The first three allegations of alleged research misconduct have been answered by clarifications provided by the senior authors of this work. The wording in the published paper regarding Ethical Practice Committee approval and patient referral was accurate, yet at the same time summarised obviously lengthy and complex institutional and clinical review and referral procedures. In the light of the public controversy surrounding this work and the allegations made to us, one could argue that more explanation could and should have been provided in the original paper. Although, with hindsight, this seems a reasonable criticism, all research papers published by all journals are inevitably concise accounts of often complicated research protocols. We do not judge that there was any intention to conceal information or deceive editors, reviewers, or readers about the ethical justification for this work and the nature of patient referral. We are pleased to have had the opportunity to clarify the scientific record over the matters raised by these serious allegations. We regret that aspects of funding for parallel and related work and the existence of ongoing litigation that had been known during clinical evaluation of the children reported in the 1998 Lancet paper were not disclosed to editors. We also regret that the overlap between children in the Lancet paper and in the Legal Aid Board funded pilot project was not revealed to us. We judge that all this information would have been material to our decision-making about the paper's suitability, credibility, and validity for publication. In considering what sanctions The Lancet should apply, the COPE guidelines3 give eight options in a ranked order of severity. Given the public-health importance of MMR vaccination, together with the public interest in this issue, we have decided to pursue a course of full disclosure and transparency concerning these allegations, the authors' responses, the institution's judgment, and our evaluation.
