Citation: 40 J.L. Med. & Ethics 359 2012

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Attendin to Patients Need ntbe nfnoried Consent Process&l Siegal, Richard J. Bo 5, and Paul S.A;

[ntroduction: Impediments toInformed Consent[n an explicit attempt to reduce physi

the inft

he

ase

Fh<Sf

sent procec

ofrelevant

ter

:St

4e

h~ISE

cel

tor

>f decisions thatcorollary obligat:ilitate patient auit have been crea

ibodis shoi

ssary health literacy a)hysicians' disclosures,iStics,6 and other beh

ial" decision-making?Iapacity to understand

nake choices that accth~

relate to their bodiesion of physicians - totonomy - is reflected

ted to implement con-5E isclosi

aftHowever, there a

to patient self-deter

to live up to

deliberation

g physiof faciliby thei

tel

D LL.B., S.J.D.,Virginia School Ofzlth Law and Bioelr Researcher at thed. Richard J. BoSrofessor of Medic

ractical

healthns ofter

ftIsi

Sift

sO sulnd ab1

ssft

the Sibe info

addressed

Dfthe inft

to compreh<

h~ave cast doubte disclosed infttely reflect thei

if these

e is another

consent do(

flow of infcPhysicians have thiake educated decisD not.9 The acceptetr this information isclosure of specifieome states have ad

standinfor:theirto knto the

e infc

ed infoloptedning tl

Eion that shoultors ("what wo

to make a deciasonable physi

ent 0 prior to trea

Thatever the sta:rd the

Sc

LL.B.,nd L(

tion, the re,the informabe in a posi

S.

id Law, and theychiatry in theD,rsity andNew H

ibl1

Eh

is rel

iake, she

bst

vb

thhe

be

cian" stainible physi

by theasonab1

>able patie:vhile others

Edard ("wha

>f informatiis that given

it will be ab1rant to her ch

hat to

ifwhen pre.,fer to this

assistance

Eh

rei

EGHT TO

lbaum

car(becheainfco

s<

a ft af

Ssuccessf

e very heick of pati<

hysithe nwhenperso

Gil Sil

te<hysi

ta mealicy i7>unda,

ychia:- Polic,id Pu

ofby

Ifch

dry and 1Py, and B5lic Polielum, M.Ty, Medi

sclosi

inforr

eify

E

hher decisi

astive infoi

tei

HeinOnline -- 40 J.L. Med. & Ethics 359 2012

informs - i.heloft

whAt

sto

forbedis

for

ch

th

fen earacterizeifortunately, th,n-making is n<(reasons we dl

tween doctorsplaced by a sty*M.

obstf gei

Dften re

ribe bE

ifoth

bEthat is

les the IrFhis is on

tine "informedcess rather tha-rocess of inf

sh.)fr

The Ritual of InformedConsentMost agree that the commonplace ritu

0nsent - focused as it is on the prigning of a consent form - has manyfrom the patient's perspective, what sh(tive, personalized process of receivingnformation and seeking clarification oination has become standardized anhysicians attempt to comply with a du

be

them (w]easonableercise a ri

iat the int(1patientsing rules

for inwoul,avoicdtion ,for jusubj

on inof the

hichpati

be

ght not to kno

erests of both- have to be tfor informaticalized or "subjIe physicians w

tbility for faili

isst

ableWhen the problem

ized disclosure migh,law's effort to formu

the current approaclrisk of physician liabconsent. To the con

uncertain what is ethat accept the "reas

when standardizedby professional bodcourts have occasioentitled to other inft

ure to disclose inforr

in those cases amoui

consent, thereby cre

ible" r-inforrfrom i

te diffE0nt to k

.One might sa)arties - physLken into accoia disclosure. A

thoto

hEof disclosi

for infori

ais viewed in thus way,t be seen as a logical ftlate a predictable rulh has by no means eliiility for failure to obtaatrary, many physicikxpected of them, eveonable physician" staldisclosures have bee

lies or risk managemnally ruled that the 1

>ersonagrelevanature oSreasoiasent"i

-actice. Instea(ngful dialogutoo often beeg and signing

ial of informeesentation an

flaws.12Vieweould be an iteand absorbin

r further inford inflexible, aity to inform a,ner. As a resul-d, while otherat is importannt than what

