>>THANK YOU FOR JOINING US
FOR THE AUGUST SESSION FOR THE
EDUCATION SERIES. TODAY'S TITLE
MORE ETHICS OR MORE COMPLIANCE,
WHAT WAS DR. BEECHER TRYING TO
TELL US? THIS PRESENTATION WILL
BE ARCHIVED IN THE PAST SECTION
OF THE VIDEO CAST SITE AND A
LINK TO THE VIDEO CAST AS WELL
AS THE SLIDES FROM THE SESSION
WILL BE POSTED ON THE OHSRP
WEBSITE IN THE PRESENTATION
ARCHIVE SECTION OF THE OHSRP
TRAINING PAGE IN ABOUT ONE TO
TWO WEEKS. WE STRONGLY
ENCOURAGE VIEWERS TO SUBMIT
QUESTIONS THROUGHOUT THE SESSION
BY CLICKING ON THE BOX BELOW THE
VIDEO TITLED LIVE FEEDBACK LINK
AND NOW THE DIRECTOR JONATHAN
GREENE WILL INTRODUCE OUR
SPEAKER.
>>JONATHAN: THANKS, PEG I'M
THRILLED TO INTRODUCE TODAY'S
SPEAKER TO GIVE OUR SEMINAR
SERIES TODAY. I HAVE KNOWN
QUINCY FOR A NUMBER OF YEARS
NOW. HE'S A REALLY GREAT FRIEND
AND COLLEAGUE AND I'M JUST
THRILLED THAT HE'S AGREED TO
JOIN US TODAY. I AM GOING TO
GIVE A LITTLE BIT OF HIGHLIGHTS
FROM HIS BIO BUT IF I GO THROUGH
HIS WHOLE BIO WE WON'T HAVE TIME
FOR THE TALK. THE HIGH POINTS
OF DR. BYRD SONG IS CURRENTLY
THE VICE PRESIDENT AT VALID
HEALTH IN JOHNSON CITY,
TENNESSEE WHERE HE HAD
PROGRAMMATIC OVERSIGHT OF ALL
RESEARCH EFFORTS IN CONJUNCTION
WITH THE SYSTEM CHAIR FOR
CLINICAL RESEARCH. PRIOR TO
COMING TO BALLAD, DR. BYRD SONG
SERVED AS THE VICE PROVOST OF
PUBLIC AFFAIRS IN NASHVILLE,
TENNESSEE WHERE HE HAD A NUMBER
OF ROLES OVERSEEING THE RESEARCH
ENTERPRISE AND EDUCATIONAL
ACTIVITIES. HE AND I BOTH SERVE
ON THE BOARD OF DIRECTORS SO A
HARP IS THE ORGANIZATION THAT
ACCREDITS RESEARCH PROTECTION
PROGRAMS WHERE HE'S JUST A
REALLY AMAZING COLLEAGUE AND
CONTRIBUTOR. AND THE ONE THING
I HAVE REALLY LEARNED FROM --
I'VE LEARNED MANY THINGS FROM
BEING WITH QUINCY BUT THE MOST
IMPORTANT THING I'VE LEARNED IS
WHEN HE SPEAKS IT'S TIME TO STOP
AND LISTEN. AND NOT JUST STOP
AND LISTEN AND PAUSE BUT REALLY
THINK ABOUT IT BECAUSE WHEN
QUINCY SPEAKS INEVITABLY IT'S
SOMETHING REALLY IMPORTANT THAT
I NEED TO HEAR AND THINK ABOUT.
AND I AM SURE THAT WILL BE THE
CASE WITH HIS PRESENTATION TODAY
SO AGAIN, QUINCY, THANK YOU SO
MUCH FOR SPEAKING TODAY.
>>QUINCY: THANK YOU, JONATHAN
AND THANK YOU, PEG FOR ARRANGING
ME TO SPEAK WITH THIS AUDIENCE.
BY WAY OF BACKGROUND
ABOUT ME YOU'VE HEARD JONATHAN
MENTION A FEW POINTS FROM MY
BACKGROUND BUT I THINK IT'S
IMPORTANT FOR YOU TO UNDERSTAND
THE LENS FROM WHICH I AM GIVING
THIS TALK. MY FIRST JOB IN
HEALTH CARE WAS THE DIRECTOR OF
AN IRB FOR A STANDALONE MEDICAL
SCHOOL AND THE OPPORTUNITY TO
PROTECT HUMAN RESEARCH
PARTICIPANTS WAS SOMETHING I
FOUND TO BE OVERWHELMING AND
HUMBLING AND REWARDING AND I
THOUGHT OF ALL THE ETHICAL WAYS
THAT RESEARCH CAN BE DONE WHEN
IT INVOLVED HUMAN BEINGS BUT
AFTER I TOOK THIS JOB, I WAS
GIVEN A REAM OF REGULATIONS,
PAGES AND PAGES OF REGULATIONS
FROM MY BOSS AND I THOUGHT TO
MYSELF, WOW, I THOUGHT THIS WAS
THE JOB THAT LOOKED AT THE
ETHICS OF RESEARCH. INSTEAD IT
TURNS OUT THAT THIS IS A JOB
THAT LOOKS AT HOW WELL RESEARCH
FOLLOW ASSET OF RULES THEN I
BEGAN TO THINK TO MYSELF ARE
THOSE TWO NECESSARILY MUTUALLY
EXCLUSIVE. CAN RESEARCH
INVOLVING HUMAN BEINGS BE DONE
WITH AN ETHICAL REVIEW AND ALSO
WITH A REVIEW THAT LOOKS MORE AT
ALIGNMENT OF RESEARCH ACTIVITIES
WITH A SET OF EXPECTATIONS AND A
SET OF RULES? HENCE THIS TALK
TODAY. MORE ETHICS OR MORE
COMPLIANCE. AND WHAT WE'RE
GOING TO USE IS SORT OF THE
FOUNDATION FOR THIS DISCUSSION
IS AN ARTICLE BY DR. HENRY
BEECHER MOST OF YOU HAVE READ
THIS ARTICLE, ETHICS AND
RESEARCH IN THE NEW ENGLAND
JOURNAL OF MEDICINE, 1966 AND
THAT ARTICLE TALKED ABOUT ETHICS
FROM THE STANDPOINT IN THAT
THERE IS A WAY TO MAKE GOOD
DECISIONS AROUND THE RESEARCH
THAT WE CONDUCT AND AT THE SAME
TIME, FOLLOW A SET OF
EXPECTATIONS WHETHER WRITTEN OR
MORE INFORMAL IN NATURE. SO
WHAT WE'RE GOING TO TRY TO COVER
OVER THE NEXT 40 MINUTES OR SO,
WE'RE GOING TO LOOK AT THAT
ARTICLE AGAIN. THE ETHICS AND
CLINICAL RESEARCH ARTICLE BY
DR. HENRY BEECHER. WE'RE GOING
TO LOOK AT SOME QUESTIONS AROUND
THAT EXPOSE. SOME OF THOSE
QUESTIONS ARE GOING TO BE
IMPORTANT FOR US TO ANSWER AS WE
DIVE INTO THOSE ETHICS AND
COMPLIANCE AND LASTLY IDENTIFY
SOME HISTORICAL LESSONS WE
LEARNED FROM THE BEECHER ARTICLE
AND HOW THEY IMPACT WHAT WE DO
PARTICULARLY IN THE CLINICAL
TRIAL ENTERPRISE. SO, AS MANY
OF YOU KNOW ACADEMIC MEDICINE IN
THE WAY THAT IT'S CONDUCTED AND
CARRY OUT TODAY, IT REALLY
STARTED IN GERMANY. AND GERMANY
WAS THE MODEL FOR HOW MEDICAL
SCHOOLS WOULD CARRY OUT ITS
ACTIVITY, JOHNS HOPKINS
PATTERNED HIS MEDICAL SCHOOL
AFTER THINGS THEY SAW IN GERMANY
SO GERMANY BECAME A SEAT FOR
ACADEMIC MEDICINE WOULD BE
CREATED, THE HUB WHERE ACADEMIC
MEDICINE WOULD GROW AND THE
ENVIRONMENT WHERE IT WOULD
FLOURISH AND RESEARCH BACK IN
THE DAY WAS DONE ON HUMAN BEINGS
AND THE MINISTER OF ININTERIOR
ESTABLISHED A SET OF GUIDELINES
KNOWING A LOT OF RESEARCH WOULD
BE CONDUCTED BY THIS ACADEMIC
MEDICAL FACULTY AND BY
PHYSICIANS AND A SET OF
GUIDELINES WERE DEVELOPED AND
THEY WERE THREEFOLD AND THIS IS
AN ABBREVIATED VERSION OF THE
ENTIRE SET OF GUIDELINES BUT
ESSENTIALLY THE GUIDELINES STATE
THAT HAD THE GOAL OF THE
RESEARCH MUST BE THERAPY.
THAT INFORMED CONSENT SHOULD BE
OBTAINED AND DOCUMENTED AND
RURAL POPULATIONS SHOULD BE
PROTECTED. SO WHEN YOU THINK
ABOUT COMPLIANCE, YOU THINK
ABOUT RULES, YOU THINK ABOUT
REGULATIONS WE HAVE A SET OF
RULES HERE THAT GOVERN HOW HUMAN
RESEARCH IS DONE IN A POPULATION
WHERE A LOT OF RESEARCH ON HUMAN
BEINGS HAPPEN TO BE CONDUCTED.
