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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.
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tomorrow's cures.
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I WOULD LIKE TO WELCOME
EVERYBODY TO TODAY'S ETHICS
GRAND ROUNDS.
I'M DAVE FROM THE
DEPARTMENT OF BIOTICS AT THE NIH
CLINICAL CENTER, OUR DEPARTMENT
HOSTS ETHICS GRAND ROUNDS 4
TIMES A YEAR AND THE GOAL OF
THESE SESSIONS IS TO PRESENT AND
OFFER AN OPPORTUNITY TO DISCUSS
IMPORTANT ETHICAL ISSUES BOTH IN
CLINICAL CARE, CLINICAL RESEARCH
AND ALSO IN BIOETHICS MORE
GENERALLY.
WE WILL TALK ABOUT THE
ETHICS OF CLINICAL RESEARCH AND
CLINICAL CARE WITH INDIVIDUALS
WHO ARE IN POLICE CUSTODY.
SO AS EVERYBODY WHO STUDIES THE
ETHICS OF CLINICAL CARE RESEARCH
FOR A BRIEF TIME KNOWS THAT
INFORMED CONCEPT IS A CRITICAL
ETHICAL APPROPRIATE TO BOTH
APPROPRIATE CLINICAL CARE AND
APPROPRIATE RESEARCH.
TYPICALLY WHEN WE THINK ABOUT
DRAWBACKS, CHALLENGES TO INFORM
CONSENT, WE FOCUSED ON THE
INFORMED PART THAT PEOPLE MAYBE
DON'T NEED TO UNDERSTAND AS MUCH
AS THEY CAN, THAT'S 1 SIDE BUT
THERE'S ANOTHER SIDE TO INFORMED
CONSENT, VALID CONSENT WHICH
DOESN'T GET AS MUCH ATTENTION AS
IT SHOULD AND THAT'S THE
VOLUNTARY PART, IT HAS TO BE
VOLUNTARY WHETHER IT'S FOR
CLINICAL CARE OR RESEARCH AND
THAT'S THE ASPECT WE WILL FOCUS
ON TODAY, SO WHAT ARE THE
CHALLENGES WHEN YOU HAVE
SOMEBODY WHO'S IN POLICE
CUSTODY, CAN YOU STILL GET AND
HOW CAN YOU GET VOLUNTARY
CONSENT FOR EITHER THE CLINICAL
CARE FOR THAT ENROLLMENT IN
RESEARCH.
I WILL JUST SAY BRIEFLY I MIGHT
HEAR MORE ABOUT THIS AS WE GO
ALONG FROM OUR SPEAKERS, AS SOME
PEOPLE KNOW, IN THE 40S, 50S,
60S, A LOT OF RESEARCH WAS
CONDUCTED ON INDIVIDUALS IN
PRISONS, THEY WERE LITERALLY A
CAPTIVE POPULATION, THERE WERE
CONCERNS THAT THAT WAS LEADING
TO,A BIEWSS AND STARRED STARTING
IN THE 70S THERE WERE STRICT
REGULATIONS ON RESEARCH AND
PRISONERS, THOSE REGULATIONS ARE
STRICT.
THEY ARE MUCH AREOT SIDE OF
PROTECTING SUBJECTS AND THEY DO
THAT OFTEN BY NOT PERMITTING A
LOST RESEARCH AND SO THAT RAISES
CHALLENGES TO WHAT EXTENT DOES
THIS QUALIFY AS PRISONERS, DO
THE REGULATIONS APPLY TO THEM
AND THEN WHAT DO WE DO
PARTICULARLY IN A SETTING WHERE
GETTING SOME CARE IN THE CONTEXT
OF CONSENT.
SO THESE ARE THE QUESTIONS OF
THE DAY.
TO LEAD US OFF IS DAVID LANG,
DAVID IS A PHYSICIAN AT THE NIH
CLINICAL CENTER, HE IS IN THE
OFFICE OF THE CHIEF OF PATIENT
SAFETY AND QUALITY.
SO DAVID WILL PRESENT THE CASE
AND AFTER THAT TO DISCUSS THE
ETHICAL ISSUES RAISED BY THE
CASE AND WE WERE JUST TALKING
STEPHEN WILL ANSWER ABSOLUTELY
EVERY ETHICAL QUESTION WE WOULD
THROW AT HIM TODAY, HE'S
PROMISED THAT'S WHAT HE'S
GETTING PAID FOR, JUST MAKING
THAT UP, SORRY.
AND STEPHEN ROSENFELD, HE HAS
WORN MORE HATSA THAN I CAN
KOWNLT, HE'S TRAINED AS A
HEMEATOLOGYIST, SPENT 19 YEARS
AT THE IN, IH CLINICAL CENTER,
HE WAS A BASIC RESEARCHER FOR A
WHILE, HE WAS A CLINICAL
RESEARCHER FOR A WHILE AND WENT
INTO ADMINISTRATION AND HE ENDED
UP WITH HIS TIME AT THE NIH AS
THE CHIEF INFORMATION OFFICER OF
THE CLINICAL CENTER.
SINCE THEN HE'S GONE ON TO
SOMETHING EVEN DIFFERENT AND NEW
WHICH MAY BE SOMEDAY WILL BE A
DIFFERENT ETHICS AND GRAND
ROUNDS.
AS SOME PEOPLE KNOW THERE ARE
WORRIES ABOUT CONFLICTS OF
INTEREST WITH ETHICS REVIEW AND
IRB REVIEW, AT LEAST IN THE
UNITED STATES.
SO IN THE UNITED STATES, MOST
IRBs ARE EITHER
INSTITUTIONALLY BASED, FOR
INSTANCE THE NIH IRBs ARE
AFFILIATED WITH THE NIH OR FOR
PROVEIS INDEPENDENT IRBs, AT
LEAST SOME PEOPLE WORRY, THAT
THOSE POTENTIAL AFFILIATIONS MAY
LEAD TO CONFLICTS THAT LEAD THE
CHALLENGES, CONCERNS WITH THE
REVIEW, STEPHEN IS TRYING TO
ADDRESS THOSE IN A VERY
PRACTICAL WAY BY STARTING AN IRB
THAT IS INDEPENDENT BUT NOT FOR
PROFIT AND MAYBE WE WILL DRAG
THEM BACK SOMEDAY TO TELL US
ABOUT THAT EXPERIENCE, BUT FOR
TODAY, IT'S ABOUT THE ETHICS OF
RESEARCH AND CARE WITH
INDIVIDUALS IN CUSTODY AND TO
GET US STARTED IS DAVID LANG.
OVER TO YOU DAVID.
>>THANK YOU VERY MUCH DAVE.
HAPPY TO BE HERE, I WOULD LIKE
TO THANK EVERYBODY FOR
PARTICIPATING IN TODAY'S GRAND
ROUNDS AND FOR TUNING IN.
JUST SHARING MY SCREEN.
HAS MY SCREEN COME UP?
YES.
>>YOU LOOK GOOD.
>>CAN YOU MAXIMIZE IT,
EVERYTHING LOOKS GOOD FROM MY
END.
>>FANTASTIC, THANK YOU SO MUCH,
ALSO AGAIN, THANK YOU EVERYBODY
FOR JOINING TODAY AND FOR THE
KIND INTRODUCTION.
I DON'T HAVE ANY CONFLICT OF
INTEREST WITH RESPECT TO THE
PRESENT PRESENTATION.
THIS WILL BE A CASE OF A PATIENT
SOME OF THE DETAILS THAT ARE NOT
RELEVANT TO THE QUESTION HAVE
BEEN MINIMIZED OR REMOVED OR
ANONYMIZED AND THE
PATIENT'S--THIS IS NOT THE
PATIENT'S REAL INITIALS SO THE
THIS HAS ALL BEEN ANONYMIZED.
OUR LEARNING OBJECTIVES TODAY IS
TO DESCRIBE A CASE OF AN
INDIVIDUAL IN POLICE CUSTODY WHO
NEEDED MEDICAL CARE AND CONSIDER
THE ETHICAL CHALLENGES THAT DAVE
WENDLER JUST TEED UP A BIT ABOUT
THE CASE AND TO DISCUSS WHEN THE
RESOURCE REGULATIONS WOULD APPLY
TO A PERSON WHO IS IN POLICE
CUSTODY.
SO THE PATIENT WE'LL IDENTIFY AS
D. L., MIDDLE AGED MAN DIAGNOSE
WIDE AN ACQUIRED IMMUNE
DEFICIENCY IN 2009, THIS WAS ALL
BEFORE HE CAME TO THE NIH.
HE LIVES WITH RELATIVES AND ALSO
IS INTERMITTENTLY HOMELESS
EITHER LIVING ON THE STREETS OR
IN SHELTERS AND DUE TO THIS, IT
IS SOMETIMES DIFFICULT OR
FREQUENTLY DIFFICULT TO
COMMUNICATE WITH HIM SUCH AS YOU
KNOW, REACHING HIM BY TELEPHONE
MIGHT HAVE US LEAVING MESSAGES
AT PLACES HE DOESN'T STAY
ANYMORE.
SO UNSTABLE COMMUNICATION.
INITIALLY HAD DEVELOPED LESIONS
AND SORENESS OF HIS LEFT LEG IN
2020 WAS IN A HOSPITAL WHERE A
SOFT TISSUE MALIGNANCY WAS
DIAGNOSED TOWARDS THE END EVER
TWEBT 20 AND HE WAS STARTED ON
MEDICATION FOR HIV.
IN THE SUBSEQUENT MONTHS HE
CONTINUED TO BE SEEN AT THE
OUTSIDE HOSPITALS AND HE HAD
THINGS SUCH AS FATIGUE, WEAKNESS
AND LEG PAIN AND WAS EVENTUALLY
REFERRED TO THE NIH CLINICAL
CENTER TO SCR EVALUATIONS AND
EVALUATION OF THIS MA ILLUMINATE
NANCY.
HE ENROLL INDEED A RESEARCH
PROTOCOL WHICH WAS DESIGNED TO
PROVIDE MEDICAL TREATMENT CADRE
OF PATIENTS FOR TRAINING AND A
REPOSITORY OF INFORMATION BASED
ON THESE PATIENTS.
