WELCOME, EVERYONE, TO SESSION
SIX.
TODAY IS INTERNATIONAL DAY,
WHICH I AM ALWAYS VERY EXCITED
ABOUT.
I HAVE A COUPLE OF QUICK
ANNOUNCEMENTS.
THE FIRST IS THAT THE WORD OF
THE DAY TODAY IS KENYA, I'LL TRY
TO REPEAT THAT, AND AS WE GO
FORWARD.
WE'RE GOING TO HAVE THREE
SPEAKERS TODAY.
WE'RE GOING TO START WITH
ANNETTE RID WHO I'LL INTRODUCE
IN A MOMENT FOLLOWED BY JOE
MILLUM WHO WILL BE TALKING ABOUT
POST-TRIAL OBLIGATIONS, AND THEN
DORCAS KAMUYA, WHO WILL BE
TALKING ABOUT COMMUNITY
ENGAGEMENT IN HEALTH RESEARCH,
WHY IT MATTERS, AND DIFFERENT
APPROACHES.
I ALSO WANT TO LET YOU KNOW THAT
DURING DR. KAMUYA'S
PRESENTATION, WE'RE GOING TO BE
USING SLIDO.
I SENT OUT AN EMAIL TO
EVERYBODY.
WHAT YOU NEED DO IS GO TO
SLIDO.COM, AND I WILL REPEAT THE
NUMBER WHEN WE GET TO DORCAS'
LECTURE, BUT ALL THE INFORMATION
IS IN THE EMAIL AND THERE'S ALSO
A LINK IN THE EMAIL.
PLEASE WAIT TO POST YOUR
RESPONSES.
I KNOW SOME OF YOU ARE ALREADY
POSTING IN THE DISCUSSION
SECTION.
IT'S HARD FOR ME TO MANAGE
MULTIPLE OPTIONS AT THE SAME
TIME, SO PLEASE REPEAT YOUR
RESPONSES IN SLIDO AND/OR WAIT
AND PUT YOUR RESPONSES INTO
SLIDO.
SO WITH THAT, I'M GOING TO
INTRODUCE OUR FIRST SPEAKER,
ANNETTE RID, A MEMBER OF OUR
DEPARTMENT IN THE CLINICAL
CENTER, THE DEPARTMENT OF
BIOETHICS, AND IS ALSO THE
LIAISON WITH THE NIH FOGARTY
INTERNATIONAL CENTER, WHERE SHE
PROVIDES ETHICS, CONSULTATION
AND EDUCATION SUPPORT.
HER RESEARCH INTERESTS SPAN
RESEARCH ETHICS, GLOBAL HEALTH,
JUSTICE AND HEALTH, ALL SORTS OF
THINGS THAT ARE IMPORTANT, AND
SHE IS GOING TO SHARE TODAY AN
INTRODUCTION TO INTERNATIONAL
RESEARCH ETHICS AS WELL AS AN
INTRODUCTION TO THE CONCEPT OF
STANDARDS OF CARE.
SO TAKE IT AWAY.
>> THANK YOU SO MUCH, HOLLY.
GOOD MORNING TO EVERYONE IN THE
ROOM.
GOOD MORNING, GOOD DAY, GOOD
EVENING TO EVERYONE WHO'S
WATCHING ONLINE.
IT'S A PLEASURE TO SPEAK TO YOU
TODAY ABOUT FIRST SOME GENERAL
THOUGHTS ABOUT INTERNATIONAL
RESEARCH ETHICS AND THEN
STANDARDS OF CARE.
YOU SHOULD NOTE THAT WHAT I SAY
DOES NOT REFLECT THE VIEWS OF
THE U.S. GOVERNMENT, IT REFLECTS
MY OWN VIEWS.
I ALSO WANT TO NOTE THAT I USE
THE TERM -- WILL BE USING SINCE
WE'RE TALKING ABOUT AN
INTERNATIONAL CONTEXT, WILL BE
USING THE TERMS LOW INCOME TU
TRIES AND MIDDLE INCOME
COUNTRIES.
USING THESE TERMS I DO NOT WISH
TO SUGGEST THERE'S A HIERARCHY
OF COUNTRIES AND I ALSO
RECOGNIZE THERE'S HUGE DIVERSITY
BETWEEN BOTH GROUPS OF
COUNTRIES, SOCIALLY,
HISTORICALLY, CULTURALLY AND SO
ON.
SO I WANT TO START OUT WITH MY
OVERVIEW OF WHAT I THINK IS
UNIQUE ABOUT INTERNATIONAL
RESEARCH ETHICS, AND WE'LL BE
FOCUSING ON -- TODAY OUR
SESSIONS WILL BE FOCUSING ON
INTERNATIONAL COLLABORATIVE
RESEARCH, WHICH I UNDERSTAND IS
RESEARCH THAT IS SPONSORED BY
INSTITUTIONS IN HIGH INCOME
COUNTRIES AND THEN CONDUCTED IN
LOW/MIDDLE INCOME COUNTRIES IN
COLLABORATION WITH RESEARCHERS
THERE.
I THINK THIS KIND OF RESEARCH
HAPPENS IN A VERY UNIQUE CONTEXT
THAT HAS REALLY IMPORTANT
IMPLICATIONS FOR WHAT
INVESTIGATORS AND SPONSORS OWE
TO PARTICIPANTS, BUT ALSO FOR
THE COLLABORATION BETWEEN THE
RESEARCHERS.
SO TO GET US THINKING, I WOULD
LIKE TO INTRODUCE A LITTLE
VIGNETTE OF THE MOTHER TO
OFFSPRING MALARIA STUDY.
THIS IS A STUDY THAT HAPPENED IN
THE EARLY 2000s IN TANZANIA,
WAS SPONSORED BY NIH AND SOME
OTHER SPONSORS IN HIGH INCOME
COUNTRIES.
THE GOAL WAS TO LEARN ABOUT
MALARIA INFECTION IN EARLY LIFE,
MAINLY FROM A GENOMIC
PERSPECTIVE.
AND IT INVOLVED ENROLLING
PREGNANT PEOPLE INTO RESEARCH
AND THEN FOLLOWING THEM AS WELL
AS THEIR INFANTS FOR UP TO --
THEN WERE CHILDREN -- UP TO FIVE
YEARS AND TAKING VERY
FREQUENT -- IN ORDER TO MONITOR
THEIR INFECTION IN ORDER TO GET
INFORMATION ABOUT THE MALARIA
PARASITES, YOU KNOW, WHAT THEIR
GENOMICS WAS AND SO ON.
THIS STUDY EXPECTED, BECAUSE IT
WAS BASICALLY LOOKING AT WHETHER
THE ENROLLED PEOPLE HAD MALARIA
WAS EXPECTING TO DIAGNOSE
MALARIA, AND THEREFORE MADE
PLANS TO TREAT PARTICIPANTS FOR
MALARIA.
HOWEVER, MALARIA ALSO TRAVELS
WITH OTHER INFECTIOUS DISEASES,
AND THEREFORE THEY WERE
EXPECTING TO DIAGNOSE A RANGE OF
OTHER DISEASES.
INCLUDING HIV, WHICH WAS AT THE
TIME IN THE EARLY 2000s A
REALLY IMPORTANT HEALTH ISSUE
BECAUSE HIV ANTIRETROVIRAL
TREATMENT HAD NOT BEEN YET
SCALED UP IN LOW/MIDDLE INCOME
COUNTRIES, SO BECAUSE THEY
EXPECTED THAT THEY WOULD BE
DIAGNOSING HIV UNFORTUNATELY IN
SOME OF THE PARTICIPANTS, AND
THEY WANTED TO BE PREPARED, THEY
ALSO COULD NOT OFFER A FULL
RANGE OF HIV SERVICES, AGAIN,
HIV -- ANTIRETROVIRAL TREATMENT
AT THE TIME WAS NOT YET
AVAILABLE, SO THEY DECIDED TO
TAKE WHAT THEY THOUGHT WAS A
FEASIBLE APPROACH, WHICH WAS
THAT THEY WOULD BE ABLE TO TREAT
IN PARTICULAR THE SMALL CHILDREN
WITH PROPHYLAXIS FOR HIV-RELATED
INFECTIONS, AND THEN IF THOSE
INFECTIONS BECAME DIFFICULT TO
TREAT, REFER THEM TO HOSPICE
CARE IN THE CASE OF SERIOUS
HIV-RELATED ILLNESS.
SO THIS STUDY, I THINK
ILLUSTRATES A NUMBER OF THINGS
ABOUT THE PARTICULAR CONTEXT.
NOT THE WHOLE RANGE BUT A NUMBER
OF THINGS ABOUT THE PARTICULAR
CONTEXT THAT IS THE CONTEXT OF
INTERNATIONAL RESEARCH.
AND I LIKE TO THINK ABOUT THE
CONTEXT IN THREE WAYS.
I THINK FIRST OF ALL, THIS
CONTEXT IS UNIQUE BECAUSE
THERE'S A REALLY DIVERSE RANGE
OF ACTORS, AND THERE ARE BIG
CULTURAL DIFFERENCES BETWEEN
THESE ACTORS.
THAT'S BOTH BETWEEN THE
RESEARCHERS BUT ALSO BETWEEN THE
COMMUNITIES.
SO DIFFERENT SYSTEMS OF MEANING
THAT INFLUENCE AND VALUE AND
SOCIAL NORMS THAT INFLUENCE
EXPECTATIONS AND IDEAS ABOUT
RESEARCH, WHAT RESEARCH SHOULD
BE CONDUCTED AND HOW IN THIS
SETTING.
SECOND, I THINK THEY'RE REALLY
IMPORTANT POWER DIFFERENTIALS
BECAUSE THE RESEARCH IS
SPONSORED IN MANY CASES AND THIS
IS THE FOCUS TODAY, FROM
INSTITUTIONS IN HIGH INCOME
COUNTRIES, SO THERE'S
DISCREPANCY IN FINANCIAL
RESOURCES, BUT THERE'S ALSO
DIFFERENT TRAINING OPPORTUNITIES
FOR RESEARCHERS IN HIGH INCOME
COUNTRIES THAN IN LOW/MIDDLE
INCOME COUNTRIES SO POWER
DIFFERENTIALS BETWEEN THE
RESEARCHERS BUT ALSO BETWEEN THE
COMMUNITIES.
AND THEN THIRDLY, THERE IS A
CONTEXT OF BACKGROUND INJUSTICE.
BY THAT I MEAN THERE ARE
EXISTING INJUSTICES DUE TO
COLONIAL HISTORY, THE CURRENT
WORLD ORDER, FAILURES, SORT OF
GOVERNMENT FAILURES AT THE LOCAL
LEVEL AND SO ON THAT MEAN THAT
THE BASIC INSTITUTIONS IN
SOCIETIES IN LOW/MIDDLE-INCOME
COUNTRIES OFTEN DO NOT FUNCTION
IN A WAY THAT ALLOWS EVERYONE TO
MEET THEIR BASIC NEEDS.
SO YOU HAVE LOTS OF PEOPLE WHO,
LIKE, SHELTER, ADEQUATE
NUTRITION, ACCESS TO CLEAN WATER
AND SO ON.
AND THIS CREATES NOT ONLY NEEDS
BUT ALSO AS A CONTEXT IN WHICH
PEOPLE'S RIGHTS ARE OFTEN
VIOLATED.
RESEARCHERS ARE NOT PERSONALLY
RESPONSIBLE, OF COURSE, FOR THAT
EXISTING BACKGROUND INJUSTICE
THAT THEY MIGHT FIND, BUT I
THINK IT HAS IMPORTANT
IMPLICATIONS FOR WHAT THEY
SHOULD DO AND HOW THEY SHOULD
RESPOND TO IT, PARTLY BECAUSE
THEY'RE PARTLY IMPLICATED IN
SOME OF THESE INJUSTICES AND
PARTLY BECAUSE, YOU KNOW,
THEY'RE JUST REALLY MASSIVE --
THERE ARE REALLY JUST MASSIVE
NEEDS THAT THEY'RE IN A POSITION
TO RESPOND TO.
SO HOW DOES THAT PLAY OUT?
IF WE THINK OF EACH OF THESE?
FOR THE CULTURAL DIFFERENCES,
THINK AGAIN ABOUT THE MALARIA
STUDY, COMMUNICATING WHAT THE
STUDY WAS ABOUT DURING THE
INFORMED CONSENT PROCESS BUT
ALSO ENGAGING THE COMMUNITY, WAS
THIS A WORTHWHILE STUDY TO DO.
LOTS OF SORT OF DIFFERENCES IN
TERMS OF HOW PEOPLE MIGHT THINK
ABOUT THIS KIND OF RESEARCH THAT
COULD EXIST HERE IN THIS SETT
SETTING.
SECOND, IMPORTANT POWER
DIFFERENTIALS.
SO THINK OF A PREGNANT PERSON
WHO'S CONSIDERING ENROLLING AND
MAYBE DOES NOT HAVE ACCESS TO
OTHER WAYS OF DIAGNOSING
MALARIA.
ARE THEY GOING TO BE REALLY --
FEEL FREE TO REALLY, YOU KNOW,
NOT ENROLL IN THIS STUDY?
BUT SIMILARLY, YOU CAN ASK A
SIMILAR QUESTION AT THE
COMMUNITY LEVEL, COMMUNITIES WHO
ARE BEING ASKED TO PARTICIPATE
IN SUCH RESEARCH, THE RESEARCH
WILL BRING RESOURCES TO THEM, IS
THAT LIKE -- WHAT ARE SORT OF
THE POWER DYNAMICS OF
NEGOTIATING THAT ACCESS TO
COMMUNITIES.
SIMILAR WITH INDEPENDENT ETHICS
REVIEW, AND THEN WORKING OUT AT
THE LEVEL OF THE COLLABORATION
BETWEEN THE INVESTIGATORS, WHAT
EQUITABLE PARTNERSHIP MEANS IN
THAT CONTEXT GIVEN THAT THERE IS
THIS DIFFERENCE NOT JUST IN
FINANCIAL RESOURCES BUT ALSO
ACADEMIC RESOURCES.
AND THEN THIRDLY, WITH REGARD TO
THE BACKGROUND INJUSTICES, YOU
KNOW, ONE QUESTION IS, DOES THE
RESEARCH THAT HIGH INCOME
COUNTRIES SPONSOR AND
LOW/MIDDLE-INCOME COUNTRIES, IS
THAT ONLY ACCEPTABLE WHEN IT
TRIES TO ADDRESS SORT OF THOSE
BACKGROUND INJUSTICES.
ADDRESS CHALLENGES THAT OCCUR
LOCALLY AND HELP TO IMPROVE
HEALTH GLOBALLY AND REDUCE
GLOBAL HEALTH INEQUITIES.
SO LOTS OF REALLY INTERESTING
QUESTIONS AROUND THAT, IMPORTANT
QUESTIONS AROUND THAT, WHEN IS
RESEARCH ACTUALLY RESPONSIVE, SO
MALARIA OBVIOUSLY IS RESPONSIVE
BECAUSE IT IS A BIG PROBLEM, BUT
YOU COULD ASK A QUESTION
WHETHER, YOU KNOW, A STUDY THAT
WAS INTENDED TO LAY THE
FOUNDATION FOR SORT OF GENOMIC
APPROACHES THAT SEEM QUITE
DISTANT PERHAPS IN APPLICATION,
WHETHER THAT IS SORT OF THE
BIGGEST PRIORITY.
NOT TO SAY THAT IT WOULD BE
ETHICALLY UNACCEPTABLE, BUT IS
THAT THE BIGGEST PRIORITY.
IMAGINE A VERSION OF A STUDY,
THIS ONE I'M JUST MAKING UP, BUT
IMAGINE A STUDY WHERE
INVESTIGATORS COME TO TEST A
MALARIA VACCINE THAT IS AIMED AT
THE HIGH INCOME COUNTRY TRAVELER
MARKET, NOT LOW/MIDDLE-INCOME
COUNTRIES, BUT THEY'RE TESTING
IT THERE BECAUSE MALARIA IS
REALLY FREQUENT OBVIOUSLY IN
COUNTRIES WHERE IT IS ENDEMIC.
THAT RESEARCH IS NOT REALLY
RESPONSIVE TO LOCAL HEALTH
NEEDS, BUT YOU KNOW, AND SO IS
THAT AN ACCEPTABLE STUDY TO DO,
IF SO, UNDER WHAT CONDITIONS.
SO LOTS OF QUESTIONS AROUND THE
KIND OF RESEARCH BEING
CONDUCTED, BUT THEN ALSO HOW
THAT RESEARCH SHOULD BE
CONDUCTED.
I'LL BE FOCUSING MORE ON
STANDARDS OF CARE FOR THE REST
OF MY TALK, BUT ANS L AN ANCILL,
YOU SAW IN THE MALARIA STUDY,
THEY DECIDED TO GIVE RELATIVELY
LIMITED CARE FOR HIV-RELATED
OPPORTUNISTIC INFECTIONS, BUT
SURELY THEY COULD HAVE DONE
MORE.
SURELY THERE WILL BE OTHER
CONDITIONS THAT THEY WILL BE
DIAGNOSING AS PART OF THE
RESEARCH, AND REALLY IMPORTANT
QUESTIONS HOW TO RESPOND TO
THOSE.
BECAUSE, OF COURSE, THE MAIN
ROLE OF THE RESEARCH IS TO
CONDUCT RESEARCH AND NOT TO
PROVIDE CARE.
THEY'RE NOT HEALTHCARE
PROVIDERS.
YET THEY SEEM TO HAVE -- YOU
KNOW, THERE'S A REALLY STRONG
INTUITION THEY SHOULD BE DOING
SOMETHING ABOUT THE CONDITIONS
THAT THEY SEE.
SO REALLY IMPORTANT QUESTIONS
ABOUT THESE OBLIGATIONS WITH
RESPECT TO ANCILLARY CARE THAT
IS CONDITIONS THAT ARE NOT
RELATED TO THE STUDY BUT
NONETHELESS HAVE REALLY
IMPORTANT HEALTH IMPLICATIONS
FOR THE PARTICIPANTS.
AND THEN POST STUDY OBLIGATIONS.
WE HAVE SYSTEMS IN HIGH INCOME
COUNTRIES, HOWEVER IMPERFECT,
THAT MEAN THAT WHEN RESEARCH IS
CONDUCTED AND IT SHOWS THAT AN
INTERVENTION IS SAFE AND
EFFECTIVE, IT WILL MAKE ITSELF
INTO THE MARKET.
THAT'S WHY PEOPLE DO THE
RESEARCH, LAKE T LIKE THEY WILLT
LICENSURE AND IT WILL BE
MARKETED.
SO STUDIES, THE POPULATIONS AND
THE PARTICIPANTS WILL EVENTUALLY
GET ACCESS TO THESE
INTERVENTIONS.
THAT IS LESS THE CASE IN
COUNTRIES THAT DON'T HAVE AS
MUCH MONEY AT THEIR DISPOSAL FOR
HEALTHCARE, SO NEW INNOVATIONS
ARE OFTEN VERY LATE TO COME IF
THEY COME AT ALL IN
LOW/MIDDLE-INCOME COUNTRIES, AND
THERE'S REALLY IMPORTANT
QUESTIONS AROUND POST-STUDY
OBLIGATIONS BOTH TO INDIVIDUAL
PARTICIPANTS OF WHAT HAPPENS
WHEN THE STUDY IS OVER, TO THOSE
PARTICIPANTS, AND THEY, SAY, DO
NOT HAVE CONTINUITY OF CARE
BECAUSE THE HEALTHCARE
INFRASTRUCTURE LOCALLY IS
SUBOPTIMAL.
OR ALSO AT THE POPULATION LEVEL.
I'VE HIGHLIGHTED A COUPLE OF
THESE TOPICS, I THINK BECAUSE
THESE ARE THE ONES THAT WE'LL BE
TALKING ABOUT IN MORE DETAIL
TODAY.
HOLLY ALREADY MENTIONED JOE
MILLUM WILL BE TALKING ABOUT
POST STUDY OBLIGATIONS, AND I
WILL BE TALKING ABOUT STANDARD
OF CARE NOW AND DORCAS KAMUYA IS
GOING TO SPEAK ABOUT COMMUNITY
ENGAGEMENT.
SO WITH THAT OVERVIEW OF SORT OF
THE CONTEXT OF INTERNATIONAL
RESEARCH ETHICS AND THE KIND OF
ISSUES THAT ARE SPECIFIC IN THIS
FROM AN ETHICAL PERSPECTIVE, I
WOULD LIKE NOW TO TURN TO THE
DEBATE ABOUT THE STANDARD OF
CARE IN INTERNATIONAL
COLLABORATIVE RESEARCH, AND
BASICALLY THE OVERALL ARGUMENT
THAT I WOULD LIKE TO MAKE IS
THAT IT LOOKS ON THE FACE OF IT
LIKE AS AT THE DEBATE MAINLY
ABOUT WHAT IS OWED TO INDIVIDUAL
PARTICIPANTS, SO THIS ARISES
MAINLY IN THE CONTEXT OF
RANDOMIZED CONTROL TRIALS WHERE
A NEW INTERVENTION IS BEING
TESTED AGAINST AN EXISTING ONE,
OR AGAINST A PLACEBO, AND THE
QUESTION IS, WHAT SHOULD WE BE
TESTING IT AGAINST, WHAT SHOULD
BE THE STANDARD OF CARE THAT WE
TEST IT AGAINST.
NOW IF THERE ISN'T A STANDARD OF
CARE, WE CAN EASILY USE PLACEBO,
AND THAT IS SORT OF A VERY
ATTRACTIVE DESIGN BECAUSE IT IS
A VERY POWERFUL DESIGN, AND
PROVIDES VERY CLEAN DATA AND IS
ALSO A VERY EFFICIENT DESIGN.
STUDIES ARE NOT THAT BIG.
HOWEVER, IF THERE IS CARE
AVAILABLE AND THAT CARE MIGHT
DIFFER IN DIFFERENT COUNTRIES,
LOW/MIDDLE-INCOME COUNTRIES AND
HIGH INCOME COUNTRIES, WHAT
SHOULD BE THE STANDARD OF CARE,
AND IS IT ACCESSIBLE TO
SOMETIMES GO BELOW WHAT'S THE
BEST GLOBAL STANDARD.
SO THAT DEBATE, THE OVERALL
ARGUMENT I KIND OF WANT TO MAKE
TODAY IS THAT IT LOOKS LIKE ON
THE FACE OF IT IT'S MAINLY ABOUT
WHAT IS OWED TO PARTICIPANTS,
BUT IT HAS MUCH LARGER
IMPLICATIONS FOR WHAT KIND OF
RESEARCH QUESTIONS WE ARE
ACTUALLY ASKING, AND WHETHER
STUDIES ARE FEASIBLE.
AND WE WILL SPEAK ABOUT THIS AS
THE LECTURE KIND OF UNFOLDS.
TO START US OFF, I WANT TO
DESCRIBE THE SET OF TRIALS OF AN
ANTIRETROVIRAL TREATMENT REGIMEN
TO PREVENT TRANSMISSION OF HIV
FROM PREGNANT PEOPLE TO THEIR
OFFSPRING.
THAT KICKED OFF THIS ENTIRE
DEBATE.
SO PREGNANT PEOPLE WHO LIVE WITH
HIV TRANSMIT THE DISEASE TO
ABOUT 15 TO 45% OF THEIR
NEWBORNS IF UNTREATED.
AND IN THE 1990s, A REALLY
SUCCESSFUL REGIMEN WAS DEVELOPED
IN HIGH INCOME COUNTRIES, IT WAS
CALLED O76 AZT, ALSO THE NAME I
WILL BE USING HERE, 076, THAT
LOWERED TRANSMISSION TO LESS
THAN 5% SO HIGHLY EFFECTIVE
INTERVENTION, BUT 076 WAS
COMPLICATED, INVOLVED A LOT OF
STEPS, TREATING THE PREGNANT
PERSON IN THE LAST TRIMESTER,
THEN INFUSING ANTIRETROVIRALS
DURING BIRTH INTRAVENOUSLY AND
THEN TREATING THE CHILD AND ALSO
REFRAINING FROM BREASTFEEDING
BECAUSE HIV CAN BE TRANSMITTED
THROUGH BREAST MILK, AND BOTTLE
FEEDING.
AND THIS IS BOTH VERY COMPLEX
AND REQUIRES A LOT OF
INFRASTRUCTURE TO GET DONE
THAT'S MADE THIS A CHALLENGE TO
IMPLEMENT IN LOW/MIDDLE-INCOME
COUNTRIES.
IT WAS ALSO VERY EXPENSIVE, AT
THE TIME IT WAS ABOUT $800 PER
PREGNANT PERSON AND CHILD, AND
MANY COUNTRIES,
LOW/MIDDLE-INCOME COUNTRIES AT
THE TIME WERE SPENDING LESS THAN
$100 PER YEAR AND PERSON ON
HEALTHCARE, AND MANY COUNTRIES
WITHIN THOSE ACTUALLY LESS.
SO THIS WAS NOT REALLY FEASIBLE
TO IMPLEMENT.
RESEARCHERS THEN WANTED TO
DEVELOP A SHORT COURSE AZT
REGIMEN THAT COULD BE
IMPLEMENTED IN LOW/MIDDLE-INCOME
COUNTRIES.
AND THEY EXPECTED THIS TO BE --
DECIDED THAT A COMPARISON WITH
076 WAS THEREFORE NOT EXPECTED
TO PRODUCE MEANINGFUL RESULTS
AND, THEREFORE, TESTED IT
AGAINST PLACEBO.
NOW THESE TRIALS KICKED OFF A
REALLY SIGNIFICANT CONTROVERSY
AND LOTS OF ETHICAL COMMENTARY
FOLLOWING IT.
THIS IS THE PIECE IN THE NEW
ENGLAND JOURNAL, WHICH IS A
REALLY IMPORTANT JOURNAL IN
MEDICINE, THE TOP JOURNAL IN
MEDICINE, WHERE A PATIENT
ADVOCACY ORGANIZATION BASICALLY
MADE THE ARGUMENT THAT THESE
TRIALS WERE UNETHICAL.
THIS WAS FURTHER AMPLIFIED BY
THE EDITOR OF THE JOURNAL IN AN
EDITORIAL AND LED TO TWO OF THE
KEY SPONSORS OF THESE TRIALS,
THE CDC IN THE U.S. AND THE NIH,
THEIR RESPECTIVE DIRECTORS AT
THE TIME, TO RESPOND.
SO REALLY HIGH PROFILE
CONTROVERSY.
SO LET'S LOOK AT WHAT THE
CRITICS OF THESE TRIALS SAID.
THEY SAID THE SHORT COURSE AZT
TRIALS WERE UNETHICAL BECAUSE
THEY DID NOT PROVIDE THE CONTROL
GROUP WITH THE GLOBAL BEST
STANDARD OF CARE, THAT IS, THE
AZT REGIMEN.
THEY MADE A SMALL QUALIFICATION,
SORT OF A SIDE MARK THAT I JUST
WANT TO NOTE, BUT THEN -- THAT
IT CAN BE ACCEPTABLE TO DEVIATE
FROM THE GLOBAL BEST STANDARD OF
CARE WHEN THE COSTS ARE REALLY
EXCESS SIEVE.
EXCESSIVE.
THE EXAMPLE THEY GIVE IS IF
WE'RE TRYING TO TEST AN
INTERVENTION TO INTERVENE IN
ACUTE MYOCARDIAL INFARCTION, WE
WOULD OFTEN NEED INTENSIVE CARE
FOR THOSE INTERVENTIONS TO WORK,
AND WE COULD NOT REASONABLY
EXPECT TO BUILD INTENSIVE CARE
INFRASTRUCTURE IF THAT DOESN'T
EXIST IN A COUNTRY.
BUT IN GENERAL, THE CLAIM IS,
RESEARCHERS SHOULD PROVIDE THE
CONTROL GROUP THE BEST -- GLOBAL
BEST STANDARD OF CARE WITH SOME
VERY SMALL EXCEPTIONS.
AND THEY GAVE A NUMBER OF
REASONS FOR THESE, AND THESE
ARE, AGAIN, MOSTLY DIRECTED AT
THE PARTICIPANT LEVEL OR THE
INTEREST OF PARTICIPANTS.