IS

unt in foriSrequirerred disclost3ictical wavhat inforl-now. Ind(y rejected-e that fociation in fi

L st

ffft vaueo tconfet 5

t. fp

fE-dictb fity andoshaki

valueinofmtin the et

oei f a information rb

n to be insufficient. Unc

Df systan

profe

hE

,1t

rs

a3ble toponse,

-ders,5 concur

mptoms, degridard disclosureassional associce time of the rnsum, obtainirended to becoin which physiee of uncertainnt"), and ofter,nts lack conti

leaving themrelative to theiinformation t1unwanted infeevant issues, 16

iscule risks,7to their real -*A

because preocthe disclosurEwhole exercise

)f cons(

lard- haf the h

amatect thei informedis are still.1 in statesdard. Eveni endorsed

if

Of(Suc

.ons)licalthe

)rofessional <ccess. As a r(bombardin,

ation ("overlatient's neecdng such an <(close some r

axposing theis retrospecti,rtainty is als'esentations-reatments, Imedical lite

itidence in tf11t, some phitheir patieni"), which stior despairirn-:ensive discleaimal amouielves to liabi

hl

hcis tnose re(

0applicable

teraction.

ttient's inft

A byrbidernslaked byuate

zet

,ians are obeyucope ("be cer

acting deferE1 over the fboth for be

.decisional newan they need irmation can dileave them urn

nd possibly le,fshes. This is

cupation with'makes physi(often awkwar

>faith

mportantly,1sent are mao

:come has al0der to ascer

re altered the

1t for physic1ients would h

nly the inforjuries, like e,"hindsight bsince a risk 1the patient wsition of liabiconsecluence

onstruct

about t

ns of in

Dspect, w

vh

an ethto infty, and>f infoi

ds and of receivinr desire. This su .tract them fromIluly worried aboxuid to decisions c(all the more distthe "legal sufficit-ians cvnical abc

E

bd. A)f sp

patient's decision, t1-ians to counter patave chosen a differer

mation had been avayone else, are influe" - i.e., the tendentterialized, if told ab

Id have chosen differiT in these cases has siboth

fail- to laintiffs

to a fa

0 to a given p

to obtain infe hirs msurance,

ssed in this

.m of inforr

legalyourrhich

ift

f nf

-bi

th

patLient's wish

quate inform(r the unwantethis stage, it-ification wou

is making it d'nts' claims thcourse of acticAble. Judges aiced by a stroito believe th

it it in advant-itly.19 The impfificant financienages award(the subseque-miums.

vhethE

OURNALOf

s<

>f

a

if-

ini

iniie(rhcrei

s

f

5i

t

,ver,ias"

O

HeinOnline -- 40 J.L. Med. & Ethics 360 2012

between the flow of inft

tection for ofhe consent fisclosure pr

rivey the resignificant

teith<

:es hysiended course of tr

ssion and hand thE

staff membETer the form. What we are pro

compatible with - and shove the consequences of - a

seauences.

ftSE

st

st

chieving Personalie aim to shift genuineocess to patients, anocess by overcoming

ed Disclosureontrol over the informationa

I to facilitate a personalize(both the information asymrelevance problem. By per

fonalizing the processof SE

nation, our proposal woul

heir desire for informationhis approach rests on re

n their level of risk aversit

ences (be th,law of inforrthese variati,sider, for exaof a proposeiwritten desc:come or, to t]sicians shoul,

elves in medical infes of self-efficacy, anc

important decisions,nees may be embedc1

ceiving infor-rts to specify

iffeto

cal

hisul qn

ssesf

>a fi

te<sugA introduced to <(

1sent to medicalk key feature of <(it from patient

,nee for informa

>s-

>f

thisor rwhic

ss or

d written consent. Howe,to be useful in this contex

>f h

h

:a:

