>> GOOD MORNING.

CAN YOU HEAR ME?

GREAT.

MY NAME IS CHRISTINE GRADY.

I WORK HERE AT THE DEPARTMENT OF

BIOETHICS AT THE CLINICAL CENTER

OF THE NIH.

WE HAVE BEEN RUNNING THE COURSE,

I THINK THIS IS THE 13TH TIME, 

THE 13TH YEAR.

EVERY YEAR, WE HAVE HUNDREDS OF 

PEOPLE SIGNING UP.

I THINK PEOPLE ARE STILL 

FILTERING IN, IN THIS ROOM.

INCREASINGLY, OVER THE LAST FEW 

YEARS, WE HAVE LOTS OF 

PARTICIPANT THAT WATCH FROM 

REMOTE SITES.

AS YOU ARE SITTING HERE THERE 

ARE PEOPLE AS CLOSE AS ROCK 

LEDGE AND AS FAR AWAY AS 

TANZANIA AND CHILE WATCHING AS 

WELL.

I WANT TO THANK THE GROUP IN MY 

OFFICE THAT HELPED PUT THIS 

TOGETHER, IN PARTICULAR, MERTA 

STALLING THAT DOES REG 

STRICTION.

BECKY CHEN, TONYA VAUGHN HELPED 

PUT THIS COURSE TOGETHER AS 

WELL. 

>> THE GOAL OF OUR COURSE IS TO 

DISCUSS THE MAJOR ETHICAL 

CONSIDERATIONS IN DESIGNING AND 

CONDUCTING CLINICAL RESEARCH FOR

RESEARCH IN HUMAN BEINGS.

THIS IS NOT A COURSE WHERE YOU 

WILL GO THROUGH THE DETAILS OF 

THE REGULATIONS OR LEARN HOW TO,

YOU KNOW, HOW TO COMPLY WITH 

REGULATIONS, IT IS RATHER A 

COURSE THAT WE HELP -- WE 

HOPE -- EXCUSE ME -- WE HOPE 

WILL HELP FURTHER YOUR THINKING 

ON WHAT SOME OF THE ETHICAL 

CHALLENGES ARE IN CLINICAL 

RESEARCH AND HOPE YOU CAN 

INCORPORATE SOME OF THE NEW 

KNOWLEDGE AND SENSITIVITY TO 

YOUR WORK NEITHER WRITING 

PROTOCOLS, HELPING TO CONDUCT 

PROTOCOL, REVIEWING PROTOCOLS, 

ALL OF THE ABOVE, WHATEVER YOUR 

PARTICULAR ASPECT OF INVOLVEMENT

WITH RESEARCH IS.

WE THINK IT IS IMPORTANT TO 

REMEMBER THAT ETHICS IS A FORM 

OF INQUIRY THAT HELPS US THINK 

AND JUDGE AT EVERY STEP ALONG 

THE WAY OF RESEARCH WHAT IS 

RIGHT AND WHAT IS WRONG.

IN MANY SITUATIONS, PERHAPS YOU 

ENCOUNTERED THEM ALREADY, YOU 

WILL CERTAINLY HEAR ABOUT THEM 

IN THE COURSE OF THIS COURSE, 

MANY SITUATIONS, THERE IS NOT 

ONE RIGHT WAY TO GO.

REASONABLE PEOPLE ACTUALLY 

DISAGREE ABOUT WHAT THE RIGHT 

WAY TO GO IS.

I THINK YOU WILL FIND SOME OF 

YOU WILL DISAGREE WITH EACH 

OTHER ABOUT SOME OF THE ISSUES.

THAT SEEMS TO ME, ACTUALLY, 

EXCITING.

THE IMPORTANT PART OF 

UNDERSTANDING ETHICS IS TO BE 

CLEAR ABOUT WHAT THE SOURCE OF 

THE DISAGREEMENT IS.

WHAT YOU BELIEVE, WHY YOU 

BELIEVE IT, WHAT THE ARGUMENTS 

ARE, BE ABLE TO JUSTIFY YOUR 

POSITION BASED ON SOLID 

REASONING.

AS YOU PROBABLY KNOW, THIS 

COURSE IS SEVEN WEEKS LONG.

IT IS STRUCTURED IN A WAY THAT 

EVERY WEDNESDAY MORNING WE HAVE 

THREE SESSIONS.

IT IS USUALLY THREE SPEAKERS, 

ALTHOUGH THERE ARE LOTS OF 

INTERACTIVE SESSIONS FILTERED 

THROUGHOUT THE COURSE.

EACH SESSION WILL BE A DIFFERENT

TOPIC.

THE SPEAKERS ARE ASKED TO GIVE A

CERTAIN AMOUNT OF PRESENTATION 

TO YOU AND TO LEAVE TIME AT THE 

END FOR QUESTIONS, COMMENTS AND 

DISCUSSION.

THIS INTERACTIVE SESSIONS WILL 

INCLUDE A MOCK I.R.B., FOR WHICH

I WILL REMIND YOU AGAIN TO 

REVIEW THE PROTOCOL ON YOUR C.D.

THERE WILL BE A PANEL OF 

INVESTIGATORS.

A PANEL OF RESEARCH PARTICIPANTS

AND CASE DISCUSSIONS AS WELL.

AND EVERY WEEK, WE HAVE A BREAK 

IN THE MIDDLE WHERE YOU CAN GET 

COFFEE GTO THE BATHROOM AS WELL.

QUESTIONS, IT IS VERY IMPORTANT,

BECAUSE THE ROOM IS BIG AND 

BECAUSE WE HAVE SO MANY REMOTE 

WATCHERS TO USE THE MIC.

IF YOU HAVE A QUESTION, USE THE 

MIC, IDENTIFY YOURSELF AND ASK 

THE QUESTION.

PROBABLY HAVE YOU THIS 

INFORMATION, BUT THE SYLLABUS 

YOU RECEIVED HAS READINGS ON IT.

IDEALLY YOU READ THE READINGS 

PRIOR TO THE SESSION SO YOU HAVE

A LITTLE BIT OF BACKGROUND.

THERE ARE READINGS THAT ARE BOTH

IN A BOOK THAT CAME OUT OF OUR 

DEPARTMENT, THE BOOK IS 

ENTITLED -- I DIDN'T BRING A 

COPY.

I APOLOGIZE.

ETHICAL AND REGULATORY ASPECTS 

OF CLINICAL RESEARCH READINGS 

AND COMMENTARY.

IT WAS PUBLISHED IN RELATION TO 

THIS COURSE.

IN ADDITION WE HAVE PROVIDED 

EACH OF YOU WITH A C.D. WHICH 

HAS ADDITIONAL READINGS THAT ARE

NOT IN THE BOOK.

THE BOOK IS BEING UPDATED BUT IT

IS STILL NOT READY YET FOR THE 

NEXT EDITION.

SOME PEOPLE ARE INTERESTED IN 

CREDITS FOR THIS COURSE.

EVERYONE WILL GET A CERTIFICATE 

WHICH VERIFIES THE NUMBER OF 

SESSIONS YOU ATTENDED FOR YOUR 

WORKPLACE IF YOU ARE INTERESTED 

IN C.E.U.s THROUGH THE MARYLAND 

NURSE'S ASSOCIATION, THOSE ARE 

AVAILABLE.

SOME ARE WORKING THROUGH 

CERTIFICATES, WHICH REQUIRES 

OTHER COURSES.

IF YOU ARE INTERESTED IN THAT 

ASPECT OF THIS COURSE, OUR 

REQUIREMENT IS SIGN IN, FILL OUT

THE EVALUATIONS AND ATTEND AT 

LEAST SIX OUT OF THE SEVEN 

SESSIONS.

ALSO FOR THE REMOTE WATCHERS, 

THERE IS AN E-MAIL ADDRESS AT 

THE BOTTOM.

I APOLOGIZE, IT JUST CHANGED IN 

THE LAST MINUTE.

THAT IS THE E-MAIL ADDRESS WHERE

YOU CAN SEND QUESTIONS.

WE WILL GET BACK TO YOU AS SOON 

AS WE CAN.

IN OTHER WORDS, IT MIGHT NOT BE 

REAL-TIME, I CAN'T ANSWER THE 

QUESTIONS AS I'M STANDING UP, 

BUT WE WILL ANSWER YOUR 

QUESTIONS.

WITH THAT HOUSEKEEPING, I WILL 

PLUNGE INTO THE FIR$ 

SUBSTANTIVE TALK UNLESS SOMEBODY

HAS QUESTIONS ABOUT LOGISTICS OR

THE COURSE ITSELF.

OK.

SO I'M GOING TO START BY 

ADDRESSING THE QUESTION OF WHAT 

MAKES CLINICAL RESEARCH ETHICAL.

THE GOAL OF THIS TALK IS TO GIVE

A BROAD FRAMEWORK FOR HOW TO 

THINK ABOUT THE ETHICS OF 

CLINICAL RESEARCH AND MOST OF 

THE THINGS THAT I'M GOING TO 

TALK ABOUT YOU WILL HEA

ABOUT IN THE COURSE OF THE SEVEN

WEEKS IN MORE DEPTH.

I WILL TRY TO POINT OUT SOME OF 

THOSE AS WE GO ALONG.

THIS IS A DISCLAIMER YOU WILL 

SEE PROBABLY FREQUENTLY.

I WORK FOR THE NIH, THE VIEWS 

EXPRESSED ARE MY OWN.

I WILL TALK ABOUT A FEW CENTRAL 

ETHICAL CHALLENGES IN CLINICAL 

RESEARCH.

POINT TO A FEW HISTORICAL 

EXAMPLES WHICH DIRECTED US TO 

THINKING ABOUT ETHICS IN A 

CERTAIN WAY AND PRESENT A 

FRAMEWORK THAT WE IN OUR 

DEPARTMENT HAVE DEVELOPED WHICH 

HAS, I THINK, PROVIDES A USEFUL 

WAY OF THINKING ABOUT HOW TO 

ASSESS THE ETHICS OF A 

PARTICULAR TRIAL.

SO TO START WITH -- CAN YOU HEAR

ME IF I'M NOT NEAR THAT MIC?

I HAVE TO STAY HERE.

TO START WITH, I WANT TO POINT 

TO -- THIS WAS ABOUT A YEAR AGO,

ACTUALLY, IN "THE NEW YORK 

TIMES" ON A SUNDAY.

A BIG ARTICLE ABOUT THE ETHICS 

RESEARCH.

THE TITLE WAS "NEW DRUGS STIR 

DEBATE ON THE RULES OF CLINICAL 

TRIAL."

I PULLED OUT TWO SMALL QUOTES 

FROM THE ART KEL TO -- THE 

ARTICLE TO SHOW YOU THE TENSION 

BETWEEN THE MEDIA AND PUBLIC AND

RESEARCHERS FEEL.

DEFENDERS SAY THEY'RE CRUCIAL TO

DETERMINING WHETHER DRUG DOES 

EXTEND LIFE WITHOUT THE HARD 

PROOF TRIALS CAN PROVIDE, 

DOCTORS ARE LEFT WITH PROVIDING 

UNSUBSTANTIATED HOPE IN THE 

SYSTEM.

ON THE OTHER SIDE, CRITICS SAY 

THE NEW SCIENCE BEHIND DRUGS HAS

ECLIPSED THE OLD RULES AND 

ETHICS OF TESTING THEM.

THEY SAY THAT IN SOME CASES 

DRUGS UNDER DEVELOPMENT MAY BE 

SO MUCH MORE EFFECTIVE THAN 

THEIR PREDECESSORS THAT PUTTING 

HALF OF THE POTENTIAL 

BENEFICIARIES IN THE CONTROL 

GROUP AND DELAYING THE DRUG TO 

THOUSANDS OF OTHER PATIENTS 

CAUSES PAIN AND SUFFERING.

I THINK YOU WILL SEE OVER THE 

COURSE OF THIS MORNING, EVEN, 

THIS IS A TENSION THAT HAS BEEN 

AROUND FOR A LONG TIME.

THIS IS A TENSION STRUGGLED WITH

IN CLINICAL RESEARCH FROM THE 

BEGINNING.

THERE IS ALSO MEDIA ATTENTION 

THAT SUGGESTS THAT RESEARCH IS A

RISKY BUSINESS.

THIS WAS IN "TIME" MAGAZINE A 

FEW YEARS AGO THAT TALKED ABOUT 

HUM

HUMAN GUINEA PIGS.

IT IS VIEWED AS THIS IS RISKY, 

TRYING TO MAKE MONEY FOR 

SOMEBODY ELSE.

AGAIN, I THINK THAT IS A SLANTED

VIEW OF WHAT RESEARCH IS ALL 

ABOUT.

I DO THINK ONE OF THE CENTRAL 

TENSIONS AND MORAL TENSIONS IN 

CLINICAL RESEARCH IS THAT THE 

GOAL OF CLINICAL RESEARCH IS TO 

GENERATE KNOWLEDGE, USEFUL 

KNOWLEDGE ABOUT HUMAN HEALTH AND

ILLNESS.

THE GOAL OF RESEARCH IS NOT TO 

BENEFIT PARTICIPANTS IN THE 

STUDY.

ALTHOUGH, OFTEN PARTICIPANTS DO 

BENEFIT FROM BEING IN RESEARCH.

THAT IS NOT THE GOAL.

IT SETS UP THE PROBLEM WHERE 

PEOPLE ARE THE MEANS FOR 

DEVELOPING USEFUL KNOWLEDGE AND 

THEREFORE AT RISK OF BEING 

EXPLOITED IN THE CONTEXT OF 

RESEARCH.

I THINK CENTRALLY TO 

UNDERSTANDING RESEARCH IS 

RECOGNIZING THE DIFFERENCE 

BETWEEN CLINICAL RESEARCH AND 

CLINICAL CARE.

HOW MANY OF YOU WORK HERE AT THE

NIH?

OK.

SO WE CONDUCT CLINICAL RESEARCH 

HERE IN THE CLINICAL CENTER 

WHICH LOOKS LIKE, FEELS LIKE, 

SMELLS LIKE A HOSPITAL.

MANY OF THE PEOPLE THAT ARE 

DOING RESEARCH ARE DOCTORS.

PATIENTS ARE TAKEN CARE OF BY 

NURSES, SOCIAL WORKERS, I MEAN 

THIS IS A HOSPITAL THAT LOOKS 

LIKE ANY OTHER HOSPITAL 

ANYWHERE.

BUT CLINICAL RESEARCH IS 

DIFFERENT THAN CLINICAL CARE IN 

MANY CENTRAL WAYS.

THE GOALS OF RESEARCH ARE 

GENERATION OF USEFUL KNOWLEDGE 

ABOUT HEALTH.

THE GOALS OF CLINICAL CARE ARE 

TO DO WHAT IS BEST FOR THE 

PATIENT IN FRONT OF YOU.

THOSE GOALS CAN BE IN CONFLICT.

THERE ARE ALSO DIFFERENT METHODS

OF CLINICAL RESEARCH YOU 

WOULDN'T SEE IN CLINICAL CARE.

IT WOULD BE UNUSUAL TO GO TO A 

DOCTOR FOR AN ILLNESS FOR 

TREATMENT AND THE DOCTOR TO SAY 

I WILL RANDOMIZE YOU TO THIS 

DRUG OR THAT DRUG AND NEITHER 

YOU NOR I WILL KNOW WHAT YOU 

WILL TAKE.

THAT WOULDN'T HAPPEN IN CLINICAL

PRACTICE AND THAT IS YET A 

COMMON DESIGN IN CLINICAL 

RESEARCH.

THERE ARE ALSO RISKS IN CLINICAL

RESEARCH.

IN CLINICAL PRACTICE WHEN PEOPLE

ARE DIAGNOSED, THERE ARE 

CERTAINLY RISKS, THERE ARE RISKS

TO DRUGS, PROCEDURES, ET CETERA.

THOSE RISKS ARE JUSTIFIED BY THE

POSSIBLE BENEFITS THAT THE 

INDIVIDUAL WILL GET FROM FINDING

OUT WHAT THEY HAVE, TREATING 

THEIR ILLNESSES.

IN RESEARCH, WE ADD RISKS THAT 

ARE NOT JUSTIFIED BY 

COMPENSATORY BENEFITS TO 

INDIVIDUAL SUBJECTS, BUT RATHER 

JUSTIFIED BY THE VALUE OF THE 

KNOWLEDGE.

SO THERE MAY BE AN EXTRA BIOPSY 

OR EXTRA BLOOD DRAW OR EXTRA 

PROCEDURE OF SOME SORT.

THAT IS TOTALLY DONE FOR 

RESEARCH PURPOSES AND NOT FOR 

THE BENEFIT OF THE INDIVIDUALS.

SO WE CAN LEARN A LOT ABOUT HOW 

WE THINK OF RESEARCH BY LOOKING 

HISTORICALLY.

SUSAN LEDERER, WHO IS A 

HISTORIAN WILL SPEAK ABOUT THIS 

IN DETAIL.

I WANT TO FRAME HISTORY OF THE 

WAY WE THINK ABOUT RESEARCH 

TODAY.

OVER THE COURSE OF TIME, WE HAVE

GONE THROUGH AT LEAST FIVE 

DIFFERENT PERIODS.

THE FIRST IS HUNDREDS OF YEARS 

WHERE THERE WERE FEW RULES MOST 

TREATMENTS WERE EXPERIMENTAL.

THEY EXPERIMENTED FOR THE 

BENEFIT OF THE INDIVIDUAL IN 

FRONT OF THEM OR OUT OF 

CURIOSITY OR HAD EXTRA RESOURCES

AND THOUGHT IT WAS INTERESTING.

WE WENT THROUGH WHAT WAS CALLED 

THE UTILITARIAN ERA OF RESEARCH,

WHERE THE EMPHASIS WAS ON 

BENEFIT TO SOCIETY.

THESE ARE IMPORTANT QUESTIONS 

THAT WE NEED TO ANSWER FOR 

SOCIETY.

PEOPLE SHOULD STEP UP TO THE 

PLATE AND CONTRIBUTE TO 

ANSWERING THOSE QUESTIONS.

DURING THAT PERIOD OF TIME, 

THERE WERE MANY OF 

USING CAPTIVE, AVAILABLE, 

VULNERABLE PEOPLE TO ANSWER 

QUESTIONS.

FOR EXAMPLE, PRISONERS, ORPHANS,

PEOPLE IN MENTAL INSTITUTIONS.

THAT LED TO EXPOSURE OF SOME OF 

THE EXPERIMENTS THAT PEOPLE 

FOUND TROUBLING, LED TO A PERIOD

THAT I CALL A PERIOD OF 

EXAMINATION OF SCOPE AND 

LIMITATIONS OF RESEARCH.

WHAT IS THE PROPER WAY TO THINK 

ABOUT WHAT RESEARCH SHOULD DO 

AND WHAT THE LIMITATIONS SHOULD 

BE.

AND THEN THAT LED TO A SET OF 

RULES AND REGULATIONS THAT WE 

STILL OPERATE UNDER WHERE THE 

EMPHASIS IS PROTECTION OF THE 

HUMAN SUBJECT.

PROTECTION OF SUBJECT FROM RISK 

AND EXPLOITATION.

SOME ARGUE THAT IN MORE RECENT, 

MAYBE THE LAST DECADE OR SO, TWO

DECADES, A SORT OF PENDULUM 

SWING OF RECOGNIZING RESEARCH AS

BENEFICIAL.

AND THAT PEOPLE, NOT ONLY FOR 

THE INDIVIDUALS THAT MIGHT 

PARTICIPATE IN THE RESEARCH, BUT

THE POPULATIONS THEY REPRESENT.

SO THERE IS A SORT OF LITTLE BIT

OF A SHIFT TOWARD RECOGNIZING 

THE BENEFIT OF RESEARCH AS 

OPPOSED TO PROTECTING AGAINST 

THE RISK.

I WILL GIVE YOU A FEW EXAMPLES 

IN SOME OF THESE.

STARTING WITH THESE FEW RULES.

I HAVE A COUPLE OF INTERESTING 

EARLY TRIALS.

A BRITISH NAVY SURGEON ON A BOAT

IN A CHANNEL.

IN 1747, HE DID A STUDY WHERE HE

EVALUATED SIX DIFFERENT 

INTERVENTIONS FOR SAILORS 

BECAUSE HE WAS WORRIED ABOUT THE

TREATMENT OF SCURVY.

THIS IS AN IMPORTANT PROBLEM.

HE HAD AN IDEA OF HOW TO STUDY 

IT.

THINK ABOUT IT, SIX 

INTERVENTIONS IN 12 SAILORS 

WASN'T GOING TO GIVE HIM TOO 

MUCH INFORMATION.

THE WORD LIMY FOR BRITISH 

SAILORS CAME OUT OF SOME OF THE 

WORK THAT LYNN DID.

ANOTHER EXAMPLE SOME OF YOU MAY 

BE FAMILIAR WITH IS SEMELWEIS 

WHO NOTICED THE DEATH IN 

DIFFERENT OB-GYN CLINICS.

HE WAS ABLE TO CONCLUDE THAT THE

DIFFERENCE IN TERMS OF RATE OF 

DEATH WAS THE TYPE OF 

PRACTITIONER.

THAT THE MIDWIVES HAD A MUCH 

HIGHER SUCCESS RATE OF KEEPING 

PEOPLE ALIVE AND NOT GETTING THE

FEVER THAN THE OBSTETRICIANS.

HE FURTHER PROVED THAT THIS WAS 

RELATED TO HAND WASHING.

AND LATER SHOWED THAT THE USE OF

CHLORINATED LIME TO STERILIZE 

HANDS SIGNIFICANTLY REDUCED THE 

RATE OF PURPLE FEVER.

INTERESTINGLY, HE WAS RIDICULED 

FOR THIS WORK.

NOBODY BELIEVED HIS FINDINGS AND

NOBODY BELIEVED HIS RESULTS AND 

HE DIED, HIMSELF, IN A MENTAL 

INSTITUTION.

THIS STUDY, NOT TOO LONG 

THEREAFTER, IN THE 1890s MAY 

HAVE BEEN ONE OF THE EARLIEST 

RANDOMIZED KRIEL-STYLE STUDIES 

IN A HOSPITAL.

THIS IS FOR THE ANTIDIPTHERIA 

THER UM.

THEY RANDOMIZE PATIENTS TO 

RECEIVE STANDARD TREATMENT OR 

THE DIPHTHERIA SERUM.

THEY FOUND IT DID REDUCE DEATH.

AND THEN THERE COULD BE LOTS OF 

DISPUTE OF WHAT COUNTS IN THIS 

ERA.

