WELCOME TO THE CLINICAL CENTER GRAND ROUNDS,
A WEEKLY SERIES OF EDUCATIONAL LECTURES FOR PHYSICIANS AND
HEALTH CARE PROFESSIONALS BROADCAST FROM THE CLINICAL
CENTER AT THE NATIONAL INSTITUTES OF HEALTH IN
BETHESDA, MD.
THE NIH CLINICAL CENTER IS THE WORLD'S LARGEST HOSPITAL TOTALLY
DEDICATED TO INVESTIGATIONAL RESEARCH AND LEADS THE GLOBAL
EFFORT IN TRAINING TODAY'S INVESTIGATORS AND DISCOVERING
TOMORROW'S CURES.
LEARN MORE BY VISITING US ONLINE AT HTTP://CLINICALCENTER.NIH.GOV
>> GOOD AFTERNOON, EVERYBODY.
WE'LL GET STARTED.
I'M DAVE FROM THE DEPARTMENT OF
BIOETHICS.
AT THE NIH CLINICAL CENTER.
AND THIS IS -- I HOPE EVERYBODY
REALIZES, ETHICS GRAND ROUNDS.
OUR DEPARTMENT HOSTS ETHICS
GRAND ROUNDS FOUR TIMES A YEAR.
THIS IS THE FOURTH FOR THIS
ACADEMIC YEAR.
WE'LL START UP AGAIN FOR ANYBODY
WHO REALLY PLANS AHEAD, THE
FIRST WEDNESDAY IN OCTOBER AND
THE FIRST WEDNESDAY IN DECEMBER.
SO A COUPLE THINGS ABOUT ETHICS
GRAND ROUNDS.
THE GOAL OF THESE SESSIONS IS TO
PRESENT WHAT WE THINK ARE
INTERESTING, IMPORTANT ISSUES TO
THE BROADER NIH COMMUNITY, SO
THIS IS JUST SUPPOSED TO BE A
GENERAL ETHICAL DISCUSSION.
THIS IS NOT A SETTING FOR
SETTING POLICY OR ANYBODY'S
SPOKESPEOPLE.
SO ANYBODY WHO TALKS TODAY,
UNLESS THEY TELL YOU OTHERWISE,
THEY'RE SPEAKING ONLY FOR
THEMSELVES, NOT FOR ANY OF THE
INSTITUTIONS TO WHICH THEY'RE
AFFILIATED.
AND ANYBODY WHO HAS QUESTIONS,
IF YOU'RE IN LIPSETT, PLEASE GO
TO ONE OF THE AISLE MICS AND ASK
THEM.
IF YOU'RE ONLINE, GO TO THE
WEBSITE.
THERE SHOULD BE A "SUBMIT
QUESTIONS," YOU CLICK ON THAT.
THOSE QUESTIONS WILL GO TO MY
COLLEAGUE WHO'S SITTING HERE,
ROBERT STEELE, WHO WILL THEN ASK
THEM IN THE MIC SO EVERYBODY
GETS TO HEAR THEM.
AND ONE IMPORTANT THING IS THERE
IS CME CREDITS AVAILABLE FOR
THIS, SO IF ANYBODY IS
INTERESTED IN CME, GET READY.
I'M ABOUT TO READ THE NUMBER AND
THE CODE.
SO FOR CME, THE CODE YOU'RE
SUPPOSED TO TEXT IS 50551.
SO AGAIN, THE CODE IS 50551.
AND YOU TEXT THAT CODE TO THE
FOLLOWING PHONE NUMBER: 844
844-980-1555.
OKAY.
ANYBODY HAS SUGGESTIONS FOR
FUTURE GRAND ROUNDS, THERE'S A
PLACE ON THE WEBSITE.
YOU CAN MAKE THOSE
RECOMMENDATIONS.
ALSO I'M ON THE GLOBAL, I WOULD
LOVE TO GET ANY RECOMMENDATIONS
PEOPLE HAVE FOR FUTURE SESSIONS.
SO TODAY IS RESPECT FOR THE
DEAD, AND ARGUABLY RESPECT FOR
THE DEAD IS ONE OF THE
FUNDAMENTAL ETHICAL PRINCIPLES
ACCORDING TO MAYBE THE MOST
FAMOUS ARTICULATION OF IT BY THE
GERMAN PHILOSOPHER EMANUEL
CARNT, IT MEANS SOMETHING LIKE
TREATING OTHERS ALWAYS AS ENDS
OF THEMSELVES AND NEVER AS MEANS
ONLY, SO TREATING PEOPLE AS ENDS
AND NEVER AS A MEANS ONLY.
PHILOSOPHERS HAVE SPENT THE LAST
COUPLE HUNDRED YEARS ARGUING
ABOUT EXACTLY WHAT THAT MEANS,
BUT IN PRACTICE, IT MEANS THINGS
LIKE TAKING OTHER VIEWS
SERIOUSLY, EVEN IF YOU DISAGREE
WITH THEM, NOT LYING TO THEM IN
THE CLINICAL SETTING, GETTING
PEOPLE'S CONSENT BEFORE YOU DO
INTERVENTIONS ON THEM.
SO ONE OF THE THINGS TO NOTICE
ABOUT ALL THOSE EXAMPLES OF
RESPECT FOR OTHERS IS THAT THEY
REQUIRE THAT THE INDIVIDUAL WHOM
YOU'RE TRYING TO RESPECT IS
ALIVE, SO YOU DON'T LIE TO THEM,
THEY'RE ALIVE, YOU GET THEIR
CONSENT, THEY'RE ALIVE, AND SO
THAT RAISES THE QUESTION OF WHAT
DOES APPROPRIATE RESPECT INVOLVE
AFTER A PERSON HAS DIED.
AND THAT'S THE ISSUE THAT WE'RE
GOING TO TALK ABOUT TODAY.
AND PARTICULARLY IF YOU LOOK AT
THIS WITHIN THE CONTEXT OF
RESEARCH, THERE'S STILL OFTEN
THIS ASSUMPTION ABOUT
INDIVIDUALS BEING ALIVE.
SO ONE OF THE GUIDING DOCUMENTS
OF RESEARCH ETHICS IS CALLED THE
BELMONT REPORT, WHICH PURPORTS
TO PUT OUT THE PRINCIPLES THAT
GUIDE THE ETHICS OF CLINICAL
RESEARCH, AND WHAT THAT DOCUMENT
SAYS IN TERMS OF RESPECT IS THAT
WHAT RESPECT INVOLVES IS
BASICALLY RESPECTING PEOPLE'S
AUTONOMY.
IT LETTING OTHER PEOPLE MAKE
DECISIONS FOR THEMSELVES ABOUT
HOW THEIR LIVES GO, AND AGAIN,
OBVIOUSLY THAT REQUIRES THAT THE
INDIVIDUAL IS ALIVE.
MORE PERTINENT TO TODAY'S
SESSION, THE U.S. FEDERAL
REGULATIONS FOR CLINICAL
RESEARCH DEFINE SUBJECTS AS
RESEARCH AS INDIVIDUALS WHO ARE
LIVING.
SO AGAIN, THAT RAISES THE
QUESTION, WHAT ABOUT RESEARCH
WITH INDIVIDUALS WHO AREN'T
LIVING?
SO HERE'S WHAT LOOK LIKE TWO
VERY OBVIOUS BUT I TAKE IT ALSO
OBVIOUSLY MISTAKEN VIEWS.
ONE IS, THEY'RE DEAD.
WHAT WE'RE WORRIED ABOUT WITH
THE ETHICS OF RESEARCH IS
HARMING PEOPLE.
YOU CAN'T HARM SOMEBODY ONCE
THEY'RE DEAD, THEREFORE, YOU CAN
DO ANY SORT OF RESEARCH YOU WANT
WITH THEM.
THERE'S ONE EXTREME VIEW.
AN ALTERNATIVE EXTREME VIEW IS,
WELL, THEY CAN'T CONSENT IF
THEY'RE DEAD.
WE KNOW THAT CONSENT IS CRITICAL
FOR ETHICAL RESEARCH.
THEREFORE, YOU SHOULDN'T BE ABLE
TO DO ANY RESEARCH ON THEM AT
ALL.
THOSE, I THINK, ARE OBVIOUS
VIEWS, BOTH OF THEM ALSO AS I
MENTIONED SEEM OBVIOUSLY WRONG,
SO WHAT WE'RE GOING TO TRY TO
FIGURE OUT TODAY IF THERE'S A
REASONABLE MIDDLE GROUND
SOMEWHERE BETWEEN THOSE TWO
EXTREMES.
SO TO GET US STARTED, KATHLEEN
FENTON IS GOING TO PRESENT A
CASE FOR US TODAY.
KATHLEEN FENTON IS A PEDIATRIC
CARDIAC SURGEON.
SHE IS THE CHIEF OF THE ADVANCED
TECHNOLOGIES AND SURGERY BRANCH
AT THE NATIONAL HEART, LUNG AND
BLOOD INSTITUTE AND SHE'S ALSO
AN AFFILIATED SCHOLAR IN OUR
DEPARTMENT, THE DEPARTMENT OF
BIOETHICS.
KATHLEEN.
>> GOOD AFTERNOON, EVERYBODY.
I'M NOT AS LOUD AS DAVE.
CAN YOU HEAR ME?
>> NOBODY IS.
>> AS HE SAID, I'M EXPRESSING MY
OWN OPINIONS AND MY OWN
THOUGHTS, AND I DON'T HAVE ANY
CONFLICTS TO DISCLOSE.
THESE ARE THE LEARNING
OBJECTIVES WHICH WERE NEEDED FOR
THE CME.
WE'RE GOING TO TALK ABOUT A
POSSIBLE RESEARCH CASE WITH
INDIVIDUALS WHO ARE DECEASED.
DESCRIBING THE NATURE OF THE
RESEARCH, AND THE ETHICAL
QUESTIONS THAT ARE RAISED.
SO I'M GOING TO RAISE THE
QUESTIONS AND DR. DICKERT IS
GOING TO ANSWER THEM.
THIS IS A FICTIONAL CASE.
I KNOW SOME OF YOU WHO ARE USED
TO ETHICS GRAND ROUNDS ARE USED
TO REAL CASES.
THIS IS A FICTIONAL CASE BUT
IT'S BASED ON SOME OF THE
RESEARCH THAT'S CURRENTLY BEING
DONE AND BEING PROPOSED, AND I'M
GUESSING THAT IT'S GOING TO BE
PROPOSED EVEN MORE GOING
FORWARD.
SO THIS IS A PATIENT WHO IS A
66-YEAR-OLD RETIRED TEACHER WHO
HAS BASICALLY BEEN IN GOOD
HEALTH EXCEPT FOR HIGH BLOOD
PRESSURE, AND SHE'S GETTING
READY FOR BED ONE NIGHT AND
SUDDENLY GETS A TERRIBLE
HEADACHE AND TELLS HER HUSBAND
THAT SHE DOESN'T FEEL WELL.
AND THEN SHE LOSES
CONSCIOUSNESS.
HER HUSBAND LOOKS AT HER AND HE
THINKS SHE'S HAVING DIFFICULTY
BREATHING AND HE DOESN'T KNOW
WHAT HAPPENED.
SO HE CALLS 911.
AND AN AMBULANCE ARRIVES AND
TAKES HER TO THE HOSPITAL.
THEN HER HUSBAND PICKS UP THE
PHONE AND CALLS HIS DAUGHTER, OR
HER DAUGHTER, WHO IS A NURSE,
AND THEY BOTH GO TO THE HOSPITAL
TOGETHER.
THEY GATHER ALONG WITH THEIR TWO
SONS IN THE WAITING ROOM OF THE
EMERGENCY DEPARTMENT, WAITING TO
FIND OUT WHAT'S GOING TO HAPPEN
TO THEIR MOM.
