The Local Ethical Commission of the Semey Medical University, NCJSC was established in accordance with Rector’s Order No. 45 dated 05/17/2006 as an independent body with the aim of effective public participation, including medical, in protecting the rights and health of patients, as well as subjects during clinical trials.

The Commission’s activities are aimed at protecting human rights and dignity, the protection and humane attitude of experimental physicians to laboratory animals.

The Local Ethics Commission should not have a direct interest in a particular study (trial). Regardless of the researcher, the client, the sponsor or the medical institution, the Committee reviews research plans and mechanisms for the protection of human rights and his safety. All departments of the Semey Medical University, NCJSC conducting research on humans are required to interact with the Ethics Commission.

The Local Ethics Commission should not seek profit/benefit as the goal of its activities and should not distribute the resulting profit/benefit among its members and founders. However, the client/sponsor can compensate for the administrative costs, and the payment does not depend on whether the documents are approved or any other decision has been made regarding the study.

The Local Ethics Commission is an open body. Information about its members, work schedule, and all decisions taken is not confidential.

 

The main objectives of the work of the Local Ethics Commission are:

  • protection of the rights and interests of the subjects involved in the study;
  • protection of the rights and interests of researchers.

 

To achieve these goals, the Local Ethics Commission solves the following tasks:

  • conducting high-quality ethical and legal expertise of clinical research materials using new technologies, medicines, food additives, medical equipment and medical devices, new methods of treatment and examination of patients.
  • Assessment of the scientific validity of clinical trials and the expected effectiveness and safety of the studied technologies and medicines.
  • Preparation of conclusions on the feasibility of conducting clinical trials of new technologies and medicines.
  • Regular monitoring of the progress of the study after obtaining permission to conduct it.
  • Notifying researchers and other stakeholders of serious adverse reactions or risks to study participants.

 

Powers of the Local Ethics Commission:

  • The Local Ethics Commission carries out an expert assessment of the researcher’s brochure, the protocol of the clinical trial, information for the patient and the form of informed consent, the professional biography of researchers, research centers and other materials of the clinical trial.
  • The Local Ethics Commission may make the following conclusion based on the results of the examination of the submitted documents and data:
    • To approve the conduct of clinical trials of new technologies, medicines, biologically active substances, medical equipment, materials and medical devices.
    • To approve the conduct of clinical trials with recommendations to make changes and additions to the materials of the clinical trial in a working manner. In this case, the conclusion is issued after answering the questions posed.
    • To postpone making a decision until the comments are eliminated, followed by consideration of the clinical trial materials at the next meeting of the Local Ethics Commission.
    • Do not recommend conducting a clinical trial.

The conclusion is issued to the applicant and sent to the Local Ethics Commission to make a decision on conducting a clinical trial.

In case of disagreement between the applicant and the results of the examination, the Local Ethics Commission re-examines the materials of the clinical trial with the participation of the applicant himself and the involvement of independent experts.

 

Regulation and activities of the Local Ethics Commission

The Local Ethics Commission consists of specialists in the field of medicine, social sciences and humanities, including lawyers, specialists in related disciplines of various genders and ages.

  • The Local Ethics Commission is headed by the Chairman.
  • The members of the Commission are elected for 5 years.
  • The Local Ethics Commission has a work plan, which is developed and approved in accordance with this Regulation.
  • Meetings of the Local Ethics Committee are held in compliance with the quorum.
  • If necessary, the Local Ethics Commission has the right to involve independent experts in the ethical examination without the right to vote, subject to confidentiality.
  • The current results of the work of the Local Ethics Commission are drawn up in the form of extracts from the protocol.
  • The rules of work and conditions for storing documentation should ensure that the confidentiality of the Commission’s work is respected.
  • Meetings of the Commission are held depending on the actual volume of ethical expertise and are considered competent if at least half of the members of the Commission are present.
  • The decisions of the Commission are made by a simple majority of the votes of the members by open voting in the presence of a quorum and are drawn up in minutes.
  • The minutes of the meetings of the Local Ethics Commission are signed by the Chairman and the Executive Secretary.
  • The Commission maintains and stores the necessary documentation (standard procedures, lists of Commission members, minutes of meetings, clinical trial materials, reports, etc.) in accordance with SOP 011 Documentation and archiving.