GOOD MORNING EVERYONE, AND
WELCOME TO SESSION 7-H A COUPLE
LOGISTIC ISSUES HERE.
SO WE'RE GOING TO -- SORRY WE'RE
GETTING STARTED JUST A MINUTE
LATE.
A COUPLE ADMINISTRATIVE
ANNOUNCEMENTS FROM ME.
HI, THIS IS HOLLY AGAIN.
I SENT YOU ALL AN E-MAIL
YESTERDAY.
TODAY IS THE LAST DAY.
WE'RE GOING TO SEND YOU THE
POST-COURSE ASSESSMENT LATER
TODAY WILL.
IF YOU HAVE FOLLOWED THE COURSE
LIVE, GO AHEAD AND TAKE IT AS
SOON AS YOU WOULD LIKE TO.
FOR THOSE OF YOU WHO NEED TO
SPEND SOME TIME REVIEWING
LECTURES AND TAKING QUIZZES, WE
WILL RE-SEND IT ON THE 16TH.
THE LAST DAY TO REVIEW RECORDED
LECTURES AND COMPLETE -- AND TO
COMPLETE QUIZ SZ TWO WEEKS FROM
TODAY, THE 15TH OF NOVEMBER AT
11:59 P.M. EASTERN TIME.
AND ON YOUR CERTIFICATES WE ARE
GOING TO PREPARE THOSE AFTER THE
15TH SO WE CAN GET ALL THE DATA
IN, YOU'LL GET IT BY DECEMBER 1
OR FOUR WEEKS AFTER CLASS, AS WE
ADVERTISED.
SO A QUICK REVIEW OF TOAVMENTD
FIRST THE WORD OF THE DAY IS
NONINVASIVENESS.
WE WERE GOING TO START WITH
DR. MARIELLE GROSS ON WEARABLES,
SHE'S RUNNING A LITTLE LATE, SO
SASKIA HENDRIKS HAS NICELY
STEPPED IN AND IS GOING TO DO
HER LECTURE ON IMPLANTABLE BRAIN
DEVICES.
THEN WE'LL HAVE DR. GROSS TALK
ABOUT WEARABLES, AND THEN WE'LL
HAVE VAS RAHM -- AND THEN WE'LL
HAVE VAS RAHIMZADEH RSZ TALK
WILL LLM'S.
SASKIA IS HERE AT THE NIH
BIOETHICS AND HAS JOINT
APPOINTMENT IN NEUROETHICS AT
THE NATIONAL INSTITUTE OF
NEUROLOGICAL DISORDERS AND
STROKES, FOCUSES HER RESEARCH ON
RESEARCH ETHICS AND THE ETHICAL,
SOCIAL AND LEGAL IMPLICATIONS OF
EMERGING TECHNOLOGIES, PRIMARILY
IN NEUROSCIENCE AND
REPRODUCTION, THEREFORE, SHE IS
THE PERFECT PERSON TO START US
OFF ON IMPLANTABLE BRAIN
DEVICES, AND IT'S A LOVELY
FOLLOW-UP TO THE LECTURE ON
POST-TRIAL ACCESS THAT WE HAD
LAST WEEK.
SO I'LL HAND IT OFF TO SASKIA.
>> THANK YOU SO MUCH, HOLLY.
IT'S A PLEASURE TO SPEAK HERE
TODAY.
OKAY.
SO I'M GOING TO TALK ABOUT BRAIN
IMPLANTS.
SO LET'S START HERE.
WHY ARE WE IMPLANTING DEVICES IN
PEOPLE'S BRAINS?
WELL, NEUROLOGICAL AND MENTAL
HEALTH DISORDERS ARE CAWGZ A
HIGH BURDEN OF DISEASE, BOTH IN
THE HAD U.S. AND WORLDWIDE.
HOWEVER, THERE HAVE BEEN
EXCITING DEVELOPS IN ENGINEERING
AND NEUROSCIENCE THAT THERE WE
MAY BE DEVELOPING DEVICES THAT
COULD ALLEVIATE THIS HIGH BURDEN
OF DISEASE.
SOME HAVE EVEN DESCRIBED THE
CREATION OF NEW THERAPEUTIC
TOOLS AND ETHICAL IMPERATIVE IN
THIS SPACE.
INDEED, SOME NEURAL IMPLANTS
HAVE ARECEIVED REMARKABLE
SUCCESSES SUCH AS FOR EXAMPLE
DEEP BRAIN STIMULATION FOR
PARKINSON'S DISEASE.
FOR THIS DEVICE, A SPEECH
PROCEDURE --
>> UCSF RESEARCHERS HAVE SHOWN
THAT FULL WORDS AND SENTENCES
CAN BE DECODED FROM THE BRAIN
ACTIVITY A PERSON WITH PARALYSIS
WHO IS UNABLE TO SPEAK.
DR. EDWARD ARE -- WORKED A --
WHO LOST THE ABILITY TO
ARTICULATE WORDS FIFTEEN YEARS
AGO, THE MAN HAS RELIED ON OTHER
LIMITED MEANS TO COMMUNICATE.
[MUSIC]
IN THIS STUDY, AN ELECTRODE
DEVICE WAS IMPLANT #-D OVER THE
BRAIN AREA THAT NORMALLY
CONTROLS THE VOCAL TRACT.
A QUESTION WAS DISPLAYED FOR THE
PARTICIPANT AND THE DEVICE
RECORDED BRAIN ACTIVITY WHILE HE
ATTEMPTED TO SPEAK IN REPLY.
A COMPUTER ALGORITHM TRANSLATED
THE BRAIN ACTIVITY PATTERNS INTO
WORDS AND SENTENCES IN REALTIME
HAD. -- IN REALTIME.
[MUSIC]
THE COMPUTER ALGORITHM WAS
TRAINED TO DIFFERENTIATE AMONG
50 WORDS THAT COULD GENERATE
OVER 1,000 SENTENCES.
WORDS WERE DECODE WD UP TO 93%
ACCURACY AT 18 WORDS PER MINUTE.
THIS IS THE FIRST TIME BRAIN
ACTIVITY IN THE SPEECH CORTEX OF
A PARALYZED PERSON HAS BEEN
DECODED INTO FULL WORDS.
[MUSIC]
THE ADVANCE PAVES THE WAY FOR
NEW TECHNOLOGY TO RESTORE
NATURAL AND RAPID COMMUNICATION
FOR PEOPLE WITH SEVERE PARALYSIS
.
>> OKAY.
SO AS YOU MIGHT IMAGINE,
HOWEVER, IN ORDER TO CREATE
THESE NEW DEVICES AS THEY ARE
THERAPEUTIC TOOLS, WE FIRST NEED
CLINICAL RESEARCH TO MAKE SURE
THEY'RE WORKING AND ARE
SUFFICIENTLY SAFE.
NOW, THIS CLIN -- THESE CLINICAL
TRIALS RAISE A NUMBER OF ETHICAL
CHALLENGES, AS YOU YOU MIGHT
IMAGINE.
OF COURSE THERE IS ALREADY
GUIDANCE ON HOW TO DO CLINICAL
RESEARCH ETHICALLY, AS YOU'VE
LEARNED DURING THE COURSE OF
THIS COURSE, AND WE CAN HEAVILY
DRAW ON THAT, ALSO FOR THIS
SPACE.
HOWEVER, SOME OF THE NUANCES AND
THE CONTEXT RELATED FACTORS IN
THIS SPACE REQUIRE SPECIFICATION
AND INTERPRETATION OF THIS
EXISTING GUIDANCE IN THESE
SPECIFIC CHALLENGES.
THE NIH BRAIN INITIATIVE
NEUROETHICS WORKING GROUP
IDENTIFIED THE ETHICS OF NEURAL
ARE BRAIN DEVICE AS A PRIORITY
AREA.
SO TODAY I'LL DISCUSS TWO
SPECIFIC ETHICAL CHALLENGES THAT
WERE IDENTIFIED AS CRITICAL TO
THIS TYPE OF RESEARCH.
FIRST IS THE ANALYSIS AND
ASSESSMENT OF RISK.
SECOND IS POST-TRIAL
RESPONSIBILITIES, AND I'LL SPEND
MOST OF MY TIME THERE.
SO LET'S START WITH RISKS.
SO DETERMINING THE TYPE AND
EXTENT OF RISKS IN THESE TYPES
OF TRIALS IS FUNDAMENTAL TO
EVALUATING THE ETHICS OF NEURAL
DEVICE STUDIES AS IT IS IN OTHER
TYPES OF TRIALS THIS.
ALLOWS US TO PROTECT RESEARCH
PARTICIPANTS FROM UNNECESSARY
HARM, TO INFORM THE RISK/BENEFIT
EVALUATION AND DETERMINE WHETHER
A STUDY IS ETHICAL TO CONDUCT
AND TO ENABLE PROPER INFORMED
CONSENT.
IN THE CONTEXT OF THESE TYPES OF
STUDIES, THERE ARE SIX SOURCES
OF RISKS THAT MAY COME UP IN
THESE TRIALS.
SOME OF THESE RISKS MAY HAVE
SPECIAL MEANING TO PATIENTS
BECAUSE THEY RELATE TO THE
BRAIN.
SO FIRST, SURGERY FOR IMPLANTING
OR REPLACING INVASIVE DEVICES
CAUSES RISKS, INCLUDING THOSE OF
LIKE HEMORRHAGE, STROKE AND
SEIZURES.
OF COURSE, THERE'S ALSO GENERAL
PERKS RI OPERATIVE COMPLICATIONS
THAT ARE RARE BUT CAN BE SEVERE
WHEN THEY OCCUR, LIKE DEEP VEIN
THROMBOSIS.
SECOND, HARDWARE THAT'S
IMPLANTED IN BRAINS POSES RISKS,
INCLUDING, FOR EXAMPLE N A LEAD
CAN BREAK, CAN MIGRATE OR
MALFUNCTION, SOME OF WHICH MAY
REQUIRE ADDITIONAL SURGERY, BUT
MAY ALSO CAUSE THINGS LIKE
BLEEDING AND SO ON.
THE STIMULATION OF THESE DEVICES
CAN CAUSE ADVERSE EFFECTS.
FOR EXAMPLE, WE'VE SEEN THINGS
LIKE SPEECH DISTURBANCES,
PARESTHESIAS AND EFFECTIVE
DISRUPTIONS WITH THE USE OF DEEP
BRAIN STIMULATION, DBS.
SIDE EFFECTS TEND ON DEPEND ON
THE LEVEL AND FOCUS OF THE
STIMULATION AND CAN OFTEN BE
SOMEWHAT ALLEVIATED BY ADJUSTING
THE SETTINGS OF THE DEVICE AND
STIMULATION, ALTHOUGH IN THIS
CASE SOMETIMES THIS INVOLVES
TRADE-OFFS WITH THE THERAPEUTIC
EFFECTS.
SOME STUDIES ALSO REPORT ON
EFFECTS OF DBS AND OTHER
DEVICES, ON COGNITION,
PERSONALITY, MOOD AND BEHAVIOR,
SOMETIMES DESCRIBED AS ATYPICAL
RISKS.
THESE CHANGES ARE REALLY POORLY
UNDERSTOOD, AND UNPREDICTABLE.
AFFECTS ON PERSONALITY OR
BEHAVIOR MAY BE INTEND OR
UNINTENDED, MAY BE CONSIDERED
BENEFICIAL OR HARMFUL AND MAY BE
EVALUATED DIFFERENTLY DEPENDING
ON WHO YOU ASK, THE PARENT OR
THE CAREGIVER OR SOMEONE ELSE.
WE NEED FURTHER RESEARCH TO
STUDY HOW OFTEN THESE TYPES OF
PERSONALITY CHANGES AND
BEHAVIORAL CHANGES OCCUR,
CHARACTERIZED, WHEN THEY ARE
PROBLEMATIC AND WEIGH HOW THESE
RISKS WEIGH AGAINST POSSIBLE
THERAPEUTIC BENEFITS.
AS I'M SURE IS NOT A SURPRISE TO
YOU AT THIS POINT IN THE COURSE,
RESEARCH ITSELF MAY ENTAIL SOME
INCREMENTAL RISKS, INCLUDING,
FOR EXAMPLE, RISKS OF PROCEDURES
THAT ARE CONDUCTED ONLY FOR
RESEARCH PURPOSES, LIKE
EXTENDING A CLINICALLY INDICATED
SURGERY IN ORDER TO DO MORE
MEASUREMENT OF THE BRAIN.
WE ALSO HAVE TO CONSIDER PRIVACY
AND SECURITY.
SO IN TERMS OF PRIVACY, WE
ANALYZE AGGREGATE GRAIN THE MAY
DISCLOSE SENSITIVE OR PRIVATE
INFORMATION ABOUT INDIVIDUALS,
AND THOSE SNROSTLED A TRIAL
SHOULD THINK CAREFULLY ABOUT
WEIGHING THE SOCIAL AND
SCIENTIFIC VALUES OF SHARING
DATA WITH THE PRIVACY INTERESTS
AND OTHER INTERESTS OF POTENTIAL
PARTICIPANTS.
THERE'S ALSO SOME CONCERN ABOUT
THIRD PARTY HACKING OF THE
DEVICE, RESULTING IN
UNAUTHORIZED ACCESS TO DATA, OR
EVEN CHANGING DEVICE SETTINGS,
WHICH COULD POSE SERIOUS HEALTH
RISKS FOR INDIVIDUALS.
I'M UNAWARE OF ANY OF THESE
CASES THAT HAVE ACTUALLY
OCCURRED, BUT THIS IS A RISK
THAT WE'RE BECOMING MORE AWARE
OF FOR IMPLANTED DEVICES IN
GENERAL.
ANOTHER THING TO CONSIDER IS
POTENTIAL FINANCIAL BURDENS.
FOR EXAMPLE, IF THERE IS A
COMPLICATION THAT LEADS TO
LONG-TERM DISABILITY, THIS MIGHT
HAVE A FINANCIAL IMPACT ON THE
PATIENT.
SO IN OUR VIEW, A RESEARCH
PROTOCOL SHOULD BE EVALUATED FOR
THESE SIX SOURCES OF RISKS IN
TERMS OF MAKING THE RISK/BENEFIT
CALCULATION.
SO AS ALWAYS, WE WANT TO
MINIMIZE THE RISKS AS FAR AS
POSSIBLE WITHIN WHAT'S POSSIBLE
FOR THE GOALS OF THE STUDY, AND
WE NEED TO MAKE SURE THAT THE
BENEFITS TO PARTICIPANTS AND
SOCIETY ARE PROPORTIONATE TO OR
OUTWEIGH THE RISKS OF ANY OF
THESE RESEARCH STUDIES.
IN THE CONTEXT OF BRAIN
IMPLANTS, THE RISKS ARE
SUFFICIENTLY HIGH, THAT WE TEND
TONT DO THIS -- THAT WE TEND TO
NOT DO THIS RESEARCH WITH BRAIN
IMPLANTS UNLESS THERE'S EITHER A
SUFFICIENT THERAPEUTIC BENEFIT
TO COMPENSATE THE RISK TO
INDIVIDUALS, OR WE ADD ON A
RESEARCH PROCEDURE TO A
CLINICALLY INDICATED BRAIN
SURGERY, SO FOR EXAMPLE, WE DO
SOME MEASUREMENTS TO BETTER
UNDERSTAND THE BRAIN ON
CONSENTING PATIENTS WHO ARE
UNDERGOING EPILEPSY SURGERY, FOR
EXAMPLE.
SO IN TERMS OF RISK LIMITS OF
ACCEPTABLE RISKS IN THESE TYPES
OF RESEARCH, OF COURSE IT
DEPENDS ON WHETHER IT HAS A
THERAPEUTIC INTENT OR NOT.
WITHIN RESEARCH, WITH A -- WHAT
ARE THE PROSPECTS OF BENEFITS.
AS IN ALL SURGERIES, RISKS ARE
CR DEPENDENT ON BENEFITS.
WITH TRIALS T PATIENTS WITH
TREATMENT-RESISTANT DISORDERS,
FOR WHOM THIS IS A LAST RESORT
OF SOME KIND, AND PATIENTS WITH
SIGNIFICANT BURDENS OF DISEASE.
SO MORE PROTECTION MAY BE
APPROPRIATE FOR CERTAIN
VULNERABLE GROUPS, SUCH AS
ADULTS IF WITH THE, WITH THE
CAPACITY -- OR A PARENT WITH
CAPACITY FOR CONSENT, AS ALWAYS,
PROTECTING VULNERABLE APARTMENT
ANTS BY EXCLUDING THEM FROM
RESEARCH ALSO DEPRIVES THEM OF
THE POTENTIAL BENEFIT TO
RESEARCH AND MAY EXPOSE THE
POPULATION TO MORE RISKS LATER
ON IF INTERVENTIONSES ARE USED
WITHOUT EVIDENCE IN THIS
SPECIFIC TARGET POPULATION.
SO IN TERMS OF RESEARCH WITHOUT
A PROSPECT OF BENEFIT, THESE
WOULD BE THE ADD-ON TYPE OF
STUDIES, THERE'S A NUMBER OF
QUESTIONS ABOUT HOW MUCH RISK IS
ACCEPTABLE FOR THESE TYPES OF
INTERVENTIONS WITHOUT PROSPECT
OF BENEFIT.
FOR EXAMPLE, HOW LONG IS IT
ACCEPTABLE TO PROLONG A SURGERY,
AND I BRAIN SURGERY, IN ORDER TO
JUST OBTAIN MORE KNOWLEDGE FOR
SOCIETY AND SCIENCE.
OKAY.
SO LET'S MOVE TO POST-TRIAL
RESPONSIBILITIES.
SO OBVIOUSLY SINCE THIS IS
CLINICAL RESEARCH, PARTICIPANTS
MAY OR MAY NOT BENEFIT FROM
PARTICIPATING IN A CLINICAL
TRIAL BUT IN MANY OF THESE CASES
OF A RESEARCH WITH THE PROSPECT
OF BENEFIT, THE PROSPECT OF
POTENTIAL BENEFIT IS A STRONG
MOTIVATOR FOR PARTICIPANTS TO
WANT TO PARTICIPATE IN THESE
STUDIES, AND FOR THE MOST PART,
GUIDED BY REGULATIONS AND
ETHICAL FRAMEWORKS,
PARTICIPANTS' INTEREST DURING
THESE TRIALS ARE CAREFULLY
PROTECTED.
HOWEVER, ONE AREA THAT REMAINS
INSUFFICIENTLY ADDRESSED, IN MY
VIEW, IS WHAT HAPPENS TO
PARTICIPANTS WITH THEIR MEDICAL
NEEDS RELATED TO THE DEVICE
AFTER THEIR TRIAL PARTICIPATION
ENDS.
SLOAT ME START WITH A CASE -- SO
LET ME START WITH A CASE, THIS
IS UNFORTUNATELY AN ACTUAL CASE
REPORTED BY JOE BAIRD.
THIS IS A PATIENT WITH SEVERE
EPILEPSY SINCE CHILDHOOD W A
PROFOUND IMPACT ON QUALITY OF
LIFE.
THIS PATIENT VOLUNTEERED FOR
FIRST IN HUMAN TRIAL FOR A BRAIN
COMPUTER INTERFACE WHICH USES
DATA TO PREDICT WHEN EPILEPTIC
PROCEDURES WERE ABOUT TO HAPPEN.
THE BRAIN COMPUTER INTERFACE
THEN ALERTED THE PATIENT,
ALLOWING THEM TO TAKE
PROPHYLACTIC MEDICATION SO THIS
PATIENT WENT FROM AN AVERAGE OF
THREE SEIZURES A MONTH TO NONE,
WHICH PROFOUNDLY IMPACTED HER
QUALITY OF LIFE, THE TYPES OF
ACTIVITIES SHE WAS ABLE TO
ENGAGE IN AND SO ON.
THEN, THE COMPANY EXPERIENCED
WHAT HAS BEEN DESCRIBED AS
FINANCIAL CONSTRAINTS, I BELIEVE
IT FOLDED, AND RECOMMENDED
EXPLANTATION.
LET'S SEE WHAT SHE SAYS, TO HELP
US UNDERSTAND WHAT THIS
EXPERIENCE WAS LIKE FOR THIS
PARTICIPANT.
I WISH I COULD HAVE KEPT IT.
I WOULD HAVE DONE ANYTHING TO
KEEP IT.
I WANTED TO STAY WITH IT.
I WOULD HAVE DONE ANYTHING.
I WOULD HAVE PAID MONEY, I WOULD
HAVE DONE ANYTHING I COULD HAVE.
TO THIS DATE, I'VE NEVER AGAIN
FELT AS SAFE AND SECURE, NOR AM
I THE HAPPY, OUTGOING CONFIDENT
WOMAN I WAS.
I ALWAYS FELT LIKE THERE WAS
PART OF ME MISSING, LIKE I HAD
FORGOTTEN OR LEFT SOMETHING
BEHIND, A PART OF ME.
JUST TO GIVE A LITTLE BIT OF A
DIFFERENT FLAVOR HERE, THIS IS
THE SECOND CASE A PATIENT WITH
TREATMENT-RESISTANT DEPRESSION
WHO HAD UNDERGONE A LOT OF
DIFFERENT CLINICALLY INDICATED
THERAPIES WITHOUT AN EFFECT, AND
SHE DECIDED TO PARTICIPATE IN A
TRIAL INVOLVING DEEP BRAIN
STIMULATION.
AFTER THE TRIAL, SHE WAS ALLOWED
TO KEEP THE DEVICE, AND SHE WAS
VERY HAPPY BECAUSE SHE WAS
FINALLY BENEFITING.
SO HER CLINICAL DEPRESSION
SCORES WENT DOWN.
SO HOWEVER, WHILE SHE HAD THIS
IMPLANT, WHICH WAS BENEFITING
HER, THE DEVICE AT THIS JUNCTURE
WAS NOT YET FDA APPROVED FOR
THIS INDICATION.
SO SHE SAYS, FOR ME, THIS DEVICE
IS NOT AN EXPERIMENT ANYMORE.
WE KNOW THIS WORKS.
THIS IS THE ONLY THING THAT DID
WORK.
IF I NEED A BATTERY REPLACEMENT
OR LEAD FIXED OR ANY OF THOSE
THINGS, IT'S A WAY TO KEEP ME
ALIVE.
SO I'M CONCERNED ABOUT, I WILL
NEVER KNOW FROM ONE SURGERY TO
THE NEXT IF THE NEXT ONE WILL BE
COVERED BY MY INSURANCE.
MANY.
OKAY.
SO UNFORTUNATELY, WE'VE SEEN
SEVERAL CASES IN THE MEDIA OVER
THE PAST YEARS IN WHICH PATIENTS
WERE LEFT WITH A DEFURNGHT
DEVICE AFTER GETTING -- DEFUNCT
DEVICE AFTER GETTING A BRAIN
IMPLANT.
FORMER PATIENTS WHO LACK ACCESS
TO THIS TYPE OF CARE CAN
OBVIOUSLY EXPERIENCE SYMPTOM
REBOUND BUT MAY ALSO EXPERIENCE
INCREASED RISKS AND/OR HIGH
OUT-OF-POCKET EXPENSES.
SO THE GENERAL CASE HERE IS
SOMETHING LIKE THIS.
A PATIENT ENROLLS IN A CLINICAL
TRIAL AND FORTUNATELY BENEFIT
FROM THE DEVICE.
DURING THE TRIAL THE PATIENT IS
WELL TAKEN CARE OF BY THE
CLINICAL TEAM, BUT AFTER THE
TRIAL ENDS, MANY PATIENTS WHO
EXPERIENCE BENEFIT FROM THE
DEVICE WANT TO KEEP IT.
AFTER ALL, MOST HAVE BEEN
TREATMENT-RESISTANT TO EXISTING
OPTIONS, MEANING THAT IF THIS
DEVICE WORKS, THIS IS THE ONE
THING THAT WORK FOR THEM.
PATIENTS, HOWEVER, WHO KEEP AN
IMPLANT MAY NEED CERTAIN TYPES
OF CARE TO MAINTAIN THEIR
BENEFITS AND MINIMIZE THEIR
RISKS RELATED TO THE IMPLANT.
THIS COULD RANGE FROM FOLLOW-UP
VISITS TO ADJUST STIMULATION
SETTINGS, BATTERY REPLACEMENT,
DEVICE REPAIR OR EVEN REMOVAL.
IN MANY CASES, HOWEVER, IN THE
U.S. AND SEVERAL OTHER
COUNTRIES, THERE'S NOT ALWAYS A
CLEAR PATHWAY TO RECEIVE THIS
CARE.
FOR EXAMPLE, INSURANCE MAY OFTEN
DENY COVERAGE FOR THE MOST
EXPERIMENTAL TYPES OF IMPLANTS.
THERE EXIST A POTENTIAL GAP IN
PATIENTS' ACCESS TO CLINICAL
CARE THEY NEED RELATED TO THEIR
DEVICE, THEIR RESEARCH
PARTICIPATION.
AND COMMONLY, THE AT RISK PERIOD
FOR THESE GAPS IN CARE IS
BETWEEN WHEN A PATIENT ROLLS OUT
OF THE TRIAL AND WHEN THE DEVICE
IS FDA APPROVE AND PRESUMABLY
INSURED BY -- COVERED BY
INSURANCE.
AND THIS PERIOD MAY LAST A
NUMBER OF YEARS.
BUT THERE ARE SOME OTHER CASES
THAT MAY ACTUALLY EXPAND FOR THE
PATIENT'S LIFETIME.
FOR EXAMPLE, SOME DEVICES NEVER
GET FDA APPROVAL, OR IN SOME
CASES, EVEN IF A DEVICE IS FDA
APPROVED, THE COMPANY GOES OUT
OF BUSINESS OR IT'S A
COMMERCIALLY UNVIABLE PRODUCT OR
SOMETHING ELSE HAPPENS AND
PATIENTS MAY LOSE ACCESS TO THE
CARE THAT THEY NEED.
SO WHAT ARE THE NEEDS THAT
PATIENTS HAVE AFTER THESE TYPES
OF TRIALS?
SO IT ALL STARTS WITH AN OBVIOUS
ONE THAT IS TO ANTICIPATE WHAT A
PATIENT NEEDS AFTER THE TRIAL
ENDS AND PLAN FOR IT.
SEVERAL PLANS MAY REQUIRE
ADVANCE PLANNING, FOR EXAMPLE,
NEGOTIATING BETWEEN DIFFERENT
STAKEHOLDERS.
BUT WE UNFORTUNATELY STILL SEE
HAPPEN THAT TRIALS WITH
IMPLANTED DEVICES ARE STARTED
BEFORE THE TEAM HAS REALLY
THOUGHT ABOUT WHAT HAPPENS AFTER
THE TRIAL ENDS, OR THEY DECIDE
TO RELY ON AD HOC
DECISION-MAKING, MEANING THAT
THEY'LL DECIDE WHAT TO DO WHEN
IT HAPPENS, WHICH CAUSES ANXIETY
FOR PATIENTS.
SO AFTER HEARING ABOUT PATIENTS
WHO LOST ACCESS TO THEIR
EXPERIMENTAL IMPLANTS, SOME
PARTICIPANTS ARE NOW INDICATING
THAT THEY DON'T WANT TO
PARTICIPATE IN THESE TRIALS
UNLESS SUFFICIENT PLAN IS IN
PLACE FOR POST-TRIAL CARE.
SO THIS IS PROBABLY THE LEAST
CONTROVERSIAL THING I'LL SAY
TODAY, WHICH IS WE SHOULD MAKE
SURE THAT PARTICIPANTS KNOW THEY
MIGHT NEED CARE AFTER THE TRIAL
ENDS RELATED TO THEIR IMPLANT
AND WHAT THEY CAN EXPECT IN
TERMS OF ACCESS TO THIS CARE.
SO THAT THEY CAN TAKE THIS
INFORMATION INTO ACCOUNT WHEN
THEY MAKE DECISIONS ABOUT
WHETHER OR NOT TO ENROLL IN A
TRIAL.
WE DON'T HAVE DATA ON THE
PROPORTION OF PATIENTS WHO ARE
TOLD THIS TYPE OF INFORMATION,
BUT IT SEEMS LIKE AT LEAST BASED
ON SMALL QUALITATIVE STUDIES
THERE'S AT LEAST A SIGNIFICANT
PROPORTION OF PATIENTS THAT
DON'T RECALL TALKING ABOUT THIS.
OF COURSE, IT DOESN'T MEAN IT
DIDN'T HAPPEN, BUT AT LEAST IT
SUGGESTS THAT THERE'S AN
OPPORTUNITY TO IMPROVE OUR
INFORMED CON SEBILITY PROCESS
RELATED TO THESE -- CONSENT
PROCESS RELATED TO THESE
QUESTIONS.
OKAY.
SO WE'VE ALREADY TALKED ABOUT
THE FIRST CASE, PATIENTS WHO ARE
EXPERIENCING SIGNIFICANT
CLINICAL BENEFITS MAY WANT TO
KEEP THE DEVICES.
AGAIN, WE DON'T HAVE ANY
ABSOLUTE OR RELATIVE NUMBERS
HERE.
WE JUST HAVE A SMALL, A COUPLE
OF SMALL QUALITATIVE STUDIES IN
WHICH ALMOST ALL PATIENTS WHO
EXPERIENCE SIGNIFICANT BENEFIT
FIT WANTED TO KEEP THE DEVICE,
BUT WE NEED MORE INFORMATION TO
KNOW WHICH PROPORTION THIS IS.
