Paper Submitted for Credit
In
Bioethics
PSYCHOLOGICAL EXPERIMENTATION ON INSTITUTIONALIZED
HUMAN SUBJECTS: SELECTED LEGAL ISSUES
by
Donna Quinn
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I
INTRODUCTION
Understanding the workings of the human mind appears to be as d i f f i c u l t
as perceiving the legendary elephant, with the f i v e b l i n d perceivers
the diverse r e a l i t i e s of the v a r i o u s l y i n t e r e s t e d d i s c i p l i n e s :
logy, s o c i o l o g y , law and philosophy.
representing
Medicine, psycho-
This genuine search for understanding has
been the source of much c o n f l i c t in the l a s t decade as various factions from the
above d i s c i p l i n e s have argued that biomedical and behavioral research are
fundamentally necessary in order to develop modern techniques to combat the
physical, sociological
and psychological
argue j u s t as f o r c e f u l l y f o r individual
integrity.
problems o f humanity; while others
l i b e r t y , human d i g n i t y and bodily
The focus of t h i s paper s h a l l be that of psychological
experimenta-
t i o n , both biomedical and behavioral which has been v i s i t e d upon those
institu-
t i o n a l i z e d i n d i v i d u a l s l a b e l l e d mentally i l l , along with the legal and e t h i c a l
considerations which are inherent in t h i s
topic.
II
RATIONALE FOR PSYCHOLOGICAL EXPERIMENTATION:
PRO AND CON
The theoretical purpose behind psychological experimentation i s
that
of r e l i e v i n g mental s u f f e r i n g and achieving p o s i t i v e behavior modification as well
as that o f advancing mankind's knowledge about the human mind.
This purpose
creates a b a s i c c o n f l i c t between the "worth" of a human being and his
liberty
of mentation on the one hand, and the e x u l t a t i o n of the achievement of knowledge
on the other; stated another way, between i n d i v i d u a l needs and r i g h t s and
societal benefits.
When one weighs the questionable s o c i a l benefits of p s y c h o l o g y
00002
organic experimentation against the incumbent harms, the price demanded from
the i n d i v i d u a l seems an excessive one to pay j u s t to be considered a part of the
"community" e s p e c i a l l y i f that community has committed him against h i s w i l l
to
an i n s t i t u t i o n , and there are no guarantees that he w i l l benefit p e r s o n a l l y
from the procedure.
I n s t i t u t i o n a l i z e d subjects have long been the f a v o r i t e
subjects of researchers.
Whether the protocal c a l l s f o r a long-term s t u d y , or
a c o n t r o l l e d population or a c o n t r o l l e d environment, the "mental
institution"
has been h i g h l y a c c e s s i b l e , and i t s population because o f the dehumanization
of active c a t e g o r i z a t i o n , i s prime material for experimentation.
The concept of mental i l l n e s s i s l i t t l e more than a theoretical
construct, yet i t i s used to deprive i n d i v i d u a l s of t h e i r l i b e r t y , physical and
mental i n t e g r i t y , and the a b i l i t y to make d e c i s i o n s about themselves, and often
makes them l i k e l y candidates f o r psychological experimentation.
what degree t h i s construct i s applied to an i n d i v i d u a l
philosophical bias of the person in a u t h o r i t y .
Whether and to
depends on the p a r t i c u l a r
The p o s i t i v i s t s c h o o l , grounded
in the psycho-analytic theory of Sigmund Freud, regards mental i l l n e s s in the
same manner that i t regards physical i l l n e s s :
and treatable phenomenon J
of treatment.
As an o b j e c t i v e l y r e a l , diagnosabl
This approach uses the medical model f o r i t s
protocal
R.D. Laing in a c r i t i c a l d e s c r i p t i o n of t h i s approach has commente
that " w i t h i n the p o s i t i v i s t framework, the p r a c t i t i o n e r thinks of mental
physicology and mental pathology, looks f o r s i g n s and symptoms, makes h i s
diagnosis and assesses the i n d i v i d u a l ' s p r o g n o s i s , and prescribes treatment or
experimentation.^
Within t h i s school with i t s bent for c l a s s i f i c a t i o n and
c a t e g o r i z a t i o n , there i s much disagreement on the- i n i t i a l
3
d i a g n o s t i c question of
whether the i n d i v i d u a l
i s , in f a c t , mentally i l l .
Once that hurdle i s
there i s further disagreement as to which mental i l l n e s s :
or p e r s o n a l i t y disorder.
But because the i n d i v i d u a l
lept,
Psychosis, neurosis,
i s viewed as " i l l " he
must be " t r e a t e d , " and i f h i s treatment involves experimental
procedures--
so be i t ; he must be made whole--the disease must be cured.
The other approach i s that of the phenomenological school which
rejects the medical model for one that i s more s e l f - c o g n i z a n t ,
and s e l f - d e t e r m i n i s t i c . ^
self-reflective
This approach recognizes that i n d i v i d u a l s do experience
problems in l i v i n g and r e l a t i n g to the outside world which at times may be
quite severe; but i t does not recognize t h i s phenomenon as an i l l n e s s in a
medical sense.^
over the s o c i a l
Phenomenologists l i k e Laing and Thomas Szaz voice much concern
and legal
r a m i f i c a t i o n s of l a b e l l i n g someone who e x h i b i t s
deviant
behavior "mentally i l l " and then t r e a t i n g and experimenting on him a c c o r d i n g l y .
Once the person has been so l a b e l l e d , i t appears that s o c i e t y feels
itself
j u s t i f i e d in dealing with him in a way that i t would not, nor could not deal
with someone not so l a b e l l e d .
Defining and c a t e g o r i z i n g the individual
him--in h i s own eyes and in the eyes of the experimentor-researcher.
dehumanizes
Viewing him
in t h i s manner gives l i t t l e cause for r e f l e c t i o n about i n v a s i o n of fundamental
rights.
Until recent Court d e c i s i o n s , i t appeared that i n d i v i d u a l s who have
been l a b e l l e d mentally i l l
and committed to mental i n s t i t u t i o n s or f o r e n s i c
units in p r i s o n s had l o s t many o f t h e i r c o n s t i t u t i o n a l
r i g h t s and p r i v i l e g e s .
In 1971 and again in 1975, the Supreme Court decided cases in which i t
declared
that the d i a g n o s i s o f mental i l l n e s s alone does not c o n s t i t u t i o n a l l y j u s t i f y the
deprivation of a p e r s o n ' s physical l i b e r t y .
5
Further, the Courts have recently
-3-00004
upheld the mental p a t i e n t ' s r i g h t to privacy and the r i g h t to be free of cruel
and unusual punishment.^
P r i o r to these r u l i n g s , the i n d i v i d u a l ' s r i g h t to
freedom of mentation was given precious l i t t l e consideration during e x p e r i mentation or therapy by the p s y c h i a t r i c a u t h o r i t i e s .
I t appears that during the
d i a g n o s t i c process, or perhaps as a r e s u l t of i t , the s a n c t i t y and d i g n i t y of
the i n d i v i d u a l have been defined out of e x i s t e n c e , and the researcher or
technician has been free to move forward with h i s " o b j e c t i f i e d "
subject.
In examining these recent j u d i c i a l d e c i s i o n s , in searching for ways
to protect i n s t i t u t i o n a l i z e d i n d i v i d u a l s , several commentators have hypothesized
extensions o f F i r s t Amendment protection for freedom o f mentation from p s y c h i a t r i c
experimentation.''
The most cogent argument i s that of P r o f e s s o r Shapiro, who
theorized the f o l l o w i n g :
The F i r s t Amendment protects a l l kinds o f communications,
w r i t t e n , verbal, p i c t o r a l , symbolic, whether c o g n i t i v e
o r emotive in nature. Communication involves the t r a n s mission and reception of whatever i s communitated.
Transmission and reception n e c e s s a r i l y involve mentation
on the part o f both the person t r a n s m i t t i n g and the person
receiving.
I t i s impossible to d i s t i n g u i s h in advance
mentation which w i l l be involved in or necessary to
transmission and reception from mentation which w i l l not.
I f communication i s to be protected, a l l mentation must
therefore be protected. Organic therapy and experimentation i n t r u s i v e l y a l t e r s or i n t e r f e r e s with mentation.
The F i r s t Amendment therefore protects persons a g a i n s t
enforced a l t e r a t i o n or interference with their„mentation
by coerced organic therapy or experimentation.
A s i m i l a r extension of the F i r s t Amendment was used by the Court in Kaimowitz v.
Department of Mental Health wherein i t enjoined the use o f psychosurgical
experimentation,
Q
stating:
There i s no freedom without choice and there i s no choice
without knowledge--or none that i s not i l l u s o r y .
Implicit,
4<M)©05
therefore, in the very notion o f l i b e r t y i s the l i b e r t y
of the mine! to absorb and to beget . . . For, i f the F i r s t
Amendment protects the freedom to express i d e a s , i t
n e c e s s a r i l y follows that i t must protect the freedom to
generate ideas. Without the l a t t e r , the former i s meaning1 ess J O
Another commentator has taken t h i s one step further with h i s idea that
the fundamental r i g h t of freedom of mentation c o n s t i t u t e s a portion of the
F i r s t Amendment's " n u c l e u s " , and that t h i s n u c l e i c concept i s that the i n d i v i d u a l
himself i s i n v i o l a b l e . ^
This concept of s a n c t i t y of the individual has been
employed in the past as a r a t i o n a l e by the Supreme Court in i t s recognition o f
the fundamental r i g h t of p r i v a c y . 1 2
Lower Courts too have expanded the r i g h t
of privacy to the " r i g h t to be l e f t alone."
A C a l i f o r n i a Court defined the r i g h t
as " a fundamental and compelling i n t e r e s t . . . which protects our homes, our
f a m i l i e s , our thoughts, our emotions, our e x p r e s s i o n s , our p e r s o n a l i t i e s
. . .
An i n d i v i d u a l ' s i n v i o l a b i l i t y from p s y c h i a t r i c experimentation i s a fundamental
i n t e r e s t which may not be abridged for s o c i e t y ' s b e n e f i t , at l e a s t not without
some compelling, o v e r r i d i n g
interest.
One s o c i e t a l i n t e r e s t or benefit frequently a r t i c u l a t e d as the
rationale behind p s y c h i a t r i c experimentation i s that o f the desire for knowledge-a desire to add to s c i e n c e ' s understanding of the nature and function of the brain
and p e r s o n a l i t y .
In t h i s area of p s y c h i a t r i c research, there appear to be no
adequate animal models f o r mental i l l n e s s .
Therefore proponents argue that
continued experimentation on man i s necessary i f science i s ever to learn the
e t i o l o g y of mental i l l n e s s so as to formulate proper treatment.
Under t h i s
same philosophy, "normal" volunteers could not be used f o r t h i s type o f research
as a diseased organism i s needed; thus the prime research subject i s the one
- 00006
expediently l a b e l l e d and i n s t i t u t i o n a l i z e d .
A s u f f i c i e n t l y compelling state i n t e r e s t f o r imposing organic
therapy and experimentation might be advanced under the parens patriae power of
the state.
The state might argue, perhaps s u c c e s s f u l l y in some cases, that
organic therapy and experimentation w i l l enhance the i n d i v i d u a l ' s autonomy by
r e s t o r i n g him to s a n i t y , "making him w e l l . "
Still
under the parens patriae
rationale and u t i l i t a r i a n arguments, the state might argue i t s duty to protect
society in general from disordered i n d i v i d u a l s .
