1 00:00:05,405 --> 00:00:08,575 THANK YOU FOR JOINING 2 00:00:08,641 --> 00:00:11,978 US FOR TODAY'S OHSRP EDUCATION 3 00:00:12,045 --> 00:00:12,579 SERIES SESSION TITLED OHSRP 4 00:00:12,645 --> 00:00:13,179 EDUCATION SERIES SESSION: KEY 5 00:00:13,246 --> 00:00:13,747 ETHICAL ISSUES IN PEDIATRIC 6 00:00:13,813 --> 00:00:15,949 RESEARCH OUR SPEAKER FOR TODAY 7 00:00:16,015 --> 00:00:18,818 IS DR. DAVID WENDLER. 8 00:00:18,885 --> 00:00:21,354 A PHILOSOPHER WHO TRAINED 9 00:00:21,421 --> 00:00:21,755 IN THE PHILOSOPHY 10 00:00:21,821 --> 00:00:22,122 OF SCIENCE. 11 00:00:22,188 --> 00:00:22,856 HE HAS BEEN AT THE NIH FOR 30 12 00:00:22,922 --> 00:00:24,424 YEARS, 13 00:00:24,491 --> 00:00:25,358 FIRST AS A FELLOW AND CURRENTLY 14 00:00:25,425 --> 00:00:26,326 AS A SENIOR INVESTIGATOR AND 15 00:00:26,393 --> 00:00:27,827 HEAD OF THE SECTION 16 00:00:27,894 --> 00:00:28,661 ON RESEARCH ETHICS IN THE NIH 17 00:00:28,728 --> 00:00:29,362 CLINICAL CENTER DEPARTMENT OF 18 00:00:29,429 --> 00:00:34,334 BIOETHICS. 19 00:00:34,401 --> 00:00:35,502 HE HAS WRITTEN WIDELY ON SUCH 20 00:00:35,568 --> 00:00:36,803 TOPICS, ASSESSING 21 00:00:36,870 --> 00:00:47,347 SYSTEMATICALLY, RESPECT FOR 22 00:00:57,390 --> 00:00:57,857 AUTONOMY, ASSENT IN PEDIATRIC 23 00:00:57,924 --> 00:00:58,491 RESEARCH, RESEARCH WITH STORED 24 00:00:58,558 --> 00:01:00,860 BIOLOGICAL SAMPLES. 25 00:01:00,927 --> 00:01:04,464 THE SLIDE WILL BE POSTED ON THE 26 00:01:04,531 --> 00:01:05,098 NIH'S WEBSITE WANTED TO WEEK 27 00:01:05,165 --> 00:01:08,034 LATER. THROUGHOUT THE SESSION 28 00:01:08,101 --> 00:01:09,969 WE ENCOURAGE VIEWERS TO SUBMIT 29 00:01:10,036 --> 00:01:10,570 QUESTIONS BY CLICKING ON THE 30 00:01:10,637 --> 00:01:13,540 BOX BELOW THE VIDEO, TITLED 31 00:01:13,606 --> 00:01:16,476 "LIVE THE FEEDBACK LINK." 32 00:01:16,543 --> 00:01:18,044 PLEASE GO AHEAD AND I WILL LET 33 00:01:18,111 --> 00:01:16,810 YOU GET STARTED. 34 00:01:16,810 --> 00:01:23,183 >> DR. WENDLER: THANKS PEG. AND 35 00:01:23,249 --> 00:01:24,384 THANKS FOR HAVING ME. I'M 36 00:01:24,451 --> 00:01:25,018 GOING TO TALK ABOUT KEY ETHICAL 37 00:01:25,084 --> 00:01:26,319 ISSUES IN PEDIATRIC RESEARCH. 38 00:01:26,386 --> 00:01:31,191 BUT I WILL TRY TO DO IS GIVE A 39 00:01:31,257 --> 00:01:31,825 GENERAL CONSENSUS VIEWS. BUT 40 00:01:31,891 --> 00:01:32,392 ALSO AS YOU ARE SEEING IN A 41 00:01:32,459 --> 00:01:34,994 NUMBER OF PLACES, I'M GOING TO 42 00:01:35,061 --> 00:01:36,996 GIVE YOU MY OWN VIEWS, WOULD 43 00:01:37,063 --> 00:01:38,364 SOMETIMES ARE SIMILAR TO THE 44 00:01:38,431 --> 00:01:38,965 CONSENSUS USE. SOMETIMES WILL 45 00:01:39,032 --> 00:01:42,235 BE DIFFERENT. I WILL TRY TO 46 00:01:42,302 --> 00:01:42,869 FLAG THOSE DIFFERENCES AND THEN 47 00:01:42,936 --> 00:01:43,503 WE CAN DISCUSS THEM IF PEOPLE 48 00:01:43,570 --> 00:01:44,471 ARE INTERESTED. 49 00:01:44,537 --> 00:01:45,839 IN TERMS OF THE ISSUES I AM 50 00:01:45,905 --> 00:01:49,476 GOING TO FOCUS ON THESE FIVE, I 51 00:01:49,542 --> 00:01:50,076 SHOULD SAY THAT I HAVE TALKS 52 00:01:50,143 --> 00:01:50,710 THAT TAKE AN HOUR FOR EACH ONE 53 00:01:50,777 --> 00:01:55,148 OF THESE FIVES. TODAY, OUT OF 54 00:01:55,215 --> 00:01:55,782 NECESSITY, WILL DO A HIGH-LEVEL 55 00:01:55,849 --> 00:01:58,251 GENERAL ASSESSMENT OF EACH OF 56 00:01:58,318 --> 00:02:00,587 THEM IN THEN I'M HOPING TO 57 00:02:00,653 --> 00:02:01,187 LEAVE SOMETIME AT THE END TO 58 00:02:01,254 --> 00:02:03,056 ALLOW US TO FOCUS IN ON THE 59 00:02:03,122 --> 00:02:03,690 ONES THAT PEOPLE FIND THE MOST 60 00:02:03,756 --> 00:02:04,524 INTERESTING. OR THE MOST 61 00:02:04,591 --> 00:02:06,993 PRESSING. 62 00:02:07,060 --> 00:02:07,460 FIRST THE IMPORTANCE OF 63 00:02:07,527 --> 00:02:12,532 PEDIATRIC RESEARCH. THIS ONE 64 00:02:12,599 --> 00:02:13,099 HOPEFULLY FOR THIS AUDIENCE 65 00:02:13,166 --> 00:02:13,566 SHOULD BE RELATIVELY 66 00:02:13,633 --> 00:02:14,501 STRAIGHTFORWARD. 67 00:02:14,567 --> 00:02:18,371 AS EVERYBODY KNOWS, INFORMED 68 00:02:18,438 --> 00:02:19,172 CONSENT IS AT LEAST ONE OF, IF 69 00:02:19,239 --> 00:02:20,306 NOT THE KEY ETHICAL SAFEGUARDS 70 00:02:20,373 --> 00:02:23,276 FOR CLINICAL RESEARCH. AND THAT 71 00:02:23,343 --> 00:02:24,677 RAISES CONCERNS ABOUT WHAT WE 72 00:02:24,744 --> 00:02:26,713 DO TO PROTECT INDIVIDUAL CAN'T 73 00:02:26,779 --> 00:02:31,184 GIVE INFORMED CONSENT. SOME 74 00:02:31,251 --> 00:02:31,751 REGULATIONS AND GUIDELINES 75 00:02:31,818 --> 00:02:32,385 PROHIBIT THEIR ENROLLMENT AS A 76 00:02:32,452 --> 00:02:33,586 MEANS OF PROTECTION. THE 77 00:02:33,653 --> 00:02:38,391 EXAMPLE HERE IS A NüRNBERG CODE 78 00:02:38,458 --> 00:02:38,992 WHICH PEOPLE MIGHT KNOW TALK 79 00:02:39,058 --> 00:02:39,592 ABOUT THE INFORMED CONSENT OF 80 00:02:39,659 --> 00:02:41,861 THE INDIVIDUAL BEING WHAT IS 81 00:02:41,928 --> 00:02:45,798 CALLED "ESSENTIAL" TO ETHICAL 82 00:02:45,865 --> 00:02:46,432 RESEARCH SUGGESTING YOU SHOULD 83 00:02:46,499 --> 00:02:47,000 NOT ENROLL PEOPLE WHO CAN'T 84 00:02:47,066 --> 00:02:48,001 CONSENT. 85 00:02:48,067 --> 00:02:48,568 THAT APPROACH HAS A NUMBER OF 86 00:02:48,635 --> 00:02:52,138 VIRTUES. IT OFFERS STRONG 87 00:02:52,205 --> 00:02:54,674 PROTECTION FOR INDIVIDUAL CAN'T 88 00:02:54,741 --> 00:02:55,475 CONSENT, FROM BOTH EXPLOITATION 89 00:02:55,542 --> 00:03:01,681 AND FROM BEING EXPOSED TO 90 00:03:01,748 --> 00:03:02,282 EXCESSIVE RESEARCH RISKS AND 91 00:03:02,348 --> 00:03:02,916 CANNOT BE ENROLLED IN RESEARCH, 92 00:03:02,982 --> 00:03:03,449 AND CANNOT BE EXPOSED IN 93 00:03:03,516 --> 00:03:08,955 EXCESSIVE RESEARCH RISKS. 94 00:03:09,022 --> 00:03:09,489 IT HAS OBVIOUSLY IMPORTANT 95 00:03:09,556 --> 00:03:10,123 DOWNSIDE. IF YOU'RE NOT ALLOWED 96 00:03:10,189 --> 00:03:11,791 TO BE IN RESEARCH, YOU CANNOT 97 00:03:11,858 --> 00:03:12,425 ENGAGE IN STUDIES THAT MIGHT BE 98 00:03:12,492 --> 00:03:15,328 BENEFICIAL TO YOU. FOR EXAMPLE 99 00:03:15,395 --> 00:03:18,197 PEOPLE WHO HAVE A CONDITION FOR 100 00:03:18,264 --> 00:03:20,033 WHICH THERE IS NO APPROVED 101 00:03:20,099 --> 00:03:20,567 TREATMENT, SOMETIMES CAN 102 00:03:20,633 --> 00:03:21,134 BENEFIT SIGNIFICANTLY FROM 103 00:03:21,200 --> 00:03:21,734 ROLLING ON A RESEARCH TRIAL. 104 00:03:21,801 --> 00:03:22,302 AND THEY ARE PREVENTED FROM 105 00:03:22,368 --> 00:03:25,338 THIS APPROACH. ALSO UNDERMINES 106 00:03:25,405 --> 00:03:25,905 RESEARCH ON THE CONDITIONS 107 00:03:25,972 --> 00:03:28,741 WHICH AFFECT THESE INDIVIDUALS 108 00:03:28,808 --> 00:03:29,375 IN TRYING TO FIND A BETTER AND 109 00:03:29,442 --> 00:03:32,345 IMPROVED TREATMENTS FOR THEM. 110 00:03:32,412 --> 00:03:40,453 SO THAT LED US-- THIS 111 00:03:40,520 --> 00:03:41,054 PROTECTIONIST MODE LED US TO 112 00:03:41,120 --> 00:03:43,256 THE SITUATION WE ARE IN WHICH 113 00:03:43,323 --> 00:03:47,260 TODAY. ESTIMATES VARY, 60 TO 114 00:03:47,327 --> 00:03:47,827 80%, A LOT OF INTERVENTIONS 115 00:03:47,894 --> 00:03:48,461 USED IN CHILDREN HAVE NOT BEEN 116 00:03:48,528 --> 00:03:49,629 ASSESSED SYSTEMATICALLY, 117 00:03:49,696 --> 00:03:50,163 EVALUATED AND TESTED AND 118 00:03:50,229 --> 00:03:53,733 APPROVED IN CHILDREN. INSTEAD, 119 00:03:53,800 --> 00:03:55,335 THEY HAVE BEEN TESTED IN ADULTS 120 00:03:55,401 --> 00:03:55,835 AND JUST BEING USED IN 121 00:03:55,902 --> 00:03:56,469 CHILDREN. BUT OF COURSE 122 00:03:56,536 --> 00:03:57,270 CHILDREN ARE NOT 123 00:03:57,337 --> 00:03:59,072 PHYSIOLOGICALLY JUST LITTLE 124 00:03:59,138 --> 00:04:00,640 ADULTS. AND THAT IS PROBLEMATIC. 125 00:04:00,707 --> 00:04:03,176 WHAT WE NEED TO DO INSTEAD TO 126 00:04:03,242 --> 00:04:04,844 IMPROVE PEDIATRIC CLINICAL 127 00:04:04,911 --> 00:04:05,411 CARE, IS WE NEED PEDIATRIC 128 00:04:05,478 --> 00:04:08,348 RESEARCH. SO WE NEED TO ENROLL 129 00:04:08,414 --> 00:04:11,884 MINORS IN RESEARCH. AND IF WE 130 00:04:11,951 --> 00:04:12,452 ARE GOING TO DO THAT IN AN 131 00:04:12,518 --> 00:04:13,686 ETHICAL WAY, WE NEED TO FIGURE 132 00:04:13,753 --> 00:04:15,521 OUT WHAT THE CONDITIONS ARE. 133 00:04:15,588 --> 00:04:18,992 THOSE ARE THE ONES THAT I AM 134 00:04:19,058 --> 00:04:20,893 GOING TO TALK ABOUT TODAY, ARE 135 00:04:20,960 --> 00:04:21,461 DOING THIS IN AN ETHICALLY 136 00:04:21,527 --> 00:04:25,531 APPROPRIATE WAY. 137 00:04:25,598 --> 00:04:26,032 WHAT ARE CALLED NET RISK 138 00:04:26,099 --> 00:04:32,805 PEDIATRIC RESEARCH. AT A 139 00:04:32,872 --> 00:04:33,339 GENERAL LEVEL THIS IS THE 140 00:04:33,406 --> 00:04:33,940 PRIMARY ETHICAL CONSIDERATION 141 00:04:34,007 --> 00:04:34,941 AND CONCERNED COMES UP WHEN YOU 142 00:04:35,008 --> 00:04:35,575 THINK ABOUT ENROLLING CHILDREN 143 00:04:35,642 --> 00:04:39,479 IN RESEARCH. 144 00:04:39,545 --> 00:04:40,013 TO START WITH THE ONES THAT 145 00:04:40,079 --> 00:04:41,381 DON'T SEEM AS PROBLEMATIC, 146 00:04:41,447 --> 00:04:43,916 PROSPECT OF BENEFIT, THE US 147 00:04:43,983 --> 00:04:44,550 RELATIONS CALL THIS PROSPECT OF 148 00:04:44,617 --> 00:04:46,953 DIRECT BENEFIT, IT IS WIDELY 149 00:04:47,020 --> 00:04:47,553 AGREED THAT IT CAN BE ETHICAL 150 00:04:47,620 --> 00:04:50,156 TO UNROLL CHILDREN IN RESEARCH 151 00:04:50,223 --> 00:04:52,759 EVEN THOUGH THEY CAN'T CONSENT. 152 00:04:52,825 --> 00:04:53,259 WHEN THE RESEARCH HAS 153 00:04:53,326 --> 00:04:55,361 IMPORTANT SOCIAL VALUE AND IT 154 00:04:55,428 --> 00:04:57,230 ALSO OFFERS THE PARTICIPANTS 155 00:04:57,296 --> 00:04:59,532 THE PROSPECT OF A BENEFIT. 156 00:04:59,599 --> 00:05:02,602 I WILL TAKE THE OPPORTUNITY TO 157 00:05:02,669 --> 00:05:03,236 BEAT A COUPLE OF DRUMS. THIS IS 158 00:05:03,302 --> 00:05:05,638 ONE BEFORE WE GET TO NET RISK, 159 00:05:05,705 --> 00:05:10,343 JUST TO SAY THAT QUALIFYING AS 160 00:05:10,410 --> 00:05:10,943 PROSPECT OF DIRECT BENEFIT OF 161 00:05:11,010 --> 00:05:13,012 RESEARCH IS NOT SUFFICIENT THAT 162 00:05:13,079 --> 00:05:14,747 THE RESEARCH JUST OFFERS ANY 163 00:05:14,814 --> 00:05:15,381 CHANCE OF POTENTIAL BENEFIT TO 164 00:05:15,448 --> 00:05:19,519 PARTICIPANTS. INSTEAD AND I 165 00:05:19,585 --> 00:05:20,420 THINK THIS IS A PLACE WHERE THE 166 00:05:20,486 --> 00:05:21,054 US REGULATIONS ARE CLEAR, AND 167 00:05:21,120 --> 00:05:23,256 ESSENTIALLY RIGHT, YOU HAVE TO 168 00:05:23,322 --> 00:05:26,392 SATISFY THESE TWO CONDITIONS. 