Eligibility

A study is eligible for participation in the scheme if the condition of interest is a rare childhood infection or disorder (or a rare complication of a more common disease) of such low incidence or prevalence as to require ascertainment of cases on a national scale in order to generate sufficient numbers for study. The BPSU Executive Committee may also consider inclusion of short-term or geographically limited studies of comparatively more common conditions.

Consideration of suitability takes into account:

• the public health and scientific importance of the study
• the feasibility and acceptability of the methodology to be employed
• whether the BPSU is the most appropriate means of ascertainment
• whether there are mechanisms for validation. Studies depending on reporting of patients immediately after admission, for example, are generally less suitable, although arrangements for immediate reporting by telephone have been made for some studies.

Studies must have

• relevant ethical approval before they can commence
• Patient Information Advisory Group approval
• proof of adequate funding and organisational arrangements to achieve the investigators' objectives

Studies will not usually be considered if they are

• Expecting more than 400 cases a year
• Clinical trials
• Case control studies
• Developing a registry
• Requiring long-term follow up
• Requiring retrospective reporting

There is a two phase application procedure to the BPSU. Phase 1 requires the completion of a two side application form, see Phase 1 Application/Guidelines. If approved a more detailed Phase 2 application will be sought, see Phase 2 Applications/Guidelines.

The list of conditions is reviewed regularly. Studies are accepted for an agreed period, which may range from a few months up to several years, with continuation, subject to review.

Applications must be submitted at least a month prior to the date of a BPSU meeting.

Richard Lynn, Scientific Coordinator
Tel: 020 7323 7911 or
E-mail: bpsu@rcpch.ac.uk

Richard will be happy to discuss protocols at the design stage.