SO THEY SAID RESEARCHERS SHOULD
AVOID PREVENTABLE HARM SO THEY
SHOULD GIVE WHAT'S BEST TO
PARTICIPANTS.
THEY SHOULD NOT TREAT
PARTICIPANTS MERELY AS A MEANS
TO GATHERING DATA, SO IF WE DO
NEED TO -- OR IF IT GIVES US
SORT OF THE BEST AND CLEANEST
DATA TO TEST AGAINST PLACEBO AND
WITHHOLD THE GLOBAL BEST
STANDARD OF CARE, WE ARE
TREATING PARTICIPANTS MERELY AS
A MEANS TO GATHERING THOSE DATA,
WE SHOULD NOT BE DOING THIS.
PARTICIPANTS SHOULD ALSO BE
TREATED EQUALLY.
SO THE CLAIM WAS, THESE KIND OF
TRIALS, DOING A PLACEBO
CONTROLLED TRIAL TO TEST THE
SHORT TERM REGIMEN WOULD NOT BE
ACCEPTABLE IN PLACEBO -- THAT
WOULD NOT GO THROUGH ETHICS
REVIEW BECAUSE THE STANDARD OF
CARE IN HIGH INCOME COUNTRIES AT
THE TIME WAS THE 076 REGIMEN AND
WITHHOLDING THAT WITH THE HUGE
BENEFITS YOU JUST SAW WOULD HAVE
EXPOSED PARTICIPANTS TO
EXCESSIVE RISKS SO THEY SAID
LOOK, WE'RE CONDUCTING TRIALS IN
LOW/MIDDLE-INCOME COUNTRIES THAT
WOULD NOT BE ACCEPTABLE IN HIGH
INCOME COUNTRIES, AND SO WE'RE
TREATING PEOPLE UNEQUALLY.
RELATEDLY, THEY SAID WE SHOULD
ADHERE TO UNIVERSAL ETHICAL
STANDARDS ONE OF THE UNIVERSAL
ETHICAL STANDARDS AT THE TIME
WAS THE DECLARATION OF HELSINKI,
WHICH IS AN IMPORTANT DOCUMENT
BY THE WORLD MEDICAL
ORGANIZATION THAT LAYS OUT
PRINCIPLES FOR THE ETHICS OF
CONDUCTING RESEARCH, AND THIS
DECLARATION AT THE TIME SAID IN
ANY MEDICAL STUDY, EVERY PATIENT
INCLUDING THOSE OF THE CONTROL
GROUP IF ANY SHOULD BE ASSURED
OF THE BEST PROVEN DIAGNOSTIC
AND THERAPEUTIC METHODS.
THIS DOES NOT INCLUDE THE USE OF
INERT PL PLACEBO IN STUDIES WHEE
NO PROVEN DIAGNOSTIC OR
THERAPEUTIC METHOD EXISTS.
THIS IS THE CURRENT VERSION, I'M
NOT GOING TO GO INTO DETAIL, YOU
CAN READ THE SLIDES LATER, THEY
NOW HAVE SOME EXCEPTIONS, SOME
SMALL EXCEPTIONS FROM THIS, BUT
REALLY STILL, YOU KNOW, GIVE A
REALLY STRONG DEFAULT TO PROVING
AGAINST THE BEST INTERVENTION.
SO THE THOUGHT HERE WAS, IF I GO
BACK HERE, THE UNIVERSAL ETHICAL
STANDARD IS TO TEST AGAINST THE
BEST GLOBAL INTERVENTION
AVAILABLE, AND THOSE STUDYS WERE
VIOLATING THAT STANDARD.
SO THESE ARE, I THINK,
INTUITIVELY VERY COMPELLING
CLAIMS, AND THEY REQUIRE A
RESPONSE.
SO HOW MIGHT ONE DEFEND THOSE
TRIALS?
WHAT COULD YOU SAY IN THEIR
SUPPORT?
I WANT TO TRY TO GIVE DIFFERENT
POSSIBLE ANSWERS AND TALK
THROUGH THEM AND KIND OF SEE --
TRY TO CONVINCE YOU THAT ONE
PARTICULAR ANSWER, I THINK, IS
THE CORRECT ONE.
SO IS IT PERMISSIBLE TO PROVIDE
LESS THAN THE GLOBAL BEST
STANDARD OF CARE?
AND IF SO, UNDER WHAT CONDITION?
SO ONE WAY OF DEFENDING THE AZT
TRIALS IN RESPONSE TO THOSE
CRITICISMS WOULD BE TO INVOKE
WHAT I LIKE TO CALL THE NO-LOSS
VIEW, AND THAT BASICALLY SAYS
IT'S PERMISSIBLE TO PROVIDE LESS
THAN THE GLOBAL BEST STANDARD OF
CARE IF PARTICIPANTS ARE NOT
DEPRIVED OF TREATMENT THAT THEY
WOULD OTHERWISE RECEIVE.
THE IDEA IS PRETTY SIMPLE.
PEOPLE ARE NOT GETTING ANY
TREATMENT TO PREVENT HIV
TRANSMISSION AT THE MOMENT, AND,
THEREFORE, IT'S ACCEPTABLE NOT
TO GIVE TO THEM IN THE RESEARCH
AS WELL.
SO THIS WOULD IMPLY SORT OF THAT
THE RESEARCHERS COULD PROVIDE
WHAT IS THE LOCAL STANDARD OF
CARE DE FACTO.
I THINK THIS VIEW IS PROBLEMATIC
BECAUSE WHAT IS THE STANDARD --
LOCAL STANDARD OF CARE DE FACTO
MAY NOT BE ACCEPTABLE, SO YOU
CAN THINK OF A -- YOU KNOW,
INEFFICIENT OR DYSFUNCTIONAL
HEALTHCARE SYSTEM THAT DOES NOT
EFFECTIVELY DELIVER
INTERVENTIONS TO PEOPLE THAT
THEY REALLY SHOULD RECEIVE.
SAY, YOU KNOW, VERY BASIC
IMMUNIZATIONS THAT ARE VERY EASY
AND SUPER EFFECTIVE AND EASY TO
IMPLEMENT, EVERYBODY SHOULD HAVE
ACCESS TO THOSE.
SO JUST BECAUSE IN SOME
SITUATIONS PEOPLE DON'T HAVE
ACCESS TO THEM IS NOT A GOOD
REASON NOT TO PROVIDE THEM.
THIS IS WHAT I THINK COMES OUT
REALLY NICELY IN HERE, THE
PATIENT ADVOCATE SAID THAT, YOU
KNOW, THAT'S NOT A GOOD WAY OR
THE ADVOCATES CRITICIZED THE AZT
TRIALS SAID THAT IN A VERY NICE
WAY.
THEY SAID NOTHING IS A
DESCRIPTION OF WHAT HAPPENED,
STANDARD OF CARE IS A NORMATIVE
STANDARD OF EFFECTIVE MEDICAL
TREATMENT, WHETHER OR NOT IT IS
PROVIDED TO A PARTICULAR
COMMUNITY.
AND I THINK THAT'S EXACTLY RIG
RIGHT.
SO THE BETTER VIEW TO RESPOND TO
THAT IS TO DEVELOP SOMETHING
THAT IS PRECISELY SORT OF THE
NORMATIVE VIEW OR NORMATIVE
STANDARD OF CARE THAT THE
ADVOCATES WERE REFERRING TO, AND
THAT WOULD BE SOMETHING LIKE THE
APPROPRIATE LOCAL CARE VIEW.
AND THAT WOULD SAY IT IS
PERMISSIBLE TO PROVIDE LESS THAN
THE GLOBAL BEST STANDARD OF CARE
IF PARTICIPANTS ARE NOT DEPRIVED
OF TREATMENT THAT THEY SHOULD
OTHERWISE RECEIVE.
AND THAT THEN IMPLIES THAT
RESEARCHERS SHOULD PROVIDE WHAT
IS SORT OF THE NORMATIVE LOCAL
STANDARD OF CARE, THE DE JURE
LOCAL STANDARD OF CARE THAT ALEX
LONDON HAS PROPOSED AS A
TERMINOLOGY.
I THINK THAT IS QUITE OBVIOUSLY
THE CORRECT VIEW.
I DO THINK IT'S NOT AS EASY TO
IMPLEMENT AND THAT IS JUST
SOMETHING TO BE AWARE.
SO EARLY ATTEMPTS, I THINK, HAD
SIMILAR PROBLEMS THAN THE DE
FACTO LOCAL STANDARD OF CARE,
THAT IS, THEY BASICALLY TRIED TO
ANCHOR THE NORMATIVE STANDARD OF
CARE AND WHAT IS THE CASE, AND
SO IF YOU LOOK AT THE NUFFIELD
COUNCIL, IT SAYS THE STANDARD OF
CARE IS WHAT THE COUNTRY
ENDEAVORS TO PROVIDE NATIONALLY
BUT YOU CAN THINK OF COUNTRIES
THAT JUST DON'T ENDEAVOR TO
PROVIDE ENOUGH, THEY'RE NOT
AMBITIOUS ENOUGH OR THEY THINK,
YOU KNOW, THEY SHOULD SPEND ON
MILITARY RATHER THAN RESEARCH OR
SOMETHING -- I'M SORRY,
HEALTHCARE OR SOMETHING LIKE
THAT.
SIMILARLY, A RELATED DEFINITION
WHICH IS WHAT THE HIGHEST LEVEL
OF CARE THAT IS ATTAINABLE IN
THE HOST COUNTRY, YOU CAN THINK
AGAIN LIKE, YOU KNOW, IF THE
HEALTHCARE INFRASTRUCTURE
LOCALLY HAS REALLY BEEN
NEGLECTED, AND THAT IS SORT OF
CAN BE SEEN AS AN INJUSTICE,
THEN THIS IS NOT AN ADEQUATE
NORMATIVE STANDARD OF CARE.
THE CURRENT VERSION OF THESE
VERY GUIDELINES HERE FROM UNAIDS
I THINK GETS TO THE IDEA MUCH
BETTER BECAUSE THEY SAY IT'S A
PACKAGE AND THEY SPEAK ABOUT HIV
PREVENTION TRIALS SO THEY TALK
ABOUT PREVENTION METHODS THAT
ARE RECOMMENDED BY THE WHO AND
THEN THEY EXPLAIN IN QUITE A LOT
OF DETAIL WHAT A WHO
RECOMMENDATION MEANS, NAMELY,
THAT IT IS BASED ON A VERY
CAREFUL REVIEW OF THE EVIDENCE
OF EFFECTIVENESS BUT ALSO OF
COST-EFFECTIVENESS OF THE
INTERVENTIONS, OF OTHER
CONSIDERATIONS, YOU KNOW, WHO
WOULD BENEFIT FROM THE
INTERVENTION AND SO ON, THAT ARE
OF ETHICAL NATURE, ALL OF THAT
IS DONE IN A FAIR AND
TRANSPARENT PROCESS WITH ALSO
INPUT FROM THE COMMUNITY, AND
THE WHO IS SORT OF FOCUSED ON
PROVIDING GUIDANCE FOR
LOW/MIDDLE-INCOME COUNTRIES THAT
MIGHT NOT HAVE THE RESOURCES TO
DEVELOP THEIR OWN GUIDANCE, SO
IT ALSO SEEMS APPROPRIATE SORT
OF FROM THAT PERSPECTIVE.
I THINK THAT IS SORT OF THE
RIGHT APPROACH.
I WOULD JUST NUANCE IT A LITTLE
BIT MORE, BECAUSE I DO THINK THE
GLOBAL STANDARD OF CARE MAY NOT
BE SUFFICIENTLY
CONTEXT-SENSITIVE, SO IDEALLY, I
THINK WE WOULD DO SOMETHING
SIMILAR TO WHAT THIS DOCUMENT
PROPOSES, NAMELY THAT
APPROPRIATE LOCAL CARE, THE
LOCAL STANDARD OF CARE SHOULD BE
KIND OF DEFINED IN A FAIR AND
TRANSPARENT PROCESS THAT SETS
PRIORITIES LOCALLY ON THE PATH
TO UNIVERSAL HEALTHCARE
COVERAGE.
SO SETS PRIORITIES AS COUNTRIES
SCALE UP THEIR HEALTHCARE
COVERAGE AND DEVELOP THEIR
HEALTHCARE PACKAGES AND MAKE
VERY EXPLICIT PRIORITIES UNDER
RESOURCE CONSTRAINTS WHAT TO
INCLUDE.
I THINK THAT WOULD BE SORT OF
THE IDEAL AND WHERE SUCH A
PROCESS DOES NOT EXIST, IT
SHOULD SERVE AS SORT OF AN IDEAL
OR HEURISTIC TO DETERMINE WHAT
APPROPRIATE LOCAL CARE MIGHT BE.
SO IF YOU APPLY THAT TO THE AZT
TRIALS, FEW LOW/MIDDLE-INCOME
COUNTRIES AT THE TIME AND ALSO
ACTUALLY FEW HIGH-INCOME
COUNTRIES HAD A FAIR PRIORITY
SETTING PROCESS AND I THINK THE
SAME STILL HOLDS TRUE TODAY,
THOUGH TO A LESSER EXTENT.
BUT YOU CAN SEE THAT THE 076 AZT
REGIMEN, I BRIEFLY MENTIONED THE
COST EARLIER, COSTS ABOUT --
MORE THAN 10 TIMES MORE THAN THE
HEALTHCARE BUDGET PER PERSON AND
YEAR IN MOST LOW/MIDDLE-INCOME
COUNTRIES AT THE TIME, AND IT
SEEMS UNLIKELY TO ME THAT
GIVEN -- A GIVEN
LOW/MIDDLE-INCOME COUNTRY WOULD
INCLUDE THE REGIMEN IN ITS BASIC
HEALTHCARE PACKAGE, AND HENCE IT
SEEMS UNLIKELY THAT IT WOULD BE
SORT OF THE NORMATIVE STANDARD
OF CARE UNDER LOCAL
CIRCUMSTANCES.
SO I THINK FROM THAT
PERSPECTIVE, NOT PROVIDING THE
076 REGIMEN IS ACCEPTABLE.
I ALSO THINK THAT THAT IS NOT
THE WHOLE STORY THAT WE CAN GIVE
TO DEFEND THESE TRIALS, OR THAT
WE SHOULD GIVE TO DEFEND THESE
TRIALS, BECAUSE IT FOCUSES ONLY
ON THE LEVEL OF THE INDIVIDUAL
PARTICIPANTS.
I THINK THERE MUST ALSO BE A
POSITIVE JUSTIFICATION FOR
TESTING AGAINST A LOWER STANDARD
OF CARE, SO IT'S NOT ENOUGH TO
JUST SAY, WE'RE NOT MAKING
PEOPLE WORSE ON THAN THEY SHOULD
HAVE BEEN OUTSIDE THE RESEARCH.
AND THIS IS WHERE I THINK IT'S
IMPORTANT, REALLY CRITICAL,
ACTUALLY, TO SEE THAT THE CHOICE
OF THE STANDARD OF CARE HAS
IMPLICATIONS FOR WHAT RESEARCH
QUESTIONS WE ARE ASKING, SO WHAT
WE ARE ACTUALLY COMPARING, AND
THEN WHAT IT HAS IMPLICATIONS
FOR SORT OF THE FEASIBILITY OF
THE TRIALS.
SO THERE IS A DIFFERENCE BETWEEN
ASKING, YOU KNOW, IS THIS SHORT
COURSE REGIMEN, YOU KNOW, WHEN
YOU COMPARE TO PLACEBO, IS THE
SHORT COURSE REGIMEN BETTER
BASICALLY THAN NOTHING, IS THE
QUESTION THAT YOU'RE ASKING WITH
A PLACEBO CONTROL, VERSUS WHEN
YOU'RE COMPARING TO THE
076 REGIMEN, YOU'RE ASKING IS IT
WORSE THAN, YOU KNOW, WHAT'S
CURRENTLY THE GLOBAL BEST.
OR, YOU KNOW, AND HOW MUCH WORSE
IS IT OR IS IT COMPARABLE TO IT.
SO THERE'S A DIFFERENT RESEARCH
QUESTION THAT YOU ARE ASKING AND
IT GIVES YOU DIFFERENT DATA THAT
MAY OR MAY NOT BE RESPONSIVE
TO -- OR MAY NOT BE THE
INFORMATION THAT PEOPLE NEED
LOCALLY.
IT ALSO HAS IMPLICATIONS, YOU
KNOW, FOR THE SIZE OF THE TRIALS
AND THE KIND OF DATA THAT YOU'RE
GETTING, SO IF YOU'RE TESTING
AGAINST A PLACEBO, I MENTIONED
EARLIER IT'S A VERY POWERFUL
DESIGN THAT OFTEN INVOLVES FEWER
PARTICIPANTS THAN ACTIVE
COMPARATOR TRIALS, WHERE YOU'RE
TESTING AGAINST, YOU KNOW, AN
INTERVENTION THAT ALREADY
EXISTS, THEY'RE MUCH LARGER, AND
SOMETIMES THAT CAN MAKE THE
DIFFERENCE BETWEEN CONDUCTING A
TRIAL OR NOT CONDUCTING A TRIAL
AT ALL, BECAUSE THE TRIALS WHEN
THEY'RE REALLY BIG, YOU KNOW,
THEY'RE LOGISTICALLY CHALLENGING
AND THEY'RE EXPENSIVE.
SO I THINK THIS IS REALLY
IMPORTANT TO SEE, SO I THINK
THAT LEADS US TO SUPPLEMENTING
SORT OF THE APPROPRIATE STANDARD
OF CARE VIEW WITH BROADENING IT
AND GIVING THIS POSITIVE
JUSTIFICATION FOR WHEN IT IS
JUSTIFIED TO USELESS THAN THE
GLOBAL BEST STANDARD, AND THAT
IS SOMETHING THAT ONE MIGHT CALL
THE RESPONSIVENESS VIEW, WHICH
SAYS THAT IT'S PERMISSIBLE TO
PROVIDE LESS THAN THE GLOBAL
BEST STANDARD OF CARE IF THE
RESEARCH IS RESPONSIVE TO LOCAL
HEALTH NEEDS AND PRIORITIES, IF
IT'S SCIENTIFICALLY NECESSARY TO
TEST AGAINST A LOWER STANDARD OF
CARE, AND THEN THE LOCAL
STANDARD OF CARE IS NOT UNDER
THE KIND OF APPROPRIATE LOCAL
STANDARD OF CARE THAT WE JUST
TALKED ABOUT, THAT IS THE
CONDITION THREE HERE.
AND THIS IS BASICALLY THE
DEFENSE THAT THE DIRECTORS OF
THE NIH AND THE CDC GAVE OF
THOSE TRIALS.
THEY SAID THE MOST COMPELLING
REASON TO USE A PLACEBO
CONTROLLED STUDY IS THAT IT
PROVIDES DEFINITIVE ANSWERS TO
QUESTIONS ABOUT THE SAFETY AND
VALUE OF AN INTERVENTION IN THE
SETTING IN WHICH THE STUDY IS
PERFORMED, AND THESE ANSWERS ARE
THE POINT OF THE RESEARCH.
WITHOUT CLEAR AND FIRM ANSWERS
TO WHETHER AND IF SO HOW WELL AN
INTERVENTION WORKS, IT IS
IMPOSSIBLE FOR A COUNTRY TO MAKE
A SOUND JUDGMENT ABOUT THE
APPROPRIATENESS AND FINANCIAL
FEASIBILITY OF PROVIDING THE
INTERVENTION.
SO LET ME JUST TALK YOU THROUGH
HOW THIS VIEW MIGHT APPLY TO THE
AZT TRIALS.
SO THOSE TRIALS WERE RESPONSIVE
TO LOCAL HEALTH NEEDS BECAUSE
OBVIOUSLY HIV TRANSMISSION WAS A
BIG PROBLEM IN MANY OF THOSE
COUNTRIES.
THEY WERE ALSO RESPONSIVE
BECAUSE THEY AIMED TO DEVELOP A
SHORT COURSE REGIMEN THAT WOULD
BE FEASIBLE TO IMPLEMENT IN
THOSE COUNTRIES, SO THEY WERE
TARGETED AT THOSE -- AT THAT
SETTING.
AND THEY ANSWERED A KEY QUESTION
FOR LOCAL POLICY MAKERS, WHICH
WAS -, IS A SHORT COURSE BETTER
THAN NOTHING?
IF SO, BY HOW MUCH, AND,
THEREFORE, IS IT WORTH INVESTING
OUR SCARCE RESOURCES?
REMEMBER, AGAIN, THAT HEALTHCARE
BUDGETS AT THE TIME WERE $100 OR
LESS A YEAR AND PERSON IN MANY
OR MOST LOW AND MIDDLE INCOME
COUNTRIES AT THE TIME.
SO THE RELEVANT QUESTION THERE
IS NOT HOW MUCH WORSE IS IT.
THEY ALREADY KNEW THAT THE SHORT
COURSE REGIMEN IS GOING TO BE
LESS EFFECTIVE, AND SO IT'S NOT
LIKE, YOU KNOW, IF WE INVEST IN
THIS, HOW MUCH WORSE IS IT.
THE QUESTION THAT LOCAL POLICY
MAKERS REALLY HAD IS -- ARE
THESE THAT I JUST READ OUT.
THE PLACEBO CONTROL IN THIS CASE
ALSO MEANT I WOULD ARGUE THE
SECOND CONDITION, BECAUSE IT WAS
SCIENTIFICALLY NECESSARY GIVEN
THAT THERE WAS VARIABLE
PERINATAL HIV TRANSMISSION AND
NOT ENOUGH DATA ABOUT HOW MUCH
TRANSMISSION WAS HAPPENING
WITHOUT INTERVENTION THAT WE
COULD HAVE MADE SOLID INFERE
INFERENCES.
AND RELATEDLY IT LED TO THE
TRIALS BEING MUCH MORE FEASIBLE
BECAUSE PLACEBO CONTROLLED TRIAL
IS THIS VERY POWERFUL AND
EFFICIENT DESIGN.
SO I THINK THE RESPONSIVENESS
VIEW BASICALLY IS SORT OF
ROUGHLY LIKE THE RIGHT VIEW.
I HAVE A COUPLE MODIFICATIONS
THAT I TALK ABOUT LATER TO IT.
BUT THIS KIND OF RESPONSE THEN
KICKED OFF THESE LARGER
QUESTIONS ABOUT WHAT -- BY THE
NIH AND CDC DIRECTORS, WHAT KIND
OF RESEARCH ACTUALLY WE SHOULD
BE CONDUCTING AND WHETHER -- IN
ORDER TO IMPROVE HEALTH IN
LOW/MIDDLE-INCOME COUNTRIES AND
REDUCE GLOBAL HEALTH INEQUITY
AND INDEED IF WE SHOULD BE
CONDUCTING RESEARCH AT ALL.
SO ONE CRITIQUE OF THE
RESPONSIVENESS VIEW IS THAT THE
RESEARCH IS NOT RESPONSIVE TO
LOCAL HEALTH NEEDS WHEN IT
DEVELOPS INTERVENTIONS THAT ARE
EXPECTED TO BE INFERIOR TO THE
GLOBAL BEST STANDARD OF CARE.
INSTEAD WHAT RESEARCHERS SHOULD
BE DOING IS THEY SHOULD DEVELOP
INTERVENTIONS THAT ARE EXPECTED
TO BE NON-INFERIOR TO OUR
EQUIVALENT WITH THE GLOBAL BEST
STANDARD OF CARE.
THERE IS ALSO HERE A QUOTE IN
THE DEBATE FROM ALL THE PAPERS
THAT I SHOWED INITIALLY THE
CONTROVERSY AROUND THE AZT
TRIALS WHERE THEY SAID THE
RESEARCHERS CONDUCTING THE PLA
PLACEBO CONTROLLED TRIALS
REPRESENT THE ONLY RESEARCH
DESIGN SO THE ANSWER TO THE
QUESTION IS A SHORTER REGIMEN
BETTER THAN NOTHING?
WE TAKE THE OPTIMISTIC VIEW THAT
THE FINDINGS OF ACTG076 AND
OTHER CLINICAL INFORMATION
RESEARCHES ARE QIELT CAPABLE OF
DESIGNING A SHORTER
ANTIRETROVIRAL REGIMEN THAT IS
APPROXIMATELY AS EFFECTIVE AS
THE 076 REGIMEN.
SO I THINK THAT CRITIQUE IS, OF
COURSE, CORRECT TO THE EXTENT
THAT WE CAN, WE SHOULD BE
CONDUCTING RESEARCH THAT AIMS TO
BE OR DEVELOPING INTERVENTIONS
INCLUDING FOR LOW/MIDDLE-INCOME
COUNTRIES THAT ARE JUST AS GOOD
OR BETTER THAN OTHER
INTERVENTIONS, THAT'S THE
ESSENCE OF PROGRESS.
BUT I ALSO THINK THAT IF YOU'RE
TRYING TO GET SOMETHING THAT
ISES EASIER, SIMPLER TO IMPLEMET
IN SETTINGS THAT HAVE FEWER
RESOURCES IN LOW/MIDDLE-INCOME
COUNTRIES AND THAT IS ALSO LESS
EXPENSIVE, THAT CAN BE A TALL
ORDER, SO IT CAN BE -- YOU KNOW,
YOU SHOULD STRIVE FOR IT, BUT IT
MAY NOT ALWAYS BE POSSIBLE.
I ALSO THINK THAT IT RAISES SORT
OF -- YOU KNOW, IF THAT'S WHAT
YOUR GOAL IS, YOU'RE TRYING TO
FIND INTERVENTIONS AND TRYING TO
DEMONSTRATE THAT THEY'RE JUST AS
GOOD AS WHAT WE ALREADY HAVE.
THEY'RE JUST SIMPLER AND
CHEAPER.
THAT RAISES THESE QUESTIONS
ABOUT THE FEASIBILITY OF THE
TRIAL, BECAUSE THOSE ACTIVE
COMPARATOR TRIALS WERE TESTING A
NEW INTERVENTION AGAINST THE
EXISTING ONES REQUIRE LARGE
SAMPLE SIZES.
SO THAT CAN SOMETIMES MAKE IT
INFEASIBLE, THE COSTS ASSOCIATED
WITH THAT AND THE LOGISTICAL
EFFORT MAKE IT INFEASIBLE TO
CONDUCT THOSE TRIALS.
SO I THINK WE SHOULD -- THIS IS
DEFINITELY SOMETHING WE SHOULD
TRY DO, BUT I THINK ALSO THAT
DEVELOPING SECOND-BEST
INTERVENTIONS IS KIND OF A TERM
ONE MIGHT USE, THINGS THAT ARE
STILL GOOD BUT NOT AS GOOD AS
WHAT WE ALREADY HAVE, CAN BE KEY
TO IMPROVING HEALTH IN
LOW/MIDDLE-INCOME COUNTRIES, AND
THEREBY REDUCING GLOBAL HEALTH
INEQUITIES.
ANOTHER CRITIQUE OF THE VIEW
THAT'S SORT OF THIS BROADER
NATURE ABOUT WHAT RESEARCH
SHOULD WE CONDUCT OR SHOULD WE
ACTUALLY BE CONDUCTING RESEARCH
AT ALL IS THIS ONE.
IT SAYS THAT DEVELOPING SIMPLER,
CHEAPER AND INFERIOR
INTERVENTIONS IS NOT THE RIGHT
APPROACH TO IMPROVING HEALTH IN
LOW/MIDDLE-INCOME COUNTRIES AND
REDUCING GLOBAL HEALTH
INEQUITIES.
INSTEAD WE SHOULD WORK ON
LOWERING DRUG PRICES, INVEST IN
HEALTHCARE INFRASTRUCTURE OR
HEALTH INFRASTRUCTURE IN
LOW/MIDDLE-INCOME COUNTRIES,
DEVELOP MORE EQUITABLE WAYS OF
INCENTIVIZING INNOVATION SO THAT
MORE INNOVATION HAPPENS THAT'S
TARGETED AT LOW/MIDDLE-INCOME
COUNTRIES AND SO ON.
