Ethical issues in tissue banking for research: a b

KEITH BAUER, SARA TAUB and KAYHAN PARSI

ETHICAL ISSUES IN TISSUE BANKING FOR RESEARCH:A BRIEF REVIEW OF EXISTING ORGANIZATIONAL

POLICIES

ABSTRACT. Based on a general review of international, representative tissue

banking policies that were described in the medical, ethics, and legal literature, thispaper reviews the range of standards, both conceptually and in existing regulations,relevant to four main factors: (1) commercialization, (2) confidentiality, (3) informedconsent, and (4) quality of research. These four factors were selected as reflective of

some of the major ethical considerations that arise in the conduct of tissue bankingresearch. The authors emphasize that any policy or ethical guidelines designed toregulate tissue bank research should address all four factors. Whenever this sort of

research is conducted between several institutions or several countries, the papersuggests that the relevant entities work collaboratively to harmonize their standards.

KEY WORDS: commercialization, confidentiality, human tissue sample, informedconsent, organizational policies, quality, research, standards, tissue banking

INTRODUCTION

Tissue banking research increasingly is conducted in partnershipbetween the for-profit and not-for-profit spheres, raising many ethicalconsiderations.1 In part, this change can be attributed to the growingsophistication of genomic technology and, in particular, the newinterest it has fueled in human tissue.2 In fact, newly established tissuebanks are surfacing – many of them private, for-profit enterprisesthat compete with non-profit tissue banks for the recovery and pro-cessing of these tissues.3 In addition, tissue banks in the non-profitsector are often supported by the pharmaceutical and biotechindustries that help fund academic research and rely on human bio-logical samples recovered and banked by these institutions.4 Somecontend that the current system of safeguards (at least in the US) willbecome increasingly obsolete in protecting tissue donors; others pointto a variety of cultural, organizational, and professional issues thatquestion the ethical appropriateness of for-profit tissue banks and

Theoretical Medicine 25: 113–142, 2004.� 2004 Kluwer Academic Publishers. Printed in the Netherlands.

academic-industry relationships.5 In response to these concerns,various governments, non-governmental organizations, and otherinstitutions have been drafting and promulgating policies to regulatetissue banks and their relationships with industry. These policiesrepresent the consensus of private associations (such as the AmericanAssociation of Tissue Banks), reflect the national policies of certaingovernments (such as Spain), and are the products of various inter-national bodies (such as the European Union). Thus, these policiesare broad in scope; we have not surveyed the institutional policies ofindividual banks, academic medical centers, or other institutions.Moreover, the enforcement mechanisms will similarly reflect theauthority of the bodies that produce such policies. For instance, aprivate association will have relatively little authority to sanctionindividual banks for violations of certain policies; on the other hand,governments will have appropriate enforcement mechanisms to en-sure compliance (although resources to achieve such compliance willvary from country to country).

Based on a general survey of representative tissue banking policiesthat were described in the medical, ethics, and legal literature, thispaper reviews the range of standards, both conceptually and inexisting regulations, relevant to four main factors: (1) commerciali-zation, (2) confidentiality, (3) informed consent, and (4) quality ofresearch (see Table 1). These four factors were selected as reflectiveof some of the major ethical considerations that arise in the conductof tissue banking research.6 We recommend that any policy or ethicalguidelines designed to regulate tissue bank research should address allfour factors. Where this sort of research is conducted between severalinstitutions or several countries, we suggest that the relevant entitieswork collaboratively to harmonize their standards.

COMMERCIALIZATION OF HUMAN TISSUES

A number of potential benefits stem from the commercialization ofhuman tissues. For industry, the likelihood of profit based on medicalproducts derived from human tissues is an effective incentive to investin related academic research. With the judicious use of patents andother forms of intellectual property rights, industry has added reasonto support cutting-edge and sometimes financially risky academicresearch involving human tissues. From the perspective of academiccenters, the infusion of capital by industry can help to fund innovative

KEITH BAUER ET AL.114

TABLE

I

Relevantstandardsfrom

ageneralsurvey

oftissuebankingpolicies

Commercialization

Confidentiality

Inform

edConsent

Quality

Assurance

American

Associationof

TissueBanksa

•Noexplicitstatementon

thesellingofbodyparts.

Noexplicitstatement

aboutprofitsto

familiesis

made.

•If

required

bylaw

or

regulation,anexplana-

tionthatnon-profitand/

orfor-profitorganiza-

tionsmaybeinvolved

infacilitatingdonation.

•Donor’smedical

recordsmaybeaccessed

byresearchersandmay

bereleasedto

other

ap-

propriate

parties.

•Identificationofspecific

tissues

beingrequested

fordonationandan

explanationofhow

they

willbeused.

•If

required

bylaw,an

explanationthattissues

maybeusedin

amanner

differentthan

intended.

•Anexplanationof

recoveryprocess.

•Asnotto

undermine

publicconfidence

indo-

nation,tissues

should

be

distributedin

awaythat

‘‘maxim

izeusefulnessto

thepatientcommunity.’’

•Data

hoardingislikelyto

underminethisgoal.

Anexplanationofhow

donation

process

willaffect

body’sappearance

and

burialarrangem

ents.

AmericanMedical

Association

(CouncilonEthical

andJudicialAffairs)b

•Profits

from

commercial

use

ofhumantissuemay

besharedwithpatient.

•N/A

•Inform

edconsentmust

be

obtained

from

patients

for

use

oftissuein

clinical

research.

•N/A

•Potentialcommercialuse

oftissuemust

be

disclosedto

patient

before

profitisrealized.

ETHICAL ISSUES IN TISSUE BANKING 115

TABLE

I(C

ontinued)

Commercialization

Confidentiality

Inform

edConsent

Quality

Assurance

British

Associationof

TissueBanksc

•Statesthat‘‘thereshall

benocommercialdeal-

ingin

humantissue.’’

•Relatives

shallspecifi-

callyagreeto

letthe

tissuebankseek

infor-

mationaboutthedonor

from

professionalssuch

astheGPorpatholo-

gist.

•Recordswillremain

confidential.

•Recordswillbemain-

tained

foraminim

um

of11years

after

the

expirydate

ofthetissue.

•Legallyrequired

inthe

UK

toobtain

consentfor

tissuedonationfrom

per-

sonlegallyin

possessionof

thebody(cadaver).

•It

must

beestablished

that

thedeceaseddid

notobject

todonation.

•It

must

beestablished

that

survivingspouse,partner,

orlivingrelativedoes

not

object

todonation.

•It

must

beestablished

that

noreligiousobstacles

are

•‘‘Allreasonab

leeff

orts

shallbemad

eto

ensure

that

tissues

aresentto

qualified

individuals/or-

ganizationswhohave

acceptedresponsibility

fortheirproper

han

dling

anduse.’’

Nothingstated

about

datahoarding.

•Tissuebankswillin-

form

users

(clinicaland

research)thatalltissue

must

belogged

and

recipienttraceability

must

beinsured.

present.

•Deceased’sreligiousvalues

should

betaken

into

con-

sideration.

•A

written

record

ofinqui-

ries

andtheiroutcomes

•Each

unitoftissuewill

haveauniqueidentifi-

ablecodeandbetrace-

ableto

thedonorwhile

protectingthedonor’s

anonymity.

should

bekept.

