Anales
de
Pedia ía
99
(2023)
195---202
www.analesdepedia ia.o g
SPECIAL
ARTICLE
Resea ch
e hics:
F om
p inciples
o
p ac ical
aspec s
Gonzalo
Solis
Sáncheza,∗,
Guille mo
Alcalde
Bezholdb,
Icia
Al onso
Fa nósc
aHospi al
Uni e si a io
Cen al
de
As u ias,
Uni e sidad
de
O iedo,
Ins i u o
de
In es igación
Sani a ia
del
P incipado
de
As u ias,
O iedo,
As u ias,
Spain
bCEI
OSI
A aba,
Uni e sidad
del
País
Vasco,
Se icio
de
Ne ología,
Hospi al
Uni e si a io
A aba,
Vi o ia,
Vizcaya,
Spain
cComi é
de
É ica
de
la
In es igación
de
Euskadi,
Asociación
Nacional
de
Comi és
de
É ica
en
In es igación,
Vi o ia,
Vizcaya,
Spain
Recei ed
7
June
2023;
accep ed
12
June
2023
A ailable
online
17
Augus
2023
KEYWORDS
E hics;
Resea ch;
Legisla ion;
Da a
p o ec ion
Abs ac
Any
esea ch
conduc ed
on
human
beings
o
human
biological
samples
equi es
a
p io
e hical
assessmen
o
a oid
isks
and
p oblems
o
all
in ol ed
pa ies.
The
legisla ion
in
his
ega d
is
e y
b oad
and
emphasizes
he
sa egua ding
o
pa ien
igh s
in
ela ion
o
he
uni e sal
p inciples
o
au onomy,
bene icence
and
jus ice.
The
p esen
a icle
e iews
he
egula ions
applicable
o
clinical
ials,
obse a ional
s udies
wi h
d ugs,
biobank
p ojec s
o
any
o he
ype
o
s udy
ha
may
be
conduc ed
in
he
heal h
ca e
ield.
I
also
add esses
he
ole
o
esea ch
e hics
commi ees,
da a
p o ec ion
and
he
ounda ions
o
scien i ic
in eg i y.
©
2023
Asociaci´
on
Espa˜
nola
de
Pedia ´
ıa.
Published
by
Else ie
Espa˜
na,
S.L.U.
This
is
an
open
access
a icle
unde
he
CC
BY-NC-ND
license
(h p://c ea i ecommons.o g/licenses/by-nc-nd/
4.0/).
PALABRAS
CLAVE
É ica;
In es igación;
Legislación;
P o ección
de
da os
É ica
en
in es igación:
de
los
p incipios
a
los
aspec os
p ác icos
Resumen
La
ealización
de
cualquie
in es igación
con
se es
humanos
o
sus
mues as
biológ-
icas
equie e
una
alo ación
é ica
p e ia
con
el
in
de
e i a
iesgos
y
p oblemas
a
odos
los
ac o es
del
p oceso.
La
legislación
al
espec o
es
muy
amplia
y
hace
hincapié
en
la
p ese ación
de
los
de echos
de
los
pacien es
en
elación
con
los
p incipios
uni e sales
de
au onomía,
bene -
icencia
y
jus icia.
En
es e
manusc i o
se
e isan
las
no ma i as
sob e
ensayos
clínicos,
es udios
obse acionales
con
medicamen os,
p oyec os
de
biobanco
o
cualquie
o o
ipo
de
es udio
que
se
pueda
ealiza
en
el
ámbi o
de
la
salud.
Así
mismo
se
analiza
el
papel
de
los
comi és
de
é ica
en
In es igación,
la
p o ección
de
da os
y
las
bases
de
la
in eg idad
cien í ica.
©
2023
Asociaci´
on
Espa˜
nola
de
Pedia ´
ıa.
Publicado
po
Else ie
Espa˜
na,
S.L.U.
Es e
es
un
a ´
ıculo
Open
Access
bajo
la
licencia
CC
BY-NC-ND
(h p://c ea i ecommons.o g/licenses/by-
nc-nd/4.0/).
∗Co esponding
au ho .
E-mail
add ess:
[email p o ec ed]
(G.
Solis
Sánchez).
2341-2879/©
2023
Asociaci´
on
Espa˜
nola
de
Pedia ´
ıa.
Published
by
Else ie
Espa˜
na,
S.L.U.
This
is
an
open
access
a icle
unde
he
CC
BY-NC-ND
license
(h p://c ea i ecommons.o g/licenses/by-nc-nd/4.0/).
G.
Solis
Sánchez,
G.
Alcalde
Bezhold
and
I.
Al onso
Fa nós
In oduc ion
Biomedical
esea ch
mus
be
conduc ed
in
adhe ence
o
uni e sally
ecognised
e hical
p inciples
ha
ensu e
he
ad ancemen
o
knowledge,
he
imp o emen
o
he
human
condi ion
and
he
p og ess
o
socie y,
always
sa egua ding
he
digni y
and
au onomy
o
human
beings.
Mo e
ecen ly,
hese
p inciples
ha e
add essed
aspec s
such
as
he
p o-
ec ion
o
pe sonal
da a,
animal
wel a e
and
en i onmen al
conse a ion.1
We
do
no
need
o
go
a
back
in
his o y
o
unde s and
he
need
o
e hics
in
esea ch.
A icles
like
he
one
published
by
Beeche 2in
1966,
o
expe imen s
like
he
Tuskegee
s udy
conduc ed
h ough
1972
in
Alabama,
in
he
Uni ed
S a es,3
e ince
he
need
o
be
uncomp omising
in
his
ega d.
In
he
ield
o
paedia ics,
as
would
be
expec ed,
esea ch
has
also
no
been
ee
o
e hical
p oblems.
The
example
o
he
scan-
dal
o
expe imen s
a
he
Willowb ook
S a e
School4and
he
ole
o
Saul
K ugman5in
his
con o e sy
a e
s udied
in
e e y
cou se
in
bioe hics,
and
hey
a e
bu
a
sample
o
a
my iad
ins ances
ha
could
be
ci ed.
