Ethics

Local Ethics Committee Directive

Ç.U. F.O.M.-EMRAP LOCAL ETHICS COMMITTEE DIRECTIVE

 

THE FIRST PART
Aim, Scope, Base and Definitions

Aim
ARTICLE 1 - The purpose of this directive is to determine the procedures and principles that are related with the duties, organization and administration of Çukurova University The Faculty of Medicine Experimental Medicine Research and Application Center Animal Experiment Local Ethics Committee.

Scope
ARTICLE 2 - This directive contains the produces and principles, education, supervision and responsibilities of Çukurova University The Faculty of Medicine Experimental Medicine Research and Application Center Animal Experiment Local Ethics Committee.

Base
ARTICLE 3 -This directive is prepared depending on 9th and 17th articles of Ministry of Environment and Forestry Animal Protection Law no.5199 which is published in official gazette on 24/06/2004.

Definitions
ARTICLE 4 – Aforementioned in this directive;
  1. University refers to Çukurova University
  2. Center refers to Çukurova University The Faculty of Medicine Experimental Medicine Research And Application Center,
  3. Chancellor refers to Chancellor of Çukurova University,
  4. Local Ethics Committee refers to Çukurova University Animal Experiments Local Ethics Committee (AELEC),
  5. Center Ethics Committee refers to committee consisting of agents of several institutions and establishments that are running within Ministry of Environment and Forestry and are providing the coordination between animal experiments local ethics committees,
  6. Experiment refers to using of animals that are grown in the way that causes pain, torture, disease or permanent damage, with the scientific and experimental purposes -including assisting at giving birth- , different from methods that are not experimental, stay out of agricultural or clinical veterinary implementations and are accepted as modern for killing or marking animals and the humanist methods that minimize the pain,
  7. Experiment animal refers to animal that is used or will be used in experiment,
  8. User of experiment animal refers to students, researchers, academic, medical, technical and administrative personnel that want to make any kind of research, education, implementation and test by using laboratory animal or support to program by touching, observing the experiment animals,
refers to.

THE SECOND PART
The Aim and Assignments of Local Ethics Committee

The Aim of Local Ethics Committee
ARTICLE 5 - The aim of Local Ethics Committee is to determine the essential procedure and principles that have to be obeyed in using animal or animal products of scientific researches that will be carried out with experiment animals in Çukurova University,

The Assignments of Local Ethics Committee
ARTICLE 6 –  Assignments of Local Ethics Committee are;
  1. determination and implementation of principles such as stop working, establishing rules in case of need, permitting, following, presenting an opinion, investigating the fact that whether ethic principles and rules are obeyed in the using of experiment animal, observational and scientific studies that are carried out with an experiment animal on the purpose of education,
  2. providing the essential education to the personnel that will work on experiment animal, organizing certificate programs for this purpose and hindering making animal experiments of anyone that has not experiment animal use certificate,
  3. controlling the fact that whether transportation, production, raising and accommodation condition of animal is appropriate with the laboratory where the experiment is carried out ethically or not and hindering the using of animal in the circumstances that local ethics committee sees as inappropriate,
  4. collecting all kinds of data about experiment animal using, preparing experiment animal using annual report and presenting it to Center Ethics Committee,
  5. providing the elimination of wastes that cause from experiment studies, medical wastes and dead animals within the scope of Environment Law no.2872 and applicable law,
  6. providing the recording and tracking of experiment animals within the scope of terms that come with applicable law and Animal Protection Law no.5199,
THE THIRD PART
Formation, Tenure and Operation Mode of Local Ethics Committee

The Formation of Local Ethics Committee
ARTICLE 7 - Local Ethics Committee consist of nine members and they are;
  1. Director of Ç.U. F.O.M.-EMRAP
  2. a veterinary surgeon that is experienced for at least a year and responsible for raising, production and caring of experiment animal in institution,
  3. overall four lecturer that has one-year experience of animal experiment in university units that work on experiment animals,
  4. one lecturer from The Faculty of Medicine The Departments of Deontology and History of Medicine,
  5. a member that is out of university and does not work on experiment animals
  6. and a member of non-governmental organizations that have not anything with the university.
The Tenure of Local Ethics Committee
ARTICLE 8 - Members of Local Ethics Committee are assigned for four years by Rector. Expired member can be reappointed. Rector assigns one of the members as director. The most senior lecturer acts for director in the circumstances that the director is absent. The membership of any member that is absent for three consecutive meeting with or without excuse gives up by itself. In situations such as ending of membership due to death, retirement or leaving or giving up membership, a new member is selected with same procedure in order to fill the tenure of left member. Local ethics committee can determine the local ethics committee according its own needs and administrative features. Local Ethics Committee can receive opinions from experts or can invited to meeting in case of need.

