EVERYONE TO THE ETHICAL AND
REGULATORY ASPECTS OF CLINICAL
RESEARCH 2024 AND THIRD TIME
THAT DEPARTMENT OF BIOETHICS HAS
OFFERED THIS COURSE.
I'M HOLLY TAYLOR AND FACULTY IN
THE DEPARTMENT OF BIOETHICS AND
WILL BE YOUR COURSE DIRECTOR.
YOU WILL SEE ME MULTIPLE TIMES
AND WE ALSO HAVE OTHER FACULTY
FROM THE DEPARTMENT AND GUEST
FACULTY THAT WILL JOIN US EITHER
IN PERSON OR VIRTUALLY
THROUGHOUT THE TERM.
I AM GOING TO GIVE YOU ALL A
RELATIVELY QUICK INTRODUCTION TO
THE COURSE WITH A FOCUS ON SOME
LOGISTICS OF USING CANVAS, WHICH
IS THE WEB-BASED PROGRAM WE ARE
USING TO RUN THE COURSE.
IF YOU COULD PUT MY SLIDES UP ON
THE SCREEN.
SO THIS IS ME.
QUICK DISCLAIMER AND REMINDER WE
ARE SPEAKING ON BEHALF OF
OURSELVES AND NOT TAKING AN
OFFICIAL POSITION AS IT RELATES
TO NIEHS DHH OR US GOVERNMENT
AND I WON'T READ ALL OF THE
OBJECTIVES.
THESE ARE IN THE SYLLABUS YOU
CAN REFER TO.
THERE IS OBJECTIVES FOR THE
COURSE AS WELL AS FOR EACH
SESSION.
I HAVE JUST HIGHLIGHTED A COUPLE
OF THINGS HERE; RIGHT?
DR. GRADY WILL INTRODUCE A
FRAMEWORK THIS MORNING THAT WILL
BE A BASIS FOR THE COURSE AND
LOOKING MORE CLOSELY AT SOME OF
THE KEY PRINCIPLES IN THE
FRAMEW
FRAMEWORK.
WE WILL TALK ABOUT CODES AND
REGULATIONS AND I SHOULD SAY
THAT WE ARE IN THE US AND AT NIH
AND MOST OF WHAT WE WILL TALK
ABOUT IS US CENTRIC.
I AM HOPING THAT MUCH OF THIS IS
RELEVANT TO THOSE NOT IN THE US
AND FEEL FREE TO ASK QUESTIONS
ABOUT THINGS AND I CAN MAYBE
REFER YOU TO RESOURCES IF IT IS
NOT SOMETHING I KNOW BECAUSE I'M
GENERALLY DOMESTICALLY FOCUSED.
WE WILL TALK ABOUT IRBS AND
INFORMED CONSENT AND RISKS AND
BENEFITS AND FAIR SUBJECT
SELECTION AND WILL HAVE A DAY ON
GENETICS RESEARCH AND WILL HAVE
A PANEL THIS YEAR OF INDIVIDUALS
WHO HAVE PARTICIPATED IN
CLINICAL RESEARCH HERE AT
CLINICAL CENTER THAT I'M REALLY
EXCITED ABOUT AND WILL END THE
TERM WITH A PANEL OR THREE
DIFFERENT LECTURES ON
INTERNATIONAL COLLABORATIVE
RESEARCH.
HERE IS THE OVERVIEW.
THIS IS ALSO IN THE SYLLABUS
JUST TO GIVE YOU A SNAPSHOT.
THESE ARE TOPICS WE WILL COVER.
AS YOU KNOW, WE MEET EVERY
WEDNESDAY MORNING AT 8:30.
THIS IS A WAY FOR YOU TO CHECK
IN ON WHAT WILL HAPPEN EACH DAY.
ON THE SYLLABUS, YOU WILL FIND
ADDITIONAL INFORMATION AND
REMINDER THAT WE LIVESTREAM
BETWEEN 8:30 AND 11:30 A.M. US
EASTERN.
THIS IS NOT RELEVANT TO THOSE
THAT ARE NOT LISTENING.
IF YOU HAVE TO MISS A SESSION
FOR EXAMPLE OR HAVE A SCHEDULING
CONFLICT THROUGHOUT THE TERM,
THE COURSE -- MY RECORDING OF
THIS AND ALL OF THE LECTURES
TODAY WILL BE POSTED ON THE
CANVAS SITE AND ON THE PAST
EVENTS FOR THE NIH VIDEO CAST
WHERE YOU ARE ALL LINKED IN NOW
ABOUT 48 HOURS LATER.
SO SOON AS THOSE ARE AVAILABLE,
I WILL POST THEM.
YOU CAN REVIEW THEM THEN.
AND IT MIGHT BE A SHORTER TIME
OR A LITTLE LONGER TIME.
THAT IS GENERALLY WHEN OUR GREAT
AV CREW IS ABLE TO GET THE
MATERIAL TO ME.
ALL OF YOU -- NOT EVERYONE BUT
MOST THAT ARE LISTENING HAVE
ENROLLED IN THE COURSE.
THAT MEANS YOU HAVE ACCESS TO
CANVAS.
FOR ANYONE JUST LISTENING TO
THE LIVESTREAM AND YOU WANT TO
HAVE ACCESS TO COURSE MATERIALS,
WHAT YOU WILL NEED TO DO IS
ENROLL IN CANVAS.
AND THAT INFORMATION IS
AVAILABLE.
I WILL -- LET'S SEE.
WE WILL MAKE SURE THAT
INFORMATION -- IT IS AVAILABLE
ON THE DEPARTMENT OF BIOETHICS
WEBSITE.
IF YOU GOOGLE NIH DEPARTMENT OF
BIOETHICS AND GO TO COURSES, YOU
WILL FIND INFORMATION YOU NEED
TO SELF-ENROLL.
IF YOU WANT A CERTIFICATE OF
COMPLETION, YOU NEED TO ALSO
SELF-REGISTER.
THERE IS A SURVEY QUIZ ON CANVAS
YOU NEED TO COMPLETE.
MANY OF YOU HAVE DONE THAT
ALREADY.
THANK YOU VERY MUCH.
IN ORDER TO GET A CERTIFICATE --
A GENERAL CERTIFICATE, YOU NEED
TO COMPLETE THREE SESSION
QUIZZES THAT ARE ALL IN CANVAS
AT THE END OF EACH MODULE.
I THINK I HAVE AN EXAMPLE OF
THAT IN A SECOND.
FOR THOSE GETTING THE GENERAL
CERTIFICATE, YOU NEED TO
COMPLETE THREE OF THE QUIZZES.
IF YOU ARE COMPLETING THE COURSE
TOWARDS THE NIH CORE CURRICULUM
ON CLINICAL RESEARCH, YOU NEED
TO COMPLETE AT LEAST SIX OF
THOSE AND YOU MIGHT AS WELL DO
ALL 7.
SO IN ADDITION TO THE QUIZ AND
THAT IS, AGAIN, IN CANVAS, ALEX,
WHO IS MY ASSISTANT THIS TERM IS
GOING TO SECOND YOU A SESSION
EVALUATION THAT IS TO GIVE US
FEEDBACK ABOUT WHETHER WE ARE
SHARING, MEETING THE GOALS AND
OBJECTIVES AND GETTING
INFORMATION TO YOU IN A CLEAR
WAY.
SO YOU WILL RECEIVE THAT BY
E-MAIL.
PLEASE SEND, YOU KNOW, RETURN
THAT.
SO THESE WILL COME TO YOU BY
E-MAIL AND QUIZZES FOR THE
SESSIONS WILL NOT.
WILL YOU HAVE TO GO IN AND
COMPLETE THOSE.
NOW, LAST WEEK, I SENT OUT THE
PRECOURSE ASSESSMENT.
THANK YOU TO THE 300 + OF YOU
WHO COMPLETED THAT ASSIGNMENT.
IT IS NOW CLOSED.
I WANTED TO GET YOUR KNOWLEDGE
BEFORE THE COURSE BEGINS.
IF YOU DIDN'T HAVE A CHANCE TO
COMPLETE IT, NOT A PROBLEM. YOU
-- IT IS CLOSED.
YOU CAN'T.
WILL YOU HAVE ANOTHER CHANCE AT
THE END OF THE COURSE.
I WILL SEND OUT BY E-MAIL A POST
COURSE ASSESSMENT.
FEEL FREE TO SEND THAT BACK.
THAT IS -- THIS GOES TO EVERYONE
WHO IS SELF-ENROLLED.
SO NOT JUST THOSE THAT HAVE
REGISTERED.
I WOULD LOVE TO HEAR FROM ALL OF
YOU.
SO HOPEFULLY EVERYONE IS NOW
FAMILIAR WITH THIS WEBSITE.
THIS IS WHAT THE CANVAS HUB
LOOKS LIKE FROM YOUR
PERSPECTIVE.
IF YOU SELF-ENROLLED, IT SHOULD
HAVE TAKEN YOU RIGHT TO THIS
PLACE.
FOR SOME REASON IF YOU ARE
ENROLLED IN MULTIPLE CANVAS
COURSES, YOU MIGHT HAVE TO FIND
IT ON YOUR HOMEPAGE.
I WANTED TO HIGHLIGHT THE
SELF-REGISTRATION SURVEY.
IT IS AT THE TOP OF THE KEY
DOCUMENT SECTION.
YOU CAN CLICK RIGHT THERE OR
CLICK JUST TO THE RIGHT WHERE
THE BLUE HIGHLIGHTED VERSION OF
THE QUIZ IS.
AGAIN, THIS IS -- OOPS. SORRY
THIS IS INSIDE OF CANVAS.
PLEASE COMPLETE THAT IF YOU
WOULD LIKE TO GET A CERTIFICATE
OF COMPLETION.
THERE IS THE BUTTON TO PUSH WHEN
YOU GET THERE.
NOW, I JUST WANT TO SCROLL DOWN
A LITTLE AND SHARE A LITTLE MORE
ABOUT WHAT IS ON THIS PAGE.
IF YOU SCROLL DOWN FROM THE KEY
DOCUMENTS, YOU WILL GET TO
SESSION 1 WHICH IS WHERE WE ARE
TODAY.
THE FIRST LINK ON EVERY MODULE
IS THE LINK TO THE VIDEOCAST.
SO IF YOU FORGET OR YOU HAVE NOT
CLICKED IT IN YOUR WEB BROWSER
AS A PLACE TO RETURN TO, YOU CAN
ALWAYS GO TO THE FIRST LINK IN
THE SESSION.
IN ADDITION, THERE IS A SESSION
SUMMARY FOR EACH DAY.
YOU CAN OPEN THAT. AGAIN,
ORIENT YOURSELF WHAT WILL
HAPPEN. OBJECTIVES AND SCHEDULE
AND YOU WILL SEE THERE, THERE IS
A LISTING OF THE READINGS.
THE READINGS ARE FOR YOU.
YOU ARE WELCOME TO REVIEW THEM.
YOU CAN LOOK AT THEM AFTER THE
CLASS HAS ENDED AND SOME MAY BE
RESOURCES FOR YOU MOVING ON.
BUT ALL OF THE READINGS ARE
LINKED IN THE MODULE.
SO, FOR TODAY, FOR EXAMPLE, HERE
ARE THE READINGS.
YOU SHOULD BE ABLE TO CLICK ON
EACH ONE OF THOSE.
THEY SHOULD COME UP.
I CHECKED THEM ALL YESTERDAY.
THEY WERE WORKING.
THAT IS WHERE YOU GET ACCESS TO
YOUR READINGS.
AND THEN THE SESSION QUIZZES ARE
ALWAYS AT THE VERY BOTTOM OF THE
MODULE.
AFTER TODAY'S LECTURE, I WILL --
YOU WILL BE ABLE TO GO TO THAT
QUIZ AT 11:30 AND COMPLETE IT.
YOU DON'T HAVE TO DO IT UNTIL
11:30.
IT WILL OPEN AFTER THE COURSE
ENDS BUT IS ALWAYS AT THE END OF
THE MODULE.
ONE OR TWO MORE THINGS FOR
TODAY.
SO AS WE HAVE -- I GUESS THERE
IS ABOUT 20 OF US HERE IN THE
AMPHITHEATRE, WHICH IS TOTALLY
AWESOME AND WILL MENTION THAT
ANYBODY ELSE ON THE NIH CAMPUS
AND WANTS TO JOIN US IN PERSON,
BY ALL MEANS, COME.
IT MEANS, A, IT IS LOVELY TO
HAVE PEOPLE IN THE AUDIENCE.
B, YOU GUYS ALWAYS GET FIRST
DIBS ON QUESTIONS.
IF YOU HAVE QUESTIONS IN THE AM
FEE THEATRE, THERE ARE TWO MICS
AND AV FOLKS WOULD LIKE YOU TO
GO USE THOSE SO EVERYONE CAN
HEAR THE QUESTION.
IF YOU ARE VIEWING ON VIDEOCAST
AND WANT TO ASK A QUESTION, CAN
YOU DO ONE OF TWO THINGS.
IF YOU ARE SELF-ENROLLED IN
CANVAS, YOU CAN GO TO THE PAGE
THAT I HAVE -- THE PLACE THAT I
HAVE CREATED ON THE DISCUSSIONS
BOARD THAT IS CALLED SESSION 1
QUESTIONS.
AND YOU CAN GO THERE AND ASK
YOUR QUESTION.
IF WE DON'T GET TO YOUR QUESTION
DURING CLASS, I WILL ANSWER YOUR
QUESTIONS ON THAT DISCUSSION
BOARD.
IF YOU ARE NOT IN CANVAS BUT
WANT TO ASK A QUESTION, YOU CAN
SEND THOSE QUESTIONS TO THIS
E-MAIL. ALEX WILL GET THEM.
LE FORWARD THEM TO ME DURING
CLASS AND/OR WE WILL POST THEM
IN THE DISCUSSION SESSION.
I WILL ANSWER THEM THERE.
SO A COUPLE MORE THINGS ABOUT
THE SESSION QUIZZES.
IF YOU DON'T WANT A CERTIFICATE,
DON'T BOTHER WITH THE QUIZZES.
IF YOU WANT A CERTIFICATE OF
COMPLETION, YOU HAVE TO TAKE AT
LEAST THREE OF THE 7.
IF NIH EMPLOYEE PURSUING THE
CORE CURRICULUM, YOU HAVE TO DO
AT LEAST 6.
THE SCORE DOESN'T MATTER.
PLEASE DON'T E-MAIL ME TO SAY,
OH, GOSH. I GOT THEM ALL WRONG.
CAN I TAKE IT AGAIN?
THE ANSWER WILL BE NO.
THE SCORE DOESN'T MATTER.
AND, AGAIN, THE QUIZZES, AS I
SAID, ALL OF THE QUIZZES ARE
AVAILABLE AFTER CLASS.
YOU WILL SEE HERE THAT THREE OF
-- FOUR OF THEM ARE GREEN THAT
MEANS THEY ARE AVAILABLE.
WHEN YOU OPEN IT UP, YOU WILL
SEE SOME ARE GREEN AND SOME
AREN'T.
THE SESSION QUIZ IS OPEN AFTER
CLASS.
SO THESE WILL BE GREEN WHEN YOU
GO THERE TO COMPLETE SESSION 4
QUIZ, FOR EXAMPLE.
I NEED TO UPDATE THAT. IT WILL
BE AVAILABLE FOR YOU THEN.
IF YOU GO TO THAT PAGE, YOU
WON'T SEE THEM ALL JUST YET.
THAT IS IT FOR ME.
SO ON TO THE CONTENT OF THE
COURSE.
WE ARE GOING TO HAVE DR.
CHRISTINE GRADY GIVE US AN
INTRODUCTION TO THE FRAMEWORK
FOR ETHICAL CONDUCT OF RESEARCH,
WHICH I SAID WILL BE SORT OF THE
BACKBONE OF YOUR COURSE.
THERE SAY READING ABOUT THE
FRAMEWORK AS WELL THAT I WOULD
HIGHLY RECOMMEND THAT YOU READ.
IT WILL JUST GIVE YOU A GOOD
BASE FOR WHAT IS COMING IN THE
REST OF THE COURSE.
DR. GRADY -- AND IS CHIEF OF THE
DEPARTMENT OF BIOETHICS.
FOR ALL DEPARTMENT OF ETHICS
BIOETHICS FACULTY I INCLUDED A
LINK YOU CAN USE TO GET
ADDITIONAL INFORMATION.
DR. GRADY HAS A LOT OF
EXPERIENCE AND WILL NOTE SHE IS
A NATIONAL LEADER AND SCHOLAR
WHO SERVED FROM 2010 TO 2017 AS
A COMMISSIONER FOR PRESIDENT'S
COMMISSION ON STUDY OF B
BIOETHICAL ISSUES AND WIDE RANGE
OF INTERESTS IN CLINICAL R- HE
SEARCH AND NURSING ETHICS AND IS
WORKING RECENTLY ON MORAL
CHALLENGES NURSES FACE WHEN
DELIVERING CARE.
I WILL NOTE THAT SHE CURRENTLY
CO-CHAIRS THE NIH-WIDE NEURO
ETHICS WORKING GROUP OF THE NIH
BRAIN INITIATIVE THAT IS BRAIN
RESEARCH THROUGH ADVANCINO
VATTIVE NEUROTECHNOLOGIES THAT
IS NIH-WIDE EFFORT.
SHE CO-CHAIRS ONE OF THE NEURO
ETHICS WORKING GROUPS.
WITH THAT, I WILL HAND IT OFF TO
DR. GRADY.
>> THANK YOU, HOLLY.
GOOD MORNING, EVERYONE IN THE
ROOM AND EVERYWHERE ELSE YOU ARE
WATCHING FROM.
AS HOLLY MENTIONED, I WILL TALK
ABOUT A FRAMEWORK FOR ETHICAL
CONDUCT OF CLINICAL RESEARCH.
HOLLY ELUDED TO THIS IS A
FRAMEWORK THAT THE COURSE IS
SORT OF BUILT ON.
YOU -- THE THINGS I WILL TALK
ABOUT IN THE NEXT 40 MINUTES YOU
WILL HEAR OVER AND OVER AGAIN
THROUGHOUT THE REST OF THE
COURSE.
I WILL MAKE REFERENCES TO THOSE.
BEFORE I START, I WANT TO THANK
HOLLY FOR DOING A GREAT JOB
ORGANIZING THIS COURSE AND ALEX.
THANK YOU BOTH.
THERE IS MY DISCLAIMER. I HAVE
NO CONFLICTS OF INTEREST.
I THINK WHEN WE THINK ABOUT
ETHICS OF CLINICAL RESEARCH,
THERE ARE SEVERAL BIG PICTURE
QUESTIONS WE SHOULD ASK
OURSELVES.
ONE IS, FIRST, BEFORE I ASK ANY
OF THEM, I WANT TO MAKE SURE WE
UNDERSTAND WHAT WE ARE TALKING
ABOUT WHEN TALKING ABOUT
CLINICAL RESEARCH AND THERE IS
LOTS OF KINDS OF RESEARCH WE
MIGHT BE INTERESTED IN THE
ETHICS OF AND CLINICAL RESEARCH
BEING RESEARCH ABOUT THE HEALTH
OF HUMANS.
AND IT IS EITHER RESEARCH TO --
TO UNDERSTAND BETTER THE HEALTH
OF HUMANS OR ILLNESS IN HUMANS
OR TO INTERVENE IN PREVENTION IN
DIAGNOSING OR TREATING.
THAT IS DOMAIN OF RESEARCH WE
ARE TALKING ABOUT AND PRECLUDES
FOR EXAMPLE BASIC RESEARCH,
PRECLINICAL RESEARCH AND
RESEARCH WITH NON-HUMAN ANIMALS
AND ALL KINDS OF RESEARCH NOT
RELATED TO HUMAN HEALTH.
THREE IMPORTANT QUESTIONS.
WHAT IS THE VALUE AND WHY DO WE
DO RESEARCH AT ALL IS ONE
QUESTION TO ASK.
SECOND SUBSET OF THAT IS IF WE
DO RESEARCH AT ALL TO TRY TO
UNDERSTAND HUMANS, WHY DO WE
HAVE TO INCLUDE HUMANS IN IT AND
INVOLVE HUMANS AND EXPERIMENT ON
HUMANS?
IF ANSWER TO BOTH OF THOSE IS IT
IS IMPORTANT AND WE NEED TO
INVOLVE HUMANS, HOW SHOULD WE DO
IT IN THE MOST ETHICAL MANNER.
I WILL TRY TO COVER THESE
BRIEFLY AND WITH RESPECT TO THE
VALUE, THIS IS JUST ONE EXAMPLE.
THIS IS THE NIH WEBSITE THAT
TALKS ABOUT IMPACT OF NIH
RESEARCH.
NIH IS ONE FUNDER OF RESEARCH
AND HAPPENS TO BE PROBABLY THE
LARGEST PUBLIC FUNDER OF
RESEARCH IN THE WORLD AND IS ONE
FUNDER.
YOU CAN SEE ON THE LEFT-HAND
SIDE HERE THAT IT TALKS ABOUT
IMPROVING HEALTH,
REVOLUTIONIZING SCIENCE AND
SERVING SOCIETY AND VALUE OF
RESEARCH IS TO UNDERSTAND AND
IMPROVE HEALTH FOR SURE AND WHAT
WE WILL TALK ABOUT MOSTLY.
THERE IS A COUPLE OTHER THINGS.
WE LEARN TO DO SCIENCE BETTER
AND LEARN NEW TECHNIQUES THAT
WILL IN THE FUTURE HELP IMPROVE
HEALTH.
THERE IS A WAY IN WHICH RESEARCH
ACTUALLY HAS A HUGE IMPACT ON
OTHER ASPECTS OF SOCIETY.
FOR EXAMPLE, IF YOU GO TO THE
WEBSITE ON SERVING SOCIETY, IT
WILL TALK ABOUT ECONOMIC VALUE
OF DOING RESEARCH THAT IS A BOOM
TO THE ECONOMY AND RAISES -- IT
PLACES WHERE RESEARCH IS FUNDED,
ECONOMY IS IMPROVED AND BY
HELPING PEOPLE BE HEALTHIER, WE
IMPROVE THE ECONOMY BECAUSE
PEOPLE CAN WORK.
THERE IS LOTS OF WAYS IN WHICH
RESEARCH ITSELF IS VALUABLE.
THIS IS JUST, YOU KNOW, NIH.
EVERYWHERE ELSE THAT FUNDS
RESEARCH OR DOES RESEARCH HAS
THE SAME KIND OF GOALS.
SO WHAT ABOUT INCLUDING HUMANS?
SO, ONE THING THAT IS PROBABLY
TRUE IS THAT THE KINDS OF
RESULTS THAT WE GET FROM DOING
CLINICAL RESEARCH HAVE
COMPELLING SOCIETAL HEALTH
BENEFITS.
THEY ARE NEW THERAPIES,
DIAGNOSTIC AND PREVENTIVE
STRATEGIES. IMPROVEMENT AND
QUALITY OF LIFE, ET CETERA.
ALL OF US CAN PROBABLY RECOGNIZE
EXAMPLES OF PEOPLE WHO HAVE
SURVIVED FROM A DEVASTATING
DISEASE OR NOT GOT A DEVASTATING
DISEASE BECAUSE OF RESEARCH
DISCOVERIES.
FOR EXAMPLE, TREATMENTS FOR HIV
HAVE CHANGED TRAJECTORY OF HIV
FROM A RAPIDLY FATAL DISEASE TO
PRETTY PEOPLE LIVING A NORMAL
LIFE WITH CHRONIC CONTROLLED
DISEASE AND TREATMENTS FOR
CHILDHOOD LEUKEMIA HAVE CHANGED
FROM RAPID DECLINE IN DEATH TO
90 PLUS PERCENT SURVIVAL AND
LIPID LOWERING DRUGS, CONSTANTLY
-- MANY, MANY PEOPLE ARE ON
LIPID LOWERING DRUGS THAT HAS
IMPROVED MORBIDITY AND MORTALITY
FROM CARDIOVASCULAR DISEASE AND
VACCINES FOR MEASLES OR POLIO OR
HPV OR COVID AND SO MANY OTHERS.
YOU CAN SORT OF THINK ABOUT THE
KINDS OF THINGS THAT HAVE BEEN
SHOWN TO WORK THROUGH CLINICAL
RESEARCH THAT HAVE MADE A MAJOR
IMPACT ON THE HEALTH OF SOCIETY
AND OF PEOPLE AND SAVING LIVES
AND IMPROVING THE QUALITY OF
HEALTH.
ALSO, AND THIS IS SORT OF THE
SAME IDEA.
IT IS SORT OF A MORE MICRO
LEVEL.
WHEN YOU GO TO A PHYSICIAN'S
OFFICE TO GET TREATED FOR
SOMETHING, YOU HOPE THAT THE
PHYSICIAN HAS SOME EVIDENCE UPON
WHICH TO MAKE A SUGGESTION ABOUT
WHAT YOU HAVE AND WHAT TO DO
ABOUT IT.
THOSE KINDS -- THAT EVIDENCE,
AGAIN, COMES FROM CLINICAL
RESEARCH AND MOST OF THE KINDS
OF THINGS WE DO WHEN WE GO TO A
DOCTOR'S OFFICE IS BASED ON
RESEARCH THAT HAD BEEN DONE IN
THE PAST.
