SELÇUK UNIVERSITY EXPERIMENTAL MEDICINE APPLICATION AND RESEARCH CENTER

ANIMAL EXPERIMENTS LOCAL ETHICS COMMITTEE DIRECTIVE

FIRST PART

Purpose, Scope, Basis, Definitions and Abbreviations

ARTICLE 1. PURPOSE

The purpose of this directive; It is to determine the establishment, working, and duty principles
 of the local ethics committee for animal experiments, the application procedures of education, 
training, testing and scientific studies to be carried out on experimental animals, the monitoring of 
the housing, production, transportation conditions of experimental animals and the recording of all 
procedures.

ARTICLE 2. SCOPE

It covers the evaluation of education, training, testing and scientific studies in terms of animal 
ethics in Selcuk University Experimental Medicine Application and Research Center, the establishment
 of the Selcuk University Experimental Medicine Application and Research Center Animal Experiments
 Local Ethics Committee, working procedures and principles.

ARTICLE 3. BASIS

Animal Protection Law No. 5199, Regulation on Working Procedures and Principles of Animal
ExperimentsEthics Committees published in the Official Gazette dated 15/02/2014 and numbered 28914,
and Experimental and Other Studies published in the Official Gazette dated 13/11/2011 and numbered 
28141. It has been prepared based on the Regulation on the Welfare and Protection of Animals Used
for Scientific Purposes.

ARTICLE 4. DEFINITIONS AND ABBREVIATIONS

a) Rector: Rector of Selcuk University,

b) Ethics Committee: Evaluating the operations to be carried out with experimental animals in basic
activities such as scientific research, testing, medical practices and education at Selçuk 
University Experimental Medicine Application and Research Center within the framework of ethical
principles, expressing opinions, examining the proposed protocols, giving permission, monitoring 
the practices, Selcuk University Animal Experiments Local Ethics Committee, which ensures that all
procedures performed on experimental animals are recorded and these processes can be traced 
instantly or retrospectively,

c) CITES Convention: The Convention on International Trade in Endangered Species of Wild Animals and
Plants published in the Official Gazette dated 20/6/1996 and numbered 22672,

ç) Work permit: The document given by the Ministry of Food, Agriculture and Livestock in order for 
the experimental animal user, producer and supplier organizations to start operating,
d) Experiment: Any procedure or set of procedures to be performed on animals for scientific purposes,
e) Experimental Animals Research and Breeding Unit: The unit established in accordance with the
principles regarding the breeding and housing of experimental animals in the relevant regulations 
of the Ministry of Forestry and Water Affairs and the Ministries of Food, Agriculture and Livestock,
f) Experimental animal: Any non-human vertebrate, including free-living or reproducing larval forms,
living cephalopods and mammals from the last third of their normal fetal development, used in 
procedures,
g) Experiment unit: Units where all kinds of procedures or procedures are carried out on animals and
which have a work permit from the Ministry of Food, Agriculture and Livestock,
ğ) Ethics: Limits of actions that can be taken in sciences concerning human and animal life in
relation to animals to be used in research, universal rules guiding the attitude and behavior 
towards animals,
h) HADMEK: Animal Experiments Center Ethics Committee,
ı) HADYEK: Animal Experiments Local Ethics Committee,
i) Animal welfare unit: At least one person with the title of veterinarian, veterinary health 
technician or veterinary health technician, responsible for the welfare and care of animals, 
obligatory to be established in producers, suppliers, users and institutions authorized to research,
 and a person holding one of these titles in user organizations. a unit consisting of a maximum of 
three people, one of which is a member of the local ethics committee, in addition to the individual,

j) Humane killing method: Ending the animal's life in such a way that it is exposed to the least
 physical and sensory pain, suffering and distress unique to its own species,

k) In vivo experiment: An experiment performed in a live environment,

l) Good laboratory practices: The quality system regarding the planning, conducting, monitoring, 
recording, archiving and reporting conditions and management procedures of health and environmental
 safety studies other than clinical studies,

m) User: Person authorized to use animals in procedures,

n) Establishment: Any open, closed, semi-open, fixed or portable facility, building or group of 
buildings together with its outbuildings, which has a work permit from the Ministry of Food, 
Agriculture and Livestock,

o) Project: A work program with a defined scientific purpose and covering one or more procedures,

