THE HISTORY OF INFORMED CONSENT

THE

HISTORY

OF

INFORMED

CONSENT

Peter

M.

Murray,

M.D.

University

of

Iowa

Department

of

Orthopaedics

Iowa

City,

Iowa

HISTORY

OF

INFORMED

CONSENT

Informed

consent

for

surgical

procedures

is

a

relatively

new

trend

in

the

practice

of

surgery.

For

thousands

of

years

physicians

felt-that

deception

was

an

integral

part

of

the

practice

of

medicine.

Over

the

last

150

years,

the

con-

cept

of

physicians

establishing

a

"standard

of

care"

has

gradually

been

replaced

by

the

idea

that

the

well-

informed

patient

can

be

the

master

of

his/her

own

body.

Thus,

the

practice

of

informed

consent

has

emerged

as

surgery

has

become

more

patient-oriented.

EARLY

HISTORY

In

ancient

Greece

patient

participation

in

decision

mak-

ing

for

medical

treatment

was

considered

undesirable.

It

was

generally

accepted

that

the

physician's

primary

task

was

to

inspire

the

confidence

of

the

patient

in

the

treat-

ment.

Any

disclosure

of

possible

difficulties

might

erode

patient

trust.

Later,

during

medieval

times,

medical

writ-

ing

encouraged

doctors

to

use

their

conversations

with

patients

as

an

opportunity

to

offer

comfort

and

hope

while

emphasizing

the

need

for

the

doctor

to

be

manipulative

and

deceitful.

To

effect

a

treatment

cure,

it

was

widely

felt

that

authority

must

be

coupled

with

obedience.9

During

the

Era

of

Enlightenment,

new

views

emerged

stating

that

patients

had

the

capacity

to

listen

to

the

doc-

tor,

but

it

was

still

felt

that

deception

was

necessary

to

facilitate

patient

care.

During

the

1800's

the

medical

pro-

fession

was

split

over

whether

to

disclose

a

dire

prognosis

to

a

patient.

However,

most

physicians

of

the

time

argued

against

informing

patients

of

their

condition.9

The

doctrine

of

assault

and

battery

has

its

roots

in

early

English

Common

Law.

This

Doctrine

forms

the

basis

for

the

possible

"injury"

or

"liability"

incurred

from

surgery

without

proper

consent.3

Common

Law

is

the

combination

of

customs,

traditions,

and

case

law;

it

is

distinct

from

legislative

law

which

is

law

enacted

by

a

governing

body.7

Many

of

these

English

Common

Law

doctrines

have

influ-

enced

our

tort

system

of

justice.

Assault

is

a

threat

by

one

person

to

do

bodily

harm

to

another

while

battery

is

the

actual

touching

of

a

person

by

another.

Therefore,

the

the-

ory

of

tort

battery

became

the

unauthorized

touching

of

a

person

by

another.3

As

the

concept

of

informed

consent

gained

popularity

during

the

twentieth

century,

the

courts

extended

the

English

Common

Law

Tort

doctrine

of

negligence

to

the

field

of

surgery

by

equating

negligence

with

breach

of

duty

and

breach

of

duty

with

an

incomplete

patient

con-

sent.

Currently,

the

failure

of

a

physician

to

provide

ade-

quate

information

to

the

patient

about

his/her

own

treat-

ment

is

interpreted

by

the

courts

as

a

breach

of

duty

by

the

physician.3'9

With

this

early

background,

let

us

turn

in

chronological

order

to

some

of

the

more

significant

legal

cases

of

the

twentieth

century

and

then

examine

how

these

cases

have

shaped

the

current

doctrine

of

informed

consent.

Luka

v.

Lowrie,

136

N.W.

1106,

Michigan

1912

In

this

case,

a

surgeon

believed

that

an

emergency

amputation

was

necessary

to

save

a

child

who

had

sus-

tained

a

crush

injury

to

his

foot.

Before

proceeding

with

procedure

the

surgeon

consulted

four

other

physicians,

all

of

whom

agreed

that

an

emergency

amputation

of

the

child's

foot

was

necessary.

The

child's

parents

were

unavailable

to

discuss

the

matter.

Subsequently,

the

court

ruled

that

if

they

had

been

available,

the

parents

would

have

agreed

with

the

need

for

an

emergency

amputation

when

informed

that

multiple

physicians

had

been

con-

sulted,

all

of

whom

agreed

with

the

need

of

an

emergency

procedure.

