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DEU logo DOKUZ EYLUL UNIVERSITY
IZMIR INTERNATIONAL BIOMEDICINE AND GENOME INSTITUTE
DIRECTIVES OF THE LOCAL ETHIC COMITTEE FOR ANIMAL EXPERIMENTS (IBG-AELEC)
iBG Logo
 

OBJEVTIVES
Article 1.

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.

EXTENT
Article 2.

(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:

  1. Non-experimental agricultural applications,
  2. Non-experimental clinical veterinary applications,
  3. Clinical experiments that are done for marketing competency to commercial veterinary health products,
  4. Applications that are done by registered or certified livestock enterprises,
  5. Applications whose primary purpose is identification of an animal.

BASIS
Article  3.

This protocol is established with regards to the;

DESCRIPTIONS
Article 4.

As it is in this directive;

  1. Ministry: TR Ministry of Forest and Water Affairs,
  2. CITES Agreement: Convention on International Trade in Endangered Species of Wild Fauna and Flora as published in the Official Gazette no. 22672 on 20/6/1996,
  3. Work Permit: DThe permit given by the Ministry of Food, Agriculture and Livestock to institutions that use, produce and supply laboratory animals,
  4. Experiment: Any type of procedure that is applied to laboratory animals for scientific reasons,
  5. Laboratory Animal: Free-living or producing larvae forms, live cephalopods and any type of vertebrates except for human being including mammals after the last one thirds of their embryonic development stage,
  6. Experiment Unit: Units where all types of procedures regarding animal experimentation is done, with the authorization from the Ministry of Food, Agriculture and Livestock,
  7. Ethics: The universal system of moral principles that regulate the borders of applications that can be done at the units where animals are used in scientific experiments that affect human and animal lives,
  8. General Manager: Head of Directorate General for Nature Conservation and National Parks,
  9. General Directorate: General Directorate for Nature Conservation and National Parks,
  10. CECAE: Central Ethical Committee for Animal Experiments,
  11. IBG-AELEC: Izmir International Biomedicine and Genome Institute Local Ethical Committee for Animal Experiments,
  12. Animal Welfare Unit: A unit that must be founded within institutions that are authorized to handle, produce, supply, and research on animals, composed of at least one responsible veterinary doctor, a veterinary health technician or a veterinary health technical. At the user institutions the unit must be formed of maximum three people one of which is a personnel from above group and one of them should be local ethical committee member,
  13. Humane Euthanasia Method: To terminate the life of an animal without causing too much stress, physical or sensorial pain peculiar to its species,
  14. In-vivo Experiment: Experiment that is done on living things,
  15. Good Laboratory Practice: The quality management system of both the planning, executing, recording, reporting and storing health and environment safety works in addition to the clinical research and the management methods,
  16. User: A person who is authorized to utilize animals in the procedures,
  17. Institution: Any type of portable or fixed building and their additions that have the work permission by the Ministry of Food, Agriculture and Livestock,
  18. Project: A work program that has a specific scientific purpose and contains one or more procedures,
  19. Procedure: Using animals for known or undefined experimental and educational reasons, giving pain to the animal as much as or more than an injection, torture, suffering or permanent damage pertaining to good veterinary applications and processes including procedures such as delivering a baby animal, breeding and sustaining of genetically modified animals,
  20. Secretary: The person or persons who makes the necessary coordination, correspondence and keeps records in the Ethical Committee,
  21. Senior Technician: A person who graduated from associate veterinary study programs after high school education,
  22. Technician: A person who graduated from one of following: Agricultural Technical School of the Ministry of Education Veterinary Department; Veterinary Health Technical School, Animal Health Officer School or Animal Health Officer Technical School which once were founded under Ministry of Food, Agriculture and Livestock,
  23. Animal Health Official: A person graduated from any vocational School,
  24. DEU: Dokuz Eylul University,
  25. Species: The biological group of organisms that have common characteristics and in which two individuals can produce fertile offspring,
  26. 3R Principle: The Principle that was formed by W.M.S. Russell and R.L. Burch in 1959:
    • Replacement (Replacement); methods which avoid or replace the use of animals in research,
    • Reduction (Reduction); use of methods that enable researchers to obtain comparable levels of information from fewer animals, or to obtain more information from the same number of animals,
    • Refinement (Refinement); use of methods that alleviate or minimize potential pain, suffering or distress, and enhance animal welfare for the animals used.
  27. Authorized Person: the person that is responsible for the laboratory animal unit within Dokuz Eylul University where the animal breeding, housing and procedures are performed.