•Relatives

should

bein

form

edoftestingto

be

doneonthedonorandof

anypositiveresultsthat

mayhaverelevance

totheirhealth.


•If

tissues

are

notusedfor

transplantation,explicit

consentfrom

donors

or

relatives

must

beobtained

touse

materialsforre-

search.

*•Relatives

shallspecifically

agreeto

letthetissuebank

seek

inform

ationabout

thedonorfrom

profes-

sionalssuch

astheGPor

pathologist.

Belgium

d•The

Crown

Order

of

June13,1986law

for-

bidsthesale

ofbody/

body

parts

and

profit

from

donation.

•The

Crown

Order

of

1986

states

that

confiden-

tialityofdonation

must

bemaintained

–an

onym

-ityap

plies

toboth

donor

and

recipient.

However,

theCrownOrderofApril

15,1988

man

dates

the

keeping

ofdetailed

re-

cordstrackingtheorigin,

processing,

andhan

dling

ofhuman

tissueas

away

toensure

traceabilityof

tissues.

•1986lawsupportsassumed

orpresumed

consent,stat-

ing

thatanyonewho

has

lived

inBelgium

formore

than

6monthsabove

the

ageofeighteen

isapoten-

tialdonor,

unless

express

proofofthatindividual’s

oppositionisavailable.

•Living

donors

may

with-

draw

theirconsentatany-

•1988lawad

dresses

issues

oftechnicalan

dmedical

quality,accreditationof

nonprofittissuebanks.

•No

mention

of

data

hoarding.

time.Close

relativesmay

offer

guidan

ceondonation

byafamilymem

ber

ifthat

mem

ber

isunab

leto

com-

municatehis/her

wishes.


TABLE

I(C

ontinued)

Commercialization

Confidentiality

Inform

edConsent

Quality

Assurance

•Belgium

law

permitstissue

retrievalfrom

anydeceased

Belgianwhoresided

inthe

countryunless

thereis

ex-

pressed

oppositionagainst

it(e.g.,bythefamily).

EuropeanCommis-

sione

•EU

adheres

tothe

principlethatdonations

ofhumantissues

must

befree…andthisrules

outanypaymentto

the

donor(prevents

exploi-

tationofunderprivi-

leged).

•Rejects

claim

thatdo-

nors/familiesshould

be

paid

ifprofitismade

from

donatedtissues.

•Explicitstatementre-

spectingconfidentiality.

•Codingsystem

thatbal-

ancestraceabilitywith

confidentiality.

•Tissues

maynotbere-

moved

ifpersonrefused

consentduringhis/her

lifetime.

•If

therehasbeennoex-

pressionofwillandthe

applicable

system

isthat

•‘‘In

principle,tissue

bankactivitiesshould

bereserved

topublic

healthinstitutionsor

non-profit-makingor-

ganisations.In

such

cases,thismeansthat

thedeliveryprice

of

tissues

only

coversthe

bank’sexpensesrelating

tothetissues

inques-

tion.However,given

thecurrentstate

ofde-

velopmentofthesector,

itisdiffi

cultto

exclude

tissuebankingactivities

bycommercialorgani-

sations,such

asprivate

laboratories.’’


•A

rightnotto

besub-

jected

tounfairtreatm

ent

whichcould

resultfrom

therevelationofcollected

data

tothirdparties(e.g.

employersandinsurance

companies).

of‘‘presumed’’consent,

doctors

must

ensure

asfar

aspossiblethatrelatives

or

nextofkin

havetheop-

portunityto

express

the

deceasedperson’swishes,

andmust

taketheseinto

account.

•Nomentionofdata

hoarding.

•Donor/familyhavearight

topriorinform

ationonthe

conditionsofremovaland

the

expected

use

of

the

tissue

and

likely

public

healthbenefits.

FDA/H

HS2001

Reportf

•Thetissuebankingin-

dustry

should

work

withgroupsrepresent-

ingdonorfamiliesto

explore

publicdisclo-

sure

oftissuebanks’

finances.

•Noexplicitmentionof

thesale

oftissues

for

profitorofsharing

profits

withfamilies.

•Thetissuebankingindus-

tryshould

work

with

groupsrepresentingdonor

familiesto

explore

public

disclosure

oftissuebanks’

finances.

•Requires

allorganiza-

tionsthatmanufacture

humancells,tissues,and

cellularandtissue-based

productsto

registerand

list

theirproductswith

theFDA.Thismeans

thattissueprocessors

anddistributors

‘‘should

ensure

thatin-

form

ationaccompany-

ingtheirproducts

clearlyindicate

itis

derived

from

donated

humantissue.’’


TABLE

I(C

ontinued)

Commercialization

Confidentiality

Inform

edConsent

Quality

Assurance

•Thesenew

requirem

ents

willcreate

thefirst

complete

inform

ation

database

onthetissue

bankingindustry

inthe

US.

•Manytissuebankshave

never

beeninspectedby

thefederalgovernment.

Atiered

system

ofrules

andregulationswillbe

implementedwiththe

goalsof(1)preventing

thespreadofcommu-

nicable

diseasesand(2)

requiringthepre-m

ar-

ket

approvalofsome

tissue-relatedproducts.

No

mention

of

data

hoarding.

France

g•1994law

(94-654)em

-phasizesthatthedona-

tionprocess

(donor-

tissuebankrelation-

ship)should

benon-

commercial.However,

commercialism

isnotcompletely

ruled

out.

•Donors

ofeverytissue

must

beidentified

(for

trackingandpublic

healthprotections).

•1994law

supports

assumed

orpresumed

consentfordeceased

donors,withanoptingout

optionbyregisteringwith

nationalcomputerizedda-

tabase.

•1994law

addresses

is-

sues

oftechnicaland

medicalquality,accred-

itationofnonprofittis-

suebanks.


•‘‘Publichealth

authori-

ties

ornonprofitorga-

nizationsserveastissue

banks,unless

theactiv-

ityatissueishighly

technical(orinvolves

private

sectorresearch

anddevelopment),

therebywarrantingspe-

cialpermissionforin-

terventionbya

commercialcompany.’’

•Ifdeceaseddid

notopt

out/register,more

recent

legislationstatesthat‘‘the

willingnessofthedeceased

todonate

should

besought

throughthefamily.’’

Livingdonors

mustgive

theirexplicitconsent.

•Nomentionofdata

hoarding.

Office

ofInspector

General/HSS2001

Reporth

•Thereport

recognizes

conflictbetweendonor

families’expectations

thatdonatedtissues

will

beusedformedically

indicatedpurposesthat

enhance

thelives

of

othersandthereality

of

tissuebankingwhichis

increasingly

becoming

commercializedand

viewshumantissueasa

commodity.Beyondin-

form

ationoftheusesto

whichtissues

willbe

put,noexplicitguide-

lines

onthe‘‘sale

of

bodypart’’are

recom-

mended

byHHS.

•Familiesshould

begiven

alist

anddescriptionof

other

companiesand

entities

withwhichthe

bankhasarelationship

forprocessinganddis-

tributingtissue.

•Tissuebanksshould

give

families(1)copyofsigned

consentform

,(2)written

materialonhow

tofollow

upwithtissuebankif

problem

arises,(3)afull

descriptionofusesto

whichtissues

maybeput,

(4)alistanddescriptionof

other

companiesandenti-

ties

withwhichthebank

hasarelationship

forpro-

cessinganddistributing

tissue.