AND A LITTLE WHILE LATER, THE
DOCTOR COMES OUT AND SAYS THAT
GL HAS HAD A SEVERE STROKE AND
HER OUTCOME IS UNCERTAIN AND
THEY'RE GOING TO TAKE HER TO THE
ICU.
SHE'S ON A VENTILATOR OR
BREATHING MACHINE AND SHE'S NOT
CONSCIOUS.
A COUPLE OF DAYS GO BY, AND SHE
GETS WORSE, NOT BETTER.
THE ICU TEAM TELLS THE FAMILY
THAT THEY'RE CONCERNED ABOUT HER
OUTCOME AND HOW SHE'S DOING NOW,
AND THAT THEY PLAN TO DO BRAIN
DEATH TESTING TO SEE IF SHE
MIGHT ALREADY BE GONE.
A FEW HOURS LATER, THE DOCTOR
COMES BACK AND TELLS THE FAMILY
THAT SHE HAS MET BRAIN DEATH
CRITERIA.
AND WHAT HAPPENS WHEN THAT
HAPPENS IN THE ICU IS THE FAMILY
IS TOLD THAT THEY HAVE DECISIONS
TO MAKE, INCLUDING WHAT FUNERAL
HOME DO THEY WANT TO CALL, THEY
NEED TO GET THE AFFAIRS IN ORDER
OF THE DECEDENT, AND THEY NEED
TO DECIDE WHETHER OR NOT THEY'RE
INTERESTED IN ORGAN DONATION.
THE DAUGHTER IMMEDIATELY SPEAKS
UP AND TELLS THE DOCTOR THAT HER
MOTHER REALLY BELIEVED IN SAVING
LIVES, AND SHE ALWAYS WANTED TO
BE AN ORGAN DONOR.
AND SO THE ICU DOCTOR IS VERY
GREAT FULL FOR THAT AND SAYS
THAT HE WILL INFORM THE OPO AND
THEY'LL BE IN TOUCH WITH THE
FAMILY TO SEE WHAT CAN BE DONE.
IN THE MEANTIME, THEY KEEP THE
PATIENT ON THE LIFE SUPPORT OR
THE VENTILATOR AND THE
MEDICATIONS UNTIL THE PERSON
FROM THE OPO ARRIVES.
WITHIN AN HOUR, SHE ARRIVES AND
SHE EXPRESSES CONDOLENCES TO THE
FAMILY AND GRATITUDE TO THEM.
BUT SHE UNFORTUNATELY HAS
REVIEWED THE CASE AND SHE SAYS
THAT SHE'S NOT QUALIFIED TO BE
AN ORGAN DONOR.
AND THE FAMILY IS VERY
DISAPPOINTED BECAUSE THAT WAS
LIKE A CONSOLATION TO THEM,
RIGHT, THAT THEIR MOTHER MIGHT
BE ABLE TO AT LEAST SOME GOOD
COULD COME OUT OF IT.
SO THE OPO REPRESENTATIVE PAUSES
FOR A MINUTE AND THEN SHE SAYS,
THERE'S ANOTHER OPTION THAT YOU
HAVE THAT MIGHT HONOR HER WISHES
TO BE ABLE TO BENEFIT OTHERS,
EVEN THOUGH SHE CAN'T DONATE
ORGANS.
THERE ARE SOME DOCTORS ON THE
HOSPITAL'S TRANSPLANT TEAM THAT
ALSO WORK AT THE LOCAL
UNIVERSITY HOSPITAL OR LOCAL
UNIVERSITY THAT'S AFFILIATED
WITH THE HOSPITAL, AND THEY'VE
BEEN STUDYING HOW TO TRANSPLANT
PIG HEARTS INTO PATIENTS WITH
HEART FAILURE, AND THEY'VE COME
A LONG WAY, THEY'VE DONE A
NUMBER OF EXPERIMENTS IN
NON-HUMAN PRIMATES, IN BABOONS,
BUT THE NEXT STEP IN THE
RESEARCH IS TO TRY TO SEE HOW
THE HUMAN IMMUNE SYSTEM WILL
RESPOND.
AND WHETHER OR NOT THE
MODIFICATIONS THEY'VE MADE TO
THE HEART AND TO THE IMMUNE
THERAPY FOR THE RECIPIENTS THAT
SEEMS TO BE WORKING IN THE
BABOONS WOULD WORK IN HUMANS OR
NOT.
THE ONLY WAY TO REALLY TEST THAT
IS ON HUMANS, BUT IT'S NOT IDEAL
TO TEST IT ON SOMEONE WHO WOULD
DIE IF THE PIG HEART STOPS
BEATING.
SO THE RESEARCHERS ARE PROPOSING
IMPLANTING THE PIG HEART INTO
SOMEONE WHO'S ALREADY BEEN
DETERMINED TO BE DEAD.
AND THIS RESEARCH INVOLVES
KEEPING A RECENTLY DECEASED
PERSON LIKE GL ON A VENTILATOR,
WHICH SUPPLIES OXYGEN TO THE
BODY AND BREATHES FOR HER, AND
IN A FEW DAYS, A SURGEON WOULD
COME AND MAKE AN INCISION INTO
THE CHEST AND TAKE HER HEART OUT
AND PUT IN A HEART FROM A PIG.
AND THEN HE WOULD CLOSE UP THE
INCISION AND SHE WOULD COME BACK
TO THE INTENSIVE CARE UNIT,
WHERE SHE WOULD BE MANAGED LIKE
ANY OTHER PATIENT WHO HAD HAD A
HEART TRANSPLANT.
SHE WOULD BE MONITORED TO SEE
HOW HER BODY REACTS TO THE
PRESENCE OF THE PIG HEART.
SHE WOULD BE ON THE VENTILATOR,
AND SHE WOULD BE KEPT ON
MEDICATIONS AND POTENTIALLY ON
OTHER MACHINES TO SUPPORT HER
ORGAN FUNCTION WHILE THEY WOULD
BE DOING TESTS AND PROCEDURES
AND SHE WOULD HAVE MORE TESTS
AND PROCEDURES THAN A NORMAL ICU
PATIENT OR A NORMAL TRANSPLANT
RECIPIENT BECAUSE THEY'RE DOING
RESEARCH.
SO THEY WOULD BE DOING, FOR
EXAMPLE, A I LOT LOT OF BIOPSIEF
THE TRANSPLANTED PIG HEART AND
MONITORING HER FOR INFECTION.
AND THEN AT THE END OF THE
RESEARCH, THE SURGEON WOULD
REMOVE THE PIG HEART AND TEST
IT, AND WOULD PERFORM AN AUTOPSY
AND WOULD THEN RELEASE THE BODY
TO THE FUNERAL HOME JUST LIKE
NORMAL.
AND THE FAMILY WOULD BE ABLE TO
HAVE A FUNERAL AT THAT POINT.
SO HERE ARE MY QUESTIONS.
AS DAVE MENTIONED, WHAT DOES
RESPECT INVOLVE WHEN IT
CONCERNING SOMEONE WHO'S DEAD?
IS IT ETHICAL AT ALL TO CONDUCT
RESEARCH ON THE DECEASED?
IS IT APPROPRIATE TO DO SO IF
THEY HAVEN'T CONSENTED TO IT?
SHOULD THEY BE ABLE TO BE KEPT
ON VENTILATORS AFTER DEATH TO DO
RESEARCH?
AND IF SO, FOR HOW LONG?
IS THE ICU THE BEST PLACE TO DO
THIS RESEARCH OR SHOULD IT BE
DONE SOMEWHERE ELSE, OUTSIDE OF
THE CLINICAL SETTING?
WHO WOULD BE TAKING CARE OF THIS
RECIPIENT?
THIS IS THE -- YOU KNOW, THE
NURSE DAUGHTER OF THIS PATIENT
OBVIOUSLY STARTS THINKING ABOUT
THIS, IS A REGULAR ICU NURSE
GOING TO TAKE CARE OF SOMEONE
WHO'S BEEN DETERMINED TO BE
DECEASED?
CAN A NURSE DECIDE SHE DOESN'T
WANT TO DO THAT, EVEN IF IT'S
HER SHIFT?
HOW WOULD THIS AFFECT THE CARE
OF OTHER PATIENTS?
WOULD THEY BE -- NURSES BE BUSY
CAREFULLY MONITORING A RESEARCH
SUBJECT AND NOT MAYBE FREE TO
TAKE CARE OF PATIENTS WHO HAVE A
CHANCE TO RECOVER?
THEN WHAT ABOUT THE FAMILY?
WOULD BE FAMILY BE ABLE TO KNOW
WHAT WAS HAPPENING WITH THE
RESEARCH AND WOULD THEY BE ABLE
TO VISIT THEIR FAMILY MEMBER?
>> OKAY.
SO BEFORE WE TRY TO ANSWER SOME
OF THOSE QUESTIONS, I JUST WANT
TO STOP FOR A MINUTE AND SEE IF
ANYBODY HAS ANY FACTUAL DETAIL
QUESTION ON THIS CASE OR THIS
TYPE OF CASE.
SO NOT QUESTION, DISCUSSION OF
ETHICS YET BUT JUST ABOUT THE
RESEARCH, ABOUT THE MEDICINE,
ABOUT THE CLINICAL SETTING IN
WHICH THIS RESEARCH IS GOING TO
TAKE PLACE?
IF YOU HAVE A QUESTION, COULD
YOU PLEASE GO TO THE MIC?
AND ROBERT WILL LET US KNOW IF
ANYBODY ONLINE HAS ONE.
HOLLY?
>> HOW LONG -- SO YOU ASKED OR
PROPOSED THE QUESTION OF HER
BEING IN THE ICU FOR AN EXTENDED
PERIOD.
DO YOU HAVE A GUESS OF HOW
MANY -- LIKE I'M THINKING ABOUT
THE NURSE AND ALL THAT'S GOING
ON, HOW LONG THE RESEARCH
PROTOCOL MIGHT LAST?
>> THIS IS AN OPEN QUESTION
ACTUALLY, BUT I CAN TELL YOU
THAT WHAT PEOPLE ARE DOING AND
WHAT PEOPLE ARE PROPOSING IS
GENERALLY IN THE RANGE OF ONE TO
TWO MONTHS.
>> DAVID?
>> HI.
ARE WE GOING TO TAKE IT FOR THE
PURPOSE OF THIS DISCUSSION GIVEN
THAT SCIENTIFICALLY, THIS WOULD
BE HELPFUL INFORMATION GIVEN
THAT PEOPLE WHO ARE BRAIN DEAD,
EVEN IF THEY'RE LEFT ON
VENTILATORS, THEY'RE STILL --
THEY HAVE BODY ORGAN SYSTEMS
THAT START TO SHUT DOWN
REGARDLESS OF WHETHER THEY'RE
KEPT ON -- YOU KNOW, COMPARED TO
A PERSON WHO HAS JUST HEART
FAILURE WHO'S NOT BRAIN DEAD,
ARE WE GOING TO SIDESTEP THAT
OR --
>> THIS QUESTION HAS ALSO BEEN
RAISED, AND PART OF THE PROPOSAL
IN RESEARCH IS TO ACTUALLY LOOK
AT HOW THE IMMUNE SYSTEM OF A
BRAIN DEAD PERSON WORKS AND
COMPARE THE IMMUNE -- OUTSIDE OF
THE UNIOGRAPHER TRANSPLANT
SETTING SEE WHAT KIND OF IMMUNE
RESPONSE OF A BRAIN DEAD PERSON
SO THAT'S A WHOLE OTHER AREA
THAT NEEDS RESEARCH, OR
QUESTION.
THANK YOU.
