INFORMED
CONSENT
TO
HUMAN
EXPERIMENTATION
KEM THOMPSON
BIOETHICS
PROFESSOR DANIEL BENSON
DECEMBER 3,
1982
TEXAS TECH UNIVERSITY
TABLE OF CONTENTS
I.
II.
III.
IV.
V.
VI.
VII.
Preface
i
Pre-Nuremberg Code Cases
1
The Nuremberg Code
5
Other Codes,
Doctrines,
and L e g i s l a t i o n
7
Post-Nuremberg Code Cases
11
A.
Battery Actions
21
B.
Negligence Actions
22
(1.)
The P h y s i c i a n ' s
(2.)
Affirmative
Functions of
Duty
23
Defenses
26
the D o c t r i n e of Informed Consent
28
A.
I n d i v i d u a l Autonomy
28
B.
Rational
29
D e c i s i o n Making
Legal Limitations
on an I n d i v i d u a l ' s
Ability
to Consent
.
.
30
Conclusion
32
The Nuremberg Code
Appendix
I
The D e c l a r a t i o n o f H e l s i n k i
Appendix
II
PREFACE
The law of informed consent
and e x p a n s i v e
topic
legal standards
subjects
that involves
Many c o u r t s ,
such as f e t u s e s ,
issues,
paper.
of
the law i n
While
it
page l i m i t a t i o n s
examination of
such as p r i s o n s ,
is
important
restrict
the h i s t o r y ,
on informed consent
these
to human
to the
types o f
legal scholars,
and other
infirm.
to recognize
the coverage of
The
research
have
than normal
an
the scope
the e x i s t e n c e of
such
this paper to a g e n e r a l
and current s t a t u s of the
experimentation.
other
subjects,
Unfortunately,
i s beyond
and
tried
in areas i n v o l v i n g
and o t h e r areas
development,
is a broad
complicated i s s u e s .
consent
c h i l d r e n , and the mentally
in-depth a n a l y s i s
this
as w e l l as
the meaning and e x e r c i s e of
than normal e n v i o r n m e n t s ,
of
a number of
for consent vary according
involved.
to deal w i t h
to human experimentation
law
Teaming the art of h e a l i n g with s c i e n t i f i c
medical
and
research i n human b e i n g s
ethical
consent.
issues,
most of which
This paper attempts
ments of informed consent in
reviewing j u d i c i a l ,
gives
in o r d e r
the e v o l v i n g doctrine of
attitude
focus on
the concept of
informed
the l e g a l
and e t h i c a l
and l e g i s l a t i v e
require
actions.
during
to gain a h i s t o r i c a l
consent,
by
The
for bringing legal
dramatic s h i f t s
informed
topics,
toward human
legal
and the requirements
Therefore,
into s i x principle
to a number of
the area of human e x p e r i m e n t a t i o n
as a r e s u l t of i t have undergone
centuries.
for
rise
to assess
administrative,
view o f human research
investigation
each of which d i s c u s s e s
action
the l a s t
perspecitve
this paper i s
law
two
of
divided
the l a w ' s
changing
experimentation.
I.
Human e x p e r i m e n t a t i o n
Pre-Nuremberg Code
Cases
may be d e f i n e d as " t h e
d e v i a t i o n from stan
dard medical procedures f o r the primary purpose o f o b t a i n i n g new
1
knowledge."
The f i r s t a p p e l l a t e court o p i n i o n a d d r e s s i n g the i s s u e
2
was
decided in England i n 1 7 6 7 .
had invoked an unorthodox method
complications
healed,
this
from a broken l e g .
a bulge
l e g and e x t e n d i t ,
ill
the
and had not
patient
to h e a l a p a t i e n t who had
When the p a t i e n t ' s
formed c a u s i n g a l i t t l e
c o n d i t i o n was not u n u s u a l ,
and lengthen
The case i n v o l v e d a surgeon who
decided
using a heavy metal device with
leg.
After
recovered
damages a g a i n s t
four months,
leg
Although
to rebreak
teeth
and h i s
The jury
associate,
the
to s t r e t c h
the p a t i e n t was s t i l l
from the p r o c e d u r e .
the surgeon
broken
protuberance.
the surgeon
suffered
very
awarded the
an
apothecary.
The a p p e l l a t e
court,
on two f a c t o r s .
first
affirming
First,
time the metal
acted rashly
of h i s
device
Second,
of h i s p l a n b e f o r e
verdict,
based its
the court determined that because
and i g n o r a n t l y
actions.
the j u r y ' s
opinion
this was
and procedure had e v e r been u s e d ,
and thus was
the surgeon
he rebroke
responsible
should have
the p a t i e n t ' s
f o r the
the
the
surgeon
consequences
informed the
leg so that
the
patient
patient
3
could " t a k e
courage"
to undergo the
operation.
4
Neitiier of the
Physicians
because
court's
points
is
c o n s i d e r e d good law
today.
are no l o n g e r s u b j e c t e d to absolute
a procedure was done f o r the f i r s t
l i a b i l i t y merely
5
time, nor i s the r a t i o n a l e
6
s u p p o r t i n g informed
However,
consent
the B r i t i s h
very much a part of
Approximately
court's
to enable
a patient
concerns of
the law on human
to " t a k e
rashness
courage".
and consent are
still
experimentation.
a century l a t e r in 1 8 7 1 ,
a New York
court
confronted
a s i m i l a r case i n v o l v i n g treatment of a d i s l o c a t e d arm.
I n Carpenter
7
B l a k e , a p h y s i c i a n r e l o c a t e d a p a t i e n t ' s bones but f a i l e d to inform
him that h i s
arm s h o u l d e i t h e r be h e l d on a p i l l o w
f o r a p e r i o d o f time o r remain in a s l i n g .
v e r d i c t at
that
verdict
angle
G i v i n g such advice
p a t i e n t was c o n s i d e r e d s t a n d a r d medical p r a c t i c e .
awarded a jury
at a right
of two thousand d o l l a r s ,
to a
The p l a i n t i f f
an extremely
v.
was
sizeable
time.
Notwithstanding
the d e f e n d a n t - p h y s i c i a n ' s
s h o u l d be a l l o w e d to try new methods o f
argument
treatment,
that
the court
doctors
ruled:
I f the case is a new one, the p a t i e n t must trust to the s k i l l
and e x p e r i e n c e of the surgeon he c a l l s ; so must he . . . [ i f ]
there i s no e s t a b l i s h e d mode o f treatment.
But when the case
is one as to which a system of treatment has been followed
f o r a long time, there should be no departure from i t unless
the surgeon who does i t is p r e p a r e d to take the r i s k of estab l i s h i n g , by h i s s u c c e s s , the p r o p r i e t y and s a f e t y of h i s
experimen t -
The rule p r o t e c t s the community a g a i n s t r e c k l e s s experiments, w h i l e i t admits the adoption of new remedies and modes
o f treatment only when t h e i r b e n e f i t s have been demonstrated,
or when, from the n e c e s s i t y o f the c a s e , the surgeon or physician must be l e f t to the e x e r c i s e of h i s own s k i l l and experience . 8
At l e a s t one commentator has suggested
is " p r o b a b l y
that
the Carpenter
court's
rule
too s t r i c t
r e g a r d i n g common a i l m e n t s , and too l e n i e n t re9
diseases."
N e v e r t h e l e s s , t h i s rule was followed by the
garding novel
10
Colorado
jury
Supreme
verdict
of
Court
five
r e c i t e d the language
[I]f
in 1895 in Jackson
thousand
dollars
from C a r p e n t e r ,
a p h y s i c i a n sees
fit
v.
Burnham.
against
Affirming
a physician,
the
a
court
stating:
to experiment w i t h some other mode,
he should do so at h i s p e r i l .
I n other w o r d s , he must be
a b l e , in the case of d e l e t e r i o u s r e s u l t s , to s a t i s f y the j u r y
that he had reason for the f a i t h that was in him, and j u s t i f y
11
h i s experiment by some reasonable
Other
courts have also
theory.
treated e x p e r i m e n t a t i o n
and departure
s t a n d a r d medical p r a c t i c e as improper.
I n Sawdey v. Spokane
12
Northern Railway C o . ,
The Washington Supreme Court n o t e d :
Falls
from
&
[The doctor] must not experiment in his treatment of the i n j u r y .
On the c o n t r a r y , i f he d e s i r e s to a v o i d l i a b i l i t y f o r h i s mist a k e s , he must treat i t by some method r e c o g n i z e d and approved
by h i s p r o f e s s i o n as the most l i k e l y to produce favorable r e s u l t s
The Sawdey
court,
however,
as to the proper method o f
be l i a b l e
over the
explained
that when a d i f f e r e n c e of
treatment e x i s t e d ,
f o r an " h o n e s t mistake
14
other.
in judgment"
the p h y s i c i a n would not
i n s e l e c t i n g one procedure
W h i l e a number of e a r l y
cases emphasized
the
s t a n d a r d medical p r o c e d u r e s ,
no United S t a t e s
court
consent as a p r e r e q u i s i t e
when a M i c h i g a n
man s u f f e r e d
court
opinion
importance of
discussed
the
to performing experimental procedures
15
decided Fortner v.
Koch.
In Fortner,
from a swollen knee and a p h y s i c i a n d i a g n o s e d
following
patient's
until
1935
an e l d e r l y
the
condition
as bone
cancer.
the c o n d i t i o n
the p a t i e n t
of the knee
great p a i n .
p h y s i c i a n who,
suffering
The p h y s i c i a n p r e s c r i b e d i n j e c t i o n s which
the
wound f i n a l l y broke open
Subsequently
recovered s h o r t l y
tests,
The p a t i e n t was
16
thereafter.
causing
the p a t i e n t c o n s u l t e d a second
a f t e r performing various
from s y p h i l i s .
acknowledged
until
worsened
On a p p e a l ,
d i s c o v e r e d the man was
treated f o r
the d i s e a s e
the Michigan
Supreme
and
Court
the imp'ro.tance of performing standard d i a g n o s t i c
testing,
stating:
We recognize the f a c t t h a t , i f the general p r a c t i c e of medicine
and surgery i s to p r o g r e s s , there must be a c e r t a i n amount o f
e x p e r i m e n t a t i o n c a r r i e d o n ; but such experiments must be done
w i t h the knowledge and consent o f the p a t i e n t or those respons i b l e for him, and must not vary too r a d i c a l l y from the accepted
method o f p r o c e d u r e . 1 ^
Fortner is s i g n i f i c a n t
in which experiments were
they were not " t o o
Prior
to F o r t n e r ,
inasmuch as i t i s
recognized
radical"
the f i r s t Airerican
as l e g i t i m a t e procedures
and were performed with
case
providing
the p a t i n e t ' s
consent.
any e x p e r i m e n t a t i o n was presumed to be r e c k l e s s or
care-
18
less
and p l a c e d the burden of proving
Cases
present
d e c i d e d a f t e r Fortner
day j u d i c i a l
reversing
the s t a t e ' s
thinking.
licensing
reasonableness
on the
contain more l e n i e n t
I n Stammer v.
authority,
experimenter.
standards
and
19
Board o f R e g e n t s , the
reflect
court,
stated:
T h i s doctor e f f e c t e d a cure when so-called orthodox methods of
treatment had f a i l e d and now he has been p u n i s h e d f o r i t .
It
i s not fraud or d e c e i t f o r one already s k i l l e d i n the medical
a r t , with the consent o f h i s p a t i e n t , to attempt new methods
when a l l o t h e r known methods of treatment had proved f u t i l e
and l e a s t of a l l when the p a t i e n t ' s very l i f e has been d e s p a i r e d
of.
I n i t i a t i v e and o r i g i n a l i t y should not be thus e f f e c t i v e l y
s t i f l e d , e s p e c i a l l y when undertaken with t h e . p a t i e n t ' s f u l l
knowledge and c o n s e n t , a n d as a l a s t
r e s o r t . — —
Thus,
Stammer s i g n a l e d the advent of
doctors'
a new approach
use of novel medical procedures
and
to d e a l i n g w i t h
treatment.
II- The Nuremberg Code
During World War I I ,
engaged
a number of German p h y s i c i a n s
in " m e d i c a l e x p e r i m e n t s "
victims.
Following
the w a r ,
on m i l l i o n s o f
twenty-three o f
and
scientists
concentration
camp
these i n d i v i d u a l s
were
21
tried
for " w a r crimes a g a i n s t humanity" by an I n t e r n a t i o n a l
22
23
Tribunal.
The Nuremberg Code, which was a r t i c u l a t e d i n the
opinion,
deals w i t h many of
the various p r o c e e d i n g s .
The Code undoubtedly
comprehensive statement on
24
mentation"
adopted and
the p r i n c i p l e s
the d e f e n d a n t s '
issues
argument
that
of
court's
raised
represents
the law of informed consent
and has been w i d e l y
After discussing
accept
the moral and e t h i c a l
Military
during
the "most
to human
experi-
promulgated.
the Code,
the court
refused
t h e i r experiments w i t h
to
civilians
25
and p r i s o n e r s of war did not o f f e n d the e t h i c s
of
I n support o f
drew the c o u r t ' s
their
contention,
to a number of p r e v i o u s l y
and m a l a r i a .
The
court,
p u b l i s h e d experiments
rejecting
types of medical experiments
w e l l - d e f i n e d bounds
the d e f e n d a n t s
this
on p l a g u e ,
argument,
on human b e i n g s ,
conform to the e t h i c s o f
the medical
profession.
attention
venereal
h e l d that only
when kept w i t h i n
diseases,
"certain
reasonably
the medical p r o f e s s i o n
gen-
26
erally."
The Nuremberg Code e x p l a i n s
human e x p e r i m e n t a t i o n
may take
its
of
and l e g a l
issues.
dogma i s i n d i v i d u a l
this
factor,
the " b o u n d s " w i t h i n
which
place.
The Code i s b a s e d on p r i n c i p l e s
ethical,
and d e f i n e s
of natural
The most fundamental
consent.
law and addresses
moral,
concept i n t r o d u c e d b,y
The c o u r t , emphasizing
the
importance
stated:
1.
The voluntary consent of the human s u b j e c t i s a b s o l u t e l y
essen t i a l .
This means that the person i n v o l v e d should have l e g a l
capacity to give consent; should be so s i t u a t e d as to be able
to e x e r c i s e f r e e power of c h o i c e , w i t h o u t the i n t e r v e n t i o n
o f any element of f o r c e , f r a u d , d e c e i t , d u r e s s , o v e r - r e a c h i n g ,
o r o t h e r u l t e r i o r form of c o n s t r a i n t or c o e r c i o n ; and s h o u l d
have s u f f i c i e n t knowledge and comprehension of the elements
of the s u b j e c t matter i n v o l v e d as to enable him to make an
u n d e r s t a n d i n g and e n l i g h t e n e d d e c i s i o n .
This l a t t e r element
r e q u i r e s that before the acceptance o f an a f f i r m a t i v e d e c i s i o n
by the experiemntal s u b j e c t there s h o u l d be made known to
him the n a t u r e , duration and purpose of the e x p e r i m e n t ; the
method and means by which i t i s to be conducted; a l l inconv e n i e n c e s and hazards reasonably to be e x p e c t e d ; and the
e f f e c t s upon h i s h e a l t h or person which may p o s s i b l y come
from h i s p a r t i c i p a t i o n in the e x p e r i m e n t .
The duty and r e s p o n s i b i l i t y for a s c e r t a i n i n g the q u a l i t y
o f the consent rests upon each i n d i v i d u a l who i n t i a t e s , d i r e c t s
o r engages i n the experiment.
I t i s a p e r s o n a l duty and respon
s i b i l i t y which may not be d e l e g a t e d to another with i m p u n i t y .
