Erebouni Medical Center Prime Quality Standard

Ethic Committee

Chairman of EC - Narine Rafaelovna Mamikonian.

Contact information:

  1. Location:
  2. Hours: Monday from 14.00 to 15.00 (Specify the scheduling of appointments, please call: ......., Secretary of the EC -  AP Azizbekyan);
  3. Ethics Committee meeting held every last Monday of the month from 14.00 in the auditorium of EMTS.


The objectives of the Ethics Committee:

  1. Protection of the rights and interests involved in the study patients and healthy volunteers;
  2. Protection of the rights and interests of researchers;
  3. An impartial ethical assessment of clinical and experimental studies;
  4. Ensuring the quality of clinical and experimental studies, in accordance with international standards;
  5. Ensuring public confidence in that all ethical principles will be guaranteed and respected in any conducted clinical research.

 


The main tasks of the Ethics Committee:

  1. Independently and objectively evaluate the safety and security of human rights in relation to the subject, both in the planning stage and at the stage of the study performance;
  2. Assess conformity of research to humanistic and ethical standards;
  3. Evaluate the reasonability of each study;
  4. Assess the compliance of researchers, technical facilities, research protocols, election of the study subjects, the quality of randomization to the principles of the high-quality of clinical trials;
  5. Monitoring and control of implementation of quality standards in clinical trials to ensure the accuracy and completeness of the data obtained in clinical trials.


The Ethic Committee Members


 

Chairman of the Ethics Committee  – Nara Rafaelovna Mamikonian -Director EMC
Secretary of the Ethics Committee  – Arleta Azizbekyan – Chief Nurse of EMC
Members of the Ethics Committee  – Mikhail V. Manoukian - Medical Director EMC
  Arthur Albertovich Rostomyan - Executive Director EMC
  Konstantinov - Director of Information Agency "ARKA"
  AR Avanesyan - Director, Center for Health "Asclepius"
  His Eminence Tatev Sargsyan - Archbishop of St. Echmiatzin
  I. Kushkyan - a member of the volunteers group for relations with EMC visitors


Normative documents:


  1. Order for Ethic Committee creation
  2. List of Ethic Committee members
  3. Regulations on the Ethics Committee.


Standard procedures:

 

  1. The structure and regulation of the Ethic Committee
  2. Documentation of the Ethic Committee, reporting and archiving
  3. The procedure for decision-making.
  4. Ethical support, monitoring, follow-up and review of materials approved research.
  5. Requirements for Informed Consent and the procedure of its obtaining.
  6. Report on the implementation of multi-purpose clinical studies.


Documents for the conduct of clinical trials on the basis of EMTS;

  1. Protocol of Clinical Investigation (Format MS Word - 21 Kb)
  2. The title page (Format MS Word - 19 Kb)
  3. Requirements for the Provision of study materials in advance (Format MS Word - 31 Kb)
  4. Provision of the ethical review committee (the application) (Format MS Word - 40 Kb)
  5. Conclusion of a reviewer for scientific research (Format MS Word - 38 Kb)
  6. Forms of Informed Consent (Format MS Word - 30 Kb)


Documents for experimental studies on the basis of EMTS

  1. Documents of Ethic Committee needed forethic expertise conduction (Format MS Word - 29 Kb.)
  2. The title page (on paper folder) (format MS Word - 19 Kb.)
  3. A list of documents submitted to the EC to undergo ethic expertise (Format MS Word - 22 Kb.)
  4. Conclusion of the reviewer (Format MS Word - 37 Kb.)
  5. Procedure for the ethical expertise of research carried out on animals  (format MS Word - 38 Kb.)
  6. Information regarding the volume of performed research (Format MS Word - 22 Kb.)

 

In accordance with the "Law of Copyright and Related Rights" when copying or reproduction of materials posted on this site, specify the source - the Web site of the Erebouni Medical Center - erebunimed.com is highly requested.
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