1 00:00:11,440 --> 00:00:13,640 Welcome to the Clinical Center Grand Rounds, 2 00:00:13,640 --> 00:00:17,440 a weekly series of educational lectures for physicians and 3 00:00:17,440 --> 00:00:20,080 health care professionals broadcast from the Clinical 4 00:00:20,080 --> 00:00:23,040 Center at the National Institutes of Health in 5 00:00:23,040 --> 00:00:24,840 Bethesda, MD. 6 00:00:24,840 --> 00:00:28,400 The NIH Clinical Center is the world's largest hospital totally 7 00:00:28,400 --> 00:00:32,080 dedicated to investigational research and leads the global 8 00:00:32,080 --> 00:00:35,040 effort in training today's investigators and discovering 9 00:00:35,040 --> 00:00:37,200 tomorrow's cures. 10 00:00:37,200 --> 00:00:46,880 Learn more by visiting us online at http://clinicalcenter.nih.gov 11 00:00:46,880 --> 00:00:50,080 I WOULD LIKE TO WELCOME 12 00:00:50,080 --> 00:00:53,040 EVERYBODY TO TODAY'S ETHICS 13 00:00:53,040 --> 00:00:53,840 GRAND ROUNDS. 14 00:00:53,840 --> 00:00:56,040 I'M DAVE FROM THE 15 00:00:56,040 --> 00:00:58,440 DEPARTMENT OF BIOTICS AT THE NIH 16 00:00:58,440 --> 00:01:00,680 CLINICAL CENTER, OUR DEPARTMENT 17 00:01:00,680 --> 00:01:03,400 HOSTS ETHICS GRAND ROUNDS 4 18 00:01:03,400 --> 00:01:05,360 TIMES A YEAR AND THE GOAL OF 19 00:01:05,360 --> 00:01:09,120 THESE SESSIONS IS TO PRESENT AND 20 00:01:09,120 --> 00:01:11,760 OFFER AN OPPORTUNITY TO DISCUSS 21 00:01:11,760 --> 00:01:13,520 IMPORTANT ETHICAL ISSUES BOTH IN 22 00:01:13,520 --> 00:01:16,360 CLINICAL CARE, CLINICAL RESEARCH 23 00:01:16,360 --> 00:01:18,360 AND ALSO IN BIOETHICS MORE 24 00:01:18,360 --> 00:01:19,960 GENERALLY. 25 00:01:19,960 --> 00:01:21,640 WE WILL TALK ABOUT THE 26 00:01:21,640 --> 00:01:22,800 ETHICS OF CLINICAL RESEARCH AND 27 00:01:22,800 --> 00:01:28,480 CLINICAL CARE WITH INDIVIDUALS 28 00:01:28,480 --> 00:01:30,560 WHO ARE IN POLICE CUSTODY. 29 00:01:30,560 --> 00:01:33,800 SO AS EVERYBODY WHO STUDIES THE 30 00:01:33,800 --> 00:01:35,760 ETHICS OF CLINICAL CARE RESEARCH 31 00:01:35,760 --> 00:01:37,840 FOR A BRIEF TIME KNOWS THAT 32 00:01:37,840 --> 00:01:39,720 INFORMED CONCEPT IS A CRITICAL 33 00:01:39,720 --> 00:01:40,840 ETHICAL APPROPRIATE TO BOTH 34 00:01:40,840 --> 00:01:43,480 APPROPRIATE CLINICAL CARE AND 35 00:01:43,480 --> 00:01:44,240 APPROPRIATE RESEARCH. 36 00:01:44,240 --> 00:01:46,760 TYPICALLY WHEN WE THINK ABOUT 37 00:01:46,760 --> 00:01:48,360 DRAWBACKS, CHALLENGES TO INFORM 38 00:01:48,360 --> 00:01:50,160 CONSENT, WE FOCUSED ON THE 39 00:01:50,160 --> 00:01:54,800 INFORMED PART THAT PEOPLE MAYBE 40 00:01:54,800 --> 00:01:57,480 DON'T NEED TO UNDERSTAND AS MUCH 41 00:01:57,480 --> 00:01:59,560 AS THEY CAN, THAT'S 1 SIDE BUT 42 00:01:59,560 --> 00:02:03,640 THERE'S ANOTHER SIDE TO INFORMED 43 00:02:03,640 --> 00:02:04,360 CONSENT, VALID CONSENT WHICH 44 00:02:04,360 --> 00:02:06,360 DOESN'T GET AS MUCH ATTENTION AS 45 00:02:06,360 --> 00:02:09,080 IT SHOULD AND THAT'S THE 46 00:02:09,080 --> 00:02:10,560 VOLUNTARY PART, IT HAS TO BE 47 00:02:10,560 --> 00:02:11,560 VOLUNTARY WHETHER IT'S FOR 48 00:02:11,560 --> 00:02:12,600 CLINICAL CARE OR RESEARCH AND 49 00:02:12,600 --> 00:02:15,040 THAT'S THE ASPECT WE WILL FOCUS 50 00:02:15,040 --> 00:02:16,480 ON TODAY, SO WHAT ARE THE 51 00:02:16,480 --> 00:02:18,080 CHALLENGES WHEN YOU HAVE 52 00:02:18,080 --> 00:02:19,720 SOMEBODY WHO'S IN POLICE 53 00:02:19,720 --> 00:02:22,760 CUSTODY, CAN YOU STILL GET AND 54 00:02:22,760 --> 00:02:24,640 HOW CAN YOU GET VOLUNTARY 55 00:02:24,640 --> 00:02:26,240 CONSENT FOR EITHER THE CLINICAL 56 00:02:26,240 --> 00:02:27,480 CARE FOR THAT ENROLLMENT IN 57 00:02:27,480 --> 00:02:27,840 RESEARCH. 58 00:02:27,840 --> 00:02:30,640 I WILL JUST SAY BRIEFLY I MIGHT 59 00:02:30,640 --> 00:02:32,440 HEAR MORE ABOUT THIS AS WE GO 60 00:02:32,440 --> 00:02:37,680 ALONG FROM OUR SPEAKERS, AS SOME 61 00:02:37,680 --> 00:02:39,480 PEOPLE KNOW, IN THE 40S, 50S, 62 00:02:39,480 --> 00:02:42,760 60S, A LOT OF RESEARCH WAS 63 00:02:42,760 --> 00:02:44,120 CONDUCTED ON INDIVIDUALS IN 64 00:02:44,120 --> 00:02:46,120 PRISONS, THEY WERE LITERALLY A 65 00:02:46,120 --> 00:02:46,920 CAPTIVE POPULATION, THERE WERE 66 00:02:46,920 --> 00:02:48,280 CONCERNS THAT THAT WAS LEADING 67 00:02:48,280 --> 00:02:49,640 TO,A BIEWSS AND STARRED STARTING 68 00:02:49,640 --> 00:02:52,880 IN THE 70S THERE WERE STRICT 69 00:02:52,880 --> 00:02:55,840 REGULATIONS ON RESEARCH AND 70 00:02:55,840 --> 00:02:56,640 PRISONERS, THOSE REGULATIONS ARE 71 00:02:56,640 --> 00:02:57,440 STRICT. 72 00:02:57,440 --> 00:02:59,000 THEY ARE MUCH AREOT SIDE OF 73 00:02:59,000 --> 00:03:01,080 PROTECTING SUBJECTS AND THEY DO 74 00:03:01,080 --> 00:03:03,160 THAT OFTEN BY NOT PERMITTING A 75 00:03:03,160 --> 00:03:05,480 LOST RESEARCH AND SO THAT RAISES 76 00:03:05,480 --> 00:03:07,480 CHALLENGES TO WHAT EXTENT DOES 77 00:03:07,480 --> 00:03:09,280 THIS QUALIFY AS PRISONERS, DO 78 00:03:09,280 --> 00:03:10,080 THE REGULATIONS APPLY TO THEM 79 00:03:10,080 --> 00:03:11,400 AND THEN WHAT DO WE DO 80 00:03:11,400 --> 00:03:13,640 PARTICULARLY IN A SETTING WHERE 81 00:03:13,640 --> 00:03:22,880 GETTING SOME CARE IN THE CONTEXT 82 00:03:22,880 --> 00:03:23,160 OF CONSENT. 83 00:03:23,160 --> 00:03:24,200 SO THESE ARE THE QUESTIONS OF 84 00:03:24,200 --> 00:03:25,160 THE DAY. 85 00:03:25,160 --> 00:03:28,960 TO LEAD US OFF IS DAVID LANG, 86 00:03:28,960 --> 00:03:31,000 DAVID IS A PHYSICIAN AT THE NIH 87 00:03:31,000 --> 00:03:33,200 CLINICAL CENTER, HE IS IN THE 88 00:03:33,200 --> 00:03:35,320 OFFICE OF THE CHIEF OF PATIENT 89 00:03:35,320 --> 00:03:36,120 SAFETY AND QUALITY. 90 00:03:36,120 --> 00:03:37,320 SO DAVID WILL PRESENT THE CASE 91 00:03:37,320 --> 00:03:39,920 AND AFTER THAT TO DISCUSS THE 92 00:03:39,920 --> 00:03:40,880 ETHICAL ISSUES RAISED BY THE 93 00:03:40,880 --> 00:03:44,080 CASE AND WE WERE JUST TALKING 94 00:03:44,080 --> 00:03:46,160 STEPHEN WILL ANSWER ABSOLUTELY 95 00:03:46,160 --> 00:03:47,360 EVERY ETHICAL QUESTION WE WOULD 96 00:03:47,360 --> 00:03:49,680 THROW AT HIM TODAY, HE'S 97 00:03:49,680 --> 00:03:51,160 PROMISED THAT'S WHAT HE'S 98 00:03:51,160 --> 00:03:53,320 GETTING PAID FOR, JUST MAKING 99 00:03:53,320 --> 00:03:56,600 THAT UP, SORRY. 100 00:03:56,600 --> 00:03:58,760 AND STEPHEN ROSENFELD, HE HAS 101 00:03:58,760 --> 00:04:00,680 WORN MORE HATSA THAN I CAN 102 00:04:00,680 --> 00:04:03,000 KOWNLT, HE'S TRAINED AS A 103 00:04:03,000 --> 00:04:04,200 HEMEATOLOGYIST, SPENT 19 YEARS 104 00:04:04,200 --> 00:04:06,040 AT THE IN, IH CLINICAL CENTER, 105 00:04:06,040 --> 00:04:07,600 HE WAS A BASIC RESEARCHER FOR A 106 00:04:07,600 --> 00:04:10,400 WHILE, HE WAS A CLINICAL 107 00:04:10,400 --> 00:04:12,120 RESEARCHER FOR A WHILE AND WENT 108 00:04:12,120 --> 00:04:13,760 INTO ADMINISTRATION AND HE ENDED 109 00:04:13,760 --> 00:04:16,640 UP WITH HIS TIME AT THE NIH AS 110 00:04:16,640 --> 00:04:18,360 THE CHIEF INFORMATION OFFICER OF 111 00:04:18,360 --> 00:04:19,080 THE CLINICAL CENTER. 112 00:04:19,080 --> 00:04:21,440 SINCE THEN HE'S GONE ON TO 113 00:04:21,440 --> 00:04:23,200 SOMETHING EVEN DIFFERENT AND NEW 114 00:04:23,200 --> 00:04:26,600 WHICH MAY BE SOMEDAY WILL BE A 115 00:04:26,600 --> 00:04:28,080 DIFFERENT ETHICS AND GRAND 116 00:04:28,080 --> 00:04:28,360 ROUNDS. 117 00:04:28,360 --> 00:04:29,840 AS SOME PEOPLE KNOW THERE ARE 118 00:04:29,840 --> 00:04:31,120 WORRIES ABOUT CONFLICTS OF 119 00:04:31,120 --> 00:04:32,880 INTEREST WITH ETHICS REVIEW AND 120 00:04:32,880 --> 00:04:34,360 IRB REVIEW, AT LEAST IN THE 121 00:04:34,360 --> 00:04:34,720 UNITED STATES. 122 00:04:34,720 --> 00:04:36,360 SO IN THE UNITED STATES, MOST 123 00:04:36,360 --> 00:04:38,000 IRBs ARE EITHER 124 00:04:38,000 --> 00:04:39,360 INSTITUTIONALLY BASED, FOR 125 00:04:39,360 --> 00:04:41,120 INSTANCE THE NIH IRBs ARE 126 00:04:41,120 --> 00:04:44,560 AFFILIATED WITH THE NIH OR FOR 127 00:04:44,560 --> 00:04:45,480 PROVEIS INDEPENDENT IRBs, AT 128 00:04:45,480 --> 00:04:47,760 LEAST SOME PEOPLE WORRY, THAT 129 00:04:47,760 --> 00:04:50,720 THOSE POTENTIAL AFFILIATIONS MAY 130 00:04:50,720 --> 00:04:52,480 LEAD TO CONFLICTS THAT LEAD THE 131 00:04:52,480 --> 00:04:54,000 CHALLENGES, CONCERNS WITH THE 132 00:04:54,000 --> 00:04:55,600 REVIEW, STEPHEN IS TRYING TO 133 00:04:55,600 --> 00:04:57,240 ADDRESS THOSE IN A VERY 134 00:04:57,240 --> 00:04:59,760 PRACTICAL WAY BY STARTING AN IRB 135 00:04:59,760 --> 00:05:02,640 THAT IS INDEPENDENT BUT NOT FOR 136 00:05:02,640 --> 00:05:05,160 PROFIT AND MAYBE WE WILL DRAG 137 00:05:05,160 --> 00:05:06,400 THEM BACK SOMEDAY TO TELL US 138 00:05:06,400 --> 00:05:08,360 ABOUT THAT EXPERIENCE, BUT FOR 139 00:05:08,360 --> 00:05:09,920 TODAY, IT'S ABOUT THE ETHICS OF 140 00:05:09,920 --> 00:05:13,080 RESEARCH AND CARE WITH 141 00:05:13,080 --> 00:05:14,760 INDIVIDUALS IN CUSTODY AND TO 142 00:05:14,760 --> 00:05:16,560 GET US STARTED IS DAVID LANG. 143 00:05:16,560 --> 00:05:17,800 OVER TO YOU DAVID. 144 00:05:17,800 --> 00:05:18,560 >>THANK YOU VERY MUCH DAVE. 145 00:05:18,560 --> 00:05:20,880 HAPPY TO BE HERE, I WOULD LIKE 146 00:05:20,880 --> 00:05:23,200 TO THANK EVERYBODY FOR 147 00:05:23,200 --> 00:05:24,280 PARTICIPATING IN TODAY'S GRAND 148 00:05:24,280 --> 00:05:25,760 ROUNDS AND FOR TUNING IN. 149 00:05:25,760 --> 00:05:26,840 JUST SHARING MY SCREEN. 150 00:05:26,840 --> 00:05:31,200 HAS MY SCREEN COME UP? 151 00:05:31,200 --> 00:05:32,720 YES. 152 00:05:32,720 --> 00:05:33,360 >>YOU LOOK GOOD. 153 00:05:33,360 --> 00:05:34,640 >>CAN YOU MAXIMIZE IT, 154 00:05:34,640 --> 00:05:36,560 EVERYTHING LOOKS GOOD FROM MY 155 00:05:36,560 --> 00:05:36,720 END. 156 00:05:36,720 --> 00:05:38,480 >>FANTASTIC, THANK YOU SO MUCH, 157 00:05:38,480 --> 00:05:40,360 ALSO AGAIN, THANK YOU EVERYBODY 158 00:05:40,360 --> 00:05:42,600 FOR JOINING TODAY AND FOR THE 159 00:05:42,600 --> 00:05:44,200 KIND INTRODUCTION. 160 00:05:44,200 --> 00:05:45,800 I DON'T HAVE ANY CONFLICT OF 161 00:05:45,800 --> 00:05:47,600 INTEREST WITH RESPECT TO THE 162 00:05:47,600 --> 00:05:48,760 PRESENT PRESENTATION. 163 00:05:48,760 --> 00:05:51,040 THIS WILL BE A CASE OF A PATIENT 164 00:05:51,040 --> 00:05:53,080 SOME OF THE DETAILS THAT ARE NOT 165 00:05:53,080 --> 00:05:56,440 RELEVANT TO THE QUESTION HAVE 166 00:05:56,440 --> 00:05:58,320 BEEN MINIMIZED OR REMOVED OR 167 00:05:58,320 --> 00:05:59,680 ANONYMIZED AND THE 168 00:05:59,680 --> 00:06:01,760 PATIENT'S--THIS IS NOT THE 169 00:06:01,760 --> 00:06:03,600 PATIENT'S REAL INITIALS SO THE 170 00:06:03,600 --> 00:06:06,320 THIS HAS ALL BEEN ANONYMIZED. 171 00:06:06,320 --> 00:06:07,920 OUR LEARNING OBJECTIVES TODAY IS 172 00:06:07,920 --> 00:06:09,440 TO DESCRIBE A CASE OF AN 173 00:06:09,440 --> 00:06:10,840 INDIVIDUAL IN POLICE CUSTODY WHO 174 00:06:10,840 --> 00:06:12,720 NEEDED MEDICAL CARE AND CONSIDER 175 00:06:12,720 --> 00:06:15,240 THE ETHICAL CHALLENGES THAT DAVE 176 00:06:15,240 --> 00:06:16,440 WENDLER JUST TEED UP A BIT ABOUT 177 00:06:16,440 --> 00:06:19,160 THE CASE AND TO DISCUSS WHEN THE 178 00:06:19,160 --> 00:06:20,040 RESOURCE REGULATIONS WOULD APPLY 179 00:06:20,040 --> 00:06:24,840 TO A PERSON WHO IS IN POLICE 180 00:06:24,840 --> 00:06:25,240 CUSTODY. 181 00:06:25,240 --> 00:06:27,320 SO THE PATIENT WE'LL IDENTIFY AS 182 00:06:27,320 --> 00:06:29,480 D. L., MIDDLE AGED MAN DIAGNOSE 183 00:06:29,480 --> 00:06:31,800 WIDE AN ACQUIRED IMMUNE 184 00:06:31,800 --> 00:06:32,880 DEFICIENCY IN 2009, THIS WAS ALL 185 00:06:32,880 --> 00:06:34,280 BEFORE HE CAME TO THE NIH. 186 00:06:34,280 --> 00:06:37,720 HE LIVES WITH RELATIVES AND ALSO 187 00:06:37,720 --> 00:06:38,400 IS INTERMITTENTLY HOMELESS 188 00:06:38,400 --> 00:06:40,160 EITHER LIVING ON THE STREETS OR 189 00:06:40,160 --> 00:06:42,160 IN SHELTERS AND DUE TO THIS, IT 190 00:06:42,160 --> 00:06:44,160 IS SOMETIMES DIFFICULT OR 191 00:06:44,160 --> 00:06:46,080 FREQUENTLY DIFFICULT TO 192 00:06:46,080 --> 00:06:49,400 COMMUNICATE WITH HIM SUCH AS YOU 193 00:06:49,400 --> 00:06:56,720 KNOW, REACHING HIM BY TELEPHONE 194 00:06:56,720 --> 00:06:58,480 MIGHT HAVE US LEAVING MESSAGES 195 00:06:58,480 --> 00:07:00,320 AT PLACES HE DOESN'T STAY 196 00:07:00,320 --> 00:07:01,240 ANYMORE. 197 00:07:01,240 --> 00:07:02,320 SO UNSTABLE COMMUNICATION. 198 00:07:02,320 --> 00:07:03,920 INITIALLY HAD DEVELOPED LESIONS 199 00:07:03,920 --> 00:07:07,960 AND SORENESS OF HIS LEFT LEG IN 200 00:07:07,960 --> 00:07:11,200 2020 WAS IN A HOSPITAL WHERE A 201 00:07:11,200 --> 00:07:12,480 SOFT TISSUE MALIGNANCY WAS 202 00:07:12,480 --> 00:07:13,560 DIAGNOSED TOWARDS THE END EVER 203 00:07:13,560 --> 00:07:16,120 TWEBT 20 AND HE WAS STARTED ON 204 00:07:16,120 --> 00:07:17,280 MEDICATION FOR HIV. 205 00:07:17,280 --> 00:07:18,480 IN THE SUBSEQUENT MONTHS HE 206 00:07:18,480 --> 00:07:21,520 CONTINUED TO BE SEEN AT THE 207 00:07:21,520 --> 00:07:23,880 OUTSIDE HOSPITALS AND HE HAD 208 00:07:23,880 --> 00:07:26,360 THINGS SUCH AS FATIGUE, WEAKNESS 209 00:07:26,360 --> 00:07:28,920 AND LEG PAIN AND WAS EVENTUALLY 210 00:07:28,920 --> 00:07:29,960 REFERRED TO THE NIH CLINICAL 211 00:07:29,960 --> 00:07:33,640 CENTER TO SCR EVALUATIONS AND 212 00:07:33,640 --> 00:07:35,480 EVALUATION OF THIS MA ILLUMINATE 213 00:07:35,480 --> 00:07:35,680 NANCY. 