THERE IS, HOWEVER, ONE OTHER
GROUP WE HAVEN'T TALKED ABOUT
YET, AND THAT IS IN SOME CASES
THE RISK SHES EVEN IF THE DEVICE
IS NOT WORKING, THE RISKS OF
TAKING IT OUT ARE HIGHER THAN
LEAVING IT IN PLACE BECAUSE IT
REQUIRES ADDITIONAL BRAIN
SURGERY AND SO ON.
SO IN THOSE CASES, PATIENTS ALSO
HAVE A CLINICAL INTEREST TO KEEP
THE DEVICE.
HOWEVER, ONCE THEY HAVE AN
IMPLANTED, PATIENTS NEED A
NUMBER OF DIFFERENT THINGS,
INCLUDING POTENTIAL EMERGENCY
CARE FOR COMPLICATIONS RELATED
TO THE DEVICE, AS WELL AS
ROUTINE FOLLOW-UP CARE AND
DEVICE SUPPORT HAD AND REPAIR.
I WANT TO HIGHLIGHT A COUPLE OF
THINGS HERE.
9 ACCESS TO SPECIALIZED IT
CLINICIANS.
IN SOME CASES, THESE DEVICES ARE
SO NEW AND UNIQUE THAT IF A
PATIENT, FOR EXAMPLE, NEEDS
STIMULATION SECRETARIES CHANGED
OR NEEDS A LEAD REPLACED OR SOME
SORT OF SURGERY, IT'S REALLY
ONLY THE CLINICAL TEAM, THE
RESEARCH TEAM THAT PUT IT IN
THAT'S WILLING TO PROVIDE
THIS -- WILLING AND SPECIALIZED
ENOUGH TO PROVIDE THIS CARE.
SO THESE PATIENTS CAN BE HIGHLY
DEPENDENT ON THE CLINICAL
RESEARCH TEAM IN ORDER TO
RECEIVE THE POST-TRIAL CARE.
ANOTHER THING THAT'S GOING ON
HERE RELATES TO HARDWARE AND
SOFTWARE UPDATES.
SO SOME OF THESE DEVICES ARE
KIND OF LIKE APPLE PHONES,
MEANING THAT THEY ARE NOT
COMPATIBLE WITH EXISTING
COMMERCIALLY AVAILABLE HARDWARE
PIECES, SO THEY MIGHT HAVE
UNIQUE LEADS, THEY MIGHT HAVE
UNIQUE BATTERIES, THEY MIGHT
HAVE UNIQUE ALL SORTS OF
COMPONENTS AND SOFTWARE, WHICH
AGAIN MAKES THESE PATIENTS
UNIQUELY DEPENDENT ON IN THIS
CASE THE COMPANY TO CONTINUE TO
SUPPORT THIS HARDWARE OR
SOFTWARE.
OF COURSE, CLINICAL TEAMS MAY
RETIRE OR CHANGE RESEARCH FOCUS,
DEVICE COMPANIES, ESPECIALLY IF
IT'S STARTUPS, THEY MIGHT FOLD,
A PRODUCT MIGHT BE COMMERCIALLY
UNVIABLE, SO THINGS CAN HAPPEN
THERE, AND THIS IS OFTEN WHERE
WE'VE SEEN PROBLEMS OCCUR.
OF THE THINGS ON THIS LIST, ONLY
EMERGENCY CARE FOR COMPLICATIONS
OF THE DEVICE IS USUALLY
PROVIDED BY THE PATIENT'S
INSURANCE TION AS WELL AS
FOLLOW-UP VISITS ARE USUALLY
COVERED BY INSURANCE FOR
PATIENTS, IF THIS WAS COVERED
FOR THE CLINICAL INDICATION THEY
HAVE TO START WITH.
THE OTHER THINGS ARE NOT
NECESSARILY STRUCTURALLY COVERED
BY INSURANCE OR ANY OF THE OTHER
STAKEHOLDERS INVOLVED IN THESE
TRIALS.
OKAY.
SO WE'VE LEARNED FROM PATIENTS
THAT THERE WAS SOME OTHER THINGS
THEY MAY NEED OR AT LEAST WOULD
BENEFIT THEM AFTER A TRIAL ENDS.
FOR EXAMPLE, THE HEALTHCARE
SYSTEM CAN BE QUITE COMPLICATED.
ASSISTANCE IN COORDINATING CARE
CAN HELP THEM, FOR EXAMPLE, GET
THE THINGS COVERED THAT WOULD BE
COVERED FOR THEM IF THEY
PROVIDED NECESSARY PAPERWORK AND
SO ON.
THERE'S ALSO THE FACT THAT SOME
OF THESE DEVICES HAVE
IMPLICATIONS FOR OTHER TYPES OF
CARE.
FOR EXAMPLE, SOME IMPLANTS ARE
COMPATIBLE WITH MRI.
OTHER ONES ARE NOT, FOR CLINICAL
PROVIDER IT'S USEFUL TO TELL THE
DIFFERENCE.
SO THERE'S THIS NEED FOR
CLINICALLY RELEVANT INFORMATION
ABOUT THE DEVICE TO BE
ACCESSIBLE FOR CLINICIANS
OUTSIDE THE TEAM AND BECAUSE
RESEARCH RECORDS ARE NOT
NECESSARILY PUT INTO A MEDICAL
RECORD, THIS IS NOT APPLES THE
CASE CURRENTLY.
-- THIS IS NOT ALWAYS THE CASE
CURRENTLY.
I ALSO WANT TO EMPHASIZE THE
LAST POINT HERE, WHICH IS MENTAL
HEALTH SERVICES RELATED TO TRIAL
PARTICIPATION.
SO WE KNOW THAT PARTICIPATING IN
THESE TRIALS AND THEN NOT
BENEFITING OR DISCONTINUING TO
BENEFIT FROM A DEVICE OR EVEN IN
CERTAIN NONTHERAPEUTIC TRIALS
ENGAGEMENT IN THE RESEARCH CAN
HAVE A LARGE EMOTIONAL IMPACT
AND LARGE IMPACT ON THE MENTAL
WELL-BEING OF PATIENTS, AND WE
THINK THAT ESPECIALLY WHEN THEY
TRANSITION OUT OF A TRIAL OR
TRANSITION OUT OF SOMETHING, A
DEVICE, THEY MAY NOT BENEFIT
FROM MENTAL HEALTH SERVICES
RELATED TO THEIR TRIAL
PARTICIPATION, SO DON'T GET ME
LONG, THERE'S A LOT OF RESEARCH
THINGS OUT THERE THAT ARE AMAZE
AND GO CAN DO EVERYTHING THEY
CAN TO HELP THEIR PATIENTS OUT
THERE AFTER THE TRIAL, A LOT OF
TEAMS.
BUT WE HAVE TO RECOGNIZE THAT
THERE ARE LIMITATIONS IN TERMS
OF MISSION AND RESOURCES THAT
THE ORGANIZATIONS WHO ARE
INVOLVED IN THIS RESEARCH HAVE.
FOR EXAMPLE, NIH HAS NO LEGAL
AUTHORITY TO TRANSFER FUNDS ONCE
A TRIAL IS NO LONGER ACTIVE.
CMS IS BOUND BY COVERING THE
TYPES OF CARE THAT ARE INDICATED
BY LAW.
DEVICE COMPANIES MAY SIMPLY BE
UNABLE TO CONTINUE TO MAINTAIN A
VIABLE PRODUCT.
AS A RESULT, MOST OF THE CURRENT
PLANS ARE KIND OF LIKE A
PATCHWORK OF CONDITIONAL
ASSURANCES.
IT DOESN'T HELP THAT WITHIN AND
BETWEEN INVOLVED RESEARCH
INSTITUTIONS, FUNDERS, DEVICE
MANUFACTURERS, INSURANCING
RESEARCHERS, PATIENTS AND
CAREGIVERS, THERE MAY BE
DISAGREEMENT ABOUT WHAT TYPE OF
PLAN IS SUFFICIENT OR
APPROPRIATE AND HOW
RESPONSIBILITY SHOULD BE DIVIDE.
NOW, OF COURSE THE EXISTENCE OF
AN UNMET CLINICAL NEED DOESN'T
IMPLY A MORAL RESPONSIBILITY TO
PROVIDE CARE.
IN FACT, MANY CLINICAL NEEDS ARE
UNFORTUNATELY UNMET IN THIS
COUNTRY, WHICH LEADS US TO A
NORMATIVE QUESTION, THAT IS,
WHAT RESPONSIBILITIES, IF ANY,
DO PROFESSIONAL STAKEHOLDERS
HAVE TO FACILITATE OR PROVIDE
THIS CARE?
AND IT'S POSSIBLE I'LL COME OUT
SOMEWHERE DIFFERENT THAN JOE
HERE, I DON'T KNOW WHAT HE SAID
LAST WEEK, BUT BY WAY OF
REMINDER IN THAT THERE ARE
LARGER DEBATES ABOUT POST TRIAL
CARE, MOST OF WHICH HAVE FOCUSED
ON DRUGS, A LOT OF WHICH HAVE
FOCUSED ON HIV AND A LOT OF
WHICH HAS FOCUSED ON THE CONTEXT
OF INTERNATIONAL RESEARCH.
THERE ARE NO REGULATORY OR LEGAL
REQUIREMENTS TO PROVIDE THIS
CARE, BUT THERE HAVE BEEN
LONG-STANDING ETHICAL DEBATES
ABOUT WHAT RESPONSIBILITIES WE
HAVE.
SO HERE ARE WHAT I TAKE TO BE
THE MAIN ARGUMENTS FOR SOME
POST-TRIAL RESPONSIBILITIES.
SO THIS INCLUDES FIRST, IF
YOU'RE A PROFESSIONAL
STAKEHOLDER SNROSTLED A TRIAL
THAT'S -- INVOLVED IN A TRIAL
THAT'S IMPLANTING AN
EXPERIMENTAL DEVICE IN
SOMEBODY'S BRAIN, YOU MAY HAVE
SOME RESPONSIBILITY TO HELP
THESE PATIENTS PREVENT OR
AMELIORATE ANY HARMS THAT MAY
OCCUR TO THEM AS A CONSEQUENCE
OF THIS RESEARCH PARTICIPATION.
WE CALL THIS NONMALEFICENCE.
SIMILARLY, YOU MAY HAVE SOME
RESPONSIBILITY TO HELP ADVANCE
PATIENTS' INTERESTS, B HE
NEFICENCE, SOME EXPRESS THIS
ARGUMENT BY SAYING IT WOULD BE
KIND OF CRUEL TO GIVE A GUY SO
MUCH OF HIS LIFE BACK AND THEN
SNATCH IT AWAY, JUST BECAUSE OF
A FEW PENNIES, ALTHOUGH IT'S
MORE THAN A FEW PENNIES.
IN GENERAL, I THINK
NONMALEFICENCE IS ONE OF THE
STRONGEST ARGUMENTS FOR
POST-TRIAL RESPONSIBILITIES.
OKAY.
SECOND, SOME ARGUE THAT WE HAVE
POST-TRIAL RESPONSIBILITIES
GARNERED IN RECIPROCITY, THAT
IS, WE SHOULD PROVIDE POST-TRIAL
CARE IN RETURN FOR THE BURDENS
AND RISKS THE PATIENT UNDERWENT
TO ADVANCE THE SCIENCE.
SO FOR EXAMPLE, THIS PARTICIPANT
EXPRESSES THAT VIEW THAT IS IT
FELT LIKE HEY, LOOK, I LIKE YOUR
I AM PREGNANTINGS IN MY
BRAIRNTION I'M WALKING AROUND
WITH THIS -- MY BRAIN, I'M
WALKING AROUND WITH THIS, YOU
HAVE SOME RESPONSIBILITY TO, YOU
KNOW, LOOK AFTER ME.
OKAY.
NOW, SOME PEOPLE ARGUE FOR
POST-TRIAL RESPONSIBILITIES
RESPECT FOR PERSONS WRRKS THE
CONCERN IS THAT NOT PROVIDING
THIS TYPE OF CARE COULD BE
CONSTRUED AS USING A PARTICIPANT
AS A MEANS TOWARDS AN END.
AND FINALLY, SOME HAVE ARGUED
THAT THERE ARE SOME
RESPONSIBILITIES GROUNDED IN THE
RELATIONSHIP BETWEEN THE
RESEARCHER AND THE PARTICIPANT
THAT CREATES SOME SORT OF DUTIES
EVEN AFTER A TRIAL ENDS,
REFERRED TO AS A PARTIAL
ENTRUSTMENT RELATIONSHIP.
BUT THERE ARE ALSO SOME REASONS
TO THINK WHY THESE
RESPONSIBILITIES HAVE LIMITS,
AND THEY PRIMARILY COME DOWN TO
OPPORTUNITY COSTS, TO SUPPORT
POST-TRIAL CARE FOR
PARTICIPANTS, WE MIGHT HAVE TO
FOREGO OTHER THINGS, SUCH AS
IMPLEMENT FURTHER TRIALS TO
BENEFIT THE PATIENT POPULATION
AT LARGE, ASSUMING THAT THIS IS
WHAT THE MONEY WOULD OTHERWISE
BE SPENT ON.
SO AT THE CORE, THERE'S THIS
TENSION BETWEEN THE INTERESTS OF
FORMER PARTICIPANTS AND THE
INTERESTS.
SPEED OF THE RESEARCH AND
ADVANCING THE BEEN FACILITIES OF
THE POPULATION -- AND THE
BENEFITS OF THE POPULATION AT
LARGE.
THIS IS ACTUAL A REALLY FAMILIAR
TENSION AND RESEARCH ETHICS IN
GENERAL, AND I HOPE TO CONVINCE
YOU THAT WHEREVER WE PUT THIS
BALANCE, IT SHOULD GO A LITTLE
BIT MORE TOWARDS THE INTERESTS
OF THE PARTICIPANTS IN THESE
TYPES OF TRIALS.
WITHIN LIMITS.
SO THE GENERAL CONSENSUS OF
POST-TRIAL RESPONSIBILITIES WITH
SOMETHING LIKE THIS, WE HAVE
SOME RESPONSIBILITIES, THEY HAVE
LIMITS, AND WHATEVER THEY ARE,
THEY'RE SHARED AMONG THE
STAKEHOLDERS WHO PARTICIPATE IN
THESE TRIALS, SONLT JUST THE
RESEARCHER, BUT ALSO THE FUNDER
AND THE COMPANY AND ALL OF THIS.
AGAIN, I'M NOT SURE EXACTLY WHAT
JOE SAID, BUT THERE'S BEEN SOME
CHALLENGES IN OPERATIONALIZING
AND SPECIFYING THIS, BECAUSE
THIS IS PRETTY HIGH LEVEL, IT'S
HARD TO KNOW WHAT EXACTLY TO DO
IN A SPECIFIC CASE BASED ON THIS
GUIDANCE, AND SOME GROUPS LIKE
MRCT HAVE WORKED ON THE
SPECIFICATION, BUT THEY TEND TO
PURPOSEFULLY EXCLUDE DEVICES.
AND I DO THINK THAT DEVICES,
ESPECIALLY I AM PLANLTDED
DEVICES, ARE KIND OF A UNIQUE
CASE IN THIS CONTEXT.
SO WHY WOULD I SAY THAT?
OKAY.
SO I THINK IN GENERAL, THE
AMOUNT OF RESPONSIBILITIES WE
HAVE KIND OF DEPEND ON THE
CONTEXT OF THE TRIAL BECAUSE
THESE ARG THUMENTS WE JUST
DISCUSSED -- ARG THUMENTS WE
JUST DISCUSSED HAVE MORE
WEIGHTED IN CERTAIN CONTEXTS.
FOR EXAMPLE, BENEFICENCE AND
NONMALEFICENCE HAVE MUCH MORE
WEIGHT IN THE INTERESTS OF
PATIENTS RECEIVING THIS CARE IS
HIGHER.
IN THE CASE OF NEURAL IMPLANTS I
WOULD SAY THESE ARGUMENTS HAVE
QUITE SOME REACH, FIRST BECAUSE
THESE ARE TREATMENT-RESISTANT
PATIENTS WITH SIGNIFICANT
BURDENS OF DISEASE, SO THEIR
BENEFICENCE-BASED CLAIMS CAN BE
QUITE HIGH.
ALSO, NONMALEFICENCE IN THIS
CASE, OBVIOUSLY HAVING A
COMPLICATION RELATED TO A BRAIN
DEVICE CAN HAVE A DETRIMENTAL
IMPACT ON YOUR HEALTH, AND I
THINK DEVICES ARE KIND OF
DIFFERENT THAN PHARMACEUTICALS
IN TERMS OF NONMALEFICENCE IN
THE SENSE THAT FOR DRUGS, IF YOU
KEEP ON USING THEM AFTER THE
TRIAL ENDS, YOU CAN HAVE A
COMPLICATION AND THEN YOU HAVE A
NONMALEFICENCE-BASED
RESPONSIBILITY TO TAKE CARE OF
THAT.
IN THE CASE OF IMPLANTS, YOU CAN
HAVE A COMPLICATION FROM AN I AM
PLABT YOU RECEIVED TWENTY YEARS
AGO -- FROM AN IMPLANT YOU
RECEIVED TWENTY YEARS AGO,
RIGHT?
BUT ALSO EX-PLANTING AN IMPLANT
ENTAILS RISKS.
SO IN THE CASE OF IMPLANTS,
NONMALEFICENCE ALSO PROVIDES AN
ARGUMENT FOR KEEPING THE DEVICE,
AS WELL AS PROVIDE MORE WEIGHT
AFTER THE TRIAL ENDS.
OKAY.
RECIPROCITY TENDS TO HAVE MORE
WEIGHT FOR TRIALS WITH HIGHER
RISKS AND BURDENS, AGAIN, I TOOK
THIS TO BE THE CASE.
SOME OF THESE ESPECIALLY BC I
TRIALS, THEY INVOLVE NOT JUST
BRAIN SURGERY BUT ONE OR TWO
YEARS OF COMING INTO THE CLINIC
TO TRAIN WITH THE DEVICE FOR
MANY HOURS A WEEK.
THESE ARE LIKE REALLY
SIGNIFICANT BURDENS OF THE
TRIAL, SO TO SAY.
RESPECT FOR PERSONS, MORE WEIGHT
IF PATIENTS LACK ALTHOUGH
TIFERS, AGAIN, THESE ARE
TREATMENT VISITS IN PATIENTS.
AND THE RELATIONSHIP-BASED
ARGUMENTS HAVE MORE WEIGHT FOR
TRIALS, AGAIN, WITH HIGH RISK
AND BURDENS, MORE DEPENDENCY AND
STRONG RELATIONSHIPS.
SO WHAT I'M SAYING HERE IS I
DON'T KNOW THAT ANYTHING IS
REALLY UNIQUE ABOUT NEURAL
DEVICES, BUT IF YOU LOOK AT
THESE ARGUMENTS FOR PROVIDING
POST TRIAL CARE, IT SEEMS THAT
ALL OF THEM HAVE MORE WEIGHT IN
THE CASES OF THESE NEURAL
IMPLANTS.
SO IN GENERAL, I THINK
POST-TRIAL RESPONSIBILITIES ARE
HIGHER IN NEURAL IMPLANT TRIALS
THAN IN MOST DRUG TRIALS, ON
AVERAGE.
THE ONE THING I HAVEN'T TALKED
ABOUT YET IS THIS LAST BULLET
HERE, WHICH IS THE ASSOCIATION
OF THE BRAIN WITH THINGS LIKE
IDENTITY AND PERSONALITY.
SO THIS MIGHT MEAN THAT BRAIN
IMPLANTS INCLUDING THE BENEFITS
AND THE RISKS HAVE MORE MEANING
FOR PATIENTS.
I THINK WE STILL NEED MORE
EMPIRICAL AND CONCEPTUAL
RESEARCH TO FIGURE OUT HOW MUCH
WEIGHT TO GIVE TO THIS ARGUMENT.
SO HOW ABOUT NEURAL IMPLANTS
COMPARED TO OTHER IMPLANTS?
WELL, I ACTUALLY THINK MANY OF
THE ARGUMENTS THAT GIVE MORE
WEIGHT TO POST-TRIAL
RESPONSIBILITIES FOR NEURAL
IMPLANTS ALSO APPLY TO CERTAIN
TYPES OF OTHER IMPLANTS, FOR
EXAMPLE, THINK ABOUT CARDIAC
PACEMAKERS, FOR EXAMPLE, THEY'RE
PROBABLY RELATIVELY SIMILAR.
BUT THERE ARE OTHER IMPLANTS
THAT MAY BE SOMEWHERE ELSE ON
THE SPECTRUM, LIKE, FOR EXAMPLE,
ANTI-CONCEPTION IMPLANTS OR
MAYBE CERTAIN IMPLANTS FOR
DIABETES THAT ARE JUST MUCH
LOWER RISK RS EASIER TO TAKE OUT
AND SO ON.
I DO THINK THAT NEURAL DEVICE
VERCH RELATIVELY IN AN EARLY
STAGE COMPARED TO SOME OTHER
FIELDS OF MEDICINE THAT USUALLY
HL DHAISH USE A LOT OF IMPLANTS.
FOR EXAMPLE, CARDIOLOGY OR
ORTHOPEDICS OR SOMETHING LIKE
THAT, WHICH CREATES MORE GAPS
FOR PATIENTS.
SO FOR EXAMPLE H THESE DEVICES
TEND TO BE AT A MUCH MORE EARLY
STAGE, WHICH MEANS THAT THEY ARE
NONFDA APREUFERRED FOR DIFFERENT
INDICATION, PATIENTS DESCROONT A
CLINICALLY AVAILABLE
ALTERNATIVE, LIKE THERE ARE MANY
COCHLEAR IMPLANTS, FOR EXAMPLE,
ALREADY ON THE MARKET, IF YOU
GET AN EXPERIMENTAL ONE THAT
DOESN'T WORK OR IT WORKS, BUT
YOU CAN ALSO SWITCH TO ANOTHER
ONE PRESUMABLY.
SO THAT'S NOT THE CASE FOR THESE
NEUROIMPLANTS.
ANOTHER THING THAT HAPPENED IN
SOME OTHER IMPLANT FIELDS LIKE
CARDIOLOGY IS THEY ESTABLISH
COMPATIBILITY STANDARDS FOR
HARDWARE.
SO WE HAVEN'T DONE THAT YET FOR
NEUROSCIENCE.
NEWBORN-IMPLANTED IMPLANTS I
THINK ARE A LITTLE BIT
DIFFERENT.
MANY OF THE FACTORS THAT COME
TOGETHER FOR OUR IMPLANTS TO
INCREASE THE RESPONSIBILITIES
ARE LESS COMMON FOR NONIMPLANTED
DEVICES, FOR EXAMPLE, THERE'S NO
IMPLANT TO TAKE OUT, MAY TARGET
LESS SEVERE CONDITIONS, NOT
NECESSARILY TREATMENT-RESISTANT
PATIENTS, TRIALS MAY NOT BE AS
RISKY.
SO I THINK THE NON-IMPLANTED
DEVICES IN TERMS OF POST-TRIAL
RESPONSIBILITIES MAY BE MORE
LIKE DRUGS, FOR EXAMPLE.
ON THE OTHER HAND, GENE THERAPY
TRIALS HAVE MORE IN COMMON WITH
I AM IMPLANTS, BUT THAT'S
ANOTHER TALK.
OKAY.
SO WE MADE A COUPLE OF
RECOMMENDATIONS, AND SUGGEST
SOME POTENTIAL STRATEGIES FOR
DREARING THESE NEEDS -- FOR
ADDRESSING THESE NEEDS.
I'M GOING TO GO OVER ALL OF
THEM, BUT BASICALLY THE BASICS
ARE WE THINK THOSE INVOLVED IN
THESE TRIALS SHOULD ANTICIPATE
AND PLAN FOR POST-TRIAL NEEDS
AND PROPERLY INFORM
PARTICIPANTS.
WILL IT MIGHT BE THE CASE THAT
THIS WOULD REQUIRE OR IT WOULD
BE HELPFUL FOR FUNDERS, FDA'S OR
IRBS TO RECOMMEND OR ASSESS
THESE PLANS FOR CARE AND/OR THE
DISCLOSURE GUIDANCE, AND THE
BRAIN INITIATIVE IS IS ALREADY
DOING THAT AT THIS POINTED,
ASKING FOR A POST-TRIAL PLAN FOR
SOME OF THESE FUNDING
OPPORTUNITIES.
THE INFORMED CONSENT PIECE MAY
BENEFIT FROM REGULATORY
GUIDANCE, ALTHOUGH I WILL SAY
THAT THE RANKS ALREADY SAY WE
SHOULD DISCLOSE REASONABLY
FORESEEABLE RISKS, BURDENS AND
BENEFITS, AND IN MY VIEW, THAT
COULD BE INTERPRETED AS
INCLUDING RISKS, BENEFITS AND
BURDENS AFTER TRIALS END.
IT'S NOT SPECIFIED THAT WAY IN
THE RANKS, IT'S NOT INTERPRETED
THAT WAY BROADLY, BUT I THINK
MAYBE WE COULD INTERPRET IT THAT
WAY.
I ALSO THINK GENERALLY IF
PATIENTS HAVE A STRONG CLINICAL
INTEREST IN KEEPING THE DEVICE,
WE SHOULD REALLY TRY TO MAKE
SURE THEY CAN.
AND THEN FOR PATIENTS WHO KEEP
AN IMPLANT, I THINK WE SHOULD DO
OUR BEST TO FACILITATE ACCESS TO
EMERGENCY AND ROUTINE CARE AND
MINIMIZE OUT-OF-POCKET COSTS AS
FAR AS POSSIBLE.
IF WE HAVE TO SET PRIORITIES
BETWEEN WHAT TYPES OF CARE WE
SUPPORT, I THINK WE SHOULD FOCUS
ON RESPONSIBILITIES THAT ARE
GROUNDED IN NONMA LEF
NONMALEFICENCE BECAUSE I
THINK -- NONMA LEF SINCE BECAUSE
I THINK THIS IS THE STRONGEST
RESPONSIBILITY WE HAVE TO
PARTICIPANTS.
SOME MODELS FOR SHARING THE
COSTS FOR DOING THIS.
WE ARE CURRENTLY NEGOTIATING
DIFFERENT PIECES, MAYBE LIKE AN
INSTITUTION WAIVES THE FEE FOR
OPERATING ROOM FOR UNINSURED
PATIENTS AND THE MANUFACTURER
DONATES FIVE BATTERIES OR
WHATEVER.
THERE'S THIS OTHER MODEL WHICH
WE'RE INCREASINGLY LOOKING AT,
WHICH IS HAD THAT STAKEHOLDERS
ALL PAY INTO A SPECIFIC TYPE OF
INSURANCE, FUND OR ESCROW OR
SOME SORT OF COMBINATION OF
FUNDS, JUST LIKE THE VACCINE
INJURY FUND IN SOME WAYS, THAT
MIGHT COVER A SMALL PROGRAM OF
RESEARCH OR ALL RELEVANT
RESEARCH SUPPORTED BY A FUNDER,
MANUFACTURER OR AN INSTITUTION.
THIS MAY HAVE THE BENEFIT THAT
IT REDUCES THE FINANCIAL RISKS
FOR ANY OF THE INDIVIDUAL
STAKEHOLDER INVOLVED, WHILE ALSO
THE UPFRONT CONTRIBUTIONS MAY
PROVIDE MORE STABILITY OF
COVERAGE FOR PATIENTS.
SUCH AN INSURANCE PLAN OR FUND
COULD BE MANAGED BY AN IMPARTIAL
THIRD PARTY, WHICH WOULD REQUIRE
CLEAR ARTICULATED COVERAGE
CRITERIA.
ANOTHER THING I THINK WE SHOULD
CONSIDER FOR THIS PARTICULAR
CONTEXT IS POLICIES OR PRACTICES
THAT ALLOW COVERAGE TO HEALTH
INSURANCE BASED ON INDIVIDUAL
LEVEL BENEFIT.
SO RIGHT NOW COVERAGE DECISIONS
ARE LARGELY MADE ON GROUP LEVEL
BENEFITS, WHICH MAKE SENSE ON A
POPULATION LEVEL, EXCEPT IN
THESE CASES WHERE THERE'S STRONG
EVIDENCE FOR INDIVIDUAL LEVEL
BENEFIT, I THINK WE MIGHT LOOK
INTO OPPORTUNITIES FOR INSURANCE
COVERAGE TOO.
WE SHOULD TRY TO AVOID THESE
CASES WHERE THESE CLINICIANS
WITH HARDWARE OR SOFTWARE
UPDATES THAT PATIENTS ARE SO
DEPENDENT ON FALL AWAY AND THEN
ARE REALLY DIFFICULT TO RESTORE.
FOR EXAMPLE, WE MIGHT WANT TO
TRAIN A NETWORK OF CLINICAL
SPECIALISTS CAPABLE OF PROVIDING
THIS CARE AND COMPANIES SHOULD
CONSIDER STRATEGIES TO PROTECT
PATIENTS AGAINST LOSING ACCESS
TO A REASONABLE NUMBER OF
HARDWARE OR SOFTWARE, LIKE SOME
OF THE STRATEGIES ON THIS PAGE.
