> 00:12:11,301 SO YOU MIGHT EXPECT THE 262 00:12:11,301 --> 00:12:12,602 DIFFERENTIAL EFFECTS WITHIN THE 263 00:12:12,602 --> 00:12:15,739 TRADITIONALLY EXCLUDED GROUPS. 264 00:12:15,739 --> 00:12:17,507 SO HERE I WANT TO GIVE AN 265 00:12:17,507 --> 00:12:19,909 EXAMPLE OF THE EFFECTS OF THE 266 00:12:19,909 --> 00:12:23,346 HIGH INTENSITY LIFESTYLE-BASED 267 00:12:23,346 --> 00:12:24,981 PROGRAM FOR OBESITY TREATMENT UP 268 00:12:24,981 --> 00:12:27,617 PRIMARY CARE CLINICS IN 269 00:12:27,617 --> 00:12:28,451 LOW-INCOME NEIGHBORHOODS. 270 00:12:28,451 --> 00:12:30,854 NOW WE'RE JUST FOCUSSING ON 271 00:12:30,854 --> 00:12:32,689 TRADITIONALLY EXCLUDED GROUPS 272 00:12:32,689 --> 00:12:33,189 WHICH IS THE LOW INCOME 273 00:12:33,189 --> 00:12:43,433 NEIGHBORHOOD. 274 00:12:46,302 --> 00:12:47,036 AND LOW INCOME NEIGHBORHOOD AND 275 00:12:47,036 --> 00:12:50,306 THE INTERVENTION IS THE 276 00:12:50,306 --> 00:12:52,609 HIGH-INCOME CITY. 277 00:12:52,609 --> 00:12:56,146 LIFESTYLE BASED FOR OBESITY AND 278 00:12:56,146 --> 00:12:59,315 THINGS THAT INCLUDE DIET, 279 00:12:59,315 --> 00:13:00,850 NUTRITION, ADVICE AND PHYSICAL 280 00:13:00,850 --> 00:13:03,920 EXERCISE PROGRAMS AND ALL THOSE 281 00:13:03,920 --> 00:13:04,921 THINGS COMBINED. 282 00:13:04,921 --> 00:13:07,891 COMPARISON IS THE INTENSIVE 283 00:13:07,891 --> 00:13:08,992 PROGRAM AND USUAL CARE. 284 00:13:08,992 --> 00:13:11,795 USUAL CARE COULD BE DOCTOR'S 285 00:13:11,795 --> 00:13:12,362 ADVICE. 286 00:13:12,362 --> 00:13:16,933 THEY'RE NOT IN AN INTERVENTION 287 00:13:16,933 --> 00:13:17,734 PROGRAM. 288 00:13:17,734 --> 00:13:18,968 OUTCOME IS THE EVALUATE. 289 00:13:18,968 --> 00:13:22,572 MAJOR FINDINGS IS IN TWO YEARS 290 00:13:22,572 --> 00:13:24,941 HOW MUCH BODY WEIGHT CHANGE. 291 00:13:24,941 --> 00:13:29,779 SO HERE YOU SEE THE INTENSIVE 292 00:13:29,779 --> 00:13:31,447 LIFESTYLE GROUP HAD THE BIGGEST 293 00:13:31,447 --> 00:13:32,916 AMOUNT OF WEIGHT LOSS. 294 00:13:32,916 --> 00:13:43,326 IT SEEMS TO BE WORKING. 295 00:13:54,204 --> 00:13:59,609 AND THESE ARE GOOD RESULTS. 296 00:13:59,609 --> 00:14:01,010 THEN YOU MIGHT IMAGINE LOW 297 00:14:01,010 --> 00:14:08,918 INCOME NEIGHBORHOODS SHARE ON 298 00:14:08,918 --> 00:14:12,956 ONIST -- SHARE LOW INCOME. 299 00:14:12,956 --> 00:14:15,258 THE STUDY AUTHORS ASK HOW ABOUT 300 00:14:15,258 --> 00:14:20,029 BY RACE. 301 00:14:20,029 --> 00:14:21,764 IN THIS NEIGHBORHOOD THERE'S 302 00:14:21,764 --> 00:14:22,932 BLACK AND NON-BLACK PEOPLE AND 303 00:14:22,932 --> 00:14:24,934 ARE THERE DIFFERENCES? 304 00:14:24,934 --> 00:14:28,705 YES, THEY FIND A DIFFERENCE. 305 00:14:28,705 --> 00:14:32,942 HERE YOU SEE THE SOLID LINE IN 306 00:14:32,942 --> 00:14:38,348 THIS GRAPH AND DOTTED LINE AND 307 00:14:38,348 --> 00:14:41,417 FOR BOTH INTERVENTION GROUPS IT 308 00:14:41,417 --> 00:14:41,851 WORKS. 309 00:14:41,851 --> 00:14:47,023 INTERESTINGLY AND UNFORTUNATELY 310 00:14:47,023 --> 00:14:49,726 THE EFFECT OF INTERVENTION IS A 311 00:14:49,726 --> 00:14:50,493 BIT LESS FOR BLACK POPULATION 312 00:14:50,493 --> 00:14:54,497 THAN THE OTHER RACE. 313 00:14:54,497 --> 00:15:00,036 SO IF YOU DESIGN THIS WAY YOU 314 00:15:00,036 --> 00:15:09,112 COULD TEASE OUT THE 315 00:15:09,112 --> 00:15:09,445 INTERVENTION. 316 00:15:09,445 --> 00:15:11,514 FOR SOCIETAL CONCERN ONE COULD 317 00:15:11,514 --> 00:15:18,755 BE THE EFFECTS OF SOCIAL GROUP 318 00:15:18,755 --> 00:15:19,789 CHARACTERISTIC. 319 00:15:19,789 --> 00:15:22,392 THE NEPAL STUDY AND CAN FOCUS ON 320 00:15:22,392 --> 00:15:24,928 THE TRADITIONALLY EXCLUDED GROUP 321 00:15:24,928 --> 00:15:31,301 THE INTERVENTION STUDY. 322 00:15:31,301 --> 00:15:33,403 PRIMARY INTEREST HERE IS WHY 323 00:15:33,403 --> 00:15:35,705 WE'RE INTERESTED IN SOCIETAL 324 00:15:35,705 --> 00:15:37,307 CONCERN IS IT'S DRIVEN FOR THE 325 00:15:37,307 --> 00:15:40,944 CONCERN FOR UNFAIRNESS OR 326 00:15:40,944 --> 00:15:42,045 INEQUITY. 327 00:15:42,045 --> 00:15:45,648 SO WHEN WE THINK ABOUT THEM 328 00:15:45,648 --> 00:15:46,683 THERE'S SOMETHING WRONG ABOUT 329 00:15:46,683 --> 00:15:47,617 THEM ETHICALLY AND MORALLY 330 00:15:47,617 --> 00:15:51,621 SHOULD BE THE REASON WHY WE WANT 331 00:15:51,621 --> 00:15:53,222 TO STUDY. 332 00:15:53,222 --> 00:15:56,926 SO HERE'S A GOOD TIME TO TALK 333 00:15:56,926 --> 00:16:00,129 ABOUT TERMINOLOGY. 334 00:16:00,129 --> 00:16:02,398 I'VE BEEN SAYING EQUITY, 335 00:16:02,398 --> 00:16:03,066 INEQUALITY AND DIFFERENT TERMS 336 00:16:03,066 --> 00:16:06,402 AND IT'S SUPER CONFUSING BECAUSE 337 00:16:06,402 --> 00:16:09,672 THERE'S MANY SIMILAR TERMS AND 338 00:16:09,672 --> 00:16:10,807 UNFORTUNATELY RESEARCHERS DON'T 339 00:16:10,807 --> 00:16:12,942 USE CONSISTENTLY AND ALSO WHEN 340 00:16:12,942 --> 00:16:17,146 YOU TALK TO PHILOSOPHERS, PUBLIC 341 00:16:17,146 --> 00:16:19,682 HEALTH PEOPLE, IT'S DIFFERENT. 342 00:16:19,682 --> 00:16:21,417 I WOULD CLAIM THIS IS THE WAY 343 00:16:21,417 --> 00:16:22,852 PEOPLE SHOULD USE BUT THIS IS 344 00:16:22,852 --> 00:16:25,054 HOW I MAKE SENSE OF IT. 345 00:16:25,054 --> 00:16:25,955 AND I HOPE IT MAKES SENSE TO 346 00:16:25,955 --> 00:16:28,791 YOU. 347 00:16:28,791 --> 00:16:31,060 AND MY ADVICE IS TO UNDERSTAND 348 00:16:31,060 --> 00:16:32,929 THIS NOW AND WHEN YOU TALK TO 349 00:16:32,929 --> 00:16:34,998 PEOPLE ABOUT EQUITY, YOU SHOULD 350 00:16:34,998 --> 00:16:38,735 HAVE A CONVERSATION WHAT DO YOU 351 00:16:38,735 --> 00:16:39,769 MEAN, EQUITY AND MAKE IT CLEAR 352 00:16:39,769 --> 00:16:41,671 WHAT YOU'RE TALKING ABOUT. 353 00:16:41,671 --> 00:16:43,473 IT'S SUPER CONFUSING IN THE 354 00:16:43,473 --> 00:16:43,673 FIELD. 355 00:16:43,673 --> 00:16:45,341 I'VE BEEN WORKING IN THIS FIELD 356 00:16:45,341 --> 00:16:46,776 FOR 20 YEARS AND IT'S 357 00:16:46,776 --> 00:16:48,745 UNFORTUNATELY STILL LIKE THAT. 358 00:16:48,745 --> 00:16:51,981 SO THE WAY IT MAKES SENSE TO ME 359 00:16:51,981 --> 00:16:55,518 IS THE HEALTH INEQUALITIES. 360 00:16:55,518 --> 00:17:00,923 THESE ARE HEALTH DIFFERENCES 361 00:17:00,923 --> 00:17:11,401 BETWEEN GROUPS OR INDIVIDUALS. 362 00:17:11,401 --> 00:17:14,337 THEN AMONG THEM HEALTH 363 00:17:14,337 --> 00:17:14,637 INEQUITIES. 364 00:17:14,637 --> 00:17:17,473 AND WHEN I SAY HEALTH 365 00:17:17,473 --> 00:17:19,942 DIFFERENCES ACROSS GROUPS OR 366 00:17:19,942 --> 00:17:21,944 INDIVIDUALS. 367 00:17:21,944 --> 00:17:24,047 AND YOU CAN IMAGINE FAIR YOU CAN 368 00:17:24,047 --> 00:17:26,582 DEFINE DIFFERENTLY AND MAYBE 369 00:17:26,582 --> 00:17:29,452 DEPENDS ON HOW YOU FEEL BUT THE 370 00:17:29,452 --> 00:17:31,387 DIFFERENCE IS HOUSING 371 00:17:31,387 --> 00:17:33,756 INEQUALITIES ARE NOT ETHICAL OR 372 00:17:33,756 --> 00:17:35,525 MORAL IT'S A DIFFERENT CATEGORY 373 00:17:35,525 --> 00:17:36,793 OF DIFFERENCES AND WHEN YOU 374 00:17:36,793 --> 00:17:41,731 START TO THINK ABOUT FAIRNESS, 375 00:17:41,731 --> 00:17:44,333 ETHICALLY, PROBLEMATIC, THEN 376 00:17:44,333 --> 00:17:47,737 IT'S INEQUITY. 377 00:17:47,737 --> 00:17:50,740 AND THAT OFTEN YOU HAVE 378 00:17:50,740 --> 00:17:53,242 DISPARITIES AND THE TERM USED A 379 00:17:53,242 --> 00:17:54,077 LOT IN THE UNITED STATES AND 380 00:17:54,077 --> 00:17:55,578 THIS IS HOW I UNDERSTAND IT. 381 00:17:55,578 --> 00:17:56,946 IT'S ONE WAY TO TODAY FINE WHAT 382 00:17:56,946 --> 00:18:01,384 IS UNFAIR. 383 00:18:01,384 --> 00:18:06,622 -- TO DEFINE WHAT IS UNFAIR AND 384 00:18:06,622 --> 00:18:09,859 MEANINGFUL CHARACTERISTICS OFTEN 385 00:18:09,859 --> 00:18:10,927 INDICATIVE OF SOCIAL 386 00:18:10,927 --> 00:18:11,260 DISADVANTAGE. 387 00:18:11,260 --> 00:18:13,963 FOR EXAMPLE, HEALTH DISPARITIES 388 00:18:13,963 --> 00:18:19,135 OR HEALTH DIFFERENCES BY RACE, 389 00:18:19,135 --> 00:18:20,136 INCOME, EDUCATION, DISABILITY 390 00:18:20,136 --> 00:18:24,740 STATUS AND THOSE GROUPS KIND OF 391 00:18:24,740 --> 00:18:28,144 INDICATE SOCIAL DISADVANTAGE. 392 00:18:28,144 --> 00:18:30,346 AND THEN HEALTH EQUITY WHICH I 393 00:18:30,346 --> 00:18:32,915 USE AS THE ABSENCE OF HEALTH 394 00:18:32,915 --> 00:18:33,249 INEQUITIES. 395 00:18:33,249 --> 00:18:34,550 IF YOU FORGET EVERYTHING ABOUT 396 00:18:34,550 --> 00:18:40,389 WHAT I SAY TODAY, I HOPE THIS IS 397 00:18:40,389 --> 00:18:42,058 THE ONE THAT SHOWS UP IN YOUR 398 00:18:42,058 --> 00:18:43,626 DREAM SOME TIME. 399 00:18:43,626 --> 00:18:46,562 SO I'LL STOP HERE WITH THIS 400 00:18:46,562 --> 00:18:47,363 DEFINITION BECAUSE I THINK IT'S 401 00:18:47,363 --> 00:18:48,631 ONE OF THE KEY POINTS TODAY. 402 00:18:48,631 --> 00:18:54,937 DO YOU HAVE ANY QUESTIONS HERE? 403 00:18:54,937 --> 00:18:55,938 DID I CONVINCE YOU AND IT'S 404 00:18:55,938 --> 00:19:06,115 CLEAR NOW? 405 00:19:08,851 --> 00:19:10,953 >> SO, WE TALKED ABOUT THIS BUT 406 00:19:10,953 --> 00:19:13,756 I WANTED TO RAISE THE FACT THAT 407 00:19:13,756 --> 00:19:16,159 HEALTH INEQUITIES THAT'S OFTEN 408 00:19:16,159 --> 00:19:18,427 THE TERM USED IN 409 00:19:18,427 --> 00:19:20,496 NON-U.S. CONTEXT AND DISPARITIES 410 00:19:20,496 --> 00:19:24,467 USED IN THE U.S. CONTEXT. 411 00:19:24,467 --> 00:19:26,969 DO DIFFERENCE IN THE DEFINITIONS 412 00:19:26,969 --> 00:19:29,572 REFLECT HOW THE U.S. SEES HEALTH 413 00:19:29,572 --> 00:19:30,239 DISPARITIES COMPARED TO THE REST 414 00:19:30,239 --> 00:19:32,909 OF THE WORLD? 415 00:19:32,909 --> 00:19:40,683 >> THIS IS CONSISTENT WITH THE 416 00:19:40,683 --> 00:19:45,688 TERMS USED IN THE UNITED STATES. 417 00:19:45,688 --> 00:19:47,790 THE PAST DECADES PEOPLE STARTED 418 00:19:47,790 --> 00:19:49,792 TO USE IN THE UNITED STATES 419 00:19:49,792 --> 00:19:54,297 INEQUITIES ARE USED AND THEN SO 420 00:19:54,297 --> 00:19:59,001 ETHICAL PART IS MORE EXPLICIT. 421 00:19:59,001 --> 00:20:01,837 I THINK PEOPLE, SCIENTISTS, 422 00:20:01,837 --> 00:20:02,505 PUBLIC HEALTH RESEARCHERS FELT 423 00:20:02,505 --> 00:20:07,777 WHEN YOU START TO SAY INEQUITY 424 00:20:07,777 --> 00:20:09,645 IT STANDS FOR SCIENCE BECAUSE 425 00:20:09,645 --> 00:20:11,480 YOU'RE TALKING ABOUT MORALITY 426 00:20:11,480 --> 00:20:13,516 AND ETHICS. 427 00:20:13,516 --> 00:20:14,317 THAT'S NOT SCIENCE. 428 00:20:14,317 --> 00:20:16,886 SOW PEOPLE FELT IT'S LIKE, WELL, 429 00:20:16,886 --> 00:20:18,154 I'M A SCIENTIST. 430 00:20:18,154 --> 00:20:23,559 I WANT TO TALK ABOUT NUMBERS AND 431 00:20:23,559 --> 00:20:28,364 SO MAYBE DISPARITIES SOUNDS 432 00:20:28,364 --> 00:20:28,664 BETTER. 433 00:20:28,664 --> 00:20:31,934 BECAUSE IT'S A BIT AMBIGUOUS. 434 00:20:31,934 --> 00:20:34,837 THAT'S HOW IT STARTED AND THE 435 00:20:34,837 --> 00:20:35,938 DISPARITIES WERE TOSSED AROUND 436 00:20:35,938 --> 00:20:37,506 BETWEEN INEQUALITY AND INEQUITY 437 00:20:37,506 --> 00:20:40,443 FOR A LONG TIME AND NOW I THINK 438 00:20:40,443 --> 00:20:43,045 PEOPLE ARE MORE COMFORTABLE TO 439 00:20:43,045 --> 00:20:46,616 SAY WHEN WE SAY HEALTH 440 00:20:46,616 --> 00:20:47,617 DISPARITIES, IT'S SOCIAL 441 00:20:47,617 --> 00:20:47,950 DISADVANTAGE. 442 00:20:47,950 --> 00:20:52,188 SO ETHICS IS FRONT AND CENTER. 443 00:20:52,188 --> 00:20:53,556 SO IT'S AN INTERESTING HISTORY. 444 00:20:53,556 --> 00:20:53,923 >> THANKS. 445 00:20:53,923 --> 00:20:59,161 >> THANK YOU. 446 00:20:59,161 --> 00:20:59,362 OKAY. 447 00:20:59,362 --> 00:21:00,096 CAN I MOVE ON. 448 00:21:00,096 --> 00:21:04,100 >> NO QUESTIONS FROM VIDEO LAND. 449 00:21:04,100 --> 00:21:05,768 >> I WILL FEEL GOOD IF THIS IS 450 00:21:05,768 --> 00:21:07,303 CLEAR SO LET'S MOVE ON. 451 00:21:07,303 --> 00:21:11,374 SO I KIND OF MADE A BIG THING 452 00:21:11,374 --> 00:21:13,709 ABOUT THE SOCIETAL CONCERN AND 453 00:21:13,709 --> 00:21:15,211 TALK ABOUT INEQUITY, 454 00:21:15,211 --> 00:21:17,179 DISPARITIES, DIFFERENCE AND SO I 455 00:21:17,179 --> 00:21:21,484 CARRY ON THAT. 456 00:21:21,484 --> 00:21:27,723 AND NOW IT COMES TO WHICH 457 00:21:27,723 --> 00:21:33,629 HOUSING EQUALITIES IS FAIR AND 458 00:21:33,629 --> 00:21:36,065 WHY AND INEQUITY IS FAIR AND 459 00:21:36,065 --> 00:21:39,568 EQUALITY IS WHAT DO YOU MEAN BY 460 00:21:39,568 --> 00:21:42,171 FAIR. 461 00:21:42,171 --> 00:21:45,775 JUST STEPPING BACK, INCLUDING 462 00:21:45,775 --> 00:21:47,710 DIVERSE STUDY SUBJECTS FOR 463 00:21:47,710 --> 00:21:48,144 SOCIETAL CONCERN. 464 00:21:48,144 --> 00:21:51,013 THAT KIND OF STUDY IS OFTEN 465 00:21:51,013 --> 00:21:53,082 OPERATIONALIZED TO FOCUS ON 466 00:21:53,082 --> 00:21:53,716 HISTORICALLY OVERLOOKED SOCIAL 467 00:21:53,716 --> 00:21:57,186 GROUPS. 468 00:21:57,186 --> 00:22:01,824 SO, AS I ALREADY MENTIONED IN 469 00:22:01,824 --> 00:22:04,193 THE HEALTH DISPARITY GROUPS 470 00:22:04,193 --> 00:22:05,861 LOOKING AT SOCIAL DISADVANTAGE 471 00:22:05,861 --> 00:22:06,996 OR POWER IMBALANCE. 472 00:22:06,996 --> 00:22:09,598 SO WHAT ARE THE GROUPS? 473 00:22:09,598 --> 00:22:12,935 I ALREADY HINTED. 474 00:22:12,935 --> 00:22:16,806 NIH GUIDELINES SAYS THE MINORITY 475 00:22:16,806 --> 00:22:19,141 GROUP IS READILY IDENTIFIABLE 476 00:22:19,141 --> 00:22:21,577 SUBSET OF THE U.S. POPULATION 477 00:22:21,577 --> 00:22:23,245 WHICH IS DISTINGUISHED BY EITHER 478 00:22:23,245 --> 00:22:26,382 RACIAL, ETHNIC AND/OR CULTURAL 479 00:22:26,382 --> 00:22:26,782 HERITAGE. 480 00:22:26,782 --> 00:22:28,918 SO THAT'S THEIR DEFINITION. 481 00:22:28,918 --> 00:22:31,554 AND ALSO THERE'S THIS THING 482 00:22:31,554 --> 00:22:32,922 CALLED PROGRESS PLUS. 483 00:22:32,922 --> 00:22:34,957 THIS IS JUST ACRONYM SO YOU CAN 484 00:22:34,957 --> 00:22:39,061 SEE WHAT THE PROGRESS STANDS FOR 485 00:22:39,061 --> 00:22:39,328 HERE. 486 00:22:39,328 --> 00:22:45,134 SO THIS IS DEVELOPED BY SOME 487 00:22:45,134 --> 00:22:52,908 RESEARCHERS, 2003 AND A SYSTEM 488 00:22:52,908 --> 00:22:56,512 FOR THE SYSTEMATIC REVIEW AND 489 00:22:56,512 --> 00:22:56,779 ANALYSIS. 490 00:22:56,779 --> 00:22:57,713 THERE'S MANY VERY DIFFERENT 491 00:22:57,713 --> 00:23:00,916 SINGLE STUDIES BUT WE NEED TO 492 00:23:00,916 --> 00:23:02,618 LOOK AT THE EVIDENCE TOGETHER 493 00:23:02,618 --> 00:23:04,086 AND WHAT WE CAN SAY AND HOW TO 494 00:23:04,086 --> 00:23:04,920 DO IT. 495 00:23:04,920 --> 00:23:08,424 THAT'S THE KIND OF GROUPS AND 496 00:23:08,424 --> 00:23:12,628 THEN THEY TOOK ON TO MAYBE 497 00:23:12,628 --> 00:23:13,963 EQUITY CONSIDERATIONS ARE 498 00:23:13,963 --> 00:23:15,164 IMPORTANT AND PROMOTE THE 499 00:23:15,164 --> 00:23:16,165 PROGRESS PLUS. 500 00:23:16,165 --> 00:23:18,868 IF WE'RE INTERESTED IN CERTAIN 501 00:23:18,868 --> 00:23:19,935 GROUPS FOR SOCIETAL CONCERN, 502 00:23:19,935 --> 00:23:21,804 THESE ARE THE GROUPS TO LOOK AT 503 00:23:21,804 --> 00:23:22,004 THEN. 504 00:23:22,004 --> 00:23:24,039 AND HERE, WHATEVER WAY YOU LOOK 505 00:23:24,039 --> 00:23:28,310 AT IN THE LITERATURE, THE COMMON 506 00:23:28,310 --> 00:23:30,179 THREAD IS WHAT I CALL BIVARIATE 507 00:23:30,179 --> 00:23:30,446 APPROACH. 508 00:23:30,446 --> 00:23:33,182 THIS IS HOW WE THINK. 509 00:23:33,182 --> 00:23:35,217 THERE'S LEATH WHATEVER, HEALTH 510 00:23:35,217 --> 00:23:36,752 OUTCOME YOU LOOK UP. 511 00:23:36,752 --> 00:23:43,125 IT COULD BE LIFE EXPECTANCY, 512 00:23:43,125 --> 00:23:43,959 MORTALITY, RP QUALITY OF LIFE, 513 00:23:43,959 --> 00:23:45,728 CANCER PREVALENCE, WHATEVER, YOU 514 00:23:45,728 --> 00:23:47,163 CAN TAKE A LOOK. 515 00:23:47,163 --> 00:23:48,063 IT'S HEALTH YOU CAN MEASURE AND 516 00:23:48,063 --> 00:23:51,167 GOING UP IS HEALTHY AND DOWN IS 517 00:23:51,167 --> 00:23:52,735 LESS HEALTHY AND THEN YOU HAVE 518 00:23:52,735 --> 00:23:55,938 THE SOCIAL GROUPS YOU'RE 519 00:23:55,938 --> 00:23:58,707 INTERESTED IN AND I CALL 520 00:23:58,707 --> 00:24:04,580 ATTRIBUTE BY INCOME, RACE, 521 00:24:04,580 --> 00:24:06,982 ETHNICITY, SEXUAL AND DIFFERENT 522 00:24:06,982 --> 00:24:07,349 GROUPS. 523 00:24:07,349 --> 00:24:08,951 THIS IS HOW PEOPLE TYPICALLY 524 00:24:08,951 --> 00:24:13,956 THINK ABOUT IT. 525 00:24:13,956 --> 00:24:20,329 IT'S OKAY BUT I THINK THERE'S 526 00:24:20,329 --> 00:24:22,231 CHALLENGES IN THIS WAY OF 527 00:24:22,231 --> 00:24:22,498 THINKING. 528 00:24:22,498 --> 00:24:27,203 THESE ARE GROUPS THAT INDICATE 529 00:24:27,203 --> 00:24:27,770 SOCIAL DISADVANTAGE. 530 00:24:27,770 --> 00:24:30,306 IT'S GROWING LONGER AND LONGER 531 00:24:30,306 --> 00:24:31,440 EVERY YEAR. 532 00:24:31,440 --> 00:24:34,610 WHICH IN ITSELF IS NOT A BAD 533 00:24:34,610 --> 00:24:37,079 THING AND WE ARE MORE SENSITIVE 534 00:24:37,079 --> 00:24:39,482 ABOUT THE ISSUES BUT IT'S 535 00:24:39,482 --> 00:24:41,717 GETTING LONGER MEANING THERE'S 536 00:24:41,717 --> 00:24:46,856 MANY GROUPS EVERY YEAR. 537 00:24:46,856 --> 00:24:54,129 AND ALSO IN THAT PICTURE LOOKS 538 00:24:54,129 --> 00:24:56,532 LIKE IF YOU'RE IN THIS GROUP 539 00:24:56,532 --> 00:24:58,701 YOU'RE HEALTHIER AND IT'S NOT 540 00:24:58,701 --> 00:25:00,769 ALWAYS TRUE AND IN THE OBESITY 541 00:25:00,769 --> 00:25:04,173 STUDY YOU WENT TO THE LOWER 542 00:25:04,173 --> 00:25:05,007 INCOME NEIGHBORHOOD BUT THERE'S 543 00:25:05,007 --> 00:25:06,108 RACIAL DIFFERENCES. 544 00:25:06,108 --> 00:25:08,911 SO THERE'S SOME DIFFERENCES 545 00:25:08,911 --> 00:25:09,478 BETWEEN THEM. 546 00:25:09,478 --> 00:25:12,948 BUT THIS WAY OF LOOKING AT IS 547 00:25:12,948 --> 00:25:14,783 THE INTERSECTIONALITY ARE OFTEN 548 00:25:14,783 --> 00:25:15,084 OVERLOOKED. 549 00:25:15,084 --> 00:25:17,486 AND IF YOU START TO PAY 550 00:25:17,486 --> 00:25:20,055 ATTENTION TO INTERSECTIONALITY, 551 00:25:20,055 --> 00:25:21,891 FOR EXAMPLE, THE INCOME THEN YOU 552 00:25:21,891 --> 00:25:25,027 HAVE MORE NUMBER OF PEOPLE TO 553 00:25:25,027 --> 00:25:25,961 LOOK INTO. 554 00:25:25,961 --> 00:25:28,797 THE GROUP IS GETTING MORE AND 555 00:25:28,797 --> 00:25:30,699 MORE AND INTERESTINGLY THE GROUP 556 00:25:30,699 --> 00:25:35,170 DEFINITION ITSELF COULD CHANGE. 557 00:25:35,170 --> 00:25:36,805 WE CAN THINK ABOUT SEX. 558 00:25:36,805 --> 00:25:39,408 WHEN I WENT TO GRADUATE SCHOOL, 559 00:25:39,408 --> 00:25:42,077 YEAH, SEX IS A BINARY VARIABLE 560 00:25:42,077 --> 00:25:43,779 AND MAYBE NOT, IT'S CONTINUOUS. 561 00:25:43,779 --> 00:25:47,416 YOU HAVE TO MEASURE DIFFERENTLY. 562 00:25:47,416 --> 00:25:49,251 SO, THAT GROUP DEFINITION ITSELF 563 00:25:49,251 --> 00:25:51,787 COULD CHANGE AND THEN OFTEN 564 00:25:51,787 --> 00:25:53,923 THOSE REASONS WHY THE SELECTED 565 00:25:53,923 --> 00:25:57,326 GROUP CHARACTERISTICS SIGNIFIES 566 00:25:57,326 --> 00:26:00,930 CONCERNS FOR FAIRNESS AND 567 00:26:00,930 --> 00:26:04,833 INEQUITY ARE OFTEN JUST A SOCIAL 568 00:26:04,833 --> 00:26:06,502 DISADVANTAGE AND YOU DON'T GO 569 00:26:06,502 --> 00:26:07,937 ANYTHING BEYOND. 570 00:26:07,937 --> 00:26:09,371 SO THEN WHAT'S HAPPENING IS 571 00:26:09,371 --> 00:26:10,906 THERE'S SO MANY DIFFERENT GROUPS 572 00:26:10,906 --> 00:26:13,108 WE THINK IT'S IMPORTANT AND THEN 573 00:26:13,108 --> 00:26:15,711 WE DESCRIBE INEQUALITY. 574 00:26:15,711 --> 00:26:18,814 THIS WAY AND MULTIPLE WAYS AND 575 00:26:18,814 --> 00:26:19,949 LOTS OF INFORMATION. 576 00:26:19,949 --> 00:26:21,417 THEN A SIMPLE QUESTION LIKE ARE 577 00:26:21,417 --> 00:26:23,452 WITH MAKING ANY PROGRESS TO 578 00:26:23,452 --> 00:26:25,454 REDUCE THOSE INEQUALITIES? 579 00:26:25,454 --> 00:26:26,889 WE DON'T KNOW BECAUSE THERE'S SO 580 00:26:26,889 --> 00:26:33,896 MANY AND HOW CAN WE SYNTHESIZE 581 00:26:33,896 --> 00:26:35,764 THE RESULTS? 582 00:26:35,764 --> 00:26:40,402 WE DON'T KNOW. 583 00:26:40,402 --> 00:26:42,938 SO I THINK A DEEPER DISCUSSION 584 00:26:42,938 --> 00:26:45,207 IS NEEDED TO INCLUDE THE DIVERSE 585 00:26:45,207 --> 00:26:47,810 SUBJECT FOR SOCIETAL CONCERN. 586 00:26:47,810 --> 00:26:50,512 AS I MENTIONED EXAMPLES OF THE 587 00:26:50,512 --> 00:26:52,648 SOCIAL GROUPS OF CONCERN, RACIAL 588 00:26:52,648 --> 00:26:56,051 ETHNIC MINORITIES, SEXUAL GENDER 589 00:26:56,051 --> 00:26:57,820 MINORITIES, PEOPLE WITH LOW 590 00:26:57,820 --> 00:26:59,521 INCOME AND DISABILITIES ARE 591 00:26:59,521 --> 00:27:00,289 EXAMPLES. 592 00:27:00,289 --> 00:27:03,626 THEN YOU HAVE TO ASK WHICH 593 00:27:03,626 --> 00:27:08,931 GROUPS TO CHOOSE AND RIGHT NOW 594 00:27:08,931 --> 00:27:12,434 RESEARCHERS JUST PICK BUT MAYBE 595 00:27:12,434 --> 00:27:16,805 WE CAN DO DEEPER AND PHILOSOPHY 596 00:27:16,805 --> 00:27:19,942 AND WHY ONE IS CONCERNED ABOUT 597 00:27:19,942 --> 00:27:23,579 THE SOCIAL GROUPS. 598 00:27:23,579 --> 00:27:27,349 SO HERE ONE EXAMPLE OF THE WORK. 599 00:27:27,349 --> 00:27:29,018 MAYBE YOU'RE CONCERNED ABOUT 600 00:27:29,018 --> 00:27:30,552 RECOGNITION OF PEOPLE. 601 00:27:30,552 --> 00:27:33,689 THEN IT'S A GOOD REASON TO PICK 602 00:27:33,689 --> 00:27:36,058 RACIAL, ETHNIC OR SEXUAL GENDER 603 00:27:36,058 --> 00:27:36,325 MINORITY. 604 00:27:36,325 --> 00:27:39,428 SOMETHING TO DO WITH 605 00:27:39,428 --> 00:27:39,795 DISCRIMINATION. 606 00:27:39,795 --> 00:27:40,696 YOU MIGHT PICK THOSE. 607 00:27:40,696 --> 00:27:42,931 OR MAYBE YOU'RE CONCERNED ABOUT 608 00:27:42,931 --> 00:27:43,198 RESOURCES. 609 00:27:43,198 --> 00:27:46,435 HOW RESOURCES ARE DISTRIBUTED. 610 00:27:46,435 --> 00:27:51,674 SO YOU MIGHT GO TO A GROUP LIKE 611 00:27:51,674 --> 00:27:54,510 PEOPLE WITH LOW INCOME 612 00:27:54,510 --> 00:27:56,912 MEDICATION OR MAYBE A POLITICAL 613 00:27:56,912 --> 00:27:57,279 REPRESENTATION. 614 00:27:57,279 --> 00:27:59,648 THAT'S YOUR REASON THEN PEOPLE 615 00:27:59,648 --> 00:28:02,418 WITH DISABILITY. 616 00:28:02,418 --> 00:28:04,186 THEY'RE EXAMPLES BUT YOU CAN GO 617 00:28:04,186 --> 00:28:05,754 DEEPER AND THAT MAY GIVE YOU 618 00:28:05,754 --> 00:28:11,260 SOME REASON WHY YOU PICK THOSE 619 00:28:11,260 --> 00:28:11,493 GROUPS. 620 00:28:11,493 --> 00:28:13,529 OR I ADD THE RESTORATION. 621 00:28:13,529 --> 00:28:16,098 I'M FROM CANADA SO I FEEL MORE 622 00:28:16,098 --> 00:28:18,767 COMFORTABLE TO GIVE YOU AN 623 00:28:18,767 --> 00:28:20,936 EXAMPLE HERE, CANADIAN EXAMPLE 624 00:28:20,936 --> 00:28:22,805 WHICH IS INDIGENOUS POPULATION. 625 00:28:22,805 --> 00:28:25,941 IN CANADA THE PAST 10 YEARS 626 00:28:25,941 --> 00:28:27,309 INDIGENOUS POPULATIONS AND WHAT 627 00:28:27,309 --> 00:28:31,613 CANADA DID TO THEM BECAME SO 628 00:28:31,613 --> 00:28:34,383 IMPORTANT AND NOW IT'S LIKE 629 00:28:34,383 --> 00:28:36,085 THEIR RICH INDIGENOUS PEOPLE, 630 00:28:36,085 --> 00:28:40,222 HIGHLY EDUCATED, POLITICALLY 631 00:28:40,222 --> 00:28:40,889 STRONGLY INFLUENTIAL INDIGENOUS 632 00:28:40,889 --> 00:28:42,624 PEOPLE BUT IT DOESN'T MATTER. 633 00:28:42,624 --> 00:28:43,959 IF YOU HAVE INDIGENOUS HERITAGE, 634 00:28:43,959 --> 00:28:46,895 WE HAVE TO BE WORRIED BECAUSE OF 635 00:28:46,895 --> 00:28:47,996 THE HISTORICAL REASON OF WHAT WE 636 00:28:47,996 --> 00:28:57,539 DID AS A COUNTRY. 637 00:28:57,539 --> 00:28:58,907 THAT COULD BE ONE GOOD REASON. 638 00:28:58,907 --> 00:29:00,809 I WANT TO HAVE THAT CONVERSATION 639 00:29:00,809 --> 00:29:03,378 GOING A LITTLE BIT FOR THE 640 00:29:03,378 --> 00:29:04,546 EMPIRICAL RESEARCHERS TO SHOW 641 00:29:04,546 --> 00:29:07,116 THESE KINDS OF RESULTS. 642 00:29:07,116 --> 00:29:08,784 THAT'S MY HOPE AND PEOPLE START 643 00:29:08,784 --> 00:29:12,054 TO TALK ABOUT IT MORE. 644 00:29:12,054 --> 00:29:13,322 SO THE FINAL QUESTION. 645 00:29:13,322 --> 00:29:17,526 NOW I HOPE YOU KIND OF HAVE 646 00:29:17,526 --> 00:29:19,394 IDEAS OF WHAT THIS EQUITY 647 00:29:19,394 --> 00:29:21,530 CONSIDERATIONS ARE. 648 00:29:21,530 --> 00:29:23,866 BUT THEN HOW DO EQUITY 649 00:29:23,866 --> 00:29:24,466 CONSIDERATIONS INFLUENCE THE 650 00:29:24,466 --> 00:29:25,000 STUDY DESIGN ANALYSIS AND 651 00:29:25,000 --> 00:29:34,610 REPORTING? 652 00:29:34,610 --> 00:29:37,546 WHY YOU WANT TO LOOK AT SOCIETAL 653 00:29:37,546 --> 00:29:38,380 CONCERNS AND BIOLOGY. 654 00:29:38,380 --> 00:29:40,449 I WANT TO WALK YOU THROUGH IT 655 00:29:40,449 --> 00:29:42,684 BUT HERE'S STEPPING BACK THE 656 00:29:42,684 --> 00:29:44,787 TRADITIONAL STUDY IS YOU HAVE A 657 00:29:44,787 --> 00:29:47,156 POPULATION AND YOU PICK THE 658 00:29:47,156 --> 00:29:48,557 STUDY SUBJECT INTERVENTION GROUP 659 00:29:48,557 --> 00:29:49,224 TO KNOWN INTERVENTION GROUP AND 660 00:29:49,224 --> 00:29:52,461 YOU WANT TO SEE THE OUTCOME AND 661 00:29:52,461 --> 00:29:53,362 HOW IT'S DIFFERENT. 662 00:29:53,362 --> 00:29:56,799 THIS IS THE TYPICAL WAY TO DO 663 00:29:56,799 --> 00:29:58,267 IT. 664 00:29:58,267 --> 00:30:00,302 THE EXAMPLE, HYPOTHETICAL 665 00:30:00,302 --> 00:30:01,970 EXAMPLE I ASSIGNED IN THE WORK 666 00:30:01,970 --> 00:30:06,008 SO I WANT TO WALK YOU THROUGH 667 00:30:06,008 --> 00:30:07,743 THE EXAMPLE. 668 00:30:07,743 --> 00:30:10,078 POPULATIONS OF LOW INCOME 669 00:30:10,078 --> 00:30:11,513 COUNTRY. 670 00:30:11,513 --> 00:30:13,682 INTERVENTION IS AN DIETARY 671 00:30:13,682 --> 00:30:15,584 INDICATION AND SUPPLEMENTATION 672 00:30:15,584 --> 00:30:20,923 PROGRAM MUCH LIKE PREGNANT 673 00:30:20,923 --> 00:30:24,927 WOMEN. 674 00:30:24,927 --> 00:30:31,934 THE INTERVENTION STUDY AND IT'S 675 00:30:31,934 --> 00:30:33,902 BABIES WHOSE MOTHERS DID NOT 676 00:30:33,902 --> 00:30:34,970 RECEIVE THE INTERVENTION. 677 00:30:34,970 --> 00:30:36,438 SO TRADITIONAL STUDY IS 678 00:30:36,438 --> 00:30:38,373 UNUSUALLY WE LOOK AT THE AVERAGE 679 00:30:38,373 --> 00:30:40,142 TREATMENT EFFECT. 680 00:30:40,142 --> 00:30:46,915 SO HERE YOU SEE THE DENSITY LIKE 681 00:30:46,915 --> 00:30:48,784 THE BIRTH WEIGHT AND HERE'S THE 682 00:30:48,784 --> 00:30:52,821 BIRTH WEIGHT GOING THAT WAY. 683 00:30:52,821 --> 00:30:56,225 THEN IT'S THE DISTRIBUTION OF IT 684 00:30:56,225 --> 00:30:57,626 AND CONTROL AND TREATED IS A 685 00:30:57,626 --> 00:31:04,499 DIFFERENT COLOR. 686 00:31:04,499 --> 00:31:06,602 ON THE DOTTED LINE IS THE 687 00:31:06,602 --> 00:31:06,869 AVERAGE. 688 00:31:06,869 --> 00:31:10,505 SO YOU ANALYZE THE DIFFERENCE 689 00:31:10,505 --> 00:31:14,643 BETWEEN THE MEANS AND YOU REPORT 690 00:31:14,643 --> 00:31:16,912 WHAT'S THE DIFFERENCE BETWEEN 691 00:31:16,912 --> 00:31:17,112 THEM. 692 00:31:17,112 --> 00:31:18,447 THAT'S THE TRADITIONAL WAY THE 693 00:31:18,447 --> 00:31:20,115 TYPICAL INTERVENTION STUDIES WE 694 00:31:20,115 --> 00:31:20,482 DO. 695 00:31:20,482 --> 00:31:23,518 SO HOW DOES IT LOOK IF YOU HAVE 696 00:31:23,518 --> 00:31:26,388 EQUITY CONSIDERATIONS? 697 00:31:26,388 --> 00:31:27,956 SO THE REASON WHY YOU'RE 698 00:31:27,956 --> 00:31:30,459 INTERESTED IN INCLUDING DIVERSE 699 00:31:30,459 --> 00:31:31,827 POPULATION IS THE PARTICIPATION. 700 00:31:31,827 --> 00:31:37,833 WE ALREADY TALKED ABOUT THIS, 701 00:31:37,833 --> 00:31:39,234 RIGHT? 702 00:31:39,234 --> 00:31:40,068 AND THEN FAIR SUBJECT SELECTION 703 00:31:40,068 --> 00:31:42,738 IS A PRIMARY CONCERN AND IF 704 00:31:42,738 --> 00:31:44,740 THERE'S NO REASON TO SUSPECT OR 705 00:31:44,740 --> 00:31:46,642 BE INTERESTED IN POTENTIALLY 706 00:31:46,642 --> 00:31:48,010 DIFFERENTIAL INTERVENTION 707 00:31:48,010 --> 00:31:51,246 EFFECTS DUE TO BIOLOGY OR 708 00:31:51,246 --> 00:31:54,750 SOCIETAL CONCERNS, NO ADDITIONAL 709 00:31:54,750 --> 00:31:55,350 CONSIDERATIONS FOR THE STUDY 710 00:31:55,350 --> 00:31:56,685 DESIGN AND REPORTING MAY BE 711 00:31:56,685 --> 00:31:56,952 NECESSARY. 