>> DEFINITELY TO SAY FOR ALL OF
THIS, A BACKGROUND ASSUMPTION
THAT AT LEAST IN OUR DEPARTMENT,
WE ALWAYS MAKE, IS THAT RESEARCH
IS ETHICAL ONLY IF IT'S
SCIENTIFICALLY SOCIALLY
VALUABLE.
IF IT'S NOT, THEN YOU DON'T EVEN
HAVE TO GET INTO THESE QUESTIONS
ABOUT WHAT HAPPENS IF A PERSON
IS DEAD.
DON'T DO THE RESEARCH, AND SO I
THINK FOR THE MOST PART, WE CAN
ASSUME THE STUDY WE'RE TALKING
ABOUT, SOMEBODY WHO KNOWS WHAT
THEY'RE TALKING ABOUT HAS DEEMED
THE RESEARCH TO BE
SCIENTIFICALLY OR SOCIALLY
VALUABLE.
ANYTHING ONLINE, ROBERT, BEFORE
WE MOVE ON?
>> THERE'S ONE QUESTION BUT IT'S
NOT -- THERE'S ONE QUESTION BUT
IT'S NOT A FACTUAL CLARIFICATION
QUESTION SO I THINK MAYBE IT
WOULD BE BETTER TO SAVE.
>> ALL RIGHT.
BEFORE WE MOVE ON, I'M GOING TO
REPEAT, WE'RE NOT ABLE TO
PROJECT THE CME NUMBER SO I'M
GOING TO READ THEM AGAIN.
SORRY ABOUT THAT.
SO FOR PEOPLE WHO WANT TO GET
CME CREDIT, ONCE AGAIN, THE CODE
THAT YOU WANT TO TEXT IS 50551.
AND THE TELEPHONE NUMBER YOU
WANT TO TEXT THAT TO IS THE
FOLLOWING: 844-980-1555.
OKAY.
SO TO HELP US THINK THROUGH THE
ETHICAL QUESTIONS, THE
INTRODUCTION FOR THIS STARTS
FEBRUARY 6TH, 2008.
I TOLD THE DISCUSSANT IT WAS
THAT LONG AGO RECENTLY.
HE MIGHT BE A LITTLE TRAUMATIZED
AS A RESULT OF THAT.
SO GO EASY ON HIM.
EARLY ON.
BUT THAT SESSION WAS THE SAME
DISCUSSANT, SO NEAL NOW HAS THE
HONOR OF BEING ONE OF FIVE
PEOPLE WHO'VE BEEN AT ETHICS
GRAND ROUNDS MORE THAN ONCE.
AT THAT TIME, THE MODERATOR AND
INTRODUCER WAS THE
EXTRAORDINARILY ACCOMPLISHED AND
MUCH MISSED PEOPLE MIGHT KNOW
PAUL PLOTZ, WHO WAS HERE FOR A
LONG TIME.
AND HE DID THE MODERATING AND
INTRODUCTIONS FOR US.
I SENT HIM NEAL'S CV THE NIGHT
BEFORE, JUST AS BACKGROUND, NEAL
HAD BEEN A POSTBAC FELLOW WITH
US FOR TWO YEARS.
WE KNEW HIM, WE KNEW HE WAS, AS
YOU WILL SEE, WONDERFUL, BUT HE
WAS JUST OUT OF MEDICAL SCHOOL.
PAUL GOT THE CV AND PAUL CAME
AND PAUL WAS STANDING HERE AND
HE STARTS INTRODUCING HIM AND HE
HOLDS UP NEAL'S CV AND HE SAYS,
ONE OF THE THINGS I DO WITH
CVs IS I WEIGH THEM.
AND I CAN TELL YOU, THIS
PERSON'S C V IS EXTRAORDINARILY
LIGHT.
[LAUGHTER]
THEN HE WENT ON TO SAY THAT IN
ADDITION, THIS INDIVIDUAL THAT
I'M ABOUT TO INTRODUCE IS JUST
TWO YEARS OUT OF MEDICAL SCHOOL.
I BELIEVE THEY NOW CALL THAT A
PGY2, BUT I NEVER HEARD OF THAT
BEFORE.
FEUNLLFINALLY, THIS INDIVIDUAL A
HOUSE OFFICER.
HE'S DOING THIS -- THIS PERSON
IS A HEALTH OFFICER.
THEN HE STOPS, LOOKS UP AND HE
SAYS, FOR PEOPLE WHO DON'T KNOW
THESE THINGS, THAT'S A VERY LOW
FORM OF LIFE.
[LAUGHTER]
SOMETIMES PAUL WOULD SAY
ACTUALLY WHAT HE FELT.
I COULD SAY SINCE THEN, THAT WAS
2008, SINCE THEN, NEAL HAS GONE
ON TO LOTS OF WONDERFUL THINGS.
HE IS A CARDIOLOGIST NOW.
HE'S AN ATTENDING IN THE ICU.
HE IS THE THOMAS R. WILLIAMS
ENDOWED PROFESSOR OF MEDICINE,
AND HE IS ALSO A SENIOR FELLOW
IN ETHICS AT EMORY UNIVERSITY,
AND MORE IMPORTANTLY, NEAL HAS A
PREVIOUS FELLOW IN OUR
DEPARTMENT SO WE TAKE CREDIT FOR
ALL OF THE GOOD STUFF THAT YOU
ARE ABOUT TO HEAR.
NEAL IS NOW A NATIONALLY
RECOGNIZED EXPERT IN THE ETHICS
OF CLINICAL RESEARCH,
PARTICULARLY IN EMERGENCY
SETTINGS, IN SETTINGS WHERE YOU
DON'T GET INFORMED CONSENT
BECAUSE OF EMERGENCY AND FOR
RESEARCH WITH PEOPLE AT THE END
OF LIFE.
SO WELCOME, NEAL.
HE'S GOING TO HELP US THINK
THROUGH KATHLEEN'S QUESTIONS.
[APPLAUSE]
>> YOU ASKED ME IF I REMEMBERED
THAT INTRODUCTION AND I DIDN'T,
BUT NOW I DO WELL.
I WA WOULD JUST ADD A LITTLE BIT
MORE HISTORY.
SO FIRST YOU CAN IMAGINE MY HAIR
WAS A DIFFERENT COLOR BACK THEN.
DAVE, I THINK, MENTIONED THAT
MAYBE HIS WAS TOO.
THE OTHER IS THAT THIS IS -- I
WAS THINKING BACK ABOUT WHEN I
FIRST WENT INTO THIS ROOM, AND I
WAS THE FIRST POSTBAC FELLOW
THAT YOU GUYS HAD IN 1997.
SO THIS WAS A LONG TIME AGO THAT
I FIRST CAME IN TO LIPSETT
AUDITORIUM.
I THINK -- I TOLD DAVE I
DISCOVERED I NEEDED GLASSES IN
THIS ROOM WHEN I WOULD ATTEND
SOME TALKS AND I COULDN'T READ
THE SLIDES OR WHATEVER THEY WERE
BACK THEN.
SO THIS ROOM HAS HISTORICAL
SIGNIFICANCE FOR ME, THIS PLACE
HAS A LOT OF SIGNIFICANCE TO ME,
AND I FEEL LIKE, IN TRUTH, MY
COUPLE YEARS AT NIH RIGHT AFTER
I GRADUATED COLLEGE AND TRULY
HAD NO IDEA WHAT I WAS COMING TO
DO WAS EASILY THE MOST FORMATIVE
TWO YEARS OF MY ENTIRE CAREER.
SO IT REALLY SPECIAL FOR ME
WHENEVER I GET A CHANCE TO COME
BACK HERE AND I APPRECIATE YOU
GUYS INVITING ME.
I MIGHT TRADE -- IF I COULD BE
"SATURDAY NIGHT LIVE" HOST MORE
THAN THREE OR FOUR TIMES, THAT
WOULD BE AWESOME, BUT NIH ETHICS
GRAND ROUNDS MAY BE A NICE
ALTERNATIVE TO THAT FOR ME.
SO I APPRECIATE THE INVITATION.
SO THANKS TO KATHLEEN FOR
INTRODUCING THIS CASE.
THIS IS AN ISSUE THAT I STARTED
THINKING ABOUT A BIT, ACTUALLY
QUITE SOME TIME AGO, PROBABLY
AROUND 2006, 2008.
HOLLY REMEMBERS THAT WE HAD SOME
DISCUSSIONS WHILE I WAS A PH.D.
STUDENT AT HOPKINS ABOUT THESE
SORTS OF ISSUES BECAUSE I WAS
REALLY INTERESTED IN WHAT IT
MEANS TO RESPECT PEOPLE IN THE
CONTEXT OF DOING RESEARCH.
SO IT'S ONE THAT I'VE SORT OF
MAINTAINED AN INTEREST IN AND I
STILL THINK IS FASCINATING, AND
AS KATHLEEN MENTIONED, REALLY
GROWING IN IMPORTANCE.
SO I HAVE NO RELEVANT INTEREST
RELATED TO THIS PARTICULAR TALK.
AND IN TERMS OF OBJECTIVES, WHAT
I THOUGHT I'D DO WAS GIVE A
LITTLE BIT OF HISTORICAL CONTEXT
THAT I THINK IS HELPFUL THAT
THIS IS NOT ENTIRELY NEW.
MAKE WHAT I THINK IS REALLY A
RELATIVELY STRAIGHTFORWARD CASE
FOR WHY RESEARCH ON NEWLY AND
NEARLY DEAD SUBJECTS IS
IMPORTANT AND FUNDAMENTALLY
ETHICAL.
I WILL SORT OF DIVIDE THE KINDS
OF CONCERNS THAT ARISE INTO AT
LEAST THE THINGS ABOUT TREATMENT
OF THE SUBJECT AND THEN SOME OF
THE OTHER IMPORTANT
CONSIDERATIONS THAT AREN'T
REALLY ABOUT THE SUBJECT AND
MAYBE NOT ABOUT THE SUBJECT'S
FAMILY.
AND THEN HIGHLIGHT SOME AREAS
THAT I THINK ARE REALLY
IMPORTANT IN TERMS OF PRACTICAL.
IN MANY WAYS, I THINK THIS IS A
PROBLEM ABOUT DETAILS, AND HOW
WE DEAL WITH PARTICULARS RATHER
THAN SUPER BIG PICTURE ISSUES,
ALTHOUGH WE'LL SEE IF OTHERS MAY
HAVE MORE FUNDAMENTAL QUESTIONS
THAT WE CAN TALK ABOUT.
SO I THINK IT'S IMPORTANT TO
RECOGNIZE THAT AT MANY IN THE
ROOM KNOW, OBVIOUSLY LEARNING
FROM DEAD PEOPLE IS NOT A NEW
THING.
SO FOR ANYBODY WHO'S BEEN
THROUGH MEDICAL TRAINING, THE
BASIC EXPERIENCE OF DOING
DISSECTIONS AND USING CADAVERS
IN ANATOMY LAB IS KIND OF A
FOUNDATIONAL PART OF MEDICAL
TRAINING.
SOME OF THAT MIGHT BE CHANGING,
BUT CERTAINLY NOT AN UNFAMILIAR
CONCEPT.
THIS BOOK IS ONE OF THE BEST
BOOKS I READ, STILL STICKS WITH
ME A LOT CALLED "STIFF: THE
CURIOUS LIVES OF HUMAN
CADAVERS," TALKS ABOUT ALL THE
DIFFERENT WAYS THAT WE USE HUMAN
BODIES TO LEARN, INCLUDING
THINGS LIKE CRASH TESTS, OTHER
KINDS OF THINGS THAT REALLY IN
SOME WAYS CHALLENGE NOTIONS OF
WHAT WE TYPICALLY THINK OF AS
BEING RESPECTFUL TREATMENT.
