BMJ

Informed Consent and ResearchAuthor(s): David Benatar and Solomon R. BenatarSource: BMJ: British Medical Journal, Vol. 316, No. 7136 (Mar. 28, 1998), p. 1008Published by: BMJStable URL: http://www.jstor.org/stable/25178732 .

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Education and debate

Informed consent and research

David Benatar, Solomon R 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

Solomon R Benatar,

professor of medicine

Correspondence to: Dr D Benatar

dbenatar@socsci.uct. acza

BMf 1998-316:1008

nw

www.bmj.com

A longer version

of this article is

available on our

website

In the debate opened by the BMJ on whether research

is ethical if it meets the standards of the Declaration of

Helsinki but is conducted without informed consent,

Len Doyal provides some powerful arguments for why

the request for informed consent should be inviolable.1

While vigorously defending the inviolability of informed consent, he concedes that it is not necessary in

certain circumstances. An uncontroversial case is that of

incompetent patients (although even here other

rigorous requirements must be met). However, the other

exceptional cases he mentions seem to have some

unfortunate implications for his defence of informed

consent He thinks that for epidemiological research on

patient records the informed consent requirement may

be waived if certain conditions are met: (a) that access to

the clinical record is essential to the research; (b) that consent is not

practicable; (c) that the research is of suffi

cient merit; (d) that it may benefit the patient whose

records are studied; (e) that, when possible, the research

ers are unable to connect the records with the patient's

identity, but that where this is not possible, patients will

not be identifiable when the results are made public; if) that it is not anticipated that contact will be made with

the patients as a result of research findings; and (g) that

access is restricted to specific categories of information

that have been approved by the local ethics committee.

Professor Doyal thinks that similar conditions should

apply to research on stored tissue from unconsenting

anonymous donors.

The South African HIV study, which Professor

Doyal criticised for not obtaining patients' informed

consent for HIV tests, involved performing a blood test

and not simply viewing records,2 and thus does not

precisely slot into one of his three exceptional catego ries. However, this point does not seem to be a

pivotal issue: one can, after all, have consent to draw blood

without having consent to test it for HIV seropositivity.

Drawing blood without consent would introduce a

problem not permitted by the list of conditions Profes

sor Doyal stipulates, but, assuming that there was con

sent to draw blood, the anonymous testing of that

blood for HIV in the Natal study meets all the conditions enumerated above. Condition (/) lends itself to variable interpretations, but it seems to us that

Il

Are the criteria for informed consent the same in Third World situations as in Western countries?

merely informing patients that they had been subject to an HIV test as part of a

study does not constitute

contact with patients as a result of research findings.

Telling them the result of the test, and counselling for

HIV positive status, would constitute such contact, but

it would be with the consent of the patients. It seems then that Professor Doyal gives with one

hand what he takes with another. He criticises the

South African study for failing to obtain informed

consent, yet this study meets the very conditions that

he thinks he must obtain in those exceptional cases in

which informed consent is not necessary. Trie crucial condition is whether the researcher can

link the medical record to the identity of the patient We agree that informed consent is unnecessary in

research that involves no withholding

or providing of

an intervention and which meets the other conditions

but where the identity of the patient cannot be linked,

even by the researcher, to the medical record. Knowing

that there is an unidentified person who has HIV does

not inhibit that person's autonomy or violate his or her

privacy. By contrast, obtaining the knowledge that an

identifiable person has HIV is an invasion of the

person's privacy if he or she has not consented to this

information being obtained. Thus, the difficult case is

when the researcher gains sensitive information about

a research subject without consent. In such a case

informed consent is important, and if it is to be

overridden a strong argument will have to be made.

Professor Doyal's conditions suggest that he may have

sympathy for the view that die requirement for

informed consent may be overridden in this case, but

his arguments suggest that no such exception should

be made. We can think of no compelling argument for

why an

exception should be made in this case.

What are the implications of this for the Natal

study? The ethics committee and researchers went to

great lengths to ensure that all but one of the research

ers were prevented from connecting HIV status with

the identity of patients. Moreover, all means of linking the HIV tests with the identity of patients were

destroyed at the end of the study. If we are correct that

there are no compelling arguments to justify such

unauthorised violations of privacy, then the Natal study is ethically defective, even though to only a limited

degree. This shortcoming is especially regrettable

given that even the limited invasion of privacy could

have been avoided by encoding patient identity and

thereby ensuring that none of the researchers could

have been able to establish a link between a patient's

identity and HIV status. Even if one thinks that minor

invasions of privacy or other limitations on autonomy

are justified if they can bring great benefits, one must

agree that it is better if these minor intrusions can be

avoided.

1 Doyal L.Journals should not publish research to which patients have not

given fully informed consent?with three exceptions. BMJ 1997;314: 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 BMJ VOLUME 316 28 MARCH 1998

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