ö) Procedure: Animals; Experimental, other experimental, other, with known or unknown consequences,
which, in accordance with good veterinary practice, may cause pain, suffering, suffering, or 
lasting damage equal to or greater than that caused by the insertion of a needle, including the
processes of giving birth, hatching, or maintaining a genetically modified animal lineage. to be
used for scientific or educational purposes,

p) Secretariat: The person or persons who provide the necessary coordination in the ethics
committees, make the correspondence and keep the records,

r) SÜDAM: Selcuk University Experimental Medicine Application and Research Center,

s) Technician: A person who has graduated from the Department of Veterinary Health of the 
Agricultural Vocational High School affiliated to the Ministry of National Education and any of the 
Veterinary Health Vocational High School, Animal Health Officers School, Animal Health Officers 
Vocational High School, which was previously affiliated to the Ministry of Food, Agriculture and 
Livestock,

ş) TÜBİTAK: Scientific and Technological Research Council of Turkey,

t) Species: A biological group that includes related organisms that have common characteristics 
and can reproduce by fertilization among themselves,

u) 3R principle: Wherever possible, apply a scientifically valid alternative method or trial 
strategy instead of live animals, reduce the number of animals to be used as much as possible without
compromising the project objectives, improve the procedures that will cause pain, suffering, 
suffering and permanent damage to animals, increase well-being,

ü) Veterinarian: A person who has successfully completed a five-year training period in Veterinary
 Faculties and received a diploma, and has earned the title of veterinarian in accordance with the
 Law on the Execution of the Veterinary Medicine Profession dated 9/3/1954 and numbered 6343,
 the Organization Style of the Turkish Veterinary Medical Association and its Chambers and the Jobs
 to be Performed, means.

SECOND PART

Establishment, Working Method, Duties, Powers and Principles of the Ethics Committee

ARTICLE 5. FOUNDATION OF THE ETHICS COMMITTEE

(1) The Local Ethics Committee consists of thirteen members whose qualifications are stated below:

a) Director of Experimental Medicine Application and Research Center; He is the chairman of HADYEK.

b) Deputy chairman to be elected from the Deputy Director of the Experimental Medicine Application 
and Research Center,
c) A veterinarian who works in the Experimental Medicine Application and Research Center, is
responsible for raising, production and care of experimental animals, has a certificate of use 
of experimental animals, works in the unit full time, and has at least one year experience in animal
experiments,

ç) A citizen of the Republic of Turkey registered with a non-governmental organization who has no
interest in the institution,

d) T.R., who has no interest in the institution, who or his relatives do not work with experimental
animals, and who can represent the interests of the society. a citizen,

e) Eight faculty members whose cadres are in at least three of the units of the university that work
with experimental animals. At least six of these faculty members must have at least one study with
experimental animals, and one of them must have at least one year of experience in in vivo animal 
experiments.

(2) The Ethics Committee may seek opinions from experts in other fields and/or invite them to 
meetings when necessary.

(3) The President, Deputy Chairman and members of the Ethics Committee, who are Selçuk University 
personnel, are assigned by the Rector. The member affiliated to the non-governmental organization 
and the non-governmental member who will serve in the Ethics Committee are elected by the Rector.

(4) The term of office of the members of the Ethics Committee is four years. A member whose term of
 office has expired can be reassigned. The membership of a member who does not attend three
 consecutive meetings without permission and excuse within a calendar year is automatically 
terminated. In case of termination of membership or termination of membership for any reason such 
as death, retirement, resignation, a new member who has the same qualifications as the resigned
member is elected/assigned in the same manner and to complete the remaining term.