THIS IS ANOTHER ONE ABOUT A BODY
FARM IN TENNESSEE THAT DESCRIBES
SOME REALLY INTERESTING WAYS
THAT PEOPLE'S BODIES ARE USED TO
UNDERSTAND FORENSICS OF THINGS
LIKE BODIES BEING LOCKED IN
TRUNKS OR BURIED IN DIFFERENT
KINDS OF PLACES AND WATCHING
DIFFERENT KINDS OF
DECOMPOSITION, NOT EXACTLY WHAT
WE THINK OF WHEN WE THINK OF
RESPECTFUL OR REVERENT TREATMENT
OF THE BODY.
BUT IN BOTH OF THESE BOOKS, THEY
OUTLINE IMPORTANT WAYS THAT DEAD
BODIES HAVE CONTRIBUTED TO OUR
UNDERSTANDING OF MANY IMPORTANT
ISSUES.
SO THIS IS PROBABLY FOR ANYONE
WHO KNOWS THIS LITERATURE, TO ME
AT LEAST, THIS IS SORT OF LIKE
THE FOUNDATIONAL PIECE FROM 1974
THAT WILLARD GALEN WROTE CALLED
HARVESTING THE DEAD.
AND IT'S A REALLY VIVIDLY
WRITTEN PIECE ABOUT THIS CONCEPT
OF NEOMORTS IS THE TERM HE USES.
I'M JUST GOING TO READ A FEW OF
THESE SENTENCES BECAUSE I THINK
IT REALLY VIVIDLY DESCRIBES WHAT
WE'RE THINKING ABOUT TODAY.
THESE CADAVERS WOULD HAVE THE
LEGAL STATUS OF THE DEAD WITH
NONE OF THE QUALITIES ONE NOW
ASSOCIATES WITH DEATH.
THEY WOULD BE WARM, RESPIRATING,
PULSATING, EVACUATING AND
EXCRETING BODIES REQUIRING
NURSING, DIETARY AND GENERAL
GROOMING ATTENTION AND CAN
PROBABLY BE MAINTAINED SO FOR A
PERIOD OF YEARS.
IF WE CHOOSE TO, WE COULD WITH
THE TECHNOLOGY ALREADY AT HAND
LEGALLY AVAIL OURSELVES OF THESE
NEW CADAVERS TO SERVE SCIENCE
AND MANKIND IN DRAMATICALLY
USEFUL WAYS.
THE AUTOPSY THAT MOST
RESPECTABLE OF MEDICAL
TRADITIONS THAT LAST GIFT OF THE
DYING PERSON TO LIVING FUTURE
COULD BE EXTENDED IN PRINCIPLE
BEYOND OUR RECOGNITION TO SAVE
LIVES, RELIEVE SUFFERING -- WE
COULD DEVELOP HOSPITALS, AN
INAPPROPRIATE WORD BECAUSE IT
SUGGESTS THE PRESENCE LIVING
HUMAN BEINGS, BANKS OR FARMS OF
CADAVERS WHICH REQUIRE FEEDING
AND MAINTENANCE IN ORDER TO BE
HARVESTED.
TALKS ABOUT THESE -- CALLS THESE
BIOEMPORIUMS, ELABORATES WAYS
THEY CAN BE USED FOR RESEARCH OF
VARIOUS TYPES.
WAYS THEY CAN HELP IN TRAINING
OR PRACTICING PROCEDURES IN WAYS
THEY COULD PRODUCE BLOOD OR
OTHER KINDS OF BODY PRODUCTS
THAT COULD BE HELPFUL, IT GIVES
THE EXAMPLE OF POTENTIALLY
ANTITOXINS OR OTHER KINDS OF
THINGS.
SO IT'S NOT HARD TO IMAGINE LOTS
OF WAYS THAT THIS COULD -- THAT
BODIES COULD CONTRIBUTE.
I THINK THIS PIECE IS IN SOME
WAYS A NICE WAY OF CAPTURING
BOTH THE KIND OF FEAR OF THIS
WORLD AS WELL AS ITS POTENTIAL
AND TAKES IT SERIOUSLY.
SO I WANT TO GIVE ONE EXAMPLE AT
LEAST FROM THE FIELD OF
CARDIOLOGY, WHICH IS MY CLINICAL
LIFE WHERE THIS HAS REALLY BEEN
IMPORTANT.
I THINK IT'S IMPORTANT KIND OF
GROUNDING IN THIS.
THIS IS THE CASE OF THE
GLYCOPROTEIN 2B3A INHIBITORS.
THIS IS IS TREATMENT FOR ACUTE
MYOCARD YAL INFARCTION.
MYOCARD YAL INFARCTION, IT WAS
DEVELOPED IN THE 1980s.
AT THAT TIME THEY WERE PROMISING
ANIMAL DATA BUT REAL QUESTIONS
ABOUT THE ACCURACY OF ANIMAL
MODELS FOR 2B/3A INHIBITORS.
IMPORTANTLY JUST TO DESCRIBE
WHAT THIS DOES, SO THAT PICTURE
OVER TO THE RIGHT, THAT'S A
HEART ATTACK.
THAT'S A BIG CLOT IN THE
CORONARY ARTERY AND THAT'S WHAT
CAUSES M.I.
2 ABOUT/3A INHIBITORS BASICA
BASICALLY -- PLATELET
AGGREGATION SO A WAY TO HELP
ADDRESS THAT IN THE CONTEXT OF
ACUTE MIs.
SO NOT SURPRISINGLY, IF YOU'RE
DOING THIS, YOU HAVE A
SIGNIFICANT RISK OF BLEEDING,
AND THEY NEEDED TO DO
PHARMACOKINETIC, PHARMACODYNAMIC
AND TOXICITY DATA IN HUMANS.
IT WAS CONSIDERED TO BE TOO
RISKY AN INTERVENTION TO TEST IN
HEALTHY SUBJECTS, WHICH IS WHAT
WE TYPICALLY MIGHT DO, AND TOO
RISKY FOR INDIVIDUALS COMING
INTO THE HOSPITAL WITH A HEART
ATTACK BECAUSE THOSE ARE PEOPLE
WHO IF IT WENT WRONG COULD DIE.
SO THE FIRST IN HUMAN STUDIES
WERE DONE IN BRAIN DEAD PERSONS.
WHO WERE INELIGIBLE FOR ORGAN
DONATION, JUST LIKE OUR CASE
THAT KATHLEEN DESCRIBES OF GL.
IMPORTANTLY, THESE DRUGS WERE
DEMONSTRATED TO BE SUFFICIENTLY
SAFE AND THEN WENT THROUGH THE
TYPICAL COURSE OF PHASE 1, 2,
3 TRIALS AND HAD BECOME A
MAINSTAY OF TREATMENT OF ACUTE
MI.
WE TONIG DON'T USE THESE PARTICR
DRUGS AS MUCH ANYMORE BECAUSE
THERE IS A REPLACEMENT BUT NO
QUESTION THE CORNERSTONE FOR
YEARS.
SO IT'S A WONDERFUL SUCCESS
STORY, I THINK, OF THOUGHTFUL
APPLICATION OF THIS KIND OF WAY
OF STUDYING PEOPLE.
OTHER EXAMPLES THAT WE WON'T GO
THROUGH IN DETAIL BUT PHASED
DELIVERY SYSTEMS FOR CANCER IN
PATIENT WITH AGGRESSIVE DISEASE,
EXTERNAL OXYGENATION IN CRITICAL
LUNG INJ INJURY AND OBVIOUSLY
XENOTRATRANSPLANTATION IN THE PS
RECENTLY AND IN THE CASE WE'RE
TALKING ABOUT TODAY.
SO I WANT TO MAKE A BASIC CASE
FOR WHY I THINK THIS IS ETHICAL.
SO FIRST, I THINK IT'S CLEAR
THAT AS DESCRIBED IN THE CASE OF
GL, THIS CAN BE VERY RESPECTFUL
OF THE DESIRES OF INDIVIDUALS
AND THEIR FAMILY MEMBERS TO
CONTRIBUTE IN THEIR DEATH.
IT OFFERS OPPORTUNITIES VERY
CONCRETELY TO PEOPLE INELIGIBLE
FOR ORGAN DOU DONATION, WHICH IE
OF THE OTHER MAIN ALTERNATIVES
WE HAVE FOR MAKING A
CONTRIBUTION IN THIS STATE.
I THINK IT'S ALSO IMPORTANT WITH
THE CAVEAT THAT RELATED TO THE
QUESTION THAT WAS ASKED, THIS
CAN BE SCIENTIFICALLY
ADVANTAGEOUS.
IT HAS IMPORTANT ADVANTAGES OVER
SOME ANIMAL MODELS AS DESCRIBED
IN THE CASE OF 2B/3As AND CAN
CREATE SITUATIONS THAT CAN'T BE
CREATED IN LIVE PERSONS.
AGAIN, THIS IS WITH THE CAVEAT
ABOUT POTENTIAL LIMITATIONS
ABOUT BRAIN DEATH IN CERTAIN
KINDS OF STATES.
IT AVOIDS RISK TO TRADITIONAL
SUBJECTS, SO BOTH HEALTHY
SUBJECTS AND PATIENTS, THAT'S
WHY I THINK THE 2B/3A CASE IS A
GOOD EXAMPLE, IT SHOWS WHY BOTH
TYPICAL POPULATIONS FOR STUDYING
THIS ARE INAPPROPRIATE.
AND I THINK IT'S ENTIRELY
CONSISTENT FROM AN ETHICAL
PERSPECTIVE WITH OTHER WAYS THAT
WE USE BODIES.
I MENTIONED EARLY ON SOME OF THE
WAYS THAT WE USE BODIES THAT
DON'T INVOLVE PERPETUATING ORGAN
FUNCTION BUT IN THE CASE OF
ORGAN DONATION, WE CERTAINLY
PERPETUATE ORGAN FUNCTION IN
ORDER TO ALLOW FOR APPROPRIATE
PROCUREMENT OF ORGANS.
SO I DON'T THINK IT
NECESSARILY -- THERE'S NO
DISCONNECT WITH OTHER WAYS WE
USE BODIES.
SO WHERE ARE THE CONCERNS?
I THINK ONE GROUP OF CONCERNS
HAS TO DO WITH THE SUBJECT
ITSELF, AND I'LL JUST SAY AS A
CAVEAT, I'LL CHOOSE TO USE THE
WORD "SUBJECT."
ONE OF THE INTERESTING THINGS
ABOUT THIS WORLD IS NOBODY'S
REALLY FOUND THE VOCABULARY YET
TO TALK ABOUT ENTITIES IN
VARIOUS STATES OF EXISTENCE.
WE'LL USE THE WORD SUBJECTS
BECAUSE THEY'RE PEOPLE WHO ARE
BEING STUDIED.
I WANT TO SAY PEOPLE BEING
STUDIED -- THEY ARE BODIES BEING
STUDIED AND WE'RE GOING TO CALL
THEM SUBJECTS FOR THE PURPOSE OF
DISCUSSION.
SO ONE SET OF WORRIES HAS TO DO
WITH DISRESPECTFUL TREATMENT,
RIGHT?
AND IN GENERAL, WHEN WE THINK
ABOUT DISRESPECTFUL TREATMENT,
WE TALK ABOUT THE KINDS OF
TREATMENTS THAT PEOPLE WOULDN'T
HAVE WANTED.
OR THAT VIOLATE NORMS OF HOW WE
TREAT PERSONS OR BODIES.
