CA20104 – Ne wo k on e idence-based
physical ac i i y in old age (PhysAgeNe )
Deli e able D2.1
D2.1 Compendium o legal, e hical and esou ce aspec s o open da a
eposi o ies
Con ibu o s
Wo king G oup 2
Ca l-Philipp Jansen (WG2 co-leade ), Tiia Kekäläinen (WG2 leade ), S a a
Sigu ða dó i (WG2 membe ), Alice Masini (WG2 membe ), E ja Po egijs ( o me
WG2 leade , ac i e membe )
Pa icipan s in he expe discussions and e iew g oups ha e con ibu ed o hese
esul s.
Table o Con en s
1. In oduc ion........................................................................................................................................................ 3
2. E hical conside a ions in da a sha ing........................................................................................................5
2.1. In oduc ion and key e hical p inciples................................................................................................5
2.2. In o med consen , pa icipan igh s, and da a anonymiza ion...............................................6
2.3. E hical e iew and o e sigh ..............................................................................................................7
3. Bes P ac ices and Recommenda ions.........................................................................................................8
4. Resou ce Conside a ions in Da a Sha ing..................................................................................................9
4.1. In as uc u e equi emen s, budge ing, and da a managemen .............................................9
4.2. Da a managemen cos s......................................................................................................................10
5. Conclusion.........................................................................................................................................................11
6. Re e ences.........................................................................................................................................................12
1. INTRODUCTION
In ecen imes, he p o ision o access o da a o scien i ic pu poses has gained inc easing
impo ance, bu also complexi y. Da a sha ing plays a c ucial ole in heal h esea ch by enhancing
collabo a ion, imp o ing e iciency, and os e ing inno a ion. Howe e , e ec i e da a sha ing
equi es ca e ul na iga ion o legal, e hical, and esou ce- ela ed challenges. The implemen a ion
o egula o y manda es, in e nal p ocedu es, and echnical p ocesses o enable da a p o ision is
challenging. As a esul , his ask is o en delayed and ine icien in mos p ojec s. S anda dised
p ocedu es o his ma e could os e da a sha ing p ocedu es and c ea e highe impac and
e iciency.
Da a sha ing is in eg al o mode n heal h esea ch as i enables:
G ea e collabo a ion and e iciency ac oss p ojec s.
Enhanced esea ch impac by allowing b oade analysis o la ge da ase s.
Imp o ed pa ien ou comes by le e aging sha ed da a o de elop inno a i e ea men s and
solu ions.
Howe e , da a sha ing in oduces legal, e hical echnical, and esou ce aspec s and complexi ies
ha mus be add essed.
Acco ding o Ho izon Eu ope, da a should be deposi ed as soon as possible a e i s c ea ion and no
la e han he p ojec 's comple ion. Howe e , addi ional equi emen s apply:
Da a suppo ing a scien i ic publica ion mus be deposi ed no la e han he ime o
publica ion, ollowing s anda d communi y p ac ices.
In he e en o a public eme gency, and upon eques om he g an ing au ho i y,
immedia e open access mus be p o ided. I open access excep ions apply, he da a should
s ill be made a ailable o legal en i ies ha equi e i o add ess he eme gency.
In excep ional ci cums ances, da a may be deposi ed a e he p ojec 's conclusion.
This epo is being w i en unde ho ough conside a ion o he ollowing documen s:
„Da a Sha ing Playbook“, issued by he Eu opean Fede a ion o Pha maceu ical Indus ies and
Associa ions (EFPIA), 2022;
OpenAIRE‘s guide o esea che s on „How o ind a us wo hy eposi o y o you da a“ (How o
ind a us wo hy eposi o y o you da a);
OpenAIRE’s „A Resea ch Da a Managemen Handbook – A p ime on managing you esea ch da a“
(h ps://www.openai e.eu/ dm-handbook);
2. LEGAL CONSIDERATIONS IN DATA SHARING
The con en o Chap e 2 was con ibu ed by ex e nal legal expe s who a e no a ilia ed wi h
PhysAgeNe .MM
2.1. MIn oduc ion and Pu pose o he F amewo k
Wo king G oup 2 has launched an ini ia i e, WG2, and iden i ied he need o assess he legal
amewo k o sha ing esea ch da a abou echnology-assis ed physical ac i i y o olde pe sons.
