I
,
,
i
t
fuformedconsentih \'ti'":tf1
i medical research wid1out is to what d1e :L Doctors are arrogant to think they to debate issue of patient consent EDIToR-The
raised
d1eir
consent
when would trial.
randomisation have received Thus d1e in
d1e person of d1e
absence
stroke
need
obtain about
informed d1e different
consent, wrote clearly issues entalled and had
editorial
issue of
b y Richard P ublishin
did not
Smid1 in
b I 0 VIOUS Y agoruse
bell
.
.
d
a
b
bo
ut
tl . in
,L
uJ.e pro y reaso
ed orm
bl
nabl
em.
2 S
I
.0
c
...
d1e
g studies
seek P atients'
,os
eve bo 'L
UJ. stu
tha
t It was t'~..ec
es not to 0 tam
.~
wo~ker ~tud~eems defens~~~ I"did ~Uch. a stu hich -'L e I d ow your h mI Y c e stu ~m w UJ.e ea resear er, very COInmltted t ,L sch ht that ,L
UJ.e erne, uJ.oug no woman
.
e m ty 0
w
h
0
knew ,L
.vvomenwereran
of co
n
,L
UJ.e s
di
which
d1e
researchers
consent
y; I would
think
d1at of all d1e d1ere be peop le d1eir
were
In neIuJ.er case was ,L .,L UJ.ere any pOSSI
hannin ,L .. d .UJ.e
else2 TAl:
. f
ch
erne
wo
d
f . dwifi a mI
uld
omlS
. ed t
accep
0 ery care
t
an
b
eOUt.cu
ythin
g
Jr_-,
.
ibill
.:~
w
.
consent
1
Firstl
ty
P rofessions
any need
body
sort
would , onl y in medicine of debate about whed1er
g ...UJ. informanon was 0
that
UJ.e par.tIapants
an
Important pati,ents ,L .care. uJ.e VIew
~dicates
to be told
fluids, d1eir
that d1 ey" d1eir bodies
ernotions, or whatever
b
. ed.for d d1enotcare b of futureto I .be tam 0 su scn
seeking informed co~ent
ch Oiceo fthat regunenor . and ,L en O Utlcua standard O ,L Jr_--' UJ.ers were OUtJ.CU standard
0
Jr_-'
All
.
car study
e
onl of
y.
were
as ked around
to birth
consen and
regunen
t
t0 inter-
a
.not
events
to be subjects i on d1e part of askin g O p inions
of research.
This
is arrogance
a f~ure ~tudies.
to
respect
d1e
sU~Jects Wld1
~
d1ese d1e
viewed. do.
I d1ought
this we
was all
right
and
still by
of doctors. Has anyone d1ought d1ese " p atients" wha t d1eir
Indeed,
.d1e care
w~ch
Sometimes ctJ
randornise
people
are? I also countries about for like to anything, know that was a developing be sure research consent BrattPaediatTidan and think need not that d1at doctors to be only when country d1e individual~ done had especially from research. I read in a d1e on given consent in
Secondly, developing careful patients I would paper ~hom informed DavidE
ISsues were consIdered before starting d1e ..en studies and d1e safeguards that were P ut m ..consen place .mdicate ~t d1e reverse was true. Richard.SmId1 sh~uld.publish which There ~ut mIght for d1e ir!rmed IS clf}aTI>: d1e be conduc~ asked papers consent so w~e~er was n~t d1e.B~] st:u~es obtamed. such trials ~ descnbmg .much. m :which thatlt wo.uld
g era!
pra think we co uld ge t t t d n 0 ran offilSa on. H owever, we can still obtain consent to treaUnent
.ceo I d on 't
. .
consent we revive
I think person patient dose. patient's given, have but who Should
it is rarely
acceptable But d1e that do after
to an
treat overThe
a a
obtaining
wid1out
consider patient?
is unconscious suggests discussed
disagreern.ent be wrong d1~ results given d1e
from d1e
SItuations
action
consent or
is not I different
BMf, I can
I think
we might
it anyway.
BMf t? d.ecIiI1e to publish if d1ey have .been constItu~
recently
a trial
of d1ese studies ap~roval
med1ods
of treaUnent would
for d1ese cases. I think have to be d1at ifit is
of. properly
research IS ~thical. .By
my conclusion ethical inside outside a trial,
5 La Croix Avenue, Diego Martin, TriIridad Tobago, West Indies I Smith R Informed consent: the 1997;314:1059-60.(12 ApriL)
ethicscomln1ttees.~o.onecan~~ohave a m~no.poly on de:ading what
a trial it would be ethical too. However, d1e Duman
intricacies. B1\f/
publishing such trials d1e BM] will proVIde important material showing what different research ethics committees think. These data d1en inform d1e continuing debate wid1 decisions taken by a wide range of individuals, dealing wid1 real life
' Advice to authors m receive more letters than we can publuh:we can currently accept only about one thircL m
~o
o~e has a monopoly
..may on deCIding
what
d1e
15 ethical EDlToR-Havingjust term as chairman ics committee, d1e debate I have no come to d1e end of my of our local research ed1I would doubt like that to contribute to consent informed consent
concerned issues. Pat Soutter Hamrnersmidl W12 ONW
Past dlaiTman, research ethics committee Hospitals NHS Trust, London
prefer short letters that relate to articles publuhed within the past four weeks. W al5o publuh usually faoour some "out of the blue" relate to matters which letters, wh~ poliq. we ofpublic
on informed
When dciding 1 Dral L Journals ~hould n?t pubfuh research ~ which have not given fully infOffi1ed consent--'WIththree exceptions.BM] 1997;314:1107-11. (12 April.) 2 Bhagwanjee S. Muckart D.lJ,Jeena PM, Moodley E Does HIV slaWS influence theunit? A prospective admitted to a surgical in~ive care outcome of patients double blind
study (with commentaries
I andYKSeedat).BM]1997;314:1077-8~.(12Apri1) Denrus M. O'Rourke S, Slattery J. Staniforth T. Warlow C.
letters to publuh
should be obtained in virtually all research ...patients studies. The difficulty comes m d1ose rare instances consent may when b d1e need to obtain informed . e WaIV ed.L en D 0 yal has mad e
useful interestin contribution
g '. that, whereas .3
originality assertions supported by data ..' or by CItation, and a clear prose style. Letters should word have fewer than 400 words (please give a count) and no more than five references
one
:I'
a d1oughtful debate 1 but
and it is
to
d1e
by R Kale, S B~jee
et aI,
(including
relate)-reFerences '
to the
should .