I'VE THOUGHT A LOT ABOUT ISSUES
OF RESPECT AND I THINK IN
GENERAL, THIS IS OFTEN WHEN WE
ACT IN WAYS THAT DON'T
DEMONSTRATE THAT WE
APPROPRIATELY VALUE AS DAVE
MENTIONED PERSONS AS ENDS AND
NOT JUST AS MERE MEANS.
A SECOND SET OF CONCERNS ABOUT
SUBJECTS HAS TO DO WITH HARMS.
IN THE CASE OF PARTICULARLY THE
NEARLY DEAD POPULATION, YOU HAVE
SOME CONCERNS ABOUT HASTENING
DEATH, OTHER PHYSICAL OR MEDICAL
HARMS, AGAIN, ESPECIALLY IN
CASES WHERE DEATH HASN'T
OCCURRED.
THEN THE CONCEPT OF DIGNITARY
HARMS, WHICH I THINK REALLY
CLOSELY CONNECTS UP TO THE
CONCEPT OF DISRESPECTFUL
TREATMENT, BUT THAT'S THE OTHER
MAJOR TYPE OF HARM THAT TENDS TO
GET DISCUSSED.
THE LAST AND I'M INCLUDING THIS
IN SUBJECT CENTER CONCERNS
BECAUSE I THINK FAMILY ARE
CLEARLY WRAPPED UP IN A
SUBJECT'S EXISTENCE AND IDENTITY
ARE IMPACT/HARMS TO FAMILY
MEMBERS, INTERFERENCE WITH DEATH
AND GRIEVING PROCESS AND HOW A
PERSON IS TREATED AT THE END OF
THEIR LIFE OR AFTER THEY DIE.
THERE'S ALSO A SET OF
NON-SUBJECT CENTERED CONCERNS,
RIGHT?
DIVERSION OF CLINICAL RESOURCES
IN TERMS OF FACILITIES,
MEDICATION, STAFF, ALL THESE ARE
ISSUES THAT KATHLEEN HAS ALREADY
STARTED TO HIGHLIGHT.
POTENTIAL CONCERNS ABOUT HARMS
TO STAFF, PARTICULARLY
INDIVIDUALS WHO HAVE OBJECTIONS
TO PROVIDING THIS TYPE OF
TREATMENT, WHO FEEL LIKE THEY
CAN'T DO THEIR OTHER JOB.
AND EROSION OF TRUST FROM THE
COMMUNITY.
WHAT WE'RE TALKING ABOUT ARE NOT
THINGS THAT MOST PEOPLE THINK
ARE HAPPENING WITH REGARD TO
TREATMENT OF DEAD PERSONS, AND
IT COULD CERTAINLY RUN THE RISK
OF UNDERMINING VIEWS OF
INSTITUTIONS AND RESEARCHERS IN
THE COMMUNITY IF IT'S THE
THOUGHT THAT PEOPLE ARE DOING
ACTIVITIES THAT ARE MORALLY
PROBLEMATIC.
AND THEN OTHER KINDS OF WORRIES
THAT THIS IS WHAT HAPPENS TO YOU
IF YOU GO TO THE HOSPITAL.
SO I'M JUST GOING TO SAY OUT
FRONT, I THINK ALL THESE CONC
CONCERNS ARE ADDRESSABLE IN
PRINCIPLE AND I'LL GO THROUGH
WHY AND THEN I WANT TO GET INTO
SOME WHAT I THINK ARE SOME OF
THE DETAILS THAT MAKE SOME OF
THEM A BIT MORE CHALLENGING.
SO IN TERMS OF THE SUBJECT
CENTER CONCERNS ABOUT
DISRESPECTFUL TREATMENT, AS I
MENTIONED, A LOT OF THAT TENDS
TO BE AROUND WHAT THE SUBJECT
WOULD HAVE WANTED.
MOST OF THOSE ISSUES ARE
ADDRESSED BY CONSENT OR
AUTHORIZATION THAT'S BASED ON
SUBSTITUTED JUDGMENT.
IN THE CASE THAT WE HEARD, THIS
WAS CLEARLY SOMETHING -- CLEARLY
AN EXAMPLE OF WHERE THE FAMILY
WAS TRYING TO APPLY WHAT THEY
KNEW ABOUT G.L. TO THIS
SITUATION.
AND SO IT'S HARD TO SAY THAT
THIS IS SOMETHING THAT THE
SUBJECT WOULDN'T HAVE WANTED
EVEN THOUGH THE SUBJECT WASN'T
THE PERSON THAT MADE THAT
DECISION.
THE OTHER WAY THAT WE THINK
ABOUT DISRESPECTFUL TREATMENT IS
THAT IT VIOLATES NORMS OF HOW WE
TREAT PERSONS OR BODIES.
I THINK IT'S IMPORTANT TO NOTE
THAT MOST OF THESE KINDS OF
NORMS IN ADDITION TO BEING ONES
WE GENERALLY LET PEOPLE MAKE
DECISIONS ABOUT FOR THEMSELVES,
MOST NORMS ARE NOT FIXED AND
THEIR EXPRESSIONINGS OF VALUES
WE HAVE AS A SOCIETY, I THINK
ORGAN DONATION IS THE PERFECT
EXAMPLE OF THAT.
THE EARLY DAYS OF ORGAN
PROCUREMENT, THAT FUNDAMENTALLY
CHALLENGED WHAT PEOPLE THOUGHT
WAS APPROPRIATE AND IS CURRENTLY
VERY MUCH WITHIN THE NORM THAT
PEOPLE THINK ABOUT WITH REGARD
TO APPROPRIATE TREATMENT OF DEAD
PERSONS.
SO I THINK IT'S KEY THAT NORMS
CAN BE CHANGED, ESPECIALLY WHEN
THEY'RE MOVED TOWARDS SOMETHING
THAT HAS AN IMPORTANT VALUE TO
SOCIETY.
IN TERMS OF HARMS TO
INDIVIDUALS, THE WORRYS ABOUT
HASTENING DEATH AND OTHER
PHYSICAL HARMS I THINK ARE
LARGELY OBVIATED BY RESTRICTION
FOR PERSONS TO WHOM THE OUTCOME
IS VERY CLEARLY CERTAIN.
DAVE AND I WERE TALKING ABOUT
THIS BEFORE.
THERE CERTAINLY IS A BIG RANGE
OF WHAT CONSTITUTES NEARLY DEAD
PERSONS, AND THAT'S WHERE WE
TEND TO THINK MORE ABOUT
POTENTIAL HARMS REGARDING HOW
THE DEATH PROCESS OCCURS OR
CONCERNS FOR POTENTIAL SUFFERING
OR OTHER KINDS OF PAIN PEOPLE
MIGHT HAVE, BUT IN GENERAL, MANY
OF THESE STUDIES RESTRICT
INCLUSION TO PERSONS FOR WHOM
THE OUTCOME IS RELATIVELY CLEAR
AND WE DON'T WORRY AS MUCH ABOUT
THOSE PHYSICAL HARMS.
IN TERMS OF DIGNITARY HARMS, I
THINK IT'S REALLY IMPORTANT TO
COME BACK TO THIS NOTION OF
AUTHORIZATION OR CONSENT.
I DO THINK WE THINK OF DIGNITY
AS BEING LARGELY RELATED TO WHAT
PEOPLE CARE ABOUT, SO IT'S VERY
DIFFICULT TO MAKE JUDGMENTS
ACROSS THE BOARD ABOUT WHAT IS
AND ISN'T A DIGNIFIED DEATH,
ESPECIALLY IN THE ABSENCE OF
KNOWING WHAT PEOPLE CARED ABOUT.
I THINK WHEN YOU THINK ABOUT THE
CASE OF G.L., MY GUESS IS FROM
WHAT WAS DESCRIBED, THIS WOULD
NOT BE A VIOLATION OF HER
DIGNITY BECAUSE, IN FACT, HER
NOTION OF WHO SHE WAS WAS
SOMEBODY WHO WANTED TO
CONTRIBUTE TO SOCIETY AND THAT'S
VERY MUCH CONSISTENT WITH THIS.
IN TERMS OF HARMS TO THE FAMILY,
THE PRIMARY WORRY AS I MENTIONED
IS ABOUT INTERFERING WITH THE
DEATH OR GRIEVING PROCESS, AND
THIS, I THINK, HAS TWO REAL WAYS
TO OBVIATE.
ONE IS, AS WE TALKED ABOUT
ALREADY, THE NOTION OF CONSENT
OR AUTHORIZATION, AND THE OTHER
IS WE HAVE A LONG EXPERIENCE
LEARNING HOW TO DEAL WITH PEOPLE
IN THESE CIRCUMSTANCES TO MEET
THEIR NEEDS FROM AN EMOTIONAL
SUPPORT PERSPECTIVE AND
UNDERSTAND THEIR EXPECTATIONS
ABOUT THE DYING PROCESS FROM
YEARS WITH ORGAN DONATION AND
PROCUREMENT.
IT DOESN'T MEAN WE HAVE THESE
ALL WRAPPED UP WITH REGARD TO
HOW TO HANDLE THESE SITUATIONS,
BUT WE CERTAINLY HAVE EXPERIENCE
TO DRAW FROM.
THE NON-SUBJECT CENTERED
CONCERNS, I THINK, ARE
INTERESTING AND TEND TO BE VERY
PRACTICAL IN THEIR FOCUS.
IN TERMS OF DIVERSION OF
RESOURCES, THIS CERTAINLY ISN'T
A UNIQUE PROBLEM IN RESEARCH.
EVERYTHING THAT WE DO THAT
INVOLVES RESEARCH THAT'S
INTEGRATED WITHIN THE CLINICAL
DELIVERY SYSTEM IN SOME WAYS
REQUIRES PRIORITIZATION AND WE
HAVE TO FIGURE OUT HOW TO MAKE
SURE WE DON'T COMPROMISE OTHER
MISSIONS, SO THERE'S A QUESTION
OF HOW MUCH WE ALLOW, HOW OFTEN
WE DO IT, HOW WE STRUCTURE IT,
BUT I DON'T THINK IT'S A
FUNDAMENTAL PROBLEM.
IN TERMS OF HARMS TO STAFF, THE
MOST STRAIGHTFORWARD SOLUTION AT
LEAST CONCEPTUALLY IS IF SOMEONE
HAS OBJECTIONS TO PARTICIPATING
IN THESE KIND OF RESEARCH, IT
PROBABLY VERY IMPORTANT.
FOR US
TO OFFER THEM OPPORTUNITIES TO
OPT OUT.
THAT DOESN'T MEAN IT'S EASY TO
IMPLEMENT BUT AT LEAST
CONCEPTUALLY, IT'S NOT A
COMPLICATED PROBLEM.
AND IN TERMS OF EROSION OF TRUST
AND COMMUNITY, THIS ALSO IS
SOMETHING THAT'S REALLY CORE TO
WHAT WE THINK ABOUT RESEARCH
ETHICS ALL THE TIME, RIGHT?
WE DO A LOT OF THINGS IN THE
CONTEXT OF RESEARCH THAT ARE
DIFFERENT FROM WHAT PEOPLE'S
EXPECTATIONS ARE.
AND IT DOESN'T MEAN THIS ISN'T A
POTENTIALLY THORNIER SET OF
ISSUES OR REQUIRES MORE WORK,
BUT I THINK USING TOOLS OF
TRANSPARENCY, GOOD
COMMUNICATION, DEMONSTRATION OF
VALUE AND PROPER ENGAGEMENT OF
STAKEHOLDERS, I DON'T KNOW THAT
THERE'S ANY REASON TO BELIEVE
THAT THIS IS A FUNDAMENTAL
PROBLEM.
SO IN ALL OF THESE CASES THOUGH
AS I'VE STARTED TO GET AT, I
THINK THE DEVIL IS IN THE
DETAILS, PROBABLY MUCH MORE SO
THAN IT IS IN BIG PICTURE
CONCEPTUAL QUESTIONS.