The objec i e is o de e mine he condi ions unde which esea ch da a can be openly sha ed o
use by o he esea che s wi hin he EU.
The aim is o es ablish a da a eposi o y on an exis ing pla o m whe e esea che s can sha e
ga he ed esea ch da a and access da ase s sha ed by o he esea che s. The need o sepa a ely
assess he sha ing o pseudonymized and anonymized da a has been iden i ied. Addi ionally, i has
been no ed ha he esea ch da a is likely o include heal h da a.
This amewo k desc ibes he main conside a ions o openly sha ing esea ch da a wi hin he EU.
I should be emphasized ha he amewo k does no p o ide de ailed ins uc ions, and membe
s a es pa icipa ing in he EU COST Ac ion ne wo k mus ake in o accoun he equi emen s a ising
om na ional laws in each case.
2.2. Scien i ic Resea ch Pu poses in he Con ex o he Gene al Da a
P o ec ion Regula ion (GDPR) and he T ea y on he Func ioning
o he Eu opean Union (TFEU)
The Gene al Da a P o ec ion Regula ion (GDPR) does no p ecisely de ine “scien i ic esea ch
pu poses”, bu Reci al 159 s a es ha “ he p ocessing o pe sonal da a o scien i ic esea ch pu poses
should be in e p e ed in a b oad manne including o example echnological de elopmen and
demons a ion, undamen al esea ch, applied esea ch and p i a ely unded esea ch. In addi ion, i
should ake in o accoun he Union's objec i e unde A icle 179(1) TFEU o achie ing a Eu opean
Resea ch A ea.”.
A icle 179(1) o he T ea y on he Func ioning o he Eu opean Union (TFEU) s a es ha “The Union
shall ha e he objec i e o s eng hening i s scien i ic and echnological bases by achie ing a Eu opean
esea ch a ea in which esea che s, scien i ic knowledge and echnology ci cula e eely, and
encou aging i o become mo e compe i i e, including in i s indus y, while p omo ing all he esea ch
ac i i ies deemed necessa y by i ue o o he Chap e s o he T ea ies”.
Based on he p o isions, i appea s ha he ini ia i e alls wi hin he scope o “scien i ic esea ch
pu poses”. The desc ibed esea ch can be in e p e ed as con ibu ing o he ad ancemen o
echnological de elopmen , o as ei he undamen al esea ch o applied esea ch, as ou lined in
Reci al 159 o he GDPR. Addi ionally, i should be no ed ha he scope o scien i ic esea ch is b oad
pu suan o he GDPR. F om he pe spec i e o he TFEU, he desc ibed esea ch is speci ically
in ended o p omo e EU-wide esea ch, which aligns wi h he objec i es s a ed in A icle 179(1) o
he TFEU.
Howe e , in his case, da a is being sha ed on a esea ch pla o m, a he han being used solely by
he con olle o hei own scien i ic pu poses. This equi es ha a ious obliga ions unde he
GDPR a e aken in o accoun , depending on he speci ic ci cums ances (such as oles o he
pa ies).MM
2.3. Gene al Da a P o ec ion Regula ion
Below is a high-le el lis o he equi emen s o he GDPR ha mus a leas be conside ed when
sha ing he esea ch da a in he con ex o he ini ia i e.
i. GOVERNANCE, ACCOUNTABILITY AND DATA PROTECTION BY DESIGN
Da a con olle :
Responsibili y o da a collec ion and da a sha ing: De e mine who is he da a con olle
and hus esponsible o he collec ion and sha ing o esea ch da a. I is possible ha he e
is one o se e al independen da a con olle s o join con olle ship (e.g., be ween
uni e si ies o esea ch o ganiza ions).
