Development of an ethical committee and its effect on research design

Abstract

The proportion of research protocols needing modification or given only conditional approval for the Southampton ethical committee increased from 10% in 1971 to 25% in 1975; from 1976 to 1981 36.4% of submissions were referred. The commonest areas needing modification changed gradually from unsatisfactory choice of subjects to inadequate explanation to subjects. Possibility of discomfort, inconvenience, or harm was not mentioned in any protocol in 1971, but was mentioned in 35 in 1975 and 42 in 1979. 76% of projects submitted in 1971, and 71% in 1975 were published in scientific journals. The proportion of projects abandoned increased from 3% in 1971 to 14% in 1975; 16% of projects submitted in 1979 have already been abandoned.

KIE: The work of a British ethical review committee from 1971 to 1981 is reviewed with a focus on the impact of the committee on research design. Reported results include: an increased number of research proposals needing modification, more stringent disclosure and consent requirements, a decline in projects rejected due to problems in subject selection, and an increased awareness among researchers of risks to subjects. Also discussed are composition of the ethics committee, publication of research results, and attitudes of the committee and of researchers.