SO LET'S SORT OF LOOK BACK AT A
COUPLE OF THE SPECIFIC ISSUES
THAT I THINK KATHLEEN HAS RAISED
AN THAT WE TEND TO THINK ABOUT A
LOT IN THESE KIND OF CONTEXTS.
SO ONE IS THE ROLE OF CONSENT.
SO IN THIS CASE, G.L. DID NOT
PROVIDE CONSENT FOR BEING IN
THIS STUDY, BUT THE FAMILY
AUTHORIZED INCLUSION AND SOME
PEOPLE MIGHT FIND THAT
PROBLEMATIC.
ONE REASON PEOPLE MIGHT FIND
THAT PROBLEMATIC IS IN GENERAL,
WE HAVE GREATER BOUNDARIES
AROUND SURROGATE CONSENT FOR
RESEARCH THAT DOESN'T HAVE
POTENTIAL FOR DIRECT BENEFIT.
YOU LOOK AT KIDS OR OTHER
POPULATIONS THAT DON'T HAVE
CAPACITY, WE DON'T LET THEM, WE
SET RISK CAPS.
SO THE THINGS WE LET PEOPLE TO
AGREE TO THEMSELVES, WE DON'T
LET OTHERS AGREE TO FOR THEM.
BUT GENERALLY THAT'S BASED ON A
NOTION OF HEALTH RISKS, RIGHT,
WHICH ISN'T PRESENT HERE.
WE ALLOW PEOPLE, ON THE OTHER
HAND, TO MAKE DECISIONS ABOUT
ORGAN DONATION, ABOUT ALMOST
EVERY OTHER ASPECT OF HOW OUR
BODY IS TREATED AFTER DEATH AND
I DON'T REALLY SEE A REASON FOR
WHY WE WOULD MAKE A DISTINCTION
HERE.
MOREOVER, IN THIS PARTICULAR
CASE, EVERYTHING ABOUT G.L.
SEEMS CONSISTENT WITH THIS, AND
IT SEEMS TO BE A VERY GOOD
APPLICATION OF THE SUBSTITUTED
JUDGMENT.
I THINK THE BIGGER ETHICAL
CHALLENGE MIGHT BE IF YOU RUN
INTO SITUATIONS WHERE THE FAMILY
ISN'T SUPPORTIVE, BUT G.L. HAD
MADE IT VERY CLEAR THAT SHE
WANTED TO PARTICIPATE.
ONE OF THE STUDIES THAT DAVE AND
I DID YEARS AND YEARS AGO WAS
ABOUT HOW OPOs HANDLE
QUESTIONS WHEN AN INDIVIDUAL HAS
VERY CLEARLY EXPRESSED A WISH TO
DONATE AND THE FAMILY HAS
OBJECTIONS.
SO THOSE ISSUES COULD
POTENTIALLY BECOME MORE
CHALLENGING.
IN TERMS OF BOUNDARIES OF
RESPECTFUL CONDUCT, THIS STUDY
INVOLVES DOING SOMETHING THAT'S
VERY DIFFERENT FROM WHAT MOST
PEOPLE IMAGINE IF THEY WERE
BRAIN DEAD.
PERFORMING A TRANSPLANT SURGERY,
HARVESTING THE ORGAN, MECHANICAL
VENTILATION AND OTHER NECESSARY
MEDICAL INTERVENTIONS.
I THINK IT'S REALLY IMPORTANT TO
NOTE THESE ARE ALL ACCEPTED
PRACTICES WITHIN NORMAL MEDICAL
CARE AND REALLY CONSISTENT WITH
WHAT HAPPENS IN ORGAN DONATION
AND PROCUREMENT ALREADY.
IT'S DIFFICULT FOR ME TO SEE WHY
THE SPECIFIC PROCEDURES RAISE
SUBSTANTIAL QUESTIONS IN AND OF
THEMSELVES.
WHERE I THINK THE CONTROVERSY
TENDS TO BE IS MORE IN SORT OF
TWO AREAS.
ONE IS I THINK PEOPLE TEND TO BE
PARTICULARLY SENSITIVE ABOUT
RESUSCITATION, SO IF YOU WERE
DOING THIS, SO THIS IS A PERFECT
EXAMPLE, YOU DO A HEART
TRANSPLANT AND THE PATIENT GOES
INTO DEFIB RIGHT AFTERWARDS IN
THE CONTEXT OF ACUTE REJECTION,
WOULD YOU SHOCK THEM BACK?
THAT'S SOMETHING THAT SOMETIMES
PEOPLE HAVE SUGGESTED,
RESUSCITATION IS A LI LINE THAT
SHOULDN'T BE CROSSED IN THAT
CONTEXT.
I'LL SAY ESPECIALLY IN THIS
CONTEXT, I DON'T UNDERSTAND THIS
REASON.
IT'S CONSISTENT WITH WHAT WE DO
WITH A PATIENT IN THAT CONTEXT,
SO IT ACTUALLY MIGHT BE QUITE
IMPORTANT TO BE ABLE TO
UNDERSTAND HOW PEOPLE RESPOND TO
THIS.
SO I DON'T KNOW THAT THERE'S ANY
OBVIOUS BARRIER RELATED TO
RESUSCITATION.
WHERE I THINK YOU RUN INTO
PARTICULAR CONCERNS ARE WHEN WE
THINK ABOUT KINDS OF INTENTIONAL
INSULTS OR TRAUMA.
SO IMAGINE IF YOU WERE DOING
TRAUMA RESEARCH AND IT INVOLVES
A GUNSHOT WOUND, IF WE THINK
ABOUT HAVING SOMEONE AND WE HAVE
TO GO SHOOT THEM, WHILE BRAIN
DEAD, THAT'S GOING TO TURN
PEOPLE'S STOMACHS, RIGHT?
IN A WAY THAT THINGS THAT --
RAISES SOMETHING WE DON'T
NORMALLY DO.
I THINK IT'S A REALLY GOOD --
I'D LIKE US TO THINK THROUGH
CASES LIKE THAT A LITTLE BIT
MORE, ABOUT WHERE DO THE
BOUNDARIES REALLY LIE.
I THINK THE KEY DETERMINANT HAS
TO BE WHETHER IT'S JUSTIFIED BY
THE SCIENCE.
BUT I DO THINK AS I MENTIONED
EARLY ON, THERE'S A LOT OF
EXAMPLES, WHETHER PUTTING BODIES
IN TRUNKS OR USING THEM IN CRASH
TEST SIMULATIONS OR OTHER THINGS
THAT PUSH BOUNDARIES A LOT
FURTHER THAN WE MIGHT RECOGNIZE.
HOLLY'S QUESTION ABOUT LENGTH OF
TIME, RIGHT?
AND THIS IS A WEBSITE FROM THE
MIU EXPERIENCE OF THE FIRST
STUDY OF PIG KIDNEYS,
XENOTRANSPLANTATION, WHERE
SOMEONE WAS BASICALLY KEPT
PERFUSING FOR TWO MONTHS.
SO THAT'S A LONG TIME TO THINK
ABOUT ENROLLMENT TO WHEN A
FUNERAL HAPPENS FOR THAT
PATIENT.
AND I THINK IT'S A REALLY GOOD
QUESTION AND PROBABLY MAY BE THE
CENTRAL QUESTION PEOPLE THINK
ABOUT IS REALLY HOW LONG IS TOO
LONG.
IT'S NO QUESTION THE TIME FRAMES
HAVE TO BE JUSTIFIED BY THE
SCIENCE.
WHEN YOU LOOK AT THE HISTORY OF
GUIDELINES THAT HAVE BEEN
PROPOSED IN THIS SPACE, YOU SEE
EVERYTHING FROM SORT OF SEVERAL
HOURS LIKE WAS THE CASE IN THE
2B/3A STUDIES, TO SORT OF "IT
DEPENDS."
I THINK EXTENDED PERIODS OF TIME
ARE PARTICULARLY CHALLENGING
WHEN YOU THINK ABOUT THE FAMILY
PERSPECTIVE.
WE'LL CREATE A FUNDAMENTALLY
DIFFERENT PROCESS FOR DYING AND
GRIEVING.
AND MAKE IT REALLY IMPORTANT TO
BE CLEAR ABOUT WHETHER YOU ALLOW
FAMILIES TO VISIT, WHETHER
YOU -- WHAT KINDS OF UPDATES YOU
GIVE THEM.
I THINK TO JUST SAY WE'RE NOT
GOING TO DO THAT SEEMS DEEPLY
PROBLEMATIC AND DOESN'T
ACKNOWLEDGE THE WAY PEOPLE
EXPECT DEATH TO OCCUR, BUT HOW
TO MAKE THAT HAPPEN IS IMPORTANT
TO THINK THROUGH.
I THINK LONG STUDIES RUN THE
RISK OF WITHDRAWAL WHEN YOU'VE
GOT A LOT INVESTED.
YOU'VE GOT A TWO MONTH END POINT
FOR XENOTRANSPLANTATION STUDY
AND A MONTH AND A HALF IN
SOMEBODY SAYS WE'RE DONE, UNPLUG
HER.
THAT'S A DISASTER.
AND SO WE HAVE TO THINK ABOUT
THIS ESPECIALLY IN THE CONTEXT
OF STUDIES WITH VERY LONG
DURATION.
I THINK WE ALSO DON'T HAVE A LOT
OF GOOD EVIDENCE ABOUT WHAT
PEOPLE THINK AND MORE
IMPORTANTLY, WHAT PEOPLE'S
EXPERIENCES ARE IN THIS CONTEXT.
SO ONE OF THE THINGS THAT I'LL
EMPHASIZE THROUGHOUT ALL OF THIS
IS IT'S IMPORTANT TO UNDERSTAND
THAT IN THE PROCESS.
IN TERMS OF OUR INTERACTIONS,
I'VE ALREADY GONE THROUGH THIS
BEFORE, BUT WE'RE NOT STARTING
FROM SCRATCH, WE DO HAVE A LOT
OF EXPERIENCE IN HOW TO INTERACT
WITH FAMILIES OF DYING PATIENTS,
AND OBVIOUSLY HOW WE DO THIS HAS
TO BE ANCHORED IN THE SPECIFICS
OF THE PROTOCOL.
AND AGAIN, I THINK IT'S REALLY
IMPORTANT TO DO RIGOROUS
EMPIRICAL RESEARCH INTO THE
EXPERIENCES OF FAMILIES WHO HAVE
BEEN THROUGH THIS.
THERE'S LOTS OF THEORETICAL
CONCERNS AND A LOT TO DERIVE
FROM CLINICAL CON TECHS T T CONY
HOME FOR DIFFERENT OU OUTCOMES.
SO THE LOCATION OF THE RESEARCH
AND TEAM COMPOSITION, I'LL SORT
OF WRAP UP WITH THE LAST COUPLE
OF SLIDES HERE.
IT IS AN INTERESTING QUESTION
WHETHER THIS SHOULD BE DONE
WITHIN CLINICAL UNITS.
THAT'S NOT AN EASY THING TO JUST
SAY YOU SET UP AN ICU TO RUN A
STUDY OF ONE PERSON.
SO HOW TO THINK ABOUT HOW TO
GEOGRAPHICALLY LOCATE THIS IS A
REALLY IMPORTANT QUESTION IN
TERMS OF WHAT RESOURCES ARE
AVAILABLE, AND THERE'S LOTS OF
WAYS IN WHICH SEPARATION WOULD
BE DESIRABLE BUT NOT DOABLE IN
MANY FACILITIES.
YOU ALL MAY BE A UNIQUE SPACE
FOR THIS, RIGHT, IT'S A RESEARCH
HOSPITAL.