(5) Persons who are found to have acted contrary to the provisions of the Regulation on 
Working Procedures and Principles of Animal Experiments Ethics Committees cannot be appointed to the 
SÜDAM Local Ethics Committee.

(6) Appointments or changes made with approval are notified to HADMEK within one month.

(7) After the Local Ethics Committee directive is approved by HADMEK, it starts its activities.

ARTICLE 6. WORKING METHOD OF THE ETHICS COMMITTEE

(1) The Ethics Committee convenes at least once a month and with the participation of at least
 two-thirds of the members, with the agenda to be determined by the chairman.

(2) Ethics Committee meetings are held under the chairmanship of the vice chairman in the absence 
of the chairman.

(3) Ethics Committee decisions are taken with one more than half of the total number of members. 
In case of equality of votes, the decision is made in the direction of the chairman's vote.

(4) The local ethics committee establishes its own secretariat. The local ethics committee may 
establish sub-committees if necessary.

(5) Records of all experimental animals used in SÜDAM are kept or kept by the veterinarian who is
 responsible for the breeding, production and care of experimental animals in the animal welfare
 unit. The number of animals supplied, their species, the places where they were procured, the date
 the user came to the organization and all the transactions carried out are included in the said
 records. These records are kept for at least five years.

(6) HADYEK prepares the application form (Annex-1) and the letter of undertaking (Annex-2).

(7) Users of experimental animals cannot operate on these animals for the purpose of experimentation,
training or testing, and cannot house these animals in their working places without obtaining a
certificate. It is obligatory to have a veterinarian in the research team team in researches to be
carried out with farm animals. In this case, it is not necessary for the veterinarian to have a 
certificate for the use of experimental animals. In the study submitted for HADYEK approval, if the
person using the experimental animal does not have a certificate of use, this study is not approved.

(8) For the application made, HADYEK decides as a result of its evaluation as appropriate, needs
to be corrected, conditionally appropriate or not appropriate.

(9) The decision of HADYEK is notified to the applicant in writing within forty working days from 
the date of application. This period also includes project evaluation. In cases where the complexity
of the project or it concerns more than one discipline, HADYEK may extend the aforementioned period
for once, not exceeding fifteen working days. Executor is informed before the expiry of the 
extension, by justifying the reason and duration of the extension.

(10) Projects are allowed for a maximum period of five years. In case of an extension request,
additional time may be granted provided that the request is justified.

(11) All applications and decisions taken are recorded by giving the date and number. Records are 
retained for at least five years.

(12) HADYEK may request preliminary experiments on a small number of animals to test the feasibility
of a project. In this case, the final decision is made according to the procedures in the projects 
for which the "conditionally appropriate" decision is given.

(13) Authorized projects can be audited by the local ethics committee for animal welfare and 
compliance with the approved project. The Local Ethics Committee cancels the permission given 
when an application or any change in the approved project is detected that will adversely affect 
the animal welfare. In case the permission is cancelled; It is ensured by the animal welfare unit
that the welfare of the animals used or anticipated to be used in the project is not adversely
affected.

(14) The change to be made in the project, for which HADYEK approval has been received, is notified
to HADYEK in writing by the project coordinator, and if HADYEK approves, the project change is made.

(15) Records are kept open for inspection by HADMEK and the Ministry of Forestry and Water Affairs.
HADYEK can get the written opinions of experienced experts when necessary, or invite them to a 
HADYEK meeting and request oral or written opinions.

ARTICLE 7. AUTHORITIES AND PRINCIPLES OF THE ETHICS COMMITTEE

(1) Powers of the Ethics Committee; All applications to be made on experimental animals at Selçuk
University Experimental Medicine Application and Research Center must be approved by the SÜDAM 
Ethics Committee. Studies that are not approved by the Ethics Committee cannot be carried out within
the body of Selcuk University Experimental Medicine Application and Research Center.