Al hough
he e
ha e
been
adical
changes
in
ou
wo ld
since
he
publica ion
o
he
e hical
p inciples
o
he
Decla-
a ion
o
Helsinki
o
he
Wo ld
Medical
Associa ion
in
19646
o
he
Belmon
Repo
in
1978,7 oday
i
is
s ill
necessa y
o
ensu e
s ic
con ols
in
any
esea ch
p ojec ,
howe e
small
and
banal
i
may
seem,
i
we
a e
o
a oid
epea ing
e o s
o
he
pas .
Fo
his
eason,
we
hough
i
would
be
ele an
o
publish
an
a icle
summa ising
heo e ical
and
p ac ical
aspec s
conce ning
esea ch
e hics
and,
o
some
ex en ,
scien i ic
in eg i y
in
ou
socie y.
Spanish
legisla ion
on
he
subjec
The
Spanish
legisla ion
on
he
subjec
is
ex ensi e
and
a -
ied,
al hough
some
aspec s
s ill
equi e
u he
elabo a ion
(Table
1).
Al hough
he
Spanish
Cons i u ion
al eady
men-
ions
he
igh
o
p i acy,
i
is
Law
41/2002
on
he
Au onomy
o
he
Pa ien 8 ha
he alded
a
se ies
o
legal
ex s
ha
ha e
been
momen ous
in
shaping
esea ch
e hics
in
Spain.
This
law
ecognises
he
igh
o
he
con iden iali y
o
pe sonal
heal h
da a
o
e e y
indi idual,
and
denies
e e yone
he
igh
o
access
pe sonal
heal h
ca e
da a
wi hou
he
p io
au ho iza ion
o
he
indi idual
in
ques ion,
hus
se ing
he
ounda ions
o
he
concep
o
in o med
consen
ha
has
since
become
indispensable
in
biomedical
esea ch.
The
second
undamen al
law
on
he
subjec
is
Law
14/2007
on
Biomedical
Resea ch,9which,
in
addi ion
o
s a -
ing
in
i s
p eamble
ha
heal h
ca e
esea ch
is
c ucial
wi h
he
aim
o
imp o ing
he
li es
o
he
ci izens,
manda es
ha
a
esea ch
e hics
commi ee
(REC)
e alua e
any
biomedical
esea ch
p ojec
in ol ing
in e en ions
on
human
beings
o
he
use
o
biological
samples.
Thus,
he
scope
o
he
e hical
o e sigh
assigned
o
RECs
in
he
legisla ion
on
clinical
ials
was
expanded
o
apply
o
all
biomedical
esea ch.
This
law
dic a es
ha
esea ch
in
humans
can
only
be
conduc ed
i
he e
is
no
expe imen al
al e na i e
o
compa able
e icacy,
mus
no
en ail
isks
o
discom o
ha
a e
disp opo iona e
in
ela ion
o
he
po en ial
bene i s
o
he
subjec
and,
i
i
does
no
o e
po en ial
di ec
bene i s
o
i s
subjec s,
can
only
be
unde aken
i
he
REC
esponsible
o
e alua ing
he
p ojec
conside s
ha
i
poses
a
minimum
isk
o
hem.
A
Royal
Dec ee
(RD)
ha
is
key
in
biomedical
esea ch
is
RD
1716/2011
egula ing
biobanks.10 This
RD
egula es
all
aspec s
pe aining
o
he
handling,
s o age
and
ci cula ion
o
biological
samples.
I
es ablishes
ha
biological
samples
o
human
o igin
collec ed
o
esea ch
may
be
s o ed
in
p i-
a e
collec ions,
ga he ed
o
speci ic
p ojec s
o
cus odied
in
biobanks.
Each
ype
o
collec ion
mus
be
managed
di -
e en ly,
and
biobanks
equi e
an
ex e nal
e hics
commi ee
o
e alua e
sample
p ocu emen
eques s
om
an
e hics
s andpoin ,
in
addi ion
o
an
ex e nal
scien i ic
commi ee
o
e alua e
he
esea ch
p ojec s.
Bu
i
is
unques ionably
RD
1090/2015,
which
egula es
andomised
con olled
ials
(RCTs)
wi h
medicines,
speci ic
e hics
commi ees
o
he
e alua ion
o
esea ch
in ol -
ing
medicines
(REC-M)
and
he
Regis o
Espa˜
nol
de
Es udios
Clínicos
(REec,
Spanish
Regis e
o
Clinical
T ials),11 ha
has
had
he
g ea es
impac
on
he
unc ioning
o
RECs.
I
was
o
ul il
he
equi emen s
o
Regula ion
EU
No
536/2014
and
esul ed
in
a
signi ican
o e haul
in
he
wo k
o
he
com-
mi ees
and
he
imposi ion
o
he
single
opinion
di ec i e.
This
RD
speci ies
in
de ail
he
ole
o
REC-Ms
in
he
e al-
ua ion
o
me hodological
aspec s,
he
app op ia eness
o
he
acili ies,
he
quali ica ions
o
he
p incipal
in es iga-
o s,
in o ma ion
documen s
and
in o med
consen
as
well
as
aspec s
pe aining
o
da a
p o ec ion,
secu ing
insu ance
and
he
collec ion
o
e alua ion
ees.
Con inuing
in
ch onological
o de ,
i
is
impo an
o
now
men ion
O de
SSI/81/201712 ega ding
he
igh
o
p i acy
o
he
pa ien s
in
ela ion
o
s uden s
and
esiden s
in
medi-
cal
and
heal h
sciences,
which
es ablishes
ha
s uden s
will
no
be
allowed
access
o
pa ien
da a
ha
has
no
been
anonymised
unless
he
pa ien
p o ides
in o med
consen
i s .