AGAIN, IN THE INTEREST OF TIME
I WILL SKIP THIS QUOTE BUT YOU
CAN SEE IT HERE AND REVIEW IT
WHEN YOU LOOK AT THE SLIDES THAT
ARE AVAILABLE TO YOU.
AGAIN I THINK THIS IS A GREAT
SORT OF POINT TO MAKE.
SOMETIMES RESEARCH IS NOT
PROVIDING ANSWERS TO QUESTIONS
AND WE SHOULD DEFINITELY WORK TO
IMPROVE HEALTH IN
LOW/MIDDLE-INCOME COUNTRIES AND
REDUCE GLOBAL HEALTH INEQUITIES
BEYOND CONDUCTING RESEARCH.
BUT I THINK IT SHOULD NOT
EXCLUDE OR THE TWO ARE NOT SORT
OF MUTUALLY EXCLUSIVE, BUT THE
TWO CAN GO IN TANDEM, AND AGAIN,
I THINK DEVELOPING THOSE
SECOND-BEST INTERVENTIONS THAT
ARE FEASIBLE TO IMPLEMENT IN THE
SHORTER TERM CAN BE -- CAN LEAD
TO REALLY IMPORTANT HEALTH
BENEFITS AND REDUCTIONS IN
GLOBAL HEALTH INEQUITIES.
SO IF YOU DON'T CONDUCT THE
RESEARCH AND YOU WAIT UNTIL DRUG
PRICES HAVE COME DOWN AND, YOU
KNOW, HEALTHCARE INFRASTRUCTURE
IS OTHERWISE SCALED UP AND SO
ON, THAT MEANS TIME WILL PASS,
THAT MEANS FEWER PEOPLE -- THE
MORE TIME IT TAKES FOR
INTERVENTIONS TO BE IMPLEMENTED
IN PRACTICE, THE MORE PEOPLE
WITH SUFFER OR POTENTIALLY DIE
IN THE MEANTIME.
SO THESE SECOND-BEST
INTERVENTIONS CAN REALLY HELP TO
DO SOMETHING IN THE HERE AND NOW
WHILE WE'RE WORKING TO IMPROVE
THINGS OTHERWISE.
IN CONCLUSION, I THINK THE
STANDARD OF CARE DEBATE REVEALS
DIFFERENT POSITIONS ON WHAT IS
OWED TO PARTICIPANTS IN
INTERNATIONAL COLLABORATIVE
RESEARCH IN LOW/MIDDLE-INCOME
COUNTRIES.
THAT WAS REALLY THE STARTING
POINT OF THAT DEBATE, BUT WHEN
YOU LOOK MORE CLOSELY TO HOW IT
UNFOLDED, IT ACTUALLY ALSO
REVEALS DIFFERENT POSITIONS ON
WHAT RESEARCH SHOULD BE
CONDUCTED AND HOW IT SHOULD BE
CONDUCTED AND WHETHER WE SHOULD
CONDUCT RESEARCH AT ALL IN ORDER
TO IMPROVE HEALTH IN
LOW/MIDDLE-INCOME COUNTRIES AND
REDUCE GLOBAL HEALTH INEQUITIES.
THE RESPONSIVENESS VIEW WITH TWO
SMALL MODIFICATIONS THAT I'LL
PROJECT IN JUST A MINUTE IS IN
MY VIEW THE MOST COMPELLING IN
THESE POSITIONS AND I'LL TRY TO
EXPLAIN WHY THIS IS THE CASE.
I'M JUST PROJECTING IT HERE
AGAIN TO REMIND YOU OF WHAT THIS
VIEW IS, AND I JUST WANT TO SAY
THAT I THINK THERE ARE TWO
MODIFICATIONS, ONE IS THAT I
THINK COMMUNITY ENGAGEMENT ABOUT
THAT KIND OF -- THOSE KINDS OF
DECISIONS ABOUT WHETHER THE
RESEARCH IS RESPONSIVE TO LOCAL
HEALTH NEEDS AND PRIORITIES, IN
PARTICULAR, AND WHAT THE SORT OF
APPROPRIATE LOCAL STANDARD OF
CARE IS, IS REALLY IMPORTANT TO
GET AS MUCH INPUT AS POSSIBLE
FROM THE LOCAL COMMUNITY, SO I
THINK COMMUNITY ENGAGEMENT WOULD
BE A CONDITION I WOULD ADD AND
DORCAS KAMUYA IS GOING TO SPEAK
MORE ABOUT THIS.
I ALSO THINK THERE ARE SOME
CIRCUMSTANCES THAT I'D BE HAPPY
TO TALK ABOUT DURING THE Q & A
WHERE IT MIGHT BE ACCEPTABLE TO
WITHHOLD THE APPROPRIATE LOCAL
STANDARD OF CARE.
SO I THINK IT SHOULD BE A STRONG
DEFAULT TO TEST AGAINST WHAT'S
THE DE JURE STANDARD OF CARE BUT
I THINK THERE ARE SITUATIONS
WHERE IT'S ACCEPTABLE TO
WITHHOLD IT.
SO WITH THAT, I THANK YOU SO
MUCH.
[APPLAUSE]
>> THANK YOU, ANNETTE, AND WHY
DON'T YOU STAY THERE BECAUSE
YOU'LL BE MIC'D THERE.
SO WE HAVE ABOUT 10 MINUTES FOR
QUESTIONS.
I'M HOPING MARCOS IS GOING TO BE
WALKING OVER TO ASK THE
QUESTIONS ABOUT THIS TOPIC.
OH, GREAT.
SO CHLOE HAS A QUESTION.
LET'S START WITH CHLOE, AND THEN
I HAVE ONE FROM OUR VIDEO
VIEWERS.
>> HI, ANNETTE.
THANKS FOR THAT.
THAT WAS SUPER INTERESTING.
I WAS JUST WONDERING IF THERE'S
MUCH DISCUSSION ABOUT KIND OF
FURTHER COMPROMISES WE CAN HAVE
IN THESE SITUATIONS.
LIKE FOR EXAMPLE, DO WE REALLY
ALWAYS NEED TO DO A RANDOMIZED
CONTROL TRIAL?
ARE THERE ANY OTHER TRIAL
DESIGNS LIKE OR BIOSTATISTICAL
ANALYSES THAT COULD KIND OF
MITIGATE THESE ISSUES?
I KNOW SOMETIMES WE DO SOMETHING
LIKE STEP WISE TRIALS WHERE
EVERYONE GETS THE INTERVENTION
EVENTUALLY.
OBVIOUSLY THAT CAN'T HAPPEN WITH
A PREGNANCY BECAUSE THERE'S ONLY
ONE EVENT.
THEN MY OTHER QUESTION IS, DID
ANYONE EVER CONSIDER, I GUESS,
TREATING THE CHILDREN WHO
DEVELOPED HIV INVOLVED IN THE
TRIAL, AND SO LIKE WOULD THAT
HAVE MITIGATED SOME ISSUES?
I KNOW IT WOULD HAVE BEEN
EXPENSIVE TO TREAT THE CHILDREN
EFFECTIVE BUT IN THE GRAND
SCHEME OF THINGS, DO YOU THINK
THAT WOULD HAVE MITIGATED SOME
OF THE PROBLEMS?
>> GREAT QUESTIONS.
THANKS SO MUCH.
SO LET'S TAKE EACH IN TURN.
THERE DEFINITELY IS A LOT OF
DISCUSSION AROUND WHAT I MIGHT
SUMMARIZE AS ALTERNATIVE TRIAL
DESIGNS, ALTERNATIVES TO THE
ACT, WHICH SOMETIMES I THINK IS,
YOU KNOW, EMPHASIZED AS TO THE
GOLD STANDARD, THIS IS WHAT WE
ALWAYS SHOULD BE DOING.
I THINK WE SHOULD BE MUCH MORE
SENSITIVE TO WHAT IS THE GIVEN
RESEARCH QUESTION, WHAT ARE THE
METHODS APPROPRIATE FOR
ANSWERING THIS IN THE CONTEXT IN
WHICH THE TRIAL IS BEING
CONDUCTED.
SO I THINK BROADENING THE ARRAY
OF METHODS IS REALLY IMPORTANT.
AND YOU MENTIONED ONE DESIGN,
THE STEP WEDGE DESIGN, WHICH IS
ONE OF THESE THAT HAS GOTTEN A
LOT OF AIR TIME.
THERE ARE OTHERS TOO THAT -- YOU
KNOW, IN THE RING VACCINATION
DESIGN, FOR EXAMPLE, DURING THE
EBOLA EPIDEMIC.
I THINK IT IS -- OR IN GENERAL
CLUSTER RANDOMIZED CONTROL
DESIGNS, WHERE NOT INDIVIDUALS
BUT CLASSES OF PEOPLE ARE BEING
RANDOMIZED.
I THINK IT IS IMPORTANT TO SEE
WHAT THE METHODOLOGICAL
SHORTCOMINGS ARE OF THOSE, AND
SEE WHETHER, FOR THE GIVEN
RESEARCH QUESTION, IT IS
APPROPRIATE TO USE THAT DESIGN
IN VIEW OF SOME OF THESE
SHORTCOMINGS.
AND, OF COURSE, I WILL SAY, YOU
KNOW, RCTs ALSO HAVE
SHORTCOMINGS, DEPENDING ON HOW
YOU LOOK AT IT.
SO I THINK BASICALLY GOING
AGAINST THIS IDEA THAT RCTs
ARE ALWAYS THE GOLD STANDARD IS
REALLY GOOD BUT IT NEEDS A LOT
OF NUANCE IN TERMS OF COMPARING
THE ALTERNATIVES.
WITH RESPECT TO YOUR SECOND
QUESTION, THE FACTUAL PART, I
DON'T KNOW, SO I DON'T KNOW IF
PEOPLE CONSIDERED TREATING THE
INFANTS, YOU KNOW, THAT DID GET
HIV-INFECTED.
DO YOU, HOLLY, DURING THE AZT
TRIAL?
>> I DON'T.
>> SO THAT IS SOMETHING I'M SURE
CAN BE FOUND OUT.
I DON'T KNOW IT FOR NOW.
I DO THINK THAT COULD HAVE
ALLEVIATED SOME OF THE CONCERNS,
BUT WOULD HAVE ADDRESSED
OTHER -- OR RAISED OTHER
CONCERNS, WHICH IS AT THE TIME
THAT WOULD HAVE BEEN EXTREMELY
INVOLVED, NOT JUST EXPENSIVE
BECAUSE THE PRICES FOR HIV,
ANTIRETROVIRAL TREATMENT, WERE
PRETTY HIGH AT THE TIME AND YOU
WOULD BE COMMITTING TO LIFELONG
TREATMENT, BUT THE
INFRASTRUCTURE WASN'T THERE,
BECAUSE THE TREATMENT IS NOT --
YOU CAN JUST NOT SEND, YOU KNOW,
A BOX OF PILLS, YOU KNOW, ONCE A
MONTH.
PEOPLE, LIKE, NEED THE CARE TO
GO ALONG WITH IT, TO MAKE SURE
THAT YOU'RE MANAGING POSSIBLE
SIDE EFFECTS AND SO ON, AND I
THINK THAT COULD HAVE BEEN
PRETTY HARD TO PULL OFF IN A
RESPONSIBLE WAY AND REALLY
HIGHLIGHTS THE QUESTION THAT I
ONLY TOUCHED ON AND WILL NOT SAY
A WHOLE LOT MORE ABOUT, YOU
KNOW, WHAT IS SORT OF THE CORE
OBLIGATIONS OF THE RESEARCHERS,
AND TO WHAT EXTENT IS ADDRESSING
SORT OF OTHER NEEDS IN THE LONG
TERM, AND/OR OTHER NEEDS THEY
FIND AS PART OF THE RESEARCH,
ESPECIALLY WHEN THOSE ARE LONG
TERM NEEDS.
JOE WILL ACTUALLY SPEAK ABOUT
POST-TRIAL STUDY AND
OBLIGATIONS.
PROBABLY IT WOULD HAVE MITIGATED
SOME OF THE CONCERNS BUT
PROBABLY WOULD RAISE OTHERS AND
WOULD NOT HAVE BEEN FEASIBLE.
>> I'LL JUST ADD, AT THE TIME,
ONE ADDITIONAL CRITIQUE RELATED
TO THIS WAS, WELL, WHAT ABOUT
THE PREGNANT PEOPLE WHO THEN
HAVE CHILDREN, ARE YOU GOING TO
GIVE THEM AZT IN THE LONG RUN?
AND SO I GUESS TO SAY THERE ARE
LOTS OF QUESTIONS ABOUT THE
TRIAL ITSELF, AND THEN WHAT THE
EXPECTED PLAN, HOW YOU PLAN FOR
THAT, WHO'S GOING TO HAVE
ACCESS, ARE ALL ALSO REALLY
IMPORTANT QUESTIONS BEYOND JUST,
QUOTE-UNQUOTE, ALL OF THE
CHALLENGES THAT ANNETTE
DESCRIBED.
CAROLINE.
>> THANK YOU FOR THIS
PRESENTATION.
IT WAS REALLY, REALLY
INTERESTING.
I THINK WHAT I'VE BEEN THINKING
ABOUT IS THAT THIS QUESTION
WOULD ALWAYS ARISE WHEN YOU'RE
THINKING ABOUT A TRADEOFF
BETWEEN LIKE AN UNKNOWN DECREASE
IN EFFICACY AND AN UNKNOW
INCREASE IN DELIVERABILITY IN A
LOW/MIDDLE-INCOME COUNTRY.
I COULD SEE, FOR EXAMPLE, LIKE
IN THIS CASE, IT IS
SIGNIFICANTLY MORE EFFICACIOUS
THAN, LIKE, THE STANDARD OF CARE
IN THAT COUNTRY, BUT IT'S STILL
NOT SIGNIFICANTLY MORE
DELIVERABLE THAN THE ORIGINAL
MEDICATION, AND I'M WONDERING
LIE ISN'T AN EQUALLY IMPORTANT
QUESTION TO INVESTIGATE WHETHER
OR NOT THIS MEDICATION IS, LIKE,
SIGNIFICANTLY MORE DELIVERABLE
AND, THEREFORE, WE SHOULD MAKE
THAT COMPARISON, AND HOW
INVESTIGATORS GO ABOUT, LIKE,
PROVING OR INVESTIGATING THAT
THIS WILL ACTUALLY BE MORE
DELIVERABLE IN THE CONTEXT.
>> GREAT.
TOTALLY CORRECT, BECAUSE THERE
ARE TWO THINGS THAT WE WANT TO
DO.
WE WANT TO BE STILL EFFICACIOUS,
AND WE WANT TO BE MORE
DELIVERABLE.
TYPICALLY, THE SORT OF
RANDOMIZED CONTROL TRIALS OR THE
TRIALS THAT DEMONSTRATE THE
SAFETY AND EFFICACY, THEY ARE
NOT ABLE -- THEY ARE ABLE TO
HAVE, LIKE, YOU KNOW, ADD-ON
STUDIES THAT LOOK AT
DELIVERABILITY WITHIN THE TRIAL
SETTING, BUT THAT IS A VERY
UNIQUE SETTING, YOU KNOW,
BECAUSE IT IS STILL A CONTROLLED
TRIAL.
SO THEY ARE NOT ABLE TO ANSWER
THIS QUESTION ABOUT
DELIVERABILITY.
IT IS A REALLY IMPORTANT
QUESTION, AND ONE THAT I THINK
SHOULD IDEALLY, AND -- IT'S NOT
ALWAYS POSSIBLE BECAUSE THE KIND
OF FORMATIVE RESEARCH TO TO THAT
IS NOT ALWAYS SPONSORED BUT IT
SHOULD IDEALLY HAPPEN BEFOREHAND
AND IT INVOLVES -- THOSE ARE
SOCIAL SCIENTIFIC METHODS,
PERHAPS SOCIOECONOMIC METHODS,
YOU KNOW, THEY ARE ALSO, YOU
KNOW, NOT REALLY METHODS BUT,
LIKE, TALKING TO PEOPLE AND
GETTING POLITICAL COMMITMENT,
YOU KNOW, ON GROUND AND GETTING
A LOT OF SORT OF, YOU KNOW,
CONTEXTUAL INFORMATION ABOUT
WHAT IS AND ISN'T DELIVERABLE IN
THE CIRCUMSTANCES, WHAT PEOPLE
ARE WILLING TO COMMIT TO IF THE
DATA ARE POSITIVE.
IT'S A LOT OF WORK, AND A LOT OF
WORK THAT INVESTIGATORS DO WHO
ARE SERIOUS ABOUT DOING RESEARCH
AND A LOT OF THEM ARE ABOUT
DOING RESEARCH IN
LOW/MIDDLE-INCOME COUNTRIES, BUT
IT'S OFTEN NOT FULLY FUNDED AND,
THEREFORE, PERHAPS DOESN'T
ALWAYS HAPPEN WITH THE RIGOR
THAT IT SHOULD HAPPEN WITH.
THE TRIAL ITSELF, IT'S VERY
WELCOME IF YOU HAVE SORT OF AN
ADD-ON COMPONENT WHERE YOU'RE
ALSO LOOKING AT DELIVERABILITY
WITHIN THE TRIAL SETTING BUT
GIVEN THAT THE TRIAL IS SUCH A
UNIQUE SETTING BECAUSE IT'S
REALLY DESIGNED TO TEST SAFETY
AND EFFICACY, I THINK YOU WILL
ONLY GET LIMITED ANSWERS AND YOU
COULD NEED SUPPLEMENT.
DEFINITELY JUST SAYING OH, WE
THINK THIS WILL BE MORE
DELIVERABLE IS NOT ENOUGH.
YOU NEED A LOT OF EVIDENCE.
>> THANK YOU, ANNETTE.
[APPLAUSE]
>> THANK YOU.
WE DIDN'T GET TO THE PERSON
ONLINE BUT I'M HAPPY --
>> IT'S OKAY, I WILL REACH OUT
TO YOU AS NEEDED.
>> GREAT.
THANK YOU SO MUCH.
>> SO NOW WE ARE GOING TO BE
TRANSITIONS TO JOE MILLUM.
I'M GOING TO INTRODUCE JOE.
JOE IS A SPECIAL FRIEND OF THE
DEPARTMENT.
HE WORKED HERE AT THE CLINICAL
CENTER FOR ABOUT 15 YEARS AND IS
NOW A SENIOR LECTURER AT THE
DEPARTMENT OF PHILOSOPHY AT
ST. ANDREWS UNIVERSITY IN
SCOTLAND.
SO WE'RE WELCOMING HIM.
HE HAS A LONG HISTORY OF
THINKING ABOUT ISSUES RELATED TO
ETHICS OF NATIONAL RESEARCH,
INFORMED CONSENT AND PRIORITY
SETTING, AND IS THE PERFECT
PERSON TO TALK TO US NOW ABOUT
POST TRIAL ACCESS.
SO JOE, ARE YOU CONNECTED OUT
THERE?
>> I'M HERE.
>> GREAT.
THERE YOU ARE.
HELLO, JOE!
SO I'M GOING TO HAND IT OVER TO
YOU.
>> THANK YOU, HOLLY.
THANK YOU SO MUCH FOR HAVING ME.
AND I'M HOPING EVERYONE CAN SEE
MY SCREEN.
>> YES, ALL GOOD.
>> WELL, THANK YOU AGAIN FOR
INVITING ME TO GIVE THIS TALK.
THANKS, ANNETTE, FOR YOUR TALK
AND I'M GOING TO TRY TO FOLLOW
UP ON A COUPLE OF THE QUESTIONS
THAT GOT RAISED BUT NOT
COMPLETELY COVERED IN THE
PRESENTATION THAT ANNETTE JUST
GAVE.
SO ANNETTE DISCUSSED THE ISSUE
OF THE STANDARD OF CARE THAT
SHOULD BE USED IN RESEARCH
STUDIES IN RESOURCE -- SETTINGS.
ONE FTD OTHER KEY ISSUES THAT
SHE INTRODUCED CONCERNED THE
TYPES OF TRIALS THAT ONE COULD
DO IN RESOURCE-POOR SETTINGS,
AND THE ASSOCIATED ISSUE, WHICH
ALSO CAME UP IN THE QUESTIONS,
OF POST TRIAL ACCESS TO
TREATMENTS THAT ARE USED OR
TESTED IN THOSE TRIALS.
AND THAT'S WHAT I'M GOING TO
FOCUS ON TODAY.
SO I'LL START BY BRIEFLY
OUTLINING TWO CASES.
THESE ARE BASED ON REAL STUDIES
BUT I'VE SIMPLIFIED THE DETAILS
SOMEWHAT.
CONCERNS ACCESS TO
ANTIRETROVIRAL -- FOR PATIENTS
WITH HIV/AIDS.
MILLIONS OF PEOPLE AROUND THE
WORLD INCLUDING IN SUB-SAHARAN
AFRICA, SOUTH AMERICA AND
SOUTHEAST ASIA NOW DO HAVE
ACCESS TO ANTIRETROVIRAL
THERAPY.
THE LIFESPAN OF PEOPLE WHO ARE
SUCCESSFULLY MAINTAINED ON ART
IS NOW CLOSE TO THAT OF PEOPLE
WHO DO NOT HAVE HIV.
BUT THOUSANDS OF PATIENTS END UP
HAVING TO MOVE TO DIFFERENT
TYPES OF ANTIRETROVIRAL AS THEIR
STRAIN OF HIV DEVELOPS
RESISTANCE TO THE ART.
THIS STUDY WAS CARRIED OUT WITH
PATIENTS WHO WERE ALREADY ON
SECOND LINE ANTIRETROVIRALS, AND
WHOSE SECOND LINE REGIMENS WERE
NOW FAILING DUE TO RESISTANT
STRAINS OF HIV.
AND THE STUDY SOUGHT TO TEST A
STRATEGY FOR OPTIMIZING
ALTERNATIVE TREATMENT
COMBINATIONS [INAUDIBLE].
IT WAS AN OPEN LABEL PHASE
4 PROSPECTIVE INTERVENTIONAL
STUDY ENROLLING 500 ADULTS WITH
HIV WHOSE TREATMENT WHERE THE
SECOND LINE -- A TYPE OF
ANTIRETROVIRAL WAS FAILING.
THE GOAL OF THE STUDY WAS TO
TEST A NOVEL METHOD FOR
ASSESSING A PATIENT'S RESISTANCE
TO HIS OR HER CURRENT ART
REGIMEN, AND THEN ASSIGNING THEM
TO ANOTHER TREATMENT REGIMEN
WITH A DIFFERENT COMBINATION OF
ANTIRETROVIRAL DRUGS.
THE STUDY HAD SITES IN BRAZIL,
KENYA, MALAWI, PERU, SOUTH
AFRICA, THAILAND AND UGANDA.
NOW ALL OF THE DRUGS THAT WE
USED IN THE TRIAL WERE LICENSED
IN THE UNITED STATES.
THEY WERE NOT ALL LICENSED IN
THE COUNTRIES WHERE THE TRIAL
WAS TAKING PLACE.
THIS MEANT THAT PARTICIPANT
MIGHT HAVE BEEN PLACED ON A
LIFE-SAVING TREATMENT REGIMEN
BUT THEY WOULDN'T BE ABLE TO
OBTAIN THE SAME COMBINATION OF
DRUGS WHEN THEY LEFT THE TRIAL.
AND TO THE RESEARCHERS WHO WERE
DESIGNING THE STUDY, THIS SEEMED
UNETHICAL.
SECOND CASE CONCERNS A RESEARCH
STUDY OF HUNTINGTON'S DISEASE.
HUND.IF SOMEONE HAS HUNTINGTONSN
NORMALLY HER CHILDREN HAVE A 50%
CHANCE OF INHERITING THE GENE
AND SO DEVELOPING THE DISEASE AS
WELL.
SYMPTOMS OF HUNTINGTON'S DISEASE
USUALLY START BETWEEN THE AGES
OF 30 AND 50.
IT CAUSES UNCOORDINATED JERKY
BODY MOVEMENTS, A DECLINE OF
MENTAL CAPACITY INTO DEMENTIA.
MOST HUNTINGTON'S PATIENTS DIE
WITHIN 20 YEARS OF THE ONSET OF
THEIR SYMPTOMS.
THERE'S A RURAL COMMUNITY IN
NORTHWEST VENEZUELA THAT HAS THE
HIGHEST CONCENTRATION OF
HUNTINGTON'S CARRIERS IN THE
WORLD.
THIS MADE IT AN IDEAL COMMUNITY
FOR CARRYING OUT RESEARCH INTO
THE DISEASE.
IN 1993, U.S. RESEARCHERS VIEWED
SAMPLES OF BLOOD AND SEMEN TO
IDENTIFY THE GENE THAT WAS
RESPONSIBLE FOR CAUSING
HUNTINGTON'S.
AS A RESULT OF THAT RESEARCH, A
GENETIC TEST WAS DEVELOPED THAT
COULD DETERMINE WHETHER OR NOT
SOMEONE WAS A CARRIER OF THE
DISEASE.
THAT TEST IS NOW AVAILABLE IN
MANY HEALTHCARE SYSTEMS AROUND
THE WORLD.
IT'S NOT AVAILABLE TO THE PEOPLE
THERE.
[INAUDIBLE] A PHYSICIAN WORKING
IN THE COMMUNITY EXPRESSED THE
CONCERN LIKE THIS.
IN THE U.S. OR EUROPE, WHOEVER
HAS THE DISEASE IN THEIR FAMILY
HAS THE OPTION TO DECIDE, I WANT
TO GET THE TEST OR I DON'T WANT
TO KNOW.
THE PEOPLE OF MARACAIBO DON'T
HAVE THAT OPTION EVEN AFTER THEY
COLLABORATED IN THE RECENT --
THESE CASES ILLUSTRATE TWO
ETHICAL ISSUES THAT ARE VERY
SALIENT IN RESEARCH WITH
POPULATIONS THAT LACK ACCESS TO
GOOD QUALITY CARE OUTSIDE OF
RESEARCH STUDIES.
AND THAT INCLUDES MANY
POPULATIONS IN LOW AND MIDDLE
INCOME COUNTRIES.
IT CAN ALSO INCLUDE GROUPS IN
HIGH-INCOME COUNTRIES THAT LACK
ACCESS TO AFFORDABLE HEALTHCARE,
BUT I'M NOT GOING TO FOCUS ON
THOSE CASES TODAY.
THE FIRST ETHICAL ISSUE IS THE
ISSUE OF POST TRIAL ACCESS, WHAT
CARE SHOULD PATIENTS RECEIVE
AFTER A STUDY, ARE THEY ENTITLED
TO CONTINUE TRE TREATMENT.
SECOND THE ISSUE OF REASONABLE
AVAILABILITY.
SHOULD THEY HAVE ACCESS TO STUDY
INTERVENTIONS AFTER A SUCCESSFUL
STUDY?
SO I'LL START BY DISCUSSING --
ACCESS TO CARE FOR TRIAL
PARTICIPANTS AND I'M GOING TO
PRIMARILY FOCUS TO THE
INTERVENTION THAT'S BEING TESTED
IN THE STUDY, OF COURSE THAT'S
NOT THE ONLY SORT OF CARE THAT
PARTICIPANTS MAY LEAVE A TRIAL
NEEDING.
FIRST WHAT DO THE GUIDELINES AND
REGULATIONS SAY ABOUT THIS ISS
ISSUE?
THE DECLARATION OF HELSINKI, THE
WORLD MEDICAL ASSOCIATION, THE
ETHICAL PRINCIPLES THEY THINK
SHOULD GOVERN RESEARCH MENTIONED
ALREADY BY ANNETTE.
EXTREMELY HELPFUL DOCUMENT USED
BY IRBs, MENTIONED IN
REGULATIONS ALL AROUND THE WOR
WORLD.
THE 2013 VERSION OF THE
DECLARATION STATES, IN ADVANCE
OF A CLINICAL TRIAL, SPONSORS
RESEARCHERS AND HOST COUNTRY
GOVERNMENTS SHOULD MAKE
PROVISIONS FOR POST TRIAL ACCESS
FOR ALL PARTICIPANTS WHO STILL
NEED INTERVENTION IDENTIFIED AS
BENEFICIAL IN THE TRIAL.