SHE'S PROBABLY LAUGHING AT ME.

SAM ARELI WAS WORKING ON THIS 

BAD PROBLEM OF YELLOW FEVER.

HE DID AN EXPERIMENT WHERE HE 

REDUCED YELLOW FEVER IN PATIENTS

BY EXPOSING THEM TO CONTAMINATED

MOSQUITOS.

HE WAS DENOUNCED BY A DOCTOR.

UNLESS YOU OBTAIN THE SANCTION 

IS [INDISCERNIBLE] 

YOU WILL HEAR ABOUT OTHERS LIKE 

THAT, THAT HAPPENED 

SUBSEQUENTLY.

RIGHT AFTER HIS EXPERIMENT, THE 

U.S. CREATED THE FAMOUS YELLOW 

FEVER BOARD THE WALTER REED„i 

EXPERIMENTS.

WALTER REED HAS BEEN 

SUBSEQUENTLY PRAISED FOR HAVING 

SEVERAL DETAILS IN HIS STUDY 

THAT WE THINK ARE IMPORTANT TO 

ETHICAL RESEARCH TODAY.

THEY INCLUDED 

SELF-EXPERIMENTATION, WRITTEN 

AGREEMENTS WITH THE OTHER 

SUBJECTS, PAYMENT TO SUBJECTS IN

GOLD, RESTRICTIONS TO ADULTS, NO

CHILDREN AND USING THE PHRASE 

"WITH HIS FULL CONSENT" IN ALL 

THE PUBLICATIONS THAT ENSUED.

THE TWO PICTURES, WALTER REED IS

ON THE LEFT.

HE IN FACT DID NOT 

SELF-EXPERIMENT.

MANY THINK HE DID, BUT HE 

DIDN'T.

THE GUY ON THE RIGHT IS JESSE 

MINNARD WHO DID SELF-EXPERIMENT 

AND DIED OF YELLOW FEVER.

THE IMPORTANT PART OF THE 

UTILITARIAN PHASE ARE THE NAZI 

EXPERIMENTS.

I WON'T SAY ANYTHING ABOUT THEM.

I KNOW SUSAN WILL.

THEY'RE PIVOTAL WHEN WE THINK 

ABOUT THE HISTORY OF THE ETHICS 

OF RESEARCH.

THE NAZI EXPERIMENTS, THE 

NUREMBERG TRIALS AND NUREMBERG 

CODE ARE A PART OF THAT HISTORY.

AROUND THE TIME OF NUREMBERG 

STUDIES WERE GOING ON THAT GOT A

FAIR AMOUNT OF ATTENTION.

A STUDY DONE BY THE MEDICAL 

RESEARCH COUNCIL THAT RANDOMIZED

PEOPLE WITH TUBERCULOSIS.

AT THE TIME, IT WAS CRITICIZED 

FOR RANDOMIZING SOME INDIVIDUALS

TO BEDREST.

THIS WAS A TIME IN THE 1940s 

WHEN STUDIES WERE DONE WITH NO 

INFORMED CONSENT.

NONE OF THE INDIVIDUALS KNEW 

THEY WERE PART OF THE STUDY.

YET THE DATA WAS SIGNIFICANT IN 

SHOWING HOW IT HAD A HUGE IMPACT

ON DEATH AND SURVIVAL AND RADIO 

LOGIC LIVING OF PEOPLE WITH TB. 

>> ONE OF THE EXAMPLES IS THE 

POLIO SOFT VACCINE TRIALS IN 

1954.

THERE WERE ALMOST TWO MILLION 

CHILDREN INVOLVED IN THESE 

STUDIES.

THESE WERE FIRST AND SECOND AND 

3RD GRADERS.

SO WE THINK ABOUT DOING A STUDY 

TODAY WITH 2 MILLION CHILDREN, I

DON'T THINK IT WILL HAPPEN.

THIS IS A STUDY WHICH RANDOMIZED

THE KIDS IN A COMPLICATED 

DESIGN, WHICH I WON'T GET INTO.

SOME GOT POLIO VACCINE, SOME 

PLACEBO AND SOME GOT NONE.

THE VACCINE WAS EFFECTIVE 

AGAINST PARALYTIC, BUT NO EFFECT

AGAINST NONPARALYTIC.

I MENTIONED THIS SAN ERA WHERE 

LOTS OF RESEARCH WAS DONE IN 

PRISON.

I WON'T SAY ANY MORE ABOUT THAT.

I WILL SWITCH TO ANOTHER AREA.

BEACHER WAS AT HARVARD AND 

PUBLISHED A PAPER IN 1956 WHICH 

WAS LANDMARK IN TERMS OF 

EXPOSING EXPERIMENTS THAT HE 

THOUGHT WERE EGREGIOUS AND 

WRONG.

HE DESCRIBED THEM AS THESE ARE 

EXAMPLES IN WHICH THE PATIENTS 

NEVER HAD THE RISKS SATISFIERLY 

EXPLAINED TO THEM.

THERE ARE SOME THINGS THAT WERE 

IMPORTANT.

THESE WERE INSTITUTIONS OF GREAT

REPUTE.

JOHNS HOPKINS, HARVARD OR HERE 

AT THE NIH.

THESE WERE NOT, YOU KNOW, RANDOM

STUDIES THAT PEOPLE WERE DOING 

THAT WEREN'T ON THE RADAR 

SCREEN.

THESE WERE IMPORTANT STUDIES 

BEING DONE BY REPUTABLE PEOPLE, 

PUBLISHED IN REPUTABLE JOURNALS.

ALSO, I THINK IT IS NOTABLE THAT

HE TALKS ABOUT THE FACT THAT 

THEY DIDN'T KNOW ABOUT THEM, 

THEY WEREN'T EXPLAINED TO THEM.

SOME OF THEM ARE QUESTIONABLE 

WITH RESPECT TO THE AMOUNT OF 

RISK THEY POSED AS WELL.

THESE ARE A COUPLE OF EXAMPLES.

WITHHOLDING ANTIBIOTICS FROM 

MEN.

TRANSPLANTING MELANOMA FROM A 

DAUGHTER TO HER MOTHER WHO THEN 

DIED A YEAR AND A HALF LATER 

FROM MELANOMA.

OF COURSE, I LANDMARK STUDY IN 

THIS HISTORY, WHICH EVERYONE I 

ASSUME IN THIS ROOM HAS HEARD 

ABOUT IS THE TUSKEGEE STUDY.

SUSAN WILL TALK ABOUT THIS IN 

MORE DEPTH.

IT IS CRITICAL FOR A COUPLE OF 

REASONS.

IT IS IN THIS PERIOD OF 

EXAMINATION OF SCOPE AND 

LIMITATION, THE EXPOSURE OF THE 

TUSKEGEE STUDY LED TO A SERIES 

OF EVENTS THAT CHANGED HISTORY.

IT LED TO THE PROGRESSAL 

CREATION OF THE NATIONAL 

RESEARCH ACT AND NATIONAL 

COMMISSION OF THE SUBJECTS OF 

RESEARCH.

THE RESEARCH ACT THAT THE U.S. 

CONGRESS PASSEDA AND THE 

SUBSEQUENT WORK OF THE 

COMMISSION HAD A HUGE IMPACT OF 

HOW WE THINK ABOUT RESEARCH 

ETHICS TODAY AND HOW IT HAS BEEN

SHAPED SINCE THE 1970s.

ONE OF THE IMPORTANT DOCUMENTS 

THAT THE NATIONAL COMMISSION 

PUBLISHED WAS THE BELMONT 

REPORT, WHICH IS VERY -- I LIKE 

TO DESCRIBE IT AS SHORT AND 

CLEAR.

I RECOMMEND IT TO ANYONE WHO 

HASN'T READ IT, BECAUSE IT DOES 

A NICE JOB OF EXPLICATING THREE 

PRINCIPLES WHICH UNDERLIE THE 

CONDUCT OF RESEARCH AND APPLYING

THEM TO SPECIFIC ASPECTS OF 

RESEARCH, WHICH IS USEFUL AS 

WELL.

SO THE WORK OF THE NATIONAL 

COMMISSION LED TO, AS I 

MENTIONED, A NEW ERA IN TERMS OF

THINKING ABOUT RESEARCH ETHICS.

THAT IS PROTECTION OF HUMAN 

SUBJECTS.

A NUMBER OF RULES AND 

REGULATIONS THAT ARE NOW IN 

PLACE TO HELP US PROTECT HUMAN 

SUBJECTS.

NOW, WE OPERATE UNDER A NUMBER 

OF REGULATIONS FROM THE U.S. 

GOVERNMENT TO COMMON RULE.

THE SUBPARTS 245 CFR 46 AND 

F.D.A. REGULATIONS.

YOU WILL HEAR MORE ABOUT THESE 

LATER TODAY FROM OUR THIRD 

SPEAKER.

YOU WILL HEAR THEM REFERENCED 

THROUGHOUT THE COURSE, 

ESPECIALLY I THINK THE COMMON 

RULE.

THERE ARE ALSO A NUMBER OF CODES

AND GUIDELINES THAT HAVE BEEN 

DEVELOPED SINCE THE BELMONT 

REPORT.

I HAVE THE BELMONT REPORT ON 

THIS SLIDE.

MANY OF THEM BUILD ON THE WORK 

THAT THE BELMONT REPORT STARTED.

AND DO A LOT OF INTERESTING 

THINGS IN TERMS OF SPECIFYING 

MORE PARTICULAR REQUIREMENTS FOR

RESEARCHERS AND RESEARCH 

REVIEWERS.

SO NOW, I WANT TO TURN TO -- OK,

SO LOTS OF HISTORY, LOTS OF 

INTERESTING QUESTIONS GENERATED.

LOTS OF INTERESTED EXAMPLES THAT

HAVE RAISED IMPORTANT QUESTIONS 

IN TERMS OF THINKING ABOUT THE 

ETHICS OF RESEARCH.

AND A NUMBER OF RULES AND CODES 

IN PLACE THAT HELP GUIDE 

RESEARCH.

SO I DON'T KNOW, A LITTLE MORE 

THAN 10 YEARS AGO, SOME OF US IN

THE DEPARTMENT HERE AT THE NIH 

THOUGHT ABOUT THIS ISSUE OF DO 

INVESTIGATORS AND RESEARCH TEAMS

THAT ARE OUT THERE TRYING TO 

FIGURE OUT WHAT MAKES CLINICAL 

RESEARCH ETHICAL REALLY HAVE A 

GOOD HANDLE ON IT, DESPITE ALL 

THE PLETHORA OF RULES AND 

GUIDELINES, THERE SEEMS TO BE A 

PATCHWORK OF GUIDELINES AND 

REGULATIONS.

PERHAPS UNDERSTANDABLE BECAUSE 

MANY OF THEM, IF NOT MOST OF 

THEM, WERE DEVELOPED IN RESPONSE

TO SOME OF THE HISTORICAL 

EVENTS.

SO THEY HAVE FOCUSED ON THE 

PARTICULAR EVENT THAT 

DEMONSTRATED THE NEED FOR THEM.

AND THEN FOCUSED ON THAT AS THE 

MAIN PROTECTION.

IN ADDITION, SOME OF THE 

GUIDANCES HAVE DIVERGENT 

RECOMMENDATIONS.

THEY DON'T ALL AGREE ON EVERY 

ASPECT OF WHAT IS RIGHT.

THERE ALSO, PERHAPS MORE 

IMPORTANTLY DIFFERENCES ON 

INTERPRETATIONS, HOW PEOPLE 

INTEROPERAPRETED WHAT WAS GUIDED

QUITE A BIT.

THERE WAS A NEED FOR SYSTEMIC, 

COHERENT FRAMEWORK.

AND PUT TOGETHER A LIST OF WHAT 

WAS INITIALLY SEVEN THEN BECAME 

EIGHT PRINCIPLES.

I WILL TALK ABOUT THESE BRIEFLY 

WITH EXAMPLES AND CHALLENGES IN 

TERMS OF HOW THEY MIGHT APPLY.

THE EIGHT ARE COLLABORATIVE 

PARTNERSHIP, VALUABLE SCIENTIFIC

QUESTIONS, VALID SCIENTIFIC 

METHODOLOGY, FAIR SUBJECT 

SELECTION, FAVORABLE RISK 

BENEFIT, INDEPENDENT REVIEW, 

INFORMED CONSENT AND RESPECT FOR

ENROLLED SUBJECTS.

THE FRAMEWORK WAS DELIBERATELY 

WRITTEN IN A WAY THAT THESE ARE 

IN ORDER.

SO„i YOU HAVE TO START AT THE
TOP 

AND WORK YOUR WAY DOWN.

AND WE ARGUE THAT THESE ARE NOT 

ONLY SYSTEMATIC BUT UNIVERSAL IN

THEIR APPLICABILITY.

SO WHAT IS THE FIRST ONE?

ETHICAL CLINICAL RESEARCH SHOULD

BE A COLLABORATIVE PARTNERSHIP.

IT SOUNDS SELF-EVIDENT, BUT IT 

ISN'T.

IT IS NEVER AN ISOLATED 

ACTIVITY.

THERE ARE OFTEN MULTIPLE 

COLLABORATORS IN TERMS OF 

CONDUCTING THE STUDY, BUT THERE 

ARE ALSO PARTICIPANTS THAT 

DESERVE COLLABORATIONS, 

COMMUNITY OF PATIENTS THAT 

DESERVE COLLABORATION.

AND CERTAINLY, IF THE GOAL OF 

DEVELOPING GENERALIZABLE 

KNOWLEDGE IS TO ULTIMATELY 

INCORPORATE IT INTO THE HEALTH 

CARE SYSTEM, THEN THERE SHOULD 

BE COLLABORATIVE PARTNERSHIPS 

WITH THE HEALTH CARE SYSTEM AS 

WELL.

SO THIS PRINCIPLE SUGGESTS THERE

SHOULD BE COLLABORATION INTO THE

INTEGRATING RESULT INTO THES 

HEALTH CARE SYSTEM, 

DEMONSTRATION OF RESPECT OF 

CONTRIBUTIONS OF ALL PARTNERS IN

THE ENDEAVOR.

HOW DO COLLABORATIVE 

PARTNERSHIPS GET DONE, 

BASICALLY?

CERTAINLY THERE ARE MULTIPLE 

WAYS.

PLANNING WITH POLICYMAKERS AND 

MEMBERS OF THE HEALTH SYSTEM IN 

VARIOUS LOCALES, JURISDICTIONS.

WAYS TO INCORPORATE THE 

COMMUNITY THROUGH COMMUNITY 

ADVISORY BOARDS.

LAY MEMBERS OF IRB.

ADVOCATES FOR RESEARCH FUNDING, 

COLLABORATING INVESTIGATORS, 

INFORMATION FOR PRACTICING 

CLINICIANS, LOTS OF OTHER WAYS.

THE IDEA BEING THAT THIS IS A 

COLLABORATIVE ACTIVITY AND THERE

NEEDS TO BE RESPECT FOR ALL THE 

COLLABORATORS AND ENGAGEMENT OF 

ALL THE COLLABORATORS IN AN 

ETHICAL RESEARCH PROJECT.

I THINK THE AIDS ACTIVISTS IN 

THE 80s IN PARTICULAR TAUGHT US 

A LOT ABOUT ENGAGING THE 

COMMUNITY IN THIS PARTNERSHIP.

THROUGH DEMANDS TO BE INVOLVED 

IN THE DESIGN AND CONDUCT OF 

RESEARCH, COMMUNITY ENGAGEMENT 

COMMUNITY PARTICIPATION AND 

DEVELOPMENT OF COMMUNITY 

ADVISORY BOARDS HAS BECOME A 

STANDARD IN MANY AREAS OF 

RESEARCH.

THE SECOND PRINCIPLE IS VALUABLE

SCIENTIFIC QUESTION.

THIS, AGAIN, I THINK WILL BE 

SELF-EVIDENT, BUT IF WE ARE 

ASKING SOMEONE TO GENERATE 

KNOWLEDGE, THEN WE SHOULD BE 

SURE THE KNOWLEDGE IS USEFUL.

THAT IS WHAT THIS IS ABOUT.

THE QUESTION YOU ARE ASKING HAS 

TO BE VALUABLE.

ONE THAT WILL GENERATE NEW 

KNOWLEDGE OR UNDERSTANDING ABOUT

HUMAN HEALTH OR ILLNESS THAT IS 

SOCIALLY, CLINICALLY OR 

SCIENTIFICALLY USEFUL.

THEN THERE ARE LOTS OF 

QUESTIONS, VALUABLE TO WHO?

TO WHERE PEOPLE LIVE, TO FUTURE 

PEOPLE, PEOPLE WITH THIS DISEASE

AND WHO GETS TO DECIDE HOW 

VALUABLE AND HOW?

THESE ARE CHALLENGES THAT I 

THINK PEOPLE STRUGGLE WITH ALL 

THE TIME.

I LIKE TO GIVE YOU ONE EXAMPLE.

THIS IS AN EXAMPLE I THINK 

ILLUSTRATES HOW DIFFICULT IT IS 

TO AGREE ON WHAT SOCIAL VALUABLE

MEANS IN PRACTICE.

THIS IS A PHASE 3 TRIAL OF THE 

AN

ANTI-H.I.V. VACCINE TRIALS IN 

THAILAND.

THERE WERE ONLY A FEW OF THESE 

DONE.

THIS IS A TRIAL OF A TRIBOOST 

COMBINATION.

I THINK UNUSUALLY, PRIOR TO THE 

BEGINNING OF THE TRIAL THERE 

WERE A SERIES OF ARTICLES IN 

SCIENCE MAGAZINE DEBATING 

WHETHER THIS WAS A TRIAL WORTH 

DOING, WAS IT VALUABLE ENOUGH.

THERE WERE SOME THAT ARGUED THAT

THE DATA FROM THE EARLIER TRIAL 

SUGGESTED THAT THIS WAS NOT 

GOING TO BE A VALUABLE TRIAL TO 

DO.

IT WAS A WASTE OF RESOURCES AND 

A WASTE OF PEOPLE'S EXPOSURE TO 

RISK, ET CETERA, AND SHOULDN'T 

BE DONE.

OTHERS ARGUED THE OPPOSITE, THE 

PREVIOUS DATA SUPPORTED FINDING 

OUT WHETHER THERE WAS PROTECTIVE

EFFECT AND THAT THE RESOURCES 

WERE WORTH SPENDING IN THIS WAY.

SO IF YOU ARE INTERESTED IN THIS

DEBATE, IT WAS REALLY QUITE 

PUBLIC AND DRAMATIC IN THE PAGES

OF SCIENCE MAGAZINE.

IT WAS BASICALLY DEBATING, 

WHETHER THERE WAS SPECIFIC 

SCIENTIFIC VALUE.

INTERESTINGLY, SIX, FIVE YEARS 

LATER WHEN THE STUDY WAS ENDED, 

THIS DEBATE OCCURRED AGAIN.

IT OCCURRED AGAIN BECAUSE OF THE

RESULTS OF THE TRIAL.

THIS TRIAL WAS SHOWN TO BE 

30-SOMETHING PERCENT EFFECTIVE.

THE VACCINE CANDIDATE IN 

PREVENTING H.I.V. INFECTION.

THERE WERE A LOT OF DISPUTES, 

FIRST OF ALL, CAN YOU TRUST THE 

NUMBER, SECOND OF ALL, WHAT DOES

IT MEAN IN TERMS OF MOVING 

FORWARD IN H.I.V. DEVELOPMENT.

THE INTERESTING DEBATE ABOUT 

CLINICAL RESEARCH IN A 

PARTICULAR CASE OR STUDY.

YOU HAVE COLLABORATIVE 

PARTNERSHIP IN A USEFUL, 

VALUABLE SCIENTIFIC QUESTION.

THE NEXT ETHICAL REQUIREMENT IS 

TO DESIGN YOUR STUDY IN A WAY 

THAT YOU GET AN INTERPRETABLE 

ANSWER TO THE QUESTION.

IT DOESN'T MEAN IT HAS TO BE A 

POSITIVE ANSWER, IT HAS TO BE AN

INTERPRETABLE ANSWER.

THERE IS A LOT PACKED INTO THIS 

PARTICULAR REQUIREMENT.

AND ARGUABLY, PEOPLE SAY THAT IS

A SCIENTIFIC REQUIREMENT, YOU 

HAVE TO HAVE GOOD SCIENCE.

SO OUR ARGUMENT HERE IS THAT 

GOOD SCIENCE IS IMPORTANT 

ETHICALLY SO VALID SCIENTIFIC 

METHODOLOGY, DESIGNING THE 

STUDY, CHOOSING THE ENDPOINTS, 

CHOOSING THE PROCEDURES, MAKING 

SURE THE DATA IS MANAGED 

CORRECTLY, STATISTICALLY 

ANALYZING IT IN A RIGOROUS WAY, 

ALL OF THAT IS AN ETHICAL 

REQUIREMENT SO THAT YOU WILL 

HAVE VALID, RELIABLE, 

GENERALIZABLE AND INTERPRETABLE 

DATA AT THE END OF THE STUDY.

THIS, TOO, IS A SERIOUS 

CHALLENGE.

AND IT IS INTERESTING TO THINK 

ABOUT SOME EXAMPLES.

I WAS NOTICING THERE WERE TWO 

ARTICLES IN THE NEW ENGLAND 

JOURNAL OF MEDICINE IN 

SEPTEMBER.

TWO DIFFERENT ISSUES.

BOTH OF THEM WERE TESTING NEW 

DRUGS FOR PEOPLE WITH ATRIAL 

FIBRILLATION.

I WROTE DOWN THE NAMES OF THE 

DRUGS.

ONE IS APIXABAN AND THE OTHER IS

DRIPOROXABAN.

I'M NOT SUGGESTING THERE IS 

ANYTHING WRONG WITH THE STUDIES.

THEY LOOK LIKE THEY'RE ON THE 

UP-AND-UP TO ME.

THEY CHOSE THE ENDPOINTS THAT 

MADE SENSE IN THE SCENARIO.

IS NOT THE ONLY ENDPOINT THAT 

COULD HAVE BEEN CHOSEN.

THERE IS A BIG DEBATE IN SCIENCE

AS SOME OF YOU MAY BE AWARE, 

BETWEEN THE USE OF CLINICAL 

ENDPOINTS AND SURROGATE 

ENDPOINTS FOR CLINICAL TRIALS.

THESE CHOICE OF ENDPOINTS HAVE 

SERIOUS ETHICAL IMPLICATIONS.

CHOICE OF DESIGN HAS HUGE 

IMPLICATION.

