Culture of subterfuge

February 26, 1999

The North Staffordshire baby deaths highlight the need for more support for medical ethics committees, says Richard Nicholson

"Babies twice as likely to be brain-damaged by experimental ventilator" could have been a headline last week on stories about a government inquiry into clinical trials in North Staffordshire.

The pressure for the inquiry comes from parents whose premature babies were enrolled in a clinical trial at North Staffordshire Hospital, Stoke-on-Trent, in the early 1990s. They claim they did not give informed consent for their babies to take part. One couple, Debbie and Carl Henshall, has spent five years assembling a dossier of evidence after one of their babies died and another was severely brain damaged.

That dossier has convinced both the General Medical Council and the junior health minister, Baroness Hayman, to set up inquiries, the first into the conduct of several doctors at the North Staffordshire Hospital, the second into the supervision of clinical trials there.

The response of the North Staffs NHS Trust to the second inquiry is curious. It claims it holds consent forms for all 244 infants included in the trial and that those who received continuous negative extrathoracic pressure (CNEP) in a reduced-pressure tank around their bodies, did as well as infants ventilated by conventional means. Although the outcome scores were weighted arbitrarily and the scoring system was not validated, the trust still claims that both groups did equally well.

Outcomes likely to be of concern to parents were listed as "secondary outcome measures". Mortality rates, for instance - 23 per cent of infants on CNEP died compared with 18 per cent of those treated conventionally. The only measure of brain damage was abnormalities of cranial ultrasound: 12 per cent of CNEP infants and 8 per cent of controls had such abnormalities. But parents of CNEP babies now know of at least five more babies whose brain damage only became apparent later.

From a parent's perspective, the assurance by North Staffs NHS Trust that CNEP babies did as well as controls does not ring true. Moreover, the claim that all parents signed consent forms does not explain why, after six months, the GMC inquiry still has not had access to those forms.

Clinical researchers often complain that it takes ten years for research findings to filter into routine clinical practice. This is swift compared with the time it takes for changing ethical standards to be noted by researchers. The Nuremberg Code was written just over 50 years ago. It starts: "I the voluntary consent of the human subject is absolutely essential ...", but that injunction was ignored by doctors for 20 years. A similar requirement is in the 1975 version of the Helsinki Declaration, now accepted as the basis for the ethical conduct of research. Only very stubborn researchers would not know that the consent of patients to research is mandatory.

One possible contributory factor to the apparent shortcomings at North Staffs is specific to the hospital's paediatric unit. Just as it is one of the only units in the world that still uses CNEP routinely to ventilate older children in intensive care, so it is one of the few units to undertake much covert video surveillance of parents suspected of abusing their children. Parents are not told they are being observed by a hidden camera.

When such surveillance is carried out for several years, one wonders whether it may breed a more ready acceptance of subterfuge, a sort of "culture of we know best". For it is not only in the CNEP trial that parents claim not to have been told about research. The information sheet given to parents of babies exposed to low oxygen levels in another trial that caused an outcry last year failed to refer properly to the risks involved. Yet the trial's purpose was to recreate the conditions of long-distance flight - which it was thought might contribute to infant death.

Ignoring informed consent, and deceiving parents, should be prevented by having a research ethics committee (REC) review all proposals for research on people. Such a review should include both the scientific value of the research and the information to be given to patients and form of consent obtained from them.

North Staffordshire is unique in having both a scientific merit committee and a research ethics committee. There is a danger of responsibility falling between the two, which is why all other RECs work on the basis that science and ethics must be reviewed together. Perhaps it is significant that over two years in the early 1990s, not one of the 325 proposals reviewed by North Staffs was turned down. Comparable committees would have rejected five to eight proposals. Yet this week the local health authority is considering a proposal, arising from a local review, to continue with the same system.

Local responsibility for preventing research problems lies with the institutional leadership - the trust board and senior managers. Neither inquiry will necessarily reveal why they failed to act but the reasons need exploring. Research can make a substantial contribution to a trust's income: were the trust leaders unwilling to put that income at risk? Was the hospital, as a recent addition to Keele University, also under pressure from the university to achieve high scores in the research assessment exercise?

Personal and institutional reasons may have contributed to the North Staffs mess, but so may the Department of Health. To work effectively RECs,whose members may give 200 hours unpaid each year, need support. The department has known this for 15 years, since I did the first major survey of RECs, but has done nothing. There are still RECs with no allocated administration time or budget. And on the training side, DoH has not implemented the findings of a 1992 report it commissioned.

Yet it is with the Department of Health that the greatest chance of improvement lies. Curiously, a review of RECs was already underway: set up by the previous chief medical officer 13 months ago and conducted by civil servants with no external input. Hopefully this week's ministerial interest in how these committees function may shake civil servants out of their lethargy over what the committees need to do their job properly.

Richard Nicholson is editor, Bulletin of Medical Ethics.

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