THERE IS NO INVESTIGATIONAL
THERAPIES INVOLVED IN THE
PROTOCOL AND HE SEPARATELY
ENROLLED ON A PROTOCOL WHICH
WOULD LOW US TO USE BLOOD,
SAMPLES FOR RESEARCH AND TO TAKE
TISSUE SPECIMENS FROM PROCEDURES
OTHERWISE PERFORMED FOR MEDICAL
REASONS THAT ARK DITIONAL TISSUE
COULD BE USED FOR RESEARCH.
SO FOR APPROXIMATELY 2 MONTHS
DURING WHICH HE HAD A LYMPHOID
BIOPSY, TREATMENT FOR HA
LIGNANCY, FOR HIV AND CARE.
THE TREATMENT FOR SUPPORTIVE
CARE.
HE ALSO HAD A SOCIAL SERVICE
PERSON AND HE THERE WAS A PLAN
FOR DISCHARGE TO FOLLOW UP AT
THE NIH FOR EACH MONTH FOR
TREATMENT FOR THE CONTINUATION
OF CHEMO THERAPY.
SO HE DID RETURN EACH MONTH FOR
THE FIRST 2 MONTHS AFTER HE WAS
DISCHARGED AT THAT TIME THE LEG
LESION WAS IMPROVING, HE DID
REPORT HE WAS UNABLE TO TAKE HIS
PAIN MEDICATION BECAUSE IT WAS
UPSETTING HIS STOMACH AND HAVING
SUBSIDIARY QUEBT PAIN BUT
OTHERWISE THE LESION WAS
IMPROVING SO HE RECEIVED CHEMO
THERAPY THAT TIME AS SCHEDULED
AND THERE WAS A PLAN FOR HIM TO
RETURN 2 WEEKS LATER AND THERE
WAS DISCUSSION OF YOU KNOW
ALTASD MATE NOR DIFFERENT
THERAPIES BE APPROPRIATE.
HOWEVER, HE WAS EXPECTED 2 WEEKS
LATER AND DID NOT RETURN FOR 2
MONTHS SO EVENTUALLY, THE TEAM
WAS
WAS ABLE TO CONTACT HIM BY A
SOCIAL WORKER AND HE WAS ABLE TO
REESTABLISH WITH THE NIH SO AN
APPOINTMENT WAS MADE FOR HIM TO
COME BACK AND GET WITH HIS TEAM.
BETWEEN THE TIME HE MADE A DATE
AND BEING TREATED HE WAS
ADMITTED TO AN OUTSIDE HOSPITAL
WITH FEVER, LEG PAIN AND
SWELLING.
AT THAT HE WAS STARTED ON
ANTIBIOTIC TREATMENT FOR
CELLULITIS, IT WAS DISCONTINUED
WHEN THEY DETERMINED IT WAS A
WORSENING OF HIS SOFT TISSUE
MALIGNANCY.
SO THEY CALLED THE NIH TEAM AND
ASKED IF HE COULD RETURN HERE
FOR TREATMENT WHICH THE MEDICAL
TEAM AGREED, HE WAS DISCHARGED
FROM THE OTHER HOSPITAL AND WAS
TRANSPORTED HERE BY TAXICAB.
ON ARRIVAL THE NIH GATE, HE WAS
DETAINED BECAUSE WHEN HE STATED
HIS NAME THERE WAS AN
OUTSTANDING WARRANT FOR HIM BY
THE NIH POLICE FOR ALLEGE THEFT
THAT OCCURRED ON THE NIH CAMPUS
A PRIOR TIME HE WAS HERE, WHILE
HE'S BEING PROCESSED ISSUES THE
POLICE DISCOVERED ANOTHER
WARRANT FROM ANOTHER COUNTY THAT
WAS ALSO OUTSTANDING.
SO, THE NIH POLICE BY THEIR
PROTOCOL CONTACTED THE ATTENDING
PHYSICIAN WHO'S SUPPOSED TO BE
SEEN HERE WHO DOES SAY YES, HE'S
SUPPOSED TO BE COMING HERE FOR
TREATMENT, HE NEEDS TREATMENT
FOR HIS MA LIGGING NANCY BUT
ALSO NEEDS EVALUATION FOR
POSSIBLE DEEP VEIN THROMBOSIS,
SO AFTER ADMISSION BROUGHT TO
THE CLINICAL CENTER BECAUSE IT
WAS MEDICALLY NECESSARY UNDER
POLICE CUSTODY.
HE WAS THEN HOSPITALIZED AT THE
NIH HOSPITAL CENTER FOR 10 DAYS
AND UNDER POLICE CAN CUSTODY FOR
FIRST 2 DAYS, WHILE HE WAS IN
THE IN-PATIENT UNIT FOR THE
FIRST 2 DAYS UNTIL THERE WAS
SOME CLEAR UP THINGS WITH THE
WARRANT, SO THERE WAS PERMISSION
TO NOT HAVE HIM BE UNDER POLICE
CUSTODY.
WHILE HE WAS HERE HE GOT HIS
NEXT CYCLE OF CHEMO HER TAPY AND
WHILE HE WAS HERE, THERE WERE
PLANS MADE FOR HIM AND HE WAS
GOING TO BE DISCHARGED AND ON
THE DAY OF DISCHARGE HE LEFT THE
CLINICAL CENTER BEFORE HE WAS
ABLE TO PICK UP HIS MEDICATIONS
AND BEFORE THE NIH POLICE WERE
ABLE TO COME AND SPEAK WITH HIM
BEFORE THE NEXT STEPS AS FAR AS
THE WARRANTS.
SO THE NIH SOCIAL WORKER CALLED
HIM ONCE SHE WAS ABLE TO CONTACT
HIM HE STATED THAT HE FELT THAT
THE NIH TRAPPED HIM INTO COMING
UP HERE BECAUSE HE THOUGHT THE
NIH TEAM WOULD HAVE KNOWN THOSE
WARRANTS WOULD LIKELY RESULT IN
HIS ARREST AND HE FELT TRAPPED.
THE SOCIAL WORKERS STATED THEY
HAD WERE TOTAL UNAWARE OF THE
WARRANTS UNTIL HE GOT HERE AND
THEY WERE CONTACTED ABOUT THEM
AND THEY HAD ACCEPTED HIM FOR
THE MEDICAL TREATMENT AND THEY
DIDN'T KNOW ANYTHING ABOUT HIS
LEGAL PROBLEMS OR ISSUES.
AT THE TIME THEY CONTINUE TO
WORK WITH HIM AND HELP HIM WITH
ACCESSING LOCAL HOUSING AND
SOCIAL SERVICES AND MEDICAL
CARE.
SO THIS LED TO SOME QUESTIONS,
BECAUSE WE'RE HONESTLY NOT USED
TO HAVING A PATIENT WHO'S UNDER
ARREST HERE AT THE CLINICAL
CENTER AND THE FIRST WAS DOES
THIS AFFECT HOW ANY CLINICAL
CARE IS PROVIDED TO INDIVIDUALS
UNDER ARREST AND HIM BEING IN
CUSTODY OR BEING UNDER ARREST
INFLUENCE ANY SPECIFIC ISSUES
LIKE IS HE ABLE TO CONSENT FOR
INVASIVE PROCEDURES, OR OTHER
SAFE GUARDS NEED TO BE TAKEN.
IF HE WERE TO SAY, I WANT TO BE
DNR, WOULD THERE BE ANY OTHER
PROCEDURES THAT NEED TO BE TAKEN
CARE OF LIKE THAT.
RELATING TO RESEARCH, DO THE
REGULATIONS WHICH APPLY TO
RESEARCH ON PRISONERS APPLY TO
IA PERSON WHO'S SORT OF JUST
BEEN ARRESTED AT THE TIME.
IS THE CLINICAL CENTER,A LOWED
TO PROCEED WITH THE RESEARCH
PROTOCOL WITH A PERSON WHO HAS
BEEN ARRESTED AND WOULD IT
MATTER IF THAT PATIENT WAS
ALREADY AN ESTABLISHED CLINICAL
CENTER PATIENT, A SLIGHT TWIST
ON THIS STORY, NOT THE STORY I
JUST PRESENTED BUT A
HYPOTHETICAL, LET'S SAY A
PATIENT HAD BEEN GOING ON A
TREATMENT PROTOCOL THAT REQUIRED
MULTIPLE PSYCHEETS AND
TREATMENTS AT INTERVALS AND IN
BETWEEN 1 OF THE INTERVALS AND
THE NEXT, OUTSIDE OF THE NIHY
HOO HAD BEEN ARRESTED AND HE
LEARNED THAT HE WAS IN JAIL, IF
HE WAS ABLE TO COME WOULD WE BE
ALLOWED TO DO THAT.
AND IF--DOES IT MATTER IF THE
PROTOCOL IS LIMITED TO MEDICAL
CARE OR IF THERE WAS
EXPERIMENTAL THERAPY AND THOSE
SORTS OF THINGS AND I LOOK FOR
VERY FORWARD TO HEARING OUR
PRESENTER DISCUSS THESE THINGS.
>>THIS IS A HARD CASE SO IT'S
GOING TO BE HARD TO TOUCH
EVERYTHING SO I'M LOOKING
FORWARD TO THE QUESTION SECTION.
ALSO THERE ARE BROAD QUESTIONS
BEING ASKED AND CASE SPECIFICS
THAT ARE NOT ALWAYS DIRECTLY
ALIGNED WITH THE QUESTIONS,
BEFORE I START THOUGH, A COUPLE
WORDS ABOUT ME, I'VE ACTUALLY
GIVEN CLINICAL CENTER BIOETHICS
GRAND ROUNDS BEFORE BUT I DOUBT
MANY OF YOU WERE IN THE AUDIENCE
BECAUSE IT WAS IN 2003 AND AT
THAT TIME I WAS WEARING THE HAT
OF CLINICAL CENTER CIO AND WE
HAD JUST PUT IN THE CRIS SYSTEM
AND THE TITLE WAS WHO OWNS THE
DATA?