OKAY.
SO THE MAIN CONCERN ABOUT
PROVIDING MORE POST-TRIAL CARE
IS UNDULY AFFECTING SCIENTIFIC
PROGRESS, AS WE'VE TALKED ABOUT
BEFORE.
FOR EXAMPLE, THIS MIGHT
DISINCENTIVIZE COMPANIES AND
RESEARCH INSTITUTIONS IN
PARTICIPATING IN THIS TYPE OF
RESEARCH, OR IT MIGHT MOVE SOME
OF THIS RESEARCH TO DIFFERENT
JURISDICTIONS, WHERE THERE ARE
LESS STRINGENT REQUIREMENTS.
I THINK WE SHOULD CAREFULLY
CONSIDER THESE POTENTIAL
DRAWBACKS, ESPECIALLY IN TERMS
OF MANDATING REQUIREMENTS, AND
IN DETERMINING HOW
RESPONSIBILITIES ARE
OPERATIONALIZED AND DISTRIBUTED,
FOR EXAMPLE, SPECIFYING LIMITS
AND CRITERIA FOR SUPPORTING POST
TRIAL CARE SEEMS VERY REASONABLE
TO ME.
WE MIGHT ALSO WANT TO THINK
ABOUT INCENTIVES AND OTHER
POLICY-LEVEL STRATEGIES TO
CONSIDER AND REDUCE POTENTIAL
DETERRENT EFFECTS OF PROVIDING
THIS CARE.
OKAY.
SO LET ME END HERE.
TRIALS INCLUDING BRAIN IMPLANTS
CAN CAUSE SIGNIFICANT RISKS.
STILL, PATIENTS ARE VOLUNTEERING
IN THEM IN ORDER TO BENEFIT
SOCIETY AND IN THE HOPES OF
BENEFITING THEMSELVES.
NOW, THESE PATIENTS ARE AT RISK,
NOT JUST OF THE RISKS WRN THE
TRIAL, BUT ALSO AT RISK OF
SIGNIFICANT UNMET CLINICAL NEEDS
RELATED TO THEIR RESEARCH
PARTICIPATION AFTER TRIALS END.
SO YOU MIGHT DISAGREE WITH SOME
OF THE SPECIFICS THAT I PROPOSE,
AND WE CAN TALK ABOUT THAT.
BUT I HOPE TO CONVINCE YOU THAT
THE NATURE OF THESE BRAIN
IMPLANT TRIALS INCLUDING THE
RISKS GIVES US SOME
RESPONSIBILITY TO AT LEAST DO A
LITTLE BIT BETTER FOR THESE
PATIENTS AND ESTABLISH BEST
PRACTICES FOR POST-TRIAL CARE.
I LOOK FORWARD TO YOUR
QUESTIONS.
[APPLAUSE]
>> THANK YOU VERY MUCH, SASK
YARKS THAT WAS TERRIFIC,
AND --LY SASKIA, THAT WAS
TERRIFIC, THANK YOU FOR THE
QUICK CHANGE.
IT LOOKS LIKE JASMINE HAS A
QUESTION.
THERE ARE FOLKS IN THE ROOM YOU
CAN SEE OBVIOUSLY AND FOLKS IN
VIRTUAL LAND CAN SEND ME
QUESTIONS.
WE'LL START WITH JASMINE.
>> THANKS VERY MUCH FOR THIS.
I FOUND IT REALLY INTERESTING
AND PLAUSIBLE, BUT I WANTED TO
HEAR A LITTLE BIT MORE ABOUT THE
BENEFICENCE AND NONMALFEASANCE
REQUIREMENTS, BECAUSE IT SEEMS
LIKE, I MEAN, AS YOU SAY, THAT
THE NONMALFEASANCE BIT IS LIKE
DOING A LOT OF THE WORK, BUT I
GUESS IT WASN'T CLEAR TO ME WHY
THAT WE SHOULD THINK OF PULLING
LIKE SUPPORT AND NOT GIVING
POST-TRIAL ACCESS AS MALFEASANCE
IN A LOT OF CASES, BECAUSE, I
MEAN, IT SEEMS LIKE IF THERE'S A
CHANCE FOR INFECTION OR
COMPLICATIONS, THAT SEEMS LIKE
MALFEASANCE, BUT IT SEEMS LIKE
MOST OF WHAT'S AT ISSUE IS
THEY'VE LIKE REALLY GOTTEN USED
TO THESE BENEFITS, AND IT'S GOOD
FOR THEM TO HAVE THESE BENEFITS,
AND PULLING THEM LIKE CAUSES A
KIND OF EMOTIONAL HARM, BUT IT
SEEMS LIKE IT'S KIND OF JUST AN
EMOTIONAL HARM THAT'S A REACTION
TONTD HAVING THE BENEFIT.
-- TONT HAVING THE BENEFIT.
SO IKS -- TO NOT HAVING THE
BENEFIT.
I GUESS I WAS HOPING YOU COULD
SAY A LITTLE MORE ABOUT THAT.
>> THANK YOU FOR THE OPPORTUNITY
ON CLARIFY THAT.
I AGREE WITH YOU, BASICALLY NEW
YORK STOCK EXCHANGE THE BENEFITS
OF A DEVICE, TO ME THAT'S A BEEN
HE SINCE BASED, IF WE HAVE AN
OBLIGATION, THAT'S A BENEFICENCE
BASE.
THAT'S WHAT WE'VE SEEN IN MANY
OF THESE CASES.
THERE ARE A COUPLE OF PEOPLE WHO
HAVE ARC YOU HAD FOR
NONMALEFICENCE CLAIMS RELATED
TOP THE PSYCHOSOCIAL HARMS OF
LOSING ACCESS TO A DEVICE, SO
THERE IS SOME LITERATURE ABOUT
THAT WHICH YOU JUST BROUGHT UP,
BUT I THINK TO ME THE MA LEF
SINCE -- MALEFICENCE COMES INTO
PLAY NOT JUST WHEN COMPLICATIONS
IMURT ALSO THE ROUTINE CARE
THAT'S REQUIRED TO CONTINUE TO
REDUCE SIDE EFFECTS AND REDUCE
THE CHANCE OF COMPLICATIONS OF
HAVING A BRAIN IMPLANT.
IT ALSO COMES UP WHEN IN THE
CONTEXT OF EXPLANTATION OF THESE
DEVICES.
SO SOME TRIALS PLAN ON BASIC
EX-PLANTING THE DEVICE AFTER THE
STUDY ENDS, WHICH CAN BE
APPROPRIATE IN CERTAIN CONTEXTS,
BUT THAT INVOLVES ADDITIONAL
RISKS TO YOUR PARTICIPANT.
SO EXPLANTATION I THINK OR
AVOIDING EXPLANTATION ALSO CAN
BE SEEN AS A NONMALEFICENCE
BASED DUTY.
DOES THAT HELP?
>> THANKS, THAT WAS VERY
HELPFUL.
>> YEAH, GREAT QUESTION.
>> CAROLINE, GO AHEAD.
>> HI.
THANK YOU, SASKIA.
I HAVE TWO QUESTIONS.
ONE OF THEM IS I GUESS MORE
LOGISTICAL.
IT SEEMS LIKE A BIG PART OF THE
TALK WAS LIKE COST INCENTIVES
FOR COMPANIES WHO ARE DEVELOPING
THESE DRUGS AND THAT OFTENTIMES
THEY COME IT A POINT WHERE
THERE'S NOT COMMERCIAL VIABILITY
HAD, AND I'M WONDERING IF YOU
COULD TALK A LITTLE BIT MORE
ABOUT WHY THAT MIGHT BE THE CASE
FOR NEURAL DEVICES AS OPPOSED TO
PHARMACEUTICAL DEVICES AND WHAT
SPECIAL CONSIDERATIONS THERE ARE
IN TERMS OF ENSURING COMMERCIAL
VIABILITY AS WELL AS FDA
APPROVAL ASK HOW THAT MIGHT
DIFFER FROM PHARMACEUTICALS.
AND THEN MY SECOND QUESTION WAS
LAST WEEK JOE TALKED OR BROUGHT
UP THE POINT THAT PERHAPS THE
POST-TRIAL BENEFITS
RESPONSIBILITY STEMS FROM LIKE A
SPECIAL -- OR WHETHER OR NOT
RESEARCHERS SHOULD TAKE ON THE
RESPONSIBILITY OF LIKE A
DOCTOR-PATIENT RELATIONSHIP AND
LIKE WHETHER OR NOT THAT MIGHT
HAVE LIKE SPECIAL APPLICATIONS
IN THIS CASE BECAUSE THE IMPLANT
IS IMPLANTED IN THEM AND YOU
CAN'T TAKE THEM OUT, AND IT'S
LIKE SO INTIMATELY RELATED TO
THEIR CARE AND WHETHER OR NOT WE
SHOULD APPLY LIKE CLINICAL
RESPONSIBILITIES TO POST-TRIAL
CARE, WHICH MIGHT HAVE A HIGHER
STANDARD THAN RESEARCH
RESPONSIBILITIES TO THE PATIENT.
>> GREAT QUESTIONS.
THANK YOU.
LET ME START WITH THE SECOND
ONE.
SO YES, SOME ARGUE FOR POST
TRIAL RESPONSIBILITIES GROUNDED
IN THE RELATIONSHIP BETWEEN THE
RESEARCHER AND THE PATIENT, AND
MANY OF THE PEOPLE I'VE SPOKEN
TO WHO THINK THAT'S -- WOULD
ARGUE THAT THOSE
RELATIONSHIP-BASED
RESPONSIBILITIES GET STRONGER IF
RELATIONSHIPS ARE TIGHTER AND IF
PATIENTS ARE MORE DEPENDENT ON
THE RELATIONSHIP WITH THE
SPECIFIC CLINICIAN, WHICH TENDS
TO REALLY BE THE CASE IN THESE
TYPES OF TRIALS OR BASED ON A
LOT OF THESE TRIALS, I'M
GENERALIZING A LITTLE BIT,
BECAUSE THEY INVOLVE SUCH A
CLOSE COLLABORATION WITH THE
NEUROSURGICAL TEAM AND THE
PATIENT TO LEARN HOW TO WORK THE
MACHINE FOR THE PATIENT'S
BENEFIT BASICALLY AND TO CONDUCT
THE RESEARCH, AS WELL AS A HIGH
DEPENDENCY OF THE PATIENT ON
THIS SPECIFIC INDIVIDUAL.
SO I THINK, I DO THINK THAT
INCREASES THE RESPONSIBILITIES
BASED ON THE RELATIONSHIP FOR
THESE TYPES OF TRIEMS.
I'M NOT SURE -- FOR THESE TYPES
OF TRIALS.
I'M NOT SURE I WOULD -- TO ME,
CHARACTERIZING THESE NEEDS AS
RELATED TO THE RESEARCH AS
OPPOSED TO GENERAL CLINICAL
NEEDS SERVES THE PURPOSE THAT,
FIRST, I MEAN, THEY ARE CAUSALLY
CONNECTED TO RESEARCH, OF
COURSE, BUT ALSO THERE ARE SO
MANY NEEDS A -- THERE ARE SO
MANY CLINICAL NEEDS A PATIENT IN
THIS COUNTRY ARE UNMELT AND
DOESN'T PROVIDE CLINICIAN
NECESSARILY OBLIGATION TO MEET
THOSE NEEDS, SO I THINK WE HAVE
A LARGER OBLIGATION FOR
RESEARCH-BASED CLINICAL NEEDS
BECAUSE THE PATIENT TOOK THEM ON
ON BEHALF OF TO BENEFIT SOCIETY
AND WE ARE AS A SOCIETY
BENEFITING FROM THEIR RISKS AND
BURDENS THAT THEY UNDERTOOK, AND
WE'RE -- YEAH.
SO I THINK THERE'S SOMETHING
THAT THE RESEARCH PIECE DOES
THERE, WHICH MAKES ME WANT TO
NOT JUST REFER TO THESE AS
CLINICAL NEEDS NECESSARILY.
IN RELATION IT YOUR FIRST
QUESTION ABOUT VIABILITY OF
DRUGS VERSUS DEVICES AND THE
COMMERCIALIZATION THEREOF, I
ACTUALLY THINK THAT'S A GOOD
QUESTION.
I DON'T KNOW IF THERE'S
STRUCTURAL EVIDENCE ON WHETHER
PHARMACEUTICALS OR DRUGS ARE
MORE OR LESS LIKELY TO BE
COMMERCIALLY VIABLE THAN
DEVICES.
I'M SURE WHAT THE DATA SAYS ON
THAT ONE.
I DO THINK THIS IS A SPACE WHERE
THERE ARE A NUMBER OF STARTUPS.
COMMERCIAL VIABILITY TENDS TO BE
HARDER FOR A SMALLER POPULATION
SIZES, SO LIKE RARE DISEASES,
BUT THOSE ARE FOR BOTH DEVICES
AND DRUGS TOO, SO I THINK I'LL
HAVE TO GET BACK TO YOU ON THE
DATA ON THAT ONE.
>> WE DO KNOW FROM A COUPLE OF
LECTURES AGO HOW, YOU KNOW, THE
NUMBER OF PHARMACEUTICALS THAT
START OUT IN PHASE I THAT GO TO
PHASE II, THAT GO TO PHASE III,
THERE'S A PRETTY HUGE DROPOFF.
SO IF WE THINK OF MANY OF THESE
TRIALS AS PHASE I, PHASE II, WE
KNOW BASED ON WHAT WE KNOW ABOUT
MORE COMMON DRUG COMPOUNDS THAT
THERE'S A BIG FALLOFF, AND THE
DIFFERENCE HERE, RIGHT, IS THAT
IT'S IMPLANTED IN YOUR BRAIN
VERSUS SOMETHING THAT YOU'RE
TAKING IN.
>> (AWAY FROM MICROPHONE).
>> IT DOESN'T ALWAYS WORK THAT
WAY, AND IN SOME OF THESE CASES,
FOR EXAMPLE, DBS FOR DEPRESSION,
WE'VE TRIED THAT FOR A LONG
TIME, AND ESPECIALLY THE EARLY
WORK, IT APPEARED TO HAVE
BENEFITS FOR SMALL POPULATIONS
THAT WE COULDN'T IDENTIFY AHEAD
OF TIME.
SO NOT FOR THE ENTIRE GROUP, BUT
YES, FOR LIKE WHATEVER, A SMALL
NUMBER OF PATIENTS WITHIN THAT
TRIAL.
PART OF IT IS BECAUSE WE JUST
DON'T KNOW HOW WELL -- WE DON'T
UNDERSTAND THE BRAIN PERHAPS AS
WELL AS WE WOULD LIKE.
>> KELLY, AND THEN WE HAVE A
COUPLE QUESTIONS FROM OUR
VIRTUAL AUDIENCE.
>> HI, SASKIA.
SO I WAS WONDERING, ESPECIALLY
WITH THESE, THE KIND OF LIKE
WITH NEURAL IMPLANTS BECAUSE
THEY TEND TO BE SO KIND OF LIKE
EARLY STAGE, WHETHER THERE'S
MAYBE LIKE -- LIKE WHETHER YOU
COULD SORT OF JUSTIFY PROVIDING
THE SORT OF POST-TRIAL CARE AS
AN EXTENSION OF LIKE AN ABILITY
TO DO RESEARCH, JUST BECAUSE IT
SEEMS LIKE, YOU KNOW, IF YOU
HAVE A PATIENT WHO HAS THIS
IMPLANT AND MAYBE LIKE TEN YEARS
DOWN THE LINE, YOU KNOW, THE
DEVICE STARTS TO MALFUNCTION,
THAT SEEMS LIKE SOMETHING THAT
WOULD BE IMPORTANT SAFETY AND
EFFICACY DATA TO BE ABLE TO
COLLECT RS EVEN IF IT'S WITH A
VERY SMALL END, SO I WAS JUST
WONDERING LIKE IF YOU THINK THAT
BECAUSE OF THE NATURE OF NEURAL
IMPLANT RESEARCH, LIKE IF THAT
WOULD BE KIND OF A VIABLE
ARGUMENT TO MAKE.
>> TO SOME DEGREE I THINK YES.
I MEAN, THE FDA REQUIRES THE
ADMINISTRATION OF SOME ADVERSE
EFFECTS GENERALLY SPEAKING, SO
SOME OF THAT DATA IS ALREADY
BEING COLLECTED, EVEN IF WE
DON'T TAKE CARE OF PATIENTS.
THERE ARE SOME STUDIES OR TEAMS
THAT IF HOPE TO DO LONG-TERM
FOLLOW-UP STUDIES OR USE
LONG-TERM FOLLOW-UP STRATEGIES
STUDIES AS A STRATEGY TO
CONTINUE TO PROVIDE CARE FOR
PARTICIPANTS, WHICH I THINK IS A
FINE STRATEGY.
THE ONLY PROBLEM I SEE WITH IT
IS RELYING ON THAT STRATEGY IF
YOU HAVEN'T YET SECURED FUNDING
FOR FOLLOW-UP TRIALS BECAUSE YOU
MIGHT NOT THEN GET THAT FUNDING,
AND IF THAT WAS YOUR PLAN, THAT
MIGHT FALL TRUE.
BUT I DO THINK THAT FOLLOW-UP
STUDIES CAN PLAY AN IMPORTANT
ROLE IN THIS AND PERHAPS LIKE
ONE OF THE WAYS OF THINKING
ABOUT SOLUTIONS WOULD BE TO
THINK ABOUT HOW WE CAN SECURE
THE MORE LONG-TERM HORIZON.
ONE OF THE CHALLENGES IS THAT
SOME OF THESE NEEDS MIGHT BE
LIKE FOR A PATIENT'S LIFETIME,
SO THAT'S A LONG TIME FOR A
FOLLOW-UP STUDIES.
MUCH.
>> GREAT. WE HAVE A COUPLE MORE
MINUTES.
I HAVE A COUPLE OF QUESTIONS
FROM THE VIRTUAL AUDIENCE.
SO YOU VERY BRIEFLY TOUCHED ON
THIS TOPIC, BUT DALIP WONDERS
SHOULD WE BE WORRIED ABOUT THE
SORT OF CONFLICT OF AUTONOMY
BETWEEN AN INDIVIDUAL AND A
MACHINE THAT IS IMPLANTED?
WE MIGHT NOT BE THERE YET, BUT
THAT MIGHT EXAGGERATE SOME OF
THE WORRIES THAT NOT KNOWING HOW
PERSONALITY BE CHANGES MAY
OCCUR.
>> YEAH.
THERE IS A LITERATURE ABOUT THAT
QUESTION, AND IT'S GETTING MORE
ATTENTION NOW THAT SOME OF THESE
DEVICES ARE USING AI TO IMPROVE
THEIR OWN ALGORITHMS, SO THAT
MAKES IT MORE OF A BLACK BOX OF
WHAT'S HAPPENING IN YOUR BRAIN,
AND THERE ARE -- I MEAN, THERE
ARE DEFINITELY CONCERNS RELATED
TO DIMINISHING AUTONOMY BASED ON
THESE TYPES OF DEVICES, FOR
EXAMPLE, THE GROUP IN SEATTLE
REPORTS ON SOME OF THESE
EFFECTS, BUT AT THE SAME TIME, I
THINK IT'S IMPORTANT TO
APPRECIATE THAT FOR MANY
PATIENTS, IF THESE DEVICES WORK,
THEY ACTUALLY ENHANCE AUTONOMY
SIGNIFICANTLY BECAUSE THEY ALLOW
PATIENTS TO DO SO MUCH MORE OF
THEIR OWN ACTIVITIES.
SO THERE ARE -- BUT I THINK
THERE ARE SOME COMPLEX
PHILOSOPHICAL AND EMPIRICAL
QUESTIONS THAT WE ARE JUST
DELVING INTO.
>> GREAT.
SO FOLCMON SCTION, HAVE -- ASKS,
HAVE COMPANIES FAILED TO PROVIDE
POST-TRIAL CAIRKS ARE THERE SORT
OF FOLLOW-UP STORIES TO THE ONES
YOU SHARED ABOUT PEOPLE WHO
ENCOUNTER HARM BECAUSE THEY HAVE
A DEVICE THAT ISN'T EX-PLANTED,
FOR EXAMPLE?
>> YES.
SO THAT'S WHY THE QUICK VERSION.
>> THERE ARE PEOPLE -- THERE ARE
PEOPLE WHO HAD TO HAVE AN
EX-PLANT BECAUSE THE COMPANY
FOLDED, THERE ARE PEOPLE WHO ARE
NOW WALKING AROUND WITH IMPLANTS
WHO ARE NOT SUPPORTED, SO THEY
CAN'T USE THEM, THEY MIGHT
NOT --
>> OR TURNED OFF, BASICALLY.
>> THEY'RE TURNED OFF, YEAH, OR
THEY'RE STILL TURNED ON BUT
THEY'RE JUST WAITING FOR THE
BATTERY TO DIE OUT AND THEN FOR
THEM TO LOSE ACCESS.
IN SOME CASES, THERE ARE OTHER
ROUTES FOUND TO HELP THESE
PATIENTS, LIKE SOME OF THIS
ACTUALLY COMES DOWN TO MONEY AND
IN SOME CASES YOU CAN FIND MONEY
IN DIFFERENT PLACES, BUT IT'S
THE EXPERTISE AND THE HARDWARE,
THE COMMERCIALLY PROPRIETARY
HARDWARE PIECES THAT ARE REALLY
HARD TO REPLACE EVEN IF YOU HAVE
MONEY, IF THERE IS TR A KINK IN
THERE.
>> ONE LAST QUESTION AND TWO
FOLKS EMPLOYED THIS, AND I DON'T
THINK YOU MENTIONED IT AMONG
YOUR RECOMMENDATIONS, BUT IS
THERE ANY EFFORT SORT OF BACK TO
KELLY'S POINT, TOO, OF THE NIH
AS A FUNDER, FOR EXAMPLE, YOU
KNOW, CREATING EITHER THE TYPE
OF SYSTEM THAT WOULD BE LIKE THE
VACCINE -- COMPENSATION SYSTEM
OR ALLOWING INVEST GAY
INVESTIGATORS TO APPLY TO SOME
FUND OR ACCESS OF MONEY TO
PROVIDE THAT CARE?
>> THANK YOU.
GOOD QUESTION.
FIRST I WANT TO EMPHASIZE THAT
THESE RESPONSIBILITIES I THINK
ARE SHARED, SO IT'S NOT JUST
THIS FUNDER, IT'S NOT JUST THE
COMPANY, IT'S NOT JUST THE
RESEARCHER, I THINK THERE ARE
SEVERAL EFFORTS IN THE FEEMED TO
TRY TO ADDRESS THIS PROBLEM,
THERE'S MORE AWARENESS ARISING
AMONG COMPANIES, AMONG FUNDERS,
AMONG OTHERS.
NIH HAS CERTAIN LEGAL LIMITS,
LIKE WE'RE NOT ALLOWED TO
TRANSFER FUNDS AFTER A TRIAL P
ENDS, FOR EXAMPLE, WHICH POSES
LIMITATIONS IN WHAT WE CAN --
ARE ALLOWED BY LAW TO DO.
WE ARE LOOKING INTO IT IS WHAT I
CAN SAY.
>> GREAT.
WELL, THANK YOU SO MUCH, SASKIA,
FOR JOINING US.
[APPLAUSE]
AND THOSE WHO ARE HERE ON CAMPUS
CAN HAVE YOU AS A REFERENCE
MOVING FORWARD.
THANK YOU.
WE'LL MOVE ON TO OUR NEXT
PRESENTATION.
IT'S MY PLEASURE TO INTRODUCE
MARIELLE GROSS, WHO IS JOINING
US THIS MORNING.
SHE IS AN ASSISTANT PROFESSOR OF
BIOETHICS AND RURAL WOMEN'S
HEALTH AND A RURAL WOMEN'S
HEALTH PHYSICIAN AT THE
UNIVERSITY OF PITTSBURGH AND
JOHNS HOPKINS, SHE STUDIES THE
ETHICS OF EVIDENCE, INFORMATION
TECHNOLOGY AND HEALTH DATA
SUPPLY CHAINS THROUGH THE LENS
OF STRUCTURAL JUSTICE.
SHE IS GOING TO TALK WITH US
TODAY ABOUT ETHICAL ISSUES
RELATED TO WEARABLES IN
RESEARCH.
I'LL HAND IT OVER TO MARIELLE.
>> THANK YOU, HOLLY.
HELLO.
GOOD AFTERNOON, LATE MORNING.
I'M HAPPY TO BE HERE.
DOES THAT SOUND GOOD TO
EVERYBODY?
I THINK THERE WAS A LITTLE BIT
OF A --
>>> ITS PROBABLY ME, BECAUSE I
HAVE A MIC, TOO, THERE WAS A
LITTLE FEEDBACK WHEN I STEPPED
UP.
>> OKAY.
I'M HAPPY TO BE HERE.
SO BEFORE WE GET INTO TALKING
WITH ETHICS OF WEARABLES, I JUST
WANT TO MAKE TWO QUICK
DISCLOSURES, ISN'T WE WILL ALSO
GET INTO SOME OF THE SPECIFICS
OF THE TECHNOLOGIES.
ONE IS THAT IN ADDITION TO MY
ROLE AS A PROFESSOR, I ALSO HAVE
A STARTUP COMPANY THAT'S
FOCUSING NOT ON ANY OF WEARABLES
BUT ON SOME OF THE TECHNOLOGIES
AND THE BLOCKCHAIN SPACE THAT
HAVE POTENTIAL I THINK TO SOLVE
SOME OF THE CHALLENGES IN THE
WEARABLE SPACE, SO I WANTED TO
DISCLOSE THAT.
THE OTHER THING THAT OCCURRED TO
ME AS I WAS PREPARING FOR THIS
TALK IS THAT MY BROTHER RUNS A
COMPANY THAT MAKES WEARABLES,
CALLED INNOVATIVE EYEWEAR AND
IT'S A SMART GLASSES COMPANY, SO
I WANTED TO DISCLOSE THAT AS
WELL, BUT IT CAN ALSO BE A
SOURCE OF SOME OF THE PERSONAL
EXPERIENCES THAT I'VE HAD IN
GROWING UP AROUND THESE
TECHNOLOGIES AND TRYING TO
FIGURE OUT HOW TO DO GOOD WITH
THEM, AS WELL AS SOME OF THE
INHERENT CHALLENGES.
SO THE FASCINATING THING ABOUT
WEARABLES IS THAT THEY'RE REALLY
INTERTWINED WITH THE HUMAN
EXPERIENCE, AND THEY DATE FAR
BACK BEFORE THE SORT OF DIGITAL
WEARABLES THAT WE TEND ON THINK
OF.
RIGHT?
OUR SHOES, OUR GLASSES.
THESE ITEMS ARE WEARABLE
TECHNOLOGY, AND IN FACT, THEIR
PERMANENCE AND EMBEDDEDNESS IN
OUR LIVES AND OUR EXPERIENCES
AND SORT OF OUR RELIANCE UPON
THEM, RIGHT, YOU MIGHT THINK
ABOUT ALL THE THINGS THAT WE
JUST TALKED ABOUT IN LIGHT OF
BRAIN IMPLANTS ALSO PROBABLY
APPLY TO GLASSES, RIGHT, WHICH
IS SEEMINGLY FAR LESS INVASIVE,
BUT SOME OF THE MORAL ATTENTIONS
AND BENEFITS AND RISKS ARE
REALLY QUITE SIMILAR.
FUNDAMENTAL, BASIC PRINCIPLES,
THINKING ABOUT WEARABLES AND
WHAT WE'RE TALKING ABOUT TODAY,
WE'RE REALLY THINKING ABOUT
ADDING TO THE FACT THAT THEY'RE
BEING WORN, THAT THEY'RE
COMPUTATIONAL DEVICES, THAT THEY
HAVE EMBEDDED DIGITAL
TECHNOLOGIES, KEY FEATURES OF
THESE TECHNOLOGIES ARE THAT
THEY'RE ALWAYS THERE, THEY'RE ON
THE PRESENT, THEY'RE
CONTINUOUSLY COLLECTING DATA,
THEY CAN TRANSMIT THAT DATA,
THEY CAN USE THAT DATA FOR
ANALYSIS, THEY CAN HAVE OTHER
FEATURES THAT RELATE TO BOTH,
YOU KNOW, IMPUTING THAT DATA FOR
PREDICTION AS WELL AS FOR
INTERVENTIONAL PURPOSES AND
TYPICALLY AND CERTAINLY MOST
COMMONLY RESEARCH CONTEXTS THESE
WEARABLES ARE TYPICALLY THIRD
PARTY CONSUMER ELECTRONICS,
ALTHOUGH SOMETIMES ALSO MEDICAL
DEVICES, AND I THINK THAT
THERE'S A REALLY IMPORTANT
DISTINCTION THAT WE'LL GET INTO.
SO I THOUGHT TO THINK ABOUT
WEARABLES REALLY DEEPLY AND
ETHICALLY ABOUT HOW WE'RE DOING
RESEARCH ON WEARABLES, I THOUGHT
WE COULD STEP BACK AND THINK
ABOUT, WHAT DOES IT MEAN REALLY
TO WEAR SOMETHING AND TO HAVE IT
ON YOURSELF?