O ganic
Law
3/2018
o
5
Decembe
on
he
P o ec ion
o
Pe sonal
Da a
and
Gua an ee
o
Digi al
Righ s
(OLPD-GDD),
w i en
o
he
applica ion
o
Regula ion
(EU)
2016/679
on
he
p o ec ion
o
pe sonal
da a
a
he
Eu opean
le el,
egula es
he
handling
o
da a
in
medical
and
heal h
esea ch
in
i s
addi ional
p o ision
17.13,14 This
law
es ab-
lishes
he
ole
o
RECs
in
he
e alua ion
o
s udies
ha
use
heal h- ela ed
da a,
whe he
pe sonally
iden i iable,
pseudonymised
o
anonymised,
imposing
new
equi emen s
ega ding
he
composi ion
o
hese
commi ees,
such
as
he
need
o
ha e
a
da a
p o ec ion
delega e
o ,
ailing
ha ,
an
expe
on
he
subjec .
On
he
o he
hand,
RD
957/2020
on
Obse a ional
S udies
wi h
Medicines
(OSMs)
used
in
humans15 eplaced
O de
SAS/3470/200916 egula ing
obse a ional
pos ma -
ke ing
s udies
(PMSs)
wi h
medicines
(EPA).
This
RD
no
only
changed
he
e m
PMS
o
OSM,
bu
also
modi ied
and
simpli ied
he
s eps
equi ed
o
app o e
pos ma ke ing
su eillance
s udies,
which
a e
needed
o
ensu e
he
e ec-
i eness
and
sa e y
o
d ugs
in
eal
wo ld
clinical
p ac ice,
elimina ing
he
equi emen
o
ob aining
he
classi ica ion
as
such
a
s udy
om
he
Agencia
Espa˜
nola
de
Medicamen os
y
P oduc os
Sani a ios
(AEMPS,
Spanish
Agency
o
Medicines
and
Medical
De ices)
as
an
ini ial
s ep.
We
end
his
e iew
wi h
he
ecen ly
app o ed
s a u es
o
he
Comi é
Espa˜
nol
de
É ica
de
la
In es igación
(Spanish
Commi ee
o
Resea ch
E hics),17 an
o ganiza ion
ins i u ed
196
Anales
de
Pedia ía
99
(2023)
195---202
Table
1
Spanish
legisla ion
on
he
subjec
o
esea ch
e hics.
Legisla ion
Key
poin s
Spanish
Cons i u ion
o
1978 --- Righ
o
honou ,
pe sonal
and
amily
p i acy
and
con ol
o
one’s
own
image
Law
41/2002
on
he
Au onomy
o
he
Pa ien
---
Con iden iali y
o
heal h
ca e
da a
---
Need
o
au ho iza ion
o
access
da a
---
Founda ions
o
in o med
consen
Law
14/2007
on
Biomedical
Resea ch
---
Manda es
e alua ion
by
a
REC
o
any
s udy
in ol ing
human
beings
o
human
biological
samples
Royal
Dec ee
1716/2011
egula ing
biobanks
---
Speci ies
he
unc ions
and
ope a ion
o
biobanks
Royal
Dec ee
1090/2015
egula ing
clinical
ials
wi h
medicines
---
Regula es
RCTs
acco ding
o
Eu opean
di ec i es
---
Single
opinion
di ec i e
---
In oduces
REC-Ms
O de
SSI/81/2017
on
he
igh
o
p i acy
o
pa ien s
in
ela ion
o
medical
and
heal h
science
s uden s
and
esiden s
---
P ohibi s
access
o
pa ien
da a
o
s uden s,
unless
he
da a
a e
dissocia ed
o
he
pa ien
p o ides
in o med
consen
Law
3/2018
on
he
P o ec ion
o
Pe sonal
Da a
and
Gua an ee
o
Digi al
Righ s
---
P o ision
17
e e s
o
heal h- ela ed
da a
---
Es ablishes
he
legal
de ini ion
o
anonymised
and
pseudonymised
da a
---
RECs
mus
ha e
an
expe
on
da a
Royal
Dec ee
957/2020
on
Obse a ional
S udies
wi h
Medicines
used
in
humans
---
Replaces
he
concep
o
pos ma ke ing
su eillance
s udies
by
he
concep
o
obse a ional
s udy
wi h
d ugs,
modi ying
applicable
egula ions
RCT,
andomised
con ol
ial;
REC,
esea ch
e hics
commi ee;
REC-M,
e hics
commi ee
o
he
e alua ion
o
esea ch
in ol ing
medicines.
in
201118 and
dependen
on
he
Consejo
de
Polí ica
Cien-
í ica,
Tecnológica
y
de
Inno ación
(Council
o
Scien i ic,
Technological
and
Inno a ion
Policy),
an
o icial,
indepen-
den
and
ad iso y
body
on
ma e s
ela ed
o
esea ch
e hics
and
scien i ic
in eg i y.
The
unc ions
o
his
commi ee,
among
o he s,
a e
o
es ablish
he
gene al
p inciples
o
he
de elopmen
o
good
p ac ice
guidelines
in
esea ch,
includ-
ing
ecommenda ions
o
p e en ,
de ec ,
add ess,
a oid
and
esol e
con lic s
o
in e es .
Documen s
o
a
non-legal
na u e/e hical
guidelines
The
P ussian
egula ion
o
1900,
de eloped
in
esponse
o
he
Neisse
case,
is
conside ed
he
i s
mode n
documen
o
esea ch
e hics
in
he
Wes .19,20 La e
on,
he
Nu embe g
code
o
1947
was
he
i s
o
clea ly
and
concisely
spec-
i y
he
essen ial
p inciples
in
esea ch:
olun a y
consen ,
good
o
socie y,
p e ious
esul s
jus i ying
he
expe imen ,
a oidance
o
unnecessa y
physical
o
psychological
su e -
ing,
a
a ou able
isk-bene i
assessmen ,
p o ec ion
o
he
pa ien ,
quali ica ion
o
esea che s,
igh
o
d op
ou
o
he
s udy
and
possibili y
o
s opping
he
s udy
i
needed.21 S ill,
he e
we e
limi a ions
o
he
Nu embe g
code,
chie
among
hem
ha
i
applied
only
o
expe imen a ion
on
heal hy
olun a y
pa icipan s,
p io i ised
he
in e es s
o
socie y,
placed
limi a ions
on
he
condi ions
unde
which
pa ici-
pan s
could
d op
he
s udy
and
did
no
con empla e
ex e nal
e hics
e iews.
