Biobanks as a resource

8/13/2019 Biobanks as a resource

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Biobanksas resources for healthMats G. Hansson & Marianne Levin (eds.)


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j~ dK e~Marianne Levin

(Eds.)

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o~ m~ b _


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fp_k VNJRMSJNSRVJS

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`1. Biobanks as resources for health V

j~ dK e~ C j~~ i

NK f V OK _~ ~ NO PK ^ ~ ~ ~ ~ ~

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2. Clinical data a necessary requirement for realising the potential of

biobanksON

_ p iNK f ON

OK _~ `~ m~ OO PK _~ ~ ~~~ ~ OP QK t~ ~ ~ \ OQ RK b~ ~ ~ ~ ~ ~ ~~ OS

SK m~~J PM TK d ~ PM UK t~ ~ ~\ PM

3. Examples from Swedish biobank research PPj~ h~

NK f PP OK ` p ~ ~~ PP PK b~ PQ

4. Clinical genomics companies and biobanks The use of biosamplesin commercial research on the genetics of common diseases RN

g i~~Je~NK f RN

OK q ~ ~W ~ RO PK q ~ ~W ~ RT QK q SO RK ` d SO SK l~ SR TK r~d SU UK `~~ ~~ TM VK ` ~ UT


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5. Public law aspects on the use of biobank samples

Privacy versus the interests of researchVN

b~ oNK f VN

OK p ~ VO

PK o ~ VS QK e~ ~ ~~ ~ ~ ~ ~~ VV RK m~ ~ ~ ~ ~~ NMP SK r p ~ ~~ ~ NMR TK ` NNR UK ` ~ NON

6. Focusing on personal integrity violation legal guidelines for ethical

practiceNOV

r bNK f NOV OK q b~ o ^ NPM

PK ^ ~ ~~ NPS QK o _~ o~ b NQM

7. A Swedish standard for information and consent procedures in

biobank researchNQV

d eN f NQV

OK _~ ~ ~ ~ NQV PK f NRN

QK s~ ~ ~ NRO RK d~ ~ ~ NRP SK ` NRR TK a NRV

8. Mapping the debate on informed consent NSR p~ b

NK f NSR OK p ~ ~ _~ ^ NSS PK p ~ ~ NTO

9. Public and patient perception of biobanks and informed consent NVT

i~ o C ~ h i~NK f NVT

OK b~ ~ ~ ~ ~~ ~ ~ ~~ ~ ~ ~~

NVU

PK q p ~ ~ ~ ~

OMN


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10. Intellectual property and biobanks OMT~ e~I p~~ t C o~ t~

NK f OMT OK q ~I ~ ~ ~ OMV PK b ~ ONO

QK t ~\ OOM RK p~ OOP

11. Gifts and donations OOT^~ e mNK d ~ ~ OOT

OK q OOU PK t ~ ~ ~ ~~ OPM QK t ~ ~ ~~\ OPP RK d OPQ

SK l OPS TK a~ OPV UK l ~ OQO VK `~ ~ ~ OQO NMK ^ ~~ ~~ ~ OQP NNK j~ ~ OQR NOK o ~ OQS NPK ` OQU

12. Commercial engagement and public research in the biomedical area ORR r~ _~13. Agreements concerning human biological material ORT

r~ m~ C o~ cNK _~ ORT

OK d~ ~ ~ ~ ORT PK h ~ OSM QK ` OST

14. Publications and activities OSV NK m OSV

OK p ~ OTM PK m~ L OTN QK ` ~ ~ OTN RK m ~ OTS


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_~ ~ ~

N

Biobanks as resources for health

^~ m j~ dK e~NC m j~~ iO

1o~ m~ b _I r~~ r2a~ i~I p r

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1. Introduction

q ~ ~ ~ ~I ~ ~ ~~ ~ ~ ~K s~ p ~ ~~ ~ ~ ~ ~ ~ K q ~ ~~ ~ K b~ ~ ~ ~K ^ ~ ~ ~ ~ I ~ ~ ~ ~ ~ ~ ~ ~ ~ ~K q ~ I ~ ~ ~ J~K f NVVU sJ`~ r~~

r ~ ~ ~ b _o~ m~ ~ ~ ~~ ~ ~I ~~ ~K m ~ ~ ~ ~~ ~I ~ ~ ~ ~ ~ ~ ~ ~ ~K f ~ ~I~ ~ ~ ~ I ~ ~ ~~ ~ ~~ I~ ~ ~ ~~ ~ ~ ~ ~ ~ ~~ ~ ~I

~K q ~ ~K ^ ~~ ~ ~~ ~ ~K

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j~ dK e~ C j~~ i

q ~ ~ b _o~ m~ ~ ~~ ~ J ~ ~I ~ r~~ r ~ ~ K qa~ i~ ~ p r ~ ~ ~ ~~

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^~ m j~ dK e~I _K^KI qaI Em i~FI o~m~ b _I r~~ rK

m j~~ ^I maI ^~w~ ^_K

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d eI maI o~ m~ b _I r~~rK

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i~ gI maI ^~ _K

j~ h~I maI a~ j~ bI h~~fK

~ hJi~I maI a~ m~~I r~~ rK

Nc ~ ~ W e~I jKdKI EKFI q r e~ _~K b~I p~Ib~ ~ i~ ^I o NI r~~ r OMMNI fp_k VNJRMSJNQTOJuI VP K

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_~ ~ ~

^~ m g i~~Je~I maI f j~~ f~ ~ qI `~ r qI dK

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^~ m h t~I j~ m ^I r~~

p~~ tI a~ ~~I iijI a~ i~I prK

^ ~ ~ ~ I ~ ~ ~ ~~ K p ~

OMMPK q ~ ~ K q ~ ~ J~ ~ ~ ~ ~ ~~ ~ ~ ~ ~K q~ ~ ~ ~ pc~ ` ` g~~ OMMP ~ ~ ~ p ~ ~ ~ ~ ~ ~ ~ ~ ~ K p~ ~ K q ~ ~~ ~~ ~ ~~ ~ ~ ~ ~ ~ ~~~ ~ ~ ~K q br a EOMMNLUPLb`F ~~ ~ ~ ~ I I I ~ ~

~ ~ ~ ~ ~~~ ~ b~ r

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j~ dK e~ C j~~ i

~ ~K ^ ~ ~~ q b~^ b~~ j~ m Ebjb^FI aOMMO Ebjb^LLPMTMLMNF ~~ ~~ ~ ~ ~ ~K l ~ ~ ~ ~ b~ ~ ~

~ ~ br a EOMMOLMNOUE`laF ~~ ~ ~ ~ ~I I II ~ ~ ~ ~ K

2. Biobanking is not a new phenomenon

f ~ ~ ~ ~ ~~ ~ ~K p ~ ~ ~ N g~~ OMMP ~ ~ ~ K e~ ~

~I ~ ~ ~ ~ ~ ~K f ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~Kc ~ ~ ~I ~ ~ Kf ~ ~ ~~ ~ ~K _ i ~ ~ EK OF ~ ~ ~ ~~ ~ ~K f ~ ~ ~ ~ ~ ~ ~ ~I ~ ~ ~ ~~ ~ ~ ~K p ~ ~ ~ ~K f ~ ~ ~~ ~ ~ ~ ~ ~ ~~ ~ J~ ~ I ~ ~ ~~ ~ ~ J~K q ~I ~ p ~ ~~I ~ ~ K

eI ~ ~ ~ ~~I ~ ~ ~ ~ I KK ~I ~ ~ ~ ~ ~ ~K f I ~ ~ ~~K i ~ ~ J~~ ~ ~~~ ~~ ~ ~ ~ ~K o~ ~ ~~I

~ ~ ~~ ~ ~ I ~ ~~ ~ ~~ ~I ~ ~ ~ ~ ~K o~ ~ ~ ~ ~ ~ ~ ~ ~ ~K t ~ ~ ~ ~ ~ ~~ ~ ~J~~ ~ ~ ~ ~ ~ ~J ~K ^ J~~ ~ ~ ~~~ ~ ~ ~ ~ ~ ~~~ ~K d ~ ~ ~

~~ ~ ~ ~ ~ ~ J ~ J K

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3. A great variety of research projects for realising the potential of biobanks

q ~ ~ ~ ~ ~ I ~ ~ ~ ~ ~ ~ ~ ~ ~ ~

~ ~K j~ h~ EK PF ~ ~ ~~ ~ EF ~~ ~I EF ~~ ~ ~ ~ IEF ~~ ~ ~ ~~ ~ ~ ~ ~ EF ~~ ~K t~ ~ I ~ ~ ~ ~~ ~ ~K h~ ~ ~ ~ ~ K e ~ ~ ~ ~ ~ ~ ~ ~ ~K b~ ~ ~ ~I ~I

~ ~ ~ ~K l ~ ~ ~ ~ ~I ~~ ~ ~ ~ ~ ~ ~~~K q ~ ~ ~ ~ ~~~ ~ I~ ~ ~~ ~ ~ ~ ~ ~ ~~ ~ ~~~ ~ ~~~K l ~I ~ ~I ~ ~ ~ ~ ~ ~ ~ ~ I~ ~ ~ K

p ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ K p ~ ~I ~ ~ ~ ~ J ~K q ~ ~ ~ ~ ~ ~K q ~~ ~ J ~ ~ ~ ~ K _ OMJQMB ~ I ~ ~ ~ K f ~ ~~ K f ~ ~ ~ ~~ ~~ I

~ ~ ~ ~ ~ ~K _ ~ ~ ~ ~ ~ ~ I ~ ~ ~ ~~~ K e ~~ ~ ~~ J~ ~ ~ ~ p _~ ^ ~ ~ ~ KOq _~ ^ ~ ~ ~~ ~ ~ ~ ~ ~ ~ ~ _~ ^ ~ ~ ~ K eI ~ r b EK SF ~

Op ~ e~I jKdI _~~ ~ I g~ j~ bI ~ e~IjKdI ` ~ ~ ~ ~I K

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d e EK TFI ~ p ~ ~ ~ ~ ~ ~ Ed _ OMMOLMPWRMFKq ~ ~ g~~ OMMQK

4. Partnership for the benefit of patients

f ~ ~ ~ ~ ~~ ~ ~~ ~~ ~ ~ ~ ~ ~ I ~ ~ ~ ~~K a ~ ~ ~ ~ ~ ~~ ~ ~ ~ ~ ~ ~K a ~ ~~ ~ ~ ~ ~ ~ ~ K `~ ~ ~~~ ~ ~ ~ ~ ~ K

p ~ ~ ~K `~~ ~ ~ I ~ ~K f ~ ~ ~ ~ ~ ~ ~~ ~ ~ ~ ~ K t ~ ~ ~ ~ ~ ~ ~~~ ~~ ~ ~ ~J~~ ~ ~~ ~ ~ K a ~~ ~ ~ ~~ ~ ~~ ~ ~ ~K ^ ~~~ ~~ ~ ~ ~ ~K g i~~Je~ ~ ~~ W ` d f~I l~ rh~ r~d p EK QFK l ~ ~ ~ ~ ~~ ~ ~ ~ K q ~~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~I ~ ~ ~ K i~~Je~ ~ ~ ~ ~~ ~ ~ ~ ~ ~ ~ ~ K ^ ~ p ~ r ~ ~ ~ ~ ~ ~ ~ ~ ~

~ K q ~ r~ m~ ~ o~ cEK NPFK l~ ~ ~ ~~ I ~ ~ ~ ~ ~~~ ~ ~~ ~ ~ I ~~ ~ ~ K q ~ ~ ~ ~ ~K qr ~ ~ ~ ~K t ~ ~ ~ ~ I _~ ^ ~ ~ ~ ~ ~ ~ ~ K eI p ~ ~ ~ ~ ~ ~~K f ~ ~

~ ~~ ~ ~ _~ ^K

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5. Swedish law recognises both research interests and the interests of integrity

b~ o ~ ~ ~ EK RF ~ ~ ~ ~ ~ ~~ ~ ~ ~~~ ~ ~ ~ ~ ~~ ~ ~

K b ~ ~ ~K o ~ ~ ~ ~ ~~ ~ ~ ~K m ~ ~ ~ ~ J ~ K q ~~ ~ ~ ~ _~ ^ ~ ~ ~Ko ~ ~ ~ ~ ~ ~ ~~ ~K p ~ ~ ~ ^ I ~ ~ I ~ _~ ^

~ ~ ~ ~K k~ ~ ~ ~ ~K q ~ ~ ~ ~I ~ ~ ~ ~ ~K eI~ ~ ~ ~ ~ ~ ~ ~~I ~ ~~ ~ ~ ~ ~~ ~ ~ ~ ~ ~ ~ ~ ~ K q ~ ~ K

6. The new legislation opens the way to pragmatic solutions and minimises therisk of arbitrariness

q ~ ~ ~ ~ ~ ~ ~ ~~ K f ~I ~~ ~ ~I ~~ ~ ~ ~ ~I _~ ^ ~ ~ ~ ~~ ~K q ~~~ ~ ~~ ~ ~ K l ~ ~ ~ ~ ~ ~ ~K q ~ ~ ~ ~ ~~I KK ~ ~ ~ ~

~I ~ ~~ ~K eI ~ ~ ~ ~ ~ Kt ~ ~ ~ ~ ~

~~ ~ ~ I ~ ~ ~ ~ ~ K e ~ ~ ~~ ~ ~ ~~ ~ ~~ ~ ~ K p~b EK UF ~ ~ ~ p ~ ~ ~ ~ ~ ~ ~ ~~ ~~ ~ ~ ~ K m~ I ~~ ~ ~ ~ ~ ~ ~ ~ ~ K c ~~ ~ ~ b ~K c ~ I ~

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I ~ ~ ~ ~ ~ ~ ~K f ~ ~ ~~ ~ ~K eI _~ ^ ~ ~ I ~~K ^

r b ~ ~ ~ ~ EKSFI b~ o ^ Ed _ OMMOLMPWRMF ~~ _~ o~ b ~ ~ ~ ~ ~ ~K

l ~ ~ ~ NVVS b~ ` _ ~ e~ oK ^ ~ ~~ ~~ b~o Î ~ ~ ~ ~K ^ OO ~ ~W t ~ ~ ~ ~~ I ~ ~ ~ ~ ~ ~ I ~~

~ ~ K q ~I I ~ ~~~~ ~ \ p ~ ~~ ~~ Ì ~ ÔO E NPTFW q ~ ~ ~~ ~ ~ ~ ~I ~ ~~ ~ ~~ K qII I I ~~ ~ K f ~I ~~ ~I ~ E ~I ~ ~ ~ ~ ~FI K f ~I ~ ~ ~ I ~ ~I ~~ ~ ~ ~ ~K

q ~~ ^ OO ~~ ~ ~ ~K r b ~ ~ ~ ~I ~ ~ ~~ `K q ~ b~ o ^ ~ ~~ ~ ~ ~ ~ ~I ~ ~ ~ ~~ ~K q _~ o~ b ~ ~~~ ~ I ~~I ~ ~~ ~ ~

~ ~~K o~ ~ ~ ~~I ~ ~ ~ ~ ~K q ~ ~ ~I ~ ~ ~ ~ I ~KeI ~ b I ~ ~ ~ ~ ~ ~ I _~ o~ b ~ ~ ~~ ~ ~~K t I ~ ~ ~~ ~ ~ ~ ~ ~ ~ ~I KK ~ I ~ ~ ~ ~ ~K q ~ ~ ~ ~

~~ ~ ~ ~ ~~ ~ ~~ ~ K

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7. A Swedish standard for information and consent procedures

q ~ ~ ~ ~~I ~ ~ ~~ ~ ~ ~ ~ ~

~ ~ ~I I ~I ~ ~ ~ K f~~ ~ ~ ~ ~ ~~ ~ K ^ ~ ~ I ~ ~ ~ ~ ~ ~ ~ ~ ~~ ~ ~~ ~ ~~ K i~ o ~ ~ hi~ ~ ~ I ~ ~ ~ ~ SIMMM ~ ~ ~ OIMMM ~~ EK VFK f ~ UV B ~ ~ ~ ~ ~ ~ ~ ~

~ ~ ~ ~ ~ ~K t ~ ~ b~ o ^ I ~~ ~ ~ ~~ ~ ~ K

t ~ ~ ~ ~ k ~I J ~ ~ K q ~ ~ ~ ~ ~K f ~ ~ ~ ~~ ~ ~J ~ J ~ K ^ ~ ~ ~ ~ ~ ~ ~ ~ I ~ ~ ~ ~ ~~ K t ~ I ~ ~ ~ ~ ~ JI ~ ~ ~~K t ~ ~ ~ ~ J~~ ~ ~ K m ~ ~ K oJ ~ ~ KP

t ~ ~ ~ ~ ~~I ~ ~ ~ ~ ~ ~ ~~ ~ ~K f ~ I J ~ ~K de EK TF ~ ~ ~ ~ ~ ~

~ K e ~ p ~~ ~ ~ ~ ~ ~~~ ~ ~ ~ ~ ~K q W EF ~ ~ ~ ~ ~ E ~ ~FIEF ~ ~ ~ I KK q~ ~~ fscJ~IE FI EF ~ ~ ~ E F ~ EF ~ ~ E FK f ~ ~ ~ ~

~ ~ K f ~ ~ ~PfK

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~ ~ ~ ~ ~ _~ o~b ~ ~ ~ K e~ ~ ~ ~ ~ p p ^ ~ ~ ~~ ~ ~ ~ ~~ ~~ J ~~ ~ ~K

8. The importance of agreements on disposition both over the biobanks and

biological material

f ~ ~ ~ ~ ~~ ~ ~ K q ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~ ~I ~K q ~ ~ K q ~