AND I GAVE ANOTHER TALK THAT
YEAR TALKING ABOUT INFORMATION
FOR CLINICAL RESEARCH.
SO MY CAREER HAS SPANNED
MULTIPLE DOMAINS, I USED TO
THINK WE ARE QUITE DIFFERENT BUT
I'M REALLYING NOW THAT THEY ALL
SEEM LIKE DIFFERENT ASPECTS OF
THE SAME THING.
I'VE GONE FROM HEMEATOLOGY TO
INFORMATICS IT TO BIOETHICS, AND
PARTICULARLY ALL THESE THINGS
CONVERGING NOW, NOT DIRECTLY TO
THIS CASE BUT IN THINGS LIKE BIG
DATA ASK LEARNING AND PRIVACY
AND SO, IT'S ACTUALLY AN
INTERESTING TIME TO BE BACK.
I WILL ALWAYS NOTE THAT MY
WORKING BIOETHICS AS IT IS COMES
FROM THE IRB WORLD.
SO, I APPROACH BIOETHICS AS A
SET OF PRACTICAL PROBLEMS AND
BIOETHICS PRINCIPLES AND
REGULATIONS, FRAMEWORKS FOR HOW
TO ANSWER THEM.
I THINK BIOETHICS ITSELF RARELY
GIVES ANSWERS.
IT REALLY INSTEAD GIVES YOU A
FRAMEWORK FOR HOW TO THINK ABOUT
THINGS, AND YET, JUST AS IN THIS
CASE, WHEN YOU'RE SITTING ON AN
IRB OR TAKING CARE OF PATIENTS
AT THE CLINICAL CENTER, YOU NEED
TO ANSWER QUESTIONS IN THE
MOMENT I'LL LASTLY NOTE BECAUSE
THIS IS RELEVANT TO SOME OF THE
THINGS I WILL TOUCH ON, I DON'T
THINK IT'S UNIQUE TO ME.
I HAVE A GENERAL PESSIMISM OF
THE DIRECTION OF THINGS IN THE
WORLD AT THIS MOMENT, BUT I
THINK IT'S CRITICAL THAT THAT
NOT LEAD TO REZONING 8 HOURS
NATION OR THAT IT'S NOT WORTH
CALLING OUT ETHICAL ISSUES.
THERE WILL BE SEVERAL THINGS
THAT I TOUCH ON THAT I FEEL ARE
OUTSIDE OUR ABILITY TO CONTROL
OR TO AFFECT BUT THAT DOESN'T
MEAN THEY SHOULDN'T BE CALLED
THAT.
WITH THAT HAVING BEEN SAID, LET
ME TURN TO MY SLIDES.
I WILL NOTE I HAVE NO CONFLICT
OF INTEREST FOR ANY OF THE
TOPICS IN TODAY'S SESSION EMPLOY
AND NOW I WILL JUMP INTO THE
QUESTIONS, I WILL NOTE THAT THE
QUESTIONS, SO I HAVE STRUCTURED
MY DISCUSSION AROUND QUESTIONS
THAT WERE ON A SLIGHTLY EARLIER
VERSION OF DR. LANG'S SLIDES.
SO THEY'RE NOT EXACTLY THE SAME
WORDING BUT I THINK THEY CAPTURE
THE SAME POINTS.
SO THE FIRST QUESTION IS A BROAD
1, HOW SHOULD CLINICAL CARE BE
PROVIDED TO INDIVIDUALS WHO HAVE
BEEN ARRESTED?
AND I'LL NOTE RIGHT NOW, IT'S IN
THE BACKGROUND OF ALL OF THIS,
THEY'RE PRACTICAL AND ETHICAL
ISSUES HERE AND I'M GOING TO
TALK ABOUT THE ETHICAL ISSUES.
THERE ARE CLEARLY PRACTICAL
ISSUES AS TO HOW YOU DELIVER
CARE AND HOW YOU DIRECT THE
POLICE IN THE CONTEXT OF ARREST
THAT HAVE TO BE CONSIDERED AND
PERHAPS THE DOMINANT IMPACT ON
WHAT HAPPENS BUT I'M GOING TO
TRY TO ADDRESS THE UNDERLYING
ISSUES.
SO THE QUESTION IS: HOW SHOULD
CLINICAL CARE BE PROVIDED TO
INDIVIDUAL WHO IS HAVE BEEN
ARRESTED?
SO INDIVIDUALS IN CUSTODY
WHETHER THEY'RE UNDER ARREST OR
IN PRISON, THE ISSUE IS THEY
HAVE THEIR FREEDOMS LIMITED AND
THEY MUST PROVIDE ON US TO
INCLUDE THEIR HEALTHCARE AND IN
SOME SITUATIONS PROVIDE HEALTH
GUIDANCE FOR THEM.
THERE'S NOTHING IN THE CODE OR
AMA ETHICS THAT SUPPORTS A
PHYSICIAN'S DUTIES BASED ON THE
FACT THAT AN INDIVIDUAL WHO IS
SUFFERING NEEDS.
SO THESE OBSERVATIONS SUGGEST TO
ME THAT BOTH SOCIETY AND DOCTORS
HAVE A DUTY TO PROVIDE
CLINICALLY NEEDED CARE, THE
QUESTION ASKS HOW SUCH CARE CAN
BE PROVIDED AND I THINK
ANSWERING THIS QUESTION FROM THE
PERSPECTIVE OF THE CLINICAL
CENTER REQUIRES US TO ASK
WHETHER HE COULD HAVE RECEIVED
APPROPRIATE CARE OUTSIDE OF THE
CLINICAL CENTER.
AFTERALL HE WAS ADMITTED TO
ANOTHER HOSPITAL, DIAGNOSED AND
LATER TRANSFERRED TO THE
CLINICAL CENTER FOR TREATMENT
AFTER HIS WORSENING MALIGNANCY
WAS DIAGNOSED.
IF SOCIETY AND PHYSICIANS HAVE A
DUTY TO PROVIDE CARE, WHY DIDN'T
HE RECEIVE CARE AT THE HOSPITAL
WHERE HE WAS FIRST ADMITTED.
HAD HE RECEIVED SUCH CARE, WE
WOULDN'T BE TALKING ABOUT THIS
TODAY, HE LIKELY WOULD NOT HAVE
BEEN ARRESTED AND HIS PERCEPTION
HE HAD BEEN TRAPPED BY HIS NIH
DOCTORS WOULD BE MOOT.
AND I THINK THIS IS 1 OF THOSE
AREAS THAT WE WILL NOT CHANGE
TODAY BUT IT FORCES US TO LOOK
AT DEEP PROBLEMS WITH OUR
HEALTHCARE SYSTEM.
I SUSPECT THAT HIS TRANSFER WAS
NOT TO PROVIDE CARE THAT HE
COULD ONLY RECEIVE AT NIH.
IN FABLGHT EXPLICITLY THE
PROTOCOL HE WAS ON ONLY PROVIDED
STANDARD CARE, CLEARLY INDICATED
HE NEEDED TREATMENT.
I THINK IT HAS TO DO WITH OUR
SAFETY NET AND IF WE HAD A
EQUITABLE HEALTHCARE RESEARCH,
WE WOULDN'T BE DISCUSSING THIS
CASE TODAY.
SO THE NEXT QUESTION WAS BEING
IN POLICE CUSTODY WHAT
INFORMATION SHOULD BE PROVIDED?
I DON'T KNOW IF THIS CAME UP IN
THE CASE AT HAND AND MAYBE IT
DID BUT IT'S NOT IN THE CASE
DESCRIPTION AND I THINK MY
EARLIER COMMENTS ABOUT OUR
EARLIER OBLIGATION AS PHYSICIANS
APPLY, THERE IS 1 AREA WHERE
THIS HAS BEEN ADDRESSED IN
THE--BY THE AMA CODE OF ETHICS
WHICH IS COURT DIRECTED
THERAPIES, COURT-DIRECTED
INTERVENTIONS.
AND I REPRODUCED WHAT
THOSE--WHAT THE AMA CODE OF
ETHICS ACTUALLY SAYS AND IT
BASICALLY REITERATES THAT OUR
DUTIES ARE TOO OUR PATIENTS AND
NOT NECESSARILY TO A COURT
SYSTEM WHICH MAY HAVE SOCIALLY
IMPORTANT INTERESTS BUT THEY'RE
NOT NECESSARILY THE SAME
INTERESTS AS THE HEALTHCARE
SYSTEM AND SO, YOU KNOW SO WE
ONLY SHOULD PROVIDE THERAPY
THAT'S EFFICACIOUS AND CAN'T BE
CONTRUED AS PART OF AN
INDIVIDUAL'S PUNISHMENT,
TREATMENT BY WHAT WE DIAGNOSE AS
PHYSICIANS AND NOT WHAT THE
COURTS SAY, DECLINE TO PROVIDE
TREATMENT THAT'S NOT
SCIENTIFICALLY VALIDATED AND AS
BESTED WE CAN GIIVE THE
SITUATION, MAKE SURE THE
INDIVIDUAL HAS GIIVE CONSENT.
AND I THINK A LOT OF THESE
THINGS IN THE INDIVIDUAL CASE
WILL BE FACT DEPENDENT.
I THINK THAT--I'M SORRY, I'M
GETTING AHEAD OF MYSELF, I
APOLOGIZE FOR THE DELAY.
THERE ARE CIRCUMSTANCES THAT YOU
HAVE TO MAKE RULES BEEN WHERE
INDIVIDUALS INCARCERATION OR
ARREST MAY AFFECT DECISION
MAKING EITHER BY LIMITING IT OR
MAKING SOME CHOICES MORE
ATTRACTIVE THAN OTHERS.