BM]
be
article
in the
to which
~ncouver
they
would
have
saId and .2
that
d1e
study
by
Satlsh under tha .4
Evaluation of a stroke family care wader: results of a mIIdo~ controlled trial. BMJ 1.997;314: 1~71- (12 Ap~) 7. Tobias JS. BMJs present policy (sometimes approvmg
research in which patients have not given fully informed
style. m
welcome pidures. by each
.
Bhagwanjee his
suggesnons,
colleagues h
e seems to
qualified . I
Imp y
Letters should be typed and signed Lnd each hOT aut""" a aut ' s current
t
It
would The
not commentaries of Rajendra Kale
coment) 5 ~~~~
is wholly Informed
correct
B1\f/ 1997;314:1111-4. intricacies. BM]
and address should be statecL m to dclare any amJlict
eru:ourage you
consent: the
of interest. Please enclose a
and Sheila McLean were critical of d1e .two studies published in d1e BAg; 2 S but d1ey. failed to address d1e specific instead issues raised to vague to bias and by genconby has colnot to
1997;314:1059-60. (12 April) Let readers Judge am so my d1e patient Is it ever d1eir for theOlSelves statistician, is rad1er d1ereare not remote people to treat I consent? people a
stamped addressed envelope if you would like to krww whether your letter has been accepted or rejectecL m ~ post some letters submitted wid web before we dcide on in the paper say no. be edited and ~ beshortenecL version. to thu W will assume wnsent unless they to us on
d1e trials eralisations. sider not
and resorted Neid1er trials and defended d1e harm
EDlTOR-I doctor, from here: wid1out
a medical experience I think right
was prepared from which
the world publication specifically
seriously perfonning Dennis who
that can be done
.two issues
to randornise Is it ever right d1eir wid1out
that correspondents Letters will
been excluded Martin leagues,
as far as possible.41n Bhagwanjee d1eir
contrast,
consent? people be right
or measure think it can
decision
to randornise
appotntment
patients were mostly able to consent, as dIe mv test could presumably have been done afterwards with.stored blood.5 I think that study w:asU?e.thical. .I .think. It IS dangerous to Jet one moral prmaple-informed consent-c-becomeabsolute. Hence I would .not banish all such research from dIe BMJ and only if dIe editor thought the work indefensible would I keep it out If the issue was debatable I think I would publish the paper, though I would expect authors to jusrify their actions. Readers could then judge for dIemselves. Thanks for a stimulating issue. Martin Bland Professor medical of statistics St George's HospitalMedicalSdlool,London SW17ORE ..ethics 1 Dennis 9'RourkeS, ,M, SIa;ttery ], Staniforth Warlow 1; C. Evaluabona stroke of famiIy worker: care results aranof do~ controlled (widt trial commentari~SMd.ean, by M.Denrus).BMjl~97;314:1071-6.(I:April) 2 FlintC,Poulen~ p,Gr:ant ~ Know In1dwife A your .'. schemec--'1 random;sed of conbnwty care atearn trial of by ofmidwi~es.Midwiftry 1989;5:11-6. 3 BhagwanJee S,Muckart D.ll,]eena MoodIey,Does p~ E mv.5ta~ infi~ence o~tcome dte ofpanents admitted a to SUf&1ca1 mtenslVe UnIt? prospecnve blind care A double study (widtcommentariesR Kale, Bha~jee eta/, by S and K Seedat). 1997;314:1077-81, Y BMj (12 April) Ethics committees and the BMJ should continue to COnsl d er the overall b enefit to
patients EDrroRWe support MartIn
be seen in dIe context of deviancy from routine practice and judged against breaching dIe same principle the next time the same patient sees their doctor-that is, not being able to inform the patient fully of correct management, as well as the beneficence to many more patients. This utilitarian argument was made by Len Doyal in condoning the use of medical records,' and dIere is no clear justification of why the ethical issues for randomised trials should be different Adopting an absolute ethical view in open trials ignores the realities of-and would undermine the ability of research to inform-normal practice and thus could ultimately harm patients, including those who agree to take part in trials. The BMJ and committees should continue to judge dIe overall benefit for Patients. PaulLittle macome traini7lgfellow IanWllliamson Seniurlecturer Universi pton,p..;~~";,MedicalCare, tyof Southam ~ , AldennoorHealth Centre, Southampton SO165ST
smoking during pregnan patient dIat you are going from smoking eidIer by no or by haranguing her ultimate behaviour might this knowledge. This is a te It would be possible to set a two by two factorial in treatment factors wasinfo the other was whatever . ment was of interest The interaction between the support the hypothesis. I such a study has ever been help to settle the ques seeking informed cons results of a study. If the
~
f
,i
1
i i .!. :
..