>f

is toS1l

how much todisclosure (oft

fl

rs to

Lhcultural inf

-based).21 Ttped to reflthem.22 C

>ho

.e patient and shoul

him- or herself. Theght be described, iri on demand" (IOD)tients should be able

is

tersrfa

Rec11 bE ab1

S eddbsr rheect dslsr opte011-ges tgeI rthe

Se 1: ffra7e-The first stage of itered model of inft

:es;arclmg the ways n

sent is integrate(

arse

iscl

>ss

ofoSu:

ster

formula for obt,be

o her (oft(zing thate to imphcess immeans of whi-ts can be

if

h

sitional St(

if

be modifie<

certed effort toir overall pref-for specificity.

ar's seat, rathersponsibility ofIting in either

Lion of.Yal defef3

nt a fully in(tely, we suggethe goal of oieved.

p Forward

isclosure is,,

dshift>f patic

be helpful to consi

self-idenl

which th

Zal

ifted to signal his or Elude to the disclosur

>f

ify their status by seev -pass: reen (no th

(carrying items on which customsSimilarly, patients during this

be

the naturebeing perff

rniste<

IS(

rdesire for infor-process. It mightwalking throughThere passengersthe aisle through

Asi

to pronounceIi aisle (basic inf<>f procedure/trermed, when thE

bE

nust be paid).tional phaseI for informa-s offered suchthe reasons itcan return to

Lea to

1hi

vhi Is(

L's

hysicians.

ift:er

Sie al.ABonnie, andAi

rs, the physi

bl th

thfe

Eeiffe

to

st

be sh

si

th

by

>syncratt

nsent shther thai

:a

d not be reqtd for inforrr

d from the ],are proposirm. as "infor:

take theirapproachshorthanThe fund:

ft

if

mong physivhich the foa

a%,,ge sigmt ias and speoility of obi

hysite

terbefc

EGHT TO

lu

-I

HeinOnline -- 40 J.L. Med. & Ethics 361 2012

's lifEinformation isrisks of the p:iand frequencyaisle (extensiiitems that onlirelevant).

Standardized,Stratification cwill require dilmedical procEmight choose.ing task, it sh<the material iring consent ft

>SE

ve infoy a sm

blue aisle (where moiding major/significa

,nt defined by severiltbout alternat)rmation is p

all number of

bl ssentially th

efault, bu a patient sh:hoice to as

his

FbOne

seems

"basic"offfE

ic

isl

te contel

t stanaaraize

for each "aiFugh this is a

10t be too bi

roposea

isclosure

that thittedly a

ation mn each categSeen as a collaboi

11 stakeholders shoLg medical professicitient advocates to

ipproach-for each

temn on thespecially th(lisclosure (on of the pr(

zer

che to extractfrom exist-

ve effort tobe involved

0s to provide

ure accessi-

>Sa

would be asked ifabout alternatives aPrompting this optitence of alternative

eflect what mosthat can be testlist of disclos

orny. As indicathe green aisleoposed procedu

I consequences,

entation of altecedure, which sclosure (the blatients who ch<

if so,>ffersren if

ible patient" starould be told this ak for more (red) citinuity with existt patients probab1Led).ures (alternativested in Table 1, thI) would includere, the reason for ibut would not inirnatives to the retbe described in th

1S1

rst (green) tle informati<I be describe

teEif

LU

to advise ab

personanizeimade by thof disclosur

being retrothas statedtaken placeinformed ci

WO~L11 Ut11U

hysician's stanprocess can bEpatient reganare binding -

hishe

fe :es and th

disclosure for the "ha ns the nhysi

to theuld beSE

she has selected. When thmust provide accurate inforquestion, irrespective of thllegally sensible to make th

failed to provide hitHe calDf risl<

choice

it claim im retrospectversion is different frfor information disc'

