1 00:00:05,280 --> 00:00:08,000 >> WELCOME, EVERYONE, TO OUR 2 00:00:08,000 --> 00:00:10,480 INAUGURAL INCLUDE CLINICAL 3 00:00:10,480 --> 00:00:12,680 TRIALS SEMINAR SERIES, FIRST 4 00:00:12,680 --> 00:00:18,360 WEBINAR ON ASSENT AND CONSENT. 5 00:00:18,360 --> 00:00:19,720 NEXT SLIDE. 6 00:00:19,720 --> 00:00:20,720 THANK YOU. 7 00:00:20,720 --> 00:00:25,040 WE HAVE THREE GREAT 8 00:00:25,040 --> 00:00:27,760 PRESENTATIONS, AS WELL AS THE 9 00:00:27,760 --> 00:00:30,280 INDIVIDUAL FROM THE COMMUNITY 10 00:00:30,280 --> 00:00:31,640 GIVING HIS PERSPECTIVE ON 11 00:00:31,640 --> 00:00:36,160 RESEARCH IN DOWN SYNDROME. 12 00:00:36,160 --> 00:00:42,360 I'M DR. LAURIE RYAN, WITH 13 00:00:42,360 --> 00:00:43,280 COLLEAGUE ERIKA TARVER, FROM 14 00:00:43,280 --> 00:00:45,320 NATIONAL INSTITUTE ON AGING. 15 00:00:45,320 --> 00:00:49,280 ERIKA WILL GO OVER THE LOW JUST 16 00:00:49,280 --> 00:00:49,480 TIGS. 17 00:00:49,480 --> 00:00:51,520 >> THANK YOU, LAURIE. 18 00:00:51,520 --> 00:00:53,840 WELCOME TO THE PARTICIPANTS, 19 00:00:53,840 --> 00:00:56,800 WE'RE EXCITED FOR TODAY'S 20 00:00:56,800 --> 00:00:58,520 SESSION AND WEBINAR. 21 00:00:58,520 --> 00:00:59,960 TODAY'S SESSION WILL BE 22 00:00:59,960 --> 00:01:00,520 RECORDED. 23 00:01:00,520 --> 00:01:04,960 AND IT WILL ALSO BE STREAMED 24 00:01:04,960 --> 00:01:05,360 THROUGH VIDEOCAST. 25 00:01:05,360 --> 00:01:07,080 IF YOU'RE NOT ABLE TO 26 00:01:07,080 --> 00:01:08,280 PARTICIPATE FOR THE DURATION OF 27 00:01:08,280 --> 00:01:10,480 THE VIDEOCAST OR FOR TODAY'S 28 00:01:10,480 --> 00:01:13,280 WEBINAR, YOU CAN VIEW IT AS A 29 00:01:13,280 --> 00:01:15,720 FOLLOW-UP ON VIDEOCAST. 30 00:01:15,720 --> 00:01:19,320 ALSO IF YOU ARE IN NEED OF 31 00:01:19,320 --> 00:01:20,840 SPANISH INTERPRETATION, LET US 32 00:01:20,840 --> 00:01:21,360 KNOW. 33 00:01:21,360 --> 00:01:24,240 WE HAVE SEVERAL COLLEAGUES TO 34 00:01:24,240 --> 00:01:25,080 ASSIST WITH THAT. 35 00:01:25,080 --> 00:01:35,560 I WILL TURN IT OVER TO YOU, 36 00:01:42,360 --> 00:01:42,560 LAURIE. 37 00:01:42,560 --> 00:01:43,640 >> RECORDING IN PROGRESS. 38 00:01:43,640 --> 00:01:46,280 >> I'M GOING TO INTRODUCE THE 39 00:01:46,280 --> 00:01:46,920 SPEAKERS. 40 00:01:46,920 --> 00:01:47,800 DR. SHARON KRINSKY McHALE, 41 00:01:47,800 --> 00:01:50,360 HEAD OF LABORATORY OF COGNITION 42 00:01:50,360 --> 00:01:57,320 AND DEVELOPMENT AT THE NEW YORK 43 00:01:57,320 --> 00:02:01,720 STATE INSTITUTE AND COLUMBIA 44 00:02:01,720 --> 00:02:02,480 UNIVERSITY, DR. DAN HOLMES, 45 00:02:02,480 --> 00:02:04,480 UNIVERSITY OF ARIZONA COLLEGE OF 46 00:02:04,480 --> 00:02:06,400 MEDICINE IN TUCSON, DR. ANN 47 00:02:06,400 --> 00:02:09,400 COHEN, ASSOCIATE PROFESSOR OF 48 00:02:09,400 --> 00:02:10,200 PSYCHIATRY, UNIVERSITY OF 49 00:02:10,200 --> 00:02:14,560 PITTSBURGH SCHOOL OF MEDICINE. 50 00:02:14,560 --> 00:02:18,960 SHARON, OVER TO YOU TO GET 51 00:02:18,960 --> 00:02:19,840 STARTED. 52 00:02:19,840 --> 00:02:20,800 >> OKAY. 53 00:02:20,800 --> 00:02:24,080 I THINK I'M UNMUTED. 54 00:02:24,080 --> 00:02:30,240 SO, HISTORICALLY MANY ADULTS 55 00:02:30,240 --> 00:02:32,560 WITH INTELLECTUAL DISABILITY ARE 56 00:02:32,560 --> 00:02:33,240 PRESUMED INCOMPETENT, RESTRICTED 57 00:02:33,240 --> 00:02:34,280 IN OPPORTUNITIES TO MAKE 58 00:02:34,280 --> 00:02:36,800 DECISIONS FOR THEMSELVES 59 00:02:36,800 --> 00:02:37,880 INCLUDING DECISION OF 60 00:02:37,880 --> 00:02:48,360 PARTICIPATING IN RESEARCH. 61 00:02:48,680 --> 00:02:51,040 ALTERNATIVELY, RESULTING IN 62 00:02:51,040 --> 00:02:52,160 ABUSES SUCH AS WILLOW BROOK 63 00:02:52,160 --> 00:02:55,640 STATE SCHOOL, I THINK IT'S AN 64 00:02:55,640 --> 00:02:59,000 IMPORTANT HISTORY LESSON, TO 65 00:02:59,000 --> 00:03:02,440 REMIND US THE MEDICAL DIRECTOR 66 00:03:02,440 --> 00:03:04,720 HERE AT WILLOW BROOK BEGAN THE 67 00:03:04,720 --> 00:03:06,720 HEPATITIS STUDY IN EFFORT TO 68 00:03:06,720 --> 00:03:12,280 UNDERSTAND HOW THE DISEASE 69 00:03:12,280 --> 00:03:14,080 FUNCTIONS AND UTILIZED RESIDENTS 70 00:03:14,080 --> 00:03:15,600 OF WILLOW BROOK, RECEIVED 71 00:03:15,600 --> 00:03:17,240 INFORMED CONSENT THE PARENTS 72 00:03:17,240 --> 00:03:18,960 WERE TOLD THAT THIS WAS 73 00:03:18,960 --> 00:03:21,720 SOMETHING THAT COULD POTENTIALLY 74 00:03:21,720 --> 00:03:22,920 BENEFIT THEIR CHILDREN AND 75 00:03:22,920 --> 00:03:24,000 THEREFORE RECEIVED THEIR FULL 76 00:03:24,000 --> 00:03:24,440 SUPPORT. 77 00:03:24,440 --> 00:03:29,480 WHAT HE DID WAS TO ADMINISTER 78 00:03:29,480 --> 00:03:38,040 THE VIRUS TO UNINFECTED DISEASE, 79 00:03:38,040 --> 00:03:40,640 RESULTING IN BREAKTHROUGH IN 80 00:03:40,640 --> 00:03:43,280 CLASSIFYING STRAINS A AND B AND 81 00:03:43,280 --> 00:03:48,120 THIS LED TO DEVELOPMENT OF 82 00:03:48,120 --> 00:03:48,440 VACCINATIONS. 83 00:03:48,440 --> 00:03:53,800 HE WAS HONORED AS A MEDICAL HERO 84 00:03:53,800 --> 00:03:55,120 BUT SERENDIPITOUSLY, THIS WAS IN 85 00:03:55,120 --> 00:03:56,840 A TIME IN SOCIAL AND CIVIL 86 00:03:56,840 --> 00:03:58,160 HISTORY PRIOR TO CIVIL RIGHTS 87 00:03:58,160 --> 00:04:01,680 FOR ALL PEOPLE INCLUDING THOSE, 88 00:04:01,680 --> 00:04:03,200 ESPECIALLY WITH INTELLECTUAL 89 00:04:03,200 --> 00:04:03,760 DEVELOPMENTAL DISABILITIES. 90 00:04:03,760 --> 00:04:07,680 AS A RESULT OF THIS STUDY, WE 91 00:04:07,680 --> 00:04:12,280 NOW HAVE THE WILLOWBROOK DECREE, 92 00:04:12,280 --> 00:04:14,280 WHICH SAYS THAT RESIDENTS ARE 93 00:04:14,280 --> 00:04:17,320 PROTECTED OR PARTICIPANTS ARE 94 00:04:17,320 --> 00:04:17,960 PROTECTED UNDER EIGHTH AND 14TH 95 00:04:17,960 --> 00:04:22,240 AMENDMENT TO BE FREE FROM 96 00:04:22,240 --> 00:04:24,640 UNETHICAL EXPERIMENTATION AND 97 00:04:24,640 --> 00:04:28,080 EXPOSURE TO HARMFUL ENVIRONMENTS 98 00:04:28,080 --> 00:04:31,840 WITHOUT FULL INFORMED CONSENT. 99 00:04:31,840 --> 00:04:33,840 SO, WHAT I'D LIKE TO DO TODAY IS 100 00:04:33,840 --> 00:04:36,000 HELP YOU GAIN BETTER 101 00:04:36,000 --> 00:04:39,200 UNDERSTANDING OF OVERALL 102 00:04:39,200 --> 00:04:40,960 PERCEPTIONS, ATTITUDES, 103 00:04:40,960 --> 00:04:42,160 IMPEDIMENTS, ASSOCIATED WITH 104 00:04:42,160 --> 00:04:43,800 ENROLLING INDIVIDUALS WITH DOWN 105 00:04:43,800 --> 00:04:47,880 SYNDROME OR OTHER INTELLECTUAL 106 00:04:47,880 --> 00:04:49,160 DISABILITIES, INTO CLINICAL 107 00:04:49,160 --> 00:04:50,600 TRIALS. 108 00:04:50,600 --> 00:04:53,400 SO SOME BASIC CONSIDERATIONS, 109 00:04:53,400 --> 00:04:55,400 INDIVIDUALS WITH ID/DD ARE 110 00:04:55,400 --> 00:04:57,800 POTENTIALLY AT RISK FOR 111 00:04:57,800 --> 00:05:01,080 EXPLOITATION IN THE RESEARCH 112 00:05:01,080 --> 00:05:03,560 PROJECT BECAUSE OF RELATIVE 113 00:05:03,560 --> 00:05:08,960 SOCIAL POWERLESSES NESS AND 114 00:05:08,960 --> 00:05:10,800 OFTEN PERCEIVED AS LACKING 115 00:05:10,800 --> 00:05:13,560 CAPACITY TO PROVIDE INFORMED 116 00:05:13,560 --> 00:05:14,040 CONSENT. 117 00:05:14,040 --> 00:05:16,160 BUT AVOIDING THESE ISSUES VIA 118 00:05:16,160 --> 00:05:17,920 BLANKET EXCLUSION FOR RESEARCH 119 00:05:17,920 --> 00:05:19,800 DENIES THEM THE OPPORTUNITY TO 120 00:05:19,800 --> 00:05:23,400 CONTRIBUTE TO AND TO BENEFIT 121 00:05:23,400 --> 00:05:24,640 FROM RESEARCH. 122 00:05:24,640 --> 00:05:26,040 KATHERINE MCDONALD IS A 123 00:05:26,040 --> 00:05:27,560 RESEARCHER IN OREGON THAT DOES 124 00:05:27,560 --> 00:05:30,720 STUDIES WHICH LOOKS AT THIS 125 00:05:30,720 --> 00:05:32,160 INFORMED CONSENT PROCEDURE. 126 00:05:32,160 --> 00:05:33,800 SHE CALLS ALL THESE PEOPLE ON 127 00:05:33,800 --> 00:05:39,920 THIS SLIDE THE GATE KEEPERS OF 128 00:05:39,920 --> 00:05:40,240 SCIENCE. 129 00:05:40,240 --> 00:05:44,520 THE KNOWLEDGE BASE IS SHAPED BY 130 00:05:44,520 --> 00:05:46,400 240ES THOSE WHO CONDUCT RESEARCH 131 00:05:46,400 --> 00:05:50,080 IN ID/DD AND CONSIDER ITS 132 00:05:50,080 --> 00:05:52,240 ETHICAL INTEGRITY AND WILL HAVE 133 00:05:52,240 --> 00:05:53,280 SUBSTANTIAL INFLUENCE, PLAYING 134 00:05:53,280 --> 00:05:55,120 MAJOR ROLES THAT AFFECT WHAT 135 00:05:55,120 --> 00:05:57,680 TOPICS ARE PURSUED AND HOW 136 00:05:57,680 --> 00:06:00,040 FINDINGS ARE INTERPRETED AND 137 00:06:00,040 --> 00:06:08,680 PRESENTED TO FORM SCIENTIFIC RE. 138 00:06:08,680 --> 00:06:09,760 INTELLECTUAL DISABILITY 139 00:06:09,760 --> 00:06:10,560 RESEARCH, THE PORTRAYAL OF 140 00:06:10,560 --> 00:06:13,240 INDIVIDUALS, WE'RE THE ONES THAT 141 00:06:13,240 --> 00:06:17,640 WRITE THE SCIENTIFIC LITERATURE. 142 00:06:17,640 --> 00:06:19,600 FURTHER, REGULATIONS IMPOSED BY 143 00:06:19,600 --> 00:06:21,520 FDA, IRB COMMITTEES, STATE 144 00:06:21,520 --> 00:06:23,600 GOVERNMENT, THOSE AGENCIES THAT 145 00:06:23,600 --> 00:06:25,360 PROVIDE SERVICES TO PEOPLE WITH 146 00:06:25,360 --> 00:06:29,960 INTELLECTUAL AND DEVELOPMENTAL 147 00:06:29,960 --> 00:06:30,720 DISABILITIES AND DECIDE, SHAPE 148 00:06:30,720 --> 00:06:33,120 WHICH INDIVIDUALS ARE ALLOWED TO 149 00:06:33,120 --> 00:06:35,040 PARTICIPATE IN RESEARCH, AND 150 00:06:35,040 --> 00:06:37,240 TERMS OF THE PARTICIPATION. 151 00:06:37,240 --> 00:06:38,080 THAT ETHICS COMMITTEE SOMETIMES 152 00:06:38,080 --> 00:06:42,360 GO TO SUCH LENGTHS TO AVOID HARM 153 00:06:42,360 --> 00:06:43,640 THAT THEIR REQUIREMENTS 154 00:06:43,640 --> 00:06:45,280 DISCOURAGE RESEARCHERS FROM 155 00:06:45,280 --> 00:06:47,040 ATTEMPTING TO CONDUCT RESEARCH 156 00:06:47,040 --> 00:06:49,000 WITH PEOPLE WITH INTELLECTUAL 157 00:06:49,000 --> 00:06:51,680 DISABILITIES, SO AS SUCH, THESE 158 00:06:51,680 --> 00:06:53,960 ATTITUDES OF THESE GATE KEEPERS 159 00:06:53,960 --> 00:06:55,000 TOWARDS RESEARCH IN CLINICAL 160 00:06:55,000 --> 00:06:57,120 TRIALS IS LIKELY TO BE AN 161 00:06:57,120 --> 00:06:59,080 IMPORTANT FACTOR IN OUR WORK 162 00:06:59,080 --> 00:07:00,480 STARTING CLINICAL TRIALS WITH 163 00:07:00,480 --> 00:07:02,200 INDIVIDUALS WITH DOWN SYNDROME. 164 00:07:02,200 --> 00:07:05,120 SO, WHAT ARE THE GATEKEEPERS? 165 00:07:05,120 --> 00:07:07,600 AT THE FEDERAL LEVEL, FOR 166 00:07:07,600 --> 00:07:08,920 INSTANCE, U.S. DEPARTMENT OF 167 00:07:08,920 --> 00:07:10,400 HEALTH AND HUMAN SERVICES HAS 168 00:07:10,400 --> 00:07:15,960 SOUGHT TO ENSURE GREATER 169 00:07:15,960 --> 00:07:17,520 REPRESENTATIVENESS AND RELIANCE 170 00:07:17,520 --> 00:07:18,800 OF RESEARCH BY MANDATING 171 00:07:18,800 --> 00:07:22,320 INCLUSION OF WOMEN AND RACIAL 172 00:07:22,320 --> 00:07:31,720 MINORITIES, THERE'S NO 173 00:07:31,720 --> 00:07:34,880 CORRESPONDING MANDATES FOR ID/ 174 00:07:34,880 --> 00:07:35,280 DD. 175 00:07:35,280 --> 00:07:35,880 THE WILLOWBROOK INSTITUTE 176 00:07:35,880 --> 00:07:43,120 STARTED THAT MOVEMENT NO 177 00:07:43,120 --> 00:07:46,560 RECOGNIZE UNALIENABLE RIGHTS AND 178 00:07:46,560 --> 00:07:48,560 PROMPTED THE 1993 PERMANENT 179 00:07:48,560 --> 00:07:49,760 INJUNCTIONRY REPRESENTED THE 180 00:07:49,760 --> 00:07:51,320 CURRENT STANDARDS OF SERVICE FOR 181 00:07:51,320 --> 00:07:53,080 WHAT THEY CALLED "CLASS 182 00:07:53,080 --> 00:07:55,000 MEMBERS," OR INDIVIDUALS THAT 183 00:07:55,000 --> 00:07:56,240 RESIDED AT WILLOWBROOK. 184 00:07:56,240 --> 00:07:59,200 AT THIS POINT NO PHYSICALLY 185 00:07:59,200 --> 00:08:01,040 INTRUSIVE CHEMICAL OR BIOMEDICAL 186 00:08:01,040 --> 00:08:04,320 RESEARCH OR EXPERIMENTATION CAN 187 00:08:04,320 --> 00:08:06,360 BE PERFORMED WITH WILLOWBROOK 188 00:08:06,360 --> 00:08:07,400 CLASS MEMBERS. 189 00:08:07,400 --> 00:08:11,080 SOME OF THEIR SPECIFICS 190 00:08:11,080 --> 00:08:12,680 REGARDING BEHAVIOR MODIFICATION 191 00:08:12,680 --> 00:08:14,520 AND RESEARCH AND HAZARDOUS AND 192 00:08:14,520 --> 00:08:16,280 EXPERIMENTAL TREATMENT, THEY 193 00:08:16,280 --> 00:08:20,680 SAID THEY RECOGNIZED POSSIBILITY 194 00:08:20,680 --> 00:08:24,480 SUCH RESEARCH OR EXPERIMENTATION 195 00:08:24,480 --> 00:08:26,760 UNDER SAFEGUARDS MAY BE 196 00:08:26,760 --> 00:08:28,840 APPROPRIATE BUT HAVE TO BE 197 00:08:28,840 --> 00:08:29,640 CONDUCTED ONLY AFTER APPROVAL 198 00:08:29,640 --> 00:08:32,600 HAS BEEN OBTAINED FROM THE 199 00:08:32,600 --> 00:08:37,400 INDIVIDUAL, PARENT, GUARDIAN, OR 200 00:08:37,400 --> 00:08:40,680 THREE-PERSON SPECIAL COMMITTEE. 201 00:08:40,680 --> 00:08:42,360 IN NEW JERSEY WE RECRUIT 202 00:08:42,360 --> 00:08:45,480 INDIVIDUALS FROM NEW JERSEY IN 203 00:08:45,480 --> 00:08:47,120 OUR NEW YORK COHORT, UP IN THE 204 00:08:47,120 --> 00:08:55,760 TWEL -- UNTIL 2012 THEY COULD 205 00:08:55,760 --> 00:09:01,040 NOT PARTICIPATE WITHOUT A 206 00:09:01,040 --> 00:09:05,760 GUARDIAN AD LITEM, TO PROTECT A 207 00:09:05,760 --> 00:09:09,560 CHILD'S OR ADULTS INTEREST IN A 208 00:09:09,560 --> 00:09:13,080 SINGLE INSTANCE, COURT 209 00:09:13,080 --> 00:09:15,800 PROCEEDING OR LITIGATION. 210 00:09:15,800 --> 00:09:17,880 WE NOTICED ABOUT 2011, THE 211 00:09:17,880 --> 00:09:19,480 SENATE PASSED A BILL WHICH WAS 212 00:09:19,480 --> 00:09:23,000 SUPPOSED TO ELIMINATE THE 213 00:09:23,000 --> 00:09:25,320 CONFUSION AROUND THIS, AND TO 214 00:09:25,320 --> 00:09:26,520 PERMIT OTHERS TO GIVE CONSENT 215 00:09:26,520 --> 00:09:29,040 FOR RESEARCH, OTHER THAN A 216 00:09:29,040 --> 00:09:30,920 GUARDIAN AD LITEM AND ACTUALLY 217 00:09:30,920 --> 00:09:32,240 OUR GROUP WAS INSTRUMENTAL IN 218 00:09:32,240 --> 00:09:34,320 GETTING IT PASSED IN THE 219 00:09:34,320 --> 00:09:35,520 ASSEMBLY SO IT NEEDED ASSEMBLY 220 00:09:35,520 --> 00:09:39,080 AND SENATE TO PASS IN ORDER FOR 221 00:09:39,080 --> 00:09:40,440 IT TO BECOME LAW. 222 00:09:40,440 --> 00:09:42,080 HOWEVER, WE DO HAVE TO GO 223 00:09:42,080 --> 00:09:43,520 THROUGH ANY KIND OF MEDICAL 224 00:09:43,520 --> 00:09:48,320 RESEARCH HAS TO BE APPROVED BY 225 00:09:48,320 --> 00:09:50,040 THE INTERDISCIPLINARY RESEARCH 226 00:09:50,040 --> 00:09:51,280 COMMITTEE APPOINTED BY NEW 227 00:09:51,280 --> 00:09:52,600 JERSEY DIVISION OF DEVELOPMENTAL 228 00:09:52,600 --> 00:09:52,920 DISABILITIES. 229 00:09:52,920 --> 00:09:55,120 SO THIS IS ONE OF THE GROUPS 230 00:09:55,120 --> 00:09:57,520 THAT PROVIDES SERVICES FOR 231 00:09:57,520 --> 00:10:00,240 INDIVIDUALS IN NEW JERSEY THAT 232 00:10:00,240 --> 00:10:01,880 HAVE DEVELOPMENTAL DISABILITIES. 233 00:10:01,880 --> 00:10:04,320 AS IT CURRENTLY STANDS, THEY CAN 234 00:10:04,320 --> 00:10:05,720 IMPOSE ANY LIMITATIONS ON THE 235 00:10:05,720 --> 00:10:07,160 RESEARCH AND WHAT THEY HAVE DONE 236 00:10:07,160 --> 00:10:10,800 THUS FAR IS ONLY TO APPROVE OUR 237 00:10:10,800 --> 00:10:11,960 MINIMAL RISK PROCEDURES AND SO 238 00:10:11,960 --> 00:10:15,120 AT THIS POINT IN TIME NEW JERSEY 239 00:10:15,120 --> 00:10:16,720 RESIDENTS CANNOT PARTICIPATE IN 240 00:10:16,720 --> 00:10:21,600 OUR PROCEDURES OF PET SCANS AND 241 00:10:21,600 --> 00:10:23,240 LUMBAR PUNCTURES THOUGH WE HAVE 242 00:10:23,240 --> 00:10:24,520 AN APPLICATION TO HAVE THEM 243 00:10:24,520 --> 00:10:25,400 RECONSIDER THIS. 244 00:10:25,400 --> 00:10:27,040 THE LAST STATE, THIS IS JUST TO 245 00:10:27,040 --> 00:10:29,920 SHOW HOW THE STATES HAVE 246 00:10:29,920 --> 00:10:34,720 DIFFERENT RULES AND REGULATIONS, 247 00:10:34,720 --> 00:10:37,880 IN NEW MEXICO A DOCTOR WAS 248 00:10:37,880 --> 00:10:40,280 LEUKEMIA PROGRAM DIRECTOR AND 249 00:10:40,280 --> 00:10:41,640 MASTER CYTOSIS PROGRAM LEADER AT 250 00:10:41,640 --> 00:10:43,920 THE UNIVERSITY OF NEW MEXICO, 251 00:10:43,920 --> 00:10:46,600 AND SHE CONDUCTS CLINICAL TRIALS 252 00:10:46,600 --> 00:10:49,680 IN ACUTE AND CHRONIC LEUKEMIAS. 253 00:10:49,680 --> 00:10:51,080 AND WHEN SHE BECAME ACQUAINTED 254 00:10:51,080 --> 00:10:52,840 WITH GEORGE WHO CAME TO HER 255 00:10:52,840 --> 00:10:54,840 CLINIC AT THE UNIVERSITY OF NEW 256 00:10:54,840 --> 00:10:55,680 MEXICO CANCER CENTER, SHE 257 00:10:55,680 --> 00:10:58,080 THOUGHT HE WOULD BE AN EXCELLENT 258 00:10:58,080 --> 00:10:59,880 IDEAL CANDIDATE FOR NATIONAL 259 00:10:59,880 --> 00:11:01,080 REGISTRY STUDY. 260 00:11:01,080 --> 00:11:02,600 HE HAD BEEN SUCCESSFULLY TREATED 261 00:11:02,600 --> 00:11:06,120 FOR LEUKEMIA IN HIS 30s, LATER 262 00:11:06,120 --> 00:11:08,520 DEVELOPED A SECONDARY LEUKEMIA, 263 00:11:08,520 --> 00:11:12,440 AND SHE WAS INTERESTED IN 264 00:11:12,440 --> 00:11:15,880 GETTING HIS BONE MARROW TO A 265 00:11:15,880 --> 00:11:19,480 BIOBANK TO IDENTIFY MOLECULAR 266 00:11:19,480 --> 00:11:20,360 MECHANISM UNDERLYING THIS IS 267 00:11:20,360 --> 00:11:21,520 CANCER. 268 00:11:21,520 --> 00:11:23,840 GEORGE WAS NOT ELIGIBLE BECAUSE 269 00:11:23,840 --> 00:11:25,800 HIS INTELLECTUAL DISABILITY THAT 270 00:11:25,800 --> 00:11:27,760 WAS RELATED TO HIS DOWN SYNDROME 271 00:11:27,760 --> 00:11:32,280 MADE HIM UNABLE TO COMPLETE THE 272 00:11:32,280 --> 00:11:33,920 STANDARDIZED QUALITY OF LIFE 273 00:11:33,920 --> 00:11:36,520 MEASURE THAT WAS REQUIRED OF THE 274 00:11:36,520 --> 00:11:37,320 PROTOCOL. 275 00:11:37,320 --> 00:11:40,360 AND ALL SHE COULD NOT ENROLL HIM 276 00:11:40,360 --> 00:11:41,560 IN AN INTERVENTION TRIAL EITHER 277 00:11:41,560 --> 00:11:43,840 EVEN THOUGH HIS FATHER AND HIS 278 00:11:43,840 --> 00:11:46,040 SISTER WHO WERE HIS LEGAL 279 00:11:46,040 --> 00:11:48,000 GUARDIANS WANTED HIM TO 280 00:11:48,000 --> 00:11:50,200 PARTICIPATE. 