NOW, AT THE NATIONAL LEVEL,
THINGS ARE MUCH LESS CLEARCUT
THAN THEY ARE WITH THE
DECLARATION OF HELSINKI.
MOST NATIONAL REGULATIONS FOR
HUMAN SUBJECTS RESEARCH ARE
SILENT ON THE ISSUE.
SO FOR EXAMPLE, THE COMMON RULE
SAYS NOTHING ABOUT POST-TRIAL
ACCESS.
OTHER REGULATIONS MAY ENCOURAGE
PROVISION, REQUIRE RESEARCHERS
TO MAKE EFFORTS TO TRANSITION --
TO CARE OR SIMPLY REQUIRE THE --
OF INFORMATION.
THERE IS A LEGAL REQUIREMENT TO
PROVIDE FIRST TRIAL ACCESS FOR
PARTICIPANTS IN CURRENTLY
ARGENTINA, BRAZIL, CHILE, PERU
AND INDIA.
I'VE NOT SEEN MUCH DATA ON THE
IMPLEMENTATION OF THOSE
REGULATIONS IN ARGENTINA, CHILE,
INDIA AND PERU.
IT IS STILL RELATIVELY RECENT IN
THOSE COUNTRIES.
IN BRAZIL, THE ENTITY WITH THE
LEGAL DUTY TO PROVIDE POST TRIAL
ACCESS IS FREQUENTLY DISPUTED,
WHICH LEAVES PHARMACEUTICAL
COMPANIES SUING THE GOVERNMENT,
THE GOVERNMENT SUING
PHARMACEUTICAL COMPANIES.
POST TRIAL ACCESS TO SUCCESSFUL
INTERVENTIONS IS ALSO
RECOMMENDED BY NATIONAL
GUIDELINES IN SOME LOW AND
MIDDLE INCOME COUNTRIES.
FOR EXAMPLE, IN SOUTH AFRICA AND
UGANDA.
NOW, THOSE RECOMMENDATIONS ARE
NOT LEGALLY BINDING, BUT LIKE
THE DECLARATION OF HELSINKI,
THEY CAN BE RELIED UPON BY
RESEARCH ETHICS COMMITTEES WHO
THEN HAVE THE POWER TO
DISAPPROVE RESEARCH.
-- I'LL MENTION ONE WHICH IS
NIH'S GUIDANCE.
THIS DATES BACK TO 2005, THAT I
BELIEVE IS STILL [INAUDIBLE].
NOW THE NIH GUIDANCE APPLIES
VERY NARROWLY.
IT'S WRITTEN ONLY FOR THE
PROVISION OF ANTIRETROVIRAL
TREATMENT AND APPLIES ONLY TO
THE PROVISION OF ANTIRETROVIRAL
TREATMENT IN HIV TREATMENT
TRIALS, THOUGH NOT, FOR EXAMPLE,
TO TREATMENT FOR PEOPLE WHO
CONTRACT HIV IN PREVENTION
TRIALS.
AND IT APPLIES ONLY TO
DEVELOPING COUNTRIES, SO NOT,
FOR EXAMPLE, TO STUDIES IN THE
U.S.
THE GUIDANCE STATES, THE NIH
EXPECTS INVESTIGATORS OR
CONTRACTORS TO ADDRESS THE
PROVISION OF ANTIRETROVIRAL
TREATMENT TO TRIAL PARTICIPANTS
AFTER THEIR COMPLETION OF THE
TRIAL.
THE NIH RECOMMENDS THAT
INVESTIGATORS OR CONTRACTORS
WORK WITH HOST COUNTRIES,
AUTHORITIES AND OTHER
STAKEHOLDERS TO IDENTIFY
AVAILABLE SOURCES OF
ANTIRETROVIRAL TREATMENT.
PRIORITY MAY BE GIVEN TO SITES
WHERE SOURCES ARE IDENTIFIED FOR
THE PROVISION OF ARL TREATMENT L
TREATMENT FOLLOWING THE
COMPLETION OF THE TRIAL.
SO THAT IS WHAT SOME OF THE
REGULATIONS AR GUIDELINES SAY
ABOUT POST TRIAL ACCESS, WHAT
SHOULD WE MAKE IT FROM THE POINT
OF VIEW OF ETHICS.
>> MANY RESEARCHES, ETHICISTS,
THINK THAT THERE IS A DUTY TO
PROVIDE POST TRIAL -- EFFECTIVE
TREATMENT TO TRIAL PARTICIPANTS
WHO NEED IT.
PROVIDING A JUSTIFICATION FOR
THAT DUTY HAS PROVEN MORE
CHALLENGING.
NOW MULTIPLE -- I'M GOING TO
QUICKLY DISCUSS FOUR THAT HAVE
BEEN RAISED BY ETHICISTS AND I
SUGGEST -- WITH USING THOSE --
WITH USING THOSE JUSTIFICATIONS.
I'LL THEN SAY SOMETHING ABOUT
HOW POST TRIAL ACCESS PLAYS OUT
IN PR PRACTICE.
THE FIRST IS BASED UPON AVOIDING
HARM TO PARTICIPANTS.
THAT SOMEONE HAS A CHRONIC
DISEASE AND THEY'RE BENEFITING
FROM THE TREATMENT THAT THEY'RE
ON IN A TRIAL, THEN TAKING THEM
OFF THE TREATMENT.
WOULD HARM
THEM.
THIS IS ARGUED WOULD VIOLATE THE
DUTY OF NON-MALEFICENCE.
IF SOMEONE IS CONTROLLED BY HRT
REGIMEN, TAKING THEM OFF WILL
LEAD TO RESURGENCE OF DISEASE.
THIS JUSTIFICATION IS VERY
COMMON.
BUT I THINK IT'S USUALLY A MI
STAY KEP JUSTIFICATION.
THE REASON THAT IT M MISTAKEN IS
MANY, PERHAPS MOST OF THE CASES
IN WHICH POST TRIAL ACCESS WOULD
BE DESIRABLE, PARTICIPATING IN
THE TRIAL IN THE FIRST PLACE
BENEFITED PARTICIPANTS RELATIVE
TO HOW THEY WOULD OTHERWISE BE.
SO SUPPOSE THAT WE ARE
EVALUATING PROPOSED TRIAL OF AN
ANTIHYPERTENSIVE DRUG THAT'S
UNAPPROVED AND SO UNLIKELY TO BE
AVAILABLE VERY SOON TO
PARTICIPANT IN CLINICAL TRIALS.
YOU A SEUM THE DRUG TURNS OUT TO
BE UNAVAILABLE AND THERE AREN'T
GOOD -- AVAILABLE OUTSIDE THE
TRIAL.
IN THAT CASE IF THE PARTICIPANTS
WERE NOT -- THEY WOULD BE
WITHOUT ACCESS TO THE BENEFICIAL
TREATMENT.
BEING IN THE TRIAL PROVIDED
ACCESS TO THAT TREATMENT FOR A
WHILE.
IT'S PLAUSIBLE THAT THEY ARE
THEN BETTER OFF EVEN IF THEY
DON'T GET ACCESS AFTER THE TRIAL
AND THIS IMPLIES TRIAL
PARTICIPATION ITSELF DOES NOT
HARM THEM SO THE DUTY OF
NON-MALEFICENCE IS NOT VIOLATED.
A SECOND AND MORE PLAUSIBLE --
IN THE SPECIAL RELATIONSHIP
BETWEEN RESEARCHERS AND THEIR
PARTICIPANTS THAT DEVELOPS
DURING THE COURSE OF A STUDY.
THIS IS ANALOGOUS TO THE
RELATIONSHIP BETWEEN DOCTORS AND
THEIR PATIENTS.
SO JUST AS A DOCTOR HAS A
SPECIAL DUTY WITH REGARD TO THE
WELL-BEING OF HER PATIENT, SO A
RESEARCHER HAS A SPECIAL DUTY
WITH REGARD TO THE WELL-BEING OF
HER SUBJECTS.
RECEIVING CLINICAL CARE AND SO
ON.
CLEARLY THEN THE DUTY SHOULD BE
GREATER WHEN A STUDY HAS BEEN
LONG, THAT ALSO FITS WITH HOW
RESEARCHERS TEND TO FEEL -- A
LONG-STANDING RELATIONSHIP WITH
A PARTICIPANT GENERATES A
STRONGER DUTY.
THERE ARE TWO CHALLENGES THAT I
SEE IN APPEALING TO A SPECIAL
RELATIONSHIP BETWEEN RESEARCHERS
AND PARTICIPANTS IN ORDER TO
GROUND A SPECIAL DUTY OF
RESEARCHERS TO PROVIDE POST
TRIAL ACCESS TO CARE.
IS THAT THE ROLE OF A RESEARCHER
DIFFERENT THAN A CLINICIAN.
THE PRIMARY GOAL OF RESEARCH IS
TO CONDUCT SCIENCE TO BENEFIT
FUTURE PATIENTS.
THE WELL-BEING OF RESEARCH
PARTICIPANTS IS NORMALLY A
SECONDARY GOAL OR A CONSTRAINT
ON THE PURSUIT OF THAT PRIMARY
GOAL.
BY CONTRAST, THE PRIMARY GOAL OF
CLINICAL CARE IS TO HELP THE
PATIENT CURRENTLY IN FRONT OF
THE CLINICIAN.
INSOFAR AS THE TWO ARE
DISANALOGOUS THEN, WE WOULD
EXPECT THE SPECIAL OBLIGATIONS
OF A RESEARCHER TO BE WEAKER
THAN THOSE OF A CLINICIAN.
THE OTHER CHALLENGE IS THAT I'M
NOT CONVINCED THAT CLINICIANS
HAVE OPEN-ENDED OBL GAIGS TO
THEIR PATIENTS.
AT LEAST IN THE U.S., IT SEEMS
AS THOUGH WHEN SOMEONE LOSES
THEIR INSURANCE, THAT PRIMARY
CARE DOCTOR DOESN'T HAVE AN
OBLIGATION TO THEN PROVIDE CARE
TO THEM FOR FREE.
AND MOST, THERE'S A DUTY NOT TO
ABANDON ONE'S PATIENT, SO TO
ENSURE A TRANSITION TO OTHER
SOURCES OF CARE.
SO I THINK THIS IS A POSSIBLE
GROUND FOR POST TRIAL OBL GAIGS
OF RESEARCHERS, IT'S POTENTIALLY
A WEAK GROUND.
THIRD, SOME ETHICISTS SITE A E A
DUTY -- ONE APPROPRIATE WAY TO
PROVIDE THIS MIGHT BE BY
PROVIDING ADDITIONAL MEDICAL
CARE TO THEM AFTER THE TRIAL IS
COMPLETE.
AGAIN, I THINK THIS IS A
PLAUSIBLE GROUND FOR POST TRIAL
OBLIGATIONS.
ONE IMPORTANT CHALLENGE, THOUGH,
IS IT'S NOT GOING TO GROUND
OPEN-ENDED OBLIGATIONS AND NOT
THE SAME OBLIGATIONS IN EVERY
CASE.
IF WE'RE RECIPROCATING FOR THE
CONTRIBUTION OF THE
PARTICIPANTS, THEN THE EXTENT OF
THE OBLIGATION TO BENEFIT THEM
IS GOING TO DEPEND ON THE EXTENT
OF THEIR CONTRIBUTION.
AND THIS, I THINK, WE COULD
ANALYZE IN TERMS OF FACTORS LIKE
THE BURDEN THEY TOOK ON BY
PARTICIPATING THE RISKS THEY
UNDERTOOK AND SO ON.
NOTNOTE ALSO THAT IT'S NOT JUST
EVEN MOSTLY RESEARCHERS WHO
WOULD HAVE THIS OBLIGATION,
SINCE OTHER PARTIES ALSO BENEFIT
FROM THE CONTRIBUTION OF
RESEARCH PARTICIPANTS.
AT THE VERY LEAST, THE SPONSORS
OF RESEARCH, LIKE PHARMACEUTICAL
COMPANIES, WOULD SHARE THE
OBLIGATION TO RECIPROCATE.
AND MAYBE GOVERNMENTS WOULD TOO,
BECAUSE THEY'RE MAKING USE OF
THE PRODUCTS OF RESEARCH WITHIN
HEALTHCARE SYSTEMS.
OKAY.
FOURTH, A DUTY TO PROVIDE POST
TRIAL ACCESS MIGHT BE GROUNDED
IN A DUTY OF B BENEFICENCE, THAT
IS CALLED THE DUTY TO RESCUE.
CLASSIC CASE TO ILLUSTRATE THIS
DUTY IS AS FOLLOWS.
IMAGINE I'M ON MY WAY TO GIVE
THIS TALK, I WALK PAST A LARGE
POND ANDED IN THE POND, I NOTICE
A CHILD DROWNING.
NO ONE ELSE IS AROUND.
NOW I COULD WADE INTO THE POND
AND SAVE THE CHILD BUT I'M
WEARING A PRETTY NICE SUIT
THAT'S GOING TO BE RUINED IF I
RESCUE THE CHILD, AND THAT'S A
REASONABLE AMOUNT OF MONEY.
HERE'S THE POINT.
EVEN IF IT'S GOING TO RUIN MY
SUIT, I HAVE A MORAL DUTY TO
WADE IN AND RESCUE THE CHILD.
THE ETHICIST PROVIDES A NICE
STATEMENT OF THIS DUTY.
HE WRITES, IF IT'S IN OUR POWER
TO PREVENT SOMETHING BAD FROM
HAPPENING WITHOUT THEREBY
SACRIFICING ANYTHING MORALLY
SIGNIFICANT, WE OUGHT, MORALLY,
TO DO IT.
SO NOW APPLYING THIS PRINCIPLE
TO THE CASE AT HAND, RESEARCHERS
MAY BE IN A POSITION TO GIVE
URGENTLY NEEDED TREATMENT, SO
CONTINUING CARE MIGHT BE
LIFE-SAVING, FOR EXAMPLE, AND
RESEARCH PARTICIPANTS MAY NOT
HAVE ACCESS TO OTHER SOURCES OF
TREATMENT OUTSIDE OF THE TRIAL.
SO THE DUTY TO RESCUE MAY GROUND
POST-TRIAL OBLIGATIONS.
TWO CHALLENGES SHOULD BE
MENTIONED REGARDING THE DUTY TO
RESCUE IN THIS CONTEXT.
FIRST, IT WILL APPLY ONLY IN
CASES WHERE PROVIDING THE
INTERVENTION IS RELATIVELY LOW
COST.
AND THE BENEFIT IT PROVIDES IS
VERY HIGH.
BUT REALLY EXPENSIVE
INTERVENTIONS OR INTERVENTIONS
THAT PROVIDE ONLY MARGINAL
BENEFIT, THIS WON'T JUSTIFY A
DUTY TO PROVIDE CARE.
WE NEED CASES THAT ARE ANALOGOUS
TO THE RESCUING OF THE DROWNING
CHILD.
SECOND, THE DUTY TO RESCUE --
THAT SOMEONE CAN PROVIDE A GREAT
BENEFIT THAT'S NOT SPECIFIC TO
RESEARCH SUBJECTS.
SO FOR EXAMPLE, IF THE
RESEARCHERS IN A PARTICULAR
COUNTRY ARE STUDYING HEART
DISEASE BUT THE LOCAL COMMUNITY
NEEDS DESPERATELY
ANTIMALARIALS -- COULD MEAN THEY
HAVE A DUTY TO RESCUE EVEN TO
PEOPLE WHO ARE NOT IN THEIR
RESEARCH STUDY.
AND CLINICIANS, NGOs,
GOVERNMENT AGENCIES, ANYONE ELSE
IN A PROGRESSES TO PROVIDE AID
CAN EQUALLY HAVE A DUTY TO
RESCUE, SO IT'S NOT JUST
RESEARCHERS.
THIS TABLE SUGGESTS WHY THERE
MIGHT BE AN ETHICAL DUTY TO
PROVIDE CARE TO POST TRIAL
PARTICIPANTS WHO MIGHT NOT HAVE
ACCESS TO CARE OTHERWISE.
-- SPECIAL RELATIONSHIP BETWEEN
[INAUDIBLE] DUTY OF RECIPROCITY
MIGHT GROUND OBLIGATIONS TO
RESEARCHERS.
THESE DUTIES ARE GOING TO BE
LIMITED IN THEIR EXTENT.
THE DUTY TO RESCUE MAY
OCCASIONALLY APPLY, BUT IT WON'T
BE LIMITED -- SORRY -- BUT IT
WILL BE LIMITED TO URGENT NEEDS
AND IT WON'T BE LIMITED JUST TO
PARTICIPANTS.
SO SOME KEY POINTS I WANT TO
EMPHASIZE FROM THIS ETHICAL
ANALYSIS OF POST TRIAL ACCESS.
RESEARCHERS THEMSELVES DON'T
HAVE AN OBLIGATION TO CONTINUE
PROVIDING CARE FOR THE NEXT 30
YEARS, FOR EXAMPLE.
FURTHER, NONE OF THE
JUSTIFICATIONS IMPLY THAT THE
BEST OR THE ONLY WAY TO
DISCHARGE RESEARCHERS POST TRIAL
OBLIGATIONS IS BY PROVIDING THE
STUDY INTERVENTION.
IT MIGHT BE IN SOME CASES LIKE
WITH THE ANTIRETROVIRAL STUDY,
BUT IN OTHER CASES, ESPECIALLY
WITH STUDIES WHERE THE STANDARD
OF CARE IN THE TRIAL IS HIGHER
THAN OUTSIDE -- OTHER CARE
OUTSIDE MIGHT BE MORE VALUABLE.
FINALLY, THIS IS NOT A MATTER
JUST FOR THE RESEARCHERS.
WE NEED TO CONSIDER THE DUTIES
OF MULTIPLE PARTIES, INCLUDING
THE RESEARCHERS BUT ALSO
SPONSORS, NATIONAL GOVERNMENTS
WHO ARE RESPONSIBLE FOR
PROVIDING CARE FOR THEIR
CITIZENS.
CURRENT PRACTICE WITH REGARD TO
PROVIDING POST TRIAL ACCESS TO
EXPERIMENTAL PRODUCTS IS HIGHLY
VARIABLE.
MANY RESEARCH AT SITES AROUND
THE WORLD, THE FOCUS IS ON
TRANSITIONING PARTICIPANTS WHO
TILL NEED CARE TO OTHER SOURCES
OF CARE.
SO THESE MIGHT BE NATIONAL
HEALTHCARE SYSTEMS OR THERE
MIGHT BE OTHER STUDIES FOR WHICH
PARTICIPANTS ARE NOW ELIGIBLE.
RESEARCH SITES MAY, THEREFORE,
PROVIDE SHORT TERM CARE DURING A
TRANSITION PERIOD BUT NOT FOR
EXTENDED PERIODS OF TIME.
SOME COMPANIES HAVE ENSURED
CONTINUED ACCESS TO BENEFICIAL
TREATMENTS FOR SERIOUS
CONDITIONS BY RUNNING OPEN LABEL
EXTENSION STUDIES.
AGAIN, THOUGH, THIS IS CERTAINLY
NOT A CONSISTENT PRACTICE.
IN HIGH-INCOME COUNTRIES, IT'S
LIKELY -- THROUGH EXPANDED
ACCESS PROGRAMS OR, IN THE U.S.,
COMPASSIONATE USE PROGRAMS UNTIL
DRUGS GET LICENSED.
FINALLY, PERCEIVED OBLIGATIONS
TO ENSURE POST TRIAL ACCESS HAVE
ALSO LED PUBLIC AND PRIVATE
SPONSORS TO AVOID CARRYING OUT
RESEARCH IN CONTEXT WHERE
PATIENTS DON'T HAVE ACCESS TO
EFFECTIVE CARE OUTSIDE OF THE
TRIAL.
I WANT TO FLAG THIS BECAUSE I
THINK IT'S A POTENTIALLY
UNFORTUNATE EFFECT OF DEMANDING
THAT RESEARCH SPONSORS PROVIDE
POST TRIAL CARE.
POTENTIAL FOR PEOPLE WHO ALREADY
LACK ACCESS TO CARE TO GET
PENALIZED AGAIN BY NOT GETTING
ACCESS TO CARE THROUGH RESEARCH.
SO PUSHING FOR POST TRIAL ACCESS
CUTS BOTH WAYS.
LET ME RETURN NOW TO THE CASE TO
WHICH WE BEGAN.
THE DRUGS IN QUESTION -- THEY
AGREED TO PROVIDE THE DRUGS THAT
WERE NOT LICENSED IN COUNTRY FOR
FREE, BUT THEY DID NOT WANT TO
BE INVOLVED WITH DISTRIBUTION OF
THE DRUGS.
THAT WOULD HAVE TO BE DONE BY
THE RESEARCH TEAM.
THE SPONSOR, ON THE OTHER HAND,
WAS NOT ALLOWED TO PROVIDE
CLINICAL CARE OUTSIDE OF A
RESEARCH STUDY.
SO THEN AFTER CONSIDERABLE
NEGOTIATION, THE FOLLOWING
ARRANGEMENT WAS REACHED.
RESEARCHERS DESIGNED AN
EXTENSION STUDY TO PROVIDE THE
MANUFACTURER'S DRUGS WITH THE
GOAL OF TESTING WHETHER THE
PARTICIPANTS REMAINED VIRALLY
SUPPRESSED FOR TWO FURTHER
YEARS.
AND THE IDEA WAS THAT TWO YEARS
SHOULD BE ENOUGH TIME FOR THE
DRUGS TO BE LICENSED IN COUNTRY
AND PROVIDED TO PATIENT THROUGH
NATIONAL PROGRAMS.
I'LL LEAVE YOU TO THINK ABOUT
WHETHER THAT WAS A SUFFICIENT
ARRANGEMENT.
SO I'M GOING TO NOW LEAVE BEHIND
THE ISSUE OF WHAT CARE IS OWED
TO PARTICIPANT WHO LEAVE A TRIAL
STILL IN NEED OF CARE AND TURN
TO THE ISSUE OF WHAT IS OWED TO
THE COMMUNITIES THAT HOST
RESEARCH.
AND TO A LARGE EXTENT, THIS
DISCUSSION IS FOCUSED ON THE
ISSUE OF MAKING STUDY
INTERVENTIONS AVAILABLE TO HOST
COMMUNITIES.
NOW THERE ARE A FEW GUIDELINES
AND REGULATIONS THAT SPEAK TO
THIS QUESTION.
TWO OF THE MOST IMPORTANT SETS
OF INTERNATIONAL GUIDELINES DO
HAVE RELEVANT CLAUSES.
HERE'S THE DECLARATION OF
HELSINKI AGAIN.
WHICH SAYS, MEDICAL RESEARCH
WITH A VULNERABLE GROUP IS ONLY
JUSTIFIED IF THE RESEARCH IS
RESPONSIVE TO THE HEALTH NEEDS
OR PRIORITIES OF THIS GROUP AND
THE RESEARCH CANNOT BE CARRIED
OUT IN A NON-VULNERABLE GROUP.
IN ADDITION, THIS GROUP SHOULD
STAND TO BENEFIT FROM THE
KNOWLEDGE, PRACTICES OR
INTERVENTIONS THAT RESULT FROM
THE RESEARCH.
THE SECOND PIECE OF EXTREMELY
INFLUENTIAL NATIONAL GUIDANCE
COMES FROM THE COUNCIL -- THEIR
2002 GUIDELINES SAID BEFORE
UNDERTAKING RESEARCH IN A
POPULATION OR COMMUNITY WITH
LIMITED RESOURCES, THE SPONSOR
AND THE INVESTIGATOR MUST MAKE
EVERY EFFORT TO ENSURE THAT THE
RESEARCH IS RESPONSIVE TO THE
HEALTH NEEDS AND THE PRIORITIES
OF THE POPULATION OR COMMUNITY
IN WHICH IT IS TO BE CARRIED
OUT, AND ANY INTERVENTION OR
PRODUCT DEVELOPED OR KNOWLEDGE
GENERATED WILL BE MADE
REASONABLY AVAILABLE FOR THE
BENEFIT OF THAT POPULATION OR
COMMUNITY.
SO WHAT'S THE REASONING BEHIND
THESE RECOMMENDATIONS THAT THE
POPULATION OR COMMUNITY SHOULD
GUESS ACCESS TO THE PRODUCTS OR
RESEARCH?
I THINK THE UNDERLYING CONCERN
ABOUT CONDUCTING RESEARCH WHERE
IT'S NOT EXPECTED THAT THE HOST
COMMUNITY WOULD GET ACCESS TO
THE PRODUCT OF RESEARCH IS A
CONCERN ABOUT EXPLOITATION.
WHAT DOES IT MEAN FOR ONE PARTY
TO EXPLOIT ANOTHER OR FOR A
TRANSACTION TO BE EXPLOITED
UPON?
A STANDARD ANALYSIS DEFINES
EXPLOITATION ABOUT THIS.
X EXPLOITS Y WHEN X TAKES UNFAIR
ADVANTAGE OF Y'S SITUATION.
SO THE PARTY DOING THE
EXPLOITING TAKES ADVANTAGE OF
SOME VULNERABILITY OF THE OTHER
PARTY IN ORDER TO GET MORE OUT
OF HIM THAN SHE DESERVES.
SO FOR EXAMPLE, SUPPOSE MY CAR
GETS STUCK IN THE MUD IN A
REMOTE -- ON A REMOTE COUNTRY
ROAD AND PHYLLIS IS THE ONLY
PERSON WITH A TOW TRUCK.
I MIGHT BE VULNERABLE BECAUSE I
HAVE NO OTHER WAY TO GET OUT OF
THE MUD.
IT MIGHT BE MILES AND MILES TO
THE NEAREST TOWN.
I WON'T BE ABLE TO GET THERE
WITHOUT MY CAR.
THERE'S NO OTHER PROS PEBT OF PF
RESCUE AND SO ON.
SUPPOSE THAT SHE CHARGES ME
$1,000 FOR 10 MINUTES' WORK TO
PULL ME OUT.
ASSUME ALSO I'M CARRYING $1,000
WITH ME IN CASH AND DON'T ASK
WHY THIS WOULD BE THE CASE.
NOW I MIGHT BE WILLING TO PAY
THAT MUCH, BUT SHE SURELY IS
TREATING ME WRONGLY.
AND THE WRONG HERE, I THINK, IS
THAT SHE'S EXPLOITING ME, SHE
TAKES UNFAIR ADVANTAGE OF MY
SITUATION TO GET MORE OUT OF HER
INTERACTION THAN SHE SHOULD.
NOW, NOTICE A COUPLE OF
IMPORTANT POINTS ABOUT
EXPLOITATION THAT THIS EXAMPLE
BRINGS OUT.
DOES EXPLOITATION HAVE TO BE
HARMFUL TO THE PERSON WHO'S
EXPLOITED?
NO, I'M NOT HARMED BY PHYLLIS
EXPLOITING ME, I'M BENEFITED.
THAT'S WHY I AGREE TO PAY THE
THOUSAND BUCKS.
I DON'T SEE THIS IS GOING TO BE
A POTENTIALLY LIFE SAVING
RESCUE.
DOES EXPLOITATION INVOLVE VALID
CONSENT?
I MIGHT -- I MIGHT DO IT
VOLUNTARILY BUT STILL BE
EXPLOITED.
IT'S POSSIBLE TO HAVE WHAT'S
CALLED MUTUALLY ADVANTAGEOUS
CONSENSUAL EXPLOITATION.
OKAY.
SO WE RETURN NOW TO THE QUESTION
OF EXPLOITATION OF COMMUNITIES
THAT HOST RESEARCH.
THEY WILL BE EXPLOITED IF THEY
RECEIVE AN UNFAIR LEVEL OF
BENEFITS FROM THE RESEARCH
RELATIVE TO THE BURDENS OF
HOSTING THE RESEARCH, AND
RELATIVE TO THE GAINS TO OTHER
PARTIES.
GAINS TO OTHER PARTIES MIGHT BE
COMPANIES WHO PROFIT FROM
DEVELOPING A SUCCESSFUL DRUG,
PATIENTS IN OTHER COUNTRIES
BENEFIT FROM THE DRUG BEING
DEVELOPED AND SO ON.