NOT EVERY HOSPITAL IS LIKE THAT.
IT MAY BE IMPORTANT TO HAVE
ISOLATED CENTERS WHERE YOU
DEVELOP EXPERTISE AND TBRUCT TO
DOINFRASTRUCTURE TO DO THIS KIND
OF WORK.
SO THE OTHER SORT OF STICKY
ISSUES HAVE TO DO WITH WHO
PROVIDES OVERSIGHT.
IT ISN'T NECESSARILY WITHIN THE
PURVIEW OF IRBs BECAUSE THE
DEFINITION OF RESEARCH AT THE
SAME TIME IS THE KINDS OF
THINGS -- SOME INSTITUTIONS HAVE
SET UP UNIQUE GROUPS TO REVIEW
THIS.
LOTS OF QUESTIONS ABOUT
TERMINOLOGY.
AND THEN I THINK MANY OF THESE
ISSUES GET TOUGHER WHEN WE THINK
ABOUT PEOPLE WHO ARE NOT DEAD
YET.
WHETHER THAT'S BECAUSE THEY'RE
UNDERGOING A TERMINAL WEAN,
WHETHER THEY HAVEN'T MET BRAIN
DEATH CRITERIA, OR EVEN
PROCESSES -- STUDIES LIKE
AUTOPSIES WHERE THE WHOLE
PROCESS IS ALTERED.
SO IN SUMMARY I HOPE TO HAVE
MADE THE CASE THAT RESEARCH LIKE
THIS IS CRITICALLY IMPORTANT,
AND I THINK THERE'S A VERY
STRONG ETHICAL CASE FOR DOING
IT.
I DON'T THINK ANY OF THE CORE
ETHICS CONCERNS ARE
INSURMOUNTABLE AND THE MOST
SIGNIFICANT SETS OF ISSUES ARE
REALLY PRACTICAL RATHER THAN
CONCEPTUAL.
STUDYING AND LEARNING FROM OUR
EXPERIENCE IS ABSOLUTELY
CRITICAL IN ORDER TO MAXIMIZE
RESPECTFUL TREATMENT OF AND THE
IMPACT ON FAMILIES AND STAFF.
WE CAN'T DO THIS WITHOUT
STUDYING IT.
AND I THINK THERE'S PROBABLY
SIGNIFICANT VALUE IN CLUSTERING
EXPERTISE OR CAPACITY FOR DOING
THIS KIND OF WORK.
SO I'LL CLOSE WITH THAT AND LOOK
FORWARD TO DISCUSSION.
[APPLAUSE]
>> THANKS, NEAL.
DID YOU WANT TO GET US STARTED,
ROBERT?
>> I HAVE A FEW THAT MAYBE WOULD
BE GOOD TO START WITH THAT ARE
ALL CLUSTERED TOGETHER ON A
SIMILAR SORT OF ISSUE
DEMARCATING LIFE AND DEATH.
SO I'LL START WITH THE FIRST
ONE.
IS THERE A CLEAR AND DISTINCT
LINE BETWEEN BRAIN DEATH AND AN
UNUSUALLY PROLONGED STATE OF
COMA?
DOES THIS COMPLICATE THE COHORT
OF POSSIBLE, QUOTE-UNQUOTE,
PARTICIPANTS?
>> I'M NOT SURE I FULLY
UNDERSTAND THE QUESTION BUT I'LL
TAKE A STAB AT IT AND MAKE SURE
THAT -- AND ANYONE, KATHLEEN OR
DAVE, JUMP IN.
I THOUGHT ABOUT HAVING A CAVEAT
SO I WASN'T GOING TO ADDRESS ANY
ISSUES RELATED TO DEATH SO MAYBE
I'LL JUST FALL BACK ON THAT, BUT
THERE'S A LOT OF QUESTIONS ABOUT
WHAT CONSTITUTES DEATH OR AS
GOOD AS DEATH OBVIOUSLY.
AND I THINK, YOU KNOW, THE BEST
I CAN SAY IS IT'S MOST
STRAIGHTFORWARD IN THE CASE OF
PATIENT WHO ARE CLEARLY -- WHO
MEET CRITERIA FOR BRAIN DEAD
BECAUSE THAT'S A VERY ACCEPTED
STANDARD.
WHAT YOU CAN DO WITHER OH
POPULATIONS REALLY DEPENDS
HEAVILY ON WHAT THE STUDY IS,
WHAT YOU THINK THAT PERSON'S
STATE IS, AND IF YOU THINK THERE
ARE POTENTIAL FOR THE INDIVIDUAL
TO HAVE DIFFERENT KINDS OF HARMS
OR PAIN OR SUFFERING,, OBVIOUSLY
A VERY DIFFERENT KETTLE OF FISH.
>> THAT'S SUPER HELPFUL.
ALSO I THINK IT MAYBE ANSWERS
THE NEXT QUESTION, WHICH IS
POINTING OUT THAT SOME LOW
GROUNDED MINORITY POSITION THAT
BRAIN DEATH IS NOT DEATH, SO
WHAT ARE THE IMPLICATIONS OF
THAT.
A THIRD QUESTION ON A SIMILAR
NOTE, THIS TIME SORT OF GOING IN
THE OTHER DIRECTION, IS --
SORRY, I'M GOING THROUGH THESE
PRESENTLY.
HOW IS SUBJECT DEFINED AND WHEN
DOES A SUBJECT NO LONGER
CONSTITUTE A DEAD PERSON WORTHY
OF ETHICAL CONCERNS, EG, DO SOME
OR ALL OF THESE ETHICAL ISSUES
ALSO APPLY TO TISSUE OR CELL
LINES LIKE HELA CELLS?
>> I GUESS -- I'LL TRY TO ANSWER
THE PIECE OF THAT THAT I THINK
IS MOST CONNECTED TO THIS, WHICH
IS THAT AT LEAST IN PRINCIPLE,
AS DAVE MENTIONED IN THE
INTRODUCTION, PEOPLE WHO MEET
OUR CRITERIA FOR BRAIN DEATH,
FOR EXAMPLE, ARE NOT HAVING
EXPERIENCES, AND YET I THINK ALL
OF US WOULD SAY THAT THESE KINDS
OF ACTIVITIES HAVE IMPORTANT
BEARING ON THE NARRATIVE OF
THEIR LIFE, RIGHT?
AND SO THE EXTENT TO WHICH
SOMEONE EXPRESSED PREFERENCES
ABOUT WANTING TO CONTRIBUTE IN
CERTAIN WAYS, THE EXTENT TO
WHICH -- HOW THEY ARE IN DEATH
REFLECT WHO THEY WERE IN LIFE, I
THINK THERE'S AN ELEMENT OF THEM
THAT'S REALLY RELEVANT TO WHAT
WE DO TO THEM AFTER THEY MEET
CRITERIA FOR DEATH.
I THINK THE EXTENT TO WHICH --
SO I THINK THESE FEEL MORE
EXPERIENTIAL AND MORE CLOSELY
CONNECTED TO THE PERSON THAN
MANY OF THE ISSUES ABOUT HOW
DATA IS USED OR HOW PART ARE U
USED LATER, SO I THINK THIS HAS
A MUCH MORE KIND OF EMOTIONAL
CONNECTION TO THE INDIVIDUAL.
ALTHOUGH THE BASIC NOTION OF
SOMEONE'S KIND OF LIFE STORY
BEING RELEVANT TO WHAT HAPPENS
TO THEM AFTERWARDS, I THINK
OVERLAPS.
EXPWR THANKS.
>> THANKS.
I'LL TAKE A TURN OFF THE MIC
NOW.
>> I'LL JUST FOLLOW UP AS THE
NEXT PERSON IS COMING IS, JUST A
TERMINOLOGY POINT.
THERE'S BEEN A BIG SHIFT IN
RESEARCH ETHICS FROM SUBJECTS TO
PARTICIPANTS.
AND THE IDEA IS THAT'S SUPPOSED
TO SIGNAL THAT THE INDIVIDUALS
WHO ARE INVOLVED IN RESEARCH
AREN'T JUST PASSIVE SUBJECTS OF
THINGS BEING DONE TO THEM, BUT
THEY'RE ACTIVELY CONTRIBUTING IN
SOME SENSE.
WHEN YOU DECIDED SUBJECTS, I WAS
WONDERING, DID YOU HAVE THAT IN
MIND AND WERE YOU THINKING
SUBJECTS IS JUST MORE
APPROPRIATE ONCE THEY'RE DEAD,
OR I JUST WASN'T GOING TO THINK
ABOUT THIS AND I DON'T KNOW?
>> YEAH, I WAS TRYING TO NOT
THINK ABOUT IT.
I MEAN, THE TRUTH IS, YOU
COULD -- IN A MEANINGFUL WAY,
THIS CASE THAT WE JUSTED -- G.L.
IS IN SOME WAYS PARTICIPATING IN
THE SENSE THAT THE FAMILY
ALLOWED HER BODY TO BE INCLUDED
BECAUSE THAT'S WHO SHE WAS, AND
THEY FELT LIKE THIS WAS A WAY TO
ENACT WHAT SHE WANTED HER STORY
TO BE, AND SO I DON'T MEAN TO
DEVALUE THAT.
I THINK TO ME, SUBJECT CARRIES
LESS IN THE SENSE THAT IT
DOESN'T -- THERE ISN'T AN
ONGOING EXPERIENCER IN THIS
CASE, SO PARTICIPANT IMPLIES AN
ONGOING LEVEL OF ENGAGEMENT.
I THINK THAT'S PART OF THE
REASON WE USE THAT.
IT'S NOT JUST BECAUSE PEOPLE
HAVE SORT OF THINGS AT STAKE BUT
BECAUSE WE'RE SUPPOSED TO BE
INTERACTING WITH PEOPLE IN
IMPORTANT WAYS.
I DON'T THINK PEOPLE WHO MEET
CRITERIA FOR BRAIN DEATH CAN
ENGAGE WITH US IN THE SAME WAY
AS PEOPLE WHO ARE CLEARLY LIV
LIVING.
BUT I DIDN'T MEAN TO DEVALUE THE
NOTION THAT IF WE'RE GETTING
SOME FORM OF CONSENT OR
AUTHORIZATION AND WE'RE
PRETENDING -- NOT PRETENDING --
WE ARE BELIEVING THAT THIS WAS A
REFLECTION OF WHAT THEY WANTED,
THAT THEY IN SOME SENSE HAD SOME
AGENCY IN THIS PIECE.
BUT I THINK IT'S MUCH MORE
STRAIGHTFORWARD TO TALK ABOUT
THEM AS SUBJECTS BECAUSE LESS
IS -- TO ME LESS IS SORT OF
CONVEYED BY THAT.
MAYBE THAT'S NOT SUFFICIENTLY
PRECISE.
WE CAN COME UP WITH A DIFFERENT
WORD.
NEOMORT SOUNDS BAD.
>> I WAS GOING TO SUGGEST --
THAT SOUNDS TERRIBLE.
>> SO TOTALLY WITH YOU ON THE
SUBJECT RELATED ISSUES, AND I
JUST WANT TO PUSH A BIT ON THE
QUESTION OF TIME AND HOW SIMILAR
THIS IS TO ORGAN DONATION.
SO I'M GOING TO ASSUME THAT YOU
DON'T PERFUSE SOMEONE FOR UP TO
TWO MONTHS FOR ORGAN DONATION,
AND I'M GOING TO ASSUME THAT'S
RELATIVELY QUICK.
I DON'T KNOW BUT I'M GUESSING
THAT MAYBE -- IS IT THE CASE,
THIS MAY BE A QUESTION BUT --
WHETHER THE ICU STAFF IS TASKED
TO KEEPING THAT PERSON ALIVE
UNTIL THE PERSON COMING TO
PROCURE THE ORGANS ARRIVE.