~ K q ~ ~ ~ ~ ~ ~ ~ ~ d ^I ~ ~ I ~ q~~ p ^K q q~~ p^ ~ ~ ~ ~ ~~ ~ K eI ^ ~ ~ ~ ~ K qd ^ ~ ~ ~ ~ I ~^~ eK m EK NNF ~ ~ ~ ~ ~ ~ ~ ~~ ~ ~ q~~ p ^ ~ ~K f

~ ~ ~ ~ ~ ~ ~ ~ ~ ~ I ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~\ q ~ ~ ~ d ^ ~ ~ ~ I K ~ ~~ ~ ~ ~ ~~K k~ ~ ~ ~ ~ ~ ~ ~ ~~~ ~ I ~ ~I ~ ~ ~ ~ ~ ~ K k ~ ~ ~ ~ ~ ~~ ~ ~ ~ ~~K q J ~ d ^ ~

~ ~ ~ ~ ~ ~ ~~Kq ~ ~ ~ ~ ~ I ~ ~ ~ ~ ~ ~Kt ~ ~ ~ ~ ~~~I ~ ~ ~ ~ I _~ ^ ~ ~~ ~ ~ ~K c ~ ~ ~~I ~ ~~ ~ ~ ~~~ ~ ~K _ ~~ ~ ~ ~ ~ ~I ~W q~~ p ^ ~ _~ ^ ~ ~ ~ ~

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_~ ~ ~

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~ ~I ~ ~ ~ ~K q ~I ~~I ~ ~ ~ ~ ~ I ~ ~ ~I ~ ~ ~ ~ ~ ~ ~K _ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~ ~K

^ ~ ~ ~I ~ ~ ~ ~ ~K l ~

~ ~ r~ d ~ ~ rr ~ r ` `K t ~ ~ ~ ~ ~ K q ~ ~ ~ ~ I ~ ~ ~ ~ ~ ~~ Epr~ _~ ~ K NOFK ^ ~ ~ ~ ~~ ~ I ~ ~ ~ ~K f ~ I ~ ~ ~~ ~ ~I KK ~~~K eI ~ ~ ~~ I K q ~ ~~ ~ ~ ~ ~ ~I ~I~ ~ I ~ ~ ~ ~ ~ ~K q ~ ~ ~ ~ ~~ ~ ~ ~ ~ ~ ~ EK NMF ~e~I o~ t~ ~ p~~ tK k ~ ~ ~ ~ p I ~ ~ J~ q~ bI ~ ~K f ~ ~ ~ ~ ~~I ~ ~ ~ ~~ E I KF ~ ~K

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References

e~I jKdKI ENVVUF _~~ n~ `I g~ j~ bI sK OQIk PI g NVVUI NUOJNUTK

e~I jKdKI EOMMOF ` ~ ~ ~ ~I aK OMMO

e~I jKdKI EbKFI EOMMNF q r e~ _~K b~I p~I b~ ~i~ ^I o NI r~~ r OMMNI fp_k VNJRMSJNQTOJuI VP ~K

o OMMOLMPWRM ~ ~ ~ EOMMOF pK

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O

Clinical data a necessary requirement for

realising the potential of biobanks

_ p iI jaI maI ~

^~~ Er~~ r e~F

^~ ~ ~ ~ ~ ~

I ~ ~ ~ ~ ~K _~ ~~ ~ ~~ ~ ~ ~ ~ ~ K o~ ~ ~~ ~ ~~ ~ ~ I ~ ~ ~~ ~ ~~~ ~ ~ ~ ~K ^ ~ ~ ~ J~ ~~~ ~ K q ~ ~ ~ ~ ~ ~ ~ ~ ~K

1. Introduction

o NV ~ ~ ~ ~ ~ ~ ~ ~ ~~ W I I ~ ~ K l I d~ ~ o sNI ~ ~ ~~ ~ ~ NURUK

s ~ ~ ~ ~ ~ I ~ ~ ~ ~~ ~ K sI ~ ~I ~ ~ ~ ~ ~ ~~K m~ I ~~ ~ I ~ ~K

c ~ ~ ~ ~ ~ ~ s ~ ~ NV K q ~ ~ akÔ ~ ~ ~ ~ ~ K c ~ ~t~ ~ ` akÎ ~ ~K q ~ ~ ~ ~ ~I ~ ~ ~ ~ K

NsI oK NURUKOt~I gKI Ì cK NVRP

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2. Biobanks in clinical praxis

_~ ~ ~ ~ ~ ~ ~ K

2.1 Bloodp NVMNI h~ i~ ^_l IP~ ~ ~ ~ ~~Kl ~ ~ ~I ~ ~ ~ ~ ~~I ~ ~ ~~ ~ ~K m~ ~ ~ K p ~ ~ ~ ~K c ~~I ~~ ~K f ~ ~I ~ ~ I ~ ~ ~~ J~I ~ ~ ~ ~K

_ ~ ~ ~ K i~~E s NUQRF ~ ~ ~ ~~K q q~ oI ~~ ~ ~ pI ~ ~ NVVOK q ~ ~ ~ ~ JLei^J ~ K p ~I ~ PMM q~ o ~ ~ ~ ~ ~~~ K

iJ ~E[NR ~F ~ ~ ~ ~ ~K p ~ ~ ~ K k ~ ~ ~ ~ ~ ~K

^~ ~J~ ~ ~ ~ ~ ~ ~ ~J ~~ ~ ~~ I ~ ~K l ~ ~ ~I KK ~ ~J~~ ~ ~J~ ~I ~ ~Kp~ J~~ ~ ~~ ~ ~ ~ ~ ~K p~ ~ ~ ~ ~~ ~K

^ ~ ~ ~ ~ ~ K p~~ ~ ~ ~~ ~ fd ~~ ~ K q ~

~ ~ ~~ I ~ ~ ~~ ~ ~ K f ~ ~ ~ ~ ~ ~~ ~~~ K f ~~ ~ ~ ~ ~~ ~ ~K

2. 2 Other tissues

f ~ ~ ~ ~ ~ ~ ~ ~K _ ~~ ~ s K ^~ ~ ~ I ~ ~

Pi~I hK NVMN

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~ ~ ~ K q ~ ~ ~ ~ ~W ~ ~ ~ ~ ~ ~~ ~ ~ ~ I ~ ~ ~~K k ~ ~ ~ ~K

^ ~ ~ ~ ~ ~ ~ K f

~ ~ ~ ~ ~ ~K q ~ ~ ~ ~K q ~ K

t ak^ ~ ~ ~ ~~~I ~ ~ ~ ~ ~ K

3. Basic science and translational research3.1 Genomic and proteomic studies in the diagnostics of diseases

j~ ~ ~ ~ ~I ~ ~ ~ ~ ~ ~ ~Kt ~ ~ ~~ ~ ~ ~~I ~ ~ ~ K q ~ ~~ ~~ ~ ~ ~K d~ ~ ~ ~ ~K ` ~ ~ ~ ~ ~ ~ K c~ ~ I ~ ~ ~ ~ ~K f ~ I ~ ~ ~ ~ ~K p ~ I ~L K q ~

ak^ ~~J~ I ~ ~ ~ ~ ~~K

d ~ ~ ~ ~ ~ ~ ~ ~ ~I ~~ ~ ~K f~ ~ ~ E~~ ~~ F W

c ak^ K

a ~ EFK` ~ ~ ~

K

3.2 Translational research

q~~~ ~ ~ ~ ~ ~ ~ ~ ~ K ^ ~ ~ ~ ~~ ~ ~I ~ ~~ ~~ ~ ~ ~ K q~~ ~~ ~ ~ ~ ~~ ~~K d ~ ~ I ~ ~ ~~ ~K o~ ~ ~~ ~ ~ ~ ~ ~ ~K

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3.3 Clinical trials

^ ~ ~ ~ ~ ~ ~ ~~K `~ ~ ~ ~ ~ ~K m~ f ~~~ ~ ~X ~I m~ ff ~ ~ ~ ~ X ~ m~ fff ~ ~ I

~~ ~I ~K f ~ ~I ~ ~ ~ ~ K

4. What kind of clinical information is needed?

q ~ ~ ~ ~ ~ ~ ~ ~ ~K t~ ~ ~ ~ I ~I~ ~ ~I ~ ~ ~ ~~K d ~ ~ ~I ~

JK q~ ~ ~~ ~ ~ ~ ~ ~ ~ J ~K

q ~ ~ ~ ~ K l ~I ~~ ~ ~ ~ ~ ~I ~ ~ ~~ ~ ~ ~K q ~ ~ ~~I ~ ~~ ~ ~ K q W

4.1 Case history

^ ~ ~ ~ ~ ~ ~ ~~I ~ ~~ ~ ~ ~ ~K eI ~ ~ ~ ~ ~ ~I ~ ~ ~ ~ ~ ~~~K t ~ ~~ ~ ~I ~~ ~ ~ ~~K q ~ ~ ~ ~I ~ ~ I ~ ~ W

c~ ~ ~Km ~I K K ~ _ ~ ` ~ Ka ~ ~ ~ ~ QX ~ ~ ~~~

~ ~~K ^ ~ ~ ~ ~ ~ ~W I I ~ ~ ~K q ~ ~ ~ ~ ~ ~ ~ ~~K ^ ~ ~ ~ ~ ~ ~ J~ ~~ ~ ~K q ~ ~ ~ ~ ~ ~J~~ ~K p~ ~ ~ ~ ~I ~~ ~ Kp ~ ~ ~ ~ ~ ~K

Q`I gKeKI _~I pK^K NVVUK

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`~ ~~ ~ ~ ~ ~ ~

^ ~ ~ ~ ~ ~I ~ ~ ~I ~ ~ ~ ~ ~K p~ ~ ~ ~ ~K

^ ~ ~ JK l ~

~ ~ ~ ~ ~J~~ ~ ~ ~~ ~ E_jfF ~ ~ ~ ~ ~ ~ K _jf ~ ~ ELOFK f~ _jf NV ~ ORK r~ ~ ~ KK K l ~ ~_jf OR ~ OVIV ~ ~ PM LOKm~ ~ ~ ~J~~ ~ ~ ~Ka ~ E FK ^ ~ ~ ~~ ~ ~~ ~ ~ ~ ~ K p~ ~ ~ ~ ~ K m~~

~ ~ ~ K q ~~ ~ K ^ ~ ~ I ~ ~ ~K ` ~ ~ ~ ~ ~Kj~ ~ K ^ ~~ ~ ~ ~ ~~J ~Ke~ K ^ ~ ~ I ~~ ~ ~ ~K p ~ ~~~ ~ ~K f ~ I ~ ~~ ~ ~ ~K f ~ ~ ~ ~ ~ ~~ ~ ~ ~ K

4.2 Laboratory investigations

f ~ ~~ ~I ~ ~ VRB K^I RB ~ ~ ~~ ~ ~ ~K q ~ ~ ~ ~ ~K q ~ ~ ~~I ~ ~~ ~K

4.3 Uniform terminologyt ~ I ~ ~I ~~ ~K q ~ ~ ~ ~ ~ ~ ~K

4.4 Computerised medical recordsf ~~ ~ ~ ~I ~~I ~ ~ ~~K f ~ ~ ~~~~~I ~ ~ I ~~ ~ ~K r I ~ ~ ~ K ` ~ ~~~ ~J~~ ~K ` ~ ~ ~

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I ~~ ~ ~ ~ ~K p ~ ~ OM ~~ K q ~~ ~ ~ K q ~ ~ ~ ~ ~ ~ ~ ~ ~K

t ~ ~ ~ ~ I

~ ~ J~ ~ ~ ~ ~ ~~ ~ K f ~I ~ K

5. Examples of diseases and the need for clinical and related data

j~ ~ ~ I ~ ~~ ~ Kq ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~ ~K f

~ ~ ~ ~~ ~ ~~ K

5.1 Breast cancer

_~ ~ ~ ~~ ~ ~J ~K q ~ ~ ~ ~ ~ ~ ~ K q ~ ~ ~~JI ~J ~ J ~W

k ~ ~K

o~ ~ ~ ~ ~K

_~ ~ ~ ~K^ ~ ~ ~Km ~~L~ ~ ~Km ~~ ~Kk E~FKr K

f~ ~ ~ ~ ~ ~ ~ K f ~ ~ K q ~ ~ ~ ~

~J ~ ~ ~ ~ K

5.2 Cardiovascular disorders`~~~ ~ ~ ~ ~ ~ I ~I~ ~I ~ ~ I ~ ~ ~ ~ K f ~ ~I ~ K f ~ ~ ~ ~ ~~~~I ~ ~ ~ ~ K q ~ ~ ~ ~ W

q ~ Kq ~ ~ Kq ~K

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`~ ~~ ~ ~ ~ ~ ~

^ ~ ~ ~ E ~ ~ ~FKq ~ K

5.3 Metabolic disorders

j~ ~ ~ ~ ~ ~J~~ ~Km ~ ~ ~ ~ K

5.3.1 Diabetes

5.3.1.1 Diabetes type I (juvenile onset diabetes)q ~ W

c~ K f ~ fI ~ ~ ~ ~I~ ~ ~ ~ ~ ~I ~ ~ ~K

m K q f ~ ~~ ~ ~ KaK p ~ ~ ~I ~ ~I ~ ~ ~ iJ~~~~I ~ ~KaK f ~ ~ ~ ~ ~ ~ f ~I ~ ~J ~K q~ ~ ~ ~~ K a ~ ~ ~ ~~ ~I ~ ~ ~ I ~ ~K

5.3.1.2 Diabetes type II

a~ ff ~ ~ ~ ~

J ~K f ~ I ~ ~ ~ W

c~ ~KlI ~ ~ ~ ffK l ~ ~K m ~ ~ ~ E~J~F ~ ~J ~ ~ MKV ~ ~ ~ ~ ~J~ ~ ~J ~ MKTKa ~ ~ ~ ~I ~ ~ ~ ~~I ~ ~K^ ~ ~ QR ~ ~ I ~ ~ ~

~ ~ ~Kb K p I ~ ~~I ~ ^~I^~J ~ e~ ^~ ~ ~ ~ ~ ff ~~ Ke Ka~ ~ ~ ~ ~ Q K

5.3.2 Obesityl ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~K q telR ~ ~

Rtel t ~ OMMOK

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~ ~ OO ~ ~K ^ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ K m~ ~ ~ ~I ~ ~ ~ K q ~ ~ ~ ~ ~ ~ ~~I ~ ~ ~

I ~ ~ ~ ~~ ~ K q ~ ~ ~ tel ~ ~ ~ K

q ~ ~ ~ I I ~I~I ~ ~ ~ ~K f ~ ~~~ ~ I ~ ~ ~ ~ ~ ~Kf ~I ~~ ~ ~~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~I ~ ~ ~

S

K t ~ ~ ~ ~ \ t~ ~ ~ ~ \ e ~ \ f ~ ~ ~ ~ ~ ~ ~~ ~ ~ ~ J~~~ ~ ~ ~ K

5.4 Prostate cancerm~ ~ ~ ~ Kb~ ~ ~ ~ ~ ~ RJNM B ~ ~ ~I ~ ~ ~ QMB ~ ~K m~ ~ ~ ~ ~ ~ K q ~ ~ ~ ~ ~W

q ~ ~Ko~ ~ ~ ~ ~K_~ ~ ~ ~K^ ~ ~ ~K

^ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~K ` ~~ ~ ~I

~ ~ ~ ~ ~ ~ ~K ^ ~ ~~ ~ ~ ~ ~ ~ K `~ ~~ ~ ~ ~ ~ ~ ~ ~ ~ ~K m~ ~ ~ ~I~ ~ ~~ K f ~ ~ ~I ~ ~K

S_~~I dKpKI c~I pKI lo~I pK OMMMK

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`~ ~~ ~ ~ ~ ~ ~

5.5 Inflammatory disorders

j~ ~~ ~ ~ ~~ E~I o I ~ ~I ~ ~I ~~~ ~~ ~~ ~F ~ ei^JK q ~ ~ ~ ~ ~

K q ~ ~ ~ ~ ~ EKK b ~ rp^FI ~ ~ ~ EKK ^~F ~I ~ ~ ~ ~ ~ ~ ~ ~K t ~ ^~ ~ ~~ ~ I ~ ~ K

5.6 Mental disorders

5.6.1 Mental retardation

m~ ~ ~~ ~ ~ ~ ~ ~ ~K f ~~ ~ ~ ~ ~ ~~ ~ ~ ~ ~ ~ K ^ ~ ~~ ~ ~ ~ ~ ~~~ ~ ~ ~~ ~ K ^~ ~ ~ p~~ ~I ~ ~ ~TK p~~ ~ ~ ~ ~~ c~ ~ ~K q ~ ~ ~ ~Kt ~ ~ ~~I~~~ ~ ~K j ~ ~I ~~~K

5.6.2 Dementia

j ~ RM ~ ~ ~~ ~I ^~ K p ~ NVVNU I ~ ~ ~ ~K p~ ~ ~I ~ ~ ~ ~ ~~ ~ ~ E~ ~ ~F ~ ~ ~K ^ I ~ ~ ~ ~ ~ ~K

5.6.3 Psychiatric disorders and alcohol abuse

d ~ ~ ~ ~~ ~ ~K r~ ~ ~ ~ ~ K f ~ ~ ~ ~ ~I ~ ~ I ~I ~ ~ K f I ~~ ~ ~ ~ ~K

T^~I mKI ^I pKI o~I hKlKI o~~I gKI qI `KgKI h~I pKiKI v~~~I fK NVTVKU

d~I ^KI `~Je~I jK`KI j~I jKI _I gKI `~I cKI c~I cKI d~I iKIm~Js~ e~I ^KI fI kKI g~I iKI j~I oKI kI mKI oI hKI oI mKI q~`KjKI oI ^II t~I oKI oI jKI lI jKI e~I gK NVVNK

