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GOOD AFTERNOON,
THANK YOU 

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FOR JOINING US FOR OUR FIRST 

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OHSRP EDUCATION SERIES SESSION 

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OF 2024 ENTITLED, TO PAY OR NOT 

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TO PAY, IS THAT THE QUESTION? 

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OUR PRESENTER ABOUT PARTICIPANT 

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COMPENSATION IS DR. CHRISTINE 

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GRADY, CHIEF OF THE DEPARTMENT 

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OF BIOETHICS, A NURSE BUY-ET 

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CYST AND SENIOR INVESTIGATOR 

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WHOSE RESEARCH CONTRIBUTIONS ARE

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IN ETHICS OF CLINICAL RESEARCH 

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INCLUDING INFORMED CONSENT, 

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VULNERABILITY, STUDY DESIGN, 

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RECRUITMENT, INTERNATIONAL 

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RESEARCH ETHICS AS WELL AS 

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ETHICAL ISSUES FACED BY NURSES 

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AND OTHER HEALTH CARE 

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PROFESSIONALS. FROM 2010-2017 

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DR. GRADY SERVED ON THE 

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PRESIDENT'S COMMISSION FOR 

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ISSUES, A FELLOW OF THE HASTINGS

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CENTER AND FELLOW OF ACADEMY OF 

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NURSING, KENNEDY INSTITUTE OF 

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ETHICS AND ELECTED MEMBER OF 

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NATIONAL ACADEMY OF MEDICINE. 

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DR. GRADY HOLDS A B. S. FROM 

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GEORGETOWN AND MSN FROM BOSTON 

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COLLEGE AND PH.D. FROM 

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GEORGETOWN UNIVERSITY. A FEW 

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DETAILS. TODAY'S PRESENTATION 

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WILL BE ARCHIVED IN THE PAST 

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EVENTS SECTION OF THE NIH VIDEO 

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CAST SITE. A LINK TO THE CAST AS

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WELL AS SLIDES WILL BE POSTED ON

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THE OHSRP WEBSITE APPROXIMATELY 

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ONE TO TWO WEEKS AFTER THE 

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SESSION. THAT WILL BE IN THE 

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PRESENTATION ARCHIVE SECTION OF 

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THE OHSRP EDUCATION PAGE. 

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FINALLY WE ENCOURAGE VIEWERS TO 

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SUBMIT QUESTIONS THROUGHOUT THE 

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SESSION BY CLICKING ON THE BOX 

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BELOW THE VIDEO TITLED LIVE 

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FEEDBACK LINK. WE WILL GET TO 

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THOSE QUESTIONS AFTER THE 

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PRESENTATION. THANK YOU FOR 

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JOINING US, DR. GRADY. YOU CAN 

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GO AHEAD AND GET STARTED. 

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   >> THANK YOU, PEG, VERY
MUCH 

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FOR INVITING ME. I CAN'T SEE WHO

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IS OUT THERE BUT HELLO TO 

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EVERYBODY OUT THERE. I'M GOING 

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TO START WITH MY DISCLAIMER. 

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THESE ARE MY VIEWS AND NOBODY 

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ELSE'S. I HAVE NO OTHER 

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CONFLICTS TO DISCLOSE. THESE ARE

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OBJECTIVES I PROVIDED TO PEG. I 

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WILL TALK ABOUT REASONS WE PAY, 

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RESEARCH AND COMMON ETHICAL 

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CONCERNS, FAMILIARIZE YOU WITH 

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EMPIRICAL DATA THAT WILL HELP 

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YOU UNDERSTAND REASONS AND 

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ETHICAL CONCERNS. THEN TALK A 

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LITTLE ABOUT POSSIBLE MODELS FOR

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PAYMENT AND CHALLENGES IN 

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DETERMINING HOW MUCH TO PAY. I 

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JUST MENTIONED THIS TO PEG A FEW

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MINUTES AGO. I WAS REMINDED THAT

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IN 2005 -- ALMOST 20 YEARS AGO 

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-- GAVE A TALK AT GRAND ROUNDS 

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AT THE CLINICAL CENTER ON 

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PAYMENT RESEARCH PARTICIPANTS. I

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ACTUALLY ENTITLED IT ALMOST THE 

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SAME, WITHOUT REMEMBERING THAT I

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HAD, TO PAY OR NOT TO PAY. SO I 

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STARTED THINKING ABOUT WHAT'S 

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CHANGED IN THOSE ALMOST 20 

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YEARS. INTERGLY SOME THINGS 

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HAVEN'T CHANGED AT ALL. I THINK 

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IT IS STILL TRUE THAT PAYMENT 

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EVEN THOUGH IT IS PRETTY COMMON 

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IS CONTROVERSIAL, REMAINS 

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CONTROVERSIAL. WHAT HAS CHANGED 

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-- FIRST OF ALL, I HAVE GOTTEN A

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LOT OLDER, ONE THING. THE OTHER 

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THING IS THERE IS A LOT MORE 

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EMPIRICAL DATA AND COMMENTARIES 

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ON PAYMENT. A LOT OF ACCEPTANCE 

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OF THE IDEA THAT WE SHOULD BE 

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PAYING PEOPLE IN MANY 

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CIRCUMSTANCES. SOME OF THE 

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CONTROVERSY STILL EXISTS, SO 

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THAT IS WHAT WE WILL TALK ABOUT 

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TODAY. SO PAYMENT IS WIDESPREAD 

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AND COMMON. WE DID A STUDY IN 

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2002, SO MORE THAN 20 YEARS AGO,

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THAT SHOWED THAT 80% OF RESEARCH

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INSTITUTES PAY PARTICIPANTS IN 

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AT LEAST SOME OF THE STUDIES. IT

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IS THE CASE AT THE CLINICAL 

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CENTER WE HAVE BEEN PAYING 

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PEOPLE IN RESEARCH ALMOST SINCE 

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THE DOORS OPENED OF THE CLINICAL

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CENTER. IT IS A LONG-STANDING 

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PRACTICE HERE AND IN THE WORLD. 

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ONE OF HIS TOR K -- HISTORICAL 

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EXAMPLES IS THAT OF WALTER REED.

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HE DID HIS YELLOW FEVER 

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EXPERIMENTS AROUND 1900. AT THAT

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TIME PAID $100 IN GOLD TO 

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PARTICIPANTS IN STUDY, ANOTHER 

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$100 IF THEY GOT INFECTED AND IF

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DIED $100 TO THEIR FAMILY THERE 

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ARE LOTS OF ADVERTISEMENTS 

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EVERYWHERE YOU LOOK ABOUT 

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GETTING PAID TO BE PART OF 

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RESEARCH. MANY OF THEM HAVE 

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NUMBER, SOME DON'T. I THINK THIS

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WAS INTERESTING IN IT SAID THESE

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LEGITIMATE CLINICAL TRIALS. 

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THERE ARE PHONE NUMBERS OR 

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PLACES TO FIND OUT A VARIETY OF 

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STUDIES THAT OFFER PAYMENT TO 

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PEOPLE. SOME OF THE WEBSITES ARE

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VERY EXPLICIT. THEY TELL YOU 

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WHAT THE AMOUNTS ARE AND DETAILS

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OF WHAT YOU HAVE TO DO FOR 

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DIFFERENT STUDIES. THERE'S EVEN 

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A WEBSITE THAT HAS THE 15 BEST 

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PAID WEBSITES -- NO, SORRY. 15 

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WEBSITES FOR BEST PAID RESEARCH 

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STUDIES IN THE COUNTRY THAT YOU 

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CAN GO TO AND FIND OUT ABOUT 

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DIFFERENT STUDIES. OUR CLINICAL 

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CENTER WEBSITE THAT FOCUSES ON 

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PATIENT RECRUITMENT SAYS WE AT 

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THE CLINICAL CENTER PROCESS OVER

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20,000 PAYMENT TRANSACTIONS A 

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YEAR TO BOTH PATIENTS AND 

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HEALTHY VOLUNTEERS. SO YOU CAN 

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SEE IT IS VERY COMMON AND VERY 

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WIDESPREAD. IT IS ALSO ALLOWED 

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BY REGULATIONS, I'M GOING TO 

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TALK ABOUT SOME OF THAT BRIEFLY,

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IT IS ETHICALLY ACCEPTABLE TO 

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PAY RESEARCH PARTICIPANTS. IT IS

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SURPRISINGLY PERENNIALLY 

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FRAUGHT. PEOPLE REALLY WORRY 

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ABOUT IT. SO WHAT ARE THE 

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REGULATIONS SAY? FDA HAS SOME 

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GUIDANCE ON PAYMENT, WHICH 

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EXPLICITLY SAYS PAYING 

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PARTICIPANTS IS ACCEPTABLE AND 

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SHOULD BE JUST AND FAIR. THE IRB

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HAS A ROLE IN REVIEWING BOTH THE

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AMOUNT AND THE METHODS OF 

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PAYING. THE METHOD AND THE 

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TIMING TO ASSURE NEITHER ARE 

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UNDULY INFLUENTIAL, PAYMENT 

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SHOULD PROGRESS AND SHOULD BE 

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PRORATED AND COMPLETION BONUSES 

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ARE ACCEPTABLE AS LONG AS THEY 

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ARE NOT COERCIVE OR UNDUE 

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INDUCEMENT. IN THE COMMON RULE 

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THERE IS NOTHING SPECIFIC TO 

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PAYMENT OTHER THAN AVOIDING 

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COERCION AND UNDUE INFLUENCE AS 

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A GENERAL RULE. BUT OHRP HAS 

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THIS INFORMED CONSENT FAQs ON 

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THEIR WEBSITE, ONE OF WHICH IS 

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ABOUT COMPENSATING RESEARCH 

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PARTICIPANTS AND WHETHER 

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UNDERMINED INFORMED CONSENT. IF 

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YOU READ THAT SECTION, BASICALLY

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REITERATES A LOT OF THINGS I 

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JUST SAID WERE ON THE FDA 

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GUIDANCE. THAT IT IS ACCEPTABLE,

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COMMON. HOWEVER, WE HAVE TO PAY 

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ATTENTION TO THE AMOUNT, THE 

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TIMING AND THE METHOD OF PAYMENT

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TO MAKE SURE IT IS NOT UNDULY 

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INFLUENTIAL OR COERCIVE. OF NOTE

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ON THIS FAQ PAGE, IF YOU LOOK 

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BELOW WHAT I HAVE HIEMEGHLIGHTE 

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CAN NON-FINANCIAL INCENTIVES 

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CONSTITUTE THIS. WITHOUT OPENING

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I WOULD SAY THE ANSWER THEY HAVE

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IS YES, THEY CAN. ABSOLUTELY 

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THEY CAN. IN THE INTRA MURAL 

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PROGRAM WE HAVE A POLICY OF 

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3014302 SUBJECT RECRUITMENT AND 

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COMPENSATION, WHICH YOU CAN FIND

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IN THE POLICY MANUAL, WHICH 

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TALKS ABOUT RECRUITMENT IN 

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GENERAL BUT COMPENSATION IN 

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SPECIFIC. GIVES GUIDANCE FOR 

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BOTH IRBs AND INVESTIGATORS AND 

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ALSO A GUIDELINE FOR 

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INVESTIGATORS ON PAYING RESEARCH

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PARTICIPANTS, WHICH HAS MORE 

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DETAIL IN IT. ETHICALLY 

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ACCEPTABLE, JUST ONE EXAMPLE, 

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THE CEOMS GUIDELINES EXPLICITLY 

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SAY THAT PARTICIPANTS SHOULD BE 

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-- NOT ONLY CAN BE BUT SHOULD BE

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REASONABLY REIMBURSED FOR COSTS 

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INCURRED AND COMPENSATED 

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REASONABLY FOR INCONVENIENCE AND

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THE TIME SPENT DOING RESEARCH. 

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THEN, OF COURSE, THEY ALSO 

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CAUTION THAT COMPENSATION 

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SHOULDN'T BE SO LARGE AS TO 

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INDUCE POTENTIAL PARTICIPANTS TO

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CONSENT AGAINST THEIR BETTER 

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JUDGMENT, WHICH THEY CALL UNDUE 

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INDUCEMENT, WHICH I WILL COME 

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BACK TO THAT IN A MINUTE. SOME 

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OF THE LITERATURE IN RECENT 

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YEARS HAS GONE A LITTLE FURTHER 

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AND SAID THE PROBLEM IS NOT THAT

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RESEARCH PARTICIPANTS ARE BEING 

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PAID BUT THAT THEY ARE NOT BEING

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PAID ENOUGH AND THAT WE OUGHT TO

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CHANGE THE DEFAULT TO FAVOR 

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RATHER THAN ENCOURAGE SUSPICION 

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OF OFFERS TO PAYMENT TO RESEARCH

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PARTICIPANTS. THIS IS JUST ONE 

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ARTICLE BY EMILY LARGEEN AND 

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EMILY FERNANDEZ LYNCH WHO HAVE 

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WRITTEN A NUMBER OF PAPERS ABOUT

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PAYMENT TO RESEARCH 

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PARTICIPANTS. SO EVEN THOUGH IT 

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IS ALLOWED, EVEN THOUGH IT IS 

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COMMON AND WIDESPREAD, ALLOWED 

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AND ETHICALLY ACCEPTABLE IT 

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CONTINUES TO BE -- THIS ALWAYS 

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SURPRISES ME, I HAVE TO SAY -- 

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PERLY FRAUGHT. I HAVE DONE THIS 

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SOME YEARS BECAUSE I ENCOUNTERED

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IN CLINICAL STUDIES WITH 

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INVESTIGATORS ON VARIOUS 

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VIEWPOINTS ON WHETHER OR NOT TO 

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PAY PEOPLE. WHETHER OR NOT IT 

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WAS OKAY. NOT JUST WHETHER OR 

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NOT TO DO IT BUT WHETHER OR NOT 

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IT WAS OKAY TO. SO I THINK WHEN 

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I THOUGHT ABOUT THIS FROM AN 

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ETHICAL PERSPECTIVE FOR MANY, 

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MANY YEARS, I LIKE TO THINK 

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ABOUT IN MORE DETAIL THE REASONS

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WE PAY PEOPLE. WHAT ARE THE 

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REASONS WE OFFER PAYMENT AND 

254
00:10:21,505 --> 00:10:23,407
WHAT ARE THE CONCERNS AND HOW TO

255
00:10:23,407 --> 00:10:24,541
PUT THOSE TOGETHER AND LOOK AT 

256
00:10:24,541 --> 00:10:26,376
SOME OF THE EMPIRICAL DATA 

257
00:10:26,376 --> 00:10:28,278
THAT'S ADDRESSED BOTH OF THEM. 

258
00:10:28,278 --> 00:10:31,048
SO WHY DO WE OFFER PAYMENT? I 

259
00:10:31,048 --> 00:10:32,149
THINK THE MOST COMMON REASON 

260
00:10:32,149 --> 00:10:33,851
CITED IS IT WILL HELP 

261
00:10:33,851 --> 00:10:35,652
RECRUITMENT AND ENROLLMENT. THAT

262
00:10:35,652 --> 00:10:37,588
IS AN IMPORTANT THING. WE ALL 

263
00:10:37,588 --> 00:10:39,690
KNOW THAT RECRUITMENT AND 

264
00:10:39,690 --> 00:10:43,093
ENROLLMENT OF PARTICIPANTS IN A 

265
00:10:43,093 --> 00:10:46,463
TIMELY MANNER IS CRITICAL TO THE

266
00:10:46,463 --> 00:10:50,567
COMPLETION OF CHRISTLINICAL TRIO

267
00:10:50,567 --> 00:10:51,935
SATISFY THE SOCIAL AND 

268
00:10:51,935 --> 00:10:53,103
SCIENTIFIC VALUE OF RESEARCH, 

269
00:10:53,103 --> 00:10:55,339
THE STUDY HAS TO BE DONE AND IN 

270
00:10:55,339 --> 00:10:58,108
A WAY THAT -- AS IT WAS PLANNED,

271
00:10:58,108 --> 00:11:00,777
AS IT MAKES SENSE. WE KNOW THAT 

272
00:11:00,777 --> 00:11:02,746
RECRUITING AND RETAINING 

273
00:11:02,746 --> 00:11:03,847
PARTICIPANTS IN RESEARCH IS A 

274
00:11:03,847 --> 00:11:04,815
FREQUENT CHALLENGE. IN FACT, 

275
00:11:04,815 --> 00:11:07,017
SOME OF THE DATA THAT EXISTS 

276
00:11:07,017 --> 00:11:10,554
SUGGESTS UP TO 40% OF TRIALS ARE

277
00:11:10,554 --> 00:11:13,957
NOT FINISHED IN TIME BECAUSE 

278
00:11:13,957 --> 00:11:16,994
THEY CAN'T ENROLL ENOUGH 

279
00:11:16,994 --> 00:11:18,862
PARTICIPANTS. SOME CLOSE WITH 

280
00:11:18,862 --> 00:11:20,931
UNDERPOWERED TRIALS BECAUSE THEY

281
00:11:20,931 --> 00:11:24,167
CAN'T GET THE RECRUITMENT 

282
00:11:24,167 --> 00:11:27,671
TARGETS THAT THEY HAVE. THIS 

283
00:11:27,671 --> 00:11:31,909
INDUSTRY -- SORRY, INDUSTRY 

284
00:11:31,909 --> 00:11:33,844
STANDARD REPORT IN 2014 IS A 

285
00:11:33,844 --> 00:11:35,779
REPORT THAT HAS -- IS 

286
00:11:35,779 --> 00:11:39,116
SPECIFICALLY ABOUT RECRUITMENT. 