281 00:11:50,200 --> 00:11:51,720 IN THE PEDIATRIC SETTING, 282 00:11:51,720 --> 00:11:53,680 PARENTS MAKE THE DECISIONS, WHEN 283 00:11:53,680 --> 00:11:57,440 WE ARE TALKING ABOUT THE ADULTS 284 00:11:57,440 --> 00:11:58,640 IF PATIENTS ARE UNABLE TO 285 00:11:58,640 --> 00:12:04,720 CONSENT OR FULFILL PROTOCOL 286 00:12:04,720 --> 00:12:06,280 REQUIREMENTS THEY CANNOT BE 287 00:12:06,280 --> 00:12:08,120 ENROLLED EVEN IF TREATMENT IS 288 00:12:08,120 --> 00:12:09,560 POTENTIALLY LIFE SAVING. 289 00:12:09,560 --> 00:12:14,600 A CHALLENGE FOR DEVELOPMENTAL 290 00:12:14,600 --> 00:12:15,480 DISABILITY RESEARCH IS 291 00:12:15,480 --> 00:12:17,680 RESPECTING RIGHTS TO BE TREATED 292 00:12:17,680 --> 00:12:18,800 AS AUTONOMOUS MEMBERS OF 293 00:12:18,800 --> 00:12:27,000 SOCIETY, AND THE NEED TO ENSURE 294 00:12:27,000 --> 00:12:28,640 THAT ILL-FORMED OR INCOMPETENT 295 00:12:28,640 --> 00:12:34,520 DECISIONS WILL NOT PLACE THEIR 296 00:12:34,520 --> 00:12:36,080 WELFARE IN JEOPARDY. 297 00:12:36,080 --> 00:12:37,280 >> WOULD YOU MIND SLOWING YOUR 298 00:12:37,280 --> 00:12:38,680 SPACE DOWN? 299 00:12:38,680 --> 00:12:40,640 WE HAVE COLLEAGUES PROVIDING 300 00:12:40,640 --> 00:12:41,920 INTERPRETATION. 301 00:12:41,920 --> 00:12:44,040 >> I GO INTO MY NEW YORK MODE OF 302 00:12:44,040 --> 00:12:44,320 SPEAKING. 303 00:12:44,320 --> 00:12:44,800 >> THAT'S OKAY. 304 00:12:44,800 --> 00:12:48,760 THANK YOU, I APPRECIATE IT. 305 00:12:48,760 --> 00:12:50,560 >> SO, IT'S TAKEN ME TO THE 306 00:12:50,560 --> 00:12:53,600 15th SLIDE TO GET TO INFORMED 307 00:12:53,600 --> 00:12:56,000 CONSENT, INFORMED CONSENT, THE 308 00:12:56,000 --> 00:12:58,600 INDIVIDUAL MUST HAVE CAPACITY TO 309 00:12:58,600 --> 00:13:02,280 PROVIDE CONSENT, CONSENT MUST BE 310 00:13:02,280 --> 00:13:04,440 GIVEN VOLUNTARILY, CONSENT MUST 311 00:13:04,440 --> 00:13:06,280 BE RELATED TO PROPOSED 312 00:13:06,280 --> 00:13:09,560 INVESTIGATION, TREATMENT, TO BE 313 00:13:09,560 --> 00:13:10,520 INFORMED BY ADEQUATE DISCLOSURE 314 00:13:10,520 --> 00:13:15,240 AND CONSENT MUST NOT BE OBTAINED 315 00:13:15,240 --> 00:13:17,440 THROUGH FRAUD, COERCION, OR 316 00:13:17,440 --> 00:13:17,840 MISREPRESENTATION. 317 00:13:17,840 --> 00:13:22,160 SO THAT GETS US TO THIS ISSUE OF 318 00:13:22,160 --> 00:13:26,200 WHAT IS THE DEFINITION OF 319 00:13:26,200 --> 00:13:26,720 CAPACITY. 320 00:13:26,720 --> 00:13:28,760 THE TERMS, CAPACITY, COMPETENCE, 321 00:13:28,760 --> 00:13:30,480 ARE OFTEN USED INTERCHANGEABLY 322 00:13:30,480 --> 00:13:32,800 BUT THEY DO HAVE DIFFERENT 323 00:13:32,800 --> 00:13:36,560 MEANINGS AND IMPLICATIONS FOR 324 00:13:36,560 --> 00:13:37,920 PEOPLE WITH DEVELOPMENTAL 325 00:13:37,920 --> 00:13:39,120 DISABILITIES. 326 00:13:39,120 --> 00:13:40,880 COMPETENCY IS A GLOBAL 327 00:13:40,880 --> 00:13:41,680 ASSESSMENT. 328 00:13:41,680 --> 00:13:44,480 AND A LEGAL DETERMINATION, WHILE 329 00:13:44,480 --> 00:13:46,560 CAPACITY IS A FUNCTIONAL 330 00:13:46,560 --> 00:13:49,960 ASSESSMENT REGARDING A SPECIFIC 331 00:13:49,960 --> 00:13:50,560 DECISION. 332 00:13:50,560 --> 00:13:52,520 IT REFERS TO MENTAL ABILITY TO 333 00:13:52,520 --> 00:13:56,680 MAKE A PARTICULAR DECISION, AT A 334 00:13:56,680 --> 00:13:58,160 PARTICULAR TIME, QUESTION AND 335 00:13:58,160 --> 00:14:00,720 DECISION SPECIFIC, SHOULD BE 336 00:14:00,720 --> 00:14:02,480 DOCUMENTED, RELATIVE TO EACH 337 00:14:02,480 --> 00:14:04,640 DECISION, CAN VARY ACCORDING TO 338 00:14:04,640 --> 00:14:06,280 SUPPORTS THAT ARE PROVIDED, AND 339 00:14:06,280 --> 00:14:08,480 CAN INVOLVE OTHERS WHO WILL HELP 340 00:14:08,480 --> 00:14:10,800 THE INDIVIDUAL TO MAKE THESE 341 00:14:10,800 --> 00:14:11,240 DECISIONS. 342 00:14:11,240 --> 00:14:12,360 IT'S IMPORTANT TO REMEMBER THAT 343 00:14:12,360 --> 00:14:14,240 IT'S NOT A STATIC ENTITY. 344 00:14:14,240 --> 00:14:16,920 SO AT ONE POINT IN TIME YOU MAY 345 00:14:16,920 --> 00:14:18,800 HAVE CAPACITY, AND LATER ON IN 346 00:14:18,800 --> 00:14:24,240 YOUR PARTICIPATION YOU MIGHT 347 00:14:24,240 --> 00:14:24,400 NOT. 348 00:14:24,400 --> 00:14:25,240 INDIVIDUALS WITH INTELLECTUAL 349 00:14:25,240 --> 00:14:27,160 DISABILITY WE KNOW IT AFFECTS A 350 00:14:27,160 --> 00:14:31,280 RANGE OF COGNITIVE AND ADAPTIVE 351 00:14:31,280 --> 00:14:32,360 ABILITIES. 352 00:14:32,360 --> 00:14:33,920 THERE IS SIGNIFICANT 353 00:14:33,920 --> 00:14:35,000 WITHIN-PERSON VARIABILITY, 354 00:14:35,000 --> 00:14:36,760 COGNITIVE LEVELS OF FUNCTIONING 355 00:14:36,760 --> 00:14:39,720 DO NOT DIRECTLY PREDICT 356 00:14:39,720 --> 00:14:42,440 DIFFERENCES IN LEVELS OF 357 00:14:42,440 --> 00:14:43,400 COMMUNICATIVE, INTERPERSONAL, OR 358 00:14:43,400 --> 00:14:45,200 ACTIVITIES OF DAILY LIVING IN 359 00:14:45,200 --> 00:14:46,960 ADAPTIVE FUNCTIONING. 360 00:14:46,960 --> 00:14:48,640 THOSE WITH INTELLECTUAL 361 00:14:48,640 --> 00:14:51,160 DISABILITIES ALSO HAVE LIMITED 362 00:14:51,160 --> 00:14:53,280 EDUCATIONAL OPPORTUNITIES AND 363 00:14:53,280 --> 00:14:55,000 SOCIAL EXPERIENCES THAT MAY 364 00:14:55,000 --> 00:14:57,200 IMPACT THEIR ABILITY TO CONSENT 365 00:14:57,200 --> 00:14:58,080 FOR RESEARCH. 366 00:14:58,080 --> 00:15:01,320 SO WHO HAS AND DOES NOT HAVE 367 00:15:01,320 --> 00:15:01,760 CAPACITY? 368 00:15:01,760 --> 00:15:04,200 PERSONS 18 YEARS OF AGE AND 369 00:15:04,200 --> 00:15:05,960 OLDER ARE PRESUMED TO HAVE 370 00:15:05,960 --> 00:15:08,360 CAPACITY TO MAKE THEIR OWN 371 00:15:08,360 --> 00:15:09,880 DECISIONS UNTIL THEY ARE SHOWN 372 00:15:09,880 --> 00:15:12,560 NOT TO HAVE SUCH CAPACITY. 373 00:15:12,560 --> 00:15:14,800 HOWEVER, MINORS FOR THE MOST 374 00:15:14,800 --> 00:15:17,160 PART ARE DEEMED TO BE 375 00:15:17,160 --> 00:15:19,640 INCOMPETENT, AS A MATTER OF LAW, 376 00:15:19,640 --> 00:15:21,040 REGARDLESS OF DISABILITY, AND 377 00:15:21,040 --> 00:15:28,360 THEIR PARENTS ARE THE DECISION 378 00:15:28,360 --> 00:15:28,720 MAKERS. 379 00:15:28,720 --> 00:15:29,760 WHEN INFORMED CONSENT IS 380 00:15:29,760 --> 00:15:32,160 REQUIRED IT HAS TO COME WITH 381 00:15:32,160 --> 00:15:34,640 EXPLANATIONS OF THE REASONS THAT 382 00:15:34,640 --> 00:15:36,920 WE'RE ASKING FOR THE CONSENT. 383 00:15:36,920 --> 00:15:39,960 WE HAVE TO PRESENT THE POTENTIAL 384 00:15:39,960 --> 00:15:42,960 BENEFIT OR THE INTENDED OUTCOME 385 00:15:42,960 --> 00:15:46,440 OF THE PROPOSED ACTION OR 386 00:15:46,440 --> 00:15:47,200 PARTICIPATION. 387 00:15:47,200 --> 00:15:49,200 WE HAVE TO BE -- INFORM THEM OF 388 00:15:49,200 --> 00:15:50,520 POTENTIAL RISKS TO THE 389 00:15:50,520 --> 00:15:51,920 INDIVIDUAL AND OTHERS, IF THE 390 00:15:51,920 --> 00:15:54,040 ACTION IS OR IS NOT IMPLEMENTED. 391 00:15:54,040 --> 00:15:56,080 WE HAVE TO GIVE THEM 392 00:15:56,080 --> 00:15:57,280 ALTERNATIVES TO ACTION THAT 393 00:15:57,280 --> 00:15:59,680 MIGHT BE USED AND THE REASONS 394 00:15:59,680 --> 00:16:01,720 FOR CHOOSING THE PLANNED ACTION 395 00:16:01,720 --> 00:16:03,760 AND FINALLY THE RIGHT TO 396 00:16:03,760 --> 00:16:06,920 DISAPPROVE THIS ACTION OR TO 397 00:16:06,920 --> 00:16:13,760 WITHDRAW APPROVAL AT ANY TIME. 398 00:16:13,760 --> 00:16:15,280 JOHNSON, IN OREGON, ACTUALLY 399 00:16:15,280 --> 00:16:18,880 CONDUCTED A STUDY WHICH ASSESSED 400 00:16:18,880 --> 00:16:20,840 UNDERSTANDING AND OBTAINING 401 00:16:20,840 --> 00:16:30,120 CONSENT FROM ADULTS WITH 402 00:16:30,120 --> 00:16:31,120 INTELLECTUAL DISABILITY, BETWEEN 403 00:16:31,120 --> 00:16:33,880 18 AND 65 YEARS, MILD OR 404 00:16:33,880 --> 00:16:35,520 MODERATE ID TO ANSWER QUESTIONS 405 00:16:35,520 --> 00:16:40,120 ABOUT THE KEY ASPECTS OF 406 00:16:40,120 --> 00:16:40,320 STUDIES. 407 00:16:40,320 --> 00:16:42,320 THEY WANTED TO IDENTIFY WAYS IN 408 00:16:42,320 --> 00:16:44,960 WHICH PEOPLE WHO PROVIDED 409 00:16:44,960 --> 00:16:45,720 APPROPRIATE ANSWERS FOR ALL 410 00:16:45,720 --> 00:16:47,160 QUESTIONS DIFFERED FROM THOSE 411 00:16:47,160 --> 00:16:48,800 WHO ARE DIFFICULTY WITH ONE OR 412 00:16:48,800 --> 00:16:49,760 MORE QUESTIONS. 413 00:16:49,760 --> 00:16:52,000 AND THEY WANTED TO EXAMINE 414 00:16:52,000 --> 00:16:54,040 PATTERNS OF RESPONSES TO SEE IF 415 00:16:54,040 --> 00:16:56,240 CERTAIN ISSUES WERE MORE 416 00:16:56,240 --> 00:16:58,080 DIFFICULT TO UNDERSTAND THAN 417 00:16:58,080 --> 00:16:58,320 OTHERS. 418 00:16:58,320 --> 00:17:03,040 SO THEY PILOTED A SHORT SET OF 419 00:17:03,040 --> 00:17:04,600 QUESTIONS, 133 PARTICIPANTS, 420 00:17:04,600 --> 00:17:07,160 AGAIN THEY HAD MILD TO MODERATE 421 00:17:07,160 --> 00:17:08,040 INTELLECTUAL DISABILITY. 422 00:17:08,040 --> 00:17:09,480 SO THEY ASKED, PLEASE TELL ME 423 00:17:09,480 --> 00:17:12,000 WHAT, IN YOUR OWN WORDS, WHAT IS 424 00:17:12,000 --> 00:17:12,760 THE STUDY ABOUT. 425 00:17:12,760 --> 00:17:14,640 WHAT WILL YOU BE DOING IF YOU 426 00:17:14,640 --> 00:17:16,040 TAKE PART IN THE STUDY? 427 00:17:16,040 --> 00:17:18,040 WHAT ARE THE RISKS OF BEING PART 428 00:17:18,040 --> 00:17:18,920 OF THE STUDY? 429 00:17:18,920 --> 00:17:21,400 WHEN I SAY YOU'RE TAKING PART IN 430 00:17:21,400 --> 00:17:22,720 THE STUDY IS COMPLETELY 431 00:17:22,720 --> 00:17:23,920 VOLUNTARY, WHAT DOES THAT MEAN 432 00:17:23,920 --> 00:17:24,360 TO YOU? 433 00:17:24,360 --> 00:17:26,320 WHEN I SAY YOUR ANSWERS WILL BE 434 00:17:26,320 --> 00:17:27,440 KEPT CONFIDENTIAL, WHAT DOES 435 00:17:27,440 --> 00:17:29,200 THAT MEAN TO YOU? 436 00:17:29,200 --> 00:17:31,840 AND WHAT CAN YOU DO IF YOU START 437 00:17:31,840 --> 00:17:34,480 THE STUDY BUT DECIDE THAT YOU 438 00:17:34,480 --> 00:17:36,680 DON'T WANT TO FINISH? 439 00:17:36,680 --> 00:17:38,080 THE RESULTS, TWO INDIVIDUALS 440 00:17:38,080 --> 00:17:40,240 WERE COMPLETELY UNABLE TO ANSWER 441 00:17:40,240 --> 00:17:42,600 ANY OF THESE QUESTIONS. 442 00:17:42,600 --> 00:17:45,480 57% CORRECTLY ANSWERED ALL SIX 443 00:17:45,480 --> 00:17:46,320 QUESTIONS. 444 00:17:46,320 --> 00:17:49,520 96% WERE ABLE TO APPROPRIATELY 445 00:17:49,520 --> 00:17:51,560 DESCRIBE THE STUDY, 88% WOULD 446 00:17:51,560 --> 00:17:53,160 SPECIFY WHAT IT MEANT, THAT THE 447 00:17:53,160 --> 00:17:56,000 DATA WOULD BE KEPT CONFIDENTIAL, 448 00:17:56,000 --> 00:17:58,800 93% WERE ABLE TO EXPLAIN WHAT 449 00:17:58,800 --> 00:18:00,000 VOLUNTARY PARTICIPATION MEANT. 450 00:18:00,000 --> 00:18:03,720 FOR THOSE UNABLE TO ANSWER ALL 451 00:18:03,720 --> 00:18:06,920 THE QUESTIONS, IT WAS IN THE 452 00:18:06,920 --> 00:18:08,600 AREA OF IDENTIFYING POTENTIAL 453 00:18:08,600 --> 00:18:13,680 RISKS THAT THEY THE MOST 454 00:18:13,680 --> 00:18:14,880 CHALLENGE. 455 00:18:14,880 --> 00:18:17,120 SO, CELIA FISHER IN FORDHAM 456 00:18:17,120 --> 00:18:18,320 UNIVERSITY DISCUSSED A GOODNESS 457 00:18:18,320 --> 00:18:21,080 EFFECT FOR INFORMED CONSENT TO 458 00:18:21,080 --> 00:18:24,400 RESEARCH ADULTS, WHICH RESEARCH 459 00:18:24,400 --> 00:18:26,280 INVOLVING ADULTS WITH 460 00:18:26,280 --> 00:18:26,800 INTELLECTUAL DISABILITIES. 461 00:18:26,800 --> 00:18:30,200 SHE INTRODUCED THIS RELATIONAL 462 00:18:30,200 --> 00:18:32,400 ETHICS FRAMEWORK THAT RECOGNIZES 463 00:18:32,400 --> 00:18:36,400 CONSENT, VULNERABLE, AGAIN IN 464 00:18:36,400 --> 00:18:38,880 TERMS OF GOODNESS OF FIT BETWEEN 465 00:18:38,880 --> 00:18:43,160 DECISION CAL CAPACITIES AND 466 00:18:43,160 --> 00:18:44,040 SPECIFIC CONTEXT. 467 00:18:44,040 --> 00:18:47,080 SHE SAID ALL PERSONS ARE UNIQUE 468 00:18:47,080 --> 00:18:49,080 INDIVIDUALS, THUS THE CONSENT 469 00:18:49,080 --> 00:18:52,920 PROCEDURE SHOULD BE BASED UPON 470 00:18:52,920 --> 00:18:54,880 AN UNDERSTANDING OF EACH 471 00:18:54,880 --> 00:18:57,360 PARTICIPANT'S STRENGTH AND 472 00:18:57,360 --> 00:18:58,760 WEAKNESSES, LIFE EXPERIENCES, 473 00:18:58,760 --> 00:19:00,360 AND SOME PRACTICAL CONCERNS. 474 00:19:00,360 --> 00:19:02,280 AND SUCH UNDERSTANDING CAN ONLY 475 00:19:02,280 --> 00:19:03,840 BE ACHIEVED THROUGH THE DEVELOP 476 00:19:03,840 --> 00:19:09,280 MEANT OF VALID AND INDIVIDUALLY 477 00:19:09,280 --> 00:19:11,280 SENSITIVE CONSENT, ASSESSMENT, 478 00:19:11,280 --> 00:19:12,600 AND ENHANCEMENT TECHNIQUES, TO 479 00:19:12,600 --> 00:19:15,320 ENSURE THAT THE CONSENT 480 00:19:15,320 --> 00:19:21,760 PROCEDURES REFLECT AN ETHIC AND 481 00:19:21,760 --> 00:19:22,520 MUTUAL OBLIGATION, RESPECT. 482 00:19:22,520 --> 00:19:23,520 AND WHAT'S SPOKEN ABOUT THESE 483 00:19:23,520 --> 00:19:27,040 DAYS IS THIS WHOLE IDEA OF 484 00:19:27,040 --> 00:19:29,360 AUTHORIZED RESEARCH 485 00:19:29,360 --> 00:19:30,160 REPRESENTATIVE. 486 00:19:30,160 --> 00:19:32,400 SO RESEARCH AS AN IRB MAY SET 487 00:19:32,400 --> 00:19:34,680 DIFFERENT CUT-POINTS FOR LEVEL 488 00:19:34,680 --> 00:19:36,120 OF CONSENT CAPACITY DEPENDING ON 489 00:19:36,120 --> 00:19:37,960 CAPACITY AND RISKS OF GIVEN 490 00:19:37,960 --> 00:19:40,600 STUDY, SO FOR LOWER RISK STUDIES 491 00:19:40,600 --> 00:19:41,880 SOME EVIDENCE OF UNDERSTANDING 492 00:19:41,880 --> 00:19:44,960 EVEN IF IT'S NOT COMPLETE MIGHT 493 00:19:44,960 --> 00:19:47,160 BE DEEMED SUFFICIENT FOR AN 494 00:19:47,160 --> 00:19:48,920 INDIVIDUAL TO PROVIDE INFORMED 495 00:19:48,920 --> 00:19:49,240 CONSENT. 496 00:19:49,240 --> 00:19:50,760 FOR RESEARCH THAT IS GREATER 497 00:19:50,760 --> 00:19:53,280 THAN MINIMAL RISK, SUCH AS 498 00:19:53,280 --> 00:19:58,480 CONDUCTING CLINICAL TRIALS, WITH 499 00:19:58,480 --> 00:19:59,520 THIS POPULATION, INCLUDING 500 00:19:59,520 --> 00:20:00,440 AUTHORIZED RESEARCH 501 00:20:00,440 --> 00:20:01,000 REPRESENTATIVE MAY BE ONE AL 502 00:20:01,000 --> 00:20:04,800 TERN ALTERNATIVE TO EXCLUSION. 503 00:20:04,800 --> 00:20:07,160 TODAY THERE ARE STILL FEW 504 00:20:07,160 --> 00:20:13,920 ETHICAL AND EMPIRICAL GUIDE 505 00:20:13,920 --> 00:20:15,880 POSTS TO CONSTRUCTING RESPECTFUL 506 00:20:15,880 --> 00:20:16,200 PROCEDURES. 507 00:20:16,200 --> 00:20:18,720 THERE'S AN OVERARCHING NEED TO 508 00:20:18,720 --> 00:20:21,800 BE FLEXIBLE, RESPOND TO NEEDS OF 509 00:20:21,800 --> 00:20:22,920 THE PARTICIPANT AND FACILITATE 510 00:20:22,920 --> 00:20:25,400 RESEARCH INCLUDING TO THE 511 00:20:25,400 --> 00:20:27,280 GREATEST POSSIBLE EXTENT WHILE 512 00:20:27,280 --> 00:20:29,520 MAINTAINING HIGH ETHICAL 513 00:20:29,520 --> 00:20:32,360 STANDARDS FOR PROTECTING 514 00:20:32,360 --> 00:20:35,920 RESEARCH PARTICIPANTS FROM HARM. 515 00:20:35,920 --> 00:20:37,640 JUST IN SUMMARY, YOU HAVE TO 516 00:20:37,640 --> 00:20:39,960 BECOME FAMILIAR WITH YOUR 517 00:20:39,960 --> 00:20:41,040 STATE'S POLICIES, AND 518 00:20:41,040 --> 00:20:44,440 REGULATIONS ON RESEARCH WITH THE 519 00:20:44,440 --> 00:20:46,720 ID POPULATION, IT'S IMPORTANT TO 520 00:20:46,720 --> 00:20:49,040 AHEAD OF TIME DISCUSS THE STUDY 521 00:20:49,040 --> 00:20:50,800 DESIGN, PROCEDURES, AND INFORMED 522 00:20:50,800 --> 00:20:52,960 CONSENT PROCESS WITH YOUR LOCAL 523 00:20:52,960 --> 00:20:53,600 IRBs. 524 00:20:53,600 --> 00:20:55,640 YOU ALSO HAVE TO CONTACT YOUR 525 00:20:55,640 --> 00:20:59,200 STATE'S LOCAL OFFICE FOR PEOPLE 526 00:20:59,200 --> 00:21:00,960 WITH DEVELOPMENTAL AND 527 00:21:00,960 --> 00:21:02,720 INTELLECTUAL DISABILITIES TO 528 00:21:02,720 --> 00:21:06,560 DETERMINE THEIR REGULATIONS, AND 529 00:21:06,560 --> 00:21:08,520 PARTICIPATION IN CLINICAL TRIALS 530 00:21:08,520 --> 00:21:09,320 NECESSITATES DEVELOPMENT OF 531 00:21:09,320 --> 00:21:11,920 METHODS TO IMPROVE THE INFORMED 532 00:21:11,920 --> 00:21:12,600 CONSENT PROCESS. 533 00:21:12,600 --> 00:21:14,800 WE MUST BE ABLE TO UNDERSTAND 534 00:21:14,800 --> 00:21:21,760 AND APPLY THE NUANCES OF 535 00:21:21,760 --> 00:21:23,080 INFORMED CONSENT. 536 00:21:23,080 --> 00:21:25,840 MAKING CLINICAL TRIAL ENROLLMENT 537 00:21:25,840 --> 00:21:27,240 PROCESS MORE ACCESSIBLE AND 538 00:21:27,240 --> 00:21:29,920 INCLUSIVE CAN BE A RELATIVELY 539 00:21:29,920 --> 00:21:30,640 STRAIGHTFORWARD PROCESS. 540 00:21:30,640 --> 00:21:32,600 IT'S REALLY A QUESTION OF 541 00:21:32,600 --> 00:21:35,240 FIGURING OUT HOW TO TAILOR YOUR 542 00:21:35,240 --> 00:21:36,000 PROCESS TO ACCOMMODATE THE 543 00:21:36,000 --> 00:21:37,960 POPULATION THAT YOU PLAN ON 544 00:21:37,960 --> 00:21:38,920 WORKING WITH. 545 00:21:38,920 --> 00:21:40,920 BUT IN ACTUALITY, IT CAN BE 546 00:21:40,920 --> 00:21:42,120 DIFFICULT TO DO. 547 00:21:42,120 --> 00:21:44,200 AND BECAUSE THE ISSUE AFFECTS 548 00:21:44,200 --> 00:21:46,600 SUCH A SMALL PERCENTAGE OF THE 549 00:21:46,600 --> 00:21:47,920 OVERALL POPULATION, IT CAN BE 550 00:21:47,920 --> 00:21:52,880 HARD TO GET PEOPLE TO CARE 551 00:21:52,880 --> 00:22:01,080 ENOUGH TO TRY OF WE HOPE TOOLS 552 00:22:01,080 --> 00:22:02,680 AND TRICKS BEING DEVELOPED GO 553 00:22:02,680 --> 00:22:04,320 VIRAL AND NEW INVESTIGATORS WILL 554 00:22:04,320 --> 00:22:06,400 LEARN FROM WORK OF EXPERIENCED 555 00:22:06,400 --> 00:22:08,040 INVESTIGATORS AND PASS ALONG 556 00:22:08,040 --> 00:22:12,560 THAT KNOWLEDGE TO A FEW MORE 557 00:22:12,560 --> 00:22:13,520 RESEARCHERS AND SO ON. 558 00:22:13,520 --> 00:22:16,360 IF YOU HAVE ANY QUESTIONS OR 559 00:22:16,360 --> 00:22:22,720 COMMENTS, PLEASE CONTACT ME. 560 00:22:22,720 --> 00:22:23,720 THIS IS MY INFORMATION. 