FOR EXAMPLE, IF AN INVASIVE
PROCEDURE, MAY BE IN EQUIPOISE
WITH A NONINVASIVE APPROACH, BUT
THE INVASIVE PROCEDURE WOULD
LEAD TO A DELAY AND
INCARCERATION, YOU KNOW THOSE
ARE THINGS THAT WE WOULD HAVE TO
CONSIDER ON A CASE BY CASE BASIS
OR IF THE THOUGHT OF
INCARCERATION CHANGED SOMEONE'S
MENTAL STATE SO THEY'RE
SUICIDAL, WE WOULD REALLY HAVE
TO-LIFE BUT IT'S IMPOSSIBLE TO
MAKE RULES ABOUT THOSE THINGS.
SO THE NEXT QUESTION, DOES BEING
IN POLICE ON A RESEARCH
PROTOCOL?
WE HAVE TO LEAD WITH THE
QUESTION, AS A PRACTICAL ISSUE,
NOT AS A BIOETHICS DECISION, CAN
WE MAKE THIS DECISION LATE, SO
SOMEONE WITH ARREST IS KIND OF
IN LIMBO, THEY HAVEN'T BEEN
CONVICTED OF A CRIME, NOT IN
PRISON BUT THEIR FREEDOMS ARE
CONTRAINT STRAINED AND IT WILL
RESOLVE 1 WAY OR THE OTHER.
OBVIOUSLY IF THEY'RE RELEASED
THEN ALL THESE ISSUES ARE
RESOLVED AND IF THEY'RE
IMPRISONED THEN ANOTHER SET OF
ISSUE SYSTEM CREATED BUT AT
LEAST YOU SORT OF KNOW THE
CONTEXT.
SO IF YOU CAPTAIN DELAY IT THE
ANSWER IS AGAIN, INDIVIDUALS
RECEIVING ACCESS TO CARE, AND
CARE OUTSIDE THE STUDY THEN IT'S
OUR DUTY AS PHYSICIANS TO
PROVIDE THAT CARE.
IF AN INDIVIDUAL IS FREE TO
CONSENT, AND REMOVING THEM FROM
PARTICIPATION WOULD COMPROMISE
THE SCIENTIFIC INTEGRITY OR
VALUE OF THE STUDY AND I WILL
COME BACK TO THAT ISSUE, THEN I
THINK AS RESEARCHERS IN OUR DUTY
AS RESEARCHERS IT'S ALL
APPROPRIATE TO CONSIDER KEEPING
THEM ON THE PROTOCOL.
AND I THINK I PUT THIS--I PUT
THIS BALANCE HERE BECAUSE FOR
THE REASON THAT WE OFTEN LOOK AT
THE RESEARCH REGULATIONS AND
LOOK AT THE HARMS TO SOME THINGS
OR THE BENEFITS THAT WE WILL
RECEIVE DIRECTLY FROM
PARTICIPATION AND WE PUT THAT ON
1 SIDE OF THE SCALE AND IN THE
CASE OF ARREST OR IMPRISONMENT,
THE OTHER SIDE OF THE SCALE IS
THE RESTRICTED AUTONOMY.
WE ALL CONSIDER THE PERSONAL
RISKS AND BENEFITS ON THE
BALANCE SAID BUT WE WOULD ONLY
ALLOW COMPROMISED AUTONOMY.
IF IN THIS CASE--IF NOT
ACCEPTING THAT WOULD LEAD TO
HARMINGS OR DENIAL OF NEEDED
CARE, I THINK A CASE CAN BE MADE
AND I'M NOT SURE IT APPLIES IN
THIS CASE, BUT IMAGINE A RARE
DISEASE PROTOCOL WHERE THE DATA
IS VERY VALUABLE, RESEARCH IS A
SOCIAL ENTERPRISE AND A SOCIAL
GOOD.
IT'S NOT THAT IT SHOULD BE AN
EASY DECISION, OR THAT IT SHOULD
ALWAYS APPLY, BUT THE SCIENTIFIC
MANDATE HAD WEIGHT ON THAT SCALE
AS WELL.
SO IS IT APPROPRIATE FOR
PRISONERS TO APPLY TO A PERSON
WHO IS UNDER ARREST?
YES PROTECTIONS ARE CLEAR BUT TO
AMRI TO INDIVIDUALS AWAITING
AREIGNMENT, COURT TRIALS.
REACTION TO EXPLOITATION, TO
SYSTEMATIC EXPLOITATION.
IT'S WORTH ASKING IF DENIAL IN
ONGOING RESEARCH WITH DIRECT
BENEFITS IN THE SETTING OF
ONGOING CONSENT IS REALLY
CONSISTENT WITH THE INTENT OF
THE REGULATIONS.
IS IT PROTECTION IN THAT CASE OR
IS IT A LIMITATION OF ACCESS?
AND THIS QUESTION IS BEING ASKED
ABOUT THE REGULATIONS AND THE
CONTEXT OF OTHER VULNERABLE
POPULATIONS.
THE QUESTION IS, IS THE WORDING
AND CURRENT INTERPRETATIONS OF
THE REGULATIONS HAS IT TO DATE
LED TO INHERENT INIQUITIES AND
INJUSTICES IN THE SOCIAL PROJECT
OF RESEARCH?
AS AN ASIDE, THERE'S PLENTIFUL
EVIDENCE THAT BLACK PEOPLE ARE
PLACED IN POLICE CUSTODY MUCH
MORE FREQUENTLY THAN WHITE
PEOPLE IS A STRICT READING OF
THE REGULATORY LANGUAGE, DOES
THAT LEAD TO EQUITIES AND ACCESS
TO THESE, OR TO THE BENEFITS OF
RESEARCHY AND I THINK THIS IS A
TIME WHEN WE'RE REEXAMINING THAT
IN MANY CONTEXTS.
LASTLY AND WHILE THE REGULATIONS
APPLY, THEY WERE WRITTEN TO
ADDRESS PLANNED RESEARCH ON
PRISONERS AS A POPULATION AND
DON'T REALLY ADEQUATELY ADDRESS
EITHER, 1 THE RIGHT APPROACH IN
THE CASE WHERE AN INDIVIDUAL'S
INCARCERATED DURING A RESEARCH
PROTOCOL OR 2 THE RIGHT APPROACH
TO INDIVIDUALS WHO ARE IN THIS
LIMBO BETWEEN ARREST AND
CONVICTION.
IT'S MEANT TO COVER THEM SO THEY
RECEIVE PROTECTIONS BUT IT
DOESN'T PROICIDE US MUCH
GUIDANCE AS TO WHAT TO DO IN
THESE SITUATIONS.
DOES IT MATTER
WHETHER THE PROTOCOL IS LIMITED
PROVIDING STANDARD MEDICAL CARE?
>>SO FIRST OF ALL JUST
CLARIFICATIONS HERE THAT
PROTOCOL IS DOING MUCH MORE THAN
PROVIDING STAN ARD MEDICAL CARE,
IT'S CLICKING DATA AND
BIOSPECIMENS, IT'S PROVIDING
TRAINING, SO, I THINK WE NEED TO
BE PRECISE IN OUR LANGUAGE.
IT'S REALLY THE CARE PROVIDED BY
THE PROTOCOL IS LIMITED TO
STANDARD MEDICAL CARE BUT WE
HAVE TO ACKNOWLEDGE THE PROTOCOL
HAS VALUE BEYOND THAT.
IF NOT, YOU KNOW THE CLINICAL
CENTER WOULD NOT BE ALLOWED, THE
CLINICAL CENTER CAN'T SIMPLY BE
A PROVIDER OF HEALTHCARE.
THAT BEING SAID, YOU KNOW THERE
ARE JUST 2 SEPARATE AND LEGALLY
ORTHOGONAL SETS OF CONCERNS HERE
AND THERE ARE 2 SOCIAL PROJECTS.
THERE'S THE PROJECT THAT
FEDERALLY FUNDED SCIENCE FOR THE
GOOD, THAT'S WHAT NIH IS ABOUT,
AND THERE'S THE PROJECT OF
CRIMINAL JUSTICE AND THE
CRIMINAL JUSTICE SYSTEM WHICH
SERVES AN ENTIRELY DIFFERENT
SOCIAL JUSTICE PURPOSE.
MOST OF THE TIME THOSE ARE
SEPARATE WHICH IS WHY WE HAVE TO
TALK ABOUT CASES LIKE THIS AND
WHERE WE ANTICIPATE THEIR
INTERSECTION AND REGULATIONS IN
SUBPART C ARE SUPPOSED TO GUIDE
US IN HOW TO BALANCE THESE 2
INDIVIDUALLY MERITORIOUS
PROJECTS.
THAT PROVIDES THE CONTEXT.
THE OTHER THING THAT I THINK IS
VERY RELEVANT IS THIS WHOLE
QUESTION, ONCE WE REMEMBER THAT
THE PROTOCOL IS DOING MUCH MORE
THAN PROVIDING CARE, IT'S
COLLECTING DATA AND CONTRIBUTING
TO SCIENTIFIC KNOWLEDGE AND
ADVANCING THE PUBLIC GOOD IN
THAT WAY.
WE CAN LEAVE BEHIND FOR A MOMENT
THIS IDEA THAT'S PERVASIVE THAT
THE ONLY THING A PROTOCOL IS
DOING OR COLLECTING FROM A
PERSON IS SORT OF THESE
INTERVENTIONS.
YOU KNOW WE'RE FACING A TIME
WHEN THE VALUE OF DATA IS BEING
MADE VERY EXPLICIT.
IN OUR COMMERCIAL SECTOR IT'S
QUITE CLEAR THE DATA IS VERY
HIGHLY VALUED.
THAT'S SOMETHING THAT RESEARCH
PARTICIPANTS ARE GIVING US FROM
THEIR PARTICIPATION.
AND AGAIN, IF WE STOP--AND DATA
COLLECTION CAN ALSO HAVE HARMS.
AND IF YOU'RE UNFAMILIAR WITH
THAT, ALTHOUGH I THINK EVERYBODY
IS NOW, I WOULD RECOMMEND THE
FEDERAL TRADE COMMISSION JUST
RELEASED AN AMPRN AN
ANNOUNCEMENT OF POTENTERAL
RESPECTIVE RULE MAKING ABOUT
PRIVACY PROTECTIONS IN BIG DATA
IF YOU WILL, UBIQUITOUS DATA
COLLECTION WHICH DISCUSSES A LOT
OF HARMS THAT COME FROM THIS.
