[Activity of ethics committees in clinical trials of antibacterial drugs].
Clinical trials are designed and conducted worldwide in accordance with International Rules of Good Clinical Practice (GCP). The guidelines are aimed at establishing a system ensuring personal integrity and welfare of trial subjects. A significant point of the activity of Ethics Committees in GCP is protection of trial subjects. The experience of the local Ethics Committee of the Smolensk Medical Institute with protection of clinical trials of antibacterials is presented. The importance of setting up Ethics Committees for supervision of clinical trials in Russia is emphasized.
Melikhov
O G
OG
Strachunskiĭ
L S
LS
D000890:Anti-Infective Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D017041:Ethics Committees; D006801:Humans
D000890:Anti-Infective Agents
Deiatel'nost' éticheskikh komitetov pri klinicheskikh ispytaniiakh antibakterial'nykh sredstv.