In summary,
the Nuremberg Code requires
full
a four-part
test
of an experimental
consent.
to assure
According
competent,
the v a l i d i t y
to the Code,
voluntary,
The d e c i s i o n of
informed,
disclosure
the i n d i v i d u a l ' s
and
the Nuremberg
and imposes
subject's
consent must be
understanding.
tribunal
i s viewed by legal
scholars
28
as part of i n t e r n a t i o n a l
such law in
that s t a t e
the U n i t e d S t a t e s
courts
manner they apply
national
perhaps
is
customary or common l a w .
law i s
more
a federal
may apply
i s supported by a u t h o r i t i e s who
international
common l a w .
function
determined by f e d e r a l
view would r e s u l t
Nevertheless,
in
that
d e a l i n g with
courts
foreign
the same
of
inter-
law
and thus should be
courts.
The
latter
law b e i n g appealed to
thereby
allowing
the
the
Court
a uniform l a w .
At l e a s t one commentator has n o t e d
accepted,
argue
of i n t e r n a t i o n a l
and be b i n d i n g on s t a t e
grounds
of
s c h o l a r s who m a i n t a i n ,
affairs
i s s u e s of i n t e r n a t i o n a l
law i n
the v a l i d i t y
the a p p l i c a t i o n
Supreme Court on f e d e r a l question
29
to e s t a b l i s h
customary
r e j e c t e d by more contemporary
reasonably,
The v a l i d i t y
"the
result
is
that state
that
courts
r e g a r d l e s s which view
could adopt
and apply
is
the
principles
of
the Nuremberg Code as a b a s i s
a g a i n s t a r e s e a r c h e r who v i o l a t e d
the second v i e w ,
federal
in c i v i l
the p r o v i s i o n s o f
a researcher violating
offense.
for criminal
i t has been u t i l i z e d
the various
the Code would be g u i l t y o f
functions
as authority
by only one United S t a t e s
court.
in
the Nuremberg Code may
the area of human
In Kaimowitz
v.
32
Mental H e a l t h , a case i n v o l v i n g a p y s c h o s u r g i c a l
in evaulating
experimental
necessary
Invoking
the Code could be used by American
31
involving negligent experimentation.
Notwithstanding
that
the C o d e . "
In a d d i t i o n ,
litigation
determined
prosecution
30
the Nuremberg Code was
the s u f f i c i e n c y
brain surgery.
of
f a c t o r s - competency,
the
standard
for the
court h e l d
voluntariness,
serve,
experimentation
procedure,
the consent o b t a i n e d
the
courts
Michigan Department
an appropriate
Accordingly,
a
court
to
use
proposed
that
and knowledge
of
three
- must
33
be p r e s e n t
in order for the informed consent
While
the Nuremberg Code r e c o g n i z e s
for dealing with nontherapeutic
questions
no guidance
for
treatment of
distinction
the p a t i e n t
accumulation of s c i e n t i f i c
however,
help
it
falls
For example,
f o r future experimental p r a c t i c e s .
make a m e a n i n g f u l
between c l i n i c a l
from research
knowledge.
valid.
a number of
research,
on human e x p e r i m e n t a t i o n .
to be
rudimentary
short of s e t t l i n g
the Code gives
Moreover,
the u n s e t t l e d
Ill.
Various
Other Codes,
international
have proposed o t h e r codes,
tne s a f e g u a r d s
law r e l a t i n g
the unresolved
to c l i n i c a l
Doctrines,
to
primarily
the
issues,
the Code
to
investigation.
medical
organizations
and doctrines which e l a b o r a t e
to be observed by p h y s c i a n s
-7-
for
or
and L e g i s l a t i o n
and n a t i o n a l p r o f e s s i o n a l
guidelines,
little
research performed
are addressed by other sources which emerged a f t e r
develop
all
it neglects
conducted p r i m a r i l y
Many of
principles
and other c l i n i c a l
on
investigators
104
before
u n d e r t a k i n g human e x p e r i m e n t a t i o n .
Association
In 1 9 6 4 ,
the World
35
formulated the D e c l a r a t i o n of H e l s i n k i ,
ment on informed consent which d i s t i n g u i s h e s
therapeutic
clinical
research.
Medical
a comprehensive
between
state-
t h e r a p e r t i c and non-
The f o l l o w i n g y e a r the b a s i c tenets
of
the d e c l a r a t i o n were adopted by the American Medical A s s o c i a t i o n in the
36
form of e t h i c a l g u i d e l i n e s .
I n a d d i t i o n , a number of n a t i o n a l p r o f e s s i o n a l
bodies
i n c o r p o r a t e d these p r i n c i p l e s i n r e g u l a t i o n s , d i r e c t i v e s , and p o l i c y
37
memoranda.
O f a l l these q u a s i - l e g a l mandates and d o c t r i n e s , the most
influential
source o f
authority
government and i t s h e l a t h
the p o l i c y
and procedure
to a l l grantee
39
for
Essentially,
support of
nary
Included in
is
i s s u e d by the
that was i s s u e d by the Surgeon
38
in 1966.
The statement set forth the
rights
of i n d i v i d u a l s
federal
this body o f m a t e r i a l
statement
the Surgeon G e n e r a l ' s
i n v o l v e d in
is
General
requirements
clinical
research.
d i r e c t i v e p r o v i d e d that no grants
research were to be awarded or continued u n t i l an
in
interdiscipli-
committee comprised of tae e x p e r i m e n t e r ' s i n s t i t u t i o n a l a s s o c i a t e s
40
c o n s i d e r e d proposals
was
the
the United S t a t e s
agencies.
institutions
review to i n s u r e
in
for
charged with making
welfare
of a l l s u b j e c t s
research i n v o l v i n g human s u b j e c t s .
three b a s i c d e t e r m i n a t i o n s :
involved in
that proper methods of o b t a i n i n g
the
risks
41
fits.
of each procedure
Similarly,
dum o u t l i n i n g
the N a t i o n a l
various
normal
clinical
informed
consent are
are p r o p o r t i o n a t e
Institute
(2)
and
protected,
(2)
and ( 3 )
to the p o t e n t i a l medical
that
bene-
(NIII) a l s o i s s u e d a memoran42
and informed consent p r a c t i c e s
required
including:
of Health
(1)
all
00301
up to pass on
research p r o j e c t s
t h e r a p e u t i c or d i a g n o s t i c s t u d i e s
- 8 -
committee
the r i g h t s
invoked,
A system of review committees was set
activities,
volunteers,
that
the experimentation are
the group c o n s i d e r a t i o n
43
for each i n s t i t u t e .
(1)
The
involving
using
unusual
hazard,
and
(3)
nondiagnostic,
cedures
f o r making
were i n s t i g a t e d .
three
(2)
records of e x p e c t a t i o n s
Moreover,
requirements
informed
regulations
and ( 3 )
and informed consent of
research program:
freedom o f
institutions
The
requirements
set out in
group
of
consideration,
to withdraw
from an
and c l i n i c a l programs model t h e i r
of
the N I K d i r e c t i v e ,
Surgeon G e n e r a l ' s p o l i c y
great impact on the s t a t u s
of human e x p e r i m e n t a t i o n
i n l i g h t o f the magnitude of
ment through
patients
the presence
(1)
the s u b j e c t s
the
especially
Pro-
time.
Many research
a f t e r the N I H .
of p a t i e n t s .
the NI1I statement emphasized
i n any c l i n i c a l
consent,
experiment at any
nontherapeutic studies
the NIH f o r medical
together w i t h
statements,
in
Federal
grants
the
have a
the U n i t e d
funds p r o v i d e d by the
research.
practices
States,
federal
and
govern-
contracts
44
are
the l a r g e s t
Until
free
the e a r l y
source of money
1960's
federally
from f e d e r a l r e g u l a t i o n of
menter and the human s u b j e c t s .
issued their directives,
"parameters
federal
on a c c e p t a b i l i t y
for b i o m e d i c a l
research
funded medical
the
since
Another primary source of f e d e r a l
between
for
research
the FDA w i l l
research
regulations
The 1 9 6 2
amendments
new drug experiments
(FDA),
grantee/experi-
Education,
by p r o v i d i n g
accept as e v i d e n c e
research
and W e l f a r e .
to i t s
45
The
powers
research,
and
through
standards
47
of the s a f e t y o f d r u g s .
FDA
48
t h e i r informed consent.
the appropriate
Drug,
to the Act added the requirement
a a O ^ O
i g u o w
the
subjects.
r e g u l a t i o n o f biomedical
also emerged from the Fbod,
give
the
on human
department was a u t h o r i z e d to regulate the area pursuant
46
under the P u b l i c S e r v i c e s Act by making rules governing
the Food and Drug A d m i n i s t r a t i o n
essentially
come to e s t a b l i s h
research"
comes from the former Department of H e a l t h ,
States.
the Surgeon General and NIH
r e g u l a t i o n s have
of biomedical
the United
research was
relationship
However,
in
and Cosmetic
that
In 1 9 7 1 ,
Act.
all subjects
the FDA
of
augmented
the
regulation
to require
review by an i n s t i t u t i o n a l
committee of
all
49
clinical
investigations
Most a u t h o r i t i e s
began w i t h
committee
of new drugs i n
agree
that
a 1 9 5 3 NIH p o l i c y
responsible
humans.
federal
that
regulation of
research
r e q u i r e d p r i o r approval by a
for the p r o t e c t i o n o f human s u b j e c t s
in
programs
review
any
research
50
i n v o l v i n g human b e i n g s .
ment o f H e a l t h ,
formal
The Surgeon G e n e r a l ' s
Education
r e g u l a t i o n s were
r e g u l a t i o n s were
fetuses,
later
and W e l f a r e ' s
first published in
amended to i n c l u d e
the
Federal R e g i s t e r .
regulation
pregnant women and in v i t r o f e r t i l i z a t i o n .
and regulatory
congressional
subjects,
activity
efforts
culminating
in
the area may be a t t r i b u t e d
to e s t a b l i s h
in T i t l e
which became law on July
12,
P r o t e c t i o n of Human S u b j e c t s
the Commission's
guidelines
in
I I of
19 74,
federal
the f o l l o w i n g
In
1974,
These
involving
The i n c r e a s e d
in large part
attention
to
to p r o t e c t human research
52
the N a t i o n a l Research A c t .
Title I I ,
c r e a t e d the N a t i o n a l
of Biomedical
Commission
and B e h a v i o r a l
Research.
make recommendations,
53
i n v o l v i n g human
regulations
of research
Depart-
a commission
duty to i n v e s t i g a t e ,
for research
Current
setting
policy
requirements and the
51
guidelines followed.
define
for
the
It
and
develop
the
research
is
experimentation.
informed consent in
manner:
[T]he knowing consent of an i n d i v i d u a l or h i s l e g a l l y a u t h o r i z e d
r e p r e s e n t a t i v e , so s i t u a t e d as to be able to e x e r c i s e free power
of choice without undue inducement or any element of f o r c e , f r a u d ,
d e c e i t , d u r e s s , or other form o r c o n s t r a i n t or c o e r c i o n .
The b a s i c
elements o f information n e c e s s a r y to such consent i n c l u d e :
(1)
(2)
(3)
(4)
(5)
A f a i r e x p l a n a t i o n of the procedure to be f o l l o w e d , and
t h e i r p u r p o s e s , i n c l u d i n g i d e n t i f i c a t i o n of any procedures
which are e x p e r i m e n t a l ;
A d e s c r i p t i o n of any attendant discomforts and r i s k s
reasonably to be e x p e c t e d ;
A d e s c r i p t i o n of any b e n e f i t s reasonably to be e x p e c t e d ;
A d i s c l o s u r e of anv appropriate a l t e r n a t i v e procedures
that might be advantageous for the s u b j e c t ;
An o f f e r to answer any i n q u i r i e s concerning the procedures
and
(6)
In a d d i t i o n ,
An i n s t r u c t i o n that the person is free to w i t h d r a w h i s
consent and to d i s c o n t i n u e p a r t i c i p a t i o n in the p r o j e c t
^
or a c t i v i t y at any time without p r e j u d i c e to the s u b j e c t .
the s t a t u t e p r o s c r i b e s
through which the s u b j e c t
nis
legal
liability
rights,
is made to w a i v e ,
i n c l u d i n g any r e l e a s e
55
for n e g l i g e n c e . "
must be f u l l y
According
documented in at l e a s t
may o b t a i n e i t h e r a s i g n e d w r i t t e n
elements or a s i g n e d
written
ments have been o r a l l y
institution's
of e i t h e r of
date
(1)
that
to the
one of
Apparently,
If
three w a y s .
the r i s k
and
f o r human s u b j e c t s
experiments.
rather
However,
any
The
(3)
language
any
of
agents
consent
to the s u b j e c t
physician/researcher
all
necessary
that a l l of
is minimal;
the
ele-
advantageous
drafted
these
post-Nuremberg
that
use
invali-
attaining
57
the
a protective
view
shield
for researchers who p e r f o r m
Code case law s u g g e s t s ,
a prerequisite
the
involved.
r e g u l a t i o n s with
formal consent is p r i m a r i l y
than a s a f e g u a r d
(2)
means o f
to the s u b j e c t
the
method,
consent would work to
that any a l t e r n a t i v e
from
acquired
o r by any o t h e r method approved by
that o b t a i n i n g such consent i s
i n malpractice
or i t s
consent i s o b t a i n e d by the l a s t
the l e g i s l a t u r e
the documentation of
among
to a v o i d i n g
the
other
liability
litigation.
IV.
I n post-Nuremberg
Post-Nuremberg
Code c a s e s ,
from " s t a n d a r d medical procedure"
to e x p e r i m e n t a t i o n .
perceptions
regulations,
the o t h e r two methods o f o b t a i n i n g
important o b j e c t i v e s ,
things,
the i n s t i t u t i o n
consent form i n d i c a t i n g
these o b j e c t i v e s would be l e s s
that
of
or to appear to w a i v e ,
consent form c o n t a i n i n g
transmitted,
56
review b o a r d .
board must f i n d :
the use of "any e x c u l p a t o r y
Generally,
their
emphasis
to concerns w i t h the s u b j e c t s '
courts have
investigation.
Cases
courts seem to s h i f t
of medical e x p e r i m e n t a t i o n
forms of s c i e n t i f i c
Code
transformed t h e i r
as " q u a c k e r y "
previous
regarded
58
With one notable e x c e p t i o n , a p p e l l a t e
e
| ] i i u*
- i i -
^
to newly
consent
court o p i n i o n s
i n v o l v i n g human e x p e r i m e n t a t i o n have become
scarce s i n c e World War I I .
in
The h a n d f u l of
this e r a may be c l a s s i f i e d
nontherapeutic
Perhaps
in
cases
two groups:
relatively
that have been
decided
t h e r a p e u t i c experiments
and
experiments.
the b e s t case i l l u s t r a t i n g
the p r i n c i p l e s i n v o l v e d i n the
59
t h e r a p e u t i c e x p e r i m e n t a t i o n f i e l d i s Baldor v . Rogers , a cancer treatment
60
case
in which the p l a i n t i f f ,
expressly
telling
a farmer, had cancer of
the surgeon that he d i d not want s u r g e r y ,
was
t r e a t e d w i t h drug i n j e c t i o n s
the
treatment
f o r approximately n i n e
the cancer spread and the p h y s i c i a n
s e n d i n g him home.
the l i p .
The p l a i n t i f f
then brought s u i t
on grounds of wrongful e x p e r i m e n t a t i o n
comments on the proper
role of
the j u d i c i a r y ' s
mentation.
stated:
The court
the
plaintiff
months.
