The ethics of unlinked anonymous testing

British Medical Journal,  May 6, 2000  by Angus Nicoll,  Noel Gill,  David Goldberg,  Catherine Peckham,  Bernard A Foex,  Anthony Kessel

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Surveys provide essential information

EDITOR--Kessel et al voice concerns about the ethics of unlinked anonymous surveys and the proportion of the public who seem to be aware of such surveys.[1]

The need to use the unlinked anonymous technique for surveillance of HIV was evident once it was appreciated that data from diagnostic testing, or obtained after explicit consent for unlinked testing, inevitably produced biased estimates of the prevalence of HIV.[2] The technique was adopted nationally in 1990 only after extensive consultation and general agreement that, with safeguards, it was legal and ethical.[3] The surveys, which are overseen by the Department of Health, provide information that would otherwise not be available and is essential for planning and monitoring the control of the spread of HIV.[4] They use blood that would eventually be discarded, which is left over after the completion of screening tests in genitourinary medicine and antenatal clinics. Before testing, every specimen is irreversibly unlinked from information that would identify the source individual. Hence infection status can never be traced back to a person. Essentially, the results represent groups in the community and not individuals."[2 4]

Unlinked anonymous surveys in the United Kingdom started only after approval by local ethics committees, and refusals have been rare. Recently, these committees approved extension of the technique for surveillance of hepatitis A, B, and C. Internationally, most countries have followed the United Nations Programme on ADS and the World Health Organization's recommendation to use the technique; only two countries have decided against it.[1]

A door to door survey found that only a third of the general public seemed to be aware of unlinked anonymous surveys, and that only a quarter disagreed with them.[1] People mainly become aware of the unlinked surveys when they attend participating clinics where patients are informed of the surveys by posters and leaflets. Patients who have concerns can discuss them with staff (an option not available in the door to door survey), and the proportion who finally object to their specimens being included is low? The percentage reported to be aware of the surveys is considerably higher than expected. It is higher for adults aged 25 to 54 years--those most likely to have attended a participating antenatal or genitourinary medicine clinic since the surveys began.[1]

There is broad professional and public acceptance of the unlinked anonymous technique. In 1996 the chief medical officer's expert advisory group on ADS reviewed the surveys and concluded again that they were ethical and should continue as they provide essential information on public health.[4]

Angus Nicoll unlinked anonymous programme manager anicoll@phls.nhs.uk

Noel Gill consultant epidemiologist PHLS Communicable Disease Surveillance Centre, London NW9 5EQ

David Goldberg deputy director Scottish Centre for Infection and Environmental Health, Glasgow G3 7LN

Catherine Peckham professor of paediatric epidemiology Institute of Child Health, University of London WC1N 1EH

[1] Kessel A, Watts C, Weiss HA. Bad blood? Surveys of public's views on unlinked anonymous testing of blood for HIV and other diseases. BMJ 2000;320:90-1. (8 January.)

[2] Gill ON, Adler MW, Day NE. Monitoring the prevalence of HIV: foundations for a programme of unlinked anonymous testing in England and Wales. BMJ 1989;299:1295-8.

[3] Heptonstall J, Gill ON. The legal and ethical basis for unlinked anonymous HIV testing. CDR 1989;48:3-6.

[4] Nicoll A, Gill ON, Peckham CS, Ades AE, Parry J, Mortimer P, et al. The public health applications of unlinked anonymous seroprevalence monitoring for HIV in the United Kingdom--a review, Int J Epidemiol (in press).

[5] Joint United Nations Programme on AIDS and the World Health Organization. Report on the global HIV/AIDS epidemic June 1998. Geneva: UNAIDS and WHO, 1998.

Testing need not stop

EDITOR--Kessel et al found that most (69%) respondents to their questions were not aware of the anonymous testing of blood for HIV and other diseases. They also found that 26% of respondents disagreed with the practice of testing.[1]

The authors said that the policy should be reconsidered by the government in the interests of rebuilding confidence in the NHS. They also said that the ethical debate had changed because the HIV epidemic had not materialised. Have the ethical issues changed with time? In 1966 Henry Beecher wrote, "An experiment is ethical or not at its inception; it does not become ethical post hoc--ends do not justify means. There is no ethical distinction between ends and means."[2] For him neither the passage of time nor the results obtained changed the ethics of a study.

Is anonymous testing of blood for HIV and other diseases unethical? Does such a policy breach the four principles of biomedical ethics--namely, autonomy, nonmaleficence, beneficence, and justice?[3] It may be argued that anonymous testing breaches patient autonomy. However, the blood was taken, with consent in the first instance, for a particular purpose. It was used for that original purpose. There is no direct maleficence to the patient from its secondary use. There is no direct benefit either. The policy does not breach the principle of justice: anyone's blood might be used, as would have been the case even if there had been an HIV epidemic. The use of stored tissues for research remains controversial. At least one authority has argued that consent is not needed to use stored tissue, and by implication blood, from anonymous donors for research.[4]