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RULES AND GUIDELINES FOR RESPONSIBLE CONDUCT OF RESEARCH WITHEXPERIMENTAL ANIMALS

Nis, July 2007

Pursuant to the Article 55. of the Statute of the Faculty of Medicine in Nis and in connection with Article18 of the Law on Animan Health Protection (Official Recordings RS, No 37/91, 50/92,33/93,52/93,53/95, 52/96 i 25/2000), Articles 37-40 of the Law on Environmental Protection (OfficialRecordings RS, br.66/91, 83/92 i 53/95), Direction 86/609/EEC (1986) of the EU Council and theEuropean convention on the Protection of Vertebrates used for Experimental and Other ScientificPurposes (1990), the Ethics Committee of the Faculty of Medicine in Nis adopted the following

RULES AND GUIDELINES FOR RESPONSIBLE CONDUCT OF RESEARCH WITHEXPERIMENTAL ANIMALS

I GENERAL PROVISIONS

Article 1

RULES AND GUIDELINES FOR RESPONSIBLE CONDUCT OF RESEARCH WITH EXPERIMENTAL ANIMALSof the Faculty of Medicine in Nis (Rules, further in the text) defines protected animal species,

experimental procedures (ethical and unethical), principles of ethical experimental work with animals,traning of the researchers for such work, Ethical Committee for Work with Experimental Animals of theFaculty of Medicine in Nis (its tasks, work principles, composition and way of forming, Ethical Committeefurther in the text), procedure of getting the licence to work with experimental animals by the EthicalCommittee, as well as the procedures in case of neglect of the rules set by the Ethical Committee anddecisions adopted based on the Rules.

II PROTECTED ANIMAL SPECIES AND EXPERIMENTAL PROCEDURES

Article 2

Protected species are vertebrates (experimental animals further in the text), except for the humans,including all developmental stages from the middle of gestation.

Article 3

Ethical experimental procedures are those that involve the procedures of manipulation of experimentalanimals aiming to obtain new knowledge in the biomedicine field and thus to contribute to generaldevelopment of medicine and which could cause suffering, pain and permanent disability ofexperimental animals (disease, injury, stress etc).

Article 4

Ethical experimental procedures involve also the purposeful sacrificing of experimental animals in orderto get isolated organs or sacrificing at the end of experiment.Sacrificing methods must not cause suffering and pain. Death has to be instantaneous (the procedureswhich satisfy these criteria are the administration of triple dose of an intravenous anesthetic, inhalationof appropriate mixture of gases in special chambers, cervical dislocation, decapitation etc).

Article 5

Non-ethical experimental procedures are those manipulations with experimental animals which couldcause pain, suffering, permanent damage or death, and are not aimed at creating new knowledge inbiomedical sciences and do not contribute to the development of medicine. Among these procedures wemay include demonstrations of already known facts on experimental animals, except when theinvolvement of animals is unavoidable for the achievement of educative goals. Instead of this, computersimulations or other didactic devices are recommended. The use of animals in practical teaching, inexceptional cases when educational goals cannot be achieved otherwise, is possible at the Faculty ofMedicine in Belgrade after the request of the performing teacher and the aprovement of the departmentin question, only with special permission of the Ethical Committee (issued for specific time) and withrespect to the stipulations of the Rules.

Article 6

The Rules does not consider the procedures of marking of experimental animals which can causemomentary pain, investigation of new veterinary agents and other veterinary diagnostic and treatment

procedures.


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Article 7

In planning experimental work with animals it is necessary to respect the following ethical principles.Principle of replacement: whenever possible instead of experimenting on a protected species, we shoulduse alternative experimental models in vitro (eg. cell cultures, isolated organs, microorganisms) andcomputer simulations; Principle of reduction: using the smallest possible number of experimentalanimals, according to the statistical requirements; Principle of quality: use of healthy animals,appropriate species and age, properly kept and if possible in kinship. It is mandatory to use appropriatestatistical methods in the evaluation of results. Only appropriately trained investigators should be

included in experimental work with animals. Experimental protocols have to predict scientifically validanswer to the research goals.

III RESEARCHERS

Article 8

Researchers should be appropriately trained to work with experimental animals. The requiredqualification degree depends on the experimental protocol itself. Researchers have to submit theconfirmation that they are trained to work with experimental animals. This could be a certificate of thecourse attended at the Faculty of Medicine or any related scientific/research institution in the country orabroad, with similar or more strict regulations from those contained in the Rules. Experiencedresearchers can prove their competence submitting their already published papers in the journals fromdeveloped countries, including the EU countries.

Experimental SubjectsAll studies involving human subjects or human tissue must be in accordance with the principles set outin the Declaration of Helsinki and must have been formally approved by the appropriate institutionalreview board, ethical review committee, or equivalent. All manuscripts should indicate that suchapproval was obtained. The study populations should be described in detail. In many studies details ofage, race, and sex are important. In experiments involving any significant risk or discomfort to subjects,it should be documented that informed consent was obtained from the subjects and that an institutionalhuman research committee had approved the investigations. In text, tables and figures of subjectsmust be identified by number or letter rather than by initials or names. Photographs of patients' facesshould be included only if scientifically relevant. Authors should obtain written consent from the patientfor use of such photographs.