BUT UNFORTUNATELY GERMANY WAS
ALSO THE PLACE OF OUR FIRST
DOCUMENTED AND ARGUABLY ONE OF
THE MOST EGREESHOUS EPISODES IN
UNETHICAL RESEARCH INVOLVING
HUMAN BEINGS WE'VE P EVER SEEN.
IN 1933 THE NAZI REGIME
ESTABLISHED THESE CONCENTRATION
CAMPS AND MANY OF YOU KNOW THEY
WERE DESIGNED TO TORTURE, WERE
DESIGNED TO MISTREAT, WERE
DESIGNED TO DESTROY WHAT THE
NAZI REGIME REGARDED AS AN
INFERIOR GROUP OF INDIVIDUALS.
SO THE GOAL WAS TWOFOLD, RIGHT,
TO PROMOTE THE SO-CALLED PERFECT
ARIAN RACE AND THE SECOND PART
WAS TO ELIMINATE ANYONE THAT WAS
NOT PART OF THAT SO-CALLED
PERFECT ARIAN RACE THREE
CATEGORIES OF THESE RESEARCH
PROJECTS, ONE WAS THE SURVIVAL
OF AXIS PERSONNEL. SO IT WAS
DESIGNED TO HELP INDIVIDUALS
FROM ITALY MALY SHA, GERMAN
MILITIA, JAPANESE MILITIA AND
THERE WERE SPECIFIC THINGS THEY
THOUGHT WOULD BE ENCOUNTERED BY
THESE MILITARY PERSONNEL,
FREEZING EXPERIMENTS, WHERE THEY
WOULD EXPOSE PRISONER TO REALLY,
REALLY LOW TEMPERATURES AND SEE
HOW LONG IT WOULD TAKE THEIR
BODY TO GO INTO HYPOTHERMIA.
HOW LONG THEY COULD LIVE OFF OF
SEAWATER. AND THE SECOND
CATEGORY WAS DRUG AND TREATMENT
TRIALS. THEY WOULD EXPOSE THESE
PRISONERS TO GASES AND OTHER
TYPES OF SITUATIONS AND THEN
TEST ANTIDOTES FOR THEM BUT AT
THE END OF THOSE TRIALS THE
INDIVIDUALS WOULD BE CARTED OFF
TO A GAS CHAMBER AND KILLED AND
THEN LASTLY THE CATEGORY OF AS I
MENTIONED BEFORE THE RACIAL
IDEOLOGICAL TENETS OF THE NAZI
WORLD VIEW AT THE TIME SO THEY
DID STUDIES ON JEWISH TWINS AND
WHAT THEY REFERRED TO AS
GYPSIES, INDIVIDUALS FROM
NORTHERN INDIA AND THEY HAD
STUDIES TO ESTABLISH IS THE WORD
THEY USED JEWISH RACIAL
INFERIORITY. SO THE JEWISH
WOULD BE IN THESE EXPERIMENTS,
WOULD DIE AND THE RESEARCHER
WOULD SAY, HEY, LOOK, THEY ARE
INFERIOR BECAUSE LOOK AT WHAT
HAPPENED TO THEM IN THIS
EXPERIMENT AND THEN LASTLY MASS
STERILIZATION. THIS WAS GOING
ON IN GERMANY EVEN IN THE
PRESENCE OF A SET OF GUIDELINES
THAT SAID THAT INDIVIDUALS THAT
PARTICIPATED AND SUBJECT
RESEARCH SHOULD BE PROTECTED.
SO THERE SEEMS TO BE A LITTLE
BIT OF DISCONNECT FROM THIS VERY
FIRST EPISODE. LET'S TAKE A
DEEPER DIVE. WERE THE NAZI
CONCENTRATION CAMP EXPERIMENTS
DUE TO A LACK OF KNOWLEDGE OR
WERE THEY DUE TO A LACK OF
ETHICS? SO LET'S LOOK AT THAT.
ARISTOTLE WHO WAS THE FATHER OF
MODERN DAY ETHICS IF YOU WILL
SAID THERE'S A DIFFERENCE
BETWEEN GOODNESS OF INTELLECT
AND GOODNESS OF CHARACTER.
THEY'RE SIMILAR IN THAT BOTH ARE
ADMIRABLE. GOOD IS GOOD.
PRAISE WORTHINESS AND PRAISE
WORTHINESS BUT THE DIFFERENCE IS
ONE IS THE KNOWLEDGE OF THE
RULES. THE OTHER IS THE
OBEDIENCE TO THOSE RULES. ONE
COMES FROM STUDYING AND THE
OTHER COMES FROM DISCIPLINE. SO
ARISTOTLE IS CERTAIN THAT ETHICS
COMES FROM NOT JUST GOOD AND BAD
BUT COMES WITH THE CARRYING OUT
OR THE PRACTICE OF DOING THE
RIGHT THING, NOT JUST THE
PRINCIPLE OF DOING THE RIGHT
THING. SO WHAT IS ETHICS? WHAT
ARE WE REALLY TALKING ABOUT WHEN
WE TALK ABOUT ETHICS? TODAY
WE'RE GOING TO COMPARE ETHICS
AND COMPLIANCE AND TALK ABOUT
THE POTENTIAL CONVERGENCE
BETWEEN THE TWO. WHAT IS IT
THAT WE'RE REALLY TALKING ABOUT?
THE BRANCH OF PHILOSOPHY THAT
DEALS WITH VALUES. RELATED TO
HUMAN CONDUCT, RESPECT TO RIGHT
AND WRONG, RESPECT TO GOOD AND
BAD AND ALSO THE KNOW -- KNOW
DISAND THE ENDS OF THESE
ACTIONS.
IT DOESN'T MAKE A DIFFERENCE IF
THE PERSON THAT DID THE WRONG IS
GOOD OR IF THE PERSON THAT WAS
WRONGED IS BAD OR IF THE BAD MAN
WRONGED THE GOODMAN ARISTOTLE
SAID IT DOESN'T MATTER.
THE LAN LAW CAN ONLY LOOK AT THE
DAMAGE THAT WAS DONE.
SO LET'S TAKE THAT BACK TO WHAT
WE MENTIONED AT THE
CONCENTRATION CAMPS. SO WHEN
WOE LOOK AT THE WRONG THAT WAS
DONE YOU HAVE THE PERMISSIBLE
MEDICAL EXPERIMENTS WHICH IS ONE
OF THE WAYS THAT YOU CAN LOOK
THIS UP. ALSO THE UNITED STATES
OF AMERICA VERSUS KARL BRANDTH.
YOU CAN LOOK UP ALL OF -- AT
LEAST SOME OF THE SCENES ABOUT
THOSE TWO SEARCHED TERMS. THERE
ARE 23 DEFENDANTS. 16 WERE
FOUND GUILTY AND OF THESE 16,
THE MAJORITY OF THEM WERE
EXECUTED. FOR THEIR CRIMES. IT
WAS PART OF THE VERDICT OF A
MURDER TRIAL. THESE INDIVIDUALS
WERE NOT ON TRIAL FOR BEING
UNETHICAL RESEARCHERS. THEY
WERE ON TRIAL FOR MURDER. THE
RESPONSE TO THE TRIAL WAS THE
NUREMBERG CODE. THIS CODE
BECAME THE OFFICIAL RESPONSE IN
TERMS OF GUIDELINES, AND THEY
ESTABLISHED INFORMED CONSENT,
THE REQUIREMENTS FOR ABSENCE OF
COERCION OR THE REQUIREMENTS
AROUND RESEARCH DESIGN AND THE
REQUIREMENT AROUND THIS HAS TO
BE AROUND THE GOOD, PARTICULARLY
NOT JUST THE GOOD OF THE SUBJECT
BUT THE GREATER GOOD OF MANKIND,
HUMANKIND. DR. ANDREW IVY WAS
PRESENT AT THESE MEETINGS AND
REPRESENTED THE AMERICAN MEDICAL
ASSOCIATION DURING THE DOCTORS'
TRIAL. WE HAVE GUIDELINES, WE
HAVE UNETHICAL RESEARCH. THEN
WE HAVE RESPONSE, THIS NUREMBERG
CODE. SO WE'RE SEEING
REGULATIONS BEING CREATED IN THE
ABSENCE OF ETHICS. WE'RE
STARTING TO SEE THIS CONVERGENCE
SEEPING IN EVEN EARLY ON IN THE
HISTORY OF HUMAN
EXPERIMENTATION. SO AS WE LOOK
A LITTLE FURTHER, THE QUESTION
OF COMPLIANCE COMES INTO THIS
CONVERSATION. SO WHERE ARE THE
NAZI CONCENTRATION CAMP SET OF
EXPERIMENTS AND EXAMPLE OF
NONCOMPLIANCE SINCE THE NUR REM
BURG CODE WAS WRITTEN AFTER THE
EXPERIMENTS WERE CONDUCTED?
WELL, ARISTOTLE SAYS THAT HE'S
GAINED FROM PHILOSOPHY THAT HE
DOES WITHOUT BEING COMMANDED
WHAT OTHERS DO ONLY FROM THE
FEAR OF THE LAW. AT A CERTAIN
POINT, THERE'S CERTAIN THINGS
THAT YOU JUST SHOULDN'T DO EVEN
IF THERE'S NOT A LAW THAT
PROHIBITS IT. AND THAT'S SORT
OF WHAT WE'RE LOOKING AT WITH
THE NAZI CONCENTRATION CAMP
EXPERIMENTS SO WHAT IS
COMPLIANCE THEN? WE TALKED
ABOUT ETHICS AS RIGHT AND WRONG.