712 00:31:56,952 --> 00:31:59,054 ALL YOU HAVE TO WORRY ABOUT IS 713 00:31:59,054 --> 00:32:01,957 YOU GO TO THE DIVERSE POPULATION 714 00:32:01,957 --> 00:32:04,626 AND YOU MAKE SURE THAT THE STUDY 715 00:32:04,626 --> 00:32:08,430 SUBJECT SELECTION IS FAIR. 716 00:32:08,430 --> 00:32:11,566 AND YOU DO BUSINESS AS USUAL. 717 00:32:11,566 --> 00:32:14,136 BUT IF IT'S BIOLOGY, REMEMBER 718 00:32:14,136 --> 00:32:15,103 WITHIN AN CARDIOVASCULAR DISEASE 719 00:32:15,103 --> 00:32:16,538 MEN AND WOMEN ARE DIFFERENT. 720 00:32:16,538 --> 00:32:21,710 THEN IT HAS A BIG IMPLICATION 721 00:32:21,710 --> 00:32:23,412 FOR STUDY DESIGN AND REPORTING. 722 00:32:23,412 --> 00:32:25,213 YOU NEED TO MAKE SURE YOU 723 00:32:25,213 --> 00:32:27,082 INCLUDE BOTH GROUPS MEN AND 724 00:32:27,082 --> 00:32:28,417 WOMEN IN THAT EXAMPLE. 725 00:32:28,417 --> 00:32:32,454 YOU HAVE TO RUN THE STUDY AMONG 726 00:32:32,454 --> 00:32:34,990 THEM INTERVENTION WORK AND THEN 727 00:32:34,990 --> 00:32:37,159 YOU HAVE TO DO THE SEPARATE 728 00:32:37,159 --> 00:32:38,894 ANALYSIS IF YOU'RE A 729 00:32:38,894 --> 00:32:39,561 QUANTITATIVE PERSON THE 730 00:32:39,561 --> 00:32:41,196 STRATIFIED ANALYSIS WE SAY AND 731 00:32:41,196 --> 00:32:43,932 YOU HAVE TO REPORT SEPARATELY 732 00:32:43,932 --> 00:32:46,001 OTHERWISE YOU DON'T KNOW IF MEN 733 00:32:46,001 --> 00:32:47,035 AND WOMEN HAVE A DIFFERENT 734 00:32:47,035 --> 00:32:55,344 EFFECT. 735 00:32:55,344 --> 00:32:56,979 SOCIETAL CONCERN YOU HAVE TO DO 736 00:32:56,979 --> 00:32:58,880 DIFFERENTLY AND PEOPLE START TO 737 00:32:58,880 --> 00:33:00,615 USE DIFFERENT TERMS LIKE HEALTH 738 00:33:00,615 --> 00:33:04,786 EQUITY RELEVANT RANDOMIZED 739 00:33:04,786 --> 00:33:08,323 TRIALS OR EQUITY INFORMATIVE 740 00:33:08,323 --> 00:33:08,557 METHODS. 741 00:33:08,557 --> 00:33:10,826 AND THERE'S TWO APPROACHES. 742 00:33:10,826 --> 00:33:14,763 ONE IS FOCUSSING ON AN EXCLUDED 743 00:33:14,763 --> 00:33:16,765 GROUP AND THE OTHER IS ASSESSING 744 00:33:16,765 --> 00:33:21,837 DIFFERENCES FOR SOCIAL GROUPS. 745 00:33:21,837 --> 00:33:22,904 FOCUSSING ON TRADITIONALLY 746 00:33:22,904 --> 00:33:23,872 EXCLUDED GROUP IS NOT THAT 747 00:33:23,872 --> 00:33:25,507 DIFFERENT IN TERMS OF THE STUDY 748 00:33:25,507 --> 00:33:32,581 DESIGN YOU HAVE TO GO TO THOSE 749 00:33:32,581 --> 00:33:32,981 FRS 750 00:33:32,981 --> 00:33:34,783 TRADITIONALLY EXCLUDED GROUPS. 751 00:33:34,783 --> 00:33:35,584 THE RESEARCHERS WENT TO THE LOW 752 00:33:35,584 --> 00:33:38,453 INCOME NEIGHBORHOOD AND SELECTED 753 00:33:38,453 --> 00:33:39,488 PEOPLE. 754 00:33:39,488 --> 00:33:43,492 AND THEN THE REST IS BUSINESS AS 755 00:33:43,492 --> 00:33:43,959 USUAL. 756 00:33:43,959 --> 00:33:47,129 SO, NOW THE DISTRIBUTIONS CAME 757 00:33:47,129 --> 00:33:49,731 FROM THAT PARTICULAR GROUP AND 758 00:33:49,731 --> 00:33:52,100 THEN YOU SEE INTERVENTION EFFECT 759 00:33:52,100 --> 00:33:54,202 LIKE TRADITIONAL STUDY. 760 00:33:54,202 --> 00:33:55,971 IT'S JUST THE POPULATION IS 761 00:33:55,971 --> 00:34:00,308 DIFFERENT HERE. 762 00:34:00,308 --> 00:34:02,010 BUT A BIT MORE COMPLEX IS 763 00:34:02,010 --> 00:34:04,479 DIFFERENCES FOR SOCIAL GROUPS. 764 00:34:04,479 --> 00:34:06,882 YOU HAVE TO GO TO THE POPULATION 765 00:34:06,882 --> 00:34:09,284 REPRESENTING THE SOCIAL 766 00:34:09,284 --> 00:34:10,385 CHARACTERISTIC OF INTEREST. 767 00:34:10,385 --> 00:34:12,120 IF WE'RE INTERESTED IN INCOME, 768 00:34:12,120 --> 00:34:14,122 YOU NEED LOW INCOME PEOPLE AND 769 00:34:14,122 --> 00:34:15,123 HIGH-INCOME PEOPLE. 770 00:34:15,123 --> 00:34:18,727 YOU CANNOT JUST HAVE A CERTAIN 771 00:34:18,727 --> 00:34:22,030 INCOME PEOPLE. 772 00:34:22,330 --> 00:34:23,665 AND WHEN YOU RUN THE STUDY MAKE 773 00:34:23,665 --> 00:34:25,967 SURE YOU MEASURE IT. 774 00:34:25,967 --> 00:34:26,935 YOU HAVE TO MEASURE INCOME IF 775 00:34:26,935 --> 00:34:32,374 IT'S YOUR INTEREST, RACE, IF 776 00:34:32,374 --> 00:34:37,879 RACE IS THE INTEREST. 777 00:34:37,879 --> 00:34:40,582 EXAMINE THE CHARACTERISTICS AND 778 00:34:40,582 --> 00:34:44,920 THE STUDY WOULD LOOK LIKE THIS. 779 00:34:44,920 --> 00:34:52,394 THIS IS THE STUDY NOW IT'S 780 00:34:52,394 --> 00:34:52,594 ADDED. 781 00:34:52,594 --> 00:34:54,596 THE LOWER INCOME TO HIGHER 782 00:34:54,596 --> 00:34:56,932 INCOME. 783 00:34:56,932 --> 00:34:58,233 THEN WHAT'S THE FIRST. 784 00:34:58,233 --> 00:35:00,902 HERE YOU CAN SEE FOR THE LOW 785 00:35:00,902 --> 00:35:02,637 BIRTH WEIGHT WHAT'S THE 786 00:35:02,637 --> 00:35:04,606 DIFFERENCE BETWEEN INTERVENTION 787 00:35:04,606 --> 00:35:07,375 AND NON-INTERVENTION GROUP. 788 00:35:07,375 --> 00:35:09,444 AND IN THE MIDDLE AND HIGH 789 00:35:09,444 --> 00:35:09,744 INCOME. 790 00:35:09,744 --> 00:35:13,415 SO YOU CAN AT THE DIFFERENT 791 00:35:13,415 --> 00:35:15,617 LEVEL OF INCOME, HOW THE 792 00:35:15,617 --> 00:35:16,885 INTERVENTION EFFECT IS DIFFERENT 793 00:35:16,885 --> 00:35:19,087 AND YOU CAN REPORT THAT. 794 00:35:19,087 --> 00:35:21,389 SO FOR THIS HYPOTHETICAL STUDY 795 00:35:21,389 --> 00:35:23,558 IS A WONDERFUL STUDY BECAUSE THE 796 00:35:23,558 --> 00:35:25,861 LOWER THE INCOME IS THE GREATER 797 00:35:25,861 --> 00:35:29,998 THE INTERVENTION EFFECT IS. 798 00:35:29,998 --> 00:35:31,466 IF YOU DIDN'T MEASURE INCOME YOU 799 00:35:31,466 --> 00:35:34,636 CAN'T DO THIS. 800 00:35:34,636 --> 00:35:35,770 AND SO YOU NEED TO PLAN IN 801 00:35:35,770 --> 00:35:37,839 ADVANCE OF WHAT YOU WANT TO LOOK 802 00:35:37,839 --> 00:35:43,678 FOR AND HOW TO ANALYZE IT AND 803 00:35:43,678 --> 00:35:46,381 HOW TO REPORT. 804 00:35:46,381 --> 00:35:48,049 SO THERE'S SOME CHALLENGES FOR 805 00:35:48,049 --> 00:35:49,784 EQUITY RELEVANT AND INFORMATIVE 806 00:35:49,784 --> 00:35:50,018 STUDIES. 807 00:35:50,018 --> 00:35:54,456 ONE IS SAMPLE SIZE. 808 00:35:54,456 --> 00:35:56,758 BECAUSE IT'S INDICATING A SOCIAL 809 00:35:56,758 --> 00:35:58,093 DISADVANTAGE ARE USUALLY SMALL. 810 00:35:58,093 --> 00:36:01,429 LARGE SAMPLE SIZE IS NEEDED FOR 811 00:36:01,429 --> 00:36:03,431 TYPICALLY SMALL GROUPS. 812 00:36:03,431 --> 00:36:05,967 WE ARE INTERESTED IN SEXUAL 813 00:36:05,967 --> 00:36:07,936 MINORITY GROUPS AND RACIAL 814 00:36:07,936 --> 00:36:10,906 MINORITY GROUPS AND BY 815 00:36:10,906 --> 00:36:11,673 DEFINITION MINORITY OF SMALL 816 00:36:11,673 --> 00:36:16,511 GROUP AND YOU HAVE TO THE 817 00:36:16,511 --> 00:36:16,745 NUMBER. 818 00:36:16,745 --> 00:36:18,013 AS LONG AS SOCIAL 819 00:36:18,013 --> 00:36:19,981 CHARACTERISTICS ARE REPORTED 820 00:36:19,981 --> 00:36:24,519 STATUS CAN BE REPORTED RELEVANT 821 00:36:24,519 --> 00:36:27,889 INFORMATIVE POST HOC. 822 00:36:27,889 --> 00:36:28,657 MEANING IF YOU MEASURE AND 823 00:36:28,657 --> 00:36:31,393 REPORT IT AND IF YOU PUBLISH THE 824 00:36:31,393 --> 00:36:33,228 STUDY, LATER PEOPLE CAN GO BACK 825 00:36:33,228 --> 00:36:37,632 AND CHECK IT AGAIN. 826 00:36:37,632 --> 00:36:39,534 AND THERE'S QUITE EXCITING 827 00:36:39,534 --> 00:36:41,636 QUANTITATIVE METHODS HOW TO DO 828 00:36:41,636 --> 00:36:41,903 IT. 829 00:36:41,903 --> 00:36:44,773 COMBINING DATA FROM MANY STUDIES 830 00:36:44,773 --> 00:36:45,507 PLUS MEGA ANALYSIS. 831 00:36:45,507 --> 00:36:48,910 YOUR STUDY MAY BE VERY SMALL BUT 832 00:36:48,910 --> 00:36:57,352 YOU COULD COMBINE LATER. 833 00:36:57,352 --> 00:36:59,221 ALSO THERE'S BAYESIAN METHODS 834 00:36:59,221 --> 00:37:00,922 OVERCOMING THOSE ISSUES. 835 00:37:00,922 --> 00:37:04,092 IT'S WONDERFUL IF YOU CAN DESIGN 836 00:37:04,092 --> 00:37:08,430 VERY LARGE STUDY THAT'S ENOUGH 837 00:37:08,430 --> 00:37:10,131 POWER TO DETECT THOSE SMALL 838 00:37:10,131 --> 00:37:12,934 DIFFERENCES OF THE SMALL GROUPS. 839 00:37:12,934 --> 00:37:15,537 IF YOU CANNOT, STILL MEASURE 840 00:37:15,537 --> 00:37:18,673 THOSE CHARACTERISTICS THEN YOU 841 00:37:18,673 --> 00:37:21,009 CAN HELP OTHER RESEARCHERS TO 842 00:37:21,009 --> 00:37:25,880 KIND OF COMBINE THE POWER LATER. 843 00:37:25,880 --> 00:37:31,019 COST COULD BE THE ISSUE BECAUSE 844 00:37:31,019 --> 00:37:37,459 YOU HAVE TO GO TO INVITED AND 845 00:37:37,459 --> 00:37:43,265 WILLING TO PARTICIPATE BUT HIP 846 00:37:43,265 --> 00:37:45,767 GUIDELINES AND RESEARCHERS WRITE 847 00:37:45,767 --> 00:37:48,136 THE GRANTS AND JUSTIFY WE WANT 848 00:37:48,136 --> 00:37:50,105 TO DO THIS STUDY AND IT'S MORE 849 00:37:50,105 --> 00:37:52,907 EXPENSIVE AND THEY WANT TO GO 850 00:37:52,907 --> 00:37:54,976 INTO THOSE DIFFICULT TO REACH 851 00:37:54,976 --> 00:37:57,379 POPULATION FOR THE SOCIETAL 852 00:37:57,379 --> 00:37:57,646 CONCERNS. 853 00:37:57,646 --> 00:38:00,915 NIH POLICY IS SURE, WE'LL DO IT 854 00:38:00,915 --> 00:38:02,017 BECAUSE IT'S IMPORTANT. 855 00:38:02,017 --> 00:38:04,419 SO COST SHOULD NOT BE THE 856 00:38:04,419 --> 00:38:07,889 REASON. 857 00:38:07,889 --> 00:38:15,730 I THINK THE IDEAL IS GOOD TO 858 00:38:15,730 --> 00:38:18,400 THINK ABOUT AND YOU CAN SEE IN 859 00:38:18,400 --> 00:38:21,336 MY DIAGRAM THE EQUITY RELEVANT 860 00:38:21,336 --> 00:38:24,906 STUDIES GET FAIRLY COMPLEX HOW 861 00:38:24,906 --> 00:38:26,274 YOU DESIGN IT. 862 00:38:26,274 --> 00:38:28,476 SO, THE SUMMARY. 863 00:38:28,476 --> 00:38:30,011 WE ASK THREE GUIDING QUESTIONS, 864 00:38:30,011 --> 00:38:32,213 WHO SHOULD BE IN THE STUDY AND 865 00:38:32,213 --> 00:38:32,914 WHY. 866 00:38:32,914 --> 00:38:34,015 DIFFERENT REASONS. 867 00:38:34,015 --> 00:38:39,487 AND WHICH HOUSING EQUALITIES ARE 868 00:38:39,487 --> 00:38:42,324 UNFAIR AND HOW DO THEY INFLUENCE 869 00:38:42,324 --> 00:38:45,794 THE ANALYSIS PLAN AND REPORTING. 870 00:38:45,794 --> 00:38:48,463 I HOPE THIS KEY POINTS I WANTED 871 00:38:48,463 --> 00:38:50,031 TO MAKE ARE NOW CLEAR. 872 00:38:50,031 --> 00:38:51,666 EQUITY CONSIDERATIONS ARE NOT 873 00:38:51,666 --> 00:38:53,335 THE CHECK BOX AND THEY'RE WOVEN 874 00:38:53,335 --> 00:38:55,970 INTO THE PRINCIPLES FOR ETHICAL, 875 00:38:55,970 --> 00:38:59,040 CLINICAL RESEARCH AND TO MAKE 876 00:38:59,040 --> 00:38:59,874 EQUITY CONTRIBUTIONS EXPLICIT 877 00:38:59,874 --> 00:39:04,913 AND MEANINGFUL IT'S IMPORTANT TO 878 00:39:04,913 --> 00:39:07,048 THINK CAREFULLY ABOUT WHEN 879 00:39:07,048 --> 00:39:09,718 HOUSING INEQUALITIES ARE THERE. 880 00:39:09,718 --> 00:39:10,652 >> THANK YOU VERY MUCH. 881 00:39:10,652 --> 00:39:12,654 WE HAVE 10 MINUTES FOR 882 00:39:12,654 --> 00:39:13,888 QUESTIONS. 883 00:39:13,888 --> 00:39:17,225 AS A REMINDER FOR THOSE IN THE 884 00:39:17,225 --> 00:39:18,193 ROOM, PLEASE HEAD TO THE 885 00:39:18,193 --> 00:39:18,493 MICROPHONES. 886 00:39:18,493 --> 00:39:19,861 WE HAVE A QUESTION FROM VIDEO 887 00:39:19,861 --> 00:39:24,132 LAND WE CAN START WITH. 888 00:39:24,132 --> 00:39:26,801 SO, THIS IS BACK TO YOUR 889 00:39:26,801 --> 00:39:27,202 DEFINITIONS. 890 00:39:27,202 --> 00:39:29,504 AND SO HERE'S THE QUESTION FROM 891 00:39:29,504 --> 00:39:30,138 JAKE. 892 00:39:30,138 --> 00:39:33,541 COULD YOU GIVE AN EXAMPLE OF A 893 00:39:33,541 --> 00:39:36,144 HEALTH INEQUITY THAT IS NOT A 894 00:39:36,144 --> 00:39:37,879 HEALTH DISPARITY? 895 00:39:37,879 --> 00:39:40,215 SO, HE'S ASKING YOU HAVE A GREEN 896 00:39:40,215 --> 00:39:42,183 AND THEN AN OLIVE. 897 00:39:42,183 --> 00:39:45,820 ARE THERE -- WHAT'S IN THE GREEN 898 00:39:45,820 --> 00:39:48,189 CIRCLE VERSUS WHAT'S IN THE 899 00:39:48,189 --> 00:39:48,757 OLIVE CIRCLE? 900 00:39:48,757 --> 00:39:49,290 >> THAT'S AN INTERESTING 901 00:39:49,290 --> 00:39:59,467 QUESTION. 902 00:40:03,772 --> 00:40:04,906 THERE ARE DIFFERENT 903 00:40:04,906 --> 00:40:06,975 PHILOSOPHICAL PERSPECTIVES TO 904 00:40:06,975 --> 00:40:07,509 DEFINE HEALTH INEQUITY. 905 00:40:07,509 --> 00:40:13,248 I GIVE YOU ONE OR TWO. 906 00:40:13,248 --> 00:40:16,451 SO ONE IS THAT EQUAL OPPORTUNITY 907 00:40:16,451 --> 00:40:21,022 FOR HEALTH AND FOR PHILOSOPHERS 908 00:40:21,022 --> 00:40:24,292 IN THE ROOM AND WHAT'S WRONG 909 00:40:24,292 --> 00:40:27,162 ABOUT IT IS THOSE FACTORS BEYOND 910 00:40:27,162 --> 00:40:30,064 INDIVIDUAL CONTROL. 911 00:40:30,064 --> 00:40:32,600 THOSE ARE INEQUITY AS SOMETHING 912 00:40:32,600 --> 00:40:34,469 WITHIN YOUR CONTROL AND 913 00:40:34,469 --> 00:40:36,971 SOMETHING THAT HAPPENS. 914 00:40:36,971 --> 00:40:39,407 TYPICAL EXAMPLE I GIVE IS YOU 915 00:40:39,407 --> 00:40:44,345 DON'T NEED TO BUT YOU INSISTED 916 00:40:44,345 --> 00:40:47,215 AND YOU DID BUNGIE JUMPING 917 00:40:47,215 --> 00:40:48,249 WITHOUT SAFETY PRECAUTION AND 918 00:40:48,249 --> 00:40:49,851 DIDN'T NEED TO. 919 00:40:49,851 --> 00:40:50,718 IT'S YOUR CHOICE. 920 00:40:50,718 --> 00:40:54,889 AND YOU HAPPEN TO JUST BREAK 921 00:40:54,889 --> 00:40:59,060 YOUR LEG THEN TOO BAD, I'M SORRY 922 00:40:59,060 --> 00:41:00,495 THAT HAPPENED BUT MAYBE 923 00:41:00,495 --> 00:41:01,129 SOCIETY'S NOT RESPONSIBLE FOR 924 00:41:01,129 --> 00:41:08,636 WHAT YOU DID. 925 00:41:08,636 --> 00:41:10,171 BUT THAT HEALTH IS OKAY. 926 00:41:10,171 --> 00:41:11,606 SOMETHING LIKE THAT. 927 00:41:11,606 --> 00:41:13,374 YOU COULD THINK ABOUT IT. 928 00:41:13,374 --> 00:41:16,544 IN THAT VIEW, THE DISTINCTION IS 929 00:41:16,544 --> 00:41:20,582 NOT SO MUCH WHICH GROUP. 930 00:41:20,582 --> 00:41:22,750 SO YOU CAN IMAGINE EVEN LOWER 931 00:41:22,750 --> 00:41:24,786 INCOME PEOPLE WITHIN THEM, THE 932 00:41:24,786 --> 00:41:28,656 PEOPLE WHO DID BUNGIE AND NOT 933 00:41:28,656 --> 00:41:31,793 BUNGIE JUMPING THERE'S 934 00:41:31,793 --> 00:41:32,093 DIFFERENCES. 935 00:41:32,093 --> 00:41:40,902 IT DOESN'T UNIQUELY FIT INTO THE 936 00:41:40,902 --> 00:41:47,475 GROUPS. 937 00:41:47,475 --> 00:41:51,412 AND THAT'S THE CORE PART. 938 00:41:51,412 --> 00:41:52,580 >> SO JAKE LET US KNOW IF YOU 939 00:41:52,580 --> 00:41:54,349 HAVE A FOLLOW-UP. 940 00:41:54,349 --> 00:41:55,083 AND REMA. 941 00:41:55,083 --> 00:42:02,423 >> THANK YOU FOR YOUR TALK. 942 00:42:02,423 --> 00:42:06,427 I HAVE A QUESTION ABOUT 943 00:42:06,427 --> 00:42:07,762 INTERSECTIONALITY BECAUSE IT 944 00:42:07,762 --> 00:42:10,298 SEEMS THE PAST 10, 20 YEARS WE 945 00:42:10,298 --> 00:42:12,400 STARTED TO TALK ABOUT HOW PEOPLE 946 00:42:12,400 --> 00:42:14,402 CAN BE A PART OF MORE THAN ONE 947 00:42:14,402 --> 00:42:14,602 GROUP. 948 00:42:14,602 --> 00:42:15,970 WHEN RESEARCHERS ARE DOING A 949 00:42:15,970 --> 00:42:18,940 STUDY ABOUT THE EFFECTS OF 950 00:42:18,940 --> 00:42:20,074 INCOME ON SOME OTHER THING IT 951 00:42:20,074 --> 00:42:25,313 SEEMS LIKE IN ADDITION TO IN 952 00:42:25,313 --> 00:42:26,948 ADDITION TO GROUPING BY LOW 953 00:42:26,948 --> 00:42:28,983 INCOME AND MIDDLE INCOME AND 954 00:42:28,983 --> 00:42:32,253 HIGH INCOME THERE SHOULD BE 955 00:42:32,253 --> 00:42:34,222 UNDERSTANDING OF THE GENDER 956 00:42:34,222 --> 00:42:35,490 INFLUENCES INCOME OR MAYBE 957 00:42:35,490 --> 00:42:37,458 DISABILITY INFLUENCES INCOME. 958 00:42:37,458 --> 00:42:42,530 HOW ARE RESEARCHERS TEASING 959 00:42:42,530 --> 00:42:47,402 APART THOSE ISSUES AND HOW ARE 960 00:42:47,402 --> 00:42:49,904 THEY MAPPING ON MAYBE LIKE 961 00:42:49,904 --> 00:42:52,140 LOOKING BACK AT THE COMPLEX 962 00:42:52,140 --> 00:42:54,809 INTERACTS BETWEEN GROUPS? 963 00:42:54,809 --> 00:43:02,917 >> THAT'S A VERY GOOD QUESTION. 964 00:43:02,917 --> 00:43:04,919 THERE'S DIFFERENT WAYS TO ANSWER 965 00:43:04,919 --> 00:43:07,455 IT. 966 00:43:07,455 --> 00:43:10,024 WHO ARE THE RESEARCHERS WE'RE 967 00:43:10,024 --> 00:43:11,793 TALKING ABOUT? 968 00:43:11,793 --> 00:43:16,130 SO THOSE WE'RE INTERESTED IN 969 00:43:16,130 --> 00:43:21,603 EMPIRICAL WORK LIKE TRIALS, AS I 970 00:43:21,603 --> 00:43:24,472 SAID, THE CHOICE OF GROUPS ARE 971 00:43:24,472 --> 00:43:26,708 OFTEN JUST INTUITIVE. 972 00:43:26,708 --> 00:43:29,310 SO THEY'RE NOT VERY INTERESTED 973 00:43:29,310 --> 00:43:30,345 IN GENDER. 974 00:43:30,345 --> 00:43:31,112 I'M INTERESTED IN RACE AND LET'S 975 00:43:31,112 --> 00:43:37,986 DO THAT. 976 00:43:37,986 --> 00:43:39,187 NOTHING WRONG ABOUT IT BUT 977 00:43:39,187 --> 00:43:43,725 THERE'S ALL THINGS YOU CAN 978 00:43:43,725 --> 00:43:44,892 CONSIDER AND SIT DOWN AND COME 979 00:43:44,892 --> 00:43:52,567 UP WITH A THEORY AND PICK THE 980 00:43:52,567 --> 00:43:56,904 IMPORTANT ONE AND ALSO AND EVEN 981 00:43:56,904 --> 00:44:01,976 NOW MEASURING SEX IS GETTING 982 00:44:01,976 --> 00:44:03,611 VERY COMPLEX HOW TO MEASURE. 983 00:44:03,611 --> 00:44:05,546 SO DO WE HAVE THE DATA OR DO WE 984 00:44:05,546 --> 00:44:06,814 KNOW HOW TO MEASURE. 985 00:44:06,814 --> 00:44:13,421 THAT BECOMES THE CONSIDERATION. 986 00:44:13,421 --> 00:44:18,493 ALSO TYPICALLY HAVE THEIR 987 00:44:18,493 --> 00:44:19,394 OWN-ISM. 988 00:44:19,394 --> 00:44:22,196 I'M INTERESTED IN SEXISM. 989 00:44:22,196 --> 00:44:23,665 I'M INTERESTED IN RACISM. 990 00:44:23,665 --> 00:44:24,899 I'M INTERESTED IN CAPITALISM. 991 00:44:24,899 --> 00:44:27,769 THEY'RE JUST GOING TO ONE. 992 00:44:27,769 --> 00:44:33,341 AND THEN IT'S VERY DIFFICULT TO 993 00:44:33,341 --> 00:44:37,245 SAY EVERYTHING IS IMPORTANT AND 994 00:44:37,245 --> 00:44:38,312 WHICH DO YOU CHOOSE AND THAT'S 995 00:44:38,312 --> 00:44:40,915 NOT THE WAY THE EMPIRICAL WORK 996 00:44:40,915 --> 00:44:41,482 GOES. 997 00:44:41,482 --> 00:44:42,684 I'D LIKE TO HAVE THE 998 00:44:42,684 --> 00:44:45,186 CONVERSATION GOING MORE. 999 00:44:45,186 --> 00:44:47,622 BUT THERE'S A GAP IN HOW TO HAVE 1000 00:44:47,622 --> 00:44:47,989 THE DISCUSSION. 1001 00:44:47,989 --> 00:44:55,596 >> THANK YOU. 1002 00:44:55,596 --> 00:44:56,964 >> THANK YOU AGAIN FOR YOUR 1003 00:44:56,964 --> 00:44:57,231 TALK. 1004 00:44:57,231 --> 00:44:58,366 MY QUESTION IS THE REASONS WHY 1005 00:44:58,366 --> 00:45:00,902 YOU CONDUCT THE STUDY, RIGHT. 1006 00:45:00,902 --> 00:45:03,871 SO IT'S LIKE IN TERMS OF 1007 00:45:03,871 --> 00:45:08,009 PARTICIPATION OR BIOLOGICAL OR 1008 00:45:08,009 --> 00:45:08,609 SOCIAL DIFFERENCES. 1009 00:45:08,609 --> 00:45:15,016 MY QUESTION IS HOI YOU STUDY 1010 00:45:15,016 --> 00:45:16,617 CONFLATING BIOLOGY AND SOCIAL 1011 00:45:16,617 --> 00:45:17,051 ISSUES. 1012 00:45:17,051 --> 00:45:22,256 WE THINK OF THE HISTORY OF 1013 00:45:22,256 --> 00:45:25,426 SCIENCE AND COMPLETING BETWEEN 1014 00:45:25,426 --> 00:45:28,229 BIOLOGY AND SOCIAL HISTORY FOR 1015 00:45:28,229 --> 00:45:28,529 EXAMPLE. 1016 00:45:28,529 --> 00:45:31,566 SO TO GO FURTHER IN DEPTH, A LOT 1017 00:45:31,566 --> 00:45:33,568 OF WAYS LIKE RACE AND GENDER IS 1018 00:45:33,568 --> 00:45:36,003 ONE PRIMARY CONSEQUENCE OF 1019 00:45:36,003 --> 00:45:37,538 COMPLETING THESE TWO REASONS WHY 1020 00:45:37,538 --> 00:45:38,172 WE STUDY. 1021 00:45:38,172 --> 00:45:43,644 FOR EXAMPLE, WE HAVE A HISTORY 1022 00:45:43,644 --> 00:45:45,113 OF CONTRIBUTING INTELLIGENCE FOR 1023 00:45:45,113 --> 00:45:46,914 EXAMPLE TO RACE OR GENDER AND 1024 00:45:46,914 --> 00:45:48,916 THE CONSEQUENCES YOU COULD BE AS 1025 00:45:48,916 --> 00:45:51,586 SIMPLE AS STEREOTYPING TO 1026 00:45:51,586 --> 00:45:54,222 SOMETHING SEVERE LIKE EUGENICS 1027 00:45:54,222 --> 00:45:55,890 MOVEMENT BASED OFF THE SCIENCE 1028 00:45:55,890 --> 00:46:00,895 OF THINKING THERE'S BIOLOGICAL 1029 00:46:00,895 --> 00:46:01,429 DIFFERENCES BETWEEN THESE 1030 00:46:01,429 --> 00:46:06,834 GROUPS. 1031 00:46:06,834 --> 00:46:11,906 AND IS THERE KNOWING THERE'S A 1032 00:46:11,906 --> 00:46:13,341 BIOLOGICAL OR HISTORICAL 1033 00:46:13,341 --> 00:46:14,342 DIFFERENCE AND HOW CAN WE 1034 00:46:14,342 --> 00:46:15,877 COMMUNICATE THE RESULTS IN A WAY 1035 00:46:15,877 --> 00:46:18,946 THAT'S UPLIFTING RATHER THAN 1036 00:46:18,946 --> 00:46:22,583 DEGRADING AND MAKING SURE WE'RE 1037 00:46:22,583 --> 00:46:24,485 CONSCIENCE OF THE DIFFERENCES? 1038 00:46:24,485 --> 00:46:24,986 >> THAT'S A REALLY GOOD 1039 00:46:24,986 --> 00:46:33,594 QUESTION. 1040 00:46:33,594 --> 00:46:35,696 WE JUST HAVE TO BE CRITICAL AND 1041 00:46:35,696 --> 00:46:42,570 CAREFUL. 1042 00:46:42,570 --> 00:46:53,114 IF IT IS YOU CAN ALWAYS SAY THE 1043 00:46:57,718 --> 00:47:04,559 INTELLIGENCE IS THE BIOLOGY AND 1044 00:47:04,559 --> 00:47:07,495 YOU CAN THINK THAT WAY BUT I 1045 00:47:07,495 --> 00:47:08,696 COULD BE WRONG. 1046 00:47:08,696 --> 00:47:11,465 THERE'S DIFFERENT WAYS AND IF IT 1047 00:47:11,465 --> 00:47:14,302 DOESN'T GIVE THE LICENSE, YOU 1048 00:47:14,302 --> 00:47:17,738 CAN DO IT AND IF IT'S A GOOD 1049 00:47:17,738 --> 00:47:24,545 QUESTION AND MAKES SENSE, I 1050 00:47:24,545 --> 00:47:31,953 AGREE WITH YOU AT THE SAME TIME, 1051 00:47:31,953 --> 00:47:33,421 RIGHT NOW WE TRY TO INCLUDE 1052 00:47:33,421 --> 00:47:38,926 DIVERSE POPULATIONS AND DO A 1053 00:47:38,926 --> 00:47:48,569 LITTLE BIT MORE CAREFUL 1054 00:47:48,569 --> 00:47:50,204 EXAMINATION AND WE DIDN'T BEFORE 1055 00:47:50,204 --> 00:47:51,606 AND THAT'S A PROBLEM TOO AND AT 1056 00:47:51,606 --> 00:47:57,845 THE SAME TIME IF YOU HAVE AN 1057 00:47:57,845 --> 00:48:02,950 ASSUMPTION AND START TO PROVE 1058 00:48:02,950 --> 00:48:04,518 THAT AND I KNOW I'M NOT 1059 00:48:04,518 --> 00:48:05,753 ANSWERING BUT I HAVE TO AGREE 1060 00:48:05,753 --> 00:48:08,022 WITH YOU AND YOU HAVE TO BE 1061 00:48:08,022 --> 00:48:08,289 CAREFUL. 1062 00:48:08,289 --> 00:48:10,625 >> TWO QUICK THINGS, RIGHT. 1063 00:48:10,625 --> 00:48:14,028 I THINK TRANSPARENCY AND AS YOU 1064 00:48:14,028 --> 00:48:16,898 SAID, CRITICAL. 1065 00:48:16,898 --> 00:48:18,399 IF YOU'RE LOOKING AT LITERATURE 1066 00:48:18,399 --> 00:48:23,037 IT'S IMPORTANT FOR YOU TO BE 1067 00:48:23,037 --> 00:48:25,172 ABLE TO SAY, OKAY, LET ME THINK 1068 00:48:25,172 --> 00:48:26,974 ABOUT WHAT THEY WERE INTERESTED 1069 00:48:26,974 --> 00:48:28,609 WHEN THEY WERE DESIGNING THE 1070 00:48:28,609 --> 00:48:29,877 STUDY. 1071 00:48:29,877 --> 00:48:34,515 AND LET ME CRITICALLY LOOK AT 1072 00:48:34,515 --> 00:48:36,450 WHETHER OR NOT THEY'RE BASING 1073 00:48:36,450 --> 00:48:42,723 THEIR HYPOTHESIS ON A VERY OLD 1074 00:48:42,723 --> 00:48:44,392 AND INCORRECT ASSUMPTIONS. 1075 00:48:44,392 --> 00:48:49,230 IF YOU DO META-ANALYSIS OR 1076 00:48:49,230 --> 00:48:50,064 SOMETHING, YOU SAY, THAT'S 1077 00:48:50,064 --> 00:48:51,666 GARBAGE TO BE HYPERBOLIC. 1078 00:48:51,666 --> 00:48:56,570 I'M NOT GOING TO INCLUDE THAT IN 1079 00:48:56,570 --> 00:48:58,973 MY META-ANALYSIS BECAUSE THEY 1080 00:48:58,973 --> 00:48:59,607 WEREN'T ASKING AN APPROPRIATE 1081 00:48:59,607 --> 00:49:00,241 QUESTION MAYBE OR SOMETHING LIKE 1082 00:49:00,241 --> 00:49:03,811 THAT. 1083 00:49:03,811 --> 00:49:04,679 >> YEAH. 1084 00:49:04,679 --> 00:49:06,147 SO I THINK IT'S HELPFUL TO GO 1085 00:49:06,147 --> 00:49:07,882 BACK IN PRINCIPLE. 1086 00:49:07,882 --> 00:49:09,951 ONE IS THE VARIABLE SCIENTIFIC 1087 00:49:09,951 --> 00:49:10,318 QUESTION. 1088 00:49:10,318 --> 00:49:10,818 >> YEAH. 1089 00:49:10,818 --> 00:49:13,721 >> AND HERE THE REASON WHY I 1090 00:49:13,721 --> 00:49:16,891 SAID EQUITY CONSIDERATION IS NOT 1091 00:49:16,891 --> 00:49:23,864 A CHECK BOX IT'S WOVEN IN AND IS 1092 00:49:23,864 --> 00:49:25,599 A GOOD EXAMPLE LIKE IF YOU DO 1093 00:49:25,599 --> 00:49:27,835 THIS IT'S FINE. 1094 00:49:27,835 --> 00:49:29,270 YOU HAVE TO THINK WHERE DOES THE 1095 00:49:29,270 --> 00:49:32,039 QUESTION COME FROM? 1096 00:49:32,039 --> 00:49:36,043 IS IT REALLY VARIABLE, SOLID, 1097 00:49:36,043 --> 00:49:38,512 MEANINGFUL QUESTION AND THAT 1098 00:49:38,512 --> 00:49:39,981 ALWAYS NEEDS TO BE EXAMINED. 1099 00:49:39,981 --> 00:49:42,817 >> I'M TAKING THE MODERATOR'S 1100 00:49:42,817 --> 00:49:44,085 PRIVILEGE AND WE HAVE ONE MORE 1101 00:49:44,085 --> 00:49:46,087 QUESTION FROM VIDEO AND THEN 1102 00:49:46,087 --> 00:49:47,355 WE'LL TRANSFER OVER TO ME. 1103 00:49:47,355 --> 00:49:47,955 THIS IS ANOTHER QUESTION FROM 1104 00:49:47,955 --> 00:49:54,795 JAKE. 1105 00:49:54,795 --> 00:49:55,796 CAN EQUITY CONSIDERATIONS 1106 00:49:55,796 --> 00:49:58,032 JUSTIFY NOT CARRYING OUT A STUDY 1107 00:49:58,032 --> 00:49:59,967 DUE TO LIMITED RESOURCES OR 1108 00:49:59,967 --> 00:50:02,003 OTHER FEASIBILITY CONSTRAINTS? 1109 00:50:02,003 --> 00:50:04,638 A STUDY THAT LACKS NECESSARY 1110 00:50:04,638 --> 00:50:06,540 RESOURCES TO SUFFICIENTLY 1111 00:50:06,540 --> 00:50:09,477 MITIGATE RISK OF HARM OR OBTAIN 1112 00:50:09,477 --> 00:50:10,277 ADEQUATE INFORMED CONSENT FROM 1113 00:50:10,277 --> 00:50:11,645 PARTICIPANTS SHOULD NOT BE 1114 00:50:11,645 --> 00:50:12,780 CONDUCTED BUT SHOULD WE EVER 1115 00:50:12,780 --> 00:50:16,917 STOP A STUDY FROM MOVING FORWARD 1116 00:50:16,917 --> 00:50:27,328 DUE TO EQUITY CONCERNS? 1117 00:50:34,168 --> 00:50:36,137 SAY YOU THOUGHT ABOUT WHAT 1118 00:50:36,137 --> 00:50:37,938 GROUPS YOU'LL SAMPLE FROM BUT 1119 00:50:37,938 --> 00:50:40,274 THE SAMPLE SIZE WOULD BE SO 1120 00:50:40,274 --> 00:50:42,243 LARGE YOU CAN'T GET FUNDING TO 1121 00:50:42,243 --> 00:50:44,912 DO THAT LARGE A STUDY SO YOU 1122 00:50:44,912 --> 00:50:48,749 MIGHT HAVE TO COMPROMISE. 1123 00:50:48,749 --> 00:50:51,152 >> AND IS IT OKAY? 1124 00:50:51,152 --> 00:50:51,652 >> YEAH. 1125 00:50:51,652 --> 00:50:55,790 I'M TRYING TO GO BACK TO MY 1126 00:50:55,790 --> 00:50:56,891 SLIDE. 1127 00:50:56,891 --> 00:50:59,126 SO THAT'S HAPPENING. 1128 00:50:59,126 --> 00:51:02,029 IT'S AGAIN ONE -- SORRY, IT'S 1129 00:51:02,029 --> 00:51:04,865 NOT LIKE A BOOK. 1130 00:51:04,865 --> 00:51:07,201 SO BEFORE I THINK IT'S 1131 00:51:07,201 --> 00:51:09,236 IMPOSSIBLE BECAUSE IT'S SO 1132 00:51:09,236 --> 00:51:11,772 EXPENSIVE NOT FEASIBLE AND ALSO 1133 00:51:11,772 --> 00:51:13,774 AS I INDICATED, TYPICALLY IT'S 1134 00:51:13,774 --> 00:51:17,545 NOT A SMALL SAMPLE SIZE BUT 1135 00:51:17,545 --> 00:51:21,248 THESE ARE THE POPULATIONS OFTEN 1136 00:51:21,248 --> 00:51:22,783 FOR HISTORICAL AND GOOD REASON, 1137 00:51:22,783 --> 00:51:26,053 THEY DONT WANT TO PARTICIPATE IN 1138 00:51:26,053 --> 00:51:27,588 THIS STUDY BECAUSE THEY'RE 1139 00:51:27,588 --> 00:51:29,924 SUSPICIOUS AND WHO ARE WE TO 1140 00:51:29,924 --> 00:51:33,360 BLAME BECAUSE WE DID SO WRONG. 1141 00:51:33,360 --> 00:51:37,598 SO JUST TO GET THAT NECESSARY 1142 00:51:37,598 --> 00:51:40,434 SAMPLE IT JUST COSTS MORE. 1143 00:51:40,434 --> 00:51:41,635 YOU NEED MORE EFFORT AND MORE 1144 00:51:41,635 --> 00:51:42,603 PEOPLE TO GO IN AND TALK AND 1145 00:51:42,603 --> 00:51:45,172 IT'S ALL THAT. 1146 00:51:45,172 --> 00:51:47,308 SO WE SAID WE DON'T DO IT 1147 00:51:47,308 --> 00:51:49,743 BECAUSE IT'S SO EXPENSIVE. 1148 00:51:49,743 --> 00:51:51,045 SO I THINK THAT'S NOT RIGHT. 1149 00:51:51,045 --> 00:51:54,014 SO WE HAVE TO PUSH IT. 1150 00:51:54,014 --> 00:51:56,584 IT'S VERY NICE THE NIH SAID IT'S 1151 00:51:56,584 --> 00:51:59,286 NOT A CONCERN THEN YOU CAN WRITE 1152 00:51:59,286 --> 00:52:02,056 THE GRANT AND YOU JUSTIFY WE 1153 00:52:02,056 --> 00:52:05,960 NEED THESE PEOPLE BECAUSE WE 1154 00:52:05,960 --> 00:52:07,561 HAVE THIS CONCERN AND WE NEED 1155 00:52:07,561 --> 00:52:09,763 THIS MUCH MONEY AND GIVE US 1156 00:52:09,763 --> 00:52:11,165 MONEY AND THEY SHOULD GET THE 1157 00:52:11,165 --> 00:52:16,437 MONEY SO THAT'S GOOD BUT AT THE 1158 00:52:16,437 --> 00:52:18,239 SAME TIME, THERE ARE MANY 1159 00:52:18,239 --> 00:52:20,875 METHODOLOGIES YOU CAN PRODUCE. 