169 00:05:26,459 --> 00:05:26,959 NOT JUST THAT THERE IS SOME 170 00:05:27,026 --> 00:05:27,493 POTENTIAL FOR BENEFIT THE 171 00:05:27,560 --> 00:05:29,595 PARTICIPANTS. BUT THAT THE 172 00:05:29,662 --> 00:05:31,931 POTENTIAL BENEFITS FOR THE 173 00:05:31,998 --> 00:05:32,565 PARTICIPANTS JUSTIFY THE RISKS 174 00:05:32,632 --> 00:05:34,567 THAT THEY FACE. 175 00:05:34,634 --> 00:05:35,134 AND ALSO THEY HAVE TO CONVEY 176 00:05:35,201 --> 00:05:37,503 THE ALTERNATIVES. THE 177 00:05:37,570 --> 00:05:38,104 RISK-BENEFIT PROFILE OF BEING 178 00:05:38,171 --> 00:05:39,305 IN THE RESEARCH, THESE ARE THE 179 00:05:39,372 --> 00:05:42,742 WORDS OF THE US REGS, AT LEAST 180 00:05:42,809 --> 00:05:43,342 AS FAVORABLE AS THE AVAILABLE 181 00:05:43,409 --> 00:05:51,484 ALTERNATIVES. IF THERE ARE 182 00:05:51,551 --> 00:05:52,118 NOT, THERE IS A SENSE IN WHICH 183 00:05:52,185 --> 00:05:52,752 THEY WOULD BE BETTER OFF BEING 184 00:05:52,819 --> 00:05:54,554 OUTSIDE OF THE RESEARCH AND 185 00:05:54,620 --> 00:05:55,188 JUST GETTING CLINICAL CARE. SO 186 00:05:55,254 --> 00:05:55,788 THAT IS THE CLINICAL PROSPECT 187 00:05:55,855 --> 00:05:58,024 OF BENEFIT. 188 00:05:58,091 --> 00:05:58,558 WHAT ABOUT RESEARCH STUDIES 189 00:05:58,624 --> 00:05:59,425 THAT DON'T SATISFY THESE 190 00:05:59,492 --> 00:06:01,060 CONDITIONS? THESE ARE STUDIES 191 00:06:01,127 --> 00:06:03,429 WHERE THE POTENTIAL BENEFITS TO 192 00:06:03,496 --> 00:06:05,732 PARTICIPANTS DON'T JUSTIFY THE 193 00:06:05,798 --> 00:06:06,332 RISKS. OR TO PUT IT THE OTHER 194 00:06:06,399 --> 00:06:07,433 WAY, THE RISKS EXCEED THE 195 00:06:07,500 --> 00:06:09,168 POTENTIAL BENEFITS. AND JUST 196 00:06:09,235 --> 00:06:11,304 FOR CONVENIENCE OUR CALL THESE 197 00:06:11,370 --> 00:06:13,573 NET RISK STUDIES OR NET RISK 198 00:06:13,639 --> 00:06:15,241 PEDIATRIC RESEARCH. PEOPLE USE 199 00:06:15,308 --> 00:06:19,545 DIFFERENT TERMS. 200 00:06:19,612 --> 00:06:20,079 HERE ARE EXAMPLE OF THINGS 201 00:06:20,146 --> 00:06:20,680 WHERE YOU ARE GOING TO GET A 202 00:06:20,747 --> 00:06:21,881 PURELY RESEARCH BLOOD DRAW, OR 203 00:06:21,948 --> 00:06:25,952 PURELY RESEARCH SKIN BIOPSY. 204 00:06:26,018 --> 00:06:26,519 WE DID SOME EVALUATIONS WE 205 00:06:26,586 --> 00:06:30,490 STUDY ABOUT FIVE YEARS AGO, 206 00:06:30,556 --> 00:06:31,124 WHERE THEY WERE JUST ENROLLING 207 00:06:31,190 --> 00:06:31,657 HEALTHY TEENS INTO AN MRI 208 00:06:31,724 --> 00:06:34,927 STUDY, JUST TO LOOK AT THEIR 209 00:06:34,994 --> 00:06:35,561 BRAINS AND THEN COMPARE THEM TO 210 00:06:35,628 --> 00:06:36,262 THE BRAINS OF PEOPLE WITH 211 00:06:36,329 --> 00:06:42,769 AUTISM. THOSE SCANS FOR THE 212 00:06:42,835 --> 00:06:43,803 HEALTHY VOLUNTEERS DID NOT DID 213 00:06:43,870 --> 00:06:44,403 ANYTHING, AND THEY WERE HIGH 214 00:06:44,470 --> 00:06:46,405 RISKS. THAT QUALIFIES UNDER 215 00:06:46,472 --> 00:06:48,274 THE SCHEME OF NET RISK 216 00:06:48,341 --> 00:06:49,375 PEDIATRIC RESEARCH. 217 00:06:49,442 --> 00:06:52,712 THIS WAS THE BIGGEST DEBATE. 218 00:06:52,779 --> 00:06:53,246 FOR PEOPLE WHO KNOWS THE 219 00:06:53,312 --> 00:06:55,581 FEDERAL REGULATIONS AS WE HAVE 220 00:06:55,648 --> 00:06:58,384 THEM TODAY TRACE TO THE WORK OF 221 00:06:58,451 --> 00:06:59,018 THE US NATIONAL COMMISSION IN 222 00:06:59,085 --> 00:07:01,554 THE 1970S. THIS WAS THE 223 00:07:01,621 --> 00:07:02,688 BIGGEST FIGHT AND THE BIGGEST 224 00:07:02,755 --> 00:07:09,295 DEBATE. ACTUALLY THE ONE THAT 225 00:07:09,362 --> 00:07:09,829 LED TO A COUPLE OF PUBLIC 226 00:07:09,896 --> 00:07:10,663 DISAGREEMENTS THAT WERE 227 00:07:10,730 --> 00:07:11,264 WRITTEN, AND ARE INTERESTING 228 00:07:11,330 --> 00:07:11,864 READING FOR ANYBODY LIKE THAT 229 00:07:11,931 --> 00:07:12,498 SORT OF STUFF. AND THAT DEBATE 230 00:07:12,565 --> 00:07:14,667 CONTINUES TODAY. 231 00:07:14,734 --> 00:07:15,268 HERE'S SOME DATA FROM ABOUT 15 232 00:07:15,334 --> 00:07:18,905 YEARS AGO. STUDIES THAT 233 00:07:18,971 --> 00:07:19,505 SUGGESTED THAT PEDIATRICIANS 234 00:07:19,572 --> 00:07:21,974 AND RESEARCH IN CANADA AND THE 235 00:07:22,041 --> 00:07:22,508 UK, ALMOST HALF OF THEM 236 00:07:22,575 --> 00:07:25,945 THOUGHT WHAT I AM CALLING NET 237 00:07:26,012 --> 00:07:31,717 RISK RESEARCH WAS UNACCEPTABLE 238 00:07:31,784 --> 00:07:32,318 AND CANADIAN MEDICAL STUDENTS 239 00:07:32,385 --> 00:07:34,520 AND SEEM TO HAVE A SIMILAR 240 00:07:34,587 --> 00:07:35,154 VIEW. SO WE NEED TO ASSESS THEM 241 00:07:35,221 --> 00:07:35,655 AND FIGURE OUT WHEN THE 242 00:07:35,721 --> 00:07:40,493 RESEARCH IS ACCEPTABLE. 243 00:07:40,560 --> 00:07:41,027 SO HOW DO WE TRY TO ADDRESS 244 00:07:41,093 --> 00:07:42,328 THIS? THE US RELATIONS DO THIS 245 00:07:42,395 --> 00:07:42,962 THAT INITIALLY STRIKES ME AS A 246 00:07:43,029 --> 00:07:44,764 GOOD IDEA. WHAT THEY SAID IS, 247 00:07:44,831 --> 00:07:47,433 WE'RE WORRIED ABOUT THESE NET 248 00:07:47,500 --> 00:07:49,268 RISKS OF PEDIATRIC RESEARCH. 249 00:07:49,335 --> 00:07:49,902 TO EVALUATE THEM LET'S COMPARE 250 00:07:49,969 --> 00:07:52,638 THEM TO OTHER RISKS THAT 251 00:07:52,705 --> 00:07:53,272 CHILDREN FACE THAT WE THINK ARE 252 00:07:53,339 --> 00:07:57,543 ACCEPTABLE. AND THE REGS DO 253 00:07:57,610 --> 00:07:58,144 THIS IN TERMS OF THE RISKS OF 254 00:07:58,211 --> 00:08:00,913 DAILY LIFE, RISKS ORDINARILY 255 00:08:00,980 --> 00:08:07,220 ENCOUNTERED IN DAILY LIFE. 256 00:08:07,286 --> 00:08:07,820 NOW, HERE IS MY PERSONAL SHTICK 257 00:08:07,887 --> 00:08:10,223 ON THE MINIMAL RISK STANDARD. 258 00:08:10,289 --> 00:08:13,025 A LOT OF THE RISKS THE CHILDREN 259 00:08:13,092 --> 00:08:13,559 TO PACING DAILY LIFE ARE 260 00:08:13,626 --> 00:08:14,193 ASSOCIATED WITH ACTIVITIES THAT 261 00:08:14,260 --> 00:08:14,861 HAVE BENEFITS. LIKE YOUR 262 00:08:14,927 --> 00:08:18,631 PARENTS TAKE YOU SNOW SKIING. 263 00:08:18,698 --> 00:08:19,265 IF YOU'RE LUCKY SNOW SKIING IS 264 00:08:19,332 --> 00:08:21,734 A FAIRLY RISKY ENDEAVOR. THE 265 00:08:21,801 --> 00:08:22,335 REASON WHY PARENTS THINK THAT 266 00:08:22,401 --> 00:08:25,238 IS ACCEPTABLE FOR THEIR 267 00:08:25,304 --> 00:08:25,872 CHILDREN IS BECAUSE THEY ASSUME 268 00:08:25,938 --> 00:08:26,505 THE CHILDREN ARE GOING TO ENJOY 269 00:08:26,572 --> 00:08:28,341 IT. AND SO THE RISKS OF THOSE 270 00:08:28,407 --> 00:08:30,743 SORTS OF ACTIVITIES, ACTIVITIES 271 00:08:30,810 --> 00:08:31,310 THAT BENEFIT PARTICIPANTS, 272 00:08:31,377 --> 00:08:32,845 DON'T SEEM LIKE A GOOD STANDARD 273 00:08:32,912 --> 00:08:35,715 FOR DETERMINING WHICH RISKS ARE 274 00:08:35,781 --> 00:08:38,150 ACCEPTABLE IN THE CONTEXT OF 275 00:08:38,217 --> 00:08:40,987 NET RISK PEDIATRIC RESEARCH. 276 00:08:41,053 --> 00:08:41,587 NAMELY RESEARCH THAT DOES NOT 277 00:08:41,654 --> 00:08:42,922 BENEFIT THE PARTICIPANTS. 278 00:08:42,989 --> 00:08:43,522 MY RESPONSE AND THIS IS WHAT I 279 00:08:43,589 --> 00:08:45,892 CALL THE "CHARITABLE" 280 00:08:45,958 --> 00:08:50,263 PARTICIPATION STANDARD. 281 00:08:50,329 --> 00:08:50,897 INSTEAD OF COMPARING THE RISKS 282 00:08:50,963 --> 00:08:51,497 OF PEDIATRIC RESEARCH TO ANY 283 00:08:51,564 --> 00:08:54,000 RISKS THAT CHILDREN FACE IN 284 00:08:54,066 --> 00:08:59,138 DAILY LIFE, WE SHOULD INSTEAD 285 00:08:59,205 --> 00:08:59,772 MORE NARROWLY COMPARE THE RISK 286 00:08:59,839 --> 00:09:02,041 OF RESEARCH COMPARED TO 287 00:09:02,108 --> 00:09:02,675 ACTIVITIES DESIGNED BY OTHERS. 288 00:09:02,742 --> 00:09:04,977 OBVIOUS EXAMPLES LIKE CHARITY 289 00:09:05,044 --> 00:09:07,280 CARWASH, CHARITY SPORTING 290 00:09:07,346 --> 00:09:12,885 EVENTS, SHOVELING A NEIGHBOR'S 291 00:09:12,952 --> 00:09:13,519 SIDEWALK, TAKING A NEIGHBOR TO 292 00:09:13,586 --> 00:09:14,086 THE HOSPITAL OR TAKING YOUR 293 00:09:14,153 --> 00:09:14,754 NEIGHBOR TO THE GROCERY STORE 294 00:09:14,820 --> 00:09:17,089 OR ACTIVITIES THAT ARE INTENDED 295 00:09:17,156 --> 00:09:19,225 TO BENEFIT SOMEBODY ELSE. AND 296 00:09:19,292 --> 00:09:21,560 POSE AT LEAST SOME BURDENS AND 297 00:09:21,627 --> 00:09:23,362 RISKS ON MINORS WHEN THEY ARE 298 00:09:23,429 --> 00:09:26,799 INVOLVED IN THAT. 299 00:09:26,866 --> 00:09:27,400 THE THOUGHT IS THAT IS A BETTER 300 00:09:27,466 --> 00:09:28,701 WAY FOR ASSESSING THE RISKS OF 301 00:09:28,768 --> 00:09:30,703 NET RISK PEDIATRIC RESEARCH. 302 00:09:30,770 --> 00:09:32,672 THAT RAISES THE QUESTION. WHEN 303 00:09:32,738 --> 00:09:35,675 I FIRST STARTED WORKING IN 304 00:09:35,741 --> 00:09:36,309 THIS, A LOT OF PEOPLE OBJECTED 305 00:09:36,375 --> 00:09:38,511 THAT THE RISKS OF RESEARCH WERE 306 00:09:38,577 --> 00:09:39,045 COMPLETELY DIFFERENT THAN 307 00:09:39,111 --> 00:09:39,712 CHARITABLE ACTIVITIES. AND WE 308 00:09:39,779 --> 00:09:42,581 CANNOT COMPARE THEM. WITH A 309 00:09:42,648 --> 00:09:43,249 NUMBER OF STUDIES TO SEE 310 00:09:43,316 --> 00:09:48,287 WHETHER OR NOT PARENTS AND 311 00:09:48,354 --> 00:09:48,888 ADOLESCENTS AGREED WITH THAT 312 00:09:48,955 --> 00:09:50,289 VIEW AND WHAT THEY THINK OF THE 313 00:09:50,356 --> 00:09:50,890 RISKS OF RESEARCH VERSUS THE 314 00:09:50,957 --> 00:09:53,326 RISK OF CHARITABLE ACTIVITIES. 315 00:09:53,392 --> 00:09:53,893 HERE IS A LITTLE BIT OF DATA 316 00:09:53,960 --> 00:09:55,394 FROM ONE OF THOSE STUDIES. AND 317 00:09:55,461 --> 00:09:57,263 WHAT IS INTERESTING ABOUT THIS, 318 00:09:57,330 --> 00:09:58,097 WHAT IT SHOWS IS FOR THE 319 00:09:58,164 --> 00:10:02,601 PARENTS, IF YOU LOOK AT THE 320 00:10:02,668 --> 00:10:05,805 FAR-RIGHT COLUMN, WHAT PARENTS 321 00:10:05,871 --> 00:10:06,405 CARE ABOUT IS THEY CARE ABOUT 322 00:10:06,472 --> 00:10:08,674 THE RISKS THEIR KIDS FACE NOT 323 00:10:08,741 --> 00:10:11,143 TO WORRY ABOUT THE CONTEXT. WE 324 00:10:11,210 --> 00:10:11,711 ASKED THEM HOW DO YOU FEEL 325 00:10:11,777 --> 00:10:13,679 ABOUT YOUR CHILDREN FACING A 326 00:10:13,746 --> 00:10:14,981 GIVEN RISK IN A RESEARCH STUDY, 327 00:10:15,047 --> 00:10:19,185 VERSUS FACING THE SAME RISK IN 328 00:10:19,251 --> 00:10:19,752 A CHARITABLE ACTIVITY, THE 329 00:10:19,819 --> 00:10:20,886 PARENTS WERE BASICALLY 330 00:10:20,953 --> 00:10:26,859 INDIFFERENT FOR THE MOST PART. 331 00:10:26,926 --> 00:10:27,493 ALMOST 90% WERE EQUALLY WILLING 332 00:10:27,560 --> 00:10:29,261 IN THE TWO CASES. THEY DON'T 333 00:10:29,328 --> 00:10:33,699 SEE ETHICAL DIFFERENCES BETWEEN 334 00:10:33,766 --> 00:10:35,468 CHARITABLE ACTIVITIES AND 335 00:10:35,534 --> 00:10:40,740 RESEARCHER ACTIVITIES. WHAT IS 336 00:10:40,806 --> 00:10:44,143 INTERESTING IS THE ONES THAT 337 00:10:44,210 --> 00:10:50,683 HAD A DIFFERENT VIEW. IT 338 00:10:50,750 --> 00:10:52,184 SUGGESTED THAT TEENS AND 339 00:10:52,251 --> 00:10:52,752 PARENTS DON'T REGARD THESE 340 00:10:52,818 --> 00:10:54,353 RISKS DRAMATICALLY DIFFERENT IN 341 00:10:54,420 --> 00:10:56,622 AN ETHICAL SENSE AND SUGGESTS 342 00:10:56,689 --> 00:11:02,595 THAT THE RISK OF CHARITABLE 343 00:11:02,661 --> 00:11:04,096 ACTIVITIES CAN COMPARE A WAY TO 344 00:11:04,163 --> 00:11:05,831 PROPERLY ASSESS THESE PEDIATRIC 345 00:11:05,898 --> 00:11:11,037 RISKS. 