f procedure/ I. Basic description of alternatives 1. ExtensivE

t 2. Major/significant risks of proposed about thE

being recommended treatment and alternatives, defined procedurs without treatment by severity and frequency 2. ExtensivEtient can resume about alt

ife activitie Extensive into

about possiblife

abeIrnatives

ves the "right

:he risks of trcScontent of thi

tible withidard or th

thc

nbli

it are designedze liability exp<

bethe

abli

cl

OURNAL O

si

Dl

hensioinuatibi

Disclostbe embodiwritten orsent form:

he

e according1 in physiciher materi-is well. Ofibout a top

these th

o

rse

ifaf

cesST

h

s

h

Ifcth

hhat his perslm that sign

>sure he ha

bv

ifil

:ivE

Mil

cive IC

HeinOnline -- 40 J.L. Med. & Ethics 362 2012

Siegal. Bonnie. andAl

rhere the cht cates perssician is in no positioy

tryngeal cancer, whichradiotherapy, with sin

but with very differer

Isle is so

LO uue pm

as a physiinformatii

("Just tell me wha

ofRight to Be Info?t be permissible t

Sthe right to be inhear that stuff. Ji)? Although stron

the sbth sides. Nft

gent. We ackn<

Eaditionally hasisclosure of infc,ased on the ide

t to

J bet's 1

by

's ob1ia cha .to tel

ible ifike to

th gate Secist

esponsibili

iscomfort

ter

o

to the conset

and the alterhvsician.

it's de:

ces of

od

oE hfor

should beeclines, tovledge thatecognized anation. Buithat some

tEbe'

ife

L's

og

th th

se to the p

atient's desig

rmed consel

lnt's right toving such wa

face ifrbi

to

hto delegate decisi

If the psent to

this ch

chooses tooposed tre;

tails the r(comfort th

to

ifto

b

al

bi

n sun

ffers

ted SEto physi

td positiveaw tionship

lst

Stage oft rst

is

Lai

ations for th

is

with physicia:

'fe

)al cos1

5sclosur<

rtant ste]ther tha

poseossib1

tai

is

dcflEir

h

se

to an agen

ority to con

believe thEconfront thwith makinide informa

iseauences of I

tage 2: Fully Individuadvances in information t(acilitate a highly personal

m of individualizing co

nteractive software.2 For Eas proposed a particular c

abc

has explained thterms, the physie1a CD, flash drive

bsi

lized Disclosureechnology will eventuallyized solution to the prob-nsent disclosure througxample, once a physiciaourse of treatment to the

ft y stheter-link toa

ed infond altei

atient physicallhave babies) -ure of which cale. We are also i

ternatives to thenimum disclosi

vill lose

sed to p

ved by s(to includ

thosE

af

present purposes, we

agent designated by thL patient lacking decisi

ability to navigate heEhine nroram. The t

)f inter

Patient or acting on behalfEal capacity) has the cogni-

way through an interactivehing (software) program

iduals to specify their level

formation, but would pro-

[GHT TO

,while prourrent infcs. It bearsess should

fr

nsent transeag both paritional exchaphasis, thou;

b1

3h,

be personsurance t1

,the patielie interactof switchi

that the phyL's

thEto bl

si A Tor by90%),t's life.

,an be trilar survit impactit choose

1, suchtted byil rateson theto del-

burden is shift

to

set of in

or, if th

bchoosE

>se

),C1

hEisclos

In ais

of altE

HeinOnline -- 40 J.L. Med. & Ethics 363 2012

vide hypertext link,-that would enabledemand (IOD), bcMuch as museumcan elect whethernumber of topicsviewing, patients tflexibility and cont

Use of informatrol over the flow,opportunities to recomprehension. Aopportunity to exatechnologies to theA software prograrafter completing twith the disclosur(readability at an,they had sufficien-(and possibly the rpatient consistentla need for legallyEto be assumed bydecision maker.