287
00:11:39,116 --> 00:11:40,817
BASICALLY TALKS ABOUT THE 

288
00:11:40,817 --> 00:11:42,986
PROBLEMS WITH DELAYING IN 

289
00:11:42,986 --> 00:11:45,022
FINISHING CLINICAL TRIALS, THE 

290
00:11:45,022 --> 00:11:48,125
COSTS TO INDUSTRY OF NOT 

291
00:11:48,125 --> 00:11:48,792
COMPLETING A CLINICAL TRIAL IN 

292
00:11:48,792 --> 00:11:50,527
TIME AND SAYS WE SHOULD USE ANY 

293
00:11:50,527 --> 00:11:52,896
AND ALL MEANS TO INCREASE 

294
00:11:52,896 --> 00:11:54,831
ENROLLMENT AND RETENTION. SO ONE

295
00:11:54,831 --> 00:11:57,301
OF THOSE MEANS THAT PEOPLE HAVE 

296
00:11:57,301 --> 00:11:59,336
TALKED ABOUT IS OFFERING PAYMENT

297
00:11:59,336 --> 00:12:01,038
TO RESEARCH PARTICIPANTS. SO THE

298
00:12:01,038 --> 00:12:04,641
QUESTION I WANT US TO THINK 

299
00:12:04,641 --> 00:12:09,146
THROUGH IS HOW WELL DOES 

300
00:12:09,146 --> 00:12:11,315
OFFERING INCREASE RATES OF 

301
00:12:11,315 --> 00:12:13,483
ENROLLMENT? UNLIKE 2005 WE 

302
00:12:13,483 --> 00:12:14,885
ACTUALLY HAVE DATA, WHICH IS 

303
00:12:14,885 --> 00:12:17,120
VERY USEFUL. STARTING WITH THREE

304
00:12:17,120 --> 00:12:19,456
DIFFERENT KINDS OF RESEARCH. IN 

305
00:12:19,456 --> 00:12:20,457
SURVEYS THERE HAVE BEEN A NUMBER

306
00:12:20,457 --> 00:12:23,327
OF STUDIES THAT HAVE SHOWN THAT 

307
00:12:23,327 --> 00:12:25,095
EVEN A VERY SMALL AMOUNT OF 

308
00:12:25,095 --> 00:12:27,264
MONEY, SOMETIMES $5 IN THE 

309
00:12:27,264 --> 00:12:30,200
ENVELOPE OR PROMISE TO SOMEBODY,

310
00:12:30,200 --> 00:12:33,470
INCREASES THE RESPONSE RATES FOR

311
00:12:33,470 --> 00:12:35,606
SURVEYS. THAT MONEY IS MORE 

312
00:12:35,606 --> 00:12:37,341
EFFECTIVE THAN VOUCHERS OR 

313
00:12:37,341 --> 00:12:40,310
LOTTERIES OR OTHER MEANS OF 

314
00:12:40,310 --> 00:12:42,579
PERHAPS INCENTIVISING PEOPLE TO 

315
00:12:42,579 --> 00:12:45,082
FINNISH A SURVEY. THE CITATION I

316
00:12:45,082 --> 00:12:47,918
HAVE HERE IS A SYSTEMATIC REVIEW

317
00:12:47,918 --> 00:12:50,721
AND META ANALYSIS JUST PUBLISHED

318
00:12:50,721 --> 00:12:53,156
THIS YEAR IN PLUS ONE THAT 

319
00:12:53,156 --> 00:12:55,892
REVIEWS 46 DIFFERENT STUDIES. 

320
00:12:55,892 --> 00:12:57,728
THAT LOOKED AT WHETHER OR NOT 

321
00:12:57,728 --> 00:12:58,895
PAYMENT INCREASED SURVEY 

322
00:12:58,895 --> 00:13:02,666
RESPONSE RATES. THE ANSWER IS 

323
00:13:02,666 --> 00:13:05,636
YES, IT DOES. WHAT ABOUT HEALTHY

324
00:13:05,636 --> 00:13:06,770
VOLUNTEER S? WE WERE ABLE TO DO 

325
00:13:06,770 --> 00:13:10,540
A STUDY A FEW YEARS AGO 

326
00:13:10,540 --> 00:13:12,743
FOLLOWING 1200 HEALTHY VOLUNTEER

327
00:13:12,743 --> 00:13:15,812
WHO'S PARTICIPATED IN PFIZER 

328
00:13:15,812 --> 00:13:17,347
PHASE 1 DRUG DEVELOPMENT 

329
00:13:17,347 --> 00:13:20,851
STUDIES. SO THESE ARE SURVEY 

330
00:13:20,851 --> 00:13:22,185
DATA FROM THOSE 1200 PEOPLE. 

331
00:13:22,185 --> 00:13:25,889
WHAT YOU'LL SEE IS A COUPLE 

332
00:13:25,889 --> 00:13:27,791
THINGS. THIS IS A SLIDE, EXCUSE 

333
00:13:27,791 --> 00:13:30,260
ME, SHOWING MOTIVATIONS FOR 

334
00:13:30,260 --> 00:13:31,595
PARTICIPATION. THE BLUE BEING 

335
00:13:31,595 --> 00:13:33,964
MAIN MOTIVATION, RED BEING ANY 

336
00:13:33,964 --> 00:13:35,399
MOTIVATION. YOU WILL SEE MONEY 

337
00:13:35,399 --> 00:13:37,134
FAR EXCEEDS ANY OF THE OTHER 

338
00:13:37,134 --> 00:13:39,202
MOTIVATIONS PEOPLE DESCRIBE IN 

339
00:13:39,202 --> 00:13:40,937
THIS HEALTHY VOLUNTEER GROUP. WE

340
00:13:40,937 --> 00:13:43,040
ALSO ASKED THEM TO TELL US WHICH

341
00:13:43,040 --> 00:13:45,742
WAS MORE IMPORTANT IN SERIES OF 

342
00:13:45,742 --> 00:13:47,077
TRADE-OFF QUESTIONS. TO THEIR 

343
00:13:47,077 --> 00:13:51,281
DECISION TO ENROLL IN STUDIES AT

344
00:13:51,281 --> 00:13:53,517
PFIZER. YOU CAN SEE IN ALMOST 

345
00:13:53,517 --> 00:13:55,018
EVERY CASE MONEY BEATS OUT 

346
00:13:55,018 --> 00:13:57,187
ANYTHING ELSE. ANY OTHER 

347
00:13:57,187 --> 00:13:59,389
CONSIDERATIONS. EXCEPT -- THIS 

348
00:13:59,389 --> 00:14:03,193
IS REALLY IMPORTANT. EXCEPT FOR 

349
00:14:03,193 --> 00:14:05,429
RISK. THIS COHORT TOLD US THAT 

350
00:14:05,429 --> 00:14:07,164
RISKS AND SIDE EFFECTS WERE MORE

351
00:14:07,164 --> 00:14:09,099
IMPORTANT TO THEIR ENROLLMENT 

352
00:14:09,099 --> 00:14:11,702
DECISION THAN THE MONEY BEING 

353
00:14:11,702 --> 00:14:13,203
OFFERED. WE ALSO FOUND IN A 

354
00:14:13,203 --> 00:14:16,106
DIFFERENT STUDY WHERE WE DID A 

355
00:14:16,106 --> 00:14:18,742
SYSTEMATIC REVIEW HEALTHY 

356
00:14:18,742 --> 00:14:19,342
VOLUNTEERS ALTHOUGH ALMOST 

357
00:14:19,342 --> 00:14:20,510
ALWAYS MOTIVATED BY MONEY ALSO 

358
00:14:20,510 --> 00:14:23,280
REPORT A NUMBER OF THERMO TIFS, 

359
00:14:23,280 --> 00:14:29,586
INCLUDING THINGS LIKE CURIOSITY,

360
00:14:29,586 --> 00:14:31,688
SEEKING KNOWLEDGE, ALTRUISTIC 

361
00:14:31,688 --> 00:14:35,292
AND SENSATION-SEEKING. THIS WAS 

362
00:14:35,292 --> 00:14:40,097
A COCKERING REVIEW, LOOKING AT 

363
00:14:40,097 --> 00:14:43,100
IMPROVED METHODS TO RECRUITMENT 

364
00:14:43,100 --> 00:14:44,668
TRIALS. FINANCIAL INCENTIVES, 

365
00:14:44,668 --> 00:14:46,136
THIS IS A -- I DON'T KNOW IF YOU

366
00:14:46,136 --> 00:14:48,872
CAN SEE THIS IS THE INCREASED 

367
00:14:48,872 --> 00:14:50,640
COLUMNS. FINANCIAL INCENTIVES 

368
00:14:50,640 --> 00:14:53,677
INCREASED RECRUITMENT. INTERGLY 

369
00:14:53,677 --> 00:14:56,313
IN THIS META ANALYSIS THEY ONLY 

370
00:14:56,313 --> 00:14:59,316
HAD THREE INCLUDED, TWO WERE 

371
00:14:59,316 --> 00:15:00,383
HYPOTHETICAL. BUT THEY WERE -- 

372
00:15:00,383 --> 00:15:02,352
IN ALL THREE THEY WERE ABLE TO 

373
00:15:02,352 --> 00:15:03,820
SHOW OFFERING MONEY INCREASED 

374
00:15:03,820 --> 00:15:07,090
THE CHANCES OF ENROLLMENT. THIS 

375
00:15:07,090 --> 00:15:09,559
IS A MORE RECENT STUDY DONE BY 

376
00:15:09,559 --> 00:15:12,095
SCOTT HALPERN AND HIS COLLEAGUES

377
00:15:12,095 --> 00:15:13,897
AT THE UNIVERSITY OF 

378
00:15:13,897 --> 00:15:15,165
PENNSYLVANIA. IT IS A REALLY 

379
00:15:15,165 --> 00:15:16,900
INTERESTING STUDY. WHAT THEY 

380
00:15:16,900 --> 00:15:20,337
WERE ABLE TO DO WAS TAKE TWO 

381
00:15:20,337 --> 00:15:22,939
CLINICAL TRIALS AND IN THEM 

382
00:15:22,939 --> 00:15:25,008
EMBED RANDOMIZATION TO DIFFERENT

383
00:15:25,008 --> 00:15:26,576
LEVELS OF OFFERS OF PAYMENT. SO 

384
00:15:26,576 --> 00:15:29,412
THIS WAS A SMOKING CESSATION 

385
00:15:29,412 --> 00:15:32,582
TRIAL DONE IN A NUMBER OF 

386
00:15:32,582 --> 00:15:34,918
CLINICS. RANDOMIZED THE GROUP IN

387
00:15:34,918 --> 00:15:36,219
THOSE WHO WERE TOLD THEY 

388
00:15:36,219 --> 00:15:37,454
RECEIVED NO MONEY, THOSE THAT 

389
00:15:37,454 --> 00:15:39,356
RECEIVED $200, THOSE THAT 

390
00:15:39,356 --> 00:15:42,092
RECEIVED $500. THE OTHER TRIAL 

391
00:15:42,092 --> 00:15:44,795
WAS AN AMBULATION TRIAL DONE IN 

392
00:15:44,795 --> 00:15:47,764
THE IN-PATIENT UNIT OF HOP. 

393
00:15:47,764 --> 00:15:50,333
AGAIN, PERSONS WERE RANDOMIZED 

394
00:15:50,333 --> 00:15:56,006
TO RECEIVE NO MONEY, $100 OR 

395
00:15:56,006 --> 00:15:57,974
$300. WHAT IS INTERESTING IS IN 

396
00:15:57,974 --> 00:15:59,342
THE SMOKING TRIAL THE AMOUNT OF 

397
00:15:59,342 --> 00:16:01,912
MONEY BEING OFFERED HAD A 

398
00:16:01,912 --> 00:16:03,180
SIGNIFICANT EFFECT ON 

399
00:16:03,180 --> 00:16:04,314
ENROLLMENT. MORE THAN TWICE AS 

400
00:16:04,314 --> 00:16:07,317
MANY PEOPLE OFFERED $500 

401
00:16:07,317 --> 00:16:08,718
ENROLLED IN THOSE THAN OFFERED 

402
00:16:08,718 --> 00:16:10,954
NOTHING. IN THE AMBULATION TRIAL

403
00:16:10,954 --> 00:16:14,825
DIDN'T MAKE A DIFFERENCE AT ALL.

404
00:16:14,825 --> 00:16:17,360
DIDN'T INCREASE ENROLLMENT AT 

405
00:16:17,360 --> 00:16:19,963
ALL. THIS IS A BUSY SLIDE BUT IF

406
00:16:19,963 --> 00:16:24,501
YOU LOOK RIGHT BUT LOW THE ONE I

407
00:16:24,501 --> 00:16:26,803
HAVE HIGHLIGHTED, ANOTHER 

408
00:16:26,803 --> 00:16:28,572
INTERESTING THING TO NOTE IS IN 

409
00:16:28,572 --> 00:16:31,708
THE SMOKING TRIAL ABOUT HALF THE

410
00:16:31,708 --> 00:16:34,711
PEOPLE IN ALL OF THE 

411
00:16:34,711 --> 00:16:35,545
COMPENSATION GROUPS THOUGHT 

412
00:16:35,545 --> 00:16:37,714
THERE WAS SOME RISK ASSOCIATED 

413
00:16:37,714 --> 00:16:40,817
WITH THE TRIAL. WHEREAS IN THE 

414
00:16:40,817 --> 00:16:41,685
AMBULATION TRIAL ALMOST NOBODY 

415
00:16:41,685 --> 00:16:42,919
THOUGHT THERE WAS SOME RISK. 

416
00:16:42,919 --> 00:16:44,521
THOUGH THERE WAS A LITTLE BIT OF

417
00:16:44,521 --> 00:16:49,626
A HIGHER RISK IN THE $300 GROUP 

418
00:16:49,626 --> 00:16:53,897
THAN THE REST. SO ANOTHER THING 

419
00:16:53,897 --> 00:16:54,831
PEOPLE THINK IS OFFERING PAYMENT

420
00:16:54,831 --> 00:16:57,100
MIGHT HELP WITH RECRUITING 

421
00:16:57,100 --> 00:16:57,934
UNDERREPRESENTED GROUPS. SO 

422
00:16:57,934 --> 00:16:59,569
THERE HAVE BEEN A NUMBER OF 

423
00:16:59,569 --> 00:17:02,973
STUDIES THAT HAVE LOOKED AT 

424
00:17:02,973 --> 00:17:09,212
THIS. ONE STUDY BY JENNINGS ET 

425
00:17:09,212 --> 00:17:12,115
AL. IN 2015 FOUND ALTHOUGH 

426
00:17:12,115 --> 00:17:13,683
PAYMENTS MARGINALLY IMPROVE 

427
00:17:13,683 --> 00:17:16,286
RECRUITMENT RATES INTO SOME 

428
00:17:16,286 --> 00:17:18,021
TRIALS, IT DID NOT BROAD EN 

429
00:17:18,021 --> 00:17:21,191
THEIR DEMOGRAPHICS. THEY LOOKED 

430
00:17:21,191 --> 00:17:22,926
SPECIFICALLY AT SOCIALLY 

431
00:17:22,926 --> 00:17:26,229
DEPRIVED INDIVIDUALS AND ELDERLY

432
00:17:26,229 --> 00:17:28,899
PATIENTS. IN ANOTHER STUDY THEY 

433
00:17:28,899 --> 00:17:31,635
FOUND THAT LOW INCOME 

434
00:17:31,635 --> 00:17:32,836
INDIVIDUALS, WHEN ASKED FOR A 

435
00:17:32,836 --> 00:17:34,838
HYPOTHETICAL SCENARIO, REQUESTED

436
00:17:34,838 --> 00:17:37,207
SIMILAR AMOUNTS OF PAYMENT FOR 

437
00:17:37,207 --> 00:17:39,009
PARTICIPATION AS THEIR 

438
00:17:39,009 --> 00:17:40,510
HIGH-INCOME PEERS BUT THAT 

439
00:17:40,510 --> 00:17:41,678
HIGHER PAYMENT MIGHT BE 

440
00:17:41,678 --> 00:17:44,247
NECESSARY TO INCREASE OVERALL 

441
00:17:44,247 --> 00:17:46,883
PARTICIPATION IN SOME STUDIES. 

442
00:17:46,883 --> 00:17:49,886
BARBARA BAYER AND COLLEAGUES 

443
00:17:49,886 --> 00:17:51,454
HAVE WRITTEN STUDIES TRYING TO 

444
00:17:51,454 --> 00:17:53,690
MAKE THE CASE WHEN WE ARE 

445
00:17:53,690 --> 00:17:54,891
ENROLLING PEOPLE IN RESEARCH, WE

446
00:17:54,891 --> 00:17:56,860
WANT TO BE SURE THAT THEY ARE 

447
00:17:56,860 --> 00:18:00,597
NOT MADE WORSE OFF. THAT IS A 

448
00:18:00,597 --> 00:18:02,098
GENERAL SORT OF NORMAL OF 

449
00:18:02,098 --> 00:18:04,601
RESEARCH. THAT INCLUDES 

450
00:18:04,601 --> 00:18:07,103
FINANCIALLY WORSE OFF. SO 

451
00:18:07,103 --> 00:18:09,639
THEY'VE ARGUED FOR PAYING 

452
00:18:09,639 --> 00:18:11,841
ACTUALLY MORE MONEY TO TRY TO 

453
00:18:11,841 --> 00:18:14,778
NOT MAKE PEOPLE OF LOWER 

454
00:18:14,778 --> 00:18:17,147
SOCIOECONOMIC STATUS FINANCIALLY

455
00:18:17,147 --> 00:18:17,714
WORSE OFF. 

456
00:18:17,714 --> 00:18:20,750
    THIS RAISES THE ISSUE OF 

457
00:18:20,750 --> 00:18:22,485
WHICH WE KNOW MORE ABOUT THAN WE

458
00:18:22,485 --> 00:18:25,021
DID 20 YEARS AGO THAT ACTUALLY 

459
00:18:25,021 --> 00:18:26,556
COSTS OF RESEARCH PARTICIPATION 

460
00:18:26,556 --> 00:18:29,826
CAN BE A DETERRENT. CLINICAL 

461
00:18:29,826 --> 00:18:31,494
TRIALS CAN POSE SUBSTANTIAL 

462
00:18:31,494 --> 00:18:34,230
COSTS, BOTH FROM HEALTH-RELATED 

463
00:18:34,230 --> 00:18:36,700
COSTS, NOT COVERED BY THE TRIAL 

464
00:18:36,700 --> 00:18:38,301
OR THE INSURANCE OF THE 

465
00:18:38,301 --> 00:18:39,369
PARTICIPANT. OF COURSE THIS IS 

466
00:18:39,369 --> 00:18:41,604
LESS RELEVANT FOR THE CLINICAL 

467
00:18:41,604 --> 00:18:44,007
CENTER, THAT KIND OF COST, BUT 

468
00:18:44,007 --> 00:18:45,308
ALSO INDIRECT COST, LIKE TRAVEL 

469
00:18:45,308 --> 00:18:47,344
AND LOST WAGES AND LODGING, 

470
00:18:47,344 --> 00:18:49,512
THINGS LIKE THAT. IT IS ALSO 

471
00:18:49,512 --> 00:18:51,414
TRUE THAT PEOPLE WHO ARE AT 

472
00:18:51,414 --> 00:18:53,550
HIGHEST RISK FOR FINANCIAL 

473
00:18:53,550 --> 00:18:54,317
TOXICITY, IN OTHER WORDS, THOSE 

474
00:18:54,317 --> 00:18:57,320
WHO CAN'T AFFORD SOME OF THESE 

475
00:18:57,320 --> 00:18:58,855
COSTS, ARE EXACTLY THOSE WHO ARE

476
00:18:58,855 --> 00:19:02,826
LESS LIKELY TO PARTICIPATE IN 

477
00:19:02,826 --> 00:19:08,631
CLINICAL TRIALS. WE ALL KNOW 

478
00:19:08,631 --> 00:19:09,933
SKEWED PARTICIPATION CAN SKEW 

479
00:19:09,933 --> 00:19:12,268
THE VALIDITY SO WE NEED A 

480
00:19:12,268 --> 00:19:13,536
BALANCED PATIENT POPULATION TO 

481
00:19:13,536 --> 00:19:14,871
HAVE GENERAL IZABLE RESULTS. 