SO I THINK WE HAVE TO GET AWAY
FROM THE IDEA THAT THE ONLY
THINGS WE CONSIDER IN CASES LIKE
THIS ARE THE DIRECT BENEFIT OR
RISK THAT SOMEONE'S UNDERTAKING
AND THAT TAKES US BACK TO THIS
BALANCE WE HAVE TO FIND IN
ANSWERING THE QUESTION HOW DO WE
BALANCE, CONTINUED PARTICIPATION
IF IT COMES IN THE FACE OF
RESTRICTED AUTONOMY.
SO I DON'T THINK THAT IT WILL
MATTER IN THAT BALANCE WHETHER
THE PROTOCOL IS LIMITED TO
PROVIDING MEDICAL CARE BUT WE
STILL HAVE TO CONSIDER THAT
BALANCE.
THERE ISN'T 1 ANSWER FOR ALL
CIRCUMSTANCES.
NOW THERE WERE 2 OTHER THINGS
THAT THIS ISSUE, THIS CASE
RAISED FOR ME.
THAT WEREN'T IN THE QUESTIONS
BUT I THINK BEARS MENTIONING, 1
IS THE OBLIGATION OF RESEARCH
PARTICIPANTS.
AT LEAST 1 CHARGE AGAINST DL WAS
RELATED TO ALLEGED THEFT AT NIH
AND WHILE I HAVEN'T READ THE
PROTOCOL, MOST PROT COLS ALLOW
THE PRINCIPAL INVESTIGATOR TO
TERMINATE A SUBJECT'S
PARTICIPATION FOR A VARIETY OF
REASONS AND IT'S CERTAINLY
POSSIBLE HAD THE PI KNOWN OF THE
THEFT, THE DL WOULD HAVE BEEN
DROPPED FROM THE PROTOCOL BEFORE
THESE EVENTS OCCURRED AND WHILE
WE OFTEN TALK OF WHAT WE AS
RESEARCHERS OWE OUR RESEARCH
SUBJECTS, THERE ARE OBLIGATIONS
SUBJECTS TAKE ON AND NOT
FULFILLING THOSE OBLIGATIONS CAN
HAVE CONSEQUENCES FOR THE
PRACTICAL CONDUCT OF THE
RESEARCH AND FOR THE INTEGRITY
OF THE SCIENCE THAT RESULTS AND
THE VALUE OF THAT SIZE.
THE OTHER CONCERN IS THE ROLE OF
THE NIH POLICE.
YOU KNOW I WORKED AT NIEKS H FOR
MORE THAN A DECADE BEFORE 9/11
AND WE THOUGHT OF OURSELVES AS
SCIENTISTS AND DOCTORS ALBEIT
GOVERNMENT SCIENTISTS AND
DOCTORS AND THE ROLE OF OUR
INSTITUTION WAS TO CONDUCT
RESEARCH TO IMPROVE THE HEALTH
OF ALL.
THE ROADS ON TO CAMPUS AND THE
DOORS TO THE CLINICAL CENTER
WERE OPEN, AND THE NIH POLICE
WERE THERE TO PROTECT FEDERAL
PROPERTY AND FEDERAL EMPLOYEES.
THINGS HAVE CHANGED AND FOR VERY
JUSTIFIABLE REASONS BUT FOR THE
CLINICAL CENTER TO APPEAR TO
PATIENTS AND VISITORS FIRST AS A
FEDERAL FACILITY AND ONLY SECOND
AS A RESEARCH HOSPITAL FRANKLY
SADDENS ME.
SO THIS IS MY LAST SLIDE AND
JUST TO SUMMARIZE THE QUESTIONS,
THE ISSUES, I THINK THERE'S THIS
HUGE ISSUE AND THIS COMES UP ON
THE IRB ALL THE TIME BECAUSE
PEOPLE ENROLL IN PROTOCOLS,
BECAUSE THEY CAN'T OFTEN GET
ADEQUATE CARE ELSEWHERE, SO HOW
DO YOU CONDUCT ETHICAL RESEARCH
WHETHER IT INVOLVES STANDARD
CARE OR NOT IN THE CONTEXT OF A
HEALTHCARE DELIVERY SYSTEM THAT
IS INEQUITABLE AND UNJUST?
I THINK THE SECOND ISSUE IS
REGULATIONS THAT WERE WRITTEN
SOME YEARS AGO NOW TO
APPROPRIATELY ADDRESS ELGTICAL
TRESPASSES AND WHICH CAN NOW,
YOU KNOW--BUT ARE FAIRLY NARROW.
AND SO, DON'T REALLY APPLY WELL
TO SOME OF THE THINGS WE'RE
SEEING TODAY AND IN THIS CASE,
WE HAVE A SET OF REGULATIONS
THAT MEANT TO PROTECT PRISONERS
FROM EXPLOITATION BUT WE HAVE AN
INDIVIDUAL WHO WILL SUFFER IF
NOT CONTINUED ON THEIR RESEARCH
PROTOCOL AND WE HAVE SCIENCE
THAT WILL SUFFER AND WE HAVE TO
ASK, IS THAT REALLY WHAT WAS
BEHIND THE REGULATIONS OR DO WE
NEED SOME ADDITIONAL
INTERPRETATION.
I THINK THE THIRD THING IS
SCIENCE IS A PUBLIC GOOD.
AGAIN, WE ALWAYS--THE RESEARCH
REGULATIONS AND OUR ETHICAL
FRAMEWORKS ARE FOCUSED ON HARMS
TO THE PARTICIPANTS BECAUSE OF
THE HISTORY OF THOSE REGULATIONS
AND HOW THOSE ISSUES AROSE.
BUT SCIENCE ITSELF, THAT THE
JUSTIFICATION FOR FUNDING THE
NIH AND FOR THE NIH'S MISSION IS
THAT SCIENCE IS AN IMPORTANT
PUBLIC GOOD AND I THINK THAT HAS
TO BE PART OF THE BALANCE WHEN
WE MAKE THESE DECISIONS.
THE NEXT 1 IS SOMETHING THAT I
THINK IS FAMILIAR TO PROBABLY
EVERYBODY WHO'S LISTENING AND
THAT IS THAT OUR ROLE, OUR ROLES
ARE OFTEN AND OUR DUTIES, OUR
ETHICAL DUTIES ARE OFTEN
CONFLINTHED AND FINDING A
BALANCE BETWEEN THEM IS NOT
ALWAYS STRAIGHT FORWARD.
IN CLINICAL RESEARCH, THERE'S
ALWAYS A TENSION BETWEEN ACTING
AS AN INVESTIGATOR AND ACTING AS
A DOCTOR.
AND I THINK THE CLINICAL CENTER,
DOCTORS AND PROVIDERS AT THE
CLINICAL CENTER HAVE AN
ADDITIONAL FRAMEWORK, THAT OF
THE FEDERAL EMPLOYEES WITH--WHO
ARE ACCOUNTABLE TO TAXPAYERS AND
SOCIETY IN THAT ROLE, THAT MAY
ALSO BE INTENTIONED IN SOME
CASES AND THE LAST THING IS, YOU
KNOW JUST TO MY LAST POINT TO
THE PREVIOUS SLIDE, DOES THE
CLINICAL CENTER WANT TO BE SEEN
AS A FEDERAL FACILITY THAT IS A
RESEARCH HOSPITAL OR AS A
RESEARCH HOSPITAL THAT HAPPENS
TO BE A FEDERAL FACILITY AND I
SUSPECT THAT MOST OF THE PEOPLE
WHO ARE LISTENING WOULD, WELL, I
HOPE WOULD LIKE TO SEE A ROLE AS
THAT OF A RESEARCH HOSPITAL
FIRST.
I'M GOING TO TRY TO TURN ON MY
CAMERA NOW, FOR THE QUESTIONS.
>>THANK YOU THAT WAS GREAT.
JUST A COUPLE, 2 QUICK REMINDERS
BEFORE WE GET STARTED HERE.
FIRST A REMINDER FOR PEOPLE WHO
CHECKED IN LATE, THERE IS CME
CREDIT FOR THIS SESSION THROUGH
JOHNS HOPKINS TO GET THAT CME
CREDIT YOU NEED TO TEXT THE
FOLLOWING CODE TO THE HOPKINS
CME NUMBER THAT'S ON THE INITIAL
SLIDE AND THAT WILL COME UP
AGAIN AT THE END OF THE SESSION,
IF YOU DIDN'T GET TO SEE IT AND
THAT CODE FOR TODAY'S SESSION IS
44524.
SO 44524.
THAT'S TO CLAIM CME CREDIT.
THE SECOND THING IS WE WELCOME
PEOPLE'S TIME FOR QUESTIONS, WE
HAVE TIME FOR QUESTION ANDS TO
ASK QUESTIONS YOU GO TO THE LIVE
FEEDBACK BUTTON AT THE BOTTOM OF
THE SCREEN ON THE NIH VIDEOCAST
WEBSITE, AND THOSE QUESTIONS
WILL BE DIRECTED TO ME AND I'LL
ASK THEM OF STEPHEN AS WE HAVE
TIME.
SO IF PEOPLE HAVE QUESTIONS
PLEASE PUT THEM IN AND I'LL ASK
THEM AS WE GO.
SO I WANTED TO START JUST BY
MAKING SURE--I THINK THIS IS
RIGHT JUST TO CLARIFY AND
REINFORCE THIS.
IT SOUNDS LIKE YOUR VIEW AND
JUST BY THE REGULATION, SO
SOMEBODY WHO'S IN POLICE CUSTODY
IS COUNTED AS A PRISONER FOR THE
PURPOSE OF THE PRISONER
REGULATIONS AND MORE OVER THAT'S
TRUE EVEN IF THEY ENROLLED IN
THE STUDY AND BEGAN
PARTICIPATING IN THE STUDY
BEFORE THEY BECAME ARRESTED.