561 00:22:23,720 --> 00:22:26,000 THANK YOU FOR INVITING ME TO 562 00:22:26,000 --> 00:22:28,040 PRESENT TODAY. 563 00:22:28,040 --> 00:22:28,760 >> THANK YOU, SHARON. 564 00:22:28,760 --> 00:22:31,040 BEFORE WE GO ON TO DAN WE'RE 565 00:22:31,040 --> 00:22:33,040 TAKING QUESTIONS THROUGH THE 566 00:22:33,040 --> 00:22:33,360 CHAT. 567 00:22:33,360 --> 00:22:34,480 WE'LL BE ADDRESSING QUESTIONS 568 00:22:34,480 --> 00:22:37,200 AFTER WE HAVE ALL OF OUR 569 00:22:37,200 --> 00:22:38,000 SPEAKERS GO. 570 00:22:38,000 --> 00:22:39,280 SO PLEASE PUT QUESTIONS IN THE 571 00:22:39,280 --> 00:22:40,560 CHAT IF YOU HAVE THEM. 572 00:22:40,560 --> 00:22:41,680 WE'LL BE TAKING THEM AND 573 00:22:41,680 --> 00:22:43,320 PROVIDING THEM TO THE SPEAKERS 574 00:22:43,320 --> 00:22:45,520 AFTER WE GET THROUGH ALL OF THE 575 00:22:45,520 --> 00:22:45,840 PRESENTATIONS. 576 00:22:45,840 --> 00:22:47,360 ALL RIGHT. 577 00:22:47,360 --> 00:22:48,560 THANK YOU, SHARON. 578 00:22:48,560 --> 00:22:50,120 AND AGAIN LET ME HAND OFF NOW TO 579 00:22:50,120 --> 00:22:53,680 DAN COMBS. 580 00:22:53,680 --> 00:23:09,920 THANK YOU. I'M DAN COMBS, 581 00:23:09,920 --> 00:23:11,960 FOR PEOPLE WITH DOWN SYNDROME, 582 00:23:11,960 --> 00:23:16,640 THAT WAS A BEAUTIFUL OVERVIEW OF 583 00:23:16,640 --> 00:23:17,760 CONSENT. 584 00:23:17,760 --> 00:23:20,920 CONSENT VERSUS ASSENT IS 585 00:23:20,920 --> 00:23:21,880 DIFFERENT. 586 00:23:21,880 --> 00:23:28,800 AND THE FIRST FEW I'LL COVER 587 00:23:28,800 --> 00:23:29,360 ESSENTIALLY GUIDANCE. 588 00:23:29,360 --> 00:23:30,360 INFORMED CONSENT REQUIRED FROM 589 00:23:30,360 --> 00:23:34,520 ALL ADULTS TO BE IN A STUDY, 590 00:23:34,520 --> 00:23:37,000 EQUIVALENT FOR CHILDREN OR 591 00:23:37,000 --> 00:23:39,760 ADULTS WITH LEGAL GUARDIAN, 592 00:23:39,760 --> 00:23:43,120 PARENTAL PERMISSION, USUALLY THE 593 00:23:43,120 --> 00:23:45,080 SAME FORM. 594 00:23:45,080 --> 00:23:47,400 HHS REQUIREMENTS FOR CONSENT ARE 595 00:23:47,400 --> 00:23:48,120 SPELLED OUT. 596 00:23:48,120 --> 00:23:49,800 ESSENTIALLY EXPLAIN WHAT THE 597 00:23:49,800 --> 00:23:51,240 STUDY IS, MAKE SURE PEOPLE 598 00:23:51,240 --> 00:23:54,440 UNDERSTAND WHAT THE STUDY WOULD 599 00:23:54,440 --> 00:23:55,280 INVOLVE, IT'S VOLUNTARY AND THEY 600 00:23:55,280 --> 00:23:57,360 CAN DECIDE IF THEY WANT TO 601 00:23:57,360 --> 00:23:58,280 PARTICIPATE OR NOT. 602 00:23:58,280 --> 00:24:04,320 ASSENT, ON THE OTHER HAND, IS 603 00:24:04,320 --> 00:24:07,000 REQUIRED FROM CHILDREN ACROSS 604 00:24:07,000 --> 00:24:12,960 THE BOARD OR ADULTS UNABLE TO 605 00:24:12,960 --> 00:24:13,800 PROVIDE IT. 606 00:24:13,800 --> 00:24:15,920 UNLIKE CONSENT WHICH HAS PAGES 607 00:24:15,920 --> 00:24:20,800 OF WHAT SHOULD BE INCLUDED, FOR 608 00:24:20,800 --> 00:24:22,360 ASSENT IT'S DEFINED AS 609 00:24:22,360 --> 00:24:23,440 INDIVIDUAL'S AFFIRMATIVE 610 00:24:23,440 --> 00:24:25,000 AGREEMENT TO PARTICIPATE IN 611 00:24:25,000 --> 00:24:26,520 RESEARCH, MERE FAILURE TO OBJECT 612 00:24:26,520 --> 00:24:28,920 SHOULD NOT, AN SENT AFFIRMATIVE 613 00:24:28,920 --> 00:24:30,840 AGREEMENT, BE CONSTRUED AT 614 00:24:30,840 --> 00:24:32,640 ASSENT, AND THAT'S IT. 615 00:24:32,640 --> 00:24:34,720 THERE'S GUIDANCE BUT NOT MUCH 616 00:24:34,720 --> 00:24:35,240 PAST THAT. 617 00:24:35,240 --> 00:24:38,520 WHICH MEANS IT'S ON THE 618 00:24:38,520 --> 00:24:43,920 INVESTIGATOR OR INSTITUTIONAL 619 00:24:43,920 --> 00:24:45,760 REVIEW BOARD TO PROVIDE WHAT TO 620 00:24:45,760 --> 00:24:47,000 BE COVERED, AN OPEN AREA WHICH 621 00:24:47,000 --> 00:24:50,280 IS GOOD AND BAD. 622 00:24:50,280 --> 00:24:57,920 IT'S BAD IN THAT IT'S NOT 623 00:24:57,920 --> 00:24:58,400 (INDISCERNIBLE). 624 00:24:58,400 --> 00:25:01,320 WHEN IS ASSENT NOT REQUIRED? 625 00:25:01,320 --> 00:25:06,120 THERE'S THREE CATEGORIES THAT 626 00:25:06,120 --> 00:25:07,320 HHS PROVIDES, SO IF CAPABILITY 627 00:25:07,320 --> 00:25:10,280 OF SOME OR ALL OF THE 628 00:25:10,280 --> 00:25:12,920 INDIVIDUALS IS LIMITED THAT THEY 629 00:25:12,920 --> 00:25:15,760 CANNOT BE CONSULTED, IN GENERAL 630 00:25:15,760 --> 00:25:21,480 FOR KIDS UNDER 7, FOR PEOPLE 631 00:25:21,480 --> 00:25:23,760 WITH INTELLECTUAL DISABILITY 632 00:25:23,760 --> 00:25:25,600 THIS IS DEPENDENT. 633 00:25:25,600 --> 00:25:26,920 SOME WILL WAIVE IT ACROSS THE 634 00:25:26,920 --> 00:25:27,360 BOARD. 635 00:25:27,360 --> 00:25:30,120 THERE'S A LOT OF HETEROGENEITY 636 00:25:30,120 --> 00:25:31,840 IN THIS. 637 00:25:31,840 --> 00:25:34,240 THE OTHER REASONS, LESS 638 00:25:34,240 --> 00:25:35,040 RELEVANT, IF IT'S AN 639 00:25:35,040 --> 00:25:36,760 INTERVENTION THAT'S GOING TO 640 00:25:36,760 --> 00:25:38,080 DIRECTLY BENEFIT THEM, MEDICAL 641 00:25:38,080 --> 00:25:40,280 CARE NOT OTHERWISE AVAILABLE, 642 00:25:40,280 --> 00:25:42,360 YOU CAN WAIVE ASSENT, PASSIONATE 643 00:25:42,360 --> 00:25:45,200 FOR MEDICAL CARE, WAIVE ASSENT. 644 00:25:45,200 --> 00:25:53,400 AND THEN IF IT'S A WAIVER FOR 645 00:25:53,400 --> 00:25:58,200 THE SAME IN ADULTS -- 646 00:25:58,200 --> 00:25:58,640 [AUDIO DISTORTION] 647 00:25:58,640 --> 00:26:01,480 FOR COVERING THE SAME 648 00:26:01,480 --> 00:26:03,360 INFORMATION CONSENT WOULD COVER, 649 00:26:03,360 --> 00:26:06,960 AND OTHERWISE YOUNGER KIDS OR 650 00:26:06,960 --> 00:26:08,680 INDIVIDUALS WITH INTELLECTUAL 651 00:26:08,680 --> 00:26:09,920 DISABILITIES, IT'S REALLY 652 00:26:09,920 --> 00:26:12,200 VARIABLE, BUT THE LAST PUT 653 00:26:12,200 --> 00:26:13,680 POINT, I LIKE THIS EXPLANATION, 654 00:26:13,680 --> 00:26:15,200 WHAT THE EXPERIENCE WILL BE, HOW 655 00:26:15,200 --> 00:26:17,360 LONG WILL IT TAKE, WHETHER IT 656 00:26:17,360 --> 00:26:25,200 WILL INVOLVE PAIN OR DISCOMFORT. 657 00:26:25,200 --> 00:26:27,400 CAPACITY IS ESSENTIALLY DO YOU 658 00:26:27,400 --> 00:26:29,720 UNDERSTAND WHAT'S BEING ASKED, 659 00:26:29,720 --> 00:26:31,440 CAN YOU MAKE DECISIONS. 660 00:26:31,440 --> 00:26:34,280 CAPACITY FOR RESEARCH HAS A 661 00:26:34,280 --> 00:26:35,840 FRAMEWORK, FOUR DOMAINS. 662 00:26:35,840 --> 00:26:36,760 FIRST IS UNDERSTANDING. 663 00:26:36,760 --> 00:26:38,040 WHICH IS WHAT'S GOING TO HAPPEN 664 00:26:38,040 --> 00:26:39,960 IF I'M IN THE STUDY. 665 00:26:39,960 --> 00:26:41,400 THINGS LIKE I'LL TAKE 666 00:26:41,400 --> 00:26:43,960 MEDICATION, I'LL HAVE BLOOD 667 00:26:43,960 --> 00:26:44,440 DRAWN. 668 00:26:44,440 --> 00:26:46,000 APPRECIATION, THIS IS THE NEXT 669 00:26:46,000 --> 00:26:47,880 STEP UP, NOT ONLY DO I KNOW WHAT 670 00:26:47,880 --> 00:26:50,280 WILL HAPPEN BUT HOW DOES THIS 671 00:26:50,280 --> 00:26:50,800 AFFECT ME? 672 00:26:50,800 --> 00:26:52,680 EXAMPLE WOULD BE IF I'M IN THE 673 00:26:52,680 --> 00:26:54,640 STUDY AND THERE'S A BLOOD DRAW 674 00:26:54,640 --> 00:26:56,960 IT MIGHT HURT MY ARM, AND I 675 00:26:56,960 --> 00:26:59,240 WON'T BE ABLE TO GO BOWLING, 676 00:26:59,240 --> 00:27:03,800 WHICH I REALLY LIKE TO DO. 677 00:27:03,800 --> 00:27:04,920 REASONING IS DECIDING DO YOU 678 00:27:04,920 --> 00:27:08,320 WANT TO PARTICIPATE OR NOT, SO 679 00:27:08,320 --> 00:27:08,880 CONSIDERING ADVANTAGES, 680 00:27:08,880 --> 00:27:09,960 DISADVANTAGES, THAT MIGHT BE I 681 00:27:09,960 --> 00:27:12,520 DON'T WANT TO BE IN THE STUDY 682 00:27:12,520 --> 00:27:15,880 BECAUSE THE BLOOD DRAW MIGHT 683 00:27:15,880 --> 00:27:18,720 HURT, OR IT MIGHT HURT BUT MIGHT 684 00:27:18,720 --> 00:27:21,160 HELP SO I WANT TO BE IN THE 685 00:27:21,160 --> 00:27:21,520 STUDY. 686 00:27:21,520 --> 00:27:22,600 FINALLY MAKING DECISIONS. 687 00:27:22,600 --> 00:27:24,760 Y, 688 00:27:24,760 --> 00:27:30,960 YES, I WANT TO BE IN IT, NO, I 689 00:27:30,960 --> 00:27:31,280 DON'T. 690 00:27:31,280 --> 00:27:32,960 ASKING BEFORE YOU SAID YOU 691 00:27:32,960 --> 00:27:34,360 WANTED TO DO THE STUDY, IS THAT 692 00:27:34,360 --> 00:27:35,560 STILL THE CASE? 693 00:27:35,560 --> 00:27:41,280 HELPFUL TO MAKE SURE THIS IS A 694 00:27:41,280 --> 00:27:42,000 CONSISTENT DECISION. 695 00:27:42,000 --> 00:27:45,080 THIS IS RELEVANT FOR PEOPLE WITH 696 00:27:45,080 --> 00:27:50,200 DOWN SYNDROME, DO PARTICIPANTS 697 00:27:50,200 --> 00:27:50,760 HAVE CAPACITY? 698 00:27:50,760 --> 00:27:52,640 CHILDREN UNDER 7 IS MORE OR LESS 699 00:27:52,640 --> 00:27:56,240 ACCEPTED THAT DON'T HAVE 700 00:27:56,240 --> 00:27:56,560 CAPACITY. 701 00:27:56,560 --> 00:27:59,680 SIMILARLY IN POPULATION OF 702 00:27:59,680 --> 00:28:00,160 COMPLETELY NON-VERBAL 703 00:28:00,160 --> 00:28:01,560 INDIVIDUALS, IT WOULD BE 704 00:28:01,560 --> 00:28:04,200 REASONABLE THEY PROBABLY DON'T 705 00:28:04,200 --> 00:28:05,840 HAVE CAPACITY BECAUSE THEY CAN'T 706 00:28:05,840 --> 00:28:07,440 PROVIDE THE DECISION, THINGS 707 00:28:07,440 --> 00:28:10,640 LIKE THAT, IRBs MAY GRANT AN 708 00:28:10,640 --> 00:28:15,800 EXEMPTION FOR THAT REASON. 709 00:28:15,800 --> 00:28:19,080 IN STUDIES BETWEEN 9 AND 12, 710 00:28:19,080 --> 00:28:21,640 UNDER 7 PRETTY MUCH NO CHILDREN 711 00:28:21,640 --> 00:28:24,880 HAVE CAPACITY, OVER 12 MOST IF 712 00:28:24,880 --> 00:28:26,160 NOT ALL TYPICALLY DEVELOPING 713 00:28:26,160 --> 00:28:27,360 CHILDREN HAVE CAPACITY. 714 00:28:27,360 --> 00:28:32,640 AT A STUDY LEVEL THE IRB WILL 715 00:28:32,640 --> 00:28:34,000 DECIDE ASSENT, GET CONSENT FOR 716 00:28:34,000 --> 00:28:35,720 THIS GROUP, OR ASSENT FOR 717 00:28:35,720 --> 00:28:39,440 EVERYONE. 718 00:28:39,440 --> 00:28:42,080 AT THE INDIVIDUAL LEVEL, IT'S UP 719 00:28:42,080 --> 00:28:45,680 TO THE INVESTIGATOR OR STUDY 720 00:28:45,680 --> 00:28:46,320 STAFF. 721 00:28:46,320 --> 00:28:51,880 THERE ARE CAPACITY EVALUATION 722 00:28:51,880 --> 00:28:55,760 INSTRUMENTS, THOSE TEND TO DO 723 00:28:55,760 --> 00:28:57,400 THINGS LIKE TELL ME WHAT'S GOING 724 00:28:57,400 --> 00:29:05,080 TO HAPPEN IN THE STUDY, THINGS 725 00:29:05,080 --> 00:29:08,160 YOU CAN DO INSTEAD OF USING 726 00:29:08,160 --> 00:29:09,240 INSTRUMENT, ARE PARTICIPANTS 727 00:29:09,240 --> 00:29:10,640 PAYING ATTENTION, WATCHING YOU, 728 00:29:10,640 --> 00:29:14,240 SEEM LIKE THEY ARE ENGAGED, 729 00:29:14,240 --> 00:29:15,480 TEACH BACK, TELL ME WHAT WE'RE 730 00:29:15,480 --> 00:29:18,400 GOING TO DO IN THE STUDY, THOSE 731 00:29:18,400 --> 00:29:19,480 ARE SIMPLE EASY APPROACHES TO 732 00:29:19,480 --> 00:29:22,920 GET A SENSE OF CAPACITY FOR ANY 733 00:29:22,920 --> 00:29:27,880 INDIVIDUAL PARTICIPANT. 734 00:29:27,880 --> 00:29:29,560 >> DAN, APOLOGIES FOR 735 00:29:29,560 --> 00:29:30,080 INTERRUPTING. 736 00:29:30,080 --> 00:29:31,680 WOULD IT BE POSSIBLE TO SLOW THE 737 00:29:31,680 --> 00:29:34,400 PACE DOWN FOR OUR SPANISH 738 00:29:34,400 --> 00:29:34,760 INTERPRETERS? 739 00:29:34,760 --> 00:29:35,000 >> YES. 740 00:29:35,000 --> 00:29:35,960 >> THANK YOU. 741 00:29:35,960 --> 00:29:40,520 WE APPRECIATE IT. 742 00:29:40,520 --> 00:29:41,080 >> SORRY. 743 00:29:41,080 --> 00:29:41,960 OKAY. 744 00:29:41,960 --> 00:29:46,240 LOOKING-- THE CHALLENGE OF 745 00:29:46,240 --> 00:29:49,560 ASSENT, I THINK THIS IS AN OPEN 746 00:29:49,560 --> 00:29:52,720 QUESTIONING, HARD TO ANSWER. 747 00:29:52,720 --> 00:29:55,120 WITH ASSENT, WHEN SHOULD IT BE 748 00:29:55,120 --> 00:29:56,320 WAIVED? 749 00:29:56,320 --> 00:29:58,320 WAIVING FOR INFANTS OBVIOUSLY 750 00:29:58,320 --> 00:29:58,920 MAKE SENSE. 751 00:29:58,920 --> 00:30:02,360 BUT THEN AT WHAT POINT, SO 752 00:30:02,360 --> 00:30:03,200 INDIVIDUALS WITH INTELLECTUAL 753 00:30:03,200 --> 00:30:05,280 DISABILITIES, WHEN SHOULD YOU 754 00:30:05,280 --> 00:30:07,040 WAIVE ASSENT, IF YOU REQUIRE 755 00:30:07,040 --> 00:30:08,800 ASSENT FOR EVERYONE, LOWER 756 00:30:08,800 --> 00:30:10,880 FUNCTIONING INDIVIDUALS CAN 757 00:30:10,880 --> 00:30:13,600 POTENTIALLY BE EXCLUDED, SO 758 00:30:13,600 --> 00:30:14,840 NON-VERBAL INDIVIDUALS WHO CAN'T 759 00:30:14,840 --> 00:30:18,280 PROVIDE ASSENT WOULD BE EXCLUDED 760 00:30:18,280 --> 00:30:19,800 SO CAN'T BENEFIT. 761 00:30:19,800 --> 00:30:21,720 ON THE CONVERSE IF YOU WAIVE 762 00:30:21,720 --> 00:30:22,480 ASSENT YOU'RE POTENTIALLY 763 00:30:22,480 --> 00:30:24,440 RISKING A LEVEL OF PROTECTION 764 00:30:24,440 --> 00:30:26,800 FOR PARTICIPANTS AS WELL AS 765 00:30:26,800 --> 00:30:28,920 POTENTIALLY NOT GIVING THEM 766 00:30:28,920 --> 00:30:29,520 RESPECT. 767 00:30:29,520 --> 00:30:32,520 THERE'S THIS BALANCE OF TOO HIGH 768 00:30:32,520 --> 00:30:37,360 A BAR, EXCLUDES PEOPLE. 769 00:30:37,360 --> 00:30:42,400 TOO LOW DOESN'T RESPECT STUDY 770 00:30:42,400 --> 00:30:43,400 PARTICIPANTS. 771 00:30:43,400 --> 00:30:46,600 WITH THAT A FEW DIFFERENT IDEAS 772 00:30:46,600 --> 00:30:50,280 OF GOAL OF ASSENT. 773 00:30:50,280 --> 00:30:50,840 TRADITIONAL FRAMEWORK, IT'S 774 00:30:50,840 --> 00:30:51,240 DECISION MAKING. 775 00:30:51,240 --> 00:30:53,120 DO YOU WANT TO BE IN THE STUDY, 776 00:30:53,120 --> 00:30:54,320 YES OR NO. 777 00:30:54,320 --> 00:30:56,360 SOME PEOPLE ARGUE MAYBE IT 778 00:30:56,360 --> 00:30:59,040 SHOULDN'T BE DECISION MAKING BUT 779 00:30:59,040 --> 00:31:00,680 RESPECT FOR THAT PARTICIPANT, 780 00:31:00,680 --> 00:31:04,160 EXPLAINING THE STUDY, DISCUSSING 781 00:31:04,160 --> 00:31:05,280 THE STUDY. 782 00:31:05,280 --> 00:31:07,320 THE OTHER IDEA, IS ASSENT 783 00:31:07,320 --> 00:31:09,120 PROVIDING PROTECTION? 784 00:31:09,120 --> 00:31:10,960 SO LIKE INFORMED CONSENT TO 785 00:31:10,960 --> 00:31:12,600 PROTECT THE PARTICIPANT, IS 786 00:31:12,600 --> 00:31:13,560 ASSENT HELPING THAT PARTICIPANT 787 00:31:13,560 --> 00:31:17,840 TO MAKE SURE THEY WANT TO BE IN 788 00:31:17,840 --> 00:31:20,000 THE STUDY, WEIGHING THEIR 789 00:31:20,000 --> 00:31:21,640 PERSONAL RISK/BENEFITS. 790 00:31:21,640 --> 00:31:23,240 WITH THAT GOAL, DIFFERENT 791 00:31:23,240 --> 00:31:26,760 INFORMATION IS GOING TO NEED TO 792 00:31:26,760 --> 00:31:31,720 BE INCLUDED IN ASSENT. 793 00:31:31,720 --> 00:31:32,920 SO IT'S DECISION MAKING, GIVE A 794 00:31:32,920 --> 00:31:36,480 LOT OF INFORMATION, MAKE SURE 795 00:31:36,480 --> 00:31:37,800 IT'S UNDERSTOOD. 796 00:31:37,800 --> 00:31:39,320 FOR RESPECT, MORE SIMPLE AS 797 00:31:39,320 --> 00:31:40,080 EXPLAINING THE STUDY, MAKING 798 00:31:40,080 --> 00:31:45,960 SURE YOU CAN BE IN THE STUDY OR 799 00:31:45,960 --> 00:31:46,840 NOT, CAN WITHDRAW ANYTIME. 800 00:31:46,840 --> 00:31:49,960 WITH THAT THERE'S A RANGE OF HOW 801 00:31:49,960 --> 00:31:51,200 MUCH INFORMATION, SO FOR 802 00:31:51,200 --> 00:31:53,440 CLINICAL TRIAL THINGS LIKE 803 00:31:53,440 --> 00:31:54,600 RANDOMIZATION, PLACEBO, ARE 804 00:31:54,600 --> 00:31:55,440 DIFFICULT CONCEPTS. 805 00:31:55,440 --> 00:31:59,920 YOU'LL HAVE A SLEEP STUDY, BLOOD 806 00:31:59,920 --> 00:32:01,880 TAKEN, TAKE MEDICATION, THOSE 807 00:32:01,880 --> 00:32:02,760 ARE MORE STRAIGHTFORWARD. 808 00:32:02,760 --> 00:32:05,080 YOU NEED TO BALANCE GIVING 809 00:32:05,080 --> 00:32:05,960 ENOUGH INFORMATION WITHOUT 810 00:32:05,960 --> 00:32:12,680 OVERWHELMING PEOPLE AND MAKING 811 00:32:12,680 --> 00:32:14,320 SURE IT'S UNDERSTANDABLE. 812 00:32:14,320 --> 00:32:17,080 SO THERE'S GENERALLY FOUR 813 00:32:17,080 --> 00:32:19,480 APPROACHES PEOPLE HAVE PROPOSED. 814 00:32:19,480 --> 00:32:25,400 THE FIRST IS ESSENTIALLY ASSENT 815 00:32:25,400 --> 00:32:27,680 IS MINI CONSENT, IF YOU LOOK AT 816 00:32:27,680 --> 00:32:29,800 THIS DOMAIN, CAPACITY I 817 00:32:29,800 --> 00:32:30,440 MENTIONED PREVIOUSLY, THIS 818 00:32:30,440 --> 00:32:32,480 REQUIRES ALL OF THEM, TO 819 00:32:32,480 --> 00:32:33,240 UNDERSTAND THE INFORMATION, YOU 820 00:32:33,240 --> 00:32:36,080 NEED TO APPRECIATE HOW IT'S 821 00:32:36,080 --> 00:32:38,080 GOING TO AFFECT YOU, USE THAT TO 822 00:32:38,080 --> 00:32:39,600 REASON WHAT WAY YOU WANT TO GO, 823 00:32:39,600 --> 00:32:42,320 AND THEN MAKE A DECISION. 824 00:32:42,320 --> 00:32:43,680 THIS IS THE DEFAULT MOST PEOPLE 825 00:32:43,680 --> 00:32:44,640 GO TO. 826 00:32:44,640 --> 00:32:55,120 I DON'T KNOW THAT IT'S RIGHT 827 00:32:55,760 --> 00:32:55,960 APPROACH. 828 00:32:55,960 --> 00:33:00,920 THIS IS PROPOSED BY A PANEL OF 829 00:33:00,920 --> 00:33:02,360 BIOETHICISTS AND RESEARCHERS, 830 00:33:02,360 --> 00:33:03,680 ASSENT INVOLVES UNDERSTANDING 831 00:33:03,680 --> 00:33:04,440 BASIC STUDY-SPECIFIC 832 00:33:04,440 --> 00:33:06,400 INFORMATION, AND BE ABLE TO 833 00:33:06,400 --> 00:33:07,680 APPRECIATE YOU WHO THE 834 00:33:07,680 --> 00:33:09,480 INFORMATION APPLIES TO YOUR OWN 835 00:33:09,480 --> 00:33:14,840 SITUATION, AND THIS IS MORE 836 00:33:14,840 --> 00:33:17,000 UNDERSTANDING AND APPRECIATION. 837 00:33:17,000 --> 00:33:19,640 SO THIS, AGAIN, I'LL GIVE BLOOD 838 00:33:19,640 --> 00:33:22,360 DRAW, BLOOD DRAW MAY HURT. 839 00:33:22,360 --> 00:33:24,240 YOU NEED TO KNOW WHY YOU'RE 840 00:33:24,240 --> 00:33:25,320 GETTING THE BLOOD DRAW, 841 00:33:25,320 --> 00:33:30,160 UNDERSTANDING WHAT HAPPENS TO 842 00:33:30,160 --> 00:33:30,800 YOU DIRECTLY, ANOTHER PROPOSAL 843 00:33:30,800 --> 00:33:32,800 WOULD BE INDICATE A PREFERENCE 844 00:33:32,800 --> 00:33:35,320 BETWEEN OPTIONS AND BE ABLE TO 845 00:33:35,320 --> 00:33:36,280 COMMUNICATE THESE OPTIONS. 