214 00:07:35,680 --> 00:07:37,640 HE ENROLL INDEED A RESEARCH 215 00:07:37,640 --> 00:07:40,280 PROTOCOL WHICH WAS DESIGNED TO 216 00:07:40,280 --> 00:07:41,240 PROVIDE MEDICAL TREATMENT CADRE 217 00:07:41,240 --> 00:07:44,960 OF PATIENTS FOR TRAINING AND A 218 00:07:44,960 --> 00:07:46,000 REPOSITORY OF INFORMATION BASED 219 00:07:46,000 --> 00:07:46,840 ON THESE PATIENTS. 220 00:07:46,840 --> 00:07:48,520 THERE IS NO INVESTIGATIONAL 221 00:07:48,520 --> 00:07:49,920 THERAPIES INVOLVED IN THE 222 00:07:49,920 --> 00:07:52,440 PROTOCOL AND HE SEPARATELY 223 00:07:52,440 --> 00:07:54,560 ENROLLED ON A PROTOCOL WHICH 224 00:07:54,560 --> 00:07:56,680 WOULD LOW US TO USE BLOOD, 225 00:07:56,680 --> 00:08:00,400 SAMPLES FOR RESEARCH AND TO TAKE 226 00:08:00,400 --> 00:08:02,000 TISSUE SPECIMENS FROM PROCEDURES 227 00:08:02,000 --> 00:08:02,760 OTHERWISE PERFORMED FOR MEDICAL 228 00:08:02,760 --> 00:08:04,560 REASONS THAT ARK DITIONAL TISSUE 229 00:08:04,560 --> 00:08:13,320 COULD BE USED FOR RESEARCH. 230 00:08:13,320 --> 00:08:15,120 SO FOR APPROXIMATELY 2 MONTHS 231 00:08:15,120 --> 00:08:17,760 DURING WHICH HE HAD A LYMPHOID 232 00:08:17,760 --> 00:08:20,640 BIOPSY, TREATMENT FOR HA 233 00:08:20,640 --> 00:08:28,880 LIGNANCY, FOR HIV AND CARE. 234 00:08:28,880 --> 00:08:32,920 THE TREATMENT FOR SUPPORTIVE 235 00:08:32,920 --> 00:08:33,160 CARE. 236 00:08:33,160 --> 00:08:35,600 HE ALSO HAD A SOCIAL SERVICE 237 00:08:35,600 --> 00:08:37,880 PERSON AND HE THERE WAS A PLAN 238 00:08:37,880 --> 00:08:40,080 FOR DISCHARGE TO FOLLOW UP AT 239 00:08:40,080 --> 00:08:42,760 THE NIH FOR EACH MONTH FOR 240 00:08:42,760 --> 00:08:44,400 TREATMENT FOR THE CONTINUATION 241 00:08:44,400 --> 00:08:45,000 OF CHEMO THERAPY. 242 00:08:45,000 --> 00:08:46,880 SO HE DID RETURN EACH MONTH FOR 243 00:08:46,880 --> 00:08:51,160 THE FIRST 2 MONTHS AFTER HE WAS 244 00:08:51,160 --> 00:08:52,840 DISCHARGED AT THAT TIME THE LEG 245 00:08:52,840 --> 00:08:53,880 LESION WAS IMPROVING, HE DID 246 00:08:53,880 --> 00:08:55,760 REPORT HE WAS UNABLE TO TAKE HIS 247 00:08:55,760 --> 00:08:58,520 PAIN MEDICATION BECAUSE IT WAS 248 00:08:58,520 --> 00:09:00,360 UPSETTING HIS STOMACH AND HAVING 249 00:09:00,360 --> 00:09:01,280 SUBSIDIARY QUEBT PAIN BUT 250 00:09:01,280 --> 00:09:02,480 OTHERWISE THE LESION WAS 251 00:09:02,480 --> 00:09:05,400 IMPROVING SO HE RECEIVED CHEMO 252 00:09:05,400 --> 00:09:06,600 THERAPY THAT TIME AS SCHEDULED 253 00:09:06,600 --> 00:09:08,240 AND THERE WAS A PLAN FOR HIM TO 254 00:09:08,240 --> 00:09:09,800 RETURN 2 WEEKS LATER AND THERE 255 00:09:09,800 --> 00:09:11,480 WAS DISCUSSION OF YOU KNOW 256 00:09:11,480 --> 00:09:14,160 ALTASD MATE NOR DIFFERENT 257 00:09:14,160 --> 00:09:15,400 THERAPIES BE APPROPRIATE. 258 00:09:15,400 --> 00:09:16,760 HOWEVER, HE WAS EXPECTED 2 WEEKS 259 00:09:16,760 --> 00:09:20,920 LATER AND DID NOT RETURN FOR 2 260 00:09:20,920 --> 00:09:21,880 MONTHS SO EVENTUALLY, THE TEAM 261 00:09:21,880 --> 00:09:25,120 WAS 262 00:09:25,120 --> 00:09:27,200 WAS ABLE TO CONTACT HIM BY A 263 00:09:27,200 --> 00:09:29,880 SOCIAL WORKER AND HE WAS ABLE TO 264 00:09:29,880 --> 00:09:32,200 REESTABLISH WITH THE NIH SO AN 265 00:09:32,200 --> 00:09:33,280 APPOINTMENT WAS MADE FOR HIM TO 266 00:09:33,280 --> 00:09:36,960 COME BACK AND GET WITH HIS TEAM. 267 00:09:36,960 --> 00:09:39,680 BETWEEN THE TIME HE MADE A DATE 268 00:09:39,680 --> 00:09:40,880 AND BEING TREATED HE WAS 269 00:09:40,880 --> 00:09:43,160 ADMITTED TO AN OUTSIDE HOSPITAL 270 00:09:43,160 --> 00:09:44,960 WITH FEVER, LEG PAIN AND 271 00:09:44,960 --> 00:09:45,440 SWELLING. 272 00:09:45,440 --> 00:09:48,720 AT THAT HE WAS STARTED ON 273 00:09:48,720 --> 00:09:50,320 ANTIBIOTIC TREATMENT FOR 274 00:09:50,320 --> 00:09:51,680 CELLULITIS, IT WAS DISCONTINUED 275 00:09:51,680 --> 00:09:55,600 WHEN THEY DETERMINED IT WAS A 276 00:09:55,600 --> 00:09:57,520 WORSENING OF HIS SOFT TISSUE 277 00:09:57,520 --> 00:09:58,160 MALIGNANCY. 278 00:09:58,160 --> 00:09:59,680 SO THEY CALLED THE NIH TEAM AND 279 00:09:59,680 --> 00:10:01,800 ASKED IF HE COULD RETURN HERE 280 00:10:01,800 --> 00:10:03,520 FOR TREATMENT WHICH THE MEDICAL 281 00:10:03,520 --> 00:10:05,080 TEAM AGREED, HE WAS DISCHARGED 282 00:10:05,080 --> 00:10:07,320 FROM THE OTHER HOSPITAL AND WAS 283 00:10:07,320 --> 00:10:10,840 TRANSPORTED HERE BY TAXICAB. 284 00:10:10,840 --> 00:10:14,240 ON ARRIVAL THE NIH GATE, HE WAS 285 00:10:14,240 --> 00:10:15,280 DETAINED BECAUSE WHEN HE STATED 286 00:10:15,280 --> 00:10:17,280 HIS NAME THERE WAS AN 287 00:10:17,280 --> 00:10:20,240 OUTSTANDING WARRANT FOR HIM BY 288 00:10:20,240 --> 00:10:22,640 THE NIH POLICE FOR ALLEGE THEFT 289 00:10:22,640 --> 00:10:24,960 THAT OCCURRED ON THE NIH CAMPUS 290 00:10:24,960 --> 00:10:28,280 A PRIOR TIME HE WAS HERE, WHILE 291 00:10:28,280 --> 00:10:30,880 HE'S BEING PROCESSED ISSUES THE 292 00:10:30,880 --> 00:10:32,480 POLICE DISCOVERED ANOTHER 293 00:10:32,480 --> 00:10:34,320 WARRANT FROM ANOTHER COUNTY THAT 294 00:10:34,320 --> 00:10:36,280 WAS ALSO OUTSTANDING. 295 00:10:36,280 --> 00:10:39,520 SO, THE NIH POLICE BY THEIR 296 00:10:39,520 --> 00:10:41,200 PROTOCOL CONTACTED THE ATTENDING 297 00:10:41,200 --> 00:10:42,720 PHYSICIAN WHO'S SUPPOSED TO BE 298 00:10:42,720 --> 00:10:44,600 SEEN HERE WHO DOES SAY YES, HE'S 299 00:10:44,600 --> 00:10:46,400 SUPPOSED TO BE COMING HERE FOR 300 00:10:46,400 --> 00:10:47,760 TREATMENT, HE NEEDS TREATMENT 301 00:10:47,760 --> 00:10:50,400 FOR HIS MA LIGGING NANCY BUT 302 00:10:50,400 --> 00:10:55,080 ALSO NEEDS EVALUATION FOR 303 00:10:55,080 --> 00:10:57,840 POSSIBLE DEEP VEIN THROMBOSIS, 304 00:10:57,840 --> 00:10:59,760 SO AFTER ADMISSION BROUGHT TO 305 00:10:59,760 --> 00:11:01,400 THE CLINICAL CENTER BECAUSE IT 306 00:11:01,400 --> 00:11:02,880 WAS MEDICALLY NECESSARY UNDER 307 00:11:02,880 --> 00:11:03,520 POLICE CUSTODY. 308 00:11:03,520 --> 00:11:06,320 HE WAS THEN HOSPITALIZED AT THE 309 00:11:06,320 --> 00:11:07,920 NIH HOSPITAL CENTER FOR 10 DAYS 310 00:11:07,920 --> 00:11:11,080 AND UNDER POLICE CAN CUSTODY FOR 311 00:11:11,080 --> 00:11:12,760 FIRST 2 DAYS, WHILE HE WAS IN 312 00:11:12,760 --> 00:11:14,520 THE IN-PATIENT UNIT FOR THE 313 00:11:14,520 --> 00:11:17,680 FIRST 2 DAYS UNTIL THERE WAS 314 00:11:17,680 --> 00:11:20,360 SOME CLEAR UP THINGS WITH THE 315 00:11:20,360 --> 00:11:22,160 WARRANT, SO THERE WAS PERMISSION 316 00:11:22,160 --> 00:11:25,640 TO NOT HAVE HIM BE UNDER POLICE 317 00:11:25,640 --> 00:11:26,040 CUSTODY. 318 00:11:26,040 --> 00:11:29,080 WHILE HE WAS HERE HE GOT HIS 319 00:11:29,080 --> 00:11:30,640 NEXT CYCLE OF CHEMO HER TAPY AND 320 00:11:30,640 --> 00:11:32,080 WHILE HE WAS HERE, THERE WERE 321 00:11:32,080 --> 00:11:33,280 PLANS MADE FOR HIM AND HE WAS 322 00:11:33,280 --> 00:11:36,200 GOING TO BE DISCHARGED AND ON 323 00:11:36,200 --> 00:11:38,000 THE DAY OF DISCHARGE HE LEFT THE 324 00:11:38,000 --> 00:11:38,920 CLINICAL CENTER BEFORE HE WAS 325 00:11:38,920 --> 00:11:40,720 ABLE TO PICK UP HIS MEDICATIONS 326 00:11:40,720 --> 00:11:42,720 AND BEFORE THE NIH POLICE WERE 327 00:11:42,720 --> 00:11:44,280 ABLE TO COME AND SPEAK WITH HIM 328 00:11:44,280 --> 00:11:49,760 BEFORE THE NEXT STEPS AS FAR AS 329 00:11:49,760 --> 00:11:50,240 THE WARRANTS. 330 00:11:50,240 --> 00:11:51,960 SO THE NIH SOCIAL WORKER CALLED 331 00:11:51,960 --> 00:11:54,200 HIM ONCE SHE WAS ABLE TO CONTACT 332 00:11:54,200 --> 00:11:55,840 HIM HE STATED THAT HE FELT THAT 333 00:11:55,840 --> 00:11:58,280 THE NIH TRAPPED HIM INTO COMING 334 00:11:58,280 --> 00:11:59,920 UP HERE BECAUSE HE THOUGHT THE 335 00:11:59,920 --> 00:12:03,240 NIH TEAM WOULD HAVE KNOWN THOSE 336 00:12:03,240 --> 00:12:04,760 WARRANTS WOULD LIKELY RESULT IN 337 00:12:04,760 --> 00:12:06,320 HIS ARREST AND HE FELT TRAPPED. 338 00:12:06,320 --> 00:12:08,640 THE SOCIAL WORKERS STATED THEY 339 00:12:08,640 --> 00:12:10,400 HAD WERE TOTAL UNAWARE OF THE 340 00:12:10,400 --> 00:12:12,080 WARRANTS UNTIL HE GOT HERE AND 341 00:12:12,080 --> 00:12:13,200 THEY WERE CONTACTED ABOUT THEM 342 00:12:13,200 --> 00:12:14,520 AND THEY HAD ACCEPTED HIM FOR 343 00:12:14,520 --> 00:12:15,600 THE MEDICAL TREATMENT AND THEY 344 00:12:15,600 --> 00:12:18,760 DIDN'T KNOW ANYTHING ABOUT HIS 345 00:12:18,760 --> 00:12:25,160 LEGAL PROBLEMS OR ISSUES. 346 00:12:25,160 --> 00:12:26,360 AT THE TIME THEY CONTINUE TO 347 00:12:26,360 --> 00:12:30,320 WORK WITH HIM AND HELP HIM WITH 348 00:12:30,320 --> 00:12:31,760 ACCESSING LOCAL HOUSING AND 349 00:12:31,760 --> 00:12:32,480 SOCIAL SERVICES AND MEDICAL 350 00:12:32,480 --> 00:12:32,680 CARE. 351 00:12:32,680 --> 00:12:34,800 SO THIS LED TO SOME QUESTIONS, 352 00:12:34,800 --> 00:12:35,760 BECAUSE WE'RE HONESTLY NOT USED 353 00:12:35,760 --> 00:12:37,440 TO HAVING A PATIENT WHO'S UNDER 354 00:12:37,440 --> 00:12:38,480 ARREST HERE AT THE CLINICAL 355 00:12:38,480 --> 00:12:42,880 CENTER AND THE FIRST WAS DOES 356 00:12:42,880 --> 00:12:44,520 THIS AFFECT HOW ANY CLINICAL 357 00:12:44,520 --> 00:12:46,120 CARE IS PROVIDED TO INDIVIDUALS 358 00:12:46,120 --> 00:12:48,600 UNDER ARREST AND HIM BEING IN 359 00:12:48,600 --> 00:12:50,520 CUSTODY OR BEING UNDER ARREST 360 00:12:50,520 --> 00:12:51,840 INFLUENCE ANY SPECIFIC ISSUES 361 00:12:51,840 --> 00:12:55,440 LIKE IS HE ABLE TO CONSENT FOR 362 00:12:55,440 --> 00:12:56,400 INVASIVE PROCEDURES, OR OTHER 363 00:12:56,400 --> 00:12:58,480 SAFE GUARDS NEED TO BE TAKEN. 364 00:12:58,480 --> 00:13:02,600 IF HE WERE TO SAY, I WANT TO BE 365 00:13:02,600 --> 00:13:04,000 DNR, WOULD THERE BE ANY OTHER 366 00:13:04,000 --> 00:13:05,560 PROCEDURES THAT NEED TO BE TAKEN 367 00:13:05,560 --> 00:13:07,480 CARE OF LIKE THAT. 368 00:13:07,480 --> 00:13:09,240 RELATING TO RESEARCH, DO THE 369 00:13:09,240 --> 00:13:10,760 REGULATIONS WHICH APPLY TO 370 00:13:10,760 --> 00:13:11,880 RESEARCH ON PRISONERS APPLY TO 371 00:13:11,880 --> 00:13:13,280 IA PERSON WHO'S SORT OF JUST 372 00:13:13,280 --> 00:13:15,760 BEEN ARRESTED AT THE TIME. 373 00:13:15,760 --> 00:13:17,520 IS THE CLINICAL CENTER,A LOWED 374 00:13:17,520 --> 00:13:19,560 TO PROCEED WITH THE RESEARCH 375 00:13:19,560 --> 00:13:22,240 PROTOCOL WITH A PERSON WHO HAS 376 00:13:22,240 --> 00:13:23,520 BEEN ARRESTED AND WOULD IT 377 00:13:23,520 --> 00:13:25,480 MATTER IF THAT PATIENT WAS 378 00:13:25,480 --> 00:13:28,760 ALREADY AN ESTABLISHED CLINICAL 379 00:13:28,760 --> 00:13:29,880 CENTER PATIENT, A SLIGHT TWIST 380 00:13:29,880 --> 00:13:32,360 ON THIS STORY, NOT THE STORY I 381 00:13:32,360 --> 00:13:34,600 JUST PRESENTED BUT A 382 00:13:34,600 --> 00:13:35,720 HYPOTHETICAL, LET'S SAY A 383 00:13:35,720 --> 00:13:37,400 PATIENT HAD BEEN GOING ON A 384 00:13:37,400 --> 00:13:38,720 TREATMENT PROTOCOL THAT REQUIRED 385 00:13:38,720 --> 00:13:39,920 MULTIPLE PSYCHEETS AND 386 00:13:39,920 --> 00:13:41,560 TREATMENTS AT INTERVALS AND IN 387 00:13:41,560 --> 00:13:43,960 BETWEEN 1 OF THE INTERVALS AND 388 00:13:43,960 --> 00:13:45,840 THE NEXT, OUTSIDE OF THE NIHY 389 00:13:45,840 --> 00:13:47,120 HOO HAD BEEN ARRESTED AND HE 390 00:13:47,120 --> 00:13:49,280 LEARNED THAT HE WAS IN JAIL, IF 391 00:13:49,280 --> 00:13:51,240 HE WAS ABLE TO COME WOULD WE BE 392 00:13:51,240 --> 00:13:53,200 ALLOWED TO DO THAT. 393 00:13:53,200 --> 00:13:55,720 AND IF--DOES IT MATTER IF THE 394 00:13:55,720 --> 00:13:56,720 PROTOCOL IS LIMITED TO MEDICAL 395 00:13:56,720 --> 00:14:00,960 CARE OR IF THERE WAS 396 00:14:00,960 --> 00:14:02,040 EXPERIMENTAL THERAPY AND THOSE 397 00:14:02,040 --> 00:14:04,920 SORTS OF THINGS AND I LOOK FOR 398 00:14:04,920 --> 00:14:06,640 VERY FORWARD TO HEARING OUR 399 00:14:06,640 --> 00:14:12,640 PRESENTER DISCUSS THESE THINGS. 400 00:14:12,640 --> 00:14:14,520 >>THIS IS A HARD CASE SO IT'S 401 00:14:14,520 --> 00:14:15,920 GOING TO BE HARD TO TOUCH 402 00:14:15,920 --> 00:14:17,760 EVERYTHING SO I'M LOOKING 403 00:14:17,760 --> 00:14:19,560 FORWARD TO THE QUESTION SECTION. 404 00:14:19,560 --> 00:14:21,080 ALSO THERE ARE BROAD QUESTIONS 405 00:14:21,080 --> 00:14:24,400 BEING ASKED AND CASE SPECIFICS 406 00:14:24,400 --> 00:14:26,680 THAT ARE NOT ALWAYS DIRECTLY 407 00:14:26,680 --> 00:14:28,600 ALIGNED WITH THE QUESTIONS, 408 00:14:28,600 --> 00:14:31,200 BEFORE I START THOUGH, A COUPLE 409 00:14:31,200 --> 00:14:33,320 WORDS ABOUT ME, I'VE ACTUALLY 410 00:14:33,320 --> 00:14:34,480 GIVEN CLINICAL CENTER BIOETHICS 411 00:14:34,480 --> 00:14:36,120 GRAND ROUNDS BEFORE BUT I DOUBT 412 00:14:36,120 --> 00:14:37,440 MANY OF YOU WERE IN THE AUDIENCE 413 00:14:37,440 --> 00:14:40,640 BECAUSE IT WAS IN 2003 AND AT 414 00:14:40,640 --> 00:14:43,400 THAT TIME I WAS WEARING THE HAT 415 00:14:43,400 --> 00:14:44,920 OF CLINICAL CENTER CIO AND WE 416 00:14:44,920 --> 00:14:49,240 HAD JUST PUT IN THE CRIS SYSTEM 417 00:14:49,240 --> 00:14:51,200 AND THE TITLE WAS WHO OWNS THE 418 00:14:51,200 --> 00:14:51,960 DATA? 419 00:14:51,960 --> 00:14:54,280 AND I GAVE ANOTHER TALK THAT 420 00:14:54,280 --> 00:14:58,840 YEAR TALKING ABOUT INFORMATION 421 00:14:58,840 --> 00:14:59,640 FOR CLINICAL RESEARCH. 