Polish Research Ethics Committees in the European Union system of assessing medical experiments

Abstract

The Polish equivalents of Research Ethics Committees are Bioethics Committees (BCs). A questionnaire study has been undertaken to determine their situation. The BC is usually comprised of 13 members. Nine of these are doctors and four are non-doctors. In 2006 BCs assessed an average of 27.3 +/- 31.7 (range: 0-131) projects of clinical trials and 71.1 +/- 139.8 (range: 0-638) projects of other types of medical research. During one BC meeting an average of 10.3 +/- 14.7 (range: 0-71) projects of medical research were assessed (2006). The amendment of Polish laws according with Directive 2001/20/EC caused a percentage increase in BCs which assessed less than 20 projects per year (16% vs. 33% or 42% in 2003 vs. 2005 or 2006 respectively, p < 0,05). The results confirm the usefulness of the current practice of creating BCs by medical universities, medical institutes and regional chambers of physicians and dentists but rationalization of the workload for individual BCs is necessary.