WHAT IS COMPLIANCE? WELL,
COMPLIANCE IS SIMPLY THE ACTION
OF COMPLYING WITH THE RULE OR
REQUEST. NOW THERE ARE A LOT OF
RULES, ORDERS, REGULATIONS THAT
GOVERN WHAT WE DO IN RESEARCH
INVOLVING HUMAN BEINGS. SO
COMPLIANCE TALKS ABOUT THE ACT
OF FOLLOWING THOSE RULES AND OUR
WORK. SO WE TALKED ABOUT ETHICS
A FEW MINUTES AGO. WHICH IS THE
RIGHT OR WRONG ABOUT HOW WE
INTERACT WITH HUMANS THAT ARE
INVOLVED IN RESEARCH. NOW WE'RE
TALKING ABOUT THE ACT OF
FOLLOWING RULES THAT GOVN --
GOVERN RESEARCH. SUBTLETIES IN
BOTH OF THOSE BUT I THINK THE
DIFFERENCES ARE BIG ENOUGH TO
TAKE A DEEPER DIVE. IN
ARISTOTLE WE TALK A LITTLE BIT
ABOUT COMPLIANCE THIS IS WHERE I
HAVE AN OPPORTUNITY TO ACCUSE
ARISTOTLE OF DOUBLE TALK, THIS
IS THE TIME I WOULD DO IT. HE
SAYS HE DOES WHAT IS RIGHT
WITHOUT THE FEAR OF THE LAW.
NOW HE GOES ONTO SAY, EVEN THE
BEST OF MEN IN AUTHORITY ARE
LIABLE TO BE CORRUPTED BY
PASSION. SO THEN WE MAY
CONCLUDE THEN THAT THE LAW IS
REASON WITHOUT PASSION. AND IT
IS THEREFORE PREFERABLE TO ANY
INDIVIDUAL. OKAY. SO ABOUT
PHILOSOPHY HE DOES WHAT OTHERS
DO WITH FEAR OF THE LAW BUT SAYS
THE LAW IS PREFERABLE BECAUSE IT
ALLOWS YOU TO HAVE REASON
WITHOUT THE INFLUENCE OF
PASSION. SO AT SOME POINT, WE
HAVE TO THINK ABOUT WHAT IS IT
THAT WE NEED TO PRIORITIZE? OR
IF WE DON'T NEED TO PRIORITIZE
EITHER, OR WE NEED TO FIND
SOMEWAY TO PULL BOTH OF THESE
SORT OF COMPETING THINGS OR AT
LEAST ON THE SURFACE, SEEMINGLY
COMPETING THINGS INTO ONE
GENERALIZABLE THOUGHT. SO LET'S
TURN OUR ATTENTION TO BEECHER.
THIS ARTICLE MANY OF YOU HAVE
READ AND AN ARTICLE I READ OFTEN
TO REFOCUS ME ON WHAT IT IS THAT
IS IMPORTANT TO OUR WORK. HE
WAS A WORLD WAR II PHYSICIAN AND
STUDIED THE NAZI MEDICAL
EXPERIMENTS. HE STUDIED THEM
FOR WHAT THE EXPERIMENTS WERE
DESIGNED TO ACCOMPLISH BUT ALSO
STUDIED THE HORRENDOUS THINKING
BEHIND HUMAN EXPERIMENTATION
THAT WAS DONE IN THE WAY THAT IT
WAS DONE IN NAZI GERMANY AND
DURING THE 50S AND 60S HE BECAME
THE FORERUNNER IN THIS
CONVERSATION ABOUT RUTHLESS
ETHICS AND HE SUSPECTED THAT
PEOPLE IN THE UNITED STATES WERE
KILLED FOR SOME OF THE SAME
THINGS THAT THE NAZI REGIME WERE
GUILTY OF IN NUREMBERG. HE
WROTE THE ARTICLE IN JUNE OF
1966 AND THE ARTICLE SUMMARIZED
22 EXAMPLES OF UNETHICAL HUMAN
SUBJECTS RESEARCH. SO OUR FIRST
QUESTION WE'LL LOOK AT, SO HE
PUBLISHED 22 EXAMPLES IN THIS
EXPOSE. DOCTOR DR. BEECHER ONLY
FIND 22? TURNS OUT THAT
BEECHER'S INITIAL REVIEW WAS
BASED ON 17 STUDIES HE FOUND TO
BE UNETHICAL.
WHEN HE DID REFERENCING HE FOUND
REFERENCES IN THESE 17 THAT LED
HIM TO 50 ADDITIONAL UNETHICAL
STUDIES. WHEN REFERENCING THESE
HE FOUND AN ADDITIONAL 186
POTENTIAL. SO YOU SEE HOW THIS
COULD HAVE CONTINUED TO
SNOWBALL. SO ALTHOUGH HE ONLY
PUBLISHED 22 EXAMPLES, THERE
WERE REFERENCES IN THESE 22 THAT
LED TO POTENTIALLY CLOSE TO 200
AND MAYBE EVEN MORE. SO THIS
WAS SOMETHING THAT AT LEAST IN
THE EYES OF BEECHER WAS NOT
ISOLATED IN AND IT WAS A LOT
MORE PERVASIVE THAN HE HAD
ORIGINALLY THOUGHT. SO WHO DID
DR. BEECH EVERY CALL OUT IN
THESE EXPERIMENTS? THAT WOULD
HAVE WOULD HAVE BEEN THE THING
THAT REALLY MADE THIS JARRING TO
THE MEDICAL COMMUNITY. WELL IT
TURNED OUT HOE DIDN'T MENTION
ANY OF THE INVESTIGATORS OR
INSTITUTIONS. IN FACT THE
ARTICLE ONLY HAD FIVE
REFERENCES. FOUR OF THEM
WEREN'T EVEN FROM THE UNITED
STATES. AND ONE REFERENCE WAS
ACTUALLY AN ARTICLE THAT HE HAD
PREVIOUSLY WRITTEN ABOUT THIS
RESEARCH ETHICS. HIS ARTICLE
WAS NOT TO CALL OUT INDIVIDUALS
OR INSTITUTIONS BUT TO CALL OUT
THE ENTIRE INDUSTRY OF RESEARCH
INVOLVING HUMAN BEINGS. SO WAS
BEECHER JUST THIS ETHICAL
RESEARCH AND HAD A STELLAR
RECORD THAT MOTIVATED HIM TO DO
THIS AND ORIGINALLY THAT'S WHAT
I THOUGHT BUT IT TURNS OUT THAT
WAS ACTUALLY THE OPPOSITE. HE
CONDUCTED A STUDY IN 1948 THAT
DID NOT HAVE BY HIS OWN
ADMISSION DID NOT HAVE ADEQUATE
INFORMED CONSENT SO WHAT BEECHER
REALIZED WAS, SOMEONE THAT
ACTUALLY CONSIDERED THEMSELVES
TO BE AN ETHICAL AND CONSCIOUS
RESEARCHER HAD A SITUATION IN
HIS OWN LAB WHERE ETHICS WERE
COMPROMISED IN THE INTEREST OF
SCIENCE UNBEKNOWNST TO HIM. SO
THESE ARE SOME OF THE EXAMPLES
THAT WERE HIGHLIGHTED IN THE
ARTICLE. TREATMENT WAS
WITHHELD. THERE WERE STUDIES
WHERE THE TREATMENT SIDE EFFECTS
WERE LOOKED AT. SO TREATMENT
WOULD BE GIVEN JUST TO SEE IF
THE SIDE EFFECTS WOULD HARM THEM
AND TO THE DEGREE THAT IT WOULD
HARM THEM SO SOME OF THESE
STUDIES WERE DONE WHERE YOU KNEW
THE TREATMENT WOULD HAVE SIDE
EFFECTS SO YOU GAVE MORE OF THE
TREATMENT IN ORDER TO SEE IF IT
WOULD INCREASE THE SIDE EFFECTS.
THERE WERE STUDIES WHERE
DISEASES WERE ACTUALLY INJECTED
INTO INDIVIDUALS, WILLOWBROOK
WITH HEPATITIS. THERE WERE ALSO
STUDIES WHERE INJECTING
SOMETHING TO TRIGGER THE DISEASE
AND THERE WERE STUDIES WITH
ANESTHESIA WHERE IT WAS GIVEN TO
CAUSE HEART ATTACKS AND THEN YOU
HAD DELIBERATE STIMULATION ON
ORGANS AND TISSUES. SO THERE
WERE DICEY STUDIES THAT WERE
BROUGHT OUT AND MENTIONED IN
THIS ARTICLE AND THESE ARE SOME
SPECIFIC ARTICLES. THERE'S
PLACEBO-CONTROLLED STUDIES OF
STREP THROAT EVEN THOUGH
PENICILLIN WAS GIVEN TO CURE AND
TREAT STREP THROAT. TYPHOID
FEVER INDIVIDUALS WERE FOLLOWED
TO SEE WHAT WOULD HAPPEN IF YOU
DIDN'T TREATMENT. THERE WERE
ACNE STUDIES GIVEN TO THE TERM
THEY WERE GIVEN AT THE TIME
MENTALLY RETARDED JUVENILE
DELINQUENT AND THIS IS THE
LANGUAGE DIRECTLY FROM THE
ARTICLE AND THESE INDIVIDUALS
ARE VULNERABLE FOR MANY REASONS
AND WERE GIVEN TEST ARTICLES
THAT WERE NOT REALLY FOR ACNE
BUT THAT WAS THE ONLY THING THAT
THESE INDIVIDUALS HAD IN COMMON
AND THEN THESE OTHER STUDIES
THAT I MENTIONED BEFORE. SO
THIS ARTICLE TALKED ABOUT SOME
OF THE THINGS THAT MAKE US THE
MOST NERVOUS ABOUT RESEARCH. IN
HUMAN BEINGS. THIS WAS VERY,
VERY ALARMING. SUBJECT ASSIGN
ME
ASSIGNMENT WERE EXPOSED TO RISK
UNNECESSARILY. AND THEN THE BIG
ONE T LACK OF ADEQUATE INFORMED
CONSENT.