Despite
d i s c h a r g e d the
against
and abandonment.
the medical p r o f e s s i o n
cancer are i n d i c i a o f
After
new p e r c e p t i o n
in
the
The
patient,
physician
court's
the f i g h t
of medical
against
experi-
[W]e b e l i e v e the p i v o t a l q u e s t i o n i s w h e t h e r a p h y s i c i a n who
uses a method o t h e r than x-ray, radium and surgery in t r e a t i n g
c a n c e r , by that act a l o n e , i n d u l g e s in m a l p r a c t i c e .
The a p p e l l a n t
concedes that these three methods "have the b l e s s i n g of the American Medical A s s o c i a t i o n " but he contends that there i s no sure
cure f o r the ailment and "no unanimity of o p i n i o n as to which o f
s a i d procedures should be employed on [ s i c ] a p a r t i c u l a r c a s e . "
This Court w i l l take j u d i c i a l n o t i c e of the supreme e f f o r t
b e i n g made by the members o f the medical p r o f e s s i o n and by the
c i t i z e n r y as w e l l to conquer the great human . k i l l e r , c a n c e r .
The f i g h t i s u n r e l e n t i n g . . . The r e a s o n , of c o u r s e , f o r the
i n t e n s i v e campaign is that the d i s e a s e i s out of hand because
the remedy i s so f a r unfound . . .
We do not propose to i n d i c a t e what from the record in
this case would appear to be the proper treatment i n a given
case . . . But we do have a conviction that the h e r o i c e f f o r t
being made by members of the medical p r o f e s s i o n and o t h e r
s c i e n t i s t s only emphasizes that an enemy i s so f a r b e i n g
fought i n the dark and that one man should not be condemned
from the f a c t alone that he chooses a weapon that another may
"5T
c o n s i d e r a reed
Moreover,
the court concluded that no malpractice
-12-
can be found s o l e l y on
grounds of e x p e r i m e n t a t i o n
for possible
is no c e r t a i n
.
cure and
.
.
cures when,
the p h y s i c i a n
did not
i n a given
indulge
case,
"there
in quackery
by
62
r e p r e s e n t i n g he had one
.
.
.".
I n formulating
this p o s i t i o n
on e x p e r i -
mentation,
the B a l d o r court departed from almost
a l l previous
cases
and
determined
that e x p e r i m e n t a t i o n has a l e g i t i m a t e
s c i e n t i f i c purpose
and
is
to be e n c o u r a g e d , at least
63
means o f
there are no
effective
treatment.
While Baldor
other
in cases i n which
cases have
focused on the a p p r o p r i a t e n e s s
centered
their discussions
of
the
experimentation,
on the n e c e s s i t y o f
disclosing
the known r i s k s of experimental p r o c e d u r e s .
For example, i n F i o r e n t i n o v .
64
Wenger a New York court found that a p h y s i c i a n ' s use of a " n o v e l and unortho65
dox" procedure for curing s c o l i o s i s (curvature of the s p i n e ) must be accompanied
by a d i s c l o s u r e to t h e [ p a t i e n t ' s ] p a r e n t s concerning the risks i n v o l v e d in
66
use.
I n a d d i t i o n , the court determined that the h o s p i t a l was a l s o l i a b l e
for f a i l i n g "to
before
ascertain
permitting
It
is
that the p h y s i c i a n had made such a
67
the o p e r a t i o n to take p l a c e . "
interesting
to note
procedure as " e x p e r i m e n t a l "
that the F i o r e n t i n o
even
its
disclosure
court viewed the
though i t had been used t h i r t y - f i v e
scoliosis
times
68
over a five-year p e r i o d .
procedures
New York
first
to be " t h e r a p e u t i c "
court i n
Fiorentino,
is s i g n i f i c a n t
courts
This
a Texas
court
the world
is
therapeutic
involved,
found much more n o v e l
the approach taken by
69
in Karp v .
Cooley,
held
a human being was
renown
Dr.
Denton
the
that
the
exclusively
Cooley,
the growing trend among American
to view consent as much more important
the medical procedure
purpose
illustrates
have
Unlike
heart i n t o
caseinvolving
because i t
however,
in nature.
i m p l a n t a t i o n o f an a r t i f i c i a l
"therapeutic".
of
Other c o u r t s ,
especially
and the p a t i e n t ' s
than
in
the experimental
cases i n which " t h e
choices of s u r v i v a l w i t h o u t
character
primary
the
114
e x p e r i m e n t a l p r o c e d u r e are m i n i m a l . "
artificial
heart i n
s u r v i v e d f o r almost
the chest of h i s p a t i e n t ,
three days,
malpractice,
to o b t a i n
Dr.
Cooley implanted
Haskel K a r p .
Mr.
but d i e d when the a r t i f i c i a l
replaced by a human donor h e a r t .
along w i t h D r .
I n Karp,
The p a t i e n t ' s w i f e sued D r .
Domingo L i o t t o who developed
a l l e g i n g among o t h e r
things,
71
informed c o n s e n t .
The t r i a l
the a r t i f i c i a l
directed
Karp
h e a r t was
Cooley,
heart,
that the doctors had
court
an
a verdict
for
failed
in
favor
72
of
the doctors and the d e c i s i o n was l a t e r
In a d d r e s s i n g
the i s s u e of informed consent,
w r i t t e n consent forms
wife witnessed
a f f i r m e d by the F i f t h
the court looked
73
that Karp had executed p r i o r to s u r g e r y .
the f o l l o w i n g
consent
Circuit.
to
the
Karp's
form which Karp s i g n e d b e f o r e
the
operation.
I , H a s k e l l Karp request and a u t h o r i z e D r . Denton Cooley
and such o t h e r surgeons as he may d e s i g n a t e , to perform upon
me, i n S t . L u k e ' s E p i s c o p a l H o s p i t a l of Houston, T e x a s , c a r d i a c
surgery f o r advanced c a r d i a c decondensation and myocardial
i n s u f f i c i e n c y as a r e s u l t of numerous coronary o c c l u s i o n s .
The r i s k o f the surgery has been e x p l a i n e d to me.
I n the e v e n t
c a r d i a c f u n c t i o n cannot be r e s t o r e d by e x c i s i o n o f d e s t r o y e d
h e a r t muscle and p l a s t i c r e c o n s t r u c t i o n o f the v e n t r i c l e and
death seems to be imminent, I a u t h o r i z e D r . Cooley and h i s
s t a f f to remove my d i s e a s e d h e a r t and i n s e r t a mechanical
cardiac substitute.
I understand that t h i s mechanical d e v i c e
w i l l not be permanent and u l t i m a t e l y w i l l require replacement
by a heart t r a n s p l a n t .
I r e a l i z e that this device has been
tested in the laboratory but has not been used to s u s t a i n a
human being and that no a s s u r a n c e of success can be made.
I expect the surgeons to e x e r c i s e every e f f o r t to p r e s e r v e
my l i f e through any of these means.
No assurance has been
made by anyone as to the r e s u l t s that may be o b t a i n e d .
I understand that the o p e r a t i n g surgeon w i l l be o c c u p i e d
s o l e l y w i t h the surgery and that the a d m i n i s t r a t i o n of the
a n e s t h e t i c ( s ) i s an independent f u n c t i o n .
I hereby request
and a u t h o r i z e D r . Arthur S . K e a t s , or others he may design a t e , to a d m i n i s t e r such a n e s t h e t i c s as he or they may deem
advisable.
I hereby consent to the photographing of the o p e r a t i o n
to be performed, i n c l u d i n g a p p r o p r i a t e p o r t i o n s of my b o d y ,
f o r m e d i c a l , s c i e n t i f i c , and e d u c a t i o n a l p u r p o s e s . 74
While
this
form contains s p e c i f i c
references
•14-
to the s u r g i c a l
procedures
114
involved,
First,
it
fails
to meet the i d e a l
the form contains medical
requirements
i n a number o f w a y s .
terms which are not d e f i n e d in lay
language.
Second,
the form d e s c r i b e s only i n g e n e r a l terms the p o s s i b l e outcomes of
76
the p r o c e d u r e .
T h i r d , the consent form p r o v i d e s a much b r o a d e r a n e s t h e t i c
77
a u t h o r i z a t i o n than was necessary f o r the s u r g e r y .
F i n a l l y , the form
neglects
to e x p l a i n
clearly
heart
and the p r o b a b i l i t y
these
defects
d i d not
in
the experimental
c h a r a c t e r of the a r t i f i c i a l
78
functioning successfully.
Notwithstanding
of i t s
the consent
form and K a r p ' s w i f e ' s
understand how experimental
the a r t i f i c i a l
contentions
that
she
heart procedure was
and
79
that her husband had not read the document b e f o r e s i g n i n g i t ,
Circuit
summarily
t a i n s no evidence
. . .
in
this
traditional
d i s m i s s e d the arguments,
that Mr. K a r p ' s
context an a c t i o n
for e x p e r i m e n t a t i o n
80
court's
approach
of
issues
such as
a formal
heart
the nature of
81
review p r o c e s s .
Fifth
record
con-
than t h e r a p e u t i c
and
must be measured by
standards."
to the experimentation
c r i t i c i z e d by s c h o l a r s who argue
key
treatment was o t h e r
malpractice e v i d e n t i a r y
The Karp
s t a t i n g that " t h e
the
that the a p p e l l a t e
i s s u e has
court
been
failed
to
address
the experimental procedure and the
Commentators p o i n t out
that
surgery was a " f i r s t - o f - i t s - k i n d human experiment
the
lack
artificial
done w i t h
debatable
82
p r e t e s t i n g on a n i m a l s . "
Moreover, there was no formal p e e r review of protocol
83
f o r the novel e x p e r i m e n t a t i o n .
C r i t i c s argue that the Karp c o u r t ' s c o n c l u s i o n
that
the procedure was
untenable.
conclusion
evidence
consent],
t h e r a p e u t i c and not p r i m a r i l y
One s c h o l a r d e s c r i b e d the c o u r t ' s
can only mean that
at the
trial
this
stating:
the judge was not p r e s e n t e d with
l e v e l on this
issue
o r viewed the magnitude o f
Accordingly,
action,
an e x p e r i m e n t ,
c r i t i c maintains
the
is
"The
sufficient
[human e x p e r i m e n t a t i o n I and
risks
involved
that had the court
U i u M o
•15-
as
court's
informed
84
irrelevant."
considered
the
a r t i f i c i a l heart o p e r a t i o n e x p e r i m e n t a l ,
Health,
Education,
at
time,
that
with
and W e l f a r e
complete
the experimental
guidelines
Shortly
surgery.
peutic
f o r consent
I n any c a s e ,
forms,
federal
which
and r i s k s
required,
associated
i t seems c l e a r that
had the issue been viewed as
Karp
experi-
therapy.
a f t e r the Karp o p i n i o n was
Lung I n s t i t u t e
could have a p p l i e d
disclosure of possible benefits
85
would have been r e s o l v e d d i f f e r e n t l y
mentation i n s t e a d of
it
delivered,
the N a t i o n a l Heart
m o d i f i e d i t s previous p o s i t i o n on human t e s t i n g of
devices by i s s u i n g
the f o l l o w i n g supplemental
and
thera-
criteria:
The device i s to be used only i n a s i t u a t i o n in which i t o f f e r s
at l e a s t as l i k e l y b e n e f i t as any known accepted technique or
any experimental technique which i s a v a i l a b l e for c l i n i c a l t r i a l
in the same s e t t i n g by the same group.
There must be experimental evidence from laboratory animal
s t u d i e s of b e n e f i c i a l e f f e c t .
D e f i n i t i v e c r i t e r i a f o r p a t i e n t s e l e c t i o n must be i n c l u d e d
in the i n v e s t i g a t i o n p r o t o c o l .
The approval of l o c a l i n s t i t u t i o n a l research commit tees and
other appropriate committees and conformity to the I n s t i t u t i o n a l
Guide to DHEW [Department of H e a l t h , E d u c a t i o n , and W e l f a r e ]
P o l i c y on P r o t e c t i o n of Human S u b j e c t s i s r e q u i r e d .
P r i o r to the c l i n i c a l u s e , the complete research p r o t o c o l
must be approved by NHL I ( N a t i o n a l Heart and Lung I n s t i t u t e ] . ® * *
Failure
to follow
for any i n d i v i d u a l
and whose funding
these
guidelines
could
result
i n a malpractice
finding
or o r g a n i z a t i o n a l
body doing
research on human
comes from H e a l t h ,
Education,
and W e l f a r e
beings
or whose
87
hospital
requires
Unlike K a r p ,
tion
institutional
the vast majority
of cases
i n v o l v i n g novel
and implant i n s e r t i o n s were never l i t i g a t e d .
patient
r e c e i v e d much l e s s
than d i d H a s k e l K a r p .
heart
Dr.
review b e f o r e e x p e r i m e n t a t i o n
transplant,
For i n s t a n c e ,
L o u i s Washkansky,
C h r i s t i a n Barnhard,
o f e i g h t y percent
information
rather
to b e l i e v e
about
the
the s u r g i c a l procedures
was i n t e n t i o n a l l y
the
first
used
human
misled by h i s
the o p e r a t i o n had a success
than being informed
-16-
transplanta-
I n many c a s e s ,
the r e c e p i e n t of
that
on humans.
surgeon,
probability
that he had an e i g h t y percent
chance
of l i v i n g
his
through
actions
in
the o p e r a t i o n .
failing
to d i s c l o s e
o p e r a t i o n by e x p l a i n i n g
odds when
what
that
to s u r v i v e
to b e l i e v e
later denied
artificial
valve.
type of valve
when l e a v i n g
Perhaps
the
signed
f o r the p a t i e n t
is
in his
justify
the
transplant
to accept
favor i n s t e a d
the
of
failure
to inform i n v o l v e d
was not
informed about
Moreover,
first
heart v a l v e .
The
the implant b e f o r e
the procedure was a repeat of an
received.
the
her physician,
surgery
operation
Dr.
Dwight
that she could h e a r the c l i c k i n g sound made by
Mrs.
her
Richardson n e v e r r e c e i v e d any information o r saw
implanted u n t i l she was
90
confronted by newspaper
reporters
hospital.
the most a p p a l l i n g
inform h i s p a t i e n t of
operation
case of
that
that she had p r e v i o u s l y
the
is easier
the i m p l a n t a t i o n of an a r t i f i c i a l
Mary R i c h a r d s o n ,
but was l e d
Harkin,
r i s k s e n t a i l e d in
to
are.
An even more shocking
patient,
it
the
they are p r e s e n t e d as b e i n g h e a v i l y
89
they a c t u a l l y
patient
Barnhard l a t e r attempted
case of a p h y s i c i a n
the medical procedures
the f i r s t heart
transplant.
the f o l l o w i n g statement of
failing
to
adequately
contemplated in a proposed
The s i s t e r of the
recipient
consent:
1 hereby give f u l l p e r m i s s i o n for l e f t l e g amputation and heart
surgery on Boyd Rush.
I understand that any clots p r e s e n t w i l l
be removed from the h e a r t to stop them from going to s t i l l more
a r t e r i e s of h i s b o d y .
I f u r t h e r understand that h i s h e a r t i s
in extremely poor c o n d i t i o n .
I f for any u n a n t i c i p a t e d reason
the h e a r t should f a i l completely during e i t h e r o p e r a t i o n and
i t s h o u l d be impossible to s t a r t i t , I agree to the i n s e r t i o n
of a s u i t a b l e heart t r a n s p l a n t i f such should be a v a i l a b l e at
the time.
I further understand that hundreds of heart transp l a n t s have been performed i n l a b o r a t o r i e s throughout the w o r l d
but that any heart t r a n s p l a n t would represent the i n i t i a l transp l a n t i n man. ^
During
the o p e r a t i o n ,
human donor was
surgery
a heart
available.
using a large
t r a n s p l a n t was deemed n e c e s s a r y ,
Dr.