THERE IS ALSO A PRETTY CLEAR
UNDERSTANDING THAT HUMAN
PARTICIPATION IS NECESSARY IN
ORDER TO GAIN ACCURATE AND
RELEVANT DATA FOR HUMANS.
WE DO -- THE NORMAL TRAJECTORY
OF RESEARCH IS BASIC IN VIVO --
I MEAN IN VITRO, SORRY THAN
PRECLINICAL IN NON-HUMAN ANIMALS
AND MOST NON-HUMAN ANIMALS ARE
NOT PERFECT FOR HUMANS AND
TESTING THINGS FOR HUMANS AND
UNDERSTANDING THINGS FOR HUMANS
IN RESEARCH IS IMPORTANT TO
UNDERSTAND HOW HUMANS WORK AND
WHAT WORKS IN HUMANS AND REASON
WHY WE DO IT.
WHY IS IT CHALLENGING THEN?
RESEARCH IS GOOD AND HUMANS
NECESSARY AND WHAT IS THE
PROBLEM; RIGHT?
PROBLEM IS PRIMARY GOAL OF DOING
RESEARCH IS TO GENERATE
KNOWLEDGE AND GENERATE USEFUL
KNOWLEDGE ABOUT HUMAN HEALTH AND
ILLNESS AND NO THE TO BENEFIT
PEOPLE THAT ARE PART OF THE
STUDY AND DOESN'T MEAN THAT
PEOPLE IN STUDIES DON'T BENEFIT.
THEY OFTEN DO.
THAT IS NOT THE GOAL.
THEY OFTEN DON'T BENEFIT.
WE ARE REALLY ASKING A SMALL
NUMBER OF PEOPLE TO ACCEPT RISK
AND BURDEN IN ORDER TO ANSWER
IMPORTANT QUESTIONS THAT MIGHT
BE BENEFICIAL TO OTHERS.
THEREFORE THE PEOPLE WHO ARE
BEING ENROLLED IN RESEARCH AND
WHO ARE PARTICIPATING IN
RESEARCH ARE MEANS TO DEVELOPING
USEFUL KNOWLEDGE AND THEREFORE
AT RISK OF BEING EXPLOITED.
THERE IS LOTS OF PUBLIC SORT OF
FEELING ABOUT THIS ISSUE AND IF
YOU TALK TO PEOPLE WHO DON'T
KNOW MUCH ABOUT RESEARCH YOU
CAN'T DO MUCH RESEARCH ON HUMANS
AND MAKING HUMANS INTO GUINEA
PIGS AND MUCH RESEARCH ON GOALS
OF RESEARCH AND HOW RESEARCH IS
DONE AND IS LOTS OF FEELINGS
ABOUT NOT USING PEOPLE AS HUMAN
GUINEA PIGS AND ETHICS OF
CLINICAL RESEARCH IF WHAT I SAID
MADE SENSE SO FAR HAS TWO REALLY
IMPORTANT PARTS OR GOALS TO IT.
ONE, WE WANT TO PROMOTE
RESPONSIBLE AND YOUTHFUL
RESEARCH THAT WILL BENEFIT
SOCIETY AND FUTURE PATIENTS THAT
IS ETHICAL DOING GOOD CLINICAL
R- HE SEARCH AND SAME TIME WANT
TO MINIMIZE ANY HARM AND
POSSIBILITY OF EXPLOITATION BY
PROTECTING RIGHTS AND WELFARE OF
THE PARTICIPANTS AND PROTECTING
AND RESPECTING.
BOTH OF THOSE ARE IMPORTANT.
SOMETIMES THEY COME INTO
TENSION, BY THE WAY.
ETHICAL REQUIREMENTS WE WILL
LEARN ABOUT OR YOU WILL LEARN
ABOUT IN THIS COURSE AND SOME
MIGHT KNOW ABOUT ALREADY HOW TO
PROVIDE GUIDANCE TO ALLOW THIS
TO HA P AND EDGE KALILY CONDUCT
RESEARCH TO PROMOTE RESPONSIBLE
RESEARCH SEEKING PROGRESS
MINIMIZING EXPLOITATION AND HARM
OR POSSIBILITY OF ENSURING
RIGHTS OF WELFARE AND
PARTICIPANTS ARE RESPECTED
HELPING TO MAINTAIN TRUST OF THE
PUBLIC IN THE RESEARCH
ENTERPRISE THAT ARE ALL
IMPORTANT PIECES OF IT.
HOW DO WE -- HOW DO WE CONDUCT
RESEARCH EDGE KALILY?
HOW DO WE DO THAT AND PROMOTE
RESEARCH PROTECTING RIGHTS AND
WELFARE MAINTAINING PUBLIC
TRUST.
WE LEARNED OVER THE COURSE OF
HISTORY THROUGH MANY HISTORICAL
LESSONS THINGS THAT ARE
IMPORTANT IN TERMS HOW TO
CONDUCT RESEARCH AND WE CAN GO
THROUGH ETHICAL REASONS.
I WILL DO A LITTLE OF EACH AND
WON'T SPEND MUCH TIME ON
HISTORY.
LATER SUSAN LEDDERER WILL SPEAK
TO YOU. SHE IS A HISTORIAN THAT
HAS DONE A HUGE AMOUNT OF WORK
ON HISTORY OF ETHICS AND
RESEARCH AND WILL LET HER GIVE
SPECIFIC EXAMPLES.
SHE IS A WONDERFUL RESOUCHER AS
WELL. YEARS AGO [INDISCERNIBLE]
WHICH TRIED TO DIVIDE THE ETHICS
OF CLINICAL RESEARCH
HISTORICALLY INTO DIFFERENT
ERAS.
BRIEFLY, TO GIVE YOU A SENSE OF
HOW THIS WENT, YOU KNOW, FOR A
LONG TIME, HUNDREDS OF YEARS,
THERE WERE NO RULES OR
GUIDELINES AND THERE WERE NO
LIMITS ON WHAT PEOPLE COULD DO.
IN FACT, THERE WASN'T MUCH MONEY
OR THERE WEREN'T MANY RESOURCES
FOR CLINICAL RESEARCH EITHER.
RESEARCH WAS OFTEN DONE BY
INDIVIDUAL SCIENTISTS OR
CLINICIANS WHO HAD SOME EXTRA
TIME OR MONEY.
BUT MOSTLY WITH THE MOTIVE OF
TRYING TO BENEFIT INDIVIDUALS
THAT THEY WERE RESPONSIBLE FOR.
AND BECAUSE THERE WERE SO FEW
GUIDELINES, THERE WAS LOTS OF --
YOU KNOW, SOMETIMES THE
EXPERIMENTS WERE WORSE THAN NO
EXPERIMENT.
THERE WAS A LOT OF NEGATIVE
OUTCOMES RATHER THAN ONLY
POSITIVE.
THAT -- WHEN THERE WAS MORE
MONEY AND RESOURCES AND
ATTENTION TO RESEARCH, EXCUSE
ME, AND VALUE OF RESEARCH, WE
WENT INTO WHAT PEOPLE HAVE IN
RETROSPECT CALLED A VERIUTE
ILLTARIAN ERA.
PEOPLE THAT WERE MARGINALIZED
AND CAPTIVE AND UNIMPORTANT TO
SOCIETY WERE ASKED TO
PARTICIPATE IN RESEARCH THAT WAS
SEEN AS GOOD FOR COMMON GOOD AND
GOOD FOR THE MAJORITY.
YOU WILL HEAR ABOUT SOME OF THE
EXAMPLES FROM SUSAN LATER IN
PROBABLY YOU KNOW SOME OF THEM
ANYWAY IN HISTORY AND LED TO AN
ERA OF SCRUTINY AND SOME
EXPOSURE OF THOSE KINDS OF
EXPERIMENTS DONE WITH PRISONERS
AND ORPHANS AND OTHER VERY
VULNERABLE PEOPLE AND PEOPLE --
THE SCIENTIFIC AND LAY COMMUNITY
STARTED TO SAY WHAT ARE WE
DOING?
WHAT IS HAPPENING WITH RESEARCH
AND WAS INTENSE SCRUTINY DRIVEN
BY A COUPLE OF VERY PUBLIC
CASES.
THAT LED TO QUESTIONS ABOUT WHAT
THE LIMITS AND SCOPE OF CLINICAL
RESEARCH OUGHT TO BE.
FROM THAT SCRUTINY, THERE WERE
DERIVED A NUMBER OF RULES AND
REGULATIONS THAT EMPHASIZED AND
FOCUSED ON PROTECTION OF THE
PARTICIPANTS AND PROTECTION OF
HUMAN PARTICIPANTS IN RESEARCH.
YOU WILL SEE AND MAYBE YOU KNOW
LOTS OF RULES AND REGULATIONS
HAVE THAT AS THEIR PRIMARY
FOCUS.
I WOULD SAY IN THE LAST NOW
ALMOST 30 YEARS, I GUESS, THERE
HAS BEEN A LITTLE BIT OF A
PENDULUM SWING IN THE SENSE THAT
CLINICAL RESEARCH IS RECOGNIZED
AS A BENEFIT. THAT A BENEFIT
SOMETIMES TO PEOPLE WHO WANT TO
BE IN CLINICAL TRIALS BECAUSE IT
IS A WAY FOR THEM TO ACCESS
EXPERIMENTAL DRUGS THEY COULDN'T
GET ELSEWHERE, EXCUSE ME.
ALSO, TO BENEFIT FOR POPULATIONS
AND HAS BEEN FOR EXAMPLE
RECOGNITION THAT CHILDREN HAVE
BEEN WHAT SOME PEOPLE CALL
THERAPEUTIC ORPHANS AND HAS BEEN
INSUFFICIENT AMOUNT OF RESEARCH
TO GENERATE EVIDENCE ON HOW TO
TREAT CHILDREN APPROPRIATELY.
THEREFORE INCLUDING THEM IN
RESEARCH IS A BENEFIT.
THEN WE LEARN HOW TO TREAT
CHILDREN.
THAT HAS BEEN A VERY INSIGHT
THAT HAPPENED OVER THE LAST 30
OR SO YEARS.
DURING THIS TIME, AND CURRENTLY,
THERE ARE -- THERE WERE DERIVED
A NUMBER OF CODES AND GUIDELINES
AND REGULATIONS THAT GUIDE
CLINICAL RESEARCH.
SOME OF THESE YOU PROBABLY HAVE
HEARD ABOUT.
EXCUSE ME.
I WILL MENTION A FEW OF THEM
JUST BRIEFLY. NUR EMBERG CODE
WAS CODE WRITTEN AT END OF WWII
TRIAL OF NAZI DOCTORS DOING
NUMBER OF EXPERIMENTS ON NAZI
PERFECTIZENERS OF WWII.
DECLARATION OF HELSINKI FOLLOWED
15 YEARS LATER ALMOST BY WORLD
MEDICAL ASSOCIATION AND BEGAN TO
REALIZE THAT ALTHOUGH THE
TENANTS OF THE NUR EMBERG CODE
WERE IMPORTANT THEY DIDN'T APPLY
SO OBVIOUSLY TO RESEARCH DONE BY
DOCTORS WITH PATIENTS TO TRY TO
IMPROVE PATIENTS.
THAT DECLARATION HAS BEEN
REVISED MULTIPLE TIMES AND MOST
RECENT PUBLISHED VERSION IS
2013.
THEY ARE IN THE PROCESS OF
REVISING IT AT THIS MOMENT AND
HAS BEEN A NUMBER OF MEETINGS
AROUND THE WORLD TO
CONSULTANCIES TO TRY TO GET THAT
REVISED AGAIN.
WE WILL SEE A NEW DECLARATION OF
HELSINKI, I'M ASSUMING, THIS
YEAR.
BELMONT REPORT WAS A REPORT FROM
THE NATIONAL -- THE UNITED
STATES NATIONAL COMMISSION FOR
THE PROTECTION OF PARTICIPANTS
OF BIOMEDICAL AND BEHAVIORAL
RESEARCH THAT WAS A COMMISSION
PUT INTO PLACE AFTER THE
EXPOSURE OF THE TUSKEGEE PUBLIC
HEALTH SERVE CIVILUS STUDIES.
BELMONT REPORT IS NOT A SET OF
RULES BUT EXPLICATION FOR
UNDERLYING RULES OF ETHICS AND
DOCUMENT THAT IS SHORT AND EASY
TO READ AND BASIS ON WHICH OUR
REGULATIONS HAVE BEEN MADE.
CIOMS PROVIDES INTERNATIONAL
GUIDELINES AND THOSE GUIDELINES
ORIGINALLY TOOK THE GOAL THAT
THEY TOOK WAS TO TAKE THE
PRINCIPLES ENUNCIATED IN
DECLARATION OF HELSINKI APPLYING
THEM SPECIFICALLY TO KINDS OF
RESEARCH SPONSORED BY RESEARCH
RICH COUNTRY KUN DUCTED IN
RESOURCE POORER COUNTRY.
EXCUSE ME.
THEY ARE ONE THING THAT I REALLY
LIKE ABOUT CIOMS GUIDELINES IS
NOT ONLY DO THEY HAVE TENANTS
THAT ALL THESE OTHERS DO TOO BUT
THEY EXPLAIN THEM AND HAVE MANY
PARAGRAPHS OF EXPLANATION AND
WHY THEY THINK THIS IS IMPORTANT
HOW YOU WOULD ACTUALLY IMPLEMENT
IT AND IS A USEFUL DOCUMENT TO
LOOK AT FOR MORE THAN JUST
INTERNATIONAL RESEARCH.
ICHGCP IS INTERNATIONAL
CONFERENCE ON HARMONIZATION AND
GOOD CLINICAL PRACTICE
GUIDELINES INTERNATIONAL
CONFERENCE ON HARMONIZATION WAS
A GROUP THAT GOT TOGETHER IN THE
1990YS TO SAY WE ARE DOING
CLINICAL RESEARCH AROUND THE
WORLD AND WHEN DOING RESEARCH IN
THE UNITED STATES AND WANT TO
ADOPT FINDINGS IN THE EUROPEAN
UNION, IT HAS TO GO THROUGH THE
WHOLE PROCESS ALL OVER AGAIN.
THERE WAS AN EFFORT TO HARM
YNIZE REGULATIONS SO RESEARCH
DONE IN ONE JURISDICTION COULD
BE ACCEPTED BY ANOTHER
JURISDICTION BY THE REGULATORY
AUTHORITIES.
ICH DOCUMENTS HAS MULTIPLE,
MULTIPLE VOLUMES ABOUT MULTIPLE
THINGS RELATED HOW TO DO
CLINICAL RESEARCH AND ONE
IMPORTANT GUIDANCE FROM HOW TO
DO RESEARCH EDGE KALILY IS THE
GOOD CLINICAL PRACTICE
GUIDELINES AND THAT HAS BECOME
IN MANY JURISDICTIONS AROUND THE
WORLD THE GUIDING REGULATORY
FRAMEWORK FOR HOW RESEARCH IS
DONE IN THAT JURISDICTION.
SO IN ADDITION TO CODES AND
GUIDELINES WE HAVE REGULATIONS.
IN THE UNITED STATES, WE HAVE
THE COMMON RULE, WHICH IS A SET
OF REGULATIONS ABOUT HOW TO
PROTECT PARTICIPANTS IN RESEARCH
THAT IS ADOPTED AND HAS BEEN
ADOPTED BY 17US FEDERAL
AGENCIES.
ONE OF WHICH IS THE DEPARTMENT
OF HEALTH AND HUMAN SERVICES AND
DEPARTMENT OF HEALTH AND HUMAN
SERVICES WHICH IS THE AGENCY
THAT NIH BELONGS TO.
IT USES THE COMMON RULE THAT IS
FOUND AT US45 CODE OF FEDERAL
REGULATIONS.46.
YOU KNOW, YOU MIGHT SAY WHO
CARES ABOUT THAT.
YOU WILL FIND AROUND HERE FOR
EXAMPLE, PEOPLE SAY WHAT IS
45CFR46 SAY?
YOU HAVE TO KNOW WHAT IT MEANS.
THAT IS THE COMMON RULE.
INTERESTINGLY, THE FDA, FOOD AND
DRUG ADMINISTRATION HAS THEIR
OWN SET OF REGULATIONS THAT ARE
NOT -- THEY DON'T -- THEY DON'T
FALL UNDER THE COMMON RULE AND
HAVE A SET OF REGULATIONS --
SEVERAL SETS OF REGULATIONS
RELEVANT TO ETHICS OF DOING
RESEARCH AND MOST RELEVANT ARE
PROBABLY ONES FOUND AT 24CFR50
AND 56.
THEY ARE VERY SIMILAR TO WHAT
YOU SEE IN 45CFR46 AND NOT
IDENTICAL AND IMPORTANT TO THINK
ABOUT DIFFERENCES THERE AND IF
SOMEBODY IS DEVELOPING A PRODUCT
THAT WILL ULTIMATELY WANT TO
APPLY FOR FDA APPROVAL, THEY
HAVE TO FOLLOW FD REGS.
IN ADDITION TO REGULATIONS THAT
GOVERN AGENCIES, THERE ARE OFTEN
OR MAYBE USUALLY INSTITUTIONAL
POLICIES THAT PEOPLE HAVE TO
ADHERE TO.
NIH, FOR EXAMPLE, HAS A NUMBER
OF POLICIES ABOUT WHO TO INCLUDE
AND HOW RESEARCH OUGHT TO BE
DONE EDGE KALILY THAT ARE
RELEVANT TO RESEARCH FUNDED BY
OR DONE WITHIN THE NIH.
AND HOLLY MENTIONED EARLIER THAT
MOST OF OUR FOCUS IS DOMESTIC.
MANY RESEARCH PROJECTS IN THESE
-- IN THIS DAY ARE DONE ACROSS
BORDERS.
THERE ARE LAWS AND REGULATIONS
IN MANY, MANY OTHER
JURISDICTIONS THAT ARE ALSO
RELEVANT.
IF SOMEBODY IS DOING RESEARCH
FUNDED BY NIH, IT DOESN'T MATTER
WHERE IT IS BEING DONE THEY HAVE
TO FOLLOW STILL NIH RULES AND
MAY ALSO HAVE TO FOLLOW LAWS AND
REGULATIONS OF JURISDICTION IN
WHICH THEY ARE CONDUCTING
RESEARCH.
SO LOTS OF DETAILS.
I WENT OVER THAT PRETTY FAST.
I WANT TO FOCUS A MOMENT ON WHAT
THE BELMONT REPORT DOES INCLUDE.
I THINK I MENTIONED IT IS NOT A
CODE IN THE SAME WAY AS THE
OTHERS BUT HAS ETHICAL
PRINCIPLES UNDERLYING CONDUCT OF
RESEARCH AND EXPLICATES THEM AND
WHAT THEY ARE AND HOW THEY APPLY
AND RESPECT FOR PERSONS APPLYING
TO PROCESS OF INFORMED CONSENT
AND BENEFICENCE -- AND JUSTICE
TO PROCESS OF SELECTING
PARTICIPANTS FAIRLY AND WILL
HEAR ABOUT ALL THOSE MORE AND
OTHER THING AND IMPORTANT THING
I THINK THAT THE BELMONT REPORT
DOES AND VERY FEW OF THE OTHER
DOCUMENTS DO IS DESCRIBE THE
DISTINCTION AND BOUNDARIES
BETWEEN CLINICAL PRACTICE AND
CLINICAL RESEARCH.
AND INTERESTINGLY, WHEN YOU
THINK ABOUT THE KINDS OF ETHICAL
ISSUES OR TENSIONS THAT COME UP
IN A CLINICAL RE-ENVIRONMENT,
THEY OFTEN ARE BECAUSE OF
TENSION OR CONFUSION ABOUT THESE
BOUNDARIES AND WANT TO SPEND A
MINUTE TALKING ABOUT WHAT I MEAN
BY THAT.
DIFFERENCE BETWEEN CLINICAL
RESEARCH AND PRACTICE IS
MULTIFOLD.
FIRST OF ALL, THERE ARE
DIFFERENT GOALS THAT I MENTIONED
THAT GOAL OF RESEARCH IS
ANSWERING GENERALIZABLE
QUESTIONS AND GOAL OF
[INDISCERNIBLE] IS HELPING
PEOPLE IN FRONT OF YOU BASED ON
EVIDENCE THAT SOMEBODY COLLECTED
BEFORE.
WE ALSO USE DIFFERENT METHODS
AND IN RESEARCH YOU MIGHT BE
AWARE AND HEAR MORE ABOUT AND WE
RANDOMIZE PEOPLE TO GET THIS OR
THAT DRUG AND BLIND THEM MEANING
THEY ARE NOT ALLOWED TO KNOW
WHAT THEY ARE GETTING AND
INVESTIGATOR DOESN'T KNOW WHAT
THEY ARE GETTING EITHER THAT IS
A DOUBLE BLIND AND OFFER AS
PLACEBOS ONE PART OF A CONTROL
GROUP THAT IS COMMON IN RESEARCH
AND DO DOSE ESCALATION IN TRIALS
AND THESE THREE PEOPLE WILL GET
THIS DOSE AND NEXT THREE PEOPLE
A HIGHER DOSE AND IS A NUMBER OF
REALLY IMPORTANT METHODOLOGIES
IN RESEARCH THAT ARE CRITICAL TO
GETTING GOOD UNBIASED DATA YOU
WOULD FIND ANNAGE MA IN CLINICAL
PRACTICE AND GOING TO DOCTOR'S
OFFICE WITH A SORE THROAT AND
DOCTOR SAID I WILL GIVE YOU A
DRUG BUT I WON'T TELL YOU WHAT
IT IS I DON'T KNOW WHAT IT IS
YOU WOULD BE LIKE I THINK I NEED
A NEW DOCTOR AND THERE IS A
REALLY INTERESTING DICHOTOMY
BETWEEN METHODS COMMON TO EACH
OF THOSE DOMAINS.
THERE IS ALSO DIFFERENT
JUSTIFICATIONS FOR RISK.
IN CLINICAL PRACTICE, CERTAINLY
PEOPLE ABSORB AND ACCEPT
WHATEVER RISK.
THERE IS RISKS WITH
INTERVENTIONS OF ALL KINDS AND
THOSE RISKS ARE JUSTIFIED
BECAUSE THEY -- THEY BENEFIT
THAT IS PRESUMED TO BE HAPPENING
BY GIVING THIS INTERVENTION
OUTWEIGHS THE RISK.
SO THE RISK IS WORTH IT FOR THAT
INDIVIDUAL.
IN RESEARCH, WE ASK PEOPLE
SOMETIMES TO DO THINGS FOR WHICH
THERE ARE NO BENEFITS THEN.
WE MAY ASK THEM, FOR EXAMPLE, TO
HAVE AN EXTRA BIOPSY OR EXTRA
BLOOD DRAW OR X-RAY AND TAKE A
DRUG TO GET A PHARMACOKINETIC
READING ON IT.
THOSE ARE THINGS DONE FOR MONTH
BENEFIT TO INDIVIDUALS AND THEY
ACCEPT RISKS FOR INTEREST OF
SCIENCE.
THERE ARE DIFFERENT LEVELS OF
UNCERTAINTY AND NOT EVERYTHING
IN CLINICAL PRACTICE IS CERTAIN
FOR SURE.
PEOPLE WE OFTEN HAVE TO SAY HERE
IS WHAT WE KNOW OR DON'T KNOW
AND WHAT WE WILL TRY AND FOR
MOST PART IN CLINICAL PRACTICE
WHAT IS DONE IS BASED ON PRIOR
EVIDENCE OR PRIOR EXPERIENCE OR
STANDARDS IN THE COMMUNITY AND
IN RESEARCH, STARTING POINT IS
UNCERTAINTY AND IN OTHER WORDS
WE WOULDN'T DO A CLINICAL TRIAL
AND WE ARE TESTING A VERSUS B
AND KNOW A IS BETTER WHY WOULD
WE DO THE TRIAL?
STARTING POINT IS WE DON'T KNOW
WHICH IS BETTER, SAFER, OR MORE
EFFECTIVE OR WHATEVER.
THAT IS THE STARTING POINT AND
DIFFERENCES IN GOALS METHODS
JUSTIFICATION FOR RISK AND
LEVELS UNCERTAINTY WE HAVE
DIFFERENT OBLIGATIONS OF
PLAYERS, IF YOU WILL.
CLINICIANS HAVE OBLIGATION TO
COMPETENTLY OFFER CARE AND
TREATMENT IN THEIR PATIENT'S
BEST INTEREST AND IS THEIR
OBLIGATION.
RESEARCHERS HAVE OBLIGATION TO
CONFIDENTLY CONDUCT RESEARCH
WHILE REINSPECTING RIGHTS AND
WELFARE OF THEIR PARTICIPANTS
AND VERY DIFFERENT OBLIGATIONS
AS WELL.
NOW YOU GET TO THIS POINT IN MY
TALK. YOU WILL SAY, WHOA. THAT
IS A LOT OF STUFF AND DOESN'T
MAKE ANY SENSE.
I THINK OFTEN TIMES FOR
INVESTIGATORS AND PEOPLE
INVOLVED IN RESEARCH AND PEOPLE
THAT ARE ON IRBS ARE LIKE, OKAY.