1160 00:52:20,875 --> 00:52:24,912 I TALK ABOUT META-ANALYSIS AND 1161 00:52:24,912 --> 00:52:26,080 BAYESIAN METHODS SO THOSE ARE 1162 00:52:26,080 --> 00:52:28,249 THINGS THE RESEARCHER TRIED BUT 1163 00:52:28,249 --> 00:52:29,517 STILL NOT SUFFICIENT BUT MAYBE 1164 00:52:29,517 --> 00:52:31,552 COLLECTIVELY WE COULD STILL MAKE 1165 00:52:31,552 --> 00:52:32,686 SOME DIFFERENCE. 1166 00:52:32,686 --> 00:52:33,754 IT'S NOT EITHER/OR. 1167 00:52:33,754 --> 00:52:35,523 I THINK WE HAVE TO DO EVERYTHING 1168 00:52:35,523 --> 00:52:40,427 WE COULD DO. 1169 00:52:40,427 --> 00:52:41,095 >> YEAH. 1170 00:52:41,095 --> 00:52:44,331 A 1171 00:52:44,331 --> 00:52:46,066 AND COST CAN'T BE AN ISSUE BUT 1172 00:52:46,066 --> 00:52:46,767 THERE ARE FINITE RESOURCES AND 1173 00:52:46,767 --> 00:52:50,070 SAY WE DESIGN A STUDY THAT IS 1174 00:52:50,070 --> 00:52:53,307 GOING TO COST $5 MILLION AND 1175 00:52:53,307 --> 00:52:55,509 FIVE OTHER STUDIES THAT COST $1 1176 00:52:55,509 --> 00:52:57,311 MILLION TO REINFORCE IT'S NOT AN 1177 00:52:57,311 --> 00:52:58,579 EASY ANSWER. 1178 00:52:58,579 --> 00:53:00,915 GREAT, THANK YOU VERY MUCH. 1179 00:53:00,915 --> 00:53:09,957 >> THANK YOU. 1180 00:53:09,957 --> 00:53:12,927 >> NOW YOU'LL GET TO HEAR FROM 1181 00:53:12,927 --> 00:53:14,862 ME AND YOU'LL HEAR FROM ME AND 1182 00:53:14,862 --> 00:53:16,897 BEING TRANSPARENT I WAS EXCITED 1183 00:53:16,897 --> 00:53:26,273 ABOUT TODAY'S LECTURES AN I'M 1184 00:53:26,273 --> 00:53:28,375 GOING TO TRY TO WEAVE THE IDEAS 1185 00:53:28,375 --> 00:53:35,149 TOGETHER AND YUKIKO WILL GIVE US 1186 00:53:35,149 --> 00:53:35,449 BACKGROUND. 1187 00:53:35,449 --> 00:53:38,452 DR. LANGFORD WILL TALK ABOUT 1188 00:53:38,452 --> 00:53:38,786 PARTICIPATION. 1189 00:53:38,786 --> 00:53:40,554 I'LL TRY TO WEAVE THOSE TOGETHER 1190 00:53:40,554 --> 00:53:42,990 A BIT BY TALKING A LITTLE BIT 1191 00:53:42,990 --> 00:53:44,425 MORE ABOUT ETHICS AND A LITTLE 1192 00:53:44,425 --> 00:53:45,326 MORE ABOUT POLICY. 1193 00:53:45,326 --> 00:53:52,900 AND WE'RE ALSO TODAY GOING TO DO 1194 00:53:52,900 --> 00:53:54,101 SOME SLIDO. 1195 00:53:54,101 --> 00:53:57,037 SO HERE'S MY DISCLAIMER. 1196 00:53:57,037 --> 00:53:59,139 YOU ALWAYS GET TO SEE THERE IS A 1197 00:53:59,139 --> 00:54:06,847 PLACE IN MY LECTURE WHERE WE'RE 1198 00:54:06,847 --> 00:54:09,316 GOING TO DO A SLIDO QUIZ. 1199 00:54:09,316 --> 00:54:11,051 IT'S EASY FROM YOUR END. 1200 00:54:11,051 --> 00:54:14,054 GO TO SLIDO.COM ON YOUR PHONE OR 1201 00:54:14,054 --> 00:54:15,356 COMPUTER DEPENDING ON WHERE YOU 1202 00:54:15,356 --> 00:54:17,358 ARE AND IT WILL POP UP AND SAY 1203 00:54:17,358 --> 00:54:19,059 WHAT'S YOUR NUMBER, WHAT'S YOUR 1204 00:54:19,059 --> 00:54:19,260 CODE. 1205 00:54:19,260 --> 00:54:20,894 AND THIS IS THE CODE YOU'RE 1206 00:54:20,894 --> 00:54:25,532 GOING TO PUT IN 2997361. 1207 00:54:25,532 --> 00:54:27,968 SO WHEN WE GET TO THAT PART OF 1208 00:54:27,968 --> 00:54:30,070 MY LECTURE I'M GOING TO ENGAGE A 1209 00:54:30,070 --> 00:54:33,240 QUIZ AND GET YOUR RESPONSES. 1210 00:54:33,240 --> 00:54:36,777 SO I'M GOING TO TRY TO DO THIS 1211 00:54:36,777 --> 00:54:40,314 AND TRY TO MULTI TASK. 1212 00:54:40,314 --> 00:54:42,549 AS I SAID I'M GOING TO TALK MORE 1213 00:54:42,549 --> 00:54:43,684 ABOUT FAIR PARTICIPANT SELECTION 1214 00:54:43,684 --> 00:54:47,121 FROM A BROADER ETHICAL CONTEXT 1215 00:54:47,121 --> 00:54:48,956 THAN INEQUITIES AND DISPARITIES 1216 00:54:48,956 --> 00:54:52,059 AND THEN TALK A BIT MORE ABOUT 1217 00:54:52,059 --> 00:54:57,631 POLICY THE BACKGROUND POLICIES 1218 00:54:57,631 --> 00:55:00,434 THAT YUKIKO HAS MENTIONED AND 1219 00:55:00,434 --> 00:55:02,636 FROM LANGFORD WILL ALSO MENTION. 1220 00:55:02,636 --> 00:55:04,538 SOME REPETITION BUT ALSO WITH 1221 00:55:04,538 --> 00:55:06,774 THE GOAL OF GIVING YOU A NICE 1222 00:55:06,774 --> 00:55:10,411 PACKAGE OF CONTENT TODAY. 1223 00:55:10,411 --> 00:55:12,012 SO, BACK TO THE FIRST DAY WE 1224 00:55:12,012 --> 00:55:14,381 TALKED ABOUT THE BELMONT REPORT. 1225 00:55:14,381 --> 00:55:16,750 AND THE BELMONT REPORT HAS THREE 1226 00:55:16,750 --> 00:55:19,486 ETHICAL PRINCIPLES AS YOU MIGHT 1227 00:55:19,486 --> 00:55:19,753 REMEMBER. 1228 00:55:19,753 --> 00:55:21,288 THE THIRD BEING JUSTICE. 1229 00:55:21,288 --> 00:55:24,591 AND ACCORDING TO THE BELMONT 1230 00:55:24,591 --> 00:55:26,694 REPORT THERE ARE AT LEAST TWO 1231 00:55:26,694 --> 00:55:30,164 THINGS THAT RESEARCHERS SHOULD 1232 00:55:30,164 --> 00:55:33,901 HAVE IN MIND WHEN EXHIBITING 1233 00:55:33,901 --> 00:55:36,737 FAIRNESS AND JUST A SIDE NOTE, 1234 00:55:36,737 --> 00:55:38,005 WHEN YOU'RE READING TERMS LIKE 1235 00:55:38,005 --> 00:55:40,207 FAIRNESS, JUSTICE, IT'S ALWAYS 1236 00:55:40,207 --> 00:55:43,077 IMPORTANT TO THINK ABOUT, WELL, 1237 00:55:43,077 --> 00:55:45,279 WHAT TRADITION ARE THEY COMING 1238 00:55:45,279 --> 00:55:46,914 FROM OR WHAT PERSPECTIVE ARE 1239 00:55:46,914 --> 00:55:49,683 THEY COMING FROM AND THAT MAY 1240 00:55:49,683 --> 00:55:50,351 INFLUENCE HOW THEY'RE SETTING 1241 00:55:50,351 --> 00:55:53,320 THINGS UP JUST A QUICK SIDE 1242 00:55:53,320 --> 00:55:53,620 NOTE. 1243 00:55:53,620 --> 00:55:55,189 SO, INDIVIDUAL JUSTICE IS ONE 1244 00:55:55,189 --> 00:55:57,658 THING THEY MENTIONED. 1245 00:55:57,658 --> 00:56:00,894 AND THAT'S ABOUT HOW A 1246 00:56:00,894 --> 00:56:02,296 RESEARCHER EXHIBITS HIS OR HER 1247 00:56:02,296 --> 00:56:02,830 FAIRNESS. 1248 00:56:02,830 --> 00:56:04,865 AND A QUICK WAY TO SAY THAT IS 1249 00:56:04,865 --> 00:56:08,369 SOMETHING LIKE, IF I'M A P.I., I 1250 00:56:08,369 --> 00:56:10,237 DON'T OFFER THE RISKY TRIALS TO 1251 00:56:10,237 --> 00:56:11,805 PEOPLE I DON'T LIKE AND THE 1252 00:56:11,805 --> 00:56:13,207 POTENTIALLY BENEFICIAL TRIALS TO 1253 00:56:13,207 --> 00:56:16,777 THE PEOPLE I DO LIKE, RIGHT? 1254 00:56:16,777 --> 00:56:20,714 I SHOULDN'T BE MAKING INDIVIDUAL 1255 00:56:20,714 --> 00:56:22,950 DECISIONS ON MORALLY IRRELEVANT 1256 00:56:22,950 --> 00:56:25,419 CONCERNS WHETHER I LIKE SOMEONE 1257 00:56:25,419 --> 00:56:27,254 OR NOT IS NOT A MORALLY RELEVANT 1258 00:56:27,254 --> 00:56:30,224 CONCERN I SHOULD HAVE IN MIND 1259 00:56:30,224 --> 00:56:31,358 WHEN I'M RECRUITING PEOPLE TO 1260 00:56:31,358 --> 00:56:36,897 JOIN MY STUDY. 1261 00:56:36,897 --> 00:56:37,664 THE OTHER IS THE DISTINCTION 1262 00:56:37,664 --> 00:56:40,134 BETWEEN CLASSES AND WE TALKED 1263 00:56:40,134 --> 00:56:42,169 ABOUT THIS LAST WEEK WITH 1264 00:56:42,169 --> 00:56:44,271 PROFESSOR SHAW'S LECTURE WHERE 1265 00:56:44,271 --> 00:56:46,306 THERE CAN BE A DISTINCTION DRAWN 1266 00:56:46,306 --> 00:56:48,208 BETWEEN CLASSES OF SUBJECTS. 1267 00:56:48,208 --> 00:56:55,249 AND SO GOOD EXAMPLE HERE IS WHEN 1268 00:56:55,249 --> 00:56:56,750 WE THINK OF ENROLL BEING 1269 00:56:56,750 --> 00:56:58,218 CHILDREN IN RESEARCH, ONE QUICK 1270 00:56:58,218 --> 00:57:00,621 RESPONSE IS, WELL, MAYBE WE 1271 00:57:00,621 --> 00:57:03,323 SHOULD DO THE RESEARCH IN ADULTS 1272 00:57:03,323 --> 00:57:03,924 BEFORE CHILDREN? 1273 00:57:03,924 --> 00:57:07,361 THERE MAY BE REASONS WHY WE CAN 1274 00:57:07,361 --> 00:57:08,896 EXPOSE A COMPETENT ADULT TO A 1275 00:57:08,896 --> 00:57:16,069 LEVEL OF RISK THAT HE OR SHE IS 1276 00:57:16,069 --> 00:57:19,907 ABLE TO MAKE AN INFORMED 1277 00:57:19,907 --> 00:57:22,843 DECISION AND WE OUGHT TO DO THAT 1278 00:57:22,843 --> 00:57:25,078 FIRST BEFORE WE ASK A CHILD WHO 1279 00:57:25,078 --> 00:57:27,014 CAN'T MAKE AN INFORMED DECISION 1280 00:57:27,014 --> 00:57:30,117 AND CLASSES OF INDIVIDUALS. 1281 00:57:30,117 --> 00:57:32,753 AND WE COME THEN TO THE 1282 00:57:32,753 --> 00:57:34,321 PRINCIPLES THAT DR. GRADY 1283 00:57:34,321 --> 00:57:36,957 MENTIONS ON THE FIRST DAY TO 1284 00:57:36,957 --> 00:57:39,059 FAIR PARTICIPANT SELECTION. 1285 00:57:39,059 --> 00:57:41,829 AND IT TURNS OUT THAT WE HAVE 1286 00:57:41,829 --> 00:57:44,698 TALKED ABOUT THE FOUR MIDDLE 1287 00:57:44,698 --> 00:57:46,667 CONCEPTS LAST WEEK AND I'M GOING 1288 00:57:46,667 --> 00:57:48,902 TO SPEND A LITTLE BIT OF TIME ON 1289 00:57:48,902 --> 00:57:57,177 THE FIRST AND LAST. 1290 00:57:57,177 --> 00:57:59,012 YUKIKO TALKED ABOUT DISTRIBUTING 1291 00:57:59,012 --> 00:58:02,015 BURDENS AND BENEFITS FAIRLY. 1292 00:58:02,015 --> 00:58:03,650 WHEN THE BELMONT REPORT WAS 1293 00:58:03,650 --> 00:58:07,187 BEING DRAFTED, ONE PHENOMENON 1294 00:58:07,187 --> 00:58:11,258 THEY ARE WERE RESPONDING TO IS 1295 00:58:11,258 --> 00:58:12,926 SOMETHING LIKE THIS, WHILE AT 1296 00:58:12,926 --> 00:58:16,897 THE TIME THIS IS IN THE EARLY 1297 00:58:16,897 --> 00:58:20,200 1970s AND LONG BEFORE, THERE 1298 00:58:20,200 --> 00:58:24,004 WERE PUBLIC AND PRIVATE 1299 00:58:24,004 --> 00:58:24,738 HOSPITALS. 1300 00:58:24,738 --> 00:58:27,641 I'M SURE YOU CAN IMAGINE EVEN 1301 00:58:27,641 --> 00:58:30,077 FROM WATCHING TELEVISION, PUBLIC 1302 00:58:30,077 --> 00:58:32,312 HOSPITAL TEEMING WITH PEOPLE 1303 00:58:32,312 --> 00:58:36,183 LIKELY IN AN URBAN SETTING. 1304 00:58:36,183 --> 00:58:37,885 PRIVATE HOSPITAL MAY ALSO BE IN 1305 00:58:37,885 --> 00:58:42,222 AN URBAN SETTING BUT FANCIER 1306 00:58:42,222 --> 00:58:42,422 ROOMS. 1307 00:58:42,422 --> 00:58:43,657 BASICALLY THE WHO DON'T HAVE THE 1308 00:58:43,657 --> 00:58:45,025 FUNDS GO TO THE PUBLIC. 1309 00:58:45,025 --> 00:58:46,994 THOSE WHO DO HAVE THE FUNDS GO 1310 00:58:46,994 --> 00:58:48,896 TO THE PRIVATE. 1311 00:58:48,896 --> 00:58:51,131 IT USED TO BE THAT A LOT OF 1312 00:58:51,131 --> 00:58:54,001 RESEARCH WAS CONDUCTED IN THE 1313 00:58:54,001 --> 00:58:57,037 PUBLIC HOSPITAL AND THE RESULTS 1314 00:58:57,037 --> 00:59:00,307 MOST QUICKLY MIGHT RUN OVER TO 1315 00:59:00,307 --> 00:59:03,710 THE PUBLIC, MOST QUICKLY WENT TO 1316 00:59:03,710 --> 00:59:04,878 THE PRIVATE PATIENTS IN THE 1317 00:59:04,878 --> 00:59:05,913 PRIVATE HOSPITAL. 1318 00:59:05,913 --> 00:59:07,714 ONE WE THIS WAS THOUGHT ABOUT 1319 00:59:07,714 --> 00:59:13,320 AND THIS IS A BIT OF 1320 00:59:13,320 --> 00:59:14,888 RETROSPECTIVE MORAL ANALYSIS. 1321 00:59:14,888 --> 00:59:18,392 THE IDEA WAS FROM THE PUBLIC 1322 00:59:18,392 --> 00:59:20,027 HOSPITAL PERSPECTIVE WE ARE 1323 00:59:20,027 --> 00:59:21,361 PROVIDING CARE TO THESE PEOPLE 1324 00:59:21,361 --> 00:59:23,096 WHO MIGHT NOT OTHERWISE HAVE 1325 00:59:23,096 --> 00:59:27,634 ACCESS TO CARE. 1326 00:59:27,634 --> 00:59:30,170 SO, INCLUDING THEM IN RESEARCH 1327 00:59:30,170 --> 00:59:33,206 IS THE WAY THEY CAN PAY BACK THE 1328 00:59:33,206 --> 00:59:33,607 ALTRUISM. 1329 00:59:33,607 --> 00:59:34,675 WE CAN HAVE A LONG DISCUSSION 1330 00:59:34,675 --> 00:59:38,078 ABOUT THE PROBLEMS WITH THAT AND 1331 00:59:38,078 --> 00:59:39,513 THE AUTHORS OF BELMONT CLEARLY 1332 00:59:39,513 --> 00:59:41,915 TOOK NOTE AND SAID THAT'S NOT AN 1333 00:59:41,915 --> 00:59:44,751 APPROPRIATE WAY TO THINK ABOUT 1334 00:59:44,751 --> 00:59:44,952 THIS. 1335 00:59:44,952 --> 00:59:46,920 WE OUGHT NOT TO PUT ALL THE 1336 00:59:46,920 --> 00:59:49,623 BURDENS ON ONE GROUP AND HAVE 1337 00:59:49,623 --> 00:59:53,460 ALL THE BENEFITS TRANSFER TO 1338 00:59:53,460 --> 00:59:54,328 ANOTHER. 1339 00:59:54,328 --> 00:59:55,929 WE OUGHT TO BE DOING RESEARCH IN 1340 00:59:55,929 --> 00:59:56,964 ALL PATIENTS EXPOSING ALL OF 1341 00:59:56,964 --> 01:00:00,901 THEM TO THE RISKS AND INCLUDING 1342 01:00:00,901 --> 01:00:02,035 ALL PATIENTS IN THE BENEFITS OF 1343 01:00:02,035 --> 01:00:06,473 THAT RESEARCH. 1344 01:00:06,473 --> 01:00:09,176 NOW, YOU ALL KNOW AT LEAST THOSE 1345 01:00:09,176 --> 01:00:10,310 WHO LIVE IN THE UNITED STATES 1346 01:00:10,310 --> 01:00:14,281 AND ARE FAMILIAR WITH OUR HEALTH 1347 01:00:14,281 --> 01:00:17,217 CARE SYSTEM KNOW THIS WHILE THIS 1348 01:00:17,217 --> 01:00:20,887 IS I THINK TRUE AND WE HAVE MADE 1349 01:00:20,887 --> 01:00:21,688 EFFORTS AND I'LL TALK A LITTLE 1350 01:00:21,688 --> 01:00:26,560 BIT MORE ABOUT THEM, HOW WE HAVE 1351 01:00:26,560 --> 01:00:30,397 INCLUDED MORE PEOPLE IN CLINICAL 1352 01:00:30,397 --> 01:00:33,800 TRIALS, A MORE DIVERSE GROUP AND 1353 01:00:33,800 --> 01:00:35,736 THOSE WHO ARE IN THE TRIAL ARE 1354 01:00:35,736 --> 01:00:37,704 MUCH LIKE ALL THE PATIENTS WHO 1355 01:00:37,704 --> 01:00:41,141 MIGHT THEN BENEFIT, WE HAVE AN 1356 01:00:41,141 --> 01:00:43,844 UNFAIR SYSTEM SO IT'S NOT ALWAYS 1357 01:00:43,844 --> 01:00:44,945 THE CASE THAT ALL PATIENTS 1358 01:00:44,945 --> 01:00:47,247 RECEIVE THE BENEFITS OF 1359 01:00:47,247 --> 01:00:47,514 RESEARCH. 1360 01:00:47,514 --> 01:00:50,417 THAT'S JUST HOW OUR SYSTEM IS. 1361 01:00:50,417 --> 01:00:53,353 BUT WE CAN AT LEAST AGREE THAT 1362 01:00:53,353 --> 01:00:54,955 IN THINKING ABOUT THE BURDENS 1363 01:00:54,955 --> 01:00:59,226 AND BENEFITS OF RESEARCH, THEY 1364 01:00:59,226 --> 01:01:01,461 OUGHT TO BE DISTRIBUTED FAIRLY. 1365 01:01:01,461 --> 01:01:03,730 NOW, LET'S THINK A LITTLE MORE 1366 01:01:03,730 --> 01:01:07,100 ABOUT BURDENS AND BENEFITS. 1367 01:01:07,100 --> 01:01:10,170 THIS GOES BACK TO YUKIKO'S 1368 01:01:10,170 --> 01:01:10,504 PRESENTATION. 1369 01:01:10,504 --> 01:01:13,040 THE SCIENTIFIC GOALS OF THE 1370 01:01:13,040 --> 01:01:14,074 STUDY SHOULD BE THE PRIMARY 1371 01:01:14,074 --> 01:01:14,875 CONSIDERATION IN DETERMINING WHO 1372 01:01:14,875 --> 01:01:18,712 IS ELIGIBLE TO ENROLL RIGHT. 1373 01:01:18,712 --> 01:01:23,750 SO SETTING ALL THOSE OTHER 1374 01:01:23,750 --> 01:01:29,389 THINGS ASIDE, ONE IMPORTANT 1375 01:01:29,389 --> 01:01:31,525 THING IS YOU SHOULD BE 1376 01:01:31,525 --> 01:01:35,095 RECRUITING INDIVIDUALS HE WELIG 1377 01:01:35,095 --> 01:01:37,264 FOR THE STUDY YOU'VE DESIGN AND 1378 01:01:37,264 --> 01:01:38,799 THIS IS A MORE SCIENTIFIC 1379 01:01:38,799 --> 01:01:42,135 PERSPECTIVE AS YUKIKO MENTIONED, 1380 01:01:42,135 --> 01:01:43,336 YOU PLAY HAVE STATISTICAL 1381 01:01:43,336 --> 01:01:44,004 CONSIDERATIONS YOU WANT TO 1382 01:01:44,004 --> 01:01:45,172 ADDRESS AND THINK OF THOSE IN 1383 01:01:45,172 --> 01:01:47,074 THE DESIGN OF YOUR STUDY BECAUSE 1384 01:01:47,074 --> 01:01:48,642 YOU WANT TO DISTRIBUTE THE 1385 01:01:48,642 --> 01:01:52,879 BENEFITS AND BURDENS FAIRLY. 1386 01:01:52,879 --> 01:01:58,185 SO THE GENERALIZABILITY RIGHT. 1387 01:01:58,185 --> 01:02:00,153 THE BROADER THE POPULATION OF 1388 01:02:00,153 --> 01:02:02,022 PARTICIPANTS YOU ENROLL, THE 1389 01:02:02,022 --> 01:02:04,791 MORE LIKELY THE RESULTS OF THAT 1390 01:02:04,791 --> 01:02:07,027 STUDY IS GOING TO BE 1391 01:02:07,027 --> 01:02:09,029 GENERALIZABLE TO THE LARGER 1392 01:02:09,029 --> 01:02:09,596 POPULATION. 1393 01:02:09,596 --> 01:02:12,833 SO THERE'S A GOAL OF ENROLLING A 1394 01:02:12,833 --> 01:02:14,034 BROAD RANGE OF SUBJECTS TO HAVE 1395 01:02:14,034 --> 01:02:16,536 THE FINDINGS OF THE RESEARCH 1396 01:02:16,536 --> 01:02:17,104 APPLY TO AS MANY PEOPLE AS 1397 01:02:17,104 --> 01:02:23,844 POSSIBLE. 1398 01:02:23,844 --> 01:02:26,079 AGAIN, WHAT I'M NOW GOING TO DO 1399 01:02:26,079 --> 01:02:27,080 IS SHIFT A LITTLE BIT AND TALK 1400 01:02:27,080 --> 01:02:29,382 ABOUT PROTECT OF THE VULNERABLE. 1401 01:02:29,382 --> 01:02:31,284 AS I MENTIONED FROM BELMONT WE 1402 01:02:31,284 --> 01:02:34,087 GET THE IDEA THERE'S AN ORDER OF 1403 01:02:34,087 --> 01:02:40,594 PREFERENCE IN SELECTING SUBJECTS 1404 01:02:40,594 --> 01:02:44,097 AND FROM SIOMS WE TALKED ABOUT 1405 01:02:44,097 --> 01:02:46,333 IN THE FIRST DAY AND THE RELATED 1406 01:02:46,333 --> 01:02:51,671 READING IN THE MODULE 1, THAT WE 1407 01:02:51,671 --> 01:02:54,374 SHOULD EXCLUDE VULNERABLE 1408 01:02:54,374 --> 01:02:54,908 SUBJECTS UNLESS THEY'RE 1409 01:02:54,908 --> 01:02:56,510 PARTICIPATION IS NEEDED FOR 1410 01:02:56,510 --> 01:02:57,778 SCIENTIFIC REASONS. 1411 01:02:57,778 --> 01:02:59,813 THIS IS SAYING THIS IN A 1412 01:02:59,813 --> 01:03:00,881 SLIGHTLY DIFFERENT WAY. 1413 01:03:00,881 --> 01:03:04,785 YOU SHOULD ALWAYS HAVE AN ORDER 1414 01:03:04,785 --> 01:03:07,788 UNLESS THERE IS A SCIENTIFIC 1415 01:03:07,788 --> 01:03:09,923 REASON FOR INCLUDING SOMEONE WHO 1416 01:03:09,923 --> 01:03:10,423 WE MIGHT THINK ABOUT AS 1417 01:03:10,423 --> 01:03:15,729 VULNERABLE. 1418 01:03:15,729 --> 01:03:20,200 AND IN GENERAL WHEN WE TALK 1419 01:03:20,200 --> 01:03:21,501 ABOUT VULNERABLE SUBJECTS 1420 01:03:21,501 --> 01:03:22,669 THEY'RE LESS ABLE TO PROTECT 1421 01:03:22,669 --> 01:03:28,041 THEIR OWN INTERESTS. 1422 01:03:28,041 --> 01:03:29,209 THAT'S THE STARTING LINE. 1423 01:03:29,209 --> 01:03:31,044 WHEN WE TALK ABOUT CLINICAL 1424 01:03:31,044 --> 01:03:31,978 RESEARCH, THE VULNERABLE 1425 01:03:31,978 --> 01:03:35,615 SUBJECTS TYPICALLY ARE THOSE WHO 1426 01:03:35,615 --> 01:03:38,084 ARE UNABLE TO GIVE INFORMED 1427 01:03:38,084 --> 01:03:38,318 CONSENT. 1428 01:03:38,318 --> 01:03:41,087 WE'LL TALK MORE ABOUT 1429 01:03:41,087 --> 01:03:44,024 INDIVIDUALS VERSES GROUPS. 1430 01:03:44,024 --> 01:03:45,125 FROM INFORMED CONSENT 1431 01:03:45,125 --> 01:03:46,660 PERSPECTIVE THEY LACK CAPACITY 1432 01:03:46,660 --> 01:03:49,863 OR THEY HAVE CAPACITY BUT ARE 1433 01:03:49,863 --> 01:03:56,803 NOT FREE FROM INFLUENCE. 1434 01:03:56,803 --> 01:03:57,637 TRADITIONALLY OR FROM A 1435 01:03:57,637 --> 01:03:58,672 REGULATORY PERSPECTIVE, THESE 1436 01:03:58,672 --> 01:04:02,042 ARE THE THREE POPULATIONS WHO 1437 01:04:02,042 --> 01:04:03,276 ARE OFFICIALLY VULNERABLE. 1438 01:04:03,276 --> 01:04:08,048 WHAT I MEAN BY OFFICIALLY IS IF 1439 01:04:08,048 --> 01:04:09,449 A SUBJECT WERE A POPULATION OF 1440 01:04:09,449 --> 01:04:10,617 INDIVIDUALS YOU'RE PLANNING TO 1441 01:04:10,617 --> 01:04:15,188 RECRUIT ARE ONE OF THESE THREE 1442 01:04:15,188 --> 01:04:17,991 GROUPS, YOU HAVE EXTRA STEPS IN 1443 01:04:17,991 --> 01:04:19,559 TERMS OF HOW YOU DO THE 1444 01:04:19,559 --> 01:04:20,961 RESEARCH, WHAT TYPE OF RESEARCH 1445 01:04:20,961 --> 01:04:25,398 YOU CAN DO, WHEN YOU HAVE TO 1446 01:04:25,398 --> 01:04:28,535 HAVE ONE PARENT, VERSUS TWO 1447 01:04:28,535 --> 01:04:28,902 PARENT CONSENT. 1448 01:04:28,902 --> 01:04:30,770 THERE'S ADDITIONAL SAFEGUARDS, 1449 01:04:30,770 --> 01:04:32,873 QUOTE, UNQUOTE, WHEN CONDUCTING 1450 01:04:32,873 --> 01:04:36,142 RESEARCH WITH THESE POPULATIONS. 1451 01:04:36,142 --> 01:04:38,278 AND WE TALKED QUITE A BIT ABOUT 1452 01:04:38,278 --> 01:04:40,413 CHILDREN AND PRISONERS ARE AN 1453 01:04:40,413 --> 01:04:42,616 EXAMPLE OF THOSE WHO AGAIN AT 1454 01:04:42,616 --> 01:04:44,317 THE TIME WHEN BELMONT WAS 1455 01:04:44,317 --> 01:04:47,787 WRITTEN AND THEN TRANSLATED INTO 1456 01:04:47,787 --> 01:04:50,824 FEDERAL REGULATIONS, PRISONERS 1457 01:04:50,824 --> 01:04:55,128 WERE CONSIDERED TO HAVE 1458 01:04:55,128 --> 01:04:55,762 CAPACITY. 1459 01:04:55,762 --> 01:04:56,763 LET'S ASSUME THE AVERAGE PERSON 1460 01:04:56,763 --> 01:04:59,299 WHO IS INCARCERATED HAS THE FULL 1461 01:04:59,299 --> 01:05:02,469 CAPACITY TO MAKE A FULLY 1462 01:05:02,469 --> 01:05:05,372 INFORMED DECISION OR AT LEAST A 1463 01:05:05,372 --> 01:05:06,773 GOOD DECISION. 1464 01:05:06,773 --> 01:05:09,809 THEY MAY BE SITUATED IN A WAY 1465 01:05:09,809 --> 01:05:12,846 THAT THEY CAN'T MAKE A DECISION 1466 01:05:12,846 --> 01:05:15,448 FREE FROM INFLUENCE. 1467 01:05:15,448 --> 01:05:17,250 THEY HAVE A LOT OF THEIR CIVIL 1468 01:05:17,250 --> 01:05:18,318 RIGHTS WITHHELD. 1469 01:05:18,318 --> 01:05:19,686 SO WE WANT TO ASK THE QUESTION, 1470 01:05:19,686 --> 01:05:26,059 DOES THE LIMIT ON THEIR CIVIL 1471 01:05:26,059 --> 01:05:30,196 RIGHTS MEAN THAT THEY ARE ARE IN 1472 01:05:30,196 --> 01:05:33,300 A SITUATION WHERE IT WOULD BE 1473 01:05:33,300 --> 01:05:35,802 CHALLENGING TO MAKE AN INFORMED 1474 01:05:35,802 --> 01:05:36,603 DECISION. 1475 01:05:36,603 --> 01:05:38,772 HOW PRISONERS OR THOSE 1476 01:05:38,772 --> 01:05:39,806 INCARCERATED HAVE BEEN 1477 01:05:39,806 --> 01:05:44,077 CONSIDERED AS POTENTIAL RESEARCH 1478 01:05:44,077 --> 01:05:48,882 SUBJECTS HAVE CHANGED OVER TIME 1479 01:05:48,882 --> 01:05:52,285 THERE HAVE BEEN EFFORTS TO 1480 01:05:52,285 --> 01:05:52,852 EXPAND HOUN WE THINK OF 1481 01:05:52,852 --> 01:05:54,220 CONDUCTING RESEARCH WITH 1482 01:05:54,220 --> 01:05:55,989 PRISONERS BUT KEY TO THAT IS 1483 01:05:55,989 --> 01:05:58,692 THERE HAS TO BE SOME REVISION TO 1484 01:05:58,692 --> 01:06:03,763 THE CURRENT FEDERAL REGULATIONS 1485 01:06:03,763 --> 01:06:06,967 AND IT TAKES A LONG TIME TO DO 1486 01:06:06,967 --> 01:06:08,101 THAT BUT THE MIND SET HAS 1487 01:06:08,101 --> 01:06:12,005 CHANGED IN SOME WAYS BUT THE 1488 01:06:12,005 --> 01:06:13,773 REGULATORY SIFE GUARDS, 1489 01:06:13,773 --> 01:06:16,209 GUIDELINES HAVE NOT. 1490 01:06:16,209 --> 01:06:18,945 SO -- SAFEGUARDS, GUIDELINES 1491 01:06:18,945 --> 01:06:20,080 HAVE NOT. 1492 01:06:20,080 --> 01:06:22,716 LET'S TALK MORE ABOUT 1493 01:06:22,716 --> 01:06:23,550 VULNERABILITY. 1494 01:06:23,550 --> 01:06:26,886 THERE'S SOME CASES WHERE IT'S 1495 01:06:26,886 --> 01:06:27,354 POSSIBLE TO ADDRESS 1496 01:06:27,354 --> 01:06:30,223 VULNERABILITY WITHOUT EXCLUDING 1497 01:06:30,223 --> 01:06:30,590 THEM. 1498 01:06:30,590 --> 01:06:31,958 LET ME QUICKLY GO BACK TO THE 1499 01:06:31,958 --> 01:06:32,392 SLIDE. 1500 01:06:32,392 --> 01:06:34,694 I SAID THERE'S AT LEAST TWO WAYS 1501 01:06:34,694 --> 01:06:35,962 TO THINK ABOUT VULNERABLE 1502 01:06:35,962 --> 01:06:38,098 SUBJECTS. 1503 01:06:38,098 --> 01:06:42,569 THEY LACK CAPACITY OR HAVE 1504 01:06:42,569 --> 01:06:44,204 CAPACITY BUT FREE FROM 1505 01:06:44,204 --> 01:06:44,637 INFLUENCE. 1506 01:06:44,637 --> 01:06:47,340 GIVEN YUKIKO'S TALK AND WHAT WE 1507 01:06:47,340 --> 01:06:54,147 KNOW FROM LIFE, RIGHT, ALL OF US 1508 01:06:54,147 --> 01:06:55,415 ARE VULNERABLE. 1509 01:06:55,415 --> 01:06:57,317 EVERYONE HAS VULNERABILITIES. 1510 01:06:57,317 --> 01:06:58,651 THAT'S NOT HELPFUL PER SE BUT 1511 01:06:58,651 --> 01:07:00,887 IT'S HELPFUL TO THINK ABOUT 1512 01:07:00,887 --> 01:07:04,057 PEOPLE AND WHERE THEY ARE AND IF 1513 01:07:04,057 --> 01:07:05,825 THERE IS A POTENTIAL 1514 01:07:05,825 --> 01:07:07,293 VULNERABILITY IF THERE'S A WAY 1515 01:07:07,293 --> 01:07:10,563 THAT WE CAN ADDRESS IT. 1516 01:07:10,563 --> 01:07:12,198 SO, INDIVIDUALS WHO DON'T 1517 01:07:12,198 --> 01:07:12,766 UNDERSTAND ENGLISH ARE 1518 01:07:12,766 --> 01:07:15,702 VULNERABLE IF THEY'RE HERE IN 1519 01:07:15,702 --> 01:07:17,537 THE UNITED STATES FOR THOSE IN 1520 01:07:17,537 --> 01:07:21,174 SOUTH AMERICA, OBVIOUSLY THE 1521 01:07:21,174 --> 01:07:22,308 REVERSE WOULD BE TRUE. 1522 01:07:22,308 --> 01:07:28,415 BUT WE CAN ADDRESS THIS 1523 01:07:28,415 --> 01:07:28,748 VULNERABILITY. 1524 01:07:28,748 --> 01:07:33,420 WE CAN TRANSLATE S AND HAVE A 1525 01:07:33,420 --> 01:07:35,622 CONSISTENT WAY THAT THOSE WHO 1526 01:07:35,622 --> 01:07:38,992 DON'T SPEAK ENGLISH HAVE ACCESS 1527 01:07:38,992 --> 01:07:41,594 TO SOMEONE WHO CAN PROVIDE THEM 1528 01:07:41,594 --> 01:07:43,930 WITH GUIDANCE AND ANSWER 1529 01:07:43,930 --> 01:07:45,198 QUESTIONS, ETCETERA. 1530 01:07:45,198 --> 01:07:48,068 IF WE PROTECT THE VULNERABLE BY 1531 01:07:48,068 --> 01:07:49,502 EXCLUDING ALL INDIVIDUALS WHO 1532 01:07:49,502 --> 01:07:53,773 ARE UNABLE TO CONSENT, WHAT DO 1533 01:07:53,773 --> 01:07:58,211 WE DO ABOUT ALZHEIMER'S? 1534 01:07:58,211 --> 01:08:02,082 ESPECIALLY LATE STAGE 1535 01:08:02,082 --> 01:08:12,492 ALZHEIMER'S FOR EXAMPLE. 1536 01:08:12,725 --> 01:08:14,861 WE SHOULD ENROLL PEOPLE ONLY WHO 1537 01:08:14,861 --> 01:08:16,729 HAVE EARLY STAGE DEMENTIA 1538 01:08:16,729 --> 01:08:18,798 BECAUSE SOME OF THEM HAVE THE 1539 01:08:18,798 --> 01:08:21,367 CAPACITY TO MAKE A FULLY 1540 01:08:21,367 --> 01:08:23,103 INFORMED DECISION. 1541 01:08:23,103 --> 01:08:25,438 PUT WHAT IF THERE ARE RESEARCH 1542 01:08:25,438 --> 01:08:27,841 QUESTIONS WE NEED TO ASK AMONG 1543 01:08:27,841 --> 01:08:30,243 THOSE WHO HAVE LATER STAGE 1544 01:08:30,243 --> 01:08:31,778 ALZHEIMER'S AND A QUICK ASIDE, I 1545 01:08:31,778 --> 01:08:34,747 DON'T KNOW WE REALLY HAVE A GOOD 1546 01:08:34,747 --> 01:08:37,750 WAY TO DIAGNOSIS EARLY VERSUS 1547 01:08:37,750 --> 01:08:38,084 LATE. 1548 01:08:38,084 --> 01:08:39,786 MAYBE SOME DAY WE'LL HAVE A 1549 01:08:39,786 --> 01:08:41,855 BIOMARKER OR HAVE IDEAS WE'LL 1550 01:08:41,855 --> 01:08:43,423 HAVE A BIOMARKER TO DIAGNOSIS 1551 01:08:43,423 --> 01:08:48,161 THIS, BUT IN SOME CASES THERE'S 1552 01:08:48,161 --> 01:08:49,996 A JUSTIFICATION OR NEEDS TO BE A 1553 01:08:49,996 --> 01:08:51,397 JUSTIFICATION TO ENROLL THOSE 1554 01:08:51,397 --> 01:08:55,468 WHO CAN'T CONSENT ON THEIR OWN. 1555 01:08:55,468 --> 01:08:59,606 AND IN THOSE CASES, WE CAN 1556 01:08:59,606 --> 01:09:04,911 IMAGINE OR IMPLEMENT ADDITIONAL 1557 01:09:04,911 --> 01:09:05,278 SAFEGUARDS. 1558 01:09:05,278 --> 01:09:08,081 FOR EXAMPLE, SAY WE'RE GOING TO 1559 01:09:08,081 --> 01:09:11,151 DESIGN A STUDY OF PATIENTS WHO 1560 01:09:11,151 --> 01:09:12,619 HAVE LATE STAGE ALZHEIMER'S, THE 1561 01:09:12,619 --> 01:09:14,787 WAY RESEARCH WITH THAT GROUP IS 1562 01:09:14,787 --> 01:09:17,590 DONE TODAY IS THAT THERE IS 1563 01:09:17,590 --> 01:09:22,529 SOMEONE WHO SERVES BOTH AS THE 1564 01:09:22,529 --> 01:09:23,029 LEGALLY AUTHORIZED 1565 01:09:23,029 --> 01:09:23,396 REPRESENTATIVE. 1566 01:09:23,396 --> 01:09:25,098 THAT PERSON DESIGNATED AS HAVING 1567 01:09:25,098 --> 01:09:29,969 DECISION MAKING POWER FOR THAT 1568 01:09:29,969 --> 01:09:30,203 PERSON. 1569 01:09:30,203 --> 01:09:32,872 AND A STUDY PARTNER. 1570 01:09:32,872 --> 01:09:36,109 I MAKE THIS DISTINCTION BECAUSE 1571 01:09:36,109 --> 01:09:36,709 LEGALLY AUTHORIZED 1572 01:09:36,709 --> 01:09:37,510 REPRESENTATIVE BASICALLY MEANS 1573 01:09:37,510 --> 01:09:41,214 THERE'S AN ADULT WHO CAN PROVIDE 1574 01:09:41,214 --> 01:09:43,483 CONSENT ON BEHALF OF THIS 1575 01:09:43,483 --> 01:09:44,184 PERSON. 1576 01:09:44,184 --> 01:09:46,319 WHERE STUDY PARTNER REALLY 1577 01:09:46,319 --> 01:09:49,689 IMPLIES THERE'S SOMEONE WHO IS 1578 01:09:49,689 --> 01:09:52,058 GOING TO BE AVAILABLE AND 1579 01:09:52,058 --> 01:09:54,027 HELPING THAT PERSON ENROLL, 1580 01:09:54,027 --> 01:09:55,962 CONTINUE TO BE ENROLLED, GET 1581 01:09:55,962 --> 01:09:57,830 THEM TO THE CLINIC, ASSESS 1582 01:09:57,830 --> 01:09:59,399 WHETHER THIS IS A GOOD OR BAD 1583 01:09:59,399 --> 01:10:02,735 DAY TO TAKE THEM TO THE CLINIC, 1584 01:10:02,735 --> 01:10:03,603 ETCETERA. 1585 01:10:03,603 --> 01:10:05,838 SO THERE'S AN ADDITIONAL 1586 01:10:05,838 --> 01:10:09,075 PROTECTION WHEN THE GROUP OR THE 1587 01:10:09,075 --> 01:10:11,411 INDIVIDUAL IN THAT GROUP IS 1588 01:10:11,411 --> 01:10:12,645 VULNERABLE MAY NOT BE ABLE TO 1589 01:10:12,645 --> 01:10:16,883 PROVIDE THEIR OWN CONCEPT. 1590 01:10:16,883 --> 01:10:20,086 -- CONCEPT. 1591 01:10:20,086 --> 01:10:23,289 -- CONSENT. 