THESE ARE THE STANDARD
DEFINITIONS, YOU KNOW, TO CARRY
OR TO HAVE ON ONE'S PERSON, I
THINK CRITICALLY AS A COVERING
SHES AN ADORNMENT OR AS
PROTECTION -- COVERING, AS AN
ADORNMENT OR AS PROTECTION.
SOMETHING TO BE CARRIED
HABITUALLY ON OUR PERSON, LIKE
WE WEAR GLASSES, AND SOMETHING
TO DISPLAY ON ONE'S APPEARANCE
AS IN TO WEAR A SMILE.
INTERESTINGLY IN REALLY THINKING
ABOUT THIS AND SOME OF THE
ETHICAL CHALLENGES INJURED LYING
RESEARCH AND ETHICS AROUND
WEARABLES, THERE'S ANOTHER
IMPORTANT NEENG THE WORD --
NEENG THE WORD TO WEAR, AND THAT
IS REALLY TO WEAR DOWN OR TO
ERODE AND I THINK THERE'S A
REALLY POWERFUL INTERPLAY
BETWEEN THESE CONCEPTS OF BOTH
ENHANCEMENT, PROTECTION, ALMOST
AS AN ARMOR, RIGHT, OUR SHOES
ARE A WEARABLE THAT PROTECT US
AS WE GO AROUND THE WORLD, AND
YET HOW WEARING ON SOMEBODY CAN
ALSO BREAK THEM DOWN AND CAN
TAKE AWAY AND BE A WAY OF SORT
OF SUBLGHTSLY AND OVER TIME --
SUBTLY AND OVER TIME DIMINISHING
CERTAIN FEATURES LIKE AUTONOMY
AND POWER.
SO TO FRAME OUR DISCUSSION, I
THINK THERE'S REALLY THREE KEY
TAXONOMIES OF WEARABLE DEVICES
IN A DIGITAL CONTEXT THAT I LIKE
TO THINK ABOUT.
THE FIRST ONE RELIES ON
LOCATION, LIKE LOCATION,
LOCATION, LOCATION, THAT'S THE
GPS TRACKER THAT'S IN ALL OF OUR
PHONES, WE MIGHT SAY WE'RE
WEARING IT NOW IF WE HAVE OUR
SMARTPHONES IN OUR POCKETS.
THESE ARE APPS, THEY COULD BE
ANKLE AND WRIST BRACELETS
TRADITIONALLY FOR KEEPING A PET
OR A PRISONER IN A CERTAIN
LOCATION, THOSE ARE WEARABLE
DEVICES, THEY CAN TRANSMIT
GEOLOCATION, TYPICALLY TO THIRD
PARTIES WHO MIGHT ENFORCE SOME
SORT OF PARAMETERS OR MIGHT USE
THAT INFORMATION ON INFORM HOW
THEY POLICE THAT PERSON'S
ACTIVITY H ANOTHER MAJOR
CATEGORY IS IN BIOMETRIC
SURVEILLANCE.
SO THESE ARE THE TECHNOLOGIES
HIGHLY ADVANCED ESPECIALLY OVER
THE PAST FIVE YEARS AND I THINK
WE CAN ANTICIPATE THE NEXT FIVE
YEARS AS OUR SENSOR TECHNOLOGY
ADVANCES.
THESE ARE CAPTURING BIOMETRIC
BIOLOGICAL DATA THAT CAN BE
ELECTRONIC, ELECTRIC DATA, LIKE
A HEART RATE, IT CAN ALSO BE
CHEMICAL AND CHEMICALLY SENSED
AND WHETHER THAT'S, YOU KNOW,
FROM THE SWEAT ON YOUR SKIN OR
FROM A SMALL AMOUNT OF BLOOD
THAT CAN JUST PROVIDE A CHEMO
SENSATION TO DETECT DIFFERENT
ANALITE SNRKS YOUR BLOOD, THESE
ARE BIOLOGICAL DATA ABOUT THAT
YOU'RE BEING SENSED.
THEN THERE'S THIS THIRD
CATEGORY, WHICH INCLUDES VIDEOS,
IMAGES AND AUDIO CAP CAPTURE,
RANGING FROM THINGS LIKE BODY
CAMERAS, THE SMART GLASSES LIKE
I WAS DESCRIBING MY BROTHER'S
COMPANY.
THESE ARE REALLY CAPTURING, I
WAS THINKING ABOUT THIS, HAD
IT'S NOT JUST SENSING YOU, BUT
SENSING WHAT YOU SENSE AND
SENSING YOUR BOTH BEHAVIORAL AND
SOCIOLOGICAL CONTEXT.
SO THESE ARE SORT OF THREE
DIFFERENT DIMENSIONS, AND OF
COURSE MANY DEVICES WILL SEEK TO
AND IN SOME WAYS COMBINE
DIFFERENT COMPONENTS ALONG THIS
SORT OF TAXONOMY, BUT I THINK
WHEN WE'RE CONSIDERING THE
ETHICAL IMPLICATIONS AS WELL AS
THE RISKS AND POTENTIAL BENEFITS
OF THESE TECHNOLOGIES, REALLY
THINKING ABOUT THEM ALONG THESE
THREE LINES CAN BE HELPFUL.
NOW, I SHOULD SAY BEFORE WE GET
INTO ANY MORE ETHICAL
CONSIDERATIONS AND CONCERNS
PERHAPS THAT I'LL RAISE, I THINK
IT'S VERY IMPORTANT TO RECOGNIZE
THE SUBSTANTIAL EXPANSION OF
WEARABLE TECHNOLOGIES OR SORT OF
DIGITALLY IMBUED WEARABLE
TECHNOLOGIES HA WE'RE ALREADY
EXPERIENCING AND THAT WE CAN
ANTICIPATE CONTINUING TO
EXPERIENCE.
SO FOR EXAMPLE, LAST YEAR, FOR
THE FIRST TIME, MORE
SMARTWATCHES WERE SOLD THAN
NONSMARTWATCHES.
AND IN FACT, APPLE SOLD MORE
WATCHES THAN ALL OF SWITZERLAND.
THIS IS REALLY TREMENDOUSLY
IMPACTFUL WHEN YOU THINK ABOUT
HOW THESE TECHNOLOGIES, WHEN
THEY'RE REALLY CRITICALLY WHEN
THEIR FORM FACTOR IS RIGHT AND
WHEN THEY'RE CULTURALLY
APPROPRIATED BY PEOPLE, HOW
RAPIDLY THEY CAN REALLY BE
ADOPTED, RIGHT?
SMARTWATCHES WERE NOT A NEW
THING LAST YEAR.
IT WAS JUST THE PAST COUPLE OF
YEARS THERE'S BEEN A TREMENDOUS
UPTICK IN THEIR ADOPTION AND
NORMALIZATION WHEN YOU GET
SOMETHING LIKE A WATCH THAT'S
BEEN AROUND FOR MANY, MANY YEARS
AND YOU IMBUE IT WITH NEW
TECHNOLOGIES THAT CAN BE
EMPOWERED BY SMALLER AND LIGHTER
BATTERIES AND MORE SORT OF
COMPUTING, YOU KNOW, THE ABILITY
TO DO PRETTY ADVANCED COMPUTING
IN A SMALL DISTRIBUTED DEVICE
HAS DRAMATICALLY CHANGED. SO
FOR THAT REASON, WE THINK ABOUT
THE IMPACT ON THE WATCH
INDUSTRY, RIGHT, MANY PEOPLE
DON'T WEAR WATCHES ANYMORE
BECAUSE WE DON'T NEED THEM TO
TELL TIME, AND INDEED, PEOPLE
WHO WEAR SMARTWATCHES OFTEN
AREN'T USING THEM TO TELL TIME.
THEY'RE USING THEM FOR THEIR
OTHER FUNCTIONALITY, FOR THE
DATA THAT THEY CAN GET FROM
THEM.
SO I KIND OF GO INTO THIS WHOLE,
YOU KNOW, CONTEXT OF THE
SMARTWATCH BECAUSE THESE DEVICES
ARE GOING TO BE MAJOR IN TERMS
OF THE NEXT TEN TO TWENTY YEARS
IN TERMS OF LIKE IF WE THINK
ABOUT ALL OF OUR WEARABLES, ALL
OF OUR TRADITIONAL WEARABLES
BECOMING SMART DEVICES OR HAVING
THE ABILITY TO BE SMART DEVICES,
THE IMPLICATIONS AND THE
SIGNIFICANCE OF BOTH WHAT WE CAN
LEARN AND THE POWER OF WHAT WE
CAN LEARN FROM THAT INFORMATION
TO HELP PEOPLE TO ADVANCE
RESEARCH, THIS IS REALLY
CRITICAL TOO.
SO WHILE WHEN YOU'RE PRESENTING
ON THE ETHICS AND THE
CHALLENGES, I THINK THAT THAT
CAN GET LOST, AND I THINK IT'S
REALLY CRITICAL THAT THEY WI --
THAT WE THINK ABOUT THE DESIGN
AND THE TECHNOLOGY ENABLEMENTS
OF WEARABLE TECHNOLOGY TO -- AS
A REALLY IMPORTANT OPPORTUNITY
AND ONE THAT'S NOT
UNCOMPLICATED, AND I THINK
CERTAINLY WHEN WE COMPARE TO
WHAT SOME PEOPLE WILL CALL AN
INSIDABLE, LIKE A BRAIN
IMPLANTED DEVICE, A WEARABLE,
WHICH HAS INHERENTLY MUCH LESS
FRICTION TO BE ADOPTED, HAS A
POTENTIAL FOR FAR GREATER AND
MORE SORT OF DISTRIBUTION AND
IMPLEMENTATION BECAUSE YOU DON'T
NEED A NEUROSURGERY TEAM AND A
NEUROLOGICAL TEAM, AND IT'S A
LOT EASIER TO APPLY THESE THINGS
AND IN FACT THAT'S PART OF THEIR
DESIGN.
SO THINKING ABOUT THE DESIGN OF
WEARABLES IS REALLY I THINK
WHERE THE ETHICS HAVE TO CENTER
ON THE DESIGN BECAUSE WEARABLES
ARE IN MANY WAYS DESIGNED TO BE
EASY TO APPLY WITH A FORM FACTOR
THAT MATCHES THE HUMAN BODY AND
OUR ERGONOMICS AND DYNAMICS OF
OUR MOVEMENTS, AND THEIR SUCCESS
IS REALLY PARALLELED WITH HOW
COMFORTABLY AND EASY WE CAN PUT
THEM ON, AND AT THE SAME TIME,
YOU KNOW, WHEN DONE WELL, THEY
RECEDE INTO THE BACKGROUND AND
YOU FORGET THAT THEY'RE THERE.
SO WHILE THE FRICTION TO SORT OF
ADOPT THEM MIGHT BE SOMEWHAT
LOW, WHEN THEY'RE DESIGNED
RIGHT, WE FORGET THAT WE'RE
WEARING THEM OR THEY JUST BECOME
IN MANY WAYS SIMILAR TO WHAT YOU
WOULD CONSIDER FOR AN IMPLANTED
DEVICE PART OF THAT PERSON AND
REALLY, YOU KNOW, I TAKE
SERIOUSLY MARSHA McCLUNE'S
ASSESSMENT THAT THESE
TECHNOLOGIES BECOME AN EXTENSION
OF OURSELVES, WHETHER THEY'RE
INSIDE OF OUR BODIES OR SIMPLY
APPLIED ON THE OUTSIDE OR
SOMEWHERE IN BETWEEN AS SOME OF
OUR, YOU KNOW, DEVICES IN THE
GYNECOLOGICAL SPACE MIGHT BE
CONSIDERED SO WE HAVE THESE
THREE TAXON MS. ON THE TYPES OF
DATA THAT ARE BEING COLLECTED
AND THERE'S THREE REALLY I THINK
KEY ETHICAL CONSIDERATIONS,
THEY'RE ALL WEAVING INTO ONE
ANOTHER AND THERE'S
CORRESPONDING DESIGN FEATURES WE
CAN THINK ABOUT TO FRAME THE
REST OF OUR CONVERSATION.
THE FIRST IS PRIVACY AND
AUTONOMY AND I THINK THIS IS
REALLY WHERE I WILL LEAD THE
CONVERSATION TOWARDS ANGD OF
WEARABLE DEVICES AS SORT OF
DECEPTIVELY INVASIVE.
AGAIN, BY DESIGN.
THEY'RE SEEMINGLY EASY TO PUT
ON, AND YET THEY SEEM LIKE
NONINVASIVE, CERTAINLY WHEN YOU
COMPARE THEM TO SOMETHING LIKE A
BRAIN SURGERY AND YET I THINK
THERE'S IMPORTANT WAYS IN WHICH
WE CAN CONSIDER THEM AS
POTENTIALLY MORE INVASIVE
DEPENDING ON WHAT KIND OF DATA
THEY'RE COLLECTING AND FOR HOW
LONG AND HOW THAT DATA MIGHT BE
USED.
SO THE WHOLE CONCEPT OF PRIVACY
AND AUTONOMY, ESPECIALLY WHEN
YOU CONSIDER HISTORICAL CONTEXT
OF WEARABLES BEING USED TO
CONTROL PEOPLE'S AUTONOMY, THIS
IS NOT ZUS A POLITICAL SENSE --
THIS IS NOT JUST IN A POLITICAL
SENSE BUT ALSO IN A PANDEMIC
SENSE OR IN A NUMBER OF OTHER
CONTEXTS, THE POTENTIAL FOR
THESE DEVICES TO ESSENTIALLY
INTRUDE ON IN THE BACKGROUND OF
ALL ACTIVITIES IS REALLY
SUBSTANTIAL.
THIS IS BY THEIR NATURE, AND
AGAIN, WHEN THEY'RE DESIGNED
RIGHT, THEY DO THIS REALLY WELL,
AND WE FORGET THAT THEY'RE
THERE.
IN FACT, ONE OF THE DOWNSIDES OF
SOME OF THE APPLICATIONS OF
THESE TECHNOLOGIES HAS BEEN IN
PEOPLE SIMPLY REMOVING THINGS OR
PERHAPS FOR GETTING THAT THEY,
YOU KNOW, IF THEIR SMARTPHONE IS
THE WEARABLE, IT'S EASY TO LEAVE
THAT ON A COUNTER AND WALK OUT
OF THE ROOM, AND THAT TELLS YOU
SOMETHING ABOUT WHAT WE CAN
ANTICIPATE WITH THE FUTURE OF
MOBILE COMPUTING DEVICES BEING
MORE TOWARDS WEARABLES AND LESS
TOWARDS THE KINDS OF THINGS THAT
YOU COULD LEAVE ON A COUNTER.
THEY WANT IT ON OUR BODIES AS
MUCH AS POSSIBLE TO, AGAIN,
MAXIMIZE THE POE TECIALG FOR
BENEFIT AND TO COLLECT --
POTENTIAL FOR BENEFIT AND TO
COLLECT DATA PASSIVELY AND AT
THE SAME TIME MAXIMIZING THE
INTRUSIVENESS AND THE SORT OF
POTENTIAL FOR INVASION INTO OUR
PRIVATE LIVES.
THE SECOND WHOLE CATEGORY I
CONSIDER EMBEDDED BIAS.
SO THIS IS A STRUCTURALLY BUILT
IN FEATURE THAT CAN BE BOTH ON
THE LEVEL OF A DEVICE ITSELF, AS
IN WHO IT WAS BUILT FOR, FOR
WHAT PURPOSE, AND WHO WAS PAYING
FOR THAT TO BE BUILT AND
IMPLEMENTED.
ALSO EMBEDDED IN THE PROCESS OF
HOW THESE TECHNOLOGIES ARE
VALIDATED.
SO TO THE EXTENT THAT THERE'S
SCIENCE BEHIND THEM, WHETHER
THEY ARE A MEDICAL DEVICE OR A
CONSUMER ELECTRONIC, THERE'S
SCIENCE BEHIND THESE DEVICES,
WHO WERE THEY TESTED ON?
WHOSE BENEFITS WERE THEY PROVEN
FOR?
WHOSE SAFETY WERE THEY PROVEN
FOR?
HOW EFFICACIOUS ARE THEY AND
CONSIDERATIONS AROUND BOTH THE
QUALITY OF THE EVIDENCE AND THE
REQUIREMENTS FOR, YOU KNOW,
WHAT'S EVIDENCE, TRULY
EVIDENCE-BASED ABOUT THESE
TECHNOLOGIES, AS WELL AS THEIR
SOCIOLOGICAL AND POTENTIALLY
POLITICAL CONSEQUENCES WHICH
ALSO MIGHT BURDEN PEOPLE IN A
NONEQUITABLY DISTRIBUTED MANNER.
SORT OF BUILDING ON THAT AND
EXTENDING INTO ANOTHER CATEGORY
OF REALLY POWER ASYMMETRY, BEING
AN ESSENTIAL ETHICAL CONCERN
THAT WE HAVE TO THINK ABOUT IN
THE DESIGN OF THESE DEVICES AS
WELL AS IN THE RESEARCH THAT WE
DO WITH THEM HAS TO DO WITH
POWER ASYMMETRY.
WHEN YOU'RE THE PERSON WEARING
THE DEVICE AND YOU'RE NOT THE
PERSON WHO OWNS THE DATA THAT
COMES FROM THAT DEVICE, THERE'S
A SIGNIFICANT DIFFERENCE IN
TERMS OF WHAT YOU'RE ABLE TO
GAIN AND WHAT YOU'RE ABLE TO --
WHAT BENEFITS YOU PROVIDE THOSE
WHO ARE OBTAINING THE DATA AND
WHAT BENEFITS YOU'RE RECEIVING
AND WHO HAS CONTROL OVER THAT
DATA, WHO HAS ACCESS TO THAT
DATA, ALL OF THESE THINGS ARE
SIGNIFICANT TO THE PRIOR
QUESTIONS AROUND WHO IS PAYING
FOR THESE DEVICES TO BE BUILT
AND IMPLEMENTED AND WHO IS
BENEFITING FROM THEM, BUT ALSO
REALLY SIGNIFICANT FOR, YOU
KNOW, LONG-TERM I THINK SOCIAL
JUSTICE IN TERMS OF THE IF YOU
THINK FULLY CIRCLE BACK TO THE
IDEA OF THESE DEVICES ARE REALLY
SOMETHING THAT WE CONSIDER TO BE
INVASIVE OR THAT WE CONSIDER A
DEEP SURVEILLANCE TECHNIQUE, THE
FACT THAT ALL OF THAT DATA FROM
OUR BODIES COULD BE TAKEN AND
FNT HAVE THE ABILITY TO CONTROL
OR EVEN REVIEW THAT BECOMES
SIGNIFICANT -- AND NOT HAVE THE
ABILITY TO CONTROL OR EVEN
REVIEW THAT BECOMES SIGNIFICANT
FOR US TO CONSIDER.
SO I'LL KIND OF WEAVE THOSE
DIFFERENT TOPICS THROUGH A
DIFFERENT CONCEPTS.
THE FIRST ONE IS THINKING ABOUT
WHERE DID THIS DEVICE COME FROM
AND WHO HAS PROVEN THAT IT'S
GOOD FOR WHAT?
THIS IS I THINK REALLY CRITICAL
WHEN WE THINK ABOUT RESEARCH
ETHICS BECAUSE THERE'S A LOT OF
RESEARCH THAT'S DONE ON DEVICES
THAT ARE CREATED IN THE CONSUMER
CONTEXT AND THEN BEING APPLIED
FOR PERHAPS USES OUTSIDE OF THE
CONSUMER CONTEXT, IN A MEDICAL
CONTEXT.
SO FOR EXAMPLE, A CONSTITUTED HE
WILL OF APPLE SMART -- A STUDY
OF APPLE SMARTPHONE USERS FOR
THE ABILITY TO DETECT THEIR
ATRIAL FIBRILLATION IS AN
EXAMPLE OF SORT OF MEDICAL
SCIENTISTS SAYING WAIT A SECOND,
THIS CONSUMER DEVICE HAS A
POTENTIAL SIGNIFICANCE FOR
CLINICAL UTILITY, AND APPLYING
THAT RESEARCH -- I KEEP HITTING
THIS THING, MY GESTURES.
I HAVE TO WATCH THE GESTURES.
APPLYING, SO THE SIGNIFICANCE OF
TAKING A TECHNOLOGY THAT WAS
SORT OF DESIGNED AND IMPLEMENTED
IN A COMMERCIAL CONTEXT AND THEN
REALLY APPROPRIATING IT FOR
ANOTHER USE, WHICH MAY BE VERY
APPROPRIATE AND HAS THE
POTENTIAL TO BENEFITED A LOT OF
PEOPLE, ALTHOUGH NOT ALL PEOPLE
EQUALLY, RIGHT, NOT EVERYBODY
HAS AN APPLE SMARTPHONE, NOT
EVERYBODY HAS A SMARTPHONE, SO
THAT'S SIGNIFICANT.
THERE'S ALSO VASTLY DIFFERENT
LEVELS OF REQUIREMENTS FOR THE
SCIENCE THAT GOES INTO, YOU
KNOW, USING A -- SORT OF PROVING
THAT AN APPLE PHONE CAN BE USED
AS A STEP TRACKER, AS OPPOSED TO
A GLUCOOM TER BEING USED FOR
TRACKING AND SAFELY MONITORING
SOMEBODY'S DIABETES.
SO A DEVICE THAT HAS FDA EVEN
CLEARANCE BUT FDA REVIEW HAS FAR
MORE, A LOT MORE COS ASSOCIATED
WITH IT, BECOMING APPROVED, AND
I THINK IMPORTANTLY WE SHOULDN'T
FORGET THAT WHETHER IT'S FDA
APPROVED OR CONSUMER ELECTRONIC,
IN BOTH CASES, THERE'S COMPANIES
THAT ARE INVESTED IN THE SORT OF
PROFIT MOTIVE RELATED TO THE
PRODUCTION AND PA APPROVAL OF
THESE DEVICES, SO DOESN'T SORT
OF ELIMINATE THAT DISPARITY, BUT
IT IS SIGNIFICANT TO CONSIDER
WHAT'S GETTING REVIEWED AND BY
WHOM, AS OPPOSED TO I THINK
TAKING ON FACE VALUE THE IDEA
THAT THESE TECHNOLOGIES ARE
EFFECTIVE, ESPECIALLY WHEN
THEY'RE BEING APPLIED OUTSIDE OF
THEIR ORIGINAL INTENT, BUT EVEN
FOR THEIR ORIGINAL PURPOSE.
AS I WAS PREPARING FOR THIS
LECTURE, SO MANY PEOPLE WERE
GIVING ME DIFFERENT EXAMPLES, I
THINK THE MOST PROFOUND ONE WAS
SOMEBODY WHO HAD A SLEEP TRACKER
THAT STARTED -- WAS REPORTING
HIM AS SLEEPING WHILE HE WAS
WATCHING A MOVIE.
AND IT WAS LIKE, THAT'S VERY
INTERESTING THAT A DEVICE, YOU
KNOW, IT WAS LIKE WHAT DATA WAS
IT EVEN USING TO DETERMINE THAT
YOU WERE ASLEEP, THAT IT COULD
MAKE SUCH A MISTAKE?
IT SEEMS LIKE THERE'S SUCH A
QUALITATIVE AND QUANTITATIVE
DIFFERENCE THAT ANY HUMAN BEING
WOULD BE ABLE TO TELL, THIS
PERSON IS SITTING ON THE COUCH
WATCHING A MOVIE, NOT SLEEPING
ON THE COUCH, YET IT'S AMAZE
THAT GO A TECHNOLOGY THAT'S MIT
SIENGS BACKED AND BLAH BLAH BLAH
WOULD BE ABLE TO SAY NO, YOU'VE
BEEN SLEEPING FOR THE LAST TWO
HOURS, SO MAYBE I SHOULD BE
GETTING UP MORE DUFERG THE
MOVE -- DURING THE MOVIE BUT
IT'S REALLY REMARKABLE WHEN YOU
CONSIDER THAT THE SAME EXACT
THINGS ARE APPLIED TO OXYGEN
MONITOR, YOU KNOW, OXYGEN
MONITOR SAYING THAT PEOPLE DON'T
HAVE CERTAIN OXYGEN SATURATION,
WHEN REALLY THEIR VALIDATION
HADN'T BEEN DONE SUFFICIENTLY IN
PEOPLE WITH THEIR SKIN COLOR.
RIGHT?
WE SORT OF TAKE THESE DEVICES AS
I THINK THERE'S A WAY IN WHICH
THEIR ADOPTION BECOMES SO
NATURAL THAT WE MAKE A LOT OF
ASSUMPTIONS ABOUT THEIR
EFFICACY, ESPECIALLY WHEN
THERE'S HARDWARE INVOLVED, AND
THAT THOSE ASSUMPTIONS ARE NOT
NECESSARILY VALIDATED, AND
AGAIN, WHEN YOU START TAKING
DEVICES, THIS WAS A COMMON ONE,
WAS TO TAKE ANY DEVICE THAT WAS
MEASURING PEOPLE'S TEMPERATURE
DURING THE PANDEMIC SUDDENLY
BECAME A DEVICE THAT COULD BE
COOPTED FOR PANDEMIC, YOU KNOW,
EITHER SURVEILLANCE CONTROL,
PREDICTION, AND THE COMMON
EXAMPLE THE ORAL DID RING -- AWP
TRACKING, ANOTHER ONE FOR
FERTILITY TRACKING, DEVICES
CREATED WITHOUT FDA APPROVAL FOR
CERTAIN PURPOSES AND NOW YOU'RE
APPLYING THEM TO THE CONTEXT OF
COVID AND SORT OF THE VAST
AMOUNT OF UNKNOWN ABOUT HOW
THESE TECHNOLOGIES ARE REALLY
FUNCTIONING, AND I THINK IT'S
CRITICAL AS IN, YOU KNOW, ANY
OTHER FIELD, BUT PERHAPS WITH
THESE DEVICES WHEN YOU HAVE
SOMETHING, IT COULD SORT OF SEEM
LIKE IT'S SORT OF A FACT OF HOW
IT'S GOING TO WORK.
AND I REALLY ENCOURAGE PEOPLE
WHO ARE DOING SCIENCE AND DOING
RESEARCH ON WEARABLES TO FIND
OUT WHAT DATA WENT INTO PROVING
THAT THIS DEVICE WORKS AT ALL.
WHAT STUDIES WERE DONE TO SHOW
THAT IT IS ACCURATE IN ANY WAY,
EVEN FOR ITS ORIGINAL INTENDED
PURPOSE, AND WHAT IS YOUR
EVIDENCE THAT WHILE VERY
REASONABLE IT TAKE SOMETHING
THAT'S MONITORING TEMPERATURE
AND IN FACT MANY PEOPLE THINK
ABOUT GOOD DESIGN IS DESIGN THAT
IS MADE FOR EMERGENTS, SO READY
FOR PEOPLE APPLYING IT IN NEW
WAYS, THAT'S NOT NECESSARILY A
BAD THING, BUT I THINK IT PUTS
YOU AT THE ONUS ON THE RESEARCH
COMMUNITY TO THINK, WELL, IF I'M
GOING TO START USING THIS FOR,
YOU KNOW, THE PROPOSED SORT OF
ALTERNATIVE USE OF TEMPERATURE
MONITORING IN THE PANDEMIC AS AN
EXAMPLE, HOW AM I VALIDATING
THAT THAT'S AN APPROPRIATE USE
AND NOT JUST SKIPPING OVER THAT
AND SAYING WELL IT'S USED FOR
TEMPERATURE MONITORING, SO WE'RE
GOING TO USE IT FOR MONITORING
TEMPERATURE IN THIS OTHER
CONTEXT.
SO THAT'S ONE WHOLE SET OF
CONSIDERATIONS.
I THINK THE OTHER THING THAT'S
SUPER IMPORTANT WHEN WE THINK
ABOUT THESE DEVICES AND THEIR
APPLICATION IN RESEARCH IS THAT
THERE'S A SORT OF POPULAR --
THERE'S A PROPENSITY FOR
CERTAINLY INVALIDATED IN POPULAR
SURVEYS THAT PEOPLE VIEW THAT
DATA ESPECIALLY WHEN THAT
RESEARCH IS BEING DONE AT A
RESEARCH CERTAIN, WHETHER IT'S
BY M DW'S OR Ph.D.'S OR
ANYBODY DOING RESEARCH THAT
THOSE DATA ARE PREKED BY SORT OF
SOME OF THE NORMS AND LEGAL
PROTECTIONS THAT WE ASSUME HA
PLY TO OUR HELIDATA, SORT OF AT
LARGE OR ELECTRONIC MEDICAL
RECORDS CERTAINLY.
AND THAT'S SIMPLY NOT TRUE IN
ALMOST ALL CASES, OR AT LEAST IN
A SUBSET OF CASES, EVEN FOR ANY
DEVICE, WHICH CAN BE QUITE
EASILY TRACKED TO GET THAT DATA
FROM, YOU KNOW, IF YOU RECEIVE
THE DEVICE FROM YOUR CLINICIAN
FOR EXAMPLE FOR A RESEARCH
STUDY, SORT OF SUBJECTS THAT
THAT DATA FROM THAT DEVICE WILL
RECEIVE THE SAME SORT OF RESPECT
AND LEGAL PROTECTION AS THAT
DATA WOULD BE IF IT WAS
OBTAINED, SAY, BY A BLOOD
PRESSURE MONITOR OR OTHER
SIMILAR TYPE DEVICES THAT ARE
APPLIED TO YOU WHEN YOU'RE IN
THE CLINICAL SETTING, NOW THAT
YOU'RE BEING MONITORED REMOTELY,
IS NOT NECESSARILY TRUE BECAUSE
OF THE THIRD PARTIES INVOLVED
AND BECAUSE OF OTHER SORT OF
GAPS IN OUR REGULATORY
INFRASTRUCTURE.