I
p o ided
gene al
ecommenda ions
ha
had
no
legal
weigh .
The
Wo ld
Medical
Associa ion
issued
he
e hical
p inci-
ples
o
he
Decla a ion
o
Helsinki
in
1964,
which
has
since
been
upda ed
in
successi e
edi ions,
he
la es
app o ed
in
Fo aleza
(B azil)
in
2013.
The
pu pose
o
he
Decla-
a ion
was
o
sa egua d
he
digni y
o
he
indi idual
and
he
p i acy
o
pa ien s
in
esea ch.
I
es ablished
se e al
equi emen s
o
an
expe imen al
s udy
o
be
conside ed
app op ia e,
among
which
we e
he
p io
de elopmen
o
a
ull
expe imen al
p o ocol,
e iewed
and
app o ed
by
an
independen
e hics
commi ee,
wi h
subsequen
o e sigh
and
moni o ing
o
he
s udy.
I
also
equi ed
ha
s udies
be
led
by
quali ied
p o essionals
and
ha
he
bene i s
o
he
s udy
ou weigh
i s
isks.
Be o e
ag eeing
o
pa icipa e,
subjec s
had
o
be
in o med
in
de ail
abou
he
p ocedu es
in ol ed
in
he
expe imen ,
any
isks
and
any
ci cums ances
ha
may
a ec
he
ou comes.
Pa icipan s
had
o
gi e
hei
consen
eely,
and
could
no
be
subjec
o
coe cion,
p es-
su e
o
decep ion.
In
he
case
o
indi iduals
no
ully
able
o
p o ide
i ,
consen
has
o
be
p o ided
by
he
legal
gua dian.
Las ly,
he
Decla a ion
s a es
he
obliga ion
o
esea che s
o
publish
comple e
and
accu a e
esul s,
whe he
hey
a e
a ou able
o
no .
In
1978,
he
Belmon
Repo
(e hical
p inciples
and
guide-
lines
o
he
p o ec ion
o
human
subjec s
in
esea ch)
was
published
in
esponse
o
he
in amous
Tuskegee
197
G.
Solis
Sánchez,
G.
Alcalde
Bezhold
and
I.
Al onso
Fa nós
Table
2
Chie
non-legal
documen s
on
esea ch
e hics.
Documen
Key
poin s
P ussian
Regula ion(1900)
---
Fi s
mode n
documen
on
he
subjec
Nu embe g
Code
(1947)
---
Es ablishes
he
co e
p inciples
o
esea ch
e hics
Decla a ion
o
Helsinki
o
he
Wo ld
Medical
Associa ion
(1964)
---
Es ablishes
equi emen
o
a
s udy
p o ocol
and
e alua ion
by
a
REC
---
Quali ied
p o essionals
---
Risk/bene i
assessmen
---
In o ma ion
and
ee
consen
o
pa icipan s
---
Allows
consen
by
a
legally
au ho ised
ep esen a i e
--- Commi men
o
publica ion
o
esul s
Belmon
Repo
(e hical
p inciples
and
guidelines
o
he
p o ec ion
o
human
subjec s
in
esea ch)
(1978)
--- Essen ial
p inciples
o
bioe hics:
au onomy,
bene icence
and
jus ice
In e na ional
E hical
Guidelines
o
Biomedical
Resea ch
In ol ing
Human
Subjec s
(CIOMS-WHO)
(1982)
---
E hical
issues
in
de eloping
coun ies
---
Co e
p inciples
and
commen a y
on
hei
in e p e a ion
Good
Clinical
P ac ice
(GCP)
guidelines
(1995)
---
In e na ional
guidance
(Eu ope,
Japan
and
USA)
o
pe o mance
o
RCTs
---Du ies
and
esponsibili ies
o
he
di e en
in ol ed
pa ies
---S anda d
p ocedu es
o
designing,
conduc ing,
eco ding
and
epo ing
RCTs
Uni e sal
Decla a ion
on
Bioe hics
and
Human
Righ s
o
he
UNESCO
(2005)
---
Expanded
he
scope
o
include
esea ch
e hics
CIOMS,
Council
Fo
In e na ional
O ganiza ions
O
Medical
Sciences;
GCP,
Good
Clinical
P ac ice;
RCT,
andomised
clinical
ial;
REC,
esea ch
e hics
commi ee;
UNESCO
Uni ed
Na ions
Educa ional,
Scien i ic
and
Cul u al
O ganiza ion;
WHO,
Wo ld
Heal h
O ganiza ion.
syphilis
s udy,
conduc ed
in
A ican
Ame icans,
which
was
denounced
by
he
p ess
in
he
Uni ed
S a es.
The
epo
es ablished
he
3
co e
p inciples
o
bioe hics:
espec
o
pe sons
(au onomy),
bene icence
and
jus ice.7,22
The
p inciple
o
au onomy
s ands
o
he
igh
o
all
pe -
sons
o
be
ea ed
as
au onomous
indi iduals
and
hose
who
canno
be
au onomous
o
be
p o ec ed,
and
con empla es
au onomy
as
changing
h oughou
he
li espan
and
po en-
ially
equi ing
e-e alua ion.
Au onomy
is
he
co e
p inciple
unde lying
he
need
o
p o ide
in o ma ion
abou
he
s udy
and
ob ain
in o med
consen .
The
p inciple
o
bene icence,
and
i s
subsequen
elabo a ion
in
he
p inciple
o
nonmale i-
cence,
e e s
o
he
obliga ion
o
assess
he
isk
and
bene i s
in
e e y
ins ance
and
o
maximise
he
la e .
This
p inciple
is
he
eason
ha
RECs
always
assess
he
s udy
design
and
me hods.
Las ly,
he
p inciple
o
jus ice
calls
o
equi able
selec ion
o
s udy
pa icipan s
wi h
an
equi able
dis ibu ion
o
he
expec ed
isks
and
bene i s.23,24
In
1982,
he
Council
o
In e na ional
O ganiza ions
o
Medical
Sciences
(CIOMS)
published
he
In e na ional
E hical
Guidelines
o
Biomedical
Resea ch
In ol ing
Human
Sub-
jec s
in
collabo a ion
wi h
he
Wo ld
Heal h
O ganiza ion
(WHO).