482
00:19:14,871 --> 00:19:19,442
SOME OF THIS WAS TAKEN FROM AN 

483
00:19:19,442 --> 00:19:20,777
ASKO EDUCATIONAL BOOK 

484
00:19:20,777 --> 00:19:22,645
SPECIFICALLY FOCUSED ON 

485
00:19:22,645 --> 00:19:26,349
FINANCIAL TOXICITY AND ACCESS. 

486
00:19:26,349 --> 00:19:30,520
THIS WAS A BLOG SITE THAT LOOKED

487
00:19:30,520 --> 00:19:33,623
SPECIFICALLY AND WAS JUST 

488
00:19:33,623 --> 00:19:35,225
PUBLISHED A YEAR AGO THAT LOOKED

489
00:19:35,225 --> 00:19:36,860
SPECIFICALLY AT POVERTY AND 

490
00:19:36,860 --> 00:19:39,529
PARTICIPATION IN RESEARCH. OF 

491
00:19:39,529 --> 00:19:40,964
COURSE WE KNOW FROM RESEARCH 

492
00:19:40,964 --> 00:19:42,365
THAT PATIENTS FROM 

493
00:19:42,365 --> 00:19:44,200
UNDERREPRESENTED AND 

494
00:19:44,200 --> 00:19:45,835
UNDERRESOURCED COMMUNITIES ARE 

495
00:19:45,835 --> 00:19:47,103
MORE LIKELY TO EXPERIENCE 

496
00:19:47,103 --> 00:19:50,807
POVERTY AND HAVE POOR HEALTH 

497
00:19:50,807 --> 00:19:52,075
OUTCOMES. WHAT THIS GROUP DID 

498
00:19:52,075 --> 00:19:55,045
WAS FIND DATA THAT SUGGESTED 

499
00:19:55,045 --> 00:19:56,146
THAT RESEARCH ALSO CAN LEAVE 

500
00:19:56,146 --> 00:19:58,148
THESE POPULATIONS BEHIND. ONE OF

501
00:19:58,148 --> 00:20:01,451
THE MAJOR BARRIERS TO 

502
00:20:01,451 --> 00:20:03,153
PARTICIPATION ARE THE COSTS, 

503
00:20:03,153 --> 00:20:05,455
TIME AND RESOURCE CONSTRAINTS 

504
00:20:05,455 --> 00:20:06,856
ASSOCIATED WITH PARTICIPATION. 

505
00:20:06,856 --> 00:20:10,627
SO THESE KIND OF DATA SUGGESTS 

506
00:20:10,627 --> 00:20:14,097
MORE REASONS TO PAY PEOPLE 

507
00:20:14,097 --> 00:20:15,999
BEYOND INCREASING RECRUITMENT 

508
00:20:15,999 --> 00:20:17,367
AND ENROLLMENT. THESE ARE 

509
00:20:17,367 --> 00:20:19,035
REASONS WHICH I THINK ETHICALLY 

510
00:20:19,035 --> 00:20:22,505
MAKE A LOT OF SENSE. CERTAINLY 

511
00:20:22,505 --> 00:20:24,240
SOMETIMES PAYMENT CAN ENABLE 

512
00:20:24,240 --> 00:20:27,811
PEOPLE TO PARTICIPATE WHO CAN'T 

513
00:20:27,811 --> 00:20:32,482
AFFORD SOME OF THOSE DAYS AWAY 

514
00:20:32,482 --> 00:20:34,884
FROM WORK OR COSTS ASSOCIATED 

515
00:20:34,884 --> 00:20:36,753
WITH TRAVEL, ET CETERA. 

516
00:20:36,753 --> 00:20:38,688
REIMBURSEMENT CAN ALSO MAKE 

517
00:20:38,688 --> 00:20:41,157
PARTICIPATION MORE OR LESS 

518
00:20:41,157 --> 00:20:42,759
REVENUE-NEUTRAL FOR PARTICIPANTS

519
00:20:42,759 --> 00:20:46,729
SO THEY DON'T END UP HAVING -- 

520
00:20:46,729 --> 00:20:49,365
BEING S WERE OFF FINANCIALLY 

521
00:20:49,365 --> 00:20:51,901
THAN PARTICIPATING IN THE STUDY.

522
00:20:51,901 --> 00:20:54,971
PAYING PEOPLE CAN ALSO 

523
00:20:54,971 --> 00:20:56,539
COMPENSATE THEM FOR TIME, 

524
00:20:56,539 --> 00:21:00,343
CONTRIBUTION AND RISK, OUT OF 

525
00:21:00,343 --> 00:21:01,778
RESPECT OF APPRECIATION FOR WHAT

526
00:21:01,778 --> 00:21:03,513
THEIR TIME CONTRIBUTION IS. IT 

527
00:21:03,513 --> 00:21:05,081
CAN ALSO MINIMIZE THE 

528
00:21:05,081 --> 00:21:06,182
POSSIBILITY OF EXPLOITING PEOPLE

529
00:21:06,182 --> 00:21:08,818
BY GIVING THEM MORE BENEFITS AND

530
00:21:08,818 --> 00:21:10,520
CAN DEMONSTRATE RESPECT AND 

531
00:21:10,520 --> 00:21:14,457
GRATITUDE FOR THEIR 

532
00:21:14,457 --> 00:21:16,025
PARTICIPATION. THESE ARE ALL OF 

533
00:21:16,025 --> 00:21:18,094
COURSE NOT MUTUALLY EXCLUSIVE 

534
00:21:18,094 --> 00:21:19,762
AND MAYBE ANY OF THESE REASONS 

535
00:21:19,762 --> 00:21:21,598
COULD ALSO FACILITATE 

536
00:21:21,598 --> 00:21:22,198
RECRUITMENT. IN OTHER WORDS, 

537
00:21:22,198 --> 00:21:26,136
PEOPLE ARE MORE LIKELY TO ENROLL

538
00:21:26,136 --> 00:21:28,338
IF PARTICIPATION IS 

539
00:21:28,338 --> 00:21:31,341
REVENUE-NEUTRAL FOR THEM. WHAT 

540
00:21:31,341 --> 00:21:33,042
ARE THE CONCERNS? WHAT ARE THE 

541
00:21:33,042 --> 00:21:33,910
ETHICAL CONCERNS THAT 

542
00:21:33,910 --> 00:21:35,745
CONTINUALLY POP UP IN THE 

543
00:21:35,745 --> 00:21:38,248
DISCUSSION OF PAYING RESEARCH 

544
00:21:38,248 --> 00:21:40,517
PARTICIPANTS? COERCION, UNDUE 

545
00:21:40,517 --> 00:21:43,086
INFLUENCE OR INDUCEMENT, UNJUST 

546
00:21:43,086 --> 00:21:45,655
-- WHAT PEOPLE CALL UNJUST 

547
00:21:45,655 --> 00:21:48,258
INDUCEMENT, EXPLOITATION AND 

548
00:21:48,258 --> 00:21:50,260
DECEPTION ARE THE ONES MOST 

549
00:21:50,260 --> 00:21:53,930
COMMONLY DESCRIBED. SO WHAT 

550
00:21:53,930 --> 00:21:57,500
ABOUT COERCION? COERCION BY 

551
00:21:57,500 --> 00:21:59,969
DEFINITION IS A THREAT. A THREAT

552
00:21:59,969 --> 00:22:01,471
TO MAKE SOMEBODY WORSE OFF BY 

553
00:22:01,471 --> 00:22:04,541
EITHER VIOLATING THEIR RIGHTS OR

554
00:22:04,541 --> 00:22:06,209
DEPRIVING THEM OF SOMETHING THEY

555
00:22:06,209 --> 00:22:08,278
ARE ENTITLED TO. LEAVING THEM IN

556
00:22:08,278 --> 00:22:10,580
A SITUATION WHERE THEY HAVE NO 

557
00:22:10,580 --> 00:22:14,083
REASONABLE ALTERNATIVE BUT TO 

558
00:22:14,083 --> 00:22:17,020
COMPLY WITH THE THREAT. THE SORT

559
00:22:17,020 --> 00:22:19,289
OF CLASSIC EXAMPLE, OF COURSE, 

560
00:22:19,289 --> 00:22:21,224
IS YOUR MONEY OR YOUR LIFE. YOU 

561
00:22:21,224 --> 00:22:23,159
KNOW, YOU HAVE NO RESPECTABLE 

562
00:22:23,159 --> 00:22:25,662
ALTERNATIVE BUT TO GIVE UP YOUR 

563
00:22:25,662 --> 00:22:28,998
MONEY, UNLESS YOU HAVE A DEATH 

564
00:22:28,998 --> 00:22:31,701
WISH OF SOME SORT. MANY AUTHOR S

565
00:22:31,701 --> 00:22:35,438
HAVE ARGUED THAT THE OFFER OF 

566
00:22:35,438 --> 00:22:37,307
PAYMENT MAKES SOMEONE -- OR CAN 

567
00:22:37,307 --> 00:22:39,609
MAKE SOMEONE BETTER OFF, NOT 

568
00:22:39,609 --> 00:22:41,678
WORSE OFF. THEREFORE PAYMENT IS 

569
00:22:41,678 --> 00:22:44,180
NOT COERCIVE. ALL THE TIMES WE 

570
00:22:44,180 --> 00:22:47,150
TALK ABOUT COERCION FROM 

571
00:22:47,150 --> 00:22:49,352
PAYMENT, WE'RE MISSPEAKING. 

572
00:22:49,352 --> 00:22:51,054
COERCION IS NOT THE RIGHT LABEL 

573
00:22:51,054 --> 00:22:53,823
FOR WHAT WE MIGHT WORRY ABOUT 

574
00:22:53,823 --> 00:22:55,825
WITH PAYMENT. WHAT MANY PEOPLE 

575
00:22:55,825 --> 00:22:57,961
DO WORRY ABOUT IS UNDUE 

576
00:22:57,961 --> 00:23:00,396
INFLUENCE OR UNDUE INDUCEMENT. 

577
00:23:00,396 --> 00:23:02,498
THIS IS A LITTLE -- THE 

578
00:23:02,498 --> 00:23:04,334
DEFINITION OF UNDUE INFLUENCE IS

579
00:23:04,334 --> 00:23:07,570
A LITTLE LESS UNIVERSALLY AGREED

580
00:23:07,570 --> 00:23:12,442
TO THAN THAT OF COERCION BUT WE 

581
00:23:12,442 --> 00:23:14,978
ARE GETTING CLOSE, BETTER. 

582
00:23:14,978 --> 00:23:17,747
BASICALLY UNDUE ARE OFFERS WHOSE

583
00:23:17,747 --> 00:23:19,015
ATTRACTIVENESS DISTORT JUDGMENT 

584
00:23:19,015 --> 00:23:20,149
INDUCING THEM TO DO SOMETHING 

585
00:23:20,149 --> 00:23:22,852
THAT IS UNREASONABLE OR 

586
00:23:22,852 --> 00:23:24,687
SOMETHING AGAINST THEIR OWN 

587
00:23:24,687 --> 00:23:25,922
INTERESTS. IT IS THE IDEA OF 

588
00:23:25,922 --> 00:23:27,624
BEING BLINDED BY THE MONEY. SO 

589
00:23:27,624 --> 00:23:29,459
YOU ARE NOT PAYING ATTENTION OR 

590
00:23:29,459 --> 00:23:31,394
DON'T CARE ABOUT WHAT YOU ARE 

591
00:23:31,394 --> 00:23:36,032
BEING ASKED TO DO. IMPORTANTLY, 

592
00:23:36,032 --> 00:23:38,101
INDUCEMENTS ARE PART OF EVERYDAY

593
00:23:38,101 --> 00:23:41,004
LIFE. WE ALL DO THINGS -- WE ARE

594
00:23:41,004 --> 00:23:43,206
ALL INDUCED BY MONEY IN MANY 

595
00:23:43,206 --> 00:23:45,675
CASES TO DO THINGS WE MIGHT NOT 

596
00:23:45,675 --> 00:23:48,511
OTHERWISE DO IF WE WEREN'T BEING

597
00:23:48,511 --> 00:23:50,280
PAID. YET THOSE ARE REASONABLE 

598
00:23:50,280 --> 00:23:52,148
THINGS. THOSE ARE NORMAL 

599
00:23:52,148 --> 00:23:53,983
INDUCEMENTS. THEY ARE NOT UNDUE.

600
00:23:53,983 --> 00:23:55,318
THEY DON'T BLIND US TO WHAT WE 

601
00:23:55,318 --> 00:23:57,520
ARE BEING ASKED TO DO. WE MAKE 

602
00:23:57,520 --> 00:24:00,556
VOLUNTARY DECISIONS TO GO TO 

603
00:24:00,556 --> 00:24:02,925
WORK. BUT WE MIGHT NOT DO THAT 

604
00:24:02,925 --> 00:24:05,228
IF WE WEREN'T PAID FOR WORK. THE

605
00:24:05,228 --> 00:24:07,096
CHALLENGE HERE IS DISCERNING 

606
00:24:07,096 --> 00:24:10,166
WHAT IS AN INDUCEMENT, WHICH 

607
00:24:10,166 --> 00:24:12,201
GIVES SOMEBODY THE INCENTIVE TO 

608
00:24:12,201 --> 00:24:13,770
DO SOMETHING THEY MIGHT NOT 

609
00:24:13,770 --> 00:24:15,605
OTHERWISE DO FROM AN UNDUE 

610
00:24:15,605 --> 00:24:17,173
INDUCEMENT WHICH INDUCES THEM TO

611
00:24:17,173 --> 00:24:20,643
DO SOMETHING THAT IS AGAINST 

612
00:24:20,643 --> 00:24:23,279
THEIR INTERESTS. SACARP, OR 

613
00:24:23,279 --> 00:24:25,214
SECRETARY'S ADVISORY COMMITTEE 

614
00:24:25,214 --> 00:24:29,385
ON HUMAN RESEARCH PROTECTION, 

615
00:24:29,385 --> 00:24:32,955
SECRETARY OF HSS THAT IS 

616
00:24:32,955 --> 00:24:35,458
PUBLISHED RECOMMENDATIONS IN 

617
00:24:35,458 --> 00:24:37,760
2019 PATIENT TO RESEARCH 

618
00:24:37,760 --> 00:24:39,295
PARTICIPANTS. THEY DEFINE UNDUE 

619
00:24:39,295 --> 00:24:42,198
INFLUENCE IN THE FOLLOWING WAY. 

620
00:24:42,198 --> 00:24:44,033
IT OCCURS WHEN THERE IS AN 

621
00:24:44,033 --> 00:24:45,101
EXCESSIVE OFFER OF SOMETHING 

622
00:24:45,101 --> 00:24:48,071
VALUABLE OR DESIRABLE THAT LEADS

623
00:24:48,071 --> 00:24:50,039
TO POOR JUDGMENT OR A 

624
00:24:50,039 --> 00:24:52,241
COMPROMISED DECISION MAKING 

625
00:24:52,241 --> 00:24:53,343
PROGRESS WHICH IN TURN LEADS TO 

626
00:24:53,343 --> 00:24:56,479
DECISION TO ENGAGE IN A HARMFUL 

627
00:24:56,479 --> 00:24:57,747
ACTIVITY THAT SERIOUSLY 

628
00:24:57,747 --> 00:24:59,982
CONTRAVENES DECISION MAKER'S 

629
00:24:59,982 --> 00:25:05,888
INTERESTS OR OBLIGATIONS. THEY 

630
00:25:05,888 --> 00:25:07,990
GO ON TO DESCRIBE -- OTHER 

631
00:25:07,990 --> 00:25:09,325
COMMENTATOR S HAVE DONE THIS IN 

632
00:25:09,325 --> 00:25:11,627
THE LITERATURE-E THAT IN THE 

633
00:25:11,627 --> 00:25:13,162
CONTEXT OF RESEARCH THAT IS ALL 

634
00:25:13,162 --> 00:25:16,132
REVIEWED IN ADVANCE BY AN I R 

635
00:25:16,132 --> 00:25:20,103
B , THE LIKELIHOOD OF THERE 

636
00:25:20,103 --> 00:25:21,971
BEING UNREASONABLY HARMFUL 

637
00:25:21,971 --> 00:25:23,673
ACTIVITY WITH RISKS AND BENEFITS

638
00:25:23,673 --> 00:25:26,109
THAT ARE NOT JUSTIFIED IS VERY 

639
00:25:26,109 --> 00:25:28,578
LOW -- AT LEAST MITIGATED. THAT 

640
00:25:28,578 --> 00:25:30,413
DOESN'T REMOVE THE POSSIBILITY 

641
00:25:30,413 --> 00:25:32,749
THAT AN INDIVIDUAL EITHER 

642
00:25:32,749 --> 00:25:34,050
BECAUSE OF INDIVIDUAL 

643
00:25:34,050 --> 00:25:36,386
SUSCEPTIBILITIES OR SOME KIND OF

644
00:25:36,386 --> 00:25:38,855
SOMETHING ABOUT THE INDIVIDUAL 

645
00:25:38,855 --> 00:25:41,824
CIRCUMSTANCES COULD BE INDUCED 

646
00:25:41,824 --> 00:25:43,726
TO PARTICIPATE IN A STUDY THAT 

647
00:25:43,726 --> 00:25:46,129
IS HARMFUL TO THEM OR THAT 

648
00:25:46,129 --> 00:25:48,564
CONTRAVENES THEIR INTEREST IN A 

649
00:25:48,564 --> 00:25:49,699
CERTAIN WAY. BUT BECAUSE 

650
00:25:49,699 --> 00:25:53,035
RESEARCH IS REVIEWED BY AN IRB, 

651
00:25:53,035 --> 00:25:54,437
THIS CONCERN IS MUCH LESS THAN 

652
00:25:54,437 --> 00:25:55,938
IT MIGHT BE IN OTHER PARTS OF 

653
00:25:55,938 --> 00:26:00,176
THE WORLD, WHERE THINGS ARE NOT 

654
00:26:00,176 --> 00:26:04,480
REVIEWED. SACARP GOES ON TO SAY,

655
00:26:04,480 --> 00:26:06,849
UNDUE INFLUENCE OCCURS WHEN 

656
00:26:06,849 --> 00:26:10,420
APPEARS LIKELY TO PROHIBIT 

657
00:26:10,420 --> 00:26:13,623
ADEQUATE CONSIDERATION OR/AND 

658
00:26:13,623 --> 00:26:15,124
REFLECTION ABOUT IMPORTANT STUDY

659
00:26:15,124 --> 00:26:18,828
FEATURES SUCH AS RISK, BURDEN, 

660
00:26:18,828 --> 00:26:19,729
DISCOMFORTS AND COMPARE 

661
00:26:19,729 --> 00:26:22,465
UNDERSTANDING OF RESEARCH AND 

662
00:26:22,465 --> 00:26:23,299
PARTICIPATION IN IT. SO THERE 

663
00:26:23,299 --> 00:26:25,601
HAVE BEEN A NUMBER OF STUDIES 

664
00:26:25,601 --> 00:26:27,570
HAVE HAVE TRIED TO LOOK AT THIS.