SO HOW DO WE KNOW?
HOW DO WE REALLY KNOW WHAT TO
DO?
DO WE FOLLOW THE COMMON RULE OR
FOLLOW THE DECLARATION OF
HELSINKI OR HAVE TO KNOW BOTH OR
WHAT IF THEY CONFLICT AND HOW DO
WE FIGURE OUT WHAT TO DO?
THERE IS LOTS UNFORTUNATE
CONFUSION.
TO ADD TO THAT, A LOT OF THE
GUIDANCE THAT I HAVE MENTIONED
AND RULES AND REGULATIONS AND
CODES OF ETHICS WERE DEVELOPED
IN RESPONSE TO A PARTICULAR
HISTORICAL EVENT.
SO AS I MENTIONED, NUREMBERG WAS
A RESPONSE TO NAZI GERMANY AND
HELSINKI RESPONSE TO NUREMBERG
CODE AND BELMONT RESPONSE TO
TUSKEGEE AMONG OTHER THINGS AND
EACH OF THEM SORT OF CAME ABOUT
HISTORICALLY BECAUSE OF
SOMETHING THAT HAD HAPPENED AND
THEREFORE THEIR MAIN FOLK --
FOCUS IS OFTEN IN RESPONSE TO
THAT HISTORICAL EVENT.
THE END RESULT IS THAT DIFFERENT
REGULATIONS AND GUIDANCE COMES
SOMETIMES INTO CONFLICT AND HAVE
DIFFERENT INTERPRETATIONS OR
EMPHASIZE DIFFERENT THINGS AND
UNDERSTANDING THEM IS DIVERGENCE
AND MENTIONED ALREADY THAT
DIFFERENT REGULATIONS MIGHT
APPLY AND FOR EXAMPLE IF
NIH-FUNDED INVESTIGATOR, YOU ARE
-- YOU HAVE TO FOLLOW COMMON
RULE.
IF NIH INVESTIGATOR DEVELOPING A
PRODUCT YOU WANT TO ULTIMATELY
GET APPROVED BY FDA YOU HAVE TO
FOLLOW FDA REGULATIONS
INVESTIGATOR FOLLOWING COMMON
RULE OF FDA REGULATIONS AND WANT
PAPER PUBLISHED IN JOURNAL YOU
HAVE TO FOLLOW DECLARATION OF
SIN CAN I.
YOU HAVE TO KNOW WHAT IT IS AND
ALL THESE ARE IMPORTANT TO KNOW
ABOUT AND NOW I WILL TAKE YOU TO
A DIFFERENT PLACE AND THINK THAT
RECOGNIZING NUMBER OF DIFFERENT
GUIDANCES REGULATIONS AND
CONFUSION THEY MIGHT GENERATE
LED US 20-SOME ODD YEARS AGO TO
DEVELOP WHAT WE CALL SYSTEMATIC
COHERENT UNIVERSALLY APPLICABLE
FRAMEWORK THAT IS FRAMEWORK YOU
WILL LEARN ABOUT AND HEAR ABOUT
REPEATEDLY THROUGHOUT THE COURSE
AND FRAMEWORK HAS EIGHT
PRINCIPLES SEE WHAT THEY ARE
COLLABORATIVE PARTNERSHIP AND
FAIR SUBJECT OR PARTICIPANT
SELECTION FAVORABLE RISK BENEFIT
INDEPENDENT REVIEW INFORMED
CONCEPT AND R--EE INSPECT FOR
ENROLLED SUBJECTS.
I WILL BRIEFLY SAY WHAT EACH OF
THEM MEAN AND WHY WE THINK IT IS
IMPORTANT AND SOME CHALLENGES
WITH IT.
COLLABORATIVE PARTNERSHIP,
BASICALLY IF THE GOAL OF
RESEARCH IS TO TRY TO IMPROVE
HEALTH WE HAVE TO REALIZE IT
SHOULD BE A PARTNERSHIP WITH THE
RELEVANT PARTNERS AND THOSE, FOR
EXAMPLE, WHO ARE RESPONSIBLE FOR
PLANNING CONDUCTING AND
OVERSEEING RESEARCH INTEGRATING
RESULTS OF RESEARCH INTO A
HEALTH SYSTEM AND CONTRIBUTION
OF VARIOUS PARTNERS INVOLVED AND
COLLABORATION WITH EXISTING
SYSTEMS OF HEALTH THAT MEANS
COLLABORATING WITH POLICY MAKERS
AND HEALTH SYSTEMS AND COMMUNITY
ADVISORY BOARDS OR COMMUNITIES
AND PATIENT ADVOCATES AND
ADVOCATES FOR RESEARCH FUNDING
AND COLLABORATING INVESTIGATORS
PRACTICING CLINICIANS,
PARTICIPANTS, THE LIST COULD GO
ON AND THINKING ABOUT WHO ARE
IMPORTANT PARTNERS IN ANY
RESEARCH ENDEAVOR SO RESEARCH IS
RESPONSIVE TO WHAT PARTNERS NEED
AND RESPECTS CONTRIBUTIONS OF
EACH.
THERE IS LOTS OF EXAMPLES OF
COLLABORATIVE PARTNERSHIP AND
SOME PROBABLY MORE EFFECTIVE
THAN OTHERS AND MANY STUDIES
HAVE COMMUNITY ADVISORY BOARDS
AND ARE MANY ADVOCACY GROUPS AND
LIKE RARE -- ADVOCACY FOR RARE
DISEASES AND FRIENDS OF CANCER
AND CLINICAL HAS PATIENT
ADVISORY GROUP AND DIFFERENT
EXAMPLES OF COLLABORATION THAT
MAKES SENSE AND COLLABORATION IS
ALSO COMPLEX.
IF YOU GO, FOR EXAMPLE, TO A
RECENT ISSUE OF THE NEW ENGLAND
JOURNAL AND LOOK AT RANDOMIZED
TRIALS THAT MIGHT BE REPORTED IN
THERE YOU WILL SOMETIMES SEE A
STUDY THAT HAS 40 AUTHORS DONE
IN 83 COUNTRIES WITH 6 HUNDRED
SITES AND 10 THOUSAND PEOPLE.
THAT IN ONE WAY THEY ARE ALL
COLLABORATORS THAT IS A COMPLEX
MESS OF PEOPLE TO FIGURE OUT HOW
TO COLLABORATE WITH AND IS
CHALLENGING AND CHALLENGES ARE
IDENTIFYING WHO PARTNERS ARE AND
WHO RIGHT PARTNERS ARE AND HOW
TO ENGAGE THEM.
THERE IS INFORMATION AND LOTS OF
LITERATURE NOW ON PATIENT
ENGAGEMENT PUBLIC ENGAGEMENT AND
COMMUNITY-BASE ENGAGEMENT AND
IMPORTANT CONCEPTS REALLY BUT
ALL OVER THE MAP IN TERMS WHAT
THAT MODE ENGAGEMENT LOOKS LIKE.
SECOND VALUABLE PRINCIPLE WE
TALK ABOUT IN WORLD AS SOCIAL
VALUE AND THIS BASICALLY WHAT IT
IS, IS THE QUESTION HAS TO BE
WORTH ASKING AND WILL WE LEARN
SOMETHING USEFUL TO SOMEBODY AND
GOAL IS TO FIND USEFUL
INFORMATION TO UNDERSTAND OR
IMPROVE HUCHL AN HEALTH QUESTION
WE ARE ASKING IN THIS STUDY OR
PROGRAM OF RESEARCH GOING TO DO
THAT?
SHOULD ANSWER VALUABLE
QUESTION, ONE THAT CAN OR WILL
GENERATE NEW KNOWLEDGE OR
UNDERSTANDING ABOUT HUMAN HEALTH
OR ILLNESS THAT COULD BE
SOCIALLY VALUABLE, CLINICALLY
VALUABLE OR SCIENTIFICALLY
VALUABLE.
WE OFTEN ASK, YOU KNOW, THEN
WHAT IS THE VALUE OF ANSWERING A
SPECIFIC QUESTION?
NOT ALWAYS SO EASY TO JUDGE BUT
THINKING CAREFULLY ABOUT WHAT WE
WILL LEARN AND HOW USEFUL IT
WILL BE AND HOW WILL WE KNOW IF
IT IS USEFUL AND TO WHOM WILL
KNOWLEDGE BE USEFUL?
IS IT TO PARTICIPANTS IN THE
STUDY?
SOMETIMES IT IS.
SOMETIMES IS IT TO COMMUNITY
WHICH THEY LIVE OR PEOPLE TO
SIMILAR CONDITIONS OR FUTURE
PEOPLE OR SOCIETY IN GENERAL OR
SCIENCE AND SPONSORS AND COULD
BE LOTS OF ANSWERS TO THE
QUESTION AND TRYING TO FIGURE
OUT WHAT VALUE IS OF A SPECIFIC
STUDY.
THERE IS ROOM FOR MORE WORK ON
THIS TOPIC.
THERE IS A, I THINK A VERY
IMPORTANT ISSUE OF BIOEDGE INGS
OF EIGHT YEARS AGO TRYING TO ASK
THE QUESTION ABOUT, YOU KNOW,
WHAT IS REALLY SOCIAL VALUE AND
HOW DO WE UNDERSTAND IT?
A NUMBER OF IMPORTANT QUESTIONS
AND PAPERS IN THAT VOLUME.
THIS IS ONE FROM PEOPLE IN OUR
GROUP WHO WERE DEFENDING SOCIAL
VALUE REQUIREMENT.
ANOTHER FROM A PERSON IN OUR
GROUP WHO WAS QUESTIONING SOCIAL
VALUE REQUIREMENT AND THINKING
ABOUT THE LIMITS OF IT.
PEOPLE HAVE BUILT ON THIS.
THERE WAS A VERY USEFUL PAPER IN
THE HASTINGS CENTER IN 2018 BY
DANY WHO TALKED ABOUT, YOU KNOW,
HOW TO THINK ABOUT SOCIAL VALUE
IN A DIFFERENT WAY.
THERE HAVE BEEN PEOPLE LIKE ONE
OF MY FELLOWS. I WROTE A PAPER
OR CHAPTER FOR A BOOK RECENTLY
TRYING TO SELECT CASES AND
EXEMPLIFY WHAT VALUE MEANS IN
SPECIFIC CASES AND PICKED HIGH
VALUE CASES AND LOW VALUE CASES
AS AN EXPLORATION.
SO THAT IS A LOT MORE TO BE DONE
ABOUT WHAT SOCIAL VALUE IS.
YOU WILL HEAR IT THROUGHOUT THIS
COURSE.
THIRD IS VALID SCIENTIFIC
METHODOLOGY.
YOU HAVE PARTNERS IN PLACE AND
QUESTION THAT IS WORTH ASKING.
NEXT REAL IMPORTANT ETHICAL
REQUIREMENT IS SETTING UP THE
STUDY SO THAT IT IS VALID AND
YOU GET RELIABLE,
UNDERSTANDABLE, INFORMATION THAT
YOU CAN MAKE SENSE OUT OF AND
YOU CAN ANSWER THE QUESTION.
THAT DOESN'T MEAN IT HAS TO BE A
POSITIVE TRIAL.
IT JUST MEANS YOU HAVE TO BE
ABLE TO KNOW WHAT THE ANSWER TO
THE QUESTION IS. EXCUSE ME.
WHEN YOU ARE DONE.
THAT INCLUDES A BUNCH OF THINGS
LIKE HOW TO DESIGN THE TRIAL AND
WHAT METHODS WILL BE THAT YOU
WILL USE AND WHAT STATISTICS
WILL YOU BE USING AND WHAT
STATISTICAL POWER.
THE GOAL BEING VALID, RELIABLE,
GENERALIZABLE, AND INTERPRETABLE
DATA.
THERE IS ALSO AN IMPORTANT PART
OF VALID SCIENTIFIC METHODOLOGY
THAT IS FEASIBILITY.
SOME QUESTIONS CAN'T BE ANSWERED
BECAUSE YOU CAN'T DESIGN THE
STUDY IN A WAY THAT WILL EVER
COME UP WITH AN ANSWER.
MAKING SURE THAT WHAT YOU ARE
ASKING AND HOW YOU ARE DESIGNING
IT IS FEASIBLE IS AN IMPORTANT
PART OF JUSTIFYING ASKING PEOPLE
TO PARTICIPATE.
SOMETIMES WHEN WE TALK ABOUT
SCIENTIFIC METHODOLOGY AS AN
ETHICAL REQUIREMENT PEOPLE SAY
THAT IS SCIENCE NOT ETHICS.
MY SLIDE HERE IS TO TELL YOU YOU
CAN'T PULL THEM APART.
THEY ARE TOTALLY INTEGRATED AND
ONLY TO MAKE SOMETHING ETHICALLY
OKAY HAS TO BE SCIENTIFICALLY
RIGOROUS AND SOMETHING THAT IS
SCIENTIFICALLY RIGOROUS SHOULD
BE ETHICAL AS WELL AND IS A
NUMBER OF DIFFERENT
CONSIDERATIONS IN THINKING ABOUT
SCIENTIFIC VALIDITY.
THESE ARE JUST SOME EXAMPLES.
CHOOSING THE ENDPOINTS, YOU
KNOW, HOW DO YOU MEASURE A --
THE EFFECT OF AN ANTIVIRAL OR
VACCINE?
IS IT ANTIBODIES, INFECTION OR
DISEASE AND MATTERS IN NUMBER OF
PEOPLE YOU NEED AND UNCERTAINTY
AT END OF THE STUDY, ET CETERA.
WHEN DO YOU USE RANDOMIZED
DOUBLE BLIND PLACEBO CONTROLLED
TRIAL AND MAKING TRIALS
NONINFERIORITY OR SUPERIORITY
AND USING QUANTITATIVE OR
QUALITATIVE METHOD AND MEASURING
OUTCOME AND WHAT IS MEASURE OF
OUTCOME TO BUILD INTO A STUDY
AND HOW DO YOU FOLLOW PEOPLE AND
WHAT POWER DO YOU NEED AND
SAMPLE SIZES AND WHAT METHODS OR
STATISTICAL METHODS DO YOU NEED,
ET CETERA.
THOSE ARE INTERESTING AND
IMPORTANT QUESTIONS THAT HAS
BEEN CARTOONS OWE TLUT AND
CONTROL GROUP AND OUT OF CONTROL
GROUP AND PLACEBO MEMBER WHO
DIED AND MEMBER PLACEBO GROUP
AND THIS ONE I THINK IS REALLY
FUN.
YOU KNOW, THE -- THE POSSIBLE
WOES OF STATISTICS THAT CAN BE
MISUSED.
ALL THAT IS IMPORTANT.
THERE IS ALSO REALLY INTERESTING
CHALLENGES RIGHT NOW THAT WE ARE
SORT OF LEARNING MORE ABOUT.
DECENTRALIZED TRIALS AND
PRAGMATIC TRIALS AND PLATFORM
TRIALS AND SECONDARY ANALYSIS OF
DATA OR SPECIMENS THAT ALL OF
WHICH HAVE METHODS THAT ARE
DIFFERENT FROM SORT OF STANDARD
ONE IN-PERSON RANDOMIZED CONTROL
TRIAL.
BUT REQUIRES VERY CAREFUL
THOUGHT ABOUT HOW TO SET IT UP
SO IT IS RIGOROUS AND VALID AND
YOU WILL GET INTERPRETABLE DATA
AND FEASIBLE.
YOU WILL HEAR ABOUT SOME OF
THESE.
I DON'T HAVE TIME TO GO OVER
THEM TODAY.
FAIR SUBJECT SELECTION OR
PARTICIPATANT SELECTION IS
BASICALLY WHAT IT SOUNDS LIKE
AND MAIN ISSUE IS THAT THE
SCIENTIFIC OBJECTIVES SHOULD
GUIDE INCLUSION CRIT EAR YA AND
RECRUITMENT STRATEGIES AND
SELECTION.
THIS IS BASED -- YOU KNOW, SOME
OF THIS IS IN THE BELMONT REPORT
BASED ON A RESPONSE TO PREVIOUS
KINDS OF RESEARCH THAT WERE DONE
WHERE PRIVILEGE OR EASY
AVAILABILITY OR VULNERABILITY
WERE USED AS CRATE EAR YA FOR
SELECT PARTICIPANTS THAT ARE ALL
WRONG CRITERIA.
THERE IS A DAVE THAT YOU WILL
HEAR FROM THE COURSE TALKS ABOUT
FLIPPING IT ON ITS SIDE SAYING
BEST WAY TO THINK ABOUT FAIR
PARTICIPANT SELECTION IS TO SAY
THERE IS NO EXCLUSION.
EVERYBODY IS ELIGIBLE WITHOUT
JUSTIFICATION.
SO THEN YOU MIGHT SAY, WHAT ARE
JUSTIFICATIONS THAT SOMETIMES
COULD BE USED TO EXCLUDE PEOPLE?
SOMETIMES THEY ARE
SCIENTIFICALLY INAPPROPRIATE AND
CAN'T STUDY TREATMENT IN PEOPLE
WITH BREAST CANCER THAT DON'T
HAVE BREAST CANCER.
FOR EXAMPLE SOMETIMES IT IS RISK
AND CONTENTIOUS AND IMPORTANT
AND RISK IS HIGH FOR CERTAIN
GROUP OF PEOPLE IT IS MAYBE
APPROPRIATE AND JUSTIFIABLE TO
EXCLUDE THEM AND EVEN MORE
CONTROVERSY ABOUT VULNERABILITY
AND SOME PEOPLE SAY YOU SHOULD
EXCLUDE PEOPLE THAT ARE
VULNERABLE AND WILL TALK ABOUT
IT IN A MINUTE. IT IS
CONTENTIOUS.
IT IS PART OF FAIR PARTICIPANT
SELECTION THAT HAS US THINK
ABOUT HOW TO FAIRLY DISTRIBUTE
HARMS AND BENEFITS OF RESEARCH
AND IN OTHER WORDS DON'T ALWAYS
PICK SAME PEOPLE OVER AND OVER
AGAIN THAT THEN ACCEPT ALL OF
THE RISKS WITHOUT GETTING
BENEFITS OR SELECT A GROUP THAT
WILL ALWAYS TAKE RISKS WHEN
BENEFITS GO TO SOMEBODY ELSE.
THOSE KINDS OF CONSIDERATIONS
ARE IMPORTANT AT THE FRONTEND IN
SELECTING PARTICIPANTS.
AND I MENTIONED THIS EARLIER.
THERE IS A REALLY INTERESTING
SWITCH THAT HAS HAPPENED OVER
TIME WHERE BOTH OF THESE END UP
BEING IMPORTANT.
THEY ARE REALLY HISTORICALLY
SITUATED IN DIFFERENT WAYS AND
RESEARCH WAS SEEN FOR A LONG
TIME AS A BURDEN.
PARTICIPANTS NEED PROTECTION
FROM THAT BURDEN OR FROM THE
RISK.
AS I MENTIONED EARLIER IF SEEN
AS A BENEFIT, PEOPLE NEED ACCESS
TO RESEARCH.
BOTH OF THESE ARE STILL TRUE.
THE PENDULUM SWINGS BACK AND
FORTH A LITTLE BIT BETWEEN THE
TWO AND MENTIONED PROTECTING
VULNERABLE GROUPS AND PROTECTION
ABOUT WHAT VULNERABILITY MEANS
ACTUALLY IN THE CONTEXT OF
RESEARCH AND IF WE PROTECT
PEOPLE TOO MUCH WE KEEP THEM OUT
OF -- PREVENT THEM FROM GETTING
BENEFITS OF RESEARCH AND I'M NOT
SURE IF THERE IS ANOTHER SESSION
ON VULNERABILITY AT ALL?
>> NOT SPECIFICALLY.
>> CHILDREN, OKAY. THERE IS
REALLY CHALLENGES TO SELECTING
APPROPRIATE PARTICIPANTS FOR A
STUDY AND FOR EXAMPLE THIS IS
ONE THAT COMES UP ALL THE TIME.
IS IT PREFERABLE TO TOUCH AN
EARLY PARTICULARLY RISKY THERAPY
IN HEALTHY AFFECTED ADULTS THAT
CAN GIVE THEIR OWN CONSENT OR IN
SEVERELY ILL INFANTS OTHERWISE
LIKELY TO DIE AS INFANTS IF THEY
DON'T GET SOMETHING SMA WORKS
AND REAL DILEMMA HAPPENED IN
STUDIES AND ANOTHER EXAMPLE OF
CHALLENGE IS WHEN YOU ENROLL
PREGNANT PEOPLE IN RESEARCH AND
ANOTHER TOPIC THAT COULD TAKE A
WHOLE LECTURE AND SOMETIMES
DOES.
NEXT ELEMENT IS FAVORABLE RISK
BENEFIT.
THE QUESTIONS REALLY ASK ARE
RISKS TO SUBJECTS NECESSARY AND
MINIMIZED TO EXTENT POSSIBLE AND
IS A JUDGMENT THAT ALL OF US
HAVE TO MAKE AS INVESTIGATORS
RESEARCH TEAMS IRB MEMBERS AND
PARTICIPANTS AND ARE RISKS
JUSTIFIED BY EITHER BENEFIT TO
THE INDIVIDUAL OR SOCIAL VALUE
OF THE STUDY?
THAT IS A -- YOU KNOW, IN
COMMENSURATE SOME PEOPLE SAY
EVALUATION BUT IMPORTANT ONE TO
MAKE.
MANY ARGUE FOR THE NEED ALSO TO
ENHANCE BENEFITS.
IMPORTANTLY, AS BELMONT REPORT
POINTS OUT AND MENTIONED ALREADY
A COUPLE OF TIMES SOMETIMES
INTERESTS OTHER THAN THOSE OF
THE SUBJECTS AND IN OTHER WORDS
PARTICIPANTS OF STUDY CAN
JUSTIFY RISKS AS LONG AS RIGHTS
OF PARTICIPANTS HAVE BEEN
PROTECTED.
LOTS OF CHALLENGES.
ONE, HOW DO YOU IDENTIFY WHICH
RISKS AN PD BENEFITS COUNT AND
HAS BEEN LOTS OF INTERESTING
DEBATE ABOUT IN SOME GUIDANCE IT
SAYS WE SHOULD CONSIDER
PHYSICAL, PSYCHOSOCIAL AND
ECONOMIC AND LEGAL RISKS AND WE
DON'T CONSIDER PHYSICAL,
PSYCHOSOCIAL, ECONOMIC AND LEGAL
BENEFITS AND HOW DO WE DEAL WITH
THAT AND MINIMIZE RISK SNZ.
YOU WILL HEAR FROM SOME OTHERS
THAT IN -- IN PROTECTING CERTAIN
GROUPS OF PEOPLE, ONE STRATEGY
THAT WE USE IS BY REGULATION.
WE LIMIT AMOUNT OF RISKS THAT
PEOPLE CAN BE EXPOSED TO AND
HAPPENS WITH CHILDREN WITH
PREGNANT PERSONS AND WITH
PRISONERS AND THERE IS A HUGE
DEBATE ABOUT DIRECT VERSUS
INDIRECT BENEFITS.
DIRECT BENEFITS AS THE KIND OF
BENEFIT JUSTIFYING CERTAIN
AMOUNT OF RISKS AND INDIRECT
BENEFITS MONEY OR ACCESS TO GOOD
CLINICIANS OR ACCESS TO OTHER
KINDS OF CARE MAY NOT BE KINDS
OF BENEFIT YOU WANT TO JUSTIFY A
RISK BASED ON AND THEY STILL
HAPPEN IN RESEARCH.
DETERMINING THAT LEVEL IS A
CHALLENGE.
TWO MORE.
THREE MORE, I GUESS.
INDEPENDENT REVIEW IS ENSURING
REGULATORY AND ETHICAL
REQUIREMENTS HAVE BEEN FULFILLED
AND IS A PROCESS THAT CHECKS
INVESTIGATOR BIASES AND
CONFLICTS AND ENSURES PUBLIC
THAT RESEARCH IS NOT EXPLOITING
INDIVIDUALS OR GROUPS AND YOU
WILL LEARN MORE ABOUT IRBS LATER
TODAY.
I WANTED TO PUT UP REGULATORY
CRITERIA BOTH IN 45CFR AND
21CFR56.
YOU CAN SEE THAT THEY MIMIC A
LOT OF WHAT I ALREADY SAID.
RISKS ARE MINIMIZED AND
JUSTIFIED BY ANTICIPATED
BENEFITS EVEN IF AREN'T ANY TO
PARTICIPANTS AND FAIR SUBJECT
SELECTION AND THEN INFORMED
CONSENT IS ADEQUATE.
OUR NEXT I FORGOT ABOUT THIS.
TWO REGULATORY BODIES TO KNOW
ABOUT OFFICE OF HUMAN RESEARCH
PROTECTIONS THAT IS THE
DEPARTMENT OF HEALTH AND HUMAN
SERVICES OFFICE THAT OVERSEES
RESEARCH FUNDED BY HHS AND WE
HAVE AN INTRAMURAL OFFICE OF
HUMAN SUBJECTS RESEARCH
PROTECTION THAT IS THE
FEDERALWIDE ASSURANCE HOLDER FOR
THE INTRAMURAL PROGRAM.
I WILL SKIP THAT.