Collabo a ion Be ween Da a Con olle s: When da a is sha ed be ween uni e si ies o
esea ch o ganiza ions, bo h collabo a ing pa ies a e esponsible o hei espec i e da a
p ocessing ac i i ies i hey ac as da a con olle s. This en ails:
Es ablishing ag eemen s on da a p ocessing e ms (e.g., a da a ans e ag eemen o join
con olle a angemen ).
Clea ly documen ing he da a-sha ing p ocess and i s pu pose.
Rele an p o isions: A icles 4, 5, 24, 26 o he GDPR.
The ole o he pla o m adminis a o (s):
Responsibili ies and du ies: Clea ly de ine esponsibili ies and du ies o pla o m
adminis a o (s) o ensu ing secu e p ocessing and sha ing o da a.MM
Access o he da a: Moni o who has access o he da a and how i is being used.MM
Role(s) o he pla o m adminis a o (s): De ine he ole o he pla o m adminis a o
om a da a p o ec ion pe spec i e (da a con olle o da a p ocesso ). I you ans e da a o
da a p ocesso , a da a p ocessing ag eemen is equi ed (A icle 28 o he GDPR). I you ac
as a join con olle wi h o he con olle (s), you shall in a anspa en manne de e mine
you espec i e esponsibili ies (A icle 26 o he GDPR).
Rele an p o isions: A icles 4, 5, 24, 26, 28 and 32 o he GDPR.
Accoun abili y and documen a ion:
Documen a ion: Documen all da a p ocessing ac i i ies, including he sha ing o da a
among esea che s.
ROPA: Conduc a Reco d o P ocessing Ac i i ies (ROPA) whe e applicable.MM
Rele an p o isions: A icles 5, 24, 28, 30 and 32 o he GDPR.
Da a p o ec ion by design:
Suppo ing GDPR equi emen s: The pla o ms and p ocesses used o sha ing da a mus
suppo GDPR equi emen s (such as da a p o ec ion p inciples ou lined in A icle 5).MM
De elopmen phase: P ac ical measu es and echnical solu ions should be implemen ed
du ing he de elopmen phase.
Secu e access o he da a: Use pla o ms ha enable secu e access o he da a.MM
Rele an p o isions: A icles 5, 25 and 32 o he GDPR.
ii. LEGAL BASIS AND PURPOSE OF PROCESSING
G ounds o p ocessing pe sonal da a:
O iginal Legal Basis: Ensu e ha he ini ial da a collec ion is based on a law ul g ound o
p ocessing (e.g., consen o public in e es in scien i ic esea ch, A . 6(1)(e) o A . 9(2)(j)).MM
Legal Basis o Fu he Use: I he da a is sha ed o use in new esea ch pu poses, his
may equi e a new legal basis o p ocessing, unless
o he o iginal legal basis also co e s u he use o
oi can be in e p e ed ha he u he p ocessing o scien i ic esea ch pu pose is
compa ible wi h he pu pose o which he da a was ini ially collec ed (see e.g.,
Reci al 50 o he GDPR).
Rele an p o isions: A icles 6 and 9 and Reci al 50 o he GDPR.
Pu poses o da a p ocessing and pu pose limi a ion:
O iginal legal basis: The o iginal pu pose o p ocessing pe sonal da a mus be compa ible
wi h he pu pose o u he p ocessing.
Legal basis o u he use: The GDPR’s Reci al 50 acknowledges ha u he p ocessing o
pe sonal da a o scien i ic esea ch pu poses is gene ally conside ed compa ible wi h he
o iginal pu pose, i :
oThe u he use emains wi hin he limi s o scien i ic esea ch pu poses.MM
oThe u he p ocessing complies wi h he GDPR's equi emen s and includes
necessa y sa egua ds (A . 89(1)).
Con ac ual a angemen s: Ag ee in w i ing wi h o he esea che s ha he esea ch da a may
only be u he used o scien i ic esea ch pu poses.
