VITAL new guidelines on the rights and wrongs of medical research involving human beings have been overseen by a Gwent doctor.

Professor John Saunders, consultant physician at Nevill Hall Hospital, Abergavenny, chaired an expert Royal College of Physicians team through the two-year task of updating the college's renowned guidance.

He hopes it will prove essential reference for anyone planning research in medical and pharmaceutical fields, and for members of around 200 UK research ethics committees, which regulate such work.

"The aim was to produce concise, comprehensive and understandable guidelines. I believe we have produced the best available, certainly in the UK," said Professor Saunders, also Gwent Healthcare Trust clinical director for diabetes.

Implications of advances in medicine and pharmaceuticals in the 11 years since the college's previous guidelines prompted a complete rewrite.

The new publication covers a vast range of issues, including drug trials, research involving specific groups of people, from healthy volunteers to children, learning disabled, the elderly, pregnant or potentially fertile women, and refugees.

Also addressed is use of medical records, human tissue and tissue records, placebos in drug trials, and areas as diverse as genetic research, devices for administering drugs, communication issues, and payment for taking part in or conducting research.

"We've also included guidance on use of the internet, for instance in recruitment into research, and attempted to address complementary and alternative therapies" said Professor Saunders.

"Whether we agree with them or not, they are widely used by patients and also by some doctors."

Research ethics committees (RECs) comprise one third medical, other professional, and lay membership, and consider whether or not research involving humans can go ahead.

"I hope this guidance will be in the hands of every REC, along with research units and anybody planning research in the pharmaceutical community," said Professor Saunders.

"Every item of research involving human beings or their records or foetal material must go through an REC, along with all research involving drugs. Drug trials take up about 20 per cent of the research ethics workload."

THE guidance, said Professor Saunders, is produced from the position of a strong belief in the value of ethical research.

"We should not be neutral about whether we do it or whether people take part in it. From a moral point of view, ethical research is a good thing," he said.

Another Gwent physician Dr Mike Shooter, was also involved in work on the guidelines and Professor Saunders said there had been a strong Welsh contribution.

"The guidance itself is subject to formal review and though there has only been one so far, it was extremely positive.

"I hope it will go across Europe, because there is no similar guidance in most European countries," he said.