After the patientized disclosure proirequests for inforrthe patient and th(with the physiciantions can then enstion of consent. Ththe personal qualitship, but it also seia patient claims ii"I should have rec

script wictual b(

rat materhe mismaformatioLrong infeTas not reever the c

be rto r

info

ill showehavior.:ified hyllized whi-h betweand his :mnce that1vant tousal link

tients to obid on their :sitors who Fhear more

Fated to theoFwould hav

ation technologyof information ascview the informatdditionally, theretmine the applicati<understanding sid,m can be written inthe educational mire, patients could8th grade level) t(t understanding o-isks, benefits, and;ly "fails" such a tes-effective decision-ran adeauately inf(

cess, tilmationLe physi

regarsue, fo1iis appity of th,rves arn a leg-eived

wheth(If it sh

Fertextm giveren his

thehirne

.ce in informed conL appears that expi-e for informed cowever, a fully devemodality for achiesort is probably st

0equired to assure t]

educe the risk that I

0rmation, and to op

tel

cauld be(Ln. A p(ig anyred bych is inatient-

aportaiactionlitionaler his (ows thclinks Ir

els of spa infornividualit an autail abc:hibitioi,similar

;hip-

a-nthte

phntafSillait

at

th

Lisms

ine-trs to

>f

a substalAf develo

e ofsuc

odultake

o assf thaltert, it Imaki

orm(

suct" ofavail,sona.aans,e fondeaysic-lega'Fter tnforfim ihe d

associateoa mini-tes.ss whetheprocedur

iatives). If,aight signog authoritJ surrogat

the patient'sable to bothl interaction-wered ques-rmal indica-d to preserve

1ian relation-tl purpose. Ifthe fact thatmation," theis backed bydid not open

b to the risksnity to do so,

so

bi

AddrThe ptify an(for el'potenmore,answ(desig

probltinuirable isituatcateg<of eacalternmulat

Ske

the trpotenit neying pawe wi

of theindepthe pibe strpatie

unsop

will need to be available to allow physune" the disclosures, and the substantuse IT in medical practice will have toIn the meantime, however, the "trai

Dn" outlined above - admittedly a snie that reflects a serious effort to achievt control over the flow of information diat process - can be implemented.

0

essing Possible Objectionsersonalized process enables the patientd select the informational sets she carvcample, inevitable consequences as op-tial risks, frequent side effects as opremote chances of complications), and trs to her individual concerns. Undened computer-assisted process, the "rem" is solved completely by the patieg opportunity to demand and probe t

formation to ascertain its applicabili

lbh catep

iatives)Led for

ft

ft

als to s

II beair plenderospeonglnts w)histiiSby tl

hF

and (if3sary fo:litigati<ients wiat are a

S(

rses of

ces would shat the infounrebutted

osi

afo

>f

Fth

ormation technonalized disclosi

rs away. Researccarram is user-frie

rst

h,

soft

ee

>f 5

>f

closing the11 advances iy, doubts aboit overlook t)f already oco

I- mation by

of informationevery procedurihree aisles.ht claim that,stage, what w(urrecting or reimedical paternelect options shiraging them toans by renderi,

.nt choice. This cact that informaty related to soci,ho are relatively.cated, poor, sociahe medical systerant of informati(yree of health litevill seek and rec)n.these concerns v

Fses. First, our proirrent ritualized p

promote choi

disparities in praiad, to the contrarhealth literacy gC

ifonFul

th

siciialbensi

ba

tio

I si

i proposal, it is solved,tely. Thus, the content(mainly about risks or,e would have to be for-

, particularly duringe harbors the

nforcing (as many feelalism - i.e., by allow-iort of "full disclosure,"

rely on the judgment.ng them incapable of-zern is exacerbated by-seeking behavior willtatus and education:ducated, uninformed,

, 5

Llly vulnerable, andm are likely to receon, while patientseracy and socio-ect-eive the highest 1I

Tery seriously, but vposal offers abetterpractice which is noce. Moreover, it do(Lctice any worse thcery, provides a platftap in the long run t.