346 00:11:11,103 --> 00:11:11,604 THIS WAS A SHOCK FROM ONE OF 347 00:11:11,670 --> 00:11:14,807 OUR PREVIOUS FELLOWS. WE WERE 348 00:11:14,874 --> 00:11:15,274 LOOKING TO SEE WHAT A 349 00:11:15,341 --> 00:11:15,908 REPRESENTATIVE SAMPLE OF THE US 350 00:11:15,975 --> 00:11:18,010 PUBLIC THINGS ABOUT VARIOUS 351 00:11:18,077 --> 00:11:18,611 ASPECTS OF NET RISK PEDIATRIC 352 00:11:18,677 --> 00:11:21,914 RESEARCH. BASICALLY WHAT WE 353 00:11:21,981 --> 00:11:23,716 DID IS WE GAVE THEM A NUMBER OF 354 00:11:23,783 --> 00:11:24,884 DIFFERENT PROCEDURES THAT MIGHT 355 00:11:24,950 --> 00:11:27,920 BE DONE IN A NET RISK PEDIATRIC 356 00:11:27,987 --> 00:11:31,524 RESEARCH SETTING AND WE ASK 357 00:11:31,590 --> 00:11:32,124 THEM WHAT THEY THOUGHT OF THE 358 00:11:32,191 --> 00:11:32,658 APPROPRIATENESS OF THOSE 359 00:11:32,725 --> 00:11:34,293 PROCEDURES. AND WHAT WE FOUND 360 00:11:34,360 --> 00:11:38,230 WAS VERY HIGH, MID EIGHTIES, 361 00:11:38,297 --> 00:11:40,699 LOW NINETIES SUPPORT TO NET 362 00:11:40,766 --> 00:11:44,703 RISK PEDIATRIC RESEARCH. NOT 363 00:11:44,770 --> 00:11:45,304 SURPRISINGLY THE SUPPORT WENT 364 00:11:45,371 --> 00:11:45,938 DOWN A LITTLE BIT AS THE RISKS 365 00:11:46,005 --> 00:11:46,338 WENT UP. 366 00:11:46,405 --> 00:11:48,574 BUT ALSO INTERESTINGLY, AND 367 00:11:48,641 --> 00:11:50,309 THIS IS SOMETHING THAT THE US 368 00:11:50,376 --> 00:11:50,910 REGS REALLY DON'T ACCOUNT FOR 369 00:11:50,976 --> 00:11:53,179 IN THE WAY WE THINK IS 370 00:11:53,245 --> 00:11:53,813 APPROPRIATE AND THIS WAS ONE OF 371 00:11:53,879 --> 00:11:58,951 THEIR POINTS THAT WILL WAS VERY 372 00:11:59,018 --> 00:12:01,320 INTERESTED IN THIS RESEARCH 373 00:12:01,387 --> 00:12:01,954 WHICH. ACCORDING TO A SAMPLE OF 374 00:12:02,021 --> 00:12:06,625 THIS THEY FELT THAT HIGHER 375 00:12:06,692 --> 00:12:07,193 RISKS, FOR EXAMPLE SOMEWHAT 376 00:12:07,259 --> 00:12:07,793 HIGHER THAN A MINOR INCREASE 377 00:12:07,860 --> 00:12:11,997 OVER A MINIMAL RISK, CAN BE 378 00:12:12,064 --> 00:12:12,598 ACCEPTABLE IN CASES WHERE THE 379 00:12:12,665 --> 00:12:13,232 RESEARCH HAD AN ESPECIALLY HIGH 380 00:12:13,299 --> 00:12:14,333 SOCIAL VALUE. 381 00:12:14,400 --> 00:12:16,602 THE POINT IS THAT ONE, THE US 382 00:12:16,669 --> 00:12:17,203 PUBLIC IS SUPPORTIVE OF THIS 383 00:12:17,269 --> 00:12:20,739 TYPE OF RESEARCH. THE SECOND 384 00:12:20,806 --> 00:12:23,242 THING IS TO NOTE THAT THERE IS 385 00:12:23,309 --> 00:12:24,643 A GREAT EMPHASIS ON ENSURING 386 00:12:24,710 --> 00:12:25,244 THAT THE RESEARCH IS NOT JUST 387 00:12:25,311 --> 00:12:26,812 APPROPRIATE WITH RESPECT TO 388 00:12:26,879 --> 00:12:30,716 RISK. BUT THAT IT DOES IN FACT 389 00:12:30,783 --> 00:12:34,286 HAVE AN IMPORTANT SOCIAL VALUE. 390 00:12:34,353 --> 00:12:34,920 SOMETHING VALUABLE TO YOU WILL 391 00:12:34,987 --> 00:12:37,623 LEARN AS A RESULT OF RESEARCH. 392 00:12:37,690 --> 00:12:38,057 NOW THIS TO LEASE THE 393 00:12:38,124 --> 00:12:38,657 PHILOSOPHICAL QUESTION OF WHY 394 00:12:38,724 --> 00:12:42,528 IS IT? THIS SUGGESTS THE DATA 395 00:12:42,595 --> 00:12:50,236 THAT PEOPLE THINK THESE RISKS 396 00:12:50,302 --> 00:12:50,836 ARE ACCEPTABLE IN THE SUBWAY 397 00:12:50,903 --> 00:12:51,437 FOR ASSESSING THE RISK BUT IT 398 00:12:51,504 --> 00:12:52,037 LEAVES PHILOSOPHICAL QUESTION 399 00:12:52,104 --> 00:12:52,605 OF WHY IS IT ACCEPTABLE TO 400 00:12:52,671 --> 00:12:55,241 EXPOSURE AND RISK, EITHER IN 401 00:12:55,307 --> 00:13:00,946 RESEARCH OR ANY CHARITABLE 402 00:13:01,013 --> 00:13:01,480 ACTIVITY, TO RISK FOR THE 403 00:13:01,547 --> 00:13:02,081 BENEFIT OF OTHERS? I WON'T GO 404 00:13:02,148 --> 00:13:03,048 TO THAT HERE BUT THERE I WROTE 405 00:13:03,115 --> 00:13:03,616 AN ENTIRE BOOK ON THIS FOR 406 00:13:03,682 --> 00:13:04,250 PEOPLE WHO ARE INTERESTED HERE 407 00:13:04,316 --> 00:13:08,187 IS A REFERENCE. AND YOU CAN 408 00:13:08,254 --> 00:13:08,821 DRAMATICALLY INCREASE THE SALES 409 00:13:08,888 --> 00:13:09,421 OF BOOK JUST BY ONE PURCHASE 410 00:13:09,488 --> 00:13:13,759 FOR YOURSELF. 411 00:13:13,826 --> 00:13:14,326 THE NEXT THING IS EVALUATING 412 00:13:14,393 --> 00:13:15,127 RISKS. THAT WAS PEDIATRIC 413 00:13:15,194 --> 00:13:17,296 RESEARCH. HOW ABOUT EVALUATING 414 00:13:17,363 --> 00:13:21,800 RISKS? HOW DO WE DO THAT? 415 00:13:21,867 --> 00:13:22,368 I WOULD LIKE SOME QUOTE FROM 416 00:13:22,434 --> 00:13:23,002 THE BELMONT REPORT, AND YOU CAN 417 00:13:23,068 --> 00:13:24,069 READ THROUGH THESE BUT 418 00:13:24,136 --> 00:13:24,670 BASICALLY THIS IS THE BELMONT 419 00:13:24,737 --> 00:13:25,204 REPORT ONE OF THE GUIDING 420 00:13:25,271 --> 00:13:29,842 DOCUMENTS FOR IRBS. THE POINT 421 00:13:29,909 --> 00:13:30,442 HERE IS WHAT THEY ARE SAYING 422 00:13:30,509 --> 00:13:31,043 WHICH I THINK IS ABSOLUTELY 423 00:13:31,110 --> 00:13:33,012 RIGHT. AND I THINK WE STILL 424 00:13:33,078 --> 00:13:35,347 DON'T DO IN THE WAY WE SHOULD, 425 00:13:35,414 --> 00:13:37,316 IS THAT WE SHOULD 426 00:13:37,383 --> 00:13:38,817 SYSTEMATICALLY EVALUATE RISKS 427 00:13:38,884 --> 00:13:42,821 AND BENEFITS. WE SHOULD JUST 428 00:13:42,888 --> 00:13:43,455 NOT USE OUR INTUITIONS TO GUESS 429 00:13:43,522 --> 00:13:44,023 WHETHER OR NOT WE THINK FOR 430 00:13:44,089 --> 00:13:47,226 INSTANCE A PROCEDURE, AN MRI, A 431 00:13:47,293 --> 00:13:50,663 LUMBAR PUNCTURE. INSTEAD WHAT 432 00:13:50,729 --> 00:13:56,135 WE SHOULD DO IS REALLY EVALUATE 433 00:13:56,202 --> 00:13:57,970 THAT, IN A VERY SYSTEMATIC WAY. 434 00:13:58,037 --> 00:13:58,537 THIS IS A SERVER FROM A LONG 435 00:13:58,604 --> 00:14:02,141 TIME AGO FROM SHAH, THE FELLOW 436 00:14:02,208 --> 00:14:03,475 HERE. 437 00:14:03,542 --> 00:14:06,111 WE SURVEYED PEDIATRIC IRB 438 00:14:06,178 --> 00:14:10,950 CHAIRPERSONS. WE ASKED WHAT 439 00:14:11,016 --> 00:14:12,251 THEY THOUGHT OF THE RISK LEVEL 440 00:14:12,318 --> 00:14:14,820 WAS. THIS IS SURVEY. PEDIATRIC 441 00:14:14,887 --> 00:14:18,123 RESEARCH PROCEDURES, WHAT DID 442 00:14:18,190 --> 00:14:18,724 THEY THINK THE RISK LEVEL OF 443 00:14:18,791 --> 00:14:19,758 THOSE PROCEDURES WAS? 444 00:14:19,825 --> 00:14:21,961 IF WE LOOK AT THE MIDDLE ROW, 445 00:14:22,027 --> 00:14:25,030 ALLERGY SKIN TESTING, WHAT YOU 446 00:14:25,097 --> 00:14:25,664 GET IS FAIRLY DISMAYING. IS AN 447 00:14:25,731 --> 00:14:27,266 INCREDIBLE SPREAD. THESE ARE 448 00:14:27,333 --> 00:14:31,937 EXPERIENCED PEDIATRIC IRB 449 00:14:32,004 --> 00:14:32,538 CHAIRPERSONS, BUT THERE IS AN 450 00:14:32,605 --> 00:14:34,440 AMAZING SPREAD WHETHER THEY 451 00:14:34,506 --> 00:14:35,040 THINK ALLERGY SKIN TESTING IS 452 00:14:35,107 --> 00:14:39,211 MINIMAL. WHY IS THAT GOING ON? 453 00:14:39,278 --> 00:14:43,215 WE SPECULATE THAT IT IS BECAUSE 454 00:14:43,282 --> 00:14:45,851 WHAT IRB CHAIRPERSONS AND 455 00:14:45,918 --> 00:14:46,418 OTHERS ARE DOING WHEN THEY 456 00:14:46,485 --> 00:14:48,821 EVALUATE THE RISKS OF PEDIATRIC 457 00:14:48,887 --> 00:14:49,455 RESEARCH ISN'T WHAT THE BELMONT 458 00:14:49,521 --> 00:14:52,424 REPORT SUGGESTED. IT IS NOT 459 00:14:52,491 --> 00:14:53,025 DOING IT IN A SYSTEMATIC WAY 460 00:14:53,092 --> 00:14:54,460 DRIVEN BY DATA. INSTEAD IT IS 461 00:14:54,526 --> 00:14:57,196 RELYING ON INTUITIONS. AND 462 00:14:57,263 --> 00:14:57,730 UNFORTUNATELY PEOPLE HAVE 463 00:14:57,796 --> 00:14:59,531 DIFFERENT INTUITIONS. I GUESS 464 00:14:59,598 --> 00:15:00,065 NOT SURPRISINGLY ON THESE 465 00:15:00,132 --> 00:15:01,700 THINGS. 466 00:15:01,767 --> 00:15:02,268 THAT IS NOT GOING TO GET IS 467 00:15:02,334 --> 00:15:07,172 VERY FAR. WHAT WE NEED TO DO? 468 00:15:07,239 --> 00:15:07,773 I THINK IT STARTS WITH COMING 469 00:15:07,840 --> 00:15:08,907 BACK TO THE DEFINITION. 470 00:15:08,974 --> 00:15:09,541 HOPEFULLY EVERYBODY'S FAMILIAR 471 00:15:09,608 --> 00:15:11,010 WITH THIS. THIS IS THE 472 00:15:11,076 --> 00:15:11,577 DEFINITION FROM THE FEDERAL 473 00:15:11,644 --> 00:15:15,047 REGS OF MINIMAL RISK. 474 00:15:15,114 --> 00:15:15,547 I THINK WE NEED TO DO TWO 475 00:15:15,614 --> 00:15:17,483 THINGS. FIRST WE NEED TO 476 00:15:17,549 --> 00:15:19,351 UNDERSTAND THE DEFINITION. AND 477 00:15:19,418 --> 00:15:22,921 SECOND IS, FIGURING OUT A WAY 478 00:15:22,988 --> 00:15:25,090 TO IMPLEMENT IT SYSTEMATICALLY. 479 00:15:25,157 --> 00:15:25,658 TO AT LEAST APPROACH THE 480 00:15:25,724 --> 00:15:27,526 BELMONT IDEAL. 481 00:15:27,593 --> 00:15:31,030 SO TWO MISINTERPRETATIONS THAT 482 00:15:31,096 --> 00:15:32,331 I HAVE ENCOUNTERED A LOT OVER 483 00:15:32,398 --> 00:15:38,237 THE YEARS. THE FIRST IS THAT 484 00:15:38,304 --> 00:15:38,871 WHAT SOME PEOPLE THINK THAT THE 485 00:15:38,937 --> 00:15:42,474 MINIMAL RISK DEFINITION IS IS 486 00:15:42,541 --> 00:15:43,008 YOU ASSESS WHETHER OR NOT 487 00:15:43,075 --> 00:15:43,809 CHILDREN ORDINARILY ENCOUNTER 488 00:15:43,876 --> 00:15:44,443 THE SPECIFIC PROCEDURE IN DAILY 489 00:15:44,510 --> 00:15:47,513 LIFE. AND IF THEY DON'T THAT 490 00:15:47,579 --> 00:15:48,113 PROCEDURE QUALIFIES IS MORE 491 00:15:48,180 --> 00:15:56,622 THAN MINIMAL RISK. 492 00:15:56,689 --> 00:15:57,189 I KNOW PEOPLE KNOW REIKI. BUT 493 00:15:57,256 --> 00:15:57,790 THIS IS A TECHNIQUE WHERE YOU 494 00:15:57,856 --> 00:15:58,424 BASICALLY PUT YOUR HANDS ABOVE 495 00:15:58,490 --> 00:15:58,991 THE BODY OF THE PATIENT AND 496 00:15:59,058 --> 00:16:01,894 YOU'RE SUPPOSED TO TRY TO 497 00:16:01,960 --> 00:16:02,461 TRANSMIT POSITIVE ENERGY TO 498 00:16:02,528 --> 00:16:02,961 THEM, AND SUBTRACT SOME 499 00:16:03,028 --> 00:16:06,198 NEGATIVE ENERGY FROM THEM. AND 500 00:16:06,265 --> 00:16:06,699 I THINK IF ANY RESEARCH 501 00:16:06,765 --> 00:16:07,399 PROCEDURE QUALIFIES AS MINIMAL 502 00:16:07,466 --> 00:16:09,968 RISK, THIS ONE CERTAINLY DOES. 503 00:16:10,035 --> 00:16:10,602 I CANNOT SEE HOW THERE ARE ANY 504 00:16:10,669 --> 00:16:13,238 RISKS AT ALL. BUT IT IS NOT A 505 00:16:13,305 --> 00:16:13,739 PROCEDURE THE CHILDREN 506 00:16:13,806 --> 00:16:14,440 ORDINARILY ENCOUNTER IN THEIR 507 00:16:14,506 --> 00:16:18,043 LIVES. BUT IT WOULD BE A 508 00:16:18,110 --> 00:16:18,644 MISTAKE THAT A STUDY OF REIKI 509 00:16:18,711 --> 00:16:19,378 IS MORE THAN MINIMAL RISK. 510 00:16:19,445 --> 00:16:24,083 HOW DO WE AVOID THAT? GOING 511 00:16:24,149 --> 00:16:24,650 BACK TO THE DEFINITION AND 512 00:16:24,717 --> 00:16:26,585 COMPARING THE LEVEL OF THE 513 00:16:26,652 --> 00:16:28,087 PROBABLY OF MAGNITUDE AND HARM 514 00:16:28,153 --> 00:16:33,592 TO THE LEVEL OF THE RISKS OF 515 00:16:33,659 --> 00:16:34,226 DAILY LIFE SO IT IS NOT A TYPE 516 00:16:34,293 --> 00:16:34,827 OF PROCEDURE BUT THE LEVEL OF 517 00:16:34,893 --> 00:16:35,427 THE RISKS THAT IS SUPPOSED TO 518 00:16:35,494 --> 00:16:36,028 BE GETTING COMPARED. 