665
00:26:27,570 --> 00:26:31,374
THERE WAS A STUDY CRITER AND ALL

666
00:26:31,374 --> 00:26:33,810
PUBLISHED IN SOCIAL SERVICE 

667
00:26:33,810 --> 00:26:37,780
MEDICINE AND HALPERNS 

668
00:26:37,780 --> 00:26:38,381
INTERNATIONAL MEDICINE FOUND 

669
00:26:38,381 --> 00:26:40,316
HIGH PARTICIPATION PAYMENTS -- 

670
00:26:40,316 --> 00:26:41,951
IN OTHER WORDS, THE MORE MONEY 

671
00:26:41,951 --> 00:26:43,519
YOU GAVE PEOPLE, THE MORE LIKELY

672
00:26:43,519 --> 00:26:45,755
THEY WERE TO PERCEIVE STUDY HAD 

673
00:26:45,755 --> 00:26:48,391
RISK AND THE MORE TIME THEY WERE

674
00:26:48,391 --> 00:26:50,359
-- THE MORE TIME THEY WERE 

675
00:26:50,359 --> 00:26:54,030
LIKELY TO SPEND REVIEWING THE 

676
00:26:54,030 --> 00:26:55,865
RISK INFORMATION. SO IT IS NOT 

677
00:26:55,865 --> 00:26:58,201
-- AT LEAST THOSE DATA SUGGEST 

678
00:26:58,201 --> 00:27:00,636
IT IS NOT THE PEOPLE IGNORE THE 

679
00:27:00,636 --> 00:27:01,938
RISK. THEY ACTUALLY PAY MORE 

680
00:27:01,938 --> 00:27:05,708
ATTENTION TO THEM. WE DID A 

681
00:27:05,708 --> 00:27:08,444
STUDY ABOUT COMPREHENSION AFTER 

682
00:27:08,444 --> 00:27:09,712
INFORMED CONTENT. HAD NOTHING TO

683
00:27:09,712 --> 00:27:12,014
DO WITH -- IT WASN'T 

684
00:27:12,014 --> 00:27:13,316
SPECIFICALLY ABOUT MONEY. BUT 

685
00:27:13,316 --> 00:27:15,184
WHAT WE FOUND IN THAT STUDY WAS 

686
00:27:15,184 --> 00:27:17,720
-- AND THESE WERE HEALTHY 

687
00:27:17,720 --> 00:27:20,089
VOLUNTEERS -- THAT THOSE WHO 

688
00:27:20,089 --> 00:27:23,559
SAID THEIR MAIN MOTIVATION FOR 

689
00:27:23,559 --> 00:27:26,262
PARTICIPATING WAS FINANCIAL HAD 

690
00:27:26,262 --> 00:27:28,664
HIGHER COMPREHENSION SCORE. IN 

691
00:27:28,664 --> 00:27:29,265
OTHER WORDS, UNDERSTOOD MORE 

692
00:27:29,265 --> 00:27:30,833
ABOUT THE STUDY THAN THOSE WHO 

693
00:27:30,833 --> 00:27:34,937
REPORTED OTHER MOTIVATIONS FOR 

694
00:27:34,937 --> 00:27:36,973
PARTICIPATING. WHAT ABOUT STUDY 

695
00:27:36,973 --> 00:27:38,341
RISKS? AGAIN, THERE HAVE BEEN A 

696
00:27:38,341 --> 00:27:43,045
NUMBER OF STUDIES. THIS STUDY BY

697
00:27:43,045 --> 00:27:49,852
BENTLEY AND THACKER THAT MONEY 

698
00:27:49,852 --> 00:27:50,887
INCREASED RESPONDENT'S 

699
00:27:50,887 --> 00:27:53,155
WILLGLINESS -- HYPOTHETICAL 

700
00:27:53,155 --> 00:27:55,525
STUDIES -- REGARDLESS OF RISK. 

701
00:27:55,525 --> 00:27:56,392
IN OTHER WORDS, GIVE THEM MORE 

702
00:27:56,392 --> 00:27:58,561
MONEY THEY WERE MORE WILLING TO 

703
00:27:58,561 --> 00:28:01,163
TAR TIS PATE BUT WILLINGNESS 

704
00:28:01,163 --> 00:28:04,333
DECREASED AS RISK INCREASED. 

705
00:28:04,333 --> 00:28:07,603
THAT WAS NOT AT TEN YOU WAITED 

706
00:28:07,603 --> 00:28:11,941
BY HIGHER PAYMENT. ANOTHER 

707
00:28:11,941 --> 00:28:13,276
STUDY, SIMILAR, THOUGH 

708
00:28:13,276 --> 00:28:15,111
INCREASING PAYMENTS MOTIVATED 

709
00:28:15,111 --> 00:28:17,613
GREATER WILLGLY TO PARTICIPATE, 

710
00:28:17,613 --> 00:28:19,248
PARTICIPATION RATES DROPPED 

711
00:28:19,248 --> 00:28:21,551
EQUIVALENTLY WITH INCREASING 

712
00:28:21,551 --> 00:28:23,486
RISKS ACROSS ALL PAYMENT LEVELS 

713
00:28:23,486 --> 00:28:26,689
SO FOUND ALMOST THE SAME THING 

714
00:28:26,689 --> 00:28:30,326
BENTLEY AND THACKER DID. IN THE 

715
00:28:30,326 --> 00:28:32,061
STUDY I DESCRIBED WITH HEALTHY 

716
00:28:32,061 --> 00:28:34,030
VOLUNTEER WHO'S VOLUNTEERED FOR 

717
00:28:34,030 --> 00:28:35,364
PHASE I DRUG STUDIES WITH PFIZER

718
00:28:35,364 --> 00:28:36,899
THEY RATED RISK AS MORE 

719
00:28:36,899 --> 00:28:38,334
IMPORTANT TO ENROLLMENT DECISION

720
00:28:38,334 --> 00:28:40,303
THAN MONEY WAS. SO THEY PAID 

721
00:28:40,303 --> 00:28:42,538
ATTENTION TO RISK. IN FACT, 

722
00:28:42,538 --> 00:28:44,006
ANOTHER THING THEY CARED ABOUT A

723
00:28:44,006 --> 00:28:46,976
LOT WAS THE AMOUNT OF TIME THEY 

724
00:28:46,976 --> 00:28:51,414
HAD TO SPEND THERE AND DEGREE OF

725
00:28:51,414 --> 00:28:52,048
SORREN

726
00:28:52,048 --> 00:28:53,149
SORT OF DISCOMFORT OR THINGS 

727
00:28:53,149 --> 00:28:54,951
THEY HAD TO DO. JILL FISCHER WHO

728
00:28:54,951 --> 00:28:57,920
HAS DONE A LOT OF STUDIES WITH 

729
00:28:57,920 --> 00:29:02,158
HEALTHY VOLUNTEERS HAS IN THIS 

730
00:29:02,158 --> 00:29:04,927
ONE PAPER SHE PUBLISHED IN 2018 

731
00:29:04,927 --> 00:29:05,528
FOUND HEALTHY VOLUNTEERS ARE 

732
00:29:05,528 --> 00:29:08,097
GENERALLY QUITE AWARE OF AND 

733
00:29:08,097 --> 00:29:10,166
REFLECTIVE ABOUT PHASE I TRIAL 

734
00:29:10,166 --> 00:29:11,834
RISKS. THE MAJORITY THOUGHT 

735
00:29:11,834 --> 00:29:14,070
TRIALS WERE OF MEDIUM-HIGH OR 

736
00:29:14,070 --> 00:29:16,138
EXTREMELY HIGH RISK. NONETHELESS

737
00:29:16,138 --> 00:29:18,741
FELT THEY WERE PERSONALLY SAFE 

738
00:29:18,741 --> 00:29:20,743
FROM HARM AND THEREFORE WILLING 

739
00:29:20,743 --> 00:29:23,312
TO PARTICIPATE. WHAT ABOUT 

740
00:29:23,312 --> 00:29:25,815
UNJUST INDUCEMENT? UNJUST 

741
00:29:25,815 --> 00:29:27,783
INDUCEMENT MEANS IF WE ARE 

742
00:29:27,783 --> 00:29:30,319
PAYING PEOPLE, IT WILL INCREASE 

743
00:29:30,319 --> 00:29:31,721
THE EXTENT TO WHICH RESEARCH 

744
00:29:31,721 --> 00:29:34,924
RELIES ON THE POOR, WHICH BOTH 

745
00:29:34,924 --> 00:29:38,060
IS PROBLEMATIC FOR 

746
00:29:38,060 --> 00:29:42,031
GENERAL IZABILITY BUT ALSO FOR 

747
00:29:42,031 --> 00:29:42,665
DISPROPORTIONATELY PUTTING THE 

748
00:29:42,665 --> 00:29:44,433
BURDEN OF RESEARCH ON PEOPLE WHO

749
00:29:44,433 --> 00:29:48,170
ARE LESS WELL-RESOURCED. THERE 

750
00:29:48,170 --> 00:29:50,473
HAVE BEEN A COUPLE STUDIES, NOT 

751
00:29:50,473 --> 00:29:54,610
AS MANY, BUT THE TWO I'M CITING 

752
00:29:54,610 --> 00:29:57,680
BASICALLY TRY TO DEBUNK THIS AND

753
00:29:57,680 --> 00:30:02,785
SAY -- THE HALPERIN STUDY IN 

754
00:30:02,785 --> 00:30:04,487
2004 FOUND POSITIVE CONNECTION 

755
00:30:04,487 --> 00:30:06,589
BETWEEN INCOME AND MONEY ON 

756
00:30:06,589 --> 00:30:08,457
WILLGLY TO PARTICIPATE. BUT WHAT

757
00:30:08,457 --> 00:30:10,793
THEY FOUND WAS PAYMENT HAD A 

758
00:30:10,793 --> 00:30:12,328
STRONGER INFLUENCE AMONG PEOPLE 

759
00:30:12,328 --> 00:30:15,831
WHO MADE MORE MONEY, WHO WERE 

760
00:30:15,831 --> 00:30:16,832
WEALTHIER RATHER THAN THE 

761
00:30:16,832 --> 00:30:22,838
OPPOSITE. THIS OTHER STUDY DONE 

762
00:30:22,838 --> 00:30:29,812
LOOKING AT COVID STUDY SAID IT 

763
00:30:29,812 --> 00:30:33,315
HAD LITTLE IMPACT ON POORER 

764
00:30:33,315 --> 00:30:33,983
INDIVIDUALS. IN OTHER WORDS, IT 

765
00:30:33,983 --> 00:30:38,688
HAD -- PEOPLE WHO WERE LESS WELL

766
00:30:38,688 --> 00:30:40,956
RESOURCED WERE NOT LIKELY TO 

767
00:30:40,956 --> 00:30:44,360
PARTICIPATE WITH SMALL 

768
00:30:44,360 --> 00:30:45,961
INCENTIVES BECAUSE THEY WERE 

769
00:30:45,961 --> 00:30:48,030
HESITANT ABOUT THE STUDY MORE 

770
00:30:48,030 --> 00:30:49,265
THAN BECAUSE THE MONEY WASN'T 

771
00:30:49,265 --> 00:30:51,233
THAT GREAT. ONCE THE INCENTIVES 

772
00:30:51,233 --> 00:30:55,004
GOT LARGER, MORE PEOPLE WERE 

773
00:30:55,004 --> 00:30:57,206
WILLING TO PARTICIPATE ACROSS 

774
00:30:57,206 --> 00:31:01,177
INCOME LEVELS, SORRY. WHAT ABOUT

775
00:31:01,177 --> 00:31:03,479
EXPLOITATION? SO EXPLOITATION IS

776
00:31:03,479 --> 00:31:06,615
THOUGHT OF AS TAKING UNFAIR 

777
00:31:06,615 --> 00:31:10,252
ADVANTAGE OF PEOPLE. MEANING IN 

778
00:31:10,252 --> 00:31:12,755
RESEARCH WHEN THE PARTICIPANTS 

779
00:31:12,755 --> 00:31:14,657
DO NOT RECEIVE BENEFITS THAT ARE

780
00:31:14,657 --> 00:31:16,892
FAIR, GIVEN THE RISKS OR BURDENS

781
00:31:16,892 --> 00:31:18,594
THAT THEY ASSUME AND THE EXTENT 

782
00:31:18,594 --> 00:31:20,830
TO WHICH OTHERS ARE BENEFIT ING 

783
00:31:20,830 --> 00:31:22,298
FROM THEIR INVOLVEMENT, THAT IS 

784
00:31:22,298 --> 00:31:25,868
THE DEFINITION OF EXPLOITATION 

785
00:31:25,868 --> 00:31:27,103
THAT'S BEEN AROUND FOR SOME 

786
00:31:27,103 --> 00:31:30,940
TIME. MANY HAVE ARGUED THAT 

787
00:31:30,940 --> 00:31:32,308
PAYMENT MIGHT ACTUALLY INCREASE 

788
00:31:32,308 --> 00:31:35,044
THE EXTENT TO WHICH PARTICIPANTS

789
00:31:35,044 --> 00:31:37,079
BENEFIT. THEREFORE REDUCING THE 

790
00:31:37,079 --> 00:31:39,815
CHANCES OF EXPLOITATION, NOT 

791
00:31:39,815 --> 00:31:42,017
INCREASING IT. PEOPLE WHO ARGUE 

792
00:31:42,017 --> 00:31:43,819
THIS SAY WE SHOULD BE PAYING 

793
00:31:43,819 --> 00:31:46,522
PEOPLE MORE. THAT IF WE ARE NOT 

794
00:31:46,522 --> 00:31:49,625
PAYING THEM AT ALL OR IF WE ARE 

795
00:31:49,625 --> 00:31:56,398
PAYING THEM TOO LOW THAT, IS 

796
00:31:56,398 --> 00:31:59,969
MORE EXPLOITIVE. LAST ON MY 

797
00:31:59,969 --> 00:32:03,873
POSSIBLE LIST OF CONCERNS IS 

798
00:32:03,873 --> 00:32:05,941
DECEPTION. THIS IS SOMETHING 

799
00:32:05,941 --> 00:32:08,811
THAT -- THERE WAS A STUDY IN 

800
00:32:08,811 --> 00:32:11,147
2013 IN CLINICAL TRIALS THAT 

801
00:32:11,147 --> 00:32:12,882
FOUND OUT OF 100 PARTICIPANTS IN

802
00:32:12,882 --> 00:32:15,451
AT LEAST TWO TRIALS, ALMOST A 

803
00:32:15,451 --> 00:32:18,320
THIRD CONCEALED THEIR HEALTH 

804
00:32:18,320 --> 00:32:20,923
PROBLEMS. 28% CONCEALED 

805
00:32:20,923 --> 00:32:22,391
MEDICATIONS. 14% PRETENDED TO 

806
00:32:22,391 --> 00:32:25,394
HAVE A CONDITION THEY DIDN'T 

807
00:32:25,394 --> 00:32:27,563
HAVE. THIS WAS -- THIS TENDENCY 

808
00:32:27,563 --> 00:32:29,932
TO CONCEAL WAS CORRELATED WITH A

809
00:32:29,932 --> 00:32:32,067
GREATER INTEREST IN MONETARY 

810
00:32:32,067 --> 00:32:34,570
AWARDS. THIS IS PROBLEMATIC. 

811
00:32:34,570 --> 00:32:37,039
NEIL DICKERT WHO WORKED WITH ME 

812
00:32:37,039 --> 00:32:39,008
A LONG TIME AGO ON ISSUES 

813
00:32:39,008 --> 00:32:40,442
RELATED TO PAYMENT IN A 

814
00:32:40,442 --> 00:32:42,311
COMMENTARY SAID INCENTIVE 

815
00:32:42,311 --> 00:32:43,813
PAYMENTS MAY LEAD PARTICIPANTS 

816
00:32:43,813 --> 00:32:45,114
TO LIE ABOUT THEIR HISTORY IN 

817
00:32:45,114 --> 00:32:47,082
ORDER TO BE ELIGIBLE OR DENY 

818
00:32:47,082 --> 00:32:48,584
SIDE EFFECTS TO AVOID BEING 

819
00:32:48,584 --> 00:32:50,986
DROPPED. THIS IS SOMETHING WE DO

820
00:32:50,986 --> 00:32:52,988
NEED TO PAY ATTENTION TO. IT WAS

821
00:32:52,988 --> 00:32:56,392
AN INTERESTING PEOPLE IN THE DMJ

822
00:32:56,392 --> 00:32:59,662
JUST ABOUT A MONTH AGO ACTUALLY.

823
00:32:59,662 --> 00:33:01,263
BASICALLY YOU CAN SEE THE TITLE,

824
00:33:01,263 --> 00:33:04,567
WHEN SCIENCE GOES WRONG, 

825
00:33:04,567 --> 00:33:05,701
MISREPRESENTATION, COERCION, 

826
00:33:05,701 --> 00:33:08,504
UNDUE INFLUENCE IN PAYING 

827
00:33:08,504 --> 00:33:12,107
RESEARCH PARTICIPANTS. THIS IS 

828
00:33:12,107 --> 00:33:12,441
INTERESTING .