NEXT ONE IS INFORMED CONSENT.
THIS IS BASICALLY A PROCESS THAT
ENSURES INDIVIDUALS HAVE AN
OPPORTUNITY TO DECIDE WHETHER
THEY WANT TO PARTICIPATE OR
CONTINUE TO PARTICIPATE AND
WHETHER IT IS COMPATIBLE WITH
THEIR GOALS AND INTERESTS AND
VALUES AND MANY PEOPLE WHEN WE
FIRST PUT OUT THIS FRAMEWORK
SAID, YOU KNOW, WHAT MAKES
CLINICAL R- HE SEARCH ETHICAL?
EVERYBODY SAYS INFORMED CONCEPT
THAT YOU CAN SEE IS 7TH ON LIST
OF 8 PRINCIPLES AND POINT BEING
THAT YOU DON'T ASK PEOPLE TO
PARTICIPATE UNTIL ALL OF THE
OTHER THINGS ARE SATISFIED.
YOU HAVE TO HAVE A GOOD QUESTION
OR VALID SCIENCE AND SCIENTIFIC
METHODOLOGY AND MAKE SURE YOU
UNDERSTAND RISKS AND BENEFITS
HAVING AN INDEPENDENT REVIEW
BEFORE INVITE PEOPLE TO
PARTICIPATE.
INFORMED CONSENT HAS LOTS OF
PIECES AND I'M COMING NEXT WEEK
TO SPEAK TO YOU IN MORE DEPTH
ABOUT IT AND WILL SKIP IT FOR
NOW AND LOTS OF INTERESTING
CHALLENGES NOW IN TERMS OF
INFORMED CONCEPT AND FOCUSING ON
LONGSTANDING PROBLEMS AND
QUANTITY OF INFORMED CONSENT AND
HOW TO ASSESS CAPACITY CONCEPT
AND LOTS OF CHANGES ALSO IN HOW
WE OBTAIN INFORMED CONCEPT NOW
AND SOME IS BASED ON CHANGES IN
RESEARCH METHODS.
THE EIGHTH OF THE PRINCIPLES IS
WHAT IS CALLED RESPECT FOR
ENROLLED PARTICIPANTS THAT IS
PROBABLY ANOTHER ONE THAT NEEDS
A LOT OF ATTENTION AND WHAT I
MEAN BY IT.
EARLY ON WHEN WE DEVELOPED THE
FRAMEWORK, THERE WAS AN IDEA AS
I MENTIONED THAT PEOPLE SAY WHAT
MAKES CLINICAL RESEARCH ETHICAL
AND GET IRB TO REVIEW IT AND GET
PERSON'S INFORMED CONSENT AND
ETHICS IS DONE AND ETHICS MAKES
NO SENSE AT ALL BEGINNING OF
TRIAL YOU ARE BEGINNING TO
ENGAGE WITH PEOPLE THAT ARE IN
THE STUDY AND YOU HAVE
RESPONSIBILITIES AND ETHICAL
RESPONSIBILITIES TO THOSE PEOPLE
AND YOU HAVE ETHICAL
RESPONSIBILITIES TO THE -- YOU
KNOW, THE WORLD IN TERMS OF
REPORTING YOUR DATA AND SCIENCE.
THERE IS A LOT THAT HAPPENS
AFTER INFORMED CONCEPT IS
OBTAINED THAT IS A PARTIAL LIST
AND IT IS PROTECTING
CONFIDENTIALITY AND MONITORING
WELFARE AND RIGHT TO WITHDRAW
AND PROVIDING INFORMATION, ET
CETERA.
AND THERE ARE SOME INTERESTING
CHALLENGES THAT WE DON'T DO A
GOOD JOB OF PROVIDING RESULTS OR
INFORMATION TO PARTICIPANTS OR
COMMUNITIES AFTER STUDIES ARE
DONE.
SO THIS IS OUR FRAMEWORK AND
SYSTEMATIC AND SEQUENTIAL AND WE
ARGUE NECESSARY.
SOMETIMES THERE ARE WAIVERS OF
CERTAIN PROCEDURAL REQUIREMENTS
THAT ARE UNIVERSAL AND IT HAS TO
BE ADAPTED TO THE CONTEXT.
IT DOES REQUIRE BALANCING
SPECIFICATION AND JUDGMENT THAT
YOU WILL HEAR ABOUT THAT THRU
OUT THE COURSE.
WE NEED PEOPLE THAT ARE INFORMED
INVESTIGATORS AND IRB MEMBERS
AND OTHERS INTERESTED IN
RESEARCH TO BE ABLE TO
UNDERSTAND WHAT PRINCIPLES ARE
AND HOW TO APPLY THEM.
THAT IS THAT.
I JUST AM NOT EVEN ONE MINUTE
OVER. ALMOST.
>> PERFECTLY TIMED.
FIRST, DEEP APOLOGIES TO THOSE
OUT THERE LINKING TO THE VIDEO
CAST. WE HAD A PROBLEM WITH IT
EARLIER ON.
WE ARE NOW LIVE.
WILL YOU HAVE ACCESS TO THE
RECORDING OF THE FIRST PART OF
THE -- MY SESSION IN THE FIRST
PART OF CHRISTINE'S SESSION WHEN
WE POST IT ONLINE.
AND FOR THOSE OF YOU WHO ARE OUT
IN VIDEOCAST LAND, IF YOU HAVE
QUESTIONS FOR CHRISTINE OR SUSAN
OR ME LATER, THERE IS A
DISCUSSION BOARD THAT IS CALLED
SESSION 1 QUESTIONS.
FEEL FREE TO POST QUESTIONS
THERE.
SO WE HAVE LOTS OF PEOPLE IN THE
ROOM.
I'M HOPING SOME OF YOU HAVE SOME
QUESTIONS.
IF YOU DO HAVE A QUESTION,
THERE ARE TWO MICS HERE.
FEEL FREE TO GO TO EITHER ONE,
AV FOLKS WOULD LIKE TO HAVE YOU
RECORD IT.
IT LOOKS LIKE YOU HAVE A
QUESTION.
>> GOOD.
>> I WAS HOPING YOU COULD GIVE
ME EXAMPLES OF A SOCIAL VALUE
CLINICAL AND SCIENTIFIC VALUE
ARE FAIRLY EASY TO UNDERSTAND
AND VISUALIZE EVEN AND NOT
EXACTLY SURE HOW TO INTERPRET
SOCIAL VALUE.
>> SOCIAL VALUE, TWO WAYS TO
ANSWER YOUR QUESTION AND ONE IS
THAT IS RUBRIC UNDER WHICH WE
PUT ALL OF THAT. THERE IS SOME
OF THAT.
VALUABLE USEFUL CLINICALLY AND
SCIENTIFICALLY.
THERE COULD BE I HAVE TO THINK
OF AN EXPERIMENT OF STUDY THAT
HAD I DON'T KNOW. MAYBE CASH
TRANSFERS FOR CERTAIN VACCINE
UPTAKE OR SOMETHING LIKE THAT.
THAT IS HEALTH RELATED AND HAS
SOCIAL VALUE AS WELL AS PERHAPS
INDIVIDUAL VALUE FOR
PARTICIPANTS OR PEOPLE WHO -- IF
WE PROVE IT WORKS AND COMES TO
MIND.
>> YEAH.
>> THERE ARE OTHER EXAMPLES.
I'M BLINKING WHAT THEY MIGHT BE
AND IMPORTANT THING IS PEOPLE
THINK OF SOCIAL VALUE HAVING
CLINICAL RELEVANCE AND MY OWN
VIEW IS THAT IS TOO NARROW.
IF YOU THINK ABOUT FOR EXAMPLE
EARLY PHASE STUDIES AND EARLY
PHASE EXPERIMENTS, MAYBE THEY
WILL HAVE CLINICAL VALUE DOWN
THE ROAD AND WHAT THEY AT THE
TIME HAVE IS SCIENTIFIC VALUE
AND WE ARE LEARNING WHAT THIS
THING DOES AND HOW THIS THING OR
HOW SAFE IT IS AND WE CAN GO AND
TEST IT FOR CLINICAL VALUE.
>> GREAT. YOU WANT INTRODUCE
YOURSELF?
>> SURE. I'M CHARLENE AND
POSTBACK ERTA AND GREAT
INTRODUCTION DR. GRADY AND THANK
SO YOU MUCH.
I HAD A SIMILAR QUESTION ABOUT
THE JUSTIFICATIONS FOR RESEARCH
AND WHILE I CAN UNDERSTAND
REASONS WHY WE WANT SOCIAL VALUE
OR VALUE IN SOME SENSE FOR ANY
FORM OF RESEARCH AND I GUESS
ALSO WONDERING ABOUT ARGUMENTS
AGAINST IT AND WHAT TYPE OF
ARGUMENTS THEY LOOK LIKE AND IS
IT JUST INABILITY TO MEASURE
VALUE OR IS THERE SOMETHING
ELSE?
IS THERE ANY CASES THAT I COULD
THINK OF WHERE AT CONCEPTION
RESEARCH MIGHT NOT HAVE VALUE OR
PROJECTED VALUE AND ENDED UP
BEING VERY VALUABLE DOWN THE
LINE?
>> GREAT QUESTION.
WHERE THIS IDEA CAME FROM IS A
SCHOLAR WHO WROTE IN THE 1980S
AND NAMED BENJAMIN FRIEDMAN AND
HE WROTE A PAPER ONE TIME CALLED
SOCIAL VALUE.
BASICALLY HE DESCRIBED IN THE
PAPER THAT HE HAD WHAT HE CALLED
A NIGHTMARE WALKING DOWN THE
HALL AND NIGHTMARE AND FRIEND
CAME UP TO HIM AND SAID I
SUCCESSFULLY TRANSPLANTED AN
APPENDIX AND IN THE ARTICLE BEN
GEE SAYS AND SCRATCHED HEAD AND
SAID IS THAT ETHICAL AND FRIEND
SAID I GOT THE GUY'S INFORMED
CONSENT AND QUESTION WAS WHAT IS
YOUTHFULNESS OF UNDERSTANDING
TRANSPLANTATION OF APPENDIX? IS
THERE ANYTHING WE CAN LEARN FROM
THAT OR REASON TRANSPLANTING
APPENDIX WOULD OR COULD BE A
GOOD THING AND USING IT
CLINICALLY OR SCIENTIFICALLY OR
SOCIALLY?
WHAT IS THE POINT?
SO THAT IS A EXAMPLE.
I THINK AT THE SAME TIME YOU
MIGHT IMAGINE THAT AT A
DIFFERENT POINT IN TIME AND
DON'T KNOW THAT -- I CAN'T COME
UP WITH A SCIENTIFIC EXPLANATION
BUT MAYBE THERE IS A SCIENTIFIC
REASON TO TRANSPLANT AN
APPENDIX, FOR EXAMPLE.
IF THERE IS, WE COULD LEARN
SOMETHING VALUABLE THAT MIGHT
HELP TO UNDERSTAND OR PROMOTE
HUMAN HEALTH AND MAYBE IT WOULD
BECOME SOCIALLY VALUABLE AND
QUESTION TO START WITH IS WHAT
IS THE REASON OR WHAT IS THE SO
WHAT OF DOING THIS STUDY?
WHAT WILL WE -- WHY ARE WE DOING
IT AND WHAT WILL WE LEARN FROM
IT?
THAT IS THE MOTIVATION BEHIND
SOCIAL VALUE AND THERE ARE
EXAMPLES OF STUDIES THAT HAVE
BEEN DONE AND PEOPLE SAY WHY DID
ANYONE EVER DO THAT?
WE DIDN'T -- YOU KNOW, WHAT IS
USEFULNESS OF THAT QUESTION?
THERE HAVE BEEN CERTAINLY
STUDIES THAT HAVE COME OUT MORE
POSITIVELY VALUABLE THAN WERE
PREDICTED AT THE TIME.
DOES THAT ANSWER YOUR QUESTION?
SORT OF?
>> GO AHEAD.
>> I'M JONATHAN.
>> I KNOW.
>> GOOD TO SEE YOU AGAIN.
I WAS WONDERING IF YOU COULD
TALK A LITTLE ABOUT THE
METHODOLOGIES THAT WERE USED IN
LIKE THE BELMONT REPORT OR THE
HELSINKI OR WHAT WAS IT?
HELSINKI -- DECLARATION OF
HELSINKI WAS IT AN
INTERDISCIPLINARY BACKGROUND AND
PEOPLE BRINGING THESE THINGS
SETTLING THEM OR WHAT DO THEY DO
EXACTLY.
>> GREAT QUESTION AND WHAT I
KNOW AND PROBABLY NOT ANYTHING
AND BELMONT REPORT WRITTEN BY
NATIONAL COMMISSION THAT IS ONE
OF THE FIRST IN THE UNITED
STATES THAT FOCUSED ON ETHICS AT
ALL AND WAS CERTAINLY FOCUSED ON
PROTECTION OF HUMAN SUBJECTS.
STAFF WROTE THE BELMONT REPORT.
WITH DOCUMENTS, I -- YOU CAN
FIND THEM, HISTORICAL VERSIONS
OF THEM.
BOB LEVINE WAS AN EDGE CYST OR
PHYSICIAN EDGE SIFT AT YALE
DOING WORK IN ESTABLISHMENT OF
ETHICS IN CLINICAL RESEARCH AND
HE WROTE BACKGROUND PAPER GIVEN
TO THE STAFF THAT STAFF INCLUDED
PEOPLE LIKE TOM BEACHUM
PHILOSOPHER AT GEORGETOWN AND
FAMOUS FOR FOUR PRINCIPLES
GEORGETOWN MANTRA OF BIOETHICS
AND HOPEFULLY I DON'T SAY THINGS
THAT YOU DON'T KNOW WHAT I'M
TALKING ABOUT.
PEOPLE ASKED TO SUPPLY THEM AND
EXPERTISE OF THE PEOPLE IN THE
ROOM AND STAFF AND THEN IT HAD
TO BE APPROVED BY THE COMMISSION
AND THERE -- THAT SORT OF
MULTI-DISCIPLINARY EFFORT THERE
AND DECLARATION OF HELSINKI IS
DIFFERENT.
IN EACH OF THE DOMESTIC MEDICAL
ASSOCIATIONS WE HAVE AMERICAN
MEDICAL ASSOCIATION AND
ASSOCIATIONS LIKE THAT IN MANY
COUNTRIES IN THE WORLD AND
MEDICAL WORLD ASSOCIATION IS
COLLABORATION OF ALL OF THOSE
AND MOST PEOPLE THAT WOULD BE
AROUND THE TABLE DECIDING ARE
PHYSICIANS THAT RUN THEIR
MEDICAL ASSOCIATION IN THEIR
COUNTRY AND AT LEAST IN THE LAST
SEVERAL ITERATIONS OF
DECLARATION OF HELSINKI HAD
CONSULTANCIES I MENTIONED THEY
HAD NOW AND BRING IN PEOPLE AND
INVITE PEOPLE TO COME AND GIVE
THEM, YOU KNOW, TALKS AND
INFORMATION AND BACKGROUND
MATERIALS ABOUT SPECIFIC ISSUES
AND YOU DELIBERATE ABOUT THOSE.
>> QUICK SIDEBAR, THE
TRANSCRIPTS OF EVERYTHING THAT
THE NATIONAL COMMISSION DID ARE
IN A ROOM AT GEORGETOWN AND I
VISITED IT MANY YEARS AGO.
>> YEAH.
>> YOU HAVE TO BE MONITORED.
FACULTY -- A MEMBER OF THE
LIBRARY STAFF HAD TO SIT THERE
WITH ME TO MAKE SURE I DIDN'T
RUN OFF WITH ANYTHING.
IF YOU ARE INTERESTED IN,
JONATHAN, THERE IS A PLETHORA OF
PAPER TO REVIEW AND WHOLE SET
FOR THOSE INTERESTED FOR EACH
REPORT THAT THE COMMISSION WROTE
INCLUDING BELMONT REPORT AND ONE
ON IRBS AND PSYCHOSURGERY AND
ARE BOUND COPIES OF REPORTS THAT
THEN -- BELMONT REPORT AND THESE
THAT LED TO ADDITIONAL AND ONES
ON KIDS AND ADDITIONAL
REGULATIONS ON OUR SHELF IN THE
LIBRARY.
>> WE HAVE LOTS IN THE
DEPARTMENT.
>> IF NOT THERE IN NIH LIBRARY.
THANK YOU, AGAIN CHRISTINE.
>> GO AHEAD.
>> WE ARE IN A HIGHLY REGULATORY
STATE FOR RESEARCH NOW.
WE DO SCIENTIFIC REVIEW
COMMITTEES BEFORE WE GET THEM
AND SUBMIT TO THE IRB AND SINCE
COMMON RULINCEPTION 20 YEARS AGO
AND THESE OTHER WONDERFUL CODES
AND REGULATORY PROCEDURES WE
HAVE NOW IS THERE SOME WAY THEY
ARE TRACKING IF THE IMPACT LIKE
ARE WE --
>> YEAH.
>> WE ARE DOING BETTER RESEARCH
I KNOW AND NOW YOU READ ABOUT AI
BEING USED AND PEOPLE PUBLISHING
FALSE DATA AND IS THERE
REGULATORY OR SOME PLACE WE CAN
GO SEE HOW WE ARE DOING?
WE ARE I THINK DOING WELL BUT
DON'T KNOW AND WILL WE COVER
THAT IN THE COURSE OR.
>> GREAT QUESTION.
SAD ANSWER IS THERE IS NO
COMPREHENSIVE SUMMARY HOW WE
HAVE BEEN DOING.
>> RIGHT.
>> THERE ARE PIECES OF EVIDENCE
ABOUT HOW WE HAVE BEEN DOING.
>> I THINK SO.
>> YEAH.
>> I THINK MAYBE HOLLY WILL TALK
ABOUT IT WITH SPECIFIC REFERENCE
TO HOW IRBS ARE DOING.
>> YEAH.
>> YEAH. SO EXACTLY.
THERE ARE -- YOU KNOW, INFORMED
CONCEPT IS A GOOD EXAMPLE HOW WE
HAVE NOT MADE A LOT OF PROGRESS
AND WE HAVE DONE LOTS OF
EMPIRICAL WORK TO IMPROVE
PROCESS AND SHORTENED FORMS, ET
CETERA.
FORMS ARE STILL LONG.
THERE ARE SPACES AMONG MANY
TOPICS DISCUSSED THAT THERE IS A
BIT OF EVIDENCE THAT THINGS HAVE
GOTTEN BETTER AND WE WILL TALK
ABOUT A COUPLE OF THOSE DURING
THE COURSE.
>> YEAH.
>> THANK YOU VERY MUCH.
>> THANK YOU.
>> IF FOLKS HAVE QUESTIONS THAT
COME TO YOU AFTERWARDS, FEEL
FREE TO GO TO THE DISCUSSION
BOARD IN CANVAS AND WRITE THEM
DOWN.
I WILL ANSWER THOSE AT -- YOU
KNOW, I WILL BE ANSWERING THEM,
PERIOD.
GREAT.
ANOTHER THING I DIDN'T MENTION
WHEN WE STARTED IS WE ALWAYS
HAVE A 15 MINUTE BREAK AFTER DR.
LEDDERER'S LECTURE WE WILL HAVE
A 15 MINUTE BREAK AND THOSE
WATCHING BY VIDEO, GRAB A CUP OF
COFFEE AND THOSE THAT ARE HERE
DO THE SAME.
WITHOUT FURTHER ADO, I WILL
INTRODUCE OUR FIRST GUEST
LECTURER, SUSAN LEDERER IS
RONALD L NUMBERS PROFESSOR OF
MEDICAL HISTORY AND BIOETHICS
UNIVERSITY OF WISCONSIN SCHOOL
OF MEDICINE AND PUBLIC HEALTH
AND HISTORIAN OF 19TH AND 20TH
CENTURY AMERICAN MEDICINE IN
PUBLIC HEAL MG AND PUBLISHED A
BOOK THAT MADE ME THE PERSON I
AM AND SPEND MOST MOST OF MY
TIME DOG RESEARCHICS ETHICS.
I READ HER BOOK BEFORE THE
SECOND WORLD WAR AND FEEL FREE
IF YOU WANT CITATIONS FOR THAT
AND WITHOUT FURTHER ADO, I WILL
HAND IT TO DR. LEDERER.
>> THANK YOU. CAN YOU HEAR ME?
>> WE CAN. WE CAN'T SEE YOU GET
BUT DEFINITELY HEAR YOU. FEEL
FREE TO START.
>> OKAY. YOU WILL PUT MY SLIDES
UP?
>> YES. I WILL MOVE YOUR SLIDES
FORWARD.
LET ME KNOW WHEN.
>> ALL RIGHT. COULD YOU SHOW
THE NEXT SLIDE.
>> YUP. I'M ON YOUR DISCLOSURE.
>> MY DISCLOSURE SLIDE.
THEN THE NEXT SLIDE.
OKAY. WHAT I WILL TALK ABOUT
THIS MORNING IS WHAT I WILL CALL
A SCANDALISHLY SHORT HISTORY OF
RESEARCH ETHICS AND SO MUCH MORE
I COULD SAY AND HOPEFULLY WHAT I
SPEAK TO YOU ABOUT THIS MORNING
WILL GIVE YOU SOME APPRECIATION
OF THE ROLE OF THE PAST IN
SHAPING RULES FOR RESEARCH THAT
GOVERNED USE OF HUMAN SUBJECTS
IN RESEARCH, YOU KNOW, FOR
DECADES AND DR. GRADY SO
ELOQUENTLY DESCRIBED, REQUIRE
VIGILANCE BECAUSE RESEARCH
CHANGES AND SOCIETY CHANGES AND
IT IS IMPORTANT TO KEEP FACT
THAT THESE ARE CHANGEABLE IN
MIND.
SO WHAT I WANT TO FOCUS ON TODAY
IS WHY WE HAVE PARTICULAR KINDS
OF RULES WE HAD AND THE ROLE OF
SCANDALS AND TRAGEDIES AND
REVELATIONS OF ABUSES.
SHAPED THE PARTICULAR
REGULATIONS.
AND I WANT TO ALSO MAKE A
BROADER HISTTO R KALELE POINT
THAT US POLICY -- HEALTH POLICY
IN GENERAL OVER THE COURSE OF
THE 20TH CENTURY WAS ALSO
RESPONSIVE TO SCANDAL AND
TRAGEDY AND WILL GO THROUGH VERY
BRIEFLY A SERIES OF -- OF
EXAMPLES TO HELP PUT THIS IN
MIND.
THE NEXT SLIDE.
SOME OF YOU MAY KNOW THAT THE
FIRST FOOD AND DRUG REGULATION
OCCURRED IN 1906 AND WERE
CONCERNS ABOUT THE SAFETY OF
PATENT MEDICINES, FOR EXAMPLE.
LACK OF SAFETY AND SEE COCAINE
TOOTH DROPS AND IT ACTUALLY
CONTAINS COCAINE IN SMALL DOSES
AND REALLY WAS NEXT SLIDE, THE
CONCERN OVER THE SAFETY OF THE
FOOD SUPPLY AND SOME MIGHT HAVE
READ UPTON SINCLAIR'S -- THE
JUNGLE AND AS HE FAMOUSLY SAID
HE AIMED FOR THE NATION'S HEART
AND REACHED THE STOMACH THAT
PUSHED US CONGRESS IN 1906 AND
NEXT SLIDE TO PASS THE FOOD AND
DRUG ACT IN 1906 WHICH WAS THE
FIRST SORT OF REGULATORY VENTURE
TO ENSURE THE SAFETY OF FOOD AND
DRUGS USED BY AMERICAN CONSUMERS
AND NEXT SLIDE.
MAJOR REVISION OF FOOD AND DRUG
ACT OCCURRED IN 1938 FOLLOWING
TERRIBLE TRAGEDY IN WHICH A
CHEMIST USED AS A SOLVENT FOR
NEW DRUGS DIE ETHYLENE GLYCOL
USED IN ANTIFREEZE USED IN
DEATHS OF MORE THAN 1 HUNDRED
CHILDREN
NEXT SLIDE.
I'M SORRY.
OKAY. AGAIN, LED TO TRAGIC
DEATHS AND THERE WAS NOTHING
THAT THE FOOD AND DRUG
ADMINISTRATION COULD ACTUALLY DO
TO PULL DRUGS OFF THE MARKET.
NEXT SLIDE.
THERE WERE ALSO CONCERNS ABOUT
THE SAFETY OF COSMETICS AND MAS
CARE AH THAT WOULD BLIND WOMEN
AND REDUCING DRUGS THAT WOULD
MAKE YOU LOSE WEIGHT AND ALSO
KILL YOU.
NEXT SLIDE.
IT LED TO THE FIRST SORT OF
MAJOR REVISIONS OF THE FOOD AND
DRUG AND COSMETIC ACT FOR THE
FIRST TIME.
FOR THE FIRST TIME.
THAT DRUGS AND COSMETICS
ACTUALLY HAD TO BE TESTED FOR
TOXICITY BEFORE MARKETING AND
HAD TO BE DIRECTIONS ON THE
PACKAGE AND THAT SOME DRUGS WERE
TOO DANGEROUS TO BE DISPENSED
JUST OVER THE COUNTER AND HAD TO
BE DISPENSED BY PRESCRIPTION
ON
ONLY.
