Research ethics committee audit: differences between committees.
The same research proposal was submitted to 24 district health authority (DHA) research ethics committees in different parts of the country. The objective was to obtain permission for a multi-centre research project. The study of neonatal care in different types of unit (regional, subregional and district), required that four health authorities were approached in each of six widely separated health regions in England. Data were collected and compared concerning aspects of processing, including application forms, information required, timing and decision-making. The key finding was that ethics committees received and processed the applications variably, reflecting individual factors and local problems. To improve consensus and facilitate multicentre studies, standard forms and instructions are suggested and the establishment of a national committee or advisory group advocated.
Redshaw
M E
ME
Institute of Child Health, University of Bristol.
Harris
A
A
Baum
J D
JD
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D004739:England; D026724:Ethical Review; D017041:Ethics Committees / Q000331:legislation & jurisprudence*; D028744:Ethics Committees, Research; D005260:Female; D033161:Government Regulation; D006801:Humans; D007231:Infant, Newborn; D007258:Informed Consent / Q000331:legislation & jurisprudence; D007872:Legal Guardians / Q000331:legislation & jurisprudence; D008297:Male; D015337:Multicenter Studies as Topic / Q000331:legislation & jurisprudence*; D017283:Neonatal Nursing; D012107:Research Design