James
but no
D . Hardy performed the t r a n s p l a n t
92
chimpanzee h e a r t .
The operation proved u n s u c c e s s f u l
and many h i s t o r i a n s
medical
believe
that
the
furor that i t evoked in
community i n s u r e d that the f i r s t human heart
93
be performed
in
this
Controversy
cial hearts
problems
s t i l l surrounds heart
of o b t a i n i n g
devices.
adequate
experimental procedures,
Association published
device
American
t r a n s p l a n t w o u l d not
country.
and a s s i s t
cular assist
the
transplants
I n an e f f o r t
informed
to m i t i g a t e
Because i n many s i t u a t i o n s
difficult
of the American
f o r the c l i n i c a l
(LVAD) , a d e v i c e
the
use of
and h i s
the l e f t
family have l o s t
for
Heart
used in some forms o f h e a r t
the p a t i e n t
artifi-
consent from a dying p a t i e n t
the Committee on E t h i c s
94
guidelines
and the use o f
ventrisurgery.
the
ability
to give meaningful
in
the
consent, the g u i d e l i n e s suggest the use of a t h i r d party
95
consent p r o c e d u r e .
The t h i r d p a r t y ' s f u n c t i o n is to mediate the
consent process
and
and to reassure and comfort both the p a t i e n t , h i s f a m i l y ,
96
the medical p e r s o n n e l .
I n a d d i t i o n , the committee's g u i d e l i n e s
expressly
alone i s
reject
the argument
sufficient
L i k e most
on the q u a l i t y
transplant
court o p i n i o n s
follow
that
concentrate
nontherapeutic
i n v o l v i n g minors,
o f Saskatchewan,
In
patient
more on consent
cases
provided.
focus
Except
experimentation
that American
by one Canadian
agency.
their
for
to be
attention
the
told that he could earn
p f
-18-
fifty
1
kidney
appellate
this
country.
court and one New
c a s e , Halushka v .
the s u b j e c t of
the
courts would probably
appellate
the Canadian
in
than
University
a student was employed by the U n i v e r s i t y H o s p i t a l
Saskachewan
The s t u d e n t was
agree
taken
the
there are no post-Nuremberg
concerning n o n t h e r a p e u t i c
York a d m i n i s t r a t i v e
97
of
cases
academicians
condition of
the use of the LVAD.
contemplated,
the approach
University
the terminal
and e x t e n t of i n f o r m a t i o n
cases
Nevertheless,
to j u s t i f y
therapeutic
type of procedure
that
a test i n v o l v i n g
at
a new
d o l l a r s by p a r t i c i p a t i n g
the
drug.
in
the experiment which was d e s c r i b e d by h o s p i t a l p e r s o n n e l as b e i n g " p e r f e c t l y
98
safe".
He was also t o l d that the experiment r e q u i r e d that an i n c i s i o n
be made i n h i s arm f o r the i n s e r t i o n of a catheter i n t o h i s
consent
form,
s i g n e d by the s t u d e n t ,
vein.
The
stated:
. . .
I have v o l u n t e e r e d f o r tests upon my person f o r the purpose
of study of Heart & Blood C i r c u l a t i o n Response under General
Anesthesia.
The tests to be undertaken in connection w i t h t h i s study
have been e x p l a i n e d to me and I understand f u l l y what is proposed
to be done.
I agree of my own free w i l l to submit to these t e s t s ,
and i n c o n s i d e r a t i o n of the remuneration h e r e a f t e r set f o r t h , I
do r e l e a s e the c h i e f i n v e s t i g a t o r s .
D r . G.M. Wyant and J . E . Merriman, t h e i r a s s o c i a t e s , technic i a n s , and each t h e r e o f , o t h e r p e r s o n n e l i n v o l v e d i n these s t u d i e s ,
the U n i v e r s i t y H o s p i t a l B o a r d , and the U n i v e r s i t y o f Saskatchewan
are a b s o l v e d from a l l r e s p o n s i b i l i t y and claims w h a t s o e v e r , f o r
any untoward e f f e c t s or a c c i d e n t s due to or a r i s i n g out o f s a i d
tests, either directly or i n d i r e c t l y .
I understand that I s h a l l r e c e i v e a remuneration of $ 5 0 . 0 0
jt
99
for one test . . .
The s u r g i c a l
arm and
where
procedure was performed by i n s e r t i n g
threading i t
through h i s heart
it was p o s i t i o n e d .
stopped.
In
response,
charged
for an a d d i t i o n a l
for his ordeal.
The e x p e r i m e n t e r s '
the p a t i e n t ' s
remained unconscious
ten days.
the experimenters
the student asked i f
fifty
Shortly
court judge
same
that
the duty of
duty a s s o c i a t e d w i t h
experimenters
response was
before
that he
four days
he was
argued
that
-19-
and
dis-
dollars.
Not
receive
form.
and was
The jury had been informed by the
disclosure
heart
could get more
the experimenters
relationship.
awarded
trial
under such circumstances was
the doctor-patient
unsuccessfully
unexpectedly
d o l l a r s was a l l he was to
The student brought an a c t i o n a g a i n s t
verdict of $ 2 2 , 5 0 0 . 0 0 .
artery
heart
for
gave him f i f t y
money i f h i s mother and s i s t e r would s i g n a r e l e a s e
a jury
the pulmonary
his
cut open h i s chest and restored h i s
The p a t i e n t
from the h o s p i t a l ,
surprisingly,
thereafter,
the surgeons
b e a t by manual massage.
was h o s p i t a l i z e d
Shortly
and out i n t o
a catheter into
the
On a p p e a l ,
the student had consented
to
the
the
procedure.
holding
than"
The a p p e l l a t e
court r e j e c t e d
that the duty owed was " a t
the d e f e n d a n t ' s
l e a s t as great
the duty d e s c r i b e d by the t r i a l
court.
as,
contention,
i f not
The court
greater
stated:
There can be no e x c e p t i o n s to the o r d i n a r y requirements of
d i s c l o s u r e in the case of research as there may w e l l be in
o r d i n a r y medical p r a c t i c e .
The r e s e a r c h e r does not have to
balance the probable e f f e c t of lack of treatment a g a i n s t
the r i s k i n v o l v e d in the treatment i t s e l f .
The example of
risks b e i n g properly h i d d e n from a p a t i e n t when it i s important that he should not worry can have no a p p l i c a t i o n in
the f i e l d of r e s e a r c h .
The s u b j e c t of medical experimentation is e n t i t l e d to a f u l l and frank d i s c l o s u r e of f a c t s ,
p r o b a b i l i t i e s and o p i n i o n s which a reasonable man might be
expected to c o n s i d e r b e f o r e g i v i n g h i s consent.
The New York a d m i n i s t r a t i v e
case i n v o l v i n g n o n t h e r a p e u t i c
experi-
101
mentation,
a result
of
directors
board.
known as the J e w i s h Chronic D i s e a s e H o s p i t a l
disciplinary
approval,
that
case,
chronically
ill
cancer c e l l s "
o r that
under the s k i n of
and d e b i l a t e d p a t i e n t s
The p a t i e n t s were not informed
that
the procedure was designed
reject
foreign
cells.
immune
reaction,
was
at
the B r o o k l y n ,
the l i v e
medicine's
twenty-two
New York
the p a t i e n t s '
the e x p e r i m e n t ,
unrelated
licensing
hospital.
cancer c e l l s were b e i n g
to measure
The purpose of
totally
the d i r e c t o r of
as
b o a r d of
b e f o r e New Y o r k ' s s t a t e
three d o c t o r s , with
injected " l i v e
arose
p r o c e e d i n g s brought by the h o s p i t a l ' s
against physician-researchers
In
case,
ability
to study
to the i n d i v i d u a l s '
the
normal
used
to
patients'
thera-
102
peutic
treatment.
The cancer experiment brought
hospital's
doctors
and board of
surrounding
and ultimately
directors
the e x p e r i m e n t a l
Regents
l e d the h o s p i t a l ' s
study prompted
to revoke
the state
the medical
00313
-20-
the Attorney
licensing
l i c e n s e s of
among the
grievance
103
to make a formal i n v e s t i g a t i o n .
New York to b r i n g a c t i o n s b e f o r e
Board of
about a h e a t e d controversy
The
committee
publicity
General
authority
two of the
of
and the
doctors
104
involved.
Pursuant
to the a u t h o r i t y
board imposed s a n c t i o n s
stayed
including
a one y e a r s u s p e n s i o n .
the e x e c u t i o n of the s u s p e n s i o n
tion f o r one
obligations
the
The board
later
and p l a c e d the two doctors on proba-
the q u e s t i o n s
that various p a r t i c i p a n t s
toward one a n o t h e r .
Committee emphasized
In addition,
experiment
law,
year.
During the proceedings
have
given i t under New York
it
The o p i n i o n
the n e c e s s i t y
in
reason,
issue
concerned the d u t i e s
the s c i e n t i f i c
investigatory
and
process
i s s u e d by the Board of Regents
for f u l l
recognized a p a t i e n t ' s
f o r any
at
intelligent
d i s c l o s u r e of a l l
right " t o
refuse
or o t h e r w i s e ,
Discipline
105
material f a c t s .
to p a r t i c i p a t e
well-informed
i n an
or
106
prej u d i c e d . "
These
two c a s e s ,
Halushka and the J e w i s h Chornic Disease H o s p i t a l
s t a n d f o r the p r o p o s i t i o n
patient.
The
situations
that a normal volunteer can n e v e r be c o n s i d e r e d
usual doctor-patient
and any e x c e p t i o n s
relationship
to the rule
does not e x i s t
favoring
full
in
disclosure
apply may not be invoked i n an experimenter-subject
10 7
ship.
words,
doctors p a r t i c i p a t i n g
material
there i s no " t h e r a p e u t i c p r i v i l e g e "
in n o n t h e r a p e u t i c e x p e r i m e n t a t i o n .
to the s u b j e c t ' s
procedures
must be
decision
fully explained
A.
Failure
has
Battery
to p a r t i c i p a t e
in
the
and p r e s e n t e d to the
relation-
to
information
experimental
subject.
Actions
to o b t a i n proper consent i n a doctor-patient
traditionally
that
available
All
a
such
might o t h e r w i s e
In o t h e r
case,
been viewed as a battery
inasmuch
as
relationship
the d o c t o r ' s
actions
108
c o n s t i t u t e "unconsented-to
in a battery
case w i l l
tion i n v a l i d a t e d
privilege
touching".
contend that
any g e n e r a l i z e d
to touch
the p a t i e n t ' s
Generally,
the d o c t o r ' s
the
patient-complaintant
failure
consent and accordingly
body.
Moreover,
AIVO^ M
t U j . ^ l
-21-
there
to d i s c l o s e
terminated
is no need
informathe
doctor's
for expert
testimony inasmuch as the p h y s i c i a n ' s
109
consent i s i n v a l i d l y o b t a i n e d .
Cases most o f t e n l i t i g a t e d
who has operated on the
consent and ( 2 )
wrong
privilege
to touch ends when
involve
two b a s i c s i t u a t i o n s :
part of
the body and thus
a p h y s i c i a n who has not adequately
(1)
the
patient's
a physician
acted w i t h o u t
advised
the p a t i e n t
of
110
the p o t e n t i a l
consequences of
of situations
can prove
patients
a given
form of
may be awarded
that he d i d not consent
where m a t e r i a l information
treatment.
damages
from a doctor i f
to the procedures performed.
has been w i t h h e l d ,
courts g e n e r a l l y
consent i n e f f e c t i v e .
The r a t i o n a l e b e h i n d such h o l d i n g s
principle
human b e i n g of
that " e v e r y
the o p t i o n s a v a i l a b l e
and the
B.
Notwithstanding
theory,
failure
to make adequate
as a breach of
patient
there
is
more d i f f i c u l t
d i d not consent
addition,
a modern
body o f
disclosures
duty
rather
to maintain because
to the p r o c e d u r e ,
but
thus w o u l d not hhve been i n j u r e d .
also
basic
a right
court,
rely on
and r i s k s
thereby
a
the
physician's
to the p a t i e n t
requiring
A negligence action
that had the p h y s i c i a n
the
is
that he
that he was i n j u r e d by i t .
In
complied w i t h
consented to the
procedure
Courts seem to p r e f e r t h e n e g l i g e n c e
for a number of
for
that
the p a t i e n t must prove not only
the p a t i e n t would not have
113
act i n good f a i t h
the
to one
case law which views
than b a t t e y .
and
generally
consent
to the p a t i e n t ,
duty o f d i s c l o s u r e ,
theory
find
rests on the
According
of a l t e r n a t i v e s
the p a t i e n t must demonstrate
to the battery
cases
Actions
his
theory
In
to e v a l u a t e knowledgeably
112
attendant upon e a c h . "
Negligence
to sue i n n e g l i g e n c e
patient
an opportunity
risks
the p h y s i c i a n ' s
the
111
the many cases on informed
battery
types
adult years and sound mind has
to determine what s h a l l be done w i t h h i s own body."
the concept o f consent " e n t a i l s
I n both
reasons.
First,
physicians
the b e n e f i t of the p a t i e n t and do not
intend
114
to engage in unlawful
social
not
reasons.
the r e s u l t s of
fall within
Second,
i n terms o f a s s a u l t
the p a t i e n t ' s
complaint
the treatment or procedure were
anti-
and b a t t e r y
is based on the
fact
u n a n t i c i p a t e d which
does
the e s t a b l i s h e d concept of " c o n t a c t "
the doctor u s u a l l y a d m i n i s t e r s
failure
T h e i r actions are not a s s o c i a t e d w i t h
conduct and are only c h a r a c t e r i z e d
for technical
that
touching.
to make adequate
or " t o u c h i n g " .
In f a c t ,
115
impeccably.
Third, a physician's
the treatment
disclosures
to a p a t i e n t
is
u s u a l l y not an
intentional
116
act
falling within
intentional
fall
outside
the t r a d i d i o n a l
definition
of an i n t e n t i o a n l
tort.
Fourth,
torts such as b a t t e r y may c o n s t i t u t e
the p h y s i c i a n ' s
malpractice
a criminal act and t h e r e f o r e
117
insurance coverage.
Finally, punitive
118
damages should not be a v a i l a b l e
in failure
counted the l a s t
claiming
three
reasons,
to warn c a s e s .
Critics
have
that they are e i t h e r wrong or
disirrele-
119
vant.
Nevertheless,
patient
in the
the f a c t remains
therapeutic
n o n d i s c l o s u r e of
setting
risks because o f
to prove a l l of
consent
is
the s t r i n g e n t
suit.
the t h e r a p e u t i c
a c t u a l l y occurred
a doctor
of proof
even assuming
for
in
the p a t i e n t
the doctor in an
defenses,
for a
is
informed
the most important o f
which
privilege.
One major d i s t i n c t i o n
the former c a s e ,
requirements
Furthermore,
case has a number of a f f i r m a t i v e
difficult
in a s u i t a g a i n s t
the elements o f n e g l i g e n c e ,
(1.)
in
to p r e v a i l
is extremely
120
a n e g l i g e n c e or m a l p r a c t i c e
able
that i t
The P h y s i c i a n ' s
between
a patient
Duty
the n e g l i g e n c e
and b a t t e r y
actions
may sue only i f one of the u n d i s c l o s e d
and caused him p h y s i c a l or mental harm whereas
l a t t e r case the p a t i e n t
could sue s u c c e s s f u l l y
would not have consented
by merely showing
to the treatment had he been aware of
in
is
that
risks
the
that he
the
risks
that
121
the
physicain
f a i l e d to d i s c l o s e .
physician
in a n e g l i g e n c e
action
is
to accept
the medical p r o f e s s i o n ' s
Another
factor
the trend of
definition
of
that is
the majority o f
the
U0 j •>>
•23-
favorable
scope of a
to
the
courts
physician's
duty.