•Aspart

offostering

accountability,tissue

banksshould

ensure

thatrequesters

ofhu-

mantissues/organsare

‘‘fullyandappropriately

trained’’and‘‘provide

continuingeducation

forrequestors.’’


TABLE

I(C

ontinued)

Commercialization

Confidentiality

Inform

edConsent

Quality

Assurance

•‘‘Thetissuebankingin-

dustry

should

work

with

groupsrepresentingdo-

norfamiliesto

explore

aprocess

forperiodic

publicdisclosuresabout

tissuebanks’financing’’

asawayofresponding

tofamilyandthegen-

eralpublicconcerns

aboutknowingthe

sources

offundingfor

tissuebanksandother

entities

withwhichthe

bankhasfinancial

arrangem

ents.

•Noexplicitstatement

ondata

hoarding.

However,HHSin

an

effort

tofoster

greater

accountabilityrecom-

mendsthattissuebanks

‘‘conduct

anongoing

assessm

entofreques-

tor’sperform

ance

asa

meansofensuringthat

they

are

providingfull

andaccurate

inform

a-

tionto

familiesap-

proached

for

donation.’’Data

hoard-

ingcould

preventthis

from

happening.

UK

MedicalResearch

Councili

•Commercialcompanies

should

beallowed

ex-

clusive

accessto

data

(nottissuesamples)

for

asignificantperiodof

timeto

secure

patent

protectionandcompe-

titiveadvantage.

•When

possible,patient

identifiable

inform

ation

should

beanonymized

andidentifiable

health

inform

ationshould

only

beaccessible

tostaff

whohaveform

alduty

ofconfidence

todonors/

researchparticipants.

•MRC

rejectsblanket

con-

sentapproach

fortheuse

ofbiologicalsamples,but

supportsdonorconsentfor

abroaduse

forsamplesas

awayto

avoid

cumber-

someandcostly

process

of

obtainingconsentrepeat-

edly.

•Commercialcompanies

canhaveaccessto

bio-

logicalsamples,butno

exclusiveaccessto

sam-

plesispermissibleunless

MRC

andindustry

jointlyfundthere-

search.

•Thesaleofhumantissues

isnotconsidered

ethi-

callyacceptableand

should

belegally

prohibited.Thedonated

Donors

haverightto

know

whether

research

findingsaffects

them

or

familymem

bers.


bodypart

ortissuesam-

ple

isa‘‘gift’’andnota

commodityforexchange

inthemarketplace.Sam-

plesare

given

tocompa-

nieswiththeaim

of

improvingthehealthof

citizens.

•Because

biologicalsam-

plesare

gifts

toresearch-

ers,they

oughtnotto

be

sold

andresearchers

oughtnotto

profit.

However,commercial

companies(e.g.,pharm

a-

ceuticals)canprofit.

•MRC

guidelines

apply

tolivingdonors.

Asa‘‘gift,’’donors

can

place

restrictionsontheuse

ofbiologicalsamples/can

specifywhatcanandcannot

bedone.

However,MRC

statesthatmanydonors

would

nothavesufficient

understanding(scientific)

of

whatresearchmightbepos-

sible

forthisto

bemean-

ingful.

Livingdonors

should

not

beoffered

monetary

in-

ducements

todonate.

•Generally,noprofits

will

goto

donors.

Spain

j•‘‘Thehumanbodyandits

partsshall

not,

assuch,

giverise

tofinancialgain.

Activities

and

expenses

related

tohandling

and

managem

entoftissues

as

wellassubstance

orother

•‘‘Theidentity

ofthedo-

nor

isnot

relevantto

research

purposesan

dis

protected

bytherigh

tto

confidence.Theprinciple

ofconfidence

isbased

on

naturalattributesofhu-

man

beings

and

•‘‘In

the

case

of

apost-

mortem

donor,

there

are

fiveoptions:(1)

‘‘Required

consentoropt-

ing

in’’

during

life

ofthe

potentialdonorwhich

must

beexpressed

byan

N/A


TABLE

I(C

ontinued)

Commercialization

Confidentiality

Inform

edConsent

Quality

Assurance

materialusedin

theac-

quisitionandpreserva-

tionoftissues

are

able

tobeconsidered

asabudget

tobepaid

when

atissueis

required

forresearch.At

thesametime,

theactiv-

itiesofprofessional[s].

(technicians,MD

and

other

investigators)have

therightto

bereim

bursed

accordingto

theservices

carriedout,andthepro-

fessionalqualifications.’’

onthenature

ofhuman

relationships.Eachindi

vidualhas

therigh

tto

privacy

andconfiden-

tiality.’’

•‘‘Researchusinghuman

tissues

canbringnew

in-

form

ationab

outthedo-

nor.Thismay

occureven

wherethematerialisused

inwaysnotap

parently

relatedto

that

person’s

condition.T

hepossibility

ofnew

findings

ofsign

ifi-

cance

tothefamilymem

-bersfrom

whom

material

was

taken

should

playan

importan

tpartin

the

ethicalconduct.In

this

context

theacquired

confidence

withthedo-

normay

becomeirrele-

vantandthepossibilityto

inform

aboutnew

act

ofdonation.(2)‘‘Con-

tractingoutoroptingout,’’

meaningthedonornever

expressed

objectionto

organ

donationduringlife.Ac-

cordingto

thisconceptallof

usare

possible

donors.In

Spain,thelegislationaccepts

the2ndconcept.However,

inthebrain

bankin

Barce-

lona,acombinationofthe

required

consentwiththe

consentofrelatives

orin

casesofdeaddonors,the

consentofrelatives

isalways

required.

findingscould

betaken

into

account.TheCon-

ventiononHuman

Rights

andBiomedicine

hasestablished

that

everyonehastherightto


privacy

regarding

their

health

condition.In

ex-

ceptional

cases

restric-

tionsmay

be

placed

by

law

ontheexercise

ofthe

mentioned

right.’’

Report

onUK

Tissue

Bankingin

theNHSk

•Donors

‘‘needto

be

inform

edparticularlyif

theresearchwillbe

commercial,andgiven

theopportunityto

con-

sentordeclineto

donate

when

inpossessionof

thefullfacts.’’Thefi-

nancesofUK

tissue

banksshould

besubject

tosomeform

ofexter-

nalaudit.

•Data

should

beanon-

ymized,butshould

re-

main

linked

because

unexpectedresearch

findingsmight

benefitfrom

further

detailsaboutthe

donor.

•Theuse

ofadoctorasa

‘‘medicalinterm

ediary’’

isrecommended

topro-

tect

thedonor’srightto

privacy

andconfidenti-

ality.

•Donors

‘‘needto

bein-

form

edparticularlyifthe

researchwillbecommer-

cial,andgiven

theoppor-

tunityto

consentordecline

todonate

when

inposses-

sionofthefullfacts.’’

Speciallydesigned

form

sthatem

ployachecklist

should

beuse

with

donors.

•Written

consentshould

be

obtained.

•Inform

ationpacket

should

beprovided

todonors.

Inform

ationaboutthesto-

rageanddisposaloftissue/

organsshould

begiven

todonors.