Schoendorff

v.

Society

of

New

York

Hospital,

211

N.Y.

215,105

N.E.

92,1914

This

case

has

had

probably

the

most

impact

on

the

doctrine

of

informed

consent,

and

first

established

that

the

patient

was

an

active

participant

in

the

treatment

deci-

sion

process.

In

this

case,

Justice

Benjamin

Cardozo

summarized

"every

human

being

of

adult

years

in

sound

mind

has

a

right

to

determine

what

shall

be

done

with

his

own

body;

and

a

surgeon

who

performs

an

operation

without

his

patients

consent

commits

a

battery

for

which

he

is

liable

in

damages".

Dicenzo

v.

Berg,

16

A2d

15,

Pennsylvania,

1940

In

this

case,

the

court

supported

the

defendant's

(the

physician)

attempt

to

supply

the

patient

with

a

description

of

the

procedure

to

be

performed

even

though

the

plaintiff

(the

patient)

was

not

pleased

with

the

outcome.

The

104

The

Iowa

Orthopaedic

Journal

The

History

of

Informed

Consent

patient

had

originally

consented

to

a

surgical

procedure

on

his

neck

but

was

quite

concerned

about

scarring

the

exposed

portion

of

his

neck.

After

the

surgery,

the

patient

felt

that

the

surgeon's

incision

and

subsequent

scar

were

inappropriate,

and

subsequently

brought

suit.

The

court

eventually

ruled

that

the

surgeon

must

be

given

sufficient

latitude

within

the

boundaries

of

the

patient's

consent

to

operate.

The

court

determined

that

the

surgeon

had

obtained

adequate

consent

from

the

patient

and

had

placed

the

incision

appropriately

and

therefore

should

not

be

liable.

Prince

v.

Massachusetts,

321

US

158,

1944

Early

in

this

century,

the

courts

established

a

concept

that

has

remained:

parents

cannot

refuse

treatment

to

their

children

on

the

basis

of

religious

beliefs.

In

this

case

the

Supreme

Court

stated

"Parents

may

be

free

to

become

martyrs

themselves,

but

it

does

not

follow

that

they

are

free,

in

identical

circumstances,

to

make

martyrs

of

their

children

before

they

have

reached

the

age

of

full

and

legal

discretion

when

they

can

make

that

choice

for

themselves."

Two

examples

are

members

of

the

Jehovah's

Witness

Church

denying

medically-necessary

blood

transfusions

to

their

children

and

Fundamentalist

Chris-

tians

in

southern

West

Virginia

requiring

children

to

han-

dle

snakes

during

worship

services

and

refusing

them

medical

attention

once

bitten.

In

both

of

these

situations

the

parents

would

be

subject

to

child

neglect

laws.

Bang

v.

Charles

T.

Miller

Hospital,

251

Minn,

427.88

N.W.

2d

186,

Minnesota,

1955

This

case

established

that

the

patient

was

entitled

to

know

inevitable

risks

or

results

of

surgery.

In

this

case

an

elderly

male

patient

consented

to

a

transurethral

prosta-

tectomy.

He

was

not

specifically

informed

prior

to

the

pro-

cedure

that

the

accepted

surgical

technique

would

in

all

likelihood

leave

him

sterile

post-operatively.

The

surgeons

in

this

case

were

found

liable.

Corn

v.

French,

71

Nev.

280,289

P.

2d

173,

Nevada,

1955

Corn

v.

French

established

that

the

surgeon

must

not

misrepresent

the

surgery

to

be

performed.

In

this

case,

after

examining

the

patient,

the

physician

advised

that

she

undergo

a

test

for

a

possible

malignancy

of

the

breast.

The

patient

subsequently

asked

the

doctor

if

he

intended

to

remove

her

breast,

to

which

the

physician

replied

"no".

The

patient

then

signed

a

written

form

consenting

to

a

"mastectomy"

even

though

she

received

no

explanation

of

the

procedure.

Inevitably,

the

physician

was

found

liable

for

an

unauthorized

procedure.

Natanson

v.

Kline,

350

P2d

1093,

Kansas,

1960

In

this

case

the

court

found

that

the

patient,

not

the

sur-

geon,

must

be

the

final

decision

maker.

The

final

sum-

mary

read:

'A

man

is

the

master

of

his

own

body

and

he

may

expressively

prohibit

the

performance

of

life-saving

surgery

or

other

treatment."