NEXT SLIDE IN 1960S, REVELATION
OF PLETHORA OF CHILDREN BORN
WITH UNUSUAL BIRTH DEFECTS
EVENTUALLY CONNECTED TO PRENATAL
USE OF THAL IDOMIDE NEXT SLIDE
LEADING TO AMENDMENTS OF FOOD
AND DRUG ACT IN [INDISCERNIBLE]
HARRIS AMENDMENTS FDA FOR FIRST
TIME COULD DEMAND SCIENTIFIC
DATA TO DETERMINE THAT THE DRUG
WORKED.
NEXT SLIDE.
IN A VERY DIFFERENT REALM,
TALKING ABOUT THE REGULATION OF
ANIMAL EXPERIMENTATION, FOR
SOMETHING -- SORRY.
NEXT SLIDE.
OKAY. IN A VERY DIFFERENT
REALM, FOR SOMETHING LIKE SEVEN
DECADES, CONGRESS HAD BEEN
REVISITING POTENTIAL LEGISLATION
TO PROTECT ANIMALS USED IN
RESEARCH AND AFTER THIS PHOTO
ESSAY THAT APPEARED IN LIFE
MAGAZINE IN 1966, NEXT SLIDE.
CONGRESS RECEIVED MORE MAIL
ABOUT THIS, YOU KNOW, THEFT OF
DOGS AND ORGANIZED PET THEFT AND
TREATMENT OF ANIMALS BEFORE
GETTING TO THE LABORATORY AND
CONGRESS GOT MORE MAIL THAN THEY
DID ABOUT THE VIETNAM WAR AND
PASSED ANIMAL WELFARE ACT AND
LIKE NATIONAL RESEARCH ACT HAS
BEEN AMENDED OVER YEARS AS
ANIMAL EXPERIMENTATION ITSELF
ALSO CHANGED AND NEXT SLIDE THE
NATIONAL RESEARCH ACT THAT WE
WILL TALK ABOUT TODAY THAT WAS
SHAPED BY REVELATIONS
PARTICULARLY IN 1960S OF ABUSES
OF HUMAN SUBJECTS IN AMERICAN
MEDICAL RESEARCH.
NEXT SLIDE.
EVEN BEFORE THE TUSKEGEE
SYPHILIS STUDY TIPPING POINT FOR
CONGRESS TO PASS THERE WERE NAZI
MEDICAL EXPERIMENTS AND
EXPERIMENTATION IN THE UNITED
STATES.
BOTH OF THE HISTORY OF HUMAN
EXPERIMENTATION AROUND HISTORY
OF CONTROVERSY AND CONCERN ABOUT
MORAL PROBLEMS RAISED BY HUMAN
EXPERIMENTATION ARE OLDER AND
WILL GIVE A BRIEF EXAMPLE.
NEXT SLIDE.
AS EARLY AS -- OKAY. NEXT
SLIDE.
IN 19 HUNDRED, UNITED STATES
CONGRESS ACTUALLY ENTERTAINED OR
LEGISLATION THAT WOULD HAVE A
SENATE BILL OF 3424 REGULARING
HUMAN EXPERIMENTATION IN
DISTRICT OF COLUMBIA AND 19
HUNDRED WOULD HAVE REQUIRED
INVESTIGATORS TO DISCLOSE IN
ADVANCE PURPOSE AND PROCEDURES
OF NONTHERAPEUTIC EXPERIMENTS
INVOLVING HUMAN BEINGS AND NEXT
SLIDE.
IT ALSO CALLED FOR AN EXPLICIT
BAN ON USING PEOPLE IN STUDIES
AND PEOPLE DEEMED UNABLE TO --
UNABLE TO CONSENT TO
PARTICIPATION.
THIS INCLUDED CHILDREN UNDER THE
AGE OF 21 AND INFANTS AND
PREGNANT WOMEN WHO WERE DEEMED
UNABLE TO EXERCISE SORT OF ADULT
DECISION MAKING CAPACITY.
THAT IS ANOTHER STORY.
SO THESE BILLS DID NOT PASS.
BUT IT IS -- IT EXHIBITS A
CONCERN THAT PEOPLE HAD ABOUT
DIRECTION IN WHICH MEDICAL
RESEARCH WAS DEVELOPING AND
DON'T WANT TO GIVE YOU IDEA THAT
RESPONSIBLE MEDICAL
EXPERIMENTATION WAS IN FACT NOT
OCCURRING AT THIS TIME.
ONE OF THE BEST EXAMPLES OF THIS
IS THE NEXT SLIDE.
IT IS THE EXPERIMENTS CONDUCTED
UNDER THEOS PISSES OF THE U.S.
ARMY AND YELLOW FEVER BOARD
EXPERIMENTS IN CUBA IN 19
HUNDRED AND 1901 AND SOME MAY
KNOW NAME OF WALTER REED WHO LED
A COMMISSION.
THEY WERE INTERESTED IN
ESTABLISHING HOW YELLOW FEVER
SPREAD AND WAS A REAL THREAT IN
THE SOUTHERN UNITED STATES AND
CENTRAL AMERICA AND SOUTH
AMERICA IN THIS TIME PERIOD.
THEY WERE DETERMINED TO
ESTABLISH THE VECTOR OF YELLOW
FEVER THAT THEY EVENTUALLY DID
AND FOR THAT RESEARCH HAD TO
EXPOSE HUMAN BEINGS TO
CONSIDERABLE RISK AND NEXT
SLIDE.
THEY NEEDED -- THEY NEEDED
PEOPLE THAT WERE NEW TO THE
ISLAND AND MANY OF THE PEOPLE
WERE NEWLY ARRIVED SPANISH
PEOPLE AND THEY NEEDED NAÏVE
SUBJECTS TO SEE IF THEY COULD
SPREAD DISEASE THROUGH VARIOUS
MEANS INCLUDING MOSQUITOS AND
REINTRODUCED A WRITTEN
PERMISSION FORM AVAILABLE IN
ENGLISH AND SPANISH AND IT, YOU
KNOW, IT DID NOT OR WOULDN'T
MEET STANDARDS OF INFORMED
CONSENT AND WAS EXTRAORDINARY OF
ITS TIME WARNING DANGER TO LIFE
AND EXPERIMENTS AND EFFECTIVE
CLOTHING AND MOSQUITOS AND
PROMISED GOOD MEDICAL CARE AND
IDENTIFIED CONSIDERABLE
COMPENSATION MEN WOULD RECEIVE
IF THEY SIGNED AND WERE SELECTED
FOR THE STUDY.
NEXT SLIDE.
SUBJECTS WHO WERE SELECTED
RECEIVED 1 HUNDRED DOLLARS IN
AMERICAN GOLD A CONSIDERABLE SUM
AT THE TIME AND PROMISED TO GIVE
2 HUNDRED DOLLARS TO SURVIVING
FAMILY IF DEATH OCCURS AND
FRANKFORTNATELY NO PARTICIPANTS
IN STUDY DIED AND INVESTIGATORS
SUCK COUPLED TO YELLOW FEVER
DURING THE COURSE OF THE STUDY
AND NEXT SLIDE AND BEGINNING
WITH SHIFT TO WWII REPRESENTING
AN IMPORTANT MOMENT IN HISTORY
OF RESEARCH IN THE UNITED STATES
AND IN ETHICS AND 1941 PRESIDENT
ROOSEVELT'S OFFICE FOR
SCIENTIFIC RESEARCH WAS
ESTABLISHED AND IMPORTANTLY FOR
MEDICAL RESEARCH WAS ADVENT OF
UNPRECEDENTED FEDERAL FUNDING
FOR MEDICAL RESEARCH THAT WAS
RELATED TO THE WAR EFFORT THAT
SOMETHING SMA WOULD CONTINUE
AFTER THE WAR AND IMPORTANT
MOMENT IN THE GROWING
RECOGNITION IN IMPORTANCE OF
MEDICAL RESEARCH NOT ONLY TO US
SOCIETY AND TO OUR PLACE IN THE
WORLD AS WELL.
NEXT SLIDE.
NOW, I ALSO MENTIONED IF YOU
WILL NAZI MEDICAL
EXPERIMENTATION AND AGAIN AS IN
THE UNITED STATES HIGH RANKING
NAZI OFFICIALS BELIEVED THAT
MEDICAL RESEARCH WOULD HELP
GERMANY WIN THE WAR AND
UNDERTOOK AMBITIOUS AND
FRIGHTENING PROGRAM OF RESEARCH
TO ADVANCE MEDICAL INTERESTS AND
SOME MIGHT BE FAMILIAR YOU TO.
IT IS USEFUL TO BRIEFLY REVISIT
THEM AND IF YOU COULD GO TO THE
NEXT SLIDE AND AMONG FIRST THAT
WERE UNDERTAKEN WERE THOSE AT
DACA CONCENTRATION CAMP EFFECTS
OF EMERSION OF FREEZING WATER
AND ENDED WITH DEATH OF THE
PARTICIPANT SORT OF HOW LONG IT
WOULD TAKE TO DIE IF IN FREEZING
WATER AND WOULD EQUIPMENT FOR
EXAMPLE HELP YOU TO SURVIVE
LONGER SO YOU MIGHT BE RESCUED
AND SO FORTH.
NEXT SLIDE.
ALSO AT DACAU CONCENTRATION CAMP
AND STUDIES AND ECHLTHS OF HIGH
ALTITUDE AND LOW OXYGEN
CONCENTRATION AND IT WAS
IMPORTANT BECAUSE THEY WANTED TO
STUDY POST MORTEM CHANGES IN THE
BRAIN.
NEXT SLIDE.
AS IN THE UNITED STATES, NAZIS
WERE INTERESTED IN SEA WATER
STUDIES AND HOW TO QUICKLY
DESALINATE SEE WATER TO PROMOTE
SURVIVAL AT SEA SO FLYERS FOR
EXAMPLE COULD BE RESCUED OR NAVY
PERSONNEL AND YOU SEE HERE A
VICTIM OFA VICTIM OF NAZI
MEDICAL EXPERIMENTS INVOLVING
AMONG OTHER THINGS, YOU KNOW,
GIVING PEOPLE TO SEE HOW LONG
YOU WOULD SURVIVE WITH
ABSOLUTELY NO WATER AND FORCING
SEA WATER ON PEOPLE AND GIVING
SEA WATER FLAVORED WITH TOMATO
EXTRACT AND INVOLVING GREAT
SUFFERING IF NOT DEATH TO THE
PARTICIPANTS AND NEXT SLIDE.
SO THE STUDY OF BIRDS AND WOUNDS
WAS ALSO OF GREAT INTEREST IN
THE UNITED STATES AND STANDARD
BURDEN AND WOUND DEVELOPED ON
ANIMAL SUBJECTS CHIEF PIGS AND
DOGS AND POLISH WOMEN AT
CONCENTRATION CAMP AND
DELIBERATELY INFECT OR CUT OPEN
TO CREATE A WOUND AND INFECTED
WITH BACTERIA DIRT SLIVERS OF
GLASS TO STUDY NATURAL HISTORY
OF THE WOUND AND VARIOUS WAYS TO
PROMOTE HEALING.
NEXT SLIDE.
OKAY.
AFTER THE WAR, AFTER THE TRIALS
OF THE MAJOR NAZI WAR CRIMINALS,
U.S. MILITARY TRIBUNAL TOOK ON
VARIOUS GROUPS AND FIRST
PROSECUTION OF VARIOUS GROUPS
FOR WAR CRIMES.
FIRST GROUP WAS NAZI DOCTORS
AND IN 1946, TRIAL OF THE UNITED
STATES VERSUS KARL BRANT ET AL
BEGAN AND NEXT SLIDE, ACTION
BROUGHT AGAINST 23 HIGH-RANKING
NAZI MEDICAL PERSONNEL AND 22
MEN AND ONE WOMAN AND WOMAN
DOCTOR PRESIDING OVER SOME BURN
AND WOUND STUDIES AT ROBIN'S
BROOK.
THERE IS MUCH THAT COULD BE SAID
AND ENTIRE BOOKS WRITTEN ABOUT
NAZI DOCTORS TRIAL AND WHAT I
WILL SAY HERE IS NEXT SLIDE.
THAT WHAT AMONG ISSUES FOR
TRIBUNAL WAS HOW TO JUDGE THESE.
WERE THESE NORMAL MEDICAL
RESEARCH OR WERE THERE RULES
ABOUT RESEARCH AND HOW TO ASSESS
GUILT OR INNOCENCE OF THE NAZI
DOCTORS ON TRIAL.
AND IN SO DOING, THEY ACTUALLY
FORMULATED A LIST OF PRINCIPLES
THAT CONSTITUTED PERMISSIBLE OR
ACCEPTABLE HUMAN
EXPERIMENTATION.
NEXT SLIDE.
I WILL SAY THAT THERE WAS SOME
SQUIRMING ON THE PART OF SOME OF
THE AMERICAN DOCTORS THAT WERE
CALLED IN TO ADVISE ABOUT THE
TRIAL.
THE DEFENSE ATTORNEYS
REPRESENTING KARL BRANT, FOR
EXAMPLE, SORT OF MADE A
COMPARISON AND WHAT IS DIFFERENT
WITH NAZI CONCENTRATION CAMP
EXPERIMENTS INVOLVING PRISONERS
AND KINDS OF EXPERIMENTS BEING
CONDUCTED IN AMERICAN PRISONS AT
THE SAME TIME AND EXPERIMENTS
THAT INVOLVED DELIBERATE
INFECTION WITH DISEASE AND
EXPERIMENTS IN WHICH SOMETIMES
PRISONERS IN FACT DIED.
NEXT SLIDE.
ONE OF THE THINGS THAT WAS
ACTUALLY BROUGHT INTO EVIDENCE
BY NAZI OR GERMAN DEFENSE
ATTORNEY WAS AN ISSUE OF LIFE
MAGAZINE FROM JUNE 4TH 1945
FEATURING MALARIA RESEARCH AT
STATEVILLE PRISON IN ILLINOIS
WHERE SOME 40 OR 50 INMATES
ACTUALLY UNDERWENT INFECTION
WITH LOADED MOSQUITOS IN ORDER
TO STUDY MALARIA AND ITS
TREATMENT AND NEXT SLIDE.
AS I ALREADY MENTIONED, WHEN
THEY DELIVERED THEIR VERDICT IN
NAZI DOCTOR'S TRIAL, THEY --
JUDGES WITH ADVICE OF SEVERAL
PHYSICIANS PUT TOGETHER A SET OF
10 PRINCIPLES, CALLED
PERMISSIBLE MEDICAL EXPERIMENTS
WE HAVE COME TO KNOW AND
UNIVERSALLY IS CALLED NUREMBERG
CODE AND SEE IT ON YOUR READINGS
AND DISCUSSIONS USUALLY ABOUT
NUREMBERG CODE FIRST PRINCIPLE
GETS ATTENTION AND DESERVEDLY SO
AND SETS EXTRAORDINARILY HIGH
STANDARD THAT VOLUNTARY CONSENT
OF HUMAN SUBJECT IS ABSOLUTELY
ESSENT
ESSENTIAL.
IT DOESN'T PERMIT PROXY CONSENT
AND FOR EXAMPLE CHILDREN ARE NOT
LEGITIMATE SUBJECTS ACCORDING TO
NUREMBERG CODE AND EXCLUDES
OFTEN PEOPLE IN INSTITUTIONS AND
SO FORTH DEPENDING ON ONE'S
INTERPRETATION.
NEXT SLIDE.
THERE WERE, OF COURSE, OTHERS.
I WON'T GO THROUGH THEM.
JUST SOME THAT WERE SEEN AS
EXTREMELY IMPORTANT TO AMERICAN
PHYSICIANS WHO WANTED TO DEFEND
MEDICAL RESEARCH AND THAT
RESEARCH HAD TO BE BASED ON
PRIOR ANIMAL STUDIES AND IT WAS
INTENDED AT OUTSET TO AVOID
UNNECESSARY SUFFERING AND
SHOULDN'T HAVE DEATH AS ENDPOINT
STUDIES AND RISK SHOULDN'T
EXCEED BENEFIT AND
SCIENTIFICALLY ONLY QUALIFIED
PERSONNEL WERE TO CONDUCT
STUDIES AND NEXT IN CASE YOU ARE
INTERESTED I WILL TELL THAW 7 OF
THE NAZI DOCTORS WERE ACQUITTED
ON INSUFFICIENT EVIDENCE AND
SEVEN RECEIVED DEATH SENTENCES 9
RECEIVING PRISON SENTENCES
RANGING FROM 10 YEARS TO LIFE
IMPRISONMENT AND SURPRISING TO
ME THAT ALMOST ALL NINE WHO
RECEIVE PRISON SENTENCES HAD
SENTENCES SERIOUSLY COMMUTED TO
ONE YEAR OR ONLY A FEW YEARS AND
BACK IN MEDICAL PRACTICE IN FACT
IN GERMANY.
KARL BRANT WAS AMONG THOSE
SENTENCED TO DEATH AND OFFERED
HIS BODY TO EXPERIMENTATION TO
THE U.S. ARMY THAT REJECTED HIS
OFFER AND HE WAS HANGED AT
LUNZBERG PRISON AND NEXT SLIDE
THERE IS DEBATE AMONG COLLEAGUES
AND RESEARCH IN HISTORY OF
ETHICS AND RESEARCH IN 1950S AND
60S AND 70S IN THE UNITED STATES
ABOUT WHAT NUREMBERG CODE
ACTUALLY MEANT TO MEDICAL
RESEARCHERS AND ARE ARGUMENTS
SORT OF ON BOTH SIDES.
SOME HAVE MADE CLAIM THAT
MEDICAL RESEARCHERS DIDN'T KNOW
NUREMBERG CODE EXISTED AND I
DON'T SUPPORT THIS AND 1953 FOR
EXAMPLE JOURNAL OF SCIENCE AND
SCIENTIFIC JOURNAL WITH LARGEST
CIRCULATION PUBLISHED CODE IN
BIG ARTICLE AND RESULTS OF
SYMPOSIUM DISCUSSING THIS AND
SEEMS TO ME THAT IS REACHING A
BROAD AUDIENCE.
AND I WILL ALSO SAY THAT IN
1953, THE SECRETARY OF DEFENSE,
CHARLIE WILSON, ACTUALLY SIGNED
A MEMORANDUM REQUIRING THE CODE
FOR ALL RESEARCH CONDUCTED BY
THE US ARMED FORCES.
AND CURIOUSLY AND PERHAPS
IRONICALLY, THE DOCUMENT WAS
ALSO CLASSIFIED AS TOP SECRET
AND SEEMS TO BE SOMETHING OF AN
IMPLEMENTATION FAILURE.
NONETHELESS, IT CAME TO THE
ATTENTION OF MANY PEOPLE.
NEXT SLIDE.
ON THE OTHER HAPPENED, A NUMBER
OF, YOU KNOW, COMMENTATORS HAVE
ARGUED THAT MOST AMERICAN
RESEARCHERS DISMISS THE
NUREMBERG CODE AS SOMETHING THAT
GERMANS AND BARR BARIAN NAZIS
WOULD NEED AND AMERICAN
RESEARCHERS DIDN'T NEED.
THEY WERE CAREFUL AND CONCERNED
ABOUT BOTH THE SAFETY AND
WELFARE OF THEIR SUBJECTS.
NEXT SLIDE.
I THIS I -- I THINK IT IS
IMPORTANT TO KEEP IN MIND THOUGH
IF YOU WERE TO ASK IF AMERICAN
RESEARCHERS INVESTIGATORS MET
NUREMBERG CODE AND REQUIREMENTS
AND RESEARCH GOING ON DURING AND
AFTER THE WAR ABSOLUTELY NOT.
IT SET AN EXTRAORDINARILY HIGH
STANDARD.
NEXT SLIDE. I WANT TO SORT OF
MAKE THE POINT HERE IN 1950S
THERE WAS TREMENDOUS SOCIAL
SUPPORT FOR MEDICAL RESEARCH
ENTERPRISE AND GREAT ADMIRATION
FOR MEDICAL RESEARCHERS
THEMSELVES AND IN PART IT IS
BECAUSE MEDICAL RESEARCH AT THIS
TIME WAS ASSOCIATED WITH
VOLUNTEERS AND IT WAS A
VOLUNTARY ACTION.
THERE WAS ACTUALLY A SOCIETY
CREATED FOR BOTH THESE HUMAN
GUINEA PIGS IN WHICH THEY WERE
HONORED FOR WILLINGNESS TO RISK
WELFARE AND LIVES TO ADVANCE
MEDICAL RESEARCH.
THERE WAS ALSO A LONG TRADITION
OF SELF-EXPERIMENTATION THAT
MANY PEOPLE IN THE PUBLIC AND I
THINK SOME RESEARCHERS SAW IT AS
KIND OF THE GOLD STANDARD AND IF
INVESTIGATOR WILLING TO RISK HIS
OR HER OWN BODY, IT -- THEN, YOU
KNOW, THAT WAS A TEST HOW MUCH
THEY WERE INVESTED IN IT AND
TODAY, OF COURSE,
SELF-EXPERIMENTATION IS NOT
RECOMMENDED AND I'M SURE YOU
WILL HEAR MORE ABOUT THAT IN THE
REST OF THE COURSE.
I ALSO WILL SAY THAT 1950S,
THERE HAD BEEN SO MANY GREAT
ADVANCES IN MEDICINE ASSOCIATED
WITH WAR TIME EXPERIENCE AND
PRIMARILY WITH THINGS LIKE
ANTIBIOTICS AND IMPORTANCE OF
BLOOD TRANSFUSION AND PEOPLE
WERE CONFIDENT THAT ONLY GREAT
THINGS WERE ALSO TO COME.
IN PART IT IS IMPORTANT TO KEEP
IN MIND THE SOCIAL RESPONSE TO
RESEARCH AND RESEARCH TRAGEDY
THAT WAS VERY DIFFERENT THAN IT
WOULD BE ONLY A DECADE LATER AND
I HAVE ALWAYS BEEN SURPRISED
WHEN I FOUND THIS ARTICLE THAT
IS FOR THE NEW YORK TIMES AS YOU
CAN SEE IT IS REPORTING DEATH IN
RESEARCH OF 18 YEAR OLD FRESHMAN
AT SEATTLE UNIVERSITY THAT WAS
-- HE HAD VOLUNTEERED TO TAKE
PART IN A BLOOD SUBSTITUTE STUDY
AND DIED.
HIS FATHER WAS ASKED BY
REPORTERS WAS HE GOING TO SUE
UNIVERSITY OR SUE AUTHORITIES?
HIS FATHER SAID, OF COURSE NOT.
THIS WAS A PROJECT THAT WAS
INTENDED TO ADVANCE MEDICAL
KNOWLEDGE AND HE WAS GOING TO
TREASURE HIS SON'S, YOU KNOW,
HEROIC PARTICIPATION IN SUCH A
STUDY AND IMAGINE IT COULD BE A
VERY DIFFERENT RESPONSE TODAY IF
A FRESHMAN DIED IN A RESEARCH
PROJECT.
NEXT SLIDE.
THAT MAY ALSO EXPLAIN
WILLINGNESS TO HAVE LARGE
NUMBERS OF CHILDREN PARTICIPATE
IN TRIALS OF THE NEW POLIO
VACCINE IN 1954.
I WILL REMIND YOU THAT POLIO
REVERSED THE USUAL TREND OF
INFECTIOUS DISEASE DEATH IN 19TH
AND 20TH CENTURY AND EPIDEMIC
POLIO GOT WORSE TERRIFIED
AMERICAN PARENTS AND CHILDREN
AND 1952 WAS WORST POLIO
EPIDEMIC ON RECORD AND TWO YEARS
LATER JONAS SAL K DEVELOPED WITH
FUNDING FROM NATIONAL FOUNDATION
FOR INFITILE PARALYSIS AND A
VACCINE AND 2000 AMERICAN
CHILDREN PARTICIPATED IN TRIALS
OF THE VACCINE AND YOU SEE A
PICTURE OF THOSE POLIO PIONEERS.
NEXT SLIDE.
HERE YOU SEE IT IS NOT AN
INFORMED CONSENT FORM.
IT IS ACTUALLY A PARENTAL
REQUEST FORM FOR A CHILD TO
PARTICIPATE IN THIS
POLIOMYELITIS VACCINATION FIELD
TRIAL.
IT REPRESENTS A SORT OF EARLY
ATTEMPT TO AT LEAST IN SOME WAYS
NOT AS ADVANCED IN WALTER REED'S
EARLY 19 HUNDRED BUT EARLY
ATTEMPT TO INFORM AT LEAST THE
PARENT OF THE CHILD AND
CONDITIONS OF PARTICIPATION AND
RISKS INVOLVED AND OR THE PARENT
TO AUTHORIZE THEIR
PARTICIPATION.
OF COURSE IT LED TO SUCCESSFUL
DEMONSTRATION OF AN EFFECTIVE
AND MOSTLY SAFE VACCINE THAT --
THAT WAS RESPONSIBLE FOR THE
ERADICATION OF POLIO IN THE
UNITED STATES.
AGAIN, SORT OF SOON THE WORLD
AND AT LEAST THAT IS THE HOPE.
NEXT ONE.