519 00:16:36,095 --> 00:16:40,733 ANOTHER MISINTERPRETATION. I 520 00:16:40,799 --> 00:16:41,367 THINK SOME PEOPLE WHEN THEY TRY 521 00:16:41,433 --> 00:16:41,900 TO IMPLEMENT THE MINIMAL 522 00:16:41,967 --> 00:16:43,168 STANDARD THEY ASK THEMSELVES, 523 00:16:43,235 --> 00:16:43,669 IS THERE ANY CHANCE OF 524 00:16:43,736 --> 00:16:45,137 SIGNIFICANT HARM? I THINK THAT 525 00:16:45,204 --> 00:16:48,607 IS ALSO A MISTAKE. 526 00:16:48,674 --> 00:16:50,809 THE FACT THAT THERE IS ANY 527 00:16:50,876 --> 00:16:51,410 CHANCE OF HARM DOES NOT MEAN 528 00:16:51,477 --> 00:16:52,010 THAT A PROCEDURE IS MORE THAN 529 00:16:52,077 --> 00:16:55,180 THE RISK. IT DEPENDS ON HOW 530 00:16:55,247 --> 00:17:00,319 LIKELY THAT IS. SOMETHING OF 531 00:17:00,386 --> 00:17:00,786 HAVING THE CHANCE OF 532 00:17:00,853 --> 00:17:01,387 SIGNIFICANTLY HARM, AND STILL 533 00:17:01,453 --> 00:17:01,954 BE MINIMAL RISK IS IF THAT 534 00:17:02,020 --> 00:17:04,590 CHANCE IS MINIMALLY LOW. AND WE 535 00:17:04,656 --> 00:17:07,025 CAN TALK ABOUT THAT MORE PEOPLE 536 00:17:07,092 --> 00:17:07,526 ARE INTERESTED. 537 00:17:07,593 --> 00:17:07,893 THOSE ARE THE TWO 538 00:17:07,960 --> 00:17:08,494 MISINTERPRETATIONS. TRYING TO 539 00:17:08,560 --> 00:17:09,061 UNDERSTAND THE DEFINITION 540 00:17:09,128 --> 00:17:11,797 FIRST. 541 00:17:11,864 --> 00:17:12,331 AND THE SECOND THING THAT I 542 00:17:12,398 --> 00:17:14,833 WILL MENTION IS BRIEFLY, WHAT 543 00:17:14,900 --> 00:17:15,934 WE NEED THEN IS METHODS FOR 544 00:17:16,001 --> 00:17:18,570 COMPARING THEM. FOR ACTUALLY 545 00:17:18,637 --> 00:17:20,005 IMPLEMENTING THE DEFINITION. 546 00:17:20,072 --> 00:17:23,275 AND THAT REQUIRES THREE THINGS. 547 00:17:23,342 --> 00:17:23,909 IT REQUIRES DATA ON THE RISKS 548 00:17:23,976 --> 00:17:25,544 OF THE RESEARCH PROCEDURE. FOR 549 00:17:25,611 --> 00:17:28,380 INSTANCE AN MRI, IF IT IS AN IV 550 00:17:28,447 --> 00:17:32,985 GLUCOSE TOLERANCE TEST, A 551 00:17:33,051 --> 00:17:37,022 LUMBAR PUNCTURE, DATA ON THE 552 00:17:37,089 --> 00:17:40,192 RISKS OF CHARITABLE ACTIVITIES 553 00:17:40,259 --> 00:17:40,726 AND A WAY FOR SYSTEMATIC 554 00:17:40,793 --> 00:17:45,564 EVALUATION OF RESEARCH RISKS. 555 00:17:45,631 --> 00:17:46,165 THIS IS A METHOD THAT WE HAVE 556 00:17:46,231 --> 00:17:46,698 COME UP TRYING TO DO THAT 557 00:17:46,765 --> 00:17:50,636 COMPARISON. 558 00:17:50,702 --> 00:17:52,471 WORKING ON THIS A LITTLE BIT 559 00:17:52,538 --> 00:17:53,105 COMPLICATED BUT THE POINT IS TO 560 00:17:53,172 --> 00:17:53,639 SUGGEST THAT AT LEAST IN 561 00:17:53,705 --> 00:17:54,640 PRINCIPLE THERE ALWAYS TO GET 562 00:17:54,706 --> 00:17:55,374 CLOSER TO WHAT BELMONT IS 563 00:17:55,441 --> 00:17:58,177 DIRECTING IRBS TO DO. 564 00:17:58,243 --> 00:18:07,019 HOW ABOUT PEDIATRIC ASSENT? AS 565 00:18:07,085 --> 00:18:07,653 PEOPLE ARE PROBABLY AWARE OF US 566 00:18:07,719 --> 00:18:08,120 RELATIONS REQUIRE THE 567 00:18:08,187 --> 00:18:11,857 AFFIRMATIVE AGREEMENT, THE 568 00:18:11,924 --> 00:18:12,491 ASSENT, PROVIDING THAT CHILDREN 569 00:18:12,558 --> 00:18:15,327 ARE CAPABLE OF PROVIDING IT. 570 00:18:15,394 --> 00:18:19,865 AND WHAT THE REGS GIVES US, IS 571 00:18:19,932 --> 00:18:23,469 CAPABLE IS THIS: AGE, MATURITY 572 00:18:23,535 --> 00:18:27,039 AND PSYCHOLOGICAL STATE OF THE 573 00:18:27,105 --> 00:18:27,606 CHILDREN. 574 00:18:27,673 --> 00:18:28,173 A LITTLE BIT BUT NOT TERRIBLY 575 00:18:28,240 --> 00:18:30,542 HELPFUL. HOW DO PEOPLE 576 00:18:30,609 --> 00:18:31,043 IMPLEMENT THIS? 577 00:18:31,109 --> 00:18:31,610 A LOT OF PEOPLE DO WHAT SOME 578 00:18:31,677 --> 00:18:33,145 PEOPLE REFER TO AS A RULE OF 579 00:18:33,212 --> 00:18:35,514 SEVENS. THE IDEA IS THAT AT 580 00:18:35,581 --> 00:18:38,951 THE AGE OF 7, CHILDREN BECOME 581 00:18:39,017 --> 00:18:41,820 CAPABLE OF ASSENT. THIS RULE 582 00:18:41,887 --> 00:18:44,890 OF 7S, LOOKS LIKE IT TRACES TO 583 00:18:44,957 --> 00:18:47,192 ENGLISH COMMON LAW AND THE 584 00:18:47,259 --> 00:18:55,133 1300-1400S. I SAW A REFERENCE 585 00:18:55,200 --> 00:18:55,767 THAT IT MIGHT GO BACK TO MIDDLE 586 00:18:55,834 --> 00:18:56,301 EASTERN LAW, HUNDREDS AND 587 00:18:56,368 --> 00:18:58,470 HUNDREDS YEARS BEFORE THAT. 588 00:18:58,537 --> 00:18:59,071 LOOK LIKE A VERY OLD IDEA BUT 589 00:18:59,137 --> 00:18:59,671 NOT SURE IT GIVES US WHAT WE 590 00:18:59,738 --> 00:19:01,406 WANT. 591 00:19:01,473 --> 00:19:09,715 US COG, THE ONCOLOGY GROUP, 592 00:19:09,781 --> 00:19:10,282 THEY SUGGEST NOT SEVEN BUT 593 00:19:10,349 --> 00:19:11,717 INCREASED TO NINE. WE HAVE TO 594 00:19:11,783 --> 00:19:15,220 FIGURE OUT WHEN IT IS 595 00:19:15,287 --> 00:19:15,787 APPROPRIATE AND WHAT WE ARE 596 00:19:15,854 --> 00:19:17,022 GETTING ASSENT FROM CHILDREN 597 00:19:17,089 --> 00:19:19,258 AND HERE'S SOME DATA FROM A 598 00:19:19,324 --> 00:19:19,858 LONG TIME AGO FROM US. WHICH 599 00:19:19,925 --> 00:19:23,795 SUGGESTED THAT HALF OF IRBS 600 00:19:23,862 --> 00:19:24,396 NEEDED OPTIMIST IS TO DECIDE 601 00:19:24,463 --> 00:19:24,997 WHETHER OR NOT A GIVEN CHILD 602 00:19:25,063 --> 00:19:29,067 CAN ASSENT OR NOT. 603 00:19:29,134 --> 00:19:30,035 OTHERS PICK IN AGE CUT OFF. AND 604 00:19:30,102 --> 00:19:30,836 AS YOU CAN SEE HERE THAT VARIES 605 00:19:30,903 --> 00:19:32,638 ANYWHERE FROM 7, SOME ACTUALLY 606 00:19:32,704 --> 00:19:36,775 USE 5, SOME UP TO 14. IT 607 00:19:36,842 --> 00:19:41,380 VARIES FAIRLY WIDELY. 608 00:19:41,446 --> 00:19:45,751 SO HERE'S OUR THOUGHT. WHAT YOU 609 00:19:45,817 --> 00:19:46,885 SHOULDN'T DO IT SHOULDN'T ASK 610 00:19:46,952 --> 00:19:47,486 CHILDREN TO MAKE DECISIONS 611 00:19:47,553 --> 00:19:48,921 THEY DON'T UNDERSTAND. THAT IS 612 00:19:48,987 --> 00:19:55,460 NOT PROBLEMATIC. IT IS A 613 00:19:55,527 --> 00:19:56,428 MATTER OF RESPECT INCREASES THE 614 00:19:56,495 --> 00:20:00,098 CHANCES OF BAD RESEARCH. 615 00:20:00,165 --> 00:20:00,699 WE SHOULD BE ASKING CHILDREN AT 616 00:20:00,766 --> 00:20:03,402 THE POINT IN WHICH THEY CAN 617 00:20:03,468 --> 00:20:03,936 UNDERSTAND THE BASICS OF 618 00:20:04,002 --> 00:20:05,170 RESEARCH AND THERE IS A FAIR 619 00:20:05,237 --> 00:20:10,475 AMOUNT OF DATA, MAYBE NOT 620 00:20:10,542 --> 00:20:11,076 ENOUGH, TO SUGGEST THAT MAYBE 621 00:20:11,143 --> 00:20:11,643 THAT AGE IS PROBABLY AROUND 622 00:20:11,710 --> 00:20:16,014 SOMEWHERE BETWEEN 12 AND 14. 623 00:20:16,081 --> 00:20:17,983 AND THIS IS WHERE MY VIEW 624 00:20:18,050 --> 00:20:18,584 DIVERGES A FAIR AMOUNT FROM 625 00:20:18,650 --> 00:20:23,622 CONSENSUS. 626 00:20:23,689 --> 00:20:24,122 MOST PEOPLE IN PEDIATRIC 627 00:20:24,189 --> 00:20:24,723 RESEARCH ETHICS IF THEY WERE 628 00:20:24,790 --> 00:20:25,223 GIVEN A TALK THEY WOULD 629 00:20:25,290 --> 00:20:25,891 RECOMMEND A MUCH LOWER AGE THAN 630 00:20:25,958 --> 00:20:26,525 THAT. BUT IF YOU THINK WHILE WE 631 00:20:26,592 --> 00:20:31,063 ARE ASKING FOR THIS, IT MIGHT 632 00:20:31,129 --> 00:20:34,733 SUGGEST A HIGHER ONE. 633 00:20:34,800 --> 00:20:35,300 ONE PROBLEM WITH THIS IS THAT 634 00:20:35,367 --> 00:20:35,934 IN A LOT OF CASES WHERE THE US 635 00:20:36,001 --> 00:20:37,102 REGULATIONS DO, AND I ALSO 636 00:20:37,169 --> 00:20:38,303 THINK IRBS SOMETIMES FALL INTO 637 00:20:38,370 --> 00:20:43,175 THIS TRAP TOO, IS A TETHER 638 00:20:43,241 --> 00:20:48,380 TOGETHER INFORMING INDIVIDUALS 639 00:20:48,447 --> 00:20:48,947 ABOUT A STUDY AND OBTAINING 640 00:20:49,014 --> 00:20:49,548 THEIR AGREEMENT. THE IDEA IS 641 00:20:49,615 --> 00:20:51,216 THAT WE ONLY INFORM PEOPLE 642 00:20:51,283 --> 00:20:51,750 ABOUT THEIR AGREEMENT AND 643 00:20:51,817 --> 00:20:52,618 INFORMED ABOUT THE THINGS WE 644 00:20:52,684 --> 00:20:53,852 WANT THEIR AGREEMENT FOR. 645 00:20:53,919 --> 00:20:57,856 HERE IS ONE OF MY "OTHER" 646 00:20:57,923 --> 00:20:58,490 DRUMS, I'M GOING TO BEAT FOR A 647 00:20:58,557 --> 00:21:01,927 SECOND. ONE RESULT OF THIS IF 648 00:21:01,994 --> 00:21:02,995 YOU LOOK AT THE INFORMED 649 00:21:03,061 --> 00:21:05,764 CONSENT FORMS, WE ALL BEMOAN 650 00:21:05,831 --> 00:21:07,499 THIS, BUT THEY ARE LONG AND 651 00:21:07,566 --> 00:21:08,133 INCLUDE JUST COPIOUS AMOUNTS OF 652 00:21:08,200 --> 00:21:17,442 INFORMATION. AND THEY INCLUDE I 653 00:21:17,509 --> 00:21:18,076 THINK A LOT OF INFORMATION THAT 654 00:21:18,143 --> 00:21:21,380 JUST ISN'T RELEVANT FOR THE 655 00:21:21,446 --> 00:21:22,748 CONSENT FORM, WHICH IS WHETHER 656 00:21:22,814 --> 00:21:23,248 OR NOT PEOPLE SHOULD BE 657 00:21:23,315 --> 00:21:24,916 ENROLLED IN A TRIAL. 658 00:21:24,983 --> 00:21:25,517 ON TUESDAY AT 2 PM YOU HAVE TO 659 00:21:25,584 --> 00:21:29,321 SHOW UP. BUT ON WEDNESDAYS IT 660 00:21:29,388 --> 00:21:31,390 IS A 3. EVERY OTHER FRIDAY WE 661 00:21:31,456 --> 00:21:31,990 TAKE OFF AND SO WE KNOW THOSE 662 00:21:32,057 --> 00:21:32,591 ARE IMPORTANT THINGS THAT ARE 663 00:21:32,658 --> 00:21:33,158 IMPORTANT FOR PEOPLE IN THE 664 00:21:33,225 --> 00:21:34,159 TRIAL TO KNOW. BUT IN MOST 665 00:21:34,226 --> 00:21:35,927 CASES IT IS NOT RELEVANT. IT 666 00:21:35,994 --> 00:21:37,496 MAY BE DISTRACTING FOR PEOPLE 667 00:21:37,562 --> 00:21:39,297 TO BE GIVEN THAT INFORMATION IN 668 00:21:39,364 --> 00:21:40,866 A CONSENT FORM WHEN THEY ARE 669 00:21:40,932 --> 00:21:42,100 TRYING TO DECIDE WHETHER TO 670 00:21:42,167 --> 00:21:43,468 ENROLL IN THE FIRST PLACE. AND 671 00:21:43,535 --> 00:21:47,539 ASKED THINK HE'S TIED TOGETHER 672 00:21:47,606 --> 00:21:48,507 OF INFORMING PEOPLE CAUSES A 673 00:21:48,573 --> 00:21:51,176 PROBLEM THERE. 674 00:21:51,243 --> 00:21:52,310 THE OTHER THING IS I AM SAYING 675 00:21:52,377 --> 00:21:54,279 WE SHOULD NOT OBTAIN ASSENT 676 00:21:54,346 --> 00:21:57,015 UNTIL THE CHILD IS 12-14. SO 677 00:21:57,082 --> 00:22:01,820 IF THE CHILD IS 5, 6, 7, 8, WE 678 00:22:01,887 --> 00:22:02,888 SHOULD NOT TELL THEM ABOUT THE 679 00:22:02,954 --> 00:22:05,023 RESEARCH? THAT IS PROBLEMATIC. 680 00:22:05,090 --> 00:22:05,524 IT SHOULD NOT HAVE THAT 681 00:22:05,590 --> 00:22:08,694 IMPLICATION. INSTEAD WHAT WE 682 00:22:08,760 --> 00:22:09,294 NEED TO DO IS TO BREAK APART 683 00:22:09,361 --> 00:22:11,430 WHAT WE WANT TO INFORM PEOPLE 684 00:22:11,496 --> 00:22:16,234 ABOUT AND WHEN WE ARE GETTING 685 00:22:16,301 --> 00:22:17,703 THERE AGREEMENT. 