THESE WERE RANDOMIZED AND DOUBLE

BLINDED ONE GROUP GOT THE NEW 

DRUG AND THE OTHER GOT MOR 

FORRIN, FOR EXAMPLE.

WHAT IS INTERESTING IS TO LOOK 

AT HOW THE DESIGN WAS PUT 

TOGETHER IN TERMS OF STATISTICS.

IN BOTH CASES OF THESE TWO 

TRIALS, THEY ANALYZED THE DATA 

AS NONINTERIORITY AND 

SUPERIORITY.

IT IS FASCINATING TO SEE THE 

DIFFERENCE IN TERMS OF OUTCOME.

MY POINT FOR YOU TODAY IS THIS 

IS A DECISION THAT IS MADE AT 

THE FRONT END THAT HAS AN 

ETHICAL IMPLICATION TO IT.

THAT IS WHAT KIND OF DESIGN ARE 

YOU GOING TO USE?

CAN YOU USE A DOUBLE-BLIND FOR A

TRIAL?

CAN YOU USE A PLACEBO.

IS IT NONINTERIORITY, IS IT 

SUPERIORITY?

WHAT KIND OF CERTIFICATE OF ARE 

GOING TO USE.

THERE ARE QUESTIONS ABOUT THE 

PROCEDURES, HOW YOU WILL MEASURE

THE OUTCOME, WHAT PROCEDURE YOU 

WILL USE.

WHO WILL DO THEM, WHAT LENGTH OF

FOLLOW-UP WILL YOU HAVE?

THE STUDIES HAD TWO DIFFERENT 

LENGTHS OF FOLLOW-UP IN THE 

PARTICULAR DETAILS OF THEIR 

STUDY.

INTERESTING QUESTIONS ABOUT 

STATIST

STATISTICS, WHAT IS SUFFICIENT 

POWER TO SHOW AN ANSWER TO YOUR 

QUESTION.

WHAT STATISTICAL METHODS WILL 

YOU USE, WHAT LEVELS WILL YOU 

ACCEPT AS THE GOLD STANDARD, AS 

MOST PEOPLE THINK ABOUT LESS 

THAN .05.

THERE IS LOTS OF DEBATE ABOUT 

WHETHER THAT IS THE RIGHT LEVEL 

OF SIGNIFICANCE.

AGAIN, THESE ARE ETHICAL AND 

SCIENTIFIC THINGS.

IN TERMS OF SCIENTIFIC VALIDITY,

NOT ONLY CHOICE OF DESIGN AND 

ENDPOINTS, ET CETERA, BUT 

FEASIBILITY, IF YOU DESIGNi] A 

STUDY WITH A VERY RIGOROUS 

BENIGN AND ENDPOINTS AND ISSUES,

IT IS NOT POSSIBLE TO DO IT 

EITHER BECAUSE PEOPLE WILL NOT 

VOLUNTEER OR YOU DON'T HAVE THE 

RIGHT EQUIPMENT OR YOU CAN'T 

DELIVER THE DATA MANAGEMENT 

TRAINING TO THE STAFF, WHATEVER,

I MEAN, WHATEVER THE REASONS 

THAT A STUDY MIGHT NOT BE 

COMPLETABLE MAKES IT UNETHICAL.

I THINK IT DOES -- SCIENTIFIC 

VALIDITY DOES RAISE OFTEN, THIS 

TENSION THAT I STARTED OUT WITH 

IN THE BEGINNING BETWEEN WHAT IS

THE RIGHT DESIGN TO GET RIGOROUS

GENERALIZABLE KNOWLEDGE THAT IS 

HELPING UNDERSTAND.

WHILE WE ARE ALSO PROTECTING THE

PARTICIPANTS THAT ARE IN THE 

STUDY.

IT OFF COMES IN THE SCIENTIFIC 

DESIGN SECTION.

SO THE NEXT PRINCIPLE IS FAIR 

SUBJECT SELECTION.

SO YOU HAVE A GOOD SCIENCE 

VALUABLE QUESTION AND A REALLY 

WELL-DESIGNED STUDY.

YOU NEED TO FIND PEOPLE TO BE IN

IT.

WE ARGUE THAT SCIENTIFIC 

OBJECTIVES SHOULD BE THE FIRST 

GUIDE FOR INCLUSION CRITERIA AND

RECRUITMENT STRATEGIES.

BUT THEY CAN'T BE THE ONLY 

GUIDE.

SO BASED ON HISTORICAL EXAMPLES 

AND IMPORTANT DISCUSSION THAT 

THE BELMONT REPORT INTRODUCES, 

SCIENTIFIC CRITERIA SHOULD GUIDE

INCLUSION AND NOT PRIVILEGE OR 

EASY AVAILABILITY OR 

VULNERABILITY.

WE SHOULD NOT ENROLL PEOPLE 

BECAUSE THEY'RE CAPTIVE, EASY TO

GET OR WHATEVER OR PRIVILEGED. 

>> ONCE THERE IS A SCIENTIFIC 

DISCUSSION ABOUT WHO IS 

APPROPRIATE TO ENROLL, THERE ARE

STILL IMPORTANT DISCUSSIONS 

ABOUT HOW WE THINK ABOUT THE 

RISKS AND BENEFITS TO THIS 

POPULATION THAT WE HAVE 

IDENTIFIED.

OUR GOAL SHOULD ALWAYS BE TO 

MINIMIZE HARMS AND FAIRLY 

DISTRIBUTE THE BENEFITS.

FOR ALL APPROPRIATE INDIVIDUALS,

WE SHOULD HAVE AN OPEN-ENDED NO 

EXCLUSION UNLESS THERE ARE 

JUSTIFY.

THE JUSTIFICATIONS ARE IN THE 

FORM OF RISK, BENEFIT AND 

VULNERABLEABILITY.

HAVING SAID, THAT I THINK THERE 

IS SOME DEBATE AS I POINTED OUT,

BETWEEN THE EXTENT TO WHICH 

RESEARCH IS A BURDEN FROM WHICH 

SUBJECTS NEED PROTECTION OR 

RESEARCH IS A BENEFIT TO WHICH 

SUBJECTS WANT AND NEED ACCESS.

THIS DECISION ABOUT WHICH IT IS 

AND HOW MUCH OF ONE OR THE OTHER

IT IS, IS ESSENTIAL TO HOW YOU 

COLLECT PARTICIPANTS FOR A 

STUDY.

I THINK THERE IS INTERESTING 

CHALLENGES.

THIS IS, AGAIN, A HISTORICAL 

EXAMPLE.

THIS IS A STUDY DONE IN THE 90s,

JESSIE, MANY OF YOU MAY HAVE 

HEARD OF HIM, HE WAS AN 18, 

19-YEAR-OLD YOUNG MAN WHO HAD A 

LONGSTANDING OTC DEFICIENCY.

AND VOLUNTEERED TO BE PART OF A 

PHASE ONE GENE THERAPY STUDY IN 

PHILADELPHIA.

AND ACTUALLY, HE DIED FROM THE 

STUDY.

THE STUDY LEFT -- LED TO A LOT 

OF QUESTIONS ABOUT THINGS LIKE 

CONFLICTS OF INTEREST, THINGS 

LIKE OVERSIGHT AND REPORTING 

NEGATIVE SIDE EFFECTS.

LOTS OF ATTENTION TO THE STUDY 

FOR A LOT OF DIFFERENT REASONS.

I THINK ONE INTERESTING QUESTION

THAT IS STILL IN MY MIND BEING 

DEBATED ABOUT THIS STUDY AND 

OTHERS LIKE IT, IS THE QUESTION 

OF SUBJECT SELECTION.

BECAUSE THERE ARE -- THIS 

DISEASE HAS TWO FORMS, 

APPARENTLY.

THERE ARE CHILDREN WHO ARE BORN 

WITH OTC DEFICIENCY, WHO HAVE 

THE SEVERE, COMPLETE FORM, I 

THINK IT IS CALLED, USUALLY DIE 

BY THE TIME THEY'RE FIVE YEARS 

OLD OR YOUNGER.

THERE ARE OTHERS THAT HAVE A 

PARTIAL FORM THAT CAN LIVE INTO 

ADULT LIFE BUT HAVE RESTRICTIONS

ON WHAT THEY CAN DO.

THEY HAVE HEALTH PROBLEMS 

THROUGHOUT LIFE.

THEY DON'T DIE AS CHILDREN.

SO THE QUESTION THAT SUGGESTS AN

INTERESTING TENSION IS WHO WOULD

HAVE BEEN AN APPROPRIATE SUBJECT

FOR THIS PHASE ONE, GENE THERAPY

STUDY.

NOW, THE DECISION WAS MADE TO GO

WITH ADULTS WHO CAN CONSENT.

THAT IS A VERY STRONG TRADITION 

TO FAVORING CONSENT OVER OTHER 

CONSIDERATIONS IN TERMS OF 

SELECTION AND SUBJECTS.

THOSE THAT CAN CONVENT ARE LESS 

VULNERABLE BECAUSE THEY MAKE 

THEIR OWN DECISIONS AND PROTECT 

THEIR OWN INTERESTS.

IN THIS CASE, THAT IS WHAT 

HAPPENED.

BUT I HAVE HEARD PEOPLE ASK THE 

QUESTION, IN TERMS OF RISKS AND 

BENEFITS, IS THAT THE RIGHT 

POPULATION?

YOU HAVE CHILDREN WHO WILL DIE 

FROM THIS DISEASE „iANYWAY, IN A

VERY SHORT LIFE, AND THEREFORE 

HAVE A LOT MORE TO GAIN IF IN 

FACT SOMETHING HAPPENS THAT IS 

BENEFICIAL, ARGUABLY OR NOT, 

LESS TO LOSE IF IT DOESN'T.

WOULD THEY HAVE BEEN A BETTER 

CHOICE THAN ADULTS WHO MIGHT 

HAVE GONE ON FOR YEARS WITH SOME

COMPROMISED HEALTH BUT ALIVE?

THE NEXT PRINCIPLE IS FAVORABLE 

RISK BENEFITS.

SO LET ME GET US WHERE YOU ARE.

VALUABLE QUESTIONS, RIGOROUS 

DESIGN, DECIDED WHO TO SELECT, 

WHO TO RECRUIT FOR THE SCIENCE 

IN THE CRITERIA AND A 

CONSIDERATION OF WAYS TO 

MINIMIZE RISKS AND ARMS.

THEN THERE IS AN ADDITIONAL 

TASK, AN IMPORTANT ONE, OF 

MAKING SURE THAT THE RISKS THAT 

ARE IN THE STUDY, AS DESIGNED, 

ARE ABSOLUTELY NECESSARY AND ARE

MINIMIZ

MINIMIZED.

THEN MAKING A DECISION ABOUT 

WHETHER OR NOT THE RISKS TO THE 

INDIVIDUAL IN THE STUDY ARE 

JUSTIFIED.

BY EITHER THE IMPORTANCE OF THE 

KNOWLEDGE TO BE GAINED AND ANY 

POSSIBLE BENEFIT TO THE 

PARTICIPANTS OR JUST THE 

IMPORTANCE OF THE KNOWLEDGE TO 

BE GAINED.

AND I THINK YOU WILL SEE, AS WE 

GO THROUGH THIS COURSE, THAT 

THIS IS AN INTERESTING AND 

CHALLENGING KIND OF BALANCING 

ACT IN TERMS OF FIRST OF ALL, 

IDENTIFYING WHAT THE POTENTIAL 

RISKS AND BENEFITS ARE, AND THEN

MAKING THIS SORT OF CALCULATED 

DECISION, JUDGMENT ABOUT WHETHER

THE RISKS ARE JUSTIFIED BY OTHER

CONSIDERATIONS LIKE THE VALUE OF

THE KNOWLEDGE.

I THINK IT IS IMPORTANT THAT WE 

REMEMBER THAT IN RESEARCH, WE 

ACCEPT THE FACT THAT INTERESTS 

OTHER THAN THOSE OF THE SUBJECTS

ARE SOMETIMES SUFFICIENT TO 

JUSTIFY THE RISK.

SO THIS IS A STATEMENT FROM THE 

BELMONT REPORT, WHICH GOES BACK 

TO WHERE I STARTED AND THAT IS 

THE GOAL OF RESEARCH IS 

GENERATING KNOWLEDGE AND 

SOMETIMES WE ASK PEOPLE TO TAKE 

CERTAIN RISKS THAT ARE NOT FOR 

THEIR BENEFIT.

THAT IS HOW WE DO RESEARCH.

AS LONG AS THE SUBJECT'S RIGHTS 

HAVE BEEN PROTECTED.

I WOULD ADD IN THAT SENSE, 

WELFARE.

THE NEXT PRINCIPLE IS 

INDEPENDENT REVIEW.

AND THIS IS BASICALLY A 

PROCEDURAL MECHANISM TO ENSURE 

THAT THE ETHICAL REQUIREMENTS 

HAVE BEEN FULFILLED, THAT CHECK 

THE NATURAL BIASES THAT 

INVESTIGATORS MIGHT HAVE IN 

CONFLICTS AND TO ASSURE THE 

PUBLIC THAT RESEARCH IS NOT DONE

IN A WAY THAT IS HAPHAZARD OR 

EXPLOITING INDIVIDUALS AND 

GROUPS.

SO INDEPENDENT REVIEW IN THE 

UNITED STATES IS DONE PRIMARILY 

THROUGH INSTITUTIONAL REVIEW 

BOARDS OR IRBs.

WE'RE GOING TO HEAR MORE ABOUT 

THEM IN THIS COURSE AND HAVE A 

MOCK IRB SESSION AS WELL.

IN REALITY, WHEN A CLINICAL 

PROTOCOL IS DONE, THERE ARE LOTS

OF LAYERS OF REVIEW.

NOT JUST THE IRB THAT GETS TO 

REVIEW A PROTOCOL.

AND IN REALITY, MANY OF THESE 

OTHER REVIEW GROUPS PAY 

ATTENTION TO SOME OF THE ETHICS 

OF WHAT THE PROPOSAL IS DOING.

IN THE COMMON RULE AND F.D.A. 

REGS, THERE ARE SPECIFIC 

CRITERIA THAT IRBs ARE TO USE 

WHEN THEY JUDGE WHETHER OR NOT A

PARTICULAR STUDY IS ACCEPTABLE.

AND YOU WILL NOTICE THAT SOME OF

THESE ARE VERY SIMILAR TO SOME 

OF THE THINGS THAT I HAVE 

ALREADY TALKED ABOUT.

SUPPOSED TO JUDGE THAT RISKS ARE

MINIMIZED, THAT RISKS ARE 

JUSTIFIED BY ANTICIPATED 

BENEFITS, IF ANY TO THE SUBJECTS

OR THE IMPORTANCE OF THE 

KNOWLEDGE GAINED AND SUBJECTS 

ARE SELECTED AND TREATED FAIRLY 

AND THAT INFORMED CONSENT IS 

ADEQUATE.

WITH THOSE CRITERIA, AN IRB CAN 

DECIDE TO APPROVE A PROPOSED 

RESEARCH STUDY.

THAT BRINGS US TO THE NEXT 

PRINCIPLE, INFORMED CONSENT.

INFORMED CONSENT WITH RESPECT TO

THE NOTION OF INDIVIDUALS, 

ENSURES WHETHER OR NOT THEY WANT

TO PARTICIPATE IN A PARTICULAR 

RESEARCH STUDY AND WHETHER OR 

NOT THEY WANT TO CONTINUE TO 

PARTICIPATE.

AND IDEALLY, THEY DO THIS WITH 

ADEQUATE INFORMATION ABOUT WHAT 

THE STUDY IS, WHY IT IS BEING 

DONE, WHAT IT ENTAILS, THEN THEY

MAKE A DECISION ABOUT WHETHER 

THAT IS COMPATIBLE WITH THEIR 

GOALS, VALUES OR INTERESTS.

INFORMED CONSENT IS UNDERSTOOD 

TO HAVE FOUR PARTS TO IT.

DISCLOSING THE INFORMATION, 

SOMEBODY UNDERSTANDING THE 

INFORMATION, HAVING TO MAKE A 

VOLUNTARY DECISION AND 

AUTHORIZING YOUR CONSENT IN A 

WAY THAT CAN BE TRACKED.

THIS IS AN INTERESTING -- WE 

HAVE TALKED ABOUT CONSENT MANY 

TIMES THROUGH THE COURSE.

EACH PRESENT AN INTERESTING 

CHALLENGE.

THE IDEA OF CONSENT IS PRETTY 

UNIVERSALLY AGREED UPON, AND THE

EXECUTION OF IT IS VERY 

CHALLENGING.

THIS IS A CARTOON JUST TO WAKE 

YOU UP IN CASE YOU ARE ASLEEP.

CONSENT SHOULD NOT LOOK LIKE 

THIS, YOU THINK IN REALITY, 

UNFORTUNATELY, SOMETIMES IT 

DOES.

AND THE 8TH PRINCIPLE IS RESPECT

FOR ENROLLED SUBJECTS WE 

INCLUDED THIS IN THE FRAMEWORK 

FOR THE FOLLOWING REASONS, THAT 

THERE WAS A SENSE FROM SOME OF 

THE REGULATIONS AND CODES OF 

ETHICS BUT MORE IMPORTANTLY FROM

THE WAY PEOPLE TALK ABOUT ETHICS

IN THE HALL BASE OF CLINICAL 

INSTITUTIONS THAT ETHICS IS 

THOUGHT OF, OK, I GET IRB 

APPROVAL AND GET THE SUBJECT TO 

SIGN THE INFORMED CONSENT, DONE!

ETHICS IS DONE.

TOOK CARE OF IT.

I THINK, I HOPE THIS COURSE WILL

HELP ALL OF YOU TO REALIZE THAT 

CAN'T BE RIGHT.

THERE ARE A LOT OF ETHICAL 

OBLIGATIONS ONE HAS PRIOR TO 

GOING TO THE IRB.

IT IS THERE TO CHECK, MAKE SURE 

IN PLACE.

ONCE YOU ENROLL OR PERSON OR 

PERSONS INTO A RESEARCH STUDY, 

THERE ARE CLEARLY LOTS OF 

ETHICAL RESPONSIBILITIES AND 

OBLIGATIONS THAT YOU HAVE FOR 

THOSE INDIVIDUALS.

CERTAINLY, THINGS LIKE PROMOTING

THEIR CONFIDENTIALITY, 

MONITORING WELFARE, RECOGNIZING 

THE RIGHT TO WITHDRAW AT ANY 

TIME, INFORMING PARTICIPANTS AND

FINDINGS AND PLANNING FOR WHAT 

HAPPENS AT THE END OF THE TRIAL.

THESE ARE JUST A FEW.

I THINK THERE ARE OTHERS THAT 

BELONG IN THIS CATEGORY OF HOW 

WE -- OUR RESPONSIBILITY TO SHOW

RESPECT FOR PARTICIPANTS THAT 

ARE IN ENROLLED. 

THERE ARE EIGHT PRINCIPLES.

YOU WILL HEAR THEM AGAIN 

THROUGHOUT THE COURSE.

YOU WILL HEAR SESSIONS ABOUT HOW

TO DESIGN STUDIES, ABOUT RISK 

BENEFIT, ABOUT IRB REVIEW, ABOUT

INFORMED CONSENT, ABOUT SOME OF 

THE WAYS WE SHOULD DEMONSTRATE 

RESPECT FOR ENROLLED SUBJECTS 

THROUGHOUT THE COURSE.

I WANT TO CLOSE BY SAYING THERE 

ARE -- I THINK I MENTIONED ABOUT

IT.

THE EIGHT SYSTEMATIC AND 

SUBSEQUENTIAL.

YOU INFER GET TO THE POINT OF --

NEVER GET TO THE POINT OF 

SYSTEMATIC REQUEST IF YOU DON'T 

HAVE THE INFORMED CONSENT.

MAKE SURE RESEARCH IS ETHICAL.

WE THINK ALL OF THESE ARE 

NECESSARY.

ALTHOUGH WE RECOGNIZE THE 

PRECISE PROCEDURAL REQUIREMENTS 

MAY BE WAVERED.

THERE ARE INSTANCES WHERE 

INFORMED CONSENT IS WAVERED -- 

WAIVED.

THEY'RE ADAPTED AND IMPLEMENTED 

ACCORDING TO THE CONTEXT OF THE 

STUDY.

THE PRINCIPLE APPLIES„i IN EVERY

CASE.

YET, THEY REQUIRE BALANCING AND 

SPECIFICATIONS.

THIS ARE CONFLICTS THAT OCCUR 

BETWEEN PRINCIPLES.

THOSE REQUIRE BALANCING, 

SPECIFICATION AND GOOD JUDGMENT.

ENHANCING SCIENTISTS ABILITY 

SOMETIMES INCREASES RISK.

THERE IS A DEBATE ABOUT WHAT IS 

THE PROPER CONTROL?

WHEN CAN YOU USE PLACEBO?

WHAT IS NECESSARY TO OBTAIN 

CONSENT CAN SOMETIMES 

COMPROMISE.

THESE ARE THINGS THAT NEED TO BE

BALANCED.

IN ORDER TO APPLY THE PRINCIPLE 

TO UNDERSTAND THE PRINCIPLES, 

RECONCILE THE CONFLICTS, MAKE 

INFORMED JUDGMENTS ABOUT ETHICAL

RESEARCH, WHAT WE NEED ARE 

EDUCATED AND INFORMED 

INVESTIGATORS, RESEARCH TEAMS 

IRB MEMBERS.

I HOPING THAT IS WHO YOU ALL ARE

IN THIS ROOM AND BASED ON THE 

KINDS OF INFORMATION YOU GET 

FROM THIS COURSE, BE ABLE TO 

MAKE THESE KINDS OF JUDGMENTS 

AND RESOLVE CONFLICT BETWEEN THE

VARIOUS PRINCIPLES THAT GUIDES 

ETHICAL RESEARCH.

THAT IS MY LAST SLIDE.

WE HAVE A FEW MINUTES FOR 

QUESTIONS, IF ANYBODY HAS 

QUESTIONS OR COMMENTS.

YES, PLEASE.

IF YOU CAN USE THE MIC, THAT 

WOULD BE GREAT.

SO EVERYBODY CAN HEAR YOU.

>>  THANK YOU.

MY QUESTION INVOLVES A 

CONSIDERATION OF WHETHER OR NOT 

COST BENEFIT EVER IMPACTS 

INFORMED CONSENT.

