Should the BMJ reject all studies
that do not include informed consent? That's a simple question, and
surely the answer should be equally simple-"Yes."
Unfortunately,
ethical questions rarely allow simple answers, and we want help with
answering this one. This issue includes a cluster of material that
relates to the question. We publish the material - including two studies
in which informed consent was not sought - to encourage debate and to
arrive at a deeper understanding if not a simple answer.
Medical journals must consider the ethical aspects of all the
material
they publish, and medical editors are presented with ethical issues
just as often as doctors - that is, every day. Almost everything that
doctors and editors do has an ethical aspect. However, a paper
published last month in JAMA shows that many journals do
not give their authors clear ethical guidance.(1)
A survey
of the published instructions to authors of the 102 major English
language biomedical journals showed that a quarter did not give authors
any guidance on human research ethics, and only half required approval
by an ethics committee or institutional review board before
publication.
An accompanying editorial looked at 53 consecutive research papers
published in Annals of Internal Medicine,
BMJ, Lancet, JAMA, and
New England Journal of Medicine.(2) The
authors found that 47% did not record informed consent and 58% did
not record approval by an ethics committee or institutional review
board. Importantly, they found six papers in which they judged there
was a compelling need for informed consent or approval by an ethics
committee or institutional review board and yet where there was no
mention of either. These data are supported by a study that found that,
of 586 interventional studies published in four geriatrics journals,
only 54% included informed consent and 40% included approval by an
ethics committee or institutional review board.(3)
The
JAMA editorial recommends that journals explicitly ask
authors to state that their research complies with the World Medical
Association's Declaration of Helsinki.(2)
The Declaration of Helsinki includes four paragraphs specifically on
informed consent and does allow physicians sometimes to do without
informed consent in the context of "medical research combined with
professional care (clinical research)."(4)
The first
paragraph states: "In any research on human beings, each potential
subject must be adequately informed of the aims, methods, anticipated
benefits and potential hazards of the study and the discomfort it may
entail. He or she should be informed that he or she is at liberty to
abstain from participation in the study and that he or she is free to
withdraw his or her consent to participation at any time. The physician
should then obtain the subject's freely given informed consent,
preferably in writing." The next two paragraphs consider patients
in
a dependent relationship with physicians or who are not legally
competent. The "let out" paragraph says: "If the
physician
considers it essential not to obtain informed consent, the specific
reasons for this proposal should be stated in the experimental protocol
for transmission to the independent committee."
Both the studies that we publish comply with the Declaration of
Helsinki. Both were approved by ethics committees. Those committees
agonised over the studies, and both papers include a detailed account
of why the researchers did not obtain fully informed consent. But
should the BMJ set a higher - or at least more
explicit-standard than the Declaration of Helsinki?
One of the studies, from Edinburgh, is a randomised controlled trial
of
whether stroke family care workers improve outcomes for patients with
stroke and their families (p 1071).(5) The
authors
decided against seeking consent for randomisation primarily on the
grounds that a detailed knowledge of the trial and its exact purpose
would bias outcomes, which were essentially subjective. In addition,
they did not expect the intervention to be harmful, and patients and
their families could decline to see the stroke family care worker
(p 1077).(6) Sheila McLean, a professor of law
and
ethics in medicine, argues that their reasons are insufficient to
justify deviation from the general rule that good research must at all
times respect the subject (p 1076).(7) "Any
failure,"
she writes, "to offer this respect is in itself a harm, even if its
consequences are not physical."
The second study, from South Africa, was a prospective double blind
study of whether infection with HIV affected the outcome of patients
admitted to an intensive care unit (p 1077).(8)
This is
an important question because when resources are tight there is a
tendency not to admit patients infected with HIV to intensive care
units. Patients did not give consent to be in the study or to have
their blood tested for HIV. The authors argue that consent could not be
obtained from most cases because they were too sick and that the
research was of such importance that the patients' right to informed
consent could be waived (p 1082).(9) The chairman
of the ethics committee explains why the committee supported the
research after its immediate reaction that it would not be possible to
give ethical approval (p 1083).(10) The
explanations
include the facts that the study entailed no interventions of any sort
different from those that are necessary and are carried out in standard
intensive care and that the injury done to the patients would be small.
Rajendra Kale, an Indian neurologist, argues that the ethics committee
was wrong to approve the research and that the BMJ is
wrong to publish it (p 1081).(11) He thinks that
such
research would not have been allowed in a fully developed country and
worries that it may be too easy to flout fundamental human rights in
the developing world.
The editors of the BMJ and our reviewers were divided on
whether we should publish these papers. In the end we decided-and I as
editor must accept full responsibility - that, rather than restrict the
debate to ourselves, we would do better to invite our readers to join
in. We are thus publishing the papers together with their commentaries
and with an argument from Len Doyal, a professor of medical ethics,
that the BMJ should not in future publish papers like
these (p 1107).(12) He proposes a policy that
all
medical journals might follow.