A doctor is bound to d i s c l o s e only
o f his p r o f e s s i o n would have d i s c l o s e d
standard medical p r a c t i c e
an e x p e r t
This
witness
/
is being a b a n d o n e d
under s i m i l a r
as the c r i t e r i a ,
to t e s t i f y
traditional
that information
that o t h e r members
circumstances.
the p l a i n t i f f
is
required
Using
to
call
122
the p h y s i c i a n ' s d u t y .
on the i s s u e o f
approach of o b s e r v i n g s t a n d a r d medical p r a c t i c e ,
i n a number of j u r i s d i c t i o n s
however,
and replaced by a growing
/
trend that e v a l u a t e s
know p a r t i c u l a r
the p h y s i c i a n ' s
information
duty a c c o r d i n g
regarding his
case.
to the p a t i e n t ' s
need
to
This modern approach was
123
promulgated by the Rhode I s l a n d Supreme Court i n Wilkenson v .
court
Vesey.
The
commented:
Tne p a t i e n t ' s right to make up h i s mind should not be d e l e g a t e d
to a l o c a l medical group - many o f whom have no i d e a as to h i s
informational needs.
The doctor-patient r e l a t i o n s h i p i s a oneon-one a f f a i r .
What is reasonable d i s c l o s u r e in one i n s t a n c e
may not be reasonable i n a n o t h e r . 1 2 4
The C i r c u i t Court o f
the D i s t r i c t of Columbia adopted a s i m i l a r view
in
125
Canterbury
v.
Spence when i t observed
that " [ r j e s p e c t
f o r the p a t i e n t ' s
o f s e l f - d e t e r m i n a t i o n on p a r t i c u l a r
therapy
demands a s t a n d a r d set by
rather
may or may not impose upon
right
law
126
than one on which p h y s i c i a n s
According
is
required
to
the C a l i f o r n i a Supreme Court i n Cobbs v .
to make f i v e
the proposed medical
or p r o c e d u r e ;
procedure;
disclosures
(4)
(3)
disclosures
i n lay l a n g u a g e :
treatment or p r o c e d u r e ;
inherent
anticipated
risks
(2)
(1)
themselves."
12 7
G r a n t , the p h y s i c i a n
a description
alternatives
to such
treatment
a s s o c i a t e d w i t h the proposed treatment
recuperation problems;
and
(5)
any
that a p h y s i c i a n
or
additional
128
that o t h e r doctors would make i n s i m i l a r circumstances.
Cobbs court also p o i n t e d out
of
The
need make no d i s c l o s u r e s
at
129
all
for common treatments
Cases such as
these
and procedures
that
follow
such as drawing b l o o d .
the modern approach g e n e r a l l y
that
hold
a p h y s i c i a n ' s duty is based on the f i d u c i a r y q u a l i t i e s o f the doctor-patient
130
relationsnip.
The trust and dependence i n h e r e n t in any such r e l a t i o n s h i p
A A O I V !
OOoW
-24-
creates
an a f f i r m a t i v e
p r i o r to commencing
duty i n
a breach of
d i f f i c u l t questions
the
with
revolving around the requirement
two approaches
requirement.
treatment
disclosure,
According
that p r a c t i t i o n e r s
to the battery
Based on t h i s p r i n c i p l e ,
f o r himself
f o r any reason,
generally
theory
an i n d i v i d u a l
regardless
the jury i s p r e s e n t e d w i t h a q u e s t i o n b a s e d on
toward treatment,
namely " w o u l d this
relevant
to t h i s
determination include
and n i s p e r s o n a l
The second approach,
patient's
ideals
and
resulting
invoke
approach,
the
right of
may r e f u s e
disclosed
doctrine
patient's
theory
subjective
the
to
attitude
the
risKs?".
the i n d i v i d u a l ' s
his business schedule,
131
deal
self-
Under the b a t t e r y
the p a t i e n t ' s
to
medical
i n j u r e d p a t i e n t have consented
l o s i n g a p a r t i c u l a r body p a r t or o r g a n ,
beliefs,
the
of how unsound the
treatment o r procedure had the p h y s i c i a n properly
prove
the p a t i e n t would not
reasoning may seem to the doctor or the community.
Criteria
dis-
that the p a t i e n t
o f informed consent i s grounded p r i m a r i l y on the p a t i e n t ' s
determination.
in
r a i s e a number of
to the procedure and thus would not have a c q u i r e d
There are
this
adopted
duty occurs when the r e q u i r e d
therapeutic privilege
that had the doctor made a p a r t i c u l a r
injury.
rule i s
disclosures
made.
The c a u s a t i o n and defense of
"have consented
to make a p p r o p r i a t e
treatment and r e g a r d l e s s whichever
a particular jurisdiction,
closure i s not
the p h y s i c i a n
f e a r of
religious
attitudes.
which d e f i n e s
the p h y s i c i a n ' s
need to know r e l e v a n t i n f o r m a t i o n
duty i n
concerning h i s
terms o f the
132
treatment, rejects
the " s e l f - d e t e r m i n a t i o n "
resolve h y p o t h e t i c a l
seriously
questioned a j u r y ' s
p a t i e n t who
done i f
.
r a t i o n a l e on c a u s a t i o n because i t f o r c e s a j u r y to
133
questions.
Courts adopting the second approach have
.
ability
"to judge
the veracity o f
an
injurred
t e s t i f i e s (based on ' 2 0 - 2 0 h i n d s i g h t ' ) as to what he would have
134
.".
As a r e s u l t , t h i s second school of thought on informed
consent has adopted an o b j e c t i v e
r a t h e r than the p a t i e n t ' s
standard
autonomy.
that p r o t e c t s
Thus,
must determine what a " r e a s o n a b l e p e r s o n "
under t h i s
in
the
physician
approach,
the p a t i e n t ' s
the
jury
position
would have decided and not what the i n d i v i d u a l p a t i e n t would have
135
d e c i d e d had he been given the p r o p e r i n f o r m a t i o n .
(2.)
While
prevail
these c a u s a t i o n
in
with a d d i t i o n a l
affirmative
where
defenses.
doctor's
It
consent
i s now w e l l
p r o f e s s i o n a l judgment
Authorities
cases,
settled
that
physicians
courts have
provided
(1)
in an emergency;
it
remote;
is
and
(3)
(4)
(2)
in
need
cases
i n cases where
the
in cases where i n
not in the p a t i e n t ' s
concerning his treatment
argue that o f
several
that no d i s c l o s u r e s
to be informed;
i s simple and the danger
facts
insure
guarantees o f success by r e c o g n i z i n g
does not want
to know the r e l e v a n t
Defenses
generally
the f o l l o w i n g s i t u a t i o n s :
the p a t i e n t
treatment
theories
the majority of informed
physicians
be made i n
Affirmative
best
the
interest
136
privilege).
(therapeutic
these four commonly s t a t e d d e f e n s e s ,
only
137
the
t h i r d should be permitted i n
defense,
applicable
in a n o n t h e r a p e u t i c
prevent
the experimental
only i n emergency s i t u a t i o n s ,
experimental
the second d e f e n s e
setting.
setting.
to the
that
the
to v o l u n t e e r
fourth defense has great p o t e n t i a l
s h o u l d never be permitted in
is a primary
therapeutic
Basically,
disclosure
for e x p e r i m e n t s .
experiemental
the
procedures
Commentators
for abuse and argue
the experimental
139
setting,
invoked
considerations
s e t t i n g because s u b j e c t s who have not been informed about
138
s h o u l d not be allowed
first
should never be
Public policy
from b e i n g a p p l i c a b l e
The
note
that
even where
it
there
purpose.
the doctrine of
therapeutic privilege
of r i s k s poses such a " t h r e a t of
A A 0 1
detriment"
A
w - o . x j
-26-
states
that when
to the
individual
that such d i s c l o s u r e becomes
unfeasible
the p h y s i c i a n need not f o l l o w ordinary
usually
becomes a p p l i c a b l e when
from a medical p o i n t o f
140
disclosure procedures.
the p a t i e n t
is
d e c i s i o n such as i n cases of extreme i l l n e s s
During such p e r i o d s ,
a patient's
inability
unable
to make r a t i o n a l
I n Cobbs,
the
"when a doctor can prove by a preponderance
f a c t s which would demonstrate
have so s e r i o u s l y
to d i s p a s s i o n a t e l y weigh
142
treatment."
Commentators argue
the
that the
could
to the
play
the evidence he r e l i e d
refusing
to undergo
therapeutic privilege
upon
would
that the p a t i e n t would not have
risks of
141
patient.
comes i n t o
to a reasonable man the d i s c l o s u r e
upset the p a t i e n t
able
of
upset.
choices
damage
therapeutic privilege
doctrine
rational
or severe emotional
or cause p y s c h o l o g i c a l
that
The
to form a
complicate o r h i n d e r treatment,
the court s t a t e d
view,
the
been
recommended
should not be
allowed
143
i n any e x p e r i m e n t a t i o n ,
experimental
t h e r a p e u t i c or n o n t h e r a p e u t i c .
s e t t i n g no treatment
no a p p l i c a t i o n s i n c e
doctors b e l i e v e
i t s purpose
they n e e d .
In
is
is
i n v o l v e d so
to ensure
the case of
In
the
the doctrine
that p a t i e n t s
nontherapeutic
s h o u l d have
get
the
t h e r a p e u t i c experimental ton,
the great p o t e n t i a l
f o r abuse of
authorities
that more p r o t e c t i o n should be given p a t i e n t s
suggest
volunteers because
to o b t a i n consent
the p r i v i l e g e p r e c l u d e s
the physician-experimenter
for an experiment
144
Generally,
s h i p s with
that e n a b l e
their patients
is
treatment.
the doctor who proposes
i n hopes of a recovery.
them to emphasize
mination and a b i l i t y
in order
to make r a t i o n a l
00320
-27-
the b e n e f i t s
during
indebted for past
the novel
to protect a p a t i e n t ' s
decisions,
than normal
dependency
is o f f e r e d
the experiment and may grasp at
Thus,
Accordingly,
position
than he w o u l d be
physicians establish
The p a t i e n t may be deeply
use.
u s u a l l y in a b e t t e r
p a t i e n t s when a p a r t i c u l a r experimental procedure
course o f
its
from h i s own p a t i e n t
w i t h a normal v o l u n t e e r .
treatment
authorities
relationto
the
care
to
therapy
self-deter-
argue
that
npre i n f o r m a t i o n
therapy s e t t i n g
145
should be d i s c l o s e d to a p a t i e n t
than to a normal v o l u n t e e r in
in the
experimental
the purely
experimental
situation.
This
traditional
f u n c i t o n s of the d o c t r i n e of informed
According
r a t i o n a l e becomes c l e a r e r w i t h
the Doctrine
to s c h o l a r s ,
concept of informed consent
the
in l e g a l w o r k s ,
of Informed
Consent
is a
"legal
law as a c a r d i n a l p r i n c i p l e for
146
of human r e s e a r c h .
Although the term i s w e l l - r e c o g n i z e d
the p r o p r i e t y
"informed
in
the
consent.
The Functions o f
h y b r i d " which has been accepted
judging
an understanding of
case
specific
remains an " i l l - d e f i n e d c o n c e p t " that
147
c o n s t r u c t i o n or e x p l a n a t i o n .
N e v e r t h e l e s s , one point i s c l e a r :
doctrine
r e q u i r i n g informed consent s a t i s f i e s
each i n d i v i d u a l ' s
own l i f e .
autonomy and h i s
Moreover,
by p r o v i d i n g
consent"
it i n c r e a s e s
right
safeguard against
and c r i m i n a l
S e c u r i n g informed consent
the proposed p r o j e c t
to protect
subjects.
public reaction
human
civil
in the p r o c e s s .
to experiments
The doctrine
to preserve
of
functions
injury
increasing society's
as a
to
to q u e s t i o n
the measures he has
the
the i n d i v i d u a l ' s
the
taken
adverse
awareness
about
Autonomy
right
right o f s e l f - d e t e r m i n a t i o n
to invade an i n d i v i d u a l ' s
integrity
t e c t i o n can only be meaningful
information
Individual
informed consent has dual p u r p o s e s ,
a patient's
By denying o t h e r s
sent,
process
148
research.
A.
is
the experimenter
informed consent also d i m i n i s h e s
while
his
encouraging
for non-negligent
and the adequacy o f
Requiring
and
the
respect
concerning
The doctrine a l s o
liability
forces
to
of the e x p e r i m e n t a l
the s u b j e c t with i n f o r m a t i o n about procedures
role
value o f
desires
to make d e c i s i o n s
the r a t i o n a l i t y
him to assume an a c t i v e
subjects.
society's
lacks
the
first
or i n d i v i d u a l
the i n d i v i d u a l
which
autonomy.
body w i t h o u t h i s
as a human b e i n g is p r o t e c t e d .
if
of
Such pro-
is provided with
to permit him to make up h i s own mind concerning
con-
enough
participation
in
the proposed experimental p r o c e d u r e .
was perhaps b e s t
when he
d e s c r i b e d by John
The concept of i n d i v i d u a l
Stuart M i l l
in his essay,
On
autonomy
149
Liberty,
stated:
[T]he sole end f o r which mankind are w a r r a n t e d , i n d i v i d u a l l y
or c o l l e c t i v e l y , i n i n t e r f e r i n g w i t h the l i b e r t y o f a c t i o n o f
any o f t h e i r number, i s s e l f - p r o t e c t i o n .
That the only purpose
for which power can be r i g h t f u l l y e x e r c i s e d over any member o f
a c i v i l i s e d community, a g a i n s t h i s w i l l , i s to p r e v e n t harm to
others.
His own good, e i t h e r p h y s i c a l or moral, i s not a suff i c i e n t warrant.
He cannot r i g h t f u l l y be compelled to do or
f o r b e a r because i t w i l l be b e t t e r for him to do s o , because
it w i l l make him h a p p i e r , because in the o p i n i o n s of o t h e r s ,
to do so would be w i s e , or even r i g h t .
These are good reasons
for remonstrating w i t h him, o r reasoning w i t h h i m , or p e r s u a d i n g
him, o r e n t r e a t i n g him, but not for compelling him, o r v i s i t i n g
him w i t h any e v i l in case h e . d o o t h e r w i s e .
To j u s t i f y t h a t , the
conduct from which i t is d e s i r e d to d e t e r him must be c a l c u l a t e d
to produce e v i l to someone e l s e .
The only part of the conduct
o f anyone, for which he i s amenable to s o c i e t y , i s that which
concerns o t h e r s .
In the part which merely concerns h i m s e l f ,
this independence i s , of r i g h t , a b s o l u t e .
Over h i m s e l f , over
h i s own body and mind, the i n d i v i d u a l i s s o v e r e i g n .
B.
Rational
Decision
The second purpose a s s o c i a t e d w i t h
is
to encourage
scrutinizing
procedures
b e i n g unduly performed and that
have
the f i n a l
decisions
is
that
by
those who assume
rational
decisions
for making the
such as p u b l i c
152
is
central
consent and an a p p r e c i a t i o n o f
the
The law views
approach
consent
achieved
through
that an experiment i s
to be the
rather
not
the experiment
151
result
if
The
argument
they are made
than by those who
recognition or career
advance-
decision.