1592 01:10:23,289 --> 01:10:25,158 SO NOW WE'RE GOING TO TALK MORE 1593 01:10:25,158 --> 01:10:27,760 BROADLY ABOUT THE PHENOMENON 1594 01:10:27,760 --> 01:10:33,666 YUKIKO MENTIONED THE SHIFT FROM 1595 01:10:33,666 --> 01:10:41,107 PROTECT 1596 01:10:41,107 --> 01:10:43,109 PROTECTING PARTICIPANTS. 1597 01:10:43,109 --> 01:10:46,346 LOOKING BACK TO THE 1970s THEY 1598 01:10:46,346 --> 01:10:47,747 WERE CONCERNED WITH PROTECTING 1599 01:10:47,747 --> 01:10:52,685 VULNERABLE POPULATIONS. 1600 01:10:52,685 --> 01:10:57,390 THIS IS IN THE WAKE OF JEWISH 1601 01:10:57,390 --> 01:10:58,958 STUDY AND THE STUDIES SHARED 1602 01:10:58,958 --> 01:11:04,864 WITH US THAT LED US TO SAY, OH, 1603 01:11:04,864 --> 01:11:10,770 MY GOSH, WE REALLY NEED TO 1604 01:11:10,770 --> 01:11:11,904 PROTECT THESE VULNERABLE 1605 01:11:11,904 --> 01:11:14,807 INDIVIDUALS AND YOU CAN'T UNDULY 1606 01:11:14,807 --> 01:11:16,576 TARGET PRISONERS, 1607 01:11:16,576 --> 01:11:17,243 INSTITUTIONALIZED PEOPLE, POOR 1608 01:11:17,243 --> 01:11:21,914 DURB -- LOOKING AT THE HISTORY 1609 01:11:21,914 --> 01:11:24,484 THEY ARE SAID WE HAVE TO BE 1610 01:11:24,484 --> 01:11:26,619 DIRECTIVE WITH EVERYBODY ON WHO 1611 01:11:26,619 --> 01:11:29,155 THROUGH CAN AND CAN'T ENROLL. 1612 01:11:29,155 --> 01:11:32,392 SHIFT 20 PLUS YEARS WE'RE BEYOND 1613 01:11:32,392 --> 01:11:37,363 THE 1990s BUT IT BEGAN IN THE 1614 01:11:37,363 --> 01:11:39,699 '90s WHERE THERE WAS A PUSH TO 1615 01:11:39,699 --> 01:11:41,200 HAVE DISADVANTAGED GROUPS TO 1616 01:11:41,200 --> 01:11:43,469 HAVE ACCESS TO WHAT CAN BE 1617 01:11:43,469 --> 01:11:48,508 LEARNED THROUGH RESEARCH DURING 1618 01:11:48,508 --> 01:11:48,908 RESEARCH. 1619 01:11:48,908 --> 01:11:56,082 AND WE MUST ASSURE ACCESS IN A 1620 01:11:56,082 --> 01:11:57,183 FAIR WAY. 1621 01:11:57,183 --> 01:11:59,519 I'M GOING TO SWITCH GEARS AND 1622 01:11:59,519 --> 01:12:00,453 TALK A LITTLE BIT ABOUT THE FOOD 1623 01:12:00,453 --> 01:12:01,454 AND DRUG ADMINISTRATION AND TALK 1624 01:12:01,454 --> 01:12:04,424 ABOUT THE NATIONAL INSTITUTES OF 1625 01:12:04,424 --> 01:12:04,891 HEALTH. 1626 01:12:04,891 --> 01:12:08,761 THE FOOD AND DRUG ADMINISTRATION 1627 01:12:08,761 --> 01:12:12,065 HAS TWO COMPETING GOALS. 1628 01:12:12,065 --> 01:12:16,602 ONE IS TO ASSURE SAFETY-BACK TO 1629 01:12:16,602 --> 01:12:20,073 A TALK ABOUT A LONG HISTORY OF 1630 01:12:20,073 --> 01:12:21,941 LET'S LOOK AT WHAT HAPPENS 1631 01:12:21,941 --> 01:12:22,175 BEFORE. 1632 01:12:22,175 --> 01:12:26,913 PEOPLE WERE SELLING THINGS 1633 01:12:26,913 --> 01:12:27,146 POISON. 1634 01:12:27,146 --> 01:12:28,614 PEOPLE WERE SELLING THINGS WITH 1635 01:12:28,614 --> 01:12:29,749 COCAINE WE HAVE TO ADOPT LAWS 1636 01:12:29,749 --> 01:12:32,118 AND POLICY TO PREVENT THOSE BAD 1637 01:12:32,118 --> 01:12:37,857 THINGS FROM HAPPEN. 1638 01:12:37,857 --> 01:12:45,498 THE LAST TWO OWN HERE WERE 1639 01:12:45,498 --> 01:12:47,867 TRIALS THAT LED TO HARM IN 1640 01:12:47,867 --> 01:12:48,134 FETUS. 1641 01:12:48,134 --> 01:12:50,603 PREGNANT WOMEN INGESTED THE 1642 01:12:50,603 --> 01:12:51,571 COMPOUNDS. 1643 01:12:51,571 --> 01:12:59,746 THE HARM WAS TO THEIR INFANTS. 1644 01:12:59,746 --> 01:13:02,081 KNOWN WERE CLINICAL TRIALS. 1645 01:13:02,081 --> 01:13:03,616 THEY'RE LOOKING AT HISTORY AND 1646 01:13:03,616 --> 01:13:06,586 IN NEITHER OF THOSE CASES WAS 1647 01:13:06,586 --> 01:13:08,888 THERE A CLINICAL TRIAL THAT 1648 01:13:08,888 --> 01:13:13,259 DISCOVERED THIS. 1649 01:13:13,259 --> 01:13:15,928 IT WAS THIS COMPOUND NOT YET 1650 01:13:15,928 --> 01:13:23,202 WELL RESTRICTED FOR A LACK OF A 1651 01:13:23,202 --> 01:13:33,746 BETTER THERM AND THALIDOMIDE WAS 1652 01:13:46,426 --> 01:13:48,861 GIVEN AND THIGH THEIR GOAL IS 1653 01:13:48,861 --> 01:13:49,695 ASSURING SAFETY. 1654 01:13:49,695 --> 01:13:52,031 SO IN THE WAKE WITH OF THOSE 1655 01:13:52,031 --> 01:13:53,633 EXAMPLES THE FDA JUST CLOSED THE 1656 01:13:53,633 --> 01:13:55,868 DOOR FOR LACK OF A BETTER TERM, 1657 01:13:55,868 --> 01:14:00,072 FOR THE INCLUSION OF WOMEN IN 1658 01:14:00,072 --> 01:14:00,873 PARTICULAR CLINICAL TRIALS. 1659 01:14:00,873 --> 01:14:04,911 SO IN 1977, THE FDA SAID, AND 1660 01:14:04,911 --> 01:14:07,079 AGAIN THEY'RE MARCHING DOWN THIS 1661 01:14:07,079 --> 01:14:09,081 PATH OF BEING VERY DIRECTIVE 1662 01:14:09,081 --> 01:14:10,550 ABOUT WHO SHOULD BE IN A TRIAL 1663 01:14:10,550 --> 01:14:12,452 AND HOW THE TRIAL SHOULD BE 1664 01:14:12,452 --> 01:14:14,086 DESIGN, WHAT TYPE OF MARKETING 1665 01:14:14,086 --> 01:14:20,092 IS ACCEPTABLE, ETCETERA. 1666 01:14:20,092 --> 01:14:30,670 ONE IS INFANTS ARE AT HIGH RISK 1667 01:14:32,905 --> 01:14:35,107 AN WHEN WE SAY WOMEN, WE SAY 1668 01:14:35,107 --> 01:14:40,813 WOMEN OF CHILDBEARING POTENTIAL. 1669 01:14:40,813 --> 01:14:44,884 AND THAT MEANS THIS 1670 01:14:44,884 --> 01:14:48,688 PREMENOPAUSAL AND CAPABLE OF 1671 01:14:48,688 --> 01:14:51,858 BEING PREGNANT AND WOMEN WHOSE 1672 01:14:51,858 --> 01:15:02,368 HUSBANDS HAVE HAD VASECTOMIES. 1673 01:15:03,269 --> 01:15:05,271 SO LET ME GO TO SLIDO AND OPEN 1674 01:15:05,271 --> 01:15:05,938 THE FIRST QUESTION. 1675 01:15:05,938 --> 01:15:16,482 HOW COULD THE EXCLUSION OF WOMEN 1676 01:15:18,784 --> 01:15:19,452 BE PROBLEMATIC SCIENTIFICALLY? 1677 01:15:19,452 --> 01:15:20,887 YOU CAN FILL IN YOUR ANSWER AND 1678 01:15:20,887 --> 01:15:23,122 THEY'LL APPEAR ON MY SCREEN. 1679 01:15:23,122 --> 01:15:23,756 WE'RE THEN GOING TO TALK ABOUT 1680 01:15:23,756 --> 01:15:33,866 THEM. 1681 01:15:33,866 --> 01:15:35,801 I'M HOPING SOME OF YOU WILL BE 1682 01:15:35,801 --> 01:15:37,537 ABLE TO TYPE IN SOME ANSWERS 1683 01:15:37,537 --> 01:15:37,837 HERE. 1684 01:15:37,837 --> 01:15:40,873 THIS IS THE FIRST TIME WE'RE 1685 01:15:40,873 --> 01:15:44,310 USING SLIDO TODAY. 1686 01:15:44,310 --> 01:15:46,946 WE HAVE NINE PARTICIPANTS 1687 01:15:46,946 --> 01:15:47,179 TYPING. 1688 01:15:47,179 --> 01:15:47,847 THAT'S GOOD. 1689 01:15:47,847 --> 01:15:53,719 HOPING IT WILL COME UP IN A 1690 01:15:53,719 --> 01:15:53,953 SECOND. 1691 01:15:53,953 --> 01:16:01,894 THESE ARE NOT QUESTIONS ABOUT -- 1692 01:16:01,894 --> 01:16:04,096 LOOKS LIKE FOLKS ARE USING IT 1693 01:16:04,096 --> 01:16:04,864 FOR ASKING ME QUESTIONS. 1694 01:16:04,864 --> 01:16:10,937 HERE WE GO. 1695 01:16:10,937 --> 01:16:13,172 SO HERE'S EXAMPLES OF WHAT YOU 1696 01:16:13,172 --> 01:16:15,374 THINK ARE SCIENTIFICALLY 1697 01:16:15,374 --> 01:16:15,708 PROBLEMATIC. 1698 01:16:15,708 --> 01:16:17,643 BIOLOGICAL DIFFERENCES. 1699 01:16:17,643 --> 01:16:22,582 WE HEARD THAT IN YUKIKO'S 1700 01:16:22,582 --> 01:16:22,915 PRESENTATION. 1701 01:16:22,915 --> 01:16:23,649 THERE'S A DISEASE EFFECTS MEN 1702 01:16:23,649 --> 01:16:24,884 AND WOMEN DIFFERENTLY. 1703 01:16:24,884 --> 01:16:25,751 YOU WERE ALL LISTENING. 1704 01:16:25,751 --> 01:16:32,091 I APPRECIATE THAT. 1705 01:16:32,091 --> 01:16:34,627 LEADS TO AN IMBALANCE ON HEALTH 1706 01:16:34,627 --> 01:16:36,862 DISEASES THAT AFFECT WOMEN AND 1707 01:16:36,862 --> 01:16:41,701 MEN OR UNIQUELY WOMEN. 1708 01:16:41,701 --> 01:16:42,602 BIOLOGICAL DIFFERENCES CAN BE 1709 01:16:42,602 --> 01:16:42,969 ASSESSED. 1710 01:16:42,969 --> 01:16:45,271 IT CAN SKEW THE DATA. 1711 01:16:45,271 --> 01:16:48,874 THE RESULTS MIGHT NOT APPLY TO 1712 01:16:48,874 --> 01:16:57,283 WOMEN. 1713 01:16:57,283 --> 01:16:59,151 THERE'S REPRESENTATION AND 1714 01:16:59,151 --> 01:16:59,552 GENERALIZABILITY. 1715 01:16:59,552 --> 01:16:59,752 GREAT. 1716 01:16:59,752 --> 01:17:00,286 THANK YOU ALL FOR THAT. 1717 01:17:00,286 --> 01:17:05,358 LET ME SAY A COUPLE WORDS YES, 1718 01:17:05,358 --> 01:17:06,459 YOU'VE GOT THE RIGHT ANSWERS. 1719 01:17:06,459 --> 01:17:14,066 I WANT TO COME TO THIS ONE ABOUT 1720 01:17:14,066 --> 01:17:14,634 GENERALIZABILITY SOMETHING 1721 01:17:14,634 --> 01:17:19,939 THERE'S A HISTORY OF EXCLUDING 1722 01:17:19,939 --> 01:17:24,076 WOMEN AND YOU'RE AN OB-GYN AND A 1723 01:17:24,076 --> 01:17:26,979 WOMAN COMES IN YOUR OFFICE FOR A 1724 01:17:26,979 --> 01:17:29,415 VISIT AND CURRENTLY TAKING A 1725 01:17:29,415 --> 01:17:32,084 DRUG BECAUSE SHE HAS SEVERE 1726 01:17:32,084 --> 01:17:34,186 EPILEPSY OR ASTHMA OR 1727 01:17:34,186 --> 01:17:34,487 DEPRESSION. 1728 01:17:34,487 --> 01:17:38,391 I'M GOING TO SAY, OH, I'M GOING 1729 01:17:38,391 --> 01:17:42,194 TO LOOK THIS UP AND SAY WHAT THE 1730 01:17:42,194 --> 01:17:42,962 PHYSICIAN'S DRUG REFERENCE SAYS 1731 01:17:42,962 --> 01:17:44,063 ABOUT TREATING WOMEN AND LOOK AT 1732 01:17:44,063 --> 01:17:54,607 THE BOTTLE AND IT SAYS NO WOMEN 1733 01:17:55,241 --> 01:17:56,642 WERE INCLUDED IN CLINICAL TRIALS 1734 01:17:56,642 --> 01:17:58,611 AND YOU'LL HAVE TO MAKE A 1735 01:17:58,611 --> 01:17:59,478 CLINICAL DECISION BASED ON 1736 01:17:59,478 --> 01:18:05,217 RESULTS WE KNOW FROM MEN. 1737 01:18:05,217 --> 01:18:07,486 MEN, WOMEN, HUMAN, ETCETERA. 1738 01:18:07,486 --> 01:18:09,855 IT'S NOT LIKE YOU HAVE NO BUT IT 1739 01:18:09,855 --> 01:18:14,894 MEANS THE RESULT OF THAT 1740 01:18:14,894 --> 01:18:16,162 EXCLUSION SCIENTIFICALLY PUTS 1741 01:18:16,162 --> 01:18:18,464 THE CLINICIAN IN A BAD SPOT 1742 01:18:18,464 --> 01:18:20,666 BECAUSE HE OR SHE CAN'T LOOK AT 1743 01:18:20,666 --> 01:18:23,469 THE LITERATURE AND MAKE A 1744 01:18:23,469 --> 01:18:24,070 THOUGHTFUL CLINICAL DECISION 1745 01:18:24,070 --> 01:18:27,139 ABOUT THE PERSON IN FRONT OF 1746 01:18:27,139 --> 01:18:27,339 THEM. 1747 01:18:27,339 --> 01:18:28,874 AND I'M EXAGGERATING THAT A BIT 1748 01:18:28,874 --> 01:18:29,809 FOR EFFECT BUT IT'S NOT TOO FAR 1749 01:18:29,809 --> 01:18:33,913 OFF. 1750 01:18:33,913 --> 01:18:34,346 OKAY. 1751 01:18:34,346 --> 01:18:37,583 NEXT QUESTION, HOW IS EXCLUSION 1752 01:18:37,583 --> 01:18:42,154 OF WOMEN PROBLEMATIC ETHICALLY? 1753 01:18:42,154 --> 01:18:42,421 GO. 1754 01:18:42,421 --> 01:18:46,659 YOU'RE THE SAME NUMBER AND I 1755 01:18:46,659 --> 01:18:50,229 JUST OPENED THE POLL. 1756 01:18:50,229 --> 01:18:51,564 THIS IS FUN FOR ME IF IT'S NOT 1757 01:18:51,564 --> 01:19:01,774 FUN FOR YOU. 1758 01:19:11,417 --> 01:19:12,885 GOOD, WE HAVE UNFAIR 1759 01:19:12,885 --> 01:19:15,321 DISTRIBUTION. 1760 01:19:15,321 --> 01:19:16,655 GOOD. 1761 01:19:16,655 --> 01:19:19,291 INCLUDED FROM THE POTENTIAL 1762 01:19:19,291 --> 01:19:21,961 BENEFITS AND UNJUST, 1763 01:19:21,961 --> 01:19:22,661 DISCRIMINATORY. 1764 01:19:22,661 --> 01:19:25,998 WE DON'T KNOW HOW TO TREAT 1765 01:19:25,998 --> 01:19:26,198 WOMEN. 1766 01:19:26,198 --> 01:19:27,700 THAT'S SCIENTIFIC AND ETHICAL 1767 01:19:27,700 --> 01:19:28,167 IMPLY CALLINGS. 1768 01:19:28,167 --> 01:19:30,002 IT CAN BLOCK ACCESS TO BENEFITS. 1769 01:19:30,002 --> 01:19:32,071 SO WE'RE TALKING ABOUT THE SHIFT 1770 01:19:32,071 --> 01:19:38,711 IN MIND SET IF BACK IN THE 1970s 1771 01:19:38,711 --> 01:19:42,448 WE EXCLUDED ALL WOMEN NOW WE'RE 1772 01:19:42,448 --> 01:19:44,116 IN 2024 AND KNOW THERE'S 1773 01:19:44,116 --> 01:19:44,884 POTENTIAL BENEFIT WE'RE 1774 01:19:44,884 --> 01:19:50,556 EXCLUDING HER FROM. 1775 01:19:50,556 --> 01:19:53,292 GREAT, YOU'RE ALL COMING IN WITH 1776 01:19:53,292 --> 01:19:55,060 GREAT QUESTIONS AND MISSED 1777 01:19:55,060 --> 01:19:55,361 OPPORTUNITY. 1778 01:19:55,361 --> 01:19:56,428 INTERESTING THE PRODUCT OF 1779 01:19:56,428 --> 01:19:58,664 GESTATION IS A NEW INDIVIDUAL. 1780 01:19:58,664 --> 01:19:59,632 WE COULD TALK ABOUT THAT. 1781 01:19:59,632 --> 01:20:06,539 SO AGAIN, I DON'T WANT TO 1782 01:20:06,539 --> 01:20:13,813 DIMINISH THE HARM THAT AN 1783 01:20:13,813 --> 01:20:16,882 UNIMPORTANT FETUS DIMINISH THE 1784 01:20:16,882 --> 01:20:20,119 HARM A FETUS MAY BE EXPOSED TO 1785 01:20:20,119 --> 01:20:23,923 BUT MY READ OF THAT POLICY WAS 1786 01:20:23,923 --> 01:20:26,826 SOMETHING LIKE THE FOLLOWING, WE 1787 01:20:26,826 --> 01:20:32,131 DON'T TRUST WOMEN TO BE GOOD 1788 01:20:32,131 --> 01:20:32,765 STEWARDS OF THEIR REPRODUCTIVE 1789 01:20:32,765 --> 01:20:37,436 POTENTIAL. 1790 01:20:37,436 --> 01:20:38,904 LIKE WE DON'T TRUST YOU. 1791 01:20:38,904 --> 01:20:41,674 YOU CAN TELL US YOUR SINGLE OR 1792 01:20:41,674 --> 01:20:43,542 TELLING US YOU USE CONTRACEPTION 1793 01:20:43,542 --> 01:20:46,645 OR YOUR PARTNER IS A WOMAN OR A 1794 01:20:46,645 --> 01:20:48,881 MAN THAT HAS HAD A VASECTOMY. 1795 01:20:48,881 --> 01:20:49,715 WE DON'T CARE. 1796 01:20:49,715 --> 01:20:50,883 WE'RE GOING TO CLOSE THE DOOR. 1797 01:20:50,883 --> 01:20:53,652 WE DON'T THINK YOU CAN MAKE A 1798 01:20:53,652 --> 01:20:54,553 THOUGHTFUL DECISION. 1799 01:20:54,553 --> 01:20:57,957 I WOULD SWITCH AND SAY SOMETHING 1800 01:20:57,957 --> 01:20:59,892 LIKE THE FOLLOWING, ONE OF THE 1801 01:20:59,892 --> 01:21:01,627 REASONS WHY WE MIGHT WANT TO 1802 01:21:01,627 --> 01:21:07,666 PROTECT AND I'LL PUT THAT IN AIR 1803 01:21:07,666 --> 01:21:09,101 QUOTES, PREGNANT WOMEN IS FOR 1804 01:21:09,101 --> 01:21:10,936 THE FOLLOWING DIFFERENT REASON. 1805 01:21:10,936 --> 01:21:13,038 PREGNANT WOMEN AS A GROUP, I'M 1806 01:21:13,038 --> 01:21:14,640 SURE YOU'VE MET SOME IN YOUR 1807 01:21:14,640 --> 01:21:19,478 TIME, WILL LIKELY DO ANYTHING 1808 01:21:19,478 --> 01:21:28,487 FOR THE BENEFIT OF THEIR FETUS. 1809 01:21:28,487 --> 01:21:31,090 SO THEY MAY DIMINISH THE RISK OF 1810 01:21:31,090 --> 01:21:32,691 THEMSELVES AND TAKE ON MORE RISK 1811 01:21:32,691 --> 01:21:33,993 OTHERWISE BECAUSE THEY WANT TO 1812 01:21:33,993 --> 01:21:39,031 PROTECT THEIR FETUS. 1813 01:21:39,031 --> 01:21:43,168 SO IN WE REFRAME IT AND SAY WE 1814 01:21:43,168 --> 01:21:44,970 HAVE TO BE CAREFUL IN DOING 1815 01:21:44,970 --> 01:21:46,739 RESEARCH WITH PREGNANT WOMEN 1816 01:21:46,739 --> 01:21:48,073 ONLY OR WITH EVERYONE AND SOME 1817 01:21:48,073 --> 01:21:52,711 FOLKS MAY BE PREGNANT OR BECOME 1818 01:21:52,711 --> 01:21:56,315 PREGNANT, THERE ARE DIFFERENT 1819 01:21:56,315 --> 01:21:58,918 WAYS TO THINK ABOUT 1820 01:21:58,918 --> 01:21:59,285 VULNERABILITY. 1821 01:21:59,285 --> 01:22:01,387 THANK YOU FOR PLAYING AND YOU'LL 1822 01:22:01,387 --> 01:22:03,222 HAVE ANOTHER CHANCE TO USE SLIDO 1823 01:22:03,222 --> 01:22:04,523 WITH DR. LANGFORD'S TALK. 1824 01:22:04,523 --> 01:22:12,898 SO WE'LL CONTINUE ON HERE. 1825 01:22:12,898 --> 01:22:15,634 SO NOW I WANT TO TELL YOU ABOUT 1826 01:22:15,634 --> 01:22:20,506 THE OTHER GOAL OF FDA, ASSURING 1827 01:22:20,806 --> 01:22:20,973 ACCESS. 1828 01:22:20,973 --> 01:22:23,809 THEY HAVE TO PROTECT AND ENSURE 1829 01:22:23,809 --> 01:22:24,043 ACCESS. 1830 01:22:24,043 --> 01:22:28,580 THEY HAVE TWO THINGS RUNNING. 1831 01:22:28,580 --> 01:22:30,649 AND OUR PERSPECTIVE -- I'M USING 1832 01:22:30,649 --> 01:22:34,153 OUR IN THE SENSE OF SCIENTIST, 1833 01:22:34,153 --> 01:22:35,688 POLITICIANS, MEMBERS OF THE 1834 01:22:35,688 --> 01:22:43,162 U.S., CITIZENS HAVE SHIFTED FOR 1835 01:22:43,162 --> 01:22:45,230 THREE REASONS BACK IN THE 1980s 1836 01:22:45,230 --> 01:22:47,433 AND '90s. 1837 01:22:47,433 --> 01:22:48,867 I'M SURE MANY WEREN'T ALIVE, I 1838 01:22:48,867 --> 01:22:55,240 WAS. 1839 01:22:55,240 --> 01:23:02,514 WHEN THERE WAS NO TREATMENT FOR 1840 01:23:02,514 --> 01:23:04,850 HIV, MANY PEOPLE WERE DYING OF 1841 01:23:04,850 --> 01:23:05,384 AIDS. 1842 01:23:05,384 --> 01:23:08,087 HIV IS THE VIRUS, AIDS ARE THE 1843 01:23:08,087 --> 01:23:08,887 OPPORTUNISTIC INFECTION AND 1844 01:23:08,887 --> 01:23:12,224 CANCERS AND OTHER DISEASES THAT 1845 01:23:12,224 --> 01:23:13,859 ATTACK INDIVIDUALS WITH HIV 1846 01:23:13,859 --> 01:23:18,964 BECAUSE THEIR IMMUNE SYSTEM IS 1847 01:23:18,964 --> 01:23:24,336 SEVERELY COMPROMISED. 1848 01:23:24,336 --> 01:23:27,606 SO AIDS ACTIVISTS STARTED 1849 01:23:27,606 --> 01:23:29,241 PROTESTING HERE AT TO THE NIH 1850 01:23:29,241 --> 01:23:30,876 AND THIS PICTURE IS FROM THE FDA 1851 01:23:30,876 --> 01:23:33,278 AND AIDS ACTIVISTS WERE INVITED 1852 01:23:33,278 --> 01:23:38,817 TO THE TABLE AT THE NIH ALSO AT 1853 01:23:38,817 --> 01:23:42,821 THE FDA AND THEY MADE THEIR 1854 01:23:42,821 --> 01:23:43,756 INTERESTS KNOWN SAYING SOMETHING 1855 01:23:43,756 --> 01:23:47,059 LIKE THE FOLLOWING, LOOK, YOU 1856 01:23:47,059 --> 01:23:48,861 DON'T UNDERSTAND, WE HAVE NO 1857 01:23:48,861 --> 01:23:49,828 TREATMENT OPTIONS. 1858 01:23:49,828 --> 01:23:52,631 YOU'VE GOT TO GET THESE DRUGS 1859 01:23:52,631 --> 01:24:00,072 OUT THERE AND IN US ASAP. 1860 01:24:00,072 --> 01:24:01,940 WE DIDN'T ALLOW INDIVIDUAL TO 1861 01:24:01,940 --> 01:24:07,946 TAKE ON CRIAZY LEVEL OF RISK. 1862 01:24:07,946 --> 01:24:10,115 WE STILL SENT TRIALS THROUGH 1863 01:24:10,115 --> 01:24:11,683 SYSTEMATIC AND IRB REVIEW BUT 1864 01:24:11,683 --> 01:24:12,951 THERE WAS MOVEMENT TOWARDS 1865 01:24:12,951 --> 01:24:14,820 ACCESS TO CLINICAL TRIALS. 1866 01:24:14,820 --> 01:24:16,321 THE TERM I THINK IT'S NOT ON 1867 01:24:16,321 --> 01:24:18,557 HERE BUT SOME OF THE PROTEST 1868 01:24:18,557 --> 01:24:20,859 SIGNS SAY ACCESS TO CLINICAL 1869 01:24:20,859 --> 01:24:24,863 TRIALS IS ACCESS TO HEALTH CARE. 1870 01:24:24,863 --> 01:24:27,166 NOW, THAT'S A WHOLE OTHER 1871 01:24:27,166 --> 01:24:28,267 CONVERSATION WE COULD HAVE BUT 1872 01:24:28,267 --> 01:24:30,803 THE IDEA IS WE HAVE NO OPTIONS. 1873 01:24:30,803 --> 01:24:35,908 YOU HAVE TO GET THE CLINICAL 1874 01:24:35,908 --> 01:24:37,910 TRIALS UP AND RUNNING AND ONE 1875 01:24:37,910 --> 01:24:42,214 POLICY RESPONSE IS AIDS ACTIVISM 1876 01:24:42,214 --> 01:24:48,187 WAS PARALLEL TRACT BACK IN 1989 1877 01:24:48,187 --> 01:24:51,123 WHERE YOU HAVE ONE TRAIN GOING 1878 01:24:51,123 --> 01:24:53,459 THROUGH THE REGULAR PHASE I, II 1879 01:24:53,459 --> 01:24:55,594 AND III TRACK AND THE PARALLEL 1880 01:24:55,594 --> 01:24:57,563 TRACT IS LET'S EXPAND ACCESS TO 1881 01:24:57,563 --> 01:25:02,000 PEOPLE WHO HAVE HIV WHO WERE 1882 01:25:02,000 --> 01:25:04,870 UNABLE TOE ENROLL IN ANY OF THE 1883 01:25:04,870 --> 01:25:15,114 TRIALS ON THE MAIN TRACT. 1884 01:25:15,114 --> 01:25:15,747 THEY LIVE FAR AWAY. 1885 01:25:15,747 --> 01:25:21,787 THERE WAS AN INITIATIVE TO ALLOW 1886 01:25:21,787 --> 01:25:30,696 INDIVIDUALS TO EXPERIMENT AL 1887 01:25:30,696 --> 01:25:32,097 TRACK AND THERE WERE 1888 01:25:32,097 --> 01:25:35,834 EXPECTATIONS ABOUT GATHERING 1889 01:25:35,834 --> 01:25:36,401 DATA. 1890 01:25:36,401 --> 01:25:37,336 YOU HAD TO HAVE A CLINICIAN 1891 01:25:37,336 --> 01:25:40,873 WILLING TO MONITOR YOU AND IT 1892 01:25:40,873 --> 01:25:44,376 WASN'T A FREE-FOR-ALL BUT A 1893 01:25:44,376 --> 01:25:46,378 DIRECT RESPONSE TO YOU HAVE TO 1894 01:25:46,378 --> 01:25:50,115 GET THIS TO US SOON. 1895 01:25:50,115 --> 01:25:51,783 AND INDIVIDUALS DOING 1896 01:25:51,783 --> 01:25:54,319 METAANALYSIS SAID HEY, LO AND 1897 01:25:54,319 --> 01:25:56,855 BEHOLD WE WERE WORRIED ABOUT THE 1898 01:25:56,855 --> 01:25:59,124 RISKY RESEARCH AND HARM THAT MAY 1899 01:25:59,124 --> 01:26:00,392 COME TO INDIVIDUALS. 1900 01:26:00,392 --> 01:26:02,161 IT TURNS OUT THE ACTUAL LEVEL OF 1901 01:26:02,161 --> 01:26:04,863 HARM TO THOSE ENROLLED IS REALLY 1902 01:26:04,863 --> 01:26:05,998 NOT THAT HIGH. 1903 01:26:05,998 --> 01:26:08,100 SO THAT INCENTIVE TO KEEP PEOPLE 1904 01:26:08,100 --> 01:26:11,236 OUT TO PROTECT THEM FROM HARM 1905 01:26:11,236 --> 01:26:14,640 WAS LESSENED FROM A BIO 1906 01:26:14,640 --> 01:26:16,542 STATISTICAL PERSPECTIVE. 1907 01:26:16,542 --> 01:26:20,879 AND FINALLY, THE PICTURE I LOVE 1908 01:26:20,879 --> 01:26:25,217 THE CONGRESSIONAL WOMEN'S CAUCUS 1909 01:26:25,217 --> 01:26:26,585 BEGAN AN INTEREST IN THE 1910 01:26:26,585 --> 01:26:27,519 EXCLUSION OF WOMEN IN CLINICAL 1911 01:26:27,519 --> 01:26:27,786 TRIALS. 1912 01:26:27,786 --> 01:26:30,088 WHY IS THIS THE CASE? 1913 01:26:30,088 --> 01:26:32,891 THIS WAS AT THIS TIME WAS SORT 1914 01:26:32,891 --> 01:26:35,027 OF THE HIGH POINT IN THE NUMBER 1915 01:26:35,027 --> 01:26:39,498 OF WOMEN WHO WERE IN CONGRESS. 1916 01:26:39,498 --> 01:26:45,070 THIS WAS LIKE A TON COMPARED TO 1917 01:26:45,070 --> 01:26:50,142 WHAT WAS USUAL. 1918 01:26:50,142 --> 01:26:53,545 THEY WERE A BIG ENOUGH BODY TO 1919 01:26:53,545 --> 01:26:54,580 HAVE SOME WAY AND TALK BRIEFLY 1920 01:26:54,580 --> 01:26:59,051 TO GIVE YOU A BIT OF THE POLICY 1921 01:26:59,051 --> 01:27:01,520 ENVIRONMENT IN WHICH 1922 01:27:01,520 --> 01:27:03,589 INVESTIGATORS ARE NAVIGATING, 1923 01:27:03,589 --> 01:27:05,290 QUOTE, UNQUOTE, THE FUNDING THEY 1924 01:27:05,290 --> 01:27:08,126 AND WHO THEY HAVE TO THINK ABOUT 1925 01:27:08,126 --> 01:27:12,931 IN TERMS OF INCLUDING. 1926 01:27:12,931 --> 01:27:14,566 THAT'S IN THEIR RESEARCH. 1927 01:27:14,566 --> 01:27:16,368 SO YUKIKO TALKED ABOUT THE 1928 01:27:16,368 --> 01:27:18,070 SCIENTIFIC REASONS WHY YOU 1929 01:27:18,070 --> 01:27:20,606 SHOULD THINK ABOUT BIOLOGY, 1930 01:27:20,606 --> 01:27:25,944 INCLUSION, CAN'T REMEMBER HER 1931 01:27:25,944 --> 01:27:28,213 THIRD, SOCIAL CONCERNS. 1932 01:27:28,213 --> 01:27:31,717 IN ORDER TO ENFORCE SOME OF THE 1933 01:27:31,717 --> 01:27:34,052 THINGS THAT CONGRESS THAT OTHERS 1934 01:27:34,052 --> 01:27:36,888 THOUGHT OUGHT TO BE IN PLACE, 1935 01:27:36,888 --> 01:27:41,226 CONGRESS TOLD THE NIH, TOLD THE 1936 01:27:41,226 --> 01:27:44,062 FDA TO START PASSING, 1937 01:27:44,062 --> 01:27:45,931 IMPLEMENTING POLICIES THAT WOULD 1938 01:27:45,931 --> 01:27:49,201 QUOTE, UNQUOTE ENFORCE A SOCIAL 1939 01:27:49,201 --> 01:27:50,135 NORM. 1940 01:27:50,135 --> 01:27:50,335 RIGHT? 1941 01:27:50,335 --> 01:27:54,172 WE ALL -- LET'S ALL PRETEND THAT 1942 01:27:54,172 --> 01:27:55,307 WE THINK WOMEN SHOULD BE 1943 01:27:55,307 --> 01:27:55,941 INCLUDED IN RESEARCH. 1944 01:27:55,941 --> 01:27:57,409 LET'S MAKE THAT HAPPEN BY 1945 01:27:57,409 --> 01:27:58,243 PUTTING IT INTO LAW IN TERMS OF 1946 01:27:58,243 --> 01:28:03,682 GUIDANCE. 1947 01:28:03,682 --> 01:28:10,222 ONE POINT WITH THE SLIDE, NIH IS 1948 01:28:10,222 --> 01:28:14,793 RESPONSIBLE FOR A LOT OF FUNDING 1949 01:28:14,793 --> 01:28:16,228 IN THE EXTRAMURAL COMMUNITY. 1950 01:28:16,228 --> 01:28:17,596 WE'RE PHYSICALLY HERE IN THE 1951 01:28:17,596 --> 01:28:20,465 CLINICAL CENTER WHICH IS PART OF 1952 01:28:20,465 --> 01:28:22,668 THE INTRAMURAL RESEARCH PROGRAM. 1953 01:28:22,668 --> 01:28:25,604 ABOUT 10% OF NIH FUNDING COMES 1954 01:28:25,604 --> 01:28:27,839 HERE AND THERE'S 6,000 1955 01:28:27,839 --> 01:28:28,907 INVESTIGATORS AROUND THIS AREA 1956 01:28:28,907 --> 01:28:32,311 DOING RESEARCH. 1957 01:28:32,311 --> 01:28:36,915 BUT 84% OF $48 BILLION GOES OUT 1958 01:28:36,915 --> 01:28:39,384 IN THE EXTRAMURAL WORLD. 1959 01:28:39,384 --> 01:28:43,221 SO IN 2023, 50,000 COMPETITIVE 1960 01:28:43,221 --> 01:28:46,191 GRANTS TO MORE THAN 3,000 1961 01:28:46,191 --> 01:28:48,894 RESEARCHERS, RIGHT. 1962 01:28:48,894 --> 01:28:52,030 SO NIH HAS A BIG SWAY IN HOW 1963 01:28:52,030 --> 01:28:53,565 RESEARCH IS DONE BECAUSE THEY 1964 01:28:53,565 --> 01:28:59,705 ARE FUNDING A TON OF RESEARCH. 1965 01:28:59,705 --> 01:29:02,140 NOW, YOU MIGHT ASK WHAT ABOUT 1966 01:29:02,140 --> 01:29:02,774 PHARMA? 1967 01:29:02,774 --> 01:29:08,814 HOW DO WE THINK ABOUT PHARMA AND 1968 01:29:08,814 --> 01:29:12,084 HOW THEY'RE DOING? 1969 01:29:12,084 --> 01:29:15,520 LET'S SET ASIDE SOME NIH FUNDING 1970 01:29:15,520 --> 01:29:16,321 RESEARCH BECOMES A PRODUCT 1971 01:29:16,321 --> 01:29:20,859 PHARMACEUTICAL COMPANIES ADOPT 1972 01:29:20,859 --> 01:29:26,131 AND THEN MARKET. 1973 01:29:26,131 --> 01:29:27,966 IN ORDER TO GET YOUR DRUG 1974 01:29:27,966 --> 01:29:30,268 APPROVED YOU HAVE TO FOLLOW THE 1975 01:29:30,268 --> 01:29:32,037 RULES FDA TELLS YOU TO FOLLOW. 1976 01:29:32,037 --> 01:29:33,305 WHEN WE THINK OF THE CLINICAL 1977 01:29:33,305 --> 01:29:34,539 RESEARCH THAT HAPPENS IN THE 1978 01:29:34,539 --> 01:29:35,841 UNITED STATES AND THAT'S MY VIEW 1979 01:29:35,841 --> 01:29:38,143 SO SORRY FOR THOSE NOT FROM THE 1980 01:29:38,143 --> 01:29:41,713 U.S. IN OUR AUDIENCE, THE NIH 1981 01:29:41,713 --> 01:29:44,783 AND FDA HAVE A HUGE AMOUNT OF 1982 01:29:44,783 --> 01:29:46,418 POWER IN TELLING INVESTIGATORS 1983 01:29:46,418 --> 01:29:49,788 WHAT TO DO OR WHAT NOT TO DO. 1984 01:29:49,788 --> 01:29:51,723 SO, I JUST WANT TO -- I'M NOT 1985 01:29:51,723 --> 01:29:53,258 GOING TO GO THROUGH ALL THESE 1986 01:29:53,258 --> 01:29:53,658 POLICIES. 1987 01:29:53,658 --> 01:29:54,926 I JUST WANT YOU TO PAY ATTENTION 1988 01:29:54,926 --> 01:30:00,899 TO SOME OF THE WORDS I'VE 1989 01:30:00,899 --> 01:30:01,466 HIGHLIGHTED. 1990 01:30:01,466 --> 01:30:04,669 OVER THE LAST 40 YEARS THE NIH 1991 01:30:04,669 --> 01:30:07,005 HAS IMPLEMENTED A NUMBER OF 1992 01:30:07,005 --> 01:30:10,475 POLICIES THAT TELL RESEARCHERS 1993 01:30:10,475 --> 01:30:14,479 THEY MUST INCLUDE WOMEN, 1994 01:30:14,479 --> 01:30:16,481 MINORITIES, CHILDREN AND THEN WE 1995 01:30:16,481 --> 01:30:19,384 DECIDED RELATIVELY RECENTLY WE 1996 01:30:19,384 --> 01:30:20,552 SHOULD BE THINKING ABOUT 1997 01:30:20,552 --> 01:30:21,386 CHILDREN AND SHOULD THINK ABOUT 1998 01:30:21,386 --> 01:30:22,687 OLDER ADULTS. 1999 01:30:22,687 --> 01:30:25,957 SO KIDS AND OLDER ADULTS ARE NOW 2000 01:30:25,957 --> 01:30:27,459 IN THIS POLICY CALLED INCLUSION 2001 01:30:27,459 --> 01:30:28,059 OF INDIVIDUALS CROSS THE LIFE 2002 01:30:28,059 --> 01:30:33,398 SPAN. 2003 01:30:33,398 --> 01:30:35,567 THAT MEANS IF YOU'RE AN 2004 01:30:35,567 --> 01:30:36,701 INVESTIGATOR YOU HAVE TO KEEP 2005 01:30:36,701 --> 01:30:38,937 TRACK OF ALL THE POLICIES AND 2006 01:30:38,937 --> 01:30:40,605 HOW THEY INFLUENCE THE 2007 01:30:40,605 --> 01:30:41,640 SCIENTIFIC DECISIONS YOU'RE 2008 01:30:41,640 --> 01:30:43,008 MAKING ABOUT YOUR WORK. 2009 01:30:43,008 --> 01:30:46,945 AND I WANT TO TOUCH ON TWO OTHER 2010 01:30:46,945 --> 01:30:48,847 POPULATIONS THAT YUKIKO 2011 01:30:48,847 --> 01:30:49,114 MENTIONED. 2012 01:30:49,114 --> 01:30:51,783 THE FIRST IS THOSE WITH 2013 01:30:51,783 --> 01:30:52,117 DISABILITIES. 2014 01:30:52,117 --> 01:30:56,154 NOW, THE NATIONAL KANSAS ON 2015 01:30:56,154 --> 01:30:59,157 DISABILITIES RECENTLY PUT OUT A 2016 01:30:59,157 --> 01:31:01,960 REPORT CALLING OUT THE EXCLUSION 2017 01:31:01,960 --> 01:31:03,328 OF PEOPLE WITH DISABILITY IN 2018 01:31:03,328 --> 01:31:06,698 CLINICAL TRIALS. 2019 01:31:06,698 --> 01:31:10,569 AND THEY HAVE SOME 2020 01:31:10,569 --> 01:31:11,636 RECOMMENDATIONS FOR THE HHS AND 2021 01:31:11,636 --> 01:31:13,271 FDA AND NIH AND THEY'RE BOTH 2022 01:31:13,271 --> 01:31:21,646 PARTS OF HHS. 2023 01:31:21,646 --> 01:31:23,048 AGAIN, THESE ARE THE SAME 2024 01:31:23,048 --> 01:31:26,151 REASONS WHY THERE WERE EFFORTS 2025 01:31:26,151 --> 01:31:32,324 TO INCLUDE WOMEN AND CHILDREN. 2026 01:31:32,324 --> 01:31:36,895 WE HAVE TO AVOID UNNECESSARY 2027 01:31:36,895 --> 01:31:38,296 INCLUSION RECOMMEND ALL 2028 01:31:38,296 --> 01:31:40,165 INCLUSION CRITERIA BY 2029 01:31:40,165 --> 01:31:40,699 SCIENTIFICALLY JUSTIFIED. 2030 01:31:40,699 --> 01:31:41,967 VERY SIMILAR THEMES. 