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6. Pharmaco-genetics

`~ ~ ~ ~ ~

~ I ~ ~ ~ ~ ~~J ~K

q ~ ~ ~K f ~ ~ ~ ~ ~ ~ ~ K l ~ NVVT VK^ ~ ~~ ^ ~K q ~ NMU ~ ~ ~ K q ~ I ~ ~ ~~ ~ ~ K q~~ ~ ~ ~ ~ ~~ K d ~ ~ ~ ~

~ K f~ ~J~J ~I ~ ~~ ~ ~ ~ ~~~~ ~ ~ ~ ~ K

q ~ ~ ~ ~ q~~I ~ K q~~ ~ ~ NVRM ~ ~ ~ ~ ~K fNVSNI ~ ~ ~ ~ ~ ~ ~~K ^ ~ ~ ~ ~~ q~K f ~I ~ ~ ~ ~ ~ ~ ~ I ~I ~ ~K

7. Gene therapy

j~ ~~ ~ ~K p ~ ~ ~ ~ I ~ ~ I ~ ~ K

8. What is the task of the physician?

f ~ ~ ~ ~ ~ ~ ~ ~ ~K m~ ~ ~ ~ ~~ ~~ ~ ~ ~ ~~ ~ ~ K f ~ ~ ~ ~ ~ ~ ~ ~ ~~ ~ ~ ~ ~ ~K

_~ ~ ~I ~ ~ I ~ ~ ~

Vo~I cKI eI kKI k~I bKI dI aKI iI oKNVVTK

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`~ ~~ ~ ~ ~ ~ ~

~ ~ ~~ K m ~ J~ ak^ ~ ~ ~K ^ ~ ~ ~ ~ I ~ ~ ~K m ~ ~ ~ K ^ ~ I ~ ~ ~

~ ~ ~ ~ Kt ~ ~ ~ ~I

~ ~ ~ ~ ~ K q ~ ~ ~ ~ ~ ~~ ~ ~ ~ ~ ~ ~ ~ ~ K _ ~ ~ K

t ~ ~ m _ ` ~W q~ ~ ~ ~~ d ~ I ~ ~ ~ `~I q _ iI ~ ~~K q ~

~ ~ ~K o~ ~ ~ ~ ~ ~I ~ ~ ~ ~ ~Kq ~I ~ ~K f ~ ~ ~ ~I~I ~I ~ ~ ~ ~ ~ ~ ~ K

d ~~ ~ ~ ~K q ~ E~FI E~ F ~ E~FKm~ ~ ~ W ~ ~ ~ ~ ~~ ~~K e ~ I ~I ~ ~ ~ ~ ~ ~ ~\ m~ ~ ~ ~ ~~ ~ ~ ~ ~K

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_ p i

References

^~I mI Î pI o~I h~ lKI o~~I g~I qI `~Jg~I h~Ip~Ji~I v~~~I f ENVTVFK p~~ ~ ~ ~ ~ K^ kIsK PSI UUJVQK

_~~I d pKI c~I fK p~I lo~I p EOMMMFK d ~K k~IsK QMQ K SQQJRNK

Ì g eKI _~I p~ ^K ENVVUFK a ~ ~K _j~ g~I sK PNT K NSPSJQMK

d~I Î `~Je~I j~JÌ jI jI _I gI `~Ic~I c~I i~~I d~I iI e~I Î fI kI g~I iI j~Io~I kI m~I oI h~I oI mI q~I ` jKI m~Js~I j~~I oI Î t~I oI oI j~I lI jI e~Ig ENVVNFK p~ ~ ~ ~ ~~ ^ ~K k~I sK PQVI TMQJSK

i~I h~ ENVMNFK ^~ ~ _Kt tI sK OQI NNPOK

o~I cI eI kI k~I bI dI a~I iI o~KENVVTFK ^mlb ~ ~ ^ ~K i~IsK PQVI RPVK

t~I g~I Ì c~ ENVRPFK j~ ~K k~K sKNTNI TPTJUK

tel t e~ o OMMOI ~ QK

sI o ENURUFK a w~~ _ ~ ~ dK _W s~ ^ e~K f YWLL~JKJ~KLLJK[K

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b~ p ~ ~

P

Examples from Swedish biobank research

j~ h~I ma

h~~ fa~ j ~ h~~ e~I `~ b r

q ~I ~ ~ ~ ~ p ~I ~ ~~ p ~ ~~

~ ~ ~ ~~K o~ I I~ ~ ~ ~ ~ ~ K

1. Introduction

q ~ ~ ~ ~ pI ~ ~ ~ ~ ~I ~ ~ ~~ ~ ~ ~K ^ ~ ~ ~ ~ I ~ ~ ~I ~

~~I ~ ~ ~ ~~ ~ ~~ ~K o~ ~ I I ~ ~ ~ ~~ ~ ~K_ ~ ~~ p ~ ~~ K f ~ ~I ~ ~ ~ ~~Kc ~ ~ ~ ~~ ~ ~~~~ I I ~ ~ ~ K

2. Collection of Swedish biobank material:

fK j~~ ~~K p ~ EKK mhrJ ~ ~ ~ FK a~ ~ EKK ~ ~~ FK cJ ~ EKK ~ ~ ~

~FffK j~~ ~ ~ ~ EKK ~

~ ~ ~ ~ ~~ F

fffK j~~ ~ EKK ~ ~F

fsK j~~ ~~K f ~ ~

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j~ h~

K ~ EKK ~ ~FK ~ ~ EKK ~ FK ~ ~ EKK ~~ ~ ~

FK f ~ ~ E F

3. Examples

I a) Research on material collected through screening.

Example 1

Background f ~ ~ ~~ EemsF ~ K _ ~ ~ ~ ~ \ ^ ~ ~

I ~ ~ ~ ~ ~KMethods q ~ ~ ~ p `~oI ~ s ` ~~~ ~ ~ ~I ~~ ~ ~ ~ ~ ~ K c ~ ~ ~ ~ ~ ~ ~~~ ~ ~Kq ~ ~ ~ ~ ~ ~ ~ ~~ K

Results q ~ ~ J ~ ~ ~~ ~ ~~ ~

K q ~ ~ ~ ~ K

Consent ^ ~ ~ ~ ~ Kt ~ ~~ ~ KEt~ ~KI NVVVF

Comments

q ~ ~~ ~ ~

~K q ~~ ~ ~ ~ ~ ~ ~I ~ ~ ~ K c ~ ~ ~ ~ ~ K q ~ ~ ~ J~J K p ~ ~~~ ~~ ~ ~ ~ ~~~ ~ ~~ I ~ ~ ~ ~ K

f I ~ ~W

NK ~~ ~ ~ ~~ ~I

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b~ p ~ ~

OK IPK ~ ~ ~ I ~QK ~ ~~ ~ ~ ~ K

q ~ ~ NVSV NVVR ~

~ ~~ NVVRK p ~ ~~ ~ ~ ~~I ~ ~ ~ ~ ~ K^ ~~ ~ ~ I ~ ~~ ~ OS ~ ~ ~ K

Example 2

Background e~ ~~ ~ ~ ~ ~~~K q ~ ~ I I K

Methods _ ~ ~ k~ ~ c~I ~ ~ ~ ~~ ~ ~~K f~I ~ OU ~ ~ ~ ~ NIRMMK

Results q ~ ~ J ~ ~~ ~ ~ ~ ~ ~K

Consent q ~ ~~ KE_ ~KI OMMOF

Comments

q ~ ~I ~ ~ ~ ~ K q ~ ~ K f~ I J ~ K f ~ ~ ~ ~ ~ NIRMM ~ ~ ~~I ~~ ~ ~ ~ ~ ~ K c ~ ~ ~ ~I ~ ~ ~ ~ K

Example 3

Background t ~ ~~ ~ ~~ ~I ~ ~ ~ ~ ~ ~K p ~ ~ ~~ ~~~K f ~~~ ~I J ~ ~ ~ ~~ ~ J ~ ~ K f II ~ J ~~~

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j~ h~

Background

(cont.)~ ~ ~ ~ ~ K f ~ ~ ~ ~ ~ I ~ ~ ~ ~ ~ ~ ~K

Methods ` ~ ~ ~ ~ ~ ~ ~ ~ K _ ~ I ~ ~ ~ ~ ~ JK p ~ ~ ~ ~ ~~ ~~~ ~I ~~ J ~ ~ ~~ ~ ~K

Results l JI ~ SB I ~ ~ ~ PB ~ K c ~ ~

N NM ~ ~I ~ ~ KConsent ^ ~ I ~ VTB

~~KEi ~KI OMMOF

Comments

q ~ ~K j~ ~ ~ ~ K l ~I ~ ~ ~ ~~ I ~ ~K c I ~ ~ ~ J ~ ~ ~ ~ J~ ~K q ~ ~ I ~ J~~ ~ ~ K f J~~ ~ ~ I ~ ~ ~K f ~ ~ ~ ~ ~ ~ ~~ ~ ~ K _ I ~~ ~~ ~I ~ ~ ~~ ~ ~ ~ K

I b) Research on material collected from tests of suspected disease

Example 4

Background _~~ ~~ ~ ~ ~ ~ ~ ~~ ~ K j I _~~ ~ I ~ ~ ~K

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b~ p ~ ~

Methods ^ ~ ~ ~~ ~ r~~ r e~ _~~ ~~ ~ K ^ ~ ~~ ~ ~ ~ ~ ~~K ^ I

~ ~ ~ ~ ~ ~ K

Results t ~~ ~~ I ~ ~ ~~ K q ~ ~ ~ K q ~~ _~~ ~~ ~ K

Consent q ~~ ~ ~ KEe ~KI NVVVF

Comments

p ~ ~ ~ _~~I ~ ~ ~ ~ ~ _~~ ~~I ~ ~ ~ ~ ~~K r ~ ~ ~~I I ~ ~ ~ ~~K q ~~ ~I ~ ~~ ~ K p ~ I ~I ~ ~ I I I ~ ~~ ~K

Example 5

Background `~ ~I ~ EF ~I ~ ~ N ORMKq ~ ~ ~~ I ~~I ~I ~I ~~K q~ J ~ ~ ~ K p ~~ ~I ~~ ~ K ^ I ~ ~

~ ~ ~ ~ ~ ~K ^ ~ ~ ~ ~ ~ ~ ~I ~ ~I ~~ ~ ~ ~ K _ ~ ~ ~~ ~I ~ ~I~ ~ ~ ~ ~ ~ ~ K q ~ ~I I ~ ~ ~ ~JK k ~ ~ ~ ~ ~ I ~ ~I ~

~ ~ ~ ~ ~K

37


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j~ h~

Methods f ~~ ~ i ~ r r e~I NPP ~ ~ ~~ ~ ~ ~ ~

~ ~K _ ~I ~ ~ ~ ~K q ~ ~~K

Results c ~ ~J I ~ ~ ~ ~ ~ N K q ~ ~ ~~ ~ K

Consent q ~ ~ ~ ~ ~~ ~ ~ K

Ed ~KI OMMNF

Comments

^ ~ ~I ~ ~~ K q ~ ~~ ~ ~ K q I ~ ~ ~ ~ WNK ~ ~ ~IOK ~~ I ~PK ~ ~~K

q ~ ~ ~ ~ ~~ J~~K kJ~~ ~ I J~~ ~ ~~ ~ ~~ ~ K ^ ~~W f ~ ~ ~ ~ I ~ ~ K f J~~ ~ ~I ~~ ~ ~~ K f ~ ~ ~~ ~ ~ ~ ~ J~~I ~ ~ ~ ~ I

~ ~ ~ ~ K

Example 6

Background m~ ~ ~ ~~ ~~~K f ~ p ~ I ~ ~ ~ ~ ~ ~ ~K t I I ~ K

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b~ p ~ ~

Methods ^~ VQIMMM ~ ~ ^ i~~ I p~~ r e~I dI

NVVQ ~ NVVUK ^ I ~ ~ ~ K ^ ~ ~ ~~ ~ ~ ~ ~ ~ ~ I ~ K

Results q ~ ~ ~ I ~ K m~ ~ ~ pI ~ ~~I ~ ~~ K l I QMB ~~ ~ ~ K

Consent c ~ ~ ~ I

~ K c ~ ~I ~ ~ ~ ~ ~ ~ KE~ l ~KI OMMNF

Comments

q ~ ~K q ~ ~ ~ ~ ~~ ~ I ~ ~ ~ ~~ ~ ~K q ~I ~ ~K q ~I I ~ ~ ~K p ~ ~ ~ ~ ~ ~ ~ I ~ ~ ~~K f ~ ~ ~ ~ ~ ~~ I ~ ~ ~ K f ~ ~ ~ ~ ~~ ~ R NM ~I ~~I ~ ~ ~~~ ~ K p ~ ~ ~I ~ ~~~ K

I c ) Research on material collected in connection with treatment or follow-up of a known

disease.

Example 7

Background m~ ~ ~~~~ ~ ~~ ~ ~~K q ~ ~ ~ ~ ~ K f ~~ NMB ~I I ~ ~~Kf ~ ~ ~ ~ ~~ ~~ K

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j~ h~

Methods ^ UR ~ ~ ~ ~~~~ ~ h~~ e~I pI NVTS~ NVVV ~

~ ~K j~ ~~ ~~ K p ~ ~ ~ ~K

Results q ~ ~~ ~~ Kf I ~ ~ ~ ~ ~ ~~~~ ~ ~~ ~~ ~K

Consent q ~ ~ ~ ~ I ~ ~ ~ ~ ~ ~ ~K

Eb bI OMMOF

Comments

q ~~ ~Kq I ~ ~ ~ WNK o m~ ~ m~ `~IOK `~ a~ oPK ~~QK ~I ~RK ~ ~~K

q ~ ~ ~ UVBK p ~ ~I ~ ~ ~ ~ J K ^ I ~ ~ ~ ~ NMMBK p ~ ~~ ~I ~ ~~ ~ ~ ~K q~ I ~ ~ ~ K f I ~ ~ ~ ~ I ~ ~ ~ ~ ~ ~~ ~~ ~~~K q ~ ~ ~ I ~ ~ ~ K qI ~I

~ I I ~ ~ ~ ~ ~ ~K

Example 8

Background q~ ~ ~ ~ ~ ~ ~K q ~ ~ ~I ~ ~ ~ ~I ~ ~ ~ ~~K ^ ~ ~ ~ ~ ~ ~ RPKq ~ ~ ~

40


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b~ p ~ ~

K f ~ ~ RP ~ I ~ ~ ~ ~I ~ ~~ K q ~ ~ ~ ~~ RP ~ ~

~ ~KMethods _ ~ ~ ~ Em`oFI RP

~~ ~~ ~K q ~ ~ ~ ~ K q ~ ~ ~ ~ ~K

Results j~ RP ~~ ~ ~K f ~~ ~ ~ ~ ~ ~ ~I ~ K

Consent q ~ ~~ ~ KE_ ~KI NVVRF

Comments

q ~ ~~ ~I ~ ~~ ~~ ~K q I ~ ~~ ~ ~ K ^~ ~ ~ ~ ~ ~ ~ ~I ~ ~ ~ ~ ~ ~ K f ~~ ~ ~~ ~I ~ ~ ~~ I ~K q ~ ~ ~ ~ ~ ~ ~ K

Example 9

Background i~~ ~ ~~ ~ E FK `~ ~~ ~ ~ ~ K f I

~ ~ I ~ ~ ~ ~ ~ K q ~ I I ~ ~ ~ J~ ~ Kq ~ ~ ~I ~~ ~ ~I ~K j~ ~ ~ ~ ~ ~ ~ K c ~I I ~ ~ ~ K

41


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j~ h~

Methods _ ~ QP ~ ~ ~~ ~ ~ ~~ ~ ~~K m ~I ~ ~

~~ ~ ~I ~ ~ ~ ~ I I ~ ~ ~K

Results ^ ~ ~ QMB ~~ ~I ~PMB ~~ ~K f I I ~ K

Consent q ~ ~ ~~ ~ KEk ~KI OMMOF

Comments

q ~ ~ ~I ~~ ~K f ~ ~~ ~ ~~I ~ ~ ~ ~ K l ~I ~ ~ ~ ~ J ~ ~ ~K f ~ J~~ ~ ~ ~ ~ K q ~ ~ ~ ~I ~ ~K p ~ I I ~ ~ J~ ~ K

II) Research on material collected for future use and diagnostics.