FORMATION OF THE LOCAL ETHICS COMMITTEE FOR ANIMAL EXPERIMENTS (IBG-AELEC), QUALIFICATIONS AND ASSİGNMENT OF THE MEMBERS

Article 5.

(1) FORMATION OF THE LOCAL ETHICS COMMITTEE FOR ANIMAL EXPERIMENTS (IBG-AELEC), QUALIFICATIONS AND ASSİGNMENT OF THE MEMBERS

The IBG-AELEC is composed of:

  1. A full time veterinarian with Certificate in Laboratory Animal Science, who is responsible of breeding, producing and the daily care of laboratory animals with at least one year of experience on animal experiments,
  2. One representative from each unit in which laboratory animals are currently being utilized,
  3. A civil member, a Turkish Citizen, with no mutual interest with the institute and who has no connection to any experiments on laboratory animals, neither do his/her close relatives,
  4. A Turkish citizen member who is member of a non-governmental organization,
  5. At least one member of the committee has to have at least one year of experience in in vivo animal experiments, and holding a Ph.D. or specialty in medicine. Ethical experts in medicine or veterinary medicine are preferred in IBG-AELEC. The composition of IBG-AELEC can be decided by the institution due to their needs and administrative structure. IBG-AELEC may consult and invite experts from different fields whenever needed.

(2) ASSIGNMENT TO IBG-AELEC and TERM OF OFFICE

  1. The Ethical Committee is composed of mininum 5 maximum 18 members. The rector of DEU assigns the chair, vice-chair and the members of the ethical committee for 4 years. The member whose term of office expires may be appointed by the rector again.
  2. Membership of a member is terminated when he/she skips the meetings three times in a row without any excuse. The chair of the committee and the veterinary must be working full time.
  3. The secretary of ethical committee is assigned by the rector of DEU and he/she is responsible of accepting applications, regulating AELEC’s work and of archiving the resolutions.

IBG-AELEC WORKING METHOD
Article 6.

  1. IBG-AELEC meets twice a month with participation of at least two-thirds of the members with the agenda specified by the chair.
  2. The decisions in IBG-AELEC meetings are made according to the majority of votes. In case of equality of votes, it is decided due to the casting vote.
  3. All records regarding laboratory animals within IBG-AELEC are kept by the authorized veterinarian in the animal welfare unit who is responsible for laboratory animal breeding and care and IBG-AELEC controls this processes.. These records should contain the information regarding the number and species of the animals, where they were obtained, when they were transferred to the institution they are used by and all procedures performed on animals. These records are kept at least 5 years.
  4. In order to evaluate the applications, IBG-AELEC prepares an application form that should contain the following information:
    1. The title of the project.
    2. The name, surname, title, institution, division, telephone, e-mail, task in the project and the signature of the project coordinator and of the other researchers involved.
    3. The place and duration of the procedures.
    4. Training certificates of the participants who will perform the animal procedures.
    5. The date of the application.
    6. The project proposal.
    7. The abstract of the project written in a simplified, daily language.
    8. The source of the animals, the approximate animal number, the age and species of the animals.
    9. Description of the procedures that will be performed on the animals.
    10. Description of the pain, agony and permanent injury caused by the procedures.
    11. Description of how the 3R principles (Replacement, Reduction, Refinement,) are applied to the procedures.
    12. The anesthesia, analgesia and other pain relieving methods to be used in the procedures.
    13. Description of measures that will prevent lifelong agony or reduce the pain.
    14. Determination of the humane euthanasia methods at the end of the procedures.
    15. Description of the experimental or observational strategies and data analysis techniques to reduce the number of animals, the agony, pain and suffering caused by the procedures, and the eventual environmental effects.
    16. To state whether animals are going to be used for more than one project.
    17. The housing, breeding and care conditions of the animals.
    18. The competence of the participants in the project.
    19. The commitment letter.
  5. IBG-AELEC gives permission for a project for maximum 5 years. When a time extension is required, extra time may be granted as long as the reason is justified.
  6. All applications and decisions are recorded with date and registry number. Records are kept for at least 5 years.
  7. Applications are done by the project coordinator. For dissertations, the project coordinator is the academic advisor.
  8. IBG-AELEC assesses the applications as:
    • Approved,
    • Demands revision,
    • Conditional approval,
    • Not approved.