NOW, FOR THE MEDICAL RESEARCH
COMMUNITY, WHO ARE NOT UNAWARE
OF SOME OF THE MORAL PROBLEMS OF
MEDICAL EXPERIMENTATION IN THIS
PERIOD.
THEY WERE CONCERNED THAT THE
NUREMBERG CODE REPRESENTED 2 --
IT WAS UNWORKABLE GUIDE FOR
THEIR MEDICAL RESEARCH AND WOULD
NOT ALLOW EXPERIMENTS ON
CHILDREN OR ALLOW EXPERIMENTS ON
PEOPLE THAT ARE INSTITUTIONIZED
AND DYING AND MENTALLY ILL.
THERE ARE EFFORTS I'M MOST
FAMILIAR WITH EFFORTS OF WORLD
MEDICAL ASSOCIATION THAT DR.
GRADY ALREADY REFERRED TO AND 10
YEAR EFFORT FROM 1954 TO 1964 TO
CREATE A WORKABLE CODE OF ETHICS
THAT, AGAIN, IS THE CHALLENGE
THAT IS A PERENNIAL ONE AND HOW
YOU PROTECT HUMAN SUBJECTS AND
AT SAME TIME ENABLE MEDICAL R-
HE SEARCH TO ADVANCE FROM WHICH
PRESUMABLY ALL WOULD BENEFIT.
SO IT WAS LARGELY THE COMMITTEE
ON ETHICS OF THE WMA AND ITS
AMERICAN REPRESENTATIVES AND
FRENCH REPRESENTATIVES AND
BRITISH REPRESENTATIVES WHO
STRUGGLED OVER WHAT WOULD BE AN
EFFECTIVE SET OF RECOMMENDATIONS
FOR CLINICAL RESEARCHERS.
NEXT SLIDE.
WELL THIS CULMINATED AND YOU
HEARD IN THE 1964 DECLARATION OF
HELSINKI IN WHICH POSITIONS FROM
ALL OVER THE WORLD UNANIMOUSLY
RECOMMENDED A NOT A CODE OF
ETHICS BUT RECOMMENDATIONS THAT
WERE GUIDING CLINICAL RESEARCH.
NEXT SLIDE.
THIS REFERS TO ORIGINAL
DECLARATION OF HELSINKI IN 1964.
YOU KNOW IT UNDERGONE
SIGNIFICANT REVISIONS AND
PERHAPS IS ONE UNDER HAPPENING
EVEN AS WE SPEAK AND WHAT
PERHAPS IS MOST IMPORTANT
DIFFERENCE FOR RESEARCHERS FROM
THE EARLY NUREMBERG CODE IS IT
PERMITTED PROXY CONSENT.
IT -- SO, FOR EXAMPLE, CHILDREN
COULD PARTICIPATE IN CHILDS IN A
NUMBER OF NEW VACCINES COMING
ONLINE THAT PRISONER POPULATIONS
COULD PARTICIPATE IN TRIALS OF
NEW DRUGS.
THERE IS AN EXPLOSION IN THE
NUMBER OF DRUGS THAT BECOME
AVAILABLE IN THE 1950S, 60S AND
70S AND WILL REMIND YOU PRISONER
EXPERIMENTATION WAS NOT
PERMITTED IN COUNTRIES LIKE THE
UK.
AND FRANCE AND IN THE UNITED
STATES EVERY MAJOR
PHARMACEUTICAL COMPANY HAD A
MAJOR PRISON WARD FACILITY FOR
TESTING NEW DRUGS AND OTHER
INTERVENTIONS.
NEXT SLIDE.
THIS IS JUST TO SHOW SORT OF,
AGAIN, SORT OF RESEARCH AND
RESEARCH ETHICS.
ARE, YOU KNOW, ARE NOT STAGNANT
AND CHANGE OVER TIME AND BOTH
WAY THAT RESEARCH IS CONDUCTED
AND HOW IT IS UNDERSTOOD AND
CONTEXT IN WHICH IT IS BEING
EXPERIENCED AS WELL AS SORT OF
CHALLENGES AND ETHICAL
CHALLENGES THAT CON FRONT US.
NEXT SLIDE.
SO THAT IS BEING DONE ON THE
INTERNATIONAL LEVEL.
BACK IN THE UNITED STATES, I --
I WANT TO RETURN NOW TO THE --
TO THE UNITED STATES AND ITS
RESPONSE TO SCANDAL AND TRAGEDY
AND WHAT WILL PRECIPITATE
NATIONAL RESEARCH ACT IN 1974.
NEXT SLIDE.
WELL, AS I HAVE ALREADY
INDICATED BY 1960S, THERE IS NO
LONGER SORT OF FAITH IN MEDICAL
RESEARCH ENTERPRISE AND IS A
TIME OF CHALLENGE TO ALL
INSTITUTIONS AND PHYSICIANS ARE
NO EXCEPTION AND TWO THINGS
LARGELY ARE RESPONSIBLE FOR
PROPELLING CONGRESS TO ACT IS
ONE IS RELEASE OF HENRY BEECHERS
BOMB SHELL ARTICLE IN NEW
ENGLAND JOURNAL OF MEDICINE AND
WHAT REPRESENTS TIPPING POINT
REVELATION IN 1972 OF 4 YEAR
STUDY OF UN -- CIVIL US -- HE WA
PROFESSOR OF A- NTHESIA RESEARCH
HARVARD MEDICAL SCHOOL AND WOULD
GO ON IN OTHER ARENAS AS
CONVENER AS HARVARD AD HOC
COMMITTEE ON BRAIN DEATH AND
NEXT SLIDE IN 1966 HE PUBLISHED
THIS ARTICLE THAT I ENCOURAGE
YOU TO READ AND IS VERY SHORT
THIS ARTICLE ETHICS IN CLINICAL
RESEARCH NEXT SLIDE, PLEASE
DISCUSSES WITHOUT NAMING NAMES
OR NAMING JOURNALS TALKED ABOUT
22 EXAMPLES WHAT HE CALLED
QUESTIONABLE RESEARCH PRACTICES
THAT WERE QUESTIONABLE IN THAT
THEY WERE IN SO FAR AS THEY WERE
BEING CONDUCTED WITHOUT CONCERN
FOR SAFETY AND WELFARE OF
PARTICIPANTS AND OVERRIDING
POINT THAT BEECHER WANTED TO
COMMUNICATE WAS THIS WASN'T SORT
OF FROM FRINGE OR RESEARCHERS
BUT PEOPLE AT VERY HEART OF THE
MEDICAL RESEARCH AT INPRIZES IN
US MAJOR RESEARCHERS AND MAJOR
INSTITUTIONS.
ANOTHER POINT THAT BEECHER
WANTED TO MAKE IS IT INVOLVED
POPULATIONS THAT WOULD MEET MOST
PEOPLES DEFINITIONS OF
VULNERABLE AND WHO WERE SUBLTS
MENTALLY EFFECTIVE CHILDREN TERM
USED AT TIME AND JUVENILE
DELINQUENTS ELDERLY SEENILE AND
DEMENTED SOLDIERS IN ARMED
FORCES CHARITY PATIENTS GROUP WE
DON'T OFTEN SEE ALCOHOLICS
CHILDREN AND NEWBORNS AND
PATIENT AS THE N ICHLT HIH CLIN
CENTER AND 2 OF 22 EXAMPLES
WOULD HAVE BEEN WELL-KNOWN TO
READERS OF NEW YORK TIMES AND
MAJOR NEWSPAPERS IN UNITED
STATES AND IN 2016 WASN'T
IDENTIFIED AS STUDIES OF
HEPATITIS WILL OE BROOK STATE
SCHOOL BUT NONETHELESS INVOLVED
THEM. WILL OE BROOK LARGE
UNDERFUNDED INSTITUTION ON
STATEN ISLAND INTENDED FOR
MENTALLY EFFECTED CHILDREN AND
TERRIBLE PLACE BY ALL -- BY ALL
OBSERVERS AT INSTITUTION
HEPATITIS WAS RIEF AND
PEDIATRICIAN AT NYU PROPOSE
TODAY USE NEWLY ADMITTED
CHILDREN WITH PARENT'S CONSENT
AND GIVE THEM HEPATITIS AND
STUDY THEM IN SPECIAL WARD AT
WILLOW BROOK TO UNDERSTAND
NATURAL HISTORY OF HEPATITIS A.
IDEA THAT TESTERS ARE USING
VULNERABLE CHILDREN GIVING THEM
DISEASE THAT DISTURBED MANY IDEA
IS WORKING TOWARDS EFFECTIVE
VACCINE AND WORK TOWARDS SPREAD
OF DISEASE AND THROUGHOUT CAREER
DEPENDED STUDIES AND MENTIONED
PARENTAL CONSENT THAT IN SOME
WAYS WAS SORT OF YOU KNOW HE WAS
IN VANGUARD.
CRITICS EMPHASIZED GROUP CONSENT
BRINGING PARENTS TOGETHER AND
TELLING ABOUT STUDY HAVING THEM
SIGN A BRIEF FORM AND MANY
PEOPLE HAVE FOUND THAT
PROBLEMATIC.
ALSO ISSUES ABOUT WITHHOLDING
GAMMA GLOBULIN FROM INFECTED
CHILDREN AND ESTABLISHING HAVING
A BENEFICIAL EFFECT.
NEXT SLIDE.
OTHER ONE THAT IS OR WOULD HAVE
BEEN KNOWN TO READERS OF NEW
YORK TIMES AND OTHER PAPER WAS
EXPERIMENTS CONDUCTED AT JEWISH
CONIC DISEASE HOSPITAL AND WHICH
THEY WERE INTERESTED IN STUDYING
WHAT LIVE CANCER CELLS DO IN
BODIES OF ELDERLY PATIENTS
FUNDED BY US PUBLIC HEALTH
SERVICE AND AMERICAN CANCER
SOCIETY AND DIDN'T GET CONSENT
OF ELDER WILL I PEOPLE AND
IDENTIFIED AT SEEN I'LL AND
DEMENTED AND REASON BEING DIDN'T
WISH TO STIR UP UNNECESSARY ANG
XI IT'S RTIES IN PATIENTS THAT
HAD PHOBIAS OF CANCER AND
CHESTER WAS PRINCIPLE
INVESTIGATOR AT MEMORIAL SLOAN
KETTERING AND DIDN'T DO HIS CASE
ANY FAVOR WHEN GAVE AN INTERVIEW
TO SCIENCE IN MAGAZINE OF AAAS
AND REPORTER ASKED HIM WOULD HE
EXPERIMENT ON HIMSELF WITH
INJECTIONS OF LIVE CANCER CELLS?
I WON'T READ LIVE QUOTE AND HE
SAID I WOULDN'T HAVE HESITATED
IF SERVING A USEFUL PURPOSE AND
GOES ON I DIDN'T REGARD
EXPERIMENT AS DANGEROUS AND LAST
SENTENCE I WILL CALL YOUR
ATTENTION TO AND FACING IT THERE
ARE RELATIVELY FEW SKILLED
CANCER RESEARCHERS AND SEEMED
STUPID TO TAKE THE LITTLE RISK
AND DIDN'T WIN HIM FRIENDS AND
ADMIRERS.
NEXT SLIDE.
AGAIN, PERHAPS THE SINGULAR AND
MOST IMPORTANT MOMENT THAT WAS
CAPPING MORE THAN A DECADE OF
DISCUSSIONS ABOUT LEGISLATION TO
PROTECT HUMAN SUBJECTS WAS
REVELATION OF TUSKEGEE CIVILIS
STUDY JULY 25TH, 1972.
STUDY BEGAN IN 1972 AND INTENDED
TO BE 6 MONTH STUDY AND WAS
ENDED BY DEPARTMENT OF HEALTH
AND EDUCATION WELFARE IN 1972
AND SEEN BY PUBLIC HEALTH
SERVICE SURGEON GENERAL THOMAS
PERRIN AFTER 1936 TO 1948 AND
PERRIN WAS A CRUSADER AGAINST
SYPHILIS AND OTHER SEXUALLY
TRANSMITTED DISEASES AND INTEND
ON VANQUISHING THESE DISEASES
FROM THE UNITED STATES AND SORT
OF OPENLY DISCUSSING THE SORT OF
TOLL THAT THIS DISEASE EXERTED.
NEXT SLIDE.
SO IT TURNS OUT THAT THEY DID IT
-- A STUDY, SIX COUNTIES OF
INCIDENTS OF SYPHILIS AND FOUND
THAT THEY HAD AN EXTRAORDINARILY
HIGH INCIDENCE.
IT WAS SELECTED BECAUSE THERE
WAS A VETERAN'S HOSPITAL FOR
AFRICAN AMERICAN SERVICEMAN IN
TUSKEGEE AND INITIAL 6 MONTH
STUDY AND FROM THE START IT
INVOLVED DECEPTION OF
PARTICIPANTS AND RAIFEN WHO
PLAYED AN IMPORTANT ROLE IN THE
STUDY WROTE LETTERS TO MEN
OFFERING WHAT HE CALLED LAST
CHANCE FOR SPECIAL FREE
TREATMENT FOR THEIR BAD BLOOD
AND TURNS OUT WHAT HE WAS
OFFERING WAS LUMBAR PUNCTURE A
COMPLETELY DIAGNOSTIC PROCEDURE
AND NOTHING CURATIVE ABOUT IT.
MEN FOUND IT VERY PAINFUL.
ACTUALLY, ONE THING I THINK IS
INTERESTING AND SUGGESTS THAT
THERE IS EVEN SOME LIMITED
AGENCY ON PART OF PARTICIPANTS
IS THAT THEY -- IT WAS DONE ONE
TIME ONLY BECAUSE RESEARCHERS
REALIZED IF THEY WANTED TO DO
MORE SPINAL PUNCTURES IN FUTURE
RESEARCH POPULATION WOULD
COMPLETELY ABSENT ITSELF FROM
FURTHER PARTICIPATION.
N SLIDE.
IN SOME -- AT SOMETIMES TUSKEGEE
WAS TALKED ABOUT STUDY OF NATURE
AND WERE MEN WHO WERE VERY POOR
AND DIDN'T HAVE MEDICAL CARE AND
WEREN'T GOING TO SEE A DOCTOR OR
GET TREATMENT.
PUBLIC HEALTH SERVICE TOOK STEPS
TO ENSURE THEY WOULDN'T GET
TREATMENT WHEN 254 OF MEN WERE
CALLED UP FOR MILITARY SERVICE
IN WORLD WAR II AND PUBLIC
HEALTH SERVICE INTERVENED WITH
DRAFT BOARD SAYING DON'T TAKE
THESE MEN.
WE -- THEY ARE IN OUR STUDY AND
WE WANT TO FOLLOW UNTREATED
SYPHILIS IF THEY HAD BEEN
INDUCTED IF INTO THE ARMY OR
HADN'T BEEN AND ONCE IDENTIFIED
AS CIVILITYIC WOULD HAVE
RECEIVED FREE TREATMENT FOR
THEIR DISEASE FROM THE ARMY.
NEXT SLIDE.
CRUCIAL TO THE SUCCESS OF THE
SOCIETY OF STUDY WAS NURSE
RIVERS A TRAINED NURSE
GRADUATING FROM TUSKEGEE
UNIVERSITY CRUCIAL IN BRIDGING
LARGE CULTURAL GAP BETWEEN
UNLETTERED FARMERS AND PUBLIC
HEALTH SERVICE RESEARCHERS WHO
CAME AT IRREGULAR INTERVALS OVER
THE 40 YEARS.
NEXT SLIDE.
NURSE RIVERS FOR EXAMPLE GIVEN
JOB OF OBTAINING PERMISSION FOR
POST MORTEM PARTICIPATION AND
INTERESTING TO ME THAT ONE THING
THEY ASKED THEM FOR WAS
PERMISSION FOR AUTOPSY AND THEIR
FAMILIES.
AND HER JOB BECAME EASIER WHEN
MILL BECK FUND OFFERED BURIAL
STIPEND $50 LATER RAISED TO 1
HUNDRED DOLLARS AND REPORTED IN
PUBLIC HEALTH REPORTS IN 1953
ARTICLE HAD ONE REFUSAL IN 140
REQUESTS.
NEXT SLIDE.
SO THE STUDY WAS NOT A SECRET
AND WERE 13 PUBLICATIONS BETWEEN
1936 AND 1970 TO YOU ARE IN OPEN
MEDICAL LITERATURE AND IN 1954
AFTER THINGS LIKE THE
PUBLICATION IN SCIENCE AT
NUREMBERG CODE THAT FOR FIRST
TIME IN STUDY THEN WERE
IDENTIFIED AS QUOTE VOLUNTEERS
WITH SOCIAL INVENTIVES.
NEXT SLIDE IN AN EFFORT TO
PROMOTE KIND OF THE KNOWLEDGE
THAT THEY WERE IN A MEDICAL
RESEARCH STUDY IN 1957, THE
PUBLIC HEALTH SERVICE REWARDED
MEN WITH A CERTIFICATE SIGNED BY
THE SURGEON GENERAL.
EACH MAN IN THE STUDY RECEIVED A
DOLLAR FOR EVERY YEAR THEY HAD
PARTICIPATED AND RECEIVED $25
AND THIS CERTIFICATE THAT SAYS
ACTIVE PARTICIPATION IN THE
TUESDAY KEITHEE MEDICAL RESEARCH
STUDY THAT DIDN'T TRANSLATE
NECESSARILY TO MEN WHO STILL MAY
NOT HAVE KNOWN THAT THEY WERE
ACTIVELY PARTICIPATING IN
MEDICAL RESEARCH.
>> SUSAN.
>> YES.
>> WE ARE AT TIME.
>> ALREADY. OKAY.
>> MAYBE YOU CAN FINISH UP WITH
TUS KEITHEE AND FOLKS INTERESTED
CAN LOOK AT GAUT MALA STUDY.
>> I'M VERY SORRY AND VIRTUALLY
DONE WITH TUSKEGEE AND GOING TO
SAY BLUE RIBBON PANEL BUT STUDY
COULD I HAVE NEXT SLIDE UP.
>> THAT IS UP 19691.
>> NEXT SLIDE, PLEASE.
1972 THAT STUDY IS REVEALED AND
NEXT SLIDE.
1974 THERE ARE HEARINGS AND
PRESIDING BY SENATOR TED KENNEDY
AMONG OTHERS AND CREATION OF
NATIONAL COMMISSION TO STUDY
MORAL ISSUES POSED BY HUMAN
EXPERIMENT
EXPERIMENTATION.
THIS IS ORGANIZATION THAT
SPONSORS PUBLICATION OF BELMONT
REPORT THAT YOU HEARD SO MUCH
ABOUT.
OKAY. WELL, I -- I'M SORRY.
I THOUGHT I STILL HAD MORE TIME.
>> THAT SOW KAY.
>> I APOLOGIZE FOR GOING OVER
TIME.
>> IT IS QUITE ALL RIGHT.
AND ONE OF THE THINGS I WILL SAY
IS THAT I CERTAINLY HOPE I
WETTED YOUR APPETITE FOR AN
INTEREST IN THE HISTORY OF HUMAN
EXPERIMENTATION AND IF YOU HAVE
QUESTIONS OR YOU WOULD LIKE
RECOMMENDATIONS FOR READING
ABOUT THIS INTERESTING AND
COMPELLING HISTORY, I WELCOME
YOU, E-MAIL FROM YOU IF THAT
WOULD BE DESIRABLE.
>> TERRIFIC.
>> THANK YOU SO MUCH, SUSAN.
ROUND OF APPLAUSE FROM MOST THAT
ARE HERE AND WE NOW GET TO SEE
YOU, WHICH IS LOVELY.
>> OKAY.
>> WE HAVE FOLKS HERE IN THE
AUDITORIUM WHO MAY HAVE
QUESTIONS AND I'M GOING TO SEND
THEM TO THE MICS.
>> OKAY.
>> I WILL CHECK THE DISCUSSION
BOARD TO SEE IF WE HAVE
QUESTIONS FROM THOSE WHO ARE
LOGGING IN.
WE HAVE BRIT ANY WITH A
QUESTION.
A HISTTO RIAN.
>> I'M BRITTNEY AND HISTORIAN IN
BIOETHICS, BRAND NEW.
>> YES.
>> I WAS WONDERING ABOUT
IMPLICATIONS OF TUSKEGEE BEYOND
PARTICIPANTS IF NOT INFORMED OF
THEIR SYPHILIS STATUS AND PEOPLE
WHOM THEY WERE HAVING RELATIONS
MIGHT HAVE ALSO BEEN EFFECTED BY
THEIR LACK OF TREATMENT AND WHAT
KIND OF CONSIDERATIONS WERE PUT
IN PLACE FOR THOSE PEOPLE WHO
WEREN'T ENROLLED IN THE STUDY.
>> WELL, THAT IS A VERY
INTERESTING AND IMPORTANT
QUESTION.
THE ASSUMPTION OF THE
INVESTIGATORS WAS THAT -- THESE
WERE PEOPLE WHOSE CIVILITYIC
INFECTION AND MEN IN THE STUDY
AND CIVILITYIC INFECTION WAS AT
LEAST OF FIVE YEARS AND THEY
WERE BELIEVED TO HAVE -- BE NO
LONGER INFECTIOUS.
THE WHOLE -- THE WHOLE
UNDERSTANDING OF HOW AND WHY AND
UNDER WHAT CIRCUMSTANCES YOU
COULD GET SUPER INFECTED OR
REINFECTED IS MURKY AND NOT
DISCUSSED AND DON'T BELIEVE
THERE WAS ANY -- THERE WERE ANY
PLANS, YOU KNOW, TO PROTECT, YOU
KNOW, PARTNERS AND CHILDREN.
CERTAINLY AS WE KNOW, I MEAN,
WHAT IS HAPPENING TODAY, THERE
HAS BEEN TREMENDOUS INCREASE IN
CONGENITAL SYPHILIS FOR EXAMPLE
AS THE DISEASE HAS BECOME SORT
OF -- HAS BECOME MORE
WIDESPREAD.
IT IS AN EXCELLENT QUESTION.
IT DOES NOT SEEM TO BE SOMETHING
THAT WAS ON THE AGENDA AND OF
THE PUBLIC HEALTH SERVICE AND
FRANKLY I DON'T SEE MUCH
DISCUSSION ABOUT IT, YOU KNOW,
IN THE 1970S.
>> THANK YOU. I'M WONDERING AND
DON'T SEE ANYONE RUNNING TO THE
MICROPHONE AND WOULD LOVE TO
GIVE YOU AN OPPORTUNITY TO TELL
US ABOUT THE -- AT LEAST THE
LEGACY OF THE TUSKEGEE STUDY
THROUGH THE CLINTON
ADMINISTRATION.
>> SURE. WHAT I WAS GOING TO
SAY IS THAT SO IN -- IN A STUDY
FORMALLY ENDS, IN 1973, IT DOES
HAVE THIS IMPACT ON THE -- YOU
KNOW, ON NATIONAL RESEARCH ACT.
I THINK THAT THERE REMAIN, YOU
KNOW, DIFFERENT AUDIENCES FOR
TUSKEGEE SYPHILIS STUDY AND IN
AFRICAN AMERICAN COMMUNITY I
THINK THERE WAS MUCH GREATER
SORT OF KNOWLEDGE ABOUT THE
STUDY AND AT LEAST -- AT LEAST
IN SOME CASES A BELIEF THAT THE
MEN IN THE STUDY WERE ACTUALLY
INFECTED THAT I THINK IS NOT THE
CASE BUT NEVERTHELESS, I THINK
THERE ARE GOOD REASONS TO
BELIEVE THAT THERE WERE.
I THIS I IT CAME AS -- WHAT SORT
OF THE WHITE MEDICAL
ESTABLISHMENT THAT CAME AS A
HUGE SHOCK WAS IN 1992, SORT OF
IN THE MIDST OF, YOU KNOW, THE
AIDS EPIDEMIC AND WAS
RECOGNITION.
I REMEMBER CLEARLY PUBLICATION
OF EDITORIAL IN NEW YORK TIMES
THAT WAS ASTOUNDED THAT
AFRICAN-AMERICANS MIGHT BE
RELUCTANT TO PARTICIPATE IN
RESEARCH INVOLVING HIV AND THEY
MIGHT BE RELUCTANT TO TAKE A
VACCINE THAT WAS DEVELOPED BY
THE FEDERAL GOVERNMENT.
AGAIN, THAT IS PART OF THE -- I
WOULD SAY LONGSTANDING LEGACY AT
LEAST IN SOME ELEMENTS OF THE
AFRICAN AMERICAN COMMUNITY AND
DISTRUST OF THE ROLE OF THE
FEDERAL GOVERNMENT AND THINK ONE
THING THAT I FOUND INTERESTING
IS THAT I DISCOVERED IN 1994
THAT THERE HAD BEEN NO APOLOGY
OR WAS A FINANCIAL SETTLEMENT
OUT OF COURT THAT THE GOVERNMENT
ENTERED INTO THAT AWARDED MEN IN
STUDY OR FAMILY'S $32,000 AND
LIFELONG MEDICAL CARE IF THEY
WANTED IT.
YOU KNOW, BURIAL STIPEND.
BUT THERE HAD BEEN NO
PRESIDENTIAL APOLOGY.
