Bioethics Committee
Regulation of the Bioethics Committee

Regulation of the Bioethics Committee



1.1. The KSMA Bioethics Committee (hereinafter referred to as the KSMA BC) is an expert and analytical organization independent of the researcher and the customer, designed to provide independent expertise, advice, monitoring and decision-making on the ethical evaluation of biomedical research involving humans and/or animals in order to protect the dignity, interests, and health rights of participants in the research, educational and therapeutic process. The work comes from KSMA.


1.2. The KSMA BC relies in its assessments, recommendations and decisions on the basic principles:

  • regulatory documents regulating the conduct of biomedical research involving humans and animals, as well as the current legislation of the Kyrgyz Republic.

1.3. The KSMA BC takes into account national and international guidelines on the ethics of biomedical research with human participation, UNESCO, SIOMS, WHO, the Council of Europe Convention on Human Rights and Biomedicine, and other instruments in its work when evaluating, recommending, and making decisions.

1.4. The KSMA BC develops its own Standard operating procedures (SOPs) based on Recommendations to Ethics Committees conducting Biomedical Research Expertise (Geneva, WHO, 2000 and FECCIS/ SIDCER/WHO/2004, SP, 2004).

1.5. The KSMA BC fulfills the international and national requirements of the Kyrgyz Republic for compliance with insurance guarantees for research participants.

1.6. The KSMA BC is established and operates in accordance with national legislation and strives to comply with international requirements for compliance with guarantees for participants in biomedical research, and monitors scientific research.

1.7. In its activities, the KSMA BC recognizes and respects the diversity of cultures and religions, and adheres to the principles of independence, openness, competence and pluralism.

1.8. The decision of the KSMA BC can be formulated in such a form as "approved", "approved with recommendations at intermediate stages", "not approved".

1.9.In the course of its activities, the KSMA BC has the right to make changes or additions to this Provision.

  1. Ethical principles during the examination

2.1. Protection of the dignity of people involved in research, humane treatment of animals used in scientific experiments.

2.2. Usefulness of the research results for the persons involved in the research and usefulness for the society as a whole.

2.3. Equity in the distribution of benefits and risks when conducting scientific research involving humans and animals, taking into account the interests of the subjects, the local community and the customer.

3.KSMA BC structure

3.1. The founder of the KSMA BC is the KSMA Academic Council.

3.2. The KSMA BC may include from 7 to 15 people, who should not be directly dependent on the researchers and the customer.

3.3. Members of the KSMA BC should represent various fields of expertise in order to ensure a complete and adequate ethical review of research.

3.4. Members of the KSMA BC may be persons who have the appropriate qualifications and experience in the expert evaluation of scientific, medical and ethical aspects of various studies and are distinguished by responsibility and integrity, should not have a personal interest in the planned research.

3.5. The number of members of the ethics committee should include specialists in the field of medicine, biomedical problems, a specialist in the field of law, at least one specialist whose main field of activity is not the field of medical science.

3.6. Members of the KSMA BC should be of different gender and age, the scope of professional activity is not limited.

3.7. The Chairman of the committee is appointed by the order of the Rector of KSMA, proposals for the composition are initiated by the chairman and members of the BC, and approved by the order of the Rector of KSMA. The Chairman is appointed for a term of five years.

3.8. The expansion of the membership and the introduction of new members is carried out by the decision of the bioethical committee. New members are introduced into the BC after a unanimous vote of the members of the Academic Council and the approval of their candidacies by the order of the Rector of KSMA.

3.9. Members of the bioethical committee are selected on the basis of their personal qualities, interests, knowledge and experience in the field of ethics or science. Members of the Bioethical Committee are appointed for a term of five years and their term of office may be extended by decision of the KSMA Science Council, but not for more than two consecutive terms.

3.10. The KSMA BC may base its decisions on individual Research Protocols or recommendations on the opinion of independent consultants (experts) on certain issues without the right to vote. An independent consultant for the examination of a specific study is appointed by the chairman of the BC from among specialists in highly specialized disciplines. Independent consultants, when involved in an ethical review, as well as members of the BC, must sign a confidentiality agreement on a conflict of interest.