WHAT SOURCE OF BURDENS MIGHT
COMMUNITIES FACE OVER AND ABOVE
THE RISKS AND BURDENS FACED BY
RESEARCH PARTICIPANTS
THEMSELVES?
WELL, THE RESEARCH MAY MAKE USE
OF CLINICAL FACILITIES THAT ARE
SCARCE, LOCAL HEALTHCARE
PRACTITIONERS ARE HIRED FOR THE
RESEARCH, IT MAY ATTRACT THEM
AWAY FROM THE PUBLIC HEALTH
SYSTEM AND CONTRIBUTE TO A LOCAL
BRAIN DRAIN.
THERE'S A LIMIT OF HOW MUCH
RESEARCH CAN TAKE PLACE AT ANY
ONE SITE, SO RAO SEARCH THAT
DOESN'T HAVE HIGH SOCIAL VALUE
MIGHT CROWD OUT MORE VALUABLE
RESEARCH.
NOW OF COURSE THERE ARE POSSIBLE
BENEFITS TO HOST COMMUNITIES
TOO.
SO A RESEARCH STUDY MIGHT --
LOCAL HEALTH PROBLEMS THAT ARE
IMPORTANT TO THE HOST COMMUNITY,
SO FOR EXAMPLE, ANSWERED
QUESTIONS ABOUT THE EPIDEMIOLOGY
OF A DISEASE, PUBLIC INFORMATION
CAMPAIGNS.
THE RESEARCH MAY BE PART OF THE
PROCESS OF DEVELOPING NEW
MEDICAL INTERVENTIONS FOR THE
POPULATION THAT WILL BENEFIT
PATIENTS IN THAT COMMUNITY.
RATHER THAN TAKING [INAUDIBLE].
THE INFRASTRUCTURE THAT'S USED
FOR THE -- LOCAL HEALTHCARE
WORKERS MAY GET ADDITIONAL
TRAINING.
OKAY.
SO REQUIRING THAT RESEARCH ONLY
BE CONDUCTED WHEN THE PRODUCTS
OF RESEARCH WILL BE MADE
REASONABLY AVAILABLE TO PATIENTS
IN HOST COMMUNITIES, I THINK IS
TRYING TO AVOID EXPLOITATION, BY
ENSURING THAT THE BENEFITS OF
HOST COMMUNITY ARE FAIR, GIVEN
THE BENEFITS THAT OTHER PARTIES
RECEIVE, GIVEN THE BURDENS THAT
ARE TAKEN ON BY HOSTING
RESEARCH.
THE IDEA I TAKE IT IS THAT THE
BENEFITS OF GETTING ACCESS TO
NEW INTERVENTIONS THAT ARE
IMPORTANT FOR THE HEALTH OF
PEOPLE IN THE COMMUNITY IS
NORMALLY A SUFFICIENT BENEFIT TO
AVOID EXPLOITATION.
FURTHER, THE REQUIREMENT FOR
REASONABLE AVAILABILITY HAS COME
IN FOR SOME CRITICISM.
FOR ONE IT'S NOT GOING TO BE
RELEVANT TO SOME RESEARCH.
SO FOR EXAMPLE, IT DOESN'T APPLY
TO PHASE ONE TRIALS SINCE
NORMALLY THE PRODUCTS THAT MAKE
IT THROUGH PHASE ONE HAVE NOT
YET SHOWN EFFICACY.
IT WON'T APPLY TO EMDEEM LOGICAL
STUDIES SINCE THERE'S NO
ASSOCIATED PRODUCT.
SOMETIMES THERE WILL BE NO
BENEFITS BY MAKING AN
EXPERIMENTAL INTERVENTION
AVAILABLE.
FOR EXAMPLE, IF IT'S NOT SHOWN
TO BE EFFECTIVE.
THE REQUIREMENT HAS ALSO BEEN
CRITICIZED FOR PUTTING AN
EXCESSIVE BURDEN ON RESEARCHERS
AND SPONSORS.
IT'S NOT THEIR JOB, IT'S ARGUED,
TO PROVIDE DRUGS TO EVERYONE IN
THE POPULATION THAT WOULD
BENEFIT FROM THEM.
IT'S NOT THEIR JOB TO ENSURE
THAT THE LOCAL HEALTH SYSTEM
PROVIDES THE DRUGS.
FINALLY, THE REASONABLE
AVAILABILITY REQUIREMENT HAS
BEEN CRITICIZED FOR TAKING A
VIEW OF THE BENEFITS THAT COUNT
THAT IS TOO NARROW.
ACCORDING TO THE ACCOUNT OF
EX-EMPLOY TAKES THAT WE'RE
WORKING WITH, WHETHER OR NOT
SOMEONE IS EXPLOITED BY A
TRANSACTION DEPEND ON THE AMOUNT
TO WHICH SHE BENEFIT RELATIVE
TO -- NOTHING ON THE ACCOUNT
RELIES ON THE BENEFIT TO HER
BEING OF A PARTICULAR TIME.
INDEED, IT'S INSISTING THAT THE
BENEFITS BE IN THE FORM OF
PROVIDING THE EXPERIMENTAL
INTERVENTION THAT LEADS TO THE
PROBLEM WITH RESEARCH THAT
DOESN'T YIELD A PRODUCT.
SOME OF THESE OPTIONS HAVE BEEN
ADDRESSED IN THE MOST RECENT
REVISIONS TO THE CM IOS
GUIDELINES WHICH CLARIFY THE
REASONABLE -- THEY NOW SAY AS
PART OF THEIR OBLIGATION,
SPONSORS AND RESEARCHERS MUST
ALSO MAKE EVERY EFFORT IN
COOPERATION WITH GOVERNMENT AND
OTHER RELEVANT STAKEHOLDERS TO
MAKE AVAILABLE AS SOON AS
POSSIBLE ANY INTERVENTION OR
PRODUCT DEVELOPED AND KNOWLEDGE
GENERATED FOR THE POPULATION OR
COMMUNITY IN WHICH THE RESEARCH
IS CARRIED OUT, AND TO ASSIST IN
BUILDING LOCAL RESEARCH
CAPACITY.
BUT OF COURSE THIS DOES NOT DEAL
WITH THE OBJECTION THAT WHAT
MATTERS IS THE AMOUNT, NOT THE
TYPE OF BENEFIT.
AND HERE IS THE DEBATE.
SOME ETHICISTS THINK WE SHOULD
ALLOW A MUCH WIDER RANGE -- THEY
THINK EXPLOITATION COULD BE
AVOIDED BY SUPPORTING A CLINIC
TO PROVIDE ADDITIONAL HEALTHCARE
OR BY IMPROVING THE -- WATER.
OTHERS THINK ONCE WE LOOSEN
RESTRICTIONS ON WHAT BENEFITS
COUNT, THERE'S A RISK OF
COMMUNITIES GETTING A RAW DEAL.
BIG POWER DISPARITIES BETWEEN
THE HIGH-INCOME COUNTRIES, THE
HIGH INCOME COUNTRY INSTITUTIONS
AND THE COMPANIES THAT FUND
INTERNATIONAL RESEARCH AND THE
HOST COMMUNITIES IN
LOW/MIDDLE-INCOME COUNTRIES
WHERE THEY TAKE PLACE.
IF WE DON'T HAVE A STANDARD FOR
WHAT'S FAIR, AND IF RESEARCH
SPONSORS ARE ABLE TO SHOP AROUND
DIFFERENT COMMUNITIES FOR A GOOD
DEAL, THEN WE RISK A RACE TO THE
BOTTOM.
WE RISK, THAT IS, THE POWERFUL
SPONSORS OF RESEARCH BARGAINING
DOWN THE BENEFITS THAT THEY
PROVIDE TO HOST COMMUNITIES.
-- ALSO MIDDLE POSITIONS
BETWEEN THESE TWO.
WE CALL THAT THE REASONABLE
AVAILABILITY REQUIREMENT, IT WAS
ORIGINALLY ONE HALF OF A
TWO-PART REQUIREMENT.
THAT RESEARCH SHOULD BE
RESPONSIVE TO POST RESEARCH
NEEDS AND -- SHOULD BE
REASONABLY AVAILABLE.
IF YOU'RE CONVINCED BY THE
CRITICISMS OF REASONABLE
AVAILABILITY BUT NOT CONVINCED
THAT WE SHOULD ALLOW JUST ANY
TYPE OF BENEFIT TO HOST
COMMUNITIES TO COUNT, THEN YOU
MIGHT TURN TO THE FIRST OF THESE
REQUIREMENTS TO HELP YOU OUT.
SO NO MATTER WHAT ELSE YOU MIGHT
SAY, RESEARCH SHOULD BE
RESPONSIVE TO THE HEALTH NEEDS
OF THE POPULATION IN WHICH THE
RESEARCH IS CARRIED OUT.
NOW HERE'S HOW WE NEED TO THINK
ABOUT RESPONSIVENESS.
I LIKE TO THINK ABOUT IT IN
TERMS OF THE LOCAL SOCIAL VALUE.
SO YOU ALREADY HAVE TALKED ABOUT
THE SOCIAL VALUE REQUIREMENT FOR
RESEARCH, ACCORDING TO WHICH THE
KNOWLEDGE THAT A RESEARCH STUDY
IS EXPECTED TO GENERATE SHOULD
BE SUFFICIENTLY VALUABLE BY
ASKING PARTICIPANTS TO TAKE ON
THE RISKS AND BURDENS OF
PARTICIPATION.
SO THE IDEA HERE IS THAT WE CAN
ALSO THINK IN TERMS OF LOCAL
SOCIAL VALUE.
VALUE OF THE KNOWLEDGE THAT THE
RESEARCH GENERATES TO THE
COMMUNITY THAT HOSTS THE
RESEARCH.
IF THE VALUE OF THAT KNOWLEDGE,
WHETHER IT'S FROM
EPIDEMIOLOGICAL RESEARCH OR
IMPLEMENTATION RESEARCH OR
DEVELOPING NEW PRODUCTS, THE
VALUE OF THAT KNOWLEDGE IS
SUFFICIENTLY GREAT, THEN THE
RESEARCH WON'T BE EXPLOITIVE.
IT MAY BE EASIER TO WORK OUT
WHETHER RESEARCH HAS SUFFICIENT
LOCAL SOCIAL VALUE THAN WHETHER
AN AMOUNT OF BENEFITS BEING
OFFERED TO A COMMUNITY IS FAIR.
IF THAT'S RIGHT, THEN THIS IS A
REASON WE SHOULD CARE ABOUT
RESPONSIVENESS.
ON THE OTHER HAND, IF WE THINK
IN PRINCIPLE ANY TYPE OF BENEFIT
SHOULD COUNT FOR DETERMINING
WHETHER THE BENEFITS TO A
COMMUNITY ARE SUFFICIENT THAT'S
A REASON TO BE MORE LIBERAL
ABOUT WHAT COUNTS AND TO TRY TO
PUT IN PLACE PROTECTIONS SO IN
PRACTICE, IT DOESN'T LEAD TO
EXPLOITATION.
SO THERE'S MUCH MORE TO SAY
ABOUT THIS DISCUSSION, BUT I'M
GOING TO WRAP UP.
TWO TAKE-HOME POINTS ABOUT
REASONABLE AVAILABILITY.
FIRST, THAT IT'S HARD TO JUSTIFY
REQUIRING THAT RESEARCHERS OR
SPONSORS ENSURE THAT STUDY
PRODUCTS THAT ARE SHOWN
EFFECTIVE MUST HAVE MADE
REASONABLY AVAILABLE TO
COMMUNITIES OR POPULATIONS THAT
HOST RESEARCH.
SECOND, THOUGH, I THINK IT'S
ALSO HARD TO JUSTIFY RESEARCH
THAT'S NOT RELEVANT TO THE
HEALTH OF HOST COMMUNITIES IN
LOW/MIDDLE-INCOME COUNTRIES.
IN PRACTICE, ASKING THE
QUESTION, WHAT IS THE RELEVANCE
OF THIS RESEARCH TO THE
POPULATION IN WHICH IT'S BEING
CARRIED OUT TURNS OUT TO BE A
GOOD WAY TO AVOID [INAUDIBLE], A
GOOD WAY TO IDENTIFY WAYS IN
WHICH A RESEARCH PROJECT SHOULD
BE -- IN ORDER TO GIVE IT MORE
SOCIAL VALUE.
RETURN NOW TO THE SECOND CASE
WITH WHICH I STARTED THIS TALK,
THE HUNTINGTON'S TEST CASE.
MOST PEOPLE IN MARACAIBO KNOW
ABOUT THE TEST AND NONE HAVE
ACCESS TO IT.
THE ORIGINAL GOAL OF FINDING A
CURE HAS NOT BEEN ACHIEVED, SO
THEY DON'T HAVE A TEST THAT WAS
DEVELOPED FOR MEMBERS OF THE
COMMUNITY.
ON THE OTHER HAND, THE
RESEARCHER WHO LED THE PROJECT
RAISED A LARGE AMOUNT OF MONEY,
MORE THAN $6 MILLION, TO SUPPORT
A HUNTINGTON'S DISEASE CLINIC
THERE.
ONE WOULD THINK THIS BENEFIT TO
MEMBERS OF THE COMMUNITY IS
LARGE ENOUGH THAT WE WOULD NOT
SAY THAT SHE HAD EXPLOITED THE
COMMUNITY.
TO CONCLUDE, THERE IS WIDESPREAD
AGREEMENT THAT BOTH PARTICIPANTS
IN CLINICAL TRIALS AND
COMMUNITIES THAT HOST RESEARCH
STUDIES SHOULD BENEFIT FROM
RESEARCH PARTICIPATION.
AND I'VE TALKED ABOUT SOME OF
THE WAYS IN WHICH PEOPLE THINK
THEY SHOULD BENEFIT AND WHY, OR
WHAT GROUNDS ARE THOSE REASONS
TO THINK THEY SHOULD BENEFIT.
THERE'S DISAGREEMENT ABOUT THE
TYPE OF BENEFIT THAT SHOULD BE
PROVIDED AND THE EXTENT OF THAT
BENEFIT.
SO FOR EXAMPLE, HOW LONG A
SPONSOR SHOULD PAY FOR
EX-PARTICIPANTS TO RECEIVE CARE.
THERE'S ALSO DISAGREEMENT ABOUT
WHO HAS THE DUTY TO PROVIDE THE
BENEFIT.
FOR EXAMPLE, WHETHER IT
GOVERNMENTS OR WHETHER IT'S THE
RESEARCHERS AND THEIR SPONSORS.
FINALLY, I WANT TO SOUND A
CAUTIONARY NOTE ABOUT THE
ETHICAL ISSUES THAT HAVE BEEN
IDENTIFIED.
CONDUCTING RESEARCH IN
ENVIRONMENTS WHERE MANY PEOPLE
LACK ACCESS TO AFFORDABLE
QUALITY CARE IS ETHICALLY
CHALLENGING, I TONIGHT THINK DOT
SHOULD PUT US OFF.
CONDUCTING THIS RESEARCH IS ALSO
VITALLY IMPORTANT FOR IMPROVING
THE HEALTH OF PEOPLE IN LOW AND
MIDDLE INCOME COUNTRIES SO THE
ETHICAL CHALLENGES ARE
CHALLENGES THAT SHOULD BE MET,
NOT CHALLENGES THAT SHOULD BE
AVOIDED.
THANK YOU.
[APPLAUSE]
>> THANK YOU, JOE.
SORRY, I DIDN'T HAVE MY MIC ON.
THANK YOU, JOE.
AND WE HAVE LOTS OF TIME FOR
QUESTIONS.
SO JOE JUST FYI, WE HAVE OUR
CURRENT FIRST-YEAR FELLOWS IN
THE ROOM, AND THEN THOSE OUT IN
THE VIRTUAL WORLD CAN POST
QUESTIONS FOR ME EITHER IN THE
DISCUSSION BOARD OR BY EMAIL.
SO I INVITE FOLKS TO DO THAT.
ANY QUESTIONS HERE FROM THE
GROUP?
MARCOS LOOKS LIKE HE'S THINKING
VERY HARD ABOUT A GOOD QUESTION
TO ASK.
SO THERE IS A LITTLE LAG, JOE,
SORRY, BECAUSE WHEN FOLKS PUT IN
THEIR QUESTIONS INTO THE
DISCUSSION BOARD FROM WHEREVER
THEY ARE IN THE WORLD, THEY
DON'T ARRIVE AS QUICKLY AS IS
POSSIBLE.
SO IT SEEMS I'M GOING TO ASK YOU
A QUESTION, JOE.
>> GREAT.
>> SO IN THINKING ABOUT -- SO I
UNDERSTAND WHERE YOU LEFT US.
THE SORT OF IDEA THAT ON ONE
HAND, IT'S CHALLENGING, ON THE
OTHER HAND, WE DON'T WANT TO
FURTHER DISADVANTAGE
DISADVANTAGED GROUPS BY FAILING,
PERHAPS, TO CONSIDER THAT -- A
PARTICULAR COMMUNITY AS ONE
WHERE WE MIGHT WANT TO DO
RESEARCH.
AND CAN YOU SAY A LITTLE MORE
ABOUT IF I'M AN INVESTIGATOR,
HOW WOULD YOU COUNSEL ME TO
THINK ABOUT -- LET'S IMAGINE I
HAVE A TRIAL WHERE I HAVE A
NUMBER OF DIFFERENT COMMUNITIES
I MIGHT START MY TRIAL, WHAT
SORT OF ADVICE WOULD YOU GIVE ME
ABOUT HOW I SHOULD THINK ABOUT
MAKING THE CHOICE OF WHICH SITES
TO CONDUCT MY TRIAL?
>> GREAT.
AND THAT'S A BIG QUESTION.
SO LET ME JUST SAY A COUPLE OF
THINGS AND THEN YOU CAN HONE IN
ON SOMETHING IF YOU LIKE.
I CAN NOW SEE ABOUT FOUR OF ME
TALKING BACK, WHICH IS ALSO
DISCONCERTING.
>> YEAH --
>> I'LL TRY TO CONVINCE MYSELF
AS WELL.
>> THERE'S SON SOME AV ISSUES .
SORRY ABOUT THAT.
>> NO WORRIES, NO WORRIES AT
ALL.
SO I THINK ONE THING IS, IF
YOU'RE THINNING ABOUT DIFFERENT
SITES WHERE YOU MIGHT SITUATE
RESEARCH, WE WANT TO HAVE AT
LEAST TWO GOALS, ONE OF WHICH IS
A SORT OF MAXIMIZING GOAL, AND
ONE OF WHICH IS A GOAL IN TERMS
OF ETHICAL CONSTRAINTS.
THE MAXIMIZING GOAL IS THAT WE
SHOULD BE, I THINK, MOST CONC
CONCERNED WITH MAKING SURE THAT
THE RESEARCH IS GOING TO BE
PRODUCING KNOWLEDGE THAT IS
VALUABLE, AND THAT THAT
KNOWLEDGE SHOULD BE IDEALLY
VALUABLE TO THE GREATEST NUMBER
OF PEOPLE AND TO PEOPLE WHO ARE
MOST DISADVANTAGED, OR IF YOU'RE
LIKE MOST IN NEED OF THE
KNOWLEDGE THAT'S BEING
GENERATED.
AND SOMETIMES THAT'S GOING TO
HELP US TO DECIDE BETWEEN
DIFFERENT POPULATIONS, RIGHT?
DEPENDING ON WHAT KNOWLEDGE IS
GOING TO BE GENERATED, WHAT
WE'RE GOING TO BE ABLE TO GET
DATA THAT'S -- WHAT THE DATA
THAT WE GET IS GOING TO BE
RELEVANT TO TELLING US.
BUT THE OTHER THING IS THAT
WITHIN THAT, RIGHT, WE'RE TRYING
TO DO THE MOST SOCIALLY VALUABLE
RESEARCH WE CAN.
WITHIN THAT, WE CAN ELIMINATE
THE RESEARCH STUDIES WHERE
CONDUCTING THE RESEARCH IN THAT
POPULATION WOULD JUST BE
UNETHICAL.
SO WE HAVE THE MAXIMIZING GOAL
BUT WE ALSO HAVE TO HAVE THE
CONSTRAINT OF NOT WANTING TO
CONDUCT UNETHICAL RESEARCH.
NOW THAT GOAL, THE NOT DOING
UNETHICAL RESO MUCH GOAL IS RESS
REALLY STRAIGHTFORWARD -- WE
WANT TO MAKE SURE WE'RE NOT
IMPOSING EXCESSIVE HARMS ON
PARTICIPANTS, IF WE WOULD, THEN
WE WOULDN'T CARRY OUT THE
RESEARCH.
THE CHALLENGE IS, WHEN THE GOAL
OF GENERATING SOCIALLY VALUABLE
KNOWLEDGE COMES INTO CONFLICT
WHERE THE GOAL OF RESPECTING
ETHICAL CONSTRAINTS.
THIS IS WHERE THINGS LIKE THE
ISSUE OF THE STANDARD OF CARE OR
ISSUES ABOUT EXPLOITATION COME
UP.
BECAUSE THE TWO ARE RELATED,
WHICH POPULATION WE CONDUCT
RESEARCH IN AFFECTS WHAT SOCIAL
VALUE WE GET OUT OF THE
RESEARCH, BUT WHETHER WE CONDUCT
RESEARCH IN A PARTICULAR
POPULATION, RIGHT, IT GOING TO
CHANGE HOW WE DESIGN THE STUDY
AND, THEREFORE, WHETHER WE
RISK -- IF IT'S EXPLOITIVE, ET
CETERA, ET CETERA.
SO LAST THING TO SAY IS, I THINK
THERE IS A DANGER SOMETIMES OF
TRYING TO KEEP ONE'S HANDS CLEAN
IN THE SENSE OF NOT TAKING ANY
RISK OF DOING RESEARCH IN A
POPULATION WHERE YOU CAN'T
PROVIDE THE VERY BEST TO THEM,
AND MY CAUTIONARY NOTE AT THE
END WAS, I THINK WE SHOULD BE
WARY OF THAT.
IT'S GREAT TO HAVE CLEAN HANDS,
BUT IF THAT COMES AT THE COST OF
NOT GENERATING SOCIALLY VALUABLE
INFORMATION THAT CAN HELP
POPULATIONS THAT ARE MOST IN
NEED, THEN YOU'VE GOT CLEAN
HANDS BUT YOU'VE GOT THIS REAL
COST TO THE PEOPLE YOU COULD
HAVE BENEFITED.
I DON'T KNOW IF THAT'S HELPFUL
IN ANSWERING YOUR QUESTION,
HOLLY, BUT THOSE ARE MY SORT OF
INITIAL VERY BIG PICTURE
THOUGHTS.
>> NO, THAT'S GREAT, AND IN
FOLLOW-UP, I COULD MAKE A -- IF
I'M THE RESEARCHER, RIGHT, I
COULD HEAR THAT AND SAY, OKAY,
SO WHEN I'M CONSIDERING THE
SITES, I MIGHT THINK ABOUT WHICH
OF THE SITES IS THE LEAST WELL
OFF, AND WILL MY GOING TO THAT
PARTICULAR COMMUNITY RESULT IN A
LEVEL OF SOCIAL VALUE THAT IS
THAT MUCH MORE THAN IF I GO TO
SOME OF THESE OTHER SITE, BUT I
ALSO HAVE TO BE AWARE THAT THEY
ARE THE LEAST WELL OFF, AND BE
CAUTIOUS ABOUT EXPLOITATION OR
EVEN MAYBE THE PERCEPTION OF
EXPLOITATION, AND BE TRANSPARENT
ABOUT THAT IN THE SENSE OF
SAYING, THIS IS THE
JUSTIFICATION FOR WHY I'M GOING
TO THIS PLACE, YOU KNOW, WE'RE
GOING TO HEAR FROM DORCAS IN A
MOMENT.
I HAVE COMMUNICATED THIS WITH
THE COMMUNITY, AND I FEEL
CONFIDENT THAT CONDUCTING THE
RESEARCH HERE CAN BE DONE AT A
STANDARD THAT'S ACCEPTABLE AND I
AM COMMITTED TO MAKING SURE THAT
THE KNOWLEDGE THAT I GENERATE IS
FED BACK INTO THE POPULATION.
RIGHT?
OR I COULD SAY, WOW, IT TRICKY
GOING TO THE LEAST WELL OFF
COMMUNITY.
I'M GOING TO GO TO ONE THAT IS
BETTER OFF AND AGAIN APPRECIATE
THAT THE SOCIAL VALUE THAT I MAY
GENERATE FOR THAT LOCAL
COMMUNITY IS A QUANTITY BUT NOT
AS HIGH AS THE OTHER.
SO I GUESS TO SAY, RIGHT, YOU
GAVE ME SOME GOOD THOUGHTS ABOUT
HOW I COULD BE THINKING ABOUT
THOSE TRADEOFFS IN MAKING A
JUSTIFICATION FOR GOING TO SOME
SITE OVER ANOTHER.
SO I NOW HAVE SOME QUESTIONS.
I HAVE ANOTHER QUESTION BUT
THESE ARE FROM OUR VIRTUAL
PARTICIPANTS.
THIS IS AN INTERESTING QUESTION.
SO THIS IS FROM DALEEP WHO SAYS,
IN TRADITIONAL MEDICINE
RESEARCH, INDIGENOUS KNOWLEDGE
MAY BE COMMERCIALIZED OR PATE
PATENTED.
IN SUCH CASE, HOW TO DEAL WITH
THE POST RESEARCH BENEFIT
SHARING AND ACCESS.
DO YOU HAVE ANY THOUGHTS ABOUT
THAT?
>> WOW, YEAH.
ALSO A BIG QUESTION.
>> WE GIVE YOU ALL THE BIG ONES,
JOE.
>> GREAT.
SO THERE'S SORT OF A
LONGSTANDING AND VERY LEGITIMATE
CONCERN ABOUT RESEARCH THAT IS
EXPLOITIVE OF VARIOUS
COMMUNITIES INCLUDING INDIGENOUS
COMMUNITIES, AND ONE PARTICULAR
WAY IN WHICH THAT EXPLOITATION
HISTORICALLY HAS HAPPENED IS
WHERE A KNOWLEDGE THAT MAY HAVE
BEEN HELD WITHIN THAT INDIGENOUS
COMMUNITY, WHETHER IT'S HELD BY
A SMALL NUMBER OF INDIVIDUALS IN
THE COMMUNITY OR COMMONLY KNOWN,
THAT KNOWLEDGE IS TAKEN, USED TO
MAKE A PRODUCT, THAT PRODUCT IS
PA AT THE PRESENT TIMED AND
PROFITS ARE MADE ON THE BASIS OF
IT.
AND THEN THE CONCERN IS THOSE
PROFITS DON'T LEAD TO ANY
ADDITIONAL BENEFITS TO THE
COMMUNITIES.
NOW, THERE'S OF COURSE A REALLY
BIG PICTURE QUESTION WHICH IS
ABOUT WHETHER WE THINK THE
EXISTING INTELLECTUAL PROPERTY
REGIMEN, THE PATENT SYSTEM, IS
THE RIGHT WAY TO BE
INCENTIVIZING RESEARCH IN THE
FIRST PLACE.
RIGHT?
SO WE CAN HAVE A BACK
CONVERSATION, I THINK THERE ARE
A LOT OF LEGITIMATE QUESTIONS
WHETHER EVEN IN HIGH-INCOME
COUNTRIES, WHETHER THAT'S THE
SYSTEM THAT WE SHOULD BE USING
TO INCENTIVIZE RESEARCH.
SUPPOSE YOU ACCEPT THAT PATENTS
ARE AN ACCEPTABLE WAY TO
INCENTIVIZE PRIVATE SECTOR
RESEARCH.
THEN THERE STILL HAS TO BE
BENEFIT SHARING ARRANGEMENTS IN
PLACE WHEN THOSE PATENTS ARE
DEVELOPED ON THE BASIS OF
KNOWLEDGE THAT OTHER PEOPLE
CONTRIBUTED.
AND THAT SEEMS TO ME TO BE JUST
A MATTER OF STRAIGHT-UP FAIRNESS
OR JUSTICE.
I CAN'T SPEAK TO THE SPECIFICS
OF HOW THIS CAN BE DONE.