SO THIS ARTICLE BROUGHT UP ALL
THESE THINGS WE KNOW TO BE
UNETHICAL IN OUR WORK IN DOING
RESEARCH INVOLVING HUMAN BEINGS.
ALL RIGHT. SO THE ARTICLE WAS
ABOUT ETHICS. OKAY, BEECHER,
WHAT ABOUT COMPLIANCE? WHERE
DOES COMPLIANCE FIT INTO ALL OF
THIS? WHERE DO THE RULES FIT
IN? WHERE DO THE REGULATIONS
FIT IN? WHERE DO THE ORDERS FIT
INTO THIS CONVERSATION? BECAUSE
THE UNETHICAL RESEARCH THAT'S
BEING DONE IS HIGHLIGHTED BY
BEECHER AS AN EXPOSE SO HOW DOES
COMPLIANCE TAP INTO THIS
CONVERSATION?
WELL, IT TURNS OUT THAT THE
RESPONSE TO THE BEECHER ARTICLE
WERE SUBSTANTIAL. 1966 YOU HAVE
THE U.S. SURGEON GENERAL POLICY
STATEMENT. ALL SUBJECTS TO
REVIEW THE INDEPENDENT
PROSPECTIVE REVIEW. INFORMED
CONSENT. NATIONAL RESEARCH ACT.
PUBLIC LAW 93-348, FIRST SET OF
OVERARCHING REGS. THE BELMONT
REPORT. THE FIRST SET OF
REGULATIONS TO ESTABLISH THE
RULE SO THE RESPONSE TO BEECHER
WHICH BROUGHT OUT UNETHICAL
EXAMPLES OF RESEARCH. THE
RESPONSE WAS LET'S PROVIDE SOME
RULES THAT GOVERN THE RESEARCH.
SO NOW WE HAVE UNETHICAL
RESEARCH RESPONDED TO BY MORE
REGULATIONS AND MORE COMPLIANCE.
SO, WAS THAT THE PURPOSE OF
BEECHER'S ARTICLE TO ENCOURAGE
THE CLINICAL RESEARCH REGIME IN
PARTICULAR TO INCREASE
REGULATION AND OVERSIGHT? WELL,
IT TURNS OUT, THAT THAT WOULD BE
ANSWERED BY HOW ALL OF THIS
PLAYED OUT BEFORE THE ARTICLE
AND AFTER. SO LET'S LOOK AT
BEFORE THE REGULATIONS. SO
LET'S LOOK AT WHAT HAPPENED AT
NUREMBERG AND THE ETHICAL
CONSIDERATIONS THAT HAPPENED IN
THE CONCENTRATION CAMPS. WAS
THIS MEDICAL NECESSITY?
SCIENTIFIC MERIT? BENEFITTED
THE AXIS PERSONNEL AND THE
JUSTIFICATION OF ARYAN
SUPREMACY. THERE WAS NO
SCIENTIFIC MERIT THAT HAD MERIT
TO ALL OF SCIENCE. AND
DEFINITELY NOT MEDICAL NECESSITY
FOR INDIVIDUALS THAT WOULD BE
PART OF THIS AUTONOMY. OF
COURSE THERE WAS NONE. EVERYONE
IN THESE EXPERIMENTS WERE
PRISONERS, THEY HAD NO RIGHTS AT
HUMAN BEINGS AND THEY WERE
TREATED AND INTERACTED WITH AS
SUCH. THE CONCEPT OF DOING NO
HARM, WELL, OF COURSE, HARM WAS
DONE. ALL THE RESEARCH SUBJECTS
WERE SEVERELY INJURED OR
MURDERED. NOBODY GOT OUT OF
THESE CONCENTRATION CAMPS UP
SCATHED SO THE CONCEPT OF
ETHICAL PRINCIPLE WAS VIOLATED
WITH IMPUNITY. DO GOOD? WELL,
THERE'S NO GOOD DONE HERE. NONE
OF THE EXPERIMENTS HAVE ANY
PROSPECT FOR SUBJECT OR GREATER
GOOD BENEFIT IT WAS TO BENEFIT A
CERTAIN GROUP OF PEOPLE AND TO
BENEFIT A NOTION FROM A CERTAIN
STANCE THAT WAS DEFINITELY
COMING FROM A STANCE OF
SUPREMACY AND A STANCE OF
ESTABLISHING INFERIORITY OF
OTHERS AND LASTLY JUSTICE. OF
COURSE THERE WAS NO JUSTICE
HERE. ONLY USED THE PRISON --
PRISONERS AND THEY TOOK ON ALL
THE RISK AND NONE OF THE
BENEFIT. THERE'S ANOTHER
INSTANCE THAT WE PROBABLY NEED
TO LOOK AT THAT OCCURRED PRIOR
TO THE BEECHER ARTICLE AND THEN
EXTENDED A LITTLE BIT AFTER THE
BEECHER ARTICLE WAS WRITTEN.
AND THAT IS THE STUDY OF
UNTREATED SYPHILIS IN THE NEGRO
MALES. SINCE THEN IT WAS UP
UPDATED TO THE REFERENCE OF THE
INVOLVEMENT OF THE PUBLIC HEALTH
SERVICE AND KNOWN AS THE U.S.
PUBLIC HEALTH STUDY OF UNTREATED
SYPHILIS AND THIS WAS A STUDY
DONE BY A GROUP OF RESEARCHERS
THAT HAD PREVIOUSLY INTERACTED
WITH A COMMUNITY THAT WAS -- HAD
VERY HIGH INCIDENCE OF SYPHILIS,
40%. AND ONCE THEY RAN OUT OF
MONEY TO GIVE TREATMENT THEY
CAME BACK UNDER THE GUISE THAT
THEY WERE CONTINUES TO TREAT
THEM BUT THEY WERE ACTUALLY
FOLLOWING THEM UNTREATED.
AND THEY NEVER TOLD THE
INDIVIDUALS THAT THEIR PURPOSE
THERE HAD SHIFTED FROM TRYING TO
TREAT THEM TO NOW WATCHING THEM
UNTREATED. THE MINDSET DURING
THIS TIME THE DOCTOR ROW
REFLECTED THIS HE SAID THE
SITUATION WAS IF YOU WERE SICK,
AND YOU WERE A BLACK AMERICAN
DURING THIS TIME, THE SCIENTIFIC
COMMUNITY THOUGHT YOU WERE
BETTER OFF SERVING THE
SCIENTIFIC COMMUNITY AS SUBJECTS
AND PARTICIPANTS AND RESEARCH
EXPERIMENTS.
SO EVEN THE MINDSET AROUND THIS
WAS ONE OF LESS IMPORTANCE WAS
ASSIGNED TO THIS POPULATION AND
THIS RESEARCH WAS CONDUCTED IN A
WAY THAT THAT LACK OF IMPORTANCE
WAS EVIDENT THROUGHOUT THE
ENTIRE STUDY. BUT LET'S LOOK AT
THAT FROM A SCIENTIFIC
STANDPOINT AND AN ETHICAL
STANDPOINT. SO MEDICAL
NECESSITY. THERE WAS MEDICAL
NECESSITY FOR THIS STUDY. IN
THE FACT THAT THERE NEEDED TO BE
A RACIAL COMPARE TEAR, UNED
SYPHILIS HAS BEEN LOOKED AT IN
WHITE MALES AND HAD MORE
NEUROLOGICAL SIDE EFFECTS
WHEREAS BLACK MALES SHOW MORE
CARDIAC EVENTS AND THEN ALSO IT
WAS -- THERE WAS SCIENTIFIC
MERIT BECAUSE THE INDIVIDUALS IN
THE STUDY HAD NO TREATMENT AT
ALL AND THEN DEVELOPED NO
SYMPTOMS OF SYPHILIS, IN FACT,
MANY OF THEM ACTUALLY HAD BETTER
HEALTH OUTCOMES THAN THE ONES
THAT THEY ACTUALLY TRIED TO
TREAT SO THERE WAS A QUESTION
OUT THERE ABOUT CAN SYPHILIS BE
BETTER MANAGED IF YOU DON'T
TREAT IT AT ALL? SO THE
SCIENTIFIC QUESTION WAS AN
IMPORTANT ONE TO HAVE AND PLUS
SYPHILIS WAS AN STD AND THE
PUBLIC HEALTH KNEW THE
RESPONSIBLE THING TO DO WAS TO
ANSWER QUESTIONS SURROUNDING IT.
IN TERMS OF THE TIMING THE ENTRY
INTO THE STUDY WAS VOLUNTARY BUT
IT ACTUALLY WASN'T. THEY
THOUGHT THAT THEY WERE ENTERING
A TREATMENT PROGRAM. THEY DID
NOT KNOW THEY WERE ENTERING A
RESEARCH STUDY SO IT WAS
DECEPTION AND THERE'S NO WAY YOU
CAN HAVE THAT WITH DECEPTION.
