Local research ethics committees' approval in a national population study.
BACKGROUND
Epidemiological research using patient records faces considerable uncertainty regarding requirements for local ethical review, confidentiality of data and patient permission.


METHODS
We report the experiences of the national study of clustering and geographical variation in anophthalmos and microphthalmos, which, from 1994, has been compiling a register of affected children born in England since 1988. The information is obtained from clinicians and local health authority records without any direct contact with patients or their families.


RESULTS
Of 110 district health authorities, 47 required ethical approval. Only one committee accepted the approval of any other committee. Procedures and application forms varied widely. Fewer than one-fifth of the forms completed asked about compliance with the Data Protection Act, yet confidentiality safeguards must be the foremost ethical issue faced by the study. Two committees required that the study inform GPs and two committees required that the study obtain parental permission.


CONCLUSIONS
While new mechanisms including regional committees are being established, there is an urgent need for a standard application form to save time and resources for research. Continuing lack of consistency about the need for subject (parental) permission impedes the proper design and costing of research.
Busby
A
A
Environmental Epidemiology Unit, London School of Hygiene and Tropical Medicine.
Dolk
H
H
D000853:Anophthalmos / Q000453:epidemiology; D002648:Child; D003219:Confidentiality; D004812:Epidemiologic Methods; D004992:Ethics, Medical; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007258:Informed Consent; D008297:Male; D008850:Microphthalmos / Q000453:epidemiology; D010344:Patient Advocacy; D011159:Population Surveillance / Q000379:methods*; D011367:Professional Staff Committees / Q000458:organization & administration*; D012042:Registries; D012106:Research / Q000458:organization & administration / Q000592:standards*; D006113:United Kingdom