A

doctor

may

believe

that

an

operation or

other

form

of

treatment

is

desirable

or

neces-

sary,

but

the

law

does

not

permit

him

to

substitute

his

own

judgement

for

that

of

the

patient

by

any

form

of

misrepre-

sentation

or

deception.

Darrah

v.

Kite,

32

A2d

108,

New

York,

1969

The

verdict

in

this

case

established

that

each

invasive

diagnostic

test

requires

a

separate

consent.

This

lawsuit

resulted

when

the

parents

consented

to

having

their

child

admitted

to

the

hospital

for

"routine"

brain

tests

in

order

rule

out

a

developmental

disorder.

The

physician

then

pro-

ceeded

with

a

complete

workup

including

invasive

tests.

Ultimately,

the

court

ruled

against

the

physician

finding

that

"routine"

brain

tests

did

not

include

significant

inva-

sive

studies

and

established

that

patients

should

not

be

admitted

to

a

hospital

under

a

general

consent

of

admis-

sion

and

then

receive

a

wide

variety

of

invasive

diagnostic

tests

without

separate

specific

consents.

Green

Case,

296

A.2d

681,

Pennsylvania,

1971

In

this

case

the

court

authorized

blood

transfusions

for

a

Jehovah's

Witness

child

with

paralytic

scoliosis.

This

patient

had

a

940

curve

with

pulmonary

and

cardiac

impairment.

The

mother

consented

to

a

spinal

fusion,

but

refused

to

consent

to

any

blood

transfusions.

The

court

ruled

that

without

the

scoliosis

surgery

(and

the

incum-

bent

blood

transfusions)

the

patient

would

be

considered

under

state

law

a

neglected

child

because

he

did

not

receive

the

surgery

required

for

his

well-being.

Subse-

quently,

a

court-

appointed

guardian

authorized

the

scolio-

sis

surgery

and

subsequent

blood

transfusions.

In

re

Osborne,

294

A2d

372,

Washington,

D.C.,

1972

The

courts

have

traditionally

held

that

if

a

patient

with

dependents

refuses

a

blood

transfusion

necessary

to

save

his

or

her

own

life,

the

transfusion

can

be

given.

In

this

situation

an

individual's

religious

freedom

can

be

super-

seded

by

the

right

of

society

to

reduce

the

number

of

peo-

ple

on

welfare

and

attempt

to

preserve

the

family

unit.

Over

time,

however,

the

courts

have

developed

limitations

to

these

restrictions

based

mainly

on

the

doctrine

of

informed

consent.

An

example

of

this

is

the

Osborne

case

where

a

thirty-four-year-old

married

man

with

two

chil-

dren

was

severely

injured

when

struck

by

a

tree.

The

patient

refused

to

accept

blood

tr_nsfusions

on

the

basis

Volume

10

105

PM

Murray

of

religious

beliefs.

The

patient

was

deemed

fully

compe-

tent

and

expressed

the

desire

to

obtain

"everlasting

life"

rather

than

receive

a

blood

transfusion.

Subsequently

the

courts

found

that

his

wife

was

competent

to

run

the

family

business

and

provide

for

the

children.

Additionally,

if

the

wife

was

unsuccessful

in

managing

the

family

business,

then

the

wife's

parents

and

brother

affirmed

that

they

would

care

for

the

children

if

necessary.

The

court

then

could

find

no

obvious

interest

to

society

in

restricting

this

patient's

religious

freedom,

and

so

a

blood

transfusion

was

not

ordered.

Cobbs

v.

Grant,

502

P2d

1

California,

1972

Prior

to

this

ruling,

courts

in

most

states

had

upheld

the

prevailing

"standard

of

practice"

rule

with

respect

to

risk

disclosure.

The

decision

in

this

case

posed

the

more

lib-

eral

patient-oriented

concept

of

the

disclosure

of

risks:

"Had

the

patient,

judged

as

a

reasonable

and

pru-

dent

person,

been

provided

adequate

information

about

the

procedure

and

its

risks

prior

to

consenting

to

the

procedure,

or

if

some

material

risk

had

been

presented,

would

the

patient

have

refused

to

proceed

with

surgery?"

In

this

case

the

plaintiff

(patient)

underwent

surgery

for

a

duodenal

ulcer

and

an

artery

at

the

base

of

the

spleen

was

lacerated

resulting

in

splenectomy.