Rele an p o isions: A icle 5(1)(b) and A icle 89(1) and Reci al 50 o he GDPR.MM
iii. DATA SECURITY AND PROCESSING SAFEGUARDS
Anonymiza ion and pseudonymiza ion:
Anonymiza ion: I he esea ch da a is ully anonymized, he GDPR does no apply (see
Reci al 26 o he GDPR). Howe e , i mus be no ed ha he concep o anonymiza ion mus
be in e p e ed s ic ly, which means ha he da a canno be es o ed o an iden i iable o m,
e en wi h he use o addi ional ools, o be conside ed anonymized.MM
Pseudonymiza ion: I he da a is pseudonymized bu indi iduals emain iden i iable, he
GDPR applies. In his case, adequa e echnical and o ganiza ional sa egua ds, pa icula ly
hose ensu ing da a minimiza ion, mus be ensu ed (A icle 89(1) o he GDPR)).MM
Rele an p o isions: A icle 89(1) and Reci als 26 and 156 o he GDPR.MM
Access con ol, e ms o use and secu i y measu es:
Access con ol: Pla o ms used o da a sha ing mus include access con ol (e.g., ole-based
pe missions).MM
Te ms o use: I da a is sha ed on open esea ch pla o ms, clea ly de ine i s e ms o use
and ensu e ha he da a emains limi ed o scien i ic pu poses.MM
Enc yp ion: Enc yp ion o da a du ing ans e and s o age mus be implemen ed.MM
Rele an p o isions: A icles 5 and 32 and Reci al 83 o he GDPR.
i . CONSENT AND RIGHTS OF DATA SUBJECTS
Consen : M
Clea and documen ed consen : Ensu e ha clea and documen ed consen has been
ob ained om pa icipan s o sha ing hei da a o esea ch pu poses, especially o
possible u he use by o he esea che s.
The scope and main equi emen s o consen : The consen mus co e da a sha ing
wi hin he EU and he speci ic pu poses o p ocessing. E en hough he scien i ic esea ch
pu pose is in e p e ed as compa ible wi h he o iginal pu pose unde he GDPR (see e.g.,
Reci al 50), consen mus be b oad enough o include da a sha ing and possible da a euse.
Consen mus be olun a y, speci ic, in o med, and unambiguous. Consen may be gi en in
w i ing, elec onically, o in ano he o m ha clea ly documen s i .MM
The wi hd awal o consen : The da a subjec shall ha e he igh o wi hd aw his o he
consen a any ime. This igh mus be communica ed clea ly o pa icipan s du ing he
consen p ocess. Fo pseudonymized o iden i iable da a, p ocedu es mus be in place o
add ess wi hd awal eques s e ec i ely. I he da a has been anonymized, wi hd awal is no
longe applicable.
Speci ic challenges in esea ch con ex s:
Iden i iable da a: When sha ing iden i iable da a, he igh o wi hd aw consen a any
ime poses p ac ical challenges, especially i he da a has al eady been sha ed o eused.MM
Anonymized da a: I he da a is anonymized, consen may no be equi ed, as anonymized
da a alls ou side he scope o he GDPR. Howe e , s ic anonymiza ion s anda ds mus be
me o ensu e ha e-iden i ica ion is no possible.
Rele an p o isions: A icles 4(11) and 7 and Reci als 32, 42, 50 o he GDPR.MM
Special ca ego ies o pe sonal da a:
Explici consen : I special ca ego ies o pe sonal da a a e p ocessed, he consen mus be
explici (GDPR, A icle 9 (2)(a)) in addi ion o he o he equi emen s o consen (GDPR,
A icle 4 (11); A icle 6(1)(a) and A icle 7).
Rele an p o isions: A icles 4, 6, 7 and 9 o he GDPR.
Righ s o he da a subjec :
Righ s o he da a subjec : Ensu e ha he igh s o he da a subjec can be exe cised (e.g.,
he igh o access, ec i y, o objec o he p ocessing o hei da a) pu suan o A icles 12-22
o he GDPR.
Excep ions o he igh s o he da a subjec : EU o membe s a e law may p o ide o
de oga ions om he igh s e e ed o in A icles 15, 16, 18 and 12 o he GDPR.MM
Rele an p o isions: A icles 12-22 and 89(2) o he GDPR.