THE QUESTION OF WHETHER THE 

THERAPIES THAT WOULD BE SO 

DERIVED ARE ACCESSIBLE, IS THAT 

A CONSIDERATION FOR SUBJECTS 

THAT MIGHT PLACE THEMSELVES AT 

RISK?

>> SO IT IS A VERY GOOD 

QUESTION.

I WOULD ARGUE THAT 

CONSIDERATIONS OF COSTS AND 

ACCESSIBILITY ACTUALLY COME IN 

UNDER DECISIONS ABOUT WHAT'S 

VALUABLE.

WHAT'S VALUABLE TO DO RESEARCH 

ABOUT?

WHAT SHOULD WE BE TESTING?

WHO IS IT VALUABLE FOR?

CERTAINLY THOSE DECISIONS HAVING

BEEN MADE, IF THEY'RE RELEVANT 

TO THE DECISION-MAKING OF THE 

PARTICIPANT, THEY SHOULD BE 

REITERATED AT THAT POINT, I 

DON'T THINK THEY'RE JUST 

LIMITED -- REFINE YOUR QUESTION,

THE CONCERN ABOUT THE COST AND 

BENEFIT AND WHAT IS GOOD FOR THE

PUBLIC HEALTH IS NOT AN ISSUE 

LIMITED TO INFORMED CONSENT, IT 

IS WAY EARLIER THAN THAT 

THINKING ABOUT WHAT IS OK AS A„i

STUDY.

HOW YOU PICK A QUESTION.

DOES THAT HELP?

>> YES. 

>> THE CAUSE OF DEATH WITH 

RESPECT TO THE JESSIE KEL
DSINGER 

DEATH EVER BEEN POSITIVELY 

IDENTIFIED?

I THOUGHT IT WAS THE CHANGE OF 

THE PROTOCOL OF THE GENE THERAPY

AGENT.

I LEARNED THAT WAS NOT TRUE.

I WONDER WHO YOU CAN SAY ABOUT 

WHY HE ACTUALLY DIED?

>> YEAH, I ACTUALLY DON'T KNOW 

WHAT THE CAUSE OF DEATH WAS.

MY UNDERSTANDING WAS IT WAS A 

REACTION TO THE ADENOVIRUS 

VECTOR THAT WAS -- IN WHICH THE 

GENE WAS IMPLANTED.

BUT I DON'T KNOW.

SOMEBODY MIGHT, BUT I DON'T.

SOR

SORRY.

ANY OTHER QUESTIONS?

HOPEFULLY THIS PROVIDE AID  -- 

PROVIDED A FRAMEWORK FOR THE 

REST OF COURSE.

HOPEFULLY YOU WILL HEAR MORE 

COMING UP.

OK.

I WILL INTRODUCE OUR NEXT 

SPEAKER.

OUR NEXT SPEAKER IS SUSAN 

LEDERER, SHE'S A HISTORIAN THAT 

HAS WRITTEN A LOT OF WONDERFUL 

BOOKS AND ARTICLES ABOUT THE 

HISTORY OF CLINICAL RESEARCH, 

CURRENTLY AT THE UNIVERSITY OF 

WISCONSIN, SHE'S GOING TO TALK 

TO YOU ABOUT SOME VERY IMPORTANT

EVENTS IN THE HISTORY OF 

RESEARCH THAT HAVE LED UP TO 

UNDERSTAND SOME OF THE ETHICS.

>> IS THAT THE FIRST SLIDE?

WELL, GOOD MORNING, IT IS A 

PLEASURE TO FOLLOW DR. GRADY.

A LITTLE INTIMIDATING, SINCE 

SHE'S SO CLEAR AND WONDERFUL IN 

HER EXPOSITION.

MY GOAL IS TO AMPLIFY THROUGH 

THE HISTORICAL CONTEXT, 

PARTICULARLY OF THE 1960s AND 

1970s, WHEN REVELATIONS OF 

SCANDALS AND TRAGEDIES INVOLVING

HUMAN SUBJECTS HAD A MATERIAL 

EFFECT.

THAT IS, IT CREATED THE 

POLITICAL WE'LL FOR CONGRESS, 

FOR THE FIRST TIME IN AMERICAN 

HISTORY, TO INTERVENE INTO 

MEDICAL RESEARCH AND CREATE 

REGULATIONS AND OVERSIGHT 

MECHANI

MECHANISMS FOR RESEARCH 

INVOLVING HUMAN SUBJECTS.

I THINK IT IS CLEAR FROM 

DR. GRADY'S EXPOSITION, SORT OF 

THE RULES THAT YOU MAKE IN 

RESPONSE TO A SCANDAL AND 

TRAGEDY ARE NOT NECESSARILY THE 

SAME RULES THAT YOU WOULD CREATE

IF YOU SET DOWN SORT OF 

INDEPENDENTLY OF THAT CONTEXT 

AND TRIED TO CREATE THE BEST 

SYSTEM OF REGULATION TO ENSURE 

GOOD RESULTS AND ADEQUATE 

PROTECTION FOR HUMAN SUBJECTS.

NOW, THE PURPOSE OF THIS SLIDE, 

WHICH MAY SEEM A LITTLE 

MYSTERIOUS IS THAT THERE HAVE 

BEEN, I WOULD SAY, YOU KNOW, 

OVER THE COURSE OF THE 20th 

CENTURY, LEGISLATION -- 

PARTICULARLY WHEN IT COMES TO 

PATIENT WELFARE AND CONSUMER 

SAFETY, IN RESPONSE TO 

REVELATIONS OF SCANDALS AND 

TRAGEDY.

I WILL GIVE YOU A COUPLE OF 

EXAMPLES.

IN THE LATE 19th CENTURY THERE 

WERE DECADES OF CONCERN ABOUT 

THE SAFETY OF THE FOOD SUPPLY 

AND OVER-THE-COUNTER DRUGS SOLD 

BY PATENT MEDICINE MAKERS.

EXPLANATIONS IN COLLIERS ABOUT 

DEATHS IN THE MARKETPLACE.

PRODUCTS LIKE THIS SOLD AS 

MOTHER'S HELPER.

COCAINE TOOTH DROPS, YES, IT 

WILL MAKE YOUR BABY QUIET.

HOWEVER, SORT OF THE LEGISLATION

TO PROTECT CONSUMERS CAME IN 

1906 IN RESPONSE TO A POLITICAL 

EXPOSE BY SINCLAIR WHO WAS 

SEEKING TO„i EXPOSE THE
CONDITIONS

IN SINCLAIR.

I AIMED FOR THE NATION'S HEART 

BUT I GOT THEIR STOMACH.

IT WAS CONCERNED ABOUT THE 

TERRIBLE CONDITION OF DYING COWS

BEING TURNED INTO SAUSAGE OR 

WORKERS FALLING INTO VATS, 

BECOMING LEAF LARD AND 

ENCOURAGED CONGRESS AND THE 

PRESIDENT TO PASS THE FIRST FOOD

AND DRUG ACTS IN AN EFFORT TO 

PROTECT CONSUMERS.

BETWEEN 1906 AND 1938 THERE WERE

CONCERNS ABOUT THE ADEQUACY OF 

THE SITUATIONS.

THERE WAS MASCARA THAT BLINDED 

WOMEN OR WEIGHT LOSS DRUGS THAT 

WERE EFFECTIVE IN REDUCING 

WEIGHT LOSS BECAUSE THEY 

ACTUALLY KILLED YOU.

THAT IS NOT WHAT GOT LEGISLATION

PASSED.

IT WAS THE TERRIBLE DEATHS OF 

SOME 107 CHILDREN IN 1937 THAT 

LED TO THE REVISION OF THE FOOD,

DRUG AND COSMETIC ACT IN 1938. 

>> SULFA WAS DISCOVERED IN THE 

1930s AND VALUABLE.

TO MAKE IT MORE PALATABLE FOR 

CHILDREN, A CHEMIST CHOSE A 

SWEET-TASTING SOLVENT, 

DIETHYLENE GLYCOL THAT IS GREAT 

IN ANTIFREEZE AND NOT 

NECESSARILY IN CHILDREN.

IT LED TO THE DEATHS OF 107 

CHILDREN AND YOUNG ADULTS AND 

THE CHEMIST LATER COMMITTED 

SUICIDE.

THE INADEQUACIES OF THE REGS LED

TO MAJOR REVISIONS, SORT OF 

INSISTING THAT DRUGS AND 

COSMETIC HIS TO BE TESTED FOR 

TOXICITY BEFORE THEY WERE 

MARKETED TO CONSUMERS BUT NEEDED

TO BE ADEQUATE DIRECTIONS ON THE

PACKAGES AND INCLUDING SOME 

DRUGS SHOULD BE MUCH MORE 

TIGHTLY REGULATED AND SOLD BY 

PRESCRIPTION ONLY.

THIS WAS CONCERN ABOUT TOXIC 

PESTICIDES ON THAT CROP, 

PARTICULARLY AROUND 

THANKSGIVING, MORE THAN THAT IN 

THE EARLY 1960s, IT WAS CONCERN 

OVER THE SIDE EFFECTS, THE 

UNUSUAL BIRTH DEFECTS ASSOCIATED

WITH THE DRUG THAT HAD BEEN 

RELEASED IN EUROPE.

IT IS SOLID MIDE.

THE CONCERN THAT AMERICANS COULD

BE GIVEN THE DRUG WITHOUT 

KNOWLEDGE AS PREMARKETING 

SURVEYS WAS DISTURBING.

THERE WERE PUBLIC HEARINGS.

THERE WERE IMPORTANT AMENDMENTS 

TO THE FOOD AND DRUG ACT IN 

ORDER TO ENSURE OR AT LEAST TO 

PROMOTE PATIENT WELFARE AND 

CONSUMER SAFETY.

THE FIRST CONGRESSIONAL 

LEGISLATION TO PRODUCT HUMAN 

SUBJECTS WAS NOT ABOUT HUMAN 

BEINGS BUT ABOUT ANIMALS.

THE ANIMAL WELFARE ACT HAS BEEN 

REVISED SINCE THEN, BUT THE 

TIPPING POINT FOR CONGRESS TO 

ENACT SUCH LEGISLATION CAME 

AFTER A VERY WELL-PUBLICIZED 

PHOTO ESSAY IN LIFE MAGAZINE 

ENTITLED CONCENTRATION CAMPS FOR

DOGS THAT DETAILED SORT OF 

EFFORTS OF PET-THEFT RINGS, 

TERRIBLE CONDITIONS OF PUPPY 

MILLS, THE HORRIBLE CONDITIONS 

IN WHICH ANIMALS WERE KEPT IN 

BEFORE BEING BROUGHT TO THE 

LABORATORY.

WHICH GETS ME TO WHY WE HAVE THE

FEDERAL REGULATIONS WE HAVE OR 

WERE ENACTED IN 1974, TO PROTECT

THE HUMAN SUBJECTS OF BIOMEDICAL

AND BEHAVIORAL RESEARCH.

IT IS IN RESPONSE TO THE 

REVELATION OF SCANDALS, 

TRAGEDIES, BUILDING ON THE 

EXPERIENCE OF THE REVELATION OF 

THE NASA CONCENTRATION CAMP 

EXPERIMENT THAT GIVES CONGRESS 

THE POLITICAL WILL AFTER SEVERAL

DECADES OF POTENTIAL LEGISLATION

THAT WOULD HAVE CREATED 

OVERSIGHT AND REGULATIONS.

CONGRESS DOES PASS THIS, THE 

NATIONAL RESEARCH ACT IN 1974.

NOW, AS DR. GRADY HAS ALREADY 

SUGGESTED AND I WANT TO AMPLIFY,

THE HISTORY OF HUMAN 

EXPERIMENTATION AND CONCERNS 

ABOUT THE PROPER OR APPROPRIATE 

USE OF HUMAN SUBJECTS IN MEDICAL

RESEARCH IS ACTUALLY MUCH OLDER.

AND I GUESS JUST TO REMIND YOU, 

IN THE CONTEXT OF CONGRESSIONAL 

REGULATION OF HUMAN 

EXPERIMENTATION, THAT BACK IN 

1900, THE UNITED STATES CONGRESS

ACTUALLY ENTERTAINED THIS 

LEGISLATION SENATE BILL 3424 WAS

PUT FORWARD.

HAD IT BEEN PASSED IT WOULD HAVE

REQUIRED INVESTIGATORS TO 

DISCLOSE IN ADVANCE THE PURPOSE 

AND PROCEDURES OF ANY THAT YOU 

KNOW THERAPEUTIC EXPERIMENT ON 

HUMAN BEINGS.

THE BILL, IF IT HAD BEEN PASSED 

WOULD HAVE EXPLICITLY BANNED 

CERTAIN GROUPS FROM BEING USED 

AS RESEARCH SUBJECTS.

THESE WERE MOSTLY INDIVIDUALS 

DEEMED UNABLE TO CONSENT, 

INCLUDING INFANTS, CHILDREN 

UNDER AGE 21 AND PREGNANT WOMEN 

WERE MENTALLY DERANGED, AT LEAST

IN THE BIOLOGY OF THE TIME.

THERE WAS CONCERN IN THE LATE 

19th CENTURY ABOUT THE USE AND 

EXPLOITATION OF THE VULNERABLE 

POPULATIONS.

THERE WERE ALSO -- I THINK IN 

WAYS IT IS QUITE REMARKABLE, 

THERE WERE REALLY CAREFUL 

EFFORTS AND SYSTEMATIC ATTENTION

TO ENSURING THAT HUMAN SUBJECTS 

WERE PROTECTED IN THE CONDUCT OF

RESEARCH AND GREAT CARE TO 

ENSURE THAT THEY WERE AWARE OF 

THE RISKS THAT THEY WERE GOING 

TO BE COMPENSATED THAT ALL 

NECESSARY PROTECTIONS WOULD BE 

MADE TO ENHANCE SORT OF A GOOD 

OUTCOME FOR EXPERIMENTS.

AND I'M REFERRING HERE TO THE 

YELLOW FEVER BOARDS, CONDUCT OF 

EXPERIMENTATION TO DETERMINE 

SORT OF THE MODE OF TRANSMISSION

OF YELLOW FEVER THAT WERE 

CONDUCTED BITE U.S. ARM -- BY 

THE U.S. ARMY IN 1900 AND 1901 

OF HAVANA CUBA.

AS ALREADY MENTIONED, ONE OF THE

THINGS THAT WALTER REED AND HIS 

COLLEAGUES INTRODUCED WAS 

WRITTEN PERMISSION FORMS.

YOU WILL SEE I DON'T CALL THEM 

CONSENT FORMS.

I THINK IT WOULD BE A MISTAKE TO

SEE THEM AS OUR MODERN INFORMED 

CONSENT FORMS.

THEY WERE WRINT PERMISSION FORMS

IN WHICH INDIVIDUALS THAT WERE 

BEING RECAN CUTED WERE TOLD 

ABOUT THE RISKS, THE REAL RISKS 

OF ATTEMPTING TO INCUR YELLOW 

FEVER, WHAT THE BENEFITS WERE.

I THINK REMARKABLY, CULTURALLY 

SENSITIVE, THESE WERE AVAILABLE 

IN ENGLISH AND SPANISH, BECAUSE 

IT WAS PRIMARILY YOUNG SPANISH 

MEN BEING RECRUITED FOR 

PARTICIPATION IN THE STUDIES.

ALTHOUGH, SORT OF FOLLOWING THE 

SPANISH LAWS OF ABOUT
DAUGHTADULTHOOD 

THEY HAD TO BE OVER AGE 25.

I WON'T GIVE YOU THE WHOLE FORM.

THIS IS A FLAVOR OF SOME OF THE 

LANGUAGE BEING USED.

THE UNDERSIGNED, THAT WAS AN 

TONNIO'S CONSENT FORM.

IT IS ENTIRELY IMPOSSIBLE FOR 

HIM TO AVOID THE INFECTION 

DURING THE STAY IN THE ISLAND, 

HE PREFERS TO TAKE THE CHANCE OF

CONTRACTING IT INTENTIONALLY IN 

THE BELIEF THAT HE WILL RECEIVE 

FROM THE SAID COMMISSION THE 

GREATEST CARE AND MOST SKILLFUL 

MEDICAL SERVICE.

AGAIN IDENTIFYING OR MAYBE 

DOWNPLAYING THE RISK OF SOMEONE 

CONTRACTING YELLOW FEVER BUT 

CERTAINLY THE RISK OF PATIENTING

UPON SUSPECTS RECEIVED YELLOW 

GOLD THEYOUS WERE PROMISED $200 

TO THEIR SURVIVING FAMILY 

MEMBERS IF THEY DIED CURING THE 

STUDY.

NONE OF THE HF RESEARCH SUBJECTS

DIED AS A RESULT OF 

PARTICIPATION.

ALTHOUGH AS MENTIONED JESSE 

LEVEER A YOUNG INVESTIGATOR DIED

AS A PART OF HIS PARTICIPATION 

IN THE YELLOW FEVER WORK.

ALTHOUGH THE CIRCUMSTANCES OF 

HIS INFECTION ARE SOMEWHAT 

AMBIGUOUS.

A MEMBER OF THE BOARD PUBLISHED 

WHAT HE SAW AS THE MORAL 

REQUIREMENTS PER PUTTING MEN TO 

RISK FOR THIS BENEFIT.

A WRITTEN CONSENT WAS FROM EACH 

ONE SO OUR MORAL RESPONSIBILITY 

WAS TO A CERTAIN EXTENT 

LESSENED.

HE GOES ON TO SAY ONLY THE 

HEALTHIEST WERE EXPERIMENTED ON.

SO YOU WOULDN'T RISK CONTRACTING

YELLOW FEVER IN SOMEONE ALREADY 

COMPROMISED BY OTHER ILLNESS.

FOR MOST OF THE 20th CENTURY 

THERE WAS GREAT SUPPORT FOR THE 

ENTERPRISE.

IN PART, ALSO A GREAT EMPHASIS 

ON SORT OF THE HEROISM AND 

SELF-SACRIFICE OF AMERICAN 

MEDICAL EXPERIMENTERS.

PEOPLE LIKE JESSE LAVEER OR 

JAMES CAROL.

WALTER REED WAS CELEBRATED FOR 

BEING A SELF-EXPERIMENTER.

ALTHOUGH HE DID NOT HIMSELF 

PARTICIPATE IN THE YELLOW FEVER 

EXPERIMENTS.

HE WAS THOUGHT OF AS A 

SELF-SACRIFICING MEDICAL 

TEACHER, ONE THAT PUT HIS OWN 

LIFE ON THE LINE TO ADVANCE 

MEDICAL KNOWLEDGE. 

>> THERE WAS A WIDESPREAD 

ASSUMPTION THAT THE PEOPLE 

PARTICIPATE NEGLIGENT HUMAN 

SUBJECT RESEARCH WERE 

VOLUNTEERS, NOT BEING EXPLOITED.

THEY WERE MEN AND WOMEN WHO WERE

WILLING TO INCUR THIS RISK FOR 

SCIENCE. 

>> THIS IS A STORY THAT APPEARS 

IN "NEW YORK TIMES," 1952, 

MARCH 25TH.

IT TELLS ABOUT THE DEATH OF A 

PERSON PARTICIPATING IN A BLOOD 

SUBSTITUTE STUDY AND DIED AS A 

RESULT OF HIS PARTICIPATION.

WHAT I THINK IS REALLY 

INTERESTING IS HE'S ASKED BY -- 

HIS FATHER IS ASKED BY REPORTERS

IF HE'S GOING TO SUE THE 

INVESTIGATORS.

AND THE FATHER SAYS, NO, THIS 

WAS A TRAGIC OUTCOME.

I DON'T WANT ANYTHING TO 

INTERFERE WITH ADVANCING MEDICAL

KNOWLEDGE ABOUT THIS IMPORTANT 

THING OR INTERVENTION THEY WERE 

SEEKING TO PROMOTE.

I SUGGEST IT IS VERY DIFFERENT 

THAN THE CONTEXT OF SORT OF 

RESPONSES TO THE DEATH OF YOUNG 

PEOPLE IN RESEARCH TODAY ONE 

EXAMPLE OF THE AMERICAN 

INVESTMENT IS THE ENORMOUS 

PARTICIPATION IN THE POLIO 

TRIALS OF THE VACCINE IN 1954 OR

1955.

ONE WE ARE UNLIKELY TO EVER SEE 

AGAIN.

THE LOGISTICS, ENROLLING 2 

OPINION CHILDREN IN THE VACCINE 

WAS A BEEN THING.

POLIO AFFLICTED, FOR THE MOST 

PART, AMERICAN CHILDREN.

IN THE 1950s, THE UNITED STATES 

EXPERIENCED THE WORST POLIO 

PEDESTRI

EPIDEMIC, SHOWING RES PIRATORS.

THERE WAS REAL ENTHUSIASM FOR 

FINDING AN ANSWER TO THE 

AMERICAN CHILDREN. 

>> JONAS WAS ABLE TO ENTHUSIAST 

PARENTALD AND CHILD SUPPORT FOR 

THE VACCINE.

THIS IS THE MISSION FORM.

IT IS COUCHED IN A PARENTAL 

REQUEST FOR PARTICIPATION OF THE

CHILD.

SO THE PARENTS ARE ANYTHING THAT

THE CHILD TAKE PART BECAUSE IT 

WILL BE A GOOD TO AMERICAN AND  

CHILDREN AND SOCIETY AT LARGE.

WHAT CHANGED?

I SUGGESTED THERE WAS AN 

ENORMOUS ENTHUSIASM FOR MEDICAL 

RESEARCH.

DESPITE OCCASIONAL CONCERNS 

ABOUT THE MISUSE OF HUMAN 

SUBJECTS, A WILLINGNESS TO LEAVE

THE MEDICAL RESEARCH TO MEDICAL 

RESEARCHERS THEMSELVES.

CONFIDENT AND TRUST IN THE 

MEDICAL RESEARCH ESTABLISHMENT.

ONE OF THE CHALLENGES TO THAT 

TRUST CAME WITHIN THE MEDICAL 

RESEARCH ESTABLISHMENT ITSELF.

I'M REFERRING TO THE WORST, THE 

PUBLICATIONS AND PUBLICITY 

CREATED BY PENRY XOELS BEACHER.

A VERY IMPORTANT FIGURE FOR 20th

THERE WAS ALSO THE CONVENER OF 

THE HARVARD BROAD DEATH COMMIT.

IT IS SOFRT FOR THE HEART 

TRANSPLANT ISSUES.

IN YOUR READING IS THE ART KEL, 

SOMETIMES CALLED BEACHERS 

BOMBSHELL.

SHORT ARTICLE.