. technolog.6cts for patient E

ted transformaacquisition of ipowered health

d, browerme.that h-al info

th

>f

>ffer,tionaallynottheyi forugh

OURNAL O

to

Te greateruring the

Lto iden-res about)posed toposed to

to receiver a well-

elevance,nt's con-he avail-ity to her

hclthtinstws

l

e

h

e

ou

i

encchysic

s

lei

ad infxpers

HeinOnline -- 40 J.L. Med. & Ethics 364 2012

Siegal. Bonnie. andAl

s consumers of othe

atients are frequentlyf information they ne<nteraction that we enyLively to specify the inft

Second, we envisionlevelovping the standal

phases of implementacounteract concerns

or about bridging thEStandardized disclos

f so

entifyherefo

isensus-b cI disclosui

)bout professi

Dur approachhoices rather

cess forag bothshould

chs s hould be

high(

h collaborationsducators, and ot

is no materialandertaken so

are organizal

ment. We thereftthat allows the gtinct areas of sur,

able demonstratis

erst

vhel

lostrba

thb(

ison foiby the

.s. Such

Yher stakeholders. Ther

at educational task to beical profession or heald

b effort wouhd professional commit

:fvh

2r point of concern c<(defeated, rather tha

ized approach - i.e.,even in the transitior

:hoice about the levelt. Implementation of aFrcess with multile b

that reac>ssibility th

we suspect thwould encou2ffect as thesi3, way of corn

tF

:ar

ing stdiffertinuemraticto col

ntal process hat>sure in dis-provide reli- of "ais

1d be that pempoweredhey might bEI stage by ha:f informatioomouter-bas

by the rle over- ac.ving to Pan that med dis- b

Pt

a bid exc- o 0

h

re that the bodies of kn

ent categories of standato reflect updated sciein in an accessible fash .duct research on indivisire for information gericare decisions in partieserve patients' opporttles" as they proceed argenuine preferences.ing depersonalization)nship, we stress the n(1prior to formally sigits should be having t'

to ft

cai afso

the numbee attentioipproache

Flling theithe risk-a,

informahe high,hvpert

Fht to obtractice se-

flecaft

will not be largeto this possibleLre tested. Of ccanxiety, some

rse default posa protective starDfinformationa

Lag

:se

The Path AheadWill personalized d

information corid medical infcis also importa-ifferences bearii

to

As for

of theSf-1

Feed position, thvhat is importabeing floodedmation.

isclosure elimi

', ana to assuito alter theirAt the choicethe concerr

ch

st

hysieed for a personal n

Fning the consent frs

th

afa

te inftrse, as sent litigat

>f

Fhif

' choices and respec-mation. Moreover, ft1 of disclosure is wh

accept this approachge, since it would refr

ftIsi

rst

i refinementation of aing disclosi

n some states to"

f failing to seek

a five lecact)sal could bet of existin

yal:edly be a choctrine that ht is possible tbdemented by t]

ter-assisted modality fc

ibts abcI inforr

legal effetGiven th

EGHT TO

rs Dftel

As ( 1c1

>f

ase t

withthe

are whethe

tempts to gn for nPatiei

fr<rfe

avoid the effort iwhether our proor-patient relati

concerns must bE

our sugges

ierate betterF, as physici

lisclosures a

rsonalizes datsal ne

ishis.

is

se

tl

HeinOnline -- 40 J.L. Med. & Ethics 365 2012

achproantibe i

eving theosal wort-ipated at

indertakeugh subsiis to lay d

,ertainty, and o

In o m t o eeceive. It is ]ppromote moreLions mn many clifficult to ach:

a

,gal cha-ay haverst sight.will deltial behvn a nev2Ad to em,hieve gr(lients wa,ssible tIneaning]ses, a de.ve by ot1

[us "4malpractice ies necessary to mrnore sanguine fu

rhether such effornd on "proof oforal research. Ou,aradigm of informy

wer patients, enhaer congruence betand the informathis approach c(

patient-physiciainable outcome that, means.

refoiSake

turets sh

:h

r modestaation onnce legal

Lween thetion theyould alsoiinterac-has been

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