In o ming da a subjec s:
In o ming da a subjec s: Da a subjec s mus be in o med in clea and unde s andable
manne ha hei da a is being collec ed and u he sha ed o esea ch pu poses.MM
Con en o communica ion: Communica ion should emphasize how da a is p ocessed
(desc ip ion o p ocessing ac i i ies) and wha igh s da a subjec s ha e. Addi ionally, da a
subjec s should be in o med how hei da a is p o ec ed.
Rele an p o isions: A icles 12-14, 15-22 and 32 o he GDPR.
. OPERATIONAL REQUIREMENTS
O ganiza ional equi emen s (policies, guidelines, e c.):
Guidelines: Es ablish clea o ganiza ional guidelines o policies on how da a is sha ed
esponsibly and law ully.
Documen a ion: Documen p ac ices ela ed o da a sha ing, pa icula ly among EU
esea che s.MM
Rele an p o isions: A icles 24, 25 and 89(1) o he GDPR.
Da a li ecycle:
Da a e en ion and dele ion: De ine how long he da a (including backups) will be e ained
and when i will be dele ed.
Da a dele ion: Dele ion p ac ices mus be clea and documen ed.
Excep ion o longe e en ion pe iods: Pe sonal da a may be s o ed o longe pe iods
inso a as he pe sonal da a will be p ocessed solely o , o example, scien i ic esea ch
pu poses o s a is ical pu poses in acco dance wi h A icle 89(1) subjec o implemen a ion
o he app op ia e echnical and o ganisa ional measu es.
Rele an p o isions: A icle 5 o he GDPR.
i. DATA TRANSFERS
Da a ans e s:
Con ac ual a angemen s: Use da a p o ec ion ag eemen s o o he o mal a angemen s
among esea che s i needed. Ensu e ha da a p o ec ion and da a secu i y a e
implemen ed in da a ans e s.
Sa egua ds o da a ans e s: I da a is p ocessed wi hin he EU/EEA, sa egua ds o
in e na ional da a ans e s a e no equi ed. I da a is ans e ed ou side he EU/EEA (e.g.,
he pla o m ope a o p ocesses da a in a hi d coun y), he e mus be an app op ia e
sa egua d o he ans e (e.g., S anda d Con ac ual Clauses (SCCs)).MM
Openly a ailable da a: I he da a is openly a ailable wi hou es ic ions based on
loca ion, i can be p esumed da a is ans e ed ou side EU/EEA. I he da a con ains
pe sonal da a, he Da a Con olle is obliged o assess ha i has a igh o ans e he da a
as well as o assess isks based on he ecipien ´s coun y/a ea. In cases whe e da a is openly
a ailable i migh be ha d o con ol and assess all he a eas and hei legisla ion whe e he
da a could be ans e ed. I he access o da a is es ic ed o EU/EEA and/o i is
anonymized e icien ly so ha i no longe is conside ed pe sonal da a, hese obliga ions on
da a ans e s don´ apply.
Rele an p o isions: A icles 5, 26 and 28 o he GDPR.
Thi d-pa y p ocesso s:
Con ac ual a angemen s: I hi d pa ies (e.g., pla o m adminis a o s o se ice
p o ide s) a e in ol ed in da a sha ing, ensu e in w i ing ha hey comply wi h GDPR
equi emen s.MM
ensu ing da a accessibili y o he public good. E hical amewo ks should p omo e non-
disc imina o y access o esea ch da a. Lesson lea ned om e hics e iew boa ds p o ided
impo an guidance o ongoing e iew o esea ch using pe sonal da a.
In s udies ha need app o al om e hics commi ees, he e should be in o ma ion in he esea ch
plan abou da a collec ion and use. Resea che s p o ide all necessa y in o ma ion abou he da a
use, and ha should include da a sha ing in he u u e. E hics commi es assess isks o da a
subjec s in he con ex o bene i s o science and socie y, and po en ial isks associa ed wi h da a
sha ing and open da a eposi o y is p ima ily p i acy isks ha can cause in o ma ional ha m.