The

patient

had

not

been

informed

that

injuries

to

the

spleen

occur

in

approximately

5%

of

duodenal

ulcer

repairs.

Subse-

quently

the

patient

sued

for

malpractice

at

time

of

surgery

and

for

negligence

on

the

part

of

the

physician

for

failure

to

obtain

a

complete

informed

consent.

The

jury

returned

a

verdict

in

favor

of

the

plaintiff

and

assessed

damages

against

the

hospital

and

the

surgeon.

Canterbury

v.

Spence,

464

F2d

772,

Washington,

D.C.,

1972

The

courts

have

generally

affirmed

that

rare

risks

of

surgery

do

not

need

to

be

specifically

discussed

as

part

of

the

consent

unless

these

rare

risks

pose

critical

conse-

quences.

In

this

case

Mr.

Canterbury

sought

medical

treatment

for

back

pain

from

an

neurosurgeon,

Dr.

Spence.

Dr.

Spence

performed

a

myelogram

which

dem-

onstrated

a

filling

defect

at

the

T4

level

consistent

with

a

herniated

thoracic

disc.

Dr.

Spence

then

proceeded

to

rec-

ommend

the

laminectomy

which

was

performed.

Preoper-

atively

Dr.

Spence

did

not

provide

a

thorough

description

of

the

procedure

and

did

not

indicate

that

paralysis

was

a

known

complication

to

the

procedure.

Additionally,

he

did

not

indicate

any

alternative

methods

of

treatment

to

Mr.

Canterbury.

Mr.

Canterbury

underwent

an

uneventful

laminectomy

and

did

well

post-operatively

until

he

fell

from

bed

incurring

a

T4

complete

paraplegia.

In

the

law-

suit

that

followed

the

court

held

that

Dr.

Spence

had

been

negligent

in

obtaining

a

complete

consent.

The

court

also

stated

that

in

consenting

a

patient

the

following

must

be

included

in

order

to

assure

that

the

patient

has

adequate

knowledge

of

the

procedure,

the

diagnosis

and

differential

diagnosis,

required

diagnostic

procedures,

detailed

description

of

the

surgical

procedure

with

any

postopera-

tive

treatment

necessary,

the

risks

of

the

surgical

proce-

dure,

any

alternative

methods

of

treatment,

and

expected

results.

Richardson,

284

So.2d

195

Louisiana,

1973

The

courts

had

established

that

when

parents

grant

consent

for

children

the

procedure

to

be

performed

must

have

some

specific

benefit

for

the

patient.

In

the

Richard-

son

case

a

child

developed

renal

failure

requiring

renal

transplantation.

A

second

child

in

the

Richardson

family

who

was

mentally

retarded

was

deemed

a

renal

transplan-

tation

candidate

to

the

first

child.

The

court

later

ruled

that

the

parents

could

not

authorize

the

mentally

retarded

child

to

become

a

renal

transplantation

donor

because

there

was

no

specific

derived

benefit

to

the

mentally

retarded

child.

Reif

v.

Weinberger,

372

F.Supp.

1196,

District

Court

Washington,

D.C.,

1974

This

case

established

that

any

consent

given

under

physical

or

mental

duress

is

invalid.

In

this

case

tubal

liga-

tion

was

recommended

to

a

patient

on

welfare.

The

patient

was

also

advised

that

if

she

did

not

have

the

tubal

ligation,

her

welfare

benefits

would

be

significantly

reduced.

The

District

Court

of

Washington,

D.C.

deter-

mined

that

this

was

consent

given

under

duress

and

not

a

voluntary

consent.

The

consent

was

therefore

deemed

invalid

and

the

surgeon

was

found

liable

for

assault

and

battery.

In

re

Melideo,

390

N.Y.S.

2d

523,

New

York,

1976

In

the

Melideo

case,

Mrs.

Melideo

received

a

dilatation

and

curettage

of

the

uterus

for

diagnostic

purposes.

After

surgery,

she

developed

significant

bleeding.

Mrs.

Melideo

refused

blood

transfusions

on

the

basis

of

her

religious

belief

against

blood

transfusions.

Subsequently

a

court

order

was

sought

by

the

hospital

in

an

attempt

to

autho-

rize

a

transfusion

against

the

expressed

desires

of

the

patient.

