Research ethics committees: a comparative study of assessment of ethical dilemmas

Abstract

Research ethics committees (REC) constitute an important instrument for the regulation of biomedical research involving human beings. The purposes of this work were to study the ethical reasoning in RECs and to ascertain whether the composition of RECs has any bearing on the decisions subsequently made by them. We used a postal questionnaire, containing authentic cases of research ethical dilemmas, sent to the ten RECs in Sweden (n=124) and to comparison groups consisting of 200 randomly selected medical researchers, 200 randomly selected healthcare politicians and 200 randomly selected district nurses. The average response rate was 68%. A difference was found in how REC members assess a project in comparison with researchers, healthcare politicians and district nurses. Differences depended on the type of project assessed. The study indicates that membership in RECs may exert a normative influence on its members. It is proposed that this investigation should be followed up by a study with a qualitative design.

Keywords

empirical ethics ethical reasoning informed consent research ethics committees.

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