BMJ

Informed Consent and Research

Author(s): David Benatar and Solomon R. Benatar
Source: BMJ: British Medical Journal, Vol. 316, No. 7136 (Mar. 28, 1998), p. 1008
Published by: BMJ
Stable URL: http://www.jstor.org/stable/25178732 .
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Education

and debate

consent

Informed
David Benatar,

Department of
Philosophy and
Bioethics Centre,
University of Cape
Town, Private Bag,
Rondebosch
7700,
South Africa
David Benatar,
lecturer
Department of
Medicine and
Bioethics Centre,
University of Cape
Town, Observatory
7925, Western
Cape, South Africa
R Benatar,
professor ofmedicine
Solomon

to:
Correspondence
Dr D Benatar
dbenatar@socsci.uct.
acza

on whether

is ethical

of

the
opened
by
BMJ
if itmeets
the standards

but

Helsinki
Len

provides
for informed

the request

While

he

consent,

certain

An

here

is not

but

that where

this

it is not

the

been

that have
Professor
apply

Doyal
to research

to

specific

approved
thinks

criticised
for HIV

not

on

by
that
stored

the

one

Drawing

local

similar
tissue

with

be made
and

(g) that
information

ethics

committee.

from

study, which

for

not

tests,

informed

patients'
obtaining
a blood
involved
performing
thus does
and
records,2
three
not

does
this point
can, after
all, have

having
blood

consent
without

exceptional
seem
to be

consent

to test

would

not

his

pivotal
blood

interpretations,

but

it

seems

to us

that

or

is

may

sensitive

information
In

the

case

it

a
is

case
to

that he may

have
for

requirement
in this case,

but

should

exception

of no

for

argument
compelling
in this case.
be made

should

are the implications

be

to be made.

have

overridden

is

about

such
if

and

such

an

of

to this

the difficult

that no

that

consented

Thus,

important,

suggest
can think

of this for the Natal

went
to
researchers
study?
to ensure
that all but one of the research
great
lengths
status with
ers were
HIV
from
connecting
prevented
all means
of linking
the
of
Moreover,
patients.
identity
ethics

committee

tests with

the HIV
destroyed
are
there

at the end
no

unauthorised

given
have

that
been

even

avoided

are

status.

justified
that
agree

it is better

Even

or other
can

bring
if these

justify
the Natal

that
such
study

to only a limited

is especially
invasion
of

were

correct

to
then

of privacy,

even though

by encoding
that none
of

of privacy
if they

are

arguments

to establish

and HIV

If we

study.

shortcoming
the limited

ensuring
thereby
able
have been
identity
invasions

identity of patients

the

compelling
violations

This

degree.

and

the
of

is ethically defective,

Il

not

or her

his

knowledge
invasion
is an

consent.

be

linked,

the

she has

obtained.
gains
without

be

or violate

strong
argument
conditions
suggest
view
die
the
that

exception

in
of

Knowing
has HIV
does

who

person

will

consent

The

seropositivity.
introduce

can

record.

Doyal's
for

What

blood for HIV in the Natal study meets all the

conditions enumerated above. Condition (/) lends itself
variable

an

why

the patient
to the medical

autonomy

if he

subject
consent

cannot

of

obtaining
has HIV

person

arguments
be made. We

catego
a

to draw

it for HIV

consent

test

sympathy
informed

not
list of conditions
Profes
by the
permitted
problem
was
con
sor
there
that
but,
assuming
Doyal
stipulates,
of
sent
the anonymous
that
to draw
blood,
testing

to

contrast,

privacy
person's
information
being
when
the researcher

Professor

Professor

in

is unnecessary
or
withholding
providing
meets
the other
which
conditions

identity

that
cases

exceptional

consent

that person's

research

conditions

very

necessary.
the researcher
is whether

by the researcher,
there
is an unidentified
inhibit

informed

no

and

the

the

criticises

to obtain

is not

informed
involves

intervention

informed

unconsenting

subject

constitute

record to the identity of the patient

that
that

By
privacy.
identifiable

should

conditions

condition

overridden

viewing
simply
slot into one of his

precisely
ries. However,

without

will

findings;
of
categories

South African HIV

The

issue:

contact

of research

crucial

agree
research

He

another.

meets
the
study
in those
obtain
consent

We

not

donors.

anonymous

Doyal
consent

possible,

not
study does
a result
of research

study for failing

link the medical

that

the patient's
will
patients

the results are made public; if)

that

anticipated
as a result

patients
access
is restricted

is not

with

takes

informed

Trie

even

the research

(e) that, when

possible,
to connect
with
the records

are unable

and

which

but where

the patient whose

studied;

he

yet this
he must

thinks

an

is of suffi

the research

(d) that itmay benefit

are

records

(c) that

practicable;

as

patients
the result

what

consent,

the clinical record is essential to the research; (b) that

that

hand

he

informed

of

part

findings.
for
of the test, and counselling
Telling
but
would
constitute
such contact,
HIV
status,
positive
the consent
of the patients.
it would
be with
one
with
that Professor
It seems
then
Doyal
gives

He

consent

with

South African

other

for his defence

implications
on
research
thinks
that for epidemiological
consent
records
the informed
may
requirement
patient
are met:
to
if certain
conditions
be waived
(a) that access
consent

identity,

www.bmj.com

in
necessary
case is that of

uncontroversial

as

test

them

inviolability of

it is not

of

not be identifiable when

A longer version
of this article is
available on our
website

contact

(although
must
the other
be met). However,
some
seem
to have
mentions

requirements
cases
he

exceptional
unfortunate

the

that

even

patients

incompetent

to an HIV

consent,

that they had been

informing patients

merely
of

for why
arguments
be inviolable.1
should

powerful
consent

concedes

circumstances.

rigorous

informed

defending

vigorously

informed

research

the Declaration

without

is conducted
some

Doyal

ers

nw

R Benatar

Solomon

In the debate

cient merit;
BMf 1998-316:1008

research

and

regrettable
could

privacy

and
patient
identity
the researchers
could
a
patient's
that minor

link between
if one

thinks
on

limitations
great
minor

benefits,
intrusions

autonomy
one must
can

be

avoided.

Are the criteria for informed consent

the same

in Third World situations as inWestern

countries?

1 Doyal L.Journals should not publish research to which patients have not
three exceptions. BMJ 1997;314:
given fully informed consent?with
1107-11.
2 Bhagwanjee S,Muckart D,Jeena P,Moodley P.Does HIV status influence
the outcome of patients admitted to a surgical intensive care unit? A pro
spective double blind study.BMJ 1997;314:1077-84.

1008

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BMJ VOLUME 316

28 MARCH

1998