100-2000 YÖK Doktora Bursu 2019-2020 Bahar Yarıyılı İlanı
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|DOKUZ EYLUL UNIVERSITY
IZMIR INTERNATIONAL BIOMEDICINE AND GENOME INSTITUTE
DIRECTIVES OF THE LOCAL ETHIC COMITTEE FOR ANIMAL EXPERIMENTS (IBG-AELEC)
The aim of this protocol is to determine the acceptable minimal ethical standards, to deliver opinion, demarcate the borders for applications, to assess the applications from this point of view for keeping, raising, making observations on them, producing, using for experiments, isolating from nature and transporting of all animals that are used for experiments, experimental research, training, testing and health service applications at DEU, iBG or other institutions. By forming a Laboratory Animals Local Ethics Committee (HAYDEK) it aims to give judgment about ethics principles; and to inspect, approve and (where necessary) to terminate research proposals, including the essential procedures, and the presentation of planned studies.
(1) The protocol contains, all required permissions to be taken before the application to DEU, iBG and other institutions where animals are used for experimental purposes, establishment of Dokuz Eylul University Local Animal Ethics Committee for this reason, The procedures and principles of the work, the tasks of the establishment and the training, supervision and obligations.
(2) (1) This protocol does not contain:
This protocol is established with regards to the;
As it is in this directive;
FORMATION OF THE LOCAL ETHICS COMMITTEE FOR ANIMAL EXPERIMENTS (IBG-AELEC), QUALIFICATIONS AND ASSİGNMENT OF THE MEMBERS
(1) FORMATION OF THE LOCAL ETHICS COMMITTEE FOR ANIMAL EXPERIMENTS (IBG-AELEC), QUALIFICATIONS AND ASSİGNMENT OF THE MEMBERS
The IBG-AELEC is composed of:
(2) ASSIGNMENT TO IBG-AELEC and TERM OF OFFICE
IBG-AELEC WORKING METHOD
DUTIES of IBG’s HADYEK
AUTHORISATION AND OPERATION PRINCIPLES of IBG-AELEC
IBG-AELEC works in line with the following principles;
PRACTICES RELATED TO ANIMAL EXPERIMENTS AND RESEARCH LABORATORY ANIMALS
(1) Issues regarding the animals used in the researh applied to IBG-AELEC:
SEVERITY CLASSIFICATION OF THE EXPERIMENTS, ANESTHESIA AND IMPLEMENTATION OF ANESTHESIA, ACT OF KILLING AND OTHER RELATED HANDLINGS DURING
The procedures related to anesthesia and its implementation, killing and severity classification of experiments are carried out in accordance with the articles 21 and 22, and Annex-8 and Annex-9 of the Directive on Protection And Welfare Of Laboratory Animals Used For Experiments and Other Scientific Purposes published in the Official Gazette dated 13/12/2011 and numbered 28141 by Ministry of Food, Agriculture and Livestock.
RE-USE OF ANIMALS IN THE EXPERIMENTS
(1) Reuse of an animal previously used in one or more experiments is allowed in the following situations:
(2) In exceptional cases, after the examination of the animal by a veterinarian and by excluding subparagraph (a), an animal may be allowed to be re-used in an experiment involving severe pain, suffering or equivalent discomfort provided that the animal will not be used more than once.
TERMINATION OF EXPERIMENTS
(1) Every experiment is terminated when no more observations on the experiment can be performed, or when genetically modified animal breed or species are no longer be traced and If pain, suffering, and permanent damage equal to or more than the one needle penetration on an ongoing basis is expected, the experiments are terminated.
(2) At the end of an experiment, a veterinarian decides if an animal should survive. If an animal continues to survive, appropriate care and accommodation services are provided for its health condition. If the animal continues to live with moderate or severe pain, suffering, distress, and permanent damage, its life is terminated.
Projects to be accepted to IBG-AELEC:
The Applicantions to the Ethical Committee is done by filling out the Turkish or English version of the “Experimental Animal Ethics Committee Application Form” and submitting it to IBG-AELEC secretariat. The applications for thesis studies are made by the academic advisor as the coordinator of the project and in the other research projects, applications are done by project coordinators. The applications to be made from outside the university are done with the official letter of the project manager from his institution.
RESPONSIBILITIES OF THE APPLICANT
In the application to the Committee, personal declaration is essential and the applicants sign a commitment form.
PROPERTIES AND PROJECT FORMAT IN PROJECT APPLICATION
(1) The research project should describe the purpose, design, methodology, statistical aspects and organization of the work to be done.
The projects are edited in accordance with scientific criteria so as not to exceed 4-6 pages. The name of the research, type (experimental, preliminary study, thesis study, etc.) the name of the researchers, their place of employment, the contact address should be on the first page.
(2) Project Format
Filling out the application form:
Title page: The project name, the institutions of participating researchers, tasks and signatures, the research, and the contact details, department and etc.of the project coordinator.
Project Title: must be clear, short, and scientific that describes the whole project without abbreviations or jargons.
Project Summary: It should include goals of the project, the objectives, the materials/methods, the predicted damages and benefits, the species and the trait of the animals to be used in accordance with the 3R principles.