Thus i f organic methods of
treatment can be developed and tested and administered to that end, the s t a t e s '
compelling i n t e r e s t s w i l l have been served.
there are proponents o f organic technological
I t i s no matter o f small concern that
methods of behavioral control :
Psychosurgery, psychopharmacology, e l e c t r o - c o n v u l s i v e shock treatment and
behavior modification who view these methods as a means of curing not only the
" s i c k " i n d i v i d u a l , but on a l a r g e r s c a l e , the " s i c k " s o c i e t y . ^
These proponents
are very much aware of the violence and i t s physical and psychological
pervasive in s o c i e t y .
product
harm
They allege that much of the violence exhibited i s the
of b r a i n s which are functioning abnormally; and that very often v i o l e n t
people are mentally i l l J ^
I t i s the desire of these researchers to use organic
techniques, which w i l l be discussed at length i n the next s e c t i o n , for s o c i a l
control purposes; thereby a s s i s t i n g the state in i t s goal to protect i t s
from violence.
citizens
This w r i t e r has a d i f f i c u l t time with t h i s explanation of
violence and t h i s remedy as science has yet to accurately map the functions of the
brand and to show t h e i r d i r e c t causal r e l a t i o n s h i p to emotion and behavior.
Much
research has been done on the limbic system as the speculated seat of emotion,
-6- 00007
but the inconclusiveness of the r e s u l t s would seem to leave one with strong
doubts as to the prudence of general a p p l i c a t i o n in the area of violence c o n t r o l .
One does not have to venture far into h i s imagination to extrapolate dire
consequences from t h i s approach.
To what extent are the state and i t s employees
in mental i n s t i t u t i o n s going to be allowed to v i o l a t e the i n d i v i d u a l f o r the
greater s o c i a l
good?
This same concern was voiced by the Senate committee on the J u d i c i a r y
in a segment of i t s report, e n t i t l e d " I n d i v i d u a l Rights and the Federal Role in
Behavior M o d i f i c a t i o n " :
To my mind the most serious threat posed by the
technology of behavior modification i s the power t h i s
technology gives one man to impose h i s views and values
on another. In our democratic s o c i e t y values such as
p o l i t i c a l and r e l i g i o u s preferences are expressly l e f t
to i n d i v i d u a l choice.
I f our society i s to remain free,
one man must not be empowered to change another man's
p e r s o n a l i t y and dictate the values, thoughts and f e e l i n g s
of another.
To begin w i t h , there i s the quest to advance
s c i e n t i f i c knowledge through experimentation which must be
reconciled with our s o c i e t y ' s b e l i e f in the I n v i o l a b i l i t y
of a p e r s o n ' s mind and body. Moreover, t h i s personal
autonomy must be reconciled with the need in c e r t a i n
circumstances f o r the state to r e s t r i c t the i n d i v i d u a l ' s
choice concerning experimental medical procedures in order
to enhance or protect h i s autonomy and welfare.
The problem o f ethical experimentation i s the product of
the unresolved c o n f l i c t between two s t r o n g l y held values:
The d i g n i t y and i n t e g r i t y of the i n d i v i d u a l , and the freedom
of s c i e n t i f i c i n q u i r y . P r o f e s s i o n a l s of many d i s c i p l i n e s ,
and researchers e s p e c i a l l y , exercise unexamined d i s c r e t i o n
to i n t e r f e r e in the l i v e s of t h e i r subjects f o r the sake
o f s c i e n t i f i c progress. Although exposure to needless harm
and neglect of the duty to obtain the s u b j e c t ' s consent
have been generally frowned upon in theory, the i n f l i c t i o n
o f unnecessary harm and infringements on informed consent are
frequently accepted in practice as the price to be paid for
the advancement of knowledge. How have i n v e s t i g a t o r s come to
claim t h i s sweeping p r e r o g a t i v e ? ' "
Hopefully, the following d i s c u s s i o n w i l l begin to approach an answer to t h i s
question.
Ill
TREATMENT V. EXPERIMENT
When organic procedures such as psychosurgery, c o n v u l s i o n , psychopharmacology and behavior modification are used to change an i n d i v i d u a l ' s
behavior, they are experimental procedures.
The fine l i n e , i f one ever
e x i s t e d , between treatment and experimentation i s v i r t u a l l y
in p s y c h i a t r i c research where organic procedures are used.
indistinguishable
The t e r r i b l y
serious
and unpredictable e f f e c t s and the p o s s i b i l i t y o f s u b s t a n t i a l harm from the use o f
these procedures require that they continue to be categorized as experimental
when they are used regardless of whether the purpose in the p a r t i c u l a r s i t u a t i o n
i s to "cure" a mental i l l n e s s or to increase the understanding of brain f u n c t i o n ,
or both.
To designate a procedure as treatment c a l l s for a determination o f
improvement and benefit in the person receiving the "treatment".
Both evalua-
tions are extremely subjective in t h e i r nature and are u s u a l l y arrived at by
the i n d i v i d u a l who administered the technique, and are there s u s p e c t . ^
One
commentator has put forth the following c r i t e r i o n for determining the experimental
or non-experimental nature of a p a r t i c u l a r procedure:
Whether or not there has been s u f f i c i e n t evidence and
research to show that the r a t i o of benefits to r i s k s i s
s u f f i c i e n t l y w e l l - e s t a b l i s h e d that the prospective subject
has enough information to assess the predicted outcome
within reasonable l i m i t s .
I f there has not been enough
research, or i f research has shown that the p o s s i b l e benef i t s are not very high compared to the r i s k s , or i f the
r e s u l t s of research are too i n c o n c l u s i v e to estimate the
outcome within reasonable l i m i t s , then we would characterize
the procedure as e x p e r i m e n t a l . ' "
00009
Generally, the d i s t i n c t i o n between treatment and experiment i s important when
there i s a question o f consent.
Under the various c o d e s
experimentation cannot
be done on an i n d i v i d u a l without h i s v o l u n t a r i l y given informed consent, based on
full disclosure.
I f the procedure i s c l a s s i f i e d as experimental e i t h e r because
there are s u b s t a n t i a l
r i s k s in an otherwise routine therapeutic procedure, or i t
i s a novel procedure, the duty to d i s c l o s e i s unquestionably absolute.
no such protection i f the procedure i s denominated as treatment.
There i s
Under the
treatment r a t i o n a l e , the doctor has more d i s c r e t i o n as to the extent of information d i s c l o s e d .
I f he determines that the impact of f u l l
d i s c l o s u r e w i l l have a
deleterious e f f e c t upon h i s patient, he may withhold i t ; h i s duty of f u l l
d i s c l o s u r e in t h i s context i s not a b s o l u t e . ^
Further, i f the procedure i s
routine and d i r e c t l y for the benefit of the p a t i e n t , only minimum d i s c l o s u r e
required.^
is
One can q u i c k l y see that there i s a grave danger in perpetuating
t h i s c l a s s i f i c a t i o n of procedures as e i t h e r therapeutic or experimental in the
p s y c h i a t r i c realm.
I f one c l a s s i f i e s the procedure as therapeutic, the i n d i v i d u a l
i s without a means to exercise control over h i s body and mind.
He is no longer
a partner, at l e a s t in theory, in the decision-making process.
In Knecht v.
GilIman, i n s t i t u t i o n a l
doctors administered apomorphine i n j e c t i o n s as part of an
aversion therapy program to an individual without h i s consent.
The doctors
t e s t i f i e d that they did not feel compelled to obtain consent as the h o s p i t a l
a u t h o r i t i e s had c l a s s i f i e d the drug as " t h e r a p y " . ^
The substantial
risks
inheren
in the use o f t h i s drug, in p a r t i c u l a r c a r d i o - v a s c u l a r r e a c t i o n s , removes i t to
the experimental category.
Any meaningful c a t e g o r i z a t i o n , therapeutic or
experimental, or organic procedures would seem impossible in the p s y c h i a t r i c
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setting.
At best i t would be an a r t i f i c i a l
c l a s s i f i c a t i o n which would be
a r b i t r a r i l y used by i n s t i t u t i o n a l personnel to f a c i l i t a t e t h e i r attempts at
behavioral c o n t r o l .
Thus due to a l l of the r i s k s involved, t h i s
w r i t e r approaches
the use of the following organic procedures as experimental whenever they are
used on human beings.
Such c l a s s i f i c a t i o n requires s t r i c t e r standards and more
c r i t i c a l s c r u t i n y of the procedures so as to protect the i n d i v i d u a l .
IV
ORGANIC MODALITIES
A.
Psychopharmacology
Psychopharmacology i s a r e l a t i v e l y new f i e l d which has developed
quite rapidly during the l a s t two decades.
The compounds produced by the drug
industry f o r p s y c h i a t r i c use have f a l l e n into f i v e basic categories.
The f i r s t
group i s made up of stimulants which increase wakefulness and decrease f a t i g u e ;
the strongest side e f f e c t s are seen in the central nervous and c a r d i o - v a s c u l a r
systems.^
The second group i s that o f the a n t i - d e p r e s s a n t s - - t h e monoamine
oxidase i n h i b i t o r s used to a l l e v i a t e depression by i n c r e a s i n g the e l e c t r i c a l
a c t i v i t y in the brain by i n c r e a s i n g the quantity of chemicals in the synapses
between nerve f i b e r s .
The more chemical t r a n s m i t t e r s present, the more nerve
24
impulses or s i g n a l s that can be transmitted to the brain.
The p a r t i c u l a r
e f f i c i e n c y of these drugs has never been e s t a b l i s h e d - - a fact which keeps them
in the experimental
realm.
Reports on patients showing improvement vary from
t h i r t y to eighty percent depending on the r e s e a r c h e r s ' choice of c r i t e r i a
for
diagnosis and improvement. 25 P o s s i b l e side e f f e c t s include insomnia, b l 26
urred
v i s i o n , and t o x i c e f f e c t s on the b r a i n , l i v e r and cardiovascular system.
-10-
00011
Phenothiazine d e r i v a t i v e s , t r a n q u i l i z e r s , make up the t h i r d group.
are most often used to treat schizophrenic reactions and anxiety.
Phenothiazines
Significant
b e n e f i c i a l e f f e c t s have been reported for the use o f these drugs, but they too
can have devastating side e f f e c t s :
dyskinesia.^
Convulsions, Parkinsonism, and tardive
The fourth group i s made up of the milder tranqui 1 i z e r s and seda-
t i v e s which are used to r e l i e v e neurotic anxiety and create a sense o f w e l l - b e i n g . 2 ^
Side e f f e c t s from this group appear as problems in drug dependence and i n h i b i t i o n
of i n i t i a t i v e with a decrease in v i g o r . ^
The four groups above are employed
as mood changers; and are most often used in s i t u a t i o n s where modification o f
behavior i s being sought.
The f i f t h group of psychoactive drugs i s used to
30
produce t r a n s i e n t psychotic s t a t e s .
These are the ones most widely used in
s i t u a t i o n s where researchers acknowledge experimentation.
Some o f these drugs
l i k e mescaline and p s i l o c y b i n are found in native p l a n t s ; others l i k e LSD-25
are s y n t h e t i c . ^ 1
The widespread use of the drugs often leads to t h e i r acceptance
as safe procedures, but one has only to consider the s e r i o u s r i s k s and the lack
of published data on t h e i r l a s t i n g e f f e c t s , i n c l u d i n g f l a s h backs, to move away
from t h i s p o s i t i o n o f acceptance.
In an attempt to ameliorate the genuine concerns about the r i s k s ,
proponents f o r neuropsychopharmacologic research argue the s i g n i f i c a n t
t i o n s which i t has made to the welfare of mankind.
contribu-
They point to the discovery
and development of new drugs which have allowed persons diagnosed as32 severely
psychotic to be d e i n s t i t u t i o n a l i z e d and returned to t h e i r f a m i l i e s .