(2) The Ethics Committee works in line with the following principles:

a) To prevent mistreatment of experimental animals during production, breeding and experimental work
processes at SÜDAM.

b) To ensure the use of experimental animals for the purposes stated below.

The study, identification, correction or modification of human or animal physiological disorders.
Improvement of animal welfare and production conditions of animals raised for agricultural purposes.
Developing, manufacturing and testing the quality, efficacy and safety of pharmaceuticals, food raw 
materials, feedstuffs, other substances and products. Protection of the natural environment for 
human and animal health and welfare.
Research aimed at species conservation. Higher education or training to acquire, maintain or develop
professional skills.

c) To ensure the use of methods that will minimize pain in the procedures to be performed on 
experimental animals.

ç) Absence of painful and painful practices in educational congresses, conferences and seminars.

d) To prepare the conditions suitable for the type of experimental animals and to provide the best
 physiological, behavioral and environmental conditions.

e) To ensure that experimental studies on live animals are carried out under the supervision of a 
responsible veterinarian.

f) Experimental animal care is carried out under appropriate conditions by personnel who have 
received adequate training.

g) To ensure that the experimental target points (end points) are determined by the investigators,

ğ) If there is an alternative in vitro method, the animal experiment is not ethically approved and 
the experiments that have been done in detail before are not repeated on animals.

h) To ensure that the most appropriate animal species and method are selected for the experiment and
that the least number of animals that can produce scientifically meaningful results are used.

ı) To ensure that the appropriate anesthesia method is applied in experiments that will cause 
unnecessary pain and pain to experimental animals, and that appropriate painkillers and anesthesia 
are used in researches.

i Failure to perform anesthesia if it is more traumatic to the animal than the experiment itself and
 is not suitable for the purpose of the experiment.

j) With the decision of the veterinarian, in order for the experiment to be carried out within the
 framework of ethical principles and to be suitable for its purpose;

1) The animal that will be exposed to significant pain when it comes out of anesthesia should be 
treated with painkillers, if it is not possible to be treated, it should be killed with a humane 
method,

2) The process of ending the life of the experimental animal during or at the end of the research is
 carried out for appropriate reasons,

3) To ensure that the experimental animals that suffer from severe and constant pain or that cannot 
maintain their normal life and that may pose a risk to their health and environment are put to an 
end with a humane method.

k) To provide healthy living conditions for the experimental animals used in the research as long as
they live.

l) To decide not to carry out experiments that will expose animals to severe, long-term pain and 
that cannot be corrected, if the benefit to be obtained from the research is important, taking into
account the ethical principles and the suffering of the animals.

m) To reduce the number of animals used in the experiment by making more than one application on 
animals, as long as the scientific goal is not deviated and the welfare of the animal is not
deteriorated.

n) To ensure that the tissues and organs of animals that died in the experiment are evaluated in
other applications within the scope of sharing.

o) To allow procedures to be carried out under the supervision of SÜDAM animal welfare unit.

ö) Encouraging the design and implementation of practices that will contribute to human and animal 
health, increase knowledge, or be for the good of society

ARTICLE 8 . DUTIES OF THE ETHICS COMMITTEE

a) Approving or rejecting the protocols regarding the procedures to be carried out by determining 
the ethically acceptable limits of the applications to be made and all the procedures to be 
performed on the experimental animals.

b) Supervising the continuation of the process of using experimental animals in SÜDAM in accordance 
with the 3R principles and ethical rules, and making the necessary arrangements for this purpose.

c) To make practices that may provide the same or higher level of information than those obtained 
using experimental animals, but that will contribute to the development and validation of 
alternative methods that do not use animals or that involve less painful procedures and that
encourage research in this field.