Introduction: The project’s rationale with relevant literature should be given in detail. Literature should be placed in the text according to the order of use.
Objective: The objective of the project reflecting the basic hypothesis should be written clearly and briefly.
Method: The research design, the experimental groups and the justifications for the study design, the drug doses, the route of administration, the place where the drugs are obtained, the literature on drugs if available, the amount of biological samples to be taken, the sampling and storage method, details on evaluation and test methods to be performed with literary support if available, selecting appropriate statistical method, surgical procedure to be performed on animals, brief information on postoperative care, methods of evaluation of laboratory findings, detailed technical information should be given on the place where the animals are to be kept, the conditions of the animals being kept and the permission certificate from the laboratory where testing is carried out, the method of termination of the experiment, time, cages and the companies where the necessary materials and equipment are obtained should be given in details.
Innovations that the project will bring: The innovations and contributions that the project will bring to the literature should be stated briefly.
References: Must be written in the order of use in the project and must be written according to the Index Medicus format at the end of the project.
Project coordinator should submit the application to IBG-AELEC by adding his or her letter (Annex 1).
The first application should include:
EVALUATION OF PROJECTS AND DECISION MAKING
(1) Projects are evaluated according to following criteria:
(2) The people to do the project evaluation for IBG-AELEC should be chosen regarding their competence in experimental design, animal experimentation or animal care and nutrition.
(3) The project evaluation must be transparant. The project evaluation is carried out in an impartial manner for the protection of intellectual property rights and confidential information.
(4) A member of IBG-AELEC is appointed as a reporter for each appropriate application. The reporter evaluates the project and explains his/her assessment to the Committee members at the meeting. The Board discusses the project. If the committee deems necessary, it can invite the researcher in charge to the meeting and ask questions and points that need explanation.
(5) After the project evaluation, IBG-AELEC makes its decision as ‘approved’, ‘demands revision’, ‘conditional approval’ and ‘not approved’. If one of the Ethics Committee Members participates in the project, he/she should not vote on that project. The applications that receive ‘demands revision’ is re-evaluated by the Ethics Committee after the applicant revises the project. The projects that receive ‘conditional approval’ will be monitored for a specific time that is determined by the decision of the Ethics Committee. Then the fulfillment of the required conditions will be re-evaluated and the decision will be finalized whether the project is ‘approved or ‘not approved. IBG-AELEC may evaluate whether the persons who will be practicing in laboratory animals are competent or not and if a person is believed not to have enough experience IBG-AELEC may offer the applicant to work with an experienced researcher in the field for a specific time to gain experience.
(6) The Ethics Committee approvals are given for 5 years and are valid for this period. Additional time may be requested for the projects that cannot be completed within this period.
(7) In the research protocol, it is mandatory to notify the ethics committee and obtain its approval to make changes after the initial Ethics Committee approval. No changes in a protocol can be made without the approval of the ethics committee. The study will be stopped if the protocol changes that are not approved by the ethics committee are implemented.
(8) All researchers working in the units of Dokuz Eylul University who will do research in the fields related to the activities described in Article 1 of “Dokuz Eylul University-Animal Experiments Local Ethics Committee Directive” are required to obtain the approval of IBG-AELEC with a written application.
(9) All national and international scientific publications related to the activities described in the Article 1 of IBG-AELEC Directive, are required to include the statement “Approved by the Ethics Committee” or “Complies with the Ethics Committee Principles”.
(10) The responsibility of the ethical issues originating from declaring “Approved by the Ethics Committee” or “Complies with the Ethics Committee Principles”, which appears in all national and international scientific publications of research related to the activities described in the Article 1 of IBG-AELEC Directive, without applying the Ethics Committee, belongs to the authors(s) of the publication.
(1) The following aspects can be evaluated retrospectively in the documents reported to IBG-AELEC:
(2) All projects where non-human primates are used, including procedures with long-lasting and untreatable severe pain, suffering, and agony,, torture and misery, are assessed retrospectively.
(3) Projects other than the provisions of paragraph 2 can be exempted from retrospective assessment.
TRAINING OF THE PERSONNEL DEALING WITH LABORATORY ANIMALS
In accordance with the Article 7/c of this directive, IBG-AELEC determines whether the persons who will deal with laboratory animals are qualified or not and then issues “Certificate in Laboratory Animal Science” to the persons who are trained according to the regulations executed by the Ministry of Forestry and Water Management. of Laboratory animal users can not perform experiments, training or to test procedures on these animals or keep these animals in their work places. In case the person who plans to use laboratory animals in the work submitted for approval has no certificate, the work is not approved. The persons who apply to get a “Certificate in Laboratory Animal Science” are required to fulfill the following conditions:
The correspondences of the ethics committee are confidential. No information is provided to third parties except for the authorized institutions described by the related legislation and the Directive of TR Ministry of Forestry and Water Affairs on Local Animal Ethics Committee Work Plan and Essentials.
This Directive is presented to the Central Ethical Committee for Animal Experiments after being approved by the Decision of the Senate of Dokuz Eylül University and shall enter into force on the date of its approval by the Central Ethical Committee for Animal Experiments.
The terms of this directory are executed by the Rector of DEU.
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