Gaub-WMA-15_-16_-sept-2015

The$Role$of$Research$Ethics$Committees
Johannes(Gaub,(dr.med.
Governance(Manager,(PERSIMUNE,(Rigshospitalet
Chairman,(National(Ethical(Committee,(2006(D
A(Danish(dilemma
To(conform(D
or(not(to(conform
Conclusions$I
be$sure$to
! Distinguish between wet and(dry(registers
! Protect patient(confidentiality,(enforce
pseudonymization
! Protect registers((dry)(from(distortion
! Allow for(the(revolution(in(bioinformatics
! Use informed consent,(where it(matters – wet
! Strengthen data(security
ween(wet(and(dry(registers
Current$status
Danmark
• Distinction(between(dry((databases)(and(wet(
(biobanks)(registers
• Establishing(and(
• any(use(of(dry(registers,(incl(research, decided(
by(Data(Safety(Board,(since(2003(no(ethical(
approval(of(use(for(research
• Establishing(biobanks (research(bb,(clinical(bb)(
decided(by(Data(Safety(Board,(
• use(for(research(must(have(ethical(approval
Why$differentiate$
between$wet$and$dry$registers?
! Because$requirements$for$consent$are$$
different
! The$uncle$test
! Biobank$material:$ask$for$permission
! Pseudonymized,$dry$data:$only$data$safety$
concerns,$if$any
! Present$Danish$legislation$is$based$on$
this$distinction
Dry(registers
! Danish$registers$are unique
! Uniqe CPR$numbers since 1965
! Access$is$possible to$data$from$many different sources,$collected
for$all$sorts$of$purposes
D Connected via(CPR
D Pseudonymized before delivery to(researcher
Why(is(informed(consent(
irrelevant(in(research(on(dry(registers?
Rationale: Common(sense
! Autonomi/selfdetermination is(exercised in(the(patient’s decisions(
about his(own diagnostics and(treatment AND(participation(in(
research(projects as(subject or(as(source(of(tissue
BUT
! Autonomy/selfdetermination does not(apply to(the(historical record
of(the(patient’s interaction with(the(health care system(and(
healthcare personnel
Why(is(it(so?
! Autonomy is(forward(directed,(and(the(sovereignty of(the(patient(is(unquestioned
WHEREAS
! the(health care record is(a(historical and(legal(document,(containing documentation
of(clinical data,(and(important evidence if(disputes about adverse events(arise
! and pseudonymized,( electronically accessible healthcare data(is(the(”clinical
experience”(of(the(21st(century
BUT$OF$COURSE
! the(patient(decides acces(to(his(IDENTIFIABLE(data
The(crucial(point
! FACT:(When dry(data(is(produced from(wet stage,(it(happens with(
the(patient’s consent,(either to(diagnosis and(treatment,(or(to(
research.
! ANALYSIS: Subsequently the(dry(data(is(part(of(a(common domain,(
where a(patient(is(entitled to(privacy but(not(to(sovereignty regarding
data(substance or(use
! SUGGESTION$ FROM$MANY$SIDES:$Protection of(patient(interests
and(oversight can be provided by(research(ethical committees.
Protection
We(must(protect(patients(from(
disclosure(of(their(identifiable(data
We(need(to(protect(our(registers(from(
distorsion(due(to(incompleteness(and(
biased(withdrawal
Danish$dry$registers
in$important$studies
• Abortion and(risk of(breast cancer
• MFR(vaccination(and(autism
• Twin studies
Paediatric(and(Perinatal(Epidemiology(2011
View(points(that(should
not(be(taken(into(account
! Demanding informed consent before use of(
pseudonymized data
! Neglecting that demand for(informed consent
distorts datasets
! Believing that worry about data(safety is(a(relevant(
argument(for(informed consent
! Believing that controlled access to(psedonymized
data(compromizes patients’(privacy
Conclusions$I
be$sure$to
! Distinguish between wet and(dry(registers
! Protect patient(confidentiality,(enforce
pseudonymization
! Protect registers((dry)(from(distortion
! Allow for(the(revolution(in(bioinformatics
! Use informed consent,(where it(matters – wet
! Strengthen data(security
ween(wet(and(dry(registers
What(do(we(ask(for
! Rules must$be consistent across domains:$Routine clinical work,(
quality assurance,(research
! Effective pseudonymization and$improved data$safety
! Efficient gathering and$use of$clinical experience
! Compatible$with$technological developement:$Genomic
medicine`(big data
What(do(we(need(to(do(?
In(Danmark:(A(limited number of(adjustments of(current regulation
! Emphasize the(dry/wet distinction
! Reintroduce requirement for(ethical approval in(some registry
research(projects
! Drop(requirements for(destruction of(data((persondataloven)(and(
adjust rules concerning access in(relation(to(purpose
Comments$to$draft
document
This(document(concerns(access(to(health(data(and(
biobanks(not(only(for(research(puposes,(but(for(all(
other(purposes
This(is(much(more(challenging,(but(if(handled(
carefully(also(of(great(merit
Data(acces(as(part(of(clinical(practice(is(directed(by((
the(potential(benefit(to(patients
Research(projects(are(for(the(common(good,(
research(subjects(rarely(benefit(directly(–
requirements(are(more(stringent
ween(wet(and(dry(registers
Comments$to$draft
document
Clarify
3(.(.(and(associated(data(.(.(
13(.(.(as(individuals(.(.
18(&(20(.(.(.dedicated(.(.
Change$required
3(.(.(both(give(rise(to(the(same(concerns(.(.(
9,(15(&(17(.(.(identifiable(.(.(
15(.(.(given(the(opportunity(to(decide(.(.
.(.(who(will(have(.(.(.(
19(.(.(anonymous(.(.
21(.(.(approve(all(use(.(.(.
26.1(&(26.3(.(.(purpose(.(.(length(of(time
ween(wet(and(dry(registers
A(Danish(dilemma
To(conform(D
or(not(to(conform