Document submitted for Royal Free ethics approval shows clear intent for research

This page is research from an investigation by Brian Deer for The Sunday Times of London and the UK's Channel 4 Television into a campaign linking the MMR children's vaccine with autism. | Go to part I: The Lancet scandal | Go to part II: The Wakefield factor

Following Brian Deer's investigations, Andrew Wakefield threatened to sue him, claiming, among other things, that a paper published in the Lancet on February 28 1998 was not research. This is notwithstanding Wakefield describing himself in the paper as "the senior scientific investigator". Through lawyers, threatening to sue Deer, he said: "In contrast to a clinical research study requiring ethical approval, the Early Report was a report of clinical findings of tests which had been performed solely on the basis of clinical need." The Royal College of Physicians has considered this distinction, and says the determinant is the intent behind the project

The document below, one of a mass of papers obtained by Brian Deer - including a protocol pro-forma and a full protocol - makes no mention of any clinical benefits for the participating children. Instead, it sets out its intention purely in research terms. It says: "We would like to carry out a series of tests which, we believe, will help us to establish the features of this possible disease. Our aim is to characterise the problem so that, for the future, we may be able to treat affected children and improve their wellbeing"