implemented a ban on P without informed consent results of such a study see Finally, I applaud the open this.. ISsueto WI er d e d readership's views. I hop livel y response. 1 Dennis O'Rourke SlatteryStanifonl1; M, S, ], Warlow c. Evaluationasb"Oke care of family worker: results aran- Dennis0 Ch'lnter Principal of c dom;sed conb"Olled (widt trial commentaries McLean, BRI International, byS B'Ittle,EastS MDennis). BMjI997;314:1071-7. (12 April.)c.. 2 LittleP,WilliamsonWarner Gould Gandey 1, G, C, M, Kinmondt Open randomised of presmbing 1 Doyal ]0W11als AL trial L should pu not strategiessoreshouldnot publishresearchMarch,) for (8 which patients notgiven info have fully 3 DoyalL]ournals dtroatBMjI997:314:722-27. to excep,tions.BMjI997:314:1107-ll
2 Denrus O'RourkeS,Slattery M, ], Eval~tionofasb"Oke~ycare dom;sed conb"Olled (Wldt trial co
~=S~~~~;:;*4~1~ AV; et aL Psy Moodie c"R. Mark
patients have g;ven not fully informedconsent-widtthree 1997;314:1107-H. April.) (12 DenIIlS...exceptions.BMj m his
inform ..3 Risk of bias may be another reason not to
commen~~ohisandhiscoll~gues:paper partially that the deaslon to fully or
consent should take into account the likely -lr ...1..Cllect on IIDpOrtant outcome measures, as well as the benefit of good research for all patients: We made the difficult decision-in consultation with local ethics committeesthat patients attending dIeir general practitioner with sore throat should be asked to consent to the procedures and to the aim of assessing the natural history, but in trying to "mimic" normal practice, doctors were encouraged not to discuss the randomisation to one of three approaches in co~on clinical use: antibiotics, no antibiotics, or the offer of delayed antibiotics. 2 Randomisation to the three approaches replaced the normal bias or preference of the general practitioner, which the patient is also uninformed about We showed that prescribing antibiotics medicalises sore thrOat and increases intention to co9Sult We believe that a full diSCtlssion of the educational purpose of the research, and of the different management groups-which must be rare in normal practice-woilld havesigIlificantly biased the results so that groups would have been much more similar. High prescribers would th~ .seen~benefitfrom changing their pre" scnbmg, WIth encouragement to waste dIe 6Om-120m of NHS money spent annually on sore throat, with disbenefit to all future patients. Similar arguments apply to fully informing the control group of many other important open studies-for example, effect of leaflets on stopping smoking and the Oxcheck study. The technical breach of autonomy-to give complete information for some patients on one occasion-has to 1478
seek consent ..study. EDIToR-ReadingUllUugh .1.. vanous artlUle cles in already held that there are situations in view I the 12 April issue has confirmed the which informed consent is more trouble than it is worth. Consequently,lam of dIe view that dIe BMJ was right to publish dIe papers in question and would be wrong to impose a ban on publishing such papers in future. The rights of individual patients must, of course, be protected, but not to the exclusion of all other considerations; people have obligations as well as rights. I consider it sufficient that a study is approved by an ethics committee. If the members can be convinced that the study remains ethical without informed consent, then the paper should be considered for publication. It would be unethical not to publish a sound and valuable piece of work, thus denying useful knowledge to the medical community simply because informed consent was not sought Presumably the lobby in; favour of the ban hopes that such studies would not then be done. This I doubt I think any policy adopted by the BMJ on this issue sliould be framed in terms of ethics committee approval. If the BMJ. decides to follow ~ policy alo.ng the lines proposed bypoyal1 I woilld like to see at least one other category of exception-that is, where there is a perceived risk that seeking informed consent might bias the conclusions of the study (as in the stroke family care worker studt and the breast cancer study of McArdle et al'). As another example, suppose one wished to set up a study comparing methods of persuading pregnant women to stop
patients und~ing.breast cancer BMj 1996;312.813-7. Cliniaans are bemg dism
~ ". I
I
.j
~i
themselves EDrroR-I would like to about the relation betw medical research and thej: medicine. Clinicians play great majority of medical and the framework wi practice medicine plays a ment of the ethics of Although the principle of. is widely accepted, the different, as illustrated by report of the condemnatio study in India of the clini cal dysplasia.I The stu because the available evide to quanrify the risks of dys that cervical dysplasia n spontaneously rather cancer. A gynaecologist study argued that it was "the investigators had n study participants that known to progress to clinicians ~~ being. th~elves It IShard!ose.. truly honest with their pati In Britain, ithousands treatment for cervical dy believing that it is saving wh~ the chances are subjected to an unneces This suggeststhat dIey ar false pretenses rather informed consent BMJ VOL Cl pr pr 01: w< to th gr p\ ce ti< E. 3I la
p a: ./ 0 TI
I
Lean, three I? the the Ind :Ier :Ier :Ier hat ~atlers ady .hich { uld the , ~is. the \ )WG. :In: 1 her uld 's
-,
the an
ran-
as
b
to
a
y
fi ~ \
i
"
'~
I
~the
~Strategies
~~articular the the EDrroR-JeffI:t;y We 3 on this .orme m 2 OX3 Public Health Sarah righiway praCtIce, will ...',. 1 obtained, abused and the P ticipate wo ally of proceed view,s public proceed would now round groups clinical a~?sphex:e to reverse
~onsent, ~:. Its
itesponsibilities
~d grou.p theIr works professionals
,:esearch,
:;.
cal
language,
are
Educating
tIon,
~epts
public
to
ongoing
promote
Clinical
nals
epts Smith Mudur called
314:1059.
roblem
research the lffiprovement uld
consent.BMj
Anonymous.
in
~e~elop
Such combat BM] of would
need It
students game.
The all
all
which
If,
greater is ..
well, been 7LF
the refused
and
be
~o~tIon is
Health,
Stewart-Brown
such unethical should have the Inight R voice, b p Services results
will
ldentifi~s
directly
as
educatIon G. of instudiesWithoutinfotnied.cQns~n.t; O
Trials, by excellent ben.efit e atients
this ~.
as proces~ than (12 Infonned gr making c:onsum.er~' Ensuring p
is
d
4
proposed,
cooperatIon, a Indian encouraged Resear~ concerned thou~tful abuse earmng I ening is won't
for
probability
2
which
study.S
that
and
solved-but consent
members
and outsIde All 1997;314:1134-5. S th~tr new fffilStnIstbypatIents University a atmosph~e April) the ounds
identifyin!!;
the
create
understanding
as
informed
about
research as of informed
to
and Coll~ratIon Research BMj treatment be a
would ~th
educatIng
a
be responsibility
when Perhaps distInctIve some in present study solve
~doffilSatIon,
who .