•‘‘Controlsoftheusers

ofmaterialsupplied

by

tissuebanksare

more

limited.However,safe-

guardscanbeintro-

ducedbylegalcontract

andinsistingthatdetails

ofproposedusesoftis-

sues

are

madeavailable

priorto

supply.’’

•In

casesofcadaveric

tissue

retrievals,thesesamein-

form

edconsentguidelines

apply

torelatives

ofde-

ceased.


TABLE

I(C

ontinued)

Commercialization

Confidentiality

Inform

edConsent

Quality

Assurance

NationalBioethicsAd-

visory

Commissionl

N/A

•In

light

of

(Common

Rule45CFR46),NBAC

provides

differentrecom-

mendationsonthehand-

ling

oftissue

samples/

organ

sdepending

on

whether

they

comefrom

living

donors

and

are

being

used

inresearch,

‘‘…federal

legislation

concerning

medical

re-

cord

privacy

should

in-

clude

provisions

for

legitim

ate

accessby

re-

searcherswhohavemet

allapplicablereviewan

dconsentrequirem

ents.’’

•Recommendsmany

levels

ofconsentabout:(1)refu-

sal,(2)whether

biological

materials

willbe

identifi-

able

orcoded,(3)thetype

ofstudiesin

whichmateri-

als

willbe

used,and

(4)

risks.

•In

light

of

(Common

Rule45CFR46),NBAC

recommendsthatbefore

coded

and/oridentified

samplesare

released,a

repository

shouldrequire

investigators

requesting

samples

toeither:

(a)

provide

documentation

forrequester’sIR

Bthat

research

willfollow

ex-

istingfederal

guidelines;

or(b)explain

whytheir

research

isexem

ptfrom

those

regulations.

aAmericanAssociationofTissueBanks,McL

ean,Virginia,USA,URL:http://w

ww.aatb.org/guidelines.htm

(accessed2002Feb

22).

bAmericanMedicalAssociation,Chicago,IL

,USA,URL:http://w

ww.ama-assn.org/ama/pub/article/4301–4409.htm

l(accessed2002Feb

22).

cBritish

AssociationofTissueBanks,London,UK,URL:http://w

ww.batb.org.uk/eneral1.htm

(accessed2002Feb

22).

dB.Indech,‘‘TheInternationalHarm

onizationofHumanTissueRegulation:Regulatory

ControlOver

HumanTissueUse

andTissue

Bankingin

SelectCountriesandtheCurrentState

ofInternationalHarm

onizationEfforts,’’FoodandDrugLawJournal2000[55]:343.

eTheEuropeanGrouponEthicsin

Science

andNew

Technologies.

EthicalAspects

ofHumanTissueBanking,199821July,No.11,

URL:http://europa.eu.int/comm/european_group_ethics/docs/avis11_en.pdf(accessed2002Feb

22).

f DepartmentofHealthandHumanServices.Humancells,tissues,andcellularandtissue-basedproducts;establishmentregistrationand

listing.Washington,DC,FederalRegister200119Jan(66)13,URL:http://w

ww.fda.gov/cber/rules/frtisreg011901.pdf(accessed2002

Feb

22).


gLaw

No.94-654.France

1994

July

29,URL:http://translate.google.com/translate?hl=

en&sl=

fr&u=

http://w

ww.m

ultim

ania.corn/

aedb/legislat/france/lois/l-94654.htm

&prev=

/search%

3Fq%

3D94-654%

2BFrance%

26hl%

3Den

(accessed2002Feb

22).

hDepartmentofHealthandHumanServices,Office

oftheInspectorGeneral.Inform

edconsentin

tissuedonation:expectationsand

realities.Washington,DC.2001Jan.OEI-01-00-00440.URL:http://w

ww.fda.gov/cber/tissue/infrmcnsnt.pdf(accessed2002Feb

22).

i MedicalResearch

Council.

UK

Human

tissue

and

biologicalsamplesforuse

inresearch.1999.URL:http://w

ww.m

rc.ac.uk/

pdf_tissue_guide_fin.pdf(accessed2002Feb

22).

j F.F.Sanchez,Emerging

ethicalissues

inbrain

banking.European

Commission,URL:http://w

ww.iprs.it/brainelsa/BACKUP_cd/

banks1-1ter.htm

(accessed2002Feb

22).

kC.Womack

andN.Gray,‘‘HumanResearchTissueBanksin

theUK

NationalHealthService:Laws,Ethics,ControlsandConstraints.’’

British

JournalofBiomedicalScience.2000March(57)1:250–253.

l NationalBioethicsAdvisory

Commission.Washington,DC,Draftreport

ontheuse

ofhumanbiologicalmaterials,1999May7,URL:

http://bioethics.georgetown.edu/nbac/briefings/may99/hbm_ch4.pdf(accessed2002Feb

22).


research and support the training of researchers. Perhaps the mostimportant benefit associated with the commercialization of humantissue comes from the successful interchange between the two spheres,toward a more efficient transmission of knowledge from academic-based tissue banks to industry, facilitating the development anddelivery of medical products to the public.7

There is, however, a potential downside to the commercializationof human tissues. Specifically, the growth of for-profit tissue banksand augmented academic-industry partnerships increase the likeli-hood of conflicts of interests. For example, financial incentives toacademic researchers (e.g., stock options and royalties) couldundermine scientific standards of integrity by promoting secrecy, datahoarding, and even the manipulation of research outcomes. If thisoccurs, the commercialization of human tissues could have theunintended consequence of compromising human tissue research andsubordinating the health of the public to profit maximization.

Beyond concerns regarding conflicts of interests, the commercial-ization of human tissues also raises a host of broader social, cultural,religious, and psychological issues on the meanings we assign to thehuman body and, in particular, on how we treat it during life andafter death.8 Many people conceptualize the transfer of human or-gans and tissues during life or after death as a gift motivated byaltruistic feelings, not economic incentives. They believe that thebuying and selling of human biological samples debases the value ofhuman life, is antithetical to the gift paradigm of tissue transfer, canlead to further oppression of the disenfranchised and the poor, and isan affront to the dignity of donors and their families. Others, how-ever, point out that the commodification of human tissues is not new9

(e.g., blood and sperm), and that ‘‘it is virtually impossible to imaginehow human biological materials would be distributed if commerce insuch materials were prohibited.’’10 In fact, although U.S. federal lawprohibits the buying and selling of human organs, it does allow feesfor the recovering, processing and transporting of human tissue.11

The exportation of blood from the U.S. alone is a multi-billion dollarindustry;12 other human tissues such as hair and corneas play animportant role in commerce. Although the commodification of hu-man tissue is not completely novel, the potential for much greatercommercialization of human tissue does exist.

As illustrated in Table 1, the British Association of Tissue Bank-ing (BATB),13 Belgium,14 and Spain15 have adopted policies and lawsthat simply ban all commercial dealings in human tissues. The BATB,


for example, states ‘‘there shall be no commercial dealing in humantissue,’’ the Spanish government holds that ‘‘the human body and itsparts shall not, as such, give rise to financial gain’’ and, as specified inThe Crown Order of June 13, 1986, the government of Belgiumsimply forbids the sale of body/body parts and profit from donation.The problem with this kind of approach is that it fails to specify whatcounts as a commercial activity and ignores or refuses to value thepotential benefits of such activity. The American Association ofTissue Banks (AATB)16 provides even less guidance, as it has noexplicit statement, general or specific, about the commercial aspectsof tissue banking.