CRITICAL TO THINKING ABOUT
WEARABLES IS THE REALLY LIMITED
POTENTIALS OF INFORMED
CONSENTED.
SO THERE'S BEEN A LOT OF
RESEARCH THAT'S DEMONSTRATED THE
LIFETIMES ESSENTIALLY THAT IT
WOULD TAKE TO ACTUALLY READ ALL
OF THE PRIVACY POLICIES THAT ARE
GOING INTO ALL OF THESE DEVICES.
AS A PRACTICING CLINICIAN AND A
SURGEON, I COULD TELL YOU EVEN
IN THE CLINICAL CONTEXT, WE KNOW
THAT PEOPLE RNLT READING THESE
INFORMED CONSENT -- ARE NOT
READING THESE INFORMED CONSENT
FORMS AND ARE REALLY PUTTING A
LOT OF TRUST IN THE PEOPLE THAT
THEY'RE GETTING THESE DEVICES
FROM OR THE PEOPLE THAT ARE
DOING RESEARCH OR DOING CLINICAL
CARE TO HAVE THEIR BEST
INTERESTS AT HEART AND ARE IN
MIND.
AND I THINK THAT, YOU KNOW, SOME
OF THE CHALLENGES AROUND, YOU
KNOW, WHAT IS MEANINGFUL
INFORMED CONSENT FOR APPLYING A
DEVICE THAT YOU'RE GOING ON
FORGET THAT YOU'RE WEARING --
GOING ON FORGET THAT YOU'RE
WEARING, THAT YOU DON'T KNOW HOW
THAT DATA IS USED AND WE DOAN
KNOW WHAT WE MIGHT USE AT THAT
DATA FOR WHEN WE'RE GOING INTO
THAT RESEARCH, THERE'S SORT OF
AN INHEROIN, YOU KNOW, BROAD
APPLICATION OF BROAD CONSENT
WHERE, YOU KNOW, WE GET A TON OF
REALLY INTIMATE, VERY PARTICULAR
DATA FROM A PERSON, WHETHER IT'S
THEIR LOCATION, THEIR BODY,
THEIR SOCIOLOGICAL CONTEXT AND
BEHAVIORS, AND YET, YOU KNOW,
TREATING IT AS WHAT I THINK
ABOUT INFORMED CONSENT VIS-A-VIS
ACCEPTING COOKIES AND YEAH,
YEAH, GIVE ME THE FITBIT AND
I'LL PUT IT ON AND WE'LL KIND OF
TAKE IT FROM THERE CREATES SORT
OF AN INHERENT I THINK ONUS UPON
THE RESEARCH COMMUNITY TO NOT
JUST THINK ABOUT INFORMED
CONSENT AS ACHIEVED
PROSPECTIVELY BUT AS SOMETHING
THAT REQUIRES REALLY CONSENSUS
AND SORT OF ONGOING
COMMUNICATION ABOUT HOW THOSE
DEVICES ARE, IN FACT, BEING
USED, WHAT THAT DATA IS IN FACT
BEING USED FOR, REALLY CRITICAL
FOR SOME APPLICATIONS OF
WEARABLES, A GOOD EXAMPLE IS
FACEBOOK STORIES WHICH ARE THE
SMART GLASSES THAT HAD THE VIDEO
AUDIO CAMERAS AND THE IDEA, AND
THIS IS TRUE FOR OTHER SENSOR
TECHNOLOGY, WHEN A PERSON
CONSENTS TO WEAR OR PURCHASES
AND CONSENTS SORT OF IMPLICITLY
CONSENTS TO WEAR A DEVICE, THAT
DOESN'T MEAN THAT THE PEOPLE
AROUND THEM DID, AND IT'S AN
INTERESTING PARALLEL TO WHAT WE
TALK ABOUT IN TERMS OF CONSENT
FOR GENETICS, WHERE YOU THINK
ABOUT THIS IS THE KIND OF THING
THAT YOU COULD CONSENT FOR BUT
YOUR WHOLE FAMILY'S GENETICS
COULD BE REVEALED BY THAT
DECISION, THIS SAME THING IS
TRUE IN A FAR GREATER FIELD OF
SORT OF, YOU KNOW, COLLATERAL
PARTIES OR THIRD PARTIES WHO
BECAUSE OF THE SENSING DEVICES
I'M WEARING, NOW ALL OF YOU ARE
ALSO BEING MONITORED.
SO SORT OF THE BURDENS AROUND
AND SOME OF OUR NORMS AROUND
INFORMED CONSENT REALLY DON'T
APPLY IN THIS CONTEXT, SO I
THINK SOME OF OUR DUTIES AROUND
ENSURING THE SAFETY, PROTECTION,
BOTH THE PRIVACY OF THAT DATA AS
WELL AS THE BENEFITS TO THOSE
INDIVIDUALS WHO MIGHT BE
AFFECTED BEYOND EVEN THE
INDIVIDUAL IN OUR STUDIES IS
REALLY CRITICAL.
SO I THINK THIS IS WEAR SOME OF
OUR OPPORTUNITIES LIE IN TERMS
OF WEARABLE RESEARCH AS
SOMETHING WHERE THE ABILITY TO
CONFER TO THAT INDIVIDUAL THE
BENEFITS OF PARTICIPATING IN
THAT RESEARCH BECOMES AN
OPPORTUNITY THAT WILL OFFSET
SOME OF THE RISKS THAT WE
ESSENTIALLY THAN THEY MAY BE
UN-- KNOW THAT THEY MAY BE
UNWILLINGLY TAKING ON ESPECIALLY
IF THEY DON'T FULLY APPRECIATE
THE SIGNIFICANCE OF WHAT THE
DATA COMING FROM THEM FROM THESE
DEVICES WILL BE ABLE TO DO AND
HOW IT MIGHT AFFECT THEM
PRESIDENT FUTURE.
-- AND HOW IT MIGHT AFFECT THEM
IN THE FUTURE.
SO WE KIND OF TOUCHED ON THE
IMPACT ON DISPARITIES AND
DISCRIMINATION ALREADY.
I THINK THE REALLY IMPORTANT
EXAMPLES TO KEEP IN MIND ARE
ONES, AGAIN, GOING BACK TO THE
TEMPERATURE SENSING, ESPECIALLY
GIVEN THE GENETIC DIFFERENCES
AND PHYSIOLOGIC DIFFERENCES
BETWEEN MEN AND WOMEN, AS AN
EXAMPLE.
RIGHT?
WE'RE APPLYING A DEVICE THAT'S
MEANT FOR SLEEP TRACKING, MAYBE
TESTED IN A LARGELY MALE
POPULATION, NOW WE'RE TESTING IT
FR APPLICATION FOR WHETHER
PEOPLE CAN GO TO WORK DURING THE
COVID PANDEMIC.
WELL, IF PEOPLE HADN'T STOPPED
TO CONSIDER THAT WOMEN'S
TEMPERATURE NATURALLY FLUCTUATES
OVER THE COURSE OF A MONTHLY
CYCLE, THEY COULD SORT OF BE
INADVERTENT AM SEQUESTERED --
INADVERTENTLY SEQUESTERED OR
BASED ON THE FINDINGS, OH, YOUR
TEMPERATURE IS TRENDING UP, THAT
MEANS YOU SHOULD STAY HOME FROM
WORK TODAY, MAYBE THAT WAS A
PHYSIOLOGIC PROCESS THAT WASN'T
REALLY CAPTURED IN THE DESIGN OF
THE DWIERKS A GOOD EXAMPLE OF
HOW THESE COULD BE AIF HE
CANNING PEOPLE DIFFERENTLY.
IT BECOMES MORE SIGNIFICANT WHEN
YOU THINK ABOUT ALL OF THE
REPRODUCTIVE JUSTICE OR
REPRODUCTIVE INJUSTICE CONTEXT
AND HOW BOTH PRIVATE AND PUBLIC
ENTITIES CAN BE COOPTED FOR THE
PURPOSES OF IMPLEMENTING VARIOUS
KINDS OF STATE CONTROL OVER
ACCESS TO REPRODUCTIVE SERVICES
OR DEMONSTRATING WHO MIGHT HAVE
HAD A MISCARRIAGE OR WHO MIGHT
HAVE HAD AN ABORTION JUST BASED
ON THEIR TEMPERATURE ALONE, AND
IT'S SOMETHING THAT WE SHOULD BE
THINKING ABOUT, LIKE REALLY
NONBENIGN USES OF THESE
TECHNOLOGIES THAT WE'RE SEEM --
THAT WERE SEEMINGLY OFF THE
SHELF IN BEST BUY AS SOMETHING
YOU CAN BUY AND SUDDENLY THERE'S
A COMPANY WHO COULD HAVE THAT A
STATE MIGHT HAVE AN INTEREST IN
FIENG OUT ABOUT.
THIS -- FINDING OUT ABOUT.
THIS HAS HISTORICALLY BEEN TRUE
IN POLITICAL ACTIVITY,
GEOLOCATION, IN AREAS LIKE
TAIWAN SPHRAMPLE A PLACE WHERE
PEOPLE REALLY EXPERIENCED THE
HARMS OF THEIR DEVICES REGARDING
WHERE THEY ARE WITH REGARD TO
POLITICAL ACTIVITIES.
AND AGAIN, THE QUESTION WHEN
YOU'RE THINKING ABOUT DOING
RESEARCH ON WEARABLES, AHA,
THERE'S ALL OF THESE PEOPLE THAT
ARE ALREADY WEARING WEARABLES,
WHY DON'T WE STUDY THEM BECAUSE
IT'S AGAIN THE FRICTION TO
IMPLEMENT IT AND IN SOME CASES
THE NEED TO DO ADDITIONAL
INFORMED CONSENT MIGHT SIMPLY BE
ELIMINATED BY A MINIMAL RISK
RESEARCH DESIGN.
AT THE SAME TIME, WHO HAS THOSE
DEVICES ALREADY AND WHAT ARE WE
GOING TO LEARN, WHO ARE WE GOING
TO BE BENEFITING, WHO ARE WE
GOING TO BE AIF HE CAN BIG THAT
RESEARCH THAT MIGHT NOT BE
EQUITABLY DISTRIBUTED?
AGAIN, IF YOU'RE THINKING ABOUT
LIKE AN APPLE DEVICE OR WE'RE
GOING TO DO A STUDY ON PEOPLE
WHO ALREADY HAVE FIT BITS, AS
OPPOSED TO A STUDY THAT PROVIDES
THEM AS PART OF THE RESEARCH.
AGAIN, THAT DISENLTDZ MEAN THAT
THIS SECOND WAY -- THAT DOESN'T
MEAN THAT THIS SECOND WAY IS
NECESSARILY BETTER, IT COMES
WITH DIFFERENT RISKS AND
BENEFITS AND JUST PART OF THE
CONSIDERATION.
AND SORT OF THE LAST SORT OF
MAJOR THEME I'LL HIGHLIGHT IS
ABOUT, YOU KNOW, WHO OWNS THE
DATA THAT COMES FROM THESE
DEVICES?
WHO OWNS THE INFORMATION ABOUT
WHERE YOU WERE, WHAT YOU WERE
DOING, HOW YOU WERE FEELING,
WHAT YOU WERE SAYING, THINKING,
WHO YOU WERE WITH?
WHO OWNS THAT DATA?
BECAUSE IN THE CURRENT
REGULATORY FRAMEWORKS AND THE
CURRENT WAY THAT THESE DEVICES
ARE ADMINISTERED, IT'S LARGELY
NOT THE INDIVIDUAL.
AND IN FACT, IN MANY CASES, THE
INDIVIDUAL MAY NOT EVEN HAVE
ACCESS FULLY TO THE BREADTH OF
THAT DATA, IN PARTICULAR FOR
THEMSELVES, MUCH LESS THE
CONTEXT OF THE AGGREGATE DATA
THAT WOULD BE REQUIRED TO FULLY
MAKE SENSE OR MEANING OUT OF
THAT DATA AND TO MAKE IT AT
LEAST POTENTIALLY USEFUL TO THAT
INDIVIDUAL.
SO I THINK CRITICALLY THINKING
ABOUT IN A RESEARCH DESIGN OF
WHO OWNS THE DATA, WHO IS GOING
TO PROFIT FROM THIS, WHO IS SORT
OF -- WHOSE SORT OF INTENTIONS
ARE GOING TO BE EITHER VALIDATED
OR POTENTIALLY CRICTSDZ VIA THE
RESEARCH YOU'RE DOING --
CONTRADICTED VIA THE RESEARCH
YOU'RE DOING WITH THESE DEVICES
AND WHO IS GOING TO BE INTIRVED
THAT, BOTH IN THE CONTEXT OF THD
THAT, BOTH IN THE CONTEXT OF THE
STUDY AND IN THE LONG TERM ARE
THINGS TO THINK ABOUT.
AS INDIVIDUAL RESEARCHERS, YOU
KNOW, WE TEND ON THINK ABOUT
IT'S VERY TRADITIONAL RESEARCH
ETHICS IS VERY LIKE THE
INDIVIDUAL RESEARCHER AND LIKE
YOU'RE PROVIDING A CERTAIN
AMOUNT OF THINGS ON THIS PERSON,
BUT IN ADDITION TO US AS
INDIVIDUALS, WE HAVE TO THINK
ABOUT OUR EMPLOYERS AND WHAT
THEY OWN AS A RESULT OR WHAT THE
COMPANIES WHOSE DEVICES WE'RE
USING OR IF THEY'RE PROVIDING
THEM AS A LOAN, RIGHT, AS YOU
MIGHT THINK ABOUT SOME OF THE
ELECTRONICS THAT YOU IMPLANT
SOMETIMES ARE PROVIDED A LOANER
BASIS, SOMETIMES A WEARABLE IS
PROVIDED ON A LOANER BASIS, WHO
REALLY SORT OF OWNS THAT FOR THE
TIME THAT THE PERSON IS WEARING
IT?
WHO OWNS THAT INFORMATION AND,
YOU KNOW, THE GOOD THING I GUESS
WE TALK ABOUT IN SOME OF THE
FUTURE DIRECTIONS IS THE
POTENTIAL FOR SORT OF NEW
TECHNOLOGIES AND NEW STRUCTURES
AND NEW THINKING AROUND HOW
THESE DEVICES ARE DESIGNED, HOW
THE RESEARCH AROUND THEM IS
DESIGNED THAT CAN GIVES
OPPORTUNITIES TO MAYBE DESIGN
FOR SORT OF MORE ETHICALLY
EMBEDDED RESEARCH.
THIS I THOUGHT WAS A GREAT JUST
IMAGE FROM AN ARTICLE ABOUT
CONSUMER WEARABLES IN PARTICULAR
BECAUSE IT SHOWS HOW SORT OF OUR
MENTAL MODEL IS REALLY HERE, YOU
KNOW, ON THE LEFT OF WHAT'S
INVOLVED IN THE RESEARCH AND IS
SWERNL A CONSUMER WEARABLE --
CERTAINLY WITH A CONSUMER
WEARABLE, YOU HAVE THE RESEARCH
AND YOU HAVE THE PARTICIPANTS
BUT THEN YOU HAVE ALL THESE
OTHER THIRD PARTIES AND ALL
THESE THIRD PARTY ACTIVITIES
GOING ON OVER HERE, UPON WHICH
THE RESEARCHER RELIES TO GET THE
DATA THEY NEED FOR THEIR END BUT
THAT IT'S NOT SORT OF A CLOTHED
SYSTEM -- CLOSED SYSTEM AND SORT
OF THE STAKES AT HAND ARE JUST
FAR MORE WIDESPREAD, AND I THINK
AGAIN INHERENTLY HIDDEN.
SO SOME FUTURE DIRECTIONS, AND
HOW ARE WE DOING ON TIME?
>> SO YOU'RE DOING GREAT.
TENNESSEE FOR YOUR LECTURE, THEN
WE'LL HAVE TEN MINUTES FOR
DISCUSSION.
>> OKAY, GREAT.
PERFECT.
I'LL HIGHLIGHT SOME POTENTIAL
TECHNOLOGY SOLUTIONS.
REALLY THIS IS JUST TO KIND OF
INTRODUCE THESE SOLUTION AREAS
THAT HAVE THE POTENTIAL TO HAVE
SIGNIFICANCE FOR SOME OF THE
CHALLENGES THAT WE WERE TALKING
ABOUT.
SO THE FIRST IS BLOCKCHAIN
TECHNOLOGY.
FOR THOSE WHO MAY NOT BE
FAMILIAR WITH IT, THE MOST
FAMOUS EXAMPLE IS BITCOIN.
THE FUNDAMENTAL PRINCIPLE BEHIND
BLOCKCHAIN TECHNOLOGY IS A
DISTRIBUTED LEDGER, WHERE
EVERYBODY HAS ACCESS TO THE SAME
SET OF THE DATA ON THEIR OWN
SORT OF IN A LOCAL CONTEXT, SO
THE SORT OF SHARED VERSION OF
THE TRUTH IS SORT OF UNDERLYING
PRINCIPLE FOR A BLOCKCHAIN
TECHNOLOGY.
SO WHEN YOU THINK ABOUT IT IN
TERMS OF A WEARABLE, HOW THIS
MIGHT BE SIGNIFICANT, IF
EVERYBODY WHO IS, SAY, WEARING
THE WEARABLES IN YOUR STUDY HAD
ACCESS TO THEIR DATA AS WELL AS
ALL OF THE DATA THAT YOU WERE
COLLECTING FOR THE STUDY AND
WERE ABLE TO ACTUALLY BE
INCLUDED IN THE, AT LEAST AS
PEOPLE WHO HAD ACCESS TO AND THE
ABILITY TO ANALYZE AND INTERPRET
FOR THEMSELVES THAT RESEARCH
DATA CREATES AN OPPORTUNITY ON
THINK ABOUT REALLY THE STRUCTURE
OF YOUR DATA ARCHITECTURE AS ONE
THAT'S INHERENTLY INCLUSIVE AND
INHERENTLY, YOU KNOW, HAS BUILT
IN MECHANISMS FOR ENFORCING
TRUST FOR PROVE ABILITY, RIGHT,
SOIT NOT JUST THE COMPANY -- SO
IT'S NOT JUST THE COMPANY WHO
MADE THE DEVICES, THE ONE WHO
GETS DATASET AND GETS TO ANALYZE
IT AND GETS TO TELL THE WORLD
ABOUT WHAT THEY FOUND, IT ALSO
CREATES MECHANISMS TO ENFORCE
NOT ABILITY FOR THOSE RESEARCH
FINDINGS AND FOR REALLY JUST
SHARING THE ACCESS TO THE
INFORMATION IN A WAY THAT
DEMOCRATIZES IT FUNDAMENTALLY.
THERE'S A WHOLE SORT OF CULTURAL
MOVEMENT AROUND BLOCKCHAIN
TECHNOLOGY TYPICALLY CALLED WEB
3 MOVEMENT WHICH REALLY HAS AT
ITS FUNDAMENTAL CORE THE IDEA
THAT THE OWNERSHIP OF THE WEB OR
THE OWNERSHIP OF THE DIGITAL
SPACE NEEDS TO BE DEMOCRATIZED
FOR THE FUTURE OF DEMOCRACY TO
BE REAL AND TO BE MAINTAINED,
WHEREAS WE THINK ABOUT ALL OF
OUR SOCIAL AND POLITICAL
ORGANIZATIONS IN THE PHYSICAL
WORMED THAT HAVE CERTAIN
PRINCIPLES EMBEDDED IN THEM AND
CERTAIN DEMOCRATIZED OWNERSHIP
OVER LIKE OUR BODIES, AND ARE
YET WHEN YOU GO INTO THE DPIJ
TAL SPACE, MANY PEOPLE --
DIGITAL SPACE, MANY PEOPLE WILL
THINK OF IT WHERE THERE'S THESE
LARGE AGGREGATORS THAT LARGE THE
DATA IN A WAY THAT GIVES THEM
INESCAPABLE ADVANTAGE OVER
POTENTIAL COMPETITORS TO THEM,
MUCH LESS TO THE INDIVIDUALS WHO
THEY'RE SERVING.
OKAY.
SO THOSE ARE SOME OF THE IDEAS
AROUND THERE.
ZERO KNOWLEDGE PROOFS IS AN
IMPORTANT AND NOW REALLY
STARTING TO TAKE OFF TECHNOLOGY,
WHERE YOU CAN PROVE
INFORMATION ABOUT A DATASET
WITHOUT GETTING ACCESS TO THAT
DATASET, SO THE REALLY CRITICAL
FEATURE UNDERLYING
ZERO-KNOWLEDGE PROOF TECHNOLOGY
IS THAT I CAN KEEP MY DATA
PRIVATE FROM YOU AND YOU CAN
STILL DO ANALYSIS THAT
DEMONSTRATES WHETHER OR NOT
CERTAIN CRITERIA LIKE IF A OR B
IS CORRECT, YOU CAN FIND OUT
THAT ANSWER IN A PROVEABLE
MATHEMATICALLY PROVEABLE WAY
WITHOUT ME EVER SHOWING YOU MY
DATA, SO THE FACT THAT THOSE
KINDS OF SORT OF ALGORITHMIC
PROOFS ARE POSSIBLE WITHOUT
SHARING DATA CREATES REALLY
IMPORTANT OPPORTUNITIES IN THE
SPACE OF WEARABLES WHERE WE
MIGHT HAVE REALLY IMPORTANT
REASONS TO KEEP OUR DATA LOCAL
TO THE DEVICE AND KEEP IT SORT
OF FUNDAMENTALLY DISTRIBUTED,
AGAIN, WHETHER IT'S WITH A
BLOCKCHAIN OR NOT, THAT DATA CAN
REMAIN LOCAL TO THE DEVICE,
DOESN'T HAVE TO BE SHARED WITH
THE COMPANY OR SHARED EVEN WITH
THE RESEARCHER FOR THEM TO BE
ABLE TO LEARN FROM IT.
ANOTHER CATEGORY OF PRIVACY
PRESERVING TECHNOLOGIES RELEVANT
HERE, TRUSTED EXECUTION
ENVIRONMENTS, ALREADY BEING
IMPLEMENTED IN SOME WEARABLE
CONTEXT, THOSE INTERESTED IN
WEARABLE RESEARCH THIS IS A
REALLY IMPORTANT AND GROWING
OPPORTUNITY, ESSENTIALLY IT'S
HARDWARE THAT FUNCTIONS LIKE A
BLACK BOX BUT ON THE LEVEL OF
THE INDIVIDUAL.
SO PEOPLE CAN PUT THEIR DATA IN.
OTHER PEOPLE CAN'T NECESSARILY
SEE IT.
SO IT DOES SORT OF LENDS ITSELF
TO MAINTAIN BEING PRIVACY OF
IDENTITY AS WELL AS WHILE AT THE
SAME TIME CREATING THAT DATA AND
ALLOWING THAT DATA TO BE USEFUL
FOR DIFFERENT LEARNING
FUNCTIONS.
AND A FOURTH CATEGORY WHICH IS
PROBABLY THE, YOU KNOW, AT LEAST
AS DEVELOPED IF NOT MORE
DEVELOPED I WOULD SAY THAN
BLOCKCHAIN TOMG AT THIS POINT IS
A FED -- TECHNOLOGY AT THIS
POINT A FEDERATED APPROACH TO
LEARNING, ALTERNATE IS SPLIT
LEARNING APPROACH, WHERE
ESSENTIALLY YOU CAN SEND AN
ALGORITHM TO SOMEBODY'S DEVICE,
THAT COMPUTATION CAN BE DONE
LOCALLY, THE MOST COMMON EXAMPLE
OF THIS IS HOW AUTO CORRECT
WORKS ON OUR TEXT MESSAGES, SO
IT HAPPENS SO FAST, THAT'S
HAPPENING FAST BECAUSE THE
COMPUTATION IS HAPPENING ON YOUR
DEVICE AND YOUR TEXT MESSAGES
NEVER LEAVE THE DEVICE.
SO THAT'S AN EXAMPLE OF HOW WE
CAN THINK ABOUT THE DATA AS BEIR
EMBEDDING A SORT OF ETHICAL
PRINCIPLES IN THE DESIGN OF HOW
WE IMPLY MEN THESE TECHNOLOGIES.
THE FINAL POINT IS REALLY SORT
OF TAKING THE TECHNOLOGICAL
IMPLEMENTATION, ONE CATEGORY OF
WAYS WE CAN COMBAT SOME OF THESE
CHALLENGES IS IN THE TECHNOLOGY
ITSELF, IN THE DESIGN ITSELF, IN
THE DESIGN OF OUR STUDIES IS THE
OTHER WAY.
SO IN THE DESIGN OF HOW WE
INCLUDE AND SHARE GOVERNANCE FOR
THESE TECHNOLOGIES WITH THE
PEOPLE WHO WE'RE STUDYING.
SO HOW YOU MIGHT INCLUDE PEOPLE
IN THE CONVERSATIONS NOT JUST
DURING INFORMED CONSENT, BUT
REGULARLY THROUGHOUT THE
CONTEXT.
ONE OF THE THINGS THAT WEARABLES
ALLOWS YOU TO DO IS STUDY PEOPLE
THAT ARE VERY, VERY FAR AWAY
FROM YOU, WITHOUT EVEN PERHAPS
OBSERVING A PERSON WEARING THE
DEVICE THAT YOU'RE GETTING DATA
FROM.
SO I ENCOURAGE PEOPLE WHO ARE
STUDYING, YOU KNOW, STUDYING
WEARABLE DATA TO OBSERVE PEOPLE
IN THEIR NATURAL HABITAT, IF YOU
WILL, AND SEE HOW THESE DEVICES
ARE REALLY AFFECTING PEOPLE,
GIVE PEOPLE ALSO THE SORT OF
POWER, PART OF THIS IS THE SCARY
THING FOR RESEARCHERS IS IF
YOU'RE GOING TO SAY WE'RE GOING
TO DISTRIBUTE POWER, WE'RE GOING
ON GIVE A SAY IN HOW NOT JUST
WHAT WE THOUGHT WAS GOING TO
HAPPEN THE IN BEGINNING OF THE
RESEARCH, BUT WE'RE GOING TO
GIVE YOU A SAY IN HOW THINGS ARE
GOING AND THE ABILITY CRITICALLY
TO OPT OUT, TO WITHDRAW, TO
CHANGE THINGS BASED ON WHAT ENDS
UP HAPPENING REQUIRES BOTH
DISTRIBUTION OF AND TRANSPARENCY
ABOUT HOW THE RESEARCH IS GOING,
WHAT WE'RE LEARNING, WHAT WE'RE
FINDING, WHAT WE'RE DOING WITH
IT, BUT ALSO OF THE POWER TO
DIRECT CHANGES AND FOR PEOPLE
WHO ARE WEARING THE DEVICES OR
PART OF THE RESEARCH TO EFFECT
SORT OF THE DIRECTION OF THE
RESEARCH, WHICH REQUIRES REALLY
LIKE A LOT OF TRUST BOTH IN THE
RESEARCH COMMUNITY AND PLANS
REALLY FOR HOW YOU'RE GOING TO
DO THINGS DIFFERENTLY IF THE
RESEARCH PARTICIPANTS DECIDE
THAT THEY DIDN'T LIKE THE WAY
THAT THE RESEARCH WAS GOING OR
THEY DIDN'T LIKE THE CONCLUSIONS
OR, YOU KNOW, THE CONTENT ABOUT
THEM THAT YOU WERE PUBLISHING.
SO IN ORDER FOR THEM TO EVEN BE
ABLE TO REVIEW THAT, THEY HAVE
TO BE ABLE TO SEE THAT THAT DATA
AND HAVE TRANSPARENCY ABOUT
THAT.
SPROIF MY LAST THREE TAKE AWAYS
HERE, ONE, I HOPE TO HAVE AT
LEAST CONVINCED YOU OR TO
CONSIDER WEARABLES AS REALLY A
TRULY INVASIVE METHODOLOGY GIVEN
THE AMOUNT OF DATA THAT THEY CAN
COLLECT AND GIVEN THE AMOUNT OF
ALMOST THIS PARASITIC NATURE OF
HOW THEY CAN ABSORB THINGS AND
HOW THEY CAN REALLY, HOW THEY'RE
TAKING FROM PEOPLE IN A WAY THAT
I THINK IT MAY BE VERY EASY TO
FORGET AND THAT THEY RELY ON
TRUST.
THE SECOND IS TO THINK ABOUT,
YOU KNOW, CHALLENGE YOUR
ASSUMPTIONS, ESPECIALLY WHEN
YOU'RE USING CONSUMER DEVICES,
BUT I'M ALMOST EQUALLY
SIGNIFICANT I THINK FOR MEDICAL
DEVICES, BUT CHALLENGE YOUR
ASSUMPTIONS ABOUT THE
APPLICABILITY AND VALIDITY OF
THE USE OF THOSE MATERIALS FOR
YOUR INTENDED PURPOSE BECAUSE IF
YOU DIG INTO THE DATA, YOU WANT
TO BE SURE THAT YOU'RE STANDING
ON SOLID GROUND FROM WHERE YOU
WORK, AND IT'S JUST CERTAINLY
NOT GUARANTEED.