P
With blanket an and
problem
ublish
protocols image .S researchers mvolved
of
co~t: 1997.314.1065.
the
h~d
the
will
abou~ that
patients, a the that that
.
m
, leaflets
res~ch
a urgent. of Director
the
th the
of
extreme 15
of
had
time,
are
res
~~ more of and .different studies. it
promotIon.
TobIas
debate
Wld.en
It
e
while ~dvisory. bystanders2 Unit, women anonymous the to
be to; for those the
different
shared
the
15 professIons, ~e ban system tackle their consent Oxford,
the.
lesson earch
though the consent
BM]
children (12 by of we. trials
poorly.understood
~cal
volun.teered
approprIate
right
cl~ber
p~blic ~e
for
working m. Department
..are editorial
energy,
of
seen arena sees April) inbicacies.
~eed
results
of and r~search 15 mvolVlng ethical
balan~g
concep~
appre~tIon to (12 must can debates I?entified on on who
lffiportance
with
and
~portanc~.
do
wo
not
research
responsIbility, patIents. benefit this the Oxford
the
P
to contribute April)
rISk
If
the
are artIci
attitude t~ have t? Group
.trials.
cervical publication
the
researchers uld
not
and who have
when
in
had
other
thin
and
.informed hard .begm .but
m
obtamlng of
name personal group problem board
the
percepBMj given
advance helpmg need
prepare to~
way clinical way to even-
to
infonned
studies
~
of gs
p
as about those of been lesions were
to
medi-
as
good-
...interesting
these
jour-
Con~a~e
atIon. .b:en
conThe 1997;
]OlIl par-
tht;y
..real
wa
the an us of to of to to to
for th
an
all
an
tu
to
of
of
o;f a
It y e
,
H
Grattan
Women's
mtern1tiOnal (lIlcluding ?i5cussion
Wend
institutional
publicity,
disseInination
ownership
issues,
cles that the example, sufficient ask small Many thought recently
for
this theargum~t that Asian .
studies.
I
WIth
le~gues should ethical informed
need concemed arguments. a the I? in
than
where countn~s research
individuals
unde~e
researchers
E:orro~~1 Minimun: vary
5
4
3 -Ltiilcet.1992;339;~4-5,
2
1 31Re
Group
Hazel
have impoSItIOn
disCUSSIO~ cl
owevex:'
think
Chapman
breast
Thornton clinical
business! S
~tntonH.A-!adyplan"fortrialrecruitment?Everyone's
BaumMThe
Th(12 consent)
research
Tobias
..'
it; Although I medical
the such
u
policy
in a chief, d individuals
ethical
ornton
great
April)
among g
for
a
would agree an developmg ~ elite
to
0nr011995.21:136-9.. Tho~t.on
study
people
=-:"'7Tenl
entStreet,Rowhedge,ColchesterCO57EA
Holmes countries, trials? ]S. responsIbility
Street,
such not subjects
simple
But
Health, be a
that
clearly way, been
lA1u:et
in
Clinical
ethics
etc w?eretht;y~y
a m
not and
R HM is a
countrIes.
from to.
care
consent BMJs which ethical am
and vary village By certatn 15 sess~on. mdiVldu.al' Issues qualitatIve
of
but
some
.UD
Health taken from. on professIon ..alth one
editorials
What
but.
In:
be is Although
on
ethics .reas Hall compr.ehenslve coun
wholly
Carlton, that
ethics
(in~uding
as
y?U
B
data, minunum not ~ed ~~d .to
tea~g
1993;341:?96
Lecturer obtatn. ~onsl~ered all also colnlnlttees,. that tht;y .thics in
language
Sa1Is~
Tobiasj..Houghton],eds.
Universi.ty
valuable.
m
of ax.nng
very
glad patients can
present
Trials C~1ruNJman,
~
informed co. keen
time
(m ~OIJeTsie5,filtUre
course
~e
offandQnused
,should developed.countrIes orm~ countrIes,
theIr
are.
have
need t
Programs,
.an
~to means chief. reqUired there
standards press).
can..
m
patientscontn"bute
data,
commumty to),
correct
trt"
Vlctona nug~t from ~ormed .
helpful.
studies on
es
cOlnlnlttee)
to
~at
to
~t different
Bhagwanjee. try
The
m~cal
certrials
actIVIty
ha;ve
have
policy
out research-sometunes for lffip'rtant
study acc?unt countn~ cultural. IdentIty, not consent tend d
research contrIbute.
tune,
o~Melbourne, ' partICIpants I where
~o~ed
ho,,!
on
e '.
responslbili~
ethic:m
IS
consent" you
reffilIld get m am believe,
not
not CImSumerS
BMj
Key this
c?~nt, a say
the
every
.
(so~etimes
3053, courses
.--,r-
different ~; a
~
mcluding
controlled
to
and .group
on ~
I?
.to;
yet
a ~ven ~o
should
.publish
con~en~
way. rese,arch, have. dil.aiorLt
P
Centre I
SerIes sensItIve dang.er
ethical15sue~
wary
no.
' atient's
m~o~,:ement, be members
1997;314:1
establish
HIY m to developmg
app~?pnate
consent.
w
in
have
oug established
meth~
Australia
differen~es
to Newhorlzons
~e from, that '"B
fully
hich
would indiVIdual standards
readers
an~
~~surmg
or
part.