Unlike the BATB and the AATB, two reports from the Health andHuman Services/Food and Drug Administration/Office of InspectorGeneral (HHS/FDA/OIG) provide guidelines that address some ofthe commercial aspects of tissue banking.17 As illustrated in Table 1,these agencies hold the view that ‘‘the tissue banking industry shouldwork with groups representing donor families to explore public dis-closure of tissue banks’ finances.’’ Although these reports do not goas far as endorsing commercialization, they do recommend that do-nors/families be informed in a general way of the commercial uses ofdonated tissues and that tissue banks disclose their financing, as wellas the industries with which they have financial arrangements.

Even if we grant that commercial academic-industry relationshipsare beneficial for spurring innovative research and providinghealthcare services and products to the public, there remains theunresolved issue of whether donors and families should be financiallycompensated for donated tissues and for any profits that are gener-ated by the research. The two HHS/FDA/OIG reports do not addressthis issue, but the policies developed by the European Commission(EC), the Medical Research Council (MRC),19 and France20 are ex-plicit in their rejection of financial compensation and profit sharingwith donors/families. There are two reasons why profit sharing withdonors/families is rejected. One reason, according to the MRC, isthat a donated body part or tissue sample is a ‘‘gift’’ and not acommodity for exchange in the marketplace. A second reason held bythe EC, the MRC, and France is that the introduction of financialincentives could lead to the exploitation of donors/families. Overall,however, the EC, MRC, and France do allow for limited partnershipswith industry. The MRC, for example, recommends that commercialcompanies receiving human tissues be allowed exclusive access todata for a period of time to secure patent protection and competitive


advantage, whereas France recognizes that industry might at timeshave more resources to carry out highly technical human tissue re-search that will eventually benefit public health.

Still, all the policies but that of the AATB reflect an understandingof the most likely abuses associated with the commercialization ofhuman tissue. The spectrum of positions on the commercialization ofhuman tissues is represented in Table 2.

CONFIDENTIALITY

Confidentiality, which refers to the promise not to disclose infor-mation that the donor does not want disclosed, is treated by all theorganizations and countries that were surveyed as an important valueto be protected. Different levels exist among methods to curtailbreaches of confidentiality. Commentators have outlined a usefultaxonomy of:

• Identified: The tissue source is known and the individual’s identityis tied to the sample.

• Identifiable: The tissue source is tied to the specimen through theuse of a link (e.g., a code number), but the identity of the source isnot directly known without tracing the link.

• Anonymized: The tissue source’s identity is irrevocably unlinkedfrom the specimen, so that the individual’s identity cannot bediscerned (i.e., the tissue is not identifiable).

• Anonymous: The tissue source’s identity is never known, since thespecimen is collected with no identifiers at all (i.e., the sample isunidentified).21

Anonymity is achieved when tissue made available for research willnot have any personally identifiable links. This is one of the mosteffective ways to maintain confidentiality. However absolute confi-dentiality is nearly impossible to achieve in practice; nor is it alwayssought. Indeed, once tissue samples are anonymized, their potentialuses in research are diminished – findings associated with tissuesamples cannot be linked back to information regarding the samples’source of origin. On the other hand, linked specimens trigger the needfor IRB review to make certain human subjects are adequately pro-tected.22

The issue of whether tissues are stored as anonymized or identifiedspecimens requires attention. If the tissue is identified, the question


TABLE

II

Policy

optionsfortissuebankingfacilities

thatmakesample

available

tothirdparties

Policy

options

Most

‘‘laissezfaire’’

Most

stringent

Commercialization

•‘‘Sales’’ofbody

partsto

thirdparties

•Possible

data

hoarding

bythirdparties

•Sharingprofits

withthe

donor/donor’sfamily

•Negotiate

rate

with

each

‘buyer’

•Takenoaction

•Set

variable

pricesbased

on‘‘custo-

mer’’type

•Set

fixed

prices,ap-

plicable

to

all

•Takevoluntary

donationsfrom

allresearchers

•Takevo-

luntary

do-

nations

from

com-

mercialre-

searchers

only

•Takeno

money

from

anyresearch-

ers

•(A

)Requirethirdpartiesto

disclose

data

tothefacility,

withredisclosure

toother

investigationsatfacility’s

option

•(B)Require

thirdparties

topublish

theirresults

•(A

)+

(B)

•Negotiate

compensationwith

each

donor/donor’s

family

•Flatdonationamountto

do-

nor/donor’sfamily

•State

inconsentform

sthat

nocompensationwillgoto

thedonor/donor’sfamily

Confidentiality

•Confidentiality/anonymi-

zationoftissue/records

•Third

parties

gran-

tedunlimited

access

todata,includingall

medicalrecords

•Tissuefacility

requires

sepa-

rate

consentfrom

donor/fa-

miliy

forrelease

ofmedical

record

•Facility

screens

additionaldata

requestby

researchers

•Facility

provides

limited

dem

ographic

inform

ationon

‘‘fully’’de-identified

and

un-

linked

samples


TABLE

II(C

ontinued)

Policy

options

Most

‘‘laissezfaire’’

Most

stringent

Inform

edConsent

•Inform

edConsentof

Donor/Family

Opt-out/opt-in

provi-

sionsforcertain

usesof

material

•Minim

aland

blanket

consent

•Donors

cannotre-

strict

use

ofdona-

tions

•Donors

may

state

non-

bindingpre-

ference

foruse

oftissues

•Manylevals

ofspecifi-

city

•Comprehensive,

blanket

consent

(B)Donars

(A)Donors

canrestrict

use

oftissue

toresearch

onspecific

diseases

canrestrict

use

oftissue

tospecify

research

organization

•(A

)+

(B)

Quality

Assurance

•Ensuringquality

ofre-

searchthatissupported

•Handlingfinancial

conflicts

ofinterest

•Facility

gives

un-

limited

accessof

materialto

allwho

requestit

•Nodisclosure

or

avoidence

provi-

sions

•Facility

uses

aninternal

committeeto

review

con-

troversial

proposals

•Facility

usesanin-

ternalcom-

mitteeto

review

all

proposals

•Facility

usesan

externalcom-

mitteeto

review

controversial

proposal

•Facility

usesanin-

dependent,

external

committee

toreviewall

proposals

•Disclosure

financial

arrangments

topublic/do-

nors/family

•Lim

itfinancialinteractions

(Lim

ited

reim

bursem

ent,no

stock

options,etc…

)

•Nocompensation

orgifts

from

researchersor

organizations


arises of whether researchers may access the donor’s medical records.If this will be permitted, safeguards must be put into place to protectthe donor’s (or donor’s family’s) confidentiality, even prior to theinformed consent process.