These
guidelines,
whose
ou h
edi ion
was
pub-
lished
in
2016,
add essed
esea ch
e hics
issues
pa icula
o
de eloping
coun ies,
comp ising
25
co e
guidelines
wi h
commen a ies.25,26
Ano he
essen ial
documen
was
he
Uni e sal
Decla a-
ion
on
Bioe hics
and
Human
Righ s
o
he
Uni ed
Na ions
Educa ional,
Scien i ic
and
Cul u al
O ganiza ion
(UNESCO)
o
2005,
which
add essed
he
sa egua ding
o
human
digni y
and
igh s,
au onomy,
ulne abili y
and
in eg i y,
p i acy
and
con iden iali y,
jus ice
and
equi y,
he
espec
o
di e -
si y,
social
esponsibili y,
solida i y
and
coope a ion,
he
p o ec ion
o
u u e
gene a ions
and
he
p o ec ion
o
he
en i onmen .27
To
conclude,
we
ough
o
men ion
he
Good
Clinical
P ac-
ice
(GCP)
guideline
o
he
de
la
In e na ional
Council
o
Ha monisa ion
o
Technical
Requi emen s
o
Pha maceu i-
cals
o
Human
Use
(ICH).
I
is
an
in e na ional
e hical
and
scien i ic
quali y
s anda d
o
designing,
conduc ing,
eco d-
ing
and
epo ing
ials
ha
in ol e
he
pa icipa ion
o
human
subjec s.
Adhe ence
o
i
ensu es
he
p o ec ion
o
he
igh s,
sa e y
and
wellbeing
o
ial
pa icipan s
and
he
eliabili y
o
esul s.
Among
he
ICH
guidelines
o
he
pe -
o mance
o
clinical
ials,
i
is
wo h
highligh ing
he
E11
documen ,
which
ocuses
on
he
paedia ic
popula ion.28,29
Table
2
p esen s
a
succinc
summa y
o
he
mos
impo -
an
non-legal
documen s
on
he
subjec .
Resea ch
e hics
commi ees
The
o igin
o
RECs
in
Spain
goes
back
o
he
second
hal
o
he
pas
cen u y.
Al hough
in
some
hospi als
he e
we e
al eady
g oups
ha
assessed
e hical
aspec s
in
some
man-
ne ,
he
ea lies
e e ence
o
hei
exis ence
in
Spain
in
a
legal
con ex
is
ound
in
a
oyal
dec ee
om
1978
(RD
944/1978),38 since
ollowed
by
se e al
oyal
dec ee
and
min-
is e ial
o de s
ha
ha e
been
speci ying
hei
unc ions
and
s uc u e,
ela ed
legisla ion
and
de ini ions.
Bu
i
was
he
Law
on
Biomedical
Resea ch
o
20079 ha
es ablished
he
198
Anales
de
Pedia ía
99
(2023)
195---202
Table
3
Resea ch
e hics
commi ees
(RECs
and
REC-Ms)
in
Spain
( egis e
o
he
Agencia
Espa˜
nola
del
Medicamen o
y
P oduc os
Sani a ios).
Au onomous
Communi y Scope
o
REC-M
REC-M
REC
Andalusia
P o ince/au onomous
communi y
8
4
A agón
Au onomous
communi y
1
As u ias
Au onomous
communi y
1
Can ab ia
Au onomous
communi y
1
Cas illa
León Local/p o ince
9
Cas illa-La
Mancha Local
6
1
Ca alonia
Local
24
5
Valencia Local
12
9
Ex emadu a
Au onomous
communi y
1
1
Galicia
Au onomous
communi y
1
3
Balea ic
Islands
Au onomous
communi y
1
Cana y
Islands
P o ince/local
2
La
Rioja Au onomous
communi y 1
Mad id
Local/ egional
18
1
Mu cia
Local
2
2
Na a e
Au onomous
communi y 1
Basque
Coun y
Au onomous
communi y
1
5
To al
90
31
REC,
esea ch
e hics
commi ee;
REC-M,
e hics
commi ee
o
he
e alua ion
o
esea ch
in ol ing
medicines.
equi emen
o
app o al
by
a
REC
o
any
s udy
in ol ing
esea ch
in
human
beings
o
human
biological
samples.
Royal
Dec ee
1090/2015
de ines
RECs
as
independen
bodies
wi h
a
mul idisciplina y
composi ion
whose
main
pu -
pose
is
o
sa egua d
he
igh s,
sa e y
and
wellbeings
o
pa icipan s
in
biomedical
esea ch
and
o
p o ide
a
gua an-
ee
o
e hical
ea men
by
uling
on
he
esea ch
p oposal,
aking
in o
accoun
he
pe spec i e
o
laype sons,
and
pa -
icula ly
o
pa ien s
o
pa ien
o ganiza ions.
This
dec ee
(RD
1090/2015)
de ined
he
ole
o
REC-Ms
(RECs
wi h
he
au ho i y
o
au ho ise
RCTs
wi h
pha ma-
ceu icals),
in
addi ion
o
hei
s uc u e
and
unc ioning,
s ipula ing
ha
hey
need
o
be
acc edi ed
by
he
compe-
en
heal h
au ho i ies
and
ha
nei he
he
REC-M
as
a
whole
o
any
o
i s
membe s
can
ecei e
any
di ec
o
indi ec
emune a ion
om
ial
sponso s.
Fu he mo e,
in
ela ion
o
he
e alua ion
o
RCTs
conduc ed
in
mino s,
i
es ablished
ha
REC-Ms
had
o
include
membe s
who
we e
expe s
in
paedia ics
o
seek
consul a ion
ega ding
clinical,
e hical
and
psychosocial
issues
speci ic
o
he
ield
o
paedia ics.