829
00:33:12,441 --> 00:33:14,310
THE PREVIOUS WORK HAD SHOWN 

830
00:33:14,310 --> 00:33:16,579
ELEVATED MERCURY LEVELS IN URINE

831
00:33:16,579 --> 00:33:21,851
OF MINORS FROM A MINE IN 

832
00:33:21,851 --> 00:33:22,685
ZIMBABWE. THIS TIME HOWEVER IN 

833
00:33:22,685 --> 00:33:25,287
THIS STUDY SHE IS REPORTING ON 

834
00:33:25,287 --> 00:33:28,557
DESPITE INCREASE IN MINING 

835
00:33:28,557 --> 00:33:30,626
ACTIVITY IN THE COUNTRY THE 

836
00:33:30,626 --> 00:33:32,494
AVERAGE MERCURY LEVELS WERE 

837
00:33:32,494 --> 00:33:34,163
LOWER. WHEN THE INVESTIGATIVE 

838
00:33:34,163 --> 00:33:36,665
TEAM WERE CONFUSED. HOW CAN THAT

839
00:33:36,665 --> 00:33:38,200
POSSIBLY BE? WELL, WHEN THEY 

840
00:33:38,200 --> 00:33:39,735
LOOKED THEY REALIZED WHAT 

841
00:33:39,735 --> 00:33:42,671
HAPPENED. THEY WERE PAYING A 

842
00:33:42,671 --> 00:33:46,175
COMPENSATION PAYMENT OF $5. NOT 

843
00:33:46,175 --> 00:33:48,244
VERY MUCH, RIGHT. BUT THAT 

844
00:33:48,244 --> 00:33:51,714
AMOUNT OF MONEY ATTRACTED PEOPLE

845
00:33:51,714 --> 00:33:53,716
FROM OFFICES. SALARIED WORKERS 

846
00:33:53,716 --> 00:33:55,384
FROM THE DOWNTOWN OFFICES. NOT 

847
00:33:55,384 --> 00:33:57,653
JUST MINORS, SO THEREFORE 

848
00:33:57,653 --> 00:33:59,622
DISTORTED THE POPULATION THAT 

849
00:33:59,622 --> 00:34:01,957
THEY WERE STUDYING. THOSE PEOPLE

850
00:34:01,957 --> 00:34:04,226
HAD MISREPRESENTED THEMSELVES AS

851
00:34:04,226 --> 00:34:05,828
MINORS IN ORDER TO ACCESS THE 

852
00:34:05,828 --> 00:34:07,263
PAYMENT. SOMETHING THAT DIDN'T 

853
00:34:07,263 --> 00:34:09,732
HAPPEN THE PREVIOUS TIME WHEN 

854
00:34:09,732 --> 00:34:11,433
THEY HAD DONE THE STUDY AT THE 

855
00:34:11,433 --> 00:34:14,436
MINE AND NOT IN THE TOWN. VERY 

856
00:34:14,436 --> 00:34:15,771
INTERESTING LESSON IN THE 

857
00:34:15,771 --> 00:34:18,240
DETAILS OF WHERE THE STUDY IS 

858
00:34:18,240 --> 00:34:19,675
DONE, WHAT THE STUDY IS ABOUT, 

859
00:34:19,675 --> 00:34:22,978
WHO THE PARTICIPANTS MIGHT BE 

860
00:34:22,978 --> 00:34:24,813
ARE IMPORTANT. WE NEED TO PAY 

861
00:34:24,813 --> 00:34:26,749
ATTENTION TO THOSE THINGS TO 

862
00:34:26,749 --> 00:34:30,052
MINIMIZE THE POSSIBILITY OF 

863
00:34:30,052 --> 00:34:31,854
REPRESENTATION. ERIC DEVINE AND 

864
00:34:31,854 --> 00:34:35,791
COLLEAGUES, WHO DID THAT PRIOR 

865
00:34:35,791 --> 00:34:37,293
STUDY ON MISREPRESENTATION, HAVE

866
00:34:37,293 --> 00:34:40,629
A PAPER IN CONTEMPORARY CLINICAL

867
00:34:40,629 --> 00:34:42,765
TRIALS IN 2017 WHERE THEY HAVE A

868
00:34:42,765 --> 00:34:47,002
SERIES OF SUGGESTIONS ABOUT 

869
00:34:47,002 --> 00:34:48,871
STRATEGIES TO REDUCE THIS 

870
00:34:48,871 --> 00:34:51,907
POSSIBILITY OR THIS PROBLEM OF 

871
00:34:51,907 --> 00:34:52,608
MISREPRESENTATION. BASICALLY 

872
00:34:52,608 --> 00:34:55,277
THEY SAY TO EXCLUDE SUBJECTS WHO

873
00:34:55,277 --> 00:34:57,913
CONCEAL AND FABRICATE 

874
00:34:57,913 --> 00:34:59,415
INFORMATION. THEIR STRATEGIES 

875
00:34:59,415 --> 00:35:01,750
INCLUDE HOW YOU WRITE THE 

876
00:35:01,750 --> 00:35:02,685
ADVERTISEMENTS, HOW MUCH MONEY 

877
00:35:02,685 --> 00:35:04,353
YOU ACTUALLY OFFER, THE 

878
00:35:04,353 --> 00:35:05,788
SCREENING PROCESS AND WHAT 

879
00:35:05,788 --> 00:35:07,389
QUESTIONS YOU ASK PEOPLE, HOW 

880
00:35:07,389 --> 00:35:11,193
YOU ASSESS PARTICIPANT'S 

881
00:35:11,193 --> 00:35:13,829
MOTIVATIONS. PAYING ATTENTION TO

882
00:35:13,829 --> 00:35:15,164
INCONSISTENCIES IN 

883
00:35:15,164 --> 00:35:18,367
HISTORY-TAKING OR REPORTS. ALSO 

884
00:35:18,367 --> 00:35:20,903
USING SUBJECT REGISTRIES TO SEE 

885
00:35:20,903 --> 00:35:24,006
IF PEOPLE ARE PARTICIPATING IN 

886
00:35:24,006 --> 00:35:24,907
MULTIPLE TRIALS AT THE SAME 

887
00:35:24,907 --> 00:35:26,342
TIME. I THINK ONE OF THE THINGS 

888
00:35:26,342 --> 00:35:28,177
WE DON'T KNOW ABOUT -- THIS IS 

889
00:35:28,177 --> 00:35:29,345
SOMETHING THAT WOULD BE REALLY 

890
00:35:29,345 --> 00:35:31,080
INTERESTING TO STUDY, IF THERE 

891
00:35:31,080 --> 00:35:34,616
WAS A WAY TO STUDY IT, IS 

892
00:35:34,616 --> 00:35:37,286
WHETHER AND TO WHAT EXTENT 

893
00:35:37,286 --> 00:35:38,253
PEOPLE MISREPRESENT THEMSELVES 

894
00:35:38,253 --> 00:35:42,424
IN OTHER TRIALS. WHAT I MEAN BY 

895
00:35:42,424 --> 00:35:45,194
THAT IS I THINK SOMETIMES THERE 

896
00:35:45,194 --> 00:35:47,796
IS A VERY STRONG DESIRE TO 

897
00:35:47,796 --> 00:35:48,897
PARTICIPATE IN A SPECIFIC KIND 

898
00:35:48,897 --> 00:35:51,300
OF TRIAL. ESPECIALLY TRIALS OF 

899
00:35:51,300 --> 00:35:54,503
CERTAIN NEW THERAPIES FOR 

900
00:35:54,503 --> 00:35:57,973
DEVASTATING DISEASES. I THINK IT

901
00:35:57,973 --> 00:35:59,141
IS POSSIBLE THAT PEOPLE WHO WANT

902
00:35:59,141 --> 00:36:01,543
TO PARTICIPATE IN THOSE TRIALS 

903
00:36:01,543 --> 00:36:04,580
MIGHT NOT TELL THE WHOLE STORY 

904
00:36:04,580 --> 00:36:06,949
ABOUT THE MEDICATIONS THEY ARE 

905
00:36:06,949 --> 00:36:09,785
ON, CO MORBIDITIES OR WHATEVER, 

906
00:36:09,785 --> 00:36:11,620
BECAUSE THEY WANT TO BE IN THE 

907
00:36:11,620 --> 00:36:15,524
TRIAL SO BADLY. SO THIS IS A -- 

908
00:36:15,524 --> 00:36:18,060
I DON'T HAVE DA TO SUPPORT THAT,

909
00:36:18,060 --> 00:36:20,362
BUT I THINK IT IS -- INTUITIVELY

910
00:36:20,362 --> 00:36:23,532
IT MAKES SENSE. IT IS HOW MUCH 

911
00:36:23,532 --> 00:36:26,101
YOU WANT SOMETHING. YOU ARE 

912
00:36:26,101 --> 00:36:28,437
WILLING SOMETIMES TO 

913
00:36:28,437 --> 00:36:30,339
MISREPRESENT YOU'RE TO GET IT. 

914
00:36:30,339 --> 00:36:32,875
THE ZIMBABWE STORY WAS, YOU 

915
00:36:32,875 --> 00:36:34,843
KNOW, $5, VERY EASY STUDY. ALL 

916
00:36:34,843 --> 00:36:37,746
YOU HAVE TO DO IS GIVE URINE. 

917
00:36:37,746 --> 00:36:40,182
EASY TO SAY, OH SURE. I'M A 

918
00:36:40,182 --> 00:36:43,952
MINOR. I WANT TO PARTICIPATE IN 

919
00:36:43,952 --> 00:36:46,622
THAT STUDY. SO HAVING SUMMARIZED

920
00:36:46,622 --> 00:36:48,524
SOME OF THE ETHICAL CONCERNS I 

921
00:36:48,524 --> 00:36:50,559
THINK HERE ARE THE THINGS I 

922
00:36:50,559 --> 00:36:53,729
WOULD CONCLUDE. MONEY IS NOT 

923
00:36:53,729 --> 00:36:55,397
COERCIVE. WE PROBABLY WORRY TOO 

924
00:36:55,397 --> 00:36:57,366
MUCH ABOUT UNDUE INFLUENCE. 

925
00:36:57,366 --> 00:37:00,069
OFTEN PEOPLE OFTEN MAKE RATIONAL

926
00:37:00,069 --> 00:37:01,837
DECISIONS TO ACCEPT MORE RISK 

927
00:37:01,837 --> 00:37:03,472
FOR MORE MONEY BUT THAT DOESN'T 

928
00:37:03,472 --> 00:37:05,007
NECESSARILY BLIND THEM TO THE 

929
00:37:05,007 --> 00:37:07,709
RISK. WE STILL HAVE TO REMEMBER 

930
00:37:07,709 --> 00:37:09,011
THAT OTHERS HAVE DIFFERENT 

931
00:37:09,011 --> 00:37:11,713
MOTIVATIONS FOR PARTICIPATING IN

932
00:37:11,713 --> 00:37:12,381
RESEARCH. IN OTHER WORDS, SOME 

933
00:37:12,381 --> 00:37:14,650
PEOPLE WHO WANT THE EXPERIMENTAL

934
00:37:14,650 --> 00:37:17,820
DRUG THAT IS PROMISING FOR THEIR

935
00:37:17,820 --> 00:37:18,854
CONDITION, THEY MAY NOT CARE 

936
00:37:18,854 --> 00:37:20,589
THAT MUCH ABOUT THE MONEY THAT 

937
00:37:20,589 --> 00:37:22,224
IS BEING OFFERED, IF MONEY IS 

938
00:37:22,224 --> 00:37:23,826
BEING OFFERED, OTHER THAN IT 

939
00:37:23,826 --> 00:37:25,194
MIGHT ENABLE THEM TO PARTICIPATE

940
00:37:25,194 --> 00:37:27,296
IN A STUDY. I THINK WE SHOULD 

941
00:37:27,296 --> 00:37:29,465
WORRY LESS THAN WE DO ABOUT 

942
00:37:29,465 --> 00:37:32,601
UNDUE INFLUENCE. I THINK THE 

943
00:37:32,601 --> 00:37:35,971
VARIATION IN THE POPULATION 

944
00:37:35,971 --> 00:37:39,842
DISTRIBUTION OF RESEARCH RISK 

945
00:37:39,842 --> 00:37:42,644
AND BENEFIT, WHAT SOME CALL 

946
00:37:42,644 --> 00:37:44,079
UNJUST INDUCEMENT, IS DRIVEN BY 

947
00:37:44,079 --> 00:37:46,615
A LOT OF FACTORS. MONEY DOESN'T 

948
00:37:46,615 --> 00:37:48,784
APPEAR TO BE THE MAIN THING THAT

949
00:37:48,784 --> 00:37:52,254
MAKES DIFFERENCES IN 

950
00:37:52,254 --> 00:37:55,290
SOCIOECONOMIC CHARACTERISTICS IN

951
00:37:55,290 --> 00:37:57,326
POPULATIONS. WHAT I MEAN BY THAT

952
00:37:57,326 --> 00:38:02,331
IS, IF YOU LOOK AT CANCER TRIALS

953
00:38:02,331 --> 00:38:04,099
AND SOCIAL OWE DEMOGRAPHICS OF 

954
00:38:04,099 --> 00:38:05,968
PEOPLE WHO PARTICIPATE IN CANCER

955
00:38:05,968 --> 00:38:10,172
TRIAL, THEY ARE PREDOMINANTLY 

956
00:38:10,172 --> 00:38:12,841
WHITE, MIDDLE CLASS, INSURED 

957
00:38:12,841 --> 00:38:14,443
INDIVIDUALS. IF YOU LOOK AT 

958
00:38:14,443 --> 00:38:15,777
POPULATIONS THAT PARTICIPATE -- 

959
00:38:15,777 --> 00:38:19,081
THEY ARE NOT BEING OFFERED 

960
00:38:19,081 --> 00:38:21,083
PAYMENT. IF YOU LOOK AT 

961
00:38:21,083 --> 00:38:22,851
POPULATIONS THAT PARTICIPATE IN 

962
00:38:22,851 --> 00:38:25,721
OTHER KINDS OF TRIALS, THEY ARE 

963
00:38:25,721 --> 00:38:27,322
SIMILAR TO WHAT I HAVE JUST 

964
00:38:27,322 --> 00:38:28,690
DESCRIBED. IF YOU LOOK AT 

965
00:38:28,690 --> 00:38:31,193
HEALTHY VOLUNTEERS PRIMARILY 

966
00:38:31,193 --> 00:38:34,196
DRIVEN BY -- MOTIVATED, EXCUSE 

967
00:38:34,196 --> 00:38:38,767
ME, BY MONEY, WE SEE MUCH MORE 

968
00:38:38,767 --> 00:38:40,402
REPRESENTATION OF DIFFERENT 

969
00:38:40,402 --> 00:38:42,905
RACIAL AND ETHNIC GROUPS THAN WE

970
00:38:42,905 --> 00:38:45,741
DO IN SOME CLINICAL TRIALS. BUT 

971
00:38:45,741 --> 00:38:48,143
THEY ALSO HAVE NO OTHER 

972
00:38:48,143 --> 00:38:52,014
MOTIVATION TO PARTICIPATE IN A 

973
00:38:52,014 --> 00:38:55,751
TRIAL OTHER THAN PERHAPS MAKING 

974
00:38:55,751 --> 00:38:57,953
MONEY OR PERHAPS CURIOSITY, 

975
00:38:57,953 --> 00:39:00,489
KNOWLEDGE OR AL TRUISM. I THINK 

976
00:39:00,489 --> 00:39:02,758
WE NEED TO TAKE TAKES TO 

977
00:39:02,758 --> 00:39:04,626
MINIMIZE POSSIBILITY OF 

978
00:39:04,626 --> 00:39:05,928
MISREPRESENTATION IN CLINICAL 

979
00:39:05,928 --> 00:39:07,763
TRIALS. AS I JUST ALLUDED TO 

980
00:39:07,763 --> 00:39:10,032
MAYBE ACROSS THE BOARD. NOT JUST

981
00:39:10,032 --> 00:39:11,967
IN TRIALS THAT OFFER MONEY. WE 

982
00:39:11,967 --> 00:39:13,735
ALSO ALWAYS SHOULD DO OUR BEST 

983
00:39:13,735 --> 00:39:15,804
TO MAXIMIZE PARTICIPANT 

984
00:39:15,804 --> 00:39:20,108
UNDERSTANDING ACROSS STUDIES. 

985
00:39:20,108 --> 00:39:21,009
AGAIN, REGARDLESS OF WHETHER 

986
00:39:21,009 --> 00:39:26,715
PAYMENT IS BEING OFFERED OR NOT.

987
00:39:26,715 --> 00:39:29,284
TO THE LAST PART I WANT TO TURN 

988
00:39:29,284 --> 00:39:30,986
TO, HOW MUCH DO WE FIGURE OUT 

989
00:39:30,986 --> 00:39:33,956
HOW MUCH TO PAY PARTICIPANTS. 

990
00:39:33,956 --> 00:39:35,357
THIS IS SOMETHING THAT IF WE 

991
00:39:35,357 --> 00:39:40,596
LOOK AT STUDIES THAT DO PAY, 

992
00:39:40,596 --> 00:39:42,231
THERE'S A WIDE VARIETY IN TERMS 

993
00:39:42,231 --> 00:39:43,899
OF AMOUNTS. THERE ARE 

994
00:39:43,899 --> 00:39:45,667
DIFFERENCES FROM INSTITUTION TO 

995
00:39:45,667 --> 00:39:47,202
INSTITUTION. SOMETIMES 

996
00:39:47,202 --> 00:39:48,704
DIFFERENCES WITHIN A 

997
00:39:48,704 --> 00:39:51,873
MULTI CENTER STUDY ON THE SAME 

998
00:39:51,873 --> 00:39:53,842
STUDY. O THERE ARE VARIATIONS IN

999
00:39:53,842 --> 00:39:57,679
HOW MUCH PAYMENT IS OFFERED TO 

1000
00:39:57,679 --> 00:39:59,681
PEOPLE AND NOT ENTIRELY CLEAR 

1001
00:39:59,681 --> 00:40:02,651
ALWAYS HOW THE NUMBERS ARE COME 

1002
00:40:02,651 --> 00:40:05,020
UP WITH. YEARS AGO NEIL DICKERT 

1003
00:40:05,020 --> 00:40:08,991
AND I PROPOSED THERE WERE MAYBE 

1004
00:40:08,991 --> 00:40:12,461
THREE MODELS OF PAYING RESEARCH 

1005
00:40:12,461 --> 00:40:13,895
PARTICIPANTS THAT COULD HELP US 

1006
00:40:13,895 --> 00:40:15,497
FIGURE HOW MUCH TO PAY. ONE WAS 

1007
00:40:15,497 --> 00:40:18,333
A MARKET MODEL, LIKE AN 

1008
00:40:18,333 --> 00:40:20,535
INCENTIVE PAYMENT. THAT WOULD BE

1009
00:40:20,535 --> 00:40:23,905
DRIVEN BY THE MARKET, SUPPLY AND

1010
00:40:23,905 --> 00:40:25,507
DEMAND AND HOW MUCH -- HOW 

1011
00:40:25,507 --> 00:40:27,709
QUICKLY YOU WANTED TO ENROLL. 

1012
00:40:27,709 --> 00:40:31,346
THE WAGE PAYMENT MODEL WAS MORE 

1013
00:40:31,346 --> 00:40:34,850
LIKE A WORKING WAGE RECRUITING 

1014
00:40:34,850 --> 00:40:37,119
PEOPLE -- SORRY, PAYING PEOPLE 

1015
00:40:37,119 --> 00:40:41,590
BASED ON THE SORT OF UNSKILL AID

1016
00:40:41,590 --> 00:40:45,127
LOR THAT CONTRIBUTE TO 

1017
00:40:45,127 --> 00:40:46,328
PARTICIPATION IN RESEARCH. THAT 

1018
00:40:46,328 --> 00:40:48,363
WOULD BE PROBABLY TIME AND 

1019
00:40:48,363 --> 00:40:51,099
INCONVENIENCE , THE WAY WE HAVE 

1020
00:40:51,099 --> 00:40:53,201
OFTEN THOUGHT ABOUT PAYING 

1021
00:40:53,201 --> 00:40:55,704
PEOPLE THROUGH THIS MODEL. 