One faction
of proponents, the American College of Neuropsychopharmacology, has set out a
statement o f p r i n c i p l e s which i s designed to protect the welfare of each research
00012
subject—whether in a c l i n i c a l
the p r i n c i p l e s developed w i l l
or n o n - c l i n i c a l
fill
setting.
I t i s t h e i r hope that
the gap which they perceive has been l e f t by
the legal considerations and governmental regulation in t h i s area.
The p r i n c i p l e s
are framed so that the researcher knows what he may or may not do in an e x p e r i mental s i t u a t i o n i n v o l v i n g drugs in order to assure that ethical requirements are
met.33
Researchers have not always been so concerned with the welfare of
t h e i r subjects.
Some e a r l y studies attempting to evaluate the effectiveness o f
psychotropic drugs, employed the double-blind technique where patients given
psychotropic drugs were compared with patients s i m i l a r l y diagnosed, but given
34
placebos without t h e i r knowledge.
l e p t i c s and placebos.
S i m i l a r s t u d i e s have been done using neuro-
The withholding of a drug with known therapeutic e f f e c t and
administering a placebo in i t s stead must s u r e l y be unethical even i f one adds
the b a s i c r a t i o n a l e of s o c i e t a l benefit to the c a l c u l u s .
The i n d i v i d u a l s
in
these studies were not told they were receiving placebos; and t h e i r symptoms
were not a l l e v i a t e d - - a s i t u a t i o n which must have caused much fear and f r u s t r a t i o n
for i n d i v i d u a l s who were involved in "therapy" which was supposed to make them
better.
In a s i m i l a r study, psychotic patients who were being maintained with
phenathiazine and released back into the community were taken o f f the drug
without t h e i r knowledge and consent.
Seventy-three percent experienced a relapse
of severe symptoms and had to be readmitted to the h o s p i t a l . 3 5
i n v o l v e s an i n d i v i d u a l
Another study
diagnosed as acutely p s y c h o t i c , who was i n v o l u n t a r i l y
committed and immediately placed in a control group for drug research; no consent
was given.
She was given no drug treatment, only placebos.
-12-
She was not dangerous
yet she had been deprived o f her l i b e r t y under the s t a t e ' s p a t e r n a l i s t i c
rationale
oC
of providing
"treatment".
In a s e r i e s of d e c i s i o n s , the J u d i c i a r y has turned i t s attention to such
research p r a c t i c e s .
The most well-known case i s perhaps Wyatt v. Stickney37
which held that:
Patients s h a l l have a r i g h t not to be subjected to e x p e r i mental research without the express and informed consent
o f the p a t i e n t , i f the patient i s unable to give such
consent, and h i s guardian or next of k i n , a f t e r opportunities
f o r c o n s u l t a t i o n with independent s p e c i a l i s t s and with
legal counsel. Such proposed research s h a l l f i r s t have been
reviewed and approved by the i n s t i t u t i o n ' s Human Rights
Committee before such consent s h a l l be sought. P r i o r to
such approval, the Committee s h a l l determine that such
research complies with the p r i n c i p l e s o f the Statement on
the Use of Human Subjects f o r Research of the American
A s s o c i a t i o n on Mental Deficiency and with the p r i n c i p l e s
f o r research i n v o l v i n g human subjects required by the U.S.
Department of Health, Education and Welfare for projects
supported by that a g e n c y . 3 8
This decision i s very s i g n i f i c a n t as i t set up the requirements for consent
procedures i n c l u d i n g the requirement f o r legal counsel.
reach the c o n s t i t u t i o n a l
implications.
Yet t h i s Court did not
This same y e a r , 1973, the Ninth C i r c u i t
did consider the i n d i v i d u a l ' s c o n s t i t u t i o n a l
r i g h t s under the Eighth Amendment.
The p l a i n t i f f was a state prisoner who consented to undergo shock treatment in a
state mental f a c i l i t y where p s y c h i a t r i c experimentation was ongoing in a v e r s i v e
behavior modification of criminal offenders.
Without h i s consent, the p l a i n t i f f
was given s u c c i n y c h o l i n e - - a drug which produces a gross f r i g h t reaction.
This
drug i s normally used as an adjunct to e l e c t r o - c o n v u l s i v e shock to relax the
i n d i v i d u a l so as to minimize the p o s s i b i l i t y of f r a c t u r e s .
I t should not be
given by i t s e l f to a f u l l y conscious i n d i v i d u a l due to the f r i g h t e n i n g
14
results--
severe breathing d i f f i c u l t y with sensations of drowning.
that the p l a i n t i f f ' s
The appellate Court held
r i g h t to be free o f cruel and unusual punishment had been
v i o l a t e d and that the f o r c i b l e i n j e c t i o n o f the experimental drug constituted
an impermissible t i n k e r i n g with the i n d i v i d u a l ' s mental processes.^ 0
I t was not
u n t i l the Kaimowitz d e c i s i o n , to be discussed more f u l l y in the section on
psychosurgery, that the Courts looked to the F i r s t Amendment f o r c o n s t i t u t i o n a l
protection of the mental
processes.^ 1
There i s l i t t l e doubt that psychoactive drugs do achieve benefits
for
the i n d i v i d u a l ; patients who have appeared unreachable in t h e i r bouts with
schizophrenia or immobilized by depression or t e r r i f i e d by anxiety have found t h e i r
way back to a more meaningful existence through the use of t h i s organic procedure.
Yet underlying these b e n e f i t s , there are ethical
i s s u e s which must be addressed.
One of the primary considerations with the research in psychoactive chemicals
the lack of knowledge of the i n d i v i d u a l ' s
reactions to them; a careful
is
assessment
of the r a t i o between the benefits and the r i s k s needs to be made so that no
further harm comes to a s u f f e r i n g i n d i v i d u a l who has been diagnosed as mentally
ill
and committed to an i n s t i t u t i o n .
This assessment c a l l s f o r an estimation of
the e f f e c t i v e n e s s and an accounting of the incidence and seriousness of s i d e
effects.
Very l i t t l e has been published in t h i s area.
Perhaps a more insideous
harm which some may consider a benefit i s the element of chemical management of
human beings.
The use of r i t a l i n to control a c h i l d diagnosed as hyperactive
has been both p r a i s e d and damned depending on the point of view of the evaluator.
As a former teacher in the public school systems, t h i s w r i t e r has t r i e d to work
with children who have been so narcotized by r i t a l i n that they were unreachable.
-14-
000.15
She preferred using the m u ] t i - s e n s o r i a l
approach to reach and teach a c h i l d
l a b e l l e d " h y p e r a c t i v e " ; with t h i s approach, the c h i l d was not further handicapped
in h i s learning by the i n t r u s i v e d u l l i n g effect of drugs.
The term "ware-
housing" has come to be applied to the regime o f chemical control o f many
mental i n s t i t u t i o n s in the l a s t decade where d a i l y doses of thorazine and l i k e
substances are used to "manage" human beings.
This w r i t e r has some d i f f i c u l t y
seeing these as benefits to j u s t i f y psychopharmacologic research.
The research
subject in such a s i t u a t i o n does not seem to be the one who b e n e f i t s .
A second ethical concern centers around the use of
persons as subjects for research.
institutionalized
There are those who argue that i t i s
permissible
to use i n s t i t u t i o n a l i z e d subjects i f they are to benefit i n d i v i d u a l l y from the
research.
But then t h i s harkens back to the thought that one man's benefit may
4?
be another man's harm.
disadvantage.
The i n s t i t u t i o n a l i z e d i n d i v i d u a l
i s at a d e f i n i t e
A1ready much of h i s autonomy has been taken from him; decisions
about h i s well-being are being made by s t r a n g e r s .
He may be caught up in the
coercive power p o s i t i o n i n g which the hospital atmosphere creates and perpetuates.
The ethical
i s s u e s i n v o l v i n g informed consent and the
institutionalized
i n d i v i d u a l , g e n e r a l l y , w i l l be dealt with at the end of t h i s section on organic
procedures, but the related i s s u e of incomplete d i s c l o s u r e w i l l be addressed
in t h i s s e c t i o n .
Some research designs require l e s s than f u l l
disclosure—those
employing the use of placebos or those in which the i n d i v i d u a l s have v i o l a t i l e
mental s t a t e s .
Professional
codes generally give doctors the therapeutic
p r i v i l e g e to withhold information that they deem harmful to the patient as in the
s i t u a t i o n with research of the effects o f a drug on a paranoid individual
00016
which
i s to be recorded and analyzed by o b s e r v e r s . ^ 3
I t would seem that at the very
minimum, the person, before making h i s decision to p a r t i c i p a t e , should be t o l d
that information i s being withheld; he can then decide whether to p a r t i c i p a t e
on that b a s i s .
Another related i s s u e concerns the r i g h t to withdraw from the e x p e r i ment.
Once a psychoactive drug has been induced, the i n d i v i d u a l may not be able
to express h i s desire to withdraw o r the drug e f f e c t s may not be e a s i l y counteracted or they may have addictive p r o p e r t i e s . ^
I t would seem that the researcher
has a duty to respect the self-determination of the i n d i v i d u a l and to inform him
o f these contingencies and d i s c u s s h i s desires before the experiment begins.
The f i n a l i s s u e concerns what c r i t e r i a are to be used to assess the
success of the psychopharmaceutical research.
Or the r e l a t i v e concept of normal?
The r e l a t i v e concept of b e n e f i t ?
These are nothing more than value determina-
tions which seem to form the bedrock of mental i l l n e s s and/or mental health and
neither i s very helpful in f i n d i n g answers to these ethical
B.
questions.
Psychosurgery
Psychosurgery i s the second organic procedure which must s t i l l be
considered experimental regardless o f the purpose alleged in the p a r t i c u l a r
setting.
Psychosurgery i s the s u r g i c a l
removal or destruction of brain t i s s u e
or the c u t t i n g of brain t i s s u e to disconnect one part of the brain from another,
which i s performed with the purpose of a l t e r i n g behavior or emotional
status
when there i s no d i r e c t evidence of e i t h e r s t r u c t u r a l damage in the brain or
organic brain d i s e a s e . ^ 5
Surgeons performing such procedures do so under the
presumption that there are physical phenomena occuring in the brain which produce
-21-
00017
aberrant behavior such as depression, a g i t a t i o n , compulsion, d e l u s i o n , h a l l u c i n a t i o n , or v i o l e n c e . ^
T h e o r e t i c a l l y , such surgery i s performed only as a l a s t
r e s o r t a f t e r other forms of therapy, t a l k i n g , drug and e l e c t r o c o n v u l s i v e shock
have f a i l e d to r e l i e v e the exhibited symptoms.
H i s t o r i c a l l y , the brain and
behavior c o r r e l a t i o n s were f i r s t i d e n t i f i e d some twenty-five centuries ago i n
s i t u a t i o n s where doctors noted the behavioral e f f e c t s of brain wounds and the
onset of e p i l e p t i c s e i z u r e s in patients wounded in b a t t l e . D u r i n g
the
Eighteenth and Nineteenth Centuries men of science attempted to map the b r a i n
and i t s function and dysfunction, f i r s t in animals, l a t e r in human beings
designated as having cerebral d i s e a s e s . 4 8
In 1935, the Portuguese n e u r o l o g i s t ,
Egas Moniz, was the f i r s t to attempt to r e l i e v e mental i l l n e s s by s u r g i c a l
p r o c e d u r e s B a s e d on research r e s u l t s on s i m i l a r procedures with monkeys,
he performed s e c t i o n i n g procedures to separate the subcortical connections from
the frontal
lobes, f i r s t by using alcohol i n j e c t i o n s , l a t e r by
scalpel.Over
the next decade, numerous procedures were performed and favorable r e s u l t s were
CI
reported.