The
du y
o
hese
commi ees
(RECs
o
REC-Ms)
is
o
uphold
scien i ic
and
me hodological
igou ,
e i y
adhe -
ence
o
cu en
egula ions
and
e hical
p inciples
and
gua an ee
he
wellbeing
and
sa e y
o
esea ch
pa ici-
pan s.
I
is
also
esponsible
o
e alua ing
any
ele an
modi ica ions
o
au ho ised
s udies
and
o
moni o
hem
un il
he
inal
epo
is
p oduced.
Al hough
ini ially
his
only
applied
o
he
e alua ion
o
RCTs,
he
scope
o
hese
commi ees
cu en ly
includes
he
e alua ion
o
any
s udy
in ol ing
human
pa icipan s,
pa ien
da a
o
human
biolog-
ical
samples,
ega dless
o
i s
me hodological
design
and/o
complexi y.
Acco ding
o
he
AEMPS
egis e
o
2021,
he e
a e
90
acc edi ed
REC-Ms
in
Spain39 (Table
3).
The
scope
o
REC-Ms
is
e y
b oad,
o
ins ance,
he e
a e
commi ees
o
egional
o
p o incial
scope,
and
commi ees
ha
ope a e
a
he
hos-
pi al
o
ins i u ional
le el.
The
only
commi ees
acc edi ed
o
e alua e
s udies
in ol ing
d ugs
o
medical
p oduc s
and
de ices
a e
REC-Ms,
while
RECs
can
e alua e
all
o he
ypes
o
p ojec s.
In
2011,
he
Asociación
Nacional
de
Comi és
de
É ica
en
In es igación
(ANCEI,
Na ional
Associa ion
o
Resea ch
E hics
Commi ee)40 was
c ea ed
in
Spain,
which
has
since
ca ied
ou
ele an
ac i i y
in
he
p omo ion
o
ins i u ional
collabo a ion,
ep esen a ion
and
educa ion.
The
associa-
ion
collabo a es
wi h
RECs/REC-Ms
in
he
de elopmen
o
hei
ac i i y,
p omo ing
eamwo k
and
de eloping
guidance
ma e ials
ha
a e
published
pe iodically.
Handling
o
pe sonal
da a
The
p o ec ion
o
he
p i acy
o
indi iduals
subjec
o
esea ch
( hei
image,
pe sonal
in o ma ion
and
digni y)
and
he
con iden iali y
in
he
managemen
o
pe sonal
da a
by
esea che s
a e
wo
key
aspec s
in
conduc ing
esea ch
in
he
ield
o
heal h.
The
Law
on
he
Au onomy
o
he
Pa ien 8 es ic s
he
use
o
da a
documen ed
in
heal h
ca e
eco ds,
and
consen
mus
be
ob ained
om
pa ien s
o
use
his
in o ma ion
o
any
o he
pu pose,
including
esea ch.
Thus,
in o med
con-
sen
is
essen ial
in
esea ch
e hics
as
a
means
o
gua an ee
adhe ence
o
he
p inciple
o
au onomy.
Howe e ,
as
we
will
discuss
u he
down,
he
condi ions
o
access
o
heal h
ca e
eco ds
wi h
esea ch
pu poses
ha e
been
modi ied
wi h
he
enac men
o
he
OLPD-GDD,
includ-
ing
he
speci ic
esea ch
scena ios
con empla ed
in
he
law
as
excep ions
in
which
access
o
heal h
eco ds
is
pe mi ed
wi hou
consen .
Regula ion
(EU)
2016/679
on
da a
p o ec ion
(REUDP)
es ablishes
he
p inciples
ha
apply
o
he
handling
o
heal h- ela ed
da a,
gene ally
allowing
hei
use
o
sci-
199
G.
Solis
Sánchez,
G.
Alcalde
Bezhold
and
I.
Al onso
Fa nós
Table
4
Requi emen s
imposed
by
O ganic
Law
on
he
P o ec ion
o
Pe sonal
Da a
and
Gua an ee
o
Digi al
Righ s
(OLPD-GDD
2018)
o
he
handling
o
heal h- ela ed
da a
i
biomedical
esea ch.
1.
Consen
The
pe inen
pa ies
(o
legal
gua dians)
can
p o ide
consen
o
he
use
o
hei
pe sonal
da a
o
he
pu poses
o
medical
o
heal h
ca e
esea ch.
2.
Wai e
o
in o med
consen
in
excep ional
si ua ions
Heal h
ca e
au ho i ies
in ol ed
in
public
heal h
su eillance
can
ca y
ou
scien i ic
s udies
wi hou
he
consen
o
he
in ol ed
pa ies
i
he
esea ch
in
he
e en
o
a
public
heal h
h ea
in
which
he
esea ch
is
o
excep ional
ele ance.
3.
Reuse
o
da a
The
euse
o
pe sonal
da a
o
heal h
esea ch
is
conside ed
law ul
and
compa ible
wi h
e hical
s anda ds
i
he
da a
a e
used
o
pu poses
o
in
ields
o
esea ch
ela ed
o
he
o iginal
s udy.
4.
Pseudonymiza ion ---The
eam
esponsible
o
pe o ming
he
pseudonymiza ion
and
he
esea ch
eam
mus
be
echnically
and
unc ionally
sepa a e
---
The
pseudonymiza ion
o
da a
en ails
a
commi men
o
con iden iali y
and
o
p e en
eiden i ica ion.
---
Access
o
hi d
pa ies
mus
be
denied.
---
Reiden i ica ion
will
only
be
allowed
in
he
e en
o
a
heal h
p oblem
o
h ea
o
he
sa e y
o
he
subjec ,
a
se ious
h ea
o
he
subjec ’s
igh s,
o
o
gua an ee
p o ision
o
heal h
ca e.
en i ic
pu poses.
Howe e ,
al hough
his
use
is
allowed,
i
mus
be
p opo iona e
o
he
in ended
pu pose,
comply
wi h
da a
p o ec ion
igh s
and
be
subjec
o
he
measu es
necessa y
o
p o ec
he
igh s
and
in e es s
o
esea ch
subjec s.