1022
00:40:55,704 --> 00:40:56,638
REIMBURSEMENT IS BASICALLY 

1023
00:40:56,638 --> 00:40:59,941
REIMBURSING PEOPLE FOR EXPENSES.

1024
00:40:59,941 --> 00:41:03,245
THIS IS SOMETHING THAT PEOPLE DO

1025
00:41:03,245 --> 00:41:04,413
DEBATE BECAUSE THEY COULD BE 

1026
00:41:04,413 --> 00:41:07,783
JUST EXPENSES YOU HAVE RECEIVES 

1027
00:41:07,783 --> 00:41:09,818
FOR OR TRAVEL AND FOOD AND 

1028
00:41:09,818 --> 00:41:11,787
LODGING OR CAN BE LOST WAGES AND

1029
00:41:11,787 --> 00:41:13,955
CHILD CARE AND ALL KINDS OF 

1030
00:41:13,955 --> 00:41:16,658
THINGS. SO THERE IS STILL SOME 

1031
00:41:16,658 --> 00:41:17,993
DISCREPANCY ABOUT HOW PEOPLE 

1032
00:41:17,993 --> 00:41:19,461
THINK ABOUT REIMBURSEMENT. IF WE

1033
00:41:19,461 --> 00:41:23,031
LOOK AT THE GUIDELINES AT THE 

1034
00:41:23,031 --> 00:41:28,737
NIH YOU CAN SEE THEY USE ALL 

1035
00:41:28,737 --> 00:41:31,206
THREE OF THESE, REIMBURSEMENT, 

1036
00:41:31,206 --> 00:41:33,375
COMPENSATION AND INCENTIVE AND 

1037
00:41:33,375 --> 00:41:36,378
DESCRIBE THEM, AS I DID, FOR 

1038
00:41:36,378 --> 00:41:37,546
DIFFERENT REASONS. WE PAY PEOPLE

1039
00:41:37,546 --> 00:41:39,548
FOR DIFFERENT REASONS AND HELP 

1040
00:41:39,548 --> 00:41:45,020
YOU TO FIGURE OUT AMOUNTS. IT IS

1041
00:41:45,020 --> 00:41:45,887
INTERESTING THAT SOME PEOPLE 

1042
00:41:45,887 --> 00:41:47,456
HAVE RECOMMEND ED A FOURTH MODEL

1043
00:41:47,456 --> 00:41:52,260
CALLED THE APPRECIATION MODEL. 

1044
00:41:52,260 --> 00:41:53,495
BASICALLY I DON'T THINK IT 

1045
00:41:53,495 --> 00:41:55,764
REALLY SERVES AS A SEPARATE 

1046
00:41:55,764 --> 00:41:57,966
MODEL FOR DETERMINING EITHER 

1047
00:41:57,966 --> 00:41:58,967
REASONS TO PAY OR AMOUNTS TO 

1048
00:41:58,967 --> 00:42:02,738
PAY. IT IS A REASON TO PAY, TO 

1049
00:42:02,738 --> 00:42:05,974
APPRECIATE PEOPLE. BUT IT 

1050
00:42:05,974 --> 00:42:07,442
DOESN'T HELP NECESSARILY WITH 

1051
00:42:07,442 --> 00:42:09,277
AMOUNTS. YOU CAN SHOW 

1052
00:42:09,277 --> 00:42:11,480
APPRECIATION TO A GROUP FOR 

1053
00:42:11,480 --> 00:42:15,083
PARTICIPATING IN YOUR STUDY BY 

1054
00:42:15,083 --> 00:42:20,422
GIVING THEM A $20 STARBUCKS GIFT

1055
00:42:20,422 --> 00:42:22,224
CARD, THAT IS APPRECIATION, BUT 

1056
00:42:22,224 --> 00:42:24,359
NOT DRIVEN BY EXPENSES THEY 

1057
00:42:24,359 --> 00:42:28,997
INCURRED OR INCENTIVES THAT 

1058
00:42:28,997 --> 00:42:33,668
WOULD INCENTIVISE THEM TO 

1059
00:42:33,668 --> 00:42:35,270
PARTICIPATE OR COMPENSATE THEM 

1060
00:42:35,270 --> 00:42:39,241
FOR TIME AND INCONVENIENCE. 

1061
00:42:39,241 --> 00:42:41,176
INTERGLY A STUDY WE DID SOME 

1062
00:42:41,176 --> 00:42:43,879
YEARS AGO LOOKING AT IRB MEMBERS

1063
00:42:43,879 --> 00:42:45,614
ACROSS THE COUNTRY -- THERE WERE

1064
00:42:45,614 --> 00:42:49,851
ABOUT 600 IN OUR STUDY, THE 

1065
00:42:49,851 --> 00:42:52,954
MAJORITY SAID THEY WERE SOMEWHAT

1066
00:42:52,954 --> 00:42:54,623
MODERATELY OR VERY CONCERNED BY 

1067
00:42:54,623 --> 00:42:56,124
PAYING PARTICIPANTS IN ANY 

1068
00:42:56,124 --> 00:42:57,592
AMOUNT. I DON'T KNOW -- THIS IS 

1069
00:42:57,592 --> 00:43:01,563
TEN YEARS AGO. I DON'T KNOW IF 

1070
00:43:01,563 --> 00:43:02,697
IT IS DIFFERENT TODAY BUT I 

1071
00:43:02,697 --> 00:43:05,333
THINK IT WAS SURPRISING IN THAT 

1072
00:43:05,333 --> 00:43:07,369
ERA THAT MANY PEOPLE WERE 

1073
00:43:07,369 --> 00:43:08,970
CONCERNED AT ANY AMOUNT AND MUCH

1074
00:43:08,970 --> 00:43:10,639
HIGHER NUMBER OR PERCENTAGE, 

1075
00:43:10,639 --> 00:43:12,641
EXCUSE ME, WERE CONCERNED IF THE

1076
00:43:12,641 --> 00:43:14,276
AMOUNT OF PAYMENT WAS 

1077
00:43:14,276 --> 00:43:16,111
SUBSTANTIAL. THE MAJORITY IN 

1078
00:43:16,111 --> 00:43:19,815
THIS SAMPLE ALSO HAD SUBSTANTIAL

1079
00:43:19,815 --> 00:43:21,149
MISCONCEPTIONS ABOUT INDUCEMENT 

1080
00:43:21,149 --> 00:43:22,717
AND BASICALLY THOUGHT EITHER ONE

1081
00:43:22,717 --> 00:43:25,020
OF THEM WAS EXPLAINED BY 

1082
00:43:25,020 --> 00:43:27,255
SOMEBODY DECIDING TO DO 

1083
00:43:27,255 --> 00:43:28,790
SOMETHING THAT THEY OTHERWISE 

1084
00:43:28,790 --> 00:43:30,725
PROBABLY WOULDN'T DO. I THINK, I

1085
00:43:30,725 --> 00:43:32,661
HOPE I CONVINCE YOU THAT IS NOT 

1086
00:43:32,661 --> 00:43:34,396
THE DEFINITION OF EITHER CO. WER

1087
00:43:34,396 --> 00:43:37,899
SHUN OR UNDUE INDUCEMENT. 

1088
00:43:37,899 --> 00:43:41,169
INTERGLY THE SAME COHORT OF IRB 

1089
00:43:41,169 --> 00:43:42,771
MEMBERS ACROSS THE COUNTRY, WHEN

1090
00:43:42,771 --> 00:43:46,408
WE ASKED THEM, IS IT OKAY TO 

1091
00:43:46,408 --> 00:43:49,845
REIMBURSE PARTICIPANTS FOR 

1092
00:43:49,845 --> 00:43:51,513
EXPENSES ALMOST ALL SAID YES. 

1093
00:43:51,513 --> 00:43:53,081
REGARDLESS WHETHER THEY WERE 

1094
00:43:53,081 --> 00:43:54,850
HEALTHY OR PATIENTS IN STUDIES 

1095
00:43:54,850 --> 00:43:56,451
WITH NO PROSPECT OF BENEFIT OR 

1096
00:43:56,451 --> 00:43:58,053
PROSPECT OF BENEFIT. ALMOST ALL 

1097
00:43:58,053 --> 00:44:00,055
THOUGHT IT WAS FINE TO 

1098
00:44:00,055 --> 00:44:01,923
COMPENSATE PEOPLE FOR TIME AND 

1099
00:44:01,923 --> 00:44:03,058
INCONVENIENCE. FEWER THOUGHT 

1100
00:44:03,058 --> 00:44:05,093
OKAY TO OFFER MONEY AS 

1101
00:44:05,093 --> 00:44:07,529
INCENTIVE. FEWER STILL OFFER 

1102
00:44:07,529 --> 00:44:12,300
MONEY AS A COME P COMPENSATION 

1103
00:44:12,300 --> 00:44:15,403
FOR RISK. THERE ARE THESE 

1104
00:44:15,403 --> 00:44:16,505
INTERESTING -- I FOUND THIS 

1105
00:44:16,505 --> 00:44:18,206
WEBSITE THAT HAS A TOOL YOU CAN 

1106
00:44:18,206 --> 00:44:23,411
PLUG IN DETAILS OF YOUR STUDY. 

1107
00:44:23,411 --> 00:44:25,814
THEY WILL CALCULATE FOR YOU HOW 

1108
00:44:25,814 --> 00:44:27,816
MUCH YOU SHOULD PAY PEOPLE. IT 

1109
00:44:27,816 --> 00:44:29,518
IS ENTERING. WHAT THEY SAY HERE 

1110
00:44:29,518 --> 00:44:31,853
IS DECIDING ON THE RIGHT 

1111
00:44:31,853 --> 00:44:33,355
INCENTIVE AMOUNT IS A DELICATE 

1112
00:44:33,355 --> 00:44:35,090
PROBLEM. PAY TOO LITTLE, YOU 

1113
00:44:35,090 --> 00:44:36,992
WON'T GET ENOUGH PARTICIPANTS. 

1114
00:44:36,992 --> 00:44:39,427
PAY TOO MUCH, YOU BLOW UP YOUR 

1115
00:44:39,427 --> 00:44:42,564
BUDGET. THEY DID RESEARCH AND 

1116
00:44:42,564 --> 00:44:46,134
ARE USING THAT FOR THE ALGORITHM

1117
00:44:46,134 --> 00:44:47,469
THEY PROVIDE FOR FIGURING HOW 

1118
00:44:47,469 --> 00:44:48,970
MUCH YOU SHOULD PAY. I DON'T 

1119
00:44:48,970 --> 00:44:51,172
KNOW HOW GOOD IT IS. THOUGHT I 

1120
00:44:51,172 --> 00:44:54,676
WOULD PUT IT OUT AS SOMETHING TO

1121
00:44:54,676 --> 00:44:59,514
LOOK AT. IT WAS UPDATED PRETTY 

1122
00:44:59,514 --> 00:45:03,118
RECENTLY. SO HOW DO WE DECIDE 

1123
00:45:03,118 --> 00:45:06,821
HOW MUCH TO OFFER RESEARCH 

1124
00:45:06,821 --> 00:45:07,856
PARTICIPANTS? YOU MIGHT THINK 

1125
00:45:07,856 --> 00:45:10,392
THERE ARE BENCHMARKS. WE DID A 

1126
00:45:10,392 --> 00:45:12,460
STUD DAY FEW YEARS AGO WHERE WE 

1127
00:45:12,460 --> 00:45:14,829
LOOKED AT THE INCONVENIENCED 

1128
00:45:14,829 --> 00:45:18,600
UNITS USED BY RESEARCHERS IN THE

1129
00:45:18,600 --> 00:45:20,635
CLINICAL CENTER QUITE A WHOLING 

1130
00:45:20,635 --> 00:45:24,406
A OVER THE PERIOD OF 2004-2008 

1131
00:45:24,406 --> 00:45:27,342
TO SEE HOW CON VER GENETIC THEY 

1132
00:45:27,342 --> 00:45:29,578
WERE IN TERMS OF THE AMOUNT THEY

1133
00:45:29,578 --> 00:45:32,314
PAID BUT ALSO THE NUMBER OF 

1134
00:45:32,314 --> 00:45:34,115
INCONVENIENCE UNITS THEY 

1135
00:45:34,115 --> 00:45:35,717
ASSIGNED. LET ME POINT OUT A 

1136
00:45:35,717 --> 00:45:37,719
COUPLE THINGS. HERE IF YOU LOOK 

1137
00:45:37,719 --> 00:45:39,654
HERE AT LUMBAR PUNCTURE THE 

1138
00:45:39,654 --> 00:45:43,224
RANGE WAS FROM ONE INCONVENIENCE

1139
00:45:43,224 --> 00:45:45,393
UNIT TO 57 INCONVENIENCE UNITS. 

1140
00:45:45,393 --> 00:45:48,930
THAT IS HUGE. MRIs WERE NOT MUCH

1141
00:45:48,930 --> 00:45:50,832
BETTER, 0-40. UP HERE, THINGS 

1142
00:45:50,832 --> 00:45:52,567
LIKE BLOOD DRAW, THERE WAS LOTS 

1143
00:45:52,567 --> 00:45:56,471
OF CONVERGENCE. MOST PEOPLE 

1144
00:45:56,471 --> 00:45:58,807
THOUGHT HAVING A BLOOD DRAW WAS 

1145
00:45:58,807 --> 00:46:01,343
TOO MANY UNITS. MANY OF YOU 

1146
00:46:01,343 --> 00:46:03,578
MIGHT KNOW WE HAD A SYSTEM WHERE

1147
00:46:03,578 --> 00:46:05,580
THERE WAS A NUMBER PREDICTING --

1148
00:46:05,580 --> 00:46:06,982
SORRY, RECOMMENDED FOR THE 

1149
00:46:06,982 --> 00:46:08,984
AMOUNT OF TIME A PERSON SPENT BY

1150
00:46:08,984 --> 00:46:11,553
HOUR OR BY DAY AND BY THE NUMBER

1151
00:46:11,553 --> 00:46:14,823
OF INCONVENIENCE UNITS. 

1152
00:46:14,823 --> 00:46:17,125
INCONVENIENCE UNIT IN THESE DATA

1153
00:46:17,125 --> 00:46:22,263
IS $10. SO $20 FOR BLOOD 

1154
00:46:22,263 --> 00:46:25,200
DRAWING. THOSE KINDS OF 

1155
00:46:25,200 --> 00:46:26,868
BENCHMARKS DON'T EXIST VERY 

1156
00:46:26,868 --> 00:46:28,470
WIDELY. THEY ARE VERY HARD TO 

1157
00:46:28,470 --> 00:46:32,240
FIND. THERE IS A COLLEAGUE IN 

1158
00:46:32,240 --> 00:46:35,810
NIDCD WHO SAID I COULD TELL YOU 

1159
00:46:35,810 --> 00:46:39,347
HER NAME, DEANA LYON COLLECTING 

1160
00:46:39,347 --> 00:46:42,617
DATA ON INTRA MURAL COMPENSATION

1161
00:46:42,617 --> 00:46:45,086
SO SHE MAY HAVE MORE RECENT 

1162
00:46:45,086 --> 00:46:46,354
BENCHMARKS THAN OTHERS I JUST 

1163
00:46:46,354 --> 00:46:50,091
SHOWED YOU FROM THE OTHER SLIDE.

1164
00:46:50,091 --> 00:46:51,626
OTHER WAYS TO SORT OF THINK 

1165
00:46:51,626 --> 00:46:52,861
ABOUT HOW TO PAY SOMEBODY ARE 

1166
00:46:52,861 --> 00:46:54,696
REASONS WE ARE PAYING THEM? 

1167
00:46:54,696 --> 00:46:56,831
PAYING THEM TO INCENTIVISE THEM 

1168
00:46:56,831 --> 00:46:59,100
OR REIMBURSING THEM OR 

1169
00:46:59,100 --> 00:47:01,903
COMPENSATING THEM FOR THEIR TIME

1170
00:47:01,903 --> 00:47:08,543
AND INCON  CONVENIENCE /* 

1171
00:47:08,543 --> 00:47:10,178
INCONVENIENCE? THE DESIGN 

1172
00:47:10,178 --> 00:47:11,980
MATTERS. THOSE THINGS MATTER. 

1173
00:47:11,980 --> 00:47:14,549
THIS IS SIMILAR TO THEIR 

1174
00:47:14,549 --> 00:47:15,617
CONTRIBUTIONS, MAYBE 

1175
00:47:15,617 --> 00:47:17,118
VULNERABILITIES. BUDGET. IN THE 

1176
00:47:17,118 --> 00:47:20,822
STUDY I JUST SHOWED YOU WHERE WE

1177
00:47:20,822 --> 00:47:24,993
LOOKED AT INTERMURAL PAYMENT, 

1178
00:47:24,993 --> 00:47:27,495
MOST OF THE TIME INVESTIGATORS 

1179
00:47:27,495 --> 00:47:32,434
GAVE A NUMBER. THEY DIDN'T USE 

1180
00:47:32,434 --> 00:47:34,436
THE TIME AND CONVENIENCE UNITS, 

1181
00:47:34,436 --> 00:47:37,072
JUST GAVE A NUMBER. I'M GOING TO

1182
00:47:37,072 --> 00:47:45,046
PAY PEOPLE X NUMBER OF DOLLARS. 