.consent). the 15sue
happen.
research
Advisory
of hth
open~ approVIng I trials.Eurj vi
21~ u
pnvacy,
for ~th~r heard argue,
e~cal
of SaId
reaso~
status,
not London:
design
info~ed
mnint.
tif ~ome
we
~m, ~a~e ways It ~y
such
such
.designed II of. that ~ .this
~and
col-
be
an 1Il
for by
for we
ere
1-4. . d of In
all
of 15
a
of in
r~:nhL~~ experience South Without that tation consent and prohibits im their
must
patient's
break
what
informed
asking
this
stable
encourage
shame
~~emberg
sates
practices
heid
:~
as
same
.rnf:rmed also
physical
science
based WI conducting
his
g 1898
men
and ity
Helsinki
accepted (big
extreme
ethics
ing
partners lost
apartheid the
missed
researchers
patients.' stud
should EDITOR-I
Nurembergandapartheld South 2 1
i
.
onococcus
th
andYK
study AN
surgical Bhagwanjee
{12 lnfonned
medical
of
Bhagwanjee
generation, Even
ethics
respect
out
informed
democratic
the civilised
most y tatI
case
suffer?
women?
rtance concluded
April)
for the importance years, in study
the staWs
and
not
new
Albert
readers its but
door
African
and
that (with African
'
for
on an opportunity th
patients' dying
publish Seedat). injury
that
the
intensive
right declaration fu]filled home absolutely
be
right
in ethical
pressure
all
before
unethical In
consent:
were consent
elf
infiuence
~ judgment
consent
influential) treats was human
failed
commentanes
ground
why
it comlnittee of was and for on
.Th
Opportunity S,
mankind
after
19472andthenreasser.ted.
over from and atn
violated how
and
This
There to
injury
partIcular
consent
experiments
world
Neisser,
Muckart
that And
the study patients
the
consent
of
in BMj
to the
for
was alread
Private
study
care
condoned?
of deemed practice.
world
the
publish
a
patients the
the astollished
the
consent?
scientific
waive
and criminallaw;4 that
apartheid,
the
its
to
the
study lack the for the The
.actitioner many country
give
South 1997:314:1077-84. from
their
in
pre-eminent rights
that rights
prosecut
practice
.unit?
inbicacies.
this
is considering any victims
BM]
outside
outcome
of
democratIc
to
patients..
seek
D.IJ,]eena
findings
horse
1m the
no
Nuremberg
raises
by
research?
colleagues of inte.-vention because
not
the
in who
and in BMj,
or
c::riteria
how by show Helsinki 1964s, prospectIve
views
these
A
raises
R
study human
to
point of
patients' patients'
e
all to
.
even
the prospective to " Kale,
the of the good
should
Withhold How during progress.
disci
discoverer
taCItly of
on
With ed
an
teach
BMJ
Afri .
even
has were
approve
forms fail patients be
to
from
p~
and
Who such
the
ca,
the patients
Its ..
on
human
The
consent
that
paper United
unambigu1l;S the
. of
S
was
in
the
in.the
1997;314:1059-60.
~estIoi1able
P=""!~
an
stand
it
for
local
Bha~Jee Moodl~ professor of of 1;~~~, experim.en-
escaped
many
y standard
I
an confines P declaration to
ghosts
(12
the
closing black
the
recognISes d prostitutes!
condorung ares
them
a
fail the
it consent
state
ractice. mViolabilof
e
then
indirectly
g?osts
unethical mankind nght comI:>ens~cient fined
code
d
BM].
the
April)
admitted
doub!e
going
group
15 causing
consent a
issue
Without
observe authors
has
expenface Would
emergeditIon
gumea
, ap~of
before
..recent of
up
to
b
of
th BM
King-
a study
court
!!
ear P.
y
~
men of a;is that how BM]
5 the
the
the
was h the et lor th r for
blind Does
the
see
the
bIg
14
to
In to
In of of .e It
ch
~
of
?f
of
as of
aI,
a
'
etters
I
,
I I
i
! i
1 Bhagwanjee; S. Muckart Jema MoodI~P.Does technique is the most ethical? I SU D.D. PM. ggest that mv status inftuence outcome panents the of admitted a to " .. surgical intensive unit? prospective care A double blind the least unethical solution IS to conduct a sWdy commentaries Kale, Bhagwanjee (with byR S It al, good, well planned, vetted, and approved andYKSeedat).BA1f1997;314:1077~1.(12April) ; .. 2 The Nuremberg code (1947).BA1f1996;313:1448.trial even if previOUS consent cannot be (7December.) obtained in all cases and then inform the 3 DedaralionHelsinki. 1996;313:1~. December:) Patients or in this caseP of BA1f (7 arentsafterwardsIf 4 VollmannJ,WmauR.Informedconsentmhumanexpen-: .'. .'. mentation before Nuremberg BMJ1996;313: such trials are refused publication It will the code. 1445-7. December.) (7 impede research in emerg ency Procedures 5 SmithR. Informed consent: intricacies. 1997; the BA1f .. 314:1059-60.April) (12 and those that are published will be unsatisfactory because they will not represent the Consent is not always practical in full range of patients. emergency treatments Colin Morley Clinical direaor E Richard S . th ks d .Neonatal Intensive Care Unit, Addenbrookes ?lTORInl as or rea ers Hospitll, Hos ita! Box226.Cambrid CB22QQ VlewS on whether papers should be pubp ge lished only if there has been informed consent for the study! I agree completely that for the vast majority of clinical research the patient should be fully informed about all aspectsof the trial or study and their consent freely and willingly obtained However, there are occasions when this is not practical. In the main, these are clinical trials related to emergency treatment Some aspectsof care of newborn infants at birth have not been properly investigated and badly need data from good randomised trials-for example, the treatment of meconium aspiration. When meconium aspiration has occurred there is no time to ask for consent to a trial and it is rarely possible to predict the problem and ask for consent beforehand Even with warning signs the mother is not in a position to give fully informed consent; the father may not be present. and even if he is he will be worried by what is happening to his wife and child so that it is inappropriate to try to inform him about a randomised trial and ask for his consent There are several possible solutions to this problem, although none are ideal. (1) Inform every woman entering__the maternity hospital about the trial and ~f6r consent if her baby has meconium aspiration. However, to obtain such blanket consent in a busy delivery unit would be difficult and probably inappropriate as meconium aspiration occurs in a small proportion of babies. Consent would not be obtained from a woman with an acute problem on admission and the baby