Úloha etické komise při posuzovánígrantů na klinické hodnocení

Role of Ethical Committees on Expertising of Grants

The common feature for all types of clinical research is that it is performed on people - trialsubject (healthy or ill). Other common feature is that the risk, subjects are exposed to, must notbe high. The ethics of clinical research is concerned not only in trials sponsored by pharmaceuticalcompanies, but also in the biomedical research, no matter whether the initiator is aninstitution or clinical investigator.Research is an integral part of a complex expertise of initiatedproject. Ethics Committees (ECs) should expertise whether the expected scientific results arecompetent and whether the project is not self-purposeful. For ethical consideration it isnecessary to come out from the respect and dignity protection, integration, human rights andwelfare of people who undergo the research. These interests must always be preferred toscientific and public interests. An adequate scientific and ethical quality and credibility ofresearch must always be guaranteed. It is necessary to prevent sinister or false procedures.Responsibilities are divided into the initiator, researcher (investigator), respectively his employer,and trial subject, The role of ECs is often reduced to the approval of Informed Consent (IC),nevertheless unethical experiments do not automatically become ethical experiments by that.To expertise the extent of the risk for people as objectively as possible, ECs should especiallyconsider: documentation (protocol), quality and comprehensibility of IC, adequate extent ofinformation for people, quality of insurance and compensation, researcher and site qualification.ECs should everything discuss and decide independently on its establisher, initiator/sponsor,and investigator. Sufficiency of legal norms for the function of ECs already exists also in ČR,although not everywhere are created adequate conditions for their fulfilling. Nowadays ormaybe right today, it is necessary to use science for people, not against them.

Key words:
clinical research - ethical committees.