1183
00:47:45,046 --> 00:47:46,648
IF YOU LOOK THOSE ARE DICTATED 

1184
00:47:46,648 --> 00:47:47,949
ABOUT HOW MUCH MONEY THE 

1185
00:47:47,949 --> 00:47:49,417
RESEARCHER HAS. BUDGETS ARE CON 

1186
00:47:49,417 --> 00:47:51,252
TRAINED. IF YOU THINK ABOUT A 

1187
00:47:51,252 --> 00:47:52,287
THOUSAND PARTICIPANTS YOU ARE 

1188
00:47:52,287 --> 00:47:54,556
GOING TO HAVE TO PAY LESS THAN 

1189
00:47:54,556 --> 00:47:56,491
IF YOU ARE -- AND YOU HAVE THE 

1190
00:47:56,491 --> 00:47:59,728
SAME BUDGET THAN IF YOU HAVE 

1191
00:47:59,728 --> 00:48:06,835
MUCH LOWER NUMBER. IT IS 

1192
00:48:06,835 --> 00:48:08,837
IMPORTANT AS YOU SAW THE 

1193
00:48:08,837 --> 00:48:09,871
GUIDELINES THAT PAYMENT BE FAIR 

1194
00:48:09,871 --> 00:48:11,573
AND JUST. THOSE ARE THINGS WE 

1195
00:48:11,573 --> 00:48:14,008
NEED TO THINK THROUGH IN TERMS 

1196
00:48:14,008 --> 00:48:15,844
OF IF WE ARE PAYING PEOPLE FOR 

1197
00:48:15,844 --> 00:48:19,647
THEIR TIME AND INCONVENIENCE, 

1198
00:48:19,647 --> 00:48:22,717
EVERYBODY WHO'S GIVING US TIME 

1199
00:48:22,717 --> 00:48:25,019
AND INCONVENIENCE SHOULD BE PAID

1200
00:48:25,019 --> 00:48:27,155
FAIRLY AND JUSTLY. IF WE ARE 

1201
00:48:27,155 --> 00:48:29,357
PAYING $50 FOR AN MRI, EVERYBODY

1202
00:48:29,357 --> 00:48:31,893
WHO IS GETTING THE MRI SHOULD BE

1203
00:48:31,893 --> 00:48:34,929
GETTING THE $50. WE NEED TO 

1204
00:48:34,929 --> 00:48:36,364
CONSIDER INSTITUTIONAL 

1205
00:48:36,364 --> 00:48:39,400
GUIDELINES, LOCAL, SOCIETAL, 

1206
00:48:39,400 --> 00:48:43,171
LEGAL, CULTURAL NORMALS THERE 

1207
00:48:43,171 --> 00:48:52,347
ARE SOME PLACES WHERE PAYMENT IS

1208
00:48:52,347 --> 00:48:56,251
LOOKED UPON SUSPICIOUS, TRUE IF 

1209
00:48:56,251 --> 00:49:00,155
YOU HAVE INTERNATIONAL SITES OR 

1210
00:49:00,155 --> 00:49:02,357
DOING RESEARCH BE EARLY. WHEN 

1211
00:49:02,357 --> 00:49:04,225
AND HOW THERE ARE MECHANISMS FOR

1212
00:49:04,225 --> 00:49:06,060
PAYING PEOPLE NOT SIMPLY CASH. 

1213
00:49:06,060 --> 00:49:07,929
IN FACT, CASH IS HARDEST. THERE 

1214
00:49:07,929 --> 00:49:09,898
ARE GIFT CARDS AND VOUCHERS AND 

1215
00:49:09,898 --> 00:49:12,433
OTHER THINGS. SOME PEOPLE LIKE 

1216
00:49:12,433 --> 00:49:15,970
THOSE LESS THAN THEY LIKE CASH. 

1217
00:49:15,970 --> 00:49:18,940
SOME PLACES PAY IN-KIND WITH, 

1218
00:49:18,940 --> 00:49:21,242
YOU KNOW, FOOD OR DIAPERS OR 

1219
00:49:21,242 --> 00:49:29,150
OTHER THINGS THAT PEOPLE MIGHT 

1220
00:49:29,150 --> 00:49:31,452
NEED THEN A LOT OF DISCUSSION 

1221
00:49:31,452 --> 00:49:34,055
ABOUT WHEN. I THINK SOME THINK 

1222
00:49:34,055 --> 00:49:35,890
PRO RATING IS A FAIR WAY TO PAY 

1223
00:49:35,890 --> 00:49:37,759
FOR THINGS THEY HAVE CONTRIBUTED

1224
00:49:37,759 --> 00:49:40,962
THUS FAR. COMPLETION BONUSES AT 

1225
00:49:40,962 --> 00:49:48,603
SOME LEVEL ARE ETHICALLY 

1226
00:49:48,603 --> 00:49:50,872
ACCEPTABLE. LOOP CHALLENGEES AND

1227
00:49:50,872 --> 00:49:53,107
COLLEAGUES PUT A FRAMEWORK FOR 

1228
00:49:53,107 --> 00:49:55,610
PAYING PARTICIPANTS IN THE NEW 

1229
00:49:55,610 --> 00:49:56,978
ENGLAND JOURNAL A COUPLE YEARS 

1230
00:49:56,978 --> 00:50:00,148
AGO, THERE ARE A COUPLE OF 

1231
00:50:00,148 --> 00:50:00,882
POINTS ON THE BOX FOR 

1232
00:50:00,882 --> 00:50:03,151
CONSIDERATION FOR INVESTIGATORS.

1233
00:50:03,151 --> 00:50:04,586
THEY HAVE IN PAPER CONSIDERATION

1234
00:50:04,586 --> 00:50:07,455
FOR IRB MEMBERS SO IF YOU ARE 

1235
00:50:07,455 --> 00:50:09,257
INTERESTED IN LOOKING AT THOSE. 

1236
00:50:09,257 --> 00:50:10,792
FIRST AND FOREMOST THEY SAY IT 

1237
00:50:10,792 --> 00:50:12,794
IS IMPORTANT TO COMMUNE KAPT THE

1238
00:50:12,794 --> 00:50:14,462
RATIONALE FOR WHY YOU DECIDED ON

1239
00:50:14,462 --> 00:50:15,697
A SPECIFIC AMOUNT. THAT IS FOR 

1240
00:50:15,697 --> 00:50:18,266
THE IRB. TO UNDERSTAND WHETHER 

1241
00:50:18,266 --> 00:50:20,435
IT IS REIMBURSEMENT, 

1242
00:50:20,435 --> 00:50:22,437
COMPENSATION, INCENTIVE OR ALL 

1243
00:50:22,437 --> 00:50:26,007
THE ABOVE. THEY ALSO TALK ABOUT 

1244
00:50:26,007 --> 00:50:28,476
FAIRLY REIMBURSING AND 

1245
00:50:28,476 --> 00:50:31,079
COMPENSATING PEOPLE. GO ON TO 

1246
00:50:31,079 --> 00:50:32,780
SAY WE SHOULD BE REIMBURSING 

1247
00:50:32,780 --> 00:50:34,249
PEOPLE UNLESS THERE IS A STRONG 

1248
00:50:34,249 --> 00:50:37,752
REASON NOT TO. WE SHOULD ALSO BE

1249
00:50:37,752 --> 00:50:39,053
COMPENSATING PARTICIPANTS FOR 

1250
00:50:39,053 --> 00:50:42,257
THEIR TIME, COMMITMENT AND 

1251
00:50:42,257 --> 00:50:43,791
BURDENS THEY ASSUME. THEN 

1252
00:50:43,791 --> 00:50:45,660
PROVIDE JUSTIFICATION FOR WHY 

1253
00:50:45,660 --> 00:50:50,765
THE RATES PROPOSED FOR 

1254
00:50:50,765 --> 00:50:53,868
COMPENSATING PEOPLE ARE FAIR. 

1255
00:50:53,868 --> 00:50:55,603
INCENTIVES ONLY WHEN PROPOSING 

1256
00:50:55,603 --> 00:50:57,705
TO OFFER MORE THAN WOULD BE 

1257
00:50:57,705 --> 00:50:59,807
JUSTIFIED BY REIMBURSEMENT OR 

1258
00:50:59,807 --> 00:51:01,209
COMPENSATION. THEN TALK ABOUT 

1259
00:51:01,209 --> 00:51:03,912
OTHER THINGS I THINK REALLY 

1260
00:51:03,912 --> 00:51:05,546
IMPORTANT, WE DON'T HAVE 

1261
00:51:05,546 --> 00:51:07,215
INSURANCE COVERAGE FOR PEOPLE 

1262
00:51:07,215 --> 00:51:08,783
WHO MIGHT SUFFER 

1263
00:51:08,783 --> 00:51:10,718
RESEARCH-RELATED INJURIES AS A 

1264
00:51:10,718 --> 00:51:12,654
SEPARATE ISSUE BUT ONE THEY 

1265
00:51:12,654 --> 00:51:15,590
INCLUDED IN THIS PAPER. AND THEY

1266
00:51:15,590 --> 00:51:19,827
TALK ABOUT INCREASING SAFEGUARDS

1267
00:51:19,827 --> 00:51:21,262
FOR UNDERSTANDING, COMPREHENSION

1268
00:51:21,262 --> 00:51:23,298
AND INFORMED CONSENT. THEY 

1269
00:51:23,298 --> 00:51:26,234
DIDN'T TALK ABOUT SAFEGUARDS FOR

1270
00:51:26,234 --> 00:51:27,335
MISREPRESENTATION BUT I THINK 

1271
00:51:27,335 --> 00:51:31,239
THEY MIGHT IF THEY WERE ASKED 

1272
00:51:31,239 --> 00:51:34,776
TODAY. SO, IN SUM, REIMBURSING 

1273
00:51:34,776 --> 00:51:37,145
EXPENSES SHOULD BE STANDARD. 

1274
00:51:37,145 --> 00:51:38,980
COMPENSATION FOR TIME AND 

1275
00:51:38,980 --> 00:51:40,515
INCONVENIENCE IS FAIR AND 

1276
00:51:40,515 --> 00:51:42,817
RESPECTFUL AND SHOULD BE DONEN 

1277
00:51:42,817 --> 00:51:44,919
MOST CASES. INCENTIVES MAY BE 

1278
00:51:44,919 --> 00:51:46,654
USEFUL IN SOME CASES. THAT IS ON

1279
00:51:46,654 --> 00:51:49,590
TOP OF THE OTHER TWO. PAYMENT IS

1280
00:51:49,590 --> 00:51:51,292
ACCEPTABLE BY REGULATION AND BY 

1281
00:51:51,292 --> 00:51:53,828
ETHICAL ANALYSIS. OFFERING MONEY

1282
00:51:53,828 --> 00:51:57,265
IS NOT COERCIVE. IS UNLIKE TLOI 

1283
00:51:57,265 --> 00:52:00,234
RESULT IN UNJUST INDUCEMENT. MAY

1284
00:52:00,234 --> 00:52:01,469
PROMOTE UNDERSTANDING NOT 

1285
00:52:01,469 --> 00:52:03,871
INTERFERE WITH IT. LIKELY 

1286
00:52:03,871 --> 00:52:06,341
REDUCES THE CHANCE OF 

1287
00:52:06,341 --> 00:52:07,508
EXPLOITATION. WE NEED TO TAKE 

1288
00:52:07,508 --> 00:52:12,180
STEPS TO REDUCE THE CHANCES IN 

1289
00:52:12,180 --> 00:52:15,416
RARE CASE IT MIGHT OCCUR AND 

1290
00:52:15,416 --> 00:52:16,951
MISREPRESENTATION OR DECEPTION 

1291
00:52:16,951 --> 00:52:18,720
THAT COMES WITH PAYING PEOPLE 

1292
00:52:18,720 --> 00:52:22,223
AND OTHER MOTIVATIONS 

1293
00:52:22,223 --> 00:52:22,890
PARTICIPATING IN RESEARCH. THANK

1294
00:52:22,890 --> 00:52:26,594
YOU, I THINK THERE IS SOME TIME 

1295
00:52:26,594 --> 00:52:27,095
FOR QUESTIONS. 

1296
00:52:27,095 --> 00:52:27,762
    

1297
00:52:27,762 --> 00:52:29,097
   >> OKAY THAT, IS GREAT.
THAT 

1298
00:52:29,097 --> 00:52:31,733
WAS A FANTASTIC PRESENTATION. WE

1299
00:52:31,733 --> 00:52:35,169
DO HAVE SOME QUESTIONS AND/OR 

1300
00:52:35,169 --> 00:52:36,237
COMMENTS. IF YOU STILL HAVE 

1301
00:52:36,237 --> 00:52:38,573
QUESTIONS YOU'D LIKE TO SUBMIT, 

1302
00:52:38,573 --> 00:52:40,208
PLEASE GO AHEAD AND DO SO. CLICK

1303
00:52:40,208 --> 00:52:43,811
ON THE BOX THAT SAYS LIVE 

1304
00:52:43,811 --> 00:52:46,114
FEEDBACK LINK. LET ME GO AHEAD 

1305
00:52:46,114 --> 00:52:48,049
AND GET TO QUESTIONS WE HAVE. 

1306
00:52:48,049 --> 00:52:51,853
    OKAY. HERE'S ONE. SHOULD WE 

1307
00:52:51,853 --> 00:52:53,187
CONSIDER THE PROVISION OF FREE 

1308
00:52:53,187 --> 00:52:54,622
MEDICAL CARE ASSOCIATED WITH THE

1309
00:52:54,622 --> 00:52:56,958
TRIAL AT THE NIH CLINICAL CENTER

1310
00:52:56,958 --> 00:53:02,063
AS FORM OF COMPENSATION TO OUR 

1311
00:53:02,063 --> 00:53:02,430
PARTICIPANTS? 

1312
00:53:02,430 --> 00:53:04,365
   >> SO HERE IS WHERE WE
KNOW 

1313
00:53:04,365 --> 00:53:07,235
LANGUAGE PROBABLY MATTERS. I 

1314
00:53:07,235 --> 00:53:08,536
DON'T KNOW IF IT IS 

1315
00:53:08,536 --> 00:53:11,406
COMPENSATION. I THINK IT IS AN 

1316
00:53:11,406 --> 00:53:12,940
INCENTIVE. I THINK PEOPLE DO 

1317
00:53:12,940 --> 00:53:15,910
SOMETIMES COME TO THE CLINICAL 

1318
00:53:15,910 --> 00:53:17,912
CENTER BECAUSE THEY GET FREE 

1319
00:53:17,912 --> 00:53:20,748
MEDICAL CARE. IT IS CERTAINLY A 

1320
00:53:20,748 --> 00:53:22,583
BENEFIT FOR THEM. WHETHER IT IS 

1321
00:53:22,583 --> 00:53:24,185
COMPENSATION IN TRUE SENSE OF 

1322
00:53:24,185 --> 00:53:25,353
WHAT COMPENSATION IS ABOUT, I'M 

1323
00:53:25,353 --> 00:53:27,588
NOT SO SURE ABOUT THAT. I MEAN, 

1324
00:53:27,588 --> 00:53:30,525
IT IS DEFINITELY A BENEFIT AND 

1325
00:53:30,525 --> 00:53:32,326
DEFINITELY AN INCENTIVE. I DON'T

1326
00:53:32,326 --> 00:53:34,062
KNOW IF THAT ANSWERS THE 

1327
00:53:34,062 --> 00:53:34,595
QUESTIONER'S QUESTION. 

1328
00:53:34,595 --> 00:53:36,297
   >> OKAY. THERE WAS A
COUPLE 

1329
00:53:36,297 --> 00:53:43,104
QUESTIONS REGARDING MY MINORS. 

1330
00:53:43,104 --> 00:53:46,841
ARE THERE SPECIFICS WHEN PARENT 

1331
00:53:46,841 --> 00:53:48,910
IS ENROLLING IN RESEARCH AND A 

1332
00:53:48,910 --> 00:53:50,711
SIMILAR QUESTION, CAN YOU A 

1333
00:53:50,711 --> 00:53:52,547
DRESS PAYMENT TO MINORS FOR 

1334
00:53:52,547 --> 00:53:53,548
RESEARCH PARTICIPATION THERE 

1335
00:53:53,548 --> 00:53:54,615
HAVE BEEN SITUATIONS WHERE THE 

1336
00:53:54,615 --> 00:53:56,350
PARENT MAY PRESSURE THE CHILD TO

1337
00:53:56,350 --> 00:53:57,952
PARTICIPATE FOR THE FINANCIAL 

1338
00:53:57,952 --> 00:53:59,887
BENEFITS AND CONCERNS ABOUT THE 

1339
00:53:59,887 --> 00:54:02,824
CHILD'S ABILITY TO CONSENT OR 

1340
00:54:02,824 --> 00:54:03,658
PROVIDE ASCENT. 

1341
00:54:03,658 --> 00:54:06,961
   >> YAH. SO THAT IS A
TRICKY 

1342
00:54:06,961 --> 00:54:08,796
AREA. ONE THAT WE HAVE WORKED ON

1343
00:54:08,796 --> 00:54:11,299
A LITTLE BIT IN THE PAST. I 

1344
00:54:11,299 --> 00:54:13,701
THINK WE DON'T HAVE A LOT OF 

1345
00:54:13,701 --> 00:54:15,770
DATA ON THIS. HERE IS THE WAY I 

1346
00:54:15,770 --> 00:54:18,139
THINK ABOUT IT. I THINK, YOU 

1347
00:54:18,139 --> 00:54:22,376
KNOWF WE ARE GIVING PEOPLE MONEY

1348
00:54:22,376 --> 00:54:25,880
FOR THEIR CONTRIBUTION, THEN 

1349
00:54:25,880 --> 00:54:30,585
CHILDREN SHOULD BE COME PPENSAT 

1350
00:54:30,585 --> 00:54:32,587
FOR THEIR CONTRIBUTION TOO. FOR 

1351
00:54:32,587 --> 00:54:33,821
SMALL CHILDREN MONEY DOESN'T 

1352
00:54:33,821 --> 00:54:35,590
MEAN THAT MUCH. WE SHOULD BE 

1353
00:54:35,590 --> 00:54:36,858
CREATIVE IN THINKING ABOUT WHAT 

1354
00:54:36,858 --> 00:54:39,927
WOULD BE A BETTER COMPENSATION 

1355
00:54:39,927 --> 00:54:43,865
FOR THE BURDEN AND INCONVENIENCE

1356
00:54:43,865 --> 00:54:46,300
THAT THE CHILD IS UNDERTAKING OR

1357
00:54:46,300 --> 00:54:47,468
ASSUMING TO BE PART OF RESEARCH.

1358
00:54:47,468 --> 00:54:51,739
THAT COULD BE, YOU KNOW, TOYS OR

1359
00:54:51,739 --> 00:54:54,008
COULD BE A COLLEGE -- DONATION 

1360
00:54:54,008 --> 00:54:55,776
TO A COLLEGE FUND OR SOMETHING, 

1361
00:54:55,776 --> 00:54:57,512
I DON'T KNOW. COULD BE OTHER 

1362
00:54:57,512 --> 00:55:01,048
KINDS OF WAYS TO GIVE CHILDREN 

1363
00:55:01,048 --> 00:55:03,451
RECOGNITION OR COMPENSATION FOR 

1364
00:55:03,451 --> 00:55:04,919
THEIR CONTRIBUTION. I THINK THE 

1365
00:55:04,919 --> 00:55:07,922
THING ABOUT PARENTS IS REALLY 

1366
00:55:07,922 --> 00:55:09,790
HARD BECAUSE IT IS TRUE, I'M 

1367
00:55:09,790 --> 00:55:13,828
AWARE THAT IT IS TRUE SOME 

1368
00:55:13,828 --> 00:55:16,564
PARENTS WOULD OR DO PRESSURE 

1369
00:55:16,564 --> 00:55:17,765
THEIR CHILDREN TO PARTICIPATE IN

1370
00:55:17,765 --> 00:55:18,833
ORDER TO GET MONEY OFFERED FOR 

1371
00:55:18,833 --> 00:55:22,436
THAT STUDY. THAT IS PROBLEMATIC,

1372
00:55:22,436 --> 00:55:25,072
FOR ME. I THINK WE NEED TO BE 

1373
00:55:25,072 --> 00:55:33,681
REALLY DILIGENT ABOUT HOW WE GET

1374
00:55:33,681 --> 00:55:35,316
ASCENT FROM CHILDREN WHEN 

1375
00:55:35,316 --> 00:55:36,384
STUDIES WITH MONEY INVOLVED SO 

1376
00:55:36,384 --> 00:55:37,451
THEY ARE NOT DOING IT BECAUSE 

1377
00:55:37,451 --> 00:55:39,420
THEIR PARENTS ARE PRESSURING 

1378
00:55:39,420 --> 00:55:42,857
THEM IN A VERY SIGNIFICANT WAY. 