The n o t i o n o f " r i s k "
quantitative
is
those who bear the risks o f
the r i s k of the d e c i s i o n s
ment,
analysis.
to assure
are more l i k e l y
have u l t e r i o r motives,
this
This purpose
as to whether or not i t is performed.
might
of
the doctrine of informed
r a t i o n a l d e c i s i o n making.
experimental
Making
that speaks
to the l e g a l meaning of
term i s e s s e n t i a l
risk
in
in qualitative
to an
understanding
terms and r e j e c t s
terms of p r o b a b i l i t i e s .
errs
informed
a
Nevertheless,
there i s no g e n e r a l agreement among courts
risks
that a p h y s i c i a n must d i s c l o s e .
of qualitative
risks
as
to the exact q u a l i t y
Many courts have r e c o g n i z e d
that must be d i s c l o s e d
to p a t i e n t s p r i o r
to
of
a number
153
treatment.
Still
o t h e r courts have h e l d that o t h e r e q u a l l y serious q u a l i t a t i v e r i s k s
154
need not be d i s c l o s e d .
This g e n e r a l i n c o n s i s t e n c y and l a c k of s p e c i f i c i t y
i n case law has l e d commentators to conclude
155
s u b j e c t for f e d e r a l r e g u l a t i o n .
VI.
While
Legal Limitations
on an I n d i v i d u a l ' s
there has been a g r e a t
deal of
consent
there remain l e g a l
to e x p e r i m e n t a t i o n .
defining
the scope o f
The f i r s t
means " t h e law does not r e c o g n i z e
the court with
a discretionary
up a c o n t r o l
group
for a research
risk of
the fact
self-determination
the area of
doctrines play
is
human
ability
to
major roles
in
de minimus non curat l e x ,
This w e l l - e s t a b l i s h e d
which
tenet arms
very minor w r o n g s .
that " a n e x t r a drop o f b l o o d
to b u i l d
study,
contracting polio
the advantage
that
trigger
the de minimus
pon f i t
Under this p r i n c i p l e
from the vaccine was not " s o
to recover nominal
Furtherdamages
doctrine.
doctrine which, l i m i t s an i n d i v i d u a l ' s
injuria,
trifling
158
to be gained as to be de m i n i m u s . "
an a c t i o n i s brought merely
159
The second l e g a l
is volenti
autonomy in
Consent
the d o c t r i n e i n cases i n v o l v i n g human experimenta15 7
Wyeth L a b o r a t o r i e s , the Ninth C i r c u i t h e l d that a one i n
I n Davis v .
w i l l not
to
to r e j e c t
i n comparison w i t h
more,
Ability
appropriate
or the use of t i s s u e that has been
156
severed would not be condemned by the c o u r t . "
However, some courts
do not h e s i t a t e
a million
an
power to overlook or ignore
one s c h o l a r p o i n t s out
tion.
is
to an i n d i v i d u a l ' s
trifles".
For example,
properly
limits
Two o l d l e g a l
consent.
this
d i s c u s s i o n about
and a strong movement f o r g r e a t e r i n d i v i d u a l
experimentation,
that
ability
to
meaning " t o one who i s w i l l i n g no wrong i s
an i n d i v i d u a l
may consent
ecs^
to a wide
consent
done."
range of a c t i v i t i e s
which
exposes him to risks
of
this
rule are
of serious
and permanent i n j u r y .
the a t h l e t e who v o l u n t a r i l y
and the i n d i v i d u a l who undertakes
i s not w i t h o u t e x c e p t i o n s .
to h i s own murder,
Common
participates
in sporting
a dangerous o c c u p a t i o n .
However,
At common law one was p r o h i b i t e d
to a duel or barroom b r a w l ,
a c t i v i t y which was c o n s i d e r e d
a "breach of
the
illustrations
to a maiming,
from
contests
the
consenting
o r to any
p e a c e " or a g a i n s t
rule
other
"public
160
policy".
exist
The r e s t r i c t i o n s
today l a r g e l y
health
on the v o l e n t i
because o f
and w e l f a r e o f
its
non f i t
the s t a t e ' s
citizens.
injuria
interest
doctrine
in maintaining
Consent by the v i c t i m
still
the
is no d e f e n s e
to
161
maiming o f
a
the human b o d y .
This
principle is illustrated
case i n which a doctor was convicted
thetizing
the f i n g e r s
to c l a i m i n s u r a n c e
Although
case,
of
to mayhem f o r
an i n d i v i d u a l who p l a n n e d to amputate
Bass,
anesr
them i n
order
proceeds.
this
r a t i o n a l e has not yet been invoked i n an
experimentation
there i s some i n d i c a t i o n
a r g u e d to d e f e a t c o n s e n t .
that such r e a s o n i n g could s u c c e s s f u l l y be
162
In Banovitch v . Commonwealth, a man c l a i m i n g
to be a doctor but who was i n
a woman w i t h
cancer o f
ten months a f t e r
chloride
doctors
practice
woman's
subject
the
testified
f a c t never l i c e n s e d ,
the n o s e .
treatment.
that had almost
used s a l v e s
The man was i n d i c t e d when
The s a l v e s
completely eroded
that such use of
contained
to
treat
the woman
a mixture of
the woman's n o s e .
At
the chemical was not s t a n d a r d
died
zinc
trial
medical
and not approved by the p r o f e s s i o n .
consent was " n o excuse
anyone performing
an experiment
to c r i m i n a l
manslaughter.
such
as an accessory
in State v .
The court concluded that the
163
for recklessness".
T h u s , i t is c l e a r that
i n a reckless o r wanton
charges of a s s a u l t and b a t t e r y ,
Moreover,
the s u b j e c t ' s
consent w i l l
charges.
-31-
fashion
or mayhem,
may be
o r even
not be a defense
to
VII.
Conclusion
E x p e r i m e n t a t i o n has always been a p a r t o f
formalized
clinical
and human s u b j e c t s
research
and the
are r e l a t i v e l y
of new medical procedures
the r e s p o n s i b i l i t y
voluntary
consent
recent developments.
physicians
in
research.
While
informed consent p r e s e r v e and promote i n d i v i d u a l
mination,
all
their
translation
those i n v o l v e d in
and a p p l y i n g
and medical
understood i s s u e i n
testing
have
informed,
the p r i n c i p l e s
of
autonomy and s e l f - d e t e r -
found i n
problems
for
Interpretting
the Nuremberg
to research with human s u b j e c t s
The d o c t r i n e o f informed
and l e a s t
and p r i n c i p l e s
the
subject's
into p r a c t i c e p r e s e n t d i f f i c u l t
ideas
and o t h e r s i m i l a r d o c t r i n e s
i n bo til the l e g a l
With
the area o f human e x p e r i m e n t a t i o n .
the e t h i c a l
creates
Code
dilemmas
communities.
consent is perhaps
the most
controversial
the area of human e x p e r i m e n t a t i o n .
It
has
become a f o c a l p o i n t i n the debate over human research both in
the
p r o f e s s i o n because o f
and i n
the medical malpractice
l e g a l p r o f e s s i o n because of
to protect human
stimulate,
research
federal
and i n v e s t i g a t i o n
and techniques
or r e s t r a i n
mentation p r e s e n t s
guard p a t i e n t s
the i n c r e a s e d
the e f f o r t s
of
the
research
dangerous
are s u b j e c t
by l e g a l s t a n d a r d s of care
to the implementation
the law seeks
the medical p r o f e s s i o n .
l e g a l problems
to d i r e c t
from standard medical p r a c t i c e
must
inhibiting
experimentaare
and n e g l i g e n c e
governed
cases.
discouraged by the l a w ' s
0C3ro
-32-
guide,
unduly
r e g u l a t i o n w h i l e others
is
to
Human experi-
Some areas of human
developed in malpractice
of
f o r courts w h i c h
and u n t r i e d methods w i t h o u t
the development of v a l u a b l e new t e c h n o l o g y .
Departure
crisis
regulation of
in medical p r a c t i c e ,
a number of s p e c i a l
against
tion and research
insurance
medical
subjects.
From c l i n i c a l
new procedures
but
investigator
and s c i e n t i s t s
of o b t a i n i n g a p o t e n t i a l
to p a r t i c i p a t e
of medicine
roles of p r o f e s s i o n a l
and t e c h n i q u e s ,
inherited
the s c i e n c e
practice
of
comparing a d o c t o r ' s
in
the
the
courts have made l e g a l
respective participants
rules
and procedures
these
rules
courts has
less,
to
the custom and p r a c t i c e
of h i s
peers
profession.
While
of
a c t i o n s with
is
in
for r e s o l v i n g c o n f l i c t s
f a r from uniform.
theme
underlies
This
informed,
the
among them,
rights
and
duties
inconsistency
the a p p l i c a t i o n
that p l a g u e s
for some t i m e .
every human e x p e r i m e n t a t i o n
e x p e r i m e n t i n g on an i n d i v i d u a l ,
competent,
about
the e x p e r i m e n t a t i o n p r o c e s s and about
vexed medical and l e g a l p r a c t i t i o n e r s
one broad
voluntary,
determinations
and understanding
-33-
consent.
of
American
Neverthe-
analysis:
the experimenter must o b t a i n
the
the
Prior
subject's
FOOTNOTES
1.
Term,
Annas,
The Rights of H o s p i t a l P a t i e n t s
2.
S l a t e r v . Baker and S t a p l e t o n ,
8 Geo. I l l , 1 7 6 7 ) .
3.
_Id.
4.
George J .
Consent
cited
George J .
Annas,
Leonard H.
to Human E x p e r i m e n t a t i o n :
as
Glantz
Eng.
Rep.
860
& Barbara F .
The S u b j e c t ' s
(1975).
(Michelmas
Katz,
Dilemma 2
Informed
(1977)
[hereinafter
Annas].
5.
See i n f r a ,
6.
Annas,
7.
60 B a r b .
8.
_Id.
9.
Annas,
10.
C.B.
100
at
notes
69-74 and accompanying
supra note 4 ,
488
(N.Y.
at
Sup.
sup ra note 4 ,
532,
39 P .
sticking
to the f o r e s k i n .
(Colo.
the s k i n ,
l e d to amputation o f
12.
30 W a s h .
13.
Id.
14.
Id.
15.
272 M i c h .
16.
_Id. at 2 7 4 ,
261 N . W .
at
763.
17.
^d.
261 N . W .
at
765.
18.
Annas,
sup ra note 4 ,
at
5.
at 2 7 6 ,
39 P .
70 P .
70 P.
at
at 5 8 0 .
9 72
(Wash.
_Id.
(emphasis
762
the head of the
applied
at 5 3 3 ,
added).
1902).
(Mich.
patient
1935).
penis
a "flaxseed
39 P .
at
meal
practice.
and caused gangrene
975.
261 N . W .
the
as was standard medical
the p e n i s .
20 Colo at 5 3 5 ,
273,
caused by
the condition
11.
352,
In J a c k s o n ,
The a t t e n d i n g p h y s i c i a n
method aggravated
349,
1895"),
a condition
i n s t e a d of s p l i t t i n g
at
1871).
3.
577
from a swollen p e n i s ,
ultimately
Ct.
at
suffered
The p h y s i c i a n ' s
2-3.
491-92.
20 C o l o .
poultice"
text.
which
578.
19.
287 N . Y .
262 A . D .
359,
372,
39 N . E . 2 d
29 N . Y . S . 2 d
913
(N.Y.
1942).
board found a p h y s i c i a n g u i l t y of
cancer
that
the d e c i s i o n of
the p h y s i c i a n
he had t e s t e d the
found
had c a l l e d on
Id.
bill.
the p a t i e n t was
20.
_Id.
at
363,
21.
U n i t e d States
Vol.11,
charged
39 N . E .
at 181.
in
court
The physi-
determined
that
the
the
after
court
treatment was
experi-
cured and the p h y s i c i a n who
times, n e v e r submitted
a
914-15.
at 9 1 6 .
(emphasis
added).
Karl Brandt,
For a d e s c r i p t i o n o f
regarding human e x p e r i m e n t a t i o n ,
Doctors o f
the C o n c e n t r a t i o n
experimental
medicine.
In a d d i t i o n ,
completely
of America v .
t r a n s l a t e d by tleinz Norden,
Services
at
for u s i n g an
licensing
for face cancer only
the p a t i e n t more than a hundred
39 N . E . 2 d
aff'd,
a New York
The a p p e l l a t e
treatment f o r s i d e - e f f e c t s .
at 361,
Criminals,
acts
the b o a r d .
1941),
to p r a c t i c e
used a t o p i c a l medication
Moreover,
Div.
I n Stammer,
license
that the p a t i e n t had been informed
mental.
App.
fraud and deceit
treatment and suspended h i s
cian appelaed
38 ( N . Y .
Infany
No.
1,
Trials
the s p e c i f i c
of War
criminal
see A.
Mitscherlich
(1949)
and Mant,
Camp of Ravensbruck,
F.
The
Mielke
Medical
17 Medico-Legal J .
99
(1950).
22.
The
Woetzel,
The Nuremberg T r i a l s
t r i b u n a l was e s t a b l i s h e d
Agreement,
f o r the
in
International
t r i a l of
war criminals
a compact executed by the United S t a t e s ,
and France on August
8,
1945.
Approximately
Law,
218-26
by the
Great B r i t a i n ,
four months
later,
London
Russia,
Allied
Control
Council o f Germany,
composed of the same n a t i o n s ,
Law No.
10 which a u t h o r i z e d
the a r r e s t and p r o s e c u t i o n of s u s p e c t e d war
criminals.
Later,
Ordinance
No.
7, e s t a b l i s h i n g
to try war c r i m i n a l s was i s s u e d by
Zone.
_Id.
which were
Each
tribunal
required
was
the m i l i t a r y
composed o f
to be American
lawyers,
issued
the
(1960).
the M i l i t a r y
governor o f
Tribunals
the American
three member j u d g e s ,
and an a l t e r n a t e
Control
all
of
selected
by the M i l i t a r y
Governor.
American p r o c e d u r a l
23.
Case)
Govt.
Experimentation
Tribunals:
Printing O f f i c e ,
i n Man,
^d.
Annas,
25.
U n i t e d States
Criminals,
1 9 4 7 at 2 : 1 8 1 - 8 4 ) ,
169 J . A . M . A .
Vol.
supra note 4 ,
461- 472-74
11,
at
at
(The
r e p r i n t e d in
(1959)
Medical
Beecher,
[reproduced
in
6.
of America v.
Karl Brandt,
_Id.
(emphasis
27.
M.
at 1 8 2 - 8 6 .
28.
Annas,
29.
Woetzel,
30.
Annas , supra no te 4 ,
31.
_Id.
(emphasis
at
at
8.
in
International
of e i t h e r
73-19434-AW
(Cir.
Ct.
33.
_Id.
34.
These codes may be viewed as " l a w "
supra note 4 ,
the e x p e r i m e n t e r .
at
Annas,
(1960).
if
into
researchers.
international
community.
Mich.,
July
Id.
10,
in
the sense
case i f
that
they may
they have been
conduct or c a r e .
The
adopted
physician's
by the code and the j u r y
would
the code p r o v i s i o n s had been v i o l a t e d by
supra note 4 ,
A A <71;?
1973).
150.
of
could be e s t a b l i s h e d
to determine
Wayne County,
i n a malpractice
by the medical p r o f e s s i o n as standards
customary
the research
Civil
be i n t r o d u c e d into evidence
222
care or duty owed by a l l medical
the standard accepted by
See A n n a s ,
Law,
8.
32.
then be a l l o w e d
o f War
the Nuremberg Code could be i n t r o d u c e d
to show the s t a n d a r d of
the s u b j e c t
Trials
added).
The Nuremberg T r i a l s
In c i v i l s u i t s
No.
1,
added).
supra note 4 ,
c r i m i n a l law o r as
No.
181.
26.
to
222.