Example 10

Background f JNVVMI ~ ~ ~ ~ ~ ~K f ~ ~I ~ ~ ~~K

Methods _ I ~ ~ ~~J~ I ~ K ^ ~ SMM

~ j~ NVVO NVVQ ~ I NU K

Results p ~ ~I ~ ~ ~ ~ ~ ~ K

Consent c ~~ I ~ I ~ J ~ NPLNU ~ KE_~ ~KI OMMMF

42


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b~ p ~ ~

Comments

q ~ ~K q ~ ~ ~ I ~ K f I ~~ ~ ~ ~ ~ K _

I ~ ~ ~ ~ K

Example 11

Background f ~ ~I ~I ~ ~ ~~ ~ ~ ~ K j ~I I ~ ~~ ~K p ~~ ~ ~~ ~I ~ ~ ~I ~I ~ ~ ~~~ ~ ~K h

~ ~ ~ I ~ ~KMethods p ~~

~~K q ~ ~ ~~~ ~ ~ K

Results q ~I ~I ~ ~ ~ I ~ ~ ~~ K

Consent q ~ KE_~~ ~KI NVVVF

Comments

q ~ K t ~ ~ I ~ ~~ ~ \ g ~ ~ ~ ~ ~ ~ ~ ~I ~ ~ ~I ~ I K l ~ ~ ~ ~ ~ ~ ~K t ~ ~ ~ ~\

III) Research on material collected for mapping:

Example 12

Background p ~ ~ ~ ak^ ~ ~ ~~ ~ ~ ~K a ~I ~ ~~ ~ ~K _ ~ ~ ~ ~I I ~~ K

Methods f q~ oI ~ b~ ~ ~I RO ~ ~ ~~ ~ ~

I ~ J~ ~~ ~~ ~ ~K

43


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j~ h~

Results p ~ ~ ~~ ~~K _ ~~ ~ ~I ~ ~ K

Consent q ~ ~ ~ KEs ~KI OMMNF

Comments

q ~ K q ~ ~ q~ o ~ ~I ~I ~ K q ~ ~ ~ K p ~ ~ q~ oI ~

~ K

IV a i.) Research on material collected exclusively for research, in health care, from

patients

Example 13

Background q ~ EjpF ~ ~ K q ~ I ~ ~ ~

~K q ~ I ~ JS ~ ~ ~ ~K

Methods `~ ~ ~ ~ JSI ~ ~ ~ ~~ K q ~ ~~ ~ ~ ~ ~ ~ K

Results e~ JS ~ ~~ KConsent q ~ ~~ ~

K

Eb ~KI NVVVFComments

q ~~ ~K^ ~~I I ~ ~ ~ ~ ~ ~K f ~I ~ ~ I JS ~ ~~ ~I ~ ~I ~ ~ ~ ~K

44


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b~ p ~ ~

Example 14

Background f ~ ~ ~ ~ ~ ~K i ~ ~~ ~ ~ ~~

~ ~ ~KMethods _ ~ ~ VUU ~ ~

~ ~ ~~ NVUR ~ NVUTKf NVVUI ~ ~ ~ ~ ~K i ~ ~~ ~I ~ ~ ~~ ~ ~K

Results i eaiJ ~~ ~ ~~K eai ~ ~~ ~ ~~ ~ ~ ~K pI iaiJ ~ ~~ ~ ~ ~K q

~ ~ ~ ~ ~ ~ ~~ ~I ~ ~ KConsent q ~ ~ ~ ~

KEi~ ~KI OMMOF

Comments

q ~ ~ ~ ~ K q ~ ~ ~ ~~I ~ ~~ ~ ~K q I ~ ~ ~ ~ ~ ~~ ~ K q I ~~ ~ `~ a~ o ~ o m~ ~ m~ `~K p ~ ~ ~ K f ~ ~ K b ~ ~ ~ ~ ~ ~I ~ ~ ~~~ ~K i ~ ~ ~ ~K q ~ ~ ~ ~ ~ ~ ~K

IV a ii.) Research on material collected exclusively for research, in health care, from

deceased individuals.

Example 15

Background p~ ~ ~ ~ ^ ~K q ~ ~ ^~I ~ ~I ~ ~ ~~I K q ~ ~ ~~K

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j~ h~

Methods q NUU ~ ~ ^ ~ ~ ~ OMM ~ ~ ^ ~K q ~ ~~K

Results ^ ~ ~ ~ ~ ~ ~ ~~ ^ ~K

Consent q ~ ~ ~ ~KE_ ~KI OMMMF

Comments

q ~ ~ ~~ ~ ~ ~ K c ~~ ~ ^ ~I

~ ~ ~ ~ K

IV a iii.) Research on material collected exclusively for research, in health care, from

healthy individuals.

Example 16

Background fJ ~JN EfdcJNF ~ ~ ~ ~~ ~ ~ ~ ~ ~~ K i ~~ ~ ~K

Methods j~~ ~ sI sfm ~ j~ I ~ K q sfmJ ~ ~ ~~~ ~ ~ ~K f I~ s ` ~ ~ ~ ~ ~ PMI QMI RMI ~ SM ~K f ~~I ~ ~ I ~ ~ ~ RMIMMM ~ ~ ~~K q j~J~ ~ ~ ~ SIMMM ~~~ ~K ^ ~ ~ ~

~ K c ~~I K _ ~ ~ ~ ~~ fdcJNK

Results e fdcJN ~~ ~ ~ ~ ~ ~ ~K

Consent ^ ~~ ~ ~ KEp~ ~KI OMMMF

46


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b~ p ~ ~

Comments

q ~~ ~ ~K q I `~ a~ oI `~ oI ~ o m~ ~m~ `~K q ~ ~ ~ ~~

~ K f ~ ~ ~ ~ ~~ ~I ~ ~ ~K q ~ K p ~ ~ ~\

Example 17

Background p ~ ~ ~ ~ ~ I I ~ ~K ^ I ~ ~I

~ ~K m ~ ~~ ~ ~ ~I~ ~ ~ ~ ~~ ~~ ~~ K f ~ I I K

Methods f p q oI PS ~ K p ~~ ~I K q ~I ~ ~ ~ pK

Results ^ ~ ~~ ~ ~ ~ ~ K

Consent l PS I OU ~ KEo ~KI OMMNF

Comments

q ~ K ^ ~ ~ ~ ~ ~ ~ ~~ ~ ~ K p ~ ~ ~ TRBI ~ ~ ~ ~I ~ ~~ ~

~ ~~K q I ~~ K

Example 18

Background p ~ ~ ~ ~ ~K j I ~ ~ ~ m ~ K q ~~~ K ^~ ~ ~ ~~ K ^ ~ ~ ~

47


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j~ h~

Background(contd.)

~~ mK q ~~ m ~ ~ ~ K

Methods _ NVTQ ~ NVUOI NOIRMM ~~ ~ ~ ~ K p

I QMM ~ ~K c ~ ~ ~I I ~ ~~ ~ ~ ~ ~K

Results i m ~~ ~ ~~~ ~K

Consent ^ ~~ ~ ~ KEmJj ~KI OMMMF

`

q ~ ~ ~ ~ ~ ~ K q I `~ a~oI `~ oI ~ o m~ ~ m~`~K q ~ ~~ ~~ ~ K q~~ ~ ~ ~ ~K kI ~ ~ ~ ~K

48


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b~ p ~ ~

References

_~~I iKI p~~I `KI pI ^KI tI dKI p~I dKI _I fKI jI gKI^~I mK lK ~ e~I mK ENVVVF b e~ mINMTI USTJTNK

_I gKI kI qKI pI pKI iI ^K ~ eI iK ENVVRF k~ jININMOVJPQK

_I qKI b~I ^KI i~I qKI jI gKI dI oK bKI gI bKI h~I mKIiI jKI m~~I bKI qI pK lK ~ aI gK EOMMOF _ g `~IUTI SNJQK

_~I mKI pI dKI sI _K ~ tI ^K EOMMMF s p~ITUI NQPJUK

_I hKI oI ^KI mI gK ^KI _I ^K gKI b~~I qKI t~~I `KI_~I kKI ^~I kKI _~~I pKI j~I gKI k~~I hKI t~I ^KI o~I_KI lI eKI eI `KI a~I mKI jI iKI g~I ^KI m~I iK ~oI iK EOMMMF g k~ q~INMTI NMSRJTVK

b bI bK EOMMOF m~ ~ ~~ ~~~~ W ~ ~ ~I h~~ KI pK

bI jKI t~I cK wKI cI pKI j~I `KI a~I eK ~ iI ^K ENVVVF à~ i~ fISI RQRJVK

dI bKI f~I ^KI gI mKI lI mKI c~Jj~I hKI mI iK ^K ~eI lK EOMMNF ` a~ i~ fIUI RSQJTMK

eI jKI jdI pKI bI `KI tI iKI eI bKI a~I gKI _~I iKI

b~I iKI oI oK ~ c~I dK ENVVVF g ` jIPTI NPUNJQKiI oKI i~I iKI qI lKI Î eK ~ e~~I ^K EOMMOF^~ ld p~IUNI OQMJQK

i~I rKI eI gKI h~I qKI iI qK ~ tI lK EOMMOF g f jIORNI NNNJUK

kI ^KI a jI ^KI bI mKI kI jKI k~~I jKI dI iKI Ì cK ~_I lK EOMMOF m~INMVI VNK

mJjI jK bKI p~I iKI Î _K ~ i~I cK EOMMMF k `~I

PSI NVJOSK

oI ^KI o~I dKI cI hKI Î jKI j~~I `K jKI d~I aK ~kI aK ^K EOMMNF kIQPI OPPJSK

p~I mKI _I ^KI o~I pKI _I `KI a~I eKI p~I rK eKI b~I iKIoI bKI e~~I dK ~ h~~I oK EOMMMF g k~ `~ fIVOI NVNMJTK

t~I hK iKI tI cKI Î qKI _~I cKI p~I rKI t~I dKI e~~IdK ~ aI gK ENVVVF k b g jIPQNI NSPPJUK~ lI gKI Î pKI _I rKI eI iK ~ _I jK mK EOMMNFÎRSI

RTPJTK

49


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j~ h~

sI fKI h~~I gKI i~I jK aKI tI ^K aKI j~I pK dKI j~~I ^K~ e~~I iK EOMMNF b g e dIVI RVMJUK

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`~ d `~ ~ _~

Q

Clinical genomics companies and biobanks

The use of biosamples in commercial research on the genetics of common diseases

^~ m g i~~Je~

`~ r q

~ f j~~ f~ ~ q EfjfqF

m~~~ ~ ~ ~ ~ ~ ~~ ~ ~J ~ ~ ~ ~~ K a J~ ~ ~ ~~ ~ ~ ~ K ^I ~ ~I J~ ~ ~~ ~ ~ ~K q ~~ ~ W` d f~I l~ rhI ~ r~d pK qI ~ ~~I ~ ~ ~ ~ K

q ~~ ~ ~ I ~ ~ ~ ~ ~~ ~K a ~ ~ I ~ ~~~ K kI ~ ~ ~ ~ K

1. Introduction

f ^ NVVSI ` dI ~ J~~J~ ~J~ ~ I ~ ~ f~ ~ h~ p~ ~ e~~ j~ p ~ g dKq ~ ~ ~ ~ ~ ~ ~ ~ f~ ~K q ~ ~ ~I ~ ~ I ~~~ ~ ~ ~ K ^ ~~ ~ ~ ~I ` ~ ~ ~~ ~ cKe~Ji~ oI ~ ~ jrpa OMM ~ ~ ~I ~ ~ ~ ~K` ~ ~I ~ JOMMO ~ SRM

I ~ f~I ~ ~ ~ jrpa PM ~~ K

51


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g i~~Je~

` ~ ~ ~ ~~~ E~NF ~K _ ~ ~ ~ ~ ~~ ~ ~~ ~ E~ ~ ~ f~ ~ ~~ ~ ~ ~~~ f~ ~FK p~

~ ~ ~ ~ ~I ~ bI ~ ~ rp ~~ ~ K f ~ ~ b ~~ ~ rp ~ ~ ~I ~ ~J~ ~~KOf NVVTI ~I l~ ~ rh ~ lK q ~ ~I NVVVI r~d ~ ~ p ~ ~ ~J~ ~K jI ~ ~ ~ ~ b~I ~ ~~ ~ K

q ~ ~ ~ ~ ~ ~ ~~~ ~ ~ P ~ I ~ ~ ~ K q ~ ~ ~ ~I ~ ~~ K f I ~ ~ ~ ~ K f I ~ ~ ~ ~~ ~ ~ K q ~ ~ ~K k ~ E` dI l~I ~r~dFI ~ ~~K ^ ~ ~K

2. The clinical genomics company: some features

^ I ` ~ ~ ~ ~~ ~ K q I ~ ~ ~I ~ ~ K l ~ ~ ~ ~J~ ~ ~ ~ ~~ ~ K q ~ ~

~ ~ ~ K f ~ ~

N_~ ~ ~ ~ ~~I ~ ~ ~ ~ ~ ak^K l ~ ~ ~J~ E ~F~ ~ ~ ~ ~J~ ~ ~ ~ ~K ^ ~ ~ ~ ~ ~ ~I ~ ~ ~ K q ~ ~J~~ ~ ~ K q ~J~ ~ ~ ~J ~ ~I KKI KOc ~I b~ ~ ~ I ~ ~~I ~ ~ ~ K `~ rpI ~ ~ ~

~~ ~KPc ~ I ~~~ ~ ~~~ ~ ~ ~ ~ ~ ~K

52


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`~ d `~ ~ _~

~ QIPMM ~ K q rp ~K f OMMNI NIQRP ~ NQNIMMM ~ _rpa ORK _ ~I b ~ NIUTV ~I ~ ~ rp ~I ~PQIMMM ~ ~ ~ _rpa TKR KQq ~ ~

~ rh ~ d~I c~ ~ pK^ ~ ~~ ~ I ~

~ ~~ ~ ~I ~ ~K f I ~ ~ ~ E~~ ~ ~FK

f NVVMI I ~ ~ ~ EKKI ak^ FI ~ ~ ~ ~ J~ EF ~ ~

I EJ~~F ~K f ~ ~ ~I ~ ~ ~ ~I ~ ~ ~J ~ ~ ~ ~ J~ ~ ~ ~K ph _~~ jrpaNOR e~ d p NVVP ~ ~ K p I ~ ~ ~ I ~ rpI ~ ~ ~ ~ ~~~ K q ~ ~~ ~ ~ ~ ~ ~K mI ~~~ ~ ~ RMM ~ K f ~ ~ ~ ~ ~ ~ ~ ~K ^ ~ ~ ~ ~ J~ ~~ ~I ~~ ~ ~ ~ ~ OMJPM ~ ~ ~ EIKKI o eI OMMMFK

m~~ I ~ ~ ~j m~~~ ~ dI ~ ~ ~ ~ ~~J~ ~I ~ ~ ~ ~~K

^ I ~ ~ ~

~ ~ ~ E ~F ~~I ~ ~ ~ ~ ~ ~ ~~K f ~ ~J I ~I ~ ~J~ ~K f ~ I ~I ^~I ak^ pI adI d`~~I j~ d ~ pI ~ ~ rp K p~d ~ k~ d ~ `~~~ ~ ~ K _ ~J b~ ~ ~ ~ I d c~ ~ ~ ~ ~ ~ ~b~ ~ ~ ~K d d rh ~ ~ ~ I ~ ~ ~ ~ ~

Qq ~ ~ ~ b C v EOMMOFK

53


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g i~~Je~

pI ~ J~ ~ ~~ ~ ~ rpK _~ ~ d ~ ~ b~ j~ pI ~ ~ ~~ ~ ~ ~ ~K f ~~ pK rI ~ ~ ~ bI ~ b~ bI p ^ ~ f~ rspI

~ I ~ ~~ ~~~ ~~ K

2.1 The use of biobanks

p ~~ ~K _ ~~~ ~ I ~ ~ ~ ~ K eI ~ ~~~ ~ ~ E ~F ~~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~ ~ ~K ^ ~~ I ~ ~ ~ ~ ~ ~ ~

~ ~ ~ ~ ~ K eI ~ I ~ ~ ~ ~ ~K

q ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~Kp ~I ~ rp ~ I ~I ~I ~ ~ ~ ~ ~ ~~ ~ ~ ~ E NFK l ~ ~ ~ I ~ ~ E OFK q ~ ~ bK

Figure 1. Genomics company with its own biobank

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Figure 2. Genomics company without its own biobank

2.2 Exploitation of the research results

t ~ I ~ ~ ~ ~ ~K p ~ ~ ~ ~~~ ~ ~~ ~ ~~ ~ ~K f ~I

~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~ K f ~I ~ ~ ~ ~ ~I ~ ~ ~~ I ~ ~ ~ ~ ~ ~ ~ ~ K c I ~ ~~ ~ ~ I ~ ~ K

q ~~I ~ ~ ~ ~ K l I ~ ~ ~ ~ I ~ I ~ ~ ~~ ~K q ~I ~ ~ ~

I ~ ~ ~I ~ ~I ~~ I~ ~ ~I ~ J ~~ ~ ~K f I ~ ~ ~ ~K q ~ ~ ~ ~ K cI ~~~~I ~~ ~ I ~~ ~ ~ ~ ~~ ~ ~ K qI ~ ~ ~ ~ ~ ~ ~ ~~ K pI ~~ ~ ~ ~ ~ ~ ~ ~ ~ ~K q ~ ~ ~ ~~ I ~ ~ ~I ~

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~K q ~ ~ J ~ I ~ ~ ~I ~ ~ ~ ~~ ~K

p J I ~ ~ ~ E~

~ FK c ~I j~ d rp ~ ~ ~ ~ ~ I ~ ~ KRl I ~ e~d pI ~ ~~~ K

q ~ ~ ~ ~ ~ ~ ~ ~ ~~~K q ~ rp~ `~ d ~ fK q ~ ~ ~ K eI `~ ~ ~ ~ J~ ~~J~ ~K

2.3 The role as intermediary

^ ~ ~~ ~I J ~ ~ ~~~ ~K q I ~~~ ~ ~ E ~ ~ FK q ~ ~ ~ ~ ~ ~ I ~ ~ ~ ~ ~~ KS

^ ~ I ~ ~ ~ ~ ~I ~ I ~ ~~~~ ~ ~ ~ ~K q ~ ~ ~K q ~ ~ ~ ~ ~K q ~ ~ ~I ~ ~~ ~ ~ I ~ ~ ~ ~ ~ ~K `J~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~K

^ ~ p~~~ ~ ~I I ~ ~ KT f~I ~ ~~ ~~ ~ ~ ~ EKK ~ ~ ~ ~ ~FK ^ ~~ J ~~I ~~ ~

~~K q ~ ~ ~ E ~ ~ FK ^ ~ ~ ~ ~K ^ J~ ~I ~~~ ~

Rj~ dI ~ p~ i~ `I ~ ~ ~ ~ j r~K i f~I j ~ ~ ~K EpI KKI oI eK OMMNI K UFSq ~ I ~ ~ ~ ~ ~ ~ ~I