The
OLDP-GDD13 adop s
he
p inciples
o
he
REUPD,
e e ing
o
he
need
o
anspa ency
and
adhe ence
o
he
law
in
da a
handling,
limi s
o
he
use
o
da a
based
on
i s
pu poses,
he
minimiza ion
and
accu acy
o
da a
p ocess-
ing,
limi a ions
o
he
amoun
o
ime
da a
can
be
s o ed
and
he
in eg i y
and
con iden iali y
o
he
da a.
The
sec-
ond
sec ion
o
addi ional
p o ision
17
is
de o ed
o
da a
handling
in
heal h
and
medical
esea ch,
speci ying
ha
i
equi es
p io
app o al
by
a
REC
and
es ablishing
ce ain
equi emen s
(Table
4).
A
ecen
no el y,
he
pseudonymiza ion
o
da a
allows
access
o
heal h
eco ds
o
esea ch
pu poses
wi hou
equi ing
consen
om
he
subjec s.
The
a ionale
o
eques ing
a
wai e
o
in o med
consen
mus
be
p esen ed
o
he
compe en
commi ee,
which
mus
de e mine
in
each
case
whe he
he
es ablished
condi ions
a e
me .
Commi -
ees
can
also
wai e
he
need
o
consen
in
e ospec i e
s udies
in
which
he
e o
in ol ed
in
ob aining
consen
is
excessi e
o
he
pu poses
o
he
s udy
(dea hs,
changes
in
add ess)
i
loss
o
ha
da a
could
be
a
sou ce
o
bias
in
he
esul s,
and
only
i
anonymiza ion
o
pseudonymiza ion
o
he
da a
a e
no
possible.
When
i
comes
o
clinical
ials
in
he
paedia ic
age
g oup,
i
is
impo an
o
ake
in o
accoun
he
need
o
ob ain
in o ma ion
suppo ed
by
e idence
o
p e en
he
use
o
unapp o ed
d ugs
o
o
app o ed
d ugs
o
indica ions
no
app o ed
in
he
summa y
o
p oduc
cha ac e is ics.41---43 In
his
ega d,
we
ough
o
highligh
he
di ec i e
o
he
Law
on
Biomedical
Resea ch
ha
es ablishes
ha
‘‘consen
by
p oxy
may
be
accep able
when
he
indi idual
is
no
legally
compe-
en
on
accoun
o
disabili y,
impai men
o
being
a
mino ,
and
only
i
he e
a e
no
o he
al e na i es
o
esea ch’’
and
ha
‘‘indi iduals
wi h
disabili y
and
mino s
will
pa -
icipa e
o
he
ex en
possible
and
depending
on
hei
age
and
capaci ies
in
decision-making
h oughou
he
esea ch
p ocess.’’
Scien i ic
in eg i y
and
codes
o
good
scien i ic
p ac ice
The
Na ional
Decla a ion
on
Scien i ic
In eg i y
signed
by
he
Con ede ación
de
Sociedades
Cien í icas
de
Espa˜
na
(COSCE,
Alliance
o
Scien i ic
Socie ies
o
Spain),
he
Comisión
de
Rec o es
de
Uni e sidades
Espa˜
nolas
(CRUE,
Commi ee
o
Spanish
Uni e si y
Rec o s)
and
he
Cen o
Supe io
de
In es-
igación
Cien í ica
(CSIC,
Spanish
Na ional
Resea ch
Council)
in
2015
s a es
ha
scien i ic
in eg i y
is
di ec ly
associa ed
wi h
he
scien i ic
igou ,
excellence
and
quali y
o
esea ch
in
addi ion
o
e hical
and
esponsible
conduc
in
scien i ic
wo k.30 The e o e,
we
speak
o
scien i ic
in eg i y
when
we
discuss
he
p inciples,
alues
and
esponsibili ies
ha
a e
he
basis
o
good
scien i ic
p ac ice.
The
Singapo e
S a e-
men
o
201031 es ablished
4
co e
p inciples:
hones y
in
all
aspec s
o
esea ch,
accoun abili y
in
he
conduc
o
esea ch,
p o essional
cou esy
and
ai ness
in
wo king
wi h
o he s
and
good
s ewa dship
o
esea ch
on
behal
o
o he s.
Scien i ic
in eg i y
mus
be
main ained
a
e e y
s ep
o
he
esea ch
p ocess,
om
he
o mula ion
o
ques ions
o
he
communica ion
o
esul s,
h ough
he
me hodological
design,
execu ion
and
analysis
o
he
indings,
wi hou
o -
ge ing
ha
i
also
applies
o
he
wo k
se ing,
bo h
in
he
in e ac ion
be ween
p o essionals
and
in
hei
quali i-
ca ions.
In eg i y
is
a
mo al
impe a i e
ha
is
sha ed
by
e e y
pa y
in ol ed
in
esea ch,
including
in es iga o s,
adminis a o s,
ins i u ions,
unding
agencies,
publishe s
and
scien i ic
socie ies.
The
pu sui
o
scien i ic
in eg i y
has
led
o
he
de elop-
men
o
wha
is
known
as
good
scien i ic
p ac ice
guidelines,
which,
while
no
eplacing
legisla ion,
o e
di ec i es
o
ein o ce
e hical
s anda ds,
p omo e
esea ch
quali y
and
p e en
misconduc .
Nea ly
all
socie ies
o
ins i u ions
ela ed
o
esea ch
ha e
a
good
scien i ic
p ac ice
code,
200
Anales
de
Pedia ía
99
(2023)
195---202
o
which
he
Code
o
Conduc
o
Resea ch
In eg i y
he
All
Eu opean
Academies
(ALLEA)32 is
he
mos
salien .
As
ega ds
good
p ac ices,
we
ough
o
highligh
he
need
o
main ain
he
s ic es
policy
in
ela ion
o
he
disclo-
su e
o
con lic s
o
in e es
by
all
in ol ed
pa ies.
Con lic s
o
in e es
a e
si ua ions
in
which
he
judgmen
o
a
p o-
essional
in
ela ion
o
a
p ima y
in e es
(in eg i y)
may
be
unduly
in luenced
by
a
seconda y
in e es .