DO GOOD, THE BENEFITS WERE
PRESENTED TO THEM IF THEY STAYED
IN THE STUDY THEY WOULD GET FREE
ROOM AND BOARD. SO GOOD
HEALTH-WISE WAS NOT THERE BUT
THEY SORT OF MASKED THESE
BENEFITS BY TALKING ABOUT OTHER
BENEFITS THEY KNEW THIS
POPULATION WOULD REALLY LIKE BUT
IN TERMS OF JUSTICE THAT'S WHERE
THE STUDY REALLY FAILED BECAUSE
IN TERMS OF SOCIAL JUSTICE,
DIGNITY AND RESPECT, IT WAS
NONEXISTENT IN THIS POPULATION
AND SO THE ETHICS OF THE STUDY
WERE MARGINAL AND THE ETHICS
WERE IN A SITUATION WHERE
NOTHING GOOD FROM ETHICS
STANDPOINT COULD COME OUT OF
THIS RESEARCH. BUT LET'S FAST
FORWARD IT TO AFTER THE
REGULATIONS AND AS RECENTLY AS
2015/16 THERE WAS A STUDY OF
INTERNAL MEDICINE INTERNS SO
FIRST YEAR RESIDENTS. AND THE
STUDY WAS TO SEE IF FIRST YEAR
RESIDENTS COULD TAKE ON THE SAME
WORKLOAD AS RESIDENTS IN THEIR
SECOND, THIRD OR FOURTH YEAR AND
WHAT THEY DID WAS THEY EXPOSED
THESE RESIDENTS TO VERY, VERY
LONG HOURS. VERY, VERY LONG
HOURS AND THEY WERE OBSERVED
TAKING ON THESE LONG HOURS FROM
A REGULATORY STANDPOINT MANY DID
NOT PARTICIPATE IN THIS RESEARCH
AND AT THE MOST IT WOULD GET AN
EXPEDITED REVIEW FROM ONE THAT
WAS PART OF THE STUDY. LET'S
LOOK AT THE ETHICAL
CONSIDERATIONS. THE MEDICAL
NECESSITY, THERE WAS CONCERN
THAT INFLEXIBLE DUTY HOUR RULES
IN MEDICAL RESIDENCY PROGRAMS
WOULD ADVERSELY AFFECT THE
TRAINING OF PHYSICIANS SO THEY
NEEDED TO FIGURE OUT IF THERE
WAS A WAY TO LOOK AT THOSE
RULES. A AUTONOMY, NOT REALLY
THESE RESIDENTS WERE VOLUNTARY
IN THESE STUDIES AND SAID IF YOU
WANT TO BE PART OF THIS
RESIDENCY PROGRAM YOU HAVE TO BE
PART OF THIS STUDY. DO NO HARM.
BECAUSE OF THESE LONG HOURS
THESE INDIVIDUALS EXPERIENCED
PATIENT ERRORS BECAUSE OF
PHYSICAL FATIGUE. THE RESIDENTS
AND THE PATIENTS THEY TREATED
WERE ALSO SUBJECT TO HARM AS
WELL AND THEN DO GOOD. THE
BENEFITS WERE REALLY TO TALK
ABOUT HOW THEY WOULD STAND UP TO
STANDARDS. AND NOT REALLY HOW
THEY WOULD BE ABLE TO IMPACT THE
PROFESSIONAL. SO LET'S LOOK AT
THIS A LITTLE BIT MORE. SO DO
WE HAVE OUR ANSWER YET? SHOULD
THERE BE MORE ETHICS OR
COMPLIANCE? SO THE REGULATIONS
WERE WRITTEN IN LIGHT OF
UNETHICAL RESEARCH. SO THE
COMPLIANCE CAME IN THE ABSENCE
OF THIS. THINGS LIKE COERCION,
UNDUE INFLUENCE, DECEPTION,
HARM, CAN FOCUS ON COMPLIANCE
WITH REGULATIONS ALONE
ADEQUATELY ADDRESS THE
MEANINGFUL PROTECTION OF HUMAN
SUBJECTS IN -- PARTICULARLY IN
CLINICAL RESEARCH? SO LET'S
LOOK AT WHAT BEECHER WAS REALLY
TRYING TO TELL US. BEECHER
SAID, THE INVESTIGATOR REALLY
HOLDS THE KEY TO THIS, HE SAID
THAT THE INVESTIGATOR -- TMORE
RELIABLE SAFEGUARD IS THE
PRESENCE OF AN INTELLIGENT
INVESTIGATOR SO IF THE
INVESTIGATOR IS ETHICAL THEN THE
RESEARCH SHOULD FOLLOW IN AN
ETHICAL WAY. AND HE ASSERTED
THE RESEARCHERS ARE REALLY NOT
MALICIOUS OR EVIL BUT THEY'RE,
RATHER, THOUGHTLESS OR CARELESS
SO THESE INCIDENTS OF UNETHICAL
RESEARCH WERE NOT OKAY,
INDIVIDUALS TRYING TO
NECESSARILY DO HARM. IN SOME OF
THE CASES THERE WAS EGREGIOUS
MALICIOUS OR EVIL BUT SOME
SITUATIONS WHERE THE PURSUIT OF
ANSWERING THE QUESTION TOOK
PRECEDENT OVER THE NEED TO
PROTECT DIGNITY AND THE RESPECT
OF INDIVIDUALS. BEECHER SAID
THERE NEEDS TO BE MORE SELF
SCRUTINY RATHER THAN PUBLIC
REVIEW THAT'S ONE OF THE REASONS
HE DIDN'T CITE ANY OF THE
INVESTIGATORS IN HIS EXPOSE AND
SAID THAT THE PROFESSION OF
HUMAN SUBJECTS RESEARCH DID NOT
NEED MORE OUTSIDE REGULATION.
BUT BETTER MECHANISMS FOR
SELF-REGULATION, SELF-POLICING
AND ETHICAL DECISION-MAKING HE
QUESTION -- DESIRED TO ROCK THE
PROFES
PROFESSION.
REGULATIONS ARE THE FLOOR BUT
THERE ISN'T ANY SUBSTITUTE OF
GOOD JUDGMENT SO THAT'S WHERE WE
SEE THE CONVERSIONINGS,
REGULATIONS CREATE A FOUNDATION
OF HOW WE FOLLOW A SET OF
GUIDELINES. BUT WE HAVE TO DO
THAT IN CONCERT WITH THE
JUDGMENT. THAT'S WHERE THE
ETHICAL DECISION-MAKING COMES
IN. THERE'S SO MANY TIMES WHERE
WE -- WHERE SOMETHING COMES UP
IN HUMAN SUBJECT RESEARCH THAT
THERE'S NOT A REGULATION THAT
DIRECTLY ADDRESSES IT AND AT
THAT POINT THAT'S WHERE THE GOOD
JUDGMENT IS PARAMOUNT. USE
ETHICAL DECISION-MAKING TO
COMPLEMENT COMPLIANCE. IT'S NOT
JUST WHAT THE RULES SAY BUT
THINK ABOUT WHAT IS THE RIGHT
THING TO DO. AND APPLY BOTH
ETHICAL AND CONSIDERATIONS AND
REGULATORY CONSIDERATIONS WHEN
REVIEWING THESE HIGH RISK
CLINICAL STUDIES BECAUSE THESE
HELP US PUT US IN THE BEST
POSSIBLE SITUATION WHERE WE CAN
PROTECT THESE INDIVIDUALS.
FOCUS ON OUTCOMES WHICH CONSIDER
ALL THE STAKEHOLDERS. SO THE
BOTTOM LINE, ANYONE CAN
POTENTIALLY BE HARMED IN HARM'S
WAY AS A SUBJECT RESEARCH. IT'S
NOT ABOUT THE CATEGORY THEY'RE
IN AND TO A LARGER RISK ABOUT
THE CONTEXT. THE LACK OF
INDEPENDENCE AND IMPORTANCE CAN
BE ANYONE'S SITUATION AT ANY
GIVEN TIME. RESPECT FOR PERSONS
IS AN ETHICAL PRINCIPLE BUT IT'S
MUCH MORE THAN OBTAINING
INFORMED CONSENT. RESPECT FOR
PERSONS TALKS ABOUT TRUST, TALKS
ABOUT COMPASSION, TALKS ABOUT
COMMUNICATION THAT IS BOTH
ETHICAL IN NATURE BUT ALSO
GARNERS AN ENVIRONMENT OF
DIGNITY AND RESPECT. AND WE
HAVE TO ALWAYS REMEMBER THE GOOD
OF SCIENCE CAN NEVER BE
CONSIDERED OVER THE IMPORTANCE
OF HUMAN LIFE. ACCOUNTABILITY,
RESPONSIBILITY BUT ALSO THAT
ETHICAL JUDGMENT THAT SURROUNDS
THESE DECISIONS THAT WE MAKE AND
THEN LASTLY ETHICS AND
COMPLIANCE ARE NOT MUTUALLY
EXCLUSIVE. IRBS, ALTHOUGH
THEY'RE FOLLOWING GUIDELINES AND
REGULATIONS THEY CAN CONSIDER
ETHICS IN CONCERT, IN CONCERT
WITH FOLLOWING THOSE SETS OF
GUIDELINES AND REGULATIONS. SO,
AS ARISTOTLE SAID WITH REGARDS
TO EXCELLENCE IS NOT ENOUGH TO
KNOW WHAT TO DO, WE MUST TRY TO
HAVE IT AND WE MUST USE IT. AND
I JUST ENCOURAGE US CONTINUE TO
BE STUDENTS OF THE REGULATIONS,
BUT ALSO CONTINUE TO REFINE YOUR
ABILITY TO MAKE ETHICAL
DECISION-MAKING BECAUSE IT IS
GOING TO TAKE BOTH COMPLIANCE
AND ETHICS TO REALLY BE
EXCELLENT IN THIS WORK AND I
WILL NOW FIELD QUESTIONS AND
DISCUSSIONS.