`~~ aK q ~ ~ J~ ~I ~ ~ f~~ k aI ~ ~ ~KTi~~Je~I gK OMMN~ ~ K

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`~ d `~ ~ _~

~ ~ ~ ~ ~ I ~ K

q J~ ~ ~ ~ pI ~ ~ ~ EKFK _ ~ ~~~ I ~ ~~ J~ ~

~~ ~ K q ~ ~ ~~ ~ ~ ~ ~~ ~ ~ ~ ~ ~~~ ~ K f ~ ~~ ~ ~ ~ ~ ~ ~I ~ ~ ~ ~ ~ ~K q ~ ~~~ ~ ~ ~ ~ ~~ ~~ ~K q ~ ~ ~ K

a J~ ~ J~ ~ ~ ~~J~ ~ ~ ~ ~ ~ ~

~K f ~ ~ ~ ~I ~ EJF ~ ~ ~ ~ ~ K ^ ~I ~ ~ ~ ~~~ EKKI ~ ~ ~ ~ ~FK eI ~ ~ ~~~~ ~ ~ ~ ~ ~ ~K l~ ~~ ~ ~ ~ ~ K ^ J~I ~I ~K f ~ ~~ ~ ~ ~ ~ J~K q ~ ~ ~ ~ JNVVM ~ ~ ~ K

k ~I ~ ~ ~ ~ ~ K ^ ~ ~ I ~ ~ I ~ ~I ~ ~ ~ ~~ ~ ~ ~ ~ ~ ~ ~~K q ~ ~ ~ ~I ~ ~ ~ ~ ~ ~~Kf I ~ ~ ~ ~~ ~

~ ~ ~ ~~ K

3. The commercial use of biobanks: important issues

q ~ ~ ~ ~I ~ ~I ~~ ~ ~ ~K i ~ ~ ~ ~ ~K t ~ ~ ~ K cI ~ ~ ~I ~ I ~~ K p ~

~ ~I ~ ~I ~I ~~ ~I~ ~I ~ ~ ~K l

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`~ d `~ ~ _~

q ~ ~ ~ I ~ ~ ~ I ~K f ~ ~ ~~ ~ E ~~ FI ~ ~I ~ ~ ~~I ~~ ~I ~ ~ ~~ ~

~ ~K f ~ ~ ~ ~ EKK~FK f ~ ~ ~ ~ ~ ~~I ~ ~ ~ ~ K _ ~~ ~ ~ ~I ~ ~ ~ ~ ~ I ~ ~ ~~ ~ ~~~ K

p ~ ~~I ~ ~~ ~ ~ ~I ~ ~ ~ ~ K f~I ~ ~ ~ ~ ~ ~ ~ ~ K

^ ~ I ~ ~ ~

~ ~ ~~K q ~ ~ ~I ~ ~ ~ ~ K f ~ ~ ~ ~~ ~~ ~ ~ ~ K b ~~ ~ ~K

l ~ ~ ~ PI ~ ~~~~ ~ ~ ~ ~ ~ ~I ~ I ~ ~ ~ ~K

3.1 Organising the focal relationship

q ~ ~~ ~ ~ ~ ~ ~ ~ ~ ~I ~~ K ^ ~ ~ ~ ~K _~ ~~ ~ I ~ ~W

t ~ ~ ~ ~ ~\

t~ ~ ~ ~ ~\q ~ ~ ~ ~~ ~ \

e ~ ~ ~ ~ ~ EKKI ~ ~F\t~ ~ ~ ~ ~ ~ ~\

q ~ ~ I ~ ~ ~ ~ ~K _ ~ ~ ~I ~ I ~ ~ ~ ~ K q ~ W

t ~ ~ ~ ~ ~ ~ \

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g i~~Je~

e ~ \ f ~~I ~ ~ ~ ~\ e ~ ~ ~ \

e ~ ~ ~ ~~~ ~~ ~ ~ \

3.2 Organising the biobank unit and the genomics company

q ~ ~ I ~ ~ ~ EF ~ ~ ~I ~ ~K b ~ ~ ~ ~ ~~~ I ~ ~ ~ ~ ~K c~I ~~ ~ ~ ~ K ^ ~ ~ I ~ ~~ ~ I ~K qW

t ~J~ ~ ~ ~ ~ ~ ~ \ El ~ ~ ~ KFt ~ ~ J\

f ~ ~ ~ ~ ~ ~ ~ ~~ ~ ~ ~ ~K _ ~ ~~ ~ ~ ~~ ~ ~ ~I K

q ~ ~ ~~~ ~ ~~ ~ ~~ ~ ~~W

c~I ~ L~l~~ ~ ~~ d~ I ~ ~ ~ ~ p ~ ~ ~ EKK ~~ Fj~ ~ EKK ~ ~ L\F

^ ~ ~ ~ ~ ~I ~K

3.3 The performance of biobank ventures

q ~~ ~ ~ ~~ ~ ~~~ ~ ~ ~ ~ ~ K a ~I ~Km~ ~ ~ ~ ~~ ~ E QFK f~ ~~ ~ E ~FI ~ ~ ~I ~ ~I ~ ~ ~ ~ KcI ~ ~ I ~I

E~ ~ ~F ~ ~ ~~K

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Figure 4. The performance of commercialisation ventures

lI ~ ~ ~ ~ ~ ~ ~~K ^ ~ I

~ ~ ~~K c~I ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~E~ ~FKj~ ~ ~ ~ K _ ~ ~ ~ ~ ~I ~ I I ~ ~ ~ E ~ ~~ ~ FK l ~I ~ ~~ ~ ~~ ~ EF ~~~I ~ ~ ~ I K f

I ~ ~ ~ ~ ~ ~~~ Kf ~ ~ ~~ ~ E~ ~

F ~ ~ K b ~ ~ ~~ ~ ~ ~ ~I ~ ~ ~ ~ ~ ~ ~K q~ ~ Q K eI ~ ~~ ~ I ~ ~ ~~K

q ~ ~ ~ ~ ~ I~ ~K c ~I ~ ~ ~ ~~~ ~ ~ ~ ~ ~~~

~I ~ J~ ~KcI ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~~K ^ ~ ~ ~ ~I E ~F ~ ~ ~ ~ ~ ~ K f I ~ ~~ ~ ~ ~K q ~ ~ ~ ~ ~ ~ ~ K

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4. The methodology of the study

q ~ ~ ~ ~ ~~~KV q ~ J ~ r~JdI ~ ~ ~ ~ ~J~ ~

k p ~ ~K q ~ ~~K f ~ ~ ~ I ~ ~ ~K m~I ~ ~ ~ ~ pK

^ ~ r~d ~ ~ ~ ~ ~ ~~ ~~I ~~ ~~ I~ l~ ~ `I ~ I Kq ~ I ~ ~~ ~K

f ~I ~ ~ ~K q ~ ~ ~ ~ ~~ ~~ I ~ K c ~ ~ ~~ ~I ~ EKFK

q ~~ ~ ~ ~ ~I ~ ~ ~ J~ I~I ~ I ~ ~ K ^I I ~ ~K ^ ~ I ~~ ~I ~ ~ ~ K

5. deCode Genetics

5.1 Background and history

` ~ ~J~ ~ ~~ ~ ~~ ~ ~ o~I f~K ^ ~~ ~I ~ NVVS h~ p~ ~ g dI ~ ~ ~ f~ ~~~ ~ ~ ~K l~~ ~ ~ f~ ~ ~ ~~~ ~~ ~ ~ ~ ~K _

~ ~ ~ ~~ ~ ~ K q ~~ f~ ~ ~ ~ ~ ~ ~ NVNR ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~ ~ ~ ~ ~~~ ~ ~K

q ~ K q ~ ~ ~ ~ ~~ ~ ~ ~ f~K f ~~ ~ ~ ~ ~~ ~ ~ ~K` ~ ~ ~ ~~ ~ ~ ~ ~ ~ ~ ~K q ~ ~ ~ ~~

Vi~~Je~I gK OMMPK

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`~ d `~ ~ _~

~ ~ ~~~ ~Kq ~ ~ ~ ~ ~I ~~~ ~ I ~~I ~ ~ ~ f~ ~K f ~ ~ ~ ~~~ ~ ~~ ~~ ~ ~ ~K

c ~~ ~ rpI ` ~ ~ ~ ~K f NVVUI ` ~ ~ ~I ~I cKe~Ji~o EoFI ~ ~ p ~~~ ~K q ~ ~ `jrpa TM ~ I ~ jrpa NPM ~ ~ ~K

f OMMMI ~ K cI f~ ~~ ~ ~ NOJ~ ~ ~ f~ e~ pa~~~ EfeaFK q ~ ` ~~ ~ ~ ~ ~ J ~I ~ ~

~~ ~ ~ ~~~ ~ J~~ ~K q ~~~ `I ~ ~ ~ ~~I ~ ~ ~ ~ ~ ~ ~J~ KNM pI` ~ ~ ~ k~~ ~b~~ ~K

f g~~ OMMOI ` ~ o ~ ~~ ~ ~ ~K _ ~ ~ ~ ~ ~I ~ ~~ ~ ~ ~ ~ ~ ~ ~ ~K q ~ ~ ` ~ ~ ~ ~I ~ ~~ ` ~ ~ ~ ~ J K

q~ ~ ~ o ~ ~~ ~~ ` ~ ~ ~K b~ OMMN ~jrpa PNKSI ~ JOMMO ` ~ SRM I ~ f~K i ~ I ` ~ ~~ Ejrpa QTKU OMMNFK

5.2 The use of biobanks in deCodes research

q~ fea I ~ I ` ~ ~ ~~K eI f~ ~ ~ ~ ~K f I ~ ~ I ~ ` ~ f~ K f ~I ~~~ ` ~ ~ ~ ~ ~~ ~ ~I ~ ~ ~ K f I I ~ `

NMq ~ NVVU ~ ` I ~ ~ ~ fea ~ ~ VJ ~K ` ~ f~j~ ^~I ~ I ~ ~ ~ ~ ~

~K kI ~ feaI ~ ~ ~I ~ ~ ~ ~ ~ ~~K c ~I ~ ~ ~ I ~I ~ K

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~~ J ~~ fea ~~ ~ ~ ~ ~~~K qI ` ~ ~ ~~ ~~ ~ ~ ~ ~ ~K t ~ K

cI I ~ ~ ~ ~ fea K f

~I ~~ ~ K q ~ ~ ~ ~ K cI` ~ ~ ~ ~K

_I ~~~ ` ~ ~ ~ ~ K q ~ ~JK r~I ~I ~ ~ ~ ~ ~ E ` ~ ~~~I q _ f~F ~ ~~ ~K q ~~I I ~ ~I ~

~ ~K f k~~ _ `~ a~~ m ^K ^ ~I ` ~~ ~ ~ I ~ J ~~ ~~ `I ~ ~~ ~ ~ ~~ ~ ~K q~ ~ ~ ~ ~~ ~ ~ ~ `K

^ I ~ K q ~ ~ I ~ I ~ ~K f ~ ~ ~ ` ~ ~ J ~K ^J ~ ~ `I UUJVS ~ K ` ~ ~ ~ TMIMMMJUMIMMM ~ ~K

q ~ ~ ~ ~ ` ~ ~ ~ ~ ~ ~K eI ~` ~ ~ ~ ~~I ~ ~K qI ~ ~~ ~K

q ~L~ ~ ` ~ ~ ~~ ~ ~ ~ ` ~K f ~ ~ ~ ` ~ ~

~~ ~ ~ ~ ~K ^~I J~I ~I ~ ~ ~ ~ ~ ~ ~ ` ~ K t ~~I ~ ~ ~ ~ ~ K f ~I ~I ~ ` ~ K q ~ ~ ~ ~ I ~ ~ ~ K

t ` ~~ feaI f~I ~ ~ I ~ ~J~ ~ EKK ~ ~

b~ ~ rhFK f~I ` ~ ~~ ~ ~ ~J~ K eI

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`~ d `~ ~ _~

~ ~ ~~ ~ ` ~ ~ ~ ~I ~ ~ ` ~ ~ ~ ~ ~ f~ ~K

5.3 The development of the company and the database project` ~ ~ ~ ~K ^ ~I ` ~ ~ ~ ~ J ~K ^ I ~ rp ~ ~ ~ ~ ~ ~ ~ OMMOK q ~ I ~ ~ ~~ ~ ~ ~K ^ ~ I ~~ ~ ~ ~ ~ I ~ ~KNN^ ~ I ` ~ l OMMO ~ ~~ ~~~ ~ K q ~ ~ I ~ I SRM QRMK j

~ o~J~ ~ ~K q~ ~ ~ ~ ~J OMMPK f ~ ~ ~ ~I ~ ~~~ ~~ ~~ I ~ ~ ~ ~ ~ ~ ~~K

q fea `I ~ ~~ ~ ~ ~ K c ~I ~ ~ ~ ~~~ ~ ~ K ` J~ ~ ~ ~ ~I ~ K q fea ^ ~ ~~ a NVVU ~ ~ E ~ ~ ~ I ~ FK f ~ ~ ~ ~~~ ~ ~ ~ K q ~ ~ f~I ` ~ I ` ~ K f ~ ~ ~K ^ ~ I ` ~ ~ ~ fea I ~ ~ ~ ~ ~JKNO

6. Oxagen

l~ Elu ^ dbkF ~ NVVT ~ ~ ~ r l ~ t q ` e~dK m g _I J ~ ~ I ~ ~ ~ ~ ~ ~

NNt ` OMMMI ~ ~ rpa NUK kI ~ OMMO ~ ~ ~ rpa OKNO

l ~ ` ~ ~K e~~ ~ ~ ~ ~ ~ f~ ~ mo ~ ~ K

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~ ~ ~ ~ ~ ~K _ ~ ~ ~ ~ ~ ~ I ~ ~ ~I ~~ ~ ~ K qI ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~

~~K q ~ ~ ~~I ~ ~J~I ~ ~~I ~ ~ ~~ ~~ ~ ~ K q ~ ~ ~I ~I ~ ~ ~ ~ ~ ~~K m~ ~ ~ ~ I ~ ~ I ~ ~ K

l~ ~ ~~ ~~ I KI ~~~ ~I ~~ ~ ~~L K q ~ ~ ~ ~~~ ~J~ ~ ~ ~

~ ~ ~~K c ~ ~ ~ ~ ~~~ ~K q ~ ~I ~ ~ ~ ~~ ~ ~I ~ ^~ p E ^~w~F NVVUK q ~ ~ ~ ~I OMMO ~~ ~ ~~ ~ ~ m rpK

c ~ ~ ~ ~~ ~~ ~ l ~ ~K qI ~ ~~~I l~ ~ ~ ~ ~~ ~ K q~I l~ ~ J~ ~J ~ ~ I ~ rh ~ b~K

q ~~I l~ ~ ~ ~ ~ ~ ~~ ~ PQIMMM ~K q ~ ~ ~ ~ ~ ~ ~ ~K

f OMMNI l~ ~ PKP ~ oCa ~ NNKT K q ~ UKT K f OMMOI ~ ~ ~ NMM K

6.1 PROCARDIS: an example

q ~ ~ ~ ~ E`âF ~ ~ l~ K eI rhI d~I f~ ~ p ~ ~ ~mol`ôafpK q ~ ~ QIMMM ~E~~ NRIMMM ~F `âJ~~ ~ ~ ~ ~K

k~I l~ ~ ~ ~ ~ ~ ~ ~ ~K eI ~ ~ ^~w~ ~

~ ~ ~ ~ ~ K

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`~ d `~ ~ _~

q ~ ~ ~ ~ ~K ^ ~~I ~ ~~ K ^ ~ ~ ~ l~ ~I ~ ~ ~Kl~ ~ ~ ~ ~ ~~ J K q

~ ~ ~ ~ ~ ~~ ~ ~~ l~ ~ ^~w~Kq ~ ~ K

f ~I ~ ~ ~I ~ ~ ^~w~K f I l~ ~ ~ ~I ~ ~ ~ ~ ~~K

q ~ ~ ~ ~ ~ ~~ ~K f ~ ~ ~~~ K

^~w~ ~ ~~ l~ K_ ~ ~ ~ ~ I ^~w~ ~~ l~ ~ ~ ~ ~~ ~ ~ ~ ~~ ~~ ~K q~ ~ ~ ~~~ ~ ~~ ~K q~ ^~w~ ~~ ~ ~ ~ K

6.2 Some recent changes

l~ ~ ~ ~~~ ~ ~ ~ K f ~I ~~ ~ ~~ ~ ~ Kq ~ ~ ~ l~ ~ I ~ I J ~~K q~ ~ ~ ~ ~ OMMOKq ~ ~ ~ ~ ~~ ~ K f I ~ ~ ~K f~ J ~ l~ ~ ~~ J~ ~ ~ ~ ~ ~ ff ~ Kf ~ I l~ ~ K

d ~ ~ I ~ ~

~ ~ ~ ~ K q ~ ~~ ~ ~~K

q ~~ l~ ~ ~ ~ ~~~ ~~ K ^ ~ I ~ ~ ~ ~~K ql~ ~ ~ J ~ OM E FI ~ ~ ~I ~ ~ ~K

l ~I ~ ~~~ ~

~ ~ ~ ~ ~ ~ ~

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g i~~Je~

~ ~ ~ K t ~ ~ K

7. UmanGenomics

q ~ ~ ~ ~ r k pK f ~ NVVV ~ r r ~ s ``I ~ j~ _~K q ~ ~ ~I ~J~ ~ ~ ~ JNVUM ~ ~ ~ ~ UTIMMM ~K q SSIMMM ~ ~ ~ ~ ~ ~J ~ E sfm FK

^ OMMOI r~d ~ NS K q ~ ~ ~ K

7.1 Historical background

q ~ ~ ~ ~ ~ ~ ~ ~ ~K ^ I ~ ~ ~ ~ ~ ~ ~K ^ ~ d~ e~~I ~ j~ _~I ~~~ ~ ~ ~K f I I ~ ~ ~ r r E ~ ~~~ OMMMFK

f I ~ ~ ~ ~ ~ I ~ ~ ~ ~ K eI JNVVM ~ ~ ~ ~ ~ ~ ~ ~ K f ~ ~ ~ ~ ~ ~ ~~ ~ ~ ~ ~ ~ ~K qI ~~ ~ ~ ~~ I ~ r ~ K

q ~ ~ ~ ~ ~ ~ NVVMI ~ K f ~ ~~~~ ~ ~ ~ ~ ~ ~K q ~ d~ e~~

~ ~ ~ ~~ J~ ~ ~ ~ ~ ~ ~K f~I r r~ s ` ` NVVU ~ r~dK q~ ~ ~ ~~~ ~ ~ ~ ~ ~ ~~ ~ ~~~ ~Kr~d ~ ~ ~ ~ sfmJ~ ~ K f ~ ~ ~ ~ ~ ~~ I ~ ~ K f K l ~ I ~ K pI