846 00:33:36,280 --> 00:33:38,480 SO THIS DOES REQUIRE MAKING A 847 00:33:38,480 --> 00:33:41,440 DECISION, AS WELL AS FAIRLY HIGH 848 00:33:41,440 --> 00:33:43,240 LEVEL OF UNDERSTANDING, SO WHAT 849 00:33:43,240 --> 00:33:44,760 ARE THE TWO OPTIONS? 850 00:33:44,760 --> 00:33:47,440 WHAT HAPPENS IF I'M IN THE 851 00:33:47,440 --> 00:33:47,800 STUDY? 852 00:33:47,800 --> 00:33:49,200 I'LL TAKE MEDICATION, GET A 853 00:33:49,200 --> 00:33:52,120 BLOOD DRAW, THINGS LIKE THAT. 854 00:33:52,120 --> 00:33:58,840 AND THEN THE LAST OPTION, AGAIN, 855 00:33:58,840 --> 00:34:01,240 ASSENT IS NOT ABOUT DECISION 856 00:34:01,240 --> 00:34:03,080 MAKING, BUT IT'S ABOUT ENGAGING 857 00:34:03,080 --> 00:34:04,280 WITH INDIVIDUALS PRIOR TO 858 00:34:04,280 --> 00:34:04,920 RESEARCH PARTICIPATION. 859 00:34:04,920 --> 00:34:06,680 THE FOCUS HERE IS ON SPEAKING 860 00:34:06,680 --> 00:34:08,000 WITH THE INDIVIDUAL, EXPLAINING 861 00:34:08,000 --> 00:34:12,960 THE STUDY AT THEIR LEVEL OF 862 00:34:12,960 --> 00:34:13,560 UNDERSTANDING, NOT NECESSARILY 863 00:34:13,560 --> 00:34:15,880 DECIDING TO BE IN THE STUDY OR 864 00:34:15,880 --> 00:34:16,080 NOT. 865 00:34:16,080 --> 00:34:17,320 THIS REQUIRES UNDERSTANDING, THE 866 00:34:17,320 --> 00:34:19,480 PARALLEL IN CLINICAL PRACTICE IS 867 00:34:19,480 --> 00:34:21,800 THAT IN CLINICAL CARE FOR 868 00:34:21,800 --> 00:34:23,000 PEDIATRICS, FOR EXAMPLE, IF THE 869 00:34:23,000 --> 00:34:24,680 5-YEAR-OLD IS GOING TO HAVE A 870 00:34:24,680 --> 00:34:25,880 SURGERY YOU'RE NOT TELLING THEM 871 00:34:25,880 --> 00:34:27,280 DO YOU WANT THE SURGERY OR NOT 872 00:34:27,280 --> 00:34:29,480 BUT SAYING YOU'RE GOING TO HAVE 873 00:34:29,480 --> 00:34:30,880 THE SURGERY, HERE IS THE SIDE 874 00:34:30,880 --> 00:34:32,320 EFFECTS, HERE IS WHAT MAY HAPPEN 875 00:34:32,320 --> 00:34:33,720 TO YOU. 876 00:34:33,720 --> 00:34:35,360 IT'S ENGAGING THEM, HELPING THEM 877 00:34:35,360 --> 00:34:36,800 UNDERSTAND WHAT'S GOING TO 878 00:34:36,800 --> 00:34:41,960 HAPPEN, AND GOING FROM THERE. 879 00:34:41,960 --> 00:34:45,440 SO OUR CURRENT APPROACH, 880 00:34:45,440 --> 00:34:51,040 BRIEFLY, SO WE KEEP IT SIMPLE, 881 00:34:51,040 --> 00:34:53,960 POWERPOINT SLIDES ALL RUNLY 882 00:34:53,960 --> 00:34:57,280 QUICKLY, WHAT WILL HAPPEN TO ME, 883 00:34:57,280 --> 00:34:59,560 PROBABLY THE SINGLE BIGGEST TWO, 884 00:34:59,560 --> 00:35:01,120 IS IT VOLUNTARY, YOU CAN 885 00:35:01,120 --> 00:35:03,600 WITHDRAW AT ANY TIME, VERY 886 00:35:03,600 --> 00:35:05,360 IMPORTANT PROTECTIONS 887 00:35:05,360 --> 00:35:07,560 PARTICIPANTS NEEDS TO KNOW, 888 00:35:07,560 --> 00:35:08,880 EMPHASIZING THAT. 889 00:35:08,880 --> 00:35:16,040 HERE IS -- I PULLED OUT HALF 890 00:35:16,040 --> 00:35:20,080 FROM THE CURRENT CLINICAL TRIAL, 891 00:35:20,080 --> 00:35:24,200 MEDICATIONS FOR SLEEP APNEA. 892 00:35:24,200 --> 00:35:25,760 WHAT DOES BEING IN THIS RESEARCH 893 00:35:25,760 --> 00:35:27,000 STUDY MEAN FOR YOU? 894 00:35:27,000 --> 00:35:29,560 THE GOAL IS TO HELP PEOPLE 895 00:35:29,560 --> 00:35:30,640 BREATHE BETTER WHILE THEY SLEEP. 896 00:35:30,640 --> 00:35:36,040 IF YOU SAY IT'S OKAY, 897 00:35:36,040 --> 00:35:37,880 EMPHASIZING IT'S NOT REQUIRED. 898 00:35:37,880 --> 00:35:39,960 MEDICATION FOR SIX MONTHS, WE'LL 899 00:35:39,960 --> 00:35:41,720 WATCH YOU SLEEP FOR TWO NIGHTS, 900 00:35:41,720 --> 00:35:43,680 THERE'S A COUPLE OTHER MEASURES 901 00:35:43,680 --> 00:35:45,400 WE'LL TOUCH ON, BUT, AGAIN, IF 902 00:35:45,400 --> 00:35:47,200 YOU DON'T FEEL COMFORTABLE AT 903 00:35:47,200 --> 00:35:48,720 ANY POINT IN ANYTHING, IT'S OKAY 904 00:35:48,720 --> 00:35:49,480 TO STOP. 905 00:35:49,480 --> 00:35:51,640 YOU CAN ALWAYS ASK TO STOP. 906 00:35:51,640 --> 00:35:52,960 THAT'S REALLY IMPORTANT. 907 00:35:52,960 --> 00:35:55,480 WE EMPHASIZE THAT OVER AND OVER 908 00:35:55,480 --> 00:35:58,480 IN THE PRESENTATION, IT'S 909 00:35:58,480 --> 00:35:58,720 VOLUNTARY. 910 00:35:58,720 --> 00:36:05,320 SO THIS IS WHAT THE SPEECH 911 00:36:05,320 --> 00:36:09,160 DEVICE LOOKS LIKE, A CHILD 912 00:36:09,160 --> 00:36:11,480 WEARING A VEST. 913 00:36:11,480 --> 00:36:13,760 YOU'LL PLAY GAMES, USING AN 914 00:36:13,760 --> 00:36:16,080 IPAD, WHAT THIS LOOKS LIKE. 915 00:36:16,080 --> 00:36:17,960 YOU'LL SPEND THE NIGHT IN A 916 00:36:17,960 --> 00:36:18,600 SLEEP LAB. 917 00:36:18,600 --> 00:36:21,080 WHEN THEY COME FOR THE FIRST 918 00:36:21,080 --> 00:36:24,440 TIME THEY HAVE SEEN THE ROOM 919 00:36:24,440 --> 00:36:24,720 ALREADY. 920 00:36:24,720 --> 00:36:26,400 THEY SIT IN A CHAIR. 921 00:36:26,400 --> 00:36:29,040 THEY WILL PUT STICKERS ON YOUR 922 00:36:29,040 --> 00:36:29,920 HEAD. 923 00:36:29,920 --> 00:36:32,080 THERE'S NO NEEDLES THAT WILL 924 00:36:32,080 --> 00:36:33,880 HURT, EMPHASIZING IT'S NOT 925 00:36:33,880 --> 00:36:34,080 PAINFUL. 926 00:36:34,080 --> 00:36:35,800 AND THEN ONCE YOU HAVE ALL THESE 927 00:36:35,800 --> 00:36:38,240 THINGS ON YOU'LL LOOK LIKE THIS 928 00:36:38,240 --> 00:36:39,760 AND YOU'LL SLEEP LIKE NORMAL. 929 00:36:39,760 --> 00:36:41,520 IN THE MORNING YOU GO HOME. 930 00:36:41,520 --> 00:36:44,360 AND THEN YOU'LL TAKE YOUR 931 00:36:44,360 --> 00:36:46,760 MEDICATION AT HOME EVERY DAY FOR 932 00:36:46,760 --> 00:36:48,760 SIX MONTHS. 933 00:36:48,760 --> 00:36:50,600 SO THAT'S OUR APPROACH, SIMPLE, 934 00:36:50,600 --> 00:36:51,600 HITTING HIGH POINTS. 935 00:36:51,600 --> 00:36:53,880 ONE OF THE IMPORTANT 936 00:36:53,880 --> 00:36:55,520 DISTINCTIONS IS THAT ASSENT 937 00:36:55,520 --> 00:36:57,480 TENDS TO GET TREATED AS AN 938 00:36:57,480 --> 00:36:58,640 EVENT, I'LL HAVE YOU SIGN THIS 939 00:36:58,640 --> 00:37:01,280 PAPER AND GO FROM THERE. 940 00:37:01,280 --> 00:37:02,240 ASSENT IS ABSOLUTELY ONGOING. 941 00:37:02,240 --> 00:37:05,960 THIS IS A KEY PROTECTION FOR 942 00:37:05,960 --> 00:37:11,520 INDIVIDUALS WITH DISABILITIES. 943 00:37:11,520 --> 00:37:13,200 CONTINUING TO BE MONITORED 944 00:37:13,200 --> 00:37:15,360 THROUGHOUT, AND CAN SAY NO, JUST 945 00:37:15,360 --> 00:37:17,000 BECAUSE ASSENT HAS BEEN GIVEN 946 00:37:17,000 --> 00:37:19,640 THEY CAN WITHDRAW AT ANY POINT. 947 00:37:19,640 --> 00:37:20,520 IT'S IMPORTANT THIS DOESN'T NEED 948 00:37:20,520 --> 00:37:21,840 TO BE SOMEONE SAYS NO, I DON'T 949 00:37:21,840 --> 00:37:26,600 WANT TO BE IN THE STUDY, EVEN 950 00:37:26,600 --> 00:37:27,520 NON-VERBAL PARTICIPANTS CAN 951 00:37:27,520 --> 00:37:30,920 EXPRESS THEY DON'T APPROVE OF 952 00:37:30,920 --> 00:37:31,600 SOMETHING. 953 00:37:31,600 --> 00:37:32,560 CRYING, NOT COOPERATING WITH 954 00:37:32,560 --> 00:37:33,840 STUDY PROCEDURES. 955 00:37:33,840 --> 00:37:36,440 THESE ARE ALL SIGNS ASSENT IS 956 00:37:36,440 --> 00:37:37,280 PROBABLY NO LONGER THERE. 957 00:37:37,280 --> 00:37:42,760 THIS IS A TIME TO SIT DOWN WITH 958 00:37:42,760 --> 00:37:44,160 PARENTS, SOMETIMES CRYING FOR 959 00:37:44,160 --> 00:37:45,840 BLOOD PRESSURE WILL PASS, THAT'S 960 00:37:45,840 --> 00:37:46,040 OKAY. 961 00:37:46,040 --> 00:37:47,240 BUT RECOGNIZING THAT, IF YOU 962 00:37:47,240 --> 00:37:48,280 KNOW SOMEONE IS UNCOMFORTABLE 963 00:37:48,280 --> 00:37:51,120 FOR MORE THAN A FEW MINUTES IT'S 964 00:37:51,120 --> 00:37:52,840 BEST THAT WE CHANGE OR IT SHOULD 965 00:37:52,840 --> 00:37:55,880 BE STOPPED AND HAVE THE 966 00:37:55,880 --> 00:37:57,200 PARTICIPANT LEAVE THE STUDY. 967 00:37:57,200 --> 00:37:58,160 THAT'S THE REAL IMPORTANT 968 00:37:58,160 --> 00:38:04,120 PROTECTION THAT HAS TO BE 969 00:38:04,120 --> 00:38:04,400 RESPECTED. 970 00:38:04,400 --> 00:38:05,640 BRIEFLY WE'RE GOING TO BE 971 00:38:05,640 --> 00:38:07,400 STARTING A STUDY LOOKING AT 972 00:38:07,400 --> 00:38:10,800 ASSENT IN PEOPLE WITH DOWN 973 00:38:10,800 --> 00:38:11,560 SYNDROME. 974 00:38:11,560 --> 00:38:14,960 I MENTIONED FOUR APPROACHES TO 975 00:38:14,960 --> 00:38:15,320 ASSENT. 976 00:38:15,320 --> 00:38:17,920 NO DATA IN PEOPLE WITH DOWN 977 00:38:17,920 --> 00:38:18,200 SYNDROME. 978 00:38:18,200 --> 00:38:20,120 WE'RE GOING TO DO A STUDY WITH 979 00:38:20,120 --> 00:38:21,400 TWO MAJOR AIMS. 980 00:38:21,400 --> 00:38:23,480 FIRST, WHAT ARE FAMILY 981 00:38:23,480 --> 00:38:23,960 PREFERENCES. 982 00:38:23,960 --> 00:38:25,680 HOW DO FAMILIES THINK ASSENT 983 00:38:25,680 --> 00:38:26,880 SHOULD BE HANDLED. 984 00:38:26,880 --> 00:38:28,600 WHAT THEIR BELIEFS AND 985 00:38:28,600 --> 00:38:30,320 PREFERENCE IS. 986 00:38:30,320 --> 00:38:32,440 ACTUALLY GOING TO ASSESS 987 00:38:32,440 --> 00:38:34,560 CAPACITY FOR PARTICIPATION IN 988 00:38:34,560 --> 00:38:37,920 PEOPLE WITH DOWN SYNDROME, 989 00:38:37,920 --> 00:38:40,120 THERE'S AN EXISTING TOOL FOR 990 00:38:40,120 --> 00:38:43,480 THAT ARE, THE AUTHOR WAS HELPING 991 00:38:43,480 --> 00:38:46,920 WITH THE STUDY, GOING TO MEASURE 992 00:38:46,920 --> 00:38:48,680 WHAT DOMAINS PEOPLE TEND TO DO 993 00:38:48,680 --> 00:38:50,200 THE BEST FOR CAPACITY AND USE 994 00:38:50,200 --> 00:38:55,960 THAT TO GUIDE HOW CAN WE TAILOR 995 00:38:55,960 --> 00:38:56,880 ASSENT TO SOMETHING THE MOST 996 00:38:56,880 --> 00:39:00,960 UNDERSTANDABLE FOR THE MOST 997 00:39:00,960 --> 00:39:01,560 PARTICIPANTS WITH DOWN SYNDROME, 998 00:39:01,560 --> 00:39:04,880 THE GOAL IS TO MAKE THE PROCESS 999 00:39:04,880 --> 00:39:05,440 MORE MEANINGFUL AND BETTER 1000 00:39:05,440 --> 00:39:07,520 ACROSS THE BOARD FOR STUDIES 1001 00:39:07,520 --> 00:39:11,000 WITH PEOPLE WITH DOWN SYNDROME. 1002 00:39:11,000 --> 00:39:12,120 THAT IS THAT. 1003 00:39:12,120 --> 00:39:13,120 THANK YOU. 1004 00:39:13,120 --> 00:39:15,680 MY E-MAIL IS HERE. 1005 00:39:15,680 --> 00:39:18,120 ANY COMMENTS, PLEASE LEAVE IN 1006 00:39:18,120 --> 00:39:19,520 THE CHAT. 1007 00:39:19,520 --> 00:39:20,440 ANYTHING ELSE, E-MAIL ME. 1008 00:39:20,440 --> 00:39:22,360 I WOULD LOVE TO HEAR YOUR 1009 00:39:22,360 --> 00:39:22,800 FEEDBACK. 1010 00:39:22,800 --> 00:39:24,480 AND THEN THANK YOU VERY MUCH. 1011 00:39:24,480 --> 00:39:25,920 >> THANK YOU, DAN. 1012 00:39:25,920 --> 00:39:31,560 WE MOVE TO OUR NEXT PRESENTER 1013 00:39:31,560 --> 00:39:34,120 REMINDER SINCE WE HAVE SPANISH 1014 00:39:34,120 --> 00:39:35,520 INTERPRETATION PLEASE TRY TO GO 1015 00:39:35,520 --> 00:39:37,600 SLOWLY THROUGH THE SLIDES AS WE 1016 00:39:37,600 --> 00:39:39,320 SPEAK SO THAT THE INTERPRETERS 1017 00:39:39,320 --> 00:39:41,520 CAN KEEP UP. 1018 00:39:41,520 --> 00:39:42,440 ALL RIGHT. 1019 00:39:42,440 --> 00:39:43,760 ANN, TAKE IT AWAY. 1020 00:39:43,760 --> 00:39:45,240 >> THANKS VERY MUCH. 1021 00:39:45,240 --> 00:39:46,680 THANK YOU SO MUCH TO THE 1022 00:39:46,680 --> 00:39:50,320 PREVIOUS SPEAKERS WHO DID SUCH A 1023 00:39:50,320 --> 00:39:52,840 FANTASTIC JOB OUTLINING ISSUES 1024 00:39:52,840 --> 00:39:55,760 OF CONSENT AND ASSENT IN DOWN 1025 00:39:55,760 --> 00:39:56,440 SYNDROME. 1026 00:39:56,440 --> 00:39:57,320 AND IN INTELLECTUAL 1027 00:39:57,320 --> 00:39:58,000 DISABILITIES. 1028 00:39:58,000 --> 00:40:01,160 I'M GOING TO DISCUSS A LITTLE 1029 00:40:01,160 --> 00:40:03,680 BIT RECRUITMENT OF HISTORICALLY 1030 00:40:03,680 --> 00:40:05,640 EXCLUDED AND MINORITIZED 1031 00:40:05,640 --> 00:40:09,600 POPULATIONS AND HOW THAT APPLIES 1032 00:40:09,600 --> 00:40:11,880 TO DOWN SYNDROME RESEARCH, AND 1033 00:40:11,880 --> 00:40:16,640 THE ROLE OF INFORMED CONSENT IN 1034 00:40:16,640 --> 00:40:18,040 RECRUITMENT OF THESE 1035 00:40:18,040 --> 00:40:18,440 POPULATIONS. 1036 00:40:18,440 --> 00:40:22,600 SO, WHAT I'M GOING TO TALK ABOUT 1037 00:40:22,600 --> 00:40:26,320 FIRST IS IN PITTSBURGH, OUR 1038 00:40:26,320 --> 00:40:27,760 EXPERIENCE WITH RECRUITING 1039 00:40:27,760 --> 00:40:29,160 UNDERREPRESENTED GROUPS IN STUDY 1040 00:40:29,160 --> 00:40:30,520 FOR AGING. 1041 00:40:30,520 --> 00:40:33,560 THIS IS REALLY WHERE FROM MY 1042 00:40:33,560 --> 00:40:36,520 RESEARCH PERSPECTIVE, WHERE WE 1043 00:40:36,520 --> 00:40:38,240 STARTED WITH TRYING TO 1044 00:40:38,240 --> 00:40:41,160 UNDERSTAND BETTER RECRUITMENT 1045 00:40:41,160 --> 00:40:41,920 STRATEGIES FOR BETTER 1046 00:40:41,920 --> 00:40:44,600 REPRESENTATION, IN RESEARCH 1047 00:40:44,600 --> 00:40:44,840 COHORTS. 1048 00:40:44,840 --> 00:40:48,440 AND SO I HAVE A LARGE 1049 00:40:48,440 --> 00:40:51,040 NEUROIMAGING STUDY OF BRAIN 1050 00:40:51,040 --> 00:40:54,120 AGING AND COGNITION, THAT 1051 00:40:54,120 --> 00:40:55,120 RECRUITED 400 PARTICIPANTS 1052 00:40:55,120 --> 00:40:59,160 ACROSS THE SPECTRUM OF AGING 1053 00:40:59,160 --> 00:41:00,680 FROM COGNITIVELY UNIMPAIRED TO 1054 00:41:00,680 --> 00:41:04,520 ALZHEIMER'S DISEASE, AND OUR 1055 00:41:04,520 --> 00:41:06,360 GOALS WERE TO HAVE 50% 1056 00:41:06,360 --> 00:41:09,360 REPRESENTATION OF MALES AND 1057 00:41:09,360 --> 00:41:12,520 FEMALES, AND 50% OF THE COHORT 1058 00:41:12,520 --> 00:41:13,520 BEING AFRICAN AMERICAN. 1059 00:41:13,520 --> 00:41:17,800 AND OTHER OUR GOAL WITHIN THIS 1060 00:41:17,800 --> 00:41:19,560 WAS TO IDENTIFY PARTICIPANTS WHO 1061 00:41:19,560 --> 00:41:20,560 WERE HAVING THEIR FIRST 1062 00:41:20,560 --> 00:41:21,840 EXPERIENCE WITH RESEARCH. 1063 00:41:21,840 --> 00:41:23,480 THAT WAS REALLY ONE OF OUR 1064 00:41:23,480 --> 00:41:26,320 GOALS, WAS TO NOT JUST REACH 1065 00:41:26,320 --> 00:41:28,520 UNDERREPRESENTED GROUPS BUT TO 1066 00:41:28,520 --> 00:41:30,160 REACH GROUPS WHO HISTORICALLY 1067 00:41:30,160 --> 00:41:32,880 WEREN'T PARTICIPATING IN 1068 00:41:32,880 --> 00:41:33,880 RESEARCH STUDIES. 1069 00:41:33,880 --> 00:41:36,000 AND SO OUR RECRUITMENT SOURCES 1070 00:41:36,000 --> 00:41:37,360 WERE FROM OUR ALZHEIMER'S 1071 00:41:37,360 --> 00:41:38,880 DISEASE RESEARCH CENTER, WHICH 1072 00:41:38,880 --> 00:41:41,000 WAS A VERY TRADITIONAL SORT OF 1073 00:41:41,000 --> 00:41:43,320 RESEARCH REGISTRY WITH VERY 1074 00:41:43,320 --> 00:41:44,600 TRADITIONAL PARTICIPANTS, THAT 1075 00:41:44,600 --> 00:41:47,280 YOU SEE IN CLINICAL TRIALS, AND 1076 00:41:47,280 --> 00:41:50,280 RESEARCH STUDIES, AND WE ALSO 1077 00:41:50,280 --> 00:41:51,400 UTILIZED COMMUNITY ONLINE 1078 00:41:51,400 --> 00:41:51,800 REGISTRY. 1079 00:41:51,800 --> 00:41:52,760 I'M GOING TO FOCUS FOR JUST A 1080 00:41:52,760 --> 00:41:55,040 MINUTE BEFORE I MOVE TO DOWN 1081 00:41:55,040 --> 00:41:57,560 SYNDROME ON THE LESSONS WE 1082 00:41:57,560 --> 00:41:59,360 LEARNED FROM RECRUITMENT FROM 1083 00:41:59,360 --> 00:42:01,240 THAT COMMUNITY ONLINE REGISTRY. 1084 00:42:01,240 --> 00:42:05,760 SO, IN PITTSBURGH WE HAVE A 1085 00:42:05,760 --> 00:42:07,640 PROGRAM CALLED PITT PLUS ME. 1086 00:42:07,640 --> 00:42:12,880 AND IT IS AN ONLINE REGISTRY 1087 00:42:12,880 --> 00:42:13,520 THAT HAS OVER 100,000 1088 00:42:13,520 --> 00:42:15,520 INDIVIDUALS WHO SIGNED UP FOR 1089 00:42:15,520 --> 00:42:18,560 THE REGISTRY. 1090 00:42:18,560 --> 00:42:22,280 IT LARGELY USES SOCIAL MEDIA AND 1091 00:42:22,280 --> 00:42:24,360 ONLINE MECHANISMS TO RECRUIT 1092 00:42:24,360 --> 00:42:24,800 INDIVIDUALS. 1093 00:42:24,800 --> 00:42:28,080 THIS IS AN AD FROM OUR FIRST 1094 00:42:28,080 --> 00:42:31,280 STUDY THAT FOCUSED ON 1095 00:42:31,280 --> 00:42:32,760 RECRUITMENT OF AFRICAN 1096 00:42:32,760 --> 00:42:33,200 AMERICANS. 1097 00:42:33,200 --> 00:42:35,280 THE OTHER REALLY NICE THING 1098 00:42:35,280 --> 00:42:40,080 ABOUT PITT PLUS ME IS BECAUSE OF 1099 00:42:40,080 --> 00:42:41,720 THE ADVERTISING STRATEGIES THAT 1100 00:42:41,720 --> 00:42:44,720 INCLUDE SOCIAL MEDIA, COMMUNITY 1101 00:42:44,720 --> 00:42:46,880 EVENTS, IT ALLOWED US TO FOCUS 1102 00:42:46,880 --> 00:42:54,440 ON INDIVIDUALS WHO HADN'T 1103 00:42:54,440 --> 00:42:55,520 PARTICIPATED THROUGH OTHER 1104 00:42:55,520 --> 00:43:01,760 MECHANISMS AND ALLOWED FOR 1105 00:43:01,760 --> 00:43:03,320 TARGETED RECRUITMENT. 1106 00:43:03,320 --> 00:43:05,400 WE FOCUSED IN ONE SPHERE ON 1107 00:43:05,400 --> 00:43:07,760 AFRICAN AMERICANS OVER AGE 50, 1108 00:43:07,760 --> 00:43:09,640 IN ANOTHER RECRUITMENT SPHERE WE 1109 00:43:09,640 --> 00:43:13,120 FOCUSED ON INDIVIDUALS WITH HIGH 1110 00:43:13,120 --> 00:43:15,560 SCHOOL EDUCATION OR LESS, 1111 00:43:15,560 --> 00:43:17,920 PRIMARILY INDIVIDUALS WHO ARE 1112 00:43:17,920 --> 00:43:18,840 UNDERREPRESENTED IN RESEARCH 1113 00:43:18,840 --> 00:43:19,840 STUDIES. 1114 00:43:19,840 --> 00:43:22,120 WHAT THIS ALLOWED US TO DO WAS 1115 00:43:22,120 --> 00:43:23,880 TO REALLY WORK WITH THE 1116 00:43:23,880 --> 00:43:28,800 COMMUNITY TO SORT OF BUILD A 1117 00:43:28,800 --> 00:43:29,880 NETWORK TO BUILD LONG-TERM 1118 00:43:29,880 --> 00:43:35,360 RELATIONSHIP WAS TRUST PARTNERS 1119 00:43:35,360 --> 00:43:38,840 RATHER THAN GENERAL STRATEGY 1120 00:43:38,840 --> 00:43:40,960 THAT HAS HAPPENED WHERE YOU HIT 1121 00:43:40,960 --> 00:43:43,960 AND RUN, FOLKS PARTICIPATE IN 1122 00:43:43,960 --> 00:43:45,120 RESEARCH STUDY, NOT MUCH 1123 00:43:45,120 --> 00:43:48,920 INTERACTION WITH THE COMMUNITY. 