Con iden iali y and da a p o ec ion a e key p inciples in esponding o such po en ial ha m and o
espec ing he p i acy o da a subjec s.
4. BEST PRACTICES AND RECOMMENDATIONS
Ea ly s akeholde in ol emen
Engage legal, e hical, and esou ce expe s ea ly in he p ojec o p e en delays.
Iden i y key decision-make s and in ol e hem in nego ia ions om he ou se .
P o ide aining on esponsible da a handling and sha ing.
Clea and s anda dized documen a ion
Use p e-app o ed empla es o ag eemen s o educe adminis a i e bu den.
Main ain de ailed da a low diag ams o cla i y p ocessing oles.
P oac i e isk mi iga ion
Add ess po en ial GDPR con lic s and IP conce ns be o e o malizing da a-sha ing
ag eemen s.
T anspa ency abou planned da a sha ing and open da a eposi o ies a he beginning o
esea ch i possible, and explic ly explain he use o da a in he consen p ocess.
Adop ing he SAFE Da a S anda d: secu i y measu es, anonymiza ion, uncionali y, and
e hical compliance – o maximize esea ch po en ial while sa ega ding p i acy.
De elop con ingency plans o handle un o eseen challenges.
P omo ing a da a-sha ing cul u e
O ganiza ions should cul i a e an in e nal cul u e ha alues da a sha ing and ecognizes
i s bene i s.
T anspa ency and mu ual ag eemen s among s akeholde s will ensu e e icien
collabo a ion.
T us wo hy Digi al Reposi o y (TDR) o da a p o ec ion o os e us and espec ing
p i acy.
Use cloud-based o decen alized s o age o scalabili y and accessibili y.
Implemen APIs o au oma ed and e icien da a exchange.
Moni o ne wo k bandwid h o p e en slowdowns o bo lenecks.
Ensu e sys em in e ope abili y o acili a e seamless in eg a ion.
5. RESOURCE CONSIDERATIONS IN DATA SHARING
E icien esou ce alloca ion ensu es ha da a-sha ing ini ia i es a e sus ainable and cos -e ec i e.
5.1. In as uc u e equi emen s, budge ing, and da a managemen
Wi h ega ds o in as uc u e and echnology equi emen s, o ganiza ions mus selec an
app op ia e da a-sha ing model:
Cen alized Model: A single eposi o y o da a s o age.
Fede a ed Model: Dis ibu ed da a access wi hou cen alizing s o age.
Hyb id Model: A mix o bo h app oaches.
S anda dized common da a models and exis ing pla o ms should be le e aged o a oid
unnecessa y duplica ion.
Wi h ega ds o budge ing and cos managemen , in as uc u e cos s o secu e da a s o age, legal
and compliance cos s (e.g., GDPR assessmen s, legal counsel), and pe sonnel cos s o da a
go e nance and secu i y managemen mus be conside ed.
De eloping a Da a Managemen Plan (DMP) ensu es cla i y on da a-sha ing wo k lows. Wi hin his
ask, oles should be assigned o da a go e nance o e sigh (e.g., Da a P o ec ion O ice s), legal
compliance (e.g., con ac manage s), and IT and secu i y (e.g., cybe secu i y expe s).
Acco ding o he Resea ch Da a Managemen Handbook, a DMP b ie ly de ines:
how he da a will be c ea ed;
how i will be documen ed;
who will be able o access i ;
whe e i will be s o ed;
who will back i up;
whe he (and how) i will be sha ed and p ese ed.
Da a-sha ing ini ia i es mus adhe e o ecognized secu i y s anda ds o mi iga e isks. The e o e,
o ganiza ions should implemen access con ol mechanisms (e.g., ole-based access), enc yp ion
echniques o da a ansmission, and audi ails o moni o da a access and compliance.
Long- e m da a sus ainabili y s a egies should be embedded in p ojec planning, whe eas public-
p i a e collabo a ion can enhance esou ce a ailabili y and long- e m da a access.