AND SO SOMEBODY WHO STARTS IN A
TRIAL, GIVES CONSENT WITHOUT ANY
CONCERNS ABOUT ARREST OR
COERCION IS PARTICIPATING IN THE
STUDY FOR A WHILE, THEN GETS
ARRESTED, THAT PERSON EVEN
THOUGH THEY'RE NOT IN PRISON
YET, THEY'RE ALREADY AT HOME,
THAT PERSON COUNTS AS A PRISONER
ACCORDING TO THE REGS AND
THEREFORE COULDN'T CONTINUE TO
PARTICIPATE WITHOUT THE IRB
GOING THROUGH ALL OF THE
PRISONER RANKS WITH RESPECT TO
THE PROTOCOLS, DOES THAT SOUND
RIGHT?
>>I THINK THAT IS RIGHT.
SO ON IRBs WE OFTEN SEE THIS,
PEOPLE END UP IN PRISON OR
ARRESTED, YOU KNOW IT HAPPENS
AND I THINK THAT'S A FREQUENT
THING AND IT OFTEN COMES BACK TO
AN IRB THAT DOESN'T HAVE A
PRISONER REPRESENTED AND THEN
USUALLY THE QUESTION IS, WILL
THIS CONTINUATION HARM THAT
INDIVIDUAL?
DO THEY NEED SOMETHING THAT THEY
CAN ONLY GET THROUGH THE
RESEARCH?
AND IF THEY DO, THE IRB REALLY
HAS TO SAY, YOU KNOW YOU
CAN'T--SO, I SUSPECT EVERY IRB
DOES THIS DIFFERENTLY BUT I
THINK IT WOULD BE ETHICALLY
INCORRECT OR WRONG TO DENY
SOMEONE ACCESS TO A PROTOCOL IN
WHICH THEY ALREADY STARTED IN
WHICH THEY GAVE CONSENT TO AND
WE WERE DENYING THEM WOULD HARM
THEM BECAUSE THE REGULATIONS SAY
YOU NEED A PRISONER
[INDISCERNIBLE].
THERE ARE LOTS OF WAYS YOU COULD
APPROACH THAT, GET A PRISONER
REP AREY SENTED AS A CONSULTANT,
YOU COULD DO LOTS OF THINGS BUT
DENYING SOMEONE THAT ACCESS
BECAUSE OF THE LIMINGITTATIONS
OF YOUR IRB WOULD NOT BE PROPER.
THERE'S ANOTHER PIECE TO THAT,
WHICH WAS IN DR. LANG'S
OIGEINAL--WAS IN THE SLIDES AND
THAT I DIDN'T ANSWER WHICH IS
DOES IT MATTER IF THEY WERE ON
THE PROTOCOL BEFORE OR NOT AND I
THINK IT DOES MATTER.
SO THE REGULATIONS WERE REALLY
TO PROTECT PEOPLE FROM
PROSPECTIVE INVOLVEMENT IN
RESEARCH, PRISONERS AS A
POPULATION.
AND I THINK IF PEOPLE AREN'T--I
DON'T CPS AS RESEARCHERS WE CAN
SAY, SOMEONE SHOULD GET THIS
INTERVENTION THAT WE'RE TESTING
BECAUSE IT'S NECESSARY.
THERE ARE LOTS OF STUDIES THAT
GO ON, FOR INCURABLE CONDITIONS
OR CANCERS WHERE WE KNOW THE
OUTCOMES ARE POOR AND WE'RE
DOING RESEARCH ON ALTERNATIVES,
THAT'S TYPICALLY NOT SUFFICIENT
TO JUSTIFY ENROLLING PRISONERS
AS A POPULATION.
I THINK IT'S DIFFERENT.
IF SOMEONE'S ENROLLED ALREADY,
THEN IT COMES DOWN TO THEIR
SPECIFIC CASE AND AS I NOTED
THAT'S NOT SOMETHING THAT THE
REGULATIONS DREATIONZ
PARTICULARLY WELL.
THAT'S NOT WHAT THEY WERE
DESIGNED TO DO, THEY WERE
DESIGNED TO STOP PEOPLE FROM
BEING COERCED INTO PARTICIPATE
NOTHING RESEARCH.
>>GREAT.
I WAS STRUCK--I WASN'T AWARE OF
THE AMA GUIDANCE ON THIS BUT I
WAS STRUCK, I WILL TRY TO TIE
THESE 2 TOGETHER IN A SECOND,
BUT I WAS STRUCK BY WHAT IT SAID
IN PART WAS THAT WHILE
CLINICIANS, PHYSICIANS, I GUESS
HAVE AN OBLIGATION TO PROVIDE
CARE, EVEN TO PRISONERS, THAT
THEY SHOULD DECLINE.
I TRIED TO WRITE DOWN THE QUOTE
THEY SHOULD DECLINE TO PROVIDE
TREATMENT THAT HAS NOT BEEN
VALIDATED.
AND I WAS STRUCK BY THAT BECAUSE
THAT SOUNDS--MAYBE THAT'S JUST
WITHIN THE KIND OF SCOPE HERE, I
WAS WONDERING IF THAT RAISES
CONCERNS THEN ABOUT CLINICIANS
BEING INVOLVED IN RESEARCH
TRIALS WHERE YOU'RE TESTING SOME
EXPERIMENTAL INTERVENTION.
>>SO THAT'S NOT--TO MY READING
THAT'S NOT THE INTENDED OF THAT
OPINION, THAT OPINION IS TO
ADDRESS CIRCUMSTANCES WHERE THE
COURT DIRECTS THERAPY, THAT THE
INDIVIDUAL WOULDN'T NECESSARILY
WANT AND I THINK THAT GETS BACK
TO THE BALANCE OF THOSE 2
ISSUES.
COURTS MAY DO ALL SORTS OF
THINGS AND THERE'S LANGUAGE, I
WILL READ IT TO YOU FROM THE
THING ABOUT THE--YEAH, SO, IT'S
NOT EITHER A FORM OF PUNISHMENT
OR A MECHANISM OF SOCIAL
CONTROL.
SO WE AS DOCTORS SHOULD ONLY BE
APPLYING MEDICAL THINGS AND WE
SHOULDN'T BE USING AGENTS TO THE
CRIMINAL JUSTICE SYSTEM.
AND THERE'S A BODY OF LEGAL
PRECEDENT UP TO THE SUPREME
COURT WHICH LOOKS AT WHETHER
DENIAL OF HEALTHCARE AND THIS IS
NOT RESEARCH, BUT DENIAL OF
HEALTHCARE ACTUALLY IS
PROHIBITED BY THE EIGHTH
AMENDMENT AGAINST CRUEL AND
UNUSUAL PUNISHMENT AND SO IN
SOME CIRCUMSTANCES, IT
IS--THAT'S WHAT THE SUPREME
COURT CONCLUDED ALTHOUGH THERE'S
A FAIRLY HIGH BAR FOR SUGGESTING
THAT THAT'S ACTUALLY WHAT'S
GOING ON BUT, YEAH, SO, I THINK
THIS WAS--I THINK I ANSWERED THE
QUESTION, I HOPE.
BUT, YEAH.
THAT WASN'T THE INTENT OF THE
[INDISCERNIBLE].
>>DO YOU THINK--I WANT TO TIE
THOSE TOGETHER JUST QUICKLY, I
REALLY LIKE YOUR CALL AT THE
BEGINNING OF THERE'S ISSUES
CHALLENGES AND MAYBE WE'RE NOT
GOING TO FIX ALL OF THEM OR MANY
OF THEM BUT WE SHOULD AT LEAST
DISCUSS THEM AND SEE WHAT WE CAN
DO AND I WAS WONDERING SURELY
WITH RESPECT TO THE CLINICAL
CARE SETTING AND MAYBE EVEN MORE
SO IN RESEARCH WHEN WE THINK
ABOUT THE PRISONER REGS, THEY'RE
FAIRLY RIGID AND THEY HAVE RULES
THAT AMRI TO EVERYBODY AND
OBVIOUSLY CAN YOU NEVER COME UP
WITH A RULE THAT WORKS IN EVERY
CASE, AND 1 OF THE THINGS I'VE
ALWAYS WONDERED IS, WELL IN SOME
CASES YOU DON'T HAVE ANY
ALTERNATIVES.
BUT IN THE RESEARCH STUDY WE DO
HAVE AN ALTERNATIVE, WE HAVE
THIS GROUP, YOU KNOW JUST ABOUT
EVERYBODY IN THE COUNTRY CALLED
IRBs AND THEIR CHALLENGE IS TO
MAKE SURE THAT THINGS ARE DONE
RIGHT.
AND SO I WAS WONDERING SHOULD
THERE BE--BECAUSE THERE'S THE
PIE IN THE SKY PART OF WHETHER
THIS WILL EVER HAPPEN BUT
WHETHER OR NOT YOU THINK IT
MAKES SENSE TO HAVE SOME KIND OF
EXCEPTIONS, QUALIFICATIONS,
FLEXIBILITY IN THE REGS THAT
SAYS BE, YOU KNOW IF A DULY
CONSITUTED IRB MAKES THE
JUDGMENT AND THE DETERMINE
NATION AND APPLIES IT AS THEY'RE
WRITTEN WILL BE SOMETHING LIKE A
SERIOUS MISTAKE IN A PARTICULAR
CASE, THEY ARE ALLOWED TO
EXERCISE SOME KIND OF EXPERIMENT
AND FLEXIBILITY, IS THAT A GREAT
IDEA?
NOW OF COURSE WE GO BACK TO THE
POINT OF THE CONFLICTS OF
INTEREST ON IRBs AND I DON'T
WANT TO TALK ABOUT, BUT I WAS
WOBDERRING WHAT YOU THOUGHT?
SHOULD YOU THINK THERE SHOULD BE
SOME KIND OF FLEXIBILITY LIKE
THAT IN THE SYSTEM OR IS THAT
NAIVE OR PROBLEMATIC?
>>SO I THINK THE WHYED IS A
GOOD 1.
WE NEED TO HAVE I CLINICAL
CENTER BIOETHICS GRAND ROUNDS ON
THE RIERKS SYSTEM.