IT WAS AN ARTICLE HE ORIGINALLY 

SOUGHT TO HAVE PUBLISHED IN 

JAMMA, BUT THEY REFUSED TO 

PUBLISH IT.

HE ORIGINAL SUBMITTED 50 

EXAMPLES BUT FOR REASONS OF 

SPACE IT WAS CUT DOWN TO 22 

EXAMPLES OF QUESTIONABLE 

RESEARCH PRACTICES.

AS DR. GRADY SAID, THIS WAS NOT 

THE FRINGES OF MEDICAL RESEARCH.

THESE ARE EXAMPLES FROM THE 

MAINSTREAM, FROM THE LEADING 

CENTERS OF BIOMEDICAL RESEARCH, 

FUNDED BITE LEADING FUNDERS OF 

RESEARCH, IT IS MEAN STREAM AND 

NOT FRENCH.

ONE OF THE FEATURES WAS NOT TO 

IDENTIFY THEM BY NAME BUT QUENT 

WORK SO I HAVES, TWO CAME FROM 

JAMMA, TWO FROM CIRCULATION.

AND FOR THE REST, I PUT THESE 

HERE, NOT -- JUST TO ILLUSTRATE 

THIS WAS MAINSTREAM RESEARCH 

PUBLICATIONS, SCIENCE, GENERAL 

OF CANCER.

AMERICAN GENERAL OF MEDICINE, 

GENERALANES THESIOLOGY AND 

AMERICAN JOURNAL OF THE MEDICAL 

SCIENTISTS.

THE QUESTION IS WHY WOULD 

SOMEONE IN THE CENTER OF THE 

ENTERPRISE, REVEAL THE 

SHORTCOMINGS AND DEFICIENCIES OF

HUMAN SHORTCOMING RESEARCH IN 

SUCH A PUBLIC FORUM?

THERE ARE DIFFERENT 

EXPLANATIONS, SOME SAY BECAUSE 

HE WAS A DEVOUT CHRISTIAN.

OTHERS SAY IT IS BECAUSE HE WAS 

AN ANESTHESIOLOGY THAT WAS USED 

TO CRITIQUING SURGEON.

THAT MADE IT NATURAL TO 

CRITICIZE.

OTHERS SUGGESTED IT WAS HIS OWN 

EXPERIENCE AS SOMEONE USING 

HUMAN SUBJECTS IN HIS OWN 

RESEARCH THAT PROMPTED A RATHER 

PROFOUND SORT OF CHANGE IN HEART

OR ATTITUDES.

DURING WORLD WAR TWO, FOR 

EXAMPLE, WE KNOW BEACHER DID A 

LOT OF WORK ON THE PLACEBO 

EFFECT.

HE CREATED WITH THE ARMY A MEANS

TO STUDY THOSE SEVERELY WOUNDED 

TO CARE FOR SOLDER THAT WERE 

TRAUMATICALLY INJURED, FATALLY 

INJURED DURING THE WAR EFFORT.

WE KNOW BEACHER WAS VERY 

FAMILIAR WITH THE CONDUCT OF 

NAZI EXPERIMENTS.

THESE ARE PHOTOGRAPHS TAKEN FROM

A CONCENTRATION CAMP.

THE HIGH-ALTITUDE STUDIES 

UNDERTAKEN WITH AN EYE TO 

UNDERSTANDING, YOU KNOW, THE 

CONDITIONS THAT COULD AFFECT 

GERMAN PILOTS.

AND ON THE OTHER SIDE, SORT OF 

THE HYPOTHERMIA STUDIES THAT 

INVOLVED SYSTEMATICALLY PUTTING 

PEOPLE IN CHILLED WATER, FROZEN 

WATERS AND STUDYING METHODS OF 

REWARMING, AGAIN, WITH AN IDEA 

OF FINDING SORT OF THE BEST 

MEANS TO CARE FOR PILOTS WHOSE 

AIRPLANES WERE DOWNED.

WE KNOW THAT BEACHER FOLLOWED 

VERY CLOSELY THE 1946 AND 1947 

TRIAL OF DOCTORS IN NUREMBERG.

THE PROSECUTION OF 23 MEDICAL 

PERSONNEL SORT OF IN THE CASE 

KNOWN AS UNITED STATES VS. CARL 

BRUNT.

HE WAS HITLER'S PERSONAL 

PHYSICIAN AND MEDICAL CHIEF.

WE KNOW THAT BEACHER WAS VERY 

INTERESTED IN THE SO-CALLED 

NUREMBERG CODE.

THE PRINCIPLES OF HUMAN 

EXPERIMENTATION THAT WERE 

DEVELOPED TO EVALUATE THE 

CONDUCT OF NAZI EXPERIMENTERS.

IN PARTICULAR WE KNOW BEACHER 

WAS CRITICAL OF THE FIRST 

PRINCIPLE AND MOST WIDELY 

QUOTED.

THAT IS THAT THE VOLUNTARY 

CONSENT OF THE HUMAN SUBJECT IS 

ABSOLUTELY ESSENTIAL.

NOW, IT SEEMS STRANGE TO SAY 

THAT BEACHER WAS CRITICAL OF 

THAT.

WHAT HE IS CRITICAL OF IS THE 

STRICT INTERPRETATION.

IT WAS BEACHER'S POINT, ONE THAT

HE WENT TO PURSUE OVER THE 

COURSE OF DECADES THAT IF YOU 

LIMITED ALL PARTICIPATION TO 

THOSE THAT WOULD VOLUNTARILY 

CONSENT, YOU WOULD ELIMINATE 

EXPERIMENTATION ON GROUPS WHOSE 

OUTCOMES WOULD BE BETTERED IF WE

HAD MORE INFORMATION IF THERE 

HAD BEEN EXPERIMENTATION ON 

THEM.

FOR EXAMPLE, A STRICT READING OF

THE NUREMBERG CODE WOULD 

ELIMINATE EXPERIMENTATION 

INVOLVING CHILDREN.

IT WOULD ELIMINATE 

EXPERIMENTATION INVOLVING 

PRISONERS THAT WERE AN IMPORTANT

GROUP FOR AMERICAN PHARMA-AND 

FOR THE DEVELOPMENT OF DRUGS IN 

THIS PERIOD.

IT WOULD ELIMINATE EXPERIMENTS 

ON THE DYING AND MENTALEY  -- 

MENTALLY ILL.

HE CAMPAIGNED BETWEEN 1947 AND 

1964 TO CREATE A MORE WORKABLE 

SET OF GUIDELINES FOR THE 

CONDUCT OF HUMAN EXPERIMENTATION

THAT WAS EMBODIED IN THE 

DECLARATION OF HELSINKI, ENACTED

IN 1964.

I KNOW YOU WILL HEAR MORE ABOUT 

CODE.

I WILL NOT SORT OF DEVELOP IT.

BUT THE EFFORT WAS TO CREATE A 

MORE WORKABLE CODE.

IN THE 1960s, BEACHER GREW VERY 

CONCERNED ABOUT ESPECIALLY YOUNG

PEOPLE ENTERING THE FIELD WHO 

WERE NOT PAYING SUFFICIENT 

ATTENTION TO THE NEEDS AND 

WELFARE OF THEIR RESEARCH 

SUBJECTS.

HE WAS CONCERNED THAT THIS WAS A

GROUP OF PEOPLE WHO WERE GOING 

TO ENDANGER THE VERY ENTERPRISE 

OF MEDICAL RESEARCH BY THEIR 

INATTENTION TO THIS PROBLEM.

AND HE WAS PARTICULARLY 

CONCERNED, AT LEAST IN THE 23 

EXAMPLES THAT HE DISCUSSED IN 

THE ART KEL THAT YOU WIICLE THAT
YOU WILL 
-- 

THAT PERHAPS YOU HAVE READ.

THAT INCLUDES MENTALLY RETARDED 

CHILDREN.

DELINQUENT CHILDREN.

SOLDIERS IN THE ARMED FORCES, 

CHARITY PATIENTS, THE TERMINALLY

ILL, ALCOHOLICS, CHILDREN, 

NEWBORNS, PATIENTS AT THE NIH 

CLINICAL CENTER.

I WAS GOING TO TALK ABOUT THIS.

NOW I HAVE TO.

I SAID THAT.

THIS WAS CRITICIZED IN THE 

BRITISH MEDICAL JOURNAL.

IT WAS STUDYING A NEW OBJECT  

ANTIBIOTIC, BUT HAD THE TEENS 

UNDERGO REPEATED LIVER BIOPSIES.

PERHAPS THE TWO MOST INFAMOUS 

EXAMPLES THAT WERE KNOWN INVOLVE

STUDIES OF THE WILLOW BROOK 

STATE SCHOOL ON STATEN ISLAND 

AND THE STUDIES OF THE ELDERLY 

AND DEMENTED PATIENTS OF THE 

JEWISH HOSPITAL IN NEW YORK.

THE WILLOW BROOK STATE SCHOOL 

STUDIES WERE UNDERTAKEN BY A 

DOCTOR AND HIS COLLEAGUING 

INTERESTED IN STUDYING THE 

NATUR

NATURAL PROGRESSION OF HEPATITIS

TRYING TO FIND A MEANS TO 

PREVENT THE DISEASE.

HOW DID THEY CONDUCT THIS?

WELL, WHEN CHILDREN WERE NEWLY 

ADMITTED TO THE INSTITUTION, AND

THEIR PARENTS WERE ASKED FOR 

CONSENT, USUALLY IN A GROUP 

PROCESS, THE CHILDREN WERE GIVEN

INTRAMUSCULAR INJECTIONS OF 

HEPATITIS OR MILK SHAKES FOR 

ORAL INGESTION OF THE HEPATITIS 

ORGANISM.

I CAN SAY MUCH MORE ABOUT THIS, 

BUT I THINK YOU HAVE AN 

OPPORTUNITY TO READ ABOUT IT.

THIS IS A STUDY ABOUT WHICH 

THERE REMAINS CONSIDERABLE 

CONTROVERSY.

THROUGHOUT HIS CAREER, HE 

CONTINUED TO DEFEND THE CONDUCT 

OF THE STUDIES AND CONTINUED TO 

HAVE DEFENDERS AMONG THE 

RESEARCH COMMUNITY.

THE ISSUES ABOUT INFORMED 

CONSENT.

WHEN YOU HAVE TO PLACE A 

SEVERELY RETARDED CHILD AND THE 

ONLY WAY TO GET THEM INTO AN 

INSTITUTION IS TO ENROLL THEM 

SEEMS COERCED, ABOUT THE NATURE 

OF STUDY DESIGN AND SO FORTH.

THE OTHER KIND OF INFAMOUS STUDY

THAT BEACHER IDENTIFIED BUT ALSO

DISCUSSED INDEPENDENTLY OF IT IN

THE POPULAR PRESS INVOLVED 

STUDIES OF THE JEWISH CHRONIC 

DISEASE HOSPITAL.

SOR OF A -- SORT OF A MAINSTREAM

STUDY FUNDED BY THE AMERICAN 

CANCER SOCIETY.

THEY INJECTED LIVE CANCER CELLS 

INTO ELDERLY PATIENTS WITHOUT 

THEIR KNOWLEDGE OR CONSENT.

THIS IS A QUOTE FROM ONE OF THE 

INVESTIGATORS WHO DID NOT WISH 

TO STIR UP ANY UNNECESSARY 

ANXIETY IN PATIENTS WHO HAD A 

PHOBIA ABOUT CANCER.

SO YOU DON'T WANT TO CREATE 

ANXIETY, BUT YOU WANT TO FIND 

THE ANSWER TO THIS.

AND SOME OF THE HOSPITAL 

ADMINISTRATORS AND MEMBERS OF 

THE BOARD OF TRUSTEES, YOU KNOW,

THOUGHT THIS HAD THE WHIFF OF 

THE CONCENTRATION CAMP.

I MEAN, HOW COULD THIS GO ON IN 

THE UNITED STATES?

BEACHER PUBLISHES HIS CRITIQUE 

IN THE JOUSRNAL OF MEDICINE BUT 

ALSO WIDELY FOLLOWED IN THE 

PRESS.

THE WILL TO CREATE LEGISLATION 

TO OVERSEE AND MANAGE THE 

RESEARCH ENTERPRISE COMES WITH 

THE REVELATION, JULY 25, 1972, 

THAT THE UNITED STATES PUBLIC 

HEALTH SERVICE CONDUCTED A STUDY

OF UNTREATED SYPHILIS IN A 

POPULATION OF 400 

AFRICAN-AMERICAN MEN IN RURAL 

ALABAMA.

EVEN WHEN EFFECTIVE 

INTERVENTION -- THERAPEUTIC 

INTERVENTIONS BECAME AVAILABLE, 

THESE MEN HAD NOT RECEIVED THEM.

THIS IS AN EDITORIAL CARTOONS 

THAT FOLLOWED THIS.

NO-TREATMENT STUDY, 40 YEARS, 

POPULATION, ONLY 

AFRICAN-AMERICAN MEN, RURAL AND 

IMPOVERISHED AREA.

YOU PROBABLY KNOW ABOUT THE 

STUDY.

THE STUDY BEGAN IN 1932 AT A 

TIME WHEN THE SURGEON GENERAL, 

THOMAS PERRIN AND OTHERS WERE 

COMMITTED TO SORT OF SOLVING THE

SYPHILIS AND VENEREAL DISEASE 

PROBLEM BY BRINGING IT OUT OF 

THE CLOSET, AS IT WERE AND 

MAKING IT A PUBLIC CAUSE.

1939, CHICAGO, A PUBLIC 

DEMONSTRATION ABOUT ENDING THE 

SCOURGE UPON THE LAND.

SURGEON GENERAL THOMAS PERRIN.

AND INITIALLY, THE TUSKEGEE 

SYPHILIS STUDY WAS GOING TO BE A

DEMONSTRATION AND TREATMENT 

PROJECT.

IT BEGAN WITH A 1929 SURVEY OF 

THE INCIDENCE OF SYPHILIS AMONG 

AFRICAN-AMERICANS IN SIX 

DIFFERENT AREAS.

THIS IS FROM PERRIN'S BOOK IN 

WHICH THERE IS CONSIDERABLE 

VARIATION WHEN IT COMES TO 

SYPHILIS, SAY IN TENNESSEE AND 

MACON COUNTY, ALABAMA WHERE THE 

PUBLIC HEALTH SERVICE OFFICIALS 

WERE ASTOUNDED TO SEE THE EXTENT

OF SYPHILITIC INFECTION THERE 

AND BELIEVE THIS WAS A PUBLIC 

HEALTH EMERGENCY OF THE HIGHEST 

KIND. 

AGAIN, INITIALLY, THEY THOUGHT 

THERE WOULD BE FUNDS TO TREAT 

INDIVIDUALS.

HOWEVER, IN 1929, THE GREAT 

DEPRESSION CAME ABOUT.

THERE WERE NO FUNDS, THE 

PHILANTHROPIC FUNDS FOR THIS 

PROJECT DRIED UP.

NO STATE FUNDS AVAILABLE.

SO A YOUNG PUBLIC HEALTH SERVICE

VENEREAL DISEASE INVESTIGATOR 

SUGGESTED THEY UNDERTAKE A 

SIX-MONTH STUDY OF UNTREATED 

SYPHILIS WITH THE IDEA THAT ONCE

MONEY BECAME AVAILABLE, THEY 

COULD GO IN AND TREAT THIS 

ALREADY-IDENTIFIED GROUP OF 

INDIVIDUALS.

AND SO IT IS HE WHO PROPOSING 

THEY FOLLOW THE GROUP AS A STUDY

IN NATURE.

THEY'RE TOO POOR TO GET 

TREATMENT, DON'T UNDERSTAND 

THEIR DISEASE AND„i CONVENIENTLY

AVAILABLE TO BE STUDIED.

IT IS VONNEDO LEER THAT RECRUITS

THEIR PARTICIPATION AND GETS 

THEM TO PARTICIPATE IN THE 

THINGS THE RESEARCHERS WANT 

DONE.

INCLUDING A LUMBAR PUNCTURE, 

PUNCTURE OF THE SPINAL COLUMN TO

GET FLUID TO TEST IT FOR 

SYPHILIS. 

>> IN VOND EAR'S CASE, HE CALLED

IT THE LAST CHANCE OF FREE 

TREATMENT OF THEIR BAD BLOOD.

THIS IS A PURELY DIAGNOSTIC 

PROCEDURE.

IT WAS, AT LEAST, ACCORDING TO 

THE MEN, AN EXTRAORDINARILY 

PAINFUL PROCEDURE TO UNDERGO.

ONE IN WHICH THEY THOUGHT THEY 

WERE GETTING TREATMENT FOR THEIR

DISEASE.

SO BETWEEN 1932 AND 1972 THEY 

CONTINUED IN INTERVALS TO 

MONITOR THE PROGRESS OF 

UNTREATED SYPHILIS IN THIS 

POPULATION.

THIS INCLUDED PERIODIC BLOOD 

DRAWS, BRINGING THE MEN IN FOR 

VARIOUS CARDIOVASCULAR DISEASES 

AND LESIONS THAT COME ABOUT FROM

THIS TYPE OF DECISION.

AND THEN THIS BECAME THE 

DELIBERATE STUDY OF UNTREATED 

INFECTION.

SOME OF THE MEN WOULD HAVE BEEN 

CALLED UP FOR MILITARY SERVICE 

FOR WORLD WAR II, IF THEY HAD 

BEEN CALLED UP AND IT WAS 

DETERMINED THEY HAD SYPHILIS 

THEY WOULD HAVE RECEIVED FREE 

TREATMENT FROM THE ARMY.

IN ORDER TO PREVENT THAT AND TO 

ALLOW THE DATA COLLECTION TO 

CONTINUE, THE PUBLIC HEALTH 

SERVICE ASKED THE MACON COUNTY 

DRAFT BOARD TO EXEMPT THESE MEN 

FROM BEING CALLED UP FOR 

MILITARY SERVICE, ARGUING THEY 

WERE SERVING IN A DIFFERENT WAR,

SORT OF THE WAR AGAINST SEXUALLY

TRANSMITTED DISEASE, A 

CONSIDERATION THAT WAS GIVEN BY 

THE MACON COUNTY DRAFT BOARD.

ONE OF THE THINGS THAT MADE THE 

TUSKEGEE SYPHILIS STUDY POSSIBLE

OVER SUCH A LONG PERIOD WAS THE 

DECISION TO EMPLOY A SUBPUSH -- 

SUPERB

SUPERBLY EXTRAORDINARY 

AFRICAN-AMERICAN NURSE THAT 

OBTAINED PERMISSION TO HAVE THE 

AUTOPSY PERFORMED ONCE THE MEN 

DIED.

SHE EXPLAINED IN AN ARTICLE THAT

IT WAS EASIER TO GET PERMISSION 

FROM THE MEN WHEN THE MEMORIAL 

FUND HAD BEGUN PROVIDING A 

BURIAL STIPEND OF $50.

AFTER THAT STIPEND BECOMES 

AVAILABLE, SHE HAD ONLY ONE 

REFUSAL AND SOME 140 REQUESTS.

$50 DID NOT GO TO THE FAMILY.

$15 OF THAT WENT TO THE 

PATHOLOGY THAT PERFORMED THE 

POSTMO

POSTMORT UM  -- PORT MORTEM AND 

35 WENT TO THE FAMILY FOR THE 

FUNERAL SERVICES. 

>> A LOT HAPPENED, INCLUDING IN 

THE AFTERMATH OF WORLD WAR II IN

THE NUREMBERG DOCTOR'S TRIAL, 

THE CONCERN OF WHETHER OR NOT 

THEY WERE TREATING THE MEN 

APPROPRIATELY IN THE STUDY.

AND I'M REFER TO THIS PEOPLE WHO

WERE RUNNING THE VENEREAL 

DISEASE RESEARCH LABORATORY IN 

THE 1950s WHO ARE RESPONSIBLE 

FOR THE ONGOING CONDUCT OF THE 

TUSKEGEE SYPHILIS STUDY.

THE MAN THAT DIRECTED THAT 

SIDNEY O. LANSKI.

HE WAS CONCERNED ABOUT THE 

NATURE OF PARTICIPATION OF MEN 

IN THE STUDY.

SO THAT FOR THE FIRST TIME IN 

1954 -- AGAIN, SO THE TUSKEGEE 

SYPHILIS STUDY WAS NOT SECRET.

OVER 13 ARTICLES ABOUT UNTREATED

SYPHILIS IN THIS POPULATION WERE

PUBLISHED IN MAINSTREAM AMERICAN

ARTICLES.

FOR THE FIRST TIME IN ONE OF THE

ARTICLES IN 1954, THE MEN IN 

ALABAMA ARE IDENTIFIED AS 

VOLUNTEERS WITH SOCIAL 

INCENTIVES.

I THINK VOLUNTEER IS A 

EUPHEMISM.

YOU CAN'T VOLUNTEER IF YOU DON'T

KNOW THE STATUS OF YOUR 

PARTICIPATION.

IT WAS ALSO OLANSKI'S IDEA TO 

IMPROVE THE ESPRIT DE CORPS , 

FOR THEM TO RECEIVE A 

CERTIFICATE SIGNED BY THE PUBLIC

HEALTH SURGEON GENERAL.

YOU CAN SEE SORT OF AN ORDER OF 

GRATEFUL PARTICIPATION FOR 

ACTIVE PARTICIPATION IN THE 

STUDY.

AND EACH OF THE MEN WHO RECEIVED

THIS ALSO RECEIVED A DOLLAR FOR 

EACH YEAR THEY HAD PARTICIPATED 

IN THE STUDY.

SO $25.

WE KNOW IN THE '60s, AN ARTICLE 

QUESTIONING WHY THEY WERE NOT 

TREATED.

AN INVESTIGATOR WAS ASTOUNDED 

THEY WERE ONLY STUDYING 

UNTREATED SYPHILIS IN A 

POPULATION SOLELY OF 

AFRICAN-AMERICAN MEN.

HE WROTE SEVERAL LETTERS, HE WAS

BROUGHT TO THE C.D.C.

AND PARTLY IN RESPONSE TO HIS 

CENTERS FOR DISEASE CONTROL 

ACTUALLY CONVENE AID BLUE-RIBBON

PANEL TO EVALUATE WHETHER OR NOT

THE TUSKEGEE SYPHILIS STUDY 

SHOULD CONTINUE.