Operation Mode of Local Ethics Committee
ARTICLE 9 - Local Ethics committee is operated as noted below:
  1. Local Ethics Committee is gathered monthly with absolute majority and agenda that is determined by the chairman of committee Ç.U. F.O.M.-EMRAP. Chairman can call the members to hold an extraordinary meeting if s/he considers it necessary.
  2. Local Ethics Committee meetings are carried out by deputy chairman in the absence of chairman. Decisions are taken by the total number of committee members. Decision is taken by the vote of chairman in tie situation.
  3. Ç.U. F.O.M.-EMRAP takes the task of secretariat duty of Local Ethics Committee.
  4. Researchers have to post their application forms to Local Ethics Committee ten days before the meeting. Forms are posted to every member of committee by copying.
  5. Applications are made by the most senior personnel that is in the position of executive or one of the executives of projects to do. Executive is the researcher that is in the position of advisor for thesis and is in the position of lecturer for other research projects.
  6. Local Ethics Committee can decide as "appropriate", "improvable", "restrictedly appropriate" and "inappropriate" in consequence of evaluation that they make. While the application of any members of Local Ethics Committee, related committee member cannot participate in meeting and cannot vote.
  7. After the approval of project, changes to do on project has to be reported to Local Ethics Committee, essential permission and certification have to be wanted again.
  8. Local Ethics Committee allow the project to start when they return the study of appropriate, Committee can track the study in case of need and sign the certification in the end of study.
  9. Any study with experiment animal cannot be carried out without the permission of Local Ethics Committee. During the implementation of approved project, if violation of codes of conduct is detected by Local Ethics Committee, continuance of experiment is not allowed even if the work permit is obtained in advance and the certificate is not given in the end of study.
  10. All applications and taken decisions are kept in a database. Records are kept open to supervision of Animal Experiments Center Ethics Committee and Ministry.
THE FOURTH CHAPTER
Working Principles of Local Ethics Committee

Working Principles of Local Ethics Committee
ARTICLE 10 – Local Ethics Council works in accordance with the principles stated below:

  1. As the principle of respect to life is accepted as valid for all kinds of animals, to avoid bad application towards experimental animals that are compulsory in scientific researchers,
  2. To ensure that the experimental animals be used as part of provisions stated in the Article 11 of this Regulation,
  3. To ensure that an animal is not used more than once in the experiments which gives severe pain, stress or equal suffering,
  4. To ensure in congress, conference and seminars that painful experiments not to be done with the aim of education,
  5. To ensure that scientifically reliable data is obtained giving less pain to the animal as much as possible and stressing it out in the least,
  6. To prepare convenient conditions to experimental animals used during the researches suitable for its kind and provide the guarantee of best physiologic, behavioral and environmental conditions,
  7. To provide experimental animal care in appropriate conditions by suitably trained staff,
  8. To ensure that experimental studies that will be done on alive animals be in the supervision of a vet or an expert,
  9. To ensure the determination of experimental target points by the researchers,
  10. If there are alternative methods proved their validity in obtaining the studied information, not to see fit the animal experiments ethically and to ensure preventing of repeating the experiments done earlier in detail,
  11. To ensure the selection of the most suitable animal and method for the experiment, to use as few animal as possible that will give the scientific result,
  12. To ensure in experiments that will give unnecessary pain and ache to experimental animals to be applied a suitable anesthesia method, to be used anesthesia with suitable pain killers in the researches,
  13. In the event that the anesthesia being more traumatic than the experiment itself and this experiment's not being fit to the experiment's target to prevent the experiment being done,
  14. To ensure the experiment be done within the frame of ethic principles and to treat the animal that will be exposed to pain considerably when goes out of anesthesia with the painkiller devices in order to be convenient for the aim, if it is not possible killing with a humane method and in the process of research of the experimental animal or at the end of it getting the proceeding of claiming the animal's life with suitable reasons,
  15. To ensure that experimental animals that suffer severely and constantly and that cannot continue their normal life as well as the experimental animals that might pose a risk for public health and its environment to be killed after the vet's decision with the most convenient method in a way that they will not feel pain,
  16. If the animal will be left alive after the experiment, during the process of regaining its health, to provide the convenient care, to ensure that it is in the supervision of a vet who is in charge of animal's rearing, reproduction and care,
  17. When it is reached a conclusion that the experiment is not of enough importance to provide vital needs of humans and animals, to ensure that preventing animal to be exposed to an experiment that is long termed and severe painful,
  18. To guarantee experimental animals that are used in the study and continue living the healthy life conditions after the experiment,
  19. To ensure the experiments in which the animals will be exposed to severe and long termed pain are to be done after found convenient by the Local Ethics Council within the frame of ethic principles.
CHAPTER FIVE
Miscellaneous and Final Provisions

Experiment Animal's Aims of Being Used
ARTICLE 11 – Experimental animals;

  1. Disease, unhealthiness or other anomalies in humans, animals, plants and avoiding, preventing, diagnosis, treatment of these effects or with the aim of evaluation, fixation, arrangement or changing of behavioral characteristics of beings in question, development, manufacturing, quality, efficiency and security tests of medicines, vaccines, foods other material and products to be done
  2. To determine, arrange and change the physiologic mechanisms of human, animal and plants,
  3. To protect the natural environment for the benefit of human or animal's health or well-being,
  4. Education
  5. forensic investigation
  6. It can be used for the evaluation, detection, and arrangement or changing of behavioral characteristics of humans, animal or plants.
Application Form of Experimental Animal User
ARTICLE 12 - To the protocol prepared about the researches done on experimental animals the application form which involves information below is filled up in three copy and the copy of "Ethic Rules and Principles Required in the Research and Training of Experimental Animals" text prepared by Local Ethics Council and signed by all the researchers joining the study is added.