BECAUSE--IRB SYSTEM.
BECAUSE I THINK THERE ARE LOTS
OF PROBLEMS WITH THE IRB SYSTEM
THAT MAKE THAT, I DON'T KNOW
HAVING 6 OR 10 OR 15 PEOPLE
AROUND A TABLE FROM A PARTICULAR
INSTITUTION OR PARTICULAR
COMPANY MAKING AN ETHICAL THING
THAT HAS IMPLICATIONS, WILL HAVE
IMPLICATIONS FOR OTHERS AS A
1-OFF DECISION IS NECESSARILY
APPROPRIATE.
IF WE HAD A SYSTEM WHERE IRBs
COULD CALL IT PRECEDENT ALTHOUGH
THAT'S A FRAUGHT WORD BECAUSE
PEOPLE SEE PRECEDENT AS BINDING
AND THERE ARE ALL SORTS OF
ISSUES BUT IF IRBs KDZ
COMMUNICATION RATIONALS AND
THOSE WERE PUBLIC AND THEY
SERVED AS A BUSINESS PROGRAMSIS
FOR SORT OF AN EMERGING AND
EVOLVING ETHICAL FRAMEWORK, I
THINK THERE SHOULD BE THAT
FLEXIBILITY.
I DON'T THINK THE CURRENT SYSTEM
PROVIDES IT I THINK THOSE
DECISIONS ARE MADE BEHIND CLOSED
DOORS, THEY NEVER FORM ANYTHING
ELSE, I DON'T THINK IT'S
APPROPRIATE AND I DO THINK THERE
ARE CONFLICTS OF INTEREST WHICH
WOULD RAISE QUESTIONS ABOUT THE
INTEGRITY OF THOSE DECISIONS.
SO I THINK THE IDEA OF ALLOWING
AND THE REGULATIONS ACTUALLY
DO,A LOW THIS, I MEAN I DON'T
KNOW THAT ANYONE TAKES ADVANTAGE
OF IT BUT THE REGULATIONS ALLOW
EXCEPTIONS TO BE MADE BY THE
SECRETARY.
OF HHS, SO IF THEIR PARTICULAR
CIRCUMSTANCES, YOU KNOW, WE'RE
ALL FAMILIAR WITH THOSE
PROVISIONS WITH SUBPART B IF YOU
CAN'T FIT IT INTO 1 OF THOSE
CATEGORIES, THEREYA A FORMAL
MECHANISM TO GO BEYOND THAT BUT
I THINK THAT'S A REASONABLE
MODEL IF THERE WAS A MECHANISM
TO APPEAL PARTICULAR PARTS OF
THE REGULATIONS, PARTICULARLY
NOW AS WE'RE BECOMING
INCREASINGLY AWARE OF THE
CONSEQUENCES OF STRICT
COMPLIANCE OF THE LETTER OF
REGULATIONS WHICH REALLY HAS LED
TO AN INEQUITABLE RESEARCH
SYSTEM AND INEQUITABLE
DISTRIBUTION OF BENEFITS NOT
JUST PROTECTION FROM
EXPLOITATION, BUT ACTUALLY A
SYSTEM THAT DOESN'T REPRESENT
THE SOCIETY THAT IT'S SUPPOSED
TO SERVE.
SO I THINK THERE ARE DEEPER
QUESTIONS AND A MECHANISM LIKE
THAT WOULD BE VERY WELCOME.
I DON'T THINK OUR CURRENT SYSTEM
OF IRBs PROVIDES THAT
ADEQUATELY.
I
--
>>I SHOULD SAY YOU'RE NOT
BREAKING UP AT ALL NOW, SO KEEP
YOUR CAMERA ON FOR THE Q&A.
>>OKAY.
>>SO SOMEONE'S ASKING FOR
CLARICTION, DO YOU THINK THAT
THE 1 OF THE PRIMARY PROBLEMS
HERE IS JUST A BACKGROUND
CONTEXT CONCERNING THE U.S.
HEALTHCARE SYSTEM WHERE PEOPLE
CAN'T ALWAYS GET THE CARE THEY
NEED IN THE COMMUNITY AND
THEREFORE MAYBE LIKE FOR THIS
GUY, THE ONLY WAY TO GET IT IS
TO COME INTO A RESEARCH STUDY,
IS THAT RIGHT OR IF YOU HAD ANY
QUURGT FURTHER COMMENTS ON THAT?
>>I THINK THE CASE FROM
BEGINNING TO END LONG BEFORE THE
ARREST CAME UP IS AN EXAMPLE OF
THAT ISSUE.
I THINK IT'S VERY--IT'S NOT
ONLY--IT'S NOT ONLY ACCESS TO
BASIC CARE BUT I MEAN THERE'S
LITERATURE THAT SUGGESTS THAT
CARE, YOU GET CARE AT A RESEARCH
INSTITUTION IS OF A DIFFERENT
QUALITY THAN CARE YOU GET IN A
COMMUNITY HOSPITAL AND YOU KNOW
I THINK THESE ARE--THE
UNDERLYING--THERE ARE LOTS OF
CAUSES AND THEY'RE NOT EASY
FIXES BUT I THINK THEY ARE DEEP
PROBLEMS IN THEIR HEALTHCARE
SYSTEM, THAT CERTAINLY MAKE--I
SUSPECT FOR A PATIENT LIKE DL,
THAT'S WHY THEY'RE AT THE NIH.
>>SO 2 VERY PRACTICAL
QUESTIONS.
DOES HOW WE TREAT THIS GUY
DEPEND UPON THE NATURE OF
WARRANT WITH WHICH HE WAS
ARRESTED?
SO IT WAS CHILD PAYMENT AND SOME
THEFT?
IS THAT DIFFERENT THAN IF IT HAD
BEEN HOMICIDE?
EASY QUESTIONS HERE FOR YOU?
THE SECOND 1 IS JUST A PRACTICAL
QUESTION, IS THIS A GREAT IDEA
OR JUST GOING OVERBOARD?
SHOULD THERE BE SOME KIND OF
JUST SCREENING WARNING FOR
PEOPLE?
ONE THE OF THE THINGS THAT WILL
HAPPEN WHEN YOU COME HERE IS YOU
WILL HAVE TO GO THROUGH THIS
SCREENING, AS YOU SAID NOW WE
DIDN'T USED TO HAVE THESE FENCES
AND ALL OF THIS BUT WE DO MOW
AND WE'RE--I ASSUME STUCK WITH
IT AT LEAST FOR THE FORESEEABLE
FUTURE WHEN PEOPLE COME TO THAT
GATEWAY CENTER, THIS THERE BE
SOME INFORMATION?
LOOK IF YOU WANT TO COME THROUGH
HERE, WE WILL CHECK FIRST TO
LOOK AT THE FOLLOWING THINGS IN
YOUR RECORD, AND IF THEY COME UP
THE WRONG WAY, HERE'S WHAT YOU
SHOULD DO SO YOU SHOULD KNOW
ABOUT THAT?
>>SO I WILL DEAL WITH THE
SECOND 1 FIRST.
I THINK OWE THAT TO OUR RESEARCH
PARTICIPANTS WE OFTEN TALK ABOUT
WHAT WE GET OUT OF RESEARCH, BUT
THEY'RE GIVING A LOT AND
ASSUMING RISK.
I THINK IT'S NOT JUST DURESS,
THERE ARE OTHER ISSUES LIKE
IMMIGRATION STATUS WHICH I'M
SURE IS ALSO CHECKED AND I THINK
FOR PEOPLE TO COME IN FOR
HEALTHCARE AND NOT REALIZE THAT
THOSE THINGS ARE AT RISK OR WILL
BE EXPOSED, I THINK WE SHOULD
DISCLOSE THAT AS UNCOMFORTABLE
AS THAT MAY MAKE US.
YOU KNOW, I THINK SOMEONE UNDER
ARREST--SO, TO THE FIRST PART OF
THE QUESTION, WHETHER IT MATTERS
WHETHER IT WAS HOMICIDE OR
NONPAYMENT OF CHILD SUPPORT OR
THEFT, SO IF YOU LOOK AT
PRISONER REGS, THEY DON'T MAKE A
DISTINCTION.
WOPS YOU'RE A PRISONER, YOU'RE A
PRISONER.
SO I THINK SORT OF THE FORMAL
BRAIN WORK ANALYSIS, WE WOULD
SAY, NO IT DOESN'T MAKE A
DIFFERENCE FOR THE ISSUES WE'RE
DISCUSSING.
I THINK AS A PRACTICAL MATTER,
IT WILL MAKERS AND A DIFFERENCE.
I MEAN I DON'T THINK IF IT WAS
HOMICIDE, I THINK HIS--YOU KNOW
HE WOULDN'T HAVE BEEN RELEASED
FROM POLICE CUSTODY SO FIRST OF
ALL, YOU KNOW HE'S UNDER ARREST.
HE HASN'T BEEN CONVICTED.
HE'S IN THERE GETTING TREATMENT
BECAUSE OF THE NATURE, I ASSUME
BECAUSE OF THE NATURE OF
WARRANTS, AFTER 2 DAYS THE
POLICE WERE NO LONGER SITTING
OUTSIDE HIS ROOM AND THAT
ALLOWED HIM TO LEAVE I WOULD
ASSUME IF NOTHING ELSE AN ARREST
FOR SOMETHING LIKE HOMICIDE
WOULD NOT HAVE ALLOWED THAT TO
HAPPEN BUT I DON'T THINK WE
SHOULD BE--IT'S HARD
TO--DEPENDING ON THE DETAILS OF
THE CRIME THAT'S ALLEGED, IT
WILL BE HARD NOT TO HAVE AN
IMPACT ON THE CARE TEAM AND HOW
THEY DELIVER CARE.
OT OTHER HAND IT'S NOT OUR ROLE
TO JUDGE WHETHER SOMEONE IS
GUILTY OR DRAW THOSE CONCLUSIONS
AND I THINK OUR DUTY AS DOCTORS
AND RESEARCHERS SHOULD BE TO THE
PATIENT AND THE SCIENCE.