1124 00:43:48,920 --> 00:43:50,480 THROUGH PITT PLUS ME AND 1125 00:43:50,480 --> 00:43:53,320 PARTICIPANTS WE WERE ABLE TO 1126 00:43:53,320 --> 00:43:56,800 PARTNER WITH OUR COMMUNITY 1127 00:43:56,800 --> 00:43:58,760 ENGAGEMENT CENTERS, WHERE WE 1128 00:43:58,760 --> 00:44:01,160 ATTEND -- WHERE OUR RESEARCHERS 1129 00:44:01,160 --> 00:44:03,400 AND STAFF ATTEND MEETINGS, THESE 1130 00:44:03,400 --> 00:44:06,200 COMMUNITY ENGAGEMENT CENTERS IN 1131 00:44:06,200 --> 00:44:08,000 PITTSBURGH HAVE MADE COMMITMENTS 1132 00:44:08,000 --> 00:44:09,600 TO THE NEIGHBORHOODS WITHIN 1133 00:44:09,600 --> 00:44:13,320 PITTSBURGH THAT HAVE BEEN 1134 00:44:13,320 --> 00:44:14,440 HISTORICALLY EXCLUDED. 1135 00:44:14,440 --> 00:44:16,160 AND WE JUST BECAME PART OF THE 1136 00:44:16,160 --> 00:44:16,760 COMMUNITY. 1137 00:44:16,760 --> 00:44:18,880 WE ATTENDED THE DINNERS, 1138 00:44:18,880 --> 00:44:21,640 ATTENDED EVENTS, AND WE DIDN'T 1139 00:44:21,640 --> 00:44:23,840 NECESSARILY DURING THAT TIME 1140 00:44:23,840 --> 00:44:24,920 RECRUIT PARTICIPANTS. 1141 00:44:24,920 --> 00:44:27,880 RATHER, WE GOT TO KNOW THE 1142 00:44:27,880 --> 00:44:30,160 INDIVIDUALS WITHIN THE 1143 00:44:30,160 --> 00:44:31,960 COMMUNITY, PROVIDED READ SOURCES 1144 00:44:31,960 --> 00:44:35,120 LIKE INFORMATION ABOUT AGING AND 1145 00:44:35,120 --> 00:44:37,520 DEMENTIA, AND WHAT MY INTEREST 1146 00:44:37,520 --> 00:44:39,680 BECAME AFTER DOING THIS WAS THIS 1147 00:44:39,680 --> 00:44:42,720 IDEA OF HOW CAN WE APPLY THIS TO 1148 00:44:42,720 --> 00:44:44,280 OTHER COMMUNITIES. 1149 00:44:44,280 --> 00:44:50,880 AND SO A COUPLE OF THE THINGS 1150 00:44:50,880 --> 00:44:52,840 WE'VE LEARNED, FIRST IS WE HAVE 1151 00:44:52,840 --> 00:44:55,440 TO BE MORE FLEXIBLE IN OUR 1152 00:44:55,440 --> 00:44:56,640 TYPICAL CLINICAL TRIALS. 1153 00:44:56,640 --> 00:45:00,720 WE FOUND THAT AMONG THESE 1154 00:45:00,720 --> 00:45:03,320 PARTICIPANTS WHO HAVE NOT 1155 00:45:03,320 --> 00:45:04,960 PREVIOUSLY PARTICIPATED IN 1156 00:45:04,960 --> 00:45:07,200 RESEARCH, THERE'S NOT ALWAYS A 1157 00:45:07,200 --> 00:45:08,560 CONSISTENT MEANS OF CONTACT. 1158 00:45:08,560 --> 00:45:10,400 SO THESE ARE INDIVIDUALS WHO 1159 00:45:10,400 --> 00:45:12,600 FREQUENTLY CHANGE PHONE NUMBERS, 1160 00:45:12,600 --> 00:45:14,160 DON'T HAVE RELIABLE INTERNET 1161 00:45:14,160 --> 00:45:16,440 ACCESS, AND SO KEEPING CLOSE 1162 00:45:16,440 --> 00:45:17,960 CONTACT WITH INDIVIDUALS SO THAT 1163 00:45:17,960 --> 00:45:20,720 WE CAN MAINTAIN THOSE 1164 00:45:20,720 --> 00:45:22,480 RELATIONSHIPS WAS QUITE 1165 00:45:22,480 --> 00:45:29,720 DIFFERENT THAN OUR EXPERIENCE 1166 00:45:29,720 --> 00:45:30,920 WITH OUR ADRC, CLINIC-BASED 1167 00:45:30,920 --> 00:45:31,520 PARTICIPANTS. 1168 00:45:31,520 --> 00:45:34,040 WE HAD TO BE CREATIVE WITH 1169 00:45:34,040 --> 00:45:34,800 SCHEDULING, PROVIDING 1170 00:45:34,800 --> 00:45:37,520 INDIVIDUALS WITH EARLY MORNING, 1171 00:45:37,520 --> 00:45:38,960 EVENING, AND WEEKEND 1172 00:45:38,960 --> 00:45:39,440 APPOINTMENTS. 1173 00:45:39,440 --> 00:45:42,600 WE'VE ALSO FOUND THAT WHEN WE 1174 00:45:42,600 --> 00:45:44,440 CAN, WE USE TRUSTED LOCATIONS 1175 00:45:44,440 --> 00:45:45,880 FOR PROCEDURES THAT DON'T HAVE 1176 00:45:45,880 --> 00:45:50,440 TO BE AT A RESEARCH CENTER. 1177 00:45:50,440 --> 00:45:51,680 WE CAN'T BRING NEUROIMAGING 1178 00:45:51,680 --> 00:45:52,560 EQUIPMENT INTO THE COMMUNITY BUT 1179 00:45:52,560 --> 00:45:56,480 CAN GO IN THE COMMUNITY TO DO 1180 00:45:56,480 --> 00:45:59,240 SOME COGNITIVE TESTING AND TO DO 1181 00:45:59,240 --> 00:46:00,520 BLOOD DRAWS. 1182 00:46:00,520 --> 00:46:02,920 WE ALSO HAVE LEARNED THAT WE 1183 00:46:02,920 --> 00:46:06,000 NEED TO HAVE A RESPECTFUL 1184 00:46:06,000 --> 00:46:08,520 EDUCATION PROCESS ABOUT RESEARCH 1185 00:46:08,520 --> 00:46:10,840 PROCEDURES, SO WHAT DOES THAT 1186 00:46:10,840 --> 00:46:11,600 MEAN? 1187 00:46:11,600 --> 00:46:14,120 WELL, FIRST, THERE'S BEEN A LOT 1188 00:46:14,120 --> 00:46:16,200 OF DISCUSSION ABOUT WHAT 1189 00:46:16,200 --> 00:46:21,320 PARTICIPANTS WILL AND WON'T DO, 1190 00:46:21,320 --> 00:46:23,240 THERE'S ASSUMPTIONS MADE ABOUT 1191 00:46:23,240 --> 00:46:23,840 PARTICULAR COMMUNITIES BEING 1192 00:46:23,840 --> 00:46:25,600 UNWILLING TO DO PARTICULAR 1193 00:46:25,600 --> 00:46:27,880 PROCEDURES, BUT ONE OF THE 1194 00:46:27,880 --> 00:46:30,000 THINGS THAT WE'VE LEARNED AND 1195 00:46:30,000 --> 00:46:31,720 THIS IS OUR WALK INTO THE 1196 00:46:31,720 --> 00:46:34,040 INFORMED CONSENT IN A MINUTE, 1197 00:46:34,040 --> 00:46:36,520 PART OF THIS TRUST-BUILDING 1198 00:46:36,520 --> 00:46:37,880 PROCESS IS TO SPEND TIME 1199 00:46:37,880 --> 00:46:40,160 EXPLAINING WHY A PROCEDURE IS 1200 00:46:40,160 --> 00:46:41,720 NEEDED, RATHER THAN JUST 1201 00:46:41,720 --> 00:46:43,560 ASSUMING THAT WE WILL TELL 1202 00:46:43,560 --> 00:46:44,680 PARTICIPANTS, OH, THIS PROCEDURE 1203 00:46:44,680 --> 00:46:46,320 IS OPTIONAL AND YOU DON'T HAVE 1204 00:46:46,320 --> 00:46:49,400 TO DO IT. 1205 00:46:49,400 --> 00:46:50,000 SEVERAL TIMES FROM INDIVIDUALS 1206 00:46:50,000 --> 00:46:52,520 IN THE COMMUNITIES WE HEARD THAT 1207 00:46:52,520 --> 00:46:55,320 I ASSUMED IF THE PROCEDURE IS 1208 00:46:55,320 --> 00:46:56,560 OPTIONAL, IT'S NOT IMPORTANT. 1209 00:46:56,560 --> 00:46:58,800 AND SO ONE OF THE THINGS THAT WE 1210 00:46:58,800 --> 00:47:01,480 LEARNED WAS OUR INITIAL 1211 00:47:01,480 --> 00:47:02,240 ASSUMPTION WAS WE'LL TELL 1212 00:47:02,240 --> 00:47:03,360 PARTICIPANTS THEY DON'T -- THAT 1213 00:47:03,360 --> 00:47:05,560 A PET SCAN IS OPTIONAL BECAUSE 1214 00:47:05,560 --> 00:47:07,800 THEY DON'T WANT RADIATION 1215 00:47:07,800 --> 00:47:09,040 EXPOSURE, AND PARTICIPANTS WERE 1216 00:47:09,040 --> 00:47:11,680 ACTUALLY PUT OFF BY THAT BECAUSE 1217 00:47:11,680 --> 00:47:12,920 WHAT THEY WANTED TO HEAR WAS 1218 00:47:12,920 --> 00:47:15,520 WHAT WILL YOU LEARN FROM THE PET 1219 00:47:15,520 --> 00:47:15,720 SCAN? 1220 00:47:15,720 --> 00:47:18,560 WHY IS THE PET SCAN IMPORTANT? 1221 00:47:18,560 --> 00:47:19,680 AND THEN THEY CAN MAKE AN 1222 00:47:19,680 --> 00:47:21,760 INFORMED DECISION RATHER THAN 1223 00:47:21,760 --> 00:47:23,960 THIS ASSUMPTION IF IT'S OPTIONAL 1224 00:47:23,960 --> 00:47:26,240 IT MUST NOT BE IMPORTANT. 1225 00:47:26,240 --> 00:47:28,560 SO, HOW CAN WE BEGIN TO APPLY 1226 00:47:28,560 --> 00:47:31,920 SOME OF THESE STRATEGIES TO DOWN 1227 00:47:31,920 --> 00:47:32,640 SYNDROME RESEARCH? 1228 00:47:32,640 --> 00:47:34,480 WELL, IT ALL COMES DOWN TO 1229 00:47:34,480 --> 00:47:35,360 COMMUNITY ENGAGEMENT. 1230 00:47:35,360 --> 00:47:37,120 HERE I'M GOING TO REALLY FOCUS 1231 00:47:37,120 --> 00:47:38,880 IN ON INFORMED CONSENT BECAUSE 1232 00:47:38,880 --> 00:47:40,480 THAT'S WHAT TODAY'S WORKSHOP IS 1233 00:47:40,480 --> 00:47:40,840 ABOUT. 1234 00:47:40,840 --> 00:47:43,200 I JUST WANTED TO MENTION SOME OF 1235 00:47:43,200 --> 00:47:49,160 THE OTHER FACTORS THAT ARE 1236 00:47:49,160 --> 00:47:52,680 REALLY CRITICAL AND ABC-DS, 1237 00:47:52,680 --> 00:47:53,360 ALZHEIMER'S BIOMARKER CONSORTIUM 1238 00:47:53,360 --> 00:47:55,600 AND DOWN SYNDROME STUDY IN OUR 1239 00:47:55,600 --> 00:47:56,520 COMMUNITY ENGAGEMENT EFFORTS 1240 00:47:56,520 --> 00:47:59,240 WHAT WE'RE REALLY WORKING TO DO. 1241 00:47:59,240 --> 00:48:01,520 THE FIRST THING IS ENSURING 1242 00:48:01,520 --> 00:48:02,640 COMMUNITY MEMBERS WITH DOWN 1243 00:48:02,640 --> 00:48:04,160 SYNDROME AND THEIR FAMILY 1244 00:48:04,160 --> 00:48:05,400 MEMBERS AND OTHER STAKEHOLDERS 1245 00:48:05,400 --> 00:48:08,240 HAVE A SEAT AT THE TABLE. 1246 00:48:08,240 --> 00:48:12,160 SO, SEEKING FEEDBACK AT EVERY 1247 00:48:12,160 --> 00:48:14,680 STAGE OF RESEARCH, SO FROM 1248 00:48:14,680 --> 00:48:18,280 ADVERTISING AND STUDY DESIGN, 1249 00:48:18,280 --> 00:48:19,040 INFORMED CONSENT, PROCEDURES, 1250 00:48:19,040 --> 00:48:21,200 SETTING IN LOCATION OF THOSE 1251 00:48:21,200 --> 00:48:23,200 RESEARCH PROCEDURES. 1252 00:48:23,200 --> 00:48:25,320 WE HAVE TO ACKNOWLEDGE THAT THE 1253 00:48:25,320 --> 00:48:29,320 TRADITIONAL SOURCES OF DOWN 1254 00:48:29,320 --> 00:48:31,720 SYNDROME RECRUITMENT HAVE MOSTLY 1255 00:48:31,720 --> 00:48:32,640 FAILED TO ENGAGE DIVERSE 1256 00:48:32,640 --> 00:48:34,200 COMMUNITY MEMBERS. 1257 00:48:34,200 --> 00:48:39,000 SO, WE KNOW THAT GOING TO ONLY 1258 00:48:39,000 --> 00:48:41,000 SUPPORT GROUPS AND CONFERENCES 1259 00:48:41,000 --> 00:48:42,320 AND SPECIALIZED CARE PROVIDERS 1260 00:48:42,320 --> 00:48:44,560 OFTEN EXCLUDES A LARGE NUMBER OF 1261 00:48:44,560 --> 00:48:47,280 PEOPLE WHO ARE GETTING CARE IN 1262 00:48:47,280 --> 00:48:48,520 THEIR COMMUNITIES, WHO MAY NOT 1263 00:48:48,520 --> 00:48:50,760 BE ABLE TO AFFORD TO ATTEND 1264 00:48:50,760 --> 00:48:52,720 CONFERENCES OR FOR A VARIETY OF 1265 00:48:52,720 --> 00:48:58,280 REASONS MAY NOT BE ABLE TO BE AS 1266 00:48:58,280 --> 00:48:59,080 DIALED INTO THE COMMUNITY AS 1267 00:48:59,080 --> 00:49:01,200 OTHERS ARE. 1268 00:49:01,200 --> 00:49:02,600 THIS IS REALLY ABOUT MEETING THE 1269 00:49:02,600 --> 00:49:04,280 COMMUNITY WHERE THEY ARE. 1270 00:49:04,280 --> 00:49:06,240 WE HAVE TO IDENTIFY HOW RESEARCH 1271 00:49:06,240 --> 00:49:08,200 CAN BE A SERVICE TO THE 1272 00:49:08,200 --> 00:49:10,440 COMMUNITY AND I'LL COME BACK TO 1273 00:49:10,440 --> 00:49:11,960 THIS IN A MINUTE IN THE 1274 00:49:11,960 --> 00:49:12,680 DISCUSSION OF INFORMED CONSENT 1275 00:49:12,680 --> 00:49:15,240 PROCESS BECAUSE THIS IS A PLACE 1276 00:49:15,240 --> 00:49:18,400 WHERE THIS SHOULD BE A 1277 00:49:18,400 --> 00:49:18,920 DISCUSSION. 1278 00:49:18,920 --> 00:49:22,040 THESE COMMUNITIES INCLUDING THE 1279 00:49:22,040 --> 00:49:23,120 INTELLECTUAL DISABILITY 1280 00:49:23,120 --> 00:49:26,120 COMMUNITY ARE ACUTELY AWARE OF 1281 00:49:26,120 --> 00:49:36,160 THIS HIT AND RUN APPROACH. 1282 00:49:36,160 --> 00:49:37,600 DR. KRINSKI-McHALE MENTIONED 1283 00:49:37,600 --> 00:49:39,680 PAST EVENTS THAT LEFT 1284 00:49:39,680 --> 00:49:41,600 INTELLECTUAL DISABILITY 1285 00:49:41,600 --> 00:49:43,040 COMMUNITY AND UNDERREPRESENTED 1286 00:49:43,040 --> 00:49:44,800 GROUPS AWARE OF RESEARCHERS 1287 00:49:44,800 --> 00:49:46,320 TAKING AND NOT PROVIDING BACK TO 1288 00:49:46,320 --> 00:49:47,640 THE COMMUNITY. 1289 00:49:47,640 --> 00:49:49,760 WE HAVE TO IDENTIFY CHALLENGES 1290 00:49:49,760 --> 00:49:51,280 AND BARRIERS TO PARTICIPATION. 1291 00:49:51,280 --> 00:49:55,520 COSTS THAT ARE BOTH MONETARY AND 1292 00:49:55,520 --> 00:49:56,200 TIME. 1293 00:49:56,200 --> 00:49:57,960 AND THEN FINALLY, ACKNOWLEDGING 1294 00:49:57,960 --> 00:50:00,720 THAT THESE FACTORS DIFFER IN 1295 00:50:00,720 --> 00:50:01,800 DIFFERENT COMMUNITIES, AND THAT 1296 00:50:01,800 --> 00:50:05,760 WE CAN'T TAKE IN A A 1297 00:50:05,760 --> 00:50:06,400 ONE-SIZE-FITS-ALL APPROACH, 1298 00:50:06,400 --> 00:50:08,240 SOMETHING I'LL TALK ABOUT IN A 1299 00:50:08,240 --> 00:50:10,640 MINUTE, A LOT OF INFORMATION WE 1300 00:50:10,640 --> 00:50:12,400 HAVE ABOUT INFORMED CONSENT AND 1301 00:50:12,400 --> 00:50:15,000 ASSENT DOESN'T COME FROM 1302 00:50:15,000 --> 00:50:17,120 INTELLECTUAL DISABILITIES 1303 00:50:17,120 --> 00:50:17,640 COMMUNITY. 1304 00:50:17,640 --> 00:50:21,400 IT COMES FROM RESEARCH IN OTHER 1305 00:50:21,400 --> 00:50:21,640 GROUPS. 1306 00:50:21,640 --> 00:50:25,320 DR. COMBS' NEW STUDY WILL BE 1307 00:50:25,320 --> 00:50:26,520 LOOKING SPECIFICALLY AT THE DOWN 1308 00:50:26,520 --> 00:50:28,480 SYNDROME COMMUNITY, THIS IS VERY 1309 00:50:28,480 --> 00:50:30,360 IMPORTANT TO RECOGNIZE THAT JUST 1310 00:50:30,360 --> 00:50:32,120 BECAUSE SOMETHING HAS WORKED IN 1311 00:50:32,120 --> 00:50:35,080 A NEUROTYPICAL COMMUNITY OR 1312 00:50:35,080 --> 00:50:36,400 AGING COMMUNITY, THAT IT LIKELY 1313 00:50:36,400 --> 00:50:38,120 WILL HAVE TO BE MODIFIED TO 1314 00:50:38,120 --> 00:50:43,280 SUPPORT THE DOWN SYNDROME 1315 00:50:43,280 --> 00:50:43,680 COMMUNITY. 1316 00:50:43,680 --> 00:50:48,680 WHAT ABOUT INFORMED CONSENT? 1317 00:50:48,680 --> 00:50:50,440 WHAT ARE BARRIERS, MOST RESERVE 1318 00:50:50,440 --> 00:50:52,640 DOESN'T COME FROM INTELLECTUAL 1319 00:50:52,640 --> 00:50:53,640 DISABILITIES COMMUNITY ON 1320 00:50:53,640 --> 00:50:55,240 BARRIERS TO CONSENT AND 1321 00:50:55,240 --> 00:50:55,520 RESEARCH. 1322 00:50:55,520 --> 00:51:00,160 WHAT I'M MOSTLY TALKING ABOUT 1323 00:51:00,160 --> 00:51:02,920 HAS BEEN DONE IN THE 1324 00:51:02,920 --> 00:51:03,920 NEUROTYPICAL COMMUNITY BUT 1325 00:51:03,920 --> 00:51:06,640 RECENTLY THREE FACTORS HAVE BEEN 1326 00:51:06,640 --> 00:51:07,840 IDENTIFIED REAL BARRIERS TO 1327 00:51:07,840 --> 00:51:10,680 CONSENT IN RESEARCH PARTICULARLY 1328 00:51:10,680 --> 00:51:12,560 AMONG MINORITIZED RESEARCH. 1329 00:51:12,560 --> 00:51:14,280 THE FIRST IS EXISTING TRUST. 1330 00:51:14,280 --> 00:51:16,400 WHAT KIND OF TRUST DOES THE 1331 00:51:16,400 --> 00:51:21,200 COMMUNITY HAVE IN YOU AND YOUR 1332 00:51:21,200 --> 00:51:23,720 RESEARCH TEAM? 1333 00:51:23,720 --> 00:51:25,640 AND ONE QUOTE WAS AN INDIVIDUAL 1334 00:51:25,640 --> 00:51:27,840 TALKING ABOUT HOW ONCE YOU GIVE 1335 00:51:27,840 --> 00:51:29,280 BLOOD AND YOU PROVIDE CONSENT 1336 00:51:29,280 --> 00:51:32,000 FOR SOMETHING TO BE BIOBANKED, 1337 00:51:32,000 --> 00:51:34,880 THAT YOU DON'T KNOW WHAT HAPPENS 1338 00:51:34,880 --> 00:51:36,080 TO THOSE SAMPLES AFTERWARDS. 1339 00:51:36,080 --> 00:51:38,880 THAT YOU NEVER KNOW WHAT'S 1340 00:51:38,880 --> 00:51:40,800 HAPPENING IN THE LABORATORY. 1341 00:51:40,800 --> 00:51:43,760 THERE'S A LOT OF CONCERN AMONG 1342 00:51:43,760 --> 00:51:45,040 INDIVIDUALS WHEN YOU TALK -- 1343 00:51:45,040 --> 00:51:47,880 WHEN YOU GO THROUGH INFORMED 1344 00:51:47,880 --> 00:51:50,760 CONSENT AND TALK ABOUT THE LACK 1345 00:51:50,760 --> 00:51:52,160 OF COMPLETE CONFIDENTIALITY, AS 1346 00:51:52,160 --> 00:51:56,080 MANY OF US KNOW IN INFORMED 1347 00:51:56,080 --> 00:51:56,720 CONSENT DOCUMENTS WE ASSURE 1348 00:51:56,720 --> 00:51:58,840 INDIVIDUALS WE WILL DO 1349 00:51:58,840 --> 00:52:00,600 EVERYTHING TO PROTECT 1350 00:52:00,600 --> 00:52:02,040 CONFIDENTIALITY BUT THEN WE ALSO 1351 00:52:02,040 --> 00:52:03,760 SAY, AS WE'RE REQUIRED TO DO, 1352 00:52:03,760 --> 00:52:06,200 THAT THAT CAN'T BE COMPLETELY 1353 00:52:06,200 --> 00:52:10,280 PROTECTED, THAT THERE ARE EVENTS 1354 00:52:10,280 --> 00:52:12,760 THAT MAY CAUSE BREACHES IN 1355 00:52:12,760 --> 00:52:13,520 CONFIDENTIALITY. 1356 00:52:13,520 --> 00:52:14,880 THIS IS SOMETHING THAT 1357 00:52:14,880 --> 00:52:17,560 INDIVIDUALS FIND CONCERNING AND 1358 00:52:17,560 --> 00:52:20,560 SEE AS A CONTRADICTION. 1359 00:52:20,560 --> 00:52:21,880 THE PARTICIPANTS IN THIS STUDY, 1360 00:52:21,880 --> 00:52:24,200 THESE FOCUS GROUPS, ALSO 1361 00:52:24,200 --> 00:52:28,320 MENTIONED THAT THEY REALLY FEEL 1362 00:52:28,320 --> 00:52:30,080 THAT THERE'S AN IMPORTANT ROLE 1363 00:52:30,080 --> 00:52:32,560 FOR TRUSTED PARTNERS IN THE 1364 00:52:32,560 --> 00:52:35,120 CONSENT PROCESS SO IT MAY NOT BE 1365 00:52:35,120 --> 00:52:37,440 JUST A PARTICIPANT AND 1366 00:52:37,440 --> 00:52:38,280 RESEARCHER IN THE ROOM, 1367 00:52:38,280 --> 00:52:42,000 SOMETIMES IT MAY BE IMPORTANT TO 1368 00:52:42,000 --> 00:52:43,760 IDENTIFY A TRUSTED PARTNER, A 1369 00:52:43,760 --> 00:52:45,720 CARE PROVIDER FROM WITHIN THE 1370 00:52:45,720 --> 00:52:48,520 COMMUNITY, WHO CAN ALSO HELP 1371 00:52:48,520 --> 00:52:49,920 WITH INTERPRETATION OF THAT 1372 00:52:49,920 --> 00:52:51,480 INFORMED CONSENT. 1373 00:52:51,480 --> 00:52:54,160 THE SECOND FACTOR THAT HAS BEEN 1374 00:52:54,160 --> 00:52:56,680 DISCUSSED AS A BARRIER IN 1375 00:52:56,680 --> 00:52:58,040 MINORITIZED COMMUNITIES IS HOW 1376 00:52:58,040 --> 00:53:00,000 THE COMMUNITY WAS ENGAGED. 1377 00:53:00,000 --> 00:53:01,720 IF YOU'RE STUDYING AN AFRICAN 1378 00:53:01,720 --> 00:53:04,560 AMERICAN COMMUNITY, IS THERE A 1379 00:53:04,560 --> 00:53:06,440 SPECIFIC BENEFIT OF THE RESEARCH 1380 00:53:06,440 --> 00:53:07,360 TO THE AFRICAN AMERICAN 1381 00:53:07,360 --> 00:53:09,080 COMMUNITY, AND WHAT ARE THOSE 1382 00:53:09,080 --> 00:53:11,640 BENEFITS AND HOW ARE THEY 1383 00:53:11,640 --> 00:53:12,480 DESCRIBED? 1384 00:53:12,480 --> 00:53:14,280 WAS THE COMMUNITY ENGAGED IN THE 1385 00:53:14,280 --> 00:53:18,320 DEVELOPMENT OF THE RESEARCH 1386 00:53:18,320 --> 00:53:19,080 STUDY? 1387 00:53:19,080 --> 00:53:20,640 THIS HAS BECOME ESPECIALLY 1388 00:53:20,640 --> 00:53:21,200 CRITICAL. 1389 00:53:21,200 --> 00:53:22,720 AND RETURN OF RESEARCH RESULTS, 1390 00:53:22,720 --> 00:53:25,880 THIS IS ANOTHER PIECE OF 1391 00:53:25,880 --> 00:53:28,280 ENGAGEMENT THAT PARTICIPANTS 1392 00:53:28,280 --> 00:53:28,960 FIND VERY IMPORTANT AND 1393 00:53:28,960 --> 00:53:33,000 FRUSTRATING BUT THEY MAY LOSE 1394 00:53:33,000 --> 00:53:36,280 OWNERSHIP OF THE -- MAY LOSE 1395 00:53:36,280 --> 00:53:38,280 OWNERSHIP OVER THEIR RESEARCH 1396 00:53:38,280 --> 00:53:40,800 RESULTS ONCE THEY ENROLL IN A 1397 00:53:40,800 --> 00:53:42,000 RESEARCH STUDY. 