>>PEG: THANK YOU, THAT WAS
WONDERFUL. PLEASE THOSE WHO
HAVE QUESTIONS IN THIS SESSION
WE'D LOVE TO HEAR THEM. PLEASE
PUT THEM IN THE BOX BELOW THE
VIDEO ENTITLED LIVE FEEDBACK
LINK AND HOPEFULLY THOSE WILL GO
THROUGH QUICKLY. JONATHAN, DO
YOU HAVE COMMENTS OR QUESTIONS?
>>JONATHAN: I HAVE A COUPLE
THOUGHTS SO THANK YOU, QUINCY.
GREAT TALK. TRYING TO THINK OF
HOW TO REALLY FORMULATE THIS.
SO IT'S SORT OF A TWO PART
RELATED ISSUE. I MEAN, SO ONE
PART IS, DO WE HAVE A PROBLEM --
YOU KNOW, BEECHER WAS A 1966,
YOU KNOW, WE HAVE THE -- THERE
WAS THE OBVIOUS TUSKEGEE AND
OTHER THINGS THAT YOU TALKED
ABOUT BUT, I DON'T KNOW, HAVE WE
FIXED THE PROBLEM? RIGHT? YOU
KNOW, EVERYBODY TAKES THEIR
TRAINING, EVERYBODY HAS THEIR
IRB, YEAH, WE GET THIS AND THAT,
WE'RE NOT FOLLOWING SOME RULES
BUT HAVE WE REALLY -- DO WE
STILL HAVE A PROBLEM? OR NOT
AND THE SECOND THING KIND OF
RELATED TO THIS IS THINKING
ABOUT, YOU KNOW, HOW RESEARCH IS
CHANGED AS AN ENTITY AND I DON'T
MEAN JUST LIKE THE KIND OF
RESEARCH BUT AND HOW YOU THINK
THIS MIGHT IMPACT THINGS.
RESEARCH IS NOW BIG BUSINESS.
IT WASN'T SUCH BIG BUSINESS IN
1966. RIGHT? INSTITUTIONS
DEPEND UPON RESEARCH DOLLARS.
TALL BIG SEGMENTS OF THE ECONOMY
DEPEND ON THIS AND HOW HAS THAT
CHANGED THINGS DO YOU THINK?
>>QUINCY: GREAT. I WILL ANSWER
THE FIRST QUESTION FIRST. HAVE
WE FIXED THIS AND I WILL ANSWER
THIS LIKE AN ADMINISTRATOR. I
WILL SAY IT DEPENDS. SO WHAT I
MEAN BY THAT IS, IRB ARE STILL
WIRED TO THINK HOW DOES THIS
PROJECT ALIGN WITH THE
REGULATIONS? AND THAT IS --
THAT'S WHAT THEY NEED TO DO. I
THINK WHAT'S STILL NEEDS SOME
WORK, JONATHAN IS THE IRBS HAVE
TO REMEMBER THE REASON THEY WERE
CREATED AND THE REASON THEY WERE
CREATED WAS TO PROTECT
INDIVIDUALS THAT ARE
PARTICIPATING IN RESEARCH. NOT
TO CHECK OFF BOXES THAT A
RESEARCH PROJECT MEETS
REGULATIONS. NOW, THE
REGULATIONS HAVE BEEN A GREAT
GUIDE BECAUSE REGULATIONS REALLY
HELP US TO BE ETHICAL BUT WHAT
IRBS CAN CONFUSE IS BECAUSE THIS
RESEARCH FOLLOWS A SET OF
GUIDELINES, DOES IT MAKE IT
DEFAULT ETHICAL? IT MAKES IT
COMPLIANT BUT DOESN'T
NECESSARILY DEFAULTILY MAKE IT
ETHICAL. IT DECREASES THE
LIKELIHOOD OF MAKING IT ETHICAL
IF IT IS FOLLOWING REGULATIONS
AND MOST OF THESE ARE CUT AND
DRY. THESE FOLLOW REGULATIONS
AND THIS IS WELL PUT TOGETHER,
IS ETHICAL AND IS COMPLIANT AND
WE'RE GOOD TO GO. IT'S ONLY IN
THOSE SITUATIONS WHERE, WHEN I
HEAR PEOPLE SAY, JONATHAN, WELL
THE REGULATIONS DON'T SAY I
CAN'T DO THIS. WHENEVER I HEAR
THAT, THAT'S WHEN I START TO
WORRY ABOUT US EFFECTIVELY
MAXIMIZING THAT CONVERGENCE
BETWEEN ETHICS AND COMPLIANCE.
IT'S SORT OF THAT JURY RASSIC
PARK, QUOTE, YOU THOUGHT ABOUT
WHETHER YOU COULD DO IT BUT YOU
DIDN'T THINK ABOUT WHETHER YOU
SHOULD. AND SO THAT IS WHERE
THAT CONVERGENCE COMES IN THOSE
SITUATIONS WHERE SOMEONE IS
QUESTIONING WHETHER THE
REGULATION PROHIBITS. THIS SO
WE CAN DO IT. THAT'S WHERE YOUR
ETHICAL DECISION-MAKING AND YOUR
JUDGMENT HAS TO BE IMMEDIATELY
PUT ON AND MAYBE YOU CAN. BUT
YOU HAVE TO PUT ON YOUR GOOD
JUDGMENT HAT AND YOUR COMPLIANCE
HAT ON STATEMENT, TO YOUR SECOND
QUESTION ABOUT THE BIG BUSINESS,
THE BIG BUSINESS IS REALLY
CHANGED WHAT MOTIVATES PEOPLE TO
EITHER PARTICIPATE AS
INVESTIGATORS EVEN HAS CHANGED
HOW ORGANIZATIONS ARE MOTIVATED
IN GETTING TO THE WHOLE THING
ABOUT INQUIRY AND DISCOVERY.
ONE OF THE, YOU KNOW, MOST
PUBLIC FACING EPISODES IN
INETHICAL RESEARCH IS JESSE AND
IF YOU THINK ABOUT WHAT WAS
BEHIND THAT IT WASN'T JUST ABOUT
SOMEONE BEING UNETHICAL. THERE
WAS A LOT OF MONEY THAT STOOD TO
BE GAINED IF THIS STUDY WAS
SUCCESSFUL. AND THERE WAS A
SITUATION WHERE THAT MONEY
ALMOST -- THE MISMANAGEMENT OF
THAT CONFLICT OF INTEREST CAUSED
A HUMAN SUBJECT TO BE -- THE
PRESSURE TO ENROLL SUBJECTS IN
THE CLINICAL RESEARCH WORLD,
RIGHT, I DON'T GET PAID AS A
SITE UNLESS I ENROLL, RIGHT?
AND THE MORE I ENROLL, JONATHAN
THE MORE I MAKE AT MY SITE THE
MORE LIKELY THAT COMPANY IS
GOING TO REACH OUT TO MY SITE
AGAIN TO ENROLL SO NOW YOU HAVE
THESE INFLUENCES THAT MAKE IT
EVEN MORE IMPORTANT FOR US TO
LEAN ON OUR COMPLIANCE EXPERTISE
BUT ALSO OUR ETHICS EXPERTISE
BECAUSE THERE'S A LOT OF THINGS
THAT CAN SLIP THROUGH THE CRACKS
IF WE'RE NOT CAREFUL BECAUSE WE
SEE THE MONETARY AND PRESTIGE
GAIN THAT COMES FROM THESE
THINGS. I THINK THOSE ARE GREAT
QUESTIONS.
>>PEG: OKAY WE DO HAVE A COUPLE
QUESTIONS HERE.
>>QUINCY: ALL RIGHT. GREAT.
>>PEG: STANDING BETWEEN AN
INVESTIG
INVESTIGATOR'S CONSIDERATIONS
ARE EXTERNAL PRESSURES,
PRESSURES TO PRODUCE RESEARCH,
PRESSURES TO MOVE PRODUCTS
THROUGH A PIPELINE, ET CETERA,
DO YOU HAVE RECOMMENDATIONS ON
HOW REGULATIONS COULD TARGET
THOSE PRESSURES RATHER THAN
TRYING TO RETROSPECTIVELY
ADDRESS PAST ETHICAL MISTAKES?
>>QUINCY: YEAH, SO REGULATIONS
HAVE THE SAME RULES. AND THE
REGULATIONS UNFORTUNATELY
PROTECT THE ENTITIES THAT CREATE
THEM MORE SO THAN THEY PROTECT
THE PEOPLE THAT THEY'RE DESIGNED
TO PROTECT. SO IF YOU THINK
ABOUT THE REGULATIONS AND THE
COMMON RULE, IT WAS, YOU KNOW,
THE COMMON RULE WAS WRITTEN
IN -- OSTENSIBLY WAS TO PROTECT
THE SUBJECT BUT ALSO PROTECTED
THE FUNDING AGENCIES THAT SAID,
HEY, EVEN IF THIS DOES OCCUR IT
WASN'T ON OUR DIME AND WE EVEN
SPECIFIED IF IT'S FUNDED BY THE
FEDERAL GOVERNMENT THAT'S --
WHEN THESE REGULATIONS APPLY.