5.2. Da a managemen cos s
P ope planning o da a managemen and sha ing is essen ial, as hese ac i i ies equi e bo h ime
and esou ces. Ea ly planning can help minimize cos s. Expenses ela ed o open access o
esea ch da a can be conside ed eligible cos s, o example unde a Ho izon 2020 g an , p o ided
hey mee he condi ions ou lined in he espec i e G an Ag eemen . Gene ally, his means hey
mus be budge ed in ad ance and app o ed in he g an p oposal, and hey can only be claimed
du ing he p ojec 's du a ion.
As an example, unde h ps://www.openai e.eu/how- o-comply- o-h2020-manda es- dm-cos s a ool
is p o ided o es ima e cos s o eseac h da a managemen . A ou -s ep app oach is ad ised (see
link abo e):
“S ep 1:MCheck he da a managemen ac i i ies in he able and ick hose ha may apply o you
p oposed esea ch.
S ep 2:MFo each selec ed ac i i y, es ima e he addi ional ime and/o o he esou ces needed and
cos his, e.g. people’s ime o physical esou ces needed such as ha dwa e o so wa e. Find ou
which esou ces, e.g. o da a s o age and backup, a e a ailable o you om you ins i u ion.
Conside whe he you need a dedica ed da a manage .
S ep 3:MAdd hese da a managemen cos s o you esea ch applica ion. Coo dina e esou cing and
cos ing wi h you ins i u ion, esea ch o ice and ins i u ional IT se ices.
S ep 4:MPlan he da a managemen ac i i ies in ad ance o a oid hem compe ing wi h he need o
ocus on esea ch excellence.“
6. CONCLUSION
Legal, e hical, and esou ce- ela ed conside a ions a e undamen al o success ul da a sha ing. By
es ablishing clea legal amewo ks, ensu ing e hical compliance, and op imizing esou ces,
o ganiza ions can c ea e obus , sus ainable, and impac ul da a-sha ing ini ia i es. P oac i e
planning and adhe ence o bes p ac ices will acili a e seamless collabo a ion, enhance esea ch
impac , and os e us among s akeholde s.
7. REFERENCES
„Da a Sha ing Playbook“, issued by he Eu opean Fede a ion o Pha maceu ical Indus ies and
Associa ions (EFPIA), 2022.
OpenAIRE‘s guide o esea che s on „How o ind a us wo hy eposi o y o you da a“ (How
o ind a us wo hy eposi o y o you da a).
OpenAIRE‘s guide o esea che s on „How o iden i y and assess Resea ch Da a Managemen
(RDM) cos s“ (h ps://www.openai e.eu/how- o-comply- o-h2020-manda es- dm-cos s).
OpenAIRE’s „A Resea ch Da a Managemen Handbook – A p ime on managing you esea ch
da a“ (h ps://www.openai e.eu/ dm-handbook).
E hics and da a p o ec ion, p. 11:
h ps://ec.eu opa.eu/in o/ unding- ende s/oppo uni ies/docs/2021-2027/ho izon/guidance/e hics-
and-da a-p o ec ion_he_en.pd
Open science: h ps:// ea.ec.eu opa.eu/open-science_en
E hics and da a p o ec ion, p. 11:
h ps://ec.eu opa.eu/in o/ unding- ende s/oppo uni ies/docs/2021-2027/ho izon/guidance/e hics-
and-da a-p o ec ion_he_en.pd
E hics and da a p o ec ion, p. 12:
h ps://ec.eu opa.eu/in o/ unding- ende s/oppo uni ies/docs/2021-2027/ho izon/guidance/e hics-
and-da a-p o ec ion_he_en.pd
E hics and da a p o ec ion, p. 11:
h ps://ec.eu opa.eu/in o/ unding- ende s/oppo uni ies/docs/2021-2027/ho izon/guidance/e hics-
and-da a-p o ec ion_he_en.pd
E hics and da a p o ec ion, p. 12:
h ps://ec.eu opa.eu/in o/ unding- ende s/oppo uni ies/docs/2021-2027/ho izon/guidance/e hics-
and-da a-p o ec ion_he_en.pd