422 00:14:59,640 --> 00:15:02,880 SO MY CAREER HAS SPANNED 423 00:15:02,880 --> 00:15:04,320 MULTIPLE DOMAINS, I USED TO 424 00:15:04,320 --> 00:15:06,960 THINK WE ARE QUITE DIFFERENT BUT 425 00:15:06,960 --> 00:15:07,920 I'M REALLYING NOW THAT THEY ALL 426 00:15:07,920 --> 00:15:09,760 SEEM LIKE DIFFERENT ASPECTS OF 427 00:15:09,760 --> 00:15:10,600 THE SAME THING. 428 00:15:10,600 --> 00:15:17,960 I'VE GONE FROM HEMEATOLOGY TO 429 00:15:17,960 --> 00:15:19,840 INFORMATICS IT TO BIOETHICS, AND 430 00:15:19,840 --> 00:15:22,400 PARTICULARLY ALL THESE THINGS 431 00:15:22,400 --> 00:15:23,680 CONVERGING NOW, NOT DIRECTLY TO 432 00:15:23,680 --> 00:15:26,040 THIS CASE BUT IN THINGS LIKE BIG 433 00:15:26,040 --> 00:15:28,800 DATA ASK LEARNING AND PRIVACY 434 00:15:28,800 --> 00:15:29,840 AND SO, IT'S ACTUALLY AN 435 00:15:29,840 --> 00:15:34,640 INTERESTING TIME TO BE BACK. 436 00:15:34,640 --> 00:15:36,880 I WILL ALWAYS NOTE THAT MY 437 00:15:36,880 --> 00:15:38,240 WORKING BIOETHICS AS IT IS COMES 438 00:15:38,240 --> 00:15:41,360 FROM THE IRB WORLD. 439 00:15:41,360 --> 00:15:43,200 SO, I APPROACH BIOETHICS AS A 440 00:15:43,200 --> 00:15:45,600 SET OF PRACTICAL PROBLEMS AND 441 00:15:45,600 --> 00:15:46,800 BIOETHICS PRINCIPLES AND 442 00:15:46,800 --> 00:15:49,520 REGULATIONS, FRAMEWORKS FOR HOW 443 00:15:49,520 --> 00:15:52,480 TO ANSWER THEM. 444 00:15:52,480 --> 00:15:56,600 I THINK BIOETHICS ITSELF RARELY 445 00:15:56,600 --> 00:15:57,480 GIVES ANSWERS. 446 00:15:57,480 --> 00:15:59,320 IT REALLY INSTEAD GIVES YOU A 447 00:15:59,320 --> 00:16:00,880 FRAMEWORK FOR HOW TO THINK ABOUT 448 00:16:00,880 --> 00:16:03,840 THINGS, AND YET, JUST AS IN THIS 449 00:16:03,840 --> 00:16:05,480 CASE, WHEN YOU'RE SITTING ON AN 450 00:16:05,480 --> 00:16:06,960 IRB OR TAKING CARE OF PATIENTS 451 00:16:06,960 --> 00:16:08,920 AT THE CLINICAL CENTER, YOU NEED 452 00:16:08,920 --> 00:16:17,200 TO ANSWER QUESTIONS IN THE 453 00:16:17,200 --> 00:16:18,280 MOMENT I'LL LASTLY NOTE BECAUSE 454 00:16:18,280 --> 00:16:19,360 THIS IS RELEVANT TO SOME OF THE 455 00:16:19,360 --> 00:16:21,040 THINGS I WILL TOUCH ON, I DON'T 456 00:16:21,040 --> 00:16:22,440 THINK IT'S UNIQUE TO ME. 457 00:16:22,440 --> 00:16:25,600 I HAVE A GENERAL PESSIMISM OF 458 00:16:25,600 --> 00:16:27,040 THE DIRECTION OF THINGS IN THE 459 00:16:27,040 --> 00:16:28,960 WORLD AT THIS MOMENT, BUT I 460 00:16:28,960 --> 00:16:31,200 THINK IT'S CRITICAL THAT THAT 461 00:16:31,200 --> 00:16:32,040 NOT LEAD TO REZONING 8 HOURS 462 00:16:32,040 --> 00:16:33,640 NATION OR THAT IT'S NOT WORTH 463 00:16:33,640 --> 00:16:35,240 CALLING OUT ETHICAL ISSUES. 464 00:16:35,240 --> 00:16:38,560 THERE WILL BE SEVERAL THINGS 465 00:16:38,560 --> 00:16:40,280 THAT I TOUCH ON THAT I FEEL ARE 466 00:16:40,280 --> 00:16:41,560 OUTSIDE OUR ABILITY TO CONTROL 467 00:16:41,560 --> 00:16:43,640 OR TO AFFECT BUT THAT DOESN'T 468 00:16:43,640 --> 00:16:48,720 MEAN THEY SHOULDN'T BE CALLED 469 00:16:48,720 --> 00:16:49,200 THAT. 470 00:16:49,200 --> 00:16:50,320 WITH THAT HAVING BEEN SAID, LET 471 00:16:50,320 --> 00:16:51,640 ME TURN TO MY SLIDES. 472 00:16:51,640 --> 00:16:54,040 I WILL NOTE I HAVE NO CONFLICT 473 00:16:54,040 --> 00:16:55,560 OF INTEREST FOR ANY OF THE 474 00:16:55,560 --> 00:17:05,120 TOPICS IN TODAY'S SESSION EMPLOY 475 00:17:05,120 --> 00:17:06,880 AND NOW I WILL JUMP INTO THE 476 00:17:06,880 --> 00:17:08,080 QUESTIONS, I WILL NOTE THAT THE 477 00:17:08,080 --> 00:17:10,760 QUESTIONS, SO I HAVE STRUCTURED 478 00:17:10,760 --> 00:17:11,560 MY DISCUSSION AROUND QUESTIONS 479 00:17:11,560 --> 00:17:16,880 THAT WERE ON A SLIGHTLY EARLIER 480 00:17:16,880 --> 00:17:18,480 VERSION OF DR. LANG'S SLIDES. 481 00:17:18,480 --> 00:17:20,120 SO THEY'RE NOT EXACTLY THE SAME 482 00:17:20,120 --> 00:17:23,080 WORDING BUT I THINK THEY CAPTURE 483 00:17:23,080 --> 00:17:23,840 THE SAME POINTS. 484 00:17:23,840 --> 00:17:25,720 SO THE FIRST QUESTION IS A BROAD 485 00:17:25,720 --> 00:17:27,080 1, HOW SHOULD CLINICAL CARE BE 486 00:17:27,080 --> 00:17:29,160 PROVIDED TO INDIVIDUALS WHO HAVE 487 00:17:29,160 --> 00:17:29,520 BEEN ARRESTED? 488 00:17:29,520 --> 00:17:34,040 AND I'LL NOTE RIGHT NOW, IT'S IN 489 00:17:34,040 --> 00:17:37,920 THE BACKGROUND OF ALL OF THIS, 490 00:17:37,920 --> 00:17:38,880 THEY'RE PRACTICAL AND ETHICAL 491 00:17:38,880 --> 00:17:40,040 ISSUES HERE AND I'M GOING TO 492 00:17:40,040 --> 00:17:42,200 TALK ABOUT THE ETHICAL ISSUES. 493 00:17:42,200 --> 00:17:44,160 THERE ARE CLEARLY PRACTICAL 494 00:17:44,160 --> 00:17:48,560 ISSUES AS TO HOW YOU DELIVER 495 00:17:48,560 --> 00:17:49,880 CARE AND HOW YOU DIRECT THE 496 00:17:49,880 --> 00:17:56,240 POLICE IN THE CONTEXT OF ARREST 497 00:17:56,240 --> 00:17:58,120 THAT HAVE TO BE CONSIDERED AND 498 00:17:58,120 --> 00:17:59,320 PERHAPS THE DOMINANT IMPACT ON 499 00:17:59,320 --> 00:18:00,480 WHAT HAPPENS BUT I'M GOING TO 500 00:18:00,480 --> 00:18:04,800 TRY TO ADDRESS THE UNDERLYING 501 00:18:04,800 --> 00:18:06,800 ISSUES. 502 00:18:06,800 --> 00:18:08,960 SO THE QUESTION IS: HOW SHOULD 503 00:18:08,960 --> 00:18:10,080 CLINICAL CARE BE PROVIDED TO 504 00:18:10,080 --> 00:18:12,280 INDIVIDUAL WHO IS HAVE BEEN 505 00:18:12,280 --> 00:18:12,880 ARRESTED? 506 00:18:12,880 --> 00:18:15,160 SO INDIVIDUALS IN CUSTODY 507 00:18:15,160 --> 00:18:18,480 WHETHER THEY'RE UNDER ARREST OR 508 00:18:18,480 --> 00:18:21,960 IN PRISON, THE ISSUE IS THEY 509 00:18:21,960 --> 00:18:24,280 HAVE THEIR FREEDOMS LIMITED AND 510 00:18:24,280 --> 00:18:26,320 THEY MUST PROVIDE ON US TO 511 00:18:26,320 --> 00:18:31,320 INCLUDE THEIR HEALTHCARE AND IN 512 00:18:31,320 --> 00:18:32,880 SOME SITUATIONS PROVIDE HEALTH 513 00:18:32,880 --> 00:18:33,720 GUIDANCE FOR THEM. 514 00:18:33,720 --> 00:18:35,240 THERE'S NOTHING IN THE CODE OR 515 00:18:35,240 --> 00:18:37,320 AMA ETHICS THAT SUPPORTS A 516 00:18:37,320 --> 00:18:38,600 PHYSICIAN'S DUTIES BASED ON THE 517 00:18:38,600 --> 00:18:45,280 FACT THAT AN INDIVIDUAL WHO IS 518 00:18:45,280 --> 00:18:46,240 SUFFERING NEEDS. 519 00:18:46,240 --> 00:18:47,200 SO THESE OBSERVATIONS SUGGEST TO 520 00:18:47,200 --> 00:18:48,920 ME THAT BOTH SOCIETY AND DOCTORS 521 00:18:48,920 --> 00:18:50,960 HAVE A DUTY TO PROVIDE 522 00:18:50,960 --> 00:18:52,320 CLINICALLY NEEDED CARE, THE 523 00:18:52,320 --> 00:18:56,120 QUESTION ASKS HOW SUCH CARE CAN 524 00:18:56,120 --> 00:18:57,280 BE PROVIDED AND I THINK 525 00:18:57,280 --> 00:18:59,440 ANSWERING THIS QUESTION FROM THE 526 00:18:59,440 --> 00:19:00,160 PERSPECTIVE OF THE CLINICAL 527 00:19:00,160 --> 00:19:01,560 CENTER REQUIRES US TO ASK 528 00:19:01,560 --> 00:19:03,200 WHETHER HE COULD HAVE RECEIVED 529 00:19:03,200 --> 00:19:05,760 APPROPRIATE CARE OUTSIDE OF THE 530 00:19:05,760 --> 00:19:06,640 CLINICAL CENTER. 531 00:19:06,640 --> 00:19:09,960 AFTERALL HE WAS ADMITTED TO 532 00:19:09,960 --> 00:19:11,000 ANOTHER HOSPITAL, DIAGNOSED AND 533 00:19:11,000 --> 00:19:12,320 LATER TRANSFERRED TO THE 534 00:19:12,320 --> 00:19:14,800 CLINICAL CENTER FOR TREATMENT 535 00:19:14,800 --> 00:19:15,960 AFTER HIS WORSENING MALIGNANCY 536 00:19:15,960 --> 00:19:16,320 WAS DIAGNOSED. 537 00:19:16,320 --> 00:19:18,440 IF SOCIETY AND PHYSICIANS HAVE A 538 00:19:18,440 --> 00:19:20,480 DUTY TO PROVIDE CARE, WHY DIDN'T 539 00:19:20,480 --> 00:19:22,520 HE RECEIVE CARE AT THE HOSPITAL 540 00:19:22,520 --> 00:19:24,160 WHERE HE WAS FIRST ADMITTED. 541 00:19:24,160 --> 00:19:26,080 HAD HE RECEIVED SUCH CARE, WE 542 00:19:26,080 --> 00:19:27,480 WOULDN'T BE TALKING ABOUT THIS 543 00:19:27,480 --> 00:19:31,200 TODAY, HE LIKELY WOULD NOT HAVE 544 00:19:31,200 --> 00:19:33,080 BEEN ARRESTED AND HIS PERCEPTION 545 00:19:33,080 --> 00:19:39,760 HE HAD BEEN TRAPPED BY HIS NIH 546 00:19:39,760 --> 00:19:41,040 DOCTORS WOULD BE MOOT. 547 00:19:41,040 --> 00:19:42,440 AND I THINK THIS IS 1 OF THOSE 548 00:19:42,440 --> 00:19:43,960 AREAS THAT WE WILL NOT CHANGE 549 00:19:43,960 --> 00:19:45,840 TODAY BUT IT FORCES US TO LOOK 550 00:19:45,840 --> 00:19:47,920 AT DEEP PROBLEMS WITH OUR 551 00:19:47,920 --> 00:19:48,320 HEALTHCARE SYSTEM. 552 00:19:48,320 --> 00:19:50,200 I SUSPECT THAT HIS TRANSFER WAS 553 00:19:50,200 --> 00:19:51,640 NOT TO PROVIDE CARE THAT HE 554 00:19:51,640 --> 00:19:57,240 COULD ONLY RECEIVE AT NIH. 555 00:19:57,240 --> 00:19:58,160 IN FABLGHT EXPLICITLY THE 556 00:19:58,160 --> 00:20:01,240 PROTOCOL HE WAS ON ONLY PROVIDED 557 00:20:01,240 --> 00:20:02,560 STANDARD CARE, CLEARLY INDICATED 558 00:20:02,560 --> 00:20:03,240 HE NEEDED TREATMENT. 559 00:20:03,240 --> 00:20:14,240 I THINK IT HAS TO DO WITH OUR 560 00:20:14,240 --> 00:20:15,400 SAFETY NET AND IF WE HAD A 561 00:20:15,400 --> 00:20:16,480 EQUITABLE HEALTHCARE RESEARCH, 562 00:20:16,480 --> 00:20:23,360 WE WOULDN'T BE DISCUSSING THIS 563 00:20:23,360 --> 00:20:23,760 CASE TODAY. 564 00:20:23,760 --> 00:20:30,240 SO THE NEXT QUESTION WAS BEING 565 00:20:30,240 --> 00:20:31,440 IN POLICE CUSTODY WHAT 566 00:20:31,440 --> 00:20:32,680 INFORMATION SHOULD BE PROVIDED? 567 00:20:32,680 --> 00:20:34,720 I DON'T KNOW IF THIS CAME UP IN 568 00:20:34,720 --> 00:20:36,160 THE CASE AT HAND AND MAYBE IT 569 00:20:36,160 --> 00:20:38,160 DID BUT IT'S NOT IN THE CASE 570 00:20:38,160 --> 00:20:41,040 DESCRIPTION AND I THINK MY 571 00:20:41,040 --> 00:20:43,600 EARLIER COMMENTS ABOUT OUR 572 00:20:43,600 --> 00:20:50,040 EARLIER OBLIGATION AS PHYSICIANS 573 00:20:50,040 --> 00:20:51,200 APPLY, THERE IS 1 AREA WHERE 574 00:20:51,200 --> 00:20:54,080 THIS HAS BEEN ADDRESSED IN 575 00:20:54,080 --> 00:20:56,040 THE--BY THE AMA CODE OF ETHICS 576 00:20:56,040 --> 00:21:00,480 WHICH IS COURT DIRECTED 577 00:21:00,480 --> 00:21:02,760 THERAPIES, COURT-DIRECTED 578 00:21:02,760 --> 00:21:04,040 INTERVENTIONS. 579 00:21:04,040 --> 00:21:05,560 AND I REPRODUCED WHAT 580 00:21:05,560 --> 00:21:10,320 THOSE--WHAT THE AMA CODE OF 581 00:21:10,320 --> 00:21:12,160 ETHICS ACTUALLY SAYS AND IT 582 00:21:12,160 --> 00:21:13,520 BASICALLY REITERATES THAT OUR 583 00:21:13,520 --> 00:21:16,320 DUTIES ARE TOO OUR PATIENTS AND 584 00:21:16,320 --> 00:21:18,160 NOT NECESSARILY TO A COURT 585 00:21:18,160 --> 00:21:19,920 SYSTEM WHICH MAY HAVE SOCIALLY 586 00:21:19,920 --> 00:21:21,000 IMPORTANT INTERESTS BUT THEY'RE 587 00:21:21,000 --> 00:21:23,360 NOT NECESSARILY THE SAME 588 00:21:23,360 --> 00:21:27,120 INTERESTS AS THE HEALTHCARE 589 00:21:27,120 --> 00:21:31,160 SYSTEM AND SO, YOU KNOW SO WE 590 00:21:31,160 --> 00:21:38,720 ONLY SHOULD PROVIDE THERAPY 591 00:21:38,720 --> 00:21:40,720 THAT'S EFFICACIOUS AND CAN'T BE 592 00:21:40,720 --> 00:21:45,880 CONTRUED AS PART OF AN 593 00:21:45,880 --> 00:21:46,360 INDIVIDUAL'S PUNISHMENT, 594 00:21:46,360 --> 00:21:47,600 TREATMENT BY WHAT WE DIAGNOSE AS 595 00:21:47,600 --> 00:21:50,080 PHYSICIANS AND NOT WHAT THE 596 00:21:50,080 --> 00:21:51,920 COURTS SAY, DECLINE TO PROVIDE 597 00:21:51,920 --> 00:21:57,040 TREATMENT THAT'S NOT 598 00:21:57,040 --> 00:21:58,160 SCIENTIFICALLY VALIDATED AND AS 599 00:21:58,160 --> 00:21:59,640 BESTED WE CAN GIIVE THE 600 00:21:59,640 --> 00:22:01,040 SITUATION, MAKE SURE THE 601 00:22:01,040 --> 00:22:04,720 INDIVIDUAL HAS GIIVE CONSENT. 602 00:22:04,720 --> 00:22:05,960 AND I THINK A LOT OF THESE 603 00:22:05,960 --> 00:22:08,080 THINGS IN THE INDIVIDUAL CASE 604 00:22:08,080 --> 00:22:15,920 WILL BE FACT DEPENDENT. 605 00:22:15,920 --> 00:22:18,080 I THINK THAT--I'M SORRY, I'M 606 00:22:18,080 --> 00:22:20,040 GETTING AHEAD OF MYSELF, I 607 00:22:20,040 --> 00:22:25,440 APOLOGIZE FOR THE DELAY. 608 00:22:25,440 --> 00:22:27,600 THERE ARE CIRCUMSTANCES THAT YOU 609 00:22:27,600 --> 00:22:30,040 HAVE TO MAKE RULES BEEN WHERE 610 00:22:30,040 --> 00:22:31,200 INDIVIDUALS INCARCERATION OR 611 00:22:31,200 --> 00:22:32,240 ARREST MAY AFFECT DECISION 612 00:22:32,240 --> 00:22:34,160 MAKING EITHER BY LIMITING IT OR 613 00:22:34,160 --> 00:22:36,400 MAKING SOME CHOICES MORE 614 00:22:36,400 --> 00:22:37,320 ATTRACTIVE THAN OTHERS. 