    The written decisions are pronounced to the applicants in maximum 40 work days. Evaluation is included in this period. If the project is too complex or multidisciplinary, and requires experts from different fields, IBG-AELEC may extend the time only for once for maximum 15 working days. The applicant is informed about this extension beforehand with the reason and amount of time needed. IBG-AELEC may demand preliminary experiments to be performed with a small number of animals in order to test the feasibility of the project. In this case, the final approval is given according to the principles applied for conditional approvals.

  9. While assessing the project of a member of the IBG-AELEC, the applicant can neither attend nor vote in the meeting.
  10. Projects assessed as “Demands Revision” are re-evaluated after being revised. Projects assessed with “Conditional approval” are observed by the animal welfare unit for a while specified by IBG-AELEC, and after being evaluated and reported back whether it meets the necessary conditions or not, go under evaluation again by IBG-AELEC as either “Approved” or “Not Approved”.The working principles and methods of the animal welfare units are regulated according to the regulation of the “Ministry of Food, Agriculture And Livestock”, 28141.
  11. IBG-AELEC inspects the granted projects for any changes that would adversely affect animal welfare.If the approved project does not comply with, IBG-AELECwill cancel the given ETHIC approval. When an approval is cancelled, the animal welfare unit rearranges the conditions of the animals to ensure that the animals used or intended to be used are not negatively affected.
  12. After the project is approved by IBG-AELEC, any changes in the project or any changes in the participants needs to be reported to IBG-AELEC in written form by the project manager after being approved by all the members of the project.
  13. The following interventions are not subject to the approval of the ethics committee:
    1. Clinical applications for diagnosis and treatment,
    2. Procedures performed on dead animals or their tissues, slaughterhouse materials and waste fetuses,
    3. Milking an animal,
    4. Collection of feces or bedding samples,
    5. Sampling by swab.
  14. The permission from the General Directorate about the use of wild animals from nature to identify a species replaces the permission of IBG-AELEC.
  15. In case the field research is conducted in more than one city, it’s sufficient to get approval from the ethical committee of one of these cities.
  16. All records of IBG-AELEC are kept open to the control of the Center for Animal Experiments (CECAE) and Ministry.
  17. IBG-AELEC may obtain the written opinions of experienced experts if necessary or invite them to the IBG-AELECmeeting for oral or written opinion.

DUTIES of IBG’s HADYEK
Article  7.