I'LL SET THAT ASIDE.
SO THE THING I WANTED TO ASK YOU
ABOUT IS, FROM AN ORGAN DONATION
PERSPECTIVE, IF I'M A STAFF
MEMBER INVOLVED HERE, I KNOW
THAT BY FACILITATING ORGAN
DONATION, I'M GOING TO BENEFIT
IDENTIFIABLE HUMANS WITH THOSE
ORGANS.
VERSUS, YOU KNOW, SURE, THERE
MIGHT BE SOME LONG-TERM SOCIAL
VALUE IN MY FACILITATING THIS
BODY TO CONTINUE TO BE ALIVE TO
TEST THIS, BUT IS THERE ANY
CONCEPTUAL DIFFERENCE THERE OR
IS THAT REALLY MORE ABOUT MY
PERSONAL VALUES AS A PROVIDER?
IS THAT SOMETHING WE SHOULD BE
THINKING ABOUT OR NOT?
>> SO GREAT QUESTIONS.
I THINK WITH JUST TO CONCRETELY
ANSWER, ORDERS OF MAGNITUDE
DIFFERENT, BUT OFTEN FOR MOST
PROCUREMENT E YOU'RE LOOKING ATA
MATTER OF DAYS SOMETIMES BUT
YOU'RE NOT LOOKING AT MONTHS.
THAT PART IS DEFINITELY
DIFFERENT.
I THINK THIS ISSUE OF THE SORT
OF DIRECTNESS, IT'S NOT THE
BENEFIT BUT THE DIRECTNESS OF A
POSITIVE OUTCOME, HOW LIKELY IS
SOMEBODY GOING TO BE HELPED BY
AN INDIVIDUAL SUBJECT'S
INVOLVEMENT.
TO ME, THAT ALSO IS SORT OF AN
ISSUE OF MAGNITUDE AND NOT A
CONCEPTUAL DISTINCTION.
I MEAN, THE REASON WHY WE THINK
PEOPLE OUGHT TO IN MANY CASES
WANT TO CONTRIBUTE TO RESEARCH
IS BECAUSE WE ALL BELIEVE THAT
RESEARCH IS THE WAY WE MAKE
PROGRESS AND PEOPLE ARE GOING TO
BE HELPED, SO I THINK THIS
FALLS -- THAT REASONING IS VERY
MUCH IN LINE WITH WHY PEOPLE
DONATE ORGANS.
THERE'S A MORE DIRECT
CONNECTION, THERE'S A MORE
IMMEDIATE POSITIVE BENEFIT, AND
IN A BIG PICTURE WAY, I DON'T
SEE A REASON FOR A SORT OF
BRIGHT CONCEPTUAL DISTINCTION
BETWEEN THOSE TWO.
>> I THINK I WAS THINKING ABOUT
POTENTIAL -- [INAUDIBLE] AMONG
THE STAFF THERE IN TERMS OF HOW
THE PROCESS [INAUDIBLE]
>> I THINK THAT'S REALLY
IMPORTANT.
>> SORRY, THAT DOESN'T GET
PICKED UP ONLINE.
SORRY.
PLEASE REPEAT.
>> I WAS GOING TO SAY, THE
LATTER PART OF THE QUESTION WAS
REALLY FOCUSED ON THE POTENTIAL
FOR MORAL DISTRESS ON THE PART
OF STAFF WHO MIGHT BE INVOLVED
IN, AGAIN, CARING IS ONE OF
THOSE WORDS THAT WE DON'T KNOW
WHAT TO DO WITH, BUT ATTENDING
TO, PROVIDING INTERVENTIONS TO
PEOPLE WHO ARE BEING SUSTAINED
IN THIS WAY.
YOU CAN SEE THAT BEING AN EASIER
SELL FOR ORGAN DONATION
PROCUREMENT THAN IT MIGHT BE FOR
RESEARCH PARTICIPATION.
I THINK, YOU KNOW, ALL OF THESE
THINGS ADD UP TO THE IDEA THAT
WE WOULD SAY IF YOU'RE AN ICU
NURSE OR AN ICU DOC AND YOU'RE
LIKE, I WON'T PARTICIPATE IN
HELPING TO SUSTAIN SOMEONE FOR
ORGAN PROCUREMENT, WE'D SAY YOU
PROBABLY NEED TO FIND A NEW LINE
OF WORK.
THAT'S PART OF WHAT IT IS TO BE
IN ICU FOR THE MOST PART.
THERE'S SOME CASES NOW WITH
REGARD TO, YOU KNOW, NRP AND
OTHER KINDS OF THINGS THAT MIGHT
RAISE CONCERNS LIKE THAT, SO
MAYBE IT'S NOT CA CATEGORICALLY
DIFFERENT, AND THERE MAY BE
PEOPLE THAT DON'T PARTICIPATE IN
THOSE KINDS OF THINGS.
BUT I THINK BECAUSE OF THE
DIRECTNESS OF THE LIKELY IMPACT,
AND BECAUSE OF THE FREQUENCY AND
BECAUSE OF ALL THOSE
CONSIDERATIONS, IT'S GOING TO BE
EASIER TO CARVE OUT EXCEPTIONS
TO SAY SOMEONE DOESN'T
NECESSARILY HAVE TO PARTICIPATE
IN ACTIVITIES LIKE THIS.
I THINK THAT'S A WORKABLE
PRACTICAL PROBLEM.
AND I THINK WHAT WE'RE GOING TO
PUSH ON -- THE PUSH IS GOING TO
BE LESS IN THIS CONTEXT THAN
THERE WOULD BE IN ROUTINE ORGAN
PROCUREMENT.
>> IT INTERESTING FOR HOLLY'S
SECOND QUESTION, WE'VE DONE A
COUPLE SURVEYS WHERE WE GAVE
PEOPLE OPTIONS.
WOULD YOU PREFER TO GIVE A BLOOD
DONATION, WOULD YOU PREFER TO DO
SOMETHING AFTER WORK FOR A
CHARITY TO HELP SOME PERSON, OR
WOULD YOU PREFER TO PARTICIPATE
IN A RESEARCH TRIAL?
AND PEOPLE'S VIEWS ARE VERY
DIVERSE ON THAT.
BUT IT'S INTERESTING, WHEN YOU
ASK THEM WHY, THE PEOPLE WHO
LIKE THE BLOOD DONATION AND THE
CHARITY WILL SAY, I LIKE TO KNOW
THE PEOPLE THAT I'M HELPING,
ANDANDTHE PEOPLE WILL SAY RESEAH
WILL SAY IF I DO THOSE THINGS
I'LL HELP ONE OR TWO PEOPLE, BUT
IF I HELP IN RESEARCH, YOU CAN
HELP THOUSAND HUNDREDS OR THOUSF
PEOPLE.
YOU DON'T GET THAT CHANCE IN
LIFE.
>> I HAVE OTHER PEOPLE I TRY TO
FEEL LIKE I MAKE A DIFFERENCE ON
IN A BROADWAY.
BROAD WAY.
>> JASMINE?
>> THANK YOU VERY MUCH FOR THIS,
AND I THINK THIS IS GOING TO BE
A NICE FOLLOW-UP ON THIS
DISCUSSION THAT WE WERE JUST
HAVING BECAUSE I FEEL THE PULL,
BUT I THINK A LOT OF PEOPLE ARE
GOING TO THINK THERE'S SOMETHING
DIFFERENT ABOUT DONATING THEIR
ORGANS VERSUS DONATING TO
SCIENCE, AND SO I WAS WONDERING
IF YOU THINK IN LIGHT OF THAT
DIFFERENCE HOW OR IF WE OUGHT TO
BE SOLICITING AND ASSESSING
PEOPLE'S PREFERENCES, OUGHT WE
TO JUST SAY, OH, LOOK, THEY'RE
AN ORGAN DOUGH NAR, DONOR, THIE
TOO, OR ON YOUR LICENSE YOU'RE
ASKED ABOUT ORGANS AND DONATING
FOR SCIENTIFIC RESEARCH.
>> SO SO SO GREAT QUESTION.
AS I MENTIONED, THIS WAS
SOMETHING DAVE AND I THOUGHT
ABOUT A LONG TIME AGO, WAS SORT
OF WHAT TO DO WITH DIFFERENT
KINDS OF REQUESTS FOR DONATING
ORGANS AND HOW TO WEIGH THEM.
SO I GUESS I HAVE A COUPLE
WORRIES ABOUT THIS.
ONE OF THE OTHER THINGS I DO, I
THINK A LOT ABOUT EMERGENCY
RESEARCH AND THIS HAS COME UP IN
THE CONTEXT OF EMERGENCY
RESEARCH TOO, JUST LET PEOPLE
SAY WHETHER YOU'RE WILLING TO BE
PART OF A STUDY.
MY BIGGEST CONCERN IS ABOUT THE
DECISION PEOPLE WOULD ACTUALLY
BE MAKING AND THE UNDERSTANDING
THEY HAVE ABOUT WHAT THAT MEANS.
SO JUST WITHIN THIS DISCUSSION,
WE'VE TALKED ABOUT AN EXAMPLE OF
SOMEONE GETTING A 2A3B
INHIBITOR, HAVING LABS DONE
MAKING SURE THEY DON'T BLEED FOR
HOURS VERSUS SOMEONE BEING
SUSTAINED FOR TWO MONTHS.
THOSE ARE RADICALLY DIFFERENT.
AND MY GUESS IS MOST PEOPLE, IF
YOU LOOK AT PEOPLE THAT ARE
GOING TO HAVE PREFERENCES ALL
ALONG THAT SPECTRUM, AND IF YOU
HAVE SITUATIONS LIKE AN OPTION
TO PARTICIPATE IN RESEARCH ON
YOUR DRIVER'S LICENSE, PEOPLE
ARE GOING TO HAVE VERY DIFFERENT
KINDS OF CASES IN MIND.
ALL STUDIES ARE DIFFERENT.
AND I REALLY WORRY ABOUT ASKING
PEOPLE'S PREFERENCES WHEN THEY
DON'T HAVE A CASE THAT THEY'RE
THINKING ABOUT.
FOR THE MOST PART, I THINK
PEOPLE KNOW WHAT ORGAN DONATION
IS ABOUT.
THEY KNOW WHAT THE ORGAN -- THEY
MAY NOT KNOW THE PARTICULARS OF
WHO GETS ORGAN, THEY MAY NOT
KNOW PARTICULARS OF WHICH ORGANS
ARE TAKEN, BUT I THINK PEOPLE
HAVE A BETTER SENSE OF THE
DECISION THEY'RE MAKING.
AND I DON'T THINK IT'S A GOOD
IDEA TO ASK PEOPLE ABOUT THEIR
RESEARCH PREFERENCES WHEN
PEOPLE'S BASELINE -- THE CASES
THAT PEOPLE ARE GOING TO BE
OPERATING FROM ARE SO VERY
DIFFERENT.
I THINK THAT WOULD PROBABLY
SHOOT US IN THE FOOT.
>> LOOKS LIKE THERE'S MORE SO
WE'RE OUT OF TIME SO APOLOGIZE
TO THE ONLINE PEOPLE, ROBERT
WILL FORWARD THOSE TO ME AND
I'LL TRY TO GET TO THEM LATER
THIS AFTERNOON.
HOPEFULLY WE'LL SEE PEOPLE HERE,
FIRST WEDNESDAY IN OCTOBER,
FIRST WEDNESDAY IN DECEMBER.
STICK AROUND FOR THOSE.
IN THE MEANTIME, THANKS VERY
MUCH TO KATHLEEN AND NEAL FOR A
GREAT SESSION. 1940 01:00:13,509 [APPLAUSE]