The

court

determined

that

a

patient

may

decline

treatment

and

that

to

order

such

a

treatment

that

is

expressively

refused

by

the

patient

on

religious

grounds

would

be

a

violation

of

that

patients

constitutional

protec-

tion

of

religious

freedom.

Subsequently,

the

transfusion

was

not

ordered.

Robert

Quachenbush,

383

A2d

785,

New

Jersey,

1978

This

case

illustrates

that

medically

necessary

treat-

ment

other

than

blood

transfusions

can

be

refused

for

rea-

sons

other

than

religious

reasons.

Additionally,

this

case

106

The

Iowa

Orthopaedic

journal

The

History

of

Informed

Consent

points

out

that

a

patient's

refusal

of

medically

necessary

treatment

does

not

determine

competence

in

treatment

decisions.

Robert

Quachenbush

was

an

elderly

male

with

a

long

history

of

peripheral

vascular

disease

admitted

to

a

hospi-

tal

for

treatment

of

bilateral

lower

leg

gangrene.

His

tem-

perature

was

elevated

and

cultures

were

positive

for

clos-

tridium.

The

patient's

lower

extremities

were

black

and

drained

purulent

fluid;

however,

the

use

of

IV

antibiotics

produced

a

temperature

defervescence.

The

patient's

phy-

sician

recommended

bilateral

above

the

knee

amputations

on

an

emergent

basis.

Mr.

Quachenbush,

however,

stated

that

he

had

objected

to

most

medical

care

for

over

forty

years

and

subsequently

refused

the

recommended

surgi-

cal

debridements

and

amputations.

The

surgeon

believed

that

Mr.

Quachenbush

was

suffering

from

organic

brain

syndrome

and

presented

the

situation

to

hospital

adminis-

trators.

The

hospital

in

turn

petitioned

the

court

to

have

a

guardian

appointed

to

make

medical

decisions

for

Mr.

Quachenbush,

who

was

felt

to

be

incompetent

to

make

treatment

decisions

because

of

his

organic

brain

syndrome.

The

court,

however,

found

that

refusal

for

above

the

knee

amputations

interfered

with

the

accepted

medical

treatment

for

his

condition.

Mr.

Quachenbush

did

have

an

understanding

of

the

proposed

procedure

with

his

risk

in

expectations.

The

court

felt

that

Mr.

Quachenbush

had

a

valid

concern

about

the

risks

and

subsequent

rehabilita-

tion

after

bilateral

above

the

knee

amputations.

There-

fore,

the

court

found

the

patient

to

be

competent

to

decide

on

surgical

alternatives

and

ruled

that

the

amputations

could

not

be

required

based

on

the

right

to

privacy

under

Federal

Constitutional

Law.

Bech

v.

Lovell,

362

So.2d

802

Louisiana,

1978

The

State

Court

ruled

that

a

spouse

or

family

member

cannot

consent

for

surgery

in

place

of

the

competent

patient.

The

only

exception

to

this

situation

would

be

the

added

presence

of

a

medical

emergency

where

the

other-

wise

competent

patient

might

be

unable

to

participate

in

the

consenting

process.

A

family

member's

consent

for

an

otherwise

competent

patient

who

had

been

sedated

would

therefore

be

inadequate.

A

second

situation

that

could

arise

is

the

physician

obtaining

consent

from

a

family

member

because

the

unavailability

of

the

patient;

such

a

consent

would

be

considered

inadequate

based

on

this

ruling.

Truman

v.

Thomas,

27

Cal.3d

285,

California,

1980

Although

the

patient

has

a

right

to

refuse

tests

or

treat-

ment,

the

courts

have

established

that

the

physician

has

a

duty

to

inform

patients

of

the

risks

of

refusal.

In

Truman

v.

Thomas,

the

patient

rejected

a

family

doctor's

advice

to

have

a

pap

smear.

Subsequently,

on

repeated

occasions

the

family

doctor

recommend

a

complete

physical

exami-

nation

including

a

pap

smear.

The

patient

refused

each

of

these

pap

smears

and

the

physician

assumed

that

the

patient

knew

the

purpose

of

the

test

and

did

not

specially

discuss

with

her

the

risks

of

failing

to

have

the

pap

smear.

Eventually,

the

patient

developed

advanced

cervical

can-

cer.