Professor Doyal writes that "Our abilities to deliberate, to
choose,
and to plan for the future are the focus of dignity and respect which
we associate with being an autonomous person capable of participation
in civic life." To deny patients participating in research full
information on that research is, he argues, a clear breach of their
moral rights. Professor Doyal then examines the arguments against fully
informed consent: patients may be distressed by detailed information;
it may not be necessary when the risks of the research are negligible;
and the interests of the public in medical progress will be undermined
by too much emphasis on the rights of individual patients. He finds all
these arguments unconvincing.
But he does identify three sets of circumstances in which informed
consent may not be necessary. So long as a set of conditions are met
then research may be allowed without consent on patients not competent
to give consent - including children, patients with learning
difficulties, and unconscious or semiconscious patients. Otherwise,
such patients will be denied the benefits of research. Secondly,
epidemiological research on medical records may be acceptable in
certain strict circumstances when, for practical reasons, consent
cannot be obtained. Thirdly, research without informed consent may
sometimes be acceptable on stored tissue from anonymous donors.
Jeffrey Tobias, a radiotherapist argues that the
BMJ is right sometimes to publish studies where patients
have not given informed consent (p 1111).(13)
His
argument revolves around the facts that patients trust their doctors
and that what is clear in "fine and lofty places" like the
letters
pages of medical journals is much less clear in the "real
world,"
where "the doctor must somehow juggle the multiple responsibilities
of expert, humane, and above all respectful support for the patient ...
with the wider healthcare concerns and requirements of society as a
whole."
The patient's voice is heard in this debate from an anonymous patient
who was included in 1987 in a British trial of a new radiotherapy
protocol for cervical cancer without being asked for fully informed
consent (p 1134).(14) She suffered severe
consequences
from the treatment and later discovered that she was one of many
patients who had been included in trials without consent. She feels
abused and quotes another patient who wrote: "Somewhere, somehow, I
have to expose this abuse of power. The doctors never got my informed
consent. This is abuse of society's most vulnerable people. Where is
there a platform for my voice to be heard, to make the public aware and
the establishment accountable?" Our anonymous patient is against
the
BMJ publishing any trials that do not include informed
consent.
Also in this issue, a news report from India describes how the Indian
Council of Medical Research approved research that, without written
informed consent, left women with precancerous uterine cervical lesions
without treatment to study the natural course of the condition
(p 1065).(15) And a second news report describes
how the
Council of Europe is developing a legally binding set of rules on
bioethics. These stipulate that research can be carried out only if
subjects have given informed consent (p 1066).(16) The
rules do not have a "let out" clause to waive informed consent
in
people able to give consent, but they do allow research without consent
in some circumstances in those who do not have the capacity to consent.
These are not easy issues, but we cannot avoid them. Researchers are
likely to continue to want to do trials that do not include fully
informed consent, ethics committees will be asked for their opinion,
and medical journals will be offered the results to publish. The
Declaration of Helsinki does not provide sufficient guidance, and the
BMJ needs your help. Should we adopt the policy proposed
by Professor Doyal or a version of it? Or should we continue sometimes
to publish papers that do not include consent?
Richard Smith
Editor
References
1 Amdur R J, Biddle C. Institutional review board
approval and publication of human research results. JAMA
1997;277:909-14.
2 Rennie D, Yank V. Disclosure to the reader of
institutional
review board approval and informed consent. JAMA
1997;277:922-3.
3 Rikkert M, ten Have H, Hoefnagels W. Informed
consent in
biomedical studies on aging: survey of four medical journals.
BMJ 1996;313:1117-20.
4 Declaration of Helsinki. BMJ
1996;313:1448-9.
5 Dennis M, O'Rourke S, Slattery J, Staniforth
T, Warlow C.
Evaluation of a stroke family care worker: results of a randomised
controlled trial. BMJ 1997;314:1071-6.
6 Dennis M, O'Rourke S, Slattery J, Staniforth
T, Warlow C.
Commentary: evaluation of a stroke family care worker: why we didn't
ask patients for their consent to be randomised. BMJ
1997;314:1077.
7 McLean S. Commentary: not seeking consent
means not treating
the patient with respect. BMJ 1997;314:1076.
8 Bhagwanjee S, Muckart D, Jenna PM, Moodley P.
Does HIV status influence the outcome of patients admitted to a surgical intensive
care unit? A prospective double blind study BMJ 1997;314:1077-81.
9 Bhagwanjee S, Muckart D, Jenna PM, Moodley P.
Commentary: why
we did not seek informed consent before testing patients for HIV.
BMJ 1997;314:1082-3.
10 Seedat Y K. Commentary: no simple and
absolute ethical rule
exists for every conceivable situation. BMJ
1997;314:1083-4.
11 Kale R. Commentary: failing to seek
patients' consent to
research is always wrong. BMJ 1997;314:1081-2.
12 Doyal L. Journals should not publish
research to which patients have not given fully informed research-with three exceptions.
BMJ 1997;314:1107-11.
13 Tobias J S. BMJ's present policy
(sometimes approving research in which patients have not given fully informed
consent) is wholly correct. BMJ 1997;314:1111-4.
14 All treatments and trials must have informed
consent.
BMJ 1997;314:1134-5.
15 Mudur G. Indian study of women with cervical
lesions called
unethical. BMJ 1997;314:1065.
16 Watson R. European bioethics convention
signed. BMJ
1997;314:1066.