THERE ARE SOME GUIDE LINES THAT
EXIST WITH RESPECT TO THIS.
THE -- PEOPLE IN SOUTHERN AFRICA
HAVE THEIR OWN SET OF ETHICAL
GUIDELINES FOR RESEARCHERS WHO
WANT TO INTERACT WITH THEM THAT
CAME OUT IN LARGE PART AS A
RESULT OF THEIR PERCEPTION THAT
THEIR INDIGENOUS KNOWLEDGE WAS
BEING USED, SO I THINK THAT'S A
GOOD PLACE TO LOOK FOR HOW ONE
GROUP HAS DESCRIBED THE PROBLEM,
DESCRIBED HOW THEY WANTED TO BE
APPROACHED.
I WOULD SAY IT'S DEFINITELY A
POTENTIAL PROBLEM, IT'S A
QUESTION OF EXPLOITATION AND
IT'S A QUESTION OF FAIR
TREATMENT, AND ONE WAY I THINK
WE SHOULD BE REALLY CAREFUL
ABOUT EXTRACTING KNOWLEDGE,
COMMERCIALIZING IT AND NOT
PROVIDING ANYTHING IN RETURN.
>> GREAT.
THANK YOU.
AND I THINK WE HAVE -- WE'LL GO
WITH ONE MORE QUESTION AND IF WE
HAVE TIME WE'LL DO A SECOND.
SO THIS IS FROM YOLANDA.
SHE SAYS, I WOULD APPRECIATE IT,
IF POSSIBLE, TO SHARE A LITTLE
MORE ABOUT, QUOTE-UNQUOTE, THAT
EXPLOITATION NOT BE HARMFUL.
IS IT THE CASE THAT PARTICIPANTS
COULD DEMAND MORE THAN IT WOULD
BE NEEDED IN REALITY FOR THEM,
THAT IS MORE BENEFITS THAN THEY
MIGHT NEED, BUT HOW WOULD
EXPLOITATION NOT BE HARMFUL FROM
THE SIDE OF THE RESEARCHERS?
IS THERE A WAY THAT THEY COULD
OVERPLAY THEIR HAND?
OR --
>> YEAH.
SO THE IDEA OF EXPLOITATION
WHERE EXPLOITATION INVOLVES ONE
PARTY TAKING UNFAIR ADVANTAGE OF
THE OTHER IS THAT SOME OF THE
TIME EXPLOITATION IS -- A LOT OF
THE TIME A TRANSACTION IS
EXPLOITIVE BUT, IN FACT, BOTH
PARTIES ARE BETTER OFF.
SO IF YOU THINK ABOUT THE CASE
OF EXPLOITIVE LABOR CONTRACT,
WHERE SOMEONE IS PAID MUCH LESS
THAN, SAY, THE MINIMUM WAGE,
WELL, MADE BETTER OFF PLAUSIBLY
BY ACCEPTING THE LOWER WAGE
BECAUSE OTHERWISE THEY WOULDN'T
ACCEPT IT, BUT THEY'RE STILL
BEING EXPLOITED, THEY'RE STILL
BEING TREATED UNFAIRLY.
NOW, YOU COULD INCREASE THE
BENEFITS THAT ARE PROVIDED TO
THAT PARTY, RIGHT, IN THE SAME
WAY AS YOU WOULD INCREASE THE
BENEFITS TO HOST COMMUNITIES.
AND YOU COULD INCREASE TO THE
POINT WHERE THEY'RE GETTING MORE
THAN THEIR FAIR SHARE, RIGHT?
THAT'S STILL NOT GOING TO HARM
THE SPONSORS OF THE RESEARCH,
NOT GOING TO HARM THEM TO THE
PERSON WHO'S EMPLOYING THEM,
BECAUSE THEY MAY STILLING
BENEFITING.
A PART OF BENEFITS TO BE
DIVIDED, QUESTIONS HOW IT SHOULD
BE DIVIDED FAIRLY.
SO YOU COULD HAVE LARGE
INCREASES IN THE BENEFITS
PROVIDED TO THE PREVIOUSLY
EXPLOITED PARTY, WITHOUT IT THEN
LEADING TO THE OTHER PARTY
FAILING TO BENEFIT FROM THE
TRANSACTION.
IF THEY FAIL TO BENEFIT FROM THE
TRANSACTION, PRESUMABLY THEY
WOULDN'T ENGAGE IN IT IN THE
FIRST PLACE.
>> EXACTLY.
>> THAT'S SPEAKING TO THE
QUESTION.
>> YEAH.
YES, RIGHT.
SO, YOU KNOW, IF A -- SO AGAIN
BACK TO HOLLY, IF HOLLY IS GOING
TO MULTIPLE COMMUNITIES AND ONE
SAYS YOU CAN COME TO MY
COMMUNITY BECAUSE WE APPRECIATE
THE SOCIAL VALUE BUT WE WANT IN
EXCHANGE FOUR NEW WELLS AND FOR
YOU TO COMMIT TO MAKING SURE
THOSE WELLS REMAIN FUNCTIONING
FOR THE NEXT 10 YEARS.
I, HOLLY, MIGHT SAY, YOU KNOW, I
ACTUALLY DON'T HAVE FUNDS
AVAILABLE TO DO THAT.
THAT'S NOT SOMETHING I'M GOING
TO BE ABLE TO DO, AND SO I NEED
TO GO TO THE NEXT COMMUNITY OR I
SAY, WOW, BEING IN THIS
COMMUNITY IS REALLY IMPORTANT TO
ME.
I KNOW I CAN'T USE RESEARCH
FUNDS TO DIG AND MAINTAIN THOSE
WELLS, BUT MAYBE I WOULD START A
CAMPAIGN TO CREATE A FUND TO DO
JUST THAT.
SO I APPRECIATE THE SORT OF
THINKING ABOUT I, HOLLY, AM
ALWAYS GOING TO BENEFIT, SO THE
VALUE IN TERMS OF MY ABILITY TO
BE EXPLOITED IS SO MUCH LARGER
THAN WHAT I COULD EVER OFFER THE
COMMUNITY IN THIS CASE.
>> I DON'T WANT TO SOUND TOO
MUCH LIKE AN ECONOMIST ABOUT
THIS BUT IT'S ABOUT DIVIDING UP
A SURPLUS, THE SOCIAL SURPLUS
FROM THE INTERACTION WE'RE GOING
TO HAVE AND THE QUESTION IS HOW
DO YOU DIVIDE IT UP BETWEEN THE
DIFFERENT PARTIES.
WE WANT TO MAKE SURE THE POWER
RELATIONS DON'T LEAD TO
UNFAIRNESS.
>> EXACTLY.
SO ONE OTHER QUESTION, SO AS YOU
KNOW IN THE COURSE WE TALK ABOUT
THE ROLE OF THE IRB, I'M
WONDERING IF YOU COULD TALK A
LITTLE ABOUT HOW AN IRB OUGHT TO
BE THINKING ABOUT THIS SORT OF
EXCHANGE OF BENEFITS AND WHAT
MIGHT BE REASONABLE IN AN
ASSESSMENT OF WHAT'S GOING TO BE
EXCHANGED BETWEEN THE TWO
PARTIES.
>> THIS REALLY IDENTIFYING ONE
OF THE CHALLENGES WITH THE
QUESTION OF POST TRIAL ACCESS
AND THE QUESTION OF REASONABLE
AVAILABILITY, WHICH IS ONCE YOU
MOVE INTO A SITUATION WHERE WE
DON'T HAVE IT STRAIGHTFORWARD
WE'RE GOING DO THIS RAO SEARCH
AND IF IT'S SUCCESSFUL THE
PRODUCTS OF THE RESEARCH WILL BE
AVAILABLE TO YOU, ONCE WE'RE OUT
OF THAT SIMPLE PARADIGM, IT
BECOMES REALLY HARD TO LOOK AT
WHAT LEVEL OF BENEFITS IS
APPROPRIATE.
UTS REALLY IT'S REALLY HARD FORO
KNOW WHAT SHOULD THEY PERMIT IN
TERMS OF BENEFITS OR LACK OF
BENEFITS TO HOST COMMUNITIES OR
BENEFITS OR LACK OF BENEFITS TO
PARTICIPANTS.
NOW WE SAY ONE THING ABOUT WHAT
MAKES THIS VERY COMPLICATED AND
THEN I'LL SUGGEST HOW I'D LIKE
TO THINK ABOUT THIS.
ONE THING THAT MAKES IT
COMPLICATED IS YOU COULD -- SO
YOU CAN'T JUST RELY ON WHAT
PARTICIPANTS ARE WILLING TO
ACCEPT OR WHAT HOST COMMUNITIES
ARE WILLING TO ACCEPT.
AND THAT'S PRECISELY BECAUSE OF
THE CONCERN ABOUT EXPLOITATION.
RIGHT?
YOU COULD HAVE COMMUNITIES
WILLING TO ACCEPT AN EXPLOITIVE
LEVEL OF BENEFITS BECAUSE THEY
REALLY WANT THE BENEFITS, AND
SAME WITH PARTICIPANTS.
SO THE EASY ANSWER OF WE'LL JUST
SEE WHAT PEOPLE AGREE TO ISN'T
AVAILABLE WHEN YOU WANT TO KNOW
WHAT'S FAIR, NOT JUST WHAT IS
GOING TO BENEFIT TO PEOPLE
RELATIVE TO THE STATUS QUO.
IN TERMS OF SOLUTIONS, I THINK
ONE WAY TO THINK ABOUT IT THAM I
DESCRIBED IN MY TALK WHICH I
THINK CAN BE HELPFUL IS TO THINK
ABOUT IT IN TERMS OF LOCAL
SOCIAL VALUE.
SO IF YOU WERE TO THINK ABOUT
THIS STUDY, AND IGNORE THE
EFFECTS OUTSIDE OF THE
POPULATION WHERE THE RESEARCH IS
GOING TO TAKE PLACE, SO JUST
FOCUS ON THE POPULATION, PANTS
PANTSPARTICIPANTS ARE DRAWN FROE
SITES SELECTED, WOULD THE
KNOWLEDGE OF VALUE BE ENOUGH
YOU'RE GOING TO IMPROVE THE
STUDY, THE IDEA OF LOCAL SOCIAL
VALUES.
SINCE IRBs ARE ALWAYS SUPPOSED
TO BE THINKING ABOUT SOCIAL
VALUE ANYWAY, THAT'S SOMETHING
THEY DO FOR EVERY STUDY, THAT'S
A WAY, A HEURISTIC FOR TRYING TO
THINK ABOUT HOW MUCH IS ENOUGH
LOCAL SOCIAL VALUE TO AVOID
EXPLOITATION.
AND THEN THE OTHER THING IS,
ALTHOUGH I THINK IT'S TRUE YOU
CAN'T JUST ASK WHAT WOULD
PARTICIPANTS ACCEPT OR WHAT
WOULD A COMMUNITY ACCEPT, THE
DEPARTMENT OF BIOETHICS
SUGGESTED DO THIS, YOU CAN ASK
THEM FOR THEIR JUDGMENTS ABOUT
WHAT THEY THINK IS FAIR.
AND THAT MAY BE ANOTHER WAY IN
PARTICULARLY CONTROVERTED CASES
OR PARTICULARLY LARGE TRIALS
WHERE PEOPLE ARE CONCERNED ABOUT
THIS, THAT MAY BE A WAY TO GET
SOME HANDLE ON WHAT THE LEVEL OF
BENEFITS OUGHT TO BE TO AVOID
EXPLOITATION.
>> GREAT.
WELL, THANK YOU AS ALWAYS, JOE,
FOR BEAMING IN FROM THE U.K.,
AND WE'LL SEE YOU SOON, I HOPE.
>> THANKS EVER SO MUCH FOR
HAVING ME.
IT'S ALWAYS GREAT TO TALK WITH
YOU ALL.
>> GOOD.
GREAT.
THANK YOU.
SO WE ARE AT THE TIME FOR OUR
BREAK, AND IF YOU COULD ALL
RETURN AT 10:35, THAT WOULD BE
GREAT.
I'M JUST GOING TO MENTION, AS I
DID AT THE TOP OF THE COURSE DAY
TODAY, THAT WE'RE GOING TO BE
USING SLIDO DURING DR. QU THE
PRESENTATION.
I SENT AN EMAIL TO EVERYONE ON
THIS.
YOU JUST NEED TO GO TO SLIDO.COM
ENTER THE SESSION NUMBER.
THERE'S ALSO A LINK IN THE EMAIL
THAT WILL TAKE YOU DIRECTLY TO
THE SESSION.
THE SESSION NUMBER IS 2060360.
I'LL REPEAT THAT WHEN WE'RE
ABOUT TO START WITH DR. KAMUYA,
BUT IT WILL BE GREAT IF YOU'RE
READY WITH SLIDO ON YOUR
COMPUTER OR PHONE BEFORE WE GET
STARTED.
SO THANK YOU ALL.
TOPICS INCLUDING,
CONTROLLED HUMAN INFECTION
STUDIES, PANDEMIC PREPAREDNESS
AND ALL SORTS OF THINGS, BUT SHE
IS VERY CAPABLE TO TALK TO US
TODAY ABOUT EXAMINING THE VALUE
OF COMMUNITY AND PUBLIC
ENGAGEMENT IN HEALTH RESEARCH.
SO I'M GOING TO HAND IT OVER TO
DORCAS, AND AS A REMINDER, WE'RE
GOING TO BE USING SLIDO AND THE
CODE IS 2060360.
THANK YOU, THANK YOU, HOLLY,
GOOD MORNING, GOOD AFTERNOON,
WHEREVER YOU ARE.
EVENING IN KENYA, SO I'M REALLY
EXCITED TO BE PART OF THIS.
THE PREVIOUS PRESENTERS,
PROFESSORS ANNETTE RID AND
JOSEPH SET A VERY GOOD
BACKGROUND OF WHY ENGAGEMENT IS
SO IMPORTANT IN HEALTH RESEARCH.
>> ALSO I'M DRAWING A LOT OF
EXPERIENCES OF MANY AMAZING
COLLEAGUES AND COLLABORATORS IN
THE WORK THAT WE DO.
CAN YOU STOP JUST FOR A SECOND?
CAN I ASK YOU TO PUT YOUR SLIDES
IN PRESENTATION MODE SO WE HAVE
THOSE HERE ON OUR SCREEN?
>> THANK YOU.
SO THIS IS -- THE COMMUNITIES --
SOME CONSIDERATIONS IN -- AND
IMPLEMENTING ENGAGEMENT.
A QUICK OUTLINE FOR MAIN AREAS
WE WILL COVER WHY ENGAGEMENT IN
HEALTH RESEARCH MATTERS, SOME
LIMITATIONS OF ENGAGEMENT.
PRIOR TO THIS SESSION, THERE'S A
VIDEO THAT WAS SHARED EARLIER
WHICH IS ABOUT SOME COMMUNITY
MEMBERS DISCUSSING WHAT -- -- KI
RESEARCH PROGRAM.
I HOPE YOU HAVE THE TIME TO
LISTEN TO THE VIDEO, IT'S
11.3 MINUTES CLIP, SO I THINK IN
SOME WAYS, IT STARTS TO GIVE A
FOUNDATION OF WHY ENGAGEMENT IS
SO IMPORTANT SM SO.
SO IN THE NEXT FEW MINUTES, --
ONE OF THE QUESTIONS, -- HOW
MIGHT ENGAGEMENT ASSIST
COMMUNITY MEMBERS IN THIS
CONTEXT AND HOW MIGHT IT ALSO
ASSIST RESEARCHERS IN THIS
CONTEXT.
ANYONE WHO CAN HELP ME HERE, WHO
CAN GIVE SOME FEEDBACK ON THIS.
>> WE'RE SET.
I HAVE A BUNCH OF RESPONSES SO
THANK YOU OUT THERE IN THE ROOM
AND IN VIDEO LAND.
SO HERE ARE A COUPLE SUGGESTIONS
FROM THE GROUP ABOUT ISSUES FOR
COMMUNITIES THAT EMERGE FROM THE
VIDEO.
WE HAVE STUDY PARTICIPANTS,
WE'WERENOT ADEQUATELY PERFORMED.
FROM THE VIDEO, THERE WAS HOOR
INFORMATION AND PERHAPS
MISCONCEPTIONS OF THE COMMUNITY
CONCERNING KEMRI ACTIVITIES.
THE VIDEO -- SOMEONE ELSE SAYS,
THEY DON'T FULLY UNDERSTAND.
THEY HAVE STRONGLY HELD ON TO
THEIR CULTURAL BELIEFS.
LET'S SEE.
SORRY.
WE'VE GOT LOTS OF ANSWERS SO I'M
TRYING TO SCROLL THROUGH HERE.
LOTS OF RUMORS OF INTENTIONAL
MISUNDERSTANDING, WHILE IT'S
TRUE THAT RESEARCH MAY REPRESENT
FOR COMMUNITIES' ACCESS TO
INNOVATIVE TREATMENTS, CULTURAL
DIFFERENCES AND RADICALISM MAY
CAUSE SUCH NOT TO BE ACCEPTED
AND HENCE THE IMPORTANCE OF A
COMMUNITY REPRESENTATIVE TO
ASSIST IN COMMUNITY OUTREACH.
I CAN GO ON.
THERE'S LOTS OF OTHER RESPONSES,
BUT --
>> THANK YOU.
THANK YOU, I REALLY APPRECIATE,
THESE ARE A FULL RANGE OF ISSUES
THAT THAT VIDEO PROVIDES AND
MAYBE BEFORE WE GO TO THE NEXT
ONE, A BIT OF ABOVE GROUND, THIS
IS A VIDEO THAT WE DEVELOPED IN
2005.
BY THE TIME WE SHOWED THIS VID
VIDEO, THE PROGRAM HAD BEEN IN
THE POPULATION FOR AROUND 10, 15
YEARS.
EVERY RESEARCH WAS ENGAGING --
WHAT THE RESEARCH INTENDED TO
DO.
BY ALL ACCOUNTS, RESEARCHERS ARE
VERY -- AND THEN WE DID THIS
VIDEO.
AND THAT ECONOMICALLY CHANGED
HOW WE VIEWED ENGAGEMENT.
SO JUST A BIT OF A BACKGROUND,
AND WHAT YOU SEE THERE IS
COMMUNITY MEMBERS DISCUSSING THE
WORK OF THE PROGRAM.
SO HOW MIGHT ENGAGEMENT
THEREFORE ASSIST COMMUNITY
MEMBERS IN THIS CONTEXT.
WHAT KIND OF ISSUES CAME UP?
WERE RESPONSIVE?
>> I WILL SHARE THEM WITH YOU
NOW.
WE HAVE IDENTIFYING ISSUES THAT
MATTER TO THE COMMUNITY.
HELPING INCREASING COMMUNITY
AWARENESS OF OTHER TYPES OF
MEDICINE AND TREATMENT.
LET'S SEE.
BEFORE THE STUDY BEGINS,
COMMUNITY ENGAGEMENT SHOULD BE
INITIATED TO PROVIDE DETAILED
INFORMATION ABOUT THE STUDY AND
THE STUDY PLAN.
COMMUNITY MEMBERS NEED TO FEEL
THEY HAVE A ROLE IN CONSIDERING
WHAT IS GOING TO BE CONDUCTED IN
THEIR SETTING.
AND IT'S IMPORTANT FOR THEM TO
UNDERSTAND THE PROJECT GOALS.
>> THANK YOU.
I THINK WHAT'S COMING IS THE
ROLE OF COMMUNITY BEING SO
CENTRAL TO WHAT IS HAPPENING IN
THEIR COMMUNITY, INCLUDING TO
THE ROLES OF THE RESEARCH AND
WHAT THE RESEARCH DOES.
ALSO WHAT I'M HEARING IS THE
ISSUE OF THEY WERE NOT AWARE, OR
THEY DIDN'T UNDERSTAND OR THEY
DIDN'T KNOW WHAT WAS HAPPENING
AND THEREFORE THEY HAVE ALL
THESE OTHER CONCERNS THAT WERE
EMERGING.
AND HOW MIGHT ENGAGEMENT ASSIST
RESEARCHERS?
>> GREAT.
SO WE AGAIN HAVE LOTS OF GREAT
RESPONSES.
SO IT HELPS RESEARCHERS
UNDERSTAND WHAT THE COMMUNITY
THINKS ABOUT RESEARCH.
LEARNING FROM THE SUBJECTS, MORE
TRANSPARENCY, MORE SUPPORT FROM
OTHER HEALTHCARE BODIES OR
HEALERS.
GIVES RESEARCHERS A BETTER
UNDERSTANDING OF THE UNIQUE
CULTURAL, SOCIAL AND OTHER
CONTEXTS OF THE COMMUNITY AND
EQUIP THEM TO COLLABORATE BETTER
WITH THE COMMUNITY IN RESEARCH
AND ALSO HELPS ENRICH THE
DESIGN, AND PERHAPS IMPROVING
THE SOCIAL VALUE, ACQUIRING
COMMUNAL SUPPORT, AND MAY BUILD
TRUST BETWEEN THE LOCAL
COMMUNITY AND THE RESEARCH TEAM.
>> THANK YOU, THANK YOU.
ALL VERY GREAT POINTS WHICH I
TOTALLY AGREE WITH.
PROVIDING A QUICK RECAP, --
CORRECT RESPONSES, OR PERHAPS --
GIVE INFORMATION AS MUCH AS WE
WANT, PEOPLE WILL UNDERSTAND AND
THE RUMORS WILL DISAPPEAR.
OUR EXPERIENCE SO FAR IS THAT
RUMORS ARE JUST A SYMPTOM OF
SOMETHING DEEPER, AND ENGAGEMENT
ITSELF CAN HELP YOU UNDERSTAND
WHAT IS THAT DEEPER ISSUES THAT
PEOPLE ARE CONCERNED ABOUT.
AND THAT COME OUT IN TERMS OF
RUMORS.
IT'S VERY EASY TO DISMISS
RUMORS, TO THINK WE DEVELOP
CAREFULLY CRAFTED -- AND
EVERYTHING WILL BE FINE.
IT'S GREAT TO HAVE THESE
MESSAGES, IT'S GREAT TO HAVE
INFORMATION SHARING SESSIONS,
BUT OVER AND ABOVE THAT, PERHAPS
WE NEED TO CONSIDER OTHER EXTRA
STEPS THAT NEED TO BE IN PLACE.
IN THE VIDEO I THINK YOU ALSO
HAD SOME OF THE PEOPLE SAYING OR
SOME OF THE COMMUNITY MEMBERS
SAYING THAT OUR STAFF THEMSELVES
ARE PART OF BRING RUMORS TO THE
COMMUNITY, THEY SAY WEIRD THINGS
HAPPEN IN THE WORLD.
AND IT BECAME REALLY CRITICAL TO
UNDERSTAND, IT'S VERY EASY TO BE
OUTWARD LOOKING, THINKING ABOUT
HOW PEOPLE THINK ABOUT THE WORK
OF THEIR RESEARCH BETTER THAN
EVEN THINKING ABOUT HOW DO
YOU -- VERY CLOSE PEOPLE WHO
WORK WITH THE RESEARCH, THE
DRIVERS, THE PEOPLE WHO ARE --
WHAT THEY THINK OF YOUR WORK,
AND WE THEREFORE THINK ABOUT
MULTIPLE LEVELS OF ENGAGEMENT
FROM COMMUNITIES, TO STAFF, TO
KEY STAKEHOLDERS, THE OTHER
THING THAT REALLY INFORMED OUR
ENGAGEMENT STRATEGY IS TO THINK
OF ENGAGEMENT NOT JUST LIKE A
SHORT QUICK FIX SOLUTION TO A
PROBLEM BUT RATHER A LONG TERM
INVESTMENT IN RELATIONSHIP
BUILDING, IN GENUINELY SEEKING
OPINIONS OF COMMUNITY MEMBERS
INVOLVING THEM IN SO MANY
DIFFERENT WAYS.
AND I THINK THIS VIDEO IN
ADDITION TO SOME FORMATIVE WORK
WE WERE DOING AT THE TIME WAS
REALLY INSTRUMENTAL IN HELPING
US AS AN INSTITUTION TO -- WHAT
ARE OUR GOALS IN THE COMMUNITY
AND WHAT DOES THAT AIM TO DO AND
HOW CAN THAT BE SUSTAINED OVER
TIME.
SO IT CHANGED FROMLESS DEVELOPED
IC MATERIALS, INFORMATION
MATERIAL THAT CAN GO OUT TO HOW
DO WE CREATE AND SUSTAIN
MEANINGFUL RELATIONSHIPS WITH
THE COMMUNITY.
SO THAT'S A QUICK OVERVIEW OF
HOW COMMUNITY ENGAGEMENT IS SO
IMPORTANT IN MANY WAYS.
WE HAVE DOCUMENTED ABOUT THAT,
I'M NOT GOING TO GO INTO
DETAILS.
I THINK COMING FROM HERE, ONE OF
THE THINGS WE'VE COME TO REALIZE
VERY EARLY ON IS THAT COMMUNITY
ENGAGEMENT IS ACTUALLY NOW IN
MANY SITUATIONS BEING CONSIDERED
AS A -- MOST RESEARCH
INSTITUTIONS WOULD BE REQUIRING
PIs, RESEARCHERS, TO THINK
CAREFULLY ABOUT ENGAGEMENT.
AND THIS COULD BE ABOUT
COMMUNITY ENGAGEMENT, PUBLIC
ENGAGEMENT.
IN THE NEXT FEW SLIDES, I'LL TRY
TO TEASE OUT THESE TWO TERMS A
LITTLE BIT.
BUT TERMS BEING USED
INTERCHANGEABLY.
SO IT'S GREAT TO THINK ABOUT
ENGAGEMENT, WHY DO WE NEED
ENGAGEMENT?
THE ELEMENTS OF ENGAGEMENT ARE
COMPLETELY CONTEXTED.
WHAT ARE THE GOALS, SOME OF THEM
COULD BE -- WHO DO WE NEED TO
ENGAGE, WHO IS THE COMMUNITY?
WHO ARE THE REPRESENTATIVES, HOW
ARE THEY ELECTED, WHAT DO THEY
REPRESENT?
HOW DO WE ENGAGE -- PEOPLE ARE
SO DIFFERENT IN ANY ONE SETTING.
IT COULD BE IN A HEALTH
FACILITY, PEOPLE HAVE GOT VERY
DIFFERENT WAYS OF WANTING TO
BE -- AND WE WORK WITH THAT.
COMMUNITY ENGAGEMENT, WE SAY
IT'S IMPLEMENTED PRAGMATICALLY.
>> I'M SORRY TO INTERRUPT,
DORCAS?
>> THE NEED FOR ENGAGEMENT, TALK
TO PEOPLE.
>> DORCAS?
I'M SORRY TO INTERRUPT AGAIN BUT
YOUR SLIDES ARE NOT MOVING
FORWARD.
I DON'T KNOW IF YOU WANT YOUR
SLIDES TO MOVE FORWARD BUT WE'RE
STILL ON THE VERY FIRST SLIDE.
>> OH, MY GOD.
OKAY.
CAN I JUST COME OFF THE MEETING
AND -- AGAIN?
BECAUSE I THINK --
>> SURE.
YOU'RE WELCOME TO DO THAT.
>> LET ME LEAVE AND THEN JOIN.
SORRY ABOUT THAT.
>> YOU'RE SHARING THE WRONG
SCREEN, DORCAS, ACCORDING TO AV.
SO IT MAY BE THAT YOU HAVE TWO
SETS OF YOUR POWERPOINT OPEN ON
YOUR SCREEN.
SO YOU MIGHT WANT TO CLOSE THOSE
OUT AND RE-OPEN THEM.
>> OKAY.
I'M GOING TO TRY TO LEAVE AND I
CAN'T LEAVE.
>> SO ALL WE SEE ON OUR SCREEN
NOW IS YOU.
WHICH IS TERRIFIC.
>> YES.
>> I CAN ALSO OPEN THE SLIDES ON
THE COMPUTER HERE IN THE ROOM,
AND YOU COULD TELL ME WHEN YOU
WOULD LIKE ME TO ADVANCE THEM.
WOULD YOU LIKE ME TO DO THAT?
>> YES, THAT'S FINE.