ç) To ensure that the procedures to be performed on experimental animals are carried out in 
accordance with the approved protocol, and to decide to terminate them when necessary.

d) To ensure that the personnel who will work with experimental animals at SÜDAM receive the 
necessary training and to allow animal experiments to be carried out, provided that they have an 
experimental animal usage certificate. To organize certificate programs when necessary for this 
purpose.

e) To control whether the production, breeding, housing and transportation conditions of the 
experimental animals and the laboratory conditions and equipment in which the experiments are 
carried out are ethically appropriate.

f) To prepare statistical data tables and annual activity report regarding the use of experimental 
animals and submit them to HADMEK.

g) To ensure the disposal of wastes and medical wastes resulting from experimental studies in 
accordance with the Environmental Law No. 2872 dated 9/8/1983 and the relevant legislation.

ğ) To ensure that experimental animals are registered and monitored within the framework of the 
provisions of the Animal Protection Law No. 5199 and the relevant legislation.

h) Notifying HADMEK of the training certificate programs to be organized thirty days in advance.

ı) To inform HADMEK about the certificate training programs they organize and the trainees who have 
successfully received certificates at the end of the training.

THIRD PART

Applications Related to Experimental Animals and Research

ARTICLE (1) Experimental Animal




Unless there is a general or special exception taken in accordance with the regulations made by 
HADYEK, it is required that the Mouse, Rat, Rabbit, Guinea pig and Hamster species to be used in 
the studies at Selcuk University Experimental Medicine Application and Research Center have been 
purchased from registered legal experimental animal producers and suppliers.




(2) Anesthesia and administration of anesthesia




a) Procedures are performed under general or limited anesthesia, unless there is an unsuitable 
situation for the use of anesthesia. If necessary, analgesia or other methods that allow pain, 
suffering and distress to be minimized can be used. Procedures involving serious injuries that can 
cause severe pain are not performed without anesthesia.




b) In the use of anesthesia, it is taken into account whether the anesthesia is more traumatic for 
the animal than the procedure and whether the anesthesia is suitable for the purpose of the 
procedure.




(3) Animals should not be given any other drug other than anesthetic or analgesic in order to 
prevent them from feeling pain. If a situation to the contrary occurs, a scientific justification 
shall be provided for the details of the anesthetic or analgesic regimen.

4) Once the anesthetic wears off, an animal in distress is treated with analgesics or other pain 
relievers during and after surgery, provided the procedure is suitable for its purpose.

5) As soon as the procedure achieves its goal, appropriate action is taken to minimize the animal's 
distress.




(3) Classification of Violence in Killings and Experiments




a) At the end of the procedure, the decision regarding the survival of the animal is made by the 
veterinarian. At the end of the procedure, if the animal will continue to live with moderate or 
severe pain, suffering, distress and permanent damage, it is decided to kill it by the appropriate 
method.

b) All procedures are classified on a case-by-case basis as mild, moderate, severe or unrecoverable.
The classification of violence is made as stated in the "Regulation on the Welfare and Protection of
Animals Used for Experimental and Other Scientific Purposes".




(4) Reuse of animals in experiments




a) If the actual severity of previous experiments was “mild” or “moderate”,

b) If the general health condition of the animal is completely restored,

c) If the new test is classified as "mild", "moderate" or "uncorrectable",

ç) If approved by a veterinarian who can evaluate the previous procedures performed on the animal,

2) In exceptional cases, an animal may be allowed to be reused provided that the animal is not used 
more than once in an experiment involving severe pain, suffering or the equivalent, excluding 
subparagraph (a) and after the animal has been examined by a veterinarian.

(5) Termination of the experiment

The experiment is terminated when no further observations can be made of the experiment, or if the 
genetically modified animal strains and progeny are no longer traced, or if they are expected to 
experience pain, suffering, suffering, and permanent damage equivalent to or greater than an 
ongoing needle stick.

(2) At the end of the experiment, the decision on the survival of an animal is taken by a 
veterinarian. In case an animal continues to be kept alive, care and shelter services are provided 
in accordance with its health condition. If the animal continues to experience moderate or severe 
pain, suffering, suffering and permanent damage, it is killed.