1379
00:55:42,857 --> 00:55:47,161
ON THE OTHER HAND, PARENTS WHO 

1380
00:55:47,161 --> 00:55:49,764
BRING THEIR CHILDREN IN TO THE 

1381
00:55:49,764 --> 00:55:52,867
CLINICAL CENTER OR ANY CLINIC 

1382
00:55:52,867 --> 00:55:55,236
FOR RESEARCH PARTICIPATION INCUR

1383
00:55:55,236 --> 00:55:58,005
COSTS, RIGHT. THEY HAVE TO TAKE 

1384
00:55:58,005 --> 00:56:00,908
TIME OFF FROM WORK, PRESUMEGLY 

1385
00:56:00,908 --> 00:56:02,643
BLI, OR OTHER THINGS THEY ARE 

1386
00:56:02,643 --> 00:56:04,812
DOING. THEY HAVE TRANSPORTATION 

1387
00:56:04,812 --> 00:56:06,981
COSTS, FOOD COSTS, LODGING 

1388
00:56:06,981 --> 00:56:09,350
COSTS. WE SHOULD AT LEAST BE 

1389
00:56:09,350 --> 00:56:13,254
REIMBURSING THEIR COSTS SO THAT 

1390
00:56:13,254 --> 00:56:18,426
THEY DON'T HAVE FINANCIAL COSTS 

1391
00:56:18,426 --> 00:56:20,928
FROM HELPING THEIR CHILD BE A 

1392
00:56:20,928 --> 00:56:22,396
PARTICIPANT IN RESEARCH. I DON'T

1393
00:56:22,396 --> 00:56:24,098
KNOW IF YOU GOT THE TWO SIDES OF

1394
00:56:24,098 --> 00:56:26,567
MY WORRY. I THINK WE SHOULD BE 

1395
00:56:26,567 --> 00:56:28,936
REIMBURSING PEOPLE. I THINK 

1396
00:56:28,936 --> 00:56:30,304
PARENTS, EXCUSE ME. I THINK WE 

1397
00:56:30,304 --> 00:56:32,773
SHOULD BE THINKING OF CREATIVE 

1398
00:56:32,773 --> 00:56:34,508
WAYS TO COMPENSATE CHILDREN. 

1399
00:56:34,508 --> 00:56:36,510
DON'T THINK WE WANT TO PROVIDE 

1400
00:56:36,510 --> 00:56:37,645
INCENTIVES FOR PARENTS TO 

1401
00:56:37,645 --> 00:56:38,646
PRESSURE THEIR CHILDREN. 

1402
00:56:38,646 --> 00:56:40,748
   >> OKAY. I HAVE A 

1403
00:56:40,748 --> 00:56:42,083
CLARIFICATION ON THE EARLIER 

1404
00:56:42,083 --> 00:56:43,551
QUESTION ABOUT PROVISION OF FREE

1405
00:56:43,551 --> 00:56:45,419
MEDICAL CARE THAT YOU GET AT THE

1406
00:56:45,419 --> 00:56:47,655
CLINICAL CENTER. IS THIS AN 

1407
00:56:47,655 --> 00:56:49,890
INCENTIVE THAT COULD POTENTIALLY

1408
00:56:49,890 --> 00:56:56,664
BE UNDUE INDUCEMENT? 

1409
00:56:56,664 --> 00:57:00,501
   >> I THINK IN MOST
CASES THE 

1410
00:57:00,501 --> 00:57:05,406
ANSWER IS NO. I THINK PEOPLE -- 

1411
00:57:05,406 --> 00:57:07,308
I HAVE BEEN HERE A LONG TIME. I 

1412
00:57:07,308 --> 00:57:10,044
HAVE SEEN A LOT OF STUDIES OVER 

1413
00:57:10,044 --> 00:57:12,847
THE YEARS. MY STRONG IMPRESSION 

1414
00:57:12,847 --> 00:57:16,817
FROM BOTH ASKING PEOPLE BUT ALSO

1415
00:57:16,817 --> 00:57:23,924
OBSERVING IS THAT PEOPLE COME 

1416
00:57:23,924 --> 00:57:25,926
HERE THINK FEEL ARE IMPORTANT 

1417
00:57:25,926 --> 00:57:26,861
FOR THEIR DISEASE. MOST THE 

1418
00:57:26,861 --> 00:57:28,963
PEOPLE WE HAVE AT THE CLINICAL 

1419
00:57:28,963 --> 00:57:30,364
CENTER ARE NOT HEALTHY 

1420
00:57:30,364 --> 00:57:31,899
VOLUNTEERS; THEY ARE PATIENTS. 

1421
00:57:31,899 --> 00:57:33,968
THEY HAVE CONDITIONS THAT ARE 

1422
00:57:33,968 --> 00:57:36,170
RARE, THAT ARE HARD TO TREAT, 

1423
00:57:36,170 --> 00:57:37,772
THAT, YOU KNOW, HAVE EXPERTS 

1424
00:57:37,772 --> 00:57:39,006
HERE THAT KNOW THINGS ABOUT 

1425
00:57:39,006 --> 00:57:42,543
THEIR DISEASE THAT OTHER PEOPLE 

1426
00:57:42,543 --> 00:57:44,011
DON'T KNOW. THEY DO GET 

1427
00:57:44,011 --> 00:57:45,579
TREATMENT HERE THEY MIGHT NOT BE

1428
00:57:45,579 --> 00:57:49,450
ABLE TO GET ON THE OUTSIDE. THE 

1429
00:57:49,450 --> 00:57:54,255
FACT IT IS FREE IS A REALLY 

1430
00:57:54,255 --> 00:57:55,256
WONDERFUL BENEFIT BUT I DON'T 

1431
00:57:55,256 --> 00:58:00,695
THINK IT IS AN UNDUE INDUCEMENT 

1432
00:58:00,695 --> 00:58:04,231
THAT THEY WILL COME HERE AND NOT

1433
00:58:04,231 --> 00:58:05,933
CARE ABOUT DETAILS AND RISKS 

1434
00:58:05,933 --> 00:58:07,702
BECAUSE IT IS FREE. THEY ARE NOT

1435
00:58:07,702 --> 00:58:11,339
GOING TO COME FOR REASONS. IT IS

1436
00:58:11,339 --> 00:58:14,442
A DIFFERENT STORY WITH 

1437
00:58:14,442 --> 00:58:15,910
VOLUNTEERS. WE ARE TO BE 

1438
00:58:15,910 --> 00:58:17,478
COGNIZANT. WE HAVE SEEN OVER THE

1439
00:58:17,478 --> 00:58:20,247
YEARS, AND THIS GOES BACK TO 

1440
00:58:20,247 --> 00:58:25,586
MISREPRESENTATION WORRY, WE HAVE

1441
00:58:25,586 --> 00:58:27,355
SEEN, NOT COMMON BUT HAPPEN, 

1442
00:58:27,355 --> 00:58:28,389
HEALTHY VOLUNTEERS WHO VOLUNTEER

1443
00:58:28,389 --> 00:58:31,225
THREE, FOUR STUDIES AT THE SAME 

1444
00:58:31,225 --> 00:58:33,294
TIME, SOMETIMES STUDIES THAT 

1445
00:58:33,294 --> 00:58:35,529
CONTRADICT EACH OTHER. I 

1446
00:58:35,529 --> 00:58:43,170
REMEMBER ONE CASE YEARS A WHEN 

1447
00:58:43,170 --> 00:58:44,839
DISCOVERED AN INDIVIDUAL 

1448
00:58:44,839 --> 00:58:47,208
VOLUNTEER FOR THREE WEIGHT LOSS 

1449
00:58:47,208 --> 00:58:54,148
STUDIES BUT SIMULTANEOUSLY. THAT

1450
00:58:54,148 --> 00:58:57,918
SCREWS UP THE DATA. IF YOU ARE 

1451
00:58:57,918 --> 00:58:59,487
TRYING INTERVENTION FOR WEIGHT 

1452
00:58:59,487 --> 00:59:00,955
LOSS AND DOING THREE AT THE SAME

1453
00:59:00,955 --> 00:59:02,757
TIME YOU ARE NOT GOING TO KNOW 

1454
00:59:02,757 --> 00:59:06,627
IF ANY WORK. WE NEED TO BE 

1455
00:59:06,627 --> 00:59:13,667
VIGILANT ABOUT WHAT KINDS OF 

1456
00:59:13,667 --> 00:59:15,669
STUDIES PEOPLE ARE PARTICIPATING

1457
00:59:15,669 --> 00:59:22,543
IN. OFTEN BECAUSE THEY WANT THE 

1458
00:59:22,543 --> 00:59:26,180
COMPENSATION. MANY YEARS AGO 

1459
00:59:26,180 --> 00:59:28,048
THERE WAS INTERNAL REGISTRY SO 

1460
00:59:28,048 --> 00:59:32,486
YOU COULD FIND OUT WHAT KIND OF 

1461
00:59:32,486 --> 00:59:36,390
STUDIES THEY WERE IN AND AVOID 

1462
00:59:36,390 --> 00:59:38,959
THAT PROBLEM WITH MULTIPLE 

1463
00:59:38,959 --> 00:59:42,029
STUDIES MAY BE ATTRACTIVE 

1464
00:59:42,029 --> 00:59:44,799
BECAUSE THEY WERE OFFERING 

1465
00:59:44,799 --> 00:59:45,833
PAYMENT. WE DON'T HAVE A 

1466
00:59:45,833 --> 00:59:47,635
REGISTRY, TO MY KNOWLEDGE. ONE 

1467
00:59:47,635 --> 00:59:49,036
OTHER THING OF INTEREST IN THIS 

1468
00:59:49,036 --> 00:59:50,671
REGARD IS ONE OF THE STUDIES 

1469
00:59:50,671 --> 00:59:53,174
WHICH I DIDN'T PUT UP THAT JILL 

1470
00:59:53,174 --> 00:59:58,846
FISCHER DID, SHE WAS LOOKING AT 

1471
00:59:58,846 --> 00:59:59,780
HEALTHY VOLUNTEERS IN DRUG 

1472
00:59:59,780 --> 01:00:01,215
DEVELOPMENT STUDIES AND TRYING 

1473
01:00:01,215 --> 01:00:03,284
TO GET A SENSE OF -- SOMETIMES 

1474
01:00:03,284 --> 01:00:05,019
PEOPLE SAY THAT IS HOW THEY -- 

1475
01:00:05,019 --> 01:00:06,987
THAT IS THEIR INCOME, HOW THEY 

1476
01:00:06,987 --> 01:00:10,691
MAKE MONEY AND LIVE ON IT. THE 

1477
01:00:10,691 --> 01:00:12,760
AVERAGE AMOUNT OF MONEY -- I'M 

1478
01:00:12,760 --> 01:00:14,562
GOING TO FORGET NOW. THE AVERAGE

1479
01:00:14,562 --> 01:00:16,597
AMOUNT PEOPLE MADE IN A YEAR OF 

1480
01:00:16,597 --> 01:00:20,100
THE COHORT SHE STUDIED WAS LIKE 

1481
01:00:20,100 --> 01:00:24,472
LESS THAN $10,000. SO CERTAINLY 

1482
01:00:24,472 --> 01:00:27,241
AN ADJUNCT TO PEOPLE'S INCOME 

1483
01:00:27,241 --> 01:00:29,944
BUT NOT TOO MANY CAN LIVE ON 

1484
01:00:29,944 --> 01:00:30,878
LESS THAN $10,000 TODAY. 

1485
01:00:30,878 --> 01:00:32,880
   >> OKAY. WE ARE ABOUT
OUT OF 

1486
01:00:32,880 --> 01:00:35,015
TIME BUT I HAVE ONE OR TWO MORE 

1487
01:00:35,015 --> 01:00:36,917
THINGS. WOULD YOU COMMENT ON 

1488
01:00:36,917 --> 01:00:38,819
COMPETITION BY PHARMA HAVING 

1489
01:00:38,819 --> 01:00:41,722
MUCH HIGHER REMUNERATION? 

1490
01:00:41,722 --> 01:00:43,123
   >> YAH. I MEAN THIS WAS
ONE 

1491
01:00:43,123 --> 01:00:46,060
OF THE REASONS THAT, YOU KNOW, 

1492
01:00:46,060 --> 01:00:48,929
20 YEARS AGO WE PROPOSED MAYBE 

1493
01:00:48,929 --> 01:00:51,832
THINKING THE WAGE PAYMENT MODEL 

1494
01:00:51,832 --> 01:00:55,302
IS THE BEST FOR THINKING ABOUT 

1495
01:00:55,302 --> 01:00:59,840
HOW TO COME UP WITH AMOUNTS FOR 

1496
01:00:59,840 --> 01:01:01,041
COMPENSATION BECAUSE INDUSTRIES 

1497
01:01:01,041 --> 01:01:03,744
DO HAVE BIGGER BUDGETS THAN 

1498
01:01:03,744 --> 01:01:07,214
ACADEMICS GENERALLY. THEY CAN 

1499
01:01:07,214 --> 01:01:09,984
THEREFORE PAY MORE FOR RESEARCH 

1500
01:01:09,984 --> 01:01:13,454
PARTICIPANTS. THAT CREATES A 

1501
01:01:13,454 --> 01:01:16,357
MARKET THAT IS UNFAIR TO 

1502
01:01:16,357 --> 01:01:26,867
RESEARCHERS WHO HAVE SMALLER 

1503
01:01:27,268 --> 01:01:29,970
BUDGETS. A LOT OF TIME THE 

1504
01:01:29,970 --> 01:01:32,773
STUDIES ARE DIFFERENT. I 

1505
01:01:32,773 --> 01:01:33,674
MENTIONED THE PHASE I, THEY PAY 

1506
01:01:33,674 --> 01:01:34,842
PRETTY WELL FOR THOSE BUT THOSE 

1507
01:01:34,842 --> 01:01:36,310
ARE PEOPLE WHO HAVE NO OTHER 

1508
01:01:36,310 --> 01:01:39,547
REASON TO PARTICIPATE AND GO 

1509
01:01:39,547 --> 01:01:41,549
INTO THESE CLINICAL RESEARCH 

1510
01:01:41,549 --> 01:01:43,350
UNITS AND OFTEN REQUIRED TO STAY

1511
01:01:43,350 --> 01:01:44,718
THERE THREE, FOUR WEEKS 

1512
01:01:44,718 --> 01:01:46,153
SOMETIMES. THEY HAVE A WHOLE 

1513
01:01:46,153 --> 01:01:47,655
BUNCH OF THINGS DONE TO THEM. 

1514
01:01:47,655 --> 01:01:49,723
THEY ARE ON RESTRICTED DIETS, 

1515
01:01:49,723 --> 01:01:53,294
CAN'T SMOKE, LOTS OF THINGS 

1516
01:01:53,294 --> 01:01:59,266
HAPPEN TO THEM. IN THOSE KINDS 

1517
01:01:59,266 --> 01:01:59,934
YOU THINK THEY SHOULD PAY 

1518
01:01:59,934 --> 01:02:01,402
BECAUSE THAT IS A LOT TO THE 

1519
01:02:01,402 --> 01:02:03,637
ASK. I THINK THE PROBLEMATIC 

1520
01:02:03,637 --> 01:02:05,239
ONES ARE THIS IS A STUDY OF A 

1521
01:02:05,239 --> 01:02:08,275
DRUG A LOT OF PEOPLE WOULD 

1522
01:02:08,275 --> 01:02:11,745
BENEFIT FROM. A DRUG COMPANY 

1523
01:02:11,745 --> 01:02:22,323
MIGHT WANT TO EXPEDITE AND PAY 

1524
01:02:22,323 --> 01:02:24,425
MORE IN CRO THAN INSTITUTIONN. 

1525
01:02:24,425 --> 01:02:25,626
THOSE CASES I THINK IT IS HARD 

1526
01:02:25,626 --> 01:02:27,061
FOR ACADEMICS TO COMPETE. 

1527
01:02:27,061 --> 01:02:28,762
   >> OKAY. I THINK WE
WILL STOP

1528
01:02:28,762 --> 01:02:30,464
THERE IN INTEREST OF TIME. THERE

1529
01:02:30,464 --> 01:02:32,933
WERE A COUPLE I MAY SEND TO YOU 

1530
01:02:32,933 --> 01:02:34,435
OFF-LINE, IF THAT IS OKAY. 

1531
01:02:34,435 --> 01:02:35,202
   >> OKAY. 

1532
01:02:35,202 --> 01:02:37,237
   >> WE ARE VERY
APPRECIATIVE 

1533
01:02:37,237 --> 01:02:38,906
OF YOUR TIME AND FANTASTIC 

1534
01:02:38,906 --> 01:02:40,774
PRESENTATION. JUST AN 

1535
01:02:40,774 --> 01:02:42,109
ANNOUNCEMENT, OUR NEXT EDUCATION

1536
01:02:42,109 --> 01:02:46,313
SESSION WILL BE THURSDAY 

1537
01:02:46,313 --> 01:02:47,748
FEBRUARY 1ST AT 3:00 VIA NIH 

1538
01:02:47,748 --> 01:02:50,184
VIDEO CAST TITLED OVERVIEW OF 

1539
01:02:50,184 --> 01:02:52,519
IRB EXPECTATIONS WHEN 

1540
01:02:52,519 --> 01:02:54,221
NON-ENGLISH SPEAKING PERSONS 

1541
01:02:54,221 --> 01:02:55,322
ENROLL IN RESEARCH. IMPORTANCE 

1542
01:02:55,322 --> 01:02:57,024
OF ENSURING COMPREHENSION. WE 

1543
01:02:57,024 --> 01:02:58,359
HOPE YOU WILL ALL BE ABLE TO 

1544
01:02:58,359 --> 01:03:00,060
JOIN US FOR THAT AS WELL, SO
THANK YOU, EVERYBODY. 

1545
01:03:00,060 --> 01:03:10,060
THANKS, PEG.