The BATB and the EC require coding systems that preserve bothtraceability and confidentiality. Within these policies, tissues are ei-ther identified or identifiable so that limited follow-up by authorizedparties remains possible (if, for instance, a donor wanted to knowabout the possibility of commercial profitability). Unlike the BATBand EC, Spain has specific language that states, ‘‘the identity of thedonor is not relevant to research purposes and is protected by theright to confidence.’’ Other organizations, including the UK’s MRCand the Report on UK Tissue Banking on NHS, use language such as‘‘should’’ rather than ‘‘must’’ in requiring anonymization.23 Some USorganizations have recently developed new policies that addressadequate safeguards for maintaining confidentiality at the level ofinformed consent and beyond. For instance, the AMA’s Code ofMedical Ethics recommends that the level of privacy be disclosed toresearch subjects (i.e., whether the biological material will be coded orcompletely de-identified).24 Finally, the FDA has recently promul-gated rules to regulate the tissue banking industry. All organizationsthat manufacture human cells, tissues, and cellular or tissue-basedproducts will have to register and list their products with the FDA.Moreover, the new Health Insurance Portability and AccountabilityAct of 1996 (HIPAA) regulations in the US prohibit disclosures of‘‘any protected health information related’’ to an individual’s tissuesamples.25 These new requirements will create the first comprehensivedatabase of tissues banked in the US. The resulting database is likelyto appeal to private and public entities for its research potential aswell as commercial opportunities, as well as to raise future privacyconcerns.

INFORMED CONSENT

Informed consent serves as a safeguard for individuals’ rights andwelfare, by providing them the opportunity to understand an inter-vention, its scope, and its implications, before they decide whether toagree to it. In the context of this discussion, the intervention is thecollection of tissue samples by a tissue storage facility for the purposeof research.


What should the informed consent process for the collection oftissue samples include? This question pertains to tissue samples thathave yet to be collected. It needs to be distinguished from a relatedbut separate matter: What should be done with collected tissuesamples that were obtained with informed consent that would notmeet current standards? The latter question is not directly addressedin this paper, which concerns itself with the collection of tissue, exceptto say that the more rigorous alternative of going back to donors ordonors’ families to obtain consent for unanticipated uses is the goldstandard: it provides assurance that the donor’s wishes will be re-spected. Unless donors (or their families) understand the specificnature of a research protocol in which they are enrolling, they neithercan assess adequately whether participation in the overall investiga-tion is consistent with their values, nor freely and deliberately refuseparticipation in certain aspects of a study.

For the reasons described above, minimal blanket consent, as re-flected at one end of the spectrum in Table 2, is believed to be aninappropriate option for informed consent.26 A comprehensiveblanket consent, which tries to anticipate in detail every possible use,present and future, of a tissue sample, may be overly burdensome andstill may prove insufficient. The intermediary option offers a consentprocess that is tailored to the needs of the individual donor (or donorfamily) and to specific circumstances. The merit of the third optionis that it is more flexible than the other two. However, all threepolicy alternatives for informed consent address the items discussedbelow.

Collecting Tissue Samples: The Intervention

Standards of informed consent require that the donor (or donor’sfamily) have an adequate understanding of the procedure to retrievetissue, including its risks and benefits. How the tissue will be re-moved, how much of it will be removed, and how the procedure willmodify the appearance of the donor’s body are among the questionsthat should be addressed, as well as any physical risks associated withthe intervention in the case of a living donor.

Collected Tissue Samples: Anticipated Uses

Tissue storage facilities receive donations and make samples availableto investigators for research purposes. The donor (or donor’s family)may want to know whether the facility has ties with commercial, as


well as non-commercial, companies. Does it stand to benefit finan-cially? What criteria does the facility use to determine to whom toprovide tissue samples? The party making the donation may be ableto limit or suggest to what sort of company the samples should beprovided. Along similar lines, the donor (or donor’s family) mighthave the opportunity to specify or recommend toward what type ofresearch the tissue may be used. The risk is that people with insuffi-cient scientific grounding will participate in complex research deci-sions and that they may request limits that are difficult, unfeasible, orimpossible to implement.

Findings from Research on Tissue Samples

It seems best to discuss at the time consent is sought what will laterbecome of information derived from tissue samples. Two majorquestions arise with regard to findings. Should they be communicatedto the donor (or donor’s family)? It may be feasible for the facility tocontact the donor (or donor’s family) with findings that pertain tothem, where the samples were identified. For this reason, it isimportant for potential donors to contemplate whether this isinformation they would welcome – and in what detail. Knowledgeregarding the risks and benefits associated with learning this sort ofinformation – and what it means that it is familial in nature – canhelp inform this decision. Where tissue samples are anonymized,general findings are the only kind of information the donor (or thedonor’s family) can consent to receive.

The other question that arises from the findings is whether thedonor (or donor’s family) can share in any profits from products,tests, or discoveries that result from the research. While it seemseasiest to preclude this sort of sharing, some organizations allow it.Details of how the donor (or the donor’s family) will benefit areworked out during the consent process. In these latter cases, it ishelpful to determine conditions as part of the informed consentprocess.

While the organizational policies that were reviewed all include adiscussion of consent, they reflect a broad range of standards. Severalof the European policies rely on notions of presumed consent fororgan and tissue retrieval from deceased individuals (Belgium,European Commission, France, and Spain), while British andAmerican policies stress informed consent with different levels ofspecificity.


QUALITY OF RESEARCH

Tissue donors might well assume that their tissues will be used only tofurther research that is of the highest possible quality. But tissues arefrequently in greater demand than banks can supply, so allocationdecisions must be made. In this process, the presumption that onlythe highest quality research projects will receive tissues may be sub-verted by both organizational and personal conflicts of interest.Financial conflicts of interest pose immediate concerns. For example,if providing tissues to commercial researchers promises greaterfinancial rewards for the tissue bank, or its staff, there may be atemptation to provide tissue to these researchers even at the expenseof other, higher quality, research proposals from non-commercialsites. But not all potentially conflicting interests are financial. Re-

TABLE III

Definitions of key terms

Key terms Definitions

Human tissue Includes everything from organs and parts of organs, cells and

tissues to subcellular structures and cell products, blood,

gametes, embryos and fetal tissue, and waste. Also referred to

as ‘‘human biological material.’’

Renewable tissue Renewable tissue refers to tissue that the body produces and

replenishes on a regular basis. Such tissue includes hair, nails,

gametes and skin.

Non-renewable

tissue

Non-renewable tissue refers to tissue and organs that the body

does not replenish. Such tissues and organs include internal

organs such as liver and kidneys as well as corneas.

Tissue banking Tissue banking is the storage of tissue. Tissue is stored for

diagnostic procedures, surgical treatment, as well as educa-

tional and research purposes.

Tissue storage Tissue is stored in military facilities, forensic DNA banks,

government laboratories, diagnostic pathology and cytology

laboratories, university- and hospital-based research labora-

tories, commercial enterprises, and nonprofit organizations.

aC. Naser and S. Alpert, ‘‘Genetic Information, Ethics, Ethical Issues in TissueBanking and Human Subject Research in Stored Tissues,’’ in Encyclopedia of

Ethical; Legal; and Policy Issues in Biotechnology, eds. T.H. Murray and M.J.Mehlman (New York: Jon Wiley & Sons, 2000), pp. 363–369.


search that is of particular interest to the bankers may receive specialconsideration, which may or may not be appropriate. A bankestablished to promote research in Alzheimer’s disease will rightfullygive priority to projects that directly address this condition, butwould it be appropriate for the director of the bank to refuse toprovide tissues to researchers in areas that compete with his or herown research?