615 00:22:37,320 --> 00:22:40,480 FOR EXAMPLE, IF AN INVASIVE 616 00:22:40,480 --> 00:22:43,480 PROCEDURE, MAY BE IN EQUIPOISE 617 00:22:43,480 --> 00:22:45,760 WITH A NONINVASIVE APPROACH, BUT 618 00:22:45,760 --> 00:22:47,200 THE INVASIVE PROCEDURE WOULD 619 00:22:47,200 --> 00:22:50,320 LEAD TO A DELAY AND 620 00:22:50,320 --> 00:22:51,000 INCARCERATION, YOU KNOW THOSE 621 00:22:51,000 --> 00:22:52,560 ARE THINGS THAT WE WOULD HAVE TO 622 00:22:52,560 --> 00:22:58,200 CONSIDER ON A CASE BY CASE BASIS 623 00:22:58,200 --> 00:23:00,920 OR IF THE THOUGHT OF 624 00:23:00,920 --> 00:23:02,720 INCARCERATION CHANGED SOMEONE'S 625 00:23:02,720 --> 00:23:04,600 MENTAL STATE SO THEY'RE 626 00:23:04,600 --> 00:23:06,240 SUICIDAL, WE WOULD REALLY HAVE 627 00:23:06,240 --> 00:23:07,280 TO-LIFE BUT IT'S IMPOSSIBLE TO 628 00:23:07,280 --> 00:23:14,040 MAKE RULES ABOUT THOSE THINGS. 629 00:23:14,040 --> 00:23:18,680 SO THE NEXT QUESTION, DOES BEING 630 00:23:18,680 --> 00:23:29,080 IN POLICE ON A RESEARCH 631 00:23:33,000 --> 00:23:33,200 PROTOCOL? 632 00:23:33,200 --> 00:23:34,080 WE HAVE TO LEAD WITH THE 633 00:23:34,080 --> 00:23:36,640 QUESTION, AS A PRACTICAL ISSUE, 634 00:23:36,640 --> 00:23:38,080 NOT AS A BIOETHICS DECISION, CAN 635 00:23:38,080 --> 00:23:39,840 WE MAKE THIS DECISION LATE, SO 636 00:23:39,840 --> 00:23:43,080 SOMEONE WITH ARREST IS KIND OF 637 00:23:43,080 --> 00:23:44,800 IN LIMBO, THEY HAVEN'T BEEN 638 00:23:44,800 --> 00:23:46,760 CONVICTED OF A CRIME, NOT IN 639 00:23:46,760 --> 00:23:48,480 PRISON BUT THEIR FREEDOMS ARE 640 00:23:48,480 --> 00:23:49,840 CONTRAINT STRAINED AND IT WILL 641 00:23:49,840 --> 00:23:52,760 RESOLVE 1 WAY OR THE OTHER. 642 00:23:52,760 --> 00:23:53,720 OBVIOUSLY IF THEY'RE RELEASED 643 00:23:53,720 --> 00:23:56,880 THEN ALL THESE ISSUES ARE 644 00:23:56,880 --> 00:23:57,920 RESOLVED AND IF THEY'RE 645 00:23:57,920 --> 00:23:58,960 IMPRISONED THEN ANOTHER SET OF 646 00:23:58,960 --> 00:23:59,840 ISSUE SYSTEM CREATED BUT AT 647 00:23:59,840 --> 00:24:05,600 LEAST YOU SORT OF KNOW THE 648 00:24:05,600 --> 00:24:06,200 CONTEXT. 649 00:24:06,200 --> 00:24:11,600 SO IF YOU CAPTAIN DELAY IT THE 650 00:24:11,600 --> 00:24:14,120 ANSWER IS AGAIN, INDIVIDUALS 651 00:24:14,120 --> 00:24:17,080 RECEIVING ACCESS TO CARE, AND 652 00:24:17,080 --> 00:24:18,920 CARE OUTSIDE THE STUDY THEN IT'S 653 00:24:18,920 --> 00:24:20,080 OUR DUTY AS PHYSICIANS TO 654 00:24:20,080 --> 00:24:20,880 PROVIDE THAT CARE. 655 00:24:20,880 --> 00:24:22,720 IF AN INDIVIDUAL IS FREE TO 656 00:24:22,720 --> 00:24:25,720 CONSENT, AND REMOVING THEM FROM 657 00:24:25,720 --> 00:24:27,200 PARTICIPATION WOULD COMPROMISE 658 00:24:27,200 --> 00:24:28,160 THE SCIENTIFIC INTEGRITY OR 659 00:24:28,160 --> 00:24:29,360 VALUE OF THE STUDY AND I WILL 660 00:24:29,360 --> 00:24:31,160 COME BACK TO THAT ISSUE, THEN I 661 00:24:31,160 --> 00:24:34,080 THINK AS RESEARCHERS IN OUR DUTY 662 00:24:34,080 --> 00:24:35,080 AS RESEARCHERS IT'S ALL 663 00:24:35,080 --> 00:24:36,000 APPROPRIATE TO CONSIDER KEEPING 664 00:24:36,000 --> 00:24:39,320 THEM ON THE PROTOCOL. 665 00:24:39,320 --> 00:24:47,200 AND I THINK I PUT THIS--I PUT 666 00:24:47,200 --> 00:24:48,320 THIS BALANCE HERE BECAUSE FOR 667 00:24:48,320 --> 00:24:51,840 THE REASON THAT WE OFTEN LOOK AT 668 00:24:51,840 --> 00:24:52,800 THE RESEARCH REGULATIONS AND 669 00:24:52,800 --> 00:24:55,680 LOOK AT THE HARMS TO SOME THINGS 670 00:24:55,680 --> 00:24:57,360 OR THE BENEFITS THAT WE WILL 671 00:24:57,360 --> 00:24:58,320 RECEIVE DIRECTLY FROM 672 00:24:58,320 --> 00:25:00,080 PARTICIPATION AND WE PUT THAT ON 673 00:25:00,080 --> 00:25:02,680 1 SIDE OF THE SCALE AND IN THE 674 00:25:02,680 --> 00:25:04,360 CASE OF ARREST OR IMPRISONMENT, 675 00:25:04,360 --> 00:25:13,400 THE OTHER SIDE OF THE SCALE IS 676 00:25:13,400 --> 00:25:14,320 THE RESTRICTED AUTONOMY. 677 00:25:14,320 --> 00:25:15,560 WE ALL CONSIDER THE PERSONAL 678 00:25:15,560 --> 00:25:17,200 RISKS AND BENEFITS ON THE 679 00:25:17,200 --> 00:25:21,280 BALANCE SAID BUT WE WOULD ONLY 680 00:25:21,280 --> 00:25:28,320 ALLOW COMPROMISED AUTONOMY. 681 00:25:28,320 --> 00:25:35,960 IF IN THIS CASE--IF NOT 682 00:25:35,960 --> 00:25:38,720 ACCEPTING THAT WOULD LEAD TO 683 00:25:38,720 --> 00:25:39,800 HARMINGS OR DENIAL OF NEEDED 684 00:25:39,800 --> 00:25:41,160 CARE, I THINK A CASE CAN BE MADE 685 00:25:41,160 --> 00:25:43,400 AND I'M NOT SURE IT APPLIES IN 686 00:25:43,400 --> 00:25:45,600 THIS CASE, BUT IMAGINE A RARE 687 00:25:45,600 --> 00:25:49,760 DISEASE PROTOCOL WHERE THE DATA 688 00:25:49,760 --> 00:25:51,680 IS VERY VALUABLE, RESEARCH IS A 689 00:25:51,680 --> 00:25:54,960 SOCIAL ENTERPRISE AND A SOCIAL 690 00:25:54,960 --> 00:25:55,320 GOOD. 691 00:25:55,320 --> 00:25:58,800 IT'S NOT THAT IT SHOULD BE AN 692 00:25:58,800 --> 00:26:00,920 EASY DECISION, OR THAT IT SHOULD 693 00:26:00,920 --> 00:26:03,560 ALWAYS APPLY, BUT THE SCIENTIFIC 694 00:26:03,560 --> 00:26:14,120 MANDATE HAD WEIGHT ON THAT SCALE 695 00:26:21,120 --> 00:26:21,840 AS WELL. 696 00:26:21,840 --> 00:26:26,560 SO IS IT APPROPRIATE FOR 697 00:26:26,560 --> 00:26:28,480 PRISONERS TO APPLY TO A PERSON 698 00:26:28,480 --> 00:26:30,880 WHO IS UNDER ARREST? 699 00:26:30,880 --> 00:26:35,920 YES PROTECTIONS ARE CLEAR BUT TO 700 00:26:35,920 --> 00:26:46,040 AMRI TO INDIVIDUALS AWAITING 701 00:26:46,040 --> 00:26:49,120 AREIGNMENT, COURT TRIALS. 702 00:26:49,120 --> 00:26:51,160 REACTION TO EXPLOITATION, TO 703 00:26:51,160 --> 00:26:51,640 SYSTEMATIC EXPLOITATION. 704 00:26:51,640 --> 00:26:56,920 IT'S WORTH ASKING IF DENIAL IN 705 00:26:56,920 --> 00:26:57,840 ONGOING RESEARCH WITH DIRECT 706 00:26:57,840 --> 00:27:00,000 BENEFITS IN THE SETTING OF 707 00:27:00,000 --> 00:27:01,840 ONGOING CONSENT IS REALLY 708 00:27:01,840 --> 00:27:04,800 CONSISTENT WITH THE INTENT OF 709 00:27:04,800 --> 00:27:05,640 THE REGULATIONS. 710 00:27:05,640 --> 00:27:07,760 IS IT PROTECTION IN THAT CASE OR 711 00:27:07,760 --> 00:27:09,560 IS IT A LIMITATION OF ACCESS? 712 00:27:09,560 --> 00:27:12,360 AND THIS QUESTION IS BEING ASKED 713 00:27:12,360 --> 00:27:14,600 ABOUT THE REGULATIONS AND THE 714 00:27:14,600 --> 00:27:18,160 CONTEXT OF OTHER VULNERABLE 715 00:27:18,160 --> 00:27:18,440 POPULATIONS. 716 00:27:18,440 --> 00:27:21,440 THE QUESTION IS, IS THE WORDING 717 00:27:21,440 --> 00:27:23,120 AND CURRENT INTERPRETATIONS OF 718 00:27:23,120 --> 00:27:25,720 THE REGULATIONS HAS IT TO DATE 719 00:27:25,720 --> 00:27:28,240 LED TO INHERENT INIQUITIES AND 720 00:27:28,240 --> 00:27:32,120 INJUSTICES IN THE SOCIAL PROJECT 721 00:27:32,120 --> 00:27:32,440 OF RESEARCH? 722 00:27:32,440 --> 00:27:34,400 AS AN ASIDE, THERE'S PLENTIFUL 723 00:27:34,400 --> 00:27:36,320 EVIDENCE THAT BLACK PEOPLE ARE 724 00:27:36,320 --> 00:27:38,520 PLACED IN POLICE CUSTODY MUCH 725 00:27:38,520 --> 00:27:41,680 MORE FREQUENTLY THAN WHITE 726 00:27:41,680 --> 00:27:44,560 PEOPLE IS A STRICT READING OF 727 00:27:44,560 --> 00:27:47,000 THE REGULATORY LANGUAGE, DOES 728 00:27:47,000 --> 00:27:49,320 THAT LEAD TO EQUITIES AND ACCESS 729 00:27:49,320 --> 00:27:53,600 TO THESE, OR TO THE BENEFITS OF 730 00:27:53,600 --> 00:27:56,360 RESEARCHY AND I THINK THIS IS A 731 00:27:56,360 --> 00:27:58,920 TIME WHEN WE'RE REEXAMINING THAT 732 00:27:58,920 --> 00:28:02,920 IN MANY CONTEXTS. 733 00:28:02,920 --> 00:28:04,680 LASTLY AND WHILE THE REGULATIONS 734 00:28:04,680 --> 00:28:06,520 APPLY, THEY WERE WRITTEN TO 735 00:28:06,520 --> 00:28:08,240 ADDRESS PLANNED RESEARCH ON 736 00:28:08,240 --> 00:28:10,640 PRISONERS AS A POPULATION AND 737 00:28:10,640 --> 00:28:12,720 DON'T REALLY ADEQUATELY ADDRESS 738 00:28:12,720 --> 00:28:13,880 EITHER, 1 THE RIGHT APPROACH IN 739 00:28:13,880 --> 00:28:15,880 THE CASE WHERE AN INDIVIDUAL'S 740 00:28:15,880 --> 00:28:20,320 INCARCERATED DURING A RESEARCH 741 00:28:20,320 --> 00:28:21,600 PROTOCOL OR 2 THE RIGHT APPROACH 742 00:28:21,600 --> 00:28:23,200 TO INDIVIDUALS WHO ARE IN THIS 743 00:28:23,200 --> 00:28:25,320 LIMBO BETWEEN ARREST AND 744 00:28:25,320 --> 00:28:25,800 CONVICTION. 745 00:28:25,800 --> 00:28:27,920 IT'S MEANT TO COVER THEM SO THEY 746 00:28:27,920 --> 00:28:29,120 RECEIVE PROTECTIONS BUT IT 747 00:28:29,120 --> 00:28:30,040 DOESN'T PROICIDE US MUCH 748 00:28:30,040 --> 00:28:32,920 GUIDANCE AS TO WHAT TO DO IN 749 00:28:32,920 --> 00:28:35,600 THESE SITUATIONS. 750 00:28:35,600 --> 00:28:36,800 DOES IT MATTER 751 00:28:36,800 --> 00:28:41,000 WHETHER THE PROTOCOL IS LIMITED 752 00:28:41,000 --> 00:28:42,160 PROVIDING STANDARD MEDICAL CARE? 753 00:28:42,160 --> 00:28:45,040 >>SO FIRST OF ALL JUST 754 00:28:45,040 --> 00:28:46,000 CLARIFICATIONS HERE THAT 755 00:28:46,000 --> 00:28:48,800 PROTOCOL IS DOING MUCH MORE THAN 756 00:28:48,800 --> 00:28:50,120 PROVIDING STAN ARD MEDICAL CARE, 757 00:28:50,120 --> 00:28:52,040 IT'S CLICKING DATA AND 758 00:28:52,040 --> 00:28:54,680 BIOSPECIMENS, IT'S PROVIDING 759 00:28:54,680 --> 00:28:56,640 TRAINING, SO, I THINK WE NEED TO 760 00:28:56,640 --> 00:28:58,640 BE PRECISE IN OUR LANGUAGE. 761 00:28:58,640 --> 00:29:00,200 IT'S REALLY THE CARE PROVIDED BY 762 00:29:00,200 --> 00:29:02,200 THE PROTOCOL IS LIMITED TO 763 00:29:02,200 --> 00:29:03,200 STANDARD MEDICAL CARE BUT WE 764 00:29:03,200 --> 00:29:05,760 HAVE TO ACKNOWLEDGE THE PROTOCOL 765 00:29:05,760 --> 00:29:08,120 HAS VALUE BEYOND THAT. 766 00:29:08,120 --> 00:29:09,800 IF NOT, YOU KNOW THE CLINICAL 767 00:29:09,800 --> 00:29:12,080 CENTER WOULD NOT BE ALLOWED, THE 768 00:29:12,080 --> 00:29:13,640 CLINICAL CENTER CAN'T SIMPLY BE 769 00:29:13,640 --> 00:29:15,480 A PROVIDER OF HEALTHCARE. 770 00:29:15,480 --> 00:29:17,200 THAT BEING SAID, YOU KNOW THERE 771 00:29:17,200 --> 00:29:21,360 ARE JUST 2 SEPARATE AND LEGALLY 772 00:29:21,360 --> 00:29:23,040 ORTHOGONAL SETS OF CONCERNS HERE 773 00:29:23,040 --> 00:29:26,360 AND THERE ARE 2 SOCIAL PROJECTS. 774 00:29:26,360 --> 00:29:27,880 THERE'S THE PROJECT THAT 775 00:29:27,880 --> 00:29:29,080 FEDERALLY FUNDED SCIENCE FOR THE 776 00:29:29,080 --> 00:29:30,720 GOOD, THAT'S WHAT NIH IS ABOUT, 777 00:29:30,720 --> 00:29:32,440 AND THERE'S THE PROJECT OF 778 00:29:32,440 --> 00:29:36,800 CRIMINAL JUSTICE AND THE 779 00:29:36,800 --> 00:29:39,040 CRIMINAL JUSTICE SYSTEM WHICH 780 00:29:39,040 --> 00:29:40,320 SERVES AN ENTIRELY DIFFERENT 781 00:29:40,320 --> 00:29:41,560 SOCIAL JUSTICE PURPOSE. 782 00:29:41,560 --> 00:29:43,440 MOST OF THE TIME THOSE ARE 783 00:29:43,440 --> 00:29:45,440 SEPARATE WHICH IS WHY WE HAVE TO 784 00:29:45,440 --> 00:29:47,280 TALK ABOUT CASES LIKE THIS AND 785 00:29:47,280 --> 00:29:48,960 WHERE WE ANTICIPATE THEIR 786 00:29:48,960 --> 00:29:50,520 INTERSECTION AND REGULATIONS IN 787 00:29:50,520 --> 00:29:52,400 SUBPART C ARE SUPPOSED TO GUIDE 788 00:29:52,400 --> 00:29:56,800 US IN HOW TO BALANCE THESE 2 789 00:29:56,800 --> 00:29:57,920 INDIVIDUALLY MERITORIOUS 790 00:29:57,920 --> 00:30:03,160 PROJECTS. 791 00:30:03,160 --> 00:30:04,160 THAT PROVIDES THE CONTEXT. 792 00:30:04,160 --> 00:30:07,240 THE OTHER THING THAT I THINK IS 793 00:30:07,240 --> 00:30:10,400 VERY RELEVANT IS THIS WHOLE 794 00:30:10,400 --> 00:30:12,200 QUESTION, ONCE WE REMEMBER THAT 795 00:30:12,200 --> 00:30:13,720 THE PROTOCOL IS DOING MUCH MORE 796 00:30:13,720 --> 00:30:14,600 THAN PROVIDING CARE, IT'S 797 00:30:14,600 --> 00:30:16,680 COLLECTING DATA AND CONTRIBUTING 798 00:30:16,680 --> 00:30:18,640 TO SCIENTIFIC KNOWLEDGE AND 799 00:30:18,640 --> 00:30:22,480 ADVANCING THE PUBLIC GOOD IN 800 00:30:22,480 --> 00:30:22,880 THAT WAY. 801 00:30:22,880 --> 00:30:26,280 WE CAN LEAVE BEHIND FOR A MOMENT 802 00:30:26,280 --> 00:30:31,520 THIS IDEA THAT'S PERVASIVE THAT 803 00:30:31,520 --> 00:30:33,360 THE ONLY THING A PROTOCOL IS 804 00:30:33,360 --> 00:30:34,240 DOING OR COLLECTING FROM A 805 00:30:34,240 --> 00:30:39,960 PERSON IS SORT OF THESE 806 00:30:39,960 --> 00:30:40,280 INTERVENTIONS. 807 00:30:40,280 --> 00:30:41,240 YOU KNOW WE'RE FACING A TIME 808 00:30:41,240 --> 00:30:43,400 WHEN THE VALUE OF DATA IS BEING 809 00:30:43,400 --> 00:30:44,400 MADE VERY EXPLICIT. 810 00:30:44,400 --> 00:30:45,640 IN OUR COMMERCIAL SECTOR IT'S 811 00:30:45,640 --> 00:30:49,560 QUITE CLEAR THE DATA IS VERY 812 00:30:49,560 --> 00:30:49,880 HIGHLY VALUED. 813 00:30:49,880 --> 00:30:51,800 THAT'S SOMETHING THAT RESEARCH 814 00:30:51,800 --> 00:30:56,680 PARTICIPANTS ARE GIVING US FROM 815 00:30:56,680 --> 00:30:58,680 THEIR PARTICIPATION. 816 00:30:58,680 --> 00:31:00,680 AND AGAIN, IF WE STOP--AND DATA 817 00:31:00,680 --> 00:31:02,080 COLLECTION CAN ALSO HAVE HARMS. 