The ethical committee at YSMU operates according to the administration No 12 decision from 10.11.2009. A main objective of Ethical committee (EC) is providing high level carried out to YSMU and other medical institutions of research works, their compliance to ethical standards. Activity of EC shouldn’t contradict local acts.
- Ethical examination of all medico biological researches.
- Development and publication of ethical standards and examination order.
- Protection of the rights of participants of research and educational and methodical work in YSMU and other medical institutions.
Basic principles of activity
Committee structure is formed by involvement of the competent persons capable to independent activity. The structure of EC should be various, the corresponding experts of different fields of knowledge should be included in its structure.
The candidate of the chairman affirms EC YSMU council, the chairman appoints members of council. Into structure of committee can enter from 11 to 17 members.
Acceptance the decision is defined by special order which is defined by EC Charter.
Those members who participate in demand discussion participate in vote. The same members, having speeded up which in examination of this demand can cause the conflict of interests, don’t participate neither in demand discussion, nor in vote. The decision is accepted on based a majority of votes.
Procedure of submission of the demand
The applicant represents in EC documents in armenian according to the requirements specified below. If the demand is made in compliance with EC requirements, it joins in the meeting agenda. If the demand doesn’t correspond to EC requirements, work to discussion isn’t accepted. Thus it is pointed to the applicant to causes of failure. After documentation reduction in compliance with EC requirements work is accepted to discussion at the next meeting of EC.
The agenda of the meeting is exposed on EC site in 7 days prior to the meeting. After the discussion at this meeting of EC future documents aren’t accepted any more. The decision of EC stands out to the applicant next day after meeting.
Meetings of EC are carried out according to the schedule. Members of the committee get acquainted in advance with the relevant documents. Advisers and heads can take part in demand discussion, if necessary express the opinion or send on e-mail in the conditions of confidentiality.
In the course of discussion it is paid attention to the following questions:
- research registration, compliance of the purposes and research problems standard of ethics
- justifications of a ratio of risk and advantage in research
- expediency of use of control group
- indications to a suspension or the research termination
- compliance of possibilities to the studied purposes and research problems
- discussion of structure of researchers
- principles of selection of the investigated
- providing medical care and protection of interests of participants of research
- financial and not financial compensation in case of damage drawing to participants of research.
The decision of the EC can be: 1) positive; 2) positive with remarks; 3) negative.
The answer is given in a written form. In case of negative or partially negative answer its detailed justification is given.
1. The statement addressed to the chairman of EC
2. Plan-annotation or other document subject to examination
3. An extract from the minutes of division (chair)
4. The brochure of the researcher where the contents of the demand, the research protocol with the indication of the schedule diagram of research, the operating procedure description with people or with laboratory animals are in detail described.
5. The short summary of used medicines, original techniques, their author’s updating (to discuss data on features and safety of examinees of drugs or technologies, and also data on results of clinical tests for the period of consideration of the demand, including the last scientific articles, other printing materials in the form of the short characteristic of examinees of drugs, etc.).
6. The signed office biography (CV) researcher and his research supervisor or the adviser with the indication of contact phones.
7. A form of the informed consent of the patient; if research with participation of children or persons with limited possibilities, information for parents /care givers is provided; an order of compensation of the damage received in the course of research; a consent to the anonymous publication of results of research in the open press.
8. The review issued by the reviewer of EC.
9. The previous decisions on this work (if those are available)
All materials should be written down on CD disk and are presented in EC in the folder for papers.