LET'S DO THAT.
>> GREAT.
LET ME JUST --
>> NONE OF THE BUTTONS ARE
WORKING FROM MY END NOW.
>> GREAT.
SO I'M GOING TO OPEN IT UP HERE.
YOU CAN TELL ME WAR TO ADVANCE
TO.
I'M CURRENTLY ON THE FIRST
SLIDE.
>> I THINK I'M UP TO WHERE --
COMMUNITY ENGAGEMENT CONTESTED.
>> WHAT I HAVE ON MY SCREEN
RIGHT NOW, DORCAS, IS THE RECAP
PRE-SESSION.
>> OKAY.
MOVE TO THE NEXT SLIDE.
>> OKAY.
SO NOW I'M ON -- I'M ON MANY
ELEMENTS OF COMMUNITY PUBLIC
ENGAGEMENT.
COMPLEX AND CONTESTED.
>> YES.
OKAY.
>> GREAT.
>> SO LET'S CONTINUE FROM THERE.
MOVE TO THE NEXT SLIDE.
>> NEXT SLIDE.
>> YES.
>> YEP.
WE'RE THERE.
>> YES.
AGAIN, NEXT.
NEXT.
YES.
SO WHY ENGAGE.
MOST OF THE GOALS THAT HAVE BEEN
PUT FOR ENGAGEMENT COULD BE
GROUPED INTO WHAT WE CALL
INSTRUMENTAL GOALS OR VALUES.
THESE ARE THE EASY ONES.
THESE COULD BE HEALTH POLICY AND
PRACTICE OR HEALTH RESEARCH, AND
I'LL GIVE AN EXAMPLE OF THAT.
BUT ALSO WHAT WE SEE AS
INTRINSIC VALUE.
THAT ENGAGEMENT IN ITSELF IS THE
RIGHT THING, IT'S A GOOD THING.
IF IT DOESN'T LEAD TO ANYTHING
ELSE, THE FACT THAT AS
RESEARCHERS WE ARE ENGAGING
COMMUNITIES IS A GOOD THING.
IT'S PART OF BEING A -- IN THAT
COMMUNITY, NOT SEEING YOURSELF
AS A SEPARATE ENTITY FROM WHAT
THE COMMUNITY ARE.
NEXT SLIDE.
WHAT HAPPENS WHAT WE CAN VERY
EASILY RELATE TO INSTRUMENTAL
VALUES OF COMMUNITY ENGAGEMENT,
PERHAPS YOU WANT TO SEE WHAT
YOU'RE PROPOSING IS RELEVANT AND
ACCEPTABLE TO THE POPULATION,
THE RESEARCH VALUES ARE
APPROPRIATE, HOW TO MAKE SURE
THAT APPROPRIATE POLICIES ARE
ETHICAL, ALSO YOU MIGHT WANT TO
BE DISCUSSING ABOUT BENEFITS OF
RESEARCH AND HOW THOSE PLAY OUT
IN HOUSEHOLD DYNAMICS AND
COMMUNITY DYNAMICS.
YOU MIGHT ALSO WANT TO CONSIDER
HOW YOUR RESEARCH PROGRAM IS
GOING TO BE EMBEDDED WITHIN
HEALTHCARE SYSTEMS, AND,
THEREFORE, NOT SUPPLANT -- THAT
HAVE BEEN -- TAKEN OVER THE
SERVICES OF THE HEALTH SYSTEM.
SO THESE ARE INCREDIBLE GOALS
FOR ENGAGEMENT.
THE HEALTH POLICY, YOU MIGHT BE
WANTING TO MEASURE THAT --
WHATEVER POLICY -- ARE BEING
PRESENTED, THEY HAVE GOT THE
BUY-IN OF THE COMMUNITY AND OF
THE POPULATIONS.
AND ALSO THINK ABOUT HOW
HEALTHCARE CAN BE EQUITABLE AND
SO OH.
SO ALL THOSE INSTRUMENTAL
VALUES.
EIGHT OF THEM IS BETTER, BUT
WHAT I'M SAYING IS AS MUCH AS
INSTRUMENTAL VALUES ARE EASY TO
PIN INTO, A LONG TIME INVESTMENT
IN ENGAGEMENT ALSO HELPS US
THINK ABOUT INTRINSIC VALUES.
SOMETIMES THEY ARE NOT
INTENTIONS, THEY JUST BUILD UP
INTO EACH OTHER.
SO HAVING SAID THAT, THEN WHO IS
A COMMUNITY?
YOU'RE GOING TO -- WHERE YOU
START FROM?
YOU GO TO A POPULATION, WHERE DO
YOU START FROM?
AND THERE ARE MANY DEFINITIONS
THAT HAVE BEEN GIVEN ABOUT
COMMUNITY.
SOME OF THEM ARE PART OF THE
GEOGRAPHIC REGION OR WHETHER THE
POPULATION IS OR SPECIAL
INTEREST OR PEOPLE WHO ARE
DEFINED BY PERHAPS YOUR RESEARCH
INTERESTS, IT COULD BE ABOUT A
SPECIFIC DISEASE AND THEREFORE
YOU'RE LOOKING FOR --
CONDITIONS.
IT'S ALSO IMPORTANT TO -- HOW
WE'RE DEFINING COMMUNITIES AS
RESEARCHERS MAY NOT ALWAYS BE
HOW COMMUNITIES THEMSELVES SEE
THAT.
AND SO WE SAY THERE IS WHAT YOU
CALL YOUR -- OF A COMMUNITY AND
THAT IS VERY COMMON, AND IT
COULD BE THAT YOUR BOND INTO A
CERTAIN TRIBE, A CERTAIN --
WHICH HAS GOT A CERTAIN WAY OF,
YOU KNOW, THEIR CULTURE AND
CUSTOMS AND THEREFORE -- DEFINED
BY YOUR INITIAL COMMUNITY.
MAY NOT NECESSARILY SEE
THEMSELVES AS -- AS WHAT THEY
ARE DEFINING COMMUNITY.
AND I GUESS WHAT I'M TRYING TO
POINT OUT IS THAT IT IMPORTANT
TO ALWAYS BE -- THAT'S THE WAY
WE AS RESEARCHERS MIGHT BE
DEFINING COMMUNITIES -- HOW
COMMUNITY THEMSELVES THINK.
AND JUST A QUICK EXAMPLE OF HOW
THIS MIGHT PLAY OUT.
THIS IS ONE OF THE SITES IN OUR
INSTITUTION.
WHAT YOU HAVE ON YOUR LEFT ARE
ALL KINDS OF STAKEHOLDERS AND
COMMUNITIES THAT WE MIGHT WANT
TO ENGAGE WITH.
THE CIRCLE IS DIFFERENT
TERMINOLOGIES THAT CAN BE USED
WHEN YOU'RE ENGAGING WITH THEM,
AND FINALLY, WE NEED TO
RECOGNIZE THAT MANY OF THESE
WOULD BE PLAYING DIFFERENT
ROLES.
AT ONE TIME WE ARE ENGAGING WITH
THE POLICY MAKERS, SO THAT THEY
CAN INFORM ON OUR RESEARCH, BUT
ON THE OTHER HAND -- AS WELL
COMMUNITY MEMBERS WITH SPECIFIC
INTERESTS, AND THOSE WILL PLAY
OUT IN THE SPACES OF ENGAGEMENT.
SO OFTEN WE TALK ABOUT
STAKEHOLDER ANALYSIS AND
COMMUNITY IS ONE OF THE STAKE
HOLD ARES AND FIGURING CAREFULLY
HOW YOU NEED -- SORRY --
STAKEHOLDER -- AND WHO ARE THE
COMMUNITIES AND STAKEHOLDERS YOU
NEED TO ENGAGE FOR YOUR RESEARCH
AND HOW THAT MIGHT PLAY OUT IN
THE COLLABORATIONS THAT YOU'RE
SETTING UP.
SO IF WE TAKE A MINUTE JUST FOR
OURSELVES, THIS IS NOT TO
RESPOND, JUST A QUICK REFRESHING
FOR A MINUTE, YOU CAN THINK
ABOUT YOURSELF AND WHERE YOU
SIT, HOW MANY COMMUNITIES ARE
YOU A PART OF?
IT COULD BE FROM -- IN A SOCIAL
GROUP TO WHATEVER ELSE YOU'RE
INVOLVED IN.
SOME OF THOSE MIGHT BE TIGHTLY
KNIT COMMUNITIES, OTHERS MIGHT
BE LOOSE GROUPINGS, FOR EACH OF
THOSE YOU CAN START THINKING HOW
WOULD OUTSIDERS IDENTIFY AND
ENGAGE WITH YOU?
AND THEN FOR EACH OF THOSE
COMMUNITIES, WHO CAN SPEAK ON
YOUR BEHALF?
AND IF YOU ARE THE ONE SPEAKING
ON BEHALF OF OTHERS, HOW DO YOU
COME TO BE SPEAKING ON BEHALF OF
OTHERS?
SO THE WAY WE ARE REFLECTING ON
THIS FOR OURSELVES IS VERY
SIMILAR WORK FOR MANY OF OUR
COMMUNITY MEMBERS WHO WOULD BE
REFLECTING HOW YOU'RE ENGAGING
WITH THEM.
HAVING SAID WHAT IS COMMUNITY
AND LEAVING YOU WITH ALL LAYERS
OF WHAT YOU WOULD DEFINE AS
COMMUNITY, THE NEXT LEVEL IS
THEREFORE WHAT IS ENGAGEMENT,
AND WHAT IS COMMUNITY
ENGAGEMENT, PUBLIC ENGAGEMENT ?L
NOW -- IN MY SLIDE.
WHAT YOU HAVE UNITED NATIONS SET
OUT --
>> OH, YES, YES, THAT'S WHAT WE
HAVE ON THE SLIDE.
>> SORRY?
>> WHAT WE HAVE ON THE SLIDE IS
"BUT WHAT IS COMMUNITY/PUBLIC
ENGAGEMENT" AND THE UNITED
NATIONS GUIDELINES.
>> YES.
SO THE UNITED NATIONS GUIDELINE
PROVIDE A VERY GOOD DESCRIPTION
ABOUT COMMUNITY ENGAGEMENT.
DESCRIBED AS A STRATEGIC PROCESS
IN -- INVOLVING LOCAL --
DECISION-MAKING AND
IMPLEMENTATION.
THEY FOCUS ON COMMUNITY
ENGAGEMENT, FEEL FREE TO LOOK AT
THOSE GUIDELINES BY UN.
AND NEXT -- AND THEN ALONGSIDE
THAT, YOU ALSO HAVE WHAT YOU
CALL PUBLIC ENGAGEMENT.
AND IN THE NEXT FEW SLIDES, I'LL
TRY TO TEASE OUT THIS.
BUT JUST RECOGNIZE THAT A LOT OF
TIMES, SOMETIMES COMMUNITY AND
PUBLIC ENGAGEMENT CAN BE USED
QUITE INTERCHANGEABLY.
BUT SOMETIMES THERE IS A
DIFFERENCE BETWEEN THE TWO.
AND THE PUBLIC ENGAGEMENT IS A
PROCESS THAT PROVIDES PEOPLE
WITH TRUSTWORTHY INFORMATION ON
KEY POLICY ISSUES, AND THAT IS
REALLY IMPORTANT BECAUSE I THINK
THERE'S A REAL FOCUS ON
INFORMATION-GIVING.
IF YOU HAVE SOME TIME YOU CAN
LOOK AT IT, IT DOES DEFINE WHAT
IS PUBLIC ENGAGEMENT.
NEXT.
SO WHEN WE THINK ABOUT
ENGAGEMENT, THERE ARE DIFFERENT
TYPES AND DEPTHS OF ENGAGEMENT
AND THIS COULD BE AT COMMUNITY
LEVEL AND AT PUBLIC LEVEL.
WHAT YOU SEE THERE ARE SOME OF
THE WAYS IN WHICH HEALTH
FACILITIES MIGHT BE PROVIDED
INFORMATION TO PATIENTS WHO ARE
COMING IN, INCLUDING WAITING
TIME CHARGES AND SO ON.
THAT'S A FORM OF PUBLIC
INFORMATION SHARING.
SO THERE ARE DIFFERENT
OPERATIVES THAT CAN BE USED.
INFORMATION SHARING, VERY LITTLE
INTERACTION BETWEEN -- YOU ALSO
HAVE ACTIVITY THAT ARE QUITE
INTERACTIVE WITH THE DIFFERENT
STAKEHOLDERS.
COMMUNITY-BASED PARTICIPATORY
APPROACH IS ONE THAT IS SHOWN OR
HAS BEEN DESCRIBED AS PROVI
PROVIDING -- IN TERMS OF
ENGAGEMENT.
THIS IS A BOOK THAT IS TALKING
ABOUT -- ACTION RESEARCH IN
HEALTH SYSTEMS, AND I KNOW THERE
ARE MANY TECHNOLOGIES THAT ARE
USED TO DESCRIBE -- RESEARCH,
DIFFERENT METHODOLOGIES, YOU
HAVE ALL THE ACRONYMS LISTED
DOWN THERE.
WHAT IS IMPORTANT IS THAT THE
COMMUNITY MEMBERS, HERE WE TALK
ABOUT THEM AS SUBJECTS OF
RESEARCH BECAUSE THAT'S HOW
THEY'RE DESCRIBED IN THE BOOK
BUT ACTUALLY THE COMMUNITY
MEMBERS ARE ACTIVE RESEARCHERS
AND ENGINES OF CHANGING THEIR
OWN COMMUNITIES.
AND SO YOU'RE THINKING ABOUT AN
ENGAGEMENT THAT IS MOVING
TOWARDS PARTNERSHIP RATHER THAN
SEEING RESEARCHERS AND
COMMUNITIES IN SEPARATE BODIES
BUT SEEING THEM AS COMING
TOGETHER OF INTEREST.
NEXT.
SO WE TALK ABOUT WHAT IS
ENGAGEMENT TALK ABOUT A SPECTRUM
OF ENGAGEMENT.
RANGING FROM WHAT WE CALL WIDEN
GAUGEMENT, AND WIDEN GAUGEMENT,
WIDE ENGAGEMENT,TRYING TO REACHE
AS POSSIBLE, YOU'RE LIKELY TO BE
LESS PARTICIPATORY, AND MIGHT BE
MORE DIRECTED.
IT MIGHT NOT NECESSARILY BE
SEEKING OPINIONS, YOU MIGHT JUST
WANT TO BE PASSING INFORMATION.
AND IT -- ISSUES LIKE PUTTING
ADVERTISEADVERTISEMENT IN NEWSP,
RADIOS, SOCIAL MEDIA, WHERE
YOU'RE NOT HAVING THAT
INTERACTION WOULD TEND TO BE
WIDE ENGAGEMENT.
THE OTHER EXTREME END IS WHAT
YOU CALL NARROW ENGAGEMENT.
THIS IS WHERE THERE'S MORE
DIRECTED PARTICIPATORY APPROACH
TO ENGAGEMENT, YOU'RE MEETING,
INTERACTING, SEEKING, YOU'RE
MAKING DECISIONS TOGETHER,
YOU'RE AGREEING ON ROLES AND
RESPONSIBILITIES AND SO WHOEVER
YOU'RE ENGAGING BECOMES PART OF
THE TEAM, AND EVEN WITHIN THERE,
YOU HAVE A WHOLE RANGE OF
SPECTRUM.
THE REASON WHY I'M PUTTING THIS
IS JUST TO SAY THE DIFFERENT
WAYS IN WHICH ENGAGEMENT CAN BE
DONE.
THERE'S NO PERFECT ONE, IT VERY
MUCH DEPENDS ON YOUR GOALS, WHY
YOU'RE ENGAGING, AND WHAT YOU
WANT TO ACHIEVE FROM THOSE
GOALS.
AND THAT IS REALLY IMPORTANT IN
DETERMINING WHETHER YOU WANT TO
REACH AS MANY PEOPLE OR YOU WANT
TO BE MORE NARROWED AND FOCUSED.
ALWAYS REMINDED OF THIS LADDER
OF PARTICIPATION IN MANY -- THAT
SHOWS THE DIFFERENT LAYERS OF
POWER SHARING.
THIS IS NOT A SOCIAL PROJECT BUT
IS VERY APPLICABLE TO HEALTH
RESEARCH.
AND TO THINK WHAT IT DOES AND
FOR US DRAWS ATTENTION TO IS THE
CAUTION THAT OUR ENGAGEMENT
SHOULD NOT BE -- IT SHOULD NOT
BE AIMED AT PUTTING PEOPLE ON
THE TABLE BUT NOT REALLY
LISTENING TO THEM FOR THE SAKE
OF WHICH THAT WE ARE ENGAGING,
BUT RATHER TO START BUILDING
TOWARDS HIGHER LEVELS OF
ENGAGEMENT WHERE PEOPLE OR
COMMUNITIES ARE PARTNER AND PART
OF OUR RESEARCH PROJECT.
AND OFTEN FOR EXAMPLE IN OUR
RESEARCH PROGRAM, WE HAVE A
WHOLE RANGE OF ACTIVITIES WITH
DIFFERENT STAKEHOLDERS.
AGAIN BASED ON STAKEHOLDER
ANALYSIS, FORMATIVE RESEARCH
VERY EARLY ON, DIFFERENT GROUPS
WILL REQUIRE DIFFERENT APPROA
APPROACHES AND THINK CAREFULLY
WHAT APPROACH WILL BE
APPROPRIATE, SOME OF THEM TO ASK
FOR EXAMPLE WE HAVE -- SCHOOL
ENGAGEMENT, A PROGRAM THAT CAME
AS A RESULT OF COMMUNITIES
ASKING US TO ENGAGE SCHOOLS IN
BOTH SCIENCE AND HEALTH
RESEARCH.
WE HAVE MINISTER OF HEALTH
STAKEHOLDER ENGAGEMENT ACROSS
ALL THE LEVELS OF HEALTHCARE
FROM LOCAL LEVEL TO THE
INTERNATIONAL LEVEL.
AND THIS IS IN ADDITION TO
VARIOUS OTHER WAYS IN WIRE WE'RE
ENGAGING COMMUNITIES, COMMUNITY
LEADERS, TO PARTICIPATE IN
RESEARCH, AND THOSE WHO WE CALL
HARD TO REACH, ENGAGING WITH OUR
STAFF USING DIFFERENT FORUM.
SO IF WE LOOK AT ALL THESE ABOUT
BUILDING RELATIONSHIPS AND EVEN
PARTNERSHIPS, BUT AS MUCH AS
WE'RE -- IT'S STILL VERY HARD TO
REACH EQUITY AND THAT IS ONE OF
THE THINGS WE CONTINUOUSLY
CONTINUE WORKING ON.
SO HAVING TALKED ABOUT COMMUN
COMMUNITY, WHO IN THE COMMUNITY
ARE WE ENGAGING?
A QUICK ONE IN OUR CENTER, OUR
POPULATION IS 300,000 PEOPLE,
THAT'S JUST A POPULATION THAT
ARE PARTICIPATING, THAT OFTEN
WOULD BE INVOLVED IN ONE WAY OR
THE OTHER TO RESEARCH, THE
POPULATION WHERE WE ARE
RECRUITING OUR RESEARCH
PARTICIPANTS FROM.
300,000 PEOPLE, WHERE DID WE
START FROM IF WE WANT TO ENGAGE
WITH THEM?
OBVIOUSLY THE ISSUE OF
REPRESENTATION COMES IN, AND
THERE ARE DIFFERENT FORMS OF
REPRESENTATION.
PRESENTATION IN TERMS OF THEY
SPEAK ON BEHALF OF PARTICULAR
COMMUNITIES, THE FACT THAT THEY
WERE ELECTED BY THE COMMUNITIES
TO REPRESENT THEM FOR EXAMPLE IN
GOVERNMENTS OR IN SOCIAL GROUPS,
REPRESENTATION, YOU NEED TO LOOK
AT PARTICULAR GROUPS THAT ARE
OFTEN NOT HARD, OR THAT ARE HARD
TO REACH, BUT MORE IMPORTANTLY,
IT'S WHO DECIDES ABOUT THE
REPRESENTATION, IS IT THE
RESEARCHERS, IS IT THE
COMMUNITIES, HOW DO WE WORK --
THE RESEARCHER MIGHT WANT TO
VERY QUICKLY SEEK OPINIONS AND
MOVE ON.
THE COMMUNITY MIGHT NOT SEE THE
PEOPLE THAT RESEARCHERS ARE
ENGAGING WITH IS THEIR
REPRESENTATIONS.
SO IN OUR STRATEGY, THEREFORE,
WE ALWAYS NEED TO THINK ABOUT
REPRESENTATION WHO THEY ARE
REPRESENTING AND WHY THEY ARE
REPRESENTING.
SO CONSIDER SEVERAL THINGS, ONE
IS ENSURING DIFFERENT VOICES ARE
HARD, ARE INVOLVED, ARE LISTENED
TO, ARE PART OF THE ENGAGEMENT.
CLARITY ABOUT ROLES AND
RESPONSIBILITY BECAME VERY
IMPORTANT FOR US AND DOCUMENTED
IN SOME OF OUR -- ALSO THE
IMPORTANCE OF BALANCING
MOTIVATIONS FOR PARTICIPATION
AND ENGAGEMENT VERSUS WHAT IS
FAIR -- AND INDEPENDENCE.
IN OUR WORK, WHAT BECAME VERY
CLEAR IN THAT PUTTING THEMSELVES
EARLY ON FOR REPRESENTATION, WE
WERE VERY INTERESTED IN MAKING
SURE THAT THEIR CHILDREN GET
OPPORTUNITIES TO WORK IN THE
RESEARCH INSTITUTION OR TO HAVE
FIRST PRIORITY WHEN IT COMES TO
RESEARCH BECAUSE AGAIN WE ARE
WORKING IN SITUATIONS WHERE
HEALTHCARE SYSTEMS MIGHT NOT BE
WORKING VERY WELL.
THE WELLCOME TRUST WAS SEEN AS A
GREAT EMPLOYER.
THE MOTIVATION THAT MIGHT PLAY
OUT IN OUR ENGAGEMENT ACTIVI
ACTIVITIES, HOW THEN WE ADDRESS
THOSE BECOME VERY INTERESTING.
WE INTENTIONALLY DECIDED TO GET
MULTIPLE COMMUNITY MEMBERS, ONE
IS A WAY OF MAKING SURE AS MUCH
AS POSSIBLE WE ARE REACHING AS
MANY COMMUNITY MEMBERS AS
POSSIBLE, AND EXPECTATION AND
WHAT IS EXPECTED OF THOSE WHO
JOIN THE COMMUNITY ADVISORY
BOARD.
AND OF COURSE THERE'S THE ISSUE
OF CHALLENGES OF INFORMATION, OF
THE KIND OF INFORMATION THAT WE
ARE PROVIDING, AND STAFF MIGHT
SEE THEMSELVES AT A DIFFERENT
LEVEL FROM THE COMMUNITY, SO HOW
DO WE BREAK THE BARRIERS.
SO THESE ARE SOME OF THE
CHALLENGES THAT YOU MIGHT BE
FACING, BUT IN YOUR
REPRESENTATION, WE HAVE TO
CONSIDER THAT.
WHAT FOR US IS IMPORTANT IS
BUILDING WHAT WE SAY, TRUSTING
RELATIONSHIP, OR TRUSTFUL
RELATIONSHIPS OVER TIME, AND
THAT TRUST MUST BE WE WELL-FOUN.
WELL-FOUNDED JUST MEANS THAT IT
CAN CHALLENGE US AND THEY CAN
TELL US WHEN THEY ARE NOT HAPPY
WITH THINGS.
IN FACT, MISTRUST IS GOING TO
BUILD UP BUT WE NEED TO BE
CAREFUL THAT THE MISTRUST -- WE
SHOULD BE COMFORTABLE WITH THAT.
SO WE'VE SEEN ALL THESE ABOUT
COMMUNITIES AND REPRESENTATIONS
AND DEPTH OF ENGAGEMENT.
OBVIOUSLY A BIG QUESTION IS CAN
YOU SCALE UP WHEN YOU'VE GOT --
WHEN YOU FOCUS, ARE YOU ABLE TO
SCALE UP.
AND THE PIECE OF WORK YOU'RE
DOING WITH ENGAGEMENT -- THAT IS
ALWAYS OUR QUESTION.
SO THERE ARE SOME CHALLENGES
WITH ENGAGEMENT.
AND SOME OF THESE CHALLENGES ARE
BECAUSE THERE COULD BE COMPETING
GOALS WHEN YOU'RE THINKING ABOUT
ENGAGEMENT.
IMPROVING HEALTH, HAVING
SUCCESSFUL RESEARCH COULD BE
COMPETITION.
DEFINITION OF RELATIONSHIPS THAT
YOU TRY TO BUILD.
THE PERMISSION OF COMMUNITY
COULD BE INTENTION, WE NEED TO
YOU COMPROMISE THAT.
SOMETIMES WE MIGHT WANT TO DO
ENGAGEMENT BECAUSE IT'S A
REQUIREMENT BY ETHICS -- BY
FUNDERS, HOW DOES THAT PLAY UP
WITH THIS.
ALWAYS RECOGNIZING THE INTRINSIC
VALUE OF ENGAGEMENT AND IT'S
IMPORTANT TO IDENTIFY AREAS THAT
NEED -- ABOUT ENGAGEMENT.
THE CONTEXT IS A VERY IMPORTANT
PART IN THINKING ABOUT
ENGAGEMENT, WHAT IT IS ABOUT
HEALTH SYSTEMS OR ABOUT HEALTH
RESEARCH.
OUR ENGAGEMENT, WE NEED TO
CONSIDER CAREFULLY HOW IS
COMMUNITY INPUT INFORMING
WHATEVER WORK, INCLUDING THE
CORE GOALS OF THE RESEARCH, AND
THE CORE ACTIVITIES OF THE
RESEARCH INSTITUTION.
-- IN PLACE AND THEY LISTENED
TO OR RESPECTED, HOW ARE WE
MAKING SURE THAT ENGAGEMENT IS
GENUINE?
NOT JUST ABOUT US AND OUR WORK,
BUT THAT WE ARE ALSO RESPONDING
TO COMMUNITY PRIORITIES.
AND COMMUNITY NEEDS AND
EXPECTATIONS.
HOW DO WE DEAL WITH EXPECTATIONS
OF THE COMMUNITIES.
WITHIN COMMUNITIES, IT'S
IMPORTANT TO RECOGNIZE THE
RIGHTS AND AWARENESS OF THEIR
RIGHTS AS PART OF ENGAGEMENT.
REPRESENTATION AND HEALTH
OUTCOMES TO BE.
AND WHOSE VOICE IS INCLUDED,
WHOSE VOICE IS EXCLUDED, AND HOW
BEST DO WE REACH OUT TO THOSE
WHOSE VOICES ARE EXCLUDED AS
SILENT AND NOT EVEN IN THE
MARGIN OF COMMUNITY -- WHERE
COMMUNITY VIEWS ARE AIRED, HOW
DO WE REACH OUT TO WHAT I CALL
HARD TO REACH POPULATIONS.
THIS COULD BE GEOGRAPHICALLY, IT
COULD ALSO BE SOCIOECONOMIC, IT
COULD BE ALL KINDS OF THINGS
THAT COULD PLAY OUT.
IT COULD ALSO BE ABOUT FREEDOMS
AND WHETHER PEOPLE FEEL FREE TO
RAISE AND FEEL THAT THEIR
OPINIONS AND VOICES ARE
RESPECTED.
WE ALSO RECOGNIZE THAT
ENGAGEMENT ALSO HAPPENS WITHIN
WIDER SOCIAL POLITICAL
ENVIRONMENTS, DEMOCRATIC FOR
PEOPLE TO VOICE THEIR OPINIONS,
HOW WE MAKE USE OF THOSE FORA.
THEY THERE ARE ISSUES ABOUT
HUMAN RIGHTS AND INFORMATION
AVAILABILITY, AND HOW DO WE MAKE
SURE THAT OUR ENGAGEMENT --.
THERE ARE OF COURSE LIMITS OF
ENGAGEMENT.