AND THE LAST IS THAT, YOU KNOW,
THERE ARE POWER ASYMMETRIES
STRUCTURALLY BUILT INTO HOW
PEOPLE, YOU KNOW WHORKS GETS TO
ACCESS THAT -- WHO GETS TO
ACCESS THAT DATA AND WHO GETS TO
COMMERCIALIZE IT AND WHO GETS TO
HAVE CONTROL OVER IT AND WHEN
IT'S THAT REALLY INTIMATE DATA,
THERE ARE ALSO OPPORTUNITIES
BOTH TECHNOLOGICALLY AND IN YOUR
RESEARCH DESIGNS THAT INCLUDE
PARTICIPANTS, THAT PROTECT THEIR
INTERESTS FROM PRIVACY AND
AUTONOMY STANDPOINT.
SO I'LL LEAVE IT AT THAT, AND I
LOOK FORWARD TO YOUR QUESTIONS.
[APPLAUSE]
I'LL TRY TO STOP HITTING THESE.
>> THANK YOU SO MUCH.
SO AS YOU PROBABLY SAW WITH
SASKIA'S LECTURE, WE HAVE FOLK
IN THE ROOM WHO CAN GO TO THE
MIC TO ASK QUESTIONS, AND I ALSO
HAVE SOME QUESTIONS FROM OUR
VIRTUAL AUDIENCE.
SO AS YOU ALL RUSH TO THE MICS,
HERE IS A QUESTION FROM LAURA.
SHE SAYS, I'M INTERESTED IN THE
SPEAKER'S TAKE ON THE RISKS
ASSOCIATED WITH POTENTIALLY
CONFLICTING PRIORITIES OF
CONSUMER DEVICES.
FOR EXAMPLE, HEALTH VERSUS
MARKETABILITY, PROFITABILITY,
AND WHETHER SUCH CONFLICTING
PRIORITIES MAY RESULT IN
REDUCING HEALTH.
SO ADS FOR FAST FOOD LOCATIONS
OR HELIACTIVITIES THAT AREN'T
EVIDENCE-BASED OR REDUCING
AUTONOMY VIA PSYCHOLOGICAL
MANIPULATION H.
>> YEAH, I THINK THAT'S A REALLY
GREAT QUESTION.
I THINK ONE GOOD EXAMPLE OF THIS
THAT I THINK ABOUT IS WITH SLEEP
TRACKING.
RIGHT?
OKAY.
ASSUME THAT THE SLEEP TRACKER IS
WORKING.
PROVE THAT YOU'VE ACTUALLY
IMPROVED PEOPLE'S SLEEP AS A
RESULT OF THEIR USE OF THOSE
DEVICES, BECAUSE MANY PEOPLE WHO
USE DEVICES FOR TRACKING
PURPOSES EXPERIENCE BENEFITS,
MANY PEOPLE EXPERIENCE HARMS,
AND THAT REALLY ONLY COMES OUT
WITH RESEARCH OVER TIME, WHICH
IS WHY RESEARCH ON THESE
DEVICES, EVEN IF THEY'RE ALREADY
IMPLEMENTED, IS SO CRITICAL,
LIKE WE NEED THAT LONG-TERM SORT
OF LIKE ALL THE WAYS THAT PEOPLE
ARE ACTUALLY USING THESE
DEVICES, WE NEED TO STUDY THAT.
IS IT ACTUALLY MAKING THEM
HEALTHIER OR IS IT
PSYCHOLOGICALLY OR PHYSICALLY
TOXIC IN SOME WAY AND REALLY ON
EVERY LEVEL?
SO I DON'T KNOW IF THAT AN PS
THE QUESTION -- IF THAT ANSWER
PS THE QUESTION, BUT I THINK
THAT IT'S AN OPEN QUESTION AND
IT'S GOING ON VARY CASE BY CASE
AS TO WHETHER A PROPOSED BENEFIT
IS, IN FACT, BEING ACCRUED TO
PEOPLE AND ESPECIALLY WHEN
DEVICES ARE NOT FDA, YOU KNOW,
THROUGH THE FDA PROCESS, THERE'S
NO POST-MARKET ANALYSIS.
BASICALLY IT SELLS OR IT
DOESN'T.
RIGHT?
THE MARKET DECIDES.
WHICH IS QUITE DIFFERENT THAN IT
BEING HEALTHY OR NOT.
>> YEAH, AND IT BRINGS UP SOME
OF THE ISSUES THAT SASKIA
BROUGHT UP INTHERMS OF THE SORT
OF WHAT ARE, IF ANY OF THE
RESEARCHERS' OBLIGATIONS TO
CARRY ON THAT SORT OF LONG-TERM
DATA COLLECTION TO SEE HOW WHAT
MIGHT HAVE BEEN, YOU KNOW,
INTERESTING IN THE CONTEXT
OFFING -- I'M GETTING SOME
FEEDBACK, I'LL MOVE BACK THIS
WAY -- INTERESTING FINDINGS THAT
YOU MIGHT COLLECT AS A RESULT OF
A RESEARCH PHASE THAT IF THE
PERSON CONTINUES TO USE THAT
APP, ARE THERE LONG-TERM DOWN
SIDES TO DOING SO, AND WE WON'T
KNOW IF THERE ISN'T ANY
LONG-TERM FOLLOW-UP OF THOSE
INDIVIDUALS.
>> THERE'S A GROWING MOVEMENT TO
START CONSIDERING SOME OF THESE
APPLICATIONS AND WEARABLES AGAIN
TEND TO HAVE A PHYSICAL HARDWARE
COMPONENT AS WELL AS A SOFTWARE
COMPONENT BUT THERE'S A GROWING
MOVEMENT TO CONSIDER THESE
THINGS MORE AS LIKE MEDICINES
AND THEREFORE SORTED OF
REQUIRING MORE RESEARCH TO FIND
OUT REALLY HOW, YOU KNOW, AGAIN,
IS THIS JUST THE HAWTHORNE
EFFECT THAT WE WERE LIKE BECAUSE
WE WERE WATCHING SO WE SAW AND
THEN WE CHANGED FOR A BIT, BUT
THEN OUR SORT OF WE GOT BURNED
OUT ON THAT STIM EXPLUS IT NO
LONGER WAS EFFECTIVE?
WE DOAN KNOW FOR A LOT OF
THIS -- ON THAT STIMULUS AND IT
NO LONGER WAS EFFECTIVE?
WE DON'T KNOW FOR A LOT OF THIS
STUFF.
>> THE IDEA OF REGULATING THESE
AS MEDICINES ALSO BRINGS UP YOUR
POINT ABOUT BOTH CAUTIONS TO THE
RESEARCHERS TO KNOW, LIKE, OH, I
COULD USE THIS FOR THAT, FOR
THEM TO UNDERSTAND THE DATA
THAT'S BEING USED TO SEE THAT
THAT STHING EFFECTIVE IN
MEASURING -- THAT THING IS
EFFECTIVE IN MEASURING THE THING
OF INTEREST, AND FOR US AS
POTENTIAL PARTICIPANTS OF MAYBE
ASKING THE INVESTIGATOR, YOU
KNOW, WHAT DO YOU KNOW ABOUT
THIS TECHNOLOGY?
WHY DID YOU DECIDE TO USE THIS
PARTICULAR TECHNOLOGY TO FOLLOW
THIS, OR JUST MY KNOW BEING
ENOUGH, BEING PRESENTED ENOUGH
INFORMATION IN THE INFORMED
CONSENT FORM TO APPRECIATE WHAT
THE LIMITATIONS OF THIS
TECHNOLOGY ARE.
>> YEAH, AND I THINK THE ABILITY
TO DO REALLY MEANINGFUL INFORMED
CONSENT, ESPECIALLY WHEN IT
MIGHT NOT BE REQUIRED IN THIS
CONTEXT, CONSIDERED MINIMAL
RISK, CONSIDERED THE KIND OF
TWHRING AT MOST YOU'RE CLICKING
A BOX, ACCEPTING THE COOKIES,
THE FRICTION TO ADOPTION
COMPARED TO LIKE AN IMPLANTED
DEVICE IS SO LOW, AND, IN FACT,
MANY OF THEM HAVE ALREADY BEEN
ADOPTED, IN FACT, THAT'S WHY WE
THINK THERE'S THEY'RE A GOOD
PLATFORM FOR OUR RESEARCH, IT
REALLY BEGS THE QUESTION OF WELL
WHAT ELSE NEEDS TO BE DONE IN
TERMS OF LIKE ACTUALLY SHARING
WHAT WE'RE FINDING, SHARING WHAT
WE'RE DOING WITH IT, SO THAT
PEOPLE CAN UNDERSTAND THE
CONTENT AND THE CONTEXT, RIGHT,
OF EVEN WHAT BHENT ON THAT FORM
IN THE FIRST PLACE.
>> L.
I WOULD LOVE TO, IF YOU HAVE ANY
QUESTIONS OR THOUGHT, I WOULD
LOVE TO HEAR, OR CHALLENGES, I
WELCOME VERY MUCH.
>> I HAVE ANOTHER QUESTION FROM
OUR VIRTUAL AUDIENCE.
IETA ASKS, IN WEARABLES, SUCH AS
SMARTWATCHES, IS THERE ANY
LEGISLATION FOR DATA PROTECTION
IN THE U.S. AS IN EUROPE THAT
LEGAL DATA PROTECTION COULD BE
RELATED TO RESEARCH ETHICS, FOR
EXAMPLE?
I DON'T KNOW HOW FLUENT YOU ARE
IN THE EU RULES ABOUT THIS.
>> YEAH, IT'S VERY INTERESTING,
RIGHT?
SO A LOT OF THE EU GOVERNANCE,
YOU KNOW, FROM LIKE A POLITICAL
SENSE OVER DATA IS FAR STRONGER
THAN WHAT WE HAVE IN THE UNITED
STATES.
AT THE SAME TIME, MOST OF THE
TECHNOLOGIES ARE COMING FROM
EITHER U.S. BASED COMPANIES OR,
YOU KNOW, ELSEWHERE OUTSIDE OF
EUROPE.
SO EUROPE KIND OF HAS THIS VERY
INTERESTING, VERY
PHILOSOPHICALLY INFORMED
POLITICAL PERSPECTIVE ON HOW
THESE DATA COULD BE USED BY THE
STATE.
THEY'RE ALSO A LITTLE BIT
SEPARATED FROM ALL OF THE
PROCESSES THAT ARE PRODUCING
THESE TECHNOLOGIES, AND I THINK,
YOU KNOW, THE BARN DOOR IS BEING
OPEN AND WHAT NOT BEING
SOMETHING THAT'S VERY HARD TO
WRAP BACK IN.
BUT, YOU KNOW, THEY ARE MAKING
STRIDES, AND I THINK THAT
THERE'S SOME DATA PROTECTIONS,
BUT AGAIN, NOT LIKE THERE ARE
OVER DATA THAT YOU MIGHT THINK
OF AS LIKE THE INLTD MA SI OF
THE DATA -- INTIMACY OF THE DATA
THAT'S COLLECTED FROM THESE
DEVICES GOES WAY BEYOND WHAT'S
IN YOUR ELECTRONIC MEDICAL
RECORD BECAUSE IT'S QUITE
LITERALLY SENSING WHAT'S IN YOUR
BODY, IT MIGHT NOT BE VALID BUT
PEOPLE MIGHT TREAT IT AS SUCH.
SO I THINK THERE'S A NEED FOR
CONSUMER DEMAND AND CONSUMER
AWARENESS AROUND THESE THING AS
WELL TO SORT OF DRIVE THOSE LIKE
VERY INCREMENTAL LEGISLATIVE
CHANGES THAT REALLY REQUIRE A
CULTURAL CHANGE MORE THAN -- AND
LIKE NEW EXPECTATIONS, AS
OPPOSED TO JUST LIKE NEW
REGULATIONS COMING OUT OF THIN
AIR.
YEAH, OR BOTH.
CAROLINE, YOU GET THE LAST WORD.
YEAH, THANK YOU FOR THIS
TALK.
IT WAS SUPER-INTERESTING.
WHAT IT'S BRINGING UP FOR ME I
THINK IS THIS IDEA OF LIKE
HYPER-INDIVIDUALIZATION OF
HEALTH DATA AND
COMMERCIALIZATION OF HELIDATA
AND KIND OF THE EMERGENCE OF,
YOU KNOW, ALL OF US PING ACCESS
TO VERY MINUTE DETAILS OF OUR
HEALTH DATA WHEN IT MIGHT NOT BE
HELPFUL ON AN INDIVIDUAL LEVEL
BUT INSTEAD ON A POPULATION
LEVEL, AND I'M WONDERING YOUR
THOUGHTS ON, YOU KNOW, HOW DO WE
ENSURE, LIKE OBVIOUSLY WE WANT A
BIG THING IS THAT WE WANT PEOPLE
TO HAVE ACCESS TO THEIR
INDIVIDUAL DATA WHEN IT'S
CONTRIBUTE TO GO A STUDY, BUT
ALSO HOW DO WE ENSURE THAT LIKE
IT'S FRAMED IN SUCH A WAY SO
THAT PEOPLE UNDERSTAND THAT --
OR LIKE THAT THE INDIVIDUAL DATA
ISN'T ACTUALLY HARMFUL TO THE
PERSON WHEN IT'S MAYBE NOT -- WE
DON'T HAVE THE INFORMATION ABOUT
WHETHER OR NOT THIS PARTICULAR
DATA POINT IS GOING TO BE USEFUL
ON LIKE AN INDIVIDUAL LEVEL, IF
THAT MAKES SENSE.
DOES THAT MAKE SENSE?
SORRY.
I WOULD KIND OF GO ALMOST IN
REVERSE ORDER.
SO ONE THING THAT THERE'S A LOT
OF PATERNALISM IN TERM OF HOW
THE RESEARCH COMMUNITY VIEWS THE
IDEA OF GIVING PEOPLE ACCESS TO
THE DATA THAT WE'VE COLLECTED
FROM THEM IN THE COURSE OF
RESEARCH STUDY.
LARGELY I THINK THAT'S ABOUT
POWER AND CONTROL OVER THE DATA
AND JUST SIMPLY NOT WANTING TO
SHARE IT, AND IS KIND OF ROOTED
IN TRADITIONAL SORT OFLIKE THE
SAME REASONS WHY DOCTORS DIDN'T
WANT PATIENTS TO BE ABLE TO READ
THEIR NOTES, LIKE OH, IT COULD
HURT THEM.
LIKE MM, BUT OKAY, PEOPLE HAVE A
NEW NORM NOW, RIGHT?
PEOPLE WANT TO KNOW THE LAB
RESULTS, THEY WANT TO KNOW THEIR
DATA, AND THAT HAS THE POTENTIAL
TO BE HARMFUL BUT SORT OF PEOPLE
GENERALLY KNOW THAT AND YOU CAN
SAY THIS ALSO MIGHT NOT BE
USEFUL, IT MIGHT STRESS YOU OUT
TO FIND THAT OUT, BUT I THINK
CONCERNS ABOUT THE POTENTIAL
HARM OF THAT INFORMATION IS
NEVER GOING TO BE REALLY A
LEGITIMATE REASON TO WITHHOLD
IT.
THAT'S ONE.
THEN THE SECOND POINT I THINK
WHAT'S CRITICAL IS THAT IF YOU
TRULY PROPERLY CONSIDER
INCLUDING PARTICIPANTS AS
MEMBERS OF THE RESEARCH TEAM AND
THAT IT'S NOT JUST ABOUT GIVING
THEM THEIR OWN DATA, BUT IT'S
ACTUALLY SAYING LIKE HERE IS THE
DATASET WE'VE COLLECTED, YOU'RE
LINE 18 AND, YOU KNOW, HERE IS
THE DRAFT OUR -- LIKE WE'RE
DOING RIGHT NOW FOR ONE OF OUR
PROJECTS, I'M SENDING TO LIKE
1,000 RESEARCH PARTICIPANTS THE
DRAFT THE MANUSCRIPT THAT I'M
WRITING ABOUT THE STUDY THAT
THEY PARTICIPATED IN, AND FOR
THEIR COMMENTS, FEEDBACK,
THOUGHTS, LIKE IT'S KIND OF
NERVE WRACKING, AND I'M SENDING
THEM THE DATASETS DEIDENTIFIED,
OF COURSE, WITH THE ABILITY TO
PERSONAL AM IDENTIFY THEMSELVES
WITHIN THE DATA THAT ACTUALLY
SAYS, WELL, TREAT THEM LIKE TRUE
COLLABORATORS, AND THEY CAN, YOU
KNOW, SOME OF THEM ARE VERY
SOPHISTICATED, SOME OF THEM HAVE
AI TOOLS THAT ARE VERY
SOPHISTICATED THIS THEY MIGHT
WANT TO LOOK AT THAT DATA
THEMSELVES OR AT LEAST HAVE THE
ABILITY TO OR THE ABILITY TO
OBTAIN ANOTHER OPINION.
I THINK IT'S PARTIALLY ABOUT
REALLY JUST BASIC INCLUSION, AND
AGAIN, THE STRUCTURES THAT MIGHT
PREVENT THAT FROM HAPPENING I
THINK HAVE A LOT MORE TO DO WITH
THE PROPRIETARY NATURE OF THAT
DATA AND NOT ABOUT LIKE WHAT WE
THINK IS ACTUALLY GOOD FOR
PEOPLE, WHAT WE THINK IS
ACTUALLY JUST.
>> YEAH, THANK YOU.
>> I THINK WE'RE GOING TO HAVE
TO CUT OFF.
>> WE CAN TALK MORE.
>> BUT THIS IS A GREAT DOFERTION
PICK UP WHEN WE ALL MEET THE
FELLOWS AND YOU.
KEEP ALL THAT IN MIND.
>> THANK YOU SO MUCH.
THANK YOU.
[APPLAUSE]
>> THANKS, EVERYBODY, IT'S
10:23.
WE ARE GOING TO COME BACK
TOGETHER AT 10:35 FOR OUR THIRD
LECTURE TODAY, WHICH IS BE ON
GENERATIVE ARTIFICIAL
INTELLIGENCE AND LARGE LANGUAGE
MODELS.
THANK YOU.
WELCOME BACK EVERYONE, THIS IS A
BITTERSWEET LAST LECTURE IN OUR
CLASS THIS YEAR.
IT'S MY PLEASURE TO INTRODUCE
VASILIKI RAHIMZADEH, WE GET TO
CALL HER VASO, SHE IS AN
ASSISTANT PROFESSOR AT THE
CENTER FOR MEDICAL ETHICS AND
HEALTH POLICY AT BAYLOR MEDICAL
COLLEGE, AND SHE INVESTIGATES
THE ETHICAL, LEGAL AND SOCIAL
ISSUES OF HEALTH DATA SHARING
ACROSS EMERGING COMPUTING
ENVIRONMENTS.
THE GOALS OF HER RESEARCH ARE TO
INFORM DATA GOVERNANCE POLICY
AND PRACTICE, WHICH MAXIMIZES
THE SCIENTIFIC VALUE OF HEALTH
DATA AND RESPECTS THE RIGHTS AND
INTERESTS OF INDIVIDUALS AND
COMMUNITIES.
AND QUICK SIDE NOTE, VASO IS THE
CO-CHAIR OR CHAIRS THE ASTRO
ETHICS AFFINITY GROUP, WHICH
WE'RE GOING TO HAVE HER COME
BACK AND TALK ABOUT ASTRO ETHIC
AT A LATER TIME.
SO WITH THAT, I'M GOING TO HAND
IT OVER TO VASO.
>> GOOD MORNING, EVERYONE.
YOU CAN HEAR ME OKAY?
THANKS SO MUCH FOR THAT
SUPER-KIND INTRODUCTION AND FOR
HAVING ME WITH YOU TODAY.
I WISH I COULD BE THERE IN
PERSON, YET COVID STRIKES AGAIN,
WE ARE CONTINUING TO LIVE WITH
IT.
BUT THANKS TO TECHNOLOGY, I'M
ABLE TO STILL BE ABLE TO SHARE
HAD SOME THOUGHTS AND SOME
DISCUSSIONS WITH YOU TODAY ABOUT
THE ETHICAL CONSIDERATIONS OF
USING GENERATIVE AI FOR RESEARCH
WITH HUMAN SUBJECTS.
SO, YOU KNOW, I'LL START OFF BY
SAYING WE'RE REALLY IN QUITE AN
UNPRECEDENTED ERA AS FAR AS
ADVANCEMENTS IN AI ARE
CONCERNED.
SO THE INTEGRATION OF GENERATIVE
AI IN SPECIFIC AND WE'LL TALK
ABOUT LLM'S OR LARGE LANGUAGE
MODELS IN PARTICULAR HAS THIS
REALLY UNIQUE ABILITY TO
TRANSFORM QUITE LITERALLY HOW WE
DO CLINICAL AND SOCIAL SCIENCE,
ENHANCING BOTH THE PRECISION AND
EFFICIENCY OF SOME OF THOSE
CLINICAL STUDIES, WHILE ALSO
POTENTIALLY ENABLING BROADER
REACH AND REPRESENTATION OF
PARTICIPANT POPULATIONS THAT WE
KNOW HAVE BEEN UNDERREPRESENTED
IN RESEARCH TO DATE.
BUT AS WITH ANY TECHNOLOGICAL
ADVANCES, GENERATIVE AI IN
SPECIFIC HAS RAISED SOME
ADDITIONAL RESEARCH ETHICS,
TENSIONS, ALBEIT MANIFESTING IN
NOVEL WAYS AND HAVE ALSO RAISED
ENTIRELY NEW ETHICAL ISSUES
WHERE OUR EXISTING FRAMEWORKS
MAY BE INSUFFICIENT TO REALLY
HELP US FIND ALL THE ANSWERS.
SO I HOPE TO EXPLORE AND DISSECT
SOME OF THOSE ISSUES WITH YOU
TODAY IN PRAGMATIC WAYS THAT
REALLY TAKE INTO ACCOUNT SOME OF
THOSE REALISTIC AREAS THAT AI
CAN HELP IN MAKING HUMAN
SUBJECTS RESEARCH MORE RIGOROUS
AND TRUSTWORTHY BUT ALSO
ACKNOWLEDGING THEIR VERY REAL
LIMITATION.
SO I AM GOING TO ARGUE TODAY
REALLY AT THE VERY CORE OF THE
INTERSECTION OF MACHINE AND
INTELLIGENCE AND HUMAN HEALTH
RAISES QUESTIONS ABOUT CONSENT
AND TRANSPARENCY AND PRIVACY AND
EQUITY, AS WELL AS THE OVERALL
INTEGRITY OF THE SCIENTIFIC
ENDEAVOR.
AND I'M GOING TO START OFF WITH
A VERY SIMPLE TEMPERATURE CHECK
OF YOU ALL IN THE ROOM AND
ONLINE, AND I'M GOING TO SWITCH
SCREENS FOR THIS.
I'M GOING TO ASK YOU VERY
SIMPLY, YOU KNOW, WHAT WORDS
COME TO MIND WHEN YOU THINK OF
ARTIFICIAL INTELLIGENCE?
THEY CAN BE IN THE HEALTH SPACE,
THEY CAN BE IN THE RESEARCH
SPACE, AND THE WAY THAT YOU
ANSWER THIS POLL IS BY GOING ON
YOUR SMART DEVICE OR ON YOUR
LAPTOP TO
POLLEV.COM/NIHBIOETHICS, YOU CAN
SUBMIT YOUR ANSWERS VIA E IT OR
YOU CAN SIMPLY SCAN THE QR CODE.
I'LL GIVE PEOPLE A FEW MINIMUM
TTS TO DO THAT, OR 30 SECONDS,
WE'LL SAY -- A FEW MINUTES TO DO
THAT OR 30 SECONDS, WE'LL SAY,
TO DO THAT.
[PAUSE]
ALL RIGHT.
WE'LL SEE HOW WE'RE GOING.
NICE.
SO CHATGPT REALLY REIGNING
SUPREME HERE.
ROBOTS, WE'VE GOT REPLACEMENT, I
THINK THAT'S REALLY INTERESTING.
COMPUTERIZED, WE'LL KEEP GOING.
I LOVE IT.
FIVE MORE SECONDS.
OKAY.
SUPER.
ROBOTS, CHATGPT, MACHINES REALLY
KIND OF COMING TO THE FORE HERE
WITH SOME GREAT ONES I HAVEN'T
HEARD WHEN I HAVE DONE THIS
ACTIVITY BEFORE, SO THINGS LIKE
I THINK I SEE CYBORGS AND
INVASIVENESS, REALLY
INTERESTING, UNPREDICTABLE,
UNBELIEVABLE, I SEE
DISCRIMINATORY, ALEXA KIND OF
PEEPING IN THERE, THAT'S REALLY
AWESOME.
SO YEAH, YOU KNOW, I THINK IT'S
REALLY INTERESTING TO HIGHLIGHT,
YOU KNOW, HOW MANY ASSOCIATIONS
ARTIFICIAL INTELLIGENCE HAS IN
THE PUBLIC CONSCIOUSNESS TO
DATE, YOU KNOW, THE WAY WE'RE
EXPOSED TO THESE TECHNOLOGIES
ARE REALLY A FEATURE OF THE
MEDIA WE CONSUME, THE
TECHNOLOGIES AND THE AREAS OF
RESEARCH WE HAVE MOST PROXIMITY
TO, AND I THINK THIS WORD CLOUD
EXERCISE REALLY HELPS KIND OF
UNVEIL SOME OF THOSE EXPOSURES
WITHIN THE BROADER PUBLIC.
SO THANKS FOR THAT.
WE'RE GOING TO DO ONE MORE, AND
THIS NEXT QUESTION I HAVEN'T
POSED BEFORE, BUT I THINK IS
REALLY ONE THAT'S TOP OF MIND
FOR US AS EARLY CAREER
RESEARCHERS AND THOSE WHO WILL
REALLY ENTER INTO THE RESEARCH
ENDEAVOR WITH SOME OF THESE
TECHNOLOGIES BEING VERY
INTEGRATED, AND THAT'S, WOULD
YOU EVER CONSIDER USING CHATGPT
TO DRAFT A SPECIFIC AIMS PAGE
FOR AN NIH GRANT YOU MIGHT BE
SUBMITTING?
AND THIS IS COMPLETELY
ANONYMOUS, SO NOBODY, NONE OF
THE PROGRAM OFFICERS ACROSS THE
WAY ON CAMPUS WILL KNOW WHAT YOU
WROTE HERE, BUT I AM
SUPER-CURIOUS TO HEAR WHETHER
YOU WOULD CONSIDER DOING THIS.
[PAUSE] HAD WE'LL GIVE.
WE'LL GIVE IT JUST A FEW MORE
SECONDS.
ALL RIGHT.
REALLY INTERESTING.
ALL RIGHT.
SO WE'VE GOT 71% WOULD CONSIDER
USING IT, AND AROUND 20%, ABOUT
20% SAYING NO, AND THAT A
HEALTHY 10% I'M NOT SURE.
SO THANKS ARE FOR ENGAGING IN
THAT EXERCISING I THINK WE'LL
TALK A LITTLE BIT ABOUT WHAT
MIGHT BE SOME OF THE ETHICAL
RATIONALES FOR WHY IT MIGHT BE
APPROPRIATE OR ACCEPTABLE TO USE
CHATGPT IN WRITING GRANT
PROPOSALS OR IN THE GRANT
WRITING PROCESS AND WHAT
CHALLENGES THAT MIGHT POSE.
SO THANKS FOR THAT.
I'M GOING TO GO BACK TO MY
PRESENTATION.
ALL RIGHT.
SO, YOU KNOW, TODAY I'M REALLY
GOING TO START BY RIGHT OUT THE
GIT-GO SHARING TWO UNDERLYING
POSITIONS I HOLD WITH RESPECT TO
GENERATIVE AI AND ENABLING
RESPONSIBLE CONDUCT OF RESEARCH.
THE FIRST IS THAT GENERATIVE AI
CAN ADVANCE ETHICAL HUMAN
SUBJECTS RESEARCH WHEN APPLIED
IN WAYS THAT COMPLEMENT HUMAN EN
DEFERS TO ENSURE -- ENDEAVORS TO
ENSURE RIGOR AND TRUSTWORTHINESS
WITHIN THE RESEARCH ECOSYSTEM
AND ACROSS RESEARCH PROCESSES,
AND I REALLY BELIEVE IT'S OUR
JOB AS BIOETHICIST, AS PEOPLE,
AS RESEARCHERS WHO INVOLVE
HUMANS IN THE RESEARCH WE DO TO
IDENTIFY, YOU KNOW, REALLY WHEN
AND WHERE RIGOR AND
TRUSTWORTHINESS ARE MOST
THREATENED BY GENERATIVE AI AND
LLM'S IN PARTICULAR, AND HOW TO
MITIGATE THOSE THREATS.
AND THE SECOND IS THAT, YOU
KNOW, REGARDLESS ABOUT OUR OWN
BELIEFS OF THE TECHNOLOGY, WE DO
HAVE THIS RESPONSIBILITY TO
UNDERSTAND ITS IMPACT ON
RESEARCH.