  1. To prepare protocols about the work plan and essentials of IBG-AELEC in accordance with the ethical principles and good laboratory practices determined by CECAE and the Directive on Animal Ethics Committee Work plan and Essentials.
  2. To approve or refuse the protocols for the procedures to be performed on the laboratory animals by determining the ethical acceptable limits of all the procedures to be carried out.
  3. To supervise the use of laboratory animals in the institution in accordance with the 3R principles and ethical rules and to make necessary arrangements for this purpose.
  4. To contribute to the development and verification of alternative methods which may provide the same or higher level information as those obtained using the laboratory animal, but which involve procedures in which no or less animals or less painful procedures are used, and to encourage research in this area.
  5. To ensure that the procedures on the animals are carried out in accordance with the approved protocol, and to decide on a termination if necessary.
  6. To ensure that the required training is received by the personnel working with laboratory animals and approve animal experiments only if a Certificate in Laboratory Animal Science is provided. To organize certificate programs for this purpose when necessary.
  7. To check the production, breeding, housing and transportation conditions of the laboratory animals and the laboratory conditions and equipment of the experiments are ethically appropriate.
  8. To submit statistical data sheets and annual activity report to the CECAE regarding the use of the laboratory animals.
  9. To ensure the disposal of wastes and medical wastes resulting from animal experiments within the framework of the Environment Law dated 9/8/1983 and numbered 2872 and relevant legislation.
  10. To ensure that laboratory animals are recorded and monitored within the framework of the provisions of the Law on the Protection of Animals (No. 5199) and related legislation.
  11. To notify CECAE 30 days before the certificate courses are held.
  12. To inform CECAE about the certificate programs they have organized and the information about the trainees who have successfully passed the training.
  13. To decide whether it is proper or not to own or send the animals back to farms after they undergo the procedures.

AUTHORISATION AND OPERATION PRINCIPLES of IBG-AELEC
Article 8.

IBG-AELEC works in line with the following principles;

  1. To prevent ill-treatment of laboratory animals that are required to be used in scientific research and education.
  2. To ensure that the animals are used within the scope of the purposes set out in article 5 of the Directive on Animal Ethics Committee Work plan and Essentials.
  3. To ensure that animals are not used in experiments with severe pain, stress, or equivalent suffering, but if they must be used, it should be based on sound scientific grounds.
  4. To publicise prevention of animals in painfull experiments at educational congresses, conferences and seminars.
  5. To ensure that scientifically reliable data is obtained by inflicting as little pain on animals as possible and by introducing them to the least stress.
  6. To prepare appropriate conditions for the laboratory animals during research and provide them with the best physiological, behavioral and environmental conditions.
  7. To provide the animal care under appropriate conditions by suitably trained personnel.
  8. To ensure that laboratory experiments to be carried out on live animals are conducted under the supervision of a veterinarian in charge.
  9. To ensure that researchers define humane endpoints of the conditions when the experiments need to be terminated.
  10. To disapprove the animal experiments if there are alternative methods of obtaining the information searched that have proven valid, and to prevent the repetition of previous detailed experiments.
  11. To ensure that the most appropriate animal species and method for the scientific experimentation is selected, with minimum number of animals to obtain meaningful experimental results.
  12. To ensure that an appropriate anesthesia procedure is applied to animals in experiments that give unnecessary pain and suffering and that appropriate pain reliever and anesthesia is used in research.
  13. To prevent the use of anesthesia if it gives more trauma to the animal than the experiment itself, and if it does not fit the purpose of the experiment.
  14. To comply with ethical principles and experimental purposes, the following measures can be taken by the veterinarian;
    1. To ensure giving painkillers to the animal subjected to great deal of suffering after anesthesia, and if it is not possible to cure, euthanize it with a humane method,
    2. To ensure the euthanasia procedures be done with satisfactory justifications during or at the end of the experiments,
    3. To ensure to put the animals down that are under severe and persistent pain or suffering that can not maintain a normal life and pose a risk to both their health and others’ with a humane method.
  15. To provide healthy living conditions for the test animals used in the experiments that will continue to live afterwards.
  16. To decide whether the experiments that expose animals to intense and long-lasting pain are done or not considering the ethical principles, the benefits to be gained from the research and the agony of animals.
  17. To reduce the number of animals used in experiments by letting them be used more than once in the experiments as long as the animal’s well-being does not deteriorate and it does not deviate the experiment from its scientific purposes.
  18. To ensure that the tissues and organs of the dead animals used in the experiments are utilized in other applications.
  19. Avoid practices that may result in potential severe pain, suffering, and agony which is nonrecoverable.
  20. To approve procedures to be carried out only under the supervision the animal welfare unit of IBG-AELEC.
  21. To follow the changes to be made in the approved projects, the content and the persons to participate in the work and ensure that the necessary permissions are obtained.