I THINK IT IS TELLING, THE ONLY 

PHYSICIAN MEMBER OF THIS PANEL 

WHO WAS NOT PREVIOUSLY FAMILIAR 

WITH THE STUDY BEFORE 

PARTICIPATING IN THE PANEL WAS 

THE ONLY ONE WHO SAID AT THAT 

TIME THE STUDY SHOULD BE STOPPED

AND ALL THESE MEN SHOULD BE 

OFFERED TREATMENT FOR THEIR 

DISEASE.

BUT HE WAS A MINORITY OPINION 

AND THE C.D.C. DECIDED THE STUDY

SHOULD CONTINUE WHICH IT DID 

UNTIL 1972 WHEN A REPORTER PUT 

THE STORY OUT ON THE ASSOCIATED 

PRESS AND IT BEGAN APPEARING IN 

NEWSPAPERS ACROSS THE COUNTRY, 

TO THE GREAT SHOCK, DISMAY OF 

AMERICANS AND PEOPLE AROUND THE 

WORLD.

A YOUNG SENATOR TED KENNEDY 

INVITED PETER BUCKSTON TO 

PARTICIPATE IN PUBLIC HEARINGS 

ABOUT THE CONDUCT OF HUMAN 

EXPERIMENTATION.

AS WERE SOME OF THE MEN WHO HAD 

BEEN LONG-TIME PARTICIPANTS IN 

THE TUSKEGEE SYPHILIS STUDY.

THEY CAME TO WASHINGTON HOW THEY

WERE TOLD THEY HAD BAD BLOOD, 

ENLISTED IN THE STUDY WITH REALM

VERY LITTLE UNDERSTANDING ABOUT 

THE NATURE OF THEIR 

PARTICIPATION.

AGAIN, I WOULD ARGUE THAT THE 

TUSKEGEE SYPHILIS STUDY IS THE 

TIPPING POINT ABOUT THE ONGOING 

DECADE TO GET PROTECTION PASSES 

THE NATIONAL RESEARCH ACT OF 

1974.

ONE OF THE THINGS THAT THAT ACT 

DOES IS TO CREATE THE NATIONAL 

COMMISSION ABOUT WHICH YOU WILL 

HEAR MUCH MORE AND ABOUT ONE OF 

THE PRODUCTS WAS IN FACT THE 

BELMONT REPORT.

THE NATIONAL RESEARCH ACT 

FOSTERS THE NEW FEDERAL 

REGULATIONS THAT MANDATE THE 

INSTITUTION AND ADMINISTRATION 

OF INSTITUTIONAL REVIEW BOARDS 

AND WRITTEN, INFORMED CONSENT.

SO FOR THE FIRST TIME, SORT OF 

FEDERAL OVERSIGHT INTERVENTION 

IN THE MEDICAL RESEARCH 

ENTERPRISE INVOLVING HUMAN 

SUBJECTS.

NOW I WANTED TO SAY THAT FOR 

MANY PEOPLE, SORT OF THE NEWS 

ABOUT THE TUSKEGEE SYPHILIS 

STUDY, THE REVELATION IT 

OCCURRED IT WAS SHOCKING BUT 

THEN IT DISAPPEARED. 

HOWEVER IT CONTINUED TO LIVE ON 

IN SOME COMMUNITIES RATHER THAN 

OTHERS.

IT WAS PICKED UP IN AMERICAN 

POPULAR CULTURE.

THERE WERE PERSISTENT STORIES 

THAT IT WASN'T JUST FOLLOWING, 

BUT THE PUBLIC HEALTH SERVICE 

HAD ACTUALLY DELIBERATELY 

INFECTED THE MEN WITH THIS 

DISEASE IN ORDER TO STUDY IT.

THIS REMAINED SORT OF AN ONGOING

AND VIBRANT STUDY.

[INDISCERNIBLE] 

BUT IT REALLY CAME TO THE 

SURFACE IN THE CONTEXT OF THE 

DISCOVERY AMITT SORT OF THE -- 

AMID, SORT OF THE SECOND DECADE 

OF THE AIDS EPIDEMIC THAT THERE 

WAS CONSIDERABLE SKEPTICISM 

ABOUT THE RESEARCH ENTERPRISE 

ITSELF.

THIS IS AN EDITORIAL THAT 

APPEARED IN "THE NEW YORK TIMES"

IN WHICH THEY -- THE EDITORIAL 

WRITERS ARE SHOCKED TO DISCOVER 

THAT SOME AFRICAN-AMERICANS ARE 

SUSPICIOUS ABOUT A VACCINE.

THAT IN FACT THE DISEASE WAS NOT

ACCIDENTAL BUT WAS DELIBERATELY 

ENGINEERED IN THE LABORATORY.

SO SORT OF THE IDEA THAT THE 

TUSKEGEE SYPHILIS STUDY, 

KNOWLEDGE ABOUT IT, ADVERSELY 

INFLUENCED AFRICAN-AMERICAN 

PARTICIPATION AS RESEARCH 

SUBJECTS WAS GREATLY DISCUSSED, 

SORT OF IN THAT DECADE.

ONE OF THE THINGS THAT WAS 

SURPRISING -- WELL, SURPRISING 

TO ME, SORT OF IN THE CONTEXT OF

THE REVELATION IN THE 1990s THAT

IN FACT THE FEDERAL GOVERNMENT 

HAD SPONSORED AT LEAST 4,000 

EXPERIMENTS ON UNSUSPECTING AND 

UNKNOWING AMERICAN PARTICIPANTS 

INVOLVING IONIZING RADIATION, 

PRESIDENT CLINTON IN 1995 

OFFERED A FORMAL APOLOGY ON 

BEHALF OF THE AMERICAN PEOPLE TO

ALL THOSE AMERICANS AND OTHERS 

WHOSE LIVES WERE DARKENED BITE 

SHADOW OF THE ATOM.

ONE OF THE THINGS THAT THE 

ADVISORY COMMITTEE PANEL ON THE 

HUMAN RADIATION EXPERIMENTS 

DISCOVERED WAS IN FACT THERE HAD

BEEN NO FEDERAL APOLOGY TO THE 

PARTICIPANTS AND FAMILIES FOR 

THE TUSKEGEE SYPHILIS STUDY.

A TUSKEGEE SYPHILIS STUDY 

COMMITTEE WAS FOUNDED.

AFTER SEVERAL YEARS A FORMAL 

APOLOGY WAS OFFERED TO THE 

SURVIVING MEN.

THERE WERE FEW AT THIS TIME, 

THEIR SURVIVING FAMILY MEMBERS 

AT THE WHITE HOUSE.

THEY CREATED A CENTER FOR 

BIOETHICS AT THE TUSKEGEE 

UNIVERSITY.

THIS IS AN IMAGE OF SOME OF THE 

MEN, NOW ELDERLY, THAT HAD BEEN 

PARTICIPANTS IN THE TUSKEGEE 

SYPHILIS STUDY.

WHY IS IT IMPORTANT?

AS I INDICATED, I THINK IT 

REALLY REPRESENTS THE TIPPING 

POINT.

MORE THAN ANY OTHER SINGLE 

EXPERIMENT, IT MOBILIZES 

CONGRESSIONAL WILL TO CREATE 

LEGAL PROTECTIONS FOR SUBJECTS.

BUT IT IS EXTRAORDINARILY 

IMPORTANT IN IONGOING
DISCUSSIONS

ABOUT THE MORALITY OF HUMAN 

EXPERIMENTATION.

THERE IS AN ANALYSIS OF HOW THE 

TUSKEGEE IS A REFERENCE FOR 

OTHER EXPERIMENTS.

IN 1997, THE THEN ACTING EDITOR 

OF THE NEW ENGLAND JOURNAL OF 

MEDICINE MARSHA ENGEL COMPARED 

THE PLACEBO CONTROLLED TRIALS OF

TRANSMISSION OF H.I.V. BETWEEN 

MOTHERS AND CHILDREN TO THE 

TUSKEGEE STUDY WHICH IS A 

POWERFUL RHETORICAL DEVICE AND 

ONE WHICH LEADERS OF THE NIH HAD

TO RESPOND TO.

TO COMPARE IT TO THE TUSKEGEE 

STUDY WAS TO MOBILIZE PUBLIC AND

PROFESSIONAL OPINION.

ANOTHER EXAMPLE.

2001 WHEN THE MARYLAND STATE 

SUPREME COURT RULED THAT THE 

FAMILIES COULD SUE THE 

KENNEDY-KREIGER INSTITUTE AT 

JOHNS HOPKINS INSTITUTION, THE 

JUDGE COMPARED THE RESEARCH OF 

LEAD PAINT TO CHILDREN LIVING IN

HOMES TO THE NAZ'S EXPERIMENT 

AND TUSKEGEE SYPHILIS STUDY.

WHEN PRESIDENT BUSH VETOED STEM 

CELL RESEARCH IN 2006, THE 

LANGUAGE THAT HIS SPEECH WRITER 

CHOSE THAT IT CONSTITUTES A 

GRAVE VIOLATION OF HUMAN RIGHTS 

AS WE SAW IN THE TUSKEGEE 

EXPERIMENTS AND NAZI 

EXPERIMENTS.

THERE IS ONGOING DISCUSSION 

ABOUT IS THE TUSKEGEE STUDY THE 

AMERICAN HOLOCAUST.

THERE ARE PEOPLE ON BOTH SIDES 

ABOUT THE UTILITY AND VALIDITY 

OF THAT COMPARISON.

I JUST WANT TO ADD, SORT OF AS I

CONCLUDE, THAT THE SCANDALS AND 

TRAGEDIES THAT BECAME KNOWN IN 

THE 1960s AND 1970s MATERIALLY 

AFFECTED THE COURSE OF THE -- 

HOW HUMAN EXPERIMENTATION WAS 

CONDUCTED IN THE UNITED STATES.

WE KNOW THAT SORT OF SCANDALS 

AND TRAGEDIES AND NEW 

REVELATIONS HAVE CONTINUED TO 

COME TO LIGHT.

SOME OF YOU MAY HAVE FOLLOWED 

THE DISCUSSION JUST EARLIER THIS

MONTH INVOLVING THE STUDY OF 

BIOETHICAL ISSUES.

IT INCLUDES DR. GRADY ON THIS 

PANEL, THAT OFFERED A REPORT ON 

SYPHILIS EXPERIMENTS THAT WERE 

CONDUCTED BY MEMBERS OF THE 

PUBLIC HEALTH SERVICE STUDY IN 

GUATEMALA BETWEEN 1946 TO 1948, 

IN WHICH INMATES IN HOSPITALS 

AND OTHER AREAS WERE 

INTENTIONALLY INFECTED WITH 

SYPHILIS AND GONORRHEA.

UNLIKE THE TUSKEGEE STUDY WHERE 

THERE IS NO EVIDENCE OF 

DELIBERATE INFECTION, HERE, THE 

IMPOSSIBLE EXPERIMENTS AT LEAST 

FOR THE UNITED STATES WERE 

UNDERTAKEN IN GUATEMALA.

PERHAPS MOST SORT OF 

INTERESTINGLY, THE DECISION 

WAS -- THEY DID THE RESEARCH BUT

THEY DECIDED IT WAS TOO 

SENSITIVE TO PUBLISH.

SO THAT IT ONLY CAME TO LIGHT 

WHEN A HISTORIAN SUSAN REVERBY 

HAPPENED TO GO THROUGH OLD 

ARCHIVES OF JOHN CUTLER AND 

FOUND THESE SORT OF SITTING IN 

THE ARCHIVE.

AGAIN, DELIBERATELY INFECTING 

INDIVIDUALS THROUGH CISTERNAL 

PUNCTURE WITH SYPHILITIC 

ORGANISMS.

I WON'T READ THE ENTIRE QUOTE.

SKIP DOWN, SURGEON GENERAL 

THOMAS PERRIN WAS AWARE OF THE 

EXPERIMENTS AND ALSO SORT OF IN 

CHARGE OF THE LABORATORY THAT 

WAS CONDUCTING THE TUSKEGEE 

SYPHILIS STUDY WHO MADE A REMARK

TO ONE OF THE PRINCIPALS IN THE 

RESEARCH, YOU KNOW, WE COULDN'T 

DO SUCH AN EXPERIMENT IN THIS 

COUNTRY, CIRCA 1946-47.

LET ME SAY BRIEFLY, IN CONSUED

CONCLUDI

CONCLUDING, IT IS USEFUL TO 

LEARN THE PAST.

THAT WON'T SHOCK YOU.

I'M A HISTORIAN.

IT IS USEFUL TO UNDERSTAND THE 

CONTEXT IN WHICH THE REGULATIONS

THAT GOVERNOR THE WAY WE DO 

CLINICAL RESEARCH TODAY WERE 

CREATED, FACILITATED AND 

IMPLEMENTED.

AND SO THE CHALLENGE BECOMES, 

HOW DO WE LIVE WITH THAT PAST 

AND WITH THE ONGOING REVELATION 

OF SCANDALS AND TRAGEDIES DURING

THOSE TIMES.

AS WE MOVE FORWARD, AGAIN, SORT 

OF TRYING TO BALANCE THE TENSION

BETWEEN ADVANCING SORT OF 

MEDICAL KNOWLEDGE AT THE SAME 

TIME PROVIDING PROTECTION FOR 

ALL THE HUMAN SUBJECTS WHO 

PARTICIPATE IN RESEARCH TODAY.

SO THANK YOU.

[APPLAUSE]

>> I WOULD BE HAPPY TO TYKE -- 

TAKE QUESTIONS, IF THERE ARE 

ANY.

>> IT WAS ALLUDED TO THAT THE 

FACT THAT THESE ACTS CAME ABOUT 

IN RESPONSE TO THE SCANDALS AND 

TRAGEDIES WERE FORMED IN THE WAY

CREATED. 

DO YOU THINK IT SHOULD HAVE BEEN

DONE DIFFERENTLY, IF IT HAD BEEN

DONE AS A MORE PLANNED OUT 

THING, NOT IN RESPONSE TO THESE?

>> I THINK THAT IS A GOOD 

QUESTION.

I GUESS -- I WILL GO BACK TO THE

DISCUSSION THAT I THINK YOU 

HEARD DR. GRADY GIVE JUST BEFORE

I SPOKE.

YOU KNOW, IF YOU WANTED TO 

APPROACH THIS SYSTEM ATTICALLY 

AFTER REVIEWATION LARGE NUMBER 

OF STUDIES AND REVIEWING EIGHT 

PRINCIPLES OF WHAT ARE THE 

NECESSARY AND SUFFICIENT 

CONDITIONS FOR APPROPRIATE HUMAN

EXPERIMENTATION?

I THINK, YOU KNOW, THAT WOULD 

BE -- I MEAN, I THINK THAT SUCH 

ATTENTION AND ENTERPRISE SELDOM 

HAPPENS BECAUSE MORE OFTEN WE'RE

RESPONDING RATHER THAN ACTING IN

SORT OF PROACTIVELY.

BUT I THINK, YOU KNOW, IT WAS 

VERY MUCH THE ASSUMPTION FOR A 

LONG TIME, YOU KNOW, THAT 

INVESTIGATORS WERE ONLY OUT TO 

EXPLOIT THE MOST VULNERABLE.

THEY WERE ONLY OUT TO USE THE 

MOST CONVENIENT.

AND THAT, YOU KNOW, IT BECAME --

I MEAN, THAT THERE WAS ACTUALLY 

A NEED FOR A CORRECTION, AT ONE 

POINT, TO ENSURE WE WEREN'T 

PROTECTING THE VULNERABLE GROUPS

SO MUCH THAT WE WERE DOING THEM 

A SERIOUS DISSERVICE BY NOT 

INCLUDING THEM AS RESEARCH 

SUBJECTS SO WE WOULD HAVE 

INFORMATION THAT WOULD BE A 

BENEFIT TO CHILDREN OR TO THE 

DYING OR TO MEMBERS OF MINORITY 

GROUPS.

BECAUSE WE DON'T HAVE THAT 

INFORMATION.

WE HAVE TO EXTRAPOLATE FROM THE 

SINGLE WHITE MALE, SORT OF YOUNG

PERSON WHO WAS THE PRIZED 

RESEARCH ANIMAL FOR SO LONG. 

>> GOOD SEEING YOU DR. LEDERER.

MY QUESTION IS ABOUT THE MORAL 

FURY.

YOU BEING A HISTORIAN, 

CONSIDERING CROSS-CULTURAL 

DIFFERENCES THAT EXIST IN THE 

WORLD NOW, TRADITIONALLY, IT 

SEEMS LIKE THERE HAS BEEN SORT 

OF CONFLICT IN THE WAY.

IN THE ONE HAND, THERE IS -- 

CERTAIN CIRCLES PEOPLE TEND TO 

HAVE THIS UNIVERSALIST 

PERSPECTIVE.

ON THE OTHER HAND, PEOPLE TEND 

TO ALSO HAVE THE RELATIVIST 

PERSPECTIVE.

SO WHAT WOULD YOU SAY SHOULD 

BE -- WHAT SORT OF FURY SHOULD 

BE IN PLACE CONSIDERING TIMES 

AND RESEARCH GOES?

SHOULD THERE BE SOMETHING IN THE

MIDDLE, WHAT I WOULD CALL ... 

RELATIVE UNIVERSALISM, SOMETHING

LIKE THAT.

YOU KNOW, WHAT --

>> THAT IS AN INTERESTING 

QUESTION.

THERE ARE BOOKS AND ARTICLES 

THAT COULD AT LEAST FILL SEVERAL

LIBRARY SHELVES ABOUT THIS.

SO I WOULD SAY, AS A SHORT 

ANSWER TO THIS QUESTION, ON THE 

ONE HAND, THE HISTORICAL 

IMPERATIVE IS, AT LEAST TO MY 

MIND, IS TO TRY TO UNDERSTAND 

HOW PEOPLE COULD HAVE MADE THE 

CHOICES THAT THEY DID AT A 

PARTICULAR TIME.

SO THE ASSUMPTIONS AND WORLD 

VIEW OF PEOPLE CHOOSING TO 

EXPERIMENT IN 1932 IS MATERIALLY

DIFFERENT THAN IT IS IN 2011.

THAT DOESN'T EXCUSE WHAT WAS 

DONE.

I MEAN, IT MAY MAKE 

UNDERSTANDABLE.

THAT MIGHT HAVE IMPLICATIONS FOR

WHAT PENALTIES, IF ANY WE WANT 

TO ASSIGN FOR THAT TYPE OF 

CONDUCT.

YOU KNOW, THIS IS OF COURSE NOT 

UNIQUE TO THE CONDUCT OF YOU 

HUMAN EXPERIMENTATION.

THERE IS LOTS OF LITERATURE, FOR

EXAMPLE, THAT LOOKS AT THE 

HISTORY OF SLAVERY AND 

ABOLITIONISM, YOU KNOW, ON THE 

ONE HAND, YOU KNOW, PEOPLE THAT 

MANY AMERICANS ADMIRE THOMAS 

JEFFERSON WAS INDEED A 

SLAVEHOLDER.

HOW DO WE DEAL THIS THAT AS A 

HISTORICAL PROBLEM IS DIFFERENT 

THAN HOW WE DOLE WITH IT AS A 

MORAL PROBLEM.

I THINK ENSLAVING SOMEONE IS 

MORALLY INDEFENSIBLE.

IT DEPENDS ON WHAT IS THE 

PURPOSE OF THE INQUIRY, I THINK,

IS WHAT IT COMES DOWN TO, AT 

LEAST IN MY MIND. 

>> THANK YOU. 

>> YOU SHOULD HAVE SAID FIRST 

CHANCE FOR COFFEE.

[CHUCKLING] 

>> COULD YOU COMMENTS ON THE 

ETHICS OF USING RESULTS FROM THE

UNETHICAL RESEARCH THAT IS DONE?

>> OH, I'M GLAD IT WAS A SIMPLE 

QUESTION.

[LAUGHTER] 

>> WELL, YOU KNOW, I THINK 

THAT -- WELL, I THINK THERE ARE 

BASICALLY THREE ANSWERS.

ONE IS WE CAN ADOPT THE POSITION

THAT WE SHOULD NOT USE ANY 

INFORMATION OBTAINED FROM 

UNETHICAL CIRCUMSTANCES.

WHICH, FROM THE HISTORY OF 

MEDICINE WOULD MEAN WE WOULD 

HAVE TO TURN OUR BACK ON A GREAT

DEAL OF MATERIALLY BENEFICIAL 

INFORMATION.

THE OTHER, THE OTHER POSITION 

WOULD BE OF COURSE WE USE IT, IT

WILL BE A BENEFIT.

THEN THERE IS WHAT I LIKE TO 

THINK OF AS SORT OF THE MIDDLE 

POSITION, WHICH IS THAT WE USE 

IT, BUT WE USE IT WITH BEING 

MINDFUL AND CALLING ATTENTION TO

THE CIRCUMSTANCES UNDER WHICH 

SUCH KNOWLEDGE WAS GAINED.

THE ONE THING THEY THINK THAT IS

VERY INTERESTING IS THIS OFTEN 

COMES UP, PERHAPS MOST STARKLY 

IN THE CONTEXT OF USING THE DATA

FROM NAZI MEDICAL EXPERIMENTS.

I HAVE HEARD SURVIVORS OF 

CONCENTRATION CAMP EXPERIMENTS 

ON BOTH SIDES OF THE ISSUE.

ON THE ONE HAND SAYING UNDER NO 

CIRCUMSTANCES SHOULD THE 

HYPOTHERMIA DATA FOR EXAMPLE, 

WHICH SOME PEOPLE RECOGNIZE AS 

USEFUL, SHOULD IT BE USED.

OTHER CONCENTRATION CAMP 

SURVIVORS OF EXPERIMENTS SAY, 

WELL, OF COURSE YOU HAVE TO USE 

IT.

WE HAVE TO HAVE SOME GOOD COME 

OUT OF SUCH MANIFEST EVIL.

I THINK THERE ARE A RANGE OF 

OPINIONS ON THIS.

THE ONE HISTORICAL POINT I WOULD

MAKE IS THAT EVEN THOUGH IT IS 

MOST STARKLY ARGUED IN THE 

CONTEXT OF NAZI MEDICAL 

EXPERIMENTATION, THIS WAS 

ACTUALLY AN ETHICAL DILEMMA THAT

RESEARCHERS FACED ACTUALLY MUCH 

EARLIER IN THE CONTEXT OF 1891, 

FOR EXAMPLE, THEY WERE 

INTERESTED IN THE ABILITY TO 

GRAFT CANCER FROM ONE PERSON TO 

ANOTHER.