This procedure did not impact h e a v i l y on p s y c h i a t r i c research and
treatment in t h i s country until the mid-1950's when some 50,000 operations were
CO
reported y e a r l y .
With the advent o f a new t r a n s o r b i t a l
technique, i t was no
longer necessary to s u r g i c a l l y open the s k u l l ; i n s t e a d , by using a s p e c i a l l y
designated instrument, i n s e r t e d through the eye socket, the researcher with quick
t h r u s t i n g motions could sever the c o r t i c a l
connections.53
l a b e l l e d the " i c e pick" method by c r i t i c s . 5 4
This technique has been
This procedure provided f o r a l e s s
radical destruction of the frontal lobe connections and surrounding t i s s u e .
I n t e n s i v e s t u d i e s to assess the therapeutic e f f e c t of the procedure were done,
-17-
00038
but long a f t e r the procedures had become commonplace occurrences in mental
institutions.
The procedures were deemed successful as they reduced unpleasant
behavior in i n d i v i d u a l s ; the fact that the underlying thought disorders
to e x i s t and that there was apparently considerable l o s s of higher
continued
sensitivities
55
was not considered s i g n i f i c a n t .
In the late 1 9 5 0 ' s , there was a decline in
the number of psychosurgical procedures, perhaps due to the increase in the use
of drugs to modify b e h a v i o r . ^
In the l a s t decade, there appears to be a renewed i n t e r e s t in psychosurgery due to the developments in e l e c t r o n i c technology.
Stereotaxic psycho-
s u r g i c a l techniques have given researchers a c c e s s i b i l i t y to the h i g h l y d i f f e r e n t i a t e d deep s t r u c t u r e s of the b r a i n .
This technique was developed to minimize
the amount of gross destruction o f brain t i s s u e s which occurred with the t r a d i t i o n a l
lobotomies. Using the three-dimensional geometric coordinates and Xr--yr a y ,
researchers are able to s u r g i c a l l y p o s i t i o n electrodes in the brain.
The
electrodes carry a weak current to the p a r t i c u l a r s i t e to be stimulated.
CO
I f the s i t e i s to be destroyed, a very strong current i s conducted to the s i t e by
59
wires and the t i s s u e i s ablated.
This technique i s now being used to reach
the limbic system within the brain beneath the neo-cortex.
I t i s thought that
the limbic system i s the b a s i s of the e n t i r e range of a f f e c t i v e
emotions.^
I t i s claimed that s t i m u l a t i o n of implanted electrodes may induce physical movemen
create aggression or pleasure, change sexual behavior, influence and a f f e c t
memory and the mentation process i t s e l f . 6 1
Research based on experimentation
in t h i s area has produced a t r a n s i s t o r i z e d device known as the stemoceiver.^2
Lesions are made in a p a r t i c u l a r part of the limbic system, u s u a l l y the amygdala,
-21-
00019
and a capsule i s implanted in the t i s s u e .
The capsule contains a receiver to
detect radio s i g n a l s which are converted to e l e c t r i c a l
current to stimulate the
brain and a recorder-transmitter to gather and transmit information from the
implanted e l e c t r o d e s . 5 3
a s t a t i o n a r y device outside the i n d i v i d u a l ' s body i s
rfi
used to send and receive information.
The device allows the researcher to
stimulate the brain of an unaware subject from a remote distance on a continuing
basis.65
What p r i c e — t h i s new knowledge brought about by advances in psychosurgery?
The great weight of evidence seems to point out that surgery on the
limbic system produces marked d e t e r i o r a t i o n in behavior,
severe impairment in
rr
mentation and d i s a s t r o u s s o c i a l adjustment e f f e c t s .
Physiological
effects
may include post operative grand mal s e i z u r e s , blindness and death. 5 ' 7
Consequently, one must not lose s i g h t of the fact that this remains a d r a s t i c ,
h i g h l y experimental procedure in s p i t e of the thousands of procedures which have
been performed.
Due to these dire considerations and the sparse documentation
of b e n e f i t , i t would seem that psychosurgery should not be allowed to be performed
on i n s t i t u t i o n a l i z e d
individuals.
There i s very l i t t l e case law in t h i s area; Kaimowitz v. Department
o f Mental H e a l t h 5 8 appears to be the f i r s t j u d i c i a l
response on the question o f
an i n s t i t u t i o n a l i z e d i n d i v i d u a l ' s r i g h t s to be free of psychosurgical
i n t o h i s brain.
intervention
The state l e g i s l a t u r e in Michigan had a l l o c a t e d funds for a
research program, the purpose of which was to i n v e s t i g a t e the r e s u l t s of medical
treatment versus s u r g i c a l treatment of i n d i v i d u a l s committed to the state hospital
for the c r i m i n a l l y insane because of t h e i r severe uncontrollable violent behavior. 1
John Doe was among those chosen for psychosurgical procedures c a l l e d e l e c t r o dephography, designed to t e s t e l e c t r i c a l s t i m u l a t i o n of the c o r t i c a l
areas.70
The protocol for t h i s procedure required Doe's informed voluntary consent and a
review committed to evaluate h i s s u i t a b i l i t y f o r the procedure. 7 1
parents signed the consent f o r m s . 7 2
Michigan Legal Services attorney
Doe and h i s
A few days before the scheduled s u r g e r y ,
Gabe Kaimowitz sued to enjoin the experiment.
73
Doe was freed under a habeas corpus p e t i t i o n a l l e g i n g that the Michigan criminal
psychopath statute denied him equal protection under the law and was therefore
unconstitutional.7^
The Court in a broad protective decision held that patients
i n v o l u n t a r i l y committed in state i n s t i t u t i o n s are l e g a l l y incapable of g i v i n g
competent, voluntary, knowledgeable consent to experimental operations which w i l l
i r r e v e r s i b l y destroy brain t i s s u e . 7 5
I t also declared that the F i r s t Amendment
freedoms of speech and expression presuppose a r i g h t to generate ideas which
7 fi
could be destroyed or impaired by psychosurgery, / D and that the cotistitutional
r i g h t to privacy would be f r u s t r a t e d by unwarranted medical i n t r u s i o n into the
77
patient's
brain.
As mentioned in the beginning section o f t h i s paper, t h i s decision
apparently created a new r i g h t to t h i n k - - t o beget ideas under the F i r s t
Amendment.
Therefore, i t was incumbent upon the state to show some compelling
i n t e r e s t to v i o l a t e such a r i g h t .
behavior was not s u f f i c i e n t .
I r r e v e r s i b l e modification of an i n d i v i d u a l ' s
The Court also seemed to recognize that although
the control of violence would be a great benefit to s o c i e t y , i t would not outweigh
the invasion into the i n t e g r i t y of the mind protected by the r i g h t to p r i v a c y .
V i o l a t i n g the i n t e g r i t y of an i n d i v i d u a l ' s mind i s too great a price to pay for
00021
s o c i e t a l control of aggression.
The ethical questions to be explored with psychosurgery are s i m i l a r
to those raised with the use o f psychoactive drugs.
To begin, one must consider
the question of whether the benefits outweigh the r i s k s involved.
of psychosurgery i s in s e r i o u s question.
The e f f i c a c y
There have been few systematic
comparative s t u d i e s undertaken to determine whether psychosurgery i s e f f e c t i v e in
70
a l l e v i a t i n g alleged mental i l l n e s s .
Psychosurgery focuses only on the emotional
or behavioral aspect of the i n d i v i d u a l ' s i l l n e s s ; i t does not affect the underlying
symptoms.
They are merely masked as affect i s flattened.
There are s u b s t a n t i a l
r i s k s involved which go to the core of the i n d i v i d u a l ' s i n t e g r i t y and threaten
both h i s physical and mental autonomy.
The cost of e l i m i n a t i n g deviant behavior
may be the l o s s o f the range of emotions which makes l i f e meaningful to the
individual.
As an i n d i v i d u a l
consideration, when the decision i s made to use
t h i s procedure, i t i s u s u a l l y as a l a s t r e s o r t ; one wonders whether the person
g i v i n g consent, be i t the i n d i v i d u a l himself or a t h i r d party, can make a v a l i d
decision under the circumstances where the i n d i v i d u a l may be considered already
"beyond h e l p " .
The i n d i v i d u a l must be f e e l i n g enormous d e s p a i r , fear and f r u s t r a -
tion as a l l other procedures have been used and s t i l l h i s behavior i s too
aberrant to be acceptable to those in a u t h o r i t y .
The f a m i l y , i f involved, may
be experiencing some o f the same emotions and are prepared to t r y such a d r a s t i c
procedure to change the i n d i v i d u a l ' s behavior.
The d i s t i n c t i o n s between thera-
peutic and experimental, i f there are any, fade q u i c k l y in the " l a s t r e s o r t "
s i t u a t i o n l i k e t h i s , and i n d i v i d u a l s are w i l l i n g to r i s k the chances.
A related ethical i s s u e i s seen in the profound practical problem of
-21-
00022
diagnosis or l a b e l l i n g patients f o r psychosurgical
treatment.
The researcher
must d i s t i n g u i s h between the i n d i v i d u a l ' s i l l n e s s and what c o n s t i t u t e s normal
behavior.
I s the researcher to pick a norm, a model o f h i s own choosing?
Again the a r b i t r a r i n e s s of value judgment must be considered.
Perhaps the most s i g n i f i c a n t ethical
i s s u e outside that of consent
which s h a l l be discussed l a t e r i s the issue of behavior c o n t r o l , p i t t i n g the
public or s o c i e t a l
i n t e r e s t s against the private i n t e r e s t s of the i n d i v i d u a l .
Interference with the process of mentation undermines the widely accepted b e l i e f
in the i n v i o l a b i l i t y of the b r a i n .
I f the purpose i s to modify the mind, i s
science creating a new person by changing the mentation process?
I s psycho-
surgery c o r r e c t i n g a defect or a l t e r i n g a s t r u c t u r e which has i n t e g r i t y by v i r t u e
of i t s very existence which must be respected?
argue that t h e i r new techniques w i l l
Some proponents of psychosurgery
alleviate individual suffering.
Others
hope to see t h i s procedure as a mechanism to cure some of s o c i e t y ' s i l l s , more
s p e c i f i c a l l y to modify i n d i v i d u a l behavior so as to control violence.
There i s no
doubt that violence and aggression create a great harm in s o c i e t y which may
create a precarious balance between i n d i v i d u a l freedom and i n d i v i d u a l and s o c i e t a l
security.
One fears there may be a time when there w i l l be a societal
to provide s e c u r i t y at the expense of i n d i v i d u a l
freedom o f mentation.
willingness
Psycho-
surgery could very e a s i l y be the mechanism necessary to accomplish t h i s end.
Mark
and E r v i n , i n t h e i r book, Violence and the B r a i n , speculate that much of the
79
violence in s o c i e t y i s the r e s u l t of abnormally functioning b r a i n s .
theorize that by experimentally implanting electrodes in v i o l e n t
They
individuals,
a researcher could e s t a b l i s h a violence t h r e s h o l d , and a treatment program using
a stemoceiver could be developed to control a g g r e s s i v e behavior before i t i s
exhibited.Visions
of the worlds of Z a m i a t i n ' s We, Burgess' A Clockwork
Orange, and C h r i c h t o n ' s Terminal Man loom as dark shadows over t h i s
A related ethical
social control.
consideration.
issue concerns the use o f psychosurgery f o r general
As mentioned at the beginning of t h i s paper, the p r e v a i l i n g
method for dealing with behavior which deviates from the norm i s the process
of diagnosing or l a b e l l i n g an i n d i v i d u a l
dual i s " s i c k " , he must be treated.
into a disease category.