1398 00:53:42,000 --> 00:53:45,920 FINALLY, AS WE ALL THINK ABOUT 1399 00:53:45,920 --> 00:53:47,240 FREQUENTLY, IS BUILDING TRUST 1400 00:53:47,240 --> 00:53:53,560 INTO THE PROCESS, AND THIS IS A 1401 00:53:53,560 --> 00:53:59,160 PLACE WHERE COLLEAGUES DISCUSS 1402 00:53:59,160 --> 00:54:00,800 IDEA OF LENGTHENING CONSENT 1403 00:54:00,800 --> 00:54:02,800 PROCESS, SO INSTEAD OF THE DAY 1404 00:54:02,800 --> 00:54:04,520 OF THE RESEARCH PROCEDURE HAVING 1405 00:54:04,520 --> 00:54:06,240 INDIVIDUALS COMING IN TO DO 1406 00:54:06,240 --> 00:54:08,200 INFORMED CONSENT, IT BECOMES AN 1407 00:54:08,200 --> 00:54:08,960 ITERATIVE PROCESS. 1408 00:54:08,960 --> 00:54:15,120 I'LL TALK ABOUT THIS MORE IN 1409 00:54:15,120 --> 00:54:18,640 JUST A SECOND. 1410 00:54:18,640 --> 00:54:21,360 WHAT HELPS WITH CONSENT 1411 00:54:21,360 --> 00:54:21,800 UNDERSTANDING? 1412 00:54:21,800 --> 00:54:23,880 IN SOME STUDIES IT'S IDENTIFIED 1413 00:54:23,880 --> 00:54:25,400 IN MINORITIZED POPULATIONS SOME 1414 00:54:25,400 --> 00:54:29,120 OF THE TERMS WE USE ACTUALLY 1415 00:54:29,120 --> 00:54:31,000 AREN'T AT ALL FAMILIAR TO 1416 00:54:31,000 --> 00:54:32,200 INDIVIDUALS IN THE LAY 1417 00:54:32,200 --> 00:54:34,960 COMMUNITY, AND THAT WHAT WE 1418 00:54:34,960 --> 00:54:37,360 THINK IS PLAIN LANGUAGE IS NOT 1419 00:54:37,360 --> 00:54:38,440 PLAIN LANGUAGE. 1420 00:54:38,440 --> 00:54:41,200 SO, LESS THAN HALF OF 1421 00:54:41,200 --> 00:54:45,240 INDIVIDUALS IN THIS PARTICULAR 1422 00:54:45,240 --> 00:54:47,680 RESEARCH STUDY WERE ABLE TO 1423 00:54:47,680 --> 00:54:53,000 CORRECTLY IDENTIFY WHAT A DOUBLE 1424 00:54:53,000 --> 00:54:54,960 BLIND STUDY WAS, NON-INVASIVE, 1425 00:54:54,960 --> 00:54:56,520 PLACEBO, EVEN WORDS LIKE 1426 00:54:56,520 --> 00:54:57,800 ANONYMOUS AND CONFIDENTIAL. 1427 00:54:57,800 --> 00:55:00,320 SO REALLY THINKING ABOUT THE 1428 00:55:00,320 --> 00:55:04,080 LANGUAGE IN YOUR CONSENT FORM 1429 00:55:04,080 --> 00:55:07,160 AND HOW IT CAN BE AS ACCESSIBLE 1430 00:55:07,160 --> 00:55:13,400 AS POSSIBLE IS REALLY A CRITICAL 1431 00:55:13,400 --> 00:55:16,360 PIECE TO ENGAGING WITH 1432 00:55:16,360 --> 00:55:18,000 COMMUNITIES IN APPROPRIATE AND 1433 00:55:18,000 --> 00:55:19,840 CULTURALLY COMPETENT WAY. 1434 00:55:19,840 --> 00:55:21,600 INTERESTINGLY IN THE SAME STUDY, 1435 00:55:21,600 --> 00:55:25,040 THEY LOOKED AT WHAT RESEARCHERS 1436 00:55:25,040 --> 00:55:26,800 FREQUENTLY DO FOR INFORMED 1437 00:55:26,800 --> 00:55:28,880 CONSENT, VERSUS WHAT COMMUNITY 1438 00:55:28,880 --> 00:55:32,840 MEMBERS MIGHT THINK WAS HELPFUL, 1439 00:55:32,840 --> 00:55:35,000 AND SO SOME THINGS THAT WE'RE 1440 00:55:35,000 --> 00:55:37,120 FAMILIAR WITH LIKE TAKING THE 1441 00:55:37,120 --> 00:55:40,400 INFORMED CONSENT HOME, SENDING 1442 00:55:40,400 --> 00:55:43,240 IT OUT TO INDIVIDUALS, A 1443 00:55:43,240 --> 00:55:44,760 ONE-ON-ONE DISCUSSION WITH AN 1444 00:55:44,760 --> 00:55:50,040 INDIVIDUAL, THOSE WERE THINGS RE 1445 00:55:50,040 --> 00:55:52,000 RESEARCHERS DO AND COMMUNITY 1446 00:55:52,000 --> 00:55:52,880 MEMBERS FIND IMPORTANT. 1447 00:55:52,880 --> 00:55:54,440 ONE THING THAT WAS INTERESTING 1448 00:55:54,440 --> 00:55:56,480 TO ME IS THAT COMMUNITY MEMBERS 1449 00:55:56,480 --> 00:56:00,680 FELT LIKE THINGS LIKE VIDEOS AND 1450 00:56:00,680 --> 00:56:02,880 GROUP DISCUSSIONS MAY BE QUITE 1451 00:56:02,880 --> 00:56:04,280 HELPFUL IN THE INFORMED CONSENT 1452 00:56:04,280 --> 00:56:12,360 PROCESS BUT THOSE WERE THINGS 1453 00:56:12,360 --> 00:56:13,560 RESEARCHERS VERY INFREQUENTLY DO 1454 00:56:13,560 --> 00:56:15,640 IN TERMS OF INFORMED CONSENT. 1455 00:56:15,640 --> 00:56:18,400 IT'S INTERESTING STRATEGY WHERE 1456 00:56:18,400 --> 00:56:19,400 SOME INDIVIDUALS READ THE 1457 00:56:19,400 --> 00:56:21,360 CONSENT TO A PARTICIPANT IS NOT 1458 00:56:21,360 --> 00:56:24,000 VIEWED TO BE EFFECTIVE BY 1459 00:56:24,000 --> 00:56:25,960 COMMUNITY MEMBERS, THAT'S NOT AT 1460 00:56:25,960 --> 00:56:27,840 LEAST IN MY OPINION SURPRISING. 1461 00:56:27,840 --> 00:56:32,440 THE LAST THING THAT I WANTED TO 1462 00:56:32,440 --> 00:56:36,080 TALK ABOUT HERE WAS THIS NEWLY 1463 00:56:36,080 --> 00:56:37,040 PUBLISHED INTERVENTION STRATEGY 1464 00:56:37,040 --> 00:56:40,120 CALLED STRIDE, WHICH STANDS FOR 1465 00:56:40,120 --> 00:56:40,680 STRENGTHENING TRANSLATIONAL 1466 00:56:40,680 --> 00:56:43,040 RESEARCH IN DIVERSE ENROLLMENT. 1467 00:56:43,040 --> 00:56:45,240 THIS WAS JUST PUBLISHED LAST 1468 00:56:45,240 --> 00:56:47,520 YEAR. 1469 00:56:47,520 --> 00:56:48,560 THERE AREN'T RESULTS FROM THE 1470 00:56:48,560 --> 00:56:50,960 STUDY YET BUT THE PROTOCOL HAS 1471 00:56:50,960 --> 00:56:51,920 NOW BEEN PUBLISHED. 1472 00:56:51,920 --> 00:56:57,640 AND ONE OF THE THINGS THAT THIS 1473 00:56:57,640 --> 00:56:59,480 STUDY UTILIZES IS MULTIPLE 1474 00:56:59,480 --> 00:56:59,720 PRONGS. 1475 00:56:59,720 --> 00:57:04,080 FIRST PRONG IS TO TRAIN RESEARCH 1476 00:57:04,080 --> 00:57:11,520 ASSISTANTS IN A CULTURALLY 1477 00:57:11,520 --> 00:57:12,880 COMPETENT MANNER IN A WAY THAT 1478 00:57:12,880 --> 00:57:15,920 IS ACCESSIVE. 1479 00:57:15,920 --> 00:57:19,440 ONE THING UTILIZED ARE 1480 00:57:19,440 --> 00:57:21,160 STORY-TELLING VIDEOS, THERE'S A 1481 00:57:21,160 --> 00:57:24,360 LOT OF INFORMATION IN 1482 00:57:24,360 --> 00:57:27,960 NEUROTYPICAL POPULATIONS IN 1483 00:57:27,960 --> 00:57:33,560 LITERATURE THAT STORY-TELLING 1484 00:57:33,560 --> 00:57:36,040 VIDEOS AND STORY TELLING OVERALL 1485 00:57:36,040 --> 00:57:39,120 IN MINORITIZED POPULATIONS IS A 1486 00:57:39,120 --> 00:57:43,280 QUITE EFFECTIVE RECRUITMENT 1487 00:57:43,280 --> 00:57:49,320 STAGE AND WAY OF SHARING 1488 00:57:49,320 --> 00:57:52,160 INFORMATION WITH MINORITIZED 1489 00:57:52,160 --> 00:57:53,680 COMMUNITIES. 1490 00:57:53,680 --> 00:57:54,560 THIS USES STORY-TELLING VIDEOS 1491 00:57:54,560 --> 00:57:56,560 IN THE INFORMED CONSENT PROCESS 1492 00:57:56,560 --> 00:57:58,040 THAT INTERACT WITH e-CONSENT 1493 00:57:58,040 --> 00:58:00,600 PLATFORM, INSTEAD OF HAVING A 1494 00:58:00,600 --> 00:58:03,640 PAPER CONSENT FORM THESE 1495 00:58:03,640 --> 00:58:05,720 INDIVIDUALS HAVE ACCESS PRIOR TO 1496 00:58:05,720 --> 00:58:07,600 THE DAY OF CONSENT AND DURING 1497 00:58:07,600 --> 00:58:14,560 THE CONSENT TO BE A INTERACTIVE 1498 00:58:14,560 --> 00:58:16,560 PLATFORM TO HAVE STORY TELLING 1499 00:58:16,560 --> 00:58:20,160 ABOUT A PARTICULAR PROCEDURE, TO 1500 00:58:20,160 --> 00:58:21,480 GET MORE INFORMATION ABOUT THE 1501 00:58:21,480 --> 00:58:24,960 PROCEDURES THAT THEY ARE 1502 00:58:24,960 --> 00:58:25,360 GETTING. 1503 00:58:25,360 --> 00:58:28,920 AND SO INSTEAD OF IT JUST BEING 1504 00:58:28,920 --> 00:58:30,960 CONVERSATIONAL, THERE'S ACTUALLY 1505 00:58:30,960 --> 00:58:32,320 MULTIMEDIA TOOLS. 1506 00:58:32,320 --> 00:58:37,440 IN THE ALZHEIMER'S BIOMARKER 1507 00:58:37,440 --> 00:58:38,520 CONSORTIUM WE WERE FUNDED TO DO 1508 00:58:38,520 --> 00:58:40,960 SOME OF THE SAME SORT OF 1509 00:58:40,960 --> 00:58:42,480 RESEARCH ASSISTANT TRAINING WITH 1510 00:58:42,480 --> 00:58:44,120 CULTURAL COMPETENCY AND THE 1511 00:58:44,120 --> 00:58:46,520 COMMUNITY, SO WE'RE HOPEFUL THAT 1512 00:58:46,520 --> 00:58:49,920 WE WILL WILL BE ABLE TO ADD TO 1513 00:58:49,920 --> 00:58:52,920 THIS BODY OF LITERATURE BY 1514 00:58:52,920 --> 00:58:56,560 EXPLORING THE RELATIONSHIP 1515 00:58:56,560 --> 00:58:57,600 BETWEEN -- EXPLORING HOW WELL 1516 00:58:57,600 --> 00:58:58,720 TRAINING OUR RESEARCH STAFF 1517 00:58:58,720 --> 00:59:02,920 WORK, HOW WELL THAT WILL WORK IN 1518 00:59:02,920 --> 00:59:04,800 RECRUITMENT OF UNDERREPRESENTED 1519 00:59:04,800 --> 00:59:05,160 INDIVIDUALS. 1520 00:59:05,160 --> 00:59:06,720 SO, IN SUMMARY, WE REALLY HAVE 1521 00:59:06,720 --> 00:59:09,160 TO THINK OF COMMUNITY ENGAGEMENT 1522 00:59:09,160 --> 00:59:10,200 AS AN ONGOING PROCESS. 1523 00:59:10,200 --> 00:59:18,080 THERE'S NOT GOING TO BE A 1524 00:59:18,080 --> 00:59:19,000 ONE-SIZE-FITS-ALL APPROACH. 1525 00:59:19,000 --> 00:59:20,680 CONSENT AS WITH OTHER PROCEDURES 1526 00:59:20,680 --> 00:59:24,320 NEEDS TO BE ONGOING AND 1527 00:59:24,320 --> 00:59:24,720 INTERACTIVE PROCESS. 1528 00:59:24,720 --> 00:59:25,520 UTILIZATION OF STORY-TELLING AND 1529 00:59:25,520 --> 00:59:27,600 COMMUNITY PARTNERS MAY BE A VERY 1530 00:59:27,600 --> 00:59:28,920 EFFECTIVE STRATEGY IN BUILDING 1531 00:59:28,920 --> 00:59:31,360 TRUST, NOT ONLY IN RECRUITMENT 1532 00:59:31,360 --> 00:59:34,160 BUT ALSO IN INFORMED CONSENT. 1533 00:59:34,160 --> 00:59:36,920 TRAINING OF TEAM MEMBERS IN 1534 00:59:36,920 --> 00:59:38,440 CULTURAL COMPETENCY IS KEY, 1535 00:59:38,440 --> 00:59:41,800 AGAIN BOTH FOR RECRUITMENT AND 1536 00:59:41,800 --> 00:59:45,120 INFORMED CONSENT, AND THEN 1537 00:59:45,120 --> 00:59:45,880 FINALLY DEMONSTRATING BENEFIT TO 1538 00:59:45,880 --> 00:59:47,440 SPECIFIC COMMUNITY THAT YOU'RE 1539 00:59:47,440 --> 00:59:48,640 REACHING TO IS CRITICAL AND THIS 1540 00:59:48,640 --> 00:59:50,160 IS REALLY SOMETHING THAT CAN BE 1541 00:59:50,160 --> 00:59:52,760 TIED IN NOT JUST TO RECRUITMENT 1542 00:59:52,760 --> 00:59:54,880 BUT ALSO TO THE INFORMED CONSENT 1543 00:59:54,880 --> 00:59:55,080 PROCESS. 1544 00:59:55,080 --> 00:59:56,920 SO THANK YOU VERY MUCH FOR 1545 00:59:56,920 --> 00:59:57,240 LISTENING. 1546 00:59:57,240 --> 00:59:58,600 IF YOU HAVE ANY QUESTIONS, 1547 00:59:58,600 --> 01:00:00,720 PLEASE FEEL FREE TO E-MAIL ME OR 1548 01:00:00,720 --> 01:00:08,760 REACH OUT TO ME ON TWITTER. 1549 01:00:08,760 --> 01:00:10,080 >> THANKS TO THE FIRST THREE 1550 01:00:10,080 --> 01:00:11,000 SPEAKERS. 1551 01:00:11,000 --> 01:00:12,800 I'LL TURN IT OVER TO ERIKA FOR 1552 01:00:12,800 --> 01:00:14,800 THE NEXT PORTION OF THE WEBINAR. 1553 01:00:14,800 --> 01:00:17,240 >> THANK YOU. 1554 01:00:17,240 --> 01:00:18,000 TO ECHO LAURIE'S POINTS, THANK 1555 01:00:18,000 --> 01:00:19,960 YOU TO THE FIRST THREE SPEAKERS. 1556 01:00:19,960 --> 01:00:22,320 WE'RE LOOKING FORWARD TO THE 1557 01:00:22,320 --> 01:00:24,720 DISCUSSION PORTION AND TO KICK 1558 01:00:24,720 --> 01:00:28,600 OFF OUR DISCUSSION PORTION WE 1559 01:00:28,600 --> 01:00:29,760 HAVE A SELF-ADVOCATE, TONY. 1560 01:00:29,760 --> 01:00:31,320 IF YOU'RE ON, IF YOU'RE ABLE TO 1561 01:00:31,320 --> 01:00:33,840 TURN ON YOUR CAMERA AND UNMUTE 1562 01:00:33,840 --> 01:00:34,720 YOURSELF, AS YOU'RE DOING THAT 1563 01:00:34,720 --> 01:00:37,000 I'LL PROVIDE A LITTLE BIT OF 1564 01:00:37,000 --> 01:00:38,760 INFORMATION TO OUR PARTICIPANTS 1565 01:00:38,760 --> 01:00:40,280 ON TONY. 1566 01:00:40,280 --> 01:00:43,040 TONY IS A 48-YEAR-OLD INDIVIDUAL 1567 01:00:43,040 --> 01:00:46,320 WHO LIVES IN NEW IBERIA, 1568 01:00:46,320 --> 01:00:47,080 LOUISIANA. 1569 01:00:47,080 --> 01:00:48,080 ACTIVE MEMBER OF NATIONAL DOWN 1570 01:00:48,080 --> 01:00:50,240 SYNDROME CONGRESS AND TONY HAS 1571 01:00:50,240 --> 01:00:52,440 SERVED ON THE NATIONAL DOWN 1572 01:00:52,440 --> 01:00:56,480 SYNDROME CONGRESS BOARD OF 1573 01:00:56,480 --> 01:00:57,480 DIRECTORS AND SELF- ADVOCATE 1574 01:00:57,480 --> 01:00:58,320 COUNCIL. 1575 01:00:58,320 --> 01:00:59,240 ONE OF HIS FAVORITE THINGS ABOUT 1576 01:00:59,240 --> 01:01:00,520 SERVING ON THE BOARD IS HE'S 1577 01:01:00,520 --> 01:01:02,600 ABLE TO SERVE AS A VOICE FOR 1578 01:01:02,600 --> 01:01:04,920 EVERYONE THAT MAY NOT HAVE THE 1579 01:01:04,920 --> 01:01:08,600 GIFT OF SPEAKING. 1580 01:01:08,600 --> 01:01:11,880 TONY IS INVOLVED WITH SEVERAL 1581 01:01:11,880 --> 01:01:14,160 COUNCIL PROJECTS INCLUDING BOOK 1582 01:01:14,160 --> 01:01:16,680 PROJECT, ADVOCACY TRAINING BOOT 1583 01:01:16,680 --> 01:01:18,800 CAMP, SERVING AS KEYNOTE SPEAKER 1584 01:01:18,800 --> 01:01:20,400 AND WORKING WITH LEADERSHIP TO 1585 01:01:20,400 --> 01:01:21,680 DEVELOP AND IMPROVE WORKSHOPS AS 1586 01:01:21,680 --> 01:01:24,440 WELL AS WORKING ON THE CONGRESS' 1587 01:01:24,440 --> 01:01:29,840 GREETERS PROGRAM AND STAFFING 1588 01:01:29,840 --> 01:01:31,080 SOME SELF-ADVOCATE INFORMATION 1589 01:01:31,080 --> 01:01:33,240 TABLE AT THE CONVENTION, A 1590 01:01:33,240 --> 01:01:36,400 FORMER BOARD MEMBER AND ADVOCATE 1591 01:01:36,400 --> 01:01:38,800 AND MOTIVATIONAL SPEAKER FOR 1592 01:01:38,800 --> 01:01:41,520 LOCAL DOWN SYNDROME 1593 01:01:41,520 --> 01:01:44,800 ORGANIZATION, DOWN SYNDROME 1594 01:01:44,800 --> 01:01:45,600 ASSOCIATION ACADENA, INVOLVED IN 1595 01:01:45,600 --> 01:01:47,680 SPECIAL OLYMPICS FOR THE STATE 1596 01:01:47,680 --> 01:01:50,600 OF LOUISIANA, ALSO A PROUD EAGLE 1597 01:01:50,600 --> 01:01:50,800 SCOUT. 1598 01:01:50,800 --> 01:01:52,080 TONY, WELCOME. 1599 01:01:52,080 --> 01:01:53,440 WE'RE HONORED TO HAVE YOU WITH 1600 01:01:53,440 --> 01:01:54,280 US TODAY. 1601 01:01:54,280 --> 01:01:55,400 >> THANK YOU VERY MUCH. 1602 01:01:55,400 --> 01:02:02,520 AND TO ALL OF YOU. 1603 01:02:02,520 --> 01:02:05,920 >> GREAT. 1604 01:02:05,920 --> 01:02:06,800 PLEASE GO AHEAD. 1605 01:02:06,800 --> 01:02:09,360 >> THANK YOU FOR THE BEAUTIFUL 1606 01:02:09,360 --> 01:02:13,920 PRODUCTION OF ME, WHICH IS SO 1607 01:02:13,920 --> 01:02:14,360 BEAUTIFUL. 1608 01:02:14,360 --> 01:02:18,960 MY PORTION, WHEN WE HAD THE NIH 1609 01:02:18,960 --> 01:02:23,560 AT THE 50th ANNIVERSARY, JUST 1610 01:02:23,560 --> 01:02:29,240 PREVIOUSLY THESE ARE SOME OF THE 1611 01:02:29,240 --> 01:02:33,120 ANSWERS THAT WE HAD TRAINED AND 1612 01:02:33,120 --> 01:02:38,240 WENT THROUGH A LOT OF. 1613 01:02:38,240 --> 01:02:38,680 >> ABSOLUTELY. 1614 01:02:38,680 --> 01:02:42,040 JUST TO START OFF, WE DO HAVE A 1615 01:02:42,040 --> 01:02:45,000 COUPLE QUESTIONS, AND THIS GOES 1616 01:02:45,000 --> 01:02:47,840 INTO SOME OF THE POINTS THAT OUR 1617 01:02:47,840 --> 01:02:48,920 THREE SPEAKERS PRESENTED. 1618 01:02:48,920 --> 01:02:50,960 THERE ARE A FEW QUESTIONS, TONY, 1619 01:02:50,960 --> 01:02:52,120 THAT I'LL ASK YOU. 1620 01:02:52,120 --> 01:02:55,520 IF YOU DON'T MIND ANSWERING. 1621 01:02:55,520 --> 01:02:55,840 >> SURE. 1622 01:02:55,840 --> 01:02:58,600 >> SO, THE FIRST QUESTION THAT 1623 01:02:58,600 --> 01:02:59,560 WE HAVE IS, TONY, COULD YOU 1624 01:02:59,560 --> 01:03:01,360 PROVIDE US WITH A LITTLE BIT OF 1625 01:03:01,360 --> 01:03:04,760 BACKGROUND ABOUT WHAT'S BEEN 1626 01:03:04,760 --> 01:03:06,720 YOUR EXPERIENCE WITH TAKING PART 1627 01:03:06,720 --> 01:03:07,920 IN CLINICAL RESEARCH. 1628 01:03:07,920 --> 01:03:09,360 >> WELL, IN THE MOST IMPORTANT 1629 01:03:09,360 --> 01:03:14,640 PART OF MY PART OF MY LIFE, WITH 1630 01:03:14,640 --> 01:03:20,200 THE CLINICAL RESEARCHERS, THAT I 1631 01:03:20,200 --> 01:03:26,360 HAVE HAD AND BEEN, YOU ARE ABLE 1632 01:03:26,360 --> 01:03:29,960 TO SEEK OUT AND APPROVE THAT 1633 01:03:29,960 --> 01:03:34,000 YOU'RE NOT ALONE. 1634 01:03:34,000 --> 01:03:34,640 >> UH-HUH. 1635 01:03:34,640 --> 01:03:39,040 >> AND WITH THAT PROVEN FOR THAT 1636 01:03:39,040 --> 01:03:41,240 FACT, THE IMPORTANCE OF LIVING A 1637 01:03:41,240 --> 01:03:45,480 NORMAL LIFE, AS OTHERS WOULD DO, 1638 01:03:45,480 --> 01:03:50,240 DOING UNTO OTHER PEOPLE AROUND 1639 01:03:50,240 --> 01:03:54,920 YOU, THAT IT'S CRITICAL AND IT'S 1640 01:03:54,920 --> 01:04:01,080 IMPORTANT TO KNOW YOU ARE LIVING 1641 01:04:01,080 --> 01:04:04,040 RESPECTFUL ADULTS, GIVING BACK. 1642 01:04:04,040 --> 01:04:05,400 THAT CAN BE ANYTHING. 1643 01:04:05,400 --> 01:04:11,000 NOT JUST TO GIVE BACK BUT THE 1644 01:04:11,000 --> 01:04:12,200 IMPORTANCE, CRITICAL PART OF 1645 01:04:12,200 --> 01:04:16,240 LIVING A FULL ACCEPTED LIFE. 1646 01:04:16,240 --> 01:04:22,280 AND I STILL DO THAT, AND IT'S SO 1647 01:04:22,280 --> 01:04:24,120 INCREDIBLE THAT I'M A BIG PART 1648 01:04:24,120 --> 01:04:32,960 OF THAT, NO MATTER WHICH WAY. 1649 01:04:32,960 --> 01:04:35,480 THE PROFESSIONALS HERE, OUR 1650 01:04:35,480 --> 01:04:36,360 ADMIRATIONS ARE ALWAYS 1651 01:04:36,360 --> 01:04:38,200 COMMENDABLE, NO MATTER WHAT OR 1652 01:04:38,200 --> 01:04:40,760 WHERE OR HOW OR WHY. 1653 01:04:40,760 --> 01:04:44,920 AND THAT'S HOW I FEEL TOO. 1654 01:04:44,920 --> 01:04:48,280 THAT'S THE IMPORTANCE OF GIVING 1655 01:04:48,280 --> 01:04:49,960 THAT BACK. 1656 01:04:49,960 --> 01:04:51,680 WE'RE RELYING ON OTHER PEOPLE, 1657 01:04:51,680 --> 01:04:53,400 WE'RE A BIG COMMUNITY, AND SO 1658 01:04:53,400 --> 01:04:57,440 MUCH MORE BECAUSE THIS IS 1659 01:04:57,440 --> 01:04:57,720 WORLDWIDE. 1660 01:04:57,720 --> 01:04:59,520 SO, YES. 1661 01:04:59,520 --> 01:04:59,880 >> PERFECT. 1662 01:04:59,880 --> 01:05:00,840 WELL, THANK YOU. 1663 01:05:00,840 --> 01:05:02,920 AND YOU KNOW, RESEARCH IS NOT 1664 01:05:02,920 --> 01:05:05,120 POSSIBLE WITHOUT PARTICIPANTS. 1665 01:05:05,120 --> 01:05:07,720 SO WE THANK YOU FOR WHAT YOU AND 1666 01:05:07,720 --> 01:05:11,200 YOUR FAMILY HAVE BEEN DOING WITH 1667 01:05:11,200 --> 01:05:11,640 RESEARCH. 