2031 01:31:41,967 --> 01:31:44,970 AND THE NIH HAS COME OUT WITH A 2032 01:31:44,970 --> 01:31:48,573 POLICY IT'S NOT YET AT THE LEVEL 2033 01:31:48,573 --> 01:31:49,841 OF GUIDELINE THAT SAYS 2034 01:31:49,841 --> 01:31:51,209 INVESTIGATORS, YOU OUGHT TO HAVE 2035 01:31:51,209 --> 01:31:52,444 THIS ON YOUR PLATE IN ADDITION 2036 01:31:52,444 --> 01:31:53,545 TO OTHER THINGS YOU SHOULD BE 2037 01:31:53,545 --> 01:31:58,250 THINKING ABOUT THIS AS WELL. 2038 01:31:58,250 --> 01:32:00,285 THE OTHER GROUP IS SEX AND 2039 01:32:00,285 --> 01:32:01,186 GENDER MINORITIES. 2040 01:32:01,186 --> 01:32:02,487 SO THE SECRETARY'S ADVISORY 2041 01:32:02,487 --> 01:32:04,890 COMMITTEE ON HUMAN RESEARCH 2042 01:32:04,890 --> 01:32:07,993 PROTECTIONS I'LL JUST TELL YOU 2043 01:32:07,993 --> 01:32:09,094 IT'S AN IMPORTANT ADVISORY GROUP 2044 01:32:09,094 --> 01:32:12,264 ON ISSUES RELATED TO CLINICAL 2045 01:32:12,264 --> 01:32:12,531 RESEARCH. 2046 01:32:12,531 --> 01:32:16,735 THEY JUST CAME OUT WITH A POLICY 2047 01:32:16,735 --> 01:32:17,702 AND CONSIDERATIONS DIRECTED TO 2048 01:32:17,702 --> 01:32:20,138 THE SECRETARY OF HEALTH AND 2049 01:32:20,138 --> 01:32:23,808 HUMAN SERVICES FOR ALL 2050 01:32:23,808 --> 01:32:24,509 INVESTIGATORS TO THINK ABOUT 2051 01:32:24,509 --> 01:32:25,677 ANOTHER SET OF CONSIDERATIONS 2052 01:32:25,677 --> 01:32:31,283 FOR THE DESIGN, REVIEW AND 2053 01:32:31,283 --> 01:32:39,057 CONDUCT OF AND RESEARCH WITH 2054 01:32:39,057 --> 01:32:40,892 THOSE WHO ARE SEX AND GENDER 2055 01:32:40,892 --> 01:32:41,192 MINORITIES. 2056 01:32:41,192 --> 01:32:48,533 AND I MENTION THIS IN THE SENSE 2057 01:32:48,533 --> 01:32:49,801 OF INCREMENTAL PROGRESS WITH THE 2058 01:32:49,801 --> 01:32:50,135 TOPICS. 2059 01:32:50,135 --> 01:32:52,904 I DON'T KNOW WHERE IT WILL GO 2060 01:32:52,904 --> 01:32:56,541 NEXT. 2061 01:32:56,541 --> 01:32:58,510 IT ALSO PUTS INVESTIGATORS IN 2062 01:32:58,510 --> 01:33:01,413 THE POSITION OF HAVING TO 2063 01:33:01,413 --> 01:33:04,583 NAVIGATE A LOT OF WHEN THINKING 2064 01:33:04,583 --> 01:33:06,718 ABOUT APPLYING TO THE NIH. 2065 01:33:06,718 --> 01:33:08,186 NOW I'LL TELL YOU A SIMILAR 2066 01:33:08,186 --> 01:33:18,363 STORY FROM FRAD. 2067 01:33:18,363 --> 01:33:19,898 -- FROM NIH. 2068 01:33:19,898 --> 01:33:20,899 FIRST THING THEY DID WAS 2069 01:33:20,899 --> 01:33:23,635 WITHDRAW THE POLICY I MENTIONED 2070 01:33:23,635 --> 01:33:25,503 ABOUT EXCLUDING WOMEN BUT IT 2071 01:33:25,503 --> 01:33:27,505 WASN'T WITHDRAWN UNTIL 1993. 2072 01:33:27,505 --> 01:33:28,907 AGAIN SOME WERE BORN AFTER THAT 2073 01:33:28,907 --> 01:33:29,708 BUT THAT'S IN MY LIFE TIME 2074 01:33:29,708 --> 01:33:38,950 CERTAINLY. 2075 01:33:38,950 --> 01:33:40,585 YOU CAN SEE INCREMENTAL CHANGES 2076 01:33:40,585 --> 01:33:46,024 FDA IS MAKING IN GUIDELINES 2077 01:33:46,024 --> 01:33:48,693 DIRECTED AT PHARMACEUTICAL 2078 01:33:48,693 --> 01:33:50,862 COMPANIES BECAUSE THAT'S THEIR 2079 01:33:50,862 --> 01:33:51,196 CONSTITUENCY. 2080 01:33:51,196 --> 01:33:55,400 NOW IMAGINE YOU'RE AN 2081 01:33:55,400 --> 01:33:56,835 INVESTIGATOR WHO IS FUNDED BY 2082 01:33:56,835 --> 01:33:59,437 THE NIH AND PLANNING TO PURSUE 2083 01:33:59,437 --> 01:33:59,704 MARKETING. 2084 01:33:59,704 --> 01:34:01,439 THERE'S A WHOLE LOT TO KEEP 2085 01:34:01,439 --> 01:34:01,806 TRACK OF. 2086 01:34:01,806 --> 01:34:08,580 BUT AGAIN THE IDEA HERE IS THAT 2087 01:34:08,580 --> 01:34:16,521 WAVE ALL AGREED THERE'S A 2088 01:34:16,521 --> 01:34:18,657 DIVERSE POPULATIONS IN SAMPLES 2089 01:34:18,657 --> 01:34:26,965 WE USE FOR CLINICAL RESEARCH. 2090 01:34:26,965 --> 01:34:28,266 AGAIN A WHOLE LONG LIST YOU'LL 2091 01:34:28,266 --> 01:34:30,001 HAVE IN THE SLIDES IF YOU'RE 2092 01:34:30,001 --> 01:34:31,369 INTERESTED. 2093 01:34:31,369 --> 01:34:35,507 RELATIVELY RECENTLY THE FDA PUT 2094 01:34:35,507 --> 01:34:37,175 OUT THIS DOCUMENT CALLED 2095 01:34:37,175 --> 01:34:39,344 ENHANCING THE DIVERSITY OF 2096 01:34:39,344 --> 01:34:41,646 CLINICAL TRIAL POPULATIONS. 2097 01:34:41,646 --> 01:34:43,882 ELIGIBILITY CRITERIA, ENROLLMENT 2098 01:34:43,882 --> 01:34:52,090 PRACTICE AND GUIDANCE FOR 2099 01:34:52,090 --> 01:34:59,631 INDUSTRY. 2100 01:34:59,631 --> 01:35:00,832 ATTENTION TO SEX AND GENDER 2101 01:35:00,832 --> 01:35:05,737 MINORITIES AND THE NEW DRAFT 2102 01:35:05,737 --> 01:35:16,247 CAME OUT IN SEPTEMBER AND WE 2103 01:35:23,621 --> 01:35:25,323 HAVE THE THEMES NIH HAS BEEN 2104 01:35:25,323 --> 01:35:28,493 TALKING ABOUT AND FDA IS ALSO 2105 01:35:28,493 --> 01:35:32,163 TALKING ABOUT GENDER IDENTITY, 2106 01:35:32,163 --> 01:35:33,531 SEXUAL ORIENTATION AND PHYSICAL 2107 01:35:33,531 --> 01:35:35,934 AND MENTAL DISABILITIES SO 2108 01:35:35,934 --> 01:35:36,668 PILING IT ON. 2109 01:35:36,668 --> 01:35:38,770 ANOTHER QUICK ASIDE IS THERE ARE 2110 01:35:38,770 --> 01:35:41,773 LOTS OF PLAYERS IN THIS POLICY 2111 01:35:41,773 --> 01:35:42,707 DEBATE. 2112 01:35:42,707 --> 01:35:48,313 SO THE NATIONAL ACADEMY OF 2113 01:35:48,313 --> 01:35:50,148 SCIENCES HAS A WHOLE SET OF 2114 01:35:50,148 --> 01:35:52,417 BOOKS ABOUT THIS. 2115 01:35:52,417 --> 01:35:53,251 THE GOVERNMENT ACCOUNTING 2116 01:35:53,251 --> 01:35:55,620 OFFICE, THEY'RE THE ONES WHO DID 2117 01:35:55,620 --> 01:35:57,689 THE TALLYING UP OF HOW WE'RE 2118 01:35:57,689 --> 01:35:59,991 DOING ON THE POLICIES. 2119 01:35:59,991 --> 01:36:01,459 THE BOTTOM LINE IS WE'VE BEEN 2120 01:36:01,459 --> 01:36:05,230 THINKING ABOUT THIS SINCE THE 2121 01:36:05,230 --> 01:36:05,730 1980s. 2122 01:36:05,730 --> 01:36:09,467 WE'RE STILL REALLY FAR FROM 2123 01:36:09,467 --> 01:36:10,969 SAYING, OH, GOSH, IT WORKED. 2124 01:36:10,969 --> 01:36:12,370 ALL THE SAMPLES ARE DIVERSE. 2125 01:36:12,370 --> 01:36:15,173 ALL THE SAMPLES HAVE LOTS OF 2126 01:36:15,173 --> 01:36:16,908 MEMBERS AND MINORITY 2127 01:36:16,908 --> 01:36:17,275 COMMUNITIES. 2128 01:36:17,275 --> 01:36:19,144 IT'S ONE THING TO SAY IT'S A 2129 01:36:19,144 --> 01:36:20,912 SOCIAL NORM AND HERE'S OUR 2130 01:36:20,912 --> 01:36:21,246 POLICY. 2131 01:36:21,246 --> 01:36:23,815 IT'S ANOTHER TO THINK ABOUT WHAT 2132 01:36:23,815 --> 01:36:26,151 THIS MEANS IN PRACTICE AND THAT 2133 01:36:26,151 --> 01:36:28,286 IS WHAT DR. LANGFORD IS GOING TO 2134 01:36:28,286 --> 01:36:30,588 TALK ABOUT IN A COUPLE MINUTES. 2135 01:36:30,588 --> 01:36:33,892 SO, I AM NOW OPEN FOR QUESTIONS 2136 01:36:33,892 --> 01:36:36,060 AND FOR THOSE IN THE ROOM, 2137 01:36:36,060 --> 01:36:38,163 PLEASE HEAD TO THE MICROPHONES 2138 01:36:38,163 --> 01:36:40,098 AND I'M GOING TO OPEN MY 2139 01:36:40,098 --> 01:36:41,766 COMPUTER AND SEE IF THERE ARE 2140 01:36:41,766 --> 01:36:44,169 ANY QUESTIONS OUT IN VIDEO LAND. 2141 01:36:44,169 --> 01:36:46,571 A REMINDER TO THOSE OF YOU WHO 2142 01:36:46,571 --> 01:36:49,574 ARE OUT IN VIDEO LAND, I'M NOT 2143 01:36:49,574 --> 01:36:53,645 LOOKING AT SLIDO FOR QUESTIONS, 2144 01:36:53,645 --> 01:36:55,079 I'M LOOKING AT THE DISCUSSION 2145 01:36:55,079 --> 01:36:59,484 BOARD AND THE EMAIL OR ALEX IS 2146 01:36:59,484 --> 01:37:00,919 FORWARDING THE EMAIL IF HE GETS 2147 01:37:00,919 --> 01:37:02,787 ANY AND LOOK AT THE SLIDO 2148 01:37:02,787 --> 01:37:04,789 QUESTIONS LATER. 2149 01:37:04,789 --> 01:37:04,989 MIRA. 2150 01:37:04,989 --> 01:37:12,530 >> YEAH, SO I WAS CURIOUS ABOUT 2151 01:37:12,530 --> 01:37:14,999 THE SITUATION WITH THE AIDS 2152 01:37:14,999 --> 01:37:16,534 ACTIVISM AND THE RISK 2153 01:37:16,534 --> 01:37:17,836 CALCULATION FOR THE 2154 01:37:17,836 --> 01:37:18,169 PARTICIPANTS. 2155 01:37:18,169 --> 01:37:20,805 SO YOU SAID THAT THEY REVISED 2156 01:37:20,805 --> 01:37:22,440 THEIR INITIAL ASSESSMENT, RIGHT, 2157 01:37:22,440 --> 01:37:26,144 THAT THE RISKS WERE TOO HIGH. 2158 01:37:26,144 --> 01:37:28,880 WHAT FACTORS WENT INTO THAT 2159 01:37:28,880 --> 01:37:31,649 REVISION? 2160 01:37:31,649 --> 01:37:42,160 >> SO, WHAT I WAS SAYING WAS 2161 01:37:49,334 --> 01:37:52,904 LET'S HAVE ACCESS EARLY AND 2162 01:37:52,904 --> 01:37:55,340 ENROLL EARLY. 2163 01:37:55,340 --> 01:37:57,375 THE RESPONSE WAS WE HEAR YOU BUT 2164 01:37:57,375 --> 01:38:00,411 ARE NOT GOING TO SAY IT'S 2165 01:38:00,411 --> 01:38:02,080 PERFECTLY FINE FOR THIS GROUP TO 2166 01:38:02,080 --> 01:38:04,115 MAKE A DECISION TO EXPOSE 2167 01:38:04,115 --> 01:38:07,051 YOURSELF TO A HIGH LEVEL OF RISK 2168 01:38:07,051 --> 01:38:09,220 THAT WE THE SCIENTIFIC COMMUNITY 2169 01:38:09,220 --> 01:38:12,924 DON'T THINK IS SCIENTIFICALLY OR 2170 01:38:12,924 --> 01:38:13,758 ETHICALLY APPROPRIATE. 2171 01:38:13,758 --> 01:38:15,693 A WAY TO SAY THAT IS IT THIS 2172 01:38:15,693 --> 01:38:18,029 WALL OVER HERE OF THIS IS HOW WE 2173 01:38:18,029 --> 01:38:23,701 DO TRIALS, PHASE I, II, III, 2174 01:38:23,701 --> 01:38:25,036 THAT CAN TAKE UP TO 10 YEARS AND 2175 01:38:25,036 --> 01:38:29,173 YOU HAVE A GROUP OF PEOPLE OVER 2176 01:38:29,173 --> 01:38:30,642 HERE DYING OF AIDS. 2177 01:38:30,642 --> 01:38:35,880 THERE WAS PUSH AGAINST THIS WALL 2178 01:38:35,880 --> 01:38:37,081 AND THE RESPONSE WAS WE HEAR YOU 2179 01:38:37,081 --> 01:38:44,989 AND WE'LL CREATE A WAY WITH YOUR 2180 01:38:44,989 --> 01:38:45,323 HE 2181 01:38:45,323 --> 01:38:47,625 HELP AND ALLOW FOR ACCESS 2182 01:38:47,625 --> 01:38:50,194 EARLIER THAN WE USE TO. 2183 01:38:50,194 --> 01:38:51,696 IT DOESN'T MINE WE'LL EXPOSE YOU 2184 01:38:51,696 --> 01:38:54,899 TO A LOT MORE RISK, BUT WE'LL 2185 01:38:54,899 --> 01:38:56,567 PUT THIS THROUGH IN THE USUAL 2186 01:38:56,567 --> 01:38:59,203 WAY BUT PROVIDE ACCESS EARLIER. 2187 01:38:59,203 --> 01:39:02,507 SO, ONE WAY TO THINK ABOUT THAT 2188 01:39:02,507 --> 01:39:05,343 WOULD BE TO SAY HEY, HOLLY, YOU 2189 01:39:05,343 --> 01:39:10,081 SAID IT HAD TO GO THROUGH PHASE 2190 01:39:10,081 --> 01:39:12,917 I BEFORE ON PARALLEL TRACK. 2191 01:39:12,917 --> 01:39:14,319 YES, PHASE I IS JUST ABOUT 2192 01:39:14,319 --> 01:39:15,420 SAFETY AND YOU MAY SAY WHAT'S 2193 01:39:15,420 --> 01:39:16,888 THAT MEAN IN TERMS OF THEIR 2194 01:39:16,888 --> 01:39:22,060 EXPOSURE TO RISK AND I WOULD SAY 2195 01:39:22,060 --> 01:39:23,361 EVEN PHASE I RESEARCH IS 2196 01:39:23,361 --> 01:39:25,430 REVIEWED BY AN INSTITUTIONAL 2197 01:39:25,430 --> 01:39:27,131 REVIEW BOARD. 2198 01:39:27,131 --> 01:39:28,399 EVEN IF SOMEONE WAS WILLING AS 2199 01:39:28,399 --> 01:39:30,969 AN INDIVIDUAL TO MAKE A CHOICE 2200 01:39:30,969 --> 01:39:32,337 TO EXPOSE THEMSELVES TO A LEVEL 2201 01:39:32,337 --> 01:39:34,539 OF RISK THAT YOU AND I WOULD 2202 01:39:34,539 --> 01:39:36,874 THINK IS UNACCEPTABLE, THEY 2203 01:39:36,874 --> 01:39:37,508 CAN'T BECAUSE THE IRB IS STILL 2204 01:39:37,508 --> 01:39:40,578 IN PLACE. 2205 01:39:40,578 --> 01:39:42,413 SO THEY DIDN'T COMPROMISE ON THE 2206 01:39:42,413 --> 01:39:44,482 LEVEL OF RISK UP WITH BEING 2207 01:39:44,482 --> 01:39:46,417 EXPOSED TO IN A CLINICAL TRIAL 2208 01:39:46,417 --> 01:39:49,187 BUT MADE A CALCULATION THAT 2209 01:39:49,187 --> 01:39:51,789 SAID, AND THIS PARALLEL TRACK I 2210 01:39:51,789 --> 01:39:54,025 SHOULD MENTION IS BEYOND HIV. 2211 01:39:54,025 --> 01:39:59,397 IT ALSO APPLIED TO OTHER 2212 01:39:59,397 --> 01:40:06,204 TERMINAL DISEASES AND THERE'S 2213 01:40:06,204 --> 01:40:07,071 COMPASSIONATE USE AND AS THE 2214 01:40:07,071 --> 01:40:09,240 TIMES INDIVIDUALS CAN REQUEST 2215 01:40:09,240 --> 01:40:12,143 ACCESS TO A COMPOUND BEFORE IT'S 2216 01:40:12,143 --> 01:40:14,045 GONE THROUGH ALL OF THE LIKE AT 2217 01:40:14,045 --> 01:40:16,881 LEAST IN PHASE 1,IF NOT PHASE 2. 2218 01:40:16,881 --> 01:40:18,950 THERE CAN BE A REQUEST FOR 2219 01:40:18,950 --> 01:40:19,684 COMPASSIONATE USE. 2220 01:40:19,684 --> 01:40:21,219 THE PERSON HAS NO OTHER OPTIONS 2221 01:40:21,219 --> 01:40:23,087 AND THIS DRUG LOOKS LIKE IT 2222 01:40:23,087 --> 01:40:24,288 MIGHT BE HELPFUL. 2223 01:40:24,288 --> 01:40:25,723 WE DON'T KNOW. 2224 01:40:25,723 --> 01:40:27,258 WE CAN'T MAKE ANY GUARANTEE BUT 2225 01:40:27,258 --> 01:40:29,293 WE THINK THE RISK BENEFIT IS 2226 01:40:29,293 --> 01:40:31,162 ACCEPTABLE AND SO WE'RE GOING TO 2227 01:40:31,162 --> 01:40:33,331 ALLOW THEM TO HAVE EARLY ACCESS. 2228 01:40:33,331 --> 01:40:38,036 AND JUST AS AN ASIDE, THAT HAS 2229 01:40:38,036 --> 01:40:40,238 SHIFTED TO 2024 OF LIKE I DON'T 2230 01:40:40,238 --> 01:40:42,473 CARE WHAT ANY OF YOU SAY, STATES 2231 01:40:42,473 --> 01:40:45,176 HAVE IMPLEMENTED LAWS THAT SAY 2232 01:40:45,176 --> 01:40:47,078 YOU PATIENTS SHOULD HAVE ACCESS 2233 01:40:47,078 --> 01:40:50,314 TO ANYTHING YOU WANT THAT A 2234 01:40:50,314 --> 01:40:52,016 PHARMACEUTICAL COMPANY IS 2235 01:40:52,016 --> 01:40:53,551 DEVELOPING. 2236 01:40:53,551 --> 01:40:54,552 THE TRICK IS THE PHARMACEUTICAL 2237 01:40:54,552 --> 01:40:55,420 COMPANY ISN'T GOING TO SAY SURE, 2238 01:40:55,420 --> 01:40:56,888 YOU CAN HAVE IT. 2239 01:40:56,888 --> 01:40:59,023 IT'S ON THE BOOKS IT HASN'T HAD 2240 01:40:59,023 --> 01:41:02,226 MUCH OF AN IMPACT ON INDIVIDUAL 2241 01:41:02,226 --> 01:41:04,896 ACCESS TO THINGS THAT THEY THINK 2242 01:41:04,896 --> 01:41:07,565 MIGHT BE HELPFUL TO THEM THAT 2243 01:41:07,565 --> 01:41:08,166 HAVEN'T GONE THROUGH THE 2244 01:41:08,166 --> 01:41:09,300 APPROPRIATE SET OF CLINICAL 2245 01:41:09,300 --> 01:41:12,170 TRIALS. 2246 01:41:12,170 --> 01:41:12,437 >> THANKS. 2247 01:41:12,437 --> 01:41:14,005 >> IT'S A LONG ANSWER TO YOUR 2248 01:41:14,005 --> 01:41:14,272 QUESTION. 2249 01:41:14,272 --> 01:41:16,908 SO LET ME CHECK AND SEE ANYMORE 2250 01:41:16,908 --> 01:41:22,513 QUESTIONS FROM THE GROUP? 2251 01:41:22,513 --> 01:41:26,751 GREAT, DR. LANGFORD HAS EA 2252 01:41:26,751 --> 01:41:27,018 QUESTION. 2253 01:41:27,018 --> 01:41:28,186 >> MY QUESTION IS ABOUT 2254 01:41:28,186 --> 01:41:29,120 VULNERABLE POPULATIONS. 2255 01:41:29,120 --> 01:41:32,223 HISTORICALLY IT'S BEEN PREGNANT 2256 01:41:32,223 --> 01:41:34,325 WOMEN, CHILDREN AND PRISONERS 2257 01:41:34,325 --> 01:41:35,660 AND DURING COVID BUT NOT 2258 01:41:35,660 --> 01:41:36,861 EXCLUSIVELY WE TALKED ABOUT A 2259 01:41:36,861 --> 01:41:38,596 LOT OF PEOPLE BEING VULNERABLE 2260 01:41:38,596 --> 01:41:40,898 IN SOME WAYS THAT SUBJECTIVE 2261 01:41:40,898 --> 01:41:42,366 THAT WHO NEEDS PROTECTION BY 2262 01:41:42,366 --> 01:41:44,969 SCIENTISTS VERSUS WHO SHOULD 2263 01:41:44,969 --> 01:41:48,106 HAVE THE RIGHT TO BE INVITED AND 2264 01:41:48,106 --> 01:41:49,107 MAKE THEIR OWN DECISIONS. 2265 01:41:49,107 --> 01:41:51,109 TALK ABOUT THE EVOLUTION AND HOW 2266 01:41:51,109 --> 01:41:52,276 WE USE THE TERM APPROPRIATELY 2267 01:41:52,276 --> 01:41:55,146 AND SOMETIMES IN MY OPINION 2268 01:41:55,146 --> 01:41:55,513 INAPPROPRIATELY. 2269 01:41:55,513 --> 01:41:58,816 >> YES, SO I THINK WE AGREE. 2270 01:41:58,816 --> 01:42:02,053 SO, BEEN AS A REMINDER, THERE 2271 01:42:02,053 --> 01:42:08,192 ARE THREE GROUPS THAT ARE 2272 01:42:08,192 --> 01:42:11,229 OFFICIALLY DESIGNATED, PREGNANT 2273 01:42:11,229 --> 01:42:12,897 WOMEN, PRISONERS AND CHILDREN. 2274 01:42:12,897 --> 01:42:14,932 AND THERE ARE ALL SORTS OF WAYS 2275 01:42:14,932 --> 01:42:16,167 WE COULD SAY, EVERYONE IS 2276 01:42:16,167 --> 01:42:21,873 VULNERABLE WHICH IS NOT HELPFUL 2277 01:42:21,873 --> 01:42:26,444 AND THEN WE MIGHT BE TEMPTED TO 2278 01:42:26,444 --> 01:42:31,616 IDENTIFY GROUPS THAT ARE 2279 01:42:31,616 --> 01:42:32,884 VULNERABLE. 2280 01:42:32,884 --> 01:42:38,189 LET'S SAY I'M ABOUT TO DO MY 2281 01:42:38,189 --> 01:42:40,258 CLINICAL TRIAL AND I SAY YOU'RE 2282 01:42:40,258 --> 01:42:40,892 VULNERABLE BECAUSE YOU ARE MY 2283 01:42:40,892 --> 01:42:43,127 STUDENTS AND I CAN MAKE YOU DO 2284 01:42:43,127 --> 01:42:48,900 WHATEVER I WANT IN ORDER TO PASS 2285 01:42:48,900 --> 01:42:52,870 MY CLASS THERE'S A POWER 2286 01:42:52,870 --> 01:42:53,137 IMBALANCE. 2287 01:42:53,137 --> 01:42:55,473 ONE COULD SAY HOLLY COULD TAKE 2288 01:42:55,473 --> 01:42:58,209 ADVANTAGE OF HER POWER IMBALANCE 2289 01:42:58,209 --> 01:43:08,686 AND COULD EXPLOIT THE GROUP. 2290 01:43:09,020 --> 01:43:11,422 ANOTHER WAY OF SAYING IT IS 2291 01:43:11,422 --> 01:43:13,157 PEOPLE CAN BENEFIT FROM THE 2292 01:43:13,157 --> 01:43:15,193 RESEARCH AND IF THERE'S THE 2293 01:43:15,193 --> 01:43:17,628 POWER IMBALANCE WHY NOT TAKE 2294 01:43:17,628 --> 01:43:19,664 HOLLY OUT OF THE PICTURE AND 2295 01:43:19,664 --> 01:43:20,598 HAVE SOMEONE OTHER THAN HOLLY 2296 01:43:20,598 --> 01:43:28,439 INTRODUCE THE TRIAL. 2297 01:43:28,439 --> 01:43:29,874 AND IF YOU DON'T WANT TO DO IT 2298 01:43:29,874 --> 01:43:31,108 THEY ARE WON'T REPORT TO ME WHO 2299 01:43:31,108 --> 01:43:33,578 DID AND DIDN'T DO IT. 2300 01:43:33,578 --> 01:43:35,379 WHILE YOU'RE VULNERABLE AND 2301 01:43:35,379 --> 01:43:37,215 YOU'RE A CLASS OF PEOPLE 2302 01:43:37,215 --> 01:43:43,020 VULNERABLE, WE CAN TAKE ACTIONS 2303 01:43:43,020 --> 01:43:48,893 TO MAKE YOU AND TAKE OUT THE 2304 01:43:48,893 --> 01:43:50,228 THING THAT MIGHT EXPLOIT YOU. 2305 01:43:50,228 --> 01:43:52,897 THAT'S ONE WAY TO THINK ABOUT IT 2306 01:43:52,897 --> 01:43:57,835 AND OTHER WAY I WAS REFERRING TO 2307 01:43:57,835 --> 01:44:04,075 WE TALKED ABOUT THE TUSKEGEE 2308 01:44:04,075 --> 01:44:07,445 STUDY AND I'M AN INVESTIGATOR 2309 01:44:07,445 --> 01:44:09,714 AND I KNOW PEOPLE WHO ARE NOT 2310 01:44:09,714 --> 01:44:14,452 WHITE ARE AFRAID OF RESEARCH AND 2311 01:44:14,452 --> 01:44:16,487 I DON'T WANT TO SHARE THEM SO 2312 01:44:16,487 --> 01:44:16,988 I'M NOT GOING TO OFFER 2313 01:44:16,988 --> 01:44:27,331 ENROLLMENT TO THEM. 2314 01:44:27,531 --> 01:44:28,332 I'M MAKING HUGE ASSUMPTIONS AND 2315 01:44:28,332 --> 01:44:30,301 I PULLED IT FROM THE AIR AND 2316 01:44:30,301 --> 01:44:31,335 APPLIED IT TO EVERYBODY AND SAID 2317 01:44:31,335 --> 01:44:36,607 THEREFORE ALL OF YOU ARE 2318 01:44:36,607 --> 01:44:36,907 VULNERABLE. 2319 01:44:36,907 --> 01:44:39,210 I'M NOT EVEN GOING TO APPROACH. 2320 01:44:39,210 --> 01:44:39,677 I HOPE YOU SEE THAT'S 2321 01:44:39,677 --> 01:44:46,951 INAPPROPRIATE. 2322 01:44:46,951 --> 01:44:54,525 THAT'S ACONTRIBUTING SOMETHING 2323 01:44:54,525 --> 01:44:56,193 AND THAT'S NOT THE CASE BUT WE 2324 01:44:56,193 --> 01:45:00,898 ARE ALL VULNERABLE TO USE IN A 2325 01:45:00,898 --> 01:45:01,565 PUN. 2326 01:45:01,565 --> 01:45:02,333 WE'RE ALL VULNERABLE TO MAKING 2327 01:45:02,333 --> 01:45:09,874 ASSUMPTIONS. 2328 01:45:09,874 --> 01:45:11,075 IT'S RICKY WHEN WE MAKE 2329 01:45:11,075 --> 01:45:12,910 ASSUMPTIONS ABOUT WHO IS 2330 01:45:12,910 --> 01:45:19,884 VULNERABLE AND WHO ISN'T. 2331 01:45:19,884 --> 01:45:21,719 COLLOQUIALLY IT'S IMPORTANT AS 2332 01:45:21,719 --> 01:45:23,587 WAS IT IN ABOUT WHAT DR. ASADA 2333 01:45:23,587 --> 01:45:24,889 WAS SAYING. 2334 01:45:24,889 --> 01:45:29,627 IT'S REALLY IMPORTANT TO SAY 2335 01:45:29,627 --> 01:45:31,028 WHAT DO YOU MEAN BY VULNERABLE. 2336 01:45:31,028 --> 01:45:32,196 YOU SAID EVERYBODY IN THE ROOM 2337 01:45:32,196 --> 01:45:32,897 IS VULNERABLE. 2338 01:45:32,897 --> 01:45:35,633 WHY ARE THEY VULNERABLE? 2339 01:45:35,633 --> 01:45:38,202 I WOULD SAY WELL, THERE'S A 2340 01:45:38,202 --> 01:45:40,771 POWER IMBALANCE. 2341 01:45:40,771 --> 01:45:41,038 GOOD. 2342 01:45:41,038 --> 01:45:43,674 NOW WE'VE DEFINED WHAT IS IT 2343 01:45:43,674 --> 01:45:50,181 BEHIND THE VULNERABILITY. 2344 01:45:50,181 --> 01:45:51,515 VERSUS, I READ IN THE NEWSPAPER 2345 01:45:51,515 --> 01:45:52,883 PEOPLE WHITE OR AFRAID OF 2346 01:45:52,883 --> 01:45:53,351 CLINICAL TRIALS. 2347 01:45:53,351 --> 01:45:55,252 THAT'S WHY I THINK THEY'RE 2348 01:45:55,252 --> 01:45:55,853 VULNERABLE. 2349 01:45:55,853 --> 01:46:00,891 THAT WOULD BE SOMETHING TO 2350 01:46:00,891 --> 01:46:05,863 CRITIQUE, TO CHALLENGE. 2351 01:46:05,863 --> 01:46:16,374 LET ME SEE IF THERE ARE LET'S 2352 01:46:21,479 --> 01:46:22,913 SEE IF THERE'S A QUESTION IN 2353 01:46:22,913 --> 01:46:24,882 VIDEO LAND. 2354 01:46:24,882 --> 01:46:27,551 ARE EMPLOYEES OF ANY INSTITUTE 2355 01:46:27,551 --> 01:46:30,454 CONSIDERED VULNERABLE AS STUDY 2356 01:46:30,454 --> 01:46:30,788 PARTICIPANTS? 2357 01:46:30,788 --> 01:46:32,890 IF SO, HOW DO YOU MITIGATE THE 2358 01:46:32,890 --> 01:46:34,091 EFFECT OF VULNERABILITY. 2359 01:46:34,091 --> 01:46:36,127 QUITE ON TARGET. 2360 01:46:36,127 --> 01:46:38,229 I'LL TELL YOU A LITTLE BIT ABOUT 2361 01:46:38,229 --> 01:46:38,996 HOW THE CLINICAL CENTER HANDLES 2362 01:46:38,996 --> 01:46:43,534 THIS. 2363 01:46:43,534 --> 01:46:46,637 AS I REMINDER WE ARE IN A VERY 2364 01:46:46,637 --> 01:46:47,838 LARGE HOSPITAL AND THERE ARE 2365 01:46:47,838 --> 01:46:50,674 CLINICAL TRIALS GOING ON ALL THE 2366 01:46:50,674 --> 01:46:51,008 TIME. 2367 01:46:51,008 --> 01:46:53,677 AND WE AS EMPLOYEES OF THE 2368 01:46:53,677 --> 01:46:55,479 CLINICAL CENTER CAN JOIN LISTS 2369 01:46:55,479 --> 01:46:57,314 OF IF YOU WANT TO VOLUNTEER FOR 2370 01:46:57,314 --> 01:46:59,784 A STUDY, PUT YOUR NAME HERE ON 2371 01:46:59,784 --> 01:47:02,219 THIS REGISTER. 2372 01:47:02,219 --> 01:47:07,258 SO WE RECEIVE ALL SORTS OF 2373 01:47:07,258 --> 01:47:09,326 E-MAIL THAT SAY COME JOIN MY 2374 01:47:09,326 --> 01:47:09,693 STUDY. 2375 01:47:09,693 --> 01:47:11,896 NOW, WE'RE ALL ALLOWED AS 2376 01:47:11,896 --> 01:47:13,464 CLINICAL CENTER EMPLOYEES TO 2377 01:47:13,464 --> 01:47:14,231 PICK AND CHOOSE WHICH TRIALS WE 2378 01:47:14,231 --> 01:47:23,874 WANT TO BE IN. 2379 01:47:23,874 --> 01:47:26,143 THE FOLLOWING HAPPENS WHEN IT'S 2380 01:47:26,143 --> 01:47:29,447 MY TRIAL AND BRITNEY WORKS IN MY 2381 01:47:29,447 --> 01:47:38,222 LAB AND I SUPERVISE HERE AND THE 2382 01:47:38,222 --> 01:47:39,557 WORRY IS THE POWER IMBALANCE. 2383 01:47:39,557 --> 01:47:41,492 IF I SAY YOU KNOW TRIAL IS 2384 01:47:41,492 --> 01:47:43,694 OPENING TODAY AND PLEASE GO DOWN 2385 01:47:43,694 --> 01:47:46,130 AND RECALL OR RESPOND TO THE 2386 01:47:46,130 --> 01:47:48,899 RECRUITMENT E-MAIL OR WHATEVER, 2387 01:47:48,899 --> 01:47:51,435 BRITTANY MIGHT WORRY, OH, NO, IF 2388 01:47:51,435 --> 01:47:54,438 I DON'T ENROLL I MAY BE IN 2389 01:47:54,438 --> 01:47:55,239 TROUBLE FROM HOLLY. 2390 01:47:55,239 --> 01:47:59,143 I WAS GOING TO GO TO THE 2391 01:47:59,143 --> 01:48:02,613 CONFERENCE, MAYBE SHE'LL RESCIND 2392 01:48:02,613 --> 01:48:05,783 THE PERMISSION AND CLINICAL 2393 01:48:05,783 --> 01:48:08,319 CENTER IS AWARE OF THE POWER 2394 01:48:08,319 --> 01:48:15,526 IMBALANCE AND THIS IS A DIRECT 2395 01:48:15,526 --> 01:48:18,062 ROLE, THEY CONTACT THE BIOETHICS 2396 01:48:18,062 --> 01:48:22,500 SERVICE AND THEY SAY YOU HAVE AN 2397 01:48:22,500 --> 01:48:23,801 EMPLOYEE IN YOUR DIRECT 2398 01:48:23,801 --> 01:48:24,869 SUPERVISORY LINE WHO WANTS TO 2399 01:48:24,869 --> 01:48:26,937 ENROLL, WE CAN COME AND TALK 2400 01:48:26,937 --> 01:48:28,172 WITH THEM TO MAKE SURE THEY 2401 01:48:28,172 --> 01:48:30,174 UNDERSTAND WHAT THEY'RE GETTING 2402 01:48:30,174 --> 01:48:31,208 INTO AND APPRECIATE THEY DON'T 2403 01:48:31,208 --> 01:48:36,881 FEEL ADDITIONAL PRESSURE, 2404 01:48:36,881 --> 01:48:39,717 ETCETERA. 2405 01:48:39,717 --> 01:48:42,820 THE POLICY IS ACKNOWLEDGING THE 2406 01:48:42,820 --> 01:48:44,188 POWER IMBALANCE AND THE 2407 01:48:44,188 --> 01:48:44,989 MECHANISM TO ALLOW FOR A 2408 01:48:44,989 --> 01:48:50,027 CONVERSATION FOR THE PERSON TO 2409 01:48:50,027 --> 01:49:00,571 BOTH APPRECIATE WHAT THAT MEANS 2410 01:49:03,974 --> 01:49:08,178 AND SHE SHOULD FEEL FREE OF 2411 01:49:08,178 --> 01:49:09,446 PRESSURE AND TELL US THAT. 2412 01:49:09,446 --> 01:49:11,048 THE TRICKY PART IS THE 2413 01:49:11,048 --> 01:49:11,315 FOLLOWING. 2414 01:49:11,315 --> 01:49:13,984 HERE AT THE CLINICAL CENTER WE 2415 01:49:13,984 --> 01:49:19,423 HAVE AN ELECTRONIC HEALTH 2416 01:49:19,423 --> 01:49:19,657 RECORD. 2417 01:49:19,657 --> 01:49:20,891 EVERYBODY IS IN RESEARCH. 2418 01:49:20,891 --> 01:49:23,627 THERE AREN'T PATIENTS AND 2419 01:49:23,627 --> 01:49:24,395 RESEARCH POPULATIONS. 2420 01:49:24,395 --> 01:49:25,996 THERE'S JUST ONE ELECTRONIC 2421 01:49:25,996 --> 01:49:26,597 HEALTH RECORD FOR EVERYONE IN 2422 01:49:26,597 --> 01:49:36,774 RESEARCH. 2423 01:49:37,775 --> 01:49:40,878 BRITTANY NEEDS TO KNOW WE NEED 2424 01:49:40,878 --> 01:49:46,483 ACCESS TO ONLY DE-IDENTIFIED 2425 01:49:46,483 --> 01:49:48,218 DATA BUT SAY I CAN LOOK AT 2426 01:49:48,218 --> 01:49:50,588 EVERYONE WHO CONSENTED TO MY 2427 01:49:50,588 --> 01:49:51,188 TRIAL. 2428 01:49:51,188 --> 01:49:54,658 YOU CAN SEARCH ON THAT AND 2429 01:49:54,658 --> 01:49:55,192 BRITT 2430 01:49:55,192 --> 01:49:56,260 BRITTANY'S NAME IS GOING TO POP 2431 01:49:56,260 --> 01:49:58,128 UP OR NOT. 2432 01:49:58,128 --> 01:49:59,763 I SHOULDN'T BE CHECKING THAT TO 2433 01:49:59,763 --> 01:50:01,865 SEE WHETHER OR NOT PEOPLE IN MY 2434 01:50:01,865 --> 01:50:03,334 LAB HAVE DONE IT. 2435 01:50:03,334 --> 01:50:07,237 BUT IT'S A RISK I WANT BRITTANY 2436 01:50:07,237 --> 01:50:08,205 TO KNOW. 2437 01:50:08,205 --> 01:50:09,974 I NEED HER TO KNOW HER 2438 01:50:09,974 --> 01:50:11,842 INFORMATION WILL BE IN THE 2439 01:50:11,842 --> 01:50:12,776 ELECTRONIC HEALTH RECORD. 2440 01:50:12,776 --> 01:50:14,044 IT MAY ALSO BE AVAILABLE TO 2441 01:50:14,044 --> 01:50:15,446 OTHERS ON THE STUDY TEAM AND 2442 01:50:15,446 --> 01:50:17,081 THAT'S IMPORTANT TO KEEP IN 2443 01:50:17,081 --> 01:50:21,852 MIND. 2444 01:50:21,852 --> 01:50:22,720 YOU MIGHT HAVE SENSITIVE 2445 01:50:22,720 --> 01:50:24,321 INFORMATION ABOUT YOURSELF YOU 2446 01:50:24,321 --> 01:50:27,858 WANT TO KEEP PRIVATE YOU 2447 01:50:27,858 --> 01:50:29,927 WOULDN'T WANT EVERYONE TO KNOW 2448 01:50:29,927 --> 01:50:30,861 OR MAYBE YOU'D ANSWER MORE 2449 01:50:30,861 --> 01:50:32,896 VAGUELY AND THEN YOU THINK, WAIT 2450 01:50:32,896 --> 01:50:35,032 A SECOND, IF I'M ACTUALLY 2451 01:50:35,032 --> 01:50:37,201 WILLING TO ANSWER A QUESTION 2452 01:50:37,201 --> 01:50:39,436 VAGUELY OR INCORRECTLY WHEN THEY 2453 01:50:39,436 --> 01:50:41,238 ARE ASK ME, THAT HAS SOMETHING 2454 01:50:41,238 --> 01:50:43,974 TO DO WITH THE INTEGRITY OF THE 2455 01:50:43,974 --> 01:50:44,174 STUDY. 2456 01:50:44,174 --> 01:50:44,975 I SHOULDN'T ENROLL. 2457 01:50:44,975 --> 01:50:46,844 ALL TO SAY IT'S NOT EASY BUT 2458 01:50:46,844 --> 01:50:48,445 THERE'S A MECHANISM IN PLACE 2459 01:50:48,445 --> 01:50:52,483 HERE AT THE CLINICAL CENTER TO 2460 01:50:52,483 --> 01:50:53,884 HOPEFULLY PROVIDE AN OPPORTUNITY 2461 01:50:53,884 --> 01:50:55,753 FOR THE DISCUSSION ABOUT WHAT IT 2462 01:50:55,753 --> 01:50:56,654 MEANS TO BE AN EMPLOYEE 2463 01:50:56,654 --> 01:50:59,390 ENROLLING IN A STUDY THAT IS RUN 2464 01:50:59,390 --> 01:51:04,428 BY YOUR OWN LAB. 2465 01:51:04,428 --> 01:51:04,628 OKAY. 2466 01:51:04,628 --> 01:51:06,063 THANK YOU ALL, WITH THAT WE'LL 2467 01:51:06,063 --> 01:51:07,865 TAKE OUR BREAK. 2468 01:51:07,865 --> 01:51:10,734 IT'S 10:20. 2469 01:51:10,734 --> 01:51:12,670 WE'LL RETURN AT 10:35, 15 2470 01:51:12,670 --> 01:51:14,705 MINUTES FROM NOW AND WE'LL THEN 2471 01:51:14,705 --> 01:51:16,507 HAVE OUR LAST AND FINAL LECTURE 2472 01:51:16,507 --> 01:51:16,774 FOR TODAY. 