~ ~ ~ KqI ~

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`~ d `~ ~ _~

E ~F r~dK

d~ e~~ ~ ~ ~ ~ ~~K q ~ ~ ~ ~ ~ ~ ~I ~ ~ ~

~ K q ~ ~I ~I ~~ ~ ~ ~ ~ ~I ~~K q ~ ~ ~ ~~ ~ K qI ~ ~ ~ ~ ~ ~ r~Jd ~ K

7.2 The development of the company

q ~ ~I m p o ~ ~ E`blFK e ~ ^~I ~ ~ ~~ K e ~ ~ r r ~ ~~

~ j~ _~K f NVVV ~ ~~ ~ ~~ ~Ko ~I r~d ~ ~

~J~ I I ~ ~ Kl~I ~ ~ ~ ~~~ ~K ^ I ~~ ~~ pkm ~~ ~ ~ E ~ ~ I ~J~ ~ ~ J~~ FK eI ~ ~ ~ ~ ~ ~K

q ~ ~ ~ ~~~ ~ pkm ` E ~ ~ ^~w~Im~~~ `~ ~ ^~ _FK `~ ~ ~ ~ I ~ ~ ~ J ~ K eI OMMM ~ ~ ~ E F ~ ~ ~ ~I ~ ~ ~ ~ ~K

f OMMN p o ~ ~I ~ a t~ a~ ~`blK e ~ p K f ~ ~I r~d ~ ~ Ejpbh PMF ~ ~ ~ ~I K

^ ~ ~I r r SM ~ ~Ka ~ r~d ~

~ ~~~ ~K ^ ~ I ~ ~ ~ ~ ~ ~ ~ K q ~ ~ ~ ~K q ~~ ~~~K a~ ~ ~ ~ ~K _ ~ ~I r~d ~ ~ ~ ~ I~ ~ JK q ~I

~ ~ ~ ~ I ~~~ ~ E~ jpbh OMMFK

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g i~~Je~

q ~ ~ ~~ ~ ~I ~ ~I RM ~ ~~ ~K q ~ ~ ~ ~ ~ r~dI ~ ~ ~I ~ K q

~ ~ ~ K p ~ _~ ^~ p N g~~ OMMPI ~ ~ ~ ~ ~K b~ OMMOI ~ ~ ~ ~~I ~ ~ ~I ~ ~K eI ~ ~~~ ~J ~K

7.3 The present situation

a ~ ~ ~ ~ ~ ~ ~ Id~ e~~ ~ ~~ ~ ~ ~ ~

~ r~d ~ ~ ~K ^ I ~ Kq ~ ~ r~d ~

~~ K f ~ ~ ~ ~ ~ ~ ~ ~K q ~ ~I ~~ ~I ~~ ~K

8. Comparative analysis

^ I ~ ~ ~ ~ ~K _~ ~ ~ ~ I ~ ~ ~ ~ ~~~ ~ ~ ~K f ~I ~ ~ ~ ~ ~ ~ ~ ~K c ~ ~ ~~ ~ I ~ ~ I ~ I ~ J~ ~ ~ K

a ~ ~ ~ I ~ ~ ~ ~K

p ~~ ~ ~ N ~ K

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Table 1. Some facts about the commercialisation ventures

deCode Oxagen UmanGenomics

Type of biobanks a~J

k

a~J

k

m~J~

mJNumber of biobankingpartners

j~Ef~ ~F

^K PMEb~ ~~

F

lEq j~

_~F

Does the company have

own biobanks?v k k

Where are the biosamples

physically stored?` l~ q j~

_~

Does the company have

exclusive rights tocommercialise?

v E F v EOJR ~F v EOM ~F

Year of foundation NVVS NVVT NVVV

Number of employees (end

of 2002)^K QRM ^K NMM NS

Revenue (2001) jpbh OVMEjrpa POF

jpbh RMEjrpa RKRF

M

Net loss (2001) jpbh QPMEjrpa QUF

jpbh NOREjrpa NQF

K~K

Key industrial partners oj

^~w~m

Private/public company m m~ m~

University ownership k TB SMB

f ~ r~dI ~ ~ ~ ~ ~ ~~ ~ E RFK q~ ~ ~ ~

~K q ~ ~ r r ~ s ` `I r~d ~ ~ ~ ~ ~ ~ ~ ~K

r~d ~ ~ ~I ~ ~ ~ ~ L~ ~~~K q ~ E~ r rF ~ r~d ` ~ l~I ~ ~~ K _ ~ I r~d ~K

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g i~~Je~

Figure 5. Simplified illustration of UmanGenomics in its network

i r~dI l~ ~ ~ ~ ~ K _ ~ ~~ ~ ~ JK f ~ ~~ ~ ~ ~ ~I ~ ~J ~ I ~ r l q t qK l~ ~ ~ ~ ~ ~ ~ ~K c ~ ~ ~ ~ ~ ~~ ~ ~~ ~ rh~ ~~K q ~ ~I ~ ~ ~J ~ ~ K `~~ ~ ~ ~ PM ~~ ~ ~~ E SFK f ~I l~ ~ ~I ~~ K qI ~ r~dI l~ ~ ~ J ~K ^ ~l~ ~ ~~ ~ ~Kr~d ~ ~ JI j~ _~ E ~ ~ ~ ~ r~d ~ ~ J~ ~ ~FK

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Figure 6. Simplified illustration of Oxagen in its network

i l~I ` ~ ~ ~ ~ ~ I ~ ~~ K _ r~dI ~I ~ ~ ~ ~~ ~I ~ ~ ~ ~ K f~ ~ ` s ~ ~ ~ ~ ~ E OTMIMMMFK eI ~~~ l~I ~ ~ ~J ~ ~ ~ ~ `Kq ~ ~ ~ ~~ ~~ ~ ~ ~ ~ ~ ~ ~ E TFK ^ ~ ~ ~ ` ~ ~ I ~ ~ ~K q~ I` ~ ~ ~K kI ~ `~ ~~ f~ ~ ~ ~ ~~ ~ ~K

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Figure 7. Simplified illustration of deCode in its network.

q ~ ~ ~ ~ ~ PK t ~ ~~ ~ EF ~ ~ ~Kt ~~ ~ ~K

8.1 Conditions for access to biosamples

q ~ ~ ~ ~ ~ ~ ~ ~ ~J~ K ^ r~d ~ ~~ ~ ~ ~ ~ ~ K

c ~ ~ ~K f ~ ~I ~ ~ ~ ~I ~

~ K q ~ ~ ~L~ ~ ~ ~K f ~ `I ~ ~ ~ ~ ~ ~ ~ ~I ~ ~ ~ ~ ~ ~ K`I ~I ~ `K f ~ ~I ~ EKKI ~ ~ ~FK q~ ~ ~ ` ~ ~ ~ ~ ~ ~K f I ~ ~~KNP

NPf I ` ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ E ~ f~ e~ ^~FK f ~I

74


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`~ d `~ ~ _~

i `I l~ ~ ~ ~ ~ ~K q ~ ~I l~ K t ` ~ JI l~ ~ ~ ~ l~K q ~~ ~ ~

~ ~ E ~~ ~ l~ ~ F ~I ~~ ~I ~ ~ l~Kl~ ~ ~ ~ ~ ~ E~ ~F ~ ~ ~~K q ~ ~ ~ ~ ~ I l~ ~~ ~K f I I ~ ~I~ ~ J ~I l~ ~ ~ ~ ~ ~ K kI I~~ ~ I l~ ~ ~ ~ ~ ~ ~I ~ OJR ~ E ~ ~

FK ^~I ~ ~ ~ ~ ~~I ~ ~ ~ ~ ~ ~ ~ l~ ~ ~K

f rI ~I ~ ~ ~ ~ ~ ~ ~K q ~ ~ ~ ~ j~ _~I ~ ~ I ~ ~ ~ ~ ~K ^ ~~~ I ~ ~ ~ ~ rr ~ s ` ` ~ r~d ~ ~~K q ~ ~ ~ r~d ~K q ~ ~ ~ ~ ~ ~ ~ ~K c ~I ~~ ~ ~ ~ ~ ~ ~ ~ ~~~ K d~ ~ ~ ~I ~ ~ ~ ~ ~ ~ ~~ ~ ~ ~ ~K

q ~ ~ ~I ~I ~~I ~ ~ p I ~ I ~~ ~K q ~ ~ ~ ~~ ~

~ ~ ~ ~KNQ^ r~d ~ ~I ~

~ ~ ~ ~ ~ ~~ ~ ~ K c ~I ~ E pF ~ EKKI

` ~ ~ ~~ ~~I ~ ` ~

~~ KNQp tI pK OMMO ~ ~ ~ ~~ ~ K

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~~ ~ ~ ~ FKNR f ~ j~ _~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ KNS _ ~ ~ ~ ~ ~KNT_ ~ ~ ~K

f ~ ~ ~ ~ I ~ ~ ~ ~ ~~ ~ K q ~ ~~ ~ ~K eI ~ ~ ~K c ~I ~ ~~ ~ ~ ~I K q ~ ~ ~ ~ ~ ~ K f ~ r~dI ~ ~~ ~ ~ ~ ~ NIMMM I ~ SSIMMM ~ sfm FK eI ~ ~ ~ ~ ~

r~d ~ I ~ ~ ~ ~~ ~ ~ ~ ~ Kf I I ~ ~ K

q ~ ~ ~~~ ~ ~ ~ ~~~K f II ~ ~ ~ K f ~ ~ ~ ~ E~I ~~I F ~ ~ K

^ ~~ ~ ~ Kq ~ ~ ~ E~ ~F ~ ~ JNVUMK lI ~ ~ ~ ~ ~~K o ~~ ~K

d ~ ~ ~ ~ ~ ~~ pI ~ ~I ~ rI ` g b~`K q~ ~ ~ ~K

^ ~ ~ E~F ~ ~I~ ~ ~ ~ ~ ~ K f ` ~ l~ ~I ~ ~ ~ ~ ~ ~ E ~ FI

~K f rI ~ ~ ~

NRc ~ ~ I ~ ~ ~ ~~~I ~ ~ ~ ` ^K f ~ ~ ~ ~ I ~ I ~ ~ ~ EKK ~FK t~ ~~~ I ~ ~ ~ ~ ~ ~ ~ ~ K eI ~ ~ ~~ ~ ~ ~ K p e~I K EOMMOF ~ ~ ~ ~~ KNSe~I K OMMOKNT

q ~ ~ ~ ~ ~~~I ~ ~ ~~~ ~ ~ ~ ~~ ~~~ EI KKI e~I K OMMOFK

76


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`~ d `~ ~ _~

K q ~ ~ ~J ~K q r r ~ s` `K kI ~ r~dI ~ J ~I ~I ~ ~ ~ ~K l ~ ~ JJ ~ ~ ~

~ K q ~~~I I ~ ~ ~ ~ K

l ~ ~ ~ ~ p ~ ~ ~ ~ ~~ ~ ~K f ~~ ~ ~ ~ ~ ~ ~ ~~I ~I ~~ ~ ~ K lI ~ ~ ~ ~ I ~ ~ ~ j~ _~ rK ^r~ m~ ~ o~ c ~ ~ I ~ ~ ~ ~ ~ ~I ~ ~ ~

~ ~ ~ ~ ~K^ ~ ~ ~ J

~~ K f ~ ~ ~ ~ ~ ~ ~I ~ ~ ~ ~ K t ~ ~ ~ ~ ~ EI KKI~ NFK d ~ ~ ~ ~ I ~I I ~~ ~ K b ~ J~ ~I ~ ~~ ~ ~K l ~ ~ ~ ~ ~ ~~ ~ ~ ~ K q ~ ~ ~ K

_ ~ ~ ~ ~ ~ K cI ~ ` ~ l~ ~ ~I I~ K q r ~ K eI j~ _~ ~ ~ K r~d ~ ~ Ejpbh O ~F ~~ ~ ~ ~~K b I ~ ~K l ~ ~ ~~ ~ ~ r r ~ ~ ~ ~ ~~ ~~~ E ~~

r~dFK q ~ ~~~ ~~KkI ~ ~ ~ ~ ~ ~ ~KtI ~ rI ~ ~ ~ ~~ ~ ~ ~ ~ ~ I ~ ~ ~ ~ ~ E ~ FK q ~ ~ ~ ~ ~~ ~ ~ ~ ~I ~ ~ ~ ~ ~~ K t~ ~ ~~ I ~ ~ ~ Kl ~ ~

~ ~~ ~ ~ ~ ~~ Kq ~ ~ ~ ~

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~ K eI ~ ~ ~ ~ ~ ~ ~K q ~ ~ ~~~K f ~ ~ ~ K jIp ~ K

f ~ ~ ~ ~ ~ ~ ~J~ ~ rh ~ ~ ~ ~ ~K m~~~ ~ ~ ~ ~K _ rh _~ ~ ~ I ~~K q ~ ~ ~ ~ I ~ SJ ~ ~K

q ~I ~ ~ ~~ ~~ ~ I ~ ~ ~ ~ K t ~ ~~ ~ ~ ~ ~ ~ ~ ~ ~I ~ ~ ~K

q ~ ~ ~ ~ ~ ~~ K t ~ ~ ~ ~~ ~ K q ~ ~ ~ ~ ~~ K ^~I ~ ~K e ~ ~ ~\ r~dI ~ ~ ~ j~ _~I ~ ~ K f ~ ~ ~ ~ ~K^ ~ ~I r~d ~ ~ ~ ~ ~ ~~ ~~ ~ ~K eI ~ ~ ~ p ^ _~ e~ ~I ~ N g~~ OMMPK q ^ ~ ~ ~~ ~Kq ~ ~ ~ ~~ ~ ~ ~ ~~K l ~ ~ ~ ~ ~NU~ ~ ~~ ~ ~ ~ ~ ~K _ ~ ~ ~ ~ ~ ~ ~ ~ ~I ~ ~K eI ~~ ~J ~ ~ ~I ~ K

q ~ ~ r ~ ~ ~~ ~ ~ ~ ~ I ~

~ ~ ~K f ~ ~ ~ I ~~ ~ ~ ~ ~ K f ~ ~ ~ ~ ~ ~KNVq ~ ~ ~ ~ ~ ~ I ~

NU^ ~ ~ ~ ~ ~ J ~KNVjI ~ ~ ~ ~

~ ~ ~ ~ EKKI ~~ ~ ~ ~F ~ ~~ ~ E ~~ ~ ~ FK

78


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`~ d `~ ~ _~

~ ~ ~K eI ~ ~ ~ ~ ~ ~~ ~ ~ ~ ~ ~~ ~ ~K q ~ ~ ~ ~ E~F ~ ~ ~ ~ ~ ~~ ~

~ ~ _~ ^ p E~ q~~~^FK f ~ ~ ~ I ~ ~ ~ ~~ ~ ~ ~K qI p ~I ~ ~ ~I ~~ ~ ~ ~ ~K c~I ~ ~ ~ ~ ~ ~~I ~ K f ~ I ~I ~ ~ f~ ~ ~ ~~~K q~ I` ~ ~ ~ f~ ~~ ~~~K q ~ I ~

~~ ~ ~ K f ~ ` ~ ~I ~ ~ ~ ~~ ~ ~ ~ KOM

q ~ ~ ~ ~ ~ ~~ ~K q ~ p _~ ^I ~~ ~ ~ ~ ~ ~K o~ ~ ~ ~~ ~ ~ ~ ~ ~ ^K ^ ~ ~ ~ b~o ~ K

f ~ ~ ~ ~ ~I ~I ~ ~ K _ ~ ~ ~ ~ ~ ~ ~ ~ ~ I ~ ~~ ~K l~ ~ K

q ~~ ~ ~ ~ ~ ~K f pI ~I i~ d ^ ~ ~ ~ K ^ I ^ ~ ~ ~ ~ ~~ ~K q~ s ` ` ~ ~ ~ r~dK qp ~ ~ I ~ ~

~ ~J ~ ~~ ~ K r~ e ~ r~d ~K q ~ ~ ~ ~ r~ _~ ~ K f ~ ~~ ~I ~ ~~ r ~ ~ ~ KON

k ~I ~ ~ ~ ~ ~ ~ ~ ~ ~K q

OM

q J ~ ~ p _~ ^ ~ aI _K OMMMJMN ~ OMMNI ~ _~I rK OMMOKON_~I rK OMMO

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g i~~Je~

~ ~ ~I ~I ~ ~ ~~ ~ ~K

q ~ ~ ~ ~ KOO f ~ ~ j~ _~ ~ ~ ~ ~ ~~I ~ ~

r~dK q ~ ~~~ ~ ~ ~ ~~I ~ ~~ d `~ m~ Ed`mF ~ d i~~ m~ EdimFK f ~ ~ ~ ~ ~ ~ K `~ ~ ~ ~ ~I ~ K f ~ ~ ~ ~~ ~I ~~ ~ K qI ~ ~ ~ ~ ~ ~ K

t ~ ~ ~

~ ~I ~ ~~ ~ K ^ ~~ ~ ~K f ~ `I ~ ~I ~ ~Kf ~ j~ _~I ~ ~ ~ IKK I ~ ~ K d~I ~ ~ ~ ~ ~ ~ ~K _~ ~ ~ r~d ~ ~ K ^ r~dI ~ ~ ~ ~ ~ ~~~ ~K r~~ K q rh _~ ~ I ~ ~~ ~ ~K eI ~ ~ ~ ~~~ ~ ~ I ~ ~ ~ ~ K q ~ ~ ~ ~ ~ I ~ ~ ~ ~ ~ ~~ ~ ~~K