would not be enrolled This will bias the trial because such babies would be likely subjects for the trial. (2) Enrol only babies for whom consent could be obtained from the parents. This is possible, but it is likely to result in a biased trial because the most difficult acute cases will not be enrolled and therefore the babies will not represent the full clinical spectrum. (3) Conduct a trial with the approval of a professional peer group and the hospital ethics committee that asksfor consent when possible, but if this is not possible because of the nature of the emergency the patient is allowed to be enrolled in the trial. The parents would be informed and asked for their consent as soon as possible, allowing them to withdraw from the trial they if wish. (4) Not do a randomised trial and continue to use the unproved treatment None of these solutions is ideal and all have ethical probleInS. The.question is which 1 Smith Informed R. consent: intricacies. 1997. the BM] 314:1059-60.April) (12 . . Children from the age of 5 should be presumed competent EDIToR-When considering informed consent in medical research Len Doyal states that one of the d1reecircumstances in which research should be allowed to proceed in the absence of informed consent is when subjectsare not competent to give consent 1 One group given as an example was that of young and immature children. Before this statement is accepted the terms young and immature have to be defined Alderson and Montgomery argue that children can and should playa greater part in decisions about their own health care.2 They recommend that any child who can express a view should be given information, listened to, and have his or her views taken into account when decisions about treatment are being considered Their suggestions for a statutory description of capacity would be present when a child understands the type and purpose of the proposed treatment. the nature and effects of the treatment in broad terms, the principal benefits and risks, and the consequences of not receiving treatment and when he or she has the capacity to choose whether to accept the treatment When children are competent to take responsibility for a decision the responsibility for that decision would become theirs. ';[11ey argue that young people from the age of5-that is,of compulsory school ageshould be presumed competent The young age waschosen as the presumption does not exclude parents from discussion. It also encourages reCognition that young children may be competent to make' certain decisions-for example, whether to take more analgesics, if not more complex ones-and allow,s for the children to be deemed not competent and for their decisions to be overruled, especially if their decision would result in seriousiITeparable harm to their health. Perhaps these criteria could be used as a basis for discussion when considering how to assess children and young people's competence to consent to participation in research. This would be in line with Doyal's additional statement that "the levels of autonomy that patients w~o are thus incompetent do possessshould still be respected (for example, if they resist participation then it should not be forced)." I
a 51 situ; its I infc tanl
:: 1D p 2~ 11 co (J
BM
'480
Letters
-"
Its, ng Its ne )w ciof he ng ,e-
environment, results ar~ n~t gwde~es addressm!? petent canvassmg
which
could with go full
yield potential. some ~y
important disabilities, Doyal's t?wards
Failure controlled
to publish trials for help
completed is unethical to in deciding
randomised in itself Richard the BMJs would SInith's policy argue the to wishes
by journals experiments s~dard eVIdence. prospc:ctIv~ infarction death.
for
too
long} that when
Subjects they are there.
in
some is no a
for patients cer~y
learning
believe trea~e~1 of utili~. mul?centre m which no
receiving
us2ed to ~eir
EDITOR-In request on
response
Recently study statement cons~t. oversIght ~?ether trial. ~ve may
I reVIewed. ~f m~ocardial pomts mclud.ed ethics about
the ISsue of consent althoug~ more VI~S of SerVIce users
WIth mcomwork, ~d such as ~ers
informed in present
consent, favour of position.
I we
~atI~ts,
strongly journal's
maintaining Nobody
the end
There.was
and pro.motIng advocacy for this. client group: will be necessary before the ~tI~of unethicalrese.'fch stops beneficial treatments from bemg used .patients A Hassiotis Honorary senior lectUrer in detJel!lPmei1tal and BehaVlo~ London Medical
promote unethical research, but failure to publish completed randomised controlled tIia1sisunethicalini~.ownri~ht:the~fforts ofall wasted, those and are who both pal11apated health of m the professiolials information trial are and that
appr?val.orinformed that if this was not ~ "Wo~dhaveto ~ecI~ publish the an unethical subjects When consent ~oer~ed It of who I difficult recent were
.Isu!?gested f:he Journal It wants to consent if may be or find from ~~ military an aware staff about is
informed still
disorders and karnirg?4ability Iid1 Tee .1 ~!icy .to D~partment .of P~ydliatry ~~~ii~:~~W1~o~1r
deprived
exp:rimen~
be.unethical
they may need to make informed decisions.2 Th~e. isa good ~eaI of hypocrisy in cIinical mediCIne about informed so that unclear their These consent. have true Many been benefits and
IS not given freely. Subjects by poverty into participation to refuse a request
Smith R. Informed consent the intricacies. BMj 1997; 314:1059-60.(12 April) 2 DoraJ L Joumals .should n?1 publish research '? which pabents have not gIVen fully informed consent-wtth three exceptions. BMj 1997;314:1107-11. (12 April) 3 Tobias J~. BM[s p~ent policy (so~etimes approving research In is wholly correct not given fully informed consent) which pabents have BMJ 1997;314:1111-4. (12 ApriL) 4 Neuroscience Approach to Human Health Initiative Steering Committee. Mmtal handicap research:new techn%giesand approaches. Report oj wurkshop Ihl orgrmistdunderIhl initiative steering Committee. Approat:h to University of Initiative oj Ihl Neuroscience Warwick: Human Health Warwick, 1993.
so called' poorly and should risks
established remain
treatments
employer,
colleague,. research ordered
or te3;cher. mvolVlDg to volunteer.