SO MY SECOND POSITION, MY SECOND
POINT IS THAT THE RESEARCH
ETHICS COMMUNITY HAS AN
ESPECIALLY IMPORTANT ROLE TO
PLAY IN HOW GENERATIVE AI IS NOT
ONLY DEVELOPED AND INNOVATED BUT
ALSO THAT WE NEED ETHICISTS TO
BE PRESENT ON THE GROUND FLOOR
OF THIS DEVELOPMENT TO ALSO
RESPONSIBLY SHAPE ITS
IMPLEMENTATION.
SO IN THE COURSE OF THE NECK --
IN THE COURSE OF NEXT 30 MINIMUM
TTS OR 60 MINUTES WE HAVE
TOGETHER, I HOPE WHAT WE DISCUSS
WILL INSPIRE SOME PERSONAL
REFLECTION ON SEVERAL KEY
QUESTIONS THAT I'VE BEEN ASKING
MYSELF, WHICH PRIMARILY IS, YOU
KNOW, IS IT EVER ETHICAL TO USE
GENERATIVE AI IN LLM'S IN
PARTICULAR TO DESIGN AND/OR
CONDUCT AND/OR DISSEMINATE OR
PEER REVIEW RESEARCH?
AND IF SO, WHEN AND HOW?
SO I HOPE TO BE ABLE TO
DEMONSTRATE THAT IT CAN BE, WHEN
IT DOESN'T VIOLATE REALLY
CROSS-CUTTING ETHICAL PRINCIPLES
AND PRIORITIES THAT UNDERGIRD
RESEARCH RIGOR AND SOCIALLY JUST
SCIENCE.
I'VE MOSTLY BEEN THINKING ABOUT
LLM'S IN THE CONTEXT OF
BIOETHICS AND LEARNING, I
RECENTLY PUBLISHED A PAPER WITH
COLLEAGUES ON THE CENTER FOR
MEDICAL ETHICS AND HEALTH POLICY
AT BAYLOR THINKING ABOUT WHAT
SOME APPLICABLE USES OF CHATGPT
TO BIOETHICS TEACHING AND
LEARNING MIGHT BE, BUT PREPARING
FOR THIS TALK REALLY RAISED
ACTUALLY SOME NEW QUESTIONS
ABOUT HOW WE AS THE RESEARCH
COMMUNITY CONCEPTUALIZE THINGS
LIKE NOVELTY AND ATTRIBUTION IN
RESEARCH AND HOW THAT'S POSING
NEW CHALLENGES AND ISSUES WHEN
USING THINGS LIKE DHAT GPT TO --
CHATGPT TO HELP US POSE NEW
RESEARCH QUESTIONS, MAYBE
EXPRESS IDEAS THROUGH RESEARCH
ARTICLES AND OTHER TEXTS AND HOW
IT HELPS SUPPORT US DOING THAT
AND WHETHER THIS QUESTION ABOUT
WHETHER HUMANS ARE REALLY THE
ONLY ONES THAT ARE CAPABLE OF
THIS NOVELTY.
I'VE ORK NILESED MY REFLECTIONS
ON LLM'S ON FOUR LIFETIMES,
STARTING WITH RESEARCH DESIGN
THROUGH TO A SCIENTIFIC AND
ETHICS PEER REVIEW AND ONTO THE
ACTUAL CONDUCT OF RESEARCH AND
FINALLY DISSEMINATION OF
RESEARCH PRODUCTS.
SO FOLLOWING EACH SECTION, I'LL
PROVIDE WHAT I'M CALLING AN
EMERGENT APPLICATION OR AN
EVOLVING USE CASE OF AN LLM THAT
REALLY PUTS SOME OF THOSE ISSUES
WE DISCUSS INTO RELIEF.
I PROPOSE AT LEAST WE SHOULD
CONSIDER FIVE ETHICAL PRIORITIES
THAT CAN HELP US GUIDE WHETHER,
HOW AND WHY WE USE LLM'S FOR
RESEARCH AT ANY STAGE IN THE
RESEARCH PROCESS.
SO I'VE ORGANIZED THEM IN TERMS
OF RIGOR AND CREDIBILITY, DATA
FELT, WHICH IS A COMBINATION OF
BOTH THE QUALITY AND THE
SUFFICIENCY OF THAT DATA TO
ANSWER SCIENTIFIC QUESTIONS,
NATURALLY QUESTIONS ABOUT
PRIVACY AND CONFIDENTIALITY COME
UP, AS WELL AS THINGS LIKE
JUSTICE AND TRANSPARENCY.
SO AS WE ADVANCE IN OUR
DISCUSSIONS, MY OVERALL GOALS
FOR TODAY REALLY ARE TO HELP YOU
GAIN PERHAPS A BETTER CONCEPTUAL
UNDERSTANDING OF THE TECHNICAL
CAPABILITIES AS WELL AS
LIMITATIONS OF LARGE LANGUAGE
MODELS AND HOW THEY'RE
DISTINGUISHED FROM OTHER
ARTIFICIAL INTELLIGENCE
TECHNOLOGIES, AND SECOND TO
REALLY CONSIDER AND WORK THROUGH
SOME OF THOSE ETHICAL, LEGAL AND
SOCIAL IMPLICATIONS OF LLM'S AT
EACH THOSE PHASES IN THE
RESEARCH PROCESS.
SO FOR SOME OF YOU THIS MAY BE
THE FIRST EXPOSURE TO THE
TECHNICAL SIDE OF AI, SO THE
NEXT FEW SLIDES ARE REALLY MEANT
TO COMPLEMENT SOME OF THE
SUGGESTED READINGS I HAD FOR
TODAY AND PROVIDE A BRIEF PRIMER
AND EXPAND YOUR AI VOCABULARY A
BIT.
SO AI DESCRIBES A TECHNIQUE
WHERE COMPUTERS ARE QUITE SIMPLY
PROGRAMMED TO MIMIC HUMAN
INTELLIGENCE AND ANALYTIC
BEHAVIORS.
AND ONE METHOD BY WHICH
COMPUTERS ARE ABLE TO ENABLE AI
IS THROUGH MACHINE LEARNING.
SO MACHINE LEARNING USES THESE
LARGE DATASETS THAT HUMANS
ESSENTIAL GIVE IT TO IDENTIFY
PATTERNS IN DATA THAT CAN BE
USEFUL FOR THINGS LIKE
PREDICTION, CALCULATING RELATIVE
RISK AND ISOLATING CAUSAL
INFERENCE.
AND THESE PATTERNS CAN BE USED
TO CREATE MODELS THAT THE
MACHINE EVOLVES OVER TIME IN
RESPONSE TO NEW DATA IT'S FED
AND NEW INPUTS THAT IT'S
PROVIDED.
AND THIS IS THE LEARNING PART OF
MACHINE LEARNING, WHICH CAN
OCCUR IN A SUPERVISED, THAT IS
WITH HUMAN INTERVENTION OR
WITHOUT IN AN UNSUPERVISED
FASHION.
SO UNDER THE UMBRELLA OF MACHINE
LEARNING ARE SYSTEMS CAPABLE OF
DIFFERENT TYPES OF ANALYTICS.
SO THERE'S THIS SUBSET OF AI
CALLED DEEP LEARNING WHICH
TEACHES COMPUTERS TO PROCESS
DATA IN A WAY THAT IS ACTUALLY
INSPIRED BY WHAT WE KNOW OF THE
HUMAN BRAIN ITSELF.
SO IN THIS SPACE BETWEEN DEEP
LEARNING AND MACHINE LEARNING,
WE HAVE GENERATIVE AI.
HAD GENERATIVE AI IS THIS
SUBCLASS OF DEEP LEARNING MODELS
THAT TAKE SOME RAW DATA, SAY
IT'S ALL OF THE DATA FROM NIH
REPORTER OR EVERY ARTICLE
WRITTEN IN THE WASHINGTON POST
AND LEARNS TO PREDICT THE MOST
STATISTICALLY PROBABLE NEXT
STRING OF TEXT IN RESPONSE TO A
USER'S PROMPT.
AND IT CAN BE TEXT, IT CAN BE 3D
IMAGES, IT CAN BE OTHER CONTENT
THAT'S BASED ON THIS RAW DATA
THAT MODELS ARE TRAINED ON.
SO COMMON TYPES OF DATA INCLUDE
CODE, THEY CAN INCLUDE TEXT,
WHICH IS WHAT I THINK PEOPLE ARE
FAMILIAR WITH WITH CHATGPT,
EMERGING TECHNOLOGIES LIKE AM
DOLL-E RESPONDS IT TEXT
RESPONSES IT GENERATES IMAGES
THAT ARE ASSOCIATED OR ARE
PREDICTED TO BE SOASHED WITH
THOSE -- ASSOCIATED WITH THOSE
TEXT INPUTS.
SO IN ESSENCE, THE RESPONSE YOU
GET FROM AN LLM AND BY PROMPTING
GENERATIVE AI STOOLS A SUMMARY
OF ALL THAT DATA IT'S TRAINED
ON, AND IT'S BEEN SYNTHESIZED
AND CREATED BY THE TOOL.
SO THAT SUMMARY IS SIMILAR TO
BUT NOT ESSENTIALLY IDENTICAL TO
THE RAW DATA THAT IT'S TRIEND,
AND THIS IS PROBABLY THE --
TRAINED ON, AND THIS IS PROBABLY
THE MOST IMPORTANT FEATURE OF
GENERATIVE AI BECAUSE IT DOES
RAISE QUESTIONS ABOUT THE LIMITS
OF INTELLECTUAL PROPERTY,
PLAGIARISM, WHICH ACTUALLY WE
SAW AS PART OF THE WORD CLOUD,
AND AGAIN THE NOVELTY OF
RESEARCH IDEAS.
SO LLM'S ARE INTERNAL VERY GOOD
AT SUMMATION, VERY GOOD AT
CLASSIFICATION AND PREDICTION OF
VARIOUS TYPES OF INPUTS AND
RESEARCH CAN REALLY --
RESEARCHERS CAN REALLY LEVERAGE
THOSE STRENGTHS AND PUT THEM TO
EFFECTIVE USE IN THEIR RESEARCH.
SO LLM'S HAVE RISEN IN
POPULARITY LARGELY THANKS ON
OPEN AI'S CHATGPT BUT THE LLM
MARKET ITSELF IS ACTUALLY
SATURATED AND EXPANDING QUITE
RAPIDLY.
SO WE ALSO HAVELY POM2, THIS IS
GOOLGS COMPETITIVE LLM TO
CHATGPT, NOT TO BE OUTDONE BY
CLOD HE A NEW PRODUCT RELEASED
BY A COMPANY CALLED ANTHROPIC.
I SHARE THESE JUST TO GIVE A
SENSE OF HOW MANY DIFFERENT
PRODUCTS ARE BEING RELEASED ON
THE MARKET BECAUSE THERE'S AN
EVOLVING DEMAND FOR THEM ACROSS
VARIOUS SECTORS.
SO GIVEN ITS UNIQUE STRENGTH AND
IS CAPABILITIES IT'S IMPORTANT
TO DISTINGUISH WHAT AN LLM IS
NOT.
GENERATIVE AI CAN COMMONLY BE
MISTAKEN AS AN INFORMATION
REPORTING TOOL OR A SEARCH
ENGINE, WHEN IN FACT IT'S
NOTHING MORE THAN AN INFORMATION
PARROT OR A SYNTHESIZING TOOL.
SO AS IN THE CASE OF CHATGPT,
IT'S ALSO PERPETUALLY STUCK IN
THE YEAR 2021, SO IT WOULDN'T BE
ABLE TO PROVIDE ANY TIMELY
UPDATES ON, FOR EXAMPLE,
RECENTLY PASSED LAWS, ANY
CURRENT EVENTS OR SOCIAL CHANGES
THAT ARE HAPPENING IN REALTIME
BUT WOULD INEVITABLY AFFECT THE
RESPONSES YOU GET.
ANOTHER THING LLM'S ARE NOT ARE
STORAGE CENTERS OR REPOSITORIES,
SO DHOANLT STORE DATA IN THE
SAME WAY -- THEY DON'T STAR DATA
IN THE SAME WAY THAT A DATABASE
OR A LITERATURE SEARCH ENGINE
MIGHT DO AND IMPORTANTLY THEY'RE
AT ANY TIME A VERIFIABLE SOURCE,
SO LLM'S CAN'T TESTIFY TO THE
TRUTHFULNESS OR INTEGRITY OR
VERACITY OF THE DATA THAT IT'S
GENERATING AND SPITTING BACK TO
YOU, AND THIS IS REALLY
CONSEQUENTIAL FOR RESEARCH RIGOR
AND DATA INTEGRITY.
SO DETION SPITE THE REALLY
EXPLOSIVE POPULARITY RECENTLY
AND PUBLIC INTEREST ACROSS MEDIA
COVERAGE IN THE LAST YEAR,
GENERATIVE AI ITSELF IS NOT ONLY
LIMITED TO LLM'S LIKE CHATGPT
BUT IT'S ALSO NOT NEW.
SO GENERATIVE AI HAS THIS REALLY
RICH THEORETICAL AND APPLIED
MATHEMATICAL HISTORY THAT DATES
BACK AT LEAST TO THE 1930S, AND
HAS BEEN HEAVILY INFLUENCED IN
THE EARLY YEARS BY WORK FROM
LINGUIST CHOMSKY AND FIRST CHAT
BOT CALLED WHY ELIZA IN THE LATE
19LY 0S.
IN DECADES THAT FOLLOWED WE SEE
REFINE REFINEMENT OF GENERATIVE
AI TECHNOLOGIES THAT CONVERGE
WITH THE BOOM OF COMPUTERRING
POWER AND BIG DATA ANALYTICS, IN
THE EARLY 2000S THE ERCHTS IS
INNOVATION FOR -- THE CENTERS
FOR INNOVATION FOR ARTIFICIAL
INTELLIGENCE SLOWLY MOVED OUT OF
ACADEMIA AND DEFENSE LABS TO
LARGE TECH COMPANIES LIKE GOOGLE
AND MICROSOFT JUST REALLY
DOMINATE THAT INNOVATION SPACE
AT PRESENT.
SO, YOU KNOW, EQUIPPED WITH KIND
OF THIS BASIC ALBEIT
FOUNDATIONAL UNDERSTANDING OF
WHAT LLM'S DO AND GENERATIVE AI
GENERALLY, WE'LL START TO EMBARK
ON THIS TOUR OF HOW LLM'S ARE
TRANSFORMING THE RESEARCH
ECOSYSTEM AND THE ETHICAL ISSUES
THAT REQUIRE CONSIDERATION ALONG
THE WAY.
AND WE'LL START WITH RESEARCH
DESIGN AND CONDUCT.
SO ONE OF THE MAIN MOTIVATIONS
FOR ADOPTING LLM'S IS THAT THEY
CAN HELP RESEARCHERS ACCELERATE
SPEED, EFFICIENCY OF DESIGNING
STUDIES, REALLY TRYING TO HELP
SPARK CREATIVE THINKING AND
IDEATION AND OVERCOME SOME
RATE-LIMITING STEPS IN THE
DESIGN PROCESS.
SO AT THE DESIGN STAGE, LLM'S
CAN REALLY CONFER SEVERAL
ADVANTAGES HAD.
BECAUSE THEY'RE TRAINED ON
ESSENTIALLY ALL THE INFORMATION
PUSHILY AVAILABLE ON THE
INTERNLTD, THEY CAN -- INTERNET
THEY CAN BE REALLY EFFECTIVE AT
ANALYZING KEY CONCEPTS AND
ENTIRE FIELDS OF LITERATURE,
HELPING RESEARCHERS ARRIVE AT
UNANSWERED QUESTIONS SOONER OR
HELPING TO EXPOSE KNOWLEDGE GAPS
THAT MIGHT REQUIRE YEARS --
MONTHS IF NOT YEARS TO DO
COMPREHENSIVE LITERATURE
SEARCHES, AS MANY OF YOU MIGHT
BE FAMILIAR WITH DOING.
LLM'S CAN ALSO BE HELPFUL IN HIM
INNING REAL PATTERNS IN HUMAN
LANGUAGE, SO CREATING
OPPORTUNITIES TO STUDY HUMAN
BEHAVIORS AND INTERACTIONS THAT
ARE EITHER INCREDIBLY DIFFICULT
OR PERHAPS DANGEROUS TO CAPTURE
IN THE NATURAL WORLD, SO IT
REALLY SUPPORTS DATA COLLECTION
AND ANALYSIS, AND IN THIS WAY,
LLM'S CAN ACTUALLY HELP CORRECT
PERHAPS ISSUES OF
UNDERREPRESENTATION AMONG
PARTICIPANT GROUPS AND ENABLE
STUDIES THAT MIGHT OTHERWISE BE
INFEASIBLE OR IMPRACTICABLE TO
CARRY OUT, AND WE'LL TALK A
LITTLE BIT MORE ABOUT HOW THEY
DO THIS LATER ON.
LLM'S CAN ALSO SUPPORT MAKING
KEY DECISIONS ABOUT DESIGN BY
PROPOSING VARIABLES TO STUDY, TO
HELP DEVISE CONTROL GROUPS FOR
TRIALS OR TO ASSIST IN
RANDOMIZING CONTROL GROUPS
WITHIN STUDIES.
AND THERE'S BEEN CONSIDERABLE
DEBATES OF LATE REGARDING THE
USE OF LLM'S TO SUPPORT GRANT
WRITING AND AS IT WAS I THINK
DEMONSTRATED IN THE SURVEY THAT
WE TOOK, YOU KNOW, THERE'S LOTS
TO TALK ABOUT, WHETHER CHATGPT
CAN ACTUALLY HELP IMPROVE GRANT
OUTCOMES BY MODELING SUCCESSFUL
GRANTEE WRITING STYLES AND
STRUCTURES.
SO ANYONE WHO HAS TAKEN, YOU
KNOW, AN NIH WRITING CLASS KNOWS
THAT NIH REALLY LIKES TO, YOU
KNOW, STANDARDIZE THE WAY THAT
GRANT APPLICATIONS ARE
FORMATTED, AND THIS KIND OF
TRANSLATES TO SPECIFIC TYPES OF
LANGUAGE. SO CHATGPT YOU CAN
ENVISION CAN HELP PAVE THE WAY
FOR MAYBE IMPROVED EQUITY GAINS
IN THE GRANT SUBMISSION PROCESS
FOR PEOPLE LIKE FIRST-TIME
APPLICANTS WHO HAVE NEVER
SUBMITTED A GRANT BEFORE, OR
PRIMARILY FOR PEOPLE FOR WHOM
ENGLISH MAY NOT BE THEIR FIRST
LANGUAGE.
SO THESE BENEFITS SHOULD NOT
THEMSELVES DRIVE LLM USE.
RATHER, YOU KNOW, REFLECTIONS
ABOUT WHETHER LLM'S ARE INDEED
CONDUCIVE TO THE SPECIFIC
RESEARCH TASK OR QUESTION OF
INTEREST SHOULD REALLY DRIVE
THOSE DECISIONS.
SO NOT ALL RESEARCH TASKS ARE
DESIGNED ALIKE, SO THERE SHOULD
BE THIS CONSIDERATION ABOUT
WHETHER LLM'S ARE APPROPRIATE TO
THE RESEARCH TASK OR QUESTION OF
INTEREST.
THERE'S ALSO A QUESTION ABOUT
WHETHER IT'S THE MOST RIGOROUS
WAY TO ACHIEVE THAT TASK, AND
RELATELY WHETHER IT'S THE MOST
FEASIBLE WAY TO DO THAT AS WELL.
AND I REALLY APPRECIATE HOW ALEX
LONDON ACTUALLY HELPS US THINK
THROUGH THE STRUCTURAL TYPES OF
PROBLEMS THAT AI HELPS US
OVERCOME IN THE RESEARCH
PROCESS, SO HE HAS THIS REALLY
HELPFUL DIAGRAM ABOUT, YOU KNOW,
HOW AI IN GENERAL IS, CAN BE
INTEGRATED WITHIN HEALTHCARE
SYSTEMS AND TO SUPPORT PATIENT
CARE, BUT I THINK MANY OF HIS
OBSERVATIONS LIKEWISE ARE REALLY
APPLICABLE TO RESEARCH, HE IS
SPESHLY REGARDING THE IMPACTS
THAT DATA FROM WHICH AI MODELS
ARE BUILT WILL HAVE ON THE
RESEARCH ENVIRONMENTS THAT AI
SYSTEMS ARE EVENTUALLY
IMPLEMENTED IN.
SO I HIGHLY RECOMMEND THIS PAPER
THAT CAME OUT IN CELL REPORTS, I
BELIEVE, IN 2022-H AND I THINK
WITH SO MUCH TALK OF MEDICAL AI,
THERE'S ALSO THIS TENDENCY TO
THINK LLM'S MAY JUST BE RELEVANT
FOR CLINICAL OR BIOMEDICAL
RESEARCH, BUT THERE'S THIS
GROWING ENTHUSIASM FOR
APPLICATIONS OF LLM'S TO SOCIAL
SCIENCE RESEARCH AS WELL.
SO HERE I'M EXCERPTING A PAPER
FROM GROSSMAN AND COLLEAGUES
THAT WROTE IN A RECENT PIECE,
EXCELLENT PIECE IN SCIENCE THAT
REALLY THESE ADVANCES IN LLM'S
ARE OFFERING OPPORTUNITIES TO
TEST THEORIES AND HYPOTHESES
ABOUT HUMAN BEHAVIOR AT GREAT
SCALE AND SPEED, THEY WRITE,
BECAUSE, QUOTE, THEY CAN
REPRESENT MYRIAD HUMAN
EXPERIENCES AND PERSPECTIVES,
POSSIBLY GIVING THEM A HIGHER
DEGREE OF FREEDOM TO GENERATE
DIVERSE RESPONSES AND WITH
HIGHER FIDELITY THAN HAS BEEN
PREVIOUSLY POSSIBLE WITH
CONVENTIONAL HUMAN PARTICIPANT
MODELS.
SO WITH THAT WE'VE COME TO OUR
FIRST EMERGENT APPLICATION AND
YOU'LL KNOW IT'S AN EMERGENT
APPLICATION WITH THAT LITTLE
SUNRISE ICON IN THE UPPER
LEFT-HAND CORNER AND THIS IS
LLM'S GENERATION OF SYNTHETIC
DATA.
SYNTHETIC DATA ARE ARTIFICIAL
DATA THAT'S CREATED BY
ALGORITHMS BUT CAN BE USED TO
TRAIN LLM'S, AND THEY CAN BE
USED, SYNTHETIC DATA CAN BE USED
TO SUPPLEMENT REAL WORLD DATA,
CAN BE INSPIRED BY REAL WORLD
DATA OR TO CREATE NEW DATA SETS
ALTOGETHER USING REAL WORLD DATA
AS A BASIS.
BUT SYNTHETIC DATA IS
ADVANTAGEOUS BECAUSE THEY ARE
GENERALLY NOT PERSONALLY
IDENTIFIABLE.
SO STUDIES WHICH USE OR
GENERATE, YOU KNOW, SYNTHETIC
DATA ARE THEREFORE NOT
CONSIDERED HUMAN SUBJECTS
RESEARCH AND WOULD LIKELY NOT
FALL UNDER THE AMBIT OF THE
COMMON RULE OR UNDER IRB REVIEW.
SO THE ADVANTAGE OF USING
SYNTHETIC DATASETS FOR RESEARCH
MIGHT THEREFORE BE TWOFOLD.
THEY COULD BETTER PROTECT
PARTICIPANT PRIVACY BECAUSE THEY
DON'T CONTAIN THIS PERSONALLY
IDENTIFIABLE INFORMATION, AND
THAT'S DIFFERENT THAN
DEIDENTIFIED INFORMATION WHICH,
YOU KNOW, CAME FROM SOMETHING
THAT'S PERSONALLY IDENTIFIABLE
AND THEN HAD SEVERAL IDENTIFIERS
REMOVED IN ORDER TO MAKE IT
DEIDENTIFIED.
SO SYNTHETIC DATA AT THE GIT-GO
DOESN'T CONTAIN ANY OF THOSE
IDENTIFIERS NOR HAD IT REMOVED
AT ANY POINT.
AND IT CAN BE USED, IT CAN BE
CREATED TO CONTROL FOR BIASES AS
WELL.
SO SYNTHETIC DATA CAN HELP
RESEARCHERS FILL IN GAPS WHERE
MAYBE THERE'S MISSING DATA, AND
THIS MISSING DATA LIMITS
POTENTIALLY THE INTERNAL OR
EXTERNAL VALIDITY OF FINDINGS,
AND IN THE PROCESS OF THAT
REALLY REDUCE THE RESOURCES
NEEDED TO COLLECT ADDITIONAL
DATA TO TRAIN THEIR ALGORITHMS.
AND THERE'S THIS REALLY
EXCELLENT REPORT FROM THE ROYAL
SOCIETY ON KIND OF THE WHO,
WHAT, WHEN, WHERE AND WHY OF
SYNTHETIC DATA ASK AND SOME NEW
SCHOLARSHIP COMING OUT ABOUT HOW
WE SHOULD TREAT SYNTHETIC DATA
IN COMPARISON TO DEIDENTIFIED OR
PROTECTED HEALTH INFORMATION.
SO ALL THESE BENEFITS ARE
POSSIBLE IF WE ASSUME SOME
PRETTY FOUNDATIONAL REALITIES
ABOUT THE ACTUAL DATA UPON WHICH
LLM'S ARE TRAINED ON, THAT CAN
BE SYNTHETIC OR REAL WORLD DATA,
AND I REALLY THINK ABOUT THEM IN
TERMS OF THREE PRIMARY SOURCES
OF BIAS OF THAT DATA.
SO THEY REALLY STEM FROM THE
QUALITY AND REPRESENTATIVENESS
OF THE TRAINING DATA AND THEY
ALSO CAN EMBED IN THE METHODS
AND CHOICES AROUND VALIDATION
AND FINALLY IN REAL WORLD
IMPLEMENTATION.
SO I THINK IT COMES AS NO
SURPRISE THAT, YOU KNOW,
LEARNERS IN THE ROOM THAT IF
DATA IS UNREMITTIVE --
UNREPRESENTATIVE OR QUALITY OF A
PHENOMENON OF INTEREST, MAYBE
THE MODEL WILL NOT LEARN THE
RELEVANT INFORMATION AS
EFFECTIVELY, AND AS A RESULT,
THIS HAS MAJOR SIGNIFICANCE ON
AN AI MODEL'S PERFORMANCE, IT'S
LIKELY TO SUFFER WITHOUT
APPROPRIATE REPRESENTATION FROM
POPULATIONS OF INTEREST, LEADING
TO THINGS LIKE INACCURATE
PREDICTIONS OR IN THE CASE OF
HEALTH RESEARCH, PERHAPS REDUCED
DIAGNOSTIC YIELD OR CAPABILITY.
WE REALLY WORRY ABOUT THINGS
LIKE GENERALIZEABILITY, SO IF WE
DON'T PUT IN QUALITY DATA, WE
WON'T BE ABLE TO ACTUALLY
GENERALIZE THOSE PATTERNS AND
FINDINGS ACROSS BROADER
PARTICIPANT POPULATIONS.
AND THAT MAY GUIDE SCIENTIFIC --
MAY MISGUIDE SCIENTIFIC
PRIORITIES AND ULTIMATELY LEAD
TO ASYMMETRICAL BENEFIT SHARING
AND BURDEN AND DISCRIMINATION,
AS AGAIN WE SAW IN THE WORD
CLOUD.
SO THE KEY TAKE AWAYS IS THAT
LLM'S, ESPECIALLY COMMERCIAL
LLM'S, ARE NOT REALLY DESIGNED
WITH RESEARCH OR CLINICAL DATA
PRIVACY COMPLIANCE IN MIND.
SO INPUT DATA THAT'S NEEDED TO
TRAIN, OPERATE OR REFINE LLM'S
MAY NOT NECESSARILY REQUIRE
EXPLICIT CONSENT FROM
INDIVIDUALS OR COMMUNITIES ABOUT
WHOM THAT DATA RELATE,
ESPECIALLY IN THE CASE OF THINGS
LIKE SYNTHETIC DATA, AND STUDIES
THAT USE LLM'S TRAINED ON
SYNTHETIC DATASETS ARE REALLY
UNLIKELY TO EVER RECEIVE FORMAL
ETHICS REVIEW OR APPROVAL, SO
WE'RE ESSENTIALLY TAKING OUT,
YOU KNOW, A HUGE SECTION OF
RESEARCH THAT WOULD OTHERWISE
UNDERGO SOME SORT OF ETHICS
OVERSIGHT FROM THE PIPELINE.
SO THE ASSOCIATIONS BETWEEN DATA
INPUTS AND OUTPUTS MAKE
POTENTIALLY SENSITIVE HEALTH
DATA INVOLVING PARTICIPANTS
RATHER RISKY WHEN WE USE THEM IN
THE CONDUCT OF RESEARCH.
SO IN LIGHT OF THOSE RISKS, THIS
IS A PAPER BY WATKINS THAT
REALLY PROVIDES WHAT SYNC A
HELPFUL GUIDE FOR RESEARCHERS
AND POTENTIALLY ALSO IRBS, LIKE
ABOUT THE ETHICAL ISSUES TO
CONSIDER WHEN USING LLM'S INTO
ACTUAL RESEARCH WORKFLOWS.