686 00:22:17,769 --> 00:22:20,706 HOW DO WE DO THIS? MY 687 00:22:20,772 --> 00:22:21,239 SUGGESTION IS TO PROVIDE 688 00:22:21,306 --> 00:22:21,873 AGE-APPROPRIATE INFORMATION TO 689 00:22:21,940 --> 00:22:22,474 ALL CHILDREN WHETHER YOU ARE 690 00:22:22,541 --> 00:22:25,644 GOING TO ASK FOR ASSENT OR NOT, 691 00:22:25,711 --> 00:22:31,316 WHETHER 5 OR 15. IF YOU'RE 692 00:22:31,383 --> 00:22:34,820 GOING TO ASK FOR THEIR ASSENT, 693 00:22:34,886 --> 00:22:35,487 YOU ASK IF THEY'RE WILLING TO 694 00:22:35,554 --> 00:22:38,890 PARTICIPATE. IF THEY ARE NOT 695 00:22:38,957 --> 00:22:39,991 ASSENTING, OR NOT REQUIRING 696 00:22:40,058 --> 00:22:43,161 THEIR ASSENT, YOU ARE GIVING 697 00:22:43,228 --> 00:22:47,899 THEM THE INFORMATION ASKING IF 698 00:22:47,966 --> 00:22:48,533 THERE ARE QUESTIONS OR CONCERNS 699 00:22:48,600 --> 00:22:50,602 AND IF THEY DON'T PARTICIPATE 700 00:22:50,669 --> 00:22:51,236 AND MONITOR THEM ANY QUESTIONS 701 00:22:51,303 --> 00:22:51,903 COME UP, YOU TRY TO ADDRESS 702 00:22:51,970 --> 00:22:53,105 THOSE OBJECTIONS. 703 00:22:53,171 --> 00:23:03,615 OKAY. COMPENSATION. I THINK 704 00:23:07,152 --> 00:23:07,552 PEOPLE LISTENING TO THIS 705 00:23:07,619 --> 00:23:08,220 REALIZE THAT THERE ARE A LOT OF 706 00:23:08,286 --> 00:23:08,653 CONCERNS REGARDING 707 00:23:08,720 --> 00:23:09,154 CONVERSATIONS. 708 00:23:09,221 --> 00:23:10,889 INTERESTING BECAUSE 709 00:23:10,956 --> 00:23:11,523 CONVERSATION IS ONE OF THE RARE 710 00:23:11,590 --> 00:23:13,258 PLACES I THINK WHERE 711 00:23:13,325 --> 00:23:18,296 INVESTIGATORS AND IRB MEMBERS 712 00:23:18,363 --> 00:23:18,930 TEND TO BE MORE CONCERNED THAN 713 00:23:18,997 --> 00:23:19,564 PEOPLE LIKE ME WHO DO RESEARCH 714 00:23:19,631 --> 00:23:21,833 ETHICS. PEOPLE IN OUR 715 00:23:21,900 --> 00:23:24,536 DEPARTMENT TEND TO BE FAIRLY 716 00:23:24,603 --> 00:23:26,271 SUPPORTIVE, RATHER THAN 717 00:23:26,338 --> 00:23:27,005 SUSPICIOUS OF COMPENSATING 718 00:23:27,072 --> 00:23:29,341 RESEARCH PARTICIPANTS. BUT 719 00:23:29,407 --> 00:23:30,008 HERE'S SOME EXAMPLES OF SOME OF 720 00:23:30,075 --> 00:23:34,312 THE SUSPICIONS. 721 00:23:34,379 --> 00:23:34,846 I DON'T KNOW IF PEOPLE ARE 722 00:23:34,913 --> 00:23:37,549 FAMILIAR WITH THIS. THE SECOND 723 00:23:37,616 --> 00:23:39,017 ONE IS FROM THE MARYLAND COURT 724 00:23:39,084 --> 00:23:39,618 OF APPEALS, THE HIGHEST COURT 725 00:23:39,684 --> 00:23:43,221 IN MARYLAND, IN RESPONSE TO THE 726 00:23:43,288 --> 00:23:45,791 GRIMES VERSUS KENNY KRIEGER 727 00:23:45,857 --> 00:23:46,358 INSTITUTE RELATED TO A PAIN 728 00:23:46,424 --> 00:23:48,527 STUDY THAT PEOPLE MAY KNOW 729 00:23:48,593 --> 00:23:49,161 ABOUT THAT RECEIVED A LOT OF 730 00:23:49,227 --> 00:23:51,229 ATTENTION. THEY WENT TO THIS 731 00:23:51,296 --> 00:23:51,863 COURT AND THERE WAS A LOT OF 732 00:23:51,930 --> 00:23:54,299 HUMAN CRY. AND THE COURT 733 00:23:54,366 --> 00:23:57,269 INITIALLY WAS EXTREMELY 734 00:23:57,335 --> 00:23:58,970 SKEPTICAL OF THE STUDY TO THE 735 00:23:59,037 --> 00:24:09,581 POINT OF ALMOST BEING SCATHING. 736 00:24:13,485 --> 00:24:13,919 THEY SAID THE PARENTS WERE 737 00:24:13,985 --> 00:24:15,287 RATHER IMPROPERLY ENTICED. IT 738 00:24:15,353 --> 00:24:19,457 IS A MISTAKE. BUT YOU CAN 739 00:24:19,524 --> 00:24:20,992 NOTICE HERE THAT THERE IS 740 00:24:21,059 --> 00:24:22,661 ENTICING WITH MONEY. WHAT MONEY 741 00:24:22,727 --> 00:24:23,295 IS DOING IS GETTING PARENTS TO 742 00:24:23,361 --> 00:24:25,797 DO THINGS WITH AND FOR THEIR 743 00:24:25,864 --> 00:24:34,706 CHILDREN AND TO THEIR CHILDREN 744 00:24:34,773 --> 00:24:36,808 THAT ARE IMPROPER. 745 00:24:36,875 --> 00:24:39,044 A FAIR NUMBER OF THE OBJECTIONS 746 00:24:39,110 --> 00:24:39,578 FOR PAYING FOR PEDIATRIC 747 00:24:39,644 --> 00:24:41,046 RESEARCH REFLECT NOT ONLY 748 00:24:41,112 --> 00:24:43,181 OBJECTIONS TO PAYMENT, BUT 749 00:24:43,248 --> 00:24:44,115 INSTEAD REFLECT OBJECTIONS TO 750 00:24:44,182 --> 00:24:46,585 THE RESEARCH ITSELF. AND THAT 751 00:24:46,651 --> 00:24:50,522 IS NOT SURPRISING. IF YOU DON'T 752 00:24:50,589 --> 00:24:51,156 LIKE A PARTICULAR STUDY, IF YOU 753 00:24:51,223 --> 00:24:54,993 THINK A PARTICULAR STUDY IS 754 00:24:55,060 --> 00:24:57,929 UNETHICAL OR PROBLEMATIC, 755 00:24:57,996 --> 00:24:58,563 YOU'RE NOT GOING TO LIKE PAYING 756 00:24:58,630 --> 00:24:59,064 PARENTS TO ENROLL THEIR 757 00:24:59,130 --> 00:25:01,333 CHILDREN IN THE RESEARCH. AND 758 00:25:01,399 --> 00:25:06,137 THAT IS A LEGITIMATE CONCERN. 759 00:25:06,204 --> 00:25:06,705 BUT I WANT TO DO IS FOCUS ON 760 00:25:06,771 --> 00:25:08,106 STUDIES WHERE WE THINK THAT 761 00:25:08,173 --> 00:25:08,740 THEY ARE ETHICALLY APPROPRIATE 762 00:25:08,807 --> 00:25:09,407 AND WHETHER PAYMENT IS INVOLVED 763 00:25:09,474 --> 00:25:13,278 OR NOT, OBVIOUSLY IRBS NEED AND 764 00:25:13,345 --> 00:25:16,147 THEIR CHARGES NEED TO MAKE SURE 765 00:25:16,214 --> 00:25:18,650 THAT THE RESEARCHERS REVELATORY 766 00:25:18,717 --> 00:25:19,284 AND ETHICALLY APPROPRIATE. THAT 767 00:25:19,351 --> 00:25:21,753 IT IS SOCIALLY, SCIENTIFICALLY 768 00:25:21,820 --> 00:25:22,687 VALUABLE; RIGOROUS AND VALID, 769 00:25:22,754 --> 00:25:26,725 THAT THE RISKS ARE ACCEPTABLE 770 00:25:26,791 --> 00:25:28,693 AND ASSENT IS OBTAINED WHEN IT 771 00:25:28,760 --> 00:25:30,862 SHOULD BE OBTAINED AND IT IS 772 00:25:30,929 --> 00:25:31,463 BEING RESPECTED, AND ALL THE 773 00:25:31,529 --> 00:25:32,664 OTHER REQUIREMENTS. 774 00:25:32,731 --> 00:25:34,799 AND SO THE QUESTION THEN IS, 775 00:25:34,866 --> 00:25:36,201 WHAT DO WE THINK? AND WHAT ARE 776 00:25:36,268 --> 00:25:39,838 THE ETHICS OF COMPENSATION? 777 00:25:39,905 --> 00:25:40,438 WHEN ALL OF THESE CONDITIONS 778 00:25:40,505 --> 00:25:43,942 ARE SATISFIED. 779 00:25:44,009 --> 00:25:45,777 SO, ONE WORRY I THINK IS THIS. 780 00:25:45,844 --> 00:25:48,780 WHICH IS THAT AS WE ALL KNOW, 781 00:25:48,847 --> 00:25:51,249 IRBS EVALUATE AT LEAST INITIAL 782 00:25:51,316 --> 00:25:54,786 REVIEWS AND EVALUATE RESEARCH 783 00:25:54,853 --> 00:25:57,989 PROTOCOLS PROSPECTIVELY. THE 784 00:25:58,056 --> 00:25:58,590 EVALUATE BEFORE ANY CHILDREN 785 00:25:58,657 --> 00:25:59,190 ARE INVOLVED AT ALL. HOW DO 786 00:25:59,257 --> 00:26:03,261 YOU FIGURE OUT WHAT THE RISKS 787 00:26:03,328 --> 00:26:03,862 ARE IF YOU DON'T KNOW WHO IS 788 00:26:03,929 --> 00:26:06,331 GOING TO BE ENROLLED? 789 00:26:06,398 --> 00:26:06,865 YOU LOOK AT THE INCLUSION/ 790 00:26:06,932 --> 00:26:09,901 EXCLUSION CRITERIA. YOU FIGURE 791 00:26:09,968 --> 00:26:10,535 OUT WHAT THE POPULATION IS THAT 792 00:26:10,602 --> 00:26:12,237 SATISFIES THOSE CRITERIA. AND 793 00:26:12,304 --> 00:26:12,871 YOU BASE YOUR RISK JUDGMENT ON 794 00:26:12,938 --> 00:26:15,073 THAT. 795 00:26:15,140 --> 00:26:19,044 SO, THAT IS PRESUMABLY 796 00:26:19,110 --> 00:26:19,644 ACCEPTABLE, PROBABLY IN MOST 797 00:26:19,711 --> 00:26:22,013 CASES. THE PROBLEM IS THERE 798 00:26:22,080 --> 00:26:23,882 MIGHT BE SOME CASES WHERE FOR 799 00:26:23,949 --> 00:26:25,817 SOME OF THE SPECIFIC 800 00:26:25,884 --> 00:26:26,785 INDIVIDUALS WITHIN THE 801 00:26:26,851 --> 00:26:29,521 POPULATION, THAT SATISFIES THE 802 00:26:29,587 --> 00:26:32,490 INCLUSION/ EXCLUSION CRITERIA, 803 00:26:32,557 --> 00:26:33,792 IT MIGHT BE WHAT YOU THINK OF 804 00:26:33,858 --> 00:26:36,294 IDIOSYNCRATIC CIRCUMSTANCES. 805 00:26:36,361 --> 00:26:38,997 THEY MAY HAVE A HISTORY OR 806 00:26:39,064 --> 00:26:39,631 COMORBIDITY, OR TREATMENTS THEY 807 00:26:39,698 --> 00:26:40,665 ARE TAKING OR SOMETHING ELSE IN 808 00:26:40,732 --> 00:26:42,233 THE CIRCUMSTANCES OR THE 809 00:26:42,300 --> 00:26:43,068 CONDITION OF THEIR HEALTH WHICH 810 00:26:43,134 --> 00:26:45,937 RAISES CONCERNS OR GREATER 811 00:26:46,004 --> 00:26:47,505 RISKS FOR THEM THAN OTHER 812 00:26:47,572 --> 00:26:48,139 PEOPLE WHO ARE ELIGIBLE FOR THE 813 00:26:48,206 --> 00:26:49,474 STUDY. 814 00:26:49,541 --> 00:26:52,444 AND THAT IS A POSSIBILITY, THE 815 00:26:52,510 --> 00:26:53,712 NOTHING THIS IS A CASE WHERE WE 816 00:26:53,778 --> 00:26:56,147 NEED TO START THINKING ABOUT 817 00:26:56,214 --> 00:26:57,115 INDIVIDUALIZED ASSESSMENT OF 818 00:26:57,182 --> 00:26:59,284 SPECIFIC INDIVIDUALS WHERE THE 819 00:26:59,351 --> 00:27:00,385 CHILDREN DON'T GET ENROLLED. 820 00:27:00,452 --> 00:27:02,687 UNTIL WE MAKE SURE THE RISKS 821 00:27:02,754 --> 00:27:04,956 ARE APPROPRIATE FOR THEM. 822 00:27:05,023 --> 00:27:06,558 THAT IS A WAY TO PUT OFF AT 823 00:27:06,624 --> 00:27:07,592 LEAST ONE OF THE OBJECTIONS TO 824 00:27:07,659 --> 00:27:09,794 PAYMENT. WHICH IS THERE MIGHT 825 00:27:09,861 --> 00:27:11,629 BE SPECIFIC INDIVIDUALS, EVEN 826 00:27:11,696 --> 00:27:12,130 IF THE OVERALL STUDY IS 827 00:27:12,197 --> 00:27:15,266 ACCEPTABLE. THERE MIGHT BE 828 00:27:15,333 --> 00:27:15,900 SPECIFIC INDIVIDUALS FOR WHOM 829 00:27:15,967 --> 00:27:17,035 THE STUDY IS INAPPROPRIATE. 830 00:27:17,102 --> 00:27:18,636 AND THIS IS AT LEAST ONE WAY TO 831 00:27:18,703 --> 00:27:20,538 TRY TO ADDRESS THAT. 832 00:27:20,605 --> 00:27:23,908 OKAY SO NOW WE ARE SUPPOSED TO 833 00:27:23,975 --> 00:27:24,476 IMAGINE WE HAVE DONE ALL OF 834 00:27:24,542 --> 00:27:24,976 THAT AND WE ARE FAIRLY 835 00:27:25,043 --> 00:27:29,581 CONFIDENT THAT THE STUDY IS 836 00:27:29,647 --> 00:27:31,216 ACCEPTABLE ACCORDING TO ETHICAL 837 00:27:31,282 --> 00:27:31,883 CONSIDERATIONS. 838 00:27:31,950 --> 00:27:32,417 AND THE QUESTION IS WHAT WE 839 00:27:32,484 --> 00:27:35,220 THINK ABOUT COMPENSATION OR 840 00:27:35,286 --> 00:27:38,990 PAYMENT WITHIN THAT CONTEXT FOR 841 00:27:39,057 --> 00:27:39,557 THOSE STUDIES? SO HERE'S A 842 00:27:39,624 --> 00:27:44,796 LITTLE BIT FROM THE PAPER WE 843 00:27:44,863 --> 00:27:45,397 WROTE A REALLY LONG TIME AGO 844 00:27:45,463 --> 00:27:46,931 AND PAYMENT. 845 00:27:46,998 --> 00:27:50,001 BASICALLY WHAT WE DID WAS WE 846 00:27:50,068 --> 00:27:51,403 TRIED TO DIVIDED INTO FIVE 847 00:27:51,469 --> 00:27:52,037 TYPES OF PAYMENT. REIMBURSEMENT 848 00:27:52,103 --> 00:27:54,205 FOR EXPENSES. COMPENSATION FOR 849 00:27:54,272 --> 00:27:57,008 BURDENS, RISKS, INJURY. 850 00:27:57,075 --> 00:28:00,912 APPRECIATION PAYMENT. 851 00:28:00,979 --> 00:28:01,479 INCENTIVES TO GET PEOPLE TO 852 00:28:01,546 --> 00:28:02,113 ENROLL AND GET THEM TO CONTINUE 853 00:28:02,180 --> 00:28:03,281 TO PARTICIPATE. AND ALSO 854 00:28:03,348 --> 00:28:13,091 PROFIT-SHARING. 