T r i a l s of War C r i m i n a l s
The Code could be i n t r o d u c e d as evidence
duty
at
and
I]
24.
evidence
the prosecutors were American
rules were o b s e r v e d ,
Nuremberg M i l i t a r y
(U.S.
Appendix
Most o f
at
9.
35.
World Medical A s s o c i a t i o n ,
Code of Ethics of
Association
[ D e c l a r a t i o n of H e l s i n k i ] ,
at H e l s i n k i
in June 1 9 6 4 )
36.
[reproduced i n A p p e n d i x
American Medical A s s o c i a t i o n ,
Investigation
pamphlet p r i n t e d by the A M A ) ,
Havighurst e d .
37.
cited i n
and the Law 60-62
Public
Requirements
c i t e d as Medical
Ethics
in
Health S e r v i c e ,
to Insure
See i n f r a note 51 and accompanying
text.
40.
See supra note
41.
^d.
42.
See i n f r a notes. 50-5 3 and accompanying
43.
Memorandum on Group C o n s i d e r a t i o n
44.
Institutes
to I n s t i t u t e
supra note
Clinical
1966)
in
Declara-
Investigation
and the Law
(undated
6i,
n.
4
Progress].
Situation,
1969).
Including
Education,
Clinical
and W e l f a r e
of
36,
D i r e c t o r s et a l ,
at 6 2 ,
n.
[hereinafter
cited
_Id. at
46.
42 U . S . C .
47.
tiers h e y ,
sup ra note 4 4 ,
48.
52 S t a t .
1040
from D i r e c t o r ,
July
1,
1966,
Clinical
National
cited in
Insti-
Medical
7.
as
45.
text.
and Infromed Consent i n
of H e a l t h ,
Nathan Hershey & Robert D.
Law 1 ( 1 9 7 6 ) .
for
38.
the N a t i o n a l
tutes of Health
July
the Rights
39.
Progress,
Revised P o l i c y
(accepted
D e p ' t of H e a l t h ,
I n v o l v i n g Human S u b j e c t s ,
for Review
(1964)
the Consent
Havighurst e d .
1966.
at
30,
for C l i n i c a l
1,
Research
PPO 1 2 9 ,
(C.
Medical
II].
Medical Progress
Human E x p e r i m e n t a t i o n :
Investigaitons
Individuals,
177
Ethical Guidelines
Guidelines
[hereinafter
Surgeon G e n e r a l ,
and W e l f a r e ,
Research:
1969).
Fletcher,
Medical Progress
38.
J.
(approved by House o f D e l e g a t e s on Nov.
tion o f H e l s i n k i and AMA E t h i c a l
(C.
2 B r i t Med.
the W o r l d
Miller,
Human E x p e r i m e n t a t i o n and
the
Hershey]•
2.
§ 207
(1976).
(1938),
at
5.
as amended,
21 U . S . C .
§§301-92
(Supp.
II
1965-66).
49.
Hershey,
50.
See,
51.
The
supra note 4 4 ,
e.g.,
Id.
at
Pub.
Institutional
L.
No.
Guide
to PHEW Policy on the
in 1 9 7 1 .
93-348,
88 S t a t .
supra note 4 4 ,
54.
P r o t e c t i o n of Human S u b j e c t s ,
55.
Id.
56.
Annas,
57.
P r o t e c t i o n o f Human S u b j e c t s ,
58.
While such d e c i s i o n s were
supra note
81 S o . 2 d 6 5 8
60.
Similar
as a cure
Center Report 18-20
61.
81 S o . 2 d
62.
Id.
63.
However,
(codified
at 42 U . S . C .
§ 241
546.103(C)
(1980).
(1976)
6.
45 C . F . R .
46
at
45 C . F . R .
§ 46.110
43.
rare,
from minor donors.
(Fla.
1955)
(en
for c a n c e r .
(Dec.
(1980).
there was a s e r i e s
Annas,
of
cases
sup ra note 4 ,
at
the controversy
See Case Study on L a e t r i l e ,
over the
The
drug,
Hastings
1976).
at 6 6 0 .
(emphasis
on r e h e a r i n g ,
various o p t i o n s
that
added).
the court p l a c e d the r e s p o n s i b i l i t y
to the p a t i e n t on the
the experimental
of
investigator/experimenter
treatment was not
effective.
stated:
A l l of the medical testimony emphasizes the fact that time i s
of the essence i n t r e a t i n g c a n c e r .
I t is the d o c t o r , and not
the p a t i e n t , who h o l d s himself out to b e , and must b e , b e s t
equipped to detect the warning s i g n s .
And when treatment is
i n e f f e c t i v e , it is the doctor who must know i t f i r s t and recommend o t h e r a c t i o n .
Id.
at 6 6 2 .
(emphasis
9.
banc).
issues were d i s c u s s e d in
became obvious
court
4,
transplants
59.
when i t
of
§46.109.
tissue
disclosing
at
342
Hershey,
laetrile,
Protection
Id.
5 3.
involving
The
6.
5.
Human S u b j e c t s was p u b l i s h e d
52.
at
added).
).
in
64.
26 A . D . 2 d
693,
272 N . Y . S . 2 d
557
(N.Y.
65.
In 1966 when F i o r t i n o was d e c i d e d ,
The surgeon used a technique on the p l a i n t i f f
operations
case.
nad
unexpected
results,
including
the use of
a s t e e l bar or " s p i n a l
the p l a i n t i f f ' s
6 7.
_Id.
at 6 9 5 ,
no independent
.
.
One j u d g e ,
however,
obligation
"to
. an informed
at
_Id.
dissented,
go behind such
69.
493 F.2d
70.
Annas,
71.
K a r p ' s w i f e based her action on D r .
Tue t r i a l
w i t h Mr.
court
general
found
tnat D r .
in one
jack"
272 N . Y . S . 2 d
at
of
son
558.
arguing that
the h o s p i t a l
to a s c e r t a i n
had
whether
text.
1974).
11.
Cooley1s
Cooley had e x p l a i n e d
two o c c a s i o n s .
forms on two o t h e r o c c a s i o n s .
consent
five
As a r e s u l t
alleged
consent f o r such an unusual and e x p e r i m e n t a l
Karp on at l e a s t
two consent
at
himself
Id.
note 65 and accompanying
sup ra note 4 ,
scoliosis.
fourteen year o l d
consent
See supra
(5th C i r .
one
559.
consent had been g i v e n . "
408
column.
at 6 9 4 ,
68.
adequate informed
The
272 N . Y . S . 2 d
times;
complete p a r a l y s i s
undergoing
d i e d from " e x s a n g u i n a t i n g h e m o r r h a g e " .
for
that he had developed
the v e r t e r b r a l
this surgical procedure,
the only
type of surgery
which was i n s e r t e d and screwed i n t o
Id.
1966).
The procedure nad been used t h i r t y - f i v e
The o p e r a t i o n i n v o l v e d
66.
Div.
the surgeon was
the U n i t e d States who performed a p a r t i c u l a r
f i v e years b e f o r e .
App.
Moreover,
One of
failure
operation.
and d i s c u s s e d
the
the p a t i e n t had
the
to get
procedure
executed
consent forms was
form r e q u i r e d by the h o s p i t a l which Karp s i g n e d upon
the
admission.
form s t a t e d :
I hereby a u t h o r i z e the p h y s i c i a n or p h y s i c i a n s i n charge o f
H a s k e l Karp to a d m i n i s t e r any treatment; or to a d m i n i s t e r
such a n e s t h e t i c s and perform such o p e r a t i o n as may be deemed
necessary or a d v i s a b l e in the d i a g n o s i s and treatment of t h i s
patine t.
Karp v.
408
Cooley,
(5th Cir.
Tnis
349 F.
Supp.
827,
general " b l a n k e t "
of s p e c i f i c i t y .
statement of
consent
relied exclusively
uis
case i n s t e a d of w i n n i n g . "
upon
73.
See supra note
74.
349 F.
Supp.
75.
Annas,
sup ra note 4 ,
77.
Id.
78.
Id.
79.
that sue did not
noting
to read
to
at
F.2d
at 1 3 .
orally
that l e g a l l y
because of i t s
the form he s i g n e d ,
80.
2d.
at
423.
81.
Annas,
Cooley
at
lost
12.
text.
As
there was
evidence
that her husband
the surgery.
Karp's
Karp had the power and
that Mr.
the court p o i n t e d out that Texas
sup ra note 4 ,
at
allegation
the e x p e r i m e n t a l n a t u r e o f
for her contention
that Karp was
had
Id.
as i r r e l e v a n t Mrs.
only Mr.
form by v i r t u e of his s i g n a t u r e ,
421.
Dr.
lack
1974).
At t r i a l ,
the e x t e n t of
the o p e r a t i o n .
at
(5th C i r .
to K a r p ' s w i f e
rejected
understand
493 F.2d
failed
831.
firmly
the j u r y be i n s t r u c t e d
it.
493
form he would probably have
71 and accompanying
chance o f s u r v i v i n g
The court
to consent
aff'd,
consent has t r a d i t i o n a l l y
supra note 4 ,
493 F.2d 408
Cooley e x p l a i n e d
a seventy-thirty
surgery,
Cooley,
Annas,
Karp v.
Id.
1972),
f o r medical operations
this consent
72.
76.
Tex.
At l e a s t one commentator has noted that " [ i ] f
had
Dr.
(S.D.
19 7 4 ) .
to serve as s u f f i c i e n t
that
829
charged with
reading
the
authority
Karp
failed
law
required
consent
r e g a r d l e s s o f whether he a c t u a l l y
12.
the
read
L.
82.
Id.
83.
Jtd.
84.
JEd. at
85.
See supra notes 46-50
86.
National
87.
Annas,
88.
Christian
Levy,
Institute
and accompanying
of H e a l t h G u i d e ,
supra note 4 ,
Barnhard,
The human Body and
at
90.
E.
Tnorwald,
91.
_Id.
at 2 4 6 .
92.
Id.
at
93.
Annas,
94.
Committee on E t h i c s o f
(Feb.
23,
1976).
Redefining
Vand.
L.
of
supra note 4 ,
the L e f t
_Cf.
Rev.
243
1974).
(1969).
See g e n e r a l l y ,
Charlotte
57-63
(1971).
added).
G.
at
16.
the American Heart A s s o c i a t i o n ,
Ventricular Assist
Annas
& E.
Healey,
Device,
235 J . A . M . A .
The P a t i e n t
in
Ethical
823
R i g h t s Advocate -
the H o s p i t a l
Context,
27
(1974).
_Id.
97.
52 W . W . R .
98.
_Id. at
99.
Waen
at
608
823.
(Sask.
1965).
609.
the student
he was
7,
(19 7 5 ) .
the Doctor-Patient R e l a t i o n s h i p
96.
told
home, not in
100.
(emphasis
(Aug.
17.
The P a t i e n t s
sup ra note 4 ,
235 J . A . M . A .
i n his
at
3:11
248-50.
95.
form,
348
the Law 51-52
Annas,
text.
14.
One L i f e
89.
Considerations
the
13-14.
52 W . W . R .
that
i n q u i r e d about
the
term referred
the h o s p i t a l .
at 6 1 6 - 1 7 .
the " a c c i d e n t s "
_Id.
at
(emphasis
to a c c i d e n t s
611.
added).
GG334
referred
to
that might
in
occur
101.
338,
iiyman v .
258 N . Y . S . 2 d
102.
c i t e d as
397
Jay K a t z ,
Chronic D i s e a s e IIosp.,
(N.Y.
Ct.
against
W i l l i a m A.
Hyman,
records,
whetaer a hospital
alleging
to p a t i e n t
patients
records
director
(1972).
[hereinafter
206 N . E . 2 d
N.Y.
105.
Katz,
f a c t as " [ a ] n y
at 339-40,
Educ.
supra note 1 0 2 ,
f a c t which might
106.
Id.
107.
See i n f r a notes
108.
Annas,
109.
Waltz & Inbau,
110.
_Id.
supra note 4 ,
the d i r e c t o r ' s
l o s s of
stapedectomy o p e r a t i o n s .
Schloendorff
v.
at
(Consol.
influence
to which
medical
in
records.
access
hospital's
15
N.Y.2d
399-400.
1962).
a material
the g i v i n g or w i t h h o l d i n g
of
text.
152-56
Wilson, 412
the a c t i o n s of
(1971).
S . W . 2 d 299
a lower court
for f a i l i n g
nearing which occurs
Soc'y
the a c t i o n was
interest
the
not
27.
in Scott v .
_IcL at
in
The Committee d e f i n e d
to hold a doctor l i a b l e
total
involved
disclosure
the immune r e a c t i o n e x p e r i m e n t s .
at 6 0 .
at
the
to look at p a t i n e t ' s
Medical Jurisprudence
Supreme Court a f f i r m e d
tne p o s s i b l e
issue
140-42 and accompanying
For i n s t a n c e ,
theory
legal
258 N . Y . S . 2 d
Law § 6 5 1 4 ( 2 )
Id.
tne battery
d i r e c t o r s had
that would show the e x t e n t
consent."
the Texas
that approval of
recognized
in
took a p o s i t i o n
to force
is e n t i t l e d
nad been made s u b j e c t s
104.
111.
N.E.2d
brought l e g a l a c t i o n
The i n i t i a l
The New York Court of Appeals
of
9
a member of the board who
the cancer e x p e r i m e n t a t i o n ,
tne u o s p i t a l ' s
318,
206
1965).
Experimentation With Human Beings
been properly o b t a i n e d .
at
App.
15 N . Y . 2d 3 1 7 ,
Katz].
103.
of
Jewish
(Tex.1967),
that
to advise
invoked
his
i n one percent o f
patient
all
304.
of New York iiosp. , 211 N . Y .
125,
105 N . E .
92,
93
(N.Y.
(Wis.
Ct.
App.
1914).
112.
Canterbury v .
113.
Annas,
114.
Trogun v.
Spence,
supra note 4 ,
Frutchtman,
464 F.2d
772,
780
(D.C.
Cir.
1972).
at 2 8 .
58 W i s .
2d 5 9 6 ,
601,
207 N . W . 2 d
29 7,
313
1973).
115.
Id.
116.
_Id.
117.
Id.
118.
_Id.
119.
Annas,
120.
See supra note
patinet
supra note 4 ,
in a n e g l i g e n c e
toward h i m ;
patient;
(2)
and
that
(4)
121.
Id.
122.
JOd.
123.
110 R . I .
±24.
Id.
at
125.
464
F.2d
126.
^Id.
at
127.
8 Cal.
128.
1 1 3 and accompanying
duty was b r e a c h e d ;
text.
617,
772
295 A . 2 d 676
(R.I.
295 A . 2 d at 6 8 8 .
(D.C.
Cir.
(emphasis
plaintiff-
the p h y s i c i a n
had a duty
(3)
that damages o c c u r r e d to
the breach of d u t y .
Id.
the
at
1972).
added).
1972).
added).
502 P . 2 d
1,
Id.
at 237-40,
502 P . 2 d
at 10-12,
129.
Id.
at 2 3 9 ,
130.
See supra notes
131.
Annas,
132.
See supra notes
at 1 1 ,
104 Cal.
Rptr.
at
505
104 C a l .
104 C a l .
Rptr.
122-27 and accompanying
supra note 4 ,
the
that
(emphasis
3d 2 2 9 ,
502 P . 2 d
Briefly,
(1)
the damages were caused by
606,
784.
28.
a c t i o n must prove:
the
that
at
Rptr.
515.
text.
30.
123-128 and accompanying
(Cal.
text.
1972)
514-16.
(en
banc).
133.
Annas,
134.
jtd.
supra note 4 ,
Courts
at
rejecting
31.
the battery
theory have also been
that doctors would be unduly burdened by a requirement
what,
if any, individual
quirks,
ideas,
or b e l i e f s ,
that would induce
him to r e f u s e o t h e r w i s e
ment.