I THINK THAT IT WAS IN THE WAKE
OF THE PRESIDENT -- PRESIDENT
CLINTON'S APOLOGY TO THOSE
AMERICANS WHOSE LIVES HAD BEEN
DARKENED BY THE SHADOW OF THE
ATOM AND MAINLY HUMAN RADIATION
EXPERIMENTS AND REVELATION OF
LARGE SCALE EXPOSURE OF
AMERICANS TO IONIZING RADIATION
IN THE COLD WAR AND PRESIDENT
CLINTON OFFERED APOLOGIES AND
YEAR LATER INVITED MEN FROM
STUDY OR SURVIVORS TO THE WHITE
HOUSE FOR A FEDERAL APOLOGY.
THIS CAME WITH THE ESTABLISHMENT
OF A BIOETHICS INSTITUTE AT
TUSKEGEE UNIVERSITY AND FUNDS TO
EXPLORE SORT OF LONGSTANDING
RACIAL DISPARITIES IN HUMAN
EXPERIMENTATION IN BOTH RISKS
AND BENEFITS.
>> AT TIME ARE 3 OR 4 MEN THAT
REMAINED ALIVE AT SESSION WITH
PRESIDENT CLINTON AND THINK LAST
SURVIVING MAN PASSED A NUMBER OF
YEARS AGO.
>> YES. THAT IS RIGHT. I THINK
TODAY -- THERE IS -- IF PEOPLE
ARE INTERESTED I CAN RECOMMEND
TWO VIDEO INTERVIEWS OR PROGRAMS
THAT I THINK ARE VERY REVEALING
THAT HAVE BENEFIT OF YOU GET TO
SEE SOME OF THE INVESTIGATARS OR
ONE INVESTIGATOR THAT WAS STILL
SURVIVING AND SOME MEN IN THE
STUDY THAT GIVES YOU A MUCH MORE
APPRECIATION FOR WHAT THEY
EXPERIENCED OVER THE COURSE OF
THE FOUR YEARS AND SUBSEQUENT AS
WELL.
>> THAT WOULD BE GREAT AND WE
COULD POST THAT FOR EVERYONE TO
TAKE A LOOK.
WELL, THANK YOU VERY MUCH,
SUSAN.
WE VERY MUCH APPRECIATE YOUR
VISITING US TODAY.
AND THANK YOU AGAIN.
>> ALL RIGHT. THANK YOU, HOLLY.
>> BYE, BYE.
>> SO AS I SAID, WE WILL TAKE A
15 MINUTE BREAK AT THIS POINT.
PLEASE BE BACK IN 15 MINUTES
WHICH WILL BE ABOUT 10:50.
YOU WILL HEAR FROM ME ABOUT IRBS.
>> AT LEAST TWO REALLY IMPORTANT
PILLARS IN PROTECTION OF
SUBJECTS OF HUMAN RESEARCH AND
ONE IS THE INSTITUTIONAL REVIEW
BOARD THAT WE WILL TALK ABOUT
AND SECOND IS INFORMED CONSENT.
THE INSTITUTIONAL REVIEW BOARD'S
RESPONSIBILITY IS MAKING SURE
THAT WHAT THEY REVIEW IS
RESPECTING PARTICIPANTS AND IN
WAY THAT IS APPROPRIATE, ET
CETERA.
ONE CAN ASSUME OR SYSTEM IS SET
UP SO ONE CAN ASSUME THAT IF
REVIEW BOARD APPROVED RESEARCH
IT IS CONSIDERED SAFE FOR AN
INDIVIDUAL TO PROVIDE INFORMED
CONSENT THEN.
IF WE DIDN'T HAVE INSTITUTIONAL
REVIEW BOARDS, INVESTIGATORS
COULD GO DIRECTLY TO INDIVIDUALS
ASKING THEM TO BE IN THEIR
RESEARCH AND SAW EXAMPLES HOW
THAT COULD GO WRONG AND REMINDER
WHEN WE TALK ABOUT HOW SYSTEM
PROTECTS SUBJECTS WE CAN TALK
ABOUT THE REVIEW AND WHOLE DAY
ON INFORMED CONSENT AND DR.
GRADY WILL BE BACK AND DR. SCOTT
KIM ON FACULTY WILL BE BACK AND
SOMEONE FROM NATIONAL INSTITUTE
OF MENTAL HEALTH TALKING ABOUT
HOW THEY ASSESS CAPACITY HERE AT
THE CLINICAL CENTER.
HERE ARE KEY POINTS I WANT YOU
TO GET AND FIRST IRBS ARE
RESPONSIBLE FOR REVIEW AND
OVERSIGHT OF ALL HUMAN SUBJECT
RESEARCH CONDUCTED IN THE UNITED
STATES AT AN ACADEMIC MEDICAL
CENTER THAT HAS SOUGHT AND
GAINED FEDERAL WIDE ASSURANCE
FROM OFFICE OF HUMANWIDE
PROTECTIONS THAT IS HHS LEVEL
OFFICE TO REVIEW ALL RESEARCH
THAT HAPPENS AT THEIR
INSTITUTIONS AND WILL TALK MORE
ABOUT THAT.
I WANTED TO MAKE JUST THE POINT
THAT OUTSIDE OF THE UNITED
STATES, THESE BODIES ARE ETHICAL
REVIEW BOARDS RESEARCH ETHICS
COMMITTEES AND INDEPENDENT
ETHICS COMMITTEES, ET CETERA.
THOSE THAT ARE IN PLACES LIKE
THE UNITED STATES, A LOT OF WHAT
I WILL COVER IS SIMILAR TO WHAT
BOARDS DO IN OTHER COUNTRIES.
TODAY, MOST COUNTRIES THAT
ACTIVELY ENGAGE IN HUMAN SUBJECT
RESEARCH HAVE REVIEW AND
OVERSIGHT MECHANISMS TO PROTECT
CITIZENS OF THEIR COUNTRY OR
REGION.
AND IN THE UNITED STATES, IRBS
ARE GUIDED IN REVIEW BY TWO
FEDERAL REGULATIONS DR. GRADY
MENTIONED AFRND ONE THAT COVERS
ALL OF HHS.
KEY COMPONENT OF THAT APPLIES TO
COMMON RULES AND APPLIES TO 17
OTHER FEDERAL DEPARTMENTS AND
DEPARTMENT OF ENERGY AND
DEPARTMENT OF HOUSING AND URBAN
DEVELOPMENT, ET CETERA.
SO THE KEY FEDERAL REGULATIONS
IN THE UNITED STATES ARE HHS
ONES AND WHEN COMING TO REVIEW
AND APPROVAL OF DRUGS, FDA KICKS
IN AS WELL AND THEY ARE VERY
SIMILAR AND IRBS IN THE UNITED
STATES ARE LOCAL MEANING THAT
EVERY ACADEMIC MEDICAL INSTITUTE
THAT IS KWON DUCTING HUMAN
SUBJECT RESEARCH HAS A LOCAL IRB
OR MULTIPLE IRBS AND USED TO
WORK AT JOHN'S HOPKINS SITTING
ON MEDICAL SCHOOL IRB AND THERE
WERE 7IRBS TO REVIEW AND APPROVE
ALL RESEARCH HAPPENING AT
INSTITUTION AND WERE ALL LOCAL
IN SENSE WE NEEDED 7 TO KEEP UP
WITH RESEARCH THAT WAS GOING ON
AND GROUPS CAN DEVELOP POLICY
AND PRACTICE BASED ON FEDERAL
REGULATIONS AND CAN BE MORE
STRICT AND FEDERAL REGULATIONS
ARE BASELINE AND OUTSIDE OF THE
U SC
USIRBS ARE LOCAL AND SOMETIMES
REGIONAL AND IN UK IS DONE BY
REGIONS AND IN OTHER COUNTRIES
THERE IS A NATIONAL IRB AND
UGANDA, FOR EXAMPLE, THERE ARE
BOTH LOCAL COMMITTEES ATTACHED
TO ACADEMIC INSTITUTIONS AND A
NATIONAL IRB.
ALL TO SAY FOR THOSE OUT THERE
THAT ARE NOT IN THE US, YOU
MIGHT WANT TO FIND OUT HOW THE
SYSTEM WORKS IN YOUR SETTING.
ONE THING I WANTED TO SAY IS IF
YOU ARE DOING RESEARCH AND HAVE
A QUESTION AND YOU DON'T KNOW IF
IT NEEDS TO BE -- RESEARCH NEEDS
TO BE SUBMIT TODAY IRB OR
THINKING ABOUT RESEARCH YOU ARE
PLANNING, ASK THEM.
THEY ARE THERE TO HELP
INVESTIGATORS NAVIGATE THEIR
RESEARCH AND MAKE SURE THAT IT
MEETS ETHICAL STANDARDS AND WHEN
IN DOUBT, GO AND FIND THAT
INSTITUTION WHETHER IT IS LOCAL,
REGIONAL, NATIONAL AND ASK THEM
QUESTIONS THIS IS REITERATION OF
INDEPENDENT REVIEW ETHICAL
REQUIREMENT AND IRB IS MEANT TO
REVIEW RESEARCH AND MEANT TO BE
REVIEWED BY INDIVIDUALS NO THE
CONDUCTING RESEARCH AND GOAL IS
TO ASSURE SOME PUBLIC OR SOCIAL
ACCOUNTABILITY; RIGHT?
IF YOU ARE THINKING ABOUT
ENROLLING IN RESEARCH YOU MIGHT
HAVE NO IDEA WHAT AN IRB IS.
IF YOU DID IT WOULD GIVE YOU A
SENSE THAT A LEARNED BODY
REVIEWED RESEARCH AND CONSIDERED
IT SAFE AND IRB IS ALSO THERE TO
MINIMIZE IMPACT OF POTENTIAL
RESEARCHER CONFLICT OF INTEREST.
AND THIS IS JUST A GREAT QUOTE
THAT I REALLY USE EVERY TIME
THAT I TALK ABOUT IRBS FROM
EDGAR AND ROTHMAN BACK IN 1995
AND UNQUESTIONABLY, THEIR VERY
EXISTENCE TEMPERED INEVITABLE
PROPENSITY OF RESEARCHERS TO
PURSUE INVESTIGATIONS WITHOUT
DISPASSIONATELY OUTWEIGHING
RISKS AND ASKING OTHERS TO
ASSUME AND FULLY INFORM SUBJECTS
OF THEM AND ANOTHER WAY TO SAY
THIS IS THAT JUST THAT IRBS
EXIST HOPEFULLY IN THEIR MIND
AND REMIND INVESTIGATORS THAT
THEY HAVE TO THINK ABOUT
SUBJECTS AND THEIR RESEARCH AND
THERE IS A BODY THAT WILL
REVIEW.
ON ONE HAND, INVESTIGATORS MIGHT
THINK, OH, MY GOSH; RIGHT?
THIS MIGHT BE A CURE AND THEY
MIGHT OVERESTIMATE POTENTIAL
BENEFIT AND WHY YOU HAVE THE
INSTITUTIONAL REVIEW BOARD TO
ADDRESS THAT SORT OF INHERENT
PERSONAL CONFLICT; RIGHT?
IF I'M DOG A RESEARCH PROJECT, I
COURSE I THINK IT WILL WORK.
WE DO RESEARCH TO FIND OUT IF IT
WOULD WORK AND IF WE KNEW IT
WORKED WE WOULDN'T HAVE TO DO
RESEARCH AND IRB IS SAYING
PLANNING AND SOUND AND PROTECTS
SUBJECTS AND IS A BIT OF A GARD
RAIL FOR INVESTIGATORS COMING TO
CONFLICT OF INTEREST.
I WILL TOUCH ON A NUMBER OF KEY
COMPONENTS WHAT IRBS DO AND
HAPPY TO ANSWER QUESTIONS AND
WILL ALWAYS BE THE CASE, WE HAVE
PUT READINGS ON CANVAS FOR THOSE
THAT WANT TO LEARN MORE ABOUT
IRBS AND ARE ARTICLES ABOUT IRBS
IF YOU HAVE QUESTIONS ABOUT THEM
CAN YOU ASK THEM TODAY OR ASK
THEM AS WE MOVE FORWARD IN THE
CLASS.
WHAT IS THEIR ROLE?
AS I SAID, THEIR ROLE IS TO
REVIEW AND OVERSEE ALL OF THE
HUMAN SUBJECT RESEARCH THAT IS
HAPPENING AT AN INDIVIDUAL
INSTITUTION.
IN THE UNITED STATES, IRB, WHEN
I SAY INSTITUTIONAL REVIEW
BOARD, I'M REFERRING TO THE
GROUP OF INDIVIDUALS WHO ARE
BROUGHT TOGETHER TO REVIEW A
PARTICULAR PROTOCOL OR PROTOCOLS
AND DECIDE WHETHER OR NOT THEY
OUGHT TO BE APPROVED OR NOT
OFTEN IN THE UNITED STATES IRBS
ARE ONE COMPONENT OF WHAT IS
REFERRED TO AS HUMAN PROTECTION
RESEARCH PROGRAM AND SOME
INSTITUTIONS HAVE IRBS BUT THERE
HAS TO BE AN ADMINISTRATIVE
INFRASTRUCTURE FOR THAT IRB TO
BE SUPPORTED AND I MAY REFER TO
TODAY AND MOVING FORWARD THE
HUMAN RESEARCH PROTECTION
PROGRAM TO CONVEY THE SORT OF
ADMINISTRATIVE BODY THAT IS IN
CHARGE AND IN THE UNITED STATES
ACCORDING TO FEDERAL
REGULATIONS, IRBS MUST HAVE AT
LEAST FIVE MEMBERS.
THERE ARE REQUIREMENTS FOR FIVE
MEMBERS AND ONE HAS TO BE
AFFILIATED WITH THE INSTITUTION
AND ONE HAS TO BE A
NONSCIENTIST.
WHEN I'M NOT TEACHING, I DO LOTS
OF EMPIRICAL RESEARCH ABOUT
RESEARCH ETHICS AND WORKED ON A
STUDY A COUPLE YEARS AGO WHERE
IRBS HAVE ONE PERSON THAT IS
UNAFFILIATED AND ONE
NONSCIENTIST AND MEANS THERE IS
ONE PERSON WHO IS NOT A
PHYSICIAN OR PHD TRAINED
SCIENTIST AND THAT IS HARD.
OOPS. SORRY TO BE THE ONLY
PERSON NOT A SCIENTIST IN THE
ROOM.
SOME COUNTRIES LIKE NEWSDAEL
YOIND FOR EXAMPLE HAVE VERY
DIFFERENT APPROACHES AND THEIR
EQUIVALENT INSTITUTIONAL REVIEW
BOARD HAS TO HAVE ONE MORE
MEMBER OF THE COMMUNITY THAN
THERE ARE SCIENTISTS.
IF FOUR SCIENTISTS THEY HAVE TO
HAVE FIVE COMMUNITY MEMBERS.
THANK YOU DIFFERENT COUNTRIES
SET UP SYSTEMS IN DIFFERENT WAYS
TO MAKE SURE THAT VOICE IS SORT
OF AT THE TABLE AND ARE A NUMBER
OF CHALLENGES IN SORT OF
ESSENTIAL TO AN INSTITUTIONAL
REVIEW BOARD.
ONE IS THE INDIVIDUAL.
WE CAN QUICKLY DEAL WITH THAT
WITH IRBS. I HAPPEN TO BE ON
IRB BOARD AT CLINICAL CENTER AND
SUBMITTING RESEARCH TO THE IRB,
I CAN'T BE ON IRB WHEN RESEARCH
IS REVIEWED; RIGHT?
THAT IS A CLEAR WAY TO REMOVE
CONFLICT OF INTEREST I WOULD
HAVE IF I WAS SITTING IN THE
ROOM AND I WOULD SAY OF COURSE
IT IS AWESOME AND NEEDS TO BE
APPROVED.
LET'S SAY MY SUPERVISOR AND DR.
GRADY IS MY SUPERVISOR AND I'M
WORKING WITH CHRISTINE ON A
PROJECT AND HER PROJECT COMES TO
ME AT IRB AND WILL RAISE MY HAND
AND EVERYBODY THIS IS MY BOSS
WHO HAS A SUPERVISORY ROLE OVER
ME AND DON'T FEEL I'M BEST
PERSON TO REVIEW AND CAN
SELF-RECUSE MYSELF FROM THE
DELIBERATIONS.
NOW, OUTSIDE OF THE NIH, ALMOST
ALL RESEARCH CONDUCTED AT
ACADEMIC MEDICAL CENTERS IS
FUNDED BY NATIONAL INSTITUTES OF
HEALTH.
IMAGINE YOU ARE AN IRB MEMBER
AT, WE WILL USE JOHN'S HOPKINS
AS AN EXAMPLE.
WHAT HAPPENS IS IF YOUR GRAND TO
THE NIH IS FUNDED IT IS REVIEWED
BY INSTITUTIONAL REVIEW BOARD AT
YOUR INSTITUTION BEFORE IT COULD
BE IMPLEMENTED.
IF THE IRB IS THE SORT OF ONLY
THING BETWEEN THE RESEARCH
GETTING DONE AND THE -- YOU
KNOW, GETTING THE FUNDING, THEN
IRB ITSELF HAS A CONFLICT OF
INTEREST; RIGHT?
IF THE IRB DOESN'T APPROVE IT,
THE INSTITUTION DOESN'T GET THE
MONEY.
THAT IS NO THE TO SAY THAT
THEREFORE ALL IRBS ARE
ESSENTIALLY CONFLICTED AND CAN'T
DO THEIR JOB.
UNFORTUNATELY IT DOESN'T MEAN
THAT.
I MAKE THAT POINT BECAUSE THERE
ARE CONFLICTS OF INTERESTS AND
TENSIONS WHEN WE TALK ABOUT
ETHICS AND TALK ABOUT THE
INFRASTRUCTURE DEVELOPED TO SORT
OF OVER VIEW AND OVERSEE ETHICS
IN ANY -- YOU KNOW, ANY SORT OF
SYSTEM SETUPS AND INSTITUTIONAL
REVIEW BOARDS AND INFORMED
CONSENT AND QUICK DIGRESSION TO
INFORMED CONSENT AND I'M
INVESTIGATOR AND SOMEONE YOU
WANT TO ENROLL IN YOUR STUDY AND
MIGHT HAVE INCENTIVE TO NOT TELL
YOU ABOUT REALLY PROBLEMATIC
RISK EVEN THOUGH IN THE FORM AND
WON'T POINT IT OUT. I WANT YOU
TO REALLY ENROLL AND ONLY TO SAY
THIS WILL BE A THEME AS WE MOVE
FORWARD THAT THERE WILL BE
CHALLENGED EVEN WHEN WE SET UP
SYSTEMS TO HOPEFULLY MAKE THE
SYSTEM WORK.
GROUP DYNAMICS IS ANOTHER ISSUE
THAT RELATES TO IRBS.
SO I HAVE SERVED ON MANY IRBS
OVER THE MANY YEARS OF MY
CAREER.
AND THEY ARE BODIES THAT
SOMETIMES HAVE BEEN TOGETHER FOR
T10 OR 15 MORE YEARS AND SOME
IRBS DON'T HAVE ANY TERM LIMITS.
YOU CAN ENCOUNTER OBSERVER DRIFT
OR SORT OF EVERYONE SEES TO THIS
PERSON WHEN IT COMES TO THAT OR
CHAIR HAS A LOT OF SAY OR SWAY.
THERE ARE THINGS ANY GROUP THAT
IS TOGETHER A LONG TIME MIGHT
ENCOUNTER AND BECAUSE OF THAT
IRBS DO SET TERM LIMITS.
WHEN AT SCHOOL OF PUBLIC HEALTH
AT HOPKINS, YOU COULD SERVE FOR
THREE YEARS AND ROTATE OFF AND
GROUP WAS -- ALWAYS HAD SOME
CARRYOVER AND NOT EVERYBODY'S
TERM LIMIT ENDED AT THE SAME
TIME AND WAS A WAY TO SORT OF
ADDRESS BOTH MEETING THE
EXPERTISE AND AVOIDING GRUPP
THINK SORT OF ATTITUDES.
WHY DO WE NEED THIS IRB? I
ELUDED TO THIS ALREADY.
WHEN AN ACADEMIC MEDICAL CENTER
SETS UP FEDERAL RIDE ASSURANCE
WITH FEDERAL GOVERNMENT THEY SAY
IN DOCUMENTATION THAT I WILL
REVIEW ALL RESEARCH AT MY
INSTITUTION REGARDLESS OF THE
SOURCE OF FUNDING AND MEANS THAT
AN ACADEMIC MEDICAL CENTER ALL
RESEARCH WHETHER NIH OR GATES
FUNDED OR SELF-FUNDED
DISCRETIONARY FUND FUNDED, ET
CETERA, IT IS ALL REVIEWED.
YOU CAN'T ESCAPE, QUOTE ON
QUOTE, THE REVIEW BY GETTING
FUNDING FROM A SOURCE OTHER THAN
THE NATIONAL INSTITUTES OF
HEALTH WHEN IN THE US AND FDA
REQUIRES IRB REVIEW ALSO.
PHARMACEUTICAL COMPANIES HOPING
TO SEND A PACKAGE OF MATERIALS
FOR MARKETING DRUG IN THE
FUTURE, FDA WILL SAY DID YOU
HAVE AN IRB REVIEW CLINICAL
PROTOCALS AND NEED TO SAY OF
COURSE I DID AND FEDERALWIDE
ASSURANCE I MENTIONED AND
REITERATES IDEA THAT YOU AGREE
TO REVIEW ALL -- YOU REVIEW ALL
RESEARCH REGARDLESS OF FUNDING
AND TWO OTHER THINGS ABOUT THIS
FWA AND ONE IS INSTITUTIONS
OUTSIDE OF THE UNITED STATES CAN
REQUEST A FEDERALWIDE ASSURANCE
THAT IS WEIRD AND HAPPENS AND
YOU HAVE TO NOTE WHICH
REGULATIONS OR ETHICAL CODE YOU
WILL FOLLOW AND IN UNITED STATES
IT IS ALMOST ALWAYS THE BELMONT
REPORT AND IN INTERNATIONAL
ORGANIZATIONS, OFTEN THEY WILL
SAY THE DECLARATION OF HELSINKI.
THEY DON'T HAVE THE BELMONT
REPORT THAT IS US CENTRIC AND
DECLARATION OF HELSINKI IS MEANT
TO BE INTERNATIONAL SET WHAT
STANDARD YOU ARE USING AS YOUR
BASELINE AND IN TERMS OF
RESPONSIBILITIES DR. GRADY
MENTIONED THEM QUICKLY AND THESE
ARE REVIEW CRITERIA IN THE
FEDERAL REGULATIONS AND I WANT
YOU TO NOTICE THAT THIS IS
VERBATIM.
OKAY?
THIS IS ALL DIRECTION THAT IRB
GETS AND RISK MINIMIZED AND
REASONABLE WHEN COMPARED WITH
BENEFIT AND IS LOTS OF
DISCRETION AND RESPONSIBILITY ON
BEHALF OF IRB TO FIGURE OUT WHAT
ARE RISKS AND MINIMIZED AND
REASONABLE AND WHAT ARE BENEFITS
AND REGULATIONS JUST DON'T GIVE
IRBS A LOT OF HELP WHICH MEANS
THAT MOST IRBS DEVELOP POLICIES
FOR THEIR INVESTIGATORS AND IRB
MEMBERS TO FOLLOW AND ARE
ADDITIONAL REVIEW CRITERIA AND
MOST IRBS WILL MAKE SURE THEY
TICK A BOX RELATED TO EACH OF
THESE THINGS THAT WE CHECKED AND
MADE SURE THAT EACH OF THESE
THINGS IS TRUE CHECKING BEAU.
THAT SAFETY AND MONITORING
PROVISIONS ARE IN PLACE IS NOT
LOOKING AT PROVISIONS AND YOU
ARE IN FACT SURE THEY ARE
ADEQUATE FOR MONITORING SAFETY
AND THERE IS ADDITIONAL.
IF A PROJECT IS FUNDED BY NIH
IRB NEEDS TO MAKE SURE IT IS
COMPLIANT WITH GUIDELINES AND
STATES HAVE PARTICULAR LAWS FOR
IRBS AND IN MARY LOIRND WE NEED
TO KNOW WHAT STATE LAWS ARE AND
CHRISTINE MENTIONED PULLED
TOGETHER FOR NATIONAL RESEARCH
ACT AND THEY PUT OUT A LOT OF
RECOMMENDATIONS AND ALL
SUBSEQUENT NATIONAL COMMISSIONS
HAVE BIG CREATED BIG REPORTS AND
MANY ON SHELF IN MY OFFICE THAT
ADD ADDITIONAL RECOMMENDATIONS.
SO IT IS UP TO THE IRB TO DECIDE
WILL WE FOLLOW THOSE
RECOMMENDATIONS AND USE THEM TO
DRAFT OUR LOCAL POLICY AND
PLENTY TO INCORPORATE.
NOW, WHAT IRBS NEED TO DO IS
REVIEW RESEARCH.