3.11. The structure of the KSMA BC also includes a Vice-chairman, who is responsible for holding meetings in the absence of the chairman and for assisting him in holding meetings.

3.12. The Secretary of the KSMA BC is responsible for the administrative aspect of the committee's activities, for receiving documents, keeping minutes of meetings and making extracts from the minutes.

  1. Subject of ethical review


4.1. Dissertation author's works at the stages of:

- topic approval procedures;

- conducting research (monitoring);

4.2. Research programs commissioned by third-party organizations, carried out by a group of researchers:

- at the design stage;

- implementation of the research results in practice.

4.3. Scientific articles, monographs published in international and national publications and journals.

4.4. Advertising information of medical, pharmaceutical and biomedical products based on biomedical and pharmaceutical research activities that have passed the ethical expertise of the KSMA BC.


  1. The main activities of the KSMA BC


  5.1. The main activities of the KSMA BC are:

  • expertise of research projects and studies involving both sick and healthy people, animals in accordance with the norms of the current legislation of the Kyrgyz Republic, international ethical standards;
  • determining the ethical criteria of recipients (addressees) of medical care in terms of eliminating social inequality, implementing the principle of social justice and protecting the rights of the individual and the usefulness of the results;
  • study and application of international experience of legal and ethical regulation in biomedical research;
  • organization of complex interdisciplinary scientific research on bioethical problems and development of practical recommendations based on them;organization and implementation of scientific, theoretical and practical events on bioethical issues;
  • participation in the ethical and legal education of medical professionals and citizens in the field of human rights protection during biomedical research;
  • participation in expert evaluation of advertising of medical and pharmaceutical activities, as well as goods and services that violate the rights of citizens to health protection;
  • All materials approved by the KSMA BC are marked "Approved by the KSMA BC" with the date and number of the protocol.


  1. Working procedure of the KSMA BC


6.1. The structure and activities of the KSMA BC, evaluation, decision-making and control over their implementation, are carried out on the basis of this Regulation and the developed SOPs, reviewed and approved by the PBC.

6.2. The KSMA BC is accountable to the KSMA Academic Council and reports to it once every two years.

6.3. Meetings of the KSMA BC are held as soon as the materials are received.

6.4. The Executive Secretary notifies about the date and time of the meeting, its agenda no later than 1 week before the meeting.

6.5. Members of the KSMA BC should personally study and analyze the documents planned for consideration before the meeting.

6.6. A meeting of the KSMA BC may be held and its decisions are considered valid if 50% + 1 of the committee members are present at the meeting.

6.7. The KSMA BC is obliged to ensure the timely issuance of a written opinion on the decision taken at the meeting of the Committee (within 10 working days after the meeting).

6.8. The KSMA BC maintains the necessary documentation in accordance with international and developed standard operating procedures.


  1. Rights, duties and responsibilities of KSMA BC members


  Members of the KSMA BC have the following rights:

   7.1 Review the documents submitted to the committee:

  • international conventions signed by the JK of the Kyrgyz Republic;
  • national legal and other documents;
  • interdepartmental bodies;
  • by the orders of the KSMA.

    7.2. Get acquainted with the materials submitted to the KSMA BC for bioethical examination (dissertations, research projects of KSMA, programs for conducting scientific research, scientific articles

    7.3. Evaluate the received documents and the situations under consideration.

    7.4. Argue for recommendations.


        Members of the KSMA BC are required to:

7.5. Each member of the KSMA BC must sign a confidentiality agreement that ensures that information that is not subject to disclosure is kept secret from unauthorized persons.

7.6.The members of the Committee should indicate any conflict of interest or any degree of interest - financial, professional or otherwise-in any project or proposal to be considered, and the BC should determine the possibility and conditions for the participation of BC members who have any conflict of interest in the discussion and formation of BC recommendations.

        Members of the KSMA BC are responsible for:


7.7. violation of the Provisions of the KSMA BC.

7.8. disclosure of the procedural details of the work of the KSMA BC.

7.9. lobbying and receiving personal remuneration for performing the duties of a member of the KSMA BC from third parties and organizations.