855 00:28:13,158 --> 00:28:13,625 SO I'M GOING TO GO THROUGH 856 00:28:13,691 --> 00:28:14,192 THESE QUICKLY. THE REASON I 857 00:28:14,259 --> 00:28:15,126 HAVE THIS TYPOLOGY, IS THAT I 858 00:28:15,193 --> 00:28:15,760 AM TRYING TO CONVINCE YOU THAT 859 00:28:15,827 --> 00:28:18,930 THE ETHICAL CONSIDERATIONS VARY 860 00:28:18,997 --> 00:28:19,531 GREATLY DEPENDING ON WHICH OF 861 00:28:19,597 --> 00:28:20,165 THESE TYPES OF PAYMENT YOU'RE 862 00:28:20,231 --> 00:28:21,433 CONSIDERING. 863 00:28:21,499 --> 00:28:23,635 I'M GOING TO START FIRST WITH 864 00:28:23,701 --> 00:28:27,238 THE LAST ONE, MINIMAL BRACKET 865 00:28:27,305 --> 00:28:27,872 THAT AND PUT IT ASIDE. THIS IS 866 00:28:27,939 --> 00:28:28,673 WHERE MY VIEWS REALLY DIVERT 867 00:28:28,740 --> 00:28:31,976 FROM A LOT OF OTHER PEOPLE. I 868 00:28:32,043 --> 00:28:32,577 THINK WE REALLY NEED TO THINK 869 00:28:32,644 --> 00:28:33,044 MORE SERIOUSLY ABOUT 870 00:28:33,111 --> 00:28:40,752 PROFIT-SHARING. 871 00:28:40,819 --> 00:28:41,252 I THINK WE ALL AGREE THAT 872 00:28:41,319 --> 00:28:41,786 EXPLOITATION IS A SERIOUS 873 00:28:41,853 --> 00:28:45,323 CONCERN. CLINICAL RESEARCH. WE 874 00:28:45,390 --> 00:28:45,924 NEED TO AVOID IT PARTICULARLY 875 00:28:45,990 --> 00:28:53,131 IN THE CONTEXT WHERE PEOPLE ARE 876 00:28:53,198 --> 00:28:53,731 MAKING AN AWFUL LOT OF MONEY 877 00:28:53,798 --> 00:28:54,332 OFF OF A TRIAL. FOR HIS ABOUT 878 00:28:54,399 --> 00:28:54,799 EXPECTATIONS THAT IF 879 00:28:54,866 --> 00:28:55,400 PARTICIPANTS DON'T SHARE IN 880 00:28:55,467 --> 00:28:56,734 THOSE PROFITS AT ALL. 881 00:28:56,801 --> 00:28:58,069 AND I KNOW PEOPLE WHO SEE 882 00:28:58,136 --> 00:28:59,270 ETHICS GOING AROUND-- A LITTLE 883 00:28:59,337 --> 00:29:05,443 PLUG FOR THE ETHICS GROUND 884 00:29:05,510 --> 00:29:07,178 ROUNDS, WE DO THEN FOUR TIMES A 885 00:29:07,245 --> 00:29:07,812 YEAR, AND TWO YEARS AGO WITH A 886 00:29:07,879 --> 00:29:09,214 SESSION ON PROFIT SHARING FOR 887 00:29:09,280 --> 00:29:11,282 SAMPLE DONORS. I WAS TRYING TO 888 00:29:11,349 --> 00:29:13,985 ARGUE THAT WE SHOULD AT LEAST 889 00:29:14,052 --> 00:29:16,254 CONSIDER IT IN SOME CASES. 890 00:29:16,321 --> 00:29:21,326 SO WE COULD TALK ABOUT IT MORE. 891 00:29:21,392 --> 00:29:22,494 BUT THAT IS DEFINITELY A FAIRLY 892 00:29:22,560 --> 00:29:27,031 IDIOSYNCRATIC VIEW ON MY PART. 893 00:29:27,098 --> 00:29:27,632 FOR THE REST I'M GOING TO SET 894 00:29:27,699 --> 00:29:28,233 IT ASIDE, AND TALK ABOUT THE 895 00:29:28,299 --> 00:29:28,967 OTHER FOUR TYPES. 896 00:29:29,033 --> 00:29:33,338 SO REIMBURSEMENT COMPENSATION. 897 00:29:33,404 --> 00:29:33,972 WHAT REIMBURSEMENT COMPENSATION 898 00:29:34,038 --> 00:29:35,206 DO IS THEY REMOVE BARRIERS TO 899 00:29:35,273 --> 00:29:39,244 RESEARCH ENROLLMENT. AND ALSO 900 00:29:39,310 --> 00:29:39,711 OBVIOUSLY TO RESEARCH 901 00:29:39,777 --> 00:29:47,185 PARTICIPATION. SO THEY ADDRESS 902 00:29:47,252 --> 00:29:47,819 THE COSTS OF GETTING THERE, AND 903 00:29:47,886 --> 00:29:49,154 THE BURDENS AND INJURIES THAT 904 00:29:49,220 --> 00:29:49,687 THE PERSON HAS EXPERIENCE 905 00:29:49,754 --> 00:29:57,328 ALTHOUGH WE KNOW US REGULATIONS 906 00:29:57,395 --> 00:29:57,829 ARE NOT VERY GOOD ABOUT 907 00:29:57,896 --> 00:29:59,531 COMPENSATING PARTICIPANTS FOR 908 00:29:59,597 --> 00:30:00,165 INJURIES. OTHER COUNTRIES ARE 909 00:30:00,231 --> 00:30:03,801 BETTER. 910 00:30:03,868 --> 00:30:04,402 RESEARCH SUBJECTS SHOULD NOT BE 911 00:30:04,469 --> 00:30:08,640 THE ONES TO BEAR THE COSTS TO 912 00:30:08,706 --> 00:30:12,143 CONTRIBUTE TO THE SOCIAL GOOD. 913 00:30:12,210 --> 00:30:12,777 THE SPECIFIC INDIVIDUAL SHOULD 914 00:30:12,844 --> 00:30:13,378 NOT BE THE ONE WHO BEARS THE 915 00:30:13,444 --> 00:30:15,246 COST OF IT. THEY SHOULD NOT BE 916 00:30:15,313 --> 00:30:18,716 THE ONES WHO HAVE TO PAY TO GET 917 00:30:18,783 --> 00:30:19,317 TO THE SITE, OR THE ONES WHO 918 00:30:19,384 --> 00:30:21,553 HAVE TO PAY FOR CLINICAL CARE 919 00:30:21,619 --> 00:30:22,187 IF THEY ARE INJURED AS A RESULT 920 00:30:22,253 --> 00:30:23,555 OF BEING IN THE STUDY. 921 00:30:23,621 --> 00:30:25,857 SO THAT SUGGESTS AN ARGUMENT TO 922 00:30:25,924 --> 00:30:27,392 BE MADE WHICH I WILL MENTION 923 00:30:27,458 --> 00:30:27,959 HERE. AND THEN WE CAN TALK 924 00:30:28,026 --> 00:30:31,196 ABOUT IT MORE, IF PEOPLE WANT 925 00:30:31,262 --> 00:30:31,829 TO HEAR LITTLE BIT MORE OF THE 926 00:30:31,896 --> 00:30:35,466 ARGUMENT. REIMBURSEMENT 927 00:30:35,533 --> 00:30:38,102 COMPENSATION NOT ONLY ARE THEY 928 00:30:38,169 --> 00:30:42,941 ETHICALLY OKAY BUT ETHICALLY 929 00:30:43,007 --> 00:30:43,541 OBLIGATORY IN SOME CASES THE 930 00:30:43,608 --> 00:30:44,042 SENSE THAT IT WOULD BE 931 00:30:44,108 --> 00:30:44,676 ETHICALLY IMPROPER NOT TO OFFER 932 00:30:44,742 --> 00:30:49,347 THEM. THAT GETS US TO 933 00:30:49,414 --> 00:30:51,149 REIMBURSEMENT COMPENSATION. I 934 00:30:51,216 --> 00:30:56,187 HAVE SET PROFIT SHARING A PART. 935 00:30:56,254 --> 00:30:56,788 AN APPRECIATION AND INCENTIVES 936 00:30:56,854 --> 00:30:57,689 BOTH CAN BE LUMPED TOGETHER. 937 00:30:57,755 --> 00:31:03,928 APPRECIATION PAYMENTS ARE 938 00:31:03,995 --> 00:31:04,562 ESSENTIALLY SMALL PAYMENT ABOVE 939 00:31:04,629 --> 00:31:05,163 AND BEYOND THE COSTS THAT CAN 940 00:31:05,230 --> 00:31:11,402 ACT AS AN INTENSIVE. 941 00:31:11,469 --> 00:31:11,903 SO THE WORRY IS, WE HAVE 942 00:31:11,970 --> 00:31:16,708 REASONABLE DATA TO SHOW THIS. 943 00:31:16,774 --> 00:31:17,242 REMOVING BARRIERS TO MAKE 944 00:31:17,308 --> 00:31:20,612 PARTICIPATION COST NEUTRAL FOR 945 00:31:20,678 --> 00:31:21,212 PEOPLE, FREQUENTLY DOES NOT 946 00:31:21,279 --> 00:31:23,748 YIELD SUFFICIENT ENROLLMENT. 947 00:31:23,815 --> 00:31:24,349 REMEMBER WE ARE TALKING ABOUT 948 00:31:24,415 --> 00:31:26,818 STUDIES THAT SATISFY THE 949 00:31:26,884 --> 00:31:27,418 ETHICAL REQUIREMENTS AND THE 950 00:31:27,485 --> 00:31:30,221 REVELATORY REQUIREMENTS. ONE 951 00:31:30,288 --> 00:31:31,222 OF THOSE IN MY VIEW THAT IS 952 00:31:31,289 --> 00:31:33,191 MOST IMPORTANCE I MENTIONED IS 953 00:31:33,258 --> 00:31:33,791 THAT THE STUDY HAS IMPORTANT 954 00:31:33,858 --> 00:31:36,261 SOCIAL VALUE. 955 00:31:36,327 --> 00:31:38,263 IF HE DOES HAVE IMPORTANT 956 00:31:38,329 --> 00:31:39,264 SOCIAL VALUE, THAT GIVES 957 00:31:39,330 --> 00:31:39,897 ETHICAL REASONS IN FAVOR OF THE 958 00:31:39,964 --> 00:31:43,401 RESEARCH. ETHICAL REASONS TO 959 00:31:43,468 --> 00:31:45,136 DO THE RESEARCH, TO GET PEOPLE 960 00:31:45,203 --> 00:31:46,938 ENROLLED IN THE RESEARCH, TO 961 00:31:47,005 --> 00:31:47,538 GET THEM THROUGH THE RESEARCH 962 00:31:47,605 --> 00:31:48,940 AND TO REALIZE THE PRIMARY 963 00:31:49,007 --> 00:31:51,576 GOALS OF THE RESEARCH. 964 00:31:51,643 --> 00:31:53,745 AND SO WHAT THAT MEANS, IF WE 965 00:31:53,811 --> 00:31:54,345 ARE IN A CONTEXT WHERE WE ARE 966 00:31:54,412 --> 00:31:56,314 NOT GETTING ENOUGH PEOPLE 967 00:31:56,381 --> 00:31:58,483 SIMPLY BY REMOVING THE 968 00:31:58,549 --> 00:31:59,384 BARRIERS, THEN THERE IS 969 00:31:59,450 --> 00:32:03,154 ACTUALLY A POSITIVE, ETHICAL 970 00:32:03,221 --> 00:32:03,621 REASON TO CONSIDERING 971 00:32:03,688 --> 00:32:04,222 INCENTIVES TO THE EXTENT THAT 972 00:32:04,289 --> 00:32:05,056 IT WILL HELP PROMOTE THE GOAL 973 00:32:05,123 --> 00:32:11,863 OF GETTING THE STUDY COMPLETED. 974 00:32:11,929 --> 00:32:12,463 SO, THERE IS AN ETHICAL REASON 975 00:32:12,530 --> 00:32:13,498 TO DO THAT. THERE IS AN 976 00:32:13,564 --> 00:32:17,135 ARGUMENT FOR THAT. OBVIOUSLY 977 00:32:17,201 --> 00:32:19,203 THERE ARE STILL CONCERNS. IN 978 00:32:19,270 --> 00:32:19,837 PEDIATRIC RESEARCH, IS WHERE I 979 00:32:19,904 --> 00:32:23,207 THINK THE BIGGEST CONCERN IS. 980 00:32:23,274 --> 00:32:24,475 BECAUSE HERE WE HAVE A 981 00:32:24,542 --> 00:32:26,044 SITUATION WHERE PAYMENT BEYOND 982 00:32:26,110 --> 00:32:27,345 COSTS RAISES THE POSSIBILITY 983 00:32:27,412 --> 00:32:28,546 FOR PARENTS TO MAKE MONEY OFF 984 00:32:28,613 --> 00:32:31,049 OF CHILDREN'S ENROLLMENT. 985 00:32:31,115 --> 00:32:32,116 ALMOST EVERYBODY'S GOING TO 986 00:32:32,183 --> 00:32:38,122 AGREE. THAT IS ETHICALLY 987 00:32:38,189 --> 00:32:38,756 PROBLEMATIC FOR PARENTS MAKING 988 00:32:38,823 --> 00:32:39,290 MONEY BY ENROLLMENT THEIR 989 00:32:39,357 --> 00:32:39,991 CHILDREN IN RESEARCH. 990 00:32:40,058 --> 00:32:41,292 A COUPLE OF THINGS TO SAY ABOUT 991 00:32:41,359 --> 00:32:42,593 THAT WORRY. ONE IS AGAIN TO 992 00:32:42,660 --> 00:32:46,631 REMIND YOU, ASSUMING THAT THE 993 00:32:46,698 --> 00:32:47,699 RESEARCH IS ETHICALLY 994 00:32:47,765 --> 00:32:50,468 APPROPRIATE, AND IF THAT IS 995 00:32:50,535 --> 00:32:51,102 TRUE, THEN EVEN IF THE PARENTS 996 00:32:51,169 --> 00:32:54,238 ARE ENROLLING THEM TO MAKE THE 997 00:32:54,305 --> 00:32:54,772 MONEY, THEY ARE HOPEFULLY 998 00:32:54,839 --> 00:32:55,440 UNROLLING THE CHILDREN 999 00:32:55,506 --> 00:33:02,814 SOMETHING THAT IS APPROPRIATE. 1000 00:33:02,880 --> 00:33:04,215 IN AN APPROPRIATE ACTIVITY. 1001 00:33:04,282 --> 00:33:04,782 THAT ADDRESSES SOME OF THE 1002 00:33:04,849 --> 00:33:06,684 WORRY. 1003 00:33:06,751 --> 00:33:07,919 AND FROM WHAT WE KNOW OF HIM 1004 00:33:07,985 --> 00:33:11,055 PSYCHOLOGY, EVEN SMALL 1005 00:33:11,122 --> 00:33:11,689 INCENTIVES, THE CHANCES IMPROVE 1006 00:33:11,756 --> 00:33:14,058 TO GET THE PARENTS TO ENROLL. 1007 00:33:14,125 --> 00:33:14,659 IF THEY HAVE SPECIFIC REASON 1008 00:33:14,726 --> 00:33:17,195 THAT A TRIAL IS PARTICULARLY 1009 00:33:17,261 --> 00:33:17,829 INAPPROPRIATE FOR THE CHILDREN, 1010 00:33:17,895 --> 00:33:19,330 IT WILL GIVE THEM LITTLE 1011 00:33:19,397 --> 00:33:19,897 INCENTIVE TO ENROLL THEIR 1012 00:33:19,964 --> 00:33:22,033 CHILDREN IN THE STUDIES. IF 1013 00:33:22,100 --> 00:33:22,633 THE INCENTIVES ARE RELATIVELY 1014 00:33:22,700 --> 00:33:31,676 SMALL. SO I THINK IN THE END, 1015 00:33:31,743 --> 00:33:32,276 THE SMALL INCENTIVES DOES NOT 1016 00:33:32,343 --> 00:33:32,844 RAISES SIGNIFICANT ETHICAL 1017 00:33:32,910 --> 00:33:34,746 CONCERNS. AND THIS IS 1018 00:33:34,812 --> 00:33:35,446 REFLECTED BY THE AMERICAN 1019 00:33:35,513 --> 00:33:36,280 ACADEMY OF PEDIATRICS. AND THEY 1020 00:33:36,347 --> 00:33:40,084 HAVE SOME GUIDANCE ON THIS. 1021 00:33:40,151 --> 00:33:40,651 THE MOST RECENT ONES I COULD 1022 00:33:40,718 --> 00:33:41,285 FIND-- I WILL BE INTERESTED TO 1023 00:33:41,352 --> 00:33:43,221 KNOW IF ANYBODY KNOWS MORE 1024 00:33:43,287 --> 00:33:44,155 RECENT ONES-- BUT THE MORE 1025 00:33:44,222 --> 00:33:44,856 RECENT ONES I COULD FIND WERE 1026 00:33:44,922 --> 00:33:45,690 FROM 2010. THE EARLIER ONES 1027 00:33:45,757 --> 00:33:48,259 FROM 1995, DESCRIBED THIS AS A 1028 00:33:48,326 --> 00:33:51,596 TOKEN PAYMENT. AND MORE RECENT 1029 00:33:51,662 --> 00:33:54,265 ONES DESCRIBE THIS IS A MINIMAL 1030 00:33:54,332 --> 00:33:54,899 PAYMENT. TOKEN SEEMS TO ME LIKE 1031 00:33:54,966 --> 00:33:55,500 ALMOST NO AMOUNT OF MONEY AT 1032 00:33:55,566 --> 00:34:00,972 ALL. MINIMAL MAYBE IS AT LEAST 1033 00:34:01,038 --> 00:34:02,140 A LITTLE BIT BETTER IN THAT 1034 00:34:02,206 --> 00:34:02,507 REGARD. 