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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