To avoid the perception, or reality, of poorer quality researchtaking precedence over higher quality research for financial or otherinappropriate reasons, tissue banks can attend to issues such as whomakes allocation decisions, using what criteria, and under whatchecks and balances, with greater transparency. Unfortunately, theseissues were directly addressed in only five of the documents weexamined (AATB, BATB, HHS/OIG, Womack and Gray). Eventhese policies tended towards broad statements about preventingdiscrimination, maximizing research benefits, avoiding financialconflicts of interest, and ensuring that recipient scientists are trainedin the proper handling and use of donated tissues.

DISCUSSION

In light of our examination of representative tissue banking policies,we believe that tissue banks systematically should consider the fol-lowing requirements:

First, each tissue bank should have a mission statement, againstwhich it can assess the merits of proposed uses of donated tissue.Developing such a document will serve to provide a definition ofwhat constitutes high quality research in the eyes of the particularbank.

Second, financial conflicts of interest can be addressed, in part, byensuring that those making tissue allocation decisions do not havepersonal financial stakes in potential recipient organizations, or bysharply circumscribing such relationships. Table 1 lists a few of theways in which organizations have proposed limiting financial inter-actions between tissue banks, their officers and staff, and commercialor non-commercial enterprises. Except in the smallest of organiza-tions or where no shortage of tissues exists, no single person shouldhave control over allocation decisions. At minimum, there should bewritten criteria for evaluating proposed research projects; at best,there will be a clearly defined process for reviewing and approving the


use of donated tissues, which will fall along the continuum outlined inTable 2.

Third, tissue banks should be explicit about their standards of‘‘confidentiality:’’ Are tissues identified, identifiable, anonymized, oranonymous? They should develop adequate methods to limit brea-ches of confidentiality, which are made known. Tissue bankingguidelines and policies need be specific about the conditions underwhich donated tissues will be deemed confidential. By doing so, tissuebanking guidelines will be more effective in minimizing potentialharms to donors, donor families, as well as to future tissue researchand product development.

Fourth, tissue banking guidelines and policies should specify whatinformation to address as part of the informed consent process. Todo this, tissue banks will already need to be clear about their mission,financial arrangements, and level of confidentiality protections theyintend to use. It is only after receiving the required information thatthe donor (or donor’s family) can arrive at an informed decisionabout whether to provide tissue samples to the facility. Toward thisgoal, the information to be addressed should be presented in clearand understandable language.

These four main requirements are meant to offer general guidanceregarding ethical considerations that deserve to be examined. Theyare neither exhaustive, nor absolute. Rather, they relate to the fourfactors (commercialization, confidentiality, informed consent, andquality of research) that emerged from the authors’ review. Institu-tional Review Boards, or corresponding bodies, the purview of whichis to ensure the protection of research participants, must be involvedto aid tissue banks by providing appropriate oversight and moni-toring of their activities that relate to research, as well as assistancewith specific ethical issues as they arise.

CONCLUSION

Some organizational policies do not address commercialization, whileothers fail to consider confidentiality and quality of research. How-ever, even in those instances where one of the four factors is recog-nized by all policies (commercialization, confidentiality, informedconsent, and quality of research), there is often a lack of uniformity inits meaning, scope, and ethical significance. Until uniform ethicalguidelines regulating the storage, distribution, and use of human


tissues for research are established, the international transfer of hu-man tissues and multinational research involving industry will notonly remain cumbersome but, in many instances, ethically problem-atic. We propose that governments, non-governmental organizations,and other institutions further collaborate and harmonize policiesregarding human tissue, keeping in mind the four factors we outlinehere.

ACKNOWLEDGEMENTS

We thank Matthew Wynia, MD, MPH for suggesting the idea behindthis article and for providing some conceptual foundations during itsearly development. We also thank Elisa Gordon, PhD, Erin Egan,MD, JD, and Robert Mittendorf, MD, DrPh, for their commentsand suggestions.

NOTES

1 Deborah Josefson, ‘‘Human Tissue for Sale: What Are the Costs?’’ WesternJournal of Medicine 5 (2000): 302–303.2 Ted T. Ashburn, Sharon K. Wilson, Barry I. Eisenstein, ‘‘Human Tissue Researchin the Genomic Era of Medicine: Balancing Individual and Societal Interests,’’ Ar-chives of Internal Medicine 160 (2000): 3377–3384. See also, generally, Robert F.Weir, ed., Stored Tissue Samples: Ethical, Legal, and Public Policy Implications (Iowa

City: University of Iowa Press, 1998).3 See Table 3 for a list of definitions regarding human tissue. For the purposes ofthis paper, we generally exclude organs from the definition of tissue. Moreover,

‘‘donor’’ in this paper means both living and deceased individuals.4 Joseph B. Martin, Dennis L. Kasper, ‘‘In Whose Best Interest? Breaching theAcademic-Industrial Wall,’’ New England Journal of Medicine 343 (2000): 1646–

1649.5 Deborah Josefson, ‘‘US Hospitals to Ask Patients for Right to Sell their Tissue,’’British Medical Journal 321 (2000): 653.6 The authors identified these four factors in the early stages of their research, whenconsidering whether and under what conditions non-profit academic brain tissuerepositories should provide for-profit private companies with brain tissue samples ofdeceased individuals.7 John P. Swan, Academic Scientist and the Pharmaceutical Industry (Baltimore: TheJohn Hopkins University Press, 1988).8 Dorothy Nelkin, Lori Andrews, ‘‘Homo Economicus: Commercialization of Body

Tissue in the Age of Biotechnology,’’ Hastings Center Report 28 (1998): 30–39.9 Linda F. Hogle, Recovering the Nation’s Body: Cultural Memory;Medicine; and thePolitics of Redemption (New Brunswick, NJ: Rutgers University Press, 1999): 24.


10 Julia D. Mahoney, ‘‘The Market for Human Tissue,’’ Virginia Law Review March,

86 (2000): 163–223.11 National Organ Transplant Act, 1984. Pub L. No. 98–507, 3 USC *301.12 Danielle M. Wagner, ‘‘Property Rights in the Human Body: The Commerciali-

zation of Organ Transplantation and Biotechnology,’’ Duquesne Law Review, 33(1995): 931–958.13 British Association of Tissue Banking, ‘‘General Standards for Tissue Banking,’’

(Sept 29, 1999). Available at: http://www.batb.org.uk/general1.htm.14 Barbara Indech, ‘‘The International Harmonization of Human Tissue Regulation:Regulatory Control over Human Tissue Use and Tissue Banking in Select Countries

and the Current State of International Harmonization Efforts,’’ Food and LawJournal, 55 (2000): 343–372.15 F.F. Cruz-Sanchez, ‘‘Emerging Ethical Issues in Brain Banking,’’ EuropeanCommission financed Ethical, Legal, and Social Aspects of Brain Research (1997).