In

the

lawsuit

that

followed,

the

California

Supreme

Court

overturned

a

lower

court

ruling

and

stated

that

the

physician

had

the

duty

to

disclose

all

information

to

patients,

including

the

possible

outcome

of

refusing

rec-

ommended

screening

tests

for

cancer.

Perna

v

Pirozz,

92

N.J.

446,457

A.2d

431,

New

Jersey,

1983

Surgery

performed

by

a

person

other

than

the

surgeon

named

by

the

patient

at

the

time

of

consent

constitutes

battery.

Additionally,

the

originally

authorized

surgeon

who

obtained

the

consent

but

failed

to

perform

the

surgi-

cal

procedure

is

therefore

liable

for

malpractice

on

the

basis

of

breech

of

duty.

Precourt

v.

Frederich,

395

689,481

N.E.2d

1144

Massachusetts,

1985

The

decision

handed

down

in

this

case

set

limitations

upon

a

physician's

duty

of

risk

of

disclosure

at

the

time

of

consent

and

could

be

interpreted

as

a

"Tort

Reform"

case.

In

this

case

a

patient

underwent

a

surgical

proce-

dure

on

the

eye

for

which

prednisone

was

given

post-

operatively

to

control

inflammation.

Subsequently,

the

patient

developed

aseptic

necrosis

of

both

hips

and

a

law-

suit

resulted.

Even

though

the

Physician

Desk

Reference

(PDR)

lists

aseptic

necrosis

of

the

hips

as

a

complication

from

prednisone

therapy,

a

witness

for

the

defense

testi-

fied

that

a

library

search

of

articles

on

the

subject

showed

no

reports

of

aseptic

necrosis

of

the

hips

developing

sec-

ondary

to

the

postoperative

use

of

prednisone

after

eye

surgery.

Therefore,

a

higher

court

overturned

a

lower

court's

jury

verdict

in

favor

of

the

plaintiff

stating

"in

this

case

there

was

no

evidence

of

the

likelihood

that

a

person

would

develop

aseptic

necrosis

after

taking

prednisone

or

that

Dr.

Frederich

knew

or

should

of

known

that

the

likeli-

hood

was

other

than

negligible.

Large

v.

Superior

Court

of

Arizona,

714

P.2d

399,1986

This

case

demonstrates

that

competence

for

consenting

to

surgical

procedures

may

differ

significantly

from

the

competence

necessary

to

execute

other

activities.

In

Large

v.

Superior

Court

of

Arizona

a

women

with

organic

brain

syndrome

and

poor

cognitive

function

was

admitted

to

the

hospital

with

a

hip

fracture

subsequent

to

a

fall.

The

risks

and

expected

outcome

of

surgical

repair

for

hip

fracture

was

discussed

with

the

patient

by

the

operating

Volume

10

107

PM

Murray

surgeon.

At

that

time

the

patient

was

felt

to

understand

the

material

presented

and

subsequently

consented

to

the

procedure.

At

the

same

time

she

executed

a

will

in

the

presence

of

a

lawyer.

Postoperatively,

the

patient

died

and

both

the

consent

to

surgery

and

her

stated

will

were

reviewed

by

the

court.

The

court

found

that

the

will

was

invalid

due

to

her

lack

of

testamentary

competence

(the

patient

did

not

know

the

extent

of

her

property

or

her

fam-

ily

members).

However,

the

surgical

consent

was

consid-

ered

valid

by

the

court

because

the

patient

was

able

to

understand

the

procedure,

its

risks,

and

potential

benefits.

Younts

v.

St.

Francis

Hospital,

469

P2d

338

(1986)

In

many

states

adolescents

over

fourteen

years

of

age

are

considered

adults

with

the

right

of

privacy,

confiden-

tiality

and

competency

to

consent

to

surgical

procedures.

In

Younts

v.

St.

Francis

Hospital

a

seventeen

year

old

girl

presented

with

a

distal

phalanx

tuft

fracture

and

skin

avulsion

after

trapping

the

finger

in

a

car

door.

The

girl's

mother

was

under

general

anesthesia

at

the

time

of

her

injury

and

her

father

(divorced

from

the

mother)

could

not

be

located.

After

several

attempts

to

locate

the

father

the

procedure

to

be

performed

was

explained

to

the

patient

along

with

its

risks,

benefits,

and

alternatives.

She

subse-

quently

consented

to

the

procedure

but

a

lawsuit

followed.

