LOCAL RESEARCH ETHICS COMMITTEES APPROVAL IN A NATIONAL-POPULATION STUDY

Background: Epidemiological research using patient records faces consi derable uncertainty regarding requirements for local ethical review, c onfidentiality of data and patient permission. Setting and design: We report the experiences of the national study of clustering and geograp hical variation in anophthalmos and microphthalmos, which, from 1994, has been compiling a register of affected children born in England sin ce 1988. The information is obtained from clinicians and local health authority records without any direct contact with patients or their fa milies. Results: Of 110 district health authorities, 47 required ethic al approval. Only one committee accepted the approval of any other com mittee. Procedures and application forms varied widely. Fewer than one -fifth of the forms completed asked about compliance with the Data Pro tection Act, yet confidentiality safeguards must be the foremost ethic al issue faced by the study. Two committees required that the study in form GPs and two committees required that the study obtain parental pe rmission. Discussion: While new mechanisms including regional committe es are being established, there is an urgent need for a standard appli cation form to save time and resources for research. Continuing lack o f consistency about the need for subject (parental) permission impedes the proper design and costing of research.