818 00:31:02,080 --> 00:31:03,400 AND IF YOU'RE UNFAMILIAR WITH 819 00:31:03,400 --> 00:31:04,520 THAT, ALTHOUGH I THINK EVERYBODY 820 00:31:04,520 --> 00:31:07,080 IS NOW, I WOULD RECOMMEND THE 821 00:31:07,080 --> 00:31:10,960 FEDERAL TRADE COMMISSION JUST 822 00:31:10,960 --> 00:31:13,200 RELEASED AN AMPRN AN 823 00:31:13,200 --> 00:31:15,160 ANNOUNCEMENT OF POTENTERAL 824 00:31:15,160 --> 00:31:16,800 RESPECTIVE RULE MAKING ABOUT 825 00:31:16,800 --> 00:31:18,320 PRIVACY PROTECTIONS IN BIG DATA 826 00:31:18,320 --> 00:31:21,400 IF YOU WILL, UBIQUITOUS DATA 827 00:31:21,400 --> 00:31:22,360 COLLECTION WHICH DISCUSSES A LOT 828 00:31:22,360 --> 00:31:23,600 OF HARMS THAT COME FROM THIS. 829 00:31:23,600 --> 00:31:24,800 SO I THINK WE HAVE TO GET AWAY 830 00:31:24,800 --> 00:31:26,080 FROM THE IDEA THAT THE ONLY 831 00:31:26,080 --> 00:31:27,400 THINGS WE CONSIDER IN CASES LIKE 832 00:31:27,400 --> 00:31:29,720 THIS ARE THE DIRECT BENEFIT OR 833 00:31:29,720 --> 00:31:30,680 RISK THAT SOMEONE'S UNDERTAKING 834 00:31:30,680 --> 00:31:33,000 AND THAT TAKES US BACK TO THIS 835 00:31:33,000 --> 00:31:38,320 BALANCE WE HAVE TO FIND IN 836 00:31:38,320 --> 00:31:41,200 ANSWERING THE QUESTION HOW DO WE 837 00:31:41,200 --> 00:31:41,840 BALANCE, CONTINUED PARTICIPATION 838 00:31:41,840 --> 00:31:45,280 IF IT COMES IN THE FACE OF 839 00:31:45,280 --> 00:31:50,400 RESTRICTED AUTONOMY. 840 00:31:50,400 --> 00:31:51,880 SO I DON'T THINK THAT IT WILL 841 00:31:51,880 --> 00:31:53,200 MATTER IN THAT BALANCE WHETHER 842 00:31:53,200 --> 00:31:55,200 THE PROTOCOL IS LIMITED TO 843 00:31:55,200 --> 00:31:56,000 PROVIDING MEDICAL CARE BUT WE 844 00:31:56,000 --> 00:31:58,640 STILL HAVE TO CONSIDER THAT 845 00:31:58,640 --> 00:31:58,840 BALANCE. 846 00:31:58,840 --> 00:32:06,400 THERE ISN'T 1 ANSWER FOR ALL 847 00:32:06,400 --> 00:32:07,120 CIRCUMSTANCES. 848 00:32:07,120 --> 00:32:08,920 NOW THERE WERE 2 OTHER THINGS 849 00:32:08,920 --> 00:32:14,440 THAT THIS ISSUE, THIS CASE 850 00:32:14,440 --> 00:32:15,200 RAISED FOR ME. 851 00:32:15,200 --> 00:32:16,800 THAT WEREN'T IN THE QUESTIONS 852 00:32:16,800 --> 00:32:18,800 BUT I THINK BEARS MENTIONING, 1 853 00:32:18,800 --> 00:32:21,800 IS THE OBLIGATION OF RESEARCH 854 00:32:21,800 --> 00:32:22,120 PARTICIPANTS. 855 00:32:22,120 --> 00:32:26,440 AT LEAST 1 CHARGE AGAINST DL WAS 856 00:32:26,440 --> 00:32:28,080 RELATED TO ALLEGED THEFT AT NIH 857 00:32:28,080 --> 00:32:29,520 AND WHILE I HAVEN'T READ THE 858 00:32:29,520 --> 00:32:31,280 PROTOCOL, MOST PROT COLS ALLOW 859 00:32:31,280 --> 00:32:33,040 THE PRINCIPAL INVESTIGATOR TO 860 00:32:33,040 --> 00:32:33,680 TERMINATE A SUBJECT'S 861 00:32:33,680 --> 00:32:36,840 PARTICIPATION FOR A VARIETY OF 862 00:32:36,840 --> 00:32:37,760 REASONS AND IT'S CERTAINLY 863 00:32:37,760 --> 00:32:40,040 POSSIBLE HAD THE PI KNOWN OF THE 864 00:32:40,040 --> 00:32:41,480 THEFT, THE DL WOULD HAVE BEEN 865 00:32:41,480 --> 00:32:44,120 DROPPED FROM THE PROTOCOL BEFORE 866 00:32:44,120 --> 00:32:45,960 THESE EVENTS OCCURRED AND WHILE 867 00:32:45,960 --> 00:32:49,560 WE OFTEN TALK OF WHAT WE AS 868 00:32:49,560 --> 00:32:50,960 RESEARCHERS OWE OUR RESEARCH 869 00:32:50,960 --> 00:32:52,760 SUBJECTS, THERE ARE OBLIGATIONS 870 00:32:52,760 --> 00:32:55,400 SUBJECTS TAKE ON AND NOT 871 00:32:55,400 --> 00:32:56,520 FULFILLING THOSE OBLIGATIONS CAN 872 00:32:56,520 --> 00:32:57,720 HAVE CONSEQUENCES FOR THE 873 00:32:57,720 --> 00:32:58,400 PRACTICAL CONDUCT OF THE 874 00:32:58,400 --> 00:33:00,240 RESEARCH AND FOR THE INTEGRITY 875 00:33:00,240 --> 00:33:05,240 OF THE SCIENCE THAT RESULTS AND 876 00:33:05,240 --> 00:33:07,000 THE VALUE OF THAT SIZE. 877 00:33:07,000 --> 00:33:10,240 THE OTHER CONCERN IS THE ROLE OF 878 00:33:10,240 --> 00:33:10,880 THE NIH POLICE. 879 00:33:10,880 --> 00:33:14,000 YOU KNOW I WORKED AT NIEKS H FOR 880 00:33:14,000 --> 00:33:16,160 MORE THAN A DECADE BEFORE 9/11 881 00:33:16,160 --> 00:33:18,320 AND WE THOUGHT OF OURSELVES AS 882 00:33:18,320 --> 00:33:20,760 SCIENTISTS AND DOCTORS ALBEIT 883 00:33:20,760 --> 00:33:21,680 GOVERNMENT SCIENTISTS AND 884 00:33:21,680 --> 00:33:23,560 DOCTORS AND THE ROLE OF OUR 885 00:33:23,560 --> 00:33:25,480 INSTITUTION WAS TO CONDUCT 886 00:33:25,480 --> 00:33:26,800 RESEARCH TO IMPROVE THE HEALTH 887 00:33:26,800 --> 00:33:27,200 OF ALL. 888 00:33:27,200 --> 00:33:28,520 THE ROADS ON TO CAMPUS AND THE 889 00:33:28,520 --> 00:33:29,880 DOORS TO THE CLINICAL CENTER 890 00:33:29,880 --> 00:33:31,800 WERE OPEN, AND THE NIH POLICE 891 00:33:31,800 --> 00:33:33,640 WERE THERE TO PROTECT FEDERAL 892 00:33:33,640 --> 00:33:36,520 PROPERTY AND FEDERAL EMPLOYEES. 893 00:33:36,520 --> 00:33:41,200 THINGS HAVE CHANGED AND FOR VERY 894 00:33:41,200 --> 00:33:42,560 JUSTIFIABLE REASONS BUT FOR THE 895 00:33:42,560 --> 00:33:45,200 CLINICAL CENTER TO APPEAR TO 896 00:33:45,200 --> 00:33:47,480 PATIENTS AND VISITORS FIRST AS A 897 00:33:47,480 --> 00:33:49,320 FEDERAL FACILITY AND ONLY SECOND 898 00:33:49,320 --> 00:33:53,120 AS A RESEARCH HOSPITAL FRANKLY 899 00:33:53,120 --> 00:33:53,560 SADDENS ME. 900 00:33:53,560 --> 00:33:55,320 SO THIS IS MY LAST SLIDE AND 901 00:33:55,320 --> 00:33:59,360 JUST TO SUMMARIZE THE QUESTIONS, 902 00:33:59,360 --> 00:34:01,400 THE ISSUES, I THINK THERE'S THIS 903 00:34:01,400 --> 00:34:03,400 HUGE ISSUE AND THIS COMES UP ON 904 00:34:03,400 --> 00:34:04,880 THE IRB ALL THE TIME BECAUSE 905 00:34:04,880 --> 00:34:07,200 PEOPLE ENROLL IN PROTOCOLS, 906 00:34:07,200 --> 00:34:10,720 BECAUSE THEY CAN'T OFTEN GET 907 00:34:10,720 --> 00:34:12,240 ADEQUATE CARE ELSEWHERE, SO HOW 908 00:34:12,240 --> 00:34:16,280 DO YOU CONDUCT ETHICAL RESEARCH 909 00:34:16,280 --> 00:34:17,320 WHETHER IT INVOLVES STANDARD 910 00:34:17,320 --> 00:34:19,720 CARE OR NOT IN THE CONTEXT OF A 911 00:34:19,720 --> 00:34:22,440 HEALTHCARE DELIVERY SYSTEM THAT 912 00:34:22,440 --> 00:34:24,080 IS INEQUITABLE AND UNJUST? 913 00:34:24,080 --> 00:34:26,720 I THINK THE SECOND ISSUE IS 914 00:34:26,720 --> 00:34:28,960 REGULATIONS THAT WERE WRITTEN 915 00:34:28,960 --> 00:34:32,800 SOME YEARS AGO NOW TO 916 00:34:32,800 --> 00:34:33,640 APPROPRIATELY ADDRESS ELGTICAL 917 00:34:33,640 --> 00:34:35,400 TRESPASSES AND WHICH CAN NOW, 918 00:34:35,400 --> 00:34:38,440 YOU KNOW--BUT ARE FAIRLY NARROW. 919 00:34:38,440 --> 00:34:40,240 AND SO, DON'T REALLY APPLY WELL 920 00:34:40,240 --> 00:34:42,320 TO SOME OF THE THINGS WE'RE 921 00:34:42,320 --> 00:34:44,760 SEEING TODAY AND IN THIS CASE, 922 00:34:44,760 --> 00:34:48,280 WE HAVE A SET OF REGULATIONS 923 00:34:48,280 --> 00:34:50,440 THAT MEANT TO PROTECT PRISONERS 924 00:34:50,440 --> 00:34:51,680 FROM EXPLOITATION BUT WE HAVE AN 925 00:34:51,680 --> 00:34:53,240 INDIVIDUAL WHO WILL SUFFER IF 926 00:34:53,240 --> 00:34:54,520 NOT CONTINUED ON THEIR RESEARCH 927 00:34:54,520 --> 00:34:55,320 PROTOCOL AND WE HAVE SCIENCE 928 00:34:55,320 --> 00:34:56,960 THAT WILL SUFFER AND WE HAVE TO 929 00:34:56,960 --> 00:34:59,120 ASK, IS THAT REALLY WHAT WAS 930 00:34:59,120 --> 00:35:04,240 BEHIND THE REGULATIONS OR DO WE 931 00:35:04,240 --> 00:35:04,760 NEED SOME ADDITIONAL 932 00:35:04,760 --> 00:35:05,440 INTERPRETATION. 933 00:35:05,440 --> 00:35:06,040 I THINK THE THIRD THING IS 934 00:35:06,040 --> 00:35:09,560 SCIENCE IS A PUBLIC GOOD. 935 00:35:09,560 --> 00:35:11,400 AGAIN, WE ALWAYS--THE RESEARCH 936 00:35:11,400 --> 00:35:14,440 REGULATIONS AND OUR ETHICAL 937 00:35:14,440 --> 00:35:16,400 FRAMEWORKS ARE FOCUSED ON HARMS 938 00:35:16,400 --> 00:35:17,240 TO THE PARTICIPANTS BECAUSE OF 939 00:35:17,240 --> 00:35:18,440 THE HISTORY OF THOSE REGULATIONS 940 00:35:18,440 --> 00:35:21,440 AND HOW THOSE ISSUES AROSE. 941 00:35:21,440 --> 00:35:23,040 BUT SCIENCE ITSELF, THAT THE 942 00:35:23,040 --> 00:35:24,000 JUSTIFICATION FOR FUNDING THE 943 00:35:24,000 --> 00:35:30,080 NIH AND FOR THE NIH'S MISSION IS 944 00:35:30,080 --> 00:35:31,360 THAT SCIENCE IS AN IMPORTANT 945 00:35:31,360 --> 00:35:33,160 PUBLIC GOOD AND I THINK THAT HAS 946 00:35:33,160 --> 00:35:35,240 TO BE PART OF THE BALANCE WHEN 947 00:35:35,240 --> 00:35:36,560 WE MAKE THESE DECISIONS. 948 00:35:36,560 --> 00:35:39,720 THE NEXT 1 IS SOMETHING THAT I 949 00:35:39,720 --> 00:35:41,320 THINK IS FAMILIAR TO PROBABLY 950 00:35:41,320 --> 00:35:43,800 EVERYBODY WHO'S LISTENING AND 951 00:35:43,800 --> 00:35:46,960 THAT IS THAT OUR ROLE, OUR ROLES 952 00:35:46,960 --> 00:35:49,480 ARE OFTEN AND OUR DUTIES, OUR 953 00:35:49,480 --> 00:35:50,880 ETHICAL DUTIES ARE OFTEN 954 00:35:50,880 --> 00:35:51,840 CONFLINTHED AND FINDING A 955 00:35:51,840 --> 00:35:55,280 BALANCE BETWEEN THEM IS NOT 956 00:35:55,280 --> 00:35:56,280 ALWAYS STRAIGHT FORWARD. 957 00:35:56,280 --> 00:35:59,120 IN CLINICAL RESEARCH, THERE'S 958 00:35:59,120 --> 00:36:03,360 ALWAYS A TENSION BETWEEN ACTING 959 00:36:03,360 --> 00:36:04,880 AS AN INVESTIGATOR AND ACTING AS 960 00:36:04,880 --> 00:36:05,120 A DOCTOR. 961 00:36:05,120 --> 00:36:07,000 AND I THINK THE CLINICAL CENTER, 962 00:36:07,000 --> 00:36:09,080 DOCTORS AND PROVIDERS AT THE 963 00:36:09,080 --> 00:36:10,320 CLINICAL CENTER HAVE AN 964 00:36:10,320 --> 00:36:13,200 ADDITIONAL FRAMEWORK, THAT OF 965 00:36:13,200 --> 00:36:15,040 THE FEDERAL EMPLOYEES WITH--WHO 966 00:36:15,040 --> 00:36:16,560 ARE ACCOUNTABLE TO TAXPAYERS AND 967 00:36:16,560 --> 00:36:20,840 SOCIETY IN THAT ROLE, THAT MAY 968 00:36:20,840 --> 00:36:21,720 ALSO BE INTENTIONED IN SOME 969 00:36:21,720 --> 00:36:25,040 CASES AND THE LAST THING IS, YOU 970 00:36:25,040 --> 00:36:27,080 KNOW JUST TO MY LAST POINT TO 971 00:36:27,080 --> 00:36:28,200 THE PREVIOUS SLIDE, DOES THE 972 00:36:28,200 --> 00:36:29,720 CLINICAL CENTER WANT TO BE SEEN 973 00:36:29,720 --> 00:36:31,280 AS A FEDERAL FACILITY THAT IS A 974 00:36:31,280 --> 00:36:32,400 RESEARCH HOSPITAL OR AS A 975 00:36:32,400 --> 00:36:34,960 RESEARCH HOSPITAL THAT HAPPENS 976 00:36:34,960 --> 00:36:36,520 TO BE A FEDERAL FACILITY AND I 977 00:36:36,520 --> 00:36:40,600 SUSPECT THAT MOST OF THE PEOPLE 978 00:36:40,600 --> 00:36:41,880 WHO ARE LISTENING WOULD, WELL, I 979 00:36:41,880 --> 00:36:43,640 HOPE WOULD LIKE TO SEE A ROLE AS 980 00:36:43,640 --> 00:36:45,160 THAT OF A RESEARCH HOSPITAL 981 00:36:45,160 --> 00:36:45,360 FIRST. 982 00:36:45,360 --> 00:36:49,400 I'M GOING TO TRY TO TURN ON MY 983 00:36:49,400 --> 00:36:59,880 CAMERA NOW, FOR THE QUESTIONS. 984 00:37:12,680 --> 00:37:14,440 >>THANK YOU THAT WAS GREAT. 985 00:37:14,440 --> 00:37:16,360 JUST A COUPLE, 2 QUICK REMINDERS 986 00:37:16,360 --> 00:37:18,200 BEFORE WE GET STARTED HERE. 987 00:37:18,200 --> 00:37:20,000 FIRST A REMINDER FOR PEOPLE WHO 988 00:37:20,000 --> 00:37:21,800 CHECKED IN LATE, THERE IS CME 989 00:37:21,800 --> 00:37:24,120 CREDIT FOR THIS SESSION THROUGH 990 00:37:24,120 --> 00:37:26,280 JOHNS HOPKINS TO GET THAT CME 991 00:37:26,280 --> 00:37:28,040 CREDIT YOU NEED TO TEXT THE 992 00:37:28,040 --> 00:37:30,160 FOLLOWING CODE TO THE HOPKINS 993 00:37:30,160 --> 00:37:31,880 CME NUMBER THAT'S ON THE INITIAL 994 00:37:31,880 --> 00:37:33,600 SLIDE AND THAT WILL COME UP 995 00:37:33,600 --> 00:37:35,080 AGAIN AT THE END OF THE SESSION, 996 00:37:35,080 --> 00:37:36,920 IF YOU DIDN'T GET TO SEE IT AND 997 00:37:36,920 --> 00:37:42,440 THAT CODE FOR TODAY'S SESSION IS 998 00:37:42,440 --> 00:37:44,000 44524. 999 00:37:44,000 --> 00:37:46,720 SO 44524. 1000 00:37:46,720 --> 00:37:48,120 THAT'S TO CLAIM CME CREDIT. 1001 00:37:48,120 --> 00:37:49,560 THE SECOND THING IS WE WELCOME 1002 00:37:49,560 --> 00:37:50,840 PEOPLE'S TIME FOR QUESTIONS, WE 1003 00:37:50,840 --> 00:37:52,160 HAVE TIME FOR QUESTION ANDS TO 1004 00:37:52,160 --> 00:37:55,080 ASK QUESTIONS YOU GO TO THE LIVE 1005 00:37:55,080 --> 00:37:57,200 FEEDBACK BUTTON AT THE BOTTOM OF 1006 00:37:57,200 --> 00:38:00,280 THE SCREEN ON THE NIH VIDEOCAST 1007 00:38:00,280 --> 00:38:01,680 WEBSITE, AND THOSE QUESTIONS 1008 00:38:01,680 --> 00:38:04,880 WILL BE DIRECTED TO ME AND I'LL 1009 00:38:04,880 --> 00:38:06,840 ASK THEM OF STEPHEN AS WE HAVE 1010 00:38:06,840 --> 00:38:07,040 TIME. 1011 00:38:07,040 --> 00:38:08,080 SO IF PEOPLE HAVE QUESTIONS 1012 00:38:08,080 --> 00:38:10,160 PLEASE PUT THEM IN AND I'LL ASK 1013 00:38:10,160 --> 00:38:13,560 THEM AS WE GO. 1014 00:38:13,560 --> 00:38:17,400 SO I WANTED TO START JUST BY 1015 00:38:17,400 --> 00:38:19,360 MAKING SURE--I THINK THIS IS 1016 00:38:19,360 --> 00:38:23,280 RIGHT JUST TO CLARIFY AND 1017 00:38:23,280 --> 00:38:23,880 REINFORCE THIS. 1018 00:38:23,880 --> 00:38:25,240 IT SOUNDS LIKE YOUR VIEW AND 1019 00:38:25,240 --> 00:38:28,000 JUST BY THE REGULATION, SO 1020 00:38:28,000 --> 00:38:31,000 SOMEBODY WHO'S IN POLICE CUSTODY 1021 00:38:31,000 --> 00:38:33,240 IS COUNTED AS A PRISONER FOR THE 1022 00:38:33,240 --> 00:38:34,800 PURPOSE OF THE PRISONER 1023 00:38:34,800 --> 00:38:36,800 REGULATIONS AND MORE OVER THAT'S 1024 00:38:36,800 --> 00:38:39,760 TRUE EVEN IF THEY ENROLLED IN 1025 00:38:39,760 --> 00:38:42,040 THE STUDY AND BEGAN 1026 00:38:42,040 --> 00:38:43,480 PARTICIPATING IN THE STUDY 1027 00:38:43,480 --> 00:38:45,840 BEFORE THEY BECAME ARRESTED. 