Available at: http://www.iprs.it/brainelsa/BACKUP_cd/banks1-1ter.htm.16 American Association of Tissue Banks, ‘‘Ethical Guidelines for CommercialActivities and Advertising,’’ (Sept. 11, 1996). Available at: http://www.aatb.org/

guidelines.htm.17 Department of Health and Human Services, ‘‘Human Cells, Tissues, and Cellularand Tissue-Based Products; Establishment Registration and Listing,’’ Federal Reg-

ister 66 (Jan. 19, 2001): Rules and Regulations. Available at: http://www.fda.gov/cber/rules/frtisreg011901.pdf.18 European Group on Ethics in Science and New Technologies to the European

Commission, ‘‘Ethical Aspects of Human Tissue Banking,’’ 11 (July 21, 1998).Available at: http://europa.eu.int/comm/european_group_ethics/docs/avis11_en.pdf.19Medical Research Council Working Group to Develop Operational and Ethical

Guidelines, ‘‘Human Tissue and Biological Samples for Use in Research,’’ (April2001). Available at: http://www.mrc.ac.uk/pdf-tissue_guide_fin.pdf.20 See note 15, above.21 Curtis Naser and Sheri Alpert, ‘‘Genetic Information, Ethics, Ethical Issues inTissue Banking and Human Subject Research in Stored Tissues,’’ in: Encyclopedia ofEthical; Legal; and Policy Issues in Biotechnology, eds. T.H. Murray and M.J. Me-

hlman (New York: John Wiley & Sons, 2000), p. 365.22 Naser, Alpert cited in n. 21, above, p. 367.23 Christopher Womack, Neil Gray, ‘‘Human Research Tissue Banks in the UKNational Health Service: Law, Ethics, Controls and Constraints,’’ British Journal of

Biomedical Science 55 (2000): 250–253.24 ‘‘Opinion 2.079: Safeguards in the Use of DNA Databanks in Genomic Re-search,’’ in Council on Ethical and Judicial Affairs, American Medical Association,

Code of Medical Ethics: Current Opinions with Annotations (Chicago, IL: AMAPress, 2002).25 Department of Health and Human Services, Office of the Secretary, ‘‘Standards

for Privacy of Individually Identifiable Health Information,’’ 45 CFR Parts 160through 164. See http://www.cms.hhs.gov/hipaa/hipaa2/regulations/privacy/final-rule/PvcTxt01.asp.


26 Henry T. Greely, ‘‘Breaking the Stalemate: A Regulating Framework for

Unforeseen Research Uses of Human Tissue Samples and Health Information,’’Wake Forest Law Review, 34 (1999): 737–766.

REFERENCES

American Association of Tissue Banks. ‘‘Ethical Guidelines for Commercial Activ-ities and Advertising.’’ (September 11, 1996). Available at: http://www.aatb.org/

guidelines.htm.Ashburn, T.T., S.K. Wilson, and B.I. Eisenstein. ‘‘Human Tissue Research in the

Genomic Era of Medicine: Balancing Individual and Societal Interests.’’ Ar-chives of Internal Medicine 160 (2000): 3377–3384.

British Association of Tissue Banking. ‘‘General Standards for Tissue Banking.’’(September 29, 1999). Available at: http://www.batb.org.uk/general1.htm.

Council on Ethical and Judicial Affairs, American Medical Association. Code of

Medical Ethics: Current Opinions with Annotations. Chicago, IL: AMA Press,2002.

Cruz-Sanchez, F.F. ‘‘Emerging Ethical Issues in Brain Banking.’’ European Com-

mission financed Ethical; Legal; and Social Aspects of Brain Research, 1997.Available at: http://www.iprs.it/brainelsa/BACKUP_cd/banks1–1ter.htm.

Department of Health and Human Services, Office of the Secretary. ‘‘Standards for

Privacy of Individually Identifiable Health Information.’’ 45 CFR Parts 160through 164. Available at: http://www.cms.hhs.gov/hipaa/hipaa2/regulations/privacy/finalrule/PvcTxt01.asp.

Department of Health and Human Services. ‘‘Human Cells, Tissues, and Cellular

and Tissue-Based Products; Establishment Registration and Listing.’’ FederalRegister 66 (January 19, 2001): Rules and Regulations. Available at: http://www.fda.gov/cber/rules/frtisreg011901.pdf.

European Group on Ethics in Science and New Technologies to the EuropeanCommission. ‘‘Ethical Aspects of Human Tissue Banking.’’ 11 (July 21, 1998).Available at: http://europa.eu.int/comm/european_group_ethics/docs/avi-

s11_en.pdf.Greely, H.T. ‘‘Breaking the Stalemate: A Regulating Framework for Unforeseen

Research Uses of Human Tissue Samples and Health Information.’’ Wake

Forest Law Review 34 (1999): 737–766.Hogle, L.F. Recovering the Nation’s Body: Cultural Memory; Medicine; and the

Politics of Redemption. New Brunswick, NJ: Rutgers University Press, 1999.Indech, B. ‘‘The International Harmonization of Human Tissue Regulation: Regu-

latory Control over Human Tissue Use and Tissue Banking in Select Countriesand the Current State of International Harmonization Efforts.’’ Food and LawJournal 55 (2000): 343–372.

Josefson, D. ‘‘Human Tissue for Sale: What Are the Costs?’’ Western Journal ofMedicine 5 (2000): 302–303.

Josefson, D. ‘‘US Hospitals to Ask Patients for Right to Sell Their Tissue.’’ British

Medical Journal 321 (2000): 653.Mahoney, J.D. ‘‘The Market for Human Tissue.’’ Virginia Law Review 86 (2000):

163–223.


Martin, J.B., and D.L. Kasper. ‘‘In Whose Best Interest? Breaching the Academic-

Industrial Wall.’’ New England Journal of Medicine 343 (2000): 1646–1649.Medical Research Council Working Group to Develop Operational and Ethical

Guidelines. ‘‘Human Tissue and Biological Samples for Use in Research.’’ (April

2001). Available at: http://www.mrc.ac.uk/pdf-tissue_guide_fin.pdf.Murray, T.H., and M.J. Mehlman, eds. Encyclopedia of Ethical; Legal; and Policy

Issues in Biotechnology. New York: John Wiley and Sons, 2000.

National Organ Transplant Act, 1984. Pub L. No. 98–507, 3 USC *301.Nelkin, D., and L. Andrews. ‘‘Homo Economicus: Commercialization of Body

Tissue in the Age of Biotechnology.’’ Hastings Center Report 28 (1998): 30–39.

Swan, J.P. Academic Scientist and the Pharmaceutical Industry. Baltimore: The JohnHopkins University Press, 1988.

Wagner, D. ‘‘Property Rights in the Human Body: The Commercialization of OrganTransplantation and Biotechnology.’’ Duquesne Law Review 33 (1995): 931–958.

Weir, R.F., ed. Stored Tissue Samples: Ethical; Legal; and Public Policy Implications.Iowa City: University of Iowa Press, 1998.

Womack, C., and N. Gray. ‘‘Human Research Tissue Banks in the UK National

Health Service: Law, Ethics, Controls and Constraints.’’ British Journal ofBiomedical Science 55 (2000): 250–253.

KEITH BAUERDepartment of PhilosophyMarquette UniversityU.S.A

SARA TAUBEthics Standards GroupAmerican Medical AssociationChicago, ILU.S.AE-mail: [email protected]

KAYHAN PARSINeiswanger Institute for Bioethics and Health PolicyStritch School of MedicineLoyola University ChicagoU.S.A


Ethical issues in tissue banking for research: a b

Documents

Transcript of Ethical issues in tissue banking for research: a b