Bioethics Committee is an independent institution which gives opinions and controls the projects of clinical research, created in order to ensure proper protection of human dignity during the studies. Bioethics Committee verifies, among others: legitimacy, feasibility and the plan of clinical studies, analysis of anticipated benefits and risks, correctness of clinical study protocol. Clinical studies cannot be started without Bioethics Committee approval.

Bioethics Committee at Nofer Institute of Occupational Medicine was set up in 2004 by the internal directive of the authorities No. 7/2004. It deals with assessment of medical experiments with participation of people.

Putting forward a proposal to the Bioethics Committee:
In order to obtain opinion of the Committee concerning a medical experiment, an individual or other institution willing to carry out the medical experiment should put forward ‘Motion of expressing opinion on the project of medical experiment’. The proposal is accepted by the secretary of the Committee. Bioethics Committee gives its opinion not later than within 3 months from the date of receiving a complete experiment documentation.

The Committee passes a resolution expressing opinion achieved on the way of voting by secret ballot. More than a half of the Committee, including the chairperson or his/her deputy and at least two members of the Committee who are not physicians must participate in such a voting.
The proposal should include:

– marking the individual or other institution willing to carry out the medical experiment, and in case of a multicenter experiment – also the names of all centers in the country where the experiment is to be conducted,
– the title of the project, its detailed description and argumentation of the usefulness and feasibility of the experiment,
– full name, address as well as occupational and scientific qualifications of the person managing the medical experiment,
– information concerning insurance of individuals who are to participate in the experiment,
– data on anticipated therapeutic and cognitive benefits and possibly any other expected benefits for the individuals subjected to the experiment.

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