2473 01:51:16,774 --> 01:51:23,327 THANK YOU ALL. 2474 01:51:23,327 --> 01:51:26,196 WELCOME BACK TO OUR FINAL 2475 01:51:26,196 --> 01:51:30,067 LECTURE WE HAVE A GUEST, AISHA 2476 01:51:30,067 --> 01:51:32,602 LANGFORD VISITING FROM WAYNE 2477 01:51:32,602 --> 01:51:34,371 STATE AN ASSOCIATE PROFESSOR IN 2478 01:51:34,371 --> 01:51:35,672 THE DEPARTMENT OF FAMILY 2479 01:51:35,672 --> 01:51:37,674 MEDICINE AND PUBLIC HEALTH 2480 01:51:37,674 --> 01:51:37,941 SCIENCES. 2481 01:51:37,941 --> 01:51:40,210 HER RESEARCH PRIMARILY FOCUSES 2482 01:51:40,210 --> 01:51:41,712 ON THE WAY IN WHICH HEALTH 2483 01:51:41,712 --> 01:51:43,046 COMMUNICATIONS CAN ENHANCE 2484 01:51:43,046 --> 01:51:46,850 INDIVIDUAL DECISION MAKING AND 2485 01:51:46,850 --> 01:51:48,418 REDUCE HEALTH DISPARITIES ALONG 2486 01:51:48,418 --> 01:51:49,286 THE THEME AND SPECIFICALLY IS 2487 01:51:49,286 --> 01:51:52,122 GOING TO TALK TO US ABOUT 2488 01:51:52,122 --> 01:51:52,689 RECRUITMENT AND RETENTION. 2489 01:51:52,689 --> 01:52:02,933 TAKE IT AWAY. 2490 01:52:04,901 --> 01:52:09,139 THANKS GOOD, DR. TAYLOR AND WANT 2491 01:52:09,139 --> 01:52:11,575 TO YOU CAN TO TALK ABOUT 2492 01:52:11,575 --> 01:52:15,012 RECRUITMENT AND RETENTION IN 2493 01:52:15,012 --> 01:52:24,654 HEALTH RESEARCH STUDIES. 2494 01:52:24,654 --> 01:52:26,990 I DON'T HAVE CONFLICTS OF 2495 01:52:26,990 --> 01:52:29,526 INTEREST. 2496 01:52:29,526 --> 01:52:34,598 YOU ALL PROBABLY NOTICED 2497 01:52:34,598 --> 01:52:35,999 CLINICAL TRIALS ARE DIVERSE IN 2498 01:52:35,999 --> 01:52:36,900 TOPIC. 2499 01:52:36,900 --> 01:52:38,702 THERE'S BEHAVIORAL STUDIES, 2500 01:52:38,702 --> 01:52:40,037 GENETIC STUDIES, PEOPLE WHO 2501 01:52:40,037 --> 01:52:42,406 CHOOSE TO PARTICIPATE IN SURGERY 2502 01:52:42,406 --> 01:52:43,707 STUDIES OR DRUG TRIALS OR 2503 01:52:43,707 --> 01:52:44,307 VACCINE TRIALS. 2504 01:52:44,307 --> 01:52:48,245 OR TRIALS THAT ARE FOCUSSED ON 2505 01:52:48,245 --> 01:52:51,248 SOCIAL SUPPORT OR LIKE SYMPTOM 2506 01:52:51,248 --> 01:52:51,548 MANAGEMENT. 2507 01:52:51,548 --> 01:52:56,253 THERE'S ALSO DIFFERENT PHASES OF 2508 01:52:56,253 --> 01:53:03,827 CLINICAL TRIALS, PHASE I AND II 2509 01:53:03,827 --> 01:53:06,496 AND III AND I'VE BEEN IN A TRIAL 2510 01:53:06,496 --> 01:53:07,931 AND THE TARGET POPULATION CAN 2511 01:53:07,931 --> 01:53:08,965 DIFFER. 2512 01:53:08,965 --> 01:53:10,567 IN SOME POPULATIONS WE FOCUS ON 2513 01:53:10,567 --> 01:53:10,834 CHILDREN. 2514 01:53:10,834 --> 01:53:12,469 IN SOME SITUATIONS WE MAY FOCUS 2515 01:53:12,469 --> 01:53:13,870 ON OLDER ADULT OR FAMILIES AND 2516 01:53:13,870 --> 01:53:18,875 IN SOME SITUATIONS WE MAY 2517 01:53:18,875 --> 01:53:20,043 ACTUALLY BE FOCUSSING 2518 01:53:20,043 --> 01:53:20,777 EXCLUSIVELY OR PRIMARILY ON 2519 01:53:20,777 --> 01:53:26,083 PREGNANT WOMEN. 2520 01:53:26,083 --> 01:53:29,986 SO, BEFORE WE ACTUALLY GET 2521 01:53:29,986 --> 01:53:31,388 STARTED JUST IMAGINE YOU HAVE A 2522 01:53:31,388 --> 01:53:31,855 NEIGHBOR. 2523 01:53:31,855 --> 01:53:34,124 HER NAME IS LINDA AND SHE KNOWS 2524 01:53:34,124 --> 01:53:36,827 YOU EITHER WORK AT NIH OR ARE 2525 01:53:36,827 --> 01:53:37,828 VERY INTERESTED IN CLINICAL 2526 01:53:37,828 --> 01:53:39,563 TRIALS AND HEALTH RESEARCH AND 2527 01:53:39,563 --> 01:53:41,965 SHE'S TRYING TO FIND A CLINICAL 2528 01:53:41,965 --> 01:53:44,367 TRIAL FOR PEOPLE LIVING WITH 2529 01:53:44,367 --> 01:53:46,703 TYPE II DIABETES AND IF SHE CAME 2530 01:53:46,703 --> 01:53:47,737 TO YOUR DOOR TONIGHT AND ASKED 2531 01:53:47,737 --> 01:53:50,207 FOR YOUR HELP, WHERE WOULD YOU 2532 01:53:50,207 --> 01:53:53,710 START IF YOU WANTED TO HELP HER 2533 01:53:53,710 --> 01:53:54,911 FIND A CLINICAL TRIAL FOR TYPE 2534 01:53:54,911 --> 01:53:56,713 II DIABETES OF ALL PLACES WHERE 2535 01:53:56,713 --> 01:53:57,214 WOULD YOU START? 2536 01:53:57,214 --> 01:54:04,621 I BELIEVE WE HAVE A SLIDO. 2537 01:54:04,621 --> 01:54:06,990 >> FOR THOSE WHO NEED THE NUMBER 2538 01:54:06,990 --> 01:54:13,029 IT'S 2997631. 2539 01:54:13,029 --> 01:54:14,831 SLIDO.COM IS WHERE YOU'LL GO AND 2540 01:54:14,831 --> 01:54:16,066 PUT IN THE NUMBER. 2541 01:54:16,066 --> 01:54:22,339 THE SAME USED FOR THE PREVIOUS 2542 01:54:22,339 --> 01:54:24,508 QUESTIONS UP WITH OF YOU HAS 2543 01:54:24,508 --> 01:54:35,051 RESPONDED SO I NEED MORE OF YOU. 2544 01:54:42,325 --> 01:54:42,759 NOW AMERICAN DIABETES 2545 01:54:42,759 --> 01:54:45,695 ASSOCIATION IS COMING UP AND 2546 01:54:45,695 --> 01:54:47,864 THERE'S A HAND UP. 2547 01:54:47,864 --> 01:54:58,208 THE CODE IS 2997361. 2548 01:55:01,144 --> 01:55:02,312 ACADEMIC CENTER AND DIABETES 2549 01:55:02,312 --> 01:55:05,148 ASSOCIATION ARE NECK AND NECK. 2550 01:55:05,148 --> 01:55:06,850 CLINICAL TRIALS IS WINNING AT 2551 01:55:06,850 --> 01:55:07,083 79%. 2552 01:55:07,083 --> 01:55:14,958 WE HAVE A COUPLE VOTES FOR NIDDK 2553 01:55:14,958 --> 01:55:22,032 BUT CLINICAL TRIALS DOT-GOV IS 2554 01:55:22,032 --> 01:55:26,002 THE CLEAR WINNER. 2555 01:55:26,002 --> 01:55:26,636 MOST PEOPLE CHOSE CLINICAL 2556 01:55:26,636 --> 01:55:28,738 TRIALS.gov AND WE'LL TALK MORE 2557 01:55:28,738 --> 01:55:30,006 ABOUT THAT LATER. 2558 01:55:30,006 --> 01:55:33,410 SO BEFORE WE GET IN DEPTH INTO 2559 01:55:33,410 --> 01:55:37,180 STRATEGIES AND WAYS OF 2560 01:55:37,180 --> 01:55:39,416 RECRUITMENT AND RETENTION I WANT 2561 01:55:39,416 --> 01:55:41,851 TO HIGHLIGHT EXAMPLE MODELS. 2562 01:55:41,851 --> 01:55:43,553 SO THIS MODEL BY FORD AND 2563 01:55:43,553 --> 01:55:50,227 COLLEAGUES IS ONE OF THE FIRST 2564 01:55:50,227 --> 01:55:55,565 THE CLINICAL TRIALS CONCEPTUAL 2565 01:55:55,565 --> 01:55:57,234 FRAMEWORKS AND POSIT THAT 2566 01:55:57,234 --> 01:56:00,470 BARRIERS CAN BE CATEGORIZED AS 2567 01:56:00,470 --> 01:56:02,472 AWARENESS BARRIERS OR PROMOTERS 2568 01:56:02,472 --> 01:56:03,673 OR OPPORTUNITY BARRIERS OR 2569 01:56:03,673 --> 01:56:06,977 PROMOTERS AND ACCEPTANCE OR 2570 01:56:06,977 --> 01:56:07,344 REFUSAL. 2571 01:56:07,344 --> 01:56:12,315 SO AWARENESS, OPPORTUNITIES AND 2572 01:56:12,315 --> 01:56:13,550 THINGS THAT CAN POTENTIALLY 2573 01:56:13,550 --> 01:56:15,018 IMPACT PEOPLE'S DECISION TO 2574 01:56:15,018 --> 01:56:15,452 PARTICIPATE. 2575 01:56:15,452 --> 01:56:18,588 THIS IS ONE OF THE EARLIEST 2576 01:56:18,588 --> 01:56:19,456 FRAME WORKS I'VE BEEN INVOLVED 2577 01:56:19,456 --> 01:56:21,224 IN THOUGH I'M SURE THERE'S MANY. 2578 01:56:21,224 --> 01:56:24,527 KEEP THAT IN THE BACK OF YOUR 2579 01:56:24,527 --> 01:56:24,894 MIND. 2580 01:56:24,894 --> 01:56:27,230 AND THEN MORE -- WELL, 2581 01:56:27,230 --> 01:56:28,698 RELATIVELY MORE RECENT ONE THE 2582 01:56:28,698 --> 01:56:30,267 PRIOR ONE WAS PUSH ESTABLISHED 2583 01:56:30,267 --> 01:56:36,039 IN 2007 AND IN PRINT IN 2008 AND 2584 01:56:36,039 --> 01:56:38,208 IN 2021, WILKENS AND COLLEAGUES 2585 01:56:38,208 --> 01:56:40,910 PARTS OF THEIR INVOLVEMENT WITH 2586 01:56:40,910 --> 01:56:42,746 THE RECRUITMENT INNOVATION 2587 01:56:42,746 --> 01:56:44,514 CENTER, THE RECRUITMENT 2588 01:56:44,514 --> 01:56:46,750 INNOVATION CENTER IS PART OF THE 2589 01:56:46,750 --> 01:56:47,517 TRIAL INNOVATION NETWORK WHICH 2590 01:56:47,517 --> 01:56:50,787 IS FUNDED BY THE NATIONAL CENTER 2591 01:56:50,787 --> 01:56:54,691 FOR ADVANCING TRANSLATIONAL 2592 01:56:54,691 --> 01:56:56,526 SCIENCES AND THAT'SED PART OF 2593 01:56:56,526 --> 01:56:56,693 NIH. 2594 01:56:56,693 --> 01:57:01,097 SO THEY PUT FORTH THIS 2595 01:57:01,097 --> 01:57:03,033 CONCEPTUAL MODEL OF PARTICIPANT 2596 01:57:03,033 --> 01:57:06,269 RECRUITMENT EFFORTS AND MOST ARE 2597 01:57:06,269 --> 01:57:07,237 PRETTY EXPLANATORY. 2598 01:57:07,237 --> 01:57:09,306 THERE'S AWARENESS, HOW THEY 2599 01:57:09,306 --> 01:57:10,974 CONCEPTUALIZE FEASIBILITY IS 2600 01:57:10,974 --> 01:57:13,376 MORE FROM THE CONCEPT OF MAKING 2601 01:57:13,376 --> 01:57:16,479 SURE YOU HAVE INELIGIBLE 2602 01:57:16,479 --> 01:57:21,651 POPULATIONS AND MAY BE ACCESS 2603 01:57:21,651 --> 01:57:25,622 FEASIBILITY THROUGH THINGS LI 2604 01:57:25,622 --> 01:57:28,425 LILIKE 2605 01:57:28,425 --> 01:57:29,392 ELECTRONIC HEALTH RECORDS AND DO 2606 01:57:29,392 --> 01:57:30,660 THEY KNOW TOOLS ARE AVAILABLE 2607 01:57:30,660 --> 01:57:35,932 AND SCREENING, INVITATIONS TO 2608 01:57:35,932 --> 01:57:37,967 PARTICIPATE AND IT'S GREAT TO 2609 01:57:37,967 --> 01:57:38,802 HAVE CLINICAL TRIALS BUT YOU 2610 01:57:38,802 --> 01:57:44,107 HAVE TO HAVE WAYS TO INVITE AND 2611 01:57:44,107 --> 01:57:45,308 CONSENT AND IF PEOPLE THINK THIS 2612 01:57:45,308 --> 01:57:47,544 THROUGH THEY'LL GO ON TO ENROLL 2613 01:57:47,544 --> 01:57:49,346 IN THE TRIAL AND THEN ENGAGEMENT 2614 01:57:49,346 --> 01:57:50,313 AND RETENTION THROUGHOUT THE 2615 01:57:50,313 --> 01:57:50,647 TRIAL. 2616 01:57:50,647 --> 01:57:52,382 IT'S REALLY ABOUT COMMUNICATION 2617 01:57:52,382 --> 01:57:53,783 AND MAKING PEOPLE FEEL LIKE THEY 2618 01:57:53,783 --> 01:57:58,254 HAVE SOME SENSE OF CONNECTEDNESS 2619 01:57:58,254 --> 01:57:59,556 AND THIN THEY TALK ABOUT RETURN 2620 01:57:59,556 --> 01:58:01,658 OF VALUE AND HOW THEY 2621 01:58:01,658 --> 01:58:02,892 CONCEPTUALIZE RETURN OF VALUE IS 2622 01:58:02,892 --> 01:58:05,595 THE IDEA OF GETTING OR GIVING 2623 01:58:05,595 --> 01:58:07,564 BACK INDIVIDUAL RESULTS AND ALSO 2624 01:58:07,564 --> 01:58:11,201 STUDY RESULTS TO PARTICIPANTS 2625 01:58:11,201 --> 01:58:13,303 EVEN IF IT'S NOT CLINICALLY 2626 01:58:13,303 --> 01:58:18,341 MEANINGFUL BUT THEY TALK ABOUT 2627 01:58:18,341 --> 01:58:22,178 REALLY THE RETURN OF INFORMATION 2628 01:58:22,178 --> 01:58:27,016 AS THE RESPECT FOR PERSONS. 2629 01:58:27,016 --> 01:58:31,588 THEN FINALLY, THIS IS ACTUALLY 2630 01:58:31,588 --> 01:58:33,022 MY CONCEPTUAL MODEL WHICH 2631 01:58:33,022 --> 01:58:35,625 IRONICALLY I PUBLISHED IN A 2632 01:58:35,625 --> 01:58:37,160 SPECIAL SUPPLEMENT FOCUSSED ON 2633 01:58:37,160 --> 01:58:38,762 VACCINE CLINICAL TRIALS. 2634 01:58:38,762 --> 01:58:40,196 SO THIS WAS IN THE JOURNAL OF 2635 01:58:40,196 --> 01:58:43,967 HEALTH COMMUNICATION AND SO THIS 2636 01:58:43,967 --> 01:58:46,636 IS A GENERAL MODEL OF CLINICAL 2637 01:58:46,636 --> 01:58:47,937 TRIAL PARTICIPATION DEVELOPING 2638 01:58:47,937 --> 01:58:50,507 FOR MANY YEARS AND FINALLY GOT 2639 01:58:50,507 --> 01:58:51,574 IT PUBLISHED DURING COVID. 2640 01:58:51,574 --> 01:58:54,511 I'M NOT GOING TO GO OVER EVERY 2641 01:58:54,511 --> 01:58:56,980 SINGLE BULLET POINT BUT I JUST 2642 01:58:56,980 --> 01:59:00,016 WANT US TO APPRECIATE THAT A LOT 2643 01:59:00,016 --> 01:59:05,054 OF THINGS HAPPEN BETWEEN US AS 2644 01:59:05,054 --> 01:59:09,759 RESEARCHERS CREATING A CLINICAL 2645 01:59:09,759 --> 01:59:13,096 TRIAL IDEA AND PEOPLE AND 2646 01:59:13,096 --> 01:59:14,264 ENROLLING OR ARE GETTING TO THE 2647 01:59:14,264 --> 01:59:16,166 END OF THE TRIAL AND I LIKE TO 2648 01:59:16,166 --> 01:59:17,333 PAY ATTENTION TO CLINICAL TRIAL 2649 01:59:17,333 --> 01:59:17,700 CHARACTERISTICS. 2650 01:59:17,700 --> 01:59:20,103 THE DECISIONS WE MAKE OFTEN AS 2651 01:59:20,103 --> 01:59:23,373 STUDY TEAMS IN TERMS OF THE 2652 01:59:23,373 --> 01:59:24,874 INTERVENTION AND HOW MANY 2653 01:59:24,874 --> 01:59:25,909 PROCEDURES AND THINGS LIKE 2654 01:59:25,909 --> 01:59:28,445 NUMBER OF STUDY VISITS AND 2655 01:59:28,445 --> 01:59:29,646 INCENTIVES, ALL THESE CLINICAL 2656 01:59:29,646 --> 01:59:33,049 TRIAL CHARACTERISTICS IMPACT 2657 01:59:33,049 --> 01:59:35,452 PEOPLE'S WILLINGNESS OR 2658 01:59:35,452 --> 01:59:37,720 AVAILABILITY OR ACCESS TO DO THE 2659 01:59:37,720 --> 01:59:39,622 THINGS WE'RE ASKING THEM TO DO 2660 01:59:39,622 --> 01:59:44,494 AND ALSO EYE LIKE TO HIGHLIGHT 2661 01:59:44,494 --> 01:59:47,063 THE COMMUNICATION THROUGHOUT THE 2662 01:59:47,063 --> 01:59:48,431 TRIAL IS IMPORTANT. 2663 01:59:48,431 --> 01:59:50,033 HOW TO REACH PEOPLE, WHOSE THE 2664 01:59:50,033 --> 01:59:53,636 AUDIENCE AND CONTEXT AND 2665 01:59:53,636 --> 01:59:55,205 MESSAGING AND AT THE END THE 2666 01:59:55,205 --> 01:59:57,040 THINGS WE THINK ABOUT AS 2667 01:59:57,040 --> 01:59:58,675 RESEARCHERS ARE DO PEOPLE 2668 01:59:58,675 --> 02:00:01,478 DECLINE OR ENROLL, HOW MUCH 2669 02:00:01,478 --> 02:00:02,679 RETENTION DID WE HAVE AND AS 2670 02:00:02,679 --> 02:00:05,048 SOMEONE WHO STUDIES MEDICAL 2671 02:00:05,048 --> 02:00:07,050 DECISION MAKING I'M OFTEN 2672 02:00:07,050 --> 02:00:08,685 INTERESTED IN DO PEOPLE HAVE 2673 02:00:08,685 --> 02:00:09,285 DECISIONAL REGRET. 2674 02:00:09,285 --> 02:00:14,524 SO IF YOU'RE IN A TRIAL AND 2675 02:00:14,524 --> 02:00:17,794 EVERYTHING WENT WELL, YOU'RE 2676 02:00:17,794 --> 02:00:19,162 PROBABLY OKAY. 2677 02:00:19,162 --> 02:00:20,763 IF THINGS DIDN'T GO SO WELL YOU 2678 02:00:20,763 --> 02:00:24,300 MAYBE HAVE REGRET BUT WITH A 2679 02:00:24,300 --> 02:00:26,369 WELL INFORMED CONSENT PROCESS 2680 02:00:26,369 --> 02:00:28,438 THINGS MAY NOT TO PERFECTLY WELL 2681 02:00:28,438 --> 02:00:29,072 BUT THE EXPECTATIONS SHOULD BE 2682 02:00:29,072 --> 02:00:33,042 PLANKED. 2683 02:00:33,042 --> 02:00:33,276 MANAGED. 2684 02:00:33,276 --> 02:00:37,046 AS PART OF THAT SAME PAPER THAT 2685 02:00:37,046 --> 02:00:41,384 I HAD PUBLISHED OF MY GENERAL 2686 02:00:41,384 --> 02:00:42,852 MODEL OF CLINICAL TRIAL 2687 02:00:42,852 --> 02:00:44,354 PARTICIPATE I ALSO PUTS FORTH 2688 02:00:44,354 --> 02:00:47,323 THE ASK APPROACH FOR ENHANCING 2689 02:00:47,323 --> 02:00:47,924 CLINICAL TRIAL PARTICIPATION. 2690 02:00:47,924 --> 02:00:51,027 AS SOME OF YOU KNOW, MORE 2691 02:00:51,027 --> 02:00:54,097 CONTEMPORARY RESEARCH HAS BEEN 2692 02:00:54,097 --> 02:00:55,899 SHOWING THAT PARTICULARLY FOR 2693 02:00:55,899 --> 02:00:59,602 MINORITIZED FROUP AND THE 2694 02:00:59,602 --> 02:01:02,338 NARRATIVE HAS BEEN PEOPLE ARE 2695 02:01:02,338 --> 02:01:06,943 AFRAID AND HAVE MISTRUST AND 2696 02:01:06,943 --> 02:01:08,211 THERE'S THAT COMPONENT BUT 2697 02:01:08,211 --> 02:01:10,446 PEOPLE ARE OFTEN LITERALLY NOT 2698 02:01:10,446 --> 02:01:12,515 ASKED TO PARTICIPATE OR GIVEN 2699 02:01:12,515 --> 02:01:14,284 THE OPPORTUNITY. 2700 02:01:14,284 --> 02:01:15,585 A STANDS FOR ASSUME ALL PATIENTS 2701 02:01:15,585 --> 02:01:17,587 WANT TO KNOW THEIR OPENINGS EVEN 2702 02:01:17,587 --> 02:01:20,290 IF ONE IS A CLINICAL TRIAL AND 2703 02:01:20,290 --> 02:01:21,591 WE CAN HAVE FAITH THEY'RE ABLE 2704 02:01:21,591 --> 02:01:27,030 TO MAKE A DECISION ABOUT THEIR 2705 02:01:27,030 --> 02:01:27,997 OWN HEALTH CARE PLAN INCLUDING 2706 02:01:27,997 --> 02:01:29,132 POTENTIALLY OPTION OF A TRIAL. 2707 02:01:29,132 --> 02:01:34,537 WE ALSO WANT TO SEEK THE COUNCIL 2708 02:01:34,537 --> 02:01:44,948 OF STAKEHOLDERS AND K STANDS FOR 2709 02:01:44,948 --> 02:01:50,420 KNOW YOUR NUMBERS AND GET YOUR 2710 02:01:50,420 --> 02:01:54,190 GENERAL CHECK UP AND IN A STUDY 2711 02:01:54,190 --> 02:01:55,792 AND WHAT IS YOUR THEORETICAL 2712 02:01:55,792 --> 02:02:01,998 PULL SO IF YOU WORK WITH A BIO 2713 02:02:01,998 --> 02:02:08,237 STATISTICIAN AND THEY SAY IF 2714 02:02:08,237 --> 02:02:12,742 THEY LIVE IN BETHESDA, MARYLAND 2715 02:02:12,742 --> 02:02:13,910 AND HAVE SEEN 50 PEOPLE IN THE 2716 02:02:13,910 --> 02:02:15,812 LAST THREE YEARS YOU'LL HAVE A 2717 02:02:15,812 --> 02:02:17,480 PROBLEM BEFORE YOU START BECAUSE 2718 02:02:17,480 --> 02:02:19,582 YOU DIDN'T REALLY THINK ABOUT 2719 02:02:19,582 --> 02:02:24,887 WHAT YOUR THEORETICAL POOL OF 2720 02:02:24,887 --> 02:02:34,130 PEOPLE IS GOING TO BE. 2721 02:02:34,130 --> 02:02:36,132 CLEARLY YOU NEED TO HAVE A 2722 02:02:36,132 --> 02:02:37,333 SAMPLE SIZE OF WHAT YOU BELIEVE 2723 02:02:37,333 --> 02:02:38,868 IS SUFFICIENT. 2724 02:02:38,868 --> 02:02:40,870 STAKEHOLDERS ANY INCLUDE BUT NOT 2725 02:02:40,870 --> 02:02:42,772 LIMITED TO ALL OF THESE BULLET 2726 02:02:42,772 --> 02:02:43,039 POINTS. 2727 02:02:43,039 --> 02:02:48,511 EACH TIME I GIVE THIS TALK 2728 02:02:48,511 --> 02:02:49,579 SOMEONE COMES UP WITH ANOTHER 2729 02:02:49,579 --> 02:02:51,414 STAKEHOLDER GROUP I SHOULD THINK 2730 02:02:51,414 --> 02:02:55,985 OF BUT ONE OF THE LAST TALKS I 2731 02:02:55,985 --> 02:02:57,620 GAVE ONE OF MY COMMUNITY 2732 02:02:57,620 --> 02:02:58,688 PARTNERS SAID I SHOULD INCLUDE 2733 02:02:58,688 --> 02:02:59,756 COMMUNITIES HEALTH WORKERS. 2734 02:02:59,756 --> 02:03:00,790 DEPENDING ON YOUR RESEARCH 2735 02:03:00,790 --> 02:03:03,026 STUDY, YOU PLAY NOT NEED TO 2736 02:03:03,026 --> 02:03:04,961 INCLUDE ALL THESE PEOPLE BUT I 2737 02:03:04,961 --> 02:03:07,597 WOULD INVOLVED WITH A LOT OF 2738 02:03:07,597 --> 02:03:09,632 CONSULTATIONS, PARTICULARLY FOR 2739 02:03:09,632 --> 02:03:10,299 SOME OF THE COVID CLINICAL 2740 02:03:10,299 --> 02:03:13,903 TRIALS AND IN ADDITION TO 2741 02:03:13,903 --> 02:03:15,571 PATIENTS AND RESEARCHERS, WE 2742 02:03:15,571 --> 02:03:17,607 WORKED A LOT WITH OUR 2743 02:03:17,607 --> 02:03:19,575 COMMUNICATIONS AND MARKETING 2744 02:03:19,575 --> 02:03:22,278 FOLKS BECAUSE WE DID A LOT OF 2745 02:03:22,278 --> 02:03:24,514 PUBLIC ADVERTISEMENT. 2746 02:03:24,514 --> 02:03:28,785 IF YOU'RE GOING TO BE QUERYING 2747 02:03:28,785 --> 02:03:30,219 YOUR ELECTRONIC HEALTH RECORD 2748 02:03:30,219 --> 02:03:33,890 YOU NEED TO CONNECT WITH HEALTH 2749 02:03:33,890 --> 02:03:35,625 PEOPLE AND ALMOST EVERYONE WILL 2750 02:03:35,625 --> 02:03:40,930 INTERACT WITH THE IRB BUT SOME 2751 02:03:40,930 --> 02:03:43,032 IRBs -- SOME OF MY COLLEAGUES IN 2752 02:03:43,032 --> 02:03:44,667 THE LAST FIVE TO 10 YEARS HAVE 2753 02:03:44,667 --> 02:03:46,002 BEEN SPECIFICALLY WORKING WITH 2754 02:03:46,002 --> 02:03:51,040 IRBs TO EXPAND THEIR KNOWLEDGE 2755 02:03:51,040 --> 02:03:52,375 OF DOING COMMUNITY-BASED 2756 02:03:52,375 --> 02:03:54,377 RESEARCH AND SOME STRATEGIES ARE 2757 02:03:54,377 --> 02:03:55,511 DIFFERENT THAN THE MORE CLEAN 2758 02:03:55,511 --> 02:03:57,480 CUT DOING DRUG TRIALS. 2759 02:03:57,480 --> 02:03:59,816 DEPENDING ON WHAT YOU WANT TO DO 2760 02:03:59,816 --> 02:04:01,050 AND IF YOU'RE USING NOVEL 2761 02:04:01,050 --> 02:04:02,785 METHODS OF RECRUITMENT AND 2762 02:04:02,785 --> 02:04:04,387 RETENTION YOU MAY NEED TO GO 2763 02:04:04,387 --> 02:04:04,987 BACK AND FORTH WITH YOUR IRB 2764 02:04:04,987 --> 02:04:11,394 TEAM. 2765 02:04:11,394 --> 02:04:14,397 THIS CONCENTRIC CIRCLE MODEL IS 2766 02:04:14,397 --> 02:04:19,469 FROM WCG CLINICAL DOT -COM. 2767 02:04:19,469 --> 02:04:21,204 THE IDEA IS MOST THE TIME 2768 02:04:21,204 --> 02:04:22,972 ESPECIALLY WORKING IN A HEALTH 2769 02:04:22,972 --> 02:04:25,808 CARE SETTING THE INNER CIRCLE 2770 02:04:25,808 --> 02:04:27,577 AND PATIENTS CLOSEST TO WHERE 2771 02:04:27,577 --> 02:04:30,146 YOU ARE AND HAVE A RELATIONSHIP 2772 02:04:30,146 --> 02:04:33,015 WITH YOU OR HEALTH CARE AGENCY 2773 02:04:33,015 --> 02:04:34,717 OR GROUP, YOU ARE TYPICALLY 2774 02:04:34,717 --> 02:04:36,285 GOING TO HAVE MAYBE NOT AN EASY 2775 02:04:36,285 --> 02:04:39,589 TIME BUT YOU MAY HAVE BETTER 2776 02:04:39,589 --> 02:04:42,024 ACCESS AND A BETTER OPTION OF 2777 02:04:42,024 --> 02:04:43,593 CONNECTING AN OFFERING TRIALS TO 2778 02:04:43,593 --> 02:04:45,027 PATIENTS THAN MAYBE STARTING 2779 02:04:45,027 --> 02:04:50,967 WITH LIKE A MASS MEDIA CAMPAIGN. 2780 02:04:50,967 --> 02:04:52,335 I'M AT WAYNE STATE IN DETROIT. 2781 02:04:52,335 --> 02:04:55,004 I USED TO BE AT NYU HEALTH 2782 02:04:55,004 --> 02:04:58,174 SYSTEM IN NEW YORK AND 2783 02:04:58,174 --> 02:05:01,511 ESPECIALLY FOR COVID FOR A LOT 2784 02:05:01,511 --> 02:05:03,579 OF THE TRIALS RESEARCHERS WANTED 2785 02:05:03,579 --> 02:05:05,381 ADVERTISEMENTS IN THE SUBWAYS OR 2786 02:05:05,381 --> 02:05:05,915 BILLBOARDS. 2787 02:05:05,915 --> 02:05:06,916 WELL, NOT A LOT OF PEOPLE WERE 2788 02:05:06,916 --> 02:05:08,818 RIDING THE SUBWAYS DURING COVID 2789 02:05:08,818 --> 02:05:11,354 BUT THAT'S REALLY EXPENSIVE. 2790 02:05:11,354 --> 02:05:13,756 AND HOW MANY HAVE BEEN ON THE 2791 02:05:13,756 --> 02:05:16,325 METRO HERE IN THE D.C. AREA AND 2792 02:05:16,325 --> 02:05:20,496 SAW AN ADVERTISEMENT FOR A 2793 02:05:20,496 --> 02:05:23,466 CLINICAL TRIAL AND CALLED AND 2794 02:05:23,466 --> 02:05:23,966 ENROLLED? 2795 02:05:23,966 --> 02:05:25,368 I'M NOT SAYING IT'S NOT 2796 02:05:25,368 --> 02:05:27,036 IMPOSSIBLE BUT YOU DON'T WANT TO 2797 02:05:27,036 --> 02:05:30,173 DO THE BIGGEST, MOST EXPENSIVE 2798 02:05:30,173 --> 02:05:32,041 THING FIRST SO HERE ACTIVE 2799 02:05:32,041 --> 02:05:34,243 CLINIC PATIENTS EVEN INACTIVE 2800 02:05:34,243 --> 02:05:38,881 CLINIC PATIENTS. 2801 02:05:38,881 --> 02:05:40,817 THINK IF YOU'RE AT THE NIH 2802 02:05:40,817 --> 02:05:41,818 CLINICAL CENTER. 2803 02:05:41,818 --> 02:05:45,955 MAYBE PEOPLE WHO LAD A HISTORY 2804 02:05:45,955 --> 02:05:50,927 IN THE PAST MAY BE MORE OPEN TO 2805 02:05:50,927 --> 02:05:53,362 OPPORTUNITIES AND REFERRING 2806 02:05:53,362 --> 02:05:54,797 CLINICIANS AND PATIENTS AND 2807 02:05:54,797 --> 02:05:56,566 COMMUNITY OUTREACH WAS IMPORTANT 2808 02:05:56,566 --> 02:05:58,401 AND I'M NOT SAYING MEDIA 2809 02:05:58,401 --> 02:05:59,435 OUTREACH NEVER WORKS BUT YOU 2810 02:05:59,435 --> 02:06:01,971 DON'T WANT TO DO THE MOST 2811 02:06:01,971 --> 02:06:02,672 EXPENSIVE THING FOR PEOPLE IN 2812 02:06:02,672 --> 02:06:07,577 THE WORLD WHO HAVE NO IDEA WHO 2813 02:06:07,577 --> 02:06:15,184 YOU ARE AND THE RELATIONSHIP. 2814 02:06:15,184 --> 02:06:16,686 AND MAY INCLUDE SOCIAL MEDIA ARE 2815 02:06:16,686 --> 02:06:21,023 OTHER STRATEGIES, E-MAIL, 2816 02:06:21,023 --> 02:06:22,658 E.H.R.-RECORDS BASED METHODS. 2817 02:06:22,658 --> 02:06:23,926 I'VE USED THAT AT SOME OF MY 2818 02:06:23,926 --> 02:06:25,962 PRIOR INSTITUTIONS. 2819 02:06:25,962 --> 02:06:30,233 THEY HAVE EPIC AND MY CHART AND 2820 02:06:30,233 --> 02:06:36,973 WITHIN EPIC THE HEALTH I.T. TEAM 2821 02:06:36,973 --> 02:06:40,343 CAN ACTIVATE THE RESEARCH AND 2822 02:06:40,343 --> 02:06:43,579 WITH IB APPROVAL AND IN 2823 02:06:43,579 --> 02:06:45,481 PARTNERSHIP WITH YOUR I.T. TEAM 2824 02:06:45,481 --> 02:06:48,050 CAN PUSH OUT DIRECT TO PATIENT 2825 02:06:48,050 --> 02:06:50,052 INVITATIONS VIA THE PORTAL AND 2826 02:06:50,052 --> 02:06:51,120 IF PATIENTS ARE INTERESTED THE 2827 02:06:51,120 --> 02:06:52,655 CAN CLICK YES, I'M INTERESTED. 2828 02:06:52,655 --> 02:06:59,595 ONCE THE PEOPLE IDENTIFIED AS 2829 02:06:59,595 --> 02:07:02,498 INTERESTED ARE ABLE TO RESPOND 2830 02:07:02,498 --> 02:07:04,834 VIA THE PATIENT PORTAL WITH THE 2831 02:07:04,834 --> 02:07:06,602 INTERESTED PATIENT. 2832 02:07:06,602 --> 02:07:13,476 I'VE DONE RESEARCH WITH ONLINE 2833 02:07:13,476 --> 02:07:17,914 SURVEY PANELS THOSE WORK BETTER 2834 02:07:17,914 --> 02:07:19,482 FOR MORE SURVEY RESEARCH BROADER 2835 02:07:19,482 --> 02:07:24,754 THINGS BUT IT IS AN OPTION. 2836 02:07:24,754 --> 02:07:26,022 YOU CAN DO PAID DIGITAL 2837 02:07:26,022 --> 02:07:29,091 ADVERTISEMENT AND POSTING ON YEB 2838 02:07:29,091 --> 02:07:29,292 SIGHT. 2839 02:07:29,292 --> 02:07:32,028 SOMETIMES PEOPLE WILL HEAR ABOUT 2840 02:07:32,028 --> 02:07:33,496 SOMETHING AND FORWARD IT TO 2841 02:07:33,496 --> 02:07:34,096 THEIR FRIENDS. 2842 02:07:34,096 --> 02:07:35,898 SOME RESEARCH PROJECTS I'M AWARE 2843 02:07:35,898 --> 02:07:37,600 OF THAT HAVEN'T BEEN DIRECTLY 2844 02:07:37,600 --> 02:07:42,905 INVOLVED IN HAVE GOTTEN 2845 02:07:42,905 --> 02:07:45,341 PERMISSION THROUGH THEIR IRB 2846 02:07:45,341 --> 02:07:47,343 PROTOCOL TO TEXT PATIENTS TO 2847 02:07:47,343 --> 02:07:48,411 CONSIDER PARTICIPATING IN A 2848 02:07:48,411 --> 02:07:51,580 RESEARCH TRIAL WHICH ALSO HAS 2849 02:07:51,580 --> 02:07:52,181 IMPLICATIONS FOR SUBJECT 2850 02:07:52,181 --> 02:07:53,082 SELECTION AND WHEN YOU THINK 2851 02:07:53,082 --> 02:07:54,550 ABOUT NOWADAYS A LOT OF PEOPLE 2852 02:07:54,550 --> 02:07:56,585 DO USE E-MAIL BUT A LOT OF 2853 02:07:56,585 --> 02:07:58,354 PEOPLE ARE VERY DEPENDENT ON 2854 02:07:58,354 --> 02:07:59,855 THEIR CELL PHONES AND TEXT 2855 02:07:59,855 --> 02:08:00,156 MESSAGING. 2856 02:08:00,156 --> 02:08:02,158 SO IF THAT'S A GOOD WAY TO REACH 2857 02:08:02,158 --> 02:08:03,225 YOUR AUDIENCE, YOU MAY WANT TO 2858 02:08:03,225 --> 02:08:07,496 CONSIDER THAT. 2859 02:08:07,496 --> 02:08:10,099 AND YOU MY WANT TO CONSIDER 2860 02:08:10,099 --> 02:08:12,802 RECRUITMENT REGISTRIES SUCH AS 2861 02:08:12,802 --> 02:08:14,904 RESEARCH MATCH DOT ORG. 2862 02:08:14,904 --> 02:08:16,138 HAS ANYONE EVER HEARD OF 2863 02:08:16,138 --> 02:08:19,575 RESEARCH MATCH DOT ORG OR USED 2864 02:08:19,575 --> 02:08:27,283 IT? 2865 02:08:27,283 --> 02:08:29,652 IT'S A PROGRAM FUNDED BY NIH AND 2866 02:08:29,652 --> 02:08:30,953 IT'S A NATIONAL REGISTRY THOUGH 2867 02:08:30,953 --> 02:08:33,022 PEOPLE DON'T HAVE TO PROACTIVELY 2868 02:08:33,022 --> 02:08:37,126 JOIN THE REGISTRY TO FIND 2869 02:08:37,126 --> 02:08:39,028 RESEARCH OPPORTUNITIES. 2870 02:08:39,028 --> 02:08:41,931 I ACTUALLY JOINED RESEARCH MATCH 2871 02:08:41,931 --> 02:08:44,166 DOT ORG YEARS AGO BECAUSE I WAS 2872 02:08:44,166 --> 02:08:45,167 CURIOUS HOW IT WORKED BUT 2873 02:08:45,167 --> 02:08:46,268 BECAUSE I'M A REGISTERED 2874 02:08:46,268 --> 02:08:49,138 PARTICIPANT I GET ALERTS EVERY 2875 02:08:49,138 --> 02:08:55,244 SO OFTEN ABOUT UNIVERSITY OF SAN 2876 02:08:55,244 --> 02:09:00,116 FRANCISCO HAS THIS STUDY ON X, 2877 02:09:00,116 --> 02:09:00,483 Y, Z. 2878 02:09:00,483 --> 02:09:01,817 BECAUSE IT'S A NATIONAL REGISTRY 2879 02:09:01,817 --> 02:09:03,719 YOU MAY GET INVITATIONS IF YOU 2880 02:09:03,719 --> 02:09:04,787 SIGN UP FROM UNIVERSITIES FROM 2881 02:09:04,787 --> 02:09:08,090 ACROSS THE COUNTRY. 2882 02:09:08,090 --> 02:09:14,196 AS OF TWO DAYS AGO THERE'S ABOUT 2883 02:09:14,196 --> 02:09:16,098 120,000 PEOPLE WHO REGISTERED ON 2884 02:09:16,098 --> 02:09:18,067 RESEARCH MATCH AND IT'S GROWING. 2885 02:09:18,067 --> 02:09:21,037 I THINK THERE'S 1500 ACADEMIC 2886 02:09:21,037 --> 02:09:28,978 MEDICAL CENTERS PART OF IT. 2887 02:09:28,978 --> 02:09:32,014 IT'S FAIRLY SIMPLE TO REGISTER 2888 02:09:32,014 --> 02:09:38,287 AND RESEARCH MATCH.org AND FOR 2889 02:09:38,287 --> 02:09:41,190 SURVEY RESEARCH AND WHERE PEOPLE 2890 02:09:41,190 --> 02:09:42,324 DON'T NEED TO NECESSARILY COME 2891 02:09:42,324 --> 02:09:44,226 INTO THE CLINICAL CENTER IT 2892 02:09:44,226 --> 02:09:45,027 COULD BE A GOOD RESOURCE TO 2893 02:09:45,027 --> 02:09:50,366 CONSIDER. 2894 02:09:50,366 --> 02:09:52,768 I WANT TO GIVE A FEW EXAMPLES. 2895 02:09:52,768 --> 02:09:57,506 I HAVE MORE RECENTLY WITHIN THE 2896 02:09:57,506 --> 02:09:59,708 LAST EIGHT YEARS BEEN DOING MORE 2897 02:09:59,708 --> 02:10:01,610 RESEARCH ON HYPERTENSION 2898 02:10:01,610 --> 02:10:02,211 MANAGEMENT AND CARDIOVASCULAR 2899 02:10:02,211 --> 02:10:03,946 DISEASE IN BLACK ADULTS. 2900 02:10:03,946 --> 02:10:06,482 HISTORICALLY MY EARLIER RESEARCH 2901 02:10:06,482 --> 02:10:07,716 WAS ON CLINICAL TRIAL 2902 02:10:07,716 --> 02:10:08,984 PARTICIPATION OF UNDER 2903 02:10:08,984 --> 02:10:09,652 REPRESENTED GROUPS. 