1035 00:34:02,573 --> 00:34:06,210 SO WHAT CAN IRBS DO IN THESE 1036 00:34:06,277 --> 00:34:15,253 CASES TO MAKE SURE THIS 1037 00:34:15,319 --> 00:34:15,853 CONCERNS ARE ADDRESSED? THE 1038 00:34:15,920 --> 00:34:16,387 FIRST IS TO MAKE SURE THE 1039 00:34:16,454 --> 00:34:16,954 RESEARCH IS APPROPRIATE AND 1040 00:34:17,021 --> 00:34:25,496 VALUABLE, AND THAT THE RISKS 1041 00:34:25,563 --> 00:34:26,130 ARE ADDRESSED AND YOU HAVE THE 1042 00:34:26,197 --> 00:34:26,764 RIGHT PROTECTIONS IN PLACE, AND 1043 00:34:26,831 --> 00:34:27,799 YOU MINIMIZE THE EXTENT TO 1044 00:34:27,865 --> 00:34:28,433 WHICH YOU CONDUCT THE RESEARCH 1045 00:34:28,499 --> 00:34:29,033 IN AN APPROPRIATE WAY. AND 1046 00:34:29,100 --> 00:34:30,968 MAKE SURE YOU ARE GETTING 1047 00:34:31,035 --> 00:34:32,904 ASSENT AND LOOKING AFTER KIDS' 1048 00:34:32,970 --> 00:34:40,044 DISSENT. IF YOU DOING THOSE 1049 00:34:40,111 --> 00:34:40,678 THINGS, LIES SOME INCENTIVES TO 1050 00:34:40,745 --> 00:34:44,048 PARENTS CAN BE ACCEPTABLE. AS I 1051 00:34:44,115 --> 00:34:45,183 SAID EARLIER WITHIN THE CONTEXT 1052 00:34:45,249 --> 00:34:45,817 OF MAKING SURE YOU ARE THINKING 1053 00:34:45,883 --> 00:34:47,218 ABOUT THE POSSIBILITY THAT 1054 00:34:47,285 --> 00:34:50,788 THERE MIGHT BE IDIOSYNCRATIC 1055 00:34:50,855 --> 00:34:51,289 RISKS OR CONCERNS FOR 1056 00:34:51,355 --> 00:34:53,357 PARTICULAR CHILDREN. 1057 00:34:53,424 --> 00:34:57,195 IN THEIR MEDICAL IDIOSYNCRATIC 1058 00:34:57,261 --> 00:34:57,829 RISKS, MAYBE A CLINICIAN SHOULD 1059 00:34:57,895 --> 00:35:00,364 EVALUATE THE CHILD. IF THERE 1060 00:35:00,431 --> 00:35:00,932 ARE MORE OBJECTIONS TO THE 1061 00:35:00,998 --> 00:35:02,667 RESEARCH THAT COULD BE A REASON 1062 00:35:02,733 --> 00:35:03,267 FOR SOMEBODY TO MEET WITH THE 1063 00:35:03,334 --> 00:35:03,901 CHILD INDEPENDENTLY OF THE 1064 00:35:03,968 --> 00:35:04,535 PARENTS, JUST TO MAKE SURE THAT 1065 00:35:04,602 --> 00:35:07,338 THEY ARE COMPARABLE AND WILLING 1066 00:35:07,405 --> 00:35:08,473 TO BE PART OF THE STUDY, IF 1067 00:35:08,539 --> 00:35:09,073 THERE ARE WORRIES THAT THEIR 1068 00:35:09,140 --> 00:35:10,875 AGREEMENT OR LACK OF ASSENT IS 1069 00:35:10,942 --> 00:35:14,979 NOT GOING TO BE SUFFICIENT. OR 1070 00:35:15,046 --> 00:35:15,513 IF THEY ARE NOT GOING TO 1071 00:35:15,580 --> 00:35:16,013 EXPRESS CONCERNS IN THE 1072 00:35:16,080 --> 00:35:18,082 PRESENCE OF THEIR PARENTS. 1073 00:35:18,149 --> 00:35:18,616 AND THE LAST THING AND THIS 1074 00:35:18,683 --> 00:35:19,484 MIGHT BE SOMETHING WORTH 1075 00:35:19,550 --> 00:35:22,386 TALKING ABOUT. IF THE INCENTIVE 1076 00:35:22,453 --> 00:35:24,255 TO THE PARENTS A RELATIVELY 1077 00:35:24,322 --> 00:35:25,623 SMALL, THAT DOESN'T CUT OFF ALL 1078 00:35:25,690 --> 00:35:26,257 CHANCES FOR THE PARENTS TO MAKE 1079 00:35:26,324 --> 00:35:30,528 MONEY. THE OTHER WAY THAT 1080 00:35:30,595 --> 00:35:31,162 COULD HAPPEN IS IF THEY DIVERT 1081 00:35:31,229 --> 00:35:31,796 SOME OF THE PAYMENTS THAT ARE 1082 00:35:31,863 --> 00:35:34,198 SUPPOSED TO GO TO THE MINORS. 1083 00:35:34,265 --> 00:35:34,799 AND OF THE PARENTS TAKE OVER 1084 00:35:34,866 --> 00:35:37,268 THOSE PAYMENTS. 1085 00:35:37,335 --> 00:35:37,835 AND SO THERE ARE VARIOUS WAYS 1086 00:35:37,902 --> 00:35:39,303 TO THINK ABOUT TRYING TO COME 1087 00:35:39,370 --> 00:35:42,940 UP WITH MECHANISMS TO ENSURE 1088 00:35:43,007 --> 00:35:43,608 PAYMENTS WHICH ARE INTENDED FOR 1089 00:35:43,674 --> 00:35:44,575 MINORS. THAT THEY GO TO 1090 00:35:44,642 --> 00:35:48,279 MINORS. ONE OF THE THINGS THAT 1091 00:35:48,346 --> 00:35:50,848 SOME PEOPLE USE IS GIFT CARDS 1092 00:35:50,915 --> 00:35:51,482 TO CERTAIN STORES FOR INSTANCE 1093 00:35:51,549 --> 00:35:53,217 THAT MINORS WOULD BE MORE 1094 00:35:53,284 --> 00:35:55,119 INTERESTED IN THAN PARENTS. 1095 00:35:55,186 --> 00:35:55,586 THAT IS AT LEAST ONE 1096 00:35:55,653 --> 00:36:02,393 POSSIBILITY. 1097 00:36:02,460 --> 00:36:02,927 ALL RIGHT. A SUMMARY. STILL 1098 00:36:02,994 --> 00:36:04,328 LIVING A LOT OF TIME FOR 1099 00:36:04,395 --> 00:36:04,896 DISCUSSION AND SEEING WHAT 1100 00:36:04,962 --> 00:36:06,831 EVERYBODY IS INTERESTED IN, AND 1101 00:36:06,898 --> 00:36:07,365 WANT TO TALK ABOUT. QUICK 1102 00:36:07,431 --> 00:36:10,101 SUMMARY. 1103 00:36:10,167 --> 00:36:10,635 HOPEFULLY WE ALL AGREE THAT 1104 00:36:10,701 --> 00:36:11,369 PEDIATRIC RESEARCH AT LEAST IN 1105 00:36:11,435 --> 00:36:12,203 GENERAL HAS IMPORTANT SOCIAL 1106 00:36:12,270 --> 00:36:15,039 VALUE. NOW AGAIN, THE CHALLENGE 1107 00:36:15,106 --> 00:36:17,375 FOR IRBS IS TO MAKE SURE THAT 1108 00:36:17,441 --> 00:36:19,744 THE STUDIES, THE INDIVIDUAL 1109 00:36:19,810 --> 00:36:20,912 STUDIES THAT WE APPROVE 1110 00:36:20,978 --> 00:36:21,546 ACTUALLY HAVE IMPORTANT SOCIAL 1111 00:36:21,612 --> 00:36:25,149 VALUE. NOT ENOUGH THAT IN 1112 00:36:25,216 --> 00:36:27,151 GENERAL, OR IN THE AGGREGATE OF 1113 00:36:27,218 --> 00:36:27,652 PEDIATRIC RESEARCH, HAS 1114 00:36:27,718 --> 00:36:29,754 IMPORTANT SOCIAL VALUE. WE 1115 00:36:29,820 --> 00:36:30,321 WANT TO MAKE SURE THAT THE 1116 00:36:30,388 --> 00:36:31,522 INDIVIDUAL STUDIES WE APPROVE, 1117 00:36:31,589 --> 00:36:36,160 INDIVIDUAL STUDIES WE CONDUCT, 1118 00:36:36,227 --> 00:36:36,761 INDIVIDUAL STUDIES WE ENROLL 1119 00:36:36,827 --> 00:36:39,363 CHILDREN IN HAVE IMPORTANT 1120 00:36:39,430 --> 00:36:40,264 SOCIAL VALUE. 1121 00:36:40,331 --> 00:36:40,765 AND THEY OBVIOUSLY RAISE 1122 00:36:40,831 --> 00:36:41,399 IMPORTANT ETHICAL CONCERNS AND 1123 00:36:41,465 --> 00:36:43,200 I THINK THAT THE INVOLVEMENT OF 1124 00:36:43,267 --> 00:36:46,070 ONE CAREFUL IRB EVALUATION AND 1125 00:36:46,137 --> 00:36:48,639 REVIEW AND INVOLVEMENT OF 1126 00:36:48,706 --> 00:36:59,250 ETHICALLY CONCERNED RESEARCHERS 1127 00:37:01,719 --> 00:37:02,153 TO OFFER A WAY DOES PERMIT 1128 00:37:02,219 --> 00:37:02,820 VALUABLE RESEARCH WHILE 1129 00:37:02,887 --> 00:37:03,321 ADDRESSING THE ETHICAL 1130 00:37:03,387 --> 00:37:04,322 CONCERNS. LOOK FORWARD TO YOUR 1131 00:37:04,388 --> 00:37:04,956 QUESTIONS AND COMMENTS. 1132 00:37:05,022 --> 00:37:08,359 >> PEG: THANK YOU VERY MUCH. 1133 00:37:08,426 --> 00:37:09,994 ANYBODY THAT HAS QUESTIONS 1134 00:37:10,061 --> 00:37:10,628 PLEASE GO AHEAD AND SUBMIT THEM 1135 00:37:10,695 --> 00:37:13,998 BY CLICKING ON THE BOX BELOW 1136 00:37:14,065 --> 00:37:15,199 THE VIDEO TITLED "LIVE 1137 00:37:15,266 --> 00:37:17,268 FEEDBACK." WE HAVE ONE COMMENT 1138 00:37:17,335 --> 00:37:18,202 OR QUESTION HERE. 1139 00:37:18,269 --> 00:37:21,405 THIS IS ABOUT ASSENT. THIS 1140 00:37:21,472 --> 00:37:24,976 INDIVIDUAL SAYS, HOW ABOUT A 1141 00:37:25,042 --> 00:37:26,110 MIXED APPROACH? FOLLOW THE 1142 00:37:26,177 --> 00:37:27,645 STEPS PRESENTED IN YOUR TALK. 1143 00:37:27,712 --> 00:37:30,514 GIVE INFORMATION TO ALL. ASK IF 1144 00:37:30,581 --> 00:37:31,148 THERE ARE QUESTIONS. SET AN AGE 1145 00:37:31,215 --> 00:37:34,552 OVER WHICH ASSENT IS A MUST, 1146 00:37:34,619 --> 00:37:37,655 12-14 AS SUGGESTED. BUT ALSO 1147 00:37:37,722 --> 00:37:39,857 HAVE A TRANSITION AGE SAY 8-12, 1148 00:37:39,924 --> 00:37:41,926 IN WHICH PARENTS ARE ASKED IF 1149 00:37:41,993 --> 00:37:42,526 THEY WANT THEIR CHILD TO GIVE 1150 00:37:42,593 --> 00:37:43,194 ASSENT. 1151 00:37:43,260 --> 00:37:45,596 >> DR. WENDLER: HMM. 1152 00:37:45,663 --> 00:37:52,169 INTERESTING. I HAVE GIVEN THIS 1153 00:37:52,236 --> 00:37:53,671 TALK A LOT OF TIMES AND I DO 1154 00:37:53,738 --> 00:37:55,272 NOT THINK I HAVE HEARD THAT 1155 00:37:55,339 --> 00:37:57,108 QUESTION BEFORE. 1156 00:37:57,174 --> 00:38:02,647 I GUESS, WITH THE IDEA BE ... 1157 00:38:02,713 --> 00:38:03,280 SO WOULD THE SUGGESTION BE YOU 1158 00:38:03,347 --> 00:38:06,817 ASK THE PARENTS, DO THEY THINK 1159 00:38:06,884 --> 00:38:08,919 THAT FOR THEIR CHILD, THEIR 1160 00:38:08,986 --> 00:38:09,754 CHILD ISN'T PARTICULARLY MATURE 1161 00:38:09,820 --> 00:38:16,460 OR SAVVY OR SOMETHING LIKE 1162 00:38:16,527 --> 00:38:18,963 THAT? THEY DON'T THINK IT'S 1163 00:38:19,030 --> 00:38:19,563 APPROPRIATE FOR THEM? OR THE 1164 00:38:19,630 --> 00:38:20,464 PARENTS JUST WANT THEM TO? 1165 00:38:20,531 --> 00:38:21,532 WHAT I WOULD SAY IS, MY 1166 00:38:21,599 --> 00:38:25,603 INCLINATION IS ... LET ME WRITE 1167 00:38:25,670 --> 00:38:26,203 THE QUESTION AND RESPOND BACK 1168 00:38:26,270 --> 00:38:27,371 TO THIS. I WOULD BE INCLINED 1169 00:38:27,438 --> 00:38:33,444 TO LEAVE THE ASSENT AT 12-14. 1170 00:38:33,511 --> 00:38:35,413 BUT AGAIN YOU GIVE INFORMATION 1171 00:38:35,479 --> 00:38:37,348 TO THE YOUNGER CHILDREN. YOU 1172 00:38:37,415 --> 00:38:40,117 TALK TO THEM. YOU GET THERE 1173 00:38:40,184 --> 00:38:42,720 VIEWS. AND AT A MINIMUM YOU 1174 00:38:42,787 --> 00:38:44,955 ENSURE THAT YOU ARE NOT 1175 00:38:45,022 --> 00:38:45,523 OBJECTING. AT LEAST YOU ARE 1176 00:38:45,589 --> 00:38:46,824 ENGAGING WITH THEM TO THAT 1177 00:38:46,891 --> 00:38:47,458 EXTENT. I WOULD DEFINITELY WANT 1178 00:38:47,525 --> 00:38:49,393 TO DO THAT. 1179 00:38:49,460 --> 00:38:51,295 ONE THING I WOULD SAY IS IF YOU 1180 00:38:51,362 --> 00:38:55,032 WANT TO GO BEYOND THAT TO SAY, 1181 00:38:55,099 --> 00:38:55,633 WE ARE GOING TO REQUIRE THEIR 1182 00:38:55,700 --> 00:38:56,934 ACTUAL AFFIRMATIVE AGREEMENT, 1183 00:38:57,001 --> 00:38:59,370 THE ONE THING I WORRY ABOUT IS 1184 00:38:59,437 --> 00:39:00,004 THAT THERE ARE SOME GUIDELINES 1185 00:39:00,071 --> 00:39:03,441 WHICH SAY WHAT YOU DO IS FOR 1186 00:39:03,507 --> 00:39:04,642 YOUNGER CHILDREN, YOU ASKED 1187 00:39:04,709 --> 00:39:07,311 WHETHER THEY ASSENT. YOU GIVE 1188 00:39:07,378 --> 00:39:09,246 THEM THIS INFORMATION AS I 1189 00:39:09,313 --> 00:39:09,847 SUGGESTED AND THEN YOU ASK IF 1190 00:39:09,914 --> 00:39:11,282 THEY AGREE AND IF THEY ASSENT. 