evaluated
still be regarded
.. as experimental
treatments
have
particular
concerns
Yet, because they are accepted, given WIthout any form of
they are widely consent b~mg are ~t asp1. cortIrisk of
research performed
in diving medicine. outsIde hOSpItals and
Most WI th out
th e
b
required For example, many treatments I ,'" . WI'd .ey us. ed m uw.erent countrIes to patients WIth acute stroke-for example, h eparm, 5'ycero., I ha em odil utIon, ',,1 ' . nn, costeroids, definitely ancrod3 been 4 -but none shown and to reduce many the risk more ~f consent trials for but of the informed could the
safeguard of hospital ethics committees. In Div . I rep.rt ed th.a t vo Iume. 9 0 f er magazine Undersea
ed 1
en !at ts :l aI"~le ~ ~le , u: ~ ill~ l"e :Jly hiS re4 ed ng ~t 1.cs
h
Ill
saen
. andc HyperbarIC 0 fPhysiology47contamed tifi hich d . papers, w escn bed
research.' Twelve studies were on who of the that seven conpapers and 35 on so called military diving research. that ethics 12 mentioned were participants. be best described for the volunteers, staff or employees organisations Only approval informed highly
of these have
human patients were ducted
.., St:udies Wlth?Ut published EDITOR-YOur consent made where for fascinating informed d~ate medical Wl~ Important consent patient should
.death conclusIons be but ing agents
or disability patients-for could
be haIm-
often the
example,
antithrombotic of intracranial patients ~ this already are in rcmIS rarely strinin
commercial
increase Many
haelnorrhage.' on informed. research and is, this and is patient week not, dis12 expo.sed doffilSed questioned gent
mentioned and Some survival only
was granted consent. hazardous in studies
to this abuse controlled Hardening
experiments
reading, consent
the situations
and might
as adventures Many
requirements
consent
appropriate were cussed by Len.D~yal That so the tha~ drawn researc? a study IS of
comprehensively and]effrey.STobias.
rcmdomised controlled aI::Ids~errcmdoInis~trials uncertamty over
trials will lead to fewer and continued and to ben~ts c?n~~ed clinical of
failed to mention adverse effects, When they did, it was evident that at least 38 of the so called in vol~teers which had were to decompression often ~ve are ago too a illness small statistically not the above Medical or !
IS methodolo.gIcallysound CO~clUS10ns nnpo~ce we face m auth?rs. who can an~ medical have b.e IS
thensks an~ h~ce
meanmgful paramount I;>roblem those.
~y WIde~e practice.
treatments
stiIdies result. Senior
abuse of patients
consentm
incorrectly valid
designed institutions Eight Council
I
greatest
While
Carl E Counsell.
Clinical researchfeUow
spent tlme and effort adequate to produce b bl al ha pro a ~ so ~e consent m appropnate
a
perli ect
corro:14Uon,
_1_':
m desIgnIng a study a b. sounded paper will in ed 0 tam. .orm cases, this will not be
partly because of vary,.
Peter A G Sandercock* Reader in neurology Department of Clinical Neurosciences, Western General HospitaI, Edinburgh EH4 2XU *Peter A G Sandercock
tor In
reproach. Research Panel di
ver
years
proposed
super m
.
th
.. e mternatlo
nal
IS the prtnapallnvesngak trial slro e ( a = d
' ed offilS,
D ecompress10n.S. less ckn introducing "professiolial edical "
s.
Like the
super
current .
.e Ll1l, :>rI t's
ing
interpretations case emerg~ b ' u t
of An with no bli
what valid pa
constitutes a d P P
an er will tant
trial with the
of aspirin acute
and heparin stroke) and
in both Stroke
20 000 Group
patients are and of
medical would diver's be
assessments, performed but investigations . career would
th~
m~cals durmg additiolial a
appropriate therefore ons con clusI pro
occasional tI.an t en
authors
at mtervals include such as
members
of the Cochrane
ng
to
Ier .elf
elf
1tIon on pu cation 0 P a p ers .stro ?ut patI~t consent would cause valuable information to be absent from the liternture,
scientificall .mo y and ran tabl y
hiib ..
.
.
f
nnpor consent
A
.w WIth-
same department as Martin Dennis et a~ d ed lIed trial eval ose = OffilS contro uating k 1:__:1 k blish e 1d1!WY wor ers was pu ed In the 12 April issue of the BMf(pp1071-7), .~
h
.
.
.
cli
expensive
radionu-
de scannm g .The results were to be used in a prospective survey of long term health hazards f di Vlllg, b .ut. th.e di vers w~e to b e
.
a
1
SmIth
R.
Informed
consent April)
the
intricacies.
BMJ
told tha
that th
It
was
for
mdiVIdual
screenmg
and
he cal Jas .tant,
~ItuatiOn.
Each
paper
should
be judged
unaccep
on
e
2 Chalmers L Undelreporting research is scientific miscond?CljAMA 1990;263:1405-8. Lindl';Y RI, Amaya EO, Marshall J, Sandercock PAG, DeIUlISM, Warlow CPo Acute stroke ~bnent in UK hospiWs: the Stroke Association survey of consultant OpininlL
1997;314:1059-60.(12
.t
,ey.
would
be
asked
to
pay
for
the
Its merits, with the appropriate presence of :-1: ed ..3 uuorm consent representmg an nnporbut not paramount, consideration. e publishing
mvestI~tIo~ lose their
Those licence and only
~ho. refused would livelihood The lan
P
was abandoned others when
recently,
though about
I and
les
he nd utur.
Th
B"4"T' ..jRCoUPhysiiansLond1995;29:479-84. 1Y';J S present policy of sometlmes 4 Ricci S,Celani MG, Righetti E, Cantisani AT for the Interresearch in which patients have natina;l ~troke Trial Col1aborati~eGroup. Between couninformed consent is indeed ~ ~bons ;'&~ ~ ~9~6~6(s~p1 ~):133. of m~~=: stract. fO;;.. acute ei!5es
expressed concerns . It was first proposed
the ethics
not ~ven fully wholly correct.