PRACTICES RELATED TO ANIMAL EXPERIMENTS AND RESEARCH LABORATORY ANIMALS
Article 9.

(1) Issues regarding the animals used in the researh applied to IBG-AELEC:

  1. The complete experimental procedure that will be performed must be approved by the IBG-AELEC.
  2. The following animals can be used for experiments in accordance with the regulations made by the DEU-HADYEK, unless a general or special exemption has been taken;
    1. Mouse (Mus musculus),
    2. Rat (Rattus norvegicus),
    3. Guinea pig (Cavia pocellus),
    4. Syrian (golden) hamster (Mesocricetus auratus),
    5. Chinese hamster (Cricetulus griseus),
    6. Mongolian gerbil (Meriones unguiculatus),
    7. Rabbit (Oryctolagus cuniculus),
    8. Dog (Canis familiaris),
    9. Cat (Felis catus),
    10. All species of non-human primates
    11. Frog [Xenopus (laevis, tropicalis), Rana (temporaria, pipiens)],
    12. Zebrafish (Danio rerio).

    All species and animals used in experiments and legal tests must be registered and provided from a breeder and/or a supplier.

  3. Stray animals such as cats and dogs living in the streets can not be used in experiments. However, However, these animals can be used in experiments when there is a need to study the health and well-being of these animals, there is a serious danger to the environment, human and animal health and there is enough scientific justification showing that studies can be only achieved by using stray-animals in the experiments.
  4. Non-human primates can only be used in experiments, in exceptional cases and with the explicit scientific justification showing that the purpose of the procedure cannot be achieved by using any animal other than a non-human primate.
  5. Big hominoidea cannot be used in any type of experiments.
  6. Within the framework of national legislation and international conventions, endangered and protected species and the species listed in the Appendix 1 of CITES Convention are permitted to be used in the following cases:
    1. If the procedure has one of the purposes specified in subclause (1) of clause (b) of the first paragraph of Article 5, and clauses (c) and (d).
    2. If there is a scientific justification showing that the purpose of the procedure can not be achieved with species other than the relevant species.
  7. A scientific experiment on wild animals taken from their natural environment can be approved only if the alternative species are not sufficient for the purpose of the experiment. After the approval of IBG-AELEC, a permission is taken from the General Directorate.

SEVERITY CLASSIFICATION OF THE EXPERIMENTS, ANESTHESIA AND IMPLEMENTATION OF ANESTHESIA, ACT OF KILLING AND OTHER RELATED HANDLINGS DURING
Article 10.

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
Article 11.

(1) Reuse of an animal previously used in one or more experiments is allowed in the following situations:

  1. If the actual severity of the previous experiments is “mild” or “moderate”.
  2. If the animal’s general health status has completely recovered.
  3. If the new experiment is classified as “mild”, “moderate” or ” non-recoverable”.
  4. If it has been deemed appropriate by a veterinarian who will be able to evaluate previously performed procedures on the animal.

(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
Article 12.

(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.

PROJECT APPLICATIONS
Article 13.

Projects to be accepted to IBG-AELEC:

  1. All laboratory animal research projects that are carried out by DEU academic staff, especially iBG staff,
  2. Projects and studies that include learning a method / model and manual handling practice,
  3. Multicenter research projects that iBG participates as a partner center,
  4. Research projects that are carried out by researcers from other agencies and organizations that apply DEU Experimental Animal Laboratory for experimental studies.

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
Article 14.