1028 00:38:45,840 --> 00:38:48,520 AND SO SOMEBODY WHO STARTS IN A 1029 00:38:48,520 --> 00:38:51,160 TRIAL, GIVES CONSENT WITHOUT ANY 1030 00:38:51,160 --> 00:38:52,760 CONCERNS ABOUT ARREST OR 1031 00:38:52,760 --> 00:38:53,880 COERCION IS PARTICIPATING IN THE 1032 00:38:53,880 --> 00:38:56,000 STUDY FOR A WHILE, THEN GETS 1033 00:38:56,000 --> 00:38:56,960 ARRESTED, THAT PERSON EVEN 1034 00:38:56,960 --> 00:38:58,600 THOUGH THEY'RE NOT IN PRISON 1035 00:38:58,600 --> 00:39:00,200 YET, THEY'RE ALREADY AT HOME, 1036 00:39:00,200 --> 00:39:02,280 THAT PERSON COUNTS AS A PRISONER 1037 00:39:02,280 --> 00:39:04,040 ACCORDING TO THE REGS AND 1038 00:39:04,040 --> 00:39:05,560 THEREFORE COULDN'T CONTINUE TO 1039 00:39:05,560 --> 00:39:06,520 PARTICIPATE WITHOUT THE IRB 1040 00:39:06,520 --> 00:39:09,880 GOING THROUGH ALL OF THE 1041 00:39:09,880 --> 00:39:11,760 PRISONER RANKS WITH RESPECT TO 1042 00:39:11,760 --> 00:39:13,040 THE PROTOCOLS, DOES THAT SOUND 1043 00:39:13,040 --> 00:39:13,320 RIGHT? 1044 00:39:13,320 --> 00:39:15,040 >>I THINK THAT IS RIGHT. 1045 00:39:15,040 --> 00:39:17,480 SO ON IRBs WE OFTEN SEE THIS, 1046 00:39:17,480 --> 00:39:20,480 PEOPLE END UP IN PRISON OR 1047 00:39:20,480 --> 00:39:22,000 ARRESTED, YOU KNOW IT HAPPENS 1048 00:39:22,000 --> 00:39:24,240 AND I THINK THAT'S A FREQUENT 1049 00:39:24,240 --> 00:39:26,360 THING AND IT OFTEN COMES BACK TO 1050 00:39:26,360 --> 00:39:28,840 AN IRB THAT DOESN'T HAVE A 1051 00:39:28,840 --> 00:39:31,040 PRISONER REPRESENTED AND THEN 1052 00:39:31,040 --> 00:39:33,560 USUALLY THE QUESTION IS, WILL 1053 00:39:33,560 --> 00:39:34,800 THIS CONTINUATION HARM THAT 1054 00:39:34,800 --> 00:39:35,240 INDIVIDUAL? 1055 00:39:35,240 --> 00:39:36,680 DO THEY NEED SOMETHING THAT THEY 1056 00:39:36,680 --> 00:39:38,800 CAN ONLY GET THROUGH THE 1057 00:39:38,800 --> 00:39:39,120 RESEARCH? 1058 00:39:39,120 --> 00:39:43,240 AND IF THEY DO, THE IRB REALLY 1059 00:39:43,240 --> 00:39:48,160 HAS TO SAY, YOU KNOW YOU 1060 00:39:48,160 --> 00:39:50,000 CAN'T--SO, I SUSPECT EVERY IRB 1061 00:39:50,000 --> 00:39:51,480 DOES THIS DIFFERENTLY BUT I 1062 00:39:51,480 --> 00:39:53,280 THINK IT WOULD BE ETHICALLY 1063 00:39:53,280 --> 00:39:55,280 INCORRECT OR WRONG TO DENY 1064 00:39:55,280 --> 00:39:57,920 SOMEONE ACCESS TO A PROTOCOL IN 1065 00:39:57,920 --> 00:39:59,240 WHICH THEY ALREADY STARTED IN 1066 00:39:59,240 --> 00:40:00,760 WHICH THEY GAVE CONSENT TO AND 1067 00:40:00,760 --> 00:40:03,960 WE WERE DENYING THEM WOULD HARM 1068 00:40:03,960 --> 00:40:05,480 THEM BECAUSE THE REGULATIONS SAY 1069 00:40:05,480 --> 00:40:08,360 YOU NEED A PRISONER 1070 00:40:08,360 --> 00:40:08,720 [INDISCERNIBLE]. 1071 00:40:08,720 --> 00:40:10,360 THERE ARE LOTS OF WAYS YOU COULD 1072 00:40:10,360 --> 00:40:11,600 APPROACH THAT, GET A PRISONER 1073 00:40:11,600 --> 00:40:13,240 REP AREY SENTED AS A CONSULTANT, 1074 00:40:13,240 --> 00:40:15,800 YOU COULD DO LOTS OF THINGS BUT 1075 00:40:15,800 --> 00:40:16,520 DENYING SOMEONE THAT ACCESS 1076 00:40:16,520 --> 00:40:18,040 BECAUSE OF THE LIMINGITTATIONS 1077 00:40:18,040 --> 00:40:21,040 OF YOUR IRB WOULD NOT BE PROPER. 1078 00:40:21,040 --> 00:40:23,880 THERE'S ANOTHER PIECE TO THAT, 1079 00:40:23,880 --> 00:40:26,720 WHICH WAS IN DR. LANG'S 1080 00:40:26,720 --> 00:40:27,800 OIGEINAL--WAS IN THE SLIDES AND 1081 00:40:27,800 --> 00:40:30,000 THAT I DIDN'T ANSWER WHICH IS 1082 00:40:30,000 --> 00:40:33,840 DOES IT MATTER IF THEY WERE ON 1083 00:40:33,840 --> 00:40:35,520 THE PROTOCOL BEFORE OR NOT AND I 1084 00:40:35,520 --> 00:40:37,240 THINK IT DOES MATTER. 1085 00:40:37,240 --> 00:40:39,120 SO THE REGULATIONS WERE REALLY 1086 00:40:39,120 --> 00:40:41,480 TO PROTECT PEOPLE FROM 1087 00:40:41,480 --> 00:40:42,920 PROSPECTIVE INVOLVEMENT IN 1088 00:40:42,920 --> 00:40:44,240 RESEARCH, PRISONERS AS A 1089 00:40:44,240 --> 00:40:44,840 POPULATION. 1090 00:40:44,840 --> 00:40:47,680 AND I THINK IF PEOPLE AREN'T--I 1091 00:40:47,680 --> 00:40:52,800 DON'T CPS AS RESEARCHERS WE CAN 1092 00:40:52,800 --> 00:40:54,760 SAY, SOMEONE SHOULD GET THIS 1093 00:40:54,760 --> 00:40:59,040 INTERVENTION THAT WE'RE TESTING 1094 00:40:59,040 --> 00:40:59,760 BECAUSE IT'S NECESSARY. 1095 00:40:59,760 --> 00:41:02,440 THERE ARE LOTS OF STUDIES THAT 1096 00:41:02,440 --> 00:41:04,480 GO ON, FOR INCURABLE CONDITIONS 1097 00:41:04,480 --> 00:41:05,760 OR CANCERS WHERE WE KNOW THE 1098 00:41:05,760 --> 00:41:07,360 OUTCOMES ARE POOR AND WE'RE 1099 00:41:07,360 --> 00:41:11,320 DOING RESEARCH ON ALTERNATIVES, 1100 00:41:11,320 --> 00:41:14,200 THAT'S TYPICALLY NOT SUFFICIENT 1101 00:41:14,200 --> 00:41:17,560 TO JUSTIFY ENROLLING PRISONERS 1102 00:41:17,560 --> 00:41:19,080 AS A POPULATION. 1103 00:41:19,080 --> 00:41:20,480 I THINK IT'S DIFFERENT. 1104 00:41:20,480 --> 00:41:21,600 IF SOMEONE'S ENROLLED ALREADY, 1105 00:41:21,600 --> 00:41:23,200 THEN IT COMES DOWN TO THEIR 1106 00:41:23,200 --> 00:41:25,760 SPECIFIC CASE AND AS I NOTED 1107 00:41:25,760 --> 00:41:27,280 THAT'S NOT SOMETHING THAT THE 1108 00:41:27,280 --> 00:41:27,880 REGULATIONS DREATIONZ 1109 00:41:27,880 --> 00:41:28,280 PARTICULARLY WELL. 1110 00:41:28,280 --> 00:41:29,600 THAT'S NOT WHAT THEY WERE 1111 00:41:29,600 --> 00:41:30,920 DESIGNED TO DO, THEY WERE 1112 00:41:30,920 --> 00:41:33,520 DESIGNED TO STOP PEOPLE FROM 1113 00:41:33,520 --> 00:41:41,000 BEING COERCED INTO PARTICIPATE 1114 00:41:41,000 --> 00:41:42,080 NOTHING RESEARCH. 1115 00:41:42,080 --> 00:41:43,040 >>GREAT. 1116 00:41:43,040 --> 00:41:44,600 I WAS STRUCK--I WASN'T AWARE OF 1117 00:41:44,600 --> 00:41:46,440 THE AMA GUIDANCE ON THIS BUT I 1118 00:41:46,440 --> 00:41:48,400 WAS STRUCK, I WILL TRY TO TIE 1119 00:41:48,400 --> 00:41:49,720 THESE 2 TOGETHER IN A SECOND, 1120 00:41:49,720 --> 00:41:51,280 BUT I WAS STRUCK BY WHAT IT SAID 1121 00:41:51,280 --> 00:41:53,840 IN PART WAS THAT WHILE 1122 00:41:53,840 --> 00:41:55,600 CLINICIANS, PHYSICIANS, I GUESS 1123 00:41:55,600 --> 00:41:57,920 HAVE AN OBLIGATION TO PROVIDE 1124 00:41:57,920 --> 00:42:01,000 CARE, EVEN TO PRISONERS, THAT 1125 00:42:01,000 --> 00:42:01,440 THEY SHOULD DECLINE. 1126 00:42:01,440 --> 00:42:03,280 I TRIED TO WRITE DOWN THE QUOTE 1127 00:42:03,280 --> 00:42:05,680 THEY SHOULD DECLINE TO PROVIDE 1128 00:42:05,680 --> 00:42:10,600 TREATMENT THAT HAS NOT BEEN 1129 00:42:10,600 --> 00:42:11,520 VALIDATED. 1130 00:42:11,520 --> 00:42:13,720 AND I WAS STRUCK BY THAT BECAUSE 1131 00:42:13,720 --> 00:42:14,520 THAT SOUNDS--MAYBE THAT'S JUST 1132 00:42:14,520 --> 00:42:16,760 WITHIN THE KIND OF SCOPE HERE, I 1133 00:42:16,760 --> 00:42:19,040 WAS WONDERING IF THAT RAISES 1134 00:42:19,040 --> 00:42:20,240 CONCERNS THEN ABOUT CLINICIANS 1135 00:42:20,240 --> 00:42:22,640 BEING INVOLVED IN RESEARCH 1136 00:42:22,640 --> 00:42:26,640 TRIALS WHERE YOU'RE TESTING SOME 1137 00:42:26,640 --> 00:42:28,000 EXPERIMENTAL INTERVENTION. 1138 00:42:28,000 --> 00:42:29,400 >>SO THAT'S NOT--TO MY READING 1139 00:42:29,400 --> 00:42:30,840 THAT'S NOT THE INTENDED OF THAT 1140 00:42:30,840 --> 00:42:34,320 OPINION, THAT OPINION IS TO 1141 00:42:34,320 --> 00:42:35,480 ADDRESS CIRCUMSTANCES WHERE THE 1142 00:42:35,480 --> 00:42:37,240 COURT DIRECTS THERAPY, THAT THE 1143 00:42:37,240 --> 00:42:37,920 INDIVIDUAL WOULDN'T NECESSARILY 1144 00:42:37,920 --> 00:42:39,040 WANT AND I THINK THAT GETS BACK 1145 00:42:39,040 --> 00:42:43,000 TO THE BALANCE OF THOSE 2 1146 00:42:43,000 --> 00:42:43,240 ISSUES. 1147 00:42:43,240 --> 00:42:44,920 COURTS MAY DO ALL SORTS OF 1148 00:42:44,920 --> 00:42:45,720 THINGS AND THERE'S LANGUAGE, I 1149 00:42:45,720 --> 00:42:49,880 WILL READ IT TO YOU FROM THE 1150 00:42:49,880 --> 00:42:51,600 THING ABOUT THE--YEAH, SO, IT'S 1151 00:42:51,600 --> 00:42:57,480 NOT EITHER A FORM OF PUNISHMENT 1152 00:42:57,480 --> 00:42:59,000 OR A MECHANISM OF SOCIAL 1153 00:42:59,000 --> 00:42:59,280 CONTROL. 1154 00:42:59,280 --> 00:43:02,720 SO WE AS DOCTORS SHOULD ONLY BE 1155 00:43:02,720 --> 00:43:04,120 APPLYING MEDICAL THINGS AND WE 1156 00:43:04,120 --> 00:43:08,840 SHOULDN'T BE USING AGENTS TO THE 1157 00:43:08,840 --> 00:43:09,480 CRIMINAL JUSTICE SYSTEM. 1158 00:43:09,480 --> 00:43:13,200 AND THERE'S A BODY OF LEGAL 1159 00:43:13,200 --> 00:43:16,720 PRECEDENT UP TO THE SUPREME 1160 00:43:16,720 --> 00:43:20,160 COURT WHICH LOOKS AT WHETHER 1161 00:43:20,160 --> 00:43:22,640 DENIAL OF HEALTHCARE AND THIS IS 1162 00:43:22,640 --> 00:43:25,640 NOT RESEARCH, BUT DENIAL OF 1163 00:43:25,640 --> 00:43:26,960 HEALTHCARE ACTUALLY IS 1164 00:43:26,960 --> 00:43:28,960 PROHIBITED BY THE EIGHTH 1165 00:43:28,960 --> 00:43:30,480 AMENDMENT AGAINST CRUEL AND 1166 00:43:30,480 --> 00:43:33,120 UNUSUAL PUNISHMENT AND SO IN 1167 00:43:33,120 --> 00:43:33,640 SOME CIRCUMSTANCES, IT 1168 00:43:33,640 --> 00:43:35,440 IS--THAT'S WHAT THE SUPREME 1169 00:43:35,440 --> 00:43:36,720 COURT CONCLUDED ALTHOUGH THERE'S 1170 00:43:36,720 --> 00:43:38,480 A FAIRLY HIGH BAR FOR SUGGESTING 1171 00:43:38,480 --> 00:43:41,880 THAT THAT'S ACTUALLY WHAT'S 1172 00:43:41,880 --> 00:43:44,040 GOING ON BUT, YEAH, SO, I THINK 1173 00:43:44,040 --> 00:43:46,240 THIS WAS--I THINK I ANSWERED THE 1174 00:43:46,240 --> 00:43:47,520 QUESTION, I HOPE. 1175 00:43:47,520 --> 00:43:49,760 BUT, YEAH. 1176 00:43:49,760 --> 00:43:52,280 THAT WASN'T THE INTENT OF THE 1177 00:43:52,280 --> 00:43:53,320 [INDISCERNIBLE]. 1178 00:43:53,320 --> 00:43:54,320 >>DO YOU THINK--I WANT TO TIE 1179 00:43:54,320 --> 00:43:56,320 THOSE TOGETHER JUST QUICKLY, I 1180 00:43:56,320 --> 00:44:01,000 REALLY LIKE YOUR CALL AT THE 1181 00:44:01,000 --> 00:44:02,000 BEGINNING OF THERE'S ISSUES 1182 00:44:02,000 --> 00:44:02,880 CHALLENGES AND MAYBE WE'RE NOT 1183 00:44:02,880 --> 00:44:05,880 GOING TO FIX ALL OF THEM OR MANY 1184 00:44:05,880 --> 00:44:08,200 OF THEM BUT WE SHOULD AT LEAST 1185 00:44:08,200 --> 00:44:09,840 DISCUSS THEM AND SEE WHAT WE CAN 1186 00:44:09,840 --> 00:44:11,640 DO AND I WAS WONDERING SURELY 1187 00:44:11,640 --> 00:44:13,120 WITH RESPECT TO THE CLINICAL 1188 00:44:13,120 --> 00:44:14,320 CARE SETTING AND MAYBE EVEN MORE 1189 00:44:14,320 --> 00:44:17,840 SO IN RESEARCH WHEN WE THINK 1190 00:44:17,840 --> 00:44:21,880 ABOUT THE PRISONER REGS, THEY'RE 1191 00:44:21,880 --> 00:44:23,800 FAIRLY RIGID AND THEY HAVE RULES 1192 00:44:23,800 --> 00:44:25,080 THAT AMRI TO EVERYBODY AND 1193 00:44:25,080 --> 00:44:26,000 OBVIOUSLY CAN YOU NEVER COME UP 1194 00:44:26,000 --> 00:44:27,560 WITH A RULE THAT WORKS IN EVERY 1195 00:44:27,560 --> 00:44:30,720 CASE, AND 1 OF THE THINGS I'VE 1196 00:44:30,720 --> 00:44:31,840 ALWAYS WONDERED IS, WELL IN SOME 1197 00:44:31,840 --> 00:44:33,520 CASES YOU DON'T HAVE ANY 1198 00:44:33,520 --> 00:44:34,000 ALTERNATIVES. 1199 00:44:34,000 --> 00:44:38,360 BUT IN THE RESEARCH STUDY WE DO 1200 00:44:38,360 --> 00:44:39,400 HAVE AN ALTERNATIVE, WE HAVE 1201 00:44:39,400 --> 00:44:41,960 THIS GROUP, YOU KNOW JUST ABOUT 1202 00:44:41,960 --> 00:44:43,920 EVERYBODY IN THE COUNTRY CALLED 1203 00:44:43,920 --> 00:44:44,960 IRBs AND THEIR CHALLENGE IS TO 1204 00:44:44,960 --> 00:44:47,640 MAKE SURE THAT THINGS ARE DONE 1205 00:44:47,640 --> 00:44:48,080 RIGHT. 1206 00:44:48,080 --> 00:44:51,240 AND SO I WAS WONDERING SHOULD 1207 00:44:51,240 --> 00:44:52,480 THERE BE--BECAUSE THERE'S THE 1208 00:44:52,480 --> 00:44:54,400 PIE IN THE SKY PART OF WHETHER 1209 00:44:54,400 --> 00:44:55,600 THIS WILL EVER HAPPEN BUT 1210 00:44:55,600 --> 00:44:57,360 WHETHER OR NOT YOU THINK IT 1211 00:44:57,360 --> 00:45:00,920 MAKES SENSE TO HAVE SOME KIND OF 1212 00:45:00,920 --> 00:45:01,960 EXCEPTIONS, QUALIFICATIONS, 1213 00:45:01,960 --> 00:45:03,040 FLEXIBILITY IN THE REGS THAT 1214 00:45:03,040 --> 00:45:09,400 SAYS BE, YOU KNOW IF A DULY 1215 00:45:09,400 --> 00:45:10,920 CONSITUTED IRB MAKES THE 1216 00:45:10,920 --> 00:45:12,000 JUDGMENT AND THE DETERMINE 1217 00:45:12,000 --> 00:45:14,440 NATION AND APPLIES IT AS THEY'RE 1218 00:45:14,440 --> 00:45:16,240 WRITTEN WILL BE SOMETHING LIKE A 1219 00:45:16,240 --> 00:45:17,480 SERIOUS MISTAKE IN A PARTICULAR 1220 00:45:17,480 --> 00:45:19,000 CASE, THEY ARE ALLOWED TO 1221 00:45:19,000 --> 00:45:21,920 EXERCISE SOME KIND OF EXPERIMENT 1222 00:45:21,920 --> 00:45:23,720 AND FLEXIBILITY, IS THAT A GREAT 1223 00:45:23,720 --> 00:45:23,960 IDEA? 1224 00:45:23,960 --> 00:45:25,160 NOW OF COURSE WE GO BACK TO THE 1225 00:45:25,160 --> 00:45:27,080 POINT OF THE CONFLICTS OF 1226 00:45:27,080 --> 00:45:28,000 INTEREST ON IRBs AND I DON'T 1227 00:45:28,000 --> 00:45:30,440 WANT TO TALK ABOUT, BUT I WAS 1228 00:45:30,440 --> 00:45:31,640 WOBDERRING WHAT YOU THOUGHT? 1229 00:45:31,640 --> 00:45:33,080 SHOULD YOU THINK THERE SHOULD BE 1230 00:45:33,080 --> 00:45:33,840 SOME KIND OF FLEXIBILITY LIKE 1231 00:45:33,840 --> 00:45:36,960 THAT IN THE SYSTEM OR IS THAT 1232 00:45:36,960 --> 00:45:37,560 NAIVE OR PROBLEMATIC? 1233 00:45:37,560 --> 00:45:38,800 >>SO I THINK THE WHYED IS A 1234 00:45:38,800 --> 00:45:39,040 GOOD 1. 1235 00:45:39,040 --> 00:45:42,280 WE NEED TO HAVE I CLINICAL 1236 00:45:42,280 --> 00:45:44,560 CENTER BIOETHICS GRAND ROUNDS ON 1237 00:45:44,560 --> 00:45:46,080 THE RIERKS SYSTEM. 