2904 02:10:09,652 --> 02:10:11,587 FOR MY CAREER DEVELOPMENT AWARD 2905 02:10:11,587 --> 02:10:15,224 WHEN I WAS IN NEW YORK, I DID 2906 02:10:15,224 --> 02:10:17,226 FOCUS GROUPS WITH BLACK PATIENTS 2907 02:10:17,226 --> 02:10:18,761 AND MY PRIMARY STRATEGY FOR 2908 02:10:18,761 --> 02:10:21,997 RECRUITING PATIENTS WAS ACTUALLY 2909 02:10:21,997 --> 02:10:24,333 GOING THROUGH OUR HEALTH SYSTEM 2910 02:10:24,333 --> 02:10:25,901 ELECTRONIC MEDICAL RECORD AND 2911 02:10:25,901 --> 02:10:26,769 INVITING PEOPLE THROUGH THE 2912 02:10:26,769 --> 02:10:29,105 PATIENT PORTAL SO I ONLY NEEDED 2913 02:10:29,105 --> 02:10:39,482 40 PEOPLE BUT GOT 500. 2914 02:10:40,850 --> 02:10:44,420 I THINK MY DESCRIPTION WAS NOT 2915 02:10:44,420 --> 02:10:51,026 OVERLY WORDY AND GOT A QUICK 2916 02:10:51,026 --> 02:10:57,867 RESPONSE AND I DID INVITE PEOPLE 2917 02:10:57,867 --> 02:10:59,735 THROUGH THE PATIENT PORTAL FOR 2918 02:10:59,735 --> 02:11:01,003 THE FOCUS GROUPS. 2919 02:11:01,003 --> 02:11:04,907 I ALSO DID A SURVEY OF 200 BLACK 2920 02:11:04,907 --> 02:11:08,310 ADULTS WITH HYPERTENSION AND 2921 02:11:08,310 --> 02:11:11,380 WENT THROUGH OUR PATIENT PORTAL 2922 02:11:11,380 --> 02:11:13,682 AND UTILIZED RESEARCH MATCH.org 2923 02:11:13,682 --> 02:11:15,151 FOR THE BROADER SURVEY AND 2924 02:11:15,151 --> 02:11:16,652 WORKED WITH OUR I.T. PEOPLE 2925 02:11:16,652 --> 02:11:19,488 BECAUSE FOR THAT STUDY I ALSO 2926 02:11:19,488 --> 02:11:22,625 RECRUITED CLINICIANS. 2927 02:11:22,625 --> 02:11:25,494 THEY WERE ABLE TO HELP ME QUERY 2928 02:11:25,494 --> 02:11:28,230 PRIMARY CLAIR CLINICIANS WITHIN 2929 02:11:28,230 --> 02:11:29,798 OUR HEALTH SYSTEM AND THERE'S 2930 02:11:29,798 --> 02:11:32,168 ALL THESE CATEGORIES OF HOW 2931 02:11:32,168 --> 02:11:36,405 DOCTORS ARE LABELLED I GUESS 2932 02:11:36,405 --> 02:11:38,541 WITHIN THE HEALTH SYSTEM. 2933 02:11:38,541 --> 02:11:40,442 THEY MAY BE IN FAMILY MEDICINE 2934 02:11:40,442 --> 02:11:42,411 AND SOME ARE IN DIFFERENT GROUPS 2935 02:11:42,411 --> 02:11:45,481 THOUGH THEY SEE PATIENTS WITH 2936 02:11:45,481 --> 02:11:48,617 HYPERTENSION AND A WAY TO 2937 02:11:48,617 --> 02:11:49,718 POTENTIALLY IDENTIFY POSITIONS. 2938 02:11:49,718 --> 02:11:53,822 I PUT IN A GRANT APPLICATION A 2939 02:11:53,822 --> 02:11:55,591 COUPLE WEEKS AGO TO NHLBI WHERE 2940 02:11:55,591 --> 02:11:58,961 I'LL BE RECRUITING BLACK 2941 02:11:58,961 --> 02:12:00,629 PATIENTS IN THE DETROIT AREA 2942 02:12:00,629 --> 02:12:02,264 WITH HYPERTENSION BUT FOCUSSING 2943 02:12:02,264 --> 02:12:04,166 ON FEDERALLY QUALIFIED HEALTH 2944 02:12:04,166 --> 02:12:04,400 CENTERS. 2945 02:12:04,400 --> 02:12:07,169 SO WAYNE STREET DOES NOT HAVE 2946 02:12:07,169 --> 02:12:11,574 IT'S NOT CONNECTS TO A HEALTH 2947 02:12:11,574 --> 02:12:12,508 SYSTEM PER SE. 2948 02:12:12,508 --> 02:12:15,578 I'M WORKING I'LL BE WORKING WITH 2949 02:12:15,578 --> 02:12:16,679 AN INDEPENDENT FEDERALLY 2950 02:12:16,679 --> 02:12:18,047 QUALIFIED HEALTH CENTER AND THE 2951 02:12:18,047 --> 02:12:19,014 CLINICAL DIRECTOR I TALK TO 2952 02:12:19,014 --> 02:12:20,316 SEVERAL TIMES AND I SAY IS THERE 2953 02:12:20,316 --> 02:12:22,685 A WAY FOR ME TO WORK WITH YOUR 2954 02:12:22,685 --> 02:12:24,019 I.T. PERSON AND GET A LIST. 2955 02:12:24,019 --> 02:12:27,056 THEY SAID WE'RE NOT GIVING A 2956 02:12:27,056 --> 02:12:29,858 LIST OF OUR PATIENTS BUT BUT IF 2957 02:12:29,858 --> 02:12:31,026 THEY'RE OWN COLLISIONS BRING UP 2958 02:12:31,026 --> 02:12:33,028 TRIALS TO THEIR PATIENTS BECAUSE 2959 02:12:33,028 --> 02:12:37,299 IT'S A MEDICALLY UNDER SERVED 2960 02:12:37,299 --> 02:12:38,434 GROUP THEY TRUST THE DOCTORS SO 2961 02:12:38,434 --> 02:12:39,802 IF YOU GET FUNDED THE CLINICIANS 2962 02:12:39,802 --> 02:12:42,404 WILL BRING UP THE STUDY AND DO A 2963 02:12:42,404 --> 02:12:45,074 SOFT HAND OFF IF PATIENTS ARE 2964 02:12:45,074 --> 02:12:47,576 INTERESTED. 2965 02:12:47,576 --> 02:12:51,413 HE SUGGESTED I CREATE LIKE 3X5 2966 02:12:51,413 --> 02:12:53,816 CARDS AND PLAIN LANGUAGE OF THE 2967 02:12:53,816 --> 02:12:54,750 STUDY AND IF PATIENTS ARE 2968 02:12:54,750 --> 02:12:55,918 INTERESTED THEY'LL HAVE TO 2969 02:12:55,918 --> 02:12:57,052 CONTACT US. 2970 02:12:57,052 --> 02:13:01,090 YOU HAVE TO WORK WITH WHATEVER 2971 02:13:01,090 --> 02:13:02,024 GROUP YOU'RE WORKING WITH AND 2972 02:13:02,024 --> 02:13:05,427 SOMETIMES THE METHODOLOGY WILL 2973 02:13:05,427 --> 02:13:06,295 BE DEPENDENT ON WHO YOU ARE AND 2974 02:13:06,295 --> 02:13:07,997 WHO YOU WANT TO WORK WITH AND 2975 02:13:07,997 --> 02:13:11,400 COMFORT WITH DIFFERENT 2976 02:13:11,400 --> 02:13:11,900 METHODOLOGIES. 2977 02:13:11,900 --> 02:13:13,068 WE'LL SEE HOW THAT GOES. 2978 02:13:13,068 --> 02:13:15,437 NOW I WANT TO TALK A LITTLE BIT 2979 02:13:15,437 --> 02:13:20,476 ABOUT SOME HEALTH LITERACY 2980 02:13:20,476 --> 02:13:21,043 CONSIDERATIONS. 2981 02:13:21,043 --> 02:13:23,012 BOTH FOR CLINICAL TRIAL 2982 02:13:23,012 --> 02:13:23,612 COMMUNICATIONS AND INFORMED 2983 02:13:23,612 --> 02:13:25,481 CONSENT. 2984 02:13:25,481 --> 02:13:26,248 THROUGH THE YEARS THERE'S BEEN 2985 02:13:26,248 --> 02:13:28,784 DIFFERENT DEFINITIONS OF HEALTH 2986 02:13:28,784 --> 02:13:29,051 LITERACY. 2987 02:13:29,051 --> 02:13:30,819 I'M USING ONE FROM HEALTHY 2988 02:13:30,819 --> 02:13:35,491 PEOPLE 2030 AND THEY DEFINE 2989 02:13:35,491 --> 02:13:36,325 PERSONAL HEALTH LITERACY AS TO 2990 02:13:36,325 --> 02:13:37,660 THE DEGREE INDIVIDUALS HAVE THE 2991 02:13:37,660 --> 02:13:41,764 ABILITY TO FIND, UNDERSTAND AND 2992 02:13:41,764 --> 02:13:43,098 USE INFORMATION IN SERVICES TO 2993 02:13:43,098 --> 02:13:45,034 INFORM HEALTH-RELATED DECISIONS 2994 02:13:45,034 --> 02:13:48,437 AND ACTIONS FOR THEMSELVES AND 2995 02:13:48,437 --> 02:13:48,804 OTHERS. 2996 02:13:48,804 --> 02:13:50,306 WHEN YOU THINK OF THAT WITH OUR 2997 02:13:50,306 --> 02:13:53,509 CASE WITH LINDA EARLIER WITH 2998 02:13:53,509 --> 02:13:57,046 TYPE II TRYING TO FIND A TRIAL 2999 02:13:57,046 --> 02:14:01,984 FOR TYPE II DIABETES, PEOPLE 3000 02:14:01,984 --> 02:14:03,786 DIFFER WHERE THEY WOULD FIND IT 3001 02:14:03,786 --> 02:14:04,687 AND UNDERSTAND AND WHETHER THEY 3002 02:14:04,687 --> 02:14:10,826 PREFER PRINT OR AUDIO OR MORE 3003 02:14:10,826 --> 02:14:21,337 VISUAL INFORMATION THESE ARE 3004 02:14:23,038 --> 02:14:24,073 LOOKING AT THE ASSOCIATION AND 3005 02:14:24,073 --> 02:14:28,143 THIS WAS A QUALITATIVE STUDY OF 3006 02:14:28,143 --> 02:14:32,848 20 WOMEN WITH LOWER HEALTH 3007 02:14:32,848 --> 02:14:34,717 LITERACY WHO PARTICIPATED IN A 3008 02:14:34,717 --> 02:14:38,153 PHASE 2 TRIAL FOR BREAST CANCER 3009 02:14:38,153 --> 02:14:41,924 AND WHAT THEY ARE FOUND WAS 3010 02:14:41,924 --> 02:14:43,192 WOMEN WITH LOWER LITERACY WERE 3011 02:14:43,192 --> 02:14:47,062 LESS LIKELY TO RELY ON PROVIDE 3012 02:14:47,062 --> 02:14:47,896 RECOMMENDATION WHETHER THEY 3013 02:14:47,896 --> 02:14:49,465 SHOULD ENROLL IN A TRIAL WHICH 3014 02:14:49,465 --> 02:14:50,733 IS PROBABLY NOT THAT SURPRISING. 3015 02:14:50,733 --> 02:14:55,471 SO IF YOU HAVE TROUBLE WITH 3016 02:14:55,471 --> 02:14:57,806 HEALTH LITERACY YOU MAY RELY ON 3017 02:14:57,806 --> 02:15:00,008 OUR CLINICAL TEAM TO ADVISE YOU 3018 02:15:00,008 --> 02:15:05,581 TO CONSIDER IT OR NOT. 3019 02:15:05,581 --> 02:15:16,091 AND THIS AND THE STUDY OF 500 3020 02:15:17,259 --> 02:15:21,029 PATIENT GOT INFORMATION ABOUT 3021 02:15:21,029 --> 02:15:25,467 RANDOMIZATION IN PLAIN LANGUAGE 3022 02:15:25,467 --> 02:15:29,471 OR GIVEN A GAMBLING METAPHOR AND 3023 02:15:29,471 --> 02:15:30,205 BENIGN METAPHOR WHERE THEY 3024 02:15:30,205 --> 02:15:31,607 DESCRIBED RANDOMIZATION AS THE 3025 02:15:31,607 --> 02:15:33,409 CHANCE OF A PREGNANT WOMAN 3026 02:15:33,409 --> 02:15:38,547 HAVING A MALE OR FEMALE CHILD 3027 02:15:38,547 --> 02:15:42,217 AND AND CONTROLLED CONTINUE AND 3028 02:15:42,217 --> 02:15:44,353 PEOPLE WITH HIGHER HEALTH 3029 02:15:44,353 --> 02:15:47,356 LITERACY PREFERRED OR DID BETTER 3030 02:15:47,356 --> 02:15:48,023 UNDERSTANDING RANDOMIZATION WITH 3031 02:15:48,023 --> 02:15:49,491 THE GAMBLING METAPHOR. 3032 02:15:49,491 --> 02:15:52,294 AGAIN THE FLIP OF A COIN. 3033 02:15:52,294 --> 02:15:57,032 PEOPLE WITH LOWER LITERACY 3034 02:15:57,032 --> 02:16:00,302 SKILLS WERE UNDERSTOOD 3035 02:16:00,302 --> 02:16:01,670 RANDOMIZATION BETTER WHEN IT WAS 3036 02:16:01,670 --> 02:16:03,505 THE CHANCE OF A MALE OR FEMALE 3037 02:16:03,505 --> 02:16:04,339 CHILD. 3038 02:16:04,339 --> 02:16:07,309 INTERESTING STUDIES AND THINGS 3039 02:16:07,309 --> 02:16:09,011 TO CONSIDER. 3040 02:16:09,011 --> 02:16:14,249 FINALLY IN THE LAST STUDY BY KIM 3041 02:16:14,249 --> 02:16:16,685 AND KIM THEY THIGH RANDOMIZED 3042 02:16:16,685 --> 02:16:20,522 150 PEOPLE TO GET TO WITH ONE OF 3043 02:16:20,522 --> 02:16:22,191 TWO CONDITIONS. 3044 02:16:22,191 --> 02:16:24,927 A STANDARD CONSENT FORM OR MORE 3045 02:16:24,927 --> 02:16:30,265 SIMPLIFIED VERSION OF A CONSENT 3046 02:16:30,265 --> 02:16:36,939 FORM PEOPLE PREFER 3047 02:16:36,939 --> 02:16:37,873 SIMPLIFICATION AND THAT WAS 3048 02:16:37,873 --> 02:16:38,774 BETTER FOR EVERYBODY. 3049 02:16:38,774 --> 02:16:41,343 PROBABLY NOT A SURPRISING 3050 02:16:41,343 --> 02:16:43,178 FINDING IF YOU HAVE THE 3051 02:16:43,178 --> 02:16:44,012 OPPORTUNITY TO SIMPLIFY 3052 02:16:44,012 --> 02:16:46,281 INFORMATION IN A CONSENT FORM. 3053 02:16:46,281 --> 02:16:47,249 HAS ANYONE EVER BEEN IN A 3054 02:16:47,249 --> 02:16:48,050 CLINICAL TRIAL WHERE THEY HAD TO 3055 02:16:48,050 --> 02:16:53,121 READ A CONCEPT FORM? 3056 02:16:53,121 --> 02:16:54,490 -- CONSENT FORM? 3057 02:16:54,490 --> 02:16:56,458 OKAY, YOU HAVE AND I HAVE. 3058 02:16:56,458 --> 02:16:57,626 HOPEFULLY IT WAS STRAIGHTFORWARD 3059 02:16:57,626 --> 02:17:00,996 BUT SOMETIMES IT COULD BE 3060 02:17:00,996 --> 02:17:03,565 MULTIPLE PAGE AND SMALL FONT FOR 3061 02:17:03,565 --> 02:17:06,001 LEGAL AND ETHICAL REASONS AND 3062 02:17:06,001 --> 02:17:14,910 SOMETIMES CAN BE OVERWHELMING. 3063 02:17:14,910 --> 02:17:15,811 THIS PAPER I WORKED WITH 3064 02:17:15,811 --> 02:17:17,679 COLLEAGUES BROADLY IN THE 3065 02:17:17,679 --> 02:17:21,049 DECISION SCIENCE WORLD AND WE 3066 02:17:21,049 --> 02:17:23,585 PUBLISHED THIS PAPER DESCRIBING 3067 02:17:23,585 --> 02:17:26,355 A PROFESSION FOR DEVELOPING A 3068 02:17:26,355 --> 02:17:28,056 PLAIN LANGUAGE SUPPORT TOOL TO 3069 02:17:28,056 --> 02:17:29,424 HELP PEOPLE CONSIDER 3070 02:17:29,424 --> 02:17:30,893 PARTICIPATING IN CANCER CLINICAL 3071 02:17:30,893 --> 02:17:34,296 TRIALS AND WE LOOKED AT HEALTH 3072 02:17:34,296 --> 02:17:36,899 LITERACY AND BLENDING HEALTH 3073 02:17:36,899 --> 02:17:39,268 LITERACY, ACADEMIC RESEARCH AND 3074 02:17:39,268 --> 02:17:44,506 MINORITY PATIENT PERSPECTIVES. 3075 02:17:44,506 --> 02:17:48,343 THIS WAS A THREE-PHASE PROCESS 3076 02:17:48,343 --> 02:17:51,246 AND DID QUALITATIVE INTERVIEWS 3077 02:17:51,246 --> 02:17:53,048 WITH 45 BLACK AND HISPANIC 3078 02:17:53,048 --> 02:17:54,216 CANCER SURVIVORS TO UNDERSTAND 3079 02:17:54,216 --> 02:17:56,885 THEIR CHALLENGES AND I GUESS 3080 02:17:56,885 --> 02:17:58,186 OPPORTUNITIES RELATED TO 3081 02:17:58,186 --> 02:18:00,222 CLINICAL TRIALS. 3082 02:18:00,222 --> 02:18:04,660 THE SECOND PART WAS A SURVEY OF 3083 02:18:04,660 --> 02:18:05,827 1100 CANCER SURVIVORS AND THEN 3084 02:18:05,827 --> 02:18:09,531 LITERATURE REVIEW. 3085 02:18:09,531 --> 02:18:12,067 AND THEN PHASE II WAS CONSENT 3086 02:18:12,067 --> 02:18:13,602 GENERATION AND TAKING THE 3087 02:18:13,602 --> 02:18:15,337 INFORMATION LEARNED IN PHASE I 3088 02:18:15,337 --> 02:18:17,573 AND CREATE A FIRST PROTOTYPE OF 3089 02:18:17,573 --> 02:18:19,708 THE DECISION SUPPORT TOOL AND 3090 02:18:19,708 --> 02:18:21,877 PHASE III WAS USABILITY TESTING. 3091 02:18:21,877 --> 02:18:27,049 THIS PAPER DESCRIBES A PROCESS 3092 02:18:27,049 --> 02:18:28,650 FOR DEVELOPING A DECISION 3093 02:18:28,650 --> 02:18:29,785 SUPPORT TOOL. 3094 02:18:29,785 --> 02:18:34,690 AS PART OF THAT SAME PAPER, WE 3095 02:18:34,690 --> 02:18:36,758 PROPOSED OR TALKED ABOUT THE 3096 02:18:36,758 --> 02:18:38,160 MODEL FOR CANCER CLINICAL TRIAL 3097 02:18:38,160 --> 02:18:39,561 PARTICIPATION STANDING FOR 3098 02:18:39,561 --> 02:18:42,564 KNOWLEDGE, EMPOWERMENT AND 3099 02:18:42,564 --> 02:18:43,298 VALUES CLARIFICATION. 3100 02:18:43,298 --> 02:18:45,000 I WON'T GO OVER EVERY BOX 3101 02:18:45,000 --> 02:18:50,272 BECAUSE SOME WERE REPRESENTED IN 3102 02:18:50,272 --> 02:18:53,375 PAST MODELS BUT WITH DECISION 3103 02:18:53,375 --> 02:18:56,878 SUPPORT TOOLS, THE MIDDLE BOXES, 3104 02:18:56,878 --> 02:18:58,914 COMMUNICATION SKILLS DEVELOPMENT 3105 02:18:58,914 --> 02:19:01,783 AND COMMUNICATION IS AN 3106 02:19:01,783 --> 02:19:06,755 IMPORTANT PRINCIPLE IN DECISION 3107 02:19:06,755 --> 02:19:07,456 MAKING. 3108 02:19:07,456 --> 02:19:09,458 FOR DECISION MAKING AND THE 3109 02:19:09,458 --> 02:19:11,026 IDEAS OF VALUES CLARIFICATION 3110 02:19:11,026 --> 02:19:13,362 LIKE EXERCISES AND QUESTIONS TO 3111 02:19:13,362 --> 02:19:14,529 HELP PEOPLE THINK THROUGH WHAT 3112 02:19:14,529 --> 02:19:17,633 THEIR OWN PERSONAL VALUES ARE 3113 02:19:17,633 --> 02:19:19,201 AND WHAT THEY WOULD PERCEIVE AS 3114 02:19:19,201 --> 02:19:23,572 THE VALUE OF PARTICIPATING IN A 3115 02:19:23,572 --> 02:19:26,441 CANCER CLINICAL TRIAL. 3116 02:19:26,441 --> 02:19:30,812 NOW I WANT TO SHIFT TO BUILDING 3117 02:19:30,812 --> 02:19:32,748 AND MAINTAINING TRUST. 3118 02:19:32,748 --> 02:19:38,787 AND THIS IS A QUOTE FROM A PAPER 3119 02:19:38,787 --> 02:19:42,157 FROM MY COLLEAGUE DEREK GRIF 3120 02:19:42,157 --> 02:19:44,526 EDGE AN READ THIS OUTS, TRUST, 3121 02:19:44,526 --> 02:19:48,430 MISTRUST AND DISTRUST INFLUENCE 3122 02:19:48,430 --> 02:19:51,033 PEOPLE'S ABILITY TO UTILIZE 3123 02:19:51,033 --> 02:19:52,134 CRITICAL RESOURCES AND MAKE 3124 02:19:52,134 --> 02:19:52,868 DECISIONS BEST FOR THEIR HEALTH 3125 02:19:52,868 --> 02:19:53,635 AND WELL BEING. 3126 02:19:53,635 --> 02:19:55,404 TRUST IS NECESSARY FOR 3127 02:19:55,404 --> 02:19:57,039 OPTIMIZING HEALTH RESEARCH, 3128 02:19:57,039 --> 02:19:58,273 ELIMINATING HEALTH CARE 3129 02:19:58,273 --> 02:20:00,742 DISPARITIES AND ACHIEVING HEALTH 3130 02:20:00,742 --> 02:20:02,778 EQUITY BUT EFFORTS TO BUILD 3131 02:20:02,778 --> 02:20:05,380 TRUST TO INCREASE HEALTH CARE 3132 02:20:05,380 --> 02:20:07,416 UTILIZATION IN RESEARCH 3133 02:20:07,416 --> 02:20:09,785 PARTICIPATION MAY WILL LITTLE 3134 02:20:09,785 --> 02:20:11,086 EFFORT ON ATTITUDES AND 3135 02:20:11,086 --> 02:20:13,288 BEHAVIORS ROOTED IN DISTRUST AND 3136 02:20:13,288 --> 02:20:13,622 MISTRUST. 3137 02:20:13,622 --> 02:20:20,929 THIS PAPER IS NOT SUPER LONG BUT 3138 02:20:20,929 --> 02:20:23,565 THEY DO A GOOD JOB OF TALKING 3139 02:20:23,565 --> 02:20:24,700 ABOUT TRUST AND MISTRUST AND 3140 02:20:24,700 --> 02:20:27,135 SOMETIMES IN ACADEMIC SITUATIONS 3141 02:20:27,135 --> 02:20:30,405 LIKE THIS WE USE THE TERMS 3142 02:20:30,405 --> 02:20:33,775 INTERCHANGEABLY AND MISTRUST AND 3143 02:20:33,775 --> 02:20:35,844 DISTRUST AND BUILDING TRUST IN 3144 02:20:35,844 --> 02:20:37,779 PEOPLE WITH LOW TRUST THEY'RE 3145 02:20:37,779 --> 02:20:40,315 DISTINCT THINGS AND ARGUE IT'S 3146 02:20:40,315 --> 02:20:41,116 IMPORTANT WE'RE PRECISE IN WHAT 3147 02:20:41,116 --> 02:20:42,150 WE'RE TALKING ABOUT AND WHAT 3148 02:20:42,150 --> 02:20:49,424 WE'RE TRYING TO INTERVENE ON. 3149 02:20:49,424 --> 02:20:54,596 THIS IS A CONCEPTUAL MODEL FROM 3150 02:20:54,596 --> 02:21:05,040 A PAPER CONSUELA WILLIAMS 3151 02:21:10,746 --> 02:21:12,948 MENTIONED AND SHE POSITS THESE 3152 02:21:12,948 --> 02:21:15,317 ARE AREAS THAT ARE IMPORTANT. 3153 02:21:15,317 --> 02:21:18,820 NONE OF THESE SHOULD BE PRIZING 3154 02:21:18,820 --> 02:21:22,424 BUT I THINK IT'S GOOD TO RESIST 3155 02:21:22,424 --> 02:21:24,893 CONC 3156 02:21:24,893 --> 02:21:25,160 CONCEPTS. 3157 02:21:25,160 --> 02:21:26,762 TRUST IS IMPORTANT AND 3158 02:21:26,762 --> 02:21:27,629 COMMUNICATION AND CONFIDENCE. 3159 02:21:27,629 --> 02:21:29,531 THE BELIEF AND RELIABILITY OF 3160 02:21:29,531 --> 02:21:35,570 THE DIFFERENT PARTIES ENSURING 3161 02:21:35,570 --> 02:21:39,207 PEOPLE HAVE CONFIDENTIALITY AND 3162 02:21:39,207 --> 02:21:41,109 THEY'RE FAIRNESS AND FIDELITY 3163 02:21:41,109 --> 02:21:43,178 AND SAFETY AND SYSTEM TRUST. 3164 02:21:43,178 --> 02:21:50,986 THE SYSTEM TRUST HAS TO DO WITH 3165 02:21:50,986 --> 02:21:51,419 MRE 3166 02:21:51,419 --> 02:21:52,053 BELIEFS IN INSTITUTION AND THE 3167 02:21:52,053 --> 02:21:54,156 ENTERPRISE AND THE RIGHT UPPER 3168 02:21:54,156 --> 02:21:56,057 BOX TALKS ABOUT CHARACTERISTICS 3169 02:21:56,057 --> 02:21:59,361 OF TRUST WORTHY RESEARCHERS. 3170 02:21:59,361 --> 02:22:00,662 REALLY TRYING TO AS BEST WE CAN 3171 02:22:00,662 --> 02:22:04,432 BE ACCESSIBLE, APPROACHABLE, 3172 02:22:04,432 --> 02:22:07,169 TAEPTIVE TO THE NEEDS AND 3173 02:22:07,169 --> 02:22:09,037 CONCERNS OF COMMUNITIES, 3174 02:22:09,037 --> 02:22:12,274 EMPATHETIC, HONEST, HUMBLE. 3175 02:22:12,274 --> 02:22:12,574 RESPECTFUL. 3176 02:22:12,574 --> 02:22:16,711 IN THE BOTTOM RIGHT BOX IS 3177 02:22:16,711 --> 02:22:19,581 SUPPORTIVE OF PRINCIPLES OF 3178 02:22:19,581 --> 02:22:23,151 COMMUNITY ENGAGED RESEARCH AND 3179 02:22:23,151 --> 02:22:28,990 CBPR AND THINKING ABOUT POWER 3180 02:22:28,990 --> 02:22:30,892 DYNAMICS AND TRANSPARENCY. 3181 02:22:30,892 --> 02:22:31,593 HOW DO YOU CREATE INFRASTRUCTURE 3182 02:22:31,593 --> 02:22:36,731 AND POLICIES TO BOLSTER UP 3183 02:22:36,731 --> 02:22:38,400 INFRASTRUCTURE FOR PLACES LIKE 3184 02:22:38,400 --> 02:22:41,203 NOT THE NIH MEDICAL RESEARCH 3185 02:22:41,203 --> 02:22:43,805 CENTER FOR BIG RESEARCH CENTERS 3186 02:22:43,805 --> 02:22:46,508 HOW ARE RESOURCES EQUITABLY 3187 02:22:46,508 --> 02:22:46,808 DISTRIBUTED. 3188 02:22:46,808 --> 02:22:48,743 DO WE HAVE THE IDEA OF EFFECTIVE 3189 02:22:48,743 --> 02:22:50,145 COMMUNICATION AND ESTABLISHING 3190 02:22:50,145 --> 02:22:56,351 PATTERNS OF FULFILLING TRUST AND 3191 02:22:56,351 --> 02:22:59,588 ALSO THE NOTION OF SHARED 3192 02:22:59,588 --> 02:23:05,660 DECISION MAKING AND VALUING 3193 02:23:05,660 --> 02:23:07,562 DIFFERENT RESOURCES AND 3194 02:23:07,562 --> 02:23:09,064 SOMETIMES AS RESEARCH GROUPS WE 3195 02:23:09,064 --> 02:23:12,434 COME INTO COMMUNITIES OR INTO 3196 02:23:12,434 --> 02:23:14,035 PARTNERSHIPS FROM A PLACE OF THE 3197 02:23:14,035 --> 02:23:17,272 INFORMATION AND RESOURCES THAT 3198 02:23:17,272 --> 02:23:23,411 WE CAN IMPART THE COMMUNITY AND 3199 02:23:23,411 --> 02:23:27,549 COMMUNITY ALSO HAS RESEARCH 3200 02:23:27,549 --> 02:23:28,116 RESOURCES VALUABLE TO THE 3201 02:23:28,116 --> 02:23:31,586 RESEARCH ENTERPRISE WE SHOULD 3202 02:23:31,586 --> 02:23:38,493 HONOR. 3203 02:23:38,493 --> 02:23:41,496 I HAVE THE BENEFIT OF WORKING 3204 02:23:41,496 --> 02:23:43,965 WITH A LOT OF DIFFERENT 3205 02:23:43,965 --> 02:23:46,935 RESEARCHERS AND STACY LOBE IS A 3206 02:23:46,935 --> 02:23:49,704 UROLOGIST AT NYU HEALTH SYSTEM 3207 02:23:49,704 --> 02:23:51,640 AND WITH THE MANHATTAN V.A. AND 3208 02:23:51,640 --> 02:23:55,744 LED A PROJECT I WAS A PART OF 3209 02:23:55,744 --> 02:24:01,783 LOOKING AT PERCEIVED TRUST IN 3210 02:24:01,783 --> 02:24:02,417 ONLINE VIDEOS ABOUT PROSTATE 3211 02:24:02,417 --> 02:24:02,884 CANCER. 3212 02:24:02,884 --> 02:24:04,753 THIS WAS A RANDOMIZED CLINICAL 3213 02:24:04,753 --> 02:24:06,855 TRIAL. 3214 02:24:06,855 --> 02:24:11,192 WE DID THIS TRIAL THROUGH A 3215 02:24:11,192 --> 02:24:14,462 SURVEY SAMPLING INTERNATIONAL AN 3216 02:24:14,462 --> 02:24:15,931 ONLINE SURVEY PANEL AND HOW THIS 3217 02:24:15,931 --> 02:24:18,099 CLINICAL TRIAL WAS SET UP WERE 3218 02:24:18,099 --> 02:24:23,171 PARTICIPANTS WERE RANL DOMIZED 3219 02:24:23,171 --> 02:24:29,010 TO ONE. 3220 02:24:29,010 --> 02:24:32,180 FOUR GROUPS AND SAW CLINICAL 3221 02:24:32,180 --> 02:24:38,453 TRIALS WITH A BLACK PHYSICIAN OR 3222 02:24:38,453 --> 02:24:39,521 WHITE PATIENT OR OTHER AND TOOK 3223 02:24:39,521 --> 02:24:40,689 A QUESTIONNAIRE AND THIS IS 3224 02:24:40,689 --> 02:24:41,790 TRUST IN THE INFORMATION IN THE 3225 02:24:41,790 --> 02:24:42,023 VIDEOS. 3226 02:24:42,023 --> 02:24:47,662 WE USED A VALIDATED GROUP 3227 02:24:47,662 --> 02:24:52,867 MINORITY-BASED MISTRUST SCALE BY 3228 02:24:52,867 --> 02:25:00,008 HAILEY THOMPSON AND TO THE HIGH 3229 02:25:00,008 --> 02:25:06,081 POINT KEY FINDING BLACK ADULTS 3230 02:25:06,081 --> 02:25:08,583 WERE MORE LIKELY TO TRUST A 3231 02:25:08,583 --> 02:25:11,586 VIDEO WITH A BLACK PRESENTERS 3232 02:25:11,586 --> 02:25:13,588 BUT IN WHITE ADULT THE COLOR OF 3233 02:25:13,588 --> 02:25:15,223 THE PRESENTER WAS NOT AFFILIATED 3234 02:25:15,223 --> 02:25:16,858 WITH TRUST. 3235 02:25:16,858 --> 02:25:18,526 THE TAKE HOME IS THAT 3236 02:25:18,526 --> 02:25:19,694 REPRESENTATION MATTERS, 3237 02:25:19,694 --> 02:25:22,397 DIVERSITY MATTERS AND NOT JUST 3238 02:25:22,397 --> 02:25:25,667 ON RESEARCH TEAMS BUT IN HEALTH 3239 02:25:25,667 --> 02:25:26,201 COMMUNICATION AND PATIENT 3240 02:25:26,201 --> 02:25:29,070 EDUCATION MATERIALS. 3241 02:25:29,070 --> 02:25:31,973 SO, MY LAST FEW SLIDES ARE 3242 02:25:31,973 --> 02:25:33,074 REALLY ABOUT POINTS TO CONSIDER 3243 02:25:33,074 --> 02:25:38,546 WHEN YOU'RE THINKING OF DRAFTING 3244 02:25:38,546 --> 02:25:39,581 RECRUITMENT AND RETENTION PLAN 3245 02:25:39,581 --> 02:25:42,183 FOR CLINICAL RESEARCH. 3246 02:25:42,183 --> 02:25:46,588 THIS INFORMATION IS FROM A NICE 3247 02:25:46,588 --> 02:25:47,989 ARTICLE POSTED ON THE NATIONAL 3248 02:25:47,989 --> 02:25:49,090 INSTITUTE OF MENTAL HEALTH 3249 02:25:49,090 --> 02:25:50,859 WEBSITE AND THE LINK IS THERE. 3250 02:25:50,859 --> 02:25:53,862 THE FIRST KEY CONCEPT IS 3251 02:25:53,862 --> 02:25:56,364 COMMUNITY ENGAGEMENT AND 3252 02:25:56,364 --> 02:25:58,199 QUESTIONS TO ASK YOURSELF AND 3253 02:25:58,199 --> 02:25:59,167 HOW DO YOU IDENTIFY COMMUNITIES 3254 02:25:59,167 --> 02:26:02,570 THAT YOU WOULD LIKE TO ENGAGE? 3255 02:26:02,570 --> 02:26:04,272 SO, EXAMPLES COULD BE 3256 02:26:04,272 --> 02:26:05,940 PARTICIPANTS AND THEIR FAMILY 3257 02:26:05,940 --> 02:26:06,174 MEMBERS. 3258 02:26:06,174 --> 02:26:08,143 IF THEY'RE LOOKING AT SOMETHING 3259 02:26:08,143 --> 02:26:10,545 LIKE ALZHEIMER'S OR PARKINSON'S 3260 02:26:10,545 --> 02:26:11,413 SUPPORT OR COMMUNITY CENTERS. 3261 02:26:11,413 --> 02:26:13,848 YOU ALSO WANT TO THINK THROUGH 3262 02:26:13,848 --> 02:26:14,616 BARRIERS TO PARTICIPATION. 3263 02:26:14,616 --> 02:26:17,318 SO WHAT ARE THE BARRIERS AND HOW 3264 02:26:17,318 --> 02:26:18,853 DO YOU ADDRESS THEM AND IT COULD 3265 02:26:18,853 --> 02:26:21,022 BE THINGS LIKE TIME OFF WORK OR 3266 02:26:21,022 --> 02:26:24,626 TRANSPORTATION OR IF IT'S A DRUG 3267 02:26:24,626 --> 02:26:26,594 STUDY OR SOME KIND OF CHANGE IN 3268 02:26:26,594 --> 02:26:27,429 HOW PEOPLE WILL MANAGE THEIR 3269 02:26:27,429 --> 02:26:28,763 HEALTH CONDITIONS THEY MAY NOT 3270 02:26:28,763 --> 02:26:29,397 WANT TO CHANGE THEIR MEDICATION 3271 02:26:29,397 --> 02:26:31,599 PLAN. 3272 02:26:31,599 --> 02:26:32,333 THERE'S ALSO BENEFITS TO 3273 02:26:32,333 --> 02:26:35,103 PARTICIPATION AND THIS IS REALLY 3274 02:26:35,103 --> 02:26:38,139 NOT WHAT WE THINK AS RESEARCHERS 3275 02:26:38,139 --> 02:26:41,643 ARE THE BENEFITS BUT THE 3276 02:26:41,643 --> 02:26:43,044 PERCEIVED BENEFITS FROM 3277 02:26:43,044 --> 02:26:43,578 POTENTIAL PARTICIPANTS. 3278 02:26:43,578 --> 02:26:46,948 AN THING YOU WOULD DO IS WORK 3279 02:26:46,948 --> 02:26:47,916 WITH COMMUNITIES THROUGH FOCUS 3280 02:26:47,916 --> 02:26:50,185 GROUPS OR INTERVIEWS OR SURVEYS 3281 02:26:50,185 --> 02:26:51,553 TO GET THEIR SIX REPORTED LIST 3282 02:26:51,553 --> 02:26:53,455 OF WHAT THEY THINK ARE THE 3283 02:26:53,455 --> 02:26:55,557 POTENTIAL BENEFITS OF WHAT 3284 02:26:55,557 --> 02:26:57,058 WHENEVER PROJECT YOU ARE 3285 02:26:57,058 --> 02:27:01,596 PROPOSING. 3286 02:27:01,596 --> 02:27:03,031 THERE ARE ALSO INFORMATIONAL 3287 02:27:03,031 --> 02:27:03,531 MATERIALS. 3288 02:27:03,531 --> 02:27:05,233 WILL THEY ACCOUNT FOR DIFFERENT 3289 02:27:05,233 --> 02:27:08,069 LEVELS OF LITERACY AND COGNITIVE 3290 02:27:08,069 --> 02:27:09,037 ABILITIES AND SUGGESTIONS HERE 3291 02:27:09,037 --> 02:27:11,573 TO THE BEST YOU CAN USE CLEAR 3292 02:27:11,573 --> 02:27:18,113 AND SIMPLE LANGUAGE. 3293 02:27:18,113 --> 02:27:18,880 THERE'S PLANNING AND TIME LINE 3294 02:27:18,880 --> 02:27:21,616 AND YOU KNOW THE TIME LINE 3295 02:27:21,616 --> 02:27:23,384 SOMEHOW SEEMS TO BE LONGER THAN 3296 02:27:23,384 --> 02:27:26,054 WHAT WE INITIALLY THINK. 3297 02:27:26,054 --> 02:27:27,822 ASKING YOURSELF AND EXPERIENCED 3298 02:27:27,822 --> 02:27:29,958 RESEARCHER IS THIS A REALISTIC 3299 02:27:29,958 --> 02:27:31,226 RECRUITMENT TIME LINE AND TO 3300 02:27:31,226 --> 02:27:33,061 THINK ABOUT IF THERE'S OTHER 3301 02:27:33,061 --> 02:27:43,571 LOCAL STUDIES IN YOUR AREA 3302 02:27:43,571 --> 02:27:45,473 ESTIMATES AND RECRUITMENT 3303 02:27:45,473 --> 02:27:47,542 STRATEGIES AND WHAT MECHANISMS 3304 02:27:47,542 --> 02:27:49,110 YOU'LL USE TO ENCOURAGE 3305 02:27:49,110 --> 02:27:50,578 RECRUITMENT AND MAKE SURE ALL 3306 02:27:50,578 --> 02:27:52,747 STAFF THAT COMMUNICATE WITH 3307 02:27:52,747 --> 02:27:53,481 POTENTIAL PARTICIPANTS RECEIVE 3308 02:27:53,481 --> 02:28:03,992 PROPER TRAINING AND PRACTICE. 3309 02:28:29,551 --> 02:28:33,021 GET CELL PHONE, PHONE NUMBER OR 3310 02:28:33,021 --> 02:28:38,126 FA MANY -- FAMILY MEMBERS AND 3311 02:28:38,126 --> 02:28:40,061 FRIENDS AND IT'S GOOD TO HAVE 3312 02:28:40,061 --> 02:28:42,330 MULTIPLE PHONE NUMBERS TO 3313 02:28:42,330 --> 02:28:45,066 FOLLOW-UP AND SEND SMALL TOKENS 3314 02:28:45,066 --> 02:28:46,467 OF APPRECIATION TO REMIND THEM 3315 02:28:46,467 --> 02:28:49,070 OF YOUR STUDY ESPECIALLY IF IT'S 3316 02:28:49,070 --> 02:28:51,072 NOT A ONE-TIME THING. 3317 02:28:51,072 --> 02:28:52,707 FINALLY, WHEN THE STUDY IS OVER 3318 02:28:52,707 --> 02:28:59,080 HOW ARE YOU GOING TO THANK 3319 02:28:59,080 --> 02:28:59,681 PARTICIPANTS AND ACKNOWLEDGE 3320 02:28:59,681 --> 02:29:10,225 THEM AND HOW WILL YOU MAINTAIN 3321 02:29:11,259 --> 02:29:12,393 RELATIONSHIPS. 3322 02:29:12,393 --> 02:29:16,064 I HOPE I GET FUNDED BY THE DASH 3323 02:29:16,064 --> 02:29:18,066 STUDY AND PUTTING OUT VIBES YOU 3324 02:29:18,066 --> 02:29:19,100 GET FULLY FUNDED BUT AFTER THAT 3325 02:29:19,100 --> 02:29:20,802 YOU DON'T WANT TO BE A 3326 02:29:20,802 --> 02:29:21,936 HELICOPTER RESEARCHER AND SHOW 3327 02:29:21,936 --> 02:29:23,972 UP WHEN YOU NEED ISSUING AND 3328 02:29:23,972 --> 02:29:25,540 DISAPPEAR AND COME BACK 10 YEARS 3329 02:29:25,540 --> 02:29:25,907 LATER. 3330 02:29:25,907 --> 02:29:27,075 HOW WILL YOU PLANK THAT 3331 02:29:27,075 --> 02:29:32,680 RELATIONSHIP? 3332 02:29:32,680 --> 02:29:35,049 SEND THANK YOU NOTES TO THOSE 3333 02:29:35,049 --> 02:29:37,252 INVOLVED IN YOUR STUDY AND 3334 02:29:37,252 --> 02:29:39,053 REPORT TO THE COMMUNITIES 3335 02:29:39,053 --> 02:29:39,487 INVOLVED. 3336 02:29:39,487 --> 02:29:42,857 PARTICIPANTS, FAMILY MEMBERS OF 3337 02:29:42,857 --> 02:29:43,458 PARTICIPANTS AND ALSO MAYBE 3338 02:29:43,458 --> 02:29:45,760 REFERRING PRACTITIONERS OR 3339 02:29:45,760 --> 02:29:46,561 CLINICIANS. 