ETHICAL GUIDELINES FOR PUBLICATION OF RESEARCH IN ACTA FACULTATIS MEDICAENAISSENSIS

The Editorial Board is keenly aware of the importance of formulating and disseminating rules of goodconduct for authors, reviewers, and editors. Equally important is the establishment of due process foralleged or apparent improprieties. The Ethical Committee of The Faculty of Medicine, University in Nishas approved the following Ethical Guidelines for our Editorial Board, reviewers, and authors submittingmanuscripts. The following statement is not meant to be all-inclusive but is provided in sufficient detailto give a clear understanding of ethical considerations to all concerned.

IntroductionThe fundamentals of good conduct as they apply to research are honesty, fairness, good manners, andthe subordination of self-interest to the common interest of our profession and our society. In thesenotes, the Editorial Board sets forth its rules of good conduct for authors, reviewers, and editors.

Obligations of AuthorsAuthorship ConditionsAn author should have participated in either the conception or planning of the work, the interpretationof the results and the writing of the paper. An acknowledgment accompanying the paper is appropriaterecognition for others who have contributed to a lesser extent, e.g., provision of clones, antisera or celllines, or reading and reviewing manuscripts in draft. The signature of each author on the Affirmation ofOriginality and Copyright Release form that must be submitted with the manuscript indicates that allauthors have had a part in the writing and final editing of the report, all have been given a copy of themanuscript, all have approved the final version of the manuscript, and all are prepared to take publicresponsibility for the work, sharing responsibility and accountability for the results.

Authorship Obligations

The foremost obligation of an author is to present a clear, honest, accurate, and complete account ofthe research performed. Each manuscript should describe a complete study or a completed phase of anextended study. Fragmentation of reports should be avoided. When some of the results are to appear inanother journal, in publications of congresses, symposia, workshops, etc., details plus a copy of the


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other paper(s) should be supplied to the editor. Any preliminary accounts or abstracts of the work,already published, must be referenced in the complete report.The author has an obligation to: 1) describe the work in sufficient detail to allow others to repeat thework; 2) adhere to the journals' policy regarding preparation of digital images as outlined below; 3)include all relevant data, including those which may not support the hypothesis being tested; 4) citethose publications which have a direct bearing on the novelty and interpretation of the results; 5) makeunique resources available to other investigators for academic research purposes, as a condition ofpublication. The Faculty of Medicine endorses the philosophy of open exchange of research materials

and requires this; 6) ensure no substitution, addition, or deletion of data or text during the proofcorrection process (after acceptance). Answers to author queries and changes to typographical orprinter's errors may be made to proofs. Any other changes will require that the proofs be returned tothe editorial office for re-review of the manuscript; 7) If there are any additions, deletions, or changesin position of the names that appear in the authorship line of the originally submitted manuscript, thecorresponding author must send to the Editorial Board a brief letter, signed by all authors, stating thatthey agree to the change.

Image IntegrityWhen preparing digital images, authors must adhere to the following guidelines (as stated in Reference 8):

No specific feature within an image may be enhanced, obscured, moved, removed, orintroduced.

Adjustments of brightness, contrast, or color balance are acceptable if they are applied to the

entire image and as long as they do not obscure, eliminate, or misrepresent any information present inthe original.

The grouping of images from different parts of the same gel, or from different gels, fields, or

exposures must be made explicit by the arrangement of the figure (e.g., dividing lines) and in the figurelegend.

Deviations from these guidelines will be considered as potential ethical violations.Note that this is an evolving issue, but these basic principles apply regardless of changes in the

technical environment. Authors should be aware that they must provide original images when requestedto do so by Editors-in-Chief who may wish to clarify an uncertainty or concern.

Prior Publication

Failure to notify the editor that some results in the manuscript are being or have been previouslypublished will result in placement of a notice in the journal that the authors have violated the Ethical

Guidelines for Publication of Research in The Acta Facultatis Medicae Naissensis. The journal publishes

original research and review material. Material previously published in whole or in part shall not beconsidered for publication. This includes materials published in any form of mass communication. At thetime of submission, authors must divulge in their cover letter all prior publications or postings of the

material in any form of media. Abstracts or posters displayed for colleagues at scientific meetings neednot be reported. Other postings of any part of the submitted material on web pages, as well as those

essential for participation in required registries will be evaluated by the Editor-In-Chief, who shalldetermine if those postings are material enough to constitute prior publication.

Copyright Assignment and Affirmation of Originality

Acceptance and publication of any article in the medical journal Acta Facultatis Medicae Naissensis iscontingent upon the author's warranty that the manuscript has not been published in total or in part,

nor is it being submitted or considered for publication in total or in part elsewhere. In addition, theacceptance of any work for publication in Acta Facultatis Medicae Naissensis is contingent upon the

author's assignment and transfer of rights and interest in and the copyright of that work in its currentform.

This is to confirm that I am acquainted with the rules of ethical code on the work with humans andexperimental animals and that I respected these principles in my scientific and clinical investigation.

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