1238 00:45:46,080 --> 00:45:46,520 BECAUSE--IRB SYSTEM. 1239 00:45:46,520 --> 00:45:47,600 BECAUSE I THINK THERE ARE LOTS 1240 00:45:47,600 --> 00:45:49,840 OF PROBLEMS WITH THE IRB SYSTEM 1241 00:45:49,840 --> 00:45:51,920 THAT MAKE THAT, I DON'T KNOW 1242 00:45:51,920 --> 00:45:52,960 HAVING 6 OR 10 OR 15 PEOPLE 1243 00:45:52,960 --> 00:45:56,400 AROUND A TABLE FROM A PARTICULAR 1244 00:45:56,400 --> 00:45:57,880 INSTITUTION OR PARTICULAR 1245 00:45:57,880 --> 00:46:00,040 COMPANY MAKING AN ETHICAL THING 1246 00:46:00,040 --> 00:46:04,640 THAT HAS IMPLICATIONS, WILL HAVE 1247 00:46:04,640 --> 00:46:06,760 IMPLICATIONS FOR OTHERS AS A 1248 00:46:06,760 --> 00:46:08,240 1-OFF DECISION IS NECESSARILY 1249 00:46:08,240 --> 00:46:08,800 APPROPRIATE. 1250 00:46:08,800 --> 00:46:15,040 IF WE HAD A SYSTEM WHERE IRBs 1251 00:46:15,040 --> 00:46:16,800 COULD CALL IT PRECEDENT ALTHOUGH 1252 00:46:16,800 --> 00:46:18,720 THAT'S A FRAUGHT WORD BECAUSE 1253 00:46:18,720 --> 00:46:19,600 PEOPLE SEE PRECEDENT AS BINDING 1254 00:46:19,600 --> 00:46:21,200 AND THERE ARE ALL SORTS OF 1255 00:46:21,200 --> 00:46:23,680 ISSUES BUT IF IRBs KDZ 1256 00:46:23,680 --> 00:46:24,320 COMMUNICATION RATIONALS AND 1257 00:46:24,320 --> 00:46:25,120 THOSE WERE PUBLIC AND THEY 1258 00:46:25,120 --> 00:46:27,680 SERVED AS A BUSINESS PROGRAMSIS 1259 00:46:27,680 --> 00:46:30,280 FOR SORT OF AN EMERGING AND 1260 00:46:30,280 --> 00:46:31,360 EVOLVING ETHICAL FRAMEWORK, I 1261 00:46:31,360 --> 00:46:33,240 THINK THERE SHOULD BE THAT 1262 00:46:33,240 --> 00:46:33,560 FLEXIBILITY. 1263 00:46:33,560 --> 00:46:36,440 I DON'T THINK THE CURRENT SYSTEM 1264 00:46:36,440 --> 00:46:38,240 PROVIDES IT I THINK THOSE 1265 00:46:38,240 --> 00:46:41,640 DECISIONS ARE MADE BEHIND CLOSED 1266 00:46:41,640 --> 00:46:42,760 DOORS, THEY NEVER FORM ANYTHING 1267 00:46:42,760 --> 00:46:43,560 ELSE, I DON'T THINK IT'S 1268 00:46:43,560 --> 00:46:45,320 APPROPRIATE AND I DO THINK THERE 1269 00:46:45,320 --> 00:46:47,480 ARE CONFLICTS OF INTEREST WHICH 1270 00:46:47,480 --> 00:46:48,920 WOULD RAISE QUESTIONS ABOUT THE 1271 00:46:48,920 --> 00:46:50,120 INTEGRITY OF THOSE DECISIONS. 1272 00:46:50,120 --> 00:46:52,240 SO I THINK THE IDEA OF ALLOWING 1273 00:46:52,240 --> 00:46:53,440 AND THE REGULATIONS ACTUALLY 1274 00:46:53,440 --> 00:46:54,640 DO,A LOW THIS, I MEAN I DON'T 1275 00:46:54,640 --> 00:46:56,080 KNOW THAT ANYONE TAKES ADVANTAGE 1276 00:46:56,080 --> 00:46:57,960 OF IT BUT THE REGULATIONS ALLOW 1277 00:46:57,960 --> 00:47:02,880 EXCEPTIONS TO BE MADE BY THE 1278 00:47:02,880 --> 00:47:03,840 SECRETARY. 1279 00:47:03,840 --> 00:47:06,200 OF HHS, SO IF THEIR PARTICULAR 1280 00:47:06,200 --> 00:47:07,120 CIRCUMSTANCES, YOU KNOW, WE'RE 1281 00:47:07,120 --> 00:47:14,760 ALL FAMILIAR WITH THOSE 1282 00:47:14,760 --> 00:47:16,360 PROVISIONS WITH SUBPART B IF YOU 1283 00:47:16,360 --> 00:47:18,960 CAN'T FIT IT INTO 1 OF THOSE 1284 00:47:18,960 --> 00:47:19,760 CATEGORIES, THEREYA A FORMAL 1285 00:47:19,760 --> 00:47:20,920 MECHANISM TO GO BEYOND THAT BUT 1286 00:47:20,920 --> 00:47:22,560 I THINK THAT'S A REASONABLE 1287 00:47:22,560 --> 00:47:26,680 MODEL IF THERE WAS A MECHANISM 1288 00:47:26,680 --> 00:47:28,480 TO APPEAL PARTICULAR PARTS OF 1289 00:47:28,480 --> 00:47:29,240 THE REGULATIONS, PARTICULARLY 1290 00:47:29,240 --> 00:47:36,160 NOW AS WE'RE BECOMING 1291 00:47:36,160 --> 00:47:37,920 INCREASINGLY AWARE OF THE 1292 00:47:37,920 --> 00:47:38,880 CONSEQUENCES OF STRICT 1293 00:47:38,880 --> 00:47:40,480 COMPLIANCE OF THE LETTER OF 1294 00:47:40,480 --> 00:47:43,720 REGULATIONS WHICH REALLY HAS LED 1295 00:47:43,720 --> 00:47:45,800 TO AN INEQUITABLE RESEARCH 1296 00:47:45,800 --> 00:47:46,760 SYSTEM AND INEQUITABLE 1297 00:47:46,760 --> 00:47:48,240 DISTRIBUTION OF BENEFITS NOT 1298 00:47:48,240 --> 00:47:50,760 JUST PROTECTION FROM 1299 00:47:50,760 --> 00:47:52,800 EXPLOITATION, BUT ACTUALLY A 1300 00:47:52,800 --> 00:47:54,600 SYSTEM THAT DOESN'T REPRESENT 1301 00:47:54,600 --> 00:47:55,840 THE SOCIETY THAT IT'S SUPPOSED 1302 00:47:55,840 --> 00:47:56,120 TO SERVE. 1303 00:47:56,120 --> 00:47:57,640 SO I THINK THERE ARE DEEPER 1304 00:47:57,640 --> 00:48:02,160 QUESTIONS AND A MECHANISM LIKE 1305 00:48:02,160 --> 00:48:03,920 THAT WOULD BE VERY WELCOME. 1306 00:48:03,920 --> 00:48:06,040 I DON'T THINK OUR CURRENT SYSTEM 1307 00:48:06,040 --> 00:48:08,480 OF IRBs PROVIDES THAT 1308 00:48:08,480 --> 00:48:08,880 ADEQUATELY. 1309 00:48:08,880 --> 00:48:12,080 I 1310 00:48:12,080 --> 00:48:12,320 -- 1311 00:48:12,320 --> 00:48:14,720 >>I SHOULD SAY YOU'RE NOT 1312 00:48:14,720 --> 00:48:16,520 BREAKING UP AT ALL NOW, SO KEEP 1313 00:48:16,520 --> 00:48:19,280 YOUR CAMERA ON FOR THE Q&A. 1314 00:48:19,280 --> 00:48:19,520 >>OKAY. 1315 00:48:19,520 --> 00:48:20,360 >>SO SOMEONE'S ASKING FOR 1316 00:48:20,360 --> 00:48:21,360 CLARICTION, DO YOU THINK THAT 1317 00:48:21,360 --> 00:48:22,760 THE 1 OF THE PRIMARY PROBLEMS 1318 00:48:22,760 --> 00:48:25,160 HERE IS JUST A BACKGROUND 1319 00:48:25,160 --> 00:48:27,400 CONTEXT CONCERNING THE U.S. 1320 00:48:27,400 --> 00:48:28,160 HEALTHCARE SYSTEM WHERE PEOPLE 1321 00:48:28,160 --> 00:48:33,320 CAN'T ALWAYS GET THE CARE THEY 1322 00:48:33,320 --> 00:48:36,480 NEED IN THE COMMUNITY AND 1323 00:48:36,480 --> 00:48:37,640 THEREFORE MAYBE LIKE FOR THIS 1324 00:48:37,640 --> 00:48:39,640 GUY, THE ONLY WAY TO GET IT IS 1325 00:48:39,640 --> 00:48:42,080 TO COME INTO A RESEARCH STUDY, 1326 00:48:42,080 --> 00:48:46,240 IS THAT RIGHT OR IF YOU HAD ANY 1327 00:48:46,240 --> 00:48:47,680 QUURGT FURTHER COMMENTS ON THAT? 1328 00:48:47,680 --> 00:48:49,120 >>I THINK THE CASE FROM 1329 00:48:49,120 --> 00:48:51,120 BEGINNING TO END LONG BEFORE THE 1330 00:48:51,120 --> 00:48:53,040 ARREST CAME UP IS AN EXAMPLE OF 1331 00:48:53,040 --> 00:48:53,320 THAT ISSUE. 1332 00:48:53,320 --> 00:48:57,640 I THINK IT'S VERY--IT'S NOT 1333 00:48:57,640 --> 00:48:59,960 ONLY--IT'S NOT ONLY ACCESS TO 1334 00:48:59,960 --> 00:49:01,840 BASIC CARE BUT I MEAN THERE'S 1335 00:49:01,840 --> 00:49:03,200 LITERATURE THAT SUGGESTS THAT 1336 00:49:03,200 --> 00:49:05,760 CARE, YOU GET CARE AT A RESEARCH 1337 00:49:05,760 --> 00:49:06,640 INSTITUTION IS OF A DIFFERENT 1338 00:49:06,640 --> 00:49:08,000 QUALITY THAN CARE YOU GET IN A 1339 00:49:08,000 --> 00:49:09,760 COMMUNITY HOSPITAL AND YOU KNOW 1340 00:49:09,760 --> 00:49:12,760 I THINK THESE ARE--THE 1341 00:49:12,760 --> 00:49:14,280 UNDERLYING--THERE ARE LOTS OF 1342 00:49:14,280 --> 00:49:16,000 CAUSES AND THEY'RE NOT EASY 1343 00:49:16,000 --> 00:49:18,480 FIXES BUT I THINK THEY ARE DEEP 1344 00:49:18,480 --> 00:49:21,280 PROBLEMS IN THEIR HEALTHCARE 1345 00:49:21,280 --> 00:49:22,560 SYSTEM, THAT CERTAINLY MAKE--I 1346 00:49:22,560 --> 00:49:25,120 SUSPECT FOR A PATIENT LIKE DL, 1347 00:49:25,120 --> 00:49:35,320 THAT'S WHY THEY'RE AT THE NIH. 1348 00:49:35,320 --> 00:49:40,720 >>SO 2 VERY PRACTICAL 1349 00:49:40,720 --> 00:49:41,040 QUESTIONS. 1350 00:49:41,040 --> 00:49:42,760 DOES HOW WE TREAT THIS GUY 1351 00:49:42,760 --> 00:49:44,880 DEPEND UPON THE NATURE OF 1352 00:49:44,880 --> 00:49:47,000 WARRANT WITH WHICH HE WAS 1353 00:49:47,000 --> 00:49:47,480 ARRESTED? 1354 00:49:47,480 --> 00:49:49,840 SO IT WAS CHILD PAYMENT AND SOME 1355 00:49:49,840 --> 00:49:50,120 THEFT? 1356 00:49:50,120 --> 00:49:53,120 IS THAT DIFFERENT THAN IF IT HAD 1357 00:49:53,120 --> 00:49:53,480 BEEN HOMICIDE? 1358 00:49:53,480 --> 00:49:56,320 EASY QUESTIONS HERE FOR YOU? 1359 00:49:56,320 --> 00:49:57,920 THE SECOND 1 IS JUST A PRACTICAL 1360 00:49:57,920 --> 00:50:00,280 QUESTION, IS THIS A GREAT IDEA 1361 00:50:00,280 --> 00:50:01,880 OR JUST GOING OVERBOARD? 1362 00:50:01,880 --> 00:50:04,480 SHOULD THERE BE SOME KIND OF 1363 00:50:04,480 --> 00:50:06,920 JUST SCREENING WARNING FOR 1364 00:50:06,920 --> 00:50:07,240 PEOPLE? 1365 00:50:07,240 --> 00:50:08,000 ONE THE OF THE THINGS THAT WILL 1366 00:50:08,000 --> 00:50:09,120 HAPPEN WHEN YOU COME HERE IS YOU 1367 00:50:09,120 --> 00:50:10,840 WILL HAVE TO GO THROUGH THIS 1368 00:50:10,840 --> 00:50:12,200 SCREENING, AS YOU SAID NOW WE 1369 00:50:12,200 --> 00:50:13,560 DIDN'T USED TO HAVE THESE FENCES 1370 00:50:13,560 --> 00:50:17,480 AND ALL OF THIS BUT WE DO MOW 1371 00:50:17,480 --> 00:50:18,320 AND WE'RE--I ASSUME STUCK WITH 1372 00:50:18,320 --> 00:50:20,480 IT AT LEAST FOR THE FORESEEABLE 1373 00:50:20,480 --> 00:50:22,600 FUTURE WHEN PEOPLE COME TO THAT 1374 00:50:22,600 --> 00:50:25,600 GATEWAY CENTER, THIS THERE BE 1375 00:50:25,600 --> 00:50:26,000 SOME INFORMATION? 1376 00:50:26,000 --> 00:50:27,800 LOOK IF YOU WANT TO COME THROUGH 1377 00:50:27,800 --> 00:50:28,800 HERE, WE WILL CHECK FIRST TO 1378 00:50:28,800 --> 00:50:31,160 LOOK AT THE FOLLOWING THINGS IN 1379 00:50:31,160 --> 00:50:32,960 YOUR RECORD, AND IF THEY COME UP 1380 00:50:32,960 --> 00:50:34,960 THE WRONG WAY, HERE'S WHAT YOU 1381 00:50:34,960 --> 00:50:37,720 SHOULD DO SO YOU SHOULD KNOW 1382 00:50:37,720 --> 00:50:38,000 ABOUT THAT? 1383 00:50:38,000 --> 00:50:39,880 >>SO I WILL DEAL WITH THE 1384 00:50:39,880 --> 00:50:41,080 SECOND 1 FIRST. 1385 00:50:41,080 --> 00:50:43,000 I THINK OWE THAT TO OUR RESEARCH 1386 00:50:43,000 --> 00:50:44,760 PARTICIPANTS WE OFTEN TALK ABOUT 1387 00:50:44,760 --> 00:50:46,640 WHAT WE GET OUT OF RESEARCH, BUT 1388 00:50:46,640 --> 00:50:48,360 THEY'RE GIVING A LOT AND 1389 00:50:48,360 --> 00:50:48,680 ASSUMING RISK. 1390 00:50:48,680 --> 00:50:50,440 I THINK IT'S NOT JUST DURESS, 1391 00:50:50,440 --> 00:50:52,200 THERE ARE OTHER ISSUES LIKE 1392 00:50:52,200 --> 00:50:52,920 IMMIGRATION STATUS WHICH I'M 1393 00:50:52,920 --> 00:50:56,800 SURE IS ALSO CHECKED AND I THINK 1394 00:50:56,800 --> 00:50:59,680 FOR PEOPLE TO COME IN FOR 1395 00:50:59,680 --> 00:51:00,760 HEALTHCARE AND NOT REALIZE THAT 1396 00:51:00,760 --> 00:51:04,720 THOSE THINGS ARE AT RISK OR WILL 1397 00:51:04,720 --> 00:51:06,360 BE EXPOSED, I THINK WE SHOULD 1398 00:51:06,360 --> 00:51:08,560 DISCLOSE THAT AS UNCOMFORTABLE 1399 00:51:08,560 --> 00:51:12,560 AS THAT MAY MAKE US. 1400 00:51:12,560 --> 00:51:15,640 YOU KNOW, I THINK SOMEONE UNDER 1401 00:51:15,640 --> 00:51:16,480 ARREST--SO, TO THE FIRST PART OF 1402 00:51:16,480 --> 00:51:19,520 THE QUESTION, WHETHER IT MATTERS 1403 00:51:19,520 --> 00:51:22,480 WHETHER IT WAS HOMICIDE OR 1404 00:51:22,480 --> 00:51:28,880 NONPAYMENT OF CHILD SUPPORT OR 1405 00:51:28,880 --> 00:51:30,840 THEFT, SO IF YOU LOOK AT 1406 00:51:30,840 --> 00:51:33,480 PRISONER REGS, THEY DON'T MAKE A 1407 00:51:33,480 --> 00:51:33,840 DISTINCTION. 1408 00:51:33,840 --> 00:51:35,720 WOPS YOU'RE A PRISONER, YOU'RE A 1409 00:51:35,720 --> 00:51:36,000 PRISONER. 1410 00:51:36,000 --> 00:51:42,760 SO I THINK SORT OF THE FORMAL 1411 00:51:42,760 --> 00:51:44,720 BRAIN WORK ANALYSIS, WE WOULD 1412 00:51:44,720 --> 00:51:45,760 SAY, NO IT DOESN'T MAKE A 1413 00:51:45,760 --> 00:51:47,640 DIFFERENCE FOR THE ISSUES WE'RE 1414 00:51:47,640 --> 00:51:48,000 DISCUSSING. 1415 00:51:48,000 --> 00:51:49,400 I THINK AS A PRACTICAL MATTER, 1416 00:51:49,400 --> 00:51:51,160 IT WILL MAKERS AND A DIFFERENCE. 1417 00:51:51,160 --> 00:51:53,240 I MEAN I DON'T THINK IF IT WAS 1418 00:51:53,240 --> 00:51:55,160 HOMICIDE, I THINK HIS--YOU KNOW 1419 00:51:55,160 --> 00:51:57,040 HE WOULDN'T HAVE BEEN RELEASED 1420 00:51:57,040 --> 00:51:58,520 FROM POLICE CUSTODY SO FIRST OF 1421 00:51:58,520 --> 00:52:02,160 ALL, YOU KNOW HE'S UNDER ARREST. 1422 00:52:02,160 --> 00:52:03,360 HE HASN'T BEEN CONVICTED. 1423 00:52:03,360 --> 00:52:04,760 HE'S IN THERE GETTING TREATMENT 1424 00:52:04,760 --> 00:52:07,600 BECAUSE OF THE NATURE, I ASSUME 1425 00:52:07,600 --> 00:52:10,240 BECAUSE OF THE NATURE OF 1426 00:52:10,240 --> 00:52:11,120 WARRANTS, AFTER 2 DAYS THE 1427 00:52:11,120 --> 00:52:12,520 POLICE WERE NO LONGER SITTING 1428 00:52:12,520 --> 00:52:18,520 OUTSIDE HIS ROOM AND THAT 1429 00:52:18,520 --> 00:52:20,240 ALLOWED HIM TO LEAVE I WOULD 1430 00:52:20,240 --> 00:52:21,680 ASSUME IF NOTHING ELSE AN ARREST 1431 00:52:21,680 --> 00:52:25,600 FOR SOMETHING LIKE HOMICIDE 1432 00:52:25,600 --> 00:52:26,880 WOULD NOT HAVE ALLOWED THAT TO 1433 00:52:26,880 --> 00:52:30,320 HAPPEN BUT I DON'T THINK WE 1434 00:52:30,320 --> 00:52:31,680 SHOULD BE--IT'S HARD 1435 00:52:31,680 --> 00:52:33,040 TO--DEPENDING ON THE DETAILS OF 1436 00:52:33,040 --> 00:52:34,800 THE CRIME THAT'S ALLEGED, IT 1437 00:52:34,800 --> 00:52:36,280 WILL BE HARD NOT TO HAVE AN 1438 00:52:36,280 --> 00:52:37,920 IMPACT ON THE CARE TEAM AND HOW 1439 00:52:37,920 --> 00:52:39,280 THEY DELIVER CARE. 1440 00:52:39,280 --> 00:52:41,040 OT OTHER HAND IT'S NOT OUR ROLE 1441 00:52:41,040 --> 00:52:46,280 TO JUDGE WHETHER SOMEONE IS 1442 00:52:46,280 --> 00:52:47,360 GUILTY OR DRAW THOSE CONCLUSIONS 1443 00:52:47,360 --> 00:52:49,040 AND I THINK OUR DUTY AS DOCTORS 1444 00:52:49,040 --> 00:52:50,080 AND RESEARCHERS SHOULD BE TO THE 1445 00:52:50,080 --> 00:52:53,080 PATIENT AND THE SCIENCE. 