TWO GERMAN PHYSICIANS WHEN A 

WOMAN WAS UNDERGOING REMOVAL OF 

A CANCEROUS BREAST TUMOR, 

WITHOUT THE WOMAN'S KNOWLEDGE, 

TOOK A PIECE OF THE TUMOR, 

IMPLANTED IT IN HER OTHER 

HEALTHY BREAST AND WAITED FOR IT

TO GROW AND WANTED TO STUDY IT 

UNDER THE MICROSCOPE TO SEE IF 

IT WAS SIMILAR.

SO TO ANSWER AN IMPORTANT 

MEDICAL QUESTION.

WHEN THIS WAS DISCUSSED AT THE 

PARIS ACADEMY OF MEDICINE, THE 

PHYSICIANS AROSE AS A BODY AND 

SAID WE CANNOT.

THIS IS SO UNETHICAL, WE WILL 

NOT DISCUSS THIS WHATSOEVER.

IT KIND OF REVERBERATED IN 

MEDICAL CIRCLES IN ENGLAND, IN 

THE UNITED STATES, IN FRANCE, 

AND IN GERMANY ABOUT IN THE 

1890s ABOUT HOW TO DEAL WITH 

THIS PROBLEM OF WHEN SOMEONE 

COMPLETELY CROSSES THE LINE BUT 

MAY HAVE GENERATED SORT OF 

USEFUL INFORMATION AT LEAST FOR 

ANSWERING A PARTICULAR QUESTION.

I THINK IT IS AN IMPORTANT 

QUESTION.

[APPLAUSE]

>> OK.

NOW YOU CAN HAVE COFFEE OR TEA

AND COOKIES AND PLEASE COME BACK

IN 15 MINUTES FOR THE NEXT 

SESSION.„i

>> I CAN PLEASE INVITE EVERYBODY

WHO IS STILL OUTSIDE TO PLEASE 

COME INSIDE AND SIT DOWN SO WE 

CAN CAN PLEASE INVITE EVERYBODY 

WHO IS STILL OUTSIDE TO PLEASE 

COME INSIDE AND SIT DOWN SO WE 

CAN CAN PLEASE INVITE EVERYBODY 

WHO IS STILL OUTSIDE TO PLEASE 

COME INSIDE AND SIT DOWN SO WE 

A AN PLEASE INVITE EVERYBODY 

WHISTI OSI TPLSE 
ACN PLEASE INVITE EVERYBODY 
MENSE D T WNO   

WHO IS STILL OUTSIDE TO PLEASE 

COME INSIDE AND SIT DOWN SO WE 

CAN START?

THE THIRD SESSION, WE WILL LOOK 

MORE IN MIND OF DO THEY APPLY TO

OUR RESEARCH?

WE ARE PRIVILEGED TO HAVE 

SOMEONE FROM THE OFFICE OF 

RESEARCH PROTECTION, IF YOU 

DON'T KNOW WHAT THAT 

CIRCUMSTANCES YOU SHOULD 

[CHUCKLING], IVOR PRITCHARD HAS 

COME TO TALK TO US ABOUT THE 

CODE AND REGULATION.

IVOR. 

>> GOOD MORNING.

I HAVE BEEN GIVEN THE TASK OF 

TALKING ABOUT WHETHER THE CODES 

APPLY TO MY RESEARCH.

I THINK CHRISTINE SUGGESTED WHY 

YOU SHOULD KNOW SOMETHING ABOUT 

OUR OFFICE.

IF YOU VIOLATE THE CODE, WE ARE 

THE PEOPLE THAT COME AFTER YOU.

WE HAVE BEEN AT THIS FOR TWO 

HOURS ALREADY.

YOU HEARD THE INSPIRATIONAL TALK

THAT TALK ABOUT THE PRINCIPLES 

PEOPLE SHOULD FOLLOW IN THE 

RESEARCH.

INSPIRATION HELPSu

>> ALSO WORRIED ABOUT RESEARCH 

INVOLVING „iWOMEN.

YOU MAY FIND THIS KIND OF A 

NO-DUH COMMENT, BUT I WAS AT A 

CONFERENCE ABOUT CLINICAL 

RESEARCH IN JORDAN A COUPLE OF 

YEARS AGO, AND SOME OF IT WAS IN

ENGLISH.

BUT THERE WAS A PUBLIC 

DISCUSSION, PUBLIC FORUM 

DISCUSSION THAT WAS IN ARABIC.

I DON'T SPEAK ARABIC.

IN THE PUBLIC FORUM, PEOPLE GOT 

BENT OUT OF SHAPE.

PEOPLE STANDING UP, THE 

DISCUSSION GOT ANIMATED.

I TURNED TO SOMEONE AND ASKED 

WHAT ARE THEY TALKING ABOUT.

IT TURNS OUT THEY WERE TALKING 

ABOUT THE ISSUE OF WHETHER, 

UNDER-ISLAMIC LAW IF A WOMAN 

WANTS TO PARTICIPATE IN A 

RESEARCH STUDY AND HER HUSBAND 

DOESN'T WANT HER TO, WHETHER SHE

HAS A RELIGIOUS OBLIGATION TO 

DECLINE TO PARTICIPATE IN THE 

STUDY IN THE INTEREST OF NOT 

CREATING FAMILY STRIVE.

 -- STRIFE.

THIS IS A QUESTION THAT THE 

PEOPLE IN THE ROOM WERE„i VERY 

ANIMATED.

AND THERE ARE QUESTIONS ABOUT 

UNDERRESOURCED AREAS.

AND BY THE WAY, WHILE I BELIEVE 

NIH DOES DO SOME WORK THAT 

INVOLVES INCREASING THE RESEARCH

INFRASTRUCTURE IN VARIOUS 

COUNTRIES WHERE NIH FUNDS 

RESEARCH AROUND THE WORLD, THE 

FIRST THREE THINGS ARE THINGS 

THAT ARE NOT REQUIRED BY 

AMERICAN REGULATIONS AND I HAVE 

AT LEAST HAD PEOPLE SAY TO ME 

THAT NIH'S MISSION ACTUALLY 

PROHIBITS IT FROM DOING THINGS 

LIKE SPENDING MONEY ON PROVIDING

CARE OUTSIDE OF THE RESEARCH 

CONTEXT TO PEOPLE WHO 

PARTICIPATED IN RESEARCH OR IN 

COMMUNITIES WHERE RESEARCH 

ACTIVITIES HAVE BEEN CARRIED OUT

WHERE THOSE RESOURCES WOULDN'T 

BE AVAILABLE OTHERWISE.

SO IF YOU'RE AT NIH, YOU APPEAR 

TO BE IN, POTENTIALLY, THIS BIND

BETWEEN NIH'S MISSION AND WHAT 

SIAM SEEMS TO WANT TO REQUIRE OF

YOU.

WHAT ARE YOU GOING TO DO?

THE BAIL BOND REPORT IS SHORT, 

EASY -- BELMONT REPORT IS SHORT,

EASY TO READ.

A CLEAR STATEMENT, I THINK, OF 

IMPORTANT ETHICAL PRINCIPLES TO 

THINK ABOUT IN RESEARCH.

IT WAS A DOCUMENT WHICH WAS 

WRITTEN BY A COMMISSION THAT WAS

CONCERNED ABOUT WHETHER THE 

STUDY OF UNTREATED SYPHILIS AND 

THE NEWS STORIES WAS GOING TO 

LEAD TO A SERIOUS DECREASE IN 

THE SOCIAL SUPPORT FOR RESEARCH.

SO THEY WANTED TO MAKE THE CASE 

FOR THE VALUE OF CARRYING OUT 

RESEARCH.

AND YOU CAN SEE THAT IN THE 

BELMONT.

IT ALSO HAS A VERY INTERESTING 

DISCUSSION OF THE DISTINCTION 

BETWEEN RESEARCH AND PRACTICE.

AND THEN IT CONTAINS THREE 

PRINCIPLES AND TALKS ABOUT THEIR

APPLICATION.

THE FIRST PRINCIPLE IS RESPECT 

FOR PERSONS.

ITS APPLICATION HAS TO DO WITH 

BOTH INFORMED CONSENT, IF PEOPLE

ARE CAPABLE OF IT OR IF PEOPLE 

HAVE LIMITED AUTONOMY, THEN 

THEIR AUTONOMY IS PROTECTED.

SO IN THIS CIRCUMSTANCE, THE 

BELMONT REPORT LIKE SIAM, UNLIKE

NUREMBERG, CLEARLY RECOGNIZES 

THE POSSIBILITY OF DOING 

RESEARCH WITHOUT INFORMED 

CONSENT.

THE SECOND PRINCIPLE, THE NOTION

OF BENEFITENCE.

IN THE CONTEXT OF BENIVE SENSE.

THE FIRST PRINCIPLE, RESPECT FOR

PERSONS, IS A PRINCIPLE THAT IS 

DRAWN FROM A PHILOSOPHICAL 

TRADITION YOU OFTEN CALL BY US 

PHILOSOPHERS WHO WANT TO SOUND 

TECHNICAL AS MEDICAL PEOPLE EON 

TOLOGY.

THE SECOND IS INSOFAR AS THEY 

MAXIMIZE WHAT IS GOOD AND 

MINIMIZE WHAT IS BAD.

THE PRINCIPLE OF BENEIFCENCE IS 

DRAWN INTO WHAT KIND OF 

INFORMATION YOU WILL DRAW OUT.

AND THEN THE APPLICATION OF THE 

INFORMATION THAT IS FROM 

SUBJECTS.

AND YOU ALREADY HEARD TODAY WHAT

ARE PROBABLY THE TWO MOST 

PROMINENT, DIFFERENT CONCEPTIONS

OF YESTERDAY WITH RESPECT TO 

SELECTION OF SUBJECT IN 

RESEARCH.

THE OLDER VERSION OF JUSTICE IS 

THE NOTION THAT BEING THE 

POPULATION THAT IS -- ABOUT 

WHICH THE RESEARCH -- ON WHICH 

THE RESEARCH IS CONDUCTED IS A 

THREAT, RIGHT?

YOU WANT TO BE OUT OF THE GROUP 

THAT THE RESEARCH IS CONDUCTED 

ON AND JUST GET INTO THE GAME 

WHEN THE BENEFITS ARE AVAILABLE.

THE MORE MODERN, IF YOU WILL, OR

LATER INTERPRETATION OF JUSTICE,

WHICH I THINK PROBABLY THE KEY 

TURNING POINT IN THE SHIFT IN 

CONSIDERATION OF THIS PRINCIPLE 

OCCURRED WITH RESPECT TO THE 

RESEARCH ON AIDS IN THE LADY 

80s, EARLY 90s IS THE 

NEGOTIATION OF NOT BEING 

INCLUDED IN THE POPULATION BEING

STUDIED IS A RISK, AN INJUSTICE,

IT IS UNFAIR NOT TO LET MY GROUP

INTO THE RESEARCH STUDY, BECAUSE

IF YOU DON'T LET ME IN, THE 

CONCLUSIONS MIGHT NOT BENEFIT MY

GROUP.

AND WE HAVE SEEN THAT AT NIH 

WITH RESPECT TO ADDITIONAL 

POLICIES HAVING TO DO WITH THE 

INCLUSION OF WOMEN AND THE 

INCLUSION OF CHILDREN IN 

RESEARCH STUDIES AS APPROPRIATE.

AND NOW I'M GOING TO TALK ABOUT 

THE COMMON RULE.

HERE AGAIN, AS WITH HELSINKI AND

SIAM, THERE IS A LINK BETWEEN 

THE BELMONT REPORT, AND THE 

REGULATIONS FOR THE PROTECTION 

OF HUMAN SUBJECTS AND RESEARCH 

PUT INTO PLACE AS REGULATIONS, 

NOT BY ACCIDENT IN 1974 BY THE 

DEPARTMENT OF HEALTH, EDUCATION 

AND WELFARE, IN ANTICIPATION OF 

THE NATIONAL COMMISSIONS COMING 

OUT WITH RECOMMENDATIONS.

SO THE REGULATIONS WERE BEING 

WRITTEN AT THE SAME TIME AS AND 

ADJUSTED AT THE SAME TIME AS THE

NATIONAL COMMISSION WAS DOING 

ITS WORK.

IF YOU LOOK AT THE REGULATIONS, 

IT IS VERY -- IT IS PRETTY PLAIN

HOW THE REGULATIONS INCORPORATE 

THE BELMONT PRINCIPLES.

THE MECHANISMS OF THE COMMON 

RULE, MY COLLEAGUES IN THE 

EDUCATION DIVISION LIKE TO 

DESCRIBE IN TERMS OF THE ABCs OF

HUMAN SUBJECTS PROTECTIONS.

THE THREE MECHANISMS FOR 

ENSURING PROTECTIONS ARE IF YOU 

ARE GETTING MONEY FROM HHS, YOU 

HAVE TO HAVE AN AFOR -- A FOR 

ASSURANCE TO MAKE SURE YOU HAVE 

MECHANISMS IN PLACE TO ENSURE IT

WILL BE CARRIED OUT IN AN 

ETHICAL WAY AND PROTECT THE 

SUBJECTS OF RESEARCH.

THE SECOND MECHANISM IS AN 

INSTITUTIONAL REVIEW.

B IS FOR BOARD.

WHICH IS LIKE HELSINKI, TO 

REVIEW AND APPROVE THE STUDY 

BEFORE IT CAN BEGIN AND ALSO HAS

TO REVIEW AND APPROVE CHANGES IN

THE RESEARCH AND DOES CONTINUING

REVIEW FOR THE RESEARCH STUDY 

UNTIL IT IS DONE.

THE SECOND MECHANISM, C IS FOR 

CONSENT OF THE SUBJECT.

THE REGULATIONS RELY ON THOSE 

THREE MECHANISMS TO AFFECT THE 

PROTECTION OF HUMAN SUBJECTS AND

RESEARCH.

AND WE CAN SEE RESPECT FOR 

BENEFITS AND BENIVE SENSE IN THE

REGULATIO

REGULATIONS.

HERE ARE THE PRIMARY PROVISIONS 

HAVING TO DO WITH AUTONOMY AND 

INFORMED CONSENT.

NOTICE THAT DOWN AT THE BOTTOM, 

IN 116, THE REGULATIONS DO 

PERMIT WAIVER OF INFORMED 

CONSENT IN SOME CIRCUMSTANCES.

>> IN ORDER TO APPROVE A 

RESEARCH STUDY THERE ARE 

DIFFERENT THINGS TO CONSIDER.

AND THESE ARE THE ONES THAT HAVE

TO DO WITH BENEFICENCE.

ONE LAST THING ABOUT INFORMED 

CONSENT.

NOTICE WHEN YOU LOOK AT THE 

REGULATORY PROVISIONS HAVING TO 

DO WITH INFORMED CONCEPT, THE 

REGULATION STANDARD IS NOT AS 

HIGH AS THAT HELSINKI STANDARD.

THE REGULATIONS DON'T REQUIRE 

YOU TO ASSESS THE UNDERSTANDING 

OF THE SUBJECT.

THEY REQUIRE YOU TO PROVIDE THE 

INFORMATION IN LANGUAGE WHICH IS

UNDERSTANDAB

UNDERSTANDABLE, BUT THAT DOESN'T

MEAN YOU ACTUALLY UNDERSTAND IT.

I MAY BE TALKING IN 

UNDERSTANDABLE LANGUAGE, BUT 

THOSE OF YOU WHO ARE DAYDREAMING

DIDN'T UNDERSTAND WHAT I JUST 

SAID.

SO EVEN THOUGH IT WAS 

UNDERSTANDABLE, YOU DIDN'T GET 

IT.

THE THING I WOULD LIKE TO POINT 

OUT ABOUT THIS REGULATORY 

PROVISION IS THAT IT IS NOT A 

STRICT UTILITARIAN STANDARD.

UTILITARIAN SAYS YOU HAVE TO 

MAXIMIZE THE BENEFIT-COST RATIO.

YOU HAVE TO CHOOSE WHAT IS BEST.

THIS IS A LOWER STANDARD.

IT SAYS THAT THE RISKS HAVE TO 

BE REASONABLE IN ANTICIPATION TO

THE -- IN RELATION TO THE 

ANTICIPATED BENEFITS.

IT IS TRUE THAT YOU HAVE TO 

OUTWEIGH THE RISKS, BUT IT IS 

TRUE THAT THE BENEFITS COULD 

HAVE BEEN GREATER WITH THE RISKS

BEING THE SAME.

SO THERE IS SOME LEEWAY THERE, 

WHICH A STRICT UTILITARIAN 

WOULDN'T BE HAPPY WITH.

AND HERE IS THE CRITERION FOR 

APPROVAL OF THE RESEARCH STUDIES

THAT HAS TO DO WITH SELECTION OF

SUBJECTS.

AND THIS CRITERION, I THINK IS 

OPEN TO BEING INTERPRETED, 

ACCORDING TO EITHER ONE OF THE 

TWO INTERPRETATIONS OF JUSTICE 

THAT I TALKED ABOUT.

OK.

SO NOW I'VE TALKED ABOUT THE 

DETAILS OF THE REGULATIONS -- 

UH-OH.

WHAT HAVE I DONE HERE?

I DROPPED THIS THING.

AND NOW ... -- OK.

GOOD.

I HAVE TALKED ABOUT THE CODES 

AND SAID, THE TITLE OF THE TALK 

WAS DO THEY APPLY TO ME.

THE NEXT QUESTION I WANT TO ASK 

IS, WHAT DOES IT MEAN TO APPLY A

CODE?

I HAVE ALREADY SAID IF YOU TOOK 

SOMETHING ON THE FACE OF IT, IT 

SEEMS TO BE PROSCRIBED OR 

PROHIBITED.

WE HAVE TO ASK OURSELVES WHAT 

KIND OF LEEWAY IS THERE IN THE 

GUIDANCE IN WHICH CODES PROVIDE.

DOES THE CODE JUST TELL ME WHAT 

TO DO SO THAT ALL I HAVE TO DO 

IS JUST LOOK AT THE CODE AND I 

KNOW WHAT TO DO AND I FOLLOW THE

CODE AND IT IS AN AUTOMATIC 

MECHANICAL THING?

OR IS THERE SOME KIND OF 

DISCRETION INVOLVED OR WHAT?

I WOULD LIKE TO OFFER YOU ONE 

WAY OF THINKING ABOUT HOW TO 

FOLLOW THE CODE WITH A VIDEO 

CLIP I'M ABOUT TO SHOW YOU.

NOW, THESE PEOPLE ARE NOT 

ACTUALLY TALKING ABOUT THE 

COMMON RULE, BUT THEY'RE TALKING

ABOUT A DIFFERENT CODE.

BUT THIS IS A CONVERSATION WHICH

I HAVE HEARD HAPPEN WITH RESPECT

TO THE COMMON RULE AND 

INTERPRETING THAT CODE HUNDREDS 

AND HUNDREDS OF TIME.

SO LET'S SEE IF I CAN GET THIS 

TO GO.

OH.

>> ACCORDING TO THE CODE OF THE 

BRETHREN, SET DOWN BY THE 

PIRATES, YOU HAVE TO LISTEN TO 

YOUR CAPTAIN. 

>> I KNOW THE CODE. 

>> ACTUALLY YOU CAN DO THEM NO 

HARM UNTIL THE PARLAY IS 

COMPLETE. 

>> SHE WANTS TO BE TAKEN TO THE 

CAPTAIN. 

>> THEN SHE'LL GO.

WE MUST HONOR THE CODE. 

>> YOUR RETURN TO SHOW WAS NOT A

PART OF THE AGREEMENT.

SECONDLY, YOU MUST BE A PIRATE 

FOR THE  PIRATE'S CODE TO APPLY 

AND IT IS MORE OF A GUIDELINE 

THAN THE ACTUAL RULE.

WHAT IS THE WORST THAT CAN 

HAPPEN?

>> THERE IS THE CODE TO 

CONSIDER. 

>> THE CODE. 

>> HANG THE CODE AND HANG THE 

RULES.

THEY'RE MORE LIKE GUIDELINES 

ANYWAY. 

>> YOU WERE SUPPOSED TO KEEP TO 

THE CODE. 

>> WE FIGURED THEY WERE MORE 

ACTUAL GUIDELINES. 

>> SO WHAT IS THE CHALLENGE OF 

APPLYING THE CODES?

BESIDES THE ISSUE OF WHETHER 

THEY'RE GUIDELINES, WHETHER 

THEY'RE RULES, THE BELMONT 

REPORT ACTUALLY TALKS ABOUT THE 

CHALLENGES OF APPLYING CODES AND

RULES.

AND ONE OF THE THINGS THAT IT 

SAYS IS THAT THE PROBLEM WITH 

RULES IS THAT THEY DON'T 

INTERPRET THEMSELVES WITH 

RESPECT TO PARTICULARLY COMPLEX 

OR CONCRETE SITUATIONS.

AND THEY COME INTO CONFLICT.

YOU HAVE A SITUATION WHERE ONE 

RULE SAYS ONE THING AND ANOTHER 

RULE SAYS ANOTHER THING AND YOU 

CAN'T DO BOTH THINGS.

AND THAT WAS THE JUSTIFICATION 

ON THE PART OF THE AUTHORS OF 

THE BELMONT REPORT, TO IDENTIFY 

BROADER, ETHICAL PRINCIPLES.

UNFORTUNATELY, THE BELMONT 

REPORT THEN GOES ON TO SAY THAT 

IT MOVES THE SAME PROBLEM UP ONE

LEVEL WITH RESPECT TO THE 

UNDERSTANDING OF PRINCIPLES.

IT CAN BE THE CASE -- AND I'M 

SURE IT IS, THAT THE ETHICAL 

PRINCIPLES THAT WE OUGHT TO 

FOLLOW CAN ALSO COME INTO 

CONFLICT.

THIS IS TRUE FOR BELMONT, THIS 

IS ALSO TRUE FOR THE EIGHT 

PRINCIPLES THAT YOU HEARD 

CHRISTINE GRADY TALK ABOUT 

EARLIER TODAY.

I WILL GIVE YOU AN EXAMPLE OF 

THIS WHICH IS FAIRLY PEDESTRIAN,

BUT I HOPE IT MAKES A POINT.

LET'S SAY I WANT TO KNOW HOW 

MANY OF YOU ARE GOING TO CHEAT?

AND HOW FREQUENT CHEATING 

BEHAVIOR IS.

I WANT TO KNOW THIS BECAUSE I 

HAVE TO FIGURE OUT WHETHER THERE

IS A VALUE IN HAVING SOME KIND 

OF OVERSIGHT MECHANISM TO KEEP 

PEOPLE FROM CHEATING.

NOW, IF -- IN ORDER TO DO THIS 

UPON.

I OUGHT TO DO SOME RESEARCH.