Canterbury
See,
135.
person"
e.g.,
For example,
with
v.
Spence,
i n Cobbs,
risk.
464 F . 2 d
a duodenal u l c e r would have agreed
3d 238-39,
136.
464
137.
Annas,
138.
Jji.
be allowed
F . 2 d at
502 P . 2 d
772,
Authorities
to waive h i s
right
(D.C.
104 C a l .
19 7 2 ) .
a "reasonable
to an o p e r a t i o n
of
Cir.
treat-
the f i v e
Rptr.
knowing
in
his
percent
515-16.
31.
that
to this
Ld.
140.
464
141.
Id.
142.
8 Cal.
3d 238-39,
14 3.
Ann a s ,
supra note 4 ,
144.
A.
145.
JEd., A n n a s ,
146.
Katz,
147.
Id.
148.
Td.
149.
London:.
150.
Katz,
at
at
maintain
139.
Capron,
have
789.
supra note 4 ,
F . 2 d at
789
that an ulcer w o u l d develop
at 1 1 - 1 2 ,
determine
r e c o g n i z e d medical
the p h y s i c i a n need not make the d i s c l o s u r e
8 Ca1.
they
the p a t i e n t might
the court h e l d that i f
that there was a f i v e p e r c e n t chance
stomach,
commonly
that
concerned
the i n d i v i d u a l
information.
JLd.
should not
at
even
32.
789.
502 P . 2 d
at
at 1 2 ,
104 C a l .
Rptr.
515.
32.
The New G e n e t i c s and the Future o f Man 1 5 1
supra note 4 ,
supra note 1 0 2 ,
at
at
33.
523.
524.
John W.
supra note
Parker
102,
& Son 21-23
at
540.
O03fi7
(1859).
(1972).
151.
Annas,
152.
Dr.
s up ra note 4 ,
Francis
at
36.
Moore supported
this argument when he
stated:
There can be l i t t l e q u e s t i o n that p e r s o n a l a m b i t i o n , u s u a l l y for
career advancement or p u b l i c a c c l a i m , u n d e r l i e s much i n t e n s e much
i n t e n s e motivation i n research work and i n the t r i a l o f new i d e a s ,
drugs, o p e r a t i o n s , or treatment.
Such p e r s o n a l ambition i s usually
w e l l hidden under the s o p h i s t i c a t e d a f f e c t [ s i c ] o f the d e d i c a t e d
c l i n i c a l s c i e n t i s t a n d , f a r from being r e m i s s , is the s i g n of a
healthy s o c i e t y . . . But a m b i t i o n , no matter how p r a i s e w o r t h y ,
can c e r t a i n l y l e a d i n d i v i d u a l s a s t r a y .
Mechanic,
The Growth of B u r e a u c r a t i c Medicine
153.
E.g.,
Campbell v .
to open mouth completely
251 M i n n .
427,
liarnette v .
( amputation
154
-
(vescovaginal
350 F.
Supp.
x-rays),
from
Bell v.
1958)
2d 5 1 ,
F . 2 d 1244
(6th
3ang v .
(sterility
Cir.
1970)
Charles
T.
432
(N.Y.
Sup.
382 F.
503
(E.D.
Pa.
(inability
Miller
from p r o s t a t e
359 N . Y . S . 2 d
Garfield,
from h y s t e r e c t o m y ) ,
(E.D.
(19 7 6 ) .
Hosp.,
operation),
Ct.
1974)
operation).
Bowers v .
fistula
554
(Minn.
79 M i s c .
from f i n g e r
E.g.,
424
a f t e r jaw o p e r a t i o n ) ,
88 M . W . 2 d 1 8 6
Potenza,
Olivia,
261
Pa.
1972)
Ulmstattd,
Ciccarone
(paralysis
401 S . W . 2 d
306
Supp.
v.
United
from contrast
(Tex.
1966)
1974)
States,
media use
(injury
in
to vocal
cords
anesthesia).
155.
Annas,
156.
Kidd,
on h i m s e l f ,
157.
supra note 4 ,
Limits o f
117S_ci.
212
399 F . 2 d 121
at 1 2 9 .
(9th
_Id.
159.
See g e n e r a l l y ,
160.
Annas,
161.
255 N . C .
162.
196 Va.
210,
27,
Cir.
(emphasis
44-45,
to Consent
to
1953).
1968).
added).
22 Am. J u r .
supra note 4 ,
42,
54.
the Rights of a Person
(Feb.
158.
at
at
2d Damages
(1967).
51.
120 S . E . 2 d
83 S . E . 2 d
§ 5
369
(Va.
580,
583
1954).
(N.C.
1961).
Experimentation
163.
Id.
at 215-16,
83 S . E . 2 d
at
375.
The court
for a new t r i a l on a s s a u l t and battery so that
instructions
on the i s s u e s
of i n t e n t
%J
the j u r y
remanded
could
and criminal n e g l i g e n c e .
'*
%J
the
case
receive
Id.
proper
APPENDIX I
Tne Nuremberg Code
1.
The voluntary consent o f the human s u b j e c t is a b s o l u t e l y essential.
This means that the person i n v o l v e d should have l e g a l c a p a c i t y
to give c o n s e n t : should be so s i t u a t e d as to be able to e x e r c i s e f r e e
power o f choice without the i n t e r v e n t i o n o f any element of f o r c e , f r a u d ,
d e c e i t , d u r e s s , o v e r r e a c h i n g , or o t h e r u l t e r i o r form of c o n s t r a i n t o r
c o e r c i o n and should have s u f f i c i e n t knowledge and comprehension o f the
elements o f the s u b j e c t matter i n v o l v e d as to enable him to make an
understanding and e n l i g h t e n e d d e c i s i o n .
This l a t t e r element r e q u i r e s
that b e f o r e the acceptance of an a f f i r m a t i v e d e c i s i o n by the e x p e r i mental s u b j e c t there should be made known to him the n a t u r e , d u r a t i o n ,
and purpose of the e x p e r i m e n t ; the method and means by which i t i s to
be c o n d u c t e d ; a l l i n c o n v e n i e n c e s and hazards reasonably to be e x p e c t e d ;
and the e f f e c t s upon his health or person which may p o s s i b l y come from
h i s p a r t i c i p a t i o n i n the e x p e r i m e n t .
The duty and r e s p o n s i b i l i t y for a s c e r t a i n i n g the q u a l i t y of the
consent rests upon each i n d i v i d u a l who i n i t i a t e s , d i r e c t s , or engages
i n tne e x p e r i m e n t .
I t is a personal duty and r e s p o n s i b i l i t y which
may not be d e l e g a t e d to anotner w i t h impunity.
2.
The experiment should be such as to y i e l d f r u i t f u l r e s u l t s
f o r tne good of s o c i e t y , unprocurable by o t h e r methods or means of
s t u d y , and not random and unnecessary in n a t u r e .
3.
The experiment s h o u l d be so d e s i g n e d and b a s e d on the r e s u l t s
o f animal e x p e r i m e n t a t i o n and knowledge of the n a t u r a l h i s t o r y of the
d i s e a s e o r o t h e r problem under study that the a n t i c i p a t e d r e s u l t s w i l l
j u s t i f y the performance of the e x p e r i m e n t .
4.
The experiemnt s h o u l d be so conducted as to a v o i d a l l
sary p n y s i c a l and mental s u f f e r i n g and i n j u r y .
unneces-
5.
No experiemnt should be conducted where there is an a p r i o r i
reason to b e l i e v e that death or d i s a b l i n g i n j u r y w i l l o c c u r ; e x c e p t ,
perhaps i n those experiemnts where the experiemntal p h y s i c i a n s also
serve as s u b j e c t .
6.
The degree o f r i s k to be taken should never e x c e e d that
determined by the humanitarian importance of the problem to be s o l v e d
by the e x p e r i m e n t .
7.
Proper p r e p a r a t i o n s should be made and adequate f a c i l i t i e s
p r o v i d e d to protect the experimental s u b j e c t a g a i n s t even remote
p o s s i b i l i t i e s of i n j u r y , d i s a b i l i t y , or d e a t h .
8.
Tiie experiment s h o u l d be conducted only by s c i e n t i f i c a l l y
q u a l i f i e d persons.
The h i g h e s t degree of s k i l l and care should be
r e q u i r e d through a l l s t a g e s of the experiment of those who conduct
or engage i n the e x p e r i m e n t .
9.
During the course of the experiment the human s u b j e c t s h o u l d
be at l i b e r t y to b r i n g the experiment to an end i f he has reached the
p h y s i c a l or mental s t a t e where c o n t i n u a t i o n of the experiment seems
to him to be i m p o s s i b l e .
10.
During the course of the experiment the s c i e n t i s t in charge
must be prepared to terminate the experiment a t any s t a g e , i f he has
probable cause to b e l i e v e , in the e x e r c i s e of the good f a i t h , s u p e r i o r
s k i l l , and c a r e f u l judgment required of him, that a c o n t i n u a t i o n o f
the experiment is l i k e l y to r e s u l t in i n j u r y , d i s a b i l i t y , or death to
the experimental s u b j e c t .
APPENDIX I I
D e c l a r a t i o n of H e l s i n k i , 1 9 6 4
World Medical A s s o c i a t i o n
It
people.
o f this
is the mission of the doctor to s a f e g u a r d the h e a l t h of the
His knowledge and conscience are d e d i c a t e d to the f u l f i l m e n t
mission.
The D e c l a r a t i o n o f Geneva of the World Medical A s s o c i a t i o n ( 1 9 6 4 )
b i n d s the doctor with the w o r d s , " T h e health of my p a t i e n t w i l l be my
f i r s t c o n s i d e r a t i o n ! ' ; and the I n t e r n a t i o n a l Code of Medical Ethics which
d e c l a r e s that "Any act
or a d v i c e which could weaken p h y s i c a l or mental
r e s i s t a n c e of a human b e i n g may be used only in h i s i n t e r e s t . "
Because i t i s e s s e n t i a l that the r e s u l t s of l a b o r a t o r y experiments
be a p p l i e d to human b e i n g s to f u r t h e r s c i e n t i f i c knowledge and to help
s u f f e r i n g humanity, the W o r l d Medical A s s o c i a t i o n has prepared the following recommendations as a guide to each doctor i n c l i n i c a l r e s e a r c h .
I t must be s t r e s s e d that the standards as d r a f t e d are only a guide to
p h y s i c i a n s a l l over the w o r l d .
Doctros are not r e l i e v e d from c r i m i n a l ,
c i v i l , and e t h i c a l r e s p o n s i b i l i t i e s under the laws o f t h e i r own c o u n t r i e s .
I n the f i e l d of c l i n i c a l research a fundamental d i s t i n c t i o n must be
r e c o g n i z e d between c l i n i c a l research in which the aim i s e s s e n t i a l l y
t h e r a p e u t i c for a p a t i e n t , and c l i n i c a l research the e s s e n t a i l o b j e c t
of which i s purely s c i e n t i f i c and w i t h o u t t h e r a p e u t i c value to the person
s u b j e c t e d to the r e s e a r c h .
I.
Basic
Principles
1.
C l i n i c a l r e s e a r c h must conform to the moral and s c i e n t i f i c
p r i n c i p l e s that j u s t i f y medical r e s e a r c h , and should be based on
laboratory and animal experiments or other s c i e n t i f i c a l l y e s t a b l i s h e d
facts.
[The use of animals i s not always f e a s i b l e o r p o s s i b l e . ]
2.
C l i n i c a l r e s e a r c h should be conducted only by s c i e n t i f i c a l l y
q u a l i f i e d persons and under the s u p e r v i s i o n of a q u a l i f i e d medical man.
3.
C l i n i c a l research cannot l e g i t i m a t e l y be c a r r i e d out unless the
importance of the o b j e c t i v e i s i n proportion to the inherent r i s k to the
subject.
4.
Every c l i n i c a l research p r o j e c t should be preceded by c a r e f u l
assessment o f i n h e r e n t r i s k s i n comparison to f o r e s e e a b l e b e n e f i t s to
the s u b j e c t or to o t h e r s .
5.
clinical
S p e c i a l c a u t i o n should be e x e r c i s e d by the doctor in performing
research in w h i c h the p e r s o n a l i t y of the s u b j e c t is l i a b l e to
to be a l t e r e d by drugs o r experimental
II.
Clinical
procedure.
Research Combined w i t h P r o f e s s i o n a l
Care
1.
I n the treatment o f the s i c k person the doctor must be f r e e to
use a new
t h e r a p e u t i c measure, i f i n h i s judgment i t o f f e r s hope o f
s a v i n g l i f e , r e - e s t a b l i s h i n g h e a l t h , or a l l e v i a t i n g s u f f e r i n g .
I f at a l l p o s s i b l e , c o n s i s t e n t w i t h p a t i e n t p s y c h o l o g y , the d o c t o r
should o b t a i n the p a t i e n t ' s f r e e l y given consent a f t e r the p a t i e n t has
been given f u l l e x p l a n a t i o n .
In case o f l e g a l i n c a p c i t y consent s h o u l d
also be procured from the l e g a l g u a r d i a n ; i n case o f p h y s i c a l i n c a p a c i t y
the permission o f the l e g a l guardian replaces that o f the p a t i e n t .
2.
The doctor can combine c l i n i c a l research w i t h p r o f e s s i o n a l c a r e ,
the o b j e c t i v e b e i n g the a c q u i s i t i o n of new medical k n o w l e d g e , only to the
extent that c l i n i c a l r e s e a r c h i s j u s t i f i e d by i t s t h e r a p e u t i c v a l u e f o r
the p a t i e n t .
III.
Non-Therapeutic C l i n i c a l
Research
1.
I n the p u r e l y s c i e n t i f i c a p p l i c a t i o n of c l i n i c a l research c a r r i e d
out on a human b e i n g i t i s the duty o f the doctor to remain the p r o t e c t o r
of the l i f e and h e a l t h o f that person on whom c l i n i c a l research i s b e i n g
carried out.
2.
The n a t u r e , the p u r p o s e , and the r i s k of
be e x p l a i n e d to the s u b j e c t by the d o c t o r .
clinical
research
must
3a.
C l i n i c a l research on a human being cannot be undertaken w i t h o u t
h i s free c o n s e n t , a f t e r he has been f u l l y i n f o r m e d ; i f he i s l e g a l l y incompetent the consent o f the l e g a l g u a r d i a n should be p r o c u r e d .
3b.
physical,
choice.
The s u b j e c t o f c l i n i c a l research should be i n such a m e n t a l ,
and l e g a l s t a t e as to be able to e x e r c i s e f u l l y h i s power o f
3c.
Consent should as a rule be o b t a i n e d in w r i t i n g .
However, the
r e s p o n s i b i l i t y f o r c l i n i c a l research always remains w i t h the research
w o r k e r ; i t never f a l l s on the s u b j e c t , even a f t e r consent is o b t a i n e d .
4a.
The i n v e s t i g a t o r must respect the right o f each i n d i v i d u a l
s a f e g u a r d h i s p e r s o n a l i n t e g r i t y , e s p e c i a l l y i f the s u b j e c t is i n a
dependent r e l a t i o n s h i p to the i n v e s t i g a t o r .
to
4b.
At any time during the course of c l i n i c a l research the s u b j e c t
or h i s g u a r d i a n should be free to withdraw p e r m i s s i o n f o r research to be
continued.
The i n v e s t i g a t o r or the i n v e s t i g a t i n g team should d i s c o n t i n u e
the research i f in h i s o r t h e i r judgment i t may, i f c o n t i n u e d , be harmful
to the i n d i v i d u a l .