IT DIDN'T APPLY UNIVERSALLY TO
ANY HUMAN RESEARCH. TO ANSWER
YOUR QUESTION I THINK HOW
REGULATIONS CAN HELP IS REMOVE
SO MANY QUALIFIERS. AND MAKE IT
MORE ABOUT THE BENEFICIARY OF
THESE REGULATIONS TO -- THAT ARE
DESIGNED TO PROTECT THEM. THE
REGULATIONS NEED TO QUIT
FOCUSING SO MUCH ON WHO'S PAYING
FOR THE RESEARCH, FOCUS IT ON SO
MUCH ON WHO IS LIABLE FOR THE
RESEARCH, WHO GETS THE BLAME FOR
THE RESEARCH BEING UNETHICAL.
SPEND TIME ON THAT, SPEND JUST
AS MUCH TIME ON WHAT REGULATIONS
WILL ACTUALLY PROTECT THE
INDIVIDUALS THAT ARE GOING TO
PARTICIPATE IN RESEARCH. NOW I
THINK THAT WE HAVE A LITTLE WAYS
TO GO THERE. BUT RIGHT NOW THE
REGULATIONS I THINK SPEND TOO
MUCH TIME PROTECTING THE
REGULATORS AND NOT ENOUGH TIME
PROTECTING THE SUBJECTS.
>>PEG: OKAY. NEXT QUESTION IS
CAN A PROTOCOL FORM BE USED TO
PROMOTE ETHICS OR IS IT ALWAYS
JUST FOCUSED ON COMPLIANCE WITH
THE REGS?
>>QUINCY: MOST OF THE IRB
REFORM I SEE IS THEIR COMPLIANCE
FORMS SO THEY HAVE THE LIST OF
THE CRITERIA. GO THROUGH THE
CRITERIA FOR APPROVAL. SUBJECT
DESIGN IN SUCH A WAY THAT THE
RISKS ARE MINIMIZED IN RELATION
TO THE BENEFITS. INFORMED
CONCEPT IS DOCUMENT. BLAH BLAH
BLAH. IN EACH OF THOSE CRITERIA
I ASK THEM TO WRITE THE ETHICAL
CONSIDERATION AND HOW ETHICALLY
THE STUDY MEETS THAT CRITERIA.
LET ME GIVE YOU AN EXAMPLE.
INFORMED CONSENT, YES, IT'S
DOCUMENTED AS THE REGULATORY
INFORMED CONSENT. ETHICALLY
TALK ABOUT THE PROCESS. SO, IS
THE PROCESS BEING CONDUCTED IN
AN ENVIRONMENT THAT DOES NOT
UNDULY INFLUENCE? COERCE?
THESE THINGS ARE NOT SPELLED OUT
IN THE REGS, AT LEAST NOT IN A
SPECIFIC WAY. SO WHAT I HAVE
THEM DO IS I WRITE -- I HAVE
THEM LOOK AT BOTH THE REGULATORY
CONSIDERATION AND THE ETHICS
CONSIDERATION EVEN WHEN THEY
WERE TRYING TO FIGURE OUT
WHETHER OR NOT THIS RESEARCH
PROJECT MEETS THE CRITERIA FOR
APPROVAL AND THAT WAS RECEIVED
WELL BECAUSE IT MAKES THEM THINK
DOES THIS ALLOW ARE FROM THE
REGS BUT IS THIS REALLY ETHICAL
RESEARCH? GREAT QUESTION.
>>PEG: OKAY, WE HAVE ANOTHER
ONE THAT IS GOING TO BE
CHALLENGING HOW DO WE TEACH
ETHICAL THINKING? HOW DO WE
TEACH ETHICAL THINKING IN THE
CONTEXT OUTSIDE OF HUMAN
INTERACTION? BUT WITH PATIENT
AND HUMAN DATA, RESPONSES,
SAMPLES, ET CETERA?
>>QUINCY: SO HOW YOU TEACH
ETHICAL THINKING? SO THAT'S A
GREAT QUESTION. SO I DON'T KNOW
IF YOU CAN TEACH SOMEBODY TO BE
ETHICAL. THAT IS SOMETHING THAT
SOMEONE HAS TO BE ABLE TO WANT
TO DO. THAT'S WHY THE
COMPLIANCE IS SO IMPORTANT
BECAUSE COMPLIANCE MAKES YOU
FOLLOW A SET OF GUIDELINES.
WHAT WE CAN TEACH IS WE CAN
TEACH STRATEGIES FOR ETHICAL
DECISION-MAKING. WHICH IS A
LITTLE BIT DIFFERENT THAN
TEACHING SOMEONE TO BE ETHICAL.
STRATEGIES FOR ETHICAL
DECISION-MAKING MEAN HOW DO YOU
DEFINE A PROBLEM? HOW DO YOU
WEIGH THE ALTERNATIVE OPTIONS?
HOW DO YOU ARRIVE AT A DECISION?
HOW DO YOU CONSIDER STAKEHOLDERS
IN DECISIONS SO THERE'S A
METHODOLOGY IN THIS DECISION AND
I THINK THAT'S WHAT WE NEED TO
TEACH. THAT WAY AS INDIVIDUALS,
DESIGNED TO BE MORE ETHICAL
THERE'S A LIST OF STEPS THAT
THEY CAN TAKE THAT WILL PUT THEM
IN A BETTER POSITION RIGHT, TO
MAKE AN ETHICAL DECISION THAN
NOT. BUT IN TERMS OF TEACHING
SOMEONE ETHICAL THINKING, I
DON'T KNOW THAT THAT IS
POSSIBLE. BECAUSE EVERYONE HAS
THEIR OWN -- AND I'M GOING TO
GET A LITTLE TOUCHY-FEELY HERE
IF YOU DON'T MIND. EVERYONE HAS
THEIR OWN MORAL COMPASS THAT
GUIDES WHAT THEY DO. SO ALL I
CAN DO IS GIVE THEM STRATEGIES
AND STEPS TO TAP IN TO WHAT I
ASSUME TO BE AN APPROPRIATE
ETHICAL COMPASS TO BE A
RESEARCHER IN THIS SPACE.
>>PEG: OKAY, THANK YOU.
>>QUINCY: DID I SKIRT AROUND
THAT QUESTION ENOUGH FOR THAT?
>>PEG: I THINK IT'S A REALLY
TOUGH QUESTION.
>>QUINCY: YEAH, IT IS AND I
TEACH ETHICS, RIGHT, I TEACH
ETHICS IN HEALTH CARE, I TEACH
THAT COURSE AND, YEAH, AND I
TELL THEM, LOOK, AFTER YOU GET
THROUGH THIS COURSE, THIS COURSE
DOESN'T MAKE YOU MORE ETHICAL
BUT GIVES YOU THE TOOLS YOU NEED
TO MAKE DECISIONS THAT ARE IN
THE BEST INTEREST OF THE PEOPLE,
OF THE PATIENTS, THE BEST
INTEREST OF THE PROFESSION AND
JUST THE BEST INTEREST OF THE
GREATER GOOD.
>>JONATHAN: I AM GOING TO
EXERCISE CHAIR DISCRETION HERE.
AND SAY, JUST GIVE YOU SOMETHING
TO RESPOND TO BECAUSE I'VE BEEN
THINKING A LOT ABOUT RECENTLY.
SO YOU KNOW, I LOVE THAT QUOTE
FROM THE BEECHER PAPER. I THINK
ABOUT THAT A LOT THAT YOU'VE
SHOWED THAT THE MORE RELIABLE
PROTECTION IS THE RESPONSIBLE
INVESTIGATOR AND, YOU KNOW, SO
WHEN I THINK ABOUT HOW HUMAN
SUBJECTS RESEARCH IS CONDUCTED
ETHICALLY, OR PROPERLY AND HOW,
YOU KNOW, IRBS, WE CAN DO -- WE
CAN REVIEW HUNDREDS OF THOUSANDS
OF PROTOCOL, WHATEVER, WE CAN
READ THE PROTOCOL, WE CAN FIND
ANYTHING THAT LOOKS GREAT ON
PAPER BUT THE RUBBER HITS THE
ROAD AT THE BEDSIDE IT DOESN'T
MATTER WHAT THE IRB DOES IF THE
ACTIONS OF THE BEDSIDE ARE, YOU
KNOW, WHATEVER WORD WE WANT TO
PUT ON IT. NONCOMPLIANT, NOT
ETHICAL OR NOT IN THAT
INDIVIDUAL INTEREST AT THE TIME.
AND I THINK AS ONE OF THE OTHER
QUESTIONS SORT OF ELUDED TO,
THERE'S A LOT -- AND AS WE
TALKED, THERE ARE A LOT OF
PRESSURES ON THAT PERSON AT
THE -- ON THE INVESTIGATOR THAT
EVERYTHING FROM, YOU KNOW, A
GOOD SCIENTIST BELIEVES IN THEIR
HYPOTHESIS AND IT'S HARD TO ASK
THEM TO STEP ASIDE AND IF THEY
DON'T BELIEVE IN THEIR
HYPOTHESIS I DON'T WANT TO DO
THE EXPERIMENT EITHER. YOU GOT
THAT TOOK R FACTOR AND IT'S
PUBLISH OR PERISH. I DON'T GET
THIS PAPER, I DON'T GET THE NEXT
GRANT OR TENURE AND ALL OF THOSE
THINGS THAT ARE DISTORTED
INCENTIVES THAT CAN EVEN MAKE
GOOD PEOPLE INADVERTENTLY MAKE
BAD DECISIONS.