SO THEY WRITE ABOUT OR PROPOSE
THAT RESEARCHERS SHOULD ASK
QUESTIONS LIKE HOW TRAINING DATA
ARE MADE MORE TRANSPARENT TO
DATA CONTRIBUTORS AND USERS F
HOW LLM OUTPUTS WILL ENABLE
REPRODUCIBILITY STUDIES, AND
ASKING WHETHER THOSE OUTPUTS ARE
BEING TREATED IN A
NONANTHROPOMORPHIC MANNER, SO WE
HAVE A TENDENCY TO ASCRIBE A
SENSE OF AUTHORITY AND
LEGITIMACY TO NUMBERS AND
MACHINE-GENERATED OUTPUTS THAT
WE DON'T ALWAYS CONSIDER WHEN
THOSE OUTPUTS ARE BEING
GENERATED BY A HUMAN.
SO THERE'S A LOT OF REALLY
INTERESTING STS RESEARCH, SOCIAL
STUDIES SCIENCE RESEARCH LOOKING
AT THE AUTHORITY THAT'S GIVEN TO
OUTPUTS OF ALGORITHMS IN
COMPARISON TO HUMANS, AND I
WOULD BE REALLY HAPPY TO --
THAT'S A WHOLE ANOTHER TOPIC OF
CONVERSATION AND LOTS OF
SCHOLARS TO LOOK AT WHO ARE
DOING REALLY INTERESTING WORK IN
THAT REALM.
SO IT'S WORTH NOTING IN THIS
NEXT PHASE OF THE RESEARCH
PROCESS IN RESEARCH PEER REVIEW
THAT THE NIH RECENTLY RELEASED
AN OFFICIAL POSITION ON THE USE
OF LLM'S AND CHATGPT I THINK
REALLY THEIR COMMENTARY IS
DIRECTED AT CHATGPT, BAN BEING
THE USE OF THEM SPECIFICALLY IN
NIH PEER REVIEW.
SO THIS I THINK WAS REALLY AN
IMPORTANT POSITION TAKEN BY A
FEDERAL GRANTING AGENCY BECAUSE
GRANT APPLICATIONS AND CONTRACT
PROPOSAL MATERIALS ARE REALLY
PRIVILEGED INFORMATION THAT NIH
PROHIBITS FROM BEING SHARED OR
DISSEMINATED IN ANY MEANS
WHATSOEVER.
SO THE USE OF CHATGPT, THEY PUT
OUT IN THIS RELEASE, REALLY
VIOLATES THIS SHARING
PROHIBITION THAT THEY HAVE
BECAUSE IT REQUIRES SUBSTANTIAL
AND DETAILED INFORMATIONAL
INPUT.
SO THERE'S NO GUARANTEE OF WHERE
DATA ARE BEING SENT, SAVED, USED
OR HOW THAT DATA MIGHT BE USED
IN THE FUTURE BECAUSE ONCE WE
PROMPT CHATGPT WITH MAYBE SOME
SUPPORT WITH HOW AN APPLICATION
SHOULD BE REVIEWED OR EVALUATED,
WE HAVE NO IDEA KIND OF WHERE
THAT DATA END UP.
SO I THINK THAT NIH WAS VERY
WELL PLACED TO MAKE KIND OF THIS
BLANK EPT PROHIBITION ON CHAT GP
CHATGPT AND LLM'S IN THE PEER
REVIEW PROCESS.
SO I THINK WE'LL TALK BRIEFLY
ABOUT THE LIMITS OF IRB REVIEW
IN OVERSIGHTS.
WE TALKED A LITTLE BIT ABOUT IT
IN TERMS OF SYNTHETIC DATA, BUT
IT'S ALSO WORTH MENTIONING HOW
IRB'S ARE LIMITED IN THE SCOPE
OF THE REVIEWS FROM MANY
AI-BASED STUDIES, DUE IN PART TO
HOW ONE PART OF THE 4R5 CFR 46
IS INTERPRETED, REGARDING THE
LONG RANGE EFFECTS OF RESEARCH.
SO SOME OF MY COLLEAGUES
ALTHOUGH DAVID MAGNIS THE
ASTANFORD WRITE ABOUT THIS
SPECIFIC IRB LIMITATION IN THE
CON TESKS AI RESEARCH
GENERALLY -- CONTEXT OF AI
RESEARCH GENERALLY.
ONE INTERPRETATION IS QUESTIONS
WHETHER IRB'S CAN CONSIDER
THINGS LIKE GROUP HARMS OR LONG
RANGE EFFECTS OF AI RESEARCH AND
THE OUTPUTS THAT ARE GENERATED
BY AI RESEARCH UNDER THIS
PARTICULAR CLAWS.
SO I WOULD -- CLAWS, SO I WOULD
ALSO -- CLAUSE, SOILED ALSO
REFER PEOPLE TO HIS WORK IN
ESTABLISHING NEW ROLES OR TRYING
TO CHANGE ROLES FOR IRB'S IN THE
WAKE OF NEW HARMS AND BENEFITS
THAT AI REALLY POSES.
SO IN SOME IRB'S MAY BE LIMITED
IN THE DEGREE OF ETHICS
OVERSIGHT AND INTERVENTION THEY
CAN HAVE BECAUSE MANY STUDIES
THAT USE LLM TOOLS FALL OUTSIDE
THE DEFINITION OF HUMAN SUBJECTS
RESEARCH, MAYBE TO THE EXTENT
THEY'RE CONSIDERED HUMAN
SUBJECTS IRB'S ARE ALSO
INFREGHTLY STAFFED WITH
REQUISITE AI AND ML EXPERTISE
AND DATA PRIVACY EXPERTS TO
ASSESS AND ATEST THE BALANCING
OF THOSE REALISTIC HARMS AND
BENEFIT, AND I'M PART OF A GROUP
THAT HOLLY TAYLOR LEADS CALLED
THE AREA CONSORTIUM AND OUR
SMALL WORKING GROUP HAS STUDIED
THIS ISSUE OF IRB EXPERTISE AND
WHETHER AND WHEN THEY USE
EXTERNAL CONSULTANTS TO FILL IN
EXPERT GAPS IN THE REVIEW OF
CERTAIN PROTOCOLS AND DATA
PRIVACY AND AI WERE SPECIFICALLY
NOTED IN SOME OF THE INTERVIEWS
WE CONDUCTED WITH IRB MEMBERS
ACROSS THE COUNTRY ON THIS ISSUE
OF EXPERTISE AND MEMBERSHIP SHIP
EVE DISCUSSED THE TIME IR B'S
FACE WHEN REVIEWING RESEARCH BUT
WHAT ABOUT IRB'S OWN USE OF LLM?
I'VE BEEN REALLY INTERESTED IN
GROWING MOVEMENTS TOWARDS AND
TECHNOLOGICAL DEVELOPMENTS OF
AUTOMATED DECISION SUPPORT
SYSTEMS FOR ETHICS GOVERNANCE
AND I HAVE NAMELY LOOKED AND
RESEARCHED THIS IN THE CONTEXT
OF DATA ACCESS MANAGEMENT, BUT
THERE MIGHT BE CONCEIVABLE
APPLICATIONS OF LLM'S TO IRB
REVIEW.
SO COULD LLM'S BE USED TO MAYBE
SYN THINK SYNTHESIZE -- WITH
PRIOR PROTOCOLS TO ENSURE IRB
PRECEDENT AND COULD WE THEN
AUDIT IRB DECISIONS AND
HIGHLIGHT, YOU KNOW, ELEMENTS
THAT RATE WITHIN PROTOCOLS THAT
RAISE ETHICAL ISSUES TO ENSURE
THAT THOSE ARE BEING DECIDED ON
IN A CONSISTENT MANNER?
AS WE MENTIONED, LLM'S ARE
REALLY GREAT AT SCREENING AND
SYNTHESIZING, COULD THEY SCREEN
DOCUMENTS FOR READABILITY AND
COMPREHENSION AND POTENTIALLY
SIMULATE PARTICIPANT PERCEPTIONS
OF A STUDY AS A POINT OF
COMMUNITY MEMBERSHIP OR
COMMUNITY REVIEW, SO SOMETHING
TO CONSIDER IN TERMS OF AN
EMERGENT APPLICATION THERE MUCH
THE LAST PIECE WE'LL TALK ABOUT
IS DISSEMINATION AND DATA
SHARING, SO REALLY DATA SHARING
I SPEND A LOT OF MY ACADEMIC
RESEARCH TIME ON HOW WE MORE
WIDELY AND SECURELY SHARE DATA
AND IT'S NO SURPRISE THAT IT'S A
CORNERSTONE OF REALLY PROMOTING
RIGOROUS BIOMEDICAL RESEARCH AND
IT ENABLES BROADER POPULATION
INCLUSIVITY, REDUCES WASTE, CAN
AVOID DUPLICATION AND HELPS
FOSTER RICH SCIENTIFIC EXCHANGE.
SO FOR ALL THESE REASONS AND
MORE, THE NIH AND OTHER RESEARCH
AGENCIES LIKE IT MAKE DATA
SHARING A CONDITION OF RESEARCH
FUNDING.
SO THESE ARE JUST SOME EXAMPLES
OF RESEARCH FUNDERS, LARGE
RESEARCH FUNDERS AROUND THE
WORLD THAT HAVE, YOU KNOW,
EXPLICIT RULES AND POLICIES
AROUND SHARING DATA THAT STEM
FROM PROJECTS WITH FUNDING.
S ENTS RECENTLY THE WHITEHOUSE
OFFICE OF SCIENCE AND TECHNOLOGY
POLICY ANNOUNCED IT WOULD
MANDATE SHARING OF SCIENTIFIC
DATA STEMMING FROM FEDERALLY
FUNDED RESEARCH THAT IS OF
SUFFICIENT QUALITY TO VALIDATE
AND REPLICATE THE FINDINGS AND
TO MAKE THEM AVAILABLE TO THE
PUBLIC BY DEFAULT AT LEAST UPON
PUBLICATION.
SO MY COLLEAGUE KATE SPECTOR AT
THE UNIVERSITY OF MICHIGAN WROTE
IN A PIECE ELOQUENTLY ABOUT THE
IMPLICATIONS OF GENERATIVE AI
FOR THINGS LIKE DATA INTEGRITY,
THAT DATA SHARING AND THE
INTEGRITY OF THAT DATA AGAIN IS
REALLY THE BACKBONE OF THE
MEDICAL AND SCIENTIFIC RESEARCH
ENTERPRISE BUT WE'VE STRUGGLED
TO ENFORCE AND ENSURE STANDARDS
FOR THINGS LIKE VALIDITY,
REPRODUCIBILITY, TRANSPARENCY
AND REPLICABILITY AS IT IS.
SO I THINK THIS REALLY, YOU
KNOW, RAZORS AGAIN HOW SYNTHETIC
DATASETS GENERATED BY LLM'S CAN
BE SHARED AND COULD THEY EVER BE
SUFFICIENT QUALITY TO ENABLE
REPLICABILITY AS REQUIRED UNDER
THE NEW REGS.
AND I THINK I WOULD BE REMISS IF
I DIDN'T ALSO DRAW ATTENTION TO
A REALLY RECENT EXECUTIVE ORDER
THAT WAS RECENTLY RELEASED BY
PRESIDENT BIDEN ON SAFE, SECURE
AND TRUSTWORTHY AI.
SO WHILE NOT SPECIFIC TO DATA
SHARING PER SE, I WANTED TO TAKE
A MOMENT TO REVIEW THIS REALLY
SIGNIFICANT EVENT THAT HAPPENED
JUST TWO DAYS AGO AND HIGHLIGHT
SOME OF THE NEW STANDARDS THAT
WILL BE COMING DOWN THE
PIPELINE.
PRESIDENT BIDEN IS INVOKING THE
DEFENSE PRODUCTION ACT TO DO
KIND OF ALL OF THE FOLLOWING
THAT'S LISTED ON THIS SLIDE, AND
I'LL HIGHLIGHT JUST ONE BEFORE
WE GO TO QUESTIONS AND
DISCUSSION THAT I THINK WILL BE
OF PARTICULAR RELEVANCE TO
RESEARCHERS AND USERS OF
COMMERCIAL LLM'S, AND THAT'S
UNDER THE SUPPORT FOR CONSUMERS,
PATIENTS AND STUDENTS.
SO THE ORDER WILL COMPEL
COMPANIES AND DEVELOPERS TO TAG
AI-SUPPORTED OR GENERATED
CONTENT AND TO MAKE THAT CONTENT
TRANSPARENT TO USERS.
SO I THINK THAT'S OF PARTICULAR
RELEVANCE WHEN RESEARCHERS ARE
USING DIFFERENT TYPES OF LLM'S
ACROSS THE RESEARCH PROCESS.
SO I'M GOING TO LEAVE IT THERE
AND PERHAPS IN THE TIME WE HAVE
FOR DISCUSSIONS, WE'LL SHOW A
LIVE DEMONSTRATION OF -- THAT
HIGHLIGHTS HOW SOME OF THESE
TOPICS WE'VE TALKED ABOUT MIGHT
BE USED BY USING CHATGPT.
SO I'LL STOP SHARING NOW.
AND OPEN IT UP FOR QUESTIONS.
>> THANKS, VASO, BIG ROUND OF
APPLAUSE FROM YOUR EIGHT OR NINE
OF US WHO ARE IN PERSON.
WE HAVE THOSE IN PERSON WHO HAVE
MICS THAT THEY CAN ASK QUESTIONS
AND THEN I ALSO HAVE SOME
QUESTIONS FROM OUR VIRTUAL
AUDIENCE, BUT JASMINE IS AT THE
MIC AND SHE'S GOING TO ASK HER
FIRST QUESTION.
>> HI.
>> HI, JAZZ ZION THANKS FOR
THIS.
SO I THOUGHT THIS SYNTHETIC DATA
BIT THAT YOU WERE TALKING ABOUT
WAS REALLY FASCINATING.
AND I WAS HOPING YOU COULD TALK
A LITTLE BIT MORE ABOUT THAT.
SPECIFICALLY, I'M INTERESTED IN
LIKE SYNTHETIC DATA WAS KIND OF
A STRIKING NAME, AND FROM A LOT
OF YOUR DISCUSSION OF IT, IT
REALLY SOUNDS MORE LIKE IT'S
LIKE MODELING OR SOMETHING.
SO I GUESS IN WHAT SENSE DO YOU
THINK IT REALLY IS DATA, AND DO
YOU THINK THAT'S LIKE A
DELIBERATE MISNOMER, OR DO YOU
THINK IT'S LIKE ACCURATE AND
FAIR IN SOME WAYS?
I WOULD LOVE TO HEAR A LITTLE
BIT MORE ABOUT THAT.
>> ALL REALLY PRESS AND GO
RECURRING QUESTIONS THAT I ASK
MYSELF THE SAME THING, JASMINE.
I THINK THE SYNTHETIC PART IS A
BIT OF A MISNOMER BECAUSE IT
ASSUMES THAT, YOU KNOW, THIS
DATA HAS NO RELEVANCE TO
INDIVIDUAL PEOPLE OR COMMUNITIES
OR PHENOMENON, AND SO I THINK
FROM THAT RESPECT, YOU KNOW,
PEOPLE HAVE THIS I THINK
INCORRECT OR FALSE SENSE OF
SECURITY THAT IT WILL BE ABLE TO
CIRCUMVENT ALL OUR PRIVACY AND
CONFIDENTIALITY ISSUES, WHEN
THAT'S NOT NECESSARILY THE CASE.
I DO THINK IT IS DATA AND I
THINK THIS IS SORT OF A LARGER
ALMOST PHILOSOPHY OF SCIENCE
QUESTION ABOUT WHAT IS DATA, BUT
I THINK, YOU KNOW, DATA THAT ARE
REPRESENTATIVE OF PHENOMENON,
THAT'S HOW I BROADLY CONSTRUE
WHAT DATA ARE, THAT I THINK IT
IS STILL CONSIDERED DATA, BUT I
WORRY ABOUT HOW IT -- IT DOES
INNATELY FALL UNDER THE
REGULATORY REQUIREMENTS FOR DATA
AS THEY CURRENTLY EXIST, AND I
THINK WILL BE USED TO, YOU KNOW,
CIRCUMVENT ETHICAL OVERSIGHT
PROCESSES LIKE IRB REVIEW, LIKE
HIPAA WHEN, YOU KNOW, THERE MAY
STILL BE THREATS THAT BOTH OF
THOSE SAFEGUARDS ARE IMPLEMENTED
TO HELP PROTECT.
SO THIS IS A REALLY EVOLVING
QUESTION AND ISSUE AND CERTAINLY
NOT ONE THAT I THINK IRB'S AND
TRADITIONAL INSTITUTIONAL ETHICS
OVERSIGHT BODIES HAVE
ENCOUNTERED BEFORE.
>> THANK YOU.
>> THANKS.
WE HAVE CHLOE ALSO HERE IN THE
AUDITORIUM.
>> I ALSO HAVE A CLARIFYING
QUESTION ON THE SYNTHETIC DATA.
I THOUGHT IT WAS REALLY
INTERESTING HEARING YOUR
PERSPECTIVE.
BUT I DON'T REALLY SEE HOW IT'S
THAT NOVEL BECAUSE TO ME, IT
SEEMS LIKE THE SAME THING IS
BOOTSTRAPPING AND LIKE IS
THERE -- ARE THERE MORE AVENUES
FOR SYSTEMATIC BIAS TO CREEP IN
THAT WE CAN'T DETECT RS OR IS IT
KIND OF THE SAME AS
BOOTSTRAPPING WHERE AS LONG AS
THE INITIAL SAMPLE IS ALL RIGHT,
THERE'S NOT REALLY THAT MANY
AVENUES FOR MORE BIAS?
>> I THINK IT'S I'VE GREAT
OBSERVATION, AND THE ONE WAY
THAT I THINK IT COULD BE
DIFFERENT IS THERE'S SOME
SCHOLARS WHO ARE TALKING ABOUT
THE POSSIBILITY OF THERE BEING A
SYNTHETIC DATA COLLAPSE, SO AT
SOME POINT IN THE LEARNING
PROCESS, YOU ARE FEEDING, YOU
KNOW, NEW INPUTS, YOU'RE
GENERATING BETTER REFINED
OUTPUTS, BUT IF THOSE INPUTS ARE
FROM AI-GENERATED CONTENT
ITSELF, YOU CAN IMAGINE THIS
KIND OF CIRCUITOUS LOOP OF
AI-GENERATED CONTENT BEING FED
IN AND AI-GENERATED CONTENT
BEING FED OUT AND ALTHOUGH SOME
POINT IT WILL CREATE A
COLLAPSE -- AND AT SOME POINT IT
WILL CREATE A COLLAPSE OF THE
WHOLE MODEL AND THE WHOLE
SYSTEM, SO I THINK IN THIS THAT
WAY THIS PHENOMENON OF COLLAPSE
IS DIFFERENT THAN BOOTSTRAPPING
AND I THINK POSES A GREATER
THREAT TO, YOU KNOW, RIGOR AND
REPRODUCIBILITY THAT
BOOTSTRAPPING CAN ACTUALLY,
BECAUSE IT'S HUMAN SUPERVISED
AND OVERSEEN, THAT IT CAN
OVERCOME BETTER THAN SYNTHETIC
DATA.
SO I THINK IN ONE WAY, THAT'S
ONE ASPECT, I THINK IT'S A
LITTLE BIT DIFFERENT.
BUT YOU'RE RIGHT TO SAY THAT
COMPUTATIONALLY THIS IS A
SIMILAR IDEA, BUT THAT BECAUSE
THERE'S LESS HUMAN INTERVENTION,
THIS COLLAPSE SPROB A REAL
ISSUE.
-- COLLAPSE PROBLEM IS A REAL
ISSUE.
>> THANK YOU.
SYNTHETIC TOUCHED A LOT OF
NERVES, I GUESS, SO WE HAVE A
QUESTION FROM LAURA HERE.
YOU MENTIONED SYNTHETIC DATA CAN
BE USED TO CONTROL FOR BIASES.
CONSIDERING, HOWEVER, THAT A LOT
OF REAL WORLD DATA CAN BE SKEWED
TOWARDS WHITE SUBJECTS, FOR
EXAMPLE, STLINLT A RISK OF EX-S
A -- STLINT A RISK OF EX---
ISN'T THERE A RISK OF EXACERBATE
ING --
>> I THINK EXACERBATION COMES
FROM RESEARCHERS AND THOSE
CONDUCTING THE RESEARCH TO NOT
THINK THAT REPRESENTATION IS A
HALLMARK OF RIGOROUS RESEARCH.
SO I THINK, YOU KNOW, WHAT
SYNTHETIC DATA TRIES TO DO IS IT
ACKNOWLEDGES THOSE MISSING DATA
OR UNDERREPRESENTATIONS AT THE
FIRST INSTANCE AND TRIES TO
MITIGATE BY OVERSAMPLING OR BY,
YOU KNOW, FITTING THE DATA WITH
MORE DIVERSE DATA POINTS.
SO I THINK THERE'S CERTAINLY AN
OPPORTUNITY FOR BIAS TO BE
EXACERBATED WHEN DIVERSITY ISN'T
A PRIORITY AMONG RESEARCHERS AND
THOSE WHO, YOU KNOW, ARE
COMMITTED TO CONVENIENCE
SAMPLING AND FITTING DATA THAT
WILL EVENTUALLY COME TO THE
ANSWER THAT RESEARCHERS WANT.
SO I THINK THE SAME ISSUE OF
OVERFITTING AND NOT RECOGNIZING
THE IMPORTANCE OF DIVERSITY IN
THE DATASET STILL REMAINS,
WHETHER YOU USE SYNTHETIC DATA
OR REAL WORLD DATA.
SO IT'S ABSOLUTELY AN IMPORTANT
POINT.
>> GREAT.
A COUPLE OTHER QUESTIONS FROM
OUR VIRTUAL AUDIENCE.
SO ONE, THEY'RE BOTH A LITTLE
MORE, I'LL CALL THEM A LITTLE
MORE PHILOSOPHICAL, AND I KNOW
YOU'RE UP FOR THAT.
THE FIRST ONE IS, IN TERMS OF
ORIGINALITY AND GENERATIVE AI,
MOST OF THE TIMES I FIND AI
IDEAS, QUOTE, UNQUOTE, TO BE
PREDICTABLE AND SOMETIMES
INFERIOR TO HUMAN-GENERATED
IDEAS, UNLESS THE HUMAN IS
OVERWORKED AND OVERSTRESSED.
IN A WORLD WHERE AI IS USED
OFTEN TO ACCELERATE OUTPUT,
BURNOUT MIGHT BE MORE LIKELY TO
OCCUR, THUS POTENTIALLY INCREASE
BEING OUR DEPENDENCY ON AI.
ARE WE POTENTIALLY CREATING A
POSITIVE FEEDBACK LOOP THAT
MAKES US MORE DEPENDENT?
>> IT'S ALMOST LUNCHTIME.
>> YES, I KNOW, EXACTLY RIGHT.
A FEEDBACK LOOP THAT MAKES US
MORE DEPENDENT ON AI.
>> IT IS A PHILOSOPHICAL
QUESTION ABOUT THE NATURE OF
LABOR, I THINK VERCH A TYPE OF
LABOR -- VERCH A TYPE OF
LABOR -- RESEARCH IS A TYPE OF
LABOR, INTELLECTUAL LABOR, AND
OUR DEMAND FOR AI IS EXACTLY
REPRESENTATIVE OF THE NEEDS WE
SEE IN OUR EVERYDAY LIFEMENT SO,
YOU KNOW, THE THREAT OF BURNOUT,
THE THREAT OF INCENTIVES THAT
INSTITUTIONS AND RESEARCH
STRUCTURES, YOU KNOW, IMPOSE ON
THOSE OF US TO CONTINUOUSLY
INNOVATE, TO COME UP WITH NOVEL
RESEARCH IDEAS, THAT'S I THINK
WHAT DRIVES PEOPLE OR
INCENTIVIZES PEOPLE TO LOOK FOR
WAYS TO IMPROVE EFFICIENCY AND
TO GENERATE THESE PRODUCTS THAT
WE'RE OBVIOUSLY REWARDED BY,
THING LIKE PUBLICATION,
PROMOTION, ET CETERA.
SO I ABSOLUTELY THINK THAT
CONSIDERING RESEARCH AS A TYPE
OF HUMAN LABOR, WHICH AI CAN
HELP OVERCOME, YOU KNOW,
RATE-LIMITING STEPS AND THE
REASONS FOR WHY WE INTEGRATE AI
INTO DIFFERENT WORKFLOWS IS A
DIRECT COMMENTARY ON AREAS OF,
YOU KNOW, OUR CURRENT LABOR THAT
WE WEREN'T ABLE TO MEET OR WE
STRUGGLE TO MEET.
AND THOSE ARE ENVIRONMENTAL AND
SOCIAL CONDITIONS, IN MY
PERSPECTIVE.
BUT IT'S FOR SURE I THINK
REMINISCENT OF THIS LARGER
PHILOSOPHICAL QUESTION ABOUT
WHAT IS LABOR, HUMAN LABOR, AND
HOW CAN AI SUPPORT SOME OF THE
REDUNDANCIES IN HUMAN LABOR
WHILE FREEING UP THE MIND TO
DO -- THE HUMAN MIND WHAT IT
DOES BEST, WHICH I THINK IS
INNOVATE AND CREATE AND BE NOSM.
BUT I LOVE THE QUESTION -- AND
BE NOVEL.
BUT I LOVE THE QUESTION, AND I
WOULD WELCOME ANY TYPE OF
COLLABORATION THAT HELPS TO
EXPLORE IT A LITTLE BIT FURTHER.
>> MORE FOOD FOR THOUGHT IN THAT
CASE.
>> MORE FOOD FOR THOUGHT.
>> OKAY.
SO WE'LL TAKE THIS ONE LAST
QUESTION.
COULD YOU TALK -- THIS IS FROM
MICHAEL.
COULD YOU TALK A BIT MORE ABOUT
THE SUBJECT OF ORIGINALITY IN
REGARDS TO AI AND HUMAN RESEARCH
PROCESS GENERATION -- RESEARCH
PROCESS GENERATION?
IF THE LLM'S ARE AT THE MOMENT
PARROTING, QUOTE, UNQUOTE,
EXISTING INFORMATION, HOW COULD
IT GENERATE NEW RESEARCH
QUESTIONS?
YEAH, THIS IS THE EXACT
QUESTION I ASK MYSELF, AND EVEN
STEPPING BACK, IS ORIGINALITY A
NOVELTY NECESSARY IN THE
RESEARCH PROCESS?
AND SO I THINK TO THE EXTENT
THAT YOU PROMPT LLM'S TO, YOU
KNOW, SUMMATE INFORMATION OR
SYNTHESIZE INFORMATION, YOU
KNOW, THERE ARE DIFFERENT TASKS
YOU CAN POSE LLM'S TO DO.
SO I THINK IN A CERTAIN CONTEXT,
YOU COULD HAVE AN LLM, YOU KNOW,
SUMMARIZE AN ENTIRE FIELD OF
RESEARCH, AND THAT SUMMARY HELPS
YOU, AS I SAID, IDENTIFY CERTAIN
GAPS THAT ARE RELEVANT OR WITHIN
YOUR OWN RESEARCH CONTEXT BE
ABLE TO APPLY THAT SYNTHESIS AS
SORT OF A LAUNCH POINT FOR
SOMETHING ELSE.
SO I THINK IT IS NOVEL IN THE
SENSE THAT IT HELPS PUT PEN TO
PAPER, WHICH IS SOMETIMES A
RATE-LIMITING STEP IN THE
RESEARCH PROCESS, WHETHER IT CAN
GENERATE ENTIRELY NEW IDEAS
THEMSELVES, NO, FOR THE EXACT
REASONS YOU'RE SAYING, BUT I
THINK WHEN PAIRED WITH THE HUMAN
MIND, THAT'S WHEN THE NOVELTY
AND ORIGINALITY OCCURS.
BUT THIS FUNDAMENTAL QUESTION
ABOUT WHETHER ORIGINALITY IS
NECESSARY TO BE GOOD RESEARCH I
THINK IS ALSO A PHILOSOPHICAL
QUESTION THAT WARRANTS
REFLECTION.
>> GREAT.
WELL, WE'LL LEAVE IT AT THAT.
THANK YOU SO MUCH FOR JOINING
US.
SORRY IT COULDN'T BE IN PERSON.
[APPLAUSE]
>> ME TOO.
>> NEXT TIME.
WHEN WE HAVE YOU BACK TO TALK
ABOUT SPACE SCIENCE.
>> YES.
AND SYNTHETIC DATA IN SPACE, HOW
ABOUT THAT?
>> OH, THAT SOUNDS AWESOME.
SO THANK YOU AGAIN, AND WE'LL BE
IN TOUCH ABOUT THIS AFTERNOON.
VERY GOOD.
GOOD.
AND THANKS TO ALL OF YOU WHO ARE
HERE AND YOU AOF THOSE IN THE
VIRTUAL AUDIENCE FOR
PARTICIPATING THIS YEAR.
IT'S BEEN A GREAT OPPORTUNITY
FOR ME.
I LEASHED A TON -- I LEARNED A
TON.
AND FIP INITIAL UP THOSE QUIZZES
BY THE FIFTEENTH OF NOVEMBER -- BE SENDING OUT YOUR CERTIFICATES