Ultimately,

the

court

held

that

the

patient,

even

though

she

was

a

minor,

understood

the

nature

of

the

surgery,

possible

risks,

and

potential

benefits.

Therefore,

the

con-

sent

was

found

to

be

valid.

With

the

above

case

decisions

in

mind,

some

conclu-

sions

about

the

doctrine

of

informed

consent

can

be

drawn.

Whenever

a

physician

obtains

a

consent

from

a

patient,

that

physician

should

be

mindful

of

the

conditions

necessary

for

informed

consent,

the

information

require-

ments

necessary

for

an

informed

consent,

patient

compe-

tence

in

delivering

his/her

own

consent

and

how

consents

in

an

emergency

situations

may

be

obtained.

CONSIDERATIONS

FOR

VALID

CONSENT

As

viewed

by

the

courts,

a

consent

is

the

authorization

by

a

patient

to

have

a

certain

medical

treatment

or

sur-

gery

performed

on

that

person.

A

consent

may

be

expressed

or

implied.

An

expressed

consent

is

one

that

is

either

written

or

spoken

by

the

patient.

An

implied

con-

sent

is

one

demonstrated

by

the

acts

of

a

patient.

An

example

of

an

implied

consent

might

be

the

presence

of

a

patient

in

an

examining

room

of

a

doctor's

office.

Although

this

patient

has

not

formally

said

or

written

that

he

or

she

consents

to

a

physical

examination

by

a

physi-

cian,

he

or

she

is

present

on

his

or

her

own

free

will

and

offers

no

resistance

to

examination.

Therefore,

a

complete

consent

form

is

not

a

legal

paper

but

merely

a

documenta-

tion

of

the

patient's

expressed

desires

for

medical

or

surgi-

cal

treatment.

For

a

consent

to

be

valid

it

must

be

obtained

from

a

knowledgeable

patient

who

understands

the

procedure

to

be

performed,

as

well

as

that

procedures

risks,

complica-

tions,

and

possible

alternatives.

Additionally,

the

consent

must

be

voluntarily

given

and

not

received

under

duress

or

threat.

Most

importantly,

the

consent

must

be

given

by

a

patient

who

is

deemed

competent

to

offer

a

medical

consent.3

INFORMATION

NECESSARY

FOR

A

CONSENT

In

Canterbury

v.

Spence

464

F2d

772

Washington,

D.C.

1972,

the

court

held

that

the

consent

must

address

six

different

information

requirements

for

the

patient

to

be

truly

informed.

1)

The

patient

must

be

aware

of

the

diag-

nosis.

2)

The

patient

must

be

aware

of

any

diagnostic

pro-

cedures

necessary

to

ascertain

the

diagnosis.

3)

The

sur-

gical

procedure

must

be

described

in

a

way

that

the

patient

understands.

4)

The

patient

must

be

informed

of

any

inevitable

risks

from

surgery

(frequent

outcomes

of

surgery)

and

any

collateral

risks

(any

complication

arising

indirectly

as

a

result

of

surgery).

5)

The

patient

must

be

informed

all

alternative

methods

of

treatment

both

surgi-

cal

and

conservative,

and

6)

the

expected

results

and

their

probability

should

be

discussed

in

sufficient

detail

with

the

patient

prior

to

surgery.

CONSENTING

COMPETENCE

For

a

patient

to

consent

to

a

surgical

procedure

or

a

medical

treatment

he

or

she

must

be

deemed

competent

from

a

medical

point

of

view

which,

as

pointed

out

earlier,

may

differ

significantly

from

a

legal

point

of

view

(Large

v.

Superior

Court

of

Arizona,

714

P2d

399,

1986).

The

patient

is

considered

medically

competent

and

able

to

give

consent

when

that

person

understands

the

procedure

to

be

performed,

appreciates

the

reason

for

the

proposed

procedure,

and

is

aware

of

the

risks

of

the

procedure

and

the

expected

outcome.

If

the

patient

is

considered

incom-

petent

to

give

a

consent,

the

consent

may

be

obtained

from

the

next

of

kin

(mother,

father,

wife,

sibling,

or

child)

or

the

statute

of

parens

patriae

may

be

evoked

by

the

courts.

A

statute

of

parens

patriae

allows

the

court

to

appoint

a

guardian

for

a

patient

for

the

purposes

of

medi-

cal

decision

making.

Historically,

children

have

not

been

considered

incom-

petent

to

make

medical

decisions;

however,

in

some

states

adolescents

fourteen

years

or

older

are

considered

adults

for

medical

consent

purposes.