I f the i n d i v i -
I f the stemoceiver may be used to control
a g g r e s s i v e behavior as seen above, i t may well be applied to other areas such as
alcohol or drug a d d i c t i o n , sexual deviance from the norm . . . d i s s e n t e r s
accepted p o l i t i c a l
ideology?
those in p o s i t i o n s o f power.
from
A l l areas where behavior i s deemed deviant by
The increased power that psychosurgery and e s p e c i a l l y
the use of the stemoceiver device gives some men over others in a society i s a
real threat to be reckoned with.
C.
Behavior M o d i f i c a t i o n
Behavior modification through the use o f aversive therapy and e l e c t r o -
convulsive shock are organic procedures which l i k e psychopharmacology and
psychosurgery must s t i l l
be considered as experimental interference with behavior
due to the unpredictable r i s k s involved.
Aversion therapy has been defined as
an attempt to a s s o c i a t e an undesirable behavior pattern with unpleasant stimuli
l a t i o n or unpleasant physical symptoms.
I t has been used on i n d i v i d u a l s
diag-
nosed into categories of p s y c h o s i s , sexual d i s o r d e r s , drug a d d i c t i o n , and violence.
The e f f i c a c y of t h i s procedure l i k e that of the foregoing has yet to be e s t a b l i s h e d
by c a r e f u l l y c o n t r o l l e d s t u d i e s .
00038
Proponents argue that the value of t h i s procedure
-17-
i s that i t provides a quick and e f f i c i e n t means o f achieving control
03
deviant behavior.
over
Aversive therapy most often involves the use of drugs on an
i n d i v i d u a l when he e x h i b i t s undesired behavior.
t h i s manner i s succinycholine (anectine).
The most popular drug used in
Anectine provides an e a s i l y
quickening fear producing experience during which the i n d i v i d u a l i s
o4
and susceptible to suggestion.
controlled
conscious
One experimental study was done in a state
h o s p i t a l with i n d i v i d u a l s l a b e l l e d mentally disordered sex offenders and those
adjudicated c r i m i n a l l y insane to determine the e f f e c t i v e n e s s of anectine to
modify behavior.® 5
During the experiments when the i n d i v i d u a l ' s
stopped, the t a l k i n g phase o f treatment began.
respiration
P o s i t i v e and negative suggestions
were given while the i n d i v i d u a l was having great d i f f i c u l t y breathing,
including
threats of repeated administration o f anectine for further i n f r a c t i o n s of
institutional
rules.^
Other forms of aversion therapy involve the use o f
drugs administered in connection with aberrant behavior which induce vomiting.
The Courts have c o n s i s t e n t l y i n v a l i d a t e d such experimental procedures under the
F i r s t and Eighth Amendments.
The major ethical consideration here concerns the a u t h o r i t a t i v e
decision maker.
In i d e n t i f y i n g certain behavior as unacceptible, behavior to be
extinguished and in establishing a more acceptible behavior, he i s doing l i t t l e
more than making a moral or s o c i a l
value judgment from which he proceeds to
change the i n d i v i d u a l subject to h i s power.
Another issue involves the lack of
self-determination for i n d i v i d u a l s designated as p a r t i c i p a n t s in such procedures.
D.
Convulsive Procedures
Convulsive procedure i s a term which includes e l e c t r o c o n v u l s i v e shock
00025
and i n s u l i n coma, chemical shock.
The procedure causes the patient to undergo
a seizure of grand mal i n t e n s i t y .
Proponents claim the seizure causes
significant
89
psychological changes in the i n d i v i d u a l .
procedure i s questionable.
Once more the e f f i c a c y of t h i s
Although shock treatment has been widely applied,
doubts about i t s curative powers p e r s i s t .
Some have estimated that ECT i s
eighty percent s u c c e s s f u l in t r e a t i n g severe depression; others rate i t much
lower, and there seems to be l i t t l e r e l a t i o n between shock 90
treatment and the
period of h o s p i t a l i z a t i o n or the disappearance of symptoms.
This makes
consideration o f the r i s k s to the i n d i v i d u a l weigh even more heavily to keep
t h i s procedure in the experimental category.
Side e f f e c t s of ECT include
d i s o r i e n t a t i o n in time and space, psychotic episodes, damaged muscles, damaged
brain t i s s u e , broken bones, and l o s s of memory which may be permanent and s e v e r e . ^
Side e f f e c t s of chemical shock include prolonged comatose states which may be
f a t a l , hypoglycemic r e a c t i o n s , r e s p i r a t o r y problems r e s u l t i n g from a s p i r a t i o n ,
and a l l e r g i c r e a c t i o n s . 9 2
The sheer u n p r e d i c t a b i l i t y of reactions in these
procedures render them h i g h l y experimental.
In the l a s t decade Courts have
begun to recognize the o v e r r i d i n g i n t e r e s t of the i n d i v i d u a l to maintain the
i n t e g r i t y of h i s mind from such gross interference created by shock procedures,
holding that even though an i n d i v i d u a l may have been diagnosed
QQ into a c e r t a i n
category, he s t i l l
has a r i g h t to refuse such an i n t r u s i o n .
One theory f o r using shock, known as depatterning, has as i t s
purpose
the r e g r e s s i o n of the subject to an i n f a n t i l e state in order to restructure h i s
development. 9 4
In one experiment, doctors shocked subjects twice daily
until
depatterning occurred; at that point the i n d i v i d u a l s had been reduced to a state
26
of utter h e l p l e s s n e s s , apathy and confusion, d i s p l a y i n g memory l o s s , speech
95
problems and gross d i s o r i e n t a t i o n .
E t h i c a l l y , one wonders i f the benefits to
the i n d i v i d u a l and/or s o c i e t y from such an exercise of power in an experiment can
p o s s i b l y outweigh the i n d i v i d u a l ' s l o s s of autonomy, i n t e g r i t y and d i g n i t y .
The i n t e g r i t y and privacy of the i n d i v i d u a l
are also v i o l a t e d in many h o s p i t a l s
where the shock treatment i s administered in the view o f other patients as a
96
warning f o r i t s deterrent e f f e c t s on others.
I t i s apparent from the foregoing that through medical
technology
and behavioral research, man has learned how to modify behavior, but he s t i l l
cannot explain why i t i s modified once the procedure i s accomplished.
He does
not know what changes have occurred in the o r g a n i c i t y and function of the b r a i n .
One commentator has analogized t h i s to k i c k i n g a candy machine to make a c e r t a i n
candy bar drop.
I t might be b e t t e r , he surmises, to i n v e s t i g a t e whether the
device receiving the quarters i s bent or the lever for r e l e a s i n g the candy i s
defective rather than continue k i c k i n g the machine, even i f i t does sometimes
97
drop a candy bar a f t e r a kick.
One f e e l s that some elements within the experimental s o c i e t y do not
view the brain any d i f f e r e n t l y from other organs o f the body.
For many, there
appears to be no d i s t i n c t i o n when considering the extremely i n t r u s i v e
interven-
tion o f psychosurgery, drugs or shock on the mind from consideration o f procedures
on the other parts of the body; no special respect i s given to the brain and the
f u n c t i o n i n g e n t i t y of the mind.
This w r i t e r ' s research has born out the idea
that the physical s t r u c t u r e of the brain cannot be altered s u b s t a n t i a l l y without
a f f e c t i n g the i n t e l l e c t and emotions, without changing the i d e n t i t y of the whole
00027
individual.
I t i s necessary to consider the death of some o f the aspects of
mentation or p e r s o n a l i t y in the balancing of a l l of the i n t e r e s t s
involved.
V
INFORMED CONSENT AND THE INSTITUTIONALIZED INDIVIDUAL
Voluntary, informed consent i s the mechanism best able to protect the
i n s t i t u t i o n a l i z e d i n d i v i d u a l ' s autonomy.
The fundamental goal of a working
informed consent standard should be the preservation of the i n d i v i d u a l ' s
to determine what s h a l l be done with h i s own body and mind.
right
For several years
there has been a running c o n f l i c t between the p s y c h i a t r i c and legal
disciplines
regarding the a p p l i c a b i l i t y and usefulness of informed consent as they apply
to i n d i v i d u a l s diagnosed as mentally i l l .
Those from the p s y c h i a t r i c community
consider the establishment requirements overly formal, ambiguous, threatening to
their
{ d o c t o r - r e s e a r c h e r ' s ) i n t e g r i t y , and lacking in understanding of the
nature of severe mental i l l n e s s and i t s effect on the i n d i v i d u a l ' s
decision-making
no
ability.
On the other s i d e , the legal community d e s i r i n g to protect the
i n t e g r i t y of the i n d i v i d u a l
from dehumanizing experiences demands more comprehen-
s i v e doctrines which would increase the use of review committees, determine
both e t h i c a l l y and s c i e n t i f i c a l l y the calculus of r i s k s v. b e n e f i t s , be more
s e l e c t i v e about subjects to be used, and severely c u r t a i l
the p h y s i c i a n -
r e s e a r c h e r ' s r i g h t to withhold information which the subject has a r i g h t to know.H i s t o r i c a l l y and t r a d i t i o n a l l y , the doctrine o f informed consent
presumes that the i n d i v i d u a l
i s a competent adult who a f t e r receiving a f u l l
d i s c l o s u r e about h i s i l l n e s s from h i s doctor, weighs all o f the factors and
then v o l u n t a r i l y and r a t i o n a l l y makes decisions concerning the therapeutic and
00028
experimental procedures.
This i d e a l i s t i c conceptualization runs into some
seemingly insurmountable obstacles when the i n d i v i d u a l has been labelled
mentally i l l , i s i n s t i t u t i o n a l i z e d and the proposed procedure i s considered
experimental.
Under such circumstances there l i e s the very b a s i c question about
the i n d i v i d u a l ' s a b i l i t y to understand and/or v o l u n t a r i l y consent to the procedure.
One o f the f i r s t cases dealing with informed consent to experimental
treatment came from England in 1767. 100
The Court in a f f i r m i n g judgment f o r the
p l a i n t i f f - s u b j e c t stated that the surgeon had acted improperly in using a new
instrument without the consent o f the i n d i v i d u a l ; that the doctor had a duty to
d i s c l o s e a l l relevant information, and that the use o f the experimental
had been imprudent. 1 0 1
procedure
The Court based i t s f i n d i n g s on the t o r t theories of
battery and negligence which are s t i l l
used
today in malpractice
litigation.
In t h i s country, the duty to d i s c l o s e was developed by the Courts in the
following o p i n i o n s :
In Salgo v. Leland Stanford J r . U n i v e r s i t y Board of T r u s t e e s ,
the Court found that a duty of f u l l d i s c l o s u r e e x i s t s , but allowed that i t may
be tempered by the d o c t o r - r e s e a r c h e r ' s perception o f the i n d i v i d u a l ' s mental and
102
emotional s t a t e .
Later in Natanson v. K l i n e , the Court began to apply the
reasonable man standard to t h i s duty when i t held that the amount of d i s c l o s u r e
fo
informed consent would be measured by the degree o f d i s c l o s u r e of a "reasonable
medical p r a c t i t i o n e r " J
0 3
In Canterbury v. Spence the Court s h i f t e d the emphasis
from the reasonable doctor standard to that o f the reasonable patient standard,
holding all r i s k s must be d i s c l o s e d which a reasonable patient would need to
know in deciding which treatment to select or whether to s e l e c t a treatment at
all.10^
The duty to f u l l y inform, e s p e c i a l l y in an experimental
_.
