RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of March 28, 2008 No. 55

About approval of the Regulations on committee on ethics

Based on article 15 of the Law of the Republic of Belarus of July 20, 2006 "About medicines" the Ministry of Health of the Republic of Belarus DECIDES:

1. Approve the enclosed Regulations on committee on ethics.

2. This resolution becomes effective after its official publication.

Approved by the Resolution of the Ministry of Health of the Republic of Belarus of March 28, 2008 No. 55

Regulations on committee on ethics

1. This Provision determines procedure for creation and work of committee on ethics (further – committee).

2. The committee is created under the state organizations of health care as advisory council.

3. In the work the committee is guided by the basic international principles of carrying out clinical testing of medicines, the legislation of the Republic of Belarus, this Provision.

4. Main objectives of Committee are:

consideration of questions of providing the rights, safety and health protection of the patients participating in clinical testing of medicines (further – patients);

approval of the program (protocol) of clinical testing of medicines;

assessment of qualification of researchers who will carry out clinical testing of medicines, and availability of conditions in the state organizations of health care for carrying out clinical testing of medicines.

5. According to the assigned tasks the committee carries out expert evaluation of the following documents:

programs (protocols) of clinical testing of medicines;

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