§ Dr. Evan HarrisTo ask the Secretary of State for Health how he has satisfied himself that lumbar punctures carried out on children at the Royal Free Hospital by the Inflammatory Bowel Disease Study Group since 1996 have had valid and explicit ethical approval from a properly constituted research ethics committee on the issues of full disclosure of the research's relevant interests and of the full clinical context. [157459]
§ Miss Melanie JohnsonBased on information currently available to us, the Royal Free Ethics Committee approved the collection of data from clinically indicated investigations for a study entitled "Enteritis and Disintegrative Disorder following measles/rubella vaccination" in November 1996. The disintegrative disorder described in the protocol is Heller's disease, and the vaccine under investigation was measles/rubella vaccine.
We also understand that the study title was changed to "Autism and Non-Specific Colitis and Lymophoid Nodular Hyperplasia" and the name change was approved by the Royal Free Ethics Committee in 1998.
The Ethics Committee gave approval for the collection of data from clinically indicated investigations. The Committee did not take a view on which clinical investigations, such as lumbar puncture, were justified. This would usually be determined for each individual child involved, depending on their condition.