28
00029
situation
i n v o l v i n g i n d i v i d u a l s diagnosed as mentally i l l , was emphasized by the Supreme
Court o f Missouri i n Mitchell
v. Robinson wherein the Court, f i n d i n g negligence,
held that the i n d i v i d u a l had a r i g h t to know a l l of the hazards of the proposed
procedure and that the doctor had a duty to f u l l y inform him of the possible
collateral h a z a r d s . ^ 5
The individual was subjected to electroshock and i n s u l i n
shock f o r severe emotional d i s t r e s s .
As a r e s u l t of the procedure, the i n d i v i d u a l
went into convulsions which caused the fracture o f several
vertebrae.^5
In 1973, a Michigan s u p e r i o r Court set up a three-part standard o f
informed consent which i t deemed would better protect the r i g h t s o f
a l i z e d i n d i v i d u a l s in mental h o s p i t a l s in experimental s i t u a t i o n s . ^
i s composed of three elements:
and voluntariness o f consent J®®
institutionThe t e s t
Competency o f the p a t i e n t , knowledge o f the r i s k s
The facts involved in Kaimowitz were discussed
above in the section on psychosurgery.
The Michigan Court held that v a l i d consent
f o r the experimental procedure had not been given due to the circumstances of
involuntary confinement, the fact that the i n d i v i d u a l was in an i n s t i t u t i o n and
109
the fact of the experimental nature of the surgery.
The three-pronged
t e s t was based on the Nuremberg Code as the Court c i t e d in United States v.
Karl B r a n d t , ^ in d i s c u s s i n g the legal capacity to give consent, the a b i l i t y
to exercise free power of choice, and the possession o f s u f f i c i e n t knowledge
of the subject matter to make an enlightened d e c i s i o n .
On the i s s u e of competency,
the Court determined that i t required the a b i l i t y of the subject to understand
r a t i o n a l l y the nature o f the procedure, the r i s k s and other relevant information,
and that the p a t i e n t ' s mental problems, h i s confinement, and h i s
might have an e f f e c t on h i s competency. 111
institutionalizatio
On the issue of the experimental
- 00030
procedure, the Court stated that due to the experimental nature, the knowledge
of the r i s k s involved was very uncertain; t h e r e f o r e , the i n d i v i d u a l could not
112
have given knowledgeable consent.
On the i s s u e of v o l u n t a r i n e s s , the Court
held that i t was impossible for an i n v o l u n t a r i l y committed i n d i v i d u a l
to be
free o f r e s t r a i n t or coercion, e s p e c i a l l y where h i s release may depend on whether
he consents to the p r o c e d u r e . 1 1 3
This d e c i s i o n was very important in protecting the r i g h t s of
a l i z e d i n d i v i d u a l s , e s p e c i a l l y because o f the C o u r t ' s c o n s t i t u t i o n a l
institution-
analysis
f o r the protection o f the r i g h t of mentation discussed e a r l i e r in t h i s paper;
but there have been s i g n i f i c a n t problems and s i g n i f i c a n t questions
informed consent generated by t h i s d e c i s i o n .
concerning
Under Kaimowitz i t would seem
that determining competency, the a b i l i t y to understand the nature of the procedure,
i s in the hands of the r e s e a r c h e r - d o c t o r J ™
Competency i s a value-laden
concept and whether an i n d i v i d u a l i s or i s not competent at any given time i s
going to vary with the i n d i v i d u a l making the determination.
The second
requirement for informed consent, knowledge of the r i s k s i n v o l v e d , would seem to
have the e f f e c t o f making informed consent p r a c t i c a l l y impossible in any
115
experimental s i t u a t i o n where a l l of the r i s k s cannot be known.
One commentator
has c r i t i c i z e d the decision on t h i s point because the Court f a i l e d to d i s t i n g u i s h
between psychotic and non-psychotic i n d i v i d u a l s , saying that there are c e r t a i n
procedures which sound so f r i g h t e n i n g when explained that consent would become
v i r t u a l l y unobtainable from some psychotic patients J
The t h i r d requirement
of v o l u n t a r i n e s s would seem to foreclose experimentation on i n v o l u n t a r i l y
i n s t i t u t i o n a l i z e d i n d i v i d u a l s as they are captive s u b j e c t s . 1 1 7
00038
-17-
F i n a l l y , Kaimowitz
i s in c o n f l i c t with the trend in l e g i s l a t i v e action which i s g i v i n g
institution-
a l i z e d i n d i v i d u a l s the r i g h t to contract, make w i l l s , and vote unless there has
been a p r i o r adjudication of i n c o m p e t e n c y . 1 ^
This enlightened trend appears to
be based on the presumption that a person i s competent u n t i l the contrary i s
e s t a b l i s h e d in a formal hearing; and the theory that even though a person has
been i n v o l u n t a r i l y committed, he has not r e l i n q u i s h e d a l l of h i s fundamental
rights.
The same year that Kaimowitz was decided, 1973, the Supreme Court decided
Horacek v. Exon wherein i t stated that i n s t i t u t i o n a l i z a t i o n and legal
incompetence
are not n e c e s s a r i l y synonymous; that an i n s t i t u t i o n a l i z e d i n d i v i d u a l has the
same r i g h t s as anyone e l s e .
119
Several states have recognized t h i s and have
l e g i s l a t i v e l y e s t a b l i s h e d that i n s t i t u t i o n a l i z a t i o n i s not automatically
120
equivalent to incompetency.
VI
PRACTICAL PROPOSALS
To address these i s s u e s r a i s e d in the aftermath o f Kaimowitz,
several practical proposals have been put forth.
To begin, there i s a d e f i n i t e
need f o r a more precise delineation of a l l three o f the component parts of
informed consent.
Such delineation would spell out completely the method,
121
manner and matter necessary for informed consent.
There i s also a need to
have those a s s e s s i n g the adequacy o f informed consent separated from those who are
s u p e r v i s i n g the research program. 1 2 2
I t i s o f questionable consequence when the
doctor, a s s e s s i n g the competency o f the subject, i s a part of the research team.
A d d i t i o n a l l y , the Court in Kaimowitz did not address the i s s u e of vicarious
consent.
I f the purpose of informed consent i s to insure that each individual
-31-
_ . 00032
28
determines what s h a l l be done with h i s own body, the allowance of vicarious
TOO
consent defeats the p u r p o s e . U s u a l l y , when an i n d i v i d u a l has been adjudicated
l e g a l l y incompetent, he i s precluded from making l e g a l l y binding d e c i s i o n s , and
a t h i r d party i s designated f o r t h i s function.
This w r i t e r has a d i f f i c u l t
time accepting a determination which sweeps so broadly.
Just because an i n d i v i -
dual may be deemed incompetent to handle h i s own business a f f a i r s , i t does not
n e c e s s a r i l y follow that he i s not capable of meeting the requirements of consent.
I t would seem v i r t u a l l y impossible to eliminate v i c a r i o u s consent all
together;
but steps should be taken to l i m i t the s i t u a t i o n s in which proxy consent may be
used; and t h i s w r i t e r feels i t has no place in experimental s i t u a t i o n s
involving
organic therapy.
A second proposal i s somewhat more radical and c a l l s f o r the e l i m i n a t i o n
of the element, competency, in the t e s t f o r informed c o n s e n t . 1 2 4
This theory i s
based on the inherent uncertainty of the diagnosis o f mental i l l n e s s
on the l a t e r determination of competency/incompetency.
element may be used to deny an i n d i v i d u a l
initially
I t i s feared that t h i s
l a b e l l e d "mentally i l l "
appropriate
control over h i s body, h i s mind, and the imposition o f organic procedures.
Such
a determination takes away the i n d i v i d u a l ' s r i g h t to make these d e c i s i o n s .
I f there are c o n f l i c t i n g theories on whether an i n d i v i d u a l
i s mentally i l l , how
can one reconcile the negation of the i n d i v i d u a l ' s decision on the basis o f
competency?
Informed consent would, of course, s t i l l
be required before an
organic procedure could be used, but the competency element would not be an
element of c o n s i d e r a t i o n .
There i s some argument that t h i s element of competency
i s derived from the s t a t e ' s parens patriae notion of saving the mentally disorderec
00038
-17-
individual
from harming himself by h i s d e c i s i o n s J 2 5
wou-|<j s e e m
doubtful
whether such an i n t e r e s t by the state could outweigh an i n d i v i d u a l ' s autonomy.
A d d i t i o n a l l y , i f t h i s parens patriae notion i s continued, the state w i l l be
allowed to deal with the i n d i v i d u a l on the b a s i s o f h i s s t a t u s , an approach
1 ?fi
which the Supreme Court has deemed i n v a l i d .
The inherent danger in the status
approach i s that i t leads to the conclusion that i n v o l u n t a r i l y
confined
mental patients lack competency to make any d e c i s i o n s about t h e i r w e l l - b e i n g .
P r a c t i c a l l y , l e g i s l a t i v e proposals could be drawn which would eliminate the valueladen construct of competency and define informed consent in terms of knowledge
127
and v o l i t i o n .
A f i n a l practical proposal to remedy the problems with the present
informed consent doctrine i s based on contract theory.
undermine the requirements of professional
Such a theory would not
codes, or state or Federal
regulations
i n the area; but i t would give the i n d i v i d u a l an important role as the primary
decision-maker and define the duties and l i a b i l i t i e s of the medical
profession.
The theory i s based on the standard o f f u l l d i s c l o s u r e in every s i t u a t i o n J
Whenever a patient i s not f u l l y informed about procedures to be perpetrated on
him, he s u f f e r s a l o s s of i d e n t i t y and personal d i g n i t y and therefore feels
himself l e s s o f a human being and more of an object f o r manipulation from the
outside.
Being able to
130 give or withhold consent humanizes the therapeutic or
experimental process.
Under t h i s contract theory l i e two presumptions:
That every person has both the r i g h t and the a b i l i t y to give consent to a
procedure and that the doctor-researcher i s prima facie negligent any time he
proceeds without the s u b j e c t ' s consent. I -3] The four contract p r i n c i p l e s o f
00034
i l l e g a l i t y , fraud, duress and incapacity could then be argued by the subject
that although consent f o r the procedure was given, i t was not s u f f i c i e n t l y
informed consent.
1 op
Consent to experimentation would be considered i l l e g a l
1o
when the performance o f the contract i s a g a i n s t public p o l i c y , t o r t i o u s or c r i m i n a l .
The defense of duress could be argued in s i t u a t i o n s i n v o l v i n g e i t h e r physical
psychological
d u r e s s J
3
^
or
p o r example, i f a person i s i n s t i t u t i o n a l i z e d in a
mental h o s p i t a l , the circumstances of the surroundings are bound to impinge
1 35
on h i s decision-making.
In the same vein one must also consider the
1
p o s s i b i l i t i e s of any inducement or promises made to e l i c i t the consent.
The
Court in Natanson found that there was a f i d u c i a r y r e l a t i o n s h i p between a doctorresearcher and h i s patient-subject which imposes special o b l i g a t i o n s of f u l l
d i s c l o s u r e and good judgment in accepting consent or p a r t i c i p a t i o n in a procedure. 1 37 The p r i n c i p l e of fraud might be used in a s i t u a t i o n where there has
1 oo
been an intentional misrepresentation or nondisclosure of information.
In
most j u r i s d i c t i o n s , i n d i v i d u a l s diagnosed as mentally i l l
are no longer considered
1 39
incapacitated to contract absent a formal adjudication of i n c a p a c i t y .