3340 02:29:46,561 --> 02:29:48,463 I FOUND HAVING WORKED IN SEVERAL 3341 02:29:48,463 --> 02:29:50,632 HEALTH SYSTEMS BUSY CLINICIANS 3342 02:29:50,632 --> 02:29:55,470 DO NOT WANT LONG RECORDS. 3343 02:29:55,470 --> 02:30:01,876 A LOT OF TIMES THEY LIKE SHORT 3344 02:30:01,876 --> 02:30:04,712 MEMOS TO TRYING TO BE CONCISE. 3345 02:30:04,712 --> 02:30:08,049 AND I'LL TALK ABOUT MY 3346 02:30:08,049 --> 02:30:10,485 PARTICIPATION IN THE PHASE 1 3347 02:30:10,485 --> 02:30:12,020 CLINICAL TRIAL FOR THE PFIZER 3348 02:30:12,020 --> 02:30:13,521 COVID VACCINE. 3349 02:30:13,521 --> 02:30:15,323 I WAS A PARTICIPANT AND THERE 3350 02:30:15,323 --> 02:30:16,958 WERE 14 VISITS OVER TWO YEARS 3351 02:30:16,958 --> 02:30:18,459 BUT ON MY LAST STUDY VISIT 3352 02:30:18,459 --> 02:30:19,961 THOUGH WE GOT PAID FOR ALL OF 3353 02:30:19,961 --> 02:30:24,799 OUR TIME AND VISITS, THEY GAVE 3354 02:30:24,799 --> 02:30:28,002 US THIS GIFT BOX AND THAT'S A 3355 02:30:28,002 --> 02:30:29,404 PIN. 3356 02:30:29,404 --> 02:30:31,806 IT'S A LITTLE BLURRY BUT A 3357 02:30:31,806 --> 02:30:34,042 LITTLE GIFT BOX AND I THOUGHT IT 3358 02:30:34,042 --> 02:30:37,278 WAS COOL AND SENT IT TO OUR 3359 02:30:37,278 --> 02:30:41,949 MARKETING AND COMMUNICATIONS 3360 02:30:41,949 --> 02:30:43,918 PERSON IN NEW YORK. 3361 02:30:43,918 --> 02:30:46,120 THE NET SAID YOUR COURAGE WROTE 3362 02:30:46,120 --> 02:30:46,988 HISTORY IT'S CLEAR OUR SURVIVAL 3363 02:30:46,988 --> 02:30:48,890 DEPENDS ON ONE ANOTHER. 3364 02:30:48,890 --> 02:30:52,827 WHEN YOU BECAME A CLINICAL TRIAL 3365 02:30:52,827 --> 02:30:54,495 VOLUNTEER FOR THE FIRST COVID-19 3366 02:30:54,495 --> 02:30:55,430 VACCINE TO BE APPROVED YOU 3367 02:30:55,430 --> 02:30:57,065 JOINED TENS OF THOUSANDS TO 3368 02:30:57,065 --> 02:31:02,136 BRING LIGHT TO A DARKENED WORLD. 3369 02:31:02,136 --> 02:31:04,205 WE OFFER THIS KEEPSAKE AND IN 3370 02:31:04,205 --> 02:31:06,307 THE BACK IT SAID PURSUIT OF HOPE 3371 02:31:06,307 --> 02:31:09,877 AND YOU CAN WRITE YOUR NAME IN 3372 02:31:09,877 --> 02:31:10,078 THERE. 3373 02:31:10,078 --> 02:31:12,847 I WAS FEELING EXTRA CITIZEN AND 3374 02:31:12,847 --> 02:31:17,085 HAPPY BUT IT WAS A NICE NOTE WE 3375 02:31:17,085 --> 02:31:20,088 LIGHT TO A DARKENED WORLD. 3376 02:31:20,088 --> 02:31:30,565 ANYWAY, THAT'S ONE EXAMPLE. 3377 02:31:32,066 --> 02:31:35,570 I DON'T HAVE STOCKS OR BONDS IN 3378 02:31:35,570 --> 02:31:36,571 PFI 3379 02:31:36,571 --> 02:31:36,871 PFIZER. 3380 02:31:36,871 --> 02:31:39,073 IT WAS OUR FIRST CONSENT FORM 3381 02:31:39,073 --> 02:31:41,943 AND IT WAS 20 PAGES AND 10-POINT 3382 02:31:41,943 --> 02:31:42,710 FONT. 3383 02:31:42,710 --> 02:31:45,646 I DID READ IT ALL BUT IT WAS A 3384 02:31:45,646 --> 02:31:47,548 LOT AND BECAUSE THERE WERE MINOR 3385 02:31:47,548 --> 02:31:49,217 CHANGES THROUGHOUT THE STUDY I 3386 02:31:49,217 --> 02:31:50,852 WAS THINKING THERE WERE TWO OR 3387 02:31:50,852 --> 02:31:54,021 THREE UPDATES TO THE CONCEPT 3388 02:31:54,021 --> 02:31:55,590 FORM AND I LEARNED A LOT AND I'M 3389 02:31:55,590 --> 02:31:56,924 HAPPY TO TALK MORE ABOUT IT. 3390 02:31:56,924 --> 02:31:59,594 I WANTED TO BE IN THE CLINICAL 3391 02:31:59,594 --> 02:32:01,028 TRIAL FOR A LOT OF REASONS. 3392 02:32:01,028 --> 02:32:04,432 ONE, I BELIEVE IN VACCINES AND I 3393 02:32:04,432 --> 02:32:05,767 WAS KIND OF SELFISH LIKE IF 3394 02:32:05,767 --> 02:32:06,934 THERE'S GOING TO BE A GOOD 3395 02:32:06,934 --> 02:32:08,336 VACCINE OR EFFECTIVE VACCINE I 3396 02:32:08,336 --> 02:32:09,404 WANT TO BE ONE OF OF THE FIRST 3397 02:32:09,404 --> 02:32:10,271 TO GET IT. 3398 02:32:10,271 --> 02:32:11,572 EVEN THE IDEA OF ME KNOWING 3399 02:32:11,572 --> 02:32:15,576 WHERE TO GO TO SIGN UP HAD SOME 3400 02:32:15,576 --> 02:32:17,712 LEVEL OF PRIVILEGE BECAUSE IT 3401 02:32:17,712 --> 02:32:19,514 WASN'T OBVIOUS AT THE BEGINNING 3402 02:32:19,514 --> 02:32:20,882 BUT HAD FRIENDS WHO GOT REALLY 3403 02:32:20,882 --> 02:32:22,817 SICK FROM COVID AND HAD THE 3404 02:32:22,817 --> 02:32:23,017 TIME. 3405 02:32:23,017 --> 02:32:26,354 I WANTED TO CONTRIBUTE. 3406 02:32:26,354 --> 02:32:28,055 I ALSO LEARNED A LOT AS A 3407 02:32:28,055 --> 02:32:30,224 RESEARCHER WHO HAD DONE CLINICAL 3408 02:32:30,224 --> 02:32:31,592 RESEARCH, BEING A PARTICIPANT 3409 02:32:31,592 --> 02:32:33,928 AND GOING THROUGH ALL THE STEPS 3410 02:32:33,928 --> 02:32:37,298 IT WAS VERY EYE-OPENING. 3411 02:32:37,298 --> 02:32:39,567 I PERSONALLY HAD A GOOD 3412 02:32:39,567 --> 02:32:43,438 EXPERIENCE BUT IT'S A LOT TO DO 3413 02:32:43,438 --> 02:32:45,072 ALL OF THAT. 3414 02:32:45,072 --> 02:32:48,142 I'M HAPPY TO TALK ABOUT IT BUT 3415 02:32:48,142 --> 02:32:50,578 AS PART OF MY OWN PARTICIPATION 3416 02:32:50,578 --> 02:32:52,313 IN THE PFIZER PHASE I STUDY AND 3417 02:32:52,313 --> 02:32:53,981 AT THE TIME DOING CLINICAL 3418 02:32:53,981 --> 02:32:55,383 TRIALS AND EDUCATION ABOUT THE 3419 02:32:55,383 --> 02:32:58,686 NEED FOR CLINICAL TRIAL 3420 02:32:58,686 --> 02:33:00,254 PARTICIPATION FOR THE VACCINE 3421 02:33:00,254 --> 02:33:02,790 TRIALS AND ALSO AFTER IT WAS 3422 02:33:02,790 --> 02:33:06,027 APPROVED TALKING A LOT TO 3423 02:33:06,027 --> 02:33:07,562 COMMUNITIES ABOUT CONSIDERING 3424 02:33:07,562 --> 02:33:08,763 GETTING VACCINATED. 3425 02:33:08,763 --> 02:33:12,366 IT INFORMED A LINE OF RESEARCH 3426 02:33:12,366 --> 02:33:14,869 SO I HAVE ANOTHER GRANT 3427 02:33:14,869 --> 02:33:18,206 APPLICATION UNDER REVIEW ABOUT 3428 02:33:18,206 --> 02:33:21,075 ENHANCING OR REDUCING VACCINE 3429 02:33:21,075 --> 02:33:25,246 HESITANCY FOR FLU AND COVID 3430 02:33:25,246 --> 02:33:25,513 VACCINES. 3431 02:33:25,513 --> 02:33:29,684 AND HERE THIS IS REALLY JUST A 3432 02:33:29,684 --> 02:33:32,053 SIMPLIFIED GRAPH IN TERMS OF 3433 02:33:32,053 --> 02:33:35,923 VACCINE ACCEPTANCE THERE'S SOME 3434 02:33:35,923 --> 02:33:38,025 PEOPLE WHO REFUSE ALL VACCINES 3435 02:33:38,025 --> 02:33:40,495 AND SOME WHO WILL JUST DELAY 3436 02:33:40,495 --> 02:33:40,761 VACCINES. 3437 02:33:40,761 --> 02:33:42,530 YOU MAY ACCEPT VACCINATIONS BUT 3438 02:33:42,530 --> 02:33:43,264 HAVE CONCERNS. 3439 02:33:43,264 --> 02:33:46,534 IF YOU WORK FOR A HEALTH SYSTEM 3440 02:33:46,534 --> 02:33:47,468 THAT REQUIRES THE FLU SHOT YOU 3441 02:33:47,468 --> 02:33:50,204 MAY BE CONCERNED ABOUT THE FLU 3442 02:33:50,204 --> 02:33:51,772 SHOT BUT MAY NEED TO KEEP YOUR 3443 02:33:51,772 --> 02:33:53,207 JOB AND PAY YOUR BILLS AND HAVE 3444 02:33:53,207 --> 02:33:55,643 PEOPLE LIKE ME WHERE THERE'S A 3445 02:33:55,643 --> 02:33:57,245 MILLION THINGS TO BE WORRIED 3446 02:33:57,245 --> 02:33:58,145 ABOUT. 3447 02:33:58,145 --> 02:33:59,146 I PERSONALLY WOULDN'T BE 3448 02:33:59,146 --> 02:34:00,348 CONCERNED ABOUT VACCINE AND GET 3449 02:34:00,348 --> 02:34:02,049 ALL THE AGE APPROPRIATE VACCINES 3450 02:34:02,049 --> 02:34:04,785 I CAN GET BUT MAYBE I'M A WEIRD 3451 02:34:04,785 --> 02:34:07,288 BIRD OR WHATEVER. 3452 02:34:07,288 --> 02:34:11,259 MY LAST EXAMPLE HERE, THIS IS A 3453 02:34:11,259 --> 02:34:16,464 REAL STUDY OF LOOKING AT LOW 3454 02:34:16,464 --> 02:34:19,567 PATHOGENICITY FOR THIS INFLUENZA 3455 02:34:19,567 --> 02:34:21,636 VIRUS IN A HEALTHY HUMAN 3456 02:34:21,636 --> 02:34:23,070 CHALLENGE MODEL. 3457 02:34:23,070 --> 02:34:28,743 FOR THOSE NOT FAMILIAR WITH 3458 02:34:28,743 --> 02:34:29,944 HUMAN CHALLENGE TRIALS THEY'RE 3459 02:34:29,944 --> 02:34:31,412 PURPOSELY INFECTING PEOPLE WITH 3460 02:34:31,412 --> 02:34:37,385 THE VIRUS WHO ARE HEALTHY AND 3461 02:34:37,385 --> 02:34:38,219 LOOKING AT THE IMMUNE RESPONSE 3462 02:34:38,219 --> 02:34:39,320 IN THOSE PEOPLE. 3463 02:34:39,320 --> 02:34:41,422 THESE FOLKS HAVE TO BE WILLING 3464 02:34:41,422 --> 02:34:44,959 TO BE INFECTED WITH THE 3465 02:34:44,959 --> 02:34:47,061 VIRUS-LIKE FLU. 3466 02:34:47,061 --> 02:34:48,029 THIS RECRUITMENT IS WRAPPING UP 3467 02:34:48,029 --> 02:34:50,831 SOON BUT IT'S A TRIAL BEING 3468 02:34:50,831 --> 02:34:53,634 FUNDED AND DONE RIGHT HERE AT 3469 02:34:53,634 --> 02:34:54,068 NIH. 3470 02:34:54,068 --> 02:34:56,037 IF YOU ARE INTERESTED YOU CAN 3471 02:34:56,037 --> 02:34:57,138 LOOK AT THE QR CODE. 3472 02:34:57,138 --> 02:34:59,473 I'LL TELL YOU WHAT SOME OF THE 3473 02:34:59,473 --> 02:35:03,444 REQUIREMENTS ARE. 3474 02:35:03,444 --> 02:35:05,613 SO YOU HAVE TO BE A HEALTHY 3475 02:35:05,613 --> 02:35:10,751 PERSON BETWEEN 18 AND 50. 3476 02:35:10,751 --> 02:35:12,720 YOU ACTUALLY ALSO YOU'LL GET 3477 02:35:12,720 --> 02:35:14,355 COMPENSATED BUT IF YOU CHOOSE TO 3478 02:35:14,355 --> 02:35:16,691 TO THE HUMAN CHALLENGE TRIAL YOU 3479 02:35:16,691 --> 02:35:21,062 ACTUALLY HAVE TO DO A PRESCREEN 3480 02:35:21,062 --> 02:35:22,697 AND THEN HAVE TO COME TO THE 3481 02:35:22,697 --> 02:35:24,465 CLINICAL CENTER IN BETHESDA AND 3482 02:35:24,465 --> 02:35:28,269 HAVE TO STAY NINE DAYS IN 3483 02:35:28,269 --> 02:35:29,637 PATIENT HOSPITAL AND THERE'S 3484 02:35:29,637 --> 02:35:30,204 FOUR OUT PATIENT FOLLOW-UP 3485 02:35:30,204 --> 02:35:35,076 VISITS. 3486 02:35:35,076 --> 02:35:36,944 18 TO 50 AND NINE IN THE 3487 02:35:36,944 --> 02:35:37,945 HOSPITAL AND FOLLOW-UP. 3488 02:35:37,945 --> 02:35:38,479 THAT'S EVERYBODY. 3489 02:35:38,479 --> 02:35:39,747 YOU GUYS ARE IN RESEARCH. 3490 02:35:39,747 --> 02:35:41,682 I'M SURE YOU WOULD SIGN UP RIGHT 3491 02:35:41,682 --> 02:35:46,854 NOW BECAUSE YOU SUPPORT THE 3492 02:35:46,854 --> 02:35:49,457 MISSION OF NIH. 3493 02:35:49,457 --> 02:35:54,128 THE NEXT SLIDE IF YOU GO TO 3494 02:35:54,128 --> 02:35:54,795 CLINICALTRIALS.gov THEY GIVE 3495 02:35:54,795 --> 02:35:55,830 BACKGROUND ON THE FLU AND WHY 3496 02:35:55,830 --> 02:35:56,464 IT'S IMPORTANT. 3497 02:35:56,464 --> 02:35:59,233 THEY WANT TO FIND THE SMALLEST 3498 02:35:59,233 --> 02:36:01,402 DOSE OF THIS INFLUENZA VIRUS 3499 02:36:01,402 --> 02:36:05,873 THAT PLAY CAUSE UNCOMPLICATED TO 3500 02:36:05,873 --> 02:36:08,643 MILD FLU INFECTION IN HEALTHY 3501 02:36:08,643 --> 02:36:11,178 PEOPLE AND USED TO INFORM HOW 3502 02:36:11,178 --> 02:36:13,948 THE NEXT FLU VACCINES WILL WORK. 3503 02:36:13,948 --> 02:36:19,520 SO I THINK THIS IS OUR LAST 3504 02:36:19,520 --> 02:36:21,055 GROUP QUESTION IF YOU GO BACK TO 3505 02:36:21,055 --> 02:36:22,623 SLIDO, IF YOU WERE IN CHARGE OF 3506 02:36:22,623 --> 02:36:25,292 THE RECRUITMENT AND RETENTION 3507 02:36:25,292 --> 02:36:27,028 PLAN FOR THIS HUMAN CHALLENGE 3508 02:36:27,028 --> 02:36:28,963 STUDY, WHERE WOULD YOU RECRUIT 3509 02:36:28,963 --> 02:36:29,196 PEOPLE? 3510 02:36:29,196 --> 02:36:34,035 AGAIN, THEY HAVE TO BE 18 TO 50. 3511 02:36:34,035 --> 02:36:36,103 THEY HAVE TO BE WILLING TO STATE 3512 02:36:36,103 --> 02:36:37,038 IN THE NIH CLINICAL CENTER 3513 02:36:37,038 --> 02:36:38,339 HOSPITAL FOR NINE DAYS AND COME 3514 02:36:38,339 --> 02:36:39,840 BACK FOR FOUR VISITS. 3515 02:36:39,840 --> 02:36:42,109 THEY'RE COMPENSATED BUT THE 3516 02:36:42,109 --> 02:36:43,077 COMPENSATION AMOUNT WAS NOT ON 3517 02:36:43,077 --> 02:36:45,946 THE WEBSITE SO I DON'T KNOW HOW 3518 02:36:45,946 --> 02:36:50,217 MUCH THEY'RE COMPENSATED. 3519 02:36:50,217 --> 02:36:53,120 CAN YOU SEE THE SLIDO OPTIONS. 3520 02:36:53,120 --> 02:36:55,256 >> FOR THOSE WHO NEED A REMINDER 3521 02:36:55,256 --> 02:37:03,564 THE NUMBER IS 2997361. 3522 02:37:03,564 --> 02:37:04,899 WE HAVE SOME VOTES COMING IN. 3523 02:37:04,899 --> 02:37:06,167 >> I DON'T KNOW IT YOU SEE THEM 3524 02:37:06,167 --> 02:37:07,134 BACK TO BACK. 3525 02:37:07,134 --> 02:37:07,935 THE FIRST QUESTION IS WHERE 3526 02:37:07,935 --> 02:37:10,237 WOULD YOU RECRUIT PEOPLE AND 3527 02:37:10,237 --> 02:37:12,707 WHAT CHALLENGES, IF ANY, DO YOU 3528 02:37:12,707 --> 02:37:13,374 ANTICIPATE WITH TRYING TO 3529 02:37:13,374 --> 02:37:18,846 RECRUIT PEOPLE FOR THE HUMAN 3530 02:37:18,846 --> 02:37:21,048 CHALLENGE MODEL. 3531 02:37:21,048 --> 02:37:27,488 >> I'M HAVING THE FIRST ONE 3532 02:37:27,488 --> 02:37:31,592 OPEN AND RIGHT KNOW SOCIAL MEDIA 3533 02:37:31,592 --> 02:37:32,393 IS WINNING. 3534 02:37:32,393 --> 02:37:34,195 RESEARCH MATCH IS A STRONG 3535 02:37:34,195 --> 02:37:34,428 SECOND. 3536 02:37:34,428 --> 02:37:37,665 >> OKAY. 3537 02:37:37,665 --> 02:37:43,270 >> VERY FEW PEOPLE SAY 3538 02:37:43,270 --> 02:37:43,704 CLINICALTRIALS.gov. 3539 02:37:43,704 --> 02:37:45,806 A COUPLE PEOPLE AREN'T SURE. 3540 02:37:45,806 --> 02:37:47,041 >> OKAY. 3541 02:37:47,041 --> 02:37:47,975 IT I DON'T KNOW IF I WAS IN 3542 02:37:47,975 --> 02:37:50,077 CHARGE OF RECRUITMENT AND 3543 02:37:50,077 --> 02:37:51,245 RETENTION HOW FAR I'D GO. 3544 02:37:51,245 --> 02:37:52,613 WE NEED HEALTHY PEOPLE IN THE 3545 02:37:52,613 --> 02:37:55,549 WORLD WILLING TO BE INFECTED 3546 02:37:55,549 --> 02:38:02,790 WITH THE VIRUS. 3547 02:38:02,790 --> 02:38:05,826 IT'S JUST THE FLU. 3548 02:38:05,826 --> 02:38:07,728 EARLY ON IN THE FIRST YEAR OF 3549 02:38:07,728 --> 02:38:09,730 COVID THE MEDICAL ETHICS GROUP 3550 02:38:09,730 --> 02:38:13,100 WHERE I WAS AT NYU HAD A 3551 02:38:13,100 --> 02:38:15,069 SYMPOSIUM ON SHOULD THEY ARE 3552 02:38:15,069 --> 02:38:17,037 HAVE HUMAN CHALLENGE TRIALS FOR 3553 02:38:17,037 --> 02:38:17,938 COVID. 3554 02:38:17,938 --> 02:38:20,574 AND MOST PEOPLE SAID NO BECAUSE 3555 02:38:20,574 --> 02:38:22,610 WE HAVE NO EXPERIENCE OR FOR 3556 02:38:22,610 --> 02:38:24,211 MITIGATION BUT THERE WERE 3557 02:38:24,211 --> 02:38:25,045 PHILOSOPHICAL QUESTIONS WOULD IT 3558 02:38:25,045 --> 02:38:30,651 BE ETHICAL DURING 2020 TO INFECT 3559 02:38:30,651 --> 02:38:32,019 PEOPLE WITH COVID-19 TO INFORM 3560 02:38:32,019 --> 02:38:33,053 TREATMENT DEVELOPMENT. 3561 02:38:33,053 --> 02:38:36,924 >> THE CLEAR WINNER WAS SOCIAL 3562 02:38:36,924 --> 02:38:40,828 MEDIA AND VERY FEW FOR 3563 02:38:40,828 --> 02:38:43,564 CLINICALTRIALS.gov AND NOW I 3564 02:38:43,564 --> 02:38:46,500 HAVE OPENED THE QUESTION WHAT 3565 02:38:46,500 --> 02:38:48,102 CHALLENGE, IF ANY, DO YOU 3566 02:38:48,102 --> 02:38:48,736 ANTICIPATE. 3567 02:38:48,736 --> 02:38:51,005 FEEL FREE TO SEND IN YOUR 3568 02:38:51,005 --> 02:38:51,272 COMMENTS. 3569 02:38:51,272 --> 02:38:52,406 WE HAVE -- WHO'S GOING TO TAKE 3570 02:38:52,406 --> 02:38:59,313 OFF THE TIME FOR WORK? 3571 02:38:59,313 --> 02:39:01,348 COMMUNICATIONS. 3572 02:39:01,348 --> 02:39:05,386 NINE DAYS IN THE HOSPITAL WILL 3573 02:39:05,386 --> 02:39:07,521 BE A CHALLENGE. 3574 02:39:07,521 --> 02:39:09,290 >> WHY YOU'RE ALL INDEPENDENTLY 3575 02:39:09,290 --> 02:39:09,757 WEALTHY. 3576 02:39:09,757 --> 02:39:11,392 >> WHAT IF YOU GET SICK? 3577 02:39:11,392 --> 02:39:13,060 THAT MAY BE A REASON NOT TO 3578 02:39:13,060 --> 02:39:13,294 ENROLL. 3579 02:39:13,294 --> 02:39:19,500 A COUPLE MORE TIME OFF WORK. 3580 02:39:19,500 --> 02:39:21,001 WHO'S GOING TO HAVE THE TIME TO 3581 02:39:21,001 --> 02:39:21,802 DO THAT. 3582 02:39:21,802 --> 02:39:23,571 WHAT IF YOU HAVE FAMILIES OR A 3583 02:39:23,571 --> 02:39:27,541 DOG TO TAKE CARE OF? 3584 02:39:27,541 --> 02:39:31,378 AND MAYBE MISUNDERSTANDING ABOUT 3585 02:39:31,378 --> 02:39:33,514 THE STUDY IT SOUNDS 3586 02:39:33,514 --> 02:39:35,583 CONSPIRAT 3587 02:39:35,583 --> 02:39:37,184 CONSPIRATORIAL. 3588 02:39:37,184 --> 02:39:37,818 BETHESDA, IN THE EVERYBODY LIVES 3589 02:39:37,818 --> 02:39:46,160 IN THE AREA. 3590 02:39:46,160 --> 02:39:47,962 CHILDCARE, TRANSPORT. 3591 02:39:47,962 --> 02:39:49,964 BACKLASH FROM THE ANTI-VACCINE 3592 02:39:49,964 --> 02:39:50,497 PEOPLE. 3593 02:39:50,497 --> 02:39:53,634 >> THE ANTI-VAXERS THEY'LL SAY 3594 02:39:53,634 --> 02:39:55,803 SEE THEY WERE TRYING TO INFECT 3595 02:39:55,803 --> 02:39:58,272 ALL OF US THE WHOLE TIME. 3596 02:39:58,272 --> 02:39:59,440 >> I NEED TO KNOW HOW MUCH 3597 02:39:59,440 --> 02:40:03,143 YOU'RE GOING TO PAY ME. 3598 02:40:03,143 --> 02:40:10,150 >> INTERESTING. 3599 02:40:10,150 --> 02:40:13,587 >> HOW ARE WE GOING TO ATTRACT 3600 02:40:13,587 --> 02:40:16,023 FOLKS FROM LOWER SES, I'M 3601 02:40:16,023 --> 02:40:17,758 PUTTING WORDS IN THEIR MOUTH. 3602 02:40:17,758 --> 02:40:19,159 CAN YOU TAKE NINE DAYS OFF? 3603 02:40:19,159 --> 02:40:27,067 CAN YOU TRANSPORT YOURSELF TO 3604 02:40:27,067 --> 02:40:27,534 BETHESDA? 3605 02:40:27,534 --> 02:40:30,170 >> GREAT QUESTIONS. 3606 02:40:30,170 --> 02:40:31,305 THAT'S MY LAST SLIDE AND HAPPY 3607 02:40:31,305 --> 02:40:32,773 TO TAKE QUESTIONS BUT I THOUGHT 3608 02:40:32,773 --> 02:40:34,008 THAT WAS AN INTERESTING TRIAL TO 3609 02:40:34,008 --> 02:40:35,142 THINK ABOUT BECAUSE YOU HAVE TO 3610 02:40:35,142 --> 02:40:37,845 COME TO A PLACE AND BE INFECTED. 3611 02:40:37,845 --> 02:40:40,781 IT'S JUST THE FLU. 3612 02:40:40,781 --> 02:40:42,249 HAPPY TO TAKE QUESTIONS AND 3613 02:40:42,249 --> 02:40:45,586 THANKS FOR PARTICIPATING. 3614 02:40:45,586 --> 02:40:49,790 >> AND TO POINT OUT THE 3615 02:40:49,790 --> 02:40:50,591 DIFFERENCE. 3616 02:40:50,591 --> 02:40:53,794 ONE OF THE POINTS YOU WERE 3617 02:40:53,794 --> 02:40:54,828 CLEARLY MAKING IS HOW YOU'LL 3618 02:40:54,828 --> 02:40:57,064 THINK ABOUT RECRUITMENT AND 3619 02:40:57,064 --> 02:41:01,669 RETENTION DEPENDS ON ALL SORTS 3620 02:41:01,669 --> 02:41:04,038 OF THINGS INCLUDING THE TRIAL 3621 02:41:04,038 --> 02:41:04,838 YOU'LL ASK THEM. 3622 02:41:04,838 --> 02:41:09,476 FOR THE TRIAL MAYBE THERE'S A 3623 02:41:09,476 --> 02:41:11,145 GROUP OF PEOPLE THAT MAYBE THIS 3624 02:41:11,145 --> 02:41:13,514 GROUP WOULD BE AN IDEAL GROUP TO 3625 02:41:13,514 --> 02:41:14,949 RECRUIT FOR A CHALLENGE STUDY. 3626 02:41:14,949 --> 02:41:15,883 >> GREAT. 3627 02:41:15,883 --> 02:41:17,685 YOU GUYS ARE ALL RAISING YOUR 3628 02:41:17,685 --> 02:41:17,985 HANDS. 3629 02:41:17,985 --> 02:41:19,820 YOU'RE BOSSES WILL GIVE YOU TIME 3630 02:41:19,820 --> 02:41:20,421 OFF. 3631 02:41:20,421 --> 02:41:23,524 YOU WORK AT NIH, RIGHT? 3632 02:41:23,524 --> 02:41:32,499 >> TO SAY IF I WAS DEVISING THE 3633 02:41:32,499 --> 02:41:34,468 RECRUITMENT STRATEGY I MIGHT 3634 02:41:34,468 --> 02:41:35,536 WANT PEOPLE WHO KNOW ABOUT 3635 02:41:35,536 --> 02:41:37,538 SCIENCE AND LIVE IN BETHESDA AND 3636 02:41:37,538 --> 02:41:40,307 HAVE A RELATIVELY HIGH EDUCATION 3637 02:41:40,307 --> 02:41:40,507 LEVEL. 3638 02:41:40,507 --> 02:41:42,977 SO VERSUS SOME OF YOUR 3639 02:41:42,977 --> 02:41:43,577 CARDIOVASCULAR TRIALS IN THE 3640 02:41:43,577 --> 02:41:45,879 COMMUNITY YOU MIGHT HAVE A VERY 3641 02:41:45,879 --> 02:41:46,880 DIFFERENT PRIORITY IN TERMS OF 3642 02:41:46,880 --> 02:41:50,317 HOW YOU'RE THINKING ABOUT 3643 02:41:50,317 --> 02:41:51,552 RECRUITMENT AND RETENTION. 3644 02:41:51,552 --> 02:41:52,419 >> ABSOLUTELY. 3645 02:41:52,419 --> 02:41:53,754 ANY QUESTIONS? 3646 02:41:53,754 --> 02:41:55,189 I CAN'T SEE ANY FROM THE GROUP. 3647 02:41:55,189 --> 02:41:57,091 PLEASE COME UP TO THE MIKE. 3648 02:41:57,091 --> 02:42:00,361 I'LL GO BACK OVER TO VIDEO LAND 3649 02:42:00,361 --> 02:42:01,829 AND SEE IF THERE ARE SOME. 3650 02:42:01,829 --> 02:42:02,529 JONATHAN, GO AHEAD. 3651 02:42:02,529 --> 02:42:03,497 >> THANKS FOR THE TALK. 3652 02:42:03,497 --> 02:42:06,934 I HAD A QUESTION ABOUT THE 3653 02:42:06,934 --> 02:42:09,570 CHARACTERISTICS OF TRUSTWORTHY 3654 02:42:09,570 --> 02:42:10,371 RESEARCHERS. 3655 02:42:10,371 --> 02:42:12,740 YOU MENTIONED WILKENS. 3656 02:42:12,740 --> 02:42:13,974 JUST CURIOUS, DO YOU KNOW HOW 3657 02:42:13,974 --> 02:42:15,542 THEY DETERMINED WHAT THE 3658 02:42:15,542 --> 02:42:17,378 CHARACTERISTICS ARE OR HOW 3659 02:42:17,378 --> 02:42:19,546 RESEARCHERS MIGHT DO THAT IN 3660 02:42:19,546 --> 02:42:19,947 GENERAL. 3661 02:42:19,947 --> 02:42:22,316 WAS IT A BUNCH OF DATA AND TRIED 3662 02:42:22,316 --> 02:42:25,719 TO NOTICE CERTAIN PATTERNS OR 3663 02:42:25,719 --> 02:42:27,054 DID THEY HAVE A PARTICULAR 3664 02:42:27,054 --> 02:42:27,554 METHOD? 3665 02:42:27,554 --> 02:42:30,391 I DO NOT KNOW OFFHAND BUT I 3666 02:42:30,391 --> 02:42:40,901 ACTUALLY HAVE IT PRINTED OUT. 3667 02:42:44,104 --> 02:42:47,541 I KNOW FROM OTHER CONCEPTUAL 3668 02:42:47,541 --> 02:42:49,276 MODELS THEY'VE DONE FOCUS GROUPS 3669 02:42:49,276 --> 02:42:50,744 WITH COMMUNITY MEMBERS AND 3670 02:42:50,744 --> 02:42:53,213 SURVEYS ON WHAT PEOPLE PERCEIVE 3671 02:42:53,213 --> 02:42:59,520 AS WHAT WOULD BE A TRUSTWORTHY 3672 02:42:59,520 --> 02:43:03,090 RESEARCHER OR INSTITUTION AND 3673 02:43:03,090 --> 02:43:11,398 THEN AND INFORMED BY PRINCIPLES 3674 02:43:11,398 --> 02:43:12,566 OF COMMUNITY RESEARCH WHICH DOES 3675 02:43:12,566 --> 02:43:15,069 COME FROM THE COMMUNITY BUT ALSO 3676 02:43:15,069 --> 02:43:16,236 A LOT OF COMMUNITY-MINDED 3677 02:43:16,236 --> 02:43:17,738 RESEARCHERS SAYING IN AN IDEAL 3678 02:43:17,738 --> 02:43:23,310 WORLD THIS IS HOW WE CAN DO 3679 02:43:23,310 --> 02:43:27,081 RESEARCH BETTER. 3680 02:43:27,081 --> 02:43:33,187 GREAT QUESTION. 3681 02:43:33,187 --> 02:43:35,556 >> I HAVE A QUESTION ABOUT 3682 02:43:35,556 --> 02:43:37,057 RESEARCH MATCH.org. 3683 02:43:37,057 --> 02:43:40,360 I'M WONDERING HOW THEY'VE BEEN 3684 02:43:40,360 --> 02:43:42,162 PUBLICIZING. 3685 02:43:42,162 --> 02:43:43,564 100,000 PEOPLE SIGNED UP SOUNDS 3686 02:43:43,564 --> 02:43:45,065 LIKE A LOT. 3687 02:43:45,065 --> 02:43:47,935 >> IT'S LIKE 120 NOW AND EACH 3688 02:43:47,935 --> 02:43:51,872 TIME I'VE GIVEN THE TALK IT WAS 3689 02:43:51,872 --> 02:43:53,540 LIKE AT 93,000. 3690 02:43:53,540 --> 02:43:54,074 I'M NOT SURE. 3691 02:43:54,074 --> 02:43:58,579 I KNOW THEY WERE TRYING TO GET 3692 02:43:58,579 --> 02:44:00,447 THE WORD OUT THROUGH SOME 3693 02:44:00,447 --> 02:44:02,816 ACADEMIC PARTNERS THAT ARE 3694 02:44:02,816 --> 02:44:03,083 INVOLVED. 3695 02:44:03,083 --> 02:44:05,152 I THINK THERE'S CLOSE TO OVER 3696 02:44:05,152 --> 02:44:09,957 1,000 OR CLOSE TO 1500 3697 02:44:09,957 --> 02:44:10,290 INSTITUTIONS. 3698 02:44:10,290 --> 02:44:12,392 I HAVEN'T REALLY SEEN IT ON 3699 02:44:12,392 --> 02:44:13,260 BILLBOARDS AND THINGS AND IF 3700 02:44:13,260 --> 02:44:18,232 YOU'RE NOT LOOKING FOR IT, YOU 3701 02:44:18,232 --> 02:44:20,601 MAY NOT HAVE SEEN IT BUT AND 3702 02:44:20,601 --> 02:44:22,069 IT'S BEEN AROUND I THINK AT 3703 02:44:22,069 --> 02:44:23,704 LEAST A DECADE NOW. 3704 02:44:23,704 --> 02:44:25,472 MAYBE THERE WERE MORE EFFORTS AT 3705 02:44:25,472 --> 02:44:28,775 THE BEGINNING OR MORE OBVIOUS 3706 02:44:28,775 --> 02:44:29,009 EFFORTS. 3707 02:44:29,009 --> 02:44:31,411 I KNOW LIKE FOR ALL OF US, I 3708 02:44:31,411 --> 02:44:33,947 DON'T SEE A TON FOR ALL OF US 3709 02:44:33,947 --> 02:44:34,948 EITHER BUT BELIEVE WHEN IT FIRST 3710 02:44:34,948 --> 02:44:36,984 CAME OUT THROUGH ACADEMIC 3711 02:44:36,984 --> 02:44:38,418 MEDICAL CENTERS IT WAS A BIG 3712 02:44:38,418 --> 02:44:41,255 THING AND I SEE BILLBOARDS BUT 3713 02:44:41,255 --> 02:44:42,956 I'M ALSO AT NIH SO I EXPECT TO 3714 02:44:42,956 --> 02:44:44,124 SEE THINGS FOR ALL OF US. 3715 02:44:44,124 --> 02:44:46,093 I DON'T KNOW WHAT THEIR PARKING 3716 02:44:46,093 --> 02:44:47,794 PLAN IS RIGHT NOW. 3717 02:44:47,794 --> 02:44:49,596 -- MARKETING PLAN IS. 3718 02:44:49,596 --> 02:44:54,001 >> IS IT FOR HEALTHY VOLUNTEERS 3719 02:44:54,001 --> 02:44:55,936 OR CONDITION SPECIFIC? 3720 02:44:55,936 --> 02:44:57,070 >> BOTH. 3721 02:44:57,070 --> 02:45:00,507 YOU CAN ACTUALLY QUERY I THINK 3722 02:45:00,507 --> 02:45:01,742 IT'S LIKE THE ABOUT US SECTION 3723 02:45:01,742 --> 02:45:03,076 BUT SEE PERCENTAGES. 3724 02:45:03,076 --> 02:45:05,846 I DID SIGN UP FOR IT BUT CAN'T 3725 02:45:05,846 --> 02:45:07,581 REMEMBER ALL THE CONDITIONS BUT 3726 02:45:07,581 --> 02:45:09,016 THERE'S INFORMATION ABOUT PEOPLE 3727 02:45:09,016 --> 02:45:13,253 WITH DIABETES, HYPERTENSION, 3728 02:45:13,253 --> 02:45:15,355 MAYBE 150 OR 20 CONDITIONS AND 3729 02:45:15,355 --> 02:45:20,460 PEOPLE WHO ARE HEALTHY 3730 02:45:20,460 --> 02:45:20,761 VOLUNTEERS. 3731 02:45:20,761 --> 02:45:22,296 AND ALSO SURROGATES WHO WOULD BE 3732 02:45:22,296 --> 02:45:24,131 INTERESTED IN STUDIES FOR 3733 02:45:24,131 --> 02:45:24,398 CHILDREN. 3734 02:45:24,398 --> 02:45:26,700 IT'S A MIX OF HEALTHY VOLUNTEERS 3735 02:45:26,700 --> 02:45:29,102 AND PEOPLE WHO HAVE 3736 02:45:29,102 --> 02:45:30,070 SELF-REPORTED CONDITIONS AND 3737 02:45:30,070 --> 02:45:31,471 IT'S A REGISTRY WHERE PEOPLE 3738 02:45:31,471 --> 02:45:33,740 LIKE PROACTIVELY SIGN UP FOR IT. 3739 02:45:33,740 --> 02:45:35,142 BUT YOU DON'T HAVE TO -- YOU 3740 02:45:35,142 --> 02:45:38,378 HAVE TO BE SIGNED UP TO GET THE 3741 02:45:38,378 --> 02:45:42,449 ALERTS EVERY SO OFTEN BUT ANYONE 3742 02:45:42,449 --> 02:45:44,618 IN THE WORLD AT CLINICAL TRIALS 3743 02:45:44,618 --> 02:45:47,120 CAN GO ON RESEARCH MATCH.org WHO 3744 02:45:47,120 --> 02:45:49,323 DOESN'T WANT TO SIGN UP 3745 02:45:49,323 --> 02:45:50,090 OFFICIALLY AND SEE CLINICAL 3746 02:45:50,090 --> 02:45:50,791 TRIALS AVAILABLE. 3747 02:45:50,791 --> 02:45:52,025 IT'S A MIX OF BOTH. 3748 02:45:52,025 --> 02:45:53,894 >> THAT'S A GOOD POINT. 3749 02:45:53,894 --> 02:45:57,130 THOSE HUNDREDS OF THOUSANDS OF 3750 02:45:57,130 --> 02:45:58,765 PEOPLE REGISTERED BUT IF ATTACK 3751 02:45:58,765 --> 02:46:01,335 I WANTED TO LOOK UP CANCER 3752 02:46:01,335 --> 02:46:05,239 TRIALS IN BETHESDA, I DON'T HAVE 3753 02:46:05,239 --> 02:46:09,042 TO REGISTER. 3754 02:46:09,042 --> 02:46:11,812 >> AND THE ENGINE BEHIND 3755 02:46:11,812 --> 02:46:13,780 RESEARCH MATCH IS ACTUALLY 3756 02:46:13,780 --> 02:46:15,549 CLINICAL TRIALS.gov. 3757 02:46:15,549 --> 02:46:18,252 IT LOOKS NICER IN MY OPINION AND 3758 02:46:18,252 --> 02:46:21,088 MORE USER FRIENDLY TO SEE IT 3759 02:46:21,088 --> 02:46:24,925 THROUGH THE INTERFACE BUT PEOPLE 3760 02:46:24,925 --> 02:46:25,892 SEARCHING WHO HAVEN'T REGISTERED 3761 02:46:25,892 --> 02:46:28,362 WHAT IS FEEDING THAT IS CLINICAL 3762 02:46:28,362 --> 02:46:30,764 TRIALS IN THE BACKGROUND OR DOT 3763 02:46:30,764 --> 02:46:33,333 GOT BUT LOOKS MORE USER 3764 02:46:33,333 --> 02:46:33,667 FRIENDLY. 3765 02:46:33,667 --> 02:46:39,573 >> SO THEY LEARNED A LESSON 3766 02:46:39,573 --> 02:46:49,716 PERHAPS. 3767 02:46:50,350 --> 02:46:53,120 >> RESEARCH MATCH DOT GOV THE 3768 02:46:53,120 --> 02:46:55,589 PURPOSE IS TO BE A PUBLIC 3769 02:46:55,589 --> 02:46:56,523 LISTING OF TRIALS. 3770 02:46:56,523 --> 02:46:57,991 IT'S NOT THE MOST USER FRIENDLY 3771 02:46:57,991 --> 02:46:59,793 BECAUSE YOU HAVE TO PUT IN A LOT 3772 02:46:59,793 --> 02:47:02,095 OF WORDS AND HOW ITS COMES UP IS 3773 02:47:02,095 --> 02:47:02,696 FUNCTIONAL BUT WOULD BE MORE 3774 02:47:02,696 --> 02:47:07,601 USER FRIENDLY. 3775 02:47:07,601 --> 02:47:08,168 THANK YOU. 3776 02:47:08,168 --> 02:47:10,137 >> JOIN ME IN THANKING 3777 02:47:10,137 --> 02:47:10,470 DR. LANGFORD. 3778 02:47:10,470 --> 02:47:11,004 THANK YOU ALL. 3779 02:47:11,004 --> 02:47:14,541 THAT'S IT FOR US TODAY. 3780 02:47:14,541 --> 02:47:16,543 WE'LL BE BACK NEXT WEEK WITH A 3781 02:47:16,543 --> 02:47:18,679 GROUP OF FOLKS TALKING ABOUT 3782 02:47:18,679 --> 02:47:20,013 GENETICS. 3783 02:47:20,013 --> 02:47:21,148 IT'S GENETICS DAY NEXT WEEK. 3784 02:47:21,148 --> 02:47:31,325 THANK YOU.