1668 01:05:11,640 --> 01:05:14,520 SO, I KNOW THE LAST TIME THAT WE 1669 01:05:14,520 --> 01:05:18,360 TALKED, YOU MENTIONED THAT YOU 1670 01:05:18,360 --> 01:05:22,720 PARTICIPATED WITH THE NATIONAL 1671 01:05:22,720 --> 01:05:26,800 DOWN SYNDROME CONGRESSES, DURING 1672 01:05:26,800 --> 01:05:34,120 THE MEETINGS CRNIC INSTITUTE 1673 01:05:34,120 --> 01:05:35,400 HUMAN TRISOMY PROJECT. 1674 01:05:35,400 --> 01:05:37,280 TELL US WHAT YOU ENJOYED OR WHAT 1675 01:05:37,280 --> 01:05:39,160 DID YOU LIKE ABOUT PARTICIPATING 1676 01:05:39,160 --> 01:05:43,440 IN THAT CLINICAL RESEARCH. 1677 01:05:43,440 --> 01:05:47,360 >> WELL, THE CLINICAL RESEARCH 1678 01:05:47,360 --> 01:05:53,320 YES, NUMBER ONE, WE ARE PROBABLY 1679 01:05:53,320 --> 01:05:54,480 THE BIGGEST STAFF, MEDICAL AND 1680 01:05:54,480 --> 01:06:02,680 WHOEVER ELSE IS IN THIS BIGGER 1681 01:06:02,680 --> 01:06:04,520 PICTURE, THAT WE HAVE GROWN TO 1682 01:06:04,520 --> 01:06:07,920 BE EXCITED BUT YET INFORMATIONAL 1683 01:06:07,920 --> 01:06:09,840 AT THE SAME TIME. 1684 01:06:09,840 --> 01:06:15,480 WE CAN'T FORGET THAT PART OF 1685 01:06:15,480 --> 01:06:17,320 NOT -- OF THE ACCEPTANCE PART, 1686 01:06:17,320 --> 01:06:22,040 BUT ALSO SO MUCH MORE AFTER. 1687 01:06:22,040 --> 01:06:32,560 AND WE CAN'T ENOUGH OR DO ENOUGH 1688 01:06:32,560 --> 01:06:37,920 TO RELY ON THAT. 1689 01:06:37,920 --> 01:06:40,600 WITH THE INFORMATION WE GET AND 1690 01:06:40,600 --> 01:06:42,720 SHARE, IT'S IMPORTANT TO OUR 1691 01:06:42,720 --> 01:06:45,720 SOCIETY, WHERE WE ARE IN OUR 1692 01:06:45,720 --> 01:06:49,080 LIFE, HOW WE GOT THE ACTIVITY, 1693 01:06:49,080 --> 01:06:53,160 OR THE ACTIVITIES IN OUR LIVES, 1694 01:06:53,160 --> 01:07:01,040 WE ARE AND CAN AND WILL BE PART 1695 01:07:01,040 --> 01:07:01,680 OF THAT. 1696 01:07:01,680 --> 01:07:02,760 IT'S IMPORTANT TO HAVE THAT. 1697 01:07:02,760 --> 01:07:06,920 IF WE DON'T HAVE SCIENCE AND 1698 01:07:06,920 --> 01:07:12,680 MEDICAL, WHAT WOULD WE DO? 1699 01:07:12,680 --> 01:07:13,880 >> RIGHT. 1700 01:07:13,880 --> 01:07:15,160 >> YOU PROFESSIONALS OUT THERE, 1701 01:07:15,160 --> 01:07:17,320 YOU'RE SCRATCHING YOUR HEAD, 1702 01:07:17,320 --> 01:07:18,760 HMM, WHAT'S THE NEXT STEP? 1703 01:07:18,760 --> 01:07:21,120 AND IT WAS SO BEAUTIFUL WHEN WE 1704 01:07:21,120 --> 01:07:30,560 HAD A NEW PRESIDENT THAT CAME 1705 01:07:30,560 --> 01:07:35,360 IN, WHAT ARE YOUR QUESTIONS? 1706 01:07:35,360 --> 01:07:36,720 HE WAS SO OPEN. 1707 01:07:36,720 --> 01:07:39,480 THAT'S THE KIND OF RESPONSE, 1708 01:07:39,480 --> 01:07:41,480 TYPE OF RESPONSE TOO, TO SAY, 1709 01:07:41,480 --> 01:07:43,680 YES, YOU ARE INCLUDED. 1710 01:07:43,680 --> 01:07:52,400 YOU'RE NOT EXCLUDED BUT YOU ARE. 1711 01:07:52,400 --> 01:07:53,760 THAT'S HOW I FEEL, IT CAN NEVER 1712 01:07:53,760 --> 01:07:55,720 BE LEFT ALONE. 1713 01:07:55,720 --> 01:07:57,800 >> EXCELLENT POINT, THAT WHEN 1714 01:07:57,800 --> 01:07:59,320 THE PRESIDENT FOR THE NATIONAL 1715 01:07:59,320 --> 01:08:00,640 DOWN SYNDROME CONGRESS JOINED, 1716 01:08:00,640 --> 01:08:02,760 AS YOU MENTIONED, HE TOOK THE 1717 01:08:02,760 --> 01:08:08,560 TIME TO FIGURE OUT WHAT IT IS 1718 01:08:08,560 --> 01:08:09,240 THAT -- HOW COULD SELF-ADVOCATES 1719 01:08:09,240 --> 01:08:10,520 IN THE COMMUNITY CONTRIBUTE TO 1720 01:08:10,520 --> 01:08:14,040 SCIENCE, THAT HE WAS THERE FOR 1721 01:08:14,040 --> 01:08:14,360 THEM. 1722 01:08:14,360 --> 01:08:15,600 SIMILARLY, I KNOW THAT'S 1723 01:08:15,600 --> 01:08:22,600 SOMETHING WE CAN DO IN OUR OWN 1724 01:08:22,600 --> 01:08:24,920 CLINICAL RESEARCH ONE LAST 1725 01:08:24,920 --> 01:08:25,760 QUESTION, PERHAPS, TONY, FOR 1726 01:08:25,760 --> 01:08:27,440 YOU, IS THERE ANYTHING YOU WOULD 1727 01:08:27,440 --> 01:08:29,080 LIKE RESEARCHERS TO KNOW OR TO 1728 01:08:29,080 --> 01:08:38,160 CONSIDER WHEN PLANNING FOR 1729 01:08:38,160 --> 01:08:40,440 FUTURE STUDIES? 1730 01:08:40,440 --> 01:08:45,640 >> ME, FOR FUTURE STUDIES, 1731 01:08:45,640 --> 01:08:48,480 WILLING AND ABLE TO INTRODUCE IT 1732 01:08:48,480 --> 01:08:53,720 MORE, SHARE IT MORE. 1733 01:08:53,720 --> 01:08:56,120 THAT TYPE OF PRODUCTIVITY, TO 1734 01:08:56,120 --> 01:08:56,800 REENACT THAT. 1735 01:08:56,800 --> 01:09:05,800 ALWAYS BE PART OF THAT. 1736 01:09:05,800 --> 01:09:07,600 I KNOW ENOUGH TO BE PART OF THE 1737 01:09:07,600 --> 01:09:09,240 SECOND WONDERFUL FAMILY OF MINE. 1738 01:09:09,240 --> 01:09:11,400 THAT'S HOW I FEEL. 1739 01:09:11,400 --> 01:09:17,800 AND I HOPE ALL OF YOU OUT THERE 1740 01:09:17,800 --> 01:09:19,520 THAT ARE HEARING ME, I'M A 1741 01:09:19,520 --> 01:09:25,440 CANCER SURVIVOR, I WENT THROUGH 1742 01:09:25,440 --> 01:09:26,000 EVERYTHING. 1743 01:09:26,000 --> 01:09:30,040 I WAS ONLY BORN IN PUERTO RICO, 1744 01:09:30,040 --> 01:09:35,160 SAN JUAN, AND I KNEW NOTHING 1745 01:09:35,160 --> 01:09:45,720 UNTIL AGE OF MAYBE AT LEAST 5 OR 1746 01:09:46,200 --> 01:09:46,360 6. 1747 01:09:46,360 --> 01:09:47,880 YOU KNOW NOTHING WHEN YOU'RE 1748 01:09:47,880 --> 01:09:49,240 BORN, NO, THAT'S COMPLETELY 1749 01:09:49,240 --> 01:09:50,400 NATURAL YOU DON'T REALIZE OR SEE 1750 01:09:50,400 --> 01:09:56,080 OR RECOGNIZE OR TO ACKNOWLEDGE. 1751 01:09:56,080 --> 01:09:57,640 BUT WHEN YOU GET A LITTLE OLDER 1752 01:09:57,640 --> 01:10:04,960 YOU HAVE THAT PURPOSE IN LIFE, 1753 01:10:04,960 --> 01:10:11,800 LIKE I'VE MENTIONED, THE 1754 01:10:11,800 --> 01:10:12,840 ACKNOWLEDGMENT OF BEING YOURSELF 1755 01:10:12,840 --> 01:10:14,400 AND MOST IMPORTANTLY YOU SHARE 1756 01:10:14,400 --> 01:10:14,560 IT. 1757 01:10:14,560 --> 01:10:19,120 THERE'S TONS OF WORK, SOMEWHERE, 1758 01:10:19,120 --> 01:10:20,120 SOMEHOW, WHEREVER, WHENEVER IT 1759 01:10:20,120 --> 01:10:25,040 MIGHT TAKE PLACE IN YOUR 1760 01:10:25,040 --> 01:10:26,320 SOCIETY, CHILDREN, I STILL HEAR 1761 01:10:26,320 --> 01:10:28,280 A LOT OF THINGS THAT CAN WE DO 1762 01:10:28,280 --> 01:10:34,120 THIS, CAN WE DO THAT, HOW CAN WE 1763 01:10:34,120 --> 01:10:34,840 IMPROVE? 1764 01:10:34,840 --> 01:10:35,800 GO BACK TO THE QUESTIONS. 1765 01:10:35,800 --> 01:10:42,880 WHERE ARE WE IN LIFE? 1766 01:10:42,880 --> 01:10:44,120 WHAT'S OUR PURPOSE? 1767 01:10:44,120 --> 01:10:47,000 >> I THINK THAT'S SPOT ON. 1768 01:10:47,000 --> 01:10:49,240 IT'S REALLY IMPORTANT BECAUSE IT 1769 01:10:49,240 --> 01:10:51,320 NOT ONLY SPEAKS TO WHAT IS OUR 1770 01:10:51,320 --> 01:10:54,080 PURPOSE BUT HOW WE'RE ALSO ABLE 1771 01:10:54,080 --> 01:10:55,480 TO CONTRIBUTE TO CLINICAL 1772 01:10:55,480 --> 01:10:57,680 RESEARCH AND WE KNOW THAT 1773 01:10:57,680 --> 01:10:59,480 CONSENTING AND ASSENTING IS A 1774 01:10:59,480 --> 01:11:01,280 MAJOR PART OF THAT. 1775 01:11:01,280 --> 01:11:07,080 SO, TONY, WE THANK YOU AGAIN FOR 1776 01:11:07,080 --> 01:11:07,800 YOUR TIME. 1777 01:11:07,800 --> 01:11:10,040 >> JUST ONE MORE THING. 1778 01:11:10,040 --> 01:11:10,800 >> ABSOLUTELY. 1779 01:11:10,800 --> 01:11:11,800 >> WHILE YOU'RE ON HERE, IF 1780 01:11:11,800 --> 01:11:22,080 THERE'S ANY POSSIBLE WAY WITH 1781 01:11:22,080 --> 01:11:23,720 YOUR STAFF, A COPY OF THIS, IF 1782 01:11:23,720 --> 01:11:27,080 ANYONE OUT THERE WANTS ME TO 1783 01:11:27,080 --> 01:11:30,400 SPEAK I'D BE MORE THAN HAPPY TO, 1784 01:11:30,400 --> 01:11:35,520 IN YOUR HOMETOWN OR WHATEVER, 1785 01:11:35,520 --> 01:11:36,400 HOWEVER. 1786 01:11:36,400 --> 01:11:37,920 USE OF FLASH DRIVE, CDs, 1787 01:11:37,920 --> 01:11:39,520 HOWEVER YOUR TECHNOLOGY IS OUT 1788 01:11:39,520 --> 01:11:42,520 THERE BEING USED, I'M MORE THAN 1789 01:11:42,520 --> 01:11:44,560 HAPPY TO. 1790 01:11:44,560 --> 01:11:44,920 >> THANK YOU. 1791 01:11:44,920 --> 01:11:47,240 WE APPRECIATE THAT. 1792 01:11:47,240 --> 01:11:48,440 THAT'S VERY GENEROUS OF YOU TO 1793 01:11:48,440 --> 01:11:53,320 OFFER YOUR TIME TO DO THAT FOR 1794 01:11:53,320 --> 01:11:55,480 THE COMMUNITY. 1795 01:11:55,480 --> 01:11:57,120 >> IF ANYONE HAS EXTRA 1796 01:11:57,120 --> 01:11:59,680 QUESTIONS, LET ME KNOW. 1797 01:11:59,680 --> 01:12:00,240 >> ABSOLUTELY. 1798 01:12:00,240 --> 01:12:01,960 WELL, I KNOW THAT WE HAVE A FEW 1799 01:12:01,960 --> 01:12:03,600 QUESTIONS THAT ARE COMING IN, 1800 01:12:03,600 --> 01:12:07,240 NOT ONLY FOR YOU, TONY, BUT ALSO 1801 01:12:07,240 --> 01:12:09,960 FOR OUR SPEAKERS. 1802 01:12:09,960 --> 01:12:12,120 IF WE COULD ASK SHARON, DANNY, 1803 01:12:12,120 --> 01:12:17,080 ANN, TO TURN ON VIDEOS, AND 1804 01:12:17,080 --> 01:12:18,720 LAURIE AND MYSELF WILL 1805 01:12:18,720 --> 01:12:22,760 DEFINITELY BE SURE TO POSE THOSE 1806 01:12:22,760 --> 01:12:23,720 TO THE SPEAKERS. 1807 01:12:23,720 --> 01:12:26,480 ONE QUESTION OR COMMENT CAME IN 1808 01:12:26,480 --> 01:12:28,120 ABOUT SHARING RESULTS OF 1809 01:12:28,120 --> 01:12:30,400 RESEARCH AND, LAURIE, I'LL READ 1810 01:12:30,400 --> 01:12:30,960 THAT BRIEFLY. 1811 01:12:30,960 --> 01:12:32,840 THIS IS FOR THOSE WHO ARE 1812 01:12:32,840 --> 01:12:34,040 VIEWING THROUGH VIDEOCAST WHO 1813 01:12:34,040 --> 01:12:35,320 MAY NOT BE ABLE TO SEE THE 1814 01:12:35,320 --> 01:12:37,240 COMMENTS COMING IN THROUGH THE 1815 01:12:37,240 --> 01:12:37,560 CHAT. 1816 01:12:37,560 --> 01:12:39,960 SO, SHARING OF RESULTS OF 1817 01:12:39,960 --> 01:12:42,080 RESEARCH IS SO IMPORTANT TO 1818 01:12:42,080 --> 01:12:42,400 PARTICIPANTS. 1819 01:12:42,400 --> 01:12:44,440 IT GIVES MEANING AND 1820 01:12:44,440 --> 01:12:46,320 UNDERSTANDING TO THEIR VOLUNTARY 1821 01:12:46,320 --> 01:12:46,880 PARTICIPATION. 1822 01:12:46,880 --> 01:12:50,040 BUT OFTEN AS BUSY RESEARCHES AND 1823 01:12:50,040 --> 01:12:50,800 COORDINATORS WE FORGET THAT 1824 01:12:50,800 --> 01:12:52,000 BECAUSE WE'RE ON TO THE NEXT 1825 01:12:52,000 --> 01:12:53,960 PROJECT SO I THINK THAT'S A VERY 1826 01:12:53,960 --> 01:12:54,760 IMPORTANT POINT TO CONSIDER AND 1827 01:12:54,760 --> 01:12:57,920 I KNOW IT WAS MENTIONED BY ALL 1828 01:12:57,920 --> 01:12:59,360 THE SPEAKERS, SO MANY THANKS TO 1829 01:12:59,360 --> 01:13:02,760 YOU, TONY, FOR SHARING THAT AND 1830 01:13:02,760 --> 01:13:04,240 ALSO FOR OUR SPEAKERS. 1831 01:13:04,240 --> 01:13:07,640 LAURIE, OVER TO YOU TO ASK THE 1832 01:13:07,640 --> 01:13:08,240 FIRST QUESTION. 1833 01:13:08,240 --> 01:13:12,040 >> ABSOLUTELY. 1834 01:13:12,040 --> 01:13:13,480 FIRST QUESTION IS ACTUALLY FOR 1835 01:13:13,480 --> 01:13:16,080 SHARON, WHAT IS THE PROCESS OF 1836 01:13:16,080 --> 01:13:17,680 FINDING AN AUTHORIZED RESEARCH 1837 01:13:17,680 --> 01:13:19,720 REPRESENTATIVE, ARR, AND HOW 1838 01:13:19,720 --> 01:13:22,320 WIDELY UTILIZED AND ACCEPTED IS 1839 01:13:22,320 --> 01:13:25,560 THIS PROS FOR INFORMED CONSENT 1840 01:13:25,560 --> 01:13:27,240 FOR THOSE WITH IDD. 1841 01:13:27,240 --> 01:13:33,280 >> ACTUALLY I DON'T HAVE THE 1842 01:13:33,280 --> 01:13:34,600 ANSWER TO THAT QUESTION. 1843 01:13:34,600 --> 01:13:38,640 THIS WAS A NEW THING I SAW IN MY 1844 01:13:38,640 --> 01:13:40,920 RESEARCH FOR GIVING THIS 1845 01:13:40,920 --> 01:13:41,240 PRESENTATION. 1846 01:13:41,240 --> 01:13:44,440 SO, I'M GOING TO BE LOOKING MORE 1847 01:13:44,440 --> 01:13:47,080 INTO THAT BECAUSE I LIKE THAT 1848 01:13:47,080 --> 01:13:50,320 IDEA OF GETTING PEOPLE MORE 1849 01:13:50,320 --> 01:13:53,120 INVOLVED IN THE INFORMED CONSENT 1850 01:13:53,120 --> 01:13:53,320 PROCESS. 1851 01:13:53,320 --> 01:13:55,760 THAT'S NOT SOMETHING THAT WE 1852 01:13:55,760 --> 01:14:00,200 HAVE TRIED YET HERE IN NEW YORK 1853 01:14:00,200 --> 01:14:02,840 BECAUSE OF SOME STRINGENT IRB 1854 01:14:02,840 --> 01:14:03,280 REGULATIONS. 1855 01:14:03,280 --> 01:14:04,920 BUT IT'S AN INTERESTING CONCEPT 1856 01:14:04,920 --> 01:14:06,880 AND I THINK I WILL EXPLORE IT A 1857 01:14:06,880 --> 01:14:07,760 LITTLE BIT MORE. 1858 01:14:07,760 --> 01:14:10,880 MAYBE I'LL HAVE THE ANSWER NEXT 1859 01:14:10,880 --> 01:14:14,640 TIME WE MEET. 1860 01:14:14,640 --> 01:14:16,000 1861 01:14:16,000 --> 01:14:16,640 >> THANK YOU, SHARON. 1862 01:14:16,640 --> 01:14:19,720 NEXT QUESTION ON THE LIST IS 1863 01:14:19,720 --> 01:14:21,440 ACTUALLY FOR DR. COMBS. 1864 01:14:21,440 --> 01:14:24,520 WHEN CONSIDERING A WAIVER OF 1865 01:14:24,520 --> 01:14:25,400 ASSENT FOR NON-VERBAL 1866 01:14:25,400 --> 01:14:26,560 INDIVIDUALS, THIS IS ASSUMING 1867 01:14:26,560 --> 01:14:28,920 THE NON-VERBAL IS THE SAME AS 1868 01:14:28,920 --> 01:14:31,960 BEING UNABLE TO COMMUNICATE, 1869 01:14:31,960 --> 01:14:33,840 MANY PEOPLE WITH DOWN SYNDROME 1870 01:14:33,840 --> 01:14:36,920 OR AUTISM WITH OR WITHOUT IDD 1871 01:14:36,920 --> 01:14:41,000 ARE CAPABLE OF COMMUNICATION, 1872 01:14:41,000 --> 01:14:42,440 THOUGHTS OR IF THERE ARE 1873 01:14:42,440 --> 01:14:46,960 ACCOMMODATIONS TO ALLOW FOR 1874 01:14:46,960 --> 01:14:47,960 ASSENT FOR THOSE NON-VERBAL? 1875 01:14:47,960 --> 01:14:48,720 >> GREAT QUESTION. 1876 01:14:48,720 --> 01:14:54,000 I THINK IF YOU'RE ABLE TO USE AN 1877 01:14:54,000 --> 01:14:56,280 AAC TO COMMUNICATE, ASSENT IS 1878 01:14:56,280 --> 01:14:56,560 RELEVANT. 1879 01:14:56,560 --> 01:14:59,360 I THINK MORE IT'S THE LEVEL OF 1880 01:14:59,360 --> 01:15:03,520 AN ACTUAL DISABILITY, SEVERE 1881 01:15:03,520 --> 01:15:04,400 INTELLECTUAL DISABILITY 1882 01:15:04,400 --> 01:15:06,160 PREVENTING COMMUNICATION IS 1883 01:15:06,160 --> 01:15:08,920 DIFFERENT THAN SOMEONE WITH 1884 01:15:08,920 --> 01:15:10,400 NORMAL INTELLIGENCE WHO HAS 1885 01:15:10,400 --> 01:15:11,040 DIFFERENT COMMUNICATION ISSUES, 1886 01:15:11,040 --> 01:15:13,040 I THINK IT'S WHAT THE UNDERLYING 1887 01:15:13,040 --> 01:15:13,840 CAUSE IS. 1888 01:15:13,840 --> 01:15:17,120 I THINK IN GENERAL THE USE OF 1889 01:15:17,120 --> 01:15:18,360 AAC OR NOT SHOULDN'T PROHIBIT 1890 01:15:18,360 --> 01:15:24,920 YOU FROM GETTING ASSENT FROM 1891 01:15:24,920 --> 01:15:26,440 THAT INDIVIDUAL. 1892 01:15:26,440 --> 01:15:28,160 >> NEXT QUESTION, ANNIE, NOT TO 1893 01:15:28,160 --> 01:15:31,600 SKIP YOU, BUT I HAVE A QUESTION 1894 01:15:31,600 --> 01:15:33,040 FOR TONY. 1895 01:15:33,040 --> 01:15:34,760 TONY, YOU MENTIONED OR WE 1896 01:15:34,760 --> 01:15:37,520 DISCUSSED EARLIER THAT YOU 1897 01:15:37,520 --> 01:15:39,360 PARTICIPATE IN THE HUMAN TRISOMY 1898 01:15:39,360 --> 01:15:39,840 PROJECT. 1899 01:15:39,840 --> 01:15:43,200 WHAT DO YOU TELL YOUR FRIENDS 1900 01:15:43,200 --> 01:15:47,160 WITH DOWN SYNDROME WHO ARE 1901 01:15:47,160 --> 01:15:48,000 HESITANT TO PARTICIPATE IN 1902 01:15:48,000 --> 01:15:53,640 RESEARCH WHO MAY BE AFRAID TO 1903 01:15:53,640 --> 01:15:56,960 GET BLOOD DRAWN OR BE INVOLVED? 1904 01:15:56,960 --> 01:15:58,120 >> QUITE INTRIGUING, SMALL 1905 01:15:58,120 --> 01:16:03,120 WORLD. 1906 01:16:03,120 --> 01:16:10,240 I WAS JUST READING THAT FROM 1907 01:16:10,240 --> 01:16:14,640 MRS., OR MISS MELISSA, IF THEY 1908 01:16:14,640 --> 01:16:17,600 ARE SOMEWHAT HESITANT, GIVE US A 1909 01:16:17,600 --> 01:16:21,560 SAMPLE, LIKE BEFORE, AT SOME 1910 01:16:21,560 --> 01:16:22,160 POINT. 1911 01:16:22,160 --> 01:16:24,040 TALK TO THAT CHILD. 1912 01:16:24,040 --> 01:16:27,880 HIM OR HER. 1913 01:16:27,880 --> 01:16:37,400 I KNOW THEY MIGHT BE FRANTIC OR 1914 01:16:37,400 --> 01:16:39,280 SCARED, AND THIS, NICE TALKING 1915 01:16:39,280 --> 01:16:45,240 WITH THAT CHILD, AS YOU GO 1916 01:16:45,240 --> 01:16:49,360 ALONG, A SMALL PROCESS. 1917 01:16:49,360 --> 01:16:56,560 NOT ALL CHILDREN CAN GO THROUGH 1918 01:16:56,560 --> 01:17:01,240 THAT PART, I MEAN, FOR ME I WENT 1919 01:17:01,240 --> 01:17:02,880 THROUGH EVERYTHING SO I COULD -- 1920 01:17:02,880 --> 01:17:13,400 I MEAN, I COULD SEE IT, BUT I 1921 01:17:14,080 --> 01:17:20,560 WAS -- THE EXPERIENCE OF MY 1922 01:17:20,560 --> 01:17:21,960 LIFE, ONE THING AFTER ANOTHER. 1923 01:17:21,960 --> 01:17:23,040 I WAS YOUNG. 1924 01:17:23,040 --> 01:17:25,040 I DIDN'T KNOW IT, BUT I KNEW I 1925 01:17:25,040 --> 01:17:27,320 WAS TALKING TO PEOPLE AROUND ME, 1926 01:17:27,320 --> 01:17:32,160 OF COURSE THAT WAS HOW GOD 1927 01:17:32,160 --> 01:17:40,040 WANTED ME TO GO THROUGH ALL 1928 01:17:40,040 --> 01:17:40,360 THAT. 1929 01:17:40,360 --> 01:17:43,840 LIFE IN THAT SORT OF POSITIVE 1930 01:17:43,840 --> 01:17:44,080 RESPONSE. 1931 01:17:44,080 --> 01:17:47,800 >> DEFINITELY HAVING THE SUPPORT 1932 01:17:47,800 --> 01:17:51,640 OF YOUR FAMILY -- 1933 01:17:51,640 --> 01:17:53,520 >> OR MAYBE RELATIVES, IF ALL OF 1934 01:17:53,520 --> 01:17:56,560 YOUR FAMILY CAN'T BE THERE. 1935 01:17:56,560 --> 01:17:57,000 >> EXCELLENT POINT. 1936 01:17:57,000 --> 01:17:58,760 THANK YOU. 1937 01:17:58,760 --> 01:18:02,440 DR. COHEN, NEXT QUESTION FOR 1938 01:18:02,440 --> 01:18:02,680 YOU. 1939 01:18:02,680 --> 01:18:05,120 WOULD YOU BE ABLE TO COMMENT ON 1940 01:18:05,120 --> 01:18:12,520 THE -- YOU MENTIONED MOVING TO 1941 01:18:12,520 --> 01:18:14,200 AN E CONSENT PLATFORM, TO USING 1942 01:18:14,200 --> 01:18:17,200 OTHER TOOLS LIKE THE VIDEO OR 1943 01:18:17,200 --> 01:18:20,480 e-CONSENT PLATFORMS? 1944 01:18:20,480 --> 01:18:23,040 >> YEAH, IT'S NOT CHEAP. 