[Will Polish investigators have access to the research ethics committees?].
Polish research ethics committees (REC) provide opinions on projects of medical research (A), object to participation of regional investigator or center in multicenter clinical trials (B) and provide opinions about amended protocols or documentation of investigated medicinal product, which might change safety of trials' participants (C). Model of self-financing of REC is in force in Poland. Charges collected for opinions should cover incurred costs of REC. Legitimacy of collection of charges for proceedings B and C is questioned due to the dimness of Polish provisions. At the same time the number of submitted to REC projects of medical research decreases but the number of proceedings B and C increases. REC should have and office and secretary. The duty to provide opinions B and C and lack of A proceedings might cause financial collapse of REC. Shortage of assets might deprive investigators of an access to REC. Provisions regulating financing model of Polish REC should be amended.
Medical University of Warsaw, Department of Internal Medicine, Poland. mczark@gmail.com
Marek
M
Czarkowski
D028744:Ethics Committees, Research / Q000458:organization & administration*; D011044:Poland