1191 00:39:11,348 --> 00:39:13,984 AND THEN YOU GET THE ANSWER. IF 1192 00:39:14,051 --> 00:39:15,286 THEY SAY YES, THEY ARE IN THE 1193 00:39:15,352 --> 00:39:18,189 STUDY. IF THEY SAY NO, YOU TAKE 1194 00:39:18,255 --> 00:39:19,290 THAT INTO CONSIDERATION IN 1195 00:39:19,356 --> 00:39:21,692 DECIDING WHETHER OR NOT TO 1196 00:39:21,759 --> 00:39:22,660 ENROLL THEM. 1197 00:39:22,727 --> 00:39:23,260 AND THAT STRIKES ME AS A REALLY 1198 00:39:23,327 --> 00:39:25,429 BAD IDEA. I DON'T THINK WE 1199 00:39:25,496 --> 00:39:28,466 SHOULD BE POSITIVELY ASKING 1200 00:39:28,532 --> 00:39:29,066 MINORS, DO YOU WANT TO BE IN 1201 00:39:29,133 --> 00:39:30,768 THE STUDY? UNLESS WE'RE GOING 1202 00:39:30,835 --> 00:39:37,308 TO TAKE A "NO" AS A NO. 1203 00:39:37,374 --> 00:39:45,683 >> PEG: I IMAGINE, YOUR BIO 1204 00:39:45,750 --> 00:39:47,485 ETHICS COUNCIL MAY RUN INTO A 1205 00:39:47,551 --> 00:39:48,052 SIMILAR SITUATION WHERE YOU 1206 00:39:48,119 --> 00:39:50,020 HAVE A PROTOCOL THAT HAS 1207 00:39:50,087 --> 00:39:51,956 POTENTIAL FOR DIRECT BENEFIT, 1208 00:39:52,022 --> 00:39:52,523 SAY IN A POPULATION OF SICK 1209 00:39:52,590 --> 00:39:55,926 CHILDREN. AND THE INDIVIDUAL 1210 00:39:55,993 --> 00:39:57,061 PARENTS PROVIDE PERMISSION. 1211 00:39:57,128 --> 00:40:01,398 THE CHILD ASSENTS. AND AS THEY 1212 00:40:01,465 --> 00:40:03,768 GET INTO THE STUDY IT BECOMES 1213 00:40:03,834 --> 00:40:05,703 APPARENT THAT THE CHILD JUST 1214 00:40:05,770 --> 00:40:06,303 DOES NOT WANT TO CONTINUE IN 1215 00:40:06,370 --> 00:40:09,673 THE STUDY. SO WHEN YOU'RE FACED 1216 00:40:09,740 --> 00:40:11,509 WITH THAT, HOW DO YOU DEAL WITH 1217 00:40:11,575 --> 00:40:12,143 IT? 1218 00:40:12,209 --> 00:40:14,044 >> DR. WENDLER: SO THOSE ARE 1219 00:40:14,111 --> 00:40:16,413 REALLY INTERESTING CASES. THE 1220 00:40:16,480 --> 00:40:19,450 FIRST THING TO SAY ABOUT THAT 1221 00:40:19,517 --> 00:40:21,519 IS, MAYBE EVERYBODY KNOWS, BUT 1222 00:40:21,585 --> 00:40:22,086 A REMINDER THAT EVEN THOUGH 1223 00:40:22,153 --> 00:40:26,090 THERE IS THIS ASSENT 1224 00:40:26,157 --> 00:40:26,657 REQUIREMENT THE REGULATIONS 1225 00:40:26,724 --> 00:40:27,258 HAVE A PROVISO FOR WAVING IT, 1226 00:40:27,324 --> 00:40:28,259 IF THERE IS INSUFFICIENT CHANCE 1227 00:40:28,325 --> 00:40:31,162 FOR IMPORTANT POTENTIAL BENEFIT 1228 00:40:31,228 --> 00:40:33,063 FOR THE CHILDREN. 1229 00:40:33,130 --> 00:40:35,166 SO THAT IS ANOTHER CASE WHERE I 1230 00:40:35,232 --> 00:40:37,868 THINK THAT ASKING FOR 1231 00:40:37,935 --> 00:40:38,502 PERMISSION IS APPROPRIATE ONLY 1232 00:40:38,569 --> 00:40:39,403 IF YOU ARE GOING TO ACCEPT THE 1233 00:40:39,470 --> 00:40:43,440 "NO." IF THIS IS A POTENTIALLY 1234 00:40:43,507 --> 00:40:46,143 LIFE-SAVING PROTOCOL FOR CHILD, 1235 00:40:46,210 --> 00:40:46,777 AND ON THAT BASIS THE DECISION 1236 00:40:46,844 --> 00:40:48,479 HAS BEEN MADE, THAT YOU ARE 1237 00:40:48,546 --> 00:40:53,584 GOING TO NOT REQUIRE ASSENT 1238 00:40:53,651 --> 00:40:54,218 BEEN IN DECADES YOU SHOULD NOT 1239 00:40:54,285 --> 00:40:56,020 ASK THE CHILD FOR THEIR ASSENT. 1240 00:40:56,086 --> 00:40:56,520 YOU GIVE THEM ALL THE 1241 00:40:56,587 --> 00:40:57,688 INFORMATION AND YOU SAY, HERE 1242 00:40:57,755 --> 00:40:58,522 IS WHAT WE ARE PLANNING TO DO. 1243 00:40:58,589 --> 00:41:01,592 ANYTHING ASKING FOR ASSENT, YOU 1244 00:41:01,659 --> 00:41:05,863 GET A NO, AND THEN YOU TALK 1245 00:41:05,930 --> 00:41:08,866 ABOUT IT MORE AND HAVE THE 1246 00:41:08,933 --> 00:41:09,500 PARENTS DECIDE CAN BE A REALLY 1247 00:41:09,567 --> 00:41:12,036 BAD PROCESS. BUT WE DO GET 1248 00:41:12,102 --> 00:41:17,675 COUNCILS WHERE THE CHILD GETS 1249 00:41:17,741 --> 00:41:19,276 ENROLLED. THEY ARE NOW IN THE 1250 00:41:19,343 --> 00:41:19,877 MIDST OF A PROTOCOL AND THEY 1251 00:41:19,944 --> 00:41:20,477 START OBJECTING AND THEY WANT 1252 00:41:20,544 --> 00:41:22,146 OUT. THOSE ARE REALLY 1253 00:41:22,213 --> 00:41:22,780 INTERESTING, HEART CASES AND I 1254 00:41:22,847 --> 00:41:26,984 THINK CALLING A COUNCIL IS THE 1255 00:41:27,051 --> 00:41:27,551 RIGHT THING TO DO IN THOSE 1256 00:41:27,618 --> 00:41:30,521 CASES BECAUSE IT IS REALLY THE 1257 00:41:30,588 --> 00:41:36,794 ONLY WAY YOU CAN ASSESS THEM 1258 00:41:36,861 --> 00:41:37,428 AND GIVE RIGHT GUIDANCE TO KNOW 1259 00:41:37,494 --> 00:41:41,065 WHAT THE CIRCUMSTANCES ARE. 1260 00:41:41,131 --> 00:41:41,665 SO FOR A FULL OUT ONE OF THESE 1261 00:41:41,732 --> 00:41:46,503 EXAMPLES. I USE THIS IS AN 1262 00:41:46,570 --> 00:41:49,106 ARGUMENT. ONE OF THE COUNCILS 1263 00:41:49,173 --> 00:41:52,076 WE HAD AROUND ASSENT, PROBABLY 1264 00:41:52,142 --> 00:41:55,212 ABOUT 10 YEARS AGO, WE HAD A... 1265 00:41:55,279 --> 00:41:58,682 THIS ALSO BRINGS OUT ASSENT AND 1266 00:41:58,749 --> 00:42:01,719 COMPENSATION IN A WAY THAT IS 1267 00:42:01,785 --> 00:42:02,353 INTERESTING, THIS WAS A CASE OF 1268 00:42:02,419 --> 00:42:03,587 A KID WHO WAS NINE. WHO HAD A 1269 00:42:03,654 --> 00:42:09,793 VERY RARE NIH-TYPE DISEASE. 1270 00:42:09,860 --> 00:42:10,394 THEY HAD BEEN IN A NUMBER OF 1271 00:42:10,461 --> 00:42:11,028 STUDIES. HAD A LOT OF CLINICAL 1272 00:42:11,095 --> 00:42:12,630 CARE. AND THEY HAD A VERY RARE 1273 00:42:12,696 --> 00:42:18,102 VERSION OF THEIR DISEASE, WHICH 1274 00:42:18,168 --> 00:42:20,204 HAD NOT BEEN SEEN VERY OFTEN. 1275 00:42:20,271 --> 00:42:20,771 THE INVESTIGATORS THOUGHT IF 1276 00:42:20,838 --> 00:42:23,207 THEY COULD GET SOME BLOOD 1277 00:42:23,274 --> 00:42:29,179 THROUGH A REESE'S PROCEDURE 1278 00:42:29,246 --> 00:42:29,813 (SOUNDS LIKE) THEY MIGHT LEARN 1279 00:42:29,880 --> 00:42:31,015 MORE ABOUT THIS DISEASE ITSELF. 1280 00:42:31,081 --> 00:42:34,718 IN THAT CASE, THE IRB DECIDED 1281 00:42:34,785 --> 00:42:35,319 TO STIMULATE THAT THEY HAD TO 1282 00:42:35,386 --> 00:42:39,924 GET THE ASSENT BECAUSE IT WAS 1283 00:42:39,990 --> 00:42:40,557 NO PROSPECT OF DIRECT BENEFIT. 1284 00:42:40,624 --> 00:42:43,694 PURELY RESEARCH FOR REESE'S. 1285 00:42:43,761 --> 00:42:48,465 PRETTY STANDARD. THE PARENTS 1286 00:42:48,532 --> 00:42:49,033 WERE VERY SUPPORTIVE OF THE 1287 00:42:49,099 --> 00:42:50,234 RESEARCH ON THE DISEASE. THE 1288 00:42:50,301 --> 00:42:54,638 STIPULATED AND ETHICS COUNCIL. 1289 00:42:54,705 --> 00:42:55,272 SO I WENT UP AND TALK TO THIS 1290 00:42:55,339 --> 00:42:57,174 NINE-YEAR-OLD. HE WAS VERY 1291 00:42:57,241 --> 00:42:59,043 SMART, SAVVY. HE KNEW A LOT 1292 00:42:59,109 --> 00:43:02,980 ABOUT MEDICINE. I EXPLAINED 1293 00:43:03,047 --> 00:43:03,881 EVERYTHING TO HIM. AND THEN I 1294 00:43:03,948 --> 00:43:06,550 ASKED HIM. DO YOU WANT TO GO 1295 00:43:06,617 --> 00:43:07,818 THROUGH THIS PROCEDURE? HE SAID 1296 00:43:07,885 --> 00:43:13,023 NO. AND I ASKED WHY NOT. HE 1297 00:43:13,090 --> 00:43:17,161 JUST SAID, THERE'S A BASKET OR 1298 00:43:17,227 --> 00:43:22,333 HOOP ON THE END OF HIS FLOOR. 1299 00:43:22,399 --> 00:43:27,204 HE HAD A COUPLE OF BUDDIES. 1300 00:43:27,271 --> 00:43:29,540 THEY LIKE PLAYING BASKETBALL. 1301 00:43:29,606 --> 00:43:30,140 AND HE WENT DOWN FOR REESE'S 1302 00:43:30,207 --> 00:43:31,976 FOR 20 MINUTES, THAT WILL BE 20 1303 00:43:32,042 --> 00:43:35,412 MINUTES LESS PLAYTIME FOR HIM. 1304 00:43:35,479 --> 00:43:36,013 A REALLY REASONABLE DECISION 1305 00:43:36,080 --> 00:43:37,348 FOR NINE-YEAR-OLD WHO DOES NOT 1306 00:43:37,414 --> 00:43:37,881 UNDERSTAND WHAT HE COULD 1307 00:43:37,948 --> 00:43:39,416 CONTRIBUTE. BUT I THINK IT WAS 1308 00:43:39,483 --> 00:43:40,551 A MISTAKE TO LEAVE THAT 1309 00:43:40,617 --> 00:43:41,518 DECISION UP TO THAT 1310 00:43:41,585 --> 00:43:43,587 NINE-YEAR-OLD. 1311 00:43:43,654 --> 00:43:44,054 AND I THINK IF WE JUST 1312 00:43:44,121 --> 00:43:46,323 PRESENTED WHAT WE WERE DOING, 1313 00:43:46,390 --> 00:43:46,924 WE WOULD'VE GOTTEN THROUGH IT 1314 00:43:46,991 --> 00:43:49,727 ABSOLUTELY FINE. ANOTHER 1315 00:43:49,793 --> 00:43:51,428 THING, JUST TO GIVE 1316 00:43:51,495 --> 00:43:51,929 COMPENSATION ON THIS. I 1317 00:43:51,996 --> 00:43:55,432 ACTUALLY TALKED TO THAT CHILD 1318 00:43:55,499 --> 00:43:56,633 TWICE. HE WAS ADAMANT. HE WAS 1319 00:43:56,700 --> 00:43:58,002 NOT GOING TO DO IT. 1320 00:43:58,068 --> 00:44:01,872 AS I WAS LEAVING THE SECOND 1321 00:44:01,939 --> 00:44:02,373 TIME, I WALKED DOWN THE 1322 00:44:02,439 --> 00:44:04,675 HALLWAY. I PASSED HIS MOTHER. 1323 00:44:04,742 --> 00:44:05,309 HIS MOTHER WAS DISAPPOINTED BUT 1324 00:44:05,376 --> 00:44:07,211 SHE ACCEPTED HER SON'S DECISION 1325 00:44:07,277 --> 00:44:07,778 GIVEN THAT ASSENT WAS BEING 1326 00:44:07,845 --> 00:44:12,750 REQUIRED AND I SAID TO HER, BY 1327 00:44:12,816 --> 00:44:15,219 THE WAY WHAT DO YOU THINK WE 1328 00:44:15,285 --> 00:44:16,453 OFFERED $10? AND SHE SAID HE 1329 00:44:16,520 --> 00:44:17,054 WOULD ABSOLUTELY DONE IT IN A 1330 00:44:17,121 --> 00:44:21,859 HEARTBEAT. 1331 00:44:21,925 --> 00:44:22,459 SOWA QUESTION FOR THE AUDIENCE, 1332 00:44:22,526 --> 00:44:23,427 WHETHER OR NOT THAT WILL BE 1333 00:44:23,494 --> 00:44:24,995 ETHICALLY ACCEPTABLE TO OFFER 1334 00:44:25,062 --> 00:44:26,730 HIM $10. I THINK IT WOULD'VE 1335 00:44:26,797 --> 00:44:27,931 BEEN. 1336 00:44:27,998 --> 00:44:30,300 >> PEG: I DON'T THINK WE HAVE 1337 00:44:30,367 --> 00:44:35,606 ANY OTHER QUESTIONS. 1338 00:44:35,672 --> 00:44:36,206 DOES ANYONE ELSE HAVE ANYTHING 1339 00:44:36,273 --> 00:44:37,307 THEY WANT TO SUBMIT GO AHEAD. 1340 00:44:37,374 --> 00:44:38,308 BUT I DON'T SEE ANYTHING ELSE. 1341 00:44:38,375 --> 00:44:40,711 >> DR. WENDLER: GREAT. 1342 00:44:40,778 --> 00:44:43,313 >> PEG: THANK YOU VERY MUCH AND 1343 00:44:43,380 --> 00:44:46,316 I DO WANT TO PUT IN A PLUG. 1344 00:44:46,383 --> 00:44:51,422 CHRISTIAN READY CHIEF OF YOUR 1345 00:44:51,488 --> 00:44:51,922 BIOETHICS APARTMENT THE 1346 00:44:51,989 --> 00:44:52,556 PRESENTATION EARLIER THIS YEAR 1347 00:44:52,623 --> 00:44:53,924 ON COMPENSATION. AND YOU 1348 00:44:53,991 --> 00:44:55,392 ALLUDED TO YOUR DEPARTMENT'S 1349 00:44:55,459 --> 00:44:56,593 DISCUSSION ABOUT COMPENSATION 1350 00:44:56,660 --> 00:44:59,930 AND THOUGHTS ON IT. FOR PEOPLE 1351 00:44:59,997 --> 00:45:02,199 THAT ARE INTERESTED MORE ON 1352 00:45:02,266 --> 00:45:02,766 THAT TOPIC, I WOULD SUGGEST 1353 00:45:02,833 --> 00:45:04,068 THEY LOOK AT THAT. JANUARY 1354 00:45:04,134 --> 00:45:05,069 SESSION FROM THIS YEAR. 1355 00:45:05,135 --> 00:45:09,339 >> DR. WENDLER: CHRISTINE IS 1356 00:45:09,406 --> 00:45:09,973 ONE OF THE TRUE EXPERTS ON THE 1357 00:45:10,040 --> 00:45:10,474 ETHICS OF COMPENSATION 1358 00:45:10,541 --> 00:45:10,874 RESEARCH. 1359 00:45:10,941 --> 00:45:13,343 >> PEG: SHE WAS KIND ENOUGH TO 1360 00:45:13,410 --> 00:45:14,111 SHARE HER THOUGHTS WITH US. 1361 00:45:14,178 --> 00:45:16,113 >> DR. WENDLER: GREAT. 1362 00:45:16,180 --> 00:45:18,682 >> PEG: WE APPRECIATE YOU 1363 00:45:18,749 --> 00:45:20,250 JOINING US TODAY DR. WENDLER. 1364 00:45:20,317 --> 00:45:24,254 >> DR. WENDLER: THANKS PEG. 1365 00:45:24,321 BYE-BYE.