CHAPTER FOUR

Education

ARTICLE 10.




1) The Training Certificate Program will be organized in accordance with the Experimental Animal Use
Certificate Training Program specified in the Circular No. 2007/11 published by the Ministry of 
Forestry and Water Affairs on 12.12.2007.

2) "Experimental Animal Use Certificate" is given to the trainees who fulfill the attendance and 
success conditions by registering in the experimental animal use certificate programs organized in 
accordance with the provisions of this Regulation. Experimental animals use certificate is signed by
the head of HADYEK and the rector of universities.

3) HADYEKs are obliged to inform HADMEK about the certificate training programs they will organize 
thirty days in advance.

4) HADYEK provides training of the personnel in charge by preparing training programs on care, 
feeding and ethical issues.

CHAPTER FIVE

Application to the Ethics Committee, Evaluation and Decision

ARTICLE 11 . APPLICATION

(1) It is obligatory to obtain the approval of the Ethics Committee for all kinds of research 
projects, thesis (specialization, science specialization and doctorate) studies to be carried out 
within the body of Selcuk University Experimental Medicine Application and Research Center, animal 
experiments and observations, and educational applications.

(2) Ethics Committee applications are submitted to the Committee Secretariat together with the 
"Animal Experiments Local Ethics Committee Application Form". Applications must be made by the 
"Consultant Faculty Member" in the capacity of "Executive" in thesis studies, and by the "Project 
Executive" who has a doctorate or equivalent degree in other research projects.

ARTICLE 12. EVALUATION OF APPLICATIONS AND DECISION

Applications determined to be duly made are forwarded by the secretariat to the reporter(s) 
determined by the President of the Ethics Committee for review. The reporter(s) notifies the result 
of the examination regarding the application to the Ethics Committee secretariat within 30 days. 
Following the rapporteur's preparation of his opinion, the application is put on the agenda and 
evaluated at the first Ethics Committee meeting. It is decided as appropriate, needs to be 
corrected, conditionally appropriate or not appropriate. A final decision on the application is made 
and the applicant is notified. This period does not exceed 45 days. HADyEK may give an additional 15
days for once, if a detailed examination is required. While the applications belonging to the 
members of the Ethics Committee are being discussed, the relevant committee member cannot 
participate in the discussions and cannot vote.

Applications that are decided to be corrected are re-evaluated by the Ethics Committee after they 
are corrected by the applicant. Projects with a conditionally appropriate decision are followed for 
a period to be determined by the Ethics Committee, and after evaluating whether the required 
conditions are fulfilled, they are decided as appropriate or unsuitable.

After the approval of the Ethics Committee in the experimental research project, changes in the 
project and the people who will participate in the study are notified to the Ethics Committee in 
writing and its approval is obtained.

In the publication of the studies, it will be stated that YEK approval has been obtained or the 
local ethics committee principles have been complied with.

CHAPTER SIX

Miscellaneous and Final Provisions

ARTICLE 13. REGISTRATION

SÜDAM Registration and identification of experimental animals is carried out in accordance with 
Articles 34, 35 and 36 of the Regulation on the Welfare and Protection of Animals Used for 
Experimental and Other Scientific Purposes, published in the Official Gazette dated 13/12/2011 and 
numbered 28141 by the Ministry of Food, Agriculture and Livestock. makes. The records contain the 
information determined in the statistical forms requested by the Ministry in line with the decision 
of HADMEK.

ARTICLE 14. PRIVACY

Ethics Committee correspondence is confidential and no information is given to third parties other 
than the authorized institutions specified in the relevant Regulation.

ARTICLE 15. ENFORCEMENT

This Directive enters into force on the date it is accepted by HADMEK.

ARTICLE 16. EXECUTION

The provisions of this Directive are executed by the Rector of Selcuk University.