1945 01:18:23,040 --> 01:18:25,960 BECAUSE IT'S GOING TO REQUIRE, 1946 01:18:25,960 --> 01:18:27,760 YOU KNOW, THERE'S THE 1947 01:18:27,760 --> 01:18:30,920 e-CONSENT ITSELF IS NOT A HUGE 1948 01:18:30,920 --> 01:18:34,000 COST OR LIFT, IT CAN BE DONE IN 1949 01:18:34,000 --> 01:18:36,400 SOME GROUPS -- SOME ARE USING 1950 01:18:36,400 --> 01:18:42,640 WEB TAP TO DO e-CONSENTS, BUT 1951 01:18:42,640 --> 01:18:45,280 THE VIDEO COMPONENT IS WHERE 1952 01:18:45,280 --> 01:18:48,440 THAT CAN BE PROHIBITIVELY 1953 01:18:48,440 --> 01:18:49,200 EXPENSIVE. 1954 01:18:49,200 --> 01:18:50,600 I THINK ONE THING THAT CAN 1955 01:18:50,600 --> 01:18:51,800 HOPEFULLY HAPPEN WITH INCLUDE 1956 01:18:51,800 --> 01:18:53,320 AND SOME LARGE STUDIES THAT MANY 1957 01:18:53,320 --> 01:18:56,440 OF US ARE A PART OF IS THAT WE 1958 01:18:56,440 --> 01:18:57,960 CAN DEVELOP CONTENT FOR SOME OF 1959 01:18:57,960 --> 01:18:59,720 THESE PROCEDURES THAT CAN THEN 1960 01:18:59,720 --> 01:19:03,920 BE USED BROADLY BY OTHER 1961 01:19:03,920 --> 01:19:04,400 RESEARCHERS. 1962 01:19:04,400 --> 01:19:07,920 AND SHARED BROADLY. 1963 01:19:07,920 --> 01:19:10,280 SO, WHILE IT CAN BE 1964 01:19:10,280 --> 01:19:11,400 PROHIBITIVELY EXPENSIVE, MY HOPE 1965 01:19:11,400 --> 01:19:12,720 IS THAT AS WE DEVELOP THESE 1966 01:19:12,720 --> 01:19:20,440 THINGS THEY CAN BE MADE 1967 01:19:20,440 --> 01:19:27,040 AVAILABLE TO THE COMMUNITY. 1968 01:19:27,040 --> 01:19:29,680 >> I KNOW THE REALITY IN LIFE 1969 01:19:29,680 --> 01:19:32,320 AND THE RESPONSIBILITY, FOR WHAT 1970 01:19:32,320 --> 01:19:35,480 SHE SAID, IS A VERY CHANGEABLE 1971 01:19:35,480 --> 01:19:38,000 THING IN LIFE. 1972 01:19:38,000 --> 01:19:44,840 AND OF COURSE CAN'T FORGET THAT 1973 01:19:44,840 --> 01:19:46,640 WHERE YOU ANSWER, WHEN, WHERE, 1974 01:19:46,640 --> 01:19:51,600 HOW, CAN YOU DO THAT, THE 1975 01:19:51,600 --> 01:19:52,640 RESOURCES, WHERE IS THAT COMING 1976 01:19:52,640 --> 01:19:54,480 FROM TOO? 1977 01:19:54,480 --> 01:19:56,760 I CAN UNDERSTAND IF YOU'RE IN 1978 01:19:56,760 --> 01:20:02,120 THE U.S., THAT'S GREAT. 1979 01:20:02,120 --> 01:20:08,880 YOU HAVE THOSE. 1980 01:20:08,880 --> 01:20:11,600 BUT LIKE MYSELF, THE COMPLETE 1981 01:20:11,600 --> 01:20:12,680 PART OF US FROM NOT JUST BEING 1982 01:20:12,680 --> 01:20:18,840 IN THE U.S. WE HAVE OUR ESPAÑOL 1983 01:20:18,840 --> 01:20:19,200 CONVENTION. 1984 01:20:19,200 --> 01:20:23,640 AND HOW ARE THEY GETTING THOSE 1985 01:20:23,640 --> 01:20:25,280 RESOURCES? 1986 01:20:25,280 --> 01:20:30,000 SO, IT'S KIND OF LIKE THAT'S AN 1987 01:20:30,000 --> 01:20:33,320 IMPASSE, AND SO LIKE WE SAY, I 1988 01:20:33,320 --> 01:20:40,200 MEAN, WHERE CAN, HOW CAN, IT 1989 01:20:40,200 --> 01:20:40,840 JUST FLOWS. 1990 01:20:40,840 --> 01:20:42,160 SINCE I BROUGHT THAT QUESTION 1991 01:20:42,160 --> 01:20:46,280 UP, BECAUSE IT'S SO IMPORTANT, 1992 01:20:46,280 --> 01:20:50,040 BECAUSE WE WANT TO SHARE THAT. 1993 01:20:50,040 --> 01:20:53,640 AND I MENTIONED IT IN THE -- 1994 01:20:53,640 --> 01:20:55,720 WITH MS. BRITTANY AND OTHERS 1995 01:20:55,720 --> 01:20:56,320 LIKE YOURSELF. 1996 01:20:56,320 --> 01:20:59,360 IF WE CAN DO SOMETHING WITH OUR 1997 01:20:59,360 --> 01:21:04,240 GROUP HERE, AND THE STAFF, WE 1998 01:21:04,240 --> 01:21:08,520 CAN FIGURE THAT OUT. 1999 01:21:08,520 --> 01:21:15,840 SOME WAY OR ANOTHER. 2000 01:21:15,840 --> 01:21:18,000 SO NOW IF ALL OF YOU ARE HEARING 2001 01:21:18,000 --> 01:21:20,000 ME, WHAT'S THE BEST WAY? 2002 01:21:20,000 --> 01:21:23,560 COULD IT BE BOTH? 2003 01:21:23,560 --> 01:21:24,440 2004 01:21:24,440 --> 01:21:28,640 THAT COULD BE PART OF YOUR 2005 01:21:28,640 --> 01:21:31,600 ANSWER RIGHT THERE. 2006 01:21:31,600 --> 01:21:32,640 NOW, I'M IN LOUISIANA. 2007 01:21:32,640 --> 01:21:39,080 IT WOULD BE HARD TO HAVE ME 2008 01:21:39,080 --> 01:21:41,520 TRAVEL UP, QUESTION MARK, MAYBE 2009 01:21:41,520 --> 01:21:44,840 THAT'S SOMETHING FOR YOU ALL, 2010 01:21:44,840 --> 01:21:48,560 D.C. STAFF, THAT COULD BE 2011 01:21:48,560 --> 01:21:53,000 SOMETHING WE COULD DO TOGETHER 2012 01:21:53,000 --> 01:21:54,120 AS A FAMILY GROUP. 2013 01:21:54,120 --> 01:21:57,960 SO WE COULD SPREAD THAT TO OUR 2014 01:21:57,960 --> 01:21:59,760 BEAUTIFUL GUESTS HERE, THAT ARE 2015 01:21:59,760 --> 01:22:01,640 ON HERE. 2016 01:22:01,640 --> 01:22:04,320 >> TONY, THAT'S A GREAT POINT. 2017 01:22:04,320 --> 01:22:08,400 YOU KNOW, LOOKING AT HOW WE'RE 2018 01:22:08,400 --> 01:22:09,360 REACHING UNDERREPRESENTED OR 2019 01:22:09,360 --> 01:22:11,320 MINORITIZED GROUPS, AS YOU 2020 01:22:11,320 --> 01:22:16,120 MENTIONED, LOOKING AT DIFFERENT 2021 01:22:16,120 --> 01:22:18,360 LANGUAGES, AND ALSO BEING 2022 01:22:18,360 --> 01:22:19,440 FLEXIBLE, TAKING INTO 2023 01:22:19,440 --> 01:22:20,200 CONSIDERATION CULTURAL 2024 01:22:20,200 --> 01:22:23,720 COMPONENTS OF EACH OF THOSE 2025 01:22:23,720 --> 01:22:25,440 GROUPS IS IMPORTANT, AND PERHAPS 2026 01:22:25,440 --> 01:22:28,640 SHARON OR ANNIE OR DAN, WE CAN 2027 01:22:28,640 --> 01:22:30,920 ASK YOU, THOSE THINGS THAT, YOU 2028 01:22:30,920 --> 01:22:33,160 KNOW, YOU ALL HAVE BEEN ABLE TO 2029 01:22:33,160 --> 01:22:35,240 UTILIZE WITHIN YOUR STUDIES. 2030 01:22:35,240 --> 01:22:40,800 I KNOW THAT BUILDING OFF OF THE 2031 01:22:40,800 --> 01:22:42,720 SEPTEMBER INCLUDE WORKSHIP, 2032 01:22:42,720 --> 01:22:46,720 DIVERSITY WORKSHOP, THERE WERE 2033 01:22:46,720 --> 01:22:47,680 IMPORTANT LESSONS WITH 2034 01:22:47,680 --> 01:22:48,440 MINORITIZED OR UNDERREPRESENTED 2035 01:22:48,440 --> 01:22:50,320 GROUPS, ARE THERE THINGS YOU'RE 2036 01:22:50,320 --> 01:22:52,200 CONSIDERING WITH REGARD TO 2037 01:22:52,200 --> 01:22:58,360 ASSENT AND CONSENT? 2038 01:22:58,360 --> 01:22:58,720 2039 01:22:58,720 --> 01:22:59,280 >> SO -- 2040 01:22:59,280 --> 01:23:00,760 >> GO FOR IT, ANNIE. 2041 01:23:00,760 --> 01:23:02,720 >> YOU GO FIRST. 2042 01:23:02,720 --> 01:23:06,120 >> I THOUGHT ANNIE'S 2043 01:23:06,120 --> 01:23:09,600 PRESENTATION WAS SO SPOT ON, 2044 01:23:09,600 --> 01:23:12,040 USING EXISTING RELATIONSHIPS. 2045 01:23:12,040 --> 01:23:15,880 IN TERMS OF CONSENT, ASSENT IN 2046 01:23:15,880 --> 01:23:17,280 PARTICULAR, OBVIOUSLY 2047 01:23:17,280 --> 01:23:18,840 TRANSLATION, ALMOST ALL OUR 2048 01:23:18,840 --> 01:23:23,720 RESEARCH STAFF SPEAKS SPANISH, 2049 01:23:23,720 --> 01:23:25,160 WHICH IS HELPFUL, UNDERSTANDING 2050 01:23:25,160 --> 01:23:26,360 THE CULTURAL CONTEXT, WHAT DOES 2051 01:23:26,360 --> 01:23:27,360 THIS MEAN. 2052 01:23:27,360 --> 01:23:30,200 I SPEAK SPANISH AS A SECOND 2053 01:23:30,200 --> 01:23:31,080 LANGUAGE, THERE ARE THINGS THAT 2054 01:23:31,080 --> 01:23:32,920 MAKE SENSE TO ME THAT ARE 2055 01:23:32,920 --> 01:23:34,800 COMPLETELY WRONG. 2056 01:23:34,800 --> 01:23:40,440 ONE THING I TRANSLATESSED, NO, 2057 01:23:40,440 --> 01:23:41,360 WHOA, HAVING CULTURAL CONFIDENCE 2058 01:23:41,360 --> 01:23:43,960 IN YOUR STAFF MAKES A HUGE 2059 01:23:43,960 --> 01:23:44,240 DIFFERENCE. 2060 01:23:44,240 --> 01:23:45,920 EVERYTHING ANNIE SAID WAS SO 2061 01:23:45,920 --> 01:23:46,840 SPOT ON. 2062 01:23:46,840 --> 01:23:50,440 >> I KNOW WHERE YOU'RE COMING 2063 01:23:50,440 --> 01:23:52,120 FROM. 2064 01:23:52,120 --> 01:23:54,040 ALL MY OTHER SIBLINGS HAVE, IF 2065 01:23:54,040 --> 01:23:56,800 GRADUATING FROM THE NAVAL 2066 01:23:56,800 --> 01:24:00,760 ACADEMY TO BEING IN A RELIGIOUS 2067 01:24:00,760 --> 01:24:02,960 ORDER, THAT WAS MY SIBLINGS, 2068 01:24:02,960 --> 01:24:07,600 FOUR OLDER SIBLINGS, TWO OLDER 2069 01:24:07,600 --> 01:24:07,960 SISTERS. 2070 01:24:07,960 --> 01:24:10,040 THEY HAD TO DO IT. 2071 01:24:10,040 --> 01:24:14,200 TO RELIVE AND LIVE THROUGH THEIR 2072 01:24:14,200 --> 01:24:16,480 BACKGROUND FOR WHAT THEIR WHOLE 2073 01:24:16,480 --> 01:24:17,880 PURPOSES WERE. 2074 01:24:17,880 --> 01:24:20,760 SO I CAN UNDERSTAND. 2075 01:24:20,760 --> 01:24:22,960 I NEVER HAD THAT CHANCE, I'M 2076 01:24:22,960 --> 01:24:24,920 CERTAINLY NOT GOING TO STOP 2077 01:24:24,920 --> 01:24:28,760 BY -- HOPEFULLY TO BE A 2078 01:24:28,760 --> 01:24:32,040 TRANSLATOR, SO FOR THE NDOC. 2079 01:24:32,040 --> 01:24:37,960 SO THAT'S ONE OF MY DREAMS, TO 2080 01:24:37,960 --> 01:24:43,120 INTERPRET. 2081 01:24:43,120 --> 01:24:46,760 >> AND, ANNIE, I DON'T KNOW IF 2082 01:24:46,760 --> 01:24:49,920 YOU HAD ANY OTHER -- 2083 01:24:49,920 --> 01:24:51,440 >> DAN SAID MUCH OF WHAT I WAS 2084 01:24:51,440 --> 01:24:53,360 GOING TO SAY, THAT WE HAVE TO 2085 01:24:53,360 --> 01:24:57,080 THINK ABOUT -- WE HAVE TO THINK 2086 01:24:57,080 --> 01:24:58,320 ABOUT TRANSLATIONS. 2087 01:24:58,320 --> 01:24:59,400 ONE OTHER THING I WANT TO 2088 01:24:59,400 --> 01:25:00,600 MENTION THOUGH THAT IS REALLY 2089 01:25:00,600 --> 01:25:01,840 IMPORTANT, WHEN WE START 2090 01:25:01,840 --> 01:25:05,320 THINKING ABOUT THINGS LIKE 2091 01:25:05,320 --> 01:25:06,120 e-CONSENTS AND VIDEOS AND 2092 01:25:06,120 --> 01:25:08,080 THINGS THAT WE WANT PEOPLE TO 2093 01:25:08,080 --> 01:25:12,560 LOOK AT, AT HOME, WE HAVE TO 2094 01:25:12,560 --> 01:25:14,400 THINK ABOUT ACCESSIBLE INTERNET, 2095 01:25:14,400 --> 01:25:17,120 AND DEVICES, AND THAT'S 2096 01:25:17,120 --> 01:25:19,080 SOMETHING MANY PEOPLE DON'T 2097 01:25:19,080 --> 01:25:19,520 HAVE. 2098 01:25:19,520 --> 01:25:22,240 AND SO IT DOES BECOME -- YOU 2099 01:25:22,240 --> 01:25:24,040 KNOW, THE ACCESSIBILITY PIECE IS 2100 01:25:24,040 --> 01:25:26,120 GOING TO ALWAYS BE CHALLENGING 2101 01:25:26,120 --> 01:25:28,400 AND SO WE HAVE TO BE FLEXIBLE IN 2102 01:25:28,400 --> 01:25:30,720 HOW WE CAN DO THESE THINGS. 2103 01:25:30,720 --> 01:25:32,320 AND WHAT SORT OF OPTIONS WE CAN 2104 01:25:32,320 --> 01:25:34,960 GIVE FOLKS. 2105 01:25:34,960 --> 01:25:37,400 2106 01:25:37,400 --> 01:25:38,720 >> WE HAVE ANOTHER QUESTION 2107 01:25:38,720 --> 01:25:40,360 THAT'S REALLY A FOLLOW-UP TO 2108 01:25:40,360 --> 01:25:40,760 THIS. 2109 01:25:40,760 --> 01:25:45,200 FOR ALL OF OUR SPEAKERS. 2110 01:25:45,200 --> 01:25:46,600 REFERRING BACK TO THE DIVERSITY 2111 01:25:46,600 --> 01:25:48,280 WORKSHOP IT WAS CLEAR THERE WAS 2112 01:25:48,280 --> 01:25:51,000 A NEED FOR MORE EDUCATIONAL 2113 01:25:51,000 --> 01:25:55,200 SESSIONS FOR PARTICIPATING IN 2114 01:25:55,200 --> 01:25:56,520 RESEARCH STUDIES, FOR 2115 01:25:56,520 --> 01:25:57,240 HARDER-TO-REACH POPULATIONS I'VE 2116 01:25:57,240 --> 01:25:59,440 HEARD USAGE OF MOBILE RESEARCH 2117 01:25:59,440 --> 01:25:59,640 UNITS. 2118 01:25:59,640 --> 01:26:01,400 HAS THIS BEEN USED IN YOUR 2119 01:26:01,400 --> 01:26:02,320 STUDIES TO REACH 2120 01:26:02,320 --> 01:26:04,920 UNDERREPRESENTED GROUPS? 2121 01:26:04,920 --> 01:26:09,640 2122 01:26:09,640 --> 01:26:09,760 2123 01:26:09,760 --> 01:26:14,440 >> SO WE HAVE NOT DONE THAT FOR 2124 01:26:14,440 --> 01:26:16,200 ABC-DS, WITH THE EXCEPTION OF 2125 01:26:16,200 --> 01:26:18,760 SOME OF THE NEUROPSYCH TESTING 2126 01:26:18,760 --> 01:26:20,680 WILL BE DONE THROUGH HOME 2127 01:26:20,680 --> 01:26:21,240 VISITS. 2128 01:26:21,240 --> 01:26:23,120 BUT THIS IS SOMETHING I THINK 2129 01:26:23,120 --> 01:26:24,640 THAT'S AN ACTIVE DISCUSSION, HOW 2130 01:26:24,640 --> 01:26:28,360 TO GO OUT INTO SOME OF THESE 2131 01:26:28,360 --> 01:26:29,400 HARD-TO-REACH COMMUNITIES, AND 2132 01:26:29,400 --> 01:26:30,640 BEGIN DEVELOPING THOSE 2133 01:26:30,640 --> 01:26:31,000 RELATIONSHIPS. 2134 01:26:31,000 --> 01:26:32,760 YOU CAN'T DO PET SCANS OR MRIs 2135 01:26:32,760 --> 01:26:34,640 IN THE COMMUNITY BUT WE CAN DO A 2136 01:26:34,640 --> 01:26:37,000 LOT OF OTHER STUFF. 2137 01:26:37,000 --> 01:26:38,680 SO HOPEFULLY WE'RE MOVING 2138 01:26:38,680 --> 01:26:41,080 TOWARDS THAT. 2139 01:26:41,080 --> 01:26:48,160 2140 01:26:48,160 --> 01:26:52,800 >> SAME FOR US, WE DO A LOT OF 2141 01:26:52,800 --> 01:26:54,200 NEUROPSYCH STUFF MOBILE. 2142 01:26:54,200 --> 01:26:55,960 SLEEP STUDIES WE DO IN THE LAB, 2143 01:26:55,960 --> 01:27:00,320 THOSE ARE IN THE LAB, THE OTHER 2144 01:27:00,320 --> 01:27:02,000 THING CAN BE HELPFUL, 2145 01:27:02,000 --> 01:27:03,440 CONSOLIDATING THINGS BY PHONE, 2146 01:27:03,440 --> 01:27:04,920 DOING THEM BY PHONE. 2147 01:27:04,920 --> 01:27:06,920 WE TRY TO MINIMIZE HOW MUCH THEY 2148 01:27:06,920 --> 01:27:08,200 HAVE TO COME IN. 2149 01:27:08,200 --> 01:27:09,880 SLEEP RESEARCH IS A PLUS BECAUSE 2150 01:27:09,880 --> 01:27:11,800 THEY HAVE SOMEWHERE TO STAY, 2151 01:27:11,800 --> 01:27:15,080 COMING IN OVERNIGHT ANYWAYS, 2152 01:27:15,080 --> 01:27:16,600 THAT TENDS TO HELP. 2153 01:27:16,600 --> 01:27:19,360 WHAT'S THE PARTICIPANT BURDEN, 2154 01:27:19,360 --> 01:27:21,000 WE CAN WE REMOVE TO MAKE THEIR 2155 01:27:21,000 --> 01:27:23,120 LIFE EASIER TO DO THE STUDY. 2156 01:27:23,120 --> 01:27:26,800 >> OUR RESEARCH HAS ALWAYS BEEN 2157 01:27:26,800 --> 01:27:27,800 VERY MOBILE BASED. 2158 01:27:27,800 --> 01:27:30,400 WE USED TO ONLY GO OUT INTO THE 2159 01:27:30,400 --> 01:27:32,280 COMMUNITY, INTO GROUP HOMES, OR 2160 01:27:32,280 --> 01:27:34,040 DAY PROGRAMS, TO DO THE 2161 01:27:34,040 --> 01:27:36,360 NEUROPSYCH, TO DO THE STUDY 2162 01:27:36,360 --> 01:27:39,880 PARTNER QUESTIONNAIRES, TO 2163 01:27:39,880 --> 01:27:40,720 COLLECT BLOOD. 2164 01:27:40,720 --> 01:27:44,320 YOU ASK TRACY AND CINDY, WHO ARE 2165 01:27:44,320 --> 01:27:45,920 OUR DATA COLLECTORS, RESEARCH 2166 01:27:45,920 --> 01:27:48,640 ASSISTANTS, THEY WILL TELL YOU 2167 01:27:48,640 --> 01:27:51,040 THEY PREFER THAT. 2168 01:27:51,040 --> 01:27:53,440 IT WAS EASIER TO GO OUT INTO THE 2169 01:27:53,440 --> 01:27:57,280 COMMUNITY THAN TO HAVE PEOPLE 2170 01:27:57,280 --> 01:27:58,280 COME TO COLUMBIA PRESBYTERIAN 2171 01:27:58,280 --> 01:28:01,560 HOSPITAL FOR A VARIETY OF 2172 01:28:01,560 --> 01:28:03,600 REASONS. 2173 01:28:03,600 --> 01:28:09,320 2174 01:28:09,320 --> 01:28:12,480 >> LOOKING AT THE TIME, I WANT 2175 01:28:12,480 --> 01:28:15,480 TO SAY THANK YOU TO THE 2176 01:28:15,480 --> 01:28:16,520 SPEAKERS, TONY, SHARON, ANNIE, 2177 01:28:16,520 --> 01:28:18,480 AND DNA, AS WELL AS TO THE 2178 01:28:18,480 --> 01:28:20,600 PARTICIPANTS AND I WOULD BE 2179 01:28:20,600 --> 01:28:23,800 REMISS IF WE DID NOT THANK THE 2180 01:28:23,800 --> 01:28:25,480 INCLUDE PROJECT COMPONENT 3 2181 01:28:25,480 --> 01:28:26,960 PLANNING GROUP FOR THIS. 2182 01:28:26,960 --> 01:28:28,240 MANY THANKS FOR YOUR SUPPORT. 2183 01:28:28,240 --> 01:28:29,760 THERE'S TOO MANY PEOPLE TO NAME. 2184 01:28:29,760 --> 01:28:33,400 IF YOU START NAMING PEOPLE YOU 2185 01:28:33,400 --> 01:28:34,760 INEVITABLY WILL MISS SOMEONE. 2186 01:28:34,760 --> 01:28:37,200 I WILL JUST SAY THANK YOU TO ALL 2187 01:28:37,200 --> 01:28:39,960 NIH STAFF AT INCLUDE. 2188 01:28:39,960 --> 01:28:42,360 IF YOU HAVE ADDITIONAL QUESTIONS 2189 01:28:42,360 --> 01:28:45,000 AS A FOLLOW-UP, PLEASE REACH OUT 2190 01:28:45,000 --> 01:28:47,160 TO SHARON, DAN, AND ANNIE. 2191 01:28:47,160 --> 01:28:49,120 THEY HAVE MADE THEIR CONTACT 2192 01:28:49,120 --> 01:28:50,680 INFORMATION AVAILABLE. 2193 01:28:50,680 --> 01:28:52,880 I KNOW TONY HAS ALSO OFFERED UP 2194 01:28:52,880 --> 01:28:55,800 HIS TIME AND IS WILLING TO SPEAK 2195 01:28:55,800 --> 01:28:58,120 AND BE AN ADVOCATE FOR RESEARCH, 2196 01:28:58,120 --> 01:29:00,080 AS WELL, NOT ONLY FOR OUR 2197 01:29:00,080 --> 01:29:02,720 RESEARCH COMMUNITY BUT ALSO TO 2198 01:29:02,720 --> 01:29:03,360 OTHER SELF-ADVOCATES. 2199 01:29:03,360 --> 01:29:07,000 MANY THANKS AGAIN TO ALL OF OUR 2200 01:29:07,000 --> 01:29:07,400 PARTICIPANTS. 2201 01:29:07,400 --> 01:29:10,440 LAURIE, OVER TO YOU FOR LAST 2202 01:29:10,440 --> 01:29:10,720 COMMENTS. 2203 01:29:10,720 --> 01:29:12,040 >> YES, YOU SAID IT ALL. 2204 01:29:12,040 --> 01:29:15,000 THANK YOU FOR THIS ABSOLUTELY 2205 01:29:15,000 --> 01:29:18,480 WONDERFUL INAUGURAL SESSION. 2206 01:29:18,480 --> 01:29:22,320 WE'RE SO GRATEFUL TO OUR SPEAKE. 2207 01:29:22,320 --> 01:29:23,640 OUR INCLUDE PROJECT COLLEAGUES, 2208 01:29:23,640 --> 01:29:25,520 WE COULDN'T DO IT WITHOUT YOU. 2209 01:29:25,520 --> 01:29:26,920 WE'RE PLANNING TO DO, HOPEFULLY, 2210 01:29:26,920 --> 01:29:28,720 ONE OF THESE A QUARTER SO THIS 2211 01:29:28,720 --> 01:29:29,520 IS OUR FIRST ONE. 2212 01:29:29,520 --> 01:29:30,400 STAY TUNED. 2213 01:29:30,400 --> 01:29:32,040 WE'LL BE LETTING YOU KNOW AND 2214 01:29:32,040 --> 01:29:34,920 WE'LL BE TAPPING SOME OF YOU 2215 01:29:34,920 --> 01:29:35,760 AGAIN TO PRESENT. 2216 01:29:35,760 --> 01:29:37,440 WE WON'T BOTHER YOU TOO MUCH. 2217 01:29:37,440 --> 01:29:38,320 WE PROMISE. 2218 01:29:38,320 --> 01:29:41,600 BUT REALLY, THANK YOU SO MUCH. 2219 01:29:41,600 --> 01:29:43,120 THIS WAS WONDERFUL. 2220 01:29:43,120 --> 01:29:44,880 EVERYONE, HOLIDAYS ARE COMING 2221 01:29:44,880 --> 01:29:45,440 UP. 2222 01:29:45,440 --> 01:29:49,200 HAPPY THANKSGIVING AND THIS 2223 01:29:49,200 --> 01:29:50,760 VIDEOCAST WILL BE AVAILABLE. 2224 01:29:50,760 --> 01:29:51,520 IF PEOPLE COULDN'T WATCH IT LET 2225 01:29:51,520 --> 01:29:52,240 THEM KNOW THEY CAN VIEW ON 2226 01:29:52,240 --> 01:29:53,880 VIDEOCAST. 2227 01:29:53,880 --> 00:00:00,000 THANKS, EVERYONE.