Exceptions

to

the

historical

trend,

however,

include:

1)

children

or

adolescents

who

are

pregnant,

2)

children

or

adolescents

who

are

parents,

3)

children

or

adolescents

deemed

self-reliant

in

that

they

108

The

Iowa

Orthopaedic

Journal

The

History

of

Informed

Consent

are

living

away

from

home

and

are

independent,

4)

chil-

dren

or

adolescents

who

are

members

of

the

Armed

Forces,

and

5)

adolescents

who

are

considered

mature

minors

being

financially

independent

and

self-reliant

despite

living

at

home

with

parents.1

EMERGENCY

CONSENT

There

are

certain

exceptions

to

the

previously

men-

tioned

criteria

for

a

valid

informed

consent.

Such

excep-

tions

exist

for

emergency

consenting.

In

this

situation

the

physician

may

proceed

with

treatment

without

formal

con-

sent

from

the

patient.

This

exception

to

the

formal

con-

sent

process

was

created

based

on

the

understanding

that

the

patient,

if

able,

would

consent

for

the

proposed

proce-

dure.

However,

frequently

certain

situations

arise

where

severely

injured

patients

cannot

give

consent

and

family

members

are

unavailable.

In

these

situations,

treatment

frequently

cannot

be

delayed

and

it

must

be

assumed

by

the

physician

that

the

patient

or

the

family

would

provide

authorization

for

the

proposed

treatment

given

the

urgency

of

the

situation.

It

is

generally

felt

that

for

the

physician

to

proceed

in

an

emergency

situation

without

consent

the

following

must

exist:

1)

a

true

medical

emer-

gency,

2)

the

physician

is

truly

unable

to

obtain

consent

from

the

patient

or

next

of

kin,

3)

the

proposed

treatment

is

for

the

ultimate

benefit

of

the

patient.2

CONCLUSION

The

doctrine

of

informed

consent

is

a

relatively

new

idea

in

the

history

of

medical

practice.

The

ancient

practi-

tioners

of

medicine

adopted

a

paternalistic

attitude

towards

patient

care,

and

seldom

involved

the

patient

in

the

decision-making

process.

In

the

18th

and

19th

centu-

ries,

the

concept

of

assault

and

battery

arose

from

English

Common

Law

and

established

the

idea

that

the

surgeon

must

receive

authorization

from

a

patient

before

perform-

ing

surgery

or

otherwise

be

liable

for

breach

of

duty.

Dur-

ing

the

20th

century,

various

legal

decisions

have

gradu-

ally

swung

the

pendulum

from

a

paternalistic,

"standard

of

care"

decision

making

approach

to

a

more

patient-

centered

concept:

"a

man

is

the

master

of

his

own

body...

",

(Natan-

son

v.

Kline,

350

P2d

1093,

Kansas,

1960).

A

valid

consent,

then,

represents

the

evolutionary

pro-

cess

from

paternalistic

medicine

to

patient-centered

medi-

cine.

The

consent

must

be

given

voluntarily

by

a

compe-

tent,

knowledgeable

patient

who

understands

the

proposed

treatments

with

their

incumbent

risks

and

alternatives.

BIBLIOGRAPHY

1

Becher,

Virgil,

Jr.:

The

Informed

Consent

for

the

Sur-

gical

Procedure:

Competence

to

Consent.

Contemporary

Orthopaedics,

17:6,

pp.

21,

1988.

2-

Becher,

Virgil,

Jr.:

The

Informed

Consent

for

the

Sur-

gical

Procedure:

The

Exceptions

to

the

Rules.

Contempo-

rary

Orthopaedics,

18:2,

pp.

138,

1988.

3-

Becher,

Virgil,

Jr.,:

The

Informed

Consent

for

the

Sur-

gical

Procedure:

An

Introduction.

Contemporary

Ortho-

paedics,

17:1,

pp.

15,

1988.

4-

Becher,

Virgil,

Jr.:

The

Informed

Consent

for

the

Sur-

gical

Procedure:

Knowledge

Requirements.

Contempo-

rary

Orthopaedics,

17:3,

pp.

15,

1988.

5-

Becher,

Virgil,

Jr.:

The

Informed

Consent

for

the

Sur-

gical

Procedure:

The

Ramification

of

Jehovah's

Witness

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