8.2 Protecting the donors integrity

r ~ ~ ~I ~ ~ ~ ~ ~ ~K p ~ ~ ~ ~ ~ ~~ ~ ~ K q ~

~ ~ ~ ~ ~ ~ ~~ ~~ ~K f ~~ ~~ ~ ~ ~ ~ ~ ~K m~ ~ ~ ~ ~K _ ~ ~I ~ ~ ~ ~ ~ ~ ~K` ~ ~ ~ ~ ~ ~ ~ ~K qI ~ I ~ ~~K q

OOi~~Je~I gK OMMPK

80


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`~ d `~ ~ _~

~ I I ~ ~ ~ ~ ~ K

` I ~ ~ I ~ I ~ ~ ~ K f f~I ~I ~ ~ ~~ K q~ ~

` E~ ~ ~F ~ ~ ~K ^ ~ ~ ~~~ ~ ~ ~~I ~ ` ~I ~ ~J~ ~ ~ ~~~ ~K q ~ ~ ~ K q ~ ~ ~ ~ ~ ~~ ~ ~ ~I ~ ~ ~ ~~ ~~~K

f f~ ~ ~

~ ~ ~~~ I ~ IOPI ~ ~ J~ ~ ~~ EKKI FK eI ~ ~ ~ ~ J~ ~ ~ I ~ ~ ~ ~ KOQ

b ~ K d ~ ~~ ~~ ~~ ~ ~ ~ I ~ ~ ~ K q~ ~ ~ ~ ~ ~ ~ ~ KORf ~I p _~ ^ ~ ~Kt ~ ~ ~ ~ ~ ~ ~ ~ ~ K q ~I ~~I K

t ~ ~ ~ ~ ~ ~ ~ K q ~ ~ ~~ UKNK

t ~ ~ ~ ~ ~I ~ `~ l~ ~ I ~ ~ ~ K _ J ~I rI ~ I ~K

a ~ ~ I ~ ~ ~ K j~ ~ ~ I ~ ~ ~ ~ ~ ~~ ~ ~ ~K f ~ ~ p _~ ^ ~K f ~

OPd ~ I ~ ~KOQ

^~I bK OMMOKOR^ e a~~I ~ NVSMI ~~ ~ ~ ~ K

81


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g i~~Je~

~ ~ ~ E~F~ ~ ~ ~KOS

f ~ f~ ~ ~ I K ^ I

~ ~~~ ~~ K cI ~ ~ ~ ~ ~ ~ ~ ~K _ ~ f~_~ ^ ~ ~I ~KOT

q f~ ~ ~ ~~ ~ ~~ ~ ~ ~ ~ ~ ~ ~ K f ~ ~ ~ ~ ~ ~ ~ ~ ~I ~ K

^ i~ o ~ ~ h i~ ~I ~ ~ I ~ p ~ ~ ~ ~ ~ ~K q ~ ~ ~ ~ ~~ ~ ~K

8.3 Organising the genomics company

q ~ ~ ~ ~ EF ~K q ~ ~ ~ ~ ~K ` ~ l~ ~~K f ~I ~ ~ ~ ~ ~ ~ ~ ~ J ~ ~ ~K l~I ~I ~ ~ ~ ~ ~K q ` ~ I I ~ ~ ~ ~ ~ ~K l~ ~ ~I ~ ~ ~ ~~~ ~ ~~ K

f ~I ~ ~~ I ~~ E ~ ~ ~ FK f ~ ~ ~ ~ ~~ K _ ~ ~ ~~ ` ~ ~ J~ ~~ ~

f~K f I ~I ~ ~ ~ Kq ~ ~~~ ~ ~K

r~d ~ ~ ~ j~_~I ~ J Kr~d ~ ~~ ~ J~ ~ r ~ ~ ~~ ~K ^ ~I ~ ~

OS^ ~ ~ ~ ~~~ ~~ ~ ~~ ~ Ei~~Je~I gK OMMNFKOT_ ~I ~ ~ ~ ~ E ~FK

82


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`~ d `~ ~ _~

~ ~I ~~~ ~ ~ ~ ~K ^~I ~ ~ ~ ~ ~ K

j~ ~ r~d ~ ~ ~ K q ~ J~ ~ rK _

J ~ ~ ~ ~ ~~ ~ ~ ~ ~ J~ ~ ~ ~ p E~ ~ ~~FK q ~ ~ ~~ ~ r~dK q ~~ j~ _~ ~L K p ~ ~~ ~ ~ ~ r ~ ~ ~ ~ ~ ~ J~K _ ~ ~~ ~ ~ ~ ~~~ ~ ~ ~ ~ ~ ~~ ~ ~~~ ~K

f ~ ~ ~ ~ I ~ ~ ~ ~~K q ~ ~ ~ ~~ ~ ~K iJ ~ ~ ~ ~ ~ ~ ~ ~ ~K f I ~ ~ ~I ~ ~ ~ ~ ~ ~ ~ ~ ~ J~~K q ~ ~ ~ ~K

t ~ ~ ~ ~ ~ ~ ~ ~ ~ ~I ~ ~ K q ~ ~ ~ ~ K d ~ ~~~ ~ ~K

` ~ ~ ~ ~ ~I ~ ~ ~ E ~ NFK f ~ ~ ~I ~ I ~ ~ ~ ~ ~~ ~ ~ ~~ oI ~ ` ~ ~K r~d ~ ~I ~ ~ ~ ~ ~ ~ ~K cI ` ~ l~Ir~d ~ ~ ~ ~

K t I ~ ~~ K t ~ ~ ~ I ~ ~ ~ ~ ~ K t~ ~ s` ~ ~ ~ I KK ~ ~ I ~ ~ ~ K ^ ~ I I ~ ~ j~ _~ ~ ~ I K q ~ ~ ~ ~I ~ ~ K f ~ ~~I ~ ~ r~d ~

~ ~ I ~ K q ~ ~ ~ K

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g i~~Je~

g ~ ~JI ~ ~ ~ ~ ~ ~K d~ ~I ~~ ~~ ~ ~ ~~ ~K f NVVMI ~ ~ I ~~ s` I ~~ ~ K q I ~ ~ ~~ ~

I ~ ~ ~~ ~ ~ ~ ~~~ I ~ ~ ~ ~ ~~K q ~~ ~ ~ K f ~ ~ ` ~ l~ K q ~I ~ ^~ s` ~I ~~ ~ ~ K

q~I ~ ~ I ~ ~ K f ~ ~ ~ ~ ~~K _ ~ s` ~ ~I ~ ~ ~ ~ ~ K q

~ ~ ~ I ~ ~ ~ I ~I ~ I~ ~~~ ~ ~ ~ ~ ~J~ K f~ ~~ ~ ~ ~ ~I KK ~ ~ ~ ~~ K

q ~~ ~ ~~ ~I ~ ~ ~ ~ I ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ s`~K

^~ ~~ ~I ~ ~ ~K c ~I ~ ~I ~ I ~ ~\^~ K q ~ ~ ~ ~ ~ K f~ I ~ rK ^~ ~ I ~ ~ ~I ~I ~ ~ ~~ I ~ ~ ~I ~ ~ ~ ~ E UKNFK

eI ~ ~~ ~ I ~ r ~ f~ ~I ~~ ~ ~K q ~ ~~ ~ ~ ~ ~ ~ ~ J~I KK ~ K _ ~ ~ ~ ~ K m~ ~ ~I ~ ~ K

f ~ E~F ~ ~~ ~I ~ ~ ~ ~ I ~ ~ ~~ E QFK qI ~ ~ ~

~ ~ ~ ~ ~ ~ E ~ ~I ~ ~

84


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`~ d `~ ~ _~

FK ^ ~ I ~ ~ ~ ~ ~ Kf ~ `I ~I ~ ~ ~ ~ ~ ~ ~ f~ rpK c ~ I rp

~K eI f~ I ~ ~ ~ ~~ ~ I ~ ~ f~K

8.4 Organising the biobank unit

e ~ ~ ~ I ~ ~ ~ ~ ~ ~ ~I ~ ~~ ~ I ~ ~I ~ ~ ~ ~J~I ~ ~ ~ ~ ~ ~ K q ~ ~~~ ~

J ~ ~J~ ~ ~ ~~ ~ ~~K f ~ ~I ~ ~ pI ~ ~ ~ ~ ~I ~I ~ ~ J~ ~ ~K

k ~ ~ ~ ~ ~ ~ ~ ~~~ ~K c ~I _~ ^ p ~ ~ ~ ~ EKKI F ~K q ~ ~ ~ ~ ~ ~ ~ I ~I ~K f ~ ~ ~ ~ ~ ~ ~ ~ K

q ~ ~ ~ ~~ ~ ~ ~ ~ K q ~ ~ ~ ~~K f ~ ~I ~~ ~J~K ^~I ~ ~J~ ~~ ~ K _ ~I ~ ~ ~~ ~ ~ ~~ ~ ~K

^ ~ ~~ ~I ~ ~ ~~ ~ ~I ~ ~~ ~ E ~ ~I

~~ ~I ~ ~ FK l ~ K ^ ~ ~~ ~ ~~ ~I ~ ~ ~I I ~K _ ~~ ~ ~ ~I ~I ~ ~ ~ ~K q ~ f~I ` ~ ~ ~ ~ ~~ ~ ~ ~K q I I ~ ~ I ~ ~ ~Kq ~ ~J~ ~ ~ J