THIS IS HOW RESEARCH IS DEFINED
IN REGULATIONS AND SYSTEMATIC
INVESTIGATION INCLUDING RESEARCH
DEVELOPMENT, TESTING, AND
EVALUATION AND DESIGNED TO
CONTRIBUTE TO GENERALIZABLE
KNOWLEDGE AND SHOULD REMIND YOU
OF SCIENTISTIC VALIDITY AND SO
THE IDEA HERE IS THAT IF YOU ARE
DOING THIS, YOU HAVE TO GO TO
THE IRB.
NOW, THIS CREATES SOME CONCERNS.
SO I DO A LOT OF QUALITATIVE
RESEARCH.
MY INTENT IS NOT TO CONTRIBUTE
TO GENERALIZABLE KNOWLEDGE AND
I'M EXPLORING PHENOMENON TO
IDENTIFY THEMES AND PATTERNS
THAT MIGHT BE TRANSFERABLE TO
ANOTHER SETTING AND AM I DOING
RESEARCH?
ABSOLUTELY.
THIS IS WHAT IS WRITTEN IN THE
CODE AND IRBS NEED TO THINK
ABOUT WHAT DOES THAT REALLY MEAN
FOR MY INSTITUTION?
IF PEOPLE LIKE HOLLY, I DON'T
WANT HER RESEARCH NOT TO BE
REVIEWED AND WE HAVE TO MAKE
SURE EVERYONE KNOWS WE ARE
REVIEWING QUALITATIVE WORK AS
WELL.
THESE ARE POTENTIAL CATEGORIES
THAT IRB WILL APPLY TO YOUR
RESEARCH AND ONE, THEY CAN SAY
IT IS NOT HUMAN SUBJECT RESEARCH
AND THEREFORE NOT REQUIRED TO
FOLLOW ALL RULES AND REGULATIONS
AND SOME RESEARCH IS EXEMPT FROM
IRB REVIEW.
YOU STILL HAVE TO SUBMIT YOUR
RESEARCH TO THE IRB FOR THEM TO
DETERMINE IT IS EXEMPT.
ONE THING THAT ALL OF THE
CATEGORIES HAVE IN COMMON IS IT
IS NO MORE THAN MINIMAL RISK AND
MEETS THE CRITERIA AND ONE MOST
RELEVANT TO ME AND MY COLLEAGUES
HERE AT DEPARTMENT OF BIOETHICS
IS IT IS DATA COLLECTED WITHOUT
IDENTIFIERS AND IF I DID A
SURVEY OF ALL OF YOU ABOUT WHAT
YOU ATE FOR BREAKFAST THIS
MORNING AND SOCIAL VALUE QUITE
LOW.
I WOULD SAY WE WILL DO THIS.
I WON'T COLLECT YOUR NAMES BUT
WANT YOU TO ANSWER THE
QUESTIONS.
THAT WOULD QUALIFY AS EXEMPT
FROM IRB REVIEW.
THOUGH THEY SHOULDN'T APPROVE IT
BECAUSE THERE IS NO SOCIAL
VALUE.
THE NEXT CATEGORY IS EXPEDITED
REVIEW AND EXPEDITED IN THIS
CASE DOESN'T MEAN FASTER.
IT MEANS THAT THE RESEARCH THAT
YOU ARE SUBMITTING IS NO MORE
THAN MINIMAL RISK.
IT CAN BE REVIEWED BY A
CHAIRPERSON OR EXPERIENCED
REVIEWER AND TECHNICALLY COULD
BE FASTER AND IS NOT ALWAYS
FASTER.
THE FINAL AND SORT OF MOST
IMPORTANT CATEGORY IS -- WHEN IT
COMES TO ICHT RB IS RESEARCH
THAT HAS MORE THAN MINIMAL RISK
AND IF RESEARCH HAS MORE THAN
MINIMAL RISK THAT IS PHYSICAL OR
PSYCHOLOGICAL, ET CETERA, IT HAS
TO BE REVIEWED BY A FULL
COMMITTEE.
AND THAT INITIAL PROTOCOL THAT
YOU SUBMIT GOES THROUGH FIRST AN
INITIAL ADMINISTRATIVE REVIEW
AND THIS LITTLE DIAGRAM HERE IS
TO HIGHLIGHT THAT THE IRB IS
SEPARATE FROM THE ADMINISTRATIVE
STAFF STAFFING HUMAN RESEARCH
PROGRAM AND ARE REVIEWING
RESEARCH PLAN AND ANYTHING THAT
THE POTENTIAL SUBJECT WILL SEE
THAT INCLUDES CONSENT AND
ADVERTISEMENTS AND THEY
COORDINATE ALSO OTHER ANCILLARY
REVIEWS AND IF REVIEW OF
PHARMACEUTICALS OR REVIEW OF
RADIATION OR OF CONFLICT OF
INTEREST, THIS GROUP IS
COORDINATING THAT REVIEW THAT
WILL BE RELEVANT IN A SECOND.
RESEARCH GOES TO THE IRB AND
THEY DELIBERATE. AGAIN, THAT IS
THIS GREW OF EXPERTS AND THERE
ARE AT LEAST FIVE OF THEM AND
THEY CAN DO A COUPLE THINGS AND
APPROVE WITH STIPULATIONS AND
DEFER OR DISAPPROVE.
IN MY EXPERIENCE, IRBS ALMOST
NEVER DISAPPROVE.
PART OF THAT IS BECAUSE
INVESTIGATORS THESE DAYS KNOW
THAT THEIR RESEARCH HAS TO SORT
OF BE AT A PARTICULAR STANDARD
IN ORDER TO EVEN BE CONSIDERED.
SOME RESEARCH IS DEFERRED WHEN
THERE IS SORT OF A BIG PROBLEM
ON ITS WAY TO APPROVAL AND THEY
FORGOT TO TALK ABOUT HOW THEY
ARE RECRUITING THEIR SUBJECTS OR
FORGOT TO INCLUDE INFORMATION
ABOUT RISKS THAT THEY WILL
EXPOSE SUBJECTS TO.
APPROVE WITH STIPULATIONS MIGHT
BE SOMETHING AS STRAIGHT FORWARD
AS YOU ARE APPROVED AND YOU HAVE
TO EXCEPT REVISIONS WE MADE TO
YOUR CONSENT FORM AND STRAIGHT
UP APPROVAL IS ALSO VERY SELDOM
THE CASE.
WHEN I WAS AT SCHOOL OF PUBLIC
HEALTH AT JOHN'S HOPKINS YOU ARE
ALL TOO YOUNG TO PROBABLY
REMEMBER THIS BUT SCHOOL OF
MEDICINE AT JOHN'S HOPKINS WAS
CLOSED AND IRB SHUT DOWN AFTER A
HEALTHY VOLUNTEER DIED IN AN
ASTHMA STUDY AND ONE OF THE
THINGS THEY SAID OH, HRP WHO
CLOSED IT DOWN SAID IS YOU HAVE
TO REREVIEW ALL OF THE RESEARCH
ARE YOU CONDUCTING AND THOUSANDS
OF PROTOCOLS AND SUBSET OF THOSE
WERE BEING CONDUCTED BY SCHOOL
OF PUBLIC HEALTH FACULTY AND I
WAS ON THE GROUP THAT HAD TO --
THAT GOT TO REVIEW ALL THAT
RESEARCH AND THERE WERE MORE
THAN 50 PROTOCOLS AND WE
APPROVED ONE WITHOUT
STIPULATIONS AND ALL OTHERS HAD
SOME SORT OF STIPULATION WE
WANTED CHANGED AND ALL TO SAY
THAT MOST RESEARCH IS GOING TO
BE APPROVED WITH STIPULATIONS
AND THERE WILL BE SOMETHING THAT
THE IRB WILL WANT YOU TO DO.
THE OTHER THINGS THAT IRBS DO IS
THEY ARE IN CHARGE OF CONTINUING
REVIEW.
SO, FOR THOSE PROTOCOLS REVIEWED
BY A FULL COMMITTEE,
INVESTIGATORS HAVE TO COME BACK
TO THE IRB AND GIVE AN UPDATE.
IF YOU CHANGE YOUR STUDY AND THE
GENERAL RULE IS IF YOU WILL
CHANGE THE RISK BENEFIT
ASSESSMENT FOR THE SUBJECTS,
THEN YOU HAVE TO AMEND YOUR
STUDY.
FOR EXAMPLE, IF YOU ARE DOING --
IMAGINE YOU ARE DOING A STUDY
WHERE YOU HAVE -- YOUR PLAN IS
TO TAKE ONE BIOPSY FROM A COLON.
DURING A CLINICALLY INDICATED
COLONOSCOPY AND YOU REALIZE THAT
IS NOT ENOUGH AND YOU NEED A
SECOND SAMPLE.
THAT WOULD CLEARLY SHIFT THE
RISK BENEFIT BALANCE FOR THE
PARTICIPANTS.
YOU WOULD HAVE TO AMEND YOUR
STUDY.
AND SEND THAT TO THE IRB AND
THEY HAVE TO APPROVE IT BEFORE
YOU COULD ACTUALLY EXPOSE ANYONE
TO THAT SECOND BIOPSY.
I WANT TO SEND A MINUTE, 2 OR 3
MINUTES ON A PRESENT POLICY
ISSUE.
A NUMBER OF YEARS AGO BOTH THE
NIH AND HHS PUT IN POLICY THAT
SAID IF YOU ARE CONDUCTING
MULTISIELT RESEARCH IN THE
UNITED STATES YOU NEED OR CAN OR
NEED TO IDENTIFY A SINGLE IRB OF
RECORD.
BACK TO MY LITTLE DIAGRAM HERE,
BEFORE THE SINGLE IRB POLICY, IF
YOU ARE CONDUCTING A MULTICENTER
TRIAL AND HERE I HAVE FIVE SITES
AND COORDINATING CENTER. THIS
IS SORT OF, YOU KNOW, THIS IS
LIKE MANY TRIALS. IT IS LIKE AN
AVERAGE ONCOLOGY TRIAL OR
SOMETHING AND YOU HAVE A
COORDINATING CENTER AND FIVE
SITES RECREWING CANCER PATIENTS
INTO THE STUDY AND MEANT THAT
YOU WOULD HAVE ONE IRB REVIEW BY
THE COORDINATING CENTER AND FIVE
IRB REVIEWS THAT EACH OF THE
SITES WOULD DO ON AND IT ADDED
UP TO 6.
INVESTIGATORS DID NOT LIKE THIS
AT ALL.
IT CREATED DELAYS THAT MEANT
THAT THEY COULDN'T DO THEIR
RESEARCH AND IDENTIFY THE MOST
APPROPRIATE EFFECTIVE
INTERVENTION, ET CETERA.
SO IN RESPONSE, NIH AND HHS
DECIDED THAT THEY WOULD REQUIRE
THAT THERE BE A SINGLE IRB OF
RECORD.
NOW WHAT THIS MEANS IS THE
COORDINATING CENTER OR IRB OR
INSTITUTION DESIGNATED CONDUCTS
ONE IRB REVIEW AND FIVE
INDIVIDUAL SITES SAY TO THAT IRB
THAT WE WILL DO WHATEVER YOU
SAY.
YOUR APPROVAL WILL BE OUR
APPROVAL.
NOW, ONE CHALLENGE WITH THAT,
THAT I TRIED TO CONVEY WITH
LITTLE LINES IS THAT, THAT
DOESN'T RELIEVE THAT LOCAL
INSTITUTIONS FROM DOING ALL OF
THE OTHER REVIEWS AND CONFLICT
OF INTEREST AND RADIATION AND
PHARMACEUTICAL.
SO THE POLICY HAS BEEN IN PLACE
FOR A NUMBER OF YEARS NOW AND
ARE EVALUATIONS THAT ARE
UNDERWAY AND OUTCOMES ARE
UNCLEAR WHETHER IT IN FACT MAKES
THE SYSTEM MORE EFFICIENT.
AND THERE HAS BEEN A LOT OF WORK
IN DEVELOPING THINGS LIKE THE
SMART IRB WHICH IS A WAY THAT
INDIVIDUAL INSTITUTIONS CAN
LEARN ABOUT HOW TO BEST
COORDINATE WITH OTHER SITES.
SO, WE WILL SEE WHERE IT GOES
AND THAT IS A CURRENT ISSUE IN
IRB POLICY.
HERE IS MY SUMMARY SLIDE.
WHEN IN DOUBT ABOUT YOUR
RESEARCH, ASK YOUR LOCAL
COMMITTEE. THEY ARE THE BEST
SITUATED TO ANSWER ANY OF YOUR
QUESTIONS.
SO THAT IS IT FOR ME.
I AM NOW GOING TO TAKE QUESTIONS
FOR THE NEXT 20 MINUTES WHICH
MEANS I WILL GO OVER THERE AND
GET MY COMPUTER TO SEE IF ANYONE
OUT IN VIDEO LAND IS ASKING A
QUESTION.
FEEL FREE FOR THOSE HERE TO GO
TO THE MICROPHONES AND ASK
QUESTIONS.
GREAT. JONATHAN, GO AHEAD.
>> HI. THANKS, HOLLY, FOR
EVERYTHING.
I WAS WONDERING IF THERE HAS
BEEN ANY TALK OF USING AI
SOMEHOW IN IRBS ESPECIALLY TO
MAYBE EXPEDITE THINGS OR I DON'T
KNOW IF THERE IS ANYTHING THAT
AI COULD DO BUT.
>> SHORT ANSWER IS YES.
THERE IS A LOT OF CHATTER FOR
LACK OF A BETTER WORD AND OF
USING AI TO DO A VARIETY OF
THINGS AND HEARD THE TAIL END OF
A TALK THE OTHER DAY.
YOU WILL LEARN NEXT WEEK THAT
THERE IS A NEW REQUIREMENT AS IT
RELATES TO INFORMED CONSENT FORM
THAT AT THE VERY TOP OF THE FORM
THERE IS KEY INFORMATION THAT IS
THE MOST IMPORTANT INFORMATION
THAT THE POTENTIAL PARTICIPANT
SHOULD KNOW.
AND SO A GROUP AT THE UNIVERSITY
OF MICHIGAN HAS BASICALLY
CREATED A WAY WITH QUERIES TO
CHATGPT 4 OR 5 OR 6 TO SAY, HERE
IS THE CONCEPT FORM.
PLEASE PULL OUT THE KEY
INFORMATION AND PUT IT IN A
READABLE, YOU KNOW, EIGHTH GRADE
LANGUAGE AND THEY BETA TESTED
THAT FOR A WHILE AND HAVEN'T
ADOPTED IT AS A SERVICE FOR ALL
INVESTIGA
INVESTIGATORS.
THAT IS ONE WAY INVESTIGATORS
ARE USING IT TO SUPPLY WITH
REGULATIONS AND HAS BEEN CHATTER
ABOUT COULD YOU USE AI TO DO
THAT ADMINISTRATIVE REVIEW, FOR
EXAMPLE.
THIS IS THE PROTOCOL AND MAKE
SURE IT HAS ALL 7 COMPONENTS AND
THAT THERE IS SOMETHING THAT
MAKES SENSE BELOW.
THERE IS A LOT OF IDEAS AND IS
NOT YET ANY CHATTER ABOUT
REPLACING THE IRB WITH AI BUT
WHO KNOWS.
>> HI, DANIELLE.
>> HI. THIS IS SUPER
INTERESTING.
MY QUESTION IS ABOUT YOU
MENTIONED THAT IRBS VARY IN
TERMS OF PRACTICE AND POLICY
BESIDES BEING BEHOLDENED TO
FEDERAL REGULATIONS AND CURIOUS
HOW MUCH THEY VARY FROM
INSTITUTION TO INSTITUTION.
>> YEAH.
>> DO THEY LOOK VASTLY DIFFERENT
OR GENERALLY PRETTY SIMILAR?
>> GREAT QUESTION.
SHORT ANSWER IS IT IS A BIT OF A
BELL CURVE; RIGHT?
A REALLY GOOD EXAMPLE IS WHEN
YOU ARE DOING PEDIATRIC
RESEARCH, THE IRB MUST
CATEGORIZE RESEARCH AS NO MORE
THAN MINIMAL RISK OR MORE THAN
MINIMAL RISK WITH A PROSPECT OF
DIRECT BENEFIT AND MORE THAN
MINIMAL RISK AND POTENTIAL
BENEFIT TO THE GROUP OF CHILDREN
THAT ARE REPRESENTED BY THE
POPULATION THAT YOU ARE
ENROLLING.
SO THAT DEFINITION OF MINIMAL
RISK IS REALLY IMPORTANT AS IT
RELATES TO WHAT CATEGORY OF
RESEARCH IT IS.
IF THERE IS A LOT -- IF THERE IS
A LOT OF RISK, THERE HAS TO BE
DIRECT BENEFIT.
IN THE THIRD CATEGORY, YOU KNOW,
YOU HAVE TO BE ABLE TO SAY,
WELL, WHAT -- HOW MUCH RISK IS
TOO MUCH TO EXPOSE, ET CETERA?
SO SIMA SHAW A FELL FOE IN
DEPARTMENT OF BIOMEDICAL ETHICS
ASKED IRBS FOR PEDIATRIC
RESEARCH HOW DO YOU DEFINE
MINIMAL RISK?
THIS IS A LIST OF POTENTIAL
THINGS AND WHICH WOULD YOU CALL
MINIMAL RISK OR NOT?
BLOOD DRAW UP TO A LUMBAR
PUNCTURE OR TAKE AN AMOUNT OF
BLOOD; RIGHT?
SHE SORT OF SAID.
BOTTOM LINE THERE WAS LOTS OF
VARIATION AND IT WAS A BELL
CURVE AND SOME IRBS WOULD SAY
NONE OF THAT IS MINIMAL RISK AND
A SIMPLE BLOOD DRAW WHERE AT
OTHER END LUMBAR PUNCTURE, NO.
NOT AGAIN.
THAT IS A LITTLE EXTREME.
BUT YOU GET THE IDEA.
SO, IT IS WITHIN A BELL CURVE.
WE AS ETHICS TYPES MIGHT WORRY
ABOUT EITHER END; RIGHT?
WE MIGHT WORRY ABOUT EXPOSING
KIDS TO TOO MUCH RISK OR MIGHT
WORRY ABOUT VALUABLE RESEARCH
THAT IS NOT HAPPENING BECAUSE
THEY ARE SO STRICT.
THAT IS GENERALLY TRUE.
WHEN YOU LOOK AT THE LITERATURE
ABOUT IT IS NOT VERY WIDE BUT
THERE IS LITERATURE ABOUT HOW
IRBS HAVE SOME SAID EXEMPT AND
OTHERS SAID IT WAS EXPEDITED AND
BELL CURVE AND LITTLE ON EITHER
END.
GO AHEAD.
>> HI. I HAVE A QUESTION ABOUT
QUALITY CONTROL.
>> I IMAGINE A NUMBER OF LOCAL
IRBS AND A BUNCH OF DIFFERENT
PEOPLE SITTING ON COMMITTEES AND
PROCEDURE FOR IRBS TO SIT AND
STEP BACK AND LOOK AT ALL CASES
THAT THEY HAVE, YOU KNOW,
PRESIDING OVER AND LOOKED AT IN
THE PAST A NUMBER OF MONTHS.
>> YEAH.
>> AND MAKE DETERMINATION ABOUT
WHETHER THEIR DECISIONS HAVE
BEEN GENERALLY CONSISTENT?
>> YES.
THIS IS A TOPIC THAT IS VERY
CLOSE TO MY HEART AND SPEND A
LOT OF TIME THESE DAYS THINKING
ABOUT HOW WE CAN EVALUATE
QUALITY OF IRB REVIEW AND
OVERSIGHT.
SHORT ANSWER IS THERE ARE SOME
TOOLS THAT ARE INADEQUATE, I
WOULD SAY.
THAT AN IRB COULD STEP BACK AND
REVIEW OR LOOK AT.
HOW DID WE DEDECIDE TO LOOK AT
PEDIATRIC RESEARCH AND SEE HOW
WE DECIDED WHETHER OR NOT WE
SAID ALWAYS THAT A BLOOD DRAW
WAS MINIMAL RISK.
ONE COULD DO THAT AND IRBS ARE
BUSY AND DON'T HAVE ENOUGH STAFF
OR FUNDING AND FOR SOME IS A BIT
OF A LUXURY TO TAKE THAT STEP
BACK.
THERE ARE -- THERE IS A WUM OF
WAYS IN WHICH INSTITUTIONS
IMPROVE LIKELIHOOD THAT PEOPLE
AROUND THE TABLE ARE WELL
SITUATED AND THEY ARE ALL
TRAINED IN A PARTICULAR WAY AND
THEY HAVE IN-SERVICE TRAINING
AND I'M SURE IF A CHAIR HAD A
CONCERN YOU ARE ON IRB AND FELL
ASLEEP AND NEVER BROUGHT IN
REVIEWS IN AND THEY PROBABLY HAD
A CHAT WITH YOU ASKING YOU -- AT
THE EXTREMES; RIGHT?
THERE ARE WAYS THAT SORT OF
LOCAL QUALITY COULD BE
MAINTAINED AND ARE WAYS YOU
COULD STEP BACK AND SOME
INSTITUTIONS DO AD HOC AUDITS
NOT FOR CAUSE; RIGHT?
WE ARE NOT WORRIED ABOUT A
PARTICULAR PERSON'S PROTOCOL AND
YOU CAN'T REVIEW EVERYTHING AND
SAY I WILL RANDOMLY SELECT 10
PROJECTS TAKING A DEEP DIVE AND
AUDITS CAN INFORM, WOW.
EVERYBODY IS FORGETTING TO DO X
AND WE HAVE TO REORIENT
INVESTIGATORS AND IRBS TO MAKE
SURE THIS IS PRESENT.
>> GO AHEAD.
>> HI.
SALLY.
>> HI. MORE PRACTICAL QUESTION
ON SOMETHING YOU PUT UP.
>> YUP.
>> ABOUT IRBS AND
RESPONSIBILITIES AND YOU WROTE
THAT IRBS HAVE TO DO CONTINUING
REVIEWS.
>> YES.
>> ON STUDIES THAT RECEIVE FULL
COMMITTEE REVIEW.
>> YEAH. EXPEDITED REVIEWS THAT
ARE MINIMAL RISK.
>> YEAH.
>> ARE YOU SAYING -- THIS IS
GOOD IF YOU ARE, THAT THEY DON'T
NEED CONTINUING INTERVIEW AND
KNOW GO TO LOCAL.
>> GREAT QUESTION. ONE THING
NONE OF US MENTIONED TODAY IS
COMMON RULE IS REVISED IN 2018
AND AFTER A VERY LONG PROTRACTED
PROCESS AND ONE OF THE THINGS
THAT IS DIFFERENT FROM BEFORE
2018 IS THAT ONLY FULL COMMITTEE
REVIEWED PROTOCOLS ARE REQUIRED
TO PROVIDE AN ANNUAL REVIEW.
>> AH.
>> IF EXPEDITED YOU DON'T HAVE
TO.
NOW, SOME IRBS COULD SAY WE WANT
TO DO MORE THAN WHAT THE
REGULATIONS REQUIRE AND WE WANT
TO REVIEW ALL EXPEDITED
RESEARCH.
THERE ARE NO LONGER REQUIRED BY
FEDERAL REGULATIONS TO DO THAT.
>> GOTCHA.
>> WHEN THEY APPROVE, WHICHEVER
IRB YOU ARE IN, WHEN THEY
APPROVE OF YOUR STUDY, THEY WILL
TELL YOU.
>> EXACTLY.
>> WE WANT TO CONTINUE REVIEW
EVERY YEAR AND WANT TO KNOW WHAT
IS GOING ON.
>> EXACTLY. EXACTLY.
SOMETIMES.
>> IT IS NOT REQUIRED?
>> NOT REQUIRED.
SOME IRBS WILL DO A SHORTER
PERIOD AND HERE AT THE CLINICAL
CENTER AND WILL MENTION THIS IN
ANOTHER LECTURE.
THE VAST MAJORITY OF RESEARCH
THAT HAPPENS HERE IS PHASE 1
RESEARCH. VERY EARLY AND FIRST
IN HUMAN TRIALS.
WHEN THAT TYPE OF TRIAL IS GOING
ON THE IRB MIGHT SAY YOU KNOW
WHAT?
WE ARE WORRIED ABOUT THAT AND
WANT TO REALLY HAVE CLOSE -- WE
WANT TO BE VERY CAREFUL ABOUT
THE RISKS THAT PEOPLE ARE
EXPOSED TO AND WANT TO MAKE SURE
THAT EVERYTHING IS MOVING
FORWARD AND WE WANT TO REVIEW
YOU IN SIX MONTHS AND IRB ALWAYS
HAS THE OPTION TO ASK FOR
SOMETHING EARLIER IF THEY WANT
TO.
>> THANK YOU VERY MUCH.
>> GREAT. THAT IS THE END OF
OUR SESSION FOR TODAY. THANK
YOU ALL. SORRY, AGAIN, FOR THE
GLITCH IN THE VIDEO FOR ALL OF
YOU OUT THERE IN VIDEO LAND.
WE WILL BE BACK HERE NEXT
WEDNESDAY, SAME TIME AND SAME
LINK AND WE ARE FINGERS CROSSED
IT WILL WORK.
FEEL FREE TO SEND ME ANY
QUESTIONS AND PUT THEM ON THE
DISCUSSION BOARD. I WILL TRY TO
ANSWER