  1. In the event of practical applications related to experimental animals done in any department other than ÇÜTF-DETAUM, warrant from the departments in which the study will be done,
  2. Name of the researcher
  3. Title, address and signs of the researchers,
  4. If there is any, name, address of the institution and signs of the officials,
  5. Research summary,
  6. Articles on the research previously published,
  7. Aim of the researcher
  8. Material and method, detailed explanation of methods that will be used in animals and all kinds of chemical interference,
  9. Kinds, breed, genders, numbers of the to be used experimental animals, the source that the animals are produced,
  10. Anesthesia method, if it is to be applied analgesia method,
  11. If necessary euthanasia method,
  12. Approximate starting date and due dates of the research,
  13. Measurement and evaluation methods,
  14. Measure of ending the research (pain and discomfort),
  15. Evaluation and statistical methods to be used,
  16. Sources
Responsibility of the Applicants
ARTICLE 13 – In the application for Local Ethics Council researchers:

  1. The validity of all the information they give in the application form,
  2. Without Local Ethics Council's consent they will not start the experiments about the projects,
  3. To do proceedings to be done in experimental animals in accordance with the principles stated in the application form and to open labs and working orders to council members in case the ethic council wants to see,
  4. Researchers are assumed to accept at the end of the research that they will give information to Local Ethics Council in written and will hide the documents related to the research for five years period in order to present in case of Local Ethic Council's demand.
Training of Staff that will study with the experimental animal
ARTICLE 14 - The principles that the staff who study with experimental animal needs to obey are stated below
  1. Local Ethics Council is responsible for the arrangement of training programs for the education of researchers that study and/or will study with experimental animals, opening, arrangement and conduct of lab animals use certificate programs. Those who have been successful in this programs are given experimental animal use certificate by Local Ethics Council.
  2. Experimental animal users, without getting certificate, cannot operate on these animals with the aim of experiment, education, and test and cannot shelter these animals in working places.
  3. YLocal Ethics Group prepares vocational training program that includes procedure and principles that the staff who is in charge of experimental animal's production and rearing to be informed at least and to be obeyed and supervises its application periodically. Training programs are conducted by authorized people. Local Ethics Council determines who the authorized people in the institution are.
  4. In studies that are presented to the consent of Local Ethics Council, in the event of experiment animal user's not having a certificate, his/her studies are not approved by Local Ethics Council.
  5. One researcher, in the event of not having his own certificate can apply to Local Ethics Council as a research conductor in order to cooperate with other people. Researchers that participates themselves but do not directly operate with experimental animals can continue their experiments with the help of the certificated experimental animal users.
  6. How to conduct the certificate programs are determined by Local Ethics Committee.
  7. "Experimental Animals Use Certificate" is given to trainees that have registered to experimental animals use certificate programs arranged according to the provisions of this Regulation and met the conditions of success. Experimental animals use certificate is signed by Local Ethics Committee Chairman.
  8. Central Ethics Council decides whether experimental animal use certificates from other institutions or the like are equal to the provisions of this Regulation.
  9. Local Ethics Council decides whether the training received about experimental animal use at the level of undergraduate/graduate is equal to certificate program.
SUPERVISION AND SURVEILLANCE
ARTICLE 15 - 5199 no: Local Ethics Council's correspondences are confidential and information will not be given to the third persons except the authorized body. Current Local Ethics Council approvals are valid during the period given. For the projects that are not finished, extra time can be required.

Providing of Animals
ARTICLE 16 – Animals must be obtained from a source that is approved by ÇÜTF-DETAUM Experimental Animals Rearing and Research Unit or Local Ethics Committee. Birth date and stock of every reverberated animal that is used in research has to be registered. Wild kinds of animal cannot be used in research. But in special conditions and in circumstances that there is no alternative option, these animals can be used with the special permission of local ethics committee. Production has to be organized in the way providing the research requirements such as number, sexuality, weight, health etc. Especially over birth and unnecessary separation should not be performed. In animals that are not rodent’s big surgical interventions must be done only in the ÇÜTF-DETAUM Experimental Animals Unit. Animal experiments on rodents and animal experiments done except ÇÜTF-DETAUM Experimental Animals Unit have to be performed with the permission and custody of local ethics committee in the place where is determined beforehand.

States which there is no provision in the regulation
ARTICLE 17 – About the provisions that do not include in this directive, provisions of the regulations related to Ministry of Environment and Forestry are based on.

Enforcement
ARTICLE 18 - This instruction goes into operation when The University Senate approves.

Executive
ARTICLE 19 - Rector of Cukurova University conducts this directive.