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Friday, 19 February, 1999, 11:49 GMT
Regulating medical research
Premature baby
There is controversy over clinical trials involving premature babies
The system for controlling the medical testing of new drugs and treatment has been tightened in recent years following concerns that it was not tough enough.

However, the system is likely to come under the microscope again following allegations by parents of premature babies that doctors at the North Staffordshire Hospital in Stoke On Trent tested a new type of ventilator on their children without obtaining proper consent.

The government has ordered an inquiry into the trial which was carried out on 122 premature babies between 1989 and 1993. It is reported that 28 of the children died and 15 suffered brain damage.

Critics of the current system point to the fact that while laws controlling animal research has been in place for 100 years, medical research on humans is not covered by legislation.

In the UK, every medical research proposal must be vetted and approved by a local research ethics committee (LREC). These committees are set up on an ad-hoc basis and are made up of a mix of medical professionals and lay people, usually including at least one lawyer.

The LRECs do not carry the force of law, but in practice it is virtually impossible to obtain financial support for a study that does not have LREC approval.

LRECs are responsible for assessing the possible risks of the research to patients against the potential benefits.

The committees also have to bear in mind that not all research is carried out solely to benefit patients. Some may be designed to generate income for further research or as part of medical training.

The LREC system was overhauled following a 1992 study by the independent health charity The King's Fund, which found unacceptable levels of variation in how the committees were set up, and how they operated.

In response to the King's Fund criticisms, the Department of Health issued detailed guidance to which LRECs are expected to conform.

As a result LRECs are now more likely to find themselves legally liable should a court find that a committee had failed in its regulatory role.

The system has also been strengthened by the introduction of European Union regulations which tightly control the way pharmaceutical companies can conduct research

However, critics of the system claim that committees are run on a shoestring, and without national training there is a risk of bad decisions.

Dr Richard Nicholson
Dr Richard Nicholson says some committees are maverick
Dr Richard Nicholson, editor of the Bulletin of Medical Ethics, said: "It is quite clear there are maverick ethics committees around the country because they have had to work by themselves without proper support for so long.

"It is inevitable that some have developed idiosyncratic ways of working.

"There are some committees were over half the decisions are not even taken by the committee, but are just taken by the chairman alone. This is quite unacceptable."

Patient consent

Although the system for approving medical research has been tightened up, there are still concerns about the issue of patient consent.

The Department of Health and the British Medical Association advise that written consent should be required for all research.

The General Medical Coucil also has the power to strike off doctors who flout its requirement to seek consent.

But there is no legal requirement for doctors and researchers to seek consent, and there are fears that consent can easily be obtained without patients fully understanding all the implications of the research.

Most patients who have tried to establish legal liability through common law have been unsuccessful.

Dr Michael Wilks
Dr Michael Wilks said obtaining informed consent was vital
Dr Michael Wilks, chairman of the British Medical Association ethics committee, said: "Clearly we would expect any team of doctors doing any kind of medical research to get valid and informed consent from patients.

"That means that they have explained the possible benefits of the proposed treatment, the risks, and what would be the consequences of not receiving the treatment.

"If we are talking about research it is also important that the doctor must get across the fact that there is an uncertainty about the possible outcome of the treatment."

Dr Wilks said there had been cases where patients had claimed that they were not told all the facts about a treatment.

"What is important is that the patient is given all the relevant information at the time," he said.

"It may well be that a patient with the benefit of hindsight will say they were not given all the facts.

"But it is important to remember that not all the facts may have been available at the time - that is the whole point of doing the research in the first place."

Vanessa Bourne
Vanessa Bourne called for new consent forms
Vanessa Bourne, from the Patient's Association, said standardised consent forms should be issued throughout the NHS.

She said: "The problem with the forms is that they are very old, and they are not uniform throughout the NHS. Any hospital can have whatever form it likes.

"Some sort of uniform and modernised consent form based on truly informed consent would be a very good thing."

Ms Bourne said the system should be changed so a patient advocate could advise on whether to give consent.

See also:

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