AND, YOU KNOW, IRBS CAN'T DO
ANYTHING ABOUT THAT.
>>QUINCY: THAT'S RIGHT.
>>JONATHAN: WE TEND TO THINK,
WELL, THE WHOLE THING FOR HUMAN
RESEARCH PROTECTIONS LIES IN THE
IRB BUT IT'S A WHOLE SYSTEM AND
I RECENTLY READ THE REPORT FROM
UNIVERSITY OF MADISON AND
SOMETHING STRUCK ME IMMEDIATELY
SO THEY COINED THIS TERM, HUMAN
RESEARCH PARTICIPANT PROTECTION
PROGRAMS. IT HAD THREE PS, NOW
WE ALL TALK ABOUT TWO P, HUMAN
RESEARCH PROTECTION PROGRAM.
LOST THAT THIRD P SOMEWHERE FROM
2003. BUT THEY, YOU KNOW,
REALLY NICELY TALKS ABOUT ALL OF
THE DIFFERENT ELEMENTS THAT WE
HAVE TO DO THAT RANGING -- THE
IRBS JUST WANT A STAB AT THIS
BUT THE ROLE OF THE
INVESTIGATOR, THE FUNDER, THE
ROLE OF RESEARCH AS IT'S BEING
DONE OF THE MONITORING, ALL OF
THESE THINGS THAT HAVE TO WORK
TOGETHER TO MAKE THIS REALLY
COMPLICATED AND IMPORTANT
ENDEAVOR WORK FOR EVERYBODY'S
INTEREST. AND DESPITE
EVERYTHING, PEOPLE ARE STILL
GOING TO GET HARMED.
>>QUINCY: YEAH, I THINK -- YOU
BRING UP A GOOD POINT, JONATHAN,
IRB CANNOT PROTECT THE SUBJECT.
AT LEAST NOT IN A DIRECT WAY.
RIGHT IN THE IRB REVIEWS HOW AN
INVESTIGATOR IS DESCRIBED AND
WHAT THEY'RE GOING TO DO TO
ANSWER THIS RESEARCH QUESTION
AND TO TEST THIS HYPOTHESIS AND
IRB ASSESSES WHETHER OR NOT WHAT
WAS DESCRIBED IF THAT
INVESTIGATOR, TO YOUR POINT, IF
THAT INVESTIGATOR DOES IT EXA
EXACTLY HOW THEY DESCRIBE IT TO
THE IRB THAT OPTIMIZING
PROTECTION OF THE HUMAN RESEARCH
PARTICIPANTS BUT THEN THEY LEAVE
THE IRB. RIGHT? SO THEY'RE NOT
IN THE PRESENCE OF THE IRB
ANYMORE NOW THE RUBBER IS
HITTING THE ROAD IS THAT
INVESTIGATOR GOING TO BE ABLE TO
DO WHAT THEY DESCRIBED TO THE
IRB THAT THEY'RE GOING TO DO AND
THEN WHAT IS THE IRB'S ROLE IN
POST-APPROVAL MONITORING TO MAKE
SURE THAT WHAT WAS DESCRIBED TO
THEM INITIALLY IS WHAT THEY'RE
ACTUALLY DOING? AND YOU DON'T
KNOW THAT. UNLESS YOU HAVE SOME
SORT OF A MECHANISM IN PLACE TO
EVALUATE THAT. BUT YOU BRING UP
AN EXCELLENT POINT BECAUSE,
YEAH, I WISH IT WAS THAT EASY,
THE IRB YOU JUST PROTECT
EVERYBODY BUT THEY CAN'T.
THAT'S NOT PRACTICAL. IT'S NOT
REALISTIC AND IT TAKES A
COMMUNITY OF PEOPLE THAT ARE
VESTED IN PROTECTING THESE
INDIVIDUALS FOR THIS TO WORK.
SO --
>>PEG: CAN YOU SPEAK TO THE
INDIVIDUALS WHO PARTICIPATE IN
PEDIATRIC PARTICIPANTS?
>>QUINCY: THAT'S A WHOLE TALK.
THAT'S A HARD ONE. BECAUSE
CHILDREN ARE VERY, VERY
VULNERABLE. PARTICULARLY THE
YOUNGER THEY ARE THE MORE
VULNERABLE THEY ARE. THEY'RE
VULNERABLE FOR MANY REASONS.
THEY'RE VULNERABLE BECAUSE
THEY'RE CHILDREN, BUT THEY'RE
ALSO VULNERABLE BECAUSE THEY ARE
UNDER THE AUTHORITY OF PARENTS.
SO THEY CAN'T EVEN MAKE THEIR
OWN DECISIONS FROM A HEALTH CARE
PERSPECTIVE MUCH LESS FOR
RESEARCH PERSPECTIVE. SO WE PUT
THINGS IN PLACE TO HAVE THE
CHILD IF THEY ARE THE AGE OF
CONSENT, AND PARENTAL PERMISSION
TO PUT SOMETHING IN PLACE FOR
THEM. HERE'S THE FLIP SIDE OF
THIS, THIS IS WHY THIS GETS
DICEY. WE NEED ACTUALLY -- WE
ACTUALLY NEED MORE PEDIATRIC
RESEARCH AND HERE'S WHY BECAUSE
OF HOW WE GET MEDICINES -- HOW
WE PRESCRIBE MEDICINES TO
CHILDREN. HISTORICALLY AND
JONATHAN CAN SPEAK TO THIS TOO
HISTORICALLY IT'S BEEN DONE BY
EYEBALLING IT. AN ADULT GETS
THIS MANY MILLIGRAMS SO, HM, A
KID WILL GET HALF OF THIS BUT
THERE'S NO RESEARCH PEGGED TO
SAY THAT THIS WAS A SAFE DOSE IN
A CHILD. SO WE WENT FOR DECADES
AND DECADES EYEBALLING THINGS,
NEVER TESTING IT IN CHILDREN AND
CHILDREN WERE BEING HARMED
SEVERELY BECAUSE WE WERE
EYEBALLING TREATMENTS FOR THAT
SO ON THE ONE SIDE WE NEED TO DO
MORE RESEARCH AND WHAT IS SAFE
AND EFFECTIVE FOR THAT
POPULATION. BUT AT THE SAME
TIME, WE HAVE TO MAKE SURE THAT
THAT DESIRE TO GET MORE
QUESTIONS ANSWERED IN THAT
POPULATION DOESN'T MAKE THEM BE
MORE IN HARM'S WAY BECAUSE THEIR
STILL VULNERABLE ALTHOUGH WE
NEED TO GET THAT INFORMATION FOR
THE GREATER GOOD OF PEDIATRIC
POPULATIONS WE HAVE TO PROTECT
THOSE INDIVIDUALS EVEN MORE SO
THAT ARE ACTUALLY PARTICIPATING
IN THE RESEARCH. SO PEDIATRIC
RESEARCH, IT'S A COMPLICATED
SITUATION, RIGHT, AND
UNFORTUNATELY SOME OF THE
HISTORICAL UNETHICAL THINGS
INVOLVE CHILDREN EVEN IN THE
CONCENTRATION CAMPS. SOME OF
THE TWIN STUDIES WERE DONE IN
CHILDREN. AND WHAT HAPPENED IN
WILLOWBROOK, WHAT HAPPENED IN
THE DAVID RAYMER CASE AND WHAT
HAPPENED WITH MANY OF YOU
PROBABLY SAW THE DOCUMENTARY
THREE IDENTICAL STRANGERS. THEY
WERE BABIES WHEN THEY BECAME
PART OF THIS EXPERIMENT AND NO
ONE WAS THERE TO PROTECT THEM.
SO, YEAH, PEDIATRIC RESEARCH.
WE HAVE TO PROTECT THEM. BUT AT
THE SAME TIME, WE HAVE TO -- WE
CANNOT LET -- NOT LOSE SIGHT OF
THE IMPORTANCE OF DOING RESEARCH
IN PEDIATRIC POPULATIONS.
>>PEG: JONATHAN, ANYTHING ELSE
YOU WANT TO SAY ON THAT TOPIC?
>>JONATHAN: NO, LIKE I SAID, WE
COULD TALK FOR MANY HOURS ABOUT
THE CHALLENGES OF PEDIATRIC
RESEARCH. YES, WE HAVE TO DO IT
BUT WE HAVE TO DO IT WELL.
>>QUINCY: YEAH. YEAH.
>>JONATHAN: SO, ANYWAY, THANK
YOU.
>>PEG: GREAT, I THINK THAT'S
FOR OUR QUESTIONS TODAY. SO ON
BEHALF OF OUR OHSRP DR. GREEN
AND I WOULD LIKE TO THANK YOU
VERY MUCH FOR THIS. A VERY
THOUGHTFUL PROVOKING
PRESENTATION.
>>QUINCY: WELL THANK YOU, ALL,
FOR HAVING ME AND HOPEFULLY
WE'LL BE ABLE TO DO THIS AGAIN
IN THE FUTURE.
>>PEG: THAT WOULD BE GREAT,
THANK YOU. BYE-BYE.