AND THE ONE OF THOSE IS THAT IT
CAN CONTRIBUTE TO DISCUSSIONS
ABOUT KEY AREAS OF IMPORTANCE.
FOR EXAMPLE, ON ISSUES AROUND
WHAT IS APPROPRIATE BENEFIT
SHARING ABOUT CARE -- THEY MAY
NOT SOLVE ALL THAT BUT CAN
CONTRIBUTE TO THE DISCUSSIONS
ABOUT THAT.
IT MIGHT ALSO CONTRIBUTE TO
ISSUES ABOUT HISTORICAL
INJUSTICES, BACKGROUND
INEQUITIES AND SO ON, BUT BY
ITSELF IT CANNOT PERHAPS SOLVE
IT, IT CAN PROVIDE A FORUM IN
WHICH THIS IS DISCUSSED BY
ITSELF MIGHT NOT BE IN A
POSITION TO SOLVE ALL THESE
ISSUES.
SO IT'S ALWAYS GOOD TO HAVE
UNDERSTANDINGS OF WHAT IS IT
THAT WE KNOW ENGAGEMENT CAN DO
AND WHAT ARE THE LIMITS OF WHAT
ENGAGEMENT CAN D DO .
NEXT.
I THINK PERHAPS A POINT TO
REFLECT FOR ALL OF US, IS IT ALL
RELEVANT, AND IN OUR WORK, WE
CAN HAVE A REA FLEXION OF WHAT
ARE THE GOALS OF WHAT WE ARE
TRYING TO DO WITH ENGAGEMENT.
WHO DECIDES OF THE GOALS?
AND WHO DECIDES ON THE RANGE AND
DEPTH OF ENGAGEMENT?
IS IT COMMUNITIES?
IS IT RESEARCHERS?
IS IT CO-CREATING AND IF IT'S
CO-CREATING, WHAT FORUMS HAVE
BEEN USED TO CO-CREATE THESE?
HOW ARE THE DIFFERENT VOICES
REPRESENTED IN THESE FORA?
THEN THE NEXT THING IS WHEN YOU
THINK ABOUT COMMUNITIES, AND
FROM THE FIRST SLIDE, WHO ARE
THE COMMUNITIES WE ARE THINKING
OF?
HOW MIGHT THEY BE REPRESENTED?
HOW ARE THE REPRESENTATIVES
SELECTED, BY WHOM?
HOW DOES THAT SELECTION OF
REPRESENTATION INFLUENCE THE
NATURE OF ENGAGEMENT?
WHOSE VOICES ARE LISTENED TO,
AND WHOSE VOICES HAVE NOT BEEN
LISTENED TO, WHOSE VIEWS MATTER
AND WHOSE ARE NOT BEING LISTENED
TO?
IT'S IMPORTANT TO BE AWARE OF
THAT.
THEN WHAT TYPES OF INTERACTIONS
AND ENGAGEMENT ARE IMPORTANT?
WHAT ARE SOME OF THE POTENTIAL
CHALLENGES WITH THOSE?
WHAT ARE THE -- IN WHICH WE
IDENTIFY ISSUES AND RESPONDING
TO THEM?
ARE ISSUES BEING ACTED UPON, AND
IF THEY HAVE NOT BEEN ACTED
UPON, HOW IS FEEDBACK PROVIDED?
WE JUST KEEP SILENT AND MOVE ON
WITH OUR RESEARCH?
WHICH I KNOW HAPPENS.
AND THEN HOW DO WE ADDRESS
EXPECTATIONS?
AND HOW DO WE DEAL WITH OUR
FEELINGS OF RESPONSIBILITY,
WHICH WE CANNOT ADDRESS BECAUSE
EITHER IT IS BEYOND OUR LIMITS,
OUR -- OR WE ARE NOT IN A
POSITION TO, WE DO NOT HAVE
EXPERTISE TO RESPOND, SO HOW DO
WE DEAL WITH THAT?
NEXT.
SO THAT IS ON ENGAGEMENT.
OBVIOUSLY IT'S ONE WAY TO
IMPLEMENT, BUT IT'S ALSO
IMPORTANT TO LEARN FROM WHAT WE
ARE DOING IN ENGAGEMENT AND
EVALUATION IS ONE IN WHICH WE DO
THIS, THERE'S A WHOLE SESSION ON
EVALUATION, I'LL NOT TALK ABOUT
IT, BUT JUST TO MAKE SURE THAT
WE DO NOT FORGET IT IT'S IMPORTT
FOR US TO LEARN FROM WHAT WE ARE
DOING, AND WHAT YOU SEE THERE IS
A CALL TO INVEST IN EVALUATING
ENGAGEMENT SO THAT IT IS NOT
SIMPLY A MATTER OF TRIAL AND
ERROR, BUT THAT WE ARE ALSO
LEARNING FROM IT AND KNOWING
WHAT ARE THE BEST PRACTICES ON
HOW THIS COULD BE SCALED UP IF
THEY CAN BE.
THIS IS SUPPOSED TO BE A VIDEO,
I DON'T KNOW IF IT WILL PLAY.
IT WILL NOT PLAY?
OKAY.
SO THIS IS A VIDEO WITH A LINK
IN WHICH WE DISCUSS SOME OF
THE -- OF ENGAGEMENT OF WORK
WE'VE BEEN DOING AND SOME OF THE
KEY FINDINGS.
THERE'S A LINK THAT'S PROVIDED
AND WHAT WE DRAW ATTENTION TO IS
IMPORTANCE OF ENGAGEMENT IF NOT
CAREFULLY DONE, IT CAN
PERPETUATE THE PARADIGM OF POWER
IMBALANCES AND INEQUITIES
BETWEEN RESEARCHERS AND
COMMUNITIES, BETWEEN GLOBAL
NORTH AND GLOBAL SOUTH, AND I
USE THOSE TERMS VERY LOOSELY.
>> WE'LL POST THAT FOR EVERYONE
TO HAVE ACCESS TO, DORCAS.
>> OKAY, THANK YOU.
SO JUST AS OUR WAY OF
SUMMARIZING, SO WE DISCUSSED
ABOUT SOME OF THE INSTRUMENTAL
AND INTRINSIC GOALS OF
ENGAGEMENT, AND THE IMPORTANCE
OF ENGAGEMENT HAS BEEN ONE
APPROACH TO SUPPORTING IT
THROUGH PRACTICE AND RESEARCH,
THERE ARE OF COURSE SOME
UNINTENDED CONSEQUENCES AND THIS
COULD BE NEGATIVE AND POSITIVE.
THERE ARE IMPLICATIONS FOR
RELATIONSHIPS, FOR TIME AND
RESOURCES, FOR OPPORTUNITY
CALLS, AND EXPECTATIONS.
WE SHOULD CAREFULLY CONSIDER AND
TRACK SOME OF THE ELEMENTS
INCLUDING THE GOALS OF
ENGAGEMENT, BECAUSE THEY ARE
ALWAYS CHANGING.
AND IT IS OKAY FOR THEM TO
CHANGE.
THE DEPTH OF ENGAGEMENT, WHO
DECIDES.
IS ENGAGEMENT RESEARCH-DRIVEN OR
IS IT COMMUNITY-DRIVEN OR IS IT
A PARTNERSHIP?
AND I'M SAYING THIS NOT
BECAUSE -- BUT TO BE AWARE OF
THEM.
WHO ARE THE COMMUNITIES THAT WE
ARE ENGAGING?
WHO ARE THE REPRESENTATIVES OF F
THOSE COMMUNITIES AND WHAT --
WHO SELECTS THEM, WHO IS
INVOLVED, THAT'S REALLY
IMPORTANT TO SEEK OUT WHOSE
VOICES IN COMMUNITIES THAT HAVE
NOT BEEN REACHED TO.
AND THEN, OF COURSE, TO CONSIDER
THE TYPES AND RANGE OF
ENGAGEMENT THAT WOULD WORK FOR
DIFFERENT COMMUNITIES.
AND THIS WOULD CHANGE OVER TIME.
AND DEPENDING ON COMMUNITIES AND
ISSUES.
AND MECHANISMS TO IDENTIFY AND
RESPOND TO EMERGING ISSUES, AND
ALSO RECOGNIZE THE LIMITS TO
ENGAGEMENT.
THAT IS ISSUES THAT COMMUNITY
ENGAGEMENT MIGHT NOT BE ABLE TO
ACHIEVE.
I THINK THAT'S WHAT I -- NOT
BEING ABLE TO PLAY THE VIDEOS,
BUT I HOPE YOU HAVE THE TIME TO
PLAY THE VIDEO.
NEXT, I THINK THAT'S THE LAST
SLIDE.
THIS IS A CASE STUDY, SOMETHING
FOR PEOPLE TO READ.
PLEASE DO FEEL FREE TO READ THAT
TO JUST GET A SENSE OF HOW WE'RE
GOING TO A TOTALLY NEW AREA, HOW
COMMUNITY ENGAGEMENT CAN EITHER
INITIALLY BE SO CHALLENGING BUT
OVER TIME, YOU INTERACT WITH
COMMUNITIES, YOU CAN IMPACT SO
MANY THINGS THAT CAN HELP YOU BE
INTEGRATED WITHIN THE COMMUNITY
OR TO COMPLETELY BE NOT SO WELL
ALIGNED TO THE COMMUNITY.
SO IT WAS AN INTERESTING CASE
FOR US EVEN THOUGH WE HAD BEEN
IN OUR PROGRAM FOR QUITE SOME
TIME, THOUGHT WE KNEW WHAT TO
DO.
BUT WE THOUGHT WE HAD DONE
EVERYTHING THAT NEEDED TO BE
DONE, AND THEN REALIZE
COMMUNITIES -- YOU CANNOT JUST
BORROW EXAMPLE FROM ONE
COMMUNITY AND THINK IT WILL WORK
WELL IN ANOTHER COMMUNITY, AND
THAT WAS A NICE -- IT WAS A
TOUGH BUT A NICE WAY FOR US TO
LEARN.
THANK YOU.
>> I'LL POST THAT AS WELL,
DORCAS.
THANK YOU SO MUCH.
[APPLAUSE]
SO WE HAVE SOME TIME FOR
QUESTIONS.
JUST TO ORIENT YOU, DORCAS, WE
HAVE ABOUT SIX OR SO FOLKS IN
THE ROOM TODAY.
THEY CAN GO TO THE MICS TO ASK
QUESTIONS, AND I ALSO HAVE
QUESTION FROM THOSE WHO ARE
ATTENDING FROM A DISTANCE.
BUT CAROLINE HAS A QUESTION.
SHE'S HEADED TOWARDS THE MIC.
>> OKAY.
>> HELLO.
THANK YOU SO MUCH FOR THIS
PRESENTATION.
IT WAS SUPER INFORMATIVE.
I JUST WANTED TO ASK, BECAUSE
THROUGHOUT YOUR PRESENTATION, I
WAS STRUCK BY KIND OF THE
INADEQUACY OF THE WORDS
COMMUNITY ENGAGEMENT TO DESCRIBE
THE LIKE MANY VARYING THINGS
THAT IT CAN ENTAIL AND SOMETIMES
MAYBE EVEN THE HARM THAT WE CAN
INFLICT BY NOT SPECIFYING WHAT
COMMUNITY ENGAGEMENT MEANS.
AND SO I'M WONDERING IF YOU
COULD TALK A LITTLE BIT ABOUT, I
DON'T KNOW, KIND OF THE GAP
BETWEEN WHAT PEOPLE USUALLY MEAN
WHEN THEY THROW OUT THE WORD
COMMUNITY ENGAGEMENT AND WHAT IT
REALLY ENTAILS AND HOW WE SHOULD
50 ABOUT SPECIGO ABOUT SPECIFYIH
HAVE A BUTTER OR MORE SPECIFIC
WAYS OF DESCRIBING IT, THE
DIFFERENT FORMS THAT IT COULD
TAKE.
>> THAT'S REALLY A GREAT
QUESTION, AND I THINK A LOT OF
PEOPLE ASK ME THAT ESPECIALLY
AFTER THIS PRESENTATION, ONE OF
THE VIDEO CLIPS HAS GOT A
WEBSITE THAT PROVIDES MATERIALS
FOR WHAT IS ENGAGEMENT, WHAT ARE
THE WAYS IN WHICH YOU CAN
ENGAGE.
WHAT MY QUICK ADVICE IS THAT THE
TERMS USED SO MANY DIFFERENT W
WAYS TO DESCRIBE SO MANY
DIFFERENT THINGS, AND ANY TIME I
HEAR SOMEONE SAYING I'M ENGAGING
COMMUNITIES, THE FIRST THING IS
WHAT EXACTLY ARE YOU DOING?
I THINK THAT IS ALWAYS A
STARTING POINT.
JUST TO TELL PEOPLE TO DESCRIBE
ARE YOU PROVIDING INFORMATION OR
MATERIALS, ARE YOU DOING AN --
FORUM IN COMMUNITIES, ARE YOU
HOLDING MEETINGS WITH THEM, ARE
THEY INVOLVED IN YOUR RESEARCH.
JUST EVEN TRY TO TELL PEOPLE,
DON'T JUST USE THE WORD, BECAUSE
IT ENCOMPASSES SO MANY THINGS.
IF YOU JUST USE IT WITHOUT
QUALIFYING IT.
I THINK THAT IS ONE WAY IN WHICH
YOU CAN GET A SENSE OF WHAT IS
HAPPENING.
THE OTHER THING WHEN I HEAR
PEOPLE SAY COMMUNITY IS I GET TO
ASK THEM, WHO IS YOUR COMMUNITY?
AND IT'S BECOME KIND OF A KNEE
JERK REACTION THAT EVERY TIME
SOMEONE SAYS I'M ENGAGING, I SAY
WHO IS YOUR COMMUNITY, WHAT ARE
YOU DOING WITH THEM, BECAUSE
WHEN I GET A SENSE OF WHAT IT
IS, IS THERE AN EASIER WAY OF
DEFINING IT?
I THINK SOME OF THE SCHOLARS --
THAT'S WHY WE COME WITH LAYERS
OF ENGAGEMENT RATHER THAN SAYING
ONE WORD, SO THAT'S WHY WE HELD
INFORMATION -- CONSULTATIONS, SO
ON, SO YOU HEAR THESE LAYERS OF
ENGAGEMENT INVOLVEMENT, PEOPLE
TALK ABOUT QUESTIONS, WHO ARE
ALSO RESEARCHERS BEEN INVOLVEDED
IN THE ACTIVITY.
SO YOU HAVE THESE NAMES THAT ARE
OFTEN USED, BUT AGAIN I WOULD
SAY IF SOMEONE COULD JUST SAY
WHAT IT IS THAT THEY ARE DOING,
THAT IS HELPFUL.
I DON'T THINK I ANSWERED YOU, I
JUST -- THE COMPLEXITY OF IT.
>> I THINK YOU DID ANSWER
CAROLINE, DORCAS, AND I GUESS I
MIGHT SAY SOMETHING LIKE, THERE
IS A WORRY, I DON'T KNOW EXACTLY
FROM WHERE CAROLINE'S QUESTION
CAME FROM, BUT THERE IS A WORRY
THAT PEOPLE JUST SAY, AS YOU
JUST DESCRIBED, OH, I AM
ENGAGING THE COMMUNITY.
AND UNLESS WE ASK THEM, AS YOU
DESCRIBED, WHAT THEY'RE ACTUALLY
DOING, THEY'RE OFTEN USING IT IN
A SHORTHAND WAY, OR THEY KNOW
THEY SHOULD SAY SOMETHING ABOUT
THAT, SO I THINK, YOU KNOW,
MAYBE IT'S DIFFERENT
TERMINOLOGY, BUT I LIKE HOW YOU
FRAMED IT OF, YOU KNOW, IT'S
PERHAPS OUR RESPONSIBILITY TO --
RESPONSIBILITY IS HARD, BUT WHEN
WE'RE CURIOUS, RIGHT, SAY, WELL,
TELL ME WHAT YOU'RE DOING.
OR TELL ME WHAT COMMUNITY MEANS
TO YOU, WHEN YOU SAY YOU'RE
ENGAGED WITH COMMUNITY, WHO IS
THAT THAT YOU'RE ENGAGED WITH?
AND THERE CAN BE A CONVERSATION.
BUT I ALSO THINK PRESENTATIONS
LIKE YOURS ARE A WAY TO MOVE
THIS BAR FORWARD TOO OF, YOU
KNOW, MAKING PEOPLE APPRECIATE
HOW THE SORT OF WHAT YOU IMAGINE
COMMUNITY ENGAGEMENT IS OF, OH,
YEAH, I'M GOING TO TALK WITH
SOME PEOPLE WHO ARE ENROLLED IN
THE STUDY, OR, YOU KNOW, THAT'S
NOT ENOUGH.
THAT THERE ARE GOALS AND
OBJECTIVES AND DEPENDING ON YOUR
GOALS AND OBJECTIVES, THE
COMMUNITY ENGAGEMENT THAT YOU
ARE ENGAGED IN CAN BE VERY
DIFFERENT.
SO MAYBE SOME DAY WE'LL HAVE
SOME BETTER LANGUAGE, BUT I LIKE
THE WAY YOU PHRASED ASKING THOSE
SPECIFIC QUESTIONS.
KELLY HAS A QUESTION.
>> HI.
THANK YOU FOR YOUR TALK.
I WAS WONDERING, JUST PACED ON
BASED ONYOUR TALK AND THE OTHER,
IT SEEMS LIKE THERE ARE A LOT OF
SAFEGUARDS OR PEOPLE SAYING
RESEARCHERS AND FUNDERS SHOULD
THINK ABOUT IN ORDER TO PROTECT
COMMUNITIES THAT MIGHT ENGAGE IN
HARM OR TO RECEIVE THAT THEY
RECEIVE A BENEFIT.
WHAT I WAS WONDERING IS THAT TO
ME, IT ALMOST SEEMS LIKE MAYBE
THIS FRAMING IS BACKWARDS, THAT
IT'S KIND OF LIKE HOW CAN WE
ENSURE THAT WE'RE DOING RESEARCH
AND, YOU KNOW, HOPEFULLY IN A
WAY THAT IS ALSO GOING TO HELP
PEOPLE, BUT IT SEEMS LIKE MAYBE
THE BETTER WAY TO AVOID SOME OF
THESE LIKE PITFALLS OF SORT OF
LIKE NOT DOING COMMUNITY
ENGAGEMENT THE RIGHT WAY OR LIKE
NOT ENSURING THAT THESE
COMMUNITIES ARE KIND OF GETTING
WHAT WOULD BE IN THEIR BEST
INTERESTS WOULD BE TO SAY THAT
PLAMAYBE THE PRIORITY SHOULD BE
WHAT CAN WE DO TO BENEFIT THESE
COMMUNITIES AND IF THAT IS
RESEARCH, HOW DO WE CARRY IT
OUT.
SO I GUESS I WAS WONDERING, WHAT
WOULD YOU SAY TO THAT KIND OF
TENSION OF THESE COMPETING
PRIORITIES OF REALLY DOING
RESEARCH AS A FORM OF SOLIDARITY
OR AID VERSUS PRIORITIZING THE
RESEARCH ITSELF AND TRYING TO
REDUCE HARM OR MAXIMIZE BENEFIT
TO THE EXTENT POSSIBLE?
>> THAT'S A LOT OF QUESTION, I
HOPE I GOT IT.
WHAT I'M HEARING IS, I THINK YOU
TRY TO POINT OUT SOME TENSION
THAT COULD ARISE BETWEEN WHEN WE
ENGAGE A COMMUNITY, WHERE THEIR
PRIORITIES FIT IN BOXES, WHAT
DEFINED RESEARCH PRIORITIES
COULD BE AND WHAT ARE SOME OF
THE AREAS THAT COULD THINK WE
MIGHT BY ALL GOOD INTENTIONS BE
ADDRESSING THEM BUT PERHAPS
COMMUNITIES MIGHT NOT BE SEEN
THAT WAY, AND DO CORRECT ME IF I
GOT IT WRONG, AND ABOUT
APPROPRIATE BENEFIT AND REDUCING
HARM AND RISKS IN RESEARCH.
I DON'T THINK I HAVE A RIGHT
ANSWER FOR THEM, TO ALL THOSE
QUESTIONS.
MY QUICK TAKE ON THESE IS, I
THINK IN THIS ERA AND TIME,
RESEARCH WITH COMMUNITIES,
RESEARCH THAT INVOLVES PEOPLE
AND THEIR -- SO I'M TALKING FROM
A POINT WHERE I KNOW I ADVOCATE
FOR COMMUNITY ENGAGEMENT, I
THINK RESEARCH THAT INVOLVES
PEOPLE IS LIKELY AND I'M NOT
SURE THAT THIS IS SCIENTIFICALLY
PROVEN, BUT IT LIKELY BY ALL
INTENTS AND PURPOSE TO BE BETTER
FOR THAT COMMUNITY TO BE
INVOLVED AND BE INVOLVED VERY
EARLY ON INCLUDING THINKING
WHETHER A PIECE IS A PRIORITY IN
THAT POPULATION.
AND OF COURSE AS A RESEARCHER,
YOU'D BE GOING AND HAVING LOOKED
AT WHETHER RESEARCH -- AND THAT
IS OKAY BECAUSE THAT IS OUR ROLE
AS A RESEARCH.
BUT PERHAPS OVER AND ABOVE WHAT
WE'RE ASKING IS IN ADDITION ALSO
SEEK COMMUNITY VIEWS AND THEY
MIGHT NOT TELL YOU YOUR SPECIFIC
RESEARCH QUESTION BUT THEY CAN
TELL YOU WHERE THE NEED IS AND
THEN IT'S UP TO YOU TO THINK
WHETHER YOU CAN ADDRESS THAT OR
YOU CAN DEFINE THE RESEARCH
QUESTION.
SO THAT'S ONE ASPECT TO IT.
RECOGNIZE ALL RESEARCH, AND AS
MUCH AS -- FOR ENGAGEMENT, NOT
ALL RESEARCH CAN NECESSARILY
HAVE ELEMENTS OF ENGAGEMENT.
AND WE'VE REALLY TRIED, AND EVEN
MY OWN RESEARCH HAD COME BACK
AND SAY I REALLY TRIED, BUT IS
THIS A KIND OF RESEARCH
QUESTION, THAT MEANS TO INVOLVE
COMMUNITY ENGAGEMENT.
SOME OF THE REALLY BASIC -- AND
NOT OWL, S ALL, SOME COULD BE SE
UK, THBASIC,THERE'S NO -- YOU'RO
DECIDE SHOULD I GET COMMUNITIES
AND SOME OF IT COULD BE YES
LET'S ENGAGE TO LET THEM N KNOW
WHAT I'M DOING, BUT IT MIGHT NOT
HAVE ANYTHING ELSE APART FROM
CREATING AWARENESS OF WHAT
YOU'RE DOING.
THE EXTENT TO WHICH I THINK
ENGAGEMENT CAN INFORM ON
APPROPRIATE BENEFITS OF RISK,
HARM REDUCTION, I THINK WE'VE
DONE SOME WORK, WE HAD TO USE A
VERY PARTICULAR METHODOLOGY
BECAUSE OF AGAIN THESE AREAS
MIGHT SOUND VERY CLEAR TO US.
BUT DISCUSSING WHAT IS OUR RISK
AND HOW RISK DIFFER FROM HARM TO
THE COMMUNITY.
IN A WAY THAT CAN MEANINGFULLY
INFORM YOU, DOES REQUIRE SOME
KIND OF EXPERTISE, AND WAVE DONE
THAT IN OUR CONTEXT, BECAUSE WE
KIND OF BUILD -- TO BE ABLE TO
DO THAT.
SO I THINK IT'S A GOOD THING.
BUT I ALSO RECOGNIZE THAT NOT
EVERYBODY MIGHT HAVE THE -- TO
DO THAT AND YOU MIGHT NEED TO
THINK VERY CAREFULLY AGAIN WHAT
IS YOUR GOAL OF ENGAGEMENT AND
WHAT DO YOU WANT TO GET OUT OF
IT, AND IT'S ONE THING TO SAY
IT'S A NICE THING TO DO, IT'S
ANOTHER THING TO SAY IT'S -- TO
DO.
SO I'M JUST PUTTING IT OUT THERE
TO SAY THESE ARE SOME OF THE
THINGS YOU MIGHT NEED TO THINK
ABOUT.
I AM NOT SURE ON ONE SIDE OF
YOUR QUESTION -- ENGAGEMENT IS
GOOD BUT NOT IN ALL
CIRCUMSTANCES AND YOU NEED TO
THINK CAREFULLY WHY YOU'RE
ENGAGING, WHAT THE ISSUE IS, AND
WHAT IS THE APPROPRIATE WAY IN
WHICH YOU CAN ENGAGE.
AND SOME OF THOSE WILL REQUIRE
SOME QUITE SCIENTIFIC METHOD IN
OUR SETTING WE HAVE USED --
CONSULTATIONS QUITE A LOT, FOR
SOME OF THE REALLY COMPLEX
TOPICS AND WE FOUND IT REALLY
USEFUL.
>> I'LL JUST ADD, I'LL MAYBE
BRING THIS BACK TO WHERE ANNETTE
BROUGHT US IN TALKING ABOUT THE
076 TRIALS, FOR EXAMPLE.
SO ONE CHALLENGE AT THE TIME
MIGHT HAVE BEEN WHY DON'T YOU --
WE COULD TALK ABOUT TWO "YOU"
IS, JUST MAKE SURE THAT ALL THE
WOMEN WHO MAY BENEFIT OUTSIDE OF
THE UNITED STATES HAVE ACCESS TO
THE FULL REGIMEN.
AND LET'S DEVOTE ALL OF OUR
ATTENTION TO THAT.
RIGHT?
THAT COULD HAVE BEEN AN
ALTERNATIVE PATH, BUT BECAUSE WE
LIVE IN A NON-IDEAL SETTING,
THAT WAS NOT FEASIBLE, SO -- BUT
THIS BRINGS UP THE QUESTION OF
HOW OUGHT PUBLIC HEALTH
RESEARCHERS IN PARTICULAR THINK
ABOUT THE SORT OF TENSIONS THEY
MAY EXPERIENCE OF I WANT TO DO
SOMETHING THAT BENEFITS THE
LARGER POPULATION, I KNOW THAT
IN THE PROCESS I'M GOING TO
ENCOUNTER HUMANITARIAN NEED, BUT
I'M NOT NECESSARILY THERE TO
ADDRESS THE HUMANITARIAN NEED,
AND THE TENSION THAT THEY MAY
FEEL ABOUT WANTING TO MAKE A
DIFFERENCE IN THE FUTURE VERSUS
IN REALTIME, JUST TO SAY THAT
THERE ARE, YOU KNOW -- THERE ARE
A LOT OF THINGS GOING ON IN
TERMS OF WHETHER WE MAKE A
DECISION TO FUND OR SUPPORT
PARTICULAR RESEARCH INITIATIVES,
AND AS YOU, I THINK VERY
APPROPRIATELY SAID, RIGHT, THERE
ARE SOME CIRCUMSTANCES WHERE
COMMUNITY COLLABORATION,
PARTICIPATION, ENGAGEMENT, CAN
FACILITATE A GOOD LINEUP BETWEEN
THE NEEDS OF THE COMMUNITY AND
WHAT THE RESEARCHERS WANT TO
ACCOMPLISH, AND TOGETHER,
CONTRIBUTE TO SOMETHING THAT
WILL HELP FUTURE PATIENTS OR THE
LARGER COMMUNITY.
AND IT'S SORT OF THE BIGGER
QUESTION OF, YOU KNOW, DO WE DO
RESEARCH OR DO WE DO SOMETHING
ELSE OR DO WE DO RESEARCH THAT'S
A PARTICULAR DESIGN VERSUS
ANOTHER WHEN YOU'RE THINKING
ABOUT FEASIBILITY AND EFFICIENCY
AND ALL OF THOSE THINGS.
>> YEP.
>> AND I THINK WE'RE AT TIME.
I'M SO SORRY, DORCAS, BUT THANK
YOU AGAIN FOR JOINING US.
AND --
THANK YOU.
LOOK FORWARD TO HEARING FROM
YOU AGAIN.
THANKS A LOT.
THANK YOU SO MUCH!