~~ ~~K t ~J ~ ~ ~ ~ E ~JF ~K ~ ~

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g i~~Je~

~~~ ~ ~ ~K f ~ ~ ~ ~K _ l~ ~ ` I ~K q ~ ~ ~ I ~ ~ ~ I ~ ~~ ~ ~ ~ E~ ~I ~ ~ ~

~FK cI ~~ ~ ~ ~~K f ~I I ~ ~ ~~K

q ~ ~ ~K f ~ ~ ~~ ~~ ~ ~I ~ ~K _~ ~ ~ ~ ~ ~ ~ ~ ~K p ~ ~ ~ ~ ~~~I ~ ~ ~ I KK ~I ~ ~ K _ ~ ~ ~ ~ K

c ~J~ ~ ~~~ ~K r I ~ ~ ~ ~K qI ~ ~ ~ ~~~ ~ K f rhI ~ ~~ I ~J~ ~ ~ ~ ~ ~ ~ K b~ ~ r ~ ~ ~ ~ ~~K

^ ~ j~ _~ rI ~ ~ I ~ ~ ~~K eI ~ ~ ~ ~~K f ~ ~ ~ ~ ~ ~ ~~K d ~ ~I ~ ~ ~ ~ ~I ~ ~K f ~ ~ ~ ~ rI ~ ~ ~ ~ ~ ~ ~ ~~ K

b ~ ~ j~ _~ ~~~~~ ~ K ^ ~ ~~ I r~d~ ~ ~ ~ ~ ~I ~ ~ ~ ~K d~ e~~ ~ ~ ~~~ ~~ I ~ ~ ~ ~ ~K q~ ~~~ I ~ OUI ~ ~

~ ~ I ~ ~ ~ ~ I ~ ~K cI ~ ~ ~ ~ ~~ ~K f I ~ ~ ~ ~ K f ~ ~~ ~~ ~ ~ ~K f ~ I ~ ~ ~ ~ ~ J~ ~~ ~ ~ ~~~ K ^ ~ ~ ~ ~I ~ ~ ~ ~ K

OUi~~Je~I gK OMMPK

86


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g i~~Je~

~ ~ ~ ~K d ~ ~ ~ ~ ~ I ~ ~ ~ ~ ~ ~~ K qI ~ ~ ~ ~~I ~ ~

~ ~K

88


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`~ d `~ ~ _~

References

^~I b~ EOMMOFK m~ f~ f~ e~ p a~~~Kg~ f~I i~ ~ qI OK

_~I r~ EOMMOFK h ~ ~ E`~ ~ ~ ~~ ~ ~FK c~ i~I r~~ r EFK

aI _ EOMMMJMNFK e~ ~~ Ee~ ~~~ ~ FK g I kK QI K TTPJTUVK

aI _ EOMMNFK m ^~ q~ e~ q mK fe~I j~ dK EbKF EOMMNFK q r e~ _~W b~I p~I b~ ~i~ ^K r~~W r~~ rI K UPJUSK

b C v EOMMOFK _ _W q d~ _ o OMMOK

e~I ~ EOMMOFK _~ ~~ Eq ~ ~ ~ FK a~ i~I p r EFK

i~~Je~I g EOMMN~FK q f~ r _~ pW ~ lK fe~I j~ dK EbKF EOMMNFK q r e~ _~W b~I p~I b~ ~i~ ^K r~~W r~~ rI K NRJPQK

i~~Je~I g EOMMNFK h~ ~ ~ ~W E`~~ p ~W ~ ~ FI fjfqJo OMMNWNONK pW f j~~ f~ ~ q

fjfqFK

i~~Je~I g EOMMPFK `~~ _~W ^ p _ `~a~ e~ dEFK

o eEOMMMFK q d d~I ^I K PTMK

oI e~ EOMMNFK q `~ _~W q f~ e~ pa~~~K iW q t qK

tI p~~ EOMMOFK _~ ~ ~~\ Eq ~ ~

\FK a~ i~I p r EFK

89


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g i~~Je~

90


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m~ ~

R

Public law aspects on the use of biobank samples privacy versus the interests of research^~ m b~ o

a~ i~I r~~ r

f `~KI ~ ~

~K q ~~ ~ ~ I ~ ~ ~I ~ ~ ~ K q p _~ Ee~ `~F ^EOMMOWOVTF ~~ ~ ~ ~~~I ~ ~ ~ ~~K ^ ~~ ~~ ~ ~ ~ K f ~ ~ p ~ ~ ~ ~ ~~I~ ~ ~ ~~~K cI ^ ~ ~ ~ ~ ~~ ~ ~K f ~ ~ ~ I~ ~ ~ ~ br K

1. Introduction

^ ~ ~ I ~~~ ~ ~ ~ ~ ~~~ ~ ~ K p ~ ~ ~ I ~ ~ ~KNf ~ ~I ~ ~ ~ ~ ~

~ ~~K e~ ~ ~~I I ~ ~ ~ ~~~ ~ ~ ~KcI ~ ~ ~~ I ~ ~ ~ ~~ ~ K k ~ ~ ~~ ~ K kI ~ ~ ~~ ~ ~ ~ ~K f I ~ ~ ~~ ~ ~ I ~ ~ ~ ~ ~~ ~K

a I KK ~ ~~I ~ ~K f ~I I ~

1Cf. Hermern, G. 1997, p. 23.

91


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b~ o

~ ~ ~ JJ KOp ~ ~ ~ ~ ~~K pI ~ ~~ ~ I ~~ ~I ~ ~ ~~ ~KPi I ~ ~

~ ~ ak^ ~K ^ ~ ~~ ~ ~ ~ ~ ~ ~KQ

l ~ ~~ ~I I ~ I ~ ~ ~ ~K n I ~ ~ ~ ~~ ~~ ~ ~ K e ~~II ~ ~ ~ ~ ~ ~~ ~~ I ~ ~~ ~ ~~ K b ~ ~ ~ ~ ~ ~I ~ ~ ~ ~ ~

~ Kf I ~ I ~ ~ ~~ ~ ~ ~K ^ ~ ~ ~~ ~ ~ I ~ ~ ~ ~ K

q ~ ~ _~ m ~ ~ ~ ~ I ~ ~ ~ ~ I ~ ~ ~~ ~~ ~ ~

p ~KR

q ~ ~~ ~ ~~ p ~ ~~ ~I ~ ~ ~~ ~ ~

~ ~ ~ I ~ k K a ~ ~I I ~ ~~ p ~ ~KS

2. Some rights and interests to consider

2.1. Rights and interests of potential donors

r ^ U b~ ` m e~ o~ c~~ c ENVRMFIT ~ ~ K q ~ ~ ~I ~

~~ ~ ~ ^ b~` e~ o ~ _ ENVVTFKUq ~ ` ~

Op ~ o~ ~I ~ ~I ~ p j~ o~ ` EjcoF g NVVVKPp p O k~ ~I lK K RS EOMMNJOMMOFKQp ~ bdb NVVUKRp f W oI bK OMMNKS^ I p ~ OMMPKT ` b NVRMK ^ ~ ~ ~ ~ p ~X i~ ENVVQWNONVF

~ ~ ~ ~ ~~KU` b NVVT ~K

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m~ ~

~ ~ ~ ~ ~~~ I ~I ~ ~ ~~ ~ ~~ ~K q ~ ~ ~ ~~ br~I ~ a VRLQSLb` ~ ~~K ^

~ ^ P `~ c~~ o b~ r EOMMMFIV ~ ~ ~ ~ ~ ~ I ~ Kf~ ~ ~ ~ ~ ~ ~I ~ ~ ~ ~ ~ ~ ~ ~ ~~ ~KNM

^ ~ ~ ~ ~~ ~ ~~ ~~K q ~ ~ I ~I ^ P ` e~ o ~ _ ~

^ PR br `~ c~~ oK ^ ~~ ~ ~ I ~ ~ ~ ~ ~ ~K cI ~ ~ ~ ~ ~ ~ ~ ~ I ~ ~ ~K b I ~~ ~ ~ ~ ~ ~ ~ ~ ~~I ~ ~ ~ ~ ~ ~ ~ ~ ~ I ~ ~ I ~ ~~ ~ ~ ~ K

2.2. Rights and interests of researchers and industry

o~ ~ ~ ~K q ~ ^ NP br `~ c~~o ~ c ~ ~ ~ ~ p ~KNN f I ~ ~ ~ ~ ~~I ~ ~ ~K l ~ ~ ~ ~ ~K t ~ ~ ~I ~ ~ I ~ ~ ~ ~~ ~ p`X `~K OI p N c m ^K g

~ ~I I ~ K f~ I ~ ~ ~ ~ ~ K f ~ ~ ~~ ~ ~ ~ ~~ ~

V^ b~ `I I `~ ~ ~ KNMo ~ ~ ~ ^ UKN b~` e~ o ~ c~~ c ~ ~ ~ ~ ~ ~ ~ ~~ I ~ J I I

~ ~I ~ X ^ UKOK q ~ ~~ ~KNNp `~K NI p S e~ENVVOWNQPQF E e b~ ^FK

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b~ o

I ~ ~ ~ ~ ~ K

cI ~ ~I ~ ~ ~ ~ K o~ ~ ~ ~ I ~ ~ ~

~I ~ K `~~ ~ ~ ~~ ~ ~I J~ ~K

f ~ ~ ~ ~ ~ ~~ ~ ~ INO ~ ~ ~~ ~ K `~ ~~ ~ ~ ~~ ~I ~~ ~ ~ ~ K q ~ ~ ~ ~ ~ K f ~I ~~ ~

a VULQQLb` ~ ~ K pI ~ ~I ~ ~~ ~ ~ ~~ ~ ~K ^ NT br`~ c~~ o ~I ~ ^ N ^~ m N b~ ` e~ o ~ c~~ cKNP

2.3. The interests of society

f ~ ~ ~ ~ K q ~ I ~~ ~ ~ ~ ~ ~~ ~ K q~ ~ ~ I ~ ~ ~ ~ ~~~ ~ ~ ~ ~ ~ K q ~ ~~ ~ I ~ ~ ~~ ~ ~ ~ ~ ~ ~ ~~K

t ~ ~ ~I ~ ~ ~ ~ K q b~ ` e~ o ~ _ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ KNQ `~ ~I

~ ~ ~~ ~ ~ ~ I ~ ~ K p ~ ~ ~ ~ ~ ~ ~~ ~ ~K

2.4 The balancing act

^ ~I ~ ~ ~~ ~~ ~ ~ ~ ~ ~ ~ K f I ~ ~

NO

tI iK C mI ^KeK OMMNI K TTKNP` b NVROKNQm~ `K

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m~ ~

KNRc ~I ~ ~ ~ ~ ~ ~ K o I ~ ~ ~ ~ ~ I ~ ~ K q ~ ~ ~

~ ~ K p~ ~ ~~ ~ I ~ ~ ~ K f ~~ ~ I ~ ~~ ~ ~ ~ ~ ~ ~ ~ ~ I ~ ~ ~ ~ ~ X ^ NT b~ ` e~ o ~ c~~ c ~ ^ RQ br `~ c~~ oK

d~~ ~ ~ ~ ~~ ~I ~~ ~~ ~ ~~ ~ ~ I

~ ~ ~Kq ~ ~ ~ ~I ~ K ^ ~ I I ~~ ~ ~ ~K f ~ ~ ~I ~ ~ ~ ~ ~ ~ ~ ~~ ~K q ~ ~ ~ ~ J ~ ~ K q ~ ~ ~ ~ ~ ~~ ~ ~K

f~ ~ ~ J~ ~ ~ ~ ~~ ~ ~ I ~ ~ ~ Ka ~ ~ ~I ~ ~ ~~K c ~I ~~ ~ ~ ~ ~ I ~ I ~ ~ ~~ ~K cI ~ ~ ~ ~I ~I ~ ~ ~ ~ ~ ~ K b~I ~ ~ ~

~K^ ~~ ~ ~

~ ~ I ~ ~ ~ ~ ~ ~K q ~~ ~I ~ ~ ~K ^ ~ I ~ ~ ~~ ~ ~~ ~ ~~ ~ ~K q ~~ ~ I ~ ~~ ~ ~K

NRpI ~I pI eK OMMOI K SQJSUK

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3. Recent legal developments

3.1. European law and other international regulations

t ~ I ` b ~ ~ K q ~ ~

b~ ` e~ o ~ c~~ c ~~~ I ` ~ ~ ~ ~ ~ ~ ~~K j ~ ~ ` e~ o ~ _I ~ ~ ~~KNS^ O ` ~ ~~ I ~ ~ ~ ~~ K ^ I ` ~ ~ ~ ~ ~I ~ ~ ~ ~ ~~~K q ^ OO ~ ~ ~ ~ ~ ~

~ I ~ ~ ~ ~ ~ ~ ~~ ~ ~ K r ^ OSI ^ OO ~ ~ ~ ~ ~~ ~I I ~ ~ K k ~ ~ ~ ^ ONI ~ ~ ~ ~ ~ ~ I ~ I ~~ ~K

^ ~~ `I ~ ~~~ ~ ~ ~ I ~ ~ g~~ OMMOKNT p m ~~~ ~ ~~~ ~ ~ I ~ ~~I~ ~ ~I ~ ~ ~ ~ ~ K q ~~ ~ ~~ ~KNU q I I ~ ~ ~ KNV^ ~~I ~~I ~ ~~ ~ ~~~I ~ b~~ o ~ ~ ~~ ~ ~ m ~ ~I ~~I~ ~ ~~ ~ ~KOMf ~ b~~ o ~ m ~ ~

~ ~~~I ~ ~ ~ KON

NSq ` N a NVVVI ~ ~ pKp ~ b~~ oI ` b NVVS ~ oI bK NVVTKNT` b OMMOKNUp ^ P ~ ONJOOKNV`~K fff mK f ~ ~~ ~ ~ ~~ ~~ ~~ ~ ~ ~~~ ~ ~ ~ X p TU b~~ o mI `

b OMMNKOM` b OMMNI p OSKON` b OMMNI p QOK

96


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m~ ~

^ ~ ` b ~ ~ ~ ~ ~ ~~~ ~ ~ ~ JJ~ KOO f ~ ~ ~ ~~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~ ~~ ~I ~ ~ ~

~K f ~ NVVMI ` b~ ~ ~ ~ ~ ~~ ~ ~ ~ ~ ~ ~ ~KOPo~I o~ EVTFR ~ ~~KOQ

i ~ b~ ~ ~ ~ I b~r ~ ~ ~ ~~K ^ ~ ~ b` ~ ~ ~ ~~ ~ ~ ~ ~ ~IOR ~ ~ b` ~ ~ ~ ~ K ^ ~

~ ~ ~ b~ d b p ~ kq EbdbF NVVUK q bdb ~ ~ ~~ ~ ~ I ~ ~ I ~~ ~I ~~~ ~ ~~ ~K f ~ ~ ~ J ~ ~~I ~ ~ ~ ~ ~ ~ J~~K q bdb ~ I ~ I I ~ I ~I ~ K k ~I ~ ~ak^ ~ ~KOS

f ~ ~ ~ ~ ~ I ` ~ ~ ~ ~ ~ a ~~ ~ ~ ~ ~I I I I ~ ~ ~ ~ KOT i bdb I a ~~ ~~ ~ ~~ ~ KOU t ~I ~ ~ ~ ~~ ~ ~ ~ E~I ~ F ~I ~ ~ ~~~I I ~I ~ ~

~KOV

b ~ ~I ~ ~ I ~ K cI j p~ ~ ~~ ~ ~ I ~ K q ~ ~ ~ ~ ~

OO` b NVVQKOP` b NVVO ~ ~ NVVO K p ~ eI NVVTI K PTTPTUKOQ` b NVVT KORpI ~I a VRLQSLb`X a VULTVLb` ~ a OMMNLOMLb`KOSbdb NVVUI K OKOTm~ ~ a b~ m~~ ~ ` ~~ ~

~ ~ ~I I I ~I ~ ~ ~ KKOU^ N aKOVp e~ ~ OMMOK

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~ ~ ~ ~K p ~~ ~ I ~ ~ ~ ~ K l ~ ~ ~~ ~~ ~~ ~ I ~ ~ ~~ ~K

l ~~ I ~ ~ ~ ~ ~ ~ ~K q rkbp`l r~ a~~ e~ d ~ e~ o ENVVTF ~ tel m~~ ~ ~ ~ ENVVTFK kJ~ ~~ ~ ~~ ~ ~ ~I PM ~ ~~ ~ ~ ~~ ~ ~K

3.2 Domestic law

t ~ ~I ^ ~ ~ ~ ~

I ~ ~ ~~ ~ K jb~ I I ~ ~ ~ ~ ~~ ~ ~ ~K q ~ ~ ~ ~~ ~I ~ ~ ~ ~~ ~ ~ ~ ~ ^K a ~ ~~I ~I ~ ~ ~ I ~~I ~ ~~ ~ ~ ~ ~K

q k ~ ~ ~ ~ ~ ~ ~~ ~ ~ ~K f~ ~ ~ ~ _~ ^ ENNMLOMMMFK q N g~~ OMMNK f p ~ ~I cr e~ l~ ~ q Ej~ mF ^ ENMNLOMMNF IPN ~ ~I ~ ~ K q p _~ Ee~ `~F ^ EOMMOWOVTF ~ ~ j~ OMMO ~ ~ N g~~ OMMPKPO k~ ~ f~ ~ p ~I ~ _~ ^ k~ m~~ g~~ OMMPKPPq a~I ~I ~ ~ ~ ~I ~ a~ i~ p~ m~ ^KPQ

f ~ ~ ~ ~ I ~~ ~ ~ ~ ~ ~ ~ J~ ~

~~I ~ ~~ ~ ~ ~~ ~~ ~ ~K k ~ k ~I ~ ~I ~ ~I ~~ ~K

PMc ~ X I ~I ` o KPNi~ ~ ~ ~ ~ ~ ~ ~ OKOKOMMNLNMNKPOi~ EOMMOWOVTF ~ J KKPP

l K RS EOMMNJOMMOF ~p~ f lkK RO EOMMOJOMMPFKPQo ~K c~ ~ ~ OMMOK

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4. Human biological material a carrier of personal data

4.1. General remarkst ~ ~ ~ ~ ~ ~~I

~I ~~ ~ ~I ~ ~ ~ ~~ ~ K f ~ ~ ~I ~ ~ ~~ ~ ~~~KPRm~ ~ ~~ p _~ Ee~ `~F ^~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~ ~ ~ ~~ ~ I ~ ~ ~ ~ ~ ~ ~ ~ ~~ ~ ~KPS

4.2. Swedish law on the protection of personal data in relation to biomedical researchq ~ p ~ a VRLQSLb` ~ ~~ m~ a~~ ÎPT m~ a~~ l~KPU p~ ~ ~~ ~ ~ ~ ~ ~I ~ j~ `~ o^ ~ e~ a~~ o ÎPV ~ ~ ~~ K q ~ ~ ^ o~ o cm~KQM q ~ ~ II ~ ~ p ^ KQN

j~ ~ ~ I ~ ~ ~ ~~I ~ ~ KI ~

`~K O p c m ^K QOa~~~II ~ K ~ ~ K _~~I I c m Î~ ~ KQP q ~~ ~ ~ ~ ~ ~ ~I I ~ ak^ ~ ~ ~ ~ ~~ ~ ~ ~ ~ ~ K

q ~ ~ ~ ~ ~ ~~ ~ ~~ ^ ^ ~ ^ l~I ~ ~ ~ ~

KQQ

cI ~ I

PRp oI bK NVVUKPS^~I eJl ~ OMMOKPTm~ ENVVUWOMQFK q~~ ~ ~~ ~ ~ ~~ ~ ~~X ~~ PKPUm ENVVUW NNVNFPVi~ ENVVUWRQQF ~~ ENVVUWRQPF ~~KQMi~ ENVVVWPRPF ~ KQNp~ ENVUVWNMMFKQOq Ehh NVQVWNMRFKQP

o p ^~ Ì o NVVQ QSRKQQ^~ ENVVMWTUOF~^ ENVVNWQQSFK p o~ ~ ~ ~ ~ ~~ ~~ K

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~ ~~ ~ ~ X `~K OI p NO c m ^K

p NP m~ a~~ ^ ~~I KK ~I I ~ ~ ~

~K q ~ ~~ ~~ X p NQK m ~~ ~~ ~ ~ ~ ~ I ~ ~ ~ ~I ~ ~I ~ ~ ~I ~~ ~ ~ ~ ~ X p NUK

q ~ ~ ~~ ~ ~ ~ K l ~I ~ ~~ ~ ~ X p V j~ o ^KQRq ~ ~ ~ ~ ~ ~I ~ KX p OJPK f ~ ~

~~ I ~ I ~ ~ ~ ~ ~ ~ ~ ~ KQSq ~ ~ ~J~ ~ ~~ ~~~ ~ ~~I ~I ~ ~ ~ ~ ~ X p S e~ a~~ o ^K

t ~J~ ~ ~ ~~I I ~ ~ ~ ~K f ~I ~ ~ ~ ~L~ I ~ ~~ ~ ~ ~~ ~ ~~ Kp ~ ~ ~ ~~ ~~ ~ ~ K k ~ ~ ~~ ~ ~ ~ ~ I ~ ~ ~ ~ ~ ~ ~KQT

t ~~ ~ ~I ~ ~ ~ ~ ~ ~ ~ ~ ~~ ~ ~ I ~ X `~K TI p N ENF p ^Kp~ ~ ~ ~ ~X `~K OI p U e~~ j~ p Em~ ^F ^ ENVVUWRPNFK b ~

~ ~ ~I ~ ~ ~ ~K q ~ ~ ~~ ~ ~~ ~ I ~ ~ ~~ ~ ~ ~ ~ ~ ~ I ~ X `~K VIp Q p ^K

QRm~~~ ENVUSWOMPFKQS

p ~~ ~ ~ j~ `~ o ^I ~ ~KQTp ~ `~K NI p Q p ^K

100


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m~ ~

f ~ ~ ~ ~I ~ ~ ~ ~ KQUq ~ ~ KQV f ~ ~ ~ ~ I ~ ~I ~ ~

~ ~ ~ ~KRMf ~ ~ ~ I I ~ ~ ~ K RNb~ ~ ~ ~ ~I ~ ~K f ~I I ~ ~~ ~ ~ ~~KRO f ~ ~ ~ ~ ~ ~ ~K

p NV ENF m~ a~~ ^ ~ ~~~ ~ ~ ~ ~

~~ I ~ ~ ~ ~ ~ ~ ~ ~~ K q ~ ~ ~ ~ ~ ~ X OK^ ~ ~ ~ ~~ ~ ~ ~ I ~ ~ ~ ~ ~ ~ ~ K q ~ ~ ~~ ~ ~ ~I ~ ~K

k~ a~~ f _~I ~ ~ ~~I ~ ~~ ~ ~ ~ ~~~ ~ _~X p PT m~a~~ ^K k ~ ~~ ~ KRPm ~ ~~ ~ ~ I ~~ p NU m~ a~~ ^I ~ ~~ p PSKRQ

eI ~ ~ ~ a~~ f _~ ~~K p ~ ~ ~ ~~KRRq ~ ~ ~~ ~ ~ ~

~ ~ I ~~ p NV m~ a~~

QUt I ~ ~ ~~ ~ ~ ~ `~K NRI p SJU p ^KQVoI dI b~I j C e~I pK OMMO K fffWNQJNRKRMc ~ ~ ~ ~X ~ r b KRN`~K NQI p Q ENF p ^KROoI bK OMMPKRPq p Q a~~ f _~ ` p~Ia~~ Eafcp OMMNWNF ~ a~~ ~

~ ~~ ~~ ~ a~~KRQp R EF ~ ~KRRp p NM m~ a~~ l~I p QN m~ a~~ ^K

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^K f ~~ ~~ I ~~ KRSq ~ ~ ~~ ~ ~ ~ ~ K m ~ I I ~ ~I ~

~ ~~ ~ I ~ ~~ ~~ ~K

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4.3. The status of biobank materialseI I ~ ~ ~~ ~ brLbbÎ a VRLQSLb` ~ ~~ \ t ~ ~ ~ ~ ~ ~~ ~ ~ ~~I ~ ~~ ~ ~ ~~ ~ ~ ~ ~ ~K f ~ ~ ~ ~ aVRLQSLb` ~ j p~I ~ ~ ~ ~~ ~ ~ ~ j p~I ~~ ~ > q ~ ~ ~ j p~ I I ~ ~ ~KRUf ~~ ~ ~ ~ ~~ ~ ~ ~~ ~ ~~K q ~ ~ ~ ~ ~ ~~ ~ KRV

l ~ ~ ~ ~ ~ ~ ~~ ~ ~~ ~ a~KSM q ~ ~~ a~ ~ ~ ~ ~~I ~ ~ ^K

RSr p P b o Î I ~ ~~ ~J~ ~ ~~ X d _o OMMOLMPWRM b ~ K q~~ ~ ~~ ~~ KRT~I pK C iI eJlK OMMOI K NOSKRUp k~~ b ` ~ I ~ ~ ~~~ ~ ~ ~K OMMOKRVq ~ ~ ~ b~ ~ mofsfobîW m~ o~ b ~ i~I J~ m a _ ~ a~ q ~ pf_ibI

p rK f~ ~ ~ YWLLK~KL[KSMp KK _I mK NVVSI K OVJPQ ~ b ~ o ~K c~ ~ ~ K OMMO K OQRK

102


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f ~~ ~~ p m~ a~~ Î ~ ~ KSN q p d ~ ~ ~ ak^ ~ ~ ~ ~ ~ ~~I ~ ~~ ~ ~ ~ KSO q d ~I I ~

~ ~ J~ ~ ~ ~~ ~~ ~~ ~ ~ m~a~~ ^K p ~ ~ ~~ ~I ~ ~~ ~ ~ ~ ~ ~ a VRLQSLbÌ ~~ _~ Ee~ `~F ^ K ^ ~ ~~ ~ ~ ~ ~I ~ ~ ~~ ~ ~ KSP

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Biobanks as a resource

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