The
defense of incapacity to a contract w i l l take on a d i f f e r e n t meaning in l i g h t
of t h i s new trend in the l a w . ^ 0
By applying contract p r i n c i p l e s to the doctrine
of informed consent, i n d i v i d u a l s who were foreclosed from the decision-making
process by the three-pronged standard in Kaimowitz w i l l not be given back the
freedom to p a r t i c i p a t e in decisions which affect them.
contract approach as the most practical
This w r i t e r views the
in l i g h t of legal considerations arid
the most humane in reference to autonomy of those approaches considered.
affords the i n d i v i d u a l
It
the respect and d i g n i t y due him by v i r t u e of h i s being
_ . 00035
28
human.
made.
He i s no longer a passive subject for whom and about whom decisions are
Rights and o b l i g a t i o n s which encourage rational decision-making can be
e s t a b l i s h e d under contract p r i n c i p l e s .
I t seems a more ethical approach i f done
at arms length, as both p a r t i e s are taking an active part.
Further, the contract
remedies provide an additional legal theory f o r the experimental subject beyond
the t o r t theories of negligence, battery and i n v a s i o n of privacy.
The Federal government, aware of the insideous problems in experiment a t i o n , i s attempting to update i t s regulations to protect would-be subjects.
The Department of Health, Education and Welfare has recently promulgated supplementary r e g u l a t i o n s f o r certain vulnerable categories of research
The mentally disabled f a l l w i t h i n these vulnerable c a t e g o r i e s .
subjects.141
The amendments
require that at l e a s t one member of the review board overseeing a l l
research
which impacts on the vulnerable categories be from a n o n - s c i e n t i f i c
profession,
such as a lawyer, an e t h i c i s t , or someone from the c l a s s of subjects
in the r e s e a r c h . 1 4 2
involved
The new proposals concerning the mentally disabled which
have been temporarily tabled, acknowledge that research i s e s s e n t i a l
ment of medical progress, but due to the d i s a b i l i t i e s o f the mentally
s t r i c t e r safeguards are required, e s p e c i a l l y in the regulation of
to the advanceill,
risks.143
This s t r i c t e r regulation of r i s k s was proposed as HEW, and l i k e the Kaimowitz
Court, considered the mentally disabled incapable of g i v i n g informed consent to
research in most i n s t a n c e s . 1 4 4
The degree of s c r u t i n y of the research to be
given by the review board w i l l depend on the degree of estimated r i s k in r e l a t i o n
to the benefits of a given
project.145
As a p r a c t i c a l matter, these newly proposed regulations w i l l be very
OOO06
beneficial
in protecting the r i g h t s of an i n s t i t u t i o n a l i z e d i n d i v i d u a l
labelled
mentally i l l .
In addition to the r e g u l a t i o n s , one must consider also the p o s s i b l e
constitutional
protections which can be argued to protect such an i n d i v i d u a l .
Experimentation on i n d i v i d u a l s c i v i l l y committed implicates t h e i r Fourteenth
Amendment l i b e r t y i n t e r e s t s .
Under due process c o n s i d e r a t i o n s , the Fourteenth
Amendment p r o h i b i t s the Federal government, the state or any of i t s agencies from
depriving an i n d i v i d u a l of h i s l i f e , l i b e r t y or property without due process
"I
AC
of law.
The Court in Vitek v. Jones recently affirmed the long held notion
that the l i b e r t y i n t e r e s t protected by the Fourteenth Amendment includes the
freedom from bodily r e s t r a i n t and punishment along with the r i g h t to personal
privacy.1^7
The r i g h t to personal privacy has been used to encompass an i n s t i t u -
tionalized individual's
r i g h t to refuse m e d i c a t i o n . 1 ^
The Kaimowitz Court has
held that the r i g h t to privacy i s expansive enough to p r o t e c t ' t h e r i g h t of mentation
from governmental
i n t e r f e r e n c e .
1
^
Because the Courts have been w i l l i n g to extend
fundamental protection to protect the mentally d i s a b l e d , involved in experimentat i o n , under the Fourteenth Amendment, i t i s necessary to examine the various
research procedures used on the i n s t i t u t i o n a l i z e d i n d i v i d u a l s to see whether
t h e i r protocals comply with due process requirements.
make t h i s i n i t i a l
The mechanism best able to
determination i s an independent review board.
150
function o f such boards where research i s f e d e r a l l y funded.
HEVJ requires the
Some state
l e g i s l a t i o n for the protection o f the mentally disabled has also implemented the
independent review board control to f i l l
funded.151
the gap when research i s not f e d e r a l l y
There i s an additional need for procedures to be e s t a b l i s h e d for
j u d i c i a l review of these review board decisions on due process.
Some c r i t i c s
of
the independent review board mechanism who feel that the board members, u s u a l l y
doctors, are not t r u l y independent have proposed a system for the use of patient
advocates whose functions would be to act f o r the patient and serve as formal
counsel to patients who wish to refuse to p a r t i c i p a t e in certain procedures.
1
Another approach which has been suggested to insure due process protection i s that
153
of a limited guardianship.
With t h i s type of guardianship, the i n s t i t u t i o n -
a l i z e d individual would retain a l l of h i s c i v i l
delegated to the guardian by the C o u r t . 1 5 4
r i g h t s which are not s p e c i f i c a l l y
The problem with t h i s approach comes
in with the underlying v i c a r i o u s consent element.
I t might be overcome i f the
l i m i t e d guardian chosen in no way i s connected with the experimental
situation
and i s not related to the subject; perhaps a Court-appointed attorney with some
knowledge in the area.
The experimental procedures, e s p e c i a l l y psychosurgery and psychopharmacology, described above are i n t r u s i v e to such a degree that the fundamental
r i g h t s of an i n s t i t u t i o n a l i z e d i n d i v i d u a l
be protected.
are not only implicated, but must
In addition to administrative review boards and l e g i s l a t i v e
requirements, t h i s w r i t e r feels that an adversarial
proceeding with representation
by counsel f o r the i n d i v i d u a l i s in order when the more i n t r u s i v e forms of
organic experimentation are being considered.
The Ninth C i r c u i t in Huguez v.
U.S. has held such a safeguard would be c o n s i s t e n t with the g r a v i t y of the
procedure:
" C e r t a i n l y a p e r s o n ' s mind should be as i n v i o l a b l e as h i s home, and
j u d i c i a l consideration not unlike that given to an a f f i d a v i t f o r a search warrant
155
i s not unreasonable. 1
In c o n s i d e r i n g the due process p r o t e c t i o n , the Court must review the
00038
-37-
s t a t e ' s i n t e r e s t s in having the p s y c h i a t r i c research c a r r i e d out.
The i n t e r e s t s
would have to be compelling to override the fundamental l i b e r t i e s at stake.
If
the Court, in s c r u t i n i z i n g these i n t e r e s t s , finds the major i n t e r e s t to be that
of the public good, s c i e n t i f i c knowledge, protection from violence, then
experimentation on the i n s t i t u t i o n a l i z e d i n d i v i d u a l
cannot be j u s t i f i e d .
If
the i n t e r e s t i s that of benefit to the i n d i v i d u a l , i t s t i l l may not pass muster
due to the high r i s k s inherent in the experimental procedures and the lack o f
data supporting the e f f i c a c y of the procedures.
VII
CONCLUSION
This w r i t e r has always viewed the law as a means of a s s i s t i n g each
individual
in achieving b a s i c personal autonomy.
I f in seeking to promote the
autonomy of the i n d i v i d u a l , there i s a concomitant delay in the quest f o r
s c i e n t i f i c knowledge or s o c i a l c o n t r o l , so be i t .
well
afford.
-38-
00039
The price i s one society can
ENDNOTES
1.
T. M i l l o n , Theories of Psychopathology and P e r s o n a l i t y , 1-6 (1973).
2.
R. Laing, The P o l i t i c s of Experience, 102-03 (1967).
3.
T. M i l l o n , Theories of Psychopathology and P e r s o n a l i t y , 251-57 (1973).
4.
T. Szaz, The Myth of Mental I l l n e s s , 40-43 (1961).
5.
McNeil v. D i r e c t o r , Patuxent J u s t . 407 U.S. 245 (1971); Jackson v. Indiana,
406 U.S. "715 (1971); O'Connor v. "Donaldson, 422 U.S. 563~[1975).
6.
Knecht v. G i l l man, 488 F 2d 1136 (8th C i r . 1973); Wyatt v. S t i c k n e y ,
503 F 2d 1305 (5th C i r . 1974); Macke.y v. Procunier, 477 F 2d 877 (9th C i r . 1973).
7.
Shapiro, L e g i s l a t i n g the Control of Behavior Control: Autonomy and the Coercive
Use of Organic Therapies, 47 S. Cal. L. Rev., 237, 244 (1974).
Barnhart, Informed Consent to Organic Behavior, 17 Santa Clara L. Rev. 39, 46 (197
G a l l a n t , Legal and Ethical I s s u e s in Human Research and Treatment, 5T~(1978).
8.
Shapiro, L e g i s l a t i n g the Control of Behavior Control: Autonomy and the Coercive
Use o f Organic Therapies, 47 S. Cal. L. RevTTl?37, 244 (1974).
9.
No. 73-19434 AW (Mich. C i r . C t . , Wayne C t y . , J u l y 10, 1973), Reprinted in
Brooks Law, P s y c h i a t r y , and the Mental Health System, 902, 909, note 18 (1974).
10.
Id.
11.
Barnhart, Informed Consent to Orqanic Behavior, 17 Santa Clara L. Rev., 39, 48,
note 7 (1977T-
12.
Griswald v. Connecticut, 381 U.S. 479, 482 (1965).
13.
White v. D a v i s , 13 Cal. 3d 757, 774, 533 P 2d 222, 223 (1975).
14.
Means, J r . , Law and the Physical Control o f the Mind:
Psychosurgery, 25 Case W.L. Rev., 565, 579 (1974-75).
15.
V. Mark and F. E r v i n , Violence and the B r a i n , 155-57 (1970).
16.
U.S. Senate, Committee on the J u d i c i a r y , Subcommittee on Constitutional R i g h t s ,
Individual Rights and the Federal Role in Behavior M o d i f i c a t i o n .
Washington,
D.C.: 1974.
17.
Barnhart, Informed Consent to Organic Behavior, 17 Santa Clara L. Rev., 39, 56,
note 65 (197777
00040
Experimentation in
~~
18.
i d . at note 66.
19.
Nuemberq Code, (1946), Reprinted in Katz, Experimentation with Human Beings,
305-07 (1972).
American P s y c h i a t r i c A s s o c i a t i o n : The P r i n c i p l e s of Medical E t h i c s . Am. J .
P s y c h i a t r y , 130: 1058-1065 (1973).
20.
Medical Treatment and Human Experimentation:
Introducing I l l e g a l i t y , Fraud,
Duress and Incapacity to the Doctrine of Informed Consent, 6 Rut. Cam. L . J . ,
538, 541 (1974-75).
*
21.
Jjd. at 542.
22.
488 F 2d 1136 (8th C i r .
23.
J. Katz, Experimentation With Human Beings, 440 (1973).
24.
id.
25.
R. Musser and J. B i r d , Modern Pharmacology and Therapeutics, 362 (2d ed. 1961).
26.
J. Katz, Experimentation with Human Beings, 441 (1973).
27.
R. Musser and J. B i r d , Modern Pharmacology and Therapeutics, 343, note 25 (2d ed.
1961).
28.
J. Katz, Experimentation with Human Beings, 441 (1973).
29.
id.
30.
Id. at 440.