IN ORDER TO CARRY OUT A RESEARCH

STUDY ABOUT CHEATING I CAN'T 

TELL YOU WHETHER I'M 

INVESTIGATING WHETHER YOU CHEAT 

OR NOT.

THERE IS AN EASY WAY TO DO 

RESEARCH.

YOU ASK SOMEBODY TO DO A TASK, 

WHICH THEY CAN'T COWITHOUT 

CHEATING.

YOU GIVE THEM THE OPPORTUNITY TO

CHEAT AND YOU SEE WHETHER THEY 

DID OR NOT.

BUT YOU CAN'T TELL THE PERSON 

THAT THAT IS WHAT THE OBJECT OF 

THE RESEARCH IS.

SO HERE WE HAVE A TRADE-OFF 

BETWEEN INFORMED CONSENT RIGHT 

AND BENEFICENCE BECAUSE WE NEED 

TO KNOW HOW FREQUENT CHEATING 

BEHAVIOR IS IN ORDER TO KNOW HOW

MUCH TIME WE NEED TO SPEND 

LOOKING OVER THE SHOULDERS OF 

INVESTIGATORS TO FIND OUT OR 

MAKE SURE THEY DON'T CHEAP IN 

SOME IMPORTANT PERSPECTIVE.

THEN I WANT TO AND THE QUESTION 

OF WHY IT MATTERS IF A CODE 

APPLIES.

SO THIS IS AN OLDER CODE.

THIS IS NOT A RESEARCH ETHICS 

CODE.

BUT IT IS A CODE THAT WE HAVE A 

LOT OF EXPERIENCE WITH.

SOME OF US BELIEVE THAT WE OUGHT

TO FOLLOW THIS CODE.

BUT IN THIS RELIGIOUS TRADITION,

WE ALSO RECOGNIZE THAT BEING 

TOLD TO FOLLOW THE CODE PROVOKES

A PARTICULAR HUMAN REACTION.

WHICH PAUL DESCRIBES IN CHAPTER 

7 OF HIS LETTER TO THE ROMANS.

 "WHAT FOLLOWS IS THE LAW 

IDENTICAL WITH SIN?

OF COURSE NOT, BUT EXCEPT 

THROUGH LAW I SHOULD NEVER HAVE 

BECOME ACQUAINTED WITH SIN.

FOR EXAMPLE, I SHOULD NEVER HAVE

KNOWN WHAT IT IS TO COVET IF THE

LAW HAD NOT SAID THOU SHALL NOT 

COVET.

THROUGH THAT COMMANDMENT SIN 

FOUND ITS OPPORTUNITY AND 

PRODUCED IN ME ALL KINDS OF 

WRONG DESIRES.

IN THE ABSENCE OF LAW, SIN IS A 

DEAD THING.

THERE WAS A TIME WHEN I WAS 

FULLY ALIVE.

BUT WHEN THE COMMANDMENT CAME, 

AND I SPRINGED TO LIFE.

IT PROVED IN MY EXPERIENCE TO 

LEAD TO DEATH BECAUSE SIN FOUND 

ITS OPPORTUNITY IN THE 

COMMANDMENT, SEDUCED ME AND 

THROUGH THE COMMANDMENT KILLED 

ME" 

SO WHEN YOU GET A CODE, WHEN 

SOMEBODY TELLS YOU, YOU HAVE TO 

FOLLOW THE REGULATIONS, IT IS A 

FUNDAMENTAL FEATURE OF THE 

CHRISTIAN EXPERIENCE THAT THERE 

IS A PART OF YOU THAT 

IMMEDIATELY WANTS TO SAY, NO , I

WON'T.

YOU WOULD HAVE BEEN WILLING IT 

CLEANUP YOUR ROOM, YOUR MOTHER 

SAID CLEANUP YOUR ROOM AND YOU 

SAY NO, I DON'T WANT TO DO THAT.

WE FOLLOW COMMANDMENTS OR CODES 

FOR VARIOUS REASONS.

IN THE LATTER PART OF THE 20th 

CENTURY A GAY NAMED LARRY 

COLBURG DEVELOPED A SIX-STAGE 

VIEW OF MORAL DEVELOPMENT IN 

WHICH HE IDENTIFIED VARIOUS 

KINDS OF REASONS PEOPLE HAVE FOR

WHY THEY DO IDENTIFY SOMETHING 

AS THE MORAL THING TO DO.

HE THOUGHT THAT PEOPLE DEVELOPED

THROUGH THE STAGES.

HE'S CRITICIZED FOR HAVING A 

SEXIST INTERPRETATION OF WHAT 

ROBERTAL REASONING STAGES SHOULD

LOOK LIKE AND ACCUSED OF BEING 

INCENTIVE TO DIFFERENT KRURL 

PERSPECTIVES OF WHAT COUNTS AS 

MORAL.

IT IS STILL, IN ANY CASE, AN 

INTERESTING WAY TO THINK ABOUT 

THE VARIOUS KINDS OF REASONS 

THAT WE OFFER FOR WHY WE DO 

SOMETHING.

ONE, THE FIRST IS BECAUSE MOM 

SAID SO.

ALL RIGHT?

I'M JUST FOLLOWING ORDERS.

THE SECOND IS A SELF-INTEREST 

ORIENTATION IN WHICH YOU FOLLOW 

THE RULES IN A CALCULATED WAY 

BECAUSE YOU RECOGNIZE THAT IT IS

IN YOUR SELF-INTEREST TO DO SO.

YOU'RE TRYING TO AVOID 

PUNISHMENT.

YOU DON'T STEAL BECAUSE YOU'RE 

AFRAID YOU WILL BREAK THE RULE 

AND GET PUNISHED.

THE 30 STAGE IS I WANT TO BE A 

GOOD BOY, THE FOURTH IS A NOTION

OF A LAW AND ORDER SOCIETY.

IT'S THE LAW, SO YOU HAVE TO 

FOLLOW THE RULES.

YOU HAVE TO FOLLOW THE LAW.

THE FIFTH IS A CONTRACT OF 

NOTION WHERE YOU REALIZE, YES, 

YOU NEED TO FOLLOW THE LAWS, BUT

THOSE LAWS WERE SOMETHING IN 

WHICH YOU PARTICIPATED AND 

CREATING THEM, THEY ARE 

CHANGEABLE, BUT YOU MADE A 

CONTRACTUAL ARRANGEMENT OR 

AGREEMENT TO FOLLOW THE VARIOUS 

RULES AND YOU OUGHT TO FOLLOW 

THEM.

THEN THE HIGHEST STAGE, WHICH HE

THOUGHT WAS REPRESENTED BY THE 

PRINCIPLE OF JUSTICE IS THE 

NOTION OF I'M DOING -- I'M 

FOLLOWING AN ETHICAL PRINCIPLE 

IN DECIDING WHAT THE RIGHT THING

TO DO CIRCUMSTANCES EVEN IF THAT

MEANS FOR EXAMPLE, CIVIL 

DISOBEDIENCE.

HOW DOES THIS PLAY OUT FOR THE 

CODE S THAT WE HAVE BEEN TALKING

ABOUT?

NOBODY ENFORCES THE NUREMBERG 

CODE.

YOU ONLY FOLLOW THE NUREMBERG 

CODE IF YOU WANT TO BE A GOOD 

BOY, FOLLOW THE RULES OR 

WHATEVER.

BUT NOBODY WILL COME AFTER YOU 

FOR VIOLATING THE NUREMBERG 

CODE.

DECLARATION OF HELSINKI, IT IS 

INTERESTING, THEY COME AFTER 

YOU -- IT IS NOT LIKE MY OFFICE 

WHERE WE COME AFTER YOU WHEN YOU

ARE ACTUALLY CARRYING OUT THE 

RESEARCH SOMETIMES.

THE WAY IN WHICH HELSINKI IS 

ENFORCED IS THROUGH PUBLICATION.

YOU HAVE TO AFFIRM WHEN YOU 

SUBMIT ARTICLES FOR PUBLICATIONS

IN MEDICAL JOURNALS THAT YOU 

FOLLOWED HELSINKI IN CARRYING 

OUT THE RESEARCH.

PRESUMABLY, IF SOMEBODY CAN SHOW

YOU DIDN'T, THE AUTHORS WON'T 

PUBLISH YOUR ARTICLE.

SO THERE IS AN INCENTIVE 

PROVIDED BY THE ENFORCEMENT 

MECHANISM OF THE VALUE OF 

PUBLICATION ATTACHED TO 

HELSINKI.

THE BELMONT REPORT IS KIND OF 

SQUIRRELLY.

WE REQUIRE IN YOUR ASSURANCE 

THAT FOR ALL RESEARCH THAT YOU 

CARRY OUT THAT YOU AFFIRM THAT 

YOU WILL FOLLOW THE BELMONT 

PRINCIPLES, BUT TO MY KNOWLEDGE,

I AM NOT AWARE OF ANY CASE IN 

WHICH OUR COMPLIANCE OFFICE HAS 

HELD SOMEONE IN VIOLATION OF 

BELMONT WHEN THEY CAN'T ALSO 

CITE A REGULATORY INFRACTION.

I MAY BE WRONG ABOUT THAT.

I HAVEN'T ASKED THIS, BUT IN THE

SEVEN YEARS I HAVE BEEN THERE I 

DON'T RECALL SOMEBODY BEING 

CONVICTED JUST ON THE BASIS OF 

BELMONT.

SIAM FOLLOWS HELSINKI, THE 

COMMON RULE, WE DO HAVE AN 

ENFORCEMENT MECHANISM.

AND MOST INSTITUTIONS ALSO HAVE 

COMPLIANCE OFFICES WHERE WHEN 

THEY IDENTIFY NONCOMPLIANCE, 

THEY TAKE ACTIONS TO ENSURE 

REGULATORY COMPLIANCE AND JUST 

REPORT IT TO US, RATHER„i THAN 

WAITING FOR SOMEBODY TO IDENTIFY

IT TO US AND HAVE US COME IN AND

SHAKE THINGS UP.

SO THE LAST THING I WANT TO SAY 

ABOUT CODES IN GENERAL HERE IS 

THE QUESTION OF DO CODES WORK.

DO PEOPLE BEHAVE DIFFERENTLY 

BECAUSE OF THE EXISTENCE OF 

CODES?

AND THERE ARE -- THERE IS 

ACTUALLY SOME RESEARCH ABOUT 

THIS.

THERE WAS A SURVEY OF PHYSICIANS

ASKING THOSE WHO HAD GIVEN SOME 

KIND OF HIPPOCRATIC OATH WHEN 

THEY GRADUATED FROM MEDICAL 

SCHOOL ABOUT WHAT KIND OF 

INFLUENCE TAKING THAT OATH HAD 

ON THEIR SUBSEQUENT BEHAVIOR.

AND ACCORDING TO THEIR REPORTS, 

ONLY ABOUT A QUARTER OF THEM 

SAID THAT THE CODE MATTERED A 

LOT.

AND IF ASKED TO IDENTIFY SOME 

OTHER CODE, ONLY ABOUT 15% OF 

THEM IDENTIFIED A CODE AS BEING 

SOMETHING WAS INFLUENTIAL ON 

THEIR BEHAVIOR.

THERE HAVE BEEN A SIGNIFICANT 

NUMBER OF STUDIES OF CHEATING IN

COLLEGE.

SHOW OF HANDS.

HOW MANY OF YOU CHEATED AT ONE 

POINT OR ANOTHER WHILE YOU WERE 

IN COLLEGE?

3/4 OF YOU ARE LYING.

[LAUGHTER] 

ABOUT 75% OF THOSE WHO ARE ASKED

TO FILL OUT SURVEYS WHEN OTHER 

PEOPLE AREN'T WATCHING ADMITTED 

TO CHEATING.

AND STUDIES HAVE BEEN DONE ABOUT

WHETHER THERE WERE CODES IN 

PLACE AT COLLEGES AND COMPARING 

THE FINELIES OF CHEATING WITH 

WHETHER OR NOT THIS WAS 

SOMETHING HAPPENING AT THE 

COLLEGE.

THE ANSWER OF WHETHER CODES 

INFLUENCE BEHAVIOR OR NOT IS 

"SORT OF."

THERE WAS LESS CHEATING ON 

AVERAGE AT THOSE INSTITUTIONS 

WHICH HAD AN HONOR CODE IN 

PLACE.

BUT THERE WERE SOME COLLEGES 

WHERE THERE WASN'T MUCH CHEATING

AND THERE WASN'T A CODE.

AND THERE WAS -- THERE WERE 

INSTITUTIONS WHERE THERE WAS A 

LOT OF CHEATING AND THERE WAS A 

CODE IN PLACE.

SO THE RELATIONSHIP IS NOT 

IMMEDIATE, DIRECT AND ABSOLUTE.

WHAT THEY FOUND OUT AS THEY 

LOOKED AT A QUALITATIVE STUDY IS

IT DEPENDS ON THE CULTURE OF THE

INSTITUTION IN WHICH THE CODE IS

EMBEDDED.

IS THERE A CULTURE AT THAT 

INSTITUTION WHERE PEOPLE TAKE 

THAT CODE SERIOUSLY, RIGHT, OR 

IS IT SEEN AS SOMETHING THAT 

PEOPLE JUST LAUGH AT THAT ONLY 

PEOPLE WHO DON'T RECOGNIZE THE 

IMPORTANCE OF GETTING AN A SO 

THEY CAN GET INTO MEDICAL SCHOOL

PAY ANY ATTENTION TO.

SO TAKE A LOOK AROUND YOU.

LOOK AT THE OTHER PEOPLE IN THIS

ROOM BECAUSE IF YOU WANT TO KNOW

THE ANSWER TO THE QUESTION OF 

WHETHER YOU'RE GONNA VIOLATE THE

CODE OR NOT, THE MOST IMPORTANT 

FACTOR IN ANSWERING THAT 

QUESTION WILL BE THE BEHAVIOR 

YOU OBSERVE IN THE OTHER PEOPLE 

AT THE INSTITUTION.

IF THE PEOPLE AROUND YOU FOLLOW 

THE CODE, YOU PROBABLY WILL, 

TOO.

IF THE PEOPLE AROUND YOU AREN'T 

FOLLOWING THE CODE, SOONER OR 

LATER, YOU'RE GOING TO DO IT 

TOO.

SO I WOULD SUGGEST TO„i YOU THAT

IT IS NOT JUST IN WORRYING ABOUT

THE RELATIONSHIP BETWEEN WHETHER

THE CODE APPLIES TO YOU, BUT IT 

IS ALSO VERY IMPORTANT TO ASK 

WHENEVER YOU GET YOURSELF INTO 

AN INSTITUTION, WHAT IS THIS 

INSTITUTION GOING TO DO TO ME 

BECAUSE THAT INSTITUTION IS 

GOING TO DECIDE WHETHER YOU 

APPLY THE CODE OR NOT.

BY THE WAY, YOU MIGHT WANT TO BE

INTERESTED IN CHANGING THE CODE 

FOR THE FIRST TIME IN 20 YEARS 

OUR OFFICE IS IN THE PROCESS OF 

TRYING TO REVISE THE 

REGULATIONS.

WE PUBLISHED A NOTICE A COUPLE 

OF MONTHS AGO ASKING FOR 

COMMENTS ABOUT HOW TO CHANGE OUR

CODE.

THESE ARE SOME OF THE MAJOR 

ELEMENTS OF THAT PROPOSAL FOR 

CHANGING THE REGULATIONS.

AND I ENCOURAGE YOU TO SEND IN 

YOUR COMMENTS ABOUT THE WAYS IN 

WHICH WE OUGHT TO ALTER THE CODE

IN ORDER TO MAKE ETHICAL CONDUCT

IN THE SEARCH BETTER.

I WENT A LITTLE OVER MY TIME.

CHRISTINE, I'M SORRY.

I HAVEN'T GIVEN THIS TALK 

BEFORE.

I DIDN'T KNOW EXACTLY HOW LONG 

IT WAS GOING TO TAKE.

I'M AT THE END, FOR THOSE OF YOU

WHO ARE AWAKE, THANK YOU FOR 

YOUR ATTENTION.

[APPLAUSE]

>> IF ANYONE WOULD LIKE TO ASK 

IVOR A QUESTION, YOU ARE WELCOME

TO STAY.

IT IS 11:30.

THE TIME IS UP.

I WANT TO REMIND YOU OF A COUPLE

OF THINGS.

IF YOU HAVEN'T DONE THE PRETEST 

EYE SHOULD HAVE SAID THIS 

EARLIER -- I SHOULD HAVE SAID 

THIS EARLIER.

YOU NEED TO DO IT AT THE 

BEGINNING OF THE COURSE.

YOU NEED TO COMPARE IF PEOPLE 

LEARNED ANYTHING IN THE 

AGGREGATE FROM THE COURSE.

THE EVALUATIONS ARE CRITICAL TO 

OUR MAKING THIS COURSE AS 

RESPONSIVE TO YOUR NEEDS AS 

POSSIBLE.

FILL THEM OUT, BE AS HONEST AS 

YOU WANT TO BE.

AND I'LL SEE YOU NEXT WEDNESDAY 

MORNING AT 8:30.

IF ANYONE WANTS TO ASK IVOR 

QUESTIONS, PLEASE. 

>> ACTUALLY, PROBABLY MORE OF A 

COMMENT DR. PRITCHARD.

I GATHER THAT WE SHOULD BE WARY 

OF ANYONE THAT IMPLIES THE CODES

ARE GUIDELINES. 

>> MY POSITION WITH RESPECT TO 

THE PIRATES' CODE IS ACTUALLY, 

IN THE CASE OF THE PIRATES' 

CODE, THEY DID RIGHT NOT TO 

LEAVE JOHNNY DEPP BEHIND, IN 

VIOLATION OF THE CODE. 

>> I HAVE ONE VERY SHORT 

QUESTION.

THE WORD "EQUITABLE" WAS USED.

IS EQUITABLE BEING USED IN THE 

CONTEXT OF RESEARCH JUSTIFIABLE 

OR IS IT USED IN THE CONTEXT OF 

EQUALITY?

BECAUSE I ALWAYS GET A LITTLE 

CONFUSED ABOUT THAT.

SO ... 

>> THE NOTION OF EQUITY OR BEING

EQUITABLE HAS TO DO WITH -- IT 

IS BASICALLY INTERPRETED IN 

TERMS OF A DISTRIBUTIVE 

PRINCIPLE IN THE NOTION OF WHO 

BEARS BURDENS, WHAT PROPORTION 

OF THE BURDENS OF RESEARCH AND 

WHO REAPS THE BENEFITS.

AND THE NOTION IS THAT THOUGH 

BOTH THE BURDENS AND THE 

BENEFITS OF RESEARCH SHOULD BE 

DISTRIBUTED EQUALLY ACROSS THE 

VARIOUS POPULATIONS WITHIN 

SOCIETY.

OF COURSE, THE TRICKY PART OF IT

COMES WHEN YOU SAY, WELL, EQUAL 

WITH RESPECT TO WHAT?

BECAUSE IF YOU LOOK AT THE 

BELMONT REPORT, FOR EXAMPLE, IT 

EVEN IDENTIFIES FIVE OR SIX 

DIFFERENT WAYS OF INTERPRETING 

EQUALITY, RIGHT?

EQUITABLE DISTRIBUTION.

DO WE JUST SAY IT IS ABSOLUTELY 

EVEN?

SO LET'S SAY, FOR EXAMPLE, IF 

THERE ARE AS MANY PEOPLE -- THIS

IS NOT GOING TO BE CORRECT.

LET'S IMAGINE A SITUATION WHERE 

THERE ARE AS MANY PEOPLE IN THE 

UNITED STATES DYING FROM LUNG 

CANCER AND FROM BREAST CANCER.

HOW SHOULD YOU DISTRIBUTE 

RESEARCH MONEY?

SHOULD YOU DISTRIBUTE IT WHEN 

YOU WANT TO DISTRIBUTE IT 

EQUALLY, RIGHT?

ONE NOTION OF EQUALITY WOULD 

SAY, PUT IT ON THE LINE, 

$100 MILLION.

50 MILLION FOR BREAST AND 50 

MILLION FOR LUNG.

ANOTHER NOTION WOULD SAY, NO, 

PUT 75 MILLION INTO BREAST 

CANCER AND 25 MILLION INTO LUNG 

CANCER.

WHY?

BECAUSE THE PEOPLE WHO GET LUNCH

CANCER DESERVE IT.

THEY SMOKE OR A LOT OF THEM 

SMOKE SO THEY HAVE ALREADY GIVEN

UP THE -- TO SOME DEGREE, THE 

BENEFITS OF HEALTH CARE BY 

DELIBERATELY RISKING THEIR 

WELL-BEING THROUGH THIS 

BEHAVIOR, WHICH THEY COULD 

AVOID.

WHEREAS WITH RESPECT TO THE 

CAUSES OF BREAST CANCER, WE 

DON'T KNOW OF ANY FACTOR WHICH 

IS SOMETHING WHICH WOMEN COULD 

AVOID AND NOT GET BREAST CANCER 

AND SO THEY DESERVE MORE OF OUR 

ATTENTION BECAUSE THEY'RE NOT 

LIVING AS GOOD -- THEY'RE LIVING

BETTER LIVES THAN THE PEOPLE WHO

GET LUNG CANCER, RIGHT?

IT IS A DIFFICULT QUESTION TO 

THINK ABOUT TERMS OF EQUALITY.

THERE IS THE NOTION OF JUST 

BECAUSE MY DISEASE IS RARE, 

RIGHT?

DOES THAT MEAN THAT YOU 

SHOULDN'T SPEND ANY MONEY ON IT?

BECAUSE I HAPPEN TO HAVE A 

DISEASE THAT NOT MANY PEOPLE 

HAVE?

WHEREAS OTHER PEOPLE WHO HAVE 

COMMON -- WHO HAVE A DISEASE 

THAT IS MORE COMMON, MORE MONEY 

SHOULD BE PUT INTO SAVING THEM?

IT IS KIND OF HARD TO SAY, IF 

YOU PUT IT IN EXTREME TERMS TO 

SAY BENEFICENCE SAYS BIGGEST 

BANG FOR THE BUCK.

IF THIS IS A DISEASE THAT ONLY 

KILLS 10 PEOPLE, FORGET IT.

 A DISEASE THAT ONLY 

KILLS 10 PEOPLE, FORGET IT.

 A DISEASE THAT ONLY 

KILLS 10 PEOPLE, FORGET IT.

 A DISEASE THAT ONLY 

KILLS 10 PEOPLE, FORGET IT.