In the application to the Committee, personal declaration is essential and the applicants sign a commitment form.

  1. They accept the accuracy of the information they provide on their application forms.
  2. They undertake not to start the experiments without the approval of IBG-AELEC.
  3. They accept to carry out the procedures on the test animals in accordance with the issues specified in the application form and they agree to open their working order to the members of IBG-AELEC incase IBG-AELEC wants to observe their work. Any changes to the research project after the approval of İBG-HADYEK should be notified to İBG-HADYEK in a written form and an approval should be obtained again.
  4. Applications must be made at least 5 (five) business days prior to the announced meeting date in order for the applications to be considered for the first scheduled meeting.
  5. It is compulsory for people out of Dokuz Eylul University to attach the permission document obtained from the unit where the studies are carried out to their ethical committee application.
  6. Applications for the thesis studies must be made by the “Academic Advisor” as “Coordinator ” and applications for other projects must be made by an academic staff with a doctorate or equivalent degree as “Coordinator of the Project”. It is compulsory to attach permit documents from animal owners for the applications on field or clinical trials.

PROPERTIES AND PROJECT FORMAT IN PROJECT APPLICATION
Article 15.

(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:

  • A letter of Application,
  • 3 copies of IBG-AELEC Ethics Committee Application Form (1 original and 2 copy),
  • 3 copies of Certificate in Laboratory Animal Science (of the researcher who is to do the animal manipulations),
  • 3 copies of IBG-AELEC declaration letter (1 original and 2 copy) (Annex 2),
  • One CD including the electronic application form of IBG-AELEC,
  • Three copies of basic literature the project is based on (supporting hypotheses, tools and methods of the project),
  • If company support is to be provided on the research budget, a conflict of interest document should be added (Annex 3).
  • During the APPLICATION to IBG-AELEC;
    1. Related forms / documents (see Annex 1, Annex 2 and Annex 3) can be found in the “Academics” / “Ethics Committees” section on the web page of Dokuz Eylul University
    2. Forms / documents will be submitted to IBG-AELEC Secretariat. These documents are:
    3. Letter of Application (Annex-1)
    4. Declaration Letter (1 Original, 2 copy)
    5. Three Project Application Forms (1 Original, 2 copy)
    6. Conflict of Interest Document (Annex-3)
    7. Three literature supporting the research
    8. CD in which the Project Application Form and the supporting documents are saved
    9. Certificate in Laboratory Animal Science (of the researcher who is to do the animal manipulationS- 3 copy)

EVALUATION OF PROJECTS AND DECISION MAKING
Article 16.

(1) Projects are evaluated according to following criteria:

  1. The scientific, educational or legal justifications,
  2. The reasons for animal use,
  3. Realization of the procedures in a maximum humane and environmentally sensitive way,
  4. The predicted scientific benefits and the value for education,
  5. Compatibility to the 3R principle,
  6. Severity classification of experiments,
  7. The benefits to be gained and the suffering of animals,
  8. The compliance of killing method, procedures, anesthesia, re-use, care and housing conditions with the regulations,
  9. The decision to make a retrospective evaluation and timing

(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.

RETROSPECTIVE ASSESSMENT
Article 17.

(1) The following aspects can be evaluated retrospectively in the documents reported to IBG-AELEC:

  1. Whether the goals of the project have been achieved or not.
  2. The number of animal species used, the harm given and the severity classification.
  3. Elements that can contribute to the implementation of the 3R principle.

(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
Article 18.

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:

  1. To have taken minimum 80-hour-training that includes theoretical and practical courses,
  2. To prove that they have participated in at least 80% of the mandatory training,
  3. To certify that they have succeeded (> 70/100) in the examination at the end of the training.

LAST TERMS
PRIVACY
Article 19.

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.

ENFORCEMENT
Article 20.

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.

EXECUTION
Article 21.

The terms of this directory are executed by the Rector of DEU.

 


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