These
con-
lic s
mus
be
disclosed
and
a e
no
conside ed
misconduc
i
hey
a e
iden i ied
and
aken
in o
accoun .
The e
a e
many
ypes
o
con lic s
o
in e es ,
no
only
inancial,
and
ans-
pa ency
mus
be
exe cised.
No
only
esea che s,
bu
also
academics,
jou nal
edi o s,
e alua o s,
adminis a o s
and
commi ee
membe s
ha e
he
du y
o
disclose
hei
in e -
es s
o
he
public
so
ha
he e
a e
no
conce ns
ega ding
hei
independence
and
in eg i y.33,34
Poo
scien i ic
p ac ice
is
no
limi ed
o
he
classic
iad
o
plagia ism,
ab ica ion
and
alsi ica ion,
bu
can
a ec
any
ung
in
he
chain
o
scien i ic
ou pu .
One
example
is
he
in eg i y
o
he
membe s
o
he
edi o ial
eams
o
scien i ic
jou nals,
who
play
an
essen ial
ole
in
he
dissemina ion
and
publica ion
o
esul s.35---37
Al hough
he
unc ions
assigned
explici ly
o
RECs
con-
ce n
he
e alua ion,
along
wi h
he
subsequen
app o al
o
e usal,
o
esea ch
p oposals
and
he
moni o ing
o
he
s udies
unde way,
we
mus
no
o ge
hei
ole
in
educa ion
and
in
gua an eeing
he
scien i ic
in eg i y
o
esea ch,
as
e lec ed
by
he
Law
on
Biomedical
Resea ch.
In
his
ega d,
we
ough
o
highligh
he
wo k
o
commi ees
in
he
dissem-
ina ion
o
knowledge
ela ed
o
e hical
and
legal
aspec s
o
biomedical
esea ch
aimed
a
esea che s
wi h
he
pu pose
o
ensu ing
adhe ence
o
e hical
s anda ds
in
esea ch.
Some
p ac ical
conclusions
Any
s udy
in
human
beings
o
using
human
biological
sam-
ples
mus
be
app o ed
by
a
REC/REC-M.
This
applies
bo h
o
s udies
o
la ge
scope
o
impo ance
(clinical
ials,
obse a-
ional
d ug
s udies,
s udies
wi h
biological
samples
and/o
medical
de ices
o
p oduc s)
and
o
any
p ojec
ha
in ol es
handling
pa ien
da a,
wha e e
i s
ype,
signi icance
o
pu pose,
anging
om
s uden
heses
o
e ospec i e
obse -
a ional
s udies
in ended
o
publica ion
o
whose
esul s
a e
o
be
p esen ed
in
any
o he
o m.
P io
app o al
o
hese
s udies
by
a
commi ee
is
indis-
pensable,
as
i
gua an ees
adhe ence
o
e hical
p inciples
and
he
legal
igh s
o
pa icipan s,
in
addi ion
o
hei
me hodological
quali y
and
sa e y,
wi h
he
p emise
ha
i
a
s udy
is
no
me hodologically
co ec
i
canno
be
consid-
e ed
e hically
accep able.
Ob aining
in o med
consen
om
pa ien s
should
be
s an-
da d
p ac ice
o
any
esea ch
p ojec .
The
con iden iali y
o
pa ien
da a
mus
be
p o ec ed
h oughou
he
en i e
p ocess
and,
while
he e
a e
si ua ions
in
which
a
wai e
may
be
eques ed,
in o med
consen
is
an
essen ial
com-
ponen
o
gua an eeing
adhe ence
o
he
e hical
p inciple
o
au onomy.
In
any
case,
he
eques
o
exemp ion
om
in o med
consen
mus
be
e alua ed
by
a
REC/REC-M,
which
will
decide
on
he
ma e
a e
in es iga ing
he
pa icula
ci cums ances
o
he
s udy.
Resea ch
e hics
commi ees
and
REC-Ms
play
a
key
ole
in
he
ad ancemen
and
implemen a ion
o
e hical
and
legal
aspec s
aimed
a
gua an eeing
he
scien i ic
in eg i y
o
esea ch
by
p omo ing
alues
such
as
objec i -
i y,
independence,
impa iali y
o
anspa ency.
Heal h
ca e
p o essionals,
esea che s
and
esea ch
e hics
commi ees
mus
ensu e
ha
scien i ic
p og ess
un olds
in
adhe ence
wi h
e hical
and
legal
p inciples,
igo ously
upholding
he
igh s
o
esea ch
pa icipan s.
Con lic s
o
in e es
The
au ho s
ha e
no
con lic s
o
in e es
o
decla e.
Re e ences
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Supe io
de
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2023].
A ailable
om:
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N
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egulado a
de
la
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de
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de
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que
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au o ización
y
un-
cionamien o
de
los
biobancos
con
ines
de
in es igación
biomédica
y
del
a amien o
de
las
mues as
biológi-
cas
de
o igen
humano,
y
se
egula
el
uncionamien o
y
o ganización
del
Regis o
Nacional
de
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pa a
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Dec e o
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de
4
de
diciemb e,
po
el
que
se
eg-
ulan
los
ensayos
clínicos
con
medicamen os,
los
Comi és
de
É ica
de
la
In es igación
con
medicamen os
y
el
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Espa˜
nol
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Clínicos.
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28
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om:
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O den
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de
19
de
ene o,
po
la
que
se
pub-
lica
el
Acue do
de
la
Comisión
de
Recu sos
Humanos
del
Sis ema
Nacional
de
Salud,
po
el
que
se
ap ueba
el
p o ocolo
median e
el
que
se
de e minan
pau as
básicas
des inadas
a
asegu a
y
p o ege
el
de echo
a
la
in imi-
dad
del
pacien e
po
los
alumnos
y
esiden es
en
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de
la
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G.
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and
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Fa nós
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de
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de
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del
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de
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de
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ela i o
a
la
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de
las
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en
lo
que
espec a
al
a amien o
de
da os
pe sonales
y
a
la
lib e
ci culación
de
es os
da os
y
po
el
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de
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po
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Consejo
de
O gani-
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In e nacionales
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