1446 00:52:53,080 --> 00:52:55,280 SO AGAIN, AS A PRACTICAL MATTER, 1447 00:52:55,280 --> 00:53:00,680 IT WOULDN'T MATTER WOULDN'T--WT 1448 00:53:00,680 --> 00:53:02,560 I'M NOT SURE THAT IT SHOULD. 1449 00:53:02,560 --> 00:53:05,560 >>SO I CAN CLARIFY A COUPLE 1450 00:53:05,560 --> 00:53:07,360 THINGS, ON THE PRACTICALITY, 1451 00:53:07,360 --> 00:53:08,880 THERE'S NUANCES AND IT HAS TO DO 1452 00:53:08,880 --> 00:53:11,360 WITH IF A PATIENT WERE TO 1453 00:53:11,360 --> 00:53:13,080 REMARKS RIEF WITH ID OR IF THEY 1454 00:53:13,080 --> 00:53:15,120 DON'T HAVE ID, THEN WHERE THEY 1455 00:53:15,120 --> 00:53:17,320 MIGHT BE KIND OF SMOOTHED 1456 00:53:17,320 --> 00:53:21,800 THROUGH SO TO SPEAK, YEAH, I 1457 00:53:21,800 --> 00:53:25,000 KNOW THAT DR. ROSENFELD, IF 1458 00:53:25,000 --> 00:53:26,960 THERE'S IMMIGRATION ISSUES OR 1459 00:53:26,960 --> 00:53:27,800 NOT, THERE'S CERTAIN WAYS THAT 1460 00:53:27,800 --> 00:53:28,800 PATIENTS ARE ABLE TO GET HERE 1461 00:53:28,800 --> 00:53:31,520 BUT THIS IS A GREAT QUESTION 1462 00:53:31,520 --> 00:53:34,040 THAT WAS ASKED, A MORE GENERAL, 1463 00:53:34,040 --> 00:53:35,240 THAT'S NOT SOMEBODY TAKE THEM 1464 00:53:35,240 --> 00:53:36,680 UNDER REST BUT PEOPLE KNOW IF 1465 00:53:36,680 --> 00:53:38,480 YOU COME TO THIS CAMPUS, YOU'RE 1466 00:53:38,480 --> 00:53:40,240 NOT ALLOWED TO BRING GUNS ON THE 1467 00:53:40,240 --> 00:53:42,800 FEDERAL CAMPUS, EVEN IF YOU HAVE 1468 00:53:42,800 --> 00:53:43,080 A WARRANT. 1469 00:53:43,080 --> 00:53:45,240 SO IF THEY SEARCH YOUR CAR WHEN 1470 00:53:45,240 --> 00:53:46,640 YOU'RE COMING IN AND YOU FIND 1471 00:53:46,640 --> 00:53:48,240 THAT, THEN YOU'RE IN VIOLATION 1472 00:53:48,240 --> 00:53:50,240 OF A FEDERAL LAW AT THAT POINT 1473 00:53:50,240 --> 00:53:52,160 OR DRUGS, LIKE SAY MARIJUANA 1474 00:53:52,160 --> 00:53:56,680 WHICH MIGHT BE LEGAL FOR 1475 00:53:56,680 --> 00:53:57,400 NONCRIMINALLIZED ON WISCONSIN 1476 00:53:57,400 --> 00:53:59,120 AVENUE BUT NOT ONCE YOU CROSS 1477 00:53:59,120 --> 00:54:00,480 THROUGH THE GATE, THOSE SORTS OF 1478 00:54:00,480 --> 00:54:00,840 THINGS. 1479 00:54:00,840 --> 00:54:02,840 SO IT IS A GREAT POINT. 1480 00:54:02,840 --> 00:54:04,720 I DO THINK THAT PATIENTS ARE 1481 00:54:04,720 --> 00:54:06,320 PROVIDED WITH INFORMATION OF YOU 1482 00:54:06,320 --> 00:54:07,400 CAN BRING THIS, YOU CAN'T BRING 1483 00:54:07,400 --> 00:54:09,240 THAT, YOU NEED TO BRING YOUR ID, 1484 00:54:09,240 --> 00:54:11,040 YOU NEED TO BRING THAT. 1485 00:54:11,040 --> 00:54:12,240 THOSE THINGS THEN THEY BUILD UP 1486 00:54:12,240 --> 00:54:13,280 AND YOU HAVE THESE OTHER 1487 00:54:13,280 --> 00:54:14,400 CONSIDERATIONS IF YOU'RE A SICK 1488 00:54:14,400 --> 00:54:21,520 PERSON WHO'S COMING TO THE NIH 1489 00:54:21,520 --> 00:54:23,280 OR THEY MIGHT NOT REMEMBER ALL 1490 00:54:23,280 --> 00:54:24,840 THAT OR THE PERSON WHO DRIVES 1491 00:54:24,840 --> 00:54:26,680 YOU OR COMES WITH YOU, AND 1492 00:54:26,680 --> 00:54:28,400 YOU'VE GOTTEN SICK SO NOW A 1493 00:54:28,400 --> 00:54:29,720 FAMILY MEMBER WANTS TO GET HERE 1494 00:54:29,720 --> 00:54:31,560 AS QUICK AS POSSIBLE AND THEY 1495 00:54:31,560 --> 00:54:32,960 JUDGE UMP IN THEIR CAR AND THEY 1496 00:54:32,960 --> 00:54:34,720 HAVE SOMETHING, PLAIB THAT'S FOR 1497 00:54:34,720 --> 00:54:36,840 ANOTHER DAY BUT WE CAN-- 1498 00:54:36,840 --> 00:54:37,400 >>[LAUGHTER] 1499 00:54:37,400 --> 00:54:38,600 >>BUT DAVID TO YOUR POINT, IF 1500 00:54:38,600 --> 00:54:40,360 YOU TELL PEOPLE THAT AND THEN 1501 00:54:40,360 --> 00:54:42,240 THEY HAVE TO MAKE A CHOICE THEIR 1502 00:54:42,240 --> 00:54:43,640 VISA'S EXPIRED OR SOMETHING LIKE 1503 00:54:43,640 --> 00:54:44,960 THAT AND NONAPOPTOTIC THE IN 1504 00:54:44,960 --> 00:54:45,960 THIS CASE WHERE IT'S STANDARD 1505 00:54:45,960 --> 00:54:48,200 CARE BUT THEY'RE EXPECTING AND 1506 00:54:48,200 --> 00:54:50,480 NEED THAT THERAPY. 1507 00:54:50,480 --> 00:54:52,240 YOU KNOW WHAT DO YOU DO THERE? 1508 00:54:52,240 --> 00:54:54,000 THAT'S NOT AN EASY THING. 1509 00:54:54,000 --> 00:54:55,720 >>THERE SOME THINGS WE ARE ABLE 1510 00:54:55,720 --> 00:54:57,480 TO SMOOTH IT THROUGH BUT OTHERS 1511 00:54:57,480 --> 00:54:57,920 WHERE IT'S NOT. 1512 00:54:57,920 --> 00:55:01,760 DID YOU HAVE OTHER QUESTIONS 1513 00:55:01,760 --> 00:55:03,120 DAVE OR? 1514 00:55:03,120 --> 00:55:04,320 >>YEAH, SO, THIS AN ATTEMPT TO 1515 00:55:04,320 --> 00:55:06,320 PUT TOGETHER, WE ONLY HAVE A 1516 00:55:06,320 --> 00:55:07,640 COUPLE MINUTES LEFT, I THINK I 1517 00:55:07,640 --> 00:55:09,680 ONLY HAVE 2 MINUTES, THIS IS 1518 00:55:09,680 --> 00:55:12,680 TRYING TO SMASH TOGETHER 3 OR 4 1519 00:55:12,680 --> 00:55:14,800 QUESTIONS, WHICH IS BASICALLY 1520 00:55:14,800 --> 00:55:18,600 THAT IT SEEMS LIKE AT LEAST SOME 1521 00:55:18,600 --> 00:55:20,440 OF THE WORRY HERE COMES WHEN 1522 00:55:20,440 --> 00:55:22,560 YOU'RE JUST GETTING STANDARD OF 1523 00:55:22,560 --> 00:55:23,680 CARE, INDICATED CARE WITHIN THE 1524 00:55:23,680 --> 00:55:24,840 CONTEXT OF A RESEARCH PROTOCOL 1525 00:55:24,840 --> 00:55:28,960 AND AS YOU WERE SAYING WHEN THEY 1526 00:55:28,960 --> 00:55:30,040 WERE RETIREDDEN THEY DIDN'T HAVE 1527 00:55:30,040 --> 00:55:31,640 THAT IN MIND, THEY HAD 1528 00:55:31,640 --> 00:55:32,960 EXPERIMENTAL THINGS RISKY THINGS 1529 00:55:32,960 --> 00:55:34,360 LEARN FROM OTHER PEOPLE, 1530 00:55:34,360 --> 00:55:35,720 POTENTIAL FOR EXPLOITING 1531 00:55:35,720 --> 00:55:37,120 SUBJECTS, THEY DIDN'T HAVE 1532 00:55:37,120 --> 00:55:38,760 GIVING SOMEBODY THE KIND OF CARE 1533 00:55:38,760 --> 00:55:42,000 THEY NEED FOR A DEEP VEIN 1534 00:55:42,000 --> 00:55:43,240 THOMBOSIS OR SOMETHING LIKE 1535 00:55:43,240 --> 00:55:43,760 THAT. 1536 00:55:43,760 --> 00:55:46,560 SO IS THERE 1 WAY OR ANOTHER TO 1537 00:55:46,560 --> 00:55:47,040 HANDLE THAT? 1538 00:55:47,040 --> 00:55:49,480 SHOULD IT BE THAT WE JUST DON'T 1539 00:55:49,480 --> 00:55:50,720 DO STANDARD OF CARE PROTOCOLS, 1540 00:55:50,720 --> 00:55:52,760 THAT SHOULDN'T BE WHAT THE NIH'S 1541 00:55:52,760 --> 00:55:54,160 IS IN THE BUSINESS TO DO OR IS 1542 00:55:54,160 --> 00:55:57,080 IT THAT MAYBE THE REGULATIONS 1543 00:55:57,080 --> 00:55:58,720 SHOULDN'T APPLY TO THOSE KINDS 1544 00:55:58,720 --> 00:55:59,880 OF PROTOCOLS BECAUSE YEAH, 1545 00:55:59,880 --> 00:56:01,320 THEY'RE UNDER THE UMBRELLA OF 1546 00:56:01,320 --> 00:56:04,320 RESEARCH BUT LOOK, WE'RE JUST 1547 00:56:04,320 --> 00:56:06,240 GIVING SOMEBODY CLINICALLY 1548 00:56:06,240 --> 00:56:06,920 INDICATED CARE. 1549 00:56:06,920 --> 00:56:09,000 IS THERE ANY ROOM ON EITHER OF 1550 00:56:09,000 --> 00:56:11,800 THOSE SIDES TO TRY TO HELP WITH 1551 00:56:11,800 --> 00:56:12,160 THIS DILEMMA. 1552 00:56:12,160 --> 00:56:14,240 >>I BELIEVE STRONGLY WHEN I WAS 1553 00:56:14,240 --> 00:56:16,400 AT NIH, SOMETHING LIKE 50% OF 1554 00:56:16,400 --> 00:56:17,520 THE STUDIES WERE NATURAL HISTORY 1555 00:56:17,520 --> 00:56:19,240 STUDIES AND I WAS IN THE 1556 00:56:19,240 --> 00:56:21,240 HEMEATOLOGY GROUP AND WE WERE 1557 00:56:21,240 --> 00:56:22,520 STUDYING THINGS LIKE 1558 00:56:22,520 --> 00:56:23,640 [INDISCERNIBLE] ANEMIA AND SUCH, 1559 00:56:23,640 --> 00:56:24,760 WHICH AT THE TIME THERE WAS NO 1560 00:56:24,760 --> 00:56:26,000 THERAPY FOR AND IT WAS 1561 00:56:26,000 --> 00:56:26,680 INCREDIBLE LOAMACYY IMPORTANT 1562 00:56:26,680 --> 00:56:28,320 THAT WE HAD THOSE 1563 00:56:28,320 --> 00:56:28,920 PEOPLE--INCREDIBLE LOAMACYY 1564 00:56:28,920 --> 00:56:29,640 IMPORTANT THAT WE HAD THOSE 1565 00:56:29,640 --> 00:56:31,840 PEOPLE COME AND WHAT WE GAVE 1566 00:56:31,840 --> 00:56:33,680 THEM FOR EXCHANGE FOR THEIR TIME 1567 00:56:33,680 --> 00:56:35,920 AND SPECIMENS AND DATA WAS WE 1568 00:56:35,920 --> 00:56:36,640 PROVIDED CARE AND IT WASN'T THAT 1569 00:56:36,640 --> 00:56:40,280 THEY COULD BT GET THE CARE 1570 00:56:40,280 --> 00:56:40,560 ELSEWHERE. 1571 00:56:40,560 --> 00:56:42,480 AND I THINK THAT PARTICULARLY IN 1572 00:56:42,480 --> 00:56:45,400 TODAY'S DAY, YOU KNOW ERA OF BIG 1573 00:56:45,400 --> 00:56:49,800 DATA AND AI AND ML, AND 1574 00:56:49,800 --> 00:56:52,560 INCREASING TOOL KIT TO MAKE 1575 00:56:52,560 --> 00:56:56,240 INFORMATION ITSELF VALUABLE AND 1576 00:56:56,240 --> 00:56:57,840 BIO--GENOMICS BEFORE THE HUMAN 1577 00:56:57,840 --> 00:56:59,240 GENOME PROJECT, THE FACT THAT WE 1578 00:56:59,240 --> 00:57:00,880 CAN DO WHOLE GENOME SEQUENCES 1579 00:57:00,880 --> 00:57:03,560 AND LOOK FOR THINGS, ALL OF THAT 1580 00:57:03,560 --> 00:57:05,000 IS RESEARCH OF ENORMOUS VALUE 1581 00:57:05,000 --> 00:57:07,680 AND I DON'T THINK THERE SHOULD 1582 00:57:07,680 --> 00:57:09,120 BE ANY LIMITATIONS ON THE 1583 00:57:09,120 --> 00:57:10,800 CLINICAL CENTER IF ARE PRACTICES 1584 00:57:10,800 --> 00:57:13,080 VIEDING THAT, THAT'S 1 OF THE 1585 00:57:13,080 --> 00:57:14,560 UNIQUE THINGS THAT NIH AND THE 1586 00:57:14,560 --> 00:57:15,600 CLINICAL CENTER CAN DO BECAUSE 1587 00:57:15,600 --> 00:57:17,840 IT'S NOT DRIVEN BY 1588 00:57:17,840 --> 00:57:19,400 PHARMACEUTICAL DRUG OR DEVICE 1589 00:57:19,400 --> 00:57:20,560 DEVELOPMENT, SO THERE'S NO MONEY 1590 00:57:20,560 --> 00:57:23,240 BEHIND IT SO YOU HAVE FEDERAL 1591 00:57:23,240 --> 00:57:26,240 FUNDS THAT FUND THIS BASIC 1592 00:57:26,240 --> 00:57:27,840 SCIENCE OR YOU KNOW, SO I THINK 1593 00:57:27,840 --> 00:57:34,400 THE ANSWER SHOULD BE NO 1594 00:57:34,400 --> 00:57:35,120 CONSTRAINTS ON THAT. 1595 00:57:35,120 --> 00:57:38,720 I THINK, YOU KNOW SO PUT ASIDE 1596 00:57:38,720 --> 00:57:39,880 THE PRISONER REGS, I DON'T THINK 1597 00:57:39,880 --> 00:57:42,440 THAT THE REST OF THE REGULATIONS 1598 00:57:42,440 --> 00:57:47,800 HAVE PROBLEMS WITH THAT KIND OF 1599 00:57:47,800 --> 00:57:48,080 RESEARCH. 1600 00:57:48,080 --> 00:57:57,600 AND SO, YOU KNOW THE CONSTRAINTS 1601 00:57:57,600 --> 00:57:58,600 ON VULNERABLE POPULATIONS I DO 1602 00:57:58,600 --> 00:57:59,800 THINK YOU SHOULD THINK THAT THE 1603 00:57:59,800 --> 00:58:01,840 IRB AND THE SCIENTISTS WRITING 1604 00:58:01,840 --> 00:58:05,080 THE PROTOCOL SHOULD THINK ABOUT 1605 00:58:05,080 --> 00:58:08,120 THE VALUE OF THE THINGS THAT 1606 00:58:08,120 --> 00:58:08,960 THEY--SO, POPULATIONS ARE 1607 00:58:08,960 --> 00:58:10,480 VULNERABLE BECAUSE THEY 1608 00:58:10,480 --> 00:58:11,400 TYPICALLY HAVE IMPAIRMENTS OF 1609 00:58:11,400 --> 00:58:15,320 THEIR ABILITY TO GIVE INFORMED 1610 00:58:15,320 --> 00:58:15,760 AND VOLUNTARY CONSENT. 1611 00:58:15,760 --> 00:58:17,480 IF YOU KNOW THAT AHEAD OF TIME, 1612 00:58:17,480 --> 00:58:22,400 YOU SHOULD HAVE A HIGHER BAR 1613 00:58:22,400 --> 00:58:23,240 GETTING THOSE PEOPLE IN 1614 00:58:23,240 --> 00:58:23,520 RESEARCH. 1615 00:58:23,520 --> 00:58:24,720 IF IT'S A RARE DISEASE PROTOCOL 1616 00:58:24,720 --> 00:58:26,320 AND YOU SHOULD KNOW, BUT YOU 1617 00:58:26,320 --> 00:58:27,920 SHOULD TAKE THE SCIENCE INTO 1618 00:58:27,920 --> 00:58:28,440 ACCOUNT. 1619 00:58:28,440 --> 00:58:29,600 IF THERE ARE 15 PEOPLE IN THE 1620 00:58:29,600 --> 00:58:30,960 WORLD WITH THAT DISORDER, YOU 1621 00:58:30,960 --> 00:58:32,080 KNOW THAT MATTERS. 1622 00:58:32,080 --> 00:58:34,600 SO, YOU KNOW THERE'S NO EASY 1623 00:58:34,600 --> 00:58:35,240 ANSWER. 1624 00:58:35,240 --> 00:58:35,640 >>YEAH. 1625 00:58:35,640 --> 00:58:36,800 >>ALL RIGHT. 1626 00:58:36,800 --> 00:58:39,120 WELL, I WANT TO THANK BOTH DAVID 1627 00:58:39,120 --> 00:58:40,600 FOR A VERY RICH AND INTERESTING 1628 00:58:40,600 --> 00:58:44,480 CASE THAT HE BROUGHT AND STEPHEN 1629 00:58:44,480 --> 00:58:46,680 FOR SOME FABULOUS SUGGESTIONS 1630 00:58:46,680 --> 00:58:47,040 AND COMMENTS. 1631 00:58:47,040 --> 00:58:48,480 WE REALLY APPRECIATE IT, MAYBE 1632 00:58:48,480 --> 00:58:50,960 SOMEDAY IN THE FUTURE STEPHEN WE 1633 00:58:50,960 --> 00:58:52,880 WILL DRAG YOU BACK HERE FOR 1634 00:58:52,880 --> 00:58:54,280 DISCUSSION OF ETHICS OF IRB 1635 00:58:54,280 --> 00:58:55,960 REVIEW WOULD BE GREAT BUT IN THE 1636 00:58:55,960 --> 00:58:59,000 MEAN TIME, THANK YOU GUYS AND 1637 00:58:59,000 --> 00:59:00,360 APPRECIATION OF EVERYBODY FOR 1638 00:59:00,360 --> 00:59:01,960 REALLY WONDERFUL SESSION AND 1639 00:59:01,960 --> 00:59:04,440 JUST A REMINDER THAT THE NEXT 1640 00:59:04,440 --> 00:59:05,760 ETHICS GRAND ROUNDS WHERE PEOPLE 1641 00:59:05,760 --> 00:59:08,040 ARE KEEPING TRACK IS THE FIRST 1642 00:59:08,040 --> 00:59:09,640 WEDNESDAY OF DECEMBER AT NOON 1643 00:59:09,640 --> 00:59:11,840 AND THAT WILL ALSO BE VIRTUAL 1644 00:59:11,840 --> 00:59:14,040 RIGHT HERE ON NIH VIDEOCAST. 1645 00:59:14,040 --> 00:59:15,680 HOPE TO SEE EVERYBODY THEN AND 1646 00:59:15,680 --> 00:59:18,080 IN THE MEAN TIME THANKS AGAIN, 1647 00:59:18,080 --> 00:00:00,000 YOU GUYS, BYE-BYE.