SO AGAIN, AS A PRACTICAL MATTER,
IT WOULDN'T MATTER WOULDN'T--WT
I'M NOT SURE THAT IT SHOULD.
>>SO I CAN CLARIFY A COUPLE
THINGS, ON THE PRACTICALITY,
THERE'S NUANCES AND IT HAS TO DO
WITH IF A PATIENT WERE TO
REMARKS RIEF WITH ID OR IF THEY
DON'T HAVE ID, THEN WHERE THEY
MIGHT BE KIND OF SMOOTHED
THROUGH SO TO SPEAK, YEAH, I
KNOW THAT DR. ROSENFELD, IF
THERE'S IMMIGRATION ISSUES OR
NOT, THERE'S CERTAIN WAYS THAT
PATIENTS ARE ABLE TO GET HERE
BUT THIS IS A GREAT QUESTION
THAT WAS ASKED, A MORE GENERAL,
THAT'S NOT SOMEBODY TAKE THEM
UNDER REST BUT PEOPLE KNOW IF
YOU COME TO THIS CAMPUS, YOU'RE
NOT ALLOWED TO BRING GUNS ON THE
FEDERAL CAMPUS, EVEN IF YOU HAVE
A WARRANT.
SO IF THEY SEARCH YOUR CAR WHEN
YOU'RE COMING IN AND YOU FIND
THAT, THEN YOU'RE IN VIOLATION
OF A FEDERAL LAW AT THAT POINT
OR DRUGS, LIKE SAY MARIJUANA
WHICH MIGHT BE LEGAL FOR
NONCRIMINALLIZED ON WISCONSIN
AVENUE BUT NOT ONCE YOU CROSS
THROUGH THE GATE, THOSE SORTS OF
THINGS.
SO IT IS A GREAT POINT.
I DO THINK THAT PATIENTS ARE
PROVIDED WITH INFORMATION OF YOU
CAN BRING THIS, YOU CAN'T BRING
THAT, YOU NEED TO BRING YOUR ID,
YOU NEED TO BRING THAT.
THOSE THINGS THEN THEY BUILD UP
AND YOU HAVE THESE OTHER
CONSIDERATIONS IF YOU'RE A SICK
PERSON WHO'S COMING TO THE NIH
OR THEY MIGHT NOT REMEMBER ALL
THAT OR THE PERSON WHO DRIVES
YOU OR COMES WITH YOU, AND
YOU'VE GOTTEN SICK SO NOW A
FAMILY MEMBER WANTS TO GET HERE
AS QUICK AS POSSIBLE AND THEY
JUDGE UMP IN THEIR CAR AND THEY
HAVE SOMETHING, PLAIB THAT'S FOR
ANOTHER DAY BUT WE CAN--
>>[LAUGHTER]
>>BUT DAVID TO YOUR POINT, IF
YOU TELL PEOPLE THAT AND THEN
THEY HAVE TO MAKE A CHOICE THEIR
VISA'S EXPIRED OR SOMETHING LIKE
THAT AND NONAPOPTOTIC THE IN
THIS CASE WHERE IT'S STANDARD
CARE BUT THEY'RE EXPECTING AND
NEED THAT THERAPY.
YOU KNOW WHAT DO YOU DO THERE?
THAT'S NOT AN EASY THING.
>>THERE SOME THINGS WE ARE ABLE
TO SMOOTH IT THROUGH BUT OTHERS
WHERE IT'S NOT.
DID YOU HAVE OTHER QUESTIONS
DAVE OR?
>>YEAH, SO, THIS AN ATTEMPT TO
PUT TOGETHER, WE ONLY HAVE A
COUPLE MINUTES LEFT, I THINK I
ONLY HAVE 2 MINUTES, THIS IS
TRYING TO SMASH TOGETHER 3 OR 4
QUESTIONS, WHICH IS BASICALLY
THAT IT SEEMS LIKE AT LEAST SOME
OF THE WORRY HERE COMES WHEN
YOU'RE JUST GETTING STANDARD OF
CARE, INDICATED CARE WITHIN THE
CONTEXT OF A RESEARCH PROTOCOL
AND AS YOU WERE SAYING WHEN THEY
WERE RETIREDDEN THEY DIDN'T HAVE
THAT IN MIND, THEY HAD
EXPERIMENTAL THINGS RISKY THINGS
LEARN FROM OTHER PEOPLE,
POTENTIAL FOR EXPLOITING
SUBJECTS, THEY DIDN'T HAVE
GIVING SOMEBODY THE KIND OF CARE
THEY NEED FOR A DEEP VEIN
THOMBOSIS OR SOMETHING LIKE
THAT.
SO IS THERE 1 WAY OR ANOTHER TO
HANDLE THAT?
SHOULD IT BE THAT WE JUST DON'T
DO STANDARD OF CARE PROTOCOLS,
THAT SHOULDN'T BE WHAT THE NIH'S
IS IN THE BUSINESS TO DO OR IS
IT THAT MAYBE THE REGULATIONS
SHOULDN'T APPLY TO THOSE KINDS
OF PROTOCOLS BECAUSE YEAH,
THEY'RE UNDER THE UMBRELLA OF
RESEARCH BUT LOOK, WE'RE JUST
GIVING SOMEBODY CLINICALLY
INDICATED CARE.
IS THERE ANY ROOM ON EITHER OF
THOSE SIDES TO TRY TO HELP WITH
THIS DILEMMA.
>>I BELIEVE STRONGLY WHEN I WAS
AT NIH, SOMETHING LIKE 50% OF
THE STUDIES WERE NATURAL HISTORY
STUDIES AND I WAS IN THE
HEMEATOLOGY GROUP AND WE WERE
STUDYING THINGS LIKE
[INDISCERNIBLE] ANEMIA AND SUCH,
WHICH AT THE TIME THERE WAS NO
THERAPY FOR AND IT WAS
INCREDIBLE LOAMACYY IMPORTANT
THAT WE HAD THOSE
PEOPLE--INCREDIBLE LOAMACYY
IMPORTANT THAT WE HAD THOSE
PEOPLE COME AND WHAT WE GAVE
THEM FOR EXCHANGE FOR THEIR TIME
AND SPECIMENS AND DATA WAS WE
PROVIDED CARE AND IT WASN'T THAT
THEY COULD BT GET THE CARE
ELSEWHERE.
AND I THINK THAT PARTICULARLY IN
TODAY'S DAY, YOU KNOW ERA OF BIG
DATA AND AI AND ML, AND
INCREASING TOOL KIT TO MAKE
INFORMATION ITSELF VALUABLE AND
BIO--GENOMICS BEFORE THE HUMAN
GENOME PROJECT, THE FACT THAT WE
CAN DO WHOLE GENOME SEQUENCES
AND LOOK FOR THINGS, ALL OF THAT
IS RESEARCH OF ENORMOUS VALUE
AND I DON'T THINK THERE SHOULD
BE ANY LIMITATIONS ON THE
CLINICAL CENTER IF ARE PRACTICES
VIEDING THAT, THAT'S 1 OF THE
UNIQUE THINGS THAT NIH AND THE
CLINICAL CENTER CAN DO BECAUSE
IT'S NOT DRIVEN BY
PHARMACEUTICAL DRUG OR DEVICE
DEVELOPMENT, SO THERE'S NO MONEY
BEHIND IT SO YOU HAVE FEDERAL
FUNDS THAT FUND THIS BASIC
SCIENCE OR YOU KNOW, SO I THINK
THE ANSWER SHOULD BE NO
CONSTRAINTS ON THAT.
I THINK, YOU KNOW SO PUT ASIDE
THE PRISONER REGS, I DON'T THINK
THAT THE REST OF THE REGULATIONS
HAVE PROBLEMS WITH THAT KIND OF
RESEARCH.
AND SO, YOU KNOW THE CONSTRAINTS
ON VULNERABLE POPULATIONS I DO
THINK YOU SHOULD THINK THAT THE
IRB AND THE SCIENTISTS WRITING
THE PROTOCOL SHOULD THINK ABOUT
THE VALUE OF THE THINGS THAT
THEY--SO, POPULATIONS ARE
VULNERABLE BECAUSE THEY
TYPICALLY HAVE IMPAIRMENTS OF
THEIR ABILITY TO GIVE INFORMED
AND VOLUNTARY CONSENT.
IF YOU KNOW THAT AHEAD OF TIME,
YOU SHOULD HAVE A HIGHER BAR
GETTING THOSE PEOPLE IN
RESEARCH.
IF IT'S A RARE DISEASE PROTOCOL
AND YOU SHOULD KNOW, BUT YOU
SHOULD TAKE THE SCIENCE INTO
ACCOUNT.
IF THERE ARE 15 PEOPLE IN THE
WORLD WITH THAT DISORDER, YOU
KNOW THAT MATTERS.
SO, YOU KNOW THERE'S NO EASY
ANSWER.
>>YEAH.
>>ALL RIGHT.
WELL, I WANT TO THANK BOTH DAVID
FOR A VERY RICH AND INTERESTING
CASE THAT HE BROUGHT AND STEPHEN
FOR SOME FABULOUS SUGGESTIONS
AND COMMENTS.
WE REALLY APPRECIATE IT, MAYBE
SOMEDAY IN THE FUTURE STEPHEN WE
WILL DRAG YOU BACK HERE FOR
DISCUSSION OF ETHICS OF IRB
REVIEW WOULD BE GREAT BUT IN THE
MEAN TIME, THANK YOU GUYS AND
APPRECIATION OF EVERYBODY FOR
REALLY WONDERFUL SESSION AND
JUST A REMINDER THAT THE NEXT
ETHICS GRAND ROUNDS WHERE PEOPLE
ARE KEEPING TRACK IS THE FIRST
WEDNESDAY OF DECEMBER AT NOON
AND THAT WILL ALSO BE VIRTUAL
RIGHT HERE ON NIH VIDEOCAST.
HOPE TO SEE EVERYBODY THEN AND
IN THE MEAN TIME THANKS AGAIN,
YOU GUYS, BYE-BYE.