Peter Wilmshurst Royal Shrewsbury
Consultant cardiologist HospitaI, Shrewsbury SY3 8XQ
d
n 19s .th I. )li,in w he n
Mar
...5 k F G Hulbert ~enWT regIStrar m ophthalnwlogy Moorfields Eye HospltaI, London EC 1 V 2PD
WarlowC, Van GijnJ,SandercockP,edSo SlrokemOOuleoJIhl Cochranedatabase oj ,rystematic reviews {updated4 Mmrh 199n Oxfonl: Update Software,1997. (Updated quarterly.) ..2 Subjects may be coerced participating in studies
1 DoraJ L Journals should not poblish research to which paben~ have not given fully informed consent-with three 2 exC':PbOns.B}.f(1997;314:1107-11.(12April) .., TobIas J. BMJ s present policy (somebmes approVIng research in which patients have not given fully informed consent) is wholly correct BMj 1997;314:1111-4. (12 April.)
mto
no
EDITOR-Whether prospective li ..4 exp at statement about sent should be published
research informed
WIth con-
1 Smith R. Informed consent: the intricacies. BMJ '1997; 314:.1059-60.(12 April) . AdkissonGH,MacleodMA,HodgsonM,Sykes]W,SmIth F, Strack c. etaL CerebioalpeIfusion deficits in dysbaric ilIness.Lmu:et 1989;ii:119-22. 3 Wilms~u.rstPf,NunanTO..~erebmperfusiondeficitsin dysbanc illness.Lmu:et1989;n:674-5. Adkisson GH. Cerebral perfusion deficits in dysbaric illness. Lancet1989;ii:675. \l-\<6' 5 Wilmshurst P. Ethical or not? Diver 1992;37(9):85. ~
is an issue avoided
"M"""""
tters
The whole population must be mobilised e war a~t cancer EDITOR-EthiCISts should carefully avoid absolutism lest they become hostages to fortune. Len Doyal, an ethicist whom I much admire, has fallen into this trap. I For example, he statesand restates his belief that it is unacceptable to compromise individual rights, eveniftl1e publicin~estdernal1dsit 1 presumetherefore~a~ he IStoo young to remember the conscnptlon that was necessary to fight a just war against the Naii powers: th~ very ones guilty of the worst atrocities committed in the name of mediCal science, Cancer commits atrocities on the human lJ;ody,and the fight against cancer has often been likened to a war: 'The war against disease and for health cannot be fought by physicians alone it is a people's .war in which the entire population must be moblised permanently:'! If there is to be a war against cancer and if it is considered unethiCal to conscript patients as the foot soldiers in this war, then it is up to the lay public to recognise their responsibilities to society on a voluntary basis, in addition to demanding their rights of autonomy and progress for the treatment of malignant disease, It was precisely that argument that I described in my paper in the Lancetin 1993,! which was inappropriately cited by Doyal to support his argument about accessto mediCal records, I am glad to report that many women with breast cancer have risen to this challenge,!' and we now have a consumer's ad~sory group of committed lay women chaired by Hazel Thornton who see themselves as equal stakeholders in the fight a~t cancer. Until we have permanently ~obilised the whole population in this war the agonising debate about the process and ethics of informed consent will continue to thunder on and on. In the meantime in a less than perfect world I have to sid: with Jeffrey S Tobias,who like me, every day ofhis working life, has to make these tough decisionS,' It would help the debate if the armchair ethicists got down from their ' . veran das and mIXed WIth the natlvesperhaps first hand experience would dilute , .,
~ '1
,
.m
th
.
obtained I Little attention has been paid to ha ' w t patIents understand that they have consented to. " We rep?rt pr~,ary da~ from a study of 102 patIents receIVIng radiotherapy for canc~, ~wenty two per .cent (22/99) had no recollectIon of consen~g t~ the procedure (all had consented), Thirty SIXper cent (29/ 80) of those who did recall conse~~g thought that th~yhad cons~nted..to any proc~dure,that the doctor thinks. Isnecessary mclu~g chemotherapy,.radiotherapy; orsurgery, Mo~eover,60% (48/80) thought that by consenting they had undertaken to accept "any side effects caused by the treatment," and 44% (42/95) believed that by consenting they ,would be unable subsequently to complain ~out side effects. Clearly, the issue of informed consent implies a sharing of information, yet 2~% (24/99) of our sample could not recall be~g told about any side effects from radiotl1erapy, not even common effects such as ?uming skin or tiredness,of w~ch they were informed Th~se were ~ patl~ts who had had an appomtment, WIth their ,consultant when treatment options and side effects were, discu-:sedfollo,:"ed by a pre~ent meeting WIth a radio.grapher, ~ ad~tion, 60% (54/90) of patients received infor~~on leaflets and 47 out of 100 sawa speciallSt, cancer c?unsellor on at l,e3;Stone OCcasiOn. patients are not retammg the If information that they have been provided with, or if they are misun~erstandirig preCISelywhat they are consen,tlng to they are bein!? ill ,equipped to ,make the psychologl:cal adJus':Inentthat will be necessary through~ut the~ tre.atment Our findings highlight the n;eed for more research ,t~ b~ conducted mto the process for O?tammg ~ormed consent and ,:"hether ..patle?ts take m and ~ders~d informatIon gl:ven to them, If the subject has not taken in the information then their cons~n~ is h~dly info~ed It ,ma~ be ~at the tlmmg of ~o~atlo? sharmg IScru~ as to whe~er It IS retamed and that this should be VIewedas more of a process than a one off event Char.esMontgomerySenlOr .1 '" regIStrar psyw_. J m ,I.on"" WonfordHouseHospital, ExeterEX2 5AF ,
Anna Lydon SenIOr regIStrarm;clmical oncology Devon and Exeter HospItal, Exeter EX2 5DW
Keith Uo d Senior lecturer .,Y. Umverslty of Exeter, Postgraduate Medical School
Department Hospital, of Exeter Mental EX2 Health, 5AF Wonford House
area of clinical in terp ersonal CO rnrn
'
tion. N~where in either article is this fundamental ISsueclearly addressed, My experience of dealing with research protocols from a wide range of SOurces some of them extremely august, leads me to' the reluctant conclusion that the last feature to be tackled by a researcher is the means b which the nature .of therese~ch Will b~ m~de comprehensible to potential subjects. It ~ notunc~mmon!or the loCal research e~cs C?mInlt~ to have to rewrite the patlentinformation and consent literature for the applicant, and this is a COmmon source of delay in obtaining approval, Even when the written material is deemed acceptable the diverse nature of tl1e circwnstances and abilities of research subjectsdemands a personal presentation of the informat...