31.
i d . at 442.
32.
D. G a l l a n t , Legal and Ethical
33.
Ijd. at 32.
34.
Id. at 20.
35.
Id. at 21.
36.
J. Katz, J. Goldstein and A. Dershowitz, P s y c h o a n a l y s i s , Psychiatry andj-aw,
423-59 (1967).
37.
368 F Supp 1382 (M.D. Ala. 1973).
1973).
Issues in Human Research and Treatment, 30 (1978).
00041
38.
i d . at 401-02.
39.
Mackey v. Procunier, 477 F 2d 877 (9th C i r . 1973).
See also Knecht v. Gillman, 488 F 2d 1136 (8th C i r .
1973).
40.
Mackey v. Procunier, 477 F 2d 877, 878 (9th C i r .
41.
No. 73-19434 AW (Mich. C i r . C t . , Wayne Cty. J u l y 10, 1973), Reprinted in Brooks,
Law, Psychiatry and the Mental Health System, 902 (1974).
42.
D. G a l l a n t , Legal and Ethical
43.
Id. at 127.
44.
Id. at 129.
45.
Psychosurgery, Boston U n i v e r s i t y Law Rev, and Center for Law and Health Sciences.
46.
Id. at 1.
47.
W. C a y l i n , Operating On the Mind, 29 (1975).
48.
Id. at 30-31.
49.
Id. at 39-40.
50.
i d . at 40.
51.
Id.
52.
id.
53.
Id. at 41.
54.
Id.
55.
Id. at 42.
56.
Means, J r . , Law and the Physical Control o f the Mind:
Psychosurgery, 25 Case W.L. Rev., 565, 569 (1974-75).
57.
Psychosurgery, Boston U n i v e r s i t y Law Review and Center for Law and Health Scienc
20 (1974).
58.
Id.
1-2 (|y/4).
1973).
Issues in Human Research and Treatment, 118 (1978).
"
00042
Experimentation in
59.
Id.
60.
Jd. at 21.
61.
Means, J r . , Law and the Physical Control o f the Mind:
Psychosurgery, 25 Case W.L. Rev., 565, 566 (1974-75).
62.
Psychosurgery, Boston U n i v e r s i t y Law Review and Center for Law and Health Sciences
28 (1974T
Experimentation in
'
63.
Id. at 28.
64.
Means, J r . , Law and the Physical Control of the Mind:
Psychosurgery, 25 Case~W7T: Rev., 565, 571 (1974-75)7
65.
Id.
66.
Psychosurgery, Boston U n i v e r s i t y Law Review and Center for Law and Health Sciences
31 (1974).
"
'
67.
Barnhart, Informed Consent to Organic Behavior, 17 Santa CIara L. Rev., 59, 59
(1977).
68.
No. 73-19434 AW (Mich. C i r . Ct. , Wayne Cty. , July 10, 1973), Reprinted in
Brooks, Law, Psychiatry and the Mental Health Systems, 902 (1974).
69.
C o n s t i t u t i o n a l L a w - - I n v o l u n t a r i l y Detained Mental P a t i e n t s ' Informed Consent I s
I n v a l i d f o r Experimental Psychosurgery, 50 Chi. Kent. L. Rev., 526, 528
(Win. 1973).
70.
JdL at 529, note 22.
71.
Jd. at 529.
72.
Jd. at 530.
73.
Jd. at 529.
74.
Jd. at 530.
75.
No. 73-19434 AW (Mich. C i r . C t . , Wayne C t y . , July 10, 1973), Reprinted in Brooks,
Law, Psychiatry and the Mental Health System, 902, 911 (1974).
76.
Jd. at 917-18.
77.
Id. at 919.
00043
Experimentation in
78.
Barnhart, Informed Consent to Organic Behavior, 17 Santa Clara L. Rev., 39, 58
(1977).
—
79.
V. Mark and F. E r v i n , Violence and the B r a i n ,
80.
_Id. at 85-94.
81.
T. M i l l o n , Theories of Psychopathology and P e r s o n a l i t y , 42-43 (1973).
82.
Id. at 42.
83.
A. Bandura, P r i n c i p l e s of Behavior M o d i f i c a t i o n , 509, note 71 (1969).
84.
T. M i l l o n , Theories of Psychopathology and P e r s o n a l i t y , 43 (1973).
85.
J. Katz, Experimentation with Human Beings, 450 (1973).
86.
J_d. at 451.
87.
Knecht v. Gillman, 488 F 2d 1136 (8th C i r .
88.
See Knecht v. Gillman, 488 F 2d 1136 (8th C i r . 1973); W.yatt v. Stickney, 344
F Supp 387 (M.D. Ala. 1972).
89.
Conditioning and Other Technologies Used to Treat? R e h a b i l i t a t e ? Dernol i sh?
Prisoners and Mental P a t i e n t s , 45 S. Cal. L. Rev.," 616, 631 (1972).
90.
Jd.
91.
Id. at 632.
92.
Id.
93.
New York City Health and H o s p i t a l s Corp. v. S t e i n , 70 M i s c . 2d 944,
, 335
NYS 2d 46 f , 464 TT972). See also W y a t t v T S t i ckney, 344 F Supp 387, 400
(M.D. Ala. 1972).
94.
Barnhart, Informed Consent to Organic Behavior, 17 Santa Clara L. Rev., 39, 60,
note 82 (1977).
~
95.
Id.
96.
F. Lindmein and D. Mclntyre, The Mentally Disabled and the Law, 149 (1961).
97.
Means, J r . , Law and the Physical Control o f the Mind:
Psychosurgery, 25 Case W.L. Rev. , 565, 578 (1974-75).
98.
M i l l s , Informed Consent: Psychotic Patients and Research, 8 Bui 1. of Am. Acad,
of L. and Psych., 119, 119 (1980).
00044
(1970).
1973).
Experimentation i n
99.
Jd. at 120.
100.
S l a t e r v. Baker and Stapleton, C.B., 95, Eng. Rep. 860 (1767).
101.
I_d.
102.
154 Cal. App. 2d 560, 317 P 2d 170, 181 (1950).
103.
186 Kan. 393, 350 P 2d 1093, 1107 (1960).
104.
464 F 2d 772, 774 (D.C. C i r .
105.
334 S.W. 2d 11 , 19 ( H ^ o ) .
106.
Jd.
107.
No. 73-19434 AW (Mich. C i r . C t . , Wayne C t y . , J u l y 10, 1973); Reprinted in Brook:
Law, Psychiatry and the Mental Health System, 902, 910-14 (1974).
108.
Jd.
109.
Jd. at 914.
110.
United States v. Karl Brandt, c i t e d in Katz, Experimentation with Human B e i n g s ,
305-07 (1972).
"
—
—
111.
No. 73-19434 AW (Mich, C i r . C t . , Wayne C t y . , July 10, 1973); Reprinted in Brook
Law, Psychiatry and the Mental Health System, 902, 914 (1974).
112.
Jjj. at 911.
113.
Ld. at 914.
114.
M i l l s , Informed Consent: Psychotic Patients and Research, 8 Bull of Am. Acad,
of L. and Psych., 119, 1 2 ^ 0 9 8 0 1 7
*
~ —
~
115.
J_d. at 123.
116.
JcL
117.
Jd.
118.
ki. at 123-24; States include: C a l i f o r n i a , Minnesota, Michigan, Massachusetts
New York, Oklahoma, South C a r o l i n a , South Dakota, and Tennessee.
119.
410 U.S. 113, (1973).
1973).
00045
120.
M i l l s , Informed Consent: Psychotic Patients and Research, 8 Bull of Am. Acad,
of L. and Psych., 119,"123-24 (1980).
121.
Id. at 126-27.
122.
Jd. at 125.
123.
Barnhart, Informed Consent to Organic Behavior, 17 Santa Clara L. Rev., 39, 40
(1977).
124.
Id. at 71.
125.
Id. at 73-75.
126.
See Robinson v. C a l i f o r n i a , 370 U.S. 660 (1961).
127.
Barnhart, Informed Consent to Organic Behavior, 17 Santa Clara L. Rev., 39
82-83 (19777:
Sample l e g i s l a t i o n :
Section (1): The f o l l o w i n g information must be d i r e c t l y communicated to the
patient with a minimun o f medical jargon:
(a) That the person has the r i g h t to refuse the proposed procedure and to
revoke consent, o r a l l y or in w r i t i n g , at any time p r i o r to, or in the
course o f , the procedure;
(b) A d e s c r i p t i o n of the procedure;
(c) The p o s s i b l e benefits of the procedure;
(d) The material r i s k s and adverse e f f e c t s of the procedure, and the extent
to which these r i s k s and e f f e c t s may be i r r e v e r s i b l e , taking into
consideration the p e r s o n ' s present physical c o n d i t i o n , past and present
i l l n e s s e s , p o s s i b l e pregnancy, use o f other drugs, previous reaction
to the proposed procedures, and any other circumstances that a
reasonably prudent physician would take into account;
(e) The degree o f uncertainty of the benefits and hazards associated with
the procedure;
( f ) That there e x i s t s a d i v e r s i t y of medical opinion as to the e f f i c a c y
and the e f f e c t s of the proposed procedure;
(g) In the case of psychological and convulsive procedures, the l i k e l i h o o d
that the procedure w i l l impair the memory o f the person consenting to
the procedure;
(h) In the case o f psychosurgical and convulsive procedures, that consent
s h a l l be f o r a s p e c i f i e d number o f procedures over a s p e c i f i e d period
of time, not to exceed 30 days. Additional procedures in number or tim
s h a l l require written informed consent;
( i ) That the person may take legal action against the t r e a t i n g physician
i f h i s or her r i g h t s as defined in these sections are v i o l a t e d ;
Of 046
( j ) That the person waives a l l r i g h t s of action against the t r e a t i n g
physician for any acts reasonably performed in accordance with the
p e r s o n ' s express consent.
Section ( 2 ) : D e f i n i t i o n , Informed Consent:
(a) An informed consent i s one which i s knowingly made without duress o r
coercion, and c l e a r l y and e x p l i c i t l y manifested in w r i t i n g by the person
to receive the procedure;
(b) No organic procedure may be administered to any person in the absence
o f h i s or her informed consent, provided that a p h y s i c i a n , spouse,
r e l a t i v e or guardian may p e t i t i o n a Court of competent j u r i s d i c t i o n
f o r an order to impose convulsive procedures where evidence i s presented,
and s p e c i f i c f i n d i n g s of fact made that a clear and imminent danger o f
immediate f a t a l i t y e x i s t s , that convulsive procedures would prevent l o s s
of l i f e , and that no l e s s d r a s t i c measures would avert f a t a l i t y .
(c) In a proceeding brought pursuant to section ( 2 ) ( b ) , the necessity to
impose convulsive procedures s h a l l be proven by the p e t i t i o n i n g party
beyond a reasonable doubt.
128.
Medical Treatment and Human Experimentation:
Introducing I l l e g a l i t y ,
Fraud, Duress and Incapacity to the Doctrine o f Informed Consent, 6
Rut. Cam. L . J . , 338, 547 (1974-75).
129.
130.
Idi. at 548.
131.
Id. at 549.
132.
133.
i d . at 550.
134.
J_d. at 552-554.
135.
136.
137.
186 Kan. 393,
, 350 P 2d 1093, 1104 (1960).
138.
Medical Treatment and Human Experimentation:
Introducing I l l e g a l i t y ,
Fraud, Duress and Incapacity to the Doctrine o f Informed Consent, 6
Rut. Cam. L . J . , 538, 555-56 (1974-75).
139.
Id. at 556.
00047
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'
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~
~
'
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0004